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Regeneron Stock Plunges 22.6% YTD: Should You Buy, Sell or Hold?
Read MoreHide Full Article
Key Takeaways
REGN shares are down 22.8% YTD due to weak Eylea sales and pipeline disappointments.
Eylea faces intense competition from Vabysmo and biosimilars, with HD version uptake still ramping up.
Dupixent and new oncology approvals offer some support, but setbacks in COPD and lymphoma drugs persist.
Shares of Regeneron Pharmaceuticals, Inc. (REGN - Free Report) have lost 22.6% year to date against the industry’s growth of 0.6%. The stock has underperformed the medical sector and S&P 500 Index in this timeframe.
A decline in lead drug Eylea sales has adversely impacted top-line growth.
Regeneron Underperforms Industry, Sector and S&P 500
Image Source: Zacks Investment Research
While the company is making efforts to diversify its revenue base and develop its oncology franchise, Eylea’s dismal performance in an increasingly competitive environment has dampened investors’ sentiment.
Pipeline setbacks have also hurt the share price of late.
Eylea’s Sales Decline Hampers REGN Ophthalmology Unit
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 in 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. While the initial uptake of Eylea HD was encouraging as Eylea patients transitioned to the higher dose, it will take Eylea HD quite some time to offset the rapid erosion in Eylea sales.
In April 2025, the FDA accepted for priority review a supplemental biologics license application (sBLA) seeking approval of Eylea HD for both the treatment of macular edema following retinal vein occlusion (RVO) and broadening the dosing schedule to include every 4-week (monthly) dosing across approved indications. The FDA has set a target action date of Aug. 19, 2025.
However, the regulatory body issued a complete response letter (“CRL”) for the pre-filled syringe of Eylea HD. Per the company, the key outstanding issue relates to a question posed by the FDA to a third-party component supplier. This component supplier has expeditiously responded to FDA requests for information.
The FDA also issued a CRL regarding the sBLA for the addition of extended dosing intervals. The FDA indicated that the submitted data did not support extended dosing intervals greater than every 16 weeks.
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 Boosts 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.
Strong demand trends and consistent label expansion should fuel Dupixent sales.
REGN’s Focus on Oncology
The company also has other arrows in its quiver. It is looking to strengthen 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.
REGN’s oncology franchise received a boost with the EC’s approval of odronextamab for treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The drug has been approved under the brand name Ordspono.
However, the company’s efforts to get odronextamab approved in the United States suffered a setback. The regulatory body issued CRLs for its biologics license application (BLA) for odronextamab in March 2024.
The FDA accepted for review the resubmission of the BLA for odronextamab with a target action date of July 30, 2025.
Regeneron recently obtained FDA approval of linvoseltamab-gcpt for the treatment of R/R multiple myeloma (MM). The regulatory body granted accelerated approval to linvoseltamab under the brand name Lynozyfic.
Lynozyfic is also approved in the European Union 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 successful development of these oncology drugs should be a great boost for REGN.
REGN Looking to Build an Obesity Franchise
Regeneron is looking to make inroads in the lucrative obesity market.
The company recently 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.
Regeneron will acquire exclusive clinical development and commercial rights for HS-20094, a dual GLP-1/GIP receptor agonist, outside the Chinese Mainland, Hong Kong and Macau.
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.
REGN: Valuation & Estimates
Going by the price/earnings ratio, REGN is expensive at this moment. Shares currently trade at 18.27X forward earnings, slightly lower than its mean of 18.85X but higher than the large-cap pharma industry’s value of 15.04X.
Image Source: Zacks Investment Research
The bottom-line estimate for 2025 has dropped 57 cents to $36.15 over the past 60 days and the same for 2026 has decreased $1.49.
Image Source: Zacks Investment Research
Final Thoughts on Regeneron
Large biotech companies are considered safe havens for investors interested in this sector.
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.
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 did not meet the same.
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, selling it at current levels would be prudent.
Image: Bigstock
Regeneron Stock Plunges 22.6% YTD: Should You Buy, Sell or Hold?
Key Takeaways
Shares of Regeneron Pharmaceuticals, Inc. (REGN - Free Report) have lost 22.6% year to date against the industry’s growth of 0.6%. The stock has underperformed the medical sector and S&P 500 Index in this timeframe.
A decline in lead drug Eylea sales has adversely impacted top-line growth.
Regeneron Underperforms Industry, Sector and S&P 500
Image Source: Zacks Investment Research
While the company is making efforts to diversify its revenue base and develop its oncology franchise, Eylea’s dismal performance in an increasingly competitive environment has dampened investors’ sentiment.
Pipeline setbacks have also hurt the share price of late.
Eylea’s Sales Decline Hampers REGN Ophthalmology Unit
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 in 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. While the initial uptake of Eylea HD was encouraging as Eylea patients transitioned to the higher dose, it will take Eylea HD quite some time to offset the rapid erosion in Eylea sales.
In April 2025, the FDA accepted for priority review a supplemental biologics license application (sBLA) seeking approval of Eylea HD for both the treatment of macular edema following retinal vein occlusion (RVO) and broadening the dosing schedule to include every 4-week (monthly) dosing across approved indications. The FDA has set a target action date of Aug. 19, 2025.
However, the regulatory body issued a complete response letter (“CRL”) for the pre-filled syringe of Eylea HD. Per the company, the key outstanding issue relates to a question posed by the FDA to a third-party component supplier. This component supplier has expeditiously responded to FDA requests for information.
The FDA also issued a CRL regarding the sBLA for the addition of extended dosing intervals. The FDA indicated that the submitted data did not support extended dosing intervals greater than every 16 weeks.
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 Boosts 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.
Strong demand trends and consistent label expansion should fuel Dupixent sales.
REGN’s Focus on Oncology
The company also has other arrows in its quiver. It is looking to strengthen 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.
REGN’s oncology franchise received a boost with the EC’s approval of odronextamab for treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The drug has been approved under the brand name Ordspono.
However, the company’s efforts to get odronextamab approved in the United States suffered a setback. The regulatory body issued CRLs for its biologics license application (BLA) for odronextamab in March 2024.
The FDA accepted for review the resubmission of the BLA for odronextamab with a target action date of July 30, 2025.
Regeneron recently obtained FDA approval of linvoseltamab-gcpt for the treatment of R/R multiple myeloma (MM). The regulatory body granted accelerated approval to linvoseltamab under the brand name Lynozyfic.
Lynozyfic is also approved in the European Union 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 successful development of these oncology drugs should be a great boost for REGN.
REGN Looking to Build an Obesity Franchise
Regeneron is looking to make inroads in the lucrative obesity market.
The company recently 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.
Regeneron will acquire exclusive clinical development and commercial rights for HS-20094, a dual GLP-1/GIP receptor agonist, outside the Chinese Mainland, Hong Kong and Macau.
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.
REGN: Valuation & Estimates
Going by the price/earnings ratio, REGN is expensive at this moment. Shares currently trade at 18.27X forward earnings, slightly lower than its mean of 18.85X but higher than the large-cap pharma industry’s value of 15.04X.
Image Source: Zacks Investment Research
The bottom-line estimate for 2025 has dropped 57 cents to $36.15 over the past 60 days and the same for 2026 has decreased $1.49.
Image Source: Zacks Investment Research
Final Thoughts on Regeneron
Large biotech companies are considered safe havens for investors interested in this sector.
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.
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 did not meet the same.
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, selling it at current levels would be prudent.
REGN currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.