Regeneron Pharmaceuticals (REGN) Q1 2026 earnings summary

Executive summary

• Q1 2026 revenues rose 19% year-over-year to $3.61 billion, driven by strong Dupixent and EYLEA HD sales, with non-GAAP EPS up 15% to $9.47 and GAAP EPS at $6.75, both impacted by IPR&D charges.

• Significant regulatory milestones included FDA approvals for EYLEA HD (extended dosing), Dupixent (new indications), and Otarmeni (gene therapy for hearing loss), plus progress in gene therapy and rare disease programs.

• EYLEA HD offset declines in EYLEA due to biosimilar competition; Dupixent collaboration revenue grew significantly.

• Entered Most-Favored-Nation pricing agreements with the U.S. government and secured tariff exemptions through January 2029.

• New $3 billion share repurchase program authorized, with $803 million repurchased in Q1.

Financial highlights

• Q1 2026 total revenues reached $3.61 billion, up 19% year-over-year; net income was $727 million, down 10%, and non-GAAP net income was $1.04 billion, up 12%.

• Diluted non-GAAP EPS was $9.47; GAAP EPS was $6.75.

• Gross margin on net product sales was 76% (GAAP), down from 81% due to a temporary manufacturing interruption; non-GAAP gross margin was 86%.

• Dupixent global net sales (recorded by Sanofi) were $4.9 billion, up 33% year-over-year; EYLEA HD U.S. net sales were $468 million, up 52%.

• Free cash flow was $848 million for Q1 2026; cash and equivalents at quarter-end were $2.96 billion.

Outlook and guidance

• Guidance for 2026 remains unchanged for R&D ($6.45–$6.68B GAAP; $5.9–$6.1B non-GAAP) and SG&A ($2.86–$3.04B GAAP; $2.5–$2.65B non-GAAP).

• Expect full reimbursement of Sanofi development balance by end of Q2 2026, increasing collaboration revenue in Q3.

• Anticipate regulatory decisions for EYLEA HD prefilled syringe and other pipeline assets in 2026.

• Gross margin expected at 79–80% (GAAP) and 83–84% (non-GAAP); effective tax rate 12–14% (GAAP), 13–15% (non-GAAP).

• Guidance excludes impact of future business development transactions.