Regeneron Pharmaceuticals Stock Earnings Reports

Regeneron reported a solid Q3 2025 driven by strong growth in key commercial products and substantial pipeline momentum. Commercial highlights: Dupixent global net sales (as recorded by Sanofi) were $4.9 billion, up ~26% YoY (constant currency), with >1.3 million patients on therapy and broad label expansion potential. Libtayo sales reached $365 million (+24% CC), including a recent FDA approval in the adjuvant high‑risk cutaneous squamous cell carcinoma setting. EYLEA HD U.S. net sales hit a record $431 million (unit demand +18% QoQ) but overall EYLEA/EYLEA HD performance faces affordability and pricing pressures; a CRL was issued for the prefilled‑syringe sBLA tied solely to unresolved inspection findings at a contract filer (Catalent), and Regeneron is pursuing alternate fillers and resubmissions with potential near‑term opportunities (PDUFA/filing opportunities late Dec/Jan). Financial highlights: total revenues were $3.8 billion (+1% YoY), diluted EPS $11.83, gross margin on net product sales 86%, R&D spend increasing as Regeneron accelerates late‑stage programs, $3.2 billion free cash flow YTD and ~ $16 billion cash/net securities less debt. The company repurchased ~$2.8 billion YTD and expects to return ~ $4 billion to shareholders in 2025 via repurchases and dividends. The Sanofi development balance has materially declined and is expected to be fully reimbursed by no later than Q3 2026. Pipeline/program highlights: multiple positive Phase III or registration‑enabling readouts across immunology, neurology, allergy and rare disease in the past quarter (including cemdisiran positive Phase III in gMG and Lynozyfic approvals in rrMM and EU), major registrational programs planned or ongoing in myeloma, lymphoma, Factor XI anticoagulation, obesity, siRNA programs (multiple CNS and metabolic targets), and ultra‑rare disease progress (garetosmab in FOP with >99% reduction in heterotopic bone formation; gene therapy for OTOF hearing loss preparing U.S. filing). Corporate/government: management is in constructive discussions with the U.S. administration on drug pricing and U.S. manufacturing support while emphasizing preserving U.S. biotech innovation. Guidance/near term: R&D expected to increase mid‑teens % in 2026; more detailed 2026 financial guidance to be provided early next year. Key near‑term catalysts include regulatory actions on EYLEA HD labeling/filling, cemetery/other sRNA submissions (cemdisiran filing planned Q1 2026), multiple pivotal readouts in oncology/anticoagulation/ophthalmology through 2026, and the inaugural Regeneron Roundtable investor event on Nov 10 (spotlighting Factor XI).