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

• 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

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

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

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

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.

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.

Contacts

Media Contacts:

Felicia Bisaro

(646) 703-1807

Kate Vossen

(732) 675-8448

Investor Contacts:

Jennifer Halchak

(201) 275-2711

Renee McKnight

(551) 204-6129

Read full story here