Moderna expects up to $3.5 billion in 2025 sales
By Patrick Wingrove
Sept 12 (Reuters) -Moderna MRNA.O on Thursday said it expects sales of between $2.5 billion and $3.5 billion next year, and forecast that new product launches would drive an average annual growth rate of 25% in revenue between 2026 and 2028.
The vaccine maker last month projected sales of $3 billion and $3.5 billion for this year, which will be its lowest annual revenue since Moderna launched its COVID-19 vaccine in late 2020 - the company's first commercial product.
Analysts on average expect the company will generate revenue of $3.27 billion and $3.74 billion for 2024 and 2025, respectively, according to LSEG data.
The company said last year it expected to return to sales growth in 2025.
Moderna Chief Financial Officer James Mock said next year's forecast reflects the uncertainty of the COVID and respiratory syncytial virus (RSV) markets in the U.S., as well as Moderna's prediction that the 10 new products it expects to be approved by 2027 will start to generate meaningful revenue in 2028.
"For 2025, we might have some new product approvals assumed, but there's not assumed to be much revenue from them," he said.
The Cambridge, Massachusetts-based company has been banking on revenue from newer mRNA shots, including its RSV vaccine mRESVIA, to make up for declining revenue from its COVID shot since the end of the pandemic.
Moderna said it plans to submit an application to the U.S. Food and Drug Administration this year to expand approval for its RSV shot to high-risk adults under the age of 60, following new data from a late-stage trial.
The FDA approved Moderna's mRESVIA shot for RSV-associated lower respiratory tract disease in adults aged 60 or older last May, pitting it against rival vaccines from GSK GSK.L and Pfizer PFE.N.
The company also said it had dropped its request for fast-track approval as part of its application to the FDA for a standalone influenza vaccine. It instead will focus on the application for its combination shot to protect against both COVID and influenza, which it plans to submit this year.
Moderna said mRESVIA met all immune-response targets and was found to be safe and well tolerated in adults aged 18 and older with a compromised immune system, but did not provide further details on the new study's findings.
Pfizer said in August that its Abrysvo shot, which was approved last year for adults over the age of 60, generated a strong immune response in high-risk adults aged 18 and older.
The FDA in June expanded the use of GSK's Arexvy vaccine in adults between the ages of 50 and 59. The U.S. Centers for Disease Control and Prevention the same month instead recommended RSV shots be given to all adults 75 and older, as well as those who are 60 to 74 and have an increased risk of severe RSV due to medical conditions.
Moderna also said its standalone flu vaccine met immune-response targets when compared to GSK's Fluarix in a new study, as well as across all strains of the flu in an extension study for older adults compared to Sanofi's SASY.PA Fluzone HD.
It plans to launch an efficacy study for the flu vaccine this year.
Reporting by Patrick Wingrove in New York; Editing by Bill Berkrot
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