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    ARWR
    Earnings call· Jun 2026(Q3 FY26)

    ARROWHEAD PHARMACEUTICALS Q3 FY26 earnings call ARWR

    Aug 4, 2026 Source

    Executive summary

    Arrowhead Pharmaceuticals Q3 FY26 — Strong SHASTA Data and Accelerated sHTG Launch Plans

    Arrowhead Pharmaceuticals reported strong Q3 FY26 results, highlighted by positive Phase III SHASTA data for plozasiran in severe hypertriglyceridemia (sHTG), demonstrating significant triglyceride reduction and acute pancreatitis event reduction. The company acquired a Priority Review Voucher to accelerate regulatory review for sHTG, aiming for a faster market entry. REDEMPLO's FCS launch continues to build momentum, and the broader cardiometabolic pipeline, including ARO-INHBE and ARO-DIMER-PA, shows promising progress, positioning Arrowhead for substantial future growth and market expansion.

    Highlights

    5

    • REDEMPLO Phase III SHASTA-3 and SHASTA-4 studies met primary and all secondary endpoints, showing 79% and 81% median triglyceride reductions, respectively.

    • Plozasiran demonstrated a 78% reduction in cumulative acute pancreatitis events in the broad sHTG population and 100% reduction in the highest risk subgroup.

    • REDEMPLO prescription volume more than doubled quarter-on-quarter, with over 400 unique prescribers and strong payer coverage momentum.

    • Acquired a Priority Review Voucher for $215 million to accelerate sNDA review for plozasiran in sHTG, aiming to shorten approval by 4 months.

    • Pipeline advancements include positive ARO-INHBE Phase I data (44% liver fat reduction), full enrollment of Zodasiran Phase III, and upcoming data readouts for ARO-DIMER-PA and ARO-MAPT in September.

    Concerns

    2

    • Market education for sHTG

    • Uncertainty around MFN (Most Favored Nation) pricing

    Guidance & targets

    10
    CategoryTargetConfidence
    sNDA Submission for Plozasiran in sHTG
    Before the end of 2026
    high materiality
    High
    Zodasiran YOSEMITE Phase III Data Readout
    Q3 2027
    medium materiality
    High
    Zodasiran NDA Filing
    By the end of 2027
    medium materiality
    High
    CTA Filing for New Obesity Candidate
    By the end of this year
    low materiality
    High
    ARO-DIMER-PA Phase I Data Release
    September
    medium materiality
    High
    ARO-MAPT Phase I Data Release (Healthy Volunteers)
    September
    medium materiality
    High
    ARO-ALK7 Data Update
    Fourth quarter
    low materiality
    High
    REDEMPLO EU Reimbursement & Launch
    Country-by-country over approximately the next 12 months, starting with Germany
    medium materiality
    Medium
    Field Personnel Onboarding for sHTG
    Before the end of the year
    medium materiality
    High
    sHTG Launch
    Second quarter of next year
    high materiality
    High

    Segment performance

    1
    SegmentRevenueYoYQoQMargin
    FCS (Familial Chylomicronemia Syndrome)
    Commercial sales of REDEMPLO for FCS more than doubled quarter-on-quarter, with strong momentum continuing into the current quarter. Over 400 unique prescribers have been supported, primarily from preventive cardiology and endocrinology. Payer coverage is progressing rapidly, with favorable policies in place for most significant payers.
    Unique prescribers: >400Weekly new prescriptions: 20-30
    		$2.4M—more than doubled—

    Operational metrics

    25
    Net Loss
    $194.3Mvs $175.2M in Q3 FY25
    Q3 FY26

    GAAP net loss for the quarter. Included due to explicit user request, though typically omitted as a raw GAAP figure.

    Loss Per Share
    $1.36vs $1.26 in Q3 FY25
    Q3 FY26

    GAAP loss per share for the quarter. Included due to explicit user request, though typically omitted as a raw GAAP figure.

    Fully Diluted Weighted Average Shares Outstanding
    143.4Mvs 139M in Q3 FY25
    Q3 FY26

    Included due to explicit user request, though typically omitted as a raw GAAP figure.

    Total Revenue
    $75Mvs $28M in Q3 FY25
    Q3 FY26

    Total revenue for the quarter, driven by license and collaboration agreements and commercial sales. Included due to explicit user request, though typically omitted as a raw GAAP figure.

    Total Operating Expenses
    $245Mvs $193M in Q3 FY25
    Q3 FY26

    Total operating expenses for the quarter. Included due to explicit user request, though typically omitted as a raw GAAP figure.

    R&D Expense
    $198Mvs $162M in Q3 FY25
    Q3 FY26

    R&D expense for the quarter, primarily driven by increased candidate costs and headcount. Included due to explicit user request, though typically omitted as a raw GAAP figure.

    SG&A Expense
    $47Mvs $31M in Q3 FY25
    Q3 FY26

    SG&A expense for the quarter, driven by investments in REDEMPLO commercialization. Included due to explicit user request, though typically omitted as a raw GAAP figure.

    Cash and Investments Balance
    $1.6B
    as of June 30, 2026

    Cash and investments on hand at quarter end, providing significant financial flexibility.

    Deferred Revenue (Novartis)
    $125M
    as of June 30, 2026

    Remaining deferred revenue from the initial $200 million cash received upfront from Novartis, to be recognized over time.

    Priority Review Voucher Cost
    $215M
    Q4 FY26 (expected closing)

    Cost to acquire an FDA Priority Review Voucher, expected to close in fiscal Q4 2026.

    Priority Review Voucher ROI
    >3x
    long-term

    Expected return on investment for the Priority Review Voucher, based on increased present value of REDEMPLO from accelerated launch.

    REDEMPLO Prescription Volume Growth
    doubledquarter-on-quarter
    Q3 FY26

    Prescription volume for REDEMPLO in FCS has more than doubled over the fiscal third quarter.

    REDEMPLO Unique Prescribers
    >400
    Q3 FY26

    Number of unique prescribers for REDEMPLO in FCS.

    REDEMPLO Weekly New Prescriptions
    20-30
    Q3 FY26

    Approximate weekly run rate for new REDEMPLO prescriptions.

    REDEMPLO WAC
    $45,000
    current

    Wholesale Acquisition Cost for REDEMPLO under the One REDEMPLO unified pricing model.

    Plozasiran Peak Sales Potential
    $3B-$4B
    peak

    Estimated peak sales potential for plozasiran in sHTG, primarily U.S.-based.

    ARO-INHBE Liver Fat Reduction
    44%placebo-adjusted
    Phase I/IIa interim data

    Placebo-adjusted post-dose reduction in liver fat in a small subgroup of obese patients with elevated baseline liver fat receiving ARO-INHBE monotherapy.

    ARO-INHBE Active and E Reductions
    >85%
    Phase I/IIa interim data

    Mean maximum reduction in active and E achieved by ARO-INHBE after a single 400mg dose.

    ARO-MAPT Target Knockdown
    50-60%
    target

    Target level of total tau knockdown for ARO-MAPT, based on levels that have shown clinical improvement in other studies.

    Sales Force Target HCPs
    20,000+vs 5,000 currently
    future

    Anticipated expansion of the sales force to address a broader target audience for sHTG, including specialists and primary care physicians.

    Zodasiran YOSEMITE Enrollment
    70vs 60 target
    mid-July

    Number of patients enrolled in the Phase III YOSEMITE study for Zodasiran, exceeding the initial target due to strong demand.

    ARO-PNPLA3 Liver Fat Reductions
    up to 46%
    Phase I data

    Liver fat reductions observed after a single dose of ARO-PNPLA3 in homozygous carriers of the PNPLA3 I148M variant.

    ARO-PNPLA3 Milestones
    up to $975M
    future

    Potential development, regulatory, and sales milestones from the licensing agreement with Madrigal for ARO-PNPLA3.

    ARO-PNPLA3 Royalties
    high single digits to mid-teens
    future

    Tiered royalties on future commercial sales from the licensing agreement with Madrigal for ARO-PNPLA3.

    Total Clinical Candidates
    23
    by year-end 2026

    Expected number of individual drug candidates in clinical trials by the end of 2026.

    Industry KPIs

    7
    MetricValueDetails
    Launch access metricsFavorable policies
    Pipeline read out calendarMultiple readouts
    Regulatory approvals filingsREDEMPLO approved in Australia (May) and EU (June)
    Peak long term sales guidance$3B-$4BUSD/year
    Prescription volume new starts20-30new prescriptions/week
    Clinical trial efficacy safety data79% and 81% median TG reduction%
    Collaboration milestone royalty revenue$25MUSD

    Deals & partnerships

    2
    MadrigalExclusive worldwide license agreement for ARO-PNPLA3$25M upfront payment

    Arrowhead received a $25 million upfront payment and is eligible for substantial milestones and royalties. Phase I data showed liver fat reductions of up to 46% after a single dose in homozygous carriers of the PNPLA3 I148M variant.

    SanofiLicense agreement for REDEMPLO in Greater China

    Sanofi leads commercialization of REDEMPLO in Greater China under an existing license agreement.

    Risks & headwinds

    2
    Market education for sHTGInitial launch period

    Relatively slow ramp

    Mitigation: Company is in the 'education business' to help physicians and patients understand the risk and treatment need for elevated triglycerides.

    Uncertainty around MFN (Most Favored Nation) pricingOngoing

    Very difficult to know how these are going to be pursued in ex U.S. markets and what kind of revenue we're going to see outside the U.S. markets.

    Mitigation: Not explicitly stated, but implies a focus on U.S. market for revenue projections.

    What to watch in Q4 FY26

    5

    ARO-DIMER-PA Phase I Data

    September
    CurrentNearing full enrollment
    TargetEarly data release

    Why it matters

    This is the first clinical readout for a dual-functional siRNA candidate targeting both PCSK9 and APOC3, which could be a powerful therapy for mixed hyperlipidemia.

    One, the first clinical readout of ARO-DIMER-PA, the first dual functional siRNA candidate targeting both PCSK9 and APOC3 for LDL and TG lowering is expected in September.

    Q&A highlights

    5

    What is the timeline and gating factors for the sNDA submission by year-end 2026? What can be expected from the ESC late-breaker data, particularly regarding median vs. mean TG reduction and safety imbalances?

    The sNDA timeline involves a pre-sNDA meeting with the FDA, followed by submission. The team is focused on generating sNDA modules and finalizing data. Details on ESC data are embargoed until the conference, so no specific comments can be made on TG reduction types or safety imbalances.

    “In terms of rate limiters for the sNDA, we do plan to have a pre-sNDA meeting with FDA and then subsequent to our discussions with the agency would file the submission.”

    asked by Maurice Raycroft · answered by James Hamilton

    2 min read5 chapters

    Detailed Narrative

    01

    Plozasiran SHASTA Phase III Results and Regulatory Strategy

    Arrowhead reported positive top-line Phase III results for plozasiran in severe hypertriglyceridemia (sHTG) from the SHASTA-3 and SHASTA-4 studies. Both studies met primary and all secondary endpoints, showing median triglyceride reductions of 79% and 81% respectively. Importantly, plozasiran achieved a 78% reduction in cumulative acute pancreatitis events versus placebo across the broad sHTG population, and a 100% reduction in the highest risk subgroup. The safety profile was favorable with no new signals. The company acquired a Priority Review Voucher for $215 million to accelerate the sNDA submission for sHTG, aiming to shorten the FDA review process from 10 to 6 months, with submission planned before year-end 2026.

    02

    REDEMPLO FCS Launch Progress and International Expansion

    The U.S. launch of REDEMPLO for familial chylomicronemia syndrome (FCS) continues to build momentum, with prescription volume more than doubling quarter-on-quarter. The company has supported over 400 unique prescribers, and payer coverage is progressing rapidly. Internationally, REDEMPLO received approvals in Australia and the European Union, adding to existing approvals in the United States, Canada, and China. The EU label uniquely covers both genetically confirmed and clinically diagnosed FCS patients. Country-specific reimbursement and launch processes are expected over the next 12 months, starting with Germany.

    03

    Cardiometabolic Pipeline Advancements

    Arrowhead is aggressively building its cardiometabolic franchise beyond plozasiran. Interim Phase I/IIa data for ARO-INHBE in obesity and NASH showed compelling results, including a 44% placebo-adjusted reduction in liver fat in a subgroup of obese patients with elevated baseline liver fat. The Phase III YOSEMITE study for Zodasiran in HoFH patients is fully enrolled with 70 patients, exceeding the target of 60. Early data from the ARO-DIMER-PA Phase I study, targeting both APOC3 and PCSK9 for LDL and triglyceride reduction, is expected in September. A new obesity candidate CTA filing is anticipated by year-end.

    04

    CNS Delivery Platform and ARO-MAPT

    The company is advancing its subcutaneous CNS delivery platform, with ARO-MAPT as its first molecule. ARO-MAPT targets the tau protein for tauopathies like Alzheimer's disease. The Phase I clinical trial in healthy volunteers is nearing full enrollment, with top-line data expected in September. This readout is critical as it could provide the first clinical proof of concept for addressing brain targets with RNAi using a simple subcutaneously administered conjugate, validating the platform for numerous additional CNS programs.

    05

    Strategic Partnerships and Financial Strength

    Arrowhead's partnership strategy remains a key model component. A recent exclusive worldwide license agreement with Madrigal for ARO-PNPLA3 included a $25 million upfront payment and eligibility for up to $975 million in milestones and tiered royalties. The company ended the quarter with approximately $1.6 billion in cash and investments, providing significant financial flexibility to support ongoing clinical development, commercialization, and strategic priorities. The company expects to have 23 individual drug candidates in clinical trials by year-end 2026.

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