Iovance Biotherapeutics, Inc. Q2 FY2025 earnings call

Commercial Launch - Adoption of Amtagvi continues with growth in ATCs, and first real-world data shows a nearly 49% response rate among 41 patients. Onboarding large community practices with plans to treat patients from these in the fourth quarter of 2025. - Pipeline - Exciting pipeline with programs to extend the lifileucel franchise, including registrational trials in previously treated advanced non-small cell lung cancer and endometrial cancer, and next-generation PD-1 and activated TIL cell therapy. - Restructuring - Workforce reduction of approximately 19% planned in the third quarter of 2025, generating over $100 million in annual cost savings from the fourth quarter of 2025, aiming to improve gross margins and cash runway. - Manufacturing - The iCTC facility saw improved performance with lower patient drop-offs and out-of-spec rates, and turnaround time shortened to 33 days from receipt of sales to Amtagvi readiness for return shipment.

In the second quarter of 2025, total revenue was $60 million. Product revenue from U.S. Amtagvi sales was approximately $54 million, a 24% quarter-over-quarter growth, with 102 commercial patients treated. Product revenue from Proleukin was approximately $6 million, a 2% quarter-over-quarter increase. Amtagvi contributed about 90% of the total revenue, while Proleukin contributed approximately 10%.

- Reiterated full-year 2025 revenue guidance of $250 million to $300 million, inclusive of Amtagvi sales in the U.S. and Proleukin globally. - Expect Amtagvi U.S. peak sales of $1 billion or more. - Net cash burn expected to be less than $245 million over the next 4 quarters, excluding one-time charges associated with the third quarter strategic restructuring. - Current cash position of approximately $307 million expected to fund operations into the fourth quarter of 2026.

- Forward-looking statements subject to risks outlined in SEC filings, including regulatory, commercial, and manufacturing uncertainties. - Withdrawal of EMA submission due to the need for additional analysis (e.g., virtual control arm), which may impact European commercialization. - Dependence on manufacturing success and regulatory approvals for pipeline programs.

Q: Can you talk about the patient number from 1Q to 2Q and price impact?

A: The number of infusions in Q2 was 102 vs 83 in 1Q. There was a price increase to $562,000 on April 1st, with no impact on demand, and expecting strong demand in the second half.

Q: Confidence in Proleukin acceleration?

A: Reordering from wholesalers, expecting pickup in Proleukin revenue as Amtagvi demand drives usage.

Q: Margin improvement expectation?

A: Restructuring and operational excellence initiatives expected to improve margins, with cost of sales optimization and volume ramp.

Q: EMA withdrawal reason and Europe commercialization?

A: Withdrawal due to the need for additional analysis like a virtual control arm, planning to resubmit with EMA scientific advice.

Q: Infusions tracking and ATC metrics?

A: Strong demand but no QTD infusion details, ATCs have seen growth but focus on quality of ATCs with referral patterns in place.

Q: EMA impact on NSCLC?

A: No impact on U.S. NSCLC trials.

Q: Patient drop-offs and specialty pharmacy?

A: Patient drop-offs improved, specialty pharmacy helps reach healthier patients upstream, potential long-term revenue impact.

Q: Clinical trial patient enrollment?

A: Data to be shared by end of year, no pre-defined patient number for updates.

Q: Patient ramp and ATC activation?

A: Confident in tracking to revenue guidance, focusing on quality of ATCs with referral patterns in place.