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    MDGL
    Earnings call· Mar 2026(Q1 FY26)

    MADRIGAL PHARMACEUTICALS Q1 FY26 earnings call MDGL

    May 6, 2026 Source

    Executive summary

    Madrigal Pharmaceuticals Q1 FY26 — Rezdiffra Blockbuster Status & Pipeline Expansion

    Madrigal Pharmaceuticals reported a strong start to FY26, with Rezdiffra achieving blockbuster status and demonstrating significant patient growth. The company is strategically expanding its pipeline through targeted business development, aiming to solidify its leadership in the rapidly growing MASH market. While profitability is not expected in the current fiscal year due to investments, management anticipates it will be inevitable beyond 2026.

    Highlights

    5

    • Rezdiffra achieved blockbuster status, generating over $1.1 billion in net sales in the last 12 months.

    • First quarter 2026 net sales for Rezdiffra were $311 million, representing year-over-year growth of 127%.

    • The company ended Q1 FY26 with more than 42,250 active patients on Rezdiffra, a 2.5x increase compared to Q1 FY25.

    • The U.S. addressable MASH market expanded nearly 50% from 315,000 patients at the end of 2023 to 460,000 patients at the end of 2025.

    • Gross to net discount is now expected to be in the mid- to high 30s for the rest of 2026, better than anticipated.

    Concerns

    2

    • Net loss for the first quarter of 2026 was $94.4 million, inclusive of $54.3 million in one-time upfront business development expenses.

    • The company does not expect to be profitable in 2026, with Q2 SG&A expenses anticipated to be higher due to marketing timing.

    Guidance & targets

    10
    CategoryTargetConfidence
    Gross to net discount
    mid- to high 30s
    medium materiality
    High
    Full year R&D expenses
    roughly the same as 2025
    medium materiality
    High
    Full year SG&A expenses
    increase compared to 2025
    medium materiality
    High
    Profitability
    not profitable in 2026
    high materiality
    High
    Profitability
    inevitable beyond 2026
    high materiality
    High
    Maestro MASH outcomes trial readout
    2027
    high materiality
    High
    Rezdiffra F2/F3 study data
    2028
    high materiality
    High
    D2 inhibitor drug-drug interaction study
    on track to begin in the fourth quarter of this year
    medium materiality
    High
    D2 inhibitor Phase II combination study
    initiate in 2027
    medium materiality
    High
    Oral GLP-1 Phase I single ascending dose study
    initiate later this quarter
    medium materiality
    High

    Segment performance

    2
    SegmentRevenueYoYQoQMargin
    F2/F3 MASH Market
    The U.S. addressable market for F2/F3 MASH patients seen by target specialists grew nearly 50% from end 2023 to end 2025. Diagnosis and Rezdiffra penetration rates remain low, indicating significant growth potential.
    Addressable patients (end 2025): 460,000Addressable patients (end 2023): 315,000Diagnosis rate: just over 10%Rezdiffra penetration: just under 10% of 460,000 addressable patients
    		————
    F4C MASH Market
    This represents an untapped market with no approved therapies, offering a significant opportunity to double Rezdiffra's potential.
    Patients under specialist care in U.S.: 245,000
    		————

    Operational metrics

    18
    Rezdiffra Net Sales (Trailing 12 Months)
    $1.1B
    LTM Q1 FY26

    Rezdiffra has achieved blockbuster status.

    Rezdiffra Net Sales
    $311.3Mup 127% YoY
    Q1 FY26

    Strong start to 2026, reinforcing tracking in line with or exceeding best-in-class specialty launches.

    Active Patients on Rezdiffra
    42,2502.5x increase YoY
    End Q1 FY26

    Reflects strong execution and continued demand in a market that didn't exist before Rezdiffra's approval.

    US Addressable MASH Market Growth
    nearly 50%
    2023-2025

    Market expanded from 315,000 patients at end of 2023 to 460,000 patients at end of 2025.

    MASH Diagnosis Rate
    just over 10%
    Current

    Indicates significant room for market expansion.

    Rezdiffra Penetration
    just under 10%
    Current

    Low penetration rate suggests substantial future growth opportunity.

    Rezdiffra Prescribers
    over 10,000
    Current

    Indicates broad adoption among healthcare professionals.

    GLP-1 Concomitant Use with Rezdiffra
    25%+
    Current

    Many patients are already on GLP-1s when starting Rezdiffra, and this trend is expected to increase.

    PNPLA3 Mutation Prevalence
    approx. 30%
    Current

    This subset of patients has a twofold higher risk of liver-related events.

    ARO-PNPLA3 Liver Fat Reduction
    up to 46%
    12 weeks

    Demonstrated in Phase I studies, supporting potential for improved efficacy in combination with Rezdiffra.

    R&D Expenses
    $108.7Mvs $44.2M in prior year
    Q1 FY26

    Increase primarily due to one-time upfront business development expenses.

    Business Development Expenses (Upfront)
    $54.3M
    Q1 FY26

    Included in Q1 R&D expenses.

    ARO-PNPLA3 Upfront Payment
    $25M
    Q2 FY26

    Upfront payment and related expenses for ARO-PNPLA3 will be recorded in Q2.

    SG&A Expenses
    $268.5Mvs $167.9M in prior year
    Q1 FY26

    Increase primarily due to continued investment in commercial activities for Rezdiffra, including endocrinology field force expansion and DTC campaign.

    Net Loss
    $94.4Mvs $73.2M in prior year
    Q1 FY26

    Inclusive of one-time upfront business development expenses of $54.3 million.

    Cash, Cash Equivalents, Restricted Cash and Marketable Securities
    $817.9Mvs $988.6M at end of 2025
    End Q1 FY26

    Balance reflects several quarter-specific uses of cash, including one-time upfront business development payments and timing of API purchases.

    Cost of Sales
    $26.8Mvs $4.5M in prior year
    Q1 FY26

    Primarily reflects royalties owed to Roche.

    Pipeline Investment
    under $300M
    Last 10 months

    Amount spent to assemble a leading pipeline of over 10 programs.

    Industry KPIs

    10
    MetricValueDetails
    Launch access metricsgreat access
    Pipeline read out calendar2027 (F4C study), 2028 (F2/F3 study)
    Product franchise net sales$1.1BUSD
    Regulatory approvals filings—
    Peak long term sales guidancemega blockbuster
    Therapeutic drug market sharejust under 10%%
    Prescription volume new startsbest NBRx month since launch
    Clinical trial efficacy safety dataup to 46%%
    Collaboration milestone royalty revenue—
    Cumulative patients uptake since launch42,250patients

    Deals & partnerships

    1
    ArrowheadIn-licensing of ARO-PNPLA3, a clinical stage siRNA asset.$25M upfront payment

    The asset targets a mutation in the PNPLA3 gene, a genetically validated driver of disease in a meaningful subset of patients. It has completed Phase I studies and demonstrated significant liver fat reduction.

    Risks & headwinds

    4
    Q1 effect on patient addsQ1 FY26

    Lower patient adds compared to some recent quarters

    Mitigation: This is a typical Q1 effect due to benefit plan changes and insurance reverifications; momentum is strong into Q2.

    Net loss due to business development expensesQ1 FY26

    $94.4M net loss in Q1 FY26, inclusive of $54.3M one-time upfront BD expenses

    Mitigation: These are strategic investments to build the pipeline; profitability is expected beyond 2026.

    Higher SG&A expensesQ2 FY26

    Q2 FY26 SG&A expenses expected to be higher

    Mitigation: Due to timing of certain marketing expenses, including DTC, then steadies for the rest of the year. Part of supporting the Rezdiffra launch and long-term growth.

    Unprofitability in current fiscal yearFY26

    Not profitable in 2026

    Mitigation: Company is focused on supporting top-line growth and building its pipeline; profitability is believed to be inevitable beyond 2026.

    What to watch in Q2 FY26

    5

    Rezdiffra Q2 patient adds and net sales growth

    Q2 FY26
    Current42,250 active patients (end Q1 FY26), $311.3M net sales (Q1 FY26)
    TargetContinued steady patient adds and robust net sales growth

    Why it matters

    To confirm the strong momentum reported for Q2 and assess the impact of the typical Q1 effect on patient growth.

    And importantly, we are seeing that momentum carried into the second quarter. [...] For the rest of 2026, we expect to steadily add patients and generate robust net sales growth.

    Q&A highlights

    6

    What are the Q2 trends for Rezdiffra patient adds, and what impact is Wegovy having on Rezdiffra's market performance?

    Q2 is off to a strong start with steady patient adds. Wegovy (GLP-1s) has not negatively impacted Rezdiffra; most patients are already on GLP-1s when they present with F2-F3 MASH. April saw the best NBRx month since launch, indicating continued strong momentum.

    “As we exit April, it's been our best NBRx month since launch. So we're really excited about the rest of the year. We'll be steadily adding patients, just as we've said from [indiscernible]”

    asked by Prakhar Agrawal · answered by William Sibold

    2 min read5 chapters

    Detailed Narrative

    01

    Rezdiffra Commercial Performance and Market Expansion

    Rezdiffra has achieved blockbuster status with over $1.1 billion in net sales in the last 12 months, driven by strong Q1 FY26 sales of $311 million, a 127% year-over-year increase. The company ended Q1 with over 42,250 active patients, representing a 2.5x increase from Q1 FY25. The U.S. addressable MASH market has grown nearly 50% from 315,000 patients at the end of 2023 to 460,000 patients at the end of 2025, with Rezdiffra penetration still under 10% and diagnosis rates just over 10%, indicating substantial future growth opportunity.

    02

    Strategic Pipeline Development and R&D Goals

    Madrigal's R&D strategy focuses on delivering an industry-leading pipeline in MASH, with Rezdiffra as the foundational therapy. The strategy includes four key goals: delivering outcomes data and full approval for Rezdiffra across F2-F4C, advancing complementary mechanisms for combination therapies, remaining modality-agnostic (e.g., siRNA assets), and leveraging expertise for efficient clinical trials. The company has assembled a pipeline of over 10 programs for under $300 million, demonstrating capital efficiency.

    03

    F4C Opportunity and Maestro Outcomes Trial

    The F4C (well-compensated MASH cirrhosis) market represents a significant untapped opportunity, with approximately 245,000 patients under specialist care in the U.S. and no approved therapies. This indication could double Rezdiffra's market opportunity. The Maestro MASH outcomes trial in F4C is event-driven and expected to read out in 2027, with confidence informed by 2-year open-label data from the Maestro NAFLD-1 trial, which showed 65% of patients with clinically significant portal hypertension (CSPH) at baseline shifted into lower-risk categories by year 2.

    04

    ARO-PNPLA3 In-licensing and Combination Strategy

    Madrigal in-licensed ARO-PNPLA3, a clinical-stage siRNA from Arrowhead, targeting the PNPLA3 gene mutation. This mutation is prevalent in approximately 30% of F2-F3 MASH patients, particularly Hispanic patients, and is associated with a twofold higher risk of liver-related events. Phase I data showed a single dose reduced liver fat by up to 46% at 12 weeks. The strategy is to combine Rezdiffra with targeted agents like ARO-PNPLA3 to improve efficacy in specific patient subsets or broadly across the population.

    05

    Financial Performance and Outlook

    First quarter 2026 net sales were $311.3 million. Operating expenses included $34 million in noncash stock-based compensation. R&D expenses increased to $108.7 million (from $44.2 million YoY), primarily due to $54.3 million in one-time📎 upfront business development expenses. SG&A expenses rose to $268.5 million (from $167.9 million YoY) due to commercial activities and endocrinology field force expansion. The company ended Q1 with $817.9 million in cash and equivalents, down from $988.6 million at year-end 2025, reflecting BD payments and API purchases. Madrigal expects to be unprofitable in 2026 but anticipates profitability beyond that.

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