Regeneron Pharmaceuticals (REGN) investor relations material

Executive summary

• Q3 2025 revenues were $3.75B, with GAAP net income up 9% to $1.46B and non-GAAP EPS at $11.83, driven by strong Dupixent, EYLEA HD, and Libtayo performance, despite a sharp EYLEA U.S. decline from biosimilar competition.

• Four blockbuster products, a robust pipeline of ~45 candidates, and a strong financial position support continued growth.

• Strategic focus on R&D, capital returns, and business development, with over $5B invested in R&D in 2025+ and $2.8B in share repurchases YTD.

• Cash flow from operations for the nine months ended September 30, 2025, was $3.8B, up 21% year-over-year, supporting ongoing share repurchases and dividends.

• Significant regulatory approvals and pipeline progress, including positive Phase 3 results in myasthenia gravis, FOP, and allergy programs.

Financial highlights

• Q3 2025 total revenues reached $3.75B; net income was $1.46B (+9% YoY); diluted GAAP EPS: $13.62 (+18%); non-GAAP EPS: $11.83 (-5%).

• Dupixent global net sales (Sanofi) up 27% YoY to $4.86B; Regeneron's share of profits: $1.46B (+34%).

• EYLEA HD U.S. Q3 sales: $431M (+10%); EYLEA U.S. Q3 sales: $681M (-41%).

• Libtayo Q3 2025 worldwide net sales were $365M (+26% YoY), surpassing $1B YTD.

• Gross margin on net product sales: 82% in Q3 2025 (down from 87% in Q3 2024).

Outlook and guidance

• Full reimbursement of Sanofi development balance expected by end of Q3 2026, driving significant growth in collaboration revenue.

• Management expects continued pressure on EYLEA sales due to biosimilar launches, but EYLEA HD and Dupixent growth to partially offset declines.

• Full-year 2025 guidance: GAAP R&D $5.68–$5.75B, non-GAAP R&D $5.10–$5.20B, GAAP SG&A $2.81–$2.94B, non-GAAP SG&A $2.40–$2.45B.

• Capital expenditures for 2025 guided at $1.0–$1.05B.

• Key 2025 milestones include regulatory submissions, pivotal data readouts, and expansion into obesity and genetic medicines.