Regeneron Pharmaceuticals reports Q3 2026 results.

Item 2.02 Results of Operations and Financial Condition.

On October 30, 2026, Regeneron Pharmaceuticals, Inc. issued a press release announcing its financial and operating results for the quarter ended September 30, 2026.¹ A copy of the press release is being furnished to the Securities and Exchange Commission as Exhibit 99.1² to this Current Report on Form 8-K and is incorporated by reference to this Item 2.02.

The information included or incorporated in this Item 2.02, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934², as amended, nor shall such information and exhibit be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

99.1 Press Release, dated October 30, 2026, Reporting Third Quarter 2026 Financial and Operating Results.³

104 Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document.⁴

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: October 30, 2026

REGENERON PHARMACEUTICALS, INC.

By: /s/ Joseph J. LaRosa⁵

Name: Joseph J. LaRosa⁵

Title: Executive Vice President, General Counsel and Secretary⁵

Press Release

Regeneron Reports Third Quarter 2026 Financial and Operating Results

• Third quarter 2026 revenues increased 36% to $5.1 billion versus third quarter 2025

• Dupixent ® global net sales (recorded by Sanofi) increased 35% to $6.5 billion⁹

• EYLEA HD ® U.S. net sales increased 62% to $699 million¹⁰

• Libtayo ® global net sales increased 51% to $550 million¹⁰

• Pasatru ™ (garetosmab) approved by FDA for fibrodysplasia ossificans progressiva (FOP)

Tarrytown, New York (October 30, 2026) -- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN ) today announced financial results for the third quarter of 2026 and provided a business update.

"This was an outstanding quarter for Regeneron, with Dupixent, EYLEA HD, and Libtayo each achieving record net sales," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "Our pipeline of about 50 product candidates is rapidly advancing. We expect an FDA decision for cemdisiran in generalized myasthenia gravis next month; our Phase 3 programs in multiple myeloma, lymphoma, anticoagulation, and obesity continue to advance; and we have generated encouraging early data in MASH, POTS, and ovarian cancer. Finally, we expanded our alliance with Sanofi to include four Regeneron-invented, next-generation, long-acting antibodies designed to build on the success of Dupixent."

Financial Highlights

Non-GAAP net income (a)

$ 2,150 $ 1,287 67 %

Non-GAAP net income per share - diluted (a)⁸

$ 20.07 $ 11.83 70 %⁸

"We are pleased with our third quarter financial results, which marked our third consecutive quarter of double-digit growth in both revenue and non-GAAP EPS," said Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "Strong commercial execution across our portfolio, together with the anticipated step-up in Sanofi collaboration revenue in the first full quarter following repayment of the Development Balance, drove a 36% increase in total revenues and a 70% increase in non-GAAP EPS, positioning us to deliver one of our strongest years ever."

1

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:

Libtayo (cemiplimab)

• In August 2026, the Ministry of Health, Labour and Welfare (MHLW) in Japan approved Libtayo as an adjuvant treatment for cutaneous squamous cell carcinoma (CSCC) and for the treatment of metastatic or locally advanced CSCC. These indications are already approved in the United States and European Union (EU).

• In October 2026, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of an alternative dosing schedule for Libtayo across all approved indications. The positive opinion supports reducing Libtayo dosing frequency from every three weeks to every six weeks after the first 12 weeks of treatment. The European Commission (EC) is expected to make a final decision in the coming months. There is also a supplemental Biologics License Application (sBLA) under review by the U.S. Food and Drug Administration (FDA), which has a target action date in March 2027.

• In October 2026, the Company announced longer-term data which showed increasing and clinically meaningful overall survival benefit for Libtayo as an adjuvant treatment for patients with CSCC. The results were presented at the European Society for Medical Oncology (ESMO) 2026 Meeting.

Other Oncology Programs

• The FDA accepted for review the resubmission of the BLA for Ordspono ™ (odronextamab) in relapsed or refractory diffuse large B-cell lymphoma (DLBCL), which has a target action date in February 2027.

• The Company announced that ubamatamab (MUC16 and CD3 bispecific antibody) showed a high rate of durable responses in an initial study in patients with advanced low-grade serous ovarian cancer (LGSOC). The data are from an ongoing Phase 1/2 trial and were presented at the International Gynecologic Cancer Society (IGCS) 2026 Annual Global Meeting. Based on these preliminary trial results, the Company has been enrolling a single-arm, potentially registrational LGSOC trial and is planning to initiate a confirmatory Phase 3 trial in this setting.

Pasatru (garetosmab)

• In August 2026, the FDA approved Pasatru to reduce formation of new heterotopic ossification lesions and clinician-assessed flare-ups in adults with FOP. A regulatory application is also under review in the EU.

• The Company announced positive 84-week results from the Phase 3 trial for Pasatru in adults with FOP. These longer-term findings demons