Galcanezumab-gnlm

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

Teva wins appeal in migraine patent fight with LillyICER suggests reworks to accelerated approvalBiovac brings in more than $100M to expand vaccine production facility Teva wins appeal in migraine patent fight with LillyA US appeals court has revived a patent lawsuit filed by Teva against Eli Lilly over their rival migraine drugs, reversing a prior ruling in the case. The US Court of Appeals for the Federal Circuit found that Teva's Ajovy (fremanezumab) patents were valid.The dispute dates back to 2018, when Teva alleged that Lilly's rival CGRP inhibitor Emgality (galcanezumab) infringed patents related to Ajovy. A jury agreed in 2022, awarding Teva $176.5 million in damages.But the victory proved short-lived. In 2023, a US district judge in Massachusetts threw out the verdict, ruling instead that Teva's patents — concerning the use of humanised anti-CGRP antagonist antibodies to treat headache — were invalid for lack of written description and enablement. Now that Teva has won its appeal, the case now heads back to Massachusetts federal court. Lilly disagrees with the decision and is "evaluating all ⁠available options," a company spokesman told Reuters, adding that the ruling doesn't affect its ability to provide Emgality to patients.-Anna BratulicICER suggests reworks to accelerated approvalThe Institute for Clinical and Economic Review (ICER) released a white paper on Thursday that offered ways the FDA can improve its accelerated approval pathway, including improving transparency so patients and their physicians understand the risks and benefits of taking a drug cleared via the speedy programme. "We can point to several successes where patients have benefited from expedited access to transformative medications," said ICER president and CEO Sarah K. Emond. "However, there are also many instances of regulatory inconsistency, lagged development of confirmatory trial data, and access restrictions that have limited patient use." ICER recommended that trials designed to support accelerated approval use endpoints that "matter most to patients," while encouraging the FDA to begin differentiating between surrogate endpoints that are most likely to predict a drug's success in a confirmatory trial. For those post-marketing studies, the organisation advised that drugmakers adopt an informed consent requirement for patient recruitment. The group also suggested that the US regulator implement procedures to re-review or rescind accelerated approvals if a confirmatory trial fails. -Elizabeth EatonBiovac brings in more than $100M to expand vaccine production facilityThe European Investment Bank and the International Finance Corp chipped in a €75 million ($88 million) "quasi-equity" investment and a $20-million loan, respectively, for the Biovac Institute to build out its vaccine facility in Cape Town, South Africa, according to a report from Bloomberg.Construction on the site is expected to finish by 2028. Once complete, the facility will be able to produce more than 400 million doses of multiple vaccines, from start to finish, without needing active pharmaceutical ingredients (APIs) from overseas. It will initially be focused on oral cholera vaccine production, followed by vaccines for polio, meningitis and pneumonia.The site expansion is projected to create more than 340 direct positions and 7000 indirect jobs.-Elizabeth Eaton