Moderna MRNA incurred a loss of $2.50 per share in the fourth quarter of 2024, narrower than the Zacks Consensus Estimate of a loss of $2.69. In the year-ago period, the company had reported earnings of 55 cents per share.

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Revenues in the fourth quarter were $966 million, which beat the Zacks Consensus Estimate of $956 million. However, total revenues declined around 64.3% year over year, owing to lower product sales.

In the past year, shares of Moderna have plunged 65% compared with the industry’s decline of 3.6%.

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More on MRNA's Q4 Earnings

Moderna currently has two marketed vaccines in its portfolio — the COVID-19 vaccine Spikevax and the recently launched respiratory syncytial virus (RSV) vaccine mResvia. Product sales were down 66.4% year over year to $938 million due to lower sales of Spikevax.

MRNA recorded $923 million from Spikevax sales in the fourth quarter of 2024 compared with $2.8 billion in the year-ago quarter. Per management, the decrease was primarily due to the earlier launch of the updated COVID-19 vaccine in the United States, which shifted sales into the third quarter.

Moderna recorded $15 million from mResvia sales in the fourth quarter. Last month at the J.P. Morgan Healthcare Conference, management stated that it expects minimal sales from the RSV vaccine, mResvia, in the quarter.

Please note that sales of Pfizer’s PFE RSV vaccine, Abrysvo, and GSK plc’s GSK RSV vaccine Arexvy also declined in the fourth quarter. This downtick can be attributed to the restrictive recommendation issued by the U.S. Centers for Disease Control and Prevention last year for individuals in the 60-74 age bracket.

PFE’s RSV vaccine Abrysvo is approved for older adults, as well as infants through maternal immunization. The vaccine is also approved for the prevention of lower respiratory tract disease (LRTD) caused by RSV in patients aged 18-59 who are at increased risk of the disease.

GSK’s Arexvy is currently approved for adults aged 60 and above for the prevention of LRTD caused by RSV. The vaccine is also approved for high-risk adults aged 50-59 years.

PFE’s Abrysvo generated sales worth $198 million while GSK’s Arexvy recorded sales of £158 million in the fourth quarter of 2024.

Moderna generated $28 million from grant, collaboration and licensing and royalty revenues in the fourth quarter compared with $18 million in the year-ago period. MRNA usually earns collaboration revenues from agreements with several big pharma/biotech companies, including Merck MRK and Vertex Pharmaceuticals.

Selling, general and administrative (SG&A) expenses were $351 million, down 25.3% year over year due to lower consulting costs.

Research & development (R&D) expenses were $1.12 billion, down 20% from the year-ago period’s levels due to lower spending on clinical studies and reduced manufacturing expenses.

MRNA's Full-Year Results

For 2024, Moderna generated revenues of $3.2 billion, which reflected a 52.9% decline year over year.

Last month, MRNA reported unaudited/preliminary product sales between $3 billion and $3.1 billion for 2024. This included more than $3 billion in COVID-19 vaccine sales and minimal sales from the RSV vaccine.

For the same period, the company reported a loss of $9.28 per share, narrower than a loss of $12.33 per share in the year-ago period.

MRNA's 2025 Guidance

The company reiterated its total revenue guidance for 2025, which it had provided last month.

MRNA expects total revenues in the range of $1.5-$2.5 billion, mainly from product sales of its COVID-19 and RSV vaccines. The Zacks Consensus Estimate is pegged at $2.30 billion.

Management expects to generate around $0.2 billion in revenues in the first half of the year, owing to the seasonality of its respiratory business.

The company expects full-year R&D expenses to be around $4.1 billion, while SG&A expenses are projected to be around $1.1 billion.

Capital expenditure is expected to be around $0.4 billion in 2025.

The company expects to end 2025 with cash, cash equivalents and investments of nearly $6 billion.

MRNA's Recent Pipeline Updates

The company 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 (the COVID-19 and influenza combination vaccine). A final decision from the FDA on mRNA-1283 is expected by May 31, 2025.

Management also submitted a biologics license application (BLA) seeking label expansion of mResvia for use in high-risk adults aged 18-59 years. The FDA has accepted the BLA and a decision is expected by June 12, 2025. At present, mResvia is approved for older adults aged 60 years and above.

With these product launches, management aims to boost the company’s revenues and reduce its dependence on the COVID-19 vaccine, which has been experiencing a significant decline due to lower vaccinations since the end of the pandemic.

Moderna has more than 40 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).

Moderna is co-developing mRNA-4157 with Merck. MRNA and MRK are evaluating mRNA-4157 in three pivotal phase III studies — one in melanoma indication and the other two for non-small cell lung cancer.

MRNA and MRK are also conducting phase II studies evaluating mRNA-4157 in renal cell carcinoma and muscle-invasive bladder cancer indications.

Moderna intends to start a registrational study on its methylmalonic acidemia therapeutic candidate mRNA-3705 later in 2025. This candidate was selected by the FDA for its Support for Clinical Trials Advancing Rare Disease Therapeutics pilot program to accelerate the development of novel therapies addressing unmet medical needs in rare diseases.

MRNA's Zacks Rank

Moderna 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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