Iovance Biotherapeutics, Inc.

Good day, and thank you for standing by. Welcome to the Iovance Biotherapeutics first quarter 2025 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 press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 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, IR, and Corporate Communications. Please go ahead.

Good afternoon, and thank you for joining the IOVANCE conference call and webcast to discuss our first quarter 2025 financial results, as well as recent corporate updates. Dr. Fred Vogt, our Interim Chief Executive Officer and President, We'll provide an introduction and focus on the U.S. commercial launch of Amtagvi, including revenue and revenue guidance. Dan Kirby, Chief Commercial Officer, will discuss the Amtagvi commercial launch. Dr. Igor Balinski, our Chief Operating Officer, will provide a manufacturing update. John Mark Bellaman, our CFO, will review our financial results, including revenue and revenue guidance, gross margin and cash burn guidance. and Dr. Frederick Pinkenstein, our Chief Medical Officer, will summarize key pipeline programs. Additional members of our leadership team, including Dr. Raj Puri, our Chief Regulatory Officer, Dr. Brian Gassman, our EVP of Medical Affairs, will be available for the Q&A session. Earlier this afternoon, we issued a press release that is available 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 IOAMS'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 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, and welcome to the I-Advanced first quarter 2025 conference call. We are four quarters into our U.S. launch of Antagni, the first FDA-approved kill cell therapy and the first treatment for patients with advanced melanoma who progress following anti-P1 treatment and, if appropriate, targeted therapy. In the first 12 months of our U.S. launch, we've executed towards our long-term goal, adoption goals, and generated more than $210 million in revenue. This includes infusions from nearly 300 Antagni patients in the first launch year, starting with our first infusions in April of 2024. Total first quarter product revenue was $49.3 million, including $43.6 million from more than 80 Antagni infusions and $5.7 million from Prolucan sales. Following steady growth throughout 2024, revenue was lower in the first quarter of this year, driven by three key contributors. First, our internal manufacturing facility, the ICTC, completed annual scheduled maintenance in December of last year, as we previously discussed on last quarter's call. As a result of limited production starts from multi-week antagonist manufacturing across our network, capacity was reduced by more than half for about one month. In addition, volume was impacted by higher rates of patient drop-off and lower manufacturing success rates, but it's since rebounded. Today, we are seeing healthy demand with a record number of production starts into the second quarter. Lower proleukin sales were the second factor contributing to lower first quarter revenue. We expect two of the three largest U.S. wholesalers to start replenishing proleukin in line with growing antagonism in the second quarter. We're also growing the other components of our franchise, including sales of proleukin to third parties for use with manufacturing and clinical research. The third contributor to first quarter revenue was the variable pace at which ATCs began treating patients, as this differs from center to center. For context, 16% of ATCs have treated more than 10 patients. Our ATCs have ample room to grow, and we anticipate near-term contributions from ATCs that came online in the latter half of 2024 into 2025. We are also confident in our growth prospects under our new Chief Commercial Officer, Dan Kirby. Dan brings invaluable leadership experience in cell therapy commercial organizations since the earliest developments in the field. In less than three months, Stan is already strengthening our commercial operations to drive ADC adoption and amplify earlier community referrals to our ADC network. The commercial team is working aggressively to implement key learnings from the first year as we continue to execute our U.S. launch. We are also excited about upcoming milestones related to our ex-U.S. launch expansion and pipeline development to lung cancer and beyond. We anticipate three potential approvals for AMTAGME in the United Kingdom, Canada, and the European Union. And additional regulatory submissions are also underway in Australia and Switzerland. We are on track to report updated data from our registrational trial of blephalusole and previously treated advanced non-small cell lung cancer and first clinical data in endometrial cancer. And we continue to advance our robust pipeline of next-generation toll cell therapies for patients with solid tumors. Looking ahead, I will briefly comment on our revised full-year revenue guidance and cash spend outlook. We revised our guidance to between $250 and $300 million in total product revenue for the full year 2025. We consider our experience with growth trajectories at the ATCs, timelines for new ATCs to begin treating their first patients, and expectations for large community practices and community referrals to drive momentum in the second half of 2025. These demand trends are consistent with the trajectory of other cell therapy launches moving from year one to year two. After aligning our manufacturing slot plans with our new demand forecast, we are maintaining our prior cash runway guidance into the second half of 2026. We remain confident in a peak sales opportunity of more than $1 billion in the U.S. and more than $2 billion globally for Ampagni and the current approved indication. We also continue to expect the gross margin can exceed 70% in the coming years. Ampagni and Perlucan are showing steady growth in the second quarter and will accelerate in the second half of the year. Current momentum is strong, and we project between 100 and 110 commercial patient infusions in the second quarter. We are also motivated by positive feedback from key opinion leaders and patient success stories that reinforce the unmet medical need and value of MTAGV. On a macro level, as Igor will describe, we are well prepared to supply ongoing demand to deliver commercial MTAGV, as well as our investigational tilt products to patients around the world. I-Advance is competitively positioned with a fully U.S.-based patent portfolio and manufacturing network. Tariff should have a minimal impact on Antagni and Prolucan. I'm happy to go into more detail during the Q&A, and we'll now turn the call to Dan Kirby for a detailed commercial launch update. Thank you, Fred.