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Regeneron (REGN) Stock Rallies 10% YTD: What Lies Ahead?

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Shares of Regeneron (REGN - Free Report) have gained 10.3% year to date against the industry’s decline of 14.8%.

Regeneron managed to reverse its decline trajectory with the recent FDA approval of a higher dose of its lead drug, Eylea (aflibercept).

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In August, the FDA finally approved aflibercept 8 mg for the treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy under the brand name Eylea HD.

Following its launch in late August, Eylea HD performed well, recording net product sales of $43 million in the final six weeks of the third quarter.

Earlier this month, Regeneron delivered better-than-expected third-quarter 2023 results, even though the sales of lead drug Eylea declined. Profits from Dupixent boosted the top line. Dupixent maintained 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 Pharmaceuticals, Inc. Price, Consensus and EPS Surprise

 

Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise

Regeneron Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Regeneron Pharmaceuticals, Inc. Quote

Regeneron has a collaboration agreement with Sanofi (SNY - Free Report) 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.

Dupixent’s uptake for the eosinophilic esophagitis indication has been strong and its demand is also robust for the prurigo nodularis indication. Additional label expansion of the drug will boost its sales.

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.

The pipeline progress has been encouraging as well. 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.

Eylea sales have been under pressure in the last couple of quarters due to competition from Roche’s (RHHBY - Free Report) Vabysmo.

The uptake of Roche’s Vabysmo has been outstanding. RHHBY has designed Vabysmo to block pathways involving Ang-2 and VEGF-A. The European Commission also approved Vabysmo for these indications.

Regeneron is also looking to diversify its portfolio. The company acquired clinical-stage biotechnology company Decibel Therapeutics to expand its gene therapy programs for hearing loss.

Hence, the company should benefit from Dupixent’s continued label expansion and solid demand. The approval of Eylea HD is a massive boost for the company. REGN’s progress with the oncology portfolio is also impressive.

Regeneron currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the biotech sector is Ligand Pharmaceuticals (LGND - Free Report) , which currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Earnings estimates for Ligand Pharmaceuticals’ 2023 earnings per share have increased from $4.98 to $5.33 in the past 60 days. During the same period, earnings estimates for 2024 rose from $4.26 to $4.64.

Ligand beat earnings estimates in each of the last four quarters. The company delivered an earnings surprise of 67.19%, on average.
 

 

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