• Thirdquarter 2023 revenues increased 15% to $3.36 billion versus third quarter 2022
• Third quarter 2023 Dupixent®global net sales(recorded by Sanofi) increased 33% to $3.10 billion versus third quarter 2022
• Third quarter 2023 U.S. net sales for EYLEA®and EYLEA HD were $1.49 billion, including $43 million from EYLEA HD
• Third quarter 2023 Libtayo®global net sales increased 62% to $232 million versus third quarter 2022
• Third quarter 2023 GAAP diluted EPS of $8.89 and non-GAAP diluted EPS(a)of $11.59; includes unfavorable $0.77 impact from acquired IPR&D charge
• FDA approved EYLEA HD for wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR) and Veopoz™for CHAPLE disease
• Two-year results reported for EYLEA HD from pivotal PULSAR trial demonstrated durable vision gains at extended dosing intervals in wAMD
• FDA accepted for priority review BLA for odronextamab for follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) and sBLA for Dupixent in eosinophilic esophagitis (EoE) in children aged 1 to 11 years of age
• Acquisition of Decibel Therapeutics completed, strengthening genetic medicines portfolio

TARRYTOWN, N.Y., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) today announced financial results for the third quarter of 2023 and provided a business update.

"We have continued our momentum in the third quarter of 2023 with double-digit year-over-year revenue growth, driven by strong Dupixent and Libtayo performance, as well as strong initial uptake of EYLEA HD following its late August launch," said Leonard S. Schleifer, M.D., Ph.D., Board Co-Chair, President and Chief Executive Officer of Regeneron. "We are also making significant progress across our diversified pipeline, with FDA priority review designations for odronextamab in relapsed/refractory (R/R) follicular lymphoma and R/R diffuse large B-cell lymphoma as well as for Dupixent in pediatric eosinophilic esophagitis, while also adding a promising gene therapy platform to our portfolio through the recent acquisition of Decibel Therapeutics."

"Our third quarter financial results reflect robust execution across the enterprise, including notable pipeline advances and strong commercial performance," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "We also continued to deliver on our capital allocation priorities, primarily investing in internal and external innovation coupled with opportunistic share repurchases."

Business Highlights

Key Pipeline ProgressRegeneron has approximately 35 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:

EYLEA HD (aflibercept) 8 mg

• In August 2023, the U.S. Food and Drug Administration (FDA) approved EYLEA HD for the treatment of patients with wAMD, DME, and DR.
• The Company announced top-line, two-year (96 weeks) data from the pivotal PULSAR trial in patients with wAMD. The longer-term data follow the positive two-year results from the PHOTON trial in DME, with PULSAR similarly demonstrating that the vast majority of patients with wAMD were able to maintain or further extend the dosing intervals. In addition, visual gains for EYLEA HD remained largely consistent with those observed in the first year of the trial. In PULSAR, the safety of EYLEA HD continued to be similar to EYLEA through two years and remained consistent with the known safety profile of EYLEA from previous clinical trials for wAMD. These results were also presented at the 23rd EURETINA Congress in October 2023.

Dupixent (dupilumab)

• In September 2023, the Ministry of Health, Labour and Welfare (MHLW) in Japan approved Dupixent for the treatment of pediatric and adolescent patients with atopic dermatitis.
• The FDA accepted for priority review the supplemental Biologics License Application (sBLA) for the treatment of children aged 1 to 11 years with EoE, with a target action date of January 31, 2024. The Company and Sanofi also presented, at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting, positive results from a Phase 3 trial that showed consistent efficacy and safety for up to one year (52 weeks) in children aged 1 to 11 years with EoE.
• In October 2023, the FDA issued a Complete Response Letter (CRL) for the sBLA for Dupixent in chronic spontaneous urticaria (CSU). The CRL states that additional efficacy data are required to support an approval; it did not identify any issues with safety or manufacturing. An ongoing Phase 3 clinical trial (in biologic-naïve patients) continues to enroll patients, with results expected in late 2024.
• Based on recent feedback from the FDA, in addition to the positive results of the Phase 3 BOREAS study, a positive interim analysis of the replicate Phase 3 NOTUS study in chronic obstructive pulmonary disease (COPD) would enable an sBLA submission. The independent data monitoring committee will conduct an interim analysis of the NOTUS study later this year.

Oncology Programs

• In September 2023, the FDA accepted for priority review the BLA for odronextamab, a bispecific antibody targeting CD20 and CD3, to treat adult patients with relapsed/refractory FL and relapsed/refractory DLBCL who have progressed after at least two prior systemic therapies, with a target action date of March 31, 2024. A regulatory application for odronextamab has also been submitted in the European Union (EU).
• Phase 3 studies were initiated for odronextamab in earlier lines of FL and DLBCL.
• The FDA granted Fast Track designation to fianlimab, an antibody to LAG-3, in combination with Libtayo (cemiplimab) for the first-line treatment of patients with metastatic melanoma (for which a Phase 3 study is ongoing).
• A Phase 3 study was initiated for linvoseltamab, a bispecific antibody targeting BCMA and CD3, in multiple myeloma.
• The Company presented key secondary endpoints, demonstrating encouraging event-free survival, from a Phase 2 trial with Libtayo as a neoadjuvant monotherapy in cutaneous squamous cell carcinoma (CSCC) at the European Society for Medical Oncology (ESMO) Congress 2023. These results were also concurrently published in The Lancet Oncology.

Other Programs

• The FDA approved Veopoz (pozelimab-bbfg), an antibody to C5, for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy. CHAPLE is an ultra-rare hereditary disease that can cause potentially life-threatening gastrointestinal and cardiovascular symptoms.
• The Company announced preliminary, positive safety and efficacy results from the first patient (