Regeneron Announces Q3 2024 Financial and Operating Results

In the third quarter of 2024, Regeneron Pharmaceuticals, Inc. reported a robust financial performance, showcasing significant growth in revenues and net income. The company's total revenues rose by 11% compared to the same period in 2023, reaching $3.72 billion. This growth was primarily driven by the impressive performance of key products such as Dupixent®, EYLEA HD®, EYLEA®, and Libtayo®.

Dupixent® achieved a remarkable 23% increase in global net sales, totaling $3.82 billion. This continued success underscores the drug's widespread acceptance and efficacy in treating various conditions. EYLEA HD® and EYLEA® saw a combined 3% increase in U.S. net sales, amounting to $1.54 billion. Notably, EYLEA HD® contributed $392 million to this total, reflecting its growing adoption since its FDA approval in August 2023. Libtayo® also demonstrated strong growth, with global net sales rising by 24% to $289 million.

The company's financial performance was also marked by significant improvements in earnings per share (EPS). The GAAP diluted EPS increased by 30% to $11.54, while the non-GAAP diluted EPS saw an 8% rise to $12.46. However, the third quarter included a minor unfavorable impact of $0.43 due to an acquired in-process research and development (IPR&D) charge.

Regeneron's CEO, Leonard S. Schleifer, highlighted the company's strong performance and continued investment in its diverse clinical portfolio, which now includes approximately 40 product candidates. The company is conducting pivotal studies across various therapeutic areas, including non-small cell lung cancer, thrombosis, severe allergies, and obesity. Schleifer emphasized the significant global reach and impact of Dupixent®, which now treats over one million patients worldwide.

The third quarter also saw several key developments in Regeneron's pipeline. The FDA approved Dupixent® as the first biologic therapy in the U.S. for treating inadequately controlled chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. Positive results were reported for Dupixent® pivotal trials in chronic spontaneous urticaria (CSU) and bullous pemphigoid (BP), with regulatory submissions planned for the fourth quarter of 2024.

In the oncology sector, Regeneron made significant strides with Libtayo®. The company announced five-year results from a Phase 3 trial, which highlighted Libtayo's efficacy as a first-line treatment for advanced non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression. These results were presented at the IASLC 2024 World Conference on Lung Cancer. Additionally, the European Commission approved Ordspono™ (odronextamab) for treating relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma.

Financially, Regeneron’s operating expenses increased due to ongoing investments in research and development, as well as higher costs associated with the commercialization of new products like EYLEA HD®. The company's research and development expenses rose by 18% to $1.27 billion, driven by the advancement of its clinical pipeline and higher staffing costs. Selling, general, and administrative expenses also saw an 11% increase, reflecting the expenses related to product launches and international expansion.

The company’s collaboration with Sanofi continued to be a significant revenue driver, with collaboration revenue increasing by 19% to $1.26 billion. This growth was attributed to the higher profits from the commercialization of antibodies, primarily driven by the increase in Dupixent® sales.

Regeneron’s financial guidance for the full year 2024 reflects its ongoing commitment to research and development. The company expects to invest between $5.055 billion and $5.145 billion in GAAP R&D, with non-GAAP R&D expenses projected to range between $4.525 billion and $4.575 billion. Additionally, GAAP SG&A expenses are anticipated to be between $2.93 billion and $3.02 billion, while non-GAAP SG&A expenses are expected to range from $2.55 billion to $2.6 billion.

Overall, Regeneron's third quarter of 2024 was marked by strong financial performance, significant advancements in its clinical pipeline, and continued investment in research and development to drive future growth. The company remains focused on translating scientific discoveries into innovative treatments that address unmet medical needs and improve patient outcomes worldwide.