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Regeneron (REGN) Faces Challenges as Eylea Sales Decline

Regeneron Pharmaceuticals, Inc. REGN lost 6.3% in a month compared with the industry’s decline of 2.8%.

Earlier in the month, Regeneron delivered better-than-expected first-quarter 2023 results. However, lead drug Eylea (aflibercept) sales declined. Shares declined in response to the same.

Lead drug Eylea’s sales in the United States were $1.4 billion, down 6% year over year, primarily due to an increase in sales-related deductions. Please note that Regeneron co-developed Eylea with the HealthCare unit of Bayer AG BAYRY.

Regeneron’s lead drug, Eylea, is approved for various ophthalmology indications and has been a consistent performer, but sales are under pressure due to increasing competition from Roche’s RHHBY Vabysmo.

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In January 2022, Roche won FDA approval for Vabysmo (faricimab-svoa) to treat wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A. The European Commission also approved Vabysmo (faricimab) for these indications.

Regeneron records net product sales of Eylea in the United States and Bayer records net product sales of Eylea outside the United States. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States.

On a positive note, the FDA accepted the biologics license application (BLA) for the priority review of aflibercept 8 mg for treating patients with wet AMD, DME and diabetic retinopathy, with a target action date of Jun 27, 2023.

A regulatory application has also been submitted for treating wet AMD and DME in the European Union (EU) and Japan. Regeneron is now focused on the potential launch of aflibercept 8 mg following a tentative approval.

Shares of Regeneron are still up 5.4% in the year so far against the industry’s decline of 7.8%.

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Regeneron’s top line is being boosted by its share of profits/losses in connection with global sales of Dupixent. Its partner, Sanofi SNY, records global net product sales of Dupixent. Dupixent maintains its dominant position, driven by continued strong demand in the approved indications, atopic dermatitis (AD), asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis and prurigo nodularis.

Regeneron also records net product sales of Praluent in the United States and Sanofi records net product sales of Praluent outside the United States and pays the company a royalty on such sales.

Both companies recently announced that the U.S. Supreme Court ruled against Amgen, ending a nearly decade-long patent dispute related to Praluent.  The decision affirms the United States Court of Appeals for the Federal Circuit’s opinion, which held that Amgen’s asserted U.S. PCSK9 patent claims were invalid.

Meanwhile, Regeneron is also looking to diversify in the lucrative oncology space with Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer.

Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report

Sanofi (SNY) : Free Stock Analysis Report

Roche Holding AG (RHHBY) : Free Stock Analysis Report

Bayer Aktiengesellschaft (BAYRY) : Free Stock Analysis Report

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