Regeneron's Q3 2024: Dupixent Drives Growth, COPD Approval, and Pipeline Advances
核心洞察
Regeneron reported an 11% increase in revenue to $3.72 billion for Q3 2024, driven by strong performance of key products like Dupixent and EYLEA HD (搜索).
Dupixent global net sales, recorded by Sanofi, surged by 23% to $3.82 billion, bolstered by recent FDA approval for treating COPD (搜索) with an eosinophilic phenotype.
The company's pipeline progresses with positive trial results for Dupixent in chronic spontaneous urticaria and bullous pemphigoid, supporting regulatory submissions.
Regeneron Pharmaceuticals announced strong financial results for the third quarter of 2024, marked by an 11% increase in revenue, reaching $3.72 billion compared to Q3 2023. The growth was primarily fueled by its key products, including Dupixent, EYLEA HD (搜索), and Libtayo. The company also highlighted significant pipeline advancements and regulatory milestones.
Financial Performance
Total revenues reached $3.72 billion, an 11% increase compared to the third quarter of 2023. Dupixent global net sales, recorded by Sanofi, increased 23% to $3.82 billion. U.S. net sales for EYLEA HD (搜索) and EYLEA increased 3% to $1.54 billion, including $392 million from EYLEA HD. Libtayo global net sales increased 24% to $289 million. GAAP diluted EPS increased 30% to $11.54, while non-GAAP diluted EPS increased 8% to $12.46.
"Regeneron had a strong third quarter marked by 11% revenue growth. We continued to deepen the impact of our commercialized medicines this quarter, with ongoing leadership for our retinal franchise, expanded global reach of Libtayo, and notable growth from Dupixent," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron.
Dupixent Expansion
A significant highlight was the FDA approval of Dupixent (dupilumab) as the first biologic therapy in the U.S. for the treatment of inadequately controlled chronic obstructive pulmonary disease (COPD (搜索)) with an eosinophilic phenotype. This approval marks a significant advancement in COPD treatment, providing a new option for patients with this specific disease profile. The company and Sanofi also reported positive results from pivotal trials of Dupixent in chronic spontaneous urticaria (CSU) and bullous pemphigoid (BP). A supplemental Biologics License Application (sBLA) for CSU has been resubmitted, and a sBLA submission for BP is planned for the fourth quarter of 2024.
EYLEA HD Updates
Regeneron announced positive three-year (156-week) data from an extension study of the Phase 3 PHOTON trial in patients with diabetic macular edema (搜索) (DME (搜索)). The data demonstrated that the majority of EYLEA HD (搜索) patients sustained visual gains and anatomic improvements achieved by the end of the second year. Notably, 48% of EYLEA HD patients who completed the full 156 weeks of treatment were assigned a dosing interval of ≥20 weeks at the end of the third year. These results were presented at the American Academy of Ophthalmology (AAO) Annual Meeting.
Oncology Pipeline
In August 2024, the European Commission (EC) approved Ordspono (odronextamab) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (搜索) (FL (搜索)) or R/R diffuse large B-cell lymphoma (搜索) (DLBCL (搜索)) after two or more lines of systemic therapy. The company also presented five-year results from the final pre-specified overall survival (OS) analysis of a Phase 3 trial evaluating Libtayo (cemiplimab) monotherapy versus chemotherapy as a first-line treatment for certain adults with advanced non-small cell lung cancer (搜索) (NSCLC (搜索)) with ≥50% PD-L1 (搜索) expression. A Phase 2 study for Libtayo in neoadjuvant NSCLC was initiated.
Other Pipeline Developments
Regeneron is also advancing its pipeline with other programs, including a Phase 3 study for pozelimab in combination with cemdisiran in geographic atrophy and a Phase 2 study for REGN7999 in beta-thalassemia.
"Our remarkably diverse clinical portfolio now includes approximately 40 product candidates and many pivotal studies underway. We continue to invest in the world-class research and development engine that drives our scientific and clinical productivity, with data expected over the next twelve months in diseases as varied as non-small cell lung cancer (搜索), thrombosis, retinal vein occlusion, severe allergy, COPD (搜索), melanoma, and obesity," added Dr. Schleifer.
Financial Guidance
Regeneron updated its full-year 2024 financial guidance, reflecting confidence in its continued growth and pipeline progress. The company's GAAP R&D expenses are now projected to be between $5.055 and $5.145 billion, while non-GAAP R&D expenses are expected to range from $4.525 to $4.575 billion.