Regeneron Q1 2026 revenues rise 19% on Dupixent and new approvals
Regeneron Pharmaceuticals reported total revenues of $3.6 billion for the first quarter of 2026, a 19% increase on the same period last year, driven by surging demand for Dupixent and a flurry of regulatory approvals across its portfolio.
Non-GAAP net income per diluted share rose 15% to $9.47, while GAAP net income fell 10% to $727 million, partly reflecting $102 million in acquired in-process research and development (IPR&D) charges. The NASDAQ-listed company also authorised a new $3 billion share repurchase programme.
Commercial performance
Dupixent (dupilumab), commercialised globally by Sanofi, generated $4.9 billion in net sales during the quarter, up 33% year-on-year. Regeneron's share of profits from the Sanofi collaboration reached $1.45 billion, compared with $1.02 billion in Q1 2025. The drug continues to expand its label: in Q1 the FDA and European Commission approved it for chronic spontaneous urticaria (CSU) in children aged 2 to 11, while the FDA separately approved it as the first medicine for allergic fungal rhinosinusitis (AFRS).
The EYLEA franchise told a more mixed story. EYLEA HD (aflibercept 8 mg) posted US net sales of $468 million, up 52%, after the FDA extended its maximum dosing interval to 20 weeks — the widest of any approved injectable anti-VEGF. However, legacy EYLEA sales fell 36% to $473 million as patients migrate to the higher-dose formulation and biosimilar pressure mounts. Combined US EYLEA HD and EYLEA sales declined 10% to $941 million. A temporary interruption to bulk manufacturing at the company's Limerick, Ireland facility also weighed on GAAP gross margin, which fell to 76% from 81%; the company expects production to normalise by end of Q2. Cancer immunotherapy Libtayo (cemiplimab) was a bright spot, with global sales up 54% to $438 million.
Pipeline and regulatory milestones
The most novel approval in the quarter was Otarmeni (lunsotogene parvec), an adeno-associated virus gene therapy for severe-to-profound hearing loss caused by variants in the OTOF gene. The FDA granted accelerated approval, marking it as the first in vivo gene therapy for genetic hearing loss. Regeneron said it will make Otarmeni available free of charge in the United States, a pricing decision that will be watched closely given the broader policy context around gene therapy reimbursement.
On the pipeline front, the company said it remains on track to report Phase 3 results for fianlimab (an anti-LAG-3 antibody) in combination with cemiplimab versus pembrolizumab in first-line metastatic melanoma during Q2 2026 — a readout that will draw significant attention given the competitive dynamics of the checkpoint inhibitor market. Less encouragingly, Phase 2 data for the same combination in first-line advanced non-small cell lung cancer did not support Phase 3 advancement.
Regeneron also disclosed an agreement with the US government under which it will price certain products at or below Most-Favoured-Nation benchmarks, in exchange for relief from future pricing mandates and three years of tariff protection — a deal chief executive Leonard Schleifer described as promoting "more balanced pricing with other wealthy nations."
The broader competitive landscape for Regeneron's core franchises remains demanding. Dupixent faces emerging IL-13 and IL-33 targeting rivals in atopic dermatitis, while the EYLEA franchise contends with a growing field of approved and pipeline anti-VEGF agents, including port delivery systems and oral formulations in development at several competitors. The gene therapy space for monogenic conditions — newly entered by Regeneron via Otarmeni — is maturing rapidly, with pricing and access models still evolving across the sector. How Regeneron's free-access pledge for Otarmeni influences payer expectations for future gene therapies will be a question worth tracking.