Follitropin Alfa (Merck)

欧加隆（Organon & Co.，NYSE: OGN）是全球唯一以女性健康为核心战略的大型跨国制药公司，2021 年 6 月 3 日从默沙东（MSD）分拆独立上市，总部位于美国新泽西州泽西市，业务覆盖全球 140 + 国家与地区Organon。公司以 “因她而来（Here for her health）” 为使命，聚焦女性全生命周期健康，同时布局生物类似药与成熟品牌药，形成三大核心业务板块Organon。一、公司基本概况1. 历史沿革 1923 年：前身欧加农（Organon）在荷兰成立，欧洲首家胰岛素制造商。 2007 年：被先灵葆雅收购；2009 年随先灵葆雅并入默沙东。 2021 年 6 月：从默沙东分拆，独立于纽交所上市（股票代码：OGN）。 2024 年：全球营收约62 亿美元，中国为其全球第二大市场欧加隆(上海)医药科技有限公司。2. 核心定位与规模 定位：专注女性健康的全球化制药企业，覆盖避孕、生育、更年期、慢病等全周期需求Organon。 产品管线：全球拥有70 + 款上市产品，覆盖 9 大治疗领域欧加隆(上海)医药科技有限公司。 生产布局：在比利时、巴西、印尼、墨西哥、荷兰、英国运营 6 大生产基地。 中国布局：总部上海，5 大办公室（北京 / 上海 / 广州 / 杭州 / 成都），员工超 1100 人，23 款产品覆盖 9 大领域。二、三大核心业务板块（2024 年收入结构）1. 女性健康（Women’s Health，约 27%） 战略核心板块，覆盖女性全生命周期健康需求，是全球女性健康领域领导者。避孕与生育调节 长效可逆避孕：Nexplanon（依伴侬），全球领先的 3 年期皮下植入避孕药，高效、可逆、低维护。 短效口服避孕药：多款复方口服避孕药，满足不同人群需求。 生育辅助：Puregon（果纳芬），促卵泡激素，辅助生殖核心用药。生殖健康与围产期 产后出血管理：Jada 宫内真空止血系统，NMPA 优先审评，用于产后出血急救。 妇科疾病：子宫内膜异位症、子宫肌瘤等治疗药物。更年期与老年女性健康 激素替代疗法（HRT）：缓解潮热、盗汗、骨质疏松等更年期症状。 骨健康：骨质疏松防治药物，聚焦绝经后女性高发骨病。2. 生物类似药（Biosimilars，约 8%） 高增长板块，聚焦肿瘤与自身免疫，提供低价可及的生物药替代方案。 核心产品：Hadlima（阿达木单抗生物类似药），对标修美乐，用于类风湿关节炎、银屑病等。 管线布局：覆盖肿瘤、免疫、炎症等领域，持续拓展生物类似药管线，提升全球可及性。3. 成熟品牌药（Established Brands，约 64%） 现金流支柱，覆盖多治疗领域的经典药物，全球市场稳定贡献收入。 心血管：高血压、高血脂、冠心病等慢病管理药物。 呼吸：哮喘、慢性阻塞性肺疾病（COPD）治疗药物。 中枢神经：抑郁症、精神分裂症、疼痛管理等药物。 皮肤与过敏：皮炎、湿疹、过敏性疾病治疗药物。 其他：男性健康、疼痛、骨健康等领域经典药物欧加隆(上海)医药科技有限公司。三、中国区业务重点 中国是欧加隆全球战略核心，聚焦女性健康 + 成熟品牌双轮驱动欧加隆(上海)医药科技有限公司。女性健康 ：打造从避孕、受孕、分娩到更年期的全周期解决方案，重点推进依伴侬、果纳芬、Jada 止血系统等产品商业化欧加隆(上海)医药科技有限公司。成熟品牌 ：深耕心血管、呼吸、中枢神经等慢病领域，覆盖基层与县域市场，提升药物可及性欧加隆(上海)医药科技有限公司。本土化战略 ：深化研发合作、供应链本土化、基层医疗覆盖，加码中国创新与市场投入。四、核心竞争力与战略方向1. 核心竞争力女性健康赛道唯一性 ：全球唯一以女性健康为核心的大型跨国药企，赛道壁垒高。全生命周期产品矩阵 ：覆盖女性从青春期到老年的全周期健康需求。成熟品牌现金流 ：稳定现金流支撑女性健康与生物类似药创新投入。全球 + 本土双轮驱动 ：全球研发 + 中国本土化运营，适配中国市场需求。2. 未来战略 聚焦女性健康：拓展更年期、妇科肿瘤、女性慢病等未被满足需求。 生物类似药扩张：丰富肿瘤与免疫管线，提升全球市场份额。 中国市场深耕：加大在华研发、生产、商业化投入，巩固第二大市场地位。 创新合作：与本土药企、科研机构合作，加速创新产品落地中国。五、与其他跨国药企的差异化赛道聚焦 ：区别于辉瑞、罗氏等综合药企，唯一以女性健康为核心战略。业务结构 ：成熟品牌提供稳定现金流，反哺女性健康与生物类似药创新。中国定位 ：将中国视为全球第二大市场，深度本土化布局，聚焦基层与女性健康需求。

Company delivered on financial guidance for 2025 Net sales around stable at € 21.1 billion; organic growth of +3.1%; foreign exchange effects of –3.7% EBITDA pre grew to € 6.1 billion; organic growth of +5.6%; foreign exchange effects of –5.0% Executive Board and Supervisory Board propose stable dividend of € 2.20 per share Outlook 2026: Net sales of € 20.0 – 21.1 billion and EBITDA pre of € 5.5 – 6.0 billion amid considerable foreign exchange headwinds Merck KGaA, Darmstadt, Germany, a leading science and technology company, delivered on its guidance for 2025 and achieved organic growth despite significant headwinds. Process Solutions in the Life Science business sector, the Cardiovascular, Metabolism & Endocrinology (CM&E) franchise within Healthcare and the Semiconductor Materials business within Electronics were the main contributors. “We once again demonstrated our resilience in 2025 in the face of significant geopolitical challenges and strong currency headwinds. Our consistent record of disciplined financial performance and sharp strategic focus over the last five years has paid off and made us larger, more profitable, more efficient, more flexible, and less leveraged. I’m very proud of where we stand today,” said Belén Garijo, Chair of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany. “As a diversified global business with a robust portfolio and core growth drivers in Process Solutions, Rare Diseases and Semiconductor Solutions, we are now well positioned for the decade ahead as our company’s next chapter begins.” Financial performance in 2025 In 2025, net sales of the Group grew organically by 3.1% compared with the previous year. Reported net sales declined by 0.3% to € 21.1 billion, mainly driven by a negative impact of –3.7% from foreign exchange effects concerning the U.S. dollar and various Asian currencies. Portfolio effects, especially the acquisition of SpringWorks and the divestment of the Surface Solutions business unit, made a net positive contribution of 0.4%. In the fourth quarter of 2025, net sales grew organically by 2.6%, while reported net sales declined by 3.1% compared with the year-earlier quarter. The company’s full-year EBITDA pre grew organically by 5.6% to € 6.1 billion. Foreign exchange had a negative effect of –5.0% while portfolio effects offset each other at 0.0%. The EBITDA pre margin improved by 0.2 percentage points to 28.9%. In the fourth quarter, reported EBITDA pre was down 3.2% while growing 3.1% organically. For the full year, earnings per share pre were € 8.34 (2024: € 8.63). The Executive Board and Supervisory Board will propose an unchanged dividend of € 2.20 per share to the Annual General Meeting on April 24, 2026. This would mark the fifteenth year in a row with an increasing or stable dividend. Merck KGaA, Darmstadt, Germany agreed with the U.S. administration to expand access to its portfolio of in vitro fertilization therapies in the United States. The company is also filing Pergoveris for expedited review under the U.S. Food and Drug Administration Commissioner’s National Priority Voucher program. Furthermore, the Group has reached an agreement with the U.S. Department of Commerce to be relieved from Section 232 pharmaceutical tariffs and has committed to further invest in the U.S. Outlook for 2026 For 2026, Merck KGaA, Darmstadt, Germany anticipates net sales between € 20.0 billion and € 21.1 billion and EBITDA pre between € 5.5 billion and € 6.0 billion. This corresponds to an organic net sales development of –1% to +2% and an organic EBITDA pre development of –4% to +1%. Foreign exchange effects are expected to have an influence of –4% to –2% on net sales and –7% to –3% on EBITDA pre. Overall, this translates to an expected EPS pre range of € 7.10 to € 8.00. This guidance assumes no U.S. sales of Mavenclad from March 2026 amid generic competition. It also excludes positive effects from a potential U.S. launch of Pergoveris. Life Science: Process Solutions drives return to growth The Process Solutions business unit powered growth in Life Science throughout the year, delivering four consecutive quarters of around 10% organic sales growth. Life Science net sales reached € 9.0 billion, with organic growth of 4.0% and portfolio effects of 0.1% dampened by foreign exchange effects of –3.4%. EBITDA pre remained around stable at € 2.6 billion. Organic growth of 3.9% was impacted by foreign exchange effects of –4.3%. Process Solutions, which markets solutions for the entire pharmaceutical production value chain, grew organically across its entire portfolio and in all regions. This growth was supported by demand for bioprocessing solutions and novel modalities such as antibody-drug conjugates. Driven primarily by higher demand from new customer projects and a normalizing market, net sales in Process Solutions grew organically by 10.7% year-on-year to € 3.8 billion. Order intake remains strong, with the book-to-bill ratio comfortably above 1. The business unit is strategically well positioned to capture market momentum and opportunities arising from the industry’s shift toward biologics. Science & Lab Solutions posted organic growth of 0.3% and positive portfolio effects of 0.2%. These were impacted by foreign exchange effects of –3.4%, resulting in net sales of € 4.5 billion. The business unit’s portfolio comprises products and services for pharmaceutical, biotechnology and academic research. Impacts during the year included the effects of U.S. policy changes and the extended government shutdown on spending by academic and government labs as well as ongoing challenges in the market environment, especially in China. Additionally, early-stage biotech funding remained flat. This resulted in lower demand for laboratory products. Net sales in Life Science Services were impacted by non-repeating business from the previous year and came in at € 659 million in 2025. As of January 1, 2026, Life Science has transformed its business units to align its go-to-market approaches even more closely with specific customer experiences. Healthcare: Rare Diseases franchise underpins growth profile Healthcare had a solid year across franchises, with net sales in the business sector growing organically by 3.7% to € 8.6 billion in fiscal 2025. Portfolio effects from the acquisition of SpringWorks added growth of 2.2% while foreign exchange had an impact of –4.1%. EBITDA pre recorded an organic increase of 11.5%. Negative impacts resulted from foreign exchange effects of –8.5% and a minor portfolio effect of –0.1%. Overall, EBITDA pre increased to € 3.1 billion. The newly established Rare Diseases franchise contributed significantly to the results as of the third quarter of 2025, reflected as a portfolio effect. It includes sales from Ogsiveo, which treats progressing desmoid tumors, and Gomekli/Ezmekly, approved for plexiform neurofibromas associated with neurofibromatosis type 1. Merck KGaA, Darmstadt, Germany gained the worldwide rights for these products following the acquisition of SpringWorks. Together with pimicotinib as a systemic treatment for patients with tenosynovial giant cell tumor, the company’s Rare Diseases franchise is expected to contribute to organic growth throughout 2026. The Cardiovascular, Metabolism & Endocrinology (CM&E) franchise was the largest growth driver in Healthcare, posting organic year-on-year growth of 7.3% across all therapeutic areas. The franchise includes the diabetes medicine Glucophage, the beta-blocker Concor, the thyroid medicine Euthyrox, and Saizen, which is primarily used to treat growth hormone disorders. Net sales in the Neurology & Immunology (N&I) franchise increased by 1.9% organically compared with the previous year. Mavenclad, indicated for relapsing forms of multiple sclerosis, delivered organic growth of 16.6% and net sales of € 1.2 billion. This was driven primarily by increasing demand in North America and Europe. Rebif, also for relapsing forms of multiple sclerosis, saw net sales decline organically by 23.0% as expected. In the Oncology franchise, organic net sales growth was 0.3%. Erbitux, a treatment for metastatic colorectal cancer and for cancer of the head and neck, grew organically by 6.6% amid a challenging competitive environment in China. Due to strong competition, net sales for Bavencio, which is used to treat locally advanced or metastatic urothelial carcinoma, declined organically by 13.8%. Net sales of the Fertility franchise remained around stable, with organic growth of 0.4% in 2025. Gonal-f, a follicle-stimulating hormone treatment for infertility, declined organically by 6.7%. Pergoveris, indicated for the stimulation of follicular development in women, grew organically by 22.6% across all regions. Electronics: Semiconductor Materials delivers sustained growth momentum The artificial intelligence (AI) boom sustained strong demand in Electronics. The Semiconductor Materials business was the business sector’s main growth engine, delivering high single-digit organic growth for the year and the eighth consecutive quarter of strong year-on-year growth. Delivery Systems & Services (DS&S) recorded an organic decline in net sales caused by prolonged delays to large customer projects. This was the main driver behind the 0.6% organic decline in net sales of Electronics in 2025. The divestment of Surface Solutions led to a portfolio effect of –3.2% despite a positive contribution from the acquisition of Unity-SC. Foreign exchange effects were –3.3%. Overall, net sales declined to € 3.5 billion. EBITDA pre decreased 14.1% year-on-year to € 833 million. One-time effects in the second quarter of 2025 and lower sales in DS&S more than offset the growth of Semiconductor Materials. Organic performance decreased by 9.0%. Foreign exchange and portfolio effects had a negative impact of –4.4% and –0.7% respectively. Net sales of Semiconductor Solutions declined organically by 1.4% to € 2.5 billion. Semiconductor Materials achieved strong organic sales growth driven by the demand for high-value materials that enable AI chip systems and advanced nodes. Advanced nodes are the latest semiconductor manufacturing processes that enable smaller feature sizes and the most powerful chips. DS&S recorded a sales decline in the double-digit percentage range. The company expects the business to stabilize in 2026 and to return to growth in the medium term. Optronics delivered net sales of € 772 million. The business unit comprises the businesses with liquid crystals, photoresists for display applications, OLED materials, and metrology and inspection equipment for semiconductor and optoelectronic manufacturing. The overall increase of 3.2% came on the back of organic growth of 0.6% and portfolio effects of 5.8% from the acquisition of Unity-SC. With the divestment of Surface Solutions, which closed at the end of July 2025, Electronics has transformed into a pure-play business with a primary focus on the semiconductor market. Company drives forward science and technology Merck KGaA, Darmstadt, Germany made significant strides in science and technology. In Life Science, the acquisition of HUB Organoids further strengthens its position in next-generation biology. Organoids are a key resource for researchers, leveraging 3D cell cultures to generate earlier, more predictive insights and in turn supporting more informed decisions throughout drug development. Additionally, the partnership with imec is aimed at developing microfluidic devices that simulate the functions of human organs using living cells. This collaboration combines the expertise of Merck KGaA, Darmstadt, Germany in cells and organs with imec’s advanced sensor technology, providing scientists with critical insights into cellular responses to medications. The company also invested € 500 million in its Semiconductor Solutions mega-site in Kaohsiung, Taiwan. This site focuses on semiconductor materials, especially thin films – a technology that allows materials to be deposited and removed on an atomic level, enabling more layers, higher complexity and new chip architectures essential for advanced semiconductors. Regarding its sustainability ambition, Merck KGaA, Darmstadt, Germany exceeded its climate target to halve absolute Scope 1 (direct) and Scope 2 (indirect) greenhouse gas emissions by 2030. The company achieved a 60% reduction compared with the 2020 baseline at the end of 2025 – five years ahead of schedule. This is a major milestone toward the company’s goal of achieving climate neutrality by 2040. Overview of the key figures Group Key figures Change € million 2025 2024 € million % Net sales 21,102 21,156 -54 -0.3% Operating result (EBIT)1 3,601 3,645 -44 -1.2% Margin (% of net sales)1 17.1% 17.2% EBITDA2 5,899 5,779 120 2.1% Margin (% of net sales)1 28.0% 27.3% EBITDA pre1 6,109 6,072 37 0.6% Margin (% of net sales)1 28.9% 28.7% Profit after tax 2,615 2,786 -171 -6.1% Earnings per share (€) 6.00 6.39 -0.39 -6.1% Earnings per share pre (€)1 8.34 8.63 -0.29 -3.4% Operating cash flow 3,932 4,586 -654 -14.3% 1 Not defined by IFRS Accounting Standards. 2 Not defined by IFRS Accounting Standards; EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. Group Net sales by business sector € million 2025 Share Organic growth1 Exchange rate effects1 Acquisitions/ divestments1 Total change 2024 Share Life Science 8,980 42% 4.0% -3.4% 0.1% 0.7% 8,916 42% Healthcare 8,607 41% 3.7% -4.1% 2.2% 1.8% 8,455 40% Electronics 3,515 17% -0.6% -3.3% -3.2% -7.1% 3,785 18% Group 21,102 100% 3.1% -3.7% 0.4% -0.3% 21,156 100% 1 Not defined by IFRS Accounting Standards. Life Science Net sales by business unit € million 2025 Share Organic growth1 Exchange rate effects1 Acquisitions/ divestments1 Total change 20242 Share Science & Lab Solutions 4,536 51% 0.3% -3.4% 0.2% -2.9% 4,672 52% Process Solutions 3,785 42% 10.7% -3.5% 0.3% 7.5% 3,522 40% Life Science Services 659 7% -4.5% -3.4% -0.9% -8.7% 722 8% Life Science 8,980 100% 4.0% -3.4% 0.1% 0.7% 8,916 100% 1 Not defined by IFRS Accounting Standards. 2 Previous-year figures have been adjusted owing to an internal realignment. Healthcare Net sales by major product lines/products € million 2025 Share Organic growth1 Exchange rate effects1 Acquisitions/ divestments1 Total change1 2024 Share Oncology 1,926 22% 0.3% -4.5% – -4.2% 2,009 24% thereof: Erbitux® 1,176 14% 6.6% -5.5% – 1.2% 1,162 14% thereof: Bavencio® 612 7% -13.8% -2.9% – -16.7% 735 9% Rare Diseases 188 3% thereof: Ogsiveo® 134 2% thereof: Gomekli® 55 1% Neurology & Immunology 1,659 19% 1.9% -3.6% – -1.7% 1,688 20% thereof: Mavenclad® 1,194 14% 16.6% -4.1% – 12.4% 1,062 13% thereof: Rebif® 465 5% -23.0% -2.8% – -25.8% 626 7% Fertility 1,457 17% 0.4% -5.1% – -4.6% 1,528 18% thereof: Gonal-f® 735 9% -6.7% -5.0% – -11.7% 833 10% thereof: Pergoveris® 329 4% 22.6% -5.2% – 17.4% 280 3% Cardiovascular, Metabolism & Endocrinology 3,050 35% 7.3% -3.8% – 3.4% 2,949 35% thereof: Glucophage® 975 11% 5.9% -3.7% – 2.3% 954 11% thereof: Concor® 625 7% 4.7% -2.3% – 2.4% 611 7% thereof: Euthyrox® 653 8% 9.4% -3.9% – 5.4% 619 7% thereof: Saizen® 388 5% 13.0% -6.8% – 6.2% 366 4% Other 328 4% 280 3% Healthcare 8,607 100% 3.7% -4.1% 2.2% 1.8% 8,455 100% 1 Not defined by IFRS Accounting Standards. Electronics Net sales by business unit € million 2025 Share Organic growth¹ Exchange rate effects1 Acquisitions/ divestments1 Total change 2024 Share Semiconductor Solutions 2,494 71% -1.4% -3.7% -0.1% -5.2% 2,631 69% Optronics 772 22% 0.6% -3.2% 5.8% 3.2% 748 20% Surface Solutions 249 7% 1.9% -1.3% -39.5% -38.8% 406 11% Electronics 3,515 100% -0.6% -3.3% -3.2% -7.1% 3,785 100% 1 Not defined by IFRS Accounting Standards. Report on expected developments € million Net sales EBITDA pre1 Free cash flow Group • ~20,000 to 21,100 • Organic -1% to +2% • Foreign exchange effect -4% to -2% • Portfolio ~0% • ~5,500 to 6,000 • Organic -4% to +1% • Foreign exchange effect -7% to -3% • Portfolio ~0% • ~1,500 to 2,000 Life Science • ~8,900 to 9,300 • Organic +3% to +6% • Foreign exchange effect -4% to -1% • Portfolio ~0% • ~2,500 to 2,700 • Organic +2% to +6% • Foreign exchange effect -4% to -1% • Portfolio ~+1% Healthcare • ~7,900 to 8,300 • Organic -7% to -4% • Foreign exchange effect -4% to -1% • Portfolio ~+2% • ~2,500 to 2,700 • Organic -14% to -10% • Foreign exchange effect -6% to -3% • Portfolio ~0% Electronics • ~3,200 to 3,400 • Organic +3% to +7% • Foreign exchange effect -5% to -2% • Portfolio ~-7% • ~900 to 1,000 • Organic +21% to +27% • Foreign exchange effect -7% to -4% • Portfolio ~-4% Corporate and Other • ~ -450 1 Not defined by IFRS Accounting Standards; EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. EPS pre € 7.10 to € 8.00, based on an underlying tax rate of 22%. Notes to editors: The press conference for media representatives will take place at 10:00 a.m. CET. The respective presentation and further information for journalists, including a digital press kit, can be found here. The annual report 2025 can be found here. Merck KGaA, Darmstadt, Germany on LinkedIn. Company photos and videos can be found here. Merck KGaA, Darmstadt, Germany stock symbols: Reuters: MRCG, Bloomberg: MRK GY, Dow Jones: MRK.DE Frankfurt Stock Exchange: ISIN: DE 000 659 9905 – WKN: 659 990