Regeneron Pharmaceuticals, Inc.
REGN · NASDAQ-GS
Next quarter
Expected to report Jan 29, 2027 — estimated from last year’s reporting date.
Consensus is $17.58 EPS for Dec 2026 across 6 estimates, ranging $12.83 to $23.76.
REGN Sep 2026
- 33.94%
- $13.76
- $18.43
- —
- $5.12B
Reported results
- $5.12B
- $2.05B
- 40.04%
- $1.95B
- $18.45
Highlights
- Quarterly results: Revenue rose 36% year over year to $5.12 billion, while GAAP diluted EPS of $18.45 was roughly 34% above $13.76 consensus; non-GAAP EPS increased 70% to $20.07.
- Sanofi collaboration: Revenue from the Sanofi alliance increased 68% to $2.72 billion, including $2.57 billion of Regeneron’s share of antibody profits, up 77%; the development balance was fully repaid in Q2, lifting the share recorded in Q3.
- Dupixent: Global sales reported by Sanofi grew 35% to a record $6.54 billion; U.S. sales reached $5.06 billion, up 40%, on broad demand and favorable gross-to-net adjustments.
- EYLEA transition: U.S. EYLEA HD sales rose 62% to $699 million, but legacy EYLEA fell 41% to $400 million; combined U.S. sales were $1.10 billion, down 1%.
- Libtayo: Global sales rose 51% to a record $550 million, including U.S. sales of $396 million, up 81%; Pasatru was also FDA-approved for FOP in August.
- Sanofi alliance expansion: The companies added four Regeneron-invented, long-acting immunology antibodies; Regeneron received $1.0 billion up front, expected to be recorded in Q4, and may earn up to $7.0 billion in milestones.
- Pipeline and spending: Early CIDEB data showed an average liver-fat reduction of about 70% at 12 weeks after one dose; Regeneron plans to start a Phase 3 MASH/MASLD study in Q4 and expects 2027 R&D expense to rise by a mid-teens percentage.
- Guidance and capital: 2026 guidance raised product-sales gross-margin expectations to approximately 80% GAAP and 86% non-GAAP; the company repurchased $2.3 billion of shares in the first nine months.
Analysis
Regeneron reported a sharp step-up in Q3: revenue of $5.12 billion increased 36% from a year earlier and 19% sequentially, while GAAP diluted EPS of $18.45 was roughly 34% above the $13.76 consensus estimate. EPS was up from $13.62 in Q3 2025 and $12.23 in Q2 2026. Non-GAAP EPS rose 70% year over year to $20.07. The main driver was Sanofi collaboration revenue, which reached $2.72 billion as Dupixent sales grew and the fully repaid development balance no longer reduced Regeneron’s recorded share of profits. The quarter also showed continuing strength in Libtayo and EYLEA HD, though that was partly offset by the decline in legacy EYLEA sales.
Dupixent global sales reached $6.54 billion, up 35%, while Libtayo grew 51% to $550 million. In ophthalmology, EYLEA HD increased 62% to $699 million, but total U.S. EYLEA HD and EYLEA sales slipped 1% to $1.10 billion as patients continued shifting from the older product amid competition. Beyond the current portfolio, Regeneron expanded its Sanofi alliance around four long-acting antibodies, securing $1.0 billion up front for Q4 recognition and up to $7.0 billion in potential milestones. The pipeline also delivered striking early CIDEB results, with about 70% average liver-fat reduction at 12 weeks, while higher R&D investment is planned to advance late-stage programs.
Earnings and revenue mix
Revenue growth translated into stronger operating performance: operating income was $2.05 billion, versus $1.03 billion a year ago and $1.29 billion in Q2. Revenue was $5.12 billion compared with $3.75 billion in Q3 2025 and $4.29 billion in Q2 2026. GAAP EPS growth was more modest than non-GAAP growth partly because other income declined to $246 million from $756 million a year ago, primarily reflecting lower net gains on securities. GAAP R&D expense increased 22% to $1.79 billion as the pipeline and clinical manufacturing activity advanced.
Sanofi collaboration
Sanofi collaboration revenue rose to $2.72 billion from $1.62 billion. Regeneron’s share of profits from antibody commercialization increased to $2.57 billion from $1.46 billion, principally on higher Dupixent profits and the end of the development-balance repayment deduction. The balance was fully repaid at the end of Q2, so Q3 was the first quarter in which Regeneron recorded its full share of collaboration profits. Manufacturing reimbursements were $149 million, down from $162 million.
- Dupixent demand: Sanofi-reported global sales were $6.54 billion, up 35%; U.S. sales were $5.06 billion, up 40%, with management citing demand across indications as well as favorable gross-to-net adjustments.
- Other collaboration revenue: Bayer collaboration revenue fell 23% to $267 million as Regeneron’s share of EYLEA profits outside the U.S. declined; other revenue rose 57% to $310 million, including an approximately $60 million cumulative Ilaris royalty catch-up that will not recur in Q4.
Commercial portfolio
- EYLEA HD: U.S. net sales rose 62% to $699 million. Management reported physician unit demand up 20% sequentially, supported by label enhancements and broader use; it expects about 10% sequential sales growth in Q4, partly offset by pricing pressure.
- EYLEA: U.S. sales fell 41% to $400 million as competition and the transition to EYLEA HD reduced volume. Management expects a low- to mid-teens sequential demand decline in Q4. Combined U.S. sales for the two products were $1.10 billion, down 1% year over year.
- Libtayo: Global sales rose 51% to $550 million, including U.S. sales of $396 million, up 81%. Growth reflects demand in skin cancer and lung cancer; the FDA is reviewing a supplemental application for six-week dosing, with a target decision in March 2027.
- Other launches: Pasatru received FDA approval in August to reduce new bone lesions and flare-ups in adults with FOP. Lynozyfic recorded $19 million in global sales, while management expects growth to remain modest until the product advances into earlier lines of multiple myeloma.
Expanded Sanofi alliance
The October amendment adds four Regeneron-invented long-acting antibodies targeting IL-13, IL-4, IL-4 receptor alpha, and IL-4/IL-13. Regeneron received a $1.0 billion up-front payment, which it expects to recognize as collaboration revenue in Q4 2026, and is eligible for up to $7.0 billion in additional development, regulatory, and sales-based milestones. The companies will share development and commercialization costs equally and, if products reach market, share global profits equally. The lead IL-13 program is in Phase 1; the other three are expected to enter clinical studies in 2027.
Pipeline and outlook
- CIDEB: Early Phase 1/2 results showed a roughly 70% average reduction in liver fat from baseline at 12 weeks after one dose, with the effect sustained through 24 weeks of follow-up. The company plans to initiate a Phase 3 MASH/MASLD study in Q4 2026.
- Near-term milestones: An FDA decision on cemdisiran for generalized myasthenia gravis is expected in November 2026. Regeneron also plans to report Phase 2 POTS results in Q4 and is enrolling a potentially registrational study of ubamatamab in low-grade serous ovarian cancer, with a confirmatory Phase 3 planned for 2027.
- 2026 guidance: The company raised expected gross margin on product sales to approximately 80% GAAP and 86% non-GAAP, increased R&D expense ranges by $100 million at each end, and lowered SG&A expense ranges. The $1.0 billion Sanofi payment is expected to be recognized in Q4.
- Investment and capital: Management expects 2027 R&D expense to increase by a mid-teens percentage versus 2026, reflecting advanced programs in myeloma, anticoagulation, and obesity. Regeneron repurchased $2.3 billion of shares in the first nine months and had $2.2 billion remaining under its repurchase authorization.
