At the J.P. Morgan Healthcare Conference, Moderna MRNA announced several financial updates on its business and updates on its pipeline progress.
Moderna reported unaudited/preliminary product sales between $3 billion and $3.1 billion for 2024. This includes more than $3 billion in COVID-19 vaccine sales and minimal sales from the RSV vaccine mResvia. This figure was mainly toward the lower end of the company’s previously issued guidance of $3.0-$3.5 billion.
Management expects to close the year with cash, cash equivalents and investments of around $9.5 billion. Full details for the fourth quarter and full year 2024 will be provided on the company’s earnings call on Feb. 14.
Moderna reduced its previously announced sales guidance for 2025 by $1 billion. It now forecasts total revenues in the range of $1.5 to $2.5 billion, mainly from product sales of its COVID-19 and RSV vaccines. Management expects to generate the majority of this figure in the second half of the year.
Shares of Moderna were down nearly 17% on Monday, likely due to the guidance cut. This revised guidance fell significantly below Wall Street expectations. The Zacks Consensus Estimate for 2025 revenues is $2.94 billion.
In the past year, the stock has plunged nearly 67% compared with the industry’s 16.3% fall.
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Alongside the guidance update, management also announced that it is accelerating and expanding its recently implemented portfolio prioritization and cost efficiencies program. Based on this expansion, it now expects cash cost reductions of $1 billion this year and also expects to save an additional $0.5 billion in costs next year.
The company expects to end 2025 with cash, cash equivalents and investments of nearly $6 billion.
Moderna reiterated its stance to launch 10 new marketed products over the next three years. To achieve this goal, management submitted three regulatory filings seeking the FDA’s approval. This includes fresh regulatory filings for mRNA-1283 (next-generation COVID-19 vaccine) and mRNA-1083 (COVID-19 and influenza combination vaccine). A final decision on mRNA-1283 is expected by May 31, 2025. Management also submitted a regulatory filing for mResvia seeking label expansion for use in high-risk adults aged 18-59 years.
Though management did not disclose any hard numbers, it announced that an independent data safety monitoring board (DSMB) has stated that the pivotal late-stage CMVictory study on Moderna’s CMV vaccine did not meet the criteria for early efficacy. However, the DSMB has recommended the study to continue. Final data from this study is expected later this year.
Moderna is also evaluating its influenza and norovirus vaccines in separate phase III studies. It expects efficacy data from both studies later this year if sufficient cases are accrued in the first season; if not, then the study will continue to a second season.
Management is also developing mRNA-4157, an investigational individualized neoantigen therapy, in partnership with Merck MRK. MRNA/MRK are evaluating mRNA-4157 in two pivotal phase III studies for melanoma and non-small cell lung cancer indications. Last year, Moderna/Merck started three new clinical studies evaluating mRNA-4157 across cutaneous squamous cell carcinoma, renal cell carcinoma and muscle-invasive bladder cancer indications. The companies intend to focus on the late-stage studies evaluating the therapy.
While management started generating pivotal data from a phase I/II study on its propionic acidemia therapy in 2024, it intends to start a registrational study on its methylmalonic acidemia therapy in the first half of 2025.
Moderna currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the sector are Castle Biosciences CSTL and CytomX Therapeutics CTMX, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Bottom-line estimates for Castle Biosciences have improved from a loss of 8 cents per share to earnings of 34 cents for 2024 in the past 60 days. During the same timeframe, loss per share estimates for 2025 have narrowed from $1.88 to $1.84. In the past year, shares of Castle Biosciences have surged nearly 31%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 13 cents to 5 cents. Estimates for 2025 loss per share have narrowed from 46 cents to 35 cents during the same timeframe. CTMX’s shares have lost 49% in the past year.
CytomX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.
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