Iovance Biotherapeutics (IOVA) FY 2025 Conference June 11, 2025 01:20 PM ET Speaker0 Good afternoon everyone. Thanks so much for joining us. I'm really pleased to be joined by Brian Gasman, EVP of Medical Affairs, and Dan Kirby, CCO of Iovance. Thank you both for joining us. Speaker1 Thank you. Speaker0 Dan, maybe I can start with you here. Given Amtagni has been on the market now for over a year, what have been the biggest learnings from this launch? And what has been maybe easier in some ways, or what has ...

Financial Data and Key Metrics Changes - Total product revenue for Q1 2025 was $49.3 million, including $43.6 million from EMTAGV and $5.7 million from Proleukin, compared to $700,000 for Proleukin in Q1 2024 [40][41] - Net loss for Q1 2025 was $116.2 million or $0.36 per share, compared to a net loss of $113 million or $0.42 per share for Q1 2024 [40] - Average standard gross margin for the first four launch quarters was 32%, with a standard gross margin of 10% for Q1 2025, negatively impacted by lower revenue and higher cost of sales [42] Business Line Data and Key Metrics Changes - The U.S. commercial launch of EMTAGV generated over $210 million in revenue in its first year, with nearly 300 patients infused [7] - First quarter product revenue was lower due to reduced manufacturing capacity from scheduled maintenance, higher patient drop-off rates, and lower manufacturing success rates [8][9] - The company anticipates between 100 and 110 commercial patient infusions in Q2 2025, with a strong demand trend [15] Market Data and Key Metrics Changes - The company expects to report updated data from its registrational trial of lefalusol in previously treated advanced non-small cell lung cancer and first clinical data in endometrial cancer [13] - The company is on track for potential approvals for EMTAGV in the UK, Canada, and the EU, with additional regulatory submissions underway in Australia and Switzerland [13] Company Strategy and Development Direction - The company revised its full-year revenue guidance to between $250 million and $300 million for 2025, focusing on ATC engagement and training to drive revenue growth [45] - The company is expanding its ATC network and enhancing community referrals to improve patient access to EMTAGV [19][27] - The company aims to establish EMTAGV as the preferred treatment option for appropriate patients, emphasizing education for medical oncologists [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in growth prospects under the new Chief Commercial Officer, who is enhancing commercial operations to drive ATC adoption [12] - The company is well-prepared to supply ongoing demand and deliver commercial products globally, with minimal impact from tariffs [36] - Management highlighted the importance of operational efficiencies and economies of scale to optimize costs and improve gross margins over time [36] Other Important Information - The company has a robust patent portfolio with approximately 280 granted or allowed patents, providing exclusivity through at least February 2042 [37] - The company is focused on driving operational efficiencies and reducing expenses while maintaining a cash runway into the second half of 2026 [45] Q&A Session Summary Question: Insights on revised guidance and patient uptake - Management confirmed strong demand and confidence in the guidance of 110 patients for Q2 2025 [56] Question: Barriers for ATCs with lower patient infusions - Management noted that only a few ATCs that infused more than 10 patients were involved in clinical trials, and they are working to improve the performance of other ATCs [58][59] Question: Clarification on revenue guidance and infusion assumptions - Management indicated that the guidance is conservative and expects continued growth throughout the year, driven by increased adoption and new ATCs [64][67] Question: Manufacturing success rates and patient drop-offs - Management explained that the increase in patient drop-offs was related to patient selection and tumor procurement techniques, with confidence in a rebound in Q2 [71][84] Question: Strategies for improving ATC performance - Management is implementing a "white glove service" to assist new surgeons and centers in optimizing their processes for better outcomes [102]