Sanofi (NasdaqGS:SNY) Q4 2025 Earnings call January 29, 2026 08:30 AM ET Company ParticipantsBen Jackson - VP of Equity ResearchBrian Foard - EVP and Head of Specialty CareDavid Reed Risinger - Senior Managing DirectorFrançois-Xavier Roger - CFOGraham Parry - Managing Director and Head of European Pharmaceuticals Equity researchHouman Ashrafian - EVP and Head of Research and DevelopmentJames Gordon - Director and Head of European Pharma, Biotech & Life Sciences Equity ResearchJames Quigley - Executive Direc ...

Core Insights - The company reported a Q4 sales growth of 13.3% at constant exchange rates (CER) and a business earnings per share (EPS) of €1.53, reflecting strong performance driven by new medicines and Dupixent [1][2]. Sales Performance - In Q4 2025, net sales reached €11.3 billion, marking a 7.0% increase year-over-year at actual exchange rates and a 13.3% increase at CER [5]. - For the full year 2025, net sales totaled €43.6 billion, with a 6.2% increase at actual exchange rates and a 9.9% increase at CER [5]. Earnings Performance - Business EPS for Q4 2025 was €1.53, up by 16.8% at actual exchange rates and 26.7% at CER [5]. - The full year 2025 business EPS improved to €7.83, reflecting a 10.0% increase at actual exchange rates and a 15.0% increase at CER [5]. Product Developments - The company launched three new medicines and vaccines in 2025, contributing to sales growth [3]. - Dupixent sales increased by 32.2% to €4.2 billion, while pharmaceutical launches increased sales by 49.4%, reaching €1.1 billion [4]. Regulatory Approvals and R&D - The company obtained ten regulatory approvals across various therapeutic areas, including immunology and rare diseases [4]. - Research and Development expenses reached €2.3 billion, up by 6.6%, indicating continued investment in innovation [4]. Future Guidance - For 2026, the company expects sales to grow by a high single-digit percentage at CER, with business EPS anticipated to grow slightly faster than sales [2][4]. - A share buyback program of €1 billion is planned for 2026 [2]. Financial Management - The company completed a €5 billion share buyback program and proposed a dividend of €4.12, up by 5.1% [4]. - Free cash flow for Q4 2025 was €2.6 billion, reflecting a 12.7% increase [5].

Key Takeaways FOLD stands out after agreeing to a $14.50-per-share buyout by BioMarin, expected to be closed in Q2 2026.FOLD's Galafold drove over 80% of sales in 9M 2025, while Pombiliti plus Opfolda showed strong initial growth.RIGL's revenues are powered by Tavalisse, with added momentum from Rezlidhia and newly acquired Gavreto.Amicus Therapeutics (FOLD) and Rigel Pharmaceuticals (RIGL) appeal to growth-focused investors as they target rare diseases, where small patient populations can still support str ...

R&D Leadership and Organization - Sanofi is building a skilled and thoughtful R&D leadership team and organization[5, 6, 7, 106] - The company is strengthening capabilities across research, translational medicines, development, medical, regulatory affairs, and digital[106] Pipeline Highlights and Approvals - Sanofi achieved three new medicine and vaccine approvals in 2025: Qfitlia, Wayrilz, and Nuvaxovid[12, 13, 106] - Dupixent showed benefit across relevant endpoints in Bullous pemphigoid, with 12.2% difference in patients achieving sustained remission compared to placebo + OCS and 27.8% difference in patients with ≥4-point improvement in PP-NRS[20, 21] - Dupixent clinically meaningfully improved radiographic, endoscopic, and symptoms of Allergic fungal rhinosinusitis, with lower proportion of patients receiving SCS treatment and/or surgery[24] - Amlitelimab (OX40L mAb) in AD: first phase 3 study met primary and key secondary endpoints, showing clinically meaningful improvement in skin clearance and disease severity[26] - Brivekimig (TNFaxOX40L Nanobody®) in HS: phase 2a study achieved primary objective, with 54% of participants achieving HiSCR75[28, 29] - Itepekimab (IL33 mAb) in COPD: AERIFY-1 study showed a significant reduction in moderate or severe exacerbations of 27.1% at Week 52 with Q2W dosing across EOS level[38] - Duvakitug (TL1A mAb) in CD/UC: positive and encouraging phase 2b data presented at ECCO 2025, with 48% clinical remission in Crohn's disease high dose group[46, 47] - Fluzone HD demonstrated superior protection vs standard-dose influenza vaccines against hospitalization in older adults, including a -31.9% reduction in laboratory confirmed influenza hospitalization[75] - Monovalent RSV (mRNA) vaccine showed 74.9% efficacy against RSV LRTD in a phase 2 study[80] Pipeline Replenishment and Digital Transformation - Sanofi is progressing on pipeline entries augmented by strategic business development[107] - The R&D digital plan aims at reducing cycle times across the R&D value chain by more than 40%[94, 95, 107] Upcoming News Flow - Sanofi anticipates >15 regulatory decisions, >30 regulatory submissions, and >15 phase 3 data readouts in 2026 and 2027[108]

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]

Core Insights - The company reported a Q3 sales growth of 7.0% at constant exchange rates (CER) and a business earnings per share (EPS) of €2.91, reflecting a strong performance despite a high base of comparison from the previous year [1][4][5] Sales Performance - Newly launched medicines and vaccines contributed significantly, with a growth of 40.8% [4] - Dupixent sales increased by 26.2%, surpassing €4 billion in quarterly global sales for the first time, and €3 billion in the US [4][5] - Overall, IFRS net sales reported for Q3 2025 were €12,434 million, a 2.3% increase, while year-to-date (YTD) sales reached €32,323 million, up 5.9% [8] Financial Metrics - Business EPS rose by 13.2% at CER and 7.0% at actual exchange rates, reaching €2.91 [5][6] - Business operating income for Q3 was €4,445 million, up 2.7%, with a YTD increase of 5.9% [8] - Free cash flow for Q3 was reported at €2,994 million, a decrease of 6.1%, while YTD free cash flow was €5,452 million, an increase of 50.8% [8] Research and Development - The company achieved two regulatory approvals: Wayrilz in the US for immune thrombocytopenia and Tzield in China for delaying the onset of stage 3 type 1 diabetes [7] - Positive phase 3 readouts were reported for amlitelimab in atopic dermatitis and Fluzone HD for influenza in patients aged 50 and above [7] - The company initiated three new phase 3 studies and received three new regulatory designations [7] Strategic Initiatives - The acquisition of Vigil Neuroscience was completed, enhancing the early-stage pipeline [8] - The company committed an additional $625 million to Sanofi Ventures, focusing on innovative biotech and digital health investments [5] - A €5 billion share buyback program is set to be completed by the end of 2025, with 86.1% executed to date [5][8] Guidance and Outlook - The company anticipates high single-digit sales growth at CER for 2025 and a strong business EPS rebound with low double-digit growth at CER before share buyback [4][6]

Core Insights - Rigel Pharmaceuticals (RIGL) is advancing its hematology and oncology pipeline, with Tavalisse being the primary revenue driver [1][2] Product Performance - Tavalisse, an oral spleen tyrosine kinase inhibitor, generated sales of $68.5 million in the first half of 2025, reflecting a 44% year-over-year increase [2][10] - Rezlidhia, the second FDA-approved product, reported sales of $13.1 million in the same period, up 31% year over year [3][10] - Gavreto was added to Rigel's portfolio in 2024, contributing incremental sales starting June 2024, which positively impacted the company's revenue in the first half of 2025 [5][10] Future Outlook - Rigel expects steady sales growth as it expands its commercial presence and enhances marketing efforts, projecting total revenues of $270-$280 million for 2025, up from a previous estimate of $200-$210 million [6] Pipeline Development - Rigel is conducting a phase Ib study for R289, a dual IRAK1 and IRAK4 inhibitor, in patients with lower-risk myelodysplastic syndrome (MDS), with plans to initiate the dose expansion phase in the second half of 2025 [8] - The company is also exploring Rezlidhia's application in other cancers with IDH1 mutations, which could serve as a significant growth catalyst [9] Competitive Landscape - The recent FDA approval of Sanofi's Wayrilz (rilzabrutinib) for chronic ITP poses a competitive threat to Tavalisse, despite differing mechanisms of action [11] - Other companies are also developing treatments that may compete with Rigel's marketed products, including Eli Lilly's Retevmo (selpercatinib) for cancer indications [12] Stock Performance and Valuation - Rigel's shares have increased by 70.2% year to date, outperforming the industry and the S&P 500 [13] - The company is trading at a price-to-sales (P/S) ratio of 1.94, below the industry average of 2.47 and its five-year mean of 2.21 [14] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share (EPS) has risen from $2.68 to $5.10 over the past 60 days, with 2026 EPS estimates increasing from $1.61 to $3.07 [17]

Core Insights - Rigel Pharmaceuticals (RIGL) shares have surged 76.7% over the past three months, driven by investor confidence in the growth of its lead drug, Tavalisse, and other marketed products [1][11]. Product Performance - Tavalisse, an oral spleen tyrosine kinase inhibitor, is FDA-approved for treating adult patients with chronic immune thrombocytopenia (ITP) who have had insufficient response to prior treatments. It is also approved in several other countries [2]. - In Q2 2025, Rigel's net product sales increased by 76.2% year over year, with Tavalisse accounting for over 65% of these sales, marking the company's best quarter ever [3][11]. - Tavalisse generated sales of $68.5 million in the first half of 2025, reflecting a 44% year-over-year increase, driven by strong new patient demand [4]. - Rigel's second FDA-approved product, Rezlidhia, indicated for relapsed/refractory acute myeloid leukemia (AML), saw sales increase by 31% year over year in the first half of 2025 [5]. - The company has also added Gavreto to its portfolio, which contributed to sales growth in the first half of 2025 [7]. Financial Guidance - Rigel has raised its total revenue guidance for 2025 to $270-$280 million, up from a previous estimate of $200-$210 million. Net product sales are now expected to be between $210-$220 million, compared to the earlier guidance of $185-$192 million [8][11]. Market Outlook - Sales are anticipated to grow steadily as Rigel expands its commercial footprint and enhances its marketing infrastructure, focusing on Tavalisse, Rezlidhia, and Gavreto [9]. - Rigel's stock has outperformed the industry and the S&P 500, with a year-to-date increase of 103.5% compared to the industry's 9.9% rise [16]. Valuation and Earnings Estimates - Rigel is currently trading at a price-to-sales (P/S) ratio of 2.32, which is lower than the industry average of 2.42 [17]. - The Zacks Consensus Estimate for 2025 earnings per share (EPS) has risen from $2.25 to $5.10 over the past 60 days, with 2026 EPS estimates increasing from $1.60 to $3.07 [20]. Pipeline Development - Rigel is developing additional candidates, including R289, a dual IRAK1 and IRAK4 inhibitor, which has received Orphan Drug designation for treating myelodysplastic syndromes [12][13].

Core Insights - Rigel Pharmaceuticals' primary revenue driver is Tavalisse, which is crucial for the company's top-line growth [1][3] Product Overview - Tavalisse is an FDA-approved oral spleen tyrosine kinase (SYK) inhibitor for adult patients with chronic immune thrombocytopenia (ITP) who have not responded adequately to previous treatments [2] - The drug is also approved in several regions including Europe, the UK, Japan, and others [2] Sales Performance - In the first half of 2025, Tavalisse generated sales of $68.5 million, reflecting a year-over-year increase of approximately 44% [3][10] - Continued strong demand from new patients is expected to sustain sales momentum into the second half of 2025 [3] Revenue Guidance - Rigel has raised its total revenue guidance for 2025 to a range of $270-$280 million, up from the previous estimate of $200-$210 million [6][10] - Net product sales are now projected to be between $210-$220 million, an increase from the earlier guidance of $185-$192 million [7] Competitive Landscape - The approval of Sanofi's Wayrilz (rilzabrutinib), a novel BTK inhibitor for ITP, poses a competitive threat to Tavalisse despite differing mechanisms of action [8] - Wayrilz is the first BTK inhibitor approved by the FDA for ITP treatment in the U.S. and is under review in the EU and China [8] Market Performance - Year-to-date, Rigel's shares have increased by 116.9%, significantly outperforming the industry average of 12.9% [9] - The stock is currently trading at a price-to-sales (P/S) ratio of 2.47, slightly below the industry average of 2.48 [11] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share (EPS) has risen from $2.25 to $5.10 over the past 60 days, with 2026 EPS estimates increasing from $1.60 to $3.07 [12] Company Ranking - Rigel currently holds a Zacks Rank 1 (Strong Buy), indicating strong market confidence [16]