Moderna Inc. (NASDAQ:MRNA) on Friday reported a fourth-quarter loss of $2.11, beating the expected loss of $2.59, lower than a loss of $2.91 a year ago.
The COVID-19 vaccine maker reported quarterly sales of $678 million, topping the expected $626.097 million.
Total revenue was on the higher end of the company’s prior expectations and was driven primarily by COVID vaccine sales.
Product sales were $264 million in the U.S. and $381 million in international markets. Fourth quarter revenue decreased 30% year over year, primarily reflecting lower COVID vaccine sales volume compared to the prior-year period.
“In 2025, we sharpened our commercial execution, launched our third product, and brought online three international manufacturing sites, while advancing our mRNA pipeline. At the same time, we lowered our annual operating expenses by approximately $2.2 billion, significantly surpassing our cost-reduction targets,” said Stéphane Bancel, CEO of Moderna.
“We entered the new year with strong momentum despite the continued challenging environment in the U.S., poised to deliver up to 10 percent revenue growth through mNEXSPIKE expansion and our international strategic partnerships,” Bancel said on Friday.
Outlook
Turning to guidance, Moderna is targeting up to 10% revenue growth from $1.94 billion in 2025 and expects the 2026 revenue split to be approximately 50% U.S. and approximately 50% international.
Cost of sales for 2026 is expected to be approximately $0.9 billion, with R&D expenses of approximately $3.0 billion, and SG&A expenses of approximately $1.0 billion.
Year-end cash and investments for 2026 are projected to be $5.5 to $6.0 billion.
Analyst View On Refusal To File Letter
On Wednesday, Moderna faced a setback following a refusal-to-file letter from the U.S. Food and Drug Administration (FDA) regarding its investigational influenza vaccine, mRNA-1010.
The FDA’s Center for Biologics Evaluation and Research (CBER) notified Moderna that it would not initiate a review of the biologics license application for mRNA-1010, citing the choice of a standard-dose seasonal influenza vaccine as a comparator as the sole reason for the refusal.
William Blair on Wednesday wrote that the RTF letter for mRNA-1010 represents a big hit to the company’s vaccine franchise and its prospect of achieving its breakeven guidance in 2028.
During the JP Morgan Healthcare conference, Moderna said it expects to further reduce operating expenses to $4.2 – $4.6 billion in 2027, on the path to targeted cash breakeven in 2028.
Analyst Myles Minter wrote that this is a substantial hit to the probability of success for mRNA-1010, and in turn, mRNA-1083’s (combo flu/COVID vaccine) U.S. approvability.
U.S. sales of these products were expected to be meaningful contributors to 2027 and 2028 revenue, respectively, and William Blair modeled peak U.S. mRNA-1010 sales of greater than $1 billion in a ~$5 billion annual market and that mRNA-1083 would return the COVID-19 vaccine franchise to growth in the U.S
The FDA later defended its decision, stating that Moderna should have used a higher-dose flu vaccine for older participants in the control arm of its trial.
The agency raised concerns over the use of GSK plc’s (NYSE:GSK) Fluarix Quadrivalent in participants aged 65 and older — a group at elevated risk of severe flu complications and for whom high-dose vaccines are available.
While Fluarix Quadrivalent is FDA-approved, it is not among the flu shots recommended by the Centers for Disease Control and Prevention for this age group.
MRNA Price Action: Moderna shares were up 7.58% at $43.15 at the time of publication on Friday, according to Benzinga Pro data.
Photo by Wolfilser via Shutterstock
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