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Watchlist
Account
Organon
OGN
#3914
Rank
NZ$6.05 B
Marketcap
๐บ๐ธ
United States
Country
NZ$23.08
Share price
-0.15%
Change (1 day)
63.25%
Change (1 year)
๐ Pharmaceuticals
๐งฌ Biotech
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Annual Reports (10-K)
Organon
Quarterly Reports (10-Q)
Financial Year FY2026 Q2
Organon - 10-Q quarterly report FY2026 Q2
Text size:
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Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________
Form
10-Q
________________
(Mark One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended
June 30, 2026
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ______ to ______
Commission File No.
001-40235
Organon & Co.
(Exact name of registrant as specified in its charter)
Delaware
46-4838035
(State or other jurisdiction of incorporation)
(I.R.S. Employer Identification No.)
30 Hudson Street, Floor 33
Jersey City,
New Jersey
07302
(Address of principal executive offices) (zip code)
(Registrant’s telephone number, including area code)
(551)
430-6900
Not Applicable
(Former name, former address and former fiscal year, if changed since last report.)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock ($0.01 par value)
OGN
New York Stock Exchange
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).
Yes
☒
No
☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
☒
Accelerated filer
☐
Non-accelerated filer
☐
Smaller reporting company
☐
Emerging growth company
☐
If an emerging growth company, 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 is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
☐
No
☒
The number of shares of common stock outstanding as of the close of business on July 24, 2026:
262,609,433
Table of Contents
Page No.
PART I
FINANCIAL INFORMATION
3
Item 1.
Financial Statements (unaudited)
3
Condensed Consolidated Statements of Income
3
Condensed Consolidated Statements of Comprehensive Income
4
Condensed Consolidated Balance Sheets
5
Condensed Consolidated Statements of Stockholders’ Equity
6
Condensed Consolidated Statements of Cash Flows
7
Notes to Condensed Consolidated Financial Statements (unaudited)
8
1.
Background and Nature of Operations
8
2.
Basis of Presentation
8
3.
Acquisitions and Licensing Arrangements
9
4.
Earnings per Share
11
5.
Product and Geographic Information
12
6.
Stock Based Compensation Plans
13
7.
Restructuring
14
8.
Taxes on Income
15
9.
Inventories
15
10.
Long-Term Debt and Short-Term Borrowings
16
11.
Financial Instruments
17
12.
Accumulated Other Comprehensive Income (Loss)
20
13.
Samsung Collaboration
20
14.
Third-Party Arrangements
21
15.
Contingencies
22
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
26
Item 3.
Quantitative and Qualitative Disclosures about Market Risk
37
Item 4.
Controls and Procedures
37
PART II
OTHER INFORMATION
39
Item 1.
Legal Proceedings
39
Item 1A.
Risk Factors
39
Item 5.
Other Information
39
Item 6.
Exhibits
40
Signatures
The following notations in this Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 (this “Form 10-Q”) have the meanings as set forth below:
“1”
Indicates, in this Form 10-Q, brand names of products, that are not available in the United States.
“2”
Indicates, in this Form 10-Q, brand names of products that are trademarks not owned by Organon & Co. or its subsidiaries.
Humira
is a trademark registered in the United States in the name of AbbVie Biotechnology Ltd.;
Enbrel
is a trademark registered in the United States in the name of Immunex Corporation;
Remicade
is a trademark registered in the United States in the name of Janssen Biotech, Inc.;
Herceptin
and
Perjeta
are trademarks registered in the United States in the name of Genentech, Inc.;
Emgality
is a trademark registered in the United States in the name of Eli Lilly and Company (used under license);
Prolia
and
Xgeva
are trademarks registered in the U.S. in the name of Amgen Inc.;
Jada
is a trademark registered in the US in the name of Alydia Health, Inc.; and
Pyzchiva
and
Epyztek
are trademarks registered in the United States, Canada and Australia in the name of Samsung Bioepis Co., Ltd. (used under license). Brand names of products that are in all italicized letters, without the footnote, are trademarks of, or are otherwise licensed by, Organon & Co. and/or one of its subsidiaries.
-2-
Table of Contents
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
Organon & Co.
Condensed Consolidated Statements of Income
(Unaudited, $ in millions except shares in thousands and per share amounts)
Three Months Ended
June 30,
Six Months Ended
June 30,
2026
2025
2026
2025
Revenues
$
1,558
$
1,594
$
3,018
$
3,107
Cost of sales
711
720
1,388
1,392
Gross profit
847
874
1,630
1,715
Selling, general and administrative
434
453
858
873
Research and development
90
95
183
191
Acquired in-process research and development and milestones
1
—
1
6
Restructuring costs
—
2
31
88
Interest expense
108
131
219
255
Exchange losses (gains)
2
(
1
)
9
(
5
)
Other expense (income), net
29
(
35
)
(
67
)
(
23
)
Income before income taxes
183
229
396
330
Income tax expense
75
84
142
98
Net income
$
108
$
145
$
254
$
232
Earnings per share:
Basic
$
0.41
$
0.56
$
0.97
$
0.90
Diluted
$
0.40
$
0.56
$
0.95
$
0.89
Weighted average shares outstanding:
Basic
262,611
259,939
261,497
258,906
Diluted
270,449
260,156
266,679
260,584
The accompanying notes are an integral part of these interim Condensed Consolidated Financial Statements.
-3-
Table of Contents
Organon & Co.
Condensed Consolidated Statements of Comprehensive Income
(Unaudited, $ in millions)
Three Months Ended
June 30,
Six Months Ended
June 30,
2026
2025
2026
2025
Net income
$
108
$
145
$
254
$
232
Other Comprehensive (Loss) Income, Net of Taxes:
Benefit plan net gain and prior service credit, net of amortization
—
—
1
—
Cumulative translation adjustment
(
9
)
45
(
22
)
77
(
9
)
45
(
21
)
77
Comprehensive income
$
99
$
190
$
233
$
309
The accompanying notes are an integral part of these interim Condensed Consolidated Financial Statements.
-4-
Table of Contents
Organon & Co.
Condensed Consolidated Balance Sheets
(Unaudited, $ in millions except shares in thousands and per share amounts)
June 30, 2026
December 31, 2025
Assets
Current Assets:
Cash and cash equivalents
$
1,132
$
574
Accounts receivable (net of allowance for doubtful accounts of $
13
in
2026 and $
12
in 2025)
1,492
1,331
Inventories (excludes inventories of $
273
in 2026 and $
236
in 2025 classified in Other assets)
1,351
1,406
Other current assets
1,136
1,033
Assets held for sale
—
8
Total Current Assets
5,111
4,352
Property, plant and equipment, net
1,281
1,303
Goodwill
4,153
4,153
Intangibles, net
1,112
1,130
Other assets
1,521
1,539
Noncurrent assets held for sale
—
390
Total Assets
$
13,178
$
12,867
Liabilities and Equity
Current Liabilities:
Current portion of long-term debt and short-term borrowings
$
74
$
16
Trade accounts payable
1,051
952
Accrued and other current liabilities
1,407
1,335
Income taxes payable
84
85
Liabilities held for sale
—
2
Total Current Liabilities
2,616
2,390
Long-term debt
8,479
8,628
Deferred income taxes
51
57
Other noncurrent liabilities
1,026
1,008
Noncurrent liabilities held for sale
—
32
Total Liabilities
12,172
12,115
Contingencies (Note 15)
Organon & Co. Stockholders’ Equity:
Common stock, $
0.01
par value
Authorized -
500,000
Issued and outstanding -
262,609
in 2026 and
260,316
in 2025
3
3
Additional paid-in capital
199
167
Retained earnings
1,352
1,109
Accumulated other comprehensive loss
(
548
)
(
527
)
Total Stockholders’ Equity
1,006
752
Total Liabilities and Stockholders’ Equity
$
13,178
$
12,867
The accompanying notes are an integral part of these interim Condensed Consolidated Financial Statements.
-5-
Table of Contents
Organon & Co.
Condensed Consolidated Statements of Stockholders’ Equity
(Unaudited, $ in millions, except shares in thousands and per share amounts)
Common Stock
Additional Paid-In Capital
Retained Earnings
Accumulated
Other
Comprehensive (Loss)
Income
Total
Shares
Par Value
Balance at April 1, 2025
257,950
$
3
$
130
$
1,026
$
(
617
)
$
542
Net income
—
—
—
145
—
145
Other comprehensive income, net of taxes
—
—
—
—
45
45
Cash dividends declared on common stock ($
0.02
per share)
—
—
—
(
8
)
—
(
8
)
Stock-based compensation plans and other
2,015
—
9
—
—
9
Balance at June 30, 2025
259,965
$
3
$
139
$
1,163
$
(
572
)
$
733
Balance at April 1, 2026
262,649
$
3
$
186
$
1,253
$
(
539
)
$
903
Net income
—
—
—
108
—
108
Other comprehensive loss, net of taxes
—
—
—
—
(
9
)
(
9
)
Cash dividends declared on common stock ($
0.02
per share)
—
—
—
(
9
)
—
(
9
)
Stock-based compensation plans and other
(
40
)
—
13
—
—
13
Balance at June 30, 2026
262,609
$
3
$
199
$
1,352
$
(
548
)
$
1,006
Balance at January 1, 2025
257,799
$
3
$
108
$
1,010
$
(
649
)
$
472
Net income
—
—
—
232
—
232
Other comprehensive income, net of taxes
—
—
—
—
77
77
Cash dividends declared on common stock ($
0.30
per share)
—
—
—
(
79
)
—
(
79
)
Stock-based compensation plans and other
2,166
—
31
—
—
31
Balance at June 30, 2025
259,965
$
3
$
139
$
1,163
$
(
572
)
$
733
Balance at January 1, 2026
260,316
$
3
$
167
$
1,109
$
(
527
)
$
752
Net income
—
—
—
254
—
254
Other comprehensive loss, net of taxes
—
—
—
—
(
21
)
(
21
)
Cash dividends declared on common stock ($
0.04
per share)
—
—
—
(
11
)
—
(
11
)
Stock-based compensation plans and other
2,293
—
32
—
—
32
Balance at June 30, 2026
262,609
$
3
$
199
$
1,352
$
(
548
)
$
1,006
The accompanying notes are an integral part of these interim Condensed Consolidated Financial Statements.
-6-
Table of Contents
Organon & Co.
Condensed Consolidated Statements of Cash Flows
(Unaudited, $ in millions)
Six Months Ended June 30,
2026
2025
Cash Flows from Operating Activities
Net income
$
254
$
232
Adjustments to reconcile net income to net cash flows provided by operating activities:
Depreciation
73
70
Amortization
93
103
Impairment of assets
—
9
Acquired in-process research and development and milestones
1
6
Accretion and changes in fair value in contingent consideration
4
23
Deferred income tax expense (benefit)
19
(
7
)
Stock-based compensation
44
46
Unrealized foreign exchange (gain) loss
(
9
)
1
Gain on sale of
Jada
(
81
)
—
Gain on debt repurchase
—
(
46
)
Other
17
44
Net changes in assets and liabilities, net of assets acquired
Accounts receivable
(
176
)
(
76
)
Inventories
(
24
)
(
31
)
Other current assets
(
91
)
(
78
)
Trade accounts payable
106
(
109
)
Accrued and other current liabilities
75
(
59
)
Income taxes payable
3
46
Other
24
121
Net Cash Flows Provided by Operating Activities
332
295
Cash Flows from Investing Activities
Capital expenditures
(
79
)
(
71
)
Proceeds from sale of property, plant and equipment
—
1
Acquired in-process research and development and milestones
(
10
)
(
10
)
Proceeds from sale of
Jada
433
—
Dermavant acquisition, net of cash acquired
—
(
75
)
Purchase of product rights and asset acquisition
(
34
)
(
55
)
Net Cash Flows Provided by (Used) in Investing Activities
310
(
210
)
Cash Flows from Financing Activities
Proceeds from debt
—
430
Repayments of debt
(
32
)
(
634
)
Employee withholding taxes related to stock-based awards
(
7
)
(
13
)
Dividend payments
(
11
)
(
81
)
Net Cash Flows Used in Financing Activities
(
50
)
(
298
)
Effect of Exchange Rate Changes on Cash and Cash Equivalents
(
34
)
137
Net Increase (Decrease) in Cash and Cash Equivalents
558
(
76
)
Cash and Cash Equivalents, Beginning of Period
574
675
Cash and Cash Equivalents, End of Period
$
1,132
$
599
The accompanying notes are an integral part of these interim Condensed Consolidated Financial Statements.
-7-
Table of Contents
Notes to Condensed Consolidated Financial Statements (unaudited)
1.
Background and Nature of Operations
Organon & Co. (“Organon” or the “Company”) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over
70
products across women’s health and general medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 countries and territories. The Company sells these products through various channels including drug wholesalers and retailers, hospitals, government agencies and managed healthcare providers such as health maintenance organizations, pharmacy benefit managers and other institutions. The Company operates
six
manufacturing facilities, which are located in Belgium, Brazil, Indonesia, Mexico, the Netherlands and the United Kingdom (“UK”). Unless otherwise indicated, trademarks appearing in italics throughout this document are trademarks of, or are used under license by, the Organon group of companies.
Organon’s operations include the following product portfolios:
•
Women’s Health
: Organon’s health portfolio of products is sold by prescription primarily in two therapeutic areas: contraception, with key brands such as
Nexplanon®
(etonogestrel implant) (sold as
Implanon NXT
™ in some countries outside the United States) and
NuvaRing®
(etonogestrel / ethinyl estradiol vaginal ring); and fertility, with key brands such as
Follistim AQ®
(follitropin beta injection) (marketed in most countries outside the United States as
Puregon
™).
Nexplanon
is a long-acting reversible contraceptive in a class recognized as one of the most effective types of hormonal contraception available to patients with a low long-term average cost. The
Jada®
2
device
is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. In January 2026, the Company divested the
Jada
® System to Laborie Medical Technologies Corporation (“Laborie”).
•
General Medicines:
Organon’s general medicines portfolio includes biosimilars and established brands.
•
Biosimilars
: Organon’s current biosimilars portfolio spans across immunology and oncology related treatments. Organon’s oncology biosimilars:
Ontruzant®
(trastuzumab-dttb),
Aybintio
TM1
(bevacizumab),
Bildyos®
(denosumab-nxxp) and
Bilprevda®
(denosumab-nxxp) have been launched in more than 20 countries. Organon’s immunology biosimilars consist of:
Brenzys
TM1
(etanercept),
Renflexi
s
®
(infliximab-abda),
Hadlima®
(adalimumab-bwwd) and
Tofidence®
(tocilizumab-bavi).
Brenzys
,
Renflexis
, and
Hadlima
have been launched in five countries. In 2025, Organon launched
Bildyo
s injection 60 mg/mL and
Bilprevda
injection 120 mg/1.7 mL, biosimilars to
Prolia
2
(denosumab) and
Xgeva
2
(denosumab), respectively, in the United States. In 2025,
Poherdy®
(pertuzumab-dpzb) was approved by the U.S. Food and Drug Administration (“FDA”), and the Company is assessing the future commercial launch of this product.
•
Established Brands
: Organon has a portfolio of established brands, which includes brands in cardiovascular, respiratory, dermatology and non-opioid pain management, including
Emgality
®
2
(galcanezumab-gnlm) and
Vtama
® (tapinarof) cream 1%. Many brands in the established brands portfolio lost exclusivity years ago and have faced generic competition for some time.
On April 26, 2026, the Company entered into a definitive agreement with Sun Pharmaceutical Industries Limited (“Sun Pharma”) under which Sun Pharma will acquire all of the Company’s outstanding shares of common stock for $
14.00
per share in cash. Completion of the transaction is subject to customary closing conditions, including receipt of required regulatory approvals and approval by the Company’s stockholders. On July 23, 2026, the Company received stockholder approval at its special meeting of stockholders. The transaction is expected to close in early 2027.
2.
Basis of Presentation
The accompanying unaudited financial statements have been prepared in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”) and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, certain information and disclosures required by GAAP for complete consolidated financial statements are not included herein. The results of operations for any interim period are not necessarily indicative of the results of operations for the full year. In the Company’s opinion, all adjustments necessary for a fair statement of these interim statements have been included and are of a normal and recurring nature. All intercompany transactions and accounts within Organon have been eliminated. These interim statements should be read in conjunction with the audited financial statements and notes thereto included in Organon’s Annual Report on Form 10-K for the year ended December 31, 2025.
-8-
Table of Contents
Notes to Condensed Consolidated Financial Statements (unaudited)
Use of Estimates
The presentation of these Condensed Consolidated Financial Statements and accompanying notes in conformity with GAAP require management to make estimates and assumptions that affect the amounts reported, as further described in the Annual Report on Form 10-K for the year ended December 31, 2025. Accordingly, actual results could differ materially from management’s estimates and assumptions.
Recently Issued Accounting Standards Not Yet Adopted
In October 2025, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2025-07,
Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic 606): Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract
. Among other things, the ASU adds the scope exception from derivative accounting for contracts that are not exchange-traded and have features based on operations or activities specific to one of the parties involved, reducing complexity and diversity in practice. The amendments in this ASU are effective for annual periods beginning on January 1, 2027, and should be applied on a prospective basis, with the option to apply the amendments on a modified retrospective basis; early adoption is permitted. The Company is currently assessing the impact of this ASU on its consolidated financial statements and related disclosures.
In September 2025, the FASB issued ASU No. 2025-06,
Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software
. The amendments modernize the accounting for internal-use software to better reflect contemporary development practices, such as agile and iterative methodologies. Key changes include revised cost capitalization thresholds, enhanced guidance for assessing development uncertainty, and new disclosure requirements intended to improve transparency and consistency across entities. The amendments in this ASU are effective for annual periods beginning on January 1, 2028 and interim reporting periods within those periods, and may be applied either prospectively, retrospectively or on a modified retrospective basis; early adoption is permitted. The Company is currently assessing the impact of this ASU on its consolidated financial statements and related disclosures.
In November 2024, the FASB issued ASU No. 2024-03,
Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures,
Additionally, in January 2025, the FASB issued ASU 2025-01 to clarify the effective date of ASU 2024-03.
The standard requires entities to disaggregate operating expenses into specific categories to provide enhanced transparency into the nature and function of expenses. This guidance is effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. This guidance should be applied either prospectively to financial statements issued for reporting periods after the effective date or retrospectively to any or all prior periods presented in the consolidated financial statements. This ASU will have no impact on the Company’s consolidated financial condition or results of operations. The Company is currently evaluating the effects of this guidance on its related disclosures.
3.
Acquisitions and Licensing Arrangements
Shanghai Henlius Biotech, Inc. (“Henlius”)
In the first quarter of 2026, in anticipation of the expected launch of HLX-11 in the United States, the Company entered into an agreement with Henlius that amended the terms of the existing license agreement to modify the previous commercial milestone payments. Under the amended agreement, the Company will make payments of $
17
million total, with $
10
million payable in December 2026, and $
7
million, payable in February 2028. The Company capitalized the $
17
million as an intangible asset.
In April 2026, the European Commission granted marketing authorization for
Poherdy
® (pertuzumab) 420 mg/14 mL injection for intravenous use, the first and only approved biosimilar to
Perjeta
2
(pertuzumab) in Europe, for all indications of the product. As a result, sales-based milestones related to the Henlius agreement were determined to be probable of being achieved and the Company recognized intangible assets of $
10
million related to these milestones.
Sebela Pharmaceuticals (“Sebela”)
On February 19, 2026, Organon entered into an exclusive license agreement with Sebela for the global rights to
Miudella
®, a hormone-free copper intrauterine device (“IUD”) that was approved by the FDA on February 24, 2025. Under the terms of the agreement, Organon paid $
27.5
million in June 2026, with potential sales-based milestone payments of up to $
505
million, and tiered double-digit royalties based on net sales. In the second quarter of 2026, the Company recognized an intangible asset of $
27.5
million. The intangible assets will be amortized over
8
years.
-9-
Table of Contents
Notes to Condensed Consolidated Financial Statements (unaudited)
Laborie Medical Technologies Corporation (“Laborie”)
In January 2026, the Company divested the
Jada
System to Laborie for an aggregate payment of up to $
465
million, comprised of consideration of $
440
million, subject to certain customary closing adjustments, including inventory value, plus potential contingent consideration payments of up to $
25
million based on the achievement of certain 2026 net sales targets. Approximately
100
Company employees transferred to Laborie as part of this transaction.
Upon the closing of the divestiture, the Company recognized a net gain on the sale of the
Jada
System of $
81
million recognized in
Other expense (income), net
in the Condensed Consolidated Statement of Income for the six months ended June 30, 2026.
As part of the divestiture of the
Jada
System in January 2026, the Company is eligible to receive potential contingent consideration of up to $
25
million based on the achievement of certain net sales targets for the
Jada
System during 2026. This contingent consideration is recorded as a financial asset at fair value. The fair value of the contingent consideration was estimated using the projected future net sales of the
Jada
System and the probability of various achievement scenarios for the sales targets. See Note 11. “Financial Instruments” for further information.
In connection with the
Jada
divestiture, certain related assets and liabilities met the criteria for held for sale classification as of December 31, 2025. The disposal group is measured at the lower of carrying amount or fair value less cost to sell. No impairment was recognized.
Details of assets and liabilities held for sale as of December 31, 2025 are as follows:
Inventory
$
8
Assets held for sale
$
8
Goodwill
$
226
Intangible assets, net
164
Noncurrent assets held for sale
$
390
Accrued and other current liabilities
$
2
Liabilities held for sale
$
2
Deferred taxes
$
32
Noncurrent liabilities held for sale
$
32
Oss Biotech Site
In July 2025, Organon acquired the Oss Biotech manufacturing facility in the Netherlands from Merck & Co., Inc., Rahway, NJ, U.S. (“Merck”). This agreement covers Organon’s fertility drug substance production and associated support functions. Organon paid aggregate consideration of $
25
million for the facility, of which $
15
million was paid in July 2025, with the remainder paid during the second quarter of 2026. In addition to the purchase of the facility, the Company also paid $
71
million for the purchase of the remaining inventory at the site.
-10-
Table of Contents
Notes to Condensed Consolidated Financial Statements (unaudited)
4.
Earnings per Share (“EPS”)
The calculations of basic and diluted EPS are as follows:
Three Months Ended
June 30,
Six Months Ended
June 30,
($ in millions and shares in thousands, except per share amounts)
2026
2025
2026
2025
Net income
$
108
$
145
$
254
$
232
Basic weighted average number of shares outstanding
262,611
259,939
261,497
258,906
Stock awards and equity units (share equivalent)
7,838
217
5,182
1,678
Diluted weighted average common shares outstanding
270,449
260,156
266,679
260,584
EPS:
Basic
$
0.41
$
0.56
$
0.97
$
0.90
Diluted
$
0.40
$
0.56
$
0.95
$
0.89
Anti-dilutive shares excluded from the calculation of EPS
9,337
18,568
9,029
17,761
Diluted EPS was computed using the treasury stock method for stock option awards, performance share units, and restricted share units. The computation of diluted EPS excludes the effect of the potential exercise of stock-based awards when the effect of the potential exercise would be anti-dilutive.
-11-
Table of Contents
Notes to Condensed Consolidated Financial Statements (unaudited)
5.
Product and Geographic Information
Revenues of the Company’s products were as follows:
Three Months Ended June 30,
Six Months Ended June 30,
2026
2025
2026
2025
($ in millions)
U.S.
Int’l
Total
U.S.
Int’l
Total
U.S.
Int’l
Total
U.S.
Int’l
Total
Women’s Health
Nexplanon/Implanon NXT
$
129
$
101
$
230
$
163
$
77
$
240
$
256
$
175
$
431
$
339
$
148
$
488
Follistim AQ
17
43
59
30
43
74
38
82
120
65
77
142
NuvaRing
9
18
27
7
21
28
14
37
51
13
37
50
Ganirelix Acetate Injection
2
24
26
3
25
27
4
48
52
7
47
54
Marvelon/Mercilon
—
32
32
—
33
33
—
58
58
—
72
72
Jada
(3)
—
—
—
18
—
18
5
—
5
33
—
33
Other Women’s Health
(
1)
15
29
45
14
27
42
33
58
90
30
57
86
General Medicines
Biosimilars
Renflexis
44
21
65
46
17
63
87
36
122
90
30
120
Hadlima
55
24
79
36
14
50
106
40
146
69
27
96
Ontruzant
5
1
6
5
26
31
9
2
11
8
41
49
Brenzys
—
14
14
—
22
22
—
34
34
—
36
36
Bildyos/Bilprevda
14
5
19
—
—
—
20
15
35
—
—
—
Other Biosimilars
(1)
10
2
12
3
4
7
15
5
20
3
10
13
Established Brands
Cardiovascular
Atozet
—
80
80
—
86
86
—
165
165
—
162
162
Zetia
2
95
96
1
72
74
3
181
183
3
156
159
Cozaar/Hyzaar
2
48
50
2
54
56
5
103
107
4
107
111
Vytorin
1
20
21
1
26
27
2
40
42
2
48
50
Rosuzet
—
5
5
—
6
6
—
11
11
—
10
10
Other Cardiovascular
(1)
1
23
25
1
33
34
1
50
53
1
64
65
Respiratory
Singulair
2
46
48
2
64
66
4
84
88
4
136
140
Nasonex
—
58
58
—
66
66
—
123
123
—
137
137
Dulera
30
11
41
32
9
41
53
23
76
66
19
84
Clarinex
1
30
30
1
33
34
2
60
61
1
67
68
Other Respiratory
(1)
16
1
18
11
3
14
27
3
30
21
6
27
Non-Opioid Pain, Bone and Dermatology
Arcoxia
—
69
69
—
63
63
—
128
128
—
124
124
Fosamax
1
24
25
—
34
34
1
53
54
2
65
67
Diprospan
—
44
44
—
41
41
—
79
79
—
71
71
Vtama
34
1
35
29
2
31
57
3
60
49
6
54
Other Non-Opioid Pain, Bone and Dermatology
(1)
4
75
79
4
76
80
7
140
147
7
143
151
Other
Propecia
2
34
36
1
30
32
3
62
65
3
55
58
Emgality
—
54
54
—
42
42
—
108
108
—
74
74
Proscar
—
20
20
—
22
22
—
46
46
—
46
46
Other
(1)
2
94
96
3
85
87
4
178
184
5
159
164
Other
(2)
—
14
14
1
24
23
—
32
33
1
44
46
Revenues
$
398
$
1,160
$
1,558
$
414
$
1,180
$
1,594
$
756
$
2,262
$
3,018
$
826
$
2,281
$
3,107
Totals may not foot due to rounding. Trademarks appearing above in italics are trademarks of, or are used under license by, the Organon group of companies unless otherwise indicated.
(1) Includes sales of products not listed separately.
(2)
Includes manufacturing sales to third parties.
(3)
Jada
is a trademark registered in the US in the name of Alydia Health, Inc.
-12-
Table of Contents
Notes to Condensed Consolidated Financial Statements (unaudited)
Revenues by geographic area where derived are as follows:
Three Months Ended
June 30,
Six Months Ended
June 30,
($ in millions)
2026
2025
2026
2025
Europe and Canada
$
432
$
419
$
845
$
795
United States
398
414
756
826
Asia Pacific and Japan
232
250
457
502
China
208
204
402
409
Latin America, Middle East, Russia, and Africa
269
285
516
524
Other
(1)
19
22
42
51
Revenues
$
1,558
$
1,594
$
3,018
$
3,107
(1) Includes manufacturing sales to third parties.
6.
Stock-Based Compensation Plans
The Company grants stock option awards, restricted share units (“RSUs”), performance share units (“PSUs”), and cash awards pursuant to the 2021 Incentive Stock Plan.
Stock-based compensation expenses incurred by the Company were as follows:
Three Months Ended
June 30,
Six Months Ended
June 30,
($ in millions)
2026
2025
2026
2025
Stock-based compensation expense recognized in:
Cost of sales
$
4
$
4
$
7
$
8
Selling, general and administrative
16
14
29
30
Research and development
5
4
8
8
Total
$
25
$
22
$
44
$
46
Income tax benefits
$
5
$
5
$
9
$
10
The fair value of options granted was determined using the following assumptions:
Six Months Ended June 30,
2025
Expected dividend yield
7.41
%
Risk-free interest rate
4.08
Expected volatility
40.25
Expected life (years)
(1)
5.89
(1)
The expected term was estimated using the historical option‑exercise and settlement patterns, supplemented by a midpoint‑based assumption applied to awards meeting a one‑year post‑grant eligibility filter.
-13-
Table of Contents
Notes to Condensed Consolidated Financial Statements (unaudited)
A summary of the equity award transactions for the six months ended June 30, 2026 is as follows:
Stock Options
RSUs
PSUs
(shares in thousands)
Shares
Weighted average
exercise price
Weighted average
grant date
fair value
Shares
Weighted average
grant date
fair value
Shares
Weighted average
grant date
fair value
Outstanding as of January 1, 2026
7,519
$
27.30
$
6.99
9,716
$
15.35
589
$
23.61
Granted/Issued
—
—
—
13,585
6.02
2,128
8.27
Vested/Exercised
—
—
—
(
3,497
)
17.81
(
193
)
23.20
Forfeited/Cancelled
(
2,299
)
30.78
8.11
(
1,053
)
9.68
(
140
)
23.20
Outstanding as of June 30, 2026
5,220
$
25.76
$
6.50
18,751
$
8.45
2,384
$
9.98
The following table summarizes information about equity awards outstanding that are vested and expected to vest and equity awards outstanding that are exercisable as of June 30, 2026:
Equity Awards Vested and Expected to Vest
Equity Awards That are Exercisable
(awards in thousands; aggregate intrinsic value in millions)
Awards
Weighted Average
Exercise Price
Aggregate
Intrinsic Value
Remaining
Term
(in years)
Awards
Weighted Average
Exercise Price
Aggregate
Intrinsic Value
Remaining
Term
(in years)
Stock Options
5,126
$
25.76
$
—
6.23
3,949
$
29.00
$
—
5.49
RSUs
17,065
254
2.19
PSUs
2,328
36
2.22
The amount of unrecognized compensation costs as of June 30, 2026 was $
162
million, which will be recognized in operating expense ratably over the weighted average vesting period of
2.16
years.
7.
Restructuring
During the first quarter of 2026, the Company implemented restructuring initiatives that will result in an approximate
3
% headcount reduction, to streamline and optimize the Company's research and development and manufacturing operations, focusing on enhancing efficiency and aligning resources with strategic priorities. The
Restructuring costs
primarily consist of employee termination benefits and other associated expenses.
During the first quarter of 2025, the Company implemented restructuring initiatives to drive an enterprise-wide operating model optimization that resulted in an approximate
6
% headcount reduction. The restructuring activities were initiated to streamline and simplify the Company’s operating model to create more efficient processes and a simplified structure.
Restructuring costs
include separation costs associated with manufacturing-related headcount reductions.
The following is a summary of changes in severance liabilities related to the restructuring activities included within
Accrued and other current liabilities
:
June 30, 2026
December 31, 2025
Beginning balance
$
8
$
14
Severance & severance related costs
31
95
Cash payments and other
(
23
)
(
101
)
Ending balance
$
16
$
8
Organon expects the remaining severance payments associated with the restructuring activities to be paid within the next twelve months.
-14-
Table of Contents
Notes to Condensed Consolidated Financial Statements (unaudited)
8.
Taxes on Income
The effective income tax rates were
41.3
% and
37.0
% for the three months ended June 30, 2026 and 2025, respectively, and
36.0
% and
29.8
% for the six months ended June 30, 2026 and 2025, respectively. These effective income tax rates reflect the beneficial impact of foreign earnings, offset by the impact of U.S. inclusions under the Global Intangible Low-Taxed Income regime and a valuation allowance recorded against non-deductible U.S. interest expense. Also included in the six month tax rate is the beneficial impact of the sale of the
Jada
System. There was a favorable impact to the 2025 year-to-date effective tax rate driven by a tax amortization benefit.
On July 4, 2025, U.S. House Resolution 1, referred to as the One Big Beautiful Bill Act (“OBBBA”), was signed into law. The OBBBA includes significant corporate tax provisions such as modifications to interest deductibility, the option to fully expense U.S.-based R&D costs, and changes to the taxation of foreign earnings. For 2026 and beyond, the impacts of the OBBBA are reflected in the Company’s U.S. cash tax liability and income tax provision primarily reflected as an increase in the Company’s interest expense limitation offset by a decrease in the Company’s foreign income inclusions.
9.
Inventories
Inventories consisted of:
($ in millions)
June 30, 2026
December 31, 2025
Finished goods
$
686
$
751
Raw materials
12
14
Work in process
845
791
Supplies
78
81
Total (approximates current cost)
$
1,621
$
1,637
Increase (Decrease) to last in, first out (“LIFO”) costs
3
5
$
1,624
$
1,642
Recognized as:
Inventories
$
1,351
$
1,406
Other assets
273
236
Inventories valued under the LIFO method
155
114
In connection with the
Jada
divestiture in January 2026, $
8
million of inventory was reclassified to
Assets held for sale
on the Consolidated Balance Sheet as of December 31, 2025.
As part of the Dermavant acquisition in 2024, the Company acquired $
97
million of inventory, which included a $
63
million purchase accounting inventory fair value adjustment. As of June 30, 2026, the amount has been fully expensed. As of December 31, 2025, there was $
7
million remaining in inventory related to the fair value adjustment.
Amounts recognized as
Other assets
are comprised primarily of raw materials and work in process inventories and are not expected to be converted to finished goods that will be sold within one year. The Company has long-term vendor supply contracts that include certain annual minimum purchase commitments.
-15-
Table of Contents
Notes to Condensed Consolidated Financial Statements (unaudited)
10.
Long-Term Debt and Short-Term Borrowings
Long-term debt and short-term borrowings consist of the following:
($ in millions)
June 30, 2026
December 31, 2025
Senior Credit Agreement
Term Loan B Facility:
SOFR plus
225
bps term loan due 2031
$
1,522
$
1,543
EURIBOR plus
275
bps euro-denominated term loan due 2031 (€
707
million in 2026 and €
717
million in 2025)
806
843
4.125
% secured notes due 2028
2,100
2,100
2.875
% euro-denominated secured notes due 2028 (€
1.25
billion)
1,425
1,470
5.125
% notes due 2031
1,582
1,582
6.750
% secured notes due 2034
500
500
7.875
% notes due 2034
500
500
Revenue Interest Purchase and Sale Agreement
(1)
182
179
Other borrowings
8
8
Other (discounts and debt issuance costs)
(
72
)
(
81
)
Total principal long-term debt and short-term borrowings
$
8,553
$
8,644
Less: Current portion of long-term debt and short-term borrowings
74
16
Total Long-term debt, net of current portion
$
8,479
$
8,628
(1) Recognized at the amortized cost basis. The remaining principal is determined as the initial fair value less principal payments. As of June 30, 2026, the remaining principal of the revenue interest purchase and sale agreement (the “RIPSA”) that the Company assumed in connection with its 2024 acquisition of Dermavant is $
156
million.
The nature and terms of Organon’s long-term debt are described in detail in Note 12. “Long-Term Debt and Leases” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.
On February 6, 2026, the Company made mandatory prepayments from the proceeds of the
Jada
System divestiture of $
20.4
million on the U.S. Dollar Term Loans and €
9.6
million on the Euro Term Loan Facility. Additional mandatory prepayments totaling $
55
million are required across the Company’s senior secured notes within
450
days of the January 2026 closing of the
Jada
System divestiture.
For the six months ended June 30, 2026, the Company had no borrowings or repayments on the Company’s Revolving Credit Facility (the “Revolving Credit Facility”). There were no outstanding balances under the Revolving Credit Facility as of June 30, 2026 or December 31, 2025.
Long-term debt
was recorded at the carrying amount. The estimated fair value of
long-term debt
(including current portion) is as follows:
($ in millions)
Fair Value Measurement Level
June 30, 2026
December 31, 2025
Long-term debt
2
$
8,438
$
7,922
Long-term debt - RIPSA
3
134
136
Level 2 was estimated using inputs other than quoted prices in active markets for identical assets and liabilities that are observable either directly or indirectly for substantially the full term of the liability. Level 3 was estimated using unobservable inputs.
The Company made interest payments related to its debt instruments of $
209
million for the six months ended June 30, 2026. The average maturity of the Company’s long-term debt as of June 30, 2026 is approximately
4.1
years and the weighted-average interest rate on total borrowings as of June 30, 2026 is
4.9
%.
-16-
Table of Contents
Notes to Condensed Consolidated Financial Statements (unaudited)
The schedule of principal payments required on long-term debt and short-term borrowings for the next five years, exclusive of $
26
million of accrued interest related to the RIPSA, and thereafter are as follows:
($ in millions)
2026
$
1
2027
61
2028
3,486
2029
9
2030
21
Thereafter
5,021
The Senior Credit Agreement contains customary financial covenants, including a total leverage ratio covenant, which measures the ratio of (i) consolidated total debt to (ii) consolidated earnings before interest, taxes, depreciation and amortization, and subject to other adjustments, that must meet certain defined limits which are tested on a quarterly basis. In addition, the Senior Credit Agreement contains covenants that limit, among other things, Organon’s ability to prepay, redeem or repurchase its subordinated and junior lien debt, incur additional debt, make acquisitions, merge with other entities, pay dividends or distributions, redeem, or repurchase equity interests, and create or become subject to liens. As of June 30, 2026, the Company is in compliance with all financial covenants, and no default or event of default has occurred.
11.
Financial Instruments
The Company measures fair value based on the prices that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include Level 1, defined as observable inputs such as quoted prices in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs for which little or no market data exists, therefore requiring an entity to develop its own assumptions.
The following financial instruments were recorded at their estimated fair value. The recurring fair value measurement of the assets and liabilities was as follows:
($ in millions)
Fair Value Measurement Level
June 30, 2026
December 31, 2025
Other current assets:
Forward contracts
2
$
16
$
12
Contingent consideration
(a)
3
9
—
Accrued and other current liabilities:
Forward contracts
2
18
11
Other noncurrent liabilities:
Contingent consideration
3
273
269
Cross-currency swap
2
58
82
(a) As part of the divestiture of the
Jada
System in January 2026, the Company is eligible to receive potential contingent consideration based on the achievement of certain net sales targets for the
Jada
System during 2026. See Note 3. “Acquisitions and Licensing Arrangements” for further information.
Foreign Currency Risk Management
The Company uses a balance sheet risk management program to partially mitigate the exposure of net monetary assets of its subsidiaries that are denominated in a currency other than a subsidiary’s functional currency from the effects of volatility in foreign exchange. In these instances, Organon principally utilizes forward exchange contracts to partially offset the effects of exchange on exposures denominated in developed country currencies, primarily the euro, Swiss franc, and Canadian dollar. For exposures in developing country currencies, the Company enters into forward contracts to partially offset the effects of exchange on exposures when it is deemed economical to do so based on a cost-benefit analysis that considers the magnitude of the exposure, the volatility of the exchange rate and the cost of the hedging instrument.
-17-
Table of Contents
Notes to Condensed Consolidated Financial Statements (unaudited)
Forward Contracts
Monetary assets and liabilities denominated in a currency other than the functional currency of a given subsidiary are remeasured at spot rates in effect on the balance sheet date with the effects of changes in spot rates reported in
Exchange losses (gains)
in the Condensed Consolidated Statements of Income
.
The forward contracts are not designated as hedges and are marked to market through
Exchange losses (gains)
in the Condensed Consolidated Statements of Income
.
Accordingly, fair value changes in the forward contracts help mitigate the changes in the value of the remeasured assets and liabilities attributable to changes in foreign currency exchange rates, except to the extent of the spot-forward differences. These differences are not significant due to the short-term nature of the contracts, which typically have average maturities at inception of less than one year. The notional amount of forward contracts was $
1.6
billion and $
1.7
billion as of June 30, 2026 and December 31, 2025, respectively. The cash flows and the related gains and losses from these contracts are reported as
Operating activities
in the Condensed Consolidated Statements of Cash Flows.
Net Investment Hedge
Euro-denominated debt instruments
Foreign exchange risk is also managed through the use of economic hedges on foreign currency balances. €
707
million of the euro-denominated term loan and €
1.25
billion of the
2.875
% euro-denominated secured notes have been designated and are effective as a hedge of the net investment in euro-denominated subsidiaries. See Note 10 “Long-Term Debt and Short-Term Borrowings” for additional details.
Cross-currency swaps
The Company entered into cross-currency swaps that mature in 2029. The Company elected to designate the fixed-for-fixed swaps as a hedge of the net investment in euro-denominated subsidiaries balance and the change in the fair value attributable to the changes in the spot rate is recorded in
Other Comprehensive Income (Loss), Net of Taxes.
Throughout the term of the swaps, the Company will pay a fixed interest rate of
5.8330
% based on the Euro notional amount of €
922
million and receive a fixed interest rate of
7.3125
% based on the U.S. dollar notional amount of $
1
billion. The notional amount based on the Euro leg of the cross-currency swaps has been designated and is effective as a hedge of the net investment in euro-denominated subsidiaries. The difference between the interest rate received and paid under the cross-currency swap agreements is recorded in
Interest expense
in the Condensed Consolidated Statements of Income. The cash flows and the related gains and losses from the periodic settlements of the cross-currency swaps are reported as
Operating Activities
in the Condensed Consolidated Statements of Cash Flows.
Foreign currency gain (loss) due to spot rate fluctuations on the euro-denominated debt instruments and the change in fair value of the cross-currency swaps resulting from hedge designation were included within
Cumulative translation adjustment
in
Other comprehensive income (loss), net of taxes:
Three Months Ended
June 30,
Six Months Ended
June 30,
($ in millions)
2026
2025
2026
2025
Euro-denominated debt instruments gain (loss)
$
22
$
(
179
)
$
71
$
(
249
)
Cross-currency swaps (loss) gain
(
3
)
(
104
)
24
(
129
)
The Condensed Consolidated Statements of Income include the impact of net (gains) losses of Organon’s derivative financial instruments:
Three Months Ended
June 30,
Six Months Ended
June 30,
($ in millions)
2026
2025
2026
2025
Derivative loss (gain) in
Exchange losses (gains)
$
13
$
(
17
)
$
25
$
(
19
)
Derivative gain in
Interest expense
(
3
)
(
1
)
(
5
)
(
5
)
-18-
Table of Contents
Notes to Condensed Consolidated Financial Statements (unaudited)
Contingent Consideration
The fair value measurement of contingent consideration arising from business combinations is determined via probability-weighted cash flows using a Monte Carlo simulation model, which are then discounted to present value. These inputs may include: (i) the estimated amount and timing of projected cash flows, (ii) the probability of the achievement of the factor(s) on which the contingency is based and (iii) the risk-adjusted discount rate used to present value the probability-weighted cash flows. Significant increases or decreases in any of those inputs in isolation could result in a significantly higher or lower fair value measurement. At June 30, 2026, the fair value measurements of acquisition-related contingent consideration were determined using discount rates ranging from
5.91
% to
7.15
%.
The following table presents a reconciliation of contingent consideration measured on a recurring basis using significant unobservable inputs (Level 3):
($ in millions)
June 30, 2026
Beginning balance
$
269
Accretion and changes in fair value in
Other expense (income), net
4
Ending balance
$
273
In the first quarter of 2026, the Company identified an approximate $
12
million error related to the fair value remeasurement of tax‑related contingent consideration, including expected net operating loss utilization. An adjustment was recorded to increase
Other (income) expense, net
during the first quarter of 2026 and relates to amounts that should have been reflected in the fourth quarter of 2025. The contingent consideration liability is appropriately stated as of June 30, 2026. The error was determined not to be material to the current or previously issued financial statements.
Concentrations of Credit Risk
Organon has established accounts receivable factoring agreements with financial institutions in certain countries to sell accounts receivable. Under these agreements, Organon factored $
216
million
and $
217
million
of accounts receivable as of June 30, 2026 and December 31, 2025, respectively, which reduced outstanding accounts receivable. The cash received from the financial institutions is reported within
Operating Activities
in the Condensed Consolidated Statements of Cash Flows. The cost of factoring such accounts receivable was not material for the six months ended June 30, 2026 and 2025.
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Notes to Condensed Consolidated Financial Statements (unaudited)
12.
Accumulated Other Comprehensive Income (Loss)
Changes in
Accumulated other comprehensive income (loss)
by component are as follows:
($ in millions)
Employee
Benefit
Plans
Cumulative
Translation
Adjustment
Accumulated Other
Comprehensive
Income (Loss)
Balance at April 1, 2025, net of taxes
$
(
17
)
$
(
600
)
$
(
617
)
Other comprehensive income, pretax
—
45
45
Tax
—
—
—
Other comprehensive income, net of taxes
—
45
45
Balance at June 30, 2025, net of taxes
$
(
17
)
$
(
555
)
$
(
572
)
Balance at April 1, 2026, net of taxes
$
5
$
(
544
)
$
(
539
)
Other comprehensive loss, pretax
—
(
9
)
(
9
)
Tax
—
—
—
Other comprehensive loss, net of taxes
—
(
9
)
(
9
)
Balance at June 30, 2026, net of taxes
$
5
$
(
553
)
$
(
548
)
Balance at January 1, 2025, net of taxes
$
(
17
)
$
(
632
)
$
(
649
)
Other comprehensive income, pretax
—
77
77
Tax
—
—
—
Other comprehensive income, net of taxes
—
77
77
Balance at June 30, 2025, net of taxes
$
(
17
)
$
(
555
)
$
(
572
)
Balance at January 1, 2026, net of taxes
$
4
$
(
531
)
$
(
527
)
Other comprehensive income (loss), pretax
1
(
22
)
(
21
)
Tax
—
—
—
Other comprehensive income (loss), net of taxes
1
(
22
)
(
21
)
Balance at June 30, 2026, net of taxes
$
5
$
(
553
)
$
(
548
)
13.
Samsung Collaboration
The Company is party to a Development and Commercialization Agreement (the “Samsung Agreement”) with Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) to develop and commercialize multiple pre-specified biosimilar candidates, which have since launched and are part of the Company's product portfolio.
On May 22, 2026, the Samsung Agreement was amended to include commercialization rights for
Pyzchiva
®
2
(ustekinumab biosimilar) in Canada. Samsung Bioepis retains full development, manufacturing, and regulatory responsibilities (“Amendment No. 8”).
On May 26, 2026, the Samsung Agreement was amended to extend commercialization rights for certain biosimilar products, including
Renflexis
and
Brenzys
, in specified markets for up to
seven years
beyond the original contract term (“Amendment No. 9”).
In connection with Amendment No. 9, the Company is required to make fixed payments totaling $
30
million over a
nine-year
period from 2026 through 2034. The Company recorded an intangible asset and corresponding liability of $
20.8
million, the present value of the future payments. The intangible asset will be amortized over
nine years
.
The liability is accreted to its contractual value over time using the effective interest method, with accretion recognized within
Interest expense
to reflect the nature of the underlying arrangement.
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Notes to Condensed Consolidated Financial Statements (unaudited)
Amendment No. 9 also includes the return of commercialization rights to Samsung for certain oncology biosimilars, including
Ontruzant
and
Aybintio
, in specified ex‑U.S. markets such as Europe, Canada, and Brazil. These returns of rights are subject to defined, phased transition and cutover periods extending from 2026 through 2029, during which the Company may continue to commercialize products and fulfill contractual obligations.
On June 2, 2026, the Samsung Agreement was amended to include commercialization rights for
Epyztek
®
2
in Australia. Samsung Bioepis retains full development, manufacturing, and regulatory responsibilities (“Amendment No. 10”).
Under the broader agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and registration of product candidates, and the Company has an exclusive license for worldwide commercialization with certain geographic exceptions specified on a product-by-product basis. The Company's access rights to each product under the agreement last for
10
years from each product's launch date on a market-by-market basis. Gross profits are shared equally in all markets with the exception of certain markets in Brazil where gross profits are shared
65
% to Samsung Bioepis and
35
% to the Company. Since the Company is the principal on sales transactions with third parties, the Company recognizes sales, cost of sales and selling, general and administrative expenses on a gross basis. Generally, profit sharing adjustments are recorded either to
Cost of sales
(after commercialization) or
Selling, general and administrative
expenses (prior to commercialization).
Summarized information related to this collaboration is as follows:
Three Months Ended
June 30,
Six Months Ended
June 30,
($ in millions)
2026
2025
2026
2025
Sales
$
166
$
170
$
318
$
311
Cost of sales
100
102
191
192
Selling, general and administrative
18
20
36
38
($ in millions)
June 30, 2026
December 31, 2025
Payables to Samsung included in
Trade accounts payable
161
94
14.
Third-Party Arrangements
On June 2, 2021, Organon and Merck entered into a Separation and Distribution Agreement (the “Separation and Distribution Agreement”). Pursuant to the Separation and Distribution Agreement, Merck agreed to spin off the Organon products into Organon, a new, publicly-traded company (the “Separation”).
The Separation was completed pursuant to the Separation and Distribution Agreement and other agreements with Merck related to the Separation. As of June 30, 2026, only one jurisdiction remains under an Interim Operating Model Agreement.
Under the manufacturing and supply agreements, the Company manufactures certain products for Merck, or its applicable affiliate, and Merck manufactures certain products for the Company, or its applicable affiliate. For details on the rights and responsibilities of the parties under the agreements, refer to Note 17 “Third-Party Arrangements” to the audited Consolidated Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.
The amounts due under such agreements were:
($ in millions)
June 30, 2026
December 31, 2025
Due from Merck in
Accounts receivable
$
143
$
98
Due to Merck in
Accounts payable
374
337
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Notes to Condensed Consolidated Financial Statements (unaudited)
Sales and cost of sales resulting from the manufacturing and supply agreements with Merck were:
Three Months Ended
June 30,
Six Months Ended
June 30,
($ in millions)
2026
2025
2026
2025
Sales
$
13
$
19
$
26
$
37
Cost of sales
10
16
21
32
15.
Contingencies
Organon is involved in various claims and legal proceedings of a nature considered normal to its business, including product liability, intellectual property, and commercial litigation, as well as certain additional matters including governmental and environmental matters.
Organon records accruals for contingencies when it is probable that a liability has been incurred and the amount can be reasonably estimated. These accruals are adjusted periodically as assessments change or additional information becomes available. Individually significant contingent losses are accrued when probable and reasonably estimable. Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable.
Given the nature of the litigation discussed in this note and the complexities involved in these matters, Organon is unable to reasonably estimate a possible loss or range of possible loss for such matters until Organon knows, among other factors, (i) which claims, if any, will survive dispositive motion practice, (ii) the extent of the claims, including the size of any potential class, particularly when damages are not specified or are indeterminate, (iii) how the discovery process will affect the litigation, (iv) the settlement posture of the other parties to the litigation, and (v) any other factors that may have a material effect on the litigation.
Organon’s decision to obtain insurance coverage is dependent on market conditions, including cost and availability, existing at the time such decisions are made. Organon has evaluated its risks and has determined that the cost of obtaining product liability insurance outweighs the likely benefits of available coverage and, as such, has no insurance for most product liabilities.
Reference is made below to certain litigation in which Merck, but not Organon, is named as a defendant. Pursuant to the Separation and Distribution Agreement, Organon is required to indemnify Merck for liabilities relating to, arising from, or resulting from such litigation.
Product Liability Litigation
Fosamax
Merck is a defendant in product liability lawsuits in the United States involving
Fosamax®
(alendronate sodium) (the “Fosamax Litigation”). As of June 30, 2026, the Fosamax
Litigation comprises approximately
498
cases in Federal court, approximately
1,478
cases in New Jersey state court,
one
case in Pennsylvania state court and approximately
149
cases in California state court. Plaintiffs in the vast majority of these cases generally allege that they sustained femur fractures and/or other bone injuries (“Femur Fractures”) associated with the use of
Fosamax
.
All federal cases alleging femur fractures have been transferred to a multidistrict litigation in the U.S. District Court for the District of New Jersey (the “Femur Fracture MDL”) where the only bellwether case tried to date,
Glynn v. Merck
, resulted in a verdict in Merck’s favor. Although many cases were previously dismissed on federal preemption grounds, subsequent appellate rulings — including a September 2024 Third Circuit decision and the U.S. Supreme Court’s June 2025 denial of certiorari — resulted in those cases being reinstated and proceeding before the court.
In New Jersey state court, the cases have been consolidated before a single judge in Middlesex County. On July 28, 2025, the Company entered into a Master Settlement Agreement with the New Jersey state and federal plaintiffs’ lawyers who represent eligible clients (“NJ MSA Attorneys”), pursuant to which, in exchange for a confidential, but non-material settlement payment, at least
95
% of the NJ MSA Attorneys’ eligible clients will release the Company and Merck from any liability related to their filed claims.
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Notes to Condensed Consolidated Financial Statements (unaudited)
In California state court, the cases have been consolidated before a single judge in Orange County, California. In the only bellwether case tried to date in California,
Galper v. Merck
, the jury returned a verdict in Merck’s favor. On February 18, 2026, the Company entered into a Master Settlement Agreement with the California plaintiffs’ lawyers and claimants pursuant to which, in exchange for a confidential, non-material settlement payment, at least
95
% of the claimants will release the Company and Merck from any liability related to their claims.
Nexplanon/Implanon
Merck is a defendant in lawsuits brought by individuals relating to the use of
Nexplanon
and
Implanon™
(etonogestrel implant). There are
two
filed product liability actions involving
Implanon
, both of which are pending in the Northern District of Ohio as well as
56
unfiled cases involving
Implanon
alleging similar injuries, all of which have been tolled under a written tolling agreement. There is
one
matter involving
Nexplanon
pending in California state court. On March 12, 2026, the Company signed a Master Settlement Agreement with the attorneys representing plaintiffs and all but
two
of the claimants with unfiled cases, pursuant to which, in exchange for a confidential, but non-material settlement payment,
56
plaintiffs and claimants will release the defendant parties from any liability for their filed and unfiled claims. As of June 30, 2026, Merck had
19
of such cases pending outside the United States, of which
seven
relate to
Implanon
and
twelve
relate to
Nexplanon
.
Securities and Stockholder Derivative Litigation
On May 27, 2025, a stockholder filed a lawsuit against the Company and certain of its officers on behalf of a putative class of stockholders who acquired Company shares between October 31, 2024 and April 30, 2025. A separate stockholder suit was filed on July 8, 2025 on behalf of a putative class of stockholders who acquired Company shares between November 3, 2022 and April 30, 2025. Both actions allege that the defendants made materially false and misleading statements regarding the Company’s capital allocation strategy, including through the use of quarterly dividends, and its debt reduction strategy.
The court consolidated the securities class actions on March 6, 2026 and appointed Teamsters Local 710 Pension Fund (the “Lead Plaintiff”) as the lead plaintiff. On May 8, 2026, the Lead Plaintiff filed an amended complaint that contained allegations similar to those raised in the complaints filed in the original, individual actions. The amended complaint also raised allegations relating to the
Nexplanon
matter (defined below). The amended complaint seeks unspecified monetary damages. On May 29, 2026, the Lead Plaintiff informed the defendants that it intended to file a second amended complaint and on June 17, 2026, the court entered an order setting the Company’s time to answer, move or otherwise respond as 60 days from the later of the date on which the court denies the Lead Plaintiff’s motion to file a second amended complaint or the date on which the Lead Plaintiff files a second amended complaint.
The same alleged misconduct also forms the basis of
two
stockholder derivative lawsuits filed against the Company, and certain of its officers and directors asserting breach of fiduciary duties arising from purportedly materially false and misleading statements. On July 7, 2025, the court consolidated each of the stockholder derivative lawsuits. Subsequently, on September 8, 2025, the court stayed the proceedings pending the final resolution of all motions to dismiss filed in the securities lawsuits.
All of the foregoing actions were filed in the U.S. District Court for the District of New Jersey and seek unspecified monetary damages and other relief.
Governmental Proceedings
From time to time, Organon and its subsidiaries receive inquiries and may be the subject of preliminary investigation activities from competitors and/or governmental authorities, including in markets outside the United States. These authorities may include regulators, administrative authorities, and law enforcement and other similar officials, and these preliminary investigation activities may include site visits, formal or informal requests or demands for documents or materials, inquiries or interviews and similar matters. Certain of these preliminary inquiries or activities may lead to the commencement of formal proceedings. Should those proceedings be determined adversely to Organon, monetary fines and/or remedial undertakings may be required. Subject to certain exceptions specified in the Separation and Distribution Agreement, Organon assumed liability for all pending and threatened legal matters related to products transferred from Merck to Organon in connection with the spinoff, including competition investigations resulting from enforcement activity concerning Merck’s conduct involving Organon’s products. Organon could be obligated to indemnify Merck for fines or penalties, or a portion thereof, resulting from such investigations.
On October 26, 2025, Organon made a voluntary self-disclosure to the U.S. Securities and Exchange Commission (the “SEC”) to advise it of an investigation conducted by the Audit Committee of the Company’s Board of Directors (the “Audit Committee”) regarding the Company’s
Nexplanon
sales to certain wholesalers in the United States (the “Nexplanon Matter”).
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Notes to Condensed Consolidated Financial Statements (unaudited)
The SEC subsequently opened an investigation into the Nexplanon Matter, and the Company intends to cooperate with any inquiries from the SEC or any other regulatory authorities. The Company cannot guarantee that it (or its directors or officers) will not be subject to future inquiries, investigations, claims, actions, or proceedings relating to the Nexplanon Matter, nor can it predict the outcome of any of the foregoing; however, regardless of outcome, any inquiries, investigations, claims, actions, or proceedings relating to the Nexplanon Matter would likely consume a significant amount of Company resources and result in considerable legal and other costs.
Patent Litigation
From time to time, generic manufacturers of pharmaceutical products file Abbreviated New Drug Applications with the FDA seeking to market generic forms of Organon’s products prior to the expiration of relevant patents owned by Organon. To protect its patent rights, Organon may file patent infringement lawsuits against such generic companies. Similar lawsuits defending Organon’s patent rights may exist in other countries. Organon intends to vigorously defend its patents, which it believes are valid, against infringement by companies attempting to market products prior to the expiration of such patents. As with any litigation, there can be no assurance of the outcomes, which, if adverse, could result in significantly shortened periods of exclusivity for these products, potential payment of damages and legal fees, and, with respect to products acquired through acquisitions, potentially significant intangible asset impairment charges.
Nexplanon
On February 24, 2025, Organon received a Paragraph IV Certification Letter notifying the Company that Xiromed Pharma Espana, S.L. (“Xiromed”) filed an abbreviated new drug application (“ANDA”) to the FDA seeking approval to market a generic version of
Nexplanon
in the United States prior to the expiration of U.S. Patent Nos. 8,722,037 (the “‘037 patent”) and 9,757,552 (the “‘552 patent”), in 2027 and 2030, respectively. On April 2, 2025, the Company sued Xiromed in the U.S. District Court for the District of New Jersey asserting that the filing of the ANDA infringed the ‘037 patent and ‘552 patent and triggering a stay of regulatory approval of Xiromed’s ANDA for up to 30 months.
Vtama
On July 22, 2026, Organon received a Paragraph IV Certification Letter under the Hatch-Waxman Act notifying the Company that Encube Ethical Private Limited (Encube) has filed an abbreviated new drug application to the FDA seeking approval to market a generic version of
Vtama
. Encube’s notice letter included a Paragraph IV certification with respect to
twelve
patents listed in the Orange Book for
Vtama
, expiring between 2036 and 2039. On July 23, 2026, Organon received a Paragraph IV Certification Letter under the Hatch-Waxman Act notifying the Company that Mylan Pharmaceuticals, Inc. (Mylan) has filed an abbreviated new drug application to the FDA seeking approval to market a generic version of
Vtama
. Mylan’s notice letter included a Paragraph IV certification with respect to
nine
patents listed in the Orange Book for
Vtama
, expiring between 2036 and 2039. On July 27, 2026, Organon received a Paragraph IV Certification Letter under the Hatch-Waxman Act notifying the Company that Natco Pharma Limited (Natco) has filed an abbreviated new drug application to the FDA seeking approval to market a generic version of
Vtama
. Natco’s notice letter included a Paragraph IV certification with respect to
nine
patents listed in the Orange Book for
Vtama
, expiring between 2036 and 2039. Organon is reviewing the details of the Paragraph IV Certification Letters and intends to defend and enforce its intellectual property rights protecting
Vtama
.
Other Matters
In addition to the matters described above, there are various other pending legal proceedings involving Organon, principally product liability and intellectual property lawsuits. While it is not feasible to predict the outcome of such proceedings, in the opinion of Organon as of June 30, 2026, either the likelihood of loss is remote or any reasonably possible loss associated with the resolution of such proceedings is not expected to be material to Organon’s financial condition, results of operations or cash flows either individually or in the aggregate.
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Notes to Condensed Consolidated Financial Statements (unaudited)
Legal Defense Reserves
Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable. Some of the significant factors considered in the review of these legal defense reserves are as follows: the actual costs incurred by Organon; the development of Organon’s legal defense strategy and structure in light of the scope of its litigation; the number of cases being brought against Organon; and the costs and outcomes of completed trials and the most current information regarding anticipated timing, progression, and related costs of pre-trial activities and trials in the associated litigation. The legal defense reserve as of June 30, 2026 and December 31, 2025 was $
8
million and $
10
million, respectively, and represented Organon’s best estimate of the minimum amount of defense costs to be incurred in connection with its outstanding litigation; however, events such as additional trials, other events that could arise in the course of pending litigation, or the filing of new matters, could affect the ultimate amount of legal defense costs to be incurred by Organon. Organon will continue to monitor its legal defense costs and review the adequacy of the associated reserves and may determine to increase the reserves at any time in the future if, based upon the factors set forth above, it believes it would be appropriate to do so.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION
Some statements and disclosures in this document are forward-looking statements. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as “may,” “believe,” “will,” “expect,” “project,” “potential,” “possible,” “probable,” “outcome,” “likely,” “could,” “should,” “estimate,” “anticipate,” “plan,” “intend,” “would,” “future,” “target,” “seek,” “continue,” and other words of similar meaning, or negative variations of any of the foregoing. These forward-looking statements are based on our current plans and expectations and are subject to a number of risks and uncertainties that could cause our plans and expectations, including actual results, to differ materially from the forward-looking statements. Risks and uncertainties that may affect our future results include, but are not limited to, uncertainties as to the timing of the proposed transaction with Sun Pharmaceutical Industries Limited (together with its subsidiaries and/or associated companies, “Sun Pharma”); the risk that the proposed transaction may not be completed on the anticipated terms in a timely manner or at all; the possibility that competing offers or acquisition proposals for Organon will be made; the possibility that any or all of the remaining conditions to the consummation of the proposed transaction may not be satisfied or waived, including the failure to receive any required regulatory approvals from any applicable governmental entities (or any conditions, limitations or restrictions placed on such approvals); the occurrence of any event, change or other circumstance that could give rise to the termination of the definitive agreement, including in circumstances that would require us to pay a termination fee; the effect of the pendency of the proposed transaction on our ability to retain and hire key personnel, our ability to maintain relationships with our customers, suppliers and others with whom we do business, or our operating results and business generally; risks related to diverting management’s attention from our ongoing business operations; the risk that stockholder litigation in connection with the proposed transaction may result in significant costs of defense, indemnification and liability; certain restrictions during the pendency of the proposed transaction that may impact our ability to pursue certain business opportunities or strategic transactions; the risk that any announcements relating to the proposed transaction could have adverse effects on the market price of our common stock, including if the proposed transaction is not consummated; risks that the benefits of the proposed transaction are not realized when and as expected; expanded brand and class competition in the markets in which we operate; trade protection measures and import or export licensing requirements, including the direct and indirect impacts of tariffs (including pharmaceutical sector tariffs), trade sanctions or similar restrictions by the United States or other governments; changes in U.S. and foreign federal, state and local governmental funding allocations including the timing and amounts allocated to our customers and business partners; the impact of global business, political and macroeconomic conditions, including inflation, interest rate fluctuations, recessionary pressures, foreign currency exchange rates, volatile market conditions, and instability in the global banking system; global events, such as regional conflicts in the Middle East and elsewhere; our ability to access the public securities and other capital and credit markets in accordance with our financial plans, the cost of such capital, and overall condition of the capital and credit markets; actions that may be taken by credit rating agencies that could negatively affect either our access to or terms of financing or our financial condition and liquidity; our ability to meet our revenue and growth expectations and outlook; our ability to retain members of our senior management and other key employees; the failure of any supplier to provide substances, materials, or services as agreed, or otherwise meet their obligations to us; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as our products lose patent protection; any failure by us to retain market exclusivity for
Nexplanon
or to obtain an additional period of exclusivity in the United States for
Nexplanon
subsequent to the expiration of the rod patents in 2027; the success of our efforts to adapt our business and sales strategies to address the changing market and regulatory landscape in order to achieve our business objectives and remain competitive; restructurings or other disruptions at the U.S. Food and Drug Administration (“FDA”), the SEC and other U.S. and comparable foreign government agencies; difficulties in connection with future strategic transactions, including as a result of the impact of macroeconomic or geopolitical developments; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to or affecting Medicare, Medicaid and healthcare reform, pharmaceutical pricing and reimbursement, access to our products, international reference pricing, including Most-Favored-Nation drug pricing, and other pricing-related initiatives and policy efforts; the impact of higher selling and promotional costs; changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, and/or marketing of our products and related intellectual property, environmental regulations, and the enforcement thereof affecting our business; efficacy, safety or other quality concerns with respect to our marketed products, whether or not scientifically justified, leading to product recalls, withdrawals, labeling changes, or declining sales; delays or failures to demonstrate adequate efficacy and safety of our product candidates in pre-clinical and clinical trials, which may prevent or delay the development, approval, clearance, or commercialization of our product candidates; reduced research and development investment and increased reliance on fewer research and development programs for new products to generate future revenue and replace existing products that come to the end of their market life cycle; future actions of third-parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of healthcare products and services, including delaying medical procedures, rationing prescription medications, reducing the
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frequency of physician visits and forgoing healthcare insurance coverage; legal factors, such as product liability claims, stockholder litigation, governmental investigations, and patent disputes; lost market opportunity resulting from delays and uncertainties in clinical trials and the approval or clearance process of the FDA and other regulatory authorities; the failure by us or our third party collaborators and/or their suppliers to fulfill our or their regulatory or quality obligations, which could lead to a delay in regulatory approval or commercial marketing of our products; cyberattacks on, or other failures, accidents, or security breaches of, our or third-party providers’ information technology systems, which could disrupt our operations and those of third parties upon which we rely; increased focus on privacy issues in countries around the world, including the United States, the European Union, and China, and a more difficult legislative and regulatory landscape for privacy and data protection that continues to evolve with the potential to directly affect our business, including recently enacted laws in a majority of states in the United States requiring security breach notification; changes in tax laws including changes related to the taxation of foreign earnings; the impact of any future pandemic, epidemic, or similar public health threat on our business, operations and financial performance; changes in accounting pronouncements promulgated by standard-setting or regulatory bodies, including the Financial Accounting Standards Board and the SEC, that are adverse to us; volatility of commodity prices, fuel, and shipping rates that impact the costs and/or ability to supply our products; and other factors discussed in our most recently filed Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and subsequent filings, including those discussed in the “Business,” “Risk Factors,” “Cautionary Statement Regarding Forward-Looking Statements” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of those reports.
General
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations is intended to assist the reader in understanding our financial condition and results of operations. The following discussion and analysis should be read in conjunction with our Condensed Consolidated Financial Statements included in Part I, Item 1 of this report and with our audited financial statements, including the accompanying notes, and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2025. Operating results discussed herein are not necessarily indicative of the results of any future period.
We are a global healthcare company with a primary focus on improving the health of women throughout their lives. We develop and deliver innovative health solutions through a portfolio of prescription therapies within our women’s health and general medicines portfolios. We have a portfolio of more than 70 medicines and products across a range of therapeutic areas. We sell these products through various channels including drug wholesalers and retailers, hospitals, government agencies and managed healthcare providers such as health maintenance organizations, pharmacy benefit managers and other institutions. We own and operate six manufacturing facilities, which are located in Belgium, Brazil, Indonesia, Mexico, the Netherlands and the United Kingdom. Unless otherwise indicated, trademarks appearing in italics throughout this document are trademarks of, or are used under license by, our group of companies.
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Recent Developments
Sun Pharma Transaction
On April 26, 2026, we entered into a definitive agreement with Sun Pharma under which Sun Pharma will acquire all of our outstanding shares of common stock for $14.00 per share in cash. Completion of the transaction is subject to customary closing conditions, including receipt of required regulatory approvals and approval by the Company’s stockholders. On July 23, 2026, the Company received stockholder approval at its special meeting of stockholders. The Company and Sun Pharma are continuing to work to satisfy the other conditions to closing. The transaction is expected to close in early 2027.
Business Development
Samsung Collaboration
On May 22, 2026, the Samsung Agreement was amended to include commercialization rights for
Pyzchiva
(ustekinumab biosimilar) in Canada. Samsung Bioepis retains full development, manufacturing, and regulatory responsibilities (“Amendment No. 8”).
Pyzchiva
is expected to launch in Canada in the second half of 2026.
On May 26, 2026, the Samsung Agreement was amended to extend commercialization rights for certain biosimilar products, including
Renflexis
and
Brenzys
, in specified markets for up to seven years beyond the original contract term (“Amendment No. 9”).
In connection with Amendment No. 9, the Company is required to make fixed payments totaling $30 million over a nine-year period from 2026 through 2034. The Company recorded an intangible asset and corresponding liability of $20.8 million, the present value of the future payments. The intangible asset will be amortized over nine years.
The liability is accreted to its contractual value over time using the effective interest method, with accretion recognized within
Interest expense
to reflect the nature of the underlying arrangement.
Amendment No. 9 also includes the return of commercialization rights to Samsung for certain oncology biosimilars, including
Ontruzant
and
Aybintio
, in specified ex‑U.S. markets such as Europe, Canada, and Brazil. These returns of rights are subject to defined, phased transition and cutover periods extending from 2026 through 2029, during which the Company may continue to commercialize products and fulfill contractual obligations.
On June 2, 2026, the Samsung Agreement was amended to include commercialization rights for
Epyztek
in Australia. Samsung Bioepis retains full development, manufacturing, and regulatory responsibilities (“Amendment No. 10”).
Epyztek
is expected to launch in Australia in the second half of 2026.
Sebela Pharmaceuticals (“Sebela”)
On February 19, 2026, we entered into an exclusive license agreement with Sebela for the global rights to
Miudella
®, a hormone-free copper intrauterine device (“IUD”) that was approved by the FDA on February 24, 2025 and is estimated to launch commercials sales in the United States in late 2026. Under the terms of the agreement, we paid $27.5 million in June 2026, with potential sales-based milestone payments of up to $505 million, and tiered double-digit royalties based on net sales. In the second quarter of 2026, the Company recognized an intangible asset of $27.5 million.
Laborie Medical Technologies Corporation (“Laborie”)
In January 2026, we divested the
Jada
System to Laborie for an aggregate payment of up to $465 million, comprised of consideration of $440 million, subject to certain closing adjustments, plus potential contingent consideration payments of up to $25 million based on the achievement of certain 2026 net sales targets. Approximately 100 Company employees transferred to Laborie as part of this transaction.
Upon the closing of the divestiture, we recognized a net gain on the sale of the
Jada
System of $81 million recognized in
Other expense (income), net
in the Condensed Consolidated Statement of Income for the six months ended June 30, 2026.
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Operating Results
Sales Overview
Three Months Ended June 30,
% Change
% Change Excluding Foreign Exchange
Six Months Ended June 30,
% Change
% Change Excluding Foreign Exchange
($ in millions)
2026
2025
2026
2025
United States
$
398
$
414
(4)
%
(4)
%
$
756
$
826
(8)
%
(8)
%
International
1,160
1,180
(2)
(5)
2,262
2,281
(1)
(6)
Total
$
1,558
$
1,594
(2)
%
(5)
%
$
3,018
$
3,107
(3)
%
(7)
%
Worldwide sales were $1.6 billion for the three months ended June 30, 2026, a decrease of 2%, compared to 2025. Worldwide sales were positively impacted by approximately $42 million or 3%, due to favorable foreign exchange rates.
Excluding the impact of foreign exchange rates, sales decreases for the three months ended June 30, 2026 primarily reflect the lower sales of:
•
Ontruzant,
due to lower tendered volume from Brazil’s Ministry of Health when compared with the same period in 2025;
•
Singulair
® (montelukast sodium)
,
primarily attributable to decreased demand due to less favorable medical guidelines in certain international markets, most recently in China, as well as temporary supply constraints in Japan and mandatory price reductions in China and Japan; and
•
Jada,
due to no longer having sales following the sale of the Jada System to Laborie in January 2026.
This performance was offset by sales increases for the three months ended June 30, 2026 in:
•
Hadlima,
due to stronger demand in the United States and Puerto Rico;
•
Zetia
® (ezetimibe)
/Vytorin
® (ezetimibe / simvastatin)
,
primarily driven by increased demand in China; and
•
Emgality,
as a result of increased demand in various international markets.
Worldwide sales were $3.0 billion for the six months ended June 30, 2026, a decrease of 3%, compared to 2025. Worldwide sales during the six months ended June 30, 2026 were positively impacted by approximately $118 million, or approximately 4%, due to favorable foreign exchange rates.
Excluding the impact of foreign exchange rates, sales decreases for the six months ended June 30, 2026, primarily reflect lower sales of:
•
Nexplanon,
primarily due to decreased physician demand in the United States following the five-year label approval as reinsertions have been delayed and there has been uncertainty around federal funding;
•
Singulair,
primarily attributable to decreased demand due to less favorable medical guidelines in certain international markets, most recently in China, as well as temporary supply constraints in Japan and mandatory price reductions in China and Japan;
•
Ontruzant,
due to lower tendered volume from Brazil’s Ministry of Health when compared with the same period in 2025; and
•
Jada,
due to no longer having sales following the sale of the Jada System to Laborie in January 2026.
This performance was offset by sales increases for the six months ended June 30, 2026 in:
•
Hadlima,
due to stronger demand in the United States and Puerto Rico;
•
Emgality,
as a result of increased demand in various international markets; and
•
Zetia/Vytorin,
primarily driven by increased demand in China.
Loss of exclusivity (“LOE”) negatively impacted sales of certain of our products by approximately $6 million and $10 million during the three and six months ended June 30, 2026, respectively, based on the decrease in sales volume of those products compared to 2025. Volume-based procurement (“VBP”) in China negatively impacted sales by approximately $5 million and $7 million during the three and six months ended June 30, 2026, respectively. We expect VBP to continue to negatively impact our general medicines product portfolio for the next several quarters.
Due to changing market conditions, including ongoing regional conflicts in the Middle East and elsewhere, new and evolving U.S. and international tariffs, U.S. tax law changes and regulatory uncertainty that impact our business, as well as the pharmaceutical industry, we have been and will continue to adapt our business and sales strategies to address this changing
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landscape in order to achieve our business objectives and remain competitive. Such strategies may include implementing or continuing to assess product discount programs and wholesaler inventory levels under the relevant agreements or waivers of their terms for certain key products.
Highlights of the sales of our products for the three and six months ended June 30, 2026 and 2025 are provided below. See Note 5 “Product and Geographic Information”
to the Condensed Consolidated Financial Statements for further details on sales of our products.
Women’s Health
Three Months Ended June 30,
% Change
% Change Excluding Foreign Exchange
Six Months Ended June 30,
% Change
% Change Excluding Foreign Exchange
($ in millions)
2026
2025
2026
2025
Nexplanon/Implanon NXT
$
230
$
240
(4)
%
(6)
%
$
431
$
488
(12)
%
(14)
%
NuvaRing
27
28
(4)
(8)
51
50
2
(5)
Marvelon/Mercilon
32
33
(4)
(5)
58
72
(20)
(22)
Follistim AQ
59
74
(19)
(21)
120
142
(16)
(18)
Jada
—
18
(100)
(100)
5
33
(84)
(84)
Contraception
Worldwide sales of
Nexplanon,
a single-rod subdermal contraceptive implant, declined 4% and 12% for the three and six months ended June 30, 2026, compared to 2025, respectively, primarily due to decreased physician demand in the United States following the five-year label approval as reinsertions have been delayed and there has been uncertainty around federal funding. We estimate that expanding use from the new label will begin to favorably offset the reinsertion headwind beginning in the second half of 2026. In 2025, we submitted a similar application for a five-year duration period of use to the EU and UK Health Authorities. The application for five-year duration was approved for the UK in April, 2026. The EU application is currently under review, with potential approval in 2027, subject to health authority review and approval. Outside of the U.S., sales were positively impacted by increased demand and access in Brazil, which we expect to continue for the remainder of 2026.
Worldwide sales of
NuvaRing
, a vaginal contraceptive product, declined 4% for the three months ended June 30, 2026, compared to 2025, due to decreased demand in various international markets, partially offset by lower discount rates in the United States. Sales of
NuvaRing
, increased 2% for the six months ended June 30, 2026, compared to 2025, due to the favorable impact of foreign exchange and lower discount rates in the United States, offset by decreased demand in various international markets.
Worldwide sales of
Marvelon™
¹ (desogestrel and ethinyl estradiol pill) and
Mercilon™
¹
(desogestrel and ethinyl estradiol pill), combined oral hormonal daily contraceptive pills not approved or marketed in the United States, but available in certain countries outside the United States, declined 4% and 20% for the three and six months ended June 30, 2026, compared to 2025, respectively, as a result of decreased demand and market contraction in China and the timing of shipments in Asia Pacific. In the second quarter of 2026, we received regulatory approval in Japan for
Mercilon
Combination Tablets, a low-dose estrogen-progestin (LEP) product for the treatment of dysmenorrhea.
Fertility
Worldwide sales of
Follistim AQ
, a fertility treatment, declined 19% and 16% for the three and six months ended June 30, 2026, compared to 2025, respectively, as a result of competitive-driven price reduction in the United States. We expect sales to continue to decline compared to 2025 for the remainder of the year, reflecting the material price decrease implemented in February 2025. We anticipate that year-over-year comparisons will stabilize once a full year has elapsed following the price reduction, assuming no additional structural price decreases occur in the interim.
Other Women’s Health
In January 2026, we completed the sale of the
Jada
System to Laborie and, thereafter, we were no longer actively selling the
Jada
System. As a result, worldwide sales of
Jada,
a device intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted, significantly declined for the three and six months ended June 30, 2026, compared to 2025, respectively.
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General Medicines
Biosimilars
Three Months Ended June 30,
% Change
% Change Excluding Foreign Exchange
Six Months Ended June 30,
% Change
% Change Excluding Foreign Exchange
($ in millions)
2026
2025
2026
2025
Renflexis
$
65
$
63
4
%
3
%
$
122
$
120
2
%
1
%
Hadlima
79
50
59
58
146
96
51
51
Ontruzant
6
31
(81)
(81)
11
49
(77)
(77)
Brenzys
14
22
(34)
(37)
34
36
(5)
(10)
Bildyos/Bilprevda
19
—
*
*
35
—
*
*
* Calculation not meaningful.
Renflexis
is a biosimilar to
Remicade
2
(infliximab) for the treatment of certain autoimmune conditions. Sales increased 4% and 2% for the three and six months ended June 30, 2026, compared to 2025, respectively, primarily due to increased demand in Canada, partially offset by competitive pressure and unfavorable discount rates in the United States.
Hadlima
is a biosimilar to
Humira
2
(adalimumab) for the treatment of certain autoimmune and autoinflammatory conditions. Sales increased 59% and 51% for the three and six months ended June 30, 2026, compared to 2025, respectively, due to stronger demand in the United States and Puerto Rico. We have commercialization rights to
Hadlima
in countries outside of the European Union, South Korea, China, Turkey, and Russia.
Hadlima
is currently approved in the United States, Australia, Canada, and Israel.
Ontruzant
is a biosimilar to
Herceptin
2
(trastuzumab) for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Sales for the three and six months ended June 30, 2026, compared to 2025, declined 81% and 77%, respectively, due to lower tendered volume from Brazil’s Ministry of Health when compared with the same period in 2025. We have commercialization rights to
Ontruzant
in all countries except in South Korea and China.
Brenzys
is a biosimilar to
Enbrel
2
(etanercept) for the treatment of certain inflammatory diseases. Sales for the three and six months ended June 30, 2026, compared to 2025, declined 34% and 5%, respectively, as a result of the timing of shipments in Brazil. We have commercialization rights to
Brenzys
in countries outside of the United States, Europe, South Korea, China, and Japan.
Bildyos
injection 60 mg/mL and
Bilprevda
injection 120 mg/1.7 mL, are biosimilars to
Prolia
and
Xgeva
, respectively, for all indications of the reference products
.
Sales were $19 million and $35 million for the three and six months ended June 30, 2026, respectively, as a result of the product launch in the third quarter of 2025.
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Established Brands
Cardiovascular
Three Months Ended June 30,
% Change
% Change Excluding Foreign Exchange
Six Months Ended June 30,
% Change
% Change Excluding Foreign Exchange
($ in millions)
2026
2025
2026
2025
Atozet
$
80
$
86
(7)
%
(9)
%
$
165
$
162
1
%
(2)
%
Zetia/Vytorin
118
101
16
12
226
209
8
3
Cozaar/Hyzaar
50
56
(10)
(13)
107
111
(3)
(7)
Sales of
Atozet™
¹ (ezetimibe and atorvastatin), a medicine for lowering LDL cholesterol, decreased 7% for the three months ended June 30, 2026 compared to 2025, due to unfavorable pricing in Europe, partially offset by increased demand in Korea. Sales of
Atozet
increased 1% for the six months ended June 30, 2026, compared to 2025, primarily due to favorable foreign exchange, increased demand in China, due to the product launch in 2025, in Asia Pacific and Korea as well as volume uptake in certain countries in Europe, partially offset by unfavorable pricing in Europe.
Combined global sales of
Zetia
, which is marketed as
Ezetrol™
in most countries outside the United States; and of
Vytorin
, which is marketed as
Inegy™
outside the United States, which are medicines for lowering LDL cholesterol, increased 16% and 8% for the three and six months ended June 30, 2026, compared to 2025, respectively, primarily driven by increased demand in China.
Combined global sales of
Cozaar
® (losartan) and
Hyzaar
® (losartan / hydrochlorothiazide), which are medicines for the treatment of hypertension, declined 10% and 3% for the three and six months ended June 30, 2026, compared to 2025, respectively, driven by decreased demand in various international markets.
Respiratory
Three Months Ended June 30,
% Change
% Change Excluding Foreign Exchange
Six Months Ended June 30,
% Change
% Change Excluding Foreign Exchange
($ in millions)
2026
2025
2026
2025
Singulair
$
48
$
66
(27)
%
(27)
%
$
88
$
140
(37)
%
(39)
%
Nasonex
58
66
(12)
(16)
123
137
(10)
(17)
Dulera
41
41
1
—
76
84
(10)
(11)
Worldwide sales of
Singulair
, a once-a-day oral medicine for the chronic treatment of asthma and for the relief of symptoms of allergic rhinitis,
declined 27% and 37% for the three and six months ended June 30, 2026, compared to 2025, respectively.
This decline during these periods was primarily attributable to decreased demand due to less favorable medical guidelines in certain international markets, most recently in China, as well as temporary supply constraints in Japan and mandatory price reductions in China and Japan.
Global sales of
Nasonex
® (mometasone furoate), an inhaled nasal corticosteroid for the treatment of nasal allergy symptoms, declined 12% and 10% for the three and six months ended June 30, 2026, compared to 2025, respectively, due to competitive pressure in various international markets.
Global sales of
Dulera
® (formoterol/fumarate dihydrate), which is also marketed as
Zenhale™
in certain markets outside of the United States, a combination medicine for the treatment of asthma, increased 1% for the three months ended June 30, 2026, compared to 2025, primarily due to the favorable impact of foreign exchange, offset by decreased demand in the United States. Global sales of
Dulera
declined 10% for the six months ended June 30, 2026, compared to 2025, primarily due to decreased demand in the United States.
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Non-Opioid Pain, Bone and Dermatology
Three Months Ended June 30,
% Change
% Change Excluding Foreign Exchange
Six Months Ended June 30,
% Change
% Change Excluding Foreign Exchange
($ in millions)
2026
2025
2026
2025
Arcoxia
$
69
$
63
11
%
6
%
$
128
$
124
3
%
(4)
%
Vtama
35
31
15
15
60
54
11
%
11
%
Sales of
Arcoxia™
¹ (etoricoxib), a medicine for the treatment of arthritis and pain, increased 11% and 3% for the three and six months ended June 30, 2026, compared to 2025, due to increased demand in China and the phasing of shipments in various international regions.
Sales of
Vtama,
a cream for the topical treatment of mild, moderate, and severe plaque psoriasis in adults and atopic dermatitis, also known as eczema, in adults and children two years of age and older, increased 15% and 11% for the three and six months ended June 30, 2026, compared to 2025, respectively, due to increased demand and favorable discount rates in the United States, partially offset by lower demand in Japan. We anticipate launching
Vtama
in certain international markets in 2026 and beyond, subject to health authority reviews and approvals.
Other
Three Months Ended June 30,
% Change
% Change Excluding Foreign Exchange
Six Months Ended June 30,
% Change
% Change Excluding Foreign Exchange
($ in millions)
2026
2025
2026
2025
Emgality
$
54
$
42
27%
20
$
108
$
74
45
%
33
%
Sales of
Emgality,
a
medicine for the preventive treatment of migraine, increased 27% and 45% for the three and six months ended June 30, 2026, compared to 2025, respectively, as a result of increased demand in various international markets.
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Gross Profit, Expenses and Other
Three Months Ended June 30,
% Change
Six Months Ended June 30,
% Change
($ in millions)
2026
2025
2026
2025
Cost of sales
$
711
$
720
(1)
%
$
1,388
$
1,392
—
%
Gross profit
847
874
(3)
1,630
1,715
(5)
Selling, general and administrative
434
453
(4)
858
873
(2)
Research and development
90
95
(5)
183
191
(4)
Acquired in-process research and development and milestones
1
—
*
1
6
(83)
Restructuring costs
—
2
(100)
31
88
(65)
Interest expense
108
131
(18)
219
255
(14)
Exchange losses (gains)
2
(1)
*
9
(5)
*
Other expense (income), net
29
(35)
*
(67)
(23)
*
* Calculation not meaningful.
Cost of Sales
Cost of sales decreased 1% and less than 1% for the three and six months ended June 30, 2026, compared to 2025, respectively, driven by our product mix and the impact of unfavorable foreign exchange.
Cost of sales for the three and six months ended June 30, 2026 includes amortization associated with the inventory fair value adjustment related to the Dermavant acquisition of $0 and $7 million, respectively, and amortization of intangible assets of $46 million and $93 million, respectively. Cost of sales for the three and six months ended June 30, 2025, includes amortization associated with the inventory fair value adjustment related to the Dermavant acquisition of $10 million and $19 million, respectively, an impairment charge related to a currently marketed women’s health product of $9 million and amortization of intangible assets of $53 million and $103 million, respectively.
Gross Profit update
Gross profit decreased 3% and 5% for the three and six months ended June 30, 2026, compared to 2025, respectively, due to the impact of unfavorable volume, pricing and product mix and unfavorable foreign exchange.
Selling, General and Administrative
Selling, general and administrative expenses decreased 4% and 2% for the three and six months ended June 30, 2026, compared to 2025, respectively, due to reduced headcount-related costs and lower spending as part of our cost-saving and restructuring initiatives.
Research and Development
Research and development expenses decreased 5% for each of the three and six months ended June 30, 2026, compared to 2025, primarily due to reduced headcount-related costs related to our restructuring initiatives and a decrease in clinical study activity. During 2025, we discontinued the clinical development programs for investigational candidates OG-6219 and OG-7191.
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Acquired In-Process Research and Development and Milestones
For the six months ended June 30, 2025, we recognized $6 million in acquired in-process research and development and milestones, related to the exit of our agreement with Suzhou Centergene Pharmaceuticals, due to the evolving fertility landscape in China.
Restructuring Costs
For the six months ended June 30, 2026, we incurred restructuring costs of $31 million related to our 2026 restructuring initiatives to streamline and optimize our research and development and manufacturing operations, focusing on enhancing efficiency and aligning resources with strategic priorities. For the six months ended June 30, 2025, we incurred restructuring costs of $88 million, comprised primarily of headcount-related restructuring expense associated with restructuring initiatives that were aimed at driving operational efficiencies in 2025.
Interest Expense
Interest expense decreased 18% and 14% for the three and six months ended June 30, 2026, compared to 2025, respectively, due to the repurchase and cancellation of approximately $419 million of the Company’s 5.125% notes due in 2031 (the “2031 Notes”) during the second and fourth quarters of 2025, mandatory prepayments to our term loans in the first quarter of 2026 and lower reference rates on our USD-denominated variable rate debt.
Exchange Losses (Gains)
Exchange losses (gains) were unfavorable for the three and six months ended June 30, 2026, compared to 2025, respectively primarily due to unfavorable movements in certain foreign currencies relative to the U.S. dollar.
Other Expense (Income), net
Other expense (income), net was impacted for the three months ended June 30, 2026, by $17 million due to an unfavorable resolution of a working capital matter related to the Dermavant acquisition and $9 million related to the fair value adjustments and accretion of the Dermavant acquisition contingent consideration, related to changes in the timing of expected commercial milestones based on updated sales forecasts. Other expense (income), net was impacted for the six months ended June 30, 2026, by an $81 million net gain related to the divestiture of the
Jada
System to Laborie in the first quarter of 2026, $17 million due to an unfavorable resolution of a working capital matter related to the Dermavant acquisition and $4 million related to the fair value adjustments and accretion of the Dermavant acquisition contingent consideration, related to changes in the timing of expected commercial milestones based on updated sales forecasts.
Taxes on Income
The effective income tax rates were 36.0% and 29.8% for the six months ended June 30, 2026 and 2025, respectively. These effective income tax rates reflect the beneficial impact of foreign earnings, offset by the impact of U.S. inclusions under the Global Intangible Low-Taxed Income regime and a valuation allowance recorded against non-deductible U.S. interest expense. Also included in the six month tax rate is the beneficial impact of the sale of the
Jada
System. There was a favorable impact to the 2025 year-to-date effective tax rate driven by a tax amortization benefit.
On July 4, 2025, U.S. House Resolution 1, referred to as the One Big Beautiful Bill Act (“OBBBA”), was signed into law. The OBBBA includes significant corporate tax provisions such as modifications to interest deductibility, the option to fully expense U.S.-based R&D costs, and changes to the taxation of foreign earnings. For 2026 and beyond, the impacts of the OBBBA are reflected in our U.S. cash tax liability and income tax provision primarily reflected as an increase in our interest expense limitation offset by a decrease in our foreign income inclusions.
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Liquidity and Capital Resources
As of June 30, 2026, we had cash and cash equivalents of $1.13 billion. We have historically generated and expect to continue to generate positive cash flow from operations. Our ability to fund our operations and anticipated capital needs is reliant upon the generation of cash from operations, supplemented as necessary by periodic utilization of our revolving credit facility. Our principal uses of cash in the future will be primarily to fund our operations, working capital needs, capital expenditures, repayment of borrowings, strategic business development transactions and the payment of dividends. We believe that our financing arrangements, future cash from operations, and access to capital markets will provide adequate resources to fund our future cash flow needs. Our ability to raise new capital or refinance our debt, will depend on the capital markets and our financial condition at such times.
Working capital is defined as current assets less current liabilities and was $2.50 billion and $1.96 billion as of June 30, 2026 and December 31, 2025, respectively. Working capital was positively impacted by our active cash cycle management, which includes the factoring of receivables and timing of vendor payments and the proceeds from the divestiture of the
Jada
System.
We have accounts receivable factoring agreements with financial institutions in certain countries. Under these agreements, we have factored $216 million
and $217 million
of our accounts receivable as of June 30, 2026 and December 31, 2025, respectively. See Note 11 “Financial Instruments” to the Condensed Consolidated Financial Statements for information on our accounts receivable factoring and related agreements.
Net cash provided by operating activities was $332 million for the six months ended June 30, 2026, compared to $295 million for the same period in the prior year due to our active cash cycle management.
Net cash provided by investing activities was $310 million for the six months ended June 30, 2026, compared to $210 million used in investing activities for the same period in the prior year, primarily due to proceeds from the divestiture of the
Jada
system and decreased milestone payments.
Net cash used in financing activities was $50 million for the six months ended June 30, 2026, compared with $298 million for the same period in the prior year, primarily driven by decreased dividend payments and decreased repayments of debt in the current year.
As part of our post-spinoff plan to further optimize our manufacturing and supply network, we will continue to separate our supply chain through planned exits from supply agreements with Merck through 2031. This will enable us to redefine our appropriate sourcing strategy, and move to fit-for-purpose supply chains, while focusing on delivering efficiencies. We anticipate continuing to incur costs associated with this separation, including but not limited to accelerated depreciation, exit premiums and fees, technology transfer costs, stability and qualification batch costs, one-time resourcing costs, regulatory and filing costs, capital investment, and inventory stock bridges.
Our contractual obligations as of June 30, 2026, which require material cash requirements in the future, consist of contractual milestones, purchase obligations and lease obligations. Refer to “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2025 for further details. As of June 30, 2026, there have been no material changes to our contractual obligations outside of the ordinary course of business.
During the second quarter of 2026, we paid cash dividends of $0.02 per share. On July 31, 2026, the Board of Directors declared a quarterly dividend of $0.02 for each issued and outstanding share of our common stock. The dividend is payable on September 10, 2026, to stockholders of record at the close of business on August 14, 2026.
We or our affiliates may, at any time and from time to time, seek to retire or purchase our outstanding debt through cash purchases and/or exchanges for equity or debt, in open-market purchases, privately negotiated transactions or otherwise. Such transactions, if any, may be material, and will depend upon such terms and at such prices as we may determine, and will depend on prevailing market conditions, our liquidity requirements, contractual restrictions and other factors.
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Critical Accounting Estimates
Our significant accounting policies, which include management’s best estimates and judgments, are included in Note 2 “Summary of Accounting Policies” to the Consolidated Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2025. See Note 2 “Basis of Presentation” to the Condensed Consolidated Financial Statements for information on the adoption of new accounting standards during 2026. There have been no changes to our accounting policies as of June 30, 2026. A discussion of accounting estimates considered critical because of the potential for a significant impact on the Condensed Consolidated Financial Statements due to the inherent uncertainty in such estimates are disclosed in the Critical Accounting Estimates section of Management’s Discussion and Analysis of Financial Condition and Results of Operations included in Organon’s Annual Report on Form 10-K for the year ended December 31, 2025.
Recently Issued Accounting Standards
For a discussion of recently issued accounting standards, see Note 2 “Basis of Presentation” to the Condensed Consolidated Financial Statements included in this report.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
There have been no changes to our market risk during the quarter ended June 30, 2026. For a discussion of our exposure to market risk, refer to our market risk disclosures set forth under Item 7A.—Quantitative and Qualitative Disclosures About Market Risk in our Annual Report on Form 10-K for the year ended December 31, 2025.
Item 4. Controls and Procedures
Quarterly Evaluation of Disclosure Controls and Procedures
We have established disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Exchange Act) to provide reasonable assurance that information required to be disclosed in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer (“CEO”) (our principal executive officer) and Chief Financial Officer (“CFO”) (our principal financial officer), as appropriate to allow timely decisions regarding required disclosure, and ensure that information required to be disclosed in the reports we file or submit is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms.
Our management, with the participation of the CEO and the CFO, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2026 in connection with the filing of this report. Based on this evaluation, the CEO and the CFO concluded that our disclosure controls and procedures were effective as of June 30, 2026 at the reasonable assurance level.
Remediation of Material Weaknesses in Internal Control Over Financial Reporting
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.
As disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, we previously identified the following material weaknesses in our internal control over financial reporting.
•
We failed to set an appropriate tone at the top. Specifically, our former CEO and leader of our U.S. commercial organization applied inappropriate pressure to achieve sales targets through sales of
Nexplanon
to two United States wholesalers above demand and engaged in inappropriate business conduct that violated our Code of Conduct.
•
The material weakness with respect to our tone at the top contributed to an additional material weakness of not maintaining effective controls related to information and communication. We did not design and maintain effective controls related to the information and communication component of the framework in Internal Control — Integrated Framework issued in 2013 by the Committee of Sponsoring Organizations of the Treadway Commission. Specifically, our former CEO and certain senior members of our U.S. commercial organization did not ensure appropriate communication with, or provide complete information to, our Disclosure Committee and the financial reporting group to evaluate disclosures and financial reporting conclusions related to sales practices for wholesalers.
These material weaknesses did not result in misstatements of our previously reported historical financial statements. Each of these material weaknesses could have resulted in a misstatement of substantially all account balances or disclosures that could
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have resulted in a material misstatement to our annual or interim consolidated financial statements that would not have been prevented or detected.
During 2026, management executed upon its previously disclosed remediation plan to address the material weaknesses described above. We devoted substantial resources towards the implementation of enhanced procedures and controls and the remediation of material weaknesses in our internal control over financial reporting. We established a Remediation Plan Task Force to serve as a Project Management Office to monitor our remediation efforts and have also engaged external legal, accounting, financial and other consulting and professional services firms to assist in the development and execution of our comprehensive remediation plan. Actions taken include:
•
On October 27, 2025, our Board of Directors enacted Company leadership changes with the executive appointments of Joseph Morrissey as our Interim CEO and Carrie S. Cox as our Interim Executive Chair, with Mr. Morrissey and Ms. Cox being appointed to such roles on a permanent basis on April 26, 2026.
•
On October 27, 2025, Michael Casia was appointed as Interim Head of US Commercial and Government Affairs, with Mr. Casia being appointed to this role on a permanent basis on May 6, 2026.
•
Beginning in November 2025, we held multiple Founders meetings with employees, including Global Founders Forums and U.S. Commercial Town Hall. Senior leadership disseminated Company-wide and team-specific communications to emphasize our commitment to our core values, compliance, integrity and ethics.
•
On December 2, 2025, our Board of Directors ratified our enhanced Code of Conduct to clarify responsibilities related to our financial reporting and disclosures, including awareness of the options to raise concerns or questions to our management, human resources, compliance, legal, the technical accounting department and/or through the SpeakUp Tool, which is available globally as an alternate, confidential channel for raising concerns.
•
On January 30, 2026, we communicated and launched training on our Code of Conduct, as amended, regarding ethical tone, corporate culture and appropriate business practices.
•
During the quarter ended December 31, 2025, we implemented revisions to our Quarterly Financial Certification Questionnaire to include targeted questions that are designed to (i) address areas tied to the material weaknesses we identified in our internal control over financial reporting, (ii) strengthen our disclosures and (iii) reduce the risk of misleading business practices.
•
On February 2, 2026, our Audit Committee ratified an enhanced Disclosure Committee charter that was previously approved by our Interim CEO and CFO. These changes to the Disclosure Committee charter included, among other changes, (i) enumerating additional Disclosure Committee meeting requirements and guidelines for Disclosure Committee members and participants, (ii) providing for a Disclosure Committee Chair designated by the CEO and CFO, (iii) expanding the duties and responsibilities of the Disclosure Committee as to the type and scope of disclosure and risks for its review, (iv) requiring the Disclosure Committee to annually review its charter to identify any recommend changes and (v) mandating continuing education and training of the participants in our disclosure process. In addition, we strengthened our Disclosure Committee processes and procedures to facilitate active participation by Disclosure Committee members.
•
During the quarter ended December 31, 2025, we implemented additional and enhanced Sarbanes-Oxley (“SOX”) sub-certifications and internal management representation letters to support our public reporting and disclosure. By January 15, 2026, we provided training to our Executive Leadership Team and to other Disclosure Committee members and participants on the purpose and importance of SOX, SOX sub-certifications and the process for evaluating the representations made that support the disclosure contained in our filings.
•
On February 25, 2026, an enhancement to the Company’s Annual Ethics and Policy Certification was launched to all of our employees, requiring all founders to review and certify their understanding of ethical responsibilities and compliance with laws, regulations, and Organon policies, including our Code of Conduct.
•
On March 31, 2026, we communicated and launched training to relevant commercial and finance employees on revenue-related business practices, emphasizing the importance of revenue recognition and related disclosures. This training reinforced our commitment to ethical conduct, transparency, accuracy and reliability and helped to strengthen credibility and trust in our financial reporting.
•
We performed a comprehensive review of the quarterly Distribution Services Agreement payment process. Based on that review, we developed an internal policy to provide oversight and establish guidelines for management fee arrangements with wholesalers. This policy and related procedures were communicated to relevant U.S. Commercial employees on April 24, 2026.
•
New internal controls were implemented effective Q1 2026 related to US sales monitoring, as well as enhanced reviews for inventory levels at the wholesaler and days on hand at the wholesaler.
Our management completed testing of the implemented remediation actions described above during the quarter ended June 30, 2026, and found them to be operating effectively. As a result, management has concluded that the material weaknesses in internal control over financial reporting have been remediated as of June 30, 2026.
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Quarterly Changes in Internal Control Over Financial Reporting
There was no change in our internal control over financial reporting that occurred during the three months ended June 30, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
The information called for by this Item is incorporated herein by reference to Note 15 “Contingencies” to the Condensed Consolidated Financial Statements included in Part I, Item. 1.
Item 1A. Risk Factors
There have been no material changes in our risk factors from those disclosed in Item 1A. Risk Factors, in our Annual Report on Form 10-K for the year ended December 31, 2025 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026.
Item 5. Other Information
Rule 10b5-1 and Non-Rule 10b5-1 Trading Arrangements
During the three months ended June 30, 2026, none of our directors or officers
adopted
or
terminated
a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement, as each term is defined in Item 408(a) of Regulation S-K.
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Item 6. Exhibits
Number
Description
2.1
Agreement and Plan of Merger, dated as of April 26, 2026, by and among Organon & Co., Sun Pharmaceutical Holdings USA, Inc., Sun Pharma America, Inc. and, solely for the purposes of certain Covered Provisions of the Merger Agreement (as defined therein), Sun Pharmaceutical Industries Limited, Sun Pharma Canada Inc. and Sun Pharma (Netherlands) B.V. (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed on April 27, 2026).
*♦†10.1
Amendment No. 8 to Development and Commercialization Agreement, dated May 22, 2026, by and between Samsung Bioepsis Co., Ltd. and Organon LLC.
*♦†10.2
Amendment No. 9 to Development and Commercialization Agreement, dated May 26, 2026, by and between Samsung Bioepsis Co. Ltd. and Organon LLC.
*♦†10.3
Amendment No. 10 to Development and Commercialization Agreement, dated June 2, 2026, by and between Samsung Bioepsis Co., Ltd. and Organon LLC.
+10.4
Amended and Restated Organon & Co. 2021 Incentive Stock Plan (incorporated by reference to the Company’s Definitive Proxy Statement on Schedule 14A filed on April 24, 2026).
*31.1
—
Certification of Principal Executive Officer (CEO) pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
.
*31.2
—
Certification of Principal Financial Officer (CFO) pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
.
**32.1
—
Section 1350 Certification of Principal Executive Officer (CEO) pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
.
**32.2
—
Section 1350 Certification of Principal Financial Officer (CFO) pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
.
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
—
XBRL Taxonomy Extension Schema Document.
101.CAL
—
XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF
—
XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB
—
XBRL Taxonomy Extension Label Linkbase Document.
101.PRE
—
XBRL Taxonomy Extension Presentation Linkbase Document.
104
—
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
♦
Certain confidential information contained in portions of this exhibit, marked by [***] has been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K because such portions are (i) not material and (ii) are the type of information the registrant customarily and actually treats as private or confidential.
†
Certain schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant agrees to furnish a copy of any omitted schedule or exhibit to the SEC upon request; provided, however, that the registrant may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for any document so furnished.
+
Management contract or compensatory plan or arrangement.
*
Filed herewith.
**
Furnished herewith.
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Signatures
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
ORGANON & CO.
Date: July 31, 2026
/s/ Lynette Holzbaur
Lynette Holzbaur
Senior Vice President Finance - Corporate Controller
Date: July 31, 2026
/s/ Matthew Walsh
Matthew Walsh
Chief Financial Officer