Introduction & Market Context
Regeneron Pharmaceuticals Inc (NASDAQ:REGN) released its Q1 2025 corporate presentation on April 29, 2025, highlighting continued growth of its flagship products amid evolving market dynamics. The biotech company reported total revenues of $3.03 billion and non-GAAP earnings per share of $8.22 for the quarter.
Despite the generally positive results, Regeneron’s stock traded down 3.74% in premarket to $587.99, suggesting investors may have expected stronger performance or are responding to competitive pressures in key markets. The company’s presentation emphasized its science-driven approach and balanced capital allocation strategy, including its newly initiated dividend program.
Quarterly Performance Highlights
Regeneron’s Q1 2025 performance was anchored by continued growth of key products, particularly Dupixent, while facing some headwinds in its ophthalmology franchise.
As shown in the following financial performance summary:
The company highlighted several key pipeline advancements, including regulatory submissions for EYLEA HD in retinal vein occlusion (RVO), Dupixent’s approval for chronic spontaneous urticaria (CSU) in the U.S., and regulatory filings for Libtayo in adjuvant cutaneous squamous cell carcinoma (CSCC). Additionally, Regeneron noted the FDA’s acceptance of BLA resubmissions for two important oncology therapies: linvoseltamab (PDUFA July 10) and odronextamab (PDUFA July 30).
Dupixent’s Growth Story
Dupixent continues to be Regeneron’s primary growth driver, with global net sales reaching $3.7 billion in Q1 2025, representing 20% year-over-year growth. The therapy now serves approximately 1.2 million patients globally across seven approved indications.
The following chart illustrates Dupixent’s consistent growth trajectory:
A significant development for Dupixent is its expansion into chronic obstructive pulmonary disease (COPD), with the U.S. launch underway following FDA approval in September 2024. The therapy has the potential to address approximately 300,000 COPD patients in the U.S. with an eosinophilic phenotype. Notably, Regeneron reported that top commercial and Medicare payers authorized Dupixent coverage "to label" within the first 90 days of approval.
Regeneron is also advancing its "pipeline in a product" strategy for Dupixent, as illustrated in this comprehensive indication map:
The company continues to expand Dupixent’s indications, with recent approvals in chronic spontaneous urticaria (CSU) in the U.S. and COPD in Japan. An sBLA for bullous pemphigoid has been accepted with a PDUFA date of June 20, 2025.
EYLEA Franchise Performance
Regeneron’s ophthalmology franchise, consisting of EYLEA and EYLEA HD, maintained its position as the U.S. anti-VEGF category leader with approximately 41% market share. However, the franchise faces multiple challenges, as shown in the following sales data:
Q1 2025 U.S. net product sales for the combined EYLEA franchise reached $736 million, with EYLEA HD contributing $307 million (29% of total). The presentation noted that quarterly results were impacted by lower inventory, increased competition, category shift to off-label use of compounded Avastin, and patient affordability constraints.
Despite these challenges, Regeneron stated its goal to establish EYLEA HD as the new standard of care for retinal diseases, with a regulatory submission for RVO and every four-week dosing currently under review (PDUFA August 19).
Libtayo and Oncology Portfolio
Libtayo has emerged as Regeneron’s latest internally-discovered blockbuster drug, with worldwide net sales of $285 million in Q1 2025, representing 8% year-over-year growth. U.S. sales were particularly strong at $193 million, up 21% year-over-year.
The following chart illustrates Libtayo’s growth trajectory:
Regeneron positioned Libtayo as a foundational element of its oncology portfolio, noting it is one of only two PD-1 antibodies FDA-approved for use in combination with chemotherapy irrespective of histology or PD-L1 expression levels. The company has submitted regulatory filings in both the U.S. and EU for Libtayo in adjuvant CSCC, where it demonstrated statistically significant disease-free survival benefit.
Pipeline and Future Growth Catalysts
Regeneron outlined several key clinical milestones expected in 2025 that could drive long-term shareholder value:
Of particular note is the company’s dual approach to addressing COPD with both Dupixent (for eosinophilic COPD) and itepekimab (for former smokers regardless of eosinophil count). Pivotal Phase 3 data for itepekimab in former smokers with COPD is expected in mid-2025.
The company is also advancing programs in obesity, with proof-of-concept data expected from the Phase 2 COURAGE study evaluating semaglutide in combination with myostatin inhibition for weight loss while preserving muscle mass.
Financial Outlook
A significant financial milestone for Regeneron is the projected full repayment of its development balance to Sanofi (NASDAQ:SNY) by 2026. This balance represents development costs funded by Sanofi under the companies’ antibody collaboration for certain antibodies, including Dupixent.
As illustrated in the following chart, the balance has been steadily decreasing:
As of Q1 2025, the remaining balance stood at $1.5 billion, down from $3.2 billion at the end of 2021. Regeneron expects to reimburse approximately $800 million per year in 2025 and 2026, with full repayment anticipated by the end of 2026. The elimination of this obligation will free up significant capital that could be deployed toward internal R&D, business development, or returned to shareholders.
Regeneron’s presentation emphasized its balanced approach to capital allocation, prioritizing internal R&D while also returning capital to shareholders through its newly initiated dividend program. The company’s strong pipeline of approximately 45 product candidates addresses therapeutic categories expected to exceed an aggregate of $220 billion by 2030, positioning Regeneron for potential long-term growth despite near-term competitive challenges.
Full presentation:
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.