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投资约10亿欧元 赛诺菲将在京新建胰岛素生产基地
中国经济网· 2024-12-02 13:32
新华社北京12月2日电(记者郭宇靖)记者从北京经济技术开发区了解到,2日,北京市经济和信息化 局、北京经济技术开发区管委会与国际知名药企赛诺菲正式签署合作备忘录,赛诺菲将投资约10亿欧 元,在北京亦庄新建胰岛素生产基地。这将是赛诺菲在华第四个生产供应基地,并创造该公司在华最大 单笔投资纪录。 此次新设立的胰岛素生产基地将主要生产胰岛素生物制剂活性物质,为赛诺菲北京工厂现有胰岛素制剂 产品供给生物原料。赛诺菲首席执行官韩保罗表示,通过采用高标准的自动化生产方式、一流的数字化 综合管理和可持续的环保标准,新的生产基地将进一步帮助公司增强供应链韧性,更高效地满足不断增 长的糖尿病患者需求。 赛诺菲董事会主席弗雷德里克·乌代阿表示,赛诺菲坚定看好中国市场长期发展,中国秉持的对外开放 和鼓励创新的政策,以及为外资企业营造的良好营商环境,为赛诺菲深度参与中国经济发展、助力医药 产业高质量发展注入了强大信心。 北京经开区有关负责人表示,将持续优化营商环境,营造开放包容的产业生态,支持跨国药企选择北 京、投资亦庄,共绘医药健康产业发展新蓝图。 赛诺菲是一家总部位于法国的跨国制药企业,目前在国内拥有多家生产基地和研发基地。其中 ...
Pharma giant Sanofi opens $595 million vaccine facility in Singapore to boost preparedness for potential pandemics
CNBC· 2024-11-27 07:56
A Sanofi logo sits on the facade of the company's headquarters on December 11, 2020 in Gentilly near Paris, France.SINGAPORE — French pharmaceutical giant Sanofi on Wednesday opened a 800 million Singapore dollar ($595 million) "evolutive vaccine facility," or EVF, in Singapore — the only such facility the company has outside of France.This plant, known as Modulus, can switch between making different vaccines or treatments in a matter of days, compared to several weeks or months in more conventional facilit ...
FDA Accepts SNY and REGN's Dupixent Re-Submitted sBLA for Urticaria
ZACKS· 2024-11-18 21:01
Sanofi (SNY) and partner Regeneron (REGN) announced that the FDA has accepted their resubmitted supplemental biologics license application (sBLA) seeking approval of Dupixent for the treatment of chronic spontaneous urticaria (CSU).The sBLA seeks approval for CSU in people aged 12 years and older whose disease is not adequately controlled with existing therapies like H1 antihistamines. The FDA’s decision on the sBLA is expected on April 18, 2025.The FDA had issued a complete response letter (CRL) for the fi ...
Press Release: Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myeloma
GlobeNewswire News Room· 2024-11-14 16:42
Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myeloma Recommendation based on IMROZ phase 3 study demonstrating Sarclisa in combination with VRd significantly improved progression-free survival, compared to standard-of-care VRd aloneIf approved, Sarclisa would be the first anti-CD38 therapy in the EU available for use in combination with VRd for adult patients with transplant-ineligible NDMM Paris, November 14, 2024. The European Medicines Agency (E ...
Sanofi: Diverse Drug Portfolio And Future Pipeline, 4% Dividend Yield Looks Attractive
Seeking Alpha· 2024-11-13 10:42
This is the official page of Croatian-American media personality Albert Anthony. Since 2023 he has been a media contributor to global financial media portal Seeking Alpha, reaching +1MM investors worldwide & his content often averaging +25,000 views monthly. As an independent contributor, his content on the Seeking Alpha portal provides curated analysis of stocks trading on major US exchanges, and building a diversified dividend income portfolio, but also a forward- looking view of where he thinks a stock w ...
The Accumulus Platform Powers Sanofi's Submissions to Multiple Regulators Around the World
GlobeNewswire News Room· 2024-11-07 14:05
BURLINGAME, Calif., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Accumulus Synergy, Inc. ("Accumulus"), is revolutionizing the scalability of reliance pathways, enabling a recent submission from Sanofi to multiple national regulatory authorities (NRAs) around the globe. As industry leaders are set to leverage the Accumulus platform for upcoming projects, its ability to handle concurrent submissions across multiple jurisdictions is proving to be a game-changer. "The Accumulus platform introduces unprecedented scalabili ...
Sanofi Cancels Consumer Healthcare Business Spin-Off
Forbes· 2024-10-30 18:28
Photographer: Nathan Laine/Bloomberg© 2024 Bloomberg Finance LPDeal Overview On October 21, 2024, Sanofi (NASDAQ: SNY US (ADR), $53.83, Market Cap: $136.6 billion, EN Paris: SAN FP, €100.04, Market Cap: €126.9 billion) announced that it has entered into exclusive negotiations with the US private equity firm Clayton, Dubilier & Rice (CD&R) to transfer around 50% controlling stake in Opella. Opella is Sanofi’s consumer healthcare business unit focusing on over-the-counter medicines, vitamins, minerals, and s ...
Why Sanofi Stock Flew Higher on Friday
The Motley Fool· 2024-10-25 21:23
No investor can ignore a crushing bottom-line beat and raised profitability guidance. Investors traded on the latest news about global pharmaceutical company Sanofi (SNY 4.40%) Friday. Happily for existing shareholders, the news -- of its third-quarter results -- was encouraging, and the stock rose as the trading week came to a close. It climbed more than 4%, sharply contrasting the basically flat-lining S&P 500 index. Crushed bottom-line consensus One reason investors were impressed by Sanofi's latest fund ...
Sanofi(SNY) - 2024 Q3 - Earnings Call Transcript
2024-10-25 17:36
Financial Data and Key Metrics - Q3 2024 total sales reached EUR13.4 billion, a 16% increase at constant exchange rates (CER), with an estimated 11% growth excluding phasing impacts [3] - Dupixent sales approached EUR3.5 billion in Q3, driven by global volume growth across all indications and geographies [3] - Vaccines business grew 26%, benefiting from flu season phasing and strong contributions from Beyfortus [3] - Pharma launches saw a 67% increase in sales, driven by strong performance across eight recently launched medicines [4] - Business operating income increased by 19.9% in Q3, driven by higher gross profit and operating leverage [13] - Business EPS increased by 17.6% in Q3, with full-year 2024 guidance upgraded to at least low-single-digit growth [13][15] Business Line Performance - Dupixent achieved a milestone of improving the lives of over 1 million patients globally, with strong market share in the US and approaching blockbuster status outside the US [4][5] - Beyfortus sales reached EUR645 million in Q3, with exceptional market uptake in its second season [8] - ALTUVIIIO sales were EUR172 million, establishing it as a new standard of care in hemophilia A [8] - Nexviazyme, Rezurock, and Sarclisa contributed EUR1.4 billion in sales in Q3 [8] - Opella grew 8%, driven by the strategic acquisition of Qunol in the US [4] Market Performance - Dupixent's COPD indication was approved in the US and China, following EU approval four months prior, expanding its market potential [5] - Beyfortus demonstrated 87% efficacy in reducing RSV hospitalization rates in the US, with real-world evidence supporting its effectiveness [9] - Fluzone High-Dose showed 24% superior efficacy compared to standard-dose flu vaccines in a randomized controlled trial [10] - Beyfortus is expected to reach EUR1.5 billion in sales for 2024, with additional capacity supporting Q4 sales [13] Strategic Direction and Industry Competition - The company is focusing on geographic expansion, with around 30 potential country launches for Dupixent by 2026 [6] - Dupixent's growth is supported by penetration into new indications like COPD and chronic spontaneous urticaria (CSU) [6] - The company is advancing its ESG commitments, including ensuring a living wage for employees and improving supply chain partner well-being [10][11] - Sanofi is transitioning to a pure-play biopharma company, with plans to sell a controlling stake in Opella to CD&R for EUR16 billion EV [15] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in Dupixent's growth, targeting a low-double-digit sales CAGR between 2023 and 2030 [7] - The company expects strong growth in 2025, with business EPS increasing over 2024, even without Opella [33] - R&D expenses are aligned with the company's commitment to innovation, with EUR700 million in increased R&D costs for 2024 [14] - The company is focused on bolt-on acquisitions and maintaining a strong credit rating, avoiding large acquisitions [17] Other Important Information - The company is investing in external innovation, including partnerships with MeiraGTx, Ventyx, AnaptysBio, and Vicore [19] - Sanofi completed a licensing agreement with RadioMedix and Orano Med for AlphaMedix, a radioligand for rare cancers [20] - The company is advancing its pipeline with six Phase 3 readouts, 11 submissions, and 10 regulatory decisions planned over the next 18 months [24] Q&A Session Summary Question: Beyfortus Commercial Potential and Opella Deal Proceeds [25] - Management highlighted Beyfortus' strong market position and potential for growth, with confidence in its efficacy and safety data [26] - The Opella deal is expected to generate high-single-digit billion euros in proceeds, with debt pass-through and tax considerations [28] Question: Dupixent COPD Launch Metrics and Opella Proceeds [30] - Early feedback on Dupixent's COPD launch has been positive, with expectations for significant market penetration [31] - The company clarified that the dilution from Opella's sale will be absorbed, with business EPS expected to increase in 2025 [33] Question: Beyfortus Market Penetration and Buyback Authority [34] - Beyfortus is launched in close to 20 countries, with plans for further expansion in 2025 [35] - The company is actively discussing buybacks with the Board and will communicate capital allocation decisions when ready [36] Question: Amlitelimab Strategy and Growth Recovery [37] - Amlitelimab's OX40 ligand pathway is seen as a key differentiator, with potential for significant impact in asthma and other inflammatory diseases [39] - The company expects strong growth recovery in 2025, with accelerated business EPS growth in 2024 [40] Question: Opella Financial Reporting and Tax Rate [43] - Opella's financials will be reported as a discontinued operation in 2024, with an expected underlying tax rate of around 20% [44] Question: IRA Impact and Dupixent Payer Negotiations [45] - The Inflation Reduction Act (IRA) is seen as a mixed impact, with some provisions benefiting patients but potentially limiting innovation [45] - Dupixent's payer negotiations are supported by strong demand growth and a clear strategy for expanding access [45] Question: Stranded Costs and Vaccine Phase 3 Trials [47] - Stranded costs from Opella are not expected to be material, with sales and marketing investments continuing into 2025 [48] - The company is on track to start Phase 3 trials for its 21-valent pneumococcal vaccine in 2024 [50] Question: Radioligand Strategy and Supply Chain [54] - Sanofi is excited about the radioligand space, particularly Lead-212, which has shown promise in rare cancers [56] - The company is confident in its supply chain capabilities, working with Orano Med to ensure timely delivery [57] Question: Beyfortus Capacity and BPI Influence [60] - Beyfortus capacity has been tripled in 2024, with no anticipated supply constraints in 2025 and 2026 [62] - BPI France's influence on Opella is limited, with a 1-2% stake and minimal governance impact [63] Question: Beyfortus Durability and Pneumococcal Vaccine [65] - Beyfortus has demonstrated 83% efficacy against RSV hospitalization after six months, with no waning efficacy [65] - The company is on track to start Phase 3 trials for its 21-valent pneumococcal vaccine in 2024 [68] Question: OX40 Ligand and Pipeline Readouts [70] - Sanofi remains confident in the OX40 ligand pathway, with differentiation from competitors like Amgen [72] - The company plans to disclose pipeline readouts at scientific congresses, with material results communicated promptly [73] Question: Beyfortus Growth and RSV Market Potential [74] - Beyfortus is expected to grow in 2025, regardless of competition, with a focus on all-infant protection [75] - The RSV market potential remains strong, with additional opportunities in pediatric RSV vaccines [75] Question: Beyfortus Dosing and Opella Proceeds [78] - Beyfortus' dosing strategy is tailored to different channels, with no significant disadvantage compared to competitors [80] - Opella proceeds are expected to be high-single-digit billion euros, net of taxes and transaction costs [81] Question: Dupixent LOE and Anti-TL1A Update [82] - Dupixent's LOE is expected in 2031 in the US and 2033 in Europe, with additional patents extending protection [82] - Anti-TL1A data is expected in H2 2024, with updates from Teva and Sanofi [84] Question: Hidradenitis Suppurativa Strategy and Beyfortus Capacity [87] - Sanofi is pursuing a franchise strategy in Hidradenitis Suppurativa, with multiple mechanisms of action under development [89] - Beyfortus capacity has been tripled, with no supply constraints anticipated for 2025 [92] Closing Remarks [93] - Sanofi reaffirmed its strong business momentum, with continued execution on launches and pipeline advancements, aiming to become a pure-play biopharma leader [93]
Sanofi Q3 Earnings Beat, Dupixent, New Drugs, Vaccines Drive Sales
ZACKS· 2024-10-25 17:20
Sanofi (SNY) reported third-quarter 2024 adjusted earnings of $1.57 per American depositary share, which beat the Zacks Consensus Estimate of $1.35 per share. Earnings of €2.86 per share rose 12.2% on a reported basis and 17.6% on a constant currency rate (“CER”) basis.Net sales rose 12.3% on a reported basis to $14.77 billion (€13.44 billion). Exchange rate movements hurt sales by 3.4% in the quarter. Sales rose 15.7% on a CER basis. Sales beat the Zacks Consensus Estimate of $14.39 billion.Sales rose 23.6 ...