News

Moderna, Inc. MRNA reported earnings of 55 cents per share in the fourth quarter of 2023, beating the Zacks Consensus Estimate of a loss of 78 cents. Earnings declined 85% in the quarter. The year-over-year decline in the bottom line was due to lower product sales during the quarter.

Revenues in the quarter were $2.81 billion, beating the Zacks Consensus Estimate of $2.55 billion. Total revenues declined 45% year over year due to lower COVID-19 vaccine sales during the quarter.

Moderna’s shares were up 6.1% in pre-market trading on Feb 22, likely due to the better-than-expected earnings reported by the company. Investors were expecting the company to report a loss in the fourth quarter. However, the company’s positive earnings in the quarter took the investor community by surprise. The better-than-expected earnings performance was driven by lower-than-expected operating expenses incurred by the company during the quarter.

Year to date, the stock has lost 11.9% compared with the industry’s 1.1% fall.

Image Source: Zacks Investment Research

Quarter in Detail

Product sales, entirely from the sale of COVID-19 vaccines, were down 43% year over year to $2.79 billion due to lower sales volume compared with the year-ago period’s levels.

During the fall 2023 COVID season, management claims to have expanded its cumulative market share in the United States to 48%, compared with 37% in 2022.

Grant and collaboration revenues were $18 million compared with $225 million in the year-ago quarter. The company earns collaboration revenues from agreements with several big pharma/biotech companies, including Merck MRK and Vertex Pharmaceuticals.

Selling, general and administrative expenses were $470 million, up 25% year over year. The upside can be primarily attributed to increased spending in employee-related costs and other commercial and marketing expenses.

Research & development expenses were $1.4 billion, up 16% from the year-ago period’s levels. The upside can be primarily attributed to increased clinical manufacturing activities incurred during the quarter.

Full-Year Results

Moderna reported revenues of $6.8 billion for 2023, down 64% year over year.

For the full year, the company reported a loss of $12.33 per share against earnings of $20.12 in 2022.

2024 Guidance

Moderna reiterated its product revenue guidance for 2024. Moderna expects to generate around $4 billion in product revenues, driven mainly by sales of its COVID-19 vaccine and the launch of its RSV vaccine.

Management also maintained full-year R&D expenses of around $4.5 billion and SG&A expenses of approximately $1.3 billion. It expects capital expenditure to be around $0.9 billion and end 2024 with cash balance of around $9 billion.

Pipeline & Other Updates

The company has 45 mRNA-based investigational candidates in different stages of clinical studies, targeting various indications, including cancer. Moderna is evaluating multiple candidates in late-stage studies — mRNA-1647 [cytomegalovirus (CMV) vaccine], mRNA-1010 (influenza vaccine), mRNA-4157/V940 [individualized neoantigen therapy (INT)] and mRNA-1083 (COVID-19 plus influenza combination vaccine).

mRNA-1345, Moderna’s RSV vaccine, is currently under the FDA’s review for use in older adults (aged 60 years and older). A final decision is expected before May 12, 2024. If the outcome is positive, a CDC advisory committee could also recommend using the vaccine in its meeting in June.

Last year during the third quarter, Moderna reported encouraging data from a phase III immunogenicity study (P303) and a separate phase I/II head-to-head study evaluating an enhanced formulation of flu vaccine mRNA-1010. Participants treated with mRNA-1010 elicited higher immune responses across all four A and B strains of influenza compared to the vaccines marketed by GSK and Sanofi. Management is in ongoing discussions with regulators and intends to start seeking regulatory approvals later this year.

Management intends to report several data readouts this year. This includes data from pivotal late-stage studies on mRNA-1283, the company’s next-generation refrigerator-stable COVID-19 vaccine, mRNA-1083, and mRNA-1647. While data on mRNA-1283 is expected in the first half of 2024, data from clinical studies on mRNA-1083 and mRNA-1647 are expected by 2024-end.

The company’s INT therapy, mRNA-4157, is being co-developed with Merck. After the companies reported that the INT therapy achieved its primary and key secondary endpoints in a phase IIb study in the first half of 2023, two pivotal phase III studies were initiated in the second half of 2023 evaluating the vaccine in melanoma and non-small cell lung cancer (NSCLC) indications. Moderna and Merck intend to start clinical studies in additional tumor types later this year.

Moderna, Inc. Price

Zacks Rank & Key Picks

Moderna currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Adicet Bio ACET and Puma Biotechnology PBYI. While Puma Biotechnology sports a Zacks Rank #1 (Strong Buy) at present, Adicet carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have risen from 72 cents to 73 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 64 cents to 71 cents. Year to date, shares of PBYI have rallied 50.4%.

Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on one occasion. Puma delivered a four-quarter average earnings surprise of 76.55%.

In the past 60 days, estimates for Adicet Bio’s 2024 loss per share have improved from $2.11 to $1.81. Year to date, shares of ACET have surged 42.3%.

Earnings of Adicet Bio beat estimates in two of the trailing four quarters while missing the mark on the other two occasions. On average, Adicet came up with a four-quarter negative earnings surprise of 8.36%.

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