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    MRNA
    Earnings call· Dec 2025(Q4 FY25)

    Moderna Q4 FY25 earnings call MRNA

    Feb 13, 2026 Source

    Executive summary

    Moderna Q4 FY25 — Strong mNEXSPIKE Launch and Cost Reduction

    Moderna delivered Q4 FY25 results at the high end of revenue guidance, driven by strong mNEXSPIKE uptake and significant cost reductions across the organization. Despite a U.S. FDA Refusal-to-File for its flu vaccine, the company is advancing its late-stage pipeline, including oncology and rare disease programs, and expects a return to revenue growth in 2026, primarily from international markets and mNEXSPIKE.

    Highlights

    5

    • Full-year 2025 operating expenses decreased by $2.2 billion or 30%.

    • Q4 2025 total revenue reached $700 million, at the higher end of guidance.

    • mNEXSPIKE achieved a 24% market share in the total U.S. retail market and 34% among adults aged 65+ in its first season.

    • Ended 2025 with $8.1 billion in cash and investments, exceeding guidance by over $2 billion.

    • Secured new strategic agreements with Mexico and Taiwan, and a global commercialization deal for propionic acidemia with Recordati.

    Concerns

    2

    • Received an FDA Refusal-to-File letter for the flu program, mRNA-1010, creating regulatory uncertainty in the U.S.

    • Net loss for Q4 2025 was $800 million, and $2.8 billion for the full year.

    Guidance & targets

    12
    CategoryTargetConfidence
    Total revenue growth
    up to 10%
    high materiality
    High
    Cost of sales
    approximately $900 million
    medium materiality
    High
    R&D expenses
    approximately $3 billion
    medium materiality
    High
    SG&A expenses
    approximately $1 billion
    medium materiality
    High
    Taxes
    negligible
    low materiality
    High
    Capital expenditures
    between $200 million and $300 million
    medium materiality
    High
    Cash and investments balance
    $5.5 billion to $6 billion
    high materiality
    High
    Revenue weighting (H1 vs H2)
    15% in first half, 85% in second half
    low materiality
    High
    mNEXSPIKE, mRNA-1010, flu/COVID combo launch in Europe
    Launch by 2027 winter season
    high materiality
    High
    Flu vaccine international revenue contribution
    Begin to contribute to revenue internationally
    medium materiality
    Medium
    Combination flu/COVID and norovirus vaccines launches
    Potentially launched across many markets
    medium materiality
    Medium
    U.K. COVID order fulfillment
    $200 million
    medium materiality
    High

    Segment performance

    7
    SegmentRevenueYoYQoQMargin
    Total Company
    Total revenue for the fourth quarter of 2025, at the higher end of recent guidance.
    		$700 million———
    U.S.
    U.S. revenue for the fourth quarter of 2025.
    		$300 million———
    International
    International revenue for the fourth quarter of 2025.
    		$400 million———
    Total Company
    Total revenue for the full year 2025, primarily from COVID vaccine sales.
    		$1.9 billion———
    U.S.
    U.S. revenue for the full year 2025.
    		$1.2 billion———
    International
    International revenue for the full year 2025.
    		$700 million———
    Geographic Mix
    Expected shift in geographic revenue mix for 2026, with a more balanced contribution from U.S. and international markets compared to 2025.
    2025 U.S. revenue: 62%2025 International revenue: 38%2026 Geographic Mix: Well balanced between U.S. and international
    		————

    Operational metrics

    33
    Q4 2025 Total Revenue
    $700 million
    Q4 FY25

    At the higher end of recent guidance.

    Q4 2025 Net Loss
    $800 millionvs $1.1 billion net loss in Q4 2024
    Q4 FY25

    Compared to a net loss of $1.1 billion in the fourth quarter of 2024.

    Q4 2024 Net Loss
    $1.1 billion
    Q4 FY24

    Net loss in the fourth quarter of 2024.

    Q4 2025 Loss per Share
    $2.11vs $2.91 loss per share in Q4 2024
    Q4 FY25

    Compared to a loss per share of $2.91 last year.

    Q4 2024 Loss per Share
    $2.91
    Q4 FY24

    Loss per share in the fourth quarter of 2024.

    Original 2025 Revenue Guidance (upper end)
    $2.5 billion
    FY25

    Part of the original guidance range of $1.5 billion to $2.5 billion for 2025 revenue.

    Original 2025 Cash Usage Forecast
    $3.5 billion
    FY25

    Calculated from $5.5 billion cash costs and $2 billion midpoint revenue from original guidance, against a starting cash balance of $9.5 billion.

    Full Year 2025 Total Revenue
    $1.944 billion
    FY25

    Came in close to original guidance midpoint.

    Full Year 2025 Cash Costs
    $4.3 billionbeat by $1.2 billion vs original forecast
    FY25

    Beat original forecast by $1.2 billion.

    Full Year 2025 Operating Expenses
    $2.2 billiondown 30% YoY
    FY25

    Reflecting continued cost discipline across the organization.

    Full Year 2025 Cost of Sales
    $868 million41% decrease compared to 2024
    FY25

    Primarily driven by productivity, lower inventory write-downs, contract manufacturing wind-down costs, and sales volumes.

    Full Year 2025 R&D Expenses
    $3.1 billion31% decrease compared to 2024
    FY25

    Driven by continued investment prioritization and efficiency gains, partially offset by increased investment in norovirus and oncology programs.

    Full Year 2025 SG&A Expenses
    $1 billion13% decrease compared to 2024
    FY25

    Decline driven across all functions, reflecting focus on operating efficiently.

    Full Year 2025 Net Loss
    $2.8 billionvs $3.6 billion in 2024
    FY25

    Compared to a net loss of $3.6 billion in 2024.

    Full Year 2025 Loss per Share
    $7.26vs $9.28 in 2024
    FY25

    Compared to a loss per share of $9.28 in 2024.

    Cash and Investments Balance
    $8.1 billionvs $9.5 billion at end of 2024
    End of FY25

    Decrease primarily driven by operating losses, partially offset by credit facility draw. Exceeded 3Q guidance of $6.5 billion to $7 billion.

    Cash and Investments Balance
    $9.5 billion
    End of FY24

    Cash and investments balance at the end of 2024.

    Credit Facility Draw
    $600 million
    FY25

    Initial draw from the $1.5 billion credit facility.

    Cash and Investments Guidance
    $6.5 billion to $7 billion
    End of FY25

    Guidance provided at the end of Q3 2025.

    mNEXSPIKE U.S. Retail Market Share
    24%
    2025 season

    Achieved in its first season, with the retail market representing approximately 75% of the U.S. COVID market.

    mNEXSPIKE U.S. Retail Market Share (Adults 65+)
    34%
    2025 season

    Achieved in its first season, with the majority of volume in seniors.

    European Respiratory Vaccines Market
    $1.8 billion
    Future

    Expected to open in 2027, following the expiration of a competitor pandemic contract in 2026.

    European COVID Market (shots in arms)
    $700 million
    Current

    Estimate of current market size based on shots in arms, not accounting for wastage.

    Receivables
    $180 million
    End of FY25

    Part of working capital improvements.

    Inventory
    $270 millionflat year-over-year
    End of FY25

    Part of working capital improvements.

    Payables
    $300 million
    End of FY25

    Part of working capital improvements.

    Net Working Capital Balance
    $150 million
    End of FY25

    Reflects strong performance from the team.

    mRNA-1010 Phase III Relative Vaccine Efficacy
    27%superior vs standard dose control
    Trial results

    Demonstrated in a Phase III study, with results comparable to or better than other licensed flu vaccines.

    Fluzone Relative Vaccine Efficacy
    24%
    Historical

    As seen in USPI for Fluzone, for those over 65.

    Flublok Relative Vaccine Efficacy
    30%
    Historical

    As seen in USPI for Flublok, for those over 65.

    mRNA-1010 Phase III Immunogenicity
    Superiorvs Fluzone High-Dose
    Trial results

    Demonstrated in a Phase III study (P303 study Part C) against Fluzone High-Dose.

    mRNA-1010 Phase III Trial Population (65+)
    >50%
    Trial results

    More than 50% of the 41,000-person study population was over the age of 65, with over 10% above 75.

    Intismeran Adjuvant Melanoma Phase II Relapse/Death Reduction
    ~50%
    5-year data

    Approximately a 50% reduction in the rates of relapse or death from melanoma, with stability in curves through 5 years.

    Industry KPIs

    6
    MetricValueDetails
    Capital deployment$8.1 billionUSD
    Pipeline read out calendarMultiple
    Product franchise net sales$1.9 billionUSD
    Regulatory approvals filingsMultiple
    Therapeutic drug market share24%%
    Clinical trial efficacy safety data27% superior relative vaccine efficacy%

    Deals & partnerships

    6
    RecordatiGlobal Commercialization Agreement

    Agreement for the global commercialization of Moderna's propionic acidemia rare disease candidate, currently in a pivotal study. Recordati brings deep rare disease commercial expertise and an established global infrastructure.

    Government of MexicoStrategic Agreement5-year

    A 5-year strategic agreement for respiratory vaccine supply.

    TaiwanStrategic Agreement

    A multiyear strategic agreement announced last month.

    BrazilStrategic Agreement

    Previously announced strategic agreement, with continued progress being made.

    MerckCollaboration

    Collaboration for intismeran, an individualized cancer therapy. Merck is the sponsor for the Phase III study and BLA submission.

    ImmaticsCollaboration

    Collaboration on the cell therapy enhancing program, mRNA-4203.

    Risks & headwinds

    3
    FDA Refusal-to-File for mRNA-1010 (flu vaccine)Current

    mRNA-1010 received a Refusal-to-File letter from the FDA for the U.S. market.

    Mitigation: Requested a Type A meeting with the FDA to understand the path forward for the program in the United States.

    Regulatory uncertainty in the U.S.Ongoing

    Unpredictable expectations and review timelines for new medicines.

    Mitigation: Engaging with the FDA to clarify requirements and ensure patient access to innovations.

    Potential for flu strain mismatch2026 flu season

    A potential for a mismatch in one of the strains this year (e.g., influenza B in U.S. vs. rest of Northern Hemisphere).

    Mitigation: Highlighting the need for technologies like mRNA to advance new and potentially improved products with better strain matching.

    Q&A highlights

    6

    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

    2 min read6 chapters

    Detailed Narrative

    01

    Regulatory Headwinds for Flu Program

    The FDA issued a Refusal-to-File letter for Moderna's seasonal flu vaccine, mRNA-1010, in the U.S., citing regulatory uncertainty🌐. This decision creates challenges for the company's U.S. market entry for flu, though the vaccine is under review in Europe, Canada, and Australia. Moderna has requested a Type A meeting with the FDA to clarify the path forward, with the process typically taking 30 days.

    02

    Strategic International Expansion

    Moderna is expanding its global footprint through strategic agreements, including a 5-year respiratory vaccine supply deal with Mexico and a recent agreement with Taiwan. These partnerships, along with local manufacturing in the U.K. and Australia starting in 2026, are expected to drive significant international revenue growth. The company also anticipates the European respiratory vaccines market, valued at $1.8 billion, to open up in 2027.

    03

    Oncology Pipeline Progress

    The company reported positive 5-year Phase II data for intismeran (individualized cancer therapy) in adjuvant melanoma, demonstrating durability with approximately a 50% reduction in relapse or death. Enrollment is complete for Phase II studies in muscle invasive bladder cancer, adjuvant renal cell carcinoma, and adjuvant melanoma, with data readouts anticipated in 2026. The cancer antigen therapy mRNA-4359 is now in Phase II, and Dr. David Berman will join as Chief Development Officer to further expand the oncology pipeline.

    04

    Infectious Disease Pipeline

    Beyond COVID, Moderna's infectious disease pipeline is advancing. The norovirus program is fully enrolled in Phase III, with data expected in 2026. The propionic acidemia (PA) program is also fully enrolled in its registrational study, with data expected in 2026. The flu/COVID combination vaccine (mRNA-1083) is under review in Europe and Canada, with potential approvals in 2026.

    05

    Cost Discipline and Efficiency

    Moderna achieved a 30% reduction in operating expenses in 2025, totaling $2.2 billion, and expects cash costs to decline further to $4.2 billion in 2026. The company attributes these efficiencies, in part, to the adoption of AI tools across its business operations. This cost discipline contributed to ending 2025 with $8.1 billion in cash and investments, exceeding prior guidance.

    06

    mNEXSPIKE Commercial Success

    The new COVID vaccine, mNEXSPIKE, had a successful U.S. launch in 2025, capturing 24% of the total U.S. retail market and 34% among adults aged 65 and older. The retail market represents approximately 75% of the U.S. COVID market. The company expects continued uptake in the U.S. and international approvals and launches in multiple countries in 2026 and beyond, including Europe, Japan, and Taiwan.

    AI-generated summary of the company’s earnings call. Not investment advice.