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Press Release: Sanofi’s Rezurock recommended for EU approval by the CHMP to treat chronic graft-vs-host disease
Globenewswire· 2026-01-30 12:00
Sanofi’s Rezurock recommended for EU approval by the CHMP to treat chronic graft-vs-host disease Recommendation supported by safety and efficacy results from several clinical studies and real-world evidenceIf approved, Rezurock would offer a new treatment option in the EU for adult patients and in children aged 12 years and older in late line chronic GVHD Paris, January 30, 2026. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending ...
赛诺菲心血管双子星获批:创新BD加速全球新药物首发
Jing Ji Guan Cha Wang· 2026-01-30 06:16
全球最新、最好的创新药物,什么时候能来中国?跨国药企赛诺菲正在用实际行动表明,中国可以是全球新药"第一站"。 2025年12月到2026年1月,短短数周内,赛诺菲连续有两款心血管药物在中国获批。它们分别是全球首发的新药阿夫凯泰片(商品名:星舒平 ),有着同类 最佳潜力,以及全球首创的普乐司兰钠注射液(商品名:瑞达普 ),填补了一处重要疾病领域的治疗空白。 实际上,赛诺菲的"心血管双子星"接连获批,也是与中国合作伙伴深度交融的结果,也是赛诺菲创新的BD(business development,业务拓展)模式的明 证。 2025年,堪称中国创新药BD交易爆发元年。医药魔方数据显示,中国创新药BD出海授权2025年交易总金额达到1356.55亿美元,再创历史新高。 在中国创新药纷纷借船出海时,赛诺菲中国则另辟蹊径。2022年底,总部授权赛诺菲中国引进管线的权力。此后,赛诺菲立足中国,主动深入中国本土创新 药生态,发掘最有潜力的药物分子,凭借自身雄厚的开发和商业化实力,让药物最早惠及中国患者。 2024年末以来,赛诺菲分别通过与箕星药业、维亚臻的BD合作,获得了阿夫凯泰片和普乐司兰钠注射液的大中华区开发及商业化权益 ...
Sanofi Beats on Q4 Earnings, Expects Profitable Growth in 2026
ZACKS· 2026-01-29 17:26
Core Insights - Sanofi reported fourth-quarter 2025 adjusted earnings of 89 cents per American depositary share, exceeding the Zacks Consensus Estimate of 84 cents, with earnings of €1.53 per share reflecting a 16.8% increase on a reported basis and a 26.7% increase on a constant currency rate basis, primarily due to cost control [1] - Net sales increased by 7.0% on a reported basis to $13.2 billion (€11.3 billion), although slightly missing the Zacks Consensus Estimate of $13.4 billion [1][10] Sales Performance - Sales in the United States rose by 22.6% at constant currency, while the Rest of the World saw an 8.0% increase, and Europe experienced a modest growth of 0.2% [2] - Dupixent, a key product in Immunology, generated sales of €4.25 billion, marking a 32.2% year-over-year increase, with U.S. sales rising by 35.9% [3][10] - Altuviiio, a rare disease drug, recorded sales of €324 million, up 53.0% year over year, with 85% of sales coming from the U.S. market [5] - Nexviazyme/Nexviadzyme sales reached €203 million, up 15.8% year over year, while Myozyme sales declined by 5.3% to €122 million [6] Drug and Vaccine Insights - Cablivi sales increased by 1.4% to €69 million, while Eloctate sales fell by 16.0% to €63 million due to patient switches to Altuviiio [7] - Total vaccine sales declined by 2.5% to €2.04 billion, primarily due to lower sales of certain vaccines, although flu vaccine sales rose by 31.5% to €575 million [14][15] - Sanofi's new drugs, Qfitlia and Wayrilz, generated sales of €4 million and €6 million respectively, with both drugs currently only approved in the U.S. [8][9] Future Outlook - Sanofi provided guidance for 2026, expecting high single-digit sales growth at constant currency and earnings growth to outpace sales growth [16] - The company anticipates a stock buyback worth €1 billion in 2026 [16] - Sanofi's stock has seen a decline of 15.6% over the past year, contrasting with an 18.0% increase in the industry [18] M&A Activity - Sanofi announced an agreement to acquire Dynavax Technologies for approximately $2.2 billion, which will enhance its adult vaccines portfolio [20] - The acquisition of Blueprint Medicines last year has expanded Sanofi's presence in rare immunological diseases [20]
Sanofi Edges Higher As Immunology Powerhouse, Dupixent, Wallops Forecasts
Investors· 2026-01-29 17:08
Group 1 - Sanofi reported adjusted earnings of 91 cents per share on $13.5 billion in fourth-quarter sales, exceeding analysts' expectations of 84 cents per share and $13.57 billion in sales [1][1][1] - The company's earnings per share increased from 68 cents in the same period last year, while sales rose from $11.89 billion [1][1][1] Group 2 - Sanofi's stock experienced a slight increase following the earnings report, indicating a positive market reaction to the results [1][1][1]
Sanofi(SNY) - 2025 Q4 - Earnings Call Transcript
2026-01-29 14:32
Financial Data and Key Metrics Changes - In Q4 2025, the company achieved net sales of EUR 11.3 billion, reflecting a growth of 13.3% year-over-year [6][12] - For the full year 2025, total sales reached EUR 43.6 billion, representing a 9.9% growth at constant exchange rates [14] - Business EPS growth was strong at 26.7%, indicating effective operational leverage [12] - Business gross margin expanded by 1.8 percentage points to 77.5%, driven by a favorable product mix and operational efficiencies [14] Business Line Data and Key Metrics Changes - Newly launched medicines and vaccines generated EUR 5.7 billion in sales, with a growth of 34% in 2025 [4][6] - Dupixent sales reached EUR 4.2 billion in Q4 and EUR 15.7 billion for the full year, with over 30% increase in patient numbers [7][8] - Beyfortus sales grew by 9.5% to EUR 1.8 billion, driven by geographic expansion [8][9] Market Data and Key Metrics Changes - The company maintained leadership in influenza and RSV vaccines, with full year sales of EUR 7.9 billion [8] - The U.S. market share for influenza vaccines increased, particularly with Fluzone High-Dose and Flublok [8] - Beyfortus has protected over 11 million babies in more than 45 countries, preventing an estimated 200,000 hospitalizations [9] Company Strategy and Development Direction - The company is transitioning into an R&D-driven, AI-powered biopharma entity, focusing on business development and M&A opportunities [4] - Strategic acquisitions, including Vicebio and Dynavax Technologies, are aimed at enhancing the vaccine portfolio and expanding into older adult demographics [9][10] - The company plans to continue investing in manufacturing capacity to meet growing patient demand [14] Management's Comments on Operating Environment and Future Outlook - Management expects 2026 to deliver profitable growth close to 2025 levels, with high single-digit sales growth anticipated [17][18] - The company is preparing for potential challenges in vaccine sales and is focused on maintaining a stable G&A expense structure [18] - Management highlighted the importance of innovation and collaboration in achieving sustainable healthcare goals [10] Other Important Information - The company completed a EUR 5 billion share buyback program and proposed a 5% increase in dividends for the 31st consecutive year [17] - Free cash flow returned to strong levels at EUR 8.1 billion, representing 18.5% of sales, with a target of reaching at least 20% in the medium term [15] Q&A Session Summary Question: Can you elaborate on the Dupixent rollout and its competition? - Management reported strong performance with 25% year-over-year growth for Dupixent, driven by new indications like CSU and COPD [30][31] Question: What is the growth outlook for Beyfortus in 2026? - Management expressed optimism about Beyfortus performance, noting its availability in over 45 countries and a positive real-world evidence publication [34][36] Question: What are the prospects for Amlitelimab and its market penetration? - Management remains confident in Amlitelimab's potential, emphasizing its novel mechanism and the importance of ongoing data collection [39][41] Question: How is the company addressing the recent changes in the U.S. pediatric vaccination schedule? - Management acknowledged potential confusion but emphasized proactive engagement with healthcare providers to maintain vaccination rates [77][78] Question: What is the strategy for capital allocation moving forward? - Management indicated a dynamic allocation strategy guided by AI, focusing on maximizing value from investments [60]
Sanofi(SNY) - 2025 Q4 - Earnings Call Transcript
2026-01-29 14:32
Sanofi (NasdaqGS:SNY) Q4 2025 Earnings call January 29, 2026 08:30 AM ET Company ParticipantsBen Jackson - VP of Equity ResearchBrian Foard - EVP and Head of Specialty CareDavid Reed Risinger - Senior Managing DirectorFrançois-Xavier Roger - CFOGraham Parry - Managing Director and Head of European Pharmaceuticals Equity researchHouman Ashrafian - EVP and Head of Research and DevelopmentJames Gordon - Director and Head of European Pharma, Biotech & Life Sciences Equity ResearchJames Quigley - Executive Direc ...
Sanofi(SNY) - 2025 Q4 - Earnings Call Transcript
2026-01-29 14:30
Sanofi (NasdaqGS:SNY) Q4 2025 Earnings call January 29, 2026 08:30 AM ET Speaker7Hello everyone, this is Thomas Kudsk Larsen from the Sanofi IR team. Welcome to the Q4 and full year 2025 conference call for investors and analysts. As usual, you can find slides on sanofi.com. Please turn to slide number 3. Here we have the usual forward-looking statements. We would like to remind you that information presented in this call contains forward-looking statements which are subject to substantial risk and uncertai ...
Sanofi(SNY) - 2025 Q4 - Earnings Call Presentation
2026-01-29 13:30
Business Finance Pipeline Appendices Business Finance Pipeline Appendices Results Q4/FY 2025 January 29, 2026 Forward-looking statements This document contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to fu ...
Sanofi vaccine sales face headwinds from US policy shifts
Yahoo Finance· 2026-01-29 12:18
By Bhanvi Satija LONDON, Jan 29 (Reuters) - France's Sanofi, among the world's largest vaccine makers, said on Thursday that its vaccines sales would be "slightly negative" this year, partly due to U.S. policy changes under ​President Donald Trump. Sanofi is eyeing high-single-digit overall sales growth in 2026. But vaccines will remain a weak spot ‌in the United States where Health Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist, has upended official recommendations in the past year. ...
Drugmakers Roche and Sanofi talk up their pipelines, as earnings fail to excite
CNBC· 2026-01-29 11:31
Core Viewpoint - Roche and Sanofi's latest earnings met expectations, with both companies emphasizing the importance of developing new drugs to counteract the impending "patent cliff" facing the pharmaceutical industry [1][2]. Roche - Roche's sales grew by 8% in the fourth quarter, driven by blockbuster drugs like Ocrevus and Tecentriq [5]. - The company forecasts profit growth to outpace sales growth by 2026, with adjusted earnings per share expected to grow by high single digits at constant currencies [5]. - Roche plans to launch up to 19 new medicines by the end of the decade, focusing on late-stage development [3]. - The company is entering the obesity market with its weight-loss candidate CT-388, which showed a 22.5% weight reduction in Phase 2 trials, comparable to competitors [10]. - Roche has partnered with Zealand Pharma to co-develop the drug petrelintide, aiming to invest in next-generation obesity treatments [11]. Sanofi - Sanofi reported a 13% sales growth in the fourth quarter at constant currencies, with earnings per share of 1.53 euros ($1.20), exceeding forecasts [6]. - The company anticipates sales growth in the high single digits for 2026, with profit growth expected to be slightly higher than revenue [8]. - Sanofi's growth was supported by new medicines and its drug Dupixent, which reached a new quarterly high [8]. - The company announced a 1 billion euro share buyback, but investor focus remains on its research and development efforts [8]. - The need to expand the pipeline will be a key topic in Sanofi's earnings call, highlighting long-term R&D spending and potential M&A activities [9].