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: 0-2022
Trinity Biotech plc
(Exact name of Registrant as specified in its charter and translation of Registrant’s name into English)
Ireland
(Jurisdiction of incorporation or organization)
IDA Business Park, Bray, County Wicklow, A98 H5C8, Ireland
(Address of principal executive offices)
Paul Murphy
Interim Chief Financial Officer
Tel: +353 1276 9800
Fax: +353 1276 9888
(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 (each representing 20‘A’ Ordinary Shares, par value US$0.0001)
TRIB
NASDAQ Global Market
Securities registered or to be registered pursuant to Section 12(g) of the Act: None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None
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:
374,206,640 Class ‘A’ Ordinary Shares (excluding Treasury Shares)
(as of December 31, 2025)
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.
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.
Yes ☒ No ☐
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, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):
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. ☐
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 issued
by 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).
This Annual Report on Form 20-F is incorporated by reference into our Registration Statements on Form S-8 File Nos. 333-182279,333-195232 and 333-253070 and our Registration Statements on Form F-3 File Nos. 333-286020, 333-267160, 333-280391 and 333-283273.
TABLE OF CONTENTS
Page
PRESENTATION OF FINANCIAL AND OTHER INFORMATION
1
MARKET, INDUSTRY AND OTHER DATA
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
PART I
2
Item 1
Identity of Directors, Senior Management and Advisers
Item 2
Offer Statistics and Expected Timetable
Item 3
Key Information
A.
Reserved
B.
Capitalization and Indebtedness
C.
Reasons for the Offer and Use of Proceeds
D.
Risk Factors
Item 4
Information on the Company
34
History and Development of the Company
Business Overview
Organizational Structure
53
Property, Plants and Equipment
Item 4A.
Unresolved Staff Comments
55
Item 5
Operating and Financial Review and Prospects
56
Operating Results
Liquidity and Capital Resources
67
Research and Development, Patents and Licenses, etc.
71
Trend Information
E.
Critical Accounting Policies and Estimates
Item 6
Directors, Senior Management and Employees
75
Directors and Senior Management
Compensation
77
Board Practices
78
Employees
79
Share Ownership
Item 7
Major Shareholders and Related Party Transactions
82
Major Shareholders
Related Party Transactions
83
Interests of Experts and Counsel
84
Item 8
Financial Information
85
Consolidated Statements and Other Financial Information
Significant Changes
Item 9
The Offer and Listing
Offer and Listing Details
Plan of Distribution
Markets
Selling Shareholders
Dilution
F.
Expenses of the Issue
Item 10
Additional Information
86
Share Capital
Memorandum and Articles of Association
Material Contracts
87
Exchange Controls
89
Taxation
Dividends and Paying Agents
95
G.
Statement by Experts
H.
Documents on Display
I.
Subsidiary Information
Item 11
Quantitative and Qualitative Disclosures about Market Risks
96
Item 12
Description of Securities Other than Equity Securities
97
PART II
Item 13
Defaults, Dividend Arrearages and Delinquencies
99
Item 14
Material Modification to the Rights of Security Holders and Use of Proceeds
Item 15
Controls and Procedures
Item 16
100
Item 16A
Audit Committee Financial Expert
Item 16B
Code of Ethics
Item 16C
Principal Accountant Fees and Services
Item 16D
Exemptions from the Listing Standards for Audit Committees
Item 16E
Purchases of Equity Securities by the Issuer and Affiliated Purchasers
Item 16F
Changes in Registrant’s Certifying Accountant
101
Item 16G
Corporate Governance
Item 16H
Mine Safety Disclosure
Item 16I
Disclosures Regarding Foreign Jurisdictions That Prevent Inspections
Item 16J
Insider Trading Policies
Item 16K
Cybersecurity
102
PART III
Item 17
Financial Statements
103
Item 18
Item 19
Exhibits
196
As used herein, references to “we”, “us”, “Trinity Biotech” or the “Group” in this Annual Report on Form 20-F (the “Annual Report”) shall mean Trinity Biotech plc and its subsidiaries. References to the “Company” in this Annual Report shall mean Trinity Biotech plc., the parent company. Our consolidated financial statements appearing in this Annual Report are prepared in accordance with International Financial Reporting Standards (“IFRS”) both as issued by the International Accounting Standards Board (“IASB”) and as adopted by the European Union (“EU”). The IFRS standards applied are those effective for accounting periods beginning January 1, 2025. Consolidated financial statements are required by Irish law to comply with IFRS as adopted by the EU which differ in certain respects from IFRS as issued by the IASB. These differences predominantly relate to the timing of adoption of new standards by the EU. However, as none of the differences are relevant in the context of Trinity Biotech, the consolidated financial statements for the periods presented comply with IFRS both as issued by the IASB and as adopted by the EU. We present our consolidated financial statements in U.S. Dollars and except as otherwise stated herein, all monetary amounts in this annual report have been presented in US Dollars. All references in this annual report to “Dollars” and “$” are to US Dollars, and all references to “Euro” or “€” are to European Union Euro. For presentation purposes all financial information, including comparative figures from prior periods, have been stated in round thousands, unless otherwise indicated.
Unless otherwise indicated, information contained in this Annual Report concerning our industry and the markets in which we operate, including our competitive position and market opportunity, is based on information from our own management estimates and research, as well as from industry and general publications and research, surveys and studies conducted by third parties. Management estimates are derived from publicly available information, our knowledge of our industry and assumptions based on such information and knowledge, which we believe to be reasonable. Our management estimates have not been verified by any independent source, and we have not independently verified any third-party information. In addition, assumptions and estimates of our and our industry’s future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in Item 3.D. “Risk Factors” below.
Statements made in this Annual Report concerning the contents of any contract, agreement or other document are summaries of such contracts, agreements or documents and are not complete descriptions of all of their terms. If we filed any of these documents as an exhibit to this Annual Report, you should read the document itself for a complete description of its terms, and the summary included herein is qualified by reference to the full text of the document which is incorporated by reference into this Annual Report.
This Annual Report contains statements that constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. These statements are neither historical facts nor assurances of future performance. Although we believe that these estimates and forward-looking statements are based upon reasonable assumptions, they are subject to numerous risks and uncertainties some of which are beyond our control and are made in light of information currently available to us.
In some cases, these forward-looking statements can be identified by words or phrases such as “believe,” “may,” “will,” “expect,” “estimate,” “could,” “should,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. Forward-looking statements contained in this Annual Report include, but are not limited to, statements about:
the development of our products;
the potential attributes and benefit of our products and their competitive position;
our ability to successfully commercialize, or enter into strategic relationships with third parties to commercialize, our products;
our estimates regarding expenses, future revenues, capital requirements and our need for additional financing;
statements of our plans and objectives;
our ability to acquire or in-licence new product candidates;
potential strategic relationships;
the duration of our patent portfolio;
the capabilities of our business operations;
expected future economic performance;
competition in our market; and
assumptions underlying statements regarding us or our business.
We operate in an evolving environment. New risks emerge from time to time, and it is not possible for our management to predict all risks, nor can we assess the effect of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
These forward-looking statements are subject to risks, uncertainties and assumptions, some of which are beyond our control. In addition, these forward-looking statements reflect our current views with respect to future events and are not a guarantee of future performance. Actual outcomes may differ materially from the information contained in the forward-looking statements as a result of a number of important factors, including, without limitation, the important risk factors set forth in Item 3.D. “Risk Factors” of this Annual Report.
The forward-looking statements made in this Annual Report relate only to events or information as of the date on which the statements are made in this Annual Report. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this Annual Report and the documents that we have filed as exhibits hereto completely and with the understanding that our actual future results or performance may be materially different from what we expect.
Item 1.
Not applicable.
Item 2.
Item 3.
SUMMARY OF RISK FACTORS
An investment in our securities involves a high degree of risk. Our business, financial condition or results of operations could be adversely affected by any of these risks. You should carefully consider the risks described below and, in the information, contained or incorporated by reference in this Annual Report. The risks and uncertainties we have described are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our operations. Past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results or trends in future periods. If any of these risks actually occurs, our business, business prospects, financial condition or results of operations could be seriously harmed. This could cause the trading price of our American Depositary Shares (“ADSs”) to decline, resulting in a loss of all or part of your investment.
Risks Related to our Business and Industry
We have a history of losses from operations and negative cash flows from operating activities, which may continue in the future.
We have incurred substantial debt, which could impair our flexibility and access to capital and adversely affect our financial position.
Failure to comply with the terms of the Credit Agreement could result in a default under its terms and, if uncured, could result in action against our pledged assets. Further, our variable rate indebtedness subjects us to interest rate risk, which could cause our debt service obligations to increase significantly.
Our ability to continue as a going concern depends on our ability to generate cash flows from operations and to conduct adequate financing activities. We expect we will require future additional capital.
We may encounter difficulties in realizing the potential financial or strategic benefits of business acquisitions.
Our long-term success depends upon the successful development and commercialization of new products, particularly in the biosensor area.
Our ability to sell products could be adversely affected by competition from new and existing diagnostic and biosensor products, and changing conditions in the diagnostic market, including reductions in government funding and sector consolidation.
Changes in funding for staffing and operations of the FDA and other government agencies could negatively impact our business.
Our exclusion from one or more HIV testing algorithms, or a delay in the implementation of a HIV testing algorithm, could adversely affect our business and financial results.
Global trade issues including import and export license requirements, trade sanctions, tariffs and international trade disputes could increase our costs and have a material adverse effect on our business.
Failure to achieve our financial and strategic objectives could have a material adverse impact on our business prospects.
Our products may in the future be subject to product recalls that could harm our reputation, business and financial results.
The large amount of intangible assets and goodwill recorded on our balance sheet may lead to significant impairment charges in the future.
Changes in global economic conditions may have a material adverse impact on our results.
Significant interruptions in production at our principal manufacturing facilities and/or third-party manufacturing facilities would adversely affect our business and operating results.
We are highly dependent on our senior management team and other key employees, and the loss of one or more of these employees or the inability to attract and retain qualified personnel as necessary could adversely affect our operations.
Cybersecurity risks, including cyberattacks or data breaches, could disrupt our operations, compromise sensitive data, and adversely affect our business.
Our sales and operations are subject to the risks of fluctuations in currency exchange rates.
Any pandemic similar to the Covid-19 outbreak could significantly disrupt our operations and adversely affect our results of operations.
3
Risks Related to Government Regulation
Clinical trials necessary to support future premarket submissions will be expensive and will require enrolment of suitable patients who may be difficult to identify and recruit.
If the third parties on whom we rely to conduct our pre-clinical studies and clinical trials and to assist in pre-clinical development do not perform as contractually required or expected, we may not be able to obtain regulatory approval or commercialize our products.
The results of our clinical trials may not support our product candidate claims.
Although the FDA’s 2024 effort to regulate laboratory developed tests was vacated by a federal court and subsequently rescinded in 2025, future legislative or regulatory actions could again impose premarket review or other compliance obligations on our laboratory developed tests, resulting in potential costs and delays.
If we are unable to obtain or fail to maintain regulatory approvals and clearances, or experience significant delays in obtaining, regulatory clearances or approvals for our future products or product enhancements, our ability to commercially distribute and market these products could suffer.
Failure to comply with FDA or other regulatory requirements may require us to suspend production of our products or institute a recall which could result in higher costs and a loss of revenues.
We are subject to export controls and economic sanctions laws, anti-corruption, anti-bribery and similar laws and our customers and distributors are subject to import and export controls that could subject us to liability if we are not in full compliance with applicable laws.
Changes in healthcare regulation could affect our revenues, costs and financial condition.
Our laboratory business could be harmed from the loss or suspension of a licence or imposition of a fine or penalties under, or future changes in, the law or regulations of the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), or those of other state or local agencies.
Compliance with regulations governing public company corporate governance and reporting is complex and expensive.
Risks Related to Our Intellectual Property
We may be unable to protect or obtain proprietary rights that we utilize or intend to utilize.
Our patent protection may not be sufficiently broad to compete effectively, the existing patents could be challenged, and trade secrets and confidential know-how could be obtained by competitors.
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Product infringement claims by other companies could result in costly disputes and could limit our ability to sell our products, and we may be involved in lawsuits to enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time consuming and unsuccessful.
Risks Related to Ownership of our American Depository Shares
Affiliates of Perceptive Advisors, our principal lender, and MiCo IVD Holdings, LLC (“MiCo”) own, or are entitled to acquire, a significant percentage of our share capital, which may give each of them significant influence over our management and affairs and may deter a change in control or other transaction that may be favorable to our shareholders.
Our failure to meet the continued listing requirements of Nasdaq could result in a de-listing of our ADSs and penny stock trading.
The market price of our ADSs has been, and may continue to be, highly volatile.
We will need additional capital in the future.
The conversion or exercise of our outstanding convertible instruments, share options, and warrants, and sales of ADSs under our committed equity financing, could significantly dilute the ownership interest of existing shareholders.
It could be difficult for U.S. holders of our ADSs to enforce any securities laws claims against us, our officers or directors in Irish Courts.
4
We have a history of losses from operations and negative cash flows from operating activities, which may continue in the future.
We have incurred net losses and negative cash flows from operating activities in the past two years and we may not be able to achieve or maintain profitability or positive cash flow in the future. We have incurred losses of US$37.4 million and US$31.8 million in the years ended December 31, 2025 and 2024, respectively, and had negative cash flows from operating activities of US$5.9 million and US$4.2 million, respectively.
We expect to continue as a going concern. Our ability to continue as a going concern depends on our ability to generate cash flows from operations and to conduct adequate financing activities. We believe that we have access to sufficient cash reserves for our operating needs for at least the next twelve months from the date of this Annual Report. However, if negative cash flow from operating activities persists in the long run, cash resources may become insufficient to satisfy our on-going cash requirements.
Additional funding may not be available on acceptable terms, or at all. In addition, we may not be able to access a portion of our existing cash, cash equivalents and investments due to market conditions. Further, as a result of geopolitical and macroeconomic events, including the Israel-Hamas and Russia-Ukraine wars, and the escalating wars in the Middle East involving the United States, Israel, Iran, and regional armed groups, alongside the ongoing uncertainty in respect of the imposition or escalation of U.S. tariffs on imported medical and laboratory equipment, components, or raw materials, the global credit and financial markets have experienced volatility and disruptions, including severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates, and uncertainty about economic stability. Any further escalation in the Middle East could also lead to additional sanctions, trade restrictions, or security‑related delays affecting the movement of medical equipment, components, or raw materials. If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly or more dilutive.
Expansion into new businesses may present operating and marketing challenges different from those we currently encounter, and we cannot assure that new business initiatives will be successful enough to justify the time, effort, and resources that we devote to them or ultimately achieve profitability. We initially announced the adoption of a transformation plan to improve the financial performance of our existing business in April 2024 and we continue to pursue and execute a strategic realignment of our continuing business. Although we have implemented, and are further advanced in implementing, key elements of this plan, including consolidating manufacturing, moving certain manufacturing activities offshore to improve operating margins, and centralizing significant business support functions in a lower‑cost shared services environment, there remains execution risk. We may encounter delays, cost overruns, operational disruption, or lower‑than‑expected efficiency gains, and we cannot assure you that these initiatives will ultimately deliver the anticipated financial benefits or that we will achieve our long‑term profitability goals.
Any of the above events could significantly harm our business, prospects, financial condition, and results of operations and cause the price of our ADSs to decline.
We have incurred substantial debt, which could impair our flexibility and access to capital and adversely affect our financial position.
As of December 31, 2025, we had total indebtedness of approximately US$141.3 million (carrying value under IFRS), consisting of a senior secured term loan (the “Term Loan” or “Credit Agreement”) from Perceptive Credit Holdings III, LP (“Perceptive”), a convertible note issued to MiCo IVD Holdings, LLC. (“MiCo”), a derivative liability related to warrants and conversion options issued to Perceptive, lease liabilities and a residual amount owing for an exchangeable note which was almost completely retired in 2022. In addition, a deferred consideration payment of US$5.0 million related to the acquisition of the biosensor assets of Waveform was extended to November 2025.
As of December 31, 2025, the Term Loan had an outstanding balance of US$108.0 million. Over recent years, the Group has increased its term loan borrowings through multiple amendments and restatements to the Credit Agreement, including the capitalisation of paid‑in‑kind interest, which has materially increased the outstanding principal balance.
On December 22, 2025, we entered into a series of agreements, including a further amendment to the Credit Agreement, under which our existing term loan obligations to Perceptive were restructured into a new senior convertible note representing the principal balance owed under the Credit Agreement at the time of approximately USD$95.8 million (IFRS carrying value US$93.3 million). This restructuring modified the terms, maturity profile and settlement mechanics of our indebtedness to Perceptive. Under these agreements, Perceptive may elect, at its discretion, to convert up to US$60.0 million outstanding principal under the Credit Agreement and US$12.5 million of other amounts owed to Perceptive into ADSs. The timing, volume and frequency of any conversions are entirely at Perceptive’s election, and the Company has no control over whether, when, or to what extent such conversions may occur. The Second Amendment also provided for an additional US$5.0 million in new term loan borrowing.
Following this restructuring, our total indebtedness as of December 31, 2025 was approximately US$141.3 million (carrying value under IFRS), including the Convertible Note, the MiCo convertible note, derivative liabilities relating to Perceptive warrants, lease liabilities, and remaining exchangeable note balances.
5
In connection with MiCo’s investment in 2022, we issued MiCo a seven-year, unsecured junior convertible note of US$20.0 million, The convertible note has an interest rate of 1.5% and interest is payable quarterly. The convertible note mandatorily converts into ADSs if the volume weighted average price of our ADSs is at or above US$16.20 for any five consecutive NASDAQ trading days. Based on public filings, we understand that on December 2, 2025, MiCo was acquired by AI N M NET LTD as a result of a share purchase agreement with Dayli Trinity Holdings Limited.
The convertible note is immediately repayable at par together with any accrued interest, if the Company or any of its material subsidiaries ceases or threatens to cease carrying on its business or a part of its business which is material to the Group. However, subject to the terms of an Investor Subordination Agreement between Perceptive and MiCo, MiCo may not, without the prior written consent of Perceptive, take any enforcement action with respect to the convertible note. Such enforcement actions include amongst other things any MiCo action to enforce payment of or to collect the whole or any part of the convertible note.
As a result of the debt we have incurred, we will need to raise capital in one or more debt or equity offerings to fund our operations and obligations. There can be no assurance, however, that we will be successful in raising the necessary capital or that any such offering will be available to us on terms acceptable to us, or at all. If we are unable to raise additional capital that may be needed on terms in sufficient amounts or on terms acceptable to us, it could have a material adverse effect on our company and we may have to significantly delay, scale back or discontinue our deliveries under our outstanding customer purchase orders or the development or commercialization of one or more of our products or one or more of our other research and development initiatives, sell assets and/or cease trading.
Our debt may:
require us to use a substantial portion of our cash flow from operations to make debt service payments;
limit our ability to use our cash flow or obtain additional financing for working capital, capital expenditures, acquisitions or other general business purposes;
limit our flexibility to plan for, or react to, changes in our business and industry;
result in dilution to our existing shareholders in the event we issue equity to fund our debt obligations;
place us at a competitive disadvantage compared to our less leveraged competitors; and
increase our vulnerability to the impact of adverse economic and industry conditions.
To the extent we are unable to repay our debt as it becomes due with cash on hand or from other sources, we will need to refinance our debt, sell assets or repay the debt with the proceeds from equity offerings in order to continue in business. Additional indebtedness or equity financing may not be available to us in the future for the refinancing or repayment of existing debt, or if available, such additional debt or equity financing may not be available on a timely basis, or on terms acceptable to us and within the limitations specified in our then existing debt instruments. In addition, in the event we decide to sell additional assets, we can provide no assurance as to the timing of any asset sales or the proceeds that could be realized by us from any such asset sale. Our ability to obtain additional funding may determine our ability to continue as a going concern.
The failure to comply with the terms of the credit agreement with Perceptive could result in a default under its terms and, if uncured, could result in action against our pledged assets.
The Term Loan is secured by substantially all of our property and assets, including our equity interests in our subsidiaries. The credit agreement governing the Term Loan (the “Credit Agreement”) contains a financial covenant requiring that we maintain agreed levels of unrestricted cash, which must be held in one or more accounts subject to the security interests of the lenders under the Credit Agreement. In addition, the Credit Agreement contains covenants that restrict our ability to finance future operations or capital needs or to engage in other business activities.
The Credit Agreement restricts the ability of our company and the restricted subsidiaries to, among other things:
incur, assume or guarantee additional indebtedness;
repurchase capital stock;
make other restricted payments, including paying dividends and making investments;
create liens;
sell or otherwise dispose of assets, including capital stock of subsidiaries;
enter into agreements that restrict dividends from subsidiaries;
acquire another company or business or enter into mergers or consolidations;
enter into certain inbound and outbound licenses of intellectual property, subject to certain exceptions; and
enter into transactions with affiliates.
6
A breach of the revenue covenant or any other covenant in the Credit Agreement would result in a default under the Credit Agreement. Upon an event of default under the Credit Agreement, the lender could elect to declare all amounts outstanding thereunder, together with accrued interest, to be immediately due and payable. In such an event, there can be no assurance that we would have sufficient liquidity to fund payment of the amounts that would be due under the Credit Agreement or that, if such liquidity were not available, we would be successful in raising additional capital on acceptable terms, or at all, or in completing any other endeavor to continue to be financially viable and continue as a going concern. If we were unable to pay such amounts due under the Credit Agreement, the lenders could proceed against the collateral securing the loan. Our inability to raise additional capital on acceptable terms in the near future, whether for purposes of funding payments required under the Credit Agreement or providing additional liquidity needed for our operations, could have a material adverse effect on our business, prospects, results of operations, liquidity and financial condition.
Our variable rate indebtedness subjects us to interest rate risk, which could cause our debt service obligations to increase significantly.
Borrowings under our Credit Agreement are at a variable rate of interest and expose us to interest rate risk. On January 30, 2024, we amended the Credit Agreement to reduce the base rate of interest by 2.5% to 8.75%. The Term Loan accrues interest at an annual rate equal to 8.75% plus the greater of (a) Term SOFR (Secured Overnight Financing Rate) or (b) 4.0% per annum. Over recent years, we have repeatedly increased our term loan borrowings and paid interest in kind through multiple amendments and restatements to the Credit Agreement, which have materially increased the outstanding principal balance.
If interest rates increase, our debt service obligations on the variable rate indebtedness will increase, and our net income and cash flows, including cash available for servicing our indebtedness, would correspondingly decrease.
As of December 31, 2025, the total outstanding amount of our variable rate debt was US$108.0 million.
Our anticipated annual cash interest expense on US$108.0 million variable rate debt at the current rate of approximately 12.75 percent would be approximately US$13.8 million. Every one percent increase in the interest rate results in additional annual interest payable of approximately US$1.1 million, based on the current amount of indebtedness.
Our ability to continue as a going concern depends on our ability to generate cash flows from operations and to conduct adequate financing activities. We expect we will require future additional capital.
Our future liquidity and ability to meet our future capital requirements will depend on numerous factors, including, but not limited to, the following:
The success of our research and product development efforts, in particular the significant development effort required to develop and commercialise the biosensor technology, including the continuous glucose monitoring technology acquired in January 2024;
The time, cost and degree of success of conducting clinical trials and obtaining regulatory approvals;
The costs and timing of expansion of sales and marketing activities;
The timing and size of any repayment requirements for existing debt obligations;
The timing and success of the commercial launch of new products;
The extent to which we gain or expand market acceptance for existing, new or enhanced products;
The costs and timing of the expansion of our manufacturing capacity;
The magnitude of capital expenditures;
Changes in existing and potential relationships with distributors and other business partners;
The costs involved in obtaining and enforcing patents, proprietary rights and necessary licences;
The costs and liability associated with patent infringement or other types of litigation;
The costs related to, and the success of, our operational efficiency focused activities;
Competing technological and market developments; and
The scope and timing of strategic acquisitions.
If additional financing is needed, we may seek to raise funds through the sale of equity or other securities or through bank borrowings. There can be no assurance that financing through the sale of securities, bank borrowings or otherwise will be available to us on satisfactory terms, or at all.
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We may encounter difficulties in realizing the potential financial or strategic benefits of recent business acquisitions. We expect to make additional acquisitions in the future that could disrupt our operations and harm our operating results.
A significant part of our business strategy is to pursue acquisitions and other initiatives based on a strategy centered on adding complementary solutions to our portfolio—all while we seek to ensure our continued high quality of services and product delivery. We have made numerous acquisitions including the acquisition in 2024 of the biosensor assets of Waveform, and intend to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring (“CGM”) product. During 2024, we also acquired Metabolomic Diagnostics which will grow our presence in the maternal health market, and we also entered the oncology space with the acquisition of Epicapture Limited.
Mergers and acquisitions of companies and assets are inherently risky and subject to many factors outside of our control and no assurance can be given that our future acquisitions will be successful and will not adversely affect our business, operating results, or financial condition. In the future, we may seek to acquire or make strategic investments in complementary businesses, technologies, services or products, or enter into strategic partnerships or alliances with third parties in order to expand our business. Failure to manage and successfully integrate such acquisitions could materially harm our business and operating results. Prior acquisitions have resulted in a wide range of outcomes, from successful introduction of new products, technologies and professional services to a failure to do so. There can be no assurance that new product enhancements will be made in a timely manner or that pre-acquisition due diligence will have identified all possible issues that might arise with respect to such products. If we acquire other businesses, we may face difficulties, including:
Difficulties in integrating the operations, systems, technologies, products, and personnel of the acquired businesses or enterprises;
Diversion of management’s attention from normal daily operations of the business and the challenges of managing larger and more widespread operations resulting from acquisitions;
Integrating financial forecasting and controls, procedures and reporting cycles;
Potential difficulties in completing projects associated with in-process research and development;
Difficulties in entering markets in which we have no or limited direct prior experience and where competitors in such markets have stronger market positions; and
Insufficient revenue to offset increased expenses associated with acquisitions.
Our long-term success depends upon the successful development and commercialization of new products, particularly in the biosensor area.
Our long-term viability and growth will depend upon the successful discovery, development and commercialization of new and enhanced products from our activities. In order to remain competitive, we are committed to significant expenditures on research and development (“R&D”) and the commercialization of new or enhanced products. The R&D process generally takes a significant amount of time from product inception to commercial launch. However, there is no certainty that this investment in research and development will yield technically feasible or commercially viable products. We may have to abandon a new or enhanced product during its development phase after our investment of substantial time and money. During the fiscal years ended December 31, 2025, 2024 and 2023, we incurred US$9.0 million, US$10.9 million and US$1.8 million, respectively, in capitalised R&D expenses. Included in the US$6.1 million R&D expenses in 2025, we capitalised borrowing costs of US$2.9 million, in line with IAS 23. Due to the acquisition of the biosensor technology of Waveform in January 2024, we expect to incur significantly higher costs related to our research and development activities for the foreseeable future.
Successful products require significant development and investment, including testing to demonstrate their performance capabilities, cost-effectiveness or other benefits prior to commercialization. In addition, unless exempt, regulatory clearance or approval must be obtained before our medical device products may be sold. Additional development efforts on these products may be required before we are ready to submit applications for marketing authorisation to any regulatory authority. Regulatory authorities may not clear or approve these products for commercial sale or may substantially delay or condition clearance or approval. In addition, even if a product is successfully developed and all applicable regulatory clearances or approvals are obtained, there may be little or no market for the product. Accordingly, if we fail to develop and gain commercial acceptance for our products, or if we have to abandon a new product during its development phase, or if competitors develop more effective products or a greater number of successful new products, customers may decide to use products developed by our competitors. This would result in a loss of revenues and adversely affect our results of operations, cash flow and business.
Our future growth in the U.S. is dependent in part on the U.S. Food and Drug Administration (“FDA”) clearance of products. If FDA clearance is delayed or not achieved for these products, it could have a material impact on the future growth of our business.
Similarly, future growth outside of U.S. is dependent on clearance of products by the relevant regulatory authorities in those countries
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Our ability to sell products could be adversely affected by competition from new and existing diagnostic and biosensor products, and changing conditions in the diagnostic market.
We have invested in research and development but there can be no guarantees that our R&D programmes will succeed and will not be rendered technologically obsolete or financially non-viable by the technological advances of our competitors, which would also adversely affect our existing product lines and inventory. Our main competitors (and their principal products with which we compete) include: Premier (First response™), Chembio (Stat-Pak™, DPP HIV-Syphilis), Abbott (Determine™, SD BioLine™, Abon™, Afinion™, Architect™, FreeStyle Libre™), SD Biosensor (Standard Q), Beijing Wantai Biological Pharmacy (Wantai), Roche (Cobas, TinaQuant 3™), Bio-Rad (Variant 2™, Variant 2 Turbo™, D 100™, BioPlex 2200) Tosoh (G8™ and G11™), Arkray 8180™, Siemens DCA™, Sebia (Capyllaris 2™ and Capyllaris 3™), Shanghai Kehua Bio-Engineering (KHB), Euroimmun™, Guangzhou Wondfo Biotech Co., Ltd (Wondfo), Aesku™, Werfen, Copan™, Becton Dickenson™, Pointe Scientific, Dexcom ™ (G6, G7, Dexcom One, Stelo), Meril Life (MeriScreen™) and DiaSorin Liaison.
The diagnostics industry is focused on the testing of biological specimens in a laboratory or at the point-of-care and is highly competitive and rapidly changing. As new products enter the market, our products may become obsolete or a competitor’s products may be more effective or more effectively marketed and sold than ours. If we fail to maintain and enhance our competitive position, our customers may decide to use products developed by competitors which could result in a loss of revenues and adversely affect our results of operations, cash flow and business.
We may in certain instances also face competition from products that are sold at a lower price. Where this occurs, customers may choose to buy lower cost products from third parties or we may be forced to sell our products at a lower price, both of which could result in a loss of revenues or a lower gross margin contribution from the sale of our products. We may also be required to increase our marketing efforts in order to compete effectively, which would increase our costs.
Our tests compete with products made by our competitors. Multiple competitors are making investments in competing technologies and products, and a number of our competitors have significantly greater financial, technical, research and other resources. Some competitors offer broader product lines and may have greater market presence or name recognition than we have. If we receive FDA or other regulatory clearance for new products, and in order to achieve market acceptance, we and/or our distributors will likely be required to undertake substantial marketing efforts and spend significant funds to inform potential customers and the public of the existence and perceived benefits of the products. Our marketing efforts for these products may not be successful. As such, there can be no assurance that these products will obtain significant market acceptance and fill the market needs that are perceived to exist on a timely basis, or at all.
Our ability to sell products could be adversely affected by reductions in government funding and sector consolidation.
We are continuously monitoring the potential impact of the U.S. President’s Executive Order on Reevaluating and Realigning United States Foreign Aid, and the resulting suspensions or terminations of funding to HIV testing programs that utilize the Company’s two rapid HIV tests. On January 20, 2025, the U.S. government paused, subject to certain exemptions, all new funding obligations and sub-obligations of funding of foreign assistance programs, and subsequently completed a 90-day review of such foreign assistance programs. Although the U.S. government introduced a temporary waiver of the aforementioned funding pause for certain assistance, which the U.S. government later confirmed applied to funding for HIV testing under the President's Emergency Plan for AIDS Relief (PEPFAR), that waiver is temporary, and there can be no assurance that U.S. government funding for HIV programs that utilize the Company’s rapid HIV tests will continue. Since the Executive Order, the Company has seen disruptions to ordering patterns and demand for our rapid HIV tests, and it remains unclear at this time what impact these changes will have on the timing and quantity of rapid HIV tests sold by the Company, and the receipt of funds for the sale of such tests. Following the review period, certain foreign assistance programs have experienced pauses, reductions, or cancellations, and procurement and implementation timelines have been subject to change. In some cases, procurement for HIV rapid tests has continued under program-specific exemptions or alternative funding; however, there can be no assurance that such procurement will continue or that any reductions will be offset. We continue to monitor these developments. These U.S. policy shifts, appropriations changes, and procurement actions could reduce or delay funding available to our customers and, in turn, materially and adversely affect demand for our products, our sales, cash flows, and results of operations.
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Changes in funding for the U.S. Food and Drug Administration (the “FDA”) and other government agencies, or disruptions to the staffing and operations of the FDA and other government agencies could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
The ability of the FDA to review and/or approve new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions. Average review times at the FDA have fluctuated in recent years as a result. The current U.S. Administration has issued executive orders seeking to greatly reduce the size of the federal workforce, including through layoffs and severance packages offered to employees of federal agencies within the executive branch and independent agencies, including the FDA. Any such reduction in personnel may result in longer review times by the FDA and other agencies.
Disruptions at the FDA and other federal agencies, including substantial leadership departures, personnel cuts, and policy changes, may also slow the time necessary for new products to be reviewed and/or approved by necessary government agencies, which would harm our business. Changes and cuts in FDA staffing also could result in delays in the FDA’s responsiveness or in its ability to review IND submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at all. There is also substantial uncertainty as to how regulatory reform measures being implemented by the current U.S. administration, and other political developments, such as government shutdowns or work stoppages, would impact U.S. regulatory agencies on which our operations rely. For example, in March 2025, the Department of Health and Human Services announced a broad-scale restructuring effort designed to significantly reduce FDA headcount. In April 2025, FDA employees began to receive reduction in force notices.
In addition, the U.S. government has shut down several times, including in October 2025, and certain regulatory agencies, such as the FDA, have previously had to furlough critical employees and stop critical activities. A prolonged government shutdown or significant leadership, personnel, and/or policy changes, or other substantial modification in agency activities (including due to global health concerns or geopolitical factors) could significantly impact the ability of the FDA or other regulatory authorities to conduct their regular inspections, reviews, or other regulatory activities, including the timely review and processing of our regulatory submissions, which could have a material adverse effect on our business. Further, in our operations as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
Government funding of other agencies on which our operations may rely, including those that fund research and development activities and clinical trials, or which purchase our products, is subject to the political process, which is inherently fluid and unpredictable and disruptions to such agencies’ funding or changes to their budgets, may negatively impact our operations and sales. For example, in 2025, the U.S. administration temporarily paused, and then further reduced funding for, HIV testing programs that utilize our rapid HIV tests, causing disruptions to ordering patterns and demand for our rapid HIV tests, with consequent disruptions to our payments and cashflow. Future shutdowns or other disruptions could also affect other government agencies such as the SEC, which may also impact our business by delaying review of our public filings, to the extent such review is necessary, and our ability to access the public markets.
There continues to be substantial uncertainty as to whether and how the current U.S. administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies that fund the purchase of our products, or with jurisdiction over the regulatory approval of our products. Additionally, the current U.S. administration could issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or create a more challenging or costly environment to pursue the development of new products.
Our sales of point-of-care HIV tests in Africa are dependent on our inclusion in the applicable country’s HIV testing algorithms and our exclusion from one or more of those HIV testing algorithms, or a delay in the implementation of a HIV testing algorithm, could adversely affect our business and financial results. Those HIV testing algorithms can be subject to legal challenges from market participants, competitors or other stakeholders which can result in delays in the algorithm being implemented or the algorithm being revised to exclude the incumbent provider.
Most countries in Africa have an established national HIV testing algorithm. The algorithm determines which provider’s HIV point-of-care test will be used. The World Health Organisation has indicated that national HIV algorithms should contain a HIV screening test (A1) and two HIV confirmatory tests (A2 and A3). Our inclusion on a national HIV testing algorithm determines whether we will be able to sell HIV tests in that country. HIV testing algorithms are not updated annually and typically run for between five and seven years. Our Uni-gold HIV confirmatory test is included on many HIV testing algorithms throughout Africa and our newly launched HIV screening test, TrinScreen, succeeded in being added to Kenya’s algorithm in 2023. In Kenya, the update to the HIV testing algorithm was challenged through the courts by a competitor and that legal challenge caused a delay in purchase orders being placed by the Kenyan health authorities under their revised algorithm. In 2024, another competitor began a court challenge in Kenya to the adopted HIV testing algorithm. Although we are not party to this court case, and the judge did not suspend procurement while the case is ongoing, it could have an adverse impact for us if the competitor succeeds in revising the current HIV testing algorithm. We understand that there were a number of hearings regarding this case during 2025 and we continue to monitor the ongoing court case. Legal challenges to the HIV testing algorithms from competitors, or other stakeholders, in any country in which we sell HIV tests could adversely affect our business and financial results.
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Global trade issues and changes in and uncertainties with respect to trade policies and export regulations, including import and export license requirements, trade sanctions, tariffs and international trade disputes, have already impacted and could further impact our business and operations, reduce the competitiveness of our products and otherwise have a material adverse effect on our business, financial condition, results of operations and growth prospects.
There is inherent risk, based on the complex relationships among the United States and the other countries in which we conduct our business, that political, diplomatic, and national security factors can lead to global trade restrictions and changes in trade policies and export regulations that may adversely affect our business and operations. The United States and other countries have imposed and may continue to impose new trade restrictions and export regulations, have levied tariffs and taxes on certain goods, and could continue to significantly increase tariffs on a broad array of goods, including medical devices and related components.
In recent years, the United States has imposed, and may continue to impose, tariffs, including so‑called reciprocal tariffs, on a range of imported goods. Certain tariff actions have been subject to legal challenge, modification or reversal, while new or expanded tariffs have also been announced or implemented, creating ongoing uncertainty and volatility in U.S. trade policy. In February 2026, the United States Supreme Court ruled that the use of the International Emergency Economic Powers Act (IEEPA) to impose tariffs was not permitted, invalidating a significant portion of tariffs that had been in effect since April 2025. While the ruling struck down the IEEPA-based tariffs, it does not address the Administration’s ability to impose tariffs using other mechanisms. The Administration responded by invoking alternative mechanisms to impose a 10% global tariff that was subsequently raised to 15%. The Administration also initiated trade investigations that could result in additional future tariffs. In response, other governments have imposed, and may continue to impose, retaliatory or reciprocal tariffs, trade restrictions or other trade barriers. Although we are an Irish company headquartered in Bray, Ireland, we derive a significant portion of our revenues from sales of our products in the United States, and we conduct business globally, including in markets that have been affected by reciprocal trade measures. Our operations and third‑party suppliers span numerous countries outside the United States, and we sell instruments and other products into jurisdictions, such as China, where reciprocal tariffs and trade restrictions have adversely impacted demand and pricing. As a result, current or future U.S. tariffs, retaliatory or reciprocal measures, or further changes in trade policy could adversely affect our supply chain, increase the cost of components and raw materials, reduce sales of our products in certain international markets, and negatively impact our results of operations.
The enactment of tariffs and the uncertainty surrounding their scope, duration, and applicable rates, as well as ongoing changes in U.S. and foreign government trade policies, including potential modifications to existing trade agreements and the continued threats of sanctions and other trade restrictions and barriers, have had and may continue to have a generally disruptive impact on the global economy and, therefore, negatively impact revenues from sales of our products. Given the volatility and uncertainty regarding the scope and duration of such tariffs and other aspects of U.S. and foreign government trade policies, the ultimate impact on our operations and financial results is uncertain and could be significant. In any event, further trade restrictions and export regulations, or new or increased tariffs, including further retaliatory measures, could increase our supply chain complexity and our manufacturing costs, decrease our margins, reduce the competitiveness of our products, or restrict our ability to sell our products, provide services or purchase necessary equipment and supplies. Any of these factors could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
Failure to achieve our financial and strategic objectives could have a material adverse impact on our business prospects. We may not succeed in our efforts to implement a comprehensive transformation plan to improve the financial performance of our existing business and realign our continuing business.
As a result of any number of risk factors identified herein, no assurance can be given that we will be successful in implementing our financial and strategic objectives. In addition, the funds for research, clinical development and other projects have in the past come partly from our business operations. If our business slows and we have less money available to fund research and development and clinical programs, we will have to decide at that time which programs to cut, and by how much. Similarly, if adequate financial, personnel, equipment or other resources are not available, we may be required to delay or scale back our business. Our operations will be adversely affected if our total revenue and gross profits do not correspondingly increase or if our technology, product, clinical and market development efforts are unsuccessful or delayed. Furthermore, our failure to successfully introduce new or enhanced products and develop new markets could have a material adverse effect on our business and prospects.
We initially announced the adoption of a transformation plan to improve the financial performance of our existing business in April 2024 and we continue to pursue and execute a strategic realignment of our continuing business. The plan has several key components, including:
Reducing complexity and cost by consolidating our main manufacturing operations into a considerably smaller number of sites and also moving to an outsourced model for a significant amount of our less complex manufacturing activities;
Reducing the cost of goods of many of our products by changing suppliers and negotiating new deals with existing suppliers;
Continued market acceptance of our new TrinScreen™ HIV rapid point-of-care test;
Simplifying our internal operations and optimizing and outsourcing some of our business support function locations; and
Realigning our existing business portfolio to support our planned growth in the CGM space.
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Although we have implemented, and are further advanced in implementing, key elements of this plan, including consolidating manufacturing, moving certain manufacturing activities offshore to improve operating margins, and centralizing significant business support functions in a lower‑cost shared services environment, there remains execution risk. We may encounter delays, cost overruns, operational disruption, or lower‑than‑expected efficiency gains, and we cannot assure you that these initiatives will ultimately deliver the anticipated financial benefits or that we will achieve our long‑term profitability goals. A failure to achieve these goals will have a material adverse effect on our results of operations and financial condition.
Consolidation of our customers or the formation of group purchasing organisations could result in increased pricing pressure and other changing conditions that could adversely affect our operating results.
The health care industry has undergone significant consolidation resulting in increased purchasing leverage for customers and consequently increased pricing pressures on our business. Additionally, some of our customers have become affiliated with group purchasing organisations. Group purchasing organisations typically offer members price discounts on laboratory supplies and equipment if they purchase a bundled group of one supplier’s products, which results in a reduction in the number of manufacturers selected to supply products to the group purchasing organization and increases the group purchasing organization’s ability to influence its members’ buying decisions. Further consolidation among customers or their continued affiliation with group purchasing organizations may result in significant pricing pressures and correspondingly reduce the gross margins of our business or may cause our customers to reduce their purchases of our products, thereby adversely affecting our business, prospects, operating results or financial condition.
The trend towards managed care, together with healthcare reform of the delivery system in the U.S. and efforts to reform in Europe, has resulted in increased pressure on healthcare providers and other participants in the healthcare industry to reduce selling prices. Consolidation among healthcare providers and consolidation among other participants in the healthcare industry has resulted in fewer, more powerful groups, whose purchasing power gives them cost containment leverage. In particular, there has been a consolidation of laboratories. These industry trends and competitive forces place constraints on the levels of overall pricing, and thus could have a material adverse effect on our gross margins for products we sell in clinical diagnostic markets.
The diagnostics industry is in transition, with a number of changes that affect the market for diagnostic test products. For example, major consolidation among reference laboratories through mergers and acquisitions and the formation of multi-hospital alliances in the past several years has reduced the number of institutional customers for diagnostic test products. There can be no assurance that we will be able to enter into and/or sustain contractual or other marketing or distribution arrangements on a satisfactory commercial basis with these institutional customers. Further, this consolidation trend may result in the surviving companies having greater financial resources and technological capabilities, thereby intensifying competition in the industry, which could have a material adverse effect on our business.
We are dependent on third-party suppliers for certain critical components and the primary raw materials required for our test kits.
The primary raw materials required for Trinity Biotech’s test kits consist of antibodies, antigens or other reagents, glass fibre and packaging materials which are acquired from third parties. Our biosensor business and our HbA1c business, both rely on a supply of raw materials to manufacture polymers, electronics and specialist engineered components. If our third-party suppliers are unable or unwilling to supply or manufacture a required component or product or if they make changes to a component, product or manufacturing process or do not supply materials meeting our specifications, we may need to find another source and/or manufacturer. This could require that we perform additional development work.
Some of our products, which we acquire from third parties, are highly technical and are required to meet exacting specifications, and any quality control problems that we experience with respect to the products supplied by third-party vendors could adversely and materially affect our reputation, our attempts to complete our clinical trials or commercialization of our products and adversely and materially affect our business, operating results and prospects. We may also need to obtain FDA or other regulatory authorisations for the use of an alternative component or for certain changes to our products or manufacturing process. We may also have difficulty obtaining similar components from other suppliers that are acceptable to the FDA or other regulatory authorities and the failure of our suppliers to comply with strictly enforced regulatory requirements could expose us to regulatory action including, warning letters, product recalls, termination of distribution, product seizures, or civil penalties. Completing that development and obtaining such authorisations could require significant time and expense and we may not obtain such authorisations on a timely basis, or at all. The availability of critical components and products from other third parties could also reduce our control over pricing, quality and timely delivery. These events could either disrupt our ability to manufacture and sell certain of our products into one or more markets or completely prevent us from doing so and could increase our costs. Any such event could have a material adverse effect on our results of operations, cash flow and business. Furthermore, since some of these suppliers are located outside of the United States, we are subject to export laws and import and customs regulations in many jurisdictions, which complicate and could delay shipments of components to us. In recent years, including in 2022, we experienced disruptions to our international supply chain that adversely affected certain aspects of our operations. More recently, geopolitical instability and military conflicts in certain regions have contributed to ongoing logistical challenges, including increased transportation costs, extended delivery times and reduced shipping capacity. There can be no assurance that such disruptions will not continue or recur in the future, which could create significant challenges in fulfilling customer orders and may adversely affect our operating results.
The ongoing uncertainty regarding the upheaval to global trade from significant international tariff changes represents a significant and growing risk to our business and could materially increase our cost of goods sold, disrupt supply chains, and delay production or fulfilment schedules. Although typically we do not plan to be dependent upon any one source for these critical components or raw materials, alternative sources of such raw materials or components with the characteristics and quality desired by us may not be available or commercially viable. Such unavailability could affect the quality of our products and our ability to meet orders for specific products.
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If our products cause or contribute to a death or serious injury, or malfunction in certain ways, we are subject to medical device reporting requirements, which may result in voluntary corrective actions or regulatory enforcement.
We are required to comply with the U.S. Food and Drug Administration (“FDA”) Medical Device Reporting (“MDR”) regulations, as well as comparable vigilance and reporting obligations in other jurisdictions, such as those enforced by the Health Products Regulatory Authority (“HPRA”) in Ireland. Under the FDA’s MDR regulations, we must report any event in which one of our products may have caused or contributed to a death or serious injury, or in which a malfunction would likely cause or contribute to a death or serious injury if it were to recur.
In the European Union, manufacturers of in vitro diagnostic medical devices are subject to the In Vitro Diagnostic Medical Device Regulation (Regulation (EU) 2017/746) (“IVDR”). Several categories of devices require assessment and certification by an independent Notified Body before the manufacturer may affix a CE mark. Under the IVDR, we must notify the competent authority of any serious incidents or potential serious incidents involving our devices within defined timelines.
If a serious incident or malfunction were to occur, the relevant competent authority may initiate an investigation and may require additional inspection or assessment, either directly or through our Notified Body.
We have submitted MDRs in the past, and we anticipate that we may experience reportable events in the future. Any adverse event involving our products could result in voluntary corrective actions, such as field safety notices or product corrections, or regulatory enforcement actions, including inspections, safety communications, mandatory recalls, or other sanctions.
Any corrective action - whether voluntary or required - as well as any related litigation, could divert management’s attention, require significant financial and operational resources, damage our reputation, and negatively affect our business, results of operations, and financial condition.
We may be subject to liability resulting from our products or services.
We may be subject to claims for personal injuries or other damages if any of our products, services, or any product which is made with the use or incorporation of any of our technologies, causes injury of any type or is found otherwise unsuitable during product testing, manufacturing, marketing, sale or usage. There is no assurance that we would be successful in defending any product liability lawsuits brought against us. Regardless of merit or eventual outcome, product liability claims could result in:
Decreased demand for our products;
Lost revenues;
Damage to our image or reputation;
Costs related to litigation; and
Diversion of management time and attention;
We have global product liability insurance in place for our manufacturing subsidiaries up to a maximum of €6,500,000 (US$7,647,059) (December 31, 2025) for any one accident, limited to a maximum of €6,500,000 (US$7,647,059) (December 31, 2025) in any one-year period of insurance and is subject to a deductible. We also have professional indemnity insurance for the laboratory services business up to a maximum of US$3,000,000 for each claim and a US$4,000,000 aggregate limit. There can be no assurance that our product liability insurance is sufficient to protect us against liability that could have a material adverse effect on our business. In addition, although we believe that we will be able to continue to obtain adequate coverage in the future, there is no assurance that we will be able to do so at acceptable costs.
Our products may be subject to product recalls that could harm our reputation, business and financial results.
Manufacturers may voluntarily initiate market withdrawals, corrections, safety alerts, or reportable product recalls to address material deficiencies, improve device performance, or for other reasons. In addition, the FDA and comparable foreign regulatory authorities may require involuntary recalls when they identify material deficiencies or defects in a device’s design, manufacturing, or labelling, or when a product poses an unacceptable risk to health. The FDA may mandate a recall upon determining that there is a reasonable probability that a device would cause serious adverse health consequences or death.
A government mandated or voluntary recall could occur due to component failures, manufacturing errors, design or labelling defects, or other deficiencies. Any recall of our products could divert managerial and financial resources and adversely affect our business, financial condition, and results of operations. Certain classifications of recalls must be reported to the FDA within ten working days of initiation.
We are required to maintain records of post-market actions, even when we determine that such actions are not reportable to the FDA. If we conclude that certain actions are not reportable, the FDA may disagree and require us to classify and report those actions as recalls. Any future recall announcement could harm our reputation with customers and negatively impact our sales.
The FDA may also take enforcement action if we fail to report recalls or other corrective actions, or if we fail to do so in a timely manner. Depending on the corrective actions needed to address a product deficiency, the FDA may require - or we may determine - that new clearances or approvals are necessary before we may market or distribute the corrected device. Seeking such clearances or approvals may delay our ability to replace recalled devices and resume commercial distribution in a timely manner.
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The large amount of intangible assets and goodwill recorded on our balance sheet may lead to significant impairment charges in the future.
We regularly review our long-lived assets, including identifiable intangible assets and goodwill, for impairment. Goodwill and acquired indefinite life intangible assets are subject to impairment review on a periodic basis and whenever potential impairment indicators are present. Other long-lived assets are reviewed when there is an indication that an impairment may have occurred. The amount of goodwill and identifiable intangible assets on our consolidated balance sheet as of December 31, 2025, was US$57 million (December 31, 2024: US$51 million) (December 31, 2023: US$16 million). In the year ended December 31, 2025, we recorded total impairment charges on intangible assets of US$2.1 million (Year 2024: US$1.6 million) (Year 2023: US$5.8 million) as a result of our periodic impairment review. We may record further significant impairment charges in the future if there are changes in market conditions, a significant reduction in share price or other changes in the future outlook. In addition, we may from time to time sell assets that we determine are not critical to our strategy or execution. Future events or decisions may lead to asset impairments and/or related charges. Certain impairments may result from a change in our strategic goals, business direction or other factors relating to the overall business environment. Any significant impairment charges could have a material adverse effect on our results of operations.
Global economic conditions may have a material adverse impact on our results.
Uncertainty in global economic conditions may continue for the foreseeable future and intensify. International conflicts and related geopolitical tensions, including the Israel–Hamas war, the Russia–Ukraine war, and the escalating conflicts in the Middle East involving the United States, Israel, Iran, and regional armed groups have destabilised markets, increased volatility and created uncertainty, particularly in energy supply and energy prices. This uncertainty poses a risk to the overall economy that could impact demand for our products, as well as our ability to manage normal commercial relationships with our customers, suppliers and creditors, including financial institutions. Volatile economic conditions have adversely affected and could continue to adversely affect our financial performance and condition or those of our customers and suppliers. These circumstances could adversely affect our access to liquidity needed to conduct or expand our business or conduct future acquisitions, refinance existing debts, or make other discretionary investments. Many of our customers rely on public funding provided by federal, state and local governments, and this funding may be reduced or deferred as a result of economic conditions.
The ongoing uncertainty regarding the upheaval to global trade from significant international tariff changes represents a significant and growing risk to our business and could materially increase our cost of goods sold, disrupt supply chains, and delay production or fulfilment schedules.
If global economic conditions deteriorate significantly, our business could be negatively impacted, including such areas as reduced demand for our products from a slow-down in the general economy, supplier or customer disruptions resulting from tighter credit markets and/or temporary interruptions in our ability to conduct day-to-day transactions through our financial intermediaries involving the payment to or collection of funds from our customers, vendors and suppliers. These circumstances may adversely impact our customers and suppliers, which, in turn, could adversely affect their ability to purchase our products or supply us with necessary equipment, raw materials or components. Even with the improvement of economic conditions, it may take time for our customers and suppliers to establish new budgets and return to normal purchasing and shipping patterns. We cannot predict the reoccurrence of any economic slowdown or the strength or sustainability of the economic recovery.
Significant interruptions in production at our principal manufacturing facilities and/or third-party manufacturing facilities would adversely affect our business and operating results.
Products manufactured at our facilities in Bray, Ireland, Jamestown and Buffalo, New York and Kansas City, Missouri alongside our contract manufacturing facility in India accounted for the majority of our revenues during the fiscal year ended December 31, 2025. Our global supply of these products and services is dependent on the uninterrupted and efficient operation of these facilities. In addition, we currently rely on a small number of additional third-party manufacturers to produce certain of our diagnostic products and product components. If we do not negotiate long-term contracts, our suppliers will likely not be required to provide us with any guaranteed minimum production levels. As a result, we cannot assure you that we will be able to obtain sufficient quantities of product in the future. In addition, our reliance on third-party suppliers involves a number of risks, including, among other things:
contract manufacturers or suppliers may fail to comply with regulatory requirements or make errors in manufacturing that could negatively affect the efficacy or safety of our products or cause delays in shipments of our products;
we or our contract manufacturers and suppliers may not be able to respond to unanticipated changes in customer orders, and if orders do not match forecasts, we or our suppliers may have excess or inadequate inventory of materials and components;
we or our contract manufacturers and suppliers may be subject to price fluctuations due to a lack of long-term supply arrangements for key components;
we or our contract manufacturers and suppliers may lose access to critical services and components, resulting in an interruption in the manufacture, assembly and shipment of our systems;
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we may experience delays in delivery by our contract manufacturers and suppliers due to changes in demand from us or their other customers;
fluctuations in demand for products that our contract manufacturers and suppliers manufacture for others may affect their ability or willingness to deliver components to us in a timely manner;
our suppliers or those of our contract manufacturer may wish to discontinue supplying components or services to us for risk management reasons;
we may not be able to find new or alternative components or reconfigure our system and manufacturing processes in a timely manner if the necessary components become unavailable; and
our contract manufacturers and suppliers may encounter financial hardships unrelated to our demand, which could inhibit their ability to fulfil our orders and meet our requirements.
The operations of our facilities or these third-party manufacturing facilities could be adversely affected by fire, power failures, natural or other disasters, such as earthquakes, floods, pandemics, or terrorist threats. Although we carry insurance to protect against certain business interruptions at our facilities, some pieces of manufacturing equipment are difficult to replace and could require substantial replacement lead-time. There can be no assurance that such coverage will be adequate or that such coverage will continue to remain available on acceptable terms, if at all.
If any of these risks materialize, it could significantly increase our costs and impact our ability to meet demand for our products and/or services. If we are unable to satisfy commercial demand for our products in a timely manner, our ability to generate revenue would be impaired, market acceptance of our products could be adversely affected, and customers may instead purchase or use our competitors’ products. In addition, we could be forced to secure new or alternative contract manufacturers or suppliers. Securing a replacement contract manufacturer or supplier could be difficult. The introduction of new or alternative manufacturers or suppliers also may require design changes to our products that are subject to FDA and/or other regulatory clearances or approvals.
We may also be required to assess the new manufacturer’s compliance with all applicable regulations and guidelines, which could further impede our ability to manufacture our products in a timely manner. As a result, we could incur increased production costs, experience delays in deliveries of our products, suffer damage to our reputation, and experience an adverse effect on our business and financial results. Any significant interruption in our or third-party manufacturing capabilities could materially and adversely affect our operating results.
Our inability to manufacture products in accordance with applicable specifications, performance standards or quality requirements could adversely affect our business.
The materials and processes used to manufacture our products must meet detailed specifications, performance standards, and quality requirements to ensure that our products perform in accordance with their label claims, our customers’ expectations, and applicable regulatory requirements.
Accordingly, our products and the materials used in their manufacture or assembly undergo routine inspections and quality testing. Factors such as defective materials or processes, mechanical failures, human error, environmental conditions, or changes in materials or production methods by our vendors could cause our products or the materials used to produce or assemble them to fail inspections and testing or otherwise not perform as intended or not perform in accordance with our label claims or the expectations of our customers.
Any failure or delay in meeting applicable specifications, performance standards, quality requirements, or customer expectations could adversely affect our ability to manufacture and sell our products or comply with regulatory requirements. These events could, in turn, negatively impact our revenues, cashflows and results of operations.
Our revenues are highly dependent on a network of distributors worldwide.
We currently distribute our product portfolio through distributors in approximately 100 countries worldwide. Our continuing economic success and financial security is dependent on our ability to secure effective channels of distribution on favourable trading terms with suitable distributors.
The loss or termination of our relationship with these key distributors could significantly disrupt our existing business unless suitable alternatives were quickly found or lost sales to one distributor are absorbed by another distributor. Finding a suitable alternative to a lost or terminated distributor may pose challenges in our industry’s competitive environment, and another suitable distributor may not be found on satisfactory terms, if at all. For instance, some distributors already have exclusive arrangements with our competitors, and others do not have the same level of penetration into our target markets as our existing distributors. If total revenue from these or any of our other significant distributors were to decrease in any material amount in the future or we are not successful in timely transitioning business to new distributors, our business, operating results and financial condition could be materially and adversely affected.
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Our success depends on our ability to service and support our products directly or in collaboration with our strategic partners.
To the extent that we or our strategic partners fail to maintain a high-quality level of service and support for diagnostic products, there is a risk that the perceived quality of our products will be diminished in the marketplace. Likewise, we may fail to provide the level, quantity or quality of service expected by the marketplace. This could result in slower adoption rates and lower than anticipated utilisation of our products which could have a material adverse effect on our business, financial condition and results of operations.
We are highly dependent on our senior management team and other key employees, and the loss of one or more of these employees or the inability to attract and retain qualified personnel as necessary could adversely affect our operations.
Our success is dependent to a large extent upon the contributions of our senior leadership and key employees. We have recently experienced several transitions in senior leadership. In April 2025, Louise Tallon was replaced by Susan O’Connor as Interim CFO. In December 2025, Susan O’Connor was replaced by Paul Murphy, now serving as Interim CFO. Matthew Wictome replaced Ian Wells as Vice President of Quality and Regulatory Affairs in April 2025. Colm Molloy left the Company as Group Director of Human Resources and Culture in December 2025.
The effectiveness of our senior leadership team generally, and any further transition as a result of these changes, could have a significant impact on our results of operations. Management transition is often difficult and inherently causes some loss of institutional knowledge, which could negatively affect our results of operations and financial condition. Our ability to execute our business strategies may be adversely affected by the uncertainty associated with these transitions. We may not be able to attract or retain a sufficient number of qualified employees in the future due to the intense competition for qualified personnel among medical products and other life science businesses.
If we are not able to attract and retain the necessary personnel to accomplish our business objectives, we may experience constraints that will adversely affect our ability to effectively manufacture, sell and market our products, to meet the demands of our strategic partners in a timely fashion, or to support research, development and clinical programs. Although we believe we will be successful in attracting and retaining qualified personnel, competition for experienced scientists and other personnel from numerous companies and academic and other research institutions may limit our ability to do so on acceptable terms.
Cybersecurity risks, including cyberattacks or data breaches, could disrupt our operations, compromise sensitive data, and adversely affect our business.
We rely extensively on information technology systems and networks to support our global operations, including product manufacturing, distribution, research and development, clinical activities, customer service, and financial reporting. Any significant disruption, failure, or unauthorised access to these systems could impair our ability to operate effectively.
Like many companies, we face an increasing number of cybersecurity threats, including system breaches, ransomware, malware, phishing attacks, and other forms of malicious activity. Such incidents may result in operational downtime, loss or corruption of data, unauthorised disclosure of confidential or personal information, reputational harm, and financial loss.
Although we maintain appropriate technical and organizational security measures designed to protect our systems and data, no cybersecurity framework can prevent all threats. Our systems may still be vulnerable to attack due to the sophistication of threat actors, human error, equipment failure, third‑party vulnerabilities, or other unforeseen events.
We conduct cybersecurity assessments of our systems and technology, including penetration testing, vulnerability scanning, and risk‑based remediation. These practices are designed to identify and address security vulnerabilities in our environment. As regulatory expectations for cybersecurity continue to evolve, we may need to make additional investments or implement further enhancements to maintain compliance and support the security of our systems and connected technologies.
We have experienced cyberattacks in the past; however, none have had a material impact on our operations to date. The age and configuration of our IT infrastructure varies across locations, and business continuity and disaster recovery capabilities may be less robust in certain sites, which could affect our response or recovery in the event of an incident.
We are also subject to a complex and evolving regulatory landscape in data privacy and cybersecurity. Compliance with privacy and data protection laws, such as the EU’s General Data Protection Regulation (GDPR), U.S. state-level privacy laws, and similar frameworks in other jurisdictions, may result in significant costs and operational changes. In particular, Section 3305 of the Food and Drug Omnibus Reform Act of 2022 (FDORA) imposes specific cybersecurity obligations on manufacturers of certain medical devices. This includes maintaining processes for monitoring and remediating vulnerabilities, providing a software bill of materials, and ensuring continued security of the device and its related systems. A failure to comply with these requirements may constitute a prohibited act. Additionally, as a manufacturer of medical devices, we will also likely be subject to the EU’s new cybersecurity legislative package, once fully transposed into Irish law. This would likely require us to implement a range of cybersecurity requirements including in respect of incident handling, business continuity, supply chain security, and governance.
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We have conducted cybersecurity assessments for relevant products in accordance with FDA, AAMI, and ANSI standards applicable at the time of approval. However, as the regulatory landscape continues to evolve, we may be required to make additional investments to maintain compliance and address emerging cybersecurity expectations for connected health technologies.
A significant cybersecurity incident could distract management or key personnel from core business operations and negatively affect our financial condition, results of operations, and business strategy.
Our sales and operations are subject to the risks of fluctuations in currency exchange rates.
A substantial portion of our operations are based in Ireland, and Europe is one of our main sales territories. As a result, changes in the exchange rate between the U.S. Dollar and the Euro can have significant effects on our results of operations. In addition, in markets where we invoice in U.S. Dollars but where the local currency has weakened, we have been required to reduce our pricing in order to preserve our competitiveness. We have an exposure to the Canadian Dollar through our Canadian operations and to the Brazilian Real through our Brazilian subsidiary. We also have revenues and costs denominated in British Sterling.
The ongoing geopolitical uncertainty, inflation and central bank actions may lead to greater volatility in currency exchange rates globally. In the future, we may enter into hedging instruments to manage our currency exchange rate risk. However, our attempts to hedge against these risks may not be successful. If we are unable to successfully hedge against unfavourable foreign currency exchange rate movements, our consolidated financial results may be adversely impacted.
Tax matters, including disagreements with taxing authorities, the changes in corporate tax rates and imposition of new taxes could impact our results of operations and financial condition.
We are subject to regular reviews, examinations, and audits by tax authorities in a number of jurisdictions across the world with respect to our taxes. Although we believe our tax estimates are reasonable, if a taxing authority disagrees with the positions we have taken, we could face additional tax liability, including interest and penalties. There can be no assurance that payment of such additional amounts upon final adjudication of any disputes will not have a material impact on our results of operations and financial position.
A significant portion of our business is located in the U.S. and is subject to income and other taxes in the U.S. and our operations, plans and results are affected by tax and other initiatives. Changes to the US tax code could have a significant impact on our profitability. Changes to the tax code could also affect our valuation of deferred tax assets and liabilities. Any such change in valuation would have a material impact on our income tax expense and deferred tax balances.
Public health emergencies, epidemics or pandemics, such as the emergence and spread of pandemics, such as Covid-19, have the potential to significantly impact our operations through a decrease in demand for our products, interruption to business and a reduction in staff availability.
The Covid‑19 pandemic had a material impact on the healthcare industry and specifically the medical diagnostics sector in which we operate. The reduced but continuing uncertainty around global pandemics could have an adverse effect on our operating results, cash flows, financial condition and/or prospects.
The global spread of Covid‑19 and the public healthcare measures implemented by governments, such as quarantines and the temporary closure of businesses led and could again in the future lead to fewer patients presenting themselves for medical check-ups resulting in a fall in demand for certain of our products which may or may not be offset by increased demand within our Covid-19 related portfolio of products. Furthermore, funding allocated to combatting Covid-19 or other pandemics, may result in a reduction or a postponement in the funding available for other diseases, conditions and disorders that our products are used to diagnose.
We operate in a labour intensive industry where employees’, contractors’ and customers’ activities can be adversely impacted by the availability of people to produce, manufacture or install our products. Covid-19 lead to the temporary closure of our manufacturing sites and associated furloughing of some staff. Furthermore, Covid-19 reduced our ability to visit customers and suppliers and required some of our staff to work from home in line with public health measures. Any significant loss of employee resources for a sustained period of time due to lockdown restrictions, self‑isolation or sickness as a result of a public health emergency could impact our ability to produce, manufacture and deliver goods. Similarly, our customer facing activities could be adversely impacted by similar employee availability issues.
Increasing scrutiny and changing expectations from investors, lenders, customers and other market participants with respect to our Environmental, Social and Governance, or ESG, policies may impose additional costs on us or expose us to additional risks.
Companies across many industries face scrutiny relating to their ESG policies. While some investors, lenders and other market participants continue to focus on ESG practices and have placed greater importance on the implications and social cost of their investment, policy approaches vary across jurisdictions. This evolving landscape could affect our access to capital if investors or lenders adjust allocations based on their assessment of our ESG practices. If we do not adapt to or comply with investor, lender or other industry shareholder expectations and standards, which are evolving, or if we are perceived to have not responded appropriately to ESG issues, regardless of whether there is a legal requirement to do so, we may suffer from reputational damage and the business, financial condition and the price of our company’s ADSs could be materially and adversely affected.
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Risks Related to Government Regulations
Clinical trials necessary to support future premarket submissions will be expensive and will require enrolment of suitable patients who may be difficult to identify and recruit. Delays or failures in our clinical trials will prevent us from commercializing any modified or new products and will adversely affect our business, operating results and prospects.
Initiating and completing clinical trials necessary to support approval of future products under development, is time consuming and expensive and the outcome uncertain. Moreover, the results of early clinical trials are not necessarily predictive of future results, and any product we advance into clinical trials may not have favorable results in later clinical trials.
Conducting successful clinical studies will require the enrolment of patients who may be difficult to identify and recruit. Patient enrolment in clinical trials and completion of patient participation and follow-up depends on many factors, including the size of the patient population, the nature of the trial protocol, and the availability of appropriate clinical trial investigators. Patients may not participate in our clinical trials if they choose to participate in contemporaneous clinical trials of competitive products.
Development of sufficient and appropriate clinical protocols to demonstrate safety and efficacy are required and we may not adequately develop such protocols to support clearance and approval. Further, the FDA and/or other regulatory authorities may require us to submit data on a greater number of patients than we originally anticipated and/or for a longer follow-up period or change the data collection requirements or data analysis applicable to our clinical trials. Any challenges to patient enrolment may cause an increase in costs and delays in the approval and attempted commercialization of our products or result in the failure of the clinical trial. In addition, despite considerable time and expense invested in our clinical trials, FDA and/or other regulatory authorities may not consider our data adequate to demonstrate safety and efficacy. Such increased costs and delays or failures could adversely affect our business, operating results and prospects.
Our facilities and our clinical investigational sites operate under procedures that govern the conduct and management of FDA-regulated clinical studies under 21 CFR Parts 50, 56 and 812, and Good Clinical Practices. Although the majority of our in-vitro diagnostic (“IVD”) clinical studies meet the definition of exempted investigations under 21 Part 812 and are exempt from the Investigational Device Exemption (“IDE”) regulations in 21 CFR Part 812, we are still required to meet the requirements of 21 CFR Parts 50 and 56 for informed consent and Institutional Review Board (“IRB”) approval. The FDA may conduct Bioresearch Monitoring (“BiMo”) inspections of us and/or our clinical sites to assess compliance with FDA regulations, our procedures, and the clinical protocol. If the FDA were to find that we or our clinical investigators are not operating in compliance with applicable regulations, we could be subject to the above FDA enforcement action as well as refusal to accept all or part of our data in support of a 510(k) or PMA and/or we may need to conduct additional studies.
In relation to World Health Organisation (WHO) qualification, our IVD clinical studies are required to meet all the requirements of the TSS-1: Human Immunodeficiency Virus (HIV) rapid diagnostic tests for professional use. If we are not operating in compliance with this regulation, we could be subject to WHO enforcement action. In addition, our IVD clinical studies are required to meet the requirements of:
WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (2013);
ICH Harmonised Guidelines - Integrated Addendum to ICH E6 (R2) Guideline for Good Clinical Practice (Nov 2016);
ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice; and
ISO 14155:2020: Clinical investigation of medical devices for human subjects – Good clinical practice.
If the third parties on whom we rely to conduct our pre-clinical studies and clinical trials and to assist in pre-clinical development do not perform as contractually required or expected, we may not be able to obtain regulatory approval or commercialize our products.
We may not have the ability to independently conduct our pre-clinical studies and clinical trials for our products and we may rely on third parties, such as contract research organizations, medical institutions, clinical investigators and contract laboratories to conduct such trials. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if these third parties need to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our pre-clinical or clinical protocols or regulatory requirements or for other reasons, our pre-clinical development activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize, our products on a timely basis, if at all, and our business, operating results and prospects may be adversely affected. Furthermore, our third-party clinical trial investigators may be delayed in conducting our clinical trials for reasons outside of their control.
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The results of our clinical trials may not support our product candidate claims.
Even if our clinical trials are completed as planned, we cannot be certain that their results will support our product candidate claims or that the FDA or other regulatory authorities will agree with our conclusions regarding them. The clinical trial process may fail to demonstrate that our product candidates are safe and effective for the proposed indicated uses, which could cause us to abandon a product candidate and may delay development of others. Any delay or termination of our clinical trials will delay the filing of our product submissions and, ultimately, our ability to commercialize our product candidates and generate revenues.
We may be subject to fines, penalties or injunctions if we are determined to be promoting the use of our products for unapproved or “off-label” uses.
Our promotional materials must comply with FDA requirements and other applicable laws and regulations. We believe that the specific uses for which our products are marketed fall within the scope of the indications for use that have been cleared or approved by the FDA or other relevant regulatory authorities. However, those authorities may disagree and require us to stop promoting our products for certain uses until we obtain the necessary clearance or approval. If the FDA or other regulatory authorities determine that our promotional materials promote an unapproved use, they may require us to revise our materials or may take regulatory or enforcement action, including issuing an untitled letter, a warning letter, or imposing injunctions, seizures, civil fines, or criminal penalties.
Other federal, state, or foreign enforcement authorities may also take action if they view our promotional activities as promoting unapproved uses, potentially resulting in significant fines or penalties under other statutory regimes, including laws prohibiting the submission of false claims for reimbursement. Any such actions could damage our reputation and impair the adoption of our products.
The FDA recently modified its policy of enforcement discretion with respect to our laboratory developed tests. We could incur substantial costs and delays associated with any future requirement to obtain premarket clearance or other regulatory approvals.
Historically, the FDA has generally exercised enforcement discretion and has not actively enforced most medical device regulatory requirements with respect to laboratory developed tests (“LDTs”), although reagents, instruments, software, and other components supplied by third parties for use in LDTs may be subject to FDA oversight. The FDA defines an LDT as an in vitro diagnostic (“IVD”) test that is intended for clinical use and designed, manufactured, and used within a single laboratory. In recent years, the FDA has also signaled that certain high risk or widely marketed LDTs may warrant increased regulatory oversight.
On September 29, 2023, the FDA proposed a rule clarifying that all IVDs are medical devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer is a clinical laboratory. The final rule, adopted on April 29, 2024, would have significantly expanded FDA oversight of LDTs. However, on March 31, 2025, the U.S. District Court for the Eastern District of Texas vacated the final rule, holding that the FDA exceeded its statutory authority. As a result, the rule will not take effect unless reversed on appeal, and laboratories are not currently required to obtain FDA clearance or approval to market their LDTs. If the decision is upheld, the FDA’s ability to regulate LDTs as medical devices may be substantially curtailed, and LDTs would continue to be regulated primarily under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”).
Despite the court’s ruling, the regulatory landscape for LDTs remains uncertain. The FDA may appeal the decision, pursue new rulemaking, or seek additional Congressional authority. Future legislative or regulatory changes could impose new premarket review requirements, quality system obligations, adverse event reporting requirements, or other compliance burdens on laboratories offering LDTs. Any such changes could require us to incur substantial costs, modify our operations, or delay the development, validation, and commercialization of our LDTs.
Congress has periodically considered legislation that would create a unified regulatory framework for all in vitro clinical tests, including those currently regulated solely as LDTs. If enacted, such legislation could impose new premarket review, quality system, adverse event reporting, and other operational requirements on laboratories, which could increase our regulatory burden and delay the commercialization of new tests.
Even in the absence of a binding FDA framework, individual states, commercial payors, and accrediting bodies may impose additional requirements on LDT providers. These parallel obligations could create inconsistent or overlapping compliance requirements, increase operational complexity, and raise the cost of maintaining and offering our LDTs.
Ongoing compliance obligations - including CLIA requirements, state licensure requirements, and any future FDA or legislative requirements - increase the cost and complexity of conducting our business. Failure to comply with applicable regulatory requirements may subject us to additional scrutiny, enforcement actions, or penalties, any of which could adversely affect our business, financial condition, or results of operations.
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If we fail to maintain existing regulatory approval and clearances, or are unable to obtain, or experience significant delays in obtaining, regulatory clearances or approvals for our future products or product modifications, our ability to commercially distribute and market these products could be adversely affected.
Our medical device products and operations are subject to extensive regulation in the United States by the FDA and by numerous federal, state, and foreign authorities, including comparable regulatory bodies such as the Health Products Regulatory Authority (“HPRA”) in Ireland. We are subject to strict governmental controls governing the development, manufacture, labelling, storage, testing, advertising, promotion, marketing, and distribution of our products, as well as the import and export of devices. In addition, we or our distributors, often must register with and/or obtain clearance or approval from foreign regulatory authorities before our products may be imported or sold in those markets. These clearance and approval processes vary across jurisdictions but are typically lengthy, detailed, and costly.
Obtaining and maintaining the regulatory clearances or approvals necessary to market a medical device can be expensive and time consuming, and we may not receive such clearances or approvals on a timely basis, or at all. In the United States, the FDA permits commercial distribution of a new medical device only after it has been cleared under Section 510(k) of the Federal Food, Drug, and Cosmetic Act (“FDCA”) or has received premarket approval (“PMA”), unless it is exempt. The FDA will clear a device through the 510(k) process if the manufacturer demonstrates substantial equivalence to a previously cleared device. Higher risk devices - such as life sustaining, life supporting, or implantable devices - or devices that are not substantially equivalent to a legally marketed predicate require PMA approval.
The PMA process is significantly more costly, time consuming, and uncertain than the 510(k) pathway. A PMA must include extensive technical, preclinical, clinical, manufacturing, and labelling data demonstrating the safety and effectiveness of the device. While 510(k) clearance typically takes three to twelve months, the PMA process usually requires one to three years or more from submission to approval. There is no assurance that we will obtain clearance or approval for any future products or modifications.
Many of our currently marketed products in the United States have received 510(k) clearance. If the FDA requires us to undergo more rigorous premarket review for future products or for modifications to existing products, our product introductions could be delayed or cancelled. The FDA may also determine that certain future products require PMA approval rather than 510(k) clearance.
The FDA may delay, limit, or deny clearance or approval for a variety of reasons, including:
our inability to demonstrate that our products are safe and effective for their intended uses;
insufficient data from preclinical studies or clinical trials; and
failure of our manufacturing processes or facilities to meet applicable requirements.
Additionally, the FDA may revise its clearance and approval policies, adopt new regulations, or modify existing regulations in ways that affect our ability to obtain or maintain clearances or approvals. Regulatory authorities may also disagree with our interpretation of existing policies, potentially resulting in required modifications, restrictions, or discontinuation of products - even if those products have previously been cleared or approved.
In the European Union, manufacturers of in vitro diagnostic medical devices are subject to the In Vitro Diagnostic Medical Device Regulation (Regulation (EU) 2017/746) (“IVDR”). Several categories of devices require assessment and certification by an independent Notified Body before the manufacturer may affix a CE mark.
The ongoing phased transition to the IVDR has significantly increased regulatory scrutiny, documentation requirements, and vigilance obligations for manufacturers, including us. As additional device classifications transition into full IVDR oversight, we expect more frequent updates to technical documentation, expanded post-market performance follow-up requirements, and heightened expectations for trend reporting and risk management. These evolving obligations may increase our regulatory workload and the likelihood that authorities or our Notified Body will request supplemental information or corrective actions.
Our continued success depends on our ability to commercialize new or enhanced products, some of which are currently awaiting clearance or approval. Such clearances or approvals may not be granted, may be delayed, or may be limited by significant restrictions. Regulatory authorities may impose conditions or limitations as part of the marketing authorization or may refuse authorization altogether - even if the product has been authorized without restrictions in another jurisdiction. Modifications to our products may invalidate previously granted approvals or clearances, requiring new submissions or leading to enforced restrictions or discontinuation.
On September 29, 2023, the FDA proposed a rule - adopted on April 29, 2024 - clarifying that in vitro diagnostic products (“IVDs”) are medical devices under the FDCA, including when manufactured by clinical laboratories. However, on March 31, 2025, the U.S. District Court for the Eastern District of Texas vacated the rule, holding that the FDA exceeded its statutory authority. As a result, the rule will not take effect unless reversed on appeal, and laboratories are not currently required to obtain FDA clearance to market laboratory developed tests (“LDTs”). If the ruling stands, FDA’s authority to regulate LDTs as devices may be substantially limited, and these tests may continue to be regulated primarily under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”).
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Failure to comply with FDA or other regulatory requirements may require us to suspend production of our products or conduct recalls, and could result in significant costs, reputational harm, and loss of revenue.
Even after receiving regulatory clearance or approval for our medical devices, we remain subject to extensive, ongoing post-market regulatory requirements. Regulation by the FDA and by numerous federal, state, and foreign authorities - including the Health Products Regulatory Authority (“HPRA”) in Ireland - affects nearly every aspect of our operations and those of our suppliers and distributors. These requirements govern manufacturing, labelling, packaging, adverse event reporting, storage, promotion, marketing, distribution, and import and export activities.
Our manufacturing operations, and those of our suppliers and distributors, must comply with the FDA’s medical device regulations and comparable foreign quality system requirements. These regulations govern the methods and documentation used in the design, testing, production, control, quality assurance, labelling, sterilization, storage, and shipping of medical devices. Our facilities, and the facilities of our suppliers and distributors, are subject to periodic inspections - announced and unannounced - by the FDA and foreign regulatory authorities to assess compliance with these regulations.
As the legal manufacturer, Trinity Biotech is responsible for managing product and regulatory risks across the end‑to‑end supply chain. While certain activities may be carried out by outsourced partners or distributors, Trinity Biotech maintains oversight of these services through its Quality Management System. Nevertheless, any failure by external parties to meet contractual obligations or to properly execute assigned activities could negatively impact Trinity Biotech’s regulatory standing and overall compliance status.
Regulatory agencies may also require post-marketing testing or surveillance to monitor the performance or safety of cleared or approved products and may impose restrictions or conditions on clearances or approvals that limit the commercial use of a product. Failure by us, or by any of our suppliers or distributors, to comply with applicable statutes or regulations - or failure to adequately address inspectional observations, deficiencies, or safety concerns - could result in enforcement actions, including:
untitled letters, warning letters, fines, injunctions, consent decrees, or civil penalties;
unanticipated expenditures in responding to or defending such actions;
customer notifications, product corrections, repairs, replacements, or refunds;
product recalls, detentions, or seizures;
operating restrictions or suspension or shutdown of manufacturing;
delays or refusals in granting 510(k) clearances or PMA approvals for new or modified products;
withdrawal or suspension of existing clearances or approvals;
restrictions on export or import activities; or
criminal prosecution.
Foreign regulatory authorities may impose similar sanctions within their respective jurisdictions.
Any of these actions could damage our reputation, reduce customer confidence, limit our ability to sell products, and negatively affect our financial performance. Additionally, if suppliers or contract manufacturers fail to comply with applicable requirements, we may be unable to obtain critical components or manufacture products in required quantities or on the timelines needed to support commercial demand.
Even when regulatory clearance or approval is granted, it may include limitations on the intended uses for which a product may be marketed. Such limitations can reduce the commercial potential of a product. If the FDA determines that our promotional materials, labelling, training, or other marketing activities promote an unapproved use, the agency may require us to cease or modify such activities or may take enforcement action. Other federal, state, or foreign enforcement authorities may also impose significant fines or penalties under fraud and abuse or reimbursement related statutes, including laws prohibiting false claims for payment.
We may also be required to conduct additional post-market testing or surveillance to assess ongoing safety or effectiveness, and we must comply with medical device reporting requirements for adverse events and malfunctions. Newly identified safety issues - such as unexpected adverse events, increases in event frequency or severity, or manufacturing defects - or failures to comply with regulations or other post-market obligations may result in labelling changes, product restrictions, product withdrawals from the market, voluntary or mandatory recalls, repair or replacement obligations, fines, import or export restrictions, suspension of approvals, injunctions, seizures, or civil or criminal penalties. Any of these consequences could adversely affect our business, operations, and prospects.
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In our ordinary course of business, we are frequently required to make interpretive or judgment-based decisions regarding compliance with complex and evolving regulatory requirements. If regulators disagree with our interpretations or determine that we have not complied fully with applicable laws, we could be subject to substantial civil or criminal penalties, as well as product seizures, recalls, or injunctions preventing sale of our products. Such penalties or restrictions could significantly damage our reputation and materially impair our ability to manufacture and market our products.
In addition to FDA and other device specific requirements, some foreign jurisdictions impose additional restrictions on the sale or distribution of medical devices. While we strive to comply with all applicable requirements, there can be no assurance that we will always be successful in obtaining or maintaining the clearances, approvals, or authorizations required to sell our products in particular markets.
We must also comply with numerous non-device-specific laws relating to environmental protection, safe working conditions, fire and hazard controls, handling and disposal of hazardous substances, and labour and employment practices. Compliance with these requirements, or with new or revised laws, could increase our operational costs. Because so many regulatory bodies and governmental agencies influence our operations, the full impact of these requirements is difficult to predict. If compliance costs become substantial, or if we are found not to be in compliance with any of these laws or requirements, our business and results of operations could be adversely affected.
Modifications to our products may require new 510(k) clearances or pre-market approvals, and in some cases may require us to cease marketing or recall the modified products until necessary clearances or approvals are obtained.
Any modification to a device cleared under Section 510(k) in the United States that could significantly affect its safety or effectiveness, or that results in a major change to its intended use, design, or manufacturing process, may require a new 510(k) submission or, in some cases, approval of a premarket approval application (“PMA”). Manufacturers are responsible for initially determining whether a modification triggers a new submission requirement; however, the FDA can review, question, or overrule these decisions at any time.
The FDA may not agree with our determination that certain product modifications do not require a new 510(k) notification or PMA. If the FDA disagrees and requires us to submit a new 510(k) or PMA for a modification to one of our previously cleared products, we could be required to cease marketing or recall the affected product until we obtain the necessary clearance or approval. We may also be subject to regulatory fines, penalties, or other enforcement actions.
In addition, our products may be subject to recall if the FDA determines that they are not safe or effective for their intended uses, regardless of whether a modification was involved. Any recall or requirement that we seek new clearances or approvals could result in significant delays, increased costs associated with redesign or validation, loss of revenue, adverse publicity, and potential operating restrictions imposed by the FDA.
We are subject to export controls and economic sanctions laws, and our customers and distributors are subject to import controls that could subject us to liability if we are not in full compliance with applicable laws.
Certain of our products are subject to U.S. export controls and sanctions regulations and we would be permitted to export such solutions to certain destinations outside the U.S. only by first obtaining an export license from the U.S. government, or by utilizing an existing export license exception/General License, or after clearing U.S. government agency review. Obtaining the necessary export license or accomplishing a U.S. government review for a particular export may be time-consuming and may result in the delay or loss of sales opportunities.
Although we take precautions to prevent our products from being provided in violation of U.S. export control and economic sanctions laws, our products may have been in the past, and could in the future be, provided inadvertently in violation of such laws. If we were to fail to comply with U.S. export law requirements, U.S. customs regulations, U.S. economic sanctions or other applicable U.S. laws, we could be subject to substantial civil and criminal penalties, including fines, incarceration for responsible employees and managers and the possible loss of export or import privileges. U.S. export controls, sanctions and regulations apply to our distributors as well as to us. Any failure by our distributors to comply with such laws, regulations or sanctions could have negative consequences, including reputational harm, government investigations and penalties.
Changes or new versions of our products or changes in export and import regulations may create delays in the introduction of our products into international markets, prevent our distributors from deploying our products globally or, in some cases, prevent the export or import of our products to certain countries, governments or persons altogether. In addition, any change in export or import regulations, economic sanctions or related legislation, shift in the enforcement or scope of existing regulations, or change in the countries, governments, persons or technologies targeted by such regulations, could result in decreased use of our products by, or in our decreased ability to export or sell our products to, existing or potential international customers. Any decreased use of our principal products or limitation on our ability to export or sell such products would likely adversely affect our business, financial condition and operating results.
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We are subject to anti-corruption, anti-bribery and similar laws, and non-compliance with such laws can subject us to criminal penalties or significant fines and harm our business and reputation.
We are subject to anti-corruption and anti-bribery and similar laws, such as the U.S. Foreign Corrupt Practices Act of 1977, as amended, or the Foreign Corrupt Practices Act, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the U.S. PATRIOT Act, the U.K. Bribery Act 2010, the Criminal Justice (Corruption Offences) Act 2018 and other anti-corruption, anti-bribery and anti-money laundering laws in countries in which we conduct activities. Anti-corruption and anti-bribery laws may be enforced aggressively and are interpreted broadly and prohibit companies and their employees and agents from promising, authorizing, making, offering, soliciting, or accepting, directly or indirectly, improper payments or other improper benefits to or from any person whether in the public or private sector. As we increase our international sales and business, our risks under these laws may increase. Noncompliance with these laws could subject us to investigations, sanctions, settlements, prosecution, other enforcement actions, disgorgement of profits, significant fines, damages, other civil and criminal penalties or injunctions, adverse media coverage and other consequences. Any investigations, actions or sanctions could adversely affect our business, results of operations and financial condition.
Changes in healthcare regulation could affect our revenues, costs and financial condition.
In the United States in recent years, there have been numerous initiatives at the federal and state level for comprehensive reforms affecting the payment for, the availability of and reimbursement for, healthcare services. These initiatives have ranged from proposals to fundamentally change federal and state healthcare reimbursement programs, including providing comprehensive healthcare coverage to the public under government-funded programs, to minor modifications to existing programs. One example is the Patient Protection and Affordable Care Act, the Federal healthcare reform law enacted in 2010 (the “Affordable Care Act”). Similar reforms may occur internationally.
Third party payors, such as Medicare and Medicaid in the United States, have reduced their reimbursements for certain medical products and services. Our business is impacted by the level of reimbursement available for clinical tests from third party payors. In the United States, payment for many diagnostic tests provided to Medicare fee‑for‑service beneficiaries is determined by the Medicare Clinical Laboratory Fee Schedule (CLFS), which is established and periodically updated by the Centers for Medicare & Medicaid Services (CMS). Some commercial payors are guided by the CLFS in establishing their reimbursement rates. Laboratories and clinicians may decide not to order or perform certain clinical diagnostic tests if third party payments are inadequate, and we cannot predict whether third party payors will offer adequate reimbursement for tests utilizing our products to make them commercially attractive. Legislation, such as the Affordable Care Act, as amended by the Health Care and Education Reconciliation Act and the Middle Class Tax Relief and Job Creation Act of 2012, has reduced the payments for clinical laboratory services paid under the CLFS. In addition, the Medicare for All Act of 2021 (M4A) has made significant changes to the way Medicare will pay for clinical laboratory services, which has further reduced reimbursement rates.
Legislative and regulatory bodies are likely to continue to pursue healthcare reform initiatives in many forms and may continue to reduce funding in an effort to lower overall federal healthcare spending. The U.S. government recently enacted legislation that eliminated what is known as the “individual mandate” under the Affordable Care Act and may enact other changes in the future. The ultimate content and timing of any of these types of changes in other healthcare reform legislation and the resulting impact on us are impossible to predict. If significant reforms are made to the healthcare system in the U.S., or in other jurisdictions, those reforms may increase our costs or otherwise have an adverse effect on our financial condition and results of operations.
Our laboratory business could be harmed by the loss or suspension of a license, accreditation, or certification, or by the imposition of fines or penalties under CLIA or applicable state laws, as well as by future changes in regulatory requirements, reimbursement rates, or testing methodologies.
Our clinical laboratory, operated by our Immco Diagnostics Inc. subsidiary (“Immco”), is subject to the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), which are administered by CMS. CLIA extends federal oversight to virtually all clinical laboratories by requiring certification either directly from CMS or through a CMS approved accreditation organization. CLIA is intended to ensure the quality and reliability of clinical testing by establishing standards related to personnel qualifications, administration, proficiency testing, patient test management, quality control, quality assurance, documentation, and routine inspections. Laboratories must undergo onsite surveys at least every two years, which may be conducted by CMS or by a CMS approved accrediting body such as the College of American Pathologists (“CAP”). Failure to comply with CLIA requirements may result in suspension, limitation, or revocation of a laboratory’s CLIA certificate - as well as civil monetary penalties or, in severe cases, criminal sanctions.
In addition to CLIA, our laboratory services are subject to state clinical laboratory laws of New York and certain other states and may be subject to additional state requirements as our testing footprint expands. These laws may impose personnel qualification requirements, mandate specific quality control procedures, establish facility standards, or require ongoing inspections. For example, California requires laboratories performing tests on California residents to maintain a state laboratory license and comply with state specific standards governing personnel, operations, and quality control. Some states impose requirements that are more stringent than CLIA, particularly with respect to personnel qualifications and documentation.
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If we fail to comply with CLIA or applicable state laws, we could face significant civil or administrative penalties, experience suspension or loss of one or more laboratory licenses or certifications, or be barred from accepting specimens from patients in certain states. The loss, suspension, or denial of any required license, certification, accreditation, or permit could materially harm our business, limit our testing volume, impair our ability to serve patients and providers, and negatively impact our financial results.
In addition to federal and state regulators, commercial payors and accreditation bodies may impose their own operational requirements - sometimes more stringent than regulatory requirements - which may affect test methodologies, validation practices, or quality management systems. Failure to meet such third-party standards can result in loss of accreditation or pay or network status, restricting reimbursement or access to certain patient populations.
Our laboratory business is also subject to risk from changes in reimbursement policies, reimbursement rates, and coverage determinations by government programs and commercial payors, as well as shifts in preferred or reimbursable testing methodologies. CMS, state Medicaid programs, and private payors may modify payment rates, billing rules, or coverage criteria for particular assays, disease states, or testing approaches, including changes that favor alternative technologies or methodologies over those currently used by our laboratory. In addition, payors may reassess clinical utility, cost‑effectiveness, or coding and payment treatment for certain tests, which could result in reduced reimbursement, denial of coverage, increased documentation or prior authorization requirements, or delays in payment. If reimbursement rates decline, coverage policies change, or testing methodologies evolve in a manner that disadvantages our assays or platforms, we may be required to modify or replace existing tests, invest in new technologies, or discontinue certain offerings, any of which could adversely affect our margins, test volumes, and financial performance.
The regulatory landscape for clinical laboratories continues to evolve. Even following the 2025 federal court decision vacating the FDA’s attempt to regulate laboratory developed tests (“LDTs”) as medical devices, future legislative or regulatory activity could lead to new requirements for test validation, quality system controls, premarket submissions, or adverse event reporting applicable to LDT providers. Individual states may also adopt new or more stringent requirements, creating inconsistent or overlapping compliance obligations. Any such changes could increase compliance costs, delay the introduction of new tests, impose additional administrative burdens, or require changes to our laboratory workflows or operations.
Any failure to comply with CLIA, state laboratory laws, accreditation standards, or future regulatory requirements could cause significant business disruption, reduce revenue, impair our reputation with physicians and patients, or limit our ability to operate our laboratory.
We are also subject to various federal and state laws targeting fraud and abuse in the healthcare industry.
If we fail to comply with federal and state health care laws, including fraud and abuse, false claims, physician payment transparency and privacy and security laws, we could face substantial penalties and our business, operations and financial condition could be adversely affected. We are subject to anti-kickback laws, self-referral laws, false claims laws, and laws constraining the sales, marketing and other promotional activities of manufacturers of medical devices by limiting the kinds of financial arrangements we may enter into with physicians, hospitals, laboratories and other potential purchasers of our products. The laws that may affect our ability to operate include, but are not limited to:
the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs, such as the Medicare and Medicaid programs. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it to have committed a violation; in addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;
the Physician Self-Referral Law, also known as the “Stark Law”, which provides for strict liability for referrals by physicians to entities with which they or their immediate family members have a financial arrangement for certain designated health services, including clinical laboratory services provided by our CLIA-certified laboratory owned and operated by our subsidiary Immco Diagnostics Inc., that are reimbursable by federal healthcare programs, unless an exception applies. Penalties for violating the Stark Law include denial of payment, civil monetary penalties, and exclusion from federal health care programs;
federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other federal third-party payers that are false or fraudulent. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual on behalf of the government and such individuals, commonly known as “whistleblowers”, may share in any amounts paid by the entity to the government in fines or settlement.
the federal Civil Monetary Penalties Law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier;
federal criminal laws that prohibit executing a scheme to defraud any federal healthcare benefit program or making false statements relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;
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the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information;
the federal Physician Payment Sunshine Act, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the CMS, information related to payments or other “transfers of value” made to physicians, teaching hospitals and others, and requires applicable manufacturers to report annually to the government ownership and investment interests held by the physicians described above and their immediate family members and payments or other “transfers of value” to such physician owners. We cannot assure you that we have and will successfully report all transfers of value by us, and any failure to comply could result in significant fines and penalties;
federal and state laws governing the certification and licensing of clinical laboratories, including operational, personnel and quality requirements designed to ensure that testing services are accurate and timely, and federal and state laws governing the health and safety of clinical laboratory employees;
the U.S. Foreign Corrupt Practices Act, or the FCPA, which prohibits corporations and individuals from paying, offering to pay or authorising the payment of anything of value to any foreign government official, government staff member, political party or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity; the UK Bribery Act, which prohibits both domestic and international bribery, as well as bribery across both public and private sectors; and bribery provisions contained in the German Criminal Code, which makes the corruption and corruptibility of physicians in private practice and other healthcare professionals a criminal offense; and
analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any payor, including commercial insurers; state laws that require device companies to comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbours available under such laws, it is possible that some of our business activities, including our relationships with physicians and other healthcare providers, some of whom may recommend, purchase and/or order our tests, our sales and marketing efforts and certain arrangements with customers, including those where we provide our instrumentation for free in exchange for minimum purchase requirements of our reagents, and our billing and claims processing practices, could be subject to challenge under one or more of such laws. A business arrangement that does not substantially comply with a safe harbour, however, is not necessarily illegal under the Anti-Kickback Statute, but may be subject to additional scrutiny by the government. We are also exposed to the risk that our employees, independent contractors, principal investigators, consultants, vendors and distributors may engage in fraudulent or other illegal activity. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business.
To enforce compliance with the federal laws, the U.S. Department of Justice (“DOJ”), has increased its scrutiny of interactions between health care companies and health care providers, which has led to a number of investigations, prosecutions, convictions and settlements in the health care industry. Dealing with investigations can be time and resource consuming and can divert management’s attention from the business. In addition, because of the potential for large monetary exposure under the federal False Claims Act, which provides for treble damages and substantial mandatory minimum penalties per false claim or statement, healthcare providers often resolve allegations without admissions of liability for significant and material amounts to avoid the uncertainty of treble damages that may be awarded in litigation proceedings. Such settlements often contain additional compliance and reporting requirements as part of a consent decree or corporate integrity agreement. Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business.
Changes in or evolving interpretations of these laws, regulations, or administrative or judicial interpretations, may require us to change our business practices or subject our business practices to legal challenges, which could have a material adverse effect on our business, financial condition and results of operations.
We have been, and may in the future be, a party to various lawsuits, demands, claims, qui tam suits, governmental investigations and audits (including investigations or other actions resulting from our obligation to self-report suspected violations of law) and other legal matters, any of which could result in, among other things, substantial financial penalties or awards against us, mandated refunds, substantial payments made by us, required changes to our business practices, exclusion from participation in federal and state healthcare programs and possible criminal penalties, any of which could have a material adverse effect on our business, results of operations, financial condition and cash flows and materially harm our reputation.
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Compliance with regulations governing public company corporate governance and reporting is complex and expensive.
Many laws and regulations impose obligations on public companies, which have increased the scope, complexity and cost of corporate governance, reporting and disclosure practices. Our implementation of certain aspects of these laws and regulations has required and will continue to require substantial management time and oversight and may require us to incur significant additional accounting and legal costs. We continually evaluate and monitor developments with respect to new and proposed rules and cannot predict or estimate the ultimate amount of additional costs we may incur or the timing of such costs. These laws and regulations are also subject to varying interpretations, in many cases due to their lack of specificity, and as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. Although we are committed to maintaining high standards of corporate governance and public disclosure, if we fail to comply with any of these requirements, legal proceedings may be initiated against us, which may adversely affect our business.
We may be unable to protect or obtain proprietary rights that we utilise or intend to utilise.
In developing and manufacturing our products, we employ a variety of proprietary and patented technologies. In addition, we have licensed, and expect to continue to license, various complementary technologies and methods from academic institutions and public and private companies. We cannot provide any assurance that the technologies that we own or license provide protection from competitive threats or from challenges to our intellectual property. In addition, we cannot provide any assurances that we will be successful in obtaining licenses or proprietary or patented technologies in the future, or that licenses granted to us by third parties will not be granted to other third parties who could potentially compete with us.
From time-to-time, certain companies have asserted exclusive patent, copyright and other intellectual property rights to technologies that are important to the industry in which we operate. If any of such claims relate to our planned products, we intend to evaluate such claims and, if appropriate, seek a license to use the protected technology. There can be no assurance that we would be able to obtain license to use such technology or, obtain such licenses on satisfactory commercial terms. If we or our suppliers are unable to obtain or maintain a license to any such protected technology that might be used in our products, we could be prohibited from marketing such products. We could also incur substantial costs to redesign our products or to defend any legal action taken against us. If our products should be found to infringe protected technology, we could also be required to pay damages to the infringed party.
Filing, prosecuting and defending patents covering our current and future products throughout the world would be prohibitively expensive. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we may obtain patent protection, but where patent enforcement is not as strong as that in the United States. These products may compete with our products in jurisdictions where we do not have any issued or licensed patents and any future patent claims or other intellectual property rights may not be effective or sufficient to prevent them from so competing.
The scope of the patent protection we obtain may not be sufficiently broad to compete effectively in our markets; our patent applications could be rejected or the existing patents could be challenged; and trade secrets and confidential know-how could be obtained by competitors.
We currently own a number of active patents, some with protection across multiple countries. Patents have a life of up to 20 years, and we generally file new patents on an ongoing basis to protect our intellectual property. We may fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. The patent applications that we own, or in-license, may fail to result in issued patents with claims that cover our current products or any future products in the United States or in other foreign countries. There is no assurance that all of the potentially relevant prior art relating to our patents and patent applications has been found, which can invalidate a patent or prevent a patent from issuing from a pending patent application.
We can provide no assurance that third parties will not challenge the validity, enforceability or scope of the patents we may apply for, or obtain, which may result in such patents being narrowed, invalidated, or held unenforceable. Any successful opposition to these patents or any other patents owned by or licensed to us could deprive us of rights necessary for the successful commercialization of any products covered by those patents.
Trade secrets and confidential know-how are important to our scientific and commercial success. Although we seek to protect our proprietary information through confidentiality agreements and other contracts, we can provide no assurance that others will not independently develop the same or similar information or gain access to our proprietary information.
Further, if we encounter delays in regulatory approvals, the period of time during which we could market a product under patent protection could be reduced. We can provide no assurance that our patents will continue to be commercially valuable.
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Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
Periodic maintenance fees on any issued patent are due to be paid to the United States Patent and Trademark Organization (“USPTO”) and other foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign national or international patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of patent rights include, but are not limited to, failure to timely file national and regional stage patent applications based on our international patent application, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. If we or our licensors fail to maintain the patents and patent applications covering our current or future products, our competitors might be able to enter the market, which would have an adverse effect on our business.
Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
As is the case with other biotechnology companies, our success is heavily dependent in intellectual property, particularly patents. Obtaining and enforcing patents in the biotechnology industries involve both technological and legal complexity. Therefore, obtaining and enforcing related patents is costly, time-consuming and inherently uncertain. The U.S. Supreme Court and the U.S. Court of Appeals for the Federal Circuit have ruled on several patent cases in recent years, and could do so again in the future, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition, the USPTO has implemented patentability guidelines that may render the subject matter of a patent as non-patentable based on a lack of utility. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by applicable courts and legislatures in the countries in which we may pursue patent protection, including those of the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents and the interpretations of such laws could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.
Product infringement claims by other companies could result in costly disputes and could limit our ability to sell our products.
Litigation over intellectual property rights is prevalent in the diagnostic industry, including patent infringement lawsuits, interferences, derivation and administrative law proceedings, inter party review, and post-grant review before the USPTO, as well as oppositions and similar processes in foreign jurisdictions.
As the market for diagnostics continues to grow and the number of participants in the market increases, we may increasingly be subject to patent infringement claims. It is possible that a third-party may claim infringement against us. For example, because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that our products may infringe. The biosensor industry, including the CGM industry, is a highly innovative area with a number of industry participants developing intellectual property portfolios over many years. As such there can be no guarantee that the technology acquired from Waveform or further developed by us, will not infringe on other parties’ existing IP portfolios.
Defence of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of managerial and financial resources from our business. Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialise one or more of our products. The pendency of any litigation may cause our distributors and customers to reduce or terminate purchases of our products. If found to infringe, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our affected products, which may be impossible or require substantial time and monetary expenditure. Any substantial loss resulting from such a claim could cause our revenues to decrease and have a material adverse effect on our profitability, and the damage to our reputation in the industry could have a material adverse effect on our business.
If we need to obtain a license as a result of litigation, we cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms. Furthermore, even in the absence of litigation, we may need to obtain licenses from third parties to advance our research or allow commercialisation of our products. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, we would be unable to further develop and commercialise one or more of our products, which could harm our business significantly.
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We may be involved in lawsuits to enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time consuming and unsuccessful.
Competitors may infringe or otherwise violate our patents, the patents of our licensors or our other intellectual property rights. To counter infringement or unauthorised use, we may be required to file legal claims, which can be expensive and time-consuming. In certain cases, we may be actively evaluating or preparing potential enforcement actions relating to our diagnostic technologies, and there can be no assurance that any such actions, if pursued, would be successful. In addition, in an infringement proceeding, a Court may decide that a patent of ours or our licensors is not valid or is unenforceable or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation or defence proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing. The initiation of a claim against a third party may also cause the third party to bring counter claims against us such as claims asserting that our patents are invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, non-enablement or lack of statutory subject matter. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant material information from the USPTO, or made a materially misleading statement, during prosecution. Third parties may also raise similar validity claims before the USPTO in post-grant proceedings such as ex parte re-examinations, inter partes review, or post-grant review, or oppositions or similar proceedings outside the United States, in parallel with litigation or even outside the context of litigation. The outcome following legal assertions of invalidity and unenforceability is unpredictable.
We cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. For the patents and patent applications that we have licensed, we may have limited or no right to participate in the defence of any licensed patents against challenge by a third party. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of any future patent protection on our current or future products. Such a loss of patent protection could harm our business.
We may not be able to prevent, alone or with our licensors, misappropriation of our intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the United States. Our business could be harmed if, in litigation, the prevailing party does not offer us a license on commercially reasonable terms. Any litigation or other proceedings to enforce our intellectual property rights may fail, and even if successful, may result in substantial costs and distract our management and other employees.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have an adverse effect on the price of our ADSs.
Risks Related to Ownership of our ADSs
Perceptive and MiCo own, or are entitled to acquire, a significant percentage of the voting share capital of our Company, which may give each of them a significant influence over our management and affairs and may deter a change in control or other transaction that may otherwise be favorable to our shareholders.
MiCo owns 2.2 million of our ADSs, which represents approximately 11.2% of the outstanding voting share capital of our Company (16.5% on a fully diluted basis, including shares issuable upon conversion of the convertible note issued to MiCo). Based on public filings, we understand that on December 2, 2025, MiCo was acquired by AI N M NET Limited as a result of a share purchase agreement with Dayli Trinity Holdings Limited. Under the terms of the MiCo convertible note and the purchase agreement for those ADSs, MiCo is entitled to nominate a total of up to four individuals, three of whom must be independent of MiCo, for consideration by the nomination committee of the board of directors of the Company for appointment as directors for as long as MiCo continues to hold qualifying amounts of ADSs or principal value of the convertible note or converted ADSs, as applicable. Because of its ownership interest and right to nominate directors, MiCo may have significant influence over our management and affairs and over matters requiring shareholder approval, including the election of directors and significant corporate transactions, such as a merger or other sale of our Company or our assets, for the foreseeable future. This concentration of ownership may also delay, deter or prevent a change in control, and may make some transactions more difficult or impossible to complete without the support of MiCo, regardless of the impact of such transactions on our other shareholders. The interests of MiCo may differ from the interests of other shareholders and thus result in corporate decisions that are disadvantageous to other shareholders.
Perceptive, our principal lender, beneficially owns, on a fully diluted basis, approximately 9.9% of the outstanding voting share capital of our Company based on a Schedule 13D/A filed with the SEC on January 26, 2026. Perceptive does not currently own any ADSs of the Company. Its reported beneficial ownership includes ADSs issuable upon conversion of its senior convertible note, the exercise of outstanding warrants and the settlement of milestone and contingent payment obligations, all of which are subject to a 9.9% beneficial ownership cap limiting the number of ADSs Perceptive may acquire at any one time. Because of its ownership interest and its position as the Company’s principal lender, Perceptive may have significant influence over our management and affairs for the foreseeable future. This concentration of ownership may also delay, deter or prevent a change in control, and may make some transactions more difficult or impossible to complete without the support of Perceptive, regardless of the impact of such transactions on our other shareholders.
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The Nasdaq Global Select Market imposes listing standards on our ADSs that we are currently not in compliance with and may not be able to fulfill in the future, thereby leading to a possible delisting of our ADSs.
As a listed Nasdaq Global Select Market company, we are subject to various listing standards. There can be no assurance that we will be able to meet all of the criteria necessary for Nasdaq to allow our ADSs to remain listed.
On February 11, 2026 and February 19, 2026, we received two deficiency letters from the Listing Qualifications Department of Nasdaq (the “Staff”). One deficiency letter notified us that we are not in compliance with the minimum market value of publicly held shares (“MVPHS”) requirement of the Nasdaq Listing Rules applicable to companies listed on the Nasdaq Global Select Market. For continued listing, companies are required to maintain a minimum MVPHS of US$15 million. A failure to meet the minimum MVPHS requirement exists if the deficiency continues for a period of 30 consecutive business days. The other deficiency letter notified us that for the preceding 30 consecutive business days, the ADSs did not maintain a minimum closing bid price of US$1.00 (the “Minimum Bid Price”) per ADS, as required by Nasdaq Listing Rule 5450(a)(1).
In accordance with the Nasdaq Listing Rules, we have 180 calendar days from the date of the deficiency notices, or until August 10, 2026 to regain compliance with the minimum MVPHS requirement and the Minimum Bid Price requirement.
To regain compliance with the MVPHS requirement, the Company’s MVPHS must exceed $15 million for a minimum of ten consecutive business days. If the Company does not regain compliance with the minimum MVPHS requirement by August 18, 2026 Nasdaq will provide written notification to the Company that its ADSs are subject to delisting. At that time, the Company may appeal the relevant delisting determination to a hearings panel pursuant to the procedures set forth in the applicable Nasdaq Listing Rules; however, there can be no assurance that the Company will satisfy the minimum MVPHS requirement or that any such appeal would be successful.
To regain compliance with the Minimum Bid Price requirement, the closing bid price of the Company’s ADSs must meet or exceed US $1.00 for at least ten consecutive business days during the 180-calendar day cure period. In the event the Company does not regain compliance with the Minimum Bid Price Requirement in that period, we may be eligible for an additional 180 calendar day grace period if we meet the continued listing requirement for MVPHS and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price and provide written notice to the Staff of our intention to cure the deficiency during the second compliance period. However, if it appears to the Staff that we will not be able to cure the deficiency, or if we are otherwise not eligible, Nasdaq will provide notice to us that our ADSs will be subject to delisting.
If our ADSs are ultimately delisted from Nasdaq and we are unable to successfully transfer the listing of our ADSs to The Nasdaq Capital Market, our ADSs would likely then trade only in the over-the-counter market and the market liquidity of our ADSs could be adversely affected and their market price could decrease. If our ADSs were to trade on the over-the-counter market, selling our ADSs could be more difficult because smaller quantities of shares would likely be bought and sold, transactions could be delayed, and we could face significant material adverse consequences, including: a limited availability of market quotations for our securities; reduced liquidity with respect to our securities; a determination that our shares are a “penny stock,” which will require brokers trading in our securities to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our securities; a reduced amount of news and analyst coverage for our Company; and a decreased ability to issue additional securities or obtain additional financing in the future. These factors could result in lower prices and larger spreads in the bid and ask prices for our ADSs and would substantially impair our ability to raise additional funds and could result in a loss of institutional investor interest and fewer development opportunities for us.
We are a foreign private issuer under the rules and regulations of the SEC and are therefore exempt from a number of rules under the Exchange Act and are permitted to file less information with the SEC than a domestic U.S. reporting company, which reduces the level and amount of disclosure that you receive.
As a foreign private issuer under the Exchange Act, we are exempt from certain rules under the Exchange Act, including the proxy rules, which impose certain disclosure and procedural requirements for proxy solicitations. Moreover, we are not required to file periodic reports and financial statements with the SEC as frequently or as promptly as domestic U.S. companies with securities registered under the Exchange Act; and are not required to comply with Regulation FD, which imposes certain restrictions on the selective disclosure of material information. Accordingly, you receive less information about our company than you would receive about a domestic U.S. company and are afforded less protection under the U.S. federal securities laws than you would be afforded in holding securities of a domestic U.S. company. For example, we are not required to file quarterly reviewed financial statements with the SEC and we are permitted to disclose limited compensation information for our executive officers on an individual basis.
As of March 18, 2026, our officers and directors are no longer exempt from the reporting provisions of Section 16 of the Exchange Act. Our principal shareholders continue to remain exempt from the reporting requirements contained in Section 16(a) of the Exchange Act and our officers, directors and principal shareholders continue to remain exempt from the short-swing profit recovery provisions contained in Section 16(b) of the Exchange Act.
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As a foreign private issuer whose ADSs are listed on NASDAQ, we are permitted to follow certain home country practices instead of certain requirements of the NASDAQ listing rules. Among other, as a foreign private issuer we follow home country practice with regard to, the composition of the board of directors, director nomination procedure, compensation disclosure of officers and quorum at shareholders’ meetings. In addition, we follow our home country law, instead of the NASDAQ listing rules, which require that we obtain shareholder approval for certain dilutive events, such as for the establishment or amendment of certain equity based compensation plans, an issuance that will result in a change of control of the company, certain transactions other than a public offering involving issuances of a 20% or more interest in our company and certain acquisitions of the stock or assets of another company. Accordingly, our shareholders may not be afforded the same protection as provided under NASDAQ’s corporate governance rules.
The market price of our ADSs has been, and may continue to be, highly volatile, and such volatility could cause the market price of our ADSs to decrease and could cause you to lose some or all of your investment in our ADSs.
The stock market in general and the market prices of the ADSs on Nasdaq, in particular, are or will be subject to fluctuation, and changes in these prices may be unrelated to our operating performance. Historically, the market price of our ADSs has fluctuated and during the period from January 2025 through March 2026, the market price of our ADSs fluctuated from a high of US$0.96 per ADS to a low of US$0.50 per ADS. We anticipate that the market prices of our ADSs will continue to be subject to wide fluctuations. The market price of our ADSs may be subject to a number of factors, including:
announcements of new products by us or others;
announcements by us of significant acquisitions, disposals, strategic partnerships, in-licensing, joint ventures or capital commitments;
the developments of the businesses and projects of our various subsidiaries;
expiration or termination of licences, research contracts or other collaboration agreements;
public concern as to the safety of the products we sell;
the volatility of market prices for shares of companies with whom we compete;
developments concerning intellectual property rights or regulatory approvals;
variations in our and our competitors’ results of operations;
changes in revenues, gross profits and earnings announced by us;
changes in estimates or recommendations by securities analysts, if the ADSs are covered by analysts;
changes in government regulations or patent decisions; and
general market conditions and other factors, including factors unrelated to our operating performance.
These factors may materially and adversely affect the market price of our securities and result in substantial losses by our investors.
We will need additional capital in the future to meet our working capital and business development expenditures. If additional capital is not available, we may not be able to continue to operate our business pursuant to our business plan or we may have to discontinue our operations entirely.
We will require additional capital in the future to fund our operations, product development and business development initiatives. If we continue to incur losses, we will need significant additional financing, which we may seek through a combination of private and public equity offerings, debt financing, asset sales, or other means. We have entered into a Standby Equity Purchase Agreement (“SEPA”) with an affiliate of Yorkville Advisors, pursuant to which we may sell up to US$25,000,000 of ADSs at our election, subject to certain caps and volume restrictions that may significantly limit the amount we are able to sell in practice, and we have entered into the Perceptive Conversion Documents, which, while they reduce our outstanding indebtedness upon conversion, do not generate new cash proceeds for the Company. Neither of these arrangements ensures that we will have sufficient capital to fund our operations and strategic initiatives. The extent to which we rely on the SEPA as a source of funding will depend on a number of factors, including the prevailing market price of our ADSs and the extent to which we are able to secure working capital from other sources.
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To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our shareholders will be diluted, and the terms of any such offerings may include liquidation or other preferences that may adversely affect the then-existing shareholders’ rights. Our outstanding convertible instruments with Perceptive and the SEPA already provide for substantial potential dilution, any additional equity or equity-linked financing could compound such dilution. Our ability to raise additional capital may also be impaired by the large number of ADSs that may be issued under those existing arrangements and our outstanding warrants and options, as well as the recent trading price of our ADSs, which has been below US$1.00. Although we have the ability to implement a change in the ratio of our ordinary shares represented by each ADS, there can be no assurance that such action would be implemented or successful in improving the trading price of our ADSs or facilitating capital‑raising transactions. These factors, individually and in combination, could make it more difficult to raise capital on acceptable terms and may put additional strain on our ability to satisfy the continued listing requirements of Nasdaq.
In recent years, we have relied on debt financing from Perceptive and have received additional term loans from Perceptive from time to time, in some cases in exchange for the issuance of additional warrants or the repricing of existing warrants to reflect lower prevailing share prices. Any further debt financing, whether from Perceptive or otherwise, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring debt or making capital expenditures. If we raise additional funds through collaboration, strategic alliance, or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, or product candidates, or grant licenses on terms that are not favorable to us.
Future sales of our ADSs, including upon conversion of our outstanding convertible instruments, exercise of warrants, and sales under our committed equity financing, could reduce the market price of our ADSs and impair our ability to raise capital.
Substantial sales of our ADSs, or the perception that such sales may occur, could cause the market price of our ADSs to decline. There are a number of sources from which a significant volume of ADSs may enter the public market in the near term:
Under the Perceptive Conversion Documents, Perceptive may convert up to US$72,500,000 in outstanding principal under the Credit Agreement and US$12,500,000 of other amounts owed to Perceptive into ADSs at its sole discretion. We do not control the timing of conversions, and Perceptive may resell any ADSs it receives upon conversion in the public market at any time.
Pursuant to the SEPA, we may sell up to US$25,000,000 of ADSs to Yorkville at a discount to the volume‑weighted average price (“VWAP”), subject to certain caps and volume restrictions that may significantly limit the amount we are able to sell in practice. We expect Yorkville to resell any ADSs it acquires under the SEPA, and such resales may cause the trading price of our ADSs to decline.
We have outstanding warrants for up to 66,200,000 ordinary shares (3,310,000 ADSs) and outstanding share options for up to 40,017,505 ordinary shares (2,000,876 ADSs).
24,691,358 ordinary shares (represented by 1,234,568 ADSs) are issuable upon conversion of the MiCo Convertible Note.
The cumulative effect of potential conversions under the Perceptive Conversion Documents and Mico Convertible Note, sales pursuant to the SEPA, and the exercise of warrants and options means that a very large number of additional ADSs could be issued and sold in the public market, which may make it more difficult for us to sell equity or equity-related securities in the future at a time and price that we deem appropriate, and may adversely affect the market price of our ADSs regardless of whether conversions, exercises, or sales have actually occurred. Our ADSs have recently been trading below US$1.00, and the potential for the issuance and resale of a substantial number of additional ADSs may contribute to continued downward pressure on the trading price and impair our ability to maintain compliance with the listing requirements of Nasdaq.
The conversion or exercise of our outstanding convertible instruments, share options, and warrants, and sales of ADSs under our committed equity financing, could significantly dilute the ownership interest of existing shareholders.
We have issued a number of convertible instruments, warrants, and share options that, if converted or exercised, would result in substantial dilution to existing shareholders. In particular, in December 2025, we entered into a series of agreements with funds managed by Perceptive Advisors (collectively, “Perceptive”) pursuant to which Perceptive may elect to convert up to US$72,500,000 in outstanding principal under the Credit Agreement and US$12,500,000 of other amounts owed to Perceptive into ADSs (the “Perceptive Conversion Documents”). Conversions under the Perceptive Conversion Documents are at Perceptive’s election - the Company does not control the timing, volume, or frequency of conversions. The conversion price under the Perceptive Conversion Documents is 97% of the volume weighted average price (“VWAP”) of our ADSs, subject to a minimum conversion price of US$0.5061 per ADS (equal to 75% of the 30 day VWAP of the Company’s ADSs for the period ended April 22, 2026). Based on this minimum conversion price, full conversion could result in the issuance of approximately 168,000,000 ADSs, representing an aggregate of approximately 3,360,000,000 ordinary shares (each ADS representing 20 ordinary shares).
As of April 30, 2026, there were 405,017,380 ordinary shares outstanding. Accordingly, the ordinary shares issuable upon full conversion of the Perceptive Conversion Documents at the Floor Price would represent approximately 829% of our currently outstanding ordinary shares. Although conversions under the Perceptive Conversion Documents are subject to a 9.9% beneficial ownership cap, this cap limits only the number of ordinary shares and ADSs Perceptive may beneficially own at any given time and does not restrict the total number of ADSs that may ultimately be issued over time.
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In addition, on February 24, 2026, we entered into a Standby Equity Purchase Agreement (the “SEPA”) with YA II PN, LTD. (“Yorkville”), pursuant to which we may, at our option, sell to Yorkville up to $25,000,000 in aggregate gross purchase price of ADSs at a discount to the recent VWAP of our ADSs, subject to certain volume and other limitations. Unlike the Perceptive Conversion Documents, the SEPA does not include a floor price, meaning that if our ADS trading price declines, we would be required to issue a greater number of ADSs to raise a given amount of capital.
We also have outstanding warrants exercisable for up to 66,200,000 ordinary shares (3,310,000 ADSs) with exercise prices ranging from US$0.80 to US$0.86, share options exercisable for up to 40,017,505 ordinary shares (2,000,876 ADSs) with exercise prices ranging from US$0.12 to US$1.10 and a convertible note held by Mico IVD Holdings, LLC (the “MiCo Convertible Note”), convertible into 24,691,358 ordinary shares (1,234,568 ADSs) at conversion price of US$16.20 per ADS. The exercise of these warrants or options or conversion of the MiCo Convertible Note would further dilute the ownership interests of existing shareholders.
In the aggregate, if all of our outstanding convertible instruments, warrants, and share options were fully converted or exercised, and assuming the SEPA were fully utilized, the resulting issuances could, on the one hand, substantially reduce our debt and interest costs, it could also dilute the ownership interest of existing shareholders by a very significant amount.
We may be classified as a passive foreign investment company, or PFIC, which would subject our U.S. investors to adverse tax rules.
U.S. holders of our ADSs may face income tax risks. Based on the composition of our income, assets (including the value of our goodwill, going-concern value or any other unbooked intangibles, which may be determined based on the price of the ordinary shares), and operations, we believe we will not be classified as a “passive foreign investment company”, or PFIC, for the 2025 taxable year. However, because PFIC status is based on our income, assets and activities for the entire taxable year, it is not possible to determine whether we will be characterized as a PFIC for our current taxable year or future taxable years until after the close of the applicable taxable year. Moreover, we must determine our PFIC status annually based on tests that are factual in nature, and our status in the current year and future years will depend on our income, assets and activities in each of those years and, as a result, cannot be predicted with certainty as of the date hereof. Furthermore, fluctuations in the market price of our ordinary shares may cause our classification as a PFIC for the current or future taxable years to change because the aggregate value of our assets for purposes of the asset test, including the value of our goodwill and unbooked intangibles, generally will be determined by reference to the market price of our shares from time to time (which may be volatile). The IRS or a Court may disagree with our determinations, including the manner in which we determine the value of our assets and the percentage of our assets that are passive assets under the PFIC rules. Therefore, there can be no assurance that we will not be a PFIC for the current taxable year or for any future taxable year. Our treatment as a PFIC could result in a reduction in the after-tax return to U.S. Holders (as defined below under Item 10E. “Additional Information – Taxation”) of our ADSs and would likely cause a reduction in the value of such shares. A foreign corporation will be treated as a PFIC for U.S. federal income tax purposes if either (1) at least 75% of its gross income for any taxable year consists of certain types of “passive income,” or (2) at least 50% of the average value of the corporation’s gross assets produce, or are held for the production of, such “passive income.” For purposes of these tests, “passive income” includes dividends, interest, gains from the sale or exchange of investment property and rents and royalties other than rents and royalties that are received from unrelated parties in connection with the active conduct of a trade or business. If we are treated as a PFIC, U.S. Holders of ADSs would be subject to a special adverse U.S. federal income tax regime with respect to the income derived by us, the distributions they receive from us, and the gain, if any, they derive from the sale or other disposition of their ADSs. U.S. Holders should carefully read Item 10E. “Additional Information – Taxation” for a more complete discussion of the U.S. federal income tax risks related to owning and disposing of ADSs.
It could be difficult for U.S. holders of ADSs to enforce any securities laws claims against us, our officers or our directors in Irish courts.
At present, no treaty exists between the United States and Ireland for the reciprocal enforcement of foreign judgments. Therefore, a final judgment for the payment of money rendered by any U.S. federal or state court based on civil liability, whether or not based solely on U.S. federal or state securities laws, would not automatically be recognized or enforceable in Ireland. A judgment of the U.S. courts will be enforced by the Irish courts, by way of separate action in Ireland, if the following general requirements are met:
the judgment is for a debt or a definite sum of money;
the procedural rules of the U.S. court must have been observed and the U.S. court must have had jurisdiction in relation to the particular defendant according to Irish conflict of law rules (the submission to jurisdiction by the defendant would satisfy this rule); and
the judgment must be final and conclusive and the decree must be final and unalterable in the U.S. court which pronounces it. A judgment can be final and conclusive even if it is subject to appeal or even if an appeal is pending. If the effect of lodging an appeal under the applicable law is to stay execution of the judgment, it is possible that, in the meantime, the judgment should not be actionable in Ireland. It remains to be determined whether final judgment given in default of appearance is final and conclusive.
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However, the Irish courts may refuse to enforce a judgment of the U.S. courts which meets the above requirements in certain circumstances, including:
if the judgment was impeached by fraud;
if the process and decision of the U.S. courts were contrary to natural or constitutional justice under the laws of Ireland and if the enforcement of the judgment in Ireland would be contrary to natural or constitutional justice; or
if the judgment is contrary to Irish public policy or involves certain United States laws which will not be enforced in Ireland or constitute the enforcement of a judgment of a penal or taxation nature.
An application to the Irish courts for the enforcement in Ireland of a judgment of the U.S. courts which meets the above requirements may also be successfully opposed if it can be demonstrated that:
jurisdiction cannot be obtained by the Irish courts over the judgment debtors in the enforcement proceedings by personal service in Ireland or outside Ireland under Order 11 of the Irish Superior Courts Rules;
there is no practical benefit to the party in whose favor the foreign judgment is made in seeking to have that judgment enforced in Ireland, or
the judgment is not consistent with a judgment of an Irish court in respect of the same matter.
We have no plans to pay dividends on our ADSs, and ADS holders may not receive funds without selling the ADSs.
We do not expect to pay any cash dividends on our ADSs for the foreseeable future. We currently intend to retain any additional future earnings to finance our operations and growth and, therefore, we have no plans to pay cash dividends at this time. Any future determination to pay cash dividends will be at the discretion of our board of directors and will be dependent on our earnings, financial condition, operating results, capital requirements, any contractual restrictions, and other factors that our board of directors deems relevant. Accordingly, ADS holders may have to sell some or all of the ADSs in order to generate cash from your investment. You may not receive a gain on your investment when you sell the ADSs and may lose the entire amount of your investment.
The voting rights of holders of ADSs are limited by the terms of the deposit agreement, and you may not be able to exercise your right to direct the voting of your A Ordinary shares underlying the ADSs.
Holders of ADSs do not have the same rights as our registered shareholders. As a holder of the ADSs, you will not have any direct right to attend general meetings of our shareholders, cast any votes at such meetings or otherwise exercise the rights of registered shareholders set out in our articles of association or in Irish law. You will only be able to exercise the voting rights which attach to the A Ordinary Shares underlying the ADSs indirectly by giving voting instructions to the depositary in accordance with the provisions of the deposit agreement. Under the deposit agreement with the depositary, you may vote only by giving voting instructions to the depositary, as the registered holder of the A Ordinary Shares underlying the ADSs. If the depositary asks for your instructions, then upon receipt of such voting instructions, it will try to vote the underlying A Ordinary Shares in accordance with those instructions. If we do not instruct the depositary to ask for your instructions, the depositary may still vote in accordance with instructions you give, but it is not required to do so. You will not be able to directly exercise any right to vote with respect to the underlying A Ordinary Shares unless you withdraw the shares underlying your ADSs and become the registered holder of such shares prior to the record date for the general meeting. When a general meeting is convened, you may not receive sufficient advance notice of the meeting to enable you to withdraw the shares underlying the ADSs and become the registered holder of such shares prior to the record date for such general meeting to allow you to attend the general meeting and to vote directly with respect to any specific matter or resolution to be considered and voted upon at the general meeting. Where any matter is to be put to a vote at a general meeting, upon our instruction, the depositary will notify you of the upcoming vote and deliver our voting materials to you. We cannot assure you that you will receive the voting materials in time to ensure you can direct the depositary to vote the A Ordinary Shares underlying your ADSs in accordance with your instructions. In addition, the depositary and its agents are not responsible for failing to carry out your voting instructions or for their manner of carrying out your voting instructions. This means that you may not be able to exercise your right to direct how the shares underlying the ADSs are voted and you may have no legal remedy if the shares underlying the ADSs are not voted as you instructed.
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Item 4.
We were incorporated in Ireland in 1992 as a private limited company and re-registered as a public limited company (“plc”) in July of that year. In October 1992 we completed an initial public offering of our securities in the United States and our ADS have traded on the Nasdaq Global Market since that time under the symbol “TRIB”.
The principal offices of our company are located at IDA Business Park, Bray, County Wicklow, Ireland. The Group has expanded its product base through internal development and acquisitions.
Our website address is https://www.trinitybiotech.com/. The information contained on, or that can be accessed from, our website does not form part of this Annual Report. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers, such as we, that file electronically, with the SEC at www.sec.gov.
Overview
We are a biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors. Following the acquisition of the biosensor assets of Waveform Technologies Inc. (“Waveform”) in 2024, we have been developing a range of biosensor devices and related services, beginning with a continuous glucose monitoring (“CGM”) product. Through our subsidiaries, we develop, acquire, manufacture and market medical diagnostic products for the clinical laboratory and point‑of‑care segments of the diagnostic market. Our products are used to detect autoimmune, infectious and sexually transmitted diseases, disorders of the liver and intestine, and to monitor markers for diabetes. We market our portfolio of several hundred products to customers in approximately 100 countries around the world through our own sales force and a network of international distributors and strategic partners.
While our executive offices are located at Bray, Ireland, our research and development, manufacturing and marketing activities are principally conducted by the following subsidiaries:
Trinity Biotech Manufacturing Limited, based in Bray, Ireland;
Konamite Limited, based in Bray, Ireland;
Clark Laboratories Inc, based in Jamestown, New York;
Primus Corporation, based in Kansas City;
Biopool US Inc (trading as Trinity Biotech USA), based in Jamestown, New York;
Immco Diagnostics Inc, based in Buffalo, New York;
Trib Biosensors Inc, based in Wilsonville, Oregon;
Nova Century Scientific Inc, based in Burlington, Canada;
Trinity Biotech Brazil based in Sao Paulo, Brazil;
Metabolomic Diagnostics Limited, based in Cork, Ireland; and
EpiCapture Limited, based in Bray, Ireland.
Principal Markets
The brand names of our principal products are listed below, organised first by point of use and second by application.
Point-of-care
Clinical Laboratory
Infectious Diseases
Haemoglobin
Autoimmune
Clinical Chemistry
Blood Bank Screening
UniGold
MarDx
Premier
ImmuBlot
EZ
Captia
TrinScreen
FlexTrans
Ultra
ImmuGlo
ImmuLisa
OTOblot
We sell our products through our direct sales organisations in the United States, Brazil and to an extent in the United Kingdom, France and Germany and then through our network of principal distributors and non-governmental bodies into approximately 100 countries globally.
We are currently developing the CGM device for optimization for broad adoption, evolving the technology to measure and analyse other valuable biomarkers and related datapoints. Our vision is to develop a portfolio of technologies that can offer users and clinicians valuable actionable health and wellness insights.
Point-of-care refers to diagnostic tests which are carried out in the presence of the patient.
Uni-Gold™ HIV
We believe that Trinity Biotech makes a very significant contribution to the global effort to meet the challenge of human immuno-deficiency virus, or HIV, with its principal product, Uni-Gold™ HIV. In Africa, Uni-Gold™ HIV has been used for many years in voluntary counselling and testing centers in the sub-Saharan region where it is a cornerstone to early detection and treatment intervention.
In Africa, HIV testing typically involves using a point-of-care rapid test for screening followed by a different rapid test as the confirmatory test. Our HIV screening test, TrinScreen, received World Health Organisation (“WHO”) approval in February 2022. We began commercial shipments of TrinScreen in 2023 and this ramped up significantly in 2024 and 2025.
Our Uni-Gold™ HIV product is a leading confirmatory HIV test in the African market.
In June 2025, we transitioned the upstream manufacturing processes for Uni-Gold™ HIV to an outsourced offshore model. In September 2025, following WHO regulatory approval, we commenced offshored and outsourced manufacturing of our TrinScreen HIV rapid test. We commenced the final phase of the Uni-Gold™ HIV manufacturing transition during the first quarter of 2026, enabling the transition of upstream manufacturing processes to commence in March 2026. These manufacturing transitions are intended to enhance supply‑chain resilience and scalability, alongside improving gross margins and better aligning our cost base with the inherent variability of global HIV testing demand.
We supply the clinical laboratory segment of the in-vitro diagnostic market with a range of diagnostic tests and instrumentation which detect:
Infectious diseases;
Glycated haemoglobin (for diabetes care) and haemoglobin variants for the detection of haemoglobinopathies (haemoglobin abnormalities); and
Autoimmune diseases.
We also supply this market with other products through our clinical chemistry business.
We manufacture kits for the detection of specialty and esoteric biomarkers of infectious diseases and other associated laboratory products. The products are used in processing patient samples whose results aid physicians in the diagnosis and clinical assessment of a broad range of infectious diseases. The key clinical laboratory disease areas that we serve include:
Sexually transmitted diseases, including Syphilis and Herpes;
Markers for Epstein Barr, Measles, Mumps, Toxoplasmosis, Cytomegalovirus, Rubella, Varicella and other viral pathogens, and
SARS-CoVS-2.
We also develop, manufacture and distribute products predominantly in enzyme-linked immunosorbent assay (“ELISA”) format.
Many of the products in our infectious diseases product line are FDA cleared for sale in the United States and CE marked in Europe. Products are sold in approximately 100 countries in total, with the focus on the Americas, Europe and Asia. The infectious disease products are sold through our sales and marketing organisation to a variety of customers including public health authorities, clinical and reference laboratories.
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Diabetes and Haemoglobinopathies
We manufacture products for in-vitro measurement of haemoglobin A1c (“HbA1c”) used in the monitoring of diabetes, as well identifying those who are at a high risk of developing diabetes (pre-diabetic). The Premier Hb9210 uses boronate affinity technology to measure HbA1c which is a marker of a patient’s average blood sugar control over the last 100 to 120 days. It is a highly accurate biomarker available for use in monitoring of diabetes and is a strong indicator of a diabetic’s glycemic control. HbA1c is also used to identify those at risk of becoming diabetic; often referred to as impaired glucose tolerance. Additionally, HbA1c is used in the assessment of diabetes complications.
We manufacture our own HbA1c instrument, the Premier Hb9210, which is both CE marked and FDA cleared. In the United States and Brazil, we sell the Premier Hb9210 through our own direct sales organisations. In the rest of the world, we sell the Premier Hb9210 through a network of distributors. The Premier’s unique features, cost structure and core technology enable it to compete in most economies and settings.
In early 2025, we introduced our next‑generation boronate‑affinity buffer column system for the Premier Hb9210, which delivers significantly increased testing capacity, improved column stability and reduced instrument downtime. In February 2026, the Premier Hb9210, incorporating this newly launched Buffer A Plus column system, became the only HbA1c analyser worldwide to receive the prestigious IFCC Gold Classification for 2026, representing the highest level of analytical precision and bias certification awarded by the International Federation of Clinical Chemistry. This recognition reflects the platform’s strong clinical accuracy and further strengthens the competitive position of the Premier Hb9210 in the global HbA1c testing market.
We also sell products for haemoglobin variants, through the Premier Resolution (CE cleared - meaning it can be sold in the EU). The Premier Resolution detects and identifies haemoglobinapothies. These are genetic defects that result in abnormal structure of the haemoglobin molecule. Haemoglobinapathies include sickle-cell diseases, alpha and beta thalassemia which are amongst the most common genetic disorders in the world.
We have launched the Premier Resolution, our next generation Haemoglobinapothy Analyzer in Europe and the Middle East after undergoing rigorous and successful field trials. In August 2023, the Premier Resolution was approved by the FDA allowing the instrument to be sold in the U.S.
Autoimmune Diseases
Autoimmune diseases are diseases that involve an abnormal immune response in which the immune system attacks the body’s own cells and tissues. In 2013, we acquired Immco Diagnostics (“Immco”), an autoimmunity company known for novel assay development and high impact contributions to autoimmune disease diagnostic research. Immco develops, manufactures and sells products in the following formats for diagnosis of autoimmune diseases:
Immunofluorescence Assay (“IFA”);
Enzyme-linked immunosorbent (“ELISA”);
Western Blot (“WB”); and
Line immunoassay (“LIA”).
The Immco product line addresses the lower throughput, specialty autoimmune segment. The principal autoimmune conditions in this segment are Rheumatoid Arthritis, Vasculitis, Lupus, Celiac and Crohn’s Disease, Ulcerative Colitis, Neuropathy, Hashimoto’s Disease and Grave’s Disease.
The Immco products are sold through our sales and marketing organisation to clinical and reference laboratories directly in the United States and via distributors in other countries.
The diagnostic product line is complemented by Immco’s New York State Department of Health licenced reference laboratory offering specialised services in diagnostic immunology, pathology and immunogenetics, and is marketed to U.S.-based reference laboratories and hospitals.
In addition, Immco markets a panel of proprietary early markers for Sjögrens disease often referred to as “dry eye disorder”.
The speciality clinical chemistry business of Trinity Biotech includes reagent products such as ACE, bile acids, oxalate and glucose-6-phosphate dehydrogenase (“G6PDH”) that are clearly differentiated in the marketplace. These products are suitable for both manual and automated testing and have proven performance in the diagnosis of many disease states from liver and kidney disease to G6PDH deficiency which is an indicator of haemolytic anaemia.
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We manufacture enzyme-linked immunosorbent assays, for the detection of syphilis and malaria. These products are sold through distributors and are manufactured under original equipment manufacturer agreements for other major third-party diagnostic companies.
Continuous Glucose Monitoring
In January 2024, we acquired the biosensor and CGM assets of privately held Waveform Technologies, Inc. (“Waveform”). We are currently redeveloping the CGM technology with a view to developing an innovative CGM device and then evolve this platform technology to measure and analyse other valuable biomarkers and related datapoints. Our vision is to develop a portfolio of technologies that can offer users and clinicians valuable actionable health and wellness insights based upon what is happening in, on and around the body.
Waveform, a developer of novel and proprietary new technologies for diabetes care, received a CE Mark for its Cascade CGM in 2019, which was commercially available in Europe. The primary use of the device was to continuously monitor glucose in the human body. The Cascade CGM device and any subsequently developed sensor would be subject to regulatory oversight from the FDA and country specific regulatory authorities and would be subject to the same processes and risks identified in the Government Regulation section of this Annual Report. Glucose in the blood diffuses from capillaries into the liquid between cells known as interstitial fluid. The Waveform CGM device is an electrochemical biosensor which detects the concentration of glucose in interstitial fluid by means of an enzyme immobilised at the surface of a sensor wire inserted into the skin. The action of the enzyme results in the generation of electrical current that is relayed to an attached transmitter where it is converted by a firmware algorithm into a blood glucose concentration. The transmitter then sends this blood glucose measurement to a smartphone or other device where the time within healthy range is tracked and the user alerted to risks of hypo- or hyperglycaemic episodes.
The Waveform CGM technology contains innovative and proprietary aspects with what we believe are important benefits. Significantly, the special composition of the sensor wire and the unique formulation of its protective outer membrane contribute to the ability to achieve needle-free insertion. Needle free insertion has numerous benefits including a reuseable applicator as no needle needs to be safely disposed. This, combined with a reusable transmitter which is also a feature of the acquired CGM technology, allows for two clear benefits. Firstly, it allows for a lower cost of production of the redesigned CGM product compared to the principal current CGM market players and secondly, it reduces the biological waste concerns associated with the currently marketed single-use disposable systems.
Additionally, we believe that this innovative platform technology will allow us to develop a broader suite of wearable biosensors to measure and analyse important health and wellness information. If successful, we intend to target other analytes and data points that represent markers of health and function and make these devices available more broadly around the globe.
The CGM technology acquired from Waveform was developed over many years and Waveform has granted a perpetual, worldwide, non-exclusive license to DexCom, Inc. and its affiliates, for some of the patents acquired by us, but to which we retain the right to use and exploit.
During 2025 and early 2026, our development work on the next‑generation CGM+ platform resulted in further improvements to sensor accuracy, electronics architecture, and the device’s proprietary needle‑free insertion process. These advancements have supported progression toward planned pivotal clinical trials in 2026 and reflect continued refinement of the underlying multimodal biosensor architecture.
Sales and Marketing
We sell our products through our own direct sales force in the United States Our sales team in the United States is responsible for marketing and selling the Trinity Biotech range of point-of-care, infectious diseases, haemoglobins, autoimmune and clinical chemistry products. Meanwhile the direct sales force in Brazil sells the Company’s haemoglobins product range.
Through our international sales and marketing organisation, which is located in Ireland, we sell:
our clinical chemistry product range directly to hospitals and laboratories in Germany and France; and
all product lines through independent distributors and strategic partners in a further approximately 100 countries, with product availability determined by strategic focus and market‑specific factors.
Competition
The diagnostic industry is very competitive. There are many companies, both public and private, engaged in the sale of medical diagnostic products and diagnostics-related research and development, including several well-known pharmaceutical and chemical companies. Competition is based primarily on product reliability, customer service and price. This is a technology driven market with an emphasis on automation and emerging biomarkers. Trinity actively works on increasing automation for the clinical laboratory. Trinity seeks to bring novel biomarkers to market by licensing agreements with universities and innovative companies.
The Group’s competition includes several large companies such as, but not limited to: Abbott Diagnostics, Arkray, Becton Dickenson, Bio-Rad, Copan, Dexcom Inc., Diasorin Inc., Johnson & Johnson, Roche Diagnostics, Sebia, Siemens (from the combined acquisitions of Bayer, Dade-Behring and DPC), Thermo Fisher, Tosoh and Werfen.
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Research and Development
Research and Development (“R&D”) carried out by third parties
Certain R&D activities of the Group are outsourced to third parties as required. These activities are carried out in the normal course of business with these companies. The total amount paid to these R&D consultants and contractors in 2025 was US$2,242,000 (2024: US$ 4,397,000). R&D activities carried out by third parties continued in 2025 as the Company engaged with external consultants regarding the development of our newly acquired CGM biosensor technology.
Research and Products under Development
Trinity Biotech has research and development groups focusing separately on product development in haemoglobins, infectious diseases and as a result of 2024 acquisitions, CGM, prostate cancer and pre-eclampsia. These groups are located in Ireland and the United States In addition to in-house activities, Trinity Biotech sub-contracts some research and development from time to time to independent researchers based in the United States and Europe.
Principal Development Projects
The following table sets forth Trinity Biotech’s main development projects, the costs incurred during each period presented and the cumulative costs (before amortization and impairment) incurred as at December 31, 2025:
Total project costs to December 31,
2025
2024
2025 1
Product Name
US$’000
Premier Instruments for A1c and haemoglobinopathies testing
383
1,542
41,422
4,370
7,040
11,410
PrePsia
1,340
-
Other projects
¹ Cumulative costs to December 31, 2025 is shown before deduction of amortization and impairment losses. Cumulative costs exclude amounts recognised as part of business combinations.
The costs in the preceding table mainly comprise the cost of internal resources, such as the payroll costs for the development teams and attributable overheads. The remainder mainly comprises materials, consumables, regulatory trial and third-party consultant costs.
There are inherent risks and uncertainties associated with completing development projects on schedule. In the experience of Trinity Biotech, the main risks to the achievement of a project’s planned completion date occur primarily during the product’s verification and validation phase. During these phases the product must attain successful results from in-house product testing and from third-party clinical trials. Obtaining regulatory approval on a timely basis is another variable in achieving a project’s planned completion date.
Some aspects of the development of a new product are outside of the control of Trinity Biotech. Notwithstanding the uncertainty surrounding these external factors, Trinity Biotech believes the planned completion dates of these projects are realistic and achievable. As the manufacturing lead time for these new products is relatively short, it is anticipated that material cash inflows will commence shortly after each of the project’s planned completion date.
The following is a description of the principal projects which are currently being undertaken by the research and development groups within Trinity Biotech:
Haemoglobin Development
Premier Hb9210 Instrument for Haemoglobin A1c Testing
A product development plan focused on improvements in our flagship Premier Hb9210 instrument is ongoing. The package of changes aims to expand the target market, reduce instrument downtime and service cost, and significantly expand operating margins.
Our program to develop an improved Diabetes HbA1c column system is now complete. The results of this development program have exceeded expectations, with our new column system now delivering up to four times the number of injections compared to the existing product. We are continuing the commercial launch of these new products.
Premier Resolution Instrument for Haemoglobin Variant Testing
We developed the Premier Resolution instrument which is utilised for haemoglobin variant testing. The instrument achieved 510(k) approval from the FDA in August 2023. The instrument has been sold in certain international markets outside of the United States for many years. Premier Resolution continues to be enhanced with unique features such as lot specific gradients, an optimised internally designed column with extended column life, and a rapidly expanding on-board variant library.
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Point-of-care Development
A combination HIV/Syphilis point-of-care rapid test is also being developed using our existing lateral flow format, we expect this project to restart in 2026.
Continuous Glucose Monitoring Development
In January 2024, we acquired the biosensor and CGM assets of Waveform. We are currently redeveloping the acquired CGM technology. The development work performed to date has focused on improving device performance and usability by refining the sensor design and redesigning the hardware and user workflow. Clinical trials with modified sensors performed in 2025 demonstrated significant improvements in signal quality, sensor accuracy and performance in the clinically important hypoglycemic range.
During 2025 and 2026, further development activities incorporated enhancements to the system’s electronics architecture, resulting in additional improvements in glucose‑measurement accuracy across multi‑day wear. Clinical testing conducted on updated sensor and electronics components contributed more than 650 device‑days of performance data and supported continued refinement of the calibration‑free design.
Development work also expanded the device’s multimodal sensing capability, integrating glucose with selected physiological metrics within a single modular platform. The proprietary needle‑free insertion process was further validated through successful trials performed during this period, supporting the technical viability of the next‑generation device design.
We have hired a number of research and development personnel and have engaged internationally recognised and reputable development consulting organisations to augment our internal CGM development function. The CGM+ programme is advancing through its final design stages, with pivotal clinical trials planned for 2026 as the next major development milestone.
Pre-eclampsia Development
In September 2024, we completed the acquisition of Metabolomics Diagnostics Ltd., an Irish biomarker‑development company focused on early‑pregnancy risk stratification, including its proprietary PrePsia™ preeclampsia‑risk assessment technology. Following acquisition, activities during 2025 were directed exclusively toward the continued development, validation and regulatory preparation of the PrePsia programme.
Our ongoing development work on PrePsia is focused on assay optimisation, refinement of analytical workflows, and preparation for future regulatory submissions. We continue to augment our internal capabilities with specialist scientific and regulatory partners to support these development activities.
Prostate Cancer Test Development
In October 2024, we acquired EpiCapture Limited, an early‑stage molecular diagnostics company developing a non‑invasive urine‑based prognostic test for progression to aggressive prostate cancer. Since acquisition, our development work has focused on data reanalysis, assay streamlining and preparation for two planned clinical studies intended to strengthen the test’s clinical claims. Engagements with several leading US clinical institutions have progressed planning for these studies, and the test is being prepared for future submission to the New York State Department of Health as a laboratory‑developed test.
Patents and Licences
Patents
Due to the significant cost of putting patents in place for our wide range of products, many of our tests are not protected by specific patents. However, we believe that substantially all our tests are protected by proprietary know-how, manufacturing techniques and trade secrets.
As part of the Waveform asset acquisition, we acquired a CGM patent portfolio that includes numerous issued and pending patent applications in the United States and other parts of the world. We believe these patents to be of significant importance in establishing and protecting our proprietary rights in relation to our CGM business. Since the acquisition, there have been 5 granted patents (2 EU and 3 US) and a number of patent applications and provisional patent applications have been filed to protect novel inventions arising from the development programme.
From time-to-time, certain companies have asserted exclusive patent, copyright and other intellectual property rights to technologies that are important to the industry in which we operate. If any of such claims relate to our planned products, we intend to evaluate such claims and, if appropriate, seek a licence to use the protected technology. There can be no assurance that we would be able to obtain licences to use such technology or, obtain such licences on satisfactory commercial terms. If we or our suppliers are unable to obtain or maintain a licence to any such protected technology that might be used in our products, we could be prohibited from marketing such products. We could also incur substantial costs to redesign our products or to defend any legal action taken against us. If our products should be found to infringe protected technology, we could also be required to pay damages to the infringed party.
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Licences
We have entered into a number of licensing arrangements including the following:
Immco entered into a licence agreement on January 19, 2012, and subsequently an amended licence agreement on June 14, 2018. The licence pertains to any product or service relating to identifying indicators of Sjogren’s disease. The agreement is effective through January 21, 2036 and is worldwide in scope. Royalties are payable based on agreement in place.
In 2013, we entered into a licence agreement with a leading market participant, giving us a non-exclusive, worldwide licence to access a significant HIV-2 patent portfolio for the purpose of making, using and selling a HIV test kit, subject to certain limitations.
On December 19, 1999, we obtained a non-exclusive commercial licence from the National Institutes of Health (“NIH”) in the United States for NIH patents relating to the general method of producing HIV-1 in cell culture and methods of serological detection of antibodies to HIV-1.
Each of the licensing arrangements disclosed under this subheading terminates on the date expiration or adjudication of invalidity or unenforceability of the last of the particular licenced patents covered by the respective agreement. Each licensor has the right to terminate the arrangement in the event of our non-performance. The key licensing arrangements, apart from the agreement entered into in 2013 which provides for the payment of a lump sum licence fee, require us to pay a royalty to the licence holder based on sales of the products which utilise the relevant technology being licenced. The total amount paid by us under key licensing arrangements in 2025 was US$112,000 (2024: US$142,000).
We acquired CGM technology from Waveform in January 2024. This technology has been developed over many years and Waveform has granted a perpetual, worldwide, non-exclusive license to Dexcom, Inc. and its affiliates, for some of the patents acquired by us, but to which we retain the right to use and exploit.
Government Regulation
The research, development, preclinical and clinical testing, as well as the manufacture, labelling, marketing, sales, record-keeping, advertising, distribution, and promotion of Trinity Biotech’s products are subject to extensive and rigorous government regulation in the United States and in other countries in which Trinity Biotech’s products are sought to be marketed.
The process of obtaining authorisation to market our products varies, depending on the product categorisation and the country, from merely notifying the authorities of intent to sell, to lengthy formal approval procedures which often require detailed laboratory and clinical testing and other costly and time-consuming processes. The main regulatory bodies which require extensive clinical testing are the FDA in the United States, the Health Products Regulatory Authority (as the authority over Trinity Biotech in Europe), the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom and Health Canada.
The process in each country varies considerably depending on the nature of the test, the perceived risk to the user and patient, the facility at which the test is to be used and other factors. 56% of Trinity Biotech’s 2025 revenues were generated in the Americas (with a large concentration of this in the United States) and as the United States represents a substantial proportion of the worldwide diagnostics market, an overview of FDA regulation has been included below.
Food and Drug Administration
Many of our products sold in the United States are medical devices subject to the Federal Food, Drug, and Cosmetic Act (“FDCA”), as implemented and enforced by the U.S. Food and Drug Administration (“FDA”). Certain products sold in the United States require FDA clearance to market under Section 510(k) of the FDCA. Other products sold in the United States require premarket approval (“PMA”) to market.
Failure by us or by our suppliers to comply with applicable regulatory requirements can result in enforcement action by the FDA or other regulatory authorities, which may result in sanctions including, but not limited to:
untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;
unanticipated expenditures to address or defend such actions;
customer notifications for repair, replacement, refunds;
recall, detention or seizure of our products;
operating restrictions or partial suspension or total shutdown of production;
refusing or delaying our requests for 510(k) clearance or premarket approval of new products or modified products;
operating restrictions;
withdrawing 510(k) clearances or PMA approvals that have already been granted;
restrictions on export or import activities, including refusal to issue certificates required by foreign regulatory authorities; or
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The FDA governs the following activities that we perform or that are performed on our behalf, to ensure that medical products distributed domestically or exported internationally are safe and effective for their intended uses:
product design, development and manufacture;
product safety, testing, labelling and storage;
record keeping procedures;
product marketing, sales and distribution; and
post-marketing surveillance, complaint handling, medical device reporting, reporting of deaths, serious injuries or device malfunctions and repair or recall of products.
FDA premarket clearance and approval requirements
Access to U.S. Market. Each medical device that Trinity Biotech may wish to commercially distribute in the U.S. will require pre-market notification (510(k)) clearance, approval of a pre-market approval (“PMA”) application, or authorization under the De Novo classification process, prior to commercial distribution, unless exempt. Under the FDCA, medical devices are classified into one of three classes -- Class I, Class II or Class III -- depending on the degree of risk associated with each medical device and the extent of control needed to ensure safety and effectiveness.
Class I medical devices are those for which safety and effectiveness can be assured through compliance with the FDA’s general controls, which apply to all medical devices unless specifically exempted. These general controls include adherence to the applicable portions of the FDA’s Quality Management System Regulation (“QMSR”) - which, as of 2026, replaces and modernizes the former Quality System Regulation (QSR) by aligning U.S. requirements with ISO 13485:2016. They also require establishment registration and device listing with the FDA, reporting of adverse events under the Medical Device Reporting (MDR) requirements, and ensuring all labelling, advertising, and promotional materials are appropriate, accurate, and not misleading (collectively, the “General Controls”). Although most Class I devices are exempt from premarket notification, some still require FDA premarket clearance through the 510(k) process, as described below.
Class II devices are subject to FDA’s general controls, and any other special controls as deemed necessary by FDA to ensure the safety and effectiveness of the device. Premarket review and clearance by the FDA for Class II devices is accomplished through the 510(k) premarket notification process. Unless a specific exemption applies, 510(k) premarket notification submissions are subject to user fees.
Devices deemed by the FDA to pose the greatest risk, such as life sustaining, life-supporting or implantable devices, or devices deemed not substantially equivalent to a previously 510(k)-cleared device are categorised as Class III, requiring approval of a PMA.
510(k) Clearance Pathway. When a 510(k) clearance is required, Trinity Biotech must submit a pre-market notification demonstrating that the proposed device is substantially equivalent to a previously cleared 510(k) device, a device that was in commercial distribution before May 28, 1976 for which the FDA has not yet called for the submission of pre-market approval applications, or is a device that has been reclassified from Class III to either Class II or I. By regulation, the FDA is required to clear or deny a 510(k) premarket notification within 90 days of the FDA’s acceptance of the submission for substantive review, excluding periods during which the FDA is awaiting additional information from the applicant. As a practical matter, the FDA’s 510(k) clearance pathway usually takes from 3 to 12 months, but it can take longer, and clearance is never assured. Although many 510(k) pre-market notifications are cleared without clinical data, in some cases, the FDA requires significant clinical data to support substantial equivalence.
In reviewing a pre-market notification, the FDA may request additional information, including clinical data, which may significantly prolong the review process.
After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, requires a new 510(k) clearance or could even require a PMA approval, if the change raises complex or novel scientific issues or the product has a new intended use. The FDA requires each manufacturer to make this determination initially, but the FDA may review any such decision and may disagree with a manufacturer’s determination.
If the FDA disagrees with a manufacturer’s determination, the FDA may require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or pre-market approval is obtained. We have modified aspects of some of our devices since receiving regulatory clearance. Some of those modifications we believe could not significantly affect the safety or effectiveness of the device, and therefore, we believe new 510(k) clearances or pre-market approvals are not required. We have also obtained new 510(k) clearances from the FDA for other modifications to our devices.
In the future, we may make additional modifications to our products after they have received FDA clearance or approval, and in appropriate circumstances, determine that new clearance or approval is unnecessary.
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However, the FDA may disagree with our determination and if the FDA requires us to seek 510(k) clearance or pre-market approval for any modifications to a previously cleared product, we may be required to cease marketing or recall the modified device until we obtain the required clearance or approval. Under these circumstances, we may also be subject to significant regulatory fines or other penalties. In addition, the FDA continues to evaluate the 510(k) process and may make substantial changes to industry requirements, including which devices are eligible for 510(k) clearance, increased scrutiny of predicate devices, reclassification of devices, withdrawal of clearance in limited circumstances, and additional evidentiary requirements that may significantly impact the process.
PMA Approval Pathway. A device that does not qualify for 510(k) clearance generally will be placed in Class III and required to obtain PMA approval, which requires proof of the safety and effectiveness of the device to the FDA’s satisfaction for its intended use. A PMA application must provide extensive technical, preclinical and clinical trial data and also information about the device and its components regarding, among other things, device design, manufacturing and labelling. In addition, an advisory panel made up of clinicians and/or other appropriate experts from outside the FDA is typically convened to evaluate the application and make recommendations to the FDA as to whether the device should be approved.
Although the FDA is not bound by the advisory panel decision, the panel’s recommendation is important to the FDA’s overall decision making process. The PMA approval pathway is more costly, lengthy and uncertain than the 510(k)-clearance process. After a premarket approval application is sufficiently complete, the FDA will accept the application and begin an in-depth review of the submitted information. By statute, the FDA has 180 days to review the “accepted application”, although, generally, review of the application can take between one and three years, but it may take significantly longer. During this review period, the FDA may request additional information or clarification of information already provided. In addition, the FDA will conduct a pre-approval inspection of the manufacturing facility to ensure compliance with Quality System Regulation, which imposes elaborate design development, testing, control, documentation and other quality assurance procedures in the design and manufacturing process.
In February 2022, the FDA proposed an update to the Quality System Regulation (QSR) to align U.S. medical device quality management system requirements with the international standard ISO 13485:2016. In February 2024, the FDA finalized this initiative by issuing the Quality Management System Regulation (the “QMSR”), which amends 21 CFR Part 820 and incorporates by reference ISO 13485:2016 and became effective on February 2, 2026. Under the QMSR, ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes is formally incorporated by reference, making its requirements directly applicable to FDA‑regulated medical devices subject to FDA-specific clarifications. The adoption of the QMSR represents a major step in regulatory convergence and is intended to promote consistency, reduce redundant audits, and streamline compliance for both U.S. and international manufacturers.
After approval of a PMA, a new PMA or PMA supplement is required in the event of a modification to the device for changes affecting safety or effectiveness, its labelling or its manufacturing process. The FDA imposes substantial user fees for the submission and review of PMA applications. The FDA may approve a PMA application with post-approval conditions intended to ensure the safety and effectiveness of the device including, among other things, restrictions on labelling, promotion, sale and distribution and collection of long-term follow-up data from patients in the clinical study that supported approval. Failure to comply with the conditions of approval can result in materially adverse enforcement action, including the loss or withdrawal of the approval. New PMA applications or PMA supplements are required for significant modifications to the manufacturing process, labelling of the product and design of a device that is approved through the PMA process. PMA supplements often require submission of the same type of information as the original PMA application, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA application and may not require as extensive clinical data or the convening of an advisory panel.
Clinical Studies
Devices that have not received FDA approval or clearance and are used in clinical trials are considered to be and must be labelled as investigational devices. The FDA regulates these products under the IDE regulations (In 21 C.F.R. § 812).
Per the IDE regulations, clinical studies that involve investigational devices are divided into two categories, based on the type of device. Studies of devices considered by the agency to present a significant risk require prior approval by an Institutional Review Board (“IRB”), informed consent of patients, and FDA approval of an IDE application, which details in part the clinical study protocol, pursuant to 21 C.F.R. § 812. A “significant risk device” is defined in 21 C.F.R. 812.3(m) as a device that presents a potential for serious risk to the health, safety, or welfare of a subject and falls into at least one of the following categories: (1) it is intended as an implant; (2) it is used in supporting or sustaining human life; (3) it is of substantial importance in diagnosing, curing, mitigating or treating a disease, or otherwise prevents impairment of human health; or (4) it otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. Studies of non-significant risk investigational devices require IRB approval and informed consent; however, the sponsor of the study does not have to obtain FDA approval of an IDE application before beginning the study.
Most clinical studies of IVDs (all of which technically involve investigational use only (“IUO”) devices) are exempted from the IDE regulation, so long as the IUO device and the study meet certain regulatory criteria. Specifically, devices are exempt from IDE requirements if they are intended for IUO and:
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Are non-invasive;
Do not require an invasive sampling procedure that poses a significant risk;
Do not introduce energy into a subject by design or intention;
Are not to be used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure; and
Comply with the labelling requirements for IUO devices, as outlined in 21 C.F.R. § 812.2(c)(3).
If an IUO device does not meet all the requirements for exemption, studies involving that IUO device would be subject to the IDE regulations. The majority of our products are exempt from the IDE regulation. However, we are required to have IRB approval prior to and during our clinical trials and must obtain informed consent from study participants.
Post-market Regulation
After the FDA permits a device to enter commercial distribution, numerous regulatory requirements apply. These include:
product listing and establishment registration, which helps facilitate FDA inspections and other regulatory action;
Quality Management System Regulations (QMSR) which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process;
labelling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label use or indication;
clearance of product modifications that could significantly affect safety or efficacy or that would constitute a major change in intended use of one of our cleared devices;
medical device reporting regulations, which require that manufacturers comply with FDA requirements to report if their device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction of the device or a similar device were to recur;
post-approval restrictions or conditions, including post-approval study commitments;
post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device;
the FDA's recall authority, whereby it can ask, or under certain conditions order, device manufacturers to recall from the market a product that is in violation of governing laws and regulations;
regulations pertaining to voluntary recalls; and
notices of corrections or removals.
We have registered our facilities with the FDA as medical device manufacturers. The FDA has broad post-market and regulatory enforcement powers. We are subject to announced and unannounced inspections by the FDA to determine our compliance with the QMSR and other regulations and these inspections may include the manufacturing facilities of our suppliers.
The Medical Device Single Audit Program (MDSAP) became fully operational in 2017, when the FDA concluded its pilot phase and formally began accepting MDSAP audit reports from authorized Auditing Organizations in place of routine FDA surveillance inspections. Under the MDSAP framework, manufacturers undergo a single, comprehensive audit - conducted annually and paid for by the manufacturer - that evaluates compliance with the regulatory requirements of all participating authorities, including the FDA, Health Canada, Brazil’s ANVISA, Australia’s TGA, and Japan’s MHLW/PMDA. Upon receipt of the MDSAP audit report, the FDA reviews the findings to assess whether the facility remains in a state of control. If the results indicate significant deficiencies, or if the FDA identifies risks that warrant additional oversight, the agency may still conduct its own inspection. When noncompliance is identified, the FDA retains full authority to take enforcement action, which can include issuing a public Warning Letter, imposing fines, initiating injunctions or civil penalties, requesting recalls, seizing products, restricting operations, suspending or halting production, refusing 510(k) submissions or PMA approvals, withdrawing previously granted clearances or approvals, or pursuing criminal prosecution in severe cases.
Advertising and promotion of medical devices are regulated not only by the FDA, but also by the Federal Trade Commission (“FTC”), state regulatory and enforcement authorities, and by non‑U.S. regulatory bodies in the jurisdictions in which our products are marketed. In recent years, promotional activities for FDA‑regulated products by other companies have been the subject of enforcement actions under healthcare reimbursement laws, consumer protection statutes, and other federal and state laws. In addition, under the federal Lanham Act and comparable state laws, competitors and other third parties may initiate litigation challenging advertising and promotional claims.
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If the FDA determines that our promotional materials, sales activities, or training programs constitute promotion of an unapproved or “off‑label” use of a device, the FDA may require us to modify or discontinue such materials or activities and may take regulatory or enforcement action. Such actions could include the issuance of an untitled letter or warning letter, as well as more severe measures such as injunctions, product seizure, civil monetary penalties, or criminal sanctions. Other federal, state, or foreign authorities could also initiate enforcement actions if they determine that our promotional or training materials constitute unlawful promotion, including promotion that results in false or improper claims for reimbursement.
Outside the United States, our promotional and training activities are subject to the laws and regulations of foreign jurisdictions, including, for example, the European Union Medical Device Regulation (“EU MDR”) and In Vitro Diagnostic Regulation (“IVDR”), as well as regulations enforced by national competent authorities and designated bodies. These laws generally impose strict requirements on claims, promotional content, intended use, and consistency with approved or certified labelling. Certain jurisdictions apply particularly stringent rules regarding promotional claims, comparative advertising, and interactions with healthcare professionals.
Failure to comply with U.S. or non‑U.S. advertising and promotion requirements could result in regulatory enforcement actions, product restrictions, suspension or withdrawal of marketing authorizations or certifications, significant fines or penalties, civil liability, or criminal sanctions. Any such actions could harm our reputation, limit our ability to promote our products, delay or prevent product adoption, and adversely affect our business, financial condition, and results of operations. Furthermore, our products could be subject to voluntary recall if we or the FDA determine, for any reason, that our products pose a risk of injury or are otherwise defective. Moreover, the FDA can order a mandatory recall if there is a reasonable probability that our device would cause serious adverse health consequences or death.
Unanticipated changes in existing regulatory requirements or adoption of new requirements could have a material adverse effect on the Group. Any failure to comply with applicable QMSR or other regulatory requirements could have a material adverse effect on the Group’s revenues, earnings and financial standing.
There can be no assurances that the Group will not be required to incur significant costs to comply with laws and regulations in the future or that laws or regulations will not have a material adverse effect upon the Group’s revenues, earnings and financial standing.
Clinical Laboratory Improvement Amendments of 1988 (“CLIA”)
Purchasers of Trinity Biotech’s clinical diagnostic products and our reference laboratory in the United States may be regulated under The Clinical Laboratory Improvements Amendments of 1988 and related federal and state regulations. CLIA is intended to ensure the quality and reliability of clinical laboratories in the United States by mandating specific standards in the areas of personnel qualifications, administration and participation in proficiency testing, patient test management, quality control, quality assurance and inspections. The regulations promulgated under CLIA established three levels of diagnostic tests (“waived”, “moderately complex” and “highly complex”) and the standards applicable to a clinical laboratory depend on the level of the tests it performs. Laboratories performing high complexity testing are required to meet more stringent requirements than laboratories performing less complex tests. In addition, we and our customers are required to meet certain laboratory licensing requirements for states with regulations beyond CLIA. For more information on state licensing requirements, see the sections entitled “Government Regulation – New York Laboratory Licensing” and “Government Regulation – Other States’ Laboratory Licensing.”
Under CLIA, a laboratory is any facility that performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease, or the impairment of or assessment of health.
CLIA requires that a laboratory hold a certificate applicable to the type of laboratory examinations it performs and that it complies with, among other things, standards covering operations, personnel, facilities administration, quality systems and proficiency testing, which are intended to ensure that clinical laboratory testing services are accurate, reliable and timely. Laboratories must register and list their tests with the CMS, the agency that oversees CLIA.
CLIA compliance and certification is also a prerequisite to be eligible to bill for services provided to governmental payor program beneficiaries and for many private payors. CLIA is user-fee funded. Therefore, all costs of administering the program must be covered by regulated facilities, including certification and survey costs.
To maintain our CLIA certification for our New York reference laboratory, we are subject to routine inspections and surveys at least biennially to assess compliance with applicable CLIA requirements. We may also be subject to additional unannounced inspections or focused surveys in response to complaints, quality concerns, or changes in testing activities. CLIA regulations require comprehensive validation of all laboratory‑developed and modified tests used in clinical testing, including establishment and verification of accuracy, precision, analytical specificity and sensitivity, reportable and reference ranges, and other performance characteristics, as applicable.
The regulatory and compliance standards governing the laboratory testing services we provide are subject to change, including through amendments to CLIA regulations, interpretive guidance, or enforcement practices. Compliance with any new or revised requirements could require additional validation activities, quality system enhancements, operational changes, or capital expenditures. Failure to maintain CLIA certification or comply with evolving regulatory requirements could result in sanctions, limitations on testing activities, or other enforcement actions, and could have a material adverse effect on our business, financial condition, and results of operations.
Federal Oversight of Laboratory Developed Tests and Research Use Only Products
Trinity Biotech supplies clinical laboratories with raw materials - such as reagents - that may be incorporated into clinical laboratory tests. These laboratories remain subject to the CLIA, administered by the CMS and applicable state laws governing laboratory operations and testing quality.
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Although the FDA has statutory authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to regulate medical devices, the agency has historically exercised enforcement discretion and generally has not applied device regulations to laboratory developed tests (“LDTs”). The FDA has described LDTs as in vitro diagnostic tests designed, manufactured, and used within a single CLIA‑certified laboratory.
In May 2024, the FDA issued a final rule that sought to classify in vitro diagnostic products (“IVDs”) - including LDTs manufactured by laboratories - as FDA‑regulated medical devices and to phase-out the agency’s long‑standing enforcement discretion policy over a staged, multi-year period.
However, in March 2025, the U.S. District Court for the Eastern District of Texas vacated that rule. The FDA did not appeal and, in September 2025, issued a final rule reverting the definition of IVDs to its pre-2024 form. As a result, the attempted phase‑out will not take effect, and LDTs are currently regulated primarily under CLIA rather than through FDA premarket review or other device requirements. The FDA, however, retains authority to address safety concerns and violations of the FD&C Act, including misbranding and other violations outside traditional LDT oversight boundaries, depending on the facts and circumstances. Future legislation or renewed rulemaking could alter this framework.
Some products are for research use only (“RUO”), or for investigational use only (“IUO”). RUO and IUO products are not intended for human clinical use and must be properly labelled in accordance with FDA guidance. Claims for RUOs and IUOs related to safety, effectiveness, or diagnostic utility or that the product is intended for human clinical diagnostic or prognostic use are prohibited. In November 2013, the FDA issued guidance titled “Distribution of In Vitro Diagnostic Products Labelled for Research Use Only or Investigational Use Only - Guidance for Industry and Food and Drug Administration Staff.” This guidance sets forth the requirements to utilize such designations, labelling requirements and acceptable distribution practices, among other requirements. Mere placement of an RUO or IUO label on an in vitro diagnostic product does not render the device exempt from otherwise applicable clearance, approval or other requirements. The FDA may determine that the device is intended for use in clinical diagnosis based on other evidence, including how the device is marketed.
We cannot predict how future FDA actions regarding LDTs or RUO/IUO products may affect reagents, we may sell or use in the development of assays in our reference laboratory. Changes in legislation, rulemaking, guidance or enforcement policy could impose additional regulatory requirements on LDTs or on reagents used in LDTs and could adversely affect our business.
Product Imports/Exports
Products for export from the United States are subject to foreign countries’ import requirements and the exporting requirements of the FDA, as applicable. In particular, international sales of medical devices manufactured in the United States that are not approved or cleared by the FDA for use in the United States, or are banned or deviate from lawful performance standards, are subject to FDA export requirements.
Foreign countries often require, among other things, an FDA certificate for products for export, also called a Certificate for Foreign Government (“CFG”). To obtain this certificate from the FDA, the device manufacturer must apply to the FDA. The FDA certifies that the product has been granted clearance or approval in the United States and that the manufacturing facilities were in compliance with the QMSR regulations at the time of the last FDA inspection. If the FDA determines that our facilities or procedures do not comply with the QMSR, it may refuse to provide such certificates until we resolve the issues to the FDA’s satisfaction. Failure to obtain a CFG could inhibit our ability to export our products to countries that require such certificates.
Export of products subject to 510(k) notification requirements, but not yet cleared to market, is permitted without FDA export approval, if statutory requirements are met. Unapproved products subject to PMA requirements can be exported to any country without prior FDA approval provided, among other things, they are not contrary to the laws of the destination country, they are manufactured in substantial compliance with the QMSR, and have been granted valid marketing authorisation in Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa or member countries of the European Union or of the European Economic Area (“EEA”). FDA approval must be obtained for exports of unapproved products subject to PMA requirements if these export conditions are not met.
There can be no assurance that Trinity Biotech will meet statutory requirements and/or receive required export approval on a timely basis, if at all, for the marketing of its products outside the United States.
Foreign Corrupt Practices Act and Other Anti-Corruption Laws
We are subject to the U.S. Foreign Corrupt Practices Act (“FCPA”), which prohibits companies and individuals from engaging in bribery and other corrupt practices in dealings with foreign government officials, foreign political parties, and candidates for foreign political office. The FCPA makes it unlawful to corruptly offer, pay, promise to pay, or authorize the giving of anything of value, directly or indirectly, to a foreign official, political party, party official, or candidate for public office for the purpose of obtaining or retaining business or securing any improper business advantage. The FCPA also applies to payments made through third parties, including distributors, agents, consultants, and other intermediaries.
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In addition, the FCPA contains accounting provisions that require us to maintain accurate books and records and to devise and maintain a system of internal accounting controls sufficient to provide reasonable assurances that transactions are executed and assets are accessed and accounted for in accordance with management authorization. Our current and future international operations, including sales outside the United States, subject us to the FCPA and to increased risk of non‑compliance. Failure to comply with the FCPA could result in substantial civil or criminal penalties, disgorgement of profits, enhanced compliance obligations, reputational harm, and other adverse consequences.
Our international operations also subject us to anti‑corruption and anti‑bribery laws outside the United States, including the U.K. Bribery Act 2010 (the “Bribery Act”). The Bribery Act is broader in scope than the FCPA and, among other things, prohibits the offering, promising, or giving of bribes, as well as the requesting, agreeing to receive, or accepting of bribes, in both the public and private sectors. It also creates a strict liability offense for commercial organizations that fail to prevent bribery by employees, agents, or other associated persons, subject to a limited defense for companies that have implemented adequate procedures designed to prevent such conduct.
Companies organized in the United States may be subject to the Bribery Act if they carry on a business or part of a business in the United Kingdom, regardless of where the prohibited conduct occurs. Penalties under the Bribery Act include potentially unlimited fines for companies and criminal liability for individuals, including directors and officers, under certain circumstances. Any failure to comply with the FCPA, the Bribery Act, or similar anti‑corruption laws in other jurisdictions could result in significant fines or penalties, restrictions on our business activities, reputational damage, and a material adverse effect on our business, financial condition, and results of operations.
Healthcare Reform
The Protecting Access to Medicare Act of 2014 (“PAMA”) substantially revised the methodology used by the Centers for Medicare & Medicaid Services (“CMS”) to establish payment rates for clinical diagnostic laboratory tests under the Medicare Clinical Laboratory Fee Schedule (“CLFS”). PAMA requires certain “applicable laboratories” to report private payor payment rates and associated test volumes to CMS. CMS uses this data to calculate Medicare reimbursement rates based on a volume‑weighted median of reported private payor rates.
Since its enactment, implementation of PAMA has been repeatedly delayed, modified, or partially suspended through subsequent legislation, and Congress has intervened multiple times to delay data reporting requirements, adjust applicable data collection periods, and limit annual payment reductions. As a result, Medicare reimbursement rates under the CLFS have not consistently reflected current private market pricing. Most recently, Congress has delayed full implementation of new reporting cycles and limited the magnitude of annual payment reductions, including applying temporary caps and zero‑percent reduction years. Nevertheless, beginning in future payment years, PAMA‑related rate reductions of up to 15% per year may resume, subject to further legislative action. As a result, future Medicare reimbursement levels under the CLFS remain uncertain and could be materially reduced.
In addition to PAMA, other federal healthcare laws enacted in recent years have affected, or may continue to affect, Medicare reimbursement for clinical laboratory services. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “Affordable Care Act”), included provisions that reduced the annual update factor used to adjust CLFS payment rates for inflation and imposed additional productivity adjustments, which together have the effect of constraining or reducing reimbursement over time. The Affordable Care Act also promoted initiatives to revise Medicare payment methodologies, including alternative payment models, bundling of payments, and increased emphasis on quality and efficiency metrics.
The Budget Control Act of 2011 implemented mandatory, across‑the‑board federal spending reductions, including a sequestration mechanism that reduced Medicare payments to providers by 2%. Although sequestration was temporarily suspended or reduced during the COVID‑19 public health emergency, the full 2% Medicare sequestration reduction is currently in effect and, as amended by subsequent legislation, is scheduled to remain in effect through at least fiscal year 2032 unless further congressional action is taken.
In addition, the Middle Class Tax Relief and Job Creation Act of 2012 implemented a one‑time reduction to CLFS payment rates and rebased payments at the reduced level for subsequent years. The American Taxpayer Relief Act of 2012 further expanded the government’s ability to recover overpayments by extending the statute of limitations for Medicare overpayment recovery actions from three to five years.
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Taken together, these statutes and related regulatory actions have resulted in sustained downward pressure on Medicare reimbursement for laboratory testing and increased administrative and reporting obligations. Future legislative or regulatory changes, including further implementation of PAMA, modifications to sequestration, or changes to payment methodologies, could result in additional reductions in Medicare reimbursement, increased compliance costs, or operational burdens. Any such developments could materially adversely affect our revenues, results of operations, and cash flows.
State and Federal Privacy and Security Laws
The federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (collectively, “HIPAA”), and the regulations promulgated thereunder by the U.S. Department of Health and Human Services (“HHS”), establish comprehensive requirements governing the privacy, security, and breach notification of individually identifiable health information, known as protected health information (“PHI”). HIPAA applies to healthcare providers, including clinical laboratories such as our reference laboratory, health plans, and healthcare clearinghouses (collectively, “covered entities”), as well as to certain service providers acting on behalf of covered entities (“business associates”).
HIPAA’s Privacy Rule regulates the use and disclosure of PHI, including limitations on permissible disclosures and requirements for patient rights, such as access, amendment, and accounting of disclosures. HIPAA also establishes standards for electronic healthcare transactions, including the required data content, code sets, and formats for certain administrative and financial transactions, as well as standard identifiers for health plans, healthcare providers, and employers. In addition, individuals (or their personal representatives, as applicable) have the right to access completed laboratory test reports directly from laboratories, and to direct laboratories to transmit copies of such reports to designated persons or entities, subject to certain exceptions.
HIPAA’s Security Rule imposes administrative, physical, and technical safeguards to protect the confidentiality, integrity, and availability of electronic PHI. The HIPAA Breach Notification Rule requires covered entities and business associates to notify affected individuals without unreasonable delay following a breach of unsecured PHI, and to notify HHS’s Office for Civil Rights (“OCR”). In the case of breaches affecting 500 or more individuals in a single jurisdiction, notice to prominent media outlets may also be required. Business associates are directly liable for compliance with applicable HIPAA requirements, and covered entities may also be held liable for violations by their business associates in certain circumstances, including where an agency relationship exists. OCR enforces HIPAA through investigations, compliance reviews, audits, and the imposition of corrective action plans and civil monetary penalties. HIPAA also authorizes state attorneys general to bring civil actions on behalf of state residents for certain HIPAA violations.
In addition to HIPAA, numerous state laws and regulations govern the privacy, confidentiality, and security of health information and other personal information, including state medical privacy laws, consumer data protection statutes, breach notification laws, and cybersecurity requirements. In many cases, these state laws impose requirements that are more stringent than, or differ from, HIPAA, including shorter breach notification timelines, broader definitions of protected data, or enhanced rights for individuals. To the extent these laws apply to our operations or to individuals whose information we process, we may be subject to additional compliance obligations and heightened liability.
We are also subject to other federal privacy and data protection laws outside of HIPAA. For example, the Federal Trade Commission (“FTC”) uses its consumer protection authority to bring enforcement actions against companies for unfair or deceptive acts or practices relating to the collection, use, or disclosure of personal information, including health‑related information that may fall outside HIPAA’s scope. The FTC has also enforced its Health Breach Notification Rule and the Children’s Online Privacy Protection Act (“COPPA”) against companies that fail to comply with applicable requirements. Our handling of personal information is also governed by our published privacy policies, notices, and contractual commitments, which may create additional compliance obligations.
The legal and regulatory landscape governing the privacy and security of health information and other personal information is complex and continues to evolve rapidly at the federal, state, and international levels. New laws, regulations, guidance, and enforcement priorities are regularly introduced, and existing requirements are frequently amended or reinterpreted. We cannot assure that we are, or will remain, fully compliant with all applicable privacy and security requirements in every jurisdiction in which we operate, process personal information, or have patients or customers, or that the cost of compliance with new or changing requirements will not be significant. Any failure or perceived failure to comply with privacy and data security obligations could result in regulatory investigations, enforcement actions, fines, civil litigation, contractual liability, reputational harm, loss of customer trust, and reduced demand for our services, any of which could have a material adverse effect on our business, financial condition, and results of operations.
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Federal and State Anti-Kickback Laws
The federal Anti‑Kickback Statute (“AKS”) makes it a criminal offense for any person or entity, including a clinical laboratory, to knowingly and willfully offer, pay, solicit, or receive any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward the referral of an individual, or the purchasing, leasing, ordering, or arranging for or recommending the purchase, lease, or order, of any item or service for which payment may be made, in whole or in part, under a federal healthcare program, including Medicare and Medicaid. Courts have interpreted the AKS broadly and have held that a violation may occur if even one purpose of the remuneration is to induce referrals or other business reimbursable by a federal healthcare program, regardless of whether the arrangement also serves legitimate business or clinical purposes. A person or entity need not have actual knowledge of the AKS or specific intent to violate the statute to be found liable.
The term “remuneration” is broadly defined and interpreted to include anything of value, such as cash payments, gifts, discounts, rebates, free or below‑market goods or services, equipment or supplies, credit arrangements, waivers of co-payments or other charges, ownership or investment interests, or other forms of financial or non‑financial benefit. As a result, the AKS prohibits many commercial arrangements that would otherwise be lawful in non‑healthcare industries.
Recognizing that the AKS could potentially prohibit benign or beneficial arrangements, the HHS has promulgated a series of regulatory safe harbors that protect certain types of arrangements from enforcement if all applicable requirements are strictly met. Compliance with an applicable safe harbor provides protection from criminal and civil liability under the AKS for the conduct covered by the safe harbor. However, failure to satisfy a safe harbor does not render an arrangement per se unlawful; rather, arrangements that fall outside safe harbors are evaluated based on the totality of the facts and circumstances to determine whether unlawful intent is present.
Penalties for violations of the AKS are severe and may include criminal fines, imprisonment, civil monetary penalties, mandatory exclusion from participation in federal healthcare programs, and the imposition of compliance obligations. Federal and state enforcement authorities actively scrutinize financial and other arrangements between healthcare providers, suppliers, laboratories, and actual or potential referral sources to determine whether such arrangements improperly induce referrals or the ordering or use of particular products or services.
Violations of the AKS may also form the basis for liability under the federal False Claims Act (“FCA”), on the theory that claims submitted in violation of the AKS are false or fraudulent. FCA liability may result in treble damages, substantial statutory penalties on a per‑claim basis, and qui tam actions brought by whistleblowers, in addition to criminal penalties, civil monetary penalties, and exclusion from federal healthcare programs.
Enforcement authorities, courts, and legislators have demonstrated a willingness to look beyond the formal structure or stated intent of an arrangement to assess its practical effect and underlying purpose, including whether compensation or benefits provided to referral sources are consistent with fair market value and commercially reasonable arrangements absent referrals.
In addition to federal law, many states have enacted anti‑kickback, fee‑splitting, self‑referral, or patient brokering laws that are similar to, or broader than, the federal AKS. Some of these state laws apply to healthcare items or services reimbursed by private payors as well as government programs and may impose liability on parties that would not be subject to the federal statute. There can be no assurance that our relationships with physicians, hospitals, clinical laboratories, distributors, or other customers or business partners will not be subject to investigation, challenge, or enforcement under federal or state anti‑kickback or related laws. Any such actions could result in significant penalties, operational restrictions, reputational harm, and adverse effects on our business, financial condition, and results of operations.
Physician Self-Referral Prohibitions
In addition to the AKS, physicians and clinical laboratories are subject to the federal physician self‑referral law, commonly known as the “Stark Law.” The Stark Law generally prohibits physicians from referring Medicare patients for certain designated health services (“DHS”), including clinical laboratory services, to an entity with which the physician, or an immediate family member of the physician, has a financial relationship, unless an applicable statutory or regulatory exception applies. Financial relationships under the Stark Law include both ownership or investment interests and compensation arrangements.
The Stark Law also prohibits the entity furnishing DHS—such as a clinical laboratory—from submitting claims to Medicare (or to Medicaid, in certain circumstances) for services furnished pursuant to a prohibited referral. Claims submitted in violation of the Stark Law are not payable, and any amounts collected for such claims must be refunded. A person or entity may also be subject to civil monetary penalties for entering into or maintaining arrangements or schemes that have the effect of circumventing the Stark Law’s prohibitions.
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The Stark Law is a strict liability statute, meaning that proof of intent is not required to establish a violation. Accordingly, if a physician has a financial relationship with a laboratory and no Stark Law exception applies, referrals by that physician for Medicare‑reimbursable laboratory services are prohibited, regardless of the parties’ intent or whether the arrangement would otherwise be considered reasonable or commercially appropriate. This differs from the Anti‑Kickback Statute, which requires proof of knowing and willful conduct.
The Stark Law includes numerous exceptions that permit certain financial relationships and referral arrangements, provided that all applicable requirements of the exception are fully satisfied. These exceptions are highly technical and prescriptive, and failure to meet even a single condition of an applicable exception will result in prohibited referrals and potential liability. Unlike the Anti‑Kickback Statute’s regulatory safe harbors, Stark Law exceptions are mandatory rather than voluntary; arrangements that do not meet an exception are prohibited by law.
Violations of the Stark Law may result in denial of payment, required refunds of amounts collected, civil monetary penalties, assessments of up to three times the amount claimed, and exclusion from participation in federal healthcare programs. Stark Law violations may also form the basis for liability under the federal False Claims Act if claims arising from prohibited referrals are knowingly submitted for payment.
In addition to federal law, many states have enacted physician self‑referral, fee‑splitting, or similar laws that apply to a broader range of healthcare items and services and may extend beyond Medicare and Medicaid to services reimbursed by private payors or self‑pay patients. Some state laws impose more restrictive requirements or fewer exceptions than the Stark Law. As a result, our relationships with physicians, hospitals, laboratories, and other healthcare providers may be subject to scrutiny or enforcement under both federal and state self‑referral laws. Any violation or alleged violation could result in significant penalties, repayment obligations, reputational harm, and adverse effects on our business, financial condition, and results of operations.
Civil Monetary Penalties Law
The federal Civil Monetary Penalties Law (“CMPL”) authorizes the U.S. Department of Health and Human Services Office of Inspector General (“HHS‑OIG”) to impose civil monetary penalties, assessments, and program exclusion for a wide range of conduct involving federal healthcare programs, including Medicare and Medicaid. Among other things, the CMPL prohibits any person or entity from offering or transferring remuneration, directly or indirectly, to a Medicare or Medicaid beneficiary if the person knows or should know that the remuneration is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of items or services reimbursable by a federal or state healthcare program. “Remuneration” is broadly defined and includes, among other things, cash, gifts, free or discounted items or services, waivers of cost‑sharing obligations, and other items of value, subject to limited statutory exceptions and regulatory safe harbors.
In addition to beneficiary inducements, the CMPL also applies to other forms of prohibited conduct, including the submission of claims for services that are not medically necessary or not provided as claimed, violations relating to inducements to reduce or limit services, and other conduct specified by statute. Violations of the CMPL may result in significant civil monetary penalties assessed on a per‑violation basis, exclusion from participation in federal healthcare programs, and assessments of up to three times the amount claimed or received for the items or services at issue. CMPL enforcement actions may be pursued independently or in conjunction with actions under other federal healthcare fraud and abuse laws, and any such actions could have a material adverse effect on our business, financial condition, and results of operations.
Federal Physician Payment Sunshine Act
The federal Physician Payments Sunshine Act, enacted as part of the Affordable Care Act, and its implementing regulations (collectively, the “Sunshine Act”), require certain manufacturers of drugs, biological products, medical devices, and medical supplies that are covered by Medicare, Medicaid, or the Children’s Health Insurance Program to collect and annually report to the Centers for Medicare & Medicaid Services (“CMS”) information regarding payments or other transfers of value made to U.S. physicians and U.S. teaching hospitals. Reportable transfers of value include, among other things, consulting fees, honoraria, gifts, meals, travel, research funding, grants, charitable contributions, ownership or investment interests, and other items of value, subject to limited exclusions and reporting thresholds. Reported data is published by CMS through its Open Payments program and made publicly available.
Sunshine Act reporting requirements were expanded beginning with the 2021 data collection year to include reporting of payments and other transfers of value made to certain non‑physician healthcare professionals, including physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse‑midwives. As a result, manufacturers subject to the Sunshine Act are now required to track and report a significantly broader set of financial interactions with healthcare professionals.
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Failure to timely, accurately, and completely report required information under the Sunshine Act may result in civil monetary penalties, which may be imposed on a per‑violation basis and are increased for knowing failures to report or for intentional misreporting. In addition to financial penalties, enforcement actions or public reporting inaccuracies may result in reputational harm and increased scrutiny by regulators, healthcare providers, and the public.
In addition to federal requirements, certain states have enacted laws and regulations governing the reporting, disclosure, or restriction of payments and other transfers of value to healthcare professionals and healthcare entities. Some state laws impose marketing restrictions, gift bans, or price transparency obligations, require the adoption of formal compliance programs, or mandate disclosure of payments to a broader range of recipients than required under federal law. These state requirements may differ from, or be more stringent than, the Sunshine Act and may apply regardless of whether the payments are related to products reimbursed by federal healthcare programs.
The need to implement and maintain compliance systems that address varying and evolving federal and state transparency, reporting, and marketing requirements increases the operational burden and the risk of inadvertent or perceived non‑compliance. Any failure to comply with applicable Sunshine Act or state transparency requirements could result in fines, penalties, regulatory scrutiny, reputational harm, and adverse effects on our business, financial condition, and results of operations.
Other Federal and State Fraud and Abuse Laws
In addition to the laws discussed above, our business is subject to a variety of other federal and state healthcare fraud and abuse laws. For example, provisions of the Social Security Act authorize the U.S. Department of Health and Human Services (“HHS”) to exclude from participation in Medicare and Medicaid any entity that submits claims for payment that are substantially in excess of its usual charges for comparable services. The terms “usual charges” and “substantially in excess” are not precisely defined by statute and are subject to interpretation through regulations, guidance, and enforcement actions, creating compliance uncertainty.
HIPAA also established several federal criminal healthcare fraud statutes. These laws prohibit, among other things, knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program, including private third‑party payors, or to obtain money or property owned by, or under the custody or control of, a healthcare benefit program by means of false or fraudulent pretenses, representations, or promises. HIPAA further prohibits knowingly and willfully falsifying, concealing, or covering up a material fact, or making materially false, fictitious, or fraudulent statements or representations, in connection with the delivery of or payment for healthcare benefits, items, or services. As with the Anti‑Kickback Statute, a violation may be established without proof that a person had actual knowledge of the statute itself or specific intent to violate it.
Violations of these healthcare fraud statutes are felonies and may result in substantial criminal fines, imprisonment, civil monetary penalties, and exclusion from participation in federal healthcare programs. Many states have enacted similar healthcare fraud statutes that apply to services reimbursed by both governmental and private payors and that carry significant civil and criminal penalties.
The federal False Claims Act (“FCA”) further prohibits any person from knowingly submitting, or causing to be submitted, false or fraudulent claims for payment to the federal government, making or using false records or statements material to a false or fraudulent claim, or knowingly retaining an overpayment owed to the federal government. Conduct that violates other federal healthcare laws, including the Anti‑Kickback Statute or the Stark Law, may also give rise to liability under the FCA. The FCA’s “qui tam” provisions permit private individuals, known as relators or whistleblowers, to bring actions on behalf of the government. These actions are initially filed under seal, and defendants may not be aware of the existence of such actions for a substantial period of time. If the government or the relator ultimately prevails, the relator may receive a percentage of the recovery.
Violations of the FCA may result in treble damages, substantial civil penalties assessed on a per‑claim basis, exclusion from participation in federal healthcare programs, and, in certain circumstances, criminal sanctions. In addition, many states have adopted comparable false claims statutes, some of which apply to claims submitted to private payors as well as to state healthcare programs.
Finally, the Affordable Care Act (“ACA”) expanded federal enforcement tools and reporting obligations applicable to healthcare manufacturers. Among other things, the ACA imposed federal transparency and reporting requirements on manufacturers of certain drugs, biological products, and medical devices for payments and other transfers of value provided to physicians, teaching hospitals, and certain other healthcare professionals, as well as for ownership and investment interests held by physicians and their immediate family members. These requirements add to the complexity of the regulatory environment in which we operate.
Collectively, these federal and state fraud and abuse laws are complex, often interrelated, and subject to evolving interpretation and enforcement. Any failure, or alleged failure, to comply with these laws could result in significant penalties, repayment obligations, exclusion from government healthcare programs, reputational harm, and adverse effects on our business, financial condition, and results of operations.
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New York Laboratory Licensing
Because our reference laboratory receives specimens originating from New York State, our laboratory is subject to licensure and regulation under New York State laws and regulations administered by the New York State Department of Health, including its Clinical Laboratory Evaluation Program (“CLEP”). New York’s laboratory licensing requirements apply to both in‑state and out‑of‑state laboratories that accept specimens from New York, and they impose some of the most comprehensive and stringent laboratory oversight requirements in the United States.
New York licensure standards govern, among other things:
the day‑to‑day operation and management of a clinical laboratory, including required qualifications, training, and supervision of laboratory personnel;
physical plant, facility, and safety requirements;
laboratory instrumentation, equipment maintenance, and calibration; and
validation, quality control, quality assurance, and record keeping requirements.
New York law also requires laboratories licensed by the state to participate in approved proficiency testing programs for each test performed, regardless of the laboratory’s physical location. In addition, New York generally requires state review and approval of laboratory‑developed tests (“LDTs”) before such tests may be offered to New York residents, which may involve submission of validation data and ongoing compliance obligations.
If a laboratory fails to comply with applicable New York statutory or regulatory requirements, the New York State Department of Health has broad enforcement authority, including the power to suspend, limit, revoke, or annul a laboratory’s license; impose conditions or corrective action requirements; issue citations or censures; and assess civil monetary penalties. Certain violations may also expose the laboratory operator or responsible individuals to criminal liability under New York law, including misdemeanor charges. Any loss, suspension, or limitation of our New York laboratory license, or failure to obtain required approvals for testing, could materially impair our ability to receive specimens from New York and could have an adverse effect on our business. We cannot assure that we will remain in continuous compliance with all applicable New York laboratory requirements at all times.
Other States' Laboratory Licensing
In addition to New York, a number of other states, including California, Florida, Maryland, Pennsylvania, and Rhode Island, require out‑of‑state laboratories to obtain state licensure, registration, or permits under certain circumstances in order to accept specimens originating from those states. These requirements vary by state and may depend on factors such as the type of testing performed, the source of specimens, and whether testing is performed for clinical or diagnostic purposes.
Other states may currently have, or may adopt in the future, similar licensure or registration requirements for out‑of‑state clinical laboratories. State laboratory licensing and regulatory requirements are subject to change and may become more restrictive over time. Failure to obtain or maintain required state licenses, registrations, or approvals could result in enforcement actions, penalties, or restrictions on our ability to perform testing for patients or providers in those jurisdictions, which could adversely affect our business, financial condition, and results of operations.
Regulation outside the United States
The distribution and sale of Trinity Biotech’s products outside the United States are subject to extensive regulation by foreign governmental authorities. Each country has its own regulatory framework governing product approval, clearance, certification, and post‑market oversight, and these requirements vary significantly by jurisdiction. Compliance with foreign regulatory regimes may require substantial time, financial resources, and management attention, and in many cases regulatory approval or authorization must be obtained prior to commercialization.
In addition to product approval requirements, we are subject to foreign regulations governing quality systems, manufacturing, clinical investigations, marketing and promotional practices, vigilance and post‑market surveillance, and interactions with healthcare professionals. In certain jurisdictions, we may also be required to obtain product‑specific approvals, prequalification, or endorsements from local regulatory authorities or international public health organizations, such as the World Health Organization (“WHO”), including WHO Prequalification where required by public sector or donor‑funded procurement programs. Regulatory approval processes and timelines vary widely, and in some jurisdictions may take significantly longer than corresponding U.S. Food and Drug Administration review and clearance processes. As a result, we generally pursue regulatory approvals only in those countries or regions where we believe there is a meaningful commercial opportunity.
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Quality System Standards
Outside the United States, many regulatory authorities require medical device and in vitro diagnostic manufacturers to maintain a certified quality management system. ISO 13485 is the internationally recognized standard for quality management systems applicable to medical devices and in vitro diagnostic products. ISO 13485 certification indicates that a manufacturer’s quality system complies with international standards governing activities across the product lifecycle, including design and development, manufacturing, storage, installation, servicing, and distribution. While ISO certification does not itself constitute regulatory approval, it is often a prerequisite for obtaining product approvals or certifications in many jurisdictions, including the European Union.
European Union – In Vitro Diagnostic Medical Devices
In the European Union (“EU”), in vitro diagnostic medical devices (“IVDs”) are regulated under the In Vitro Diagnostic Medical Device Regulation (Regulation (EU) 2017/746) (“IVDR”), which replaced the former IVD Directive. The IVDR establishes a risk‑based classification system consisting of four classes (Class A, B, C, and D), reflecting increasing levels of risk to patients and public health.
Under the IVDR, most IVDs—including all Class B, C, and D devices—require conformity assessment by an independent conformity assessment body known as a Notified Body before the manufacturer may affix the CE marking and place the product on the EU market. Class A non‑sterile devices may be self‑certified by the manufacturer. The IVDR imposes significantly more stringent requirements than the prior regulatory framework, including expanded requirements for clinical evidence, performance evaluation, post‑market surveillance, vigilance, and traceability. Compliance with the IVDR has increased regulatory complexity, costs, and timelines, and failure to obtain or maintain required certifications could restrict or prevent market access in the EU.
European Union – Medical Devices
Medical devices (other than IVDs) are regulated in the EU under the Medical Device Regulation (Regulation (EU) 2017/745) (“MDR”). The MDR establishes a risk‑based classification system for medical devices and requires manufacturers to demonstrate conformity with applicable general safety and performance requirements. Except for certain low‑risk devices, conformity assessment by a Notified Body is required prior to CE marking. Depending on device classification and risk, manufacturers may be required to submit a design dossier or technical documentation for review and approval, conduct clinical evaluations or investigations, and implement robust post‑market surveillance systems.
Regulatory Requirements Outside the EU
Outside the United States and the European Union, regulatory requirements for medical devices and in vitro diagnostics vary significantly by country and region. Some jurisdictions rely on approvals or certifications from recognized reference regulators, while others require country‑specific product registrations, local clinical data, or in‑country representation. Regulatory frameworks in emerging markets may be less predictable, subject to change, or inconsistently applied. Changes in foreign regulatory requirements, delays in approval processes, or the imposition of new or more stringent standards could adversely affect our ability to commercialize products in those markets.
There can be no assurance that future changes in foreign laws or regulations will not have a material adverse effect on Trinity Biotech’s business, financial condition, or results of operations. There can also be no assurance that we will obtain or maintain foreign regulatory approvals on a timely basis, or at all.
Data Protection and Privacy – European Union
In addition to product regulation, our operations in the EU are subject to the General Data Protection Regulation (“GDPR”), which governs the processing of personal data relating to individuals in the EU. The GDPR establishes strict requirements for lawful, fair, and transparent data processing; purpose limitation; data minimization; accuracy; storage limitation; and data security and confidentiality. It also grants individuals enhanced rights with respect to their personal data, including rights of access, rectification, erasure, restriction of processing, and data portability, and imposes stringent breach notification requirements.
Organizations that fail to comply with the GDPR may be subject to significant administrative fines of up to €20 million or 4% of total worldwide annual turnover, whichever is higher, as well as corrective orders, audits, and reputational harm. Trinity Biotech has appointed a Data Protection Officer (“DPO”) to oversee and coordinate GDPR compliance efforts. However, given the evolving interpretation and enforcement of the GDPR, there can be no assurance that we will not be subject to enforcement actions or penalties related to data protection or privacy compliance.
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Environmental Regulation
The design, development, manufacturing, and distribution of our products may involve the use, storage, handling, and disposal of chemicals and other materials that are potentially hazardous to human health and the environment. As a result, our operations are subject to a wide range of environmental, health, and safety laws and regulations at the international, federal, state, and local levels in the jurisdictions in which we operate or conduct business. These laws and regulations govern, among other things, chemical management, emissions to air and water, waste generation and disposal, worker safety, accident prevention, and remediation of contamination.
In the United States, our operations are subject to environmental laws and regulations administered primarily by the U.S. Environmental Protection Agency (“EPA”) and corresponding state and local authorities. These include, among others, the Toxic Substances Control Act (“TSCA”), which regulates the manufacture, importation, processing, distribution, use, and disposal of chemical substances, and the Pollution Prevention Act, which promotes source reduction and environmentally sound practices. Additional federal and state laws may apply to hazardous waste handling, storage, transportation, and disposal, as well as to releases of regulated substances.
In the European Union (“EU”), environmental protection is a core policy objective reflected in Articles 11 and 191 through 193 of the Treaty on the Functioning of the European Union (“TFEU”). EU environmental regulation includes a comprehensive framework governing chemicals, waste, emissions, and environmental management. In particular, the Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (“REACH”) is the primary EU legislation governing chemical substances and is designed to protect human health and the environment from risks arising from chemicals. REACH imposes extensive obligations on manufacturers and importers of substances, including registration, risk assessment, supply‑chain communication, and, in some cases, authorization or restriction of certain substances. Other EU laws, such as those governing waste electrical and electronic equipment, hazardous waste, industrial emissions, and packaging and recycling, may also apply to our operations.
Failure to comply with applicable environmental laws and regulations could result in a range of enforcement actions, including fines, penalties, injunctions, remediation obligations, restrictions on operations, suspension or revocation of permits, and potential civil or criminal liability. In addition, environmental non‑compliance or incidents could lead to adverse publicity, reputational harm, and increased scrutiny from regulators and other stakeholders, which could adversely affect our business, financial condition, and results of operations.
Our facility in Bray, Ireland, is certified to ISO 14001, the internationally recognized standard for environmental management systems (“EMS”). ISO 14001 certification indicates that a facility has implemented a structured framework for identifying and managing environmental risks, ensuring compliance with applicable environmental legal requirements, improving resource efficiency, managing waste, and monitoring and enhancing environmental performance on a continual basis. We use our EMS to mitigate environmental risk, reduce our environmental footprint, and support compliance with applicable environmental laws and regulations. However, ISO certification does not eliminate the risk of non‑compliance or assure that future changes in environmental laws or enforcement practices will not impose additional costs or operational constraints.
Environmental laws and regulations continue to evolve globally, often becoming more stringent and more complex over time. Changes in environmental standards, regulatory interpretations, enforcement priorities, or sustainability expectations could require us to make additional capital investments, modify manufacturing processes, or incur increased operating and compliance costs. There can be no assurance that future environmental requirements will not have a material adverse effect on our business, financial condition, or results of operations.
Please refer to Note 32 to our audited consolidated financial statements (“Group Undertakings”) included elsewhere in this Annual Report for a listing of our significant subsidiaries, including name, country of incorporation, and proportion of ownership interest.
Our headquarters, manufacturing and research and development facilities, as well as our sales offices, are located in Bray, Ireland. We have entered into a number of related‑party transactions with JRJ Investments (“JRJ”), a partnership owned by Mr Ronan O’Caoimh, a director of the Company, and a former director, Dr Jim Walsh who resigned in September 2025, as well as directly with Mr O’Caoimh, to provide premises in Bray, Ireland
We entered into an agreement for a 25-year lease with JRJ effective from December 2003 for 15,780 square feet of offices at an annual rent of €381,000 (US$448,000).
In 2007, we entered into a 25-year lease agreement with JRJ for a 43,860 square foot manufacturing facility in Bray, Ireland with an annual rent of €787,000 (US$925,000). Subsequent to the signing of this lease, the ownership of the building transferred from JRJ to Mr O’Caoimh solely. A rent review for this property became effective 1 July 2022 and, following an independent valuation, the annual rent increased to €1,050,000 (US$1,234,000)., with backdated rent accruing from that date. Included within overhead costs in cost of sales in 2024 is an amount of $659,000 in respect of backdated rent.
In 2016, we entered into a 10-year lease with Mr. O’Caoimh for a warehouse adjacent to our leased manufacturing facility in Bray, Ireland. The warehouse is 16,000 square feet with an annual rent of €144,000 (US$169,000). A rent review for this property became effective 1 July 2021 and, following an independent valuation, the annual rent increased to €170,560 (US$200,400), with backdated rent accruing from that date. Included within overhead costs in cost of sales in 2024 is an amount of $93,000 in respect of backdated rent. The lease concludes in July 2026 and we intend to exit the premises at that time.
Independent valuers advised the Group that the rent in respect of each of the leases represented a fair market rent.
See Item 7 – Major Shareholders and Related Party Transactions.
We have six main manufacturing sites worldwide, five in the Americas (Buffalo and Jamestown, NY, Kansas City, MO, Wilsonville, OR and Extrema, Brazil), and one in Bray, Ireland. An additional facility is owned in Burlington, Canada which serves as a distribution centre and also carries out some research and development activities.
The U.S. and Irish facilities are each FDA registered and ISO certified facilities. As part of our ongoing commitment to quality, each Trinity Biotech facility was granted the latest ISO 13485 certification. This certification was granted by internationally recognised Notified Bodies. This serves as external verification that Trinity Biotech has established an effective quality system in accordance with an internationally recognised standard. By having an established quality system there is a presumption that we will consistently manufacture products in a controlled manner. To achieve this certification, each Trinity Biotech facility performed an extensive review of the existing quality system and implemented any additional regulatory requirements.
The facilities at Jamestown, NY, Kansas City, MO and Bray, Ireland also achieved certification to the requirements of the Medical Device Single Audit Programme (MDSAP). The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. International regulatory authorities that are participating in the MDSAP include, US Food and Drug Administration, Therapeutic Goods Administration of Australia, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency, The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are Official Observers.
Trinity Biotech, Inc. operates from a 25,610 square foot FDA registered facility in Jamestown, New York. The facility was purchased in 1994. Additional warehousing space is rented in Jamestown, New York at an annual rental charge of US$221,000. This lease has recently been renewed effective 1 July 2025 for five (5) additional one-year rental periods.
TRIB Biosensors Inc. operates from a 26,000 square foot facility in Wilsonville, Oregon. We took over the lease for this facility in January 2024 as part of the Waveform transaction. The lease term was extended to December 2027 with an annual rent of US$363,000.
Primus Corp. operates from two leased facilities in Kansas. One facility comprises 39,000 square feet under a lease with Livers. We have issued a 12‑month termination notice on this lease, and it will cease on January 6, 2027. The current annual rent is US$237,252. The second facility comprises 13,500 square feet, used mainly for warehousing, and is leased until March 31, 2027 with annual rent of US$66,000.
Immco operates from a 31,731 square foot facility in Buffalo, New York. The lease for the site expires in 2034. The annual rent for the facility is US$428,000. An additional 5,120 square foot facility is owned by Trinity Biotech in Burlington, Canada.
Trinity Biotech Brazil operates from office, factory space and warehouse which are leased in Sao Paulo, Brazil and Extrema, Brazil. The leases on these properties have an annual cost of US$18,000, US$58,000 and US$75,000 respectively.
As part of the acquisition of Metabolomics Diagnostics Ltd, we acquired a lease for 2,300 square foot of office space in Cork, Ireland. The annual rent is US$21,600. This lease expired in 2023 and is currently rented on a rolling month-to-month basis.
At present, we have sufficient productive capacity to cover demand for our product range. We continue to review our level of capacity in the context of future revenue forecasts. In the event that these forecasts indicate capacity constraints, we will either obtain new facilities, expand our existing facilities or outsource operations.
The following are the facilities where the Group currently manufactures products:
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Bray, Ireland - Point-of-Care/HIV and Clinical Chemistry products were manufactured at this site during 2024. During 2025, the site continued to perform certain manufacturing processes related to HIV products, while significant aspects of the manufacturing process for these HIV products were transferred to a contract manufacturing partner in Q2 2025 and Q3 2025 following receipt of regulatory clearances. Clinical Chemistry products continue to be manufactured in Bray. In 2025, certain manufacturing processes related to haemoglobin products began at this site.
Jamestown, New York - this site specializes in the production of Microtitre Plate EIA products for infectious diseases and auto-immunity. Viral Transport Media products are also manufactured at this facility. In Q1 2025, in line with our consolidation strategy. significant aspects of the Group’s autoimmune test kits manufacturing operations were transferred from the Buffalo site to Jamestown.
Kansas City, Missouri - this site is responsible for the manufacture of the Group’s haemoglobin range of products and all haemoglobin R&D activities. During 2024 and early 2025, significant aspects of these manufacturing processes were transitioned to other Group manufacturing sites, in line with our strategy to consolidate operations and reduce complexity across our manufacturing footprint.
Buffalo, New York - this site operates as the Group’s reference laboratory. This site previously manufactured autoimmune test kits along with its reference laboratory business. In early 2025, consistent with our strategic focus on operational consolidation, significant aspects of the manufacturing processes were transitioned to other Group sites.
Extrema, Brazil - this site is responsible for the manufacture of certain haemoglobin products sold in Brazil. During 2025, the site also commenced certain haemoglobin manufacturing processes for the Group’s global markets, as production previously undertaken in Kansas City was transitioned to other facilities.
We are in material compliance with all environmental legislation, regulations and rules applicable in each jurisdiction in which we operate.
Principal Capital Expenditure and Divestitures
Our principal capital expenditure in the last three financial years has been on developing new products internally. The amount capitalized for development projects has been US$6.1 million, US$8.6 million, US$1.8 million, for years ended December 31, 2025, 2024 and 2023 respectively. In 2026, we expect the capital expenditure on development projects will be in the range US$15 million to US$25 million, primarily driven by the advancement of our CGM and biosensor technologies and the advancement of a screening test for preeclampsia risk.
Not applicable
Item 5.
We are a commercial stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors. We develop, acquire, manufacture and market diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market and has recently entered the wearable biosensor industry, with the acquisition of the biosensor assets of Waveform Technologies Inc. and intend to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring product. Our products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. We sell our products directly in the United States and Brazil and to an extent in the United Kingdom, Germany and France and through a network of international distributors and strategic partners in approximately 100 countries worldwide. This discussion covers the three years ended December 31, 2025 and should be read in conjunction with the consolidated financial statements and notes thereto appearing elsewhere in this Form 20-F. The financial statements have been prepared in accordance with IFRS both as issued by the International Accounting Standards Board (“IASB”) and as subsequently adopted by the European Union (“EU”) (together “IFRS”). Consolidated financial statements are required by Irish law to comply with IFRS as adopted by the EU which differ in certain respects from IFRS as issued by the IASB. These differences predominantly relate to the timing of adoption of new standards by the EU. However, as none of the differences are relevant in the context of Trinity Biotech, the consolidated financial statements for the periods presented comply with IFRS both as issued by the IASB and as adopted by the EU.
Trinity Biotech is a foreign private issuer and our financial statements have been prepared in accordance with IFRS as issued by the IASB.
Factors affecting our results
The global healthcare market is growing due to, among other reasons, lifestyle changes, the growing incidences of diabetes and other autoimmune and infectious diseases and as a consequence there is an increasing demand for rapid and continuous monitoring tests in a clinical and consumer environment.
Our revenues are directly related to our ability to identify significant revenue-generating products, carry out the necessary development work and to bring them to market quickly and effectively. Efficient and productive research and development is crucial in this environment as we, like our competitors, search for effective and cost-efficient solutions to diagnostic problems. The growth in new technology will almost certainly have a fundamental effect on the diagnostics industry as a whole and upon our future development.
The comparability of our financial results for the years ended December 31, 2025 and 2024 were impacted by impairment losses as a result of impairment reviews during the years ended December 31, 2025 and 2024 (See Item 18, Note 12) and also as a result of transformation costs and other once-off / exceptional costs (see Note 5) incurred in 2024 and 2025.
For further information about the Group’s principal products, principal markets and competition please refer to Item 4, “Information on the Company”.
Going Concern
The accompanying consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates the realization of assets and the discharge of liabilities in the normal course of business for the foreseeable future.
As reflected in the accompanying consolidated financial statements, for the years ended December 31, 2025 and 2024, the Group recorded a loss of US$37.4 million and a loss of US$31.8 million, respectively. For the year ended December 31, 2025 we reported cash outflows of US$0.1 million compared to cash inflows of US$1.7 million for 2024. As of December 31, 2025, we had net current liabilities of US$105.3 million but had an accumulated deficit in equity attributable to the equity holders of the Company of US$72.0 million.
We have made significant progress on a multi‑year transformation plan aimed at improving profitability and simplifying our operating model. During 2024 and 2025, the Group substantially executed this programme, including the consolidation and outsourcing of global manufacturing operations, the closure of underutilised facilities, the transition of production to third‑party manufacturing partners, the relocation of selected business support functions to lower‑cost jurisdictions, and a reduction in overall headcount. These actions have materially reduced the Group’s fixed cost base and simplified its operational footprint, and the majority of the related transformation activities were completed during 2025. As a result, the Group has entered 2026 with a leaner operating model and a materially lower underlying cost structure. In addition, the Group retains further levers to manage liquidity if required, including the ability to defer, phase or reprioritise discretionary research and development expenditure.
Management has prepared detailed cash flow forecasts covering a period of at least 12 months from the year end date. These forecasts incorporate the Group’s current operating performance, committed cost reduction measures, known financing arrangements and include assumptions regarding the availability of additional equity financing consistent with the Group’s recent capital raising activities and disclosures.
The Group continues to benefit from strong support from Perceptive, its principal lender. Under the current credit agreement, the contractual maturity of the Term Loan is January 15, 2027, and there are no scheduled principal repayments prior to this date. On April 30, 2026, the Group entered into a third amendment to the Credit Agreement with Perceptive which provided for an additional US$2.5 million term loan borrowing and limited waivers in respect of certain financial covenants. In February 2026, Perceptive agreed that 50% of the cash interest due would be paid as PIK interest, and in March 2026 and April 2026, Perceptive agreed that 100% of the cash interest due would be paid as PIK interest. These arrangements have been reflected in management’s cash flow forecasts.
The Group breached the minimum revenue covenant under the facility for the quarter ended December 31, 2025. The covenant breach primarily reflected timing‑related variability in HIV revenues, including the timing of the scale‑up of the Group’s outsourced and offshored manufacturing model. These factors affected the timing of shipments and revenue recognition between reporting periods, rather than indicating a deterioration in underlying demand. As part of the third amendment, Perceptive provided a waiver in respect of this breach. In addition, the Group received specific waivers and deferrals in respect of compliance with certain financial covenants applicable to covenant measurement periods occurring after year‑end. In forming its going concern assessment, management has considered the contractual terms of the facility as amended, including the agreed waivers and deferrals. Management’s cash flow forecasts, which incorporate the terms of the Credit Agreement as amended, demonstrate that the Group is able to meet its obligations under the Perceptive facility throughout the going concern review period, including compliance with the amended financial covenants. The forecasts also assume a reduction in debt service obligations through the partial equitisation of the Perceptive Term Loan during the forecast period. Under the Credit Agreement, the Group is required to maintain a minimum unrestricted cash balance of US$3.0 million from July 1, 2026. Based on the forecasts, management remains confident in the Group’s ability to meet its obligations under the Perceptive facility throughout the going concern review period
The Group’s going concern forecasts also include the assumption of equity funding, primarily through the issuance of ordinary shares under existing capital raising arrangements. Such funding is expected to support ongoing operations and continued investment in the Group’s CGM development program. While equity funding is subject to market conditions, the Group has an established track record of raising capital and maintains active engagement with investors.
In preparing these forecasts, management has taken into account the discretionary nature of certain expenditure, including investment in the Group’s CGM development programme, and has assumed that the timing and phasing of such expenditure will be aligned with available funding. Management therefore retains the ability to preserve liquidity, if required, while continuing to execute its strategic priorities without compromising covenant compliance.
The directors have considered the Group’s current financial position and cash flow projections, taking into account all known events and developments, including the ongoing support of its principal lender and the availability of equity funding. Based on this assessment, the directors believe that the Group has adequate resources to continue in operational existence for at least 12 months from the year end date, and that it is appropriate to continue to prepare the consolidated financial statements on a going concern basis.
Impact of Currency Fluctuation
Trinity Biotech’s revenue and expenses are affected by fluctuations in currency exchange rates especially the exchange rate between the US Dollar and the Euro, the Brazilian Real and Canadian Dollar. Trinity Biotech’s revenues are primarily denominated in US Dollars and its expenses are incurred principally in US Dollars, Euro and Brazilian Real. The weakening of the US Dollar could have an adverse impact on future profitability.
Trinity Biotech holds most of its cash assets in US Dollars. As Trinity Biotech reports in US Dollars, fluctuations in exchange rates do not result in exchange differences on these cash assets. Fluctuations in the exchange rate between the Euro or Brazilian Real and the US Dollar may impact on the Group’s Euro or Real monetary assets and liabilities and on Euro, Swedish Krona or Real expenses and consequently the Group’s earnings.
Year ended December 31, 2025 compared to the year ended December 31, 2024
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Strategic Repositioning and Transformation
During 2025, Trinity Biotech undertook a significant strategic repositioning of the Company, reflecting both structural changes in global healthcare markets and the Board and management’s assessment of the long‑term opportunities created by advances in sensor technology, artificial intelligence (“AI”) and digitally delivered healthcare.
This repositioning was executed alongside a multi-initiative comprehensive transformation of the Company’s existing diagnostics business, designed to materially improve financial performance, operational efficiency and capital discipline.
These actions were taken during a period of considerable external disruption, most notably a contraction and reprioritization of international funding for global health programs, including HIV‑focused initiatives, which materially impacted demand for certain of the Company’s legacy product lines during 2025. While this disruption affected near‑term revenues and operating performance, the Company believes these funding dynamics have since begun to stabilize, with demand showing clear signs of recovery entering 2026.
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In addition, changes in international trade and tariff practices caused further disruption and uncertainty across supply chains with an increase in operating costs. Management expects that given the current geopolitical environment, continued changes in this area should be expected. As such management continues to actively monitor the environment and has sought to restructure its supply chain and manufacturing locations so as to provide additional optionality with a view to mitigating the current and potential future impact of such changes, where commercially feasible.
Strategic Pivot Toward Digitally Delivered, AI‑Driven Healthcare
A central element of the Company’s 2025 repositioning was the continued development of its CGM+ program, which represents a strategic pivot beyond traditional in‑vitro diagnostics toward digitally enabled, AI‑driven healthcare solutions. CGM+ is being developed as an integrated continuous glucose monitoring and multimodal biosensing platform intended to support a broader metabolic intelligence offering, rather than a standalone hardware product.
Management believes that long‑term value creation in metabolic health will increasingly be driven by the ability to generate longitudinal, real‑world physiological data and translate that data into clinically actionable insights using AI and advanced analytics. The CGM+ program is designed to serve as a foundational layer within this ecosystem.
While CGM+ remains under development and has not yet been commercialized, the Company believes this strategy positions it to address emerging opportunities at the intersection of diabetes care, cardiometabolic disease and personalized medicine.
Transformation of the Existing Diagnostics Business
In parallel with the CGM+ development effort, Trinity Biotech significantly progressed its comprehensive transformation program for its existing diagnostics operations during 2025. This program is designed to address historical operating inefficiencies, improve cost structure and cash flow generation and reposition the legacy business to sustainably support investment in future growth initiatives.
Management views this transformation not as a short‑term cost‑reduction exercise, but as a structural reset aimed at delivering a step change in financial performance, including improved margins, reduced earnings volatility, and enhanced capital efficiency. In conjunction with this comprehensive transformation plan, the company continues to work with Barclay’s on its previously announced strategic review to examine the most appropriate opportunities for its existing business lines in terms of the company’s medium to long term strategic plan, product life-cycle stages, demand profile and capital structure optimization.
External Disruption and Market Environment
The strategic and operational changes undertaken in 2025 occurred against a backdrop of significant upheaval in the international funding landscape for global health programs. Funding disruptions and delays affecting major multilateral and government‑supported HIV initiatives led to reduced and deferred purchasing activity across parts of the diagnostics sector, including certain markets served by us, most notably rapid HIV products.
These conditions negatively impacted revenue and operating results in specific product categories during 2025, with resultant management decisions around cash-flow optimization having further implications for other parts of the business. However, management believes these effects were primarily driven by funding timing and reprioritization rather than underlying demand fundamentals. In the latter part of 2025 and entering 2026, the Company has observed improving ordering patterns and engagement from customers and partners, suggesting that funding flows and demand are beginning to normalize, albeit with increased levels of order timing and payment variability.
Management Perspective
Management believes that the actions taken in 2025 represent a deliberate and necessary repositioning of Trinity Biotech for the next phase of its evolution. While these initiatives involved near‑term disruption and execution risk, they were undertaken with the objective of aligning the Company with long‑term trends in digital health, AI‑enabled care, and value‑based healthcare delivery, while simultaneously strengthening the financial foundation of the core diagnostics business and providing strengthened opportunities for capital structure optimization to support further company evolution and position the company for long-term growth in a healthcare environment that is set to be further dominated by digital solutions underpinned by an increased need for data.
The Company will continue to evaluate its capital allocation, capital structure, investment pace and operational priorities as CGM+ advances through development.
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Revenues – continuing operations
Our revenues from continuing operations for the year ended December 31, 2025 were US$43.8 million compared to revenues of US$61.6 million for the year ended December 31, 2024, which represents a decrease of US$17.8 million or 28.9%.
The following table sets forth selected sales data for each of the periods indicated.
Year ended December 31,
% Change
Clinical laboratory goods
31,678
39,372
(19.5)
%
Clinical laboratory services
4,006
4,750
(15.7)
Point-of-Care
8,101
17,433
(53.5)
43,785
61,555
(28.9)
Clinical Laboratory Goods
Clinical Laboratory goods revenues decreased by US$7.7 million in 2025, which represents a decrease of 19.5%, primarily due to lower haemoglobin and infectious diseases product revenues.
Haemoglobin revenues fell from US$20.1 million in 2024 to US$16.9 million in 2025, partly due to deferred manufacturing during the transition of certain production processes out of our Kansas City facility as part of our comprehensive transformation plan. While production normalised under a new operating model and sales improved later in the year, full‑year revenues remained below the prior year. In addition, the Company is moving away from its relationship with one of its larger distributors with sales to that distributor falling during 2025, with expected further reductions in 2026. The Company has increased its sales and marketing resources in this area and is actively pursuing new distributor relationships that are more aligned with the Company’s strategic plans for its haemoglobin business.
We are now well positioned to capitalise on a more efficient, higher‑capacity manufacturing base for future growth, particularly in the diabetes care HbA1c testing sector. With rising global diabetes prevalence, we plan to continue investing in working capital to support the expansion of our haemoglobin laboratory systems business, including HbA1c systems. In parallel, we have introduced a new high‑capacity HbA1c column system in the U.S. and select international markets, designed to improve testing throughput and operational efficiency. We have also implemented strategic modifications to our instrumentation supply chain focused on cost reduction, improved reliability and lower service expenses, which we expect will support margin improvement and sustainable long‑term growth.
Infectious disease product revenues decreased from US$5.6 million in 2024 to US$3.8 million in 2025, primarily reflecting lower sales volumes in certain international markets. The largest fall in revenue was from a legacy international customer from which the company derived particularly low margins. The Company is focused on reducing complexity and focusing on higher margin business.
Clinical Laboratory Services
Our New York reference laboratory offers laboratory-testing services for autoimmune disorders, such as Sjogren’s syndrome, hearing loss, celiac disease, lupus, rheumatoid arthritis and systemic sclerosis. Revenues for the laboratory decreased by 15.7% to US$4.0 million. The decrease was mainly attributable to reduced testing volumes for Sjögren’s syndrome. As part of our comprehensive transformation plan we have made changes to the operating structure supporting this service with a view to improving efficiency and increasing testing capacity over time. We believe these actions position this business to grow profitably as volumes recover.
Point-of-Care revenues decreased by 53.5% from US$17.4 million in 2024 to US$8.1 million in 2025. The first half of 2025 was impacted by considerable uncertainty regarding demand for our rapid HIV point‑of‑care products stemming from the U.S. President’s Executive Order on Reevaluating and Realigning United States Foreign Aid, issued in January 2025, which instituted a pause, subject to certain exemptions, on new funding obligations for foreign assistance programmes. As U.S. Government funding supports certain HIV testing programmes that utilise our rapid HIV tests, this development affected both the timing and volume of product sales in the period. In response to this uncertainty, management minimised production of rapid HIV tests during the first half of 2025 to mitigate the risk of obsolete inventory and excess working capital, resulting in a decline in point‑of‑care revenues compared to the prior year. Point‑of‑care revenues in 2024 benefited from higher rapid HIV sales volumes throughout the year.
Production of our Uni‑Gold HIV products recommenced in late Q2 2025, and we experienced a strengthening in sales during the second half of the year as manufacturing under the revised operating model ramped up and demand for rapid HIV tests began to normalise. In addition, manufacturing and commercial supply of our TrinScreen HIV product resumed in the second half of 2025 following the transition of production to an outsourced and offshored manufacturing model. While there was clear evidence of renewed market demand and improved operating performance in the second half of 2025, full‑year point‑of‑care revenues remained below the prior year, reflecting the significant impact of the first‑half disruption. In addition, the Company experienced a temporary revenue impact in Q4 2025 resulting from fine-tuning of manufacturing and supply-chain processes to accommodate the rise in demand for TrinScreen HIV. These processes have been successfully scaled up in early 2026. The business continues to experience some uncertainty regarding the timing of orders and comparatively longer payment cycles as a result of changes in market and funder processes.
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Revenues by Geographical Region
The following table sets forth selected sales data, analysed by geographic region, based on location of customer:
Revenues for continuing operations
Americas
24,624
29,917
(17.7)
Asia/Africa
15,383
24,775
(37.9)
Europe
3,778
6,863
(45.0)
Total
In the Americas, revenues decreased US$5.3 million or 17.7%. The decrease was primarily driven by lower sales in our haemoglobin business, reflecting deferred manufacturing during the transition of certain production processes out of our Kansas City facility. In addition, revenues from our clinical laboratory services declined, reflecting lower autoimmune testing volumes.
In Asia/Africa, revenues decreased by 37.9%, or US$9.4 million compared to 2024. The decline was mainly attributable to lower sales of our rapid HIV point‑of‑care products, reflecting the impact of funding‑related demand uncertainty in key African markets during the first half of the year and modest reductions in revenues from our haemoglobin and infectious disease product lines within the Asia region.
In Europe, revenues decreased by US$3.1 million, or 45.0% compared to 2024. The reduction was primarily driven by lower haemoglobin product revenues.
Cost of sales, gross profit and gross margin
Total cost of sales decreased by US$13.2 million from US$40.1 million for the year ended December 31, 2024 to US$26.9 million, for the year ended December 31, 2025, a decrease of 32.9%. This resulted in a gross profit for 2025 of US$16.9 million compared to a gross profit for December 31, 2024 of US$21.4 million. The gross margin of 38.6% in 2025 compares to a gross margin of 34.8% in 2024. The increase in gross margin in 2025 reflects the continued execution of the Group’s Comprehensive Business Transformation Plan, with benefits from manufacturing consolidation, offshore production and improved operating efficiency under the new cost base. In addition, certain stranded costs incurred during the transition period were reclassified from cost of sales to selling, general and administrative expenses, contributing to the year‑on‑year improvement in gross margin.
Stranded costs represent costs that are no longer directly attributable to ongoing operations or revenue‑generating activities following organisational changes, restructuring, site closures, or product rationalisation. Such costs typically include overheads, personnel costs and facility‑related expenses that cannot be avoided or redeployed in the short term. Stranded costs are assessed each reporting period and are recognised in profit or loss as incurred, unless they relate directly to a qualifying asset or meet the criteria for capitalisation under relevant accounting standards.
Other operating (expense)/income
Other operating income was US$1.9 million for the year ended December 31, 2025, compared to other operating expense of US$1.8 million for the year ended December 31, 2024. The movement primarily reflects a fair value gain of US$1.9 million recognised in 2025 in respect of the remeasurement of contingent consideration associated with the Waveform CGM acquisition, following its incorporation into the amended Perceptive term loan facility. There was no comparable gain in the prior year.
The expense of US$1.8 million in 2024 related primarily to the reversal of US$1.8 million income from loan forgiveness of second-round Paycheck Protection Program (PPP) loans received by certain U.S. subsidiaries recognised in 2020. The settlement of second‑round Paycheck Protection Program (“PPP”) loans during 2025 did not give rise to additional other operating income, with the agreed settlement amounts reflected within finance costs and once‑off costs. For further details, see Notes 4, 5 and 6.
Research and development expenses
Research and development expenses decreased from US$4.5 million for the year ended December 31, 2024 to US$3.6 million for the year ended December 31, 2025, a decrease of 20.1%.
Selling, general and administrative expenses
Selling, general and administrative expenses decreased for the year ended December 31, 2025 by US$4.1 million to US$24.7 million when compared to the year ended December 31, 2024, representing a decrease of 14.4%. A significant element of the US$4.1 million decrease relates to:
i) a US$3.1 million decrease in salaries and related personnel costs, reflecting the impact of organisational realignment measures undertaken as part of the transformation program.
ii) lower non-cash share-based payments expense of US$324,000 (US$1,316,000 in 2024) mainly due to forfeitures and expirations.
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Impairment charges
Impairment charges increased from US$1.4 million for the year ended December 31, 2024 to US$2.2 million for the year ended December 31, 2025. There are a number of factors taken into account in calculating the impairment, including the Company’s period-end share price, calculation of the cost of capital, and future projected cash flows for individual cash-generating units in the business. In addition, the Group examines individual development project assets for indicators of impairment.
The Company evaluated the value in use of each of its cash-generating units, which is defined as the present value of expected future cash flows. Where this value in use was determined to be less than the carrying amount of the respective unit's assets, excluding inventories, trade and other receivables, cash and cash equivalents, and deferred tax assets, an impairment was recognised.
Premier Resolution is a capitalised intangible asset held within Primus Corporation and relates to the Resolution platform for haemoglobinopathy and variant testing in the US market. While the platform has achieved technical feasibility and obtained FDA clearance in late 2023, the commercialisation pathway is dependent on securing adoption within a highly concentrated US reference laboratory market.
While the Group continues to pursue commercial opportunities for the platform and believes that it retains underlying potential, these factors have resulted in the recoverable amount of the asset being lower than its carrying value. Accordingly, the Group recognised a partial impairment charge of US$2.1 million during the year.
Immco Diagnostics’s value in use was below the value of its relevant assets, and an impairment was provided for as at December 31, 2025 (US$20,000).
Clark Laboratories Inc’s value in use was below the value of its relevant assets, and an impairment was provided for as at June 30, 2025 (US$28,000) and as at December 31, 2025 (US$2,000).
The impairment charges for the year ended December 31, 2024 related to impairment losses identified for four cash generating units, namely Biopool US Inc. (US$0.2 million), Immco Diagnostics Inc (US$0.1 million) Clark Laboratories Inc (US$0.1 million) and Trinity Biotech Do Brasil (US$0.2 million). For further details, see Item 18, Notes 11, 12, and 13.
Transformation Costs
As part of a strategic initiative to enhance operational efficiency and align the Group’s cost base with its long‑term objectives, the Group has been executing a comprehensive business transformation programme, which was substantially progressed during the year ended December 31, 2025. The programme comprises targeted actions to improve operational profitability, streamline the organisational structure and consolidate manufacturing and support functions under a more efficient operating model.
As a result, we incurred transformation costs of US$4.3 million during 2025 (2024: US$4.2 million), which were primarily related to personnel-related expenses, outsourcing of selected functions, site transfers, stock-related adjustments and transition‑related manufacturing inefficiencies. These costs are presented separately within Selling, General and Administrative expenses.
The largest component comprised costs of approximately US$3.3 million representing fixed manufacturing overheads that were not absorbed into cost of sales due to lower throughput at certain manufacturing sites during and following the consolidation and outsourcing of elements of the Group’s manufacturing operations under the Comprehensive Transformation Plan. These costs arose as the Group transitioned away from legacy manufacturing locations and reconfigured its manufacturing footprint, resulting in a temporary mismatch between fixed cost capacity and production volumes. As manufacturing consolidation and outsourcing activities progress towards completion, and production volumes are stabilised under the new operating model, the Group expects a significant reduction in such stranded costs, although residual transformation‑related costs may continue into 2026 as the programme reaches its final phases.
While the majority of the transformation activities were undertaken during 2025, the Group expects to incur further limited, residual transformation‑related costs during 2026 as the final phases of the programme are executed. The overall level of transformation costs is expected to reduce as the programme enters its final stages. The transformation is intended to deliver a lower and more flexible cost base, supporting improved profitability and long‑term financial performance. For further details, see Item 18, Note 5 “Impairment, transformation and once‑off costs”.
Once-Off Costs
During the year ended December 31, 2025, the Group recognised a gain of US$0.2 million (2024: loss of US$1.9 million) within operating expenses relating to a legacy, non‑trading matter. The gain recognised in 2025 arose from the reversal of a provision previously recorded following settlement of the matter during the year. The loss recognised in 2024 related primarily to the initial recognition of the provision associated with this matter. These amounts do not relate to the Group’s ongoing operations and are not expected to recur.
Operating Loss
Operating loss for the year ended December 31, 2025 was US$15.8 million, compared to an operating loss of US$21.2 million in the year ended December 31, 2024. The reduced loss was mainly attributable to increased gross margins and lower indirect costs.
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Operating Loss excluding Impairment, Transformation & Once-off costs
Operating loss excluding Impairment, Transformation & Once-off costs for the year ended December 31, 2025 was US$9.5 million, compared to US$13.7 million for the year ended December 31, 2024, reflecting the improvement in gross margins, savings in indirect costs and increased impairment costs.
Financial expenses
Financial expenses in the year ended December 31, 2025 were US$21.3 million compared to US$9.6 million in the year ended December 31, 2024, an increase of US$11.7 million, broken down as follows:
Year ended December 31, 2025
Year ended December 31, 2024
US$m
Interest on senior secured term loan
12.3
8.6
Interest on convertible note
1.2
Lease interest
0.6
Interest payable on repayment of PPP loans
(0.2)
0.3
Capitalised borrowing costs
(2.9)
(2.1)
Loss on extinguishment of old loan balance
10.0
Other non-cash financial expense
1.0
21.3
9.6
Note: table above contains rounded numbers
The increase of US$11.7 million in financial expenses in 2025 compared to 2024 was driven primarily by the US$10.0 million loss on extinguishment of the old senior secured term loan, recognised in connection with the refinancing of the Group’s debt during the year (see Note 23). The loss on extinguishment arose principally from the termination of a contingent feature under the prior loan agreement, pursuant to which the Group had exposure of up to US$15.0 million linked to a partnership trigger; this was settled as part of the refinancing through the incorporation of US$7.5 million, into the new senior secured term loan.
In addition, interest expense on the senior secured term loan increased due to a higher average outstanding loan balance during 2025. These increases were partially offset by gains arising from the fair value remeasurement of embedded derivatives.
Interest on the senior secured term loan, comprising both cash and non‑cash interest, increased from US$8.6 million in 2024 to US$12.3 million in 2025, mainly reflecting the higher term loan balance during the year. Interest on the convertible note, comprising cash and non‑cash interest, remained unchanged at US$1.2 million in both 2024 and 2025.
During 2025, the Group capitalised borrowing costs of US$2.9 million into development assets, compared to US$2.1 million in 2024, in accordance with its accounting policy.
In October 2024, the Company became aware of a U.S. governmental review relating to second‑round Paycheck Protection Program (“PPP”) loans received by certain U.S. subsidiaries. As at December 31, 2024, estimated interest of US$0.3 million was accrued in respect of the related payable (see Note 4 for further details).
A settlement was reached during 2025 with respect to the PPP loans, a reversal of previously accrued interest of approximately US$0.2 million was recognised within financial expenses.
Income tax (expense)/credit
The Company recorded a tax expense on continuing operations of US$199,288 for the year ended December 31, 2025 compared to a tax credit of US$486,000 for the year ended December 31, 2024. The 2025 tax credit consists of approximately US$465,000 of current tax charge and US$266,000 of a deferred tax credit. The 2024 tax credit consists of approximately US$285,000 of current tax charge and US$299,000 of a deferred tax credit. For further details on the Group’s tax charge please refer to Item 18, Note 7 and Note 14 to the consolidated financial statements.
Loss before tax from continuing operations
The loss before tax for continuing operations for the year ended December 31, 2025 was US$37.4 million, in comparison to US$31.2 million for the year ended December 31, 2024.
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Profit/(Loss) from discontinued operations
In 2024, discontinued operations comprised Fitzgerald Industries, which was divested in April 2023, and the discontinued cardiac point‑of‑care business on the Meritas platform. Profit for the period from discontinued operations totalled US$12.9 million, largely attributable to a gain of US$12.7 million on the divestiture of Fitzgerald Industries. The gain comprised gross proceeds of approximately US$30.0 million, offset by transaction costs of US$1.3 million and the derecognition of net assets disposed of amounting to US$16.3 million.
Following negotiations, a settlement agreement relating to post‑completion claims arising from the sale of Fitzgerald Industries was finalised prior to December 31, 2024 and subsequently signed in January 2025. Under the terms of the settlement, the Company agreed to pay Biosynth US$150,000 in full and final settlement of all claims. During 2025, the Company paid US$75,000 with the remaining US$75,000 included in accrued liabilities in the consolidated financial statements as at December 31, 2025. The settlement fully resolves all disputes related to the sale of Fitzgerald Industries, and no further liabilities are expected to arise.
There were no discontinued operations in 2025.
Year ended December 31, 2024 compared to the year ended December 31, 2023
Our revenues from continuing operations for the year ended December 31, 2024 were US$61.6 million compared to revenues of US$56.8 million for the year ended December 31, 2023, which represents an increase of US$4.7 million or 8.3%.
The increase is mainly due to sales of our HIV screening test, TrinScreen HIV of US$10.0 million for the year offset by decreases in our clinical laboratory sales and sales in legacy haemoglobinopathies product.
2023
42,288
(6.9)
5,453
(12.9)
9,091
91.8
56,832
8.3
Clinical Laboratory goods revenues decreased by US$2.9 million in 2024, which represents decreased of 6.9%. The movement is driven by decreases within our haemoglobin business, our COVID-19 VTM products and our Infectious Diseases products.
Sales in our haemoglobin business declined by US$1.1 million (5.2%) due primarily to the continued downward trend in revenues for our legacy haemoglobinopathies product, the Ultra II instrument. Our replacement for the Ultra II instrument, the Premier Resolution, obtained FDA approval in August 2023.
There was a decrease of US$0.4 million in sales for our COVID-19 VTM products as public health PCR testing programs for COVID-19 have largely been discontinued. We have retained the capability to flex manufacture volumes should market conditions warrant it.
Sales in our Infectious Diseases products have decreased by US$0.7 million which was primarily driven by two larger customers changing infectious disease technology platform.
Our New York reference laboratory offers laboratory-testing services for autoimmune disorders, such as Sjogren’s syndrome, hearing loss, celiac disease, lupus, rheumatoid arthritis and systemic sclerosis. Revenues for the laboratory decreased by 12.9.% to US$4.8 million, due primarily to a reduction in transplant related testing volumes in full year 2024 compared to full year 2023. The laboratory had provided transplant testing services to a local healthcare provider for a number of years, however in early 2023 that healthcare provider informed us that it was moving to a different service provider and this resulted in lost revenues for the laboratory beginning in the second quarter of 2023.
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Point-of-Care revenues increased by 91.8% from US$9.1 million in 2023 to US$17.4 million in 2024. Sales of our HIV screening test, TrinScreen HIV were US$10.0 million for the year (US$0.4 million in 2023) as we continued to see strong demand following our initial shipments in late 2023. This was partially offset by a decrease of 14.3% in other Point-of-Care revenues, primarily driven by decreased sales in our UniGold HIV range, primarily as a result of testing disruptions in two key markets, which we expect are temporary disruptions.
32,282
(7.3)
18,909
31.0
5,641
21.7
In the Americas, revenues decreased US$2.4 million or 7.3%, primarily driven by lower sales in our haemoglobin business in Brazil, a full-year impact of reduced volumes in our New York reference laboratory, and a decline in demand for our COVID-19 VTM products. Sales in Brazil declined by US$0.8 million due to reduced demand for our legacy haemoglobinopathies instrument. Revenues from the New York laboratory declined by US$0.7 million, reflecting the full-year impact of the loss of transplant testing volumes beginning in the second quarter of 2023. In addition, COVID-19 VTM sales declined in the region as public health PCR testing programs continued to wind down.
In Asia/Africa, revenues increased by 31.0%, or US$5.9 million compared to 2023. The increase was primarily driven by strong growth in sales of our TrinScreen HIV screening test. TrinScreen continued to gain traction following its launch in late 2023, with significant uptake across key African markets. This increase was partially offset by a decline in sales of our UniGold HIV product range in Africa and modest reductions in revenues from our haemoglobin and infectious disease product lines within the Asia region
In Europe, revenues increased by US$1.2 million, or 21.7% compared to 2023. The by higher demand from our main European distributor for haemoglobin products. This growth reflects stronger ordering within Western Europe year. The increase was supported by growth in our clinical chemistry product line across the region.
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Total cost of sales increased by US$2.7 million from US$37.4 million for the year ended December 31, 2023 to US$40.1 million, for the year ended December 31, 2024, an increase of 7.3%. This resulted in a gross profit for 2024 of US$21.4 million compared to a gross profit for 2023 of US$19.5 million. The gross margin of 34.8% in 2024 compares to a gross margin of 34.2% in 2023.
Other operating income decreased from US$0.1 million for the year ended December 31, 2023 to negative US$1.79 million for the year ended December 31, 2024. This is due to the reversal of $1.8 million income from loan forgiveness of second-round Paycheck Protection Program (PPP) loans received by certain U.S. subsidiaries recognised in 2020. For further details, see Note 4.
The other operating income for 2024 relates to a transition services agreement with the acquirer of Fitzgerald Industries.
Research and development expenses increased from US$4.4 million for the year ended December 31, 2023 to US$4.5 million for the year ended December 31, 2024, an increase of 3.7% mainly due to lower capitalisation of payroll costs into product development intangible assets.
Selling, general and administrative expenses decreased for the year ended December 31, 2024 by US$2.3 million to US$28.8 million when compared to the year ended December 31, 2023, representing an decrease of 7.5%. A significant element of the US$2.3 million decrease relates to:
i) a US$1.9 million decrease in salaries and related personnel costs, reflecting the impact of organisational realignment measures undertaken as part of the transformation program.
ii) lower non-cash share-based payments expense of US$0.8 million mainly due to forfeitures and expirations.
Impairment charges decreased from US$11.1 million for the year ended December 31, 2023 to US$1.4 million for the year ended December 31, 2024. There are a number of factors taken into account in calculating the impairment, including the Company’s period-end share price, calculation of the cost of capital, and future projected cash flows for individual cash-generating units in the business. In addition, the Group examines individual development project assets for indicators of impairment.
Biopool US Inc’s value in use was below the value of its relevant assets, and an impairment was provided for as at June 30, 2024 (US$0.1 million) and as at December 31, 2024 (US$0.2 million).
Immco Diagnostics’s value in use was below the value of its relevant assets, and an impairment was provided for as at June 30, 2024 (US$0.1 million) and as at December 31, 2024 (US$0.1 million).
Clark Laboratories Inc’s value in use was below the value of its relevant assets, and an impairment was provided for as at June 30, 2024 (US$0.1 million) and as at December 31, 2024 (US$0.1 million).
Trinity Biotech do Brasil’s value in use was below the value of its relevant assets, and an impairment was provided for as at June 30, 2024 (US$0.2 million) and as at December 31, 2024 (US$0.2 million).
During the year the Company reassessed the carrying value of its current development projects. Specific impairments were recognized in respect of two projects totaling US$1.6 million.
During 2023, the Company fully impaired its investment in imaware, comprising US$0.7 million paid and US$0.8 million accrued but unpaid, under a total committed investment of $1.5 million. In 2024, the Company reversed US$0.8 million of the previously recognised impairment through profit or loss, corresponding to the accrued balance that was no longer payable under the terms of the investment agreement.
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The impairment charges for the year ended December 31, 2023 related to impairment losses identified for two cash generating units, namely Immco Diagnostics Inc (US$10.8 million) and Trinity Biotech Do Brasil (US$0.3 million. For further details, see Item 18, Notes 11, 12, and 13.
As part of a strategic initiative to enhance operational efficiency and align the Group’s structure with its long-term objectives, we undertook a comprehensive business transformation during the year ended December 31, 2024. This program involved targeted measures aimed at improving operational profitability, streamlining our organizational structure, and consolidating certain business unit activities.
As a result, we incurred transformation costs of US$4.2 million during 2024 (2023: US$nil), which were primarily related to personnel-related expenses, outsourcing of selected functions, site transfers, and stock-related adjustments. These costs are presented separately within Selling, General and Administrative expenses and are not expected to recur.
The transformation activities are intended to deliver long-term cost savings and operational benefits, supporting the Group’s strategy of focusing on core areas of growth and enhancing overall financial performance. For further details, see Item 18, Note 5 ‘Impairment, transformation and once off costs’.
During the year ended December 31, 2024, the Group incurred exceptional, non-trading costs totaling US$1.9 million (2023: US$nil). These costs were not related to the Group’s ongoing operations and are not expected to recur.
Included within this amount was a charge of US$1.1 million relating to a non-refundable retainer fee paid to a corporate finance advisor in connection with a planned future equity raise, settled through the issuance of 650,000 American Depositary Shares (“ADSs”).
Operating loss for the year ended December 31, 2024 was US$21.2 million, compared to an operating loss of US$27.0 million in the year ended December 31, 2023. The lower loss was mainly attributable to increased revenues and gross margins, lower impairment charges and lower indirect costs, partly offset by transformation costs and once off costs.
Operating loss excluding Impairment, Transformation & Once-off costs for the year ended December 31, 2024 was US$13.7 million, compared to US$15.9 million for the year ended December 31, 2023, reflecting the improvement in gross margins and the savings in indirect costs.
Financial expenses in the year ended December 31, 2024 were US$9.6 million compared to US$11.1 million in the year ended December 31, 2023, a decrease of US$1.5 million, broken down as follows:
Year ended December 31, 2023
8.5
1.1
Penalty for early partial settlement of term loan
0.9
Loss on disposal of exchangeable notes
0.0
Interest on exchangeable notes
11.1
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The decrease of US$1.5 million in 2024 compared to 2023 is due to capitalization of borrowing costs and non-reoccurrence of early payment penalties, partially offset by costs associated with fair value remeasurement of embedded derivatives.
Interest on the senior secured term loan, comprising cash and non-cash interest, increased from US$8.5 million in 2023 to US$ 8.6 million for 2024 mainly due to a higher term loan balance. Interest on the convertible note, comprising cash and non-cash interest, increased from US$1.1 million in 2023 to US$1.2 million in 2024. An early repayment penalty of US$0.9 million was incurred in Q2, 2023 because of an early partial settlement of the term loan of US$10.1 million. During 2024, we capitalized borrowing costs totaling US$2.1 million into development costs (2023: US$nil). There was a net expense of US$1.0 million relating primarily to the fair value remeasurement of embedded derivatives.
In October 2024, the Company became aware of a U.S. governmental review relating to second‑round Paycheck Protection Program (“PPP”) loans received by certain U.S. subsidiaries. At year-end, estimated interest of US$0.3 million was recorded in respect of the payable (see note 4 for further details).
Financial income
Financial income for the year ended December 31, 2024 was US$nil million compared to US$1.2 million for the year ended December 31, 2023. In 2023, the financial income related to a fair value adjustment for the derivative liability related to warrants granted to the Group’s principal lender.
The Company recorded a tax expense on continuing operations of US$486,000 for the year ended December 31, 2024 compared to a tax credit of US$59,000 for the year ended December 31, 2023. The 2024 tax credit consists of approximately US$285,000 of current tax charge and US$299,000 of a deferred tax credit. The 2023 tax credit consists of approximately US$264,000 of current tax credit and US$323,000 of a deferred tax credit. For further details on the Group’s tax charge please refer to Item 18, Note 7 and Note 14 to the consolidated financial statements.
The loss before tax for continuing operations for the year ended December 31, 2024 was US$31.2 million, in comparison to US$36.9 million for the year ended December 31, 2023.
Profit from discontinued operations
The discontinued operations comprise Fitzgerald Industries which was divested in April 2023 and the discontinued cardiac point-of-care business on the Meritas platform. Profit for the period from discontinued operations totalled US$12.9 million, largely attributable to the gain of US$12.7 million on the divesture of Fitzgerald Industries. The gain comprises proceeds of approximately US$30 million offset by transaction costs of US$1.3 million with net assets eliminated on disposal of US$16.3 million.
Following negotiations, a settlement agreement was finalised prior to December 31, 2024 and subsequently signed in January 2025. Under the terms of the settlement, the Company agreed to pay Biosynth US$150,000 in full and final settlement of all post-completion claims. Accordingly, a provision of US$150,000 has been recorded in the consolidated financial statements as at December 31, 2024, see Note 22. The settlement fully resolves all disputes related to the sale of Fitzgerald Industries, and no further liabilities are expected to arise.
For further details, see Item 18, Note 8.
The Group’s capital structure is a mixture of debt and equity. In February 2023, we amended and restated our senior secured term loan credit facility with Perceptive to allow for an immediate US$5 million increase to the outstanding term loan. In April 2023, we closed the sale of our Fitzgerald Industries life sciences supply business, for cash proceeds of approximately US$30 million subject to customary adjustments. We used approximately US$11 million of those proceeds to repay approximately US$10.1 million of principal under the credit agreement and we incurred an approximately US$0.9 million early repayment penalty. In January 2024, we entered into a further amendment to the Perceptive credit facility, to, among other things, provide additional capital to fund the acquisition of the Waveform continuous glucose monitoring (CGM) assets.
During 2024 and 2025, we entered into a series of further amendments to the Perceptive credit facility that provided incremental term loan funding, extended maturities, and permitted additional interest payments to be paid‑in‑kind. In connection with these amendments, Perceptive received new warrants to purchase 2.25 million ADSs, in aggregate. These steps reflect our ongoing strategy to secure funding for strategic growth initiatives while actively managing our capital structure.
In December 2025, these arrangements were restructured into a new senior convertible note, materially modifying the form, maturity profile and potential settlement mechanics of our indebtedness to Perceptive.
Term loan with Perceptive
In December 2021, we entered into a US$81.3 million senior secured term loan credit facility with Perceptive. The term loan was drawn down in January 2022. The loan was originally due to mature in January 2026, however this has since been amended. The loan initially accrued interest at an annual rate equal to 11.25% plus the greater of (a) one-month LIBOR (later changed to the Term SOFR Reference Rate effective from October 28, 2022) and (b) one percent per annum, and interest is payable monthly in arrears in cash. The term loan does not require any amortization, and the entire unpaid balance will be payable upon maturity. The term loan can be repaid, in part or in full, at a premium before the end of the four-year term.
In connection with the term loan, we agreed to issue warrants to Perceptive for 500,000 of our ADSs. The per ADS exercise price of the Warrants was US$6.50 (subsequently amended in 2023 and again in 2024). The warrants are exercisable, in whole or part, until the seventh anniversary of the date of drawdown of the funding under the term loan.
The Company made an early partial settlement of the term loan of US$34.5 million in May 2022 and in accordance with the term loan’s credit agreement, there was an early repayment penalty of US$3.45 million. In February 2023, we amended and restated senior secured term loan credit facility to allow for an immediate US$5 million increase to the outstanding Term Loan. On April 27, 2023, we used approximately US$11 million of the proceeds of the sale of Fitzgerald Industries to repay approximately US$10.1 million of principal plus an approximately US$0.9 million early repayment penalty.
In January 2024, we closed the acquisition of the Waveform CGM assets and liabilities and in connection with that acquisition, we drew down additional funding from Perceptive of US$22 million under an amended Credit Agreement. The amended Credit Agreement also provided for a further US$6.5 term loan borrowing, which was fully drawn-down in April 2024.
The amended agreement also immediately reduced the annual rate of interest on the loan by 2.5% to 8.75% (the “Applicable Margin”) plus the greater of (a) Term Secured Overnight Financing Rate (SOFR) or (b) 4.0% per annum, and allowed for a further 2.5% reduction in the Applicable Margin to 6.25% once the outstanding principal under the Amended Term Loan falls below US$35 million. Additionally, the early repayment penalty was reduced from a range of 8% to 7% to 4.0% to 3.5%, dependent on timing of early repayment, and reduces the revenue covenants.
On December 23, 2024 we entered into the third amendment and restatement of the credit agreement governing the Term Loan. As part of this agreement, an additional US$2.0 million of funding was made available to us. We also agreed that certain interest payments payable in 2024 and 2025 would be paid-in-kind on the applicable payment date by increasing the outstanding principal amount of the Term Loan. Additional warrants were also provided that allow an additional 1,500,000 ADSs to be purchased (2.5 million ADSs in total) at $0.80 per ADS. This amendment to the term loan also saw the repricing of the existing warrants to an exercise price of US$0.80 per ADS.
On February 27, 2025, we entered into the fourth amended and restated credit agreement, which provided for an additional US$4.0 million increase to our outstanding Term Loan.
On May 14th, 2025, we entered into a fifth amended and restated credit agreement, which provided for an additional US$2.0 million in term loan funding, extended the maturity date of the Term Loan to July 27, 2026, and provided that interest payments for the months of April, May, and June 2025 will be paid-in-kind.
On August 7, 2025, we entered into a sixth amended and restated credit agreement, which provided for a further US$2.0 million in funding, extended the maturity date of the Term Loan by a further three months to October 1, 2026, and provided that interest payments for the months of July and August 2025 would be paid-in-kind. Additional warrants were also provided that allow an additional 750,000 ADSs to be purchased at US$0.86 per ADS.
On October 16, 2025, the Company entered into a sixth amended and restated credit agreement, which provided for a further US$2.0 million in funding, and provided that interest payments for the months of September and October 2025 would be paid-in-kind.
On December 22, 2025, we entered into a series of agreements, including a Second Amendment to the Sixth Amended and Restated Credit Agreement, under which our existing term loan obligations to Perceptive were restructured into a new senior convertible note in the principal amount of approximately US$93.3 million. This restructuring modified the terms, maturity profile and potential settlement mechanics of our indebtedness to Perceptive. Under these agreements, Perceptive may elect, at its discretion, to convert up to US$60.0 million of its term loan obligations, and $12.5 million of certain other obligations, into ADSs. The timing, volume and frequency of any conversions are entirely at Perceptive’s election, and the Company has no control over whether, when, or to what extent such conversions may occur. The Second Amendment also provided for an additional US$5.0 million in term loan borrowing, extended the maturity date of the Term Loan to January 15, 2027 and allowed for a further 3.5% reduction in the Applicable Margin to 5.25%, once the outstanding principal amount of the term loans falls below US$50.0 million. See the description in Item 10.C. Material Contracts, under the headings “—Credit Agreement and Senior Convertible Note” and “—Conversion Rights Agreement”.
The outstanding amount owing for the term loan at December 31, 2025 is US$108.0 million.
Under the Amended Term loan, we are subject to a number of covenants and obligations.
Subsequent to December 31, 2025, the Company received a waiver from Perceptive in respect of a compliance breach of the minimum revenue covenant for the twelve month period ended December 31, 2025. The covenant breach primarily reflected timing‑related variability in HIV revenues, including the timing of the scale‑up of the Group’s outsourced and offshored manufacturing model. These factors affected the timing of shipments and revenue recognition between reporting periods, rather than indicating a deterioration in underlying demand. Although this waiver was granted subsequent to the reporting date, the Company was not in compliance with this covenant as at December 31, 2025.
In addition, subsequent to year end the Company obtained waivers of the minimum revenue covenant applicable to quarterly measurement periods through July 1, 2026. The Company also received waivers in respect of the minimum liquidity covenant for the measurement periods ended March 31, 2026 and April 30, 2026. The scheduled increase in the minimum liquidity threshold was also deferred until July 1, 2026. Each of these waivers and the liquidity covenant deferral relates to covenant measurement periods occurring after December 31, 2025.
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Notwithstanding the waivers obtained subsequent to the reporting period, the senior secured term loan is classified as a current liability in the consolidated statement of financial position as at December 31, 2025. In accordance with IAS 1.69(d) and IAS 1.74, when a covenant breach exists at the reporting date and a waiver is obtained only after that date, the entity does not have an unconditional right to defer settlement of the liability for at least twelve months as at the reporting date. The waivers described above do not amend the contractual maturity of the Company’s senior secured term loan, which remains January 15, 2027.
On April 30, 2026, the Group entered into a third amendment to its Credit Agreement with Perceptive and a related amendment and restatement of the Senior Convertible Note. The amendment to the Credit Agreement provided for, among other things, an additional US$2.5 million term loan borrowing, the payment of certain interest through April 2026 as PIK interest, and a limited waiver of certain financial covenants. In connection with these amendments, the aggregate principal amount of indebtedness subject to conversion was increased from US$60.0 million to US$72.5 million. Under the amended and restated Senior Convertible Note, up to US$72.5 million of the aggregate principal amount of the Convertible Note is convertible, at the holder’s election, into ADSs, at a conversion price of 97% of the VWAP of the ADSs at the time of each such conversion, subject to the minimum conversion price of $0.5061 (equal to 75% of the 30 day VWAP of the Company’s ADSs for the period ended April 22, 2026). This amended conversion price also applies to amounts convertible pursuant to the Conversion Rights Agreement. All conversions remain subject to the beneficial ownership limitations and other terms and conditions set out in the relevant agreements.
Investment from MiCo IVD Holdings, LLC
In April 2022, the Company announced a US$45.2 million investment from MiCo IVD Holdings, LLP. The investment consisted of an equity investment of US$25.2 million and a seven-year, unsecured junior convertible note of US$20.0 million. The convertible note has an interest rate of 1.5% and interest is payable quarterly. The convertible note mandatorily converts into ADSs if the volume weighted average price of our ADSs is at or above US$12.96 for any five consecutive NASDAQ trading days.
Standby Equity Purchase Agreement
On February 24, 2026, we entered into a Standby Equity Purchase Agreement (the “SEPA”) with YA II PN, LTD. (“Yorkville”), pursuant to which the Company may, at its option, sell to Yorkville up to US$25 million in aggregate gross purchase price (the “Commitment Amount”) of ADSs. Subject to certain limitations and conditions set forth in the SEPA, ADSs may be sold to Yorkville at our discretion from time to time until the earlier of (i) February 24, 2029, and (ii) the date Yorkville has purchased the total Commitment Amount under the SEPA, such period being the “Commitment Period.” From time to time, and at our sole discretion, we may present Yorkville with Advance Notices (as defined in the SEPA) to purchase our ADS. The ADSs will be sold at a price per ADS equal to (a) in the event the Company elects a three trading day pricing period, 0.97 multiplied by the lowest daily VWAP of the ADSs during that pricing period, and (b) in the event the Company elects a one trading day pricing period, 0.95 multiplied by the VWAP of the ADSs during the pricing period.
Under the SEPA, the maximum number of ADSs we may elect to sell pursuant to an Advance Notice may not exceed the greater of (i) 100% of the average of the reported daily trading volume of our ADSs on our principal trading market during the five consecutive Trading Days immediately preceding that Advance Notice or (ii) 250,000, unless otherwise mutually agreed in writing. Purchases pursuant to an Advance Notice electing a single day pricing period are also subject to a volume threshold which, if not met, may result in a reduction to the number of ADSs to be purchased to 30% of that days’ trading volume. The SEPA also prohibits us from directing Yorkville to purchase ADSs if those ADSs, when aggregated with all other ADSs or ordinary shares then beneficially owned by Yorkville and its affiliates, would result in Yorkville and its affiliates beneficially owning more than 4.99% of our then-outstanding ordinary shares.
Leases
The Group has lease liabilities relating to right-of-use assets with lease maturities between 1 and 10 years.
Cash and cash equivalents
At December 31, 2025, the cash and cash equivalents balance was US$5.1 million. In the future, the amount of cash generated from operations will depend on a number of factors which include the following:
The ability of the Group to generate revenue growth from its existing product lines and from new products following the successful completion of its development projects;
The extent to which capital expenditure is incurred on additional property plant and equipment;
The level of investment required to undertake both new and existing development projects; and
Successful working capital management in the context of a growing business.
Liquidity
In our directors’ opinion, we will have access to sufficient funds to support its existing operations for at least the next 12 months by utilising existing cash resources and cash generated from operations and external financing. The directors have considered the Group’s current financial position and cash flow projections, taking into account all known events and developments.
We have incurred net losses and negative cash flows from operating activities in the past two years and we may not be able to achieve or maintain profitability or positive cash flow in the future. We have incurred losses of US$37.4 million and US$31.8 million in the years ended December 31, 2025 and 2024, respectively and had negative cash flows from operating activities of US$5.9 million and US$4.2 million, respectively.
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Additional funding may not be available on acceptable terms, or at all. In addition, we may not be able to access a portion of our existing cash, cash equivalents and investments due to market conditions. Further, as a result of geopolitical and macroeconomic events, including the Israel–Hamas war, the Russia–Ukraine war, and the escalating wars in the Middle East involving the United States, Israel, Iran and regional armed groups, the global credit and financial markets have experienced volatility and disruptions, including severely diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates, and uncertainty about economic stability. If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly or more dilutive.
Expansion into new businesses may present operating and marketing challenges different from those we currently encounter, and we cannot assure that new business initiatives will be successful enough to justify the time, effort, and resources that we devote to them or ultimately achieve profitability.
Cash Flows
As at December 31, 2025, our consolidated cash and cash equivalents were US$5.1 million. The following table presents the major components of net cash flows used in and provided by operating, investing and financing activities.
US$‘000
Net cash used in operating activities
(5,929)
(4,191)
Net cash used in investing activities
(6,223)
(22,968)
Net cash generated from financing activities
12,052
28,810
Net (decrease)/increase in cash and cash equivalents and short-term investments
(100)
1,651
Operating Activities
Net cash used in operating activities for the year ended December 31, 2025 amounted to US$5.9 million (2024: US$4.2 million), an increase in cash used of US$1.7 million. The increase in net cash used in operating activities is attributable to a increase in operating cash flows before changes in working capital of US$2.7 million alongside taxes paid of US$346 thousand compared to taxes received of US$1.0 million for the year ended December 31, 2024. These adverse movements were partially offset by cash inflows from changes in working capital increasing from US$4.1 million in 2024 to US$6.4 million in 2025, principally due to reductions in trade and other receivables and inventories.
Investing Activities
Net cash used in investing activities for the year ended December 31, 2025 amounted to US$6.2 million (2024: net cash generated of US$23.0 million). Investing cash outflows in 2025 primarily comprised payments to acquire intangible assets of US$6.1 million (2024: US$9.7 million), principally relating to capitalised development expenditure as part of the Group’s ongoing product development activities, together with additions to property, plant and equipment of US$0.1 million (2024: US$0.4 million) incurred in connection with the Group’s manufacturing and distribution operations. There were no acquisitions of trades or businesses in 2025, compared with US$12.9 million in 2024, which related primarily to the acquisition of the CGM assets of Waveform Technologies Inc.
Financing Activities
Net cash generated from financing activities for the year ended December 31, 2025 amounted to US$12.1 million, compared with a net cash inflow of US$28.8 million in 2024. Financing cash inflows in 2025 were primarily driven by additional drawdowns of US$15.0 million under the senior secured loan facility and share issuances of US$0.5 million. These inflows were partially offset by payments of lease liabilities of US$3.2 million and interest paid of US$0.3 million during the year.
In the comparative period, financing activities included higher drawdowns under the senior secured loan facility of US$30.2 million and share issuances of US$7.4 million. However, these inflows were more than offset by significantly higher interest payments of US$5.9 million, together with lease liability payments of US$2.5 million, resulting in an overall net cash inflow from financing activities in 2024.
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Research and Development, Patents and Licences, etc.
For information on research and development, patents and licences see “Item 4. Information on the Company—Item 4.B Business overview.”
For a discussion of trends, see Item 4.B—Business Overview, Item 5.A—Operating Results and Item 5.B—Liquidity and Capital Resources.
Our discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with IFRS. The preparation of these financial statements requires us to make estimates and judgements that affect the reported amount of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities.
On an on-going basis, we evaluate our estimates, including those related to intangible assets, contingencies and litigation. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgements about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
We believe the critical accounting policies described below reflect our more significant judgements and estimates used in the preparation of our consolidated financial statements.
Revenue Recognition
The Group recognises revenue when it transfers control over a good or service to a customer. Revenue is recognised to the extent that it is probable that economic benefit will flow to the Group and the revenue can be measured. No revenue is recognised if there is uncertainty regarding recovery of the consideration due at the outset of the transaction. Revenue, including any amounts invoiced for shipping and handling costs, represents the value of goods and services supplied to external customers, net of discounts and rebates and excluding sales taxes.
The core principle in IFRS 15 is a five-step model framework: 1) identify the contract(s) with a customer, 2) identify the performance obligations in the contract, 3) determine the transaction price, 4) allocate the transaction price to the performance obligations in the contract and 5) recognise revenue when (or as) the entity satisfies a performance obligation.
Revenue from products is generally recorded as of the date of shipment, consistent with typical ex-works shipment terms. Where the shipment terms do not permit revenue to be recognised as of the date of shipment, revenue is recognised when the Group has satisfied all of its performance obligations to the customer in accordance with the shipping terms.
In certain limited circumstances, the Group enters into bill‑and‑hold arrangements with customers, whereby products are invoiced and control transfers to the customer prior to physical delivery. The recognition of revenue under such arrangements requires judgement, including the assessment of whether the criteria specified in IFRS 15 for bill‑and‑hold transactions are met, in particular that the product is separately identified, is ready for physical transfer, and cannot be redirected or used to fulfil other orders. We assesses that the arrangement is substantive and that control has transferred to the customer. Revenue is recognised only when all relevant criteria are satisfied.
The Group operates a licenced referenced laboratory in the U.S. which provides testing services to institutional customers and insurance companies. In the U.S., billing practices and regulatory requirements generally require insurance companies to be billed the same amount per test. However, the amount that each insurance company pays for a particular test varies according to their own internal policies and this can typically be considerably less than the amount invoiced. We recognise lab services revenue for insurance companies by taking the invoiced amount and reducing it by an estimated percentage based on historical payment data. We review the percentage reduction annually based on the latest data. As a practical expedient, and in accordance with IFRS, we apply a portfolio approach to the insurance companies as they have similar characteristics. We judge that the effect on the financial statements of using a portfolio approach for the insurance companies will not differ materially from applying IFRS 15 to the individual contracts within that portfolio.
Revenue from services rendered is recognised in the statement of operations in proportion to the stage of completion of the transaction at the balance sheet date.
The Group leases instruments to customers typically as part of a bundled package. Where a contract has multiple performance obligations and its duration is greater than one year, the transaction price is allocated to the performance obligations in the contract by reference to their relative standalone selling prices. For contracts where control of the instrument is transferred to the customer, the fair value of the instrument is recognised as revenue at the commencement of the lease and is matched by the related cost of sale. Fair value is determined on the basis of standalone selling price. In the case where control of the instrument does not transfer to the customer, revenue is recognised on the basis of customer usage of the instrument. See also Note 1(v).
In obtaining these contracts, the Group incurs a number of incremental costs, such as sales bonus paid to sales staff, commissions paid to distributors and royalty payments. As the amortisation period of these costs, if capitalised, would be less than one year, the Group makes use of the practical expedient in IFRS 15.94 and expenses them as they incur.
A receivable is recognised when the goods are delivered as this is the point in time that the consideration is unconditional because only the passage of time is required before the payment is due.
The Group’s obligation to provide a refund for faulty products under the standard warranty terms is recognised as a provision, see Note 22 for details.
Research and development expenditures – capitalized development costs
Under IFRS as issued by IASB, we write-off research and development expenditures as incurred, with the exception of expenditures on projects whose outcome has been assessed with reasonable certainty as to technical feasibility, commercial viability and recovery of costs through future revenues. Such expenditure is capitalised at cost within intangible assets and amortised over its expected useful life of 15 years, which commences when the product is launched.
Acquired in-process research and development (IPR&D) is valued at its fair value at acquisition date in accordance with IFRS 3. The Company determines this fair value by adopting the income approach valuation technique. Once the fair value has been determined, the Company will recognise the IPR&D as an intangible asset when it: (a) meets the definition of an asset and (b) is identifiable (i.e., is separable or arises from contractual or other legal rights). IPR&D is tested for impairment on an annual basis, in the fourth quarter, or more frequently if impairment indicators are present, using projected discounted cash flow models. If IPR&D becomes impaired or is abandoned, the carrying value of the IPR&D is written down to its revised fair value with the related impairment charge recognised in the period in which the impairment occurs. If the fair value of the asset becomes impaired as the result of unfavourable data from any ongoing or future clinical trial, changes in assumptions that negatively impact projected cash flows, or because of any other information regarding the prospects of successfully developing or commercialising our programs, we could incur significant charges in the period in which the impairment occurs. The valuation techniques utilised in performing impairment tests incorporate significant assumptions and judgments to estimate the fair value, as described above. The use of different valuation techniques or different assumptions could result in materially different fair value estimates.
Factors which impact our judgement to capitalise certain research and development expenditure include the degree of regulatory approval for products and the results of any market research to determine the likely future commercial success of products being developed. We review these factors each year to determine whether our previous estimates as to feasibility, viability and recovery should be changed. At December 31, 2025 the carrying value of capitalised development costs was US$23.6 million (2024: US$20.9 million) (see Note 12 to the consolidated financial statements). The increase in 2025 was mainly due to additions of US$6.3 million partly offset by amortization of US$1.4 million and impairment of US$2.1 million.
Impairment of intangible assets and goodwill
Definite lived intangible assets are reviewed for indicators of impairment periodically while goodwill and indefinite lived assets are tested for impairment periodically, either individually or at the cash-generating unit level. Factors considered important, as part of an impairment review, include the following:
Significant underperformance relative to expected, historical or projected future operating results;
Significant changes in the manner of our use of the acquired assets or the strategy for our overall business;
Obsolescence of products;
Significant decline in our stock price for a sustained period; and
Our market capitalisation relative to net book value.
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When we determine that the carrying value of intangibles, non-current assets and related goodwill may not be recoverable based upon the existence of one or more of the above indicators of impairment, any impairment is measured based on our estimates of projected net discounted cash flows expected to result from that asset, including eventual disposition. Our estimated impairment could prove insufficient if our analysis overestimated the cash flows or conditions change in the future.
Goodwill and other intangibles are subject to impairment testing on a periodic basis. The recoverable amount of our nine cash-generating units (“CGUs”) is determined based on a value-in-use computation. The value-in-use calculations use cash flow projections based on the 2025 projections for each CGU and a further four years projections using estimated revenue and cost average growth rates of between 0% and 5%. At the end of the five-year forecast period, terminal values for each CGU, based on a long term growth rate of 2%, are used in the value-in-use calculations. The value-in-use represents the present value of the future cash flows, including the terminal value, discounted at a rate appropriate to each CGU. The pre-tax discount rates used range from 15% to 26% (2024: 17% to 28%). Refer to Item 18, Note 12 for further information.
The cash flows have been arrived at taking into account the Group’s financial position, its recent financial results and cash flow generation and the nature of the medical diagnostic industry, where product obsolescence can be a feature. However, expected future cash flows are inherently uncertain and are therefore liable to material change over time. The key assumptions employed in arriving at the estimates of future cash flows factored into impairment testing are subjective and include projected EBITDA margins, net cash flows, discount rates used and the duration of the discounted cash flow model. Significant under-performance in any of the Group’s major CGUs may give rise to a material impairment which would have a substantial impact on the Group’s income and equity.
Impairment charges increased from US$1.4 million for the year ended December 31, 2024 to US$2.2 million for the year ended December 31, 2025 (see Note 5). In year ended December 31, 2025, impairment loss was identified for two CGUs and specific development projects. Immco Diagnostics’s value in use was below the value of its relevant assets, and an impairment was provided for as at June 30, 2025 (US$17,000) and as at December 31, 2025 (US$3,000). Clark Laboratories Inc’s value in use was below the value of its relevant assets, and an impairment was provided for as at December 31, 2025 (US$30,000). During the year the Company reassessed the carrying value of its current development projects.
During 2023, the Company fully impaired its investment in imaware which constituted an amount paid of $0.7 million of the committed US$1.5 million investment with the remaining US$0.8 million, which had not yet been funded, recognized as an accrued liability. In 2025, the Company reversed US$0.8 million of the previously recognised impairment through profit or loss, corresponding to the accrued balance that was no longer payable under the terms of the investment agreement.
The value-in-use calculation is subject to significant estimation, uncertainty and accounting judgements and the following sensitivity analysis has been performed:
In the event that there was a reduction of 10% in the assumed level of future growth in revenue growth rate, which would represent a reasonably likely range of outcomes, there would be no additional impairment loss recorded at December 31, 2025.
In the event there was a 10% increase in the discount rate used to calculate the potential impairment of the carrying values, which would represent a reasonably likely range of outcomes, there would be no additional impairment loss recorded at December 31, 2025.
Allowance for slow-moving and obsolete inventory
We evaluate the realisability of our inventory on a case-by-case basis and adjust our inventory provision based on our estimates of expected losses. We write off inventory that is approaching its “use-by” date and for which no further re-processing can be performed. We also consider recent trends in revenues for various inventory items and instances where the realisable value of inventory is likely to be less than its carrying value. Given the allowance is calculated on the basis of the actual inventory on hand at the particular balance sheet date, there were no material changes in estimates made during 2025, 2024 or 2023 which would have an impact on the carrying values of inventory during those periods, except as discussed below. At December 31, 2025 our allowance for slow moving and obsolete inventory was US$7.1 million which represents approximately 27.4% of gross inventory value. At December 31, 2024 our allowance for slow moving and obsolete inventory was US$7.6 million, which represented approximately 28.3% of gross inventory value and at December 31, 2023 the provision was US$11.3 million, or approximately 36.3% of gross inventory value (see Note 16 to the consolidated financial statements).
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The allowance for slow moving and obsolete inventory has decreased by US$0.5 million between 2024 and 2025 primarily due to the utilisation of the provision through scrappage during the year.
Management is satisfied that the assumptions made with respect to future sales and production levels of these products are reasonable to ensure the adequacy of this provision. In the event that the estimate of the provision required for slow moving and obsolete inventory was to increase or decrease by 2% of gross inventory, which would represent a reasonably likely range of outcomes, then a change in allowance of US$0.5 million at December 31, 2025 (2024: US$0.5 million) (2023: US$0.6 million) would result.
Share-based payments
For equity-settled share-based payments (share options), the Group measures the services received and the corresponding increase in equity at fair value at the measurement date (which is the grant date) using a trinomial model. Given that the share options granted do not vest until the completion of a specified period of service, the fair value, which is assessed at the grant date, is recognised on the basis that the services to be rendered by employees as consideration for the granting of share options will be received over the vesting period.
Certain share options have been granted for which there is a condition that the options only become exercisable into ADSs when the market price of an ADS reaches a certain level. This is deemed to be a non-vesting condition. The term ‘non-vesting condition’ is not explicitly defined in IFRS 2, Share based Payment, but is inferred to be any condition that does not meet the definition of a vesting condition. The only condition for these options to vest is that the option holder continues service and there were no other conditions which would be considered non-vesting conditions. Non-vesting conditions are reflected in measuring the grant-date fair value of the share-based payment and there is no true-up in the measurement of the share-based payment for differences between the expected and the actual outcome of non-vesting conditions. If all service conditions are met, then the share-based payment cost will be recognized even if the option holder does not receive the share-based payment due to a failure to meet the non-vesting condition.
The expense in the statement of operations in relation to share options represents the product of the total number of options anticipated to vest and the fair value of those options; this amount is allocated to accounting periods on a straight-line basis over the vesting period.
Share based payments, to the extent they relate to direct labour involved in development activities, are capitalised.
The proceeds received net of any directly attributable transaction costs are credited to share capital (nominal value) and share premium when the options are exercised. The Group does not operate any cash-settled share-based payment schemes or share-based payment transactions with cash alternatives as defined in IFRS 2.
Senior secured term loan and related derivative balances
On December 22, 2025, the Company entered into a second amendment to its Sixth Amended and Restated Credit Agreement with Perceptive, which provided for an additional US$5.0 million term loan and a Senior Convertible Note in the amount of $93.3 million, evidencing the outstanding balance of the Term Loans at the time. Up to $60 million of the Senior Convertible Note is convertible, at the holder’s election, into ADSs at 97% of volume-weighted average price (“VWAP”), subject to a US$1.03 floor price and other limitations, including a 9.9% beneficial ownership cap, which may in practice limit the holder’s ability to convert. The amendment also extended the maturity date to January 15, 2027, provided that accrued and unpaid interest through the amendment date and interest for December 2025 and January 2026 would be paid-in-kind and allowed for a further 3.5% reduction in the Applicable Margin to 5.25%, once the outstanding principal amount of the term loans falls below $50 million. See the description in Item 10.C. – Material Contracts, under the heading “Credit Agreement and Senior Convertible Note.”
In parallel, the Company entered into a Conversion Rights Agreement permitting the US$5.0 million Waveform milestone payment obligation to be satisfied, at Perceptive’s election, in ADSs, and terminating up to US$15.0 million of contingent consideration in exchange for a US$7.5 million obligation that may likewise, be satisfied in ADSs. These are convertible at 97% of VWAP. See the description in Item 10.C. – Material Contracts, under the heading “Conversion Rights Agreement”.
Litigation
From time to time, we may be subject to various claims and contingencies in the ordinary course of business, including those related to litigation, business transactions, our intellectual property, regulatory compliance, employee-related matters and taxes, and others. When we are aware of a claim or potential claim, we assess the likelihood of any loss or exposure. If it is probable that a loss will result and the amount of the loss can be reasonably estimated, we will record a liability for the loss. In addition to the estimated loss, the recorded liability includes probable and estimable legal costs associated with the claim or potential claim. There is no assurance that such matters will not materially and adversely affect our business, financial position, and results of operations or cash flows.
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Item 6. Directors, Senior Management and Employees
Executive Officers and Directors
We are managed by a board of directors, which is currently comprised of four members, and our executive senior management. The following table presents information about our current executive officers and members of our board of directors. The term executive officer refers to any person in charge of a principal business unit, division or function (such as sales, administration or finance), any other officer who performs a policy making function or any other person who performs similar policy making functions for the registrant. Executive officers of subsidiaries may be deemed executive officers of the registrant if they perform such policy making functions for the registrant.
Name
Title
Directors
John Gillard
Director, President and Chief Executive Officer
Ronan O’Caoimh
Director, Founder
Paul Tivnan
Independent Director
Andrew Omidvar PhD,MBA
Executive Officers
Matthew Wictome
Vice President of Quality and Regulatory Affairs
Gary Keating, PhD
Chief Technology Officer
Eibhlín Kelly
Chief Information Officer
Changes in Executive Officers and Board composition
In August 2025, Paul Tivnan was appointed to the board of directors as a non-executive director and subsequently, as Chair of the Audit Committee at the Company’s AGM on September 30, 2025. Jim Walsh, PhD retired by rotation from the Trinity Biotech plc’s board of directors at the Company’s AGM on September 30, 2025 in accordance with the Company’s constitution. Similarly, Tom Lindsay’s directorship concluded at the Company’s AGM on September 30, 2025. Susan O’Connor was appointed as Interim CFO in April 2025 succeeding Louise Tallon, who stepped down as CFO effective April 11, 2025. In December 2025, Susan O’Connor was replaced by Paul Murphy, now serving as Interim CFO. In addition, Matthew Wictome succeeded Ian Wells as Vice President of Quality and Regulatory Affairs in April 2025. Colm Molloy served as Group Director of Human Resources and Culture until December 2025.
John Gillard, Director, President and Chief Executive Officer, joined Trinity Biotech in November 2020 as Chief Financial Officer, Secretary to the Board of Directors and was appointed to the Board as Executive Director. Mr. Gillard assumed the role of CEO and President of Trinity Biotech in December 2023. Mr. Gillard is both a Chartered Accountant and Chartered Tax Advisor, having trained at PWC. Prior to joining Trinity Biotech, Mr. Gillard held a number of senior financial roles including from 2012 to 2016 at Alphabet Inc./Google, and from Nov 2016 to May 2020 at ION Investment Group. From June 2020 until November 2020, Mr. Gillard also acted as a business consultant. Mr. Gillard holds a Bachelor of Commerce degree from the National University of Ireland Galway and a Masters degree in Accounting from University College Dublin.
Ronan O’Caoimh, Director, Founder, co-founded Trinity Biotech in June 1992 and acted as Chief Financial Officer until March 1994 when he became Chief Executive Officer. He was also elected Chairman in May 1995. On May 3, 2022, Mr. O’Caoimh stepped down as Chairman, and on October 3, 2022, Mr O’Caoimh stepped down as Chief Executive Officer. Prior to joining Trinity Biotech, Mr O’Caoimh was Managing Director of Noctech Limited, an Irish diagnostics company. Mr O’Caoimh was Finance Director of Noctech Limited from 1988 until January 1991 when he became Managing Director. Mr O’Caoimh holds a Bachelor of Commerce degree from University College Dublin.
Andrew Omidvar, Independent Director joined the Board of Trinity Biotech in December 2023. With over twenty-five years of experience leading cross-functional teams to deliver cutting edge technology solutions in a variety of industries. He brings experience in development and product support for data and AI based systems in the medical device industry. Most recently Dr. Omidvar served as Vice President of Government R&D and Enterprise for Philips.
Paul Tivnan, Independent Director, joined the Board of Trinity Biotech in August 2025, bringing over 25 years of senior leadership experience in finance, capital markets, and corporate governance in public and PE backed companies across multiple industries. He currently serves as Chief Financial Officer of Deriva Energy LLC, a major U.S. renewable power producer and Brookfield portfolio company and previously held CFO roles at Brookfield Renewable Ireland and Ardmore Shipping Corporation (ticker “ASC”). Mr. Tivnan is a Certified International Director (INSEAD) and has completed executive governance programs at INSEAD and London Business School, following earlier work in Financial Services Advisory at Ernst & Young. He holds a B.A. in Accounting & Finance and a Master of Business Studies from Dublin City University and is a Fellow of the Institute of Chartered Accountants of Ireland, a Chartered Tax Advisor, and a member of the Institute of Chartered Shipbrokers.
Dr. Matthew Wictome, Vice President of Quality and Regulatory Affairs, was appointed to this role in January 2025. He is also the Founder and Managing Director of Datod Consulting, specialising in building world-class Quality organisations. With over 30 years of experience in the healthcare sector, Dr. Wictome has held leadership roles in R&D and Quality at Johnson & Johnson, Ortho Clinical Diagnostics, and the UK’s Health Protection Agency. He holds a BSc in Biochemistry from the University of Bath, a PhD in Biochemistry from the University of Southampton, and an MSc in Strategy, Change and Leadership from the University of Bristol’s Executive Development Program. Dr. Wictome is also the co-author of Transforming Quality Organizations: A Practical Guide (Business Expert Press, New York, April 2023).
Paul Murphy, Interim Chief Financial Officer, joined the Company in December 2024 as Head of Group Reporting. Mr. Murphy is a PwC‑trained Chartered Accountant (FCA) with broad experience across finance leadership, external reporting, technical accounting and business transformation in both private and public company environments. Prior to joining Trinity Biotech, he served as Finance Director of The Happy Pear, where he led the Group’s finance, reporting and commercial functions. Earlier in his career, Mr. Murphy was a Senior Manager with PricewaterhouseCoopers in Dublin, working with multinational and listed clients across audit and advisory engagements. Mr. Murphy holds a Bachelor of Business & Legal Studies from University College Dublin.
Gary Keating, Chief Technology Officer, joined us in October 2022. Dr Keating graduated from the University of Ulster at Jordanstown with a BSc in Applied Biochemical Sciences and pursued his interest in biosensors in Prof Richard O’Kennedy’s Applied Biochemistry group at DCU, where he worked on the development of antibody-based optical biosensors for the detection of small drug molecules. Dr Keating earned his PhD in 1998; the external examiner for his doctorate was Prof George Guilbault, who described the first amperometric glucose electrode. Prior to joining Trinity Biotech, Dr Keating held the position of CTO with Hibergene Diagnostics Ltd. from October 2014 to August 2022. Previous to Hibergene, Dr Keating held a range of technical leadership roles in start-up and multinational diagnostics companies, including Transfer Manager at Abbott Diagnostics and R&D Manager at Diasorin Ireland.
Eibhlín Kelly, Chief Information Officer, has served as our Chief Information Officer since September 2015. Previously, she served as Customer Services Manager at Lynq Limited between 2011 and 2015, and Service Delivery/Support Manager at Trinity Biotech between 2005 and 2011. She graduated with an honour’s degree in Business Information Systems Development from Dublin Institute of Technology.
There are no family relationships between any of the directors or members of senior management named above.
Our Memorandum and Articles of Association of the Company (the “Articles”) provide for a board of directors of not less than four and not more than ten members with the exact number of directors, from time, to time, determined solely by a resolution of our board of directors.
Our board of directors is currently composed of four directors. Officers serve at the pleasure of the board of directors, subject to the terms of any agreement between the officer and us.
Pursuant to the terms of the Securities Purchase Agreement signed by Trinity Biotech plc and MiCo IVD Holdings LLC (“MiCo”) on April 11, 2022, and the Redeemeable Unsecured Convertible Loan Note issued by us on May 3, 2022, MiCo have the right to nominate up to four individuals for consideration by the Nomination Committee of the Board of Directors for appointment to the Board of Directors, subject to certain minimum holding requirements. Three of MiCo's four nominees are required to meet the independence standards set out in the NASDAQ stock Market Rules at all times and at least one of those nominees must have substantial experience at a diagnostics testing business having annualised revenues of greater than US$1 billion. In considering MiCo's nominees, the Nomination Committee of the Board of Directors is required to take into consideration the need for the Company to retain its Irish tax status and status as a foreign private issuer under applicable federal securities laws.
We are not aware of any other arrangements or understandings with major shareholders, customers, suppliers or others, pursuant to which any person referred to above was selected as a director or member of senior management.
76
The 2025 remuneration scheme was approved by the Board of Directors.
Total directors and independent directors’ remuneration, excluding pension and share options, for the year ended December 31, 2025 amounted to US$886,000. The pension charge for the year amounted to US$38,000. See Item 18, Note 9 to the consolidated financial statements. The split of directors’ remuneration set out by director is detailed in the table below:
Salary/Other
payments/
Benefits
Performance
related bonus
Transaction
Defined
contribution
pension
Director
President and Chief Executive Officer
660
441
*
—
1,139
1,213
Director, Founder & Executive Advisor
Jim Walsh
Executive Director Business Development
Tom Lindsay
Andrew Omidvar
886
1,365
1,494
* Amount relates to a bonus provision for the year ended December 31, 2025. The final amount remains subject to confirmation.
As at December 31, 2025, there was US$1,052,000 (2024 US$440,000) accrued to provide pay, pension, retirement or similar benefits for the directors.
In 2025, no share options were granted by the directors to subscribe for ‘A’ ordinary shares (or ADSs). Accordingly, there were no net options granted during the year (2024: 2,606,000).
In addition, see Item 7 - Major Shareholders and Related Party Transactions for further information on the compensation of Directors and Officers.
Compensation of Executive Senior Management
Compensation of our executive officers is composed primarily of base salary and the payment of short-term and mid-term cash bonuses. Cash bonuses are generally tied to the achievement of financial performance indicators and strategic objectives, and they may vary as a percentage of base salary depending upon the level of responsibilities of the executive officer. Our executive compensation package is also complemented by long-term incentives in the form of stock options.
One of our key priorities is to build a performance culture and drive ownership and accountability in the Company. A share-based compensation model that ensures shareholder alignment is regarded as core to this transformation and is currently in the process being rolled out to staff and senior management across the Company. To facilitate this shareholder aligned share-based compensation model for employees and senior management, on December 15, 2022, our Board approved an amendment to the Trinity Biotech Employee Share Option Plan 2020 to increase the number of ordinary shares issuable under such plan by 30 million Class “A” ordinary shares (the equivalent to 1.5 million ADS). Performance share-based compensation awards are intended to closely align the goals of our broader team with those of our shareholders in the creation of shareholder value. The majority of Mr. Gillard’s options are performance share options and are structured such that they are exercisable only if the market price of the Company's ADSs increases to certain levels (US$5.00, US$7.50, US$10.00, US$15.00, US$20.00 and U$25.00 per ADS) during the term of the option.
For the financial year ended December 31, 2025, our non-director executive officers as a group, received aggregate compensation of US$1,187,000 for services they rendered in all capacities during 2025, which amount includes base salary, commissions, bonuses, ex gratia payments and benefits in kind, excluding share options.
This does not include any of the directors listed above. Compensation paid to Ms. Tallon, Dr. Wells and Ms. O’Connor for their service during 2025 is included in the aggregate compensation disclosed for executive officers.
Our Articles of Association provide that one third of the directors for the time being other than a director holding an executive office with us or, if their number is not three or a multiple of three, then the number nearest to, but not exceeding, one third shall retire from office at each annual general meeting but if at any annual general meeting the number of directors who are subject to retirement by rotation is two, one of such directors shall retire and, if the number of such directors is one, that director shall retire. The directors to retire at each annual general meeting shall be the directors who have been longest in office since their last appointment. As between directors of equal seniority the directors to retire shall, in the absence of agreement, be selected from among them by lot. Subject as aforesaid, a retiring director shall be eligible for re-appointment and shall act as a director throughout the meeting at which he retires.
The Board of Directors may establish committees pursuant to authority delegated under the Company’s Articles of Association, including audit, remuneration and employee compensation committees.
The Company typically has a Remuneration Committee acting under authority delegated by the Board. which is responsible for considering and approving executive directors’ remuneration including bonuses and share-based awards. The Board has from time to time appointed independent consulting firms to advise the Board on recruitment and compensation matters for directors and senior management.
The Audit Committee reviews the Group’s annual and interim financial statements and reviews reports from management on the effectiveness of the Group’s internal controls. It also oversees the appointment, scope and performance of the external auditors, reviews the scope and results of the external audit and monitors the relationship with the auditors.
The Board of Directors has established an employee compensation committee consisting of the CEO and CFO. This committee has delegated authority from the Board to approve share-based compensation grants to employees of the Group, other than executive directors, pursuant to the terms of the Employee Share Option Plan.
The Company may also operate a Nomination Committee for appointments to the Board of Directors.
Because we are a foreign private issuer, it is not required to comply with all of the corporate governance requirements set forth in NASDAQ Rule 5600 as they apply to U.S. domestic companies.
Indemnification of Directors and Officers and Limitations of Liability
Subject to exceptions, the Companies Act 2014 of Ireland, (the “Companies Act 2014”) does not permit a company to exempt a director or certain officers from, or indemnify a director against, liability in connection with any negligence, default, breach of duty or breach of trust by a director in relation to the company.
The exceptions allow a company to: (a) purchase and maintain directors and officers insurance against any liability attaching in connection with any negligence, default, breach of duty or breach of trust owed to the company; and (b) indemnify a director or such other officer against any liability incurred in defending proceedings, whether civil or criminal, (i) in which judgment is given in his or her favor or in which he or she is acquitted or (ii) in respect of which an Irish Court grants him or her relief from any such liability on the grounds that he or she acted honestly and reasonably and that, having regard to all the circumstances of the case, he or she ought fairly to be excused for the wrong concerned.
The Articles include a provision which, subject to the provisions of the Companies Act 2014 as aforesaid, entitles every present and former director and other officer of the Company to be indemnified out of the assets of the Company (other than any person (whether an officer or not) engaged by the Company as auditor) against any loss or liability incurred by him or her for negligence, default, breach of duty or breach of trust in relation to the affairs of the Company or otherwise incurred by him or her in the execution and discharge of his or her duties to the Company.
Under the Companies Act 2014 and the Articles, the Company may purchase and maintain directors’ and officers’ liability insurance, at the expense of the Company, for the benefit of any of its present and former Directors and other officers.
The following table details certain data on the average number of employees of Trinity Biotech and its consolidated subsidiaries, including full-time, part-time, and temporary personnel who work under the direction and supervision of the Company:
Year Ended December 31
Numbers of employees by geographic location
United States
113
174
203
133
185
143
United Kingdom
Brazil
Total workforce
287
401
380
Numbers of employees by category of activity
Research scientists & technicians
Manufacturing/Operations
166
246
207
Quality Assurance
Finance/Administration
Sales & Marketing
We consider our employees the most valuable asset of our company. We offer competitive compensation and comprehensive benefits to attract and retain our employees. The remuneration and rewards include retention through share-based compensation and performance-based bonuses. We generally provide our employees with benefits and working conditions beyond the required minimums in each geographic and regulatory environment in which the Group operates.
We believe that an engaged workforce is key to maintaining our ability to innovate. We have been successful in integrating new employees into the business and keeping our employees engaged. Investing in our employees’ career growth and development is an important focus for us. We offer learning opportunities and training programs including workshops, guest speakers and various conferences to enable our employees to advance in their chosen professional paths. We are committed to providing a safe work environment for our employees.
Beneficial Ownership of Executive Officers and Directors
Stock Option Plans
The Board of Directors have adopted the Employee Share Option Plans (the “Plans”) with the most recently adopted Share Option Plan being the Company’s 2020 Amended & Restated Plan. The purpose of these Plans is to provide Trinity Biotech’s employees, consultants, officers and directors with additional incentives to improve Trinity Biotech’s ability to attract, retain and motivate individuals upon whom Trinity Biotech’s sustained growth and financial success depends. These Plans are administered by the Board of Directors. Options under the Plans may be awarded only to employees, officers, directors and consultants of Trinity Biotech.
The exercise price of options is determined by the Board of Directors, through its remuneration and employee compensation committees as the case may be. The term of an option will be determined by the Board, provided that the term may not exceed ten years from the date of grant. All options will terminate 90 days after termination of the option holder’s employment, service or consultancy with Trinity Biotech (or one year after such termination because of death or disability) except where a longer period is approved by the board of directors.
Under certain circumstances involving a change in control of Trinity Biotech, the Board may accelerate the exercisability and termination of options.
As of March 31, 2026, our directors and executive officers as a group, then consisting of 8 persons, held options to purchase an aggregate of 29,593,337‘A’ Ordinary shares (1,479,669 ADS equivalent), having exercise prices ranging from US$0.12 per ‘A’ ordinary share (US$2.40 per ADS) to US$0.73 per ‘A’ ordinary share (US$14.60 per ADS) and expiration dates ranging from 2026 to 2031. Any options granted prior to the fourth quarter of 2022 vest over a two to four year period and have no performance conditions. The options granted in and since the fourth quarter of 2022 are performance share options.
The following table sets forth certain information as of March 31, 2026, regarding the beneficial ownership by each of our directors and executive officers:
Number of ‘A’ Ordinary Shares Beneficially Owned (1)
Percentage of Ownership (2)
Ronan O’Caoimh (3)
17,129,996
4.2
John Gillard (4)
11,200,000
2.7
Andrew Omidvar (5)
612,500
0.2
Gary Keating
Executive officers and directors as a group (8 persons)
28,942,496
6.9
Less than 1%
(1) Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to securities. Ordinary Shares relating to options currently exercisable or exercisable within 60 days of the date of this table are deemed outstanding for computing the percentage of the person holding such securities but are not deemed outstanding for computing the percentage of any other person. Share options that have a performance condition related to the share price of the equity of the Company are deemed to be exercisable irrespective of whether the performance condition has been, or is expected to be, satisfied within 60 days of the date of this table. Except as indicated by footnote, and subject to community property laws where applicable, the persons named in the table above have sole voting and investment power with respect to all shares shown as beneficially owned by them.
(2) The percentages shown are based on 405,017,380 ‘A’ Ordinary Shares issued and outstanding as of March 31, 2026.
(3) Represents (a) 9,724,160 ‘A’ ordinary shares and (b) 7,405,836 ‘A’ ordinary shares underlying options that are currently vested and exercisable or that vest within sixty days of March 31, 2026. Includes options issued to Darnick Company which in the past provided Trinity Biotech with the services of Mr. O’Caoimh as Chief Executive Officer.
(4) Represents (a) 200,000 ‘A’ ordinary shares and (b) 11,000,000 ‘A’ ordinary shares underlying options that are currently vested and exercisable or that vest within sixty days of March 31, 2026.
(5) Represents 612,500‘A’ ordinary shares underlying options that are currently vested and exercisable or that vest within sixty days of March 31, 2026.
80
As of March 31, 2026, 29,593,337 (1,479,669 ADS equivalent) of the options outstanding were held by the directors of Trinity Biotech as follows:
Director/Company Secretary
Number of
Options ‘A’
Shares
Options
ADS
Equivalent
Exercise
Price (Per
‘A’ Share)
Exercise Price
(Per ADS)
Hurdle
Price 2
Expiration Date of
600,000
30,000
0.67
13.40
None
23/10/2027
1,400,000
70,000
0.27
5.40
25/03/2029
2,000,000
100,000
0.29
5.80
19/12/2029
666,667
33,333
$15.00
$20.00
$25.00
7,000,000
350,000
0.12
2.40
18/12/2030
2,333,333
116,667
$5.00
$7.50
2,333,334
$10.00
Ronan O’Caoimh 1
4,060,000
203,000
0.69
13.80
14/06/2026
333,336
16,667
0.19
3.80
20/03/2027
2,400,000
120,000
0.73
14.60
17/11/2027
700,000
35,000
0.14
2.80
28/01/2031
233,333
11,667
233,334
1 Includes options issued to Darnick Company which in the past provided us with the services of Mr. O’Caoimh as Chief Executive Officer
2 Share options with a hurdle price are structured such that they may only become exercisable into ADSs when the average closing price of our ADSs, for ten trading days out of the thirty previous trading days, is equal to or greater than the relevant hurdle price of US$5.00, US$7.50, US$10.00, $15.00, $20.00 and $25.00 per ADS (adjusted for any stock splits, reverse splits or equivalent reorganisations) during the life of the option. At 31 March, 2026, none of the directors’ share options with a hurdle price were exercisable as the hurdle price condition has not been achieved.
As of March 31, 2026 the following total options were outstanding:
Number of ‘A’
Range of
Range of Exercise
Ordinary Shares
Price
Subject to Options
per Ordinary Share
per ADS
Total options outstanding
40,017,505
$
US0.12-US$1.10
US2.40-US$25.80
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Item 7. Major Shareholders and Related Party Transactions
As of March 31, 2026, there were 405,017,380 ‘A’ Ordinary shares (excluding treasury shares) outstanding. Such total excludes 39,346,672 Ordinary shares issuable upon the exercise of outstanding options and 66,200,000 Ordinary shares issuable upon the exercise of outstanding warrants.
The following table sets forth certain information regarding the beneficial ownership of our ordinary shares, as of March 31, 2026, by each person who we believe beneficially owns 5% or more of our outstanding ordinary shares and all of our directors and executive officers as a group. Except as otherwise noted, all of the persons and groups shown below have sole voting and investment power with respect to the shares indicated.
ADSs
Beneficially
Percentage
Owned
ownership (2)
MiCo IVD Holdings, LLC
44,759,388
(3)
2,237,969
16.2%
Perceptive Credit Holdings III, LP
(4)
9.99%
Novus Diagnostics Ltd
22,399,760
(5)
1,119,988
5.5%
All directors and officers as a group
(1)
1,447,125
7.2%
(2) The percentages shown are based on 405,017,380 ‘A’ Ordinary Shares outstanding (excluding treasury shares).
(3) Based upon a Schedule 13D filed with the SEC on December 4, 2025, by MiCo IVD Holdings, LLC (“MiCo”) and the other reporting persons named therein. The percentage ownership in the table above includes 24,691,340 ‘A’ Ordinary shares, represented by 1,234,567 ADSs, that would be issuable upon conversion of MiCos Convertible Note a conversion price of U.S. $16.20 per ADS. The principal business address of MiCo IVD Holdings, LLC is 85 Orchard Road. Skillman, New Jersey 08558 United States.
(4) Based upon a Schedule 13D/A filed with the SEC on January 26, 2026, by Perceptive Advisors LLC, Perceptive Credit Holdings II, L.P. and Perceptive Credit Holdings III, L.P. Perceptive does not currently own any issued ‘A’ Ordinary Shares of the Company. The percentage ownership in the table above reflects Perceptive’s beneficial ownership as reported in its Schedule 13D/A filing, which includes ordinary shares issuable upon conversion of Perceptive’s senior convertible note, the exercise of outstanding warrants, and the settlement of milestone and contingent payment obligations. The number of shares beneficially owned substantially exceeds the Company’s currently issued share capital however all such instruments are subject to a 9.9% beneficial ownership cap, which limits the number of ‘A’ Ordinary Shares that Perceptive may acquire at any one time. The principal business address of the parties noted above is 51 Astor Place 10th Floor, New York, NY 10003.
(5) Based upon a Schedule 13D filed on March 6, 2026, by Novus Diagnostics Ltd. The principal business address of Novus Diagnostics Ltd. is c/o NICB, DCU, Glasnevin, Dublin, D09NR58, Ireland.
Significant Changes in the Ownership of Major Shareholders
To our knowledge, other than as disclosed in the tables below there has been no significant change in the percentage ownership held by any major shareholder since January 1, 2023.
The following shareholders have disclosed ownership above 5% since January 1, 2023 but their ownership is below 5% as at March 31, 2026 according to their Schedule 13G filings, except as indicated otherwise.
Owned (1)
‘A’ Ordinary
Voting
Power
Date of Filing
Renaissance Technologies LLC
5,573,752
278,688
1.5%
February 13, 2023
Stonehill Capital Management LLC
6,690,592
334,530
1.8%
The ownership for the following shareholders rose above 5% since January 1, 2023:
11.2%
16.5%
December 17, 2024
0.0%
(2)
January 26, 2026
(1) The percentage ownership in the table above for MiCo IVD Holdings, LLC includes the conversion of the maximum number of ‘A’ Ordinary Shares as permitted by the conversion terns of the Convertible Note.
(2) The percentage ownership in the table above for Perceptive Credit Holdings II, L.P. and Perceptive Credit Holdings III, L.P. reflects the maximum percentage of ‘A’ Ordinary Shares that Perceptive is permitted to beneficially own under the 9.9% beneficial ownership cap contained in its financing agreements with the Company
Major Shareholders Voting Rights
Our major shareholders do not have different voting rights.
The following is a description of our related party transactions since January 1, 2023.
The Group has entered into various arrangements with JRJ Investments (“JRJ”), a partnership owned by Mr. O’Caoimh and Dr Walsh, a director and a former director respectively, of Trinity Biotech, and directly with Mr. O’Caoimh, to provide for current and potential future needs to extend its premises at IDA Business Park, Bray, Co. Wicklow, Ireland.
The Group entered into an agreement for a 25-year lease with JRJ effective from December 2003 for offices adjacent to its then premises at IDA Business Park, Bray, Co. Wicklow, Ireland with an annual rent is €381,000 (US$429,000). Upward-only rent reviews are carried out every five years and there have been no increases arising from these rent reviews.
In 2007, the Group also entered into 25-year lease agreements with Mr. O’Caoimh and Dr Walsh for a 43,860 square foot manufacturing facility in Bray, Ireland. The annual rent for the manufacturing facility is €787,000 (US$887,000). Subsequent to the signing of this lease, the ownership of the building transferred from JRJ to Mr. O’Caoimh solely. A rent review became effective on 1 July 2022 and, following an independent valuation, the annual rent increased to €1,050,000 (US$1,183,000), with backdated rent accruing from that date. Included within overhead costs in cost of sales in 2024 is an amount of US$659,000 in respect of this backdated rent.
In 2016, the Group also entered into 10-year lease agreement with Mr. O’Caoimh for a warehouse of 16,000 square feet adjacent to the leased manufacturing facility in Bray, Ireland. The annual rent for the warehouse is €144,000 (US$162,000). A rent review became effective on 1 July 2021 and, following an independent valuation, the annual rent increased to €170,560 (US$192,245), with backdated rent accruing from that date. Included within overhead costs in cost of sales in 2024 is an amount of US$97,000 in respect of this backdated rent. The lease is due to expire in June 2026, and the Group intends to vacate the premises on expiry of the lease.
Independent valuers advised the Group that the rent in respect of each of the leases represents a fair market rent.
At the time that the arrangements were entered into, Trinity Biotech and its directors (except for Mr O’Caoimh and Dr Walsh who expressed no opinion on this point) believed they represented a fair and reasonable basis on which the Group could meet its ongoing requirements for premises. Dr Walsh has no ownership interest in the additional space adjoining the warehouse owned by Mr O’Caoimh and was therefore entitled to express an opinion on this arrangement.
In September 2024, the Company completed the acquisition of Metabolomics Diagnostics Ltd ("Metabolomics") for consideration of approximately US$0.9 million, satisfied through the issuance of approximately 0.27 million ADSs and the extinguishment of amounts owed to the Company totalling US$0.4 million. At the time of the acquisition, Dr. Jim Walsh, then a director of the Company, held a 6% minority shareholding in Metabolomics. Based on the net assets acquired and goodwill recognised, the value attributable to Mr. Walsh’s interest was estimated at approximately US$55,000. Dr. Walsh fully disclosed his interest, and the acquisition was approved unanimously by the board, with appropriate procedures followed to manage the potential conflict of interest, including the passing of a resolution under the Company's Constitution to authorise Mr. Walsh’s involvement in the decision-making process. The transaction was conducted at arm’s length, and the board determined that it was in the best interests of the Company.
At 31 December 2025, an amount of US$984,000 (2024: US$658,000) in respect of bonus compensation due to the Chief Executive Officer remained unpaid and is included within accrued expenses. The unpaid balance reflects a voluntary deferral agreed by the Chief Executive Officer. The balance is unsecured and bears no interest.
Indemnity Agreements
We have entered into customary agreements with each of our current directors and executive officers to indemnify them to the fullest extent permitted by law, subject to limited exceptions.
Related Person Transaction Policy
Our Board of Directors has adopted an interested party transaction policy, which governs the identification, reporting and approval of transactions with interested parties.
Item 8. Financial Information
Consolidated Financial Statements
See Item 18. “Financial Statements.”
Export Sales
In the year ended December 31, 2025, the amount of our export sales (i.e., sales outside of Ireland) was approximately US$43.6 million which represents 99.6% of our total sales. In the year ended December 31, 2024, export sales were approximately US$61.4 million, or 99.8% of total sales, while in the year ended December 31, 2023, export sales totaled approximately US$56.7 million, representing 99.8% of total sales.
Legal and Arbitration Proceedings
From time to time, we may be involved in various claims and legal proceedings related to claims arising out of our operations. We are not currently a party to any material legal proceedings, including any such proceedings that are pending or threatened, of which we are aware, other than as disclosed herein.
Dividend Policy
We have not paid a cash dividend on our ordinary shares or ADSs since 2015 and do not intend to pay cash dividends on our ADSs in the foreseeable future. Our earnings and other cash resources will be used to continue the development and expansion of our business. Any future dividend policy will be determined by our Board of Directors and will be based upon conditions then-existing, including our results of operations, financial condition, current and anticipated cash needs, contractual restrictions and other conditions.
Except as otherwise disclosed in this Annual Report, no significant change has occurred since December 31, 2025.
Item 9. The Offer and Listing
Trinity Biotech’s ADSs are listed on the NASDAQ Global Market under the symbol “TRIB” and the depositary bank for the ADSs is The Bank of New York Mellon.
Trinity Biotech’s ADSs, each representing twenty ordinary shares, are listed on the NASDAQ Global Market under the symbol “TRIB” and the depositary bank for the ADSs is The Bank of New York Mellon.
Not Applicable.
Item 10. Additional Information
Copies of our Articles are filed as Exhibit 1.1 to this Annual Report. The information called for by this Item 10.B. is included in Exhibit 2.1 to this Annual Report and is incorporated herein by reference.
Irish Law
Each of Trinity Biotech’s principal subsidiary undertakings incorporated in Ireland (refer to Item 18, Note 32) is registered as a private company limited by shares under the Companies Act 2014. Pursuant to Irish law, Trinity Biotech must maintain a register of its members. This register is open to inspection by members free of charge and to any individual on the payment of a nominal fee. The books containing the minutes of proceedings of the general meetings of Trinity Biotech are required to be kept in Ireland and are kept at the registered office of the Company and are open to the inspection of any member without charge. Minutes of meetings of the board of directors are not open to inspection by shareholders. Trinity Biotech is also obliged to keep proper accounting records. Shareholders do not have a statutory right to inspect the accounting records of the Company. The only financial records, which are available to members, are the statutory financial statements, which are sent to members together with the Company’s annual report. Irish law also obliges Trinity Biotech to file information regarding certain events relating to the Company (such as changes to share rights, changes to the board of directors etc). This information is filed with the Companies Registration Office in Ireland and is open to public inspection. The Companies Act 2014 permits members to approve certain corporate actions by written resolution, provided that the relevant resolution is signed by all the members for the time being entitled to vote and attend at general meeting. A general meeting can be convened by members holding not less than 50 per cent of the paid-up share capital of the Company carrying voting rights at general meetings. In addition, the directors of the Company are required to convene a general meeting forthwith upon the deposit of a requisition signed by members holding not less than one-tenth of the paid up share capital of the Company carrying voting rights at general meetings. Trinity Biotech is generally permitted, subject to Irish company law, to issue shares with preferential rights, including preferential rights as to voting, dividends or rights to a return of capital on a winding up of the Company. Any member who complains that the affairs of the Company are being conducted or that the powers of the directors of the Company are being exercised in a manner oppressive to them or any of the members, or in disregard of their interests as members, may apply to the Irish Courts for relief. Shareholders do not have a general right to bring proceedings in respect of wrongs done to the Company.
Directors have extensive and wide–ranging duties under Irish law. These arise from both common law and statute (principally the Companies Act 2014, which codified a number of key fiduciary duties). Our directors owe their duties individually and primarily to Trinity Biotech and not its shareholders (although there is a requirement that directors consider the interests of employees in addition to those of the Company). Additionally, directors will also need to have regard to the interests of creditors, where a director believes, or has reasonable cause to believe, that a company is, or is likely to be, unable to pay its debts, or becomes aware of the company’s insolvency. All directors have equal and overall responsibility for the management of the Company. Directors who also serve as employees will have additional responsibilities and duties arising under their employment agreements and may be expected to exercise a greater degree of skill and diligence than non-executive directors. Those duties include duties to act in good faith in the interests of Trinity Biotech, to act honestly and responsibly in the conduct of the Company’s affairs, to act in accordance with the Company’s Constitution and exercise their powers only for purposes allowed by law, not misuse the Company’s property, not agree to restrict their power to exercise an independent judgment (subject to limited exceptions) and avoid conflicts of interest (unless they are properly released). A director must exercise the care, skill and diligence which would be exercised in the same circumstances by a reasonable person having the knowledge and experience that (a) may reasonably be expected of a person in the same position as the director and (b) which that particular director has. Additional statutory duties include ensuring the maintenance of proper books of account, having annual accounts prepared, having an annual audit performed, the maintenance of certain statutory registers and making certain filings and the disclosure of personal interests. When directors, as agents in transactions, make contracts on behalf of the Company, they generally incur no personal liability under these contracts. It is Trinity Biotech, as principal, which will be liable under these contracts, as long as the directors have acted within Trinity Biotech’s objects and within their own authority. A director who commits a breach of their duties shall be liable to Trinity Biotech for any profit made by them or for any damage suffered by Trinity Biotech as a result of the breach. In addition to the above, a breach by a director of their duties may (where relevant) lead to the summary dismissal of the director, civil or criminal sanction from a Court, including penalties or imprisonment, and/or the imposition of orders restricting or disqualifying the director from acting as a director.
Other than contracts entered into in the ordinary course of business, the following represents the material contracts entered into by the Group:
Credit Agreement and Senior Convertible Note
Our senior secured term loan facility with Perceptive Credit Holdings III, LP is governed by the Sixth Amended and Restated Credit Agreement and Guaranty, dated as of August 7, 2025, as amended on October 16, 2025 and December 22, 2025 and April 30, 2026 (as amended, the “Credit Agreement”). Amendments in 2025 provided additional term loans of US$2.0 million (on August 7, 2025), US$2.0 million (on October 16, 2025) and US$5.0 million (on December 22, 2025). As of December 31, 2025, aggregate outstanding principal of the Term Loans was US$108.0 million.
Interest accrues at a rate equal to Term SOFR plus the applicable margin, subject to a 4.00% SOFR floor. The applicable margin is 8.75% per annum while aggregate Term Loan principal is at least US$50.0 million, stepping down to 5.25% per annum when aggregate principal falls below US$50.0 million. Accrued interest is payable in arrears on scheduled payment dates, except that interest for the periods September 2024 through January 2026 is payable as PIK interest and added to principal.
The December 22, 2025 amendment extended the maturity date to January 15, 2027. The Credit Agreement permits optional prepayments subject to the prepayment premiums set forth therein.
The obligations under the Credit Agreement are secured by substantially all of our property and assets, including our equity interests in our subsidiaries. The Credit Agreement contains financial covenants requiring that we (a) maintain agreed levels of unrestricted cash, which must be held in one or more accounts subject to the security interests of the lender, and (b) achieve specified minimum total revenue requirements for the twelve months preceding each quarter end. In addition, the Credit Agreement contains covenants that restrict our ability to finance future operations or capital needs or to engage in other business activities.
In connection with the December 22, 2025 amendment, we issued a senior convertible note evidencing the Term Loans outstanding under the Credit Agreement at the time. Under the December 22, 2025 Agreements up to US$60.0 million of the aggregate principal amount of the Convertible Note was convertible at the holder’s election into ADSs, at a conversion price of 97% of the VWAP of the ADSs at the time of each such conversion, subject to a floor price of US$1.03 (the “Conversion Price”) and a beneficial ownership cap. The Convertible Note restricts the conversion thereof to the extent that, upon such conversion, the number of the Company’s ordinary shares then beneficially owned by the holder and its “Attribution Parties” (as defined in the Convertible Note), including its affiliates and any other person or entities with which such holder would constitute a Section 13(d) “group,” would exceed 9.9% of the total number of ordinary shares then outstanding (the “Perceptive Beneficial Ownership Cap”).
In connection with the December 22, 2025 amendment, we also entered into a related Conversion Rights Agreement regarding certain WaveForm obligations owed to Perceptive Advisors, as described below.
On April 30, 2026, the Group entered into a third amendment to its Credit Agreement with Perceptive and a related amendment and restatement of the Senior Convertible Note. The amendment to the Credit Agreement provided for, among other things, an additional US$2.5 million term loan borrowing, the payment of certain interest through April 2026 as PIK interest, and a limited waiver of certain financial covenants. In connection with these amendments, the aggregate principal amount of indebtedness subject to conversion was increased from US$60.0 million to US$72.5 million. Under the amended and restated Senior Convertible Note, up to US$72.5 million of the aggregate principal amount of the Convertible Note is convertible, at the holder’s election, into ADSs, at a conversion price of 97% of the VWAP of the ADSs at the time of each such conversion, subject to the minimum conversion price of $0.5061 (equal to 75% of the 30 day VWAP of the Company’s ADSs for the period ended April 22, 2026). This amended conversion price also applies to amounts convertible pursuant to the Conversion Rights Agreement, as described below. All conversions remain subject to the beneficial ownership limitations and other terms and conditions set out in the relevant agreements.
Conversion Rights Agreement
In addition, on December 22, 2025, Trinity Biotech plc and TRIB Biosensors Inc. (“TRIB B”) Perceptive Credit Holdings II, L.P entered into a conversion rights agreement with Perceptive Credit Holdings II, L.P. (the “Conversion Rights Agreement”), pursuant to which we and Perceptive agreed to permit a US$5.0 million payment obligation of TRIB B owed to Perceptive in connection with the Waveform acquistion (the “Milestone Payment Obligation”) to be satisfied, at Perceptive’s election, by converting that obligation (in whole or in part) into our ADSs at the Conversion Price, as defined above, at the time of each such conversion. The Conversion Rights Agreement also provided for the termination of TRIB B’s contingent payment obligation in connection with the Waveform acquisition of up to US$15.0 million in exchange for TRIB B’s agreement to pay US$7.5 million to Perceptive, and the parties’ agreement to permit that obligation to be satisfied (in whole or in part), at Perceptive’s election, by converting such obligation into ADSs at the Conversion Price at the time of each conversion. Perceptive’s ability to convert obligations under the Conversion Rights Agreement is also subject to the Perceptive Beneficial Ownership Cap.
Under the SEPA, the maximum number of ADSs we may elect to sell pursuant to an Advance Notice may not exceed the greater of (i) 100% of the average of the reported daily trading volume of our ADSs on our principal trading market during the five consecutive Trading Days immediately preceding that Advance Notice or (ii) 250,000, unless otherwise mutually agreed in writing. Purchases pursuant to an Advance Notice electing a single day pricing period are also subject to a volume threshold which, if not met, may result in a reduction to the number of ADSs to be purchased to 30% of that days’ trading volume. The SEPA also prohibits us from directing Yorkville to purchase ADSs if those ADSs, when aggregated with all other ADSs or ordinary shares then beneficially owned by the Yorkville and its affiliates, would result in Yorkville and its affiliates beneficially owning more than 4.99% of our then-outstanding ordinary shares.
Warrant agreement with Perceptive Advisors
On December 15, 2021, the Company agreed, subject to drawdown of the Term Loan, to issue warrants exercisable for 500,000 of the Company’s ADSs to Perceptive. The warrants were issued in January 2022 following the drawdown of the term loan. The per ADS exercise price of the Warrants is US$6.50, based on the lower of i) the 10-day volume weighted average price (“VWAP”) for the Company’s ADSs for the 10 business days prior to the Closing Date of the Credit Agreement for the Term Loan and ii) the 10-day VWAP for the Company’s ADSs for the 10 business days prior to the drawdown date of the funding under the Term Loan. The Warrants are exercisable, in whole or part, until the seventh anniversary of the date of drawdown of the funding under the Term Loan.
In February 2023, in connection with an increased Term Loan facility, the Company agreed to reprice the 500,000 warrants, originally issued to Perceptive, to a price of US$5.36 per ADS.
On January 30, 2024, the Company entered into a further amendment to its senior secured term loan credit facility with Perceptive. In connection with the Amended Term Loan, Perceptive received new warrants to purchase an additional 500,000 ADSs.
Additionally, on December 23, 2024, the Company entered into a further amendment to its senior secured term loan credit facility with Perceptive. In connection with the Amended Term Loan, Perceptive received new warrants to purchase an additional 1,500,000 ADSs, and reprice its existing ADS warrants at an exercise price of US$0.80 per ADS.
In August 2025, in connection with the sixth amendment to the senior secured term loan credit facility, Perceptive received new warrants to purchase an additional 750,000 ADSs at an exercise price of US$0.86 per ADS.
Securities Purchase Agreement and Convertible Note related to MiCo Investment
In May 2022, the Company completed a US$45.2 million investment from MiCo IVD Holdings LLP. The investment consisted of an equity investment of approximately US$25.2 million (2.24 million ADSs at a price of US$11.25 per ADS) and a seven-year, unsecured US$20 million junior convertible note, with a fixed interest rate of 1.5% and an ADS conversion price of US$16.20 per ADS. The convertible note mandatorily converts into ADS if the volume weighted average price of the Company’s ADSs is at or above US$16.20 for any five consecutive NASDAQ trading days.
Transition Agreement with Bayer Healthcare LLC
The transition agreement with Bayer Healthcare LLC (“Bayer”) derives from the acquisition of the CGM assets of Waveform Technologies, Inc in January 2024. As a portion of acquired intellectual property was developed originally by Bayer, the transition agreement provides that the Company will pay Bayer a royalty on net sales of the CGM products.
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Asset and share Purchase Agreement for CGM assets of Waveform Technologies, Inc.
On January 30, 2024, the Company acquired the biosensor technology, including the CGM assets, of Waveform for an initial consideration of US$12.5 million in cash and 1.8 million ADSs of the Company plus contingent consideration. The Company intends to initially design an updated CGM sensor using the acquired Waveform assets together with a related data driven health and wellness insights platform and to further evolve the platform technology acquired through the acquisition of the Waveform assets to measure and analyse other valuable biomarkers and related datapoints.
Share Purchase Agreement for Metabolomics Diagnostics Ltd
On September 24, 2024, the Company completed the acquisition of 100% of Metabolomics Diagnostics Limited, for consideration of approximately US$0.9 million paid through the issuance of approximately 0.27 million American Depository Shares (ADS) of the Company alongside the extinguishment of monies owed to the company totalling US$0.4 million. The Company intends to develop and commercialise a screening test for preeclampsia risk using Metabolomics’s Prepsia test.
Share Purchase Agreement for EpiCapture Limited
On October 22, 2024, the Group completed the acquisition of 100% of EpiCapture Limited, for initial consideration of approximately US$3.3 million paid through the issuance of approximately 1.7 million American Depository Shares (ADS) of the Company, with an additional consideration of US$0.5 million contingent on the achievement of future milestones. The Company intends to develop a non-invasive test for monitoring the risk of aggressive prostate cancer.
Share Purchase Agreement in respect of Novus Diagnostics Limited
On September 27, 2024, the Group completed a strategic investment in Novus Diagnostics Limited, acquiring a 12.5% equity stake at that time. The consideration comprised approximately 1.4 million American Depository Shares (ADS) of the Company, valued at approximately US$2.6 million. Novus Diagnostics is developing a rapid, point-of-care test for bloodstream infections, and the investment is expected to support the advancement and commercialization of its sepsis detection platform. A subsequent follow-on investment by another shareholder in 2025 resulted in a minor dilution of the Group’s interest, which remains strategic in nature.
Except as indicated below, there are no restrictions on non-residents of Ireland dealing in Irish securities (including shares or depositary receipts of Irish companies such as the Company). Dividends and redemption proceeds also continue to be freely transferable to non-resident holders of such securities.
As an EU Member State, EU Council Regulations which implement EU and UN sanctions decisions automatically have direct effect in Irish law once they enter into force at EU level. Ireland does not currently operate an autonomous sanctions policy which departs from EU and UN sanctions decisions. At present EU Council Regulations prohibit financial transfers involving a number of persons, entities and bodies, which are subject to amendment on an ongoing, regular basis and currently include, but are not limited to: certain persons and activities in Afghanistan, Belarus, Bosnia & Herzegovina, Burundi, the Central African Republic, Democratic Republic of Congo, the Republic of Guinea, the Republic of Guinea-Bissau, Haiti, the Democratic People's Republic of Korea, Egypt, Eritrea, Iran, Iraq, Lebanon, Libya, Myanmar/Burma, Nicaragua, Russia, Syria, Somalia, South Sudan, Sudan, Tunisia, Turkey, Ukraine, Venezuela, Yemen, and Zimbabwe without the prior permission of the Central Bank of Ireland.
Under the Financial Transfers Act 1992 (the “1992 Act”), the Minister for Finance of Ireland may make provision for the restriction of financial transfers between Ireland and other countries. Financial transfers are broadly defined, and the acquisition or disposal of the ADRs, which represent shares issued by an Irish incorporated company, the acquisition or the disposal of Ordinary Shares and associated payments may fall within this definition. Dividends or payments on the redemption or purchase of shares and payments on the liquidation of an Irish-incorporated company would fall within this definition. Any orders made under the 1992 Act typically align with the EU and UN sanctions decisions as Ireland does not operate an autonomous sanctions policy at present.
Any transfer of, or payment in respect of, an ADS involving the government of any country that is currently the subject of EU or UN sanctions, any person or body controlled by any of the foregoing, or any person acting on behalf of the foregoing, may be subject to restrictions pursuant to such sanctions as implemented into Irish law. The Company does not anticipate that orders made under the 1992 Act or EU or UN sanctions implemented into Irish law will have a material effect on its business.
The following discussion is based on U.S. and Republic of Ireland tax law, statutes, treaties, regulations, rulings and decisions all as of the date of this annual report. Taxation laws are subject to change, from time to time, and no representation is or can be made as to whether such laws will change, or what impact, if any, such changes would have on the statements contained in this summary. No assurance can be given that proposed amendments will be enacted as proposed, or that legislative or judicial changes, or changes in administrative practice, will not modify or change the law as described herein.
This summary is of a general nature only. It does not constitute legal or tax advice nor does it discuss all aspects of Irish taxation that may be relevant to any particular Irish Holder or U.S. Holder of ordinary shares or ADSs.
This summary does not discuss all aspects of Irish and U.S. federal income taxation that may be relevant to a particular holder of Trinity Biotech ADSs in light of the holder’s own circumstances or to certain types of investors subject to special treatment under applicable tax laws (for example, financial institutions, life insurance companies, tax-exempt organisations, and non-U.S. taxpayers) and it does not discuss any tax consequences arising under the laws of taxing jurisdictions other than the Republic of Ireland and the U.S. federal government. The tax treatment of holders of Trinity Biotech ADSs may vary depending upon each holder’s own particular situation.
Prospective purchasers of Trinity Biotech ADSs are advised to consult their own tax advisors as to the US, Irish or other tax consequences of the purchase, ownership and disposition of such ADSs.
U.S. Federal Income Tax Consequences to U.S. Holders
The following is a summary of certain material U.S. federal income tax consequences that generally would apply with respect to the ownership and disposition of Trinity Biotech ADSs, in the case of a holder of such ADSs who is a U.S. Holder (as defined below) and who holds the ADSs as capital assets. This summary is based on the U.S. Internal Revenue Code of 1986, as amended (the “Code”), Treasury Regulations promulgated thereunder, and judicial and administrative interpretations thereof, all as in effect on the date hereof and all of which are subject to change either prospectively or retroactively. For the purposes of this summary, a U.S. Holder is: an individual who is a citizen or tax resident of the U.S.; a corporation created or organised in or under the laws of the U.S. or any political subdivision thereof; an estate whose income is subject to U.S. federal income tax regardless of its source; or a trust that (a) is subject to the primary supervision of a court within the U.S. and control by one or more U.S. persons or (b) has a valid election in effect under applicable U.S. Treasury regulations to be treated as a U.S. person.
This summary does not address all tax considerations that may be relevant with respect to an investment in ADSs. This summary does not discuss all the tax consequences that may be relevant to a U.S. Holder in light of such Holder’s particular circumstances or to U.S. Holders or other persons subject to special rules, including persons that are not U.S. Holders, broker dealers, financial institutions, certain insurance companies, investors liable for alternative minimum tax, tax exempt organisations, regulated investment companies, non-resident aliens of the U.S. or taxpayers whose functional currency is not the U.S. Dollar, persons who hold ADSs through partnerships or other pass-through entities, persons who acquired their ADSs through the exercise or cancellation of employee stock options or otherwise as compensation for services, investors that actually or constructively own 10% or more of Trinity Biotech’s shares by vote or value, and investors holding ADSs as part of a straddle or appreciated financial position or as part of a hedging or conversion transaction.
If an entity treated as a partnership for U.S. federal income tax purposes owns ADSs, the U.S. federal income tax treatment of a partner in such a partnership will generally depend upon the status of the partner and the activities of the partnership. The partners in a partnership that owns ADSs should consult their tax advisors about the U.S. federal income tax consequences of holding and disposing of ADSs.
This summary does not address the effect of any U.S. federal taxation other than U.S. federal income taxation. In addition, this summary does not include any discussion of state, local or foreign taxation. You are urged to consult your tax advisors regarding the foreign and U.S. federal, state and local tax considerations of an investment in ADSs.
For U.S. federal income tax purposes, U.S. Holders of Trinity Biotech ADSs will be treated as owning the underlying Class ‘A’ Ordinary Shares represented by the ADSs held by them. This discussion assumes such treatment is respected.
Dividends and Other Distributions on ADSs
The gross amount of any distribution made by Trinity Biotech to U.S. Holders with respect to the underlying shares represented by the ADSs held by them, including the amount of any Irish taxes withheld from such distribution, will be treated for U.S. federal income tax purposes as a dividend to the extent of Trinity Biotech’s current and accumulated earnings and profits, as determined for U.S. federal income tax purposes. The amount of any such distribution that exceeds Trinity Biotech’s current and accumulated earnings and profits will be applied against and reduce a U.S. Holder’s tax basis in the U.S. Holder’s ADSs, and any amount of the distribution remaining after the U.S. Holder’s tax basis has been reduced to zero will constitute capital gain. However, there can be no assurances we will calculate earnings and profits under U.S. federal income tax principles. Therefore, any distribution we make to you may be reported as a dividend. The capital gain will be treated as a long-term or short-term capital gain depending on whether or not the U.S. Holder’s ADSs have been held for more than one year as of the date of the distribution.
Dividends paid by Trinity Biotech generally will not qualify for the dividends received deduction otherwise available to U.S. corporate shareholders.
Subject to complex limitations, any Irish withholding tax imposed on dividends will be a foreign income tax eligible for credit against a U.S. Holder’s U.S. federal income tax liability (or, alternatively, for deduction against income in determining such tax liability) where certain conditions are satisfied. The limitations set out in the Code include computational rules under which foreign tax credits allowable with respect to specific classes of income, commonly referred to as “baskets,” cannot exceed the U.S. federal income taxes otherwise payable with respect to each such class of income. Dividends generally will be treated as foreign-source passive category income or, in the case of certain U.S. Holders, general category income for U.S. foreign tax credit purposes. Further, there are special rules for computing the foreign tax credit limitation of a taxpayer who receives dividends subject to a reduced tax, see discussion below.
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A U.S. Holder will be denied a foreign tax credit with respect to Irish income tax withheld from dividends received on the ADSs to the extent such U.S. Holder has not held the ADSs for at least 16 days of the 31-day period beginning on the date which is 15 days before the ex-dividend date, or to the extent such U.S. Holder is under an obligation to make related payments with respect to substantially similar or related property. Any days during which a U.S. Holder has substantially diminished its risk of loss on the ADSs are not counted toward meeting the 16-day holding period required by the Code. If a refund of the tax withheld is available to you under the laws of Ireland or under the United States and Ireland income tax treaty (the “Treaty”), the amount of tax withheld that is refundable will not be eligible for such credit against your U.S. federal income tax liability (and will not be eligible for the deduction against your U.S. federal taxable income). The rules relating to the determination of the foreign tax credit are complex, and you should consult with your personal tax advisors to determine whether and to what extent you would be entitled to this credit against your U.S. federal income tax liability.
Subject to certain limitations, including the PFIC rules discussed below, “qualified dividend income” received by a noncorporate U.S. Holder will be subject to tax at lower rates. Distributions taxable as dividends paid on the ADSs should qualify as qualified dividend income provided that either: (i) we are entitled to benefits under the Treaty or (ii) the ADSs are readily tradable on an established securities market in the U.S. and certain other requirements are met. We believe that we are entitled to benefits under the Treaty and that the ADSs currently are readily tradable on an established securities market in the U.S. However, no assurance can be given that the ADSs will remain readily tradable. The rate reduction does not apply unless certain holding period requirements are satisfied. With respect to the ADSs, the U.S. Holder must have held such ADSs for at least 61 days during the 121-day period beginning 60 days before the ex-dividend date. The rate reduction also does not apply to dividends received from passive foreign investment companies, see discussion below, or in respect of certain hedged positions or in certain other situations. The legislation enacting the reduced tax rate contains special rules for computing the foreign tax credit limitation of a taxpayer who receives dividends subject to the reduced tax rate. U.S. Holders of ADSs should consult their own tax advisors regarding the effect of these rules in their particular circumstances.
Dispositions of the ADSs
Upon a sale or exchange of ADSs, a U.S. Holder will recognise a gain or loss for U.S. federal income tax purposes in an amount equal to the difference between the amount realised on the sale or exchange and the U.S. Holder’s adjusted tax basis in the ADSs sold or exchanged. Such gain or loss generally will be capital gain or loss and will be long-term or short-term capital gain or loss depending on whether the U.S. Holder has held the ADSs sold or exchanged for more than one year at the time of the sale or exchange. If you are a non-corporate U.S. Holder, long-term capital gains may be eligible for reduced tax rates.
Passive Foreign Investment Company
For U.S. federal income tax purposes, a foreign corporation is treated as a “passive foreign investment company” (or “PFIC”) in any taxable year in which, after taking into account the income and assets of the corporation and certain of its subsidiaries pursuant to the applicable “look through” rules, either (1) at least 75% of the corporation’s gross income is passive income or (2) at least 50% of the average value of the corporation’s assets is attributable to assets that produce passive income or are held for the production of passive income. Based on the nature of its present business operations, assets and income, Trinity Biotech believes that for the year 2024, it was not a PFIC. However, no assurance can be given that changes will not occur in Trinity Biotech’s business operations, assets and income that might cause it to be treated as a PFIC at some future time.
If Trinity Biotech were to become a PFIC, a U.S. Holder of ADSs would be required to allocate to each day in the holding period for such U.S. Holder’s ADSs a pro rata portion of any distribution received (or deemed to be received) by the U.S. Holder from Trinity Biotech, to the extent the distribution so received constitutes an “excess distribution,” as defined under U.S. federal income tax law. Generally, a distribution received during a taxable year by a U.S. Holder with respect to the underlying shares represented by any of the U.S. Holder’s ADSs would be treated as an “excess distribution” to the extent that the distribution so received, plus all other distributions received (or deemed to be received) by the U.S. Holder during the taxable year with respect to such underlying shares, is greater than 125% of the average annual distributions received by the U.S. Holder with respect to such underlying shares during the three preceding years (or during such shorter period as the U.S. Holder may have held the ADSs). Any portion of an excess distribution that is treated as allocable to one or more taxable years prior to the year of distribution during which Trinity Biotech was classified as a PFIC would be subject to U.S. federal income tax at the highest tax rate applicable to the U.S. Holder in the prior tax year or years to which it is allocated. The U.S. Holder also would be subject to an interest charge, in the year in which the excess distribution is made, on the amount of taxes deemed under the PFIC rules to have been deferred with respect to the excess distribution. In addition, any gain recognised on a sale or other disposition of a U.S. Holder’s ADSs, including any gain recognised on a liquidation of Trinity Biotech, would be treated in the same manner as an excess distribution. Any such gain would be treated as ordinary income rather than as capital gain.
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If Trinity Biotech became a PFIC, a U.S. Holder may be eligible to make a “qualifying electing fund” (or “QEF”) election in the year Trinity Biotech first becomes a PFIC or in the year the U.S. Holder acquires the ADSs, whichever is later. This election provides for a current inclusion of Trinity Biotech’s ordinary income and capital gain income in the U.S. Holder’s U.S. taxable income. In return, any gain on sale or other disposition of a U.S. Holder’s ADSs in Trinity Biotech, if it were classified as a PFIC, would be treated as capital, and the interest penalty would not be imposed. This election is not made by Trinity Biotech, but by each U.S. Holder. In order for the U.S. Holder to maintain the election, Trinity Biotech must make available certain information, which Trinity Biotech may choose not to provide. U.S. Holders should contact their tax advisor for further information about the election.
Alternatively, if the ADSs are considered “marketable stock” a U.S. Holder may elect to “mark-to-market” its ADSs, and such U.S. Holder would not be subject to the PFIC rules described above. Instead, such U.S. Holder would generally include in income any excess of the fair market value of the ADSs at the close of each tax year over its adjusted basis in the ADSs. If the fair market value of the ADSs had fallen below the U.S. Holder’s adjusted basis at the close of the tax year, the U.S. Holder may generally deduct the excess of the adjusted basis of the ADSs over its fair market value at that time. However, such deductions generally would be limited to the net mark-to-market gains, if any, that the U.S. Holder included in income with respect to such ADSs in prior years. Income recognised and deductions allowed under the mark-to-market provisions, as well as any gain or loss on the disposition of ADSs with respect to which the mark-to-market election is made, is treated as ordinary income or loss (except that loss is treated as capital loss to the extent the loss exceeds the net mark-to-market gains, if any, that a U.S. Holder included in income with respect to such ADSs in prior years). However, gain or loss from the disposition of ADSs (as to which a “mark-to-market” election was made) in a year in which Trinity Biotech is no longer a PFIC, will be capital gain or loss. The ADSs should be considered “marketable stock” if they traded at least 15 days during each calendar quarter of the relevant calendar year in more than de minimis quantities.
If a U.S. Holder owns ADSs during any year in which we are a PFIC, the U.S. Holder generally must file an IRS Form 8621 with respect to Trinity Biotech, generally with the U.S. Holder’s federal income tax return for that year.
Information Reporting and Backup Withholding
Distributions made with respect to underlying shares represented by ADSs and proceeds from the sale, exchange or other disposition of ADSs may be subject to information reporting to the IRS and to US backup withholding tax. Backup withholding will not apply, however, if the U.S. Holder (i) is a corporation or comes within certain exempt categories, and demonstrates its eligibility for exemption when so required, or (ii) furnishes a correct taxpayer identification number and makes any other required certification.
Backup withholding is not an additional tax. Amounts withheld under the backup withholding rules may be credited against a U.S. Holder’s U.S. tax liability, and a U.S. Holder may obtain a refund of any excess amounts withheld under the backup withholding rules by filing the appropriate claim for refund with the IRS.
Information with Respect to Foreign Financial Assets
U.S. persons that hold certain specified foreign financial assets, including stock in a foreign corporation, with values in excess of certain thresholds are required to file with their U.S. federal income tax return Form 8938, on which information about the assets, including their value, is provided. Taxpayers who fail to file the form when required are subject to penalties. An exemption from reporting applies to foreign assets held through certain financial institutions. Investors are encouraged to consult with their own tax advisors regarding the possible application of this disclosure requirement to their investment in ADSs.
Medicare Contribution Tax
In addition to the income taxes described above, U.S. Holders that are individuals, estates or trusts and whose income exceeds certain thresholds will be subject to a 3.8% Medicare contribution tax on net investment income, which includes dividends and capital gains.
U.S. Holders may be subject to state or local income and other taxes with respect to their purchase, ownership and disposition of ADSs. U.S. Holders of ADSs should consult their own tax advisers as to the applicability and effect of any such taxes.
Irish Taxation
For the purposes of this summary, an “Irish Holder” means a holder of ordinary shares or ADSs evidenced by ADSs that (i) beneficially owns the ordinary shares or ADSs registered in its name; (ii) in the case of individual holders, are resident, ordinarily resident and domiciled in Ireland under Irish taxation laws; (iii) in the case of holders that are companies, are resident in Ireland under Irish taxation laws; and (iv) are not also resident in any other country under any double taxation agreement entered into by Ireland.
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For Irish taxation purposes, Irish Holders of ADSs are effectively treated as the owners of the underlying ordinary shares represented by such ADSs.
Solely for the purposes of this summary of Irish Tax considerations, a “U.S. Holder” means a holder of ordinary shares or ADSs evidenced by ADSs that (i) beneficially owns the ordinary shares or ADSs registered in its name; (ii) is resident in the United States for the purposes of the Republic of Ireland/United States Double Taxation Convention (the Treaty); (iii) in the case of an individual holder, is not also resident or ordinarily resident in Ireland for Irish tax purposes; (iv) in the case of a corporate holder, is not a resident in Ireland for Irish tax purposes and is not ultimately controlled by persons resident in Ireland; and (v) is not engaged in any trade or business in Ireland and does not perform independent personal services through a permanent establishment or fixed base in Ireland.
In 2011, the Board decided that it was an appropriate time to commence a dividend policy for the first time in the Company’s history, but the payment of dividends has subsequently been suspended (see section below on Dividend Policy). The payment of a dividend is generally subject to dividend withholding tax (“DWT”) at the standard rate of income tax in force at the time. The current DWT rate is 25% in respect of dividends paid on or after 1 January 2020. Under current legislation, where DWT applies, Trinity Biotech will be responsible for withholding it at source and paying it to the Irish Revenue.
DWT will not be withheld where an exemption applies and where Trinity Biotech has received all necessary documentation from the recipient prior to payment of the dividend.
Corporate Irish Holders will generally be entitled to claim an exemption from DWT by delivering a declaration, which confirms that the company is resident in Ireland for tax purposes, to Trinity Biotech in the form prescribed by the Irish Revenue Commissioners. Such corporate Irish Holders will generally not otherwise be subject to Irish tax in respect of dividends received.
Individual Irish Holders may, depending on their individual circumstance, be subject to income tax on the gross amount of any dividend (that is the amount of the dividend received plus any DWT withheld), at their marginal rate of income tax, currently either 20% or 40% depending on the individual’s circumstances, as well as Pay Related Social Insurance (“PRSI”) of up to 4.2% and the Universal Social Charge up to 11% (“USC”). Individual Irish Holders will be able to claim a credit against their resulting income tax liability and USC liability in respect of DWT withheld.
Under the Irish Taxes Consolidation Act 1997, dividends paid by Trinity Biotech to non-Irish shareholders will, unless exempted, be subject to DWT. Such non-Irish shareholders will not suffer DWT on dividends if the shareholder is:
an individual resident in the U.S. (or certain other countries with which Ireland has a double taxation treaty) and who is neither resident nor ordinarily resident in Ireland; or
a U.S. tax resident corporation (or a corporation resident in certain other countries, with which Ireland has a double taxation treaty) not under the control of Irish residents; or
a corporation that is not resident in Ireland and which is ultimately controlled by persons resident in the U.S. (or certain other countries with which Ireland has a double taxation treaty), with such person or persons not under the control of persons who are not so resident; or
a corporation that is not resident in Ireland and the principal class of whose shares (or its 75% parent’s principal class of shares) is substantially or regularly traded on a recognised stock exchange in Ireland or a country with which Ireland has a double taxation treaty; or
is otherwise entitled to an exemption from DWT.
In order to avail of the above exemption, certain declarations must be made in advance to the paying company.
A self-assessment system applies to a person tax resident in a treaty jurisdiction receiving dividends, under which a non-resident person must provide a declaration and certain information to the dividend paying company or intermediary to claim the exemption.
Special DWT arrangements are available in the case of shares in Irish companies held by U.S. resident holders through American depository banks using ADSs where such banks enter into intermediary agreements with Irish Revenue and are viewed as qualifying intermediaries under Irish Tax legislation. Under such agreements, American depository banks who receive dividends from Irish companies and pay the dividends on to the U.S. resident ADS holders are allowed to receive and pass on a dividend from the Irish company on a gross basis (without any withholding) if:
the recipient is the direct beneficial owner of the shares, and
the recipient is the direct beneficial owner of the ADSs, and the depository bank’s ADS register shows that the direct beneficial owner of the dividends has a U.S. address on the register, and
there is an intermediary between the depository bank and the shareholder beneficially entitled to the dividend and the depository bank receives confirmation from the intermediary that such shareholder’s address in the intermediary’s records is in the U.S.
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Where the above procedures have not been complied with and DWT is withheld from dividend payments to U.S. Holders of ordinary shares or ADSs evidenced by ADSs, such U.S. Holders can apply to Irish Revenue claiming a full refund of DWT paid by filing a declaration / claim in the form prescribed by Irish Revenue. Certain accompanying information should also be included when making such claims.
The DWT rate applicable to U.S. Holders is reduced to 5% under the terms of the Treaty for corporate U.S. Holders holding 10% or more of voting shares and to 15% for other U.S. Holders. While this will, subject to the application of Article 23 of the Treaty, generally entitle U.S. Holders to claim a partial refund of DWT from the Irish Revenue Commissioners, U.S. Holders will, in most circumstances, likely prefer to seek a full refund of DWT under Irish domestic legislation (see above).
Disposals of Ordinary Shares or ADSs
Irish Holders that acquire ordinary shares or ADSs will generally be considered, for Irish tax purposes, to have acquired their ordinary shares or ADSs at a base cost equal to the amount paid for the ordinary shares or ADSs. On subsequent dispositions, ordinary shares or ADSs acquired at an earlier time will generally be deemed, for Irish tax purposes, to be disposed of on a “first in first out” basis before ordinary shares or ADSs acquired at a later time (unless the ordinary shares or ADSs were acquired within four weeks prior to the disposition). Irish Holders that dispose of their ordinary shares or ADSs will be subject to Irish capital gains tax (“CGT”) to the extent that the proceeds realised from such dispositions exceed the indexed base cost of the ordinary shares or ADSs disposed of and any incidental expenses. The current rate of CGT is 33% and this applies to disposals made on or after 6 December 2012. Indexation of the base cost of the ordinary shares or ADSs is available up to 31 December 2002, and only in respect of ordinary shares or ADSs held for more than 12 months prior to their disposal.
Irish Holders that have unutilised capital losses from other sources in the current, or any previous tax year, can generally apply such losses to reduce gains realised on the disposal of the ordinary shares or ADSs.
An annual exemption allows individuals to realise chargeable gains of up to €1,270 in each tax year without giving rise to CGT. This exemption is specific to the individual and cannot be transferred between spouses. Irish Holders are required, under Ireland’s self-assessment system, to file tax returns reporting any chargeable gains arising to them in a particular tax year.
Where disposal proceeds are received in a currency other than Euro, they must be translated into Euro amounts to calculate the amount of any chargeable gain or loss. Similarly, acquisition costs denominated in a currency other than Euro must be translated at the date of acquisition into Euro amounts.
Irish Holders that realise a loss on the disposal of ordinary shares or ADSs will generally be entitled to offset such allowable losses against capital gains realised from other sources in determining their CGT liability in that year. Allowable losses which remain unrelieved in a year may generally be carried forward indefinitely for CGT purposes and applied against capital gains in future years.
Transfers between spouses who live together will not give rise to any chargeable gain or loss for CGT purposes with the acquiring spouse acquiring the same pro rata base cost and acquisition date as that of the transferring spouse.
U.S. Holders will not be subject to Irish CGT on the disposal of ordinary shares or ADSs provided that such ordinary shares or ADSs are quoted on a stock exchange at the time of disposition. The stock exchange for this purpose is the Nasdaq Global Market (“NASDAQ”). While it is our intention to continue the quotation of ADSs on NASDAQ, no assurances can be given in this regard.
If, for any reason, our ADSs cease to be quoted on the NASDAQ, U.S. Holders will not be subject to CGT on the disposal of their ordinary shares or ADSs provided that the ordinary shares or ADSs do not, at the time of the disposal, derive the greater part of their value from land, buildings, minerals, or mineral rights or exploration rights in Ireland.
A gift or inheritance of ordinary shares will be, or in the case of ADSs may be, within the charge to capital acquisitions tax, regardless of where the disponer or the donee/successor in relation to the gift/inheritance is domiciled, resident or ordinarily resident. Capital acquisitions tax is levied at a rate of 33% on the taxable value of the gift or inheritance above certain tax-free thresholds and this rate applies in respect of gifts and inheritances taken on or after 6 December 2012. The tax-free threshold is determined by the amount of the current benefit and of previous benefits received within the group threshold since 5 December 1991, which are within the charge to capital acquisitions tax and the relationship between the former holder and the successor. Gifts and inheritances between spouses are not subject to the capital acquisitions tax. Gifts of up to €3,000 can be received each year from any given individual without triggering a charge to capital acquisitions tax. Where a charge to Irish CGT and capital acquisitions tax arises on the same event, capital acquisitions tax payable on the event can be reduced by the amount of the CGT payable. There should be no clawback of the same event credit of CGT offset against capital acquisitions tax provided the donee does not dispose of the ordinary shares or ADSs within two years from the date of gift.
The Estate Tax Convention between Ireland and the United States generally provides for Irish capital acquisitions tax paid on inheritances in Ireland to be credited, in whole or in part, against tax payable in the United States, in the case where an inheritance of ordinary shares or ADSs is subject to both Irish capital acquisitions tax and U.S. federal estate tax. The Estate Tax Convention does not apply to Irish capital acquisitions tax paid on gifts.
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Irish stamp duty, which is a tax imposed on certain documents, is payable on all transfers of ordinary shares of an Irish registered company (other than transfers made between spouses, transfers made between 90% associated companies, or certain other exempt transfers) regardless of where the document of transfer is executed. Irish stamp duty is also payable on electronic transfers of ordinary shares. A transfer of ordinary shares made as part of a sale or gift will generally be stampable at the ad valorem rate of 1% of the value of the consideration received for the transfer, or, if higher, the market value of the shares transferred. With effect from 9 October 2019, stamp duty at a rate of 7.5% applies in certain circumstances to the sale or transfer of shares which derive their value, or the greater part of their value, from non-residential property in Ireland. Any instrument executed on or after 24 December 2008, which transfers stock or marketable securities on sale where the amount or value of the consideration is €1,000 or less may be exempt from stamp duty. Where the consideration for a sale is expressed in a currency other than Euro, the duty will be charged on the Euro equivalent calculated at the rate of exchange prevailing at the date of the transfer.
Transfers of ordinary shares where no beneficial interest passes (e.g. a transfer of shares from a beneficial owner to a nominee) will generally be exempt from stamp duty provided the transfer is not made in contemplation of sale.
Transfers of ADSs are exempt from Irish stamp duty as long as the ADSs are quoted on any recognised stock exchange in the U.S. or Canada. Finance Act 2023 introduced an exemption for any electronic transfers of interests in Irish shares within central securities depositories in either the USA or Canada, where the aforementioned shares are dealt in on a recognised stock exchange in either of those countries and the trade is settled through a securities settlement system located in the US or Canada. Prior to Finance Act 2023, this exemption was available by way of an administrative practice and taxpayers were required to seek Irish Revenue confirmation on a case-by-case basis as to whether this exemption applied.
Transfers of ordinary shares from the Depositary or the Depositary’s custodian upon surrender of ADSs for the purposes of withdrawing the underlying ordinary shares from the ADS system, and transfers of ordinary shares to the Depositary or the Depositary’s custodian for the purposes of transferring ordinary shares onto the ADS system, will be stampable at the ad valorem rate of 1% of the value of the shares if there is a transfer of beneficial ownership or the transfer is made in contemplation of sale. Such transfers will be exempt from Irish stamp duty if the transfer does not involve any change in the beneficial ownership in the underlying ordinary shares and the transfer is not made in contemplation of a sale. The person accountable for the payment of stamp duty is the transferee or, in the case of a transfer by way of gift or for consideration less than the market value, both parties to the transfer. Stamp duty is normally payable within 44 days after the date of execution of the transfer. Late or inadequate payment of stamp duty may result in liability for interest, penalties, surcharge and fines.
We are subject to the reporting requirements of the Exchange Act, as applicable to “foreign private issuers” as defined in Rule 3b-4 under the Exchange Act, and in accordance therewith, we file reports and other information with the SEC, including annual reports on Form 20-F and reports on Form 6-K.
As a foreign private issuer, we are exempt from certain provisions of the Exchange Act. Accordingly, our proxy solicitations are not subject to the disclosure and procedural requirements of Regulation 14A under the Exchange Act. In addition, while our officers and directors are subject to the beneficial ownership reporting requirements of Section 16(a) of the Exchange Act, they remain exempt from the “short-swing” profit recovery provisions of Section 16(b) and the short sale restrictions of Section 16(c) of the Exchange Act.
In addition, we are not required under the Exchange Act to file periodic reports and financial statements as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act.
The SEC maintains an internet website that contains reports and other information regarding issuers that file electronically with the SEC. This annual report and the exhibits thereto and any other document we file pursuant to the Exchange Act may be viewed on the SEC’s website at www.sec.gov and on our website at www.trinitybiotech.com. The information contained on our website is not incorporated by reference into this Annual Report.
The documents concerning our Company which are referred to in this Annual Report may also be inspected at our offices located at IDA Business Park, Bray, County Wicklow, Ireland.
Item 11. Quantitative and Qualitative Disclosures about Market Risk
Quantitative information about Market Risk
Interest rate sensitivity
Trinity Biotech monitors its exposure to changes in interest and exchange rates by estimating the impact of possible changes on reported profit before tax and net worth. The Group accepts interest rate and currency risk as part of the overall risks of operating in different economies and seeks to manage these risks by following the policies set above.
Trinity Biotech estimates that the maximum effect of a rise of one percentage point in one of the principal variable interest rates to which the Group is exposed would be an increase in the loss before tax for December 31, 2025 by approximately 3.0%.
Exchange rate sensitivity
At year-end 2025, the total net liability denominated in currencies other than the US Dollar, principally the Euro, Brazilian Real, Canadian Dollar, Swedish Krona and Great British Pound was US$20.5 million.
A strengthening or weakening of the US Dollar by 10% against all the other currencies in which the Group operates, would have the approximate effect of increasing or reducing the Group’s 2025 year-end net worth by approximately US$2.1 million.
Qualitative information about Market Risk
Trinity Biotech’s treasury policy is to manage financial risks arising in relation to or as a result of underlying business needs. The activities of the treasury function, which does not operate as a profit centre, are carried out in accordance with board approved policies and are subject to regular internal review. These activities include the Group making use of spot and forward foreign exchange markets.
Trinity Biotech uses a range of financial instruments (including cash, and finance leases) to fund its operations. These instruments are used to manage the liquidity of the Group in a cost effective, low-risk manner. Working capital management is a key additional element in the effective management of overall liquidity. Trinity Biotech does not trade in financial instruments or derivatives.
The main risks arising from the utilisation of these financial instruments are interest rate risk, liquidity risk and foreign exchange risk.
Trinity Biotech’s reported net income and net assets are all affected by movements in foreign exchange rates.
At December 31, 2025 the Group’s borrowings were at a mixture of variable and fixed rates of interest. The senior secured term loan accrues interest at an annual rate equal to 8.75% plus the greater of (a) the Term SOFR Reference Rate and (b) 4% per annum. The exchangeable notes are at a fixed rate of interest of 4% and the convertible note is at a fixed rate of interest of 1.5%. At December 31, 2025 the carrying value of the Group’s indebtedness totalled US$124,555,000 (2024: US$88,002,000) at interest rates of 1.5% to 12.75%.
In broad terms, a one-percentage point increase in interest rates would increase interest expense by US$1,080,000 (2024: increase in interest expense of US$724,000).
The majority of the Group’s activities are conducted in US Dollars. The primary foreign exchange risk arises from the fluctuating value of the Group’s Euro and Brazilian Real denominated expenses as a result of the movement in the exchange rate between the US Dollar and those currencies. The Group did not engage in foreign currency hedging in 2025.
The Group had foreign currency denominated cash balances equivalent to US$1,106,000 at December 31, 2025 (2024: US$851,000).
Item 12. Description of Securities Other than Equity Securities
Debt Securities
Warrants and Rights
In February 2024, the Company adjusted its ADS ratio from 1 ADS: 4 ordinary shares to 1 ADS: 20 ordinary shares. The ADS numbers shown hereunder reflect the revised ADS ratio.
On December 15, 2021, the Company agreed to issue warrants exercisable for 500,000 of the Company’s ADSs to Perceptive. The warrants were issued in January 2022 following the drawdown of the term loan. The per ADS exercise price of the Warrants was US$6.50. The warrants are exercisable, in whole or part, until the seventh anniversary of the date of drawdown of the funding under the Term Loan. In February 2023, in connection with an increased Term Loan facility, the Company agreed to reprice the 500,000 warrants originally issued to Perceptive to an exercise price of US$5.36 per ADS.
Additionally, on December 23, 2024, the Company entered into a further amendment to its senior secured term loan credit facility with Perceptive. In connection with the Amended Term Loan, Perceptive received new warrants to purchase an additional 1,500,000 ADSs at an exercise price of US$0.80 per ADS, and the exercise price of its existing ADS warrants was also reset to US$0.80 per ADS.
Also on January 30, 2024, the Company issued warrants to a consultant assisting with our CGM business to purchase 60,000 ADSs with an exercise price of US$2.20 per ADS. The warrants are exercisable, in whole or part, until the fifth anniversary of the issue date.
Other Securities
American Depositary Shares
Set forth below is a summary of certain provisions in relation to charges and other payments under the Deposit Agreement with the Bank of New York Mellon, as depositary, and the owners and holders from time to time of ADSs issued thereunder.
Fees and Charges Payable by ADS Holders
The table below summarizes the fees and charges that a holder of our ADSs may have to pay, directly or indirectly, to our depositary, The Bank of New York Mellon, pursuant to the deposit agreement (filed with the SEC on January 15, 2004 as an exhibit to our Form F-6, registration no. 333-111946) and the types of services and the amount of the fees or charges paid for such services. The actual fees payable by Trinity Biotech and the holders of ADSs are negotiated between Trinity Biotech and the depositary. In connection with these arrangements, Trinity Biotech has agreed to pay various fees and expenses of the depositary.
The fees and charges that an ADS holder may be required to pay can be changed in the future upon mutual agreement between Trinity Biotech and by the depositary and may include:
Service
Rate
By whom paid
(1) Issuance of ADSs upon deposit of ordinary shares.
Up to $10.00 per 100 ADSs (or portion thereof) issued.
Persons depositing ordinary shares or person receiving ADSs.
(2) Delivery of deposited securities against surrender of ADSs.
Persons surrendering ADSs for the purpose of withdrawal of deposited securities or persons to whom deposited securities are delivered.
(3) Issuance of ADSs in connection with a distribution of shares.
Person to whom distribution is made.
(4) Distribution of cash dividends or other cash distributions, including distribution of cash proceeds following the sale of rights, shares or other property in accordance with the deposit agreement
Up to $0.02 per 1 ADS
(5) Transfer of ADSs
Up to $1.50 per certificate for ADRs or ADRs transferred
Person to whom Receipt is transferred.
In addition, ADS holders are responsible for certain fees and expenses incurred by the depositary and certain taxes and governmental charges such as:
transfer and registration fees of securities on Trinity Biotech’s securities register to or from the name of the depositary or its agent when ADS holders deposit or withdrawal securities;
expenses for cable, telex and fax transmissions and for delivery of securities;
expenses incurred for converting foreign currency into U.S. dollars; and
taxes and duties upon the transfer of securities (i.e., when ordinary shares are deposited or withdrawn from deposit, other than taxes for which Trinity Biotech is liable).
Depositary fees payable upon the issuance and cancellation of ADSs are typically paid to the depositary by the brokers (on behalf of their clients) receiving the newly issued ADSs from the depositary and by the brokers (on behalf of their clients) delivering the ADSs to the depositary for cancellation. The brokers in turn charge these fees to their clients. Depositary fees payable in connection with distributions of cash or securities to ADS holders and the depositary services fee are charged by the depositary to the holders of record of ADSs as of the applicable ADS record date.
The Depositary fees payable for cash distributions are generally deducted from the cash being distributed. In the case of distributions other than cash (e.g., stock dividend, rights), the depositary charges the applicable fee to the ADS record date holders concurrent with the distribution. In the case of ADSs registered in the name of the investor, the depositary sends invoices to the applicable record date ADS holders. In the case of ADSs held in brokerage and custodian accounts (via DTC), the depositary generally collects its fees through the systems provided by DTC (whose nominee is the registered holder of the ADSs held in DTC) from the brokers and custodians holding ADSs in their DTC accounts. The brokers and custodians who hold their clients’ ADSs in DTC accounts in turn charge their clients’ accounts the amount of the fees paid to the depositary.
In the event of refusal to pay taxes or other governmental charges by the holder of an ADS, the depositary may, under the terms of the deposit agreement, refuse the requested service until payment is received or may set off the amount of such tax or other governmental charge from any distribution to be made to the ADS holder, and the ADS holder would remain liable for any deficiency. The disclosure under this heading “Fees and Charges Payable by ADS Holders” is subject to and qualified in its entirety by reference to the full text of the Deposit Agreement.
On February 15, 2024, Trinity Biotech Plc finalized a ratio change of our American depositary shares (“ADSs”) from one (1) ADS representing four (4) Class A ordinary shares to one (1) ADS representing twenty (20) Class A ordinary shares. The change in ADS ratio will have the same effect as a one-for-five reverse ADS split.
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Part II
Item 13.
Item 14.
Material Modifications to the Rights of Security Holders and Use of Proceeds
Item 15.
Evaluation of Disclosure Controls and Procedures
The Group’s disclosure and control procedures are designed so that information required to be disclosed in reports filed or submitted under the Securities Exchange Act 1934 is prepared and reported on a timely basis and communicated to management, to allow timely decisions regarding required disclosure. Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, have evaluated the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15(d) of the Securities Exchange Act of 1934 as of the end of the period covered by this Form 20-F. The Chief Executive Officer and Chief Financial Officer have concluded that disclosure controls and procedures were effective as of December 31, 2025.
In designing and evaluating our disclosure controls and procedures, our management, with the participation of the Chief Executive Officer and Chief Financial Officer, recognised that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgement in evaluating the cost-benefit relationship of possible controls and procedures. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Group have been detected.
Management’s Annual Report on Internal Control over Financial Reporting
The management of Trinity Biotech are responsible for establishing and maintaining adequate internal control over financial reporting. Trinity Biotech’s internal control over financial reporting is a process designed under the supervision and with the participation of the principal executive and principal financial officers to provide reasonable assurance regarding the reliability of financial reporting and preparation of Trinity Biotech’s financial statements for external reporting purposes in accordance with IFRS both as issued by the IASB and as subsequently adopted by the EU.
Trinity Biotech’s internal control over financial reporting includes policies and procedures that pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect transactions and dispositions of assets; provide reasonable assurances that transactions are recorded as necessary to permit preparation of the financial statements in accordance with IFRS and that receipts and expenditures are being made only in accordance with the authorisation of management and the directors of Trinity Biotech; and provide reasonable assurance regarding prevention or timely detection of unauthorised acquisition, use or disposition of Trinity Biotech’s assets that could have a material effect on our financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect all misstatements.
It is not always possible to conduct an assessment of an acquired business’s internal control over financial reporting in the period between the purchase date and the date of management’s assessment. In such cases, management will note that it has excluded the acquired business or businesses from its report on internal control over financial reporting. Also, projections of any evaluation of the effectiveness of internal control to future periods are subject to the risk that controls may become inadequate because of changes in conditions, and that the degree of compliance with the policies or procedures may deteriorate.
Management has assessed the effectiveness of internal control over financial reporting based on criteria established in the 2013 Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). Based on this assessment, management has concluded that the Group’s internal control over financial reporting was effective as of December 31, 2025.
Since Trinity Biotech is a non-accelerated filer, our auditor, Grant Thornton, an independent registered public accounting firm, is not required to issue an attestation report on the Group’s internal control over financial reporting as of December 31, 2025.
Changes in Internal Control over Financial Reporting
There were no changes to our internal control over financial reporting that occurred during the period covered by this Form 20-F that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 16. Reserved
16A. Audit Committee Financial Expert
Mr. Paul Tivnan is an independent director who joined as a member of the Audit Committee in September 2025. Our board of directors has determined that Mr. Paul Tivnan meets the definition of an audit committee financial expert, as defined in Item 401 of Regulation S-K.
Management notes that due to changes in the composition of the Board of Directors, the Audit Committee now consists of only one director. However, the Board of Directors are seeking to recruit at least one additional suitably qualified independent director to join the Audit Committee in order to strengthen the internal control environment including the Committee’s oversight of its external auditors.
16B. Code of Ethics
Trinity Biotech has adopted a code of ethics that applies to the Chief Executive Officer, Chief Financial Officer and all organisation employees. Written copies of the code of ethics are available free of charge upon written request to us at the address on the first page of this annual report. If we make any substantive amendments to the code of ethics or grant any waivers, including any implicit waiver, from a provision of these codes to our Chief Executive Officer, Chief Financial Officer or Chief Accounting Officer, we will disclose the nature of such amendment or waiver on our website.
16C. Principal Accountant Fees and Services
Fees Billed by Independent Public Accountants
The following table sets forth, for each of the years indicated, the fees billed by our independent public accountants and the percentage of each of the fees out of the total amount billed by the accountants.
Audit
1,511
83%
1,244
90%
Tax
315
17%
141
10%
1,826
1,385
Audit services include audit of our consolidated financial statements including interim financial statements, as well as work only the independent auditors can reasonably be expected to provide, including statutory audits. Audit related services are for assurance and related services performed by the independent auditor, including any special procedures required to meet certain regulatory requirements. Tax fees consist of fees for professional services for tax compliance and tax advice.
Pre-Approval Policies and Procedures
Our Audit Committee has adopted policies and procedures for the pre-approval of audit and non-audit services rendered by our independent public accountants, Grant Thornton. The policy generally pre-approves certain specific services in the categories of audit services, audit-related services, and tax services up to specified amounts, and sets requirements for specific case-by-case pre-approval of discrete projects, those which may have a material effect on our operations or services over certain amounts.
Pre-approval may be given as part of the Audit Committee’s approval of the scope of the engagement of our independent auditor or on an individual basis. The pre-approval of services may be delegated to one or more of the Audit Committee’s members, but the decision must be presented to the full Audit Committee at its next scheduled meeting. The policy prohibits retention of the independent public accountants to perform the prohibited non-audit functions defined in Section 201 of the Sarbanes-Oxley Act or the rules of the SEC, and also considers whether proposed services are compatible with the independence of the public accountants.
16D. Exemptions from the Listing Standards for Audit Committees
16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers
None.
Share Buyback
Trinity Biotech did not purchase any of its own shares during 2025 or 2024.
16F. Change in Registrant’s Certifying Accountant
16G. Corporate Governance
NASDAQ Stock Market Rules and Home Country Practice
Under NASDAQ Stock Market Rule 5615(a)(3), foreign private issuers, such as our company, are permitted to follow certain home country corporate governance practices instead of certain provisions of the NASDAQ Stock Market Rules. A foreign private issuer that elects to follow a home country practice instead of any of such NASDAQ requirements must submit to NASDAQ, in advance, a written statement from an independent counsel in such issuer’s home country certifying that the issuer’s practices are not prohibited by the home country’s laws. We provided NASDAQ with such a letter of non-compliance with respect to:
Rule 5605(b)(1) - The Rule requiring maintaining a majority of independent directors. Instead, under Irish law and practice, we are not required to appoint a majority of independent directors.
Rule 5605(b)(2) -The Rule requiring that our independent directors have regularly scheduled meetings at which only independent directors are present. Instead, we follow Irish law according to which independent directors are not required to hold executive sessions.
Rule 5605(e) - The Rule regarding independent director oversight of director nominations process for directors. Instead, we follow Irish law and practice according to which our board of directors recommends directors for election/re-election by our shareholders.
Rule 5635(c) - The requirement to obtain shareholder approval for the establishment or amendment of certain equity based compensation plans, an issuance that will result in a change of control of the company (Rule 5635(b)), certain transactions other than a public offering involving issuances of a 20% or more interest in the company (Rule 5635(d)) and certain acquisitions of the stock or assets of another company (Rule 5635(a)). Instead, we follow Irish law and practice in approving such procedures, according to which Board approval may suffice in certain circumstances, depending on the extent existing general authorities to issue shares are in place.
Rule 5605(c)(2) - The Rule requiring maintaining an audit committee consisting of at least three independent directors. Instead, we follow Irish law that requires that an audit committee have at least one independent director.
Rule 5605(d)(2) - The Rule requiring a compensation committee consisting of at least two independent directors. We have had a compensation committee, which we referred to as the remuneration committee. We have engaged an international consultancy to advise the Board on Board and executive compensation.
Rule 5620(c) - The Rule requiring a quorum of 33 1/3% at any meeting of shareholders (Rule 5620(c)). Instead, we follow the provisions of our Articles which require a quorum of 40%. If a quorum is not present within 30 minutes (or such longer time not exceeding one hour as the chairperson of the meeting may decide to wait) after the time appointed for the holding of the meeting a quorum is not present, or if during the meeting a quorum ceases to be present, the meeting, if convened on the requisition of shareholders, shall be dissolved and in any other case, shall stand adjourned to the same day in the next week or to such other day and at such other time and place as the chairperson (or, in default, the board of directors) may, subject to the provisions of the Companies Act 2014, determine. If at such adjourned meeting a quorum is not present within 15 minutes after the time appointed for holding it, the members present in person or by proxy shall be a quorum, but so that not less than two individuals shall constitute a quorum.
16H. Mine Safety Disclosure
16I. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections
Item 16J. Insider Trading Policies
We have adopted insider trading policies and procedures governing the purchase, sale, and/or other dispositions of our ordinary shares by directors, officers and employees, that are reasonably designed to promote compliance with insider trading laws, rules and regulations, and the Nasdaq listing standards.
Item 16K. Cybersecurity
Risk management and strategy
We have not experienced any material cybersecurity incidents that have impacted our operations to date. However, like most companies, we are subject to frequent and evolving cybersecurity threats and attempted attacks from a range of sources, including opportunistic hackers, organised threat actors, and internal vulnerabilities.
To identify, assess, and mitigate cybersecurity risks, we have implemented a cybersecurity program covering the full scope of our information systems and data assets. This includes internally managed systems, cloud environments, third party-hosted infrastructure, and sensitive data such as intellectual property, clinical research information, strategic documents, personal data of employees and trial participants, and confidential commercial information, collectively referred to as our “Information Systems and Data.”
Our cybersecurity program is led by our Chief Information Officer (CIO), who has over 20 years of IT leadership experience, and is supported by an internal security function that collaborates with our broader risk management team. The CIO works across the organisation to ensure that cybersecurity is embedded within our operations and treated as a core business risk.
We maintain a cybersecurity risk management programme designed to identify, assess, and manage risks to the confidentiality, integrity, and availability of our information systems and data. Our programme incorporates multiple layers of preventative and detective security controls, aligned with recognised industry frameworks, like the NIST Cybersecurity Framework. These controls support our ability to safeguard operational, financial, and personal data used across our global business.
Our approach to cybersecurity risk management includes:
Threat Monitoring and Protection: We employ next‑generation firewalls, endpoint protection, antivirus tools, email filtering, and security logging to monitor our environment for malicious or unauthorised activity.
Access and Identity Security: Multi‑factor authentication is implemented across the organisation, and access to systems is controlled using least‑privilege principles. Periodic user access recertification is performed, and segregation of duties is independently reviewed where relevant.
Vulnerability and Patch Management: Routine vulnerability scanning and patch deployment practices ensure timely remediation of identified risks. Exceptions to patching windows are documented and reviewed as part of IT governance procedures.
Backups and Business Continuity: We operate centralised and site‑level backup processes, incorporating cloud and offsite storage to protect critical data. Disaster recovery capabilities vary by location, and we continue to invest in improving response and restoration times.
Incident Management: We maintain formal Incident and Problem Management processes, including defined escalation paths to the CIO and senior management for any major or security‑related incidents. Regular reviews and root‑cause analyses support our commitment to continuous improvement.
Security Awareness: Employees receive cybersecurity and data‑protection training, including simulated phishing exercises, policy refreshers, and updates on emerging threats.
We also monitor emerging regulatory developments and industry standards to ensure our practices remain aligned with evolving expectations. Our cybersecurity practices are regularly reviewed and enhanced in response to changing threat dynamics.
Cybersecurity risk management is also extended to our third-party service providers, who perform a wide range of business-critical services including data hosting, software delivery, clinical research, supply chain management, distribution, and contract manufacturing. We assess the cybersecurity posture of key vendors through a combination of tools, such as security questionnaires, audits, analysis of certifications (e.g., ISO 27001, SOC 2), reviews of written security policies, and assessment of penetration test results. Where necessary, we engage in direct discussions with vendors' security teams to evaluate controls. We also impose contractual obligations related to cybersecurity and data protection, including confidentiality and breach notification requirements. These measures are designed to reduce the risk of vulnerabilities introduced through our supply chain or external partners.
Cybersecurity risks are addressed through our overall approach to operational and strategic risk management. Key risks are discussed at senior management level and prioritised based on their potential to affect our systems, data, or business continuity.
Governance
Oversight of cybersecurity risk forms part of the Board of Directors’ general risk oversight responsibilities. Our Chief Information Officer (CIO) is responsible for the day-to-day implementation and ongoing development of our cybersecurity program.
The CIO is involved in reviewing security assessments, monitoring threat activity, approving key cybersecurity controls, and helping coordinate incident preparedness across the organisation. In the event of a cybersecurity incident, our escalation procedures provide for involvement of senior management, including the CIO and, where appropriate, other members of the executive team and relevant support functions.
Cybersecurity matters are reported to senior management as needed, particularly in cases where a threat or incident may have a broader business impact. Our governance structure is designed to support informed decision-making around risk prioritisation, incident response, and investment in cybersecurity measures. As of the date of this filing, we are not aware of any cybersecurity threats, including past incidents, that have materially affected or are reasonably likely to materially affect our business strategy, results of operations, or financial condition.
Part III
The registrant has responded to Item 18 in lieu of responding to this item.
The audited consolidated financial statements as required under Item 18 are attached hereto starting on page 107 of this Annual Report. The audit report of Grant Thornton (PCAOB ID 1402), independent registered public accounting firm, is included herein preceding the audited consolidated financial statements.
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors and Shareholders
Opinion on the financial statements
We have audited the accompanying consolidated statements of financial position of Trinity Biotech plc and subsidiaries (the “Company”) as of December 31, 2025 and 2024, the related consolidated statements of operations, comprehensive income, changes in equity, and cash flows for each of the three years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the 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 three years in the period ended December 31, 2025, in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.
Going concern
As discussed in Note 1(iii) to the financial statements, the Company has suffered recurring losses from operations and has a net capital deficiency. Management’s evaluation of the events and conditions and managements’ plans to mitigate these matters are also described in Note 1(iii).
Basis for opinion
These consolidated 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 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 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 financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the 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 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 financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical audit matters
The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of a critical audit matter does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Impairment assessment of goodwill and long‑lived assets
Refer to Note 12 to the financial statements. As at December 31, 2025 prior to impairment analysis, the intangible assets of the Company totalled $59.1 million, property, plant and equipment of the Company totalled $5.5 million and prepayments of the Company totalled $1.7 million. The Company recognised $2.2 million impairment during the year ended December 31, 2025. In addition, the Company recognised intangible assets and goodwill of $9.0 million and property plant and equipment of $2.2 million in 2025.
The Company’s evaluation of the carrying value of long-lived assets for impairment involves the comparison of the recoverable amount of each cash generating unit (CGU) to its carrying value. In addition, the Company assessed certain individual assets by comparing their recoverable amounts to their respective carrying values. The Company used the value-in-use approach, which deploys a discounted cash flow model to estimate the recoverable amount.
This requires management to make significant estimates and assumptions related to discount rates, short-term forecasts of future revenues and margins, and long-term growth rates which drive net cash flows. Changes in these assumptions could have a significant impact on the recoverable amount, the amount of any impairment charge, or both.
The principal consideration for our determination that impairment of goodwill and long‑lived assets is a critical audit matter was the significant judgement required by management in estimating the recoverable amounts of certain CGUs and individual assets and comparing those amounts to their carrying values. We focused on CGUs which have significant non-current assets in the current year (collectively the “selected CGUs”) and certain individual assets which exhibited indicators of impairment.
This required a high degree of auditor judgement and an increased extent of effort, when performing audit procedures to evaluate the reasonableness of management’s estimates and assumptions as described above.
104
Our audit procedures related to the impairment assessment of goodwill and long-lived assets, included the following, among others:
We identified the selected CGUs with significant non‑current assets and individual assets exhibiting impairment indicators, and evaluated the design effectiveness of controls over management’s selection of key assumptions used to determine their recoverable amounts.
We agreed the underlying cash flow forecasts against budgets of the selected CGUs and individual assets and we evaluated management’s ability to accurately forecast future revenue, margins and expenses by:
performing a look-back analysis and comparing actual results to management’s historical forecasts; and
assessing the reasonableness of cashflows of new and in-progress products.
We assessed the reasonableness of the valuation model used by the Company compared to generally accepted valuation practices and accounting standards.
We tested the mathematical accuracy of the discounted cash flow models, including the calculation of present values, terminal values, and internal consistency of assumptions applied across periods.
We tested the source information underlying the determination of the discount rates through use of observable inputs from independent external sources and we developed independent estimates and compared those to the discount rates selected by management.
We compared the long-term growth rates, used by management to grow cash flows in order to calculate a terminal value, to independent external sources to assess the reasonableness of these rates
We performed sensitivity analyses around significant management assumptions, such as discount rate and growth rate, to account for uncertainties around assumptions in the valuation model.
Going concern assessment
Refer to Note 1(iii) to the financial statements. Management concluded that it is appropriate to prepare the consolidated financial statements on a going concern basis. In making this assessment, the directors have considered the significant progress made on their multi-year transformation plan which was largely completed by the end of 2025 and is expected to deliver significant annualised cost savings.
The directors also considered the continuing support obtained from the Company’s principal lender and largest investor. During the year, the Company amended its lending agreement to defer the maturity date of its senior secured term loan of $108.0 million from July 2026 to January 2027. The amended agreement also allows the lender to convert up to $72.5 million of the existing term loan into equity. The lender also provided a waiver in relation to the 31 December 2025 revenue covenant. The amendments provide additional flexibility to preserve liquidity while executing the Company’s updated strategy.
In addition, the Company expects to rely on equity funding, primarily through the issuance of ordinary shares under existing capital raising arrangements, to support ongoing operations and continued investment in the Group’s CGM development programme.
Lastly, the directors are undertaking an ongoing strategic realignment review of the Company’s businesses which can result in a potential sale of businesses and can generate material capital proceeds to reduce maturing obligations and support current projects.
Notwithstanding these plans, the Company has incurred recurring losses from operations, experienced net cash outflows from operating activities, and has a significant accumulated deficit.
The principal consideration for our determination that the going concern assessment as a critical audit matter due to the significant judgment required in evaluating the achievability of management’s forecasts, the successful execution of strategic realignment, the Company’s ability to obtain continued financial support from its principal lender and the ability to raise equity funding. These considerations require significant auditor judgment in assessing the uncertainties surrounding management’s assumptions on the Company’s ability to continue as a going concern.
Our audit procedures related to the going concern assessment included the following, among others:
We obtained an understanding, evaluated the design effectiveness of controls over management’s going concern assessment process.
We examined management’s assessment on going concern and performed an independent assessment of the inputs and assumptions used by management in preparing their cash flow forecast by comparing the assumptions and estimates used elsewhere in the preparation of the financial statements.
We reviewed management communication and revised agreements with the lender to extend the maturity of the senior secured term loan to January 2027. We also discussed with management the options being considered in relation to repayment plan of the senior secured term loan.
105
We reviewed the credit agreement and management’s assessment of compliance with debt covenants, including inspection of the revenue covenant waivers obtained for the periods December 31, 2025, March 31, 2026 and June 30, 2026, and the liquidity covenant waiver obtained for the period March 31, 2026 and April 30, 2026.
We considered subsequent events up to the date of the auditor’s report that may affect the going concern conclusion.
We evaluated the adequacy of the Company’s disclosures in the financial statements, including the description of substantial doubt and management plans as required by relevant accounting standards.
Revenue recognised under bill-and-hold arrangements
Refer to Note 31 to the financial statements. The Company recognised revenue under bill-and-hold arrangements amounting to $2.2 million for the year ended 31 December 2025, which were accounted for under the criteria set by IFRS 15 “Revenue from Contracts with Customers”.
The determination of whether the criteria for recognising revenue before delivery of the goods had been met require significant judgement.
The principal considerations for our determination that revenue recognised under bill‑and‑hold arrangements is a critical audit matter were the significant judgments involved in evaluating whether the criteria for bill‑and‑hold revenue recognition had been met. These included assessing whether the customer’s request was substantive, whether the product was complete and ready for transfer, whether the goods were segregated and not available for alternative use, and whether control had effectively transferred to the customer. The complexity and judgment involved in evaluating these conditions increased the risk of premature or inappropriate revenue recognition, which required significant auditor attention.
Our audit procedures related to revenue recognised under bill-and-hold arrangements included the following, among others:
We evaluated the design effectiveness of certain internal controls related to the Company's revenue recognition and cut-off process, including controls over assessment of whether the bill-and-hold criteria are met.
We inspected customer requests, contracts, letter of ownership, supporting documentation and correspondence to assess whether the arrangements met the criteria for bill‑and‑hold revenue recognition under the applicable accounting framework.
We sent confirmation letters to those customers under bill-and-hold arrangements to confirm the arrangement.
We observed or inspected evidence that the arrangement is substantive and the goods were segregated, and not available for alternative use, including physical verification where appropriate.
We tested the timing and accuracy of revenue recognised for bill‑and‑hold transactions and evaluated whether disclosures in the financial statements were complete and appropriate.
/s/ GRANT THORNTON
Dublin, Ireland
We have served as the Company’s auditor since 2008.
April 30, 2026
106
CONSOLIDATED STATEMENT OF OPERATIONS
Year ended December 31
Notes
Revenues
Cost of sales
(26,898)
(40,114)
(37,382)
Gross profit
16,887
21,441
19,450
Other operating income/(expense)
1,870
(1,787)
(3,629)
(4,543)
(4,379)
(24,674)
(28,815)
(31,152)
Selling, general and administrative expenses – Transformation costs
(4,252)
(4,181)
Once off items
186
(1,872)
(2,177)
(1,408)
(11,105)
Operating loss
(15,789)
(21,165)
(27,045)
1,171
(21,388)
(9,565)
(11,053)
Net financing expense
(9,882)
Loss before tax
7, 9
(37,177)
(30,730)
(36,927)
Total income tax (expense)/credit
2, 7
(199)
(486)
Loss for the year on continuing operations
2, 10
(37,376)
(31,216)
(36,868)
(Loss)/profit for the year on discontinued operations
(573)
12,850
Loss for the year (all attributable to owners of the parent)
(31,789)
(24,018)
Basic loss per ADS (US Dollars) – continuing operations
(2.0)
(1.7)
(4.8)
Diluted loss per ADS (US Dollars) – continuing operations
Basic loss per ‘A’ ordinary share (US Dollars) – continuing operations
(0.1)
Diluted loss per ‘A’ ordinary share (US Dollars) – continuing operations
Basic loss per ADS (US Dollars) – group
(1.8)
(3.1)
Diluted loss per ADS (US Dollars) – group
Basic loss per ‘A’ ordinary share (US Dollars) – group
Diluted loss per ‘A’ ordinary share (US Dollars) – group
107
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
Loss for the year
Other comprehensive (loss)/profit
Items that will be reclassified subsequently to profit or loss
Foreign exchange translation differences
(316)
245
Total Comprehensive Loss (all attributable to owners of the parent)
(37,692)
(31,544)
(23,949)
108
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
At December 31
ASSETS
Non-current assets
Property, plant and equipment
5,302
4,621
Goodwill and intangible assets
56,987
51,343
Financial assets
2,773
2,455
Deferred tax assets
3,924
3,553
Derivative financial instruments
249
Other assets
Total non-current assets
69,263
62,166
Current assets
Inventories
18,828
19,374
Trade and other receivables
11,480
16,065
Income tax receivable
456
518
5,138
5,167
Total current assets
35,902
41,124
TOTAL ASSETS
105,165
103,290
EQUITY AND LIABILITIES
Equity attributable to the equity holders of the parent
Share capital
4,190
Share premium
63,800
63,397
Treasury shares
(24,922)
Accumulated deficit
(116,169)
(79,117)
Translation reserve
(5,777)
(5,461)
Equity component of convertible note
19, 23
6,709
Other reserves
4,337
Total deficit
(71,982)
(35,181)
Current liabilities
Senior secured term loan
108,015
Income tax payable
348
364
Trade and other payables
29,703
26,782
Provisions
345
2,454
Exchangeable notes and other borrowings
210
Lease liabilities
2,588
2,285
Total current liabilities
141,209
32,095
Non-current liabilities
72,391
Derivative financial liability
3,320
1,658
Convertible note
16,330
15,401
Contingent consideration
1,813
781
10,840
10,477
Deferred tax liabilities
4,667
4,561
Total non-current liabilities
35,938
106,376
TOTAL LIABILITIES
177,147
138,471
TOTAL EQUITY AND LIABILITIES
109
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
‘A’ ordinary
shares
Share
premium
Treasury
Translation
reserve
Equity Component
of
convertible Note
Other
reserves
Accumulated
(deficit)/surplus
Balance at January 1, 2023
1,963
46,458
(5,775)
(26,695)
(2,176)
Loss for the period
Other comprehensive income
Total comprehensive loss
Shares issued in the year (Note 19)
161
(63)
Share-based payments (Note 20)
2,069
Balance at December 31, 2023
1,972
46,619
(5,706)
(48,644)
Balance at January 1, 2024
2,218
16,778
18,996
1,316
Balance at December 31, 2024
Balance at January 1, 2025
164
449
613
Reclass on reduction of nominal value of shares (Note 19)
(4,314)
4,314
324
Share issue expenses
(46)
Balance at December 31, 2025
110
CONSOLIDATED STATEMENT OF CASH FLOWS
Year Ended December 31,
Cash flows from operating activities
Adjustments to reconcile net loss to cash provided by operating activities:
Depreciation
9, 11
1,299
675
831
Amortisation
9,12
1,190
946
Income tax expense/(credit)
199
486
(59)
(1,171)
Financial expense
21,388
9,565
11,053
Share-based payments (net of capitalized amounts)
Foreign exchange gains/(losses) on operating cash flows
(1,102)
1,010
238
Movement in inventory provision
629
2,113
2,291
Inventory write off
1,884
Impairment of property, plant and equipment
5, 11
612
3,772
Impairment of intangible assets
5, 12
2,144
1,596
5,833
(186)
Liabilities related to financial assets (reversal)/written off
5, 13
(800)
1,500
Gain on sale of business
(12,718)
Transformation provision
187
361
Other non-cash items
(908)
2,505
257
Operating cash flows before changes in working capital
(11,984)
(9,276)
(9,176)
Decrease/ (increase) in trade and other receivables
4,920
(2,368)
1,047
Decrease/ (increase) in inventories
(1,742)
(971)
Increase/ (decrease) in trade and other payables
1,391
8,185
(2,769)
Cash used in operations
(5,583)
(5,201)
(11,869)
Interest received
Income taxes (paid)/ received
(346)
312
(11,557)
Cash flows from investing activities
Payments to acquire intangible assets
(6,135)
(9,659)
(1,901)
Acquisition of property, plant and equipment
(88)
(405)
(803)
Payments to acquire financial asset
(700)
Proceeds from sale of business (net of transaction costs)
28,160
Payments to acquire trades or businesses
(12,904)
Net cash (used in)/generated by investing activities
24,756
Cash flows from financing activities
Issue of ordinary share capital including share premium (net of issuance costs)
547
7,391
Proceeds from shares to be issued
Net proceeds from senior secured term loan
15,000
30,176
5,000
Expenses paid in connection with debt financing
(147)
Repayment of senior secured term loan
(10,050)
Penalty for early settlement of term loan
(905)
Interest paid on senior secured term loan
(5,946)
(7,314)
Interest paid on convertible note
(300)
Interest paid on exchangeable notes
(8)
Payment of lease liabilities
(3,187)
(2,503)
(2,318)
Net cash generated by/(used in) financing activities
(16,042)
(Decrease)/ increase in cash and cash equivalents and short-term investments
(2,843)
Effects of exchange rate movements on cash held
(175)
(44)
Cash and cash equivalents and short-term investments at beginning of year
3,691
6,578
Cash and cash equivalents and short-term investments at end of year
111
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2025
1.
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES
The principal accounting policies adopted by Trinity Biotech plc (“the Company”) and its subsidiaries (together the “the Group”) are set out below.
i)
General information
Trinity Biotech is a commercial stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors. The Company develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market. The products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood and the Company intends to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring product.
ii)
Statement of compliance
The consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) both as issued by the International Accounting Standards Board (“IASB”) and as subsequently adopted by the European Union (“EU”) (together “IFRS”). The IFRS applied are those effective for accounting periods beginning January 1, 2025. Consolidated financial statements are required by Irish law to comply with IFRS as adopted by the EU which differ in certain respects from IFRS as issued by the IASB. These differences predominantly relate to the timing of adoption of new standards by the EU. However, in relation to the 2025 consolidated financial statements there are no differences regarding the effective date of new IFRS relevant to Trinity Biotech as issued by the IASB and as adopted by the EU. In relation to prior periods presented, none of the differences are relevant in the context of Trinity Biotech and the consolidated financial statements comply with IFRS both as issued by the IASB and as adopted by the EU.
iii)
Basis of preparation and going concern
The consolidated financial statements have been prepared in United States Dollars (US$), rounded to the nearest thousand, under the historical cost basis of accounting, except for derivative financial instruments, certain balances arising on acquisition of subsidiary entities and share-based payments which are initially recorded at fair value. Derivative financial instruments are also subsequently revalued and carried at fair value.
The preparation of financial statements in conformity with IFRS requires management to make judgements, estimates and assumptions that affect the application of policies and amounts reported in the financial statements and accompanying notes. The estimates and associated assumptions are based on historical experience and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis of making the judgements about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates.
The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognised in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and future periods if the revision affects both current and future periods. Judgements made by management that have a significant effect on the financial statements and estimates with a significant risk of material adjustment in the next year are discussed in Note 31.
As reflected in the accompanying consolidated financial statements, for the years ended December 31, 2025 and 2024, the Group recorded a loss of US$37.4 million and a loss of US$31.8 million, respectively. For the year ended December 31, 2025 we reported cash outflows of US0.1 million compared to cash inflows of US$1.7 million for 2024. As of December 31, 2025, we had net current liabilities of US$105.3 million and also an accumulated deficit in equity attributable to the equity holders of the Company of US$72.0 million.
We have made significant progress on a multi‑year transformation plan aimed at improving profitability and simplifying our operating model. During 2024 and 2025, the Group substantially executed this programme, including the consolidation and outsourcing of global manufacturing operations, the closure of underutilised facilities, the transition of production to third‑party manufacturing partners, the relocation of selected business support functions to lower‑cost jurisdictions, and a reduction in overall headcount. These actions have materially reduced the Group’s fixed cost base and simplified its operational footprint, and the majority of the related restructuring activities were completed during 2025. As a result, the Group has entered 2026 with a leaner operating model and a materially lower underlying cost structure. In addition, the Group retains further levers to manage liquidity if required, including the ability to defer, phase or reprioritise discretionary research and development expenditure.
112
BASIS OF PREPARATION AND SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
Basis of preparation (continued)
The Group continues to benefit from strong support from Perceptive, its principal lender. Under the current credit agreement, the contractual maturity of the Term Loan is January 15, 2027, and there are no scheduled principal repayments prior to this date. In April 2026, the Group entered into a third amendment to the Credit Agreement with Perceptive which provided for an additional US$2.5 million term loan borrowing and limited waivers in respect of certain financial covenants. In February 2026, Perceptive agreed that 50% of the cash interest due would be paid as PIK interest, and in March 2026 and April 2026, Perceptive agreed that 100% of the cash interest due would be paid as PIK interest. These arrangements have been reflected in management’s cash flow forecasts.
The Group breached the minimum revenue covenant under the facility for the quarter ended December 31, 2025. The covenant breach primarily reflected timing‑related variability in HIV revenues, including the timing of the scale‑up of the Group’s outsourced and offshored manufacturing model. These factors affected the timing of shipments and revenue recognition between reporting periods, rather than indicating a deterioration in underlying demand. As part of the third amendment, Perceptive provided a waiver in respect of this breach. In addition, the Group received specific waivers and deferrals in respect of compliance with certain financial covenants applicable to covenant measurement periods occurring after year‑end. In forming its going concern assessment, management has considered the contractual terms of the facility as amended, including the agreed waivers and deferrals. Management’s cash flow forecasts, which incorporate the terms of the Credit Agreement as amended, demonstrate that the Group is able to meet its obligations under the Perceptive facility throughout the going concern review period, including compliance with the amended financial covenants. The forecasts also assume a reduction in debt service obligations through the partial equitisation of the Perceptive Term Loan during the forecast period. Under the Credit Agreement, the Group is required to maintain a minimum unrestricted cash balance of US$3.0 million from July 1, 2026. Based on the forecasts, management remains confident in the Group’s ability to meet its obligations under the Perceptive facility throughout the going concern review period.
The accounting policies set out below have been applied consistently to all periods presented in these consolidated financial statements. The accounting policies have been applied consistently by all Group entities. The comparative information agrees with the amounts and other disclosures presented in the prior period consolidated financial statements or, when appropriate, have been restated.
iv)
Basis of consolidation
Subsidiaries
Subsidiaries are all entities over which the Group has control. The Group controls an entity when the Group is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power over the entity. Subsidiaries are fully consolidated from the date on which control is transferred to the Group. They are deconsolidated from the date that control ceases. A change in the ownership interest of a subsidiary without a change in control is accounted for as an equity transaction. The Group currently holds a majority of voting rights in all entities in the Group and as a result there are no non-controlling interests reflected in the consolidated financial statements.
Transactions eliminated on consolidation
Intra-group balances and any unrealised gains or losses or income and expenses arising from intra-group transactions are eliminated in preparing the consolidated financial statements.
v)
Owned assets
Items of property, plant and equipment are stated at cost less any accumulated depreciation and any impairment losses (see Note 1(viii)). The cost of self-constructed assets includes the cost of materials, direct labour and attributable overheads. It is not Group policy to revalue any items of property, plant and equipment.
Depreciation is charged to the statement of operations on a straight-line basis to write-off the cost of the assets over their expected useful lives as follows:
• Leasehold improvements
5-15 years
• Buildings
50 years
• Office equipment and fittings
10 years
• Computer equipment
3-5 years
• Plant and equipment
Land is not depreciated. The residual values, if not insignificant, useful lives and depreciation methods of property, plant and equipment are reviewed and adjusted if appropriate on a prospective basis, at each balance sheet date. There were no changes to useful lives in the year.
Leased assets
The Group considers whether a contract is or contains a lease. A lease is defined as ‘a contract, or part of a contract, that conveys the right to use an asset (the underlying asset) for a period of time in exchange for consideration’. To apply this definition the Group assesses whether the contract meets three key evaluations which are whether:
the contract contains an identified asset, which is either explicitly identified in the contract or implicitly specified by being identified at the time the asset is made available to the Group
the Group has the right to obtain substantially all of the economic benefits from use of the identified asset throughout the period of use, considering its rights within the defined scope of the contract
the Group has the right to direct the use of the identified asset throughout the period of use. The Group assess whether it has the right to direct ‘how and for what purpose’ the asset is used throughout the period of use.
114
Property, plant and equipment (continued)
At lease commencement date, the Group recognises a right-of-use asset and a lease liability on the balance sheet. The right-of-use asset is measured at cost, which is made up of the initial measurement of the lease liability, any initial direct costs incurred by the Group, an estimate of any costs to dismantle and remove the asset at the end of the lease, and any lease payments made in advance of the lease commencement date (net of any incentives received).
The Group depreciates the right-of-use assets on a straight-line basis from the lease commencement date to the earlier of the end of the useful life of the right-of-use asset or the end of the lease term. The Group also assesses the right-of-use asset for impairment when such indicators exist.
At the commencement date, the Group measures the lease liability at the present value of the lease payments unpaid at that date, discounted using the interest rate implicit in the lease if that rate is readily available or the Group’s incremental borrowing rate. Lease payments included in the measurement of the lease liability are made up of fixed payments (including in substance fixed), variable payments based on an index or rate, amounts expected to be payable under a residual value guarantee and payments arising from options reasonably certain to be exercised. Subsequent to initial measurement, the liability will be reduced for payments made and increased for interest. It is remeasured to reflect any reassessment or modification, or if there are changes in in-substance fixed payments. When the lease liability is remeasured, the corresponding adjustment is reflected in the right-of-use asset, or profit and loss if the right-of-use asset is already reduced to zero.
The Group has elected to account for short-term leases and leases of low-value assets using the practical expedients. Instead of recognising a right-of-use asset and lease liability, the payments in relation to these are recognised as an expense in profit or loss on a straight-line basis over the lease term. On the statement of financial position, right-of-use assets have been included in property, plant and equipment and lease liabilities have been included in separate lines within the current liabilities and non-current liabilities sections.
Leased assets - as lessor
As a lessor, the Group classifies its leases as either operating or finance leases. A lease is classified as a finance lease if it transfers substantially all the risks and rewards incidental to ownership of the underlying asset, and classified as an operating lease if it does not.
vi)
Business combinations & goodwill
At the time of each transaction, the Group evaluates whether the acquisition constitutes a business combination in accordance with the definition in IFRS 3 Business Combinations. A business is defined as an integrated set of activities and assets that is capable of being conducted and managed for the purpose of providing a return. The assessment considers whether the acquired set includes inputs and substantive processes that together significantly contribute to the ability to create outputs. Where such criteria are not met, the transaction is accounted for as an asset acquisition. Transactions assessed as asset acquisitions do not give rise to goodwill.
In respect of business combinations that have occurred since January 1, 2004 (being the transition date to IFRS), goodwill represents the difference between the cost of the acquisition and the fair value of the net identifiable assets acquired. In respect of acquisitions prior to this date, goodwill is included on the basis of its deemed cost, which represents the amount recorded under Irish GAAP.
To the extent that the Group’s interest in the net fair value of the identifiable assets, liabilities and contingent liabilities acquired exceeds the cost of a business combination, the identification and measurement of the related assets, liabilities and contingent liabilities are revisited accompanied by a reassessment of the cost of the transaction, and any remaining balance is immediately recognised in the statement of operations.
At the acquisition date, any goodwill is allocated to each of the Group’s cash-generating units expected to benefit from the combination’s synergies. Following initial recognition, goodwill is stated at cost less any accumulated impairment losses and is not amortised but is tested annually for impairment.
There were no acquisitions in the year ended December 31, 2025. Refer to Note 29 for details of acquisitions made during the year ended December 31, 2024.
115
vii)
Intangibles, including research and development (other than goodwill)
An intangible asset, which is an identifiable non-monetary asset without physical substance, is recognised to the extent that it is probable that the expected future economic benefits attributable to the asset will flow to the Group and that its cost can be measured reliably. The asset is deemed to be identifiable when it is separable (that is, capable of being divided from the entity and sold, transferred, licenced, rented or exchanged, either individually or together with a related contract, asset or liability) or when it arises from contractual or other legal rights, regardless of whether those rights are transferable or separable from the Group or from other rights and obligations.
Intangible assets acquired as part of a business combination are capitalised separately from goodwill if the intangible asset meets the definition of an asset and the fair value can be reliably measured on initial recognition. In the case of recent acquisitions, the Group has recognised technology-based intangible assets, comprising know-how, trade secrets and similar intellectual property. These assets are classified as finite-lived and are initially recognised at fair value as determined by independent valuation.
Subsequent to initial recognition, these intangible assets are carried at cost less any accumulated amortisation and any accumulated impairment losses (Note 1(viii)). Intangible assets with definite useful lives are reviewed for indicators of impairment annually while intangible assets with indefinite useful lives and those not yet brought into use are tested for impairment at least annually, either individually or at the cash-generating unit level.
Expenditure on development activities, whereby research findings are applied to a plan or design for the production of new or substantially improved products and processes, is capitalised if the product or process is technically and commercially feasible and the Group has sufficient resources to complete the development. The expenditure capitalised includes the cost of materials, direct labour and attributable overheads and third party costs. Subsequent expenditure on capitalised intangible assets is capitalised only when it increases the future economic benefits embodied in the specific asset to which it relates.
The technical feasibility of a new product is determined by a specific feasibility study undertaken at the first stage of any development project. The majority of our new product developments involve the transfer of existing product know-how to a new application. Since the technology is already proven in an existing product which is being used by customers, this facilitates the proving of the technical feasibility of that same technology in a new product.
The results of the feasibility study are reviewed by a design review committee comprising senior managers. The feasibility study occurs in the initial research phase of a project and costs in this phase are not capitalised.
The commercial feasibility of a new product is determined by preparing a discounted cash flow projection. This projection compares the discounted sales revenues for future periods with the relevant costs. As part of preparing the cash flow projection, the size of the relevant market is determined, feedback is sought from customers and the strength of the proposed new product is assessed against competitors’ offerings. Once the technical and commercial feasibility has been established and the project has been approved for commencement, the project moves into the development phase.
All other development expenditure is expensed as incurred. Subsequent to initial recognition, the capitalised development expenditure is carried at cost less any accumulated amortisation and any accumulated impairment losses.
Expenditure on research activities, undertaken with the prospect of gaining new scientific or technical knowledge and understanding, is recognised in the statement of operations as an expense as incurred.
Expenditure on internally generated goodwill and brands is recognised in the statement of operations as an expense as incurred.
Borrowing costs that are directly attributable to the development of qualifying intangible assets are capitalised in accordance with IAS 23 and IAS 38. Where development expenditure is funded through general borrowings, borrowing costs are capitalised using a weighted average capitalisation rate based on borrowings outstanding during the period. Capitalisation commences when expenditure and borrowing costs are incurred and development activities are in progress, and ceases when the asset is substantially ready for its intended use. All other borrowing costs are expensed as incurred.
116
Intangibles, including research and development (other than goodwill) (continued)
Amortisation is charged to the statement of operations on a straight-line basis over the estimated useful lives of intangible assets, unless such lives are indefinite. Intangible assets are amortised from the date they are available for use in its intended market. The estimated useful lives are as follows:
• Capitalised development costs
15 years
• Patents and licences
6-15 years
• Other (including acquired customer and supplier lists)
The Group uses a useful economic life of 15 years for capitalised development costs. This represents management’s best estimate of the useful economic life of the related products, based on expected product life cycles and relevant industry characteristics. The following factors have been considered in estimating the useful life of developed products:
(a) once a diagnostic test becomes established, customers are reluctant to change to new technology until it is fully proven, thus resulting in relatively long product life cycles. There is also reluctance in customers to change to a new product as it can be costly both in terms of the initial changeover cost and as new technology is typically more expensive.
(b) demand for the diagnostic tests is enduring and robust within a wide geographic base. The diseases that the products diagnose are widely prevalent (HIV, Diabetes and Chlamydia being just three examples) in many countries. There is a general consensus that these diseases will continue to be widely prevalent in the future. Demand for biosensors is showing high growth in recent years due to the ease of use and the appeal of real time information.
(c) there are significant barriers to new entrants in this industry. Patents and/or licences are in place for several of our products, though this is not the only barrier to entry. There is a significant cost and time to develop new products, it is necessary to obtain regulatory approval and tests are protected by proprietary know-how, manufacturing techniques and trade secrets.
During the year ended December 31, 2025, the Group capitalised US$6.1 million in development costs and US$2.9 million in borrowing costs related to intangible assets acquired in 2024. As the underlying intellectual property remains at a pre-commercialisation stage and is not yet available for use, amortisation has not commenced. Amortisation will begin when the assets are brought into use, in accordance with the Group’s stated policy.
Technology-based intangible assets acquired as part of business combinations are assigned finite useful lives in line with the Group’s amortisation policies, based on independent valuation reports. Amortisation of these assets will commence when they are available for use, i.e., when they are in the location and condition necessary for them to be capable of operating in the manner intended by management. For technology-based intangible assets acquired in 2024, amortisation has not commenced as the technologies have not yet been commercialised.
Certain trade names acquired are deemed to have an indefinite useful life as there is no foreseeable limit to the period over which these assets are expected to generate cash inflows for the Group.
Where amortisation is charged on assets with finite lives, this expense is taken to the statement of operations through the ‘selling, general and administrative expenses’ line.
Useful lives are examined on an annual basis and adjustments, where applicable, are made on a prospective basis.
117
viii)
Impairment
The carrying amount of the Group’s assets, other than inventories, accounts receivable, cash and cash equivalents, short-term investments and deferred tax assets, are reviewed at each balance sheet date to determine whether there is any indication of impairment. If any such indication exists, the asset’s recoverable amount (being the greater of fair value less costs to sell and value in use) is assessed at each balance sheet date.
Fair value less costs to sell is defined as the amount obtainable from the sale of an asset or cash-generating unit in an arm’s length transaction between knowledgeable and willing parties, less the costs that would be incurred on disposal. Value in use is defined as the present value of the future cash flows expected to be derived through the continued use of an asset or cash-generating unit. In assessing value in use, the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset for which the future cash flow estimates have not yet been adjusted. The estimates of future cash flows exclude cash inflows or outflows attributable to financing activities. For an asset that does not generate largely independent cash flows, the recoverable amount is determined by reference to the cash-generating unit to which the asset belongs.
For goodwill, assets that have an indefinite useful life and intangible assets that are not yet available for use, the recoverable amount is estimated at each balance sheet date at the cash-generating unit level. The goodwill and indefinite-lived assets were reviewed for impairment at June 30, 2024, December 31, 2024, June 30, 2025 and December 31, 2025. See Note 12.
In-process research and development (IPR&D) is tested for impairment on a bi-annual basis, and always at year end, or more frequently if impairment indicators are present, using projected discounted cash flow models. If IPR&D becomes impaired or is abandoned, the carrying value of the IPR&D is written down to its revised fair value with the related impairment charge recognised in the period in which the impairment occurs. If the fair value of the asset becomes impaired as the result of unfavorable data from any ongoing or future clinical trial, changes in assumptions that negatively impact projected cash flows, or because of any other information regarding the prospects of successfully developing or commercializing our programs, we could incur significant charges in the period in which the impairment occurs. The valuation techniques utilized in performing impairment tests incorporate significant assumptions and judgments to estimate the fair value, as described above. The use of different valuation techniques or different assumptions could result in materially different fair value estimates.
An impairment loss is recognised whenever the carrying amount of an asset or its cash-generating unit exceeds its recoverable amount. Impairment losses are recognised in the statement of operations.
Impairment losses recognised in respect of cash-generating units are allocated first to reduce the carrying amount of any goodwill allocated to cash-generating units and then to reduce the carrying amount of other assets in the cash-generating units on a pro-rata basis.
An impairment loss is reversed only to the extent that the asset’s carrying amount does not exceed the carrying amount that would have been determined, net of depreciation or amortisation, if no impairment loss had been recognised.
An impairment loss in respect of goodwill is not reversed.
Following recognition of any impairment loss (and on recognition of an impairment loss reversal), the depreciation or amortisation charge applicable to the asset or cash-generating unit is adjusted prospectively with the objective of systematically allocating the revised carrying amount, net of any residual value, over the remaining useful life.
ix)
Financial Assets
On initial recognition, a financial asset is classified as measured at amortised cost and subsequently measured using the effective interest rate (EIR) method and subject to impairment. Financial assets may also be initially measured at fair value with any movement being reflected through other comprehensive income or the Consolidated Statement of Operations.
On initial recognition of an equity investment that is not held for trading, the Group may irrevocably elect to present subsequent changes in the investment’s fair value in other comprehensive income. This election is made on an investment-by investment basis.
Where such an election is not made, and the investment is not held for trading, the equity instrument is classified as measured at fair value through profit or loss (FVTPL). Subsequent changes in fair value are recognised in the Consolidated Statement of Operations. During 2024, the Group acquired a strategic equity interest in an unlisted entity accounted for under this classification. Refer to Note 13.
Financial assets are written off when there is no reasonable expectation of recovery, such as when the debtor has entered bankruptcy, when collection efforts have been exhausted, or when the asset has been significantly past due (typically over 365 days) without any recent payments or active correspondence. The Group considers both quantitative factors (such as aging) and qualitative indicators (e.g., legal or insolvency proceedings) in making this assessment. Where receivables are written off but remain subject to enforcement activity, such as legal action or engagement with collection agencies, these efforts are continued until formally closed.
118
x)
Inventories are stated at the lower of cost and net realisable value. Cost is based on the first-in, first-out principle and includes all expenditure which has been incurred in bringing the products to their present location and condition and includes an appropriate allocation of manufacturing overhead based on the normal level of operating capacity. Net realisable value is the estimated selling price of inventory on hand in the ordinary course of business less all further costs to completion and costs expected to be incurred in selling these products.
The Group provides for inventory, based on estimates of the expected realisability. The estimated realisability is evaluated on a case-by-case basis and any inventory that is approaching its “use-by” date and for which no further re-processing can be performed is written off. Any reversal of an inventory provision is recognised in the statement of operations in the year in which the reversal occurs.
xi)
Trade receivables are amounts due from customers for products sold or services provided in the ordinary course of business. Trade and other receivables are stated at their amortised cost less impairment losses incurred. Cost approximates fair value given the short-term nature of these assets. The Group records the loss allowance as lifetime expected credit losses.
These are the expected shortfalls in contractual cash flows, considering the potential for default at any point during the life of the financial instrument. Expected credit losses are recorded on all of trade receivables based on an assessment of the probability of default or delinquency in payments and the probability that debtor will enter into financial difficulties or bankruptcy.
xii)
Trade payables are obligations to pay for goods or services that have been acquired in the ordinary course of business. Trade and other payables are stated at cost. Cost approximates fair value given the short term nature of these liabilities.
xiii)
Cash and cash equivalents comprise cash balances and short-term deposits which are readily available at year-end. Deposits with maturities less than six months as at the year-end date are recognised as cash and cash equivalents and are carried at fair value when there is no expected loss in value on early termination. The Group has no short-term bank overdraft facilities. Where restrictions are imposed by third parties, such as lending institutions, on cash balances held by the Group these are treated as financial assets in the financial statements.
xiv)
Certain share options have been granted for which there is a condition that the options only become exercisable into ADSs when the market price of an ADS reaches a certain level. This is deemed to be a non-vesting condition. The term ‘non-vesting condition’ is not explicitly defined in IFRS 2, Share based Payment, but is inferred to be any condition that does not meet the definition of a vesting condition. The only condition for these options to vest is that the option holder continues service and there were no other conditions which would be considered non-vesting conditions. Non-vesting conditions are reflected in measuring the grant-date fair value of the share-based payment and there is no true-up in the measurement of the share-based payment for differences between the expected and the actual outcome of non-vesting conditions. If all service conditions are met, then the share-based payment cost will be recognised even if the option holder does not receive the share-based payment due to a failure to meet the non-vesting condition.
The expense in the consolidated statement of operations in relation to share options represents the product of the total number of options anticipated to vest and the fair value of those options; this amount is allocated to accounting periods on a straight-line basis over the vesting period.
119
xv)
Government grants and financial support
The Group received government-backed Covid-19 financial supports in the form of forgivable loans. Under IAS 20, Accounting for Government Grants, a forgivable loan from government is treated as a government grant when there is reasonable assurance that the terms for forgiveness of the loan will be met. Where a loan was received in the financial year but not yet forgiven within the financial year, the loan is treated as a current liability. The Group has opted to present government grant income for loans that have been forgiven as Other operating income in the consolidated statement of operations.
If it is no longer reasonably assured that the terms of forgiveness will be met, any income previously recognised in respect of such a loan is reversed in the period in which the change in assessment occurs. Grants that compensate the Group for expenses incurred such as research and development, employment and training are recognised as income in the statement of operations on a systematic basis in the same periods in which the expenses are incurred. Grants that compensate the Group for the cost of an asset are recognised in the statement of operations on a systematic basis over the useful life of the asset. R&D tax credits claimed from tax authorities are credited to the taxation line in the consolidated statement of operations.
xvi)
Revenue recognition
Goods sold and services rendered
Some contracts oblige the Group to ship product to the customer ahead of the agreed payment schedule. For these shipments, a contract asset is recognised when control over the goods has transferred to the customer. The financing component is insignificant as invoicing for these shipments occurs within a short period of time after shipment has occurred and standard 30 day credit terms typically apply. Some contracts could be regarded as offering the customer a right of return. Due to the uncertainty of the magnitude and likelihood of product returns, there is a level of estimation involved in assessing the amount of revenue to be recognised for these types of contracts. In accordance with IFRS 15, when estimating the effect of an uncertainty on an amount of variable consideration to which the Group will be entitled, all information that is reasonably available, including historical, current and forecast, is considered.
Revenue is recognised on bill-and-hold transactions when all of the criteria in IFRS 15 are met, including: (i) the arrangement is at the customer’s request and has a substantive business reason; (ii) the products are separately identified as belonging to the customer; (iii) the products are ready for physical transfer to the customer; and (iv) the Group has no ability to use the products or redirect them to another customer. The Group assesses each bill-and-hold arrangement individually for compliance with these criteria. When all criteria are satisfied, control is deemed to have transferred and revenue is recognised.
The Group operates a licenced referenced laboratory in the US, which provides testing services to institutional customers and insurance companies. In the US, there are rules requiring all insurance companies to be billed the same amount per test. However, the amount that each insurance company pays for a particular test varies according to their own internal policies and this can typically be considerably less than the amount invoiced. We recognise lab services revenue for insurance companies by taking the invoiced amount and reducing it by an estimated percentage based on historical payment data. We review the percentage reduction annually based on the latest data. As a practical expedient, and in accordance with IFRS, we apply a portfolio approach to the insurance companies as they have similar characteristics. We judge that the effect on the financial statements of using a portfolio approach for the insurance companies will not differ materially from applying IFRS 15 to the individual contracts within that portfolio.
The Group leases diagnostic and analytical instruments to customers typically as part of a bundled package. Where a contract has multiple performance obligations and its duration is greater than one year, the transaction price is allocated to the performance obligations in the contract by reference to their relative standalone selling prices. For contracts where control of the instrument is transferred to the customer, the fair value of the instrument is recognised as revenue at the commencement of the lease and is matched by the related cost of sale. Fair value is determined on the basis of standalone selling price. In the case where control of the instrument does not transfer to the customer, revenue is recognised on the basis of customer usage of the instrument. See also Note 1 (v).
120
Revenue recognition (continued)
In obtaining these contracts, the Group incurs a number of incremental costs, such as sales bonus paid to sales staff commissions paid to distributors and royalty payments. As the amortisation period of these costs, if capitalised, would be less than one year, the Group makes use of the practical expedient in IFRS 15.94 and recognised them as expense as they are incurred.
Other operating income
Other operating income primarily includes items of income that arise outside the normal course of business, including government grant income from forgiven loans, insurance proceeds, sublease income, and other non-recurring items. Income is recognised when it is probable that the economic benefits associated with the transaction will flow to the Group and the amount can be measured reliably.
During the year ended December 31, 2025, other operating income also included gains arising from the remeasurement of contingent consideration liabilities to fair value. Such gains may arise where contingent obligations recognised on business combinations are reassessed and extinguished or lapse, and are recognised in profit or loss when the associated liability is derecognised or remeasured.
xvii)
Employee benefits
Defined contribution plans
The Group operates defined contribution schemes in various locations where its subsidiaries are based. Contributions to the defined contribution schemes are recognised in the statement of operations in the period in which the related service is received from the employee.
Other long-term benefits
Where employees participate in the Group’s other long-term benefit schemes (such as permanent health insurance schemes under which the scheme insures the employees), or where the Group contributes to insurance schemes for employees, the Group pays an annual fee to a service provider, and accordingly the Group expenses such payments as incurred.
Termination benefits
Termination benefits are recognised as an expense when the Group is demonstrably committed, without realistic possibility of withdrawal, to a formal detailed plan to either terminate employment before normal retirement date, or to provide termination benefits as a result of an offer made to encourage voluntary redundancy.
xviii)
Foreign currency
A majority of the revenue of the Group is generated in US Dollars. The Group’s management has determined that the US Dollar is the primary currency of the economic environment in which the Company and its subsidiaries (with the exception of the Group’s subsidiaries in Brazil, Canada and Sweden) principally operate. Thus, the functional currency of the Company and its subsidiaries (other than the Brazilian, Canadian and Swedish subsidiaries) is the US Dollar. The functional currency of the Brazilian entity is the Brazilian Real, the functional currency of the Swedish entity is the Swedish Krona and the functional currency of the Canadian subsidiary is the Canadian Dollar.
The presentation currency of the Company and Group is the US Dollar. Monetary assets and liabilities denominated in foreign currencies are translated at the rates of exchange ruling at the balance sheet date. The resulting gains and losses are included in the consolidated statement of operations. Non-monetary assets and liabilities that are measured in terms of historical cost in a foreign currency are translated using the exchange rate at the date of the transaction.
121
Foreign currency (continued)
Results and cash flows of subsidiary undertakings, which have a functional currency other than the US Dollar, are translated into US Dollars at average exchange rates for the year, and the related balance sheets have been translated at the rates of exchange ruling on the balance sheet date. Any exchange differences arising from the translations are recognised in the currency translation reserve via the statement of changes in equity.
Where Euro, Brazilian Real, Swedish Krona or Canadian Dollar amounts have been referenced in this document, their corresponding US Dollar equivalent has also been included and these equivalents have been calculated with reference to the foreign exchange rates prevailing at December 31, 2025.
xix)
Hedging
The activities of the Group expose it primarily to changes in foreign exchange rates and interest rates. The Group uses derivative financial instruments, from time to time, such as forward foreign exchange contracts to hedge these exposures.
The Group enters into forward contracts to sell US Dollars forward for Euro. The principal exchange risk identified by the Group is with respect to fluctuations in the Euro as a substantial portion of its expenses are denominated in Euro but its revenues are primarily denominated in US Dollars. The Group monitors its exposure to foreign currency movements and may use these forward contracts as cash flow hedging instruments whose objective is to cover a portion of this Euro expense.
At the inception of a hedging transaction entailing the use of derivatives, the Group documents the relationship between the hedged item and the hedging instrument together with its risk management objective and the strategy underlying the proposed transaction. The Group also documents its quarterly assessment of the effectiveness of the hedge in offsetting movements in the cash flows of the hedged items.
Derivative financial instruments are recognised at fair value. Where derivatives do not fulfil the criteria for hedge accounting, they are classified as held-for-trading and changes in fair values are reported in the statement of operations. The fair value of forward exchange contracts is calculated by reference to current forward exchange rates for contracts with similar maturity profiles and equates to the current market price at the balance sheet date.
The portion of the gain or loss on a hedging instrument that is deemed to be an effective cash flow hedge is recognised directly in the hedging reserve in equity and the ineffective portion is recognised in the statement of operations. As the forward contracts are exercised the net cumulative gain or loss recognised in the hedging reserve is transferred to the statement of operations and reflected in the same line as the hedged item.
xx)
Exchangeable notes and derivative financial instruments
The Company’s exchangeable notes are treated as a host debt instrument with embedded derivatives attached. On initial recognition, the host debt instrument is recognised at the residual value of the total net proceeds of the bond issue less fair value of the embedded derivatives. Subsequently, the host debt instrument is measured at amortised cost using the effective interest rate method.
The embedded derivatives are initially recognised at fair value and are restated at their fair value at each reporting date. The fair value changes of the embedded derivatives are recognised in the consolidated statement of operations, except for changes in fair value related to the Group’s own credit risk, which are recorded in the statement of comprehensive income.
Where the exchangeable notes are redeemed early or repurchased in a way that does not alter the original conversion privileges, the consideration paid is allocated to the respective components and the amount of any gain or loss is recognised in the consolidated statement of operations.
xxi)
The senior secured term loan is initially recorded at the fair value of the consideration received net of: a) directly attributable transaction costs, b) the fair value at the date of issue of the warrants issued to the lender (see Note 1xxii) and c) the fair value of the option to prepay the loan at the date of issue (see Note 1xxii).
Subsequent to initial recognition, the term loan is measured at amortised cost employing the effective interest methodology. Borrowing costs, including any penalties for early settlement of the loan, are recognised as an expense in the period in which they are incurred.
122
Senior secured term loan (continued)
In accordance with IFRS 9, the Group assesses any changes to the contractual terms of its borrowings to determine whether such changes result in a substantial modification. A modification is considered substantial if the revised cash flows differ significantly from those of the original arrangement, in which case the original liability is derecognised and a new financial liability is recognised. If a modification is not substantial, the loan is remeasured using the original EIR, with any resulting gain or loss recognised in profit or loss.
During 2024, the Group amended the terms of its senior secured term loan; however, this was assessed under IFRS 9 and determined not to constitute a substantial modification. In 2025, further changes to the Group’s debt arrangements resulted in the extinguishment of the existing liability and recognition of a new financial liability. Refer to Note 23 for further details.
xxii)
Warrants and loan prepayment option
The Company has issued warrants to third parties. A warrant contract might be accounted for as an equity instrument or a financial liability under IFRS depending on the terms of a warrant. A warrant contract that will or might be settled by an entity by delivering a fixed number of its own equity instruments, in exchange for a fixed amount of cash or another financial asset, is an equity instrument. As Perceptive has the option to choose a cashless exercise option, the Company will have to deliver a variable number of ADS, since the number of shares will vary depending on the ADS traded price. Even though the cashless exercise option is economically comparable to the cash exercise option, the fact that the Company will issue a variable number of shares under the cashless exercise option results in one settlement alternative violating the ‘fixed for fixed’ requirement. The warrant contract therefore meets the definition of a financial liability and given the value of the warrant changes in response to the price of the Company’s ADS, with no initial investment and settlement occurring in the future it meets the definition of a derivative liability under IFRS 9. The warrant is issued in a separate contract, is transferable independently of the term loan and can be exercised while the term loan remains outstanding. Therefore, the warrant is a separate instrument to the term loan.
The warrant contracts are initially recognised as a derivative liability at fair value and subsequently measured at fair value at each reporting period with any changes recognised in the consolidated statement of operations.
The Company has the option to prepay the senior secured term loan in whole or in part for an amount equal to the principal, accrued interest and prepayment premium. The prepayment premium is not solely compensation for time value of money or credit risk and, as a result, the prepayment option is not closely related to the debt host. In accordance with IFRS 9, this option is separated from the term loan and is initially recognised as a derivative asset at fair value and subsequently measured at fair value at each reporting period with any changes recognised in the consolidated statement of operations.
xxiii)
Convertible Note
The convertible note is accounted for as a compound financial instrument containing both an equity and liability element. The convertible note has a contractual obligation to deliver cash on redemption equal to the principal amount plus accrued interest and therefore has a liability component in line with the definition of a financial liability in IAS 32. The convertible loan note also has a conversion feature where it mandatorily converts into ADS if the volume weighted average price of the Company’s ADSs is at a certain price for any five consecutive NASDAQ trading days or any other time at the discretion of the Noteholder.
Where a conversion feature is settled by the exchange of a fixed amount of cash or another financial asset for a fixed number of the entity’s own equity instruments, the conversion feature represents an equity component of the convertible note. The equity component is measured as the residual amount that results from deducting the fair value of the liability component from the initial carrying amount of the instrument as a whole. There is no remeasurement of the equity element following initial recognition. The debt component is accounted for at amortised cost employing the effective interest methodology.
xxiv)
Segment reporting
Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision-maker. The chief operating decision-maker, who is responsible for allocating resources and assessing performance of the operating segments, has been identified as the Board of Directors.
xxv)
Tax (current and deferred)
Income tax on the profit or loss for the year comprises current and deferred tax. Income tax is recognised in the consolidated statement of operations except to the extent that it relates to items recognised directly in equity, in which case it is recognised in equity.
Current tax represents the expected tax payable or recoverable on the taxable profit for the year using tax rates enacted or substantively enacted at the balance sheet date in the countries where the company and its subsidiaries operate and generate income and taking into account any adjustments stemming from prior years.
123
Tax (current and deferred) (continued)
Deferred tax is provided on the basis of the balance sheet liability method on all temporary differences at the balance sheet date which is defined as the difference between the tax bases of assets and liabilities and their carrying amounts in the financial statements. Deferred tax assets and liabilities are not subject to discounting and are measured at the tax rates that are anticipated to apply in the period in which the asset is realised or the liability is settled based on tax rates and tax laws that have been enacted or substantively enacted at the balance sheet date. Deferred tax assets are recognised when it is probable that future taxable profits will be available to utilize the associated losses or temporary differences. The amount of deferred tax provided is based on the expected manner of realisation or settlement of the carrying amount of assets and liabilities.
Deferred tax assets and liabilities are recognised for all temporary differences (that is, differences between the carrying amount of the asset or liability and its tax base) with the exception of the following:
i. Where the deferred tax liability arises from goodwill not deductible for tax purposes or the initial recognition of an asset or a liability in a transaction that is not a business combination and affects neither the accounting profit nor the taxable profit or loss at the time of the transaction; and
ii. Where, in respect of temporary differences associated with investments in subsidiary undertakings, the timing of the reversal of the temporary difference is subject to control and it is probable that the temporary difference will not reverse in the foreseeable future.
Where goodwill is tax deductible, a deferred tax liability is not recognised on initial recognition of goodwill. It is recognised subsequently for the taxable temporary difference which arises when the goodwill is amortised for tax with no corresponding adjustment to the carrying value of the goodwill.
The carrying amounts of deferred tax assets are subject to review at each balance sheet date and are derecognised to the extent that future taxable profits are considered to be inadequate to allow all or part of any deferred tax asset to be utilised.
xxvi)
Provisions and contingent liabilities
A provision is recognised in the balance sheet when the Group has a present legal or constructive obligation because of a past event, and it is probable that an outflow of economic benefits will be required to settle the obligation. The status of any significant claim and legal proceeding in which the Group is involved is reviewed by management on a periodic basis and the Group’s potential financial exposure is assessed. If the potential loss from any claim or legal proceeding is considered probable, and the amount can be reliably estimated, a liability is recognised for the estimated loss.
Due to the uncertainties inherent in such matters, the related provisions are based on the best information available at the time. As additional information becomes available on pending claims, the potential liability is reassessed and revisions are made to the amounts accrued as appropriate. Such revisions in the judgments and estimates of the potential liabilities could have an impact on the results of operations and financial position of the Group in future accounting periods.
Provisions for restructuring costs are recognised only when the Group has approved a detailed formal plan and has either commenced implementation or raised a valid expectation among those affected that the restructuring will be carried out. Under IAS 37, restructuring provisions must only include direct expenditures that are necessarily incurred by the restructuring and not associated with the ongoing activities of the business.
xxvii)
Cost of sales comprises product cost including manufacturing and payroll costs, quality control, shipping, handling, and packaging costs and the cost of services provided.
xxviii)
Finance income and costs
Financing expenses comprise interest costs payable on senior secured term loan, convertible note, leases and exchangeable notes along with non-recurring financing expenses such as penalty for early settlement of term loan and loss on disposal of exchangeable notes. Interest payable on finance leases is allocated to each period during the lease term so as to produce a constant periodic rate of interest on the remaining balance of the liability. Financing expenses also includes the financing element of long term liabilities which have been discounted. Finance income includes interest income on deposits and is recognised in the consolidated statement of operations as it accrues, using the effective interest method. Finance income also includes fair value adjustments for derivative assets and liabilities related to the senior secured term loan and to embedded derivatives associated with exchangeable notes.
xxix)
When the Group purchases its own equity instruments (treasury shares), the costs, including any directly attributable incremental costs, are deducted from equity. No gain or loss is recognised in the consolidated statement of operations on the purchase, sale, issue or cancellation of the Group’s own equity instruments. Any difference between the carrying amount and the consideration, if reissued, is recognised in share premium. Voting rights related to treasury shares are nullified for the Group and no dividends are allocated to them.
124
xxx)
Equity
Share capital represents the nominal (par) value of shares that have been issued. Share premium includes any premiums received on issue of share capital. Any transaction costs associated with the issuing of shares are deducted from share premium, net of any related income tax benefits.
xxxi)
Profit or loss from discontinued operations
A discontinued operation is a component of the Group that either has been disposed of or is classified as held for sale. Profit or loss from discontinued operations comprises the post-tax profit or loss of discontinued operations and the post-tax gain or loss resulting from the measurement and disposal of assets classified as held for sale and any gain or loss on disposal.
xxxii)
Fair values
For financial reporting purposes, fair value measurements are categorized into Level 1, 2 or 3 based on the degree to which inputs to the fair value measurements are observable and the significance of the inputs to the fair value measurement in its entirety, which are described as follows:
Level 1: quoted prices (unadjusted) in active markets for identical assets or liabilities
Level 2: valuation techniques for which the lowest level of inputs which have a significant effect on the recorded fair value are observable, either directly or indirectly
Level 3: valuation techniques for which the lowest level of inputs that have a significant effect on the recorded fair value are not based on observable market data
xxxiii)
New IFRS Standards
The following new accounting standards and interpretations became effective for annual periods beginning on or after 1 January 2025. The adoption of these standards did not have a material impact on the Group’s consolidated financial statements:
IAS 21 (Amendments) – Lack of Exchangeability; new guidance on assessing exchangeability, estimating spot rates, and enhanced disclosures.
The Company is currently assessing the impact of the new standards and amendments on the Company’s accounting policy disclosure.
xxxiv)
Standards, amendments and interpretations to existing IFRS Standards that are not yet effective
The standards and amendments that have been issued but are not yet effective as at the date of issuance of the financial statements, and which may have an impact on the Group's financial statements in future periods, are listed below. The Group intends to adopt these standards, if applicable, when they become effective:
Amendments to the Classification and Measurement of Financial Instruments (Amendments to IFRS 9 and 7), effective from 1 January 2026
Annual Improvements to IFRS Accounting Standards, effective from 1 January 2026
Contracts Referencing Nature-dependent Electricity (IFRS 9/IFRS 7)
IFRS 18 ‘Presentation and Disclosure in Financial Statements’, effective from 1 January 2027
IFRS 19 ‘Subsidiaries without Public Accountability: Disclosures’, effective from 1 January 2027
Sale or Contribution of Assets between an Investor and its Associate or Joint Venture (Amendments to IFRS 10 and IAS 28)
125
2.
SEGMENT INFORMATION
Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision-maker. The chief operating decision-maker, who is responsible for allocating resources and assessing the performance of the operating segments, has been identified as the Board of Directors. Management has determined the operating segments based on the reports reviewed by the Board of Directors, which are used to make strategic decisions. The Board considers the business from a geographic perspective based on the Group’s management and internal reporting structure. Sales of product between companies in the Group are made on commercial terms which reflect the nature of the relationship between the relevant companies. Segment results, assets and liabilities include items directly attributable to a segment as well as those that can be allocated on a reasonable basis. Unallocated items comprise interest-bearing loans, borrowings and expenses and corporate expenses. Segment capital expenditure is the total cost during the year to acquire segment plant, property and equipment and intangible assets that are expected to be used for more than one period, whether acquired on acquisition of a business combination or through acquisitions as part of the current operations.
The Group comprises two main geographical segments (i) the Americas and (ii) Rest of World - Ireland. The Group’s geographical segments are determined by the location of the Group’s assets and operations. The Group has also presented a geographical analysis of the segmental data for Ireland as is consistent with the information used by the Board of Directors.
The reportable operating segments derive their revenue primarily from one source (i.e., the market for diagnostic tests for a range of diseases and other medical conditions). In determining the nature of its segmentation, the Group has considered the nature of the products, their risks and rewards, the nature of the production base, the customer base and the nature of the regulatory environment. The Group acquires, manufactures and markets a range of diagnostic products. The Group’s products are sold to a similar customer base and the Group’s products must comply with various regulators worldwide in the markets that we serve.
The following presents revenue and profit information and certain asset and liability information regarding the Group’s geographical segments.
The distribution of revenue by geographical area based on location of assets was as follows:
Revenue
Rest of World Ireland
Eliminations
Revenue from external customers
32,390
11,395
Inter-segment revenue
19,586
3,606
(23,192)
Total revenue
51,976
15,001
41,792
19,763
19,815
702
(20,517)
61,607
20,465
44,984
11,848
21,867
872
(22,739)
66,851
12,720
126
SEGMENT INFORMATION (CONTINUED)
The distribution of revenue by customers’ geographical area was as follows:
December 31, 2025
December 31, 2024
December 31, 2023
Asia / Africa
Europe (including Ireland) *
Revenue from customers in Ireland is not disclosed separately due to the immateriality of these revenues.
The distribution of revenue by major product group was as follows:
The group has recognised the following amounts relating to revenue in the consolidated statement of operations:
Revenue from contracts with customers
(v)
Disaggregation of revenue from contracts with customers:
The Group derives revenue from the transfer of goods and services over time and at a point in time in the following geographical areas:
Rest of World
Timing of revenue recognition
At a point in time
31,949
43,344
Over time
41,536
61,299
256
44,692
56,540
292
127
(vi)
The Group derives revenue from the transfer of goods and services over time and at a point in time based on customers’ geographical area as follows:
24,182
43,343
442
29,661
31,990
(vii)
The distribution of segment results by geographical area was as follows:
Result before transformation costs, impairment and unallocated expenses
(1,291)
(5,639)
(327)
(7,257)
Transformation costs
(1,241)
(3,011)
Result after impairment
(4,709)
(8,650)
(13,686)
Unallocated expenses *
(2,103)
Net financing expense (Note 6)
Income tax charge (Note 7)
Loss for the year on discontinued operations (Note 8)
128
(9,386)
(315)
(12,204)
(2,025)
(2,156)
(612)
(796)
(5,140)
(12,338)
(17,793)
(3,372)
(4,365)
(7,886)
(104)
(12,355)
(15,470)
(23,460)
(3,585)
Income tax credit (Note 7)
Profit for the year on discontinued operations (Note 8)
Unallocated expenses represent head office general and administration costs of the Group, which cannot be allocated to the results of any specific geographical area.
The distribution of segment assets and segment liabilities by geographical area was as follows:
As at December 31, 2025
Assets and liabilities
Segment assets
35,219
60,404
95,647
Unallocated assets:
Income tax assets (current and deferred)
4,380
Cash and cash equivalents and short-term investments
Total assets as reported in the Group balance sheet
Segment liabilities
129,073
43,033
172,132
Unallocated liabilities:
Income tax liabilities (current and deferred)
5,015
Total liabilities as reported in the Group balance sheet
129
As at December 31, 2024
32,798
61,254
94,052
4,071
84,863
48,621
133,546
4,925
The distribution of long-lived assets, which are property, plant and equipment, goodwill and intangible assets and other non-current assets (excluding deferred tax assets and derivative financial instruments), by geographical area was as follows:
Rest of World – Ireland
44,110
43,504
20,980
14,943
65,090
58,447
The distribution of depreciation and amortisation by geographical area was as follows:
Depreciation:
153
160
162
1,146
515
668
830
Amortisation:
796
770
458
589
420
487
945
The distribution of share-based payment expense by geographical area was as follows:
215
843
1,650
473
419
See Note 20 for further information on share-based payments.
130
The distribution of taxation (expense)/credit by geographical area was as follows:
171
(385)
Rest of World – Other
(6)
(235)
(364)
(490)
679
During 2025, 2024 and 2023 there were no customers generating 10% or more of total revenues.
The distribution of capital expenditure by geographical area was as follows:
8,848
37,929
2,389
2,753
11,237
40,682
Capital expenditure for the year ended December 31, 2025 includes additions arising from CGM and Metabolomics Diagnostic Limited (see Note 29). In addition, capitalised development costs decreased from US$8.6 million in 2024 to US$6.3 million in 2025.
3.
EMPLOYMENT
The average number of persons employed by the Group in continuing operations is as follows:
Research and development
Administration and sales
Manufacturing and quality
190
286
258
The average number of employees, including discontinued operations, was 287 (2024: 401; 2023: 383).
Employment costs charged in the consolidated statement of operations for continuing operations are analysed as follows:
Wages and salaries
18,804
25,570
23,718
Social welfare costs
1,916
2,219
2,061
Pension costs
355
451
508
Transformation cost
596
485
21,552
30,152
28,841
131
EMPLOYMENT (CONTINUED)
Total employment costs, inclusive of amounts capitalised for wages and salaries, social welfare costs and pension costs, for the year ended December 31, 2025, amounted to US$24,046,000 (2024: US$33,584,000) (2023: US$29,975,000). Total share-based payments amounted to US$324,000 for the year ended December 31, 2025 (2024: US$1,316,000) (2023: US$2,069,000). See Note 20 for further details.
Employment costs including discontinued operations, are analysed as follows:
24,343
2,097
510
29,504
The Group operates defined contribution pension schemes for certain of its full-time employees. The benefits under these schemes are financed by both Group and employee contributions. Total contributions made by the Group in the financial year and charged against income in respect of continuing operations amounted to US$355,000 (2024: US$451,000) (2023: US$508,000). The pension accrual for the Group at December 31, 2025 was US$147,000 (2024: US$nil) (2023: US$56,000).
4.
OTHER OPERATING INCOME / (EXPENSE)
Other income
138
Rental income from premises
Government supports
(1,827)
Fair value gain on contingent consideration
As part of the acquisition for the continuous glucose monitoring (“CGM”) assets, the Group recognised a contingent consideration liability to Perceptive in respect of commercial partnering agreements with certain glucose pump manufacturers (see Note 29). The fair value assigned to this contingent consideration at acquisition was US$1.9 million, with this item disclosed as a contingent liability as at December 31, 2024.
In December 2025, as part of a broader restructuring and amendment of the Perceptive term loan facility, which also addressed contingent consideration obligations arising in connection with the Waveform acquisition and included the introduction of a conversion feature (refer to Note 23 for further details), the Group reassessed the contingent consideration. At the amendment date, the contractual trigger period for the partnering milestone had less than six weeks remaining, and no commercial discussions or actions were underway that could reasonably be expected to result in the milestone being achieved within the remaining period. Management therefore concluded that the probability‑weighted expected payoff was insignificant and, as a result, the fair value of the contingent consideration was assessed as being materially close to nil and the liability was remeasured to US$nil. The remeasurement of the contingent consideration liability to US$nil resulted in the recognition of a US$1.9 million gain in other operating income.
Government Support
In October 2024, the Company received an inquiry from a U.S. governmental authority concerning second‑round Paycheck Protection Program (PPP) loans received by certain U.S. subsidiaries. At December 31, 2024, a payable of US$2,165,000 was recognised, covering the US$1,827,000 in loans and estimated interest of US$338,000. As the original loan income was recognised in other operating income, the reversal to the extent of the loan to be repaid has been recorded as a corresponding charge to other operating (expense)/income, noted as “Government supports”. The interest costs incidental to the loan repayment has been charged to finance costs.
A settlement was reached during 2025 with respect to the PPP loans. No additional amounts were recognised within other operating (expense)/income during the year. As a result of the settlement, a partial reversal of the previously recognised provision was recorded, giving rise to a credit of US$0.2 million within once‑off costs (Note 5). In addition, a reversal of previously accrued interest of approximately US$0.2 million was recognised within financial expenses (Note 6).
132
5.
IMPAIRMENT, TRANSFORMATION AND ONCE OFF COSTS
During the year ended December 31, 2025, the Group continued with its comprehensive business transformation program (the program has been in effect since FY 2024) aimed at improving long-term operational efficiency and aligning the organization with its strategic priorities. These changes were previously communicated to the market and include operationally profitability measures, organizational realignment, and changes to business unit structures.
As a result, the Group recognized transformation costs of US$4.3 million (2024: US$4.2 million) (2023: US$nil) which are presented separately in the consolidated statement of operations within ‘Selling, general and administrative expenses – Transformation costs’.
The transformation costs incurred during the year comprised the following:
Nature of cost
Personnel related costs
261
1,216
Outsourcing costs
754
Site transfer costs
714
1,281
Inventory related costs
772
Other transformation costs
158
Total transformation costs
975
4,181
Stranded costs
3,277
4,252
Transformation costs recognised during the year ended December 31, 2025 include US$3.3 million of fixed overheads associated with certain manufacturing facilities that were not absorbed within cost of sales as a result of reduced production volumes during the period. These costs arose in connection with the consolidation and outsourcing of manufacturing activities undertaken as part of the Group’s Comprehensive Transformation Plan. Such costs primarily reflect under‑absorbed fixed overheads during the transition phase as manufacturing volumes were reallocated between sites and outsourced partners. The Group expects these stranded costs to reduce as manufacturing transitions are completed and production volumes stabilise under the revised operating model, although residual costs may continue to be incurred during 2026.
Included within Site transfer costs above is US$0.2 million (2024: US$0.4 million) related to the impairment of plant & equipment arising as part of the transformation program. Refer to Note 11. We have provided for additional transformation costs of US$1.1 million as at December 31, 2025 (see Note 22).
IMPAIRMENT, TRANSFORMATION AND ONCE OFF COSTS (CONTINUED)
Once off costs
During the year ended 31 December 2025, the Company recorded a gain in exceptional, non-trading costs totaling US$0.2 million (2024: charge of $1.9 million).
During 2024, the Company recognized a provision of US$0.7 million in respect of the investigation relating to Paycheck Protection Program (PPP) loans received by certain U.S. subsidiaries. Following the settlement of this matter during 2025, a portion of the previously recognised provision was reversed, resulting in a gain of US$0.2 million recognised within once‑off items. Further details of the settlement are disclosed in Note 4.
In October 2024, the Company issued 650,000 American Depositary Shares (“ADSs”) to a corporate finance advisor as a non-refundable retainer fee in respect of advisory services provided in connection with a planned future equity raise. The fair value of the ADSs issued, amounting to US$1.1 million, was recognized directly in equity, with a corresponding charge recorded within the consolidated statement of operations as an exceptional cost.
In accordance with IAS 36, Impairment of Assets, the Company carries out periodic impairment reviews of the asset valuations. A number of factors impacted this calculation including the Company’s market capitalization during the year ended December 31, 2025, the cost of capital, cash flow projections and net asset values across each of the Company’s cash-generating units.
The impact of the above items on the consolidated statement of operations for the year ended December 31, 2025, 2024, and 2023 are as follows:
Selling, general & administration expenses
Impairment of PP&E (Note 11)
Impairment of goodwill and other intangible assets (Note 12)
(Reversal)/Impairment of financial assets (Note 13)
Total impairment loss
2,177
1,408
11,105
Premier Resolution
Premier Resolution is a capitalized intangible asset held within Primus Corporation and relates to the Resolution platform for haemoglobinopathy and variant testing in the US market. While the platform has achieved technical feasibility and obtained FDA clearance in late 2023, the commercialization pathway is dependent on securing adoption within a highly concentrated US reference laboratory market.
While the Group continues to pursue commercial opportunities for the platform and believes that it retains underlying potential, these factors have resulted in the recoverable amount of the asset being lower than its carrying value. Accordingly, the Group recognized a partial impairment charge of US$2.1 million during the year.
134
6.
FINANCIAL INCOME AND EXPENSES
Financial income:
Non-cash financial income
Financial expense:
Interest on leases (Note 24)
(644)
(592)
(624)
Loss on extinguishment on old loan (Note 23)
(9,999)
Penalty for early partial settlement of senior secured term loan (Note 23)
Cash interest payable on senior secured term loan
(6,293)
(7,289)
Cash interest payable on convertible note
Cash interest on exchangeable notes
Cash interest payable on PPP loans (Note 4)
221
(338)
Non-cash interest on senior secured term loan (Note 23)
(2,646)
(2,355)
(1,131)
Non-cash interest on convertible note (Note 23)
(929)
(859)
Non-cash financial expense
(202)
(1,172)
Unwinding of discount on deferred contingent consideration
(87)
(53)
Capitalisation of borrowing costs (Note 12)
2,899
2,085
Non-cash loan modification gain (Note 23,28)
1,706
3,567
Payment-in-kind (PIK) Interest (Note 23)
(11,399)
(3,247)
For more information on the senior secured term loan, convertible note and exchangeable notes, refer to Note 23 Interest-Bearing Loans and Borrowings.
Non-cash financial expense relates to the fair value loss on warrant liabilities during the year. Refer to Note 23 for further details.
7.
INCOME TAX (EXPENSE)/CREDIT
Current tax expense/(credit)
Irish Corporation tax
(154)
Foreign taxes (a)
290
254
462
Adjustment in respect of prior years
329
(198)
Total current tax expense/(credit)
465
285
264
Deferred tax credit (b)
Origination and reversal of temporary differences (see Note 14)
(266)
(41)
(547)
Origination and reversal of net operating losses (see Note 14)
242
224
Total deferred tax (credit)/charge
201
(323)
Total income tax charge/(credit) on continuing operations in statement of operations
Tax charge on discontinued operations (see Note 8)
Total tax charge/(credit)
(a)
In 2025, the foreign taxes relate primarily to USA and Canada.
(b)
In 2025, there was a deferred tax credit of US$28,000 (2024: credit of US$43,000) (2023: charge of US$174,000) recognised in respect of Ireland and a deferred tax credit of US$238,000 (2024: charge of US$244,000) (2023: credit of US$497,000) recognised in respect of overseas tax jurisdictions.
Effective tax rate
Loss before taxation – continuing operations (US$‘000)
As a percentage of loss before tax:
Current tax %
(1.25)
(0.93)
(0.72)
Total (current and deferred) %
(0.54)
(1.58)
(0.16)
135
INCOME TAX (EXPENSE)/CREDIT (CONTINUED)
The following table reconciles the applicable Republic of Ireland statutory tax rate to the effective total tax rate for the Group:
Irish corporation tax
(12.50)
Effect of current year net operating losses and temporary differences for which no deferred tax asset was recognised (a)
20.86
15.89
17.19
Effect of tax rates on overseas earnings
(10.97)
6.63
(7.82)
Effect of Irish income taxable at higher tax rate
3.84
(4.09)
2.62
Adjustments in respect of prior years
0.89
0.04
(0.53)
R&D tax credits
(0.46)
Other items (b)
(2.20)
(7.55)
0.88
No deferred tax asset was recognised because there was no reversing deferred tax liability in the same jurisdiction reversing in the same period and insufficient future projected taxable income in the same jurisdiction.
Other items comprise items not chargeable to tax and expenses not deductible for tax purposes.
The distribution of loss before taxes by geographical area was as follows:
(12,490)
(17,296)
(12,922)
(24,360)
(13,119)
(23,901)
At December 31, 2025, the Group had unutilised net operating losses for continuing operations as follows:
102,751
107,093
69,851
51,678
52,852
52,511
26,707
22,866
13,840
181,136
182,811
136,202
At December 31, 2025, the Group had unrecognised deferred tax assets in respect of unused tax losses and unused tax credits as follows:
Rest of World – Ireland – unused tax losses
13,725
13,275
8,464
Rest of World – Other – unused tax losses
14,465
14,777
14,701
Americas – unused tax losses
2,149
3,395
Americas – unused tax credits
6,813
5,702
5,806
Unrecognised deferred tax asset
37,152
35,903
32,366
The accounting policy for deferred tax is to calculate the deferred tax asset that is deemed recoverable, considering all sources for future taxable profits. The deferred tax assets in the above table have not been recognised due to uncertainty regarding the full utilization of these losses in the related tax jurisdiction in future periods. Only when it is probable that future profits will be available to utilize the forward losses or temporary differences is a deferred tax asset recognised. When there is a reversing deferred tax liability in that jurisdiction that reverses in the same period, the deferred tax asset is restricted so that it equals the reversing deferred tax liability.
136
8.
(LOSS)/PROFIT FOR THE YEAR ON DISCONTINUED OPERATIONS
In April 2023, the Company announced the sale of its Fitzgerald Industries life sciences supply business, consisting of Benen Trading Ltd and Fitzgerald Industries International, Inc, to Biosynth for cash proceeds of approximately US$30 million subject to customary adjustments. The results of Fitzgerald Industries were presented as discontinued operations in the 2023 financial statements.
During 2024, the Company recognised additional costs related to the 2023 disposal of Fitzgerald Industries, following a settlement agreement with Biosynth that was finalised prior to year-end and formally signed in January 2025. A provision of US$150,000 was recorded in respect of the full and final settlement of all post-completion claims. In addition, outstanding receivables of US$423,000 from Biosynth relating to completion account adjustments were written off as unrecoverable under the terms of the settlement.
The operating (loss)/profit for the discontinued operations are summarised as follows:
2,784
Operating expenses
(2,652)
Tax expense (Note 7)
Profit from operating activities
(Loss)/Gain on sale of discontinued operations
12,718
(Loss)/Profit for the year from discontinued operations
There were no discontinued operations in the year ended December 31, 2025 (2024: US$0.6 million). Accordingly, there are no earnings per share from discontinued operations for the year ended December 31, 2025.
The net cashflows generated from discontinued operations are as follows:
Cash received from sale of the discontinued operations net of transaction costs
28,935
Cash sold as a part of discontinued operations
(775)
Net cash inflow on date of disposal
During 2024, the Biosynth transactions were recognised as post-disposal adjustments, reflecting the write-off of receivables and provision for settlement costs.
Net assets disposed in 2023
Post disposal adjustment in 2024
Net assets disposed/adjusted as on 31 December 2024
Property plant & equipment
14,123
Inventory
1,160
Cash
775
1,309
(423)
(864)
(150)
(1,014)
(106)
Current corporation tax
Deferred tax liability
(195)
Total net assets disposed
16,303
15,730
137
(LOSS)/PROFIT FOR THE YEAR ON DISCONTINUED OPERATION (CONTINUED)
Basic (loss)/earnings per ordinary share – discontinued operations
Basic (loss)/earnings per ordinary share for discontinued operations is computed by dividing the profit/ (loss) after taxation on discontinued operations of US$Nil, (2024: Loss of US$573,000) (2023: Profit of US$12,850,000) for the financial year by the weighted average number of ‘A’ ordinary shares in issue as at December 31, 2025, this amounted to 371,513,458 shares (2024: 359,193,482 shares) (2023: 153,099,405 shares), see Note 10 for further details.
Diluted (loss)/earnings per ordinary share – discontinued operations
Diluted (loss)/earnings per ordinary share for discontinued operations is computed by dividing the profit/ (loss) after taxation on discontinued operations of US$Nil, (2024: Loss of US$573,000) (2023: Profit of US$12,850,000) for the financial year by the diluted weighted average number of ordinary shares in issue of 488,155,270 shares (2024: 404,096,277 shares) (2023: 178,016,062 shares), see Note 10 for further details.
Basic (loss)/earnings per ‘A’ share (US Dollars) – discontinued operations
(0.00)
0.08
Diluted (loss)/earnings per ‘A’ share (US Dollars) – discontinued operations
0.07
Basic (loss)/earnings per ADS – discontinued operations
Basic earnings per ADS for discontinued operations is computed by dividing the profit/(loss) after taxation on discontinued operations of US$Nil, (2024: Loss of US$573,000) (2023: Profit of US$12,850,000) for the financial year by the weighted average number of ADS in issue of 18,575,673 (2024: 17,959,674) (2023: 7,654,970), see Note 10 for further details.
Diluted (loss)/earnings per ADS – discontinued operations
Diluted earnings per ADS for discontinued operations is computed by dividing the profit/ (loss) after taxation on discontinued operations of US$Nil, (2024: Loss of US$573,000) (2023: Profit of US$12,850,000) for the financial year, by the diluted weighted average number of ADS in issue of 24,407,764 (2024: 20,204,814) (2023: 8,900,803), see Note 10 for further details.
Basic (loss)/earnings per ADS (US Dollars) – discontinued operations
(0.03)
1.68
Diluted (loss)/earnings per ADS (US Dollars) – discontinued operations
1.44
Cash flows
The cash flows attributable to discontinued operations are as follows:
Cash (outflow) from operating activities
(177)
Cash inflow from investing activities
Cash outflow from financing activities
9.
LOSS BEFORE TAX
The following amounts were charged / (credited) to the statement of operations:
Directors’ emoluments (including non- executive directors):
Remuneration
1,327
1,454
2,058
Pension
Share based payments (Note 26)
149
931
1,601
Auditor’s remuneration
Audit fees
1,161
1,082
861
Tax fees
175
407
Depreciation (Note 11) 1
Amortisation (Note 12)
Net foreign exchange differences
494
376
336
1 In 2025, US$249,000 was capitalised to research and development projects (2024: US$204,000) (2023: US$Nil).
Depreciation for discontinued operations for the year ended December 31, 2025 is US$Nil (2024: US$Nil) (2023:US$1,000)
Amortisation for discontinued operations for the year ended December 31, 2025 is US$Nil (2024: US$Nil) (2023:US$1,000).
10.
LOSS PER SHARE
Basic loss per ordinary share
Basic loss per ordinary share is calculated by dividing the net loss attributable to owners of the parent of US$37,376,000 (2024: loss of US$31,789,000) (2023: loss of US$24,018,000) by the weighted average number of ‘A’ ordinary shares in issue, net of any Treasury Shares, during the year. Basic loss per ordinary share from continuing operations is calculated by dividing the loss from continuing operations attributable to owners of the parent of US$37,376,000 (2024: loss of US$31,216,000) (2023: loss of US$36,868,000) by the weighted average number of ‘A’ ordinary shares in issue, net of any Treasury Shares, during the year.
As at December 31, 2025, the number of ‘A’ ordinary shares for the purposes of the calculation of basic loss per share are 371,513,458 shares (2024: 359,193,482 shares) (2023: 153,099,405 shares).
‘A’ ordinary shares
371,513,458
359,193,482
153,099,405
Basic loss per share denominator
Reconciliation to weighted average loss per share denominator:
Number of ‘A’ ordinary shares at January 1 (Note 19)
371,749,080
165,865,882
164,985,882
Weighted average number of ‘A’ ordinary shares issued during the year*
12,319,978
205,883,200
669,123
Weighted average number of treasury shares
(12,555,600)
*The weighted average number of shares issued during the year is calculated by taking the number of shares issued multiplied by the number of days in the year each share is in issue, divided by 365 days.
Diluted loss per ordinary share
Diluted loss per ordinary share is calculated by dividing the net loss attributable to owners of the parent by the weighted average number of ‘A’ ordinary shares in issue, net of any Treasury Shares, during the year, plus the weighted average number of ‘A’ ordinary shares that would be issued on the conversion of all the dilutive potential ‘A’ ordinary shares into ‘A’ ordinary shares. As the potentially dilutive instruments were anti-dilutive in all periods presented, basic loss per ‘A’ ordinary share and diluted loss per ‘A’ ordinary share are equivalent.
The following potential ‘A’ ordinary shares are anti-dilutive and are therefore excluded from the weighted average number of ‘A’ ordinary shares for the purposes of calculating diluted loss per ‘A’ ordinary share.
139
LOSS PER SHARE (CONTINUED)
Potentially Dilutive Instruments:
Issuable on exercise of options (Note 20)
186,908
Issuable on exercise of warrants to Perceptive (Note 23)
57,200,000
20,173,151
Issuable on exercise of conversion options to Perceptive (Note 23)
34,712,063
Issuable on conversion of Exchangeable notes (Note 23)
38,391
Issuable on conversion of Convertible notes (Note 23)
24,691,358
Total number of potentially dilutive instruments excluded from the weighted average number of ‘A’ ordinary shares in calculating dilutive loss per ‘A’ ordinary share
116,641,812
44,902,900
24,916,657
Of the ‘A’ ordinary shares issuable on exercise of options, nil are contingently issuable as their issue is contingent upon satisfaction of specified performance conditions in addition to the passage of time. The conditions governing their exercisability have not been satisfied as at the end of the reporting period.
Potential ordinary shares arising from the Perceptive financing arrangements, including conversion options subject to share price conditions, are contingently issuable under IAS 33. These instruments have been excluded from diluted earnings per share as the Group incurred losses in all periods presented and their inclusion would be anti‑dilutive.
Loss per ADS
In February 2024, the Company changed the ratio of the ADSs representing its ‘A’ ordinary shares from one (1) ADS representing four (4) ‘A’ ordinary shares to one (1) ADS representing twenty (20) ‘A’ ordinary shares.
Basic loss per ADS is calculated by dividing the loss attributable to owners of the parent of US$37,376,000 (2024: loss of US$31,789,000) (2023: loss of US$24,018,000) by the weighted average number of ADS in issue, net of any Treasury Shares, during the year. Basic loss per ADS from continuing operations is calculated by dividing the loss of US$37,376,000 (2024: loss of US$31,216,000) (2023: loss of US$36,868,000) by the weighted average number of ADS in issue, net of any Treasury Shares, during the year.
As at December 31, 2025, the number of ADS for the purposes of the calculation of basic loss per ADS were 18,575,673 ADS (2024: 17,959,674 ADS) (2023: 7,654,970 ADS).
18,575,673
17,959,674
7,654,970
Basic loss per ADS denominator
Reconciliation to weighted average loss per ADS denominator:
Number of ADS at January 1 (Note 19)
18,587,454
8,293,294
8,249,294
Weighted average number of shares issued during the year*
615,999
10,294,160
33,456
(627,780)
*The weighted average number of ADSs issued during the year is calculated by taking the number of ADSs issued multiplied by the number of days in the year each share is in issue, divided by 365 days.
140
Diluted loss per ADS
Diluted loss per ADS is calculated by dividing the net loss attributable to owners of the parent by the weighted average number of ADS in issue, net of any Treasury Shares, during the year, plus the weighted average number of ADS that would be issued on the conversion of all the dilutive potential ADS into ADS. As the potentially dilutive instruments were anti-dilutive in all periods presented, basic loss per ADS and diluted earnings per ADS are equivalent.
The following potential ADS are anti-dilutive and are therefore excluded from the weighted average number of ADS for the purposes of calculating dilutive (loss)/earnings per ADS.
9,345
2,860,000
1,008,658
1,735,603
1,920
1,234,568
Total number of potentially dilutive instruments excluded from the weighted average number of ADS in calculating dilutive loss per ADS
5,832,091
2,245,146
1,245,833
Of the ADS issuable on exercise of options, NIL are contingently issuable as their issue is contingent upon satisfaction of specified performance conditions in addition to the passage of time. The conditions governing their exercisability have not been satisfied as at the end of the reporting period.
Potential ordinary ADS arising from the Perceptive financing arrangements, including conversion options subject to share price conditions, are contingently issuable under IAS 33. These instruments have been excluded from diluted earnings per share as the Group incurred losses in all periods presented and their inclusion would be anti‑dilutive.
11.
PROPERTY, PLANT AND EQUIPMENT
Land & Buildings
Leasehold Improvements
Computer & Office Equipment
Plant & Equipment, Vehicles
Cost
At January 1, 2024
24,268
2,760
4,612
34,429
66,069
Additions #
752
150
478
1,380
Additions through acquisition (Note 29)
582
740
1,373
Disposals or retirements
(14)
Remeasurement of ROU assets
1,764
Reallocations/ reclassifications
At December 31, 2024
26,784
2,811
5,344
35,686
70,625
At January 1, 2025
1,777
408
2,202
At December 31, 2025
28,561
2,826
5,346
36,092
72,825
Accumulated depreciation and Impairment losses
(24,022)
(2,669)
(4,349)
(33,137)
(64,177)
Charge for the year (Note 9)
(325)
(58)
(283)
(9)
(675)
Impairment losses*
(410)
(80)
(477)
(968)
Exchange adjustments
(179)
(24,757)
(2,728)
(4,717)
(33,802)
(66,004)
(720)
(66)
(499)
(1,299)
(217)
(220)
(25,477)
(2,744)
(4,784)
(34,518)
(67,523)
Carrying amounts
3,084
562
1,574
2,027
627
The assets of the Group are pledged as security for the senior secured term loan from Perceptive Advisors.
# Additions include US$2.1 million in additions to ROU assets (2024: US$0.9 million).
* The total impairment charge recognised against Property, Plant & Equipment during the year was US$ 220,000 (2024: US$ 968,000). which pertains to plant and equipment, vehicles as described above, of which is US$33,000 is presented within ‘Impairment Charges’ in the Consolidated Statement of Operations. The remaining US$187,000 is included within ‘Transformation Costs’ (see Note 5).
In 2024, remeasurement of ROU assets during the year included adjustments arising from rent reviews on leased properties in Bray, Ireland. These relate to leases with a related party, Mr. O’Caoimh, and reflect revised future lease payments following independent valuations. Further details are provided in Note 26 – Related Party Transactions
142
PROPERTY, PLANT AND EQUIPMENT (CONTINUED)
Right-of-use assets
Additional information on the right-of-use assets by class of assets is as follows:
Carrying amount At December 31, 2025
Depreciation Charge Year ended December 31, 2025
Impairment Charge Year ended December 31, 2025
US$000
Buildings
3,215
Computer and office equipment
(52)
Plant and equipments
(25)
3,547
(797)
Carrying amount At December 31, 2024
Depreciation Charge Year ended December 31, 2024
Impairment Charge Year ended December 31, 2024
2,126
(356)
(56)
(43)
2,198
(381)
(399)
Right-of-Use assets at 31 December 2025
No. of Right-of-Use leased assets
Range of remaining term in years
Average remaining lease term (years)
No. of Leases with extension options
No. of Leases with options to purchase
No. of leases with variable payments linked to index
No. of leases with termination options
Building
0 to 8
Vehicle
1 to 3
I.T. and office equipment
1 to 4
Right-of-Use assets at 31 December 2024
0 to 9
0 to 2
2 to 5
The details of the impairment review are described in Note 12. When an impairment loss is identified in a cash-generating unit, it must be first allocated to reduce the carrying amount of any goodwill allocated to the cash-generating unit and then to the other assets of the unit pro rata on the basis of the carrying amount of each asset in the unit. In this manner, an impairment loss of US$0.2 million was allocated to property, plant and equipment as at December 31, 2025 (2024: US$0.6 million). The recoverable amount of property, plant and equipment was determined to be the value in use of each cash-generating unit.
12.
GOODWILL AND INTANGIBLE ASSETS
Goodwill
Development costs
Patents and licenses
Technology based intangibles
66,645
127,365
8,694
19,202
221,906
Additions
8,582
2,280
10,863
Additions through acquisition
13,839
13,105
27,066
(70)
80,484
135,999
8,695
21,482
259,765
6,115
2,920
9,035
(9,339)
Exchange differences
146
80,611
132,794
24,402
259,607
Accumulated amortisation and Impairment losses
(66,645)
(112,262)
(8,549)
(18,180)
(205,636)
(1,190)
Impairment losses (Note 5)
(1,596)
(115,048)
(208,422)
(1,381)
(1,385)
(2,128)
(16)
(2,144)
9,339
(109,226)
(18,200)
(202,620)
13,966
23,568
6,202
20,951
3,302
Included within development costs are projects with a carrying value of US$12.8 million which were not amortised in 2025 (2024: US$7.0 million) (2023: US$1.6 million). These development costs are not being amortised as the projects to which the costs relate were not fully complete at the end of the financial year. As at December 31, 2025 these projects are expected to be completed during the period from January 1, 2026 to December 31 2027, at an expected further cost of approximately US$15 million to US$25 million.
During the year ended December 31, 2025, the Group derecognised development costs that were fully amortised as of December 31, 2024. As these assets were fully amortised, the derecognition resulted in an equal reduction of the gross carrying amount and accumulated amortisation of US$9.3 million, with no impact on the Group’s net assets or profit for the year.
Borrowing costs of US$2.9 million were capitalised during the year in respect of qualifying intangible assets (2024: US$2.1 million) (see Note 6 – Financial income and expenses)
Included within technology-based intangibles in 2024 is an amount of US$13.1 million related to the recognition of acquired technology-based intangible assets from the Waveform, Metabolomics, and Epicapture acquisitions. These assets were recognised at fair value in accordance with IFRS 3. Further details of these acquisitions are provided in Note 29. As the acquired technologies were not yet available for use at year-end, no amortisation has been recorded during 2025 and 2024. Amortisation will commence when the technologies are brought into commercial use.
144
GOODWILL AND INTANGIBLE ASSETS (CONTINUED)
The following represents the costs incurred during each period presented for each of the principal development projects:
Continuous glucose monitoring testing
Metabolomic - PrePsia
Total capitalised development costs
Other intangible assets
Other intangible assets consist primarily of software assets, acquired customer and supplier lists, trade names and websites.
During the year ended December 31, 2024, additions of US$13.2 million were recorded in respect of intangible assets acquired through business combinations. These relate to the fair value of identifiable intangible assets recognised as part of the acquisitions of Waveform, EpiCapture and Metabolomics. The acquired intangible assets comprise the following:
Customer relationships
Trade names and brand assets
Proprietary technology and software
Supplier agreements
Website and digital assets
The fair values of these assets were determined as part of the purchase price allocation process in accordance with IFRS 3 Business Combinations. Refer to Note 29 for further detail on the business combinations.
During the year ended December 31, 2025, no additions were recorded in respect of intangible assets acquired through business combinations.
Amortisation is charged to the consolidated statement of operations through the selling, general and administrative expenses line.
Impairment testing for intangibles including goodwill and indefinite lived assets
Goodwill and other intangibles are subject to impairment testing on a periodic basis and whenever there are indicators of impairment. Specific assets are assessed for impairment when there are indicators of impairment. If any such indication exists, the Company estimates the recoverable amount of the asset.
The recoverable amount of nine CGUs is determined based on a value-in-use computation at June 30 and December 31. The value-in-use calculations use cash flow projections based on the 2026 and 2027 projections for each CGU and a further three years projections using estimated revenue and cost average growth rates of between 2% and 3%. At the end of the five-year forecast period, terminal values for each CGU, based on a long-term growth rate of 2%, are used in the value-in-use calculations. The value-in-use represents the present value of the future cash flows, including the terminal value, discounted at a rate appropriate to each CGU. The pre-tax discount rates used range from 15% to 21% (2024: 17% to 28%).
Sources of estimation uncertainty
145
Impairment tests of cash-generating units
The impairment tests performed at June 30, 2025 and at December 31, 2025 resulted in an impairment loss being recorded in four CGUs, Trinity Biotech Manufacturing Limited, Immco Diagnostics Inc, Primus Corp and Clark Laboratories.
The table below sets forth the impairment loss recorded for each of the CGU’s, comprising both the specific asset impairment charges recorded in year ended December 31, 2025 as per the below table and the impairments arising from the CGU impairment tests:
Immco Diagnostics Inc.
Trinity Biotech Manufacturing Limited
(120)
Trinity Biotech Do Brasil
Primus Corp
2,129
916
Clark Laboratories Inc.
Biopool US Inc.
219
2,364
The table below sets forth the breakdown of the impairment loss for each class of asset:
Goodwill and other intangible assets (see Note 12)
Property, plant and equipment (see Note 11)
220
Financial assets (see Note 13)
Management is seeking to implement profit improvement initiatives across these entities, however the values in use of these CGUs at June 30, 2025 and December 31, 2025, defined as the present value of the future projected cash flows, were below the value of the carrying amount of their assets, other than inventories, accounts receivable, cash and cash equivalents and deferred tax assets.
The value-in-use calculations for CGUs are subject to significant estimation, uncertainty and accounting judgements and the following sensitivity analysis has been performed:
Specific asset impairment charges
In the year ended December 31, 2025, certain plant items in our Bray production facility related to the production of UniGold HIV were fully impaired because of transformation activities. In line with the transfer of upstream manufacturing processes to a contract manufacturing partner by Q2 2026, certain plant and equipment related to UniGold HIV production were assessed as having limited future utility. An impairment charge of US$187,000 was recognised to reflect the revised recoverable amount. This has been included within ‘Selling, general and administrative expenses – Transformation costs. See also Note 5 and 11.
Premier Resolution is a capitalized intangible asset held within Primus Corporation and relates to the Resolution platform for haemoglobinopathy and variant testing in the US market. While the platform has achieved technical feasibility and obtained FDA clearance in late 2023, the commercialization pathway is dependent on securing adoption within a highly concentrated US reference laboratory market. While the Group continues to pursue commercial opportunities for the platform and believes that it retains underlying potential, these factors have resulted in the recoverable amount of the asset being lower than its carrying value. Accordingly, the Group recognized a partial impairment charge of US$2.1 million during the year.
In the year ended December 31, 2024, two internally developed intangible assets were fully impaired, and certain plant items in our Bray production facility and the right-of-use asset associated with the Kansas production facility were both fully impaired as a result of restructuring activities:
The T10 HPLC Analyzer project was an internally developed HPLC analyser intended for mid‑volume haemoglobin testing laboratories, with the Chinese market identified as the primary commercial opportunity. While the project achieved technical feasibility and initial market validation, developments in global trade relations, including increased uncertainty regarding market access between the United States and China, significantly reduced the expected commercial viability of the asset. The related intangible asset was fully impaired and an impairment charge of US$916,000 was recognised in the Primus Corp. entity in the year ended December 31, 2024.
The Syphilis Point of Care project is an internally developed lateral flow assay intended for the global syphilis and HIV/syphilis dual testing markets. Although the project demonstrated technical feasibility prior to 2020, the suspension of development activities during the COVID-19 pandemic and subsequent changes in manufacturing strategy introduced additional uncertainty around technical completion, regulatory approval timelines, and cost to completion. As a result of this reassessment, and in light of the need for further development work before the product can be commercialised, the Group fully impaired the project and recorded an impairment charge of US$680,000 in the year ended December 31, 2024.
Trinscreen, one of the Group’s HIV screening products, was manufactured at Trinity Biotech Manufacturing Ltd in 2024. In line with the planned transfer of Point-of-Care/HIV product manufacturing to a contract manufacturing partner by Q2 2025, certain plant and equipment at Trinity Biotech Manufacturing Limited were assessed as having limited future utility. An impairment charge of US$223,000 was recognised to reflect the revised recoverable amount and was included in within ‘Selling, general and administrative expenses – transformation costs’ (see Note 11) in the year ended December 31, 2024.
The Kansas City facility, operated by Primus Corporation, supports the manufacture and R&D of the Group’s haemoglobin product range. At year-end, the Group assessed that the associated right-of-use asset no longer has future economic benefit, and a full impairment charge of US$133,000 was recognized within ‘Selling, general and administrative expenses – transformation costs’ in the year ended December 31, 2024.
Significant Goodwill and Intangible Assets with Indefinite Useful Lives
During 2024, goodwill was recognised in connection with the acquisitions of Waveform Technologies' CGM assets, EpiCapture, and Metabolomics. The carrying value of goodwill as at December 31, 2025 was US$14.0 million. The CGUs for which goodwill is considered significant from a Group perspective, and the additional disclosures required for these CGUs, are set out below.
147
Goodwill arising from the purchase of CGM assets from Waveform Technologies
Carrying amount of goodwill (US$’000)
12,403
Discount rate applied (real pre-tax)
18.6
% EBITDA would need to decrease for an impairment to arise
56.51
Long-term growth rate
2.0
The Waveform CGM CGU includes proprietary continuous glucose monitoring (CGM) technology and related assets acquired from Waveform Technologies in January 2024. As at December 31, 2025, goodwill allocated to the CGM cash‑generating unit (“CGU”) amounted to US$12.4 million.
The Group performed an impairment assessment of goodwill as at December 31, 2025. The recoverable amount of the CGU was determined based on a value‑in‑use model, using forecast cash flows and a terminal value. The key assumptions applied in the impairment assessment were consistent with the prior year and included a pre‑tax discount rate of 16.2% and a long‑term growth rate of 2.0%.
No impairment loss was recognised in respect of the Waveform CGM CGU during the years ended December 31, 2025 and December 31, 2024. Management concluded that there were no indicators of impairment, that the recoverable amount of the CGU exceeded its carrying amount, and that no reasonably possible change in key assumptions would lead to the carrying amount exceeding the recoverable amount.
Goodwill arising from the acquisition of EpiCapture Limited
1,420
21.9
84.35
The EpiCapture CGU includes oncology diagnostics technology and associated intellectual property acquired in 2024. As at December 31, 2025, goodwill allocated to the EpiCapture CGU amounted to US$1.4 million.
The Group performed an impairment assessment of goodwill as at December 31, 2025. The recoverable amount of the CGU was determined based on a value‑in‑use model, using forecast cash flows and a terminal value. The key assumptions applied in the impairment assessment were consistent with the prior year and included a pre‑tax discount rate of 20.0% and a long‑term growth rate of 2.0%.
No impairment loss was recognised in respect of the EpiCapture CGM CGU during the years ended December 31, 2025 and December 31, 2024. Management concluded that there were no indicators of impairment, that the recoverable amount of the CGU exceeded its carrying amount, and that no reasonably possible change in key assumptions would lead to the carrying amount exceeding the recoverable amount.
Goodwill arising from the acquisition of Metabolomic Diagnostics Limited
Goodwill of US$6,000 was recognised in connection with the acquisition of Metabolomics. This amount is not considered individually material to the Group, and therefore no further disclosures have been provided in accordance with IAS 36.
Intangible Assets with Indefinite Useful lives (included in other intangibles)
The trade name assets purchased as part of the acquisition of Primus in 2005 was valued using the relief from royalty method and based on factors such as (1) the market and competitive trends and (2) the expected usage of the name. At December 31, 2025, the carrying value of this trade name asset was US$365,000 (December 31, 2024: US$365,000). Management has determined that this trade name is expected to generate net cash inflows for the Group for an indefinite period and, accordingly, they are classified as intangible assets with indefinite useful lives.
148
13.
FINANCIAL ASSETS
Additions in year
2,562
Write off in the year
Fair value remeasured through profit & loss
(107)
3,155
318
3,473
Provision for impairment
(1,500)
Reversal of impairment in the current year (Note 5)
800
During 2024, the Company purchased a strategic investment in Novus Diagnostics Limited, a company pioneering a rapid sepsis testing platform, acquiring a 12.5% stake at that time. This investment will accelerate the development and commercialization of Novus’ groundbreaking point-of-care diagnostic solutions, including its 15-minute bloodstream infection test. The investment was valued at approximately US$2,562,000 and was made through issuance of approximately 1,399,985 ADSs in the Company. The ADS issuance was recognised directly in equity. The investment does not meet the criteria for classification at amortised cost, as it is not held to collect contractual cash flows. Also, the Company did not make irrevocable election to measure it at fair value through other comprehensive income (FVOCI). Accordingly, the investment is measured at fair value through profit or loss (FVTPL) in accordance with IFRS 9.
As at December 31, 2025 and 2024, the investment is classified within Level 3 of the fair value hierarchy under IFRS 13, as it is not quoted in an active market and the fair value was determined using unobservable inputs. A remeasurement gain of US$0.3 million was recognised in profit or loss for the year ended December 31, 2025 (2024: loss of US$0.1 million). The remeasurement gain reflects the translation of the euro‑denominated investment into US dollars.
The fair value of the investment is determined by reference to observable third‑party investment information for the underlying investee, including the pricing and terms of recent arm’s length transactions with external investors, adjusted as necessary to reflect the rights and attributes of the Group’s investment. As the investment is denominated in euro, the fair value is translated into US dollars at the period‑end exchange rate.
Carrying amounts at December 31, 2025 of US$2.8 million relates solely to the Novus investment.
14.
DEFERRED TAX ASSETS AND LIABILITIES
Recognised deferred tax assets and liabilities
Deferred tax assets and liabilities of the Group are attributable to the following:
Assets
Liabilities
Net
601
Intangible assets
(4,140)
(3,001)
776
1,424
1,414
Tax value of loss carry-forwards
1,025
1,026
Other items
195
(527)
(1,560)
(332)
(1,447)
Deferred tax assets/(liabilities)
(4,667)
(4,561)
(743)
(1,008)
The deferred tax asset at December 31, 2025 is mainly due to deductible temporary differences relating to provisions and loss carry-forwards in 2025, the deferred tax asset increased by US$0.4 million mainly due to an increase in deductible temporary differences principally attributable to imputed interest provisions.
The deferred tax liability is caused by the net book value of non-current assets being greater than the tax written down value of non-current assets, temporary differences due to the acceleration of the recognition of certain charges in calculating taxable income permitted in Ireland and the US. The deferred tax liability increased by US$0.1 million in 2025, principally because of temporary differences in relation to acquired intangible assets.
Deferred tax assets and liabilities are only offset when the entity has a legally enforceable right to set off current tax assets against current tax liabilities and where the intention is to settle current tax liabilities and assets on a net basis or to realise the assets and settle the liabilities simultaneously. At December 31, 2025 and at December 31, 2024 no deferred tax assets and liabilities are offset as it is not certain as to whether there is a legally enforceable right to set off current tax assets against current tax liabilities and it is also uncertain as to what current tax assets may be set off against current tax liabilities and in what periods.
Movement in temporary differences during the year
Balance
January 1,
Recognised
in income
in discontinued operations
December 31,
377
(1,139)
(97)
1,115
265
168
(931)
(2,070)
671
558
856
1,030
(1,255)
(192)
(683)
DEFERRED TAX ASSETS AND LIABILITIES (CONTINUED)
Unrecognised deferred tax assets
Deferred tax assets have not been recognised by the Group in respect of the following items, which have not been tax effected:
Capital losses
8,293
Net operating losses
180,810
US alternative minimum tax credits
1,791
Other temporary timing differences
19,246
210,466
210,140
15.
OTHER NON-CURRENT ASSETS
16.
INVENTORIES
Raw materials and consumables
11,485
10,032
Work-in-progress
3,738
4,989
Finished goods
3,605
4,353
The assets of the Group, including inventories, have been pledged as security for the term loan from Perceptive Advisors.
All inventories are stated at the lower of cost or net realisable value. Total inventories for the Group are shown net of provisions of US$7,101,000 (2024: US$7,648,000) (2023: US$11,344,000). Cost of sales in 2025 includes inventories expensed of US$29,546,000 (2024: US$38,001,000) (2023: US$35,091,000).
The movement on the inventory provision for the three-year period to December 31, 2025 is as follows:
Opening provision at January 1
7,648
11,344
16,274
Charged during the year
Utilised during the year
(1,176)
(5,809)
(5,456)
Eliminated on disposal of business
(1,765)
Closing provision at December 31
7,101
151
17.
TRADE AND OTHER RECEIVABLES
Trade receivables, net of impairment losses
9,362
13,416
Prepayments
1,654
1,979
Contract assets
326
460
Value added tax
Other receivables
Trade receivables are shown net of an impairment losses provision of US$1.1 million (2024: US$2.3 million) (see Note 27).
Long-term contract receivable
(i) Finance lease commitments – Group as lessor
As at December 31, 2025, the Group had no finance lease arrangements as lessor (2024: Nil)
(ii) Operating lease commitments – Group as lessor
The Group leases diagnostic and analytical instruments under operating leases as part of its business.
Future minimum rentals receivable under non-cancellable operating leases are as follows:
Instruments
Less than one year
1,762
1,461
152
18.
CASH AND CASH EQUIVALENTS
Cash at bank and in hand
19.
CAPITAL AND RESERVES
During the year 2025 and 2024, the Company maintained the ADS ratio of 20:1 meaning, twenty (20) ‘A’ ordinary shares of the Company representing one (1) American Depository Share (ADS) .
Class ‘A’ Ordinary shares
‘000s
In thousands of shares
In issue at January 1
371,749
165,866
Issued for a cash consideration (a)
13,447
81,628
Issued for non-cash consideration (b)
1,566
124,255
At period end
386,762
In thousands of ADSs
Balance at January 1
18,587
Issued for a cash consideration
672
4,081
Issued for non-cash consideration
6,213
19,337
The amounts in the tables above are inclusive of Treasury Shares. The number of Treasury Shares is as follows:
Class ‘A’ Treasury shares
12,556
Purchased during period
CAPITAL AND RESERVES (CONTINUED)
628
During the year ended December 31, 2025, the Company issued 13,447,000 ‘A’ Ordinary shares for consideration of US$0.55 million settled in cash. The Company incurred expenses of US$0.04 million in connection with the issuances. No employee share options were exercised during the year.
During the year ended December 31, 2025, the Company issued 1,566,000 ‘A’ Ordinary shares (78,000 ADS) for a non-cash consideration to Chronomed, Inc. pursuant to a settlement agreement.
(c)
During the year ended December 31, 2024, the Company issued following shares for a consideration other than cash:
On January 31, 2024, the Company issued 36,000,000 ‘A’ Ordinary shares (1,800,000 ADS) as a part of the purchase consideration to acquire Waveform Technologies Inc., as a wholly owned subsidiary.
On September 24, 2024, the Company issued 5,406,000 ‘A’ Ordinary shares (270,000 ADS) as a part of the purchase consideration to acquire Metabolomic Diagnostics Limited, as a wholly owned subsidiary.
On October 10, 2024, the Company issued 13,000,000 ‘A’ Ordinary shares (650,000 ADS) to Craig-Hallum pursuant to the Advisory Agreement.
On October 10, 2024, the Company issued 7,237,000 ‘A’ Ordinary shares (362,000 ADS) to Native Design Limited pursuant to a design services agreement.
On October 25, 2024, the Company issued 34,612,000 ‘A’ Ordinary shares (1,731,000 ADS) as a purchase consideration to acquire EpiCapture Limited, as a wholly owned subsidiary.
On October 25, 2024, the Company issued 28,000,000 ‘A’ Ordinary shares (1,400,000 ADS) as a purchase consideration to acquire 12.5% equity stake in Novus Diagnostics.
The translation reserve comprises all foreign exchange differences arising from the translation of the financial statements of foreign currency denominated operations of the Group since January 1, 2004.
Other reserves comprise of:
i) The hedging reserve of US$23,000. The hedging reserve comprises the effective portion of the cumulative net change in the fair value of cash flow hedging instruments related to hedged transactions entered into but not yet crystallised. The hedging reserve is shown within Other Reserves in the Consolidated Statement of Financial Position.
ii) During 2025, the shareholders of the Company approved a reduction in the nominal value of each ‘A' Ordinary share from US$0.0109 to US$0.0001. The number of ‘A’ ordinary shares in issue remained unchanged. The reduction resulted in a transfer of US$4.3 million from equity share capital to other reserve (being non-distributable in nature). The transaction had no impact on profit or loss or cashflows.
Equity component of Convertible Note
In May 2022, the Company completed a US$45.2 million investment from MiCo IVD Holdings, LLC (“MiCo”). The investment consisted of an equity investment of US$25.2 million and a seven-year, unsecured junior convertible note of US$20.0 million. The convertible note mandatorily converts into ADSs if the volume weighted average price of the Company’s ADSs is at or above US$16.20 for any five consecutive NASDAQ trading days. The convertible loan is accounted for as a compound financial instrument containing both an equity and liability element. The equity component of the convertible note is US$6.7 million. There is no remeasurement of the equity element following initial recognition.
During 2025, the Group did not purchase any ‘A’ Ordinary shares (2024: nil) (2023: nil) ‘Treasury shares’.
154
20.
SHARE OPTIONS
Under the terms of the Company’s Employee Share Option Plans, options to purchase 40,017,505‘A’ Ordinary Shares (2,000,876 ADS’s) were outstanding at December 31, 2025. Under these Plans, options are granted to officers and employees of the Group at the discretion of the Compensation Committee (designated by the Board of Directors), under the terms outlined below.
Share options are sometimes granted to consultants of the Group and the fair value of the services provided by these consultants is measured by reference to the fair value of the equity instruments granted. This approach is adopted as it is impractical for the Group to reliably estimate the fair value of such services. There are 2,000,000 outstanding options for consultants at December 31, 2025.
The terms and conditions of the grants are as follows, whereby all options are settled by physical delivery of shares:
Vesting conditions
The options vest following a period of service by the officer or employee. The required period of service is determined by the Board or any other relevant delegated committee at the date of grant of the options (usually the date of approval by the Compensation Committee) and it is generally over a two to four-year period.
Non-vesting conditions
Since 2022, share options were granted to directors and certain employees for which there is a condition that the options only become exercisable into ADSs when the market price of an ADS reaches a certain level. This is deemed to be a non-vesting condition. The term ‘non-vesting condition’ is not explicitly defined in IFRS 2, Share based payments, but is inferred to be any condition that does not meet the definition of a vesting condition. The only condition for these particular options to vest is that the director or employee continues service and there were no other conditions which would be considered non-vesting conditions. Non-vesting conditions are reflected in measuring the grant-date fair value of the share-based payment and there is no true-up in the measurement of the share-based payment for differences between the expected and the actual outcome of non-vesting conditions. If all service conditions are met, then the share-based payment cost will be recognized even if the director or employee does not receive the share-based payment due to a failure to meet the non-vesting condition.
Contractual life
The term of an option is determined by the Board of Directors, typically through its Remuneration Committee and Employee Compensation Committee, provided that the term may not exceed ten years from the date of grant. All options will terminate 90 days after termination of the option holder’s employment, service or consultancy with the Group (or one year after such termination because of death or disability) except where a longer period is approved by the Board of Directors. Under certain circumstances involving a change in control of the Group, the Board may accelerate the exercisability and termination of options.
155
SHARE OPTIONS (CONTINUED)
The number and weighted average exercise price of share options per ordinary share is as follows:
Share Options ‘A’ Ordinary Shares
Weighted- average exercise price US$ Per ‘A’ Ordinary Share
Range US$ Per ‘A’ Ordinary Share
Outstanding January 1, 2023
44,814,672
0.47
0.19-2.43
Granted
19,600,000
0.12-0.25
Exercised
(880,000)
0.19-0.19
Expired / Forfeited
(16,620,000)
0.33
0.27-2.43
Outstanding December 31, 2023
46,914,672
0.39
0.12-1.34
Exercisable December 31, 2023
19,764,672
0.19-1.34
Outstanding January 1, 2024
12,100,000
0.14-0.14
(18,508,000)
0.50
Outstanding December 31, 2024
40,506,672
0.26
0.12-1.29
Exercisable December 31, 2024
17,275,422
0.41
Outstanding January 1, 2025
(489,167)
0.35
0.14-1.29
Outstanding December 31, 2025
0.12-1.10
Exercisable December 31, 2025
24,123,755
0.32
156
In February 2024, the Company adjusted its ADS ratio from 1 ADS: 4 ordinary shares to 1 ADS: 20 ordinary shares. The 2025 and 2024 ADS amounts in the below tables reflect this change.
The number and weighted average exercise price of share options per ADS is as follows:
Share Options ‘ADS’ Equivalent
Weighted- average exercise price US$ Per ‘ADS’
Range US$ Per ‘ADS’
2,240,734
9.40
3.80-48.60
980,000
2.40-5.00
(44,000)
3.80-3.80
(831,000)
6.60
5.40-48.60
2,345,734
7.80
2.40-26.80
988,234
3.80-26.80
605,000
2.80-2.80
(925,400)
10.00
2,025,334
5.20
2.40-25.80
863,771
8.20
(24,458)
6.99
2.80-25.80
2,000,876
2.40-22.05
1,206,188
6.39
The opening share price per ‘A’ Ordinary share at the start of the financial year was US$0.04 or US$0.89 per ADS (2024: US$0.10 per ‘A’ ordinary share or US$2.00 per ADS) (2023: US$0.24 per ‘A’ ordinary share or US$4.8 per ADS) and the closing share price at December 31, 2025 was US$0.04 per ‘A’ ordinary share or US$0.79 per ADS (2024: US$0.04 per ‘A’ ordinary share or US$0.88 per ADS) (2023: US$0.11 per ‘A’ ordinary share or US$2.15 per ADS).
157
A summary of the range of prices for the Company’s share options for the year ended December 31, 2025 follows:
Outstanding
Exercisable
Exercise price range
No. of
options
Weighted–
average
exercise
price
Weighted-average contractual
life
remaining (years)
US$0.12-US$0.99
39,897,505
3.99
24,003,755
3.38
US$1.00-US$1.29
1.10
1.96
‘ADS
equivalent’
US$2.40-US$19.80
1,994,876
1,200,188
6.56
US$20.00-US$25.80
6,000
22.05
The weighted-average remaining contractual life of options outstanding at December 31, 2025 was 3.99 years (2024: 4.98 years).
A summary of the range of prices for the Company’s share options for the year ended December 31, 2024 follows:
40,356,672
0.25
5.00
17,125,422
0.40
4.78
150,000
1.14
2.38
3.76
2.36
2,017,834
856,271
8.00
7,500
22.80
159
Charge for the year under IFRS 2
The charge for the year is calculated based on the fair value of the options granted which have not yet vested.
The fair value of the options is expensed over the vesting period of the option. In 2025, US$324,000 (2024: US$1,316,000) (2023: US$2,069,000) was charged to selling, general and administrative expenses in the statement of operations.
The fair value of services received in return for share options granted are measured by reference to the fair value of share options granted. The estimate of the fair value of services received is measured based on a Black-Scholes model. There were no share options granted in 2025. The following are the input assumptions used in determining the fair value of share options granted in 2024 and 2023.:
Key management personnel
Weighted average fair value at measurement date per ‘A’ share / (per ADS)
US$0.10 /(US$2.08)
US$0.50 /(US$10.04)
Total ‘A’ share options granted / (ADS’s equivalent)
12,100,000 / (605,000)
19,600,000 /(980,000)
Weighted average share price per ‘A’ share / (per ADS)
US$0.14/(US$2.80)
US$0.14 /(US$2.80)
Weighted average exercise price per ‘A’ share / (per ADS)
Weighted average expected volatility
74.40
40.21
Weighted average expected life
Weighted average risk-free interest rate
4.06
4.13
The expected life of the options is based on historical data and is not necessarily indicative of exercise patterns that may occur. The expected volatility is based on the historic volatility (calculated based on the expected life of the options). The Group has considered how future experience may affect historical volatility. The profile and activities of the Group are not expected to change in the immediate future and therefore Trinity Biotech would expect estimated volatility to be consistent with historical volatility.
The model assumed an expected dividend yield of 0%, consistent with the Group’s current dividend policy.
21.
TRADE AND OTHER PAYABLES
Trade payables
11,478
6,833
Accruals and other liabilities
16,932
13,597
Payroll taxes
310
659
Employee related social insurance
413
5,384
Deferred income
197
Included in trade and other payables at December 31, 2025 was US$218,000 (2024: US$185,000) relating to contracted licence payments.
Contingent consideration of US$5.0 million included in this balance at 31 December 2024 has been reclassified to accruals and other liabilities during the year following the amendment to the Perceptive term loan facility in December 2025, as the amount is no longer contingent in nature. Further details on the modification of contingent consideration arrangements are disclosed in Note 29.
22.
PROVISIONS
Product warranty provision
Legal & regulatory provision
735
Disposal-related warranty settlement provision
1,076
1,594
1,126
2,529
Current
Non-current
During 2025 and 2024 the Group experienced no significant product warranty claims. However, the Group believes that it is appropriate to retain a product warranty provision to cover any future claims. The provision at December 31, 2025 represents the estimated cost of product warranties, the exact amount which cannot be determined. US$50,000 represents management’s best estimate of these obligations at December 31, 2025.
During the year, the Group recognised a provision of US$Nil (2024: US$0.7 million) in respect of a matter relating to second‑round Paycheck Protection Program (PPP) loans received by certain U.S. subsidiaries. During 2025, this matter was settled. Of the provision recognised at 31 December 2024, approximately US$0.3 million was utilised as part of the settlement. The remaining balance was released, resulting in a credit of US$0.2 million recognised within once‑off costs and a further credit of US$0.2 million recognised within finance costs, reflecting the reversal of previously accrued interest. As the matter has now been resolved, the Directors no longer consider that the disclosure of further information would be seriously prejudicial to the Group’s position, and accordingly the exemption applied under IAS 37.92 in the prior year is no longer required.
PROVISIONS (CONTINUED)
At December 31, 2025, the Company recognised a provision of US$1.1 million (2024: US$2.5 million) in respect of transformation activities undertaken as part of the Group’s business transformation programme (refer to Note 5). The transformation provision is expected to be fully utilised during the next 12 months. No further transformation provisions are anticipated at the reporting date.
The movement on provisions is as follows:
328
2,479
(1,316)
Released during the year
(415)
23.
INTEREST-BEARING LOANS AND BORROWINGS
The carrying value of interest-bearing loans, borrowings and related balances is as follows:
Exchangeable senior notes
108,225
Non-Current liabilities
Contingent liability (Note 29)
19,650
91,263
Non-Current assets
Derivative financial asset
In January 2022, the Company retired approximately US$99.7 million of the Exchangeable Notes as part of a debt re-financing. This represented approximately 99.7% of the total Exchangeable Notes. Consideration was in cash and an issue of ‘A’ Ordinary shares. The cash paid was US$86.73 million with each holder that was party to the agreement receiving US$0.87 of cash per US$1 nominal value of the Exchangeable Notes. The shares consideration was 1,066,600 ADSs (21,332,000 ‘A’ Ordinary shares) representing the equivalent of US$0.40 of the Company’s ADS (based upon the 5-day trailing VWAP of the ADSs on NASDAQ on December 10, 2021, discounted by 13%) per US$1 nominal value of the Exchangeable Notes, as partial consideration for the exchange of the Exchangeable Notes. The shares consideration is valued at US$6.1 million based on market price on the date of issue.
INTEREST-BEARING LOANS AND BORROWINGS (CONTINUED)
Exchangeable senior notes (continued)
The Exchangeable Notes were treated as a host debt instrument under IFRS with embedded derivatives attached. The embedded derivatives related to a number of put and call options which were measured at fair value in the consolidated statement of operations. On initial recognition in 2015, the host debt instrument was recognised at the residual value of the total net proceeds of the note issue less fair value of the embedded derivatives. Subsequently, the host debt instrument was measured at amortised cost using the effective interest rate method.
The movement in the exchangeable notes balance was as follows:
(210)
Liability
The Company and its subsidiaries entered into a US$81.3 million senior secured term loan credit facility in December 2021 with Perceptive, an investment manager with an expertise in healthcare. The Term Loan was drawn down in January 2022. The Term Loan is secured by a charge over the Group’s assets. The 48-month Term Loan was originally due to expire in January 2026, however this has since been amended to a maturity date of January 2027. The loan accrued interest at an annual rate equal to 11.25% plus the greater of (a) one-month LIBOR (later changed to the Term SOFR Reference Rate effective from October 28, 2022) and (b) one percent per annum, and interest is payable monthly in arrears in cash. In connection with the initial draw down of the Term Loan the Company agreed to issue warrants to Perceptive for 500,000 of the Company’s ADSs. The per ADS exercise price of the Warrants was US$6.50.
In February 2023, the Company entered into an amended and restated senior secured Term Loan credit facility to allow for an immediate US$5 million increase to the outstanding Term Loan and provide for a US$20 million facility to fund potential acquisitions. In connection with the increased loan facility, 500,000 warrants originally issued under the Term Loan were repriced, with the Warrants having a per ADS exercise price of US$5.36 compared to their initial per ADS exercise price of US$6.50.
On April 27, 2023, the Company closed the sale of our Fitzgerald Industries life sciences supply business, the Company used approximately US$11 million of the proceeds of this sale to repay approximately US$10.1 million of its senior secured debt held by Perceptive plus an approximately US$0.9 million early repayment penalty, which has been recorded as a financial expense in the year ended December 31, 2023. In connection with this transaction, the Company entered an amendment to its senior secured Term Loan credit facility with Perceptive Advisors, which significantly reduced the Company’s minimum revenue covenants under that loan.
In January 2024, as part of the agreement to purchase the Waveform assets, we entered into an amended credit agreement with Perceptive. Under this agreement, an additional US$22 million of funding has been made available to us, with US$12.5 million being used to acquire the Waveform assets. The remaining US$9.5 million was made available for general corporate purposes including for the further development of the CGM and biosensor technologies. The Amended Term Loan also provided for additional liquidity of up to US$6.5 million for general corporate purposes which the Company drew down in April 2024.
163
In December 2024, the Company entered into a further amendment to the credit agreement with Perceptive. As part of this amendment, the Company drew down an additional US$2.0 million for general corporate purposes. We also agreed that certain interest payments payable in 2024 and 2025 would be paid-in-kind on the applicable payment date by increasing the outstanding principal amount of the Term Loan. This included the interest payments due for the period from September through December 2024, which were settled through PIK. Additionally, as part of this amendment the Company granted Perceptive new warrants to purchase an additional 1,500,000 ADSs at an exercise price of US$0.80 per ADS, and the exercise price of its existing ADS warrants was also reset to US$0.80 per ADS.
On February 27, 2025, we entered into the fourth amended and restated credit agreement, which provided for an additional US$4.0 million in term loan funding. On May 14th, 2025, we entered into a fifth amendment to the credit agreement, which provided for an additional US$2.0 million in term loan funding, extended the maturity date of the Term Loan to July 27, 2026, and provided that interest payments for the months of April, May, and June 2025 will be paid-in-kind.
On August 7, 2025, we entered into a sixth amendment to the credit agreement, which provided for a further US$2.0 million in funding, extended the maturity date of the Term Loan by a further three months to October 1, 2026, and confirmed that interest payments for the months of July and August 2025 would be paid-in-kind. Additional warrants were also provided that allow an additional 750,000 ADSs to be purchased at $0.86 per ADS.
On October 16, 2025, the Company entered into an amendment to the sixth amendment to the credit agreement, which provided for a further US$2.0 million in funding, and confirmed that interest payments for the months of September and October 2025 would be paid-in-kind.
On 22 December 2025, the Group entered a further amendment of its senior secured term loan facility with Perceptive. The terms of the amendment were assessed under IFRS 9 and determined to result in a substantial modification of the existing financial liability. Accordingly, the original term loan, with a carrying amount of US$93.3 million immediately prior to the amendment, was derecognised, together with the associated embedded derivative balances. The derecognition gave rise to a loss recognised in finance expense in the consolidated statement of operations for the year, including a loss on extinguishment of US$10.0 million representing the difference between the carrying amount of the extinguished facility and the fair value of the new facility recognised. Further, the amendment extended the maturity date of the Term Loan to January 15, 2027.
Following derecognition, the amended facility was recognised as a new financial liability at its fair value on the amendment date. The new term loan was recognised at an initial amortised cost of US$106.9 million representing the replacement of the existing facility of US$101.9 million, together with an additional US$5.0 million drawdown. In accordance with IFRS 9, embedded call option and conversion option features were separately recognised as derivative financial assets and liabilities on initial recognition. The movements in both the extinguished liability and the newly recognised loan are presented in the loan movement table below.
In connection with the December 22, 2025 amendment, we issued a senior convertible note evidencing the Term Loans outstanding under the Credit Agreement at the time. Up to US$60.0 million of the aggregate principal amount of the Convertible Note with Perceptive is convertible at the holder’s election into ADSs, at a conversion price of 97% of the VWAP of the ADSs at the time of each such conversion, subject to a floor price of US$1.03 (the “Conversion Price”) and a beneficial ownership cap. The Convertible Note restricts the conversion thereof to the extent that, upon such conversion, the number of the Company’s ordinary shares then beneficially owned by the holder and its “Attribution Parties” (as defined in the Convertible Note), including its affiliates and any other person or entities with which such holder would constitute a Section 13(d) “group,” would exceed 9.9% of the total number of ordinary shares then outstanding (the “Perceptive Beneficial Ownership Cap”). As part of the December 22, 2025 amendment, the parties also addressed two separate contingent consideration obligations arising in connection with the Waveform acquisition.
In connection with the December 22, 2025 amendment, TRIB Biosensors Inc. (“TRIB B”) Perceptive Credit Holdings II, L.P entered into a conversion rights agreement with Perceptive Credit Holdings II, L.P. (the “Conversion Rights Agreement”), pursuant to which we and Perceptive agreed to permit a US$5.0 million payment obligation of TRIB B owed to Perceptive in connection with the Waveform acquisition (the “Milestone Payment Obligation”) to be satisfied, at Perceptive’s election, by converting that obligation (in whole or in part) into our ADSs at the Conversion Price, as defined above, at the time of each such conversion. This payment obligation of US$5.0 million is included within ‘Accruals and other liabilities’ as at December 31, 2025 (US$5.0 million included in ‘Contingent consideration’ as at December 31, 2024), see Note 21.
The Conversion Rights Agreement also provided for the termination of TRIB B’s contingent payment obligation in connection with the Waveform acquisition of up to US$15.0 million in exchange for TRIB B’s agreement to pay US$7.5 million to Perceptive, and the parties’ agreement to permit that obligation to be satisfied (in whole or in part), at Perceptive’s election, by converting such obligation into ADSs at the Conversion Price at the time of each conversion. Perceptive’s ability to convert obligations under the Conversion Rights Agreement is also subject to the Perceptive Beneficial Ownership Cap. This obligation had a fair value of nil immediately prior to the amendment and was replaced with a fixed settlement amount of US$7.5 million. The US$7.5 million amount was incorporated into the revised term loan balance recognised upon derecognition of the old loan and recognition of a new loan under IFRS 9.
The movement in the Term Loan was as follows:
(72,391)
(40,109)
Drawdowns under old loan (pre‑extinguishment)
(10,000)
(30,500)
Loan drawdown costs (pre‑extinguishment)
339
325
Payment-in-kind (PIK) Interest
(3,291)
Accretion interest (Note 6)
Non-cash loan modification gain
Extinguishment of old loan (IFRS 9 derecognition)
93,323
Initial recognition of new term loan
(101,947)
Loan drawdown under new term loan
(5,000)
Derivative financial asset at date of drawdown
(28)
Balance at December 31
(108,015)
Drawdowns under old loan (pre‑extinguishment) represent additional funding advanced under the existing credit agreement prior to the amendment on December 22, 2025, including incremental funding made available through amendments to the facility during the year. As these drawdowns occurred before the amendment date, they form part of the carrying amount of the original financial liability that was derecognised.
Loan drawdown costs (pre‑extinguishment) comprise incremental transaction costs directly attributable to obtaining additional funding under the existing term loan facility. These costs were capitalised and amortised as part of the effective interest rate of the original facility until derecognition.
Payment‑in‑kind (“PIK”) interest relates to interest amounts contractually permitted to be settled by capitalising the interest and increasing the outstanding principal balance of the term loan instead of being settled in cash. These amounts increased the carrying value of the loan in accordance with IFRS 9.
Accretion interest represents the non‑cash unwinding of the discount on the term loan recognised through the effective interest rate method, reflecting the time value of money and the amortisation of transaction costs and fair value adjustments embedded in the loan.
In Q1 2024, the Company negotiated a 2.5% reduction in the interest rate on its term loan facility, lowering the rate from 11.25% to 8.75% In accordance with IFRS 9, this amendment was treated as a non‑substantial modification of the financial liability. As a result, the carrying amount of the loan was remeasured using the original effective interest rate (EIR), and a non‑cash gain of US$3.6 million was recognised in finance income. This gain reflects the difference between the previous carrying amount of the loan and the present value of the modified contractual cash flows, discounted at the original EIR, and is presented in the consolidated statement of operations as a “Non‑cash loan modification gain.” The reduced base interest rate of 8.75% remained in effect throughout 2025. During the year, further non‑substantial amendments were executed, primarily relating to extensions of the loan maturity date. These amendments altered the timing of contractual cash flows and, when remeasured in accordance with IFRS 9 using the original EIR, resulted in an additional non‑cash loan modification gain of US$1.7 million recognised in finance income.
Extinguishment of old loan (IFRS 9 derecognition) reflects the derecognition of the original term loan, with a carrying amount of US$93.3 million immediately prior to the amendment on December 22, 2025, following the conclusion that the amended terms represented a substantial modification under IFRS 9.
Covenant compliance and waivers under the senior secured term loan
Subsequent to December 31, 2025, the Company received a waiver from Perceptive in respect of a compliance breach of the minimum revenue covenant for the twelve‑month period ended December 31, 2025. The covenant breach primarily reflected timing‑related variability in HIV revenues, including the timing of the scale‑up of the Group’s outsourced and offshored manufacturing model. These factors affected the timing of shipments and revenue recognition between reporting periods, rather than indicating a deterioration in underlying demand. Although this waiver was granted subsequent to the reporting date, the Company was not in compliance with this covenant as at December 31, 2025.
In addition, subsequent to year‑end the Company obtained waivers of the minimum revenue covenant applicable to quarterly measurement periods through July 1, 2026. The Company also received waivers in respect of the minimum liquidity covenant for the measurement periods ended March 31, 2026 and April 30, 2026. The scheduled increase in the minimum liquidity threshold was also deferred until July 1, 2026. Each of these waivers and the liquidity covenant deferral relates to covenant measurement periods occurring after December 31, 2025.
165
Notwithstanding the waivers obtained subsequent to the reporting period, the senior secured term loan is classified as a current liability in the consolidated statement of financial position as at December 31, 2025. In accordance with IAS 1.69(d) and IAS 1.74, when a covenant breach exists at the reporting date and a waiver is obtained only after that date, the entity does not have an unconditional right to defer settlement of the liability for at least twelve months as at the reporting date.
The waivers described above do not amend the contractual maturity of the Company’s senior secured term loan, which remains January 15, 2027.
Post - balance sheet amendment to senior secured term loan and Convertible Note agreement
Derivative financial asset and financial liability
The movement in the derivative financial asset in the year was as follows:
178
Fair value adjustments in the period (old derivative)
(166)
(40)
Initial recognition of new derivative asset (call option)
Non-current asset at December 31
As part of the amendment to the senior secured term loan on December 22, 2025, the Group identified a new embedded call option that meets the definition of a derivative under IFRS 9. In line with the derecognition of the original term loan on the amendment date, the embedded derivatives associated with the previous facility were also derecognised. A new call option embedded in the amended loan was recognised at fair value on initial recognition and is subsequently measured at fair value through profit or loss. The carrying value of this derivative financial asset at December 31, 2025 was US$0.25 million (2024: US$0.2 million).
The movement in the derivative financial liability in the year was as follows:
(1,658)
(526)
Derivative financial liability at date of drawdown
(1,066)
Fair value adjustments in the period
Recognition of new derivative liabilities (conversion options)
(1,483)
Non-current liability at December 31
(3,320)
Under the amended loan arrangements, the Group identified embedded conversion features that are not closely related to the economic characteristics and risks of the host instruments. Accordingly, these features were separated from their host contracts and recognised as derivative financial liabilities at fair value on initial recognition. During the year, new embedded conversion options with a fair value of US$1.5 million were recognised. The Group’s total derivative financial liabilities, including previously recognised instruments and fair value movements, amounted to US$3.3 million at December 31, 2025 (2024: US$1.7 million).
All derivative financial instruments are remeasured at each reporting date, with gains or losses arising from changes in fair value recognised in finance income or finance expense in the consolidated statement of operations.
7-year convertible note
In connection with MiCo’s investment in 2022, we issued MiCo a seven-year, unsecured junior convertible note of US$20.0 million, The convertible note has an interest rate of 1.5% and interest is payable quarterly. The convertible note mandatorily converts into ADSs if the volume weighted average price of our ADSs is at or above US$16.20 for any five consecutive NASDAQ trading days. Based on public filings, we understand that on December 2, 2025, MiCo was acquired by AI n M net Limited because of a share purchase agreement with Dayli Trinity Holdings Limited.
The convertible loan note is accounted for as a compound financial instrument containing both an equity and liability element. The debt component is accounted for at amortised cost in accordance with IFRS 9. At December 31, 2025, the carrying value of the convertible note’s debt component was US$16.3 million (2024: US$15.4 million) and accretion interest of US$0.9 million (2024: US$0.9 million) has been recognised as a financial expense in the year. The equity component of the convertible note is US$6.7 million and has been recorded in the equity section of the statement of financial position as Equity component of convertible note. There is no remeasurement of the equity element following initial recognition.
The movement in the 7-year convertible note in the year was as follows:
(15,401)
(14,542)
Accretion interest
(16,330)
167
24.
LEASE LIABILITIES
The Group has leases for some of its manufacturing plants, all warehouses, offices, motor vehicles and some IT equipment. With the exception of short-term leases and leases of low-value underlying assets, each lease is reflected on the balance sheet as a right-of-use asset (net of any depreciation and/or impairment) and a lease liability. Variable lease payments which do not depend on an index or a rate (such as lease payments based on a percentage of Group sales) are excluded from the initial measurement of the lease liability and asset. The Group classifies its right-of-use assets in a consistent manner to its property, plant and equipment (see Note 11).
Each lease generally imposes a restriction that, unless there is a contractual right for the Group to sublet the asset to another party, the right-of-use asset can only be used by the Group. Leases are either non-cancellable or may only be cancelled by incurring a substantive termination fee. Some leases contain an option to purchase the underlying leased asset outright at the end of the lease, or to extend the lease for a further term. The Group is prohibited from selling or pledging the underlying leased assets as security. For leases over office buildings and factory premises the Group must keep those properties in a good state of repair and return the properties in their original condition at the end of the lease. Further, the Group must insure items of property, plant and equipment and incur maintenance fees on such items in accordance with the lease contracts.
Lease liabilities are payable as follows:
Lease liabilities related to Right of Use assets
Lease liabilities related to
Right of Use assets
Minimum lease payments
Interest
Principal
In more than one year, but not more than two
3,000
2,515
In more than two years but not more than five
6,110
845
5,265
More than five years
3,318
3,060
15,643
2,215
13,428
LEASE LIABILITIES (CONTINUED)
2,862
577
2,214
472
1,742
5,487
955
4,532
4,652
4,203
15,215
2,453
12,762
Lease payments not recognised as a liability
No short-term lease expenses were incurred for the year ended December 31, 2025. Payments made under such leases are expensed on a straight-line basis. In addition, certain variable lease payments are not permitted to be recognised as lease liabilities and are expensed as incurred.
The total paid in respect of lease liabilities in the year ended December 31, 2025, was US$3,187,000 (2024: US$2,503,000).
25.
COMMITMENTS AND CONTINGENCIES
Capital Commitments
The Group has capital commitments authorised and contracted for of US$ nil as at December 31, 2025 (2024: US$ nil).
Leasing Commitments
The Group’s leasing commitments are shown in Note 24.
169
COMMITMENTS AND CONTINGENCIES (CONTINUED)
Bank Security
The Credit Agreement for the senior secured term loan is secured by substantially all of our property and assets, including our equity interests in our subsidiaries, refer to Note 23.
(d)
Group Company Guarantees
Pursuant to the provisions of Section 357, Companies Act, 2014, the Company has guaranteed the liabilities of Trinity Biotech Manufacturing Limited, Trinity Research Limited, Konamite Limited, Metabolomic Diagnostics Limited, EpiCapture Limited and Trinity Biotech Financial Services Limited subsidiary undertakings in the Republic of Ireland, for the financial year to December 31, 2025 and, as a result, these subsidiary undertakings have been exempted from the filing provisions of Section 357, Companies Act, 2014. Where the Company enters into these guarantees of the indebtedness of other companies within its Group, the Company considers these to be insurance arrangements and accounts for them as such. The Company treats the guarantee contract as a contingent liability until such time as it becomes probable that the Company will be required to make a payment under the guarantee. The Company does not enter into financial guarantees with third parties.
(e)
Government Grant Contingencies
The Group has received training and employment grant income from Irish development agencies. Subject to existence of certain conditions specified in the grant agreements, this income may become repayable. No such conditions existed as at December 31, 2025. However, if the income were to become repayable, the maximum amounts repayable as at December 31, 2025 would amount to US$3,557,000 (2024: US$3,313,000).
(f)
Contingent considerations relating to business combinations
As part of the acquisition of the CGM assets of Waveform Technologies, Inc., the Company agreed to contingent consideration of up to US$20.0 million based on share price, trading volume and commercial milestones. In December 2025, as part of the amendment to the Perceptive term loan facility, this contingent consideration arrangement was contractually modified.
A US$5.0 million trading‑based component became an unconditional obligation of the Group and is therefore no longer contingent in nature and is recognised within accruals and other liabilities as at December 31, 2025. The remaining US$15.0 million was extinguished as contingent consideration and incorporated into the amended Perceptive term loan facility as part of the amendment to the loan in December 2025.
Accordingly, there was no contingent consideration relating to the Waveform acquisition outstanding as at December 31, 2025. Refer to Note 29 for further details.
As part of the acquisition of EpiCapture Limited (see Note 29), contingent consideration of up to US$0.5 million may become payable based on cumulative revenue targets. The fair value of this contingent consideration is US$0.4 million as of December 31, 2025. Refer to Note 29 for further details.
(g)
Other Contingencies
The Company has other contingencies primarily relating to claims and legal proceedings, onerous contracts, product warranties and employee related provisions. The status of each significant claim and legal proceeding in which the Company is involved is reviewed by management on a periodic basis and the Group’s potential financial exposure is assessed. If the potential loss from any claim or legal proceeding is considered probable, and the amount can be reliably estimated, a liability is recognised for the estimated loss. Because of the uncertainties inherent in such matters, the related provisions are based on the best information available at the time; the issues taken into account by management and factored into the assessment of legal contingencies include, as applicable, the status of settlement negotiations, interpretations of contractual obligations, prior experience with similar contingencies/claims, and advice obtained from legal counsel and other third parties. The Group expects the majority of these provisions will be utilised within one to three years of the balance sheet date; however due to the nature of the legal provisions there is a level of uncertainty in the timing of settlement as the Group generally cannot determine the extent and duration of the legal process.
170
26.
RELATED PARTY TRANSACTIONS
The Group has related party relationships with its subsidiaries, and with its directors and executive officers.
Leasing arrangements with related parties
The Group has entered into various arrangements with JRJ Investments (“JRJ”), a partnership owned by Mr Ronan O’Caoimh, a director of the Company, and a former director, Dr Jim Walsh who resigned in September 2025, as well as directly with Mr O’Caoimh, to provide premises in Bray, Ireland.
The Group entered into an agreement with JRJ for a 25-year lease commencing in December 2003 for offices that were adjacent to its then premises at IDA Business Park, Bray, County Wicklow, Ireland with an annual rent of €381,000 (US$429,000). Upward-only rent reviews are carried out every five years and there have been no increases arising from these rent reviews.
In 2007 we entered into a 25-year lease agreement with JRJ for a 43,860 square foot manufacturing facility in Bray, Ireland with an annual rent of €787,000 (US$887,000). Subsequent to the signing of this lease, the ownership of the building transferred from JRJ to Mr O’Caoimh solely. A rent review for this property became effective 1 July 2022 and, following an independent valuation, the annual rent increased to €1,050,000 (US$1,183,000), with backdated rent accruing from that date. Included within overhead costs in cost of sales in 2024 is an amount of $659,000 in respect of backdated rent. In 2016, we entered into a 10-year lease with Mr. O’Caoimh for a warehouse adjacent to our leased manufacturing facility in Bray, Ireland. The warehouse is 16,000 square feet with an annual rent of €144,000 (US$162,000). A rent review for this property became effective on 1 July 2021 and, following an independent valuation, the annual rent increased to €170,560, with backdated rent accruing from that date. Included within overhead costs in cost of sales is an amount of $97,000 in respect of backdated rent. Independent valuers advised the Group that the rent in respect of each of the leases represented a fair market rent.
In late 2020, the Group occupied some additional space adjoining the warehouse owned by Mr O’Caoimh. This was a short-term arrangement, and no payments were made for the additional space during 2020 and 2021. The Company vacated this space in 2021. In 2022, the rent payable to Mr O’Caoimh of US$90,000 was settled.
At the time that the arrangements were entered into, Trinity Biotech and its directors (excepting Mr O’Caoimh and Dr Walsh (a director of the Company at that time before his retirement in September 2025) who expressed no opinion on this point) believed they represented a fair and reasonable basis on which the Group could meet its ongoing requirements for premises. Dr Walsh has no ownership interest in the additional space adjoining the warehouse owned by Mr O’Caoimh and was therefore entitled to express an opinion on this arrangement.
In September 2024, the Company completed the acquisition of Metabolomics Diagnostics Ltd ("Metabolomics") for consideration of approximately US$0.9 million, satisfied through the issuance of approximately 0.27 million ADSs and the extinguishment of amounts owed to the Company totaling US$0.41 million. At the time of the acquisition, Dr. Jim Walsh, then a director of the Company, held a 6% minority shareholding in Metabolomics. Based on the net assets acquired and goodwill recognised, the value attributable to Dr. Walsh’s interest was estimated at approximately $55,000. Dr. Walsh fully disclosed his interest, and the acquisition was approved unanimously by the board, with appropriate procedures followed to manage the potential conflict of interest, including the passing of a resolution under the Company's Constitution to authorise Dr. Walsh’s involvement in the decision-making process. The transaction was conducted at arm’s length, and the board determined that it was in the best interests of the Company.
RELATED PARTY TRANSACTIONS (CONTINUED)
Compensation of key management personnel of the Group
During the year ended December 31, 2025, the Group’s key management personnel comprised directors Mr. Ronan O’Caoimh, and Mr. John Gillard and Dr. Jim Walsh. Dr Jim Walsh resigned in September 2025. (2024: Mr. Ronan O’Caoimh, and Mr. John Gillard and Dr. Jim Walsh) The Group does not engage a separate management entity, as all key management personnel are employed directly by the Group. Compensation for the year for these personnel is detailed below:
Short-term employee benefits
768
Performance related bonus
440
Post-employment benefits
Share-based compensation benefits as calculated under IFRS 2
1,396
2,253
The amounts disclosed in respect of directors’ emoluments in Note 9 includes independent directors’ fees and non-executive director fees of US$118,000 (2024: US$114,000) and share-based compensation benefits of US$58,000 (2024: US$213,000). Total directors’ remuneration is also included in “employment” (Note 3) and “(Loss)/profit before tax” (Note 9).
At 31 December 2025, an amount accrued of US$984,000 (2024: US$658,000) in respect of bonus compensation related to the Chief Executive Officer remained unpaid. The balance reflects a voluntary deferral agreed by the Chief Executive Officer. The balance is unsecured and bears no interest.
Directors’ interests in the Company’s shares and share option plan
‘A’ Ordinary Shares
Share options
11,317,777
32,993,336
Shares purchased during the year
Expired / forfeited
(379,167)
32,614,169
11,117,777
30,387,336
200,000
5,600,000
(2,994,000)
172
27.
CAPITAL AND FINANCIAL RISK MANAGEMENT
Capital Management
The Group’s policy is to maintain a strong capital base to maintain investor, creditor and market confidence and to sustain future development of the business. The Board of Directors monitors (loss)/earnings per share as a measure of performance, which the Group defines as (loss)/profit after tax divided by the weighted average number of shares in issue.
Fair Values
The table below sets out the Group’s classification of each class of financial assets/liabilities, their fair values and under which valuation method they are valued:
Level 1
Level 2
Level 3
Total carrying amount
Fair Value
Note
Loans and receivables at amortised cost
Trade receivables
14,500
Liabilities at amortised cost
Exchangeable note
(13,428)
Trade and other payables (excluding deferred income)
(29,516)
(1,126)
(44,070)
(124,555)
(168,625)
Fair value through profit and loss (FVPL)
Derivative liability - warrants
Derivative asset – prepayment option
Equity investments in Novus
(298)
(29,321)
(127,875)
(154,423)
Level 3: valuation techniques for which the lowest level of inputs that have a significant effect on the recorded fair value are not based on observable market data.
173
CAPITAL AND FINANCIAL RISK MANAGEMENT (CONTINUED)
18,583
(12,762)
(26,585)
(2,529)
(41,876)
(88,002)
(129,878)
(1,492)
963
(23,293)
(89,494)
(110,332)
The valuation techniques used for instruments categorised as level 2 are described below:
The fair values of the options associated with the exchangeable notes are calculated in consultation with third-party valuation specialists due to the complexity of their nature. There are a number of inputs utilised in the valuation of the options, including share price, historical share price volatility, risk-free rate and the expected borrowing cost spread over the risk-free rate.
Financial Risk Management
The Group uses a range of financial instruments (including cash, finance leases, receivables, payables and derivatives) to fund its operations. These instruments are used to manage the liquidity of the Group. Working capital management is a key additional element in the effective management of overall liquidity. The Group does not trade in financial instruments or derivatives. The main risks arising from the utilization of these financial instruments are interest rate risk, liquidity risk and credit risk.
Interest rate risk
As of December 31, 2025, all of the Group’s financial instruments referencing interest rates are based on SOFR, a post-reform benchmark rate. The Group no longer has exposure to interest rate benchmarks subject to IBOR reform; therefore, the disclosure requirements related to benchmark interest rate reform are not applicable.
Effective and repricing analysis
The following tables sets out all interest-earning financial assets and interest-bearing financial liabilities held by the Group at December 31, 2025 and 2024, indicating their effective interest rates and the period in which they re-price:
Effective
interest rate
6 mths or less
6 –12 mths
1-2 years
2-5 years
> 5 years
Exchangeable note1
4.0
Senior secured term loan2
12.8
Convertible note3
1.5
Lease payable on Right of Use assets
5 to 14.8
(1,331)
(1,257)
(2,515)
(5,265)
(3,060)
(132,845)
(104,208)
(21,595)
(3,270)
16.3
5.0
(1,150)
(1,135)
(4,532)
(4,203)
(95,597)
4,017
(74,133)
(19,933)
(4,413)
1 The maturity of the exchangeable notes is based on the contractual maturity date of April 1, 2045.
2 The senior secured term loan is a variable instrument. In January 2024, the amended term loan agreement reduced the annual rate of interest on the loan by 2.5% to 8.75% plus the greater of (a) Term Secured Overnight Financing Rate or (b) 4.0% per annum, and allows for a further 2.5% reduction in the base rate to 6.25% once the outstanding principal under the term loan falls below US$35 million. On 22 December 2025, the Group entered a further amendment of its senior secured term loan facility with Perceptive. The terms of the amendment were assessed under IFRS 9 and determined to result in a substantial modification of the existing financial liability. The loan has a contractual maturity in January 2027 under the new modified loan terms.
3 The 7-year convertible note was issued in May 2022 and is a fixed rate instrument which bears a fixed rate of interest of 1.5% per annum.
In broad terms, a one-percentage point increase in interest rates would increase interest income by US$Nil (2024: US$Nil) as at December 31, 2025 the Company holds no funds in interest-bearing accounts; while the annual impact on the interest expense would be an increase of US$1,080,000 (2024: US$724,000) on the costs of servicing the senior secured term loan.
Interest rate profile of financial assets / liabilities
The interest rate profile of financial assets/liabilities of the Group was as follows:
Variable rate instruments
Variable rate financial liabilities (senior secured term loan)
(102,877)
(67,224)
Fixed rate instruments
Fixed rate financial liabilities (exchangeable note)
Fixed rate financial liabilities (convertible note)
Fixed rate financial liabilities (lease payables)
(29,968)
(28,373)
Fair value sensitivity analysis for fixed rate instruments
The Group does not account for any fixed rate financial liabilities at fair value through profit and loss. Therefore, a change in interest rates at December 31, 2025 or December 31, 2024 would not affect profit or loss. There was no significant difference between the fair value and carrying value of the Group’s trade receivables and trade and other payables at December 31, 2025 and December 31, 2024 as all fell due within 6 months.
Liquidity risk
The following are the contractual maturities of financial liabilities, including estimated interest payments:
Carrying amount
Contractual cash flows
6 mths –12 mths
>5 years
Financial liabilities
29,516
1,661
1,554
Senior secured term loan¹
117,854
4,725
113,129
21,025
300
20,425
Exchangeable notes
372
332
167,499
184,410
36,056
114,837
3,308
26,559
3,650
¹ The contractual cash flows of interest on the senior secured term loan is estimated based on the prevailing interest rate at December 31, 2025
176
26,585
15,214
2,213
81,438
1,703
3,319
76,416
21,350
900
19,850
340
127,349
144,967
29,896
4,881
78,937
6,411
24,842
¹ The contractual cash flows of interest on the senior secured term loan is estimated based on the prevailing interest rate at December 31, 2024.
Foreign exchange risk
The majority of the Group’s activities are conducted in US Dollars. Foreign exchange risk arises from the fluctuating value of the Group’s Euro denominated expenses as a result of the movement in the exchange rate between the US Dollar and the Euro. There were no forward contracts in place as at December 31, 2025 or December 31, 2024.
Foreign currency financial assets and liabilities which expose the Group to currency risk are disclosed below. The amounts shown are those reported to key management translated into US Dollars at the closing rate:
EUR
GBP
SEK
CAD
BRL
657
253
Trade and other receivable
490
901
(13,669)
(277)
(34)
(129)
(8,504)
(299)
Total exposure
(21,026)
(233)
(18)
726
293
373
1,009
294
1,019
(7,098)
(453)
(12)
(114)
(135)
(6,867)
(171)
(12,840)
(329)
1,086
177
Sensitivity analysis
A 10% strengthening of the US Dollar against the Euro at December 31, 2025 would have increased profit and other equity by the amounts shown below. This analysis assumes that all other variables, in particular interest rates, remain constant.
Profit or Loss
Euro
1,911
1,167
A 10% weakening of the US Dollar against the Euro at December 31, 2025 would have decreased profit and other equity by the amounts shown below. This analysis assumes that all other variables, in particular interest rates, remain constant.
(2,336)
(1,427)
The sensitivity analysis is based on the Group’s foreign currency exposures at the reporting date and assumes a 10% movement in the US Dollar against the Euro. The analysis includes monetary assets and liabilities denominated in Euro at the reporting date and assumes that exchange rate changes occur at the period-end and are applied to the net exposure. Non-monetary items and future forecast transactions are excluded. The analysis assumes that all other variables, including interest rates, remain constant. The analysis does not incorporate interdependencies between variables, such as interest rate effects on exchange rates, and is not based on a value-at-risk model.
The objective of this analysis is to assess the potential impact of reasonably possible changes in exchange rates on the Group’s profit or loss and equity, based on exposures at the reporting date. The analysis reflects only monetary assets and liabilities denominated in foreign currencies and does not include future transactions or embedded derivatives. The analysis has inherent limitations, as it is based on a hypothetical movement in a single variable (foreign exchange rate) and assumes all other variables remain constant. It does not consider the potential interdependence between risk factors (such as changes in interest rates or inflation), nor does it reflect management’s dynamic hedging activities or the potential impact on fair value from market volatility occurring after the reporting date.
Credit Risk
The Group has no significant concentrations of credit risk. Exposure to credit risk is monitored on an ongoing basis. For trade receivables, the Group applies the simplified approach to measuring expected credit losses and recognizes a lifetime expected credit loss allowance. A receivable is considered credit-impaired when it is more than 120 days past due or when there is evidence of significant financial difficulty. The Group maintains specific provisions for potential credit losses. To date such losses have been within management’s expectations. Due to the large number of customers and the geographical dispersion of these customers, the Group has no significant concentrations of accounts receivable.
With respect to credit risk arising from the other financial assets of the Group, which comprise cash and cash equivalents, the Group’s exposure to credit risk arises from default of the counterparty, with a maximum exposure equal to the carrying amount of these instruments. The Group’s management considers that all of the above financial assets that are not impaired or past due for each of the 31 December reporting dates under review are of good credit quality.
The Group maintains cash and cash equivalents with various financial institutions. The Group performs regular and detailed evaluations of these financial institutions to assess their relative credit standing. The carrying amount reported in the balance sheet for cash and cash equivalents approximate their fair value.
Exposure to credit risk
The carrying amount of financial assets represents the maximum credit exposure. The maximum exposure to credit risk is as follows:
Carrying Value
Third party trade receivables (Note 17)
Cash and cash equivalents (Note 18)
The maximum exposure to credit risk for trade receivables and finance lease income receivable by geographic location is as follows:
2,667
4,185
Euro-zone countries
409
742
211
741
Other regions
6,075
7,748
The maximum exposure to credit risk for trade receivables and finance lease income receivable by type of customer is as follows:
End-user customers
2,598
3,828
Distributors
6,412
8,236
Non-governmental organisations
352
1,352
Due to the large number of customers and the geographical dispersion of these customers, the Group has no significant concentrations of accounts receivable.
179
Impairment Losses
The ageing of trade receivables at December 31, 2025 is as follows:
Gross
Expected Credit Loss Rate
Not past due
7,718
9,363
Past due 0-30 days
3.4
1,455
Past due 31-120 days
504
3.3
1,753
1.8
Greater than 120 days
1,741
59.2
3,131
2,255
72.0
10,448
1,085
15,702
2,286
The Group considers that the credit risk of a financial asset may have increased since initial recognition when it is more than 30 days past due, unless there is evidence to the contrary. As at December 31, 2025, all trade receivables past due more than 30 days were assessed for changes in credit risk since initial recognition. Based on this assessment:
Receivables past due between 31 and 120 days are not automatically considered to have an increased credit risk unless other qualitative indicators are present (e.g., known financial difficulty, adverse changes in circumstances, etc.).
Receivables past due more than 120 days are generally considered to have a higher credit risk and are assessed for lifetime expected credit losses.
The Group applies a simplified approach in measuring expected credit losses which uses a provision matrix based on historical credit loss experience, adjusted for forward-looking factors specific to the debtors and the economic environment.
The movement in the allowance for impairment in respect of trade receivables during the year was as follows:
2,324
(Reversed)/charged to costs and expenses
(324)
225
Amounts written off during the year
(876)
(263)
The allowance for impairment in respect of trade receivables is used to record impairment losses unless the Group is satisfied that no recovery of the account owing is possible. At this point the amount is considered irrecoverable and is written off against the financial asset directly.
The Group does not provide financing to customers as a main business activity and therefore is not required to present credit risk exposure disclosures by credit risk grade.
180
28.
RECONCILIATION OF LIABILITIES ARISING FROM FINANCING ACTIVITIES
The changes in the Group’s liabilities arising from financing activities can be classified as follows:
Borrowings & derivative financial instruments
23,24
91,474
Cash-flows:
Loan drawdown under old term loan
10,000
Loan origination costs paid
(339)
Interest paid for convertible note
Interest paid for exchangeable notes
Repayment of leases
Non-cash:
Interest charged
308
Conversion options on the date of new loan
1,625
Additions (related to Right of Use assets)
2,110
Exchange adjustment
1,099
3,575
644
Fair value of derivative liability - warrants
(285)
Fair value of additional derivative liability - warrants
464
Fair value of conversion - warrants
(142)
Interest capitalised on outstanding loans and balances
11,456
Fair value movement on contingent liability
(1,871)
(1,706)
Extinguishment of old term loan
(93,323)
Recognition of new term loan
101,947
127,875
181
RECONCILIATION OF LIABILITIES ARISING FROM FINANCING ACTIVITIES (CONTINUED)
55,387
12,566
Principal amount loaned – term loan
30,500
Interest paid for senior secured term loan
(6,253)
6,561
Derivative financial asset at date of issue
855
(512)
3,214
592
1,066
3,291
Contingent liability
(3,567)
182
29.
BUSINESS COMBINATIONS
Acquisition of the CGM assets of Waveform Technologies, Inc.
On January 30, 2024, the Company purchased the biosensor and continuous glucose monitoring (“CGM”) assets of privately held Waveform Technologies, Inc. (“Waveform”) for the initial consideration of US$12.5 million in cash and 36 million ‘A’ Ordinary shares (represented by 1.8 million ADSs) of the Company, which had a fair value of US$3,960,000 on the date of acquisition. In addition contingent consideration of up to a maximum of US$20 million formed part of the total consideration. We intend to update the Waveform CGM device, which is not being marketed, and optimize it for broad adoption and then evolve this platform technology to measure and analyze other valuable biomarkers and related datapoints. Our vision is to develop a portfolio of technologies that can offer users and clinicians valuable actionable health and wellness insights. Control was obtained through the acquisition of substantially all of Waveform’s operational assets and intellectual property, representing an integrated set of activities and assets capable of being conducted and managed to provide a return in the form of outputs. The integrated set of activities and assets purchased will significantly contribute to achieving our vision and its associated outputs.
This transaction was accounted for as a business combination under IFRS 3 based on the acquisition of an integrated set of activities and assets, including intellectual property, technical processes, and a skilled workforce, that together constitute a business capable of being conducted and managed to provide returns
The fair value of non-cash consideration in the form of ADSs issued in connection with the acquisition was determined using the volume-weighted average price (VWAP) of the Company’s ADSs on the acquisition date.
Contingent consideration of up to US$20 million was contractually payable upon the occurrence of certain events, including;
•
US$5.0 million payment if, within the next 12 months after acquisition date, (i) the closing price of the Company’s ADSs does not exceed US$7.50 per ADS for at a least 20 consecutive trading days and (ii) the average daily trading volume of the Company’s ADSs does not equal or exceed 20,000 ADSs for 20 consecutive trading days, and
An amount equal to 50% of the proceeds received by the Company (up to a maximum payment of additional consideration of US$15.0 million) on our entering into certain commercial partnering agreements with certain glucose pump manufacturers within 24 months of the acquisition date. At the acquisition date, the fair value assigned to this element of the contingent consideration was US$1.8 million which was disclosed as a contingent liability in Note 23.
The fair value of the contingent consideration at date of acquisition was US$6.8 million. Of this, US$5.0 million was classified as a current liability (Note 21), while US$1.8 million was recognised as a contingent consideration liability under IFRS 3 and subsequently remeasured at fair value. During 2025, the contingent consideration relating to potential partnering arrangements was incorporated into the amended Perceptive term loan facility as part of the modification and extinguishment of the prior debt instrument. At the date of modification, management assessed the fair value of this contingent consideration as being nil, and the liability was derecognised, resulting in the recognition of a fair value gain of $1.8 million in profit or loss (Note 4).
Acquisition-related costs amounting to US$1.5 million in respect of the Waveform transaction were not included as part of consideration transferred and have been recognised as an expense in the condensed consolidated statement of operations, within ‘Selling, general and administrative expenses’ in the year ended December 31, 2024.
The initial assignment of fair values to identifiable net assets acquired was performed on a provisional basis in respect of the above acquisitions. Any amendments to these acquisition fair values within the 12-month timeframe from the date of acquisition will be disclosed in the relevant Annual Report as stipulated by IFRS 3 Business Combinations.
Provisional value
Measurement period adjustment
Adjusted values
1,569
(206)
1,363
Intangible assets – arising on acquisition
9,360
1,296
(1,296)
(50)
(1,170)
1,170
Net assets acquired
11,149
10,817
12,071
Consideration
23,220
Satisfied by:
Cash consideration
12,500
Non-cash consideration
3,960
Deferred contingent consideration
6,760
Total consideration
Net cash outflow – arising on acquisition
Net cash outflow
183
BUSINESS COMBINATIONS (CONTINUED)
In accordance with IFRS 3 Business Combinations, the Group finalised the fair value assessments relating to the acquisition of the Waveform CGM assets and reassessed the fair value of several acquired balances based on new information obtained during the measurement period.
The fair value of intellectual property related to the acquired technology at the Closing Date was derived using the multi-period excess earnings method. Significant assumptions used in the valuation including CGM cash flow projections which were based on estimates used to price the Waveform acquisition, and the discount rate applied was benchmarked with reference to the implied rate of return to the Company’s pricing model and the weighted-average cost of capital. The intangible asset for acquired technology will be amortized over the respective estimated periods for which the intangible assets will provide economic benefit to the Company, which is 15 years.
Following further evaluation, the deferred tax liability of US$1.2 million initially recognised on acquisition was reversed. This adjustment was based on a more detailed analysis of the tax base of the acquired intangible assets, which concluded that a deferred tax liability was not required.
In addition, the fair value of inventory was reduced by US$1.3 million. This reduction reflects a revised assessment of net realisable value. Although initial discussions with management and potential buyers such as Bayer India suggested a potential market in emerging economies, further exploration indicated that the additional expenditure required to bring the acquired raw materials, finished goods and work-in-progress to market would render the inventory commercially unviable. As a result, the inventory was deemed to have no recoverable value.
The value of property, plant and equipment was also reduced by US$0.2 million. These assets were found to be specific to the legacy CGM product and, following further technical review, were determined to have no future economic value. Accordingly, their fair value was adjusted to nil.
These adjustments were accounted for retrospectively as measurement period adjustments in accordance with IFRS 3. These measurement period adjustments resulted in a corresponding increase in goodwill of US$0.3 million.
The goodwill recognised from the acquisition of the Waveform CGM assets primarily reflects expected synergies from integrating Waveform’s European-approved CGM technology with Trinity Biotech’s global manufacturing and diabetes expertise. The platform is expected to accelerate the development of a next-generation, affordable, and user-friendly CGM device, and supports the Group’s strategy to expand into adjacent biosensor markets. None of the goodwill is expected to be deductible for tax purposes.
Waveform was acquired on January 30, 2024. As of December 31, 2025, the acquiree had not generated any revenue since the acquisition date, and therefore no revenue has been included in the Group’s consolidated statement of comprehensive income for the reporting period. In addition, the acquired business incurred a net loss of US$10 thousand, which has been included in the Group’s consolidated results. The reported loss excludes interest on intercompany funding arrangements in order to reflect the underlying performance of the acquired business. Waveform Technologies, Inc. was a privately held company in the late stages of product development and commercial readiness. Although the company was not generating revenue, it had developed a CE-marked CGM device. It did not maintain financial information in accordance with IFRS, and as such, the Group is unable to reliably reconstruct the required historical information for pro forma disclosure without incurring undue cost or effort.
Acquisition of Metabolomics Diagnostics Limited
In September 2024, the Company completed the acquisition of 100% of Metabolomics Diagnostics Ltd (“Metabolomics”), a privately-owned Irish deep-tech company, specializing in the development of novel biomarker-based diagnostic solutions for complex diseases, with the initial focus being screening for preeclampsia risk using the company’s PrePsia test. Control was obtained through the execution of a share purchase agreement, resulting in the acquisition of 100% of the voting interests. The primary reason for the acquisition was to enter a new area of medical diagnostics with significant long-term growth potential. The acquisition aligns with the Group’s strategy of combining its established capabilities with innovative technologies to unlock new revenue opportunities. The Group intends to leverage this platform to commercialise the PrePsia test in the U.S. through its Immco laboratory and to explore opportunities in international markets.
The Company acquired Metabolomics for consideration of approximately US$0.9 million paid through the issuance of approximately 0.27 million ADSs of the Company alongside the extinguishment of monies owed to the Company totalling US$0.4 million. The fair value of non-cash consideration in the form of ADSs issued in connection with the acquisition was determined using the volume-weighted average price (VWAP) of the Company’s ADSs on the acquisition date.
184
Metabolomics Provisional value
1,200
(494)
Cash acquired
906
412
Less: Cash and cash equivalents
404
Transaction costs associated with the acquisition of Metabolomics amounted to US$0.3 million, relating to the disbursement of agreed fees and closing bonuses. These costs were expensed as incurred in accordance with IFRS 3 and have been recognised in the condensed consolidated statement of operations, within ‘Selling, general and administrative expenses’ in the year ended December 31, 2024.
The goodwill recognised in respect of the Metabolomics acquisition is attributable to expected synergies arising from the combination of operations, as well as the assembled workforce of the acquired business. None of the goodwill recognised is expected to be deductible for tax purposes.
There were no measurement‑period adjustments or other changes during the year ended December 31, 2025 in respect of the acquisition accounting for Metabolomics Diagnostics Limited.
Acquisition of EpiCapture Limited
In October 2024, the Company completed the acquisition of 100% of EpiCapture Limited (“EpiCapture”), a company developing a non-invasive test for monitoring the risk of aggressive prostate cancer. Control was obtained through the execution of a share purchase agreement, resulting in the acquisition of 100% of the voting interests. The primary reason for the acquisition was to strengthen the Group’s oncology diagnostics pipeline by acquiring a novel, epigenetics-based prostate cancer test aligned with our strategy of combining Trinity’s established capabilities with cutting-edge technologies to address large-scale, urgent, and important clinical issues.
The Company acquired EpiCapture for an initial consideration of approximately US$3.0 million, with an additional consideration of US$0.5 million contingent (Note 21) on the achievement of future milestones. The initial consideration was paid through the issuance of approximately 1.7 million ADS in Trinity Biotech. The fair value of non-cash consideration in the form of Company ADSs issued in connection with the acquisition was determined using the volume-weighted average price (VWAP) of the Company’s ADSs on the acquisition date.
EpiCapture Provisional value
2,668
(406)
(333)
1,929
3,349
2,965
384
The contingent consideration related to the acquisition of EpiCapture Limited comprises deferred consideration with a fair value of US$0.4 million. An amount of US$0.5 million will become payable if cumulative revenues from EpiCapture’s operations reach US$1.0 million within a period of three years, commencing from the date on which the Company obtains validation of the EpiCapture prostate test under the New York State Department of Health’s Clinical Laboratory Evaluation Programme. As of December 31, 2025, there have been no changes to the amount recognized or to the assumptions used in its initial measurement.
Transaction costs associated with the acquisition of EpiCapture amounted to US$26,000, were expensed as incurred in accordance with IFRS 3 and have been recognised in the condensed consolidated statement of profit or loss, within ‘Selling, general and administrative expenses’ in the year ended December 31, 2024.
The goodwill recognised in respect of the EpiCapture acquisition is attributable to expected synergies arising from the combination of operations. None of the goodwill recognised is expected to be deductible for tax purposes.
EpiCapture was acquired in October 2024. As of December 31, 2025, the acquiree had not generated any revenue since the acquisition date, and therefore no revenue has been included in the Group’s consolidated statement of comprehensive income for the reporting period. The acquired business incurred a net loss of US$160,000 (before group recharges), mainly comprising legal expenses, which has been included in the Group’s consolidated results. EpiCapture Limited was a privately held, early-stage Irish company developing a novel epigenetics-based diagnostic test. As the entity did not prepare its financial information in accordance with IFRS, it is not practicable for the Group to reconstruct the required historical financial information to present pro forma consolidated results for the year ended December 31, 2025, without undue cost or effort
There were no measurement‑period adjustments or other changes during the year ended December 31, 2025 in respect of the acquisition accounting for EpiCapture Limited.
30.
POST BALANCE SHEET EVENTS
Covenant Compliance and Waivers under the Credit Agreement
Subsequent to December 31, 2025, the Company received a waiver from Perceptive in respect of compliance with the minimum revenue covenant for the twelve‑month period ended December 31, 2025. The covenant breach primarily reflected timing‑related variability in HIV revenues, including the timing of the scale‑up of the Group’s outsourced and offshored manufacturing model. These factors affected the timing of shipments and revenue recognition between reporting periods, rather than indicating a deterioration in underlying demand. Although this waiver was granted subsequent to the reporting date, the Company was not in compliance with this covenant as at December 31, 2025.
In addition, subsequent to year‑end the Company obtained waivers in respect of the minimum revenue covenant applicable to quarterly measurement periods through July 1, 2026. The Company also received waivers in respect of the minimum liquidity covenant for the measurement periods ended March 31, 2026 and April 30, 2026. The scheduled increase in the minimum liquidity threshold was also deferred until July 1, 2026. Each of these waivers and the liquidity covenant deferral relates to covenant measurement periods occurring after December 31, 2025.
Amendment to senior secured term loan and convertible note agreement
Progress on Comprehensive Transformation Plan
During Quarter 1, 2026 the Company completed the transition of upstream manufacturing processes for its UniGold HIV rapid test to its outsourced and offshore manufacturing model. Outsourced production commenced in April 2026 and the Company is currently progressing through the initial scale‑up phase of manufacturing. This marked the completion of the UniGold manufacturing transition under the Comprehensive Transformation Plan and forms part of the broader programme to improve the underlying cost structure and profitability profile of the business.
This transition to outsourcing will temporarily introduce a degree of quarter-on-quarter revenue variability in 2026. This had an impact on the Company’s revenues for the three month period ended March 31, 2026 which are expected to be in the range of approximately US$10 million to US$11 million. The extent of the progression of the scale‑up is expected to result in increased variability of HIV revenues between the second and third quarters of 2026, with a corresponding impact on profitability and cashflow.
The Company continues to progress other elements of the Comprehensive Transformation Plan, with a particular focus on the optimisation of its commercial operations in order to capitalise on the significant operational changes delivered under the plan. As part of these ongoing activities, the Company continued to review its operational footprint and organisational structure to further enhance operational efficiency and align its cost base with its strategic priorities.
These actions included continued evaluation of the scale and composition of the Company’s operations and workforce as the business is further reoriented toward biosensor and reference laboratory testing activities. While the Company may continue to implement targeted initiatives in these areas, any future actions are expected to be of a lower scale and reduced complexity relative to the transformation activities undertaken as part of the Comprehensive Transformation Plan.
Nasdaq Listing Compliance
On February 11, 2026 and February 19, 2026, the Company received deficiency notices from the Listing Qualifications Department of Nasdaq indicating that the Company was not in compliance with (i) the minimum market value of publicly held shares (“MVPHS”) requirement applicable to companies listed on the Nasdaq Global Select Market and (ii) the minimum bid price requirement of US$1.00 per ADS.
In accordance with Nasdaq Listing Rules, the Company has a 180‑day compliance period, expiring in August 2026, to regain compliance with each of these requirements. During this period, the Company’s ADSs will continue to trade on the Nasdaq Global Select Market. The Company is currently focused on taking actions intended to regain compliance with the applicable listing requirements within the prescribed compliance period.
POST BALANCE SHEET EVENTS (CONTINUED)
Capital Structure and Funding
The Company continues to evaluate various financing and capital structure options expected to be available to assist in meeting its obligations, to the extent such obligations cannot be met from cash on hand. These considerations include the refinancing of existing debt, the repayment of debt using the proceeds from potential equity or debt offerings, and the sale of assets. The Company has continued to engage with corporate finance advisors, investment banks and potential investors to assess options to optimise its capital structure. This ongoing review also includes consideration of the effectiveness of the equitisation mechanisms within the Company’s existing financing arrangements with Perceptive.
Since the commencement of the SEPA, the Company has raised approximately US$0.85 million in gross proceeds through the issuance of ADSs under the arrangement.
188
31.
ACCOUNTING ESTIMATES AND JUDGEMENTS
The preparation of these financial statements requires the Group to make estimates and judgements that affect the reported amount of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities.
On an on-going basis, the Group evaluates these estimates, including those related to intangible assets, contingencies and litigation. The estimates are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgements about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Key sources of estimation uncertainty
Note 12 contains information about the assumptions and the risk factors relating to the impairment of goodwill, other intangible assets, property, plant and equipment and financial asset. Note 20 outlines information regarding the valuation of share options. Note 23 outlines the valuation techniques used by the Company in determining the fair value of the Group’s interest-bearing loans and borrowings. In Note 27, detailed analysis is given about the interest rate risk, credit risk, liquidity risk and foreign exchange risk of the Group.
Critical accounting judgements in applying the Group’s accounting policies
Certain critical accounting judgements in applying the Group’s accounting policies are described below:
No revenue is recognised if there is uncertainty regarding recovery of the consideration due at the outset of the transaction. We make a judgement as to the collectability of invoiced sales based on an assessment of the individual debtor taking into account past payment history, the probability of default or delinquency in payments and the probability that debtor will enter into financial difficulties or bankruptcy.
Some customer contracts could be regarded as offering the customer a right of return. Due to the uncertainty of the magnitude and likelihood of product returns, there is a level of estimation involved in assessing the amount of revenue to be recognized for these types of contracts. In accordance with IFRS 15, when estimating the effect of an uncertainty on an amount of variable consideration to which the Group will be entitled, all information that is reasonably available, including historical, current and forecast, is considered.
We operate a licenced reference laboratory in New York, USA that specializes in diagnostics for autoimmune diseases. The laboratory provides testing services to two types of customers. Firstly, institutional customers, such as hospitals and commercial diagnostic testing providers, and secondly insurance companies on behalf of their policyholders. The revenue recognition for services provided to insurance companies requires some judgement. In the US, billing practices and regulatory requirements generally require insurance companies to be billed the same amount per test. However, the amount that each insurance company pays for a particular test varies according to their own internal policies and this can typically be considerably less than the amount invoiced. We recognise lab services revenue for insurance companies by taking the invoiced amount and reducing it by an estimated percentage based on historical payment data. We review the percentage reduction annually based on the latest data. As a practical expedient, and in accordance with IFRS, we apply a portfolio approach to the insurance companies as they have similar characteristics. We judge that the effect on the financial statements of using a portfolio approach for the insurance companies will not differ materially from applying IFRS 15 to the individual contracts within that portfolio.
At December 31, 2025 US$nil (2024: US$nil) (2023: US$50,000) of revenue was deferred in accordance with IFRS15.
189
ACCOUNTING ESTIMATES AND JUDGEMENTS (CONTINUED)
Research and development expenditure – capitalized development costs
Under IFRS as issued by IASB, the Group writes off research and development expenditure as incurred, with the exception of expenditure on projects whose outcome has been assessed with reasonable certainty as to technical feasibility, commercial viability and recovery of costs through future revenues. Such expenditure is capitalised at cost within intangible assets and amortised over its expected useful life of 15 years, which commences when commercial production starts. For further information, refer to Note 12.
Acquired in-process research and development (IPR&D) is valued at its fair value at acquisition date in accordance with IFRS 3. The Company determines this fair value by adopting the income approach valuation technique. Once the fair value has been determined, the Company will recognise the IPR&D as an intangible asset when it: (a) meets the definition of an asset and (b) is identifiable (i.e., is separable or arises from contractual or other legal rights).
Factors which impact our judgement to capitalise certain research and development expenditure include the degree of regulatory approval for products and the results of any market research to determine the likely future commercial success of products being developed. We review these factors each year to determine whether our previous estimates as to feasibility, viability and recovery should be changed.
At December 31, 2025 the carrying value of capitalised development costs was US$23,568,000 (2024: US$20,951,000) (see Note 12 to the consolidated financial statements). The increase in 2025 was mainly because of additions of US$6,115,000
Definite lived intangible assets are reviewed for indicators of impairment periodically while goodwill and indefinite lived assets are tested for impairment at least annually, individually or at the cash-generating unit level.
Factors considered important, as part of an impairment review, include the following:
Significant underperformance relative to expected historical or projected future operating results;
When we determine that the carrying value of intangibles and non-current assets may not be recoverable based upon the existence of one or more of the above indicators of impairment, any impairment is measured based on our estimates of projected net discounted cash flows expected to result from that asset, including eventual disposition. Our estimated impairment could prove insufficient if our analysis overestimated the cash flows or conditions change in the future.
The impairment testing performed during the year ended December 31, 2025 resulted in impairment losses being recorded totalling US$2.1 million. For further information, refer to Note 12.
We evaluate the realisability of our inventory on a case-by-case basis and make adjustments to our inventory provision based on our estimates of expected losses. We write off inventory that is approaching its “use-by” date and for which no further re-processing can be performed. We also consider recent trends in revenues for various inventory items and instances where the realisable value of inventory is likely to be less than its carrying value. Given the allowance is calculated on the basis of the actual inventory on hand at the particular balance sheet date, there were no material changes in estimates made during 2025, 2024 or 2023 which would have an impact on the carrying values of inventory during those periods, except as discussed below. At December 31, 2025 our allowance for slow moving and obsolete inventory was US$7.1 million which represents approximately 27.4% of gross inventory value. At December 31, 2024 our allowance for slow moving and obsolete inventory was US$7.6 million which represented approximately 28.3% of gross inventory value and at December 31, 2023 the provision was US$11.3 million, or approximately 36.3% of gross inventory value. The estimated allowance for slow moving and obsolete inventory as a percentage of gross inventory has decreased between 2024 and 2025 due to the physical scrapping of obsolete inventory.
Allowance for slow-moving and obsolete inventory (continued)
Management is satisfied that the assumptions made with respect to future sales and production levels of these products are reasonable to ensure the adequacy of this provision. In the event that the estimate of the provision required for slow moving and obsolete inventory was to increase or decrease by 2% of gross inventory, which would represent a reasonably likely range of outcomes, then a change in allowance of US$0.5 million at December 31, 2025 (2024: US$0.5 million) (2023: US$0.6 million) would result. For further information, refer to Note 16.
Business Combinations
The Group did not complete any business combinations during the year. The Group completed three business combinations during 2024: the acquisitions of Waveform Technologies, Metabolomics Health, and EpiCapture. Significant judgement was required in determining whether each transaction met the definition of a business under IFRS 3 Business Combinations, based on the acquisition of an integrated set of activities and assets capable of generating outputs.
In accounting for these transactions, management was required to make key estimates in the determination of the fair value of the identifiable assets acquired and liabilities assumed, including the recognition and measurement of separately identifiable intangible assets and contingent consideration. The valuations involved the use of discounted cash flow models and required management to estimate future cash flows, apply appropriate discount rates reflecting the Group’s weighted average cost of capital, and assess the probability of meeting contingent consideration milestones. The Group engaged an independent third-party valuation specialist to assist with the purchase price allocation for all three acquisitions. These estimates had a material impact on the allocation of consideration between identifiable intangible assets and goodwill.
Investment in Novus Diagnostics
During 2024, the Group acquired a minority equity interest in a privately held company that is not quoted in an active market. The investment is classified as a financial asset at fair value through profit or loss (FVTPL) in accordance with IFRS 9. The fair value of the investment was initially based on the transaction price. As the investment is classified within Level 3 of the fair value hierarchy under IFRS 13, subsequent remeasurement requires the use of unobservable inputs and significant management judgement. This includes consideration of investee-specific developments, commercial progress, and market conditions.
Management’s assessment of the Group’s ability to continue as a going concern involves significant judgement. For details of the assumptions and considerations underpinning this assessment, refer to the “Going concern” section of Note 1, which outlines the basis of preparation.
191
32.
GROUP UNDERTAKINGS
The consolidated financial statements include the financial statements of Trinity Biotech plc and the following principal subsidiary undertakings:
Name and registered office
Principal activity
Principal Country ofincorporation andoperation
Group % holding
Manufacture and saleof diagnostic test kits
100%
IDA Business Park, Bray County Wicklow, Ireland
Trinity Research Limited
Trinity Biotech Manufacturing Services Limited
Dormant
Trinity Biotech Luxembourg Sarl
Investment and provision of financial services
Luxembourg
1, rue Bender, L-1229 Luxembourg
Trinity Biotech Inc
Holding Company
U.S.A.
Girts Road, Jamestown, NY 14702, USA
Clark Laboratories Inc
Manufacture and sale of diagnostic test kits
Trading as Trinity Biotech (USA) Girts Road, Jamestown NY14702, USA
Mardx Diagnostics Inc
5919 Farnsworth Court Carlsbad CA 92008, USA
Biopool US Inc (trading as Trinity Biotech Distribution)
Sale of diagnostic test kits
Girts Road, Jamestown NY14702, USA
Primus Corporation
Manufacture and sale of diagnostic test kits and instrumentation
4231 E 75th Terrace Kansas City, MO 64132, USA
192
GROUP UNDERTAKINGS (CONTINUED)
Principal Country of incorporation and operation
Phoenix Bio-tech Corp.
Canada
1166 South Service Road West Oakville, ON L6L 5T7 Canada.
Fiomi Diagnostics Holding AB
Discontinued operation (in liquidation)
Sweden
Dag Hammarskjöldsv 52A SE-752 37 Uppsala Sweden
Fiomi Diagnostics AB
Comercio e Importacao Ltda Rua Silva Bueno 1.660 – Cj. 101/102 Ipiranga Sao Paulo Brazil
Trinity Biotech (UK) Ltd
Sales & marketing activities
UK
Mills and Reeve LLP Botanic House 100 Hills Road Cambridge, CB2 1PH United Kingdom
Immco Diagnostics Inc
Manufacture and sale of autoimmune products and laboratory services
60 Pineview Drive Buffalo NY 14228, USA
Nova Century Scientific Inc
Manufacture and sale of autoimmune products and infectious diseases
5022 South Service Road Burlington Ontario Canada
Trinity Biotech Investment Ltd
Cayman Islands
PO Box 309 Ugland House Grand Cayman KY1-1104 Cayman Islands
193
Trib Biosensors Inc.
Manufacturing, development, and sale of biosensors
USA
27700 S.W. 95th Avenue, Wilsonville, Oregon 97070, USA
Konamite Limited
Trinity Biotech Joint Venture Limited
EpiCapture Limited
19 Mather Road, Mount Merrion, Dublin, Ireland
Metabolomics Diagnostics Limited
Hoffman Park, Inchera, Little Island, Co. Cork, Ireland
Waveform Technologies Inc.
Slovenia
Obrtna cesta 18, 8310 Sentjernej, Slovenia
33.
AUTHORISATION FOR ISSUE
These Group consolidated financial statements were authorised for issue by the Board of Directors on April 30, 2026.
194
Signatures
The Registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorised the undersigned to sign this Annual Report on its behalf.
TRINITY BIOTECH PLC
By
/s/ John Gillard
Mr John Gillard
Director/
Chief Executive Officer
Date: April 30, 2026
By:
/s/ Paul Murphy
Exhibit No.
Description of Exhibit
Amended Constitution of Trinity Biotech plc (included as Exhibit 99.1 to our Report on Form 6-K filed with the Commission on October 23, 2025 and incorporated herein by reference).
Form of Deposit Agreement dated as of October 21, 1992, as amended and restated, among Trinity Biotech plc, The Bank of New York as Depositary, and all Owners and holders from time to time of American Depositary Receipts issued thereunder (included as Exhibit 1 to our Form F-6 filed on January 15, 2004 and incorporated herein by reference).
2.1
Description of Rights of Securities Registered under Section 12 of the Securities and Exchange Act of 1934 (included as Exhibit 2.1 to our Annual Report on Form 20-F filed on May 16, 2023 and incorporated herein by reference)
4.1
Trinity Biotech plc Share Option Plan 2020 (included as Exhibit 4.4 to our Registration Statement on Form S-8, filed on February 12, 2021 and incorporated herein by reference).
Trinity Biotech plc Employee Share Option Plan 2017 (included as Exhibits 4.3 to our Registration Statement on Form S-8, filed on February 12, 2021 and incorporated herein by reference).
4.3
Trinity Biotech plc Employee Share Option Plan 2013 (included as Exhibit 4.1 to our Registration Statement on Form S-8 filed on April 11, 2014 and incorporated herein by reference).
4.4
Trinity Biotech plc Employee Share Option Plan 2011 (included as Exhibit 4 to our Registration Statement on Form S-8 filed on June 22, 2012 and incorporated herein by reference).
4.5
Lease agreement dated as of October 18, 2004 between Ronan O’Caoimh and Jim Walsh with Trinity Biotech Manufacturing Limited in respect of office premises in Bray, County Wicklow, Ireland (included as Exhibit 4b.1 to our Annual Report on Form 20-F filed on March 31, 2006 and incorporated herein by reference).
4.6
Lease agreement dated as of November 26, 2004 between Ronan O’Caoimh, Jonathon O’Connell and Jim Walsh with Trinity Biotech plc in respect of warehouse premises in Bray, County Wicklow, Ireland (included as Exhibit 4b.2 to our Annual Report on Form 20-F filed March 31 2006 and incorporated herein by reference).
4.7
Lease agreement dated as of December 20, 2007 between Ronan O’Caoimh and Jim Walsh with Trinity Biotech Manufacturing Limited in respect of warehouse premises in Bray, County Wicklow, Ireland (included as Exhibit 4.13 to our Annual Report on Form 20-F filed on March 25, 2015 and incorporated herein by reference).
4.8
CDC Non-Exclusive Patent Licence Agreement dated as of May 22, 2012 (included as Exhibit 4.19 to our Annual Report on Form 20-F filed on March 25, 2015 and incorporated herein by reference).
4.9
Inverness Medical Innovations, Inc. Patent Licence Agreement renewal dated as of August 3, 2006 (included as Exhibit 4.21 to our Annual Report on Form 20-F filed on March 25, 2015 and incorporated herein by reference).
4.10
National Institute of Health Non-Exclusive Patent Licence Agreement dated as of December 17, 1999 (included as Exhibit 4.22 to our Report on Form 6-K filed on March 25, 2015 and incorporated herein by reference).
4.11
Warrant to purchase American Depositary Shares of Trinity Biotech plc, dated January 27, 2022 (included as Exhibit 4.11 to our Annual Report on Form 20-F filed on April 30, 2024 and incorporated herein by reference).
4.11.1
First Amendment to Warrant Certificate to purchase American Depositary Shares of Trinity Biotech plc dated February 21, 2023 (included as Exhibit 4.12.1 to our Report on Form 6-K filed on February 22, 2023 and incorporated herein by reference).
4.11.2
Second Amendment to Warrant to purchase American Depositary Shares of Trinity Biotech plc dated January 30, 2024 (included as Exhibit 4.13 to our Annual Report on Form 20-F filed on May 16, 2025 and incorporated herein by reference).
4.11.3
Third Amendment to Warrant to purchase American Depositary Shares of Trinity Biotech plc dated December 23, 2024 (included as Exhibit 4.14 to our Annual Report on Form 20-F filed on May 16, 2025 and incorporated herein by reference).
4.12
Securities Purchase Agreement between Trinity Biotech Plc and MiCo IVD Holdings, LLC dated April 11, 2022 (included as Exhibit 99.2 to our Report on Form 6-K filed on April 11, 2022 and incorporated herein by reference).
Convertible Loan Note (included as Exhibit 99.3 to our Report on Form 6-K filed on April 11, 2022 and incorporated herein by reference).
4.14
Investor Subordination Agreement dated May 3, 2022 (included as Exhibit 4.15 to our Annual Report on Form 20-F filed on April 30, 2024 and incorporated herein by reference).
4.15*
Share Purchase Agreement in respect of Benen Trading Limited and Fitzgerald Industries International Inc., dated as of April 20, 2023 (included as Exhibit 4.15 to our Report on Form 6-K filed on April 24, 2023 and incorporated herein by reference).
4.16 †
Transition Agreement, dated as of December 20, 2023, among Bayer Healthcare LLC, Waveform Technologies, Inc. and TRIB Biosensors Inc. (included as Exhibit 4.17 to our Annual Report on Form 20-F filed on April 30, 2024 and incorporated herein by reference).
4.17*†
Asset and Share Purchase Agreement dated as of January 30, 2024 (included as Exhibit 4.20 to our Report on Form 6-K filed on February 1, 2024 and incorporated herein by reference).
4.18.1*
Sixth Amended and Restated Credit Agreement and Guaranty, dated as of August 7, 2025 (included as Exhibit 99.2 to our Report on Form 6-K filed on August 12, 2025 and incorporated herein by reference).
4.18.2*
First Amendment to Credit Agreement, dated as of October 16, 2025, by and among Trinity Biotech, Inc., Clark Laboratories, Inc., Biopool U.S., Inc., Primus Corporation, Mardx Diagnostics, Inc. and Immco Diagnostics, Inc. as borrowers, Trinity Biotech PLC and certain of its subsidiaries as guarantors and Perceptive Credit Holdings III, LP, as Administrative Agent (included as Exhibit 99.2 to our Report on Form 6-K filed on October 23, 2025 and incorporated herein by reference).
4.18.3*
Second Amendment to Credit Agreement, dated as of December 22, 2025, by and among Trinity Biotech, Inc., Clark Laboratories, Inc., Biopool U.S., Inc., Primus Corporation, Mardx Diagnostics, Inc. and Immco Diagnostics, Inc. as borrowers, Trinity Biotech PLC and certain of its Subsidiaries as guarantors and Perceptive Credit Holdings III, LP, as Administrative Agent (included as Exhibit 99.1 to our Report on Form 6-K filed on December 23, 2025 and incorporated herein by reference).
4.18.4
Limited Waiver And Third Amendment To Sixth Amended And Restated Credit Agreement And Guaranty, dated as of April 30, 2026, by and among Trinity Biotech, Inc., Clark Laboratories, Inc., Biopool U.S., Inc., Primus Corporation, Mardx Diagnostics, Inc. and Immco Diagnostics, Inc. Trinity Biotech PLC and certain of its Subsidiaries as guarantors and Perceptive Credit Holdings III, LP.
4.19
Amended and Restated Senior Convertible Note, dated as of April 30, 2026, by and among Trinity Biotech PLC, certain of its subsidiaries and Perceptive Credit Holdings III, LP.
4.20.1
Conversion Rights Agreement, dated as of December 22, 2025, by and among Trinity Biotech PLC, TRIB Biosensors Inc. and Perceptive Credit Holdings II, L.P (included as Exhibit 99.3 to our Report on Form 6-K filed on December 23, 2025 and incorporated herein by reference).
4.20.2
Amendment No. 1 to Conversion Rights Agreement, dated as of April 30, 2026, among Trinity Biotech PLC, TRIB Biosensors Inc. and Perceptive Credit Holdings II, L.P.
4.21
Registration Rights Agreement, dated as of December 22, 2025, by and among Trinity Biotech PLC, Perceptive Credit Holdings III, L.P. and Perceptive Credit Holdings II, L.P (included as Exhibit 99.4 to our Report on Form 6-K filed on December 23, 2025 and incorporated herein by reference).
4.22.1
Warrant to purchase American Depositary Shares of Trinity Biotech plc, dated January 30, 2024 (included as Exhibit 4.20 to our Annual Report on Form 20-F filed on April 30, 2024 and incorporated herein by reference).
4.22.2
First Amendment to Warrant to purchase American Depositary Shares of Trinity Biotech plc dated December 23, 2024 (included as Exhibit 4.23 to our Annual Report on Form 20-F filed on May 16, 2025 and incorporated herein by reference).
4.22.3
Warrant to purchase to purchase American Depositary Shares of Trinity Biotech plc, dated December 23, 2024 (of Perceptive Credit Holdings III, LP) (included as Exhibit 4.24 to our Annual Report on Form 20-F filed on May 16, 2025 and incorporated herein by reference).
4.22.4
Warrant to purchase to purchase American Depositary Shares of Trinity Biotech plc, dated December 23, 2024 (of Perceptive Credit Holdings II, LP) (included as Exhibit 4.25 to our Annual Report on Form 20-F filed on May 16, 2025 and incorporated herein by reference).
4.23
Warrant to purchase American Depositary Shares of Trinity Biotech plc, dated August 7, 2025 (included as Exhibit 99.3 to our Report on Form 6-K filed on August 12, 2025 and incorporated herein by reference).
4.24*
Standby Equity Purchase Agreement between the Company and the Investor, dated February 24, 2026 (included as Exhibit 99.1 to our Report on Form 6-K filed on February 25, 2026 and incorporated herein by reference).
8.1
List of significant subsidiaries of Trinity Biotech plc (included as Item 18, note 32 to the consolidated financial statements in this Annual Report).
Insider trading policy (included as Exhibit 4.21 to our Annual Report on Form 20-F filed on April 30, 2024 and incorporated herein by reference).
12.1
Certification by Chief Executive Officer Pursuant to Section 302 of the Sarbanes- Oxley Act of 2002.
12.2
Certification by Chief Financial Officer Pursuant to Section 302 of the Sarbanes- Oxley Act of 2002.
13.1
Certification by Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
13.2
Certification by Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
15.1
Consent of Independent Registered Public Accounting Firm.
97.1
Clawback Policy.
101.INS
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 Document.
101.PRE
Inline XBRL Taxonomy Presentation Linkbase Document.
101.CAL
Inline XBRL Taxonomy Calculation Linkbase Document.
101.LAB
Inline XBRL Taxonomy Label Linkbase Document.
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document.
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
* Certain schedules to this exhibit have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Registrant hereby agrees to furnish a copy of any omitted schedules to the Commission upon request.
† Portions of this exhibit have been redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K.
198