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    MIRM
    Earnings call· Dec 2025(Q4 FY25)

    Mirum Pharmaceuticals Q4 FY25 earnings call MIRM

    Feb 25, 2026 Source

    Executive summary

    Mirum Pharmaceuticals Q4 FY25 — Strong Sales Growth and Pivotal Pipeline Readouts Ahead

    Mirum Pharmaceuticals concluded FY25 with robust net product sales growth, driven by LIVMARLI and bile acid medicines, and provided confident 2026 guidance. The company significantly advanced its pipeline, notably with the Brelovitug acquisition and multiple near-term registrational readouts for Volixibat and LIVMARLI, positioning it for a pivotal growth phase. While R&D investments are increasing for pipeline advancement, the company maintains a strong financial position.

    Highlights

    5

    • Delivered $521 million in net product sales for FY25, exceeding the upper end of guidance.

    • Achieved 55% year-over-year growth in total net product sales for FY25, reaching $521 million.

    • Ended 2025 with $391 million in cash, cash equivalents, and investments, up from $293 million at the end of 2024.

    • Completed enrollment for Volixibat VISTAS study in PSC, with topline data expected in Q2 2026.

    • Successfully integrated the Brelovitug program, adding 4 potentially registrational clinical readouts expected over the next 18 months.

    Concerns

    3

    • Expect R&D expense to increase by approximately $150 million in 2026, primarily due to Brelovitug clinical program and manufacturing.

    • Anticipate lower revenues from Japan in 2026 compared to $22 million in 2025 due to inventory buildup.

    • Expect a return to positive cash flow from operations in 2027, implying negative cash flow from operations in 2026.

    Guidance & targets

    3
    CategoryTargetConfidence
    Net product sales
    $630 million to $650 million
    high materiality
    High
    R&D expense increase
    approximately $150 million
    medium materiality
    High
    Cash flow from operations
    return to positive cash flow
    high materiality
    High

    Segment performance

    3
    SegmentRevenueYoYQoQMargin
    LIVMARLI U.S.
    Contributed to the strong finish of FY25 net product sales.
    		$245 million———
    LIVMARLI International
    Contributed to the strong finish of FY25 net product sales.
    		$115 million———
    Bile Acid Medicines
    Contributed to the strong finish of FY25 net product sales.
    		$161 million———

    Operational metrics

    16
    Total net product sales
    $521 million55% year-over-year growth
    FY25

    Exceeded the upper end of guidance range.

    Total net product sales
    $149 millioncompared to $99 million the year before
    Q4 FY25

    Strong performance in the fourth quarter.

    Total operating expense
    $543 million
    FY25

    Includes R&D, SG&A, and cost of sales.

    Total operating expense
    $153 million
    Q4 FY25
    R&D expense
    $186 million
    FY25

    Component of full year operating expense.

    SG&A expense
    $257 million
    FY25

    Component of full year operating expense.

    Cost of sales
    $100 million
    FY25

    Component of full year operating expense.

    Noncash expenses
    $95 million
    FY25

    Included in full year operating expense.

    Intangible amortization and other noncash expenses
    $24 million
    FY25

    Reflected in cost of sales.

    Commercial cash contribution margin
    approximately 55%significant increase from the prior year
    2025

    Reflects solid operating performance.

    Cash, cash equivalents and investments
    $391 millionup from $293 million at the end of 2024
    end of 2025

    Reflecting solid operating performance.

    Gross proceeds from private placements
    $268.5 million
    recent

    Concurrent with the closing of the Bluejay acquisition, effectively covering the cash outlay.

    Japan revenue
    $22 million
    last year

    Due to inventory buildup; expected to be lower this year.

    Portfolio potential revenue
    over $4 billion
    long-term

    Built through team's insight and hard work.

    Brelovitug viral response rate
    100%
    week 48

    Observed in hepatitis delta, contributing to potential best-in-class profile.

    Brelovitug composite endpoint
    65% to 82%
    24-week

    Composite endpoint of virologic response and ALT normalization for Brelovitug in hepatitis delta.

    Industry KPIs

    5
    MetricValueDetails
    Pipeline read out calendar4 potentially registrational clinical readouts
    Product franchise net sales$360 millionUSD
    Regulatory approvals filingsCTEXLI approved for CTX
    Peak long term sales guidanceover $4 billionUSD
    Clinical trial efficacy safety data100%%

    Product announcements

    2
    ProductTypeDetails
    CTEXLIexpansion
    LIVMARLIupdate

    Deals & partnerships

    1
    BluejayAcquisition of the Phase III Brelovitug program for chronic hepatitis delta virus.

    Meaningfully expanded our pipeline with the addition of the Phase III Brelovitug program for chronic hepatitis delta virus.

    Risks & headwinds

    3
    Increased R&D expense for Brelovitug programFY26

    approximately $150 million increase

    Mitigation: fully funded

    Lower Japan revenues due to prior inventory buildupFY26

    lower revenues from Japan

    Mitigation: launch in Japan is going as expected

    Negative cash flow from operationsFY26

    Implied for 2026

    Mitigation: expect a return to positive cash flow in 2027

    What to watch in Q1 FY26

    4

    Volixibat VISTAS (PSC) topline data

    Q2 2026
    CurrentEnrollment completed
    TargetPositive topline data

    Why it matters

    This readout is for a disease with no approved therapies and could significantly expand Volixibat's market opportunity.

    Beginning in the second quarter, we expect to report top line data from the Volixibat VISTAS in PSC

    Q&A highlights

    6

    How is Mirum thinking about pricing Volixibat, especially for PSC where there are no approved therapies, compared to PBC pricing benchmarks?

    Mirum considers PPARs in PBC as a good planning benchmark but will make a final pricing decision closer to launch, especially given Volixibat's unique positioning in PSC with no approved therapies.

    “The PPARs in PBC really are good planning benchmark to think about, but that's not -- certainly not our final guidance or decision on it. We'll take that as we have data in hand and are closer to launch to make the final decision.”

    asked by James Condulis · answered by Christopher Peetz

    2 min read6 chapters

    Detailed Narrative

    01

    FY25 Performance Highlights

    Mirum Pharmaceuticals reported strong financial results for FY25, with total net product sales reaching $521 million, exceeding the upper end of their guidance. This performance was fueled by LIVMARLI sales of $245 million in the U.S. and $115 million internationally, alongside $161 million from bile acid medicines. The company achieved 55% year-over-year growth in net product sales and ended the year with a robust cash position of $391 million.

    02

    Pipeline Expansion and Strategic Acquisitions

    The company significantly expanded its pipeline with the acquisition of the Phase III Brelovitug program for chronic hepatitis delta virus, a rare disease with limited treatment options. This strategic addition is expected to create substantial operating leverage and complements the upcoming Volixibat launch. The integration of the acquired team has progressed smoothly, adding to Mirum's focus on rare disease medicines.

    03

    Near-Term Clinical Readouts

    Mirum anticipates a pivotal 18 months with four potentially registrational clinical readouts. Key upcoming data include topline results from the Volixibat VISTAS study in PSC and interim results from the AZURE-1 study of Brelovitug in hepatitis delta, both expected in Q2 2026. Full topline results for AZURE-1 and AZURE-4 Phase III trials for Brelovitug are expected in H2 2026.

    04

    Broader Pipeline Progress

    Beyond the immediate readouts, enrollment in the LIVMARLI EXPAND study for rare cholestatic conditions and the Volixibat VANTAGE study in PBC is exceeding expectations, with topline results anticipated in Q4 2026 and H1 2027, respectively. The BLOOM Phase II study for MRM-3379 in Fragile X syndrome is also on track for data in 2027, further diversifying the company's therapeutic areas.

    05

    Financial Strength and Investment Strategy

    Mirum achieved positive cash flow from operations in 2025 and bolstered its balance sheet with $268.5 million from private placements, effectively covering the Bluejay acquisition cost. While R&D expenses are projected to increase by approximately $150 million in 2026, primarily for the Brelovitug program, this investment is fully funded, and the company expects to return to positive cash flow in 2027, demonstrating disciplined spending.

    06

    Market Opportunity and Unmet Needs

    The company highlighted its portfolio's potential to generate over $4 billion in revenue, addressing significant unmet needs in rare diseases. Management emphasized the unique positioning of Volixibat in PSC, where no approved therapies exist, and the potential for Brelovitug to set a new standard of care in hepatitis delta with its impressive response rates and safety profile.

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