ogn-20260930

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 September 30, 2026


☐			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 October 23, 2026: 262,621,584

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	37
Item 1.	Legal Proceedings	37
Item 1A.	Risk Factors	37
Item 5.	Other Information	37
Item 6.	Exhibits	38
	Signatures

The following notations in this Quarterly Report on Form 10-Q for the quarter ended September 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.

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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 September 30,				Nine Months Ended September 30,
	2026		2025		2026		2025
Revenues	$	1,574	$	1,602	$	4,592	$	4,709
Cost of sales	705		745		2,093		2,137
Gross profit	869		857		2,499		2,572

Selling, general and administrative	421		415		1,279		1,288
Research and development	83		84		266		275
Acquired in-process research and development and milestones	—		—		1		6

Restructuring costs	—		—		31		88
Interest expense	106		128		325		383
Exchange losses	6		17		15		12
Other income, net	(2)		(30)		(69)		(53)
Income before income taxes	255		243		651		573
Income tax expense	91		83		233		181


Net income	$	164	$	160	$	418	$	392

Earnings per share:


Basic	$	0.62	$	0.61	$	1.60	$	1.51




Diluted	$	0.60	$	0.61	$	1.56	$	1.50

Weighted average shares outstanding:
Basic	262,616		259,975		261,874		259,266
Diluted	272,384		260,653		268,585		260,611

The accompanying notes are an integral part of these interim Condensed Consolidated Financial Statements.

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Organon & Co.

Condensed Consolidated Statements of Comprehensive Income

(Unaudited, $ in millions)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2026		2025		2026		2025
Net income	$	164	$	160	$	418	$	392
Other Comprehensive Income (Loss), Net of Taxes:
Benefit plan net gain and prior service credit, net of amortization	—		—		1		—
Cumulative translation adjustment	9		(2)		(13)		75
Total other comprehensive income (loss), net of taxes	9		(2)		(12)		75
Comprehensive income	$	173	$	158	$	406	$	467

The accompanying notes are an integral part of these interim Condensed Consolidated Financial Statements.

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Organon & Co.

Condensed Consolidated Balance Sheets

(Unaudited, $ in millions except shares in thousands and per share amounts)


	September 30, 2026		December 31, 2025

Assets
Current Assets:
Cash and cash equivalents	$	1,455	$	574
Accounts receivable (net of allowance for doubtful accounts of $13 in 2026 and $12 in 2025)	1,480		1,331
Inventories (excludes inventories of $283 in 2026 and $236 in 2025 classified in Other assets)	1,355		1,406
Other current assets	1,079		1,033
Assets held for sale	—		8
Total Current Assets	5,369		4,352
Property, plant and equipment, net	1,286		1,303
Goodwill	4,153		4,153
Intangibles, net	1,065		1,130
Other assets	1,528		1,539
Noncurrent assets held for sale	—		390
Total Assets	$	13,401	$	12,867

Liabilities and Equity
Current Liabilities:
Current portion of long-term debt and short-term borrowings	$	69	$	16
Trade accounts payable	982		952
Accrued and other current liabilities	1,522		1,335
Income taxes payable	79		85
Liabilities held for sale	—		2
Total Current Liabilities	2,652		2,390
Long-term debt	8,485		8,628
Deferred income taxes	45		57
Other noncurrent liabilities	1,026		1,008
Noncurrent liabilities held for sale	—		32
Total Liabilities	12,208		12,115
Contingencies (Note 15)

Organon & Co. Stockholders’ Equity:
Common stock, $0.01 par value Authorized - 500,000 Issued and outstanding - 262,622 in 2026 and 260,316 in 2025	3		3
Additional paid-in capital	218		167
Retained earnings	1,511		1,109
Accumulated other comprehensive loss	(539)		(527)
Total Stockholders’ Equity	1,193		752
Total Liabilities and Stockholders’ Equity	$	13,401	$	12,867

The accompanying notes are an integral part of these interim Condensed Consolidated Financial Statements.

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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 July 1, 2025	259,965	$	3	$	139	$	1,163	$	(572)	$	733
Net income	—	—		—		160		—		160
Other comprehensive loss, net of taxes	—	—		—		—		(2)		(2)
Cash dividends declared on common stock ($0.02 per share)	—	—		—		(5)		—		(5)
Stock-based compensation plans and other	18	—		20		—		—		20
Balance at September 30, 2025	259,983	$	3	$	159	$	1,318	$	(574)	$	906

Balance at July 1, 2026	262,609	$	3	$	199	$	1,352	$	(548)	$	1,006
Net income	—	—		—		164		—		164
Other comprehensive income, net of taxes	—	—		—		—		9		9
Cash dividends declared on common stock ($0.02 per share)	—	—		—		(5)		—		(5)
Stock-based compensation plans and other	13	—		19		—		—		19
Balance at September 30, 2026	262,622	$	3	$	218	$	1,511	$	(539)	$	1,193









Balance at January 1, 2025	257,799	$	3	$	108	$	1,010	$	(649)	$	472
Net income	—	—		—		392		—		392
Other comprehensive income, net of taxes	—	—		—		—		75		75
Cash dividends declared on common stock ($0.32 per share)	—	—		—		(84)		—		(84)
Stock-based compensation plans and other	2,184	—		51		—		—		51
Balance at September 30, 2025	259,983	$	3	$	159	$	1,318	$	(574)	$	906

Balance at January 1, 2026	260,316	$	3	$	167	$	1,109	$	(527)	$	752
Net income	—	—		—		418		—		418
Other comprehensive loss, net of taxes	—	—		—		—		(12)		(12)
Cash dividends declared on common stock ($0.06 per share)	—	—		—		(16)		—		(16)
Stock-based compensation plans and other	2,306	—		51		—		—		51
Balance at September 30, 2026	262,622	$	3	$	218	$	1,511	$	(539)	$	1,193

The accompanying notes are an integral part of these interim Condensed Consolidated Financial Statements.

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Organon & Co.

Condensed Consolidated Statements of Cash Flows

(Unaudited, $ in millions)


	Nine Months Ended September 30,
	2026		2025
Cash Flows from Operating Activities
Net income	$	418	$	392
Adjustments to reconcile net income to net cash flows provided by operating activities:
Depreciation	107		110
Amortization	141		155
Impairment of assets	—		9
Acquired in-process research and development and milestones	1		6
Accretion and changes in fair value in contingent consideration	(6)		(9)
Deferred income tax expense	32		33
Stock-based compensation	65		70
Unrealized foreign exchange gain	(15)		(8)
Gain on sale of Jada	(81)		—
Gain on debt repurchase	—		(46)

Other	21		60
Net changes in assets and liabilities, net of assets acquired
Accounts receivable	(167)		(81)
Inventories	(36)		(94)
Other current assets	(36)		(54)
Trade accounts payable	39		(97)
Accrued and other current liabilities	191		14

Income taxes payable	(1)		(30)
Other	29		129
Net Cash Flows Provided by Operating Activities	702		559
Cash Flows from Investing Activities
Capital expenditures	(123)		(117)
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)		(124)
Net Cash Flows Provided by (Used in) Investing Activities	266		(325)
Cash Flows from Financing Activities
Proceeds from debt	—		730
Repayments of debt	(32)		(1,006)




Employee withholding taxes related to stock-based awards	(7)		(14)
Dividend payments	(16)		(84)
Net Cash Flows Used in Financing Activities	(55)		(374)





Effect of Exchange Rate Changes on Cash and Cash Equivalents	(32)		137

Net Increase (Decrease) in Cash and Cash Equivalents	881		(3)
Cash and Cash Equivalents, Beginning of Period	574		675



Cash and Cash Equivalents, End of Period	$	1,455	$	672

The accompanying notes are an integral part of these interim Condensed Consolidated Financial Statements.

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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 Jada 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), AybintioTM1 (bevacizumab), Bildyos® (denosumab-nxxp) and Bilprevda® (denosumab-nxxp) have been launched in more than 20 countries. Organon’s immunology biosimilars consist of: BrenzysTM1 (etanercept), Renflexis® (infliximab-abda), Hadlima® (adalimumab-bwwd) and Tofidence® (tocilizumab-bavi). Brenzys, Renflexis, and Hadlima have been launched in five countries. In 2025, Organon launched Bildyos injection 60 mg/mL and Bilprevda injection 120 mg/1.7 mL, biosimilars to Prolia2 (denosumab) and Xgeva2 (denosumab), respectively, in the United States. In 2025, Poherdy® (pertuzumab-dpzb) was approved by the U.S. Food and Drug Administration (“FDA”). The Company is assessing the timing of 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 by 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.

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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 420 mg/14 mL injection for intravenous use, the first and only approved biosimilar to Perjeta2 (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® copper intrauterine system, 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.

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Notes to Condensed Consolidated Financial Statements (unaudited)

Laborie Medical Technologies Corporation (“Laborie”)

In January 2026, the Company divested Jada 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 Jada of $81 million recognized in Other income, net in the Condensed Consolidated Statement of Income for the nine months ended September 30, 2026.

As part of the divestiture of Jada, the Company is eligible to receive potential contingent consideration of up to $25 million based on the achievement of certain net sales targets for Jada 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 Jada and the probability of various achievement scenarios for the sales targets. See Note 11. “Financial Instruments” for further information.

In connection with the divestiture of Jada, 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.

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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 September 30,				Nine Months Ended September 30,
($ in millions and shares in thousands, except per share amounts)	2026		2025		2026		2025



Net income	$	164	$	160	$	418	$	392

Basic weighted average number of shares outstanding	262,616		259,975		261,874		259,266
Stock awards and equity units (share equivalent)	9,768		678		6,711		1,345
Diluted weighted average common shares outstanding	272,384		260,653		268,585		260,611

EPS:


Basic	$	0.62	$	0.61	$	1.60	$	1.51




Diluted	$	0.60	$	0.61	$	1.56	$	1.50

Anti-dilutive shares excluded from the calculation of EPS	6,781		16,238		6,765		15,871

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.

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Notes to Condensed Consolidated Financial Statements (unaudited)

5. Product and Geographic Information

Revenues of the Company’s products were as follows:


	Three Months Ended September 30,												Nine Months Ended September 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	$	127	$	73	$	200	$	146	$	77	$	223	$	383	$	248	$	631	$	486	$	225	$	711
Follistim AQ	32		35		67		24		40		64		70		117		188		89		117		206
NuvaRing	6		19		25		9		17		26		20		56		76		21		54		75
Ganirelix Acetate Injection	4		21		24		3		19		22		7		69		76		10		67		77
Marvelon/Mercilon	—		28		28		—		31		31		—		85		85		—		103		103
Jada (3)	—		—		—		20		—		20		5		—		5		53		1		54
Other Women’s Health (1)	14		29		45		17		26		43		48		88		135		47		80		128
General Medicines
Biosimilars
Renflexis	46		21		67		51		19		70		133		57		190		141		49		190
Hadlima	62		24		86		47		16		63		168		64		231		116		44		159
Ontruzant	4		3		7		4		28		31		13		5		18		12		68		80
Brenzys	—		22		22		—		23		23		—		56		56		—		59		59
Bildyos/Bilprevda	17		7		24		3		—		3		37		23		60		3		—		3
Other Biosimilars (1)	10		2		13		3		3		6		25		7		32		6		13		19
Established Brands
Cardiovascular
Atozet	—		85		85		—		95		95		—		250		250		—		257		257
Zetia	1		100		101		1		91		93		4		280		284		4		248		252
Cozaar/Hyzaar	2		49		51		2		53		55		6		152		158		6		160		166
Vytorin	1		24		25		1		25		25		4		64		68		3		72		75
Rosuzet	—		5		5		—		6		6		—		16		16		—		16		16
Other Cardiovascular (1)	1		34		35		1		33		33		1		85		87		1		97		98
Respiratory
Singulair	2		43		45		2		51		53		6		127		132		6		187		193
Nasonex	—		65		65		—		60		60		—		188		188		—		197		197
Dulera	25		10		35		24		10		34		78		33		111		89		28		118
Clarinex	—		23		23		1		25		25		2		83		85		1		92		93
Other Respiratory (1)	11		3		14		9		2		12		38		5		44		32		9		40
Non-Opioid Pain, Bone and Dermatology
Arcoxia	—		69		69		—		71		71		—		197		197		—		195		195
Fosamax	1		28		28		—		40		40		2		80		82		2		106		107
Diprospan	—		42		42		—		41		41		—		121		121		—		112		112
Vtama	38		4		42		31		3		34		95		7		102		80		9		89
Other Non-Opioid Pain, Bone and Dermatology (1)	3		71		75		4		75		80		10		212		222		11		217		229
Other
Propecia	1		40		41		2		31		33		4		102		106		4		86		90
Emgality	—		59		59		—		51		51		—		166		166		—		125		125
Proscar	—		22		22		—		27		27		1		68		69		1		73		73
Other (1)	3		91		93		—		86		88		7		270		277		6		245		253
Other (2)	—		12		11		1		21		21		—		44		44		2		66		67
Revenues	$	411	$	1,163	$	1,574	$	406	$	1,196	$	1,602	$	1,167	$	3,425	$	4,592	$	1,232	$	3,477	$	4,709

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.

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Table of Contents

Notes to Condensed Consolidated Financial Statements (unaudited)

Revenues by geographic area where derived are as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
($ in millions)	2026		2025		2026		2025
Europe and Canada	$	417	$	417	$	1,262	$	1,212
United States	411		406		1,167		1,232
Asia Pacific and Japan	234		251		691		752
China	226		219		629		627
Latin America, Middle East, Russia, and Africa	269		286		785		810
Other (1)	17		23		58		76
Revenues	$	1,574	$	1,602	$	4,592	$	4,709

(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 September 30,				Nine Months Ended September 30,
($ in millions)	2026		2025		2026		2025
Stock-based compensation expense recognized in:
Cost of sales	$	4	$	4	$	11	$	12
Selling, general and administrative	14		16		43		46
Research and development	3		4		11		12
Total	$	21	$	24	$	65	$	70

Income tax benefits	$	5	$	5	$	14	$	15

The fair value of options granted was determined using the following assumptions:


	Nine Months Ended September 30,
	2025
Expected dividend yield(1)	7.41	%
Risk-free interest rate	4.08
Expected volatility	40.25
Expected life (years)(2)	5.89

(1) The expected dividend yield assumption is based on the Company's expected dividend payments at the grant date.

(2)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.

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Table of Contents

Notes to Condensed Consolidated Financial Statements (unaudited)

A summary of the equity award transactions for the nine months ended September 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	—	—		—		(3,543)	17.77		(193)	23.20
Forfeited/Cancelled	(2,299)	30.78		8.11		(1,623)	9.15		(140)	23.20
Outstanding as of September 30, 2026	5,220	$	25.76	$	6.50	18,135	$	8.44	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 September 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	5,146	$	25.76	$	—	5.98	3,949	$	29.00	$	—	5.24
RSUs	16,759			249		2.00
PSUs	2,436			38		2.04

The amount of unrecognized compensation costs as of September 30, 2026 was $136 million, which will be recognized in operating expense ratably over the weighted average vesting period of 1.97 years.

7. Restructuring

During the first quarter of 2026, the Company implemented restructuring initiatives that resulted 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:


	September 30, 2026		December 31, 2025
Beginning balance	$	8	$	14
Severance & severance related costs	31		95
Cash payments and other	(37)		(101)
Ending balance	$	2	$	8

Organon expects the remaining severance payments associated with the restructuring activities to be paid within the next twelve months.

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Table of Contents

Notes to Condensed Consolidated Financial Statements (unaudited)

8. Taxes on Income

The effective income tax rates were 35.7% and 34.0% for the three months ended September 30, 2026 and 2025, respectively, and 35.8% and 31.6% for the nine months ended September 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 nine month tax rate is the beneficial impact of the sale of Jada. 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)	September 30, 2026		December 31, 2025
Finished goods	$	702	$	751
Raw materials	12		14
Work in process	843		791
Supplies	79		81
Total (approximates current cost)	$	1,636	$	1,637
Increase to last in, first out (“LIFO”) costs	2		5
Total inventories	$	1,638	$	1,642

Recognized as:
Inventories	$	1,355	$	1,406
Other assets	283		236

Inventories valued under the LIFO method	131		114

In connection with the divestiture of Jada 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 Sciences Ltd. (“Dermavant”) acquisition in 2024, the Company acquired $97 million of inventory, which included a $63 million purchase accounting inventory fair value adjustment. As of September 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.

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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)	September 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)	804		843

4.125% secured notes due 2028	2,100		2,100
2.875% euro-denominated secured notes due 2028 (€1.25 billion)	1,422		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)	183		179
Other borrowings	8		8
Other (discounts and debt issuance costs)	(67)		(81)
Total principal long-term debt and short-term borrowings	$	8,554	$	8,644
Less: Current portion of long-term debt and short-term borrowings	69		16
Total Long-term debt, net of current portion	$	8,485	$	8,628

(1) Recognized at the amortized cost basis. The remaining principal is determined as the initial fair value less principal payments. As of September 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 divestiture of Jada 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 divestiture of Jada.

For the nine months ended September 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 September 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	September 30, 2026		December 31, 2025
Long-term debt	2	$	8,404	$	7,922
Long-term debt - RIPSA	3	141		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 $244 million for the nine months ended September 30, 2026. The average maturity of the Company’s long-term debt as of September 30, 2026 is approximately 3.8 years and the weighted-average interest rate on total borrowings as of September 30, 2026 is 5.0%.

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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 $27 million of accrued interest related to the RIPSA, and thereafter are as follows:


($ in millions)
2026	$	1
2027	61
2028	3,483
2029	9
2030	22
Thereafter	5,018

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 September 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	September 30, 2026		December 31, 2025
Other current assets:
Forward contracts	2	$	12	$	12
Contingent consideration(a)	3	5		—


Accrued and other current liabilities:

Forward contracts	2	22		11
Other noncurrent liabilities:
Contingent consideration	3	263		269
Cross-currency swap	2	44		82

(a) As part of the divestiture of Jada in January 2026, the Company is eligible to receive potential contingent consideration based on the achievement of certain net sales targets for Jada 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.

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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 in the Condensed Consolidated Statements of Income. The forward contracts are not designated as hedges and are marked to market through Exchange losses 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 $1.7 billion as of September 30, 2026 and December 31, 2025. 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 September 30,				Nine Months Ended September 30,
($ in millions)	2026		2025		2026		2025
Euro-denominated debt instruments gain (loss)	$	5	$	5	$	76	$	(244)
Cross-currency swaps gain (loss)	14		14		38		(115)

The Condensed Consolidated Statements of Income include the impact of net (gains) losses of Organon’s derivative financial instruments:


	Three Months Ended September 30,				Nine Months Ended September 30,
($ in millions)	2026		2025		2026		2025
Derivative loss (gain) in Exchange losses	$	12	$	7	$	37	$	(12)
Derivative gain in Interest expense	(3)		(3)		(8)		(8)

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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 September 30, 2026, the fair value measurements of acquisition-related contingent consideration were determined using discount rates ranging from 6.74% to 7.40%.

The following table presents a reconciliation of contingent consideration measured on a recurring basis using significant unobservable inputs (Level 3):


($ in millions)	September 30, 2026
Beginning balance	$	269


Accretion and changes in fair value in Other income, net	(6)

Ending balance	$	263

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 September 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 $212 million and $217 million of accounts receivable as of September 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 nine months ended September 30, 2026 and 2025.

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Table of Contents

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 (Loss) Income
Balance at July 1, 2025, net of taxes	$	(17)	$	(555)	$	(572)
Other comprehensive loss, pretax	—		(2)		(2)
Tax	—		—		—
Other comprehensive loss, net of taxes	—		(2)		(2)
Balance at September 30, 2025, net of taxes	$	(17)	$	(557)	$	(574)

Balance at July 1, 2026, net of taxes	$	5	$	(553)	$	(548)
Other comprehensive income, pretax	—		9		9
Tax	—		—		—
Other comprehensive income, net of taxes	—		9		9
Balance at September 30, 2026, net of taxes	$	5	$	(544)	$	(539)








Balance at January 1, 2025, net of taxes	$	(17)	$	(632)	$	(649)
Other comprehensive income, pretax	—		75		75
Tax	—		—		—
Other comprehensive income, net of taxes	—		75		75
Balance at September 30, 2025, net of taxes	$	(17)	$	(557)	$	(574)

Balance at January 1, 2026, net of taxes	$	4	$	(531)	$	(527)
Other comprehensive income (loss), pretax	1		(13)		(12)
Tax	—		—		—
Other comprehensive income (loss), net of taxes	1		(13)		(12)
Balance at September 30, 2026, net of taxes	$	5	$	(544)	$	(539)

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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Table of Contents

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”).

On September 11, 2026, the Samsung Agreement was amended to include additional dosage forms of Pyzchiva® in Canada (“Amendment No. 11”).

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 September 30,				Nine Months Ended September 30,
($ in millions)	2026		2025		2026		2025
Sales	$	185	$	190	$	503	$	501
Cost of sales	119		120		310		312
Selling, general and administrative	18		17		54		55


($ in millions)	September 30, 2026		December 31, 2025

Payables to Samsung included in Trade accounts payable	$	188	$	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 September 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)	September 30, 2026		December 31, 2025
Due from Merck in Accounts receivable	$	105	$	98
Due to Merck in Accounts payable	303		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 September 30,				Nine Months Ended September 30,
($ in millions)	2026		2025		2026		2025
Sales	$	11	$	18	$	37	$	55
Cost of sales	12		15		33		47

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 September 30, 2026, the Fosamax Litigation consisted of 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, 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, non-material settlement payment, 56 plaintiffs and claimants will release the defendant parties from any liability for their filed and unfiled claims. As of September 30, 2026, Merck had 18 of such cases pending outside the United States, of which six 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. On July 17, 2026, the Lead Plaintiff filed its motion for leave to file a second amended complaint. The Company filed a motion in opposition to the Lead Plaintiff’s motion on August 17, 2026 and the Lead Plaintiff filed its reply to this opposing motion on September 10, 2026.

The conduct alleged in the individual securities complaints also forms the basis of two stockholder derivative lawsuits filed on June 11, 2025 and June 17, 2025, respectively, 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 these two 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. On September 19, 2026, a third stockholder derivative suit was filed which contained allegations similar to those raised in the first amended complaint in the securities lawsuit.

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.

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Notes to Condensed Consolidated Financial Statements (unaudited)

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”). 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 (“ANDAs”) 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 ANDA with 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”) filed an ANDA with 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 September 1, 2026, the Company filed a complaint against Encube in the U.S. District Court for the District of Delaware asserting that the filing of the ANDA infringed the patents that were the subject of the Paragraph IV Certification and triggering a stay of regulatory approval of Encube’s ANDA for up to 30 months.

On July 23, 2026, Organon received a Paragraph IV Certification Letter under the Hatch-Waxman Act notifying the Company that Mylan Pharmaceuticals, Inc. (“Mylan”) filed an ANDA with 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 August 31, 2026, the Company filed a complaint against Mylan in the U.S. District Court for the Northern District of West Virginia asserting that the filing of the ANDA infringed the patents that were the subject of the Paragraph IV Certification and triggering a stay of regulatory approval of Mylan’s ANDA for up to 30 months.

On July 27, 2026, Organon received a Paragraph IV Certification Letter under the Hatch-Waxman Act notifying the Company that Natco Pharma Limited (“Natco”) filed an ANDA with 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. On September 8, 2026, the Company filed a complaint against Natco in the U.S. District Court for the District of New Jersey asserting that the filing of the ANDA infringed the patents that were the subject of the Paragraph IV Certification and triggering a stay of regulatory approval of Natco’s ANDA for up to 30 months.

On August 4, 2026, Organon received a Paragraph IV Certification Letter under the Hatch-Waxman Act notifying the Company that Dr. Reddy’s Laboratories Limited (“DRL”) filed an ANDA with the FDA seeking approval to market a generic version of Vtama. DRL’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 September 3, 2026, the Company filed a complaint against DRL in the U.S.

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Notes to Condensed Consolidated Financial Statements (unaudited)

District Court for the District of New Jersey asserting that the filing of the ANDA infringed the patents that were the subject of the Paragraph IV Certification and triggering a stay of regulatory approval of DRL’s ANDA for up to 30 months.

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 September 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.

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 September 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 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 remaining 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; the possibility that competing offers or acquisition proposals for Organon will be made; 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, including any resulting disruptions to manufacturing supply chains, distribution networks, logistics providers, raw material sourcing, or transportation; 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; our ability to refinance or repay indebtedness maturing in 2028 if the proposed transaction is not completed, and the resulting impact on our liquidity, financial condition and ability to continue as a going concern; 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; manufacturing performance issues at Company-owned and third-party facilities, operational disruptions, labor-related disruptions, or geopolitical events that affect the manufacture, supply, distribution, or availability of our products, the increased cost of supply, manufacturing, packaging, and operations, including as a result of volatility in commodity prices, fuel costs and shipping rates; 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; 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, governmental agency staffing, operations and enforcement priorities, 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

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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 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; 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 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 by 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 was launched in Canada in the third quarter of 2026.

In connection with Amendment No. 9, we are required to make fixed payments totaling $30 million over a nine-year period from 2026 through 2034. We 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.

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 we 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 first half of 2027.

On September 11, 2026, the Samsung Agreement was amended to include additional dosage forms of Pyzchiva in Canada (“Amendment No. 11”).

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 commercial 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, we recognized an intangible asset of $27.5 million.

Laborie Medical Technologies Corporation (“Laborie”)

In January 2026, we divested Jada 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 Jada of $81 million recognized in Other income, net in the Condensed Consolidated Statement of Income for the nine months ended September 30, 2026.

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Operating Results

Sales Overview


	Three Months Ended September 30,				% Change		% Change Excluding Foreign Exchange		Nine Months Ended September 30,				% Change	% Change Excluding Foreign Exchange
($ in millions)	2026		2025						2026		2025
United States	$	411	$	406	1	%	1	%	$	1,167	$	1,232		(5)	%	(5)	%
International	1,163		1,196		(3)		(4)		3,425		3,477			(1)		(5)
Total	$	1,574	$	1,602	(2)	%	(3)	%	$	4,592	$	4,709		(2)	%	(5)	%

Worldwide sales were $1.6 billion for the three months ended September 30, 2026, a decrease of 2%, compared to 2025. Worldwide sales were positively impacted by approximately $12 million or 1%, due to favorable foreign exchange rates.

Excluding the impact of foreign exchange rates, sales decreases for the three months ended September 30, 2026 primarily reflect lower sales of:

•Ontruzant, due to lower tendered volume from Brazil’s Ministry of Health when compared with the same period in 2025;

•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;

•Jada, due to no longer having sales following the divestiture of Jada to Laborie in January 2026; and

•certain Established Brands products within international markets, due to temporary supply chain and operational disruptions affecting availability.

This performance was offset by sales increases for the three months ended September 30, 2026 in:

•Hadlima, due to stronger demand in the United States and Puerto Rico;

•Bildyos/Bilprevda, as a result of the product launch in the third quarter of 2025; and

•Emgality, as a result of increased demand in various international markets.

Worldwide sales were $4.6 billion for the nine months ended September 30, 2026, a decrease of 2%, compared to 2025. Worldwide sales during the nine months ended September 30, 2026 were positively impacted by approximately $130 million, or approximately 3%, due to favorable foreign exchange rates.

Excluding the impact of foreign exchange rates, sales decreases for the nine months ended September 30, 2026, primarily reflect 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), primarily attributable to decreased demand due to less favorable medical guidelines in certain international markets, most recently in China, and mandatory price reductions in China and Japan; and

•certain Established Brands products within international markets, due to temporary supply chain and operational disruptions affecting availability.

This performance was offset by sales increases for the nine months ended September 30, 2026 in:

•Hadlima, due to stronger demand in the United States and Puerto Rico;

•Bildyos/Bilprevda, as a result of the product launch in the third quarter of 2025; and

•Emgality, as a result of increased demand in various international markets.

Loss of exclusivity (“LOE”) negatively impacted sales of certain of our products by approximately $13 million and $23 million during the three and nine months ended September 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 $8 million and $15 million during the three and nine months ended September 30, 2026, respectively. We expect VBP to continue to negatively impact our general medicines product portfolio for the next several quarters.

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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 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 nine months ended September 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 September 30,				% Change		% Change Excluding Foreign Exchange		Nine Months Ended September 30,				% Change	% Change Excluding Foreign Exchange
($ in millions)	2026		2025						2026		2025
Nexplanon/Implanon NXT	$	200	$	223	(10)	%	(11)	%	$	631	$	711		(11)	%	(13)	%
NuvaRing	25		26		(2)		(2)		76		75			1		(4)
Marvelon/Mercilon	28		31		(10)		(9)		85		103			(17)		(18)
Follistim AQ	67		64		6		5		188		206			(9)		(11)
Jada	—		20		(100)		(100)		5		54			(90)		(90)

Contraception

Worldwide sales of Nexplanon, a single-rod subdermal contraceptive implant, declined 10% and 11% for the three and nine months ended September 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. 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 for the nine months ended September 30, 2026 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 2% for the three months ended September 30, 2026, compared to 2025, due to decreased demand in various international markets. Sales of NuvaRing, increased 1% for the nine months ended September 30, 2026, compared to 2025, due to the favorable impact of foreign exchange 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 10% and 17% for the three and nine months ended September 30, 2026, compared to 2025, respectively, as a result of decreased demand and market contraction in China.

Fertility

Worldwide sales of Follistim AQ, a fertility treatment, increased 6% for the three months ended September 30, 2026, compared to 2025, as a result of increased demand and favorable discount rates in the United States, partially offset by decreased demand in China. Sales of Follistim AQ, declined 9% for the nine months ended September 30, 2026, compared to 2025, as a result of competitive pricing pressures in the United States and decreased demand in China partially offset by increased demand and favorable discount rates in the United States.

Other Women’s Health

In January 2026, we completed the sale of Jada to Laborie and, thereafter, no longer actively sold Jada. As a result, worldwide sales of Jada significantly declined for the three and nine months ended September 30, 2026, compared to 2025, respectively.

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General Medicines

Biosimilars


	Three Months Ended September 30,				% Change		% Change Excluding Foreign Exchange		Nine Months Ended September 30,				% Change	% Change Excluding Foreign Exchange
($ in millions)	2026		2025						2026		2025
Renflexis	$	67	$	70	(5)	%	(5)	%	$	190	$	190		—	%	(1)	%
Hadlima	86		63		35		35		231		159			45		45
Ontruzant	7		31		(77)		(77)		18		80			(77)		(77)
Brenzys	22		23		(5)		(6)		56		59			(5)		(8)
Bildyos/Bilprevda	24		3		*		*		60		3			*		*

* Calculation not meaningful.

Renflexis is a biosimilar to Remicade2 (infliximab) for the treatment of certain autoimmune conditions. Sales declined 5% and remained consistent for the three and nine months ended September 30, 2026, compared to 2025, respectively, primarily due to competitive pressure and unfavorable discount rates in the United States, partially offset by increased demand in Canada.

Hadlima is a biosimilar to Humira2 (adalimumab) for the treatment of certain autoimmune and autoinflammatory conditions. Sales increased 35% and 45% for the three and nine months ended September 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 Herceptin2 (trastuzumab) for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Sales for the three and nine months ended September 30, 2026, compared to 2025, declined 77%, due to lower tendered volume from Brazil’s Ministry of Health when compared with the same periods in 2025. We have commercialization rights to Ontruzant in all countries except in South Korea and China.

Brenzys is a biosimilar to Enbrel2 (etanercept) for the treatment of certain inflammatory diseases. Sales for the three and nine months ended September 30, 2026, compared to 2025, declined 5%, as a result of the timing of shipments in Brazil and decreased demand in the Asia Pacific region. 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 $24 million and $60 million for the three and nine months ended September 30, 2026, respectively, as a result of the product launch in the third quarter of 2025.

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Established Brands

International revenue during the period was partially constrained by various supply-related challenges affecting the Company's ability to fully meet customer demand, primarily for certain of our Established Brands products. While some of these challenges surfaced in prior periods, the current period had compounding constraints across the supply chains and resulted in an unfavorable impact estimated to be approximately less than 2% to the Company’s consolidated revenue for the three and nine months ended September 30, 2026. These challenges included the impact of manufacturing disruptions at a key contract manufacturer, temporary operational constraints at certain facilities, labor-related disruptions at a third-party logistics provider, and geopolitical disruptions (the “Supply Constraints”). Management continues to implement mitigation strategies designed to improve production and supplier reliability, strengthen supply chain resilience, and support future demand. While certain of these challenges have been resolved, full recovery of the supply chains remain on-going.

Cardiovascular


	Three Months Ended September 30,				% Change		% Change Excluding Foreign Exchange		Nine Months Ended September 30,				% Change	% Change Excluding Foreign Exchange
($ in millions)	2026		2025						2026		2025
Atozet	$	85	$	95	(10)	%	(10)	%	$	250	$	257		(3)	%	(5)	%
Zetia/Vytorin	126		118		7		5		352		327			8		4
Cozaar/Hyzaar	51		55		(8)		(10)		158		166			(5)		(8)

Sales of Atozet™¹ (ezetimibe and atorvastatin), a medicine for lowering LDL cholesterol, decreased 10% and 3% for the three and nine months ended September 30, 2026, compared to 2025, due to unfavorable pricing in Europe and the impact of the Supply Constraints, partially offset by increased demand in Korea and China.

Combined global sales of Zetia® (ezetimibe), which is marketed as Ezetrol™ in most countries outside the United States; and of Vytorin® (ezetimibe / simvastatin), which is marketed as Inegy™ outside the United States, which are medicines for lowering LDL cholesterol, increased 7% and 8% for the three and nine months ended September 30, 2026, compared to 2025, respectively, primarily driven by increased demand in China partially offset by the impact of the Supply Constraints.

Combined global sales of Cozaar® (losartan) and Hyzaar® (losartan / hydrochlorothiazide), which are medicines for the treatment of hypertension, declined 8% and 5% for the three and nine months ended September 30, 2026, compared to 2025, respectively, driven by decreased demand in various international markets.

Respiratory


	Three Months Ended September 30,				% Change		% Change Excluding Foreign Exchange		Nine Months Ended September 30,				% Change	% Change Excluding Foreign Exchange
($ in millions)	2026		2025						2026		2025
Singulair	$	45	$	53	(15)	%	(15)	%	$	132	$	193		(31)	%	(32)	%
Nasonex	65		60		8		6		188		197			(5)		(10)
Dulera	35		34		5		5		111		118			(6)		(6)

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 15% and 31% for the three and nine months ended September 30, 2026, compared to 2025, respectively, primarily attributable to decreased demand due to less favorable medical guidelines in certain international markets, most recently in China, and price reductions in China and Japan.

Global sales of Nasonex® (mometasone furoate), an inhaled nasal corticosteroid for the treatment of nasal allergy symptoms, increased 8% for the three months ended September 30, 2026, compared to 2025, due to increased demand in China, offset by competitive pressure in various international markets. Sales of Nasonex declined 5% for the nine months ended September 30, 2026, compared to 2025, due to competitive pressure in various international markets and the impact of the Supply Constraints, partially offset by increased demand in China.

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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 5% for the three months ended September 30, 2026, compared to 2025, primarily due to recovery from the impact of the Supply Constraints that occurred in the third quarter of 2025. Global sales of Dulera declined 6% for the nine months ended September 30, 2026, compared to 2025, primarily due to decreased demand in the United States.

Non-Opioid Pain, Bone and Dermatology


	Three Months Ended September 30,				% Change		% Change Excluding Foreign Exchange		Nine Months Ended September 30,				% Change	% Change Excluding Foreign Exchange
($ in millions)	2026		2025						2026		2025
Arcoxia	$	69	$	71	(3)	%	(4)	%	$	197	$	195		1	%	(4)	%
Vtama	42		34		21	%	21	%	102		89			15	%	15	%

Sales of Arcoxia™ ¹ (etoricoxib), a medicine for the treatment of arthritis and pain, decreased 3% for the three months ended September 30, 2026, compared to 2025, due to the impact of the Supply Constraints and decreased demand in Mexico. Sales of Arcoxia increased 1% for the nine months ended September 30, 2026, compared to 2025, due to the impact of foreign exchange partially offset by the impact of the Supply Constraints and decreased demand in Mexico.

Sales of Vtama, a cream for the topical treatment of plaque psoriasis and atopic dermatitis, also known as eczema, increased 21% and 15% for the three and nine months ended September 30, 2026, compared to 2025, respectively, due to increased demand and favorable discount rates in the United States, partially offset by the reduced 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 September 30,				% Change	% Change Excluding Foreign Exchange	Nine Months Ended September 30,				% Change	% Change Excluding Foreign Exchange
($ in millions)	2026		2025				2026		2025
Emgality	$	59	$	51	16%	16	$	166	$	125		33	%	26	%

Sales of Emgality, a medicine for the preventive treatment of migraine, increased 16% and 33% for the three and nine months ended September 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 September 30,				% Change		Nine Months Ended September 30,				% Change
($ in millions)	2026		2025				2026		2025
Cost of sales	$	705	$	745	(5)	%	$	2,093	$	2,137		(2)	%
Gross profit	869		857		1		2,499		2,572			(3)

Selling, general and administrative	421		415		1		1,279		1,288			(1)
Research and development	83		84		(1)		266		275			(3)
Acquired in-process research and development and milestones	—		—		*		1		6			(83)

Restructuring costs	—		—		*		31		88			(65)
Interest expense	106		128		(17)		325		383			(15)
Exchange losses	6		17		(65)		15		12			25
Other income, net	(2)		(30)		(93)		(69)		(53)			30

* Calculation not meaningful.

Cost of Sales

Cost of sales decreased 5% and 2% for the three and nine months ended September 30, 2026, compared to 2025, respectively, driven by our product mix and the impact of foreign exchange. Cost of sales for the three and nine months ended September 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 $48 million and $141 million, respectively. Cost of sales for the three and nine months ended September 30, 2025 includes amortization associated with the inventory fair value adjustment related to the Dermavant acquisition of $12 million and $31 million, respectively, an impairment charge in the nine months ended September 30, 2025 related to a currently marketed women’s health product of $9 million and amortization of intangible assets of $52 million and $155 million, respectively.

Gross Profit

Gross profit increased 1% for the three months ended September 30, 2026, compared to 2025, due to the impact of favorable changes in net pricing and foreign exchange, offset by unfavorable volume and product mix. Gross profit decreased 3% for the nine months ended September 30, 2026 compared to 2025 due to the impact of unfavorable volume, pricing and product mix and unfavorable foreign exchange.

Selling, General and Administrative

Selling, general and administrative expenses increased 1% for the three months ended September 30, 2026 compared to 2025, due to increased costs associated with the pending transaction with Sun Pharma, offset by reduced headcount-related costs and lower spending as part of our ongoing cost-saving and restructuring initiatives. Selling, general and administrative expenses decreased 1% for the nine months ended September 30, 2026 compared to 2025, due to reduced headcount-related costs and lower spending as part of our ongoing cost-saving and restructuring initiatives partially offset by increased costs associated with the pending transaction with Sun Pharma.

Research and Development

Research and development expenses decreased 1% and 3% for each of the three and nine months ended September 30, 2026 compared to 2025, respectively, 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 nine months ended September 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 nine months ended September 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 nine months ended September 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 17% and 15% for the three and nine months ended September 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

Exchange losses were favorable for the three months ended September 30, 2026 and unfavorable for the nine months ended September 30, 2026, compared to 2025. This was primarily due to movements in certain foreign currencies relative to the U.S. dollar.

Other Income, net

Other income, net was impacted for the three months ended September 30, 2026 by $10 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 income, net was impacted for the nine months ended September 30, 2026 by an $81 million net gain related to the divestiture of Jada to Laborie in the first quarter of 2026, $6 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 offset by $17 million due to an unfavorable resolution of a working capital matter related to the Dermavant acquisition.

Taxes on Income

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 September 30, 2026, we had cash and cash equivalents of $1.46 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 $2.72 billion and $1.96 billion as of September 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 Jada.

We have accounts receivable factoring agreements with financial institutions in certain countries. Under these agreements, we have factored $212 million and $217 million of our accounts receivable as of September 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 $702 million for the nine months ended September 30, 2026, compared to $559 million for the same period in the prior year due to our active cash cycle management.

Net cash provided by investing activities was $266 million for the nine months ended September 30, 2026, compared to $325 million used in investing activities for the same period in the prior year, primarily due to proceeds from the divestiture of Jada and decreased milestone payments in the current year.

Net cash used in financing activities was $55 million for the nine months ended September 30, 2026, compared with $374 million for the same period in the prior year, primarily driven by decreased repayments of debt in the current year and decreased dividend payments.

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 September 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 September 30, 2026, there have been no material changes to our contractual obligations outside of the ordinary course of business.

During the third quarter of 2026, we paid cash dividends of $0.02 per share. On October 30, 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 December 10, 2026, to stockholders of record at the close of business on November 9, 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 September 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 September 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

Our management, with the participation of our Chief Executive Officer (“CEO”) (our principal executive officer) and Chief Financial Officer (“CFO”) (our principal financial officer), evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act of 1934, as amended (the “Exchange Act”)) as of September 30, 2026. Based upon that evaluation, our CEO and our CFO concluded that, as of September 30, 2026, the end of the period covered by this report, our disclosure controls and procedures were effective and provide reasonable assurance that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the applicable rules and forms, and that it is accumulated and communicated to our management, including our CEO and our CFO, as appropriate, to allow timely decisions regarding required disclosure.

During the quarter ended September 30, 2026, there were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that materially affected, or are 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 September 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


	*♦†10.1	—	Amendment No. 11 to the Development and Commercialization Agreement, dated September 11, 2026, by and between Samsung Bioepis Co., Ltd. and Organon LLC.
	*+10.2	—	Organon Executive Change in Control Severance Program, as amended and restated on April 15, 2025, as further amended on August 14 , 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 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: October 30, 2026						/s/ Lynette Holzbaur
						Lynette Holzbaur
						Senior Vice President Finance - Corporate Controller

Date: October 30, 2026						/s/ Matthew Walsh
						Matthew Walsh
						Chief Financial Officer