Iovance Biotherapeutics, Inc.

Good day, and thank you for standing by. Welcome to the Iovance Biotherapeutics fourth quarter and full year 2024 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sarah Pellegrino, SVP of Investor Relations and Corporate Communications. Please go ahead.

Thank you, Operator. Good afternoon and welcome to the Iovance conference call and webcast to discuss our fourth quarter and full year 2024 financial results, as well as recent corporate and development program updates. Dr. Fred Vos, our interim chief executive officer and president, will provide an introduction and summarize the latest progress with our U.S. commercial launch of Amitabh V, including revenue and revenue guidance, and a high-level summary of our key pipeline program. Dan Kirby, Chief Commercial Officer, will highlight adoption, market access, and demand at Authorized Treatment Centers, or ATC, community outreach initiatives to drive additional growth for the U.S. commercial launch, as well as our ex-U.S. launch expansion plan for MTAVI and advanced melanoma. Dr. Igor Valensky, our Chief Operating Officer, will cover our commercial manufacturing experience available staff capacity, and the status of our ongoing capacity expansion. John Mark Belleming, our CFO, will review our financial results, including revenue and revenue guidance, gross margin, cash burn guidance, and the strength of our balance sheet. And Dr. Frederick Graf Finckenstein, our chief medical officer, will summarize key pipeline programs, including our two registrational programs in frontline melanoma and advanced non-small cell lung cancer. Additional members of our leadership team, including Dr. Brian Gassman, our Executive Vice President of Medical Affairs, will be available for the question and answer session. Earlier this afternoon, we issued a press release that can be found on our corporate website at iovance.com. Before we start, I would like to remind everyone that statements made during this conference call will include forward-looking statements regarding iovance's goals, business focus, business plans and transactions, revenue and revenue guidance, commercial activities, clinical trials and results, regulatory approvals and interactions, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interaction, licenses and collaboration, cash position and expense guidance, and future updates. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filing. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statements. With that, I will turn the call over to Fred.

Thank you, Sarah. I'm pleased to host this afternoon's conference call to discuss our financial results for the fourth quarter and full year of 2024, as well as our recent corporate highlights. Earlier this month, we marked the one-year anniversary of the historic approval of mTAGV, the first FDA-approved TIL cell therapy and the first treatment for patients with advanced melanoma progressed following anti-PD-1 treatment and, if appropriate, targeted therapy. In 2024, iAdvanced fully transformed into a commercial company. We executed a strong start to the mTAGV U.S. launch, reinvigorated global proleukin sales growth, and gained significant traction in our efforts to launch into new markets. Meanwhile, we advanced our robust pipeline of current and future generation tilt cell therapies across all stages of development to address tens of thousands of patients with solid tumors. Today, I'm pleased to highlight continued growth in total product revenue for both Ampagni and Prolucan. Total product revenue was $73.7 million in the fourth quarter and $164.1 million in the full year of 2024. Importantly, our full year revenue achieved the upper end of our 2024 guidance range of $160 million $165 million, and we finished above the full year street consensus. Total revenue consisted of $48.7 million for Ampagni and $25.0 million for Prolucan in the fourth quarter, with $103.6 million for Ampagni and $60.5 million for Prolucan in the full year period. Our full year product revenue reflects more than 200 patients already treated with Ampagni in the partial first year of launch. We are pleased with the robust initial uptake and increasing strong demand for Amtagni as well as continuing momentum in global Prolucan sales. Our team's successful execution as well as the unmet need, the advanced melanoma, high awareness, broad patient access, and a motivated expanding network of authorized treatment centers, or ATCs, continue to drive increasing demand for Amtagni and Prolucan. Our manufacturing network is well prepared to supply the current and anticipated demand for Amtagni. Today, we have staff capacity to supply more than 1,200 patients per year and continue to scale up for additional U.S. and global launch growth. In the back half of last year, we augmented our investment in focused community referral initiatives. These efforts in the field are targeted at driving additional demand in our ATCs as they scale up to treat more patients. Looking ahead, we are reiterating our full year 2025 guidance of $450 to $475 million in total product revenue. We expect a significant increase in year-over-year growth in both antagony and proleukin as ATCs broaden utilization. While new ATCs, as well as community referral networks, are expected to contribute increasing demand through the year. Our fourth quarter gross margin again improved quarter-over-quarter and is already well over halfway towards our target to surpass 70% over the next several years. And continued increases in revenue and gross margin will also correspond with a significant decrease in our annual cash burn. while maintaining our pipeline of future indications and products. We were judicious in managing our balance sheet 2024 to expect cash burn, including one-time items, to continue to decrease as we execute the launch and drive towards breakeven and profitability. Longer term, we remain confident in significant revenue growth in 2026 and beyond. For the currently approved advanced melanoma indication, the peak sales opportunity is more than $1 billion in the U.S. market alone and more than $2 billion globally. Our XUS launch expansion plans are on track with the potential to gain three new approvals and provide early access to mTAGB in several new markets. iVANCE has distinct competitive advantages with the first approval launch and large-scale manufacturing of TIL cell therapy, combined with strong intellectual property positions and a deep pipeline. Future growth drivers include global label expansions into frontline advanced melanoma, other solid tumor types such as non-small cell lung cancer, and next-generation therapies. As we transition to today's commercial update, I would like to welcome and introduce Dan Kirby on his first quarterly call as a member of the iAdvance team. Dan joined us earlier this month in the newly created role of Chief Commercial Officer. As an instrumental leader in cell therapy commercial organizations since the earliest developments in the field, Dan is the perfect fit for Chief Commercial Officer as we grow the MTagV launch and expand our Perlucan sales. I'm pleased to hand the call to him to discuss our commercial updates.