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Regeneron Reports Fourth Quarter and Full Year 2025 Financial and Operating Results

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Regeneron (NASDAQ: REGN) reported Q4 2025 revenues of $3.884B (up 3% YoY) and full-year 2025 revenues of $14.343B (up 1% YoY). Q4 GAAP EPS was $7.86 and non-GAAP EPS was $11.44. Key commercial drivers included strong Dupixent and EYLEA HD performance and increased Sanofi collaboration revenue.

Regeneron secured multiple regulatory approvals for EYLEA HD, Dupixent and Libtayo and filed BLAs/NDAs for programs including DB-OTO and garetosmab. The company plans substantial manufacturing and R&D investments in 2026.

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Positive

  • Dupixent global net sales +26% to $17.8B (FY 2025)
  • EYLEA HD U.S. net sales +36% to $1.6B (FY 2025)
  • Sanofi collaboration revenue +30% to $5.884B (FY 2025)
  • Q4 non-GAAP EPS of $11.44 supports profitability

Negative

  • Total net product sales declined 17% to $6.309B (FY 2025)
  • Total EYLEA HD and EYLEA U.S. net sales down 27% to $4.385B (Q4 2025 vs Q4 2024)
  • GAAP net income Q4 decreased 8% YoY to $845M

Key Figures

Q4 2025 Total Revenues: $3,884M FY 2025 Total Revenues: $14,343M Q4 2025 GAAP EPS: $7.86 +5 more
8 metrics
Q4 2025 Total Revenues $3,884M Up 3% vs Q4 2024 ($3,789M)
FY 2025 Total Revenues $14,343M Up 1% vs FY 2024 ($14,202M)
Q4 2025 GAAP EPS $7.86 Diluted, vs $8.06 in Q4 2024 (includes $0.14 IPR&D impact)
Q4 2025 Non-GAAP EPS $11.44 Diluted, vs $12.07 in Q4 2024
Q4 2025 Dupixent Net Sales $4,900M Global net sales, up 34% vs Q4 2024
FY 2025 Dupixent Net Sales $17,800M Global net sales, up 26% vs 2024
Q4 2025 EYLEA HD U.S. Sales $506M Up 66% vs Q4 2024 ($305M)
Q4 2025 Total EYLEA U.S. Sales $1,083M EYLEA HD + EYLEA U.S., down 28% vs Q4 2024

Market Reality Check

Price: $741.45 Vol: Volume 900,512 is close t...
normal vol
$741.45 Last Close
Volume Volume 900,512 is close to the 20-day average of 874,157 (relative volume 1.03x). normal
Technical Price $749.44 trades above the 200-day MA at $617.65 and about 8.73% below the 52-week high.

Peers on Argus

REGN was modestly lower pre-news (-0.22%) while key biotech peers were mixed: AL...

REGN was modestly lower pre-news (-0.22%) while key biotech peers were mixed: ALNY -0.74%, VRTX -0.70%, ARGX +0.29%, INSM +2.16%, ONC flat. Movements do not indicate a coordinated sector move.

Previous Earnings Reports

5 past events · Latest: Oct 28 (Positive)
Same Type Pattern 5 events
Date Event Sentiment Move Catalyst
Oct 28 Q3 2025 earnings Positive +11.8% Q3 2025 revenue and EPS growth with strong Dupixent and Libtayo performance.
Aug 01 Q2 2025 earnings Positive +2.5% Q2 2025 revenue growth, EPS expansion, regulatory wins, and capital returns.
Apr 29 Q1 2025 earnings Neutral -6.9% Mixed Q1 2025 with Dupixent growth and EYLEA decline alongside multiple approvals.
Oct 31 Q3 2024 earnings Positive -9.2% Strong Q3 2024 growth across Dupixent, EYLEA franchise, and Libtayo with higher EPS.
Aug 01 Q2 2024 earnings Positive +1.3% Q2 2024 double-digit revenue and EPS growth, led by Dupixent and Libtayo.
Pattern Detected

Earnings have often prompted sizable moves, with mostly positive reactions to strong quarters but occasional selloffs even on good results.

Recent Company History

Across the last five earnings releases from Aug 2024 to Oct 2025, Regeneron reported consistent revenue growth driven by Dupixent, offset by EYLEA franchise pressure and mix shifts toward EYLEA HD. GAAP and non-GAAP EPS generally trended higher, with some quarters impacted by IPR&D charges. Market reactions ranged from a +11.82% jump on strong Q3 2025 results to a -9.17% drop after robust Q3 2024 numbers, showing that earnings days can be volatile and not always directionally tied to fundamentals.

Historical Comparison

earnings
+6.3 %
Average Historical Move
Historical Analysis

In the past five earnings releases, REGN’s average move was about 6.32%, with reactions ranging from sharp gains to notable declines despite generally solid fundamentals.

Typical Pattern

Earnings since mid-2024 show steady revenue growth led by Dupixent, rising contribution from EYLEA HD, and persistent pressure on the broader EYLEA franchise, while EPS trends reflect both operating leverage and periodic IPR&D charges.

Market Pulse Summary

This announcement detailed low-single-digit revenue growth to $3.88B in Q4 and $14.34B for 2025, wit...
Analysis

This announcement detailed low-single-digit revenue growth to $3.88B in Q4 and $14.34B for 2025, with strong Dupixent and EYLEA HD trends offset by broader EYLEA weakness and some EPS pressure. The update emphasized roughly 45 clinical programs, multiple 2026 regulatory decisions, and significant manufacturing investments. Investors may focus on the balance between Dupixent-driven growth, EYLEA erosion, and how R&D and capacity spending shape future profitability and pipeline execution.

Key Terms

gaap, non-gaap, in-process research and development, priority review, +3 more
7 terms
gaap financial
"Fourth quarter 2025 GAAP EPS of $7.86 and non-GAAP EPS(a) of $11.44;"
GAAP, or Generally Accepted Accounting Principles, are a set of standardized rules and guidelines that companies follow when preparing their financial statements. They ensure consistency, transparency, and comparability across different companies, making it easier for investors to understand and compare financial information accurately. This helps investors make informed decisions based on trustworthy and uniform financial reports.
non-gaap financial
"Fourth quarter 2025 GAAP EPS of $7.86 and non-GAAP EPS(a) of $11.44;"
Non-GAAP refers to financial measures that companies use to show their earnings or performance without including certain expenses or income that are often added back to give a different picture. It matters because it can make a company's results look better or more favorable, but it may also hide important costs, so investors need to look at both GAAP (official rules) and non-GAAP numbers to get a full understanding.
in-process research and development financial
"Acquired in-process research and development (IPR&D) | | $19 | | $14"
Unfinished research and development work—such as drug candidates, prototypes, or process designs—that a company is actively developing but has not yet completed or commercialized. Investors care because it represents potential future products or technologies (like a half-built prototype) whose value is uncertain; it affects how acquisitions are priced, how future profits and costs are forecast, and can be written down if the project fails.
priority review regulatory
"FDA accepted for priority review the supplemental Biologics License Application (sBLA)"
Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.
biologics license application regulatory
"FDA accepted for priority review the supplemental Biologics License Application (sBLA)"
A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.
nda regulatory
"Submit New Drug Application (NDA) for cemdisiran (C5 siRNA therapy) in myasthenia"
An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.
maa regulatory
"FDA decision on BLA and EC decision on MAA for garetosmab (Activin A antibody)"
MAA stands for Marketing Authorization Application, the formal request a drug developer files with regulators (commonly in the European Union) asking for permission to sell a medicine. Think of it like applying for a driver’s license for a product: approval means the company can market and earn revenue from the drug, while rejection or delays affect expected sales, timelines and the company’s valuation—so investors track MAAs as key risk/reward milestones.

AI-generated analysis. Not financial advice.

  • Fourth quarter 2025 revenues increased 3% to $3.9 billion versus fourth quarter 2024; full year 2025 revenues increased 1% to $14.3 billion versus 2024
  • Fourth quarter 2025 Dupixent® global net sales (recorded by Sanofi) increased 34% to $4.9 billion versus fourth quarter 2024; full year 2025 Dupixent global net sales increased 26% to $17.8 billion versus 2024
  • Fourth quarter 2025 EYLEA HD® U.S. net sales increased 66% to $506 million and total EYLEA HD and EYLEA® U.S. net sales decreased 28% to $1.1 billion; full year 2025 EYLEA HD U.S. net sales increased 36% to $1.6 billion and total EYLEA HD and EYLEA U.S. net sales decreased 27% to $4.4 billion
  • Fourth quarter 2025 GAAP EPS of $7.86 and non-GAAP EPS(a) of $11.44; fourth quarter 2025 includes unfavorable $0.14 impact from acquired IPR&D charge
  • EYLEA HD approved by FDA for treatment of macular edema following retinal vein occlusion (RVO) and for monthly dosing flexibility across approved indications
  • FDA approved new manufacturer to fill vials for EYLEA HD; regulatory application to include new manufacturer for EYLEA HD pre-filled syringe submitted to FDA, with decision expected in second quarter 2026
  • Libtayo® approved by FDA and EC as first and only immunotherapy for high-risk adjuvant cutaneous squamous cell carcinoma (CSCC)
  • Dupixent approved by EC for chronic spontaneous urticaria (CSU)

TARRYTOWN, N.Y., Jan. 30, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the fourth quarter and full year 2025 and provided a business update.

"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 sales79%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 rate12%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% 


(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 other operating (income) expense, net, 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.


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.

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.

For more information, please visit www.regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook, or X.

Forward-Looking Statements and Use of Digital Media

This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates"); uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties or other factors beyond Regeneron's control on the commercial success of Regeneron's Products and Regeneron's Product Candidates; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and Regeneron's Product Candidates and research and clinical programs now underway or planned, including without limitation EYLEA HD® (aflibercept) Injection 8 mg, EYLEA® (aflibercept) Injection, Dupixent® (dupilumab), Libtayo® (cemiplimab), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab), Veopoz® (pozelimab), Ordspono (odronextamab), Lynozyfic (linvoseltamab), other clinical programs discussed in this press release, Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs; the likelihood and timing of achieving any of the anticipated milestones described in this press release; safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron's Product Candidates in clinical trials; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, including those listed above and/or otherwise discussed in this press release; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; the ability of Regeneron’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron's Product Candidates; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron's drug pricing strategy; other changes in laws, regulations, and policies affecting the healthcare industry; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance, including GAAP and non-GAAP R&D, GAAP and non-GAAP SG&A, GAAP and non-GAAP gross margin on net product sales, COCM, capital expenditures, and GAAP and non-GAAP ETR; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).

Non-GAAP Financial Measures

This press release and/or the financial results attached to this press release include amounts that are considered "non-GAAP financial measures" under SEC rules. As required, Regeneron has provided reconciliations of such non-GAAP financial measures.

Contact Information:  
   
Ryan Crowe Christina Chan
Investor Relations Corporate Affairs
914-847-8790 914-847-8827
ryan.crowe@regeneron.com christina.chan@regeneron.com


TABLE 1

REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
(In millions)

  
  December 31,
   2025   2024 
Assets:      
Cash and marketable securities $18,865.8  $17,912.6 
Accounts receivable, net  5,741.1   6,211.9 
Inventories  3,200.8   3,087.3 
Property, plant, and equipment, net  5,120.4   4,599.7 
Intangible assets, net  1,257.4   1,148.6 
Deferred tax assets  4,077.2   3,314.1 
Other assets  2,296.0   1,485.2 
Total assets $40,558.7  $37,759.4 
       
Liabilities and stockholders' equity:      
Accounts payable, accrued expenses, and other liabilities $5,834.2  $4,888.0 
Finance lease liabilities  720.0   720.0 
Deferred revenue  761.7   813.4 
Long-term debt  1,985.9   1,984.4 
Stockholders' equity  31,256.9   29,353.6 
Total liabilities and stockholders' equity $40,558.7  $37,759.4 


TABLE 2

REGENERON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(In millions, except per share data)
 
  Three Months Ended
December 31,
 Year Ended
December 31,
   2025   2024   2025   2024 
Revenues:        
Net product sales $1,674.8  $2,002.9  $6,309.1  $7,629.2 
Collaboration revenue  1,970.9   1,606.9   7,331.2   6,057.8 
Other revenue  238.6   179.4   702.6   515.0 
   3,884.3   3,789.2   14,342.9   14,202.0 
Expenses:        
Research and development  1,626.1   1,412.1   5,850.2   5,132.0 
Acquired in-process research and development  18.7   13.8   124.1   101.0 
Selling, general, and administrative  775.0   792.2   2,700.0   2,954.4 
Cost of goods sold  318.7   326.8   1,140.8   1,087.3 
Cost of collaboration and contract manufacturing  265.9   238.6   959.9   883.2 
Other operating (income) expense, net     15.5   (10.0)  53.4 
   3,004.4   2,799.0   10,765.0   10,211.3 
         
Income from operations  879.9   990.2   3,577.9   3,990.7 
         
Other income (expense):        
Other income (expense), net  176.0   (21.6)  1,696.6   844.4 
Interest expense  (12.2)  (10.5)  (43.8)  (55.2)
   163.8   (32.1)  1,652.8   789.2 
         
Income before income taxes  1,043.7   958.1   5,230.7   4,779.9 
         
Income tax expense  199.1   40.4   725.8   367.3 
         
Net income $844.6  $917.7  $4,504.9  $4,412.6 
         
Net income per share - basic $8.21  $8.53  $43.07  $40.90 
Net income per share - diluted $7.86  $8.06  $41.48  $38.34 
         
Weighted average shares outstanding - basic  102.9   107.6   104.6   107.9 
Weighted average shares outstanding - diluted  107.5   113.8   108.6   115.1 


TABLE 3

REGENERON PHARMACEUTICALS, INC.
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited)
(In millions, except per share data)
 
  Three Months Ended
December 31,
 Year Ended
December 31,
   2025   2024   2025   2024 
GAAP R&D $1,626.1  $1,412.1  $5,850.2  $5,132.0 
Stock-based compensation expense  140.3   174.7   545.4   543.8 
Acquisition and integration costs     13.8      24.9 
Priority review voucher  155.0      155.0    
Non-GAAP R&D $1,330.8  $1,223.6  $5,149.8  $4,563.3 
         
GAAP SG&A $775.0  $792.2  $2,700.0  $2,954.4 
Stock-based compensation expense  83.9   103.1   362.9   355.0 
Acquisition and integration costs     5.5   0.8   42.2 
Litigation settlements     3.0   25.0   13.0 
Non-GAAP SG&A $691.1  $680.6  $2,311.3  $2,544.2 
         
GAAP COGS $318.7  $326.8  $1,140.8  $1,087.3 
Stock-based compensation expense  25.1   26.6   85.4   84.0 
Acquisition and integration costs     0.3      2.0 
Intangible asset amortization expense  36.9   29.1   131.7   103.5 
Non-GAAP COGS $256.7  $270.8  $923.7  $897.8 
         
GAAP other operating (income) expense, net $  $15.5  $(10.0) $53.4 
Change in fair value of contingent consideration     15.5      53.4 
Non-GAAP other operating (income) expense, net $  $  $(10.0) $ 
         
GAAP other income (expense), net $163.8  $(32.1) $1,652.8  $789.2 
Losses (gains) on marketable and other securities, net  21.5   212.9   (946.1)  (118.3)
Non-GAAP other income (expense), net $185.3  $180.8  $706.7  $670.9 
         
GAAP net income $844.6  $917.7  $4,504.9  $4,412.6 
Total of GAAP to non-GAAP reconciling items above  462.7   584.5   360.1   1,103.5 
Income tax effect of GAAP to non-GAAP reconciling items  (91.4)  (112.5)  (54.4)  (196.9)
Income tax expense: Shortfall from stock-based compensation  32.6      32.6    
Income tax expense: Charge related to enactment of OBBBA        44.5    
Non-GAAP net income $1,248.5  $1,389.7  $4,887.7  $5,319.2 
         
Non-GAAP net income per share - basic $12.13  $12.92  $46.73  $49.30 
Non-GAAP net income per share - diluted $11.44  $12.07  $44.31  $45.62 
         
Shares used in calculating:        
Non-GAAP net income per share - basic  102.9   107.6   104.6   107.9 
Non-GAAP net income per share - diluted  109.1   115.1   110.3   116.6 


 
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited)(continued)
 
  Three Months Ended
December 31,
 Year Ended
December 31,
  2025  2024  2025 2024
Effective tax rate reconciliation:        
GAAP ETR 19.1%  4.2%  13.9% 7.7%
Income tax effect of GAAP to non-GAAP reconciling items 0.2%  5.7%  0.1% 1.9%
Income tax expense: Shortfall from stock-based compensation (2.2%)  %  (0.6%) %
Income tax expense: Charge related to enactment of OBBBA %  %  (0.8%) %
Non-GAAP ETR 17.1%  9.9%  12.6% 9.6%
         
Gross margin on net product sales reconciliation:        
GAAP gross margin on net product sales 81%  84%  82% 86%
Intangible asset amortization expense 2%  1%  2% 1%
Stock-based compensation expense 2%  1%  1% 1%
Non-GAAP gross margin on net product sales 85%  86%  85% 88%
         
    Year Ended
December 31,
  
    2025 2024  
Free cash flow reconciliation:        
Net cash provided by operating activities   $4,978.9  $4,420.5   
Capital expenditures    (898.4)  (755.9)  
Free cash flow   $4,080.5  $3,664.6   


TABLE 4

REGENERON PHARMACEUTICALS, INC.
COLLABORATION REVENUE (Unaudited)
(In millions)

  
  Three Months Ended
December 31,
 Year Ended
December 31,
   2025   2024   2025   2024 
Sanofi collaboration revenue:            
Regeneron's share of profits in connection with commercialization of antibodies $1,485.9  $1,042.9  $5,241.6  $3,923.5 
Reimbursement for manufacturing of commercial supplies  154.3   169.7   642.4   607.9 
Total Sanofi collaboration revenue  1,640.2   1,212.6   5,884.0   4,531.4 
             
Bayer collaboration revenue:            
Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States  270.1   348.8   1,282.7   1,403.3 
Reimbursement for manufacturing of commercial supplies  48.6   28.3   139.7   95.7 
Total Bayer collaboration revenue  318.7   377.1   1,422.4   1,499.0 
             
Other collaboration revenue  12.0   17.2   24.8   27.4 
             
Total collaboration revenue $1,970.9  $1,606.9  $7,331.2  $6,057.8 


TABLE 5

REGENERON PHARMACEUTICALS, INC.
NET PRODUCT SALES OF REGENERON-DISCOVERED PRODUCTS (Unaudited)
(In millions)
 
  Three Months Ended
December 31,
  
  2025
 2024
 % Change
  U.S.
 ROW
 Total
 U.S.
 ROW
 Total
 (Total Sales)
EYLEA HD(a) $506.3  $312.2  $818.5  $304.6  $90.4  $395.0  107%
EYLEA(a) $576.9  $504.8  $1,081.7  $1,190.4  $797.5  $1,987.9  (46%)
Total EYLEA HD and EYLEA $1,083.2  $817.0  $1,900.2  $1,495.0  $887.9  $2,382.9  (20%)
Dupixent(b) $3,733.8  $1,205.7  $4,939.5  $2,745.8  $951.8  $3,697.6  34%
Libtayo(c) $285.3  $140.1  $425.4  $251.2  $115.7  $366.9  16%
Praluent(d) $72.2  $153.6  $225.8  $62.7  $117.7  $180.4  25%
Kevzara(b) $100.0  $52.0  $152.0  $82.4  $52.4  $134.8  13%
Other products(e) $92.9  $31.8  $124.7  $78.5  $24.8  $103.3  21%
                     
  Year Ended
December 31,
  
  2025
 2024
 % Change
  U.S.
 ROW
 Total
 U.S.
 ROW
 Total
 (Total Sales)
EYLEA HD(a) $1,636.9  $932.7  $2,569.6  $1,201.1  $239.9  $1,441.0  78%
EYLEA(a) $2,747.8  $2,573.6  $5,321.4  $4,767.1  $3,336.9  $8,104.0  (34%)
Total EYLEA HD and EYLEA $4,384.7  $3,506.3  $7,891.0  $5,968.2  $3,576.8  $9,545.0  (17%)
Dupixent(b) $13,187.0  $4,619.7  $17,806.7  $10,398.7  $3,749.3  $14,148.0  26%
Libtayo(c) $944.7  $507.5  $1,452.2  $787.3  $429.5  $1,216.8  19%
Praluent(d) $262.5  $594.3  $856.8  $241.7  $523.3  $765.0  12%
Kevzara(b) $371.4  $203.2  $574.6  $270.2  $188.5  $458.7  25%
Other products(e) $210.0  $113.3  $323.3  $202.9  $90.0  $292.9  10%
                     
Note: The table above includes net product sales of Regeneron-discovered products. Such net product sales are recorded by the Company or others, as further described in the footnotes below.
(a) The Company records net product sales of EYLEA HD and EYLEA in the United States, and Bayer records net product sales outside the United States. The Company records its share of profits in connection with sales outside the United States within Collaboration revenue.
(b) Sanofi records global net product sales of Dupixent and Kevzara, and the Company records its share of profits in connection with global sales of such products within Collaboration revenue
(c) The Company records global net product sales of Libtayo and pays Sanofi a royalty on such sales
(d) The Company records net product sales of Praluent in the United States. Sanofi records net product sales of Praluent outside the United States and pays the Company a royalty on such sales, which is recorded within Other revenue.
(e) Included in this line item are products which are sold by the Company and others. Refer to "Fourth Quarter and Full Year 2025 Financial Results" section above for a listing of net product sales recorded by the Company. Not included in this line item are net product sales of ARCALYST, which are recorded by Kiniksa.

FAQ

What were Regeneron (REGN) Q4 2025 revenues and EPS?

Regeneron reported Q4 2025 revenue of $3.884 billion and GAAP EPS of $7.86. According to the company, non-GAAP EPS for Q4 2025 was $11.44, reflecting adjusted earnings excluding certain items.

How did Dupixent sales perform for full year 2025 for REGN?

Dupixent full-year 2025 global net sales increased 26% to $17.8 billion. According to the company, higher Dupixent sales drove increased profit share recorded as Sanofi collaboration revenue.

What regulatory approvals for EYLEA HD did Regeneron announce in early 2026?

EYLEA HD received FDA approval for RVO and monthly dosing flexibility and EC approval in January 2026. According to the company, FDA also approved a new vial filler and a syringe filler decision is expected Q2 2026.

What material near-term regulatory milestones should investors watch for REGN in 2026?

Investors should watch FDA decisions for EYLEA HD pre-filled syringe (Q2 2026) and DB-OTO BLA (first half 2026). According to the company, multiple other NDA/BLA/EC decisions and Phase 3 readouts are scheduled across 2026.

How did EYLEA product sales change in Q4 2025 and what drove the shift?

EYLEA HD U.S. net sales rose 66% to $506 million while total EYLEA U.S. sales fell 28% to $1.083 billion. According to the company, volume gains in EYLEA HD and transition to HD offset price declines and competition.
Regeneron Pharmaceuticals

NASDAQ:REGN

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Biotechnology
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