Sanofi (NasdaqGS:SNY) Update / Briefing December 16, 2025 11:15 AM ET Speaker0Good afternoon and good morning, depending on where you are, and welcome to Sanofi's first year-end late-stage pipeline review. I'm Thomas Kudsk Larsen from the Investor Relations team, and I'm pleased to see so many people on the call today. Before we get started, I want to thank Alizé and the IR team for leading the work on today's call. I also want to remind everyone that our focus is on the clinical and regulatory aspects of t ...

Core Insights - Merck is approaching a significant patent cliff with its leading PD-L1 therapy Keytruda, which is set to lose exclusivity in 2028, accounting for over 50% of the company's pharmaceutical sales and generating $23.3 billion in sales during the first nine months of 2025, an 8% increase year over year [1][9] Product Developments - The FDA approved a subcutaneous formulation of Keytruda, known as Keytruda Qlex, in September 2025, which has its own patents extending beyond 2028, potentially mitigating the impact of Keytruda's loss of exclusivity [2] - Merck is diversifying its portfolio with new products like the 21-valent pneumococcal conjugate vaccine Capvaxive and the pulmonary arterial hypertension (PAH) drug Winrevair, both of which have shown strong sales performance [3][4] - Capvaxive generated $480 million in sales in the first nine months of 2025, while Winrevair achieved $976 million in the same period, with management optimistic about their long-term revenue potential [4][5] Competitive Landscape - The PAH market remains highly competitive, with significant players like United Therapeutics and Johnson & Johnson posing challenges for Winrevair [8][10] - Merck's new RSV antibody Enflonsia faces competition from AstraZeneca/Sanofi's Beyfortus and several approved vaccines for RSV prevention [11] Financial Performance - Year-to-date, Merck's shares have increased by 2.9%, underperforming the industry average of 15.6% [12] - Merck's price/earnings ratio stands at 11.59, which is lower than the industry average of 16.91 and its 5-year mean of 12.54, indicating attractive valuation [13] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share has slightly increased from $8.94 to $8.98, while the estimate for 2026 has decreased from $9.55 to $8.81 over the past 60 days [15]

Core Insights - Merck's Gardasil vaccine is experiencing significant sales declines, particularly in China and Japan, with a projected negative compound annual growth rate (CAGR) of 18.1% over the next three years [1][4] Sales Performance - Gardasil sales fell by 3% in 2024 and 40% year-over-year in the first nine months of 2025, primarily due to weak demand in China and Japan [1][9] - The economic slowdown in China has led to higher-than-normal inventory levels for Merck's partner, Zhifei, prompting Merck to halt shipments of Gardasil in China until at least the end of 2025 [2][3] Competitive Landscape - Merck's other vaccines, including ProQuad, M-M-R II, Varivax, RotaTeq, and Pneumovax 23, also saw sales declines in the first nine months of 2025 [6][9] - Merck's new RSV antibody, Enflonsia, recorded $79 million in sales in Q3 2025 but faces competition from AstraZeneca/Sanofi's Beyfortus, which achieved €1.09 billion in sales in the same period, up 33.8% year-over-year [6][7] Valuation and Market Performance - Year-to-date, Merck's shares have increased by 6.3%, underperforming the industry average of 15.9% [8] - Merck's price-to-earnings ratio stands at 11.97, lower than the industry average of 16.98 and its 5-year mean of 12.56, indicating a potentially attractive valuation [10] Earnings Estimates - The Zacks Consensus Estimate for Merck's 2025 earnings per share has slightly increased from $8.94 to $8.98, while the estimate for 2026 has decreased from $9.56 to $8.81 over the past 60 days [11]

Investment Rating - The industry investment rating is "Outperform the Market" [40] Core Insights - Sanofi reported Q3 2025 revenue of €12.43 billion ($14.45 billion), a year-on-year increase of 7%, driven primarily by the immunology sector and new product sales [5][14] - Dupixent (dupilumab) sales exceeded €4 billion in a single quarter for the first time, reaching €4.156 billion, a 26% year-on-year growth [25] - The overall gross margin improved to 78.9%, up 2.3 percentage points from the previous year, due to a higher proportion of high-margin products and increased capacity utilization [5][14] Summary by Sections Part 1: Q3 2025 Financial Overview and Key Events - Q3 2025 net sales were €12.43 billion, with a gross profit of €9.82 billion and a gross margin of 78.9% [12][14] - R&D expenses were €1.834 billion, a 4.9% increase year-on-year, while net income rose to €3.547 billion, up 9.8% [5][12] Part 2: Core Product Sales Analysis - Dupixent accounted for 33.4% of Sanofi's total revenue in Q3 2025, with sales in the U.S. reaching €3.073 billion, a 27.9% increase [25] - New product sales totaled €1.805 billion, a 40.8% increase year-on-year, contributing 15% to total sales [31] - Vaccine sales declined by 7.8% to €3.4 billion, primarily due to competitive pricing pressures and weak flu vaccination rates in North America [31] Part 3: Future Pipeline Milestones - Key upcoming milestones include regulatory submissions for Dupixent for allergic fungal sinusitis and other products [36] - Two products received regulatory approval: Wayrilz for ITP in the U.S. and Tzield for delaying type 1 diabetes progression in China [17][36]

Core Insights - Sanofi reported third-quarter 2025 adjusted earnings of $1.70 per American depositary share, exceeding the Zacks Consensus Estimate of $1.60, with earnings of €2.91 per share reflecting a 7% increase on a reported basis and a 13.2% increase on a constant currency rate basis, attributed to cost control and operational efficiency [1][10] - Net sales increased by 2.3% on a reported basis to $14.52 billion (€12.43 billion), with a 7% rise on a constant currency basis, slightly surpassing the Zacks Consensus Estimate of $14.46 billion [1][10] Sales Performance - Sales in the United States rose by 11.1% at constant currency, 1.9% in the Rest of the World, and 2.8% in Europe [2] - Dupixent sales reached €4.2 billion, up 26.2% year over year, driven by strong prescription trends across all approved indications and geographies, surpassing the model estimate of €4.03 billion [3][10] - Altuviiio, a rare blood disorder drug, recorded sales of €294 million, up 81.4% year over year, primarily due to patient switches in the U.S. hemophilia A market [6] - Nexviazyme/Nexviadzyme sales were €200 million, up 27.6% year over year, while Myozyme sales declined by 25% to €122 million [7] - Cablivi sales increased by 9.5% to €66 million, while Eloctate sales fell by 14.6% to €77 million due to patient switches to Altuviiio [8] Vaccine Sales - Total vaccine sales declined by 7.8% to €3.36 billion, mainly due to lower flu vaccine sales, which dropped by 16.8% year over year to €1.53 billion [14][15] - Sales of AstraZeneca-partnered Beyfortus rose by 19.8% to €739 million, driven by geographical roll-out in Europe and the Rest of the World [16] Future Outlook - Sanofi maintained its 2025 sales and earnings growth expectations, anticipating a high single-digit percentage increase in sales and low double-digit percentage growth in earnings at constant currency [17][18] - The company has repurchased 86.1% of its €5 billion buyback program and plans to complete it this year [17] - Sanofi expects three potential new drug launches this year, with Qfitlia and Wayrilz already launched [21] - The company has been active in M&A, acquiring Blueprint Medicines and Vigil Neuroscience to enhance its presence in rare immunological diseases and neurology [22]

Core Insights - Merck (MRK) is set to report its third-quarter 2025 results on October 30, with a focus on the sales performance of its leading cancer drug, Keytruda, which contributed over 50% of the company's pharmaceutical sales in the first half of 2025 [1][9] - The company is also monitoring the performance of its non-oncology drugs, particularly the newly approved 21-valent pneumococcal conjugate vaccine, Capvaxive, and the pulmonary arterial hypertension (PAH) drug, Winrevair, both of which showed strong sales in the first half of 2025 [2][9] Sales Performance - Keytruda remains a significant revenue driver, but its exclusivity is set to expire in 2028, prompting investors to pay attention to non-oncology products [2] - Capvaxive generated sales of $236 million, while Winrevair achieved $615 million in sales during the first half of 2025 [2] Growth Projections - The new drugs are expected to perform well in Q3 2025, supported by their strong initial uptake [3] - Merck's Animal Health business is also contributing to revenue growth, with an estimated compound annual growth rate (CAGR) of 5.9% over the next three years [3] Product Launches and Approvals - Merck's RSV antibody, Enflonsia, was approved in the U.S. in June 2025 and is under review in the EU, with plans for launch to protect infants during their first RSV season [4] - A fixed-dose combination for HIV treatment is also under review, with an FDA decision expected in April next year [4] Competitive Landscape - Winrevair faces competition in the PAH market from major players like United Therapeutics and Johnson & Johnson, which reported significant revenues from their PAH products [5][6] - Enflonsia will compete with AstraZeneca/Sanofi's RSV antibody, Beyfortus, and other vaccines approved for RSV prevention [6][7] Stock Performance and Valuation - Year-to-date, Merck's shares have declined by 12.3%, underperforming the industry and the S&P 500 [8] - The company's shares trade at a price/earnings ratio of 9.33, which is lower than the industry average of 15.56 and its 5-year mean of 12.63, indicating attractive valuation [10] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share has slightly decreased from $8.94 to $8.92, while the estimate for 2026 has decreased from $9.55 to $9.44 over the past 60 days [11]

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]

Financial Data and Key Metrics Changes - In Q3 2025, the company reported sales of EUR 12.4 billion, representing a 7% increase compared to the previous year [4] - Business EPS reached EUR 2.91, reflecting a robust growth of EUR 0.19 or 13% compared to Q3 2024 [15] - The gross margin increased by 2.3 percentage points this quarter, driven by an improved product mix and productivity gains [13] Business Line Data and Key Metrics Changes - Pharmaceutical sales grew by 7% at constant exchange rates, primarily driven by immunology and recent launches [13] - New product launches contributed EUR 1.8 billion in sales this quarter, accounting for 15% of total sales [6] - Dupixent sales reached EUR 4 billion for the first time, with a 26% growth this quarter [7][15] Market Data and Key Metrics Changes - Vaccine sales were EUR 3.4 billion, reflecting a decrease due to competitive price pressure and lower flu immunization rates in the U.S. [8] - Outside the U.S., Dupixent sales grew by 21%, exceeding EUR 1 billion in the quarter [8] - Beyfortus sales increased by 20% this quarter, now available in 40 countries [9] Company Strategy and Development Direction - The company aims to improve access to treatments and lower prices for patients, as demonstrated by the expansion of its patient affordability program for insulins [5][11] - The focus remains on innovation in respiratory vaccines and expanding the commercial portfolio with new product launches [10][11] - The company is committed to maintaining a balanced capital allocation policy, focusing on organic growth, selective acquisitions, and progressive dividends [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business outlook for the remainder of the year and reiterated full-year sales guidance [4] - The company anticipates continued growth momentum, with expectations for high single-digit sales growth and low double-digit business EPS growth at constant exchange rates for the full year [15][16] - Management acknowledged challenges in the vaccine segment but remains committed to innovation and improving patient access [10][11] Other Important Information - The company has achieved a milestone of treating 1 million patients for non-communicable diseases across low and middle-income countries since 2021 [11] - The company has completed acquisitions of Drensbios DR0201, Vigil Neuroscience, and Blueprint, with associated costs factored into guidance [15] Q&A Session Summary Question: Update on Poly-SPMS regulatory debate and confidence in resolving FDA questions - Management confirmed ongoing conversations with the FDA and submitted data sets, looking forward to the PDUFA date of December 28 [32] Question: Update on U.S. policy conversations - Management stated that dialogues with the U.S. government have been ongoing and focused on demonstrating the value the company can bring [38] Question: Q4 ordering trends for Beyfortus - Management confirmed expectations for Q4 performance to be similar to Q3, with a focus on increasing vaccination coverage rates in the U.S. [42][44] Question: Insights on Dupixent's COPD development and gross to net dynamics - Management highlighted strong growth in COPD and indicated that gross to net dynamics are monitored and included in long-term guidance [81] Question: Timing dynamics around riliprubart and other programs under review - Management indicated that timelines for riliprubart are being updated and that data from various studies will be presented at relevant scientific congresses [62] Question: Potential for product acquisitions and vaccine trends - Management acknowledged the success of Dupixent and indicated a cautious approach to M&A, while also addressing concerns about vaccine fatigue [90]

Financial Performance - Q3 2025 sales reached €12434 billion, a 7% increase at CER (constant exchange rates)[17, 51] - Dupixent sales exceeded €4 billion for the first time in a quarter, growing by 262%[17, 25] - Pharma launches contributed 15% of sales, totaling €1805 million, a 408% increase at CER[21, 22] - Vaccines sales decreased by 78% to €1525 billion, impacted by lower influenza sales[17, 30] - Business EPS increased by 132%, reflecting operating income growth and share buyback[56] Pipeline Highlights - Wayrilz was approved for ITP (Immune Thrombocytopenia) in the US[69, 70] - Amlitelimab met primary endpoints in the AD (Atopic Dermatitis) phase 3 study[69, 77] - Fluzone HD met the primary endpoint in the influenza 50 years+ phase 3 study[69] 2025 Outlook - The company anticipates a mid-teens percentage decline in Flu vaccines sales for full-year 2025[59] - The company expects divestments of other medicines to impact sales by approximately €200 million[59] - The company anticipates capital gains from divestments of approximately €500 million[60]

Core Insights - Merck is experiencing significant challenges with its second-largest product, Gardasil, which is a vaccine for preventing certain cancers caused by human papillomavirus. Sales, which had been rising until 2022, began to decline in 2024 and continued to struggle in 2025 [1][10]. Sales Performance - In the first half of 2025, Gardasil sales dropped 48% year-over-year to $2.45 billion, primarily due to weak demand in China amid an economic slowdown. This decline has led to higher-than-normal inventory levels at Merck's partner in China, Zhifei [2][10]. - Merck has decided to temporarily halt shipments of Gardasil to China to allow for inventory reduction, with no expected resumption of shipments until at least the end of 2025. Sales are projected to decline significantly in 2025 compared to 2024 levels [3][10]. - Demand for Gardasil is also weak in Japan, with expectations of continued low sales in both China and Japan for the latter half of 2025. Estimates suggest a negative compound annual growth rate (CAGR) of 15.1% for Gardasil sales over the next three years [4]. Other Vaccines and Competitive Landscape - Besides Gardasil, Merck markets several other vaccines, including ProQuad, M-M-R II, Varivax, Vaxneuvance, RotaTeq, Pneumovax 23, and the newly approved Capvaxive [5]. - Sales of other vaccines, such as ProQuad and Pneumovax 23, also saw declines in the first half of 2025. Merck's new RSV antibody, Enflonsia, was approved in the U.S. in June 2025 and is under review in the EU, aimed at protecting infants during their first RSV season [6]. - Enflonsia is the first treatment designed to protect infants with a uniform dose regardless of weight, but it faces competition from AstraZeneca and Sanofi's RSV antibody, Beyfortus, which achieved blockbuster status in its first full year of sales in 2024 [7][8]. Financial Performance and Valuation - Year-to-date, Merck's shares have declined by 15.8%, underperforming the industry, sector, and S&P 500 [9]. - From a valuation perspective, Merck's shares trade at a forward price/earnings ratio of 8.97, which is lower than the industry average of 15.62 and its 5-year mean of 12.64 [11]. - The Zacks Consensus Estimate for 2025 earnings per share has decreased from $8.94 to $8.92, and for 2026, it has decreased from $9.55 to $9.44 over the past 60 days [12].