Iovance Biotherapeutics, Inc.

Thank you for standing by. My name's Wandeep and I'll be your operator today. I'd like to welcome everyone to the iAvant third quarter 2024 financial results call. I would now like to turn the call over to Sarah

Thank you, Operator. Good afternoon, and thank you for joining this conference call and webcast to discuss our third quarter and year-to-date 2024 financial results, as well as recent corporate and development program updates. Dr. Fred Vogt, our Interim Chief Executive Officer and President, will provide an introduction and summarize the latest progress with our U.S. commercial launch of Amtagvi, including revenue and revenue guidance, patient demand and market access, an update on our global regulatory submission, and a high-level summary of our key pipelines. Dr. Brian Gassman, our Executive Vice President, Medical Affairs, will highlight adoption and demand at Authorized Treatment Centers, or ATCs, as well as our community outreach initiatives to drive additional growth for the U.S. commercial launch of AMTAG-V in advanced melanoma. Dr. Igor Belinsky, our Chief Operating Officer, will cover our commercial manufacturing experience and the status of our ongoing capacity expansion. John Mark Bellamin, our Chief Financial Officer, will review our financial results, including revenue and revenue guidance, gross margin, and the strength of our balance sheet. And Dr. Frederick Graf Finkenstein, our Chief Medical Officer, will review key pipeline highlights including recent updates related to our clinical program in frontline non-small cell lung cancer. Dr. Raj Puri, our EVP of Regulatory Affairs, and Anne Brooks, Senior Vice President Commercials, are also on the call and available for the Q&A session. Earlier this afternoon, we issued a press release that can be found on our corporate website at iobance.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 interactions, licenses and collaborations, 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 FTC 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 introduction, I will hand the call to Fred.

Thank you, Sarah. I am pleased to host this afternoon's conference call to discuss our financial results for the third quarter and year-to-date of 2024, as well as our recent corporate highlights. IVANS is nearing the end of a successful year following our first FDA approval and a strong start to the U.S. commercial launch of Ampagme for patients with advanced melanoma. We are rapidly advancing our robust pipeline of current and future generation TIL cell therapies across all stages of development to expand our commercial opportunities. I would like to begin by highlighting the exceptional continued demand for MTagV. Our third quarter total product revenue was $58.6 million, surpassing the top end of our third quarter total product revenue guidance of $53 to $55 million. Total product revenue in the third quarter included $41 million for Ampagmi and $16.5 million for Prolucan. As a reminder, Ampagmi revenue is recognized upon infusion to the patient. Prolucan revenue is recognized upon delivery to distributors or hospitals, typically a few months prior to Ampagmi infusion. Year-to-date total product revenue was $90.4 million through September 30th, including $54.9 million for Ampagmi, and $35.5 million for Prolucan. Third quarter and year-to-date revenue reflects robust initial uptake and increasing strong demand and adoption of Ampagme, as well as sales of Prolucan used with Ampagme. Since the first infusion in April through today, 146 patients have been infused with Ampagme, keeping us on track towards our 2024 guidance and representing about $75 million 2024 revenue from Ampagme alone, with more to come. Infusions over time also reflect an increasing rate of adoption, with 25 in the second quarter, 82 in the third quarter, and 39 in the fourth quarter to date. Our team's successful execution, as well as the unmet medical need in advanced melanoma, high awareness, broad patient access, and a motivated and expanding network of authorized treatment centers, or ATCs, continue to drive strong adoption and uptake of Ampagli and Prolutkin. With 56 current ATCs, we remain focused on our goal of onboarding approximately 70 total ATCs by year end. Our community referral initiatives are also driving additional demand as our ATCs continue to scale up to treat more patients. In addition to robust demand, favorable medical coverage policies and reimbursement are facilitating broad access to Ampagni. Approximately 75% of Ampagni patients are covered by private payers. More than 250 million lives, or more than 95% of U.S.-covered lives, currently have access to reimbursement through positive medical coverage policies or pharmacy benefit plans. And positive payer coverage has been consistent with the label, clinical trials, and National Comprehensive Cancer Network, or NCCN, guidelines. As Igor will further summarize, we are manufacturing and delivering Ampagme to patients at an increasing pace. We can meet current demand by increasing capacity in headcount each month to match ongoing growth. As the launch continues, the treatment journey is also speeding up for patients. Financial clearance currently averages approximately three weeks, representing a significant reduction from four to six weeks in initial launch. ATCs are saving additional time by scheduling in parallel with financial clearance and or initiating the preconditioning regimen in conjunction with or several days prior to product arrival. We are consistently delivering on our turnaround time of 34 days from manufacturing and release testing and expect this turnaround time to decrease as the launch continues. Looking ahead, we are reaffirming our full year 2024 total product revenue guidance of $160 to $165 million. We also reiterate our full year 2025 guidance of $450 to $475 million in total product revenue. We expect a significant increase in year-over-year growth as ATCs broaden utilization and new ATCs as well as community referral networks contribute to additional demands. We anticipate significant additional revenue growth in 2026 and beyond. In the currently approved Advanced Melanoma Indication alone, Antagni and Perlucan represent more than a billion-dollar peak opportunity in the U.S. market. Globally, Ampag-B represents a multi-billion dollar opportunity to address more than 20,000 previously treated advanced melanoma patients annually in the U.S. and in our initial ex-U.S. markets. Gross margin, which Jean-Marc will highlight in a few minutes, is also expected to increase to greater than 70% over the next several years, and our third quarter gross margin is more than halfway toward that target. With a fully integrated infrastructure and growing interest in Ampag-B outside the U.S., Hyvance is well positioned to continue scaling globally. Our ex-US teams are being built and regulatory dossiers are under review, submitted or planned across multiple international markets with the potential for our first ex-US approval in the first half of 2025. The European Medicines Agency validated and accepted our marketing authorization application, or MAA, for review for all EU member states with potential approval in the second half of 2025. The Medicines and Healthcare Products Regulatory Agency in the United Kingdom is reviewing a separate MAA submission for potential approval in the first half of 2025. Our new drug submission is also underway for near-term submission in Canada and will include a prioritized review process for potential approval in mid 2025. Additional regulatory dossiers remain on track for submission in Australia and Switzerland in 2025. and will target additional markets with highly concentrated populations of advanced melanoma patients in the future. IVANCE is poised to remain the global leader in innovating, developing, and delivering current and future generations of TIL cell therapies for patients with cancer. The first approval, launch, and large-scale manufacturing with TIL cell therapy, together with our intellectual property position and deep pipeline, provide us with distinct competitive advantages. Future growth drivers include global label expansions in the frontline advanced melanoma, other tumor types, and next generation programs that we'll discuss in more detail today. I'll hand over now to Brian, our Executive Vice President of Medical Affairs, who will summarize our ATC network and U.S. field activities. Brian.