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The earnings call conveyed a predominantly positive operational and financial picture: strong double-digit revenue and EPS growth, robust performance of core growth drivers (DUPIXENT, EYLEA HD, Libtayo), meaningful pipeline and regulatory milestones (including a gene therapy approval and encouraging Phase III data), a healthy balance sheet and active capital return via buybacks. The principal negatives were product-specific pressures (notably a steep decline in legacy EYLEA sales due to conversion, competition and inventory effects), a temporary manufacturing interruption that reduced GAAP margins and a missed FDA action on an EYLEA HD fill-finish application that creates near-term regulatory timing uncertainty. Overall, the call emphasized execution, pipeline progress and financial strength, with manageable near-term operational and regulatory headwinds.
Regeneron made only modest changes to its 2026 outlook, most notably updating GAAP gross‑margin guidance to 77–78% (Q1 GAAP gross margin was 76% and Q1 non‑GAAP gross margin on net product sales was 86%) while warning of a Q2 drag from a temporary Limerick manufacturing interruption as full production resumes by end‑Q2; management also said the Sanofi development balance should be fully repaid by end‑Q2, with Regeneron receiving its full share of collaboration profits starting in Q3. In Q1 the company reported total revenues up 19% to $3.6 billion, non‑GAAP diluted EPS up 15% to $9.47 (net income $1.0 billion), $848 million of free cash flow, cash and marketable securities less debt of $15.8 billion, $800 million of share repurchases in the quarter and a new $3.0 billion buyback authorization (about $3.4 billion available), R&D spend of $1.4 billion and SG&A of $560 million. Management also gave timing guidance for key regulatory and commercial milestones: they expect an FDA decision on one or both EYLEA HD prefilled‑syringe filings this quarter, see cemdisiran’s FDA decision in Q4, have a garetosmab PDUFA date in August, expect cemdisiran PNH registrational results late Q4, and reiterated commercial expectations including EYLEA HD U.S. net sales of $468 million (52% YoY) with ~10% sequential unit demand growth in Q1 and similar growth expected in Q2, combined EYLEA/EYLEA HD U.S. net sales of $942 million, a roughly $20 million negative Q2 impact to EYLEA net sales from inventory absorption, DUPIXENT net sales of $4.9 billion (31% CC growth), and Libtayo global net sales of $438 million (54% YoY).
Total revenues rose 19% year-over-year to $3.6 billion in Q1 2026; non-GAAP diluted net income per share increased 15% to $9.47 and net income was $1.0 billion, demonstrating double-digit growth across revenues and earnings.
Global DUPIXENT net sales grew 31% (constant currency) to $4.9 billion in the quarter and the franchise reported annualized global net sales near $20 billion, with broad-based demand across indications and geographies.
EYLEA HD U.S. net product sales increased 52% year-over-year to $468 million; combined U.S. EYLEA/EYLEA HD net sales were $942 million and physician demand for EYLEA HD rose sequentially ~10% in Q1.
Global Libtayo product sales grew 54% year-over-year to $438 million, driven by uptake in advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer as well as early contributions from adjuvant CSCC.
FDA approval of Otarmeni (gene therapy for genetic hearing loss) with the company committing to make it available for free; positive Phase III data for cemdisiran in generalized myasthenia gravis with an expected FDA decision in Q4; garetosmab BLA accepted with priority review (PDUFA August 2026); olatorepatide Phase II China data showed up to 19% mean body weight loss at week 48.
First-quarter Sanofi collaboration revenues were $1.6 billion, with Regeneron’s share of collaboration profits up 42% versus prior year; other revenue grew 109% to $171 million (including $101 million from ARCALYST share and Ilaris royalties). Sanofi development balance expected to be fully repaid by end of Q2, with Regeneron to recognize full share of profits starting in Q3.
Generated $848 million of free cash flow in Q1; cash and marketable securities less debt of $15.8 billion at quarter end; repurchased $800 million of stock in Q1 and Board authorized a new $3.0 billion share repurchase program (approximately $3.4 billion available).
Non-GAAP gross margin on net product sales was strong at 86% in Q1, reflecting favorable product mix and high-margin portfolio performance.
Welcome to the Regeneron Pharmaceuticals First Quarter 2026 Earnings Conference Call. My name is Kevin, and I'll be your operator for today's call. [Operator Instructions] Please note this conference is being recorded. I will now turn the call over to Ryan Crowe, Senior Vice President, Investor Relations. You may begin.
Thank you, Kevin. Good morning, good afternoon and good evening to everyone listening around the world. Thank you for your interest in Regeneron and welcome to our first quarter 2026 earnings conference call. An archived and transcript of this call will be available on the Regeneron Investor Relations website shortly after our call concludes. Joining me on today's call are Dr. Leonard Schleifer, Board Co-Chair, Co-Founder, President and Chief Executive Officer; Dr. George Yancopoulos, Board Co-Chair, Co-Founder, President and Chief Scientific Officer; Marion McCourt, Executive Vice President of Commercial; and Chris Fenimore, Executive Vice President and Chief Financial Officer. After our prepared remarks, the remaining time will be available for Q&A.
I would like to remind you that remarks made on today's call may include forward-looking statements about Regeneron. Such statements may include, but are not limited to, those related to Regeneron and its products and business, financial forecast and guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement changes to drug pricing regulations and requirements and our drug pricing strategy, intellectual property, pending liti...