Montelukast sodium

First quarter 2026 revenue of $1.460 billion, down 4% as-reported and down 9% excluding the impact of foreign currency. First quarter 2026 diluted earnings per share of $0.55 and non-GAAP Adjusted diluted earnings per share of $0.71. First quarter 2026 net income of $146 million and Adjusted EBITDA (non-GAAP) of $415 million, representing an Adjusted EBITDA margin of 28.4%. On April 26, 2026, the company announced its pending merger into Sun Pharmaceutical Industries Limited (together with its subsidiaries and/or associated companies, “Sun Pharma”) in an all-cash transaction (the “merger”). The merger is expected to close in early 2027, subject to customary closing conditions, including receipt of required regulatory approvals and approval by Organon stockholders. In light of the pending merger, Organon will not be providing financial guidance or hosting quarterly earnings calls. JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon (NYSE: OGN) today announced its results for the first quarter ended March 31, 2026. First Quarter 2026 Revenue in $ millions Q1 2026 Q1 2025 VPY VPY ex-FX Women’s Health $ 389 $ 463 (16)% (19)% General Medicines Biosimilars 173 141 23% 21% Established Brands 880 887 (1)% (7)% Other (1) 18 22 (15)% (21)% Revenue $ 1,460 $ 1,513 (4)% (9)% Totals may not foot due to rounding and percentages are computed using unrounded amounts. (1) Other includes manufacturing sales to third parties. For the first quarter of 2026, total revenue was $1.460 billion, down 4% on an as-reported basis and down 9% excluding the impact of foreign currency (ex-FX), compared with the first quarter of 2025. Women’s Health revenue declined 16% as-reported and declined 19% ex-FX in the first quarter of 2026, compared with the first quarter of 2025. Sales of Nexplanon® (etonogestrel implant) decreased 21% ex-FX in the first quarter compared with the first quarter of 2025. In the U.S., sales of Nexplanon declined 28% primarily due to both decreased physician demand following the five-year label approval which as expected, has delayed reinsertions; and continued uncertainty around federal funding. Outside of the U.S., Nexplanon sales declined 4% ex-FX, due to the timing of shipments in selective emerging markets, partially offset by increased demand and access in Brazil. Sales of oral contraceptives Marvelon TM (desogestrel and ethinyl estradiol pill) and Mercilon TM (desogestrel and ethinyl estradiol pill) declined 36% ex-FX in the first quarter of 2026 primarily due to decreased demand and market contraction in China and the timing of shipments in Asia Pacific. Global Fertility revenue was down 9% ex-FX as a result of competition-driven price reductions in the U.S. partially offset by modest market growth in China. In January of 2026 the company completed the sale of the Jada® system to Laborie. Biosimilars revenue increased 23% as-reported and 21% ex-FX in the first quarter of 2026, compared with the first quarter of 2025, primarily due to the strong performance of Hadlima® (adalimumab-bwwd) associated with stronger demand in the U.S., and increased demand in Puerto Rico. Biosimilars 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 the third quarter of 2025, and Tofidence® (tocilizumab-bavi), which the company acquired in the second quarter of 2025. Established Brands revenue declined 1% as-reported and declined 7% ex-FX in the first quarter of 2026. Revenue contribution from Emgality® (1) (galcanezumab-gnlm) partially offset a decline in the respiratory portfolio, which was driven by pricing pressure, 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, most recently, in China. Global sales of Dulera® (mometasone furoate and formoterol fumarate dihydrate) also declined in the first quarter of 2026 primarily due to pricing pressure and decreased demand in the U.S. VTAMA ® (tapinarof) grew modestly in the first quarter of 2026 compared with the first quarter of 2025. (1) Organon acquired certain European licensing and distribution rights to Emgality from Eli Lilly and Company (“Eli Lilly”) beginning in early 2024. Emgality is a registered trademark of Eli Lilly in the European Union and other countries (used under license). First Quarter 2026 Profitability in $ millions, except per share amounts Q1 2026 Q1 2025 VPY Revenues $ 1,460 $ 1,513 (4)% Cost of sales 677 672 1% Gross profit 783 841 (7)% Non-GAAP Adjusted gross profit (1) 861 934 (8)% Net income 146 87 68% Non-GAAP Adjusted net income (1) 188 265 (29)% Diluted Earnings per Share (EPS) 0.55 0.33 67% Non-GAAP Adjusted diluted EPS (1) 0.71 1.02 (30)% Acquired in-process research & development (IPR&D) and milestones — 6 NM Adjusted EBITDA (Non-GAAP) (1) 415 484 (14)% Q1 2026 Q1 2025 Gross margin 53.6 % 55.6 % Non-GAAP Adjusted gross margin (1) 59.0 % 61.7 % Adjusted EBITDA margin (Non-GAAP) (1, 2) 28.4 % 32.0 % (1) See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures. Reported gross margin in the first quarter of 2026 was 53.6% compared with 55.6% in the prior year period. Non-GAAP Adjusted gross margin was 59.0% in the first quarter of 2026, compared to 61.7% in the first quarter of 2025. Unfavorable pricing and product mix as well as foreign exchange rates were notable drivers in the decline of both reported gross margin and non-GAAP Adjusted gross margin. Net income for the first quarter of 2026 was $146 million, or $0.55 per diluted share, compared with net income of $87 million, or $0.33 per diluted share, in the first quarter of 2025. For the first quarter of 2026, non-GAAP Adjusted net income was $188 million, or $0.71 per diluted share, compared with $265 million, or $1.02 per diluted share, for the first quarter of 2025. Non-GAAP Adjusted EBITDA margin was 28.4% in the first quarter of 2026 compared with 32.0% in the first quarter of 2025. The year-over-year decline was primarily driven by a decrease in Adjusted Gross Margin. 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 June 11, 2026, to stockholders of record at the close of business on May 11, 2026. As of March 31, 2026, cash and cash equivalents were $1.12 billion, and debt was $8.57 billion. Webcast Information As is customary during the pendency of an acquisition, Organon has suspended its quarterly earnings calls and will not host a conference call in conjunction with today’s first quarter earnings release. 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 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, Adjusted EPS, 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. 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 relating to the merger, including the anticipated timing of completion thereof. Forward-looking statements may be identified by words such as “proposed,” “will,” “continue,” “expects,” “believes,” “estimates,” “opportunity,” “pursue,” “anticipate,” “be able to,” “intend,” 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 uncertainties as to the timing of the merger; the risk that the merger may not be completed on the anticipated terms in a timely manner or at all; the failure to satisfy any of the conditions to the consummation of the merger, including receiving, on a timely basis or otherwise, the minimum vote required by Organon’s stockholders to approve the merger; the possibility that competing offers or acquisition proposals for Organon will be made; the possibility that any or all of the various conditions to the consummation of the merger may not be satisfied or waived, including the failure to receive any required regulatory approvals from any applicable governmental entities (or any conditions, limitations or restrictions placed on such approvals); the occurrence of any event, change or other circumstance that could give rise to the termination of the definitive agreement, including in circumstances which would require Organon to pay a termination fee; the effect of the announcement or pendency of the merger on Organon’s ability to retain and hire key personnel, its ability to maintain relationships with its customers, suppliers and others with whom it does business, or its operating results and business generally; risks related to diverting management’s attention from Organon’s ongoing business operations; the risk that stockholder litigation in connection with the merger may result in significant costs of defense, indemnification and liability; certain restrictions during the pendency of the merger that may impact Organon’s ability to pursue certain business opportunities or strategic transactions; the risk that any announcements relating to the merger could have adverse effects on the market price of Organon’s common stock, including if the merger is not consummated; risks that the benefits of the merger are not realized when and as expected; and legislative, regulatory and economic developments. 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, Current Report on Form 8-K, filed by the company on April 27, 2026, and other SEC filings, available at the SEC’s Internet site ( ). Additional Information and Where to Find It This press release may be deemed to be solicitation material in respect of the proposed merger. In connection with the merger, Organon intends to materials with the SEC, including Organon’s proxy statement in preliminary and definitive form on Schedule 14A (the “Merger Proxy Statement”). Organon will mail the Merger Proxy Statement and a proxy card to its stockholders in connection with the merger. INVESTORS AND STOCKHOLDERS OF ORGANON ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING THE MERGER PROXY STATEMENT (WHEN THEY ARE AVAILABLE), BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT ORGANON, SUN PHARMA AND THE MERGER AND RELATED MATTERS. Investors and stockholders of Organon are or will be able to obtain these documents (when they are available) free of charge from the SEC’s website at , or through the investor relations section of Organon’s website, . Participants in the Solicitation Organon and its directors, executive officers and other members of management and employees, under SEC rules, may be deemed to be “participants” in the solicitation of proxies from stockholders of Organon in favor of the proposed acquisition. Information about Organon’s directors and executive officers is set forth in the 2026 Annual Meeting Proxy Statement, filed with the SEC on April 24, 2026, and which is available at . To the extent holdings of Organon’s securities by its directors or executive officers have changed since the amounts set forth in the 2026 Annual Meeting Proxy Statement, such changes have been or will be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Change in Ownership on Form 4 filed with the SEC, which are available at . Additional information concerning the interests of Organon’s participants in the solicitation, which may, in some cases, be different than those of Organon’s stockholders generally, will be set forth in the Merger Proxy Statement when it becomes available. TABLE 1 Organon & Co. Condensed Consolidated Statement of Income (Unaudited, $ in millions except shares in thousands and per share amounts) Three Months Ended March 31, 2026 2025 Revenues $ 1,460 $ 1,513 Cost of sales 677 672 Gross Profit 783 841 Selling, general and administrative 424 420 Research and development 93 96 Acquired in-process research and development and milestones — 6 Restructuring costs 31 86 Interest expense 111 124 Exchange losses (gains) 7 (4 ) Other (income) expense, net (96 ) 12 Income before income taxes 213 101 Income tax expense 67 14 Net income $ 146 $ 87 Earnings per share: Basic $ 0.56 $ 0.34 Diluted $ 0.55 $ 0.33 Weighted average shares outstanding: Basic 260,370 257,862 Diluted 262,896 261,001 TABLE 2 Organon & Co. Sales by top products (Unaudited, $ in millions) Three Months Ended March 31, 2026 2025 ($ in millions) U.S. Int’l Total U.S. Int’l Total Women’s Health Nexplanon/Implanon NXT $ 127 $ 74 $ 201 $ 176 $ 72 $ 248 Follistim AQ 21 39 61 35 34 69 NuvaRing 6 18 24 6 16 22 Ganirelix Acetate Injection 2 24 26 5 23 27 Marvelon/Mercilon — 26 26 — 39 39 Jada 5 — 5 15 — 15 Other Women’s Health ( 1) 17 30 46 15 27 43 General Medicines Biosimilars Renflexis 42 15 57 44 12 57 Hadlima 51 16 67 33 14 47 Ontruzant 4 1 5 4 14 18 Brenzys — 20 20 — 14 14 Other Biosimilars (1) 11 13 24 — 5 5 Established Brands Cardiovascular Atozet — 85 85 — 77 77 Zetia 1 86 87 1 84 85 Cozaar/Hyzaar 2 55 57 2 53 55 Vytorin 1 20 21 1 22 23 Rosuzet — 6 6 — 4 4 Other Cardiovascular (1) 1 27 28 — 30 30 Respiratory Singulair 2 38 40 2 72 74 Nasonex — 65 65 — 71 72 Dulera 23 12 35 34 10 43 Clarinex 1 30 31 — 34 34 Other Respiratory (1) 11 1 12 10 3 13 Non-Opioid Pain, Bone and Dermatology Arcoxia — 59 59 — 62 62 Fosamax — 29 29 1 32 33 Diprospan — 35 35 — 30 30 Vtama 23 2 25 20 4 24 Other Non-Opioid Pain, Bone and Dermatology (1) 3 65 68 4 65 68 Other Propecia 1 28 30 1 24 26 Emgality — 54 54 — 32 32 Proscar — 26 26 — 24 24 Other (1) 3 85 87 3 76 78 Other (2) — 18 18 — 22 22 Revenues $ 358 $ 1,102 $ 1,460 $ 412 $ 1,101 $ 1,513 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 March 31, 2026 2025 Europe and Canada $ 412 $ 376 United States 358 412 Asia Pacific and Japan 226 251 China 194 204 Latin America, Middle East, Russia, and Africa 247 240 Other (1) 23 30 Revenues $ 1,460 $ 1,513 (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 March 31, 2026 2025 GAAP Gross Profit $ 783 $ 841 Adjusted for: Manufacturing network costs (1) 21 29 Stock-based compensation 3 4 Amortization 47 50 Acquisition-related costs (2) 7 9 Other — 1 Adjusted Non-GAAP Gross Profit $ 861 $ 934 (1) 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. (2) Acquisition-related costs relate to costs from the acquisition of Dermavant. For additional details refer to Table 5. Three Months Ended March 31, 2026 2025 GAAP Gross Margin 53.6 % 55.6 % Total impact of Non-GAAP adjustments 5.4 % 6.1 % Adjusted Non-GAAP Gross Margin 59.0 % 61.7 % Three Months Ended March 31, 2026 2025 GAAP Selling, general and administrative expenses $ 424 $ 420 Adjusted for: Stock-based compensation (13 ) (16 ) Restructuring related charges — (6 ) Other (13 ) (3 ) Adjusted Non-GAAP Selling, general and administrative expenses $ 398 $ 395 TABLE 4 Organon & Co. Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Continued) (Unaudited, $ in millions except per share amounts) Three Months Ended March 31, 2026 2025 GAAP Research and development expenses $ 93 $ 96 Adjusted for: Manufacturing network costs (1) (3 ) (3 ) Stock-based compensation (3 ) (4 ) Other (1 ) (1 ) Adjusted Non-GAAP Research and development expenses $ 86 $ 88 (1) 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 March 31, 2026 2025 GAAP Reported Net Income $ 146 $ 87 Adjusted for: Cost of sales adjustments 78 93 Selling, general and administrative adjustments 26 25 Research and development adjustments 7 8 Jada divestiture (81 ) — Restructuring 31 86 Change in fair value of contingent consideration (5 ) 11 Other (gain) expense, net (3 ) 4 Tax impact on adjustments above (1) (11 ) (49 ) Non-GAAP Adjusted Net Income $ 188 $ 265 (1) For the three months ended March 31, 2026 and 2025, the GAAP income tax rates were 31.4% and 13.4%, respectively, and the non-GAAP income tax rates were 29.3% and 19.2%, 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 March 31, 2026 2025 GAAP Diluted Earnings per Share $ 0.55 $ 0.33 Total impact of Non-GAAP adjustments 0.16 0.69 Non-GAAP Adjusted Diluted Earnings per Share $ 0.71 $ 1.02 TABLE 5 Organon & Co. Reconciliation of GAAP Net (Loss) Income to Non-GAAP Adjusted EBITDA (Unaudited, $ in millions) Three Months Ended March 31, 2026 2025 GAAP Reported Net Income $ 146 $ 87 Depreciation (1) 38 32 Amortization 47 50 Interest expense 111 124 Income tax expense (benefit) 67 14 EBITDA (Non-GAAP) $ 409 $ 307 Restructuring and related charges 31 92 Manufacturing network related (2) 27 36 Acquisition-related costs (3) 7 9 Change in contingent consideration (5 ) 11 Jada divestiture (81 ) — Other costs 8 5 Stock-based compensation 19 24 Adjusted EBITDA (Non-GAAP) $ 415 $ 484 Adjusted EBITDA margin (Non-GAAP) 28.4 % 32.0 % (1) Excludes accelerated depreciation included in one-time costs. (2) 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. (3) Acquisition related costs for the three months ended March 31, 2026 and 2025, reflect the amortization pertaining to the fair value inventory purchase accounting adjustment for the Dermavant transaction. As the costs described in (1) through (3) 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. 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

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 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 . 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 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