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REGN Loses 21.1% Year to Date: Buy, Sell or Hold the Sock?
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Key Takeaways
Regeneron stock has dropped 21.1% YTD, underperforming the industry, sector, and S&P 500.
Eylea sales face pressure from Roche's Vabysmo, while Eylea HD posts U.S. growth.
Dupixent and new oncology approvals like Lynozyfic and Ordspono support Regeneron's outlook.
Shares of Regeneron Pharmaceuticals ((REGN - Free Report) ) have lost 21.1% year to date against the industry’s growth of 5.2%. The stock has also underperformed the sector and the S&P 500 Index during this time frame.
While the stock has recovered some lost ground after having touched a 52-week low of $476.49 on June 5, the year-to-date returns remain in the red.
Lead drug Eylea’s dismal performance has dampened investor sentiment. Pipeline setbacks have also hurt the share price. Nonetheless, the progress with the oncology portfolio is encouraging.
REGN Underperforms Industry, Sector and S&P 500 Index
Image Source: Zacks Investment Research
Let us analyze the company’s strengths and weaknesses in such a scenario to make a prudent investment choice:
REGN’s Eylea HD Sales Gain as Eylea Declines
Eylea, an anti-vascular endothelial growth factor inhibitor (VEGF), is approved for various ophthalmology indications. The drug is the biggest revenue contributor to the top line.
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.
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, the FDA recently extended the target action dates for two regulatory submissions for Eylea HD Injection 8 mg to the fourth quarter of 2025.
The submission includes a Chemistry, Manufacturing and Controls Prior-Approval Supplement for the Eylea HD prefilled syringe and a supplemental biologics license application seeking approval for both the treatment of macular edema following retinal vein occlusion and the broadening of the dosing schedule to include every four-week (monthly) dosing across approved indications.
The FDA extended the review periods after determining that the information submitted following a recent inspection of a third-party manufacturer constituted a major amendment to each application. The delay resulted from observations during an FDA general site inspection of Catalent Indiana LLC (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.
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’s oncology franchise 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 (NSCLC).
Libtayo’s performance has been good so far, as sales totaled $661.6 million 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 drug was granted accelerated approval by the FDA 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 also 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.
REGN Looking to Build an Obesity Franchise
Regeneron is looking to make inroads in the lucrative obesity market. The company had earlier entered into an in-licensing agreement for an obesity drug with Hansoh Pharmaceuticals Group Company Limited, in a bid to expand its clinical-stage obesity portfolio.
The licensing agreement with Hansoh Pharma provides Regeneron with HS-20094, a GLP-1/GIP receptor agonist. The in-licensing agreement for an obesity candidate will expand REGN’s obesity pipeline, which includes trevogrumab.
The successful development of any obesity treatment will be a great boost for the company.
The company also announced results evaluating its first-in-class investigational allergen-blocking antibodies in allergen-challenge phase III studies in adults with moderate-to-severe cat or birch allergies. Both trials met their respective primary and key secondary endpoints.
REGN: Valuation & Estimates
Going by the price/earnings ratio, REGN is expensive at this moment. Shares currently trade at 17.87X forward earnings, lower than its mean of 18.71X but higher than the large-cap pharma industry’s value of 14.79X.
Image Source: Zacks Investment Research
The bottom-line estimate for 2025 has moved up $2.22 to $38.71 over the past 60 days and the same for 2026 has increased 63 cents.
Image Source: Zacks Investment Research
Final Thoughts on Regeneron
REGN is one of the largest biotechs in the biotech sector that are considered safe havens for investors interested in this sector. REGN’s progress with the oncology portfolio should enable 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 continue to fuel its sales and help REGN earn higher profits.
However, Regeneron is sailing in troubled waters as of now and has a tough road ahead, as it will take a long time for Eylea HD to replace Eylea sales.
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.
We believe that the near-term pipeline setbacks and challenges with Eylea weigh on the stock for now. We would advise prospective investors to be on the sidelines for the time being. For investors already owning the stock, staying invested at current levels would be prudent.
Image: Bigstock
REGN Loses 21.1% Year to Date: Buy, Sell or Hold the Sock?
Key Takeaways
Shares of Regeneron Pharmaceuticals ((REGN - Free Report) ) have lost 21.1% year to date against the industry’s growth of 5.2%. The stock has also underperformed the sector and the S&P 500 Index during this time frame.
While the stock has recovered some lost ground after having touched a 52-week low of $476.49 on June 5, the year-to-date returns remain in the red.
Lead drug Eylea’s dismal performance has dampened investor sentiment. Pipeline setbacks have also hurt the share price. Nonetheless, the progress with the oncology portfolio is encouraging.
REGN Underperforms Industry, Sector and S&P 500 Index
Image Source: Zacks Investment Research
Let us analyze the company’s strengths and weaknesses in such a scenario to make a prudent investment choice:
REGN’s Eylea HD Sales Gain as Eylea Declines
Eylea, an anti-vascular endothelial growth factor inhibitor (VEGF), is approved for various ophthalmology indications. The drug is the biggest revenue contributor to the top line.
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.
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, the FDA recently extended the target action dates for two regulatory submissions for Eylea HD Injection 8 mg to the fourth quarter of 2025.
The submission includes a Chemistry, Manufacturing and Controls Prior-Approval Supplement for the Eylea HD prefilled syringe and a supplemental biologics license application seeking approval for both the treatment of macular edema following retinal vein occlusion and the broadening of the dosing schedule to include every four-week (monthly) dosing across approved indications.
The FDA extended the review periods after determining that the information submitted following a recent inspection of a third-party manufacturer constituted a major amendment to each application. The delay resulted from observations during an FDA general site inspection of Catalent Indiana LLC (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.
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’s oncology franchise 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 (NSCLC).
Libtayo’s performance has been good so far, as sales totaled $661.6 million 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 drug was granted accelerated approval by the FDA 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 also 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.
REGN Looking to Build an Obesity Franchise
Regeneron is looking to make inroads in the lucrative obesity market. The company had earlier entered into an in-licensing agreement for an obesity drug with Hansoh Pharmaceuticals Group Company Limited, in a bid to expand its clinical-stage obesity portfolio.
The licensing agreement with Hansoh Pharma provides Regeneron with HS-20094, a GLP-1/GIP receptor agonist. The in-licensing agreement for an obesity candidate will expand REGN’s obesity pipeline, which includes trevogrumab.
The successful development of any obesity treatment will be a great boost for the company.
The company also announced results evaluating its first-in-class investigational allergen-blocking antibodies in allergen-challenge phase III studies in adults with moderate-to-severe cat or birch allergies. Both trials met their respective primary and key secondary endpoints.
REGN: Valuation & Estimates
Going by the price/earnings ratio, REGN is expensive at this moment. Shares currently trade at 17.87X forward earnings, lower than its mean of 18.71X but higher than the large-cap pharma industry’s value of 14.79X.
Image Source: Zacks Investment Research
The bottom-line estimate for 2025 has moved up $2.22 to $38.71 over the past 60 days and the same for 2026 has increased 63 cents.
Image Source: Zacks Investment Research
Final Thoughts on Regeneron
REGN is one of the largest biotechs in the biotech sector that are considered safe havens for investors interested in this sector. REGN’s progress with the oncology portfolio should enable 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 continue to fuel its sales and help REGN earn higher profits.
However, Regeneron is sailing in troubled waters as of now and has a tough road ahead, as it will take a long time for Eylea HD to replace Eylea sales.
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.
We believe that the near-term pipeline setbacks and challenges with Eylea weigh on the stock for now. We would advise prospective investors to be on the sidelines for the time being. For investors already owning the stock, staying invested at current levels would be prudent.
REGN currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.