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A month has gone by since the last earnings report for Regeneron (REGN). Shares have added about 20.2% in that time frame, outperforming the S&P 500.
But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is Regeneron due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the latest earnings report in order to get a better handle on the important catalysts.
REGN’s Q3 Earnings Beat, Eylea HD Sales Increase
Regeneron reported third-quarter 2025 adjusted earnings per share (EPS) of $11.83, which comfortably beat the Zacks Consensus Estimate of $9.44. However, the bottom line was down 5% from $12.46 recorded in the year-ago quarter, primarily due to higher expenses.
Total revenues grew 1% year over year to $3.7 billion due to higher sales of Eylea HD and increased Dupixent profits. Revenues also beat the Zacks Consensus Estimate of $3.6 billion.
Eylea HD, Dupiexent Power REGN’s Q3 Results
Lead drug, Eylea, is approved for various ophthalmology indications (neovascular age-related macular degeneration, diabetic macular edema and macular edema, among others).
Eylea’s sales in the United States plunged 41% year over year to $681 million, primarily due to increased competition from other drugs like Roche’s Vabysmo, loss in market share to compounded bevacizumab due to patient affordability constraints and transition of patients to higher doses of the drug (Eylea HD).
Nonetheless, Eylea sales in the United States fell short of the Zacks Consensus Estimate of $686 million.
Please note that Regeneron co-developed Eylea with the HealthCare unit of Bayer AG. Regeneron records net product sales of Eylea and Eylea HD in the United States and Bayer does the same outside the country. The company records its share of profits in connection with Eylea and Eylea HD sales outside the United States within collaboration revenues.
In August 2023, the FDA approved Eylea HD (higher dose of Eylea) for the treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy.
Eylea HD generated revenues of $431 million in the United States, up 10% year over year, due to higher sales volumes driven by increased demand. Eylea HD sales beat the Zacks Consensus Estimate of $414 million.
Total revenues include collaboration revenues of $2 billion from Sanofi and Bayer. The figure increased 18.6% from that recorded in the year-ago quarter. Total collaboration revenues beat the Zacks Consensus Estimate of $1.8 billion.
Sanofi’s collaboration revenues increased 28% to $1.6 billion, driven by profits associated with higher Dupixent sales. The figure beat the Zacks Consensus Estimate of $1.5 billion. We note that Sanofi records global net product sales of Dupixent and Kevzara, while Regeneron records its share of profits/losses in connection with the global sales of both drugs within collaboration revenues.
Dupixent’s sales increased 27% year over year to $4.86 billion.
Bayer’s collaboration revenues totaled $345 million, down 12% year over year.
Regeneron records net product sales of Praluent in the United States and Sanofi does the same outside the country. SNY pays REGN a royalty on such sales. Regeneron records global net product sales of Libtayo and pays Sanofi a royalty on such sales.
Total Libtayo sales were $365.2 million, up 27% year over year. The figure, however, missed the Zacks Consensus Estimate of $370 million.
Praluent’s net sales in the United States were $67.7 million. Kevzara recorded global sales of $154 million, up 28% from the year-ago quarter’s level.
Gross margin on net product sales decreased to 86% from 89% due to ongoing investments to support the manufacturing operations.
Adjusted R&D expenses increased 18% year over year to $1.3 billion due to the advancement of the company's pipeline. Adjusted SG&A expenses decreased 12% to $541 million.
In February 2025, the board of directors authorized a new share repurchase program to repurchase up to an additional $3.0 billion of the common stock. During the second quarter of 2025, REGN repurchased shares for $663 million.
As of June 30, 2025, approximately $2.156 billion remained available for share repurchases.
Key Pipeline and Regulatory Updates
The European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Dupixent in the European Union (EU) for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older who remain symptomatic despite antihistamine treatment.
A decision from the European Commission is expected in the coming months.
The FDA issued a complete response letter (CRL) for the pre-filled syringe supplemental biologics license application (sBLA) seeking approval of Eylea HD. The sole approvability issue cited in the CRL relates to unresolved inspection findings at Catalent.
Regeneron is planning to submit an application to include a new pre-filled syringe manufacturing filler in the Eylea HD BLA by January 2026.
The FDA recently approved the label expansion of PD-1 inhibitor Libtayo as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (“CSCC”) at high risk of recurrence after surgery and radiation.
The EMA's CHMP also adopted a positive opinion on Libtayo for the adjuvant treatment of CSCC.
Regeneron also announced that the primary and key secondary endpoints were met in a phase III study of cemdisiran (siRNA therapy), as both a monotherapy and in combination with pozelimab (C5 antibody), in adults with generalized myasthenia gravis. A regulatory submission for cemdisiran monotherapy is planned for the first quarter of 2026 in the United States pending discussions with the FDA.
Since the earnings release, investors have witnessed a upward trend in estimates review.
The consensus estimate has shifted 12.49% due to these changes.
At this time, Regeneron has a subpar Growth Score of D, however its Momentum Score is doing a bit better with a C. Charting a somewhat similar path, the stock was allocated a grade of B on the value side, putting it in the second quintile for this investment strategy.
Overall, the stock has an aggregate VGM Score of C. If you aren't focused on one strategy, this score is the one you should be interested in.
Estimates have been broadly trending upward for the stock, and the magnitude of these revisions looks promising. Interestingly, Regeneron has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.
Regeneron is part of the Zacks Medical - Biomedical and Genetics industry. Over the past month, Viking Therapeutics, Inc. (VKTX), a stock from the same industry, has gained 3%. The company reported its results for the quarter ended September 2025 more than a month ago.
Viking Therapeutics reported revenues of $0 million in the last reported quarter, representing a year-over-year change of 0%. EPS of -$0.81 for the same period compares with -$0.22 a year ago.
Viking Therapeutics is expected to post a loss of $0.88 per share for the current quarter, representing a year-over-year change of -175%. Over the last 30 days, the Zacks Consensus Estimate remained unchanged.
Viking Therapeutics has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of F.
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This article originally published on Zacks Investment Research (zacks.com).
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