Iovance Biotherapeutics (IOVA) investor relations material

Executive summary

• Third quarter revenue increased 13% sequentially to approximately $68 million, driven by increased Amtagvi demand and expanded treatment center network.

• Gross margin improved to 43% due to restructuring, operational efficiency, and cost optimization initiatives.

• Amtagvi launch progressing with over 80 U.S. authorized treatment centers and strong adoption in both academic and community settings.

• Cash position was approximately $307 million as of September 30, expected to fund operations into Q2 2027.

• Real-world data show a 60% response rate for Amtagvi in second-line melanoma, reinforcing its clinical value.

Financial highlights

• Product revenue for Q3 was approximately $68 million, up 13% from the prior quarter; nine-month revenue reached $176.7 million, up from $90.4 million year-over-year.

• Amtagvi sales were about $58 million; Proleukin contributed nearly $10 million in revenue.

• Gross margin increased to 43% on cost of sales of $39 million, driven by a 21% reduction in cost of sales and a 10% reduction in total costs and expenses, excluding $5 million in restructuring charges.

• Net loss for Q3 2025 was $91.3 million, compared to $83.5 million in Q3 2024.

• Cash, cash equivalents, and investments totaled $300.8 million at quarter end.

Outlook and guidance

• Revenue guidance for full-year 2025 is reaffirmed at $250–300 million, with strong Q4 expected.

• Amtagvi peak US sales projected to exceed $1 billion in melanoma, with larger opportunities in international markets and future indications.

• Lifileucel in NSCLC expected to complete enrollment in 2026 and potentially launch in H2 2027.

• Centralized manufacturing at iCTC in early 2026 expected to further reduce costs and improve margins.

• Global expansion is underway, with Canada approved and pending approvals in the UK, Australia, and Switzerland; meaningful international revenue expected from 2027 onward.