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Can Eylea HD and Dupixent Profits Revive Regeneron Stock?
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Key Takeaways
Dupixent sales and Eylea HD growth help counter Eyleas ongoing sales decline.
Oncology portfolio grows with new FDA approvals for Lynozyfic and Ordspono.
FDA review delays tied to Catalent site issues weigh on Eylea HD and odronextamab.
Biotech giant Regeneron’s ((REGN - Free Report) ) performance has been pretty ho-hum in the year so far. While Eylea sales continue to be under pressure, affecting the top line, the company finally managed to post revenue growth in the second quarter, giving anxious investors some relief.
Eylea’s dismal performance in an increasingly competitive environment has dampened investors’ sentiment of late. Pipeline setbacks have also hurt the share price. Nonetheless, the progress with the oncology portfolio is encouraging.
REGN’s Eylea HD Sales Gain as Eylea Declines
Lead drug Eylea is an anti-vascular endothelial growth factor inhibitor approved for various ophthalmology indications. Eylea sales have boosted the company’s top line for many years. However, Eylea’s sales have been under pressure for the past couple of years due to competition from Roche’s ((RHHBY - Free Report) ) Vabysmo.
The uptake of Roche’s Vabysmo has been phenomenal. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A.
Biosimilar competition for Eylea is also worrisome. Since Eylea accounts for a majority of REGN’s sales, a rapid decline in sales has adversely impacted the company’s top line.
To counter the decline in Eylea sales, Regeneron has developed a higher dose of the drug. Eylea HD sales in the United States surged 29% in the second quarter due to higher sales volumes driven by increased demand.
However, Regeneron expects regulatory approvals to be delayed for its currently pending FDA applications for Eylea HD (pre-filled syringe, every-four-week dosing, and for the treatment of macular edema following retinal vein occlusion), which have target action dates in August 2025. The anticipated delay is related to observations from an FDA general site inspection at the filler for Eylea HD in these regulatory applications, Catalent Indiana LLC (which was recently acquired by Novo Nordisk).
Regeneron has a collaboration agreement with Bayer ((BAYRY - Free Report) ) for Eylea. Regeneron records the net product sales of Eylea and Eylea HD in the United States, and Bayer records its net product sales outside the country. Regeneron records its share of profits in connection with Eylea’s sales outside the United States.
Dupixent Profits Boost REGN’s Top Line
REGN’s top line also comprises its share of profits/losses in connection with the global sales of Dupixent. Partner Sanofi ((SNY - Free Report) ) records global net product sales of Dupixent.
Solid sales of Dupixent (approved for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis) have fueled the top line for Sanofi and Regeneron.
SNY and REGN are working to expand the drug’s label further. The FDA had earlier approved Dupixent for chronic obstructive pulmonary disease (COPD). The approved indication is an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype.
In April 2025, Dupixent’s label was further expanded for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria who remain symptomatic despite antihistamine treatment. The FDA recently approved Dupixent for the treatment of adult patients with bullous pemphigoid. Regulatory applications are under review in the European Union (EU) and Japan.
Strong demand trends and consistent label expansion should fuel Dupixent sales.
REGN Broadens Oncology Portfolio
REGN is looking to expand its oncology franchise, which comprises Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer.
Libtayo sales totaled $561.3 in the first half of 2025, up 18% year over year. Regeneron records global net product sales of Libtayo and pays Sanofi a royalty on such sales.
The FDA accepted for priority review a supplemental biologics license application (sBLA) for Libtayo (cemiplimab) in adjuvant cutaneous squamous cell carcinoma, with a target action date in October 2025.
REGN’s oncology franchise received a boost with the recent FDA approval of linvoseltamab-gcpt for the treatment of relapsed or refractory (R/R) multiple myeloma (MM). The regulatory body granted accelerated approval to linvoseltamab under the brand name Lynozyfic. Lynozyfic is also approved in the 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 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 strengthened its oncology franchise.
However, the company’s efforts to get odronextamab approved in the United States suffered a setback. The FDA recently issued a complete response letter for the BLA for odronextamab. The BLA was impacted by the Catalent Indiana LLC site inspection.
Road Ahead for REGN: Final Thoughts
REGN’s progress with the oncology portfolio should enable the company’s focus on diversification of top-line growth. Libtayo has put up a good show and a potential label expansion in adjuvant CSCC should boost growth.
Consistent label expansions of Dupixent continues to fuel its sales and help REGN earn higher profits.
Eylea HD sales have gained traction, thereby offsetting the impact of decline in Eylea Sales. However, Eylea was the top revenue generator for REGN and a decline in its sales has adversely impacted the momentum.
Pipeline setbacks are worrisome as well. The stock got hammered at the end of May after REGN and partner Sanofi reported mixed results from two late-stage studies, AERIFY-1 and AERIFY-2, on itepekimab for the treatment of chronic obstructive pulmonary disease. While the AERIFY-1 study met the primary endpoint, AERIFY-2 failed to do so.
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Can Eylea HD and Dupixent Profits Revive Regeneron Stock?
Key Takeaways
Biotech giant Regeneron’s ((REGN - Free Report) ) performance has been pretty ho-hum in the year so far. While Eylea sales continue to be under pressure, affecting the top line, the company finally managed to post revenue growth in the second quarter, giving anxious investors some relief.
Eylea’s dismal performance in an increasingly competitive environment has dampened investors’ sentiment of late. Pipeline setbacks have also hurt the share price. Nonetheless, the progress with the oncology portfolio is encouraging.
REGN’s Eylea HD Sales Gain as Eylea Declines
Lead drug Eylea is an anti-vascular endothelial growth factor inhibitor approved for various ophthalmology indications. Eylea sales have boosted the company’s top line for many years. However, Eylea’s sales have been under pressure for the past couple of years due to competition from Roche’s ((RHHBY - Free Report) ) Vabysmo.
The uptake of Roche’s Vabysmo has been phenomenal. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A.
Biosimilar competition for Eylea is also worrisome. Since Eylea accounts for a majority of REGN’s sales, a rapid decline in sales has adversely impacted the company’s top line.
To counter the decline in Eylea sales, Regeneron has developed a higher dose of the drug. Eylea HD sales in the United States surged 29% in the second quarter due to higher sales volumes driven by increased demand.
However, Regeneron expects regulatory approvals to be delayed for its currently pending FDA applications for Eylea HD (pre-filled syringe, every-four-week dosing, and for the treatment of macular edema following retinal vein occlusion), which have target action dates in August 2025. The anticipated delay is related to observations from an FDA general site inspection at the filler for Eylea HD in these regulatory applications, Catalent Indiana LLC (which was recently acquired by Novo Nordisk).
Regeneron has a collaboration agreement with Bayer ((BAYRY - Free Report) ) for Eylea. Regeneron records the net product sales of Eylea and Eylea HD in the United States, and Bayer records its net product sales outside the country. Regeneron records its share of profits in connection with Eylea’s sales outside the United States.
Dupixent Profits Boost REGN’s Top Line
REGN’s top line also comprises its share of profits/losses in connection with the global sales of Dupixent. Partner Sanofi ((SNY - Free Report) ) records global net product sales of Dupixent.
Solid sales of Dupixent (approved for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis) have fueled the top line for Sanofi and Regeneron.
SNY and REGN are working to expand the drug’s label further. The FDA had earlier approved Dupixent for chronic obstructive pulmonary disease (COPD). The approved indication is an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype.
In April 2025, Dupixent’s label was further expanded for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria who remain symptomatic despite antihistamine treatment. The FDA recently approved Dupixent for the treatment of adult patients with bullous pemphigoid. Regulatory applications are under review in the European Union (EU) and Japan.
Strong demand trends and consistent label expansion should fuel Dupixent sales.
REGN Broadens Oncology Portfolio
REGN is looking to expand its oncology franchise, which comprises Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer.
Libtayo sales totaled $561.3 in the first half of 2025, up 18% year over year. Regeneron records global net product sales of Libtayo and pays Sanofi a royalty on such sales.
The FDA accepted for priority review a supplemental biologics license application (sBLA) for Libtayo (cemiplimab) in adjuvant cutaneous squamous cell carcinoma, with a target action date in October 2025.
REGN’s oncology franchise received a boost with the recent FDA approval of linvoseltamab-gcpt for the treatment of relapsed or refractory (R/R) multiple myeloma (MM). The regulatory body granted accelerated approval to linvoseltamab under the brand name Lynozyfic. Lynozyfic is also approved in the 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 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 strengthened its oncology franchise.
However, the company’s efforts to get odronextamab approved in the United States suffered a setback. The FDA recently issued a complete response letter for the BLA for odronextamab. The BLA was impacted by the Catalent Indiana LLC site inspection.
Road Ahead for REGN: Final Thoughts
REGN’s progress with the oncology portfolio should enable the company’s focus on diversification of top-line growth. Libtayo has put up a good show and a potential label expansion in adjuvant CSCC should boost growth.
Consistent label expansions of Dupixent continues to fuel its sales and help REGN earn higher profits.
Eylea HD sales have gained traction, thereby offsetting the impact of decline in Eylea Sales. However, Eylea was the top revenue generator for REGN and a decline in its sales has adversely impacted the momentum.
Pipeline setbacks are worrisome as well. The stock got hammered at the end of May after REGN and partner Sanofi reported mixed results from two late-stage studies, AERIFY-1 and AERIFY-2, on itepekimab for the treatment of chronic obstructive pulmonary disease. While the AERIFY-1 study met the primary endpoint, AERIFY-2 failed to do so.