Regeneron Pharmaceuticals, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 30 October 2026: press release. Guidance figures: 7 raised, 2 lowered, 2 kept. The quarter’s numbers.

Read the filing

Key takeaways

• Revenue and EPS both grew: Total revenues were $5,116 million, up 36% from $3,754 million. GAAP diluted EPS was $18.45, up 35%. Non-GAAP diluted EPS was $20.07, up 70%. Source
• Sanofi profit share drove growth: Sanofi collaboration revenue was $2,724 million, up 68%. The Company's share of antibody profits was $2.575 billion, against $1.456 billion, driven by higher Dupixent profits. Source
• Dupixent sales up 35%: Dupixent global net sales, recorded by Sanofi, were $6.5 billion, up 35%. U.S. sales were $5,064.1 million and rest-of-world sales were $1,476.4 million. Source
• EYLEA HD sales rose 62%: EYLEA HD U.S. net sales were $699 million, up 62%, on higher volumes from increased demand, partly offset by a lower net selling price. Source
• Pasatru approved for FOP: FDA approved Pasatru in August 2026 for FOP. An EU application is under review. Positive 84-week Phase 3 results were presented at the ASBMR meeting. Source
• Sanofi antibody alliance expanded: Regeneron received a $1.0 billion up-front payment and is entitled to up to $7.0 billion more in milestones under the amended Sanofi antibody collaboration. Source

“This was an outstanding quarter for Regeneron, with Dupixent, EYLEA HD, and Libtayo each achieving record net sales,”

Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron

Guidance

What changed from last quarter

• Guidance raised: Full-year GAAP and non-GAAP R&D ranges were raised by $100 million at each end. Source
• Guidance lowered: Full-year GAAP and non-GAAP SG&A ranges were lowered by $100 million at each end. Source
• Guidance raised: Full-year GAAP and non-GAAP gross margin on net product sales ranges were raised to approximately 80% and 86%. Source
• Guidance raised: Capital expenditure low end was raised to $1.050 billion; GAAP and non-GAAP tax rate guidance moved up to approximately 14% and 15%. Source
• Guidance kept: Full-year GAAP and non-GAAP COCM guidance was shown as unchanged. Source
• New: Regeneron and Sanofi amended their antibody collaboration in October 2026, adding next-generation, long-acting antibodies to the alliance. Source
• New: Regeneron agreed with BARDA to supply additional Inmazeb for U.S. Ebola preparedness, with doses delivered from 2027 through 2031. Source
• New: FDA approved Pasatru in August 2026 for reducing new heterotopic ossification lesions and flare-ups in adults with FOP. Source
• New: Japan approved Libtayo as an adjuvant and metastatic or locally advanced treatment for cutaneous squamous cell carcinoma in August 2026. Source
• New: The FDA accepted for review the resubmitted BLA for Ordspono in relapsed or refractory DLBCL. Source
• New: A single-arm, potentially registrational trial of ubamatamab in low-grade serous ovarian cancer began enrolling. Source
• New: Two Phase 3 studies were started: cenvacibart and amrecibart for venous thromboembolism in PICC patients, and REGN1908-1909 for cat allergy. Source
• Ended: The Sanofi Development Balance was fully repaid at the end of the second quarter, so it no longer reduces Sanofi collaboration revenue from the third quarter. Source

Results and growth drivers

• Revenue and EPS both grew: Total revenues were $5,116 million, up 36% from $3,754 million. GAAP diluted EPS was $18.45, up 35%. Non-GAAP diluted EPS was $20.07, up 70%. Source
• Sanofi profit share drove growth: Sanofi collaboration revenue was $2,724 million, up 68%. The Company's share of antibody profits was $2.575 billion, against $1.456 billion, driven by higher Dupixent profits. Source
• Operating income nearly doubled: Income from operations was $2,048.2 million, against $1,026.8 million a year earlier. GAAP net income was $1,948.7 million, against $1,460.0 million. Source
• Nine-month revenue and EPS grew: For the nine months ended September 30, 2026, total revenues were $13,011.9 million, against $10,458.6 million, and diluted EPS was $37.37, against $33.61. Source

Products and customers

• Dupixent sales up 35%: Dupixent global net sales, recorded by Sanofi, were $6.5 billion, up 35%. U.S. sales were $5,064.1 million and rest-of-world sales were $1,476.4 million. Source
• EYLEA HD sales rose 62%: EYLEA HD U.S. net sales were $699 million, up 62%, on higher volumes from increased demand, partly offset by a lower net selling price. Source
• EYLEA U.S. sales fell 41%: EYLEA U.S. net sales were $400 million, down 41%, as volumes fell and patients continued to transition to EYLEA HD. Source
• Libtayo U.S. sales rose on demand: Libtayo global net sales were $550 million, up 51%. U.S. sales were $396 million, up 81%, and rest-of-world sales were $154 million, up 5%. Source
• Other products mixed: Kevzara sales recorded by Sanofi were $255.6 million, up 66%. Praluent U.S. sales were $81 million, up 21%, and Lynozyfic global sales were $19 million. Source

“We are pleased with our third quarter financial results, which marked our third consecutive quarter of double-digit growth in both revenue and non-GAAP EPS,”

Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron

Costs, margins and tax

• R&D spend rose 22%: GAAP R&D was $1,795 million, up 22%; non-GAAP R&D was $1,654 million, up 23%. The increase was driven by pipeline advancement and manufacturing for product candidates. Source
• SG&A rose 3% on GAAP basis: GAAP SG&A was $678 million, up 3%. Non-GAAP SG&A was $588 million, up 9%. Source
• Gross margin held at 82%: GAAP gross margin on net product sales was 82% in the quarter, the same as a year earlier. For the nine months it was 79%, against 82%, reflecting manufacturing interruption costs. Source
• Manufacturing interruption costs booked: Temporary manufacturing interruption-related costs were $161.3 million in cost of goods sold and $14.8 million in COCM for the nine months. None were recorded in the quarter. Source
• Tax rate lower on GAAP basis: GAAP effective tax rate was 14.7%, against 17.2% a year earlier. Non-GAAP rate was 15.0%, against 13.1%. The prior-year GAAP rate included a $45 million charge from enactment of OBBBA. Source
• Other income fell on securities gains: GAAP other income was $235.9 million, against $736.5 million, mainly from lower net gains on marketable and other securities of $60.3 million, against $577.7 million. Source

Pipeline and regulatory milestones

• Pasatru approved for FOP: FDA approved Pasatru in August 2026 for FOP. An EU application is under review. Positive 84-week Phase 3 results were presented at the ASBMR meeting. Source
• Libtayo approvals and dosing opinion: Japan approved Libtayo for adjuvant CSCC in August 2026. The CHMP gave a positive opinion in October for six-weekly dosing after 12 weeks. Longer-term ESMO data showed increasing overall survival benefit. Source
• Ubamatamab shows ovarian responses: Ubamatamab showed a high rate of durable responses in an early study in low-grade serous ovarian cancer. A confirmatory Phase 3 trial is planned after a single-arm trial enrolls. Source
• RNAi cut liver fat about 70%: Interim Phase 1/2 results for the CIDEB RNAi therapy in MASLD showed liver fat reduced about 70% from baseline at 12 weeks, with a single dose generally well tolerated. Source
• Trevogrumab COURAGE data presented: New Phase 2 COURAGE results for trevogrumab, a myostatin antibody, were presented at EASD. The trial tested prevention of lean mass and muscle loss during GLP-1 induced weight loss. Source
• Two more Phase 3 starts: A three-arm Phase 3 started for cenvacibart and amrecibart to prevent venous thromboembolism in PICC patients. A second Phase 3 started for REGN1908-1909 in cat allergy. Source

“Our pipeline of about 50 product candidates is rapidly advancing.”

Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron

Collaborations and new agreements

• Sanofi antibody alliance expanded: Regeneron received a $1.0 billion up-front payment and is entitled to up to $7.0 billion more in milestones under the amended Sanofi antibody collaboration. Source
• Costs shared on new Sanofi programs: The companies will share development and commercialization costs equally for the new programs. Any future profits will be shared equally on a global basis if commercialized. Source
• Bayer collaboration revenue declined: Bayer collaboration revenue was $266.8 million, against $344.8 million. Regeneron's share of EYLEA profits outside the United States was $211.5 million in the quarter. Source

Capital, cash and shareholder returns

• Buybacks of $2.3 billion: The Company repurchased $2.3 billion of common stock in the nine months ended September 30, 2026. $2.2 billion remained available under share repurchase programs at quarter end. Source
• Cash dividend of $0.94 declared: In October 2026 the Company declared a cash dividend of $0.94 per share, payable December 3, 2026 to holders of record on November 20, 2026. Source
• Nine-month free cash flow lower: Free cash flow was $2,904.3 million for the nine months, against $3,158.5 million, after operating cash flow of $3,675.3 million and capital expenditures of $771.0 million. Source
• Receivables and deferred revenue rose: Accounts receivable were $7,578.6 million at September 30, 2026, up from $5,741.1 million at December 31, 2025. Deferred revenue rose to $970.0 million from $761.7 million. Source
• Cash and securities roughly unchanged: Cash and marketable securities were $18,858.5 million at September 30, 2026, against $18,865.8 million at December 31, 2025. Source

Coming up, as management said on 30 October 2026

• Cemdisiran FDA decision next month: Management expects an FDA decision on cemdisiran in generalized myasthenia gravis in November 2026. Source
• Ordspono FDA action date: The FDA target action date for the Ordspono BLA resubmission is February 2027. Source
• Libtayo FDA action date: A supplemental BLA for Libtayo is under FDA review with a target action date in March 2027. Source
• EC decision on Libtayo dosing: The European Commission is expected to make a final decision on the alternative Libtayo dosing schedule in the coming months. Source
• Liver data at AASLD: Interim CIDEB RNAi results are planned for presentation at the AASLD meeting in November 2026. Source
• MASH Phase 3 start planned: A Phase 3 study in MASH/MASLD is planned to start in the fourth quarter of 2026. Source
• POTS data at AAS: Phase 2 baloncibart results in POTS are planned for the AAS meeting in November 2026. Source
• POTS Phase 3 start planned: A Phase 3 study in POTS is planned for the first half of 2027, pending regulatory feedback. Source
• Sanofi up-front recognized in Q4: The $1.0 billion Sanofi up-front payment is to be recognized as collaboration revenue in the fourth quarter of 2026. Source

Figures management reported

Risks management discussed

• Demand: Management cited continued competitive pressures as the cause of lower EYLEA U.S. sales volumes. Source
• Operational: Temporary manufacturing interruption-related costs were recorded in the nine months, in cost of goods sold and COCM. Source

Earlier plans management reported on

• Not stated: Full-year 2026 guidance ranges were updated in this release from the prior ranges shown. Source

Other quarters

• Q2 FY2026 earnings call
• Q1 FY2026 earnings call
• Q4 FY2025 earnings call
• Q3 FY2025 results

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.