What Regeneron Pharmaceuticals (REGN) Said on Its Q3 Earnings Call

Key Points

• Regeneron delivered strong Q3 results: Revenue rose 36% year over year to $5.1 billion, while non-GAAP diluted EPS increased 70% to $20.07, driven by Sanofi collaboration revenue and growth from DUPIXENT, EYLEA HD and LIBTAYO.
• Commercial performance was mixed but generally strong: DUPIXENT sales exceeded $6.5 billion globally, and LIBTAYO sales grew 51% at constant currency. EYLEA HD sales surged 62%, offsetting a 41% decline in legacy EYLEA sales amid biosimilar competition.
• The pipeline is advancing across several therapeutic areas: Regeneron expects near-term milestones for cemdisiran, its CIDEB-targeting MASH program and oncology candidate ubamatamab, while planning more than 15 Phase III trial starts in 2026 and higher R&D spending in 2027.

Regeneron Pharmaceuticals NASDAQ: REGN reported third-quarter 2026 revenue growth of 36% year over year to $5.1 billion, while non-GAAP diluted earnings per share rose 70% to $20.07. The company attributed the performance to increased Sanofi collaboration revenue and continued growth from DUPIXENT, EYLEA HD and LIBTAYO.

“This marks our third consecutive quarter of double-digit growth on both the top and bottom lines,” Chief Executive Officer Leonard Schleifer said during the company’s earnings call.

Commercial brands reach quarterly records

DUPIXENT, which Regeneron markets through its collaboration with Sanofi, recorded worldwide net sales of more than $6.5 billion in the quarter, up 35% at constant currency, according to Sanofi-reported figures. U.S. sales increased 40% to $5.1 billion, supported by demand across its approved indications and favorable gross-to-net adjustments.

Marion McCourt, Regeneron’s executive vice president of commercial, said more than 1.5 million patients worldwide are currently being treated with DUPIXENT. The medicine is approved across nine type 2 inflammatory diseases, including atopic dermatitis, asthma, nasal polyps, eosinophilic esophagitis, COPD and chronic spontaneous urticaria.

Regeneron’s U.S. retinal franchise, combining EYLEA HD and EYLEA, generated $1.1 billion in net sales, down 1% from a year earlier. EYLEA HD sales climbed 62% to $699 million and accounted for nearly two-thirds of the franchise’s sales. Physician unit demand for EYLEA HD increased 20% sequentially.

EYLEA U.S. net sales declined 41% to $400 million amid competition from aflibercept 2 mg biosimilars. For the fourth quarter, Regeneron expects EYLEA HD physician demand to grow by about 10% sequentially, while EYLEA demand is expected to decline by a low- to mid-teens percentage. The company continues to expect more than 50% full-year EYLEA HD sales growth versus 2025.

LIBTAYO worldwide net sales rose 51% at constant currency to $550 million, including U.S. sales of $396 million, up 81%. Schleifer said LIBTAYO is now on an annual run rate of about $2.2 billion. The company said it remains the leading immunotherapy in U.S. non-melanoma skin cancers and the second most prescribed immunotherapy in non-small cell lung cancer.

Pipeline milestones include C5, MASH and oncology programs

Regeneron expects an FDA decision in November for cemdisiran, its C5 siRNA candidate for generalized myasthenia gravis. If approved, the company said cemdisiran would be the first siRNA therapy for the condition and would offer quarterly subcutaneous dosing. McCourt said the company’s neurology commercial team is launch-ready, though she did not provide further details on launch strategy.

The company also expects pivotal results by year-end for its cemdisiran and pozelimab combination in paroxysmal nocturnal hemoglobinuria. George Yancopoulos, Regeneron’s chief scientific officer, said lead-in cohort findings from the Phase III program suggested the combination could provide strong control of intravascular hemolysis.

In metabolic disease, Regeneron plans to present initial first-in-human data for its CIDEB-targeting siRNA at The Liver Meeting in November. In 40 participants, a single dose was well tolerated and reduced liver fat by approximately 70% on average from baseline after 12 weeks, according to Yancopoulos. The effect lasted through 24 weeks of follow-up and was accompanied by improvements in liver enzymes.

The company said it is advancing the CIDEB program toward registrational studies for MASH. Yancopoulos characterized the target as genetically validated through the company’s Regeneron Genetics Center research, which linked loss-of-function CIDEB variants to reduced risk of fatty liver disease and cirrhosis.

Regeneron also plans to begin a potentially registrational study of baloncibart for postural orthostatic tachycardia syndrome, or POTS, in the first half of 2027, pending regulatory feedback. The company said Phase II results showed sustained improvements in tachycardia and orthostatic symptoms over four weeks after a single high dose.

In oncology, Regeneron reported that ubamatamab, a MUC16xCD3 bispecific antibody, showed an approximately 70% objective response rate in advanced low-grade serous ovarian cancer. The company is enrolling a potentially registrational cohort and plans to begin a confirmatory Phase III study in mid-2027.

Sanofi alliance and investment outlook

Third-quarter Sanofi collaboration revenue reached $2.7 billion, including $2.6 billion from Regeneron’s share of collaboration profits. Profit-sharing revenue increased 77% from the prior year, aided by DUPIXENT growth and completion of repayment of the Sanofi development balance in the second quarter.

Under an expanded alliance, Regeneron and Sanofi will share development and commercialization costs equally for four next-generation long-acting antibodies aimed at type 2 inflammation. Global profits from those candidates will also be shared equally. Regeneron expects to recognize a $1 billion upfront payment from Sanofi as collaboration revenue in the fourth quarter.

The company generated $2.9 billion in free cash flow during the first nine months of 2026 and ended the quarter with $16.2 billion in cash and marketable securities, net of debt. It deployed nearly $3 billion during the period across share repurchases, business development and dividends, including $2.3 billion to repurchase 3.2 million shares.

Chief Financial Officer Chris Fenimore said Regeneron expects full-year share repurchases of approximately $3 billion. Looking to 2027, the company expects research and development expense to rise by a mid-teens percentage as it advances registrational programs in myeloma, anticoagulation, obesity, POTS and MASH. Regeneron said it is on pace to initiate more than 15 Phase III trials in 2026.

About Regeneron Pharmaceuticals (NASDAQ:REGN)

Regeneron Pharmaceuticals, Inc is a biotechnology company that discovers, develops and commercializes medicines for serious medical conditions. The company uses genetic and antibody-based research technologies to develop treatments in areas including eye diseases, allergic and inflammatory conditions, cancer, cardiovascular disease, infectious diseases and rare disorders.

Its marketed products include Eylea and Eylea HD for retinal diseases, Dupixent for several inflammatory and allergic conditions, Libtayo for certain cancers, Praluent for cardiovascular disease, Kevzara for rheumatoid arthritis, and other medicines such as Inmazeb, Evkeeza, Veopoz and Arcalyst.

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