Moderna Inc. (MRNA) delivered some welcome news on Friday, reporting fourth-quarter results that beat analyst expectations on both the top and bottom lines. The COVID-19 vaccine maker posted a loss of $2.11 per share, narrower than the expected $2.59 loss and better than the $2.91 loss from a year earlier.

Revenue came in at $678 million, topping forecasts of $626.1 million. That figure landed at the higher end of the company's own projections, driven primarily by COVID vaccine sales. The geographic breakdown showed $264 million in U.S. product sales and $381 million from international markets. Still, total fourth-quarter revenue dropped 30% year over year, reflecting the reality that COVID vaccine demand has settled into a new, lower baseline compared to the pandemic era.

CEO Stéphane Bancel struck an optimistic tone about the company's operational progress. "In 2025, we sharpened our commercial execution, launched our third product, and brought online three international manufacturing sites, while advancing our mRNA pipeline," Bancel said. "At the same time, we lowered our annual operating expenses by approximately $2.2 billion, significantly surpassing our cost-reduction targets."

Looking ahead, Bancel added that the company 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."

Growth Plans and Financial Projections

Moderna's 2026 guidance calls for up to 10% revenue growth from the $1.94 billion recorded in 2025, which would put revenue around $2.13 billion. The company expects roughly equal contributions from U.S. and international markets, a notable shift as it diversifies away from domestic dependence.

On the expense side, Moderna projects cost of sales around $900 million for 2026, with R&D spending hitting approximately $3.0 billion and selling, general, and administrative expenses coming in at about $1.0 billion. The company expects to close out 2026 with cash and investments between $5.5 billion and $6.0 billion.

During the J.P. Morgan Healthcare conference, management outlined plans to further trim operating expenses to $4.2 billion to $4.6 billion in 2027, staying on track toward their targeted cash breakeven in 2028.

The FDA Flu Vaccine Setback

But here's where things get complicated. Earlier in the week, Moderna received a refusal-to-file letter from the FDA regarding its investigational influenza vaccine, mRNA-1010. The FDA's Center for Biologics Evaluation and Research declined to even begin reviewing the biologics license application, citing a single issue: Moderna's choice of comparator vaccine in its clinical trial.

Specifically, the FDA took issue with Moderna's use of a standard-dose seasonal flu vaccine as the control. The agency later clarified that Moderna should have used a higher-dose flu vaccine for older participants, particularly those aged 65 and above who face elevated risks from severe flu complications.

Moderna had used GSK plc's (GSK) Fluarix Quadrivalent in trial participants aged 65 and older. While Fluarix Quadrivalent is FDA-approved, it's not among the flu shots recommended by the Centers for Disease Control and Prevention for this age group, where high-dose vaccines are the standard of care.

What This Means for Moderna's Future

Analysts at William Blair characterized the refusal-to-file letter as "a big hit to the company's vaccine franchise" and its prospects of achieving breakeven guidance in 2028. Analyst Myles Minter noted that this development represents "a substantial hit to the probability of success for mRNA-1010, and in turn, mRNA-1083's (combo flu/COVID vaccine) U.S. approvability."

The stakes are significant. William Blair had modeled peak U.S. sales for mRNA-1010 at over $1 billion in an annual market worth roughly $5 billion. The firm also expected that mRNA-1083, the combination flu and COVID vaccine, would help restore growth to Moderna's COVID-19 vaccine franchise in the U.S. Both products were expected to be meaningful revenue contributors in 2027 and 2028, respectively.

With those projections now in doubt, Moderna faces tougher math in its journey back to profitability. The company can resubmit its flu vaccine application with revised trial data, but that takes time and adds uncertainty to what was supposed to be a clear path forward.

Despite the flu vaccine setback, investors seemed to focus on the positive fourth-quarter results and 2026 growth outlook. Moderna shares climbed 7.58% to $43.15 on Friday.