Regeneron Pharmaceuticals is poised to deliver another earnings surprise when it reports Q4 2025 results in early 2026, with investors watching how its expanding oncology portfolio—particularly its cd38 inhibitor Lynozyfic—combines with blockbuster Dupixent profits to drive performance. The biotech giant faces expectations of $3.82 billion in revenues and $10.56 per share in earnings, setting the stage for potential outperformance driven by multiple growth engines.
Strong Earnings Consensus Sets Stage for REGN Potential Upside
Regeneron has established a strong track record of beating Wall Street expectations, surpassing earnings estimates in three of the past four quarters with an average surprise of 21.81%. The company’s most recent performance was particularly impressive, delivering a 25.32% earnings beat in the last reported quarter. This consistent outperformance suggests investor confidence in management’s ability to deliver.
Zacks’ predictive model indicates another earnings beat is in the cards. The combination of a positive Earnings ESP of +0.82% (with the Most Accurate Estimate at $10.65 per share versus the Consensus at $10.56) and a Zacks Rank #1 Strong Buy rating historically increases the probability of beating expectations. This alignment of positive indicators suggests favorable momentum heading into the earnings announcement.
Dupixent Growth and Eylea HD Uptake: The Revenue Pillars
Two pharmaceutical powerhouses are expected to drive Regeneron’s top-line and bottom-line results. Dupixent, developed in collaboration with Sanofi, continues to demonstrate robust market demand across its expanded indications, which now include atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, chronic obstructive pulmonary disease, and bullous pemphigoid. Solid Q4 growth in Dupixent sales should translate into meaningful profit increases for Regeneron, offsetting headwinds in other areas.
On the ophthalmology side, Eylea—the company’s crown jewel developed alongside partner Bayer—has faced competitive pressures from newer alternatives like Vabysmo. To combat this challenge, Regeneron introduced Eylea HD, a higher-potency formulation that has gained rapid traction among patients transitioning from the original dose. Preliminary data shows Q4 U.S. Eylea sales of $577 million, while the new Eylea HD generated $506 million in the same period, demonstrating that the upgraded product is successfully capturing market share and compensating for underlying demand pressures.
The FDA’s November 2025 approval of Eylea HD for macular edema following retinal vein occlusion, with flexible dosing options (up to every eight weeks), further validates the product’s potential to sustain Regeneron’s ophthalmology franchise going forward.
Oncology Expansion with cd38 Inhibitor Lynozyfic Adds New Growth Driver
Beyond traditional revenue sources, Regeneron’s oncology strategy is gaining momentum with several significant approvals. The cd38 inhibitor Lynozyfic (linvoseltamab-gcpt), approved by both the FDA and European Union for treating relapsed or refractory multiple myeloma, represents a critical addition to the company’s cancer-fighting portfolio. This cd38-targeting therapy addresses a substantial unmet need in hematologic malignancies, with accelerated approval status highlighting the drug’s clinical significance.
Alongside Lynozyfic, Libtayo (cemiplimab) continues to expand its market reach, with Q4 revenues projected at $482 million. Recent label expansions in Europe—where the European Commission approved Libtayo as an adjuvant treatment for cutaneous squamous cell carcinoma patients at high recurrence risk following surgery and radiation—broaden its addressable patient population. The FDA granted similar approval, strengthening Libtayo’s competitive positioning.
Ordspono (odronextamab), approved in the European Union for relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma after multiple prior therapies, further diversifies Regeneron’s oncology reach. This multi-pronged cancer strategy reduces dependence on Eylea and creates a more balanced revenue portfolio.
Key Financial Metrics and Share Buyback Program to Watch
Regeneron’s bottom line is expected to benefit from operational efficiencies despite increased R&D spending to advance its pipeline. An important factor supporting earnings per share growth is the company’s aggressive share repurchase program. In February 2025, management authorized an additional $3.0 billion buyback, with $2.156 billion remaining available as of September 2025. Investors should monitor any updates on execution of this repurchase plan, as ongoing share count reduction continues to provide EPS accretion.
Stock Performance Context and Investment Implications
Regeneron shares have appreciated 12.2% over the past year, trailing the broader industry gain of 17.1%, suggesting potential for relative outperformance if the company delivers on Q4 expectations. The combination of Dupixent’s solid performance, Eylea HD’s successful market penetration, and the emerging contribution from Lynozyfic and other oncology assets creates multiple pathways for revenue and earnings growth.
Investors focused on biotech with strong earnings visibility and diversified product portfolios may find Regeneron’s upcoming earnings report particularly relevant to their investment theses, especially as the company’s cd38 inhibitor strategy positions it competitively in the expanding targeted cancer therapy space.
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Can Regeneron's cd38 Inhibitor Lynozyfic and Dupixent Drive Q4 2025 Earnings Beat?
Regeneron Pharmaceuticals is poised to deliver another earnings surprise when it reports Q4 2025 results in early 2026, with investors watching how its expanding oncology portfolio—particularly its cd38 inhibitor Lynozyfic—combines with blockbuster Dupixent profits to drive performance. The biotech giant faces expectations of $3.82 billion in revenues and $10.56 per share in earnings, setting the stage for potential outperformance driven by multiple growth engines.
Strong Earnings Consensus Sets Stage for REGN Potential Upside
Regeneron has established a strong track record of beating Wall Street expectations, surpassing earnings estimates in three of the past four quarters with an average surprise of 21.81%. The company’s most recent performance was particularly impressive, delivering a 25.32% earnings beat in the last reported quarter. This consistent outperformance suggests investor confidence in management’s ability to deliver.
Zacks’ predictive model indicates another earnings beat is in the cards. The combination of a positive Earnings ESP of +0.82% (with the Most Accurate Estimate at $10.65 per share versus the Consensus at $10.56) and a Zacks Rank #1 Strong Buy rating historically increases the probability of beating expectations. This alignment of positive indicators suggests favorable momentum heading into the earnings announcement.
Dupixent Growth and Eylea HD Uptake: The Revenue Pillars
Two pharmaceutical powerhouses are expected to drive Regeneron’s top-line and bottom-line results. Dupixent, developed in collaboration with Sanofi, continues to demonstrate robust market demand across its expanded indications, which now include atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, chronic obstructive pulmonary disease, and bullous pemphigoid. Solid Q4 growth in Dupixent sales should translate into meaningful profit increases for Regeneron, offsetting headwinds in other areas.
On the ophthalmology side, Eylea—the company’s crown jewel developed alongside partner Bayer—has faced competitive pressures from newer alternatives like Vabysmo. To combat this challenge, Regeneron introduced Eylea HD, a higher-potency formulation that has gained rapid traction among patients transitioning from the original dose. Preliminary data shows Q4 U.S. Eylea sales of $577 million, while the new Eylea HD generated $506 million in the same period, demonstrating that the upgraded product is successfully capturing market share and compensating for underlying demand pressures.
The FDA’s November 2025 approval of Eylea HD for macular edema following retinal vein occlusion, with flexible dosing options (up to every eight weeks), further validates the product’s potential to sustain Regeneron’s ophthalmology franchise going forward.
Oncology Expansion with cd38 Inhibitor Lynozyfic Adds New Growth Driver
Beyond traditional revenue sources, Regeneron’s oncology strategy is gaining momentum with several significant approvals. The cd38 inhibitor Lynozyfic (linvoseltamab-gcpt), approved by both the FDA and European Union for treating relapsed or refractory multiple myeloma, represents a critical addition to the company’s cancer-fighting portfolio. This cd38-targeting therapy addresses a substantial unmet need in hematologic malignancies, with accelerated approval status highlighting the drug’s clinical significance.
Alongside Lynozyfic, Libtayo (cemiplimab) continues to expand its market reach, with Q4 revenues projected at $482 million. Recent label expansions in Europe—where the European Commission approved Libtayo as an adjuvant treatment for cutaneous squamous cell carcinoma patients at high recurrence risk following surgery and radiation—broaden its addressable patient population. The FDA granted similar approval, strengthening Libtayo’s competitive positioning.
Ordspono (odronextamab), approved in the European Union for relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma after multiple prior therapies, further diversifies Regeneron’s oncology reach. This multi-pronged cancer strategy reduces dependence on Eylea and creates a more balanced revenue portfolio.
Key Financial Metrics and Share Buyback Program to Watch
Regeneron’s bottom line is expected to benefit from operational efficiencies despite increased R&D spending to advance its pipeline. An important factor supporting earnings per share growth is the company’s aggressive share repurchase program. In February 2025, management authorized an additional $3.0 billion buyback, with $2.156 billion remaining available as of September 2025. Investors should monitor any updates on execution of this repurchase plan, as ongoing share count reduction continues to provide EPS accretion.
Stock Performance Context and Investment Implications
Regeneron shares have appreciated 12.2% over the past year, trailing the broader industry gain of 17.1%, suggesting potential for relative outperformance if the company delivers on Q4 expectations. The combination of Dupixent’s solid performance, Eylea HD’s successful market penetration, and the emerging contribution from Lynozyfic and other oncology assets creates multiple pathways for revenue and earnings growth.
Investors focused on biotech with strong earnings visibility and diversified product portfolios may find Regeneron’s upcoming earnings report particularly relevant to their investment theses, especially as the company’s cd38 inhibitor strategy positions it competitively in the expanding targeted cancer therapy space.