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Third quarter 2026 revenues increased 36% to$5.1 billionversus third quarter 2025
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Dupixent® global net sales (recorded by Sanofi) increased 35% to$6.5 billion
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EYLEA HD® U.S. net sales increased 62% to $699 million
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Libtayo® global net sales increased 51% to $550 million
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GAAP EPS increased 35% to$18.45; non-GAAP EPS(a) increased 70% to$20.07
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Expanded collaboration with Sanofi, adding multiple next-generation, long-acting immunology antibodies;$1.0 billionup-front to be recognized as collaboration revenue in fourth quarter 2026 with potential to receive up to an additional$7.0 billionin future milestones
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Pasatru™ (garetosmab) approved by FDA for fibrodysplasia ossificans progressiva (FOP)
TARRYTOWN, N.Y.,Oct. 30, 2026(GLOBE NEWSWIRE) --Regeneron Pharmaceuticals, Inc.(Nasdaq: REGN) today announced financial results for the third quarter of 2026 and provided a business update.
"This was an outstanding quarter forRegeneron, with Dupixent, EYLEA HD, and Libtayo each achieving record net sales," saidLeonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer ofRegeneron. "Our pipeline of about 50 product candidates is rapidly advancing. We expect an FDA decision for cemdisiran in generalized myasthenia gravis next month; our Phase 3 programs in multiple myeloma, lymphoma, anticoagulation, and obesity continue to advance; and we have generated encouraging early data in MASH, POTS, and ovarian cancer. Finally, we expanded our alliance with Sanofi to include fourRegeneron-invented, next-generation, long-acting antibodies designed to build on the success of Dupixent."
Financial Highlights
| ($ in millions, except per share data) | Q3 2026 |
Q3 2025 |
% Change | ||||||||
| Total revenues | $ | 5,116 | $ | 3,754 | 36% | ||||||
| GAAP net income | $ | 1,949 | $ | 1,460 | 33% | ||||||
| GAAP net income per share - diluted | $ | 18.45 | $ | 13.62 | 35% | ||||||
| Non-GAAP net income(a) | $ | 2,150 | $ | 1,287 | 67% | ||||||
| Non-GAAP net income per share - diluted(a) | $ | 20.07 | $ | 11.83 | 70% | ||||||
"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," saidChristopher Fenimore, Executive Vice President, Finance and Chief Financial Officer ofRegeneron. "Strong commercial execution across our portfolio, together with the anticipated step-up in Sanofi collaboration revenue in the first full quarter following repayment of the Development Balance, drove a 36% increase in total revenues and a 70% increase in non-GAAP EPS, positioning us to deliver one of our strongest years ever."
Business Highlights
Key Pipeline Progress
Regeneronhas approximately 50 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:
Libtayo (cemiplimab)
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In August 2026, the Ministry of Health, Labour and Welfare (MHLW) in Japan approved Libtayo as an adjuvant treatment for cutaneous squamous cell carcinoma (CSCC) and for the treatment of metastatic or locally advanced CSCC. These indications are already approved in the United States and European Union (EU).
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In October 2026, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of an alternative dosing schedule for Libtayo across all approved indications. The positive opinion supports reducing Libtayo dosing frequency from every three weeks to every six weeks after the first 12 weeks of treatment. The European Commission (EC) is expected to make a final decision in the coming months. There is also a supplemental Biologics License Application (sBLA) under review by the U.S. Food and Drug Administration (FDA), which has a target action date in March 2027.
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In October 2026, the Company announced longer-term data which showed increasing and clinically meaningful overall survival benefit for Libtayo as an adjuvant treatment for patients with CSCC. The results were presented at the European Society for Medical Oncology (ESMO)2026 Meeting.
Other Oncology Programs
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The FDA accepted for review the resubmission of the BLA for Ordspono™ (odronextamab) in relapsed or refractory diffuse large B-cell lymphoma (DLBCL), which has a target action date inFebruary 2027.
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The Company announced that ubamatamab (MUC16 and CD3 bispecific antibody) showed a high rate of durable responses in an initial study in patients with advanced low-grade serous ovarian cancer (LGSOC). The data are from an ongoing Phase 1/2 trial and were presented at the International Gynecologic Cancer Society (IGCS) 2026 Annual Global Meeting. Based on these preliminary trial results, the Company has been enrolling a single-arm, potentially registrational LGSOC trial and is planning to initiate a confirmatory Phase 3 trial in this setting.
Pasatru (garetosmab)
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In August 2026, the FDA approved Pasatru to reduce formation of new heterotopic ossification lesions and clinician-assessed flare-ups in adults with FOP. A regulatory application is also under review in the EU.
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The Company announced positive 84-week results from the Phase 3 trial for Pasatru in adults with FOP. These longer-term findings demonstrated sustained efficacy in halting new, rogue bone growth and in significantly reducing disease flare-ups, and were presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting.
Other Programs
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A three-arm, placebo-controlled Phase 3 study was initiated to evaluate cenvacibart (an antibody to Factor XI (catalytic domain)), and amrecibart (an antibody to Factor XI (A2 domain)), individually, for the prevention of venous thromboembolism in patients with a peripherally inserted central catheter (PICC).
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The Company has an ongoing Phase 1/2 study for its RNAi therapy targeting CIDEB. Interim results from this randomized, placebo-controlled, first-in-human trial in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) showed that a single dose was generally well tolerated and reduced liver fat by approximately 70% on average from baseline at 12 weeks, with effects sustained through 24 weeks of follow-up. The Company plans to present interim results at the
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American Association for the Study of Liver Diseases (AASLD) Meeting in November 2026 and to initiate a Phase 3 study in metabolic dysfunction-associated steatohepatitis (MASH)/MASLD in the fourth quarter of 2026.
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The Company plans to report results from the Phase 2 study for baloncibart (NPR1 antagonist antibody) in postural orthostatic tachycardia syndrome (POTS) at the American Autonomic Society (AAS) Meeting in November 2026. Additionally, the Company plans to initiate a Phase 3 study in POTS in the first half of 2027, pending regulatory feedback.
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The Company announced new results from the Phase 2 COURAGE trial evaluating trevogrumab (myostatin antibody) for its potential to prevent lean mass and muscle loss during GLP-1 receptor agonist-induced weight loss in people living with obesity. The results of the trial were presented at the European Association for the Study of Diabetes (EASD) Annual Meeting.
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A second Phase 3 study was initiated for REGN1908-1909, an investigational treatment for cat allergy.
Corporate Updates
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In October 2026, the Company and Sanofi amended their antibody collaboration, adding multiple next-generation, long-acting Regeneron-invented antibodies to the alliance. Under the terms of the agreement, the Company received an up-front payment of $1.0 billion, and is entitled to receive up to an additional $7.0 billion in the aggregate upon the achievement of certain development, regulatory, and sales-based milestones. The companies will equally share development and commercialization costs for the new programs, and, if commercialized, share any future profits equally on a global basis.
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In October 2026, the Company announced an agreement with the Biomedical Advanced Research and Development Authority(BARDA) to provide additional supply of Inmazeb® for U.S. preparedness against Ebola disease. Under the terms of the agreement, the Company expects to deliver a pre-specified number of treatment doses of Inmazeb each year to theU.S. government beginning in 2027 through 2031.
Third Quarter 2026 Financial Results
Revenues
| ($ in millions) | Q3 2026 |
Q3 2025 |
% Change | ||||||||
| Net product sales: | |||||||||||
| EYLEA HD - U.S. | $ | 699 | $ | 431 | 62% | ||||||
| EYLEA® - U.S. | 400 | 681 | (41% | ) | |||||||
| Total EYLEA HD and EYLEA - U.S. | 1,099 | 1,112 | (1% | ) | |||||||
| Libtayo - U.S. | 396 | 219 | 81% | ||||||||
| Libtayo - ROW* | 154 | 146 | 5% | ||||||||
| Total Libtayo - Global | 550 | 365 | 51% | ||||||||
| Praluent® - U.S. | 81 | 67 | 21% | ||||||||
| Evkeeza® - U.S. | 55 | 43 | 28% | ||||||||
| Lynozyfic® - Global | 19 | 1 | ** | ||||||||
| Other products - Global | 1 | — | ** | ||||||||
| Total net product sales | 1,805 | 1,588 | 14% | ||||||||
| Collaboration revenue: | |||||||||||
| Sanofi | 2,724 | 1,617 | 68% | ||||||||
| Bayer | 267 | 345 | (23% | ) | |||||||
| Other | 10 | 6 | 67% | ||||||||
| Other revenue | 310 | 198 | 57% | ||||||||
| Total revenues | $ | 5,116 | $ | 3,754 | 36% | ||||||
| * Rest of world (ROW) | |||||||||||
| ** Percentage not meaningful or greater than 100% | |||||||||||
EYLEA HDU.S. net product sales increased in the third quarter of 2026, compared to the third quarter of 2025, primarily due to higher sales volumes driven by increased demand, partly offset by a lower net selling price.
EYLEAU.S. net product sales decreased in the third quarter of 2026, compared to the third quarter of 2025, primarily due to lower sales volumes as a result of continued competitive pressures and the continued transition of patients to EYLEA HD.
LibtayoU.S. net product sales increased in the third quarter of 2026, compared to the third quarter of 2025, primarily due to higher sales volumes driven by increased demand.
Sanofi collaboration revenue increased in the third quarter of 2026, compared to the third quarter of 2025, due to an increase in the Company's share of profits from the commercialization of antibodies, which were$2.575 billionand$1.456 billionin the third quarter of 2026 and 2025, respectively. The increase in the Company's share of profits from the commercialization of antibodies was driven by higher profits primarily associated with an increase in Dupixent sales. In addition, the Sanofi Development Balance was fully repaid as of the end of the second quarter of 2026 and no longer reduced Sanofi collaboration revenue beginning in the third quarter of 2026.
Refer to Table 4 for a summary of collaboration revenue.
Operating Expenses
| GAAP | % Change |
Non-GAAP(a) | % Change |
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| ($ in millions) | Q3 2026 | Q3 2025 | Q3 2026 | Q3 2025 | ||||||||||||||||||
| Research and development (R&D) | $ | 1,795 | $ | 1,475 | 22% | $ | 1,654 | $ | 1,350 | 23% | ||||||||||||
| Acquired in-process research and development (IPR&D) | $ | 22 | $ | 83 | (73% | ) | * | * | * | |||||||||||||
| Selling, general, and administrative (SG&A) | $ | 678 | $ | 658 | 3% | $ | 588 | $ | 541 | 9% | ||||||||||||
| Cost of goods sold (COGS) | $ | 322 | $ | 281 | 15% | $ | 246 | $ | 227 | 8% | ||||||||||||
| Gross margin on net product sales(b) | 82% | 82% | 86% | 86% | ||||||||||||||||||
| Cost of collaboration and contract manufacturing (COCM)(c) | $ | 252 | $ | 241 | 5% | * | * | * | ||||||||||||||
| Other operating (income) expense, net | $ | — | $ | (10 | ) | (100% | ) | * | * | * | ||||||||||||
| * GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded | ||||||||||||||||||||||
GAAP and non-GAAP R&D expenses increased in the third quarter of 2026, compared to the third quarter of 2025, driven by the advancement of the Company's clinical pipeline and increased manufacturing activity associated with the Company's product candidates.
Other Financial Information
GAAP other income (expense), net decreased in the third quarter of 2026, compared to the third quarter of 2025, primarily due to lower net gains on marketable and other securities.
In the third quarter of 2026, the Company's GAAP effective tax rate (ETR) was 14.7%, compared to 17.2% in the third quarter of 2025. The GAAP ETR for the third quarter of 2025 was negatively impacted by the enactment of the "One Big Beautiful Bill Act" or "OBBBA," including a$45 millioncharge related to the re-measurement of the Company'sU.S. net deferred tax assets. In the third quarter of 2026, the non-GAAP ETR was 15.0%, compared to 13.1% in the third quarter of 2025.
A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release.
Capital Allocation
During the nine months endedSeptember 30, 2026, the Company repurchased$2.3 billionof its common stock. As ofSeptember 30, 2026,$2.2 billionremained available for share repurchases under the Company's share repurchase programs.
InOctober 2026, the Company declared a cash dividend of$0.94per share on the Company's common stock and Class A stock, payable onDecember 3, 2026to shareholders of record as ofNovember 20, 2026.
2026 Financial Guidance*
| 2026 Guidance | ||||
| Prior | Updated | |||
| GAAP R&D | $6.500–$6.635 billion | $6.600–$6.735 billion | ||
| Non-GAAP R&D(a) | $5.950–$6.050 billion | $6.050–$6.150 billion | ||
| GAAP SG&A | $2.830–$2.960 billion | $2.730–$2.860 billion | ||
| Non-GAAP SG&A(a) | $2.500–$2.600 billion | $2.400–$2.500 billion | ||
| GAAP gross margin on net product sales | 78%–79% | Approximately 80% | ||
| Non-GAAP gross margin on net product sales(a) | 84%–85% | Approximately 86% | ||
| GAAP COCM | $985 million–$1.035 billion | Unchanged | ||
| Non-GAAP COCM(a) | $970 million–$1.020 billion | Unchanged | ||
| Capital expenditures | $1.030–$1.100 billion | $1.050–$1.100 billion | ||
| GAAP effective tax rate | 13%–14% | Approximately 14% | ||
| Non-GAAP effective tax rate(a) | 14%–15% | Approximately 15% | ||
| * The Company's 2026 financial guidance does not assume the completion of any business development transactions not completed as of the date of this press release | ||||
The Company's full year 2026 financial guidance consists of the following components:
| 2026 Guidance | ||||
| Prior | Updated | |||
| GAAP R&D | $6.500–$6.635 billion | $6.600–$6.735 billion | ||
| Non-GAAP R&D(a) | $5.950–$6.050 billion | $6.050–$6.150 billion | ||
| GAAP SG&A | $2.830–$2.960 billion | $2.730–$2.860 billion | ||
| Non-GAAP SG&A(a) | $2.500–$2.600 billion | $2.400–$2.500 billion | ||
| GAAP gross margin on net product sales | 78%–79% | Approximately 80% | ||
| Non-GAAP gross margin on net product sales(a) | 84%–85% | Approximately 86% | ||
| GAAP COCM | $985 million–$1.035 billion | Unchanged | ||
| Non-GAAP COCM(a) | $970 million–$1.020 billion | Unchanged | ||
| Capital expenditures | $1.030–$1.100 billion | $1.050–$1.100 billion | ||
| GAAP effective tax rate | 13%–14% | Approximately 14% | ||
| Non-GAAP effective tax rate(a) | 14%–15% | Approximately 15% | ||
| * The Company's 2026 financial guidance does not assume the completion of any business development transactions not completed as of the date of this press release | ||||
A reconciliation of full year 2026 GAAP to non-GAAP financial guidance is included below:
| Projected Range | ||||||||
| ($ in millions) | Low | High | ||||||
| GAAP R&D | $ | 6,600 | $ | 6,735 | ||||
| Stock-based compensation expense | (550 | ) | (580 | ) | ||||
| Other | — | (5 | ) | |||||
| Non-GAAP R&D(a) | $ | 6,050 | $ | 6,150 | ||||
| GAAP SG&A | $ | 2,730 | $ | 2,860 | ||||
| Stock-based compensation expense | (325 | ) | (350 | ) | ||||
| Other* | (5 | ) | (10 | ) | ||||
| Non-GAAP SG&A(a) | $ | 2,400 | $ | 2,500 | ||||
| GAAP gross margin on net product sales | 80% | 80% | ||||||
| Stock-based compensation expense | 1% | 1% | ||||||
| Other** | 5% | 5% | ||||||
| Non-GAAP gross margin on net product sales(a) | 86% | 86% | ||||||
| GAAP COCM | $ | 985 | $ | 1,035 | ||||
| Temporary manufacturing interruption-related costs | (15 | ) | (15 | ) | ||||
| Non-GAAP COCM(a) | $ | 970 | $ | 1,020 | ||||
| GAAP ETR | 14% | 14% | ||||||
| Income tax effect of GAAP to non-GAAP reconciling items | 1% | 1% | ||||||
| Income tax expense: Shortfall from stock-based compensation | (<1% | ) | (<1% | ) | ||||
| Non-GAAP ETR(a) | 15% | 15% | ||||||
| * Includes litigation settlements and other costs | ||||||||
| ** Includes intangible asset amortization and temporary manufacturing interruption-related costs | ||||||||
| (a) | This press release uses non-GAAP R&D, non-GAAP SG&A, non-GAAP COGS, non-GAAP gross margin on net product sales, non-GAAP COCM, non-GAAP other income (expense), net, non-GAAP ETR, non-GAAP net income, non-GAAP net income per share, and free cash flow, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles (GAAP). These non-GAAP financial measures are computed by excluding certain non-cash and/or other items from the related GAAP financial measure. The Company also includes a non-GAAP adjustment for the estimated income tax effect of reconciling items. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release. The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance. For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company's control (such as the Company's stock price on the dates share-based grants are issued or changes in the fair value of the Company's investments in equity securities) or items that are not associated with normal, recurring operations (such as acquisition and integration costs). Management uses these non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. With respect to free cash flow, the Company believes that this non-GAAP measure provides a further measure of the Company's ability to generate cash flows from its operations. Additionally, the non-GAAP measures presented are intended to provide investors with an enhanced understanding of the financial performance of the Company's core business operations. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company's non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by the Company should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP. |
| (b) | Gross margin on net product sales represents gross profit expressed as a percentage of total net product sales recorded by the Company. Gross profit is calculated as net product sales less cost of goods sold. |
| (c) | Corresponding reimbursements from collaborators and others for manufacturing product is recorded within revenues. |
About Regeneron
Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, Regeneron's unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in Regeneron's laboratories. Regeneron's medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery and accelerates drug development using its proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. Regeneron is shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling Regeneron to identify innovative targets and complementary approaches to potentially treat or cure diseases.