Iovance Biotherapeutics(IOVA) - 2024 Q4 - Annual Report

FDA Approvals and Product Launches - Amtagvi® (lifileucel) received FDA approval on February 16, 2024, for treating adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody [596]. - The company plans to launch Amtagvi® in additional markets, including the EU, UK, Canada, Switzerland, and Australia, with potential annual addressable patients exceeding 20,000 [588]. - The iCTC is the first FDA-approved facility for commercial TIL cell therapy, allowing the company to control manufacturing capacity and product quality [606]. Manufacturing and Capacity - The iCTC manufacturing facility has a capacity to treat several thousand cancer patients annually, with ongoing expansion expected to increase capacity to over 5,000 patients per year [606]. - The company has conducted over 700 patient treatments with TIL cell therapy products in clinical trials, demonstrating the viability of its proprietary manufacturing processes [605]. Financial Performance - Revenue for the year ended December 31, 2024, increased by $162.9 million, or 13,698$103.6 million in 2024, while Proleukin® contributed $60.5 million, marking a significant increase in product sales [631]. - The company began generating revenue for Amtagvi® in the second quarter of 2024 following its FDA approval in February 2024 [631]. Clinical Trials and Research Development - The company is conducting multiple clinical trials for lifileucel in various cancers, including advanced melanoma, non-small cell lung cancer, and endometrial cancer, with significant patient enrollment expected [612]. - IOV-4001, a next-generation TIL cell therapy, is currently in a Phase 2 clinical trial for advanced melanoma and NSCLC, utilizing TALEN® gene-editing technology [612]. - IOV-5001, another next-generation TIL therapy, is in IND-enabling studies, with a pre-IND meeting planned with the FDA in Q1 2025 [613]. Expenses and Financial Outlook - The company anticipates an increase in selling, general, and administrative expenses as it executes the launch of Amtagvi® and expands its market presence [627]. - Research and development expenses are expected to continue as the company conducts clinical trials for various product candidates, with a potential decrease in these expenses as commercial activities increase [625]. - The company expects to continue incurring net losses in the future as it invests in clinical and internal research and development programs [644]. Intellectual Property - The company has established a leading intellectual property portfolio with over 75 U.S. patents related to TIL cell therapy, which are expected to extend to October 2037 or January 2038 [615]. Cash Flow and Liquidity - As of December 31, 2024, the company had$330.1 million in cash, cash equivalents, and investments, indicating a strong liquidity position [659]. - Cash used in operating activities decreased by $8.8 million to$353.0 million in 2024, reflecting improved revenue generation from product commercialization [669]. Acquisitions and Inventory - Proleukin® (aldesleukin) was acquired in May 2023, providing an additional revenue source and securing the supply chain for the treatment regimen [603]. - The Proleukin® inventory previously held by distributors has been substantially sold, leading to significant re-stocking demand from specialty distributors in the second and third quarters of 2024 [631]. Tax and Regulatory Matters - The income tax benefit for 2023 was $3.5 million, resulting from the realization of deferred taxes for operations in the UK [657]. - The company is currently evaluating the impact of ASU 2023-09 on its consolidated financial statements, effective for fiscal year 2025 [703]. Market and Currency Considerations - The majority of product sales during the year ended December 31, 2024, were denominated in U.S. dollars, with some sales in foreign currencies [708]. - Foreign currency transaction gains and losses were immaterial for the years ended December 31, 2024, and 2023 [708].