IOVANCE BIOTHERAPEUTICS, INC. Q4 FY2024 earnings call

• Historic approval of Amtagvi, the first FDA-approved TIL cell therapy for advanced melanoma, marked one year earlier this month.
• 2024 was a year of transformation into a commercial company, with strong start to Amtagvi's U.S. launch, growth in Proleukin sales, and progress in global launch of Amtagvi for advanced melanoma.
• Manufacturing network has staffed capacity to supply over 1,200 patients annually and is scaling up. Community referral initiatives were augmented in the back half of 2024 to drive demand.
• Ex-U.S. launch expansion plans for Amtagvi in advanced melanoma are on track, with three regulatory dossiers under review for potential approvals in 2025.
• Fourth quarter gross margin improved quarter-over-quarter, moving towards surpassing 70% in the next several years. Cash burn is expected to decrease while maintaining pipeline.

In the fourth quarter of 2024, total product revenue was $73.7 million, with Amtagvi contributing $48.7 million and Proleukin contributing $25.0 million. For the full year 2024, total product revenue was $164.1 million, with Amtagvi at $103.6 million and Proleukin at $60.5 million. The full year 2024 revenue achieved the upper end of the guidance range of $160 million to $165 million. Amtagvi's revenue in Q4 2024 was 48.7 million, contributing ~66.1% to Q4 total product revenue, and Proleukin was 25.0 million, contributing ~33.9%. For full year 2024, Amtagvi contributed ~63.1% and Proleukin ~36.9% to total product revenue.

• Reiterated 2025 total product revenue guidance of $450 million to $475 million, expecting significant year-over-year growth in Amtagvi and Proleukin as ATCs broaden utilization.
• Anticipated cash burn for 2025 to be less than $300 million, including investment in ICTC facility expansion, with cash burn expected to decrease as revenue grows and gross margin improves.
• Peak sales opportunity for advanced melanoma indication is over $1 billion in the U.S. and over $2 billion globally.

• Forward-looking statements subject to numerous risks and uncertainties, including those described in SEC filings, which could cause results to differ materially from projections.

Q: Andrea Newkirk with Goldman Sachs asked about patient infusions in Q4 and confidence in 2025 guidance.

A: Fred Vogt said they're not providing infusion numbers now but see potential growth in ATCs with 70 ATCs and 13% having infused over 10 patients, maintaining confidence in 2025 guidance.

Q: Peter Lawson with Barclays asked about IL-2 revenues and future demand.

A: Fred Vogt said IL-2 revenue is a leading indicator for Amtagvi sales, with strong uptake by distributors and expecting it to be a significant portion of 2025 revenue.

Q: Ben Burnett with Stifel asked about physicians' views on new entrants.

A: Fred Vogt said the potential entrant's clinical data isn't comparable, with their patient population being earlier, and Amtagvi has a premier product.

Q: Colleen Kusy with Baird asked about seasonality in Q4.

A: Fred Vogt said no seasonality observed, mentioning manufacturing maintenance periods similar to other cell therapy products.

Q: Tyler Van Buren with TD Cowen asked about price increase in guidance and ex-U.S. expansion impact.

A: Fred Vogt said the April price increase is factored into 2025 guidance, and current guidance doesn't include ex-U.S. contribution.

Q: Yanan Zhu with Wells Fargo Securities asked about Q4 infusions and growth.

A: Fred Vogt said there were ~95 revenue infusions in Q4, with strong quarter-over-quarter growth and expectation of continued growth.

Q: Asthika Goonewardene with Truist asked about proportion of ATCs at steady state.

A: Fred Vogt said a low proportion, with Dan Kirby adding ATCs are inching towards 10-plus infusions and leading in referrals.

Q: Reni Benjamin with Citizens JMP asked about pipeline data and registrational plans.

A: Friedrich Graf Finckenstein said data from LUN-202 and endometrial trials will be shared in 2025, with timing of registrational decisions in 2027 for non-small cell lung cancer.

Q: Salim Syed's colleague asked about registrational Phase 2 trial in non-small cell lung cancer bogey.

A: Fred Vogt and Friedrich Graf Finckenstein said FDA allows single-arm trial, comparing to standard-of-care with low response rates and short durability, and TIL therapy has longer durability and mid-20% response rates.

Q: David Dai with UBS asked about holiday spillover impact on resections.

A: Fred Vogt and Dan Kirby said no seasonality observed, with ATCs running through holidays without interruption.

Q: Andrew Tsai with Jefferies asked about bottlenecks in launch uptake.

A: Fred Vogt and Dan Kirby said ATCs have a learning curve, with some having staffing or financial challenges, but progress being made as ATCs scale and referrals increase