IOVANCE BIOTHERAPEUTICS, INC. Q1 FY2025 earnings call

Amtagvi U.S. Launch

• First 12 months of U.S. launch generated over $210M in revenue. Q1 2025 product revenue was $49.3M. Factors affecting Q1 revenue: ICTC annual maintenance reducing manufacturing capacity, lower Proleukin sales, and variable ATC patient treatment pace.

Commercial Update by Dan Kirby

• Observed strong commercial organization, 70 ATCs in treatment network, early inclusion in NCCN guidelines, and favorable reimbursement. Focus areas: ATC network expansion/retention, revamping medical oncologist engagements, and establishing Amtagvi in community oncology networks.

Manufacturing Update by Igor Bilinsky

• ICTC completed annual maintenance, manufacturing capacity reduced by over 50% in Dec 2024, but rebounded in Q2. Manufacturing success rate improved post-Q1. IP and manufacturing in U.S. provide strategic advantage, minimal tariff impact.

Financials by Jean-Marc Bellemin

• Cash position $366M as of March 31, 2025. Net loss Q1 2025 $116.2M. Cost of sales $49.7M in Q1 2025, with impact from patient drop-off and manufacturing issues. Gross margin expected to exceed 70% in future.

Clinical Pipeline by Friedrich Finckenstein

• Five-year results from C-144-01 trial to be presented at ASCO. Pipeline includes frontline melanoma, non-small cell lung cancer, endometrial cancer trials, and next-gen TIL therapies.

Total product revenue for the first quarter of 2025 was $49.3 million. This included $43.6 million from Amtagvi infusions (contributing 88.4% to total product revenue) and $5.7 million from Proleukin sales (contributing 11.6% to total product revenue). In the first 12 months of the U.S. launch of Amtagvi, over $210 million in revenue was generated.

• Revised full-year 2025 product revenue guidance to $250M-$300M.
• Maintained cash runway guidance into second half of 2026.
• Projected 100-110 commercial patient infusions in Q2 2025.
• Anticipate global approvals for Amtagvi in UK, Canada, EU, and regulatory submissions in Australia, Switzerland.

• Patient drop-off and lower manufacturing success rates in Q1, though rebounded in Q2.
• Uncertainties related to ATC adoption, manufacturing maintenance impact, and geopolitical/tariff factors.

Q: Line of sight for Q2 guidance?

A: Dan Kirby confirmed strong demand in Q2, confident in 110 patient infusion guidance.

Q: ATCs with over 10 infusions and barriers for others?

A: Fred Vogt and Dan Kirby discussed some ATCs were in trials, others ramping up with infrastructure needs.

Q: Guidance implication on infusions and Proleukin?

A: Fred Vogt and Dan Kirby explained guidance implies growth, with over 500 infusions expected in 2025, and Proleukin sales resuming.

Q: COGS and patient attrition?

A: Jean-Marc Bellemin and Igor Bilinsky discussed COGS increase due to patient drop-off and manufacturing issues, improving in Q2.

Q: Manufacturing maintenance impact?

A: Fred Vogt and Igor Bilinsky said maintenance impact was transient, improving in Q2, and future maintenance will have less impact with ICTC build-out.

Q: Strategies for ATC manufacturing and guidance revision?

A: Brian Gastman discussed field teams helping ATCs with surgical and procurement best practices; Fred Vogt explained guidance revision based on ATC launch dynamics.

Q: Manufacturing split and tissue needs?

A: Fred Vogt said ICTC handles most manufacturing; Brian Gastman discussed guidance on tumor tissue procurement for better success rates.