Regeneron Reports Second Quarter 2025 Financial and Operating Results

• Second quarter 2025 revenues increased 4% to $3.68 billion versus second quarter 2024
• Dupixent® global net sales (recorded by Sanofi) increased 22% to $4.34 billion
• EYLEA HD® U.S. net sales increased 29% to $393 million; total EYLEA HD and EYLEA® U.S. net sales decreased 25% to $1.15 billion
• GAAP EPS increased 3% to $12.81; non-GAAP EPS(a) increased 12% to $12.89
• FDA approved Lynozyfic™ (linvoseltamab) for relapsed or refractory multiple myeloma and Dupixent for bullous pemphigoid and chronic spontaneous urticaria (CSU)
• FDA accepted for priority review Libtayo® sBLA for adjuvant cutaneous squamous cell carcinoma (CSCC)
• In-licensed rights to late-stage dual GLP-1/GIP receptor agonist; reported interim 26-week data from Phase 2 COURAGE trial in obesity

TARRYTOWN, N.Y., Aug. 01, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the second quarter of 2025 and provided a business update.

"Regeneron had a strong quarter, marked by significant growth in U.S. sales of EYLEA HD and global sales of Dupixent and Libtayo along with multiple regulatory approvals," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "We have made significant progress in our oncology portfolio, including FDA approval for Lynozyfic for relapsed or refractory multiple myeloma, exciting emerging data from the lead-in cohorts of our pivotal programs in myeloma and lymphoma, as well as positive pivotal data supporting a potential upcoming FDA approval for Libtayo in adjuvant CSCC. Dupixent continues to be the world-leading treatment for diseases driven by type 2 inflammation, adding recent FDA approvals for bullous pemphigoid and chronic spontaneous urticaria, the seventh and eighth distinct indications for this important medicine. We are confident in the near- and long-term potential of our diverse pipeline and look forward to additional data and regulatory milestones later this year."

Financial Highlights

($ in millions, except per share data)		Q2 2025				Q2 2024				% Change
Total revenues		$	3,676			$	3,547				4	%
GAAP net income		$	1,392			$	1,432				(3	%)
GAAP net income per share - diluted		$	12.81			$	12.41				3	%
Non-GAAP net income(a)		$	1,424			$	1,351				5	%
Non-GAAP net income per share - diluted(a)		$	12.89			$	11.56				12	%

"We are pleased with our second quarter financial performance, which reflects strong momentum across our business, highlighted by 4% revenue growth and 12% non-GAAP earnings growth," said Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "While we continue to prioritize internal investments, we also returned over $2.3 billion of capital to shareholders through share repurchases and dividends and committed over $7 billion to U.S. manufacturing investments, capital expenditures, and business development since the start of 2025, underscoring our commitment to deploy capital with the goal of driving long-term value creation."

Business Highlights

Key Pipeline ProgressRegeneron 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 June 2025, the FDA approved Dupixent for the treatment of adults with bullous pemphigoid. Regulatory applications are under review in the European Union (EU) and Japan.
• In April 2025, the FDA approved Dupixent for the treatment of adults and adolescents aged 12 years and older with CSU who remain symptomatic despite antihistamine treatment. Regulatory applications were submitted to the FDA and in the EU for CSU in children aged 2 to 11 years.

EYLEA HD (aflibercept) 8 mg

• The European Commission (EC) approved EYLEA 8 mg with extended dosing intervals of up to 6 months (24 weeks) for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).
• The Company now expects regulatory approvals to be delayed for its currently pending FDA applications for EYLEA HD (pre-filled syringe, every-four-week dosing, and for the treatment of macular edema following retinal vein occlusion), which have PDUFA dates in August 2025. The anticipated delay is related to observations from an FDA general site inspection at the filler for EYLEA HD in these regulatory applications, Catalent Indiana LLC (recently acquired by Novo Nordisk A/S). This inspection was completed in mid-July and was not specific to EYLEA HD. Novo has been in communication with the FDA and expects to submit its response next week. Based on the Company's review of the observations and Novo's proposed response to the FDA, along with the progress the Company has made with alternate third-party fillers, the Company anticipates an expeditious resolution of the filling issues for EYLEA HD.

Oncology Programs

• In July 2025, the FDA granted accelerated approval for Lynozyfic (linvoseltamab) to treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. Additionally, the EC granted conditional marketing approval of Lynozyfic to treat adults with relapsed or refractory multiple myeloma who have received at least three prior therapies.
• In July 2025, Lynozyfic was added to the National Comprehensive Cancer Network (NCCN) Guidelines for the treatment of multiple myeloma.
• The FDA accepted for priority review a supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab) in adjuvant CSCC, with a target action date in October 2025.
• The Company announced detailed analyses from a Phase 3 trial of Libtayo in adjuvant CSCC. The results, presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine, included additional data for the primary endpoint of disease-free survival (DFS) and the first presentation of key secondary endpoint outcomes.
• On July 30, 2025, the FDA issued a Complete Response Letter (CRL) for the BLA for odronextamab, a bispecific antibody targeting CD20 and CD3, in relapsed/refractory follicular lymphoma after two or more lines of systemic therapy, which was also impacted by the Catalent Indiana LLC site inspection (as described above).

Other Programs

• The Company announced interim 26-week results from the ongoing Phase 2 COURAGE trial investigating combinations of semaglutide and trevogrumab (myostatin antibody) with or without garetosmab (Activin A antibody) for the treatment of obesity. The trial demonstrated that approximately 35% of semaglutide-induced weight loss was due to loss of lean mass, and further demonstrated that combining semaglutide with trevogrumab with or without garetosmab preserved lean mass while increasing loss of fat mass. Final 26-week efficacy and safety results were consistent with the interim data and will be presented at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD) in September 2025.
• A Phase 3 study for REGN7508, an antibody to Factor XI (catalytic domain), was initiated to evaluate the prevention of venous thromboembolism after total knee replacement surgery. Initiation of additional Phase 3 studies is planned for later this year and the first half of 2026.
• The Company and Sanofi announced that a Phase 3 trial, AERIFY-1, for itepekimab, an antibody to IL-33, in adults who were former smokers with inadequately controlled chronic obstructive pulmonary disease (COPD) met the primary endpoint of significantly reducing moderate or severe acute exacerbations by 27% compared to placebo at week 52, a clinically meaningful benefit. A second Phase 3 trial, AERIFY-2, did not meet the same primary endpoint, although a benefit was seen earlier in the trial. The Company and Sanofi continue to evaluate the data to inform next steps for potential future COPD development.

Corporate and Business Development Updates

• In July 2025, the Company's license agreement with Hansoh Pharmaceuticals Group Company Limited to acquire development and commercial rights outside of mainland China, Hong Kong, and Macau for HS-20094 (a dual GLP-1/GIP receptor agonist currently in Phase 3 clinical development in China) became effective. In-licensing a late-stage GLP1/GIP agonist enables the Company to study combinations with its products and product candidates in order to address muscle loss and potentially other comorbidities of obesity, such as cardiovascular diseases, diabetes, and liver conditions.
• A jury verdict in the U.S. District Court for the District of Delaware found that Amgen Inc. violated antitrust and tort laws by creating an anticompetitive bundling scheme which was designed to exclude Praluent from the market.
• In June 2025, the Company announced the launch of a matching program for donations to Good Days, an independent national non-profit charitable organization, to support their Retinal Vascular and Neovascular Disease Fund. The Company has committed to matching donations up to a total of $200 million at a one-to-one rate through the end of 2025, with the goal of enabling more patients to affordably access essential medicines that help protect their vision.
• The Company acquired an FDA Rare Pediatric Disease Priority Review Voucher from a third party for $155 million.

Second Quarter 2025 Financial Results

Revenues

($ in millions)		Q2 2025				Q2 2024				% Change
Net product sales:
EYLEA HD - U.S.		$	393			$	304				29	%
EYLEA - U.S.			754				1,231				(39	%)
Total EYLEA HD and EYLEA - U.S.			1,147				1,535				(25	%)
Libtayo - U.S.			248				182				36	%
Libtayo - ROW*			129				115				12	%
Total Libtayo - Global			377				297				27	%
Praluent® - U.S.			66				56				18	%
Evkeeza® - U.S.			41				31				32	%
Total net product sales			1,631				1,919				(15	%)
Collaboration revenue:
Sanofi			1,444				1,146				26	%
Bayer			415				375				11	%
Other			2				3				(33	%)
Other revenue			184				104				77	%
Total revenues		$	3,676			$	3,547				4	%
* Rest of world (ROW)

Net product sales of EYLEA HD increased in the second quarter of 2025, compared to the second quarter of 2024, due to higher sales volumes driven by increased demand.

Net product sales of EYLEA in the second quarter of 2025, compared to the second quarter 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.

Sanofi collaboration revenue increased in the second quarter of 2025, compared to the second quarter of 2024, due to an increase in the Company's share of profits from the commercialization of antibodies, which were $1.282 billion and $988 million in the second quarter of 2025 and 2024, respectively. The change in the Company's share of profits from commercialization of antibodies was driven by higher profits associated with an increase in Dupixent sales.

Refer to Table 4 for a summary of collaboration revenue.

Other revenue increased in the second quarter of 2025, compared to the second quarter of 2024, due to an increase in royalties and share of profits earned in connection with license agreements, which were $118 million and $69 million for the second quarter of 2025 and 2024, respectively.

Operating Expenses

		GAAP								% Change				Non-GAAP(a)								% Change
($ in millions)		Q2 2025				Q2 2024								Q2 2025				Q2 2024
Research and development (R&D)		$	1,422			$	1,200				19%			$	1,283			$	1,072				20%
Acquired in-process research and
development (IPR&D)		$	10			$	24				(58%)				*				*				n/a
Selling, general, and administrative
(SG&A)		$	634			$	759				(16%)			$	542			$	667				(19%)
Cost of goods sold (COGS)		$	276			$	258				7%			$	222			$	214				4%
Gross margin on net product sales(c)			83%				87%								86%				89%
Cost of collaboration and contract
manufacturing (COCM)(d)		$	255			$	222				15%				*				*				n/a
Other operating expense (income), net		$	—			$	15				(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 second quarter of 2025, compared to the second quarter of 2024, driven by the advancement of the Company's mid- and late-stage clinical pipeline.
• GAAP and non-GAAP SG&A expenses decreased in the second quarter of 2025, compared to the second quarter of 2024, primarily due to lower charitable contributions to an independent not-for-profit patient assistance organization.
• GAAP and non-GAAP gross margin on net product sales decreased in the second quarter of 2025, compared to the second quarter of 2024, partly due to ongoing investments to support the Company's manufacturing operations and higher inventory write-offs and reserves in the second quarter of 2025 compared to the second quarter of 2024.

Other Financial Information

GAAP other income (expense), net included the recognition of net unrealized gains on equity securities of $250 million in the second quarter of 2025, compared to $393 million in the second quarter of 2024.

In the second quarter of 2025, the Company's GAAP effective tax rate (ETR) was 8.4%, compared to 12.0% in the second quarter of 2024. The GAAP ETR decreased in the second quarter of 2025, compared to the second quarter of 2024, primarily due to the net change in uncertain tax positions, partly offset by lower tax benefits from less stock option exercises. During the second quarter of 2025, the release of liabilities for uncertain tax positions recognized upon the effective settlement of an IRS audit reduced the Company's GAAP ETR by 3.9%. In the second quarter of 2025, the non-GAAP ETR was 8.3%, compared to 10.8% in the second quarter of 2024.

A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release.

Capital Allocation

During the second quarter of 2025, the Company repurchased shares of its common stock and recorded the cost of the shares, or $1.070 billion, as Treasury Stock. As of June 30, 2025, $2.814 billion remained available for share repurchases under the Company's share repurchase programs.

In July 2025, the Company's board of directors declared a cash dividend of $0.88 per share on the Company's common stock and Class A stock, payable on September 3, 2025 to shareholders of record as of August 18, 2025.

2025 Financial Guidance(b)

The Company's full year 2025 financial guidance consists of the following components:

		2025 Guidance
		Prior		Updated
GAAP R&D		$5.560–$5.795 billion		$5.660–$5.790 billion
Non-GAAP R&D(a)		$5.000–$5.200 billion		$5.100–$5.200 billion
GAAP SG&A		$2.910–$3.095 billion		$2.810–$2.940 billion
Non-GAAP SG&A(a)		$2.550–$2.700 billion		$2.450–$2.550 billion
GAAP gross margin on net product sales		83%–84%		Approximately 83%
Non-GAAP gross margin on net product sales(a)		86%–87%		Approximately 86%
COCM*		$1.000–$1.150 billion		$1.000–$1.050 billion
Capital expenditures*		$850–$950 million		$880–$950 million
GAAP effective tax rate		9%–11%		11%–13%
Non-GAAP effective tax rate(a)		11%–13%		Unchanged
* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been or are expected to be recorded

A reconciliation of full year 2025 GAAP to non-GAAP financial guidance is included below:

		Projected Range
($ in millions)		Low				High
GAAP R&D		$	5,660			$	5,790
Stock-based compensation expense			560				590
Non-GAAP R&D		$	5,100			$	5,200
GAAP SG&A		$	2,810			$	2,940
Stock-based compensation expense			360				390
Non-GAAP SG&A		$	2,450			$	2,550
GAAP gross margin on net product sales			83%				83%
Intangible asset amortization expense			2%				2%
Stock-based compensation expense			1%				1%
Non-GAAP gross margin on net product sales			86%				86%
GAAP ETR			11%				13%
Income tax effect of GAAP to non-GAAP
reconciling items