IOVANCE BIOTHERAPEUTICS, INC. Q4 FY2025 earnings call

• In 2025, delivered substantial revenue growth, achieved data milestones, strengthened financials. Drove Amtagvi adoption, streamlined costs, optimized operations. 30% revenue growth in fourth quarter, 50% margin from cost of sales. Full year revenue ~$264M within guidance. Cash runway extended to Q3 2027. - Plan to execute across 3 core pillars: accelerate U.S. commercial launch of Amtagvi in advanced melanoma; expand TIL pipeline into new indications and next-gen products; hone operational excellence. - Fourth quarter demand for Amtagvi increased, enrollment volumes in 2026 accelerating. TIL platform has expansion potential, lifileucel in nonsquamous non-small cell lung cancer has fast-track designation, positive early data in sarcomas. - Operational excellence improved gross margin, manufacturing success improved, own and control manufacturing for Amtagvi and supply chain.

In 2025, Iovance delivered substantial revenue growth. Fourth quarter had about 30% revenue growth, driven by Amtagvi, with 50% margin from cost of sales. Full year total revenue was about $264 million, well within annual guidance range. Product revenue in fourth quarter was $87 million, up ~30% from prior quarter. Full year product revenue $264 million, up 61% year-over-year, driven by Amtagvi revenue growth of 112% year-over-year. Cash runway extended to third quarter of 2027. Amtagvi's ATC network expanding, Proleukin has potential for U.S. sales at peak. TIL pipeline has expansion potential into new indications.

• Plan to provide revenue guidance with growth projections for 2026 shortly. Cash runway extended to third quarter of 2027. - Laser-focused on maximizing shareholder value, ending dilution, supercharging future profitability. - Will provide more detail on U.S. launch growth when full year revenue guidance for 2026 is introduced.

• Q: On TILVANCE update, possibility of first-line melanoma data with Amtagvi PD-1 combo later this year and ORR/PFS vs PD-1 alone.

A: Early interim read possible, need to see study progress. Benchmark vs pembrolizumab monotherapy data. - Q: Elaborate on big quarter-over-quarter jump in Proleukin revenue and anticipated split of Amtagvi to Proleukin revenue moving forward, and gross margin improvement.

A: Q4 had all 3 distributors ordering, reordering in Q1. No specific split guided, expect further margin improvement. - Q: How manufacturing success rate changed over time and scrap cost.

A: Manufacturing success improving, scrap costs in 10-K filing. Success rates improving through internal manufacturing improvements and commercial/medical affairs work. - Q: Logic for not providing 2026 guidance now and when to expect it, and Proleukin revenue ratio.

A: Need to be sure projections are well supported, will provide shortly. Long-term ratio of Amtagvi to Proleukin revenue stabilizing. - Q: Fourth quarter acceleration breakdown by new community ATCs vs existing academic centers and sarcoma data details.

A: Q4 growth in academic ATCs, community ATCs coming online with learning curve. Sarcoma data to be presented at medical congress, depth and durability ongoing, sample size for registrational study around 40 patients. - Q: Commentary on non-small cell lung cancer study enrollment trends and path to full approval.

A: Fast track designation helpful, planning to launch in 2027. - Q: Consideration of expanding into other sarcoma subtypes.

A: Looking at additional sarcoma subtypes, tapping into unmet medical need. - Q: Proleukin sales uptick breakdown and Proleukin's future.

A: Q4 Proleukin sales driven by Amtagvi demand, will stabilize with Amtagvi demand. - Q: Impact of ex U.S. commercial launches on gross margins.

A: In-house manufacturing, economies of scale will help margins, no added manufacturing expense for ex U.S. launches. - Q: Community ATCs vs academic centers timing and Tandem data use.

A: Community ATCs learning curve similar to academics, MSLs have real-world data on Tandem data to use when talking to physicians