US Exchange Filings

Regeneron Reports Strong Q3 Growth, Expands Sanofi Alliance, Wins Pasatru Approval

Regeneron reported strong third-quarter growth, with revenue up 36% and diluted earnings per share rising under both GAAP and non-GAAP measures. The company also expanded its Sanofi collaboration to cover four next-generation immunology antibodies, announced a substantial upfront collaboration payment for the fourth quarter, and said the FDA approved its drug Pasatru for a rare bone disorder.

Key details

  • Revenue and earnings rose sharply. Third-quarter revenue was $5.12 billion, up from $3.75 billion a year earlier. GAAP net income increased 33% to $1.95 billion, and diluted GAAP earnings per share rose 35% to $18.45. Non-GAAP diluted earnings per share climbed 70% to $20.07; non-GAAP net income increased 67% to $2.15 billion.

  • Several major products posted strong sales.

  • Dupixent global net sales, which are recorded by Sanofi, rose 35% to $6.5 billion.
  • U.S. net sales of EYLEA HD increased 62% to $699 million.
  • Libtayo global net sales grew 51% to $550 million.

Regeneron said Dupixent, EYLEA HD and Libtayo each reached record net sales. Dupixent’s sales are Sanofi-reported figures, not a direct measure of Regeneron’s own revenue.

  • The Sanofi alliance is expanding. The companies added four Regeneron-invented, next-generation long-acting antibodies focused on immunology. Regeneron expects to recognize $1 billion of upfront collaboration revenue in the fourth quarter of 2026 and may receive up to an additional $7 billion in future milestone payments.

  • Pasatru received FDA approval. The agency approved garetosmab, branded Pasatru, for fibrodysplasia ossificans progressiva, or FOP.

  • The pipeline update included several upcoming or ongoing programs. Regeneron said it expected an FDA decision the following month on cemdisiran for generalized myasthenia gravis. It also said Phase 3 programs in multiple myeloma, lymphoma, anticoagulation and obesity were advancing, with encouraging early data in MASH, POTS and ovarian cancer. No additional trial results or timelines for those programs were included in the provided update.

What changes for investors

The Sanofi expansion adds four antibody programs to the collaboration and is expected to contribute $1 billion in revenue recognition in the fourth quarter, with further payments dependent on future milestones. The company also reported its third consecutive quarter of double-digit growth in both revenue and non-GAAP earnings per share, attributing the quarter’s performance to commercial execution and higher Sanofi collaboration revenue.

Original Filing

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