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Moderna (MRNA) to Report Q3 Earnings: What's in the Cards?

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Moderna, Inc. (MRNA - Free Report) will report third-quarter 2021 results on Nov 4, before market open. In the last reported quarter, the company delivered an earnings surprise of 7.49%.

Moderna’s share price has surged 230.4% so far this year against the industry’s decrease of 9.9%.

Zacks Investment ResearchImage Source: Zacks Investment Research

The company’s surprise history has been mixed so far with its earnings beating estimates in two of the trailing four quarters while missing the same twice. The average negative surprise is 41.63%.

Let’s see how things have shaped up for this announcement.

Factors to Note

Moderna’s top line is likely to have been driven by the strong uptake of its COVID-19 vaccine, mRNA-1273 during the third quarter. We expect the rising demand for the company’s COVID-19 vaccine doses to have continued in the third quarter. Quarterly product sales are likely to have increased significantly, sequentially. The Zacks Consensus Estimate for product sales for the soon-to-be reported quarter stands at $5.69 billion.

During the quarter, the company received authorization for mRNA-1273 in India and Australia. The vaccine received an emergency use listing from the World Health Organization. Moreover, the label of mRNA-1273 was expanded to include adolescents in Europe and Japan during the quarter. In August, the FDA authorized a third dose of mRNA-1273 to be administered in immunocompromised adults. These factors are likely to have boosted product sales during the third quarter.

Last month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the use of the booster dose of mRMA-1273 in people aged 18 years and older at least six months after completion of the primary series. The company may provide a timeline for EMA authorization for the same on the earnings call.

The FDA notified Moderna last week that it will require additional time to review the company’s emergency use authorization (EUA) request for the use of mRNA-1273 in adolescents 12 to 17 years of age. The additional time is required to evaluate recent international analyses of the risk of myocarditis after vaccination. The FDA stated that the review may not be completed before January 2022. We note that Moderna has successfully completed a pivotal study of mRNA-1273 in children 6 to under 12 years of age. However, the company decided to delay filing a request for EUA in this population, following the FDA’s notification for additional time for review of the EUA for the adolescent population.

Investors are likely to ask questions on the impact of delay in authorization for the use of mRNA-1273 in additional population on the company’s top line and competition.

Moderna’s grant revenues are likely to have been driven by award from the Biomedical Advanced Research and Development Authority (“BARDA”) under the agreement to develop its coronavirus vaccine program in 2021. The Zacks Consensus Estimate for grant revenues is pegged at $82 million.

Apart from its COVID-19 vaccine candidates, Moderna is developing several other mRNA-based products targeting different indications, including cancer. The company has collaborations with partners like AstraZeneca (AZN - Free Report) and Merck (MRK - Free Report) , which use its mRNA technology to develop therapies targeting different indications. The partners pay milestone payments to Moderna, which are reflected as collaboration revenues. These collaborations revenues vary every quarter. The Zacks Consensus Estimate for collaboration revenues for the third quarter is pegged at $19 million.

What Does Our Model Say?

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. But that is not the case here.

Earnings ESP: Earnings ESP, which represents the difference between the Most Accurate Estimate of $8.41 per share and the Zacks Consensus Estimate of $9.01, is -6.69%. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.

Zacks Rank: Moderna has a Zacks Rank #3.

Moderna, Inc. Price and EPS Surprise

Moderna, Inc. Price and EPS Surprise

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

Stock to Consider

Here is a biotech stock that has the right combination of elements to beat on earnings this time around:

Regeneron Pharmaceuticals (REGN - Free Report) has an Earnings ESP of +8.78% and a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank stocks here.

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