Strong revenue growth and improved margins
Q4 product revenue of $87M, ~30% growth quarter-over-quarter; full-year 2025 product revenue of ~$264M, up 61% year-over-year; Amtagvi revenue grew 112% YoY. Fourth-quarter gross margin from cost of sales improved to 50% (from 43% in Q3). Gross-to-net adjustments remained minimal at <2% for 2025.
Solid balance sheet and extended runway
Year-end cash position of approximately $303M. Management reports cash runway extended into Q3 2027 due to cost savings and operational discipline.
Accelerating commercial adoption of Amtagvi and large market opportunity
Amtagvi adoption accelerating across academic and community Authorized Treatment Centers (ATCs); management cites potential >30,000 previously treated advanced melanoma patients annually. Company projects Amtagvi + Proleukin could reach $1B+ U.S. sales at peak in melanoma, with non-squamous NSCLC opportunity ~7x larger (~50,000 addressable patients) and a stated U.S. NSCLC peak sales opportunity of up to $10B.
Manufacturing internalization and operational improvements
All lifileucel manufacturing transitioned to the U.S.-based Iovance Cell-Therapy Center (ICTC). Company reported highest manufacturing volume and highest commercial manufacturing success to date, reduced dropouts, modular ICTC capability to provide uninterrupted supply, and improved capacity utilization to reduce cost of sales.
Regulatory progress and clinical data for lifileucel (NSCLC)
Lifileucel in previously treated non-squamous NSCLC: objective response rate (ORR) 26%, disease control rate (DCR) 72%, median duration of response not reached after >25 months of follow-up. FDA granted fast-track designation for this indication; company is advancing toward a supplemental BLA with potential accelerated approval and launch in H2 2027.
Promising early sarcoma data
Pilot study in previously treated advanced undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma: 50% confirmed objective response rate among 6 evaluable patients. Company plans a single-arm registrational trial and sees sarcoma populations (UPS + DDLPS) as meaningful incremental market opportunity (company cites >8,000 patients in U.S. and Europe annually across sarcoma subtypes).
Commercial support products contributing to revenue
Proleukin is contributing meaningfully to revenue (management cites ~17% contribution for full year 2025). All three wholesalers reordered in Q4 and reorders continued into Q1; company implemented a ~9% price increase effective Feb 1.