Moderna’s norovirus vaccine failed in a Phase 3 trial, but the company still has faith in an ambitious revenue growth target thanks to ex-U.S. vaccine sales and a unanimous FDA adcomm win for mFLUSIVA.
Buoyed by ex-U.S. vaccine contracts, Moderna is maintaining its up to 10% growth target compared to last year’s revenue, cushioning a late-stage setback for an experimental norovirus vaccine.
Moderna’s norovirus candidate mRNA-1403 failed to meet statistical significance in a Phase 3 interim analysis, according to the company’s Friday earnings report. The ongoing NOVA 301 study has enrolled nearly 38,000 participants and will remain blinded as Moderna works to recruit an additional cohort.
Executives were limited in what they could share because of the trial’s blinded status, President Stephen Hoge said on a Friday call with investors. The biotech hasn’t shared the statistical analysis plan for the study yet.
“The epidemiology of the primary endpoint cases has been a little bit slower coming,” Hoge said. “Some of that in the first season for that trial was the result of a unique outbreak of a different set of strains of norovirus.”
Moderna conducted an interim analysis after the second season and is now gearing up to include a third, additional season—winter of this year, Hoge explained.
“We know we will need additional cases from a further cohort to strengthen that statistical analysis,” he said. “This has happened with other vaccines in the past. If you think about flu vaccines, they often have to do multiple season studies to accrue sufficient cases.”
Moderna is also deferring a development decision for its investigational, liver-targeting asset mRNA-3705 for a rare genetic disorder called methylmalonic acidemia. The company will wait for a Phase 1/2 readout—which holds registrational potential—before deciding whether to advance the asset.
In the most recent quarter, the big biotech also terminated an inhaled mRNA candidate for cystic fibrosis (CF) that was being developed with Vertex Pharmaceuticals. The pair, who teamed up in 2020, discontinued a Phase 1/2 study due to tolerability and ended any further development of the asset, dubbed VX-522.
Still, Moderna was buoyed by ex-U.S. vaccine sales, reiterating its 2026 cash guidance targeting up to 10% growth as compared to last year’s revenue of $1.94 billion. The biotech reported a beat on quarterly revenue at $145 million and expects the annual total to be split evenly between the U.S. and international markets.
Quarterly vaccine sales of $94 million topped consensus expectations of $74 million, according to a Friday note from William Blair. Revenue was largely driven by international sales of COVID-19 vaccines Spikevax and mNexspike.
“The second quarter is always a modest revenue quarter for Moderna” because it doesn’t align with typical vaccination timing for the Northern Hemisphere, William Blair analysts wrote.
“I think the biggest variable comes down to the U.S.,” Moderna CFO Jamey Mock said on Friday’s call. “We have provided for a vaccination rate decline, particularly in the U.S. And so, the biggest upside swing is if it is not as big a decline as we’ve projected.”
Earlier this year, Moderna shifted strategy amid growing anti-vaccine rhetoric in the U.S. and at the Department of Health and Human Services. These changes made it challenging for the company to envision a return on investment in vaccine development, Moderna CEO Stéphane Bancel said at the end of January. That prompted the company to scale down investment in vaccine development.
The divestment and wind-down of certain later-stage programs prompted a 7% decline in R&D spend, with Moderna incurring $651 million for research in the second quarter.
Now, Moderna is preparing for the potential approval of its seasonal flu vaccine mFLUSIVA, with an FDA target action date of Aug. 5 and a unanimous positive adcomm decision under its belt.
The flu candidate has been embroiled by controversy—namely from the FDA. In February, the agency initially refused to accept Moderna’s filing for review, citing trial design concerns. Immediate industry-wide backlash followed, with the FDA quickly reversing course and accepting an amended application.
If approved, the vaccine would be Moderna’s fifth product to reach the U.S. market and would be the first mRNA seasonal flu shot marketed in the U.S.
The company has recently tapped Ester Banque as chief commercial officer to oversee the potential rollout, with applications also under review in Europe, Canada and Australia. Banque has prior experience at Zoetis, Bristol Myers Squibb and Novartis, according to her LinkedIn profile.
As of June 30, Moderna had $6.9 billion in cash and investments, sinking from $7.5 billion as of March 31. The biotech recorded a net loss of $782 million, or $1.97 per share, beating the expected consensus loss of $814 million.
“Moderna continues to cut R&D and SG&A expenses faster than consensus, which led to the bottom-line beat,” William Blair wrote.
