Moderna will not commit to previous 2028 breakeven guidance as the ripple effects of the FDA’s refusal-to-file decision spread through its pipeline.
Moderna executives didn’t mention the word “breakeven” while reporting fourth quarter earnings—until analysts asked. Having previously said the company would reach that key milestone in 2028, Moderna’s management now admits that the plan has been blown wide open by the FDA’s decision to not even look at an application for the influenza vaccine mRNA-1010.
So will the company make it after a potential $1 billion revenue opportunity has been potentially scuppered? CFO Jamey Mock said there are just too many unknowns at this point, just five days after the FDA’s surprise decision landed with a thud on Moderna’s desk.
“I recognize that it’s on investors’ minds,” Mock started off, speaking on the company’s earnings call Friday morning. “This is a bit of a fresh and fluid situation, and without understanding the resolution of what is next for our flu product, it’s a little bit difficult to comment at this time.”
Without restating the breakeven goal, Mock said that Moderna is expecting 10% topline revenue growth for 2026 thanks to vaccine contracts outside of the U.S.
Mock also pointed to 10 upcoming products in Moderna’s pipeline that are expected to start contributing revenue in the next few years. “We have 10 large shots on goal to increase revenue over the coming years, all with a wide range of potential outcomes,” he said.
But Moderna has to contend with the FDA, which has been showing hostility toward the company’s key mRNA technology and vaccines. Later on the call, an analyst probed Moderna executives for whether the same office that rejected mRNA-1010 will be in charge of the application for personalized cancer vaccine intismeran autogene (INT), which is being developed with Merck.
Moderna President Stephen Hoge, who leads the R&D organization, confirmed that yes, the FDA’s Center for Biologics Evaluation and Research would be in charge of the application for INT. CBER chief Vinay Prasad personally signed off on the refusal-to-file letter regarding mRNA-1010, reportedly overruling other regulators.
Hoge said that while CBER would certainly be the lead office, others would be involved too. “It is an oncology therapy of high import. It gets a lot of attention,” Hoge said.
He stressed that conversations have been going well so far with “highly productive engagement.”
Merck is heavily involved in INT’s development, according to the split laid out in the original licensing deal. The Big Pharma is running the Phase 3 trial for the therapy in melanoma, and a biologics license agreement, “if it goes forward,” will be Merck’s responsibility. Hoge gave no indication that they will change any other leadership aspect of the regulatory process.
The readout for the Phase 3 INTERPATH-001 trial in melanoma is due this year. Other trials in the partnership include Phase 2 tests for adjuvant renal cell carcinoma and adjuvant muscle-invasive bladder cancer.
Moderna does intend to refile the mRNA-1010 vaccine in the U.S., pending feedback from the FDA, CEO Stéphane Bancel said on the call. But for now, the company is eyeing other markets like Europe, Canada and Australia for approvals.
Bancel only delivered prepared remarks during the call and left the analyst questions to his deputies. But he reiterated his disappointment in the FDA’s RTF decision.
“The current uncertainty in the U.S. FDA regulatory environment creates real challenges for businesses, patients and the broader innovation ecosystem,” Bancel said during his opening statement. “When expectations and review timelines are unpredictable, companies face greater risk and can hesitate to invest, slowing the development of breakthrough medicines.”
Bancel then said that this roadblock will mean that companies like Moderna will turn elsewhere for regulatory filings, leaving the U.S. without the next generation of breakthrough medicines.
Going Global
CBER’s decision also imperiled Moderna’s combo flu-COVID vaccine mRNA-1083. The company had been waiting for the flu shot mRNA-1010 to advance in the regulatory process before filing the combo.
While they wait for regulatory clarity from the FDA—a Type A meeting should be made available within 30 days of the rejection—executives say the company will move on with applications for both shots in other parts of the world.
Already mRNA-1083 has been submitted in Europe and Canada, while mRNA-1010 has been submitted in Europe, Canada and Australia. Approvals for the latter could start rolling in by the end of the year. Hoge said that revenue from the products could begin to show up from international markets for the 2027–2028 seasonal flu season.
Moderna’s original COVID-19 vaccine has never had access to the European markets because Pfizer and BioNTech locked down a long-term contract for their joint shot Comirnaty. That contract expires this year, according to Hoge. Moderna plans to move the second-generation COVID vaccine mNEXSPIKE into Europe. That product, along with the flu and combo, will help Moderna tap into a respiratory disease market worth up to $1.8 billion, the R&D chief said.
More Losses
Regulatory trouble notwithstanding, Moderna had a fairly productive quarter, given the company’s challenges over the past few years. The vaccine business beat analyst expectations with $645 million, compared to the $618 million consensus. This was primarily thanks to COVID shots Spikevax and mNEXSPIKE.
Revenue for the full year, which had been pre-announced, was $1.94 billion, or $100 million above the midpoint of the company’s original 2025 guidance, which was $1.6 billion to $2 billion.
Reflecting the beats, Moderna’s shares, which had been battered by the FDA action earlier in the week, rose nearly 4% to $44.03 on Friday morning, erasing the previous losses.
But Moderna is still losing significant amounts of money and has been for five straight quarters. The company lost $826 million for the fourth quarter, which was better than the consensus of a $1.02 billion loss. For the full year, Moderna lost a staggering $2.8 billion.
To help stem the ongoing losses, Moderna has been undergoing an aggressive cost-cutting campaign. Bancel said that AI has “touched every part of our business” to find efficiencies, and new ones are expected to be revealed as that work continues.
