Core Viewpoint - Sarclisa has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for approval in combination with VRd for treating transplant-ineligible newly diagnosed multiple myeloma (NDMM) patients, potentially establishing a new standard of care in the EU [1][2][4] Group 1: Approval and Clinical Study - The CHMP's recommendation is based on the IMROZ phase 3 study, which demonstrated that Sarclisa combined with VRd significantly improved progression-free survival (PFS) compared to VRd alone [1][4] - If approved, Sarclisa would be the first anti-CD38 therapy available in the EU for this patient population [1] - The IMROZ study is the first global phase 3 study of a CD38 monoclonal antibody in combination with standard-of-care VRd [4] Group 2: Current Approvals and Indications - Sarclisa is currently approved in over 50 countries, including the US and EU, for treating certain adult patients with relapsed or refractory multiple myeloma (MM) [3][6] - In the US, Sarclisa is also approved in combination with VRd as a first-line treatment for adult patients with NDMM who are not eligible for autologous stem cell transplant [6] Group 3: Company Strategy and Future Directions - Sanofi is advancing Sarclisa as part of a patient-centric clinical development program, which includes several phase 2 and phase 3 studies across the multiple myeloma treatment continuum [7] - The company is also exploring a subcutaneous administration method for Sarclisa in clinical studies [7] - Sanofi aims to become the leading immunoscience company globally, focusing on difficult-to-treat cancers, including multiple myeloma [8]

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 ...

从全球投资者到产业赋能者。 本文为IPO早知道原创 作者｜Stone Jin 微信公众号｜ipozaozhidao 据IPO早知道消息，在第七届进博会期间，凯辉基金与全球制药巨头赛诺菲（Sanofi）签订合作备忘 录深化医疗领域的创新合作。这一合作项目不仅是双方长期合作关系的进一步深化，更是对推动中法 合作以及中国医药产业转型与升级的积极响应。 此次合作在为中国创新医药提供创新生态圈的支持之外，更结合了赛诺菲在全球制药行业的技术积累 与凯辉基金的行业洞察和跨境投资经验，从研发、临床实验到市场推广、监管合规等多个维度提供全 方位的解决方案，帮助中国医药创新生态发展，实现技术突破和商业化成功，从而释放中国创新的全 球化潜力。 目前，凯辉基金已在全球范围内投资超47家医疗健康相关企业，积极促进全球医疗合作与发展。凯 辉基金创始人及董事长蔡明泼表示："此次合作备忘录的签订不仅是双方在战略上的深度共鸣，更是 共同致力于推动中国医疗健康事业的重要里程碑。 我们期待通过这一合作实现全球领先医药企业与 本土创新力量的双向赋能，并推动更多优秀的中国创新药企实现可持续发展，为患者带来更好的治疗 选择，同时为社会创造更大的价值。" ...

Deal Overview - On October 21, 2024, Sanofi announced exclusive negotiations with Clayton, Dubilier & Rice (CD&R) to transfer around 50% controlling stake in Opella, its consumer healthcare business unit focusing on over-the-counter medicines, vitamins, and supplements [1][2] - The deal values Opella at approximately €16 billion, implying 14 times the 2024 estimated EBITDA [2] Strategic Rationale - Sanofi aims to create a standalone leader in consumer healthcare while focusing on innovative medicines and vaccines [2] - The divestment aligns with Sanofi's 'Play to Win' strategy initiated in December 2019, which emphasizes enhancing growth and fostering innovation [5] - The company expects to achieve around €2.0 billion in cost savings from 2024 until the end of 2025, which will be reallocated to fund innovation [7] Company Performance - The Biopharma business contributed approximately 87.8% of FY23 total revenue, while Consumer Healthcare contributed about 12.2% [6] - Opella generated $5.6 billion in revenue during FY23 and operates in 100 countries with 13 manufacturing facilities [10] Market Position and Future Outlook - By retaining a significant stake in Opella, Sanofi can benefit from the consumer healthcare market while reallocating resources to high-growth areas like specialty care and vaccines [8] - The partnership with CD&R is expected to enhance Opella's operational efficiency and market competitiveness [8]

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 ...

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 (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 ...

On Friday, Sanofi SA SNY reported a third-quarter business operating income of 4.61 billion euros ($4.99 billion), up 14.4% year-over-year and 19.9% in constant currency.The company reported third-quarter sales of 13.44 billion euros or $14.79 billion, beating the consensus of $13.97 billion.Sales increased 12.3% year over year and 15.7% on constant currency, led by solid growth from Dupixent, Pharma launches, vaccines, and Opella.The French drugmaker reported adjusted EPS of 2.86 euros or $1.57, up 12.2% ( ...

Core Insights - Sanofi reported a Q3 sales growth of 15.7% at constant exchange rates (CER), with business EPS of €2.86, reflecting strong performance across its portfolio [1][3] - The company confirmed a full-year 2024 sales target of approximately €13 billion for Dupixent, which saw a 23.8% increase in sales to €3,476 million [1][3] - Sanofi upgraded its 2024 business EPS guidance to a growth of at least a low single-digit percentage at CER, excluding Opella [2][3] Financial Performance - Q3 IFRS net sales were reported at €13,438 million, a 12.3% increase, with a 15.7% change at CER [4] - Business operating income for Q3 was €4,607 million, up 14.4%, while business net income reached €3,585 million, reflecting a 12.2% increase [5] - Free cash flow for Q3 was €3,327 million, showing a significant increase of 79.5% [5] Product and Pipeline Developments - Sales from new pharmaceutical launches increased by 67.1% to €727 million, driven by products like ALTUVIIIO, Nexviazyme, and Rezurock [1] - Vaccine sales rose by 25.5%, supported by the timing of flu sales and increased capacity for Beyfortus [1] - Sanofi achieved four regulatory approvals and four positive phase 3 data readouts in Q3, including for Dupixent in COPD and other indications [1][3] Strategic Moves - Sanofi entered exclusive negotiations with CD&R to transfer a controlling stake in Opella, allowing the company to focus on innovative medicines and vaccines [1][3]

Sanofi (SNY) has entered into exclusive negotiations with U.S.-based private equity company Clayton Dubilier & Rice (CD&R) for the potential sale of a 50% controlling stake in its consumer healthcare (CHC) business unit, Opella.Per the terms of the deal, Sanofi will remain a significant shareholder of Opella. In addition, the French investment bank, Bpifrance, is likely to hold a 2% stake and become a minority shareholder in Opella.The transaction is expected to close at the earliest in the second quarter o ...