Benvitimod

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.

iStock, juliannafunk Some of the biggest SPACs from the industry’s pandemic-fueled heyday are no longer on the market. 2021 was a wild year for the biotech public stock market. Across the U.S. and Europe, more than 100 startups went for their initial public offerings while another large batch took a different track—merging with a special purpose acquisition company, also known as the SPAC track. Also called blank-check companies, SPACs work by raising capital via an IPO that they then let sit in trust accounts. Eventually, SPACs can leverage this funding to merge with a promising private company in a deal that not only brings the target company to the public stock market but infuses it with a hefty sum of money. During the heyday of 2021—when the industry was flush with pandemic-driven investments—SPACs presented a quick and comparatively easy way to raise money and go public. SPACs typically come with lower upfront costs than traditional initial public offerings (IPOs) and allow companies to collect even more capital through private investment in public equity (PIPE) placements. IPOs, on the other hand, take longer to complete and are burdened by upfront underwriting and legal fees. But the market has since cooled and contracted . With investors driven away by macro-level uncertainties, dozens of companies have already closed shop while many more are in a precarious position . In this piece, BioSpace checks in on some standout SPACs of 2021, looking at how they’ve fared over the years, and how they’re weathering the current market turbulence. Roivant SPAC Date: October 2021 Value: $611 million Roivant debuted on Nasdaq on Oct. 1, 2021 , via a merger with Montes Archimedes Acquisition Corp. The deal gave the burgeoning biotech access to the blank-check company’s $411 million trust fund and $200 million in a PIPE placement. All told, the SPAC deal put Roivant’s cash position at around $2.5 billion . Roivant has used this money to step-up its subsidiary strategy—forming nimble and focused “ Vants ” dedicated to developing novel therapies. Months after completing its SPAC, for instance, the biotech teamed up with Pfizer and in June 2022 launched Priovant Therapeutics to advance brepocitinib, an orally available and selective TYK2 and JAK1 inhibitor for the treatment of autoimmune disorders such as systemic lupus erythematosus and dermatomyositis. Later that year, Roivant and Pfizer debuted another Vant , this time to work on an anti-TL1A antibody for ulcerative colitis. The subsidiary, dubbed Telavant, was acquired by Roche in October 2023 for $7.1 billion upfront . Also in 2022, Roivant scored its first FDA approval for Dermavant’s VTAMA cream, indicated for plaque psoriasis in adults. Two years later, in September 2024, Organon acquired Dermavant in a potential $1.2 billion agreement. That same month, Roivant launched another subsidiary , called Pulmovant, tasked with working on mosliciguat, an inhalable therapy for pulmonary hypertension associated with interstitial lung disease. Since debuting, Roivant’s shares have increased 28% with a market cap of $8.36 billion. EQRx SPAC Date: August 2021 Value: $1.8 billion EQRx launched in 2020 with $200 million in series A money and a lofty goal: change the drug discovery process to develop medicines that are more affordable. In August 2021, CM Life Sciences III, Inc threw its weight behind this mission with a hefty SPAC deal , not only carrying EQRx to the public stock exchange but also providing a $1.8 billion cash infusion. The problems started over a year later, in November 2022, when development plans for the PD-L1 blocker sugemalimab hit a rough patch. In talks with the FDA, EQRx was told that interim findings from its Phase III GEMSTONE-302 trial, conducted in China, would not be enough to support a regulatory filing for U.S. approval. The company at the time decided that there was “no commercially viable path” for sugemalimab in the U.S. EQRx was forced to abandon plans for a test in stage IV non-small cell lung cancer. A few months later, in February 2023, in an effort to “increase . . . operational efficiencies and streamline expenses,” EQRx downsized by 18% , a move that the company expected to generate $18 million in annualized savings. The company ramped up the restructuring process in May that same year with a sweeping business reset , laying off half its headcount and junking another cancer asset. Most notably, EQRx shifted focus to become a more cookie-cutter drug development company, “developing clinically differentiated, high-value medicines,” then-CEO Melanie Nallicheri said in a statement at the time. But even this pivot failed to turn EQRx’s business around. In August 2023, EQRx was absorbed by Revolution Medicines and is no longer trading on Nasdaq. 23andMe SPAC Date: June 2021 Value: $592 million The last few months have been difficult for DNA testing company 23andMe. In March, the company filed for Chapter 11 bankruptcy , seeking for court supervision as it sells its business. This is a far cry from four years earlier, when 23andMe debuted on the public stock market in a SPAC deal with VG Acquisition Corp in June 2021. The agreement raised a gross of $592 million for the consumer genetics company and bumped up its value to $3.5 billion . Shortly after landing on Nasdaq, 23andMe hit its peak market value of approximately $6 billion . Things soon went south, however, as 23andMe struggled to cope with rising interest rates and sales slumps. By the end of fiscal year 2022, the company hit a $184 million net loss , which ballooned to $312 million in 2023 . To stanch the cash bleed, 23andMe in November 2024 put in motion a sweeping restructuring initiative , involving a 40% layoff and a pivot away from drug development efforts. The company at the time expected these measures to generate $35 million in savings annually. Aside from a capital crunch, 23andMe was beset with privacy problems. In October 2023, hackers breached the company’s system and were able to access data of some 6.9 million people. In June this year, 23andMe and its sale were at the heart of a Senate Oversight Committee hearing that highlighted “serious national security” concerns over Americans’ genetic data. That same month, the company was finally acquired for $305 million by the nonprofit TTAM Research Institute, owned by Anne Wojcicki, 23andMe’s former CEO. Wojcicki has pledged to comply with 23andMe’s privacy policies and has made “binding commitments” to add certain safeguards to further protect customers and their genetic data. After being bought by TTAM, 23andMe is no longer on the public stock market. Tango Therapeutics SPAC Date: August 2021 Value: $342 million Tango Therapeutics danced into the public stock market almost four years ago when it merged with BCTG Acquisition Corp. The deal gave the Massachusetts-based biotech $342 million, including $156 million from BCTG’s trust account and roughly $186 million from a PIPE placement. At the time of its Nasdaq debut, Tango’s cash position was at $515 million. In the years since, the biotech has worked on its pipeline of precision cancer therapies, though this effort has not been without its stumbles. In May 2024, Tango shelved the USP1 inhibitor TNG348, which was being testing in early-stage studies for solid tumors. The decision to scrap the asset was driven by grade 3 and 4 liver function abnormalities, which Tango detected in patients who had been on the trial for more than eight weeks. Tango planned to assess TNG348 as a monotherapy and as part of a combination regimen with AstraZeneca and Merck’s PARP inhibitor Lynparza, though the company never had the chance . A few months later, in November 2024, Tango was forced to abandon another asset, this time the PRMT5 blocker TNG908. The molecule, designed to get past the blood-brain barrier, was being trialed for glioblastoma, but a Phase I/II study showed that TNG908 “did not meet the pharmacokinetic exposure threshold for clinical efficacy,” according to a company announcement at the time. Discontinuing TNG908 allowed Tango to fully resource its other PRMT5 blocker TNG462, which is now the biotech’s lead asset. The company is developing the asset for pancreatic and lung cancers, as well as other non-CNS malignancies. Phase I/II data are expected later this year, according to Tango’s most recent quarterly report , released last month, after which it expects to launch a registrational trial for pancreatic cancer next year. Since going public, Tango’s stocks have declined 33%. The biotech has a market cap of $745.4 million. Cerevel Therapeutics SPAC Date: July 2020 Value: $440 million Cerevel was a little early to the SPAC party as compared to the other entries on this list, merging in July 2020 with blank-check firm Arya Sciences Acquisition Corp II. The SPAC at the time had $150 million in trust, which Cerevel’s backers—a high-pro including Bain Capital and Pfizer—supplemented with $320 million in a PIPE placement. All told, Cerevel’s public stock debut a few months later was accompanied by a net cash infusion of approximately $440 million . This money helped the Massachusetts biotech establish itself as a leader in the neurology space, anchored by its next-generation antipsychotic schizophrenia drug emraclidine. Phase Ib data published in December 2022 showed that the drug led to “ clinically meaningful and statistically significant improvements ” in positive and negative symptoms after six weeks of treatment, as compared with placebo. These findings, though early, were enough to not only land emraclidine on BioSpace ’s watchlist for neuropsychiatric drugs on August 2023 but also attract the attention of AbbVie. In December that year, the industry giant dropped an eye-watering $8.7 billion to acquire Cerevel, winning emraclidine and the biotech’s rich pipeline of other investigational neuro assets. The bet seemed to pay off quickly, with a Phase III readout in April 2024 showing that its dopamine receptor partial agonist tavapadon elicited significant motor control improvements in patients with Parkinson’s disease. But in November last year, emraclidine returned back-to-back Phase II failures in schizophrenia , delivering a 12% hit to AbbVie’s shares. The pharma has since recalibrated its program for emraclidine and will take the molecule forward as part of an adjunct regimen. AbbVie’s acquisition of Cerevel closed in August 2024 , officially taking the neuro biotech off the public stock exchange just over four years since its debut. Immatics SPAC Date: March 2020 Value: $250 million In two important ways, Immatics’ SPAC journey mirrors that of Cerevel’s: The cancer-focused biotech launched onto the public stock market in 2020, and it did so by merging with an Arya entity. In the case of Immatics, its SPAC was funded by the original Arya Sciences Acquisition Corp., which in March 2020 offered its $148 million trust fund to take the biotech public. The arrangement was completed in July that same year, with Immatics bagging $253 million in total , including proceeds from a PIPE financing. In the years since its Nasdaq debut, Immatics mustered support from many other biopharma companies through partnerships. Chief of these is Bristol Myers Squibb, which in December 2021 paid $150 million upfront and promised up to $770 million in milestones to co-develop the T cell receptor (TCR) bispecific antibody IMA401. Some six months later, in June 2022, BMS doubled down on its commitment to Immatics by paying $60 million to expand their existing arrangement to go after “multiple” off-the-shelf TCR or CAR T programs. Under the expanded contract, Immatics is eligible for up to $700 million per program. In May 2023, BMS exercised its first license option under the Immatics deal, gaining worldwide license to a novel TCR-T product candidate, in turn giving the biotech $15 million in exercise fees. A few months later, the pharma made a $35 million equity investment in Immatics. Aside from BMS, Immatics also struck up an R&D deal with Moderna in September 2023, under which the companies will explore using mRNA technology for the in vivo expression of TCR bispecifics. The collaboration gave Immatics $120 million upfront plus the possibility of more than $1.7 billion in milestones. Since its SPAC, Immatics’ shares have fallen 66%. The company has a market cap of $657 million.