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    MRNA
    Earnings call· Mar 2025(Q1 FY25)

    Moderna Q1 FY25 earnings call MRNA

    May 1, 2025 Source

    Executive summary

    Moderna Q1 FY25 — Cost Reductions and Oncology Pipeline Expansion

    Moderna reported Q1 FY25 results marked by significant cost reductions across R&D, SG&A, and cost of sales, driving an improved net loss despite lower seasonal revenues. The company expanded its oncology pipeline with a new checkpoint program and progressed its late-stage vaccine candidates, though regulatory timelines for some combination vaccines have shifted. Management remains committed to achieving cash breakeven by 2028 through continued financial discipline and strategic pipeline investments.

    Highlights

    5

    • Combined R&D, SG&A, and Cost of Sales reduced by 19% year-over-year in Q1 FY25.

    • Net loss improved by $204 million to $1 billion in Q1 FY25.

    • mRESVIA received approvals in Australia, Taiwan, the U.K., and Switzerland.

    • Oncology portfolio expanded with Checkpoint medicine (mRNA-4359) advancing to Phase II.

    • Phase III flu program exceeded case accruals for interim vaccine efficacy analysis.

    Concerns

    4

    • Q1 FY25 total revenue decreased 35% year-over-year to $108 million.

    • Cost of sales represented 104% of net product sales in Q1 FY25, up from 58% in Q1 FY24.

    • Flu-COVID combination vaccine (mRNA-1083) PDUFA extended to 2026 due to need for Phase III flu efficacy data.

    • Norovirus approval timing uncertain (2026 or 2027) due to case accrual.

    Guidance & targets

    19
    CategoryTargetConfidence
    Full-year 2025 total revenue
    $1.5 billion to $2.5 billion
    high materiality
    High
    Full-year 2025 first half sales
    approximately $0.2 billion
    medium materiality
    High
    Full-year 2025 Cost of sales
    approximately $1.2 billion
    medium materiality
    High
    Full-year 2025 R&D expenses
    approximately $4.1 billion
    medium materiality
    High
    Full-year 2025 SG&A expenses
    approximately $1.1 billion
    medium materiality
    High
    Full-year 2025 taxes
    negligible
    low materiality
    High
    Full-year 2025 capital expenditures
    approximately $400 million
    medium materiality
    High
    End of 2025 cash and investments
    approximately $6 billion
    high materiality
    High
    Additional cost reductions
    $1.4 billion to $1.7 billion
    high materiality
    High
    2026 GAAP operating expense forecast
    $5.4 billion to $5.7 billion
    high materiality
    High
    2026 cash cost (excluding non-cash)
    approximately $4.7 billion
    high materiality
    High
    2027 GAAP expenses
    between $4.7 billion and $5 billion
    high materiality
    High
    2027 cash cost (excluding non-cash)
    approximately $4.2 billion
    high materiality
    High
    Cash breakeven target
    2028
    high materiality
    High
    Flu + COVID combination vaccine approval (mRNA-1083)
    2026
    high materiality
    Medium
    Norovirus vaccine approval
    2026 or 2027
    medium materiality
    Low
    Propionic acidemia (PA) program approval
    2027
    medium materiality
    Medium
    Methylmalonic acidemia (MMA) program approval
    2028
    medium materiality
    Medium
    Targeting filings for Checkpoint and other programs
    by 2028
    high materiality
    Medium

    Operational metrics

    20
    Net product sales
    $86 million
    Q1 FY25

    Driven primarily by COVID vaccine sales.

    Total revenue
    $108 milliondecreased 35% year-over-year
    Q1 FY25

    In line with expectations, reflecting seasonal nature of respiratory vaccines.

    Cost of sales
    $90 milliondecreased $6 million year-over-year
    Q1 FY25

    Primarily due to lower sales volume.

    Cost of sales as % of net product sales
    104%up from 58% in Q1 FY24
    Q1 FY25

    Driven by lower volume and revenue mix.

    R&D expenses
    $856 million19% decrease year-over-year
    Q1 FY25

    Mainly driven by lower clinical development spend across respiratory programs, partially offset by investment in norovirus and oncology.

    SG&A expenses
    $212 million23% decrease year-over-year
    Q1 FY25

    Driven by broad-based cost reductions and focus on streamlining operations.

    Income tax provision
    $7 million
    Q1 FY25

    Not material due to continued valuation allowance on global deferred tax assets.

    Net loss
    $1 billionimproved by $204 million compared to Q1 FY24
    Q1 FY25

    Compared to a $1.2 billion loss in Q1 FY24.

    Cash, cash equivalents and investments
    $8.4 billiondown from $9.5 billion at Q4 FY24 end
    Q1 FY25 end

    Decrease primarily driven by operating loss for the quarter.

    COVID vaccine sales
    $29 million
    Q1 FY25

    U.S. sales only a fraction of total COVID revenue.

    COVID vaccine market share
    38%
    Q1 FY25

    Based on script data, similar to prior year.

    COVID vaccine market share (prior year normalized)
    40%
    FY24

    Normalized U.S. revenue of $1.5 billion in prior year represented 40% market share.

    Americans with risk factor for severe COVID-19
    74%
    current

    Includes those under 64 years old.

    COVID vaccine effectiveness (updated vaccine)
    96%
    this past year

    Also 85% effective at preventing hospitalization.

    COVID vaccine effectiveness (updated vaccine)
    85%
    this past year

    Also 96% effective at preventing death.

    R&D expense decline
    6%
    2023 to 2024

    R&D declined to $4.5 billion in 2024.

    SG&A expense decline
    24%
    2023 to 2024

    Through a variety of cost-out initiatives.

    Total GAAP expense reduction
    over $6 billion55% reduction
    2023 to 2027

    Represents a 55% reduction over 4 years.

    GAAP expense reduction (2024)
    $4 billion
    FY24

    Realized in 2024, largest driver from reductions in cost of sales.

    R&D as percentage of expense base
    nearly 2/3
    current

    Represents the largest future source of cost reductions.

    Industry KPIs

    11
    MetricValueDetails
    EPS$2.52USD/share
    Gross margin—
    Tariff impact—
    Revenue net sales$108 millionUSD
    Effective tax rate—
    Cash investments balance$8.4 billionUSD
    Regulatory approvals filingsmRESVIA approvals in Australia, Taiwan, U.K., Switzerland
    Therapeutic drug market share38%%
    Free cash flow operating cash flow—
    Geographic regional revenue growth—
    Clinical trial efficacy safety datarobust antibody responses

    Deals & partnerships

    2
    MerckCollaboration on individualized neoantigen therapy (Intismeran) programs.

    Several late-stage studies underway for Intismeran, including Phase III in adjuvant melanoma and non-small cell lung cancer, and Phase II in bladder cancer and renal cell carcinoma.

    ImmaticsCollaboration on engineered T cell therapy booster (mRNA-4203).

    mRNA-4203 is designed to boost the activity of an engineered T cell therapy to improve its persistence and effectiveness. An IND is open for this program.

    Risks & headwinds

    7
    Seasonal nature of respiratory vaccine businessQ1 FY25

    Q1 FY25 total revenue decreased 35% year-over-year to $108 million

    Mitigation: Expect most sales in the second half of the year; mRESVIA approvals in new geographies.

    Lower vaccination ratesQ1 FY25

    Lower vaccination rates compared to Q1 FY24

    Mitigation: Transition of COVID into routine seasonal vaccination patterns; focus on making products available for the coming fall season.

    Uncertainties in market environment for guidanceFY25

    Full-year 2025 total revenue guidance range of $1.5 billion to $2.5 billion

    Mitigation: Focus on controllable factors like cost base and efficiency.

    Flu-COVID combination vaccine (mRNA-1083) regulatory timeline extensionFY26

    Review time line extended into 2026

    Mitigation: Will complete Phase III flu efficacy analysis by summer 2025 and submit data to FDA; engage constructively with FDA on submission approach.

    Norovirus vaccine approval timing uncertaintyFY26-FY27

    Targeted approval could be in 2026 or 2027

    Mitigation: Timing dependent on case accrual; expect more clarity on pace and readout timing later this year.

    Potential for GBS cases in norovirus trialongoing

    One GBS case identified in prior norovirus trial

    Mitigation: Clinical hold lifted; actively monitoring for additional cases in ongoing Phase III study; assessing causality.

    Regulatory uncertainties regarding vaccine trial requirementsfuture

    Discussion around potential requirement for placebo-controlled trials

    Mitigation: Moderna's current trials (COVID, RSV, CMV, norovirus) are already placebo-controlled; commitment to provide data regulators need.

    What to watch in Q2 FY25

    5

    Next-gen COVID vaccine (mRNA-1283) regulatory decision

    By Q2 FY25 end
    CurrentPDUFA date May 31
    TargetApproval decision

    Why it matters

    Key regulatory approval for a new COVID vaccine, impacting future sales and market position.

    Our Next-gen COVID vaccine has a PDUFA date of May 31.

    Q&A highlights

    5

    Why did FDA require Phase III flu efficacy data for the Flu-COVID combo, extending the timeline? Are there broader risks to the vaccine business outlook under the new administration?

    Stephen Hoge explained that the flu efficacy study has rapidly accrued cases, and the data will be available soon. It makes scientific sense for this data to be part of the review for the combination vaccine, leading to an extended timeline into 2026. He noted that interactions with FDA remain 'business as usual' and constructive. He also highlighted the continued need for COVID vaccination, citing thousands of deaths weekly in winter and the 96% effectiveness of their updated vaccine against death.

    “for a whole bunch of, I think, quite reasonable scientific reasons, it makes sense that we review that as a part of the combination vaccine study.”

    asked by Salveen Richter · answered by Stephen Hoge

    2 min read5 chapters

    Detailed Narrative

    01

    Q1 Performance and Cost Efficiency

    Moderna's Q1 FY25 results were in line with expectations, reflecting the seasonal nature of its respiratory vaccine business. The company reported $108 million in total revenue and a net loss of $1 billion, an improvement of $204 million year-over-year. A key highlight was the continued financial discipline, with combined R&D, SG&A, and cost of sales decreasing by 19% year-over-year, marking the third consecutive quarter of double-digit reductions.

    02

    Commercial Product Expansion

    The company expanded market access for its commercial products, securing a tender opportunity for COVID vaccines in Europe. mRESVIA, its RSV vaccine, received new approvals in Australia, Taiwan, the U.K., and Switzerland, adding to its 2024 approvals in the U.S., EU, and Canada, positioning it for stronger competition in the respiratory vaccine market.

    03

    Pipeline Advancement and Oncology Focus

    Moderna is advancing its pipeline with a strategic focus on oncology. The company announced the expansion of its oncology portfolio with the Checkpoint medicine (mRNA-4359), which is now in Phase II studies for metastatic melanoma and non-small cell lung cancer. This prioritization reflects encouraging early data and a strategy to build out its therapeutics pipeline, including two novel cancer antigen therapies (mRNA-4106 and mRNA-4203) entering clinical development.

    04

    Regulatory Timelines and Pipeline Optimization

    Regulatory timelines for several key programs have been updated. The Flu-COVID combination vaccine (mRNA-1083) now has an extended review timeline into 2026, pending Phase III flu efficacy data. Norovirus approval is projected for 2026 or 2027, dependent on case accrual. The company also deprioritized the Flu-COVID combination vaccine for younger adults (18-49) to focus efforts on older adult populations and reallocate investment to the oncology pipeline.

    05

    Long-term Financial Outlook

    Moderna reiterated its full-year 2025 financial guidance and provided updated cost reduction targets for 2026 and 2027. The company plans an additional $1.4 billion to $1.7 billion in cost reductions by 2027, aiming for a 2027 cash cost of approximately $4.2 billion. This aggressive cost management strategy underpins its commitment to achieve cash breakeven by 2028, with total GAAP expense reductions of over $6 billion from 2023 to 2027.

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