Regeneron Pharmaceuticals 8-K

PositiveEarningsGuidance

Dupixent growth lifts Sanofi collaboration revenue; expanded antibody alliance adds $1B upfront to Q4 revenue

Filed 2026-10-30 06:50 ET

Summary

Q3 2026 results with updated FY2026 guidance. Revenue rose 36% to $5.12B, driven by growth in Sanofi collaboration revenue and key medicines including Dupixent, EYLEA HD and Libtayo. Regeneron expanded its Sanofi alliance to add four next-generation, long-acting antibodies and received FDA approval for Pasatru, a treatment to reduce new bone growth and disease flare-ups in adults with fibrodysplasia ossificans progressiva.

Key Figures

Metric Q3 2026 9M 2026
Revenue $5.12B, +36% Y/Y $13.0B, +24% Y/Y
Operating income $2.05B, +99% Y/Y $3.98B, +48% Y/Y
Net income, GAAP $1.95B, +33% Y/Y $3.97B, +9% Y/Y
Net income, non-GAAP $2.15B, +67% Y/Y $4.73B, +30% Y/Y
Diluted EPS, GAAP $18.45, +35% Y/Y $37.37, +11% Y/Y
Diluted EPS, non-GAAP $20.07, +70% Y/Y $43.70, +33% Y/Y
Operating cash flow — $3.68B, -3% Y/Y
Free cash flow — $2.90B, -8% Y/Y
  • Sanofi collaboration revenue increased 68% to $2.72B, including $2.58B in Regeneron’s share of antibody profits, as Dupixent sales recorded by Sanofi grew 35% to $6.54B; the Sanofi Development Balance was fully repaid at the end of Q2. U.S. EYLEA HD sales increased 62% to $699M on higher volume, while U.S. EYLEA sales fell 41% to $400M amid competition and patient transition to EYLEA HD. Global Libtayo sales rose 51% to $550M.
  • The expanded Sanofi alliance covers four Regeneron-invented antibodies. Regeneron received $1.0B up front, to be recognized as Q4 2026 collaboration revenue, and may receive up to $7.0B in additional development, regulatory and sales milestones; the companies will share development and commercialization costs and any future global profits equally.
  • Regeneron reported approximately 50 clinical-stage product candidates. It expects an FDA decision on cemdisiran for generalized myasthenia gravis in November 2026; the Ordspono review has a February 2027 target action date and the FDA’s target date for Libtayo’s alternative dosing schedule is March 2027. Nine-month share repurchases were $2.3B, with $2.2B remaining available; average diluted shares were 106.3M vs 108.9M. The company declared a $0.94-per-share dividend, payable 12/03/2026 to holders of record 11/20/2026.

Guidance

Metric Period Guidance Prior Direction
GAAP R&D FY2026 $6.600B–$6.735B $6.500B–$6.635B Raised
Non-GAAP R&D FY2026 $6.050B–$6.150B $5.950B–$6.050B Raised
GAAP SG&A FY2026 $2.730B–$2.860B $2.830B–$2.960B Lowered
Non-GAAP SG&A FY2026 $2.400B–$2.500B $2.500B–$2.600B Lowered
GAAP gross margin on net product sales FY2026 ≈80% 78%–79% Raised
Non-GAAP gross margin on net product sales FY2026 ≈86% 84%–85% Raised
GAAP COCM FY2026 $985M–$1.035B — Reaffirmed
Non-GAAP COCM FY2026 $970M–$1.020B — Reaffirmed
Capital expenditures FY2026 $1.050B–$1.100B $1.030B–$1.100B Raised
GAAP effective tax rate FY2026 ≈14% 13%–14% —
Non-GAAP effective tax rate FY2026 ≈15% 14%–15% —

Investor Takeaways

  • Q4 2026 results will include the $1.0B Sanofi up-front payment; subsequent milestone payments depend on development, regulatory and sales achievements.
  • Watch upcoming regulatory decisions, including cemdisiran in November 2026, Ordspono in February 2027 and Libtayo’s alternative dosing schedule in March 2027.
  • Track growth in Dupixent, EYLEA HD and Libtayo against continued EYLEA declines; sustained growth in the expanding products would support the commercial trends reported this quarter.

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Model 005 · prompt v111 · 2026-10-30 14:38:51Z

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