Atorvastatin Calcium/Ezetimibe

本周药品注册受理数据，分门别类呈现，一目了然。(6.2-6.8）新药上市申请药品名称企业注册分类受理号硫酸索美来昔片浙江杭煜制药有限公司1CXHS2500061赖诺普利氨氯地平片四川尚锐生物医药有限公司2.4CXHS2500062呋喹替尼胶囊和记黄埔医药(上海)有限公司2.4CXHS2500060呋喹替尼胶囊和记黄埔医药(上海)有限公司2.4CXHS250005915价肺炎球菌结合疫苗北京智飞绿竹生物制药有限公司2.1CXSS2500059重组抗IL-1β人源化单克隆抗体注射液三生国健药业(上海)股份有限公司1CXSS2500060注射用维迪西妥单抗荣昌生物制药(烟台)股份有限公司2.2CXSS2500058新药临床申请药品名称企业注册分类受理号注射用HTMC0769上海壹典医药科技开发有限公司1CXHL2500546HSK47977片海思科医药集团股份有限公司1CXHL2500545HSK47977片海思科医药集团股份有限公司1CXHL2500544WJ22096片南京境奥生物医药科技有限公司1CXHL2500543WJ22096片南京境奥生物医药科技有限公司1CXHL2500542HRS-4508片江苏恒瑞医药股份有限公司1CXHL2500541HRS-4508片江苏恒瑞医药股份有限公司1CXHL2500540QL-H118片南京芩领医药科技有限公司1CXHL2500538MDI-1228_mesylate凝胶迈英诺医药科技(珠海)有限公司1CXHL2500531MDI-1228_mesylate凝胶迈英诺医药科技(珠海)有限公司1CXHL2500530HB5凝胶北京中科先行医疗科技有限公司1CXHL2500536HB5凝胶北京中科先行医疗科技有限公司1CXHL2500535HB5凝胶北京中科先行医疗科技有限公司1CXHL2500534XC2309注射液浙江医药股份有限公司新昌制药厂1CXHL2500533D-2570片益方生物科技(上海)股份有限公司1CXHL2500529SN007干混悬剂上海惠永制药有限公司2.2CXHL2500539注射用硼[10B]法仑中子科学(重庆)研究院有限公司2.2CXHL2500532ZK062南京正科医药股份有限公司2.2CXHL2500528注射用多西他赛(白蛋白结合型)石药集团中奇制药技术(石家庄)有限公司2.4CXHL2500537注射用SSS50沈阳三生制药有限责任公司1CXSL2500458注射用LM-24C5礼新医药科技(上海)有限公司1CXSL2500457HJY-ATRQβ-001注射液武汉华纪元生物技术开发有限公司1CXSL2500463注射用SHR-A1811苏州盛迪亚生物医药有限公司1CXSL2500455UC101 CAR-T细胞注射液成都优赛诺生物科技有限公司1CXSL2500451LYN101注射液上海才致药成生物科技有限公司1CXSL2500456TI-0093注射液圆因(北京)生物科技有限公司1CXSL2500461KM1溶瘤痘苗病毒注射液深圳市华药康明生物药业有限责任公司1CXSL2500446SIBP-A10注射液上海生物制品研究所有限责任公司1CXSL2500449注射用DXC018杭州多禧生物科技有限公司1CXSL2500444替雷利珠单抗注射液广州百济神州生物制药有限公司2.1CXSL2500447贝伐珠单抗注射液苏州盛迪亚生物医药有限公司2.2CXSL2500450阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2500448司普奇拜单抗注射液成都康诺行生物医药科技有限公司2.2CXSL2500454仿制药申请药品名称企业注册分类受理号盐酸异丙肾上腺素注射液江苏迪赛诺制药有限公司3CYHS2502023盐酸异丙肾上腺素注射液江苏迪赛诺制药有限公司3CYHS2502022叶酸注射液北京远方通达医药技术有限公司3CYHS2502020叶酸注射液北京远方通达医药技术有限公司3CYHS2502019比拉斯汀口服溶液嘉亨(珠海横琴)医药科技有限公司3CYHS2502018盐酸溴己新口服溶液湖南九典制药股份有限公司3CYHS2502016维生素K1注射液成都苑东生物制药股份有限公司3CYHS2502012硝普钠注射液河北一品制药股份有限公司3CYHS2502011碳酸司维拉姆干混悬剂山东百诺医药股份有限公司3CYHS2502009乙酰半胱氨酸片江西迪赛诺医药集团有限公司3CYHS2502008唑来膦酸注射液广东大翔制药有限公司3CYHS2502005米诺地尔搽剂山东朗诺制药有限公司3CYHS2502003米诺地尔搽剂山东朗诺制药有限公司3CYHS2502002西格列汀二甲双胍缓释片寿光富康制药有限公司3CYHS2501999多种微量元素注射液(I)成都欣捷高新技术开发股份有限公司3CYHS2501992联苯苄唑溶液浙江致新医药科技有限公司3CYHS2501987对乙酰氨基酚布洛芬片哈尔滨三联药业股份有限公司3CYHS2501980注射用头孢噻肟钠/氯化钠注射液湖南科伦制药有限公司3CYHS2501998注射用头孢噻肟钠/氯化钠注射液湖南科伦制药有限公司3CYHS2501997硝普钠注射液山东齐都药业有限公司3CYHS2501982硝普钠注射液山东齐都药业有限公司3CYHS2501981注射用氢化可的松琥珀酸钠沐源(安徽)药业有限公司3CYHS2501975注射用氢化可的松琥珀酸钠沐源(安徽)药业有限公司3CYHS2501974吡格列酮二甲双胍片浙江众延医药科技有限公司3CYHS2501972碳酸司维拉姆干混悬剂福建博悦医药科技有限公司3CYHS2501966米诺地尔搽剂江苏福邦药业有限公司3CYHS2501965布比卡因脂质体注射液浙江海昶生物医药技术有限公司3CYHS2501973枸橼酸托法替布缓释片北大医药股份有限公司4CYHS2502027恩格列净片德州博诚制药有限公司4CYHS2502026恩格列净片德州博诚制药有限公司4CYHS2502025氧韩城市红光制气有限责任公司4CYHS2502024玻璃酸钠滴眼液广州大光制药有限公司4CYHS2502021甲钴胺片河北宏鑫堂药业有限公司4CYHS2502017磷酸奥司他韦胶囊石家庄四药有限公司4CYHS2502015磷酸奥司他韦胶囊石家庄四药有限公司4CYHS2502014乙酰半胱氨酸注射液舒美奇成都生物科技有限公司4CYHS2502013硫酸氨基葡萄糖胶囊山东百诺医药股份有限公司4CYHS2502010利那洛肽胶囊苏州二叶制药有限公司4CYHS2502007唑来膦酸注射液广东大翔制药有限公司4CYHS2502006盐酸氨溴索注射液中国大冢制药有限公司4CYHS2502004地拉罗司分散片河北天成药业股份有限公司4CYHS2502001乙酰半胱氨酸注射液浙江昂利康制药股份有限公司4CYHS2502000盐酸羟考酮缓释片江苏恩华药业股份有限公司4CYHS2501993二十碳五烯酸乙酯软胶囊北京斯利安药业有限公司4CYHS2501995佩玛贝特片南京海鲸药业股份有限公司4CYHS2501994依折麦布阿托伐他汀钙片(I)华润赛科药业有限责任公司4CYHS2501991依折麦布阿托伐他汀钙片(II)华润赛科药业有限责任公司4CYHS2501990甲磺酸沙非胺片宁波美诺华天康药业有限公司4CYHS2501989甲磺酸沙非胺片宁波美诺华天康药业有限公司4CYHS2501988棕榈酸帕利哌酮注射液丽珠集团丽珠制药厂4CYHS2501986棕榈酸帕利哌酮注射液丽珠集团丽珠制药厂4CYHS2501985棕榈酸帕利哌酮注射液丽珠集团丽珠制药厂4CYHS2501984依西美坦片浙江亚瑟医药有限公司4CYHS2501983非洛地平缓释片河北爱普制药有限公司4CYHS2501996乙酰半胱氨酸注射液西藏诺泽生物医药有限公司4CYHS2501979左氧氟沙星滴眼液合肥华威药业有限公司4CYHS2501971盐酸氨溴索口服溶液广东南国药业有限公司4CYHS2501970盐酸氨溴索口服溶液广东南国药业有限公司4CYHS2501969阿达帕林过氧苯甲酰凝胶北京普祺医药科技股份有限公司4CYHS2501968阿达帕林过氧苯甲酰凝胶北京普祺医药科技股份有限公司4CYHS2501967他达拉非片浙江永太药业有限公司4CYHS2501964他达拉非片浙江永太药业有限公司4CYHS2501963尼可地尔片国药集团容生制药有限公司4CYHS2501962甲磺酸沙非胺片成都明德至远医药科技有限公司4CYHS2501961甲磺酸沙非胺片成都明德至远医药科技有限公司4CYHS2501960达格列净片重庆科瑞南海制药有限责任公司4CYHS2501959达格列净片重庆科瑞南海制药有限责任公司4CYHS2501958达格列净片合肥合源药业有限公司4CYHS2501978达格列净片合肥合源药业有限公司4CYHS2501977甲磺酸贝舒地尔片浙江华义制药有限公司4CYHS2501976盐酸毛果芸香碱滴眼液浙江莎普健康管理有限公司3CYHL2500107维生素D口服溶液厦门紫旭医药科技有限公司3CYHL2500105利多卡因丙胺卡因牙周凝胶深圳珐玛易药品科技有限公司3CYHL2500103布地奈德福莫特罗吸入粉雾剂(II)珠海瑞思普利医药科技有限公司4CYHL2500106多种油脂肪乳注射液(C6-24)成都国为生物医药有限公司4CYHL2500104流感病毒裂解疫苗武汉生物制品研究所有限责任公司3.3CXSL2500460流感病毒裂解疫苗武汉生物制品研究所有限责任公司3.3CXSL2500459度普利尤单抗注射液石药集团巨石生物制药有限公司3.3CXSL2500453度普利尤单抗注射液石药集团巨石生物制药有限公司3.3CXSL2500452SAL023注射液信立泰(苏州)药业有限公司3.3CXSL2500445进口申请药品名称企业注册分类受理号替尔泊肽注射液Eli Lilly Nederland B.V.5.1JXHS2500064替尔泊肽注射液Eli Lilly Nederland B.V.5.1JXHS2500063替尔泊肽注射液Eli Lilly Nederland B.V.5.1JXHS2500062替尔泊肽注射液Eli Lilly Nederland B.V.5.1JXHS2500061Clesrovimab注射液Merck Sharp & Dohme B.V.1JXSS2500071帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500073帕博利珠单抗注射液(皮下注射)Merck Sharp & Dohme B.V.2.1JXSS2500072Quabodepistat片Otsuka Pharmaceutical Co., Ltd.1JXHL2500130JSB462片Novartis Pharma AG1JXHL2500129JSB462片Novartis Pharma AG1JXHL2500128TAR-210Janssen Research & Development, LLC2.2;2.4JXHL2500125镥(177Lu)vipivotide tetraxetan注射液Novartis Pharma AG2.4JXHL2500127BMS-986165片Bristol-Myers Squibb Company2.4JXHL2500124BMS-986165片Bristol-Myers Squibb Company2.4JXHL2500123用于制备放射性药物镓(68Ga)gozetotide注射液的药盒Novartis Europharm Limited5.1JXHL2500126中药相关申请药品名称企业注册分类受理号益胃消瘀颗粒重庆市中药研究院(重庆市中药博物馆)1.1CXZL2500037复方黄杞颗粒浙江九如医药科技有限公司1.1CXZL2500036黄厚止泻滴丸安徽雷允上药业有限公司2.3CXZL2500035苓桂术甘颗粒神威药业集团有限公司3.1CXZS2500024注：绿色字体部分为潜在首仿品种；不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

Guidance ranges for full year 2025 revenue and Adjusted EBITDA margin are affirmed; company expects to generate over $900 million of free cash flow before one-time costs in 2025 Vtama on track to achieve $150 million revenue target for full year 2025; double-digit growth in Nexplanon in the first quarter Company resets capital allocation priorities to accelerate progress towards deleveraging; new annual regular dividend rate of $0.08 per share First quarter 2025 revenue of $1.513 billion, down 7% as-reported and down 4% at constant currency, consistent with company’s expectations First quarter 2025 diluted earnings per share of $0.33 and non-GAAP Adjusted diluted earnings per share of $1.02 First quarter 2025 net income of $87 million and Adjusted EBITDA (non-GAAP) of $484 million, representing an Adjusted EBITDA margin of 32.0% JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon (NYSE: OGN) today announced its results for the first quarter ended March 31, 2025. “We have reset our capital allocation priorities to accelerate progress towards deleveraging, enabling a path to achieve a net leverage ratio of below 4.0x by year-end. Over the last year, we have established a leaner, more fit-for-purpose cost structure while increasing revenue contribution from our core growth drivers. By deleveraging more rapidly, we will continue to strengthen the future prospects of the company. Over time, this will position us to execute more of the compelling business development we’ve done to date, bringing in additional growth drivers to our portfolio, while maintaining lower leverage,” said Kevin Ali, Organon’s CEO. “With key growth drivers, Nexplanon and Vtama, on track to achieve their revenue objectives for the year, we are affirming our full year revenue and Adjusted EBITDA margin guidance, as well as our target of generating over $900 million of free cash flow before one-time costs.” First Quarter 2025 Revenue in $ millions Q1 2025 Q1 2024 VPY VPY ex-FX Women’s Health $ 463 $ 422 10 % 12 % Biosimilars 141 170 (17 )% (15 )% Established Brands 887 1,001 (11 )% (8 )% Other (1) 22 29 (23 )% (19 )% Revenue $ 1,513 $ 1,622 (7 )% (4 )% 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 2025, total revenue was $1.513 billion, down 7% on an as-reported basis and down 4% year-over-year excluding the impact of foreign currency (ex-FX). Women’s Health revenue increased 10% as-reported and 12% ex-FX in the first quarter of 2025, compared with the first quarter of 2024. Nexplanon® (etonogestrel implant) growth of 14% ex-FX, as well as a favorable year-over-year comparison in Follistim AQ® (follitropin beta injection) related to the exit of a spin-related interim operating model agreement in the United States, together more than offset a 41% ex-FX decline in NuvaRing® (etonogestrel / ethinyl estradiol vaginal ring) attributable to ongoing generic competition. Biosimilars revenue declined 17% as-reported and 15% ex-FX in the first quarter of 2025, compared with the first quarter of 2024, primarily due to the return to normalized levels of the contracted volume of Ontruzant® (trastuzumab-dttb) in Brazil, a 17% ex-FX decline in Renflexis® (infliximab-abda) attributable to competitive pricing pressure in the U.S. associated with the maturity of the product, and the timing of international tenders for Brenzys™ (etanercept). Performance was partially offset by sales of Hadlima® (adalimumab-bwwd) that have continued to ramp up since its July 2023 launch in the U.S. Established Brands revenue declined 11% as-reported and 8% ex-FX in the first 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 and lower sales of Singulair® (montelukast), particularly in China and Japan. (1) Organon acquired certain European licensing and distribution rights to Emgality and Rayvow from 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. First Quarter 2025 Profitability in $ millions, except per share amounts Q1 2025 Q1 2024 VPY Revenues $ 1,513 $ 1,622 (7 )% Cost of sales 672 665 1 % Gross profit 841 957 (12 )% Non-GAAP Adjusted gross profit (1) 934 1,007 (7 )% Net income 87 201 (57 )% Non-GAAP Adjusted net income (1) 265 315 (16 )% Diluted Earnings per Share (EPS) 0.33 0.78 (58 )% Non-GAAP Adjusted diluted EPS (1) 1.02 1.22 (16 )% Acquired in-process research & development (IPR&D) and milestones 6 15 — % Adjusted EBITDA (Non-GAAP) (1, 2) 484 538 (10 )% Q1 2025 Q1 2024 Gross margin 55.6 % 59.0 % Non-GAAP Adjusted gross margin (1) 61.7 % 62.1 % Adjusted EBITDA margin (Non-GAAP) (1, 2) 32.0 % 33.2 % (1) See Tables 4 and 5 for reconciliations of GAAP to non-GAAP financial measures. (2) Adjusted EBITDA and Adjusted EBITDA margin for 2025 and 2024 include $6 million and $15 million, respectively, related to acquired IPR&D and milestones. Gross margin was 55.6% as-reported and 61.7% on a non-GAAP adjusted basis in the first quarter of 2025, compared with 59.0% as-reported and 62.1% on a non-GAAP adjusted basis in the first quarter of 2024. Lower reported gross margin in the first quarter was due to higher year-over-year amortization expense related to the acquisition of intangibles in the prior year. The year-over-year decline in non-GAAP Adjusted gross margin was primarily due to unfavorable price. Net income for the first quarter of 2025 was $87 million, or $0.33 per diluted share, compared with $201 million, or $0.78 per diluted share, in the first quarter of 2024. For the first quarter of 2025, non-GAAP Adjusted net income was $265 million, or $1.02 per diluted share, compared with $315 million, or $1.22 per diluted share, in 2024. Non-GAAP Adjusted EBITDA margin was 32.0% in the first quarter of 2025 compared with 33.2% in the first quarter of 2024. The lower Adjusted EBITDA margin was primarily driven by the decline in Adjusted gross profit; non-GAAP operating expenses were down 1% year-over-year. 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. This is a revision from the company's prior quarterly dividend rate of $0.28 per share. The dividend is payable on June 12, 2025, to stockholders of record at the close of business on May 12, 2025. As of March 31, 2025, cash and cash equivalents were $547 million, and debt was $8.96 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 February 13, 2025 Current Guidance Revenue $6.125B-$6.325B Unchanged FX translation headwind ~$200M Unchanged, but with potential upside at current rates Adjusted gross margin 60.0%-61.0% Unchanged SG&A Mid 20% range Unchanged R&D Upper single-digit Unchanged IPR&D* - $6 million Adjusted EBITDA margin (Non-GAAP) 31.0%-32.0% Unchanged 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 IPR&D expense in current guidance reflects IPR&D expense recorded through March 31, 2025. Webcast Information Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its first 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 must register in advance by clicking on this link: https://registrations.events/direct/Q4I585113 Following registration, participants will receive a confirmation email containing details on how to join the conference call, including dial-in information and a unique passcode and registrant ID. Pre-registration will allow participants to bypass an operator and be placed directly into the call. About Organon Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers over 70 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical partners and innovators looking to commercialize their products by leveraging its scale and agile presence in fast growing international markets. Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. For more information, visit https://www.organon.com and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) 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 future financial performance and prospects, including expectations regarding regulatory approvals (including the timing and outcome thereof) and product launch dates, potential benefits of Organon’s non-U.S. manufacturing locations, full-year 2025 guidance estimates and predictions regarding other financial information and metrics, expectations regarding Organon’s collaborations with third parties, and franchise and product performance and strategy expectations for future periods. Forward-looking statements may be identified by words such as “guidance,” potential,” “should,” “continue,” “will,” “continue,” “expects,” “intends,” “plans,” “believes,” “future,” “estimates,” “opportunity,” “path,” 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; 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; 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 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; restructurings or other disruptions at the U.S. Food and Drug Administration (“FDA”), the U.S. Securities and Exchange Commission (“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 Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; 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 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 and subsequent 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 March 31, 2025 2024 Revenues $ 1,513 $ 1,622 Cost of sales 672 665 Gross Profit 841 957 Selling, general and administrative 420 431 Research and development 96 112 Acquired in-process research and development and milestones 6 15 Restructuring costs 86 23 Interest expense 124 131 Exchange (gains) losses (4 ) 6 Other expense, net 12 3 Income before income taxes 101 236 Income tax expense 14 35 Net income $ 87 $ 201 Earnings per share: Basic $ 0.34 $ 0.78 Diluted $ 0.33 $ 0.78 Weighted average shares outstanding: Basic 257,862 255,695 Diluted 261,001 258,362 TABLE 2 Sales by top products (Unaudited, $ in millions) Three Months Ended March 31, 2025 2024 ($ in millions) U.S. Int’l Total U.S. Int’l Total Women’s Health Nexplanon/Implanon NXT $ 176 $ 72 $ 248 $ 153 $ 67 $ 220 Follistim AQ 35 34 69 11 35 46 NuvaRing 6 16 22 16 22 38 Ganirelix Acetate Injection 5 23 27 6 23 29 Marvelon/Mercilon — 39 39 — 33 33 Jada 15 — 15 13 — 13 Other Women’s Health (1) 15 27 43 15 28 43 Biosimilars Renflexis 44 12 57 55 14 69 Hadlima 33 14 47 22 8 30 Ontruzant 4 14 18 8 31 39 Brenzys — 14 14 — 24 24 Aybintio — 5 5 — 8 8 Established Brands Cardiovascular Atozet — 77 77 — 132 132 Zetia 1 84 85 2 82 84 Cozaar/Hyzaar 2 53 55 3 65 67 Vytorin 1 22 23 1 27 28 Rosuzet — 4 4 — 16 16 Other Cardiovascular (1) — 30 30 — 37 38 Respiratory Singulair 2 72 74 2 95 98 Nasonex — 71 72 — 77 77 Dulera 34 10 43 43 13 56 Clarinex — 34 34 1 36 37 Other Respiratory (1) 10 3 13 7 3 9 Non-Opioid Pain, Bone and Dermatology Arcoxia — 62 62 — 75 75 Fosamax 1 32 33 1 38 40 Diprospan — 30 30 — 29 29 Vtama 20 4 24 — — — Other Non-Opioid Pain, Bone and Dermatology (1) 4 65 68 5 68 72 Other Propecia 1 24 26 2 21 23 Emgality/Rayvow — 32 32 — 10 10 Proscar — 24 24 — 26 26 Other (1) 3 76 78 5 79 84 Other (2) — 22 22 — 29 29 Revenues $ 412 $ 1,101 $ 1,513 $ 371 $ 1,251 $ 1,622 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, 2025 2024 Europe and Canada $ 376 $ 450 United States 412 371 Asia Pacific and Japan 251 287 China 204 206 Latin America, Middle East, Russia, and Africa 240 274 Other (1) 30 34 Revenues $ 1,513 $ 1,622 (1) Other includes manufacturing sales to third parties. Organon & Co. Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Unaudited, $ in millions) Three Months Ended March 31, 2025 2024 GAAP Gross Profit $ 841 $ 957 Adjusted for: Spin-related costs (1) — 3 Manufacturing network costs (2) 29 10 Stock-based compensation 4 4 Amortization 50 33 Acquisition-related costs (3) 9 — Other 1 — Adjusted Non-GAAP Gross Profit $ 934 $ 1,007 (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 March 31, 2025 2024 GAAP Gross Margin 55.6 % 59.0 % Total impact of Non-GAAP adjustments 6.1 % 3.1 % Adjusted Non-GAAP Gross Margin 61.7 % 62.1 % Three Months Ended March 31, 2025 2024 GAAP Selling, general and administrative expenses $ 420 $ 431 Adjusted for: Spin-related costs (1) — (40 ) Stock-based compensation (16 ) (18 ) Restructuring related charges (6 ) — Other (3 ) — Adjusted Non-GAAP Selling, general and administrative expenses $ 395 $ 373 (1) Spin-related costs include costs from the separation of Merck & Co., Inc., Rahway, NJ, US. For additional details refer to Table 5. Organon & Co. Reconciliation of GAAP Reported to Non-GAAP Adjusted Metrics (Continued) (Unaudited, $ in millions except per share amounts) Three Months Ended March 31, 2025 2024 GAAP Research and development expenses $ 96 $ 112 Adjusted for: Spin-related costs (1) — (2 ) Manufacturing network costs (2) (3 ) — Stock-based compensation (4 ) (4 ) Other (1 ) — Adjusted Non-GAAP Research and development expenses $ 88 $ 106 (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 March 31, 2025 2024 GAAP Reported Net Income $ 87 $ 201 Adjusted for: Cost of sales adjustments 93 50 Selling, general and administrative adjustments 25 58 Research and development adjustments 8 6 Restructuring 86 23 Change in fair value of contingent consideration 11 — Other expense, net 4 4 Tax impact on adjustments above(1) (49 ) (27 ) Non-GAAP Adjusted Net Income $ 265 $ 315 (1) For the three months ended March 31, 2025 and 2024, the GAAP income tax rates were 13.4% and 14.7%, respectively, and the non-GAAP income tax rates were 19.2% and 16.4%, 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, 2025 2024 GAAP Diluted Earnings per Share $ 0.33 $ 0.78 Total impact of Non-GAAP adjustments 0.69 0.44 Non-GAAP Diluted Earnings per Share $ 1.02 $ 1.22 Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA (Unaudited, $ in millions) Three Months Ended March 31, 2025 2024 GAAP Reported Net Income $ 87 $ 201 Depreciation (1) 32 30 Amortization 50 33 Interest expense 124 131 Income tax expense 14 35 EBITDA (Non-GAAP) $ 307 $ 430 Restructuring and related charges 92 23 Spin-related costs (2) — 49 Manufacturing network related (3) 36 10 Acquisition-related costs (4) 9 — Change in contingent consideration 11 — Other costs 5 — Stock-based compensation 24 26 Adjusted EBITDA (Non-GAAP) $ 484 $ 538 Adjusted EBITDA margin (Non-GAAP) 32.0 % 33.2 % (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, $21 million for the three months ended March 31, 2024, 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 $14 million for the three months ended March 31, 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 months ended March 31, 2025, reflect the amortization pertaining to the fair value inventory purchase accounting adjustment for the Dermavant transaction. As the costs described in (1) through (4) 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.