Regeneron Pharmaceuticals, Inc. REGN reported first-quarter 2025 adjusted earnings per share (EPS) of $8.22, which missed the Zacks Consensus Estimate of $8.43. The reported figure was down 14% from $9.55 reported in the year-ago quarter. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)

The decline in the bottom line can be attributed to lower revenues and higher operating expenses.

Total revenues decreased 4% year over year to $3 billion due to lower sales of lead drug Eylea. Revenues also missed the Zacks Consensus Estimate of $3.27 billion. Sales of oncology drug, Libtayo, also missed estimates.

Shares are trading down in response to lower-than-expected results. Regeneron’s shares have lost 14.1% year to date compared with the industry’s decline of 4.7%.

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Eylea Pulls Down REGN’s Q1 Results

Eylea’s sales in the United States plunged 39% year over year to $736 million, primarily due to increased competition from other drugs like Roche’s RHHBY Vabysmo, loss in market share to compounded bevacizumab due to patient affordability constraints and transition of patients to higher doses of the drug (Eylea HD).

Please note that Regeneron co-developed Eylea with the HealthCare unit of Bayer AG BAYRY. Regeneron records net product sales of Eylea in the United States and Bayer does the same outside the country. The company records its share of profits in connection with Eylea sales outside the United States as collaboration revenues.

In August 2023, the FDA approved Eylea HD (higher dose of Eylea) for the treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy. Eylea HD generated revenues of $307 million in the United States. The figure surged 54% year over year, driven by the addition of new patients and the transition of patients from Eylea.

Total Eylea and Eylea HD sales in the United States were $1 billion, down 26% year over year. The figure missed the Zacks Consensus Estimate of $1.2 billion.

Total Eylea and Eylea HD product sales were negatively impacted by lower wholesaler inventory levels at the end of the first quarter of 2025 (compared to the previous quarter).

Total revenues include collaboration revenues of $1.53 billion from Sanofi SNY and Bayer. The figure increased 20.9% from that recorded in the year-ago quarter. Total collaboration revenues beat the Zacks Consensus Estimate of $1.5 billion.

Sanofi’s collaboration revenues increased 30% to $1.2 billion, driven by profits associated with higher Dupixent sales. The figure beat the Zacks Consensus Estimate of $1.1 billion. We note that Sanofi records global net product sales of Dupixent and Kevzara, while Regeneron records its share of profits/losses in connection with the global sales of both drugs. Dupixent’s sales increased 19% year over year to $3.7 billion.

Bayer’s collaboration revenues totaled $344 million, down 3% year over year.

Regeneron records net product sales of Praluent in the United States and Sanofi does the same outside the country. SNY pays REGN a royalty on such sales. Regeneron records global net product sales of Libtayo and pays Sanofi a royalty on such sales.

Total Libtayo sales were $285.1 million, up 8% year over year. The figure missed the Zacks Consensus Estimate of $346 million.  

Praluent’s net sales in the United States were $56.8 million. Kevzara recorded global sales of $116.4 million, up 24% from the year-ago quarter’s level.

Gross margin decreased to 85% from 89% due to higher inventory write-offs and reserves. Adjusted R&D expenses increased 6% year over year to $1.2 billion due to the advancement of the company's pipeline and higher headcount-related costs. Adjusted SG&A expenses decreased 8% to $537 million.

In February 2025, the board of directors authorized a new share repurchase program to repurchase up to an additional $3.0 billion of the common stock. During the first quarter of 2025, REGN repurchased shares for $1.052 billion. As of March 31, 2025, approximately $3.874 billion remained available for share repurchases.

In April 2025, REGN declared a cash dividend of $0.88 per share.

Key Pipeline and Regulatory Updates

The FDA approved a label expansion of Dupixent for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite antihistamine treatment.

In February 2025, the FDA accepted the supplemental biologics license application (sBLA) for Dupixent in bullous pemphigoid for priority review, with a target action date of June 20, 2025. A regulatory application has also been submitted in the European Union.

The FDA accepted (for priority review) an sBLA seeking approval of Eylea HD for the treatment of macular edema following RVO and for broadening the dosing schedule to include every four-week (monthly) dosing across approved indications. The target action date is August 19, 2025.

However, the regulatory body issued a complete response letter (CRL) for the Eylea HD pre-filled syringe. The CRL was mostly issued due to a third-party component supplier.

The FDA also issued a CRL to the sBLA for Eylea HD to add extended dosing intervals. The FDA indicated that the submitted data did not support extended dosing intervals greater than every 16 weeks.

The BLA seeking approval of odronextamab in relapsed/refractory (R/R) follicular lymphoma was resubmitted and the FDA accepted it for review with a target action date of July 30, 2025.

The FDA also accepted (for review) the resubmission of the BLA for linvoseltamab, a bispecific antibody targeting BCMA and CD3, in relapsed/refractory (R/R) multiple myeloma. The agency set a target action date of July 10, 2025.

The European Commission granted conditional marketing approval to linvoseltamab to treat adults with R/R multiple myeloma.  The drug was approved under the brand name Lynozyfic.

Our Take on REGN's Performance

Regeneron's performance in the first quarter was dismal. The plunge in Eylea sales adversely impacted the top line.

Eylea sales have been under pressure for some time now due to competition from Vabysmo. We note that Vabysmo's uptake has been outstanding. Roche designed Vabysmo to block pathways involving Ang-2 and VEGF-A.

Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise

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

In addition, Libtayo sales missed estimates.

Regeneron has a tough road ahead, as it will take a long time for Eylea HD to contribute significantly to the top line.

The company also suffered a few regulatory setbacks in its effort to broaden the oncology portfolio.

Meanwhile, Regeneron announced a 10-year agreement with Fujifilm Diosynth Biotechnologies to manufacture and supply Regeneron's commercial bulk drug product at Fujifilm's North Carolina campus. This agreement is anticipated to nearly double REGN’s large-scale manufacturing capacity in the United States.

The decision follows President Trump's announcement of (potential) trade tariffs on pharmaceutical imports.

Zacks Rank

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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This article originally published on Zacks Investment Research (zacks.com).

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