REGENERON PHARMACEUTICALS, INC. (REGN) Risk Factors

Recent key developments

Concrete developments — dated events, named agreements and instruments, legal proceedings — that REGENERON PHARMACEUTICALS, INC. surfaced in its latest filing.

• EYLEA HD and EYLEA U.S. net product sales represented 25% and 33% of total revenues for the six months ended June 30, 2026 and 2025, respectively. For the three and six months ended June 30, 2026, EYLEA U.S. net product sales declined by 45% and 41%, respectively, compared to the same periods in 2025.June 30, 2026
• Several biosimilar versions of EYLEA have been approved by the FDA following the May 2024 expiration of U.S. regulatory exclusivity, and one such product has launched in the United States. Additional biosimilar versions are expected to launch in the near future.May 2024
• Amgen's Pavblu (aflibercept-ayyh), a biosimilar version of EYLEA, approved and launched in the United States.
• FDA recently approved EYLEA HD for treatment of RVO and for additional dosing regimens, and the company is working toward FDA approval of the EYLEA HD pre-filled syringe.
• For the six months ended June 30, 2026 and 2025, Sanofi collaboration revenue (most of which is attributable to the company's share of profits from commercialization of Dupixent) represented 48% and 39% of total revenues, respectively.June 30, 2026
• In April 2026, Regeneron entered into the U.S. Government Agreements to provide certain wholly owned U.S. products to Medicaid and to price certain future U.S. medicines at no greater than Most-Favored-Nation Pricing. The agreements exempt Regeneron's products from Section 232 tariffs through January 2029.April 2026
• Medicare Drug Price Negotiation Program requires the government to set prices for select high-expenditure drugs covered under Medicare Parts B and D, with established prices for the first cycle of selected Part D drugs effective at the beginning of 2026 and selected Part B drugs effective in 2028.2026
• In October 2025, FDA issued a Complete Response Letter for the regulatory application for the EYLEA HD pre-filled syringe due to third-party manufacturer inspection findings.October 2025
• FDA issued a Complete Response Letter in October 2023 for the sBLA for Dupixent in chronic spontaneous urticaria requiring additional efficacy data, delaying approval by nearly 18 months until April 2025.October 2023
• In March 2024, FDA issued Complete Response Letters for the BLA for odronextamab in relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma due to enrollment status of confirmatory Phase 3 trials.March 2024
• In July 2025, FDA issued a Complete Response Letter for the BLA for odronextamab in relapsed/refractory follicular lymphoma due to findings from inspections at third-party manufacturers responsible for filling drug product.July 2025
• Phase 3 trial of fianlimab in combination with Libtayo in first-line metastatic melanoma did not reach statistical significance for its primary endpoint compared to pembrolizumab monotherapy (announced May 2026).May 2026
• In March 2026, the USPTO instituted a post-grant review of U.S. Patent No. 12,168,036 relating to EYLEA HD.March 2026
• In 2018, we and Sanofi entered into a license agreement with Bristol-Myers Squibb, E. R. Squibb & Sons, and Ono Pharmaceutical for rights to develop and sell Libtayo.2018
• Completed acquisition of Checkmate Pharmaceuticals, Inc. in May 2022.May 2022
• Completed acquisition of Decibel Therapeutics, Inc. in September 2023.September 2023
• In April 2024, acquired full development and commercialization rights to 2seventy bio, Inc.'s oncology and autoimmune preclinical and clinical stage cell therapy pipeline.April 2024
• As of June 30, 2026, we had an aggregate of $2.707 billion of outstanding indebtedness under our senior unsecured notes and the lease financing facility.June 30, 2026
• In July 2026, a putative class action civil complaint was filed against the Company alleging violations of federal securities laws.July 2026
• April 2026 board authorization of a share repurchase program of up to $3.0 billion.April 2026
• Quarterly cash dividend program initiated by the board in 2025.2025
• During Q1–Q2 2026, bulk manufacturing production at the Limerick, Ireland facility was temporarily interrupted due to unanticipated facility repairs.Q1–Q2 2026
• Antibody Collaboration Litigation alleges breach of provisions concerning Sanofi's obligation to provide full access to material information relating to commercialization of Dupixent and Regeneron's audit rights.
• The BIOSECURE Act, enacted into law in late 2025, could restrict engagement of China-based suppliers or service providers.late 2025