Regeneron Q1 2024 Financial and Operating Results

Regeneron Pharmaceuticals Inc. reported its financial results for the first quarter of 2024, showcasing various achievements and developments across its product lines and pipeline. Despite a slight overall decline in revenues compared to the first quarter of 2023, the company's financial performance remains robust, with significant growth in key areas.

In Q1 2024, Regeneron registered total revenues of $3.15 billion, a 1% decrease from the same period in the previous year. However, when excluding the impact of Ronapreve, revenues actually increased by 7%. The company reported a GAAP diluted earnings per share (EPS) of $6.27 and a non-GAAP diluted EPS of $9.55.

One of the standout performers for the quarter was Dupixent®, which saw its global net sales climb 24% to $3.08 billion, reflecting its strong market presence and growing demand. In the U.S., net sales for EYLEA® HD and EYLEA® amounted to $1.40 billion, which included $200 million from EYLEA HD. Libtayo® also demonstrated impressive growth, with its global net sales increasing by 45% to reach $264 million.

Regeneron's CEO, Leonard S. Schleifer, highlighted the company's ongoing commitment to delivering approved medicines to a broader patient base worldwide and advancing its pipeline of clinical-stage programs. Schleifer noted the promising uptake of EYLEA HD and the continued remarkable growth of Dupixent, which now treats over 850,000 patients across various type 2 inflammation-related diseases. The oncology franchise, particularly Libtayo, showed significant global sales growth, and potential regulatory approvals for linvoseltamab in relapsed/refractory multiple myeloma are anticipated later in the year.

From a financial perspective, the company authorized a new $3.0 billion share repurchase program in April 2024, providing additional flexibility for returning capital to shareholders while continuing to invest in innovation.

Key updates from the clinical pipeline include approvals and regulatory advancements for multiple products. EYLEA HD (aflibercept) 8 mg received approvals from the European Commission and Japan's Ministry of Health, Labour, and Welfare for treating wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). The U.S. Centers for Medicare & Medicaid Services assigned a permanent J-code for EYLEA HD, effective April 2024, simplifying the billing and reimbursement process.

Dupixent (dupilumab) saw its supplemental Biologics License Application accepted for priority review by the FDA for use in adult patients with uncontrolled chronic obstructive pulmonary disease (COPD) and type 2 inflammation. Furthermore, a Phase 3 study for Dupixent in children aged 2 to 5 years with asthma was initiated, and Japan approved Dupixent for chronic spontaneous urticaria (CSU) in patients aged 12 and older.

In oncology, the FDA accepted the Biologics License Application (BLA) for linvoseltamab for treating relapsed/refractory multiple myeloma, with a target action date set for August 22, 2024. Positive data from the Phase 1/2 trial of linvoseltamab were presented at the American Association for Cancer Research Annual Meeting, reinforcing its efficacy with a 71% objective response rate.

Other notable developments include the FDA extending the approval of Praluent® (alirocumab) to include pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia. Additionally, a Phase 2 study for itepekimab in non-cystic fibrosis bronchiectasis and another for ALN-APP in cerebral amyloid angiopathy were initiated.

Regeneron also made strategic corporate moves by acquiring full development and commercialization rights to 2seventy bio's oncology and autoimmune preclinical and clinical-stage cell therapy pipeline. Furthermore, a collaboration with Mammoth Biosciences to develop CRISPR-based gene editing therapies was established.

While Q1 2024 saw decreased net product sales for EYLEA in the U.S. due to changing market dynamics and a reduction in wholesaler inventory, the total net product sales increased by 6% to $1.76 billion, driven by strong performances from products like Libtayo and Praluent.

Regeneron's continued focus on advancing its pipeline, strategic acquisitions, and collaborations aim to sustain its growth trajectory and enhance its position as a leader in the biotechnology industry.