Regeneron's Revenue Rises 4% in Q2 2025

Regeneron Pharmaceuticals, Inc. reported strong financial results for the second quarter of 2025, with total revenues increasing by 4% to $3.68 billion, up from $3.55 billion in Q2 2024. GAAP net income for the quarter was $1.39 billion, a 3% decrease compared to $1.43 billion in the same period last year. Diluted GAAP EPS rose by 3% to $12.81. The company's revenue of $3.68 billion fell short of the analyst estimate of $3.28 billion, while GAAP EPS of $12.81 significantly surpassed the analyst estimate of $8.03.

Key Business Drivers

Several products contributed to Regeneron's performance in the second quarter. U.S. net sales of EYLEA HD increased by 29% to $393 million, driven by higher sales volumes and increased demand. Dupixent global net sales, recorded by Sanofi, increased by 22% to $4.34 billion. Libtayo global net sales also saw significant growth, rising by 27% to $377 million, with U.S. sales up 36% and Rest of World sales up 12%. However, total U.S. net sales of EYLEA HD and EYLEA decreased by 25% to $1.15 billion, primarily due to competitive pressures, market share loss to compounded bevacizumab, and the ongoing transition of patients to EYLEA HD, along with a lower net selling price for EYLEA.

Management Commentary and Strategic Outlook

Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President, and Chief Executive Officer of Regeneron, highlighted the quarter's strong performance, noting significant growth in EYLEA HD U.S. sales and global sales of Dupixent and Libtayo, alongside multiple regulatory approvals. He emphasized progress in the oncology portfolio with the FDA approval of Lynozyfic for relapsed or refractory multiple myeloma and positive data supporting potential FDA approval for Libtayo in adjuvant CSCC. Dupixent continues to expand its indications, with recent FDA approvals for bullous pemphigoid and chronic spontaneous urticaria, demonstrating its leadership in type 2 inflammation diseases. The company remains confident in the near- and long-term potential of its diverse pipeline and anticipates additional data and regulatory milestones later this year.

Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer, reiterated satisfaction with the second quarter's financial results, pointing to 4% revenue growth and 12% non-GAAP earnings growth. He emphasized the company's commitment to both internal investments in its pipeline and returning capital to shareholders, having repurchased over $2.3 billion in shares and committed over $7 billion to U.S. manufacturing investments, capital expenditures, and business development since the start of 2025.

Pipeline Progress and Regulatory Updates

Regeneron's clinical development pipeline includes approximately 45 product candidates. In June 2025, the FDA approved Dupixent for adults with bullous pemphigoid, and in April 2025, for adults and adolescents aged 12 and older with chronic spontaneous urticaria. The European Commission approved EYLEA 8 mg for extended dosing in wAMD and DME. However, regulatory approvals for EYLEA HD (pre-filled syringe, every-four-week dosing, and RVO treatment) are expected to be delayed due to observations from an FDA site inspection at a filler, Catalent Indiana LLC. In oncology, Lynozyfic received accelerated FDA approval and conditional EC approval for relapsed or refractory multiple myeloma. The FDA also accepted a sBLA for Libtayo in adjuvant CSCC for priority review. The company also announced interim 26-week results from the Phase 2 COURAGE trial for obesity treatments, showing that combining semaglutide with trevogrumab preserved lean mass while increasing fat mass loss.