U.S. net product sales of EYLEA HD surged by 88% to $1,088.1 million for the six months ended June 30, 2025, reflecting successful uptake and patient transition. This strong performance partially mitigated a 29% decline in U.S. EYLEA sales to $1,490.3 million, resulting in a 14% overall decrease for the combined EYLEA franchise in the U.S.

The FDA issued Complete Response Letters (CRLs) for EYLEA HD's extended dosing intervals and pre-filled syringe, as well as for odronextamab's Biologics License Application (BLA). These delays are linked to observations from a general site inspection at a third-party filler, Catalent Indiana LLC, impacting anticipated approval timelines.

In July 2025, Regeneron's license agreement with Hansoh Pharmaceuticals Group Company Limited became effective, involving an $80.0 million up-front payment for HS-20094, a dual GLP-1/GIP receptor agonist in Phase 3 clinical development. This acquisition aims to explore combinations with existing products to address obesity and related comorbidities.

Research and development expenses increased by $300.7 million, or 12.3%, to $2,749.1 million for the six months ended June 30, 2025, compared to the prior year period. This substantial investment reflects ongoing efforts to advance clinical programs and discover new product candidates.

The Company repurchased $2,102.9 million of Common Stock during the six months ended June 30, 2025, with $2.814 billion remaining available under current authorizations as of that date. This active repurchase program signals management's confidence in the company's valuation and future cash flow generation.

Selling, general, and administrative (SG&A) expenses decreased by $180.6 million for the six months ended June 30, 2025, primarily due to lower charitable contributions. However, gross margin on net product sales declined by 400 basis points, partly due to ongoing investments in manufacturing operations and higher inventory write-offs, indicating some operational headwinds.

U.S. net product sales of EYLEA declined by 29% for the six months ended June 30, 2025, primarily due to competitive pressures, including the launch of biosimilar versions of EYLEA in Q4 2024, and patient transition to EYLEA HD. The Company expects continued negative impact from biosimilar competition in the U.S. and internationally.

Regeneron is involved in numerous patent infringement lawsuits and post-grant proceedings related to EYLEA, including against Mylan, Biocon, Samsung Bioepis, and Amgen. While some preliminary injunctions have been affirmed, the outcome of these complex legal battles, which could impact market exclusivity, remains uncertain.

The Company faces ongoing Department of Justice investigations and civil lawsuits related to alleged anti-kickback violations and false claims. A jury recently awarded Regeneron $135.6 million in compensatory and $271.2 million in punitive damages in the Praluent antitrust lawsuit, but other legal matters continue to pose potential financial and reputational risks.

EYLEA HD U.S. net product sales grew 88% year-over-year for the six months ended June 30, 2025, demonstrating strong adoption. However, this growth was insufficient to offset the 29% decline in EYLEA U.S. sales, leading to a 14% overall decrease for the combined EYLEA HD and EYLEA franchise in the U.S. due to biosimilar competition and patient transitions.

Despite a competitive landscape including systemic JAK inhibitors and other antibodies, Dupixent's global net product sales (as recorded by Sanofi) increased by 21% to $8,010.2 million for the six months ended June 30, 2025. This indicates continued market acceptance and differentiation of the product.

The Company notes that patient affordability constraints have led to a loss in market share for EYLEA to compounded bevacizumab. Additionally, the Inflation Reduction Act and other government and payor measures are expected to continue challenging drug pricing, potentially impacting future revenue and market access.

Total research and development expenses rose by $300.7 million, or 12.3%, to $2,749.1 million for the six months ended June 30, 2025, compared to the same period in 2024. This increase is driven by direct R&D expenses and indirect costs, indicating a continued commitment to innovation and clinical development.

The gross margin on net product sales decreased to 82% for the six months ended June 30, 2025, from 86% in the prior year period. This contraction is partly attributed to ongoing investments to support manufacturing operations and higher inventory write-offs and reserves.

Inventories increased to $3,205.6 million as of June 30, 2025, from $3,087.3 million as of December 31, 2024. This rise, coupled with the noted manufacturing investments and write-offs, suggests efforts to manage supply chain performance, potentially in response to expected demand or operational bottlenecks.

Research and development expenses increased by 12.3% to $2,749.1 million for the six months ended June 30, 2025, highlighting significant investment in advancing numerous product candidates across various therapeutic areas. The pipeline includes multiple programs in Phase 2 and Phase 3, leveraging proprietary technologies like VelocImmune and strategic collaborations.

The Company acquired an FDA Rare Pediatric Disease Priority Review Voucher for $155.0 million and entered a license agreement with Hansoh Pharmaceuticals for a dual GLP-1/GIP receptor agonist. Collaborations with Alnylam (RNAi therapeutics) and Intellia (CRISPR/Cas9 gene-editing) further expand Regeneron's technological capabilities and future product opportunities.

The Company is increasingly utilizing AI-based solutions across its operations, which introduces inherent risks. These include potential misuse leading to impermissible data disclosure, reputational harm, and the need to comply with evolving new regulations concerning ethical use, privacy, and security of AI solutions.

Regeneron repurchased $2,102.9 million of Common Stock during the six months ended June 30, 2025, demonstrating a significant commitment to returning capital to shareholders. As of June 30, 2025, $2.814 billion remained available under the existing share repurchase programs.

The Company declared and paid quarterly cash dividends of $0.88 per share on its Common Stock and Class A Stock in both the first and second quarters of 2025, totaling $186.4 million in dividends paid for the six-month period. This consistent dividend policy reflects a stable return to investors.

Capital expenditures for the six months ended June 30, 2025, totaled $448.3 million, primarily for the expansion of research, preclinical manufacturing, and support facilities at the Tarrytown, New York headquarters. The Company expects to incur $880 million to $950 million in capital expenditures for the full year 2025, indicating ongoing investment in infrastructure.

The Company continues to dedicate significant resources to comply with federal and state healthcare laws, including anti-kickback statutes and False Claims Act. While no specific ESG section is provided, adherence to these regulations is crucial for social responsibility and ethical conduct in the pharmaceutical industry.

Multiple shareholder derivative complaints were filed in 2025, alleging breaches of fiduciary duties by board members and executive officers related to alleged misconduct and excessive director compensation. These lawsuits underscore ongoing scrutiny of governance practices and potential areas for improvement.

The Company identifies risks related to collecting, processing, and sharing personal data, subject to evolving privacy laws like GDPR, and the increasing use of AI-based solutions, which introduces new ethical and privacy challenges. Managing these risks is critical for maintaining trust and regulatory compliance.

The Inflation Reduction Act (IRA) and the recently signed 'One Big Beautiful Bill Act' (OBBBA) introduce significant changes to U.S. corporate income tax laws and drug pricing mechanisms, including Medicare price negotiation. Regeneron is evaluating the impact of OBBBA, indicating a dynamic and potentially challenging regulatory environment.

The Company acknowledges risks to its clinical trials in countries like Russia, Ukraine, and Israel due to armed conflicts and related developments. Such instability could lead to delays, disruptions in supply chains, and challenges in accessing data or monitoring sites, potentially impacting development timelines.

The loss of EYLEA market share to compounded bevacizumab due to patient affordability constraints highlights a broader industry trend towards cost-effectiveness. This, coupled with payor restrictions and government initiatives to control drug prices, suggests continued pressure on pricing power and reimbursement models.