Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) released its financial results for the fourth quarter, highlighting both growth areas and considerable challenges. Adjusted earnings per share for the quarter came in at $11.44, representing a 5% reduction compared to the prior year but surpassing analyst expectations of $10.71. Revenues rose 3% year over year to $3.88 billion, also slightly exceeding consensus forecasts set at $3.79 billion.
Despite the overall revenue growth, the company’s leading eye care treatment, Eylea—including its high-dose formulation Eylea HD—experienced a substantial downturn. U.S. net sales for these products combined declined by 28% compared to the previous year's fourth quarter, totaling $1.08 billion. Specifically, Eylea HD accounted for $506 million with the standard Eylea contributing $577 million.
This significant drop in Eylea sales has been attributed to multiple factors within the competitive ophthalmic market landscape. Key challenges include ongoing competitive pressures that have affected sales volume and market share. Notably, Regeneron’s market presence has been impacted by the increasing use of compounded bevacizumab, which patients may favor due to affordability concerns. Additionally, there is a transition trend among patients shifting from the traditional Eylea formulation to Eylea HD. Lower net selling prices have also contributed to diminished revenue figures.
The regulatory environment has seen recent developments supporting the Eylea HD portfolio. In November 2025, the U.S. Food and Drug Administration (FDA) approved Eylea HD 8 mg injection for treating macular edema following retinal vein occlusion. This indication allows for dosing every eight weeks after an initial monthly loading phase, potentially offering patients a more convenient treatment regimen. The FDA also sanctioned a monthly dosing option that may benefit certain patients requiring a return to more frequent administration across approved indications.
Further regulatory progress was made in December 2025, when Regeneron submitted an application to the FDA to authorize a new manufacturing partner responsible for filling prefilled syringes of Eylea HD. A decision regarding this application is anticipated during the second quarter of 2026. This move aims to bolster supply chain robustness and manufacturing scalability.
Beyond ophthalmology, Regeneron’s collaboration with Sanofi SA (NASDAQ: SNY) continues to be a significant revenue driver. The partnership yielded collaboration revenues of $1.486 billion during the quarter and $5.242 billion for fiscal 2025. These figures reflect an increased share of profits from antibody commercialization, largely fueled by the growing sales of Dupixent, an immunology product jointly developed by the two companies.
In line with its growth strategy, Regeneron reaffirmed its commitment to substantial domestic investment. While already engaged in ongoing and planned investments exceeding $7 billion, the company recently announced an additional allocation of approximately $2 billion toward constructing a bulk manufacturing facility located in Saratoga Springs, New York. This state-of-the-art site is projected to significantly expand the company's manufacturing capacity and is expected to generate around 1,000 high-wage jobs, underscoring Regeneron's commitment to both innovation and economic development.
Looking ahead to fiscal 2026, Regeneron projects its Generally Accepted Accounting Principles (GAAP) gross margin to fall within the 79% to 80% range, whereas adjusted gross margin estimates stand between 83% and 84%. These margins reflect expected efficiencies across the organization amidst ongoing investment in research, development, and sales efforts.
Regarding expenditure forecasts, the company expects adjusted research and development (R&D) expenses between $5.9 billion and $6.1 billion for 2026, maintaining robust investment in its pipeline. Non-GAAP Selling, General and Administrative (SG&A) expenses are anticipated to range from $2.5 billion to $2.65 billion, indicating continued support for commercialization and operational infrastructure.
At the time of reporting, Regeneron’s stock price was modestly down by 0.32% to $747.05, reflecting market fluctuations amid the company’s earnings announcement.