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    IOVA
    Earnings call· Jun 2026(Q2 FY26)

    IOVANCE BIOTHERAPEUTICS Q2 FY26 earnings call IOVA

    Aug 6, 2026 Source

    Executive summary

    Iovance Biotherapeutics Q2 FY26 — Record Revenue and Margin, Pipeline Advancement

    Iovance Biotherapeutics delivered a robust second quarter, driven by record revenue and expanding gross margins, primarily from strong Ampagni demand. The company is advancing its clinical pipeline with key regulatory designations and trial progress, while also managing operating expenses effectively. Management is reviewing its full-year revenue guidance, anticipating an upward revision in the third quarter, reflecting confidence in continued commercial momentum and operational discipline.

    Highlights

    5

    • Record total revenue of $99.3 million, up 66% year-over-year and 39% sequentially.

    • Ampagni revenue reached a new high of approximately $91 million, exceeding guidance.

    • Gross margin increased to an all-time high of 56%, up from 41% in Q1 FY26.

    • R&D expenses decreased for the fourth consecutive quarter to $59 million, reflecting efficiency gains.

    • FDA granted Fast Track designation for SAR201 in two advanced soft tissue sarcomas.

    Concerns

    2

    • Perlucan revenue slightly down to $9 million from $11 million in the prior quarter due to wholesaler inventory timing.

    • Full-year 2026 total revenue guidance of $350-$370 million is under review, with an update planned for Q3.

    Guidance & targets

    7
    CategoryTargetConfidence
    Full-year 2026 Total Revenue
    $350M-$370M
    high materiality
    Medium
    Perlucan as % of Total Revenue
    in line with 2025
    medium materiality
    High
    Perlucan as % of Total Revenue (rest of year)
    approximately 16%
    medium materiality
    High
    Cash Runway
    into the second half of 2028
    high materiality
    High
    Authorized Treatment Centers (ATCs)
    at least 110
    medium materiality
    High
    Lung 202 sBLA Submission
    supplemental biologic splicense application
    high materiality
    High
    IOB5001 (G1-TIL-1) Program Updates
    more updates
    low materiality
    High

    Segment performance

    3
    SegmentRevenueYoYQoQMargin
    Ampagni
    Ampagni sales reached a new high, driven by increased physician awareness, ATC network expansion, and deepening clinical evidence, including real-world data showing >50% response rates in patients with two or fewer lines of therapy.
    Exceeded Q2 guidance range of $79M-$81MKey growth driverCommercial momentum carrying into Q3
    		$91M68%51%—
    Perlucan
    Perlucan sales were slightly impacted by wholesaler inventory timing but demand remains strong, with wholesalers now ordering in line with Ampagni demand. It is a high-margin product.
    Slightly down from prior quarter due to timing of wholesaler inventory stockingExpected to be ~16% of total revenue for rest of yearExpected to be in line with 2025 as a percentage of total revenue for FY26
    		$9M—down from $11M—
    International (Ampagni)
    Iovance is expanding Ampagni into new international markets, with initial ATCs opening for private pay patients while working towards public reimbursement. Australia has the highest rate of melanoma globally.
    Approved in CanadaApproved in AustraliaRegulatory approvals pending in UK and SwitzerlandWorking towards resubmission in EU
    		————

    Operational metrics

    16
    Total Revenue Growth
    66%YoY
    Q2 FY26

    Driven by record Ampagni demand.

    Gross-to-Net Impact
    <1%
    Q2 FY26

    Remains minimal, consistent with prior quarters.

    Gross Margin
    56%up from 41% in Q1 FY26
    Q2 FY26

    Reached an all-time high, with expectations for continued expansion.

    R&D Expenses
    $59Mdown from $62M in Q1 FY26
    Q2 FY26

    Reflecting ongoing efficiency gains as all programs progress.

    SG&A Expenses
    $39Messentially flat
    Q2 FY26

    Held flat even as revenue grew roughly 39%, demonstrating operating leverage.

    Cash and Investments Balance
    $304M
    as of June 30, 2026

    Well capitalized to fund launch and pipeline, expected to fund operations into H2 2028.

    Total ATCs
    >95
    current

    Expanding network, with more activating, enrolling, and infusing patients.

    Community ATCs as % of Total
    1/3
    current

    Widening commercial reach, with patients residing earlier in their treatment journey.

    Ampagni Turnaround Time
    31 days or less
    current

    Proving ability to deliver on promise to patients using scaled centralized commercial manufacturing.

    Ampagni Payer Coverage (Private)
    >75%
    current

    Strong payer coverage with Ampagni added to policies.

    Patient Proximity to ATCs
    >95%
    current

    US ATCs strategically located to address most patients.

    Patients Treated with TIL Therapies
    Nearly 2,000
    cumulative

    In commercial and clinical settings across hundreds of centers.

    Future Patient Reach Vision
    tens of thousands
    coming years

    Vision for the coming years.

    Ampagni 10-year Overall Survival (Responders)
    46.7%
    10-year

    Estimated from new survival analysis from clinical trial, presented at ASCO.

    Ampagni Real-World Response Rate
    >50%
    current

    Published manuscript data, convincing physicians to adopt Ampagni earlier.

    Ampagni Commercial Patients Treated
    >50
    monthly

    Demonstrates manufacturing scale and accessibility, on top of increasing clinical patients.

    Industry KPIs

    10
    MetricValueDetails
    Launch access metrics—
    Pipeline read out calendar—
    Product franchise net sales$91MUSD
    Regulatory approvals filings—
    Peak long term sales guidance>$1BUSD
    Therapeutic drug market share—
    Prescription volume new starts—
    Clinical trial efficacy safety data—
    Collaboration milestone royalty revenue—
    Cumulative patients uptake since launchNearly 2,000patients

    Risks & headwinds

    2
    Wholesaler inventory timing for PerlucanQ2 FY26

    Perlucan revenue slightly down from $11 million to $9 million in Q2 FY26

    Mitigation: Wholesalers have sold through previous stocking inventory and are now ordering in line with Ampagni demand.

    Competitive landscape for TIL therapiesNear to medium term

    RepliMune's agent potentially entering the market; Obsidian going public as a TIL competitor.

    Mitigation: Iovance views RepliMune as competitive with TVEC, not Ampagni, due to Ampagni's superior profile and real-world experience. Iovance highlights its significant lead, infrastructure, and experience over other TIL competitors like Obsidian.

    What to watch in Q3 FY26

    5

    Full-year 2026 Total Revenue Guidance Update

    Q3 FY26
    Current$350M-$370M (under review)
    TargetRevised guidance (expected higher)

    Why it matters

    A revised guidance will reflect management's updated confidence in commercial momentum and operational performance for the full year.

    Once we fully assess increasing growth trends, we expect to provide an update to our full year guidance during the third quarter.

    Q&A highlights

    5

    Was Q2 revenue purely organic demand or timing? Clarify Lung 202 data release: complete enrollment then follow-up on all, or majority?

    Q2 demand was organic, driven by increased awareness, ATC expansion, and clinical data. Lung 202 will complete enrollment before material update, but not necessarily wait for every patient's full follow-up.

    “Just to add to Dan, just to be very clear, Andrew, there's not a timing issue or anything. This is organic demand for the product. It's looking very good right now based on all the factors that Dan described and more that we really do expect that demand is going to continue to increase significantly for Ampagby throughout the coming quarters.”

    asked by Andrew Sy · answered by Frederick Vogt

    2 min read5 chapters

    Detailed Narrative

    01

    Commercial Momentum and Market Expansion

    Iovance reported record Q2 FY26 revenue and margin, driven by strong demand for Ampagni. The company is expanding its Authorized Treatment Center (ATC) network, with community ATCs now representing one-third of the network and expected to grow significantly. This expansion, coupled with increasing physician awareness and deepening clinical evidence, is broadening access and driving earlier adoption of Ampagni.

    02

    Pipeline Advancement in Solid Tumors

    The company is making significant progress across its clinical pipeline. Enrollment is nearly complete in the pivotal cohorts of the Lung 202 trial for non-squamous non-small cell lung cancer, with an sBLA targeted for 2027. The Saratoga trial for SAR201 in soft tissue sarcomas received Fast Track designation from the FDA, following promising pilot study data showing a 50% objective response rate.

    03

    Next-Generation TIL Therapies and Biomarker Strategy

    Iovance is investing in next-generation programs, including the G1-TIL-1 trial using IOB5001, an IL-12 tethered TIL therapy, targeting prevalent solid tumors. The company is also leveraging a histology-based biomarker strategy, which produced striking early Phase 2 data in metastatic serous endometrial cancer (N201 trial) with a 40% confirmed objective response rate, leading to engagement with the FDA for an expedited approval pathway.

    04

    Operational Efficiency and Financial Discipline

    The company demonstrated strong operational leverage, with gross margin reaching an all-time high of 56% due to higher volume, cost optimization, and maturing internal manufacturing efficiencies. Research and development expenses decreased for the fourth consecutive quarter, while selling, general, and administrative expenses remained flat, contributing to a cash runway extending into the second half of 2028.

    05

    International Expansion and Regulatory Progress

    Iovance continues to expand its global footprint, having secured approvals for Ampagni in Canada and Australia. Regulatory approvals are pending in the United Kingdom and Switzerland, and the company is working towards resubmission in the European Union, aiming to serve a globally addressable patient population of over 30,000 annually for previously treated melanoma.

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