Iovance Biotherapeutics, Inc., a commercial-stage biopharmaceutical company, reported total product revenue of $263.5 million for the year ended December 31, 2025, a 61% increase compared to $164.1 million in 2024. This growth was primarily driven by the commercial launch of Amtagvi® (lifileucel) in February 2024, contributing $220.0 million in revenue, alongside $43.5 million from Proleukin® (aldesleukin) sales. The company's net loss for 2025 was $391.0 million, compared to a net loss of $372.2 million in the previous year. As of December 31, 2025, Iovance held $303.0 million in cash, cash equivalents, short-term investments, and restricted cash.
The company's cost of sales, excluding depreciation and amortization, increased by 86% to $173.2 million in 2025, primarily due to increased Amtagvi® sales and a $9.5 million increase in excess and obsolescence reserve related to Proleukin® inventory. Research and development expenses rose by 9% to $300.3 million, driven by increased payroll, clinical trial costs, and license costs, partially offset by decreased commercial manufacturing costs. Selling, general, and administrative expenses remained relatively flat at $152.3 million, with increased distribution and other costs offset by decreased payroll expenses.
Key operational developments included the transition of all Amtagvi® and lifileucel manufacturing activities to the Iovance Cell Therapy Center (iCTC) in Philadelphia, with the contract manufacturer agreement terminating in the first quarter of 2026. Iovance is also progressing with clinical trials for lifileucel in advanced non-small cell lung cancer (NSCLC) and frontline advanced melanoma. The company plans to commence a registrational trial in previously treated advanced undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma in the second quarter of 2026. As of December 31, 2025, Iovance had 975 employees, with 775 engaged in research and development and commercial manufacturing activities.
Iovance's strategy focuses on driving the commercial success of Amtagvi® in previously treated advanced melanoma, educating healthcare professionals, providing operational support at authorized treatment centers, and collaborating with payors to facilitate reimbursement. The company is also expanding its ATC network and pursuing regulatory approvals in additional global markets, with potential approvals pending in the UK, Australia, and Switzerland. In the European Union, the company plans to resubmit a centralized marketing authorization application in 2026.
Looking ahead, Iovance anticipates continued investment in clinical and internal research and development programs, as well as ongoing execution of the Amtagvi® launch. The company believes it has sufficient capital to fund its anticipated operating expenses and capital expenditures for at least the next twelve months following the issuance of its consolidated financial statements. However, the company may need to raise additional capital in the future to complete the development of its product candidates and commercialization of its products.
About IOVANCE BIOTHERAPEUTICS, INC.
Iovance Biotherapeutics develops personalized TIL (tumor infiltrating lymphocyte) cell therapies for solid tumor cancers, including melanoma and lung cancer. Its core products include Amtagvi, the first FDA-approved TIL therapy for melanoma, and Proleukin, an IL-2 product. The company focuses on manufacturing scalable, proprietary processes and advancing innovative, genetically modified TIL treatments to target diverse, patient-specific neoantigens in global oncology markets.
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