On July 30, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the second quarter of 2026 and provided a business update.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Regeneron delivered another quarter of strong financial performance, with double-digit top- and bottom-line growth reflecting the continued strength of our commercial portfolio and the potential of our pipeline," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "Of note, global Dupixent, global Libtayo, and U.S. EYLEA HD net product sales increased by 38%, 30%, and 52%, respectively, compared to the second quarter of 2025. With approximately 50 clinical assets, we remain focused on translating our science into even more successful new medicines across a broad array of diseases."
Financial Highlights
($ in millions, except per share data) Q2 2026 Q2 2025 % Change
Total revenues $ 4,291 $ 3,676 17 %
GAAP net income $ 1,297 $ 1,392 (7 %)
GAAP net income per share – diluted $ 12.23 $ 12.81 (5 %)
Non-GAAP net income(a)
$ 1,543 $ 1,424 8 %
Non-GAAP net income per share – diluted(a)
$ 14.29 $ 12.89 11 %
"Second quarter revenues grew 17% and non-GAAP net income per share grew 11%, marking our second consecutive quarter of double-digit growth on both measures," said Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "By the end of the second quarter, we had fully repaid the Sanofi Development Balance, which represented the outstanding amount due to Sanofi for their funding of prior collaboration development activities. The repayment of this obligation will drive a meaningful step-up in collaboration profits beginning in the third quarter. Given our strong financial position, we continue to invest confidently in our pipeline, U.S. manufacturing, and external innovation, while returning capital to shareholders, reflected by the nearly $3.0 billion deployed in the first half of the year to share repurchases, dividends, capital expenditures, and business development."
Business Highlights
Key Pipeline Progress
Regeneron has 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:
Dupixent (dupilumab)
•In April 2026, the U.S. Food and Drug Administration (FDA) and European Commission approved Dupixent for the treatment of chronic spontaneous urticaria (CSU), expanding the eligible population to include children aged 2 to 11 years who remain symptomatic despite antihistamine treatment.
EYLEA HD (aflibercept) 8 mg
•In April 2026, the FDA approved the extension of dosing intervals for EYLEA HD up to every 20 weeks (5 months) for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) following one year of successful response based on visual and anatomic outcomes.
Otarmeni (lunsotogene parvec, formerly known as DB-OTO)
•In May 2026, the European Medicines Agency (EMA) accepted for review, under accelerated assessment, the Marketing Authorization Application (MAA) for Otarmeni for the treatment of biallelic OTOF variant-associated hearing loss.
Fianlimab (LAG-3 antibody)
•In May 2026, the Company announced results from the Phase 3 trial evaluating two dose levels of fianlimab in combination with cemiplimab as a first-line treatment for patients with unresectable locally advanced or metastatic melanoma. The trial did not reach statistical significance for the primary endpoint of improvement in progression-free survival (PFS) compared to pembrolizumab monotherapy.
Other Programs
•In June 2026, the Company announced that both the FDA and EMA have accepted the regulatory applications for cemdisiran (C5 RNAi therapy) to treat adult patients with gMG. The FDA will review the New Drug Application (NDA) under priority review with a target action date in November 2026, following use of a Priority Review Voucher. A decision from the European Commission is anticipated in the second half of 2027.
•The Company announced positive results from the Phase 1/2 LINKER-AL2 trial for Lynozyfic (linvoseltamab) in adults with second-line-plus systemic amyloid light chain amyloidosis. The results were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)
(ASCO) 2026 Annual Meeting. The Phase 2 portion of the trial with registrational intent, part of a broad clinical development program investigating Lynozyfic, is underway.
•A Phase 3 study was initiated in peripheral artery disease (PAD) for cenvacibart (REGN7508, an antibody to Factor XI (catalytic domain)), and amrecibart (REGN9933, an antibody to Factor XI (A2 domain)), to evaluate each antibody individually compared to standard of care.
Corporate Updates
•The FDA selected the Company’s manufacturing facility in Saratoga Springs, New York, which is currently under construction, to participate in the FDA PreCheck Pilot Program. The FDA PreCheck Pilot Program is intended to support the development of new U.S. pharmaceutical manufacturing facilities by encouraging earlier FDA engagement and providing a more predictable regulatory pathway.
•In May 2026, the Company entered into a collaboration with Parabilis Medicines to discover and develop multiple therapeutic candidates based on Parabilis’ Helicon peptide platform.
•The Company announced that it had been named to the Dow Jones Best-in-Class World Index, one of the world’s most recognized benchmarks for corporate sustainability performance, for the seventh consecutive year.
Second Quarter 2026 Financial Results
Revenues
($ in millions) Q2 2026 Q2 2025 % Change
Net product sales:
EYLEA HD – U.S. $ 596 $ 393 52 %
EYLEA – U.S.
412 754 (45 %)
Total EYLEA HD and EYLEA – U.S. 1,008 1,147 (12 %)
Libtayo – U.S. 343 248 38 %
Libtayo – ROW* 146 129 13 %
Total Libtayo – Global
489 377 30 %
Praluent – U.S.
75 66 14 %
Evkeeza – U.S.
53 41 29 %
Lynozyfic – Global
17 — **
Total net product sales 1,642 1,631 1 %
Collaboration revenue:
Sanofi 2,174 1,444 51 %
Bayer 276 415 (33 %)
Other 6 2 **
Other revenue 193 184 5 %
Total revenues $ 4,291 $ 3,676 17 %
Net product sales of EYLEA HD increased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to higher sales volumes driven by increased demand, partly offset by a lower net selling price.
Net product sales of EYLEA in the second quarter of 2026, compared to the second quarter of 2025, were negatively impacted by (i) lower sales volumes, driven by decreased demand, as a result of continued competitive pressures and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.
Global net product sales of Libtayo increased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to higher sales volumes driven by increased demand.
Sanofi collaboration revenue increased in the second quarter of 2026, compared to the second quarter of 2025, due to an increase in the Company’s share of profits from the commercialization of antibodies, which were $2.033 billion and $1.282 billion in the second quarter of 2026 and 2025, respectively. The change in the Company’s share of profits from the commercialization of antibodies was driven by higher profits primarily associated with an increase in Dupixent sales. In addition, the Sanofi Development Balance was fully repaid as of the end of the second quarter of 2026 and will no longer reduce Sanofi collaboration revenue beginning in the third quarter of 2026.
Refer to Table 4 for a summary of collaboration revenue.
Operating Expenses
GAAP % Change
Non-GAAP(a)
% Change
($ in millions)
Q2 2026 Q2 2025 Q2 2026 Q2 2025
Research and development (R&D) $ 1,632 $ 1,422 15 % $ 1,500 $ 1,283 17 %
Acquired in-process research and development (IPR&D) $ 127 $ 10 ** * * *
Selling, general, and administrative (SG&A) $ 662 $ 634 4 % $ 574 $ 542 6 %
Cost of goods sold (COGS) $ 361 $ 276 31 % $ 221 $ 222 — %
Gross margin on net product sales(b)
78% 83% 87% 86%
Cost of collaboration and contract manufacturing (COCM)(c)
$ 216 $ 255 (15 %) * * *
* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded
** Percentage not meaningful or greater than 100%
•GAAP and non-GAAP R&D expenses increased in the second quarter of 2026, compared to the second quarter of 2025, driven by the Company’s mid- and late-stage clinical pipeline.
•Acquired IPR&D expenses for the second quarter of 2026 included up-front and opt-in payments in connection with collaboration and licensing agreements.
•GAAP gross margin on net product sales decreased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to unabsorbed manufacturing costs as a result of the previously disclosed temporary interruption of bulk manufacturing production at the Company’s facility in Limerick, Ireland. As of the end of the second quarter of 2026, bulk manufacturing production returned to normal levels. The interruption did not impact the availability of any of the Company’s products.
Other Financial Information
GAAP other income (expense), net decreased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to lower net gains on marketable and other securities.
In the second quarter of 2026, the Company’s GAAP effective tax rate (ETR) was 15.1%, compared to 8.4% in the second quarter of 2025. The GAAP ETR increased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to the net change in unrecognized tax benefits, as during the second quarter of 2025 the Company released liabilities associated with unrecognized tax benefits upon the settlement of an IRS audit. In the second quarter of 2026, the non-GAAP ETR was 15.5%, compared to 8.3% in the second 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 three and six months ended June 30, 2026, the Company repurchased $1.2 billion and $2.0 billion, respectively, of its common stock. As of June 30, 2026, $2.5 billion remained available for share repurchases under the Company’s share repurchase programs.
In July 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 August 31, 2026 to shareholders of record as of August 18, 2026.
2026 Financial Guidance*
The Company’s full year 2026 financial guidance consists of the following components:
2026 Guidance
Prior
Updated
GAAP R&D $6.450–$6.680 billion $6.500–$6.635 billion
Non-GAAP R&D(a)
$5.900–$6.100 billion $5.950–$6.050 billion
GAAP SG&A
$2.860–$3.040 billion $2.830–$2.960 billion
Non-GAAP SG&A(a)
$2.500–$2.650 billion $2.500–$2.600 billion
GAAP gross margin on net product sales
77%–78% 78%–79%
Non-GAAP gross margin on net product sales(a)
83%–84% 84%–85%
GAAP COCM
$955 million–$1.035 billion
$985 million–$1.035 billion
Non-GAAP COCM(a)
$940 million–$1.020 billion $970 million–$1.020 billion
Capital expenditures
$1.100–$1.200 billion
$1.030–$1.100 billion
GAAP effective tax rate 12%–14% 13%–14%
Non-GAAP effective tax rate(a)
13%–15% 14%–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
(Press release, Regeneron, JUL 30, 2026, View Source [SID1234669546])