Regeneron (REGN) Down as Q4 Eylea Preliminary Sales Disappoint
Shares of Regeneron Pharmaceuticals, Inc. REGN declined 1.13% after the company reported disappointing fourth-quarter preliminary sales for lead drug, Eylea.
Sales of Eylea (aflibercept) and Eylea HD (higher dose of Eylea) came in at $1.46 billion in the United States. The Zacks Consensus Estimate for the same was $1.45 billion.
Eylea sales came in at $1.34 billion in the United States and Eylea HD sales came in at $123 million in the fourth quarter of 2023. This was the first full quarter for Eylea HD following its launch.
In August 2023, the FDA approved aflibercept 8 mg for the treatment of patients with wet age-related macular degeneration (“wAMD”), diabetic macular edema (“DME”) and diabetic retinopathy under the brand name Eylea HD.
Sales of Eylea disappointed investors and the stock was down on the same.
Shares of Regeneron have gained 28.4% in the past six months compared with the industry’s growth of 2.4%.
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Eylea sales have been under pressure in 2023 due to competition from Roche’s RHHBY Vabysmo.
The uptake of Vabysmo has been outstanding. RHHBY designed Vabysmo to block pathways involving Ang-2 and VEGF-A. The European Commission also approved Vabysmo for these indications.
Competition has impacted sales in the fourth quarter as well.
Please note that Regeneron co-developed Eylea with Bayer BAYRY. Regeneron records the net product sales of Eylea in the United States and Bayer records its net product sales outside the country. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States.
Bayer recently obtained approval of aflibercept 8 mg for the indications of wAMD and DME in the European Union.
Sales of Eylea HD are expected to pick up further and offset the decline in Eylea sales.
Meanwhile, Regeneron’s top line also comprises profits from Dupixent.
The drug maintains its stellar performance, driven by continued strong demand in the approved indications, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis.
Regeneron has a collaboration agreement with Sanofi SNY for Dupixent. We note that Sanofi records global net product sales of Dupixent and Kevzara, while Regeneron records its share of profits/losses in connection with global sales of both drugs.
Regeneron is looking to solidify its presence in the lucrative oncology space. Its portfolio already includes an approved PD-1 inhibitor, Libtayo, which is approved to treat people with a type of skin cancer called cutaneous squamous cell carcinoma that has spread or cannot be cured by surgery or radiation. Libtayo sales have been strong in 2023 and the drug is poised to rake in sales in excess of $1 billion in 2024.
Other promising oncology candidates are odronextamab, linvoseltamab, ubamatamab fianlimab, REGN5837 and REGN4336.
In September 2023, the FDA accepted for priority review the biologics license application for odronextamab to treat adult patients with relapsed/refractory follicular lymphoma and relapsed/refractory diffuse large B cell lymphoma who have progressed after at least two prior systemic therapies. The regulatory body has set a target action date of Mar 31, 2024. A regulatory application for odronextamab has also been submitted to the European Union.
The FDA granted Fast Track designation to fianlimab, an antibody to LAG-3, in combination with Libtayo (cemiplimab) for the first-line treatment of patients with metastatic melanoma. A phase III study is ongoing.
Regeneron also has promising candidates in its pipeline in the lucrative space of obesity.
The company currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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