IOVANCE BIOTHERAPEUTICS, INC. Q3 FY2024 earnings call

• U.S. commercial launch of Amtagvi for advanced melanoma is proceeding well with robust demand. Third quarter Amtagvi revenue was $41 million, surpassing guidance. - ATC network is scaling with 56 ATCs in the US, aiming for 70 by year-end. Community referral initiatives are driving demand. - Manufacturing of Amtagvi is ramping up with two FDA-approved facilities, and capacity is being expanded. Turnaround time for manufacturing and release testing is 34 days. - Financial results show third quarter net loss of $83.5 million, but revenue exceeded guidance. Gross margin is moving towards the target of over 70%. - Clinical pipeline includes progress in lung, melanoma, endometrial cancers, and next-generation TIL cell therapies. For example, Cohort 3A in lung cancer shows promising response rates.

In the third quarter of 2024, total product revenue was $58.6 million. Amtagvi contributed $41 million, which was 70% of the total product revenue for the quarter. Proleukin contributed $16.5 million, making up 28% of the total. Year-to-date, Amtagvi generated $54.9 million (60.7% of $90.4 million total year-to-date revenue) and Proleukin contributed $35.5 million (39.3% of the year-to-date total).

• Reaffirmed full-year 2024 total product revenue guidance of $160 million to $165 million. - Reiterated full-year 2025 total product revenue guidance of $450 million to $475 million. - Full-year 2024 cash burn guidance is in the range of $320 million to $340 million excluding one-time expenses. - Expect significant year-over-year growth in 2025 and beyond as ATCs expand and new markets are pursued.

Q: Tyler Van Buren from TD Cowen asked about the potential impact of holidays on Q4 infusions and if there were infusions scheduled around holidays.

A: Friedrich Graf Finckenstein responded that there is a bit of a lull during holidays but the company has accounted for it in projections and expects to perform well in Q4.

Q: Peter Lawson from Barclays inquired about IL-2 stocking level and how it changes over time.

A: Fred Vogt replied that they are stocking up three specialty distributors, numbers will be steady with potential slight fluctuations, and after stocking major distributors, growth will start in 2025.

Q: Andrea Newkirk from Goldman Sachs asked about preconditioning happening in parallel with Amtagvi arrival and if ATCs are confident.

A: Fred Vogt said ATCs are more confident, especially larger and more sophisticated ones, and this confidence will lead to more preconditioning in parallel.

Q: Yanan Zhu from Wells Fargo asked about Q3 infusion distribution, month-to-month growth trajectory, and drivers.

A: Fred Vogt stated there was month-over-month growth in Q3 infusions, driven by ATC growth, manufacturing capacity, and improved out-of-spec rates.

Q: Ben Burnett from Stifel asked about profitability and gross margin goals.

A: Fred Vogt and Jean-Marc Bellemin responded that gross margin is moving towards over 70% due to capacity utilization, operational excellence, and cost optimization in manufacturing.

Q: David Dai from UBS asked about dropout rate improvement.

A: Fred Vogt said they are optimizing the launch, teaching ATCs better patient throughputs and resection quality, and dropout rate is expected to improve quarter over quarter.

Q: Michael Yee from Jefferies asked about reimbursement and lung cancer pivotal study.

A: Fred Vogt responded that reimbursement financial clearance time is down to 3 weeks, and for lung cancer, data is expected in 2025 with potential approval in 2027.

Q: Asthika Goonewardene from Truist Securities asked about trends influencing OS and factors in outer spec rate.

A: Fred Vogt said it's a combination of centers gaining experience and new centers benefiting from early learning and peer-to-peer support.