Moderna MRNA is expected to report first-quarter 2025 earnings on May 1, before the opening bell. The company’s earnings beat estimates by 7.06% in the last reported quarter. The Zacks Consensus Estimate for sales and earnings is pegged at $127 million and a loss of $2.91 per share, respectively. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)

Factors Shaping MRNA’s Upcoming Results

The company is likely to have generated a major portion of its revenues from selling its COVID-19 vaccine. Our model estimate for the vaccine’s sales is pegged at $112 million, implying a significant decline from the year-ago level due to lower demand.

We expect minimal product sales of the company's RSV vaccine mResvia, which received FDA approval last year. Our model estimate for this vaccine’s sales is pinned at $10 million. This number is significantly low when compared to the sales of currently marketed RSV vaccines Arexvy and Abrysvo, marketed by pharma giants GSK and Pfizer, respectively. The softer sales expectation is likely due to the vaccine being approved and recommended later in the contracting season. By that time, many customers must have already completed their orders.

Moderna submitted three regulatory filings to the FDA in the fourth quarter of 2024. These included filings seeking FDA approval for mRNA-1283 (the next-generation COVID-19 vaccine) and mRNA-1083 (COVID-19 plus influenza combination vaccine). A final decision on mRNA-1283 is expected by May 31. MRNA also submitted a regulatory filing seeking label expansion of mResvia for use in high-risk adults aged 18-59, a final decision for which is expected by June 12. At present, mResvia is approved for older adults aged 60 years and above. Investors would be keen to hear updates on the regulatory progress of these filings, including any feedback or requests for additional data from the FDA, during the upcoming earnings call.

The company is developing more than 40 mRNA-based investigational candidates in different stages of clinical studies, targeting various indications, including cancer. It is evaluating multiple candidates in late-stage studies — mRNA-4157/V940 [individualized neoantigen therapy (INT)], mRNA-1647 [cytomegalovirus (CMV) vaccine], mRNA-1010 (influenza vaccine) and mRNA-1403 (norovirus vaccine).

An important candidate garnering investor attention is mRNA-4157, which is being developed in collaboration with Merck MRK. Moderna and Merck are evaluating mRNA-4157 in three pivotal phase III studies — one in the melanoma indication and the other two in the non-small cell lung cancer space.

Since the onset of 2024, Moderna and Merck have also started three new clinical studies evaluating mRNA-4157 in cutaneous squamous cell carcinoma, renal cell carcinoma and muscle-invasive bladder cancer indications. Investors would likely seek an update from the company on the cancer therapy’s progress across these studies.

MRNA’s Earnings Surprise History

The biotech firm’s performance has been impressive over the past four quarters. Its earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 31.79%.

Moderna, Inc. Price and EPS Surprise

Moderna, Inc. price-eps-surprise | Moderna, Inc. Quote

Year to date, Moderna’s shares have lost 34% compared with the industry’s 6% decline.

Image Source: Zacks Investment Research

What Our Model Predicts for MRNA

Our proven model does not conclusively predict an earnings beat for Moderna 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. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.

Moderna has an Earnings ESP of -8.13% and a Zacks Rank #3 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Stocks to Consider

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

argenx ARGX has an Earnings ESP of +10.92% and a Zacks Rank #2 at present.

argenx stock has lost 2% year to date. It beat on earnings in two of the last four quarters and missed in the other two, delivering an average surprise of 345.11%.

CytomX Therapeutics CTMX has an Earnings ESP of +38.89% and a Zacks Rank #2 at present.

CytomX Therapeutics’ shares have plunged 26% year to date. CytomXbeat on earnings in three of the trailing four quarters and missed in the other one, delivering an average surprise of 180.70%.

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

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