On January 30, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the fourth quarter and full year 2025 and provided a business update.
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"Regeneron performed well in 2025, with financial strength driven by our four blockbuster medicines and future growth supported by our exciting late-stage clinical portfolio," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "In the fourth quarter, we secured label expansions and new filler solutions for EYLEA HD, further enhancing its commercial potential. Dupixent received new approvals in Japan and Europe and is currently the most widely used innovative branded antibody medicine, with over 1.4 million active patients worldwide. Libtayo also secured additional approvals and continues to be the leading immunotherapy for non-melanoma skin cancers. Our current success is underscored by decades of investment in innovative science and technology, setting us up for exciting data read-outs and potential approvals in 2026 in a broad range of diseases."
Financial Highlights
($ in millions, except per share data) Q4 2025
Q4 2024
% Change FY 2025
FY 2024
% Change
Total revenues $ 3,884 $ 3,789 3 % $ 14,343 $ 14,202 1 %
GAAP net income $ 845 $ 918 (8 %) $ 4,505 $ 4,413 2 %
GAAP net income per share – diluted $ 7.86 $ 8.06 (2 %) $ 41.48 $ 38.34 8 %
Non-GAAP net income(a) $ 1,249 $ 1,390 (10 %) $ 4,888 $ 5,319 (8 %)
Non-GAAP net income per share – diluted(a) $ 11.44 $ 12.07 (5 %) $ 44.31 $ 45.62 (3 %)
"2025 was another strong year for Regeneron, marked by notable pipeline advances, remarkable commercial execution, and solid financial performance," said Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "As we look ahead to 2026, our focus remains on prioritizing internal investments, evaluating complementary business development opportunities, and enhancing shareholder returns through share repurchases and dividends, positioning the Company to deliver sustainable growth and long-term value to shareholders."
Business Highlights
Key Pipeline Progress
Regeneron has approximately 45 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:
Dupixent (dupilumab)
In November 2025, the European Commission (EC) approved Dupixent for the treatment of CSU in adults and adolescents aged 12 years and older who remain symptomatic despite antihistamine treatment. Dupixent is approved for CSU in certain adults and adolescents in several countries, including the United States and Japan. Additionally, regulatory applications are under review for CSU in children aged 2 to 11 years in the United States, European Union (EU), and Japan.
In December 2025, the Ministry of Health, Labour and Welfare (MHLW) in Japan approved Dupixent for the treatment of bronchial asthma in children aged 6 to 11 years with severe or refractory disease whose symptoms are inadequately controlled with existing therapy. This expands the previous approval of this indication in Japan for patients aged 12 years and older.
In November 2025, the Company and Sanofi announced positive results from the Phase 3 trial in adults and children aged 6 years and older with allergic fungal rhinosinusitis (AFRS). Additionally, the U.S. Food and Drug Administration (FDA) accepted for priority review the supplemental Biologics License Application (sBLA) for this indication, which has a target action date in February 2026.
EYLEA HD (aflibercept) 8 mg
In November 2025, the FDA approved EYLEA HD for the treatment of patients with RVO with up to every 8-week dosing after an initial monthly dosing period. The FDA also approved an every 4-week (monthly) dosing option across approved indications: wet age-related macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR), and RVO.
In January 2026, the EC approved EYLEA 8 mg (known as EYLEA HD in the United States) for the treatment of RVO.
In December 2025, the FDA approved the addition of a new manufacturer to fill vials for EYLEA HD.
In December 2025, the Company submitted a regulatory application to the FDA to include a new manufacturer to fill pre-filled syringes for EYLEA HD. An FDA decision is expected in the second quarter of 2026.
Libtayo (cemiplimab)
In October and November of 2025, the FDA and EC, respectively, approved Libtayo as an adjuvant treatment for adults with CSCC at high risk of recurrence after surgery and radiation, making Libtayo the first and only immunotherapy approved in this setting. This expands Libtayo’s approved indications in CSCC beyond the metastatic or locally advanced setting. Additionally, in December 2025, a regulatory application was submitted in Japan for the adjuvant treatment of CSCC.
Other Programs
In December 2025, the Company submitted a BLA to the FDA for DB-OTO (an AAV-based gene therapy) for the treatment of profound genetic hearing loss in children due to variants of the otoferlin (OTOF) gene. An FDA decision is expected in the first half of 2026.
In December 2025, the Company submitted U.S. and EU regulatory applications for garetosmab (an Activin A antibody) in adults with fibrodysplasia ossificans progressiva (FOP).
A second Phase 3 study was initiated for REGN5713-5715, an investigational treatment for birch allergy.
Corporate Updates
In October 2025, Dupixent was recognized as the "Best Biotechnology Product" of 2025 by the Galien Foundation, which acknowledges extraordinary scientific innovations that improve the human condition.
In January 2026, the Company’s collaboration agreement with Tessera Therapeutics, Inc. to develop and commercialize TSRA-196 (Tessera’s investigational program for the treatment of alpha-1 antitrypsin deficiency (AATD)) became effective. Tessera will lead the initial first-in-human trial, while Regeneron will lead subsequent global development and commercialization.
In addition to the previously announced ongoing and planned domestic investments totaling more than $7 billion, the Company plans to invest approximately $2 billion to develop a state-of-the-art bulk manufacturing facility in Saratoga Springs, New York, expected to create 1,000 high-paying jobs and to significantly expand manufacturing capacity.
Select Upcoming 2026 Milestones
Programs Milestones
Ophthalmology - FDA decision for EYLEA HD pre-filled syringe (second quarter 2026)
- Report initial results from lead-in cohort of Phase 3 study for cemdisiran (C5 siRNA therapy) as monotherapy and in combination with pozelimab (C5 antibody) in geographic atrophy (second half 2026)
Immunology & Inflammation - EC decision on regulatory submission for Dupixent in bullous pemphigoid (first half 2026); FDA decision on sBLA for Dupixent in AFRS (February 2026)
- Initiate long-acting IL-13 antibody clinical program in atopic dermatitis (first half 2026)
- Initiate second Phase 3 study for REGN1908-1909 (Fel d 1 multi-antibody) in cat allergy (first half 2026)
Cardiovascular & Metabolic Diseases - Initiate Phase 3 program for olatorepatide (GLP-1/GIP receptor agonist) in obesity in patients with and without Type 2 diabetes (2026)
- Initiate clinical program for olatorepatide in combination with Praluent (alirocumab) (2026)
- Report additional data from Phase 2 study for semaglutide in combination with trevogrumab (myostatin antibody) with and without garetosmab (Activin A antibody) in obesity (2026)
Hematology - Initiate additional Phase 3 studies for Factor XI antibodies (REGN7508 and REGN9933) in anticoagulation (first half 2026)
- Report results from Phase 3 study for pozelimab (C5 antibody) in combination with cemdisiran (C5 siRNA therapy) in paroxysmal nocturnal hemoglobinuria (PNH) (fourth quarter 2026/first quarter 2027)
Oncology & Hematology-Oncology - Report results from Phase 3 study for fianlimab (LAG-3 antibody), in combination with Libtayo, versus pembrolizumab in first-line metastatic melanoma (first half 2026)
- Initiate additional Phase 3 studies for Lynozyfic (linvoseltamab) in multiple myeloma and precursor conditions (2026)
Neurology & Rare Diseases - FDA decision on BLA for DB-OTO (AAV-based gene therapy) in hearing deficit due to variants of the otoferlin gene (first half 2026)
- FDA decision on BLA and EC decision on MAA for garetosmab (Activin A antibody) in FOP (second half 2026)
- Submit New Drug Application (NDA) for cemdisiran (C5 siRNA therapy) in myasthenia gravis (first quarter 2026) and FDA decision on NDA (fourth quarter 2026/first quarter 2027)
Fourth Quarter and Full Year 2025 Financial Results
Revenues
($ in millions) Q4 2025
Q4 2024
% Change FY 2025
FY 2024
% Change
Net product sales:
EYLEA HD – U.S. $ 506 $ 305 66 % $ 1,637 $ 1,201 36 %
EYLEA – U.S. 577 1,190 (52 %) 2,748 4,767 (42 %)
Total EYLEA HD and EYLEA – U.S. 1,083 1,495 (28 %) 4,385 5,968 (27 %)
Libtayo – U.S. 285 251 14 % 945 787 20 %
Libtayo – ROW* 140 116 21 % 508 430 18 %
Total Libtayo – Global 425 367 16 % 1,453 1,217 19 %
Praluent – U.S. 73 63 16 % 262 242 8 %
Evkeeza- U.S. 48 38 26 % 162 126 29 %
Inmazeb- U.S. 37 40 (8 %) 37 76 (51 %)
Other products – Global 9 — ** 10 — **
Total net product sales 1,675 2,003 (16 %) 6,309 7,629 (17 %)
Collaboration revenue:
Sanofi 1,640 1,213 35 % 5,884 4,531 30 %
Bayer 319 377 (15 %) 1,422 1,499 (5 %)
Other 12 17 (29 %) 25 28 (11 %)
Other revenue 238 179 33 % 703 515 37 %
Total revenues $ 3,884 $ 3,789 3 % $ 14,343 $ 14,202 1 %
* Rest of world (ROW)
** Percentage not meaningful
Net product sales of EYLEA HD increased in the fourth quarter and full year 2025, compared to the same periods of 2024, due to higher sales volumes driven by increased demand, partly offset by a lower net selling price.
Net product sales of EYLEA in the fourth quarter and full year 2025, compared to the same periods of 2024, were negatively impacted by (i) lower sales volumes as a result of continued competitive pressures, loss in market share to compounded bevacizumab due to patient affordability constraints, and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.
In addition, as previously reported, EYLEA HD and EYLEA net product sales in the fourth quarter of 2025 were each favorably impacted by approximately $30 million due to higher wholesaler inventory levels at the end of the fourth quarter of 2025 compared to the end of the third quarter of 2025.
Sanofi collaboration revenue increased in the fourth quarter and full year 2025, compared to the same periods of 2024, due to an increase in the Company’s share of profits from the commercialization of antibodies, which were $1.486 billion and $1.043 billion in the fourth quarter of 2025 and 2024, respectively, and $5.242 billion and $3.924 billion for full year 2025 and 2024, respectively. The change in the Company’s share of profits from commercialization of antibodies was driven by higher profits primarily associated with an increase in Dupixent sales.
Refer to Table 4 for a summary of collaboration revenue.
Other revenue increased in the fourth quarter and full year 2025, compared to the same periods of 2024, primarily due to royalties earned on sales of Ilaris and share of profits from sales of ARCALYST, which were $179 million and $112 million in the aggregate for the fourth quarter of 2025 and 2024, respectively, and $506 million and $293 million for full year 2025 and 2024, respectively.
Operating Expenses
GAAP % Change
Non-GAAP(a) % Change
($ in millions) Q4 2025 Q4 2024 Q4 2025 Q4 2024
Research and development (R&D) $ 1,626 $ 1,412 15 % $ 1,331 $ 1,224 9 %
Acquired in-process research and development (IPR&D) $ 19 $ 14 36 % *
*
n/a
Selling, general, and administrative (SG&A) $ 775 $ 792 (2 %) $ 691 $ 681 1 %
Cost of goods sold (COGS) $ 319 $ 327 (2 %) $ 257 $ 271 (5 %)
Gross margin on net product sales(b) 81% 84% 85% 86%
Cost of collaboration and contract manufacturing (COCM)(c) $ 266 $ 239 11 % *
*
n/a
Other operating (income) expense, net $ — $ 16 (100 %) *
$ — **
GAAP % Change
Non-GAAP(a) % Change
FY 2025 FY 2024 FY 2025 FY 2024
Research and development $ 5,850 $ 5,132 14 % $ 5,150 $ 4,563 13 %
Acquired in-process research and development $ 124 $ 101 23 % * * n/a
Selling, general, and administrative $ 2,700 $ 2,954 (9 %) $ 2,311 $ 2,544 (9 %)
Cost of goods sold $ 1,141 $ 1,087 5 % $ 924 $ 898 3 %
Gross margin on net product sales(b) 82% 86% 85% 88%
Cost of collaboration and contract manufacturing(c) $ 960 $ 883 9 % * *
n/a
Other operating (income) expense, net $ (10 ) $ 53 ** * $ — **
* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded
** Percentage not meaningful
GAAP and non-GAAP R&D expenses increased for full year 2025, compared to the same period in the prior year, driven by the advancement of the Company’s late-stage clinical pipeline. GAAP R&D expenses for the fourth quarter and full year 2025 included $155 million related to a previously purchased FDA Rare Pediatric Disease Priority Review Voucher (PRV), which the Company decided in the fourth quarter of 2025 to utilize for a regulatory submission.
Acquired IPR&D expenses for full year 2025 included an $80 million up-front payment in connection with the Company’s license agreement with Hansoh Pharmaceuticals Group Company Limited. Acquired IPR&D expenses for full year 2024 included a $45 million development milestone in connection with the Company’s collaboration agreement with Sonoma Biotherapeutics, Inc.
GAAP and non-GAAP SG&A expenses decreased for full year 2025, compared to the same period in the prior year, primarily due to lower charitable contributions to Good Days, an independent non-profit patient assistance organization. GAAP and non-GAAP SG&A expenses in the fourth quarter 2025 included approximately $60 million for matching donations made to Good Days; in July 2025, the Company launched a matching program for donations made to Good Days and committed to matching donations quarterly through the end of 2025. The Company recently committed to matching donations for up to a total of $200 million during 2026.
GAAP and non-GAAP gross margin on net product sales decreased in the fourth quarter and full year 2025, compared to the same periods in the prior year, partly due to ongoing investments to support the Company’s manufacturing operations and higher inventory write-offs and reserves. In addition, GAAP gross margin on net product sales decreased due to higher amortization expense associated with the Company’s Libtayo intangible asset.
Other Financial Information
GAAP other income (expense), net included the recognition of net losses on marketable and other securities of $22 million in the fourth quarter of 2025, compared to net losses of $213 million in the fourth quarter of 2024. GAAP other income (expense), net included the recognition of net gains on marketable and other securities of $946 million for full year 2025, compared to net gains of $118 million for full year 2024.
In the fourth quarter and full year 2025, the Company’s GAAP effective tax rate (ETR) was 19.1% and 13.9%, respectively, compared to 4.2% and 7.7% in the fourth quarter and full year 2024, respectively. The GAAP ETR increased in the fourth quarter and full year 2025, compared to the same periods in the prior year, primarily due to lower tax benefits from less stock option exercises and the shortfall related to stock-based compensation. A shortfall occurs when the actual tax deduction a company recognizes from stock-based compensation is less than the deferred tax asset that was previously recorded for financial reporting purposes, resulting in the write-off of the deferred tax asset (and recognition of income tax expense). The GAAP ETR for the fourth quarter of 2025 was also negatively impacted by a lower benefit from income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate. The GAAP ETR for full year 2025 was positively impacted by the release of liabilities for uncertain tax positions recognized upon the settlement of an IRS audit. In the fourth quarter and full year 2025, the non-GAAP ETR was 17.1% and 12.6%, respectively, compared to 9.9% and 9.6% in the fourth quarter and full year 2024, respectively.
A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.
Capital Allocation
During the fourth quarter and full year 2025, the Company repurchased shares of its common stock and recorded the cost of the shares, or $671 million and $3.5 billion, respectively, as Treasury Stock. As of December 31, 2025, $1.5 billion remained available for share repurchases under the Company’s share repurchase programs.
In January 2026, the Company’s board of directors declared a cash dividend of $0.94 per share on the Company’s common stock and Class A stock, payable on March 5, 2026 to shareholders of record as of February 20, 2026.
2026 Financial Guidance*
The Company’s full year 2026 financial guidance consists of the following components:
2026 Guidance
GAAP R&D $6.450–$6.680 billion
Non-GAAP R&D(a) $5.900–$6.100 billion
GAAP SG&A $2.860–$3.040 billion
Non-GAAP SG&A(a) $2.500–$2.650 billion
GAAP gross margin on net product sales 79%–80%
Non-GAAP gross margin on net product sales(a) 83%–84%
COCM** $940 million–$1.020 billion
Capital expenditures** $1.100–$1.300 billion
GAAP effective tax rate 12%–14%
Non-GAAP effective tax rate(a) 13%–15%
* The Company’s 2026 financial guidance does not assume the completion of any business development transactions not completed as of the date of this press release
** GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments are expected to be recorded
A reconciliation of full year 2026 GAAP to non-GAAP financial guidance is included below:
Projected Range
($ in millions) Low High
GAAP R&D $ 6,450 $ 6,680
Stock-based compensation expense 550 580
Non-GAAP R&D(a) $ 5,900 $ 6,100
GAAP SG&A $ 2,860 $ 3,040
Stock-based compensation expense 360 390
Non-GAAP SG&A(a) $ 2,500 $ 2,650
GAAP gross margin on net product sales 79% 80%
Intangible asset amortization expense 3% 3%
Stock-based compensation expense 1% 1%
Non-GAAP gross margin on net product sales(a) 83% 84%
GAAP ETR 12% 14%
Income tax effect of GAAP to non-GAAP reconciling items 1% 1%
Non-GAAP ETR(a) 13% 15%
Conference Call Information
Regeneron will host a conference call and simultaneous webcast to discuss its fourth quarter and full year 2025 financial and operating results on Friday, January 30, 2026, at 8:30 AM Eastern Time. Participants may access the conference call live via webcast, or register in advance and participate via telephone, on the "Investors and Media" page of Regeneron’s website at www.regeneron.com. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.
(Press release, Regeneron, JAN 30, 2026, View Source [SID1234662371])