Table of Contents
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 20-F
◻ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
⌧ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2025
◻ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
◻ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of event requiring this shell company report
Commission file number 001-35193
GRIFOLS, S.A.
(Exact name of Registrant as specified in its charter)
Kingdom of Spain
(Jurisdiction of incorporation)
Avinguda de la Generalitat, 152-158
Parc de Negocis Can Sant Joan
Sant Cugat del Vallès 08174
Barcelona, Spain
(Address of principal executive offices)
David Ian Bell
Chief Corporate Development Officer
Telephone: +34 93 571 02 21
Email: david.bell@grifols.com
Grifols Shared Services North America, Inc.
2410 Grifols Way
Los Angeles, CA 90032-3514
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
Securities registered or to be registered, pursuant to Section 12(b) of the Act.
Title of each class
Trading Symbol
Name of each exchange on which registered
American Depositary Shares
evidenced by American Depositary
Receipts, each American
Depositary Share representing
one Class B non-voting
share of Grifols, S.A.
GRFS
The NASDAQ Stock Market LLC
Securities registered or to be registered pursuant to Section 12(g) of the Act.
None.
(Title of Class)
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act.
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.
426,129,798 Class A Shares
261,425,110 Class B Shares
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
⌧ Yes ◻ No
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
◻ Yes ⌧ No
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ⌧
Accelerated filer ◻
Non-accelerated filer ◻
Emerging growth company ◻
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. ◻
†The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes - Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
U.S. GAAP ◻
International Financial Reporting Standards as issuedby the International Accounting Standards Board ⌧
Other ◻
If “Other” has been checked in response to the previous question indicate by check mark which financial statement item the registrant has elected to follow.
◻ Item 17 ◻ Item 18
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
TABLE OF CONTENTS
I
GENERAL INFORMATION
III
PRESENTATION OF FINANCIAL AND OTHER INFORMATION
PRESENTATION OF MARKET INFORMATION
IV
PART I
1
Item 1.
IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
A.
Directors and Senior Management
B.
Advisers
C.
Auditors
Item 2.
OFFER STATISTICS AND EXPECTED TIMETABLE
Offer Statistics
Method and Expected Timetable
Item 3.
KEY INFORMATION
[Reserved]
Capitalization and Indebtedness
Reasons for the Offer and Use of Proceeds
D.
Risk Factors
Item 4.
INFORMATION ON THE COMPANY
42
History of and Development of the Company
Business Overview
45
Organizational Structure
78
Property, Plant and Equipment
E.
Regulatory Matters
81
Item 4.A.
UNRESOLVED STAFF COMMENTS
95
Item 5.
OPERATING AND FINANCIAL REVIEW AND PROSPECTS
Operating Results
96
Liquidity and Capital Resources
109
Research and Development, Patents and Licenses
128
Trend Information
Critical Accounting Estimates
129
Item 6.
DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
Compensation
138
Board Practices
143
Employees
149
Share Ownership
150
F.
Disclosure of a Registrant’s Action to Recover Erroneously Awarded Compensation.
151
Item 7.
MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
Major Shareholders
Related Party Transactions
153
Interests of Experts and Counsel
157
Item 8.
FINANCIAL INFORMATION
Consolidated Statements and Other Financial Information
Significant Changes
159
Item 9.
THE OFFER AND LISTING
Offer and Listing Details
Plan of Distribution
Market
160
i
Selling Shareholders
164
Dilution
Expense of the Issue
Item 10.
ADDITIONAL INFORMATION
Share Capital
Memorandum and Articles of Association
165
Material Contracts
176
Exchange Controls
Taxation
177
Dividends and Paying Agents
185
G.
Statement by Experts
H.
Documents on Display
I.
Subsidiary Information
J.
Annual Report to Security Holders
Item 11.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
186
Item 12.
DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
187
Debt Securities
Warrants and Rights
Other Securities
GLOSSARY OF TERMS
189
PART II
194
Item 13.
DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
Item 14.
MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
Item 15.
CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Management’s Report on Internal Control over Financial Reporting
Attestation Report of the Registered Public Accounting Firm
195
Changes in Internal Control over Financial Reporting
Item 16.
[RESERVED]
Item 16.A
AUDIT COMMITTEE FINANCIAL EXPERT
Item 16.B
CODE OF ETHICS
Item 16.C
PRINCIPAL ACCOUNTANT FEES AND SERVICES
196
Item 16.D
EXEMPTION FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES
Item 16.E
PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS
Item 16.F
CHANGES IN REGISTRANT’S CERTIFYING ACCOUNTANT
Item 16.G
CORPORATE GOVERNANCE
197
Item 16.H
MINE SAFETY DISCLOSURE
200
Item 16.I
DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Item 16.J
INSIDER TRADING POLICIES
Item 16.K
CYBERSECURITY
201
PART III
204
Item 17.
FINANCIAL STATEMENTS
Item 18.
Item 19.
EXHIBITS
SIGNATURES
207
ii
As used in this annual report on Form 20-F, unless the context otherwise requires or as is otherwise indicated:
The basis of presentation of financial information of Grifols in this document is in conformity with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB (jointly, “IFRS-IASB”) and other legislative provisions containing the applicable legislation governing our financial information, unless indicated otherwise.
All references in this annual report on Form 20-F to (i) “euro,” “€” or “EUR” are to the common currency of the European Union and (ii) “U.S. dollar,” “$” or “USD” are to the currency of the United States.
The functional and presentation currency of Grifols is the euro. Beginning with the year ended December 31, 2025, we have changed the presentation of our financial statement amounts from thousands of euros to millions of euros. Prior-period amounts have been conformed to the current year presentation. Therefore, all tabular disclosures are presented in millions of euros except share and per share amounts, percentages and as otherwise indicated. Certain monetary amounts and other figures included in this annual report on Form 20-F have been subject to rounding adjustments. Accordingly, any discrepancies in any tables between the totals and the sums of amounts listed are due to rounding.
Changes in accounting criteria and corrections
In the consolidated annual accounts for year ended December 31, 2024, we applied certain corrections related to the accounting classification of the joint operation Biotek America LLC (the “ITK JV”) and the initial treatment of the investment in Shanghai RAAS Blood Products Co. Ltd (“Shanghai RAAS”). These corrections affected the comparative figures for the years ended December 31, 2023 and 2022 and were described in detail in the notes to the financial statements as of and for the year ended December 31, 2024, filed with the annual report on Form 20-F for the year ended December 31, 2024. Our audited consolidated financial statements included in this annual report on Form 20-F already fully incorporate these adjustments and no additional errors or changes in accounting policies have been identified during 2025.
With respect to the ITK JV, we concluded that the arrangement should have been treated as a joint operation from its inception, which required the proportional recognition of the corresponding assets, liabilities, and results. The correction resulted in the recognition, as of December 31, 2023, of the joint operation’s assets and liabilities amounting to €151 million and €191 million, respectively, and in the recognition of a negative adjustment to reserves of €40 million, net of translation differences, corresponding to accumulated losses for fiscal years 2021 and 2022. It also resulted in a reduction in the profit attributable to the parent company of €23 million in 2022 and €17 million in 2023.
As regards Shanghai RAAS, it was identified that in the initial recognition of the investment in 2020, the amount corresponding to the indirect interest in Grifols Diagnostic Solutions Inc. (“GDS”) should have been excluded. In accordance with the applicable accounting policy, this amount should have been recorded against the investment in Shanghai RAAS rather than against reserves. The correction resulted in a reduction in the carrying amount of the investment and in consolidated reserves totaling €457 million, with no impact on the income statement of the affected fiscal years.
See Item 5 of this Part I, “Operating and Financial Review and Prospects—A. Operating Results—Factors Affecting Our Financial Condition and Results of Operations—Changes in accounting criteria and corrections” and Note 2(d) to our consolidated financial statements as of and for the year ended December 31, 2025.
iii
Non-IFRS Financial Measures
Certain parts of this annual report on Form 20-F contain non-IFRS financial measures, in particular constant currency. Our management uses this measure to evaluate the Group’s financial performance in making operational and strategic decisions for the Group. Therefore, we believe this measure is useful to investors and stakeholders.
Constant Currency
Net revenue variance in constant currency is determined by comparing adjusted current period figures, calculated using prior period monthly average exchange rates, to the prior period net revenue. The resulting percentage variance in constant currency is considered to be a non-IFRS-IASB financial measure. Net revenue variance in constant currency calculates net revenue variance without the impact of foreign exchange fluctuations. We believe that constant currency variance is an important measure of our operations because it neutralizes foreign exchange impact and illustrates the underlying change from one year to the next. We believe that this presentation provides a useful period-over-period comparison as changes due solely to exchange rate fluctuations are eliminated. Net revenue variance in constant currency, as defined and presented by us, may not be comparable to similar measures reported by other companies. Net revenue variance in constant currency has limitations, particularly because the currency effects that are eliminated constitute a significant element of our net revenue and could impact our performance significantly. We do not evaluate our results and performance without considering variances in constant currency on the one hand and changes prepared in accordance with IFRS-IASB on the other. We caution you to follow a similar approach by considering data regarding constant currency period-over-period revenue variance only in addition to, and not as a substitute for or superior to, other measures of financial performance prepared in accordance with IFRS-IASB. We present the fluctuation derived from IFRS-IASB net revenue next to the fluctuation derived from constant currency.
See below for a reconciliation of reported net revenues to net revenues in constant currency:
Year Ended December 31,
2025
2024
% var
2023
(in millions of euros)
Net Revenue
7,524
7,212
4.3
%
6,592
9.4
Variation due to exchange rate effects
59
Constant Currency Net Revenue
7,718
7.0
7,271
10.3
Market information (including market share, market position and industry data for our operating activities and those of our subsidiaries or of companies acquired by us) or other statements presented in this annual report on Form 20-F regarding our position (or that of companies acquired by us) relative to our competitors largely reflect the best estimates of our management. These estimates are based upon information obtained from customers, trade or business organizations and associations, other contacts within the industries in which we operate and, in some cases, upon published statistical data or information from independent third parties. Except as otherwise stated, our market share data, as well as our management’s assessment of our comparative competitive position, has been derived by comparing our sales figures for the relevant period to our management’s estimates of our competitors’ sales figures for such period, as well as upon published statistical data, information taken from filings with the Securities and Exchange Commission, or the SEC, and information from independent third parties, and, in particular, the reports published and the information made available by, among others, the Marketing Research Bureau, or the MRB. You should not rely on the market share and other market information presented herein as precise measures of market share or of other actual conditions.
iv
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This annual report contains statements that constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are typically identified by words such as “may,” “anticipate,” “believe,” “estimate,” “predict,” “expect,” “intend,” “forecast,” “will,” “would,” “should” or the negative of such terms or other variations on such terms or comparable or similar words or expressions.
These forward-looking statements reflect, as applicable, our management’s current beliefs, assumptions and expectations and are subject to a number of factors that may cause actual results to differ materially. These factors include, but are not limited to:
v
Please review a more detailed discussion of these and other risks that may impact our business set forth in this Form 20-F under “Item 3.D. Risk Factors.”
Forward-looking statements are not guarantees of future performance and involve risks, assumptions and uncertainties, including those listed above, and actual results may differ materially from those expressed or implied in the forward-looking statements.
All written and oral forward-looking statements concerning matters addressed in this annual report and attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this annual report. The forward-looking statements contained in this annual report speak only as of the date of this annual report. Except as required by law, we do not undertake to update any forward-looking statement to reflect events or circumstances after that date or to reflect the occurrence of unanticipated events.
vi
Not applicable.
Not Applicable.
Summary
Our company, our business and our securities are subject to a number of risks which are described more comprehensively elsewhere in this item D. We present below a summary of our key risk factors.
Risks Relating to Our Structure:
Risks Relating to the Company and Our Business:
2
3
Risks Relating to the Healthcare Industry:
4
Risks Relating to Our Shares and American Depositary Shares:
Risks Relating to Our Structure
Our substantial level of indebtedness could adversely affect our financial condition, restrict our ability to react to changes to our business, and prevent us from fulfilling our debt obligations.
We have a significant amount of indebtedness. As of December 31, 2025, our current and non-current financial liabilities were €9.6 billion, of which a substantial majority (€9.1 billion) was long-term debt.
Our high level of indebtedness could have significant adverse effects on our business, such as:
5
We expect to use cash flow from operations to pay our expenses and amounts due under our outstanding indebtedness. Our ability to make these payments depends on our future performance, which will be affected by financial, business, economic and other factors, many of which could be beyond our control. Our business may not generate sufficient cash flow from operations in the future and our anticipated growth in revenue and cash flow may not be realized, either or both of which could result in our being unable to repay indebtedness or to fund other liquidity needs. If we do not have enough liquidity, we may be required to refinance all or part of our then existing debt, sell assets or incur more debt. We may not be able to accomplish any of these alternatives on terms acceptable to us, or at all. In addition, the terms of existing or future debt agreements may restrict us from adopting any of these alternatives. The failure to generate sufficient cash flow or to achieve any of these alternatives could materially and adversely affect our business, results of operations and financial condition.
Despite our substantial indebtedness, we may still incur significantly more debt. This could exacerbate the risks associated with our substantial leverage.
We may be able to incur substantial additional indebtedness, including additional secured indebtedness, in the future. Our business is capital intensive, and we regularly seek additional capital. Although each of the indentures governing the 2021 Notes (as defined herein), the April 2024 Notes (as defined herein), December 2024 Notes (as defined herein) and the New Credit Facilities (as defined herein) contain restrictions on the incurrence of additional debt, these restrictions are subject to a number of qualifications and exceptions and, under certain circumstances, debt incurred in compliance with these restrictions, including secured debt, could be substantial. Incurring additional debt to current debt levels could exacerbate the leverage-related risks described above. For more information on our indebtedness, see Item 5 of this Part I, “Operating and Financial Review and Prospects—B. Liquidity and Capital Resources—Sources of Credit.”
To service our indebtedness and other obligations, we will require a significant amount of cash. Our ability to generate cash depends on many factors, some of which may be beyond our control.
Our ability to make payments on and to refinance our indebtedness and to fund working capital needs and planned capital expenditures will depend on our ability to generate cash in the future. A significant reduction in our operating cash flows resulting from changes in economic conditions, increased competition or other events beyond our control could increase the need for additional or alternative sources of liquidity and could have a material adverse effect on our business, financial condition, results of operations, prospects and our ability to service our debt and other obligations. If we are unable to service our indebtedness, we will be forced to adopt an alternative strategy that may include actions such as reducing capital expenditures, selling assets, restructuring or refinancing our indebtedness or seeking additional equity capital. We cannot assure you that any of these alternative strategies could be effected on satisfactory terms, if at all, or that they would yield sufficient funds to make required payments on our indebtedness.
In addition, our borrowings under the New Credit Facilities are at variable rates of interest and expose us to interest rate risk. If interest rates increase, our debt service obligations on the variable rate indebtedness would increase even though the amount borrowed remained the same, and our net income would decrease.
We cannot assure you that our business will generate sufficient cash flows from operations or that future borrowings will be available to us under the New Credit Facilities or otherwise in an amount sufficient to enable us to pay our indebtedness or to fund our other liquidity needs. We may need to refinance all or a portion of our indebtedness on or before the maturity of such indebtedness. We cannot assure you that we will be able to refinance any of our indebtedness, including the New Credit Facilities, the 2021 Notes, the April 2024 Notes and the December 2024 Notes, on commercially reasonable terms or at all. For more information on our indebtedness, see Item 5 of this Part I, “Operating and Financial Review and Prospects—B. Liquidity and Capital Resources—Sources of Credit.”
Covenants in our debt agreements restrict our business in many ways.
The agreements governing our indebtedness and other financial obligations applicable to us contain various covenants, with customary caveats, that limit our ability and/or our restricted subsidiaries’ ability to, among other things:
6
A breach of any of these covenants could result in a default under our debt agreements. Upon the occurrence of an event of default, the respective creditors could elect to declare all amounts outstanding under the debt agreements to be immediately due and payable and, in the case of the New Credit Facilities, December 2024 Notes, April 2024 Notes and 2021 Notes, terminate all commitments to extend further credit. If we were unable to repay those amounts, the respective creditors could proceed against the collateral granted to them to secure that indebtedness. We have pledged a significant portion of our assets as collateral under the New Credit Facilities, the April 2024 Notes and the December 2024 Notes. If the respective creditors under our existing indebtedness accelerate the repayment of borrowings, we may not have sufficient assets to repay our indebtedness.
Our ability to meet our financial obligations depends in part on our ability to receive dividends and other distributions from our subsidiaries.
Our principal assets are the equity interests that we hold in our operating subsidiaries. As a result, we are dependent on dividends and other distributions from our subsidiaries to generate the funds necessary to meet our financial obligations, including the payment of principal and interest on our outstanding debt. Our subsidiaries may not generate sufficient cash from operations to enable us to make principal and interest payments on our indebtedness or may have preferential dividends which are required to be paid prior to any dividends to us. For example, in the case of each of Biomat USA, Inc. (“Biomat USA”) and Biomat Newco Corp (“Biomat Newco”), our U.S.-based plasma collection subsidiaries, to the extent dividends are declared by their respective shareholders, the GIC Investor (as defined Item 4 of this Part I, “Information on the Company—A. History of and Development of the Company—Important Milestones”) would be entitled to receive preferred dividends. Such dividends are equal to $4,168,421.05 per share annually payable by each of Biomat USA (in respect of its ten preferential shares) and Biomat Newco (in respect of its nine preferential shares) and carry additional rights with them as well as including redemption rights and a liquidation preference of $52,105,263.16 per share. See Item 5 of this Part I, “Operating and Financial Review and Prospects—A. Operating Results—Factors Affecting Our Financial Condition and Results of Operations—Dispositions—The Biomat Transactions.”
In addition, any payment of dividends, distributions, loans or advances to us by our subsidiaries could be subject to restrictions on dividends or, in the case of foreign subsidiaries, restrictions on repatriation of earnings under applicable local law and monetary transfer restrictions in the jurisdictions in which our subsidiaries operate. Furthermore, payments to us by our subsidiaries will be contingent upon our subsidiaries’ earnings. Our subsidiaries are permitted under the terms of our indebtedness to incur additional indebtedness that may restrict payments from those subsidiaries to us. We cannot assure you that agreements governing current and future indebtedness of our subsidiaries will permit those subsidiaries to provide us with sufficient cash to fund payments on our indebtedness when due.
Our subsidiaries are legally distinct from us and, except for existing and future subsidiaries that guarantee certain indebtedness, have no obligation, contingent or otherwise, to pay amounts due on our debt or to make funds available to us for such payment.
7
We engage in transactions with related parties and such transactions present possible conflicts of interest that could have an adverse effect on us.
We purchase goods and services from, sell products to and otherwise engage in other transactions with related parties. These related party transactions create the possibility of conflicts of interest between us and our management, including that:
For more information on our related party transactions, see Item 7 of this Part I, “Major Shareholders and Related Party Transactions—B. Related Party Transactions” and Note 31 to our audited consolidated financial statements included in this annual report on Form 20-F.
We are a foreign private issuer under the rules and regulations of the Securities and Exchange Commission and, thus, are exempt from a number of rules under the Securities Exchange Act of 1934 and are permitted to file less information with the Securities and Exchange Commission than a company incorporated in the United States.
As a foreign private issuer under the Securities Exchange Act of 1934, as amended, or the Exchange Act, we are exempt from certain rules under the Exchange Act, including the proxy rules under Section 14 of the Exchange Act, which impose certain disclosure and procedural requirements for proxy solicitations. Moreover, we are not required to file periodic reports and financial statements with the Securities and Exchange Commission, or the SEC, as frequently or as promptly as U.S. companies with securities registered under the Exchange Act; we are not required to file financial statements prepared in accordance with United States’ generally accepted accounting principles; and we are not required to comply with SEC Regulation FD, which imposes certain restrictions on the selective disclosure of material non-public information. In addition, our officers, directors and principal shareholders currently are not subject to the reporting or short-swing profit recovery provisions of Section 16 of the Exchange Act or the rules under the Exchange Act with respect to their purchases and sales of our Class A shares or Class B shares. Accordingly, you may receive less information about us than you would receive about a company incorporated in the United States and may be afforded less protection under the U.S. federal securities laws than you would be afforded with respect to a company incorporated in the United States. If we lose our status as a foreign private issuer at some future time, we will no longer be exempt from such rules and, among other things, will be required to file periodic reports and financial statements as if we were a company incorporated in the United States. The costs incurred in fulfilling these additional regulatory requirements could be substantial.
Additionally, pursuant to The NASDAQ Stock Market LLC (“NASDAQ”) listing rules (the “NASDAQ Listing Rules”), as a foreign private issuer we may elect to follow our home country practice in lieu of the corporate governance requirements of the NASDAQ Listing Rule 5600 Series, with the exception of those rules that are required to be followed pursuant to the provisions of NASDAQ Listing Rule 5615(a)(3). We have elected to follow Spanish practices in lieu of the requirements of the NASDAQ Listing Rule 5600 Series to the extent permitted under NASDAQ Listing Rule 5615(a)(3). See Item 16.G of Part II, “Corporate Governance.”
8
Military conflicts around the world, and the global response thereto, may adversely affect our business and results of operations.
The occurrence of unforeseen or catastrophic events, including geopolitical and other economic or political conditions or events such as the military conflict between Russia and Ukraine since 2022, the ongoing conflict in Gaza following the terrorist attacks that occurred in Israel in October 2023, and the broader regional conflict involving Iran, Israel and the United States, depending on their scale and duration, may adversely affect national, regional and global economies and could disrupt our operations. For example, in response to these military conflicts, significant sanctions and export controls have been imposed against certain countries, individuals and entities. These conflicts have also resulted in significant volatility and disruptions to the global markets.
It is not possible to predict the long-term implications of these conflicts, which could include but are not limited to new trade restrictions, tariffs, or other retaliatory measures contingent upon ongoing developments and diverging foreign policy positions among governments, uncertainty about economic and political stability, increases in inflation rates, further increases in energy prices, supply chain challenges and adverse effects on currency exchange rates and financial markets.
In addition, these or any other future conflicts have led or could lead to increased threats of cyberattacks, which can pose risks to the security of our IT systems, our network and our service offerings, as well as the confidentiality, availability and integrity of our data.
Up to the present date, the conflicts in Ukraine, Gaza and Iran have not significantly affected our business operations, but we cannot be certain that such conflicts will not affect existing and potential customers and have an adverse impact on our operations in the future.
The ability to serve process and enforce civil liabilities under U.S. securities laws may be limited.
We are a company organized under the laws of Spain, and many of our subsidiaries are also incorporated outside of the United States. A substantial portion of our assets and the assets of our subsidiaries are located outside of the United States. In addition, nearly all of our directors and officers and certain of our subsidiaries’ officers and directors are nationals or residents of countries other than the United States, and all or a substantial portion of such persons’ assets are located outside the United States. As a result, it may be difficult for investors to effect service of process within the United States upon us or certain of our subsidiaries or their directors or officers with respect to matters arising under the Securities Act of 1933 (the “Securities Act”) or to enforce against them judgments of courts of the United States predicated upon civil liability under the Securities Act. It may also be difficult to recover fully in the United States on any judgment rendered against such persons or against us or certain of our subsidiaries.
In addition, there is doubt as to the enforceability in Spain of original actions, or of actions for enforcement of judgments of U.S. courts of liabilities, predicated solely upon the securities laws of the United States. If a judgment was obtained outside Spain and efforts were made to enforce the judgment in Spain, there is some doubt that Spanish courts would agree to recognize and enforce a foreign judgment. Accordingly, even if you obtain a favorable judgment in a U.S. court, you may be required to re-litigate your claim in Spain.
9
We are a multinational business that operates in numerous tax jurisdictions.
We are subject to evolving and complex tax laws in the jurisdictions in which we operate, and routinely obtain advice on tax-related matters. Significant judgment is required in determining our tax liabilities, and our tax returns are periodically examined by various tax authorities. We regularly assess the likelihood of outcomes resulting from these examinations to determine the adequacy of our accrual for tax contingencies; however, due to the complexity of tax matters, the ultimate resolution of any tax matters may result in payments greater or less than the amounts accrued. In addition, we may be affected by changes in tax laws, including tax rate changes, new tax laws, and revised tax law interpretations in domestic and foreign jurisdictions and between jurisdictions, including by the E.U., which could have a material and adverse effect on our tax expense and/or tax balances, and changes in tax policies could have a material and adverse impact our business. Furthermore, the integrated nature of our worldwide operations can produce conflicting claims from revenue authorities in different countries as to the profits to be taxed in the individual countries, including potential disputes relating to the prices our subsidiaries charge one another for intercompany transactions, known as transfer pricing. Additionally, existing or future executive orders or other changes in laws regarding tariffs, including by the U.S. executive administration and Congress, the European Union and/or China, could adversely affect our business, financial position and results of operations. The impact of any changes in laws regarding tariffs on our business, if any, will depend on the specific restrictions imposed on trade, including the effective date and duration of such tariffs, jurisdictions covered in such tariffs, amounts of such tariffs, and potential retaliatory tariffs imposed by other jurisdictions. The occurrence of any of these risks could have a material adverse effect on our business, financial position and results of operations.
In particular, the Organization for Economic Co-operation and Development (“OECD”) introduced a new inclusive framework on Base Erosion and Profit Shifting that contains a two-pillar solution to address the tax challenges arising from the digitalization of the economy. These changes are now being progressively implemented by tax authorities around the world and represent a fundamental change to the international tax framework. Pillar One provides for a new nexus standard/taxing right that allocates a portion of intangible/residual profits directly to market jurisdictions but only for the largest and most profitable companies. Pillar Two provides for a global minimum level of taxation (15%) that establishes a floor for tax competition amongst jurisdictions. Since the introduction of the OECD Inclusive Framework, over 140 countries have endorsed the framework and E.U. member states formally adopted the E.U.’s Pillar Two Directive. However, the U.S. voiced concerns regarding the application of the global minimum tax and stated that it may impose retaliatory taxes or take other retaliatory actions against companies from jurisdictions (including in the E.U.) that applied or would apply the global minimum tax. Nevertheless, the U.S. Treasury Department has since stated that it reached an agreement with the G7 regarding the treatment of U.S.-headquartered multinational groups in connection with Pillar Two. On January 5, 2026, the OECD/G20 Inclusive Framework announced a “side-by-side” package; however, the implementation and potential effects of these developments remain uncertain.
As of the date of this annual report, certain E.U. member states have begun to transpose the directive into law, but enforcement dates vary. A number of E.U. member states have begun to implement the rules, subject to transitional rules and permitted deferrals. While we do not anticipate that Pillar Two will have a material impact on our tax provision or effective tax rate, it is possible that Pillar Two may result in top-up taxes in some jurisdictions in which we operate and we continue to monitor evolving tax legislation. Depending on the final rules, we may face requirements for increased tax and accounting disclosures, as well as additional compliance and reporting obligations. For more information, see Note 28 to the audited consolidated financial statements included in this annual report.
The unforeseen results of potential trade disputes and reciprocal tariffs around the world, including the United States, the European Union and/or China may cause an impact on our business.
Our operations expose us to the risk that increased trade protectionism from the United States, the European Union, China or other nations adversely affect our business. Governments may turn to trade barriers to protect or revive their domestic industries in the face of foreign imports. Restrictions on imports, including in the form of tariffs, could have a major impact on global trade and, indirectly, demand for our products. Trade protectionism in the markets we serve may cause an increase in the cost of exported goods, the length of time required to deliver goods and the risks associated with exporting goods and, as a result, a decline in the volume of exported goods and demand for imported products, including our plasma-derived therapies. In addition to tariffs, governments have increasingly implemented export controls, investment restrictions, anti-subsidy investigations, supply chain localization requirements and other trade-related measures that may affect cross-border flows of goods, capital and technology. Due to the interconnected nature of the global supply chain for many products, these policies could impact imports and exports from countries not directly imposing or subject to tariffs or other measures.
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Tensions over trade and other matters remain high between the U.S. and other countries, including the members of the E.U. and China. The current U.S. administration, led by President Trump, instituted widespread tariffs on a wide variety of goods, including from the European Union and China, which led, and could continue to lead, to retaliatory tariffs from other countries including China and the E.U. The continued use of tariffs and other trade policy tools by the United States and other governments has created significant uncertainty about the future relationship between the United States and China, the European Union, Canada, Mexico and other exporting countries, including with respect to trade policies, treaties, government regulations and tariffs, and has led to concerns regarding the potential for an extended trade war. Protectionist developments, or the perception they may occur, may have a material adverse effect on global economic conditions, and may significantly reduce global trade and, in particular, trade between the United States and other countries, including China and countries in the European Union, which could adversely affect our business, results of operations, and financial condition. Any new or increased trade barriers or restrictions on trade, including as a result of tariffs imposed by the United States or other countries, could have an adverse impact on our business, operating results and financial condition.
Changes in immigration laws in the countries in which we operate, including Canada and the United States, could affect our ability to send employees with specified expertise in manufacturing and IT into foreign regions for purposes of building or upgrading certain infrastructure.
We are highly dependent upon skilled personnel in key parts of our organization, and we invest heavily in recruiting, training and retaining qualified individuals. The success of our business is dependent on our ability to attract and retain talented and experienced professionals, and the ability to mobilize them around the world to meet our growth needs, including the construction of new facilities and upgrades of existing infrastructure throughout the world.
Laws, regulations and customs, including legislation and customary practice in the United States and Canada, our main markets, may restrict our ability to attract, motivate and retain the required level of qualified personnel. Some countries and non-governmental organizations have recently expressed concerns about a perceived connection between offshore outsourcing and the loss of domestic jobs. It is difficult to predict the political and economic events that could affect immigration laws, or the restrictive impact they could have on obtaining or renewing work visas for our manufacturing and technology professionals. Immigration laws in the countries we operate in are subject to legislative changes, as well as to variations in the standards of application and enforcement due to political forces and economic conditions. Changes in immigration laws to restrict outsourcing of services internationally by domestic corporations, limit the availability of certain work visas or increase visa fees in the key markets in which we operate may impact our ability to staff projects in a timely manner and negatively affect our profitability.
In addition to calls for changes to U.S. immigration laws regarding the admission of highly skilled temporary and permanent workers, legislation restricting outsourcing may be enacted at the federal and/or state level in the United States. Since a large part of our business centers around the United States, changes to U.S. immigration laws could make it more difficult to obtain the required nonimmigrant work authorizations for our employees that allow us to compete for and provide timely and cost-effective services to our clients in the United States, which in turn could adversely affect our revenues and operating profitability. Furthermore, our international expansion and our business in general may be materially adversely affected if legislative or administrative changes to immigration or visa laws and regulations impair our hiring processes or projects involving personnel who are not citizens of the country where their work is to be performed. If we are not able to add and retain employees effectively, our ability to achieve our strategic objectives will be adversely affected, and our business and growth prospects will be harmed.
Risks Relating to the Company and Our Business
Our manufacturing processes are complex and involve biological intermediates that may be susceptible to contamination and variations in yield. Plasma and plasma derivative products are fragile, and improper handling of the plasma or plasma derivative products could adversely affect our operations.
Plasma is a raw material that is susceptible to damage and contamination and may contain human pathogens, any of which would render the plasma unsuitable for further manufacturing. Almost immediately after its collection from a donor, plasma is stored and transported at temperatures that are at or below -20 degrees Celsius (-4 degrees Fahrenheit). For instance, contamination or improper storage of plasma by us or third-party suppliers may require us to destroy some of our raw material. If unsuitable plasma is not identified and discarded prior to its release to our manufacturing processes, it may be necessary to discard intermediate or finished product made from that plasma or to recall any finished product released to the market, resulting in a charge to cost of goods sold.
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Our failure, or the failure of third parties that supply, ship or distribute our plasma and plasma derivative products, to properly care for our plasma or plasma derivative products may require us to destroy some raw materials or products. If the volume of plasma or plasma derivative products damaged by such failures were to be significant, the loss of that plasma or those plasma derivative products could have a material adverse effect on our financial condition and results of operations.
The manufacture of our plasma products is an extremely complex process of fractionation (separating the plasma into component proteins), purification, filling and finishing. Our products can become non-releasable or otherwise fail to meet our specifications through a failure of one or more of our product testing, manufacturing, process controls and quality assurance processes. We may detect instances in which an unreleased product was produced without adherence to our manufacturing procedures or plasma used in our production process was not collected or stored in a compliant manner consistent with Current Good Manufacturing Practice (“cGMP”) regulations enforced by the U.S. Food and Drug Administration (“FDA”) and analogous regulatory authorities of other countries, or other similar regulations, which would likely result in our determination that the impacted products should not be released and therefore should be destroyed.
Once we have manufactured our plasma-derived products, they must be handled carefully and kept at appropriate temperatures. Our failure, or the failure of third parties that supply, ship or distribute our products, to properly care for our plasma-derived products may require that such products be destroyed.
While we expect to write off small amounts of work in process inventories in the ordinary course of business due to the complex nature of plasma, our processes and our products, unanticipated events may lead to write-offs and other costs materially in excess of our expectations. Such write-offs and other costs could cause material fluctuations in our profitability. Furthermore, contamination of our products could cause investors, consumers or other third parties with whom we conduct business to lose confidence in the reliability of our manufacturing procedures, which could adversely affect our sales and profits. In addition, faulty or contaminated products that are unknowingly distributed could result in patient harm, threaten the reputation of our products and expose us to product liability damages and claims.
Due to the nature of plasma, there will be variations in the biologic properties of the plasma we collect or purchase for fractionation that may result in fluctuations in the obtainable yield of desired fractions, even if cGMP regulations are followed. Lower yields may limit production of our plasma-derived products due to capacity constraints. If such batches of plasma with lower yields impact production for extended periods, it may reduce the total volume of product that we could market and increase our cost of goods sold, thereby reducing our profitability.
Our manufacture of intermediate immunoassay antigens and antibodies to screen human donated blood and blood products is also a complex biologic process, subject to substantial production risks. These processes typically involve an upstream or fermentation process and a downstream or purification process. Since in the upstream process we deal with living cells, we may face a contamination by undesired cells which would eventually translate into a low yield. Yields in general can also be greatly affected by the different nutrients compositions added to the reactors in this fermentation step. Likewise, during the purification step, we can face low yields due to poor resins composition, equipment failure or procedural mistakes.
Once our products are approved and marketed, we must continually monitor them for signs that their use may result in serious and unexpected side effects, which could jeopardize our reputation and our ability to continue marketing our products. We may also be required to conduct post-approval clinical trials as a condition to licensing a product.
As for all pharmaceutical products, the use of our products sometimes produces undesirable side effects or adverse reactions or events (collectively, “adverse events”). For the most part, these adverse events are known, are expected to occur at some frequency and are described in the products’ labeling. Known adverse events of a number of our products include allergic or anaphylactic reactions including shock and the transmission of infective agents. Further, the use of certain products sometimes produces additional adverse events, which are detailed below.
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In addition, the use of our products may be associated with serious and unexpected adverse events, or with less serious reactions at a greater than expected frequency. This may be especially true when our products are used in critically ill patient populations. When these unexpected events are reported to us, we must undertake a thorough investigation to determine causality and implications for product safety. These events must also be specifically reported to the applicable regulatory authorities. If our evaluation concludes, or regulatory authorities perceive, that there is an unreasonable risk associated with the product, we would be obligated to withdraw the impacted lot(s) of that product. Furthermore, an unexpected adverse event caused by a new product may be recognized only after extensive use of the product, which could expose us to product liability risks, enforcement action by regulatory authorities and damage to our reputation.
Once we produce a product, physicians are responsible for prescribing and administering the product as we have directed and for the indications described on the labeling. It is not, however, unusual for physicians to prescribe our products for unapproved, or off-label, uses or in a manner that is inconsistent with our directions or the labeling. To the extent such off-label uses and departures from our administration directions become pervasive and produce results such as reduced efficacy or other adverse effects, the reputation of our products in the marketplace may suffer.
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Our ability to continue manufacturing and distributing our products depends on our continued adherence to cGMP regulations at our facilities.
The manufacturing processes for our products are governed by detailed written procedures and governmental regulations that set forth cGMP requirements for blood, blood products and other products. Our quality operations unit monitors compliance with these procedures and regulations, and the conformance of materials, manufacturing intermediates and final products to their specifications. Failure to adhere to established procedures or regulations, or to meet a specification, could require that a product or material be rejected and destroyed.
Our adherence to cGMP regulations and the effectiveness of our quality systems are periodically assessed through inspections of our facilities by the FDA, and analogous regulatory authorities of other countries. If deficiencies are noted during an inspection, we must take action to correct those deficiencies and to demonstrate to the regulatory authorities that our corrections have been effective. If serious deficiencies are noted or if we are unable to prevent recurrences, we may have to recall product or suspend operations until appropriate measures can be implemented. We are also required to report certain deviations from procedures to the FDA and analogous regulatory authorities of other countries, and even if we determine that the deviations were not material, such regulatory authorities could require us to take similar measures. Since cGMP reflects ever-evolving standards, we regularly need to update our manufacturing processes and procedures to comply with cGMP. These changes may cause us to incur costs without improving our profitability or the safety of our products. For example, more sensitive testing assays (if and when they become available) may be required or existing procedures or processes may require revalidation, all of which may be costly and time consuming and could delay or prevent the manufacturing of a product or launch of a new product. Further, changes in FDA policy, priorities, or resource allocation may affect our ongoing operations.
Changes in manufacturing processes, including a change in the location where the product is manufactured or a change of a third-party manufacturer, may require prior review and approval or revalidation by the FDA or other regulatory authorities of the manufacturing processes and procedures in accordance with cGMP regulations.
To validate our manufacturing processes and procedures following completion of our upgraded facilities, we must demonstrate that the processes and procedures at the upgraded facilities are comparable to those currently in place at our other facilities. To provide such a comparative analysis, both the existing processes and the processes that we expect to be implemented at our upgraded facilities must comply with the regulatory standards prevailing at the time that our expected upgrade is completed. In addition, regulatory requirements, including cGMP regulations, continually evolve. Failure to adjust our operations to conform to new or updated standards as established and interpreted by applicable regulatory authorities would create a compliance risk that could impair our ability to sustain normal operations.
Regulatory authorities, including the FDA and the European Medicines Office (“EMA”), routinely inspect our facilities to assess ongoing compliance with cGMP. If the FDA, the EMA or other regulatory authorities find our facilities to be out of compliance, our ongoing operations or plans to expand would be adversely affected.
A significant disruption in our supply of plasma, including as a result of macroeconomic conditions, pandemics or changes in immigration policies and enforcement could have a material adverse effect on our business and our growth plans.
The majority of our revenue depends on our access to U.S. source plasma (obtained through plasmapheresis), the principal raw material for our plasma derivative products. Our ability to increase revenue depends substantially on increased access to and availability of plasma. If we are unable to obtain sufficient quantities of source plasma, we may be unable to find an alternative cost-effective source of plasma and we would be limited in our ability to maintain current manufacturing levels of plasma derivative products. As a result, we could experience a substantial decrease in net revenue or profit margins, a loss of customers, a negative effect on our reputation as a reliable supplier of plasma derivative products or a substantial delay in our production growth plans.
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Our current business plan envisages an increase in the production of plasma derivative products, which depends on our ability to maintain and/or increase plasma collections or improve product yield. The ability to maintain and/or increase plasma collections may be limited, our supply of plasma could be disrupted or the cost of plasma could increase substantially, as a result of numerous factors, including:
Disruption of the operations of our plasma collection centers would cause us to become supply-constrained and our financial performance would suffer.
In order for plasma to be used in the manufacturing of our products, the individual centers at which the plasma is collected must be licensed and approved by the regulatory authorities, such as the FDA and the EMA, of those countries in which we sell our products. When a new plasma collection center is opened, it must be inspected on an ongoing basis after its approval by the FDA, the EMA and other applicable regulatory authorities for compliance with cGMP and other regulatory requirements, and these regulatory requirements are subject to change. While we believe that our centers timely comply with evolving requirements, the compliance efforts necessary for evolving requirements may increase our costs. An unsatisfactory inspection could prevent a new center from being approved for operation or risk the suspension or revocation of an existing approval.
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In order for a plasma collection center to maintain its governmental approval to operate, its operations must continue to conform to cGMP and other regulatory requirements. In the event that we determine a plasma collection center did not comply with cGMP and other regulatory requirements in collecting plasma, we may be unable to use and may ultimately destroy plasma collected from that center, which would be recorded as a charge to cost of goods. Additionally, if noncompliance in the plasma collection process is identified after the impacted plasma has been pooled with compliant plasma from other sources, entire plasma pools, in-process intermediate materials and final products could be impacted. Consequently, we could experience significant inventory impairment provisions and write-offs.
We plan to continue to obtain our supplies of plasma for use in our manufacturing processes through collections at our plasma collection centers and through selective acquisitions or remodeling and relocations of existing centers. This strategy is dependent upon our ability to successfully integrate new centers, to obtain FDA and other necessary approvals for any centers not yet approved by the FDA or other regulatory authorities, to maintain a cGMP compliant environment in all centers and to attract donors to our centers.
Our ability to increase and improve the efficiency of production at our plasma collection centers may be affected by: (i) changes in the economic environment and population in selected regions where we operate plasma collection centers; (ii) the entry of competitive centers into regions where we operate; (iii) our misjudging the demographic potential of individual regions where we expect to increase production and attract new donors; (iv) unexpected facility related challenges; (v) unexpected management challenges at select plasma collection centers; (vi) adverse events at our centers; or (vii) unforeseen governmental changes to policies limiting the donor population or imposing regulations that make plasma donations onerous and restrictive.
A significant portion of our net revenue has historically been derived from sales of our immunoglobulin products and we expect that they will continue to comprise a significant portion of our sales. Any adverse market event with respect to these products could have a material adverse effect on us.
We have historically derived a significant portion of our net revenue from our immunoglobulin products. In 2025 and 2024, our immunoglobulin products accounted for approximately 54.3% and 50.8% of our net revenue, respectively. If any of these products were to lose significant sales or were substantially or completely displaced in the market, we would lose a significant and material source of our net revenue. Similarly, if either Flebogamma, Gamunex-C/Gamunex, Xembify or Prolastin were to become the subject of litigation or an adverse governmental ruling requiring us to cease sales of it, our business could be adversely affected. Although we do not currently anticipate any significant decrease in the sales of any of these products, a significant decrease could result from plasma procurement and manufacturing issues resulting in lower product availability for sales and changing market conditions.
We face significant competition, including from companies with greater financial resources.
We face significant competition. Each of Takeda, CSL Behring, Kedrion Biopharma, Octapharma Plasma and Bio Products Laboratory Ltd. now has a 10% liquid IVIG product in the United States. Both Octapharma and Bio Products Laboratory also have 5% liquid IVIG products. GC Biopharma introduced its 10% IVIG product, AlygloTM, to the U.S. market in 2024 and Argenx obtained FDA approval in 2021 for VYVGART (IV) and in 2024 for VYVGART Hytrulo (subcutaneous), a non-plasma derived product that would treat patients with chronic inflammatory demyelinating polyneuropathy (“CIDP”). Such products are direct competitors to some of our main products, Flebogamma, Gamunex-C/Gamunex or Xembify. As competition has increased, some of our competitors have discounted the price of immunoglobulin products as many customers have become increasingly price sensitive. If customers demand lower-priced products, we may lose sales or be forced to lower our prices.
In the therapeutic area of pulmonology, specifically alpha-1-antitrypsin augmentation therapy (“AAT”), we face competition from other companies such as Mereo Biopharma and AATec Medical in researching and developing novel oral and inhaled recombinant AAT therapies, respectively. In addition, gene therapies focusing on alpha-1 are potentially in development. We expect increased competition will come from Sanofi due to its acquisition from Inhibrx of all the assets and liabilities associated with INBRX-101, an optimized recombinant AAT augmentation therapy. In the area of alpha1-proteinase inhibitor deficiency, CSL’s Respreeza/Zemaira and Takeda’s Aralast (lyo)/Glassia (liquid) are competing with our Prolastin product. Our current and future competitors may increase their sales, lower their prices, change their distribution model or improve their products, causing harm to our product sales and market share. Also, if the attrition rate of our A1PI patient base accelerates faster than we have forecasted, we would have fewer patients and lower sales volume.
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Our competitors may also develop other new treatments, such as small molecules, recombinant products, inhaled products, gene therapies, or other novel therapies for indications for which our products are currently used. Recombinant Factor VIII and Factor IX products, which are currently available and widely used in the United States and Europe, compete with our plasma-derived product in the treatment of hemophilia A and B and are perceived by many to have lower risks of disease transmission. Additional recombinant products and new small molecules, some with extended half-lives, compete with and reduce the demand for our products. Genetech’s Hemlibra, a non-plasma product to control bleeding in patients with hemophilia A, is another competitor in the hemophilia market. The use of Hemlibra is a significant competitive risk for the use of plasma derived and recombinant Factor VIII. Additionally, numerous novel gene therapies have been approved and more are under development for the treatment of hemophilia which may further compete with our existing plasma derived therapies.
Furthermore, while we are investigating additional indications for the use of albumin, these new possibilities are countered by the fact that there are alternatives from competitors for albumin use in the main application we apply it, as a plasma volume expander. In addition to competition from other plasma-derived product manufacturers, there are several companies developing recombinant human albumin, primarily focusing on China, the largest albumin market, and also planning geographic expansion into certain countries in the Asia-Pacific region and the Middle East. Recombinant albumin products could primarily affect markets such as China and India in the short term due to their potentially unlimited supply, lower prices and shorter manufacturing times compared to plasma-derived albumin. Currently, there are five companies developing recombinant human albumin, three based in China and two based in India.
Healthgen, a Chinese company, developed the first recombinant human albumin product which was approved in July 2025 and is derived from rice. This product received approval only for the treatment of liver Cirrhosis with hypoalbuminemia (less than or equal to 30 g/L), which is not a harmonized indication comparable to those approved for plasma derived albumin products. Anrate and Proetgen are considered among the more promising recombinant albumin developers, as their products are based on yeast. Anrate is expected to submit a new drug application in the second or third quarter of 2026. Both Healthgen and Anrate have completed Phase III clinical trials and reported efficacy and safety; however, long term safety data for recombinant albumin products still needs to be proven. Recombinant technology may also provide manufacturing advantages, including shorter production timelines compared to the several months typically required for plasma derived albumin production, particularly for yeast based platforms. The Indian recombinant albumin developers are currently expected to obtain regulatory approvals beyond 2027.
We are only one of a number of companies that produce an alpha-1 anti-trypsin for the treatment of patients with hereditary emphysema and our competitors continually develop new products including inhaled, gene therapy, recombinant or other new various methods of administration for this therapy. Additionally, new treatments such as gene therapy, inhaled and recombinant products are in development by other companies and, regardless of the uncertainties surrounding the potential safety and efficacy of such new treatments, they increase our level of competition.
The introduction of products approved for alternative routes of administration, including subcutaneous, may also adversely affect sales of our products. For example, CSL Behring and Takeda introduced preparations of human immunoglobin at a 20% concentration for the treatment of people who need antibody replacement and Takeda has an immune globulin with a recombinant human hyaluronidase indicated for the treatment of primary immunodeficiency (“Pl”) in adults. Although we have FDA approval for similar concentrations and routes of administration, the level of competition remains significant and trending up as other players continue developing their operations in this expanding area of therapy.
Other companies are developing different therapies for the treatment of autoimmune diseases and other disorders that are currently treated with our immunoglobulins. If an increased use of alternative products for Factor VIII, Factor IX, albumin, alpha-1 or immunoglobulins makes it uneconomical to produce our plasma-derived products, or if further technological advances improve these products or create other competitive alternatives to our plasma derivative products, our financial condition and results of operations could be materially adversely affected. We expect in the future to face greater competition from biosimilar products which could further adversely affect our financial performance.
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We do not currently sell therapeutic recombinant products. We have additional versions of A1PI in our pipeline, but we cannot be certain that any of these products will be approved or sold in the future. Additionally, we are developing other potential innovations in the area of immunoglobulins. For example, our subsidiary GigaGen utilizes a proprietary, single-cell platform to discover and develop recombinant polyclonal and monoclonal antibody therapies to treat life-threatening diseases, with a number of initiatives currently under pre-clinical and clinical development. However, we cannot be certain that we will succeed in developing these products for licensed commercial use. As a result, our product offerings may remain plasma-derived in the near term, even if our competitors offer competing recombinant products.
In addition, some of our competitors have significantly greater financial resources than us. As a result, they may be able to devote more funds to research and development and new production technologies, as well as to the promotion of their products and business. These competitors may also be able to sustain for longer periods a deliberate substantial reduction in the price of their products or services. The development by a competitor of a similar or superior product or increased pricing competition may result in a reduction in our net revenue or a decrease in our profit margins.
Technological changes in the production of our products may require substantial investments in innovation, digital transformation and new technologies, which could render our production process uneconomical and diminish our competitiveness in the industries in which we operate.
The production of our plasma derivative, diagnostic and bio supplies products is characterized by factors such as rapid technological change, medical advances, changing consumer requirements, short device lifecycles, changing regulatory requirements and evolving industry standards. Technological advances have accelerated changes in recent years and future technological developments and medical advances could render our production processes uneconomical. Our success may depend on our ability to enhance our current technology, including through the use of artificial intelligence tools, and develop or acquire new technologies to keep pace with technological developments and evolving industry standards, while responding to changes in customer needs. Such innovation efforts may require us to invest substantial amounts of capital to upgrade our facilities and develop our products at competitive prices.
Additional investments in new technologies, processes, and business models expose us to certain risks and challenges, such as inconsistencies with the company’s strategy, talent resources and geographical constraints, financial resource limitations, and adaptation to external factors out of our control. These risks and challenges have the potential to undermine achieving the full benefits of digital transformation and diminish the company’s competitiveness within the industry in which we operate.
We utilize artificial intelligence, which could expose us to liability or adversely affect our business.
We have built and integrated, and may in the future build, integrate and utilize, artificial intelligence (“AI”) tools in connection with our business, products and services, including AI designed to reduce energy consumption in cooling plants and to enhance the production performance of IVIG. However, there are significant risks involved in utilizing AI and no assurance can be provided that our use will enhance our products or services or produce the intended results. For example, AI algorithms may be flawed, insufficient, of poor quality, reflect unwanted forms of bias or contain other errors or inadequacies, any of which may not be easily detectable, which could impair the acceptance of AI solutions, including those incorporated into our products and services. If the AI solutions that we create or use are deficient, inaccurate, controversial, highly regulated, or impermissible, we could incur operational inefficiencies, competitive harm, legal liability, brand or reputational harm, or other adverse impacts on our business and financial results. Further, there can be no assurance that our use of AI will be successful in increasing our operational efficiencies or otherwise result in our intended outcomes.
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The use of certain artificial intelligence technology can give rise to intellectual property risks, including compromises to proprietary intellectual property and intellectual property infringement. Additionally, we expect to see increasing government, international, and supranational regulation related to artificial intelligence use and ethics, which may also significantly increase the burden and cost of research, development and compliance in this area. For example, the European Union’s Artificial Intelligence Act enacted in 2024 (the “AI Act”) — the world’s first comprehensive AI law — imposes significant obligations on providers and deployers of high-risk artificial intelligence systems and encourages providers and deployers of artificial intelligence systems to account for ethical principles in their development and use of these systems. If we develop or use AI systems that are governed by the AI Act, it may necessitate ensuring higher standards of data quality, transparency, and human oversight, as well as adhering to specific and potentially burdensome and costly ethical, accountability, and administrative requirements. The rapid evolution of artificial intelligence will require the application of significant resources to design, develop, test and maintain our products and services to help ensure that artificial intelligence is implemented in accordance with applicable law and regulation and in a socially responsible manner and to minimize any real or perceived unintended harmful impacts. Our vendors may in turn incorporate artificial intelligence tools into their own offerings, and the providers of these artificial intelligence tools may not meet existing or rapidly evolving regulatory or industry standards, including with respect to privacy and data security. Further, bad actors around the world use increasingly sophisticated methods, including the use of artificial intelligence, to conduct cyberattacks and to engage in illegal activities involving the theft and misuse of personal information, confidential information and intellectual property. Any of these effects could damage our reputation, result in the loss of valuable property and information, cause us to breach applicable laws and regulations, and adversely impact our business.
The discovery of new pathogens could slow our growth and adversely affect profit margins.
The possible appearance of new pathogens could trigger the need for changes in our existing inactivation and production methods, including the administration of new detection tests. Such a development could result in delays in production until the new methods are in place, as well as increased costs that may not be readily passed on to our customers.
Product liability claims or product recalls and/or voluntary withdrawals involving our products or products we distribute could have a material adverse effect on our business.
Our business exposes us to the risk of product liability claims. We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and an even greater risk when we commercially sell any products. If we cannot successfully defend ourselves against claims that our product candidates or products caused injuries, we could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in any or all of the following:
Like many plasma fractionators, we have been, and may in the future be, involved in product liability or related claims relating to our products, including claims alleging the transmission of disease through the use of such products. Plasma is a biological matter that is known to be capable of transmitting viruses and pathogens, whether known or unknown. Therefore, our plasma and plasma derivative products, if donors are not properly screened or if the plasma is not properly collected, tested, inactivated, processed, stored and transported, could cause serious disease and possibly death to the patient. Any transmission of disease through the use of one of our products or third-party products sold by us could result in claims by persons allegedly infected by such products.
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Our potential product liability also extends to our Diagnostic business unit and Healthcare Solutions (as defined herein) products. In addition, we sell and distribute third-party products, and the laws of the jurisdictions where we sell or distribute such products could also expose us to product liability claims for those products. Furthermore, the presence of a defect in a product could require us to carry out a recall of such product.
A product liability claim, or a product recall and/or a voluntary withdrawal of products could result in substantial financial losses, negative reputational repercussions and an inability to retain customers. Although we have a program of insurance policies designed to protect us and our subsidiaries from product liability claims, and we self-insure a portion of this risk, claims made against our insurance policies could exceed our limits of coverage. We intend to expand our insurance coverage as our sales grow. However, as product liability insurance is expensive and can be difficult to obtain, a product liability claim could decrease our access to product liability insurance on acceptable terms. In turn, we may not be able to maintain insurance coverage at a reasonable cost and may not be able to obtain insurance coverage that will be adequate to satisfy any liability that may arise. Although we have not experienced a material liability claim, we cannot assure you that we will not experience one in the future.
Our ability to continue to produce safe and effective plasma derivative products depends on a plasma supply free of transmittable diseases.
Despite overlapping safeguards, including the screening of donors and other steps to remove or inactivate viruses and other infectious disease-causing agents, the risk of transmissible disease through plasma-derived products cannot be entirely eliminated. If a new infectious disease was to emerge in the human population in the future, the regulatory and public health authorities could impose precautions to limit the transmission of the disease that would impair our ability to procure plasma, manufacture our products or both. Such precautionary measures could be taken before there is conclusive medical or scientific evidence that a disease poses a risk for plasma-derived products.
In recent years, new testing and viral inactivation methods have been developed that more effectively detect and inactivate infectious viruses in collected plasma. There can be no assurance, however, that such new testing and inactivation methods will adequately screen for, and inactivate, infectious agents in the plasma used in the production of our products.
Ineffective IT governance, as well as a lack of related compliance, operational safeguards, and implementation of appropriate cybersecurity measures poses significant risks in today’s data-driven world, including data breaches, regulatory non-compliance, operational inefficiencies, financial losses and hindered innovation.
We are highly dependent on IT processes, which may make ineffective governance a material risk. Ineffective IT practices can result in data breaches, which can be impactful on us by way of breaching contractual requirements, violating certain applicable laws, and exposing us to financial and reputational damage. In addition, ineffective IT governance can result in us failing to comply with certain regulatory requirements in this area that can lead to legal penalties and loss of trust among stakeholders. Lastly, we can be exposed to certain operational inefficiencies by not having strong IT governance practices leading to increased costs and reduced productivity, disruptions in business processes and the need for remediation efforts. See Item 16K of Part II, “Cybersecurity,” for additional details.
In addition, in 2025 we began transitioning our main enterprise resource planning system to S/4HANA, a SAP platform, to streamline our operations. We have heavily invested in this transition, and any disruptions, data loss or systems failures resulting from the transition could negatively impact or business and financial results.
Our future success depends on our ability to retain members of our senior management and to attract, retain and motivate qualified personnel.
We are highly dependent on the principal members of our executive and scientific teams. The loss of the services of any of these persons might impede the achievement of our research, development, operational and commercialization objectives. In particular, we believe the loss of any member of our senior management team could significantly and negatively impact our business. For details regarding the members of senior management, see Item 6 of this Part I, “Directors, Senior Management and Employees—A. Directors and Senior Management—Senior Management.” We do not maintain “key person” insurance on any of our senior management.
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Recruiting and retaining qualified operations, finance and accounting, scientific, clinical and sales and marketing personnel will be critical to our success. We may not be able to attract and retain these personnel on acceptable terms, given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. If we are unable to attract, retain and motivate qualified and experienced personnel, we could lose customers and suffer reduced profitability. Even if we are successful in attracting and retaining such personnel, competition for such employees may significantly increase our compensation costs and adversely affect our financial condition and results of operations.
cGMP regulations also require that the personnel we employ and hold responsible for product manufacturing, including, for example, the collection, processing, testing, storage or distribution of blood or blood components, be adequate in number, educational background, training (including professional training as necessary) and experience, or a combination thereof, and have capabilities commensurate with their assigned functions, a thorough understanding of the procedures or control operations they perform, the necessary training or experience and adequate information concerning the application of relevant cGMP requirements to their individual responsibilities. Our failure to attract, retain and motivate qualified personnel may result in a regulatory violation, affect product quality, require the recall or market withdrawal of affected product or result in a suspension or termination of our license to market our products, or any combination thereof.
Our business requires substantial capital to operate and grow and to achieve our strategy of realizing increased operating leverage, including the completion of several large capital projects.
We have implemented several large capital projects to expand and improve the capacity and structure of our facilities and to improve the structure of our plasma collection centers in the United States. These projects may run over budget or be delayed. We cannot be certain that these projects will be completed in a timely manner or that we will maintain our compliance with cGMP regulations, and we may need to spend additional amounts to achieve compliance. Additionally, by the time these multi-year projects are completed, market conditions may differ significantly from our assumptions regarding the number of competitors, customer demand, alternative therapies, reimbursement and public policy, and as a result, capital returns might not be realized.
We also plan to continue to spend substantial sums on research and development, to obtain the approval of the FDA, and other regulatory authorities, for new indications for existing products, to develop new product delivery mechanisms for existing products and to develop innovative product additions. We face a number of obstacles to successfully converting these efforts into profitable products, including, but not limited to, the successful development of an experimental product for use in clinical trials, the design of clinical study protocols acceptable to the FDA and other regulatory authorities, the successful outcome of clinical trials, our ability to scale our manufacturing processes to produce commercial quantities or successfully transition technology, the approval of the FDA and other regulatory authorities of our products and our ability to successfully market an approved product or new indication.
For example, when a new product is approved, the FDA or other regulatory authorities may require post-approval clinical trials, sometimes called Phase IV clinical trials. If the results of such trials are unfavorable, this could result in the loss of the license to market the product, with a resulting loss of sales.
We continually make capital expenditures for the maintenance and enhancement of our facilities. The amount and timing of future capital spending is dependent upon a number of factors, including market conditions, regulatory requirements and the extent and timing of particular projects, among other things. Our ability to grow our business is dependent upon the timely completion of these projects and obtaining the requisite regulatory approvals.
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We may not be able to develop some of our international operations successfully.
We currently conduct sales in over 100 countries. The successful operation of such geographically dispersed resources requires considerable management and financial resources. In particular, we must bridge our business culture to the business culture of each country in which we operate. In addition, international operations and the provision of services in foreign markets are subject to additional risks, such as changing market conditions, currency exchange rate fluctuations, trade wars and barriers, including the imposition of tariffs by the United States or other countries, including China and/or countries in the E.U., on imported goods, exchange controls, regulatory changes, changes to tax regimes (including proposed changes to U.S. tax laws by the Trump administration and the U.S. Congress), foreign investment limitations, civil disturbances, armed conflict and emerging pandemics, as well as changes in global immigration policies that can hinder our ability to obtain visas to work in various countries. Furthermore, if an area in which we have significant operations or an area into which we are looking to expand suffers an economic recession or currency devaluation, our net revenues and accounts receivable collections in that region will likely decline substantially or we may not be able to successfully expand or operate in that region.
Uncertainties regarding the general regulatory and legal environment, particularly in China, could adversely affect our business.
Our international operations are governed by local laws and regulations applicable to foreign investments and foreign-owned enterprises. Our business could be adversely affected by the interpretation and enforcement of and changes in these laws and regulations. These laws and regulations often lack transparency, can be difficult to interpret and may be enforced inconsistently. A significant portion of our revenues is derived from our operations in China. China has not developed integrated legal systems that cover all aspects of our activities. The Chinese legal system is based on written statutes. Prior court decisions may be cited for reference but have limited precedential value. Since 1979, Chinese legislation and regulations have significantly enhanced the protections afforded to various forms of foreign investments in China. Because these laws and regulations are relatively new, and because of the limited volume of published decisions and their nonbinding nature, the interpretation and enforcement of these laws and regulations are uncertain. In addition, the Chinese legal system is based in part on government policies and internal rules that may have retroactive effect and, in some cases, are not published at all. As a result, we may not be aware of any alleged violation of these policies and rules until after the alleged violation has occurred. Any litigation in China may be protracted and result in substantial costs and diversion of resources and management attention. Moreover, the United States and China have had significant disagreements over monetary, economic, political, environmental and social issues at various times during recent years. Changes in political conditions and China-U.S. relations are difficult to predict and could adversely affect our business.
We are susceptible to interest rate variations.
We use issuances of debt and bank borrowings as a source of funding. At December 31, 2025, we had $2.1 billion and €5.7 billion of senior interest-bearing debt outstanding. Of such amounts, 27.0% bore interest at variable rates, at a spread over the Secured Overnight Funding Rate (“SOFR”), for our U.S. dollar denominated debt and at a spread over the Euro Interbank Offered Rate (“EURIBOR”), for our euro denominated debt. Any increase in interest rates payable by us, which could be adversely affected by, among other things, our inability to meet certain financial ratios, would increase our interest expense and reduce our cash flow, which could materially adversely affect our financial condition and results of operations. See Item 11 of this Part I, “Quantitative and Qualitative Disclosures About Market Risk—Interest Rate Risk.”
Our results of operations and financial condition may be affected by adverse changes in foreign currency exchange rates, especially a significant shift in the value of the euro as compared to the U.S. dollar.
A significant portion of our business is conducted in currencies other than our reporting currency, the euro. In 2025, €4.8 billion, or 64.0%, of our net revenue of €7.5 billion was denominated in U.S. dollars. We are also exposed to currency fluctuations with respect to other currencies, such as the British pound, the Brazilian real, the Canadian dollar and the Argentine, Mexican and Chilean pesos. Currency fluctuations among the euro, the U.S. dollar and the other currencies in which we do business result in foreign currency translation gains or losses that could be significant.
We are also exposed to risk based on the payment of U.S. dollar denominated indebtedness. At December 31, 2025, we had approximately $2.1 billion of U.S. dollar denominated senior debt outstanding. See Item 5 of this Part I, “Operating and Financial Review and Prospects—B. Liquidity and Capital Resources” and Item 11 of this Part I, “Quantitative and Qualitative Disclosures About Market Risk—Currency Risk.”
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If our main facilities were to suffer a crippling accident, or if a force majeure event materially affected our ability to operate and produce saleable products, a substantial part of our manufacturing capacity could be shut down for an extended period.
A substantial portion of our revenue is derived from plasma fractionation or products manufactured at our main facilities, including the facilities located in San Diego, Clayton, Emeryville, Los Angeles and Parets. In addition, a substantial portion of our plasma supply is stored at facilities in City of Industry, California, as well as at our Clayton and Parets facilities. If any of our main facilities, including the ones mentioned above, were to be impacted by an accident or a force majeure event such as an earthquake, major fire, storm or explosion, major equipment failure or power failure lasting beyond the capabilities of our backup generators, our revenue would be materially adversely affected. In this situation, our manufacturing capacity could be shut down for an extended period and we could experience a loss of raw materials, work-in-process or finished goods inventory. In addition, extreme weather conditions may become more severe and frequent as the temperature rises due to the effects of climate change, and such extreme weather conditions could heighten the risks and uncertainties noted above.
Other force majeure events such as terrorist acts, armed conflicts, influenza pandemic or similar events could also impede our ability to operate our business. In addition, in the event of the reconstruction of our Clayton, Los Angeles or Parets facilities or our plasma storage facilities, gaining the regulatory approval for such new facilities and the replenishment of raw material plasma could be time consuming. During this period, we would be unable to manufacture all of our products at other plants due to the need for FDA and foreign regulatory authority inspection and certification of such facilities and processes.
Our property damage and business interruption insurance may be insufficient to mitigate the losses from any such accident or force majeure event. We may also be unable to recover the value of the lost plasma or work-in-process inventories, as well as the sales opportunities from the products we would be unable to produce.
If we experience equipment difficulties or if the suppliers of our equipment or disposable goods fail to deliver key product components or supplies in a timely manner, our manufacturing ability would be impaired and our product sales could suffer.
We depend on a limited number of companies that supply and maintain our equipment and provide supplies such as chromatography resins, filter media, glass and stoppers used in the manufacture of our products. If our equipment should malfunction, the repair or replacement of the machinery may require substantial time and cost, which could disrupt our production and other operations. Our plasma collection centers rely on disposable goods supplied by third parties and information technology systems hosted by third parties. Our plasma collection centers cannot operate without an uninterrupted supply of these disposable goods and the operation of these systems. Alternative sources for key component parts or disposable goods may not be immediately available. And while we have experienced periodic outages of these systems, a material outage would affect our ability to operate our collection centers.
Any new equipment or change in supplied materials may require revalidation by us or review and approval by the FDA or other regulatory authorities, including the EMA, which may be time-consuming and require additional capital and other resources. We may not be able to find an adequate alternative supplier in a reasonable time period, or on commercially acceptable terms, if at all. As a result, shipments of affected products may be limited or delayed. Our inability to obtain our key source supplies for the collection of plasma and manufacture of products may require us to delay shipments of products, harm customer relationships and force us to curtail operations.
If our shipping or distribution channels were to become inaccessible due to a crippling accident, a pandemic, an act of terrorism, a strike, earthquake, major fire, armed conflict or storm, or any other force majeure event, our supply, production and distribution processes could be disrupted.
Not all shipping or distribution channels are equipped to transport plasma. If any of our shipping or distribution channels becomes inaccessible due to a crippling accident, a pandemic, an act of terrorism, a strike, earthquake, major fire, armed conflict or storm or any other force majeure event, we may experience disruptions in our continued supply of plasma and other raw materials, delays in our production process or a reduction in our ability to distribute our products directly to our customers.
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We rely in large part on third parties for the sale, distribution and delivery of our products.
We regularly enter into distribution, supply and fulfillment contracts with group purchasing organizations (“GPOs”), home care companies, alternate infusion sites, hospital groups, distributors and others. We are highly dependent on these agreements for the successful sale, distribution and delivery of our products. For example, in the United States, we rely principally on GPOs and on our distributors to sell our immunoglobulin products. If such parties breach, terminate or otherwise fail to perform under these contracts, our ability to effectively distribute our products could be impaired and our business may be materially and adversely affected. In addition, through circumstances beyond our control, such as general economic decline, market saturation or increased competition, we may be unable to successfully renegotiate our contracts or secure terms which are as favorable to us. Furthermore, we rely in certain countries on distributors for sales of our products. Disagreements or difficulties with our distributors supporting our export business could result in a loss of sales.
We rely on the services of third parties for the manufacture of certain products.
We have rights of sale and distribution for several different products, including Tavlesse in the European market. However, for many of these products we rely upon supply from third parties. To the extent such third parties are unable to properly and timely manufacture and deliver the necessary products and services in Europe, our business could be materially affected.
We may not be able to commercialize products in development.
Before obtaining regulatory approval for the sale of our product candidates or for the marketing of existing products for new indicated uses, we must conduct, at our own expense, extensive preclinical tests to demonstrate the safety of our product candidates in animals and clinical trials to demonstrate the safety and efficacy of our product candidates in humans. Preclinical and clinical testing is expensive, is difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more of our clinical trials can occur at any stage of testing. We may experience numerous unforeseen events during, or as a result of, preclinical testing and the clinical trial process that could delay or prevent our ability to receive regulatory approval or commercialize our product candidates, including, without limitation, the following:
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If we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are unable to successfully complete our clinical trials or other testing, if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we may be delayed in or unable to obtain marketing approval or reimbursement for our product candidates, or be unable to obtain approval for indications that are not as broad as intended or have the product removed from the market after obtaining marketing approval.
Our product development costs will also increase if we experience delays in testing or approvals. We do not know whether any preclinical tests or clinical trials will begin as planned, will need to be restructured or will be completed on schedule, if at all. Significant preclinical or clinical trial delays could also shorten the patent protection period during which we may have the exclusive right to commercialize our product candidates or could allow our competitors to bring products to market before we do, impairing our ability to commercialize our products or product candidates.
Even if preclinical trials are successful, we still may be unable to commercialize a product due to difficulties in obtaining regulatory approval for its engineering process or problems in scaling that process to commercial production. Additionally, if produced, a product may not achieve an adequate level of market acceptance by physicians, patients, healthcare payors and others in the medical community to be profitable. The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, some of which are beyond our control, including the following:
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Therefore, we cannot guarantee that any products we may seek to develop will ever be successfully commercialized, and to the extent they are not successfully commercialized, such products could involve significant expense with no corresponding revenue.
Complex and evolving U.S. and international laws and regulations regarding privacy and data security and increased risk of cybersecurity incidents to our information technology systems could result in increased costs of operations and a significant disruption to our business.
Our operations are highly dependent on our information technology systems, including internet-based systems, which may be vulnerable to breakdown, cybersecurity incidents, wrongful intrusions, data breaches, malware, ransomware, and malicious attack. In addition, information security risks have generally increased in recent years, increasing our systems’ potential vulnerability, such as to data security breaches or cyber-attack, whether by employees or others, which may expose sensitive data to unauthorized persons. Such data security breaches could lead to the loss of trade secrets or other intellectual property, or could lead to the public exposure of personal information (including sensitive personal information) of our employees, customers, plasma donors and others. Data security breaches may also adversely impact the conduct of scientific research and clinical trials, including the submission of research results to support marketing authorizations.
Additionally, our information technology systems utilize certain third-party service organizations that manage sensitive data, such as personal medical information regarding plasma donors, and our business may be adversely affected if these third-party service organizations are subject to data security breaches. We may continue to incur significant expenses to comply with existing privacy and security standards and protocols imposed by law, regulation, industry standards or contractual obligations.
In addition to the E.U.’s General Data Protection Regulation (“GDPR”), which entered into force in 2016, the California Consumer Protection Act (“CCPA”), effective as of January 1, 2020, and the U.S. Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (“HIPAA”), federal, state and foreign governments continue to adopt new, or modify existing laws and regulations addressing data privacy and the collection, processing, storage, transfer and use of data.
In the United States, an increasing number of federal, state, and local privacy, data security and breach notification laws have been enacted, and additional legislation has been proposed. As of January 1, 2026, comprehensive privacy laws are in effect in 20 states, further complicating our privacy compliance obligations through the introduction of increasingly disparate requirements across the various U.S. jurisdictions in which we operate. Certain states have also enacted or are considering laws that impose stricter requirements on the processing of health-related data. While Congress is considering legislation that may preempt some or all of such U.S. state privacy laws, such legislation may also provide a more expansive private right of action for privacy claims than exists under current state laws.
Our use of personal information in connection with data analytics and emerging technologies, including artificial intelligence, may be subject to additional privacy constraints. Regulators in multiple jurisdictions have implemented or are considering new privacy and AI-specific legal frameworks, and any failure or perceived failure by us to comply with such requirements could lead to regulatory investigations, enforcement actions, fines, or restrictions on data use. We may also face enforcement risk where our partners, vendors, or service providers leverage AI in ways that involve personal data, even if we do not control the underlying technology.
In our efforts to comply with these laws and regulations, we have made and continue to make certain operational changes to our business practices. Other governmental authorities throughout the United States and around the world are considering similar types of legislative and regulatory proposals concerning data protection. These privacy, security and data protection laws and regulations could impose increased business operational costs, require changes to our business, require notification to customers or workers of a security breach, or restrict our use or storage of personal information.
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For example, health information laws and regulations, such as regulations under HIPAA and potential revisions thereto, include requirements to implement various recordkeeping, operational, notice and other practices intended to safeguard that information, limit its use to allowed purposes and notify affected individuals in the event of privacy and security breaches, establish standards regarding electronic health data transmissions and set rules for specific electronic transactions, such as transactions involving claims submissions to third party payers. Failure to comply with HIPAA and similar state laws currently in effect or enacted in the future could expose us to breach of contract claims, substantial fines, penalties and other liabilities and expenses, costs for remediation and harm to our reputation.
The European Parliament and the Council of the European Union adopted the GDPR, which increased privacy rights for individuals in Europe, extended the scope of responsibilities for data controllers and data processors and imposed increased requirements and potential penalties on companies offering goods or services to individuals who are located in Europe or monitoring the behavior of such individuals (including by companies based outside of Europe). Noncompliance can result in penalties of up to the greater of €20 million, or 4.0% of global company revenues. In addition, the Network and Information Security Directive (NIS2) was approved by the Council of the European Union. While some member states have yet to transpose the NIS2 into law (despite the October 2024 deadline), once effective in each E.U. member state the NIS2 imposes enhanced cybersecurity risk management and incident reporting obligations on certain entities, including those operating in healthcare and life sciences sectors. To the extent entities in our Group are or become subject to NIS2, compliance with these requirements may increase our operational and compliance costs and expose us to additional regulatory scrutiny and potential fines in case of noncompliance.
Moreover, data sovereignty regulations increasingly restrict cross-border data flows critical to our activities. Accelerating geopolitical tensions have transformed data sovereignty from focusing primarily on privacy concerns to focusing on national security imperatives, as evidenced by the U.S. Data Security Program (DSP). Our early-stage pipeline development, M&A activities, digital transformation initiatives, AI scaling ambitions, and end-to-end supply chain all depend on cross-border data flows now subject to increasing restrictions. For example, the recent U.S. Executive Order on Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern prohibits or restricts specific types of commercial transactions involving “bulk sensitive personal data,” to “countries of concern,” including China. Such rules and regulations could have a material adverse impact on our business, results of operations or financial condition, including due to our diverse portfolio, our extensive research activities, the fragmented digital landscape with which we are forced to comply, our extensive third-party relationships, and our global supply chain.
Our efforts to implement programs and controls that comply with the GDPR, HIPAA, the multitude of general and sector- or data-specific U.S. state privacy laws, NIS2, data sovereignty and other data protection requirements are likely to impose additional costs on us, and we cannot predict whether the interpretations of the requirements, or changes in our practices in response to new requirements or interpretations of the requirements, could have a material adverse effect on our business.
Cyber-attacks or other privacy and data security incidents (for example involving the personal information of our plasma or blood donors) could disrupt our business and expose us to significant losses, liability and reputational damage.
We and our third-party service providers routinely process, store and transmit large amounts of data in our operations, including sensitive personal information as well as proprietary or confidential information relating to our business or third parties, including our plasma or blood donors. We may be subject to breaches of the information technology security systems we use both internally and externally with third-party service providers.
Cyber-attacks may penetrate our and our third-party service providers’ security controls and result in the misappropriation or compromise of sensitive personal information or proprietary or confidential information (e.g. information regarding our plasma or blood donors), including such information which is stored or transmitted on the systems used by certain of our or their products, to create system disruptions, cause shutdowns (including disruptions to our production plants), or deploy viruses, worms, ransomware, denial-of-service attacks and other malicious software programs that attack our systems. We and our third-party service providers handle the personal information of our patients and beneficiaries, patient personal data, throughout the United States and other parts of the world. We or our business associates may experience data breaches in violation of the requirements of HIPAA, GDPR, NIS2 and/or other similar laws, for example:
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When appropriate, we have filed complaints against the unknown attackers with the relevant authorities, and we have contacted the patients who were affected by the illegal data publication as well as any relevant regulatory authorities and other stakeholders. While there has not been any material impact to our financial condition and operations as a result of these data breaches and attacks, future cyber-attacks against our IT systems may result in a loss of financial data or interruptions of our operations that could have a material adverse impact on our business, financial condition and results of operations in the future. The current military conflicts have increased the risk of cyber-attacks against our systems and data.
As we increase the amount of sensitive personal information or financial data that we store and share digitally, our exposure to these privacy and data breaches and cyber-attack risks increases (particularly as medical or pharmaceutical records are a high-value target), including the risk of undetected attacks, damage, loss or unauthorized disclosure or access, and the cost of attempting to protect against these risks also increases. There are no assurances that our security technologies, processes and procedures that we or our outside service providers have implemented to protect sensitive personal information and proprietary or confidential information and to build security into the design of our products will be effective.
Any failure to keep our information technology systems, financial data and our patients’ and customers’ sensitive information secure from attack, damage, loss or unauthorized disclosure or access, whether as a result of our action or inaction or that of our third-party business associates or vendors that utilize and store such personal information on our behalf, could materially adversely affect our reputation and ability to continue normal operations, expose us to mandatory public disclosure requirements, litigation and governmental enforcement proceedings, material fines, penalties and/or remediation costs, and compensatory, special, punitive and statutory damages, consent orders and other adverse actions, any of which could have a material adverse impact on our business, financial condition and results of operations. For information regarding our cybersecurity risk management and governance, see Item 16K of Part II of this annual report, “Cybersecurity.”
Our success depends in large part on our ability to obtain and maintain protection in the United States and other countries of the intellectual property relating to or incorporated into our technology and products.
Our success depends in large part on our ability to obtain and maintain protection in the United States and other countries for the intellectual property covering or incorporated into our technology and products, especially intellectual property related to our purification processes. The patent landscape in the field of biotechnology and pharmaceuticals generally is highly uncertain and involves complex legal and scientific questions. We may not be able to obtain additional issued patents relating to our technology or products. Even if patents are issued to us or to our licensors, they may be challenged, narrowed, invalidated, held to be unenforceable or circumvented, which could limit our ability to stop competitors from marketing similar products or limit the length of time our products have patent protection. Additionally, most of our patents relate to the processes we use to produce our products, not to the products themselves. In many cases, the plasma-derived products we produce or develop in the future will not, in and of themselves, be patentable. Since our patents relate to processes, if a competitor is able to design and utilize a process that does not rely on our protected intellectual property, such competitor could sell a plasma-derived or other product similar to one we developed or sell.
Our patents also may not afford us protection against competitors with similar technology. Because patent applications in the United States and many other jurisdictions are typically not published until 18 months after their filing, if at all, and because publications of discoveries in the scientific literature often lag behind actual discoveries, neither we nor our licensors can be certain that we or they were the first to make the inventions claimed in our or their issued patents or pending patent applications, or that we or they were the first to file for protection of the inventions set forth in such patent applications. If a third party has also filed a U.S. patent application covering our product candidates or a similar invention, we may be required to participate in an adversarial proceeding, known as an “interference proceeding,” declared by the U.S. Patent and Trademark Office to determine priority of invention in the United States. The costs of these proceedings could be substantial and our efforts in them could be unsuccessful, resulting in a loss of our anticipated U.S. patent position.
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Our patents expire at various dates. Our pending and future patent applications may not issue as patents or, if issued, may not issue in a form that will provide us with any competitive advantage. Even if issued, we cannot guarantee that: any of our present or future patents or patent claims or other intellectual property rights will not lapse or be invalidated, circumvented, challenged or abandoned; our intellectual property rights will provide competitive advantages; our ability to assert our intellectual property rights against potential competitors or to settle current or future disputes will not be limited by our agreements with third parties; any of our pending or future patent applications will be issued or have the coverage originally sought; our intellectual property rights will be enforced in jurisdictions where competition may be intense or where legal protection may be weak; or we will not lose the ability to assert our intellectual property rights against, or to license our technology to, others and collect royalties or other payments. In addition, our competitors or others may design around our protected patents or technologies.
Effective protection of our intellectual property rights may be unavailable, limited or not applied for in some countries. Changes in patent laws or their interpretation in the United States and other countries could also diminish the value of our intellectual property or narrow the scope of our patent protection. In addition, the legal systems of certain countries do not favor the aggressive enforcement of patents, and the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. In order to preserve and enforce our patent and other intellectual property rights, we may need to make claims or file lawsuits against third parties. Such lawsuits could entail significant costs to us and divert our management’s attention from developing and commercializing our products.
We, like other companies in the pharmaceutical industry, may become aware of counterfeit versions of our products becoming available domestically and abroad. Counterfeit products may use different and possibly contaminated sources of plasma and other raw materials, and the purification process involved in the manufacture of counterfeit products may raise additional safety concerns, over which we have no control. Any reported adverse events involving counterfeit products that purport to be our products could harm our reputation and the sale of our products in particular and consumer willingness to use plasma-derived therapeutics in general.
Unauthorized use of our intellectual property may have occurred or may occur in the future. Although we have taken steps to minimize this risk, any failure to identify unauthorized use and otherwise adequately protect our intellectual property would adversely affect our business. For example, any unauthorized use of our trademarks could harm our reputation or commercial interests. Moreover, if we are required to commence litigation related to unauthorized use, whether as a plaintiff or defendant, such litigation would be time consuming, force us to incur significant costs and divert our attention and the efforts of our management and other employees, which could, in turn, result in lower revenue and higher expenses.
In addition to patented technology, we rely on our unpatented proprietary technology, trade secrets, processes and know-how.
We generally seek to protect proprietary information by entering into confidentiality agreements with our employees, consultants, scientific advisors and third parties. These agreements may not effectively prevent disclosure of confidential information, may be limited as to their term and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, our trade secrets may otherwise become known or be independently developed by our competitors or other third parties. To the extent that our employees, consultants or contractors use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions. Costly and time-consuming litigation could be necessary to determine and enforce the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position. We also rely on contractual protections with our customers, suppliers, distributors, employees and consultants and implement security measures designed to protect our trade secrets. We cannot assure you that these contractual protections and security measures will not be breached, that we will have adequate remedies for any such breach or that our suppliers, employees or consultants will not assert rights to intellectual property arising out of such contracts.
Since we rely on trade secrets and nondisclosure agreements, in addition to patents, to protect some of our intellectual property, there is a risk that third parties may obtain and improperly utilize our proprietary information to our competitive disadvantage. We may not be able to detect the unauthorized use of such information, prevent such use or take appropriate and timely steps to enforce our intellectual property rights.
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We may infringe or be alleged to infringe intellectual property rights of third parties.
Our products or product candidates may infringe or be accused of infringing one or more claims of an issued patent or may fall within the scope of one or more claims in a published patent application that may be subsequently issued and to which we do not hold a license or other rights. Third parties may own or control these patents or patent applications in the United States and/or abroad. These third parties could bring claims against us or our collaborators that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial damages. Further, if a patent infringement suit were brought against us or our collaborators, we or they could be forced to stop or delay research, development, manufacturing or sales of the product or product candidate that is the subject of the suit.
If we are found to be infringing on the patent rights of a third party, or in order to avoid potential claims, we or our collaborators may choose or be required to seek a license from a third party and be required to pay license fees or royalties or both. These licenses may not be available on acceptable terms, or at all. Even if we or our collaborators were able to obtain a license, the rights may be nonexclusive, which could result in our competitors gaining access to the same intellectual property. Ultimately, we could be prevented from commercializing a product, or be forced to cease some aspect of our business operations, if, as a result of actual or threatened patent infringement claims, we or our collaborators are unable to enter into licenses on acceptable terms.
There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical and biotechnology industries. In addition to infringement claims against us, we may become a party to other patent litigation and other proceedings, including interference proceedings declared by the U.S. Patent and Trademark Office and opposition proceedings in the European Patent Office, regarding intellectual property rights with respect to our products. The cost to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their substantially greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. Patent litigation and other proceedings may also absorb significant management time.
Many of our employees were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. We take steps to ensure that our employees do not use the proprietary information or know-how of others in their work for us. We may, however, be subject to claims that we or these employees have inadvertently or otherwise used or disclosed intellectual property, trade secrets or other proprietary information of any such employee’s former employer. Litigation may be necessary to defend against these claims and, even if we are successful in defending ourselves, could result in substantial costs to us or be distracting to our management. If we fail to defend any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.
We have in-licensed certain patent rights and co-own certain patent rights with third parties.
Our rights in certain intellectual property that we have in-licensed or co-own with third parties and the value therein may depend on our third party licensors’ or co-owners’, as applicable, performance under our intellectual property agreements with them. If one of these third parties is unable to, or does not, enforce their own rights in such intellectual property or perform under our agreements with them, it could affect our ability to effectively compete in the marketplace and operate our business.
Our in-license agreements for certain patent rights may impose payment and/or other material obligations on us as a licensee. Although we are currently in compliance with all of our material obligations under these licenses, if we were to breach any such obligations, our counterparty licensors may be entitled to terminate the licenses. Such termination may restrict, delay or eliminate our ability to develop and commercialize our products, which could adversely affect our business. We cannot guarantee that the third-party patents and technology we license will not be licensed to our competitors. In the future, we may need to obtain additional licenses, renew existing license agreements or otherwise replace existing technology. We are unable to predict whether these license agreements can be obtained or renewed or whether the technology can be replaced on acceptable terms, or at all.
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We may not realize the expected benefits from the entry into new or amended contracts, cost-savings and business improvement initiatives.
We recently acquired plasma collection centers from ImmunoTek GH, LLC (in 2024 and 2025), from Canadian Plasma Resources Corporation (“CPR”) (via the purchase of a single center in 2023 and then our acquisition of CPR itself in 2025), Haema Plasma Kft. (in 2024), Biotest GmbH & Co. KGaA (formerly known as Biotest AG) (“Biotest”) (in 2022), from BPL Plasma Inc. and Kedplasma, LLC (in 2021), from South Korean firm GC Pharma (Group) (“GC Pharma”) (in 2020) and the Interstate Blood Bank Group (in 2019), among others. There can be no assurance we will be successful with this plasma acquisition strategy or that we will realize all of the benefits we expect from such new centers. Moreover, we have implemented a cost savings plan to reduce headcount, become more efficient in the plasma procurement process and close certain underperforming plasma centers, among other strategies. See Item 5 of this Part I “A. Operating Results—Factors Affecting Our Financial Condition and Results of Operations—Operational Improvement Plan.” Our cost savings and business improvement initiatives could result in unexpected charges and expenses that negatively impact our financial results and we could fail to achieve the desired efficiencies and estimated cost savings. In addition, if we are not able to effectively implement these initiatives, or if they fail to operate as intended, our financial results could be adversely affected. Additionally, these types of initiatives could yield unintended consequences such as distraction of management and employees, business disruption, an inability to attract or retain key personnel, which could negatively affect our business or financial condition and results of operations. If we are not able to effectively develop, implement and manage our cost savings or business improvement initiatives (including our acquisitions), we may experience operational difficulties and increased costs, which may adversely affect our results of operations.
Climate change and increased risk of major natural disasters may adversely affect our business.
Climate change is already causing extreme heat and poor air quality in some areas, which threaten to exacerbate pre-existing health conditions such as respiratory diseases. In addition, an increase in temperature and humidity may cause a proliferation of insects that carry vector-borne diseases, including dengue fever and malaria. Ultimately, climate change could undermine decades of progress in improving human health at a time when antimicrobial resistance is also rising.
We are exposed to climate risks such as physical risks (e.g., heat, water scarcity, sea level rise, flooding from severe weather events) and transition risks (e.g., regulatory frameworks, carbon pricing, cost of and access to capital), which could vary in magnitude and impact country by country. For example, some of our production facilities that depend on the availability of significant water supplies are located in areas where water is increasingly scarce. Other facilities are located in places that, because of increasingly violent weather events, sea level rise, or both, are increasingly at risk of substantial flooding. In regions where this risk is present, it impacts not only our own operations but also our distribution supply chain. Such events may result in increased costs, business interruptions, destruction of facilities, loss of life, and disruption to healthcare systems that patients use to access our medicines.
Climate change has triggered the adoption of new regulatory requirements across the globe. For example, recent legislation in California has expanded requirements for companies to report greenhouse gas emissions, which may indirectly result in increased requirements to invest in technology to reduce energy use, water use and greenhouse gas emissions, beyond what we expect to invest in our existing plans. Item 4 of this Part I, “Information on the Company—B. Business Overview—Climate Change.” In addition, legislation could include carbon pricing, climate risk disclosure mandates, and changes in zoning or building codes to increase climate resilience. The combined impact of these transition risks could increase our direct operating costs and result in the same impact across our supply chain.
Changes, enactment, and/or enforcement of biometric information, consumer health data, biometric information, information and other privacy laws of different jurisdictions, including federal and state laws in the United States, could expose us to potential liability.
Regulatory authorities and governments around the world have implemented and are considering further legislative and regulatory proposals regarding biometric information privacy. New laws and regulations governing biometric information privacy and data protection imposing more stringent requirements may be introduced in various jurisdictions, including the United States, the European Union and the United Kingdom. Complying with laws and regulations for an increasing number of jurisdictions could require significant resources and costs, including those associated with adapting our facilities, products or processes.
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In the United States, there are various laws and regulations concerning biometric data privacy and data protection, and certain U.S. state laws may be more stringent or broader in scope, or offer greater individual rights, with respect to personal information than federal, international or other state laws, and such laws may differ from each other, all of which may complicate compliance efforts. U.S. federal and state regulators, including the Federal Trade Commission (the “FTC”), have engaged in enforcement actions focused on biometric information.
Various state privacy laws, such as the Biometric Information Privacy Act in Illinois (the “BIPA”), the Capture or Use of Biometric Identifier Act in Texas (the “CUBI”) and the My Health My Data Act in Washington (the “MHMD”) restrict the collection and use of biometric identifiers and biometric information. Multiple class action lawsuits have been brought under BIPA’s private right of action, and BIPA has generally been broadly interpreted by the courts. In the past, we were named in a class action lawsuit that alleged that we failed to comply with BIPA’s requirements when collecting fingerprint data of plasma donors. The lawsuit was subsequently settled.
Any future similar legal proceedings and any government enforcement actions we may become subject to under applicable privacy and data protection laws may cause us significant losses in addition to legal costs, which could adversely affect our business, results of operations and financial condition. In addition, any failure, or perceived failure, by us to comply with the above and other regulatory requirements or biometric information privacy and data protection-related laws, rules and regulations could result in reputational damages or proceedings or actions against us by governmental entities, consumers or other parties. Such proceedings or actions could subject us to significant penalties and negative publicity, require us to change our data and other business practices, increase our costs and severely disrupt our business or hinder our global expansion.
Risks Relating to the Healthcare Industry
United States Healthcare Reform may adversely affect our business.
The United States Patient Protection and Affordable Care Act and the companion Healthcare and Education Reconciliation Act, each enacted in March 2010, as amended (collectively, the “ACA”), increased federal oversight of private health insurance plans and included a number of provisions designed to reduce Medicare expenditures and the cost of health care generally, to reduce fraud and abuse, and to provide access to increased health coverage. While the ACA has materially expanded the number of individuals in the United States with health insurance, it has faced ongoing legal challenges, including federal litigation seeking to invalidate some of or all of the law or the manner in which it has been interpreted, and could have a significant impact on the United States healthcare industry.
There are also uncertainties due to federal legislative and administrative efforts to repeal, substantially change, replace or invalidate portions or all of the ACA. The One Big Beautiful Bill Act (“OBBBA”), signed into law on July 4, 2025, includes a number of provisions that are expected to result in reductions in the number of Medicaid enrollees, as well as reductions in federal funding to state Medicaid programs, resulting in potentially adverse impacts on utilization of services and coverage of products. Any future legislation, guidance, rules or regulations and/or executive orders that materially alter the healthcare industry could have a significant impact on our operations. The uncertain status of the ACA affects our ability to plan, and its repeal without adequate replacement could have a material adverse effect on our United States operations.
Government pressures and constraints on reimbursement may adversely affect our business.
We engage in various manufacturing, processing, marketing and sales activities pertaining to pharmaceutical products in a number of jurisdictions around the world. These activities subject us to several governmental regulations mandating multiple types of controls over pricing and general operations in the various countries in which we operate. The growth of overall healthcare costs as a percentage of gross domestic product in many countries means that governments and payers are under intense pressure to control spending even more tightly. In addition to ongoing cost containment pressures, healthcare pricing frameworks in key markets are subject to significant structural reform and policy shifts, including reforms that may alter the mechanisms by which prices are set, negotiated, benchmarked or subject to rebates, inflation penalties or other direct government intervention. Such reforms may be implemented rapidly and could materially affect the pricing, reimbursement levels and commercial viability of our products.
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In the United States, which is our main market, trends in recent years in the healthcare industry have caused significant changes including a shift towards managed or value-based care, collective purchasing agreements, consolidation in office-based healthcare providers, and other cost-saving, revenue and payment reduction measures with respect to, for example, several government healthcare programs that cover our products, including Medicaid, Medicare Parts B and D and the 340B Program. Recent U.S. legislative and regulatory developments, including provisions of the Inflation Reduction Act of 2022 and related rulemakings, introduce mechanisms for direct government price negotiation, inflation-based rebate obligations and expanded manufacturer discount requirements, and may result in increased rebate liabilities, lower net realized prices, reduced reimbursement levels or changes in product demand. The interpretation, implementation and potential expansion of these measures remain subject to evolving regulatory guidance and legal challenges. These trends could have a material adverse impact on our financial performance. Global emphasis on healthcare cost containment exerts significant pressures on the pricing of our products and on our ability to obtain and maintain reimbursement rates to cover our products, which may adversely affect our business.
In addition, the availability of federal funds to pay for our products under Medicaid and Medicare requires that we extend discounts under the 340B Program, and changes to this program could adversely affect our financial performance. The 340B Program extends discounts to a variety of eligible entities, including community health clinics and certain other entities that receive certain governmental healthcare grants, as well as hospitals that serve a disproportionate share of certain low income individuals, and certain cancer centers, children’s hospitals, critical access hospitals and rural referral centers. The 340B Program price, or ceiling price, cannot exceed the average manufacturer price (“AMP”) (as reported to the U.S. Centers for Medicare & Medicaid Services (“CMS”) under the Medicaid drug rebate program) less the Medicaid unit rebate amount. We have entered into a pharmaceutical pricing agreement (“PPA”), with the government in which we have agreed to participate in the 340B Program by charging eligible entities no more than the ceiling price for drugs intended for outpatient use. Evolving requirements with respect to this program continue to be issued by the Health Resources and Services Administration (“HRSA”) of the United States Department of Health and Human Services (“HHS”), the federal agency responsible for oversight of the 340B Program, which creates uncertainty, and certain aspects of the 340B Program, such as relating to manufacturers’ 340B pricing restrictions for prescriptions filled at contract pharmacy locations, continue to be challenged in federal courts, which adds to such uncertainty. In December 2025, a federal court in Maine preliminarily enjoined the HRSA’s 340B Rebate Model Pilot Program, which would have replaced upfront discounts with a retroactive rebate for ten drugs. In February 2026, HRSA officially withdrew its 340B Rebate Model Pilot Program and subsequently issued a request for information seeking comments on launching a new 340B Program rebate model. We believe that we meet the requirements of the 340B Program, and are continuing to review and monitor these and other developments affecting the 340B Program.
Continuing efforts of certain regulatory and legislative bodies, as well as the United States Congress, are focused on pricing and reimbursement, and we expect that the healthcare industry will continue to be subject to increasing pricing and cost containment pressures in 2026 and beyond. These pricing and cost containment pressures may impact the reimbursement rates for our products and have an adverse effect on our business. For more details, see Item 4 of this Part I, “E. Regulatory Matters—Pharmaceutical Pricing and Reimbursement.”
Impact of government regulations relating to product development and regulatory approvals may adversely affect our business.
We develop and manufacture pharmaceutical products in a number of jurisdictions around the world. These activities subject us to several governmental regulations mandating specific governmental approvals that are necessary for us to develop our products in the various countries in which we operate. Obtaining market approval for our products is a lengthy, costly and complex regulatory process that requires intensive preclinical and clinical data, and the approval process can vary significantly depending on the regulatory authority of each jurisdiction. Relevant health authorities may, at the time of the filing of the application for a marketing authorization, or later during their review, impose requirements that can evolve over time, including requiring additional clinical trials, and such authorities may delay or refuse to review our application or grant market approval. Also, the centrality to our business of government regulatory oversight by relevant health authorities exposes us to risks of administrative and enforcement changes or delays, including as may derive from health authorities’ staffing levels or resources, including as a result of a government shutdown. For example, the development and regulatory approval of new products may be delayed due to reductions to the FDA’s budget and staffing, which may lead to slower response times and longer review periods.
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Even where we have obtained marketing approval for a product in one or more major markets, we may need to invest significant time and resources in applying for approval in other markets, and there is no assurance that we will be able to obtain such approval. In recent years, health authorities have become increasingly focused on product safety and on the risk/benefit profile of pharmaceutical products, which could lead to more burdensome and costly approval processes and negatively affect our ability to obtain regulatory approval for products under development. For example, the FDA and the EMA have been implementing strict requirements for approval, particularly in terms of the volume of data needed to demonstrate a product’s efficacy and safety. In December 2025, the Council of the European Union and the European Parliament reached provisional agreement on a comprehensive overhaul of the EU legislative framework for pharmaceuticals. There are a number of significant changes, including a potential reduction in regulatory data protection, a streamlining of the regulatory approval process potentially allowing products to reach the market in a shorter period of time, and introduction of shortage prevention plans. The agreement still requires formal approval and adoption, but, if adopted, may have a significant impact on the pharmaceutical industry in general and our business.
In the United States, our main market, there is an abbreviated regulatory approval pathway for biological products found to be “biosimilar” to or “interchangeable” with a biological “reference product” previously licensed under a Biologics License Application (“BLA”). This abbreviated approval pathway is intended to permit a biosimilar product to come to market more quickly and less expensively by relying to some extent on the data generated by the reference product’s sponsor, and the FDA’s previous review and approval of the reference product.
The law provides that no biosimilar application may be accepted for FDA review until four years after the date the reference product was first licensed by the FDA, and that the FDA may not make approval of an application effective until 12 years after the reference product was first licensed. The law also includes an extensive process for the innovator biologic and biosimilar manufacturer to litigate patent infringement, validity, and enforceability, which could increase costs of protecting our reference products. In addition, the Creating and Restoring Equal Access to Equivalent Samples Act of 2019 authorizes sponsors of abbreviated new drug applications, 505(b)(2) NDAs or biosimilar product applications to bring actions against NDA or BLA holders that decline to provide sufficient quantities of an approved reference product on commercially reasonable, market-based terms. If a court determines that a reference product sponsor failed to provide such quantities without a legitimate business justification, the court may order the provision of product without delay and may award reasonable attorney fees and costs and, in certain circumstances, damages in an amount sufficient to deter such conduct. Although we intend to comply with applicable statutory requirements, we may be exposed to litigation and related costs, damages and reputational harm, and such provisions may facilitate competition with our products.
Once approved, biosimilars likely would compete with, and in some circumstances may be deemed under applicable laws to be “interchangeable with,” the previously approved reference product. The extent to which a biosimilar product, once approved, will be substituted for any of our products, in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing. For example, in October 2025, the FDA issued draft guidance that proposes to eliminate the need for sponsors of biosimilar products to conduct comparative human clinical efficacy studies. In connection with the FDA’s authority to ensure the development of safe and effective biosimilars, in September 2022, the FDA Biosimilar User Fee Amendments of 2022 were signed into law. The FDA Biosimilar User Fee Amendments of 2022 reauthorize for an additional five years (through 2027) the Biosimilar User Fee Act of 2012, which allows the FDA to assess and collect fees for biosimilars. While the fee rates charged to biosimilar program sponsors are intended to expedite the process for reviews of biosimilar applications, it is unknown how such fees will be passed on in the future, which could also impact our financial results. We expect in the future to face greater competition from biosimilar products, including a possible increase in patent challenges, all of which could adversely affect our financial performance.
Regarding access to our products, the ACA established and provided significant funding for a Patient-Centered Outcomes Research Institute to coordinate and fund Comparative Effectiveness Research, as those terms are defined in the ACA. While the stated intent of Comparative Effectiveness Research is to develop information to guide providers to the most efficacious therapies, outcomes of Comparative Effectiveness Research could influence the reimbursement or coverage for therapies that are determined to be less cost effective than others. Should any of our products be determined to be less cost effective than alternative therapies, the levels of reimbursement for these products, or the willingness to reimburse at all, could be impacted, which could materially impact our financial results. In connection with the FDA’s authority to ensure the development of safe and effective biosimilars, in September 2022, the FDA User Fee Reauthorization Act of 2022 was signed into law, which allows the FDA to assess and collect fees for biosimilars for a five-year period through 2027. While the fee rates charged to biosimilar program sponsors are intended to expedite the process for reviews of biosimilar applications, such fees could be passed onto manufacturers and, thus, could also impact our financial results.
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Failure to comply with laws and regulations governing the sales and marketing of our products or an adverse decision in lawsuits may result in adverse consequences for us.
We engage in various marketing, promotional and educational activities pertaining to, as well as the sale of, pharmaceutical products in a number of jurisdictions around the world. The promotion, marketing and sale of pharmaceutical products and medical devices is highly regulated and the sales and marketing practices of market participants such as us have been subject to increasing supervision by governmental authorities around the world, and we believe that this trend will continue.
For example, the laws governing our conduct in the United States are enforceable by criminal, civil and administrative penalties. Violations of laws such as the Federal Food, Drug and Cosmetic Act (“FDCA”), the Federal False Claims Act (“FCA”), the Public Health Service Act (“PHS Act”) or provisions of the U.S. Social Security Act known as the “Anti-Kickback Statute” and the “Civil Monetary Penalties Law,” or any regulations promulgated under their authority, may result in jail sentences, fines or exclusion from federal and state programs, as may be determined by Medicare, Medicaid, the Department of Defense, other regulatory authorities and the courts. There can be no assurance that our activities will not come under the scrutiny of regulators and other government authorities or that our practices will not be found to violate applicable laws, rules and regulations or prompt lawsuits by private citizen “relators” under federal or state false claims laws. For a description of fraud and abuse laws see Item 4 of this Part I, “Information on the Company—E. Regulatory Matters—Government Regulation—United States Government Regulation—Anti-fraud and Abuse Regulation.”
Failure to comply with fraud and abuse laws and regulations could also result in other significant civil and criminal penalties and costs, including the loss of licenses and the inability to participate in federal and state health care programs, and could have a material adverse effect on our business. In addition, these measures may be interpreted or applied by a prosecutorial, regulatory or judicial authority in a manner that could require us to make changes in our operations or incur substantial defense and settlement expenses. Fraud and abuse laws and regulations have been subject to heightened enforcement activity over the past few years. Since the ACA significantly strengthened provisions of the FCA, the anti-kickback provisions of Medicare and Medicaid and other healthcare antifraud provisions, there have also been a greater number of qui tam suits brought by “relator” whistleblowers, who may receive up to 30% of total government recoveries. Even unsuccessful challenges by regulatory authorities or private relators could result in reputational harm and the incurring of substantial costs. Further, many of these laws are vague or indefinite and have not been interpreted by the courts, and have been subject to frequent modification and varied interpretation by prosecutorial and regulatory authorities, increasing the risk of noncompliance. Most states have adopted similar state false claims laws, and these state laws have their own penalties which may be in addition to FCA penalties, as well as other fraud and abuse laws. While we believe that we are substantially compliant with applicable fraud and abuse laws and regulations, and have adequate compliance programs and controls in place to ensure substantial compliance, we cannot predict whether changes in applicable law, or interpretation of laws, or changes in our services or marketing practices in response to changes in applicable law or interpretation of laws, could have a material adverse effect on our business.
Failure to satisfy requirements under the FDCA can also result in penalties, as well as requirements to enter into consent decrees or orders that prescribe allowable corporate conduct. In this regard, our Los Angeles facility was previously managed pursuant to a consent decree that was entered into in February 1998 based on action by the FDA and the U.S. Department of Justice (the “DOJ”), addressing FDCA violations committed by the former owner of the facility, Alpha Therapeutic Corporation (“Alpha”). The consent decree provided for annual inspection of the plant by the FDA. On March 15, 2012, the United States District Court for the Central District of California entered an order vacating the consent decree on the Los Angeles facility.
Adverse consequences can also result from failure to comply with the requirements of the 340B Program under the PHS Act, which extends discounts to a variety of community health clinics and other entities that receive health services grants under the PHS Act (the “340B Program”). In early 2016, HRSA finalized a regulation regarding the 340B Program pricing methodology, providing. HRSA regulations prescribes when civil monetary penalties may be issued for “knowing and intentional” manufacturer overcharges of 340B Program covered entities, and provides that manufacturers who overcharge may be subject to significant monetary penalties. Such findings could also result in negative publicity that could harm the manufacturer’s reputation or cause business disruption, penalties, or CMP. Under the HRSA regulations, the CMP may be up to $5,000 for each instance of overcharging a covered entity. If we are ultimately required to change our sales or pricing practices with regard to the distribution of drugs under the 340B Program, or if we were required to pay penalties under the applicable regulations, there would be an adverse effect on our revenues and profitability.
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In addition, companies in the United States, Canada and the European Union are generally restricted from promoting approved products for other indications that are not specifically approved by the competent regulatory authorities, nor can companies promote unapproved products. Improper promotion of unapproved drugs or devices or unapproved indications for a drug or device may subject us to warnings from, or enforcement action by, regulatory authorities, harm demand for our products, and subject us to civil and criminal sanctions. Further, sanctions under the FCA have been brought against companies accused of promoting off-label uses of drugs, and the DOJ has increasingly scrutinized off-label drug promotion in recent years, because such promotion induces the use and subsequent claims for reimbursement under Medicare and other federal programs. Industry data indicates that a significant portion of IVIG volume may be used to fill physician prescriptions for indications not approved by the FDA or similar regulatory authorities. Violations or allegations of violations of the foregoing restrictions could materially and adversely affect our business.
We are required to report detailed pricing information, net of applicable discounts, rebates and other concessions, to CMS for the purpose of calculating national reimbursement levels, certain federal prices and certain federal and state rebate obligations. We have established systems for collecting and reporting this data accurately to CMS and have instituted a compliance program designed to assure that the information collected is complete in all respects. If we report pricing information that is not accurate to the federal government, we could be subject to fines and other sanctions (including potential FCA liability) that could adversely affect our business.
To market and sell our products outside of the United States, we must obtain and maintain regulatory approvals and comply with regulatory requirements in such jurisdictions. The approval procedures vary among countries in complexity and timing. We may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all, which would preclude us from commercializing products in those markets. In addition, some countries, particularly the countries of the European Union, regulate the pricing of prescription pharmaceuticals. In these countries, pricing discussions with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost effectiveness of our product candidate to other available therapies. Such trials may be time consuming and expensive and may not show an advantage in efficacy for our products. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, in either the United States or the European Union, we could be adversely affected.
In the United States, under the federal Physician Payment Sunshine Act or Open Payments Program (the “PPS Act”), we are required to report and disclose payments or other transfers of value made to certain healthcare providers, including physicians, certain advanced practice providers such as physician assistants and nurse practitioners, and teaching hospitals. CMS publishes information from these reports on a publicly available website, including amounts transferred and healthcare provider identities. Under the PPS Act we are required to collect and report detailed information regarding certain financial relationships we have with covered healthcare providers. The PPS Act preempts certain state reporting laws, although we or our subsidiaries may also be required to report under certain state transparency laws that address circumstances not covered by the PPS Act, and some of these state laws are also ambiguous. We are also subject to foreign regulations requiring transparency of certain interactions between suppliers and their customers. While we believe we have substantially compliant programs and controls in place to comply with these reporting requirements, we cannot assure you that regulations will not require us to take additional compliance steps. Our compliance with these rules imposes additional costs on us.
We also are subject to certain laws and regulations concerning the conduct of our foreign operations outside the United States, including the U.S. Foreign Corrupt Practices Act (“FCPA”) and other anti-bribery laws and related laws, and laws pertaining to the accuracy of our internal books and records, which have been the focus of increasing enforcement activity in recent years. Under the FCPA, the United States has increasingly focused on regulating the conduct by U.S. businesses occurring outside of the United States, generally prohibiting remuneration to foreign officials for the purpose of obtaining or retaining business. Also, in some countries we may rely on third parties for the marketing and distribution of our products, and these parties may lack sufficient internal compliance resources, and may operate in foreign markets involving substantial corruption. If our efforts to monitor these parties fail to detect potential wrongdoing, we could be held responsible for the noncompliance of these third parties with applicable laws and regulations, which may have a material adverse effect on our business.
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We could be adversely affected if other government or private third-party payors decrease or otherwise limit the amount, price, scope or other eligibility requirements for reimbursement for the purchasers of our products.
Certain of our products are subject to various cost-containment measures, such as government-imposed industry-wide price reductions, mandatory pricing systems, reference pricing systems, payors limiting access to treatments based on cost-benefit analyses, an increase in imports of drugs from lower-cost countries to higher-cost countries, shifting of the payment burden to patients through higher co-payments, limiting physicians’ ability to choose among competing medicines, mandatory substitution of generic drugs for the patented equivalent, and growing pressure on physicians to reduce the prescribing of patented prescription medicines. Such pressures could have a material adverse impact on our business, financial condition or results of operations, as well as on our reputation.
For example, certain pharmaceutical products, such as plasma derivative products, are subject to price controls in several of our principal markets, including Spain and countries within the European Union. In the United States, where pricing levels for our products are established by governmental payors and negotiated with private third-party payors, if the amount of reimbursement available for a product is reduced, it may cause groups or individuals dispensing the product to discontinue administration of the product, to administer lower doses, to substitute lower cost products or to seek additional price-related concessions. These actions could have a negative effect on our financial results, particularly in cases where our products command a premium price in the marketplace or where changes in reimbursement induce a shift in the location of treatment. The existence of direct and indirect price controls and pressures over our products has affected, and may continue to materially adversely affect, our ability to maintain or increase gross margins. In addition, the growth of overall healthcare costs and certain weak economic and financial environment in certain countries where we do business, as well as increased scrutiny over pharmaceutical pricing practices, such as in the United States, all enhance these pricing pressures.
In the United States, pricing concerns have led to heightened scrutiny and ongoing governmental efforts to increase transparency around healthcare and pharmaceutical drugs costs. For example, pursuant to current CMS rules applicable to hospitals and group health plans, payers must disclose in-network provider negotiated rates (which include rates with device suppliers and manufacturers) and historical out-of-network allowed amounts for all covered items and services, including all prescription drugs. In addition, in May 2025, the United States government issued an executive order aiming to implement “most-favored-nation” pricing mechanics, which would limit the price of prescription drugs in the United States to prices in selected comparably developed nations. In July 2025, several pharmaceutical companies received letters from the U.S. government seeking commitments to advance such “most-favored-nation” drug pricing goals. States are also enacting a variety of transparency measures. The publication of our negotiated rates could impact our ability to independently negotiate sales contracts and rate agreements. In addition, uncertainty around ongoing price transparency proposals affects our ability to plan, as the proposals, if adopted, in whole or in part, could adversely affect our business.
An increasing number of states in the United States have also proposed or passed legislation that seeks to directly or indirectly regulate pharmaceutical drug pricing, such as by requiring drug manufacturers to provide advance notice of certain price increases, or to place a maximum price ceiling on pharmaceutical products purchased by state agencies. State laws regulating pharmaceutical drug pricing may cause us to experience additional pricing pressures on our affected products, and could adversely affect our business.
Also, the intended use of a drug product by a physician can affect pricing. Physicians frequently prescribe legally available therapies for uses that are not described in the product’s labeling and that differ from those tested in clinical studies and that are approved by the FDA or similar regulatory authorities in other countries. These off-label uses are common across medical specialties, and physicians may believe such off-label uses constitute the preferred treatment or treatment of last resort for many patients in varied circumstances. In the United States, many off-label uses of drug products may be reimbursed by Medicare and other third-party payors, generally based on the payors’ determination that the intended use is for a medically accepted indication, for example, based on studies published in peer-reviewed medical journals or information contained in drug compendia, such as the United States Pharmacopeia-National Formulary. However, companies have also faced sanctions under the FCA in connection with the promotion of off-label drug uses that induce claims for reimbursement under Medicare and other federal programs. If reimbursement for off-label uses of products, including IVIG, is reduced or eliminated by Medicare or other third-party payors, including those in the United States or the European Union, we could be adversely affected.
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Proposed federal and state legislation have targeted drug pricing, including, without limitation, direct negotiations with manufacturers over price, reimbursement and discounts. Plasma protein therapeutics have been excluded from certain aspects of the several legislations; however, there is a continuing risk that our products may be subject to new pricing restrictions.
We are subject to extensive government regulatory compliance and ethics oversight.
Our business is subject to extensive government regulation and oversight by the many countries in which we operate. We have enacted anticorruption, privacy, healthcare and corporate compliance policies and procedures that govern our business practices and those of our distributors and suppliers. These policies and procedures are effectuated through education, training and monitoring of our employees, distributors and suppliers. In addition, to enhance compliance with applicable healthcare laws and mitigate potential liability in the event of noncompliance, regulatory authorities, such as HHS’s Office of the Inspector General (“OIG”) of the United States, have recommended the adoption and implementation of a comprehensive healthcare compliance program that generally contains the elements of an effective compliance and ethics program described in Section 8B2.1 of the U.S. Sentencing Commission Guidelines Manual. Increasing numbers of U.S.-based pharmaceutical companies have such programs, and we have adopted U.S. healthcare compliance and ethics programs that generally incorporate the OIG’s recommendations. However, our adoption and enforcement of these various policies and procedures does not ensure that we will avoid investigation or the imposition of penalties by applicable government agencies.
Failure to comply with changing regulatory requirements could materially adversely affect our business.
We engage in various manufacturing, processing, marketing and sales activities pertaining to pharmaceutical products in a number of jurisdictions around the world. These activities subject us to several governmental regulations governing our global operations. The laws and regulations of the many jurisdictions that govern our business and operations are subject to varying and evolving interpretations that affect our ability to comply, and future changes, additions, and enforcement approaches, including in light of political changes. Changes with respect to the applicable laws and regulations may require us to update or revise our operations, services, marketing practices, and compliance programs and controls, and may impose additional and unforeseen costs on us, pose new or previously immaterial risks to us, or may otherwise have a material adverse effect on our business. There can be no assurance that current and future government regulations will not adversely affect our business, and we cannot predict new regulatory priorities, the form, content or timing of regulatory actions, and their impact on the health care industry and on our business and operations.
We are subject to extensive environmental, health and safety laws and regulations.
Our business involves the controlled use and the generation, handling, management, storage, treatment and disposal of hazardous substances, wastes and various biological compounds and chemicals. The risk of contamination or injury from these materials cannot be eliminated. If an accident, spill or release of any regulated chemicals, substances or wastes occurs, we could be held liable for resulting damages, including for investigation, remediation and monitoring of the contamination, including natural resource damages, the costs of which could be substantial. As owners and operators of real property, we could also be held liable for the presence of hazardous substances as a result of prior site uses or activities, without regard to fault or the legality of the original conduct that caused or contributed to the presence or release of such hazardous substance on, at, under or from our property. We are also subject to numerous environmental, health and workplace safety laws and regulations, including those governing laboratory procedures, exposure to blood-borne pathogens and the handling of biohazardous materials, chemicals and wastes.
Although we maintain workers’ compensation insurance to cover the costs and expenses that may be incurred due to injuries to our employees resulting from the use and handling of these materials, chemicals and wastes, this insurance may not provide adequate coverage against potential liabilities.
Additional or more stringent federal, state, local or foreign laws and regulations affecting our operations may be adopted in the future. We may incur substantial capital costs and operating expenses to comply with any of these laws or regulations and the terms and conditions of any permits required pursuant to such laws and regulations, including costs to install new or updated pollution control equipment, modify our operations or perform other corrective actions at our respective facilities. In addition, fines and penalties may be imposed for noncompliance with environmental and health and safety laws and regulations or for the failure to have or comply with the terms and conditions of required environmental permits.
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Unsuccessful management of sustainability (environmental, social and governance) matters could adversely affect our reputation and we may experience difficulties meeting the expectations of our stakeholders.
Companies are increasingly expected to behave in a responsible manner on a variety of sustainability matters by governmental and regulatory authorities, counterparties, customers, investors and the public. This context, driven in part by a rapidly changing regulatory framework in Europe, is raising new challenges and influencing strategic decisions. Evolving regulatory requirements are likely to result in increased costs and complexities of compliance to collect, measure and report ESG-related information and may expose us to additional regulatory, litigation and reputational risk. Political and geopolitical developments may also result in the amendment or rollback of certain rules, creating further uncertainty and compliance costs.
We have adopted a sustainability strategy; however, we may be unable to meet our sustainability or other strategic objectives efficiently, on time or at all. Statements regarding our ESG initiatives, goals and progress may be based on developing standards, evolving internal controls and assumptions that may change. We may also be unable to meet the criteria used by rating agencies in their sustainability assessments, which are increasingly used by institutional investors to inform investment decisions.
If we are unable to meet stakeholder expectations or the targets contained in our sustainability strategy, our reputation may be harmed, compliance or other costs may increase, and interest in subscribing to our securities and our ability to access debt and equity markets may decrease. In addition, increasing “anti-ESG” and “anti-DEI” initiatives in certain jurisdictions may result in additional scrutiny, investigations, enforcement actions or reputational harm.
Risks Relating to Our Shares and American Depositary Shares
If we discover material weaknesses or significant deficiencies in our internal control over financial reporting, it may adversely affect our ability to provide timely and reliable financial information and satisfy our reporting obligations under U.S. federal securities laws, which also could affect the market price of our American Depositary Shares or our ability to remain listed on NASDAQ.
Effective internal and disclosure controls are necessary for us to provide reliable financial reports and effectively prevent fraud and to operate successfully as a public company. If we cannot provide reliable financial reports or prevent fraud, our reputation and operating results would be harmed. A “significant deficiency” is a deficiency, or combination of deficiencies, in internal control over financial reporting that is less severe than a material weakness, yet important enough to merit attention of those responsible for oversight of our financial reporting. In addition, a “material weakness” is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis.
To the extent that any material weakness or significant deficiency exists in our internal control over financial reporting, such material weakness or significant deficiency may adversely affect our ability to provide timely and reliable financial information necessary for the conduct of our business and satisfaction of our reporting obligations under U.S. federal securities laws, which could affect our ability to remain listed on NASDAQ. Ineffective internal and disclosure controls could cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our American Depositary Shares, or ADSs, or the rating of our debt.
The Grifols Family may exercise significant influence over the conduct of our business.
The founders of the Company and their relatives (the “Grifols Family”) and Scranton Enterprises B.V. own, directly and indirectly, approximately 36% of our Class A shares. The Class A shares exercise 100% of the voting control of our Company. As a result, the Grifols Family and Scranton Enterprises B.V. may exercise significant influence over matters requiring shareholders’ approval, including, among other things, the election of our board of directors, dividend policy and certain fundamental corporate action, such as the issuance of bonds, a merger or a dissolution. Conflicts may arise between the interests of the principal shareholders and those of the other shareholders, and the principal shareholders may choose to resolve the conflict in a way that does not coincide with the interests of the other shareholders. See Item 7 of this Part I, “Major Shareholders and Related Party Transactions—Related Party Transactions.”
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The market price of our Class B ADSs on NASDAQ, as well as the market price of our Class A ADSs traded in over the counter markets, may be volatile.
The market price of our Class B ADSs and Class A ADSs may be volatile as a result of various factors, many of which are beyond our control. These factors include, but are not limited to, the following:
The market price of our Class B ADSs may be adversely affected by any of the preceding or other factors regardless of operations and financial condition. Since December 31, 2023, our Class B ADSs have traded as high as $10.85 per ADS on July 30, 2025 and as low as $6.05 per ADS on March 18, 2024. At market close on April 15, 2026, our Class B ADSs were traded for $8.69.
Techniques employed by short sellers or other market disruptors may drive down the market price of our shares, negatively impact our business operations and/or generate non-meritorious litigation.
Short selling is the practice of selling securities that a seller does not own but rather has borrowed from a third party with the intention of buying identical securities back at a later date to return to the lender. Short sellers seek to profit from a decline in the value of the securities between the sale of the borrowed securities and the purchase of the replacement securities, as short sellers hope to pay less in that purchase than they received in the sale. As it is in short sellers’ interest for the price of the securities to decline, certain short sellers publish, or arrange for the publication of, negative research reports and allegations regarding the relevant issuer and its business prospects in order to create negative market momentum and generate profits for themselves after selling a security short. These short attacks have, in the past, created downward pressure on the price of the relevant securities.
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We have been the subject of negative publicity by a short seller. For more information, see Item 5 of this Part I, “A. Operating Results—Factors Affecting Our Financial Condition and Results of Operations—Short Seller Reports” and Item 8 of this Part I, “Consolidated Statements and Other Financial Information—Legal Proceedings—Executive Committee of the CNMV.” It is not clear what long-term effect such negative publicity could have on us and/or whether we will continue to be subject to short seller attacks from time to time in the future. If we were to become the subject of any additional unfavorable allegations, even when such allegations are untrue, we may have to expend a significant amount of resources to investigate such allegations and/or defend ourselves. For example, in response to such negative publicity, we invested significant resources and time, including undertaking both internal and external reviews. While we would prefer to strongly defend against any such short seller attacks, we may be constrained in the manner in which we can respond to any allegations due to applicable state or federal law, or issues of commercial confidentiality. In addition, such allegations have led, and may further lead, to heightened scrutiny, investigations and enforcement proceedings conducted by the SEC or the CNMV. Any future response to negative publicity from short sellers or responses to information requests from regulators could be costly and time-consuming, and could divert management’s attention from our day-to-day operations.
Even groundless or outright false allegations against us could severely impact the market price of our Class A shares, Class B shares, ADSs and our business operations. Because of the nature of our business in collecting plasma and manufacturing and selling plasma-derived therapies, we depend significantly on our brand and on customer confidence in our services. As a result, such allegations may impact our revenues by damaging our reputation, confidence in our services and relationships with our existing customers and potential new customers.
In the event that any lawsuit is filed against us as a result of negative publicity by a short seller, we cannot predict the timing, outcome or consequences of such actions, and we cannot assure you that our defenses will be successful or whether we will be subject to any damages, or how much. Whether or not we prevail in case any such proceedings are created against us, we may incur significant expenses defending them, which may materially and adversely affect our financial condition and results of operations.
Fluctuations in the exchange rate between the U.S. dollar and the euro may increase the risk of holding our ADSs or shares.
The Spanish securities market for equity securities consists of four stock exchanges located in Madrid, Barcelona, Bilbao and Valencia (collectively, the “Spanish Stock Exchanges”). The majority of the transactions conducted on the Spanish Stock Exchanges are done through the Spanish Automated Quotation System (Sistema de Inteconexión Bursátil Español, or SIBE).
Our Class A shares and Class B shares are listed on the Spanish Stock Exchanges and quoted on SIBE in euros. In addition, our Class B shares are traded in the United States on the NASDAQ Global Select Market in the form of ADSs, evidenced by American Depositary Receipts, or ADRs, in U.S. dollars. In addition, a number of our Class A shares are traded over the counter in the form of ADSs. Fluctuations in the exchange rate between the U.S. dollar and the euro may result in temporary differences between the value of our ADSs and the value of our shares, which may result in heavy trading by investors seeking to exploit such differences. This may increase the volatility of, and have an adverse effect on, the price of our shares or ADSs.
In addition, as a result of fluctuations in the exchange rate between the U.S. dollar and the euro, the U.S. dollar equivalent of the proceeds that a holder of our ADSs would receive upon the sale in Spain of any shares withdrawn from the ADR depositary and the U.S. dollar equivalent of any cash dividends paid in euros on our shares represented by the ADSs could also decline.
Subscription (or preemptive) rights may be unavailable to U.S. holders of our shares or ADSs.
In the case of a future increase of our registered share capital, existing shareholders will generally be entitled to subscription (or preemptive) rights pursuant to Spanish law, unless waived by a resolution of the shareholders or, if such power has been delegated to the Board pursuant to a shareholders’ resolution, by a resolution of the Board and except in certain situations, such as capital increases made for an in-kind contribution, in which subscription (or preemptive) rights are not applicable by law. Holders of the Class B shares will generally not have a right to vote on any resolution on a capital increase or on the waiver of subscription (or preemptive) rights, unless such resolution does not treat the Class B shares in the same way as the Class A shares, except in the limited circumstances set out in the Articles of Association of Grifols, S.A. as amended (the “Articles of Association”).
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Holders of our ADSs representing Class A shares or, even if preemptive rights are granted, holders of our ADSs representing Class B shares, or U.S. resident shareholders may not be able to exercise voting power or subscription (or preemptive) rights, as the case may be, in which case holders of our ADSs could be substantially diluted, unless a registration statement under the Securities Act, as amended, or the Securities Act, is effective with respect to such rights and the shares for which they give such right or an exemption from the registration requirements of the Securities Act is available.
We intend to evaluate at the time of any rights offering the costs and potential liabilities associated with any such registration requirements, as well as the benefits of enabling the exercise of subscription (or preemptive) rights for the shares. In doing so, we will also evaluate any other factors that we may consider appropriate at the time.
There can be no assurance that we will decide to comply with such registration requirements. If no such registration requirements are satisfied, the depositary will sell the subscription (or preemptive) rights relating to the ADSs on deposit and will distribute the proceeds of such sale, if any, to the holders of the ADSs. If the depositary is unable to sell rights that are not exercised or not distributed or if the sale is not lawful or reasonably practicable, it will allow the rights to lapse, in which case no value will be given for these rights.
ADS holders may be subject to limitations on the transfer of their ADSs.
ADSs are transferable on the books of the depositary. However, the depositary may refuse to deliver, transfer or register transfers of ADSs generally when the books of the depositary are closed or if such action is deemed necessary or advisable by the depositary or by us because of any requirement of law or of any government or governmental body or commission or under any provision of the deposit agreement. Moreover, the surrender of ADSs and withdrawal of our shares may be suspended subject to the payment of fees, taxes and similar charges or if we direct the depositary at any time to cease new issuances and withdrawals of our shares during periods specified by us in connection with shareholders’ meetings, the payment of dividends or as otherwise reasonably necessary for compliance with any applicable laws or government regulations.
Introduction
We were founded in 1940 in Barcelona, Spain by Dr. José Antonio Grifols i Roig, a specialist and pioneer in blood transfusions and clinical analysis and the grandfather of our current Honorary Chairperson (non-member) of the Board. We have been making and selling plasma derivative products for more than 70 years. Over the last 25 years, we have grown from a predominantly domestic Spanish company into a global company by expanding both organically and through acquisitions throughout Europe, the United States, Latin America, Africa and Asia.
We were incorporated in Spain as a limited liability company on June 22, 1987 under the name Grupo Grifols, S.A., and we changed our name to Grifols, S.A. in 2005. We conduct business under the commercial name “Grifols.” Our registered and principal executive office is located at Avinguda de la Generalitat, 152 Parque Empresarial Can Sant Joan, 08174 Sant Cugat del Vallès, Barcelona, Spain and our telephone number is +34 93 571 0500. Additional information about the Company is available on our website at www.grifols.com.
We are a vertically integrated global producer of plasma derivatives and we believe we rank among the three largest producers in the industry in terms of total sales globally. Our activities include sourcing raw material, manufacturing various plasma derivative products and selling and distributing final products to healthcare providers. We have expanded our plasma collection network and our manufacturing capacity through a combination of organic growth and acquisitions. As of December 31, 2025 we had more than 400 operating plasma collection centers located across the United States, Germany, Austria, Czech Republic, Hungary, Canada and Egypt (through our joint venture with Egypt’s National Services Projects Organization, or “NSPO”).
We also research, develop, manufacture and market in vitro diagnostics products, including analytical instruments, reagents, software and associated products for use in clinical and blood bank laboratories and hospital products.
Our Class A shares have been listed on the Spanish Stock Exchanges since we completed our initial public offering on May 17, 2006 and are quoted on the SIBE under the ticker symbol “GRF.” Since January 2008, we have been part of the IBEX-35 Index, which comprises the top 35 listed Spanish companies by liquidity and market capitalization. Our Class A shares are also traded in the United States in over the counter markets in the form of ADSs, evidenced by ADRs. Each ADS traded over the counter represents two of our Class A shares. Our Class B shares were issued as part of the consideration for the acquisition of Talecris Plasma Resources, Inc. (“Talecris”), a company that has since been merged into our subsidiary Biomat USA, and are listed on the Spanish Stock Exchanges and quoted on the SIBE under the ticker symbol “GRF.P.” Our Class B shares are also traded in the United States on the NASDAQ Global Select Market in the form of ADSs, evidenced by ADRs, under the symbol “GRFS.” Each ADS traded on NASDAQ represents one of our Class B shares. Our ADSs are currently traded in U.S. dollars. In November 2011, our ADSs were added to the NASDAQ Biotechnology Index.
The SEC maintains an internet site at http://www.sec.gov that contains reports, information statements and other information regarding issuers that file electronically with the SEC.
Important Milestones
The following are some of our most important historical milestones:
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For further details of material changes in our operations, products and services, see Item 5 of this Part I, “Operating and Financial Review and Prospects—A. Operating Results—Factors Affecting Our Financial Condition and Results of Operations” and Item 6 of this Part I “Directors and Senior Management.” For further details of our principal capital expenditures and divestitures, see Item 5 of this Part I, “Operating and Financial Review and Prospects—B. Liquidity and Capital Resources—Capital Expenditures, Other Intangible Assets and Rights of Use.”
General
We are one of the leading global specialty plasma therapeutics companies developing, manufacturing and distributing a broad range of biological medicines based on plasma derived proteins. Plasma derivatives are proteins found in human plasma, which once isolated and purified, have therapeutic value. These protein-based therapies extend and enhance the lives of individuals who suffer from chronic and acute, often life-threatening, conditions, including primary and secondary immunological deficiencies, Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”), A1PI deficiency and related emphysema, immune-mediated ITP, Guillain Barré syndrome, Kawasaki disease, allogeneic bone marrow transplants, hemophilia A and B, Von Willebrand Disease, traumatic or hemorrhagic shock and severe burns. In addition, we have built a diagnostic business that focuses on researching, developing, manufacturing and marketing in vitro diagnostics products for use in clinical and blood bank laboratories. We also specialize in providing infusion solutions, nutrition products and medical devices for use in hospitals and clinics.
Our products and services are used by healthcare providers in over 100 countries to diagnose and treat patients with hemophilia, immune deficiencies, infectious diseases and a range of other medical conditions, and we have a direct presence, through the operation of commercial subsidiaries, in over 30 countries.
We are a leading producer in the industry in terms of total sales globally. We believe we have a top three market position in various segments of the plasma derivatives industry, including A1PI, IG and albumin as well as in terms of plasma collection centers and fractionation capacity. Our long-term aim is to further strengthen our leadership through the development of new and differentiated plasma-derived therapeutics, and the expansion of our global plasma collection footprint via acquisitions and greenfield projects.
We organize our business into five business units: Plasma Procurement, Biopharma, Diagnostic, Bio Supplies and Others.
Plasma Procurement. The Plasma Procurement business unit includes all activities relating to plasma collection, including the evaluation and screening of plasma donors and the operation of our plasma collection centers. We report no revenue from the Plasma Procurement business unit because all plasma collected in our facilities is sold to Grifols companies in the Biopharma business unit and the revenue from these intra-group sales is offset against the intra-group expenses related to such sale upon consolidation, ensuring that only external revenue is reflected in our financial information. Due to the internal-facing nature of its operations, we describe our Plasma Procurement operations under the Biopharma unit in this annual report on Form 20-F.
Biopharma (formerly Bioscience). The Biopharma business unit includes activities relating to the manufacture of plasma derivatives for therapeutic use, including the reception, analysis, quarantine, classification, fractionation and purification of plasma and the sale and distribution of end products. The main plasma products we manufacture are IG, Factor VIII, Alpha 1 (A1PI) and albumin. We also manufacture intramuscular (hyperimmune) immunoglobulins, ATIII, Factor IX and plasma thromboplastin component (“PTC”). The Biopharma business unit accounted for €6.5 billion, or 86.2%, of our total net revenue in 2025.
Diagnostic. The Diagnostic business unit focuses on researching, developing, manufacturing and marketing in vitro diagnostics products, including analytical instruments, reagents, software and associated products for use in clinical and blood bank laboratories, covering the entire value chain from donation to transfusion. We concentrate our Diagnostic business in transfusion medicine (immunology, immunohematology) and specialty diagnostics such as hemostasis. The Diagnostic business unit’s main customers are blood donation centers, clinical analysis laboratories and hospital immunohematology services. The Nucleic Acid Testing, or NAT, Donor Screening Unit is engaged in research, development, manufacturing and commercialization of assays and instruments based on NAT technology for transfusion and transplantation screening. NAT technology makes it possible to detect the presence of infectious agents in blood and plasma donations, contributing to greater transfusion safety. The Diagnostic business unit accounted for €640 million, or 8.5%, of our total net revenue in 2025.
Bio Supplies. Net revenue from Bio Supplies primarily consists of revenue related to biological products for non-therapeutic use and plasma sales to third parties. The Bio Supplies business unit accounted for €154 million, or 2.0%, of our total net revenue in 2025.
Other Activities and Operations. In addition to our four business units, we have other smaller operations, activities and business lines (“Others”), which revenue primarily originates from the provision of manufacturing services to third parties, third party plasma sales and research activities. Others also includes our Healthcare Solutions (formerly our Hospital Division). This business unit includes, in addition, pharmaceutical products manufactured by the Group and intended for hospital pharmacies, as well as the marketing of products that complement our own products. Others accounted for €243 million, or 3.2%, of our total net revenue in 2025.
Geographic Markets
We believe we are a leading plasma derivatives producer globally, ranking among the three largest producers in the industry in terms of total sales, along with Takeda and CSL Group. We are the world’s largest producer of A1PI, which is used for the treatment of A1PI deficiency-related emphysema.
We currently operate in over 100 countries through distributors and subsidiaries in over 30 countries. The United States is the largest sales region in the world for the plasma derivative sector. For the year ended December 31, 2025, the United States and Canada accounted for 56.5% of our total net revenue, the European Union accounted for 21.5% of our total net revenues (25.9% of which was generated in Spain) and the rest of the world accounted for 22.0% of our total net revenue.
Certain sales regions, particularly in emerging markets, have experienced continuous growth, driven by enhanced socioeconomic conditions, including a general increase in the testing of patients for immunodeficiencies, autoimmune diseases and low levels of alpha 1 protein, all conditions treatable by our products, more informed patients who are demanding better quality medical care, as well as increasing government healthcare spending on plasma derivative products. These emerging markets are expected to experience significant growth. Our presence and experience in Latin America, in countries such as Mexico, Colombia, Argentina, Chile and Brazil, where we have been marketing and selling products for over 20 years, has positioned us to benefit from this additional growth in both our Biopharma and Diagnostic business units. In the Asia-Pacific region, we have established a presence through our subsidiaries and representative offices in Malaysia, China, Thailand, Singapore, Australia, Japan, India, Hong Kong, Taiwan and Indonesia. We have also opened a Middle Eastern representative office in Dubai and Saudi Arabia.
We maintain a continuing focus on international expansion and acquisitions and will continue to selectively consider acquisitions that would generate operation synergies. For specific examples of acquisitions we have made to further enhance our operations, see “—A. History and Development of the Company—Important Milestones” above.
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The following chart reflects a summary of net revenue by each of our geographic regions for the past three years:
Year ended
December 31,
% of total
Summary of Net Revenue by Region
net revenue
(in millions of euros, except for percentages)
European Union(1)(2)
1,614
21.5
1,499
20.8
1,256
19.1
United States and Canada
4,253
56.5
4,087
56.7
3,899
59.1
Rest of the World(2)
1,657
22.0
1,626
22.5
1,437
21.8
Total
100.0
Principal Activities
We organize our business into five business units: Plasma Procurement, Biopharma, Diagnostic, Bio Supplies and Others. The Plasma Procurement business unit generates no revenues, as all plasma collected is sold to Grifols companies in the Biopharma business unit, and does not represent a distinct source of risks and returns as its activities are fully integrated within the Biopharma value chain. As a result, our presentation of consolidated financial information excludes Plasma Procurement as an operating segment. The following chart presents our total net revenues by each of our other business units for the past three years:
Summary of Net Revenue by business unit
Biopharma
6,487
86.2
6,143
85.2
5,558
84.3
Diagnostic
640
8.5
645
8.9
670
10.2
Bio Supplies
154
2.0
216
3.0
2.4
Others
243
3.3
208
2.9
3.1
The Biopharma Business Unit
The Biopharma business unit is responsible for the research and development, production and marketing of plasma derivative products. In 2025, the Biopharma business unit accounted for 86.2% of our total net revenue.
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Operational Structure
The following chart illustrates its operational structure:
From plasma donation to therapeutic application, there are four major steps in the industry value chain process: (i) plasma collection, (ii) transport and logistics, (iii) manufacturing (fractionation and purification) and (iv) marketing and distribution. We are present at all levels of the value chain, from collection centers to distribution of the final products. This vertical integration enables us to leverage our position at each stage to control the overall process, to benefit from lower prices and to introduce complementary products, such as those offered through the Bio Supplies and Diagnostics business units, to our customers.
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Plasma Procurement
Plasma is the key raw material used in the production of plasma-derived products. We have expanded our plasma collection network through a combination of organic growth by opening new plasma collection centers and acquisitions. We obtain our plasma primarily from the United States and Europe (Germany, Austria, Czech Republic, and Hungary) through more than 400 operating plasma collection centers (310 in the U.S., 97 in Europe, and 8 in the rest of the world) and, to a much lesser extent, through agreements with third parties. Over the last few years, pursuant to the implementation of our business strategy, we have acquired plasma collection centers in the United States, Canada and Europe.
In 2025, we continued to manage our plasma supply efficiently, maintaining stability in cost per liter. This performance was supported by improved operational yields at donation centers, driven by the implementation in recent years of more efficient plasmapheresis equipment based on nomogram technology, which has increased process productivity. We also continued to optimize cost per liter of plasma collected through various initiatives aimed at streamlining structural costs, optimizing donor compensation, improving the donor experience, and increasing operational efficiencies across the entire center network. See “—Raw Materials” below and Item 5 of this Part I, “A. Operating Results—Factors Affecting our Financial Condition and Results of Operations—Operational Improvement Plan.”
We believe that the majority of our plasma requirements through 2026 will be met through plasma collected at our plasma collection centers and, to a lesser extent, purchased from third-party suppliers pursuant to various plasma purchase agreements. As we source the majority of our plasma internally, we are well positioned to ensure the availability of plasma for our manufacturing needs and assure the quality of the plasma throughout our manufacturing process.
We have implemented mechanisms to ensure that plasma donors meet the guidelines set forth by applicable regulations regarding, among other things, health, age and frequency of donations. Once the plasma donation is completed, as required by applicable regulations, we test every donation for pathogens such as HIV, hepatitis A, B and C, and parvovirus B19. If we discover a unit of plasma that cannot be used in the fractionation process, we notify the donor and remove all plasma previously donated by such donor from our inventory.
We describe our Plasma Procurement operations under the Biopharma unit in this annual report on Form 20-F because plasma collection is a fundamental part of our vertically integrated value chain. Rather than portraying plasma procurement as a standalone business, we integrate it into the Biopharma business unit’s description to reflect its primary role in securing raw materials for our plasma-derived therapies. This approach aligns with the industry practice of linking upstream supply chain activities to the core biopharmaceutical operations that generate end-products for commercialization. We believe that by consolidating the description of plasma procurement within Biopharma, we provide a clearer picture of how plasma sourcing directly supports revenue generation, cost efficiency and strategic decision-making, while also ensuring consistency in segment reporting and financial disclosures.
Transport and Logistics
Once plasma has been collected, it is frozen at the collection center and sent to fractionation centers. One essential aspect of this process is the implementation of safety procedures to guarantee the quality and safety of the donated plasma. To ensure preservation of the proteins found in plasma, plasma must be kept at or below a temperature of -20 degrees Celsius (-4 degrees Fahrenheit). In accordance with European and United States requirements, we store our plasma at a temperature of -30 degrees Celsius (-22 degrees Fahrenheit). During transportation, plasma is kept at a temperature at or below -20 degrees Celsius. Our frozen plasma is transported by two major transport companies, each supported by a network of logistic companies.
In the year ended December 31, 2025, we continued to see positive results from the initiatives related to our Operational Improvement Plan to optimize our supply chain and distribution logistics. These initiatives included maximizing available space in transport containers, increasing the amount of plasma transported per container by 7.0%, therefore reducing total transport figures. Other measures included optimizing the frequency of plasma collection routes in European workplaces, promoting full truckloads between plasma collection points, warehouses and the Barcelona manufacturing complex and using larger U.S. pallets to optimize storage and transport.
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Fractionation and Purification
Once plasma has been obtained, it may be used for plasma transfusions. It may also be frozen (as fresh frozen plasma) and manufactured into plasma derivatives through the fractionation process. The fractionation process consists of the separation of specific proteins through temperature and pH changes, as well as the use of filtration and centrifugation techniques. Fractionation occurs in tanks at near freezing temperatures to maintain the integrity of the proteins. All known plasma derivative products can be fractionated from the same batch of plasma. As a result, the development of a new or higher yield plasma derivative product would likely generate incremental sales without increasing the requirement for additional plasma.
We currently operate two Biopharma manufacturing facilities in the United States (Clayton, North Carolina, and Los Angeles, California), one in Spain (Parets del Vallès), one in Ireland (Dublin), one in Canada (Montreal) and one in Germany (Dreieich). Our plasma derivative products are manufactured at our Clayton, Los Angeles and Parets facilities. Our Clayton facility is one of the world’s largest integrated protein manufacturing sites, including fractionation, purification and aseptic filling and finishing of plasma-derived proteins. In 2025, we began construction of a new plasma-fractionation plant in Lliçà de Vall (Barcelona, Spain) with the goal of doubling our fractionation capacity in Europe. See “—D. Property, Plant and Equipment.”
Currently, the Clayton, Los Angeles, Dreieich and Parets facilities are equipped and licensed to produce certain plasma derivative products for the United States, European and other markets. For example, we produce our Flebogamma DIF, Gamunex and Yimmugo IVIG products for all of our markets at the Clayton, Los Angeles and Parets facilities.
Through an agreement with Grifols Canada Plasma (formerly named Canadian Plasma Resources Corporation) we have the right to obtain plasma donated at collection centers owned by Grifols Canada Plasma. In November 2025, we acquired 50.1% of Grifols Canada Plasma. See Item 5 of this Part I, “A. Operating Results—Factors Affecting Our Financial Condition and Results of Operations—Recent Acquisitions—Canadian Plasma Resources Corporation.”
On July 29, 2022, we executed a 15-year renewable collaboration agreement with Canadian Blood Services (“CBS”), a non-profit organization in Canada that operates on a national basis within the Canadian healthcare system. CBS provides services to patients on behalf of all provincial and territorial governments of Canada except Quebec, safeguarding Canada’s national system to provide lifesaving therapies related to blood, plasma, stem cells, organs and tissues. By means of this agreement, we committed to supply an amount of IG to CBS equivalent to 25% (2.4 million grams) of the Canadian patient consumption needs (excluding Quebec). In addition to plasma collected at Grifols Canada Plasma’s centers, we fulfill this agreement with other plasma collected from a Canada-based plasma collection center network owned and managed by us, manufacturing our products in our facility in Montreal, Quebec (described below).
As part of the arrangements with CBS, we have access to a network of 17 plasma collection centers in Canada, 8 of which are wholly owned by us. For each liter of Canadian plasma we use to supply IG, we will also supply to CBS all remaining manufactured paste for the processing of other plasma-derived products.
In October 2020, we purchased from GC Pharma a plasma fractionation facility and two purification facilities located in Montreal, Canada (as well as 11 plasma collection centers located in the United States). Once we finish renovations and obtain all necessary licenses and regulatory approvals for these facilities, we will become the only large-scale commercial manufacturer of plasma products in Canada. In 2025, the first phase was completed with the commissioning of an albumin purification and filling plant, and we started manufacturing albumin in the Montreal facilities. Phases II and III, currently under development, include the addition of a plasma-fractionation plant and a second IVIG purification and filling facility. We expect to begin plasma fractionation and gammaglobulin manufacturing by 2027.
We also continually optimize utilization of our fractionation capacity by obtaining FDA and EMA licenses, and completing further requirements, that allow us to purify at any of our other facilities intermediate products that are produced at one of our facilities. We have obtained the following FDA licenses, among others:
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We are continuing our efforts to obtain additional FDA licenses of this nature. The flexibility provided through such licenses allows us to increase production efficiency and to better address changes in demand between the United States, the European Union and other world markets.
For more information on our manufacturing facilities, see “—D. Property, Plant and Equipment” below.
Safety
We have never experienced a mandatory recall of any batch of our finished biological products due to a safety risk. In alignment with our commitment to safety and quality, we have in the past voluntarily withdrawn some product lots as a precautionary measure due to a higher rate of allergic/hypersensitivity type reactions that we found to be isolated to a small subset of plasma donors. These withdrawals were conducted with the knowledge of the governmental authorities of the applicable jurisdictions. Our philosophy is that the health of the plasma donor and the patient are the paramount considerations. None of the withdrawn products involved reports of any significant impact on patients. We strongly believe that our safety philosophy is consistent with the business objective of generating profit. We also believe that we have a strong reputation for safety in our markets, thus making our products particularly attractive to customers. We further believe that our vertically integrated business model allows us to help assure the safety and quality of our plasma derivative products through the implementation of our safety standards.
The plasma collection, fractionation and purification process is long, complex and highly regulated. We have adopted and maintain rigorous safety standards that we believe exceed those required by health authorities in Europe and the United States. The Grifols Group is periodically inspected and certified for Good Manufacturing Practices (“GMP”) competent health authorities, such as European authorities, the FDA, and other relevant government authorities of other countries where our products are marketed. In 2025, we performed over 490 quality control supplier audits to ensure compliance with GMP.
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We maintain standards that we believe are consistent with other industry participants with regard to plasma safety and are periodically certified by the Plasma Protein Therapeutics Association (“PPTA”), under the International Quality Plasma Program (“IQPP”), for plasma donation centers, and under the Quality Standards of Excellence, Assurance and Leadership Program (“QSEAL”), for fractionation plants. For example, source plasma inventory is held for not less than 60 days after donation, to allow for retrieval and destruction of plasma units if the donor is disqualified during this period (after seroconversion or due to high-risk behavior or international travel). We have also introduced innovative methods such as the Plasma Bottle Sampling system, which automatically prepares, codes and labels test samples at the time of plasma donation, and the PediGri On Line system, designed to provide full traceability of human plasma raw material throughout the plasma supply chain. See “—Distribution Process” below. We conduct routine health screenings and medical evaluations before each donation, ensuring plasma donor health remains a priority.
Our manufacturing plants have been designed to comply with the current GMP standards and applicable regulations for clean areas, and are designed to minimize clean areas as well as human intervention, with the objective of lowering the risk of contamination. The facilities are subject to a cleaning and sanitizing plan and to a corrective and preventive maintenance program. Periodically, we voluntarily shut down all of our manufacturing facilities to perform maintenance work, expansion projects and other capital investments. Our manufacturing facilities have never been subject to mandatory shut down because of regulatory noncompliance while under our operation. We believe that our voluntary shutdown procedure lowers the risk of any mandatory shutdown.
We have processes in place to ensure that all of our plasma derived products are manufactured strictly following validated and approved procedures, and in accordance with the corresponding marketing authorization. Also, each manufacturing process includes at least one validated specific virus inactivation or removal step as a precautionary measure to avoid improbable virus contamination.
Since our products are proteins that cannot be terminally sterilized, they therefore are sterilized by filtration before being aseptically filled in their final container. We have patented the Grifols Sterile Filling (“GSF”) system which minimizes the risk of microbial or particulate contamination during the aseptic filling process. During this process, sterilized containers are filled with the product under Grade A laminar air flow. The partially closed containers (vial with stopper and protector) are sterilized prior to filling. The container closure unit remains partially closed until the moment of filling, after which it is immediately sealed thus reducing the risk of contamination by reducing the product and container exposure to the controlled environment. The filling process is recorded, which enables us to identify the cause of, and rectify more easily, any related problem. These records are maintained according to our data retention policy.
Once aseptically filled, each unit of product is laser-marked with the objective of individually identifying each container and preventing and detecting counterfeits. This allows us to protect the integrity of our manufacturing process.
After plasma derivatives are manufactured, every unit of each lot is visually inspected in order to detect the presence of foreign particles or other imperfections in the container closure system. Each lot is also tested during production and at the end of the manufacturing process according to the licensed specifications, marketing authorization and corresponding Pharmacopoeia monographs. All processes are overseen by the quality systems in place at Grifols with the objective of ensuring that products are marketed with the appropriate quality, purity, potency and safety.
Finally, once the product is marketed, our pharmacovigilance system allows us to control all potential adverse reactions resulting from the administration of our products, and our surveillance system tracks adverse incidents due to the use of medical devices and in vitro diagnostic, thus ensuring the safety of our products around the world.
We continually invest in the improvement of our manufacturing facilities and plasma fractionation process, as well as in other related systems, in order to ensure the quality and safety of our products.
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Distribution Process
With each batch of plasma derivatives, we deliver electronic information regarding the origin, characteristics and controls of each of the units of plasma that we use in the preparation of the batch to our customers. This feature, called the PediGri On Line system, allows healthcare users of our products and regulatory authorities to have immediate and easy access to this information, tangible proof of the full traceability of our products. We have had this system in place since 1996, and we believe we are the only fractionator that provides this feature to customers.
We have our own sales and distribution networks covering substantially all of our markets, staffed with highly trained personnel. A majority of our sales in 2025 were made through our own distribution network, which is experienced in the proper handling of our products. We believe that this network provides for greater safety because it allows us to track our products and react quickly in the case of a potential product recall. In countries where we do not have our own distribution network, we use carefully selected distributors who are required to follow all of our safety standards.
For further information, see “—Marketing and Distribution” below.
Biopharma Products and Services
Collected plasma, whether source or recovered, is fractionated into different component proteins. We fractionate and purify a broad range of plasma derivative products that improve patient care. Our Biopharma business unit also sells a non-plasma derivative medicinal product, Tavlesse (fostamatinib), in Europe.
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The chart below presents our principal products by brand name and their respective therapeutic indications:
Product Description
Main Therapeutic Indications
Gamunex/Gamunex-C. Immune Globulin Injection (Human), 10% Caprylate/Chomatography Purified. Flebogamma 5% and 10% DIF. Immune Globulin Intravenous (Human).
Globally, IVIG is used for the treatment of: primary and secondary immunological deficiencies and autoimmune conditions including immune-mediated ITP; Measles pre/post exposure prophylaxis in patients to whom active immunization is contraindicated or not advised; Guillain Barré syndrome; Kawasaki disease; chronic inflammatory demyelinating polyneuropathy (“CIDP”); and multifocal motor neuropathy (“MMN”). Severe acute myasthenia exacerbations is an approved indication for Gamunex-C in Europe.
Xembify. Immune Globulin Subcutaneous (Human) - klhw 20% solution.
In the United States, it is used to treat Primary Humoral Immunodeficiency (“PI”). In Europe and Australia, Xembify is also indicated to treat hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (“CLL”) in whom prophylactic antibiotics have failed or are contra-indicated, hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (“MM”) patients, and hypogammaglobulinaemia in patients pre- and post- allogeneic haematopoietic stem cell transplantation (“HSCT”).
HyperRAB Rabies Immune Globulin (Human).
Anti-rabies immunoglobulin indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies who have not been previously vaccinated with a rabies vaccine and have a confirmed adequate rabies antibody titer.
Prolastin/Prolastin-C/ Prolastin-C Liquid/Prolasplan/ Prolastina/Pulmolast/Lynspad. Alpha 1-Proteinase Inhibitor (Human).
Used to treat adults with clinical evidence of emphysema due to severe hereditary alpha-1 antitrypsin deficiency (“A1PI deficiency”).
Fanhdi and Alphanate. Antihemophilic Factor/von Willebrand Factor Complex (Human).
Used for the prevention, management and control of bleeding in Factor VIII deficiency (hemophilia A) and indication for Von Willebrand Disease.
Koate-DVI. Antihemophilic Factor (Human).
Used for the prevention and control of bleeding in Factor VIII deficiency (hemophilia A).
Albutein/ Albutein FlexBag / Human Albumin Grifols/Plasbumin. Albumin (Human) 5%, 20% and 25%.
Used to re-establish and maintain circulation volume in the treatment of hypovolemia (i.e., traumatic or hemorrhagic shock, septic shock and severe burns) and to treat complications related to Cirrhosis.
Vistaseal/VeraSeal. Human fibrinogen/human thrombin.
Used as a supplemental treatment in adults where standard surgical techniques are insufficient for improvement of haemostasis, and as suture support in vascular surgery.
Tavlesse. Fostamatinib Disodium Hexahydrate Film Coated Tablets.
Used for the treatment of chronic immune thrombocytopenia (“ITP”) in adult patients who are refractory to other treatments.
Intravenous immunoglobulin (IVIG)
Gamunex-C IVIG, a ready-to-use liquid IVIG product, is one of the leading products in the IVIG segment. We believe Gamunex-C IVIG is one of the premium products in its category since its launch due to a comprehensive set of differentiated product characteristics. We are one of the market leaders in the production and marketing of immunoglobulin, with 26.0% market share in volume in the United States for the twelve-month period ended September 30, 2025, according to PPTA.
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Subcutaneous Immunoglobulin (“SCIG”)
Xembify, our 20% SCIG, was first launched in the United States in 2019, with the indication for treatment of primary immunodeficiencies. In 2024, the FDA approved a label expansion that allows patients who are IG treatment-naïve (meaning, who have never received a certain drug or therapy for a specific condition) to start SCIG therapy with Xembify without having to first go through IVIG therapy, making Xembify the first 20% SCIG product in the United States with such indication. This FDA approval also included new biweekly dosing (as opposed to the prior weekly dosage) enhancing flexibility and convenience for patients. Xembify is also approved for use in both primary and secondary immunodeficiencies in Canada and several countries in the European Union. We launched Xembify in eleven additional countries between 2023 and 2025 (Spain and Australia in 2023, followed by Norway, Sweden, France, Czech Republic, Slovakia, Iceland, Finland, the United Kingdom in 2024 and Italy in 2025).
In 2025, we continued the Phase III clinical trial program evaluating the safety, efficacy and pharmacokinetics of Xembify in the prevention of infections in patients with chronic lymphocytic leukemia (CLC), multiple myeloma (MM) and Hodgkin lymphoma (HL) with secondary immunodeficiency (SID).
Human Rabies Immunoglobulin (“HRIG”)
We believe HyperRAB is the world’s leading HRIG indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies who have not been previously vaccinated with rabies vaccine. HyperRAB, a 300 IU/ml formulation of which is available in the United States, is the only HRIG provided as a higher-potency formulation, potentially requiring fewer injections in administration of each dose. We had an estimated 87.0% market share in sales of anti-rabies immunoglobulins in the United States as of December 2025.
Alpha-1-Antitrypsin Augmentation Therapy (AAT)
We believe that we are the global market leader in the sales of AAT products. On December 31, 2025, our AAT products had 76 licenses in 29 countries worldwide, 56 of which are located in North America and Europe. Based on our estimations we had more than a 69.0% global sales market share for AAT as of December 2024. Our main brand for AAT products is Prolastin, a chronic augmentation and maintenance therapy to treat emphysema related to severe hereditary A1PI deficiency. We sell the freeze-dried powder formulation of Prolastin primarily in North and South America and Europe. Between 2024 and 2025, we launched new 4- and 5-gram vial sizes for this formulation of Prolastin in a number of countries in Europe, including Germany, Denmark, France, Austria, Spain, Portugal and Italy. In addition, our ready-to-use liquid formulation of AAT (Prolastin-C Liquid) is FDA-approved and sold in the United States. We are currently conducting a worldwide clinical trial (SPARTA) to meet post-approval regulatory commitments and obtain regulatory approval for Prolastin-C Liquid in Europe. In 2024, we sponsored over 150,000 genetic tests to rapidly accelerate patient diagnosis.
Hemophilia A
Between Koate-DVI, Fanhdi and Alphanate, all products to control bleeding in hemophilia A patients, we had an estimated 13.8% market share based on volume globally in the pdFVIII hemophilia A market in 2024 (excluding Von Willebrand Disease use).
Albumin
We have several albumin-based products, primarily under our Albutein brand. We sell our albumin-based products globally, with an estimated 17.6 % market share in sales volume in 2025. Our albumin products meet U.S., European and Chinese requirements, making them attractive to biotechnology companies and genetic labs, as well as hospitals and physicians. In 2021 and 2022, we launched and began to market in the United States Albutein 25% and 5% FlexBag, a flexible container designed to add convenience, ease of use, and durability. In 2025, sales of Albutein 25% and 5% FlexBag in the United States represented 19.0% of the total Albutein brand sales (as compared to 15.0% in 2024).
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Chronic Immune Thrombocytopenia (ITP)
Tavlesse, the first oral therapy commercialized by Grifols Biopharma, is a novel SYK-inhibitor in-licensed from Rigel Pharmaceuticals for commercialization in Europe and additional markets in the Middle East and North Africa. Tavlesse is indicated to treat chronic immune thrombocytopenia in adult patients who are refractory to other treatments. In 2024, we launched Tavlesse in Slovakia and the United Arab Emirates and also sell the product in Czech Republic, Norway, Denmark, The Netherlands, Germany, Spain, Italy, France Poland, Finland, Ireland and the United Kingdom. In 2025, we expanded our Tavlesse sales into Saudi Arabia.
Other Products
We produce antithrombin products such as Anbinex and Thrombate III, which are used in the prevention and treatment of thromboembolic complications in patients with antithrombin deficiency; and AlphaNine, Profilnine and Factor IX Grifols, which are used in the prevention and control of bleeding in patients with hemophilia B.
We commercialize intramuscular (hyperimmune) immunoglobulins, which are used for the prevention and treatment of tetanus, prevention and treatment of hepatitis B, and Rh factor complications during birth. Niuliva and Igantibe are used after liver transplants to prevent hepatitis B reinfection of the graft.
We also manufacture Vistaseal/Veraseal, a biological fibrin sealant composed of fibrinogen and human thrombin used in surgical operations to expedite the healing process. This product is commercialized in the United States and Canada, in some European countries (i.e. Germany, United Kingdom, Switzerland, Estonia, Latvia, Lithuania, Austria, Ireland, Netherlands, France and Italy) as well as in South Korea, Taiwan, Singapore, Puerto Rico, Israel and Australia by Johnson & Johnson MedTech (a Johnson & Johnson company). In 2024, VistaSeal received approval to treat surgical bleeding in pediatric patients with its fibrin sealant solution in the United States, Canada and Australia.
To sell medicinal products, we must first register the products with the relevant authorities of the jurisdictions where the products are to be marketed and sold. To comply with the regulatory requirements in a given jurisdiction, we have a core team in Spain and the United States that prepares, files and coordinates the registration process with the technical personnel at the subsidiary assigned to that jurisdiction. As of December 31, 2025, we had 1,117 Biopharma product licenses registered in 90 countries throughout Europe, the United States, Latin America, Asia and the rest of the world. As of December 31, 2025, our most significant government-issued licenses for Biopharma products are:
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In addition to the sale of products described above, we also support and collaborate with countries to increase their plasma self-sufficiency. The company leads this objective through the Grifols Self-Sufficiency Program. In parallel, its global industrial plasma fractionation programs contribute to reducing healthcare costs, promoting better and greater access to plasma treatments, and contributing to more sustainable healthcare systems. In Spain, we operate under a centralized plasma fractionation contract with the Spanish Ministry of Health. Under this framework, recovered and source plasma collected by Spanish transfusion centers are fractionated and further manufactured into plasma-derivatives products under our brand name for hospital use. We receive service fees from the applicable transfusion entities for the fractionation and manufacturing services provided under this arrangement. We also maintain similar arrangements with other public-sector counterparties, including in Italy (Emilia Romagna Region), and support self-sufficiency initiatives in Canada and Egypt through strategic collaboration agreements, including with Canadian Blood Services (CBS) and with the Egyptian government.
Furthermore, the product launches and regulatory approvals obtained during the year will continue strengthening the Biopharma portfolio and its competitive positioning. In the U.S, Yimmugo was launched following FDA approval. This next-generation intravenous immunoglobulin, developed and manufactured at Biotest’s facility in Germany and marketed in Europe since 2022, expands the Group’s immunoglobulin offering to meet growing market demand. Distribution in the U.S. is carried out through Kedrion Inc., and it is expected to contribute positively to the Group’s future growth.
Additionally, after obtaining the corresponding regulatory approvals, we began marketing Prufibry in Europe in 2025. This fibrinogen concentrate is indicated for the treatment of congenital (CFD) and acquired (AFD) fibrinogen deficiency. The launch began in Germany and was followed by Austria, with a progressive introduction planned across additional EU countries. We also obtained FDA approval for Fesilty, our fibrinogen concentrate indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency. Commercialization in the United States is expected in the first half of 2026, enabling us to strengthen our position in high-value specialized therapies.
The Diagnostic Business Unit
The Diagnostic business unit, which accounted for €640 million, or 8.5% of total net revenue in 2025, focuses on researching, developing, manufacturing and marketing in vitro diagnostics products, including analytical instruments, reagents, software and associated products for use in diagnostic clinical and blood bank laboratories.
On December 31, 2025, more than 97.0% of our in vitro diagnostics products, including, but not limited to, Gel cards, Reagent Red Blood Cells and Molecular Diagnostics assays, had received In Vitro Diagnostic Regulation (“IVDR”) certification. IVDR is the regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices in the European market. We are currently implementing all remaining requirements to obtain IVDR certification in a timely manner for all of our in vitro diagnostics products. Additionally, we have several approvals in other markets, including FDA approvals in the United States for the majority of our portfolio.
The main areas of specialization of this business unit are transfusion medicine and specialty diagnostics.
In transfusion medicine, we have a significant market share in NAT blood donor screening solutions. In addition, we have increased our sales in the Blood Typing segment with automated immunohematology systems and reagents to hospital transfusion services and blood centers in several key global markets. We also continue to grow our portfolio of specialty diagnostic products in selected areas, including autoimmunity and infectious diseases. Our principal diagnostic products are:
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Main Applications
Transfusion Medicine:
Procleix Panther systems/Procleix Panther with Automation Ready Technology (ART). Automated NAT blood screening systems, assays and software.
Used to detect infectious viruses and parasites in donated blood and plasma including: HIV (Types 1 & 2); Hepatitis A, Hepatitis B, Hepatitis C and Hepatitis E; parvovirus B19; Plasmodium, Babesia and Arbovirus like, Chikungunya, West Nile Virus, Dengue, Zika.
Wadiana/Erytra /Erytra Eflexis analyzers. Automated immunohematology analyzers that use gel agglutination technology to enable automatic processing of DG Gel system, including DG Gel cards, reagent red blood cells, antisera and associated software. Manual and semiautomated equipment are also part of the DG Gel system.
Used for routine pre-transfusion compatibility testing, including blood typing, unexpected antibody screening and identification, extended phenotype and cross-match tests, among others.
BLOODchip ID/ IDCoreXT/ IDHPAXT/ IDRHDXT / IDCORECONTROL / BIDSXT. A multiplex blood group genotyping family of products based on Luminex technology, including kits for the main allelic variants of red blood cells, human platelet antigens, a positive control for ID COREXT, and an accompanying software.
Used to help determine blood groups in individuals who may not be able to be typed with traditional blood grouping methods due to recent transfusions, autoantibodies, or other limitations.
Antigens. Critical component of certain infectious disease tests.
Used in the manufacture of clinical diagnostic and blood donor screening immunoassays.
Specialty Diagnostics:
Promonitor. Highly specific immunoassays for quantification of serum drug levels and anti-drug antibodies of various biological drugs.
Used to measure quantity of drug and antibodies for a number of biological drugs, commonly used in the treatment of various inflammatory diseases.
AlphaIDTM. Genetic test for patients for alpha-1 deficiency.
This is a free cheek swab to screen for alpha-1, the most common genetic form of Chronic Obstructive Pulmonary Disease (“COPD”).
We manufacture most of our gel cards and red blood cells and assemble our immunohematology analyzers at our Parets facility in Spain. We also manufacture gel cards in Australia and red blood cells in Switzerland. We manufacture antigens at our Emeryville facility in the United States, while oligos and other critical components of the transcription-mediated amplified NAT kits for blood and plasma infectious diseases screening are manufactured at our San Diego facility in the United States. We also started manufacturing gel cards and RRBCs in our San Diego facilities in 2025.
In several countries, we distribute BLOODchip blood group genotyping tests manufactured by our subsidiary Progenika Biopharma, S.A. (“Progenika”). This product line includes ID CORE XT, which determines 37 antigens of red blood cell groups, ID RHD XT, a molecular diagnostic kit that detects the most relevant RhD variations, HPA-1 and ID HPAXT kit to determine 12 Human Platelet Antigen (“HPA”) systems. BIDSXT is the software tool that allows the analysis, interpretation and database management to transmit the results to the Laboratory information system (“LIS”).
The production, marketing and sale of many of our Diagnostic business unit products are subject to the prior registration of such products with the relevant authorities of the applicable jurisdictions. As of December 31, 2025, we had 4,117 diagnostic product licenses registered in over 50 countries in Europe, the United States, Canada, Latin America, Asia-Pacific, Middle East and Africa. In addition to the products noted above, we offer our customers solutions developed in collaboration with, or manufactured by, third-parties that we believe complement our product lines.
Our Diagnostic business unit includes a complete line of products and systems to ensure compatibility between donors and patients for safe transfusion aimed at detecting the pathogenic agents of transfusion-related infectious diseases such as HIV (Types 1 & 2), Hepatitis A, Hepatitis B, Hepatitis C, Hepatitis E, parvovirus B19, Plasmodium, Babesia and Arboviruses such as Chikungunya, West Nile Virus, Dengue and Zika.
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Recent Efforts in Transfusion Medicine
As part of our strategy of geographic expansion, we continue to consider requests to include NAT screening for blood and plasma donations in countries as they develop their health systems. From 2020 to 2025, we entered several new countries, such as Guatemala, Paraguay, Czech Republic and Sweden. In recent years we have focused on obtaining FDA and other regulatory approvals to expand our portfolio. The following table summarizes such recent efforts:
Product Description and Main Applications
Licensing Update
Procleix Quality Controls, intended for use as an external assayed quality control material to monitor the performance of several assays performed on the Procleix Panther system.
FDA 510(k) clearance in 2022.
Procleix Plasmodium Assay, for use on the Procleix Panther System, in Brazil.
Approval in Brazil in 2023.
Through our U.S. subsidiaries Biomat USA and Grifols Bio Supplies, Inc (formerly named Interstate Blood Bank Inc.), we have entered into an agreement with Creative Testing Solutions (“CTS”), a nonprofit blood donor testing laboratory organization in the United States. Pursuant to this agreement, which was amended in 2025, CTS agreed to operate until 2045 (renewable for up to another ten years) our three testing laboratories located in Memphis, Tennessee and San Marcos and Austin, Texas, to perform donor screening for blood and plasma collections.
Grifols Laboratory Solutions will continue to provide specialty testing as well as diagnostic solutions for clinical issues related to Molecular and Serological Immunohematology. The facility in Austin, Texas, provides testing, consultation and integrated solutions to optimize patient care for specialists in Hematology, Oncology, Perinatology, Obstetrics, Pharmacy, Transplantation and Transfusion Medicine.
We operate a product line of high-quality antigens — including HIV and HCV antigens — that are critical components of immunoassay diagnostics and blood screening applications. Our joint business arrangement with Ortho (QuidelOrtho), initiated over 40 years ago, was originally focused on the development and production of HIV and HCV antigens by us and the profit-sharing of related assay sales by Ortho. As this market has matured over time, we agreed to terminate the arrangement effective January 1, 2026, pursuant to a Settlement and Termination Agreement executed on April 11, 2026. We agreed on a settlement amount of $65.0 million to be paid by QuidelOrtho to us as a final and comprehensive settlement of all matters arising from the termination, payable in three installments: $25.0 million in Q2 2026, $25.0 million in Q1 2027, and $15.0 million in Q1 2028. In connection with the termination, we entered into a new multi-year Exclusive Supply Agreement with Ortho under which we continue to manufacture and supply antigens to Ortho, as well as to third parties including Abbott Laboratories, Siemens and OraSure Technologies.
The table below summarizes our recent efforts to obtain more licenses and increase the market of our immunohematology products:
Immunohematology Product Description and Main Applications
Blood Typing Manager, designed to aid in the interfacing and managing of data among immunohematology instruments, blood establishment computer software and laboratory information systems as part of the DG Gel System.
CE mark in 2022; FDA 510(k) clearance in 2022; Approval in Brazil 2023.
Weak D Control, to ensure accurate validation of weak D results, supporting blood banks and donor centers in maintaining the highest standards of quality and compliance. By confirming agglutination, it verifies that RhD typing procedures are functioning correctly, reinforcing routine quality control processes. It is a dual-use weak positive control with a confirmed weak expression of the RhD antigen to be used in parallel with D typing tests either using DG Gel System or tube technique.
CE Mark in 2025.
Grifols sCD38, designed to counteract daratumumb-mediated pan-reactivity without significantly diluting the patients’ plasma and enables subsequent screening and identification of irregular antibodies in DG Gel system and tube techniques, and crossmatch in DG Gel system. Daratumumab is a CD38-directed monoclonal antibody for treating multiple myeloma. However, during treatment the drug binds to the CD38 protein on red blood cells and can alter the results of critical blood pre-transfusion tests. This can delay lifesaving transfusions for these patients.
CE mark in 2022. Approvals in Brazil, Vietnam and Singapore in 2025.
DG Gel 8 Direct Coombs card, used for the evaluation of the direct antiglobulin test of two different human blood samples. This product is designed to differentiate red blood cells sensitized in vivo by IgG type immunoglobulins or the complement C3d fractions. The card is intended to be used with the DG Gel System.
FDA approval in 2022.
The DG Gel DC Scan Plus, intended to be used in gel technique for the evaluation of the direct antiglobulin test. This test permits the differentiation of red blood cells sensitized in vivo by IgG, IgA and IgM type immunoglobulins and/or with the complement C3b, C3d and C4b fractions in human blood samples. The DG Gel DC Scan Plus card is intended for the investigation of clinical situations where the presence of hemolysis has been established, or is suspected, to distinguish immune from nonimmune hemolytic anemia. The card can be used manually or with automated instruments of the DG Gel System.
CE mark in 2022; Approval in Brazil 2023; Approval in Australia 2023. Approval in Mexico 2025.
Sero-Cyte Pool Dia 0.8%, designed for routine testing for the screening of irregular antibodies, including the antigen Dia, in donors. This reagent complements the existing reagent red blood cells and allows us to reinforce our presence in markets, such as Brazil, where the identification of the antigen Dia is required by local regulations.
CE mark in 2022; Approval in Brazil 2023.
DG Reader NET, a single card processing platform operating with the same consumables and reagents as our fully automated systems. This product is designed to be used on our DG Gel systems.
CE mark in 2016; FDA 510(k) clearance in 2018; Approval in China 2023.
Procleix Plasmodium Assay, an assay to detect ribonucleic acid (“RNA”) from Plasmodium species (P. falciparum, P. knowlesi, P. malariae, P. ovale, and P. vivax) in whole blood specimens that cause Malaria disease. The assay is designed to be used for routine screening by blood banks on the Procleix Panther system, where we estimate that we are currently the market leader and continue our efforts to offer innovative solutions to blood banks.
CE Mark in 2022.
DG Gel Neutral, is a gel card used for the detection of antibodies to red blood cell antigens and as a control microtube, supporting saline and enzymatic immunohematology techniques within the DG Gel System. DG GEL Rh Pheno is a gel card designed for the determination of Rh blood group antigens (C, E, c, and e) on red blood cells, enabling efficient and reliable Rh phenotyping using gel technology.
Registered in China in 2025.
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DG Gel Card, original 8-well gel cards based on column agglutination technology, used for blood group typing and investigation of unexpected antibodies, and compatible with manual, semi-automated, and fully automated DG Gel systems. Red-cell reagents (DG Gel system), standardized reagent red blood cells used with DG Gel cards to support blood typing, antibody screening, and antibody identification in column agglutination testing.
Obtained FDA license to manufacture at San Diego facility in 2025.
Data-Cyte Plus P 0.8%, our first papain-treated red-cell panel.
Obtained FDA license to manufacture in the U.S. in 2025.
In addition, in 2025, we entered into a strategic agreement with Inpeco, a global leader in laboratory automation solutions, pursuant to which we have the exclusive right to sell certain of Inpeco’s TLA automation technologies to transfusion medicine labs, aiming to modernize workflows and boost efficiency. The agreement also enables us to expand our diagnostic offering with scalable automation capabilities adaptable to laboratories of different sizes and evolving technological needs;
Specialty Diagnostics
We retain the first FDA-approved biological molecular test that uses the DNA of the patient for the diagnostic. This genetic test to detect alpha-1 antitrypsin deficiency (the “A1AT Genotyping Test”) can be conducted on DNA extracted from blood as well as a drop of blood collected on paper (a “Dry Blood Spot”) or human saliva samples collected as buccal swabs. This test was developed by Progenika. In 2022, A1AT Genotyping Test was also CE-marked. Although highly complex, the test has been designed so any molecular biology laboratory can process it with minimal human intervention.
AlphaID, our cheek swab that greatly simplifies the sample collection process, allows physicians and healthcare providers to obtain a sufficient oral sample for alpha-1 screening avoiding the need to order lab results. The test has been available in the U.S. since 2019. Our subsidiary Progenika has developed a free service named “AlphaID At Home Genetic Health Risk Service,” offering, directly to homes, a diagnostic solution to potential patients of alpha-1 antitrypsin deficiency. Since its FDA approval in 2022, this complex multidisciplinary project has brought together six international companies led by Progenika. Since its May 2023 launch, almost 100,000 AlphaID At Home kits have been requested and more than 35,000 people have taken the test.
Through our subsidiary Progenika, we manufacture a genetic diagnosis test for Familial Hypercholesterolemia (“FH”) using next generation sequencing technology (“NGS”). The Diagnostic business unit continues its efforts to broaden the Promonitor line, used to monitor biologic drugs as sales continue in Chile, select European Union countries, Australia and in the U.S. The Promonitor product line includes an ELISA (enzyme-linked immunoabsorbent assay) device line also developed by Progenika to monitor patients being treated with biological medicines for rheumatoid arthritis and other chronic inflammatory diseases. Progenika also co-developed with DIESSE Diagnostica Senese the Chorus Promonitor, an adaptation of the Promonitor ELISA kits to DIESSE’s Chorus Analyzer.
Pursuant to an exclusive agreement with AESKU Diagnostics GmbH & Co. (“AESKU”), we distribute autoimmunity diagnostic products in Chile, Mexico, Portugal and Spain.
The Bio Supplies Business Unit
The Bio Supplies Business Unit provides human biological materials for the biotechnology industry intended for research, clinical trials and manufacturing of pharmaceutical and diagnostic products. Most materials and products come from our collection centers with vertical integration manufacturing processes (in-house production). The Bio Supplies business unit accounted for €154 million, or 2.0% of our total net revenue in 2025.
Products in our Bio Supplies business unit cover a broad spectrum of applications where the need for human-based biological material cannot be replaced by other types of products, such as:
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Our Bio Supplies business unit also sold plasma to third parties in 2024 and 2025.
Other Activities and Operations (“Others”)
“Others” represents operations and activities, including the provision of manufacturing services to third parties and third-party plasma sales, and pharmaceutical products manufactured by the Grifols Group intended for hospital pharmacies.
Since 2022, the activities of our former “Hospital Division” were significantly reduced, which caused us to reallocate such activities and related products into a smaller business line named healthcare solutions (“Healthcare Solutions”), which is also accounted as Others. Others accounted for €243 million, or 3.2%, of our total net revenue in 2025.
The Healthcare Solutions business line provides services and manufactures products used by hospitals, blood banks, plasma collection centers and other healthcare systems. These products include parenteral solutions, robotics and software, as well as third parties’ products that we market to supplement the products that we manufacture. The Healthcare Solutions business accounted for €138 million, or 1.8%, of our total net revenue in 2025.
Research and Development
Research and development is a significant aspect of our business. Our principal research and development objectives are (i) to discover and develop new products, (ii) to research new applications for existing products and (iii) the improvement of our manufacturing processes to improve yields, safety and efficiency. In the years ended December 31, 2025, 2024 and 2023, our research and development spending was €426 million, €384 million and €395 million, respectively. In the last five years, we invested a total of €1.9 billion in research and development and innovation.
On December 31, 2025, we had an amount of approximately €1.7 billion as development costs in progress (compared to €1.7 billion at December 31, 2024). This includes (1) an amount of €267 million in ongoing research and development projects for products for neurodegenerative disorders, neuromuscular diseases, and ophthalmological diseases acquired from Alkahest; and (2) an amount of €895 million in ongoing research and development projects in plasma therapies acquired from Biotest (Fibrinogen and Trimodulin). See Note 7 to our audited consolidated financial statements included in this annual report.
In addition, as of December 31, 2025, we had 1,379 scientists and support staff dedicated to research and development.
We have several decades of successful innovation history. For example, we developed a unique fractionation design that reduces the risk of contamination and maintenance costs and increases the amount of product extracted per liter of plasma. We also developed the first centrifugation unit for the automated cleaning of blood cells. In addition, we were one of the first plasma fractionators to conduct double viral inactivation processes for Factor VIII and have designed and implemented a new process for the sterile filling of vials that reduces exposure to potential contaminants as compared to other existing processes. Further, we have developed a nanofiltration method of viral inactivation for our IG, alpha-1 PI, and ATIII products.
Our key therapeutic areas of study focus on immunology, hepatology and intensive care, pulmonology, hematology, neurology and infectious diseases. Our next innovations into these therapeutic areas will go beyond plasma-derived proteins, as our significant investments to increase R&D capabilities are allowing us to develop a new class of recombinant antibodies and small-molecules candidates.
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Biopharma Initiatives
We have a number of research and development projects in our Biopharma business unit underway, 12 of which are in the clinical development phase. The following table reflects the total number of research and development projects in our Biopharma business unit by development phase as of the end of the last three years.
As of December 31,
Development Phase
Discovery
Pre-clinical
Clinical
Post Commercialization Studies
Rest of projects
Total Biopharma Research and Development Projects
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82
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The table below presents the most important of our research and development projects:
Product Candidate
TherapeuticArea
ProductType
Potential Use
Xembify
Immunology
Plasma-derived
Secondary Immunodeficiency in Chronic Lymphotic Leukemia, Multiple Myeloma and Non-Hodgkin Lymphoma
Phase III (clinical trial program currently underway)
Alpha-1 Proteinase Inhibitor
Pulmonology
Emphysema due to congenital deficiency
Phase I/II (clinical trial program in subcutaneous administration currently underway). Phase I/II completed in 2025, with Phase III planned to start in 2026).
Phase IV US/ Phase III EU (clinical trial program in intravenous administration currently underway)
Immunoglobulin
Ophthalmology
Dry Eye Disease
Phase II (clinical trial program currently underway)
Fibrinogen
Hematology
Congenital deficiency & severe hypofibrinogen / acquired deficiency
Regulatory Approval received in 2025 for EU countries (Congenital & Acquired Deficiency) and U.S. (Congenital Deficiency)
Phase III U.S. Acquired Deficiency (clinical trial program to start in 2026)
Trimodulin
Infectious diseases
Severe community acquired pneumonia (“sCAP”)
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Xembify – Secondary immunodeficiency in CLL. The primary objective of this clinical trial (NCT05645107) is to obtain an indication for Xembify in secondary immunodeficiency as result of chronic lymphocytic leukemia (“CLL”), multiple myeloma (MM) and Non-Hodgkin Lymphoma (“NHL”). CLL is the most common leukemia in older adults in Western countries, with an average age at diagnosis of 72. The disease is characterized by an accumulation of monoclonal, mature, CD5+ B cells in the peripheral blood, bone marrow, and secondary lymphoid organs. Patients with CLL are subject to an increased risk of infections and recurrent or severe infections are a major cause of morbidity and mortality in patients with CLL, causing between 30% and 50% of deaths in this population. MM is the second most common hemato malignancy, with an estimated incidence of 7.1 and 4.5 to 6.0 cases per 100,000 people per year in the United States and Europe, respectively. In general, MM is frequently diagnosed in patients from 65 to 74 years of age. MM is a clonal disorder characterized by the accumulation of malignant mature plasma cells in the bone marrow (and sometimes also with extramedullary involvement) and the production of an abnormal monoclonal paraprotein, named the M protein. NHL represents a heterogeneous group of malignancies of different biology and prognosis. NHL includes many subtypes, each with distinct epidemiologies; etiologies; morphologic, immunophenotypic, genetic, and clinical features; and responses to therapy. These tumors originated from lymphoid tissues, mainly of lymph nodes. Current evidence suggests that hypogammaglobulinemia resulting of the secondary antibody deficiency in B-cell lymphoproliferative diseases such as CLL, MM and NHL predispose the patient to develop serious infections due to the patient’s underlying disease or their cancer. The Phase III clinical trial is aiming to enroll more than 380 patients in sites across the United States and in European countries to support an FDA submission in the United States.
Alpha-1 Proteinase Inhibitor – Emphysema due to congenital deficiency. SPARTA (Study of Prolastin-C Randomized Therapy with Alpha-1 augmentation; NCT01983241), our Phase IV (U.S.) / Phase III (E.U.) clinical trial designed to determine if alpha-1- antitrypsin deficiency (AATD) (alpha-1) patients with emphysema have a slower progression of lung tissue loss when treated weekly with two separate dose regimens of intravenous (IV) Grifols Prolastin-C Alpha-1. Alpha-1- antitrypsin deficiency (AATD) is an underdiagnosed genetic disorder that can result in chronic obstructive pulmonary disease (COPD), a group of respiratory diseases that includes emphysema, which can occur when a patient has low levels of AAT, a protective protein that safeguards the lungs. The currently approved dosage is 60 mg/kg in weekly IV infusions. SPARTA, the largest randomized, double-blind, placebo-controlled study on AAT augmentation therapy to-date, is designed to evaluate the potential of Prolastin-C to significantly reduce emphysema progression in alpha-1 patients by raising AAT protein levels through weekly administration of two active dose levels versus placebo. The clinical trial is taking place across 16 countries and more than 50 sites. It will evaluate the efficacy and safety of two separate dose regimens of Prolastin-C (60 and 120 mg/kg/week) versus placebo for 156 weeks (i.e., three years), measuring the rate of pulmonary-tissue loss through whole lung computed tomography (CT) densitometry as the primary measure of clinical efficacy.
We have also conducted a Phase II/III study (NCT04722887) evaluating Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% (Alpha-1 15%), a subcutaneous (SC) AAT treatment being compared to Liquid Alpha1-Proteinase Inhibitor (Human) IV. This first in-human SC approach to treating alpha1-antitrypsin deficiency, if proven successful in clinical trials, could give patients the convenience and flexibility to administer their medication from home. We completed the Phase I/II study in 2025 and plan to start the Phase III study in 2026.
Immunoglobulin. In 2023, we entered into a global collaboration and licensing agreement with Selagine, a pioneering developer of eye disease treatments, to explore the potential of an immunoglobulin eye drop to treat dry eye disease (DED), a pathology that affects more than 100 million people worldwide in 2023. In a pilot Phase I/II clinical trial, subjects treated with eye drops based on Grifols Flebogamma DIF twice daily for eight weeks, secured a significant reduction in the signs and symptoms of DED, and with no difference in tolerability or adverse events. Several different sources of inflammation, including proteins (cytokines or chemokines), cells (neutrophils, T-cells and dendritic cells) and pathogenic antibodies, are present on the ocular surface in DED and contribute to its signs and symptoms which may benefit from application of immunoglobulin. We completed an FDA pre-IND meeting in respect of this immunoglobulin in September 2023. In 2024, we successfully completed the preclinical development phase. In 2025, we completed IND submission and initiated enrollment for the phase II clinical trial for the use of Flebogamma DIF 5% in the treatment of DED.
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Fibrinogen. The AdFirst study is a prospective, active-controlled, multicenter Phase III study investigating the efficacy and safety of the fibrinogen concentrate BT524 in patients with acquired fibrinogen deficiency (“AFD”), which typically occurs during surgical procedures when there is insufficient fibrinogen to arrest bleeding. Patients who have high blood loss during planned spinal and abdominal surgery are randomized 1:1 to treatment with BT524 or FFP/Cryoprecipitate. To evaluate efficacy, further blood loss is compared between the two treatment options. The study concluded in September 2023. The AdFirst Study met its primary endpoint in February 2024, demonstrating that the fibrinogen concentrate BT524 is as effective in treating AFD as the current standard of care for this condition. The concentrate reduces intraoperative blood loss in patients with AFD undergoing planned major spinal or abdominal surgery.
In 2025, we received approval in Germany for congenital fibrinogen deficiency (CFD) and Acquired Fibrinogen Deficiency (AFD), and approval in the United States of a Biologics License Application (BLA) for BT524 for the treatment of CFD. Following discussions with the FDA, we decided to strengthen the clinical evidence for AFD with U.S. patients before seeking approval for this indication in the United States. We launched the Fibrinogen product in Germany in late 2025 and expect to start selling it in the United States in 2026. We hold significant patents on the fibrinogen production process.
Trimodulin. Study 996: This multinational Phase III clinical trial plans to enroll approximately 590 adult hospitalized patients with severe sCAP (Community Acquired Pneumonia) requiring invasive mechanical ventilation. The ESCAPE trial will be conducted worldwide and patients are treated either with trimodulin or with a placebo as add-on therapy to standard of care.
The clinical concept of this prospective, double-blind, placebo-controlled, Phase III trial was developed based on promising results from the previous Phase II clinical trial (“CIGMA”) with 160 sCAP patients requiring invasive mechanical ventilation. In the CIGMA trial, a subgroup of patients with signs of severe inflammation showed an encouraging reduction in mortality rate through rapid normalization of inflammation when treated with Trimodulin. The trial is currently being conducted in up to 20 countries, including the United States, and recruitment of patients is ongoing.
Other Biopharma research and development projects undertaken during the last three years included:
2025:
2024:
2023:
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All clinical trials involve risks and uncertainties. Preclinical and clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more of our clinical trials can occur at any stage of testing. We may experience numerous unforeseen events during or as a result of preclinical testing and the clinical trial process that could delay or prevent our ability to receive regulatory approval or commercialize our product candidates. For a discussion of these unforeseen events, see Item 3 of this Part I, “Key Information—D. Risk Factors—Risks Relating to the Company and Our Business—We may not be able to commercialize products in development.” Upon the completion of each of the development stages we evaluate the results achieved as compared to the objectives pursued. Each of the key projects listed above has met our expectations with respect to results at the various development stages and we expect to move forward with the development process for each.
We believe that our current liquidity is sufficient to fund the ongoing costs of our key projects listed above through their completion as well as our other research and development initiatives.
Diagnostic Initiatives
Research and development in the Diagnostic business unit supports various business areas, including transfusion medicine, clinical diagnostics, and the recombinant protein business. The Diagnostic business unit focuses on the development of in vitro diagnostic reagents/assays, instrumentation, and software for donor screening, which includes pathogens detection to assure safety and blood typing tests to determine donor/recipient blood compatibility. Here, research and development focus on opportunities to develop new assays for emerging pathogens, increase multiplex test capabilities (simultaneous detection of several analytes in a single reaction), as well as improved automation solutions in order to increase efficiency and throughput for customers. The Diagnostic business unit also develops products for clinical diagnostics, including a next generation immunoassay platform in the area of neurology and oncology, as well as a next-generation molecular testing platform covering infectious diseases.
The research and development team employs a diverse technology portfolio, including transcription mediated amplification (“TMA”), polymerase chain reaction (“PCR”), next generation sequencing (“NGS”) for molecular assays, immunologic based methods using red blood cells (“RBC”), and agglutination. We are also leveraging ultrasensitive single molecule counting detection technology to develop new immunoassays, as well as a fast-PCR technology to develop next generation molecular assays. We continue research and development for new recombinant proteins, antibodies and enzymes as critical raw materials to support internal and external diagnostics customers in various fields such as infectious diseases, neurodegenerative diseases and immunohematology. Our Diagnostics Research & Development team continues to evaluate new technologies and research tools, including artificial intelligence (AI), to assess their potential for improving our competitive advantage and for integration into our development portfolio.
In 2023, the Diagnostics business unit continued to release innovative products for our immunohematology product line, including new software versions across the platform portfolio to increase efficiency and productivity for our customers. We launched our BTM middleware in the United States, while also achieving regulatory approval in China for Eflexis, our flagship blood typing platform, in order to expand our geographic footprint. We also launched DC Scan Plus, a new DG Gel test under IVDR regulation that extends specificity beyond routine analytes and improves patient care by increasing sensitivity and specificity, thereby improving clinical patient management and outcomes in the field of donor screening. We also released new versions of our pooler software, as well as software to facilitate increased automation and ease of use for testing labs. Additionally, we launched in the United States the first-ever free direct-to-consumer program (consisting of an innovative and sophisticated genotyping test and service) to screen for the genetic risk of alpha1-antitrypsin deficiency (Alpha-1).
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In 2024, the Diagnostics business unit continued to develop and introduce new high multiplex donor screening solutions to the market to drive efficiency improvements and address developing trends in transfusion-transmitted diseases. The team obtained CE mark approval for the Procleix ArboPlex Assay, which tests for four arboviruses: chikungunya virus RNA, dengue virus RNA, West Nile virus RNA and Zika virus RNA. The team also completed the U.S. clinical trials for the Ultrioplex W assay, which detects HIV-1, HIV-2, hepatitis C virus (“HCV”), hepatitis B virus (“HBV”), and West Nile virus (“WNV). Additionally, we completed U.S. clinical trials for the Procleix Plasmodium assay and developed a research use only (“RUO”) assay to screen for severe fever with thrombocytopenia syndrome virus (“SFTSV”) in an effort to address oncoming emerging pathogens. We are also developing new software to support new assay products on the Procleix donor screening platform, as well as to enable efficiency improvements to middleware solutions and increased productivity for our donor screening customers. In the field of blood typing, the Diagnostics business unit advanced development of a next generation blood typing platform, initiated development of an automated antisera program with extended phenotyping for the United States, and launched multiple innovative software releases across the instrument portfolio, including an automated titration method on Eflexis — all with the goal to increase efficiency and productivity for our customers. Additionally, the 2024 commercial success in Europe of our innovative blood typing interference solution for anti-CD38 antibody-treated patients has driven the pursuit of future expansion of this solution to the U.S. market.
In 2025, the Diagnostics business unit continued to develop and introduce new high multiplex donor screening solutions to the market to drive efficiency improvements and address developing trends in transfusion-transmitted diseases.
The new Ultrioplex W assay, which detects HIV-1, HIV-2, hepatitis C virus (“HCV”), hepatitis B virus (“HBV”), and West Nile virus (“WNV), was under review by the FDA in 2025, with some additional studies requested and started at the end of 2025. We also submitted to the FDA in 2025 the Procleix Plasmodium assay as well as 510(k) submissions for multiple Procleix controls. R&D also provided a research use only (“RUO”) assay that we developed to the Japanese Red Cross to screen for severe fever with thrombocytopenia syndrome virus (“SFTSV”) in an effort to address oncoming emerging pathogens. Our R&D team initiated development of a next generation pooler, strengthened our in-house software capabilities, and secured secondary sources for critical consumables for business continuity. We also released multiple software enhancements to address cybersecurity and increase efficiency and productivity for our molecular donor screening customers.
In the field of blood typing, the Diagnostics business unit advanced development of a next-generation blood typing platform, continued development of an automated antisera program with extended phenotyping for the United States, and expanded DG Gel products into China. We also launched multiple innovative software releases across the instrument portfolio, including an enhanced automated titration method on Eflexis and new middleware — all with the goal of increasing efficiency and productivity for our customers. Additionally, the increasing commercial success in Europe of our innovative blood typing interference solution for anti-CD38 antibody-treated patients has driven the pursuit of future expansion of this solution to the U.S. market and additional countries in 2025.
Moreover, the Diagnostics business unit in 2025 continued to partner with Inpeco to develop a total lab automation solution for blood/plasma testing labs.
In 2024, the Diagnostics business unit filed over 16 new patents, spanning composition of matter, methods and devices, further growing our intellectual property portfolio and competitive position in the areas of molecular testing, infectious disease, blood typing, clinical diagnostics. In 2025, the Diagnostics business unit filed over 12 new patent applications and two new design applications, spanning composition of matter, methods and devices, further growing our intellectual property portfolio and competitive position in the areas of molecular testing, infectious disease, blood typing, clinical diagnostics.
In 2025, the Diagnostics business unit focused on developing blood typing platforms to ensure compatibility between donors and recipients. These gel-based assays identify major blood groups like ABO and Rh, as well as detect less common blood groups that are still highly relevant to human pathologies, such as sickle cell anemia and cancer. We also began developing new tests for personalized medicine, focused on prognosis, response prediction and monitoring of biologic drugs, as well as molecular diagnostic and prognostic tests in oncology, autoimmunity, cardiovascular medicine and the central nervous system.
In 2025, more than 37 million blood donations were analyzed using Grifols’ NAT technology and more than 68 million blood typing cards with gel technology were supplied.
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Other Initiatives
Through our subsidiary Araclon Biotech, S.L. (“Araclon”), we are dedicated to finding solutions that promote new diagnostic and therapeutic approaches to Alzheimer’s disease, to be applied in the early stages of the disease. Araclon is working on the validation of an early diagnostic test and the development of a vaccine (ABvac40) to combat Alzheimer’s disease in the asymptomatic stage. The vaccine has passed the animal experimentation stage and Phase I and Phase II clinical trials have been completed.
The Phase II trial of ABvac40, initiated in 2018 and ended in 2023, showed positive outcomes. ABvac40 had a good safety profile, stimulated a robust immune response against Aβ40 peptide, and demonstrated potential cognitive benefits in early-stage AD patients, meeting primary endpoints. Though the trial was not designed to assess efficacy on neuropsychological scales, we observed promising results in secondary endpoints between the ABvac40-treated group and the placebo group. Post-hoc analyses in 2024 indicated greater benefits for patients with amyloid deposits, with fewer cases of significant decline on the Mini-Mental State Examination (“MMSE”) scale, especially among top responders. We noted lower incidence of new cerebral microhemorrhages in ABvac40-treated patients compared to placebo. In 2025, we presented final results from the phase II clinical trial of ABvac40, an active vaccine against the Aβ40 peptide for the treatment of early-stage AD, which showed a favorable safety profile and a robust and durable immune response against Aβ40, meeting the primary objectives of the clinical study. We continue to evaluate the data and share our findings at various conferences, while also engaging with companies in the Alzheimer’s disease field to explore licensing-out opportunities.
Our subsidiary Alkahest focuses on identifying proteins that change with age and also with the onset of diseases that have a biological impact. To date, Alkahest has identified over 10,000 separate proteins using advanced molecular analysis techniques at the cellular level. In 2024, Alkahest pivoted to advancing Chronos, a target proteomic platform that aims to detect diseases before they manifest phenotypically. Chronos’ initial focus is Parkinson’s Disease, with plans to move to other disease areas. In January 2025, Alkahest initiated the Chronos research program to analyze longitudinal plasma samples for early biomarkers associated with Parkinson’s disease. Chronos remains a research-stage initiative, and no diagnostic products or therapeutic candidates have been approved or submitted for regulatory approval to date.
Our subsidiary GigaGen Inc (“GigaGen”) is developing a novel class of therapeutics, recombinant polyclonal antibodies, to address unmet needs in infectious disease. In 2025, the phase I clinical trial evaluating the safety and tolerability of GIGA-2339, GigaGen’s first recombinant polyclonal candidate for the treatment of hepatitis B virus (HBV) infection, continued recruitment. GIGA-2339 includes more than 1,000 recombinant human antibodies targeting HBV to mimic the body’s natural immune response, with the potential to eliminate the virus and activate the immune system. There is presently no cure for HBV, which affects more than 296 million people globally and causes over 800,000 deaths every year. Additionally, in 2025, GigaGen’s phase I clinical trial evaluating GIGA-564 for the treatment of advanced solid tumors successfully completed the phase I-a dose-escalation trial and is currently enrolling patients in the phase I-b multiple-dose cohorts.
In 2025, we developed a strategic partnership with the Biomedical Advanced Research and Development Authority (“BARDA”), part of the U.S. Department of Health and Human Services, to evaluate the nonclinical efficacy of ocular surface immunoglobulin (“OSIG”) eye drops for the treatment of sulfur mustard-induced ocular injury. This proof-of-concept study aims to assess the anti-inflammatory and immunomodulatory potential of OSIG in neutralizing the long-term effects of exposure to sulfur mustard — a chemical warfare agent known to cause debilitating corneal damage. The investigational OSIG therapeutic is being repurposed from an ongoing development program targeting dry eye disease (“DED”), for which a Phase II clinical trial began in 2025. This initiative represents a significant step in expanding the applications of our IG platform into ophthalmology and biodefense. In addition, in 2024, GigaGen was awarded a $135 million contract by BARDA to develop a recombinant polyclonal antibody therapy for botulin neurotoxins and a second biothreat of interest to BARDA that will be determined at a later date.
In 2025, we also initiated an R&D collaboration with FcR Therapeutics, a Dutch company, to discover and develop new therapeutics targeting 2 Fc receptors for the treatment of autoimmune diseases.
Seasonality
Our businesses are not significantly affected by seasonal trends.
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Raw Materials
Plasma is the key raw material we use to make our products and therapies. We obtain our plasma primarily from our network of plasma collection centers located in the United States and Europe (Germany, Austria, Czech Republic, and Hungary), and, to a much lesser extent, from third party suppliers. See “—Principal Activities—The Biopharma Business Unit—Plasma Procurement.” We are dependent on healthy individuals to donate human plasma to develop and manufacture our products. As such, our cost to acquire plasma may vary depending on the ability of donors to visit our plasma collection centers and the compensation we pay for the plasma donations. See Item 3 of this Part I, “D. Risk Factors— Risks Relating to the Company and Our Business—A significant disruption in our supply of plasma, including as a result of macroeconomic conditions, pandemics or changes in immigration policies and enforcement could have a material adverse effect on our business and our growth plans.”
In 2025, we continued to manage our plasma supply efficiently, maintaining stability in cost per liter. This performance was supported by improved operational yields at donation centers, driven by the implementation in recent years of more efficient plasmapheresis equipment based on nomogram technology, which has increased process productivity. We also continued to optimize cost per liter of plasma collected through various initiatives aimed at streamlining structural costs, optimizing donor compensation, improving the donor experience, and increasing operational efficiencies across the entire center network.
Our plasma supply increased significantly in 2025 in comparison to the volumes collected in 2024, validating the effectiveness of the strategic measures implemented during 2023 and 2024 to enhance plasma collection and manufacturing efficiencies, strengthen financial management, and execute our Operational Improvement Plan (as defined in Item 5 of Part I, “A. Operating Results—Factors Affecting Our Financial Condition and Results of Operations—Operational Improvement Plan”). In 2025, our plasma collection increased significantly in comparison to 2024 as a result of our acquisition of plasma donation centers from ImmunoTek in February 2025, plus the optimization of our existing plasma centers. We also saw an increase in unique donors to over one million people. In addition, we implemented new nomogram technology in 80% of our U.S. plasma centers.
We closely monitor, continuously review and revise the supply sourcing strategy for our products to identify in a timely manner any risks in our supply chain. Where necessary, we strategically manage our inventory levels of either key materials or finished products to address potential risks relating to operational and quality issues, production capacity and single sourcing among others. We also continue to monitor the efficiency of our plasma collection platform and have concentrated all our plasma testing into laboratories in Austin and San Marcos, Texas, Memphis, Tennessee, Boca Raton, Florida, Leipzig and Dreieich, Germany, Parets del Vallés, Spain, and Cairo, Egypt (through our joint business with NSPO).
Our long-term aim is to further strengthen our leadership through the development of new and differentiated plasma-derived therapeutics, and the expansion of our global plasma collection footprint via acquisitions and greenfield projects, as described below:
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The principal raw materials for our intravenous therapy products are plastic and glass bottles, which we purchase from various European suppliers.
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Marketing and Distribution
We currently sell Biopharma, Diagnostic and Healthcare Solutions products to hospitals, specialty pharmacies, clinics, GPOs, governments and other distributors in over 100 countries.
For Biopharma and Healthcare Solutions in the United States, the sales model is complex, with many intermediaries, requiring us to execute multi-faceted arrangements for the distribution of our products. Sales of finished goods are distributed through various channels such as distributors, wholesalers, specialty pharmacies, home health care companies, clinics, hospitals, government entities and directly to physician offices. Payers and purchasers also control access to products, requiring separate negotiations with payers and GPOs. GPOs are entities that act as purchasing intermediaries for their members, which are primarily hospitals. GPOs negotiate the price and volume of supplies, equipment and pharmaceutical products, including plasma derivatives, used by their members.
We market our products to healthcare providers and other decision-makers, such as those in hospitals and pharmacies, through focused sales presentations. Although price and volume are negotiated through contractual agreements with intermediaries, demand for our products is generated through promotional efforts by Grifols’ sales representatives. In the case of GPOs, the actual sales are made to the authorized distributor(s) of each GPO at the contract price, and the distributor then sells the products to the members of that GPO. We promote our products directly to the GPO’s members. For safety and post-sale service reasons, the distributor is required to provide us with the specifics of the ultimate delivery to the client.
For Diagnostics, the sales model consists of direct sales of Grifols solutions by a dedicated sales force primarily focusing on Integrated Delivery Networks (IDNs) and the GPOs that represent them. For IDNs belonging to a GPO, pricing is negotiated with the GPO.
We market and promote our solution to healthcare professionals and other decision makers within hospitals and contracts are entered into directly with hospitals, following requests for proposals, typically for a period of three to seven years.
For Biopharma, the sales, marketing and distribution process is different in Europe, where the bulk of sales are generally made directly to hospitals. We have developed long-standing relationships with major hospitals in most of our European markets, and we believe that hospitals are loyal customers that recognize the high quality and safety of our products, our reliability as a supplier and the strong product expertise and service provided by our sales representatives. Due to the nature of our customer base and the prevalence of repeat sales in the industry, we market our products through focused sales presentations rather than by advertising campaigns.
Sales to Eastern Europe, the Middle East and some Asian countries are made mostly by third parties outside of our sales network. Our sales in Latin America are made mainly by our sales network in Chile, Brazil and Mexico, as well as by third-party distributors elsewhere.
For Diagnostics in Europe, the Middle East and Africa, sales and marketing is done through affiliates and distributors. The majority of the customer base for our Diagnostics division products is public and follows local public procurement laws tender processes. In Asia, Latin America and the Pacific, we sell through a mix between direct sales and sales through distributors.
In China, sales and marketing are made by channel partners and sub-distributors with indirect support from the our affiliate in China.
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Sales Representatives
For Biopharma, we require our sales representatives to be able to highlight the technical differences between our products and those of our competitors. This skill requires a high degree of training, as the salesperson must be able to interact and discuss product differences with doctors, pharmacists and other medical staff in an appropriate manner. Sales representatives call on office-based healthcare providers and hospital-based healthcare providers, departmental heads, purchasing agents, senior hospital directors, lab directors and pharmacy managers. We compensate our sales representatives by means of a fixed salary and a bonus component based on sales achievements. We divide our sales efforts along the lines of our main product categories. Our sales personnel are primarily located in Europe and the United States, but we also have sales personnel in Latin America and Asia-Pacific.
In our Biopharma business unit, we utilize mixed sales units comprised of both marketing and sales personnel. In some countries, we have product line-specific sales units for immunology & neurology, pulmonary, intensive care and coagulation factors.
For Diagnostics, we require our sales representatives to be able to highlight the value of our solutions compared to our competitors. This ability requires a high degree of technical and sales training, as well as soft skills to aptly describe our products. The salesperson must be able to interact and discuss the value of our solutions to all levels of stakeholders. The interactions with customers are a mix of in-person and virtual meetings.
Advertising
We participate in medical conferences, conventions and fairs and occasionally publish advertisements in medical journals and trade magazines. This promotional activity is also supported by online activities.
Distribution
We believe that having our own distribution network staffed with highly trained personnel is a critical element of a successful sales and marketing effort. Through this network, we are able to provide high-quality pre- and post-sales service, which we believe enhances brand recognition and customer loyalty. Our distribution network is experienced in the proper handling of our products and allows us to know where our products are located, enabling us to act quickly in the event of a suspected problem or product recall.
Our distribution network personnel are located in Europe, Latin America, the United States and Asia-Pacific and handle the distribution of our biological medicine, diagnostic and other medical products as well as goods manufactured by other premier healthcare companies that complement our own products.
During 2025, we distributed the majority of our products through our own distribution network. In some cases, particularly in the field of Diagnostics, we distribute products through marketing partners and third-party distributors. We have a direct presence in more than 30 countries and we carefully select distributors in the countries where we do not have a direct presence. We have a responsive, effective logistics organization that is able to punctually meet the needs of hospital centers and other customers throughout the world.
Our sales, marketing and distribution network included 1,613 employees as of December 31, 2025, which included 1,419 sales and distribution personnel and 194 marketing employees.
Each of our commercial subsidiaries is responsible for the requirements of its respective local market. It is our goal for each commercial subsidiary to be recognizable as one of our companies by its quality of service, ethical standards and knowledge of customer needs. Strong local knowledge enables us to build and maintain long-term relationships with customers to earn their trust and confidence.
We continually require technical services to perform the installation and maintenance of the systems sold in our medical equipment and software offerings. The Diagnostics business unit and the Healthcare Solutions division each have their own structure of support staff appropriately trained to provide such services, which is an important part of the competitive success of these solutions.
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In the Diagnostics business unit, we rely on distributors to sell and support our products. We have 163 distributors in Europe, the Middle East, Africa, Latin America, China and Asia Pacific. In order to provide responsive, region-specific services and maintain long-standing relationships, local presence and proximity to the customers are valuable assets to our Diagnostic business. Our Diagnostics business unit engages in direct sales and marketing and offers post-sale support in 16 countries. As of December 31, 2025 our Diagnostics business unit had 1,600 employees.
Safety in the blood transfusion process is the highest priority for us. We are constantly innovating new solutions to improve safety, efficiency, and standardizations to promote the fast availability of safe blood to patients globally.
Patents, Trademarks and Licenses
Patents and Trademarks
Through our patent ownership, co-ownership and licensing, we seek to obtain and maintain intellectual property protection for our primary products.
As of December 31, 2025, we owned 2,528 patents and patent applications in various countries throughout the world, of which 543 are in the final application process. In some countries, these patents grant a 20-year protection period. Of these patents, 1,276 are set to expire in the next ten years. The patent for the production process of thrombin expired in January 2024, and the patent for the Coagulometer Q expired in November 2025.
As of December 31, 2025, we also owned 2,929 trademarks and trademark applications in various countries throughout the world, of which 102 are in the final application process. In addition, we co-own certain patents and patent applications with third parties, including patent rights co-owned with Novartis following the Novartis Acquisition.
We maintain a department with personnel in Spain and Germany to handle the patent and trademark approval and maintenance process and to monitor possible infringements.
Patents for Plasma Derivative Products
As of December 31, 2025, we owned 1,978 patents and patent applications related to plasma derivatives, including 896 in Europe, 277 in the United States and Canada, and 805 in the rest of the world. The most important of these patents relate to:
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Patents for Diagnostic Products and Healthcare Solutions
As of December 31, 2025, we owned 550 patents and patent applications related to our Diagnostic products and Healthcare Solutions business line, including 312 in Europe, 91 in the United States and Canada and 147 in the rest of the world. The most important of these patents relate to the:
Licenses from Third Parties
We license certain intellectual property rights from third parties, including Singulex, Novilux and Hologic. Singulex granted us an exclusive worldwide license under certain intellectual property rights to develop, manufacture and commercialize certain products and services for blood donor and plasma screening. Novilux granted us a non-exclusive worldwide license under certain intellectual property rights to develop, manufacture and commercialize certain products for the in vitro clinical diagnostic field. Pursuant to an intellectual property license with Hologic, we obtained a fully paid-up license to certain of Hologic’s intellectual property for use in the NAT Donor Screening Unit.
In addition to licenses, we acquire intellectual property rights from third parties, such as Anapa Biotech A/S, to support the development of new products that will enable us to expand our business in the field of molecular testing.
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Licenses from Government Authorities
Government authorities in the United States, at the federal, state and local level, and in other countries throughout the European Union, Latin America, Asia and elsewhere, through licenses, approvals, reviews, inspections and other requirements, extensively regulate the research, development, testing, approval, manufacturing, labeling, post-approval monitoring and reporting, packaging, promotion, storage, advertising, distribution, marketing and export and import of healthcare products such as those that we collect, manufacture, sell or are currently developing.
For example, in order to sell our plasma derivative products we must hold appropriate product licenses from applicable governmental authorities. We have 1,117 Biopharma product licenses registered in 90 countries, which include the licenses we hold from the FDA for the sale in the United States of IG, A1PI, albumin, Factor VIII, Factor IX, ATIII and PTC. The production, marketing and sale of many of our Diagnostic business unit products are subject to the prior registration of such products with the relevant authorities of the applicable jurisdictions. We have 4,117 diagnostic product licenses registered in 50 countries in Europe, the United States, Canada, Latin America, Oceania and Asia.
Governmental oversight extends to the various facilities involved in our operations. For example, our Parets and Murcia facilities are subject to applicable regulations and standards of the European health authorities. With respect to oversight by the FDA, our Instituto Grifols Biopharma plant at our Parets facility has been registered with the FDA since 1995, and our other manufacturing facilities maintain FDA registration, and all are subject to FDA standards. We lease most of our plasma collection centers as well as our main laboratory facility located in Austin, Texas, and maintain licenses with the appropriate regulatory authorities, including the FDA, for all of these locations.
For more information on government licenses and regulation, see “—Principal Activities” above and “—E. Regulatory Matters” below.
Regulatory
For detailed information regarding the regulations applicable to our business, see “—E. Regulatory Matters” below.
Insurance Coverage
General and Product Liability
We have a program of insurance policies designed to protect us and our subsidiaries (including the United States subsidiaries) from product liability claims. Effective as of May 1, 2025, we have product liability insurance coverage for up to $230 million per claim and in annual aggregate for Diagnostic and Bio Supplies business units for products manufactured in all of their facilities and for third-party product sales. That limit is $395 million per claim and in the annual aggregate for Biopharma business unit. This policy expires on April 30, 2026, and we expect to renew it for another year prior to such expiration date.
Our liability program also protects from certain environmental liabilities arising in those countries in which Grifols’ subsidiary companies have operations. This risk is covered up to a maximum of $230 million per claim and in annual aggregate.
We maintain a separate liability insurance policy for donor centers. The policy covers their professional liability for plasmapheresis activities and expires on April 30, 2026. The maximum amount of coverage for liability claims under the policy is $15 million per claim and in the annual aggregate. In addition, our general liability insurance provides excess coverage.
Property Damage and Business Interruption
Our property damage and business interruption insurance program covers us and our subsidiaries (including the United States subsidiaries). This insurance program, which expires on April 30, 2026, covers damages suffered by plants and buildings, equipment and machinery. Under the current terms, the insurer will cover damages to our facilities produced by fire, smoke, lightning and explosions, among others, for up to $2 billion per occurrence (although some sub-limits for other coverages may apply). It also covers property damage produced by flooding, for up to $110 million per claim and in the annual aggregate. This policy also covers loss of profit up to a certain amount.
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We also have a transit and inventory insurance program, which covers damages to raw materials, supplies, semi-finished products and finished products for up to $25 million per claim for transit and $700 million for inventory in annual aggregate. This insurance program expires on April 30, 2026, and we expect to renew the policy for another year prior to its expiration date.
Cyber
Our cyber insurance covers financial losses up to $95 million resulting from data breaches and ransomware attacks. This insurance program expires on April 30, 2026, and we expect to renew the policy for another year prior to its expiration date.
Self-insurance
We are self-insuring part of the risks described above through the purchase of a portion of the relevant insurance policies by Squadron Reinsurance DAC, one of our wholly owned subsidiaries. We also self-insure a portion of the main insurance global programs such as general liability, property and business interruption, professional liability for donor centers, transit, inventory and cyber.
We self-insure $50 million per claim per year of our global liability program (except that amount is $85 million per claim and in the annual aggregate for the Biopharma business unit), for property damage and business interruption up to a maximum annual aggregate of $10 million, for transit and inventory losses up to a maximum annual aggregate of $5 million, for professional liability in the donor centers up to a maximum annual aggregate of $5 million, and for losses related to cyber-security risks up to a maximum annual aggregate of $5 million. These amounts are in excess of the deductibles for each of the policies that make up our insurance programs.
Climate Change
Aligned with the United Nations’ plan to achieve the sustainable development goals defined in its 2030 agenda, we have set commitments to help preserve the environment. Since 2020, our corporate environmental program included the reduction of emissions and decarbonization milestones for our business. By 2030, we are committed to reducing our greenhouse gas emissions, increasing our energy efficiency per unit of production and ensuring that 100% of the electricity consumed in our facilities originates from renewable sources.
Since 2024, our short-term emission reduction targets have been approved by the Science Based Targets initiative (SBTi), which verified that our Scope 1, 2 and 3 commitments align with the ambition of limiting global warming to 1.5°C. As part of our broader climate strategy and goal of achieving climate neutrality by 2050, in 2025 we implemented a transition plan towards Net Zero. This plan provides a structured pathway to advance decarbonization and ensure the long-term resilience of our business model in a low-emissions economy. It builds on the targets validated by the SBTi and establishes a clear framework for reducing emissions across the value chain.
In the short term, we have committed to:
We have also set an internal long-term objective—distinct from but aligned with our SBTi-validated targets—to reduce Scope 1, 2 and 3 emissions by 90% by 2050 compared with 2022, thereby reaching Net Zero by 2050. This roadmap positions us to advance coherently with international decarbonization frameworks and global climate neutrality commitments.
Our action plan to achieve such SBTs includes (i) minimizing air travel among our different industrial and operational locations by increased use of technology such as video calls; (ii) increasing the levels of remote work by our employees with policies providing for flexible hour; (iii) optimizing logistics in our plasma transportation network, including by shipping intermediate products from our facilities in the United States to Ireland by ship, rather than air transport; (iv) minimizing the impact of employee travel and commutes with measures such as providing subsidized shared transportation service to employees in our facilities; and (v) increasingly rely on renewable energy by purchasing energy generated from renewable sources through PPAs.
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In 2025, we consumed 272 million kWh of renewable electricity, 56.0% of our total consumption, through actions such as power purchasing agreements (“PPAs”), the use of two photovoltaic plants (in Barcelona and Murcia) and refrigeration plants with refrigerant gases with a global warming potential equal to zero. With the aim of replacing the most polluting technologies, we regularly analyze the technological options available on the market, with a special focus on technologies that increase the climate resilience of our facilities.
Our GHG emissions inventory covers all scopes (1, 2, and 3) and categories, following the GHG Protocol and encompassing all company activities:
Since 2019, we have regularly updated our climate risk map as part of our integrated approach to managing climate-related risks and opportunities. This framework helps the company determine whether a potential impact constitutes a material risk or opportunity. In 2025, within the framework of the company’s resilience assessment, we updated our climate risk and opportunity analysis based on recommendations from the international scientific community and the general criteria established by key reporting frameworks such as the CSRD. The analysis included a stressed pessimistic scenario (SSP5-8.5) from the Intergovernmental Panel on Climate Change to assess physical climate risks; a stressed optimistic scenario (“NZS”) from the International Energy Agency to evaluate transition risks; and a strategic analysis aligned with recommendations of the Task Force on Climate-related Financial Disclosures, based on a 2°C global warming scenario (SSP2-RCP-4.5). Additionally, we are developing a Decarbonization Plan that is expected to be published in 2026.
We also estimated the potential financial impacts of each material risk and opportunity in respect of climate change. For this process, we evaluated 27 potential climate-related risks and opportunities across the company’s entire value chain, including suppliers (upstream), our own operations and infrastructure, and the distribution and use of our products (downstream). Following this analysis, we identified 12 material risks and opportunities: 2 physical risks, 6 transition risks and 4 opportunities.
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Grifols, S.A. is the parent company of the Grifols Group, which was comprised on December 31, 2025, of 90 companies, associates and other subsidiaries. Subsidiaries in which Grifols, S.A. directly or indirectly owned the majority of equity or voting rights have been fully consolidated, as have been companies that Grifols, S.A. controls. In addition, there were three companies that were accounted for using the equity method, because Grifols, S.A. owned between 20% and 50% of its share capital and had no power to govern its financial or operating policies.
See Notes 1 and 2(b) to our audited consolidated financial statements included in this annual report on Form 20-F for details of our consolidated and non-consolidated companies.
Our headquarters is in Barcelona, Spain. As of December 31, 2025, we owned or leased facilities in eight countries, with our main factory locations established in Spain, Germany and the United States. We currently own or lease manufacturing facilities in 16 sites in 7 different locations, four of which have plasma fractionation capabilities. We are currently constructing two plants in Montreal and Egypt that, when complete, will also have plasma fractionation capabilities. The table below shows the geographic location and business purpose of our principal properties as of December 31, 2025.
Location
Facility
Own/Lease (2)
Business Purpose
Parets del Vallès, Spain
Industrial Facility One Parets
66% owned; 34% of the property is leased from a third party
Plasma fractionation Manufacture of plasma derivatives & business unit support activities
Industrial Facility Two Parets
80% owned; 20% of the property is leased from a third party
Manufacture of Diagnostic and Healthcare Solutions products
Industrial Facility Three Parets
70% owned; 30% of the property is leased from a third party
Plasma storage & other operating activities
Los Angeles, California, U.S. – Valley
Industrial Facility, U.S.
92% owned; 8% of the property is leased from a third party
Plasma fractionation Plasma purification Manufacture of plasma derivatives
Los Angeles, California, U.S. – City of Industry
City of Industry, U.S.
100% leased
Plasma storage
Clayton, North Carolina, U.S.
Clayton Facility
100% owned
Durham, North Carolina, U.S.
Research Triangle Park
22% owned, 78% of the property is leased from a third party
Research and Development Labs and Offices
Emeryville, California, U.S.
Emeryville Facility
Manufacture of Diagnostic products
San Carlos, California, U.S.
Alkahest site
South San Francisco, California, U.S.
GigaGen site
Murcia, Spain
Industrial Facility Murcia
Manufacture of Healthcare Solutions products
Fribourg, Switzerland
Industrial Facility Switzerland
Melbourne, Australia
Industrial Facility Australia
Vista, California, U.S.
Grifols Bio Supplies, INC
Manufacture of Biological products
San Marcos, Texas, U.S.
Plasma Testing Lab
Plasma testing
San Diego, California, U.S.
San Diego Facility
75% owned; another 25% of the property is leased from a third party
Manufacture of components of the TMA amplified NAT kits
Dublin, Ireland
Global Operations Center
100% leased(1)
Operating activities related to the Biopharma business unit
Sant Cugat del Vallès, Barcelona, Spain
Headquarters
Derio, Bizkaia, Spain
Progenika Biopharma
90% owned, 10% leased
Manufacture of Diagnostic products & Research and Development
Zaragoza, Spain
Araclon Biotech
Boca Raton, Florida, U.S.
Grifols Bio Supplies, Inc
Specialty testing
Arrasate, Guipuzcoa, Spain
Kiro Grifols
Manufacture of Hospital equipment and Offices
Memphis, Tennessee, US
57% owned, 43% leased
Plasma Lab
Leipzig, Germany
Haema
Headquarters, Lab & Warehouse
Montreal, Canada
Industrial Facility Montreal
Plasma fractionation Plasma purification
Dreieich, Germany
Cairo, Egypt
Industrial Facility Dreieich
Industrial facility Cairo
86% owned, 14% leased
Joint venture with NSPO (49% owned by Grifols, 51% NSPO)
Plasma fractionation
Plasma Testing Laboratory Plasma Storage
(1)
We hold a 999 year leasehold interest in the property.
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(2)
Lease percentage based on property size.
Plasma Fractionation Plants
Our plasma derivative products are manufactured at our Parets, Los Angeles, Clayton and Dreieich facilities. All of our fractionation facilities have FDA and EMA certification. As of December 31, 2025, our facilities had an aggregate fractionation capacity sufficient to cover our current production needs.
The Parets facility has a unique design that separates the maintenance area from the clean areas required for the fractionation and purification procedures. This design, which we developed in-house, minimizes the risk of contamination and reduces maintenance costs. In addition to licenses from the European Union and other required specific authorities for the production of various plasma derivative products, the Parets facility is also licensed by the FDA. In addition to the plasma fractionation facilities, the Parets site also has protein purification, fill and finish, packaging, storage, research and development and energy co-generation facilities for the Biopharma business unit and manufacturing for the Diagnostic business unit and Healthcare Solutions business line. The Parets facility holds GMP’s, ISO 13485 and ISO 14001 for the Biopharma, Diagnostic and Healthcare Solutions plants and ISO 9001 certifications for its diagnostic manufacturing facilities.
In 2025, we began construction of a new plasma-fractionation plant in Lliçà de Vall (Barcelona, Spain), with a total planned investment of €160 million. We expect that this facility will enable us to double our fractionation capacity in Europe. The project will be integrated into the existing industrial complex in Parets, consolidating a biotechnology hub of approximately 25 hectares. The campus will include fractionation capacity, logistics, analytical laboratories, storage facilities, and a new space dedicated to Grifols Engineering. From an operational and environmental standpoint, the new plant has been designed as a highly digitalized and sustainable campus, with 100% of its electricity consumption covered by renewable sources, advanced monitoring systems, intelligent resource-management technologies, and energy-efficiency and circular-economy principles.
The Los Angeles facility contains purification and aseptic filling areas for coagulation factors, IG and albumin. The facility is licensed by the FDA and Grifols is working to certify the Los Angeles facility with ISO 14001 certification, similar to the rest of our manufacturing plants.
The Clayton facility in North Carolina is one of the world’s largest fully integrated facilities for plasma-derived therapies, including plasma receiving, fractionation, purification, filling/freeze drying and packaging capabilities, as well as freezer storage, testing laboratories and a cGMP pilot plant for clinical supply manufacture. This facility holds the ISO 14001 certification, which recognizes excellence and continuous improvement in environmental performance. The scope of the certification includes research, development, production and quality control of pharmaceutical specialties derived from human plasma.
In October 2020, we acquired our plasma fractionation facility (together with two purification facilities) in Montreal from GC Pharma. Once we finish renovations and obtain all necessary licenses and regulatory approvals for the Montreal facilities, we will become the only large-scale commercial manufacturer of plasma products in Canada. In 2025, the first phase was completed with the commissioning of an albumin purification and filling plant, and we started manufacturing albumin in the Montreal facilities. Phases II and III, currently under development, include the addition of a plasma-fractionation plant and a second IVIG purification and filling facility. We expect to begin plasma fractionation and gammaglobulin manufacturing by 2027.
We have an albumin purification, dosing and sterile filling plant in Dublin, Ireland. This plant allows a significant increase to our capacity for filling albumin in flexible packaging. Aligned with our measures to combat the effects of climate change, the Dublin plant has the latest eco-efficiency technologies to save energy and water.
In April 2022, we acquired the Dreieich facility as a result of the Biotest acquisition. The facility has plasma fractionation capabilities, as well as bulk production plants for albumin, new fibrinogen and IgM concentrate product lines and next-generation polyvalent immunoglobulins.
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Grifols Egypt, our joint venture with the NSPO, is currently building a new manufacturing site in Cairo that will feature fractionation and purification plants, logistics facilities and a plasma analysis lab to be fully automated. This project is designed to create a complete plasma value chain in Egypt, encompassing plasma donor recruitment, collection centers, laboratory testing, fractionation, purification, and final product manufacturing. Through this joint venture, Egypt achieved self-sufficiency in immunoglobulins, albumin, and coagulation factors in 2025, becoming the sixth country in the world to reach this level of autonomy in plasma-derived medicines. In addition, Grifols Egypt also currently owns 16 plasma-donation centers in Egypt (13 of which are already operating), with plans to expand to 20 in 2026.
Our facility in Dublin, Ireland, serves as a global operations center for our Biopharma business unit. This facility occupies 22,846 square meters and operates as the global supply chain management center for the Grifols Group. Our global operations center houses our Biopharma’s global logistics and distribution activities; warehousing of plasma, intermediate paste and finished product, labelling and secondary packaging of products; as well as regulatory and quality assurance activities relating to the supply of plasma and plasma derivatives. Finally, our Dublin facility also centralizes our treasury function and acts as our point of access to the capital markets.
Government Regulation
Government authorities in the United States and in other countries extensively regulate, among other things, the research, development, testing, approval, manufacturing, labeling, post-approval monitoring and reporting, packaging, promotion, storage, advertising, distribution, marketing and export and import of healthcare products such as those we collect, manufacture, sell or are currently developing. The process of obtaining regulatory approvals and complying with all applicable laws and regulations requires the expenditure of substantial time and financial resources. The following is a summary of the overall regulatory landscape for our business.
United States Government Regulation
In the United States, the FDA regulates drugs, biologics, plasma collection and medical devices under the FDCA and, as applicable, the PHS Act, and their implementing regulations. Failure to comply with the applicable FDA requirements at any time during the product-development process, approval process or after approval may result in administrative or judicial sanctions. These sanctions could include, as applicable, the FDA’s imposition of a clinical hold on trials for drugs, devices or biologics, refusal to file or approve pending applications, withdrawal of an approval, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties or criminal prosecution or any combination of these sanctions. Any agency or judicial enforcement action could have a material adverse effect on us.
The BLA (Biologics License Application) Approval Process
Drugs that are also biological products, such as our plasma derivative products IG, A1PI, Factor VIII and albumin, and also certain in vitro diagnostic products associated with testing blood and blood components, must also satisfy the requirements of the PHS Act (Public Health Service Act) and its implementing regulations. In order for a biological drug product, or for these in vitro diagnostic tests, to be legally marketed in the United States, the product must have a BLA (Biologics License Applications) approved by the FDA. Obtaining BLA approval from the FDA is a robust process involving, among other things, completion of preclinical laboratory tests, controlled human clinical trials conducted in compliance with Good Clinical Practice (GCP) requirements, submission of manufacturing and chemistry data, and multiple statistical and physical review processes by the FDA. During all phases of clinical development, regulatory authorities require extensive monitoring and auditing of all clinical activities, clinical data and clinical trial investigators, including reports regarding adverse events and safety issues.
Given the robust process, certain of our clinical trials may not be completed successfully within any specified period, if at all. Furthermore, we or the FDA may suspend or terminate clinical trials at any time on various grounds, for example, that the subjects or patients may be exposed to an unacceptable health risk, have experienced a serious and unexpected adverse event, or that continued use in an investigational setting may be unethical. Similarly, an IRB may suspend or terminate approval of research if the research is not being conducted in accordance with GMP or if the research has been associated with unexpected serious harm to patients.
Overall, the testing and approval processes require substantial time and effort and there can be no assurance that the FDA will accept the BLA for filing and, even if filed, that any approval will be granted on a timely basis, if at all. In most cases, the BLA must be accompanied by a substantial user fee.
In the United States, our main market, there is an abbreviated regulatory approval pathway for biological products found to be “biosimilar” to or “interchangeable” with a biological “reference product” previously licensed under a BLA. This abbreviated approval pathway is intended to permit a biosimilar product to come to market more quickly and less expensively by relying to some extent on the data generated by the reference product’s sponsor, and the FDA’s previous review and approval of the reference product. The law provides that no biosimilar application may be accepted for FDA review until four years after the date the reference product was first licensed by the FDA, and that the FDA may not make approval of an application effective until 12 years after the reference product was first licensed. The law also includes an extensive process for the innovator biologic and biosimilar manufacturer to litigate patent infringement, validity, and enforceability, which could increase costs of protecting our reference products. Once approved, biosimilars likely would compete with, and in some circumstances may be deemed under applicable laws to be “interchangeable with,” the previously approved reference product. The extent to which a biosimilar product, once approved, will be substituted for any of our products, in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing. In connection with the FDA’s authority to ensure the development of safe and effective biosimilars, in September 2022, the FDA Biosimilar User Fee Amendments of 2022 were signed into law. The FDA Biosimilar User Fee Amendments of 2022 reauthorize for an additional five years (through 2027) the Biosimilar User Fee Act of 2012, which allows the FDA to assess and collect fees for biosimilars. In October 2025, the FDA issued draft guidance that proposes to eliminate the need for sponsors of biosimilar products to conduct comparative human clinical efficacy studies.
The testing and approval processes to obtain a BLA require substantial time, effort and financial resources, and each process may take several years to complete. Data obtained from clinical activities is not always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. The FDA may not grant approval on a timely basis, or at all. We may encounter difficulties or unanticipated costs in our efforts to secure necessary governmental approvals, which could delay or preclude us from marketing our products. The FDA may limit the indications for use or place other conditions on any approvals that could restrict the commercial application of the products. In addition, competition from lower-priced biosimilars following loss of exclusivity may materially reduce sales.
Post-approval Requirements
After regulatory approval of a product is obtained, we are required to comply with a number of post-approval requirements. For example, as a condition of approval of a BLA, the FDA may require post-marketing testing and surveillance to monitor the product’s safety or efficacy. In addition, holders of an approved BLA are required to keep extensive records, to report certain adverse reactions and production problems to the FDA, to provide updated safety and efficacy information and to comply with requirements concerning advertising and promotional labeling for their products. Also, quality control and manufacturing procedures must continue to conform to cGMP regulations and practices, as well as the manufacturing conditions of approval set forth in the BLA. The FDA periodically inspects manufacturing facilities to assess compliance with cGMP, which imposes certain procedural, substantive and recordkeeping requirements. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance.
Future FDA inspections may identify compliance issues at our facilities or at the facilities of our third-party suppliers that may disrupt production or distribution, or require substantial resources to correct and prevent recurrence of any deficiencies, and could result in fines or penalties by regulatory authorities. In addition, discovery of problems with a product or the failure to comply with applicable requirements may result in restrictions on a product, manufacturer or holder of an approved BLA, including withdrawal or recall of the product from the market or other voluntary, FDA-initiated or judicial action that could delay or prohibit further marketing. Newly discovered or developed safety or efficacy data may require changes to a product’s approved labeling, including the addition of new warnings and contraindications.
The ACA established and provided significant funding for a Patient-Centered Outcomes Research Institute to coordinate and fund comparative effectiveness research. While the stated intent of comparative effectiveness research is to develop information to guide providers to the most effective therapies, outcomes of comparative effectiveness research could influence the reimbursement or coverage for therapies that are determined to be less cost effective than others.
Orphan Drug Designation
The FDA may grant orphan drug designation to drugs intended to treat a “rare disease or condition” that affects fewer than 200,000 individuals in the United States, or that affects more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such a disease or condition will be recovered from sales in the United States for that drug. Orphan drug designation must be requested before submitting an application for marketing approval. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. Orphan drug designation can provide opportunities for grant funding towards clinical trial costs, tax advantages and FDA user fee exemptions. In addition, if a product that has an orphan drug designation subsequently receives the first FDA approval for the indication for which it has such designation, the product is entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity or a meaningfully different mode of administration. Competitors may receive approval of different drugs or biologics for the indications for which the orphan product has exclusivity. However, if a company with orphan drug exclusivity is not able to supply the market, the FDA could allow another company with the same drug a license to market for said indication. The FDA granted Gamunex IVIG orphan drug status, which provided marketing exclusivity for the CIDP indication in the United States through September 2015. Gamunex IVIG was the first IVIG product approved for CIDP in the United States.
Fast Track Designation
The FDA currently offers certain programs, including fast track designation, breakthrough therapy designation, accelerated approval, and priority review which are designed to facilitate the development and review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs for the conditions. For example, fast track designation applies to a combination of the product and the specific indication for which it is being studied. The sponsor of a product designated for fast track designation may engage in close early communication with the FDA, including through timely meetings and feedback on clinical trials. Products that receive fast track designation also may receive FDA priority review or accelerated approval. Sponsors may also be able to submit completed portions of an application before the entire application is completed; however, the review clock will not officially begin until the entire completed NDA or BLA is submitted to and filed by the FDA. The FDA may notify a sponsor that its program is no longer classified as a fast track development program if the fast track designation is no longer supported by emerging data, the designated drug development program is no longer being pursued, or another product that meets the unmet medical need for the same indication is approved first.
Plasma Collection
The FDA requires a licensing and certification process for each plasma collection center prior to opening and conducts periodic inspections of facilities and processes. Many states also regulate plasma collection, imposing similar obligations and additional inspections and audits. Collection centers are subject to periodic inspections by regulatory authorities, which if noncompliance is alleged, may result in fines, citations, the temporary closing of the centers, loss or suspension of licenses or recall of finished products.
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Diagnostic Devices
Certain of our products are regulated as medical devices, which are typically subject to clearance for commercialization in the United States, often referred to as an FDA “510(k) clearance,” based on a pre-market notification to the FDA demonstrating the device to be marketed is safe and effective by proving substantial equivalence to a legally marketed device (predicate device). The manufacturers of medical devices must register their establishments with the FDA, and the production of the devices must accord with applicable current good manufacturing practices and quality system regulations. Some states also regulate the manufacture or distribution of certain medical devices, imposing additional licensing, inspection and audit requirements. With respect to the manufacture and sale of immunoassay antigens and antibodies to screen human donated blood and blood products, these products are manufactured and sold under a BLA issued by the FDA, and are subject to the heightened regulatory oversight associated with biological products.
Drug Supply Chain Security Act
The Federal Drug Quality and Security Act of 2013 regulates pharmaceutical supply chain requirements and pre-empts certain state laws. Title II of this act, known as the Drug Supply Chain Security Act (“DSCSA”) establishes a national electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States, including certain of our products. The DSCSA’s track and trace requirements (applicable to manufacturers, wholesalers, repackagers and dispensers (e.g., pharmacies) of prescription drugs) replaced the former FDA drug pedigree requirements and pre-empt state requirements that are inconsistent with, more stringent than, or in addition to, the DSCSA requirements. The DSCSA also establishes certain requirements for the licensing and operation of prescription drug wholesalers and third party logistics providers (“3PLs”), and includes the creation of national wholesaler and 3PL licenses in cases where states do not license such entities to be established in FDA regulations yet to be finalized. The DSCSA generally requires that wholesalers and 3PLs distribute drugs in accordance with certain standards regarding the recordkeeping, storage and handling of prescription drugs. Under the DSCSA, states are pre-empted from imposing any licensing requirements that are inconsistent with, less stringent than, directly related to, or covered by U.S. federal standards, however, the FDA has clarified that current state licensing requirements may remain in effect until the FDA national licensing regulations are finalized and take effect.
Anti-fraud and Abuse Regulation
Since we supply products and services that are reimbursed by U.S. federal healthcare programs such as Medicare and Medicaid, our activities are also subject to regulation by CMS (U.S. Centers for Medicare & Medicaid Services) and enforcement by the OIG (U.S. Office of the Inspector General). The federal Anti-Kickback Statute prohibits providers and others from directly or indirectly soliciting, receiving, offering or paying any remuneration with the intent of generating referrals or orders for services or items covered by a government health care program. Many states have similar laws. Courts have interpreted this law very broadly, including by holding that a violation has occurred if even one purpose of the remuneration is to generate referrals, even if there are other lawful purposes. There are statutory and regulatory exceptions, or safe harbors, that outline arrangements that are deemed lawful. However, the fact that an arrangement does not fall within a safe harbor does not necessarily render the conduct illegal under the Anti-Kickback Statute. In sum, even legitimate business arrangements between the companies and referral sources could lead to scrutiny by government enforcement agencies and require extensive company resources to respond to government investigations. Also, certain business practices, such as payment of consulting fees to healthcare providers, sponsorship of educational or research grants, charitable donations, interactions with healthcare providers that prescribe products for uses not approved by the FDA and financial support for continuing medical education programs, must be conducted within narrowly prescribed and controlled limits to avoid potential liability for wrongfully influencing healthcare providers to prescribe or purchase particular products or as a reward for past prescribing.
The FCA (Federal False Claims Act) is violated by any entity that knowingly presents or causes to be presented a false claim for payment to the U.S. federal government, or that knowingly makes or causes to be made a false record material to such a false claim, or knowingly conceals or avoids an obligation to pay to the government, including by knowingly retaining an overpayment. Payments in violation of the Anti-Kickback Statute can also form the basis for FCA liability.
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The FCA has been subject to heightened enforcement activity as a result of whistleblowers (called “relators”) who file complaints in the name of the United States (and if applicable, particular states), and who may receive up to 30% of total government recoveries. FCA violators may be liable for treble damages, mandatory penalties, loss of licensing and exclusion from federal and state healthcare programs. Such penalties could have a material adverse effect on our business. Also, these measures may be interpreted or applied by a prosecutorial, regulatory or judicial authority in a manner that could require us to make changes in our operations or incur substantial defense and settlement expenses. Even unsuccessful challenges by regulatory authorities or relators could result in reputational harm and the incurring of substantial costs. Most states have adopted similar state false claims laws, which could lead to significant additional penalties.
We also are subject to certain United States and foreign laws and regulations concerning the conduct of our foreign operations, including the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act, German anti-corruption laws and other anti-bribery laws and laws pertaining to the accuracy of our internal books and records, which have been the focus of increasing enforcement activity globally in recent years.
The “PPS Act” (Physician Payments Sunshine Act) imposes reporting and disclosure requirements for biologic, drug and device manufacturers with regard to payments or other transfers of value made to physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, certified nurse-midwives, teaching hospitals, manufacturers and for GPOs (group purchasing organizations), with regard to practitioner and teaching hospital ownership interests in the reporting entity. CMS publishes information from these reports on a publicly available website, including amounts transferred and practitioner and teaching hospital identities. The PPS Act preempts similar state reporting laws, although we or our subsidiaries may also be required to report under certain state transparency laws that address circumstances not covered by the PPS Act, and some of these state laws, as well as the federal law, can be ambiguous. We are also subject to foreign regulations requiring transparency of certain interactions between suppliers and their customers.
Other Health Care Regulation
In the United States, pricing concerns have led to heightened scrutiny and ongoing governmental efforts to increase transparency around healthcare and pharmaceutical drugs costs. For example, on November 12, 2020, CMS issued final rules imposing price transparency requirements on hospitals and group health plans, which went into effect in three stages from 2022 to 2024. As of January 1, 2024, hospitals and group health plans must disclose in-network provider negotiated rates (which include rates with device suppliers and manufacturers), historical out-of-network allowed amounts for all covered items and services, including all prescription drugs and drug pricing information. States have also enacted a variety of transparency rules and regulations. The publication of our negotiated rates could affect our ability to independently negotiate sales contracts and rate agreements.
Another notable Medicare healthcare reform initiative, the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”), established a new quality payment program, which modifies certain Medicare Part B payments to “eligible clinicians,” including physicians, dentists and other practitioners. Under MACRA, certain eligible clinicians are required to participate in Medicare through the Merit-Based Incentive Payment System (“MIPS”) or the Advanced Alternative Payment Models (“APMs”), through which Medicare Part B reimbursement is adjusted up or down based on reported data related to quality, promoting interoperability, cost, and improvement activities. MIPS-eligible clinicians must report annual performance data by March 31 of the following year. Payment adjustments based on submitted data are applied to Medicare Part B claims during the performance year following data submission. MACRA provides substantial financial incentives for physicians to participate in risk contracts, while increasing physician information technology and reporting obligations. MACRA continues to evolve and its implications depend on future regulatory activity and physician activity in the marketplace. New payment and delivery system reform programs, including those modeled after such federal program, are also increasingly being rolled out at the state level through Medicaid administrators, as well as through the private sector, which may further alter the marketplace and impact our business.
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Recently, a number of states in the United States have also proposed or passed legislation that seeks to directly or indirectly regulate pharmaceutical drug pricing, such as by requiring drug manufacturers to publicly report pricing information or to place a maximum price cap on pharmaceutical products purchased by state agencies. For example, in June 2024, New York implemented a prescription drug price transparency law that requires prescription drug manufacturers to provide advance notice and explanation for certain drug price increases that exceed a specified threshold. California, Colorado, Minnesota, Oregon, Washington and New Jersey have created prescription drug affordability boards, and a number of other states have enacted or are considering similar legislation. Laws of this type may cause us to experience additional pricing pressures on our affected products. For more details on these pressures, see “—Pharmaceutical Pricing and Reimbursement” below.
Antitrust and Consumer Protection
The U.S. federal government, most U.S. states and many foreign countries have antitrust laws that prohibit certain types of conduct deemed to be anti-competitive, as well as consumer protection laws that seek to protect consumers from improper business practices. At the U.S. federal level, the FTC oversees enforcement of these types of laws, and states have similar government agencies. Violations of antitrust or consumer protection laws may result in various sanctions, including criminal and civil penalties. Private plaintiffs may also bring civil lawsuits against us in the United States for alleged antitrust law violations, including claims for treble damages.
European Community Government Regulation
In addition to regulations in the United States, we are subject to a variety of regulations in other jurisdictions governing clinical trials and commercial sales and distribution of our products. Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of countries outside the United States before we can commence marketing that product in those countries. The approval process varies from country to country, and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country. Also, in addition to approval of final products, plasma collection centers for manufacture into products to be distributed in the European Union must also be approved by the competent European health authority.
Medicines can be authorized in the European Union by using either the centralized authorization procedure or national authorization procedures. The EMA is responsible for the centralized authorization procedure.
Centralized Authorization Procedure
The EMA is responsible for the centralized procedure, or Community authorization procedure, for human medicines. This procedure results in Community marketing authorization, the single marketing authorization that is valid across the European Union, as well as in the European Economic Area/European Free Trade Association states Iceland, Liechtenstein and Norway.
The Community authorization procedure is compulsory for:
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The Community authorization procedure is optional for products:
Our blood derivative products are not subject to compulsory Community authorization, but it is an option for our new products. Flebogamma DIF 50 mg/ml and 100 mg/ml, VeraSeal solutions for sealant and Tavlesse (fostamatinib) were approved through the Community authorization procedure.
Applications through the Community authorization procedure are submitted directly to the EMA. Evaluation by the EMA’s relevant scientific committee takes up to 210 days, at the end of which the committee adopts an opinion on whether the medicine should be marketed. This opinion is then transmitted to the European Commission, which has the ultimate authority for granting marketing authorizations in the European Union.
Once a Community marketing authorization has been granted, the holder of that authorization can begin to make the medicine available to patients and healthcare professionals in all European Union countries.
National Authorization Procedures
Each European Union member state has its own procedures for the authorization, within its own territory, of medicines that fall outside the scope of the Community authorization procedure. There are two possible routes available to companies for the authorization of such medicines in several countries simultaneously.
Our products Niuliva 250 I.U./ml and Xembify 200 mg/ml were approved through the decentralized procedure. Our products Prolastina 1000 mg/ml, and Gamunex 10% and some of the Human Albumin Grifols / Albutein licenses were approved through the mutual-recognition procedure. All our other products were approved pursuant to individual national procedures. We expect to use the mutual-recognition procedure if we want to extend our product licenses to other European countries in the future.
In some cases, disputes arising in these procedures can be referred to the EMA for arbitration as part of a “referral procedure.”
Applications for designation of orphan medicines are reviewed by the EMA through the Committee for Orphan Medicinal Products. The criteria for orphan designation are:
Companies with an orphan designation for a medicinal product benefit from incentives such as:
Orphan medicinal products are eligible for the following level of fee reductions:
We have EMA Orphan Drug Designations for the following products:
Because each of these products is already authorized for a non-orphan indication in the EU, in order to obtain marketing authorization for any of the above-mentioned orphan indications, we would be required to apply for a separate marketing authorization through the Community authorization procedure for such indication, using a different proprietary name. It is not possible to extend the existing marketing authorization to cover the new orphan indication. Orphan and “non-orphan” indications cannot be covered by the same marketing authorization.
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United Kingdom Regulatory Process
The United Kingdom (“U.K.”) withdrew from the E.U. on January 31, 2020, and is no longer an E.U. Member State. A transition period, during which E.U. pharmaceutical law continued to be applicable to the U.K., ended on December 31, 2020.
As of January 1, 2021, the protocol in Ireland/Northern Ireland was applicable and had an impact on marketing authorizations for medicinal products in the U.K. with respect to Northern Ireland. However, as of January 1, 2025, a new agreement between the E.U. and the U.K. called the “Windsor Framework” amended the Protocol of Northern Ireland and set out the long-term arrangements for the supply of medicines into Northern Ireland. The Windsor Framework ensures that medicines can be approved and licensed on a U.K.-wide basis by the Medicines and Healthcare products Regulatory Agency (“MHRA”) and medicines can be supplied in the same packs across the U.K. It also provides for the disapplication of European Union Falsified Medicines Directive (“FMD”) requirements for medicines marketed and supplied in Northern Ireland.
There are several routes to obtain a marketing authorization in the U.K. The options available are determined by the intended market and the type of application. To obtain a marketing authorization, you need to use one of the following procedures:
National Routes:
This rolling review is intended to streamline the development of novel medicines by offering periodic enhanced regulatory interaction and advice to reduce the risk of failure at the final phase and may be integrated with the Target Development Profile (“TDP”) to provide a clearer pathway for development of innovative medicines.
Marketing authorization applications for any new active substance based on a “full dossier,” including biosimilar products, are eligible for the rolling review;
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This route is available for marketing authorizations approved in Northern Ireland via European procedures (MR or DC procedures only).
Applications should include the dossier as approved for marketing in Northern Ireland, accompanied by all iterations of the relevant RMS assessment reports.
International routes (collaborative procedures):
Further information can be found in the U.K.’s website for license applications (www.gov.uk).
Canadian Regulatory Process
Authorization to Market. In 2024, Health Canada implemented several regulatory modernization initiatives to streamline product approvals and enhance responsiveness to public health needs. Notably, in November 2024, Health Canada introduced the Agile Licensing Framework, amending the Food and Drug Regulations (“FDR”) and Medical Devices Regulations (“MDR”). These amendments expand Health Canada’s authority to impose terms and conditions on market authorizations and formalize the use of rolling reviews to facilitate earlier access to promising therapies. Therapeutic products can be marketed in Canada after they have been subject to a review to assess their safety, efficacy and quality. A New Drug Submission must be submitted to Health Canada for review, and a Notice of Compliance (“NOC”), and/or a Drug Identification Number (“DIN”), must be received by the sponsor prior to marketing a product in Canada. Responsibility for review of pharmaceutical drug products resides with Health Canada’s Therapeutic Products Directorate (“TPD”), while responsibility for review of biological products is under the Biologics, Radiopharmaceuticals and Genetic Therapies Directorate (“BGTD”). An active DIN is required for any product being marketed in Canada. Our IG, A1PI, albumin and hyperimmune products are subject to these review and authorization processes.
Changes to Market Authorization. There are four classes of changes to existing market authorizations in Canada. Level 1 changes are considered “significantly different” and have the potential to impact safety, efficacy, quality or effectiveness of the product. These require the filing of a Supplemental New Drug Submission, and a NOC must be issued by Health Canada prior to implementation of the change. Level 2 changes are not considered “significant,” but a “Notifiable Change” submission must be filed to Health Canada for review, and approval is provided via a “No Objection” letter to the sponsor. Level 3 changes have minimal potential to impact safety, quality or effectiveness and can be made without prior approval of Health Canada; a summary of these changes is reported to Health Canada with the sponsor’s Annual Drug Notification. Level 4 changes are implemented without any notification to Health Canada, based on no expectation of risk.
Shortage Management. In December 2024, Health Canada proposed amendments to the FDR and MDR to strengthen its authority to manage drug and medical device shortages. If adopted, these amendments will require market authorization holders to report shortages, discontinuations, and unexpected surges in demand, enabling Health Canada to respond more proactively to supply risks.
Clinical Trials. A Clinical Trial Application (“CTA”), must be submitted to Health Canada prior to conducting any study protocol that proposes the use of a new product, or the use of an existing product, where the indication, target population, route of administration or dosing differs from the current market authorization. The CTA should include summaries of preclinical and clinical studies conducted and (if applicable) chemistry, manufacturing and control data, and is submitted to either TPD (for drug products) or BGTD (for biological products) for review. The TPD or BGTD are responsible for assessing protection and safety of the participants as well as quality of the product; they will issue a “No Objection” letter to sponsors for studies deemed acceptable. Research ethics board approval for each trial is also required prior to conduct of the study.
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Establishment Licensing. All establishments in Canada that are involved in the fabrication, packaging/labeling, testing, import, distribution or warehousing of drug products must have a current establishment license (once an establishment license is issued, an annual report must be submitted by April 1 of each year to maintain the effectiveness of that license). As an importer/distributor, part of the licensing requirements include demonstration that any foreign (non-Canadian) facilities involved in fabrication, packaging/labeling or testing of products imported/distributed under the license comply with cGMP.
Post-Approval Requirements. In December 2024, Health Canada amended the regulatory framework governing product recalls, introducing mandatory reporting obligations to enhance oversight and response capabilities. The Health Products and Food Branch Inspectorate continues to inspect licensed establishments for cGMP compliance. Adverse drug reactions must be reported in accordance with Health Canada’s pharmacovigilance requirements to the Marketed Health Products Directorate.
Regulatory Coordination. As of May 1, 2024, the CADTH transitioned into Canada’s Drug Agency (“CDA”). The CDA now plays a broader role in coordinating national drug policy, providing evidence-based evaluations of health technologies and therapeutics, and advising public payers on funding decisions.
Regulatory Process for Markets outside the United States, Europe, United Kingdom and Canada
The majority of regulatory authorities in countries outside the United States, Canada and Europe require that a product first be approved by the FDA or European authority prior to granting the market authorization in their country. There are a limited number of countries (Bahamas, Bermuda, Guam, Oman and Qatar) that do not require further local product registration for products and they may be distributed based on the existing FDA approval.
In addition to requiring the submission of a license application containing documentation supporting the safety, efficacy and quality of the product, many countries require the submission of FDA Export Certificates for our products to provide assurance that such products can be legally marketed in the United States. The Certificate of Pharmaceutical Product (“CPP”), and/or the Certificate to Foreign Government (“CFG”), are issued by the FDA at the request of the manufacturer seeking licensing in the country outside the United States. The CPP conforms to the format established by the World Health Organization (“WHO”), and is intended for use by the importing country when considering whether to license the product in question for sale in that country. The CFG serves to document that the product can be legally marketed in the United States and the manufacturer is in compliance with GMP. A limited number of regulatory authorities in countries outside United States, Canada and Europe conduct onsite inspections to verify GMP compliance. Failure to maintain and document GMP compliance could result in withdrawal of marketing authorization. In addition changes to manufacturing or testing procedures for the product require approval of the change in the United States prior to the submission of the variation to the registration in the international market. These changes may require approval in each market in order to maintain product distribution. Furthermore, any changes in the distributors supporting our export business could result in a loss of sales.
Pharmaceutical Pricing and Reimbursement
In the United States and other countries, sales of our products depend, in material respects, on the availability of reimbursement from third-party payors. Third-party payors include government health programs, managed care providers, private health insurers and other organizations. These third-party payors are increasingly challenging the prices and examining the cost-effectiveness of medical products and services. In addition, significant uncertainty exists as to the reimbursement status of healthcare products newly approved by regulatory authorities. For example, third-party payors may deny reimbursement if they do not consider the products to be cost-effective as compared to available alternative products. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.
United States Pharmaceutical Pricing and Reimbursement
In the United States, our products are reimbursed or purchased under several government programs, including Medicaid, Medicare (Parts B and D) and hospitals may purchase at discounted prices under the 340B Program. Medicaid is a joint state and federal government health plan that provides covered outpatient prescription drugs for low income individuals. Medicare is a federally run program that provides healthcare to persons aged 65 and over, as well as certain persons of any age with certain disabilities. The 340B Program is a U.S. federal government drug pricing program under the PHS Act. The availability of federal funds to pay for our products under the Medicaid and Medicare Part B programs requires that we extend discounts under the 340B Program.
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Medicaid, the 340B Program and the Department of Veterans Affairs.
Medicaid includes a variety of reimbursement programs that differ state by state and imposes reimbursement requirements applicable to both fee-for-service and managed care arrangements. These requirements are applicable to certain of our products. Under Medicaid, drug manufacturers pay rebates to the states based on utilization data provided by the states and pricing information provided by manufacturers, such as AMP (average manufacturer price) and the lowest price available from the manufacturer during the rebate period to any entity in the United States in any pricing structure in the same quarter for which the AMP is computed (“Best Price”). The states share the rebates with the U.S. federal government. The rebate amount for most brand name drugs is the greater of 23.1% of the AMP per unit or the difference between the AMP and Best Price per unit as adjusted by the U.S. Consumer Price Index for All Urban Consumers (“CPI-U”), subject to certain exceptions. For example, the rebate amount for certain clotting factors such as Factor VIII and Factor IX is the greater of 17.1% of the AMP per unit or the difference between the AMP and the Best Price per unit as adjusted by the CPI-U, and the rebate amount for non-innovator multiple source (generic) drugs is equal to a minimum of 13.0% of AMP.
The availability of federal funds to pay for our products under Medicaid requires that we extend discounts under the 340B Program. The 340B Program extends prescription drug discounts to certain entities, including a variety of community health clinics and certain other entities that receive governmental health care grants, as well as hospitals that serve a disproportionate share of low income individuals, certain cancer centers, children’s hospitals, critical access hospitals and rural referral centers. The 340B Program prescribes a pricing methodology based on a PHS Act ceiling price that generally cannot be greater than the AMP less the unit rebate amount established under the Medicaid drug rebate program. We have entered into a PPA with the government whereby we participate in the 340B Program by charging eligible entities no more than the PHS Act ceiling price for drugs intended for outpatient use. The HRSA (Health Resources & Services Administration) of the HHS, the federal agency overseeing the 340B Program, continually issues evolving requirements with respect to the 340B Program, which creates uncertainty. For example, in February 2026, HRSA officially withdrew its 340B Rebate Model Pilot Program and subsequently issued a request for information seeking comments on launching a new 340B Program rebate model.
Also as a condition for Medicaid reimbursement, we make our products available for purchase by authorized government users of the Federal Supply Schedule (“FSS”) pursuant to such users’ FSS contracts with the Department of Veterans Affairs. These transactions involve establishing a FSS price in negotiation with the Department of Veterans Affairs. Companies are also required to offer discounted drug pricing to four federal agencies — the Department of Veterans Affairs, the Department of Defense, the Coast Guard and the PHS (including the Indian Health Service) — for federal funding to be made available for reimbursement of products under the Medicaid program. Sales to those four federal agencies must utilize a ceiling price methodology that generally requires drug prices to be at least 24.0% below the non-federal AMP for the prior fiscal year.
Medicare and the 340B Program.
The primary Medicare programs that may affect reimbursement for the Grifols Group are Medicare Part B, which covers physician services and outpatient care, and Medicare Part D, which provides a voluntary outpatient prescription drug benefit.
Medicare Part B reimburses providers for certain covered drugs and biologicals furnished in the outpatient setting, such as physician offices and hospital outpatient settings, generally at a rate of average sales price (“ASP”) + 6%. Starting January 1, 2018 a CMS rule reduced Medicare Part B reimbursement for 340B hospital outpatient drugs to a rate of ASP - 22.5%. Such reduction was ruled unlawful by the U.S. Supreme Court on June 15, 2022, causing CMS to reinstate the general ASP + 6% rate retroactively to January 1, 2018. Following this ruling, CMS issued a new rule on November 8, 2023 determining that affected hospitals will receive a one-time lump-sum amount plus a budget-neutrality offset going forward, which together equal the approximate payment they would have received if the 2018-2022 340B Program payment policy had never existed. The 340B Program remains subject to legal challenges involving litigation that may result in program changes, which creates uncertainty. We believe that we meet the requirements of the 340B Program and are continuing to review and monitor these and other developments affecting the 340B Program. In addition, under the Bipartisan Budget Act of 2013 and subsequent measures, Medicare is subject to a 2% reduction in federal spending, or “sequestration,” including drugs reimbursed under Medicare, for federal fiscal years 2013 through 2032. The full ramifications of this sequestration for Medicare reimbursement remain uncertain, as further Congressional action may reduce, eliminate or otherwise change this payment reduction.
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Medicare Part D coverage is administered through private insurers that contract with CMS. To obtain payments under this program, which covers certain of our products, we are required to negotiate prices with private insurers operating pursuant to federal program guidance, and these prices may be lower than we might otherwise obtain. In addition, the Medicare Part D Program had included a coverage gap feature, where once beneficiaries had expended certain amounts for drugs payable under Medicare Part D, Medicare Part D benefits were decreased for a period until certain levels of out-of-pocket spending were incurred by such beneficiaries. Pursuant to this coverage gap, drug manufacturers were required to provide a 70% discount (the “Coverage Gap Discount”) for certain drugs falling within a beneficiary’s coverage gap. However, as of January 1, 2025, under the federal Inflation Reduction Act of 2022, CMS eliminated the coverage gap design and Coverage Gap Discount, and implemented a “Manufacturer Discount Program” under which, after beneficiaries meet their Medicare Part D deductible, drug manufacturers generally must provide discounts of 10% on applicable drugs during an initial coverage phase and 20% during a catastrophic coverage phase. Because this new design is expected to decrease Medicare beneficiaries’ out-of-pocket costs, manufacturers’ share of those costs may increase. Consequently, our net revenue, beginning in 2025, may be adversely affected.
Additionally, the Inflation Reduction Act of 2022 provides Medicare, for the first time, with the ability to negotiate drug prices directly with drug manufacturers to determine the price Medicare will pay for certain drugs covered under Medicare Part D (effective as of 2026) and Medicare Part B (effective as of 2028). Certain drugs are excluded from the negotiation process, such as drugs with an orphan designation as their only FDA-approved indication and certain plasma-derived drugs. To the extent our drugs fall within any of the aforementioned excluded categories, Medicare would not have the ability to negotiate our prices for those drugs. Manufacturers that fail to comply with program requirements may be subject to civil monetary penalties and excise taxes.
Also under the Inflation Reduction Act of 2022, if a manufacturer increases the prices generally for brand name prescription drugs and biologicals covered under Medicare Part B or certain drugs and biologicals covered under Medicare Part D, in each case at a higher rate than the applicable inflation rate for such products, then such manufacturer will be required to pay rebates to Medicare. If our products are used by Medicare beneficiaries, we will be required to pay rebates to Medicare or potentially face fines representing the difference between the actual and the inflated prices. And, beginning in 2025, this law modifies a manufacturer’s liability relating to Medicare’s spending above a beneficiary’s out-of-pocket cap. In a December 13, 2023 guidance document, CMS generally outlined its calculation methodologies and processes, including certain adjustments (such as in the event of drug shortages, with, for example, certain greater reductions provided for plasma-derived products). CMS issued final rulemaking for the Medicare Prescription Drug Inflation Rebate Program on November 1, 2024, including to codify these programs. Beginning in 2025, CMS issued the first round of invoices to drug manufacturers for these rebates, including for years 2022, 2023 and 2024. Manufacturers’ failure to timely pay a rebate amount due may result in the imposition of civil monetary penalties. We are continuing to review and monitor these new Inflation Reduction Act programs under Medicare, which create uncertainty and may adversely affect our business.
Other Relevant Regulations.
The ACA imposes an annual fee on certain manufacturers and importers of branded prescription drugs and biologics in general if the entity has aggregated branded prescription drug and biologic sales of over $5 million to specified United States government health programs such as the Department of Veteran Affairs, or pursuant to coverage under such specified government health programs, such as Medicare Part B, Medicare Part D and Medicaid. The fee to each covered entity generally is calculated as an allocated portion of an aggregate amount of branded sales attributed to all covered entities, which aggregate amount is subject to change. Since 2019, the aggregate annual fee amount has been $2.8 billion. In addition, the Prescription Drug User Fee Act (“PDUFA”) sets forth user fees that pharmaceutical and biological companies pay to the FDA for certain applications for approvals of drugs and biologicals, licensing of certain biological products, and certain prescription drug program fees assessed annually for eligible products. The fees under PDUFA cover a substantial portion of the FDA’s operating budget, and the measure also addresses aspects of the regulatory approval process, such as timing and procedures. The PDUFA is subject to reauthorization by Congress every five years and, in September 2022, the FDA User Fee Reauthorization Act of 2022 was signed into law, reauthorizing the PDUFA for fiscal years 2023 through 2027.
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Federal, state and local governments in the United States have enacted and continue to consider additional legislation to limit the growth of healthcare costs, including the costs of prescription drugs. In May 2025, the United States government issued an executive order directing the HHS to facilitate direct-to-consumer purchasing programs for prescription drug manufacturers that sell their products to American patients at the most-favored-nation price and to communicate most-favored-nation price targets to manufacturers and propose a rulemaking plan to impose most-favored-nation pricing if “significant progress” is not made towards achieving such pricing. For example, in May 2025, the United States government issued an executive order aiming to implement “most-favored-nation” pricing tying U.S. prescription drug prices with prices in selected comparably developed nations. In July 2025, several pharmaceutical companies received letters from the United States government seeking commitments to advance such “most-favored-nation” drug pricing goals. In addition, CMS’s proposed Global Benchmark for Efficient Drug Pricing (GLOBE) and Guarding U.S. Medicare Against Rising Drug Costs (GUARD) models would assess a rebate for certain drugs payable under Medicare Part B and Part D.
An increasing number of states in the United States have also proposed or passed legislation that seeks to directly or indirectly regulate pharmaceutical drug pricing, such as by requiring drug manufacturers to publicly report pricing information or to place a maximum price ceiling on pharmaceutical products purchased by state agencies. For example, in June 2024, New York implemented a prescription drug price transparency law that requires prescription drug manufacturers to provide advance notice and explanation for certain drug price increases that exceed a specified threshold. Laws of this type may cause us to experience additional pricing pressures on our affected products, and could adversely affect our business.
Furthermore, the marketability of any products for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and reimbursement. Existing and future legislation could limit payments for our existing products or for drug candidates that we are developing, including possibly permitting the federal government to negotiate prices directly with manufacturers. This increasing emphasis on managed care in the United States has increased and will continue to increase the pressure on pharmaceutical pricing. For a discussion of certain risks related to reimbursement and pricing, see Item 3 of this Part I, “Key Information—D. Risk Factors—Risks Relating to the Healthcare Industry—United States Healthcare Reform may adversely affect our business.”
European Union Pharmaceutical Pricing and Reimbursement
Our operations in the E.U. are subject to strong regulations affecting the pricing of and market access to our products. Ministries of Health (MoH) across E.U. Member States oversee the price of pharmaceutical products through cost containment measures applied to national healthcare systems. As such, over the last decades, governments in the E.U. Member States have been introducing severe Health Economics and Outcomes Research (“HEOR”) criteria, a multidisciplinary field that studies the economic, clinical and societal impact of healthcare interventions, to limit increases in costs, particularly with respect to innovative prescription drugs.
HEOR criteria are implemented by Health Technology Assessment (HTA) organizations on a national basis, a process that evaluates the effects and impacts of health technologies and interventions to inform policy and decision-making in healthcare, and include cost-effectiveness analysis, budget impact models and additional clinical benefits versus existing marketed (or in development) drugs used as benchmarks for comparison, with the objective to appraise the value proposition and determine the price and reimbursement levels. E.U. Member States also seek to limit healthcare expenditure by passing legislation and health policies to impose mandatory rebates for pharmaceutical products and financial claw-backs to the pharmaceutical industry, as well as International Reference Pricing (“IRP”), a cost-control mechanism where a country benchmarks its drug prices to those in other countries either applying the lowest or average calculation among a basket of selected countries. We expect that E.U. Member States will continue to pursue actions to reduce healthcare expenditures in the upcoming years.
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Pricing and Reimbursement in Other Countries
Many countries around the world have been taking steps to control healthcare costs, particularly as they relate to prescription drugs. For example, in Asia, pharmaceutical pricing and reimbursement regulations vary significantly across countries, reflecting diverse healthcare infrastructures and economic conditions. In China, the government has implemented several reforms to control drug prices and improve access. The National Healthcare Security Administration (“NHSA”) oversees the centralized procurement of drugs, which has led to significant price reductions for many medications. In India, the National Pharmaceutical Pricing Authority (“NPPA”) regulates drug prices to ensure medicines remain affordable. The NPPA enforces the “Drug Price Control Orders,” which set ceiling prices for essential medicines based on factors like production costs and market competition.
Australia’s Medical Services Advisory Committee (“MSAC”) also uses a HTA framework to assess applications for public funding, including: (i) a PICO (population, intervention, comparator, outcome) to describe the population, intervention, comparator and outcome for the health service or technology; (ii) an assessment report (developed by the applicant or an HTA group) to review the clinical evidence and conduct HEOR evaluations of the service or technology; (iii) an independent critique (commentary) of applicant-developed assessment reports; and (iv) consultation input from stakeholders. Recently, patient groups have also been invited to provide feedback in the frame of a more patient-centric approach.
Japan’s healthcare fees are administered on a fee-for-service (“FFS”) basis, in which the provider calculates reimbursements based on the number of points allocated for each item and is then reimbursed for the service or product based upon the number of points. The Japanese payment system (diagnosis procedure combination, or “DPC”) is similar to the diagnosis related groups (“DRG”) prospective payment system (“PPS”) found in the U.S. and in some European countries. Although DPC has not resulted in lower costs due to its unique mix of PPS with FFS, there is strong opposition against further integration of PPS.
In Latin America, countries employ diverse strategies to regulate pharmaceutical pricing and reimbursement, often combining direct price controls with reference pricing systems. In Brazil, the Chamber for Regulation of the Medicines Market (“CMED”) sets maximum prices for medications considering factors such as production costs and economic evaluations. In Argentina, the government also implements direct price controls, negotiating prices with pharmaceutical companies to maintain affordability. These are examples of countries utilizing reference pricing systems, benchmarking drug prices against those in other nations to ensure competitiveness and prevent excessive pricing, a practice that is used in many jurisdictions globally.
In Canada, pharmaceutical pricing and reimbursement are governed by a combination of federal oversight and provincial/territorial collaboration. The Patented Medicine Prices Review Board (“PMPRB”) is a federal agency responsible for ensuring that prices of patented medicines are not excessive. It establishes maximum allowable prices by reviewing factors such as the prices of similar drugs in Canada (Internal Reference Pricing rule) and internationally (International Reference Pricing). The pan-Canadian Pharmaceutical Alliance (“pCPA”) negotiates drug prices on behalf of public drug plans across provinces and territories, aiming to achieve consistent and lower drug costs. Furthermore, the Canadian Agency for Drugs and Technologies in Health (“CADTH”), now renamed Health Technology Review, conducts health technology assessments, including clinical and economic evaluations, to inform reimbursement decisions for most public drug plans in Anglophone Canada, whereas in Francophone Canada the responsible body for HTA of pharmaceutical products is Institut National d’Excellence en Santé et en Services Socieux (“INESSS”).
Item 4.A.UNRESOLVED STAFF COMMENTS
Item 5.OPERATING AND FINANCIAL REVIEW AND PROSPECTS
The following is a review of our financial condition and results of operations as of December 31, 2025 and 2024, and for the three years ended December 31, 2025, and of the key factors that have affected or are expected to be likely to affect our ongoing and future operations. You should read the following discussion and analysis in conjunction with our audited consolidated financial statements and the accompanying notes included elsewhere in this annual report on Form 20-F.
Some of the information contained in this discussion, including information with respect to our plans and strategies for our business and our expected sources of financing, contain forward-looking statements that involve risk and uncertainties. You should read “Cautionary Statement Regarding Forward-Looking Statements” in this Part I for a discussion of the risks related to those statements. You should also read Item 3 of this Part I, “Key Information—D. Risk Factors” for a discussion of certain factors that may affect our business, financial condition and results of operations.
We have prepared our audited consolidated financial statements as of December 31, 2025 and 2024, and for the three years ended December 31, 2025 in accordance with IFRS, as issued by the IASB. The financial information and related discussion and analysis contained in this item are presented in euros except as otherwise specified. Unless otherwise specified the financial information analysis in this annual report on Form 20-F is based on our actual audited consolidated financial statements as of December 31, 2025 and 2024, and for the three years ended December 31, 2025.
See “Presentation of Financial and Other Information” in this Part I for further information on our presentation of financial information.
Subsequent Events
Potential U.S. Biopharma IPO
Following approval by our Board, on March 24, 2026 we announced that we will potentially pursue an initial public offering of a minority stake in our U.S. Biopharma business, subject to market conditions and applicable legal and regulatory requirements. The transaction is intended to support our strategic priorities, including debt reduction and investment in growth initiatives. Upon completion, Grifols S.A. would retain control of the U.S. business and remain listed in Spain, while the U.S. Biopharma entity would operate as a separately governed, U.S.-listed company with its own board and management team.
Repayment of EIB Term Loans
On March 16, 2026, we prepaid in full the outstanding amounts owed under the 2017 EIB Term Loan and 2018 EIB Term Loan, resulting in the termination of the EIB Term Loans. We are currently negotiating with the EIB the execution of the corresponding documentation for the cancellation of the security interest and guarantees granted in favor of the EIB to secure/guarantee the EIB Term Loans.
Joint Business Arrangements with Ortho
Our joint business arrangement with Ortho (QuidelOrtho), initiated over 40 years ago and originally focused on the development and production of HIV and HCV antigens, was terminated effective January 1, 2026, pursuant to a Settlement and Termination Agreement executed on April 11, 2026, as both businesses and the relevant market have significantly evolved over time. We agreed on a settlement amount of $65.0 million to be paid by QuidelOrtho to us as a final and comprehensive settlement of all matters arising from the termination: $25.0 million in Q2 2026, $25.0 million in Q1 2027, and $15.0 million in Q1 2028. Concurrently, we entered into a new multi-year Exclusive Supply Agreement with Ortho under which we continue as exclusive supplier of antigens to Ortho, while retaining the right to supply antigens to third parties (including Abbott Laboratories, Siemens and OraSure Technologies) and to develop products independently, subject to customary intellectual property terms.
Refinancing of a portion of our senior secured debt
Subsequent to December 31, 2025, we continued to advance our plans to proactively refinance our senior debt maturing in 2027. On April 14, 2026, we entered into a new credit agreement with a syndicate of banks whereby such banks have agreed to extend certain credit facilities consisting of term loans of $2 billion and €1.25 billion, both maturing in April 2033, as well as a revolving credit facility of $2.065 billion, maturing in October 2032 (subject to a springing maturity if certain material indebtedness is not refinanced in advance of its maturity). The proceeds of the term loans are being used to fully repay the outstanding loans under the First Lien Credit Facilities and certain other debt. See Item 5 of this Part I, “Operating and Financial Review and Prospects—B. Liquidity and Capital Resources—Sources of Credit—New Credit Facilities.”
Changes in Board of Directors
Effective January 2026, (i) Ms. Laura de la Cruz Galan was appointed as Secretary non-member of the Board, replacing Mrs. Núria Martín Barnés, and (ii) Mrs. Núria Martín Barnés was appointed as Vice-secretary, non-member, of the Board, taking the role previously held by Ms. Laura de la Cruz Galán. See Item 6 of this Part I, “A. Directors and Senior Management—Directors.”
Factors Affecting Our Financial Condition and Results of Operations
Changes in accounting criteria and correction
In the consolidated financial statements for fiscal year 2024, the Group applied certain corrections related to the accounting classification of the joint operation Biotek America LLC and the initial treatment of the investment in Shanghai RAAS. These corrections affected the comparative figures for fiscal years 2022 and 2023 and were described in detail in the notes to the 2024 financial statements. The consolidated financial statements for 2025 already fully incorporate these adjustments, and no additional changes in accounting policies have been identified during the year.
Detailed information regarding the nature and impact of these adjustments is available in the consolidated financial statements for fiscal year 2024.
Short Seller Reports
On January 9, February 20 and March 6, 2024, a short seller firm issued reports questioning our accounting practices, corporate disclosures and commitment to transparency in an apparent attempt to drive down the market price of our shares. These reports contained numerous false and misleading statements. Nevertheless, the price of our Class A and Class B shares declined significantly. The market for our shares has been highly volatile since the publication of the reports. On January 8, 2024, the prices of our Class A and Class B shares closed at €14.24 and €10.11, respectively. On March 7, 2024, the day following the publication of the third report by the short seller, the prices of our Class A and Class B shares closed at €6.93 and €4.93, respectively.
Furthermore, following the publication of the reports, the Spanish National Securities Market Commission (Comisión Nacional del Mercado de Valores, or “CNMV”) opened an investigation in respect of the allegations made by the short seller firm and approached us with a number of inquiries, to which we have responded in a timely manner. On March 21, 2024, the CNMV issued its conclusions regarding its investigation, which confirmed that our financial statements and our indebtedness did not require a restatement. See “—CNMV Investigation’s Conclusions.” We have also voluntarily provided information to and responded to questions posed by the SEC to provide clarifications.
We undertook a number of actions to restore the confidence of markets, shareholders and other stakeholders, including: fully cooperating with the CNMV investigation and the information requests from the SEC, continuous communication with all our stakeholders and establishing a working group comprising the members of our Audit Committee, senior managers from the legal, communications, finance, investor relations and management teams, together with external advisors with expertise in communications.
In addition, on January 26, 2024 we filed a complaint in the United States District Court for the Southern District of New York against the parties responsible for the false and misleading statements in the published reports to recover the financial and reputational damages caused to us and our stakeholders as a result of such statements. The defendants moved to dismiss the complaint, and the court denied the motion in part, allowing our claims to proceed. Defendants also asserted a counterclaim under New York’s Anti-SLAPP statute, which we have vigorously opposed. As of the date of this annual report on Form 20-F, our motion to dismiss the defendants’ counterclaim remains pending before the court. We are continuing to actively prosecute our claims and are engaged in discovery.
CNMV’s Investigation Conclusions and Administrative Sanction Procedure
As a result of the publication of certain reports by a short seller that included numerous false and misleading statements, more fully described in “—Short Seller Reports” above, the CNMV opened an investigation in respect of the allegations made by the short seller firm and approached us with a number of inquiries, to which we responded in a timely manner.
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On March 21, 2024, the CNMV issued its conclusions regarding its investigation. Most importantly, the CNMV concluded that it did not identify any need to have Grifols restate its financial statements and that all analyzed related party transactions had been carried out on an arm’s length basis. The CNMV also concluded that it had found no evidence that the financial indebtedness of Grifols as reflected in its financial statements did not comport with the facts. These conclusions constituted a rejection of the claims made by the short seller firm on these points.
Specifically, the CNMV found reasonable and consistent with IFRS, Grifols’ accounting treatment of the following:
The CNMV did consider that the transaction with ImmunoTek (see Item 4 of this Part I, “Information on the Company—B. Business Overview—Raw Materials” and Note 10 to the audited consolidated financial statements included in this annual report) should have been accounted for as a joint operation pursuant to IFRS 11 instead of a financial investment. This conclusion resulted in the correction of errors in the comparative figures of prior periods in our consolidated financial statements as of and for the year ended December 31, 2024. See “—Changes in Accounting Criteria and Correction” above.
In addition, the CNMV identified the following areas for improvement in our periodic disclosures: (i) the level of detail of certain explanatory notes in our financial statements, (ii) the breakdown and level of detail of related party transactions, and (iii) the presentation of non-accounting financial performance indicators. At the request of the CNMV, on April 4, 2024, we published a note to the market providing additional information and explanations about these areas of improvement and other financial disclosures. Such note was furnished to the SEC as a current report on Form 6-K.
On September 25, 2024, the Executive Committee of the CNMV initiated an administrative sanctioning procedure against us. This procedure was based on the conclusions and areas for improvement described above. On November 7, 2024, we submitted allegations against the initiation of the administrative sanctioning procedures. On May 16, 2025, we requested that the CNMV conclude the administrative procedure, which concluded with the resolution of the CNMV on June 25, 2025, initiating a two-month period to commence the contentious-administrative procedure before the National High Court. The appeal was formally filed before the National High Court on September 24, 2025, and was admitted for processing by decree dated October 7, 2025. See Item 8 of this Part I, “Financial Information—A. Consolidated Statements and Other Financial Information—Legal Proceedings.”
On September 25, 2024, the CNMV also initiated a sanctioning proceeding against the short seller firm that issued the reports described above. In its official public announcement, the CNMV stated that it had identified well-founded indications of manipulation of information in the short sellers’ actions by including biased, false or misleading elements in its report of January 9, 2024, as well as a breach of the obligations relating to the objective presentation of investment recommendations.
Additionally, the CNMV mentioned in its public announcement that it forwarded all information regarding the possible manipulative conduct by the short seller firm to the Spanish Public Prosecutor’s Office, which found grounds for criminal actions and initiated a criminal proceeding against the short seller firm at the Spanish High National Court. Criminal proceedings relating to these matters are ongoing; the court has taken investigative steps, including summoning individuals associated with the short seller firm to appear as investigated persons.
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Price Controls
Certain healthcare products, including plasma derivative products, are subject to price controls in many of the markets where they are sold, including Spain and other countries in the European Union. The existence of price controls over these products has adversely affected in the past, and may continue to adversely affect, our ability to maintain or increase our prices and gross margins. See Item 3 of this Part I, “D. Risk Factors—Risks Relating to the Healthcare Industry—Government pressures and constraints on reimbursement may adversely affect our business” and Item 4 of this Part I, “E. Regulatory Matters—Pharmaceutical Pricing and Reimbursement.”
Plasma Supply Constraints
Plasma is the key raw material used in the production of plasma-derived products. Our ability to continue to increase our revenue depends substantially on increased access to plasma. We currently obtain our plasma mainly from the United States and Europe (Germany, Austria and Hungary) primarily through our plasma collection centers and, to a much lesser extent, through agreements with third parties.
A continued increase in demand for plasma products could lead to industry supply constraints. In response, certain of our competitors and independent suppliers could open a number of new plasma collection centers. As of December 31, 2025, we operated over 400 plasma collection centers located across the United States, Europe, across Germany, Austria and Hungary; Canada and Egypt (through our joint venture with NSPO). We have expanded our plasma collection network through a combination of organic growth, by opening new plasma collection centers, and acquisitions. For example, in 2025, we completed the acquisition of 28 plasma collection centers in the United States from ImmunoTek. In addition, we are focused on optimizing our plasma collection center network by closing or consolidating underperforming centers, having closed or consolidated seven centers in 2023, four in 2024 and four in 2025. See Item 4 of this Part I, “B. Business Overview—Raw Materials.”
Recent Acquisitions
Canadian Plasma Resources Corporation
On November 1, 2025, we acquired 50.1% of Canadian Plasma Resources Corporation, a private Canadian company dedicated to plasma collection for the production of plasma-derived therapies. The transaction was performed through the subscription of new shares for approximately €19 million, including directly attributable transaction costs. Following the acquisition, the company was renamed “Grifols Canada Plasma Corporation.” Notwithstanding our majority shareholding, existing governance arrangements and contractual obligations limit our ability to exercise control over this entity. Accordingly, our interest is accounted for under the equity method. See Note 3 to our audited consolidated financial statements included in this annual report.
Biotest shares and Public Delisting Purchase Offer
On February 14, 2025, we acquired 589,694 non-voting preferred shares of our subsidiary Biotest, representing approximately 1.5% of its share capital, at a price of €30.0 per share. We disbursed a total amount of €18 million in connection with this acquisition. In May 2025, we launched, through our subsidiary Grifols Biotest Holdings GmbH, a public delisting purchase offer to acquire all no-par bearer common shares and all non-voting bearer preferred shares of Biotest, at a price of €43.00 per common share and €30.00 per preferred share.
The acceptance period ended on June 6, 2025, the date from which Biotest’s shares ceased trading on the Frankfurt Stock Exchange, and the offer was accepted for a total of 416,922 ordinary shares, representing approximately 2.1% of the total voting ordinary shares and 1.1% of Biotest’s total share capital, and 3,002,804 non-voting preferred shares, representing approximately 15.2% of the total preferred shares and approximately 7.6% of Biotest’s total share capital. We disbursed a total amount of €108 million in connection with this offer. Subsequently, in September and October 2025, the Group carried out several acquisitions. Grifols purchased 31,627 preferred shares, representing approximately 0.2% of the total non-voting preferred shares and 0.1% of Biotest’s share capital, at a price of €30.00 per share, as well as 549 ordinary voting shares at a price of €43.00 per share. We paid a total of €1 million for these acquisitions.
As a result of the delisting offer and other acquisitions during 2025, as well as the completion of a squeeze-out procedure initiated in 2022, we directly and indirectly hold 100.0% of the total ordinary voting shares and 61.6% of the total non-voting preferred shares of Biotest, which in the aggregate represent 80.8% of Biotest’s share capital.
Acquisition of plasma collection centers from ImmunoTek
On February 3, 2025, we completed the acquisition of 28 plasma collection centers in the United States from ImmunoTek. This acquisition was completed pursuant to the collaboration agreement entered into with ImmunoTek on July 29, 2021, amended in 2023 and 2024, to arrange for the construction, licensing and commissioning of the 28 centers. Pursuant to this collaboration agreement, we formed ITK JV, a joint operation company through which we initially held a 75% interest in each of the 28 plasma collection centers, while ImmunoTek held the remaining 25%. In 2024, we acquired 14 collection centers for an aggregate amount of $266 million and, in 2025, we acquired the remaining 14 centers for an aggregate amount of approximately $281 million.
Although the acquisition of the last six plasma collection centers was scheduled for January 2026, we amended the collaboration agreement with ImmunoTek to purchase these centers as of February 3, 2025, for a total purchase price of $122 million, $60 million of which we had paid in advance, and the remaining $62 million thereof was paid on January 2, 2026 (as provided in the original agreement). Such payment deferral was documented in a promissory note issued by our subsidiary Biomat Holdings LLC in favor of ImmunoTek in an amount of $70 million, which included management fees payable to ImmunoTek of approximately $8 million and with no interest accrual. The six plasma collection centers served as collateral for the promissory note, which matured on January 2, 2026, on which date we fully settled it.
Due to the acquisition of 14 centers in 2024 and the remaining 14 centers in 2025, we now fully own and manage, through our subsidiary Biomat Holdings LLC (which owns Grifols Bio North America LLC (“GBNA”)), all 28 plasma collection centers developed by ImmunoTek under the collaboration agreement entered into in July 2021.
The collaboration with ImmunoTek has now been terminated and GBNA is no longer a member of the ITK JV. On February 3, 2025, ImmunoTek released three of the five guarantees that GBNA had granted to ImmunoTek in June 2023 for lease contracts related to certain ImmunoTek plasma collection centers not affected by the collaboration under the ITK JV. The remaining two guarantees, with an aggregate amount of approximately $20 million, will remain in force for as long as the lease agreements remain in force. The amount of the guarantees will be reduced as and when the underlying lease term is reduced. See “—Factors Affecting Our Financial Condition and Results of Operations—Recent Acquisitions,” item 4 of this Part I “Information on the Company—B. Business Overview—Raw Materials” and Notes 3(a), 10 and 34 to our audited consolidated financial statements included in this annual report.
Araclon Biotech, S.L.
On March 7 and December 16, 2025, through our subsidiary Grifols Innovation and New Technologies Limited, we acquired a total of 1.3% of the share capital of Araclon for an aggregate amount of €11 million. As a result, as of December 31, 2025, we hold 77.1% of Araclon’s share capital. See Note 17(a) to our consolidated financial statements included in this annual report.
Haema Plasma Kft.
On October 31, 2024, through our subsidiary GWWO, we acquired 100% of the capital of Haema Plasma Kft. from Scranton Plasma, B.V. for an amount of €35 million. Subsequently, in October 2025, GWWO sold Haema Plasma Kft. to another of our subsidiaries, Biotest. See Notes 2(b), 11, 17(b) and 31 to our consolidated financial statements included in this annual report. See also Item 7 of this Part I “Principal Shareholders and Related Party Transactions—B. Related Party Transactions—Haema Plasma Kft.”
Saskatoon plasma center
On July 7, 2023, through our wholly owned subsidiary Grifols Canada Plasma II, Inc. (formerly known as Prometic Plasma Resources, Inc.), we acquired a plasma donation center in Saskatoon (Canada) from Canadian Plasma Resources Corporation (now named to Grifols Canada Plasma Corporation) for approximately €8 million. See Note 3(c) to our consolidated financial statements as of and for the year ended December 31, 2024, included in this annual report.
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Recent Dispositions
Shanghai RAAS
On June 18, 2024, we closed the sale of a 20% equity stake in Chinese company Shanghai RAAS in exchange for approximately $1.8 billion, while retaining a stake in Shanghai RAAS of 6.58%, to the Haier group (“Haier”).
As part of the agreement with Haier, (1) we retained a director on the board of directors of Shanghai RAAS; (2) we and Haier shall not transfer any of our respective shares in Shanghai RAAS for a period of three years following the closing of the transaction; and (3) we committed to (a) cause our subsidiary GDS, in which Shanghai RAAS owns 45% of the economic rights and 40% of the voting rights, to achieve an aggregate earnings before interest, taxes, depreciation and amortization of $850 million for the period from 2024 to 2028, provided that any deficit in such performance would oblige us to indemnify Shanghai RAAS in an amount equivalent to a percentage of said deficit proportionate to the percentage of GDS’ capital stock held by Shanghai RAAS on such date, (b) for so long as we control GDS directly or indirectly, use our commercially reasonable efforts, without obligation, to ensure that GDS declares and distributes dividends to its shareholders in each year after closing in an amount not less than 50% of the net profits of GDS for that year, and (c) assign the voting rights relating to our remaining 6.58% of Shanghai RAAS shares to Haier for a period of ten years from the payment of the purchase price by Haier. Based on the historical performance of GDS, we believe that GDS will achieve the operational performance requirement and no indemnification will become due.
As part of the Strategic Alliance and Share Purchase Agreement, we extended the term of our existing exclusive albumin distribution agreement with Shanghai RAAS through 2034, with the possibility for an additional ten-year extension, and guaranteed minimum supply volumes thereunder through 2028. We maintained and extended our presence in China, with our sights set on further developing the Chinese plasma industry and exploring new opportunities and synergies in the diagnostic sector, while using the proceeds of the sale to significantly reduce debt. See Note 3 to our audited consolidated financial statements included in this annual report.
Subject to certain minority shareholder remedies in the charters of Biomat USA and Biomat Newco, we continue to oversee all aspects of the Biomat Group’s management and operations. All plasma collected by the Biomat Group will continue to be supplied to us for the production of plasma-derived medicines, through a long-term plasma supply agreement.
Operational Improvement Plan
In 2023, we implemented an operational improvement plan designed to reinforce our competitiveness and build a more streamlined, efficient and cost-effective global organization (the “Operational Improvement Plan”). The plan focused on three major areas: optimizing plasma costs and operations, streamlining corporate functions, and enhancing other efficiencies across the organization.
The first part of the plan, optimization of plasma costs and operations, improved our plasma procurement operations and enabled us to maintain desired plasma volumes while reducing the cost per liter of plasma through a set of measures including the closure or consolidation of 18 underperforming plasma collection centers in 2022 and seven in 2023, reduction in compensation paid to plasma donors and installation of new and more efficient plasmapheresis equipment, which increases yield.
The second part of the plan, streamlining corporate functions, caused a reduction in staff in relation to its 2023 levels of approximately 8.0% of our workforce (or approximately 2,000 employees), mainly in plasma operations in the United States, by means of initiatives such as centralizing and automating functions, consolidating vendors and eliminating duplicative functions and positions. In 2025, we had a severance expense of €8 million (€14 million in 2024 and €75 million in 2023) in relation to these initiatives.
The third part of the plan, enhancing other efficiencies across the organization, enabled us to reduce operational costs related to, among other things, global procurement, logistics, and facilities. Such reductions in operational costs required initiatives such as real estate rationalization affecting certain offices, but not industrial facilities, and establishing global organizations around commercial, industrial and supply chain functions.
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The Operational Improvement Plan has increased our operating cash flow and improved our financial performance, resulting in cost savings in our operations. In 2025 and 2024, our operating cash flows were €1.0 billion and €902 million, respectively, up from €217 million in 2023, driven in part by the sustained impact of the measures implemented under the plan. In 2023, measures under the Operational Improvement Plan resulted in a 32.0% rise in plasma collections per full-time employee, signaling improved labor productivity, and a 5.0% reduction in the manufacturing costs of our products in 2023 as compared to 2022.
In accordance with IFRS accounting rules, the effects mentioned above are of a non-recurring nature as they relate to one-off, extraordinary measures. In 2025, 2024 and 2023, we recorded a reorganization impact of €12 million, €36 million and €159 million, respectively, related to the Operational Improvement Plan. These charges related mainly to severance payments, advisory fees, and other reorganization activities.
Other Factors
Our financial and operating prospects can also be significantly affected by a number of other internal and external factors, such as unfavorable changes in governmental regulation or interpretation, increased competition, the inability to hire or retain qualified personnel necessary to sustain planned growth, the loss of key senior managers, problems in developing some of the international operations and lack of sufficient capital, among others.
Overview
The subsequent discussion and analysis provide information that our management believes is relevant to an assessment and understanding of our consolidated results of operations. You are encouraged to read the following discussion and analysis of our financial condition and results of operations together with our audited consolidated financial statements and the related notes included elsewhere in this annual report on Form 20-F.
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Year ended December 31, 2025, as compared to the year ended December 31, 2024:
Change
Consolidated Statement of Profit and Loss Data
€
Continuing Operations
Net revenue
312
Cost of sales
(4,665)
(4,418)
(247)
5.6
Gross margin
2,859
2,794
2.3
Research and development
(426)
(384)
(42)
10.9
Selling, general and administration expenses
(1,183)
(1,255)
(5.7)
Operating expenses
(1,609)
(1,639)
(1.8)
Other Income
—
Profit/(loss) of equity accounted investees with similar activity to that of the Group
(8)
(45)
(121.6)
Operating result
1,243
1,192
Finance income
(10)
(22.7)
Finance costs
(625)
(714)
(12.5)
Dividends
0
Financial costs of sale of trade receivables
(14)
(31)
(54.8)
Change in fair value of financial instruments
65.0
Impairment of financial assets
(3)
(9)
(66.7)
Exchange differences
(55)
(60)
(8.3)
Finance result
(628)
(748)
120
(16.0)
Profit/(loss) of equity accounted investees
Profit before income tax
615
444
171
38.5
Income tax expense
(115)
(231)
116
(50.2)
Consolidated net profit
500
213
287
134.7
Net revenue is calculated by subtracting certain chargebacks, cash discounts, volume rebates, Medicare and Medicaid discounts and other discounts from our gross revenue, which is mainly generated by the sale of goods. See Notes 5 and 22 to our audited consolidated financial statements included in this annual report on Form 20-F.
Our business units reported a record performance in 2025 in terms of total consolidated net revenue. Our net revenue increased by 4.3% (7.0% at constant currency), or €312 million, in 2025, reaching €7.5 billion compared to €7.2 billion in 2024. These results were mainly attributed to reduction in the cost per liter of plasma collected, strong demand for our key proteins, with the increase in total net revenue being largely due to the performance of our Biopharma business unit, as explained below.
The following table reflects a summary of net revenue by each of our business units for 2025, as compared to 2024:
% var CC(1)
8.4
(0.8)
1.4
(28.7)
(19.7)
16.8
8.6
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Biopharma. Net revenue for the Biopharma business unit increased by 5.6% (8.4% at constant currency) from €6.1 billion in 2024 to €6.5 billion in 2025. This increase was mainly supported by the strong performance of our immunoglobulin franchise, driven by robust underlying demand.
Our immunoglobulin franchise (one of our main proteins representing approximately 63.0% of the Biopharma business units’ revenue) recorded a revenue increase of 11.5% (14.7% at constant currency) in 2025 in comparison to 2024, driven by strong demand in key international markets, particularly the U.S. Subcutaneous immunoglobulin (SCIG) stood out with a revenue growth of 55.4% (59.5% at constant currency), gaining market share and increasing penetration in the United States. Intravenous immunoglobulins (IVIG) also performed well, with revenue increase of 9.1% (12.1% at constant currency) in 2025 as compared to 2024.
This performance reflects sustained demand in primary (PID) and secondary (SID) immunodeficiencies, as well as in the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). These results also reflect the expansion of the treated patient base and the progressive adoption of our subcutaneous solutions, which offer patients greater convenience and flexibility. In addition, increased product availability enabled us to meet growing demand and reinforce our leadership in key markets.
Revenues from sales of Alpha-1 and specialty proteins decreased by 0.8% (an increase of 1.4% at constant currency) in 2025 as compared to 2024. Specifically, sales of Alpha-1 antitrypsin decreased slightly in 2025 as a result of the impact in 2025 of costs associated with the Inflation Reduction Act and a reclassification of managed care fees in the United States, partially offset by the positive impact of the addition of a new distributor to strengthen commercial coverage and improve market access. Rabies immunoglobulin also showed solid commercial traction, while the rest of our specialty proteins provided positive contributions to our revenue growth.
Revenues from albumin were particularly affected by market conditions in China, where albumin prices declined as a direct result of Chinese government policies aimed at containing healthcare spending. As a result, net revenue from our albumin sales in 2025 decreased by 7.7% (5.1% at constant currency) as compared to 2024.
Diagnostic. The Diagnostic business unit decreased by 0.8% from €645 million in 2024 to €640 million in 2025, primarily due to unfavorable currency translation effects. At constant currency, revenue increased by 1.4%, reflecting strong underlying performance driven by our established market positions in the Blood Typing Solutions (BTS) and Molecular Donor Screening (MDS) businesses and a gradual shift in the sales mix toward higher value-added technologies.
Net revenue from the MDS area, associated with NAT technology for blood and plasma donation screening, increased by 0.9% (3.3% at constant currency) in 2025 as compared to 2024, driven by stable donation levels in the United States, the signing of new contracts, and expansion in South America, the Middle East and Africa. Meanwhile, net revenue from sales of our BTS line increased by 4.0% (a 6.6% increase at constant currency) in 2025 as compared to 2024, consolidating BTS’ position as the main growth driver for the Diagnostic business unit. This progress was fueled by increased demand in key markets.
Bio Supplies. Net revenue from Bio Supplies decreased by 28.7% (19.7% at constant currency), from €216 million in 2024 to €154 million in 2025, primarily due to the postponement of scheduled shipments to the Japan Blood Products Organization (JBPO) of Anti-D, Tetanus and Anti-HB products, which are now expected to occur in 2026.
Others. Net revenue from Others increased by 16.8% (8.6% at constant currency) from €208 million in 2024 to €243 million in 2025. This increase was mainly explained by higher sales performance of Healthcare Solutions and lower contract manufacturing business segment.
104
The following table reflects a summary of net revenue by each of our geographic regions for 2025 as compared to 2024:
European Union(2)(3)
7.7
4.1
7.4
Rest of the World(3)
1.9
5.3
Net revenue in the United States and Canada increased by 4.1% (7.4% at constant currency) from €4.1 billion in 2024 to €4.3 billion in 2025. This increase was mainly due to the continued underlying demand in the U.S. market. Meanwhile, net revenue in the European Union increased by 7.6% (7.7% at constant currency) from €1.5 billion in 2024 to €1.6 billion in 2025, mainly due to relevant launches of new IG franchise products in several core European countries. Net revenue in the Rest of the World increased by 1.9% (5.3% at constant currency) from €1.63 billion in 2024 to €1.66 billion in 2025, mainly due to strong underlying demand for our Biopharma and immunoglobin products, which was partially offset by a decline in albumin revenues in China due to price-control measures implemented by the Chinese government.
Cost of sales increased by 5.6% from €4.4 billion in 2024 to €4.7 billion in 2025. Cost of sales as a percentage of net revenue increased to 62.0% in 2025 compared to 61.3% in 2024. This was mainly due to price, geographic mix of sales and higher inventory provisions resulting from excess production relative to demand for certain products. See “—Operational Improvement Plan” and Item 4 of this Part I, “Information on the Company—Business Overview— Raw Materials.”
Gross Margin
Our gross margin for 2025 decreased slightly to 38.0% of our net revenue (38.7% in 2024), primarily due to the impact in 2025 of costs associated with the Inflation Reduction Act, the reclassification of certain expenses, including the transfer of co-pay and managed care expenses from operating expenses to contra-revenue and the transfer of certain operating expenses to cost of goods sold, and the effect of adverse market conditions for albumin in China resulting from the implementation of price control measures by the Chinese government. See “—Operational Improvement Plan” and Item 4 of this Part I, “Information on the Company—Business Overview—Raw Materials.”
Research and development spending increased by 10.9%, from €384 million in 2024 to €426 million in 2025, primarily driven by impairment charges of €45 million, including a €35 million write-off of an ongoing research and development project acquired from Alkahest following a change in strategic priorities and €10 million impairment associated with goodwill related to Alkahest. See Item 4 of this Part I, “Information on the Company—B. Business Overview—Research and Development” for additional details.
Selling, general and administration expenses decreased by 5.8% from €1.3 billion in 2024 to €1.2 billion in 2025. This decrease was due to lower professional fees and expense reclassification to cost of sales.
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Finance result in 2025 represented a loss of €628 million, compared to a loss of €748 million in 2024. This improvement reflects the positive impact of the refinancing measures implemented in recent years to optimize the Group’s capital structure, extend maturities and reduce the overall cost of debt. In particular, the improvement was driven by the replacement of debt maturing in 2024 and 2025 with new long-term senior secured bonds maturing in 2030, together with prepayments of term loans and the reduced utilization of our revolving credit facilities.
In 2025, we had a profit before income tax of €615 million and income tax expense of €115 million, which represents a tax rate of 18.7%. Our effective tax rate decreased from 52.1% in 2024 to 18.7% in 2025, primarily due to the €32 million in extraordinary taxes incurred in 2024 due to the Shanghai RAAS sale no longer being applicable, as well as the regularization of the tax rate in Germany contributed an impact of €51 million to this more favorable tax landscape. The company continues to maintain adequate provisions to cover Uncertain Tax Positions (UTPs) as described in the consolidated financial statements. See Note 28(a), (b) and (q) to our audited consolidated financial statements included in this annual report on Form 20-F.
Year ended December 31, 2024, as compared to the year ended December 31, 2023:
2023(1)
620
(4,109)
(309)
7.5
2,483
311
12.5
(395)
(2.8)
(1,373)
118
(8.6)
(1,768)
(7.3)
(100)
(27)
(42.2)
782
410
52.4
(18)
(29.0)
(597)
(117)
19.6
(25)
(6)
24.0
1,900.0
(16)
(44)
275.0
(575)
(173)
30.1
(100.0)
206
238
115.5
(43)
(188)
437.2
163
30.7
See “Factors Affecting Our Financial Condition and Results of Operations—Changes in accounting criteria and correction” above and see Notes 2(d) and 10 to our consolidated financial statements as of and for the year ended December 31, 2025, included in this annual report on Form 20-F.
Net revenue is calculated by subtracting certain chargebacks, cash discounts, volume rebates, Medicare and Medicaid discounts and other discounts from our gross revenue, which is mainly generated by the sale of goods. See Note 24 to our audited consolidated financial statements included in this annual report on Form 20-F.
106
Our business units reported what was then a record performance in 2024 in terms of total consolidated net revenue. Our net revenue increased by 9.4% (10.3% at constant currency), or €620 million, in 2024, reaching €7.2 billion compared to €6.6 billion in 2023. Positive market dynamics, including strong demand for our key proteins, in conjunction with the recovery of our plasma collection volumes were critical to these results, with the increase in total net revenue being largely due to the performance of our Biopharma business unit, as explained below.
The following table reflects a summary of net revenue by each of our business units for 2024, as compared to 2023:
10.5
11.3
(3.8)
2.1
34.8
35.3
2.8
3.5
Net revenue variance in constant currency is determined by comparing adjusted current period net revenue, calculated using prior period monthly average exchange rates, to the prior period net revenue. See “Presentation of Financial and Other Information—Constant Currency.”
Biopharma. Net revenue for the Biopharma business unit increased by 10.5% (11.3% at constant currency) from €5.6 billion in 2023 to €6.1 billion in 2024. This increase was mainly due to solid performance of key proteins driven by strong global underlying demand, lower cost per liter of plasma collected, strong results from sales outside the United States and Canada and a favorable volumes and product mix. In 2024, there was an increase in sales of immunoglobulins (one of our main proteins representing approximately 60% of the Biopharma business units’ revenue), the net revenue of which grew by 14.5% (15.3% at constant currency) fueled by strong demand for intravenous immunoglobulin (IVIG) and subcutaneous immunoglobulin (SCIG) Xembify, with SCIG reporting an increase of 15.3% (55.5% at constant currency).
In 2024, net revenue from our albumin sales increased by 7.1% (8.0% at constant currency) as compared to 2023, continuing to see increased demand across China and the U.S. Net revenue from sales of Alpha-1 and specialty proteins increased by 4.1% (4.9% at constant currency) in 2024 as compared to 2023. The U.S. Alpha-1 franchise continues recovering momentum following the transition of the specialty pharma distributor in early 2024, while demand for rabies immunoglobulin continued to be solid.
Diagnostic. The Diagnostic business unit decreased by 3.8% (a 2.1% decrease at constant currency) from €670 million in 2023 to €645 million in 2024. The performance of this business unit was driven primarily by our established strong market position in the Blood Typing Solutions (BTS) and Molecular Donor Screening (MDS) businesses. This growth was supported by broad geographic demand across all relevant markets and increased blood and plasma donations.
Net revenue from sales of our BTS increased by 11.5% (a 14.2% increase at constant currency) while the MDS business net revenue decreased by 5.3% (a 3.9% decrease at constant currency). These results were driven by our broad geographic demand across all relevant markets and increased blood and plasma donations.
Bio Supplies. Net revenue from Bio Supplies increased by 34.8% (35.3% at constant currency), from €160 million in 2023 to €216 million in 2024, mainly due to strong sales of bio supplies commercial products to third-party biopharma companies and the integration of access biologicals, expanding market reach and customer base.
Others. Net revenue from Others increased by 2.8% (3.5% at constant currency) from €204 million in 2023 to €208 million in 2024. This increase was due to the expansion of our Healthcare Solutions business line, driven by the demand of hospital solutions for parenteral nutrition and compounding pharmacy services.
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The following table reflects a summary of net revenue by each of our geographic regions for 2024 as compared to 2023:
% of total net
revenue
European Union(2)
19.3
22.7
4.8
Rest of the World
13.2
Net revenue in the United States and Canada increased by 4.8% (5.6% at constant currency) from €3.9 billion in 2023 to €4.1 billion in 2024. This 4.8% increase was mainly due to the continued underlying demand in the U.S. market. Meanwhile, net revenue in the European Union increased by 19.3% (19.4% at constant currency) from €1.3 billion in 2023 to €1.5 billion in 2024, mainly due to relevant launches of new IG franchise products in several core European countries. Net revenue in the Rest of the World increased by 13.2% (15.1% at constant currency) from €1.4 billion in 2023 to €1.6 billion in 2024, mainly due to volume growth and geographic diversification globally.
Cost of sales increased by 7.5% from €4.1 billion in 2023 to €4.4 billion in 2024. Cost of sales as a percentage of net revenue decreased to 61.3% in 2024 compared to 62.3% in 2023. This was mainly due to the continued decline in cost per liter of plasma collected (decrease of 4.4% in 2024 as compared to 2023), yield improvements and collection efficiencies throughout our plasma center network. See “—Factors Affecting our Financial Condition and Results of Operations—Operational Improvement Plan” and Item 4 of this Part I, “Information on the Company—Business Overview— Raw Materials.”
The increase in gross margin from 37.7% of net revenue in 2023 to 38.7% in 2024 was mainly due to strong revenue growth and lower cost per liter of plasma as a result of continued improvements in yields and plasma center operations. See “—Operational Improvement Plan” and Item 4 of this Part I, “Information on the Company—Business Overview—Raw Materials.”
Research and development spending decreased by 2.8%, from €395 million in 2023 to €384 million in 2024. This slight reduction in spending was due to a more efficient and disciplined approach to our research and development projects and pipeline, signaling a shift toward fewer, higher-priority, and strategic projects. See Item 4 of this Part I, “Information on the Company—B. Business Overview—Research and Development” for additional details.
Selling, general and administration expenses decreased by 8.6% from €1.4 billion in 2023 to €1.3 billion in 2024. This decrease was due to a 77.4% reduction, from €159 million in 2023 to €36 million in 2024, in the non-recurring reorganization costs composed mainly of severance payments and consultant fees associated with our Operational Improvement Plan.
Finance result in 2024 represented a loss of €748 million in 2024, compared to a loss of €574 million in 2023. The increase mainly results from higher interest expenses on new senior secured bonds issued in 2024 (7.5% for the April 2024 Notes and 7.125% for the December 2024 Notes) compared to the bonds redeemed in 2024 (3.2% for the 2017 Notes and 1.625% for series of 2019 Notes). In addition, finance costs from other financial liabilities included expenses related to the Biomat Transactions, pursuant to which the GIC Investor redeemed another class B share of Biomat Newco, and capitalized interest rates increased to a range of 6.88%–7.38% compared to 6.03%–6.79% in the prior year.
108
In 2024, we had a profit before income tax of €444 million and income tax expense of €231 million, which represents a tax rate of 52.1%. Our effective tax rate increased from 19.3% in 2023 to 52.1% in 2024, primarily due to extraordinary taxes incurred in relation to the Shanghai RAAS transaction for an amount of €32 million and to an increase in the uncertain tax provision in Spain, from €77 million in 2023 to €137 million in 2024, resulting from assessments by the Spanish tax authority in respect of differing interpretations of transfer pricing.
Regulation
For detailed information regarding the regulations applicable to our business, see Item 4 of this Part I, “Information on the Company—E. Regulatory Matters.”
Inflation and Foreign Currency Fluctuations
We historically have not been affected materially by inflation in our core geographies. However, due to the current macroeconomic context, we are having some inflation pressures on labor costs and selling, general & administrative costs. See “—Operating Results—Overview” for additional details.
For detailed information on how foreign currency fluctuations affect our business, see “—B. Liquidity and Capital Resources.” See also Item 3 of this Part I, “Key Information—Risks Relating to the Company and Our Business—Our results of operations and financial condition may be affected by adverse changes in foreign currency exchange rates, especially a significant shift in the value of the euro as compared to the U.S. dollar” and Item 11 of this Part I, “Quantitative and Qualitative Disclosures About Market Risk—Currency Risk.”
Our principal liquidity and capital requirements consist of costs and expenses relating to:
Historically, we have financed our liquidity and capital requirements through internally generated cash flows and debt financings. As of December 31, 2025, our cash and cash equivalents totaled €825 million. In addition, as of December 31, 2025, we had a liquidity position of €1.7 billion, including €853 million in unused credit facilities available under our debt agreements that included €798 million available as Revolving Loans under our First Lien Credit Facilities.
In 2025, our cash generation was driven by a solid improvement in operating cash flow, supported by profit growth and active working capital management. The year’s performance reflects the consolidation of operational improvements implemented in previous periods and sustained discipline in capital allocation. We expect our cash flows from operations combined with our cash balances and availability under the revolving loans from the New Credit Facilities to provide sufficient liquidity to fund our current obligations (primarily debt service and acquisition payments as described above), projected working capital requirements and capital expenditures for at least the next twelve months. Currently, we do not generate significant cash in any country that might have restrictions for funds repatriation, and we estimate that the existing cash located in Ireland, Spain and the United States, along with the cash generated from operations, will be sufficient to meet future cash needs in key countries.
Our capital expenditures consist primarily of expanding and enhancing our production facilities, replacing fully depreciated items and promoting efficiency of our operations. In addition, we allocate cumulative industrial capital investments to expand the manufacturing capacities of the Biopharma business unit, as well as investments in the Diagnostic and Bio Supplies business units, with the goal of improving the structure of our plasma collection centers in the United States and expanding our manufacturing facilities. We are also expanding and relocating plasma donation centers and improving infrastructures related to raw materials classification, preparation and storage facilities, logistics centers and analysis laboratories. In 2025, we maintained disciplined management of our capital investments following the intense investment cycle of recent years, prioritizing efficiency and the consolidation of existing production capacity. See “—Capital Expenditures” below.
We remain committed to deleveraging in the medium term and maintaining elevated and adequate levels of liquidity through (i) internally generated cash flows, and (ii) a substantial decrease in dividend payments in the medium term. In furtherance of this commitment, in the past few years we have continually strengthened our financial structure and market confidence through active and disciplined debt management. This proactive debt management enabled us to extend maturities, strengthen liquidity, and shape a debt profile with no significant maturities before 2027.
Among other measures, in 2024 we sold a 20% equity stake in Shanghai RAAS in exchange for approximately $1.8 billion, and used the proceeds of the sale to fully redeem the 2017 Notes. See “—A. Operating Results—Factors Affecting Our Financial Condition and Results of Operations—Recent Dispositions—Shanghai RAAS.” In addition, in November 2025, we conducted a consent solicitation process whereby we obtained the support of approximately 95% of holders of our April 2024 Notes to approve an amendment to the indenture for such notes which enhances our financial flexibility and facilitates more efficient management of our capital structure, in line with our refinancing plans communicated to the market. See “—A. Operating Results—Subsequent Events—Refinancing Plans” above and “—Sources of Credit—The April 2024 Notes” below.
Our principal existing contractual obligations as of December 31, 2025 are comprised of financial debt obligations, with principal and interest amortization for short- and long-term debt including, among other things, capitalized lease obligations and bilateral credit facilities bearing interest at market rate (see “—Sources of Credit” below and Notes 23 and 30 to our audited consolidated financial statements included in this annual report on Form 20-F for further discussion regarding our debt obligations and related interest rate agreements outstanding at December 31, 2025). We have contractual obligations involving future payments for licenses and royalties based generally on volume of sales.
Historical Cash Flows
The table below presents our net cash from operating, investing and financing activities for each of the years ended December 31, 2025, 2024 and 2023.
Net cash from (used in) operating activities
1,047
902
217
Net cash (used in) investing activities
(579)
886
(394)
Net cash from/(used in) financing activities
(529)
(1,359)
172
110
Net Cash from Operating Activities
In the year ended December 31, 2025, our net cash inflow from operating activities was €1.0 billion, due largely to robust operating results supported by the solid performance of our business units and combined with efficient working capital management. Working capital represented a cash outflow of €35 million. The principal effects on working capital were as follows:
In the year ended December 31, 2024, our net cash inflow from operating activities was €902 million, due largely to stronger operating income, improved working capital management, particularly in inventory and trade receivables, and disciplined approach to operational expenses. See “—A. Operating Results—Factors Affecting Our Financial Condition and Results of Operations—Operational Improvement Plan” and Item 4 of this Part I, “B. Business Overview—Raw Materials.” Working capital represented a loss of €13 million. The principal effects on working capital were as follows:
In the year ended December 31, 2023, our net cash from operating activities was €217 million, due largely to improved operational performance, a reduction in cost per liter of plasma collected and a reduced cost base throughout our business fueled by our Operational Improvement Plan. See “—A. Operating Results—Factors Affecting Our Financial Condition and Results of Operations—Operational Improvement Plan” and Item 4 of this Part I, “B. Business Overview—Raw Materials.” Working capital represented a loss of €376 million. The principal effects on working capital were as follows:
111
Net Cash from/(Used) in Investing Activities
Net cash used in investing activities amounted to an outflow of €579 million in 2025, compared to a net cash inflow of €886 million in 2024, a year that included the extraordinary impact of the Shanghai RAAS divestment.
In 2025, we completed the acquisition of 14 plasma collection centers from ImmunoTek for an aggregate net amount, after discounting advance payments, of $141 million, of which $62 million was deferred until January 2, 2026. Except for this transaction, our main cash outflows corresponded to recurring capital expenditure investments, as well as investments in R&D and intangible assets. These included investments related to the plasma fractionation, immunoglobulin purification, and albumin production facilities in Montreal, Canada, as well as the development of the Egypt hub.
The change in 2024 was primarily due to the sale of a 20% equity stake in Shanghai RAAS, which significantly outweighed capital expenditures and other investing outflow, as well as overall lower spending on acquisitions and investments (See “—Factors Affecting Our Financial Condition and Results of Operations—Recent Dispositions—Shanghai RAAS”). Investments made in 2024 focused primarily on the acquisition of 14 plasma collection centers from ImmunoTek, for an aggregate amount of $266 million, and the acquisition of 100% of the shares of Haema Plasma Kft., for an amount of €35 million. See “—Factors Affecting Our Financial Condition and Results of Operations—Recent Acquisitions.”
Investments made in 2023 focused primarily on capital expenditures, particularly on the Biopharma business unit’s new production facilities, including investments in plasma fractionation, immunoglobulin purification and albumin plants in Montreal (Canada), a new sterile albumin purification dosing and filling plant in Dublin, and various IT and digitalization-related projects. See”—Capital Expenditures.”
Net Cash from/(Used in) Financing Activities
Net cash used in financing activities was €529 million in 2025, primarily due to the delisting of our German subsidiary Biotest, following an increase in our ownership stake to 80.8% of the share capital and 99.25% of the voting rights together with the redemption by the GIC Investor of one preferred share of Biomat Newco for €46 million, the repayment of €32 million of the EIB Term Loans and the payment of dividends in the total aggregate amount of €128 million. See “—Liquidity and Capital Resources—Sources of Credit—The Biomat Transactions” and Item 8 of this Part I, “A. Consolidated Statements and Other Financial Information—Dividend Payments.”
Net cash used in financing activities was €1.4 billion in 2024, primarily as a result of net debt repayments related to the redemptions of the €1.0 billion senior notes issued in 2017 and the series of the 2019 Notes that would have matured in February 2025.
Net cash inflow from financing activities was €172 million in 2023, primarily due to a drawdown of €360 million from our Revolving Credit Facility (see Note 19 to our audited consolidated financial statements included in this annual report on Form 20-F), partially offset primarily by lease payments of €106 million (see Note 8(b) to our audited consolidated financial statements included in this annual report on Form 20-F), the redemption by the GIC Investor of one preferred share of Biomat Newco for €48 million and the repayment of €32 million of the EIB Term Loans.
Working Capital
Our working capital, which is driven primarily by our trade receivables turnover and inventory aging, can vary significantly from period to period depending on the activity. Our capital requirements will depend on many factors, including our rate of sales growth, acceptance of our products, continued access to adequate manufacturing capacities, maintaining cGMP compliant facilities, the timing and extent of research and development activities, and changes in operating expenses, including costs of production and sourcing of plasma, all of which are subject to uncertainty.
112
In 2025, we achieved notable improvements in working capital efficiency through enhanced inventory management, disciplined oversight of accounts payable and receivable, improved financial results and active optimization of operational cash flows, resulting in a reduction in net working capital consumption in relation to prior years. We expect that our liquidity position for the remainder of 2026 will be higher than our liquidity as of December 31, 2025, primarily due to the New Credit Facilities (entered into on April 14, 2026), which increased our access to revolving loans pursuant to a revolving credit facility of approximately $2.0 billion (as compared to the $938 million we had available pursuant to the Revolving Loans under our First Lien Credit Facilities). See Item 5 of this Part I, “Operating and Financial Review and Prospects—B. Liquidity and Capital Resources—Sources of Credit—New Credit Facilities.”
Inventory Aging
Inventory aging average decreased to 258 days at December 31, 2025, compared to 294 days at December 31, 2024, primarily reflecting an optimization of inventory levels in the context of growing activity. Inventory aging average in the Biopharma division decreased from 301 days in 2024 to 262 days in 2025 while inventory levels remained stable, as a result of a significant increase in sales.
Inventory aging average decreased from 2023 to 2024, primarily as a result of more efficient inventory management, improvements in plasma collections and the positive results of the implementation of an individualized nomogram technology in approximately 60% of the plasma collection centers in the United States, enabling more precise control over volumes collected and resulting in reduced waste of raw material and refinements in the processes for plasma fractionation, leading to a higher amount of products extracted from each liter of plasma collected. Inventory aging decreased to 294 days at December 31, 2024, compared to 308 days at December 31, 2023.
See Item 4 of this Part I, “Information on the Company—B. Business Overview—Raw Materials” for additional details.
Trade Receivables
We routinely sell receivables with maturity dates no shorter than 30 days (“Eligible Receivables”) to financial institutions (factors) in varied contractual arrangements with or without recourse. In sales of Eligible Receivables without recourse, all material risks and benefits inherent to the ownership of the assigned receivables, including the right to unilaterally transfer the assigned receivables to unrelated third parties, are transferred to the factor. These sales are considered as factoring without recourse and therefore the consideration paid to us by factors for such assigned receivables is not accounted as debt in our balance sheet.
In the fiscal years ended December 31, 2025, 2024 and 2023, we sold without recourse €1.6 billion, €3.6 billion and €2.9 billion, respectively, of receivables to third parties. We estimate the volume of net invoices we sold without recourse to financial institutions which, based on their due date, would not have been collected at December 31, 2025, to be €325 million (€312 million and €392 million at December 31, 2024 and 2023, respectively).
We also sell Eligible Receivables to financial institutions while retaining the risks and benefits inherent to the ownership thereof. These sales are considered as factoring with recourse and the amount of such assigned receivables remains on our balance sheet, while the amount advanced to us by the factors is recognized on our balance sheet as short-term debt. At December 31, 2025, similar to December 31, 2024, we had no amount recorded in our balance sheet as short-term debt in respect of factoring transactions with recourse, as compared to €17 million at December 31, 2023.
For the fiscal year ended December 31, 2025, the finance cost we recorded in our statement of profit and loss in respect of receivables sold totaled €14 million (€31 million and €25 million in the fiscal years ended December 31, 2024 and 2023, respectively). Our receivables had an aging average of 31 days at December 31, 2025, 35 days at December 31, 2024 and 36 days at December 31, 2023. See Notes 13 and 25 to our consolidated audited financial statements included in this annual report.
113
Capital Expenditures, Other Intangible Assets and Rights of Use
In 2025, we maintained disciplined management of our capital investments following the intense investment cycle of recent years. We continued optimizing our capital expenditure resource allocation, prioritizing efficiency and the consolidation of existing production capacity. In 2025, our capital expenditures totaled €265 million (€233 million in 2024). The following table presents our capital expenditures, other intangible assets and rights of use additions in the years ended December 31, 2025, 2024 and 2023, by business unit.
451
373
359
Unallocated
588
478
450
January 2023 through December 2025
Facilities. The most important capital projects relating to the expansion and improvement of our manufacturing facilities during 2025, 2024 and 2023 were:
Parets site (Barcelona, Spain):
Clayton site (North Carolina, United States):
114
Los Angeles (California, United States):
Dublin (Ireland):
Quebec (Canada):
San Diego (California, United States):
Other Investments. Other relevant capital projects relating to the expansion and improvement of our manufacturing facilities during 2025, 2024 and 2023 were:
115
January 2025 through December 2026
In 2024, we completed a €1.9 billion investment plan initiated in 2018 that involved, among other investments, cumulative industrial capital investments to expand the manufacturing capacities of the Biopharma business unit, as well as investments in the Diagnostic business unit. In 2025, we maintained disciplined management of our capital investments following the intense investment cycle. We will continue focusing on optimizing our capital expenditure resource allocation, prioritizing efficiency and the consolidation of existing production capacity.
The majority of our capital investments benefit our Biopharma business unit, systemically enhancing our manufacturing facilities. We aim to optimize utilization of our fractionation capacity by obtaining FDA and EMA licenses and completing other requirements to purify any of our intermediate products at any of our plants. We are also relocating and renovating plasma donation centers and improving infrastructures related to raw materials classification, preparation and storage facilities, logistics centers and analysis laboratories.
The main capital expenditure projects advanced in 2025 and planned for 2026 and onwards relating to the improvement of our manufacturing facilities are:
In addition, Grifols Egypt, our joint venture with NSPO, is building a new industrial facility phased as follows:
Grifols Egypt’s project is one of our most significant strategic initiatives in international expansion and health-sovereignty development. Through Grifols Egypt, the Egypt hub achieved self-sufficiency in immunoglobulins, albumin, and coagulation factors in 2025, becoming the sixth country in the world to reach this level of autonomy in plasma-derived medicines.
Grifols Egypt currently has 16 plasma-donation centers in Egypt (with 13 already operating), with plans to expand to 20 in 2026, and has a state-of-the-art testing laboratory and an integrated logistics center. It is also progressing on the first development phase of its manufacturing plant, which will begin operations in 2026. In 2025, the European Medicines Agency (EMA) certified Grifols Egypt’s entire value chain, validating the integrated end-to-end model. Since the project’s inception, more than one million vials produced from Egyptian plasma have been delivered to public hospitals and health centers, and over 100,000 free medical check-ups have been provided to donors. From a corporate perspective, the Egypt project represents a replicable public-private partnership model that integrates health sovereignty, industrial development, and international projection.
Sources of Credit
New Credit Facilities
On April 14, 2026, we entered into a Credit Agreement (the “New Credit Facilities”) with a syndicate led by Bank of America Europe Designated Activity Company, Bank of America, N.A., J.P. Morgan Securities PLC, Banco Santander, S.A., DNB Bank ASA, Sweden Branch, Citibank, N.A., London Branch, Commerzbank Aktiengesellschaft, Deutsche Bank Aktiengesellschaft, Goldman Sachs Bank Europe SE, HSBC Continental Europe, Landesbank Hessen-Thüringen Girozentrale, UBS AG London Branch, ING Bank N.V., Sucursal en España and Nomura Securities International, Inc. as the lead arrangers (the “Lead Arrangers”), which consist of the “Term Loans” and the “Revolving Loans.” Bank of America, N.A. serves as Administrative Agent. The initial Term Loans (consisting of a Dollar Tranche B Term Loan and a Euro Tranche B Term Loan) were fully drawn down on April 14, 2026. Both the Dollar Tranche B Term Loan (in original principal amount equal to $2,000,000,000) and the Euro Tranche B Term Loan (in original principal amount equal to €1,250,000,000) mature on April 14, 2033 (seven years from April 14, 2026). The Dollar Tranche B Term Loan has a repayment schedule with quarterly amortization payments on the last business day of each March, June, September and December, starting with the first full fiscal quarter ending after April 14, 2026, equal to 0.25% of the aggregate principal amount of the initial Dollar Tranche B Term Loan, with the remainder payable at maturity. The Euro Tranche B Term Loan is not subject to scheduled amortization prior to the applicable maturity date.
The Revolving Loans provide for aggregate commitments of $2,065,000,000, and are available during the period commencing from April 14, 2026, and ending on (i) October 14, 2032 or (ii) if a springing maturity condition applies, the date that is 91 days prior to the maturity date of the earliest maturing Material Indebtedness (as defined in the New Credit Facilities) that has not been extended, replaced, refinanced or repaid with indebtedness maturing no earlier than 91 days after October 14, 2032.
We are using the proceeds from the initial Term Loans (i) to repay in full and terminate the First Lien Credit Facilities, (ii) to redeem and discharge the remaining outstanding amount of the 2019 Notes, (iii) to pay related fees, premiums and expenses and (iv) for general corporate purposes.
The borrowers under the New Credit Facilities are Grifols International Services USA Inc., a Delaware corporation and wholly owned indirect subsidiary of Grifols (the “U.S. Borrower”) and Grifols International Services Designated Activity Company, a designated activity company validly incorporated and existing under the laws of Ireland and a wholly owned direct subsidiary of Grifols (the “Irish Borrower” and together with the U.S. Borrower, each a “Borrower” and collectively, the “Borrowers”). The borrower under the Euro-denominated Tranche B facility is the Irish Borrower, and the borrower under the Dollar-denominated Tranche B facility is the U.S. Borrower. Both Borrowers are borrowers under the revolving credit facility. The New Credit Facilities are governed by New York law; however, certain collateral documents are governed under the local law of other jurisdictions.
The interest rates on the Revolving Loans are (a) until delivery of the financial statements for the first full fiscal quarter ending after April 14, 2026, the Adjusted Term SOFR Rate (if denominated in Dollars), the EURIBOR Rate (if denominated in Euros), the SONIA Rate (if denominated in Sterling) or the Adjusted Term CORRA Rate (if denominated in Canadian Dollars), plus 2.00%, and (b) thereafter, subject to a pricing grid based on consolidated total net leverage ratio, with applicable margins for benchmark rate loans (Term SOFR Rate, EURIBOR Rate, SONIA Rate or Term CORRA Rate) ranging from 1.25% to 2.00% and margins for base rate loans ranging from 0.25% to 1.00%.
The interest rates on the Dollar Tranche B Term Loan are, (a) until delivery of the financial statements for the first full fiscal quarter ending after April 14, 2026, either (i) the Adjusted Term SOFR Rate plus 2.50% or (ii) the base rate plus 1.50%, and (b) thereafter, the applicable margin is subject to a pricing grid based on consolidated total net leverage ratio with applicable margins for Term SOFR Rate Loans ranging from 2.25% to 2.50% and for base rate loans ranging from 1.25% to 1.50%.
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The interest rate on the Euro Tranche B Term Loan is (a) until delivery of the financial statements for the first full fiscal quarter ending after April 14, 2026, EURIBOR Rate plus 3.00%, and (b) thereafter, the applicable margin is subject to a pricing grid based on consolidated total net leverage ratio with applicable margins ranging from 2.50% to 3.00%.
Borrowings under the New Credit Facilities are subject to mandatory prepayment upon the occurrence of certain events, including the incurrence of certain debt and the sale or other disposition of certain assets. In addition, a portion of the borrowings under the New Credit Facilities are subject to mandatory prepayment in the event we have excess cash flow, as defined therein. Both the Term Loans and the Revolving Loans are guaranteed by Grifols (solely in respect of the obligations of the Borrowers) and certain subsidiaries of Grifols that together with Grifols represented, as of December 31, 2025, in aggregate, at least 60.0% of the earnings before interest, tax, depreciation and amortization of Grifols and its subsidiaries (calculated in accordance with the formula set forth in the New Credit Facilities, the “Guarantor Coverage Test”), and are secured by a perfected first priority security interest (subject to permitted liens, as described in the First Lien Credit Facilities) in substantially all of the tangible and intangible assets of the U.S. credit parties and plasma inventory of GWWO and pledges of equity of certain subsidiaries of Grifols (subject to certain exclusions and limitations). As of the date of this Annual Report on Form 20-F, the New Credit Facilities are guaranteed by our subsidiaries GWWO, Grifols Worldwide Operations USA, Grifols Biologicals LLC, Grifols Shared Services North America, Inc., Grifols Therapeutics LLC, Instituto Grifols, S.A., Grifols International, S.A., Grifols USA, LLC, and Grifols Biotest Holdings GmbH and the Borrowers.
The New Credit Facilities include customary affirmative and negative covenants and events of default. Negative covenants include, among other limitations, limitations on additional debt, liens, asset sales and affiliate transactions. The New Credit Facilities also contain a financial maintenance covenant requiring that the consolidated total net leverage ratio not exceed 7.00:1.00, tested at the end of each fiscal quarter, commencing with the first full fiscal quarter after April 14, 2026. Events of default include, among other events, violation of covenants, material breaches of representations, cross default to other material debt, bankruptcy and insolvency, material judgments and change of control.
The terms of the New Credit Facilities contain limitations on our ability to make restricted payments, including paying ordinary dividends, including (a) for so long as no Event of Default has occurred and is continuing or would result therefrom, in an amount per annum not to exceed (A) if the Consolidated Total Net Leverage Ratio (as defined in the New Credit Facilities) does not exceed 4.00:1.00, 6.00% of Market Capitalization (as defined in the New Credit Facilities), or (B) if the Consolidated Total Net Leverage Ratio is greater than 4.00:1.00, 4.00% of Market Capitalization, which dividends may be paid in installments during the applicable fiscal year and the subsequent fiscal year in a manner consistent with past practice, or (b) for so long as no Event of Default has occurred and is continuing or would result therefrom and the Consolidated Total Net Leverage Ratio on a pro forma basis would be less than or equal to 3.75:1.00. We may make regularly scheduled payments of interest in respect of the 2021 Notes to the extent required by the terms of the documentation governing such notes.
European Investment Bank Term Loans
On October 28, 2015, GWWO entered into a loan agreement with the European Investment Bank for a term loan of €100 million under the European Fund for Strategic Investments (the “2015 EIB Term Loan”), which was amended on December 5, 2017, April 15, 2019, and on November 15, 2019. The financial terms of the loan agreement included a fixed interest rate of 2.40% for a tenor of 10 years from October 28, 2015, and a repayment schedule with amortization in years three through ten. The proceeds of this loan were used to support our research and development, primarily focusing on the search for new indications for plasmatic proteins, including the treatment of Alzheimer’s disease, vascular disease, cardiovascular surgery and arterial thrombosis, amongst others. The 2015 EIB Term Loan was repaid in full at maturity (October 2025).
On December 5, 2017, we obtained a new long-term loan with the European Investment Bank totaling €85 million (the “2017 EIB Term Loan”), which was amended on April 15, 2019 and on November 15, 2019. The financial terms of the loan included a fixed interest rate of 2.019% for a tenor of ten years and a two-year grace period before any payment of principal becomes due and payable. The proceeds of this loan were used for research and development initiatives, notably the discovery and development of new products (plasma proteins), the finding of new therapeutic indications for existing plasma proteins and the improvement of manufacturing processes to increase yields, safety and efficiency.
On September 7, 2018, we obtained a new long-term loan with the European Investment Bank totaling €85 million (the “2018 EIB Term Loan” and, together with the 2015 EIB Term Loan and the 2017 EIB Term Loan, the “EIB Term Loans”), which was amended on April 15, 2019 and on November 15, 2019. The financial terms of the loan agreement included a fixed interest rate of 2.145% for a tenor of 10 years and a two-year grace period before any payment of principal becomes due and payable. The proceeds of this loan were used for research and development initiatives, notably the discovery of new therapeutic indications for plasma-derived protein therapies.
The EIB Term Loans were guaranteed by the same entities that guaranteed the First Lien Credit Facilities described below and were secured by a perfected first priority security interest (subject to permitted liens, as defined in the documentation governing the EIB Term Loans) on the same collateral securing the First Lien Credit Facilities, the 2019 Notes, the April 2024 Notes and the December 2024 Notes, each as described below (noting that the blood plasma inventory of GWWO located in Spain was not charged to secure the 2019 Notes, the April 2024 Notes or the December 2024 Notes), subject to a customary pari passu intercreditor agreement entered into by and among Grifols, GWWO, certain subsidiaries of Grifols party thereto, the European Investment Bank, Bank of America, N.A., as collateral agent under the First Lien Credit Facilities, and The Bank of New York Mellon, London branch, as collateral agent under the 2019 Notes, the April 2024 Notes and the December 2024 Notes.
We entered into an amendment to the EIB Term Loans on August 6, 2021 to permit (i) the consummation of the Biomat Transactions; and (ii) upon the consummation of the Biomat Transactions, the release of Biomat USA and Talecris from their respective guarantees provided under the corresponding guarantee agreement for the EIB Term Loans and that release the liens granted over the assets of Biomat USA and Talecris. The Biomat Transactions were consummated on December 1, 2021.
On September 28, 2022, we entered into Amended and Restated Accession Agreements in connection with the EIB Term Loans to add Biotest Holdings as guarantor thereunder.
As of December 31, 2025, we had €53 million in aggregate principal amount outstanding of EIB Term Loans. See Notes 23 and 30 to our consolidated audited financial statements included in this annual report. On March 16, 2026, we prepaid in full the outstanding amounts owed under the 2017 EIB Term Loan and the 2018 EIB Term Loan, resulting in the termination of the EIB Term Loans. We are currently negotiating with the EIB the execution of the corresponding documentation for the cancellation of the security interest and guarantees granted in favor of the EIB to secure/guarantee the EIB Term Loans.
First Lien Credit Facilities
On November 15, 2019, we entered into a Credit and Guaranty Agreement (the “First Lien Credit Facilities”) with a syndicate led by Bank of America Europe Designated Activity Company (formerly known as Bank of America Merrill Lynch International Limited Designated Activity Company), Bank of America, N.A., BNP Paribas S.A., Sucursal en España, HSBC France, Banco Bilbao Vizcaya Argentaria S.A., and JP Morgan Securities PLC, as the arrangers, which consist of the “Term Loans” and the “Revolving Loans.” The initial Term Loans (consisting of a Dollar Tranche B Term Loan and a Euro Tranche B Term Loan) were fully drawn down on November 15, 2019. Both the Dollar Tranche B Term Loan (in original principal amount equal to $2,500,000,000) and the Euro Tranche B Term Loan (in original principal amount equal to €1,360,000,000) would have matured in eight years from November 15, 2019 and had a repayment schedule with quarterly amortization starting on the last business day of the fiscal quarter ending on March 31, 2020, equal to 0.25% of the aggregate principal amount of the initial Dollar Tranche B Term Loan (or Euro Tranche B Term Loan, as the case may be) outstanding on November 15, 2019, with the remainder payable at maturity.
The Revolving Loans, which initially provided for a commitment of $500 million, were available during the period commencing from November 15, 2019 and ending on November 15, 2025. On May 7, 2020, we upsized the Revolving Loans, increasing the lender commitments thereunder from $500 million to $1.0 billion, with the existing and new revolving lenders. The terms and conditions of the upsized facility are similar to those entered into on November 15, 2019. As part of the upsize, the applicable margin for Revolving Loans was increased from 0.50% to 1.50% in the case of Base Rate Loans and from 1.50% to 2.50% in the case of Eurocurrency Rate Loans. Additionally, the commitment fee payable in respect of the unused Revolving Commitments was increased from 0.50% to 0.875%.
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On December 11, 2024, we executed a new upsize to the Revolving Loans whereby we (i) extended the Revolving Commitments of $585 million by 18 months, until May 2027 (the remaining $415 million still matured, and were automatically cancelled, in November 2025) (the “RCF Extension to 2027”); and (ii) increased the Revolving Commitments by an additional $278 million with the existing and new revolving lenders (increasing the total amount of Revolving Commitments under the First Lien Credit Facilities to $1.3 billion). As part of the upsize, as of December 20, 2024 the applicable margin for Revolving Loans granted by the Lenders who agreed to the RCF Extension to 2027 increased from 1.50% to 2.00% per annum, in the case of Base Rate Loans, and from, 2.50% to 3.00% per annum, in the case of Eurocurrency Rate Loans and from 2.50% to 3.00% per annum, in the case of Term SOFR Loans.
On February 21, 2025, we executed a new upsize to the Revolving Loans whereby existing and new revolving lenders agreed to further increase their commitments under the Revolving Commitments by $74 million, resulting in a total revolving commitment facility of $1.3 billion, of which $415 million matured in November 2025, with the current effective amount of Revolving Commitments being $938 million and maturing in May 2027). The purpose of each of the upsizes was to reinforce our liquidity position.
The borrower under the revolving facility was GWWO, an Irish entity and our wholly owned direct subsidiary. The borrower under the Euro denominated tranche B facility was Grifols. The borrower under the Dollar-denominated tranche B facility was Grifols Worldwide Operations USA, Inc. (“Grifols Worldwide Operations USA”), a Delaware corporation and a direct wholly owned subsidiary of GWWO. The First Lien Credit Facilities were governed by New York law; however, certain collateral documents were governed under the local law of other jurisdictions.
The interest rates on the Revolving Loans were either (a) the base rate (i.e., the greatest among (i) the prime rate, (ii) the federal funds rate plus 0.50% and (iii) the Term Secured Overnight Funding Rate (“Term SOFR”), with a one-month interest period, plus 1.00%) plus 1.50% or (b) Term SOFR (if denominated in dollars) or EURIBOR (if denominated in Euros) plus 2.50%. The interest rate on the Dollar Tranche B Term Loan was either (a) the base rate plus 1.00% or (b) Term SOFR plus 2.00%. The interest rate on the Euro Tranche B Term Loan was EURIBOR plus 2.25%.
Both the Term Loans and the Revolving Loans were guaranteed by Grifols (solely in respect of the obligations of Grifols Worldwide Operations USA and GWWO) and certain subsidiaries of Grifols that together with Grifols represented, as of December 31, 2025, in aggregate, at least 60.0% of the earnings before interest, tax, depreciation and amortization of Grifols and its subsidiaries (calculated in accordance with the formula set forth in the First Lien Credit Facilities, the “Guarantor Coverage Test”), and were secured by a perfected first priority security interest (subject to permitted liens, as described in the First Lien Credit Facilities) in all of the tangible and intangible assets of the U.S. credit parties and plasma inventory of GWWO and pledges of equity of certain subsidiaries of Grifols (subject to certain exclusions and limitations).
The First Lien Credit Facilities included customary affirmative and negative covenants and events of default. Negative covenants included, among other limitations, limitations on additional debt, liens, asset sales and affiliate transactions. Events of defaults included, among other events, violation of covenants, material breaches of representations, cross default to other material debt, bankruptcy and insolvency and material judgments.
The First Lien Credit Facilities and related security documents were amended on August 13, 2021 to (i) permit the consummation of the Biomat Transactions, (ii) reduce the Guarantor Coverage Test to 60%, and (iii) upon the consummation of the Biomat Transactions, release Biomat USA and Talecris from their respective guarantees provided under the First Lien Credit Facilities and release the liens granted over the assets of Biomat USA and Talecris. The Biomat Transactions were consummated on December 1, 2021, and we used part of the net proceeds therefrom to (i) prepay $600 million of principal amount of the Revolving Loans under the First Lien Credit Facilities, (ii) prepay $142,360,501.31 of the Dollar Tranche B Term Loans and (iii) prepay the Euro equivalent of $88,003,617.48 of the Euro Tranche B Term Loans.
On April 21, 2022 and April 25, 2022, we entered into Counterpart Agreements in connection with the First Lien Credit Facilities to add, respectively, Grifols Escrow Issuer, S.A.U. (the “Escrow Issuer”) (which has since been merged with and into the Company) and Biotest Holdings as guarantors thereunder. On September 28, 2022, we amended and restated the Counterpart Agreement entered into on April 25, 2022 by Biotest Holdings to amend and restate the provisions relating to the guaranty limitations for German guarantors to account for Biotest Holdings conversion from a stock corporation (Aktiengesellschaft) to a limited liability company (Gesellschaft mit beschränkter Haftung).
The First Lien Credit Facilities were amended on May 3, 2023, to provide for the replacement of LIBOR as a reference interest rate by SOFR.
On July 10, 2024, we used a part of the proceeds of the sale of 20% of the equity interests in Shanghai RAAS to prepay an amount of €391,878,662.41 of our Euro Tranche B Term Loans and $673,027,895.20 of our Dollar Tranche B Term Loans.
As of December 31, 2025, we had €860 million and $1.3 billion in aggregate principal amount outstanding of Term Loans, and no amounts outstanding under our Revolving Loans. See Notes 19 and 30 to our consolidated audited financial statements included in this annual report.
On April 14, 2026, we repaid all amounts outstanding under the First Lien Credit Facilities using the proceeds of the New Credit Facilities. See “—New Credit Facilities” above.
The 2019 Notes
On November 15, 2019, we issued €905 million senior secured notes that would have matured on February 15, 2025 and bore interest at 1.625% per annum (the “1.625% Notes”) and €770 million senior secured notes that would have matured on November 15, 2027 and bear interest at 2.250% per annum (the “2.250% Notes” and together with the 1.625% Notes, the “2019 Notes”).
The 2019 Notes were guaranteed on a senior secured basis by the wholly-owned subsidiaries of Grifols that were guarantors and co-borrowers under the First Lien Credit Facilities. Subject to permitted liens, all obligations under the 2019 Notes, and the guarantees of those obligations, were secured on a first-priority basis by the tangible and intangible assets of the domestic guarantors, the blood plasma inventory of GWWO (with the exception of blood plasma inventory located in Spain) and pledges of equity of certain subsidiaries of Grifols (subject to certain exclusions and limitations). The collateral that secured the 2019 Notes also secured the First Lien Credit Facilities, and the EIB Term Loans, and currently secures the New Credit Facilities, the April 2024 Notes and the December 2024 Notes, subject to the Intercreditor Agreement.
The indenture governing the 2019 Notes contained certain covenants limiting, subject to exceptions, carve-outs and qualifications, Grifols’ ability and its restricted subsidiaries’ ability to: (i) pay dividends or make certain other restricted payments or investments; (ii) incur additional indebtedness or provide guarantees of indebtedness and issue disqualified stock; (iii) create liens on assets; (iv) merge, consolidate, or sell all or substantially all of our and our restricted subsidiaries’ assets; (v) enter into certain transactions with affiliates; (vi) create restrictions on dividends or other payments by our restricted subsidiaries; and (vii) create guarantees of indebtedness by restricted subsidiaries. The indenture also contains certain customary events of default.
On November 15, 2019 the 2019 Notes were listed on the Global Exchange Market of the Irish Stock Exchange.
On August 6, 2021, we entered into an indenture supplement amending the indenture governing the 2019 Notes to (i) permit the consummation of the Biomat Transactions, and (ii) upon the consummation of the Biomat Transactions, release Biomat USA and Talecris from their guarantees and collateral provided under the indenture governing the 2019 Notes. The Biomat Transactions were consummated on December 1, 2021, and, on January 11, 2022, we repurchased an aggregate principal amount of €97,535,000 (€67,144,000 of 1.625% Notes and €30,391,000 of 2.250% Notes) of the 2019 Notes under an asset sale offer to bondholders.
On April 21 and April 25, 2022, we entered into indenture supplements amending the indenture governing the 2019 Notes to add, respectively, the Escrow Issuer (which has since merged with and into the Company) and Biotest Holdings as guarantors for the 2019 Notes. On July 21, 2023, we entered into an indenture supplement amending the indenture governing the 2019 Notes to acknowledge that the Escrow Issuer has been merged with and into the Company, thereby releasing the guarantee granted by the Escrow Issuer.
On August 8, 2024, we used a part of the proceeds of the sale of 20% of the equity interests in Shanghai RAAS to redeem an amount of €495,036,000 of the 1.625% Notes. On December 27, 2024, we fully redeemed the remaining outstanding 1.625% Notes using proceeds from the December 2024 Notes, together with cash on hand.
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As of December 31, 2025, the principal amount outstanding under the 2.250% Notes was €740 million. On April 14, 2026, we fully satisfied and discharged the outstanding principal amount of the 2.250% Notes using the proceeds of the New Credit Facilities, and expect the redemption of such Notes to be completed by the end of April 2026. See “—New Credit Facilities” above.
The 2021 Notes
On October 5, 2021, the Escrow Issuer, a newly formed wholly owned subsidiary of Grifols that did not hold or otherwise have any interest in any material assets, issued €1,400,000,000 senior notes that will mature on October 15, 2028 and bear interest at 3.875% per annum (the “Euro notes”) and $705,000,000 senior notes that will mature on October 15, 2028 and will bear interest at 4.750% per annum (the “Dollar notes” and together with the Euro notes, the “2021 Notes”). The 2021 Notes were issued to fund the acquisition of Biotest Holdings (and indirectly Biotest) and a voluntary tender offer for the shares in Biotest not owned by Biotest Holdings.
On the date of issuance of the 2021 Notes, the gross proceeds from the offering were deposited into segregated escrow accounts for the benefit of the holders of the 2021 Notes, to be released upon the fulfillment of the conditions precedent to the Biotest acquisition. Such conditions were fulfilled on April 21, 2022, and the funds were released to the Escrow Issuer Following the successful fulfilment of all conditions precedent therefor. Effective as of June 27, 2023, the Escrow Issuer was merged with and into the Company, the results of such merger being that the Company is the surviving entity, assuming (by operation of law) all assets and obligations of the Escrow Issuer, and the Escrow Issuer ceased to exist (the “Escrow Issuer Merger”).
Prior to the Escrow Issuer Merger, the 2021 Notes remained general unsecured obligations of the Escrow Issuer unconditionally guaranteed on a senior unsecured basis by the Company and each of our wholly-owned subsidiaries that that are guarantors and co-borrowers under the First Lien Credit Facilities. From and after the Escrow Issuer Merger, the 2021 Notes became general unsecured obligations of the Company and are unconditionally guaranteed on a senior unsecured basis by our wholly-owned subsidiaries that are guarantors and co-borrowers under the First Lien Credit Facilities.
We are not required to make mandatory redemption or sinking fund payments with respect to the 2021 Notes.
If we experience a change of control, we must give holders of the 2021 Notes the opportunity to sell to us their 2021 Notes at 101% of their principal amount, plus accrued and unpaid interest.
Grifols and the guarantors of the 2021 Notes may incur additional indebtedness if the fixed charge coverage ratio (as defined in the indenture governing the 2021 Notes) for Grifols and the restricted subsidiaries (as defined in the indenture governing the 2021 Notes) on a consolidated basis for the most recently ended four full fiscal quarters immediately preceding the date on which such additional indebtedness is incurred would have been at least 2.00 to 1.00, determined on a pro forma basis.
The indenture governing the 2021 Notes contains certain covenants limiting, subject to exceptions, carve-outs and qualifications, Grifols’ ability and its restricted subsidiaries’ ability to: (i) pay dividends or make certain other restricted payments or investments; (ii) incur additional indebtedness or provide guarantees of indebtedness and issue disqualified stock; (iii) create liens on assets; (iv) merge, consolidate, or sell all or substantially all of our and our restricted subsidiaries’ assets; (v) enter into certain transactions with affiliates; (vi) create restrictions on dividends or other payments by our restricted subsidiaries; and (vii) create guarantees of indebtedness by restricted subsidiaries. The indenture also contains certain customary events of default.
On October 11, 2021 the 2021 Notes were listed on the Global Exchange Market of the Irish Stock Exchange.
On September 28, 2022, we entered into an indenture supplement amending the indenture governing the 2021 Notes to add Biotest Holdings as guarantor for the 2021 Notes. On July 21, 2023, we entered into an indenture supplement amending the indenture governing the 2021 Notes to acknowledge that the Escrow Issuer has been merged with and into the Company, and that the company became the issuer of the 2021 Notes, assuming all obligations previously held by the Escrow Issuer. On April 14, 2026, we entered into a supplemental indenture amending the indenture governing the 2021 Notes to add Grifols International Services Designated Activity Company and Grifols International Services USA Inc. as guarantors for the 2021 Notes.
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A. The Dollar notes
The Dollar notes accrue interest at the rate of 4.750% per annum pay interest semi-annually in arrears on April 15 and October 15, commencing on April 15, 2022. We may redeem the Dollar notes, in whole or in part, at any time at the redemption prices (expressed as percentages of principal amount) set forth below plus accrued and unpaid interest, if any, on the Dollar notes redeemed, to the applicable redemption date (subject to the right of holders of the Dollar notes on the relevant record date to receive interest due on the relevant interest payment date):
Fiscal Year
Percentage
Prior to October 15, 2026
101.188
On or after October 15, 2026
100.000
As of the date of this annual report, the principal amount outstanding under the Dollar Notes is $705 million.
B. The Euro notes.
The Euro notes accrue interest at the rate of 3.875% per annum pay interest semi-annually in arrears on April 15 and October 15, commencing on April 15, 2022. We may redeem the Euro notes, in whole or in part, at any time at the redemption prices (expressed as percentages of principal amount) set forth below plus accrued and unpaid interest, if any, on the Euro notes redeemed, to the applicable redemption date (subject to the right of holders of the Euro notes on the relevant record date to receive interest due on the relevant interest payment date):
100.969
As of the date of this annual report, the principal amount outstanding under the Euro Notes is €1.3 billion.
The April 2024 Notes
On April 30, 2024, Grifols issued €1.0 billion senior secured notes that will mature on May 1, 2030 and bear interest at 7.500% per annum. On June 4, 2024, Grifols issued an additional €300 million of senior secured notes under the same indenture and the same series the notes issued on April 30, 2024 (collectively, the “April 2024 Notes”).
The April 2024 Notes are currently guaranteed on a senior secured basis by the wholly-owned subsidiaries of Grifols that were guarantors and co-borrowers under the First Lien Credit Facilities. Subject to permitted liens, all obligations under the April 2024 Notes, and the guarantees of those obligations, are secured on a first-priority basis by the tangible and intangible assets of the domestic guarantors, the blood plasma inventory of GWWO (with the exception of blood plasma inventory located in Spain) and pledges of equity of certain subsidiaries of Grifols (subject to certain exclusions and limitations). The collateral securing the April 2024 Notes also secures the December 2024 Notes and the New Credit Facilities, subject to the Intercreditor Agreement.
On April 14, 2026, we entered into a supplemental indenture amending the indenture governing the April 2024 Notes to add Grifols International Services Designated Activity Company and Grifols International Services USA Inc. as guarantors for the April 2024 Notes.
We are not required to make mandatory redemption or sinking fund payments with respect to the April 2024 Notes.
If we experience a change of control, we must give holders of the April 2024 Notes the opportunity to sell to us their April 2024 Notes at the redemption prices set forth below, plus accrued and unpaid interest.
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Grifols and the guarantors of the April 2024 Notes may incur additional indebtedness if the fixed charge coverage ratio (as defined in the indenture governing the April 2024 Notes) for Grifols and the restricted subsidiaries (as defined in the indenture governing the April 2024 Notes) on a consolidated basis for the most recently ended four full fiscal quarters immediately preceding the date on which such additional indebtedness is incurred would have been at least 2.00 to 1.00, determined on a pro forma basis. In addition, Grifols and the guarantors of the April 2024 Notes may incur additional secured indebtedness if the secured leverage ratio (as defined in the indenture governing the April 2024 Notes) for Grifols and the restricted subsidiaries (as defined in the indenture governing the April 2024 Notes) on a consolidated basis for the most recently ended four full fiscal quarters immediately preceding the date on which such additional indebtedness is incurred would not exceed 4.50 to 1.00, determined on a pro forma basis.
The indenture governing the April 2024 Notes contains certain covenants limiting, subject to exceptions, carve-outs and qualifications, Grifols’ ability and its restricted subsidiaries’ ability to: (i) pay dividends or make certain other restricted payments or investments; (ii) incur additional indebtedness or provide guarantees of indebtedness and issue disqualified stock; (iii) create liens on assets; (iv) merge, consolidate, or sell all or substantially all of our and our restricted subsidiaries’ assets; (v) enter into certain transactions with affiliates; (vi) create restrictions on dividends or other payments by our restricted subsidiaries; and (vii) create guarantees of indebtedness by restricted subsidiaries. The indenture also contains certain customary events of default.
The April 2024 Notes accrue interest at the rate of 7.500% per annum pay interest semi-annually in arrears on May 1 and November 1, commencing on November 1, 2024. We may redeem the April 2024 Notes, in whole or in part, at any time on and after May 1, 2026 at the redemption prices (expressed as percentages of principal amount) set forth below plus accrued and unpaid interest, if any, on the notes redeemed, to the applicable redemption date (subject to the right of holders of the notes on the relevant record date to receive interest due on the relevant interest payment date), if redeemed during the twelve-month period beginning on May 1 of the years indicated below:
2026
104.000
2027
102.000
2028 and thereafter
If we experience a change of control, we must give holders of the April 2024 Notes the opportunity to sell to us their April 2024 Notes at the redemption prices set forth under the paragraph above, plus accrued and unpaid interest.
If we redeem the April 2024 Notes prior to May 1, 2026, the redemption price shall be equal to 100% of the principal amount of the April 2024 Notes redeemed plus the Applicable Premium as of, and accrued and unpaid interest, if any, to but excluding, the redemption date. The “Applicable Premium” shall be determined by the Issuer as the greater of (i) 4.0% of the principal amount of such redeemed April 2024 Notes; and (ii) the excess, if any, of (a) the present value at such redemption date of (x) the redemption price of such April 2024 Notes, as applicable, at May 1, 2026 (as stated in the table above), plus (y) all required interest payments due on such April 2024 Notes through May 1, 2026 (excluding accrued but unpaid interest to the redemption date), computed using a discount rate at the Bund Rate (or, if greater than such Bund Rate, zero), in each case as of such redemption date plus fifty (50) basis points, over (b) the principal amount of such April 2024 Notes.
We used the proceeds of the April 2024 Notes to (i) fully redeem, on May 27, 2024, the total principal amount outstanding of the senior notes issued in 2017, which would have otherwise matured on May 1, 2025, and (ii) to repay outstanding amounts under our revolving credit facility under the First Lien Credit Facilities.
On July 11, 2024, the April 2024 Notes were listed on the Global Exchange Market of the Irish Stock Exchange.
In November 2025, we conducted a consent solicitation process whereby we obtained the support of approximately 95% of holders of our April 2024 Notes to approve an amendment to the indenture for such notes, which enhances our financial flexibility and facilitates more efficient management of our capital structure, in line with our previously announced refinancing plans. The relevant supplemental indenture was executed on November 13, 2025. See “—A. Operating Results—Subsequent Events—Refinancing Plans” above.
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As of the date of this annual report, the principal amount outstanding under the April 2024 Notes is €1.3 billion. However, we have delivered to the holders of the April 2024 Notes a conditional notice of redemption to redeem, subject to certain conditions, €500 million in principal amount of the April 2024 Notes.
The December 2024 Notes
On December 19, 2024 Grifols issued €1.3 billion senior secured notes that will mature on May 1, 2030 and bears interest at 7.125% per annum (the “December 2024 Notes”).
The December 2024 Notes are currently guaranteed on a senior secured basis by the wholly-owned subsidiaries of Grifols that were guarantors and co-borrowers under the First Lien Credit Facilities. Subject to permitted liens, all obligations under the December 2024 Notes, and the guarantees of those obligations, are secured on a first-priority basis by the tangible and intangible assets of the domestic guarantors, the blood plasma inventory of GWWO (with the exception of blood plasma inventory located in Spain) and pledges of equity of certain subsidiaries of Grifols (subject to certain exclusions and limitations). The collateral securing the December 2024 Notes also secures the April 2024 Notes and the New Credit Facilities, subject to the Intercreditor Agreement.
On April 14, 2026, we entered into a supplemental indenture amending the indenture governing the December 2024 Notes to add Grifols International Services Designated Activity Company and Grifols International Services USA Inc. as guarantors for the December 2024 Notes.
We are not required to make mandatory redemption or sinking fund payments with respect to the December 2024 Notes.
Grifols and the guarantors of the December 2024 Notes may incur additional indebtedness if the fixed charge coverage ratio (as defined in the indenture governing the December 2024 Notes) for Grifols and the restricted subsidiaries (as defined in the indenture governing the December 2024 Notes) on a consolidated basis for the most recently ended four full fiscal quarters immediately preceding the date on which such additional indebtedness is incurred would have been at least 2.00 to 1.00, determined on a pro forma basis. In addition, Grifols and the guarantors of the December 2024 Notes may incur additional secured indebtedness if the secured leverage ratio (as defined in the indenture governing the December 2024 Notes) for Grifols and the restricted subsidiaries (as defined in the indenture governing the December 2024 Notes) on a consolidated basis for the most recently ended four full fiscal quarters immediately preceding the date on which such additional indebtedness is incurred would not exceed 4.50 to 1.00, determined on a pro forma basis.
The indenture governing the December 2024 Notes contains certain covenants limiting, subject to exceptions, carve-outs and qualifications, Grifols’ ability and its restricted subsidiaries’ ability to: (i) pay dividends or make certain other restricted payments or investments; (ii) incur additional indebtedness or provide guarantees of indebtedness and issue disqualified stock; (iii) create liens on assets; (iv) merge, consolidate, or sell all or substantially all of our and our restricted subsidiaries’ assets; (v) enter into certain transactions with affiliates; (vi) create restrictions on dividends or other payments by our restricted subsidiaries; and (vii) create guarantees of indebtedness by restricted subsidiaries. The indenture also contains certain customary events of default.
The December 2024 Notes accrue interest at the rate of 7.125% per annum pay interest semi-annually in arrears on May 1 and November 1, commencing on May 1, 2025. We may redeem the December 2024 Notes, in whole or in part, at any time on and after May 1, 2026 at the redemption prices (expressed as percentages of principal amount) set forth below plus accrued and unpaid interest, if any, on the notes redeemed, to the applicable redemption date (subject to the right of holders of the notes on the relevant record date to receive interest due on the relevant interest payment date), if redeemed during the twelve-month period beginning on May 1 of the years indicated below:
If we experience a change of control, we must give holders of the December 2024 Notes the opportunity to sell to us their December 2024 Notes at the redemption prices set forth under the paragraph above, plus accrued and unpaid interest.
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If we redeem the December 2024 Notes prior to May 1, 2026, the redemption price shall be equal to 100% of the principal amount of the December 2024 Notes redeemed plus the Applicable Premium as of, and accrued and unpaid interest, if any, to but excluding, the redemption date. The “Applicable Premium” shall be determined by the Issuer as the greater of (i) 4.0% of the principal amount of such redeemed December 2024 Notes; and (ii) the excess, if any, of (a) the present value at such redemption date of (x) the redemption price of such December 2024 Notes, as applicable, at May 1, 2026 (as stated in the table above), plus (y) all required interest payments due on such December 2024 Notes through May 1, 2026 (excluding accrued but unpaid interest to the redemption date), computed using a discount rate at the Bund Rate (or, if greater than such Bund Rate, zero), in each case as of such redemption date plus fifty (50) basis points, over (b) the principal amount of such December 2024 Notes.
We used the proceeds of the December 2024 Notes to (i) together with cash on hand, fully redeem, on December 27, 2024, the total principal amount outstanding of the 1.625% Notes, which would have otherwise matured on February 15, 2025, and (ii) to fully repay then-outstanding revolving loans under the First Lien Credit Facilities.
As of the date of this annual report, the principal amount outstanding under the December 2024 Notes is €1.3 billion.
The Biomat Transactions
On December 1, 2021, we sold preferred shares representing 12.9% of Biomat Newco and 12.5% of Biomat USA, our U.S.-based plasma collection subsidiaries that are part of the Biomat Group, to the GIC Investor. Specifically, the GIC Investor acquired preferred shares. The purchase price received was $990 million.
As a result of the transaction, the GIC Investor received ten class B common shares of Biomat USA and nine class B common shares of Biomat Newco. While named common shares, such shares are non-voting and have annual preferential dividends of $4,168,421.05 per share of Biomat USA and Biomat Newco. These preferred shares also granted the GIC Investor with redemption rights of up to one share per year beginning in 2023 at $52,105,263.16 per share. This investment was originally recorded as equity, but was later restated as debt in our consolidated financial statements for the year ended December 31, 2021, prepared under pursuant to IFRS-EU and filed with the CNMV in Spain. As of December 31, 2025, the investment by the GIC Investor is still recorded as debt in our consolidated financial statements, and the reclassification did not affect compliance with the covenants under our debt instruments.
The GIC Investor has exercised its right to redeem one class B common share of Biomat Newco, at the redemption price of $52,105,263.16, on each of the years ended December 31, 2023, 2024 and 2025. See Note 19(d) to our consolidated financial statements as of and for the year ended December 31, 2025, included in this annual report on Form 20-F.
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Other Debt
Within the context of the acquisition of plasma collection centers from ImmunoTek, on February 3, 2025, our subsidiary Biomat Holdings LLC issued a promissory note in favor of ImmunoTek in an amount of $70 million (which represents the outstanding balance of the purchase price for six plasma collection centers acquired by Biomat Holdings LLC, in the amount of $62 million, plus management fees of approximately $8 million), with no interest accrual. The promissory note matured on January 3, 2026, date on which it was fully settled. See “—A. Operating Results—Factors Affecting our Financial Condition and Results of Operations— Acquisition of Plasma Collection Centers From ImmunoTek.”
In June 2024, our subsidiary Grifols Canada Therapeutics Inc. (“Grifols Canada”) obtained a loan facility from Investissement Québec, a governmental financial institution fomenting investments in Quebec, in an amount up to CAD$36,000,000. Grifols Canada is using the proceeds of this loan to finance the upgrades and start of operations related to the upsize in the production capacity of its therapeutics production plant in Montreal. Pursuant to this loan, Grifols Canada shall fulfill the following objectives (“Targets”) in relation to the Montreal plant: (1) create, by May 31, 2027 and maintain throughout the term of the loan at least 184 permanent jobs generating (2) an average gross annual salary of CAD$78,700 and (3) incur certain eligible expenditures agreed with the lender (the earlier of the date the Targets are completed or May 31, 2027, the “Project Completion Date”).
The loan will be repaid in 60 monthly instalments of CAD$450,000, starting on the earlier of (i) the Project Completion Date; or (ii) the fifth anniversary of the first drawdown. The principal amount of the loan will be reduced by the lower of CAD$9,000,000 and 25% of the eligible expenditures disbursed in the project if Grifols Canada fulfills at least 75% of the Targets. If Grifols Canada fulfills at least 50% of the Targets, no interest will accrue on the loan. If Grifols Canada fails to complete 50% of the Targets, the loan will bear interest at the prime rate of Investissement Québec plus 3.0% per annum, accrued retroactively from the first disbursement of the loan. This loan is secured with a real estate mortgage over Grifols Canada’s Montreal plant, as well as a comfort letter from Grifols S.A. As of December 31, 2025, no amount had been drawn under this loan.
Certain other debt instruments, including credit facilities and lease obligations, are in place with various lenders and consist of long-term and short-term indebtedness of both us and Grifols subsidiaries. As of December 31, 2025, such other debt included an unsecured long-term loan in the amount of €46 million corresponding to our subsidiary Biotest, as well as distributor commission liabilities of €14 million, also corresponding to Biotest.
See Note 19 to our consolidated audited financial statements included in this annual report.
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For detailed information regarding our research and development initiatives, see Item 4 of this Part I, “Information on the Company—B. Business Overview—Research and Development.”
Plasma-derived protein therapies are essential to extend and improve the lives of individuals suffering from chronic, acute and life-threatening conditions including infectious diseases, such as hepatitis, immunological diseases, such as multiple sclerosis, hemophilia, Von Willebrand Disease, liver dialysis and acute conditions such as burns and severe blood loss. For this reason, the administration of these products cannot be interrupted or postponed without putting patients’ lives at risk. This ensures a stable demand for such products. In addition, because of the nature of the diseases treated, the reimbursement rates for plasma derivative products in the United States are high. Any changes to such rates would likely elicit a strong lobbying response in the United States.
Based on MRB reports, in 2024, the worldwide plasma proteins market (without recombinant products) exceeded $35.0 billion, an increase of approximately 20% from 2021. In 2024, more than 18.5 million people across the globe received a plasma derived protein product, including 1.2 million people in the United States and 8.8 million people in China. Overall, hyperimmune products globally were responsible for over 70.0% of the patients who used plasma derived products, or 14.5 million people in 2024. Globally, over 800,000 people received IgG (IVIG or SCIG), with over 25.0% of that total, or over 200,000 people, receiving IgG in the United States in 2024. Given that over 85% of plasma used for fractionation comes from source plasma, over 16 million of the plasma derived product patients rely on plasma collected by Plasmapheresis.
The significant multi-decade growth has mainly been caused by new patients diagnosed and starting therapy with IgG, albumin and other plasma proteins. Even though only 1 new plasma protein (plasminogen) has been introduced in the past ten years, the plasma industry is expected to continue expanding due to higher usage of core plasma proteins such as IgG as well as geographic expansion. While growth rates vary by region and product category, we believe that global demand for plasma-derived therapies will continue to increase over the long term, as many plasma derivative products are underutilized, particularly in emerging markets, and will continue to benefit from strong demand. Additionally, new indications are being explored for a number of plasma-derived therapies, such as the treatment of Alzheimer’s disease.
We believe that the volume of global sales of plasma derivative products will continue to grow driven primarily by the same factors that have contributed to its historical growth, including:
In 2025, 21.5% of our sales were generated in the European Union, as compared to 21.4% in 2024 and 19.1% in 2023.
There are significant barriers to entry into the plasma derivative products industry, as the industry is highly regulated and requires significant expertise and capital investments. We do not expect these barriers to decrease in the near term.
Regulatory Environment. In order to operate in the plasma derivatives industry, manufacturers and distributors must comply with extensive regulation by the FDA, the EMA and comparable authorities worldwide. As a result, significant investments are required to develop, equip and maintain the necessary storage, fractionation and purification facilities and to develop appropriate sale, marketing and distribution infrastructures. Additionally, only proteins derived from plasma collected at FDA-approved centers can be marketed in the United States, so securing an adequate supply of U.S. source plasma is required to operate in the United States. We expect these regulatory restrictions to continue.
Product Pipeline.
We have an expanded portfolio of key products as a result of our recent acquisitions and will continue to invest in research and development with respect to new product and new indications for existing products. Some key research and development projects underway include clinical studies of the use of albumin, diagnostic and vaccine therapies to treat Alzheimer’s disease, of albumin to treat advance Cirrhosis and ascites, and of antithrombin in heart surgery.
Our product pipeline offers a strategic balance between risk and value across diverse phases. In 2025 we had 87 Biopharma initiatives in development and more than 80 Diagnostic projects in our pipeline. In 2023, our subsidiary Biotest achieved positive results in its Phase III clinical trial for fibrinogen concentrate, marking a significant step in treating acquired fibrinogen deficiency. Other innovations reinforce our position in plasma-derived medicine, such as IG Yimmugo, a newly developed immunoglobulin for the treatment of immunodeficiencies and autoimmune diseases, and Trimodulin, an antibody composition purified from human plasma in clinical development to treat severe community-acquired pneumonia (sCAP) and severe COVID-19.
The preparation of consolidated financial statements in accordance with IFRS requires us to make estimates and judgments in certain circumstances that affect the reported amounts of assets, liabilities, revenue, expenses and the related disclosures of contingent assets and liabilities. A detailed description of our significant accounting estimates is included in the notes to our audited consolidated financial statements included elsewhere in this annual report on Form 20-F.
Certain of our significant accounting policies require subjective and complex judgments, often requiring the use of estimates about the effects of matters that are inherently uncertain. We apply estimation methodologies consistently from year to year. Other than changes required due to the issuance of new accounting guidance, there have been no significant changes in our application of critical accounting estimates during the periods presented. We periodically review our critical accounting estimates and estimates with the Audit Committee of our Board.
These accounting policies include depreciation, subsequent recognition, impairment, goodwill and amortization, among others. See Notes 2, 4 and 6 to our audited consolidated financial statements included in this annual report on Form 20-F for more information regarding our critical accounting estimates and Goodwill, respectively.
More information on recently issued accounting standards is included in Note 2 to our audited consolidated financial statements included in this annual report on Form 20-F.
Directors
From January 2025 until the date of this annual report, the following changes were made to our Board of Directors:
Set forth below are the names and current positions of the members of the Board:
Name
Age
Title
Type
DirectorSince
TermExpires
José Ignacio (Nacho) Abia Buenache
Director and Chief Executive Officer
Executive
Feb 2024
June 2028
Anne-Catherine Berner
Director, Non-Executive Chairperson
Independent
June 2024
Raimon Grifols Roura
Director, Vice-Chairperson
Proprietary
May 2015
June 2027
Víctor Grifols Deu
Director
May 2016
June 2029
Tomás Dagá Gelabert
Other External
Apr 2000
Enriqueta Felip Font
May 2019
Montserrat Muñoz Abellana
June 2022
June 2026
Susana González Rodríguez
Pascal Ravery
Dec 2024
Iñigo Sánchez-Asiaín Mardones
Albert Grifols Coma-Cros
Dec 2023
Paul S. Herendeen
Laura de la Cruz Galán
Secretary, non-member
n/a
Núria Martín Barnés
Vice-Secretary, non-member
Director Biographies
Mr. Jose Ignacio (Nacho) Abia Buenache serves as board member of Grifols, S.A. since February 2024, having assumed the office of Chief Executive Officer of the Company on April 1, 2024. Previously, he was President and Chief Executive Officer of Olympus Corporation of the Americas, based in Pennsylvania, for over 10 years. He also served as Executive Officer and COO and CSO at Olympus Corporation, a publicly traded company in the Tokyo stock exchange. Mr. Abia has over two decades of experience in the medical technology and life sciences industries, with half of that time spent in the United States and the other half in Europe, while also spending significant time in the Asia-Pacific region to develop businesses. Prior to joining Olympus, he held several positions in the information technologies and consumer electronics industries working for a variety of technology companies, including Sony and Techdata.
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In the academic field, Nacho holds a Bachelor’s Degree in Telecommunications and Electronics Engineering from the Universitat Politécnica de Catalunya (UPC), a Master of Business Administration (MBA) degree from the business school (EAE) of Barcelona, and has completed the Senior Management Program (PADE) at IESE (University of Navarra). Mr. Abia also serves on the board of directors of the U.S.-Spain Chamber of Commerce and is also a member of the board of trustees of the Lehigh Valley Health Network, a hospital system composed of 13 hospitals and multiple care centers in Pennsylvania. In the past, he was a member of the board of directors of Evident Corporation, a company in the field of life sciences and industrial solutions.
Mrs. Anne-Catherine Berner has served as a director of Grifols since 2024 and currently she is the Non-Executive Chairperson of the Board. Mrs. Berner brought executive and non-executive experience across the financial, healthcare, and industrial sectors. Her professional journey encompasses leadership roles in various publicity listed and privately held international companies and organizations across multiple sectors, highlighting finance. Before joining our Board, Mrs. Berner served from 1989 until 2012 as Chief Executive Officer and Chairperson of the Board of Vallila Interior AB, a family-owned interior design company. Mrs. Berner also served as a Member of the Finnish Parliament and as Minister for Transport and Communications in the Finnish government from 2015 to 2019. Mrs. Berner also has expertise as a board member and Chairperson in various industries, including forestry and paper, insurance, and building materials. She currently serves as a board member of Kühne + Nagel AG, a global transport and logistics company, and SEB AB, a public Nordic financial services group. Since 2022, she has chaired the Advisory Board of Getec Energie Holding GmbH, a prominent energy services provider in Germany. In addition, she joined the Board of Medicover AB in 2022, focusing on healthcare and diagnostic services in Central and Eastern Europe. Mrs. Berner is also the Chairwoman of the Board of the Foundation for Children’s Trauma Hospital and Institution Nadija sr, in Helsinki. Mrs. Berner holds a Master of Science degree in Business Administration and Economics from the Hanken School of Economics in Helsinki, Finland.
Mr. Raimon Grifols Roura has served as director of Grifols since 2015 and as Vice-Chairperson of the Board since February 2023. He was Grifols’ joint and several Chief Executive Officer together with Mr. Víctor Grifols Deu from 2017 to May 2023. He succeeded his brother, Mr. Víctor Grifols Roura in the position. Likewise, he held the position of Chief Corporate Officer from May 2023 to May 2024. From 2001 to 2015 he held the role of secretary, non-member, of the Board of Directors of Grifols, and in 2015 began serving as director and Vice Secretary of the Board of Directors. In May 2016, the Board accepted his resignation as Vice Secretary. Until his appointment as executive director in July 2016, Mr. Grifols Roura was a partner at the law firm Osborne Clarke in Spain. Mr. Grifols Roura earned his law degree from the University of Barcelona (Universidad de Barcelona).
Mr. Raimon Grifols Roura is a director and shareholder of Deria S.L. (a non-controlling shareholder, pursuant to the Spanish Securities Market Act). He is also a shareholder of Scranton Enterprises, B.V. (a non-controlling shareholder, pursuant to the Spanish Securities Market Act).
Mr. Víctor Grifols Deu has served as director of Grifols since 2016. He was Grifols’ joint and several Chief Executive Officer together with Mr. Raimon Grifols Roura from 2017 to May 2023. He succeeded his father, Mr. Víctor Grifols Roura in the position. He held the position of Chief Operating Officer from May 2023 to May 2024. He joined the Company in 2001 as an analyst in the Planning and Control Department of the Company. In 2008 he became the director of the Planning and Control Department and was also appointed a member of the Executive Committee. He has been part of the team that analyzed and was responsible for the integration of operations after the acquisition of Alpha Therapeutics, Talecris Biotherapeutics and Novartis’ Transfusion Diagnostic Unit. He graduated in Business Administration and Management from the Ramon Llull University — Sarrià Chemical Institute and holds a postgraduate degree in Business Administration and Management from Michael Smurfit Business School in Dublin.
Mr. Víctor Grifols Deu is a director and shareholder of Deria S.L. (a non-controlling shareholder, pursuant to the Spanish Securities Market Act).
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Mr. Tomás Dagá Gelabert has served as director of Grifols since April 2000 and was also our Vice Secretary of the Board from May 2016 to December 2023. He is a founder of the law firm Osborne Clarke in Spain where he was a partner until December 2024. He was the managing partner of the law firm Osborne Clarke in Spain until June 30, 2017. Prior to joining Osborne Clarke, he worked in the corporate and tax department of Peat Marwick Mitchell & Co. in Barcelona. His professional career has provided him with a wide range of accounting, financial and audit skills. Mr. Dagá earned his law degree from the University of Barcelona (Universidad de Barcelona).
Mr. Tomás Dagá Gelabert is a shareholder of Scranton Enterprises, B.V. (a non-controlling shareholder, pursuant to the Spanish Securities Market Act).
Dr. Enriqueta Felip Font has served as a director of Grifols since May 2019. She received her degree in Medicine and Surgery from the Autonomous University of Barcelona (UAB), where she also completed her studies for a PhD in Medical Oncology. She was an Associate Professor at the UAB from 2010 to May 2019. She has been a Professor of Medicine at the Universitat de Vic (UVicc-UCC) and since March 2024, she is a Professor at the UAB. Dr. Felip Font has an extensive professional career and accredited experience in the oncology sector, as well as knowledge in the scientific and research field. She is currently the Section Chief of the Medical Oncology Service at Vall d’Hebron University Hospital and the Principal Investigator of the Vall d’Hebron Institute of Oncology’s Thoracic Tumors Cancer Group. Dr. Enriqueta Felip Font has made a significant contribution to cancer research, especially in the field of thoracic tumors, and has collaborated in the development of lung cancer approaches that define the current standard of care for the disease. Dr. Enriqueta Felip Font has been involved in several initiatives with scientific organizations, among them, as member of the Board of Directors of the International Association for the Study of Lung Cancer (IASLC, 2017-2021). She is currently member of the Scientific Committee of the Institut d’Investigació i Innovació Parc Taulí. Throughout her career, she has obtained several recognitions for her work in the oncology field. In 2015, she was awarded with the first Women for Oncology Award from the European Society of Medical Oncology (ESMO). In May 2022 she was awarded with the Prize “La Vanguardia de la Ciencia.” In March 2024, she was awarded with the “Heine H. Hansen” recognition, which acknowledges lung cancer investigators who have made a significant contribution to lung cancer research and education on an international basis and is jointly bestowed by ESMO and the IASLC.
Most recently, she featured on Clarivate Analytics’ annual Global Highly Cited Researchers List 2018, 2019, 2020, 2021, 2022, 2023, 2024 and 2025. Dr. Enriqueta Felip Font has authored more than 350 peer-reviewed articles. Her professional background has provided her with expertise and knowledge on scientific and innovation matters.
Ms. Muñoz Abellana earned a degree in Chemical Engineering from the Institut Químic de Sarrià in Barcelona (Universitat Ramon Lull) and several Executive Development Programs at IESE, INSEAD and the London Business School.
She began her professional career in the Consumer Goods sector at Procter & Gamble where she held different roles in Operations across Europe. For the last 17 years and until end of 2022, she has been a Senior Executive at Danone where she has served as Global Medical Nutrition Operations Vice President, Iberia Medical Nutrition General Manager and Value Chain Digital Transformation Vice President.
Ms. Muñoz Abellana is also an independent director and the Chairperson of the Audit and Compliance Committee at Uriach, independent director and Chairperson of the Appointments and Remuneration Committee at Comexi, independent director at Coplus 1930 and was Chairperson of the Supervision Committee at Eole Holdings until December 2025. Her professional background has provided her with expertise and knowledge on operations, strategy and digital transformation matters, as well as accounting, financial and audit skills.
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Ms. González Rodríguez earned a degree in Business Administration from the Asturias Business School and an MBA from the San Francisco State University. She has a professional career in the electronics industry and industrial automation sector. She began her professional career in the electronics industry sector at TE Connectivity, Rockwell Automation and ABB Group where she held different roles. She is a member of the Supervisory Board of Lely, effective April 1, 2026. Likewise, she is a member of the Spanish Board Directors (Instituto de Consejeros-Administradores). Her professional background has provided her with expertise and knowledge on strategy, sales and digital transformation matters.
Mr. Iñigo Sánchez-Asiaín Mardones has been the Lead Independent director of the Board since May 2015 until 2022 and he has served as director of Grifols, S.A. since May 2015. He earned a degree in Business Administration from the Universidad Pontificia de Comillas in Madrid (ICADE) and an MBA from Harvard Business School. In 2010 he founded Portobello Capital, a private equity firm, where he remains a partner and a member of the Executive Committee and Investment Committee, leading the investments in companies such as Angulas Aguinaga, a company where he is Vice-Chairman and member of the Executive Committee, and Hotels & Resorts Blue Sea, S.L., where he is a member and Chairperson of the Board of Directors. He is also a member of the Executive Committee at the Harvard Club of Spain, which he has previously chaired. Previously, from 1993 to 2005, he was Deputy General Director at Banco Santander and from 2005-2010 was a partner and member of the board of directors of Ibersuizas Gestión SGECR, S.A, through which, together with his academic training, he has gained experience and knowledge on matters such as accounting, audit and risk management, both financial and non-financial.
Mr. Albert Grifols Coma-Cros joined the Grifols Group in 2004 as an analyst in the Planning and Control Department. In 2007, he moved to the Finance Department as a financial analyst. In 2013, Mr. Grifols Coma-Cros held the position of Corporate Treasury Director and moved to Ireland to develop and implement the Group’s global financial structure. From 2018 to 2020, he was appointed Managing Director of Grifols Worldwide Operations Limited in Ireland, ensuring the correct collusion between Irish culture and Grifols’ own values in the gradual growth of our subsidiary in the country. From 2021 to 2023, Mr. Grifols Coma-Cros served as Chief Scientific Innovation Officer, being responsible for consolidating all of the Grifols Group’s scientific knowledge previously dispersed under a single scientific organization. He holds a degree in Business Administration from the Universitat Autònoma de Barcelona and has completed several Management Development Programs at ESADE, Georgetown University or the Institut Estudis Financers (IEF).
Mr. Grifols Coma-Cros has also been a director of the board of directors of Fisa 14, S.A., a real estate company, since 2015, and president of Bansabadell 18, FP, a pension fund, from 2018 to 2024. Since September 2025, he has served as the Chief Executive Officer at Ponder Trade, S.L. (a non-controlling shareholder, pursuant to the Spanish Securities Market Act).
Mr. Pascal Ravery has served as a director of Grifols since December 2024. He has an extensive professional background in corporate finance and investment banking, with expertise in mergers and acquisitions, restructuring, and strategic advisory across various industries and regions. He has experience as a C-Suite and Board advisor in both publicly listed and private companies, as well as serving as a Non-Executive Board Member of private companies. Mr. Ravery began his career in finance at 3i Group, a British multinational private equity and development capital firm, where he worked from 1981 to 1983. He then joined Goldman Sachs, specializing in mergers and acquisitions and corporate finance in the United States and the United Kingdom, playing a key role in privatizations, major mergers, and IPOs for corporations and state-owned enterprises from 1985 to 1992.
In 1992, Mr. Ravery joined J.P. Morgan as Managing Director and Head of Industrials in Europe, ultimately becoming Vice-Chairman of the Investment Banking division in 2008. In 2012, he was appointed chief executive officer and chairman of the management committee of J.P. Morgan Securities in Switzerland. In 2015, Mr. Ravery founded Lakeside Capital Advisers, a corporate finance consultancy based in Baar, Switzerland, where he currently serves as CEO. Mr. Ravery is a graduate of INSEAD’s MBA program and the INSEAD independent director’s program.
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Mr. Paul S. Herendeen has served as a director of Grifols since December 2024. He currently serves as a board member of Elanco Animal Health, Inc, where he is the Chair of the Finance, Strategy and Oversight Committee. He was the Chairman of Endo, Inc. until its merger with Mallinckrodt in August of 2025. Mr. Herendeen has served as advisor to the chairman and chief executive officer of Bausch Health Companies Inc., where he also served as executive vice president and chief financial officer. Prior to that, he was executive vice president and chief financial officer of Zoetis Inc. He also held the position of chief financial officer at Warner Chilcott, a specialty pharmaceuticals company, after rejoining the firm following four years as executive vice president and chief financial officer of MedPointe.
Mr. Herendeen also has several years of experience in the finance, investment banking, and public accounting sectors. He worked as a principal investor at Dominion Income Management and Cornerstone Partners. Earlier in his career he held various positions in banking and public accounting, including roles in the investment banking group at Oppenheimer & Company, the capital markets group at Continental Bank Corporation, and as a senior auditor at Arthur Andersen & Company. He holds a bachelor’s degree from Boston College and an MBA from the University of Virginia’s Darden School of Business.
Mr. Paul S. Herendeen represents FF Hybrid LP, Flat Footed Series LLC-Fund3, GP Recovery Fund LLC, Mason Capital Master Fund, L.P., Sachem Head Master LP, SH Stony Creek Master and Sachem Head LP (non-controlling shareholders, pursuant to the Spanish Securities Market Act) at the Board.
Biography of the Secretary and Vice-Secretary, Non-Members, of the Board
Ms. Laura de la Cruz Galán has been serving as Secretary, non-member, of the Board of Directors since January 1, 2026. She previously served as the Vice-Secretary, non-member, of our Board from December 2023 to December 2025. Laura has also been serving as the Secretary, non-member, of our Audit Committee since April 2024. She is a Partner of the Spanish law firm Osborne Clarke, where she has been a lawyer since 2012. Ms. De la Cruz specializes in corporate governance with respect to listed companies, as well as international M&A transactions. She holds a Law Degree from ESADE Law School in Barcelona, where she graduated in 2011. In 2023, she was selected to join the 8th edition of the “Women’s Talent Pool Leadership Programme” organized by the European Network for Women in Leadership. Furthermore, she is a trustee and Secretary of the Board of Trustees of Fundació Víctor Grifols i Lucas.
Ms. Núria Martín Barnés served as Vice-Secretary non-member to the Board of Directors of Grifols, S.A. from 2001 to 2015, when she was appointed Secretary non-member to the Board of Directors, a position she held until December 2025. Since 1 January 2026 she has once again held the position of Vice-Secretary non-member. Ms. Martín was a partner of the Spanish law firm Osborne Clarke until December 31, 2025, where she acted as the managing partner of the firm from July 1, 2017 until December 31, 2022. Prior to joining Osborne Clarke she worked in the Corporate and Tax Department of KPMG Peat Marwick from 1982 to 1986. Ms. Martín is a trustee and Chairperson of the Probitas Fundación Privada foundation. She is secretary and member of the board of directors of Compañía General de Inversiones, SICAV, S.A., and Gesiuris CAT Patrimonis, as well as Secretary, non-member, of the Board of Gesiuris Asset Management, S.G.I.I.C., S.A. Ms. Martín earned her law degree from the University of Barcelona.
Senior Management
We have continued to effect changes in our senior management aligned with our strategic plan of streamlining corporate functions, separating ownership from our senior management and enhancing other efficiencies across the organization. See Item 5 of this Part I “Operating and Financial Review and Prospects—A. Operating Results—Factors Affecting Our Financial Condition and Results of Operations—Operational Improvement Plan.”
In March 2025, Ms. Montse Ribas was appointed as our Chief Communications and Reputation Officer, replacing Ms. Maria Teresa Rioné Llano.
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Our senior management currently consists of the following persons:
Since
Chief Executive Officer
Rahul Srinivasan
Chief Financial Officer
Camille Alpi
Chief Human Resources and Talent Officer
Daniel Fleta Coit
Chief Industrial Services Officer
2022
Montse Ribas Lloveras
Chief Communications and Reputation Officer
Antonio Martinez Martinez
President, Diagnostic
Lluis Pons Gomez
Senior Vice President, Strategy
Ignacio Ramal Subira
Chief Internal Audit & Enterprise Risk Management
Jaime González Peralta
Chief Digital Information Officer
Jordi Balsells Valls
President, Plasma Procurement
Roland Wandeler
President, Biopharma
Enrique de la Torre
Chief Compliance Officer
2019
Oscar Calsamiglia Mendlewicz
General Counsel
Senior Management Biographies
The following are the biographies of our senior management who are not also directors:
Rahul Srinivasan has served as Grifols’ Chief Financial Officer since September 2024 and oversees the company’s overall financial function, including planning, treasury, tax, financial reporting, investor relations and sustainability.
Mr. Srinivasan brings over 25 years of financial services expertise in various senior leadership roles across KPMG, Credit Suisse and Bank of America. His extensive financial services background spans audit and assurance services, transaction services, corporate finance, mergers and acquisitions, and capital markets. Most recently he was the Head of EMEA Leveraged Finance and Capital Markets at Bank of America.
He is a distinguished Fellow of the Institute of Chartered Accountants in England and Wales (ICAEW) and has a bachelor’s degree in Business Mathematics and Statistics from The London School of Economics and Political Science. Additionally, he was awarded a fully sponsored Executive MBA from ENPC School of International Management in Paris, France.
Camille Alpi joined Grifols as Chief Human Resources & Talent Officer in February 2024, bringing with him two decades of international HR leadership experience across Europe, the United States, South America and Asia.
Before joining Grifols, he served as Vice President Human Resources for Danone Specialized Nutrition, the company’s healthcare division. In his different roles as an HR leader, he led HR strategies at local, regional, and global levels, with a strong focus on talent and organizational development, employee experience and engagement, as well as transformation and change management.
Mr. Alpi holds a Master’s degree in Business and Economics from Uppsala University in Sweden.
David Bell is the Chief Corporate Development Officer at Grifols, where he leads Corporate Affairs, Data Protection, Special projects and Compliance. Since joining Grifols in 2003 as General Counsel, Mr. Bell has been a member of the Executive Committee and the Company’s Management Boards.
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From 2016 to 2020, he served as Chief Innovation Officer, and in 2021, he was appointed Chief Corporate Development and Legal Officer, focusing on strategic partnerships and business expansion. Prior to his tenure at Grifols, Mr. Bell was Vice President and General Counsel, Corporate Secretary at Alpha Therapeutic Corporation and a partner at Knapp, Petersen & Clarke.
Mr. Bell earned his law degree from Southwestern University and holds a Bachelor of Science in Psychobiology from the University of California, Irvine. He also completed the Program of Instruction for Lawyers at Harvard Law School. For over a decade, he has served on the Global Board of Directors of the Plasma Protein Therapeutics Association (PPTA), acting as its Chairman from 2016 to 2019.
Daniel Fleta has served as Chief Industrial Services Officer at Grifols since January 2019. His career at Grifols spans over two decades, with several key leadership positions at Grifols Engineering, including General Manager.
He holds a degree in Industrial Engineering, specializing in Chemistry, from Universitat Ramon Llull in Barcelona, and completed executive programs at IESE Business School. His extensive background in industrial operations and engineering has contributed significantly to Grifols’ growth and innovation in the healthcare sector.
Ms. Ribas joined Grifols in March 2025 as the Chief Communications and Reputation Officer. Prior to joining Grifols, Ms. Ribas spent 30 years at fashion and fragrance company Puig, where she led corporate communication, public strategy and high-level institutional relations serving as Corporate Communications and Protocol Director. Ms. Ribas has a Business Administration degree and two Master’s degrees from ESADE (Business Management and Corporate Communication). Her extensive experience includes media relations, crisis communication, corporate transformation, and managing major events.
Antonio Martínez, PhD, is the President of our Diagnostic business unit, a role he has held since June 2022. Previously, he served as President of Scientific and R&D in the same unit. Dr. Martinez founded and served as Chief Executive Officer of Progenika Biopharma, S.A. for nearly 20 years before the company became a part of the Grifols Group. Earlier in his career, he worked at PharmaMar, a pharmaceutical company, and as a professor of Chemistry at Universidad de Navarra.
Dr. Martínez holds a doctorate in Molecular Genetics from the Universidad de Navarra and a master’s in Operations Management from IE Business School. He also earned a bachelor’s degree in Chemistry from Universidad de Murcia.
Mr. Pons joined Grifols in 2017. He currently serves as Senior Vice-President, Strategy. Previously, Mr. Pons served in Bain&Co. as a management consultant. Mr. Pons holds an MBA from Hong Kong UST and London Business School and received a degree in Industrial Engineering from the Universitat Politecnica de Catalunya in 2000.
Mr. Ramal joined Grifols in 2008. He currently serves as Chief Internal Audit & Enterprise Risk Manager. Previously, Mr. Ramal served as external auditor in Ernst & Young. Mr. Ramal received a degree in Economics and is a Certified Public Accountant in Spain.
Jordi Balsells joined Grifols as President of our Plasma Procurement business unit in October 2022. He brings a wealth of experience in strategic leadership and business development from his diverse career in global markets. Prior to joining the company, Mr. Balsells was Managing Director of Merchandising & Licensing at Football Club Barcelona.
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Before his tenure at FC Barcelona, he spent over a decade at Desigual, a leading fashion brand, where he held various senior leadership positions and was part of the executive team that drove the company’s business expansion in Asia and significantly enhanced its digital customer experience. During this time, he lived and worked in London and Hong Kong.
Mr. Balsells holds a degree in Economics and Business Administration from Universitat Pompeu Fabra (Barcelona), an Executive MBA from ESADE and has completed the Program for Management Development (PDG) at IESE Business School. He has also completed executive education programs at INSEAD and Harvard Business School.
Roland Wandeler, PhD, joined Grifols as President of the Biopharma business unit in January of 2024, bringing more than two decades of global biopharmaceutical experience in executive roles and strategic management consulting to the company.
Dr. Wandeler has a strong record of building and leading teams, setting strategy, and driving growth through commercial, operational and organizational excellence throughout his career spanning Europe and the United States. His prior roles include Chief Commercial Officer at MorphoSys and multiple executive positions during his 14-year career at Amgen, including Corporate Vice President and General Manager of Bone Health and Cardiology in the U.S., VP & General Manager of Germany and General Manager of Iberia.
A graduate of the Swiss Federal Institute of Technology (ETH) in Zurich, Dr. Wandeler holds a doctorate in technical sciences and a Master of Science in Chemical Engineering.
Jaime Gonzalez Peralta
Mr. González joined Grifols in 2024 as Chief Digital Information Officer. He has more than 25 years of experience designing value-added IT solutions for large, complex multinational organizations across Europe and the USA. Most recently, he served as Global Chief Information Officer at Radisson Hotel Group in Belgium.
Mr. González holds a master’s degree in Computer Sciences and Telecommunications, among other qualifications.
Mr. De la Torre joined Grifols in 2014 as Global Compliance Director. He has served as Chief Compliance Officer since 2019. Previously, Mr. De la Torre worked as quality, risk & compliance auditor for clients of different industries before joining Boehringer Ingelheim in 2001, where he held management positions in environmental protection, safety, computer systems validation and data protection. Since 2010, he has served as Compliance Officer for the Spanish affiliates. Mr. De la Torre received his degree in chemical engineering from Institut Químic de Sarrià in 1996. He also holds a master’s degree in risk management from Universitat Ramon Llull, and an Executive MBA degree from Esade Business School.
Oscar Calsamiglia is Grifols’ General Counsel, overseeing all global legal matters and ensuring that the company’s governance framework effectively supports its long-term strategy. He joined Grifols in September 2025 and has been a member of the Executive Committee since January 2026.
Prior to joining the company, Mr. Calsamiglia served as a partner at Osborne Clarke Spain, a leading international law firm, where he specialized in corporate development, shareholder management and complex commercial agreements. Over more than a decade in private practice, he advised Grifols on some of its most significant corporate transactions, gaining extensive experience in corporate and commercial law.
Mr. Calsamiglia holds a Law degree from Pompeu Fabra University and a Master’s in International Business Law from Queen Mary University of London. He is also a member of the Barcelona Bar Association.
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Family Relationships
Mr. Raimon Grifols Roura, our proprietary director, and Mr. Víctor Grifols Roura, a former director and Honorary Chairperson (non-member) of the Board, are brothers.
Mr. Raimon Grifols Roura is the uncle of Mr. Víctor Grifols Deu, both our proprietary directors and former Co-Chief Executive Officers.
Mr. Víctor Grifols Deu, our director and former Co-Chief Executive Officer, is the son of Mr. Víctor Grifols Roura, a former director and the Honorary Chairperson (non-member) of the Board.
Messrs. Víctor Grifols Roura and Raimon Grifols Roura are the grandchildren of Mr. José Antonio Grifols i Roig, our founder.
Mr. Raimon Grifols Roura, our director and former Co-Chief Executive Officer, and Mr. Victor Grifols Roura, a former director and Honorary Chairperson (non-member) of the Board, are uncles of Mr. Albert Grifols Coma-Cros, our proprietary director.
Mr. Víctor Grifols Deu and Mr. Albert Grifols Coma-Cros are cousins.
Arrangements Pursuant to Which Certain Directors or Senior Management Were Selected
We have no arrangements.
The compensation of our directors is determined pursuant to our director remuneration policy. Pursuant to Article 15 of the Regulations of the Internal Functioning of the Board of Directors of Grifols, S.A. (Reglamento de funcionamiento interno del consejo de administración, or the “Board Regulations”), the appointments and remuneration committee of the Board (Comisión de Nombramientos y Retribuciones, or the “Appointments and Remuneration Committee”) must, as a core responsibility, propose to the Board of Directors (for approval and further proposal to the shareholders) the remuneration policy applicable to our directors. Further, the Appointments and Remuneration Committee also proposes to the Board of Directors, for approval, the remuneration of our senior managers and employees performing top-level management duties under the direct supervision of the Board.
When determining the remuneration policy, the Appointments and Remuneration Committee considers the comparative market data, carrying out, to this end, an external competitive analysis of the remuneration package of all the Company’s employees, among them, the management team. This analysis is carried out to analyze the adequacy of the compensation levels and ensure that these are in line with market standards of other companies in the sector for equivalent levels of responsibility. Salary surveys carried out by independent consultants are usually used as a source of information for this analysis.
Following the recommendation of the Appointments and Remuneration Committee, our shareholders approved our current director remuneration policy at the general shareholders’ meeting held on June 5, 2025 (the “Director Remuneration Policy”). The main changes introduced by the new Directors’ Remuneration Policy include: (i) all references to the Executive Chairperson and related compensation are removed, as Mr. Thomas Glanzmann ceased to be the Executive Chairman in September 2024. Consequently, the only director with executive duties currently included in the Remuneration Policy is Mr. José Ignacio Abia Buenache, in his capacity as CEO; (ii) the fixed compensation for the Non-Executive Chairperson was introduced following a thorough comparative analysis to determine the most appropriate remuneration for such role; (iii) the compensation of the members of the Board in their capacity as such was updated to align it with comparable companies in the sector, reflecting also the significant increase in the workload and responsibilities assumed by the members of our Board and the maximum amount of the overall compensation was updated; and (iv) the metrics to determine the variable remuneration of the CEO for the 2025 fiscal year was updated.
The Director Remuneration Policy is effective from the date of its approval, June 5, 2025, and for the following three fiscal years (i.e. 2026, 2027 and 2028, inclusive). In accordance with applicable law, a new remuneration policy must be submitted for approval by our general shareholders’ meeting before the end of the last financial year of the policy then in place (which was 2025), and may be applicable from the moment of its approval.
Compensation of Members of the Board
Our Articles of Association generally set forth the processes for the determination of the compensation paid to the members of the Board. Article 20.bis of the Articles of Association provides that the directors’ remuneration shall be approved by the general shareholders’ meeting and shall apply for a maximum of three fiscal years. New directors’ remuneration policies must be approved by the general shareholders’ meeting prior to the last year of applicability of the previous policy, and any new policies approved may apply from the date of approval up to the three following years if so determined by the general shareholders’ meeting.
Pursuant to Article 26 of the Board Regulations, the Director Remuneration Policy (i) with respect to directors in their role as such, must necessarily determine the maximum amount of aggregate annual remuneration to be paid to all directors, as well as the criteria for its distribution taking into account the duties and responsibilities attributed to each of them and (ii) with respect to directors performing executive duties, must include the amount of annual fixed remuneration, the different parameters to set the variable components and the main terms and conditions of their contracts, including, in particular, duration, severance payments or compensations for the termination of the employment relationship, exclusivity, post-contractual non-competition, and retention or loyalty agreements. The Board then determines how much of the shareholder-approved aggregate compensation amount will be allocated to each director as compensation, taking into account a prior report of our Appointments and Remuneration Committee, in each case pursuant to the framework of the Articles of Association, the Director Remuneration Policy and the relevant agreements, as applicable.
Our directors are entitled to receive compensation in a fixed amount for serving as directors on our Board, pursuant to our Articles of Association and the Director Remuneration Policy. Director compensation for the performance of executive duties may consist of (i) a fixed amount, (ii) a variable amount based on financial and non-financial metrics, (iii) if applicable, compensations in certain cases of termination or dismissal, and (iv) may include the delivery of shares, or share options or amounts referenced to the value of the shares, subject to the requirements established by the legislation from time to time, in each case pursuant to the Articles of Association and the Director Remuneration Policy, as well as with the agreements approved in accordance with the provisions of the Spanish Companies Act.
The total compensation accrued by directors in the year ended December 31, 2025, in the aggregate, amounted to €6 million. This amount includes the remuneration of both executive and non-executive directors.
Non-executive Directors
Non-Executive Chairperson
The compensation of the Chairperson of the Board of Directors, as long as she/he does not have executive duties, will consist solely of a gross annual fixed amount of €550,000. This compensation is justified by the special dedication that the exercise of the duties inherent to the position of Chairperson entails. Such compensation was proposed by the Appointments and Remuneration Committee following a thorough comparative analysis to determine the most appropriate remuneration for a non-executive Chairperson.
Other Non-Executive Directors
Our independent directors, proprietary directors and those categorized as “Other External Directors” are non-executive directors (consejeros no ejecutivos). Our compensation philosophy, as set forth in Article 27 of the Board Regulations, provides that the remuneration of non-executive directors shall provide incentives for our directors to be dedicated and involved, while not creating an obstacle to their independence. To that end, Article 27 further establishes that the Board, following the advice of the Appointments and Remuneration Committee, shall take the necessary measures to ensure that non-executive directors’ remuneration adheres to the following guidelines: (a) their remuneration should be relative to their dedication, qualification and responsibility; and (b) they are excluded from any plans (x) consisting of the delivery of equity awards or options or other instruments linked to the value of our shares, (y) linked to our performance or (z) including retirement benefits. However, non-executive directors may be remunerated with our shares provided that they agree to hold such shares for the duration of the term as members of the Board.
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Pursuant to the Director Remuneration Policy, our shareholders set a fixed gross annual amount payable in cash of €125,000 payable per non-executive director, other than those non-executive directors that render paid professional services to us, if any. Any director that is a member of one of the Board Committees (Audit Committee, Appointments and Remuneration Committee, Sustainability, Communication and Reputation Committee, and Strategy Committee) receives an additional gross annual remuneration of €25,000 (thus, their total annual remuneration would amount to €150,000). Similarly, each committee chairperson receives an additional €25,000 (thus, their total annual remuneration would amount to €175,000). The lead independent director, if any, receives an additional remuneration amounting to €50,000 (thus, any lead independent director’s total annual remuneration would amount to €175,000). Under no circumstances the remuneration of a non-executive director may exceed €175,000 per year.
Our executive directors and any director who renders paid professional services to the Grifols Group do not receive any remuneration solely for their capacity as director. None of our directors received attendance fees for meetings of the Board or committees of the Board. Finally, pursuant to Article 20.bis of the Articles of Association, our directors are reimbursed for all expenses incurred in connection with their service as directors.
As of the date of this annual report, Ms. Anne-Catherine Berner, Dr. Enriqueta Felip Font, Ms. Susana González Rodríguez, Ms. Montserrat Muñoz Abellana, Mr. Iñigo Sánchez-Asiaín Mardones and Mr. Pascal Ravery are our independent directors in conformity with Exchange Act requirements and NASDAQ Listing Rules. Mr. Tomás Dagá serves as other external director (and not independent) and Mr. Raimon Grifols Roura, Mr. Víctor Grifols Deu, Mr. Albert Grifols Coma-Cros and Mr. Paul S. Herendeen serve as proprietary directors (and not independent) in conformity with Spanish corporate governance rules.
The following table details the individual compensation of each non-executive director for 2025:
Fixed Compensation
Committee Allowances
(in euros)
Thomas Glanzmann(1)
146,000
115,000
14,000
182,000
(2)
Victor Grifols Deu
129,000
49,000
164,000
24,000
139,000
39,000
154,000
359,000
21,000
380,000
1,655,000
266,000
1,974,000
The compensation of Mr. Thomas Glanzmann and Mrs. Anne-Catherine Berner as Non-Executive Chairpersons of the Board was paid pro rata to the number of months in 2025 during which they served in this role (from January to June 2025 for Mr. Thomas Glanzmann and from June to December 2025 for Mrs. Anne-Catherine Berner).
Reflects €53,000 in compensation accrued by Mr. Raimon Grifols Roura as a member of the Supervisory Board of Directors of Biotest, our subsidiary.
Executive Director
Currently our Chief Executive Officer is the only member of the Board who also performs executive functions for the Company.
Our Appointments and Remuneration Committee determined the compensation of the CEO by considering analogous roles in similar companies as indicated in the Director Remuneration Policy. The compensation for executive directors relating to their executive functions may consist of (i) a fixed amount, (ii) other benefits in kind, (iii) a variable cash amount based on financial and non-financial metrics including, among others, environmental, social and governance (“ESG”) objectives, (iv) if applicable, compensation in certain cases of termination or dismissal, and (v) the delivery of shares, or share options or amounts referenced to the value of the shares, subject to the requirements established by the legislation from time to time.
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The percentage of short-term variable remuneration for executive directors is set based on the fulfilment of certain objectives, which are established on an annual basis and approved by the Board, following the proposal from the Appointments and Remuneration Committee and the Sustainability, Communication and Reputation Committee, if applicable. These objectives are linked to different financial and non-financial metrics and parameters, all in accordance with the applicable remuneration policy.
For the year ended on December 31, 2025, the following financial and non-financial metrics were established in the Director Remuneration Policy. In relation to each of them, the Board approved the following objectives:
o
Target (with a weight of 20%): Achieve a certain level of operational performance calculated in constant currency;
Target (with a weight of 20%): Reach a certain level of consolidated free cash flow;
Target (with a weight of 20%): Reach a certain number of net sales after deducting discounts, returns and provisions for damaged or lost goods.
Target (with a weight of 10%): Establishment of the succession planning of the executive team; and
Target (with a weight of 5%): Achieve certain objectives related to the Company’s compliance performance.
Our Chief Executive Officer accrued €3.5 million in cash remuneration in 2025 (€2 million in fixed compensation, €1.3 million in variable compensation, which has been paid, and €0.2 million in remuneration in kind). This variable compensation amount was calculated based on the achievement of the above-mentioned specific performance objectives. The CEO’s variable remuneration was determined by applying a weighted payment coefficient of 65.59% to each of the objectives described above, resulting in a final variable compensation amount calculated on the basis of a total attainment percentage of 109.31%.
Former Executive Chairman
Mr. Thomas Glanzmann, our former Executive Chairman, accrued salary for the period from January 2025 through February 2025, up to the expiry of his service agreement, in an aggregate amount of €222,000, as well as €16,000 in non-cash benefits.
Other Members of Senior Management
In 2025, members of our senior management (excluding those who also served as members of the Board) accrued compensation amounting to €16 million, in the aggregate. This figure includes accruals for contingent or deferred compensation earned in respect of 2025 service. In 2024, members of our senior management (excluding those who also served as members of the Board) accrued compensation amounting to €14 million, in the aggregate. This figure includes accruals for contingent or deferred compensation earned in respect of 2024 service. In 2023, members of our senior management (excluding those who also served as members of the Board) accrued compensation amounting to €24 million in the aggregate. This figure includes accruals for contingent or deferred compensation earned in respect of 2023 service.
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The breakdown of the aggregate amount accrued and/or paid to our senior management (excluding those who also served as members of the Board) for discharging their duties in the years ended December 31, 2025, 2024 and 2023 is set forth in the table below.
Amount accrued and/or paid in the
year ended December 31,
Component
Salaries
9,828,275
7,930,417
14,567,449
Variable Compensation
5,720,309
5,745,949
9,131,372
Stock options or other securities
2,740,981
Other — e.g., life and health insurance
25,061
28,586
34,864
Other — e.g., pensions/savings
15,638
31,778
30,776
Executive Compensation Clawback Policy
On October 26, 2022, the SEC amended Rule 10D-1 and other rules under Section 10D of the Exchange Act to implement the incentive-based compensation recovery provision, referred to as the “clawback” provision, of the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Clawback Rules”). The Clawback Rules required national securities exchanges (such as NASDAQ) to adopt listing standards under which issuers must implement and enforce policies that require the clawback of incentive-based compensation received by any current or former executive officer during the three fiscal years immediately preceding the date of a required restatement of an issuer’s filed financial statements due to the issuer’s material noncompliance with any financial reporting requirement under the securities laws.
In June 2023, the SEC approved the proposed clawback listing standards issued by NASDAQ. On October 19, 2023, our Board of Directors approved our “Clawback Policy for the Recovery of Erroneously Awarded Compensation for the Senior Management,” to comply with the Clawback Rules. The policy is attached to this annual report as Exhibit 97.1.
Employment and Severance Arrangements
We have entered into employment contracts with four members of our senior management that entitle them to unilaterally rescind their employment contracts and receive termination benefits of two to five years’ salary in the event that we undergo a change of control. In addition to this, six members of our senior management are contractually entitled to termination benefits of one to two years’ salary under certain circumstances other than a change of control.
See Notes 27 and 31 to our audited consolidated financial statements included in this annual report for further details of the payments received by employees.
Equity and Other Incentive Programs
See “—E. Share Ownership” for a description of our equity-based compensation plans available to eligible employees, including members of our senior management.
Pension and Retirement Compensation Programs
Our directors and senior management employed by our U.S. subsidiaries participate in a tax-qualified 401(k) plan on the same terms as our other employees. The aggregate amount of employer contributions to the 401(k) plans for our directors and senior management during 2025 was €16 million. In 2025, neither we nor our subsidiaries set aside or accrued any other amounts to provide pension, retirement or similar benefits for our directors or senior management.
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Board of Directors
Pursuant to the Articles of Association, we are managed by a board of directors (the “Board”), which may be composed of not less than three and not more than 15 directors. Our current Board has 12 directors. Directors must be individuals. Under Spanish law, the Board is responsible for management, administration and representation in all matters concerning the business, subject to the provisions of the Articles of Association and the powers conferred at the general shareholders’ meeting.
Appointment and Dismissal
Pursuant to Spanish law and our Articles of Association, directors are elected by our shareholders to serve for a term of four years and may be reelected to serve for an unlimited number of terms, except in the case of independent directors, who pursuant to Spanish law and the regulations of our Board originally approved at the Board meeting held on April 5, 2006, as amended from time to time (the “Board Regulations”), shall not serve as such for more than 12 consecutive years. We do not provide for the reelection of directors at staggered intervals or cumulative voting for such directors or otherwise.
A director must be an individual. If a director ceases to hold office prior to the expiration of his or her term, the Board may fill the vacancy by appointing a new director to replace the outgoing director. Any director so appointed will hold office until the next general shareholders’ meeting when the appointment may be confirmed or revoked by our shareholders. If such appointment takes place between the time that a general shareholders’ meeting is called and the time the meeting takes place, then the director so appointed will hold office until the next general shareholders’ meeting, when this appointment is to be confirmed or revoked. Any such appointment will be only for the remainder of the term of the outgoing director, without prejudice to such director’s eventual election. A director may resign, or be removed, from office by a resolution of our general shareholders’ meeting at any time. A director who is also a shareholder may vote freely on any of our shareholders’ resolutions relating to the appointment and dismissal of directors (including the appointment or dismissal of that director).
In addition, pursuant to the Board Regulations, a director must tender a resignation to the Board and the Board may accept such resignation, in its discretion, under the following circumstances: (i) when the director ceases to hold the executive position to which such director’s appointment to the Board was related; (ii) when circumstances arise that might harm the Company’s name or reputation, related or not to their actions within the Company; (iii) when the director becomes unable to hold the office due to a legal cause of ineligibility or incompatibility; (iv) when any criminal charges are brought against or a formal inquiry is opened against him or her by a regulator; (v) when the director has been severely admonished by our Audit Committee for having breached his or her duties as director; (vi) when the director’s participation on the Board may jeopardize our interests or when the reasons for his or her appointment cease to exist; and (vii) in the case of a proprietary director, when the relevant shareholder ceases to hold its stake in us, or reduces its stake below the level that reasonably justified the appointment of such director. When a director leaves his/her position, whether by resignation or resolution of the general shareholders’ meeting before his/her tenure expires, he/she shall explain, in sufficient detail, the reasons behind this decision or, in the case of non-executive directors, his/her opinion of the reasons for the general shareholders’ meeting resolution, in a letter that must be sent to the members of the board via the chairperson or the secretary.
In addition, under Spanish corporate law, a holder of voting shares (or group of shareholders of voting shares acting together) may, subject to availability of seats on the Board, appoint a number of directors proportionate to that shareholder’s (or group of shareholders’) interest in our voting capital. If the voting capital stock represented by the shares held by such shareholder (or group of shareholders) is equal to or greater than the result of dividing our total voting capital stock by the number of directors, such shareholder (or group of shareholders) shall have the right to appoint a proportionate number of directors. For example, a shareholder holding 20 voting shares out of a total of 100 voting shares in a company with five directors will be entitled to appoint one director. Should this power be exercised, shares so pooled shall not participate in the voting for the other members of the Board. However, they may exercise their voting rights with respect to the removal of existing directors. Since such rights apply only to voting shares or Class B shares that have recovered their voting rights, our Class B shares and the Class B ADSs that represent them in the United States do not count towards the proportional representation right.
The Board must appoint a Chairperson of the Board from among its members. Mrs. Anne-Catherine Berner is the current non-Executive Chairperson, having replaced Mr. Glanzmann as the non-executive chairperson of our Board as of the general shareholders’ meeting in June 2025. The Board may also designate one or more Vice Chairperson, who shall be numbered consecutively, and who shall replace the Chairperson in the event of impossibility to act or absence. Mr. Raimon Grifols Roura is the current Vice Chairperson. The Board may appoint an Honorary Chairperson that is not required to be a member of the Board. The Honorary Chairperson shall have duties of honorary representation and will provide advice to the Board to the Chairperson and to the Vice Chairperson of the Board. Currently, Mr. Víctor Grifols Roura is the Honorary Chairperson, and a non-member of the Board.
The Board must also appoint a Secretary and may also designate one or more Vice-Secretaries. Neither the Secretary nor the Vice-Secretary is required to be a member of the Board; however, the Secretary or the Vice-Secretary will not be entitled to vote on matters before the Board unless he or she is a member of the Board. Ms. Laura de la Cruz Galán is the current Secretary non-member of the Board, while Ms. Núria Martín Barnés is the current Vice-Secretary, non-member, of the Board.
Meetings of the Board
Pursuant to the Articles of Association, a meeting of the Board may be called by the Chairperson whenever he/she considers such a meeting necessary or suitable. The Chairperson is also required to call a meeting at the request of one-third of the directors. Meetings of the Board are called using any means of notice at least ten days before the date of the meeting, unless exigent circumstances require a shorter term. Such notice of a meeting of the Board must state the place, date and time as well as the issues to be discussed. The Board is required by Spanish law to hold a meeting at least every three months. Our Articles of Association provide that a majority of the directors (half plus one of the directors present at a meeting) of the Board (represented in person or by proxy by another director on the Board; non-executive directors may only appoint another non-executive director to represent them) constitutes a quorum. Except as otherwise provided by law or specified in the Articles of Association, resolutions of the Board must be passed by an absolute majority of the directors present or represented at a meeting, with the Chairperson having the right to cast a deciding vote in the event of a tie.
Pursuant to the Articles of Association the Board may hold meetings by videoconference, conference call or by any other distance communication systems as long as said communications take place in real time and therefore, in one sole act, and both the identity of the participating or voting individual and the security of the electronic communications, are properly guaranteed.
Delegation of Powers
Pursuant to Spanish law and our Articles of Association, the Board may delegate its powers either to an executive committee (Comisión Ejecutiva) or to one or more chief executive officers. Spanish corporate law provides that resolutions appointing an executive committee, any chief executive officer or authorizing the permanent delegation of all, or part of, such board of directors’ powers, requires a two-thirds majority of the members of such board of directors and the registration of such resolution in the Spanish Commercial Registry (Registro Mercantil). The Board may also revoke such powers at any time. In addition, when a member of the Board is appointed chief executive officer or vested with executive functions, he/she will need to enter into an agreement with the Company, which shall be approved by a two-thirds majority of the Board. The director in question will have to refrain from participating in the deliberation and voting process of such agreement.
Under Spanish corporate law, a board of directors may also grant general or specific powers of attorney to any person whether or not that person is a director or a shareholder. General powers of attorney must be registered in the Commercial Registry. However, Spanish law provides that the following powers, among others, may not be delegated by the Board: (i) the formulation and submission for approval of the yearly financial statements at the general shareholders’ meeting; and (ii) those powers granted to the board of directors by a general shareholders’ meeting (unless otherwise provided in the relevant shareholders’ resolution).
Mr. José Ignacio (Nacho) Abia Buenache is the current Chief Executive Officer of the Company, with delegation of all powers legally delegable from the Board.
Expiration of Current Terms
The periods during which our directors and senior management have served in their offices, as well as the date of expiration of each director’s term, are shown in the tables under “—A. Directors and Senior Management” above.
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Committees of the Board
The Board has an Audit Committee, an Appointments and Remuneration Committee, a Sustainability, Communication and Reputation Committee and a Strategy Committee. The following is a brief description of such committees.
Audit Committee
The Board established an Audit Committee in compliance with Articles 24.bis and 24.ter of the Articles of Association and Article 14 of the Board Regulations.
The regulations applicable to the Audit Committee are set forth in the provisions referred to above, as well as the bylaws of the Audit Committee, which were approved by the Board and the Audit Committee on December 9, 2008, and most recently modified in April 2024 in order to adapt its content to the current recommendations of the Good Governance Code of Listed Companies. In connection with the Talecris Biotherapeutics acquisition, at a Board meeting held on May 24, 2011, the Articles of Association and Board Regulations were amended to conform to NASDAQ Listing Rules and to facilitate the listing of our Class B ADSs on NASDAQ. Furthermore, the bylaws of the Audit Committee were modified at a Committee meeting held on March 31, 2015, to adapt them to the requirements imposed by Law 31/2014. In 2017, article 24.ter of the Articles of Association and Article 14 of the Board Regulations concerning the composition and functions of the Audit Committee were amended in order to adequate their content to the latest amendments of the Spanish Companies Act introduced by the currently in force Spanish Audit Act. On May 3, 2024, the Board resolved to amend Article 14 of the Board Regulations to establish a maximum engagement period for auditors (including any extensions), ensuring that it is shorter than the maximum legal term set at any given time in order to safeguard the auditors’ independence.
Pursuant to our Spanish corporate governance requirements and our Articles of Association and the Board Regulations, the Audit Committee consists of a minimum of three directors and a maximum of five directors who are appointed by the Board based on such directors’ knowledge, competence and experience in accounting, audit and risk management matters (both financial and non-financial). All of the members of the Audit Committee must be non-executive directors, and the majority must be independent directors. As a group, the members of the Committee must have the pertinent technical knowledge in relation to the sector of activity of the Company. In addition, all members of the Audit Committee, including the chairperson, must meet the independence, experience and other requirements set forth in the Exchange Act and NASDAQ Listing Rules.
The responsibilities of the Audit Committee include:
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The Audit Committee currently consists of Mr. Iñigo Sánchez-Asiaín Mardones (who serves as chairperson), Ms. Montserrat Muñoz Abellana and Mr. Pascal Ravery. All are independent in conformity with Exchange Act requirements and NASDAQ Listing Rules, as well as in conformity with the Spanish Companies Act. Ms. Laura de la Cruz Galán serves as Secretary, non-member, of the Audit Committee.
Appointments and Remuneration Committee
The Board established an Appointments and Remuneration Committee in compliance with Article 24.bis and 24. quater of the Articles of Association and Article 15 of the Board Regulations.
The regulations applicable to the Appointments and Remuneration Committee are set forth in the provisions referred to above, as well as in the Regulations of the Appointments and Remuneration Committee, which were approved by the Board on May 3, 2024. Pursuant to Spanish corporate governance requirements, Article 15 of the Board Regulations and the Regulations of this Committee, the Appointments and Remuneration Committee is required to consist of between three and five members, all of which must be non-executive directors, which includes at least two independent directors. The Board, during its meeting held on 3 May 2024, resolved to approve the amendment of article 15 of the Board Regulations, the purpose was to introduce into the scope of responsibilities of the Committee the creation of a competency matrix and the leadership of the annual evaluation process of the Board and its Committees. Furthermore, it also includes the particular points to address in said evaluation.
The responsibilities of the Appointments and Remuneration Committee include:
146
Consistent with NASDAQ Listing Rules for foreign private issuers, our Appointments and Remuneration Committee currently consists of Ms. Montserrat Muñoz Abellana (who serves as chairperson) and Ms. Susana González Rodríguez (both independent directors in conformity with Exchange Act requirements and NASDAQ Listing Rules), as well as Mr. Tomás Dagá Gelabert (“other external” director), Mr. Víctor Grifols Deu and Mr. Paul Herendeen (both proprietary directors). Ms. Nuria Martín Barnés serves as Secretary, non-member, of the Appointments and Remuneration Committee.
Sustainability, Communication and Reputation Committee
In its meeting held on December 11, 2020, the Board resolved to amend certain articles of the Board Regulations, in order to adapt its content to certain recommendations of the reform of the Good Governance Code of Listed Companies published in June 2020 by the CNMV, and created a Sustainability, Communication and Reputation Committee.
The regulations applicable to the Sustainability, Communication and Reputation Committee are set forth in article 15 bis. of the Board Regulations, as well as in the Regulations of the Sustainability, Communication and Reputation Committee, which were approved by the Board on February 19, 2021 and amended in February 2023. On July 28, 2025, the Board of Directors approved the renaming of the then Sustainability Committee as the “Sustainability, Communication and Reputation Committee,” and the inclusion of new authorities within its scope of responsibilities. The Regulations of the Sustainability, Communication and Reputation Committee were amended accordingly. Pursuant to Article 15 bis of the Board Regulations and the Regulations of the Sustainability, Communication and Reputation Committee, the Sustainability, Communication and Reputation Committee is required to consist of between three and five members, all of which must be non-executive directors, the majority of them being independent.
The responsibilities of the Sustainability, Communication and Reputation Committee include:
147
The Sustainability, Communication and Reputation Committee currently consists of Ms. Susana González Rodríguez (who serves as chairperson), Mrs. Anne-Catherine Berner and Ms. Enriqueta Felip Font (all three being independent directors in conformity with Exchange Act requirements and NASDAQ Listing Rules), as well as Mr. Albert Grifols Coma-Cros and Mr. Raimon Grifols Roura (both proprietary directors). Ms. Núria Martín Barnés serves as Secretary, non-member, of the Sustainability, Communication and Reputation Committee.
The Sustainability Steering Committee is a multidisciplinary and international team created in 2021 coordinated by the Investor Relations and Sustainability Department, which reports to the Sustainability, Communication and Reputation Committee. Among its functions, the committee fosters ongoing dialogue to identify, establish, implement and confirm compliance with Grifols Strategic Plan objectives, and generates and coordinates the reporting of nonfinancial and corporate sustainability information.
Strategy Committee
On September 25, 2025, the Board created a Strategy Committee with the main purpose of assisting the Board of Directors and making proposals to it on strategic initiatives and developments.
The regulations applicable to the Strategy Committee are set forth in the Regulations of the Board of Directors, as well as in the Regulations of the Strategy Committee. Pursuant to the Regulations of the Board of Directors and the Regulations of the Strategy Committee, the Strategy Committee is required to consist of between three and five members appointed by the Board of Directors, all of whom must be non-executive directors, of which at least two must be independent directors.
The responsibilities of the Strategy Committee include:
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The Strategy Committee currently consists of Mrs. Anne-Catherine Berner (who serves as chairperson) and Mr. Íñigo Sánchez-Asiaín Mardones, who are independent directors in conformity with Exchange Act requirements and NASDAQ Listing Rules, Mr. Raimon Grifols Roura and Mr. Víctor Grifols Deu (both proprietary directors) and Mr. Tomás Dagá Gelabert (“other external” director). Ms. Núria Martín Barnés serves as Secretary, non-member, of the Strategy Committee.
The table below indicates the number of employees by department as of December 31, 2025, 2024 and 2023:
Department
Manufacturing
20,142
18,774
18,979
Research & development — technical area
1,403
1,514
1,255
Administration and others
1,789
1,673
1,686
General management
300
281
267
Marketing
184
155
Sales and distribution
1,375
1,396
1,395
25,247
23,822
23,737
The table below indicates the number of employees by geographic region as of December 31, 2025, 2024 and 2023:
Geographic Region
Spain
4,665
4,408
4,181
North America
14,310
13,771
14,076
6,272
5,643
5,480
We actively train our employees. The Grifols Academy opened in Spain during the second quarter of 2011. It is a meeting point for advanced training on all processes related to the preparation and production of plasma-derived medicines. The Grifols Academy acts as a center of technical, scientific and management training for the Grifols Group’s personnel, fostering a continued exchange among experts and external bodies, such as professional healthcare associations, hospitals, schools and universities. Through the Grifols Academy, we offer to our employees technical training and professional development opportunities, including an educational expenses reimbursement program, a number of long-term leadership development initiatives and onboarding processes conducted with virtual reality technology. In the last three years, an annual average of more than 9,200 of our employees participated in the Grifols Academy’s professional development and plasmapherisis training programs.
We have offered an internal, global online learning platform since 2024. In 2025, it was enhanced with new training initiatives and clearer communication, including the launch of a new Grifols Academy website on the corporate intranet and the regular distribution of newsletters.
The Grifols Academy of Plasmapheresis includes general and specialized programs on plasma science to accelerate the professional and educational development opportunities of our U.S.-based employees, helping the company reinforce its unique value proposition.
We promote social dialogue founded on freedom of association and the right to collective bargaining, taking into account the unique cultural, historical, economic and political frameworks in its countries of operation. In addition to cultivating open lines of communication, we adapt our social dialogue to each country’s specific context. These efforts strengthen our corporate culture and ensure employee needs are met.
Effective communication with workers’ legal representation is essential for addressing the transversal issues that require collective bargaining across the company’s various workplaces. The Spanish labor-relations system defines two types of company representation: trade union representation and unitary or elective representation. We hold regular and extraordinary staff-related meetings with these representatives, who form part of trade union sections, work councils and employee delegations. Our Spanish employees are mainly represented by three labor unions, the Workers’ Commissions (Comisiones Obreras - CCOO), the Workers General Union (Unión General de Trabajadores - UGT) and the General Labor Confederation (Confederación General del Trabajo - CGT).
In France, Germany and other countries, we regularly meet with workers’ legal representation. In Italy, we discuss decisions that could impact collective working conditions with trade union organizations. We fully support the fundamental right of association and collective bargaining in alignment with the Universal Declaration of Human Rights. In Spain, Germany, Italy, France, and Brazil, 100% of our employees are covered by collective bargaining agreements. Together, they represent 26.4% of the total workforce. In the United States, collective bargaining does not occur at the industry level; agreements are therefore negotiated within each company.
We subscribe to an insurance policy that covers death or permanent disability of employees caused by work accidents. All of our employees are covered under this policy. We implemented a defined contribution pension plan for all our Spanish entities beginning on January 1, 2002, which excludes top management and which requires us to make matching payments to these employees. Our contribution to this pension plan was €1 million in each of the years ended December 31, 2025, 2024 and 2023, respectively. We also sponsor a savings plan for the benefit of U.S. employees, which qualifies as a defined contribution plan under Section 401(a) of the Internal Revenue Code of 1986, as amended. We make fully vested matching contributions to the savings plan, which totaled $36 million in the year ended December 31, 2025, compared to $34 million and $33 million for the years ended December 31, 2024 and 2023 respectively. For certain employees in Germany, we have a defined benefit pension plan, as required by statutory law. The pension cost relating to this plan is not material.
For information on the direct, indirect and represented holdings of our current directors and executive officers with respect to our Class A shares as of December 31, 2025 see Item 7 of this Part I, “Major Shareholders and Related Party Transactions—A. Major Shareholders.”
In 2023, our Board of Directors made modifications to our Director Remunerations Policy, including the discontinuation of this partial payment of variable compensation in RSUs. Instead, our Board created two new variable compensation plans, which are described below. For more details regarding our Director Remunerations Policy, see “—B. Compensation.” For more information regarding our variable compensation plans, see Note 27 to our audited consolidated financial statements included in this annual report.
In 2024, our Board of Directors made modifications to our Director Remunerations Policy, in order to adapt such policy to the current circumstances of the Board of Directors. For more details regarding our Director Remunerations Policy, see “—B. Compensation.” For more information regarding our variable compensation plans, see Note 27 to our audited consolidated financial statements included in this annual report.
In 2025, our Board of Directors made modifications to our Director Remunerations Policy, in order to approve a new remuneration policy before the end of the 2025 fiscal year, applicable from the date of approval and for the following three fiscal years (i.e. 2026, 2027, and 2028, inclusive). For more details regarding our Director Remunerations Policy, see “—B. Compensation.” For more information regarding our variable compensation plans, see Note 27 to our audited consolidated financial statements included in this annual report.
Equity-settled share-based payment plan
In 2023, we approved a four-year long-term incentive plan for certain executive directors, members of the senior management of Grifols, S.A. and our subsidiaries. Under this plan, these individuals have the right to receive a certain number of options representing the right to acquire certain Class A shares for an exercise price of €8.96 per share. Of the options granted, 40% will vest on the second anniversary of the plan and the remaining 60% will vest upon the fourth anniversary of the plan, in each case subject to certain vesting conditions. A maximum of 4 million stock options, representing the right to acquire 4 million Class A Shares, will be granted under the equity-settled share-based payment plan. The recognized amount in equity as of December 31, 2025 was equal to €6 million (€6 million as of December 31, 2024).
Cash-settled share-based payment plan
In May 2023, our Board of Directors approved a four-year long-term incentive plan for certain members of our management team. The plan is based on the award of restricted stock units (RSUs), of which 50% will vest upon the second anniversary of the plan and the remaining 50% will vest at the end of the fourth year of the plan. The RSUs granted under this plan will be settled in cash for the amount equivalent to the average price of the Class A Shares during the five business days preceding the settlement date. In May 2025, 50% of the RSUs granted were settled, amounting to €2 million. As of December 31, 2025, the total accumulated amount is €2 million as long-term in the heading “Provisions” (€3 million as of December 31, 2024, of which €2 million were short-term in the heading “Trade creditors and other accounts payable” and €1 million were long-term in the heading “Provisions”). The amount recognized in the consolidated statement of profit and loss as of December 31, 2025 amounts to €1 million (€1 million in 2024).
Fidelity programs addressed to management
In 2024, we entered into agreements with certain executives establishing a long-term share-based or cash-based incentive as part of our remuneration system. In the case of transfer of shares, we will grant these incentives in equal terms on the anniversary date or at the end of the relevant period, provided that each such beneficiary must have been continuously employed by Grifols until the settlement date. We recognized an amount of €4 million in equity as of December 31, 2025.
New Stock Incentive Plan
In 2025, we approved the 2025 Stock Incentive Plan — a long-term variable compensation plan — to be offered on a discretionary basis to members of the senior management team and other key employees of the Group. The purpose of the plan is to align the interests of the beneficiaries with those of the shareholders and to support the long-term success of the company by promoting sustainable value creation, retaining key talent, and aligning with market standards.
The potential beneficiary group includes approximately 47 individuals, of whom 11 are senior executives. Neither the CEO nor the CFO will be beneficiaries of the Plan. The plan has a three-year vesting period, which began on April 29, 2025, and will be settled in Class A shares within a reasonable period after the completion of such vesting period. The maximum number of shares to be delivered is 1,032,671, subject to the achievement of specific targets. We recognized an amount of €3 million in equity as of December 31, 2025.
There was no erroneously awarded compensation paid to our executive officers in 2025.
The following table sets forth certain information, including information regarding beneficial ownership of our Class A (voting) shares as of the date of this annual report, for (i) our major shareholders, including, in accordance with applicable Spanish regulations, each person or entity that is known to us to be the beneficial owner of more than 3% of our Class A shares or 1% of our Class A shares in the event of a person or entity domiciled in a tax haven, (ii) each of our directors and (iii) each member of our senior management.
Since our Class A shares are represented through book entries, their exact ownership structure cannot be known, except through the information that the shareholders provide voluntarily or in compliance with applicable regulations, and information provided by the Sociedad de Gestión de los Sistemas de Registro, Compensación y Liquidación de Valores, S.A., or Iberclear, on which the shares are settled and cleared, and its participant entities (entidades participantes).
Beneficial ownership is determined in accordance with applicable Spanish regulations.
Number of
Percentage of
Voting
Name of Beneficial Owner
Shares
rights
Deria S.L.(1)
64,787,366
15.204
Scranton Enterprises B.V.(2)
35,812,622
8.404
Ponder Trade, S.L.
30,209,093
7.089
Blackrock, Inc.(3)
20,052,272
4.706
Flat Footed LLC (4)
13,335,000
3.129
Mason Capital Master Fund L.P. (5)
13,525,737
3.174
Armistice Capital Master Fund LTD.
4,534,850
1.064
The Goldman Sachs Group, Inc. (6)
15,340,711
3.600
Bank of America Corporation(7)
13,937,916
3.272
Fidelity International Limited(8)
4,509,430
1.058
117,807
*
Tomás Dagá Gelabert (9)
1,039,584
Víctor Grifols Deu(10)
153,221
57,118
66,000
77,121
2.329
20,000
16,759
75,242
7,224
Less than 1%.
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To our knowledge, we are not controlled, directly or indirectly, by any other corporation, government or any other natural or legal person. We do not know of any arrangements which would result in a change in our control.
As of the date of this annual report on Form 20-F, based on public information provided to us by our listing agents, we estimate that 64.3% of our shares were held by holders of record in the United States. Since shares may be held by nominees, the number of shareholders of record may not be representative of the number of beneficial owners.
Significant Changes in Ownership
Other than as described below, no significant changes occurred from January 1, 2023 until the date of this filing, as such transfers of shares were reported to the CNMV:
Voting Rights
Each of our Class A shares is entitled to one vote, except that the voting rights of Class A shares held in treasury by us or by any of our direct subsidiaries are suspended. Class A shares held by our major shareholders, directors or senior management do not entitle such shareholders to different voting rights.
Holders of our Class B shares generally do not have voting rights, except with respect to certain extraordinary matters that require approval by a majority of our outstanding Class B shares. However, each of our Class B shares entitles its holder to receive a minimum annual preferred dividend out of the distributable profits at the end of each fiscal year the share is outstanding equal to €0.01 per Class B share. In any given fiscal year, we will pay a preferred dividend to the holders of our Class B shares before any dividend out of the distributable profits for such fiscal year is paid to the holders of our Class A shares.
See in Item 10 of this Part I, “Additional Information—B. Memorandum and Articles of Association—Shareholder Rights—Class B Shares—Separate Vote at General Shareholder Meetings on Extraordinary Matters” and “Additional Information — B. Memorandum and Articles of Association — Shareholder Rights” for further details regarding our Class A shares and Class B shares.
From time to time we have entered into transactions with related parties at an arm’s length basis, including with entities involving certain members of our Board of Directors or senior management. We have policies in place to ensure that these transactions are conducted transparently and in accordance with applicable regulations and good corporate governance practices.
Related Party Transactions Policy and Conflicts of Interest Policy
On May 3, 2024, we adopted our Related Party Transactions Policy (“RPT Policy”) and, on October 22, 2024 we adopted our Conflicts of Interest Policy.
Our RPT Policy establishes strict processes for the analysis, approval and publication of transactions with related parties, all of which in accordance with the applicable law. Our Conflicts of Interest Policy complements the RPT Policy by requiring personnel to promptly disclose any real, potential, or perceived conflicts to the internal audit department or the Ombudsperson, with annual declarations mandated for ongoing compliance. The full content of these policies is available in our website. In addition, for further details regarding our related party transactions, see Note 31 to our audited consolidated financial statements included in this annual report. The following is a description of material related party transactions we have entered into since January 1, 2023.
Transactions involving Haema GmbH (formerly known as Haema AG), BPC Plasma Inc. (formerly known as Biotest Pharmaceuticals Corporation) and Scranton Enterprises B.V. and their respective subsidiaries
Sale of the entities to Scranton Plasma B.V., Vendor Loan to Scranton Plasma B.V. and Call Option Agreement
On December 28, 2018, we sold our 100% stake in each of Haema GmbH and BPC Plasma Inc. to Scranton Plasma B.V., a subsidiary of Scranton Enterprises B.V., one of our major shareholders and a related party, for a total of $538 million. Scranton Plasma B.V. financed the purchase through a loan in the principal amount of $360 million (the “Acquisition Financing”). The lender of the transaction required GWWO to extend a vendor loan to Scranton Plasma B.V. with a maximum amount of $150 million. The initial principal amount was equivalent to $95 million, with a maturity date of December 28, 2025 (which was extended to December 28, 2026 (and may be further extended to June 28, 2027 subject to GWWO’s consent) pursuant to an amendment agreement dated December 26, 2025), and an interest rate of EURIBOR plus 200 basis points. In 2023, GWWO loaned an additional €15 million to Scranton Plasma B.V. under the same terms and conditions of the vendor loan. As of the date of this annual report on Form 20-F, €124 million was outstanding on the vendor loan, while the largest amount of this loan outstanding since January 1, 2023 was €133 million as of February 28, 2025. See Note 11(a) to the audited consolidated financial statements included in this annual report.
Also on December 28, 2018, we entered into a call option agreement with Scranton Plasma B.V. whereby we may repurchase the shares of Haema GmbH and BPC Plasma Inc. at any time. The exercise price of the option as set forth in the agreement would be equal to the greater of: (i) the same price for which the shares were sold to Scranton Plasma B.V., plus the expenses related to the transaction and the increase in net working capital from the time of the sale (December 28, 2018) to the exercise of the option, and (ii) the amount necessary to repay the Loan Agreement (as defined below), which refinanced the Acquisition Financing, i.e. €425 million plus accrued interest and any other amounts necessary to cancel such debt.
Although we currently do not hold any equity interests in either Haema GmbH or BPC Plasma Inc., we retain control over such entities due to, among other factors, (1) the call option agreement to reacquire their shares and the financial capability to exercise such call option, (2) potential voting rights derived from the call option, (3) the fact that we acquire all of the plasma collected in the plasma collection centers owned by Haema GmbH and BPC Plasma Inc. under the Plasma Supply Agreement described below and (4) the ability to manage such entities under management agreements. As a result of these factors, pursuant to IFRS 10 we fully consolidate such entities as Grifols subsidiaries in our financial statements. Considering the uncertainties underlying the valuation of the option as it deals with non-observable variables, and the value of the same not being significant, said value has not been recognized as of December 31 2025 and 2024. For more details, see Notes 17 and 29 to the audited consolidated financial statements included in this annual report.
In July 2024, Scranton entered into a loan agreement with funds controlled or managed by Oaktree (the “Loan Agreement”) to refinance the Acquisition Finance. This new financing benefits from the following guarantees and security interest: (i) guarantees from BPC Plasma Inc. and Haema GmbH, (ii) pledges over the shares of Haema GmbH and BPC Plasma Inc., and (iii) pledges over the assets of BPC Plasma Inc. and Haema GmbH.
In the event of a default by Scranton under this new debt, we will be entitled to exercise the repurchase option for both companies within 90 days after receiving notification of the default. If we fail to exercise this option within that timeframe, we will lose the right to repurchase the shares of Haema GmbH and BPC Plasma Inc. As of December 31, 2025, no defaults have been reported under the Loan Agreement.
Plasma Supply Agreement and Advance Payments from GWWO to Scranton Plasma B.V.
On December 28, 2018, our subsidiary GWWO, BPC Plasma Inc. (formerly known as Biotest Pharmaceuticals Corporation), Haema GmbH and Grifols, S.A. entered into the Plasma Supply Agreement, whereby GWWO agreed to acquire all of the plasma collected from approximately 60 plasma collection centers owned by BPC Plasma Inc. and Haema GmbH. Grifols, S.A. guarantees all GWWO obligations under the Plasma Supply Agreement, which, on January 1, 2019, was extended for a 30-year period.
The price GWWO pays for the plasma acquired under the Plasma Supply Agreement is established based on the full cost of production, plus a fixed margin, and there is exclusivity of sale. Subject to certain conditions and procedures, the agreement also grants to BPC Plasma Inc. and Haema GmbH the right to receive payments from GWWO in advance for plasma to be delivered in the future. As of the date of this annual report, GWWO did not have any advance payments balances for future deliveries of plasma under the Plasma Supply Agreement. During 2025, the highest balance of advance payments amounted to €11 million.
In November 2025, a total amount of €11 million relating to costs incurred during the period between 2019 and 2025 by Scranton Plasma, B.V. and other entities within its group in connection with the Plasma Supply Agreement was recognized.
Cash-Pooling Financing Agreement between BPC Plasma Inc., Haema GmbH and Scranton Plasma B.V.
In February 2019, Haema GmbH and BPC Plasma Inc. entered into a Cash-Pooling Financing Agreement with Scranton Plasma B.V. with a maturity date in 2027. Under this agreement, Haema GmbH and BPC Plasma Inc. transfer funds from time to time to their parent company, Scranton Plasma B.V. which advances may be set off by Scranton Plasma B.V. against upstream dividends distributed from time to time by Haema GmbH and BPC Plasma Inc. As of December 31, 2025 and 2024, the balances of the advances under this cash-pooling agreement were €11 million and €82 million, respectively. Despite their maturity date being 2027, these have been maintained in the short term as their recovery is expected through the collection of dividends in the coming year. In 2025, 2024 and 2023, BPC Plasma Inc. distributed dividends without cash outflow to Scranton Plasma B.V. in the amounts of €26 million, €40 million and €266 million, respectively (the 2023 amount corresponded to the BPC Plasma Inc. results of the four immediately preceding fiscal years). During 2025, the highest balance under this cash-pooling agreement amounted to €111 million. Additionally, in 2025 Haema GmbH distributed to Scranton Plasma B.V a dividend without cash outflow that amounted €87 million.
Acquisition of Haema Plasma Kft.
On October 31, 2024, through our subsidiary GWWO, we acquired 100% of the capital of Haema Plasma Kft. from Scranton Plasma, B.V. (one of our major shareholders) for an amount of €35 million. This acquisition was supported by a fairness opinion issued by an independent expert and resulted in a reduction of the corresponding non-controlling interest in its entity.
In 2021, we entered into a call option agreement with Scranton Plasma B.V. whereby we had the right to acquire the shares of Haema Plasma Kft. Also in 2021, our subsidiary GWWO entered into a cash pooling financing agreement with Haema Plasma Kft. under which GWWO advanced resources from time to time to a centralized treasury mechanism for purposes of providing Haema Plasma Kft. with cash availability. Since 2022, financial information on Haema Plasma Kft. had been part of our consolidated financial statements and this transaction had been reported under our consolidated balance sheets. Given that we already exercised control over Haema Plasma Kft. prior to the acquisition, the transaction had no impact on our consolidated statement of profit and loss for the 2024 or 2025.
See Notes 2(b) and 31 to our consolidated financial statements as of and for the year ended December 31, 2025, included to this annual report.
Promissory Notes issued by our subsidiary Instituto Grifols S.A.
Instituto Grifols S.A. has been issuing bearer form promissory notes on an annual basis since 1987 to provide additional working capital and liquidity to the Grifols Group. The promissory notes are non-negotiable securities and may not be transferred to third parties (except by Instituto Grifols, S.A. itself for subsequent redemption) until the date of the notes’ redemption. The issuance of the promissory notes is not considered a public offering for the subscription of securities under Spanish law and does not require verification by the CNMV. As of December 31, 2025, 2024, and 2023, the outstanding balances of the promissory notes owned by our related parties was €8 million, €9 million and €18 million, respectively. These amounts were also the highest outstanding balances throughout 2025, 2024 and 2023, as applicable.
These bearer promissory notes have one year maturity and a nominal value of €3,000 each. Instituto Grifols, S.A. redeems all outstanding promissory notes at their maturity date of May 5, regardless of the date of acquisition of such notes. The interest rate for the promissory notes is set based on the weighted average cost of the Grifols Group’s debt. The notes maturing on May 4, 2025, accrue interest at an annual rate of 5%. The notes maturing on May 5, 2026, accrue interest at an annual rate of 4.25%. See Notes 19 and 31 to our consolidated audited financial statements included in this annual report.
Transactions with Centurión Real Estate S.A.U.
We have entered into a number of lease agreements with Centurión Real Estate S.A.U. whereby we pay for the rights-of-use of certain real estate properties located at Sant Cugat del Vallès, Barcelona, Spain, which we use as office buildings, including for our Spanish headquarters. The sole shareholder of Centurión Real Estate S.A.U. is Scranton Enterprises B.V., one of our major shareholders. These lease agreements were entered into at an arm’s-length basis. In each of the years ended December 31, 2025, 2024 and 2023, we paid to Centurión Real Estate S.A.U. the amount of €7 million. These lease agreements will expire on March 1, 2045.
License Agreement with Marca Grifols, S.L.
We entered into a license agreement with Marca Grifols, S.L. on January 26, 1993, that grants us the exclusive rights to use the “Grifols” trademark for 99 years. The license agreement provides that we must pay an annual royalty fee for the license, which is based on inflation and our net sales. The latest update of the agreement sets commission at 0.1% of Grifols’ consolidated sales. The fees for this license were €8 million, €8 million and €7 million in 2025, 2024 and 2023, respectively. On December 23, 2024, Marca Grifols became a related party to Grifols, S.A. after Ralledor Holding Spain, S.L., a significant shareholder of Grifols, S.A., acquired a 33% stake in Marca Grifols, S.L. Following the merger by absorption of Ralledor Holding Spain, S.L. into Deria, S.L. in 2025, Deria, S.L. (a significant shareholder of the Company represented at our Board by Mr. Raimon Grifols Roura and Mr. Víctor Grifols Deu) currently holds such 33% stake in Marca Grifols, S.L.
Advertising Agreement with Club Joventut Badalona, S.A.D.
On July 29, 2025, we entered into a sponsorship agreement with Club Joventut Badalona, S.A.D., an entity in which Scranton Enterprises B.V. (one of our major shareholders) is the majority shareholder. Pursuant to this agreement, we pay an annual fee to the club in exchange for exposure of our brand. We paid the amounts of €0.3 million , €0.3 million and €0.3 million in each of the years ended December 31, 2025, 2024 and 2023 in relation to this agreement and the prior advertising agreement entered into the parties on May 25, 2021.
Transactions with Endo Operations Limited
In 2025, Grifols, through our subsidiary, Laboratorios Grifols, S.A., generated income of €1 million from a series of Technology Transfer, Manufacturing and Supply Agreements entered into with companies of the Endo group. Mr. Paul S. Herendeen, who serves on our board of directors, held the position of director of the Endo group until July 31, 2025.
Charitable Contributions
In 2025, we contributed to three charitable foundations, the Víctor Grifols i Lucas Foundation, the J.A. Grifols Foundation and the Probitas Private Foundation, which were formed by us, and certain of our current officers serve as patrons of the Probitas Private Foundation.
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The Víctor Grifols i Lucas Foundation provides grants to further the study of bioethics. It was created in 1998 with the mission of promoting bioethics through dialogue between specialists in a range of areas. The Víctor Grifols i Lucas Foundation seeks to foster ethical attitudes in organizations, companies and individuals active in the field of human health, offering a discussion platform that provides a forum for the exchange of different perspectives. Mr. Víctor Grifols i Lucas is our former Chief Executive Officer and is the father of both Mr. Raimon Grifols Roura, our Vice chairperson proprietary director, and Mr. Victor Grifols Roura, our Honorary Chairperson (non-member) of the Board. We contributed €0.5 million, €0.5 million and €0.4 million to the Víctor Grifols i Lucas Foundation in the years ended December 31, 2025, 2024 and 2023, respectively.
The J.A. Grifols Foundation provides support intended for civic, social, environmental or educational programs that address the needs of the communities where our plasma collection centers are located as a means to strengthen community bonds. It was established in 2008 with the mission of contributing to the health and well-being of plasma donors and the communities where they live. In the years ended December 31, 2025, 2024 and 2023, we contributed €0.5 million, €0.5 million and €0.4 million, respectively, to the J.A. Grifols Foundation.
The Probitas Private Foundation provides medical and sanitary assistance to international communities that lack medical and sanitary resources or that have an urgent and essential need for such services due to catastrophes. The Probitas Private Foundation was founded by us in 2008. Mr. Tomás Dagá Gelabert, one of our directors, was a patron of the Probitas Private Foundation until May 27, 2021. We contributed €5 million, €3 million and €1 million to the Probitas Private Foundation in the years ended 2025, 2024 and 2023, respectively.
Loans
Except as otherwise described above in this section, we have not extended any advances or loans to members of the Board or key management personnel nor have we assumed any guarantee commitments on their behalf. We also have not assumed any pension or life insurance obligations on behalf of former or current members of the Board or key management personnel.
Financial Statements
See our audited consolidated financial statements and the related notes starting on page F-1 of this annual report on Form 20-F.
Legal Proceedings
We are involved in various legal proceedings in the ordinary course of our business. In the event of adverse outcomes of these proceedings, we believe that resulting liabilities will either be covered by insurance or not have a material adverse effect on our financial condition or results of operations.
OFAC Request for Interpretative Guidance
Our subsidiary Biotest entered into product-supply agreements with five different Iranian entities, whereby the Iranian entities send plasma collected in Iran to Biotest for processing. Biotest then uses the plasma to manufacture pharmaceutical products for the Iranian entities, including IG products, albumin, Factor VIII and Factor IX. These product-supply agreements were entered into by Biotest prior to our acquisition of the company in 2022. See Item 5 of this Part I, “Operating and Financial Review and Prospects—A. Operating Results—Factors Affecting our Financial Condition and Results of Operations—Recent Acquisitions—Biotest Shares and Public Delisting Purchase Offer.”
On February 21, 2023, Grifols filed a request with the Licensing Division of the U.S. Office of Foreign Assets Control (“OFAC”) for interpretative guidance or, in the alternative, for license authorization, under the Iranian Transactions and Sanctions Regulations (“ITSR”), which restrict commercial interaction with Iran and its governmental entities and provide for sanctions in the case of failure to comply. In its filing, Grifols asserts that the ITSR should not apply in this case, but that if OFAC determines otherwise, that OFAC should authorize the issuance of a license permitting Biotest’s current activity involving Iran on humanitarian grounds. As of the date of this annual report on Form 20-F, we have not received a response from the OFAC’s Licensing Division.
We cannot assure you that OFAC will agree with our assertion that the ITSR should not apply or that it will issue the requested license. In such instance, we would have to terminate Biotest’s activities in Iran and may be subject to penalties. The termination of Biotest’s activities in Iran would not have a material adverse effect on our operations or financial condition.
Antitrust Approval of Biotest Pharmaceuticals Corporation Acquisition
In August 2018, the FTC issued a consent order which allowed the acquisition of 24 donor centers and required the divestiture of three centers to Kedrion. The consent order requires annual reports to be made to the FTC for a period of 10 years. We have delivered each annual compliance report since we completed the acquisition and there has been no further action by the FTC.
CFIUS Approval on certain transactions
In September 2019, as a consequence of the share exchange agreement we entered with Shanghai RAAS, Grifols and the Committee on Foreign Investments in the United States (“CFIUS”) entered into a National Security Agreement to ensure the protection of certain data obtained as required from donors of human source plasma collected in the United States and maintained in donor management systems (“DMS”), and pursuant to this agreement, we are obligated to make bi-annual compliance reports to CFIUS. Grifols has timely filed all such reports.
Executive Committee of the CNMV.
On September 25, 2024, the Executive Committee of the CNMV initiated an administrative sanctioning procedure in connection with the conclusions reached by the CNMV on March 21, 2024, in connection with the investigation conducted by the CNMV following the short seller reports published in 2024. The sanctioning procedure is for alleged potential infringements related to the submission of regulated financial information for the fiscal years ended December 2021, 2022 and 2023 and the six-month period ended June 30, 2023, as well as to certain alternative performance measures (“APMs”) included in our management reports for the same periods.
Due to the amounts involved, we do not consider this procedure material, as it will not have any impact on our financial and operating results. We formally submitted our defense against the sanction on November 7, 2024. On May 16, 2025, we requested the CNMV to conclude the administrative procedure and, on June 25, 2025, the CNMV issued a ruling imposing fines totaling €1,360,000 on Grifols and certain members of our directors. This ruling initiated a two-month period to commence the contentious-administrative procedure before the Spanish National High Court. We formally filed an appeal with the court on September 24, 2025 and such appeal was admitted for processing by decree dated October 7, 2025. As of the date of this annual report on Form 20-F, the National Court has not yet received the administrative file from the CNMV, and therefore Grifols has not been summoned to file the statement of claim. See Note 29 to our consolidated financial statements included in this annual report on Form 20-F.
See Item 5 of this part I, “Operating and Financial Review And Prospects—Factors Affecting Our Financial Condition and Results of Operations—Short Seller Reports” and “Operating and Financial Review And Prospects—Factors Affecting Our Financial Condition and Results of Operations—CNMV’s Investigation Conclusions and Administrative Sanction Procedure.”
Dividend Policy
Class A Shares
Our dividend policy is to pay out approximately 40% of our net consolidated profits. However, the New Credit Facilities and some other documents governing our financial indebtedness contain limitations on our ability to pay cash dividends in the ordinary course of business in accordance with our dividend policy depending on our debt levels and the availability of certain restricted payments baskets. For a further discussion of the terms of the New Credit Facilities and our other financing arrangements, see Item 5 of this Part I, “Operating and Financial Review and Prospects—B. Liquidity and Capital Resources—Sources of Credit.”
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The declaration and payment of dividends is reviewed annually by the Board based upon a review of our balance sheet and cash flow, the ratio of current assets to current liabilities, our expected capital and liquidity requirements, the provisions of our governing documents and the provisions in our financing arrangements governing cash dividends. The payment of future dividend will be determined by the Board, based upon the factors described above and other factors that it deems relevant at the time that declaration of a dividend is considered. There can be no assurance as to whether or in what amounts any future dividend might be paid.
In addition, the availability of the reserves for distribution is subject to limitations under Spanish law. The distributable reserves of us and our Spanish subsidiaries are limited by the amount of mandatory reserves, which include, for us and each of our Spanish subsidiaries, the legal reserves and the amount of capitalized research and developments pending to be amortized by us and each of our Spanish subsidiaries. This limitation on distributable reserves due to capitalized research and developments expenditure amounted, on a consolidated basis, to €24 million at December 31, 2025.
Class B Shares
Each Class B share entitles its holder to receive a minimum annual preferred dividend out of the distributable profits at the end of each fiscal year the share is outstanding equal to €0.01 per Class B share, if the aggregate preferred dividend does not exceed the distributable profits for that year and provided that the distribution of dividends has been approved by our shareholders. In any given fiscal year, we will pay a preferred dividend to the holders of the Class B shares before any dividend out of the distributable profits for such fiscal year is paid to the holders of Class A shares. The preferred dividend on all issued Class B shares will be paid by us within the nine months following the end of that fiscal year, in an amount not to exceed the distributable profits obtained during that fiscal year. In 2025, we paid interim dividends of €0.15 gross per Class B share.
Dividend Payments
In 2025, we paid an interim cash dividend on August 13, 2025 of €0.15 gross per share (regardless of share class), for a total distribution of €102 million. In addition, our Board proposed that the profit of Grifols, S.A. for the year ended December 31, 2025 be distributed by allocating €31 million to voluntary reserves and distributing €161 million in dividends, consisting of €158 million of dividends (which includes the €102 million interim dividend already paid) and a mandatory preferred dividend of €3 million attributable to our Class B shares.
See Item 5 of this Part I, “Operating and Financial Review and Prospects—A. Operating Results—Subsequent Events.”
Our Class A shares have been listed on the Spanish Stock Exchanges since we completed our initial public offering on May 17, 2006 and are quoted on the Spanish Automated Quotation System under the ticker symbol “GRF.”
Our Class B shares have been listed on the Spanish Stock Exchanges since June 2, 2011 and quoted on the Spanish Automated Quotation System under the ticker symbol “GRF.P.”
Our Class A ADSs are not listed on a national exchange and have traded on the Over-the-Counter Bulletin Board, an electronic stock listing service provided by NASDAQ, since July 2009.
Our Class B ADSs have been listed and traded on the NASDAQ Global Select Market under the symbol “GRFS” since June 2, 2011. Each Class B ADS represents one Class B share.
Not Applicable
Our Class A shares have been listed on the Spanish Stock Exchanges since May 17, 2006 and are quoted on the Spanish Automated Quotation System under the ticker symbol “GRF.” Our Class B shares were issued as part of the consideration for the Talecris acquisition and were listed on the Spanish Stock Exchanges on June 2, 2011 and quoted on the Spanish Automated Quotation System under the ticker symbol “GRF.P.”
Our Class B ADSs have been listed and traded on the NASDAQ Global Select Market under the symbol “GFRS” since June 2, 2011.
Spanish Securities Market
The Spanish Stock Exchanges consist of four stock exchanges located in Madrid, Barcelona, Bilbao and Valencia. The majority of the transactions conducted on them are done through the Spanish Automated Quotation System. During 2025, the Spanish Automated Quotation System accounted for the majority of the total trading volume of equity securities on the Spanish Stock Exchanges.
Spanish Automated Quotation System
The Spanish Stock Exchange Interconnection System (Sistema de Interconexión Bursátil Español, or “SIBE”, hereinafter referred to as the Spanish Automated Quotation System) was introduced in 1989 and links the Spanish Stock Exchanges, providing those securities listed on it with a uniform continuous market that eliminates most of the differences among the Spanish Stock Exchanges. Its operation is currently governed by Sociedad de Bolsas Circular 1/2026, of January 12, 2026.
The principal feature of the system is the computerized matching of buy and sell orders at the time of entry of the order. Each order is executed as soon as a matching order is entered, but can be modified or canceled until executed. The activity of the market can be continuously monitored by investors and brokers. The Spanish Automated Quotation System is operated and regulated by the Sociedad de Bolsas, a corporation owned by the companies that manage the Spanish Stock Exchanges. All trades on the Spanish Automated Quotation System must be placed through a bank, brokerage firm, an official stock broker or a dealer firm member of a local exchange directly.
There is a pre-opening auction held from 8:30 a.m. to 9:00 a.m. CET (UTC+1) each trading day, during which orders are placed. The computerized trading hours (open session) are from 9:00 a.m. to 5:30 p.m. CET (UTC+1), when continuous trading is carried out. Each session ends with a five-minute auction, between 5:30 and 5:35 p.m. CET (UTC+1), with a random closedown of 30 seconds. The price resulting from each auction is the closing price of the session. Following the closing auction, there is also a short “trading at last” phase during which trades meeting certain conditions are executed at the official closing price.
On March 29, 2021, new rules came into effect regarding the functioning of the Spanish Automated Quotation System, which, among other things, regulates the maximum price fluctuations in the price of stocks. Under the new rules, each stock in the continuous market is assigned a static and a dynamic range within which the price can fluctuate. The price of a stock may rise or fall by its static range (which is public and calculated according to the stock’s average historic price volatility) above or below its opening price (which is the closing price of the previous session). When the stock trades outside of this range, the trading of the stock is suspended for five minutes, during which an auction takes place. After this auction, the price of the stock can once again rise or fall by its static range above or below its last auction price (which will be considered as the new static price before triggering another auction). Furthermore, the price of a stock cannot rise or fall by more than its dynamic price range (which is public and calculated according to the stock’s average intra-day volatility), from the last price at which it has traded. If the price variation exceeds the stock’s dynamic range, a five-minute auction is triggered.
Moreover, there is a block market (el mercado de bloques) allowing for block trades between buyers and sellers from 9:00 a.m. to 5:30 p.m. CET (UTC+1) during the trading session. Under certain conditions, this market allows cross-transactions of trades at prices different from prevailing market prices. Trading in the block market is subject to certain limits with regard to price deviations and volumes.
Between 5:40 p.m. and 8:00 p.m. CET (UTC+1), certain trades may occur benefiting from an exemption to the pre-trade transparency requirements.
Clearance and Settlement System
Until April 1, 2003, transactions carried out on the Spanish Stock Exchanges and the continuous market were cleared and settled through the Servicio de Compensación y Liquidación de Valores, S.A. (whose commercial name is Iberclear). Since April 1, 2003, the settlement and clearance of all trades on the Spanish Stock Exchanges, the Public Debt Market (Mercado de Deuda Pública), the AIAF Fixed Income Market (Mercado AIAF de Renta Fija) and the Market for Latin-American Stocks in Euros (Mercado de Valores Latinoamericanos en Euros) as well as any securities trading on other official regulated markets and multilateral trading systems that have appointed Iberclear for such purposes, have been made through Iberclear, which was formed as a result of a merger between the Servicio de Compensación y Liquidación de Valores, S.A and Central de Anotaciones del Mercado de Deuda Pública, which was managed by the Bank of Spain.
Book-entry System
Ownership of shares listed on any Spanish Stock Exchange is required to be represented by entries in a register maintained by Iberclear, and transfers or changes in ownership are effected by entries in such register. The securities register system is structured in two levels: the central registry managed by Iberclear, which keeps the securities balances of the participants, and a detailed registry managed by the participants where securities are listed by holder’s name.
Securities Market Legislation
The Spanish Securities Market Act (today known as Ley 6/2023, de 17 de marzo, de los Mercados de Valores y de los Servicios de Inversión), or Securities Market Act, which first came into effect in 1989, among other things:
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The Securities Market Act was further amended by Law 44/2002 (November 22, 2002) on reform measures of the financial system, which introduced certain modifications to the laws governing financial markets and corporations generally, including:
On July 17, 2003, the Securities Market Act was amended by Law 26/2003 in order to reinforce the transparency of listed companies. It introduced:
On March 11, 2005, Royal Decree Law 5/2005 was approved, modifying the Securities Market Act in order to implement Directive 2003/71/EC of the European Parliament and of the Council of the European Union, or Council, on the prospectus to be published when securities are offered to the public or admitted to trading. The Directive (i) harmonizes the requirements for the process of approval of prospectuses, which enables a prospectus to be valid throughout the European Union and (ii) incorporates the application of the country-of-origin principle later set forth in Spanish Royal Decree, or Royal Decree, 1362/2007.
Law 6/2007, of April 12, 2007, amended the Securities Market Act to modify the rules for takeover bids and for issuer transparency. This Law came into effect on August 13, 2007, and partially integrates into the Spanish legal system Directive 2004/25/EC of the European Parliament and of the Council, of April 21, 2004, on takeover bids and Directive 2004/109/EC of the European Parliament and of the Council, of December 15, 2004, on the harmonization of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market and amending Directive 2001/34/EC. This Law was further developed by Royal Decree 1066/2007, of July 27, 2007, on rules applicable to takeover bids for securities; by Royal Decree 1362/2007, of October 19, 2007, on transparency requirements for issuers of listed securities; and by Royal Decree 1698/2012, of December 21, 2012, to implement Directive 2010/73/EC of the European Parliament and of the Council, of December 24, 2010 (amending Directive 2003/71/CE and Directive 2004/109/EC).
Law 6/2007 (i) introduced several changes to the periodic financial information (annual, biannual and quarterly) to be published by issuers of listed securities and (ii) introduced new developments to the system that establishes the duty to provide notice of significant stakes in an enterprise. These duties include notification requirements such as:
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Royal Legislative Decree 1/2010, of July 2, 2010, approved the Spanish Companies Act in order to consolidate and clarify the laws applicable to public limited companies, limited share partnerships and limited liability companies.
Law 2/2011, of March 4, 2011, on Sustainable Economy (Ley de Economía Sostenible) amended the Securities Market Act’s provisions related to the requirements for annual reports on corporate governance and management reports. The Law also made certain corporate governance and shareholder disclosure recommendations in the Spanish Unified Good Governance Code for Listed Companies (Código Unificado de Buen Gobierno de las Sociedades Cotizadas, the “CNMV Governance Code), regarding the composition of boards of directors and its committees and the qualification of directors as executive, proprietary or independent mandatory. The CNMV Governance Code for Listed Companies was approved in 2015 and further revised in June 2020 and is currently under review by the CNMV. It unified the recommendations and principles that are applicable to Spanish listed companies; removed some principles and recommendations of the CNMV Governance Code that were written into Spanish legislation and introduced some recommendations on the corporate social responsibility of listed companies.
Law 25/2011, of August 1, 2011, amended the Securities Market Act to implement Directive 2007/36/CE of the European Parliament and of the Council, regarding the exercise of certain rights of the shareholders of listed companies, to simplify and promote the right to information and shareholder voting rights.
Law 1/2012, of June 22, 2012, amended the Spanish Companies Act by making corporate websites mandatory for listed companies and introducing other new requirements regarding the creation, amendment, transfer and removal of corporate websites, as well as the obligations of directors arising in connection with the contents of such websites.
Regulation (EU) No. 596/2014, on market abuse (the “MAR”), and its implementing regulations, which was directly applicable in all European Union member states, came into force in 2016 with the aim to ensure that European Union regulation keeps pace with market developments in order to combat market abuse on financial markets as well as across commodity and related derivative markets.
Law 31/2014, of December 3, 2014, amended the Spanish Companies Act to improve the corporate governance practices, increase management efficiency and increase the transparency of companies listed on a Spanish Stock Exchange.
Regulation (EU) No. 2017/1129, of June 14, 2017 (the “Prospectus Regulation”), which was directly applicable in all European Union member states, came into full force in 2019 to regulate the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC.
Royal Legislative Decree 19/2018, of November 23, 2018, on payment services and other urgent financial measures amends among others, the Securities Market Act in order to integrate into the Spanish legal system, and Regulation (EU) No. 596/2014, on market abuse. The main novelties introduced to the Securities Market Act are (i) the distinction between the concepts of inside information and relevant information, (ii) the removal of the obligation to have an internal code of conduct for securities markets and (iii) the reduction of the notification threshold of people with management responsibilities.
On December 28, 2018, the Spanish Commercial Code, the Companies Act and the Audit Act were amended by Law 11/2018 in order to reinforce the disclosure of non-financial and diversity information, among others, of listed companies. It introduced information and diversity obligations including (i) the obligation to prepare a non-financial information statement on environmental matters, social and employee-related matters, respect for human rights, anti-corruption and bribery matters and society matters and (ii) the obligation to ensure that the selection procedures for Company directors facilitate diversity in relation to age, disability and training as well as gender, experience and knowledge.
On June 26, 2020, the CNMV approved the partial review of the CNMV Governance Code. The review updated and adapted various recommendations of such code to various intervening legal amendments approved since its publication and clarified the scope of others that had raised certain doubts. The four key elements of the reform were: (i) promoting the presence of women in boards of directors; (ii) greater importance of non-financial information and sustainability; (iii) more attention to reputational risk and, in general, non-financial risks; and (iv) clarification of aspects related to the remuneration of the board members.
As a result of the amendment of the CNMV Governance Code referred to above, Circular 1/2020 of October 6, 2020, amended (i) Circular 5/2013 of June 12, 2013, by establishing a new template for the annual corporate governance report for listed public companies, savings banks and other entities that issue securities admitted for trading on official securities markets and (ii) Circular 4/2013 of June 12, 2013, by establishing a new template for the annual report on remuneration of directors of listed public companies and members of boards of directors and control committees of savings banks that issue securities admitted to trading on official securities markets.
Law 5/2021, of April 12, 2021, among other regulations, amended the Spanish Companies Act, as well as the Spanish Securities Market Act. The purpose of this law is to transpose into Spanish Law Directive (EU) 2017/828 of the European Parliament and of the Council of 17 May 2017 amending Directive 2007/36/EC with respect to the encouragement of long-term shareholder engagement in listed companies.
As a result of the amendment of the Spanish Companies Act and the Spanish Securities Market Act referred to above, Circular 3/2021 of September 28, 2021, amended (i) Circular 4/2013 of June 12, 2013, by establishing a new template for the annual report on remuneration of directors of listed public companies and members of boards of directors and control committees of savings banks that issue securities admitted to trading on official securities markets and (ii) Circular 5/2013 of June 12, 2013, by establishing a new template for the annual corporate governance report for listed public companies, savings banks and other entities that issue securities admitted for trading on official securities markets.
On May 26, 2022, Circular 2/2022 of the CNMV was approved. This circular establishes the new forms to be used to report significant shareholding in entities whose securities are admitted to trading on a regulated market and to report any transaction that an issuer makes with its treasury shares and includes certain new provisions applicable to market makers.
Law 6/2023, of March 17, 2023, approved the Securities Market Act, repealing the former securities market act from 2015. The new Securities Market Act contains certain adjustments in relation to the 2015 legislation meant to improve its organization and eliminate a number of inconsistencies. In order to develop the Securities Market Act, the following regulations were approved: (i) Royal Decree 813/2023, on the legal regime of investment services companies and other entities that provide investment services; (ii) Royal Decree 814/2023, on financial instruments, admission to trading, registration of negotiable securities and market infrastructures; and (iii) Royal Decree 815/2023, in relation to the official registries of the National Securities Market Commission, cooperation with other authorities and supervision of investment services companies.
The MAR and the Prospectus Regulation have been amended by Regulation (EU) 2024/2809 of the European Parliament and of the Council of 23 October 2024 (the “Listing Act Regulation”). Among other things, the Listing Act Regulation updates certain disclosure requirements, streamlines prospectus disclosure for secondary issuances and broadens the available exemptions from the obligation to publish a prospectus. While many of the changes under the Listing Act took effect on December 4, 2024 and March 5, 2026, some provisions will not be applicable until June 5, 2026.
The following is a summary of the material terms of our Articles of Association and Board Regulations, as amended and currently in effect. This summary is not meant to be complete and is qualified in its entirety by reference to each of the Articles of Association and Board Regulations. Because this is a summary, it does not contain all the information that may be important to you. You should read the Articles of Association and Board Regulations carefully. The current Articles of Association are included as Exhibit 1.1 and Exhibit 1.2 (English translation) to this annual report on Form 20-F. The Articles of Association and the Board Regulations are also available on our website, which does not form part of this annual report on Form 20-F, at www.grifols.com under the headings “Investors—Corporate Governance—Articles of Association” and “Investors—Corporate Governance—Board of Directors, Regulations.”
The Articles of Association were originally approved and incorporated with the Commercial Registry on June 22, 1987. The Board Regulations were initially approved by the Board on April 5, 2006.
At the general shareholders’ meeting held on May 29, 2015, the shareholders voted to amend our Articles of Association on matters pertaining to corporate governance in order to ensure compliance with the amended Spanish Companies Act. The shareholders renewed the delegation of authority to the Board to effect a two-to-one split of the Class A and Class B shares, within one year following the date of the meeting, by reducing the nominal value and increasing the number of such shares, without changing the total nominal value of the share capital. Finally, the shareholders provided the Board authorization for the derivative acquisition of treasury stock thereby revoking and leaving without effect the authorization granted to the Board during the shareholder meeting on extraordinary matters held on January 25, 2011.
At the general shareholders’ meeting held on May 27, 2016, the shareholders voted to delegate to the Board, with full power of substitution in any of its members, the authority to increase the Company’s share capital at once or in several times and at any given moment, within a maximum term of five (5) years as from the date of the May 27, 2016, general meeting, and in an amount that in no case may exceed half of the Company’s share capital at the time of this authorization. Pursuant to this authorization, the share capital increases will be carried out, if appropriate, by issuing and placing in circulation the new shares (whether of Class A and Class B, exclusively Class A or exclusively Class B), with or without share premium, with a consideration consisting in cash contributions. As long as there are non-voting Class B shares in circulation, the capital increases will observe, when applicable, the provisions of the Company’s Articles of Association as regards the pre-emptive right of acquisition that may correspond in said capital increases. Likewise, as long as Class B shares hold the redemption rights foreseen in paragraph 4 of article 6.bis of the Articles of Association, the nominal value of the Class B shares that may be issued in the execution of this delegation of authorities cannot exceed one fourth of the total amount of the share capital resulting from the capital increase resolution.
At the general shareholders’ meeting held on May 26, 2017, the shareholders voted to amend our Articles of Association concerning the composition and functions of the Audit Committee, in order to conform its content to the latest amendments of the Companies Act introduced by the Audit Act currently in force. The shareholders also voted to amend the regulation of the general shareholders’ meeting, concerning the competences of the general shareholders’ meeting, in order to adapt its content to the latest amendments of the Companies Act, introduced by Law 5/2015 of promotion of business financing (Ley 5/2005 de fomento de la financiación empresarial), on matters of issuance of bonds and other securities. The amendment consists of eliminating the issuance of numbered series of bonds or other securities, whether convertible or not, that may recognize or create a debt expressly as a competence of the general shareholders’ meeting. The shareholders also renewed the delegation of authority to apply for the listing of the Class A shares on NASDAQ, via Class A ADSs, within three years following the date of the meeting.
At the general shareholders’ meeting held on May 24, 2019, the shareholders voted to amend our Articles of Association and the regulations of the general shareholders’ meeting with respect to the valid casting of votes through distance voting systems of the general shareholders’ meeting in order to extend the deadline for receipt of votes until immediately before midnight on the day prior to the date that the general shareholders’ meeting is scheduled at its first call or second call.
At the general shareholders’ meeting held on October 9, 2020, the shareholders voted to amend our Articles of Association and the regulations of the general shareholders’ meeting with respect to the right to attend, proxy granting and representation at the general shareholders’ meeting, with the purpose of expressly establishing the possibility of attending the general shareholders’ meeting by remote, simultaneous and bidirectional connection via telematics means. The shareholders also renewed the delegation of authority to the Board for the derivative acquisition of treasury stock, thereby revoking and voiding the authorization granted to the Board during the general shareholders’ meeting held on May 29, 2015. Such authorization is granted for a maximum term of five years. Further, the shareholders renewed the delegation of authority to apply for the listing of the Class A shares on NASDAQ, via Class A ADSs, within three years following the date of the meeting.
At the general shareholders’ meeting held on May 21, 2021, the shareholders voted to renew the delegation of authority to the Board to increase the company’s share capital, thereby revoking and voiding the authorization granted to the Board during the general shareholders’ meeting held on May 27, 2016. Such authorization is granted for a maximum term of five years as from the date of the general shareholders’ meeting.
At the general shareholders’ meeting held on June 10, 2022, the shareholders voted to amend our Articles of Association and regulations of the general shareholders’ meeting in order to conform their wording to the latest amendments of the Spanish corporate law rules and regulations, with amendments regarding (1) the right to attend, proxy granting and representation at the general shareholders’ meeting and the casting of votes through distance voting systems; (2) the remuneration of the Board of Directors; (3) the Audit Committee and annual accounts; (4) the information rights available for shareholders prior to the holding of the general meeting; and (5) the virtual attendance, distance voting and the minutes of the general shareholders’ meeting.
At the general shareholders’ meeting held on June 16, 2023, the shareholders voted to amend our Articles of Association in order to include the delivery of shares or shares options or amounts referred to the value of the shares, as remuneration to directors for the performance of executive duties. Further, the shareholders renewed the delegation of authority to apply for the listing of the Class A shares on NASDAQ, via Class A ADSs, until June 16, 2026.
At the general shareholders’ meeting held on June 14, 2024, the shareholders of Grifols voted to amend our Articles of Association in order to change the registered offices of the Company.
At the general shareholders’ meeting held on June 5, 2025, the shareholders voted to amend the regulations of the general shareholders’ meeting to adequate its content to the applicable law currently in force, as well as for introducing technical improvements in its wording. The shareholders also renewed the delegation of authority to the Board for the derivative acquisition of treasury stock, thereby revoking and voiding the authorization granted to the Board during the general shareholders’ meeting held on October 9, 2020. Such authorization will expire on June 5, 2030.
The Board, with full power of substitution in any of its members, has the authority to set the terms and conditions of the capital increases and the characteristics of the shares in all aspects not foreseen by the general shareholders’ meeting, as well as to freely offer the new unsubscribed shares within the term(s) of exercise of the pre-emptive right of subscription; establish that, in the event of an incomplete subscription, the share capital will be increased only in the amount of the subscriptions effectively carried out; redraft the articles of the Articles of Association related to share capital and number of shares; exclude, pursuant to the provisions of article 506 of the Companies Act, the pre-emptive right in the terms and conditions set forth therein and up to a maximum of 20% of the Company’s share capital; apply for, when appropriate, the listing of the shares issued pursuant to this authorization, as well as to carry out all the necessary actions and procedures and to file the documents that might be required before the competent bodies of the above-mentioned stock exchange markets, for admission to listing of the new shares issued as a consequence of the agreed capital increase; it is expressly put on record that Grifols agrees to be bound by already existing and future rules related to the Stock Exchange matters and, specially, as regards contracting, permanence and exclusion from official listing; request the inclusion of the new shares in the accounting registries of the company Sociedad de Gestión de los Sistemas de Registro, Compensación y Liquidación de Valores, S.A.U. (Iberclear).
The full text of the amendments to the Articles of Association detailed above is available on our website, which does not form part of this annual report on Form 20-F, at www.grifols.com under the heading “Investors—Corporate Governance.”
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As of December 31, 2025, our share capital was €119,603,705 and comprised:
All of our shares are fully paid and non-assessable. Both share classes are issued in book-entry form, governed by the Securities Market Act, as amended, and such other provisions as may be applicable. The book-entry registry is maintained by Iberclear and its participant entities.
Register
We are a public limited trading company registered with the Commercial Registry of Barcelona. Our fiscal identification number is A-58389123.
Our registered and principal executive office is located at Avinguda de la Generalitat, 152-158 Parque Empresarial Can Sant Joan, 08174 Sant Cugat del Vallès, Barcelona, Spain. We were incorporated on June 22, 1987. Our fiscal year runs from January 1 to December 31.
Corporate Purpose
Article 2 of the Articles of Association states that our corporate purpose is to provide administration, management and supervision services of companies and businesses as well as investments in personal and real estate assets.
Under Article 31 of the Board Regulations, a director shall abstain from attending or intervening in deliberations that affect matters in which he/she (or any person related to him/her) is personally involved, directly or indirectly. A director cannot carry out professional or commercial transactions with us, directly or indirectly, unless he/she previously informs the Board about the conflict of interest, and the Board, following a report from our Appointments and Remuneration Committee, approves the transaction.
Pursuant to the Policy on the Composition of the Board of Directors initially approved on February 22, 2019 and last amended on November 14, 2025, proposed by the Appointments and Remuneration Committee with the aim of formalizing the procedures and guidelines followed during the selection process of candidates to form part of the Board to favor an appropriate composition of the Board. This Policy pursues two main objectives: (i) to guarantee that any proposal for the appointment or re-election of the members of the Board is based on a prior analysis of the required competences by the Board and (ii) to support knowledge, experience, age and gender diversity.
Under Article 15 of the Board Regulations, the Appointments and Remuneration Committee will in all cases be fully composed of non-executive directors, two of which shall be independent directors, and the chairperson must be an independent director.
The Board, with the advice of the Appointments and Remuneration Committee, sets director compensation. As set forth in Article 20.bis of our Articles of Association the directors’ remuneration shall be approved by the general shareholders’ meeting and shall apply for a maximum of three fiscal years. New directors’ remuneration policies must be approved by the general shareholders’ meeting prior to the last year of applicability of the previous policy, and any new policies approved may apply from the date of approval up to the three following years if so determined by the general shareholders’ meeting. As set forth in Article 27 of the Board Regulations, non-executive directors should be excluded from receiving remuneration linked to our profits or welfare systems, other than shares in Grifols, that they must hold until their resignation as directors. Further, the establishment of equity compensation plans in which members of the Board participate must be authorized in the Articles of Association and requires the shareholders’ prior approval at a shareholders’ meeting. Additionally, the amount of non-executive directors’ remuneration should be calculated in order to incentivize dedication but not become an obstacle to independence.
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For more information regarding related party transactions, see Item 7 of this Part I, “Major Shareholders and Related Party Transactions—B. Related Party Transactions.”
We do not impose an age limit requirement for the retirement or non-retirement of directors. We also do not impose a shareholding requirement for director qualification. Article 6 of the Board Regulations does provide, however, among other circumstances, that a director cannot qualify as an independent external director if he or she has a significant shareholding in us.
For information regarding the provisions of the Articles of Association as applied to the Board, see Item 6 of this Part I, “Directors, Senior Management and Employees—A. Directors and Senior Management—Directors” and “Directors, Senior Management and Employees—C. Board Practices.”
Shareholder Rights
The following summary of material considerations concerning our share capital briefly describes certain material provisions of the Articles of Association and Spanish law relating to our share capital. Because it is a summary, it is not meant to be complete, is qualified by reference to the applicable Spanish laws and our Articles of Association and does not contain all the information that may be important to you.
Neither Spanish law nor our Articles of Association limit the right to own our securities, including the rights of non-resident or foreign shareholders to hold or exercise voting rights on the securities.
Under Spanish law, the rights of shareholders may be changed only by an amendment to the articles of association of a company that complies with the requirements explained below under “—Class A Shares—shareholders’ meetings and Voting Rights.” Our Articles of Association do not further specify what actions or quorums are required to change the rights of our shareholders, other than that they classify an amendment thereto as an extraordinary matter, as described below in “—Class B Shares—Separate Vote at General Shareholder Meetings on Extraordinary Matters.”
Shareholders’ Meetings and Voting Rights
Pursuant to Article 13 of our Articles of Association and the Spanish Companies Act, the annual general shareholders’ ordinary meeting shall be held during the first six months of each fiscal year on a date fixed by the Board. Resolutions presented at duly constituted general shareholders’ meetings are, except as indicated herein, passed by a simple majority vote of the voting capital present or represented at the meeting.
Extraordinary meetings may be called by the Board whenever it deems it appropriate or at the request of one or more shareholders representing at least 3% of our share capital. The requesting shareholders must state in their request the matters to be addressed at the meeting. Per Spanish Law and the Articles of Association, we are required to publish a “calling of the meeting,” which sets forth the matters to be voted on at each general shareholders’ meeting, at least one month prior to the date set for the meeting in at least: (i) the Official Gazette of the Commercial Registry (Boletín Oficial del Registro Mercantil) or one of the local newspapers of wide circulation in the province where we are domiciled (currently Barcelona, Spain); (ii) CNMV’s website; and (iii) our website.
Holders of ordinary and Class B shares duly registered in the book-entry records maintained by Iberclear and its participant entities at least five days prior to the day on which a shareholders’ meeting is scheduled, in the manner provided in the notice for such meeting, may attend such meeting (in person or represented by proxy) and, where so entitled, may vote. Holders of our Class B shares generally do not have voting rights, except with respect to certain extraordinary matters that require approval by a majority of our outstanding Class B shares, as set forth below in “—Class B Shares—Separate Vote at General Shareholder Meetings on Extraordinary Matters.”
For an ordinary or extraordinary general meeting of shareholders to be duly constituted on the first call, the presence in person or by proxy of shareholders representing 25% of our issued voting share capital is required to constitute a quorum and proceed. If a quorum is not obtained on the first call, a meeting is validly convened on the second call regardless of the share capital in attendance.
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Under Spanish law, the following shareholder actions require approval by the affirmative vote of the holders of a majority of our Class A shares present in person or represented by proxy at a duly constituted meeting of holders of our Class A shares at which meeting, if (i) on first call, a quorum of at least 50% of the issued voting share capital is present or represented by proxy or (ii) on second call, a quorum of at least 25% of the issued voting share capital is present or represented by proxy (unless on such second call less than 50% of the issued voting share capital is present or represented by proxy, in which case those matters require the affirmative vote of at least two-thirds of the share capital present or represented at such meeting):
For purposes of determining the quorum, those shareholders who vote by mail or through the internet are counted as being present at the meeting, as provided by the regulations of the general shareholders’ meeting of Grifols, S.A (Reglamento de la Junta General de Accionistas). Such regulations are available on our website, which does not form part of this annual report on Form 20-F, at www.grifols.com under the heading “Investors—Corporate Governance—Shareholders’ General Meeting—Regulations of the general shareholders’ meeting.”
In general, resolutions passed at a general shareholders’ meeting are binding upon all shareholders. In very limited circumstances, Spanish law gives dissenting or absent shareholders, including those holding Class B shares, the right to have their Grifols’ shares redeemed by us at prices determined in accordance with established formulas or criteria.
Payment of dividends must be proposed by the Board and authorized by our shareholders at a general shareholders’ meeting. Interim dividends may be declared by the Board on account of profits for the then current fiscal year, subject to certain limitations.
Spanish law requires each company to apply at least 10% of its net income each year to a legal reserve until the balance of such reserve is equivalent to at least 20% of such company’s issued share capital. A company’s legal reserve is not available for distribution to its shareholders except upon such company’s liquidation. According to Spanish law, dividends may only be paid out of profits (after deduction of any amounts required to be applied to the legal reserve) or distributable reserves and only if the value of a company’s net worth is not, and as a result of distribution would not be, less than such company’s share capital.
In addition, no profits may be distributed unless the amount of the distributable reserves is at least equal to the amount of research and development expenses recorded as an asset on a company’s consolidated balance sheet.
Spanish law also requires the creation of a non-distributable reserve equal to the amount of goodwill recorded as an asset on a company’s consolidated balance sheet and that an amount at least equal to 5% of such goodwill be transferred from the profit from each financial year to such non-distributable reserve until such time as the non-distributable reserve is of an amount at least equal to the goodwill recorded on such company’s consolidated balance sheet. If, in any given financial year, there are no or insufficient profits to transfer an amount equal to 5% of the goodwill recorded as an asset on a company’s consolidated financial statement, Spanish law requires that the shortfall be transferred from freely distributable reserves to the non-distributable legal reserve.
In the event of a reduction in share capital to offset losses, dividends may not be distributed until the legal reserve reaches 10% of the new share capital.
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Distributions of dividends to our Class A shareholders will be made in proportion to the capital that they have paid up. The shareholders at the general shareholders’ meeting shall decide the amount, time and form of payment of the dividends. If these details are not so determined, the dividend will be payable at our registered office on the day following the date of the resolution.
The right to a dividend lapses and reverts to us if it is not claimed within five years after it becomes payable. Dividends payable by us to non-residents of Spain may be subject to a Spanish withholding tax of 19%, effective January 1, 2016. However, residents of certain countries are entitled to the benefits of the Convention Between the United States of America and the Kingdom of Spain for the Avoidance of Double Taxation and the Prevention of Fiscal Evasion with Respect to Taxes on Income, as described below in “—E. Taxation—Spanish Tax Considerations.”
As set forth below under “—Class B Shares—Preferred Dividend,” since the issuance of our Class B shares, the dividend rights of our Class A shareholders have been subordinated to the €0.01 per share preferred dividend of our Class B shares.
Liquidation Rights
Upon our winding-up and liquidation, holders of our Class A shares and Class B shares will be entitled to receive a pro rata portion of any assets remaining after the payment of our debts, taxes and the expenses of the liquidation as follows: (i) before any amount is distributed to the holders of Class A shares, the holders of Class B shares will receive the nominal value and share premium paid up for such Class B shares at the time of issuance and (ii) once such liquidation preference is received, the holders of the Class A shares and Class B shares will share pari passu in the amounts distributed.
Subscription (or Preemptive) Rights and Increases of Share Capital
Pursuant to the Spanish Companies Act, shareholders and holders of convertible bonds have subscription (or preemptive) rights to subscribe for any new shares (or other securities convertible into, or exchangeable for, shares) issued by a company in a capital increase via monetary contributions.
In accordance with the Spanish Companies Act, such subscription (or preemptive) rights may be waived under special circumstances by a resolution passed at a meeting of shareholders or the Board (such as when we listed on the Spanish Stock Exchanges), and the general shareholders’ meeting delegates to the Board the right to increase the share capital or to issue securities convertible into, or exchangeable for, shares and to waive subscription (or preemptive) rights). See Item 3 of this Part I, “Key Information—D. Risk Factors—Risks Relating to Our Shares and American Depositary Shares—Subscription (or preemptive) rights may be unavailable to U.S. holders of our shares or ADSs.”
Further, subscription (or preemptive) rights, in any event, will not be available in the event of certain capital increases, such as those in which we receive an in-kind contribution, those effected to meet the requirements of a convertible bond issue or those for a merger in which shares are issued as consideration. Subscription (or preemptive) rights are transferable, may be traded on the Spanish Automated Quotation System and may be of value to existing shareholders because new shares may be offered for subscription at prices lower than prevailing market prices. In the case of a share capital increase against reserves, the same rule applies to the free allotment (derecho de asignación gratuita) rights.
Finally, as described below in “—Class B Shares—Subscription Rights,” in connection with an issuance of securities where subscription (or preemptive) rights apply, our Class B shares may only be granted preemptive rights with respect to additional Class B shares if our Class A shares are granted preemptive rights with respect to additional Class A shares. The preemptive rights of each class must be otherwise equal.
Registration and Transfers
Our Class A shares are in book-entry form on Iberclear and are indivisible. Joint holders of one share must designate a single person to exercise their shareholders’ rights, but they are jointly and severally liable to us for all the obligations flowing from their status as shareholders, such as the payment of any pending capital calls.
Iberclear maintains the central registry reflecting the number of shares held by each of its participant entities. Each participant entity, in turn, maintains a registry of the owners of such shares.
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Transfers of shares quoted on the Spanish Stock Exchanges are normally made through credit entities or investment companies that are members of the Spanish Stock Exchanges.
Reporting Requirements
Pursuant to Royal Decree 1362/2007, any individual or legal entity that, by whatever means, acquires or transfers shares with voting rights in a company for which Spain is listed as the Country of Origin (Estado Miembro) (as defined therein) and which is listed on an official secondary securities market or other regulated market in the European Union must notify the issuer and the CNMV, if, as a result of such transaction, the proportion of voting rights held by that individual or legal entity reaches, exceeds or thereafter falls below a 3% threshold of that company’s total voting rights. The notification obligations are also triggered at thresholds of 5% and multiples thereof (excluding 55%, 65%, 85%, 95% and 100%). The applicable threshold is 1% (or its successive multiples thereof) for persons or entities located in designated “tax havens” (as defined in Royal Decree 1080/1991) or other jurisdictions lacking adequate supervision.
The individual or legal entity obliged to provide the notification must serve the notification by means of the form approved by the CNMV from time to time for such purpose, within four business days from the date on which the transaction is acknowledged. Royal Decree 1362/2007 deems that a transaction is “acknowledged” within two business days from the date on which such transaction is entered into.
The reporting requirements apply not only to the purchase or transfer of voting shares, but also to those transactions in which, without a purchase or transfer, the proportion of voting rights of an individual or legal entity reaches, exceeds or thereafter falls below the threshold that triggers the obligation to report as a consequence of a change in the total number of voting rights of a company on the basis of the information reported to the CNMV and disclosed by such individual or legal entity.
Regardless of the actual ownership of the voting shares, any individual or legal entity with a right to acquire, transfer or exercise voting rights of the shares, and any individual or legal entity that owns, acquires or transfers, whether directly or indirectly, other securities or financial instruments that grant a right to acquire shares with voting rights, will also have an obligation to notify us and the CNMV of the holding of a significant stake in accordance with the regulations.
Furthermore, all members of the Board must report to both us and the CNMV the percentage and number of voting rights in Grifols held by them at the time of becoming or ceasing to be a member of the Board. All members of the Board must also report any change in the percentage of voting rights they hold, regardless of the amount, as a result of any acquisition or disposition of our shares or voting rights, or financial instruments that carry a right to acquire or dispose of shares that have voting rights attached, including any stock-based compensation that they may receive pursuant to any of our compensation plans.
In addition, pursuant to the Securities Market Act, any member of the Board and any parties closely related to any member of the Board must similarly report any acquisition or disposal of our shares (in this case, either Class A or Class B shares), derivatives or other financial instruments relating to our shares regardless of the size, including information on the percentage of voting rights which they hold as a result of the relevant transaction within five business days of such transaction. In this respect, Regulation (EU) No. 596/2014, on market abuse, introduces certain changes as regards notifications from directors. From a practical viewpoint, the transactions that may be notified are broadened, the notification period is reduced from 5 to 3 business days and the prohibition against directors and executives to trade during 30 calendar days before the publication of an interim or annual financial report (restricted periods or “blackouts”) is regulated. Royal Decree-Law 19/2018, which amends the Securities Market Act and implements Regulation (EU) No. 594/2014, on market abuse, establishes that persons discharging managerial responsibilities, as well as persons closely associated with them, must report to Grifols and the CNMV any acquisition or disposal of our shares (in this case, either Class A or Class B shares), derivatives or other financial instruments relating to our shares, once the sum of the amounts of all transactions made within a calendar year reaches the amount of €20,000.
Additional disclosure obligations apply in respect of voting agreements. In this respect, the Spanish Companies Act requires parties to disclose certain types of shareholders’ agreements that affect the exercise of voting rights at a general shareholders’ meeting or contain restrictions or conditions on the transferability of shares or bonds that are convertible or exchangeable into shares.
Moreover, persons holding a net aggregate short position in our shares must report the short position to the CNMV on a confidential basis whenever it reaches 0.2% and notify the CNMV of any subsequent decrease or increase by 0.1% (and successive multiples thereof) within the day immediately following the relevant trade. The CNMV publishes individual net short positions of 0.5% or more and aggregate information on net short positions between 0.2% and 0.5%.
The Articles of Association do not contain additional provisions governing the ownership threshold above which shareholder ownership must be disclosed.
Our Class B shares have substantially similar dividend and other economic rights as our Class A shares, summarized above in “—Class A Shares,” but differ from the Class A shares in some important respects that are outlined below.
Holders of our Class B shares generally do not have voting rights, except with respect to certain extraordinary matters, with respect to which approval by a majority of our outstanding Class B shares is required.
Separate Vote at General Shareholder Meetings on Extraordinary Matters
Notwithstanding the lack of voting rights of our Class B shares generally, resolutions on the matters detailed below (each, an “extraordinary matter”) require the approval of a majority of our outstanding Class B shares.
The general shareholders’ meeting has the power to decide on all matters assigned to it by law or by the Articles of Association and, in particular, without limitation to the foregoing, shall be the only corporate body or office entitled to decide on these extraordinary matters.
Preferred Dividend
Each of our Class B shares entitles its holder to receive a minimum annual preferred dividend out of the distributable profits at the end of each fiscal year the share is outstanding equal to €0.01 per Class B share. In any given fiscal year, we will pay a preferred dividend to the holders of our Class B shares before any dividend out of the distributable profits for such fiscal year is paid to the holders of our Class A shares. The preferred dividend on all issued Class B shares will be paid by us within the nine months following the end of that fiscal year, in an amount not to exceed the distributable profits obtained by us during that fiscal year.
If, during a fiscal year, we have not obtained sufficient distributable profits to pay in full, out of those profits, the preferred dividend on all the Class B shares outstanding, the preferred dividend amount exceeding the distributable profits obtained by us will not be paid and will not be accumulated as a dividend payable in the future.
Lack of payment, total or partial, of the preferred dividend during a fiscal year due to insufficient distributable profits to pay in full the preferred dividend for that fiscal year will not cause our Class B shares to recover any voting rights.
As set forth above in “—Class A Shares—Dividends,” the dividend rights of our Class A shareholders are subordinated to the preferred dividend described in this section.
Other Dividends
Each Class B share is entitled to receive, in addition to the preferred dividend referred to above, the same dividends and other distributions (in each case, whether in cash, securities of Grifols or any of our subsidiaries, or any other securities, assets or rights) as one Class A share. Each Class B share is treated as one Class A share for the purpose of any dividends or other distributions made on our Class A shares, including as to the timing of the declaration and payment of any such dividend or distribution.
Redemption Rights
Each holder of our Class B shares is entitled to redeem those shares as set forth in this section if a tender offer for all or part of our share capital is made and settled (in whole or in part), except if holders of our Class B shares were entitled to (i) participate in such offer and (ii) have their shares acquired in such offer equally and on the same terms as holders of our Class A shares (including, without limitation, for the same consideration).
Upon the closing and settlement (in whole or in part) of a tender offer for our shares in which holders of our Class B shares were not entitled to (i) participate and (ii) have their shares acquired in such offer equally and on the same terms as holders of our Class A shares (including, without limitation, for the same consideration), the redemption process will follow the process detailed below.
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The number of our Class B shares redeemed shall not represent a percentage over our total Class B shares issued and outstanding at the time the tender offer is made in excess of the percentage that the sum of our Class A shares (i) to which the tender offer is addressed, (ii) held by the offerors in that offer and (iii) held by persons acting in concert with the offerors or by persons having reached an agreement relating to the offer with the offerors represent over the total Class A shares issued and outstanding at the time the tender offer causing the redemption of our Class B shares is made.
Payment of the redemption price will be subject to us having sufficient distributable reserves but, after a tender offer occurs and until the redemption price for our Class B shares is paid in full, we will not be able to declare or pay any dividends nor any other distributions to our shareholders (in each case, whether in cash, securities of Grifols or any of our subsidiaries, or any other securities, assets or rights).
Each Class B share entitles its holder to receive, upon our winding-up and liquidation, an amount equal to the sum of (i) the nominal value of such Class B share and (ii) the share premium paid up for such Class B share when it was subscribed for.
We will pay the liquidation amount to the holders of our Class B shares before any amount on account of liquidation is paid to the holders of our Class A shares.
Each of our Class B shares entitles its holder to receive, in addition to the liquidation preference amount, the same liquidation amount paid for a Class A share.
Subscription Rights
Each Class B share entitles its holder to the same rights (including preferential subscription rights and free allotment rights) as one Class A share in connection with any issuance, granting or sale of (i) any shares in Grifols, (ii) any rights or other securities exercisable for, exchangeable or convertible into shares in Grifols or (iii) any options, warrants or other instruments giving the right to the holder thereof to purchase, convert, subscribe or otherwise receive any securities in Grifols.
As an exception, the preferential subscription rights and the free allotment rights of the Class B shares will only be for new Class B shares or for instruments giving the right to purchase, convert, subscribe for or otherwise receive Class B shares, and the preferential subscription right and the free allotment right of an Class A share will only be for new Class A shares or for instruments giving the right to purchase, convert, subscribe or otherwise receive Class A shares, for each capital increase or issuance that meets the following three requirements: (i) the issuance of Class A shares and Class B shares is in the same proportion of our share capital as they represent at the time the resolution on the capital increase is passed; (ii) grants of preferential subscription rights or free allotment rights, as applicable, to the Class B shares for the Class B shares are under the same terms as the preferential subscription rights or free allotment rights, as applicable, granted to the Class A shares for the Class A shares; and (iii) no other shares or securities are issued.
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Class B shares are in book-entry form on Iberclear and are indivisible, as indicated with respect to Class A shares above in “—Class A Shares—Registration and Transfers.”
Change in Control
The Articles of Association do not contain any provisions that would have the effect of delaying, deferring or preventing a change in control of Grifols.
Changes in Share Capital
Changes in share capital are considered extraordinary matters and must be approved by our shareholders in accordance with the procedures explained above in “—Class A Shares—shareholders’ meetings and Voting Rights” and “—Class B Shares—Separate Vote at General Shareholder Meetings on Extraordinary Matters.”
A capital increase may be effected by issuing new shares or by increasing the par value of existing shares. A capital reduction may be effected by reducing the par value of existing shares or by redeeming or repurchasing existing shares.
426,129,798 Class A Shares are currently issued and outstanding with a par value of €0.25 per share and 261,425,110 Class B Shares are currently issued and outstanding with a par value of €0.05 per share. As of December 31, 2025, our total share capital stands at €119,603,705.
Sinking Fund
The Articles of Association do not contain any sinking fund provisions.
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The following contracts have been entered into by us within the two years immediately preceding the date of this annual report on Form 20-F or contain provisions under which we or another member of the Grifols Group has an obligation or entitlement that is material to us:
2021 Notes
For a summary of the material terms of the 2021 Notes, see Item 5 of this Part I, “Operating and Financial Review and Prospects—B. Liquidity and Capital Resources—Sources of Credit—The 2021 Notes.”
April 2024 Notes
For a summary of the material terms of the April 2024 Notes, see Item 5 of this Part I, “Operating and Financial Review and Prospects—B. Liquidity and Capital Resources—Sources of Credit—The April 2024 Notes.”
December 2024 Notes
For a summary of the material terms of the December 2024 Notes, see Item 5 of this Part I, “Operating and Financial Review and Prospects—B. Liquidity and Capital Resources—Sources of Credit—The December 2024 Notes.”
For a summary of the material terms of the New Credit Facilities, see Item 5 of this Part I, “Operating and Financial Review and Prospects—B. Liquidity and Capital Resources—Sources of Credit—New Credit Facilities.”
Acquisitions
For a summary of the material terms of our acquisitions substantially completed in 2025, 2024 and 2023, see Item 5 of this Part I, “Operating and Financial Review and Prospects—A. Operating Results—Factors Affecting Our Financial Condition and Results of Operations—Acquisitions.”
Restrictions on Foreign Investment
Under present regulations, foreign investors may transfer invested capital, capital gains and dividends out of Spain without limitation on the amount other than applicable taxes. Law 19/2003, of July 4, 2003, as amended, updated Spanish exchange control and money laundering prevention provisions, by recognizing the principle of freedom of the movement of capital between Spanish residents and nonresidents unless they fall within the scope of article 7 bis of Law 19/2003, enacted in December 2022 through Royal Decree-Law 20/2022, or — solely with respect to investments in the defense sector — article 18 of Royal Decree 571/2023, of July 4, 2023.
The law establishes procedures for the declaration of capital movements for purposes of administrative or statistical information and authorizes the Spanish government to take measures which are justified on grounds of public policy or public security and public health. Article 7 bis of Law 19/2003 establishes a screening mechanism for certain investments made by non-E.U. and non-EFTA residents, based on public order, public health and public security reasons. It also provides the mechanism to take exceptional measures with regard to third countries if such measures have been approved by the European Union or by an international organization to which Spain is a party.
Violating the screening mechanism can invalidate transactions, with fines up to the value of the investment. Non-Spanish foreign investors, excluding those in tax havens, must notify the Spanish Registry of Foreign Investments post-investment for statistical, economic and administrative purposes (as established in Royal Decree 571/2023, of July 4). Residents of tax havens require prior and subsequent notifications, except in specific cases. Additional regulations apply to certain industries such as air transportation, mining, and defense-related activities. E.U. residents are generally exempt from these restrictions, except in defense-related sectors and the manufacturing of weapons and explosives for non-military purposes.
Law 10/2010, on the prevention of money laundering and funding of terrorism, was adopted on April 28, 2010 and entered into force on April 30, 2010. This Law requires a person moving (i) paper money and coins in any currency, (ii) bearer checks in any currency or (iii) any other physical medium, including electronic media, designed for use as payment to the bearer to declare such payment to the Spanish exchange control authorities if it exceeds €10,000 (or the foreign currency equivalent).
In General
Treatment of Holders of ADSs
This section describes the material United States federal income and Spanish tax consequences of owning shares or ADSs. It applies to you only if you hold your shares or ADSs as capital assets for tax purposes. This section does not apply to you if you are a member of a special class of holders subject to special rules, including:
This section is based on the Internal Revenue Code of 1986, as amended, or the Code, its legislative history, existing and proposed regulations, published rulings and court decisions, in each case as in effect as of the date hereof and all of which are subject to change, possibly on a retroactive basis, as well as the tax laws of Spain and regulations thereunder and the Convention Between the United States of America and the Kingdom of Spain for the Avoidance of Double Taxation and the Prevention of Fiscal Evasion with Respect to Taxes on Income, or the Treaty, in each case as in effect as of the date hereof and subject to change.
You are a “U.S. Holder” if you are a beneficial owner of shares or ADSs and you are:
An “eligible U.S. Holder” is a U.S. Holder that:
A “non-U.S. Holder” is a beneficial owner of shares or ADSs that is not a U.S. Holder.
In addition, if a partnership (including any entity treated as a partnership for United States federal income tax purposes) is a beneficial owner of shares or ADSs, the tax treatment of a partner in the partnership will generally depend upon the status of the partner and the activities of the partnership. A beneficial owner of shares or ADSs that is a partnership, and partners in such partnership, should consult their own tax advisors regarding the tax consequences of owning and disposing of shares or ADSs.
You should consult your own tax advisor regarding the United States federal, state and local and the Spanish and other tax consequences of owning and disposing of shares and ADSs in your particular circumstances. In particular, you should confirm your status as an eligible U.S. Holder with your advisor and should discuss any possible consequences of failing to qualify as an eligible U.S. Holder.
This discussion addresses only United States federal income taxation and Spanish income taxation, gift and inheritance taxation, wealth taxation and transfer taxation.
Treatment of Holders of ADRs
In general, and taking into account the earlier assumptions, for United States federal income and Spanish tax purposes, if you hold ADRs evidencing ADSs, you will be treated as the owner of the shares represented by those ADRs. Exchanges of shares for ADRs, and ADRs for shares, generally will not be subject to United States federal income or to Spanish tax.
Spanish Tax Considerations
This discussion of Spanish tax consequences applies only to owners of ADSs or shares who are eligible U.S. Holders. The following is a summary of material Spanish tax matters and is not exhaustive of all the possible tax consequences to individuals or entities of the acquisition, ownership and disposition of ADSs or shares.
Taxation of Dividends
Under Spanish law, including Royal Legislative Decree 5/2004, of March 5, 2004, as amended by Law 26/2014 (which is effective from January 1, 2015), on the Non-Resident Income Tax Law, dividends paid by a Spanish resident company to a holder of ordinary shares or ADSs not residing in Spain for tax purposes and not operating through a permanent establishment in Spain are subject to Spanish Non-Resident Income Tax of 19%.
We will levy an initial withholding tax on the gross amount of dividends at a 19% tax rate, following the procedures set forth by the Spanish Ministerial Order, or Order, of April 13, 2000. However, under the Treaty and subject to the fulfillment of certain requirements, individuals and entities may be entitled to a reduced rate of 15%.
To benefit from the Treaty’s reduced rate of 15%, an individual or entity must provide the depositary with a certificate from the U.S. Internal Revenue Service, or IRS, stating that, to the knowledge of the IRS, it is a resident of the United States within the meaning of the Treaty. The IRS certificate may be obtained by filing an IRS Form 8802 and is valid for a period of one year from the date of issue, unless it includes a specific year for which a tax resident is considered, in which case the certificate will be deemed applicable during that year.
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According to the Order of April 13, 2000, to get a direct application of the Treaty’s reduced rate of 15%, the certificate referred to above must be provided to the depositary before the tenth day following the end of the month in which the dividends were distributable by us. If an individual or entity fails to timely provide the depositary with the required documentation, it may obtain a refund of the 4% in excess withholding that would result from the Spanish tax authorities in accordance with the procedures below.
Spanish Refund Procedure
According to Royal Decree 1776/2004, of July 30, 2004, as amended, which further develops the Royal Legislative Decree 5/2004 on the Non-Resident Income Tax Law, a refund of the amount withheld in excess of the rate provided by the Treaty can be obtained from the relevant Spanish tax authorities. An eligible U.S. Holder may pursue the refund claim by filing all of the following:
The Spanish Revenue Office must make the refund within six months after the refund claim is filed. If such period lapses without receipt of the refund, the holder is entitled to receive interest for late payment on the amount of the refund claimed.
The refund claim must be filed within four years of the date on which the withheld tax was collected by the Spanish tax authorities. According to Order EHA/3316, of December 17, 2010, for dividends paid as of January 2011, the 210 Form must be filed as from February 1st of the calendar year following the year in which the dividend was paid.
Individuals and entities are urged to consult their own tax advisers regarding refund procedures and any U.S. tax implications of refund procedures.
Taxation of Capital Gains
Under Spanish law, any capital gains derived from securities issued by persons residing in Spain for tax purposes are considered to be Spanish source income and, therefore, are taxable in Spain. For U.S. residents, income from the sale of ADSs or shares will be treated as capital gains for Spanish tax purposes. Spanish Non-Resident Income Tax is levied at a 19% rate on capital gains realized by persons not residing in Spain for tax purposes who are not entitled to the benefit of any applicable treaty for the avoidance of double taxation. Capital gains and losses will be calculated separately for each transaction and losses may not be offset against capital gains.
Notwithstanding the above, capital gains derived from the transfer of shares on an official Spanish secondary securities market by any holder who is a resident of a country that has entered into a treaty for the avoidance of double taxation with Spain containing a clause of “exchange of information” (as defined in Law 36/2006, of November 30, 2006, related to measures to prevent tax fraud) will be exempt from taxation in Spain. In addition, under the Treaty, capital gains realized by an individual or entity upon the disposition of ADSs or shares will not be taxed in Spain. An individual or entity is required to establish that it is entitled to this exemption by providing to the relevant Spanish tax authorities an IRS certificate of residence in the United States, together with the appropriate Spanish 210 tax form, between January 1st and January 20th of the calendar year following the year in which the transfer of shares took place.
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Spanish Wealth Tax
Individuals not resident in Spain for tax purposes who hold shares or ADSs located in Spain are subject to the Spanish wealth tax (Law 19/1991), which imposes a tax on property and rights located in Spain or that can be exercised within the Spanish territory on the last day of any year. The Spanish tax authorities may take the view that all shares of Spanish corporations and all ADSs representing such shares are located in Spain for Spanish tax purposes. If the tax authorities take this view, non-residents of Spain who held shares or ADSs on the last day of any year would be subject to the Spanish wealth tax for such year on the average market value of such shares or ADSs during the last quarter of such year (this average price of listed shares is published in the official State Gazette every year). Law 4/2008 amended the Spanish wealth tax law, introducing a 100% tax rebate and eliminating the obligation to file any form for tax periods starting as of 1 January 2008. However, this 100% tax rebate was temporarily abolished with effect as of the 2011 fiscal year, and since then this situation has been extended every year. From 2021, the abolition of the rebate has been established as indefinite, thus eliminating the need to stipulate extensions. Notwithstanding the above, there is a tax-free allowance of €700,000.
As a result of the above legislation, non-residents of Spain who hold or held shares, ADSs, or other assets or rights located in Spain according to Spanish wealth tax law, on the last day of the year, the combined value of which exceeds €700,000 might be subject to the Spanish wealth tax on that excess amount at marginal rates varying between 0.2% and 3.5% (the highest bracket increased by 1% since 2021), and would be obliged to file the corresponding wealth tax return.
Law 11/2021 amends the Wealth Tax Law to clarify that all non-residents taxpayers (and not only those who are resident in the EU and EEA jurisdictions) are entitled to apply the tax reliefs approved by the Spanish Regions.
Solidarity Tax on Large Fortunes
On December 29, 2022, a new solidarity tax on large fortunes came into force, meant to be supplementary to the wealth tax described above. The new solidarity tax is a direct and personal tax levied on individuals with a net wealth above €3 million as of December 31 of each year. Non-Spanish residents would be subject to this tax only taking into account their Spanish net wealth. This new tax is consistent with the provisions of the Spanish wealth tax in most essential aspects (such as exemptions, taxable and net taxable bases, tax rates and limit on amount of tax payable). The solidarity tax had been designed to be temporary and remain in force for two calendar years (i.e. 2022 and 2023), although the law included a review clause allowing the legislator to assess whether to extend it at the end of the initial period. Following publication of the recent Royal Decree-Law 8/2023, the solidarity tax has been extended indefinitely (with effects starting in 2024), until the wealth tax is revised in the context of the autonomous community finance system. In order to avoid double taxation, the rules applicable to the new solidarity tax allows individuals to deduct amounts already paid as Spanish wealth tax from their total payable solidarity tax
Spanish Inheritance and Gift Taxes
Under Law 29/1987, transfers of shares or ADSs upon death or by gift are subject to Spanish inheritance and gift taxes if the transferee is a resident of Spain for tax purposes, or if the shares or ADSs are located in Spain at the time of gift or death, or the rights attached thereto could be exercised or have to be fulfilled in the Spanish territory, regardless of the residence of the beneficiary. In this regard, the Spanish tax authorities may determine that all shares of Spanish corporations and all ADSs representing such shares are located in Spain for Spanish tax purposes. The applicable tax rate, after applying all relevant factors, ranges between 0% and 81.6% for individuals. Law 11/2021 amends the Gift and Inheritance Tax Law to clarify that all non-residents taxpayers (and not only those who are resident in the EU and EEA jurisdictions) are entitled to apply the tax reliefs approved by the Spanish Regions, following the case-law of the Spanish Supreme Court.
Gifts granted to corporations not resident in Spain are subject to Spanish Non-Resident Income Tax of 19% of the fair market value of the shares as a capital gain. If the donee is a United States corporation, the exclusions available under the Treaty described above in “—Taxation of Capital Gains” will be applicable.
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Expenses of Transfer
Transfers of ADSs or shares will be exempt from any Spanish transfer tax or value-added tax. Additionally, no Spanish stamp tax will be levied on such transfers. The transfer of shares or ADSs may be subject to the Spanish Financial Transaction tax (the “Spanish FTT”). The Spanish law which implements the Spanish FTT (the “FTT Law”) was approved on October 7, 2020, and published in the Spanish Official Gazette (Boletín Oficial del Estado) on October 16, 2020. The Spanish FTT came into force three months after the publication of the FTT Law (i.e., on January 16, 2021) and will charge a 0.2% rate on specific acquisitions of listed shares issued by Spanish companies (including ADSs) whose market capitalization exceeds 1 billion euros (€1 billion) (this may be the case of Grifols), regardless of the jurisdiction of residence of the parties involved in the transaction. Transactions in the primary market (such as a capital increase) are exempt from the Spanish FTT. However, the Spanish FTT will subject other transactions involving the acquisition of shares or ADSs depending on the market capitalization of Grifols. Prospective investors are advised to seek their own professional advice in relation to the Spanish FTT.
United States Federal Income Tax Considerations
U.S. Holders
Under the United States federal income tax laws, and subject to the passive foreign investment company (“PFIC”) rules discussed below, if you are a U.S. Holder, the gross amount of any dividend (including any preferred dividends on our Class B shares) we pay out of our current or accumulated earnings and profits (as determined for United States federal income tax purposes) is subject to United States federal income taxation. If you are a noncorporate U.S. Holder, dividends (including any preferred dividends on our Class B shares) paid to you that constitute qualified dividend income will be taxable to you at a maximum tax rate of 20%, provided that you hold the shares or ADSs for more than 60 days during the 121-day period beginning 60 days before the ex-dividend date and meet other holding period requirements. Dividends we pay (including any preferred dividends on our Class B shares) with respect to the shares or ADSs generally will be qualified dividend income.
With respect to any dividends we pay (including any preferred dividends on our Class B shares) you must include any Spanish tax withheld from the dividend payment in the gross amount of such dividend even though you do not in fact receive it. Dividends are taxable to you when you, in the case of shares, or the Depositary, in the case of ADSs, receive such dividends, actually or constructively. Such dividends will not be eligible for the dividends-received deduction generally allowed to United States corporations in respect of dividends received from other United States corporations. The amount of a dividend distribution that you must include in your income as a U.S. Holder will be the U.S. dollar value of the euro payments made, determined at the spot euro/U.S. dollar rate on the date the dividend distribution is includible in your income, regardless of whether the payment is in fact converted into U.S. dollars. Generally, any gain or loss resulting from currency exchange fluctuations during the period from the date you include a dividend payment in income to the date you convert the payment into U.S. dollars will be treated as ordinary income or loss and will not be eligible for the special tax rate applicable to qualified dividend income. The gain or loss generally will be income or loss from sources within the United States for foreign tax credit limitation purposes. Distributions in excess of current and accumulated earnings and profits, as determined for United States federal income tax purposes, will be treated as a non-taxable return of capital to the extent of your adjusted tax basis in the shares or ADSs and, thereafter, as capital gain.
Subject to certain limitations, the Spanish tax withheld in accordance with the Treaty and paid over to Spain will be creditable or deductible against your United States federal income tax liability. Special rules apply in determining the foreign tax credit limitation with respect to dividends that are subject to the maximum 20% tax rate. To the extent a refund of the tax withheld is available to you under Spanish law or under the Treaty, the amount of tax withheld that is refundable will not be eligible for credit against your United States federal income tax liability. See “—Spanish Tax Considerations—Spanish Refund Procedure” above for the procedures for obtaining a tax refund.
Dividends will be income from sources outside the United States, and dividends paid will, depending on your circumstances, be “passive” or “general” income which, in either case, is treated separately from other types of income for purposes of computing the foreign tax credit allowable to you.
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A U.S. Holder may make an election to treat all foreign taxes paid as deductible expenses in computing taxable income, rather than as a credit against tax, subject to generally applicable limitations. Such an election, once made, applies to all foreign taxes paid for the taxable year subject to the election. The rules governing foreign tax credits are complex and, therefore, U.S. Holders are strongly encouraged to consult their own tax advisors to determine whether they are subject to any special rules that may limit their ability to make effective use of foreign tax credits and whether or not an election would be appropriate based on their particular circumstances.
Non-U.S. Holders
If you are a non-U.S. Holder, dividends (including any preferred dividends on our Class B shares) paid to you in respect of shares or ADSs will not be subject to United States federal income tax unless such dividends are “effectively connected” with your conduct of a trade or business within the United States, and such dividends are attributable to a permanent establishment that you maintain in the United States if that is required by an applicable income tax treaty as a condition for subjecting you to United States taxation on a net income basis. In such cases you generally will be taxed in the same manner as a U.S. Holder. If you are a corporate non-U.S. Holder, “effectively connected” dividends may, under certain circumstances, be subject to an additional “branch profits tax” at a 30% rate or at a lower rate if you are eligible for the benefits of an income tax treaty that provides for a lower rate.
Subject to the PFIC rules discussed below, if you are a U.S. Holder and you sell or otherwise dispose of your shares or ADSs, you will recognize capital gain or loss for United States federal income tax purposes equal to the difference between the U.S. dollar value of the amount that you realize and your adjusted tax basis, determined in U.S. dollars, in your shares or ADSs. Capital gain of a noncorporate U.S. Holder is generally taxed at a maximum rate of 20% where such noncorporate U.S. Holder has a holding period greater than one year. Such gain or loss will generally be income or loss from sources within the United States for foreign tax credit limitation purposes.
If you are a non-U.S. Holder, you will not be subject to United States federal income tax on gain recognized on the sale or other disposition of your shares or ADSs unless:
If you are a corporate non-U.S. Holder, “effectively connected” gains that you recognize may also, under certain circumstances, be subject to an additional “branch profits tax” at a 30% rate or at a lower rate if you are eligible for the benefits of an income tax treaty that provides for a lower rate.
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Passive Foreign Investment Company Considerations
We believe that our shares and ADSs should not be treated as stock of a PFIC for United States federal income tax purposes, but this conclusion is a factual determination that is made annually and, thus, may be subject to change. If we were to be treated as a PFIC, gain realized on the sale or other disposition of your shares or ADSs would in general not be treated as capital gain. Instead, if you are a U.S. Holder, you would be treated as if you had realized such gain and certain “excess distributions” ratably over your holding period for the shares or ADSs and would be taxed at the highest tax rate in effect for each such year to which the gain was allocated, together with an interest charge in respect of the tax attributable to each such year. With certain exceptions, your shares or ADSs will be treated as stock in a PFIC if we were a PFIC at any time during your holding period in your shares or ADSs. Certain elections (such as the mark-to-market election or the qualified electing fund (“QEF”) election) may be available that would result in alternative treatments of the ADSs or shares. Dividends that you receive from us will not be eligible for the special tax rates applicable to qualified dividend income if we are treated as a PFIC with respect to you either in the taxable year of the distribution or the preceding taxable year, but instead will be taxable at rates applicable to ordinary income.
Medicare Contribution Tax on Unearned Income
A U.S. Holder that is an individual is subject to a 3.8% tax on the lesser of (1) such U.S. Holder’s “net investment income” for the relevant taxable year and (2) the excess of such U.S. Holder’s modified adjusted gross income for the taxable year over a certain threshold (between $125,000 and $250,000, depending on the individual’s circumstances). A U.S. Holder that is an estate, or a trust that does not fall into a special class of trusts that is exempt from such tax, is subject to a 3.8% tax on the lesser of (1) such U.S. Holder’s undistributed “net investment income” for the relevant taxable year and (2) the excess of such U.S. Holder’s adjusted gross income for the taxable year over the amount at which the highest tax bracket begins for that taxable year ($15,650 for 2025 and $16,000 for 2026). A U.S. Holder’s net investment income will generally include, among other items, the amount of gross dividend income and the amount of any net gains from such U.S. Holder’s disposition of your shares or ADSs, unless such dividends or net gains are derived in the ordinary course of the conduct of a trade or business (other than a trade or business that consists of certain passive or trading activities). U.S. Holders that are individuals, estates or trusts should consult their own tax advisors regarding the applicability of this tax to income and gains in respect of their investment in the shares or ADSs.
Backup Withholding and Information Reporting
If you are a noncorporate U.S. Holder, information reporting requirements, on Internal Revenue Service Form 1099, generally will apply to:
Additionally, backup withholding may apply to such payments if you are a noncorporate U.S. Holder that:
If you are a non-U.S. Holder, you are generally exempt from backup withholding and information reporting requirements with respect to:
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Payment of the proceeds from the sale of shares or ADSs effected at a foreign office of a broker generally will not be subject to information reporting or backup withholding. However, a sale of shares or ADSs that is effected at a foreign office of a broker will be subject to information reporting and backup withholding if:
In addition, a sale of shares or ADSs effected at a foreign office of a broker will be subject to information reporting if the broker is:
Backup withholding is not an additional tax. You generally may obtain a refund of any amounts withheld under the backup withholding rules that exceed your income tax liability by filing a refund claim with the United States Internal Revenue Service.
Disclosure of Information with Respect to Foreign Financial Assets
Certain U.S. individuals (and certain entities) who hold any interest in “specified foreign financial assets,” including our shares or ADSs, during such holder’s taxable year must attach to their U.S. tax return for such year certain information with respect to each such asset if the aggregate value of all of such assets exceeds $50,000 (or a higher dollar amount prescribed by the Internal Revenue Service), unless such shares or ADSs are held in an account maintained by a U.S. payor, such as a U.S. financial institution or the U.S. branch of a foreign bank or insurer. For this purpose, a “specified foreign financial asset” includes any depositary, custodial or other financial account maintained by a foreign financial institution, and certain assets that are not held in an account maintained by a financial institution, including any stock or security issued by a person other than a U.S. person. A taxpayer subject to these rules who fails to furnish the required information may be subject to a penalty of $10,000, and an additional penalty may apply if the failure continues for more than 90 days after the taxpayer is notified of such failure by the Internal Revenue Service, unless the taxpayer demonstrates a reasonable cause for such failure to comply. An accuracy-related penalty of 40% is imposed for an underpayment of tax that is attributable to an “undisclosed foreign financial asset understatement,” which for this purpose is the portion of the understatement of gross income for any taxable year that is attributable to any transaction involving an “undisclosed foreign financial asset,” including any asset that is subject to information reporting requirements under these rules, which would include our shares or ADSs if the dollar threshold described above were satisfied. The applicable statute of limitations for assessment of U.S. federal income taxes is extended to six years if a taxpayer omits from gross income more than $5,000 and such omission is attributable to a foreign financial asset as to which reporting is required under the rules described in the preceding paragraph or would be so required if such rules were applied without regard to the dollar threshold or any other exceptions specified by the Internal Revenue Service. In addition, the statute of limitations will be suspended if a taxpayer fails to provide in a timely manner either information with respect to specified foreign financial assets required to be reported or the annual information reports required for holders of PFIC stock, including PFIC stock for which a QEF election is made. You should consult your own tax advisor concerning any obligation you may have to furnish information to the Internal Revenue Service as a result of holding our shares or ADSs.
We are subject to the information requirements of the Exchange Act, except that, as a foreign private issuer, we are not subject to the proxy rules or the short-swing profit disclosure rules of the Exchange Act. In accordance with these information requirements, we file or furnish reports and other information with the SEC. Reports and other information filed or furnished by us with the SEC may be inspected and copied at the public reference facilities maintained by the SEC at Room 1024, 100 F Street, N.E., Washington, D.C. 20549, and at the SEC’s regional offices at 233 Broadway, New York, New York 10279 and Northwestern Atrium Center, 500 West Madison Street, Suite 1400, Chicago, Illinois 60661-2511.
Copies of such material may also be inspected at the offices of NASDAQ, 4 Times Square, New York, New York 10036, on which our ADSs are listed. In addition, information filed electronically with the SEC is publicly available on the SEC’s website, which does not form part of this annual report on Form 20-F, at http://www.sec.gov.
If we are required to provide an annual report to security holders in response to the requirements of Form 6-K, we will submit the annual report to security holders in electronic format in accordance with the EDGAR Filer Manual.
The risks inherent in our market-sensitive instruments are potential losses that may arise from adverse changes to interest rates, foreign exchange rates and market prices. We are subject to market risk resulting from changes in interest rates because such changes may affect the cost at which we obtain financing. We are subject to exchange rate risk with respect to our debt denominated in foreign currencies.
See Note 30 to our audited consolidated financial statements included in this annual report on Form 20-F.
Currency Risk
We operate internationally and are exposed to currency risks when operating in foreign currencies, in particular with respect to the U.S. dollar. Currency risk is associated with future commercial transactions, recognized assets and liabilities and net investments in foreign operations.
We hold several investments in foreign operations, the net assets of which are exposed to currency risk. Currency risk affecting net assets of our foreign operations in U.S. dollars are mitigated primarily through borrowings in the relevant foreign currency. Our main exposure to currency risk is to the U.S. dollar, which is used in a significant percentage of our transactions in foreign currencies.
If the U.S. dollar had strengthened by 10% against the euro at December 31, 2025, equity would have increased by €723 million (€1.0 billion at December 31, 2024), and profit would have increased by €97 million (decreased by €27 million at December 31, 2024). This analysis assumes that all other variables are held constant, especially that interest rates remain constant. A 10% weakening of the U.S. dollar against the euro at December 31, 2025 and December 31, 2024 would have had the opposite effect for the amounts shown above, all other variables being held constant.
We use hedge accounting to partially hedge our currency risk exposure. See Note 30(c) to our audited consolidated financial statements included in this annual report on Form 20-F.
Interest Rate Risk
Our interest rate risks arise from current and non-current borrowings. Borrowings at variable interest rates expose us to cash flow interest rate risks. The purpose of managing interest rate risk is to balance the debt structure, maintaining part of borrowings at fixed rates and hedging part of variable rate debt.
As of December 31, 2025, our variable-rate (SOFR and EURIBOR) debt represented 27.0% of our total debt (29.0% at December 31, 2024) and includes mainly senior secured debt. See Item 3 of this Part I, “Key Information—D. Risk Factors—Risks Relating to the Company and Our Business—We are susceptible to interest rate variations.” See also Notes 19, 30(c) and 31 to our to our audited consolidated financial statements included in this annual report on Form 20-F
As of the date of this annual report, we are not participating in interest rate hedges of Euros or U.S. dollars. In previous years, the fair value of interest rate swaps, contracted to reduce the impact of increases in variable interest rates (SOFR and EURIBOR), were accounted for on a monthly basis. These derivative financial instruments comply with hedge accounting requirements.
If the interest rate had been 100 basis points higher at December 31, 2025, the interest expense would have increased by €22 million. A 100 basis points decrease in interest rates at December 31, 2025 would have had the opposite effect for the amounts shown above. As we do not have any hedging derivatives in place, the net effect on cash interest payments would have increased by the same amount.
Market Price Risk
We are subject to price risk with respect to raw materials, which is mitigated by the vertical integration of the hemoderivatives business in a sector that is highly concentrated.
Deutsche Bank Trust Company Americas serves as the depositary for both our Class A ADSs and our Class B ADSs, and its principal executive office is located at 60 Wall Street, New York, NY 10005, USA. The custodian is Deutsche Bank Sociedad Anónima Española, and its principal office in Spain is located at Ronda General Mitre 72-74, 08017 Barcelona, Spain.
Each Class A ADS represents the right to receive one half of one Class A ordinary share of Grifols. Each Class B ADS represents the right to receive one Class B non-voting preference share of Grifols.
The following is a summary of the fee provisions of the deposit agreements for each of the Class A ADSs and Class B ADSs. For more complete information, you should read each deposit agreement in its entirety.
Associated Fee
Depositary Action
$5.00 (or less) per 100 ADSs (or portion of 100 ADSs)
Issuance of ADSs, including issuance resulting from a distribution of shares or rights or other property. Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates.
$2.00 (or less) per 100 ADSs (or portion of 100 ADSs)
Distribution of cash proceeds, including cash dividends or sale of rights and other entitlements.
$2.00 (or less) per 100 ADSs (or portion of 100 ADSs) per calendar year, provided that this fee, when combined with the fee for distribution of cash proceeds, including cash dividends or sale of rights and other entitlements, shall not exceed $2.00 (or less) per 100 ADSs (or portion of 100 ADSs) in any calendar year
Depositary operation and maintenance costs.
Annual fee of $1.00 per 100 ADSs
Inspections of the relevant share register.
Registration or transfer fees
Transfer and registration of our shares on its share register to or from the name of the depositary or its agent when you deposit or withdraw our shares.
Expenses of the depositary
Cable, telex and facsimile transmissions (when expressly provided in the deposit agreement). Converting foreign currency to U.S. dollars.
Taxes and other governmental charges the depositary or the custodian has to pay on any ADS or share underlying an ADS, including any applicable interest and penalties thereon and any share transfer or other taxes or governmental charges, for example, stock transfer taxes, stamp duty or withholding taxes
As necessary.
Any fees and expenses incurred by the depositary in connection with the conversion of a foreign currency in compliance with the applicable exchange control and other regulations, and the delivery of deposited securities, including any fees of a central depository, and any additional fees, charges, costs, or expenses, that may be incurred by the depositary from time to time
Any additional fees, charges, costs or expenses that may be incurred by the depositary from time to time.
The depositary collects its fees for issuance and cancellation of our ADSs directly from investors depositing shares or surrendering our ADSs for the purpose of withdrawal or from intermediaries acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the amounts distributed or by selling a portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services by deduction from cash distributions, by directly billing investors or by charging the book-entry system accounts of participants acting for such investors. The depositary may generally refuse to provide fee-attracting services until its fees for those services are paid.
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The fees and charges holders of our ADSs may be required to pay may vary over time and may be changed by us and by the depositary. Our ADS holders will receive prior notice of such changes.
Fees Paid by the Depositary to Grifols
Deutsche Bank Trust Company Americas, as depositary, has agreed to reimburse or pay on behalf of Grifols certain reasonable expenses related to our ADR programs and incurred by us in connection with the programs, such as investor relations activities and ongoing maintenance expenses and listing fees. It has covered all such expenses incurred by us during 2024 for an amount of $3 million. The amounts the depositary reimbursed or paid are not perforce related to the fees it collected from ADS holders.
“340B Program” means the federal health care program established by Section 340B of the PHS Act, which requires manufacturers participating in Medicaid to agree to provide outpatient drugs to covered entities, including a variety of community health clinics and certain other entities that receive certain governmental health care grants, as well as hospitals that serve a disproportionate share of certain low income individuals, certain cancer centers, children’s hospitals, critical access hospitals and rural referral centers, at significantly reduced prices.
“AAT” means alpha1-antitrypsin, a protein that protects the lungs.
“ACA” refers to the U.S. Affordable Care Act and the companion Healthcare and Education Reconciliation Act, each enacted in March 2010, as amended.
“AMP” means generally the average manufacturer price, as defined based on methodologies set forth in federal regulations, that wholesalers and other large purchasers pay manufacturers for certain outpatient prescription drugs covered by Medicaid, and is used, among other things, to help calculate the rebates paid by certain drug manufacturers that are shared by the U.S. and state governments for Medicaid-covered outpatient drugs.
“albumin” is the most abundant blood plasma protein and is produced in the liver and forms a large proportion of all plasma. Albumin normally constitutes about 60% of human plasma. It is important in regulating blood volume by maintaining the oncotic pressure of the blood compartment.
“ASP” means the average sales price of certain outpatient drugs covered by Medicare Part B, and is used to help calculate reimbursement of such drugs.
“Assays” are systems designed to detect antibodies, antigens or the nucleic acid of an infectious agent. For instance, the WNV assay detects the presence of the West Nile virus in blood donations. The main types of assay used for blood screening are Immunoassays and Nucleic acid technology, or NAT assays.
“ATIII” means intramuscular (hyperimmune) immunoglobulins.
“A1PI” means alpha-1 proteinase inhibitor.
“BLA” (Biologics License Application) is a biological license application issued by the FDA, and serves as a U.S. marketing authorization for certain biological drug products.
“Best Price” means generally the lowest price, as defined based on methodologies set forth in federal regulations, available from a manufacturer for certain outpatient drugs reimbursed by Medicaid, with respect to specified purchasers, such as wholesalers, retailers, health care providers and other designated entities. Best Price is used, among other things, among other things, to help calculate the rebates paid by certain drug manufacturers that are shared by the U.S. and state governments for Medicaid-covered outpatient drugs.
“CCPA” refers to the California Consumer Protection act, a regulation passed by the U.S. state of California.
“CFIUS” refers to the Committee on Foreign Investment in the United States.
“cGMP” means current Good Manufacturing Practice.
“CIDP” means chronic inflammatory demyelinating polyneuropathy, a neurological disease resulting in weakness, numbness, pain and difficulty in walking.
“Cirrhosis” is a medical condition which is a result of advanced liver disease. It is characterized by the replacement of liver tissue by fibrosis (scar tissue) and regenerative nodules (lumps that occur due to attempted repair of damaged tissue).
“Congenital Alpha-1 Antitrypsin Deficiency” is an inherited disease characterized by reduced levels in the blood of the substance Alpha-1 Antitrypsin, or AAT. This substance is a protein that is normally made by the liver and reaches other organs (such as the lungs) after being released into the blood circulation.
“CLL” means chronic lymphocytic leukaemia.
“CMS” refers to the U.S. Centers for Medicare & Medicaid Services.
“CNMV” means the Comisión Nacional del Mercado de Valores.
“CPI-U” means the Consumer Price Index For All Urban Consumers, which measures the changes in the price of a basket of goods and services purchased by urban consumers.
“CPP” is the certificate of pharmaceutical product, a certificate issued in the format recommended by the WHO, which establishes the status of a pharmaceutical product and of the applicant for a certificate in the relevant exporting country.
“Diabetes” is a metabolic disease in which a person has high blood sugar, either because the pancreas does not produce enough insulin, or because cells do not respond to the insulin that is produced.
“DOJ” refers to the United States Department of Justice.
“ELISA” means enzyme-linked immunosorbent assay.
“EMA” refers to the European Medicines Agency.
“Erytra Eflexis” a fully automated, mid-size analyzer that performs pretransfusion compatibility testing using DG Gel technology.
“Factor VIII” or “FVIII” is an essential blood clotting factor also known as anti-haemophilic factor, or AHF. In humans, Factor VIII is encoded by the F8 gene. Defects in this gene results in hemophilia A, which is a sex-linked disease and occurs predominantly in males. FVIII concentrated from donated blood plasma, or alternatively recombinant FVIII, or rFVIII, can be given to hemophiliacs to restore hemostasis.
“Factor IX” is an important blood clotting factor also known as Christmas factor or plasma thromboplastin component, or PTC. It is one of the serine proteases of the coagulation system and belongs to the peptidase family S1. In humans, a deficiency of this protein causes haemophilia B, which is a sex-linked disease and occurs predominantly in males.
“FDA” is the U.S. Food and Drug Administration.
“Fibrin Sealant” is surgical adhesive material that is utilized in a variety of surgical situations.
“Fractionation” is the process of fractionating plasma, or separating it into its different components or plasma derivatives.
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“FSS” refers to the Federal Supply Schedule, a schedule managed by the U.S. Department of Veterans Affairs, which makes available discounted drug pricing for authorized government users.
“GMP” means good manufacturing practices.
“GPO” means group purchasing organization.
“GDPR” refers to the General Data Protection Regulation, an EU regulation.
“Grifols Engineering” means our division of specialists in biopharmaceutical engineering solutions, which develops in-house processes, facilities projects, and specialized machinery for our operations.
“HCV” means hepatitis B virus.
“HBC” means hepatitis C virus.
“Hematology” is the study of blood, blood-forming organs, and blood diseases.
“Hemoderivative” is a substance obtained by fractionation of human blood plasma.
“Hemophilia A” is a genetic deficiency in clotting Factor VIII, which causes increased bleeding (usually affects males).
“Hemostasis” is a complex process which causes the bleeding process to stop. It refers to the process of keeping blood within a damaged blood vessel (the opposite of hemostasis is hemorrhage). Most of the time this includes the changing of blood from a fluid to a solid state. Intact blood vessels are central to moderating blood’s tendency to clot. Hemostasis has three major steps: 1) vasoconstriction, 2) temporary blockage of a break by a platelet plug, and 3) blood coagulation, or formation of a clot that seals the hole until tissue are repaired.
“HHS” refers to the U.S. Department of Health and Human Services.
“HIPAA” refers to the U.S. Health Insurance Portability and Accountability Act of 1996, as amended, and the regulations promulgated thereunder, a U.S. health information privacy, security and breach notification.
“HIV” refers to the human immunodeficiency virus.
“HRSA” means the Health Resources & Services Administration, the subagency of HHS responsible for, among other things, oversight of the 340B Program. HRSA is primarily responsible for ensuring access to health care services for people who are uninsured, including through grant funding programs.
“IG” means immunoglobulin, which contains the pooled IgG (immunoglobulin (antibody) G) extracted from plasma.
“Immunohematology” is a branch of hematology relating to the study of antigens and antibodies and their effects on blood and the relationships between disorders of the blood and the immune system.
“Immunology” is a broad branch of biomedical science that covers the study of all aspects of the immune system in organisms. It deals with the physiological functioning of the immune system in states of both health and disease; malfunctions of the immune system in immunological disorders (autoimmune diseases, hypersensitivities, immune deficiency, transplant rejection); the physical, chemical and physiological characteristics of the components of the immune system in vitro, in situ, and in vivo.
“IND” means investigational new drug application, which is an application that must be accepted by the FDA and in effect prior to certain drug sponsors commencing clinical trials involving human subjects.
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“IRB” refers to institutional review boards, oversight committees that approve and monitor clinical trials to protect the rights and welfare of human subjects.
“ITP” means idiopathic thrombocytopenic purpura.
“IVIG” means intravenous immunoglobulin, which is a blood product administered intravenously. It contains the pooled IgG (immunoglobulin (antibody) G) extracted from plasma. It is mainly used as treatment in four major categories: (i) immune deficiencies, (ii) inflammatory and autoimmune diseases, (iii) neurological diseases and (iv) acute infections.
“Kawasaki disease” is a rare autoimmune disease that mostly affects children and causes inflammation of vessels, fever and rashes. This disease can be treated with IVIG.
“Koate-DVI” is a medication is used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A).
“Medicaid” is a social healthcare program in the United States for individuals with low income and resources.
“Medicare” is a U.S. federal health insurance program for individuals 65 years old and over and certain younger individuals with disabilities.
“Medicare Part B” is a portion of the Medicare program generally which provides fee-for-service reimbursement for medical services such as by physicians and other health care practitioners, and certain outpatient services, equipment, supplies, and certain drugs, including physician-administered drugs and drugs provided in the hospital outpatient setting.
“Medicare Part D” is a portion of the Medicare program generally which includes optional coverage for brand name and generic prescription drugs dispensed to Medicare beneficiaries, generally by retail pharmacies. Like, Medicare Part C, Medicare Part D is offered by private health insurance companies that are contracted with Medicare. Individuals enrolled in Medicare Part D generally can choose to receive benefits through stand-alone prescription drug plans, or through Medicare Part C prescription drug plans that provide integrated medical coverage, including drugs.
“MM” means multiple myeloma.
“MRB” refers to the Market Research Bureau, Inc., an independent market research firm which supplies blood and plasma products industry data on a global level.
“NAT” means nucleic acid testing.
“OIG” is the HHS Office of the Inspector General, which is charged with protecting the integrity of HSS programs, including the Medicare and Medicaid programs.
“Orphan drug” is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease. The assignment of orphan status to a disease and to any drugs developed to treat it is a matter of public policy in many countries, and has resulted in medical breakthroughs that may not have otherwise been achieved due to the economics of drug research and development The Orphan Drug Act (ODA) of January 1983, passed in the United States, with lobbying from the National Organization for Rare Disorders, is meant to encourage pharmaceutical companies to develop drugs for diseases that have a small market. Under the law, companies that develop such a drug (a drug for a disorder affecting fewer than 200,000 people in the United States) may be granted seven years of market exclusivity, and may get clinical trial tax incentives.
“Open Payments Program” imposes new reporting and disclosure requirements for pharmaceutical and medical device manufacturers with regard to payments or other transfers of value made to certain U.S. covered healthcare practitioners, such as physicians, and to academic medical centers, and with regard to certain ownership interests held such practitioners in reporting entities.
“PDUFA” is the Prescription Drug User Fee Act, which levies a user fee on certain human drug applications.
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“Plasma” is the liquid part of the blood. The majority of plasma is composed of water. The remainder is essential proteins and antibodies that help sustain our body’s vital functions. A shortage of any one of these plasma proteins, such as albumin or immunoglobulins, can give rise to one of many life-threatening illnesses.
“Plasmapheresis” is a technique which separates plasma from other blood components, such as red blood cells, platelets, and other cells. These unused blood components are suspended in saline solution and immediately re-injected back into the donor while the plasma collection process is taking place. Because the donor is only providing plasma and not whole blood, the recovery process is faster and better tolerated, and the donor is therefore able to make donations more frequently. Plasmapheresis was developed by Jose Antonio Grifols Lucas in the year 1951. It is the only procedure that is capable of obtaining sufficient quantities of plasma to cover the needs of manufacturing our many different plasma protein therapies.
“Plasma derivatives” are proteins found in human plasma, which once isolated and purified, have therapeutic value.
“PTC” means plasma thromboplastin component.
“Prolastin” is a concentrated form of alpha1-antitrypsin, or AAT, produced by Grifols and derived from human plasma and approved only for chronic, or ongoing, replacement therapy in people with emphysema caused by genetic AAT deficiency. Given as prescribed, Prolastin raises the levels of AAT in the blood and lungs. Raising the AAT level may help reduce the damage to the lungs caused by destructive enzymes.
“Promonitor” Highly specific ELISA kits for quantification of serum drug levels and anti-drug antibodies of various biological drugs
“RNA” means ribonucleic acid.
“sCAP” means severe community acquired pneumonia.
“SCIG” means subcutaneous immune globulin, which is a blood product administered subcutaneously. It contains the pooled IgG (immunoglobulin (antibody) G) extracted from plasma and is mainly used as treatment in four major categories: (i) immune deficiencies, (ii) inflammatory and autoimmune diseases, (iii) neurological diseases and (iv) acute infections.
“SME” means small and medium-sized enterprises.
“SYK-inhibitor” means a new group of small molecule inhibitors which have been proposed as a therapy for both lymphoma and chronic lymphocytic leukemia.
“TMA” means transcription mediated amplification, a technology that allows a clinical laboratory to perform assays for blood screening with fewer steps, less processing time, and faster results. It is used in molecular biology, forensics, and medicine for the rapid identification and diagnosis of pathogenic organisms.
“treatment-naive” means, regarding any person, that such person has never received for a specific condition, drug or therapy.
“Von Willebrand Disease” is the most common hereditary coagulation abnormality described in humans, although it can also be acquired as a result of other medical conditions. It arises from a qualitative or quantitative deficiency of von Willebrand factor, a multimeric protein that is required for platelet adhesion.
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Our Chief Executive Officer (“CEO”) and our Chief Financial Officer (“CFO”), after evaluating the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act) as of the end of the period covered by this Annual Report on Form 20-F, have concluded that, as of such date, our disclosure controls and procedures were effective.
Our management, under the supervision of our CEO and CFO, is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act. Our system of internal control is designed to provide reasonable assurance as to the reliability of financial reporting and the preparation of the published financial statements under generally accepted accounting principles. For Grifols, S.A., “generally accepted accounting principles” means IFRS as issued by the IASB.
Our internal control over the financial reporting includes those policies and procedures that: (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of our company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of our company are being made only in accordance with authorizations of management and directors of our company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our company assets that could have a material effect on the financial statements.
Any system of internal control, no matter how well designed, has inherent limitations, including the possibility of human error and the circumvention or overriding of the controls and procedures, which may not prevent or detect misstatements.
Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2025. Based on our assessment under these criteria, our management determined that, as of December 31, 2025, our internal control over financial reporting was effective.
Remediation of Material Weakness
In the year ended December 31, 2024, we identified a material weakness related to the accounting for complex transactions during the preparation of the consolidated financial statements. These errors resulted in the restatement of the comparative financial information for the years ended December 31, 2023 and 2022 as described in the prior year 20-F filing on April 10, 2025. In particular, the misstatements were the result of a material weakness in the Control Environment component of the Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission, as the Company lacked a sufficient complement of resources related to the accounting for complex transactions requiring significant judgment in the preparation of the consolidated financial statements.
During 2025, we implemented certain changes to improve the control environment related to the accounting of complex transactions requiring significant judgment, including:
As the controls have operated for a sufficient period and management have concluded, through testing, that the controls are operating effectively, management, including our CEO and CFO, has concluded that the material weakness identified in the prior year has been remediated as of December 31, 2025.
Deloitte Auditores, S.L., an independent registered public accounting firm, who also audited the Group’s consolidated financial statements for 2025, has audited the effectiveness of Grifols S. A.’s internal control over financial reporting, and has issued an unqualified opinion thereon, which was included on page F-4 of the annual report on Form 20-F for the fiscal year ended December 31, 2025.
Except for the changes described above, there have been no changes in our internal control over financial reporting that have occurred during the period covered by this Annual Report on Form 20-F, that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.
The Board has determined that Mr. Íñigo Sánchez-Asiaín Mardones is an “audit committee financial expert,” as defined in Item 16A of Form 20-F, and is an independent director under Rule 10A-3 under the Exchange Act.
We have adopted the Employee Code of Conduct, which applies to all of our employees, directors and officers, including our principal executive officer, principal financial officer and principal accounting officer. This Code (available on our website, at www.grifols.com) is intended to meet the definition of “code of ethics” under Item 16B of Form 20-F.
If the Code of Conduct for Grifols’ Employees is amended, or if a waiver is granted, we will disclose such amendment or waiver on our website.
The table below sets forth the total fees paid to Deloitte Auditores, S.L., our principal accountants, or members of the same organization, for services performed in 2025 and 2024:
Audit
Audit-related fees(1)
Audit-related fees include fees for assurance and related services by the principal accountant that are reasonably related to the performance of the audit or review of the registrant’s financial statements, including limited reviews of the interim financial statements and the audit of the financial statements under applicable accounting standards.
The aggregate fees for services for the fiscal year ended December 31, 2025 above do not include €0.4 million in fees for audit-related services performed in connection with an agreement between the Group and a third party. Such fees were invoiced by a member firm of Deloitte Auditores, S.L. and paid by the third party. However, the Group assumed €0.2 million of such fees for the fiscal year ended December 31, 2025.
Pre-approval Policies and Procedures
Subject to shareholder approval of the independent auditor in accordance with Spanish law, the Audit Committee makes recommendations to the Board regarding the appointment, retainer and replacement of the independent auditor. The Audit Committee is also directly responsible for the compensation and oversight of the work of the independent auditor. We have developed a policy regarding the engagement of professional services by our external auditor, in accordance with the Spanish Audit Law and the Sarbanes-Oxley Act of 2002. This policy generally provides that we will not engage our independent auditors to render audit or non-audit services unless the service is specifically approved in advance by the Audit Committee.
In accordance with the pre-approval policy, all audit and permitted non-audit services performed for us by our principal accountants, or any of its affiliates, were approved by the Audit Committee, which concluded that the provision of such services by the independent accountants was compatible with the maintenance of that firm’s independence in the conduct of its auditing functions.
We did not repurchase any of our equity securities during the year ended December 31, 2025.
As of December 31, 2025, we held 3,778,222 Class A shares and 3,201,374 Class B shares in treasury. In 2025, we delivered 166,208 Class A treasury shares to certain employees as compensation under the Restricted Stock Plan and the Long-Term Incentive Plan. See Note 15(d) to our audited consolidated financial statements included in this annual report.
Pursuant to NASDAQ Listing Rules, as a foreign private issuer, we may elect to follow our home country practice in lieu of the corporate governance requirements of the NASDAQ Listing Rule 5600 Series, with the exception of those rules that are required to be followed pursuant to the provisions of NASDAQ Listing Rule 5615(a)(3). We have elected to follow Spanish practices in lieu of the requirements of the NASDAQ Listing Rule 5600 Series to the extent permitted under NASDAQ Listing Rule 5615(a)(3). Set forth below is a summary of the significant differences between the corporate governance practices we follow under Spanish law (as in effect as of December 31, 2025) and those followed by NASDAQ-listed U.S. domestic issuers.
Corporate Governance
Under NASDAQ Listing Rules, a U.S. domestic issuer is required to establish a quorum as specified in its bylaws for any meeting of the holders of common stock, provided, however, that such quorum is not permitted to be less than 33% of the outstanding shares of voting stock. The Articles of Association provide that, on the first call of our general shareholders’ meetings, a duly constituted meeting requires a quorum of at least 25% of our subscribed share capital with voting rights, and, if a quorum is not obtained on the first call, a meeting is validly convened on the second call regardless of the share capital in attendance. However, certain major corporate actions (such as issuing additional ordinary shares, increasing or decreasing our share capital, issuing debt securities, amending the Articles of Association or approving merger transactions) require shareholder approval at a meeting at which at least 50% of our subscribed share capital with voting rights is present or represented on the first call or at least 25% of the share capital with voting rights present or represented on second call. However, when the number of shareholders attending our meeting represents less than 50% of our subscribed share capital with voting rights, resolutions on any of these major corporate actions must be adopted by the affirmative vote of at least two-thirds of the share capital present or represented at such meeting.
In addition, all actions described in Article 6.bis of the Articles of Association, which are considered to affect the economic rights of our Class B shares, must be approved at a shareholders’ meeting by the holders of at least a majority of Class B shares.
Under NASDAQ Listing Rules, U.S. domestic issuers are required to solicit proxies, provide proxy statements for all shareholders’ meetings and provide copies of such proxy materials to NASDAQ. As a foreign private issuer, we are generally exempt from the SEC rules governing the solicitation of shareholder proxies. However, under Spanish law and per the Articles of Association, we are required to publish a calling of the meeting at least one month prior to the date set for each general shareholders’ meeting in at least: (i) the Official Gazette of the Commercial Registry or one of the local newspapers of wide circulation in the province where we are domiciled (currently Barcelona, Spain); (ii) CNMV’s website; and (iii) our website. We distribute a copy of the notice of the meeting and a form of proxy to our U.S. shareholders and also make these materials available through our website in advance of such meeting.
Under NASDAQ Listing Rules, shareholders of U.S. domestic issuers must be given the opportunity to vote on equity compensation plans and material revisions thereto, with limited exceptions set forth in NASDAQ Listing Rules, including an exception for foreign private issuers who follow the laws of their home country. Under Spanish law, equity compensation plans involving the issuance of our securities require prior shareholder approval. Additionally, equity compensation plans in which our officers and employees participate can be approved by the Board without shareholder approval. However, the establishment of equity compensation plans in which members of the Board participate must be authorized in the Articles of Association and requires the shareholders’ prior approval at a shareholders’ meeting.
Under NASDAQ Listing Rules, shareholders of U.S. domestic issuers must approve the issuance of securities when such issuance would result in a change in control of such issuer. Under Spanish law, any issuance of our securities, regardless of whether such issuance would result in a change of control, requires prior shareholder approval.
In Spain, companies with securities listed on a Spanish Stock Exchange are:
Independence of Directors
Pursuant to NASDAQ Listing Rules, a majority of the directors of a listed U.S. company are required to be “independent,” as such term is defined by NASDAQ Listing Rules. As a foreign private issuer, we are exempt from such requirement, and Spanish law does not contain any such requirements.
Spanish law establishes the category of directors and the indispensable requirements to determine their independence. The Board Regulations, consistent with Spanish law, recognize two main categories of directors: (i) executive directors; and (ii) external directors, who can be divided into (a) proprietary directors, (b) independent directors and (c) other external directors who cannot be considered proprietary or independent.
The definition of “independent director,” as set forth by Spanish law, provides that the persons listed below may not be nominated or designated as independent directors.
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The proprietary directors who lose this status as a consequence of the sale of the shareholding by the shareholder they represent, can be reelected as independent directors only when such shareholder has sold the total amount of its shares.
Finally, any member of the Board that owns our shares can be considered independent, as long as the shareholding is not significant and satisfies all the above-mentioned conditions.
We have not determined whether our directors would be considered independent under NASDAQ Listing Rules, except for the three directors who are members of the Audit Committee and as such must meet NASDAQ independence criteria. As of the date of this report, six members of the Board are independent directors in accordance with the Board Regulations and the CNMV Governance Code.
Furthermore, we follow the Spanish Companies Act, which does not, unlike NASDAQ Listing Rules, require independent directors to hold meetings where only such independent directors are present.
For a detailed discussion of the composition, responsibilities and terms of our Audit Committee, see Item 6 of Part I, “Directors, Senior Management and Employees—C. Board Practices—Committees of the Board—Audit Committee.”
Responsibilities and Terms. In accordance with NASDAQ Listing Rules, our Audit Committee is in charge of the appointment, compensation, retention and oversight of the services of any registered public accounting firm engaged for the purpose of preparing and issuing any audit report, or for performing other audit reviews or related services. Notwithstanding the above, Spanish laws provide our shareholders with the authority to appoint and replace the independent auditor at a general shareholders’ meeting.
Independence of the Audit Committee. All of the members of our Audit Committee meet the independence criteria set out in NASDAQ Listing Rules. Subsequent to the entry into force of Law 31/2014 and Law 22/2015, Spanish law requires that (a) the Audit Committee be composed of external directors (the majority of them being independent and one of them being appointed due to his knowledge and experience in accounting or auditing matters) and (b) the chairperson of the Audit Committee is an independent director. For a further discussion regarding the composition of our Audit Committee, see Item 6 of Part I, “Directors, Senior Management and Employees—C. Board Practices—Committees of the Board—Audit Committee.”
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Internal Audit Department. We have an internal audit department responsible for internal audit matters and ensuring the efficiency of the internal audit control process of our different business units. Our internal audit department reports directly to the Audit Committee, supporting the adequate performance of all its functions.
Pursuant to NASDAQ Listing Rules, foreign private issuers are exempt from the requirements regarding independent nominating and compensation committees. Foreign private issuers are permitted to follow their home country corporate governance practice in this respect.
Spanish law requires that all Spanish listed companies have an appointments and remuneration committee comprised of external directors, at least two of whom must be independent, and that the chairperson of the appointments and remuneration committee be an independent director.
Our Appointments and Remuneration Committee is comprised exclusively of external directors. For a detailed discussion of our Appointments and Remuneration Committee, see Item 6 of Part I, “Directors, Senior Management and Employees—C. Board Practices—Committees of the Board—Appointments and Remuneration Committee.”
Internal Code of Conduct on Matters Related to the Securities Market and Business Ethics
Under NASDAQ Listing Rules, we are required to adopt a code of business conduct and ethics applicable to all directors, officers and employees, which must be publicly available. Under Spanish law, listed companies were previously required to have an internal code of conduct on matters related to the securities markets. However, with the entry into force of Royal Legislative Decree 19/2018, of November 23, 2018, on payment services and other urgent financial measures, this obligation has been removed.
Notwithstanding the above, Grifols will continue to apply the internal code of conduct for securities markets that was approved by the Board in its meeting held on October 28, 2016, and which was updated at the Board of Directors’ meeting held on April 10, 2025 in order to prevent insider trading, misconduct, and to control possible conflicts of interest. The Internal Code of Conduct on Matters Related to the Securities Market is included in this annual report as Exhibit 11.1.
Additionally, the Board Regulations set out in detail the directors’ main obligations relating to conflicts of interest concerning business opportunities, use of Grifols’ assets, confidentiality and non-competition. Although not mandatory under Spanish laws, the Board of Directors also approved the Code of Conduct for Grifols Employees. Both the Board Regulations and the Code of Conduct for Grifols Employees, which do not form part of this annual report on Form 20-F, are publicly available at www.grifols.com.
We have policies and procedures in place governing the purchase, sale and other dispositions of our securities by directors, senior management and employees. Our insider trading policy and procedures are included in our Internal Code of Conduct in Matters Relating to The Securities Market that is attached to this annual report as Exhibit 11.1.
Risk Management and Strategy
Cybersecurity risk management is an integral part of our overall enterprise risk management program. Our cybersecurity risk management program is governed by our Cybersecurity Policy, originally approved by our Board of Directors on November 16, 2023 and amended on December 18, 2025 (the “Cybersecurity Policy”) at the proposal of the Audit Committee of the Board. The amended policy reinforces our governance framework and further integrates cybersecurity risk management within our enterprise risk management processes.
The Cybersecurity Policy establishes a systematic, risk-based approach to the identification, assessment and management of cybersecurity risks, including risks associated with third-party service providers and other external partners, and is designed to facilitate coordination across business units and corporate functions in the handling of cybersecurity threats and incidents. This framework takes a risk-based approach to cybersecurity, aligning with internationally recognized frameworks, including NIST (National Institute of Standards and Technology) and ISO 27001, and includes steps for assessing the severity of a cybersecurity threat, identifying the source of a cybersecurity threat, including whether the cybersecurity threat is associated with a third-party service provider, implementing cybersecurity countermeasures and mitigation strategies and, as later explained in greater detail, informing management and our Board of Directors of material cybersecurity threats and incidents.
In 2025, we further reinforced coordination among cybersecurity, business continuity and data protection functions in order to support a more holistic approach to digital resilience and operational continuity. Cyber risks are reviewed on a regular basis and incorporated into our broader enterprise risk management framework. Our Security Operations Center (SOC) and our Incident Response team (IRT) operate 24 hours per day, providing continuous monitoring across our data centers, perimeters, and workstations. The SOC utilizes a Security Information and Event Management (SIEM) system, which processes alerts and enables rapid detection and response of cybersecurity incidents. Additionally, our cyber-intelligence capabilities track emerging threats, allowing for proactive mitigation strategies.
As cyberattacks evolve and become more sophisticated, we have strengthened our prevention and monitorization efforts. During the past few years, we ramped up cybersecurity and information security measures with the aim to ensure an adequate protection of our information and the assets supporting business processes. Our Chief Digital Information Officer (“CDIO”) is tasked with accelerating our companies’ use of digital platforms, data science and new technologies to transform and strengthen critical business activities such as relationships with plasma donors and customers as well as manufacturing operations, the development of new therapeutics and cybersecurity.
Our Cybersecurity Policy establishes the core principles and general framework for reducing the Group’s exposure to cybersecurity threats, protecting digital assets, ensuring business continuity and complying with applicable regulations. The policy focuses on maintaining secure and resilient systems, continuously assessing and mitigating cybersecurity risks, implementing protective measures, and adapting to technological changes. It also ensures effective incident response and regulatory compliance, supports a qualified cybersecurity team, provides training for employees and executives, and fosters collaboration with industry peers and government agencies.
We have adopted security measures in the past few years intended to: (i) ensure end-to-end protection of business processes, considering logical and physical security, privacy and fraud management concerns, (ii) ensure compliance with the security and privacy by design principles; and (iii) improve client access control and authentication services related to online services, from a security and user experience perspective. Our commitment to cybersecurity is underscored by our ISO 27001 certification, reflecting our adherence to the highest standards of data security.
To safeguard our digital infrastructure, we employ network segregation strategies, including enabled firewalls that isolate instruments from broader networks, permitting only authorized data streams. Our diagnostic systems utilize application whitelisting to block malware and ensure system integrity. Additionally, we encrypt connections and communications across information systems to maintain data confidentiality during transmission, using for instance Virtual Private Networks (VPN). We enforce stringent user access controls, ensuring that personnel access only the data necessary for their roles. In our product development, we integrate advanced cybersecurity measures to ensure that sensitive data is securely protected. This commitment extends to our diagnostic solutions, which are designed with features to provide peace of mind to our clients and stakeholders.
Our approach includes continuous identification and assessment of cybersecurity risks that are thoroughly analyzed to determine the possible impact present and future. Third-party evaluations are conducted as part of the architecture and services evolution. We regularly engage multiple service providers to perform periodic reviews and evaluations of our cybersecurity posture. We share the results to the IT and the Executive committee as part of the regular updates. These reviews encompass a broad range of areas, including but not limited to information technology system resilience, cybersecurity risk assessments, information security program assessments, external threat environment reviews, internal cybersecurity policy compliance, and near-term incident response to identify or disconfirm potential involvement of a threat actor. We maintain a highly qualified cybersecurity team comprising management, information technology, and legal experts.
In addition, SOC operation and incident response teams are delivered by top companies in the cybersecurity sector to ensure that the most appropriate profiles with deep knowledge in cybersecurity are available with the right capacity to handle the activities such as incident management, prioritization and incident resolution. When categorizing incidents, factors such as impact, number of users affected, type of information compromised, the threat actor involved, and sector trends are taken into consideration. Additionally, incidents are reviewed monthly in follow-up meetings with the vendor, shared in weekly IT committee sessions and discussed monthly in the cybersecurity council. Regular training programs for employees, executives, and directors are conducted to heighten awareness of cybersecurity risks and the importance of protecting sensitive and personal data.
In alignment with our continuous improvement commitment, we continue the execution of our Cybersecurity Director Plan for the period 2025-2027. This plan sets a comprehensive approach to advancing our cybersecurity maturity.
The plan presented in the Board of Directors meeting on December 17, 2024, outlines the primary action lines, categorized according to the domains established by the Spanish National Institute of Standards and Technology (“NIST”): governance, identification, protection, detection, response and recovery.
In addition, we continuously carry out training and awareness initiatives related to security and privacy, promoting training and awareness campaigns for our employees. Some of the topics covered include protection of personal information, secure password management, device protection (laptops, smartphones, etc.), social engineering (phishing, smishing, vishing), malware and other technical attacks detection, detection of scams, security on online purchases and how to react if there is a security incident.
As of the date of this annual report on Form 20-F, we have not identified any cybersecurity threats, including as a result of any previous cybersecurity incident, that materially affected or are reasonably likely to materially affect our business strategy, results of operations or financial condition. However, despite our efforts, we cannot eliminate all risks from cybersecurity threats, or provide assurances that we have not experienced an undetected cybersecurity incident. For more information about these risks, please see Item 3 of Part I, “D. Risk Factors—Risks Relating to the Company and Our Business—Cyber-attacks or other privacy and data security incidents could disrupt our business and expose us to significant losses, liability and reputational damage.”
Governance
Our Board of Directors, through the Audit Committee, is responsible for supervising and evaluating the efficiency of the control and management on cybersecurity. Our Internal Audit and Enterprise Risk Management Department supports the Audit Committee in the fulfilment of this responsibility, which includes oversight of our threat landscape, posture, performance, and strategy related to cybersecurity. The Audit Committee oversees cybersecurity incident trends and material incidents and receives periodic updates regarding cybersecurity posture, risk exposure, mitigation initiatives and incident response activities. In the event of an incident with impact, the Head of the Information Security Office would contact the Chief Digital and Information officer who will liaise with the relevant parties in the Executive Committee and Internal Audit to present the incident and impact. The same audience will be updated regularly about the root cause, and countermeasures implemented in addition to the upcoming audit committee meeting.
202
To support the deployment of the principles of our cybersecurity strategy and processes, we have created and implemented the Information Security Process and Management System (the “ISMS”). The ISMS is based on the appropriate definition of objectives, roles and responsibilities, policies and procedures, and technology to: (i) identify cybersecurity threats and related risks; (ii) protect critical assets; (iii) detect and respond to cybersecurity threats and cybersecurity incidents; and (iv) recover business services due to a cybersecurity incident.
Our Head of the Information Security Office (“ISEC”) reports to the CDIO and has the authority to develop and implement our cybersecurity policies, standards, procedures, and oversee the implementation and effectiveness of the ISMS. Our Head of the ISEC has more than 20 years of experience in cybersecurity practice, having worked for five years in the risk management practice of a global consulting firm, and for five years as global Chief Information Security Officer for a multinational company. He is a Telecommunication Engineer and has been awarded with CISA and PMP certifications, among others. He is also member of the ISMS forum (La Asociación Española para el Fomento de la Seguridad de la Información), in Spain and participates in roundtables and industry forums to stay connected to the latest cybersecurity trends. Our Chief Digital information officer has more than 25 years of experience working across multiple sectors for top 100 fortune companies such as IBM, Procter and Gamble, HP and Deutsche Post DHL.
In 2025, we strengthened the role of our Global Cybersecurity Committee, a cross-functional body composed of representatives from business units, information technology, legal, operations and services, which supports alignment of cybersecurity initiatives with business objectives and promotes a cybersecurity culture across the organization. This committee facilitates the alignment of cybersecurity initiatives with business objectives; ensure global coverage of the ISMS; collaborates in the prioritization and execution of security initiatives and projects; and promotes a culture of protection against cybersecurity threats throughout the Grifols Group entities. This committee is comprised of representatives of business units, information technology and legal personnel, as well as operations and services areas.
In addition to periodic meetings with representatives from various areas, including lawyers, accountants and information technology specialists, as well as a continually open line of communications, the Head of Internal Audit shall attend together with the Head of the ISEC and the CDIO to update the Audit Committee at least once per quarter regarding the control and management on cybersecurity.
203
We have elected to provide financial statements pursuant to Item 18 of this Part III.
The audited consolidated financial statements as required under Item 18 of this Part III are attached hereto starting on page F-1 of this annual report on Form 20-F. The audit report of Deloitte Auditores, S.L., our independent registered public accounting firm, is included herein preceding the audited consolidated financial statements.
ExhibitNumber
Description
1.1
Articles of Association (Estatutos Sociales) of Grifols, S.A. (English translation) (incorporated herein by reference to Exhibit 1.1 to our Annual Report on Form 20-F (File No. 001-35193) filed on April 11, 2025)
Amendment No. 1 to Deposit Agreement dated as of March 14, 2011 among Grifols, S.A., Deutsche Bank Trust Company Americas, as depositary, and all Holders from time to time of American Depositary Shares evidenced by American Depositary Receipts issued thereunder (incorporated herein by reference to Exhibit (a)(2) to our Registration Statement on Form F-6 (File No. 333-182636) filed on July 12, 2012)
2.2
Amendment No. 2 to Deposit Agreement dated as of December 30, 2020 among Grifols, S.A., Deutsche Bank Trust Company Americas, as depositary, and all Holders and Beneficial Owners of American Depositary Shares evidenced by American Depositary Receipts issued thereunder (incorporated herein by reference to Exhibit 2.2 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 9, 2021)
Form of Deposit Agreement among Grifols, S.A., Deutsche Bank Trust Company Americas, as depositary, and all Holders from time to time of American Depositary Shares evidenced by American Depositary Receipts issued thereunder (incorporated herein by reference to Exhibit (a) to our Registration Statement on Form F-6 (File No. 333-172688) filed on March 9, 2011)
Form of Deposit Agreement among Grifols, S.A., Deutsche Bank Trust Company Americas, as depositary, and all Holders from time to time of American Depositary Shares evidenced by American Depositary Receipts issued thereunder (incorporated herein by reference to Exhibit (a) to our Registration Statement on Form F-6 (File No. 333-159327) filed on May 18, 2009)
2.5
Senior Notes Indenture, dated as of October 5, 2021, relating to the 3.875% Senior Notes due 2028 and the 4.750% Senior Notes due 2028, between Grifols Escrow Issuer, S.A.U., Grifols S.A., the guarantors signatory thereto and BNY Mellon Corporate Trustee Services Limited, as trustee (incorporated herein by reference to Exhibit 2.9 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 29, 2022)
Form of dollar 4.750% Senior Note due 2028 (incorporated herein by reference to Exhibit 2.9 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 29, 2022)
Form of euro 3.875% Senior Note due 2028 (incorporated herein by reference to Exhibit 2.9 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 29, 2022)
2.6
Supplemental Indenture, dated as of April 21, 2022, relating to the 3.875% Senior Notes due 2028 and the 4.750% Senior Notes due 2028, between Grifols S.A., Grifols Escrow Issuer, S.A.U., the guarantors party thereto and BNY Mellon Corporate Trustee Services Limited, as trustee (incorporated herein by reference to Exhibit 2.14 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 18, 2023)
2.7
Supplemental Indenture, dated as of September 28, 2022, relating to the 3.875% Senior Notes due 2028 and the 4.750% Senior Notes due 2028, between Grifols Escrow Issuer, S.A.U., Grifols Biotest Holdings GmbH and BNY Mellon Corporate Trustee Services Limited, as trustee (incorporated herein by reference to Exhibit 2.15 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 18, 2023)
Supplemental Indenture, dated as of July 21, 2023, relating to the 3.875% Senior Notes due 2028 and the 4.750% Senior Notes due 2028, between Grifols S.A., the guarantors party thereto and BNY Mellon Corporate Trustee Services Limited, as trustee (incorporated herein by reference to Exhibit 2.14 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 19, 2024)
Supplemental Indenture, dated as of April 14, 2026, relating to the 3.875% Senior Notes due 2028 and the 4.750% Senior Notes due 2028, between Grifols S.A., the guarantors party thereto and BNY Mellon Corporate Trustee Services Limited, as trustee*
2.10
Senior Notes Indenture, dated as of April 30, 2024, relating to the 7.500% Senior Secured Notes due 2030, between Grifols S.A., the guarantors signatory thereto and BNY Mellon Corporate Trustee Services Limited, as trustee (incorporated herein by reference to Exhibit 2.14 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 11, 2025)
Form of 7.500% Senior Secured Note due 2030 (File No. 001-35193) filed on April 11, 2025)
2.11
Supplemental Indenture, dated as of June 4, 2024, relating to the 7.500% Senior Secured Notes due 2030, between Grifols S.A., the guarantors party thereto and BNY Mellon Corporate Trustee Services Limited, as trustee (incorporated herein by reference to Exhibit 2.15 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 11, 2025)
2.12
Supplemental Indenture, dated as of November 13, 2025, relating to the 7.500% Senior Secured Notes due 2030, between Grifols S.A., the guarantors party thereto and BNY Mellon Corporate Trustee Services Limited, as trustee*
2.13
Supplemental Indenture, dated as of April 14, 2026, relating to the 7.500% Senior Secured Notes due 2030, between Grifols S.A., the guarantors party thereto and BNY Mellon Corporate Trustee Services Limited, as trustee*
2.14
Senior Notes Indenture, dated as of December 19, 2024, relating to the 7.125% Senior Secured Notes due 2030, between Grifols S.A., the guarantors signatory thereto and BNY Mellon Corporate Trustee Services Limited, as trustee (incorporated herein by reference to Exhibit 2.16 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 11, 2025)
Form of 7.125% Senior Secured Note due 2030 (incorporated herein by reference to Exhibit 2.16 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 11, 2025)
2.15
Supplemental Indenture, dated as of April 14, 2026, relating to the 7.125% Senior Secured Notes due 2030, between Grifols S.A., the guarantors party thereto and BNY Mellon Corporate Trustee Services Limited, as trustee*
Credit Agreement, dated as of April 14, 2026 by and among Grifols International Services Designated Activity Company and Grifols International Services USA Inc., as Borrowers, Grifols, S.A. and certain subsidiaries of Grifols, S.A., as guarantors, the lenders party thereto and Bank of America, N.A., as administrative and collateral agent *
4.2
Description of Securities (incorporated herein by reference to Exhibit 4.7 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 9, 2021)
Plasma Supply Agreement, dated as of February 5, 2019, among Grifols, S.A., Grifols Worldwide Operations Limited, Biotest Pharmaceuticals Corporation and Haema GmbH (incorporated herein by reference to Exhibit 10.1 of our Annual Report on Form 20-F/A (File No. 001-35193) filed on April 23, 2019)
205
8.1
List of subsidiaries (see Notes 1 and 2(b) to our audited consolidated financial statements starting on page F-1 of this annual report on Form 20-F)*
10.1
Notices sent to directors and executive officers concerning equity securities subject to blackout periods*
11.1
Internal Code of Conduct of Grifols, S.A. in Matters Relating to the Securities Market*
12.1
Principal Executive Officer Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
12.2
Principal Financial Officer Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*
13.1
Principal Executive Officer and Principal Financial Officer Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*
97.1
Executive Compensation Clawback Policy (incorporated herein by reference to Exhibit 97.1 of our Annual Report on Form 20-F (File No. 001-35193) filed on April 19, 2024)
Interactive Data File
101.INS
Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
101.SCH
Inline XBRL Taxonomy Extension Schema
101.CAL
Inline XBRL Taxonomy Extension Schema Calculation Linkbase
101.DEF
Inline XBRL Taxonomy Extension Schema Definition Linkbase
101.LAB
Inline XBRL Taxonomy Extension Schema Label Linkbase
101.PRE
Inline XBRL Taxonomy Extension Schema Presentation Linkbase
Cover Page Interactive Date File (formatted as Inline XBRL and contained in Exhibit 101)
Filed herewith.
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report on its behalf.
By:
/s/ José Ignacio Abia Buenache
Name: José Ignacio Abia Buenache
Title: Chief Executive Officer of the Board of Directors
Date: April 17, 2026.
GRIFOLS, S.A. AND SUBSIDIARIES
Consolidated Financial Statements
31 December 2025 and 2024
●
Consolidated Annual Accounts
F - 2
F - 3
F - 6
F - 8
F - 9
F - 10
F - 11
Notes
Nature, Principal Activities and Subsidiaries
F - 12
Basis of Presentation
Business Combinations and Divestments
F - 23
(4)
Significant Accounting Policies
F - 26
(5)
Segment Reporting
F - 43
Goodwill
F - 48
(7)
Other Intangible Assets
F - 56
Leases
F - 58
F - 60
Equity-Accounted Investees and Joint Business
F - 61
(11)
Financial Assets
F - 68
(12)
Inventories
F - 70
(13)
Trade and Other Receivables
F - 71
Cash and Cash Equivalents
F - 73
(15)
Equity
Earnings Per Share
F - 80
(17)
Non-Controlling Interests
F - 81
Provisions
F - 86
(19)
Financial Liabilities
F - 87
(20)
Trade and Other Payables
F - 94
(21)
Other Current Liabilities
F - 95
(22)
Net Revenues
(23)
Personnel Expenses
F - 97
(24)
Expenses by Nature
F - 98
Finance Result
F - 99
(26)
Pension Plans and Other Benefit Plans
Employee Benefits
F - 103
(28)
F - 105
(29)
Other Commitments with Third Parties and Other Contingent Liabilities
F - 111
(30)
Financial Instruments
F - 116
Balances and Transactions with Related Parties
F - 125
(32)
Subsequent events
F - 129
Appendix
Information on Group Companies, Associates and others
F - 131
Accounting statement of results and liquidity
F - 139
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and Board of Directors of Grifols, S.A.:
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated statements of profit and loss, comprehensive income, cash flow, and changes in consolidated equity of Grifols, S.A. and subsidiaries (the Company) for the year ended December 31, 2023, and the related notes and Appendix I (collectively, the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the results of operations of the Company and its cash flows for the year ended December 31, 2023, in conformity with International Financial Reporting Standards Accounting Standards as issued by the International Accounting Standards Board and International Financial Reporting Standards as adopted by the European Union.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. Our audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audit provides a reasonable basis for our opinion.
/s/ KPMG Auditores, S.L.
We served as the Company’s auditor from 1990 to 2023.
April 11, 2025
F-2
To the shareholders and the Board of Directors of Grifols, S.A.,
We have audited the accompanying consolidated balance sheets of Grifols, S.A. and subsidiaries (the “Company”) as of December 31, 2025 and 2024, the related consolidated statements of profit and loss, comprehensive income, changes in consolidated equity, and consolidated cash flows, for each of the two years in the period ended December 31, 2025, and the related notes and Appendices I and II (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2025, in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated April 17, 2026 expressed an unqualified opinion on the Company’s internal control over financial reporting.
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current-period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Evaluation of the Diagnostics CGU (Cash Generating Unit) goodwill impairment analysis
Critical Audit Matter Description
As discussed in Note 6 to the consolidated financial statements, the goodwill balance as of 31 December 2025 amounted to EUR 6,833 million of which EUR 2,525 million related to the Diagnostics cash generating unit (CGU). On an annual basis and whenever there is an impairment indicator, the Company assesses the recoverable amount of goodwill and the net assets associated with each of the CGUs, for which purpose the Company employs cash flow projections aligned with projected earnings and the necessary investments.
F-3
In particular, the Company determines the recoverable amount of goodwill of the Diagnostics CGU based on the fair value less costs to sell using the discounted cash flow (DCF) method. In addition, the Company periodically, for this determination of the recoverable amount, has external valuation reports used to compare the results obtained through their own DCF model, as a benchmark for value.
We identified the evaluation of the goodwill impairment analysis for the Diagnostics CGU as a critical audit matter because significant judgment and an increased extent of audit effort, including the involvement of our valuation specialists, were required to evaluate the Company’s impairment test which was performed using a DCF model. The DCF model included assumptions related to sales and EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization) projections for the Molecular Donor Screening (MDS), Blood Typing Solutions (BTS) and Clinical Diagnostics (CDx) lines of business, perpetual growth rate, and the discount rate. Minor changes to these assumptions could have a significant effect on the Company’s determination of the recoverable amount of the goodwill.
How the Critical Audit Matter Was Addressed in the Audit
Our audit procedures related to management’s assessment of goodwill for impairment included the following, among others:
-
Reasonableness of the methodology employed by the Company in the impairment test, including the verification of the mathematical accuracy of the DCF.
Reasonableness of valuation assumptions, such as the discount rate and perpetual growth rate for the Diagnostics CGU included in the Company’s DCF.
Recoverable amount of the Diagnostics CGU determined by the Company was consistent with recent market valuations and transactions of comparable companies in the industry.
/s/ Deloitte Auditores, S.L.
April 17, 2026
We have served as the Company’s auditor since 2024.
F-4
Opinion on Internal Control over Financial Reporting
We have audited the internal control over financial reporting of Grifols, S.A. and subsidiaries (the “Company”) as of December 31, 2025, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). In our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control — Integrated Framework (2013) issued by COSO.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial statements as of and for the year ended December 31, 2025, of the Company and our report dated April 17, 2026, expressed an unqualified opinion on those financial statements.
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management’s Report on Internal Control over financial reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
F-5
Consolidated Balance Sheets
at 31 December 2025 and 2024
(Expressed in millions of Euros)
Assets
Reference
31/12/2025
31/12/2024
Note 6
6,833
7,403
Other intangible assets
Note 7
2,728
2,926
Rights of use
Note 8
932
968
Property, plant and equipment
Note 9
3,120
3,342
Investment in equity-accounted investees
Note 10
Non-current financial assets measured at fair value
339
423
Non-current financial assets at amortized cost
Total non-current financial assets
Note 11
512
490
Other non-current assets
Deferred tax assets
Note 28
416
342
Total non-current assets
14,638
15,677
Note 12
3,296
3,560
Current contract assets
Note 13
Trade and other receivables
Trade receivables
651
705
Other receivables
Current income tax assets
769
836
Other current financial assets
Current financial assets measured at fair value
Current financial assets at amortized cost
Total current financial assets
244
Other current assets
Cash and cash equivalents
Note 14
825
980
Total current assets
5,074
5,728
Total assets
19,712
21,405
The accompanying notes form an integral part of the consolidated financial statements.
F-6
Equity and liabilities
Share capital
Share premium
911
Reserves
4,185
4,054
Interim dividend
(102)
Treasury stock
(131)
(135)
Profit for the year attributable to the Parent
402
Total shareholder’s equity
5,385
5,107
Cash Flow hedges
Other comprehensive Income
Other comprehensive income from financial instruments valuation
(98)
Translation differences
803
Total Other comprehensive expenses
(114)
776
Equity attributable to the Parent
Note 15
5,271
5,883
Non-controlling interests
Note 17
2,332
2,723
Total equity
7,603
8,606
Liabilities
Grants
Note 18
Non-current financial liabilities
Nota 19
9,091
9,491
Other non-current liabilities
Deferred tax liabilities
Nota 28
861
1,012
Total non-current liabilities
10,090
10,643
Current other financial liabilities
Note 19
552
676
Trade and other payables
Suppliers
841
852
Other payables
252
210
Current income tax liabilities
Total trade and other payables
Note 20
1,118
1,123
Other current liabilities
Note 21
314
318
Total current liabilities
2,019
2,156
Total liabilities
12,109
12,799
Total equity and liabilities
F-7
Consolidated Statements of Profit and Loss
for the years 2025, 2024 and 2023
(Expressed in thousands of Euros)
2023 (*)
Note 5 and 22
Operating Expenses
Other income
Profit of equity accounted investees with similar activity to that of the Group
Operating Result
Financial cost of sale of trade receivables
Note 25
Profit/(loss) of other equity accounted investees
Consolidated net profit attributable to:
Profit attributable to the Parent
Profit attributable to non-controlling interest
Basic earnings per share (Euros)
Note 16
0.59
0.23
0.06
Diluted earnings per share (Euros)
(*) (See Note 2.d)
F-8
Consolidated Statements of Comprehensive Income
(1,052)
515
(304)
Equity accounted investees / Translation differences
(62)
Other comprehensive income from non-current assets held for sale
Cash flow hedges - effective portion of changes in fair value
Cash flow hedges - amounts taken to profit or loss
Total other comprehensive (loss) income recognized for the year that may be reclassified subsequently to profit or loss
(1,056)
493
(363)
Gains (losses) from defined benefit plans
Gains (losses) from financial assets measured at fair value through comprehensive income
(80)
Tax effect
Total other comprehensive income (loss) recognized for the year that will not be reclassified subsequently to profit or loss
(76)
Total Other comprehensive income (loss) for the year
(1,132)
475
(364)
Total comprehensive income (loss) for the year
(632)
688
(201)
Total comprehensive income attributable to the Parent
(488)
526
(278)
Total comprehensive income attributable to non-controlling interests
(144)
F-9
Consolidated Statements of Cash Flows
31 December 2025, 2024 and 2023
Cash flows from operating activities
Adjustments for:
1,148
1,182
1,034
Amortization and depreciation
Note 24
438
446
Other adjustments:
698
744
(Profit) / losses on equity accounted investments
(37)
(63)
Impairment of assets and net provision charges
(Profit) / losses on disposal of fixed assets
Government grants taken to income
Finance cost / (income)
628
681
556
Other adjustments
Change in operating assets and liabilities
Change in inventories
(97)
(411)
Change in trade and other receivables
(69)
Change in current financial assets and other current assets
Change in current trade and other payables
Other cash flows used in operating activities
(685)
(747)
(660)
Interest paid
Note 19(e)
(532)
(571)
Interest received
Income tax paid
(169)
(176)
(159)
Other paid
Net cash from/(used in) operating activities
Cash flows from investing activities
Payments for investments
(588)
(702)
(432)
Group companies, associates and business units
Note 3 and 10
(108)
(286)
Property, plant and equipment and intangible assets
(423)
(372)
(310)
(265)
(233)
(224)
Intangible assets
(158)
(139)
(86)
Other financial assets
Note 11 and 31
(57)
(93)
Proceeds from the sale of investments
1,588
Non-current assets held for sale
1,564
Cash flows from financing activities
Proceeds from and payments for financial liability instruments
(1,352)
Issue
1,360
4,007
1,638
Redemption and repayment
(1,550)
(5,248)
(1,351)
Lease payments
Note 8 and 19(e)
(119)
(111)
(116)
(128)
Dividends paid
Note 15 and 17
Other cash flows used in financing activities
(92)
Financing costs included in the amortized cost of the debt
(58)
Acquisition of non-controlling interests
(129)
Other amounts from / (used in) financing activities
Effect of exchange rate fluctuations on cash
(94)
Net increase / (decrease) in cash and cash equivalents
(155)
Cash and cash equivalents at beginning of the year
529
549
Cash, restricted cash and cash equivalents at year end
F-10
Statement of Changes in Consolidated Equity for the years ended31 December 2025, 2024 and 2023
Attributable to shareholders of the Parent Company
Accumulated other comprehensive income
Equity to
Profit attributable
Other
Other comprehensive
attributable
Share
to
Interim
Treasury
Translation
comprehensive
income from non-current
income from financial
Cash flow
Non-controlling
Capital
Premium
Parent
dividend
Stock
differences
income
assets held for sale
instruments valuation
hedges
interests
Balance at 31 December 2022
3,868
(162)
735
5,672
2,328
8,000
Adjustment (See Note 2.d)
Balance at 31 December 2022 (*)
5,649
7,977
(322)
(366)
Cash flow hedges
Note 30
Other comprehensive income
Other comprehensive income / (expense) for the year
(320)
Profit/(loss) for the year
Total comprehensive income / (expense) for the year
(261)
(184)
Net change in treasury stock
Note 15(d)
Acquisition / Divestment of non-controlling interests
Note 15(c) and 17
Other changes
(260)
(271)
Distribution of 2022 profit:
(185)
Operations with shareholders or owners
(263)
Balance at 31 December 2023
4,041
(153)
413
2,145
7,530
Balance at 31 December 2023 (*)
5,368
7,513
390
496
369
Note 15 (d)
(36)
508
489
Distribution of 2023 profit:
(66)
405
Balance at 31 December 2024
Balance at 31 December 2024 (*)
(813)
(242)
(1,055)
(890)
(110)
(138)
Distribution of 2024 profit:
(157)
(141)
(124)
(371)
Balance at 31 December 2025
F-11
Notes to the Consolidated Financial Statements
(in thousand Euros)
Grifols, S.A. and its subsidiaries (hereinafter, the “Group” or “Grifols”) form an integrated and diversified business group, specialized in the development of plasma-derived medicines (hemoderivatives). Thanks to the collaboration of donors across its global network of donation centers, the Group contributes daily to improving the quality of life of millions of patients with rare and chronic diseases. In addition, Grifols stands out in the field of diagnostic solutions and transfusion medicine, reinforcing the safety of the global blood supply and providing biological materials for research and pharmaceutical manufacturing.
The main manufacturing facilities of the Group’s Spanish companies are located in Parets del Vallès (Barcelona) and Torres de Cotilla (Murcia), while those of its North American companies are located in Los Angeles (California), Clayton (North Carolina), Emeryville (California), and San Diego (California). Additionally, Grifols has plants in Dublin (Ireland), Montreal (Canada), and Dreieich (Germany).
Annex I lists the main companies that make up the Group, as well as their activity, main corporate purpose, registered address, date of incorporation, the Group’s effective ownership percentage, and their consolidation method.
The parent company of the Group is Grifols, S.A. (hereinafter, the “Company”), a public limited company incorporated for an indefinite period in Spain on June 22, 1987. Its registered office and tax address are located at Avinguda de la Generalitat 152-158, 08174 Sant Cugat del Vallès, Barcelona.
The Company’s principal activity consists of providing administration, management and control services to companies and businesses, as well as investing in tangible and intangible assets, mainly in relation to its subsidiary companies.
All of the Company’s shares are listed on the Barcelona, Madrid, Valencia and Bilbao securities markets and on the Spanish Automated Quotation System (SIBE/Continuous Market). Additionally, Class B non-voting shares (ADRs) are listed on the NASDAQ (USA) and on the Spanish Automated Quotation System (SIBE/Continuous Market).
(2)Basis of Presentation
The consolidated annual financial statements have been prepared on the basis of the accounting records of Grifols, S.A. and the entities included in the Group. The consolidated annual financial statements for the year 2025 and the comparative figures have been prepared in accordance with the International Financial Reporting Standards Accounting Standards as issued by the International Accounting Standards Board (IFRS‑IASB), which, for the purposes of the Group, are identical to the International Financial Reporting Standards as adopted by the European Union (EU‑IFRS) to present a true and fair view of the consolidated equity and consolidated financial position of Grifols, S.A. and its subsidiaries as of 31 December 2025, and of the consolidated results of operations, consolidated cash flows and consolidated changes in equity for the financial year then ended.
The Board of Directors of Grifols, S.A. estimate that he consolidated financial statements for fiscal year 2025, which were formulated on April, 16 2026, will be approved by the General Shareholders’ Meeting without any modifications.
The figures set out in these consolidated financial statements are stated in millions Euro, unless indicated otherwise.
These consolidated financial statements for 2025 show comparative figures for 2024 and 2023 from the consolidated statement of profit and loss, consolidated statement of comprehensive income, consolidated statement of changes in equity and consolidated statement of cash flows and their corresponding notes thereto. For the purposes of comparing the consolidated statement of profit and loss for 2025, 2024 and 2023 and the consolidated balance sheet for 2025 and 2024, the effects of the application new standards described in note 2 must be taken into account.
In accordance with the provision of section 357 of the Irish Companies Act 2014, the Company has irrevocably guaranteed all liabilities of an Irish subsidiary undertaking, Grifols Worldwide Operations Limited (Ireland) (see Appendix I), for the financial year ended 31 December 2025 as referred to in subsection 1(b) of that Act, for the purposes of enabling Grifols Worldwide Operations Limited to claim exemption from the requirement to file their own financial statements in Ireland.
F-12
a) Relevant accounting estimates, assumptions and judgments used when applying accounting principles
The preparation of the consolidated financial statements in accordance with International Financial Reporting Standards as adopted by the European Union (EU-IFRS) requires Management to make judgments, estimates and assumptions that affect the application of the Group’s accounting policies and, consequently, the reported amounts of assets, liabilities, income and expenses.
These estimates and assumptions are based on the best information available at the date of preparation of the consolidated financial statements and on the Group’s historical experience, as well as on reasonable expectations regarding the future development of the economic, regulatory, technological and market environment in which the Group operates. However, given the inherently subjective nature of certain estimates, actual results may differ from those estimates, which could have a significant effect on the consolidated financial statements in future periods.
The most relevant accounting estimates and the most significant judgments applied by Management in the preparation of the consolidated financial statements are detailed below.
Critical accounting estimates
The accounting for non-current assets and goodwill requires the application of significant estimates and judgments, both at initial recognition and in subsequent measurement.
In particular, the Group is required to estimate (i) the useful lives of tangible and intangible assets, (ii) the recoverable amount of the non-current assets when there are indicators of impairment and, at least annually in the case of assets with indefinite useful lives and goodwill, (iii) the fair value of the non-current assets recognised in business combinations or in corporate transactions that involve a change of control or significant influence.
The determination of the useful lives of property, plant and equipment and intangible assets is based on the estimation of the period over which such assets are expected to generate economic benefits for the Group. This assessment requires consideration of legal, technological, functional and economic factors, such as:
The Group also assesses whether there are any indicators of impairment for its amortising non-current assets and, when such indicators are identified, estimates the recoverable amount of those assets. When the recoverable amount is lower than the carrying amount, the Group recognises an impairment loss.
In identifying indicators of impairment, the Group considers, among others, the following internal and external factors:
F-13
These factors may affect both the expected amount of future cash flows and the timing of their generation.
In the case of intangible assets with indefinite useful lives, the recoverable amount is determined annually (Note 4(g)).
Goodwill is not amortized and is tested for impairment, at least annually, at the level of the cash-generating units (CGUs) to which it has been allocated.
The determination of the recoverable amount of a CGU primarily requires:
In the pharmaceutical industry, these assumptions are influenced by factors such as the development of the product pipeline, the results of clinical trials, the obtaining of regulatory approvals, the expected commercial life of products, the emergence of substitute products and changes in pricing policies, among others.
Given the inherently uncertain nature of many of the assumptions used, reasonably possible changes in key estimates could give rise to significant impacts on the carrying amounts of these assets in future periods. For this reason, the Group periodically reviews the appropriateness of the assumptions applied and their alignment with the strategic plan approved by Management and with the environment in which it operates. In this regard, sensitivity analyses are presented in the most relevant cases (Note 6).
In business combinations, the Group determines the fair value of the assets acquired and liabilities assumed at the acquisition date.
This process first requires judgment in identifying the assets and liabilities that arise and are recognised at the time of the business combination, such as:
Subsequently, the fair value of the assets and liabilities identified in the business combination is estimated, which involves the use of valuation techniques and the application of relevant assumptions, particularly in relation to:
F-14
These estimates are particularly relevant in the valuation of intangible assets associated with product portfolio, products under development, technologies and commercial relationships, where the assumptions would be significantly affected, among other factors, by the clinical and commercial success of the products, changes in the regulatory and economic environment and the launch of competing products (Notes 3 and 4(a)).
As a result of a corporate transaction – for example, when significant influence is lost but an interest is retained, or when control is obtained over an investment that was previously classified as an associate – the fair value of the retained interest or of the previously held interest must be determined at initial recognition.
When the entity is not listed, the determination of this fair value is performed using valuation techniques such as:
These variables are highly influenced by the future evolution of the economic, competitive, regulatory and technological environment, which implies a significant degree of judgment in their determination.
The Group capitalises development costs when the criteria set out in IAS 38 are met, which requires significant judgment by Management.
The key criteria in this area are the technical feasibility of the product, the Group’s ability to commercially exploit the developments, and the expectation that they will generate sufficient future economic benefits to recover the carrying amount of the capitalised assets (Note 4(d)).
Inventories are measured at the lower of cost and net realisable value. This assessment depends on factors such as:
–
annual regulatory certifications,
commercial and regulatory changes affecting selling prices,
the launch of substitute products by competitors,
the expected evolution of product demand over the next 12 months, and
product life cycles.
Management periodically assesses the recoverability of inventories and records the necessary write-downs when there is evidence of obsolescence or when the carrying amount exceeds net realisable value.
The recognition of deferred tax assets, mainly in respect of tax losses and deductible temporary differences, requires the determination of future taxable profits, the estimation of the timing at which such assets will become deductible and the expected timing of the reversal of deferred tax liabilities. This assessment is based on the Group’s tax planning within the applicable regulatory framework (Note 4(q)).
In addition, the determination of income tax expense requires significant judgment in relation to the interpretation of the tax legislation in force in the different jurisdictions in which the Group operates, assessing the probability that the tax authorities will accept the positions adopted and estimating the amount that, where applicable, should be recognised as a contingent liability (Note 28).
F-15
The Group recognises provisions when there is a present obligation, whether legal or implicit, arising from past events, the settlement of which is probable to require an outflow of resources and can be reliably estimated. The amount of the provision represents the Group’s best estimate of the expenditure required to settle the corresponding obligation.
The determination of this amount involves significant judgment and the use of estimates that take into account:
the best information available at the reporting date, including the assessment of the probability of occurrence of the event,
the opinion of independent experts, where appropriate, and
the evaluation of legal, tax, regulatory or contractual risks.
Due to the uncertainty inherent in these estimates, the actual outflows may differ from the amounts initially recognised (Notes 18 y 29).
The determination of the fair value of certain financial instruments requires the use of valuation techniques that incorporate assumptions relating to observable and unobservable market variables, such as interest rates, foreign exchange rates, volatility and the credit risk of the counterparties. When quoted prices in active markets are not available, these valuations involve a higher degree of estimation and judgment (Notes 29 y 30).
In the case of call options over equity interests, the valuation model is based on the following elements:
fair value of the shares,
exercise price,
risk-free interest rate,
term of the option,
volatility, and
dividend yield.
The Group does not recognise any asset in respect of the valuation of financial instruments corresponding to call options over equity interests, as the amounts are not significant, given the wide range of positive variability in the estimates (Note 29).
These estimates may be affected by changes in market conditions and in the financial environment, among other factors.
The mechanism of chargeback discounts in the United States does not depend solely on the Group’s sales to the wholesale distributor, but also on the type of end customer to whom the wholesaler subsequently sells the product in the United States. Distributors are responsible for applying the chargeback only at the time of sale to the end customer, and the discount percentage varies significantly depending on the category of customer. End customers are grouped into categories with very different discount levels; for example, the governmental customer category generates significantly higher discounts than other categories.
Accordingly, the provision for chargebacks is recognised at the time of sale to the distributor and its estimation is based on historical settlement experience, the applicable contractual terms, the level of inventory held by distributors and the application of different discount levels depending on the expected mix of end customers to whom the distributor will sell the product (Note 4(p)).
Small changes in the assumptions used may have a significant impact on the revenue recognised.
F-16
Key judgments in the application of accounting policies
The determination of whether or not the Group controls an investee requires significant judgment and is not based solely on holding an ownership interest in excess of 50.01%.
For this purpose, the Group analyses factors such as:
existing voting rights that provide a majority in relevant decision-making,
potential voting rights, considering those that are exercisable at the reporting date (Nota 29(c)),
rights arising from contractual arrangements and shareholders’ agreements,
the ability to direct the relevant activities, and
exposure to variable returns.
In the entities listed below, although the Group holds ownership interests of less than 50.01%, they are fully consolidated, mainly due to contractual arrangements and potential voting rights associated with call options that are (i) substantive, (ii) exercisable at the reporting date and (iii) financially feasible, which allows the conclusion that the Group has control (Note 17):
Entity
Ownership Interest
Haema GmbH (1)
BPC Plasma, Inc (1)
Plasmavita Healthcare GmbH (2)
Grifols (Thailand) Pte Ltd (3)
In general, significant influence is presumed when the Group holds an ownership interest of more than 20%. However, in determining whether significant influence exists, the Group considers not only the percentage of ownership and potential voting rights exercisable at the reporting date, but also qualitative factors such as representation on the Board of Directors, participation in key operating decisions such as approval of the business plan, dividend policy and budgets, as well as the involvement of management personnel with decision-making authority.
The investment listed below, in which the Group holds a 50.1% ownership interest, is accounted for using the equity method, as the contractual arrangements and governance structure limit the Group’s ability to control the entity but grant it the ability to influence its financial and operating policies (Note 10).
Grifols Canada Plasma, Inc. (formerly Canadian Plasma Resources Corporation)
50.1
The classification of certain financial instruments as either equity instruments or financial liabilities requires the application of complex judgments, particularly when, under certain circumstances, they could give rise to a cash outflow for the Group (Note 15 y 19(d)).
F-17
In certain contracts, the Group must assess whether there are contractual or implicit obligations that give rise to the recognition of liabilities or to the reclassification of certain instruments. These assessments require a detailed analysis of the contractual terms and their economic substance.
In relation to the contractual obligations arising from the agreement entered into with Haier for the sale of 20% of the shares in Shanghai RAAS, it has been concluded that:(i) as of the reporting date, the probability of an outflow of resources to Haier is very low, since—based on the analysis of different scenarios—it is expected that Grifols will meet the aggregate EBITDA amount corresponding to the 2024–2028 periods of the Grifols Diagnostic Solutions Group (Note 29(d)); and (ii) there is no contractual obligation for the Company to use its “commercially reasonable efforts” to cause its investee, Grifols Diagnostic Solutions, Inc., to declare and distribute dividends to its shareholders.
Lease contracts in which Grifols acts as lessee include extension options or early termination options. The estimation of the lease term involves significant judgment in determining the total number of years to be included in the measurement of the lease asset and lease liability. This term is determined by considering the business plan approved by Management. Any subsequent change in the lease term could have a significant impact on the amounts of lease assets and lease liabilities already recognised (Note 4(f)).
The Group periodically analyses the physical and transition risks associated with climate change, considering international scenarios and the recommendations of the Task Force on Climate-related Financial Disclosures (TCFD). Based on the information currently available, no material impacts have been identified that would require adjustments to the financial statements; however, these judgments could change in the future as a result of regulatory, technological or market developments (Note).
No changes have occurred in the judgments applied in prior periods in relation to existing uncertainties.
The Group is also exposed to risks related to changes in interest rates and foreign exchange rates. Reference is made to the sensitivity analyses included in Note 30.
b)Changes in the scope of consolidation
Appendix I shows details of the percentages of direct or indirect ownership of subsidiaries by the Company at 31 December 2025, 2024 and 2023, as well as the consolidation method used in each case for preparation of the accompanying consolidated financial statements.
F-18
In 2025
% total voting
Consolidation
% voting rights
rights following
Date
method
acquired
acquisition (1)
Araclon Biotech S.L. (2)
Grifols Innovation and New Technologies Limited
Acquisition
March and December
Full consolidation
1.27
77.12
Biotest AG (2)
Grifols S.A. y Grifols Biotest Holdings, GmbH
February, June, September, October
99.25
Biotest MidCo GmbH (formerly Blitz F25-957 GmbH) (2)
Grifols S.A.
March
100.00
Biotest Management GmbH (formerly Blitz F25-958 GmbH) (2)
Biotest MidCo GmbH
Grifols Canada Plasma II Inc.
November
Equity method
50.10
rights in entity
disposed of or
following
derecognized
disposal (1)
Biotest (UK) Ltd.
Grifols UK Ltd.
Merged
February
Medcom Advance, S.A.
Dissolved
45.00
Biotek America LLC (“ITK JV”)(2)
Grifols Bio North America LLC
Joint operation
75.00
Grifols Pyrenees Research Center, S.L.
Grifols Colombia, Ltda
Grifols, S.A.
December
F-19
In 2024:
July
20.00
Grifols Worldwide Operations Limited
October
Grifols Malaysia SDN BHD (2)
Grifols Asia Pacifit Pte Ltd
51.00
Biotest Italy, S.R.L.
Grifols Italia, S.p.A.
January
Biotest Medical, S.L.U.
Grifols Movaco, S.A.
Biotest Farmaceutica LTDA
Grifols Brasil Ltda.
Biotest France SAS
Grifols France S.A.R.L.
Mecwins, S.A.
Progenika Biopharma, S.A.
Reclassification due to loss of significant influence
24.59
F-20
In 2023:
31/12/2023
% total voting rights
Kiro Grifols, S.L.
10.00
AlbaJuna Therapeutics, S.L.
Grifols Innovation and New Technologies Ltd
June
Biomat Holdings, LLC
Incorporation
Grifols Plasma Canada - Ontario Inc
April
in entity following
Grifols Escrow Issuer, S.A.
Gripdan Invest, S.L.
Access Biologicals LLC
Grifols Bio Supplies, Inc.
Chiquito Acquisition Corp.
Geotech LLC
Grifols Shared Services North America Inc.
F-21
c) Amendments to IFRS in 2025
As of the date of preparation of these annual financial statements, the following standards published by the IASB and the IFRS Interpretations Committee and adopted by the European Union for application in Europe came into force and, therefore, have been taken into account in the preparation of these consolidated financial statements:
Effective in 2025
Mandatory application for annual periods
beginning on or after:
Standards
EU effective date
IASB effective date
IAS 1
Amendments to IAS 21 The Effects of Changes in Foreign Exchange Rates: Lack of Exchangeability
1 January 2025
The application of these standards and interpretations has had no significant impact on these consolidated financial statements.
Standards issued but not effective at 31 December 2025
At the date these consolidated financial statements were authorized for issue, the following IFRS and amendments have been published by the IASB but their application is not mandatory until the future periods indicated below:
IFRS 9 / IFRS 7
Amendments to the Classification and Measurement of Financial Instruments
1 January 2026
Contracts referencing Nature-dependent Electricity
Annual Improvements Volume 11
IFRS 18
Presentation and Disclosure in Financial Statements
1 January 2027
IFRS 19
Subsidiaries without Public Accountability: Disclosures
Pending
without Public Accountability:
IAS 21
Amendments to IAS 21 The Effects of Changes in Foreign Exchange Rates: Translation to a Hyperinflationary Presentation Currency
The Group has not applied any of these standards or interpretations in advance of their effective date.
Management is currently assessing the potential impacts that the adoption of these standards and amendments may have on the consolidated financial statements upon initial application. In particular, the adoption of IFRS 18 — which will replace IAS 1 and will be applicable for annual periods beginning on or after January 1, 2027, with retrospective application unless specific transitional provisions are established — is expected to introduce significant changes in presentation and disclosures, with a primary focus on the Consolidated Statement of Profit and Loss. Specifically, the standard:
F-22
Regarding the remaining standards and interpretations effective in 2026 and 2027, no significant impacts on the consolidated financial statements are expected.
d) Changes in accounting criteria and corrections of error
In the consolidated financial statements for fiscal year 2024, the Group applied certain error corrections related to the accounting classification of the joint operation Biotek America LLC and the initial treatment of the investment in Shanghai RAAS Blood Products Co. Ltd. These corrections affected the comparative figures for fiscal years 2022 and 2023 and were described in detail in the notes to the 2024 financial statements. The present consolidated financial statements for 2025 already fully incorporate these adjustments, and no additional errors or changes in accounting policies have been identified during the year.
Detailed information regarding the nature and impact of these adjustments is available in the consolidated annual statements for fiscal year 2024.
With respect to Biotek America LLC, it was concluded that the arrangement should have been treated as a joint operation from its inception, which required the proportional recognition of the corresponding assets, liabilities, and results. The correction resulted in the recognition, as of December 31, 2023, of the joint operation’s assets and liabilities amounting to Euro 151 million and Euro 191 million, respectively, and in the recognition of a negative adjustment to reserves of 40 million euros, net of translation differences, corresponding to accumulated losses for fiscal years 2021 and 2022. It also resulted in a reduction in the profit attributable to the parent company of Euro 23 million in 2022 and Euro 17 million in 2023.
As regards Shanghai RAAS, it was identified that, in the initial recognition of the investment in 2020, the amount corresponding to the indirect interest in Grifols Diagnostic Solutions, Inc. should have been excluded. In accordance with the applicable accounting policy, this amount should have been recorded against the investment in SRAAS rather than against reserves. The correction resulted in a reduction in the carrying amount of the investment and in consolidated reserves totaling Euro 457 million, with no impact on the income statement of the affected fiscal years.
(3)Business Combinations and Divestments
In accordance with the agreements in force between Grifols Bio North America LLC (“GBNA”) and Immunotek GH LLC (“Immunotek”) (the “Immunotek Collaboration Agreement”), effective January 2, 2025, GBNA acquired a group of 8 plasma collection centers in the U.S. (the “Group 3 Centers”) from Immunotek for a total net amount of approximately US Dollars 79 million (Euros 75 million at the exchange rate prevailing on the transaction date).
F-23
Likewise, and despite the fact that the Collaboration Agreement with Immunotek provided that the acquisition of the Group 4 Centers (defined below) would be carried out in January 2026, in response to the strategic decision to optimize operational efficiency, Immunotek and Grifols signed an amendment to the Collaboration Agreement with Immunotek then in force, pursuant to which, effective 3 February 2025, GBNA acquired from Immunotek the last 6 plasma collection centers in the U.S. (the “Group 4 Centers”), for a purchase price of approximately US Dollars 62 million (Euros 59 million at the exchange rate prevailing on the transaction date), with payment of the price deferred until January 2, 2026 (as provided for in the original Immunotek Collaboration Agreement). As a result of the above, Grifols has recognized a short-term liability in 2025 for the deferred amount of the acquisition of the Group 4 Centers.
The deferred payment obligation was formalized by a promissory note between Biomat Holdings LLC, as issuer, and initially held by Immunotek, as holder of the note, for an aggregate amount of US Dollars 70 million (Euro 60 million) (hereinafter, the “Note”). This amount included, in addition to the purchase price, the management fees related to the centers until May 2025 and an implicit financing component representing the deferral in the purchase price, amounting in aggregate US Dollars 8 million (Euro 7 million). Subsequently, Immunotek assigned the Note to a subsidiary of a financial institution. The Note matured on 2 January 2026, on which date it was fully settled. The Group 4 Centers were encumbered as collateral of the promissory note and (following the same guarantee provided by Grifols S.A. under the Collaboration Agreement with Immunotek) the promissory note was guaranteed by Grifols, S.A.
Therefore, and following the acquisition of the Group 3 Centers and the Group 4 Centers, Grifols has gained control of the 14 centers in 2025 (previously integrated within a joint operation) and now owns and fully manages as of 1 May 2025, through its subsidiary Biomat Holdings LLC, the 28 plasma collection centers in the U.S. developed by Immunotek under the Collaboration Agreement with Immunotek. The collaboration with Immunotek has ended, and GBNA is no longer part of the joint operation, Biotek America LLC.
Grifols has applied the requirements for a business combination carried out in stages. However, considering that (i) Grifols’ effective participation in the joint operation is null and void and (ii) all of the assets and liabilities related to the joint operation are already recognized in the consolidated financial statements, the difference between the consideration paid and the fair value of the assets and liabilities, which does not differ from their carrying amount, It has been recognized as goodwill at the date of acquisition.
The aggregate detail of the cost of the business combination and goodwill as of the acquisition date is shown below:
Millions of Euros
Millions of US Dollar
Consideration
268
Advance payment
(134)
(140)
Net consideration
Step-up of net assets adquired1
Adjustments from acquisition 2
Goodwill, net of adjustments
241
253
1There is no revaluation of net assets since the fair value of the same does not differ from their carrying value, which was previously recognized in the consolidated financial statements in the context of a joint operation.
2The adjustments resulting from the acquisition relate primarily to the elimination of the net balance payable that the silos maintained with ImmunoTek. Such balances are the accumulated losses from the silos, which are allocated to ImmunoTek in accordance with the terms of the contract.
The resulting goodwill is allocated to the Biopharma segment and includes the donor database, licenses and workforce.
F-24
Finally, on 3 February 2025, Immunotek released three of the five warranties that Grifols Shared Services North America, Inc. (a wholly-owned subsidiary managed by Grifols) had granted to Immunotek in June 2023 for certain leases related to certain Immunotek plasma collection centers outside of the collaboration under the Biotek America LLC joint operation. The remaining two guarantees, totaling approximately US Dollars 20 million, remain in force and are expected to remain in effect for as long as the leases remain in effect, with their balance being reduced as the lease term in question is reduced.
If the acquisition had taken place on January 1, 2025, the Group’s revenue and net profit would not have changed, since the Group was already integrating those centers as a joint operation (see Note 10).
As a result of the collaboration agreement signed with ImmunoTek GH, LLC, Grifols acquired 7 silos on April 1, 2024 and 7 silos on July 1, 2024, one silo for each plasma center for an amount of US Dollars 135 million and US Dollars 131 million, respectively (Euros 121 million and Euros 125 million, respectively, at the exchange rate on the transaction date). These transactions enabled Grifols to gain control of the 14 centers as of their acquisition date in 2024, which had previously been considered within a joint operation.
Therefore, Grifols has applied the requirements for a business combination carried out in stages. However, considering that (i) Grifols’ effective participation in the joint operation is null and void and (ii) all of the assets and liabilities related to the joint operation are already recognized in the consolidated financial statements, the difference between the consideration paid and the fair value of the assets and liabilities, which does not differ from their carrying amount, has been recognized as provisional goodwill at the date of acquisition.
During 2025, and within 12 months from the acquisition date, the Group completed the analysis of adjustments arising from the acquisition, which resulted in an adjustment to goodwill amounting to Euros 3 million (US Dollars 3 million).
Consideration paid
246
266
Step-up of net assets 1
Adjustments from the acquisition 2
236
256
1There is no step-up of net of assets since the fair value and the carrying amount do no differ significantly. Additionally, the net assets were previously recognized in the consolidated financial statements as part of the joint operation.
2The adjustments resulting from the acquisition correspond mainly to the elimination of the net balance payable that the silos maintained with Immunotek. The net amount represents the accumulated losses from the silos, which were allocated to Immunotek in accordance with the terms of the contract (see note 10)
The resulting goodwill has been allocated to the Biopharma segment and includes the donor database, licenses and workforce.
The operations of these centers were already consolidated since the beginning of the agreement with Immunotek (see Note 10), so there is no impact either on turnover, given that all sales transactions are eliminated in the consolidation process, or on results if both transactions had taken place on January 1, 2024.
F-25
On 7 July, 2023, Grifols, through its 100% owned subsidiary Grifols Canada Plasma I (formerly Grifols Canada Plasma, Inc.), acquired a plasma donation center from Canadian Plasma Resources Corporation which was a business in accordance with IFRS 3. The purchase price was Canadian Dollars 12 million (Euros 8 million).
As of the acquisition date, the goodwill recognized (Note 6), resulting from the cost of the business combination and the fair value of the net assets acquired, amounted to Euros 8 million (Canadian Dollars 11 million).
The resulting goodwill was allocated to the Biopharma segment and includes the donor database, licenses and workforce. The entire goodwill is considered tax deductible.
On 9 October, 2023, Grifols, through its 100% owned subsidiary Grifols Innovation and New Technologies Limited (GIANT), reached an agreement to acquire the remaining of the 51% of the shares of Albajuna Therapeutics, S.L. (hereinafter “Albajuna”) for a total amount of 1 euro.
In 2016, Grifols made a capital investment of Euros 4 million in exchange for 30% of the shares of Albajuna Therapeutics, S.L. Since 2018, as a result of a planned investment in accordance with the Shareholders’ Agreement of January 2016, Grifols held a 49% of the shares in the company’s capital. Albajuna Therapeutics, S.L. is a Spanish research company founded in 2016 whose main activity is the development and manufacture of therapeutic antibodies against HIV.
As of the acquisition date, the goodwill recognized (Note 6) amounted to Euros 2 million. This amount resulted from the difference between the consideration transferred and the value of the net assets acquired, whose total amount is Euros 2 million and was mainly composed of non‑current financial liabilities.
As future economic benefits cannot be estimated at the acquisition date, the total amount allocated to goodwill has been totally impaired immediately upon recognition (see note 6).
(4)Significant Accounting Policies
a)
Subsidiaries
Subsidiaries are considered to be those over which the Group exercises control. A subsidiary is controlled when, due to its involvement in it, it is exposed, or has the right, to variable returns and has the capacity to influence such returns through the power it exercises over it.
The income, expenses and cash flows of subsidiaries are included in the consolidated financial statements from the date of acquisition, which is the date on which the Group effectively obtains control of the subsidiaries. Subsidiaries are excluded from consolidation from the date on which control is lost.
Transactions and balances with Group companies and unrealized gains or losses have been eliminated in the consolidation process.
The accounting policies of the subsidiaries have been adapted to the Group’s accounting policies for transactions and other events that, being similar, have occurred in similar circumstances.
F-26
The financial statements of the subsidiaries used in the consolidation process are as of the same reporting date and the same period as those of the Parent Company.
Appendix I includes information on the subsidiaries included in the Group’s consolidation.
Business combinations
The acquisition method is used to account for the acquisition of businesses in a business combination. The acquisition date is the date on which the Group obtains control of the acquired business.
The acquisition cost of a business is determined at the acquisition date and comprises (i) the fair values of assets acquired, (ii) liabilities incurred or assumed, (iii) equity instruments issued, (iv) the fair value of any asset or liability resulting from a contingent consideration arrangement and (v) the fair value of any previous interest in the business.
Any disbursement that is not part of the exchange for the acquired business is excluded.
Acquisition-related costs are expensed as incurred.
The Group recognizes identifiable assets acquired and liabilities and contingent liabilities assumed at fair value at the acquisition date. Non-current assets held for sale, liabilities for employee compensation, transactions with payments based on equity instruments, deferred tax assets and liabilities and right-of-use assets and lease liabilities are excluded from the application of this criterion.
The positive difference between the acquisition cost of the business and the fair value of the identifiable net assets is recognized as goodwill. If the difference is negative, it is recognized as a gain in the consolidated statement of profit and loss, as a bargain purchase.
When settlement of any part of the cash consideration is deferred, amounts payable in the future are discounted to their present value at the date of exchange.
The contingent consideration is recognized at fair value on the acquisition date and is classified as equity or as a financial liability based on the criteria established in IAS 32 “Financial Instruments: Presentation”. Amounts classified as a financial liability are subsequently remeasured at fair value, with changes in fair value recognized in profit or loss.
When the business combination could only be determined on a provisional basis, the identifiable net assets are initially recorded at their provisional values, recognizing the adjustments made during the measurement period as if they had been known at the acquisition date, restating comparative figures for the previous year, if applicable. The adjustments to the provisional values only incorporate information relating to facts and circumstances that existed at the acquisition date and which, had they been known, would have affected the amounts recognized at that date. The measurement period should not exceed twelve months from the date of acquisition.
If the business combination is achieved in stages, the carrying amount of the previously held interest in the acquire’s equity is remeasured at its fair value on the acquisition date, with any resulting gain or loss recognized in profit or loss.
Non-controlling interests in subsidiaries are recorded at the acquisition date at their percentage of interest in the fair value of the identifiable net assets, without considering potential voting rights. In addition, the profit or loss for the year and each component of other comprehensive income allocated to the non-controlling interest is allocated in proportion to its percentage of ownership. Non-controlling interests in the results and equity of subsidiaries are shown separately in the consolidated statement of profit and loss, the consolidated statement of comprehensive income, the consolidated statement of changes in equity and the consolidated balance sheet, respectively.
F-27
The increase and reduction of non-controlling interests in a subsidiary while maintaining control is recognized as an equity transaction in reserves.
Associated
Associated entities are those over which the Group exercises significant influence, understood as the capacity to intervene in financial and operating decisions, without the existence of control or joint control.
Investments in associates are initially recognized at acquisition cost, including costs directly attributable to the acquisition and any active or passive contingent consideration that depends on future events or the fulfillment of certain conditions.
Subsequently, investments in associates are accounted for by the equity method from the date on which significant influence exists until the date on which the Company can no longer justify the existence of significant influence.
The excess between the cost of the investment and the Group’s share of the fair values of the identifiable net assets is recorded as goodwill, which is included in the carrying amount of the investment. The shortfall, once the amounts of the cost of the investment and the identification and valuation of the net assets of the associate have been evaluated, is recorded as income in the determination of the investor’s share in the results of the associate for the year in which it was acquired.
The accounting policies of the associated companies have been subject to time and valuation standardization in the same terms as those referred to in the subsidiaries.
The Group’s share in the profits or losses of associates obtained from the date that the significant influence exists is recorded as an increase or decrease in the value of the investments with a credit or debit to “Profit of equity accounted investees with similar activity to that of the Group” when the investee companies carry out the same activity as the corporate purpose of the Group described in note 1 and, otherwise, in “Profit /(loss) of equity accounted investees”. Likewise, the Group’s share in the other comprehensive income of associates obtained since date that the significant influence exists is recorded as an increase or decrease in the value of the investments in associates, with the balancing entry by nature being recognized in other comprehensive income. Dividend distributions are recorded as decreases in the value of investments.
When the Group’s share of losses on an equity accounted investment equals or exceeds its interest in the entity, the Group does not recognize additional losses unless it has incurred obligations or made payments on behalf of the other entity.
The Group’s share in the profits or losses of associates and changes in equity is determined on the basis of the ownership interest at year-end, without considering the possible exercise or conversion of potential voting rights. However, the Group’s share is determined considering the possible exercise of potential voting rights and other derivative financial instruments that, in substance, grant current access to the economic benefits associated with ownership interests, i.e. the right to participate in future dividends and changes in the value of associates.
After applying the equity method, the Group assesses whether there is objective evidence of impairment of the net investment in the associate. Some of the main evidence include significant cumulative losses, contractual default, financial difficulties and adverse changes in technology, industry or economy affecting the associate. The impairment calculation is determined by comparing the carrying amount of the net investment in the associate with its recoverable amount, where recoverable amount is the higher of value in use or fair value less costs of disposal. In this regard, the value in use is calculated based on the Group’s share of the present value of the estimated cash flows from ordinary activities and the amounts that could result from the final disposal of the associate. The recoverable amount of the investment in an associate is assessed in relation to each associate (see note 10), unless it does not constitute a cash-generating unit (CGU). Impairment losses are not allocated to goodwill or other assets implicit in the investment in associates arising from the application of the acquisition method. In subsequent years, reversals of the value of investments are recognized against income, to the extent that there is an increase in the recoverable value. Impairment losses are presented separately from the Group’s share in the results of associates.
Appendix I includes information on subsidiaries and associates included in the Group’s consolidation.
F-28
Joint agreements
Joint arrangements are those in which there is a contractual agreement to share control over an economic activity, so that decisions on the relevant activities require the unanimous consent of the Group and the other participants. Investments in joint arrangements are classified as joint operations or joint ventures, depending on the contractual rights and obligations of each investor, rather than the legal structure of the joint arrangement.
Joint transactions are considered when the participants in the joint arrangement are entitled to the assets and obligations in respect of the liabilities. This type of arrangement is consolidated proportionally integrating the assets and liabilities related to the transaction as described in note 10.
Joint ventures are those when the participants in the agreement have a right to the net assets. This type of arrangement is included in the consolidated financial statements using the equity method, as described in note 10.
b)Transactions and balances in foreign currencies
Transactions in foreign currencies are translated to the functional currency using the average exchange rate of the previous month provided that it does not differ significantly from the exchange rate at the date of the transaction. Foreign currency gains and losses resulting from the settlement of these transactions and from the translation of monetary assets and liabilities denominated in foreign currencies at closing exchange rates are recognized in profit or loss except when there are qualified cash flow hedges and qualified net investment hedges that are deferred to equity.
The effect of exchange rate changes on cash and cash equivalents denominated in foreign currencies is presented separately in the statement of cash flows as “Effect of exchange rate changes on cash”.
The translation of foreign operations whose functional currency is not that of a hyperinflationary country has been made by applying the following criteria:
F-29
Disposal of a subsidiary or associate that includes a foreign operation
Treatment of translation differences
Disposal of an interest in a subsidiary without loss of control
Translation differences are attributed to the non-controlling interests in proportion to their ownership interest. No impact is recognized in profit or loss.
Disposal of an interest in a subsidiary resulting in loss of control and retention of significant influence
The full amount of translation differences is reclassified to profit or loss.
Disposal of an interest in an associate without loss of significant influence
Translation differences are reclassified to profit or loss in proportion to the interest disposed of.
Disposal of an interest in a subsidiary or associate where the retained interest is accounted for as a financial investment
Impairment of a foreign investment
No impact
Conversion of a “net investment in a foreign operation” loan in a equity instrument
Full or partial repayment of quasi-equity loan
Provided that the repayment does not result in a change in the Group’s ownership interest in the foreign operation or a loss of control, such repayment is not considered a disposal and, accordingly, no reclassification to profit or loss is recognized.
c)Goodwill
After initial recognition, goodwill is recorded at cost, less any accumulated impairment loss, which is not reversible. Goodwill is not amortized, but is tested for impairment on an annual basis or more frequently in the event that events indicative of a potential loss in the value of the asset have been identified. For these purposes, goodwill resulting from business combinations is allocated to each of the cash generating units (CGUs) or groups of CGUs that are expected to benefit from the synergies of the combination and the criteria referred to in note 6 are applied. CGUs or groups of CGUs are identified at the lowest level that goodwill is controlled for the purpose of internal management (note 6).
d)Intangible assets
Intangible assets are recorded at cost (acquisition or development) or at fair value when acquired in a business combination, less accumulated amortization and any accumulated impairment losses.
Any costs incurred during the research phase of projects are recognized as an expense when incurred.
Costs related to development activities for internally generated intangible assets are capitalized to the extent that:
F-30
In relation to the development costs of new products or drugs, they are capitalized as long as their economic profitability is reasonably assured and when they are either in a pivotal phase or correspond to projects related to products that are currently being marketed in various markets, in both cases with expected technical feasibility. Development costs previously recognized as an expense are not recognized as an asset in a subsequent period.
The separate acquisition or through a business combination of an research and development project in progress is capitalized in any case, in accordance with the provisions of IAS 38, since the price paid for the acquisition reflects expectations about the probability that the future economic benefits of the asset are used by the Group. Subsequent costs are recorded following the provisions for internally generated intangible assets.
The Group amortizes its intangible assets with finite useful lives by distributing the cost of the assets on a straightline basis according to the following criteria:
Amortisation method
Rates
Development expenses
Straight-line
5% - 14%
Concessions, patents, licenses, trademarks and similar
4% - 20%
Computer software
33%
Currently marketed products
3% - 10%
Intangible assets with indefinite useful lives are not subject to amortization but are tested for impairment at least once a year.
The Group reviews the useful lives of intangible assets at the end of each year. Changes in the initially established criteria are recognized as a change in estimate.
e)Property, plant and equipment
Property, plant and equipment are stated at cost, less accumulated depreciation and, if applicable, accumulated impairment losses.
Cost includes, among other items, direct labor costs used in the construction of the asset and a portion of the costs indirectly attributable to the asset.
Finance costs incurred that are directly attributable to the acquisition or construction of the asset until the asset is ready for use also form part of the cost.
Likewise, expansion or improvement costs are included as an increase in the value of the asset when they represent an increase in its capacity or an extension of its useful life. However, maintenance costs are recognized in income when incurred.
The depreciation of property, plant and equipment begins when the asset is available for use and is calculated by allocating its cost, less its residual value, on a straight‑line basis over its estimated useful life.
F-31
Depreciation of property, plant and equipment is determined by applying the following criteria:
Depreciation method
Buildings
1% - 3%
Other property, technical equipment and machinery
4% - 10%
Other property, plant and equipment
7% - 33%
The Group reviews the residual value, useful life and depreciation method of property, plant and equipment at the end of each reporting period. Changes in the initially established criteria are recognized as a change in estimate.
f)Leases
Lessee
The determination of whether a contract is or contains a lease is based on an analysis of the contractual arrangement and requires an assessment of whether the lessee has the right to control the use of the identified asset and to obtain all of the economic benefits from the use of the asset throughout the lease term.
The lease term is the non-cancelable period considering the initial term of each contract unless the Group has a unilateral extension or termination option and there is reasonable certainty that such option will be exercised in which case the corresponding extension or early termination term will be considered.
In lease contracts where the Group acts as lessee, it is recognized at the lease commencement date (i.e. the date on which the underlying asset is available for use):
Lease liabilities include fixed lease payments less any incentives, as well as variable payments that depend on an index or interest rate known at the date of inception of the lease. Also included is the exercise price of the purchase option when the lessee is reasonably certain of exercising it. After initial recognition, the liability is increased by the interest on the lease liability and reduced by the payments made. The liability is also remeasured if there are changes in the amounts payable and the lease terms. Payments included in the lease payments corresponding to maintenance, electricity, water, gas, security, cleaning, among others, are not part of the lease liability and are recognized as an expense.
The incremental borrowing rate is determined taking into account: (i) geographic areas, (ii) financial term, (iii) lease term, (iv) risk-free rate as reference rate and (v) financial spread.
Rights-of-use assets are measured at cost, less accumulated amortization and impairment losses (if any) and adjusted as a result of the remeasurement of the lease liability. Cost includes the amount of the initial valuation of the lease liability, as well as any amounts previously paid to the lessor prior to or at the commencement date of the lease less any incentives received by the lessor and estimated costs to decommission the leased asset. Amortization of rights of use is provided on a straight-line basis over the shorter of the estimated useful life of the asset or the lease term.
The Group applies the exception to recognition for those contracts where the lease term is 12 months or less or where the value of the leased asset (individually) when new, is less than US Dollar 5,000 or its equivalent in another currency. Consequently, in these cases, the amounts accrued will be recognized as an expense during the lease term.
F-32
Lessor
When the Group acts as lessor, it classifies contracts between operating and finance leases. Leases in which the Group acts as lessor while retaining a significant portion of the risks and rewards incidental to ownership of the leased asset are treated as operating leases. Otherwise, the lease is treated as a finance lease.
g)Impairment of non-financial assets
Goodwill and intangible assets that have an indefinite useful life are not subject to amortization and are tested for impairment annually, or more frequently in the event of events or changes in circumstances that indicate that they may be impaired.
Other assets are tested for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable.
When the recoverable amount is less than the carrying amount of the asset, an impairment loss is recognized in the consolidated statement of profit and loss for the difference between both amounts.
The recoverable amount is the higher of an asset’s fair value less costs of disposal and the estimated value in use based on discounted future cash flows expected to arise from the use of the asset. The estimate of value in use considers expectations about possible variations in the amount or timing of cash flows, the time value of money, the price to be paid for bearing the uncertainty related to the asset and other factors that affect the valuation of future cash flows related to the asset.
For the purpose of assessing impairment losses, assets are grouped at the lowest levels for which there are separately identifiable cash inflows that are largely independent of the cash inflows of other assets or groups of assets (cash generating units). Impairment losses on non-financial assets (other than goodwill) are reviewed for possible reversal at the end of each reporting period.
Losses related to the impairment of CGUs are initially allocated to reduce, if applicable, the value of goodwill attributed to the CGU and then to the other assets of the CGU, pro rata based on the carrying amount of each asset, with the limit for each asset being the higher of its fair value less costs of disposal, its value in use and zero.
Impairment losses related to goodwill are not reversible.
h)Financial instruments
Financial assets
Classification
The classification of financial assets is determined based on the characteristics of the contractual cash flows of those assets and the business model that represents how the financial assets are managed to achieve a particular business objective. In determining whether the cash flows are obtained through the receipt of contractual cash flows from the assets, consideration is given to the frequency, value and timing of sales in prior periods, the reasons for those sales and expectations regarding future sales activity. This information provides indicative data on how the Group’s stated objective regarding the management of financial assets is achieved and, more specifically, how cash flows are obtained.
F-33
Therefore, financial assets are classified according to the following valuation categories based on the business model and are only reclassified when, and only when their business model for managing them changes:
Initial measurement
Financial assets are recorded, in general terms, initially at the fair value of the consideration given plus directly attributable transaction costs. However, transaction costs directly attributable to assets recorded at fair value through profit or loss are recognized in the statement of profit and loss for the year.
Subsequent measurement
Financial assets at amortized cost are recorded by applying this valuation criterion, charging to the statement of profit and loss the interest accrued by applying the effective interest rate method.
Financial assets included in the fair value category through other comprehensive income are recorded at fair value, without deducting any transaction costs that may be incurred in their disposal. Changes in fair value are recorded directly in equity until the financial asset is derecognized or impaired, at which time the amount so recognized is taken to the statement of profit and loss.
Financial assets at fair value through profit or loss are measured at fair value and the result of changes in fair value is recorded in the statement of profit and loss.
Disposals of financial assets
Financial assets are derecognized when the rights to receive cash flows related to them have expired or have been transferred and the Group has substantially transferred the risks and rewards of ownership. Similarly, they are disposed from the balance sheet when there are transfers of collection rights, whose certain risks are shared with the factor, such as the risk of default, but exists a transfer of control to the factor, understood as the unilateral capacity to sell those assets to a non-related third party without the necessity of enforcing additional restrictions to the sale.
F-34
Impairment
The Group assesses, on a prospective basis, the expected credit losses associated with its debt instruments carried at amortized cost and at fair value through other comprehensive income The methodology applied for impairment depends on whether there has been a significant increase in credit risk.
For trade receivables, the Group applies the simplified approach permitted by IFRS 9 which requires expected losses to be recorded from the initial recognition of the receivables, so that the Group determines expected credit losses as a probability-weighted estimate of such losses over the expected life of the financial instrument.
The practical solution used is the use of a provisioning matrix based on segmentation into homogeneous asset groups, applying historical information on default rates for these groups and applying reasonable information on future economic conditions.
Default rates are calculated based on current default experience over the past year, as it is a very dynamic market, and are adjusted for differences between current and historical economic conditions and considering projected information, which is reasonably available.
Financial liabilities
Financial liabilities assumed or incurred by the Group are classified in the following measurement categories:
Derivative financial liability instruments are measured at fair value, following the same criteria as those corresponding to financial assets at fair value through profit or loss described in the preceding section.
The Group disposes financial liabilities when the obligations that generated them are extinguished, particularly in commercial transactions when payment is made to the supplier for goods and services.
Assets and liabilities are presented separately in the balance sheet and are only presented at their net amount when the Group has the enforceable right to offset the recognized amounts and, in addition, intends to settle the amounts on a net basis or to realize the asset and settle the liability simultaneously.
Equity instruments
The Group holds financial assets, mainly equity instruments, which are measured at fair value. When Group management has opted to present gains and losses in the fair value of equity investments in other comprehensive income, after initial recognition, the equity instruments are measured at fair value, recognizing the gain or loss in other comprehensive income. Amounts recognized in other comprehensive income are not reclassified to profit or loss, but are reclassified to reserves when the instruments are disposed. Dividends from such investments continue to be recognized in profit or loss as other income when the Group’s right to receive payments is established.
F-35
i)Derivative financial instruments and hedging activities
Financial derivatives are recognized at fair value at the date of the contract and at each year-end. The method for recognizing the gain or loss depends on whether the derivative is classified as a hedging instrument, and if so, the nature of the hedged asset.
For accounting purposes, they are classified as follows:
(i) Derivatives qualifying for cash flow hedge accounting
Hedging effectiveness
Hedge effectiveness is determined at the inception of the hedging relationship, and through periodic prospective effectiveness assessments to ensure that there is an economic relationship between the hedged item and the hedging instrument.
In derivatives such as the euro/dollar cross-currency swap, the Group uses the hypothetical derivative method to assess effectiveness. This hypothetical derivative is constructed without the inclusion of credit risk and currency spread. Under the hypothetical derivative method, the cumulative change in the fair value of the actual currency swap, excluding the effect of the currency spread, will be compared to the cumulative change in the fair value of the hypothetical swap. Therefore, the hypothetical derivative is constructed as a cross-currency swap with fixed euro payment, fixed U.S. Dollar receipt without the inclusion of credit risk and foreign currency spread and with a fair value of zero at the date of designation.
Recognition
At the inception of the hedging relationship, the Group documents the economic relationship between the hedging instruments and the hedged items, including whether changes in cash flows of the hedging instruments are expected to offset changes in cash flows of the hedged items. The Group documents its risk management objective and strategy for undertaking its hedging transactions.
The effective portion of changes in the fair value of derivatives designated and classified as cash flow hedges is recognized in equity under “Cash flow hedge reserve”. In the case of cross-currency swaps, the currency spread of the hedging relationship is excluded and treated as hedging costs in equity. The gain or loss corresponding to the ineffective portion is recognized immediately in profit or loss for the year under the heading “Change in fair value of financial instruments”.
Amounts accumulated in the hedging reserve included in shareholders’ equity are transferred to profit or loss when the hedged item affects profit or loss or when ineffectiveness is identified.
The fair value of derivatives designated as hedges is detailed in note 30. Movements in the hedging reserve included in shareholders’ equity are shown in note 15(c).
(ii) Derivatives that do not qualify for hedge accounting
When derivatives do not meet the criteria for hedge accounting, they are classified as “held for trading”. Changes in fair value are recognized immediately in the consolidated statement of profit and loss.
In addition, Grifols assesses whether embedded derivatives are present in contracts and financial instruments. Financial instruments that combine a host contract and a financial derivative (embedded derivative) are known as hybrid financial instruments. In hybrid financial instruments, the Group assesses whether the risks and characteristics of the derivative are closely related to those of the host contract. If it is determined that the value of the derivative is closely related to the fair value of the contract, the Group does not account for the derivative separately. Conversely, if the risks and characteristics of the derivative are not closely related to those of the host contract and the host contract is not measured at fair value, the derivative is recognized and accounted for separately recognizing the changes in fair value in the Consolidated Statements of Profit and Loss. Currently there are no separate financial instruments from the host contract.
F-36
j)Own equity instruments
The acquisition of treasury stock is recorded at acquisition cost, reducing equity until the time of disposal. Gains or losses on the disposal of treasury stock are recorded under “Reserves” in the consolidated balance sheet. Transaction costs related to own equity instruments, net of taxes, are recorded as a reduction in equity.
k)Inventories
Inventories are stated at the lower of weighted average cost or net realizable value. Net realizable value is the estimated selling price in the normal course of business, less the estimated costs to complete production and those necessary to make the sale. For raw materials and other supplies it is the replacement cost.
The cost includes direct materials, direct labor and an appropriate proportion of indirect variable and fixed costs, the latter being allocated on the basis of the normal working capacity of the means of production. The cost of plasma inventory includes the amount delivered to donors, or the amount invoiced by the seller when purchased from third parties, as well as the cost of products and devices used in the collection process, and rental and storage costs. The costs of purchased inventories are determined after deducting discounts and rebates when it is probable that the conditions determining their concession will be met. Indirect costs such as management and administrative overheads are recognized as expenses in the period in which they are incurred.
Any previously recognized inventory impairment adjustment is reversed against income under “Cost of sales” when the circumstances that caused the impairment no longer exist or when there is clear evidence of an increase in the net realizable value as a result of a change in economic circumstances. The reversal of the inventory impairment adjustment is limited to the lower of cost and the new net realizable value of inventories.
l)Cash and cash equivalents
Cash and cash equivalents include cash on hand, demand deposits with banks, other short-term highly liquid investments with an original maturity of three months or less that are readily convertible to known amounts of cash and which are subject to an insignificant risk of changes in value. Additionally, balances of cash and cash equivalents that are not available for use by the Group are presented as restricted cash.
m)Government grants
Government grants are recognized when there is reasonable assurance that the conditions attached to the grant will be met and that the grant will be collected.
Non-refundable capital grants are recorded on the liability side of the consolidated balance sheet at the original amount granted and are recognized in the consolidated statement of profit and loss as the related assets financed are depreciated.
Grants received as compensation for expenses or losses already incurred or for the purpose of providing immediate financial support not related to future expenses are credited to the consolidated statement of profit and loss.
Financial liabilities that incorporate implicit aid in the form of the application of below-market interest rates are recognized initially at fair value. The difference between this value, adjusted where appropriate for the costs of issuing the financial liability and the amount received, is recorded as a government grant based on the nature of the grant.
n)Employee benefits
(i) Defined contribution plans
The Group records the contributions to be made to defined contribution plans as they accrue. The amount of accrued contributions is recorded under “Personnel expenses” in the consolidated statement of profit and loss in the year to which the contribution relates.
F-37
(ii) Defined benefit plans
The liability recognized corresponds to the present value of the obligation at the consolidated balance sheet date less the fair value of plan assets. The defined benefit obligation is calculated annually by independent actuaries using the projected unit credit method. The present value of the obligation is determined by discounting the estimated future cash flows at interest rates of bonds denominated in the currency in which the benefits will be paid and with maturities similar to those of the related obligations. Actuarial gains and losses arising from changes in actuarial assumptions or differences between assumptions and reality are recognized in equity under “Other comprehensive income”. Past service costs are recognized in the consolidated statement of profit and loss under “Personnel expenses”.
(iii) Termination benefits
Termination benefits are recognized on the earlier of the following dates: (a) when the Group can no longer withdraw the offer or (b) when the Group recognizes costs of a restructuring within the scope of IAS 37 and this results in the payment of termination benefits.
(iv) Short-term employee benefits
The Group recognizes the expected cost of short-term compensation in the form of paid leave whose rights accrue as employees render the services that entitle them to receive it.
The Group recognizes the expected cost of profit sharing or employee incentive plans when there is a present legal or constructive obligation as a result of past events and a reliable estimate can be made of the value of the obligation.
(v) Share-based payments
The Group has granted different incentive plans based on equity instruments to certain members of the management team who are rendering service to the company, which will be settled with equity instruments or cash, depending on the plan.
The equity instruments granted become vested when the employees complete a certain period of service and/or meet the objectives established in the incentive plan. Grifols recognizes the services received from its employees as such services are rendered during the vesting period as a personnel expense in the Consolidated Statements of Profit and Loss and a corresponding increase in equity if the transaction is equity-settled or a corresponding liability if the transaction is cash-settled, at an amount based on the value of the equity instruments.
In transactions with employees that are equity-settled, the amount recognized corresponds to the amount that will be settled once the agreed conditions are met and will not be reviewed or revalued during the vesting period, as the commitment is equity-settled. The fair value of services received is estimated by estimating the fair value of the shares granted at the grant date, net of estimated dividends to which the employee is not entitled, during the performance period.
For plans that are settled in cash, the services received and the corresponding liability are recognized at the fair value of the liability, referring to the date on which the requirements for recognition are met. Subsequently, and until settlement, the corresponding liability is measured at its fair value at the closing date of each year, with any changes in valuation occurring during the year being recognized in the Consolidated Statements of Profit and Loss. The fair value is determined by reference to the market value of the shares at the date of the estimate, net of estimated dividends to which the employee is not entitled, during the performance period.
o)Provisions
Provisions are recognized when the Group has a present legal or constructive obligation as a result of a past event, it is probable that an outflow of resources embodying economic benefits will be required to settle the obligation and a reliable estimate can be made of the amount of the obligation. Provisions are not recognized for future operating losses.
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The amount of the provision corresponds to the best estimate at the closing date of the disbursements required to settle the present obligation, after taking into account the risks and uncertainties related to the provision and, when significant, the financial effect of discounting, provided that the disbursements to be made in each period can be reliably determined.
p)Revenue recognition
The Group recognizes revenue in an amount that reflects the consideration it expects to be entitled to for transferring goods or providing services to its customers, when control of those goods or services is transferred to the customer. Contractual consideration may include fixed and variable amounts (e.g., discounts, returns, chargebacks, volume incentives, penalties, or performance bonuses). Variable consideration is included in the transaction price only when it is highly probable that a significant reversal of revenue recognized will not occur in the future. Revenue is presented net of VAT/indirect taxes and any amount collected on behalf of third parties.
Identification and Allocation of Performance Obligations:
Contracts with multiple components (e.g., rent of equipment together with maintenance and reagents) are not significant to the Group. In respect of such arrangements, Grifols identifies each distinct performance obligation and allocates the transaction price based on observable or estimated standalone selling prices, recognizing revenue when (or as) each obligation is satisfied.
Significant Financing Component:
The Group assesses whether the payment terms give rise to a significant financing component. When the period between the transfer of goods/services and payment is less than 12 months, the practical expedient under IFRS 15 is applied and the price is not adjusted for financing effects.
Warranties and Returns:
Standard defect warranties (which do not constitute separate performance obligations) are accounted for under IAS 37 through warranty provisions. Expected returns and return rights are recognized as sales reductions and return assets where applicable. The amounts related to these items are not material to the Group.
(i) Sales of goods
Revenue from the sale of goods (e.g., plasma-derived products, diagnostic products, equipment/instrumentation, hospital products) is recognized when Grifols satisfies the performance obligation by transferring control of the promised good to the customer. To assess the transfer of control, the following indicators, among others, are considered:
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Variable Consideration (United States and Other Markets)
(ii) Provision of services
Revenue from services (e.g., diagnostic services, maintenance and technical support, toll manufacturing/maquila) is recognized over time when one of the following criteria is met:
If a performance obligation does not meet these criteria, revenue is recognized at a point in time, when control is transferred (e.g., delivery and customer acceptance of the asset, right to payment, and transfer of risks/benefits).
Diagnostic services:
These include instrument service contracts with committed reagent consumables (reagent rental), maintenance, and technical support.
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Toll manufacturing (maquila / plasma processing):
The plasma is provided by the customer, and Grifols processes that plasma into finished products for the customer:
(iii) Transaction price and payment terms
The transaction price includes fixed amounts and the best estimate of variable amounts not subject to significant reversal. Payment terms vary by country, customer, and business line; typical terms do not give rise to a significant financing component. Taxes and levies collected on behalf of third parties are excluded from revenue.
(iv) Contract assets and liabilities
q)Income tax
The income tax expense or tax credit for the year comprises both current tax and deferred tax.
Current tax is the amount payable on the taxable income for the current year based on the applicable tax rate for each jurisdiction. It is calculated on the basis of the laws enacted or about to be enacted at the balance sheet date in the countries where subsidiaries and associates operate and generate taxable income. The Group periodically evaluates the positions taken in tax returns with respect to situations where the applicable tax regulations are subject to interpretation and considers such uncertainty in uncertain tax treatments when determining the corresponding tax gain or loss, tax bases, unused tax credits or tax rates.
Deferred taxes are recognized on temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the consolidated financial statements. It is determined using tax rates (and laws) enacted or about to be enacted at the balance sheet date that are expected to apply when the related deferred tax asset is realized or the deferred tax liability is settled.
Deferred tax liabilities and assets are recognized:
The Group recognizes deferred tax liabilities in all cases except those which:
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The Group recognizes deferred tax assets whenever:
Deferred tax assets and liabilities are not recognized for temporary differences between the carrying amount and tax base of investments in foreign operations when the company is able to control the date on which the temporary differences will reverse and it is probable that the temporary differences will not reverse in the foreseeable future. Likewise, deferred tax liabilities are not recognized if they arise from the initial recognition of goodwill. Lastly, deferred tax assets are only recognized if it is probable that sufficient future taxable profit will be available against which they can be utilized. The tax effects associated with the distribution of dividends by subsidiaries are recognized only when such dividends are declared or when its distribution is planned, given that the Group’s policy is to reinvest the reserves generated by its subsidiaries in the entities themselves and, additionally, the Group has control over the timing and amount of dividend distributions. Consequently, no deferred tax liability is recognized on the undistributed profits of subsidiaries, as the Group is able to control the distribution of such profits.
Deferred tax assets and liabilities are offset when there is a legally enforceable right to offset current tax assets and liabilities and when the deferred tax balances relate to the same taxation authority. Current tax assets and liabilities are offset when the entity has a legally enforceable right to offset and intends either to settle on a net basis or to realize the asset and settle the liability simultaneously.
Current or deferred income tax is recognized in profit or loss, unless it arises from a transaction or economic event that has been recognized in other comprehensive income or directly in equity. In such cases, the tax is also recognized in other comprehensive income or directly in equity, respectively.
r)Segment reporting
An operating segment is a component of the Group that engages in business activities from which it may earn revenues and incur expenses, whose operating results are regularly reviewed by the Group’s chief operating decision maker in order to decide on the resources to be allocated to the segment, evaluate its performance and for which discrete financial information is available.
s)Environment
The Group carries out operations whose main purpose is to prevent, reduce or repair damage to the environment as a result of its activities.
Items of property, plant and equipment acquired for the purpose of being used on a lasting basis in its activity and whose main purpose is the minimization of environmental impact and the protection and improvement of the environment, including the reduction or elimination of future pollution from the Group’s operations, are recognized as assets through the application of measurement, presentation and disclosure criteria consistent with those mentioned in note 4(e).
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t)Transactions between Group companies
Transactions between Group companies, except those related to mergers, spin-offs and non-cash business contributions, are recognised at the fair value of the consideration given or received. The difference between this value and the amount agreed is recognised in line with the underlying economic substance of the transaction.
In non-monetary contributions to Group companies, the contributor will value its interests at the carrying amount of the equity investments, in the consolidated financial statements at the date the transaction occurred.
Any difference between the value assigned to the interest received by the contributor and the carrying amount of the investments contributed will be recognised in reserves.
(5)Segment Reporting
In accordance with IFRS 8 “Operating Segments”, financial information for operating segments is reported as follows for at 31 December 2025, 2024 and 2023:
Consolidated
Not Assignable
Result
Revenue from external customers (1)
Material non-cash expenses (2)
(99)
(87)
Results of equity-accounted entities with activities similar to the Group (2)
Other operating revenue and expenses (2)
(4,634)
(484)
(104)
(243)
(5,736)
EBITDA (1)
1,746
(235)
1,693
Amortization (2)
Note 24(a)
(345)
(450)
Operating result (1)
1,401
(252)
(697)
Financial result (1)
Share of profit / (loss) of associates accounted for using the equity method
Income tax expense (1)
Consolidated net profit (1)
(995)
Segment assets
13,411
3,389
283
855
303
18,241
Equity-accounted investments
Unallocated assets
1,374
13,508
1,677
Segment liabilities
2,175
576
3,544
Unallocated liabilities
8,564
8,800
Key metrics reviewed by the CODM
Other material items
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(4,529)
(476)
(193)
(251)
(5,609)
1,599
(255)
1,630
(328)
(65)
(438)
1,271
(274)
(814)
(1,253)
14,233
3,755
349
890
19,227
2,109
14,302
2,324
523
514
3,443
9,356
(1)Key metrics reviewed by the CODM
(2)Other material items
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Intersegments
(4,370)
(500)
(107)
(241)
(253)
(5,464)
1,220
1,229
Note 24 (a)
(334)
(447)
(639)
(893)
13,420
3,529
380
1,841
19,170
364
421
13,477
2,205
20,992
2,460
467
3,105
10,374
13,479
The definition of business segments is based on the different activities carried out by the Group and their economic relevance, as well as on the organizational structure used for the management of the businesses and the manner in which Management analyzes the main operating and financial metrics for the purposes of resource allocation and performance assessment of the Group.
Segment assets, liabilities, income and expenses include items directly attributable to each segment, as well as those that can be reasonably allocated. The main unallocated items correspond, in balance sheet, to equity, cash and cash equivalents and bank borrowings, and in the statement of profit or loss, to financial result and income tax expense.
The “Not assignable expenses” caption mainly comprises the following items:
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As of December 31, 2025 and 2024, inter‑segment transactions are not significant; consequently, the Group has eliminated sales with related parties within each segment. As of December 31, 2023, inter‑segment transactions amounted to 7 million euros.
In accordance with the Group’s corporate governance structure and its internal management and reporting model, the Chief Executive Officer (CEO) acts as the Chief Operating Decision Maker (CODM). The CEO receives operating and financial information on a monthly basis, structured by business segments, including forecasts, results for the period and key performance indicators, such as revenue and EBITDA or operating profit by segment. Such segment information constitutes the primary basis used by the CODM to assess the performance of the different segments and to make decisions regarding resource allocation and the definition of strategic priorities.
Operating segments
The operating segments are as follows:
Details of sales by groups of products for 2025, 2024 and 2023 are as follows:
Haemoderivatives
Transfusional medicine
623
625
648
Other diagnostic
Bio supplies
The Group has concluded that hemoderivative products are sufficiently alike to be considered as a whole for the following reasons:
At 31 December 2025, 95.3% of the income from the sale of goods and services has been recognized at a certain point-in-time (94.9% in 2024 and 98.0% in 2023).
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b)Geographical information
Geographical information is grouped into four areas:
The definition of these four segments is mainly due to the geographical level that Group management sets to manage its revenue as they respond to specific economic scenarios. The main framework of the Group is consistent with this geographical segment grouping, including the monitoring of its commercial operations and its information systems.
The financial information reported as follows for geographical areas is based on sales to third parties in these markets as well as the asset location.
Rest of European
Union
USA and Canada
Rest of the world
Revenues
Other information:
418
1,196
Assets by geographical area
1,639
6,943
10,673
457
Additions for the year of property, plant & equipment, intangible assets and rights of use
319
1,076
1,635
7,584
11,790
396
479
363
893
1,191
7,055
10,967
1,779
214
c)Main customers
In 2025 and 2024 there is no customer that represents more than 10% of the Group’s gross revenue. In 2023, a customer in the Biopharma segment represents approximately the 10.37% of the Group’s gross revenue.
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(6)Goodwill
Details of and movement in this caption of the consolidated balance sheet at 31 December 2025 are as follows:
Balance at
Business
Segment
Combination
Net value
Grifols UK, Ltd. (UK)
Grifols Italia.S.p.A. (Italy)
Biomat USA, Inc. (USA)
912
(106)
806
Grifols Australia Pty Ltd. (Australia) / Medion Diagnostics AG (Switzerland)
Grifols Therapeutics, Inc. (USA)
2,139
(248)
1,891
Progenika Biopharma, S.A. (Spain)
Grifols Diagnostic (Novartis & Hologic) (USA, Spain and Hong Kong)
2,795
(321)
2,474
Kiro Grifols, S.L. (Spain)
Haema, GmbH. (Germany)
BPC Plasma, Inc. (USA)
Plasmavita Healthcare GmbH (Germany)
Alkahest, Inc (USA)
Grifols Canada Therapeutics, Inc (Canada)
GigaGen, Inc (USA)
Haema Plasma Kft. (Hungary)
Grifols Canada Plasma II. (formerly Grifols Canada Plasma Inc.) (Canada)
Grifols Biotest Holdings GmbH / Biotest AG (Germany)
304
Grifols Bio Supplies Inc (USA)
Biomat Holdings LLC (USA)
(54)
433
(804)
(See Note 3)
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Details of and movement in this caption of the consolidated balance sheet at 31 December 2024 were as follows:
Disposals
869
2,011
2,629
Biomat Holdings LLC (EEUU)
233
6,802
388
(see Note 3)
Impairment testing:
i) CGUs structure
CGUs correspond to the reporting segments except for the Others segment which corresponds to Kiro Grifols, Alkahest and GigaGen as separated CGUs.
As a result of the acquisition of Talecris in 2011, and for impairment testing purposes, the Group combines the CGUs allocated to the Biopharma segment, grouping them together at segment level, because substantial synergies were expected to arise on the acquisition of Talecris, and due to the vertical integration of the business and the lack of an independent organized market for the products. Because the synergies benefit the Biopharma segment globally they cannot be allocated to individual CGUs. The Biopharma segment represents the lowest level to which goodwill is allocated and is subject to control by Group management for internal control purposes.
As a result of the acquisition of Novartis’ Diagnostic business unit in 2014, the Group decided to combine Araclon, Progenika, Australia and Hologic’s share of NAT donor screening unit acquisition into a single CGU for the Diagnostic business as the acquisition is supporting not only the vertically integration business but also cross-selling opportunities. In addition, for management purposes, the Group’s management is focused on the business more than geographical areas or individual companies.
In addition, due to the acquisition of the remaining 51% stake in Access Biologicals LLC in the year 2022, a new CGU for the Bio Supplies business was identified.
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The CGUs established by Grifols management are:
Alkahest’s goodwill was generated as a counterpart to the deferred tax liability corresponding to the intangible assets recognized as a result of the allocation of the excess purchase price over the acquired net assets.
ii) Impairment
The recoverable amount of the Biopharma CGU, Bio Supplies and Kiro Grifols CGU has been determined based on its value in use, calculated as the present value of the five-year future cash flows, approved by management, discounted at a discount rate considering the related inherent risk.
The recoverable amount of the Diagnostic CGU has been calculated based on its fair value less costs to sell calculated as the present value of future cash flows approved by Management discounted at a discount rate considering the inherent risk (Level 3 in the fair value hierarchy). Due to the reorganization to boost the business units, a long- term strategic plan was approved in order to transform the Diagnostic business unit by investments which will lead to a beyond five-year growth. This transformation includes the expansion of the division into the adjacent Clinical Diagnostics market, as well as the launch of certain initiatives primarily focused on technological development to ensure leadership in the transfusion medicine market segment. However, the materialization of these assumptions depends on future events which, by their very nature, are subject to risks and uncertainties, including, among other factors, market conditions, competitive dynamics, the level of acceptance of new products, and the effective execution of the planned initiatives. Although there is inherent uncertainty in this type of projections, the execution of the strategic plan and its milestones are progressing as expected, without any significant deviations. Consequently, management has estimated future cash flows for the period 2026 – 2034.
For the calculation of the recoverable amount, management has considered:
Cash flows estimated as of the year in which stable growth in the CGU has been reached are extrapolated using the estimated growth rates indicated below. Perpetual growth rates are consistent with the forecasts included in industry reports.
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The proportion of the recoverable amount corresponding to the discounted cash flows during the projection period, as well as to the terminal value, is shown below:
Explicit Cash Flows
Terminal Value
Recoverable Amount
The recoverable amount of the GigaGen CGU has been determined based on the fair value less costs to sell, calculated as the present value of the future cash flows mainly of a research and development project that have been approved by management, adjusted by the probability of success and discounted at a discount rate that includes their inherent risk (Level 3 in the fair value hierarchy). Cash flows have been estimated taking into consideration a useful life of 20 years from the product launch.
The recoverable amount of Alkahest CGU has been determined based on the fair value less costs to sell, calculated as the present value of the future cash flows mainly of three research and development project that have been approved by management (see caption iv of this note), adjusted by the probability of success and discounted at a discount rate that includes their inherent risk (Level 3 in the fair value hierarchy). Cash flows have been estimated taking into consideration a useful life of 20 years from the product launch.
iii) Key assumptions
The key assumptions used in calculating impairment testing of the CGUs for 2025 have been as follows:
Perpetual Growth rate
Pre-tax discount rate
11.2
1.6
11.8
GigaGen
N/A
17.9
Alkahest
25.9% - 39.8
Additionally, the following key assumptions have been used for the GigaGen and Alkahest CGU impairment testing in 2025:
Success rate
20.0
12.0
Likewise, for the impairment test of the Diagnostic CGU in 2025, the sales of Molecular Donor Screening (MDS), Blood Typing Solution (BTS) and those of the Clinical Diagnostic (CDx) have been considered as key assumptions based on the information regarding sales and EBITDA of the CGU detailed below:
CAGR
sales
EBITDA
2025-2030
2030-2034
The discount rate used reflects specific risks relating to the CGUs and the countries in which they operate. The main assumptions used for determining the discount rate are as follows:
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The key assumptions used in calculating impairment testing of the CGUs for 2024 were as follows:
11.4
10.6
11.6
NA
Additionally, the following key assumptions were used for the GigaGen and Alkahest CGU impairment testing in 2024:
Sink rate
5.0
12.0% - 17.0
In 2025, the sink rate is no longer considered a key assumption in the impairment test for GigaGen, as its effect on the recoverable amount is not significant. This is because the sink rate assumption applies only in later periods of the projection horizon, after a substantial portion of the investment has already been recovered through earlier projected cash flows.
Likewise, for the impairment test of the Diagnostic CGU in 2024, the sales of Molecular Donor Screening (MDS), Blood Typing Solution (BTS) and those of the Clinical Diagnostic (CDx) were considered as key assumptions based on the information regarding sales and EBITDA of the CGU detailed below:
2024-2029
2029-2034
iv) Impairment loss
In 2025, an impairment loss on the goodwill of the Alkahest CGU was recognized for an amount of Euros 10 million as a result of a change in the strategic priorities approved by management (Note 7).
v) Sensitivities analyses
In 2025, and according to the current economic context, the reasonably possible changes considered for the CGUs impairment testing are a variation in the discount rate, as well as in the estimated perpetual growth rate, with independent movements of each other, as follows:
+/- 50 bps
+/- 100 bps
+/- 200 bps
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Additionally, for the impairment test of the Diagnostic CGU for the year 2025, the following sensitivity scenarios to variations in sales of the MDS, BTS and CDx business lines have also been considered:
The reasonably possible changes in key assumptions considered by management in the calculation of the recoverable amount of the Biopharma and Bio Supplies CGU’s would not cause the carrying amount to exceed its recoverable amount.
The reasonably possible changes in key assumptions considered by management in the calculation of the different CGU recoverable amount that would cause the carrying amount to exceed its recoverable amount are as follows:
% Potential Impairment over Asset Value
Discount rate sensitivity Kiro +50bps
-4
Perpetual growth rate sensitivity Kiro -50bps
-2
Discount rate sensitivity GigaGen +200 bps
-13
Aggregate sensitivity scenario to MDS, BTS and CDx sales
-11
Discount rate sensitivity Alkahest +200bps
Detail of the assets by segment value is shown in Note 5.
Since reasonably possible changes in certain key assumptions used by management in determining the recoverable amount for Kiro Grifols, Gigagen, Diagnostic and Alkahest CGUs would result in the carrying amount exceeding the respective recoverable amount, the following information is provided:
Amount by which the recoverable amount exceeds the carrying amount
Perpetual growth rate
Pre-tax discount rate at which the recoverable equals the carrying amount
Perpetual growth rate at which the recoverable equals the carrying amount
18.8
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14.0
Sales and EBITDA CAGR (2025-2034)
7.7% / 15.3
Sales and EBITDA CAGR (2025-2034) at which the recoverable amount equals the carrying amount
6.6% / 13.5
15.0
26% - 40
27% - 41
In 2024, the reasonably possible changes considered for the CGUs impairment testing were a variation in the discount rate, as well as in the estimated perpetual growth rate, with independent movements of each other, as follows:
Additionally, for the impairment test of the Diagnostic CGU for the year 2024, the following sensitivity scenarios to variations in sales of the MDS, BTS and CDx business lines were also considered:
In addition, the following reasonably possible change for the year 2024 was considered for the GigaGen CGU impairment testing:
In 2024, the reasonably possible changes in key assumptions considered by management in the calculation of the different CGU recoverable amount that would have caused the carrying amount to exceed its recoverable amount were as follows:
-5
-7
-10
-17
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In 2024, since reasonably possible changes in certain key assumptions used by management in determining the recoverable amount for Kiro Grifols, Gigagen, Diagnostic and Alkahest CGUs would have resulted in the carrying amount exceeding the respective recoverable amount, the following information is provided:
18.2
15.8
Sales and EBITDA CAGR (2024-2034)
7.2% / 12.8
Sales and EBITDA CAGR (2024-2034) at which the recoverable amount equals the carrying amount
6.0% / 10.7
9.3
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(7)Other Intangible Assets
Changes in Other Intangible Assets for the year ended 31 December 2025 and 2024
Millions of euros
Concessions,
Currently
Impairment of
Development
patents, licenses
Computer
marketed
Other intangible
other intangible
costs
brands & similar
software
products
assets
Cost
Balance at 31/12/2023
1,853
285
360
1,389
4,003
Additions
Transfers
Total Cost at 31/12/2024
2,003
401
1,463
4,284
Acc. Amortization
(229)
(499)
(1,171)
(33)
(34)
(49)
(133)
Total Acc Amort at 31/12/2024
(267)
(112)
(294)
(1,358)
Carrying amount
Total at 31/12/2024
1,736
884
Balance at 31/12/2024
(35)
(103)
(143)
(313)
Total Cost at 31/12/2025
2,007
272
409
1,320
(47)
4,081
Total Acc Amort at 31/12/2025
(113)
(564)
(96)
(1,353)
Total at 31/12/2025
1,721
756
Intangible assets acquired from Talecris mainly include currently marketed products. Identifiable intangible assets correspond to Gamunex and have been recognized at fair value at the acquisition date of Talecris and classified as currently marketed products. Intangible assets recognized comprise the rights on the Gamunex product, its commercialization and distribution license, trademark, as well as relations with hospitals. Each of these components is closely linked and fully complementary, are subject to similar risks and have a similar regulatory approval process.
The intangible assets acquired from Biotest AG mainly include the acquired product portfolio. The identifiable intangible assets correspond to the plasma therapies segment and have been recorded at fair value at the date of acquisition of Biotest and classified as an acquired product portfolio.
The intangible assets acquired from Access Biologicals LLC mainly include customer relationships. This asset has been recorded at fair value at the date of acquisition of Access Biologicals LLC and classified as acquired customer relationships.
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The estimated useful life of the currently marketed products acquired from Talecris is considered limited, has been estimated at 30 years on the basis of the expected life cycle of the product (Gamunex) and is amortized on a straightline basis.
At 31 December 2025, the residual useful life of currently marketed products is 15 years and 5 months (16 years and 5 months at 31 December 2024).
The estimated useful life of the product portfolio acquired from Biotest AG is considered limited and has been estimated at 30 years, based on the expected life cycle of the products. The amortization method is linear.
At 31 December 2025, the residual useful life of product portfolio acquired from Biotest AG is 26 years and 4 months (27 years and 4 months at 31 December 2024).
The estimated useful life of the customer relationships acquired from Access Biologicals LLC is considered limited and has been estimated at 14 years, based on the rate of decline of the same. The amortization method is linear.
At 31 December 2025, the residual useful life of the customer relationships acquired from Access Biologicals LLC is 10 years and 6 months (11 years and 6 months at 31 December 2024).
Internally-developed intangible assets
At 31 December 2025 the Group has recognized Euros 118 million as self – constructed intangible assets (Euros 107 million at 31 December 2024) in the consolidated profit and loss account.
b)
Purchase commitments
At 31 December 2025 the Group has intangible purchase commitments for Euros 41 million euros.
c)
Intangible assets in progress
At 31 December 2025, the Group has an amount of Euros 1,494 million as development costs in progress (Euros 1,472 million at 31 December 2024). This amount includes an amount of Euros 267 million as of 31 December 2025 (Euros 302 million as of 31 December 2024) corresponding to the ongoing research and development projects for products for neurodegenerative disorders and neuromuscular diseases acquired from Alkahest. Likewise, there is also an amount of Euros 895 million as of 31 December 2025 (Euros 879 million as of 31 December 2024) corresponding to the ongoing research and development projects in plasma therapies acquired from Biotest AG (Fibrinogen and Trimodulin).
d)
Results on disposal of intangible assets
The total losses on disposals and sale of intangible assets amounts to Euros 1 million in 2025 (no impact in 2024).
e)
Impairment testing
Indefinite-lived intangible assets have been allocated to the corresponding cash-generating unit (CGU). These assets have been tested for impairment together with goodwill (see note 6).
Impairment testing has been analyzed for each of the intangible assets in progress by calculating its recoverable amount based on their fair value based on the discount of free cash flows adjusted by the probability of success according to the clinical phase of the project.
In 2025, the Group recognized an impairment loss of Euros 35 million related to the full carrying amount of an ongoing research and development (R&D) project for a product targeting ophthalmologic disorders originally acquired from Alkahest, as a result of a change in the strategic priorities approved by management.
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(8)Leases
Details of changes in leases for the year ended 31 December 2025 and 2024 are as follows.
Land and Buildings
Machinery
Computer equipment
Vehicles
1,216
1,250
1,325
1,363
(283)
(305)
(75)
(83)
(368)
957
(41)
(126)
Balance at 31/12/2025
1,302
1,330
(74)
(82)
(385)
(398)
917
Details of leases in the consolidated balance sheet at 31 December 2025 and 2024 are as follows:
Right-of-use assets
Land and buildings
Lease liabilities
Non-current
969
1,025
Current
1,082
1,142
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The composition of lease liabilities as of 31 December 2025 and 2024 is shown below. Undiscounted future payments classified on a maturity basis are presented together with the effect of the financial discount:
Maturity:
Within one year
In the second year
In the third to fifth years
296
After the fifth year
1,221
1,713
1,774
Discounting effect
(631)
Total lease liabilities
At 31 December 2025, the Group has recognized an amount of Euros 143 million related to additions of right-of- use assets (Euros 80 million at 31 December 2024).
At 31 December 2025 and 2024, the amounts recognized in the consolidated statement of profit and loss related to lease agreements are:
Right-of-use depreciation
Finance lease expenses
Expenses related to short-term contracts
Expenses related to low-value contracts
Other operating lease expenses
At 31 December 2025, the Group has paid a total of Euros 119 million related to lease contracts (Euros 111 million at 31 December 2024).
The total amount recognized in the consolidated balance sheet corresponds to lease contracts in which the Group is the lessee.
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(9)Property, Plant and Equipment
Movement in Property, Plant and Equipment for the year ended 31 December 2025 and 2024.
Impairment of other
Fixed Assets under
property, plant and
Plant and machinery
construction
equipment
1,132
3,175
5,211
259
(78)
263
(323)
1,231
3,554
802
5,580
(206)
(1,758)
(1,964)
(191)
(222)
(85)
(246)
(1,992)
(2,238)
985
1,562
227
286
(50)
(51)
(226)
(264)
(77)
(434)
1,209
3,450
726
5,377
(207)
(240)
(257)
(2,000)
(2,257)
952
1,450
Property, plant and development under construction at 31 December 2025 and 2024, mainly comprise investments made to extend the companies’ equipment and to increase their productive capacity.
In 2025 the Group has capitalized interests for a total amount of Euros 22 million (Euros 28 million in 2024) (note 25).
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Insurance
Group policy is to contract sufficient insurance coverage for the risk of damage to property, plant and equipment. At 31 December 2025, the Group has a joint insurance policy covering all the Group’s companies and locations.
Losses on disposal of property, plant and equipment
Total losses incurred on disposals of property, plant and equipment for 2025 amount to Euros 1 million (losses of Euros 3 million in 2024).
Self - constructed property, plant and equipment
At 31 December 2025 the Group has recognized Euros 74 million as self -constructed property, plant and equipment (Euros 63 million at 31 December 2024) in the Consolidated Statements of Profit and Loss.
At 31 December 2025, the Group has property, plant and equipment purchase commitments amounting to Euros 44 million.
Property, plant and equipment under construction
Property, plant and equipment under construction as of 31 December 2025 amount to Euros 726 million (Euros 802 million in the 2024) and mainly correspond to the investments incurred in the expansion of the facilities of the companies and their productive capacity in the United States, Canada, and Ireland (Note 29).
f)
As of December 31, 2025 and 2024 the Group has recognized an impairment loss amounting to Euros 1 million.
(10)Equity-Accounted Investees and Joint Business
Details of this caption in the consolidated balance sheet at 31 December 2025 and 2024 are as follows:
% ownership (*)
Grifols Egypt for Plasma Derivatives S.A.E.
49.00
BioDarou P.J.S. Co.
39.40
34.30
Grifols Canada Plasma, Inc.
Total equity - accounted investees
(*) This percentage also refers to the voting interest.
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Movement in the investments in equity-accounted investees for the year ended 31 December 2025 is as follows:
Equity accounted investees with similar activity to that of the Group
Grifols Egypt for
Plasma Derivatives
Grifols Canada
S.A.E.
Plasma, Inc.
Balance at 1 January
Share of profit / (losses)
Share of other comprehensive income / translation differences
Collected dividends
Impairment loss
Balance at 31 December
Movement in the investments in equity-accounted investees for the year ended 31 December 2024 is as follows:
Rest of equity accounted investees
Grifols Egypt
Blood Products
for Plasma
BioDarou
Co., Ltd.
Derivatives S.A.E.
P.J.S. Co.
361
Uncollected dividends
(367)
(370)
Additionally, as a result of the sale of SRAAS in 2024, an operating profit of Euros 34 million was generated, which was recorded under the heading ‘Profit of equity accounted investees with similar activity to that of the Group’ in the attached 2024 Consolidated Statements of Profit and Loss.
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Movement in the investments in equity-accounted investees for the year ended 31 December 2023 is as follows:
Albajuna
Therapeutics,
Mecwins,
S.L
S.A.
1,453
1,494
1,498
(1,090)
The main movements of the equity-accounted investees with similar activity to that of the Group are explained below:
On November 1, 2025, the Group acquired 50.10% of the share capital of Canadian Plasma Resources Corporation (CPR), a private Canadian company engaged in plasma collection for the manufacture of plasma-derived therapies. The transaction was executed through the subscription of new shares for an approximate amount of Canadian Dollars 27 million (Euros 19 million), including costs directly attributable to the transaction. After the transaction, the company has been renamed Grifols Canada Plasma, Inc.
Nevertheless, notwithstanding the majority shareholding acquired, the governance structure and the contractual arrangements in place restrict Grifols’ ability to control Grifols Canada Plasma, Inc. In particular:
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Consequently, even though Grifols holds a majority interest in the share capital, it does not have power over the relevant activities, cannot unilaterally direct the financial and operating policies, and does not control the governing bodies. Therefore, the investment in Grifols Canada Plasma, Inc. is accounted for using the equity method, as Grifols has the ability to exercise significant influence over decisions relating to financial and operating policies.
As part of the acquisition agreement of Grifols Canada Plasma, Inc., the Group, through GWWO, has granted a loan intended to finance operating needs and facilitate the transition until full acquisition. The initial amount of the loan was Canadian Dollar 2 million, disbursed in the first phase of the agreement in November 2025. This loan is designed to increase progressively based on Grifols Canada Plasma, Inc. operating activity. The mechanism provides for additional drawdowns calculated monthly according to the volume of plasma collected. At year-end, the outstanding balance amounts to Canadian Dollar 3 million (Euros 2 million).
Grifols Egypt for Plasma Derivatives (S.A.E.)
On 29 July 2021, a cooperation agreement was signed with the Egyptian company National Service Projects Organization (“NSPO”) to incorporate a new entity in Egypt. The aim of this alliance is to help build a platform to bring self-sufficiency in plasma-derived medicines in the country through the construction and operation of 20 plasma collection centers, a fractionation plant, and a protein purification and dosing plant.
Grifols and NSPO hold 49% and 51% respectively in the new entity. The agreement includes a call option and a put option for both shareholders which allows them to acquire or sell their entire stake to the counterparty (Note 29(c)).
The Group made a first contribution of US Dollars 37 million (equivalent to Euros 30 million at the date of integration), and in exchange received Grifols Egypt for Plasma Derivatives (S.A.E.) shares representing 49% of its share capital, which would initially amount to US Dollars 300 million. The Company undertook to make the contributions for the outstanding amount corresponding to its interest as the capital requirements were approved. As a result, the Group made a further capital contribution of US Dollars 22 million during 2025 (US Dollars 44 million in 2024 and US Dollars 22 million in both 2023 and 2022, respectively), equivalent to 49% of the total capital capital increase made. Thus, the total contributions made by the Group amount to US Dollars 147 million as of December 31, 2025, equivalent to 49% of its share capital, which total amounts is US Dollar 300 million.
Under the planned investment program, the company has committed to additionally contribute US Dollar 44 million in 2026, US Dollar 39 million in 2027, and US Dollar 15 million in 2028.
Shanghai RAAS Blood Products Co. Ltd.
As a result of the sale in 2024 of the 20% equity interest in Shanghai RAAS (SRAAS), which had previously been reclassified as a non‑current asset held for sale in 2023 in accordance with IFRS 5, the Group recognized net proceeds associated with the transaction amounting to Euros 1,564 million, after settling the corresponding taxes in China.
The transaction was accompanied by the arrangement of a EUR/RMB foreign exchange forward contract, which was not designated as an accounting hedge. As a result, the funds received amounted to Euros 1,560 million, with a foreign‑exchange loss of Euros 18 million and a gain of Euros 13 million arising from the financial instrument entered into being recognized simultaneously (Note 25).
Accordingly, Grifols lost its significant influence over its investment in SRAAS, and the remaining 6.58% interest in SRAAS shares is considered a financial asset measured at fair value through Other Comprehensive Income. Its fair value at the transaction date was determined based on the quoted market price of SRAAS shares on that date. In addition, Grifols lost its indirect ownership interest in GDS previously held through its investment in SRAAS, which resulted in an increase of Euros 508 million in equity attributable to non‑controlling interests.
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This transaction did not have a material impact on the Consolidated Statements of Profit and Loss for 2024 and is calculated as follows:
Million of euros
Selling price
1,608
Fair value of SRAAS 6.58%
434
Minus: book value of the Non-current asset held for sale and transaction costs
(1,124)
Minus: book value of the Investment accounted for using the equity method as the date of loss of the significant influence
Minus:increase of the minority interest of GDS (see Note 19)
(508)
Other contractual obligations (see Note 29)
Result before the reclassification of translation differences
Accumulated translation differences in equity
Transaction result: profit
Taxes on profits in China and Spain
Result net of taxes
The result of the transaction includes an unrealized gain corresponding to the revaluation of the investment retained by Grifols in SRAAS at fair value in the amount of Euros 68 million.
On 25 April 2022, and after obtaining all regulatory approvals, Grifols closed the acquisition of 70.18% of the share capital of Biotest AG for Euros 1,461 million (note 3). Biotest AG is the parent company of a consolidated group of companies, which includes a joint venture investment corresponding to a 49% interest held by Biotest Pharma GmbH in BioDarou P.J.S. Co, whose registered office is in Tehran, Iran, and which is accounted for using the equity method.
The company’s goal is to collect plasma, process it into immunoglobulins, factors and human albumin through Biotest AG and then sell the finished products in Iran.
Albajuna Therapeutics, S.L.
In 2016, Grifols made a capital investment of Euros 4 million in exchange for 30% of the shares of Albajuna Therapeutics, S.L. Since 2018, as a result of a planned investment in accordance with the Shareholders’ Agreement of January 2016, Grifols held a 49% stake in the company’s capital. Albajuna Therapeutics, S.L. is a Spanish research company founded in 2016 which main activity is the development and manufacture of therapeutic antibodies against HIV.
On 9 October, 2023, Grifols, through its 100% owned subsidiary Grifols Innovation and New Technologies Limited, reached an agreement to acquire all the shares of Albajuna Therapeutics, S.L. for the remaining 51% for a total amount of Euro 1. With the acquisition of 100% of the shares, Grifols obtained control over Albajuna Therapeutics, S.L. and, therefore, it has become a group company and is consolidated (note 3).
On 22 October 2018 Grifols allocated Euros 2 million to the capital increase of Mecwins through Progenika Biopharma, reaching 24.99% of the total capital.
Mecwins is a spin-off of the Institute of Micro and Nanotechnology of the Center for Scientific Research (CSIC), specialized in the development of innovative nanotechnological analysis tools for the diagnosis and prognosis of diseases.
Mecwins has developed ultrasensitive optical reading immunoassay technology from nanosensors for the detection of protein biomarkers in blood. This technology has potential applications in fields such as oncology, cardiovascular and infectious diseases.
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The injection of capital, in which CRB Inverbio also participated with an additional Euros 2 million, enabled Mecwins to start developing pre-commercial prototypes of this technology and for Grifols to position itself in the field of nanotechnology applied to diagnosis.
In 2021, Mecwins, S.A. acquired own shares from Progenika Biopharma, S.A. to generate treasury stock. This acquisition caused the percentage of ownership in Mecwins, S.A. to decrease to 24.59%.
As of December 31, 2024, since the group ceased to exercise significant influence because it no longer had representation on the Board of Directors and could not intervene in financial policy decisions or its operation, the investment was reclassified as a financial asset with changes in “Other Comprehensive Income” (note 11).
The most recent financial statements available of the main equity-accounted investments of Grifols are as follows:
Balance sheet:
Non-current assets
Current assets
Non-current liabilities
Current liabilities
(46)
Net assets
P&L:
Blood Products Co.,
Ltd.
778
Net profit
234
Joint arrangement:
Biotek America, LLC
Grifols entered into a collaboration agreement with ImmunoTek GH, LLC (“ImmunoTek”) for the opening and management of 28 plasma collection centers. The transaction was executed through the creation of Biotek America LLC (“ITK JV”), which created a series of shares for each center (silos). Grifols held 75% of each series of shares, and ImmunoTek held the remaining 25%. Approximately three years after the opening of each center, according to the agreement, Grifols would acquire the collection centers.
As of December 31, 2025, Grifols has completed the acquisition of all plasma centers, which are now managed through the Group’s subsidiary Biomat Holdings LLC, thereby concluding the collaboration agreement and, consequently, the joint operation (Note 3).
The collaboration agreement between the Group and Immunotek has involved, as of December 31, 2025 and 2024:
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The amounts paid net of deposits and on the basis of a minimum production and existence of the centers at the time of purchase, were the following (note 3):
Millions
US Dollar
Euros
Group 3
Group 4
Until the acquisition date of the centers and the completion of the collaboration agreement, regardless of whether Grifols held a 75% stake and whether the management was transferred to ImmunoTek, there was joint control until Grifols acquired the centers and would be accounted for as a joint operation based on the contractual conditions: (i) joint decision-making power on the relevant activities; (ii) Grifols’ exposure to the 75% stake, the advances paid, the guarantees granted and the contracts for the purchase of plasma supply; (iii) significant exposure of the other shareholder to the results of the silos generated and their fees, given that it did not act with delegated power and, (iv) relation between the two.
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Therefore, to the extent that there was joint control and each series was representative of a silo and was designed and created to sell all the plasma collected to Grifols, which advanced the necessary funds for the development of the series and guaranteed the obligations, they should be considered joint agreements. However, there was a disproportion between Grifols’ percentage stake in the series, which amounted to 75%, and the economic exposure to assets and liabilities of 100%, while the income and expenses and tax benefits derived therefrom from the period prior to the acquisition were attributed to ImmunoTek. As a result, the losses generated by the series during the period prior to the acquisition were attributed to the other shareholder under the tax transparency regime.
Below is a breakdown of the aggregate balances of the centers as of 31 December 2024, excluding balances with Grifols:
US Dollars
Grifols’ balances
Total Equity
(11)Financial Assets
Details of non-current financial assets on the consolidated balance sheet at 31 December 2025 and 2024 are as follows:
Other non-current investments
422
Non-current derivatives
Total Non-current financial assets measured at fair value
Non-current guarantee deposits
Other non-current financial assets
Non-current loans
Total Non-current financial assets measured at amortized cost
Total Non-current financial assets
In Non-current guarantee deposits, there are long-term deposits with related parties that amount Euros 1 million at 31 December 2025 (Euros 1 million at 31 December 2024) (note 31). Additionally, there is a pledged deposit amounting to US Dollars 10 million, which forms part of the US Dollar 50 million guarantee granted by the Group to Grifols Egypt for Plasma Derivatives S.A.E., securing a contract entered into by said entity with a financial institution (see note 31).
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The remaining 6.58% interest in SRAAS shares is included under “Other non-current investments”. This investment has been considered a financial asset measured at fair value with changes in ‘Other Comprehensive Income of financial investments’ whose fair value has been calculated on the basis of the SRAAS share price at that date (CNY 6.34 per share at 31 December 2025 and CNY 7.22 per share at 31 December 2024) in the amount of Euros 336 million at 31 December 2025 (Euros 416 million at 31 December 2024) recognizing a loss under the heading of other comprehensive income in 2025 of Euros 80 million net of tax (Euros 18 million in 2024).
Details of current financial assets on the consolidated balance sheet at 31 December 2025 and 2024 are as follows:
Current derivatives
Deposits and guarantees
Current loans
Total other current financial assets measured at amortized cost
Total other current financial assets
a)Non-current and current loans
Details of non-current and current loans are as follows:
Loans to associates
Note 31
Loans to related parties
Loans to third parties
Total current and non-current loans
“Loans to related parties” includes by an amount of Euros 11 million (Euros 82 million as of 31 December 2024) the open balance of the cash pooling that Haema GmbH and BPC Plasma, Inc. have with Scranton Plasma B.V. (note 31). Despite their maturity date being 2027, these have been maintained in the short term as their recovery is expected through the collection of dividends in the coming year. In 2025, 2024 and 2023, BPC Plasma Inc. distributed to its shareholder Scranton Plasma B.V. a dividend without cash outflow compensating “Loans to related parties”. In 2025 the dividend amounted Euros 26 million (Euros 40 million in 2024, being the dividend distributed in 2023 the result of the previous 4 years for a value of Euros 266 million. This distribution had an impact against the Group’s non-controlling interests reserves (see note 17). Additionally, in 2025 Haema GmbH distributed to its shareholder Scranton Plasma B.V a dividend without cash outflow compensating “Loans to related parties” that amounted Euros 87 million.
Furthermore, through the execution of a quota transfer agreement on 31 October 2024, Grifols Worldwide Operations Limited (“GWWO”) as purchaser, acquired 100% of the share capital of Haema Plasma Kft, from Scranton Plasma B.V., as seller (the “SPA”), all of which in exchange of Euros 35 million (the “Purchase Price”). The Purchase Price was paid by GWWO to Scranton Plasma B.V. through the partial assignment by GWWO to Scranton Plasma B.V. of part of certain receivable held by GWWO against Haema GmbH (under certain advance payment made in the past by GWWO to Haema GmbH for the purchase of plasma (the “Plasma Advance Receivable”)) in the amount of the Purchase Price (the “Assigned Receivable”). Therefore, the amount of the Plasma Advance Receivable was reduced in the amount of the Assigned Receivable. In turn and in addition, upon receipt by Scranton Plasma B.V. of the Assigned Receivable, Scranton Plasma B.V., as creditor under the Assigned Receivable against Haema GmbH, as debtor thereunder, settled its debt position under the cash-pooling financing agreement in the amount of the Assigned Receivable (and hence, the amount outstanding under the cash-pooling arrangement between Haema GmbH, as creditor and Scranton Plasma B.V., as debtor, was reduced in the amount of the Assigned Receivable).
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Additionally, this caption includes the loan granted to Scranton Enterprises BV by the Group related to the payment of the sale of the shares of BPC Plasma, Inc. and Haema, GmbH (notes 21 and 31). The initial amount of the loan was US Dollars 95 million (Euros 87 million). Furthermore, in 2023 an additional amount of Euros 15 million was drawn under the same terms as the original loan. As of 31 December 2025, the recorded amount stands at Euros 124 million, including accrued and capitalized interest to date (Euros 132 million as of 31 December 2024).
As part of the acquisition agreement of Grifols Canada Plasma, Inc., the Group has granted a loan which amounts Canadian Dollar 2 million (see Note 10).
Details of inventories at 31 December 2025 and 2024 are as follows:
Goods for resale
Raw materials and supplies
936
979
Work in progress and semi-finished goods
1,407
1,478
Finished goods
862
1,059
Allowance for slow-moving and obsolete inventory
(150)
Grifols maintains insurance policies to mitigate potential risks of material damage to inventories.
Movement in the inventory provision was as follows:
Net charge for the year
Cancellations for the year
The Group has entered into unconditional purchase commitments in the ordinary course of business. These commitments include legally binding agreements to acquire goods, which specify all relevant terms such as: fixed or minimum quantities to be purchased, fixed, minimum or variable pricing conditions, and the approximate timing of the transaction. Agreements that can be cancelled at any time without penalty are excluded from these commitments. The total amount of the Group’s unconditional purchase commitments is as follows:
427
2028
346
2029
295
2030
More than 5 years
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Details at 31 December 2025 and 2024 are as follows:
619
687
Receivables from associates
Impairment losses
Note 30 (c)
Personnel
Advance payments
Taxation authorities, VAT recoverable
Other public entities
Total current contract assets, trade and other receivables
872
Short‑term contract assets relate to outstanding performance obligations arising from installment agreements entered into by certain Group companies. These contractual obligations are generally settled within a period of less than 12 months. Trade receivables arising from this line of business, which generally have maturities ranging from 60 to 120 days, are recognized when the right to consideration becomes unconditional. This occurs at the time when biological drugs produced from plasma provided by the customer are delivered to the customer. These transactions are measured at cost of sales plus margin, provided that such margin can be reliably estimated.
Credit risk is recognized through valuation adjustments to contract assets. The allowance for doubtful accounts is determined as the difference between the nominal value of contract assets and the estimated recoverable amount.
The following represent the carrying amount of the trade and other receivables and contractual assets categorized by due date as of 31 December 2025 is as follows:
Total gross carrying
Total net third party
ECL Rate
amount
Provision
trade receivables
Not matured
0.19
522
521
Past due 0-30 days
Past due 31-60 days
0.62
Past due 61-90 days
2.03
Past due 91-180 days
3.01
Past due 181-365 days
8.52
More than one year
Customers with objective evidence of impairment
757
734
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The following represent the carrying amount of the trade and other receivables and contractual assets categorized by due date as of 31 December 2024 is as follows:
622
621
762
741
Movement in the bad debt provision was as follows:
Opening balance
Net charges for the year
Net cancellations for the year
Closing balance
The Group also records impairment allowances representing the best estimate of expected losses on trade receivables and other accounts receivable. For trade receivables, the simplified approach is applied, estimating expected losses over the entire life of the asset, while for other financial assets the general model is used. Monitoring of portfolios without specific signs of impairment is performed using a provision matrix based on ageing. For trade receivables related to Middle Eastern customers overdue for more than one year, the matrix percentages have been adjusted to reflect specific default patterns. For other financial assets, the Group has assessed their recoverability and concluded that there is no significant risk of default. These allowances are based on historical experience and the ageing of balances, and are reviewed periodically to reflect changes in risk. Thanks to the strong credit quality of customers and the fact that collection periods are generally short, around 30 days, the impact of these allowances has not been significant.
Assignment of credit rights
During 2025, 2024 and 2023, the Group has sold receivables without recourse to some financial institutions (factors), to which the risks and benefits inherent to the ownership of the assigned credits are substantially transferred. Also, the control over the assigned credits, understood as the factor’s ability to sell them to an unrelated third party, unilaterally and without restrictions, has been transferred to the factor.
The main conditions of these contracts include the advanced collection of the assigned credits that vary between 70% and 100% of the nominal amount and a percentage of insolvency risk coverage on the factor side that varies between 90% and 100% of the nominal of the assigned credits. These contracts have been considered as without recourse factoring and the amount advanced by the factors has been derecognized from the balance sheet.
At 31 December 2025, the finance cost of credit rights sold for the Group totals Euros 14 million which has been recognized under finance costs in the consolidated statement of profit and loss for (Euros 31 million in 2024 and Euros 25 million in 2023) (note 25).
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The volume of net invoices that have been sold without recourse to various financial institutions which would not have been collected as of 31 December 2025, totals Euros 325 million (Euros 312 million at 31 December 2024).
Details of balances with related parties are shown in note 31.
Details of this caption of the consolidated balance sheet at 31 December 2025 and 2024 are as follows:
Current deposits
Restricted cash
Cash in hand and at banks
793
975
Total cash, cash restricted and cash equivalents
As of 31 December 2025, there is a restricted amount of 24 millions of euros in a Group bank account, respect of which the financial institution maintains an administrative operational restriction. This restriction neither affects the Group´s legal title to the cash nor changes its nature, but rather arises from the bank´s internal approval procedures as part of its standard banking operations.
The Group continuously monitors its exposure to these restrictions and considers that they do not significantly impact its overall liquidity position or its ability to meet short-term financial obligations.
Details of consolidated equity and movement are shown in the consolidated statement of changes in equity.
At 31 December 2025 and 2024, the Company’s share capital amounts to Euros 119,603,705 and comprises:
Our Class B shares have substantially similar dividend and other economic rights as our Class A shares, but differ from the Class A shares in some important respects that are outlined below.
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Each of our Class B shares entitles its holder to receive a minimum annual preferred dividend out of the distributable profits at the end of each fiscal year the share is outstanding equal to Euros 0.01 per Class B share. In any given fiscal year, we will pay a preferred dividend to the holders of our Class B shares before any dividend out of the distributable profits for such fiscal year is paid to the holders of our Class A shares. The preferred dividend on all issued Class B shares will be paid by us within the nine months following the end of that fiscal year, in an amount not to exceed the distributable profits obtained by us during that fiscal year.
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Payment of the redemption price will be subject to us having sufficient distributable reserves but, after a tender offer occurs and until the redemption price for our Class B shares is paid in full, we will not be able to declare or pay any dividends nor any other distributions to our shareholders (in each case, whether in cash, securities of Grifols or any of our subsidiaries, or any other securities,assets or rights).
F-75
As an exception, the preferential subscription rights and the free allotment rights of the Class B shares will only be for new Class B shares or for instruments giving the right to purchase, convert, subscribe for or otherwise receive Class B shares, and the preferential subscription right and the free allotment right of an Class A share will only be for new Class A shares or for instruments giving the right to purchase, convert, subscribe or otherwise receive Class A shares, for each capital increase or issuance that meets the following three requirements: (i) the issuance of Class A shares and Class B shares is in the same proportion of our share capital as they represent at the time the resolution on the capital increase is passed; (ii) grants of preferential subscription rights or free allotment rights,as applicable, to the Class B shares for the Class B shares are under the same terms as the preferential subscription rights or free allotment rights, as applicable, granted to the Class A shares for the Class A shares; and (iii) no other shares or securities are issued.
Class B shares are in book-entry form on Iberclear and are indivisible, in the same terms as the Class A shares.
Since 23 July 2012 the ADSs (American Depositary Shares) representing Grifols’ Class B shares (non-voting shares) have had an exchange ratio of 1:1 in relation to Class B shares, ie.1 ADS represents 1 Class B share. The previous rate was 2 ADS per 1 Class B share.
The Company’s knowledge of its shareholders is based on information provided voluntarily or in compliance with applicable legislation (note 15(g)).
At 31 December 2025 and 2024, the number of outstanding shares is equal to the total number of Company shares, less treasury stock.
Movement in outstanding shares during 2025 is as follows:
Class A shares
Class B shares
Balance at 1 January 2025
422,185,368
258,223,736
(Acquisition) / disposal of treasury stock
166,208
422,351,576
Movement in outstanding shares during 2024 is as follows:
Balance at 1 January 2024
256,906,911
1,316,825
Movement in the share premium is described in the consolidated statement of changes in equity, which forms an integral part of this note to the consolidated financial statements.
The drawdown of accumulated gains is subject to legislation applicable to each of the Group companies.
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The movement in this caption of the consolidated balance sheet during the years ended at 31 December 2025, 2024 and 2023 is reflected in the consolidated statement of changes in equity.
In the current fiscal year, the most significant movements mainly correspond to the acquisitions of Biotest AG and Araclon Biotech (Note 17).
In 2024 the most significant movements relate to the acquisitions of Haema Plasma Kft, Grifols Pyrenees Research Center, S.L., and Grifols Malaysia SDN BHD (Note 2). The first one had a negative impact on reserves, decreasing them by Euros 14 million. On the other hand, the acquisition of Grifols Malaysia SDN BHD generated a positive effect, increasing reserves by Euros 5 million.
Legal reserve
Companies in Spain are obliged to transfer 10% of each year’s profits to a legal reserve until this reserve reaches an amount equal to 20% of share capital. This reserve is not distributable to shareholders and may only be used to offset losses if no other reserves are available. Under certain conditions it may be used to increase share capital provided that the balance left on the reserve is at least equal to 10% of the nominal value of the total share capital after the increase.
At 31 December 2025 and 2024 the legal reserve of the Parent amounts to Euros 24 million which corresponds to 20% of the share capital.
Distribution of the legal reserves of Spanish companies is subject to the same restrictions as those of the Company and at 31 December 2025 and 2024 the balance of the legal reserve of other Spanish companies amounts to Euros 2 million.
Other foreign Group companies have a legal reserve amounting to Euros 4 million at 31 de diciembre de 2025 and 2024.
Unavailable reserve
At 31 December 2025, Euros 30 million equivalent to the carrying amount of development costs pending amortization of certain Spanish companies (Euros 19 million at 31 December 2024) are, in accordance with applicable legislation, a distribution limitation until these development costs have been amortized.
Hedging reserve
The hedging reserve includes the cash flow hedge reserve and the costs of hedging reserve, see note 4(i) or details. The cash flow hedge reserve is used to recognize the effective portion of gains or losses on derivatives that are designated and qualify as cash flow hedges, as described in note 30.
The Group defers the changes in the forward element of forward contracts and the time value of option contracts in the costs of hedging reserve.
The Parent held Class A and B treasury stock equivalent to 1.02% of its capital at 31 December 2025 (1.04% of its capital in Class A and B treasury stock at 31 December 2024).
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Treasury stock Class A
Movement in Class A treasury stock during 2025 is as follows:
No. of Class A shares
3,944,430
Disposal Class A shares
(166,208)
3,778,222
During 2025, the Group delivered 166,208 treasury shares (Class A shares) to certain employees as compensation under the Restricted Stock Plan and the Long‑Term Incentive Plan.
During fiscal year 2024, there were no movements in Class A treasury shares, which remained at 3,944,430 shares and Euros 90 million.
Treasury stock Class B
During fiscal year 2025, there were no movements in Class B treasury shares, which remained at 3,201,374 shares and Euros 45 million.
Movement in Class B treasury stock during 2025 is as follows:
No. of Class B shares
3,201,374
Disposal Class B shares
Movement in Class B treasury stock during 2024 was as follows:
4,518,199
(1,316,825)
In April and October 2024, the Group delivered 1,316,825 treasury shares (Class B shares) to eligible employees as compensation under the Restricted Stock Plan.
Distribution of profit and dividends
The profits of Grifols, S.A. and subsidiaries will be distributed as agreed by respective shareholders at their general meetings.
F-78
The proposed distribution of profit of the Parent Grifols, S.A. for the years ended 31 December 2025, and the distribution of profit approved for 2024, presented at the general meeting held on June 5, 2025, is as follows:
Voluntary reserve
Results of the Parent
Distribution base:
Profit for the year
Distribution:
Mandatory preferred dividend for Class B shares
The distribution of profit corresponding to the year ended 31 December 2025 and 2024 presented in the statement of changes in consolidated equity.
On August 13, 2025, the Company paid an interim dividend for fiscal year 2025 amounting to a gross sum of 0.1500 euros per share, with the total distributed amount reaching Euros 102 million. The total dividend amount of Euros 158 million includes the Euros 102 million corresponding to the interim dividend already paid. The parent company has not distributed dividends in fiscal years 2023 and 2024.
f)Restricted Share Unit Retention Plan
The Group has set up a Restricted Share Unit Retention Plan (hereinafter RSU Plan) and a long-term incentive plan for certain employees (note 26).This commitment will be settled using equity instruments and the cumulative accrual amounts to Euros 13 million at 31 December 2025 (Euros 7 million at 2024).
The incentive plan that has been granted equity instruments to certain employees as part of their compensation package, subject to the achievement of various metrics, both financial and non-financial. The plan has been assessed by calculating the unit value of the options at the valuation date and multiplying it by the total number of options to be granted. Subsequently, this unit value will be adjusted based on the likelihood of achieving the specified objectives.
g)Significant shareholders
The most significant shareholdings in the share capital of Grifols, S.A. as of December 31, 2025, according to publicly available information or communication made to the Company, are as follows:
% of voting rights attached
% of voting rights through
to the shares
financial instruments
Name or company name of shareholder
Direct
Indirect
voting rights
Armistice Capital Master Fund Ltd
1.06
BlackRock, Inc.
3.38
0.90
4.27
Deria, S.L.
15.20
Flat Footed Llc.
3.13
Mason Capital Master Fund L.P.
3.17
7.09
Scranton Enterprises, B.V.
8.40
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Basic Earnings per share
The calculation of basic earnings per share is based on the profit for the year attributable to the shareholders of the Parent divided by the weighted average number of ordinary shares outstanding throughout the year, excluding treasury stock.
Details of the calculation of basic earnings per share are as follows:
Profit for the year attributable to shareholders of the Parent (Millions of Euros)
Weighted average number of ordinary shares outstanding
680,512,566
679,668,551
679,756,294
Basic earnings per share (Euros per share)
Basic earnings per share for Class A and B shares amounted to approximately Euros 0.59 and 0.60 per share, respectively.
The weighted average number of ordinary shares outstanding (basic) is as follows:
Number of shares
Issued shares outstanding at 1 January
680,409,104
679,092,279
679,469,076
Effect of treasury stock
103,462
576,272
287,218
Weighted average number of ordinary shares outstanding (basic) at 31 December
b)Diluted Earnings per share
Diluted earnings per share are calculated by dividing profit for the year attributable to shareholders of the Parent by the weighted average number of ordinary shares outstanding considering the diluting effects of potential ordinary shares.
The RSUs granted by the Group and payable in shares, assumes the existence of dilutive potential shares. Diluted earnings per share have been calculated as follows:
Weighted average number of ordinary shares outstanding (diluted)
681,573,145
679,916,715
677,101,992
Diluted earnings per share (Euros per share)
Diluted earnings per share for Class A and B shares amounted to approximately Euros 0.59 and 0.60 per share, respectively.
The weighted average number of ordinary shares outstanding diluted has been calculated as follows:
Ordinary shares outstanding at 1 January
Plans of rights over shares
1,060,579
248,164
(2,654,302)
Weighted average number of ordinary shares outstanding (diluted) at 31 December
F-80
Details of non-controlling interests and movement at 31 December 2025 are as follows:
Profit /
(loss) for
(Investments) /
the period
Divestments
movements
Grifols (Thailand) Pte Ltd
Haema GmbH
260
BPC Plasma, Inc
Grifols Diagnostic Solutions Inc.
1,970
1,781
Plasmavita Healthcare GmbH
Albimmune S.L.
Biotest AG
330
On March 7, 2025, Grifols, through its 100% owned subsidiary Grifols Innovation and New Technologies Limited, acquired 0.58% of the share capital of Araclon Biotech for a value of Euros 1 million. Additionally, on December 16, 2025, it acquired a further 0.69% interest for an amount of Euros10 million. As a result, as of December 31, 2025, the Group holds 77.12% of the company. The impact on reserves amounts to Euros 3 million and Euros 2 million in the non-controlling interests.
On February 14, 2025, Grifols acquired 589,694 non-voting preferred shares, representing approximately 1.5% of the share capital of Biotest AG at a price of €30.00 per share. The total amount disbursed by the Group amounts Euros 18 million. As a result of this transaction, the Group, directly and indirectly, became the owner of 71.68% of Biotest AG.
On March 31, 2025, Grifols Biotest Holdings GmbH announced its decision to make a delisting offer for the acquisition of all ordinary voting shares of Biotest AG (“Biotest”) at a price of €43.00 per share, as well as the non-voting preferred shares at a price of €30.00 per share, in accordance with the provisions of the Offer Document.
The acceptance period ended on June 6, 2025, the date from which Biotest AG’s shares ceased trading on the Frankfurt Stock Exchange.
The offer was accepted for a total of:
The total amount disbursed by the Group within the framework of this operation amounted to Euros 108 million.
As a result of the delisting offer, the Group, directly and indirectly through its subsidiary Grifols Biotest Holdings GmbH, came to hold:
F-81
The settlement of the offer was carried out on 16 June 2025.
Subsequently, in September and October 2025, the Group carried out several acquisitions. Grifols purchased 31,627 preferred shares, representing approximately 0.16% of the total non-voting preferred shares issued and 0.08% of Biotest AG’s share capital, at a price of €30.00 per share, as well as 549 ordinary voting shares at a price of €43.00 per share.
The total amount invested by the Group amounted to Euros 1 million. As a result of this transaction, the Group, directly and indirectly, came to hold 80.40% of Biotest AG’s share capital.
In accordance with the provisions of IFRS 10 – Consolidated Financial Statements, this transaction has been accounted for as a transaction with non-controlling interests, as the Group continues to exercise control over Biotest AG. Consequently, there has been no impact on the condensed interim consolidated income statement of the Group.
The impact of the transaction on the consolidated balance sheet as of 31 December 2025 is reflected in the following terms:
Additionally, in October 2025, the company Haema Plasma Kft. was sold to Biotest AG, leading to a further decrease in non-controlling interests of Euros 3 million.
In the fiscal year 2025, Haema GmbH and BPC Plasma Inc. distributed dividends amounting to Euros 87 million and Euros 26 million respectively without any cash outflow, as compensation for “Other loans with related parties” owed to its shareholder Scranton Plasma B.V. (notes 11 and 31).
Grifols Diagnostic Solutions Inc. has also distributed a dividend of US Dollar 70 million, having an impact against Group’s non-controlling reserves of Euros 27 million.
Details of non-controlling interests and movement at 31 December 2024 are as follows:
Grifols Malaysia Sdn Bhd
254
(40)
1,347
Haema Plasma Kft
Nota 2 (b)
357
484
On October 22, 2024, the Group acquired the entirety of Haema Plasma Kft., as detailed in note 2(b), which has resulted in a reduction of said non-controlling interest in its entirety.
F-82
Additionally, in the context of the agreement for the sale of the 20% stake in SRAAS, the effective percentage of the non-controlling interest in Grifols Diagnostic Solutions Inc. has increased by 11.96% reaching a 45%, representing an increase in the equity attributed to minority parties of Euros 508 million.
In 2024, Grifols Diagnostic Solutions Inc. has distributed a dividend of US Dollar 60 million, having an impact against Group’s non-controlling reserves of Euros 25 million. Furthermore, BPC Plasma, Inc. has made a distribution of dividends without cash outflow and in compensation for “Other loans to related parties” to its shareholder Scranton Plasma B.V. worth Euros 40 million (notes 11 and 31).
At 31 December 2025 and 2024, the main items of the statement of financial positions of the most significant non-controlling interests are as follows:
Total consolidated equity
(except for intercompany
% Non-controlling
liabilities
eliminations)
Interest
Grupo Biotest
2,195
876
(487)
(854)
1,041
Grupo GDS
4,197
251
(349)
3,958
239
6,836
1,206
(927)
(1,058)
5,324
2,310
2,130
780
(540)
(657)
1,105
29.8
4,627
4,378
230
240
(53)
7,227
1,180
(863)
5,889
2,706
% Non-
Non-
Ordinary
Net
controlling
Income
Biotest group
675
(72)
GDS Group
571
578
219
224
1,689
1,732
Detail of cash flows of the most significant non-controlling interests is as follows:
Milions of Euros
BPC Plasma
Biotest Group
Net cash flows from operating activities
(120)
Net cash flows from investing activities
Net cash flows from financing activities
(160)
F-83
Haema GmbH and BPC Plasma, Inc.
In mid-2018, Grifols acquired 100% of the shares of Haema GmbH (formerly Haema AG) and BPC Plasma, Inc., which were subsequently sold to Scranton in December 2018, for the same amount and conditions under which they were acquired.
The following indicators support the power that Grifols maintains over these companies, even after their sale to Scranton and that, therefore, it retains control over Haema and BPC in accordance with IFRS 10:
Therefore, although Scranton owns all of the voting rights, Grifols manages the businesses and acquires 100% of BPC and Haema’s production and in the event of any discrepancy between Scranton and Grifols, Grifols has the ability to exercise the right of the purchase option at any time.
As a result of all of the above, Grifols has the power to direct the relevant activities of these companies, since it manages them and jointly determines their business plan, having the unilateral right to repurchase 100% of both companies. The fact that Grifols has a currently exercisable purchase option implies that it acts as principal in the exercise of power (i) through the management contract and (ii) by not having delegated said power. Therefore, Grifols maintains control in both companies and therefore consolidates them.
In relation to the purchase option and given that it is based on a variable number of shares and a variable acquisition price, said instrument is a derivative financial instrument that must be valued at fair value with changes in the profit and loss account.
Based on the abovementioned contractual conditions, Grifols has estimated the value of the exercise of the repurchase option as follows: (i) the price at which the Selling Companies (Grifols Shares Services North America Inc (for the shares of BPC Plasma Inc) and Grifols Worldwide Operations Limited (for the shares of Haema GmbH)) sold the shares to Scranton (totalling USD 538 million), plus (ii) the change in working capital. Based on the business models of Haema and BPC, this change in working capital is expected to primarily reflect the undistributed profits at the time of exercise of the repurchase option. Given that the price of the exercise of the repurchase option aligns closely with the fair value of BPC and Haema, this option’s overall value is not considered significant. Furthermore, since the valuation of the option relies on unobservable market factors, it falls under Level 3 of the fair value hierarchy. Considering the uncertainties underlying the valuation of the option as it deals with non-observable variables, and the value of the same not being significant, said value has not been recognized as a 31 December 2025 and 2024 (note 29).
F-84
Previous to the sale of the 20% participation in Shanghai RAAS Blood Products Co Ltd (SRAAS hereinafter), there was an indirect participation:
Since IAS 28 does not address how to account for cross-participations, Grifols opted to: in the equity method of integration of the result of SRAAS, the result that SRAAS recognized when integrating the result of GDS by its percentage of participation (45% of GDS) was excluded. Therefore, Grifols’ consolidated result did not include 11.96% of GDS’s result recognized in SRAAS (equivalent to 45%*26.58%) to avoid duplications, since the GDS Group is consolidated by global integration.
When determining the allocation of the GDS result attributed to the non-controlling interest (SRAAS), SRAAS’s percentage of participation in GDS was adjusted by 11.96% and therefore, the percentage to attribute the result was 33.04% (45% - 11.96%) for the period ended as of 31 December 2023.
As a result of the sale transaction (Note 10), Grifols now owns 6.58% of the participation in SRAAS (financial investment), so it losses its significant influence over its interest in SRAAS and, consequently, its indirect 11.96% stake in GDS’ capital that it held. In the current year, the effective percentage of non-controlling interest recognized in GDS is 45%.
Grifols, S.A. has control over GDS through Grifols Shared Services North America, Inc (hereinafter GSSNA), following the entry of the new shareholder Shanghai RAAS Blood Products Co Ltd.
Grifols, S.A., through GSSNA, owns 60% of the Class A shares with voting rights and 50% of the Class B shares without voting rights, with both classes of shares having the same economic rights, so the economic rights amount to 55%. SRAAS owns 40% of class A shares and 50% of class B shares and economic rights of 45%.
Both shareholders have the right of first refusal in the event of a sale of the stake by each of the parties. In addition, SRAAS has certain veto rights, although Grifols has control over GDS for the following reasons:
F-85
(18)Provisions
Details of provisions at 31 December 2025 and 2024 are as follows:
Provisions for pensions and similar obligations
Note 26
Other provisions
Non-current provisions
Trade provisions
Current provisions
Total provisions
The movement in non-current and current provisions is as follows:
Net charges
Net cancellations
(39)
The amounts included under the non-current provisions heading mainly relate to provisions recognized by the Group in connection with retirement benefit obligations and other employment-related commitments for certain employees (see Note 26).
F-86
(19)Financial Liabilities
This note provides information on the contractual conditions of the Group’s financial liabilities, which are measured at amortized cost, except for the financial derivatives that are valued at fair value. For further information on exposure to interest rate risk, currency risk and liquidity risk and the fair values of financial liabilities, please refer to note 30.
Details at 31 December 2025 and 2024 are as follow:
Milllions of Euros
Non-current bonds
(a)
5,340
5,418
Senior secured debt
(b)
2,186
2,373
Other loans
Other non-current financial liabilities
(d)
732
853
Non-current financial derivatives
Non-current lease liabilities
Loan transaction costs
(232)
Total non-current financial liabilities
Current bonds
292
Other current financial liabilities
Current financial derivatives
Current lease liabilities
Total current financial liabilities
a)Senior Notes
Detail of Senior Notes at 31 December 2025 is as follows:
Issuance date
Company
Nominal value
Currency
Annual coupon
Maturity
Unsecured senior notes
5/10/2021
1,400
3.875
4.750
Secured senior notes
15/11/2019
770
2.250
30/4/2024
1,000
7.500
4/6/2024
19/12/2024
1,300
7.125
(1)Listed on the Euronext Global Exchange Market of the Irish Stock Exchange (ISE)
(2)As a result of the merger between Grifols Escrow Issuer, S.A. and Grifols, S.A. in the fiscal year 2023 (see note 2).
F-87
New Debt Issuances in 2024
On April 30, 2024, Grifols, S.A. closed the issuance of senior secured corporate notes (Senior Secured Notes) amounting to Euros 1,000 million. Subsequently, on June 4, 2024, an additional private placement of senior secured notes amounting to Euros 300 million was completed. Both placements mature in May 2030 and bear an annual coupon of 7.5%, having the same economic terms and benefiting from the same personal garantees and in rem security as the senior secured notes issued on November 15, 2019. These notes have customary change of control protection in respect of the issuer. The funds obtained were used to repay the senior unsecured notes (“Grifols Senior Unsecured Notes”) maturing in May 2025 amounting Euros 1,000 million and to partially repay (for an amount of Euros 300 million) the Group’s revolving credit facility of the Group’s Credit and Guaranty Agreement originally dated November 15, 2019 (the “Credit Agreement”) (note 19(b)).
Additionally, during 2025, the Group carried out certain actions related to this financing structure. Specifically, on November 12, 2025, with the support of nearly 95% of the bondholders, the proposed amendment to the indenture governing this bond issuance was approved. This amendment enabled the alignment of certain provisions of the 7.5% notes and their governing agreement with those applicable to the 7.125% senior secured notes due 2030, which were issued subsequently by the Group.
On December 19, 2024, Grifols, S.A. closed the issuance of senior secured corporate notes (Senior Secured Notes) amounting Euros 1,300 million, maturing in May 2030 and bearing an annual coupon of 7.125%. These notes also have customary change of control protection and in addition they have an special redemption feature during the call protection period (“non-call period”) allowing for a favorable redemption price versus the make-whole cost during such non-call period. The net funds obtained from such issuance were used, together with available cash, to: (i) fully repay the Senior Secured Notes (“Senior Secured Notes”) of Grifols, S.A. maturing in February 2025, for an amount of Euros 343 million; and (ii) fully clean-down the amount drawn under the revolving credit facility of the Credit Agreement (note 19(b)).
Details of movement in the Senior Notes at a 31 December 2025 are as follows:
Operating
outstanding
balance at
Exchange
01/01/2025
Issuance
Cancellation
Senior secured corporate notes 2019
740
Senior unsecured corporate notes Euros 2021
Senior unsecured corporate notes US Dollars 2021
679
(79)
600
Senior secured corporate notes 2024
2,600
Details of movement in the Senior Notes at 31 December 2024 are as follows:
01/01/2024
Senior unsecured corporate notes 2017
(1,000)
1,577
(838)
638
4,615
(1,838)
F-88
At 31 December 2025 and 2024 the current obligations caption includes the issue of bearer promissory notes to Group employees, as follows:
5/5/2025
4/5/2024
Maturity date
5/5/2026
4/5/2025
Nominal amount of promissory notes (Euros)
3,000
Interest rate
4.25
5.00
Promissory Notes subscribed
Buy-backs or redemptions
Interest pending accrual
b)Loans and borrowings
Details of loans and borrowings at 31 December 2025 and 2024 are as follows:
Amount
Carrying
Credit
Date awarded
extended
Senior debt - Tranche B
Euribor + 2.25%
15/11/2027
857
SOFR + 2.00%
2,344
1,334
1,516
Total senior debt
3,704
EIB Loan
2.02%
22/12/2017
22/12/2027
2.15%
25/9/2018
25/9/2028
Total EIB Loan
Revolving Credit
SOFR + 2.50%
15/11/2025
415
Revolving Credit Renewed
SOFR + 3.00%
30/5/2027
798
864
Total Revolving Credit
1,278
(59)
(88)
Non-current loans and borrowings
4,672
2,159
5,152
2,338
(*)
2.40%
20/11/2015
20/11/2025
Other current loans
0.10% - Euribor + 7.9%
277
261
Current loans and borrowings
316
(*) See amount granted under non-current debt.
Current loans and borrowings include accrued interest amounting to Euros 13 million at 31 December 2025 (Euros 26 million at 31 December 2024).
Between 2015 and 2018, the Group arranged three long-term loans with the European Investment Bank totaling Euros 270 million (divided into two loans of Euros 85 million and one loan of Euros 100 million, the latter maturing in the current financial year) to support its investments in R&D, mainly focused on the search for new therapeutic indications for plasma-derived protein therapies. The financial terms include a fixed interest rate, a maturity of 10 years with a grace period of 2 years. At 31 December 2025 the carrying amount of the loans obtained from the European Investment Bank amounts to Euros 53 million (Euros 85 million at 31 December 2024).
F-89
“Other current loans” included in 2024 a secured loan from the Group company Biotest, AG with an original term of 5 years until 2024. The total volume amounted to Euros 240 million, divided into two Term Facilities (B1 and B2) of Euros 225 million and a Revolving Credit Facility of Euros 15 million. As of December 31, 2025 and 2024, said loan was fully repaid in accordance with its maturity.
Additionally, it is relevant to mention that in 2024 the funds obtained from the sale transaction of Shanghai RAAS were used to amortize, on a pro-rata basis, the Senior Debt Tranche B maturing in 2027 and the Senior Secured Bonds (“Senior Secured Notes”) maturing in 2025. The prepayments were made towards next eight installments and the remainder was applied pro-rata against the remaining installments.
Senior Secured debt
The Senior Secured debt consists of an eight-year loan divided into two tranches: Tranche B in US Dollar and Tranche B in Euros. The terms and conditions of both tranches are as follows:
Details of Tranche B by maturity at 31 December 2025 are as follows:
US Tranche B
Tranche B in Euros
Principal in Millions
Principal in
Principal in Millions of
of US Dollars
1,567
1,575
1,341
The borrowers of the total Senior secured debt are Grifols, S.A. and Grifols Worldwide Operations USA, Inc.
Revolving credit facility
On 11 December 2024, and in relation to the Multicurrency Revolving Credit Facility (RCF), it was reported that the amount was increased from US Dollar 1,000 million to US Dollar 1,279 million until November 2025.
F-90
On 23 December 2024, and in relation to the Multicurrency Revolving Credit Facility (RCF), it was reported an 18- month extension of most of its current amount (the “RCF Extension”), with a new maturity in May 2027 and an amount of US Dollar 864 million. Following the extension of the Multicurrency Revolving Credit Facility (RCF), the financial expenses associated with the facility remain unchanged. Thereafter, on February 21, 2025 further commitments from banks were signed, increasing the RCF for an amount of US Dollar 74 million.
Following the extension of the Multicurrency Revolving Credit Facility (RCF), the finance costs associated with the facility remain consistent with the prior terms.
Movement in the Revolving Credit Facility is as follows:
Drawn opening balance
Drawdowns
1,276
1,340
Repayments
(1,277)
(1,723)
Drawn closing balance
c)Covenants
Restricted Covenants
The outstanding notes issuances and the Credit Agreement include customary restricted covenants, including the following:
Likewise, both the Grifols bond issuances and the Credit Agreement include a recurring financial obligation requiring certain subsidiaries of the Group to accede to the Credit Agreement and the bond issuances as personal guarantors, such that the EBITDA of the borrower/issuer, together with that of the guarantors, represents at least 60% of the Consolidated Adjusted EBITDA of the entire Group.
The guarantor entities are Grifols S.A., Grifols Worldwide Operations Limited, Grifols Biologicals LLC, Grifols Shared Services North America, Inc., Grifols Therapeutics LLC, Instituto Grifols S.A., Grifols Worldwide Operations USA, Inc., Grifols USA, LLC, Grifols International, S.A. and Grifols Biotest Holdings GmbH. In this regard, the Group periodically monitors compliance with this percentage and, as of year-end 2025 and 2024, it stood at 77% and 70.9%, respectively.
F-91
Additionally, the Credit Agreement includes as its sole recurring financial covenant the maximum leverage ratio (“Leverage Ratio”), calculated as the ratio between Consolidated Net Total Debt and Consolidated Adjusted EBITDA for the previous four quarters, in both cases calculated in accordance with the terms of the Credit Agreement. The value of this Leverage Ratio may not exceed 7.00:1.00, but compliance will only be required if, on the last day of the calendar quarter, the amount in U.S. dollars drawn under the Revolving Credit Facility of the Credit Agreement exceeds 40% of its maximum available amount. As of 31 December 2025 and 2024, given that there have been no drawings under the Revolving Credit Facility, the covenant compliance clause relating to the Leverage Ratio was not applicable.
As of December 31, 2025 and 2024, the Group is in compliance with the customary restricted covenants included in the financing agreements.
d)Other financial liabilities
Details of other financial liabilities at 31 December 2025 and 2024 are as follows:
Other financial liabilities
Non-current debt with GIC (sovereign wealth fund in Singapore)
(i)
665
Non-current preferential loans
(ii)
Transaction costs
Total other non-current financial liabilities
697
810
Current debt with GIC (sovereign wealth fund in Singapore)
Current preferential loans
Total other current financial liabilities
(i)Debt with GIC – Singapore sovereign wealth fund
In November 2021 approval was received from the pertinent authorities to close the agreement with GIC (Sovereign Fund of Singapore), announced in June 2021, whereby the Group received an amount of US Dollars 990 million in exchange for 10 ordinary Class B shares in Biomat USA and nine ordinary Class B shares in a new sub-holding, Biomat Newco, created for this purpose.
The main terms and conditions of the agreement with GIC were:
F-92
At 31 December 2025, current debt with GIC includes Euros 29 million of accrued interests plus Euros 44 million related to the share redemption right (Euros 34 million of accrued interests plus Euros 47 million related to the share redemption right at 31 December 2024).
Grifols did not have the discretional right to avoid payment in cash and therefore, the instrument is recorded as a financial liability.
The Group does not lose control of Biomat USA and continues overseeing all aspects of the Biomat Group’s administration and operations.
(ii)Other non-current and current financial liabilities
At 31 December 2025, “Other non-current financial liabilities” include mainly an unsecured long-term loan in the amount of Euros 46 million corresponding to Biotest, AG, a company acquired by the Group on 25 April 2022 (Note 3) (Euros 44 million at 31 December 2024).
At 31 December 2025, “other current financial liabilities” include mainly distributor commission liabilities of Euros 14 million corresponding to Biotest, AG (Euros 23 million at 31 December 2024). Additionally, this caption includes the acquisition price of the six Group 4 Centers arising from the Collaboration Agreement with Immunotek, the payment of which has been deferred until January 2, 2026, as well as the interest accrued through the end of fiscal year 2025 (Note 3).
Details of the maturity of other financial liabilities are as follows:
Maturity at:
Up to one year
Two years
Three years
Four years
Five years
Over five years
470
562
847
934
F-93
e)Changes in liabilities derived from financing activities
Senior Secured
debt & Other
Finance lease
Other financial
Bonds
loans
Carrying amount at 1 January 2023
4,692
4,042
1,017
1,006
10,757
New financing
1,506
1,624
Refunds
(122)
(1,172)
(1,468)
Interest accrued
352
655
Other movements
Interest paid/received
(148)
(308)
(73)
Note 3
Foreign exchange differences
(172)
4,682
4,324
1,111
939
11,056
2,616
3,949
(1,957)
(3,241)
(5,359)
228
399
746
(182)
(317)
294
5,429
2,656
1,141
941
10,167
New financing (*)
(1,427)
(1,669)
315
(279)
5,390
2,319
9,643
(*) Includes transaction costs
Details are as follows:
VAT payable
Taxation authorities, withholdings payable
Social security payable
F-94
The Group’s exposure to currency risk and liquidity risk associated with trade and other payables is described in note 30.
In accordance with the provision of Law 18/2022 that amends Law 15/2010 of 5 July, for fiscal years 2025 and 2024 information concerning the average payment period to suppliers is included.
Details at 31 December are as follows:
Salaries payable
Other current debts
Deferred income
Advances received
At 31 December 2025 and 2024, the advances received are contract liabilities relate to unperformed performance obligations for which Grifols has received a consideration from the customer.
(22)Net Revenues
Net revenues are mainly generated from the sale of goods.
The distribution of net consolidated revenues for 2025, 2024 and 2023 by segment is as follows:
Net sales
The geographical distribution of net consolidated revenues is as follows:
European Union
F-95
Details of discounts and other reductions in gross revenue are as follows:
Gross sales
10,603
9,490
8,389
Chargebacks
(2,524)
(1,892)
(1,525)
Cash discounts
Volume rebates
Medicare and Medicaid
(68)
Other discounts
(197)
Movement in discounts and other reductions in gross revenue during 2025 is as follows:
Medicare /
Medicaid
discounts
386
561
Current estimate related to sales made in current and previous periods (1)
2,524
3,078
(Actual returns or credits in current period related to sales made in current and previous periods) (2)
(2,391)
(178)
(2,881)
468
689
Movement in discounts and other reductions to gross revenue during 2024 was as follows:
1,892
2,277
(1,842)
(61)
(2,147)
F-96
Movement in discounts and other reductions to gross revenue during 2023 was as follows:
264
347
1,525
1,797
(1,460)
(81)
(1,721)
(23)Personnel Expenses
Details of personnel expenses by function are as follows:
1,444
1,373
1,384
Selling, general & administration expenses
531
497
2,170
2,051
2,086
Details by nature are as follows:
Wages and salaries
1,753
1,667
1,698
Contributions to pension plans
Other social charges
Social Security
335
308
On February 15, 2023, the Group announced the implementation of a comprehensive operational improvement plan with significant savings. The plan included the optimization of plasma costs and operations, the streamlining of corporate functions, and other initiatives to improve efficiency in the organization. It also included a reduction in staff in 2023 that affected approximately 8% of the human team, mainly in plasma operations in the United States. During the year 2025, the Group have recognized a severance expense of Euros 8 million (Euros 14 million during the year 2024 and Euros 75 million during the year 2023).
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a)Amortization and depreciation
Expenses for the amortization and depreciation of intangible assets, right of use assets and property, plant and equipment, incurred during 2025, 2024 and 2023 classified by functions are as follows:
273
275
447
b)Other operating income and expenses
Other operating income and expenses incurred during 2025, 2024 and 2023 by function are as follows:
737
211
610
712
799
1,558
1,524
Changes in trade provisions
Professional services
321
424
Commissions
Supplies and auxiliary materials
Operating leases
Freight
Repair and maintenance expenses
307
270
Royalties
Travel expenses
External services
R&D Expenses
Gains on disposal of assets
Other operating income&expenses
On February 15, 2023, the Group announced the implementation of a comprehensive operational improvement plan with significant savings. The plan included the optimization of plasma costs and operations, the streamlining of corporate functions, and other initiatives to improve efficiency in the organization. As of 31 December 2025, the Group recognized an expense of approximately Euros 4 million (Euros 22 million at 31 December 2024) mainly in professional services.
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Finance costs from Senior Unsecured Notes
(230)
(177)
Finance costs from senior debt
Note 19(b)
(280)
Finance costs from other financial liabilities
(64)
Capitalized interest
Other finance costs
During 2024, the heading Finance costs from Senior Unsecured Notes includes financial expenses arising from the interest corresponding to senior secured bonds with a principal amount of Euros 1.300 million issued at 7.5% that were used to amortize senior unsecured bonds with a principal amount of Euros 1.000 million and an interest of 3.2% per annum.
The finance costs from other financial liabilities heading for 2025 includes finance costs related to the interest on the funds received by GIC amounting Euros 64 million (Euros 69 million at 31 December 2024) (see note 19(d)).
During 2025, the Group has capitalized interest at a rate of between 6.11% and 6.54% based on the financing received (between 6.88% and 7.38% during 2024).
The Group offers certain employees pension plans and other long-term benefits. These plans include both defined contribution plans, under which the Group’s obligations are limited to making periodic contributions and do not impact the balance sheet, and defined benefit plans, which involve future commitments and are recognized on the balance sheet as employee benefit liabilities.
Obligations arising from defined benefit plans are calculated using actuarial methods and updated annually. Contributions to defined contribution plans are recorded as an expense in the period in which they accrue.
a) Defined Contribution Plans
For defined contribution plans, the Group is responsible for making a previously agreed contribution and does not assume any additional obligation or commitment beyond the agreed contribution.
The Group’s annual contribution to defined contribution pension plans of Spanish Group companies for 2025 has amounted to Euros 1 million (Euros 1 million for 2024).
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Additionally, the Group has a defined contribution plan (savings plan), which qualifies as a deferred salary arrangement under Section 401 (k) of the Internal Revenue Code (IRC). Once eligible, employees may elect to contribute a portion of their salaries to the savings plan, subject to certain limitations. The Group matches 100% of the first 4% of employee contributions and 50% of the next 2%. Group and employee contributions are fully vested when contributed. The total cost of matching contributions to the savings plan was US Dollars 36 million in 2025 (US Dollars 34 million in 2024).
The Group also has a defined benefit pension plan for certain former Talecris Biotherapeutics, GmbH employees in Germany as required by statutory law. The pension cost relating to this plan is not material for the periods presented.
b) Defined Benefit Plans
The Group has established retirement benefits and employment commitments for certain employees, primarily from its German companies. These benefits are based on employees’ length of service and salary. The pension plans are voluntary and are not subject to statutory or legal obligations. The amount of pension liabilities largely depends on fluctuations in interest rates and the life expectancy of the beneficiaries. The liabilities arising from these plans are presented under the provisions heading (see Note 18).
In financial year 2025, assets of Euros 11 million, were mainly held by a trustee, company of the group, under a contractual trust arrangement (CTA) as external insolvency insurance for portions of the occupational pension scheme (Euros 11 million at 31 December 2024). Since the transferred funds qualify as plan assets in accordance with IAS 19, provisions for pensions and similar obligations were netted with the transferred assets. As a result, provisions for pensions and similar obligations were reduced accordingly.
At 31 December 2025 and 2024, the net defined benefit liability of the Group comprises the following:
From pension plans
From similar obligations
Net present value of defined benefit obligations
For pension plans
For similar obligations
Fair value of plan assets
Net defined benefit liability
The costs for the defined benefit plans consist of the following components:
Current service cost
Net interest expenses
Total expenses recognised in profit and loss
Actuarial (gains)/losses due to experience adjustments
Actuarial (gains)/losses due to changes in financial assumptions
Revaluation recognised directly in other comprehensive income
Defined benefit costs
In financial year 2025, actuarial gains of Euros 6 million are recognized in other comprehensive income (actuarial gains of Euros 3 million at 31 December 2024). Of this amount, a gain of Euros 4 million resulted from changes in actuarial assumptions (Euros 1 million of gains at 31 December 2024.
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The following table shows the reconciliation of the net present value of the defined benefit obligation (DBO):
Net present value of defined benefit obligation
Interest expense
Expenses recognised in the statement of profit and loss
Actuarial losses due to experience adjustments
Actuarial gains due to changes in financial assumptions
Pension benefits paid
Net present value of defined benefit obligations at 31 December
The following payments are expected to be made in subsequent years based on the current pension obligations of the Group:
In the next 12 months
Between 2 and 5 years
Between 5 and 10 years
After 10 years
Total expected payments
The weighted average term of the defined benefit plans is 11.6 years as of 31 December 2025 (11.7 years at 31 December 2024).
Plan assets of the Group were invested in the following asset classes as of the reporting date:
Financial investment
Fund shares
The plan assets transferred are invested in accordance with defined investment principles, whereby the maturity or termination option of the financial instruments must always be selected in such a way that the association can meet its payment obligations. In accordance with the investment principles, the assets can be invested in Euro time deposits as well as domestic government bonds, mortgage bonds or fund units in money market funds or corporate bonds, all in Euro. Loans can also be issued to the Group companies against the corresponding guarantees. A minimum rating of A- is required for all financial instruments.
The calculation of the pension plans is based on the following actuarial assumptions:
Discount rate
3.9
Expected return on plan assets
3.4
Rate of increase for wages and salaries
Rate of interest for pensions
Employee turnover rate
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Actuarial assumptions are mainly based on historical empirical values with the exception of the discount rate. The calculation was based on the published Heubeck 2018 G mortality tables.
Under IAS 19.145, the effect of any possible changes to parameters for the underlying assumptions used to calculate the pension obligations must be disclosed in the sensitivity analysis. Only changes that are realistically expected to occur in the following financial year are to be considered.
The actuarial rate of interest, salary trend, pension trend and life expectancy are regarded as material assumptions. These parameters are shown in the following overview together with information on the parameter changes and their impact on the net present value calculation as of 31 December 2025.
Parameter change
Impact on the pension obligation
Rate of interest
Increase by 50 basis points
Decrease by 50 basis points
Pension trend
Increase by 100 basis points
Decrease by 100 basis points
Life expectancy
Increase by one year
The impact on the net present value calculation as of 31 December 2024 is as follows:
An amount of Euros 14 million (Euros 13 million at 31 December 2024) was recognized as an expense for defined contribution plans and is broken down as follows:
Employer contributions to statutory pension scheme
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In May 2023, the Board of Directors approved a proposal to the Ordinary General Meeting on 16 June, 2023, which approved it, a long term incentive plan. based on the granting of stock options for certain executive directors, members of the senior management of Grifols and its subsidiaries.
The plan has a term of four years for each beneficiary, from the effective date where 40% of the options granted will vest (provided that the conditions for their vesting are met) at the end of the second year of the plan and the remaining 60% will vest (provided that the conditions for their vesting are met) at the end of the fourth year of the plan. A maximum of 4 million stock options will be granted, representing the right to acquire 4 million Class A shares of the Company with an exercise price of Euros 8.96 per Class A share.
As a condition for the vesting of the options granted, each beneficiary must have remained continuously employed by Grifols on each vesting date, must pass an individual performance evaluation and, in addition, settlement is subject to the achievement of specific, predetermined and quantifiable objectives, related to financial and non-financial metrics, in order to reward value creation through the achievement of the objectives set in the plan. The Company will allocate the shares it currently holds in treasury or may come to hold to cover the needs of the plan.
Settlement date
Number of shares assigned
Unit fair value (Euros)
956,000
3.05
1,458,000
2.85
Additionally, there is a special remuneration plan referenced to the value of the share settled in equity instruments for certain executives with an exercise price of Euros 8.964 and Euros 12.84 per Class A share and maturity 2024 and 2025.
31/12/2026
700,000
1.08
270,000
2.19
On June 5, 2025, the Annual General Shareholders’ Meeting approved, as an extraordinary measure and with the aim of correcting an inconsistency for equity reasons, the adjustment of the exercise price of the options from Euros 12.84 to Euros 8.96 per Class A share.
The recognized amount in Equity as 31 December 2025 and 2024 amounts to Euros 6 million.
In May 2023, the Board of Directors of Grifols, S.A. approved a new long-term incentive plan based on restricted stock units (RSUs) aimed at certain members of the management team of the Company and its subsidiaries.
The plan has a total duration of four years, where 50% of the RSUs granted will be settled at the end of the second year of the plan and the remainder at the end of the fourth year of the plan. As a condition for the vesting of the RSUs granted, each beneficiary must have remained continuously employed by Grifols on the settlement date of the plan and, in addition, such settlement is subject to the achievement of performance objectives.
The RSUs will be settled in cash for an amount equivalent to the average price of the Class A shares during the five (5) business days prior to the settlement.
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In May 2025, 50% of the RSUs granted were settled, amounting to Euros 2 million. At 31 December 2025, the total accumulated amount is Euros 2 million as long-term in the heading “Provisions” (Euros 3 million at 31 December 2024, of which Euros 2 million were short-term in the heading “Trade creditors and other accounts payable” and Euros 1 million were long-term in the heading “Provisions”).
The amount recognized in the Consolidated Statement of Profit and Loss as of 31 December 2025 and 2024 amounts to Euros 1 million.
Number of RSUs assigned
258,550
9.42
In 2024, the Group has signed contracts with certain executives, establishing a long-term share-based or cash-based incentive as part of its remuneration system.
In the case of transfer of shares, these will be made in equal terms on the anniversary date or at the end of the period, according to the terms of the agreement.
Each beneficiary must have been continuously employed by Grifols until the settlement date. The amount recognized in equity as of 31 December 2025 amounts to Euros 4 million (Euros 1 million as of 31 December 2024).
Stock Incentive plan
On 5 June 2025, the Annual General Shareholders’ Meeting approved the 2025 Stock Incentive Plan - a long-term variable compensation plan - to be offered on a discretionary basis to members of the senior management team and other key employees of the Group.
The purpose of the plan is to align the interests of the beneficiaries with those of the shareholders and to support the long-term success of the company by promoting sustainable value creation, retaining key talent, and aligning with market standards.
The potential beneficiary group includes approximately 47 individuals, of whom 11 are senior executives. Neither the CEO nor the CFO will be beneficiaries of the Plan.
The plan has a three-year vesting period, which began on April 29, 2025, and will be settled in Class A shares within a reasonable period after the completion of such vesting period. Senior executives will receive 100% of their award in the form of performance shares, while the remaining participants will receive 65% in performance shares and 35% in fidelity shares.
The maximum number of shares to be delivered is 1,032,671, subject to the achievement of specific targets. For senior executives, 100% of the vesting of performance shares will depend on the relative Total Shareholders Return (TSR) compared to a predefined peer group. The plan includes performance thresholds and payout curves for deliveries ranging from 0% to 150% of the target, depending on the level of achievement of the performance criteria.
The amount recognized in equity as of 31 December 2025 amounts Euros 3 million.
Other obligations with personnel
In the event that control is taken of the Company, the Group has agreements with 29 employees/directors whereby they can unilaterally rescind their employment contracts with the Company and are entitled to termination benefits ranging from one to five years’ salary.
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In addition, the share-based remuneration plans maintained by the Company for certain employees include clauses according to which, in the event of a change of control, the amounts pending exchange would be early settled under the terms described in said agreements.
The Group has contracts with 21 executives entitling them to termination benefits ranging from one to four years of their salary in different circumstances.
(28)Taxation
In tax matters, and in particular with regard to income tax, the Group is subject to the tax regulations of various jurisdictions, as a result of the Group’s geographical dispersion and the highly international nature of the activities carried out by its companies. In this context, the effective tax rate is influenced by the distribution of the profit generated among the different countries in which the Group operates
a)Applicable taxes
Grifols, S.A. is authorized to file consolidated tax returns in Spain with Grifols Movaco, S.A., Laboratorios Grifols, S.A., Instituto Grifols, S.A., Biomat, S.A., Grifols Viajes, S.A., Grifols International, S.A., Grifols Engineering, S.A., Araclon Biotech, S.L. and Aigües Minerals de Vilajuiga, S.A. Grifols, S.A., in its capacity as Parent, is responsible for the filing and settlement of the consolidated tax return. Under prevailing tax law, Spanish companies pay 25% tax, which may be reduced by certain deductions.
The North American company Grifols Shared Services North America, Inc. is also authorized to file consolidated tax returns in the USA with Grifols Biologicals Inc., Grifols USA, LLC., Biomat USA, Inc. and Grifols Therapeutics Inc. The profits of the companies domiciled in the USA, determined in accordance with prevailing tax legislation, are subject to tax of approximately 22% of taxable income, which may be reduced by certain deductions.
During fiscal year 2025, the German tax legislation applicable to corporate income tax maintains its current rates in accordance with the tax rules enacted as of the reporting date. The statutory corporate income tax rate in Germany is 15% on the taxable base, to which a solidarity surcharge of 5.5% on the calculated tax is applied, resulting in a combined federal rate of approximately 15.825%. In addition, entities are subject to a municipal trade tax, the amount of which varies depending on the municipality in which the business activity is carried out, bringing the typical combined effective tax rate to a range of approximately 23% to 33%, depending on the relevant local jurisdiction.
Furthermore, in 2025 the German authorities approved a fiscal stimulus program aimed at encouraging business investment, which includes, among other measures, the gradual reduction of the corporate income tax rate starting in 2028—decreasing progressively from the current level until reaching a rate of 10% in 2032—subject to the enactment of the relevant legislation and approval by the German legislative chambers. These expected future changes may affect the measurement of deferred tax liabilities, in accordance with the applicable accounting criteria. The positive impact recorded under the caption ‘income tax expense’ amounted to Euros 51 million in fiscal year 2025.
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted into law in United States. The OBBBA includes various corporate tax provisions, such as the permanent extension or modification of certain expiring provisions originally enacted under the Tax Cuts and Jobs Act of 2017, changes to the international tax regime, and the restoration of favorable tax treatment for certain business provisions. The changes resulting from the OBBBA have multiple effective dates, with some provisions becoming effective in 2025 and others phased in through 2027. Key corporate tax provisions include the restoration of 100% bonus depreciation, optional immediate expensing for domestic research and experimental expenditures, modifications to the Section 163(j) interest limitations, and updates to the GILTI and FDII regimes.
The enactment of the OBBBA did not result in any material adjustments to total income tax provision of the Group for the year ended December 31, 2025. The Group has updated the deferred tax balances to reflect the impact of the OBBBA based on currently available information. As tax laws, related regulations, and interpretations continue to evolve, the current assessments may be revised in future periods as additional guidance regarding the application of the OBBBA becomes available.
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b)Reconciliation of accounting and taxable income
Details of the income tax expense and income tax related to profit for the year are as follows:
Profit before income tax from continuing operations
Tax at 25%
Permanent differences
Effect of different tax rates
Effect of the change in the tax rate in Germany
Tax credits (deductions)
Prior year income tax expense
Other income tax expenses/(income)
Total income tax expense
231
Deferred tax
Current tax
306
The effect of the different tax rates is basically due to a change of country mix in profits.
As of December 31, 2025, and 2024, the caption “Other income tax expenses/(income)” includes, among other concepts, the accrual of fiscal provisions (see Note 28(f)).
c)Amounts recognized directly in shareholders’ equity
The breakdown of the tax effect associated with each component of the ‘Other Comprehensive Income’ caption is as follows:
2024
Gross
Foreign currency translation differences
Gains and losses on non‑current assets held for sale
Gains and losses on the remeasurement of defined benefit plans
Gains and losses on the measurement of financial assets at fair value
(1,130)
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d)Deferred tax assets and liabilities
Details of deferred tax assets and liabilities are as follows
Tax loss carryforwards
Fixed assets, amortisation and depreciation
IFRS16 deferred assets
Other (a)
Subtotal, assets
462
IFRS16 deferred liabilities
(38)
Subtotal, net liabilities
(48)
Deferred assets, net
(449)
(451)
(573)
(679)
Fixed assets
(89)
(101)
Debt cancellation costs
Deferred tax liability under IFRS 16
(154)
Subtotal, liabilities
(1,283)
(1,416)
Deferred tax asset under IFRS 16
Subtotal, net assets
404
Net deferred Liabilities
(861)
(1,012)
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Movement in deferred tax assets and liabilities is as follows:
Deferred tax assets and liabilities
(670)
(688)
(860)
Movements during the year
Business combination (note 3)
(445)
The Spanish companies have opted to apply accelerated depreciation to certain additions to property, plant and equipment, which has resulted in the corresponding deferred tax liability.
The remaining assets and liabilities recognized in 2025, 2024 and 2023 were recognized in the statement of profit and loss.
The majority of the tax deductions pending application from Spanish companies related mainly to research and development, mature in 18 years. Likewise, the Group estimates that practically the entire amount will be applied in 5 years.
The Group has not recognized as deferred tax assets the tax effect of tax loss carryforwards of Group companies amounting to Euros 74 million (Euros 125 million as of 31 December 2024).
The amount of unrecognized deferred tax liabilities associated with investments in subsidiaries was Euros 75 million as of 31 December 2025 (Euros 80 million as of 31 December 2024).
Commitments arising from the reversal of deferred taxes relating to portfolio provisions are not significant.”
f)Years open to inspection
In accordance with the tax legislation applicable in each jurisdiction, the tax authorities may review and reassess the principal taxes of the Group’s consolidated entities for those fiscal years that remain within the respective statutory limitation periods. The length of such periods varies by country, with the most relevant for the Group being the following:
Ireland applies a four‑year statute of limitations, measured from the end of the chargeable period in which the relevant tax return is filed. Therefore, the tax periods still open are 2021 onwards.
In Germany, under normal circumstances, tax years may be subject to examination for up to four years from the end of the calendar year in which the tax liability arose. Fiscal year 2022 is the last year still open to inspection.
In Spain, a four‑year statute of limitations applies, beginning on the day following the end of the statutory filing deadline for submitting the tax return. However, since the parent company is currently involved in litigation regarding a tax assessment issued by the Spanish tax authorities for fiscal years 2017 to 2019, the statute of limitations for those years has been interrupted. Consequently, 2017 remains the last fiscal year still open to inspection.
For the United States (federal level), the statute of limitations is three years from the filing date of the tax return. This means that, as of December 31, 2025, fiscal years 2022, 2023, and 2024 remain open. In addition, fiscal years 2017 and 2018 also remain open as they are currently under examination.
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Tax Audits
The Group is currently undergoing the tax audits explained below. Note that the Group acts with the tax authorities in a cooperative and transparent manner to resolve disputes and considers that its position in the years and matters described below is in accordance with the law and is based on a reasonable interpretation of the applicable regulations. Therefore, the Group intends to file all the appropriate appeals and petitions to best defend its interests. Procedures related to taxes currently on-going are detailed below.
On 8 November 2021, the Group agreed to the resulting assessments (“conformidad”). No penalties were imposed on any of the Group companies for any of the taxes subject to audit.
This audit has resulted in an adjustment impacting the allocation of taxable income between different jurisdictions and in light of their effect on the Group’s transfer pricing position. Therefore, the Group now has a legal right to recover certain amounts from the corresponding jurisdictions, under a Mutual Agreement Procedure (MAP) in accordance with the provisions of the European Convention on the elimination of double taxation in connection with the adjustment of profits of associated companies. This MAP is currently on-going and, as of 31 December 2025, the Group has recognized a current tax asset of 18 million euro in relation to this matter.
The focus of the audit by the US Internal Revenue Service (“IRS”) is an intercompany intangible licensing transaction and the income generated in the United States from this transaction. The IRS is finalizing a proposed adjustment related to this issue. The Group believes that its transfer pricing position with respect to this intercompany transaction reflected in the originally filed tax returns is robust and that it has meritorious defenses to any IRS proposed adjustment.
In accordance with U.S. tax law, any future tax assessment issued by the IRS (which would include interest running from the filing due date of the original returns) would not give rise to a payment obligation until the taxpayer has exhausted the administrative alternatives that are available to challenge an IRS proposed adjustment (including competent authority proceedings and certain judicial proceedings).
In general, the Group strives to resolve open matters with each tax authority at examination level and may either reach an agreement with a tax authority at any time in the process or later decide to challenge any assessments raised. In any case, the Group reserves its right to file all relevant appeals and claims (both domestic and international) necessary to defend its interests. It is unlikely for the resolution of this complex tax matter to take place within the next 12 months.
In July 2024, the Group disagreed to the corresponding assessment proposals (“disconformidad”) and has received the corresponding final assessments. No penalties were imposed on any of the Group companies for any of the taxes subject to these audit proceedings.
As regards Corporate Income Tax, the assessment is based on a different pricing criteria approach, interrelated with the items under review by the IRS and affecting different jurisdictions in which the Group operates.
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In relation to VAT, the assessment relies on a different interpretation of the financial activity carried out by the Group and how such difference affects the deductibility of certain expenses. In this last case, the Group’s position has been partially upheld in a ruling by the Spanish Central Administrative Tribunal (“Tribunal Económico-Administrativo Central”). As noted, the Group intends to file all the appropriate appeals and petitions to best defend its interests.
Moreover, in June 2025, the Spanish State Tax Administration Agency initiated audit proceedings as regards certain Group companies domiciled in Spain, taxed under the Spanish tax consolidation regime. The audit relates to Corporate Income Tax for the fiscal years 2020 to 2023 and Value Added Tax, personal income tax, non-resident income and capital income tax for 2021 to 2023. The audit is currently in its initial stages.
The net tax provision included in the group’s Financial Statements to cover the worldwide exposure to uncertain tax treatments at December 31, 2025 is Euros 180 million, taking into account the offset carried out by the Spanish Tax Authorities for an accumulated amount of 47 million (Euros 137 million as of December 31, 2024). This provision is included under the caption “other creditors” (“Other public entities”) in the consolidated balance sheet. This increase in the net tax provision for uncertain tax positions relates to transfer pricing mainly as a result of an update of potential tax liabilities following the tax audits mentioned above.
Transfer pricing matters are complex, highly subjective and open to disputes involving different tax jurisdictions. The topics under discussion are complex and may take many years to resolve. The tax liability includes uncertain tax treatments that are estimated using either the most likely amount method or the expected value method and depend on the Group’s assessment as to whether the approach taken by the Tax Authorities is likely to be sustained by Tribunals or Courts. Such assessment could change in the future to reflect progress in Tax Authorities’ reviews to the extent that any Tax Authority review is concluded; progress in on-going appeals and international procedures, including the return of taxes which have already been paid under the assessments set out above; changes in legal provisions or in the interpretation of such provisions; or even expiry of the corresponding statutory periods of limitations.
Management believes that it is unlikely that additional liabilities, above the amounts provided, will arise. Also, it is possible that the amounts provided may change and be partially, or even entirely, mitigated in future periods, as reviews, appeals or procedures challenging the Tax Authorities’ approach progress or even the relevant statutes of limitation expire. Management continues to believe that the Group’s position on all its transfer pricing, audits and disputes is robust, and that the Group has recognised appropriate tax provision balances, including consideration of whether corresponding relief will be available under applicable Mutual Agreement Procedures with the different countries.
Timing of cash flows
As highlighted above, the Group is currently under tax audit in several countries and the timing of any resolution of these audits is uncertain.
It is anticipated that tax payments may be required in relation to ongoing tax audits in the coming years in the various jurisdictions in which the Group operates and that, despite the fact that the issues in these audits are interrelated, these may occur in consolidated cash flows as they may affect different time periods. The Group, nevertheless, considers the tax liabilities set out above to appropriately reflect, according to current information, the expected value of any final settlement.
Some of the items discussed above are not currently within the scope of tax authority audits and may take longer to be resolved.
Minimum taxation (Pillar 2 OECD)
The Inclusive Framework on Base Erosion and Profit Shifting (BEPS) of the Organisation for Economic Co-operation and Development (OECD)/G20 addresses the tax challenges arising from the digitalisation of the global economy. The Global Model Rules against Base Erosion (Pillar 2 rules) apply to multinational enterprises (MNEs) with annual revenues exceeding €750 million according to their consolidated financial statements.
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On 23 May 2023, the International Accounting Standards Board issued the Model Rules for Pillar Two of the International Tax Reform – Amendments to IAS 12 (the Amendments). The Amendments clarify that IAS 12 applies to income taxes arising from tax legislation enacted or substantially enacted to implement the Pillar 2 model rules published by the OECD, including tax legislation that implements a mechanism (QDMTT) to allow the top-up tax to be collected in the jurisdiction of the subsidiary rather than the jurisdiction of the ultimate parent of the group. The Group has adopted these amendments, which introduce:
Pillar 2 rules have been adopted in numerous jurisdictions in which the group operates, including, significantly, in European Union jurisdictions such as Spain. In accordance with these rules, the Group is considered a multinational enterprise to which Pillar 2 rules will apply.
The Group has assessed its potential exposure to Pillar 2 income taxes based on the 2024 country-by-country reports and 2025 financial information of the Group’s constituent entities. The effective Pillar 2 tax rates in most jurisdictions in which the Group operates are higher than 15%. The most significant exceptions to this are:
The Group continues to monitor legislative developments in Pillar 2, as other countries enact the Pillar 2 model rules, to assess the potential future impact on its consolidated operating results, financial position and cash flows going forward.
(29)Other Commitments with Third Parties and Other Contingent Liabilities
a)Guarantees
Grifols is required to provide certain guarantees in the ordinary course of its business activities, as well as securities related to bids and contractual commitments. It is not expected that any additional liability will arise from these guarantees and sureties in the accompanying consolidated financial statements.
b)Guarantees committed with third parties
Grifols, through Grifols Shared Services North America, Inc, acts as a guarantor for two lease contracts for certain ImmunoTek plasma centers not affected by the collaboration under Biotek America LLC. In addition, and as a result of the acquisition of the Group 4 Centers, these are encumbered as collateral of the Promissory Note and (following the same guarantee provided by Grifols S.A. under the Collaboration Agreement with Immunotek) the Promissory Note is guaranteed by Grifols, S.A. (see note 3).
The Company maintains contractual commitments derived from its activity, which may involve the provision of guarantees and/or collaterals to third parties. Such guarantees are granted in accordance with the applicable contractual terms and include, among others, sureties, deposits or similar instruments.
Additionally, the Group has significant guarantees extended to third parties described in notes 17 and 19.
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c)Purchase commitments
Purchase and Sale Option for Grifols Canada Plasma, Inc. and Other Commitments
After the acquisition, the company previously known as CPR has been renamed Grifols Canada Plasma, Inc. (Note 10).
The Group has formalized a call/put option agreement over the remaining 49.90% of the share capital, exercisable from July 2026 and, in any case, before January 2027. The price will be determined according to a contractual formula based on twice the liters of plasma collected in the six months prior to (i) the month immediately preceding the closing, or (ii) the date on which the collection centers from, which Grifols obtains plasma in Canada, have reached 600,000 liters collected, whichever occurs first., multiplied by a price (320 or 250 Canadian Dollars per liter depending on the characteristics of the plasma center), together with adjustments for working capital and net debt. As of 31 December 2025, the value of the option is not significant.
In accordance with the acquisition agreement, the Group has granted a loan linked to the transaction, the amount drawn under which will reduce the future payment corresponding to the acquisition of the remaining interest. The loan, initially Canadian Dollars 2 million, may increase up to a maximum of Canadian Dollars 15 million depending on the volume of plasma collected by Grifols Canada Plasma, Inc.
The agreement includes a Subsequent Option (Fallback) mechanism, which allows, if the initial options are not exercised, a restructuring through the transfer of the Group’s interest in exchange for three operating centers, ensuring continuity of supply.
Additionally, the Group maintains a plasma purchase commitment from Grifols Canada Plasma, Inc.’s centers subject to contractual extension, and unit prices defined in the agreement.
The agreement also includes specific warranties and indemnities provided by the non-controlling shareholders, covering tax contingencies, ongoing litigation, and intellectual property claims, as well as liability caps equivalent to the purchase price.
Purchase option on BPC Plasma Inc. and Haema GmbH
Pursuant to the share purchase agreement dated 28 December 2018, the Group, through Grifols Shares Services North America Inc (for the shares of BPC Plasma Inc, formerly known as Biotest US Corporation (“BPC”) and Grifols Worldwide Operations Limited (for the shares of Haema AG, now called Haema GmbH (“Haema”)) (the “Selling Companies”) sold 100% of the capital shares of BPC and Haema to Scranton Plasma B.V. (“Scranton”). The share purchase agreement includes an option for the Selling Companies to repurchase the shares, granting the Selling Companies an irrevocable and exclusive right (though not an obligation) to repurchase the shares sold to Scranton at any time following the sale, provided that when the option of the repurchase of the shares of a company (BPC or Haema, as the case may be) is exercise, the option for the repurchase of the other company (Haema or BPC, as the case may be) is also exercised simultaneously.
The purchase option involves a fluctuating number of shares and a variable acquisition price. This characteristic classifies it as a derivative financial instrument that needs to be fairly valued, ultimately impacting the profit and loss account.
The exercise price for the option will be determined based on the higher of the following two amounts: (i) the aggregate of the price at which the shares were sold to Scranton, increased by any expenses relating to the completion of the transactions contemplated in the relevant share purchase agreement, plus the increase in net working capital from the date of sale until the repurchase completion date resulting from the exercise of the repurchase option; and (ii) the amount required to pay in full the indebtedness that Scranton incurred with the lending entity to purchase the shares of Haema and BPC from the Selling Companies, for an amount of Euros 425 million along with any accrued interest and additional amounts required to fully repay that indebtedness.
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Based on the abovementioned contractual conditions, Grifols has estimated the value of the exercise of the repurchase option as follows: (i) the price at which the Selling Companies sold the shares to Scranton (totalling USD 538 million) increased by any expenses relating to the completion of the transactions contemplated in the relevant share purchase agreement, plus (ii) the change in working capital. Based on the business models of Haema and BPC, this change in working capital is expected to primarily reflect the undistributed profits at the time of exercise of the repurchase option. Given that the price of the exercise of the repurchase option aligns closely with the fair value of BPC and Haema, this option’s overall value is not considered significant. Furthermore, since the valuation of the option relies on unobservable market factors, it falls under Level 3 of the fair value hierarchy.
In July 2024, Scranton entered into a loan agreement with funds controlled or managed by Oaktree (the “Loan Agreement”) to refinance the loan that Scranton had initially obtained from banks in 2019. According to the terms of the Loan Agreement, this financing benefits from the following guarantees and security interest: (i) by a guarantee from BPC, (ii) a pledge of the shares of Haema and BPC, and (iii) pledges over the assets of BPC. In March 2025 and once the transformation of Haema into a limited liability company in the form of GmbH had concluded, following the terms of the Loan Agreement, Haema acceded to the Loan Agreement as a guarantor and granted security over its assets as collateral for the Loan Agreement.
In the event of a default under the Loan Agreement, the Selling Companies can, respectively and simultaneously, exercise the repurchase option for both companies within 90 days after receiving notification of the default. If the Selling Companies fail to exercise this option within that timeframe, they will lose their right to repurchase the shares of Haema and BPC. As of 31 December 2025, no defaults have been reported under the Loan Agreement.
In relation to the sale of the shares of BPC Plasma, Inc. and Haema, GmbH, a loan was signed by Scranton Enterprises BV. with the Group on 28 December 2018 for an initial amount of US Dollars 95 million (Euros (87 million) which maturity has been extended to 28 June 2027 (previously December 2025). The remuneration is 2%+ EURIBOR and matures on 28 June 2027 (previously December 2025). In 2023 an additional amount of Euros 15 million was arranged under the same conditions as the initial loan. As of 31 December 2025, the recorded amount stands at Euros 124 million, including accrued and capitalized interest to date (Euros 132 million as of 31 December 2024) (see note 11).
Purchase option from Plasmavita Healthcare GmbH
On November 22, 2017, the company Plasmavita Healthcare GmbH was incorporated in Germany. Currently, the Group is a shareholder of 50% of the shares and two individual partners, shareholders of the remaining 50% of the Company’s shares. Through a management services agreement, one of them (the “Managing Partner”) provides certain management services to the Company. The Company’s incorporation agreement establishes a purchase option in favor of the Group that grants the irrevocable right (not the obligation) to the Group to acquire the remaining 50% stake in the Company from the two individual partners within a period of 6 months from the moment the Managing Partner ceases to provide the Company’s management services. The fair value of the purchase option is not material.
Purchase option with National Service Projects Organization (Egypt)
On July 29, 2021, Grifols entered into an agreement with the Egyptian entity National Service Projects Organization (“NSPO”), under which Grifols and NSPO established a company in Egypt for the construction and operation of 20 plasma collection centers in Egypt, a fractionation plant, and a protein purification and filling facility. Grifols and NSPO hold 49% and 51%, respectively, in this company. The agreement includes a call option and a put option for both shareholders, allowing each party to acquire from or sell to the counterparty the entirety of its ownership interest. These options may be exercised once a 10-year period has elapsed since the company’s incorporation. As the options are based on a variable number of shares and a variable amount, a derivative financial instrument exists, which must be measured at fair value through profit or loss. The exercise price of the option is based on a market value, which implies that, upon exercise, the price will approximate the fair value of the interest to be acquired. As of 31 December 2025, the value of the option is not significant.
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Canadian Blood Services
In September 2022, Grifols signed a collaboration agreement with Canadian Blood Services (CBS) to supply them with 2.4 million grains of Immunoglobulin exclusively through a network of Canadian plasma centers that should be fully developed and operational by 2027. To achieve this goal, Grifols will need to collect 600.000 liters of Canadian plasma annually from Grifols-owned plasma centers in Canada. For this reason, Grifols has made the following commitments for the acquisition of plasma and self-built centers in Canada:
d)Contractual commitments
Agreement on the sale of the 20% shareholding in SRAAS
As a consequence of the agreement to sell the 20% shareholding in Shanghai RAAS to Haier, both companies signed the following agreements:
Scenario
Percentage (1)
Baseline scenario
3.8
Sensitivity to Sales BTS
Sensitivity to Sales CDx
Sensitivity to Sales MDS
0.6
Worst scenario
(0.2)
Weighted scenario (baseline and worst)
1.8
Weighted scenario (all sensitivities)
1 - Variation (expressed in percentage) between the commited EBITDA of 850 million and the estimated EBITDA
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Commercial commitments
As of December 31, 2025, the Group maintains existing commercial commitments with customers amounting to Euros 31 million (USD 36 million), whose disbursements are expected to be realized in the following fiscal years:
2028-2031
e)Judicial procedures, arbitration and others
Details of legal proceedings in which the Group companies are involved are as follows:
On September 25, 2024, Grifols received notification that the Executive Committee of CNMV had initiated an administrative sanctioning procedure in connection with the conclusions reached by the CNMV on March 21, 2024. These conclusions were disclosed by the Company as Inside Information on the same date and subsequently supplemented. The proposed sanction against Grifols for the incidents mentioned in the conclusions and supplementary information does not exceed one Million Euros. On 7 November, 2024, Grifols submitted allegations against the initiation of the administrative sanctioning procedure. On 16 May, 2025 Grifols requested the CNMV to conclude the administrative procedure, which concluded with the resolution of the CNMV on 25 June, 2025, initiating a two-month period to commence the contentious-administrative procedure before the National High Court.
The appeal was formally filed before the National Court on September 24, 2025 and was admitted for processing by decree dated October 7, 2025. However, as of February 25, 2026, the National Court has not yet received the administrative file from the CNMV, and therefore Grifols has not been summoned to file the statement of claim.
The proceedings started with the squeeze out application on March 28, 2022 submitted with the Frankfurt District Court. On October 27, 2022, the Frankfurt District Court announced its decision that all ordinary shares in Biotest AG not yet directly or indirectly owned by Grifols S.A. must be transferred. A total of four defendants filed an appeal against this decision and on May 27, 2024 the Frankfurt Court of Appeals has rendered its decision to reject the defendants’ appeal at their costs. Subsequently the defendants’ objected to the cost decision and filed a legal complaint with the Federal Court of Justice. Grifols is waiting for the Federal Court of Justice to decide (Bundesgerichtshof, BGH).
On February 10, 2026, the BGH issued its final decision. The Court rejected the minority shareholders’ final appeal in its entirety, fully confirming the squeeze-out of all remaining ordinary Biotest shares in favour of Grifols at a cash compensation of EUR 43.00 per share. This decision is final and binding. As a result, Grifols holds directly or indirectly 100% of the ordinary shares of Biotest AG.
The Group is involved in specific legal procedures arising from its ordinary course of its activities in the United States, including individual claims for litigations derived from accidents occurring in certain facilities and certain wage and hour proceedings. These cases are in the very early stages and it is not yet known what the probability is that any of the cases can result in any potential relevant cash outflow for the Group. Based on past litigation and results, Grifols asserts that it is possible that one or more cases can reach to a material level in the future. In any case, Grifols will vigorously defend itself, and as part of its internal process, it will continue to asses, on a timely basis, any changes in facts and circumstances that may modify its risk evaluation. In the event that any of these contingencies becomes more probable, it will determine whether they could result in a material cash outflow.
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Management considers that the resolution or continuation of these proceedings and investigations will not have a material effect on the Group’s financial position, operating results or cash flows.
(30)Financial Instruments
a)Classification
Below is a breakdown of the financial instruments by nature, category and fair value. The Group does not provide details of the fair value of certain financial instruments as their carrying amount is very similar to their fair value because of its short term.
Fair Value
Financial
instruments at
financial
FVTPL
FV through OCI
Hedges
Amortised cost
Level 1
Level 2
Level 3
Non-current financial assets
337
Derivative instruments
431
Financial assets measured at fair value
768
Financial assets measured at amortized cost
1,355
Derivatives instruments
Financial liabilities measured at fair value
Senior Unsecured & Secured Notes
(5,314)
(5,455)
Promissory Notes
(2,139)
(2,203)
Other bank loans
(180)
(1,082)
(847)
(1,093)
(314)
Financial liabilities measured at amortized cost
(10,731)
(11,045)
(9,376)
(8,925)
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instruments at FV
through OCI
417
532
949
961
1,536
(5,356)
(5,231)
(2,310)
(2,360)
(346)
(1,142)
(934)
(1,062)
(318)
(11,223)
(11,541)
(9,687)
(9,050)
b)Measurement of fair value
In order to determine the fair value of financial assets or liabilities, the Group uses the following hierarchy based on the relevance of the variables used:
c)Financial risk management
This section provides information on the Group’s exposure to risks related to the use of financial instruments, the objectives and procedures for measuring and managing risk, as well as the capital management carried out by the Group. Grifols’ risk control and management system is designed to identify, assess, and manage risks that may affect the achievement of strategic objectives, providing reasonable assurance of their fulfillment.
The Group is exposed to the following risks
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The Group’s risk management policies are established with the aim of identifying and analyzing risks, setting appropriate limits and controls, and ensuring compliance with those limits. These policies are reviewed regularly to reflect changes in market conditions and in the Group’s activities and are integrated into planning and decision-making processes. The system is based on principles such as defining a risk tolerance framework, segregation of duties between operational and supervisory areas, and continuous improvement. It also seeks to foster a strict and constructive control environment in which all employees understand their roles and responsibilities.
Governance of the system lies with the Board of Directors, which approves the risk control and management policy. The Audit Committee oversees its effectiveness and periodically reviews its adequacy, assisted by Internal Audit through regular and ad hoc reviews. Likewise, the Risk Management Committee ensures the proper integration of risk management throughout the organization
(1)Credit risk
Credit risk is the risk of loss arising from the failure of customers or counterparties to meet their contractual obligations, and it mainly originates from trade receivables, financial investments, and cash and cash equivalent positions held with financial institutions.
For Grifols, exposure is concentrated in outstanding receivables, particularly from public entities, where payment delays are more common. This risk is mitigated by claiming interest in accordance with the applicable legislation, to which the Group is primarily entitled under Spanish regulations. In markets where transactions are carried out with private entities, no significant cases of insolvency or default have been identified.
Managing this risk is a priority for the Group, which applies a corporate policy aimed at maintaining exposure at acceptable levels. This policy combines the assessment and periodic review of credit risk with the definition of collection terms adapted to each market, the assignment of credit limits, and risk categorization, as well as preventive measures such as guarantees, advance payments, and credit insurance.
Additionally, the Group regularly monitors its exposure to credit risk with banks and financial institutions, maintaining a low-risk profile by working exclusively with highly solvent entities with strong credit ratings according to international agencies. The solvency of these entities is reviewed periodically to ensure active management of counterparty risk.
Exposure to credit risk
The carrying amount of financial assets represents the maximum exposure to credit risk. At 31 December 2025 and 2024 maximum level of exposure to credit risk is as follows:
Contractual assets
2,127
2,472
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The carrying amount of receivables and contractual assets by geographical area, at 31 December 2025 and 2024 is as follows:
EU countries
United States of America
Other European countries
Other regions
392
The Group is not exposed to significant credit risk, as both its cash positions and its derivative contracts are maintained with highly solvent financial institutions.
(2)Liquidity risk
Liquidity risk is defined as the risk that the Group may encounter difficulties in meeting its financial obligations as they fall due, particularly those requiring the delivery of cash or another financial asset. The Group’s approach to managing liquidity risk is to maintain, wherever possible, sufficient liquidity to meet its obligations at maturity under both normal market conditions and periods of financial stress, thereby avoiding unacceptable losses or reputational damage.
The Group manages liquidity riskprudently, based on availability of cash and sufficient committed and undrawn long-term credit facilities, and forecasted operating cash flows. These resources enable the Group to implement its business plans and operate with stable and reliable sources of funding.
Liquidity at the end of the period stood at Euros 1.678 million (including undrawn committed credit lines), with the following details:
Total cash and cash equivalents
Undrawn committed credit lines
1,279
Total Liquidity
1,678
2,259
The Credit Agreement establishes a limitation on the disposition of the “revolving line” that has not been exceeded as of 31 December 2025 and 2024.
The Group currently has adequate liquidity to meet its obligations through a combination of internally generated cash flows, existing cash reserves, and access to unused credit lines. Furthermore, the Group does not generate material cash flows in jurisdictions subject to significant restrictions on the repatriation of funds.
As in prior years, the Group continues to implement working capital optimization programs, primarily based on non-recourse receivables factoring arrangements, which contribute to efficient liquidity management.
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The main contractual obligations existing at the end of the fiscal year comprise mainly long-term financial debt obligations with capital repayments and interest payments (see note 19).
Details of the contractual maturity dates of financial liabilities including committed interest calculated using interest rate forward curves are as follows:
amount at
6 months or
6 - 12
More than
Contractual flows
less
months
1-2 years
2 - 5 years
5 years
Bank loans
2,598
2,309
650
Bonds and other marketable securities
6,602
1,029
5,158
Payable to suppliers
839
Financial derivatives
Note 30(d)
10,541
13,092
301
3,548
5,783
1,846
6 months
or less
3,162
362
2,514
1,489
414
766
6,959
293
3,673
848
11,061
14,284
1,731
344
702
6,920
4,587
(3)Currency risk
The Group operates across multiple jurisdictions and is therefore exposed to currency risk arising from commercial transactions denominated in foreign currencies, assets and liabilities and net investments in foreign operations. The Group’s principal exposure relates to the US Dollar.
The Group holds significant investments in foreign operations, the net assets of which are exposed to currency risk. To mitigate this risk, the Group has historically maintained borrowings in the same currency. This natural hedge reduces the impact of exchange rate fluctuations on consolidated equity.
The Group actively manages all balance sheet foreign exchange exposures and evaluates hedging strategies to manage volatility in financial results and equity.
The financing obtained in Euros represents 68% of the total debt of the Group and amounts to Euros 5,809 million at 31 December 2025 (66% and Euros 5,924 million at 31 December 2024). In this breakdown, ‘Group debt’ refers only to the nominal amount of the debt.
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Until September 13, 2024, when the currency swap was canceled, part of the US Dollar debt of the Group was covered by a currency swap to hedge the exposure to the associated currency risk.
The Group applied the cost of hedging method. This method enabled the Group to exclude the currency basis spread from the designated hedging instrument and, subject to certain requirements, changes in their fair value attributable to this component were recognized in other comprehensive income.
Details of the Group’s exposure to currency risk is as follows:
Euros (*)
US Dollars (**)
Receivables from Group companies
Loans to Group companies
5,605
604
Trade payables
Payables to Group companies
(52)
Loans from Group companies
(5,301)
Balance sheet exposure
584
Balances in Euros in subsidiaries with US Dollars functional currency
(**)
Balances in US Dollars in subsidiaries with Euros functional currency
4,644
453
(5,428)
(316)
(*)Balances in Euros in subsidiaries with US Dollar functional currency
(**)Balances in US Dollar in subsidiaries with Euros functional currency
The most significant exchange rates applied at 2025 and 2024 year ends are as follows:
Closing exchange rate
1.175
1.039
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A sensitivity analysis for foreign exchange fluctuations is as follows:
Had the US Dollar strengthened by 10% against the Euro at 31 December 2025 equity would have increased by Euros 723 million (Euros 1,068 million at 31 December 2024) and profit due to foreign exchange differences would have increased by Euros 97 million (decreased by Euros 27 million at 31 December 2024). This analysis assumes that all other variables are held constant, especially that interest rates remain constant.
A 10% weakening of the US Dollar against the Euro at 31 December 2025 and 31 December 2024 would have had the opposite effect for the amounts shown above, all other variables being held constant.
(4)Interest rate risk
The Group is exposed to interest rate risk primarily through its current and non-current borrowings. Variable-rate borrowings are subject to cash flow interest rate risk, as future interest payments may fluctuate with market rates. Fixed-rate borrowings are exposed to fair value interest rate risk, as changes in market rates affect the economic value of the debt.
The Group’s objective in managing interest rate risk is to maintain a balanced debt structure, combining fixed and variable rate instruments. This is achieved by issuing different portions of external financing at fixed or variable rates, depending on the market moment.
Additionally we can use derivative instruments to hedge part of the variable-rate exposure.
As of 31 December 2025 fixed-rate debt accounted for 73% of total borrowings (71% at 31 December 2024). This includes corporate senior notes, loans from the European Investment Bank, and the financing agreement with GIC (Sovereign Fund of Singapore). Variable-rate debt represented the remaining 27% (29% at 31 December 2024), primarily comprising senior secured debt (see note 19). This composition reflects the Group’s strategy to mitigate volatility in interest payments while preserving flexibility in its financing structure.
To date, the profile of interest on interest-bearing financial instruments is as follows:
Fixed-interest financial instruments
6,250
6,430
Variable-interest financial instruments
2,541
Total financial liabilities
8,527
8,971
Had the interest rate been 100 basis points higher at 31 December 2025 the interest expense would have increased by Euros 22 million (Euros 30 million at 31 December 2024). As the Group does not have any hedging derivatives in place, the net effect on cash interest payments would have increased by the same amount.
In this breakdown, “financial liabilities” and “total debt” refer solely to the nominal amount of the debt.
(5) Market price risk
Price risk affecting raw materials is mitigated by the vertical integration of the hemoderivatives business in a highly concentrated sector.
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d)Financial derivatives
At 31 December 2025 and 2024 the Group has recognized the following derivatives:
(*) Notional at
Value at
Foreign exchange rate forward
Swiss Franc
20/1/2026
Canadian dollar
Euro
11/2/2025
Pound Sterling
18/2/2025
Japanese Yen
1,700
1,200
Australian dollar
28/1/2025
Brazilian real
Energy PPA
Euro / KwH
31/12/2032
Total derivative assets
20/11/2026
Chilean Peso
4,000
Czech crown
Mexican Peso
9/1/2025
US dollar
26/2/2025
Total derivative liabilities
(*)Amounts of the national are stated in the derivative currency.
(1)Hedging derivative financial instruments
On 5 October 2021, the Group subscribed three cross currency interest-rate swaps with a notional amount of US Dollars 500 million to hedge part of the Euro equivalent value of the US Dollar unsecured notes issued in October 2021. It was a fixed-to-fixed USD/EUR cross currency swap with the following characteristics:
On 28 June 2022, the Group subscribed one cross currency interest-rate swap with a notional amount of US Dollars 205 million to hedge the remaining part of the Euro equivalent value of the US Dollar unsecured notes issued in October 2021. It was a fixed-to-fixed USD/EUR cross currency swap with the following characteristics:
F-123
On September 13, 2024, the cross-currency swap were terminated early. As of December 31, 2024, the Group recognized a net financial income of Euros 4 million under the heading ‘Fair Value Change in Financial Instruments’ in the Consolidated Statements of Profit and Loss.
The derivative complied with the criteria required for hedge accounting. See further details in notes 4(i).
(2)Derivative financial instruments at fair value through profit and loss
The Group has contracted several forward exchange rate hedges to partially cover the foreign currency value of intercompany loans. Since the Group has chosen not to apply hedge accounting, the gains or losses resulting from changes in the fair value of the derivative are recognized directly under the heading ‘Fair Value Change in Financial Instruments’ in the Consolidated Statements of Profit and Loss. As of December 31, 2025, the Group recognized a net financial income of Euros 35 million (Euros 16 million financial expense as of December 31, 2024).
(3)Electricity derivative
At the beginning of 2023, the Company contracted a hedge on the variation of the price of electricity. This contract has served in its entirety to cover the purchase price of electricity against potential market price increases. The energy price hedging derivatives meet the requirements to apply hedge accounting, so the variations in the value of this financial instrument are recorded (by the net amount of taxes) in equity.
The movement in derivative financial instruments is as follows:
Changes in fair value recognized in equity
Transfer to profit or loss
Collections / Payments
e)Capital management
The directors’ policy is to maintain a solid capital base in order to ensure investor, creditor and market confidence and sustain future business development. The board of directors defines and proposes the level of dividends paid to shareholders.
The capital structure is periodically reviewed through the preparation of strategic plans focused mainly on a sequential improvement of EBITDA (Earnings before interest, tax, amortization and depreciation), generation of operating cash and discipline in the allocation of capital; with the objective and commitment to reduce the leverage ratio.
In accordance with the senior secured debt contract, the Group is subject to compliance with some covenants. At 31 December 2025 and 2024, the Group complies with the covenants in the contract.
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The credit rating of the Group is as follows:
December 2025
Moody’s Investors
Corporate rating
B2
B1
Senior Unsecured debt
Caa1
Perspective
Positive
Standard & Poor’s
BB-
B
Stable
Fitch Ratings
B+
BB
B-
The Parent held Class A and B treasury stock equivalent to 1.02% of its capital at 31 December 2025 (1.04% at 31 December 2024).
a)Group balances with related parties
Details of balances with related parties at 31 December 2025 are a follows:
Associates
Other related parties
Receivables
Current contractual assets
Guarantee deposits
Total debtors
Creditors
Debts
Total creditors
Details of balances with related parties at 31 December 2024 are as follows:
215
F-125
The heading “Receivables” corresponding to associates includes outstanding balances from sales to associated companies, mainly corresponding in 2025 to Grifols Egypt for Plasma Derivatives S.A.E. (Euros 33 million mainly corresponding in 2024 to Grifols Egypt for Plasma Derivatives S.A.E. and Euros 206 million in 2023 corresponding to Anhui Tonrol Pharmaceutical Co. (subsidiary of the Shanghai RAAS Blood Products, Co. Ltd. Group)).
The heading “Loans” mainly includes a loan signed by Scranton Enterprises BV. with the Group on 28 December 2018 for an initial amount of US Dollars 95 million (Euros 87 million) which maturity has been extended to 28 June 2027 (previously December 2025) (see note 11) related to the payment of the sale of the shares of BPC Plasma, Inc. and Haema, GmbH (see note 2). As of 31 December 2025 and 2024, the heading includes an additional amount of Euros 15 million arranged during 2023 under the same conditions as the initial loan (see note 31(b)). As of 31 December 2025, the recorded amount stands at Euros 124 million, including accrued and capitalized interest to date (Euros 132 million as of 31 December 2024).
Furthermore, it includes the cash-pooling financing agreement that BPC Plasma, Inc and Haema, GmbH have with Scranton Plasma, BV with maturity in 2027 (see note 11).
The heading “Loans” corresponding to associates includes a loan granted to Grifols Canada Plasma, Inc. as part of its acquisition agreement (see Note 10).
The heading of “debts” includes an amount of Euros 8 million at 31 December 2025(Euros 9 million at 31 December 2024) corresponding to the balance of bearer promissory notes issued by the Group company Instituto Grifols, S.A. These promissory notes are due on 5 May 2026 and 2025, respectively, with a nominal value of Euros 3,000 each, and an annual nominal interest of 4.25% (5% in 2024).
The heading “Guarantee deposits” corresponding to associates includes a pledged deposit amounting to US Dollars 10 million, which forms part of the US Dollar 50 million guarantee granted by the Group to Grifols Egypt for Plasma Derivatives S.A.E., securing a contract entered into by said entity with a financial institution (see note 11).
b)Group transactions with related parties
Group transactions with related parties during 2025 are as follows:
Key management
Other related
Board of directors
personnel
parties
of the Company
Purchases
Rendering of services
Remuneration
Payments for rights of use
Dividends received/(paid)
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Group transactions with related parties during 2024 were as follows:
Acquisition of assets
Group transactions with related parties during 2023 were as follows:
472
(266)
(200)
“Net sales” includes sales to associated companies mainly corresponding to Grifols Egypt for Plasma Derivatives S.A.E. (Euros 38 million in 2025, Euros 231 million and Euros 450 million corresponding to Anhui Tonrol Pharmaceutical Co. (subsidiary of the Shanghai RAAS Blood Products, Co. Ltd. Group) in 2024 and 2023).
“Other service expenses” includes an amount of Euros 6 million corresponding to contributions to nonprofit entities in 2025 (Euros 4 million in 2024 and Euros 2 million in fiscal year 2023).
The dividends received in 2024 and 2023 correspond to the former associated company Shanghai RAAS Blood Products Co. Ltd.
“Acquisition of assets” includes the acquisition of Haema Plasma Kft for Euros 35 million in 2024 that was effected through the cancellation of a balance receivable that the Group had with Haema GmbH. This balance was transferred to Scranton Plasma B.V. and settled through the cash-pooling financing agreement held by these companies.
Mr. Victor Grifols Roura, director representing shareholder’s during 2023 and who resigned from his position as director in December 2023, received remuneration in 2023 of Euros 1 million.
F-127
The composition of the transactions with other related parties for in 2025, 2024 and 2023 is as follows:
Related parties
Concept
Interest Credits
Finance Agreements: Credits
Scranton Plasma B.V.
Interest Cash-pooling
Finance Agreements: Cash-pooling
Dividends paid/received
Shares acquisition
Scranton Plasma BV
h)
Probitas Fundación Privada
Management and collaboration contracts
Fundación Privada Victor Grifols Lucas
Centurion Real State, S.A.U
Jose Antonio Grifols Lucas Foundation
Marca Grifols, S.L.
g)
Endo Operations Limited
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The Group has no advances or credits or obligations assumed on behalf of members of the Board of Directors or members of the key management staff as guarantees, nor pension and life insurance obligations in respect of former or current members of the Board of Directors or key members of management. In addition, certain managers and key management personnel have severance commitments (see note 29).
In July 2024, Scranton entered into a loan agreement with funds controlled or managed by Oaktree (the “Loan Agreement”) to refinance the loan that Scranton had initially obtained from banks in 2019. According to the terms of the Loan Agreement, this financing benefits from the following guarantees and security interest: (i) by a guarantee from BPC Plasma, Inc, (ii) a pledge of the shares of Haema GmbH and BPC Plasma Inc, and (iii) pledges over the assets of BPC Plasma Inc. In March 2025 and once the transformation of Haema AG into a limited liability company in the form of GmbH, following the terms of the Loan Agreement, Haema acceded to the Loan Agreement as a guarantor and granted security over its assets as collateral for the Loan Agreement.
c)Conflicts of interest concerning the directors
The Company’s directors and their related parties have not entered into any conflict of interest that should have been reported in accordance with article 229 of the revised Spanish Companies Act. The members of the Board and related persons.
(32)Subsequent events
The Group’s joint business arrangement with Ortho (QuidelOrtho), initiated over 40 years ago and originally focused on the development and production of HIV and HCV antigens, was terminated effective January 1, 2026, pursuant to a Settlement and Termination Agreement executed on April 11, 2026, as both businesses and the relevant market have significantly evolved over time. The parties agreed on a settlement amount of US Dollars 65 million to be paid by QuidelOrtho to the Group as a final and comprehensive settlement of all matters arising from the termination: US Dollars 25 million in Q2 2026, US Dollars 25 million in Q1 2027, and US Dollars 15 million in Q1 2028. Concurrently, the parties entered into a new multi-year Exclusive Supply Agreement under which the Group continues as exclusive supplier of antigens to Ortho, while retaining the right to supply antigens to third parties (including Abbott Laboratories, Siemens and OraSure Technologies) and to develop products independently, subject to customary intellectual property terms.
F-129
Subsequent to December 31, 2025, the Group continued to advance its plans to proactively refinance its senior debt maturing in 2027. On April 14, 2026, the Group entered into a new credit agreement with a syndicate of banks whereby such banks have agreed to extend certain credit facilities consisting of term loans of US Dollar 2 billion and Euros 1.25 billion, both maturing in April 2033, as well as a revolving credit facility of US Dollar 2.065 billion, maturing in November 2032. The proceeds of the term loans were are being used to fully repay the outstanding loans under the First Lien Credit Facilities and certain other debt.
Following approval by the Group’s Board, on March 24, 2026 it was announced that the Group will potentially pursue an initial public offering of a minority stake in its U.S. Biopharma business, subject to market conditions and applicable legal and regulatory requirements. The transaction is intended to support the Group’s strategic priorities, including debt reduction and investment in growth initiatives. Upon completion, Grifols S.A. would retain control of the U.S. business and remain listed in Spain, while the U.S. Biopharma entity would operate as a separately governed, U.S.-listed company with its own board and management team.
On March 16, 2026, the Group prepaid in full the outstanding amounts owed under the 2017 EIB Term Loan and 2018 EIB Term Loan for an amount of Euros 54 million, resulting in the termination of the EIB Term Loans. The Group is currently negotiating with the EIB the execution of the corresponding documentation for the cancellation of the security interest and guarantees granted in favor of the EIB to secure/guarantee the EIB Term Loans.
At the end of February 2026, tensions in the Middle East escalated on the back of military operations in the region. At the date of preparation of these consolidated financial statements, this situation persists and could affect the normal course of the Group’s operations in this area, as well as the overall conditions in international markets. Management is continuously monitoring these events and assessing their potential effects on the Group’s results and cash flows.
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APPENDIX I
Information on Group Companies, Associates and others for the years ended 31 December 2025, 2024 and 2023
Acquisition /
Registered
% shares
Office
date
Activity
Statutory Activity
Fully Consolidated Companies
Diagnostic Grifols, S.A.
Polígono LevanteCalle Can Guasch, s/n08150 Parets del Vallès(Barcelona) Spain
1987
Industrial
Development and manufacture of diagnostic equipment, instruments and reagents.
55.000
66.790
Instituto Grifols, S.A.
Plasma fractioning and the manufacture of haemoderivative pharmaceutical products.
99.998
0.002
Laboratorios Grifols, S.A.
1989
Production of glass- and plastic-packaged parenteral solutions, parenteral and enteral nutrition products and blood extraction equipment and bags.
Biomat, S.A.
Polígono Levante Calle Can Guasch, s/n 08150 Parets del Vallès (Barcelona) Spain
1991
Analysis and certification of the quality of plasma used by Instituto Grifols, S.A. It also provides transfusion centres with plasma virus inactivation services (I.P.T.H).
99.900
0.100
Grifols Engineering, S.A.
2000
Design and development of the Group’s manufacturing installations and part of the equipment and machinery used at these premises. The company also renders engineering services to external companies.
99.950
0.050
Biomat USA, Inc.
2410 Lillyvale AvenueLos Angeles (California)United States
2002
Procuring human plasma.
80.000
78.750
77.500
Grifols Biologicals, LLC.
5555 Valley BoulevardLos Angeles (California)United States
2003
Plasma fractioning and the production of haemoderivatives.
Grifols Australia Pty Ltd.
Unit 5/80 FairbankClayton SouthVictoria 3149Australia
2009
Distribution of pharmaceutical products and the development and manufacture of reagents fordiagnostics.
Medion Grifols Diagnostic AG
Bonnstrasse,93186 DügingenSwitzerland
Development and manufacturing activities in the area of biotechnology and diagnostics.
Grifols Therapeutics, LLC.
4101 Research Commons(Principal Address),79 T.W. Alexander Drive,Research Triangle Park,North Carolina 277709,United States
2011
F-131
Grange Castle Business Park,Grange Castle, Clondalkin,Dublin 22,Ireland
2012
Packaging, labelling, storage, distribution, manufacture and development of pharmaceutical productsand rendering of financial services to Group companies.
Parque Tecnológico de Vizcaya, Edificio 504 48160 Derio (Vizcaya)Spain
2013
Development, production and commercialisation of biotechnological solutions.
99.990
0.010
Grifols Diagnostics Solutions, Inc.
4560 Horton Street94608 Emeryville, CaliforniaUnited States
Manufacture and sale of blood testing products
11.790
Grifols Worldwide Operations USA Inc.
13111 Temple Avenue, City ofIndustry, California 91746-1510United States
2014
Manufacture, warehousing, and logistical support for biological products.
Grifols Asia Pacific Pte, Ltd
501 Orchard Road nº20-01 238880 Wheelock Place, Singapore
Commercial
Distribution and sale of medical and pharmaceutical products.
Distribution and sale of reagents, chemical products and other pharmaceutical specialities, and of medical and surgical materials, equipment and instruments for use by laboratories and health centres.
99.999
0.001
Grifols Portugal Productos Farmacéuticos e Hospitalares, Lda.
Rua de Sao Sebastiao, 2 Zona Industrial Cabra Figa 2635-448 Rio de Mouro Portugal
1988
Import, export and commercialisation of pharmaceutical and hospital equipment and products, particularly Grifols products.
Grifols Chile, S.A.
Avda. Americo Vespucio, 2242 Comuna de Conchali Santiago de Chile Chile
1990
Development of pharmaceutical businesses, which can involve the import, production, commercialisation and export of related products.
99.000
1.000
Grifols USA, LLC.
2410 Lillyvale Avenue Los Angeles (California)United States
Distribution and marketing of company products.
Grifols Argentina, S.A.
Bartolomé Mitre 3690/3790, CPB1605BUT Munro Partido de Vicente Lopez Argentina
Clinical and biological research. Preparation of reagents and therapeutic and diet products. Manufacture and commercialisation of other pharmaceutical specialities.
95.010
4.990
Grifols s.r.o.
Calle Zitna,2 Prague Czech Republic
1992
Purchase, sale and distribution of chemical-pharmaceutical products, including human plasma.
Grifols (Thailand) Ltd
191 Silom Complex Building, 21st Follor, Silom Road, Silom, Bangrak10500 BangkokThailand
Import, export and distribution of pharmaceutical products.
48.000
F-132
Level 18, The Gardens NorthTower, Mid Valley City, Lingkaran Syed Putra 59200 Kuala Lumpur Malaysia
Distribution and sale of pharmaceutical products.
49.000
Grifols International, S.A.
Polígono Levante Calle Can Guasch, s/n 08150 Parets del Vallès (Barcelona) Spain
1997
Coordination of the marketing, sales and logistics for all the Group’s subsidiaries operating in othercountries.
Grifols Italia S.p.A
Via Carducci, 62d 56010 Ghezzano Pisa, Italy
Purchase, sale and distribution of chemical-pharmaceutical products.
Gregory Rowcliffe & Milners, 1 Bedford Row, London WC1R 4BZ United Kingdom
Distribution and sale of therapeutic and other pharmaceutical products, especially haemoderivatives.
Grifols Brasil, Lda.
Rua Umuarama, 263 Condominio Portal da Serra Vila Perneta CEP 83.325-000 Pinhais Paraná, Brazil
1998
Import and export, preparation, distribution and sale of pharmaceutical and chemical products for laboratory and hospital use, and medical-surgical equipment and instruments.
Grifols France, S.A.R.L.
Arteparc, Rue de la Belle du Canet, Bât. D, Route de la Côte d’Azur, 13590 Meyreuil France
1999
Commercialisation of chemical and healthcare products.
Grifols Polska Sp.z.o.o.
Grzybowska 87 street00-844 Warsaw, Poland
Distribution and sale of pharmaceutical, cosmetic and other products.
Grifols México, S.A. de C.V.
Calle Eugenio Cuzin, nº 909-913 Parque Industrial Belenes Norte 45150 Zapopán Jalisco, Mexico
1993
Production, manufacture, adaptation, conditioning, sale and purchase, commissioning, representationand consignment of all kinds of pharmaceutical products and the acquisition of machinery, equipment, raw materials, tools, movable goods and property for the aforementioned purposes.
Grifols Nordic, AB
Sveavägen 16611346 StockholmSweden
2010
Research and development, production and marketing of pharmaceutical products, medical devices and any other asset deriving from the aforementioned activities.
Carrera 7 No. 71 52 Torre B piso 9Bogotá. D.C.Colombia
Sale, commercialisation and distribution of medicines, pharmaceutical (including but not limited to haemoderivatives) and hospital products, medical devices, biomedical equipment, laboratory instruments and reagents for diagnosis and/or healthcare software.
Grifols Deutschland GmbH
Lyoner Strasse 15, D- 60528 Frankfurt am Main Germany
Procurement of the official permits and necessary approval for the production, commercialisation and distribution of products deriving from blood plasma, as well as the import, export, distribution and sale of reagents and chemical and pharmaceutical products, especially for laboratories and health centres and surgical and medical equipment and instruments.
F-133
Grifols Canada, Ltd.
5060 Spectrum Way, Suite 405(Principal Address)Mississauga,Ontario L4W 5N5 Canada
Distribution and sale of biotechnological products.
Grifols Pharmaceutical Technology (Shanghai) Co., Ltd.
Unit 901-902, Tower 2, No.1539, West Nanjing Rd.,Jing’an District, Shanghai200040China
Pharmaceutical consultancy services (except for diagnosis), technical and logistical consultancyservices, business management and marketing consultancy services.
Grifols (H.K.), Limited
Units 1505-7 BerKshire House,25 Westlands RoadHong Kong
Distribution and sale of diagnostic products.
Grifols Japan K.K.
Hilton Plaza West Office Tower,19th floor. 2-2, Umeda 2-chome,Kita-ku Osaka-shiJapan
Research, development, import and export and commercialisation of pharmaceutical products, devices and diagnostic instruments.
Grifols India Healthcare Private Ltd
Regus Business CentrePvt.Ltd.,Level15,Dev Corpora,Plot No.463,Nr. KhajanaEast.Exp.Highway,Thane (W),Mumbai - 400604,MaharashtraIndia
99.984
0.016
Grifols Diagnostics Equipment Taiwan Limited
8F., No.367, Fuxing N. RD.,Songshang Dist., Taipei City10543, Taiwan
2016
Grifols Viajes, S.A.
Can Guasch, 208150 Parets del VallèsBarcelona, Spain
1995
Services
Travel agency exclusively serving Group companies.
Squadron Reinsurance Designated Activity Company
The Metropolitan Building, 3rd Fl.James Joyce Street,DublinIreland
Reinsurance of Group companies’ insurance policies.
Grifols Shared Services North America, Inc.
2410 Lillivale Avenue90032 Los Angeles, CaliforniaUnited States
Support services for the collection, manufacture, sale and distribution of plasma derivatives and relatedproducts.
Avenida Vía Hispanidad, número 21Zaragoza, España
Research
Creation and commercialisation of a blood diagnosis kit for the detection of Alzheimer’s and development of effective immunotherapy (vaccine) against this disease.
77.118
75.880
Grange Castle BusinessPark, Grange Castle,Clondalkin, Dublin 22,Ireland
Biotechnology research and development
Kiro Grifols S.L
Polígono Bainuetxe, 5, 2ºplanta, Aretxabaleta,GuipúzcoaSpain
Development of machines and equipment to automate and control key points of hospital processes, and hospital pharmacy processes.
99.700
0.300
F-134
Aigües Minerals de Vilajuiga, S.A.
Carrer Sant Sebastià, 2, 17493 Vilajuïga, Girona, Spain
2017
Collection and use of mineral-medicinal waters and obtaining of all necessary administrative concessions for the optimum and widest use of these.
Grifols Bio Supplies Inc. (before Interstate Blood Bank, Inc.)
5700 Pleasantville RoadMemphis, TennesseeUnited States
Procurement of human plasma.
Haema, GmbH (formerly Haema, AG)
LandsteinerstraBe 1, 04103 Leipzig - Germany
2018
BPC Plasma, Inc (formerly Biotest Pharma Corp)
901 Yamato Rd., Suite101, Boca Raton FL33431 - United States
Bajcsy-Zsilinszky út 12.,1051 Budapest (Hungría)
2021
80.400
Alkahest, Inc.
3500 South DuPont Hwy,Dover, County of KentUnited States
2015
Development of novel plasma-based products for the treatment of cognitive decline in aging and disorders of the central nervous system (CNS).
Colmarer Strasse 22,60528 Frankfurt am Main- Germany
50.000
Plasmavita Healthcare II GmbH
Garnisongasse 4/12, 1090Vienna, Austria
Grifols Canada Therapeutics Inc. (formerly Green Cross Biotherapeutics; Inc)
2911 Avenue Marie Curie, Arrondissement de Saint-Laurent, Quebec Canada
2020
Conducting business in Pharmceuticals and Medicines Industry
0.020
99.980
Grifols Laboratory Solutions, Inc
Corporation Trust Center,1209, Orange Street,Wilmington, New Castle Country, Delaware, 19801United States
Engage in any lawful act or activity for which corporations may be organized under the General Corporation Law of Delaware
Grifols Korea Co., Ltd.
302 Teheran-ro, Gangnam-gu, Seoul (Yeoksam-dong)Korea
Import, export of diagnostic in vitro products and solutions.
Grifols Middle East & Africa LLC
Office No. 534, 5th floor, NamaaBuilding No.155, Ramses Extension Street, Al Hay Al Sades, Nasr City, CairoEgypt
Providing consultation (except for those stipulated in Article 27 of the Capital Market Law and its executive regulations) and carry out those commercial activities that are permitted by the law.
GigaGen Inc.
407 Cabot RoadSouth San Francisco, CA 94080, United States
Engage in any lawful act or activity for which corporations may be organized under General Corporation Law.
C/ Prat de la Creu, 68-76, Planta 3ª, Edifici Administratiu del Comú d’Andorra la VellaAndorra
Constitution, development and management of operations of a research and development center in all areas of immnology, dedicated to find possible solutions for therapeutic applications.
F-135
251 Little Falls Drive, Wilmington, New Castle County, 19808, Delaware United States
Engage in any lawful business permitted by the Act or the laws of any jurisdiction in which the Company may do business.
Biomat Holdings LLC
2410 Grifols Way, Los Angeles, California, 90032, United States.
Administration and financing services to Immunotek donor centers.
Biomat Holdco, LLC.
251 Little Falls Drive, Wilmington, New Castle County, Delaware, 19808United States
Engage in any lawful act or activity for which corporations may be organized under General Corporation Law of Delaware.
Biomat Newco, Corp.
91.400
90.000
88.600
Grifols Canada Plasma II, Inc. (formerly Prometic Plasma Resources, Inc.)
2911 Avenue Marie-Curie,Montréal, Quebec H4S 0B7,Canadá
Grifols Canada Plasma – Ontario Inc. (formerly Canada Inc.)
5060 Spectrum Way, STE 405,Mississauga,Ontario L4W 5N5,Canada
Administration, operating management and control services of plasma recollecting centers, directly or indirectly, through its affiliates.
Albimmune, S.L.
Parque Empresarial Can Sant Joan, Avda de la Generalitat, 152-156, Sant Cugat del Vallès, 08174, Barcelona España
The purpose of the company is the research, development and exploitation of a project on the application of the use of albumin as a medicine
51.000
Biotest, AG
Landsteinerstr. 5, D-63303 Dreieich, Germany
Development, manufacture and distribution of biological, chemical, pharmaceutical, human and veterinary medical, cosmetic and dietary products as well as containers, devices, machines and accessories for medical, pharmaceutical and analytical purposes, as well as research in these fields. Furthermore the activity (especially research development, production and distribution) in the field of plant protection and plant breeding, the field of testing and purification of soil, water and air and in the field of products, materials and techniques used in space.
26.195
54.205
24.700
45.480
Biotest Austria, GmbH
Einsiedlergasse 58, A-1050, Vienna, Austria
Distribution of pharmaceutical products.
70.180
Biotest Italia, S.R.L. (merged with Grifols Italia S.p.A)
Via Leonardo da Vinci 43, I-20090 Trezzano sul Naviglio MI, Italy
Biotest (UK) Ltd. (merged with Grifols UK, Ltd.)
17 High Street, B31 2UQ Longbridge Birmingham, United Kingdom
Biotest (Schweiz) AG
Schützenstrasse 17, CH-5102 Rupperswil, Switzerland
Biotest Hungaria Kft
Torbágy utca 15/ A, Törökbálint 2045, Hungary
Biotest Farmacêutica LTDA (merged with Grifols Brasil Ltda.)
Rua José Ramos Guimarães, 49 A Centro, 12955-000, Bom Jesus dos Perdões – SP, Brasil
F-136
Biotest Hellas M.E.P.E.
45 Michalakopoulou Str., 11528 Athens, Greece
Research and development of solutions in the Biopharma area.
Biotest France SAS (merged with Grifols France S.A.R.L.)
45/47 rue d’Hauteville, 75010 Paris, France
The purpose of the company is to act as an agent and support the group companies.
Biotest Pharmaceuticals Ilaç Pazarlama Anonim Sirketi
Nishstanbul, Cobançesme Mahallesi, 34197 Bahçeliever, Istanbul, Turkey
Biotest Medical, S.L.U. (merged with Grifols Movaco, S.A.)
C/ Frederic Mompou, nº 5, 6º 3ª A, 08960 Sant Just Desvern, Barcelona, Spain
Biotest Pharma, GmbH
Carry out the development and production activities in the Biopharma area.
Biotest Lux S.à.r.l.
17, Boulevard F.W. Raiffeisen L-2411 Luxembourg
Providing financing and centralisation of services for Biotest companies.
Biotest Grundstücksverwaltungs GmbH
Management of own assets.
Plasma Service Europe GmbH
Cara Plasma s.r.o.
Jungmannova 745/24 - Nové Město, 110 00 Praha 1, Czech Republic
Plazmaszolgálat Kft
Colmarer Strasse 22, 60528 Frankfurt am Main Alemania
Participating, collaborating and directing the management of companies and other businesses, in particular as a general partner of Biotest GmbH & Co. KGaA.
Biotest Management GmbH
Undertaking responsibility and personal management, as a general partner of Biotest GmbH & Co. KGaA, to promote the corporate purpose of its investee company and to provide it with business management services
Grifols Biotest Holdings GmbH
Colmarer Str. 22, 60528 Frankfurt am Main, Germany
Management of own assets as well as the acquisition, sale, holding and management of shares in other companies in Germany and abroad in the company’s own name and on its own account (not third parties), in particular in Biotest AG with registered offices in Dreiech.
AlbaJuna Therapeutics, S.L
Hospital Germans Trias i Pujol, carretera de Canyet, s/n, Badalona, Spain
Development and manufacture of therapeutic antibodies against HIV.
Equity-accounted investees and others
Mecwins, S.L. (no longer associated)
Avenida Fernandos Casas Novoa, 37 Santiago de Compostela, Spain
Research and production of nanotechnological, biotechnological and chemical solutions.
24.590
Medcom Advance, S.A (dissolved)
Av. Roma, 35 Entresuelo 1, 08018 Barcelona; Spain
Research and development of nanotechnological solutions.
45.000
F-137
Shanghai RAAS Blood Products Co. Ltd. (no longer associated)
2009 Wangyuan Road, Fengxian District, Shanghai
Introducing advanced and applicable technologies, instruments and scientific management systems for manufacturing and diagnosis of blood products, in order to raise the production capacity and enhance quality standards of blood products to the international level.
26.580
Tolip El Narges Hotel, Teseen Streett, Fifth Settlement, CairoEgypt
Establish and operate a plasma fractionation plant, regardless of whether the plasma is collected locally or imported, as well as its filling and packaging.
Biotek America LLC (“ITK JV”)
1430 East Southlake Blvd Suite 200 Southlake TX 76092 Estados Unidos
Build and manage until the opening of donor plasma centers in the United States.
75.000
BioDarou PLC
Sarparast St., Italia St. Felestin Ave, 1416653163 Tehran, Iran
39.400
34.388
200-2010 Winston ParkDrive Oakville, ONL6H5P7, Canada
50.100
This appendix is part of note 2 from the consolidated financial statements.
F-138
APPENDIX II
(expressed in millions of Euros)
Estimated distributable profits until July 28, 2025
Estimated net income after taxes from the beginning of the fiscal year to July 28, 2025
Less, required allocation to legal reserve
Interim dividend distributed
Cash flow forecast for the period from July 28, 2025 to July 28, 2026:
Cash balance as of July 28, 2025
Projected colelctions
1,264
Projected payments, including interim dividend
-1,199
Projected cash balance as of July 28, 2026
F-139