Sanofi (NasdaqGS:SNY) Q3 2025 Earnings Call October 24, 2025 08:30 AM ET Company ParticipantsThomas Triomphe - Head of VaccinesThomas Kudsk Larsen - Head of Investor RelationsHouman Ashrafian - Head of R&DBrian Foard - Head of General MedicinesPaul Hudson - CEOFrançois-Xavier Roger - CFOConference Call ParticipantsSarita Kapila - AnalystSachin Jain - AnalystRichard Vosser - AnalystFlorent Cespedes - AnalystSteve Scala - AnalystDavid Risinger - AnalystPeter Verdult - AnalystMichael Leuchten - AnalystSeamus F ...

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]