Regeneron Pharmaceuticals (REGN) Q4 2025 earnings summary

Executive summary

• Q4 2025 revenues rose 3% year-over-year to $3.9B, driven by strong sales of Dupixent (+34%), Libtayo (+16%), and EYLEA HD (+66%), with continued leadership in branded anti-VEGF and immunology markets.

• Dupixent global net sales reached $4.9B in Q4 and $17.8B for the year, expanding across eight indications and treating over 1.4 million patients globally.

• Libtayo global net sales were $425M in Q4 and $1.45B for 2025, with new adjuvant CSCC indication and approvals in the U.S. and Europe.

• EYLEA HD U.S. net sales were $506M in Q4 (up 66%) and $1.6B for the year (up 36%), with recent FDA and EC approvals for new indications and dosing options.

• Key regulatory approvals and label expansions for EYLEA HD, Dupixent, and Libtayo in the U.S., EU, and Japan, with strong commercial execution and pipeline progress positioning for continued growth in 2026.

Financial highlights

• Q4 2025 total revenues were $3.9B, with non-GAAP EPS of $11.44 and GAAP net income of $845M; full year GAAP net income was $4.5B.

• Free cash flow for 2025 was $4.1B; cash and marketable securities at year-end totaled $18.9B.

• Returned $3.8B to shareholders in 2025, including $3.4B in share repurchases and nearly $400M in dividends.

• Gross margin guidance for 2026 is 83%-84% (non-GAAP); GAAP gross margin expected at 79%-80%.

• Q4 2025 GAAP EPS was $7.86 (down 2%); non-GAAP EPS was $11.44 (down 5%).

Outlook and guidance

• Anticipates at least four FDA approvals in 2026, including three new molecular entities and EYLEA HD prefilled syringe.

• Plans to initiate 18 additional Phase III studies in 2026, targeting 35,000 patients.

• 2026 R&D spend expected to be $5.9B-$6.1B (non-GAAP); SG&A $2.5B-$2.65B; capital expenditures $1.1B-$1.3B.

• Effective tax rate for 2026 projected at 13%-15% (non-GAAP); GAAP at 12%-14%.

• Key 2026 milestones include regulatory decisions for EYLEA HD PFS, Dupixent in BP and AFRS, and NDA submission for cemdisiran in gMG.