Core Insights - Sanofi SA reported third-quarter sales of $14.55 billion, exceeding the consensus estimate of $14.46 billion, with a year-over-year increase of 2.3% and a 7% rise in constant currency [1] Financial Performance - The company achieved a business operating income of 4.45 billion euros, reflecting an 8.5% year-over-year increase and a 2.7% rise in constant currency [2] - Adjusted EPS was reported at 2.91 euros or $1.70 per ADS, surpassing the consensus of 1.60 cents, marking a 7% increase (+13.2% in constant currency) [2] Sales Breakdown - Dupixent sales reached 4.16 billion euros, up 26.2%, with global sales exceeding 4 billion euros for the first time, driven by strong demand across all approved indications [3] - Vaccine sales totaled 3.36 billion euros, down 7.8%, primarily due to lower influenza vaccine sales [3] - Beyfortus sales were 739 million euros, up 19.8%, with significant growth in Europe (+166.3%) and the Rest of World (+526.7%) due to the geographical roll-out of infant protection [3] Future Guidance - Sanofi reaffirms its 2025 sales growth guidance of high single digits at constant exchange rates (CER) [3] - The company expects a strong business EPS rebound, projecting growth in the low double digits at CER [4] Regulatory Update - The FDA has extended the review date for Sanofi's new drug application for tolebrutinib, with a revised target action date set for December 28, 2025 [4] Stock Performance - Sanofi's stock was up 1.98% at $50.50 during the premarket session [5]

Group 1 - The company has made significant advancements in its pipeline, although there were mixed results from the itepekimab readout, which has created a complicated situation [2] - The company is optimistic about the feedback received for amlitelimab and is excited about developments in the immunology marketplace [2] - The extension of the PDUFA for tolebrutinib is seen positively, as the company prefers a thorough review of data over a rushed decision [3] Group 2 - The underlying performance of the company is reported to be strong [4]

Core Insights - Sanofi's new drug application (NDA) for tolebrutinib has had its target action date extended by three months to December 28, 2025, due to the submission of additional analyses deemed a major amendment by the FDA [1][5] - Tolebrutinib is an investigational oral Bruton's tyrosine kinase (BTK) inhibitor aimed at treating non-relapsing, secondary progressive multiple sclerosis (nrSPMS) [1][6] - The NDA is supported by data from three late-stage studies, showing that tolebrutinib delayed disability progression compared to placebo and Aubagio [2][5] Company Overview - Tolebrutinib is the first and only brain-penetrant BTK inhibitor targeting both nrSPMS and relapsing MS (RMS) [6][8] - Currently, there are no approved therapies for nrSPMS, highlighting a significant unmet medical need [6][7] - Sanofi acquired tolebrutinib through its purchase of Principia in 2020, and it holds Breakthrough Therapy designation from the FDA for the nrSPMS indication [8] Clinical Development - The FDA accepted the NDA for tolebrutinib under its priority review pathway in March 2025 [2][5] - A phase III study (PERSEUS) is ongoing to evaluate tolebrutinib in primary progressive MS, with data expected by the end of 2025 [8] - In 2022, the FDA placed a partial clinical hold on phase III studies due to drug-induced liver injury cases, leading to the discontinuation of studies in myasthenia gravis [9] Market Performance - Year-to-date, Sanofi's shares have decreased by 2.5%, while the industry has seen a growth of 0.9% [3]

Update on the US regulatory review of tolebrutinib in non-relapsing, secondary progressive multiple sclerosis Paris, September 22, 2025. The US Food and Drug Administration (FDA) has extended by three months the target action date of its review of the new drug application (NDA) of tolebrutinib, an oral and brain-penetrant investigational Bruton's tyrosine kinase (BTK) inhibitor to treat non-relapsing, secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relaps ...

Core Insights - Sanofi reported a strong financial performance in Q2, with revenues reaching €10 billion (approximately $11.4 billion), marking a 10.1% increase year-over-year [1] - For the first half of the year, total revenues amounted to €19.889 billion (approximately $22.6 billion), reflecting a growth of 9.9% [1] - The company invested €3.717 billion (approximately $4.2 billion) in R&D, which constitutes 18.7% of total revenues [1] Revenue Breakdown - In the U.S. market, Sanofi generated the highest revenue of €9.535 billion (approximately $10.88 billion), a growth of 16.4% [3] - European sales reached €4.144 billion (approximately $4.72 billion), growing by 1.8% [3] - Revenue from the Chinese market was €1.388 billion (approximately $1.58 billion), with a minimal growth of 0.1% [3] Strategic Transformation - Since 2020, Sanofi has undergone significant restructuring to shift from a diabetes-focused company to a leader in immunology, reallocating resources towards immunology and inflammation [3] - The sales of Dupixent, a key product in the immunology sector, reached €7.312 billion (approximately $8.3 billion) in the first half of the year, with a year-over-year growth of 20.7% [3] Product Performance - Sales for the COPD treatment, Dupixent, reached €3.8 billion, while newly launched products generated €900 million in sales [3] - Vaccine sales totaled €1.214 billion in Q2, reflecting a growth of 10.3%, and €2.54 billion for the first half, with a growth of 10.9% [5] - The primary contributors to vaccine revenue included the PPH vaccine, which generated €1.361 billion, accounting for over half of the vaccine income [5] Investment in Rare Diseases - Sanofi has focused on the rare disease sector, launching 12 products including Altuviiio for hemophilia A, which achieved sales of €542 million in the first half of the year [4] - Another significant product in the hemophilia sector is an RNAi therapy that generated $1 million in revenue within three months of its launch [4] Future Prospects - Sanofi is increasing investments in the vaccine sector, having agreed to acquire Vicebio for up to $1.6 billion to enhance its vaccine development capabilities [5] - The company has 82 projects in its R&D pipeline across four major disease areas, with potential milestones expected in the second half of 2025 [6]

Investment Ratings - Bristol-Myers Squibb (BMY): Neutral [6] - Eli Lilly (LLY): Buy [10] - Novartis (NOVN): Neutral [16] - Sanofi (SNY): Neutral [17] - Biogen (BIIB): Buy [20] - Insmed Therapeutics (INSM): Buy [25] - Jazz Pharmaceuticals (JAZZ): Buy [29] - MoonLake Immunotherapeutics (MLTX): Buy [36] Core Insights - The report emphasizes the importance of idiosyncratic catalysts in the biopharma sector, particularly in the context of macroeconomic volatility and healthcare policy uncertainty [1] - Key catalysts to watch in 3Q25 include pivotal studies from various companies, with a focus on Alzheimer's disease, obesity, Sjogren's syndrome, multiple sclerosis, and gastroesophageal adenocarcinoma [1][5] - The report highlights the potential for significant market opportunities based on upcoming trial results and regulatory approvals, particularly for drugs like Cobenfy, orforglipron, ianalumab, tolebrutinib, and zanidatamab [1][5][10][18][30] Summary by Company Bristol-Myers Squibb (BMY) - Monitoring Phase 3 data from the Cobenfy ADEPT-2 trial in Alzheimer's disease psychosis, with a primary completion date in July [8] - The trial's success could have implications for a large patient population, with approximately 6 million Alzheimer's patients in the U.S. [8][9] Eli Lilly (LLY) - Focus on the ATTAIN-1 trial for orforglipron in obesity without diabetes, with results expected in July [10] - Anticipated weight loss efficacy in the 12-15% range, with safety and tolerability being key metrics [13] Novartis (NOVN) - Key focus on ianalumab's readouts in Sjogren's syndrome and immune thrombocytopenia, with a potential peak sales opportunity of approximately $2 billion [18] Sanofi (SNY) - Expected data from the Phase 3 PERSEUS trial of tolebrutinib in primary progressive multiple sclerosis, with a primary completion date in July [19] Biogen (BIIB) - Monitoring Leqembi's commercial trajectory in early-onset Alzheimer's disease, with a potential peak sales of approximately $800 million [21] Insmed Therapeutics (INSM) - Regulatory review of brensocatib for bronchiectasis, with a PDUFA date of August 12 [25] - Potential for significant upside if approved with a broad label [27] Jazz Pharmaceuticals (JAZZ) - Anticipating topline data from the HERIZON-GEA-01 trial for zanidatamab in gastroesophageal adenocarcinoma, with a potential peak sales opportunity exceeding $2 billion [30] MoonLake Immunotherapeutics (MLTX) - Reporting topline results from the Ph. 3 VELA trials for sonelokimab in hidradenitis suppurativa, with expectations for best-in-class efficacy [36]

Core Viewpoint - Sanofi's investigational BTK inhibitor tolebrutinib has received priority review from the FDA for treating non-relapsing secondary progressive multiple sclerosis (nrSPMS), with a final decision expected by September 28, 2025 [1][2]. Group 1: Regulatory Filing and Studies - The FDA's acceptance of the filing is based on data from three late-stage studies, including one focused on nrSPMS and two on relapsing MS (RMS), demonstrating that tolebrutinib delayed disability progression compared to placebo [2]. - A similar regulatory filing is under review by the EMA, also supported by the same studies [2]. Group 2: Unique Treatment Potential - Tolebrutinib is positioned as the first and only brain-penetrant BTK inhibitor for both nrSPMS and RMS, targeting smoldering neuroinflammation, which is crucial for addressing disability accumulation in MS [3]. - Currently, there are no approved therapies for nrSPMS, highlighting a significant unmet need that tolebrutinib could potentially fulfill [4]. Group 3: Stock Performance and Future Studies - Year-to-date, Sanofi's shares have increased by 16%, outperforming the industry average growth of 6% [7]. - Sanofi is also evaluating tolebrutinib in a phase III study for primary progressive MS, with data expected in the second half of 2025 [8]. Group 4: Previous Clinical Holds - In 2022, the FDA placed a partial clinical hold on Sanofi's phase III studies for tolebrutinib due to cases of drug-induced liver injury observed in participants [9]. - The studies for myasthenia gravis (MG) indications were eventually discontinued after evaluating the competitive treatment landscape [10].