Galcanezumab-gnlm

Third quarter 2025 revenue of $1.602 billion, up 1% as-reported and down 1% excluding the impact of foreign currency Third quarter 2025 diluted earnings per share of $0.61 and non-GAAP Adjusted diluted earnings per share of $1.01 Third quarter 2025 net income of $160 million and Adjusted EBITDA (non-GAAP) of $518 million, representing an Adjusted EBITDA margin of 32.3% Revenue guidance range for full year 2025 lowered to $6.200 billion to $6.250 billion; Adjusted EBITDA margin guidance lowered to ~31.0% JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon (NYSE: OGN) today announced its results for the third quarter ended September 30, 2025. “I am humbled to be working alongside our talented team during this pivotal time for Organon,” said Joe Morrissey, Organon’s Interim Chief Executive Officer. “We are harnessing the company's many strengths, including a diverse portfolio that we expect will generate more than $900 million in free cash flow before one-time costs this year. We also remain committed to exercising cost discipline and reducing our debt burden proactively, where possible. These actions will create additional balance sheet capacity, positioning us to pursue future growth opportunities in women’s health and further our mission to deliver impactful medicines and solutions for a healthier every day.” Third Quarter 2025 Revenue in $ millions Q3 2025 Q3 2024 VPY VPY ex-FX Women’s Health $ 429 $ 440 (3)% (4)% General Medicines Biosimilars 196 165 19% 19% Established Brands 956 951 1% (3)% Other (1) 21 26 (15)% (18)% Revenue $ 1,602 $ 1,582 1% (1)% Totals may not foot due to rounding and percentages are computed using unrounded amounts. (1) Other includes manufacturing sales to third parties. For the third quarter of 2025, total revenue was $1.602 billion, up 1% on an as-reported basis and down 1% excluding the impact of foreign currency (ex-FX), compared with the third quarter of 2024. Women’s Health revenue declined 3% as-reported and declined 4% ex-FX in the third quarter of 2025, compared with the third quarter of 2024. Sales of Nexplanon® (etonogestrel implant) decreased 9% ex-FX in the quarter compared with the prior year period primarily due to lower demand in the United States primarily driven by decreased funding of government programs, partially offset by increased demand in Brazil and the timing of tenders, primarily in Mexico. Third quarter Nexplanon performance was partially offset with 5% ex-FX growth in NuvaRing® (etonogestrel / ethinyl estradiol vaginal ring), 4% ex-FX growth in MarvelonTM (desogestrel and ethinyl estradiol pill) and MercilonTM (desogestrel and ethinyl estradiol pill), as well as a 29% ex-FX increase in Jada® system. *Estimated net impact from pull-forward Nexplanon revenue associated with the company's sales practices for wholesalers in the U.S. as referenced in the company’s Current Report on Form 8-K, filed with the SEC on October 27, 2025, was approximately $2 million during the third quarter ended September 30, 2025. The company has ceased these sales practices for wholesalers. Biosimilars revenue increased 19% on both an as-reported basis and ex-FX in the third quarter of 2025, compared with the third quarter of 2024, primarily due to strong performance of Hadlima® (adalimumab-bwwd) and the favorable timing of an international tender for Ontruzant® (trastuzumab-dttb). To a lesser extent, during the third quarter the Biosimilars portfolio also benefitted from contribution from new assets; Bildyos® (denosumab-nxxp) and Bilprevda® (denosumab-nxxp), which was approved by the FDA in September 2025, and Tofidence® (tocilizumab-bavi), which the company acquired in the second quarter of 2025. Established Brands revenue increased 1% as-reported and declined 3% ex-FX in the third quarter of 2025. Revenue contribution of Emgality®(1) (galcanezumab-gnlm) and Vtama®(2) (tapinarof) partially offset the impact of the loss of exclusivity (“LOE”) of Atozet™ (ezetimibe and atorvastatin) in key markets in Europe as well as declines in the respiratory portfolio. Performance in the respiratory portfolio was primarily driven by an approximate 40% ex-FX decline in Singulair® (montelukast sodium), due to lower demand outside of the United States and the negative impact from price reductions in Japan and China as well as performance of Dulera® (formoterol and fumarate dihydrate), which declined 30% ex-FX primarily due to the loss of a customer contract in the first part of the year, combined with increased discount rate pressure in the United States, as well as supply constraints. (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. Third Quarter 2025 Profitability in $ millions, except per share amounts Q3 2025 Q3 2024 VPY Revenues $ 1,602 $ 1,582 1% Cost of sales 745 659 13% Gross profit 857 923 (7)% Non-GAAP Adjusted gross profit (1) 966 976 (1)% Net income 160 359 (55)% Non-GAAP Adjusted net income (1) 263 226 16% Diluted Earnings per Share (EPS) 0.61 1.38 (56)% Non-GAAP Adjusted diluted EPS (1) 1.01 0.87 16% Acquired in-process research & development (IPR&D) and milestones — 51 —% Adjusted EBITDA (Non-GAAP) (1, 2) 518 459 13% Q3 2025 Q3 2024 Gross margin 53.5 % 58.3 % Non-GAAP Adjusted gross margin (1) 60.3 % 61.7 % Adjusted EBITDA margin (Non-GAAP) (1, 2) 32.3 % 29.0 % (1) See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures. (2) Adjusted EBITDA and Adjusted EBITDA margin for Q3 2024 includes $51 million, related to acquired IPR&D and milestones. Reported gross margin in the third quarter of 2025 was 53.5% compared with 58.3% in the prior year period. One-time costs associated with optimizing the company’s manufacturing and supply network was the most significant driver in the year-over-year decline in reported gross margin. Non-GAAP Adjusted gross margin was 60.3% in the third quarter of 2025, compared to 61.7% in the third quarter of 2024. Unfavorable foreign exchange in inventory turns, pricing pressure and product mix were drivers in the decline of both reported gross margin and non-GAAP Adjusted gross margin. Net income for the third quarter of 2025 was $160 million, or $0.61 per diluted share, compared with $359 million, or $1.38 per diluted share, in the third quarter of 2024. For the third quarter of 2025, non-GAAP Adjusted net income was $263 million, or $1.01 per diluted share, compared with $226 million, or $0.87 per diluted share, in 2024. Non-GAAP Adjusted EBITDA margin was 32.3% in the third quarter of 2025 compared with 29.0% in the third quarter of 2024. The year-over-year improvement in Adjusted EBITDA margin was primarily driven by a 14% reduction in non-GAAP operating expenses. 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 December 11, 2025, to stockholders of record at the close of business on November 20, 2025. As of September 30, 2025, cash and cash equivalents were $672 million, and debt was $8.83 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. Full year 2025 financial guidance is presented below on a non-GAAP basis, except revenue. Previous Guidance as of August 5, 2025 Current Guidance Revenue $6.275B - $6.375B $6.200B - $6.250B Nominal revenue growth (2.0%) - (0.4%) (3.2%) - (2.4%) FX translation impact ~$50M headwind ~ $35M - $45M tailwind Ex-FX revenue growth (1.2%) - 0.3% (3.7%) - (3.1%) Adjusted gross margin 60.0%-61.0% Unchanged SG&A Mid 20% range Unchanged R&D Upper single-digit Unchanged IPR&D* $6 million Unchanged Adjusted EBITDA margin (Non-GAAP) 31.0%-32.0% ~31.0% Interest ~$510M Unchanged Depreciation ~$135M Unchanged Effective non-GAAP tax rate 22.5%-24.5% Unchanged Fully diluted weighted average shares outstanding ~263M Unchanged *The company does not provide guidance for forward-looking IPR&D and milestone expense. The $6 million of forecasted IPR&D expense reflects IPR&D expense recorded through September 30, 2025. Webcast Information Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its third quarter 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 2025 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 Organon’s full-year 2025 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,” 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, expanded brand and class competition in the markets in which Organon operates; trade protection measures and import or export licensing requirements, including the direct and indirect impacts of tariffs (including any potential pharmaceutical sector tariffs), trade sanctions or similar restrictions by the United States or other governments; changes in U.S. and foreign federal, state and local governmental funding allocations including the timing and amounts allocated to Organon’s customers and business partners; economic factors over which Organon has no control, including changes in inflation, interest rates, recessionary pressures, and foreign currency exchange rates; uncertainties surrounding the Audit Committee investigation described in Organon’s Current Report on Form 8-K, filed with the U.S. Securities and Exchange Commission (the “SEC”) on October 27, 2025 (the “Form 8-K”); the impact of litigation, regulatory investigations and inquiries, and other legal matters, including risks to Organon’s reputation and relationships with customers, wholesalers, suppliers, and other business partners; risks related to potential disruptions to Organon’s business as a result of the leadership changes announced in the Form 8-K, including the risk that appointing a new Chief Executive Officer may take longer than anticipated; Organon’s ability to remediate the material weaknesses in internal control over financial reporting and the related costs and management resources in connection therewith, as well as its ability to maintain effective controls over financial reporting and disclosure controls and procedures in the future; Organon’s ability to access the public securities and other capital and credit markets in accordance with its financial plans, the cost of such capital and overall condition of the capital and credit markets; actions that may be taken by credit rating agencies that could negatively affect either Organon’s access to or terms of financing or its financial condition and liquidity; Organon’s ability to meet its revenue and growth expectations and outlook; unfavorable publicity and media reports; the potential impact that actions by activist stockholders could have on the pursuit of our business strategies; the loss of key personnel or highly skilled employees; market volatility, downgrades to the U.S. government’s sovereign credit rating or its perceived creditworthiness, changing political or geopolitical conditions, market contraction, boycotts, and sanctions, as well as Organon’s ability to successfully manage uncertainties related to the foregoing; difficulties with performance of third parties Organon 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 us; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; competition from generic products as Organon’s products lose patent protection; any failure by Organon 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 LOE for Atozet™ (ezetimibe and atorvastatin); the success of our efforts to adapt our business and sales strategies to address the changing market and regulatory landscape in order to achieve our business objectives and remain “competitive;” restructurings or other disruptions at the U.S. Food and Drug Administration (“FDA”), the SEC and other U.S. and comparable government agencies; difficulties and uncertainties inherent in the implementation of Organon’s acquisition strategy or failure to recognize the benefits of such acquisitions; 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 health care reform, pharmaceutical pricing and reimbursement, access to our products, international reference pricing, including Most-Favored-Nation drug pricing, and other pricing-related initiatives and policy efforts; the impact of higher selling and promotional costs; changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, and/or marketing of our products and related intellectual property, environmental regulations, and the enforcement thereof affecting Organon’s business; efficacy, safety or other quality concerns with respect to our marketed products, whether or not scientifically justified, leading to product recalls, withdrawals, labeling changes, or declining sales; delays or failures to demonstrate adequate efficacy and safety of Organon’s product candidates in pre-clinical and clinical trials, which may prevent or delay the development, approval, clearance, or commercialization of Organon’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 health care products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing health care 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 Organon or its third party collaborators and/or their suppliers to fulfill our or their regulatory or quality obligations, which could lead to a delay in regulatory approval or commercial marketing of Organon’s products; cyberattacks on, or other failures, accidents, or security breaches of, Organon’s or third-party providers’ information technology systems, which could disrupt Organon’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 Organon’s business, including recently enacted laws in a majority of states in the United States requiring security breach notification; changes in tax laws including changes related to the taxation of foreign earnings; the impact of any future pandemic, epidemic, or similar public health threat on Organon’s business, operations and financial performance; loss of key employees or inability to identify and recruit new 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 Organon; and volatility of commodity prices, fuel, shipping rates that impact the costs and/or ability to supply Organon’s products. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s filings with the SEC, including the company’s most recent Annual Report on Form 10-K (as amended), Quarterly Reports on Form 10-Q (as amended), Current Reports on Form 8-K, and other SEC filings, available at the SEC’s Internet site (www.sec.gov). TABLE 1 Organon & Co. Condensed Consolidated Statement of Income (Unaudited, $ in millions except shares in thousands and per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Revenues $ 1,602 $ 1,582 $ 4,709 $ 4,811 Cost of sales 745 659 2,137 1,992 Gross Profit 857 923 2,572 2,819 Selling, general and administrative 415 422 1,288 1,290 Research and development 84 111 275 339 Acquired in-process research and development and milestones — 51 6 81 Restructuring costs — — 88 23 Interest expense 128 126 383 388 Exchange losses 17 6 12 11 Other (income) expense, net (30 ) — (53 ) 9 Income before income taxes 243 207 573 678 Income tax expense (benefit) 83 (152 ) 181 (77 ) Net income $ 160 $ 359 $ 392 $ 755 Earnings per share: Basic $ 0.61 $ 1.39 $ 1.51 $ 2.94 Diluted $ 0.61 $ 1.38 $ 1.50 $ 2.92 Weighted average shares outstanding: Basic 259,975 257,498 259,266 256,830 Diluted 260,653 259,757 260,611 258,908 TABLE 2 Organon & Co. Sales by top products (Unaudited, $ in millions) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 ($ in millions) U.S. Int’l Total U.S. Int’l Total U.S. Int’l Total U.S. Int’l Total Women’s Health Nexplanon/Implanon NXT $ 146 $ 77 $ 223 $ 172 $ 70 $ 243 $ 486 $ 225 $ 711 $ 497 $ 207 $ 704 Follistim AQ 24 40 64 26 37 63 89 117 206 59 113 171 NuvaRing 9 17 26 7 17 23 21 54 75 33 57 90 Ganirelix Acetate Injection 3 19 22 5 20 26 10 67 77 16 65 82 Marvelon/Mercilon — 31 31 — 29 29 — 103 103 — 103 103 Jada 20 — 20 15 — 16 53 1 54 42 1 43 Other Women’s Health (1) 17 26 43 14 28 40 47 80 128 41 78 119 General Medicines Biosimilars Renflexis 51 19 70 56 16 72 141 49 190 167 43 210 Hadlima 47 16 63 29 11 40 116 44 159 71 27 98 Ontruzant 4 28 31 5 15 20 12 68 80 23 84 107 Brenzys — 23 23 — 27 27 — 59 59 — 63 63 Other Biosimilars (1) 6 3 9 — 7 7 9 13 22 — 22 22 Cardiovascular Atozet — 95 95 — 125 125 — 257 257 — 396 396 Zetia 1 91 93 2 80 81 4 248 252 5 235 240 Cozaar/Hyzaar 2 53 55 2 57 59 6 160 166 7 179 186 Vytorin 1 25 25 1 25 26 3 72 75 4 78 82 Rosuzet — 6 6 — 11 11 — 16 16 — 36 36 Other Cardiovascular (1) 1 33 33 — 27 29 1 97 98 2 97 99 Respiratory Singulair 2 51 53 2 83 85 6 187 193 7 268 275 Nasonex — 60 60 — 63 63 — 197 197 — 200 200 Dulera 24 10 34 38 10 48 89 28 118 120 31 151 Clarinex 1 25 25 1 26 27 1 92 93 2 97 100 Other Respiratory (1) 9 2 12 11 3 14 32 9 40 26 10 35 Non-Opioid Pain, Bone and Dermatology Arcoxia — 71 71 — 69 69 — 195 195 — 211 211 Fosamax — 40 40 1 37 38 2 106 107 3 109 112 Diprospan — 41 41 — 37 37 — 112 112 — 102 102 Vtama 31 3 34 — — — 80 9 89 — — — Other Non-Opioid Pain, Bone and Dermatology (1) 4 75 80 5 69 74 11 217 229 15 212 227 Other Propecia 2 31 33 2 27 28 4 86 90 5 74 79 Emgality/Rayvow — 51 51 — 29 29 — 125 125 — 69 69 Proscar — 27 27 — 23 23 1 73 73 1 72 73 Other (1) — 86 88 3 80 84 6 245 253 12 229 241 Other (2) 1 21 21 1 26 26 2 66 67 (2 ) 87 85 Revenues $ 406 $ 1,196 $ 1,602 $ 398 $ 1,184 $ 1,582 $ 1,232 $ 3,477 $ 4,709 $ 1,156 $ 3,655 $ 4,811 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 September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Europe and Canada $ 417 $ 436 $ 1,212 $ 1,343 United States 406 398 1,232 1,156 Asia Pacific and Japan 251 260 752 806 China 219 212 627 634 Latin America, Middle East, Russia, and Africa 286 243 810 768 Other (1) 23 33 76 104 Revenues $ 1,602 $ 1,582 $ 4,709 $ 4,811 (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 September 30, Nine Months Ended September 30, 2025 2024 2025 2024 GAAP Gross Profit $ 857 $ 923 $ 2,572 $ 2,819 Adjusted for: Spin-related costs (1) — — — 6 Manufacturing network costs (2) 39 14 101 39 Stock-based compensation 4 4 12 13 Amortization 52 35 155 102 Acquisition-related costs (3) 12 — 31 — Other 2 — 12 — Adjusted Non-GAAP Gross Profit $ 966 $ 976 $ 2,883 $ 2,979 (1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5. (2) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. For additional details refer to Table 5. (3) Acquisition-related costs relate to costs from the acquisition of Dermavant. For additional details refer to Table 5. Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 GAAP Gross Margin 53.5 % 58.3 % 54.6 % 58.6 % Total impact of Non-GAAP adjustments 6.8 % 3.4 % 6.6 % 3.3 % Adjusted Non-GAAP Gross Margin 60.3 % 61.7 % 61.2 % 61.9 % Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 GAAP Selling, general and administrative expenses $ 415 $ 422 $ 1,288 $ 1,290 Adjusted for: Spin-related costs (1) — (10 ) — (79 ) Stock-based compensation (16 ) (17 ) (46 ) (53 ) Restructuring related charges — — (10 ) — Other (5 ) (4 ) (34 ) (4 ) Adjusted Non-GAAP Selling, general and administrative expenses $ 394 $ 391 $ 1,198 $ 1,154 (1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5. TABLE 4 Organon & Co. Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Continued) (Unaudited, $ in millions except per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 GAAP Research and development expenses $ 84 $ 111 $ 275 $ 339 Adjusted for: Spin-related costs (1) — (2 ) — (5 ) Manufacturing network costs (2) (2 ) — (8 ) — Stock-based compensation (4 ) (4 ) (12 ) (13 ) Other (2 ) — (3 ) — Adjusted Non-GAAP Research and development expenses $ 76 $ 105 $ 252 $ 321 (1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5. (2) Manufacturing network related costs include costs from exiting manufacturing and supply agreements with Merck & Co., Inc., Rahway NJ, US. For additional details refer to Table 5. Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 GAAP Reported Net Income $ 160 $ 359 $ 392 $ 755 Adjusted for: Cost of sales adjustments 109 53 311 160 Selling, general and administrative adjustments 21 31 90 136 Research and development adjustments 8 6 23 18 Restructuring — — 88 23 Change in fair value of contingent consideration (32 ) — (9 ) — Other expense (gain), net 4 4 (37 ) 14 Tax impact on adjustments above(1) (7 ) (227 ) (69 ) (276 ) Non-GAAP Adjusted Net Income $ 263 $ 226 $ 789 $ 830 (1) For the three months ended September 30, 2025 and 2024, the GAAP income tax rates were 34.0% and (73.7)%, respectively, and the non-GAAP income tax rates were 25.3% and 24.7%, respectively. For the nine months ended September 30, 2025 and 2024, the GAAP income tax rates were 31.6% and (11.3)%, respectively, and the non-GAAP income tax rates were 24.0% and 19.3%, 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 September 30, Nine Months Ended September 30, 2025 2024 2025 2024 GAAP Diluted Earnings per Share $ 0.61 $ 1.38 $ 1.50 $ 2.92 Total impact of Non-GAAP adjustments 0.40 (0.51 ) 1.53 0.29 Non-GAAP Adjusted Diluted Earnings per Share $ 1.01 $ 0.87 $ 3.03 $ 3.21 TABLE 5 Organon & Co. Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA (Unaudited, $ in millions) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 GAAP Reported Net Income $ 160 $ 359 $ 392 $ 755 Depreciation (1) 37 32 102 93 Amortization 52 35 155 102 Interest expense 128 126 383 388 Income tax expense (benefit) 83 (152 ) 181 (77 ) EBITDA (Non-GAAP) $ 460 $ 400 $ 1,213 $ 1,261 Restructuring and related charges — — 98 23 Spin-related costs (2) — 16 — 104 Manufacturing network related (3) 46 14 118 39 Acquisition-related costs (4) 12 — 31 — Change in contingent consideration (32 ) — (9 ) — Other costs (5) 8 4 3 4 Stock-based compensation 24 25 70 79 Adjusted EBITDA (Non-GAAP) $ 518 $ 459 $ 1,524 $ 1,510 Adjusted EBITDA margin (Non-GAAP) 32.3 % 29.0 % 32.4 % 31.4 % (1) Excludes accelerated depreciation included in one-time costs. (2) Spin-related costs reflect certain costs incurred in connection with activities taken to separate Organon from Merck & Co., Inc., Rahway, NJ, US. These costs include, but are not limited to, $7 million and $47 million for the three and nine months ended September 30, 2024, respectively, for information technology infrastructure, primarily related to the implementation of a stand-alone enterprise resource planning system and redundant software licensing costs, as well as $20 million for the nine months ended September 30, 2024, associated with temporary transition service agreements with Merck & Co., Inc., Rahway, NJ, US. (3) Manufacturing network related costs, including exiting of temporary manufacturing and supply agreements with Merck & Co., Inc., Rahway, NJ, US, reflect accelerated depreciation, exit premiums, technology transfer costs, stability and qualification batch costs, and third-party contractor costs. (4) Acquisition related costs for the three and nine months ended September 30, 2025, reflect the amortization pertaining to the fair value inventory purchase accounting adjustment for the Dermavant transaction. (5) Other costs for the nine months ended September 30, 2025 include $46 million pre-tax gain related to the repurchase and cancellation of approximately $242 million of the 2031 Notes and the repayment and termination of the funding agreement with NovaQuest Co-Investment Fund VIII, L.P. and legal settlement reserves. As the costs described in (1) through (5) above are directly related to the separation of Organon and acquisition related activities and therefore arise from a one-time event outside of the ordinary course of the company’s operations, the adjustment of these items provides meaningful, supplemental, information that the company believes will enhance an investor's understanding of the company's ongoing operating performance.

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.