Regeneron Announces Q2 2024 Financial and Operating Results

Regeneron Pharmaceuticals, Inc., based in Tarrytown, N.Y., recently reported its financial outcomes for the second quarter of 2024, reflecting a robust performance across several key pharmaceutical products. The company's overall revenue surged by 12% year-over-year to $3.55 billion, driven by significant growth in the sales of its drugs EYLEA HD, Dupixent, and Libtayo.

For the quarter, the global net sales of Dupixent reached $3.56 billion, marking a 27% increase from the same period in 2023. This drug, which is recorded by Sanofi, received its first regulatory approval for treating chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils from the European Commission. The U.S. market sales for EYLEA and EYLEA HD collectively grew by 2%, totaling $1.53 billion, with EYLEA HD alone contributing $304 million to this figure. Libtayo continued its growth trajectory with global net sales up by 42% to $297 million compared to the second quarter of the previous year.

The financial metrics for the company also showed strong growth. The GAAP diluted earnings per share (EPS) climbed by 46% to $12.41, while the non-GAAP diluted EPS saw a 13% rise to $11.56, despite an unfavorable $0.18 impact due to an acquired in-process research and development (IPR&D) charge.

In the words of Leonard S. Schleifer, M.D., Ph.D., President and CEO of Regeneron, “Regeneron had a strong quarter, with total revenue up 12%, driven by notable growth for EYLEA HD, Dupixent, and Libtayo. Importantly, Dupixent was granted its first regulatory approval for COPD by the European Commission, with FDA action anticipated in the third quarter, presenting an opportunity to help even more patients around the globe.”

Christopher Fenimore, Senior Vice President of Finance and CFO of Regeneron, highlighted the company's strategic focus on advancing its pipeline, emphasizing the continued commercial success and prudent capital deployment aimed at long-term value creation.

Regeneron is progressing with over 35 product candidates in clinical development. Significant updates from their clinical pipeline include:

- EYLEA HD (aflibercept) 8 mg: A supplemental Biologics License Application (sBLA) with two-year data for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) has been submitted to the FDA.
- Dupixent (dupilumab): The FDA extended the review period for Dupixent as an add-on maintenance treatment for certain adult patients with uncontrolled COPD by three months, with a revised action date of September 27, 2024. Additionally, the European Commission approved Dupixent for COPD characterized by raised blood eosinophils, making it the first biologic therapy approved for this indication.
- Oncology programs: The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending conditional marketing authorization of odronextamab for adults with relapsed/refractory follicular lymphoma or diffuse large B-cell lymphoma after two or more lines of systemic therapy. The company also presented promising 14-month median follow-up data for linvoseltamab in relapsed/refractory multiple myeloma.

Other notable advancements include the FDA's approval of Kevzara for treating active polyarticular juvenile idiopathic arthritis and the initiation of a Phase 2 study in obesity for trevogrumab in combination with semaglutide.

Financially, Regeneron observed a notable increase in revenue and operational efficiency. The company’s operating expenses saw a rise due to expanded commercialization activities and higher research and development costs associated with late-stage oncology programs. GAAP and Non-GAAP R&D expenses climbed by 11% and 10%, respectively, driven by ongoing advancements in their clinical pipeline.

Additionally, various strategic financial decisions were made, including a new share repurchase program authorized by the board to buy back up to $3.0 billion of the company's common stock. By the end of June 2024, Regeneron had repurchased $601 million worth of shares, leaving an aggregate of $3.6 billion available for further repurchases. The company's total assets reached $36.1 billion by the end of the second quarter, up from $33.1 billion at the end of 2023.

Overall, Regeneron’s second-quarter results for 2024 highlight significant growth in revenue, promising advancements in their clinical pipeline, and strategic initiatives aimed at sustaining long-term growth and innovation in the biopharmaceutical sector.

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