Regeneron Pharmaceuticals (REGN) investor relations material

Commercial performance and product updates

• EYLEA HD saw strong sequential demand growth in Q1 and Q2, driven by effective commercial execution and education efforts targeting both physicians and patients.

• Key upcoming regulatory milestones include a PDUFA date in late October for the prefilled syringe and another in late November for RVO and Q4 dosing sBLA, with confidence in timely resolution of manufacturing issues.

• Biosimilar competition for EYLEA 2mg has led to gradual market uptake, with additional entrants expected in late 2026, potentially increasing pricing pressure.

• DUPIXENT continues to perform strongly across eight approved indications, with growth driven by established and new launches, particularly in COPD.

• Investments in COPD launch leverage existing pulmonary field teams, with high early adoption among top pulmonologists and a focus on both physician and patient education.

Pipeline and R&D strategy

• Strategic ambition is to develop a basket of opportunities, including longer-acting DUPIXENTs and novel inflammatory targets, to sustain growth beyond DUPIXENT’s exclusivity in 2031.

• Oncology pipeline features recent approvals for bispecifics, with early Linezyth launch feedback positive and plans to expand into earlier lines and precursor conditions.

• Upcoming studies include combinations in second line plus myeloma and trials in newly diagnosed and smoldering myeloma, with promising early data in precursor conditions.

• LAG-3 combination trials in melanoma aim to outperform current standards, with key readouts expected and a head-to-head study against Opdualag maturing by 2027.

• Complement and Factor XI programs show promise in MG, PNH, geographic atrophy, and anticoagulation, with multiple phase 2 and 3 studies underway and initial data expected in 2027.

Obesity and metabolic programs

• Muscle-sparing agents combined with GLP-1 therapies demonstrated significant preservation of lean mass during weight loss, with ongoing studies to assess long-term effects.

• Licensed GLP-1/GIP asset olorepatide will be developed as a monotherapy and in combination, with a phase 3 program planned for next year.