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8-K2026-04-29· qwen-plus

REGN · Regeneron Pharmaceuticals, Inc.

0000872589-26-000014

SEC filing

Summary

Regeneron reported first quarter 2026 total revenues of $3.605 billion (up 19% year-over-year) and GAAP EPS of $6.75, driven by strong Dupixent collaboration revenue growth and EYLEA HD U.S. net sales growth of 52%, partially offset by declining legacy EYLEA sales and lower gross margin due to a manufacturing interruption in Ireland.

Key takeaways

Full analysis

Regeneron’s Q1 2026 results reflect robust top-line growth anchored by Dupixent’s continued global expansion and successful commercialization of EYLEA HD, though legacy EYLEA sales declined sharply as patients transitioned to the higher-dose formulation. Total revenue grew 19% year-over-year to $3.605 billion, with Sanofi collaboration revenue surging 36% to $1.605 billion—driven by Dupixent’s 33% global net sales increase to $4.9 billion—and Libtayo global sales rising 54% to $438 million. However, GAAP net income fell 10% to $727 million and GAAP EPS declined 7% to $6.75, primarily due to $102 million in acquired IPR&D expenses and a 5-percentage-point contraction in GAAP gross margin (76% vs. 81% in Q1 2025), stemming from unabsorbed manufacturing costs and inventory write-offs tied to a temporary bulk production interruption at Regeneron’s Limerick, Ireland facility. Non-GAAP metrics showed stronger underlying performance: non-GAAP net income rose 12% to $1.040 billion and non-GAAP EPS increased 15% to $9.47, underscoring operational leverage despite elevated R&D investment (+16% YoY to $1.544 billion). Management highlighted disciplined capital allocation—including $803 million in Q1 share repurchases and a newly authorized $3.0 billion buyback program—as well as strategic progress across the pipeline, including FDA approvals for Otarmeni (the first gene therapy for OTOF-related hearing loss, offered free in the U.S.), expanded Dupixent indications, and EYLEA HD’s landmark 5-month dosing interval extension. The company also disclosed ongoing regulatory engagements, including pending FDA decisions on EYLEA HD pre-filled syringe manufacturing and garetosmab for FOP, reinforcing near-term catalysts beyond earnings.