Detailed Narrative
EYLEA and EYLEA HD Performance and Challenges
EYLEA U.S. net sales declined significantly to $736 million, down 39% YoY and 38% QoQ, due to lower wholesale inventory, competitive pressures, and increased use of low-cost off-label Avastin. This shift was driven by patient affordability issues and a funding gap at co-pay assistance foundations. EYLEA HD showed strong year-over-year growth of 54% to $307 million but was flat sequentially, also impacted by inventory adjustments. Combined, EYLEA and EYLEA HD captured 41% of the anti-VEGF category, maintaining market leadership despite these headwinds.
Regulatory Setback for EYLEA HD Pre-filled Syringe
The FDA issued a Complete Response Letter (CRL) for the EYLEA HD pre-filled syringe, primarily due to a question posed to a third-party component supplier regarding a drug master file. Management believes the issue is resolvable and does not relate to safety, efficacy, usability, labeling, or inspection findings, noting the same device is approved and safely used in Europe. The company is engaging with the FDA and the supplier to expedite resolution, though the timeline remains uncertain.
Dupixent's Continued Growth and New Indications
Dupixent demonstrated robust global sales growth of 20% (constant currency) to $3.7 billion, driven by strong demand across approved indications and geographic regions. It achieved its seventh FDA approval for chronic spontaneous urticaria (CSU) and became the first biologic approved for COPD in Japan. The U.S. COPD launch is gaining momentum with increasing prescriber appreciation and favorable payer coverage, outperforming all other Dupixent indication launches in cumulative new-to-brand prescriptions, except atopic dermatitis.
Libtayo's Expanding Market Share
Libtayo continued to grow, with global net sales up 8% (constant currency) to $285 million and U.S. sales up 21% to $193 million. It has established itself as a cornerstone therapy for advanced non-melanoma skin cancer and is increasing its share in the lung cancer market. Libtayo is now second in new-to-brand prescription share in first-line advanced non-small cell lung cancer, reflecting its differentiated clinical profile and commercial strategy.
Oncology Pipeline Advancements
Regeneron's oncology pipeline saw significant progress with conditional marketing authorization for linvoseltamab in Europe and accepted BLA resubmissions for linvoseltamab (multiple myeloma) and odronextamab (follicular lymphoma) in the U.S., both with PDUFA dates in July. Data for Libtayo in adjuvant CSCC, showing a 68% reduction in recurrence risk, will be presented at ASCO. A Phase III trial for Libtayo + fianlimab in metastatic melanoma is expected to read out in H2 2025, with early data suggesting substantial additive benefit.
Broader Pipeline Progress
Beyond oncology, the company is advancing its Factor XI program, with pivotal studies enrolling this year, investigating two different antibodies for improved blood clot prevention and lower bleeding risk. The Phase II COURAGE study for trevogrumab in obesity, aiming to improve weight loss quality by maintaining muscle mass, is expected to report data in H2 2025. Pivotal results for the C5 siRNA/antibody combination in generalized myasthenia gravis are also anticipated in H2 2025, building on strong C5 inhibition data in PNH.
Strategic Investments and Capital Allocation
Regeneron announced over $7 billion in planned U.S. investments to expand R&D and manufacturing capacity, including a new $3 billion agreement with FUJIFILM Diosynth Biotechnologies and a $3.6 billion expansion of its Tarrytown facilities. These investments aim to support U.S. growth and manufacturing capabilities. The company also returned capital to shareholders, repurchasing $1.1 billion worth of shares in Q1 and initiating a quarterly dividend of $0.88 per share.