Moderna (MRNA) Q4 FY25 earnings call: guidance and Q&A

What are the implications of the flu RTF for 2028 cash flow breakeven guidance, and when will visibility on next steps be available? Can the timing for INT adjuvant melanoma data be refined?

Management stated that the flu RTF situation is fresh and fluid, making it difficult to comment on 2028 breakeven guidance without understanding the resolution. They highlighted multiple growth drivers and cost momentum. For INT melanoma, it's an event-driven trial, and while confident it will read out this year, specific timing cannot be provided.

“without understanding the resolution of what is next for our flu product, it's a little bit difficult to comment at this time.”

asked by Terence Flynn · answered by James Mock

How does the 1010 RTF impact the flu/COVID combination vaccine refiling in the U.S.? What data was in the 1010 submission? Which INT histologies have the highest probability of success?

The flu/COVID combo vaccine refiling in the U.S. is gated by the 1010 Type A meeting. The 1010 submission included a 41,000-person Phase III study showing 27% superior relative vaccine efficacy and an immunogenicity study showing superiority to Fluzone High-Dose. Adjuvant melanoma is considered to have the highest probability of success for INT, given the strong 5-year Phase II data.

“at 27%, we felt very good that we were in line in demonstrating superiority in exactly the same way that those standard of cares have in the same population, those over the age of 65.”

asked by Elizabeth Webster · answered by Stephen Hoge

How is Moderna thinking about the European COVID vaccination market, pricing, and vaccination rates? What is the pathway for flu/COVID combo approval outside the U.S.? Are there discussions on flu strain selection closer to the season in Europe/Canada?

Moderna expects mNEXSPIKE to be competitive in Europe, where the market is estimated to be larger than the current $700 million in shots-in-arms. The flu/COVID combo product is progressing internationally, with potential European launch this year or in 2027. There is strong international support for better flu strain matching, with some regulators advocating for later strain selection and more diverse options.

“what we're hearing from the international flu community, including, as I said, in Europe, is quite strong support for that. It's a real question today.”

asked by Eliana Merle · answered by Stephen Hoge

Why was the year-end cash balance higher than expected, and what are future levers to lower cash costs?

The higher cash balance was due to a $1.2 billion beat on cash costs, a $600 million initial credit facility draw, $100 million less in capital expenditures, and $200 million from working capital improvements, including receivables at $180 million, inventory at $270 million, and payables at $300 million.

“cash costs came in at $4.3 billion. So we beat by $1.2 billion. On top of that, we took $600 million of the initial draw from the loan, so that's now $1.8 billion better.”

asked by Gregory Wiessner · answered by James Mock

Does the INT Phase III melanoma study have interims? What is the confidence level for the norovirus Phase III readout this year, considering its trivalent strain approach?

The INT melanoma Phase III study will have an interim analysis for relapse-free survival this year, with subsequent analyses if needed. For norovirus, the Phase III is a case-driven trial, and management is excited for potential results this year. They highlighted the trivalent composition, VLP technology, and targeting seropositive older adults as key differentiators from previous efforts.

“we're looking in seropositive populations, not children... it's much more like -- it's a bit like primary vaccination for whatever it is, RSV or flu or COVID, being very, very different than boosting seropositive people.”

asked by Michael Yee · answered by Stephen Hoge

What percentage of patients in the flu 1010 efficacy study were 65 or older? What feedback has been received on INT trial design, who is the sponsor, and which FDA group will assess it?

Over 50% of the flu 1010 efficacy study population was 65 or older, with over 10% above 75, showing consistent superior efficacy across age groups. For INT, there has been robust and productive engagement with regulators, with broad alignment. CBER is the FDA group involved, and Merck is the sponsor for the Phase III study and BLA submission.

“More than 50% of the population in the study, but it was stratified that at least 50% would be over the age of 65.”

asked by Courtney Breen · answered by Stephen Hoge