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Earnings Score 48 Bullish

Regeneron Reports Strong Q1 Growth Amid Eylea Headwinds and New FDA Approval

May 02, 2026 15:20 UTC
REGN
Medium term

Regeneron Pharmaceuticals posted a 19% increase in first-quarter revenue, bolstered by strong sales of Dupixent and Libtayo. The company also secured FDA approval for its first gene therapy for hearing loss, Otarmeni.

  • Q1 revenue reached $3.6 billion, a 19% year-over-year increase
  • Adjusted EPS grew 15% to $9.47
  • Dupixent sales rose 36% to $1.6 billion
  • FDA approved Otarmeni gene therapy for hearing loss
  • Authorized $3 billion in new share buybacks
  • Pipeline includes 34 late-stage therapies

Regeneron Pharmaceuticals (NASDAQ: REGN) reported first-quarter revenue of $3.6 billion, exceeding analyst expectations of $3.48 billion. Despite a year-to-date decline in share price of over 11%, the company demonstrated robust top-line growth of 19% year-over-year. The results highlight a transition in the company's product portfolio. While the top-selling eye therapy Eylea saw sales drop 10% to $941 million due to competition from Roche's Vabysmo, other assets are scaling rapidly. Cancer therapy Libtayo grew 54% to $438 million, and the shared blockbuster Dupixent surged 36% to $1.6 billion. Financial performance remained strong with adjusted earnings per share (EPS) rising 15% year-over-year to $9.47. Leveraging this growth, the company authorized a new $3 billion share repurchase program, following an $803 million buyback executed in the first quarter. In a significant regulatory milestone, the FDA granted accelerated approval for Otarmeni, a gene therapy for profound hearing loss. In a strategic move to secure favorable pricing terms for its broader portfolio and avoid future government-led price negotiations, Regeneron will provide Otarmeni free of charge within the U.S. while maintaining traditional pricing internationally. Looking forward, Regeneron maintains a deep pipeline with over 50 therapies, including 34 in late-stage trials. The company is currently tracking toward phase 3 results for fianlimab in metastatic melanoma and is developing GLP-1 weight loss therapies. Currently trading at a P/E ratio of approximately 16.5, the valuation remains modest relative to historical averages and high-growth biotech peers.

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