Agenus(AGEN)2025-03-17 20:16Financial Performance - Research and development revenue decreased to approximately $0.5 million in 2024 from $38.8 million in 2023, primarily due to a $25.0 million milestone earned in 2023 under the BMS License Agreement [440]. - Non-cash royalty revenue related to the sale of future royalties from GSK decreased by $13.6 million to approximately $101.0 million in 2024, down from $114.6 million in 2023, attributed to decreased net sales of GSK's vaccines containing the QS-21 STIMULON adjuvant [441][442]. - The accumulated deficit as of December 31, 2024, reached $2.18 billion, indicating significant losses since inception [438]. - R&D expenses decreased by 34% to $155.5 million for the year ended December 31, 2024, down from $234.6 million in 2023, primarily due to a $52.7 million decrease in third-party services and a $11.4 million decrease in personnel-related expenses [443]. - G&A expenses decreased by 9% to $71.9 million for the year ended December 31, 2024, from $78.7 million in 2023, mainly due to a $4.6 million decrease in personnel-related expenses and a $3.3 million decrease in subsidiary-related expenses [444]. - Non-operating income increased to $5.8 million for the year ended December 31, 2024, from $37,000 in 2023, primarily due to a $5.3 million gain on early lease terminations [446]. - Interest expense, net increased to $117.6 million for the year ended December 31, 2024, from $97.9 million in 2023, mainly due to increased non-cash interest related to the Royalty Purchase Agreement [447]. - The accumulated deficit reached $2.18 billion as of December 31, 2024, with significant losses expected to continue over the next several years [457]. - Cash, cash equivalents, and short-term investments decreased to $40.4 million as of December 31, 2024, down $35.7 million from the previous year [459]. - Net cash used in operating activities was $158.3 million for the year ended December 31, 2024, compared to $224.2 million in 2023 [465]. Debt and Financing - Long-term debt amounts to $37.459 billion, with $3.660 billion due in less than 1 year and $33.799 billion due in 1-3 years [467]. - The company raised approximately $2.01 billion through various financing activities since inception, including common and preferred stock sales [457]. - The company is in discussions for funding to support operations through the planned registration and launch strategy for its product candidates [462]. Clinical Development and Collaborations - The lead program, BOT, received Fast Track designation from the FDA in April 2023 for treating non-MSI-H and/or dMMR metastatic colorectal cancer [422]. - The company has established collaborations with several firms, including BMS, Gilead, and Merck, resulting in over a dozen antibody pre-clinical or clinical development programs [423]. - In 2024, Merck limited further clinical development of MK-4830 to a neoadjuvant ovarian study in combination with pembrolizumab and chemotherapy [426]. - The company is eligible to receive up to approximately $136.3 million and $49.4 million in potential development, regulatory, and commercial milestones from UroGen and Merck, respectively [432]. - MiNK Pharmaceuticals, a subsidiary, completed its IPO in October 2021 and is focused on developing allogeneic iNKT cell therapies, with a Phase 2 trial for agenT-797 actively enrolling [436]. - The company has entered into a Purchase and Sale Agreement with Ligand Pharmaceuticals, selling a portion of future milestone payments and royalties from various collaborations [432]. - The company aims to advance innovation in vaccine adjuvant discovery through its subsidiary SaponiQx, focusing on saponin-based adjuvants [433]. Operational and Investment Policies - Total payments estimated for third-party agreements related to clinical studies are projected to be $660.7 million, with $616.5 million expensed through December 31, 2024 [464]. - Cash and cash equivalents as of December 31, 2024, stand at $40.4 million, exposed to interest and foreign currency exchange rate changes [477]. - Approximately 2.1% of cash used in operations for the year ended December 31, 2024, was from foreign subsidiaries, indicating exposure to foreign currency exchange rate fluctuations [476]. - The company does not currently employ specific strategies to manage foreign currency exchange rate risks, such as derivatives or hedging [476]. - The investment policy aims to preserve principal, maintain liquidity, and maximize yields, prohibiting investments in structured vehicles and asset-backed commercial paper [478]. - Non-cash interest expense related to royalty financing transactions is recorded based on estimated royalty payments, which may vary due to several factors [473]. - The company is exposed to fluctuations in interest rates as it seeks debt financing and invests excess cash [477]. - The company periodically reviews and amends its investment policy as necessary to mitigate credit risk [478]. - The company has identified critical accounting policies that require complex judgments and estimates, which may differ from actual results [469].