Moderna (MRNA) Q1 FY26 earnings call: guidance and Q&A

Discuss the strategy for Stage 1 NSCLC, its fit in the treatment landscape, and the rationale for a monotherapy arm.

Stephen Hoge explained that the strategy leverages Intismeran's efficacy and strong safety profile to intervene early in high-risk Stage 1 NSCLC, where standard of care is often surgery and watchful waiting. The monotherapy arm aims to provide IO-like protection against relapse with a vaccine-like safety profile. The combination with KEYTRUDA is also being explored for incremental benefit.

“Our goal, simply put, is to intervene early, prevent the relapse or recurrence from ever happening and in so doing, try and achieve cures in the earliest stages of disease.”

asked by Salveen Richter · answered by Stephen Hoge

Request more specific timing for the interim analysis in 2026 and clarify potential outcomes (early success vs. futility).

Stephen Hoge reiterated confidence in the interim analysis being conducted in 2026 based on event accrual but did not refine the timing. He clarified that the interim analysis is designed for early success or continuation, with no built-in futility assessment.

“The interim analysis is either to declare early success or to continue to accrue events in the trial towards a subsequent interim analysis or final analysis both of which could happen in the years ahead.”

asked by Terence Flynn · answered by Stephen Hoge

Inquire about the confidence in prevailing on the $1.3 billion 1498 liability and the timeline for a final ruling. Also, ask about the latest thinking on flu vaccine (mRNA-1010) ahead of PDUFA and any impact from the new acting FDA director.

Jamie Mock stated confidence in prevailing on the 1498 liability, deeming a loss improbable, with a potential resolution in late 2027 or 2028. Stephen Hoge noted normal progress for the mRNA-1010 FDA review towards the August 5 PDUFA date, with no expected impact from senior leadership changes.

“our legal team and ourselves, we are confident, and therefore, we believe it improbable that we would lose and therefore, have not recorded anything.”

asked by Luca Issi · answered by James Mock

Ask about the powering for the interim analysis and what constitutes clinical success in terms of RFS (absolute or relative benefit).

Stephen Hoge did not disclose specific powering assumptions but indicated strong powering if a similar hazard ratio to Phase II is observed. He noted that success could range from the Phase II hazard ratio (1.5%) to 0.8, with a range of clinical benefits being meaningful for patients.

“we think the opportunity for benefit could be anywhere between that 1.5% that we saw in a number like 0.8, where there's a significant benefit still in terms of survival and treatment of melanoma”

asked by Tyler Van Buren · answered by Stephen Hoge

Inquire about expected timing for data from these Phase II studies, what good data would look like, and next steps if positive.

Stephen Hoge stated that both randomized Phase II studies are fully enrolled and event-driven. He highlighted RCC as a key area of interest due to potential for meaningful clinical benefit. He could not guide on specific timing (potentially this year or early next) but emphasized the goal of registrational potential or quick progression to Phase III.

“We don't exactly know when potentially this year or even early next year that those results could come in because they are event-driven analysis.”

asked by Ellie Merle · answered by Stephen Hoge

Clarify revenue recognition parameters for Intismeran with Merck and discuss the Stage 1 lung cancer market, prevalence, and the bar for success.

Jamie Mock explained the revenue recognition model: Moderna delivers product to Merck (COGS + markup), then takes 50% profit split, naturally leading to >50% of profit share. Stephen Hoge noted that Stage 1 lung cancer diagnoses are increasing due to screening, representing a unique opportunity for early intervention. The bar for success is preventing relapse/recurrence with a good benefit-risk profile.

“it will end up being that we deliver the product to Merck because they're obviously the market authorization holder, and they were sell it on to the customer. So that will be the first part of our transaction. And so you can imagine some amount of our COGS plus some markup. Thereafter, whatever the profit split is, then we will take that share -- Our share of that of 50%.”

asked by Courtney Breen · answered by James Mock

Ask about the product split for Q2 revenue and whether there was any pull-through of expected revenues from Q2 into Q1.

Jamie Mock confirmed Q1 revenue was primarily COVID-related, with RSV not expected to be a significant growth driver in 2026. He provided Q2 revenue guidance of $50 million to $100 million, bringing H1 to $440 million-$490 million, and contextualized the full-year phasing by comparing it to prior year's US vs. international split.

“This was largely, the majority is COVID still. So we have not been -- as we've always said, we don't anticipate RSV being a significant growth driver in the year 2026.”

asked by Simon Baker · answered by James Mock