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REGN Stock Up on Q3 Earnings Beat, Eylea HD Sales Increase
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Key Takeaways
Regeneron posted Q3 EPS of $11.83, topping estimates but down 5% from last year on higher costs.
Revenues rose 1% to $3.7B, driven by Dupixent's 27% surge and Eylea HD's growing demand.
Libtayo sales climbed 27%, while new oncology approvals strengthen Regeneron's therapeutic portfolio.
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) 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.
Shares are trading up in response to the better-than-expected quarterly results.
Regeneron’s shares have lost 17.8% year to date against the industry’s growth of 10.3%.
Image Source: Zacks Investment Research
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 (RHHBY - Free Report) 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 (BAYRY - Free Report) . 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 (SNY - Free Report) 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.
REGN’s 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.
REGN 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.
REGN 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.
Our Take on REGN’s Q3 Performance
Regeneron's performance in the third quarter was encouraging as revenues grew despite declining sales of its lead drug Eylea.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Eylea sales continue to be on the downslide due to competition from Vabysmo. We note that Vabysmo's uptake has been outstanding. Roche designed Vabysmo to block pathways involving Ang-2 and VEGF-A.
Nonetheless, REGN is looking to strengthen its oncology portfolio to diversify its revenue stream.
The company’s oncology franchise received a boost with the recent FDA approval of a label expansion of Libtayo.
The regulatory body had earlier approved linvoseltamab-gcpt for the treatment of relapsed or refractory (R/R) multiple myeloma (MM). The drug was granted accelerated approval by the FDA under the brand name Lynozyfic. It is also approved in the European Union (EU) to treat adults with R/R MM after at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
The EU approval of Ordspono (odronextamab) for treating adult patients with R/R follicular lymphoma or R/R diffuse large B-cell lymphoma after two or more lines of systemic therapy has also strengthened its oncology franchise.
Image: Bigstock
REGN Stock Up on Q3 Earnings Beat, Eylea HD Sales Increase
Key Takeaways
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) 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.
Shares are trading up in response to the better-than-expected quarterly results.
Regeneron’s shares have lost 17.8% year to date against the industry’s growth of 10.3%.
Image Source: Zacks Investment Research
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 (RHHBY - Free Report) 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 (BAYRY - Free Report) . 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 (SNY - Free Report) 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.
REGN’s 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.
REGN 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.
REGN 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.
Our Take on REGN’s Q3 Performance
Regeneron's performance in the third quarter was encouraging as revenues grew despite declining sales of its lead drug Eylea.
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Regeneron Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Regeneron Pharmaceuticals, Inc. Quote
Eylea sales continue to be on the downslide due to competition from Vabysmo. We note that Vabysmo's uptake has been outstanding. Roche designed Vabysmo to block pathways involving Ang-2 and VEGF-A.
Nonetheless, REGN is looking to strengthen its oncology portfolio to diversify its revenue stream.
The company’s oncology franchise received a boost with the recent FDA approval of a label expansion of Libtayo.
The regulatory body had earlier approved linvoseltamab-gcpt for the treatment of relapsed or refractory (R/R) multiple myeloma (MM). The drug was granted accelerated approval by the FDA under the brand name Lynozyfic. It is also approved in the European Union (EU) to treat adults with R/R MM after at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
The EU approval of Ordspono (odronextamab) for treating adult patients with R/R follicular lymphoma or R/R diffuse large B-cell lymphoma after two or more lines of systemic therapy has also strengthened its oncology franchise.
Zacks Rank
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.