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独家|赛诺菲确认阿利西尤单抗注射液停供 在华心血管产品策略将升级
news flash· 2025-08-04 05:06
Core Viewpoint - Sanofi has confirmed the cessation of the supply of its drug, Praluent (alirocumab injection), in the Chinese market due to global supply issues and a strategic upgrade in its cardiovascular product offerings in China [1] Group 1: Supply and Strategic Changes - The decision to stop supplying Praluent is attributed to global supply challenges [1] - Sanofi is upgrading its cardiovascular product strategy in China, which includes a partnership with Jinxing Pharmaceutical for Aficamten and acquiring rights for the investigational drug, Plerixafor [1] - The company emphasizes its commitment to continue providing a range of products to meet the needs of domestic patients [1]
Regeneron Reports Second Quarter 2025 Financial and Operating Results
Globenewswire· 2025-08-01 10:30
Core Insights - Regeneron Pharmaceuticals reported strong financial results for Q2 2025, with notable growth in U.S. sales of EYLEA HD and global sales of Dupixent and Libtayo, alongside multiple regulatory approvals [2][3][5] Financial Highlights - Total revenues for Q2 2025 reached $3.68 billion, a 4% increase from $3.55 billion in Q2 2024 [3][12] - GAAP net income was $1.39 billion, down 3% from $1.43 billion in the same quarter last year, while non-GAAP net income increased by 5% to $1.42 billion [3][12] - Non-GAAP net income per share rose 12% to $12.89, compared to $11.56 in Q2 2024 [3][12] Business Highlights - Dupixent global net sales increased by 22% to $4.34 billion, while EYLEA HD U.S. net sales grew by 29% to $393 million [5][12] - The FDA approved Lynozyfic for relapsed or refractory multiple myeloma and Dupixent for bullous pemphigoid and chronic spontaneous urticaria [5][10] - The company has approximately 45 product candidates in clinical development, with significant progress in its oncology portfolio [4][5] Regulatory and Pipeline Updates - The FDA accepted for priority review Libtayo's supplemental Biologics License Application for adjuvant cutaneous squamous cell carcinoma, with a target action date in October 2025 [10][11] - The company reported interim results from the Phase 2 COURAGE trial, showing promising data for obesity treatment [10][11] Capital Allocation - Regeneron returned over $2.3 billion to shareholders through share repurchases and dividends, while committing over $7 billion to U.S. manufacturing investments and business development since the start of 2025 [3][23] - A cash dividend of $0.88 per share was declared, payable on September 3, 2025 [24]
Press release: Online availability of Sanofi's half-year financial report for 2025
GlobeNewswire News Room· 2025-07-31 16:20
Company Overview - Sanofi is an R&D driven, AI-powered biopharma company focused on improving people's lives and delivering growth [3] - The company utilizes its deep understanding of the immune system to develop medicines and vaccines that benefit millions globally [3] - Sanofi is committed to addressing urgent healthcare, environmental, and societal challenges [3] Financial Reporting - Sanofi's half-year financial report for the period ending June 30, 2025, is now available [1] - The report has been filed with the French market regulator Autorité des marchés financiers (AMF) and submitted to the U.S. Securities and Exchange Commission (SEC) under form 6-K [1] Accessibility - The financial report can be found on Sanofi's corporate website and downloaded from the "Investors" page under "Regulated Information" [2]
Sanofi Q2 Earnings & Sales Miss, 2025 Top-Line View Raised, Stock Down
ZACKS· 2025-07-31 15:41
Key Takeaways Sanofi (SNY) reported second-quarter 2025 adjusted earnings of 90 cents per American depositary share, which missed the Zacks Consensus Estimate of 96 cents per share. Earnings of €1.59 per share rose 1.9% on a reported basis and 8.3% on a constant currency rate ("CER") basis. Net sales rose 6% on a reported basis to $11.33 billion (€10.0 billion). Sales rose 10.1% on a CER basis. Sales missed the Zacks Consensus Estimate of $11.53 billion. Sales rose 17.3% at CER in the United States, 4.4% in ...
Sanofi(SNY) - 2025 Q2 - Quarterly Report
2025-07-31 15:33
Exhibit 99.1 Exhibit 99.1 TABLE OF CONTENTS | 1. Condensed half-year consolidated financial statements | 2 | | --- | --- | | Consolidated balance sheets - assets | 2 | | Consolidated balance sheets - equity and liabilities | 3 | | Consolidated income statements | 4 | | Consolidated statements of comprehensive income | 5 | | Consolidated statements of changes in equity | 6 | | Consolidated statement of cash flows | 8 | | Notes to the condensed half-year consolidated financial statements as of June 30, 2025 | ...
Sanofi(SNY) - 2025 Q2 - Earnings Call Transcript
2025-07-31 13:32
Financial Data and Key Metrics Changes - Net sales increased by 10.1% at constant exchange rates in Q2, primarily driven by immunology, biopharma launches, and Befortus [16][26] - Business EPS was €1.59, up 8.3%, reflecting strong sales performance and improved gross margin [18][26] - Gross margin improved by 1.5 percentage points, largely due to an improved product mix and efficiencies [16][18] Business Line Data and Key Metrics Changes - New launches generated close to €1,000,000,000 in sales, representing 10% of total sales [7][10] - Dupixent sales reached €3,800,000,000, up 21% in Q2, driven by strong demand across geographies [10][11] - Vaccine business sales increased by 10.3%, benefiting from the late flu season in the Northern Hemisphere [11][12] Market Data and Key Metrics Changes - Dupixent sales in the U.S. reached €2,800,000,000, up 22.7%, leading in new to brand prescriptions [10] - Outside the U.S., sales exceeded $1,000,000,000, driven by volume growth in key markets [10] - Anticipated sales split for flu vaccines is about 75% in Q3 and 25% in Q4, with total sales expected to decrease by a mid-teens percentage due to competitive pressures [25][26] Company Strategy and Development Direction - The company refined its 2025 sales guidance to high single-digit percentage growth at constant exchange rates, reflecting confidence in growth drivers [6][26] - The completion of the Blueprint Medicines acquisition strengthens the company's position in rare immunology diseases [13][14] - The company is committed to sustainability, aiming for all new medicines and vaccines to incorporate eco-design principles by 2025 [15][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the full-year business outlook, supported by strong performance from growth drivers [6][26] - The company is navigating uncertainties from potential U.S. tariffs and EU exports, with updates to be provided as more information becomes available [27][28] - Management remains optimistic about the pipeline and the potential for new product launches to drive future growth [41][45] Other Important Information - R&D expenses increased by 17.7% due to a lower base of comparison last year, with underlying R&D expenses up around 7% [17][18] - The company is executing a €5,000,000,000 share buyback program in 2025, with over 80% already completed [21][22] Q&A Session Summary Question: R&D transformation and pipeline progress - Management acknowledged the progress in R&D but noted that the share price is lagging, awaiting further pipeline developments [41][42] - Confidence remains in the Phase III trials and the potential for achieving €10 billion in sales by 2030 [42][43] Question: Development spend and margin outlook - R&D expenses are expected to be slightly up in H2, with SG&A increasing at half the rate of sales growth [50][52] - Management anticipates BOI margin growth alongside absolute growth in the coming years [54][56] Question: Dupixent performance in China - Dupixent has seen over 30% volume growth in China, despite pricing pressures [58][59] Question: Expectations for amlitilumab and tariffs - The company has not factored potential tariff impacts into its 2025 guidance, expecting limited effects due to existing inventory [63][64] - Amlitilumab is expected to provide comparable efficacy to existing treatments with a longer dosing interval [66][67]
Sanofi(SNY) - 2025 Q2 - Earnings Call Transcript
2025-07-31 13:30
Financial Data and Key Metrics Changes - Net sales increased by 10.1% at constant exchange rates in Q2 2025, primarily driven by immunology, biopharma launches, and Befortus [15][25] - Business EPS was €1.59, up 8.3%, reflecting strong sales performance and improved gross margin [15][25] - Gross margin improved by 1.5 percentage points due to an improved product mix and efficiencies [15] Business Line Data and Key Metrics Changes - New launches generated close to €1,000,000,000 in sales, representing 10% of total sales [6][7] - Dupixent sales reached €3,800,000,000, up 21% in Q2, driven by strong demand across geographies [7][8] - Vaccine business sales increased by 10.3%, benefiting from the late flu season in the Northern Hemisphere [9][10] Market Data and Key Metrics Changes - Dupixent sales in the U.S. reached €2,800,000,000, up 22.7%, leading in both new to brand prescriptions and total prescriptions [8] - Outside the U.S., sales exceeded $1,000,000,000, driven by volume growth in key markets [8] - Anticipated sales split for flu vaccines is about 75% in Q3 and 25% in Q4, with total sales expected to decrease by a mid-teens percentage due to competitive pressures [24][25] Company Strategy and Development Direction - The company refined its 2025 sales guidance to high single-digit percentage growth at constant exchange rates, reflecting confidence in growth drivers [5][25] - The completion of the Blueprint Medicines acquisition strengthens the company's position in rare immunology diseases and enhances its pipeline [12][18] - The company is committed to sustainability, aiming for all new medicines and vaccines to incorporate eco-design principles by 2025 [13][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the full-year business outlook, supported by strong performance from growth drivers [5][25] - The company is navigating uncertainties from potential U.S. tariffs and EU exports, with updates to be provided as more information becomes available [26] - Management highlighted the importance of maintaining a strong market share despite competitive pricing pressures in the flu vaccine market [24][25] Other Important Information - The company is executing a €5,000,000,000 share buyback program in 2025, with over 80% already completed [20] - The anticipated negative year-on-year BOI impact from Regeneron reimbursement is approximately €300,000,000 in 2026 and €800,000,000 in 2027 [22] Q&A Session Summary Question: R&D transformation and pipeline progress - Management acknowledged the progress in R&D but noted that the share price is lagging, indicating a need for pipeline advancements [42][43] - Confidence remains in achieving the targeted increase in Phase III trials and the potential for significant sales by 2030 [43][46] Question: Development spend and pricing pressures - R&D expenses are expected to be slightly up in H2, with SG&A increasing at half the rate of sales growth [51][55] - Management confirmed that pricing pressures in the flu market are being addressed, with expectations for continued market share despite competitive dynamics [72][75] Question: Dupixent growth in China - Dupixent has seen over 30% volume growth in China, with management optimistic about future growth despite pricing pressures [60][62] Question: Expectations for amlitelemab and tariffs - Management emphasized the importance of efficacy and treatment duration for amlitelemab in the atopic dermatitis market [68][69] - No significant impact from tariffs is expected for 2025 due to existing inventory [66][67]
赛诺菲上半年营收高达226亿美元,度普利尤单抗大卖 83 亿美元
Guo Ji Jin Rong Bao· 2025-07-31 13:19
7 月 31 日,赛诺菲官方微信发布二季报财报。数据显示,第二季度,公司实现营收额为100亿欧元 (约 114亿美元),增长 10.1%;今年上半年,公司实现总营收额为 198.89 亿欧元(约 226 亿美元), 增长 9.9%。(汇率1 欧元=1.14 美元)。研发投入为37.17欧元(约42亿美元),占总营收的18.7%。 从区域收益看,今年上半年:赛诺菲在美国市场的收入最多,为 95.35 亿欧元(约108.8亿美元), 增长 16.4%;欧洲市场销售额为 41.44 亿欧元(约47.2亿美元),增长 1.8%;中国市场收入为 13.88 亿 欧元(约合15.8亿美元),增长 0.1%。 此前,赛诺菲此前押注了罕见病领域,产品布局方面,公司推出Altuviiio(A 型血友病药物)、晚 发性庞贝病替代疗法Nexviazyme(艾夫糖苷酶α)、治疗酸性鞘磷脂酶缺乏症的Xenpozyme等12款产品 矩阵。其中,血友病药物Altuviiio在上市两年内迅速渗透市场,今年上半年销售额已经达到5.42亿欧 元。在血友病领域,赛诺菲的另一款重要产品,成为该领域首款RNAi疗法,上市三个月收入100万美 元。 赛 ...
Sanofi(SNY) - 2025 Q2 - Earnings Call Presentation
2025-07-31 13:00
Financial Performance - Sanofi reported Q2 2025 net sales of €10 billion, a 10.1% increase at CER [16] - Gross profit increased by 12.4% to €7.742 billion, with a gross margin of 77.5% [59] - Business EPS grew by 8.3% to €1.59, reflecting operating income growth and lower share count from buyback [59, 61] - The company refines 2025 sales guidance to high single-digit percentage growth [15, 19] Key Products & Pipeline - Dupixent sales reached €3.832 billion in Q2 2025, a 21.1% increase [16, 119] - Vaccines sales grew by 10.3%, driven by Beyfortus [16] - Pharma launches contributed €969 million to sales [21] - Ayvakit sales increased by 52.5% [43] Strategic Initiatives - Sanofi is actively redeploying capital through organic investment, BD/M&A, growing dividend, and share buyback [62] - The company completed the acquisition of Blueprint Medicines on July 17, 2025 [46, 64] - Sanofi is reducing environmental impact across the portfolio, with reductions in carbon footprint, water use, and resource depletion [50]
美股异动|赛诺菲盘前跌超4% Q2研发开支增加导致经营溢利逊于预期
Ge Long Hui· 2025-07-31 09:12
Group 1 - Sanofi's stock dropped over 4% in pre-market trading, reaching $47.23, following the release of its Q2 earnings report [1] - The company reported Q2 sales of €9.994 billion, meeting expectations with a year-on-year growth of 6%, and a 10.1% increase at constant exchange rates [1] - Excluding one-time items, the operating profit for the quarter was €2.461 billion, which fell short of the expected €2.57 billion due to rising R&D costs and higher profit-sharing with partner Regeneron Pharmaceuticals [1] Group 2 - Driven by strong demand for its flagship anti-inflammatory drug Dupixent, vaccines, and new therapies, Sanofi raised its full-year sales guidance, now expecting high single-digit growth instead of mid to high single-digit growth at constant exchange rates [1] - The company confirmed its forecast for a low double-digit growth in net profit for the year, which includes all expenses related to newly acquired businesses [1]