Iovance Biotherapeutics, Inc.

Welcome to the Iovance Biotherapeutics conference call to discuss second quarter 2024 results and recent corporate updates. My name is Daniel and I will be your operator for today's call. At this time all participants are in a listen-only mode. Later we will conduct a question and answer session. Please note that this conference is being recorded. I'll now turn the call over to Sarah Pellegrino, Senior Vice President, Investor Relations and Corporate Communications at Iovance. Sarah, you may begin.

Thank you, operator. Good afternoon and welcome to Iovance conference call and webcast to discuss our second quarter and first half 2024 results and corporate updates. Dr. Fred Vose, our Interim President and Chief Executive Officer, will provide an introduction and summarize key updates for our U.S. commercial launch of AMTAGV, including revenue guidance and our pipeline program. Jim Ziegler, EVP Commercial, will highlight additional details of the U.S. commercial launch of AMTAGV in advanced melanoma. Dr. Igor Belinsky, Chief Operating Officer, will comment on our commercial manufacturing experience and capacity expansion plan. John Mark Bellamine, CFO, will review our financial results including revenue and financial outlook, and Dr. Frederick Finkenstein, Chief Medical Officer, will review key clinical pipeline updates. Dr. Brian Gassman, EVP Medical Affairs, and Dr. Raj Puri, EVP Regulatory Affairs, are also on the call and available for the Q&A session. Earlier this afternoon, we issued a press release that could 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 IOVANS' 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 FDC filings. 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 am pleased to host this afternoon's conference call to discuss our 2024 second quarter and first half results. We've had a productive year so far at I-Advance following our first FDA approval and a successful start in the U.S. commercial launch of Antagni for patients with advanced melanoma. First, we were very pleased with the exceptional demand for Ampagni. Our second quarter product revenue was $31.1 million, inclusive of recognized revenue for Ampagni and Prolucan. Ampagni revenue is recognized upon infusion, while Prolucan revenue is recognized upon delivery, typically a few months prior to Ampagni infusion, providing a strong leading indicator of demand of future Ampagni revenue. The initial quarter of product revenue from our U.S. launch demonstrates early success from our team's execution, as well as the unmet need, high awareness, broad patient access, and motivated, authorized treatment centers, or ATCs. With the antagonist already showing a meaningful benefit for patients treated in the commercial setting, we expect continued launch momentum, which I'll return to in a moment. As Jim will discuss, we have a very engaged network of more than 50 current ATCs. These ATCs are proving that they have the training, infrastructure, and capabilities to treat patients with antagony. We also remain on track to have at least 70 ATCs by the end of the year, representing the largest ever initial ATC network for a cell therapy launch. We've also started our community referral activities to drive additional demand for these ATCs. Through early success with reimbursement and a strong logistics and scheduling collaboration between IVAN and the ATCs, Time of treatment is also becoming faster for patients. In addition, our commercial manufacturing capabilities are successfully delivering AMTAG-B at an increasing pace. The key takeaways, as Igor will summarize, are that we are staffed to provide manufacturing slots to meet current and expected demand. We are scaling up manufacturing according to our growth projections. We have increased capacity and headcount each month since launch and continue ramping up to match ongoing demand growth. Turning back to launch momentum, this afternoon's press release, we also introduced revenue guidance for the third quarter of full year 2024 and for 2025. This guidance is based upon our ongoing experience and confidence in the strong uptake and significant quarter-over-quarter growth that Antagni demand in corresponding pro-leukin sales for the foreseeable future. We used our visibility into the growth rate of infusions adoption act across our ATC network, manufacturing capacity, and additional launch dynamics to prepare this guidance. In the third quarter, we expect total product revenue within the range of $53 to $55 million. Notably, more than 55 patients have been infused with Ampagni since the first commercial infusion in April of 2024, including 25 patients infused in the second quarter. More than 30 patients have already been infused, and distributors are restocking Prolucan since the start of the third quarter. Many more infusions are scheduled or anticipated before quarter end in support of our guidance. For full year 2024, we anticipate total product revenue for Amtagby and Perlucan of $160 to $165 million. We expect the full year 2024 will reflect continued demand growth for Amtagby and corresponding sales for Perlucan. For full year 2025, the first calendar year of our U.S. launch, first full calendar year of our U.S. launch, We expect significant year-over-year growth driven by scale-up in existing and new ATCs and robust community referral networks contributing to additional demand. As a result, we anticipate total product revenue will increase to $450 to $475 million in the full year of 2025. In 2026 and beyond, Antagni and Prolucan are expected to continue to drive significant additional revenue growth. These products represent more than a billion-dollar peak opportunity in the U.S. market in the currently approved indication alone. Future revenue growth drivers also include a wider geographic footprint for Antagni and previously treated advanced melanoma, as well as U.S. and global label expansions to frontline advanced melanoma, non-small cell lung cancer, and other indications, as we'll discuss later on the call. Growth margins are also expected to increase to greater than 70% over the next several years. This reflects the long-term commercial strength for EmpagV and Prolucan and highlights the strong future for Iovance. Globally, EmpagV represents a multi-billion dollar opportunity to address more than 20,000 previously treated advanced melanoma patients annually across the U.S. in our initial planned geographic program. Following our recent regulatory submission in the European Union, we remain on track for additional submissions in the U.K. and Canada this year and Australia and Switzerland in 2025, with commercial launches to follow. IVANCE is well-positioned to build upon our existing commercial success and continue growing globally. In addition to AMTAG-B, our robust and exciting pipeline may help even more patients with solid tumors obtain potentially curative medicines. Our programs include two registrational trials and other indications, and we are continuously innovating with next-generation TIL therapies. Frederick will discuss our pipeline in further detail on this call. The first approval, launch, and large-scale manufacturing of TIL cell therapy together with our intellectual property position in DeepPipeline, provide us with distinct competitive advantages. As a fully integrated company, Iovance is well-positioned to maintain the global leader in innovating, developing, and delivering pill cell therapies for patients with cancer. I'll now hand over to Jim, our Executive Vice President of Commercial, who will summarize our U.S. commercial activities. Jim?