Product Approval
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FY2026 Q1
Improving
Moderna, Inc. earnings call
Buzzberg read
First flu-COVID combo vaccine approved in EU, fourth product approved.
Moderna reported a strong Q1 with higher-than-expected revenue driven by UK partnership deliveries, reiterating its up to 10% growth guidance for 2026. Q1 revenues of $400M up significantly y/y, driven by the UK spring campaign delivery.
Buzzberg read First flu-COVID combo vaccine approved in EU, fourth product approved. Moderna reported a strong Q1 with higher-than-expected revenue driven by UK partnership deliveries, reiterating its up to 10% growth guidance for 2026. Q1 revenues of $400M up significantly y/y, driven by the UK spring campaign delivery. Read full analysisCollapse analysis
Moderna reported a strong Q1 with higher-than-expected revenue driven by UK partnership deliveries, reiterating its up to 10% growth guidance for 2026. Q1 revenues of $400M up significantly y/y, driven by the UK spring campaign delivery.
- EU approval of the first flu+COVID combination vaccine (mCombriax) and MnexPak approvals in the EU are key regulatory wins, positioning for 2027 launches.
- Completed a $950M settlement with Arbutus/Genebon; a potential $1.3B further liability is not reserved.
- Initiated a new Phase III lung cancer study in stage 1 disease, potentially expanding INT to a wider patient population.
Revenue$0.389B-43% QoQ
EPS$-3.40Reported
Free cash flow$-0.692BReported
Capex$0.062BReported
6 grounded callouts
What matters now
The highest-signal changes from the call.
Pipeline
New Phase 3 trial in stage one NSCLC initiated.
Demand
UK spring and fall deliveries expected; international revenue strong.
Show 3 more callouts
Pipeline
Norovirus Phase 3 fully enrolled, data expected in 2026.
Pipeline
PA program pivotal data expected later this year; MMA deferred.
Costs
R&D costs down 24% YoY, adjusted cash costs down 26%.
Reported period
Actuals
| Metric | Reported | Change |
|---|---|---|
| Revenue | $0.389B | -43% QoQ |
| EPS | $-3.40 | Reported |
| Free cash flow | $-0.692B | Reported |
| Capex | $0.062B | Reported |
| Net income | $-1.343B | Reported |
Forward-looking
Forward guidance
| Metric | Period | Range | Midpoint | Status |
|---|---|---|---|---|
| Capex | FY2026 | $0.2B–$0.3B | $0.25B | Maintained |
| Revenue | FY2026 | $0B | $0B | Maintained |
| Revenue | FY2026 | $4.5B–$5B | $4.75B | Guided |
| Revenue | FY2026 Q2 | $0.05B–$0.1B | $0.075B | Guided |
| Revenue | FY2026 Q1 | $0.4B | $0.4B | Guided |
AI, capex & demand read
Management read
Confident
Management expressed confidence in execution, highlighting strong Q1 performance, reiterating guidance, and emphasizing multiple upcoming catalysts across the pipeline.
Management AI read
Management highlighted ongoing investment in AI with cross-enterprise projects to reinvent work and drive personal productivity, positioning AI as a tool to accelerate discovery and expand mRNA into new modalities.
all 4 named companies below
Companiesreturns since call
Partners
Partners
Stephen Hogue
The initiation of the INT Phase III in stage 1 lung cancer as a monotherapy is a significant expansion of the addressable market and a potentially pivotal trial. — Success could open a huge market segment where treatment is surgery and watchful waiting, and also support a monotherapy profile for INT.
Evidence
“We and our partner, Merck, have been really excited by the clinical data that we've seen within TIS4N to date”
Partners
Stéphane Boncel
CEPI's support is funding Moderna's pandemic flu program, now in Phase III, a non-commercial partnership.
Evidence
“we support from CEPI, our pandemic flu program, mRNA-1018, has now initiated its phase three study”
Supply chain
Supply chain
Jamie Mock
A settlement payment shared with Arbutus will be a cash inflow for Geneosoma, but the exact split is not disclosed.
Evidence
“we entered into a settlement agreement with Arbutus and Genobon, resolving all litigation with them worldwide.”
External signals
Supply-chain alpha · 5returns since call
The initial flu+COVID combo vaccine (mCombriax) approval in the EU creates manufacturing complexity for Moderna, but they expect no revenue in 2026, indicating launch is back-end loaded to 2027.
Evidence
“we do not expect revenues in the year of approval for these vaccines. And so, 1083 or M-combriax or flu in the United States, none of those are in our guidance”
A $950M settlement payment to Arbutus/Genebon is due in Q3 2026, but Moderna has not reserved the potential $1.3B Section 1498 liability, creating a binary cash risk event in 2027-2028.
Evidence
“If, however, the Federal Circuit affirms liability under Section 1498, Moderna has agreed to make an additional payment of up to $1.3 billion.”
mRNA-1010 flu vaccine receives PDUFA date of August 5, 2026 in the US; FDA review is progressing 'normal course' with no commentary on new CBER leadership affecting the review.
Evidence
“we are awaiting further guidance from the FDA on the next steps for resuming filing in the United States.”
The initiation of the INT Phase III in stage 1 lung cancer as a monotherapy is a significant expansion of the addressable market and a potentially pivotal trial.
Evidence
“the right approach there was to go into a phase three, potentially pivotal study.”
The MMA program has been deferred until after PA readout, indicating management is prioritizing the more de-risked PA program for capital allocation.
Methodology & coverage
Management-only analysis. All 4 validated company mentions are shown. Reported actuals and forward guidance are kept separate. Public evidence is limited to eight short attributed quotes. AI-generated analysis can be incomplete or wrong; verify important claims against the original source.