Iovance Biotherapeutics, Inc. (IOVA) Earnings

Management highlights

### Commercial Launch and Access Highlights - The company delivered record Q2 2026 revenue and margin, with commercial launch momentum carrying into Q3 2026, with more patients treated than in any prior quarter. - Three core commercial priorities to drive Ampagni growth: rising physician awareness, expanded authorized treatment center (ATC) network, and deepening clinical evidence. Unaided physician awareness has increased nearly threefold over the past 12 months, driven by a new ASCO marketing campaign and improved sales force effectiveness. - As of Q2 2026, the company has over 95 total ATCs, on track to reach at least 110 by end-2026. Community ATCs now represent 33% of the total network, with this share expected to increase significantly over coming quarters. Over 95% of addressable U.S. patients live within 200 miles of an ATC, and 80% live within 100 miles. - Ampagni has strong payer coverage, with payers covering over 250 million U.S. lives including the product in their formularies, and over 75% of private payer patients have coverage. The company maintains a 31-day or shorter turnaround time for manufacturing, the only scaled centralized commercial TIL therapy process approved by the FDA. - Internationally, Ampagni has received approvals in Canada and Australia, with the first ATCs activated for private pay patients while public reimbursement/government pricing is finalized. Regulatory approvals are pending in the UK and Switzerland, and the company is working toward resubmission in the European Union. ### Pipeline and Clinical Progress Highlights - Enrollment is nearly complete in the Lung 202 registrational trial for non-squamous non-small cell lung cancer, an indication with a market size ~7x larger than advanced melanoma. Top-line program updates are expected in Q4 2026, with a supplemental biologics license application (BLA) targeted for 2027. - The FDA granted Fast Track designation to lifelucel for undifferentiated pleomorphic sarcoma and de-differentiated liposarcoma in the Saratoga registrational trial. Preliminary pilot data shows a 50% objective response rate, compared to less than 5% with current standard of care. - A new Phase 1-2 trial (G1-Tilt-1) for next-generation IL-12 tethered TIL therapy IOB5001 is ongoing across multiple high-mortality solid tumor indications, including metastatic colorectal, triple negative breast, and estrogen-receptor low breast cancers. Additional updates are expected in 2026. - The TILVAN 301 trial for frontline Ampagni plus pembrolizumab is enrolling as planned. Updated compelling clinical data from the predecessor Phase 2 study will be presented at ESMO, including ~33% complete response rate and rapid response velocity. - Nearly 2,000 patients have received Iovance TIL therapies across commercial and clinical settings, across hundreds of centers in the U.S. and 30 countries. The company's long-term vision is to reach tens of thousands of patients annually. ### Financial and Operational Highlights - This was the first full quarter of exclusively in-house manufacturing, with cost optimization and maturing internal efficiencies driving margin expansion. The company is deploying AI tools to drive further future cost savings and pipeline insights. - As of June 30, 2026, the company held $304 million in cash, cash equivalents, and short-term investments, which is expected to fund operations into the second half of 2028.

Guidance

- The company exceeded its Q2 2026 Ampagni and total revenue guidance ranges, and is currently reviewing its previously issued full-year 2026 total revenue guidance of $350 to $370 million. An updated full-year guidance will be announced sometime in Q3 2026. - Management expects demand growth to continue, with Q3 2026 revenue set to build on the strong Q2 2026 results, followed by further growth in Q4 2026. The company expects gross margin to continue expanding as revenue grows, execution improves, and scale drives additional efficiency gains. - The company expects to update its four-year long-term guidance during Q3 2026 after fully assessing ongoing growth trends. Management maintains its long-term peak sales assumption of over $1 billion in U.S. sales for Ampagni and Prolucan from advanced melanoma alone, with far larger opportunity in other indications. - Prolucan sales are expected to grow quarter-over-quarter for the remainder of 2026, in line with Ampagni growth, stabilizing at ~16% of total annual revenue as projected.

Segment performance

Iovance Biotherapeutics reported total Q2 2026 revenue of $99.3 million, an increase of 66% year-over-year (YoY) and 39% sequentially from Q1 2026. The Ampagni segment was the primary growth driver, generating $91 million in Q2 revenue, which accounts for approximately 91.6% of total Q2 revenue. Ampagni revenue increased 51% sequentially from Q1 2026 and 68% YoY, beating the company's previous guidance range of $79 to $81 million. The Prolucan segment contributed approximately $9 million in Q2 revenue, equal to around 9.1% of total Q2 revenue, down slightly from $11 million in Q1 2026 due to timing of wholesaler inventory stocking. For full-year 2026, management expects Prolucan to represent approximately 16% of total annual revenue, consistent with its 2025 revenue contribution share. Overall gross margin reached an all-time high of 56% in Q2 2026, up from 41% in Q1 2026 and 50% in Q4 2025, with a year-to-date 2026 gross margin of 50%. Research and development (R&D) expenses were $59 million in Q2 2026, down from $62 million in Q1 2026, marking the fourth consecutive quarter of declining R&D expenses driven by efficiency optimization. Selling, general and administrative (SG&A) expenses remained flat at approximately $39 million in Q2 2026, even as total revenue grew 39% quarter-over-quarter.

Risks & headwinds

- All forward-looking statements, including pipeline progress, revenue projections, regulatory approval timelines, and clinical trial results, are subject to inherent risks and uncertainties that could cause actual results to differ materially from projections. These include risks related to clinical trial execution, regulatory review and approval, payer reimbursement, manufacturing supply, and commercial adoption, many of which are outside the company's control. - New community ATCs require a multi-month learning curve after activation before they reach full patient treatment capacity, which could near-term slow revenue growth from network expansion. Competitor products entering the TIL and oncology solid tumor space could create commercial pressure, though management views Ampagni's efficacy and real-world data as a strong competitive advantage.

Analyst Q&A

• Q: What drove the larger-than-expected Q2 revenue upside, was it organic demand or one-off timing factors? Also, what is the timeline and requirements for the Lung 202 top-line data release? /

  A: The Q2 revenue upside was entirely driven by organic demand, with no one-off timing or shipment impacts. Demand growth stems from rising physician awareness, expanding ATC access, and newly published real-world evidence showing over 50% response rate in early-line patients, which has accelerated adoption. For Lung 202, enrollment will be completed before any data update is released, but the company will not wait for all enrolled patients to complete follow-up to release top-line data, as long as all patients are enrolled to maintain trial data integrity. Early trends for the trial are very positive.

• Q: Is it correct that management expects continued demand growth in Q3 and Q4 2026, will guidance be updated in Q3, and what can we expect from the upcoming ESMO presentation for TILVAN 301? /

  A: Yes, demand trends are very positive, and the company expects increasing demand in both Q3 and Q4 2026, with current Q3 visibility already confirming this momentum. Updated guidance will be released as a separate announcement sometime in Q3 2026, after the company fully assesses full-year demand trends. At ESMO, management will present data from the TILVAN 301 predecessor Phase 2 study, showing that ~33% of frontline patients achieve complete response with rapid response velocity, addressing unmet need for alternative frontline regimens for melanoma. The randomized TILVAN 301 trial remains blinded, with an interim readout planned as soon as feasible.

• Q: What are the remaining opportunities for further gross margin expansion after the large Q2 step-up? /

  A: Margin growth in Q2 was driven by higher volume, full in-house manufacturing efficiencies, and ongoing operational process optimization. Further margin improvement will come from continued volume scaling, additional process automation and AI-enabled efficiency improvements, and a growing contribution from high-margin Prolucan, which will stabilize as a share of total revenue and provide an ongoing margin tailwind.

• Q: How is demand distributed across mature, new, and community ATCs, and how do community ATCs differ from academic centers? /

  A: Growth is broad across all ATC segments: original 2024-opened ATCs continue to grow, 2025-onboarded ATCs are hitting full stride, and 2026-opened ATCs are already contributing new patient volumes after a short activation learning curve. Community ATCs, which now make up one-third of the network, access earlier-line patients that generally stay in the community setting rather than being referred to academic centers. Community ATCs have a higher long-term volume ceiling due to organic in-network referral patterns, but require a short ramp-up period to reach full operating capacity.