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    MRNA
    Earnings call· Sep 2025(Q3 FY25)

    Moderna, Inc. MRNA

    Nov 6, 2025 Source

    Executive summary

    Moderna Q3 FY25 — Strong Cost Reduction and mNEXSPIKE Uptake

    Moderna delivered a mixed third quarter, marked by significant progress in cost reduction and strong uptake of its new COVID vaccine, mNEXSPIKE, which now leads its franchise. Despite a net loss and the discontinuation of its CMV program, the company is ahead of its cash cost reduction targets and has increased its year-end cash balance projection. Management remains committed to achieving cash breakeven by 2028 through continued financial discipline and pipeline advancement.

    Highlights

    5

    • Total revenue reached $1 billion in Q3 FY25, driven by Spikevax, mNEXSPIKE, and mRESVIA sales.

    • Cost reduction efforts led to a 34% year-over-year reduction in combined cost of sales, R&D, and SG&A in Q3 FY25.

    • Full-year 2025 cash cost estimate reduced by $900 million, from $5.5 billion to $4.6 billion.

    • Year-end cash guidance increased to $6.5 billion to $7 billion, up $0.5 billion to $1 billion from prior guidance.

    • mNEXSPIKE achieved 55% of Moderna's COVID vaccination volume and a 42% retail market share, up 2 percentage points year-over-year.

    Concerns

    5

    • Net loss for the quarter was $200 million, compared to net income of $13 million in Q3 FY24.

    • The CMV vaccine program did not meet its primary efficacy endpoint for congenital CMV and will be discontinued in this indication.

    • Norovirus Phase III study has not yet accrued sufficient cases for interim analysis, requiring enrollment for a second Northern Hemisphere season.

    • Total revenue declined 45% year-over-year, primarily due to lower COVID vaccine demand.

    • U.S. COVID vaccination rates are down approximately 30% year-over-year as of October 24, 2025.

    Guidance & targets

    15
    CategoryTargetConfidence
    Full-year 2025 Total Revenue
    $1.6 billion to $2 billion
    high materiality
    High
    Full-year 2025 U.S. Revenue
    $1 billion to $1.3 billion
    medium materiality
    High
    Full-year 2025 International Revenue
    $600 million to $700 million
    medium materiality
    High
    Full-year 2025 GAAP Operating Expense
    $5.3 billion (midpoint)
    high materiality
    High
    Full-year 2025 Cash Cost
    $4.6 billion
    high materiality
    High
    Full-year 2025 Cost of Sales
    $0.8 billion to $0.9 billion
    medium materiality
    High
    Full-year 2025 R&D Expense
    $3.3 billion to $3.4 billion
    medium materiality
    High
    Full-year 2025 SG&A Expense
    $1.1 billion
    low materiality
    High
    Full-year 2025 Capital Expenditures
    approximately $300 million
    low materiality
    High
    Year-end 2025 Cash and Investments Balance
    $6.5 billion to $7 billion
    high materiality
    High
    Cash Breakeven
    2028
    high materiality
    High
    mRNA-1010 Regulatory Submissions
    Complete regulatory submissions for approval
    medium materiality
    High
    mRNA-1083 Health Canada Refiling
    Refile with Health Canada
    medium materiality
    High
    mRNA-1083 U.S. Refiling
    Refile with FDA
    medium materiality
    Medium
    MMA Registrational Trial Start
    Start in 2026
    low materiality
    High

    Segment performance

    2
    SegmentRevenueYoYQoQMargin
    U.S. Market
    The vast majority of U.S. revenue was from COVID vaccines, including the successful launch of mNEXSPIKE. The market share for COVID vaccines increased, driven by mNEXSPIKE's strong uptake.
    COVID retail market share: 42%COVID retail market share change: +2 percentage points YoYmNEXSPIKE share of COVID vaccination volume: 55%Cumulative retail vaccinations (as of Oct 24): $13.2MCumulative retail vaccinations change: -30% YoY
    		$800M———
    International Markets
    Approximately half of international revenue in Q3 was delivered to Canada, executing on a strategic partnership. Other strategic partnerships in Australia and the U.K. are expected to contribute revenue in Q4 FY25 and Q1 FY26, respectively.
    		$200M———

    Operational metrics

    21
    Total Revenue
    $1B-45% YoY
    Q3 FY25

    Driven by sales of Spikevax, mNEXSPIKE, and mRESVIA. The year-over-year decline was expected due to lower COVID vaccine demand and a prior-period true-up adjustment that did not repeat.

    Net Product Sales
    $973M
    Q3 FY25

    Component of total revenue.

    Other Revenue (Grants, Collaborations, Royalties, Stand-ready fees)
    $43M
    Q3 FY25

    Component of total revenue.

    Cost of Sales
    $207M-60% YoY
    Q3 FY25

    Improvement driven by lower inventory write-downs, reduced unutilized manufacturing capacity, and lower volume, reflecting productivity gains and efficiency improvements.

    R&D Expenses
    $801M-30% YoY
    Q3 FY25

    Reduction mainly reflects lower clinical trial costs as several large Phase III studies were completed, as well as efficiency gains. Last year's results included a priority review voucher expense.

    SG&A Expenses
    $268M-5% YoY
    Q3 FY25

    Decline mainly reflects lower consulting and external service costs, along with reduced digital and facility spending, reflecting cost discipline.

    Net Loss
    $200Mvs Net Income of $13M in Q3 FY24
    Q3 FY25

    Compared to net income in the prior year.

    Loss Per Share
    $0.51vs EPS of $0.03 in Q3 FY24
    Q3 FY25

    Compared to earnings per share in the prior year.

    Cash and Investments Balance
    $6.6Bdown from $7.5B at Q2 FY25 end
    Q3 FY25 end

    Decrease primarily driven by seasonal impact to working capital.

    Cost Reduction (Q4 FY24 to Q3 FY25)
    $2.1Bvs prior 4 quarters
    Trailing 4 quarters

    Reflects continuous cost improvement program.

    Projected 2025 Cash Cost Reduction
    $500Msince last quarter investor call
    FY25

    Part of ongoing cost improvement program.

    Projected 2025 Cash Cost Reduction (YTD)
    $900Msince beginning of year
    FY25

    Part of ongoing cost improvement program.

    GAAP Operating Expenses (Original Target)
    $6.4Bvs $7.2B in 2024
    FY25

    Original target for 2025.

    Cash Costs (Original Target)
    $5.5Bvs $6.3B in 2024
    FY25

    Original target for 2025.

    GAAP Operating Expense Reduction (from prior guidance)
    $700Mfrom $6B to $5.3B
    FY25

    Due to additional progress across the company to drive efficiency gains and continued investment prioritization.

    Cash Cost Reduction (from prior guidance)
    $500Mfrom $5.1B to $4.6B
    FY25

    Part of the $700M GAAP reduction.

    Cost of Sales Forecast Reduction
    $300M to $400Mfrom $1.2B to $0.8B-$0.9B
    FY25

    Reflects an acceleration of efficiency programs as part of a multiyear cost-out plan.

    R&D Expense Improvement
    $350M
    FY25

    Due to continued investment prioritization and efficiency gains in clinical trial execution.

    Cash Cost Reduction (2023 to 2025)
    50%from nearly $9B in 2023 to $4.6B in 2025
    2023-2025

    Significant reduction over two years.

    Income Tax Provision
    immaterialconsistent with prior year
    Q3 FY25

    Due to global valuation allowance against deferred tax assets.

    Tariff Impact
    not expected to have a material impact
    FY25

    Company continues to monitor changes to global tariffs.

    Industry KPIs

    4
    MetricValueDetails
    Pipeline read out calendarMultiple readouts and filings expected
    Regulatory approvals filingsMultiple approvals and filings
    Therapeutic drug market share42%%
    Clinical trial efficacy safety dataPositive and negative results

    Product announcements

    3
    ProductTypeDetails
    Spikevax (2025-2026 Formula)update
    mNEXSPIKE (new COVID vaccine)launch
    mRESVIA (RSV vaccine)expansion

    Deals & partnerships

    5
    CanadaStrategic partnership with in-country manufacturing facility and multiyear offtake agreement.multiyear

    Established manufacturing facilities and secured a multiyear offtake agreement. First made-in-Canada mRNA vaccines delivered to the Canadian government.

    U.K.Strategic partnership with in-country manufacturing facility and multiyear offtake agreement.multiyear

    Established manufacturing facilities and secured a multiyear offtake agreement. Facilities granted licenses by regulatory agencies.

    AustraliaStrategic partnership with in-country manufacturing facility and multiyear offtake agreement.multiyear

    Established manufacturing facilities and secured a multiyear offtake agreement. Facilities granted licenses by regulatory agencies.

    MerckCollaboration for intismeran program.

    Multiple late-stage studies for intismeran are conducted in partnership with Merck, including Phase III in adjuvant melanoma and Phase II in adjuvant renal cell carcinoma.

    BlackstonePartnership on flu program (mRNA-1010).

    Mentioned in Q&A as an example of a financial sponsor partnership for pipeline assets.

    Risks & headwinds

    4
    Lower COVID vaccine demandQ3 FY25 and ongoing

    Total revenue declined 45% YoY; U.S. cumulative retail vaccinations down 30% YoY as of October 24, 2025.

    Mitigation: Successful launch and uptake of mNEXSPIKE, increased market share, strategic partnerships for international sales.

    CMV vaccine program failureQ3 FY25

    mRNA-1647 did not meet primary efficacy endpoint for congenital CMV.

    Mitigation: Discontinuation of congenital CMV indication; continued evaluation in bone marrow transplantation Phase II trial.

    Norovirus Phase III study delayExtends into second Northern Hemisphere season (this winter)

    Insufficient cases accrued for interim analysis after first season.

    Mitigation: Proceeding to enroll a second Northern Hemisphere season; study designed for potential two-season enrollment.

    Arbutus IP litigationOngoing, with trial in March 2026

    U.S. trial scheduled for March 9, 2026.

    Mitigation: Vigorously defending the case, confident technology does not infringe valid patents.

    What to watch in Q4 FY25

    5

    mRNA-1010 Regulatory Submissions

    by January 2026
    CurrentPositive Phase III data announced
    TargetCompletion of regulatory submissions in US, Canada, Australia, Europe

    Why it matters

    Successful submissions are critical for the commercialization of the seasonal flu vaccine, a key pipeline asset.

    For our flu vaccine candidate, MRNA-1010, we expect to complete regulatory submissions for approval in the United States, Canada, Australia and Europe by January 2026.

    Q&A highlights

    8

    What is being deprioritized for cost reductions, and what is the strategy regarding the Arbutus IP dynamics?

    Cost reductions are driven by accelerating manufacturing efficiencies and more efficient clinical trial execution, with some prioritization decisions in R&D. The company is confident in its technology and is vigorously defending against Arbutus's patent infringement claims, with a U.S. trial scheduled for March 2026.

    “We believe that our technology does not infringe any valid patents asserted by Arbutus.”

    asked by Salveen Richter · answered by James Mock

    2 min read6 chapters

    Detailed Narrative

    01

    Commercial Product Performance and Market Share

    Moderna's Q3 FY25 revenue was $1 billion, primarily from Spikevax, mNEXSPIKE, and mRESVIA. U.S. revenue was $800 million, largely from COVID vaccines, including the successful launch of mNEXSPIKE. International revenue was $200 million, with half from Canada due to strategic partnerships. The company's COVID retail market share increased to 42%, up 2 percentage points year-over-year, with mNEXSPIKE comprising 55% of its COVID vaccination volume, exceeding expectations due to its clinical profile and market momentum towards higher-risk populations.

    02

    Strategic Partnerships and Global Expansion

    Moderna is leveraging strategic partnerships in Canada, the U.K., and Australia. In Canada, the first made-in-Canada mRNA vaccines were delivered. Facilities in the U.K. and Australia received regulatory licenses, with local product shipments expected in Q4 FY25 and Q1 FY26, respectively. These partnerships are anticipated to contribute to revenue growth in FY26, as the U.K. deliveries shifted outside of FY25.

    03

    Pipeline Advancement in Respiratory Vaccines

    The company announced positive Phase III flu efficacy data for mRNA-1010, which is expected to advance both the flu vaccine program and the flu plus COVID combination program (mRNA-1083). Regulatory submissions for mRNA-1010 are planned for the U.S., Canada, Australia, and Europe by January 2026. The mRNA-1083 filing is under review by the European Medicines Agency, and refiling with Health Canada is expected by year-end 2025, with U.S. refiling awaiting FDA guidance.

    04

    Oncology and Rare Disease Portfolio Progress

    In oncology, encouraging Phase Ib data for cancer antigen therapy mRNA-4359 was presented at ESMO, leading to Phase II studies in metastatic melanoma and non-small cell lung cancer. The intismeran program (partnered with Merck) has several late-stage studies underway, including fully enrolled Phase III trials in adjuvant melanoma and Phase II in adjuvant renal cell carcinoma. In rare diseases, the propionic acidemia (PA) program reached target enrollment for its registrational study, and the methylmalonic acidemia (MMA) registrational trial is expected to start in 2026.

    05

    CMV Program Discontinuation and Learnings

    Moderna announced the discontinuation of its CMV vaccine program (mRNA-1647) for congenital CMV after it failed to meet the primary efficacy endpoint in Phase III. Management noted that pentamer neutralizing antibodies, previously hoped to be the missing piece for preventing infection, were not sufficient. The company will continue to evaluate mRNA-1647 in an ongoing Phase II trial for patients undergoing bone marrow transplantation, focusing on disease prevention rather than infection prevention.

    06

    Aggressive Cost Reduction and Financial Discipline

    Moderna has significantly reduced its projected 2025 cash costs by $900 million since the beginning of the year, now targeting $4.6 billion. This includes a $500 million reduction since the last quarter. GAAP operating expenses are now guided to $5.3 billion, a $700 million reduction from prior guidance. These savings are attributed to accelerated efficiency programs in manufacturing, reduced unutilized capacity, and prioritization of R&D investments, with a continued focus on streamlining operations.

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