Organon Reports Results for the Fourth Quarter and Full Year Ended December 31, 2025

Key Terms

non-gaap adjusted gross margin financial

Non-GAAP adjusted gross margin is the percentage of sales left after direct product or service costs, but recalculated after removing certain one-time or non-cash items that management believes obscure underlying profitability. Think of it as a cleaned-up version of the basic profit-on-sales number that aims to show how efficiently a company makes its product when you wipe away unusual or accounting-driven smudges. Investors use it to judge core operating performance, but it can vary by company and may omit real costs, so compare adjustments carefully.

adjusted ebitda financial

Adjusted EBITDA is a way companies measure how much money they make from their core operations, like running a business, by removing certain costs or income that aren’t part of regular business activities. It helps investors see how well a company is doing without distractions from unusual expenses or gains, making it easier to compare companies or track performance over time.

goodwill impairment financial

Goodwill impairment occurs when a company’s valued reputation or brand strength, known as goodwill, is found to be worth less than previously recorded on its financial statements. This usually happens when the company's performance declines or market conditions change, signaling that the expected benefits from acquisitions or brand value are no longer as strong. It matters to investors because it can indicate that a company's assets are less valuable than initially thought, potentially affecting its overall financial health.

form 8-k regulatory

A Form 8-K is a report that companies file with the government to share important news quickly, such as changes in leadership, major business deals, or financial updates. It matters because it helps investors stay informed about significant events that could affect the company's value or stock price.

form 10-k regulatory

A Form 10-K is a comprehensive report that publicly traded companies are required to file annually with regulators. It provides a detailed overview of a company's financial health, operations, and risks, similar to a detailed health report. Investors use this information to assess the company's performance and make informed decisions about buying or selling its stock.

audit committee regulatory

A company's audit committee is a small group of board members who act like independent inspectors for the firm's finances, overseeing how financial reports are prepared, monitoring internal controls, and managing the relationship with external auditors. Investors care because a strong audit committee reduces the risk of accounting errors, fraud, or misleading statements, making financial statements more trustworthy and helping protect shareholder value.

u.s. food and drug administration regulatory

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

fx financial

fx stands for foreign exchange, the system of buying, selling and converting one currency into another. For investors, fx matters because changes in exchange rates can raise or lower a company’s reported sales, costs and profits when business crosses borders—like how the same amount of money can buy more or less abroad—so movements in fx can affect earnings, valuation and investment returns.

• Full year 2025 revenue of $6.2 billion, down 3% on both an as-reported basis and at constant currency
• Full year 2025 diluted earnings per share of $0.72 and non-GAAP Adjusted diluted earnings per share of $3.66
• Full year 2025 Adjusted EBITDA of $1.91 billion inclusive of $6 million of IPR&D, representing a 30.7% Adjusted EBITDA margin
• The company expects to deliver approximately $6.2 billion of revenue and approximately $1.9 billion of Adjusted EBITDA for the full year 2026, both measures in-line with full year 2025 performance.

JERSEY CITY, N.J.--(BUSINESS WIRE)-- Organon (NYSE: OGN) today announced its results for the fourth quarter and full year ended December 31, 2025.

“In 2025 we took action that demonstrated our commitment to improving the balance sheet and to building more financial flexibility,” said Joe Morrissey, Organon’s interim Chief Executive Officer. “In 2026 our primary objective is to maintain operational performance that aligns with last year. At the same time, we remain committed to disciplined expense management and capital deployment to achieve progress on our deleveraging efforts.”

Fourth Quarter 2025 Revenue

in $ millions		Q4 2025			Q4 2024			VPY		VPY ex-FX
Women’s Health		$	398		$	466		(15)%		(16)%
General Medicines
Biosimilars			181			163		11%		11%
Established Brands			913			935		(2)%		(5)%
Other (1)			15			28		(48)%		(49)%
Revenue		$	1,507		$	1,592		(5)%		(8)%
Totals may not foot due to rounding and percentages are computed using unrounded amounts.
(1) Other includes manufacturing sales to third parties.

For the fourth quarter of 2025, total revenue was $1.507 billion, down 5% on an as-reported basis and down 8% excluding the impact of foreign currency (ex-FX), compared with the fourth quarter of 2024.

Women’s Health revenue declined 15% as-reported and declined 16% ex-FX in the fourth quarter of 2025, compared with the fourth quarter of 2024. Sales of Nexplanon® (etonogestrel implant) decreased 20% ex-FX in the fourth quarter compared with the prior year period primarily due to: an approximate $17 million decrease in sales due to the cessation of certain identified U.S. wholesaler sales practices described in the company’s Form 8-K filed with the U.S. Securities and Exchange Commission on October 27, 2025; lower U.S. demand mainly associated with policy-related access restrictions and a reduction in physician demand in certain commercial segments; and an increase in the rebate rate in the U.S. attributable to patient mix. The company’s fertility business declined 6% ex-FX in the fourth quarter of 2025 which is primarily related to sales performance in China, where socio-economic trends continue to weigh on the broader fertility market.

Biosimilars revenue increased 11% on both an as-reported basis and ex-FX in the fourth quarter of 2025, compared with the fourth quarter of 2024, primarily due to strong performance of Hadlima® (adalimumab-bwwd). To a lesser extent, during the fourth quarter the Biosimilars portfolio also benefitted from contribution from new assets; Bildyos® (denosumab-nxxp) and Bilprevda® (denosumab-nxxp), which were approved by the U.S. Food and Drug Administration (“FDA”) in third quarter 2025, and Tofidence® (tocilizumab-bavi), which the company acquired in the second quarter of 2025.

Established Brands revenue declined 2% as-reported and declined 5% ex-FX in the fourth quarter of 2025. Revenue contributions from Emgality®⁽¹⁾ (galcanezumab-gnlm), Vtama®⁽²⁾ (tapinarof) and Arcoxia^TM (etoricoxib) partially offset a decline in the respiratory portfolio which was driven by pricing pressure, particularly in the U.S. and China, as well as volume declines related to the adoption of revised medical guidelines that deprioritize the use of montelukast, including Singulair® (montelukast sodium), in various international markets.

^{(1) Organon acquired certain European licensing and distribution rights to Emgality and Rayvow from Eli Lilly and Company (“Eli Lilly”) beginning in early 2024. Emgality and Rayvow are registered trademarks of Eli Lilly in the European Union and other countries (used under license).}

^{(2) Vtama was acquired as part of Organon's acquisition of Dermavant Sciences Ltd. (“Dermavant”), which closed on October 28, 2024.}

Fourth Quarter 2025 Profitability

in $ millions, except per share amounts		Q4 2025				Q4 2024				VPY
Revenues		$	1,507			$	1,592			(5)%
Cost of sales			766				696			10%
Gross profit			741				896			(17)%
Non-GAAP Adjusted gross profit (1)			854				965			(12)%
Net (loss) income			(205	)			109			NM
Non-GAAP Adjusted net income (1)			165				235			(30)%
Diluted (Loss) Earnings per Share (EPS)			(0.79	)			0.42			NM
Non-GAAP Adjusted diluted EPS (1)			0.63				0.90			(30)%
Acquired in-process research & development (IPR&D) and milestones			—				—			—%
Adjusted EBITDA (Non-GAAP) (1)			383				448			(15)%
		Q4 2025				Q4 2024
Gross margin			49.2	%			56.3	%
Non-GAAP Adjusted gross margin (1)			56.7	%			60.6	%
Adjusted EBITDA margin (Non-GAAP) (1, 2)			25.4	%			28.1	%
(1) See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures.

Reported gross margin in the fourth quarter of 2025 was 49.2% compared with 56.3% in the prior year period. One-time costs associated with optimizing the company’s manufacturing and supply network were the most significant driver of the year-over-year decline in reported gross margin. Non-GAAP Adjusted gross margin was 56.7% in the fourth quarter of 2025, compared to 60.6% in the fourth quarter of 2024. Unfavorable pricing, foreign exchange rates and product mix were notable drivers in the decline of both reported gross margin and non-GAAP Adjusted gross margin.

Net loss for the fourth quarter of 2025 was $205 million, or $0.79 per diluted share, compared with net income of $109 million, or $0.42 per diluted share, in the fourth quarter of 2024. Net loss for the fourth quarter of 2025 includes a non-cash goodwill impairment of $301 million, or $1.16 per share, related to underperformance of several products in the U.S. For the fourth quarter of 2025, non-GAAP Adjusted net income was $165 million, or $0.63 per diluted share, compared with $235 million, or $0.90 per diluted share, in 2024.

Non-GAAP Adjusted EBITDA margin was 25.4% in the fourth quarter of 2025 compared with 28.1% in the fourth quarter of 2024. The year-over-year decline in the fourth quarter 2025 Adjusted EBITDA margin was primarily driven by the lower Adjusted Gross Margin, which was only partially offset by a 5% reduction in non-GAAP operating expenses.

Full Year 2025 Revenue

in $ millions		FY 2025			FY 2024			VPY		VPY ex-FX
Women’s Health		$	1,752		$	1,777		(1)%		(2)%
General Medicines
Biosimilars			691			662		4%		5%
Established Brands			3,691			3,849		(4)%		(5)%
Other (1)			82			115		(28)%		(28)%
Revenue		$	6,216		$	6,403		(3)%		(3)%
Totals may not foot due to rounding and percentages are computed using unrounded amounts.
(1) Other includes manufacturing sales to third parties.

Full year 2025 revenue was $6.2 billion, a decrease of 3% on both an as-reported basis and at constant currency as compared with full year 2024.

Women’s Health revenue declined 1% as-reported and 2% ex-FX for full year 2025, compared with 2024. Growth in the company’s fertility business and in the JADA® system substantially offset a 23% ex-FX decline in NuvaRing® (etonogestrel / ethinyl estradiol vaginal ring) and a 4% ex-FX decline in Nexplanon. Strong growth in Nexplanon outside the U.S. helped to offset a 9% decline in the U.S. where access has been restricted by U.S. policy since early 2025. The company’s fertility business grew 8% ex-FX for full year 2025 driven by performance in the U.S., particularly in the first half of 2025, as well as geographic footprint expansion, which together offset declines in China driven by socio-economic trends. For full year 2025, the JADA® system delivered $74 million of revenue. On January 28, 2026 the company completed the divestiture of the JADA® system.

Biosimilars revenue increased 4% on an as-reported basis and 5% on an ex-FX basis for full year 2025, compared with the prior year, primarily driven by continued growth in Hadlima. Renflexis and Ontruzant declined 8% ex-FX and 30% ex-FX, respectively, as both products are in the mature phase of their product life cycles and face significant competitive pricing pressure in the U.S. and Europe.

Revenue for Established Brands declined 4% on an as-reported basis and 5% ex-FX for full year 2025. Contributions from Emgality and Vtama partially offset the aforementioned declines in the respiratory portfolio and the impact from the loss of exclusivity of Atozet in Europe and Japan.

Full Year 2025 Profitability

in $ millions, except per share amounts		2025				2024				VPY
Revenues		$	6,216			$	6,403			(3)%
Cost of sales			2,903				2,688			8%
Gross profit			3,313				3,715			(11)%
Non-GAAP Adjusted gross profit (1)			3,737				3,944			(5)%
Net income			187				864			(78)%
Non-GAAP Adjusted net income (1)			954				1,065			(10)%
Diluted Earnings per Share (EPS)			0.72				3.33			(78)%
Non-GAAP Adjusted diluted EPS (1)			3.66				4.11			(11)%
Acquired in-process research & development (IPR&D) and milestones			6				81			(93)%
Adjusted EBITDA (1, 2)			1,907				1,958			(3)%
		2025				2024
Gross margin			53.3	%			58.0	%
Non-GAAP Adjusted gross margin (1)			60.1	%			61.6	%
Adjusted EBITDA margin (1, 2)			30.7	%			30.6	%
(1) See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures.
(2) Adjusted EBITDA and Adjusted EBITDA margin include $6 million in 2025 and $81 million in 2024 related to acquired IPR&D and milestones.

Reported gross margin was 53.3% for full year 2025 compared with 58.0% for full year 2024. One-time costs associated with optimizing the company’s manufacturing and supply network were the most significant driver in the year-over-year decline in reported gross margin, followed by amortization expense and acquisition-related costs associated with the company’s purchase of Dermavant in October 2024. Adjusted gross margin was 60.1% for full year 2025, compared with 61.6% for full year 2024. Pricing pressure adversely impacted both reported and Adjusted gross margin.

Adjusted EBITDA margin was 30.7% for full year 2025 consistent with full year 2024 as the decline in Adjusted gross margin was substantially offset by lower R&D expense.

Net income for full year 2025 was $187 million, or $0.72 per diluted share, compared with $864 million, or $3.33 per diluted share in 2024. Full year 2025 reported net-income includes the aforementioned fourth quarter goodwill impairment. Non-GAAP Adjusted net income was $954 million for full year 2025, or $3.66 per share, compared with $1,065 million, or $4.11 per share, in full year 2024.

Other Matters
On February 11, 2026, information was brought to the Audit Committee’s attention relating to the timing of the company’s purchases of biosimilars from a supplier in prior years. A review by the Audit Committee will ensue. At this time, the company has not determined that anything inappropriate occurred in connection with these purchases. The company is not aware of the need for any changes to prior financial statements, and currently anticipates that it will be able to timely file its Form 10-K for the year ended December 31, 2025 and update its disclosure in relation to this matter.

Capital Allocation
Today, Organon’s Board of Directors declared a quarterly dividend of $0.02 for each issued and outstanding share of the company's common stock. The dividend is payable on March 12, 2026, to stockholders of record at the close of business on February 23, 2026.

As of December 31, 2025, cash and cash equivalents were $574 million, and debt was $8.64 billion.

Full Year Guidance
Organon does not provide GAAP financial measures on a forward-looking basis because the company cannot predict with reasonable certainty and without unreasonable effort, the ultimate outcome of legal proceedings, unusual gains and losses, the occurrence of matters creating GAAP tax impacts, and acquisition-related expenses. These items are uncertain, depend on various factors, and could be material to Organon’s results computed in accordance with GAAP.

For full year 2026, the company expects to achieve revenue of approximately $6.2 billion and Adjusted EBITDA of approximately $1.9 billion; both measures in-line with 2025 performance. The company expects that the annual revenue foregone with the sale of the JADA® system will be approximately offset by favorable currency translation, resulting in constant currency revenue growth about flat with prior year, pro forma for the JADA® system divestiture.

Full year 2026 financial guidance is presented below on a non-GAAP basis, except revenue.

	Full Year 2025 Actuals	Full Year 2026 Guidance
Revenue	$6.216B	~$6.2B
Nominal revenue growth	(3)%	~flat
FX translation impact	~$35M	~75M
Ex-FX revenue growth	(3%)	~(1.5%)
Adjusted gross margin	60.1%	~75-100 bps lower than 2025
SG&A	26.1%	Mid 20% range
R&D	5.5%	Mid-single digit range
IPR&D*	$6M	N/A
Adjusted EBITDA (non-GAAP)	$1.91B	~$1.9B
Interest	$504M	~$500M
Depreciation	$141M	~$140M
Effective non-GAAP tax rate	24.4%	27.5%-29.5%
Fully diluted weighted average shares outstanding	261M	~265M
*The company does not provide guidance for forward-looking IPR&D and milestone expense.

Webcast Information
Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its fourth quarter and full year financial results. To listen to the event and view the presentation slides via webcast, join from the Organon Investor Relations website at https://www.organon.com/investor-relations/events-and-presentations/. A replay of the webcast will be available approximately two hours after the conclusion of the live event on the company’s website. Institutional investors and analysts interested in participating in the call may join by dialing (888) 596-4144 (U.S. and Canada Toll-Free) or (646) 968-2525 and using the access code Conference ID: 1036555#.

About Organon
Organon (NYSE: OGN) 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 markets.

Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at http://www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook.

Cautionary Note Regarding Non-GAAP Financial Measures
This press release contains “non-GAAP financial measures,” which are financial measures that either exclude or include amounts that are correspondingly not excluded or included in the most directly comparable measures calculated and presented in accordance with U.S. generally accepted accounting principles (“GAAP”). Specifically, the company makes use of the non-GAAP financial measures Adjusted EBITDA, Adjusted EBITDA margin, Adjusted gross margin, Adjusted gross profit, Adjusted net income, and Adjusted diluted EPS, which are not recognized terms under GAAP and are presented only as a supplement to the company’s GAAP financial statements. This press release also provides certain measures that exclude the impact of foreign exchange. We calculate foreign exchange by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. The company believes that these non-GAAP financial measures help to enhance an understanding of the company’s financial performance. However, the presentation of these measures has limitations as an analytical tool and should not be considered in isolation, or as a substitute for the company’s results as reported under GAAP. Because not all companies use identical calculations, the presentations of these non-GAAP measures may not be comparable to other similarly titled measures of other companies. Please refer to Table 4 and Table 5 of this press release for additional information, including relevant definitions and reconciliations of non-GAAP financial measures contained herein to the most directly comparable GAAP measures.

In addition, the company’s full-year 2026 guidance measures (other than revenue) are provided on a non-GAAP basis because the company is unable to reasonably predict certain items contained in the GAAP measures. Such items include, but are not limited to, acquisition-related expenses, restructuring and related expenses, stock-based compensation, the ultimate outcome of legal proceedings, unusual gains and losses, the occurrence of matters creating GAAP tax impacts and other items not reflective of the company's ongoing operations.

The company’s management uses the non-GAAP financial measures described above to evaluate the company’s performance and to guide operational and financial decision making. Further, the company’s management believes that these non-GAAP financial measures, which exclude certain items, help to enhance its ability to meaningfully communicate its underlying business performance, financial condition and results of operations.

Cautionary Note Regarding Forward-Looking Statements
Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about management’s expectations about the Audit Committee’s review described above, Organon’s full-year 2026 guidance estimates and predictions regarding other financial information and metrics, as well as expectations regarding Organon’s franchise and product performance and strategy expectations for future periods. Forward-looking statements may be identified by words such as “guidance,” “potential,” “should,” “will,” “continue,” “expects,” “believes,” “future,” “estimates,” “opportunity,” “likely,” “pursue,” “drive,” “intend,” “anticipate,” “be able to,” or words of similar meaning. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include, but are not limited to, the timing and completion of the Audit Committee’s review and result thereof; 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; changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, and/or marketing of our products and related intellectual property, environmental regulations, and the enforcement thereof affecting the company’s business; the impact of tariffs and other trade restrictions or domestic sourcing requirements; changes in tax laws including changes related to the taxation of foreign earnings; economic factors over which we have no control, including changes in inflation, interest rates, recessionary pressures, and foreign currency exchange rates; the company’s inability to remediate the material weaknesses in its internal control over financial reporting; the company’s use of artificial intelligence technologies; the company’s ability to execute on its capital allocation priorities and to deleverage its business; the impact of our substantial levels of indebtedness; expanded brand and class competition in the markets in which the company operates; difficulties with performance of third parties the company relies on for its business growth; the failure of any supplier to provide substances, materials, or services as agreed, or otherwise meet their obligations to the company; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as the company’s products lose patent protection; any failure by the company to retain market exclusivity for Nexplanon® (etonogestrel implant) 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 continued impact of the September 2024 loss of exclusivity for Atozet™ (ezetimibe and atorvastatin); the success of the company’s efforts to adopt its business and sales strategies to address the changing market and regulatory landscape in order to achieve its business objectives and remain competitive; restructuring or other disruptions at the FDA, the U.S. Securities and Exchange Commission (the “SEC”) and other U.S. and comparable foreign government agencies; cyberattacks on, or other failures, accidents, or security breaches of, the company’s or third-party providers’ information technology systems, which could disrupt the company’s operations and those of third parties upon which it relies; 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 the company’s business; difficulties and uncertainties inherent in the implementation of the company’s business development strategy or failure to recognize the benefits of strategic transactions; the impact of higher selling and promotional costs; efficacy, safety or other quality concerns with respect to the company’s 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 the company’s product candidates in pre-clinical and clinical trials, which may prevent or delay the development, approval, clearance, or commercialization of the company’s product candidates; 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, including product liability claims, antitrust litigation and governmental investigations, including tax disputes, environmental claims and patent disputes with branded and generic competitors, any of which could preclude commercialization of products or negatively affect the profitability of existing products; 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 the company or its third party collaborators and/or their suppliers to fulfill their or their regulatory or quality obligations, which could lead to a delay in regulatory approval or commercial marketing of the company’s products; the impact of any future pandemic, epidemic, or similar public health threat on the company’s business, operations and financial performance; the company’s ability to hire and retain a permanent CEO, other members of the company’s senior management, or other key employees; changes in accounting pronouncements promulgated by standard-setting or regulatory bodies, including the Financial Accounting Standards Board and the SEC, that are adverse to the company; volatility of commodity prices, fuel, and shipping rates that impact the costs and/or ability to supply the company’s products; and uncertainties surrounding matters relating to the Audit Committee investigation and any related investigations, inquiries, claims, proceedings or actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s filings with the SEC, including the company’s most recent Annual Report on Form 10-K (as amended), Quarterly Reports on Form 10-Q (as amended), Current Reports on Form 8-K, and other SEC filings, available at the SEC’s Internet site (www.sec.gov).

TABLE 1
Organon & Co.
Condensed Consolidated Statement of Income
(Unaudited, $ in millions except shares in thousands and per share amounts)
	Three Months Ended December 31,							Year Ended December 31,
	2025				2024			2025				2024
Revenues	$	1,507			$	1,592		$	6,216			$	6,403
Cost of sales		766				696			2,903				2,688
Gross Profit		741				896			3,313				3,715
Selling, general and administrative		433				470			1,721				1,760
Research and development		91				130			366				469
Acquired in-process research and development and milestones		—				—			6				81
Goodwill impairment		301				—			301				—
Restructuring costs		7				8			95				31
Interest expense		121				132			504				520
Exchange losses		2				15			14				26
Other (income) expense, net		(66	)			12			(119	)			21
(Loss) Income before income taxes		(148	)			129			425				807
Income tax expense (benefit)		57				20			238				(57	)
Net (loss) income	$	(205	)		$	109		$	187			$	864
(Loss) Earnings per share:
Basic	$	(0.79	)		$	0.42		$	0.72			$	3.36
Diluted	$	(0.79	)		$	0.42		$	0.72			$	3.33
Weighted average shares outstanding:
Basic		260,172				257,690			259,495				257,046
Diluted		260,172				259,878			260,764				259,152

TABLE 2
Organon & Co.
Sales by top products
(Unaudited, $ in millions)
	Three Months Ended December 31,																			Year Ended December 31,
	2025										2024									2025									2024
($ 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	$	125			$	86		$	211		$	175		$	83		$	258		$	610		$	311		$	921		$	672		$	291		$	963
Follistim AQ		23				35			58			26			39			65			112			152			264			84			152			237
NuvaRing		(2	)			18			15			6			18			24			19			72			91			39			75			115
Ganirelix Acetate Injection		2				22			24			4			24			28			12			89			101			20			89			109
Marvelon/Mercilon		—				24			24			—			31			31			—			127			127			—			134			134
Jada		20				—			20			18			—			18			73			1			74			60			1			61
Other Women’s Health (1)		17				29			46			15			27			42			65			109			174			56			104			158
General Medicines
Biosimilars
Renflexis		42				19			61			52			13			65			183			69			251			219			55			274
Hadlima		50				18			68			33			11			44			166			62			228			104			38			142
Ontruzant		3				15			19			6			28			34			15			84			99			29			112			141
Brenzys		—				21			21			—			15			15			—			80			80			—			77			77
Other Biosimilars (1)		8				3			12			—			6			6			17			16			33			—			28			28
Established Brands
Cardiovascular
Atozet		—				67			67			—			76			76			—			324			324			—			473			473
Zetia		1				89			91			2			75			77			5			337			342			7			310			317
Cozaar/Hyzaar		2				51			53			2			55			57			8			211			219			9			234			243
Vytorin		1				24			25			2			24			26			4			96			100			6			102			108
Rosuzet		—				7			7			—			13			13			—			24			24			—			49			49
Other Cardiovascular (1)		2				28			28			—			34			34			3			124			126			2			130			133
Respiratory
Singulair		2				57			59			2			82			84			8			244			252			9			350			359
Nasonex		—				64			64			—			76			76			—			261			262			—			276			276
Dulera		24				11			35			42			11			52			113			39			153			162			42			203
Clarinex		1				29			30			—			27			28			2			121			123			3			125			127
Other Respiratory (1)		11				3			13			13			4			17			42			12			52			38			13			53
Non-Opioid Pain, Bone and Dermatology
Arcoxia		—				70			70			—			58			58			—			265			265			—			270			270
Fosamax		—				35			36			—			38			38			2			141			143			3			147			151
Diprospan		—				38			38			—			36			36			—			150			150			—			139			139
Vtama		31				8			39			10			1			12			111			17			128			10			1			12
Other Non-Opioid Pain, Bone and Dermatology (1)		5				68			72			3			69			71			16			285			301			19			279			295
Other
Propecia		2				27			28			1			31			32			6			112			118			6			105			111
Emgality		—				50			50			—			38			38			—			174			174			—			107			107
Proscar		—				24			24			—			22			22			1			96			97			1			94			95
Other (1)		2				82			84			3			83			87			10			327			338			14			314			328
Other (2)		—				13			15			1			28			28			1			80			82			—			115			115
Revenues	$	372			$	1,135		$	1,507		$	416		$	1,176		$	1,592		$	1,604		$	4,612		$	6,216		$	1,572		$	4,831		$	6,403
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.
(1) Includes sales of products not listed separately.
(2) Other includes manufacturing sales to third parties.

TABLE 3
Organon & Co.
Sales by geographic area
(Unaudited, $ in millions)
	Three Months Ended December 31,						Year Ended December 31,
	2025			2024			2025			2024
Europe and Canada	$	405		$	420		$	1,618		$	1,763
United States		372			416			1,604			1,572
Asia Pacific and Japan		248			244			1,000			1,050
China		202			213			829			847
Latin America, Middle East, Russia, and Africa		262			266			1,072			1,034
Other (1)		18			33			93			137
Revenues	$	1,507		$	1,592		$	6,216		$	6,403
(1) Other includes manufacturing sales to third parties.

TABLE 4
Organon & Co.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics
(Unaudited, $ in millions)
	Three Months Ended December 31,								Year Ended December 31,
	2025				2024				2025				2024
GAAP Gross Profit	$	741			$	896			$	3,313			$	3,715
Adjusted for:
Spin-related costs (1)		—				—				—				6
Manufacturing network costs (2)		41				15				142				54
Stock-based compensation		2				4				14				17
Amortization		50				43				205				145
Acquisition-related costs (3)		18				7				49				7
Other		2				—				14				—
Adjusted Non-GAAP Gross Profit	$	854			$	965			$	3,737			$	3,944
(1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5.
(2) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. For additional details refer to Table 5.
(3) Acquisition-related costs relate to costs from the acquisition of Dermavant. For additional details refer to Table 5.
	Three Months Ended December 31,								Year Ended December 31,
	2025				2024				2025				2024
GAAP Gross Margin		49.2	%			56.3	%			53.3	%			58.0	%
Total impact of Non-GAAP adjustments		7.5	%			4.3	%			6.8	%			3.6	%
Adjusted Non-GAAP Gross Margin		56.7	%			60.6	%			60.1	%			61.6	%
	Three Months Ended December 31,								Year Ended December 31,
	2025				2024				2025				2024
GAAP Selling, general and administrative expenses	$	433			$	470			$	1,721			$	1,760
Adjusted for:
Spin-related costs (1)		—				(9	)			—				(88	)
Stock-based compensation		(3	)			(17	)			(49	)			(70	)
Acquisition-related costs (2)		—				(24	)			—				(28	)
Restructuring related charges		—				—				(10	)			—
Other		(5	)			(3	)			(39	)			(3	)
Adjusted Non-GAAP Selling, general and administrative expenses	$	425			$	417			$	1,623			$	1,571
(1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5.
(2) Acquisition-related costs relate to costs from the acquisition of Dermavant. For additional details refer to Table 5.

TABLE 4
Organon & Co.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Continued)
(Unaudited, $ in millions except per share amounts)
	Three Months Ended December 31,								Year Ended December 31,
	2025				2024				2025				2024
GAAP Research and development expenses	$	91			$	130			$	366			$	469
Adjusted for:
Spin-related costs (1)		—				(6	)			—				(11	)
Manufacturing network costs (2)		(3	)			—				(11	)			—
Stock-based compensation		(2	)			(5	)			(14	)			(18	)
Other		(2	)			—				(5	)			—
Adjusted Non-GAAP Research and development expenses	$	84			$	119			$	336			$	440
(1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5.
(2) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. For additional details refer to Table 5.
	Three Months Ended December 31,								Year Ended December 31,
	2025				2024				2025				2024
GAAP Reported Net (Loss) Income	$	(205	)		$	109			$	187			$	864
Adjusted for:
Cost of sales adjustments		113				69				424				229
Selling, general and administrative adjustments		8				53				98				189
Research and development adjustments		7				11				30				29
Goodwill impairment		301				—				301				—
Restructuring		7				8				95				31
Change in fair value of contingent consideration		(41	)			11				(50	)			11
Other (gain) expense, net		(24	)			2				(61	)			16
Tax impact on adjustments above(1)		(1	)			(28	)			(70	)			(304	)
Non-GAAP Adjusted Net Income	$	165			$	235			$	954			$	1,065
(1) For the three months ended December 31, 2025 and 2024, the GAAP income tax rates were (38.9)% and 15.3%, respectively, and the non-GAAP income tax rates were 26.3% and 17.1%, respectively. For the year ended December 31, 2025 and 2024, the GAAP income tax rates were 56.0% and (7.1)%, respectively, and the non-GAAP income tax rates were 24.4% and 18.8%, respectively. These adjustments represent the estimated tax impacts on the reconciling items by applying the statutory rate and applicable law of the originating territory of the non-GAAP adjustments.
	Three Months Ended December 31,								Year Ended December 31,
	2025				2024				2025				2024
GAAP Diluted (Loss) Earnings per Share	$	(0.79	)		$	0.42			$	0.72			$	3.33
Total impact of Non-GAAP adjustments		1.42				0.48				2.94				0.78
Non-GAAP Adjusted Diluted Earnings per Share	$	0.63			$	0.90			$	3.66			$	4.11

TABLE 5
Organon & Co.
Reconciliation of GAAP Net (Loss) Income to Non-GAAP Adjusted EBITDA
(Unaudited, $ in millions)
	Three Months Ended December 31,								Year Ended December 31,
	2025				2024				2025				2024
GAAP Reported Net (Loss) Income	$	(205	)		$	109			$	187			$	864
Depreciation (1)		39				33				141				126
Amortization		50				43				205				145
Interest expense		121				132				504				520
Income tax expense (benefit)		57				20				238				(57	)
EBITDA (Non-GAAP)	$	62			$	337			$	1,275			$	1,598
Restructuring and related charges		7				8				105				31
Spin-related costs (2)		—				17				—				121
Manufacturing network related (3)		45				15				163				54
Acquisition-related costs (4)		18				31				49				35
Change in contingent consideration		(41	)			11				(50	)			11
Goodwill impairment		301				—				301				—
Other costs (5)		(16	)			3				(13	)			3
Stock-based compensation		7				26				77				105
Adjusted EBITDA (Non-GAAP)	$	383			$	448			$	1,907			$	1,958
Adjusted EBITDA margin (Non-GAAP)		25.4	%			28.1	%			30.7	%			30.6	%
(1) Excludes accelerated depreciation included in one-time costs.
(2) Spin-related costs reflect certain costs incurred in connection with activities taken to separate Organon from Merck & Co., Inc., Rahway, NJ, US. These costs include, but are not limited to, $6 million and $53 million for the three months and year ended December 31, 2024, respectively, for information technology infrastructure, primarily related to the implementation of a stand-alone enterprise resource planning system and redundant software licensing costs, as well as $20 million for the year ended December 31, 2024, associated with temporary transition service agreements with Merck & Co., Inc., Rahway, NJ, US.
(3) Manufacturing network related costs, including exiting of temporary manufacturing and supply agreements with Merck & Co., Inc., Rahway, NJ, US, reflect accelerated depreciation, exit premiums, technology transfer costs, stability and qualification batch costs, and third-party contractor costs.
(4) Acquisition related costs for the three months and year ended December 31, 2025, reflect the amortization pertaining to the fair value inventory purchase accounting adjustment for the Dermavant transaction. Acquisition-related costs for the three months and year ended December 31, 2024 reflect $8 million and $12 million, respectively, of transaction related costs, $10 million of Dermavant transaction bonuses and separation charges and $7 million and $12 million, respectively, of amortization pertaining to the fair value inventory purchase accounting adjustment.
(5) Other costs for the three months and year ended December 31, 2025 include $27 million and $69 million, respectively, pre-tax gain related to the repurchase and cancellation of approximately $177 million and $419 million, respectively, of the company’s 5.125% notes due in 2031 and the repayment and termination of the funding agreement with NovaQuest Co-Investment Fund VIII, L.P. and legal settlement reserves.
As the costs described in (1) through (5) above are directly related to the separation of Organon and acquisition related activities and therefore arise from a one-time event outside of the ordinary course of the company’s operations, the adjustment of these items provides meaningful, supplemental, information that the company believes will enhance an investor's understanding of the company's ongoing operating performance.

 

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Source: Organon & Co.