Regeneron to Report Q1 Earnings: What's in Store for the Stock?

Biotech giant Regeneron Pharmaceuticals, Inc. REGN is slated to report first-quarter 2025 results on April 29, 2025.

The Zacks Consensus Estimate for revenues is pegged at $3.25 billion, while the same for earnings is pinned at $8.76 per share. (Find the latest earnings estimates and surprises on Zacks Earnings Calendar.)

REGN’s Earnings Surprise History

The company’s earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 3.23%. In the last reported quarter, REGN beat on earnings by 3.87%.

What Our Model Predicts for REGN

Our proven model does not conclusively predict an earnings beat for Regeneron this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. That is not the case here, as you will see below.

Earnings ESP: Earnings ESP for REGN is -0.94% as the Zacks Consensus Estimate is pegged at $8.76 per share while the Most Accurate Estimate is pinned at $8.87. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter.

Zacks Rank: The company currently carries a Zacks Rank #4 (Sell).

Dupixent Profits Likely Offset Eylea Sales Decline in Q1

A significant chunk of Regeneron’s revenues comes from the sale of its lead drug, Eylea, which is approved for various ophthalmology indications (neovascular age-related macular degeneration, diabetic macular edema [DME] and macular edema, among others). Eylea was developed in collaboration with pharma giant Bayer.

While Regeneron records net product sales of Eylea in the United States, Bayer does the same outside the United States. The company also records its share of profits/losses in connection with Eylea sales outside the country.

Eylea’s sales were under pressure in recent quarters due to competition from Vabysmo. Sales are likely to have declined in the first quarter as well.

To counter the decline in Eylea sales, Regeneron developed a higher dose of the drug. The initial uptake of Eylea HD has been strong as Eylea patients transition to the higher dose.

Sales of Eylea HD have likely surged in the to-be-reported quarter on strong demand. This, in turn, might have resulted in an increase in total Eylea franchise sales.

The Zacks Consensus Estimate of Eylea sales in the United States is currently pegged at $1.2 billion.

Apart from Eylea, profits from the sales of asthma drug Dupixent are a primary growth driver for REGN. Regeneron has a collaboration agreement with Sanofi for drugs like Dupixent and Kevzara. While Sanofi records sales, Regeneron registers its share of profits/losses in connection with the global sales of the aforementioned drugs.

Dupixent sales have likely surged, driven by continued strong prescription trends in atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis. The recent label expansion of the drug in the COPD indication has likely boosted sales further. Hence, Regeneron must have earned incremental profits from Dupixent in the to-be-reported quarter.

The Zacks Consensus Estimate for Dupixent’s sales is currently pegged at $3.7 billion.  

Meanwhile, Regeneron is also looking to diversify its revenue base to reduce its dependence on Eylea for top-line growth and build an oncology franchise, which currently comprises Libtayo.

Growth in Libtayo’s sales has also boosted the top line in recent quarters. Libtayo sales are being driven by growth in demand for non-melanoma skin indications, coupled with increased utilization in both monotherapy and chemotherapy combination settings in lung cancer.  The Zacks Consensus Estimate for Libtayo’s sales is currently pegged at $346 million.

REGN is currently working to expand Libatyo’s label, in combination with other compounds, in additional indications.

REGN’s oncology franchise received a boost with the European Commission'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 after two or more lines of systemic therapy. The drug has been approved under the brand name Ordspono.

Operating expenses have also likely increased in the quarter due to pipeline advancement and higher commercialization-related expenses to support the launch of Eylea HD and higher headcount-related costs.

In February 2025, Regeneron initiated a quarterly cash dividend program and declared a dividend of $0.88 per share. The board also authorized an additional $3.0 billion share repurchase program, bringing the total current authorization to approximately $4.5 billion. Investors will look forward to updates on the share buyback program.

Other Updates From REGN

Stockholders will also look for key pipeline and regulatory updates from Regeneron, apart from the top and bottom-line numbers.

The FDA recently approved a label expansion of Dupixent for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria who remain symptomatic despite histamine-1 (H1) antihistamine treatment.

However, the FDA has issued a complete response letter (CRL) regarding the supplemental biologics license application (sBLA) for the addition of extended dosing intervals (up to every 24 weeks) for Eylea HD injection 8 mg across all approved indications.

The CRL did not identify any issue with the safety or efficacy of Eylea HD in its approved indications and dosing regimens. The FDA did not agree with Regeneron’s proposal to add additional extended dosing intervals (greater than every 16 weeks, which is the maximum dosing interval currently indicated in the label).

Nonetheless, the FDA accepted the sBLA for Eylea HD injection 8 mg. The sBLA seeks approval for Eylea HD to treat macular edema following retinal vein occlusion (RVO) and broaden the dosing schedule to include every 4 weeks (monthly) dosing across approved indications. The regulatory body set a target action date of Aug. 19, 2025, following the use of a Priority Review voucher.

REGN’s Share Price Performance

Regeneron’s shares have lost 21.1% year to date compared with the industry’s decline of 7.8%.

Stocks to Consider

Here are some drug/biotech stocks that have the right combination of elements to beat on earnings this time around:

Vertex Pharmaceuticals VRTX has an Earnings ESP of +1.49% and a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

VRTX beat on earnings in two of the trailing four quarters and missed in the remaining two, the average surprise being 2.58%. The company will report first-quarter results on May 5, 2025.

Gilead Sciences, Inc. GILD has an Earnings ESP of +3.07% and a Zacks Rank of 3 at present. GILD beat on earnings in each of the trailing four quarters, delivering an average surprise of 19.47%. The company is scheduled to report first-quarter results on April 24, 2025.

AstraZeneca AZN has an Earnings ESP of +2.73% and a Zacks Rank #3 at present. AZN is scheduled to release first-quarter results on April 29, 2025. AstraZeneca beat on earnings in three of the trailing four quarters and missed in the remaining one, the average surprise being 3.16%.

 

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

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