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    MRNA
    Earnings call· Mar 2026(Q1 FY26)

    Moderna Q1 FY26 earnings call MRNA

    May 1, 2026 Source

    Executive summary

    Moderna Q1 FY26 — Strong Revenue Growth and Pipeline Advancement

    Moderna delivered a strong Q1 FY26, exceeding revenue guidance with $0.4 billion, primarily from international partnerships, and reiterated its full-year revenue growth target. The company maintained financial discipline, reducing adjusted cash costs, while advancing its pipeline with new product approvals in the EU and expanded oncology trials. Despite a GAAP net loss driven by a litigation settlement, Moderna ended the quarter with a robust cash position, signaling continued investment in its diverse portfolio.

    Highlights

    5

    • Total revenue grew significantly to $0.4 billion, exceeding guidance, driven by long-term strategic partnerships.

    • Adjusted cash cost reduced by 26% year-over-year in Q1, on track for full-year objective of approximately $4.2 billion.

    • Achieved EU approval for mComvriax (flu+COVID combo vaccine) and mRESVIA (RSV vaccine), marking Moderna's fourth approved product.

    • Initiated a new Phase III clinical trial for Intismeran in non-small cell lung cancer (Stage 1 disease), expanding into earlier-stage oncology.

    • Ended the quarter with a strong cash and investments balance of $7.5 billion.

    Concerns

    3

    • Reported a net loss of $1.3 billion on a GAAP basis, primarily driven by an $878 million litigation settlement charge.

    • Cash and investments decreased to $7.5 billion from $8.1 billion at the end of 2025, primarily due to operating losses and R&D investment.

    • Cost of sales projection increased from $0.9 billion to $1.8 billion for FY26 due to the $0.9 billion litigation settlement charge.

    Guidance & targets

    13
    CategoryTargetConfidence
    Full-year 2026 revenue growth
    up to 10%
    high materiality
    High
    Full-year 2026 adjusted cash costs
    approximately $4.2 billion
    medium materiality
    High
    Full-year 2026 cost of sales
    $1.8 billion
    medium materiality
    High
    Full-year 2026 R&D expenses
    approximately $3 billion
    medium materiality
    High
    Full-year 2026 SG&A expenses
    approximately $1 billion
    medium materiality
    High
    Full-year 2026 GAAP operating expenses (excluding litigation charge)
    $4.9 billion
    medium materiality
    High
    Full-year 2026 cash and investments
    between $4.5 billion to $5 billion
    high materiality
    High
    Q2 2026 revenue
    between $50 million and $100 million
    medium materiality
    High
    Timing of R&D spend
    slightly weighted more to the second half of the year
    low materiality
    Medium
    Commercial spend weighting
    more heavily weighted to the second half of the year
    low materiality
    Medium
    Full-year 2026 revenue geographic mix
    roughly 50% from the U.S. market, and 50% from international markets
    medium materiality
    High
    Full-year 2026 revenue guidance assumptions
    no revenue from our flu vaccine or [indiscernible]
    low materiality
    High
    Litigation settlement payment timing
    $950 million
    high materiality
    High

    Segment performance

    2
    SegmentRevenueYoYQoQMargin
    International Markets
    Strong international revenue performance primarily driven by deliveries under long-term strategic partnerships.
    Q1 FY26 Revenue Mix: 80%
    		————
    United States
    U.S. market contributed 20% of Q1 revenue.
    Q1 FY26 Revenue Mix: 20%
    		————

    Operational metrics

    14
    Total revenue
    $400 millionincreased $300 million vs prior year
    Q1 FY26

    Exceeded guidance, driven primarily by execution of long-term strategic partnership with the U.K. government.

    Net loss (GAAP)
    $1.3 billionvs $1 billion prior year
    Q1 FY26

    Primarily driven by the litigation settlement.

    Net loss (excl. litigation settlement)
    $0.5 billiondown over 50% vs prior year
    Q1 FY26

    Excluding the previously announced Arbutus litigation settlement.

    Cost of sales (GAAP)
    $955 million
    Q1 FY26

    Includes $878 million related to the previously disclosed litigation settlement.

    Cost of sales (excl. litigation settlement)
    $77 million14% year-over-year decline
    Q1 FY26

    Driven by reduced unutilized capacity costs, losses on purchase commitments and inventory write-downs, partially offset by higher sales volume.

    R&D expenses
    $649 million24% decrease compared to last year
    Q1 FY26

    Driven by lower clinical development and manufacturing costs as large Phase III respiratory programs and CMV Phase III study wind down, partially offset by higher post-marketing commitments from COVID products.

    SG&A expenses
    $173 million18% decrease compared to last year
    Q1 FY26

    Driven by lower spend across all functions, reflecting continued cost discipline.

    Cash and investments
    $7.5 billioncompared to $8.1 billion at the end of 2025
    Q1 FY26 end

    Decrease primarily driven by operating losses as the company continues to invest in R&D and advance its pipeline.

    Litigation settlement charge (recognized in Q1 cost of sales)
    $878 million
    Q1 FY26

    Part of the $950 million lump sum payment due in Q3 2026.

    Litigation settlement remaining amortization
    $72 million
    over next 3 years

    Remaining portion of the $950 million settlement not recognized in Q1.

    FY25 sales outside United States
    $700 million
    FY25

    Historical comparison provided to contextualize 2026 revenue phasing.

    FY25 US sales
    $1.2 billion
    FY25

    Historical comparison provided to contextualize 2026 revenue phasing.

    First half 2026 revenue
    $440 million to $490 million
    H1 FY26

    Combined Q1 actual and Q2 guidance.

    European respiratory vaccines market size
    $1.8 billion
    annual

    Target market for newly approved combination COVID vaccine and RSV vaccine in Europe.

    Industry KPIs

    6
    MetricValueDetails
    Capital deployment$7.5 billionUSD
    Launch access metrics—
    Pipeline read out calendar—
    Product franchise net sales$400 millionUSD
    Regulatory approvals filings—
    Clinical trial efficacy safety data1.5%hazard ratio

    Product announcements

    2
    ProductTypeDetails
    mComvriax (flu+COVID combo vaccine)launch
    mRESVIA (RSV vaccine)expansion

    Deals & partnerships

    1
    Arbutuslitigation settlement$950 million

    Resolving all litigation worldwide. Moderna will appeal to the Federal Circuit to argue its government contractor immunity defense. If Moderna ultimately prevails, no further payments will be due. If liability is affirmed, an additional payment of up to $1.3 billion is possible.

    Risks & headwinds

    3
    Potential additional payment for Arbutus litigationLate 2027, maybe into 2028 (resolution of appeal)

    Up to $1.3 billion

    Mitigation: Moderna's legal team believes a loss related to the Section 1498 proceeding is not probable, and accordingly, no charge has been recorded.

    Potential future declines in COVID vaccination ratesFY26

    Factored into FY26 revenue guidance

    Mitigation: Offset by increased penetration of mNEXSPIKE and revenue from long-term strategic partnerships.

    Geopolitical developments (Middle East conflict)FY26

    No material impacts to 2026 financial outlook currently

    Mitigation: Company will continue to monitor geopolitical developments.

    Q&A highlights

    7

    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

    2 min read6 chapters

    Detailed Narrative

    01

    Q1 Financial Performance

    Moderna reported Q1 revenue of $400 million, surpassing guidance, largely due to international strategic partnerships. The company recorded a GAAP net loss of $1.3 billion, primarily impacted by an $878 million litigation settlement charge. Excluding this, the net loss was $0.5 billion, a 50% reduction year-over-year, demonstrating improved underlying financial performance.

    02

    Cost Management and Cash Position

    Cost reduction efforts continued, leading to a 26% year-over-year decrease in adjusted cash costs in Q1, excluding the settlement. This keeps the company on track for its full-year adjusted cash cost target of approximately $4.2 billion. Moderna ended the quarter with $7.5 billion in cash and investments, down from $8.1 billion at year-end 2025, reflecting R&D investments and operating losses while maintaining a strong balance sheet.

    03

    Pipeline Expansion in Oncology

    The oncology pipeline saw significant advancement with the initiation of a new Phase III clinical trial for Intismeran in high-risk Stage 1 non-small cell lung cancer, evaluating it as a monotherapy. This expands the program into earlier disease stages, leveraging Intismeran's strong safety and tolerability profile. Updates on Intismeran in adjuvant melanoma (5-year data) and mRNA-4359 (Phase II) were also highlighted, showcasing a broad late-stage oncology portfolio.

    04

    Infectious Disease Portfolio Milestones

    Moderna achieved key regulatory approvals in the European Union for mComvriax (flu+COVID combo vaccine) and mRESVIA (RSV vaccine), marking its fourth approved product. These are expected to drive growth in the EU starting in 2027, positioning Moderna well in the European respiratory vaccines market. The seasonal flu vaccine mRNA-1010 has a PDUFA date of August 5 in the U.S., and the pandemic flu program mRNA-1018 initiated its Phase III study.

    05

    Rare Disease Program Updates

    The propionic acidemia (PA) program is fully enrolled in its potentially registrational study, with pivotal data expected later in 2026. The methylmalonic acidemia (MMA) program's registrational trial start has been deferred until after the PA program's pivotal readout, reflecting a strategic sequencing of rare disease development to optimize resource allocation and leverage learnings.

    06

    Strategic Partnerships and Market Access

    The company delivered its first shipment under a strategic partnership in the United Kingdom, contributing to strong international revenue. Efforts are underway to secure market access, pricing, and reimbursement for newly approved vaccines in Europe, targeting the large $1.8 billion annual European respiratory vaccines market for future revenue growth. This includes building economic value stories for payers and healthcare systems.

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