Agenus(AGEN)2024-03-13 16:00Financial Performance - Research and development revenue increased to approximately $38.8 million in 2023 from $17.0 million in 2022, primarily due to a $25.0 million milestone under the BMS License Agreement[410]. - Non-cash royalty revenue related to GSK increased by $69.3 million to approximately $114.6 million in 2023, driven by increased net sales of GSK's vaccines containing the QS-21 STIMULON adjuvant[411]. - The accumulated deficit as of December 31, 2023, reached $1.96 billion, indicating significant losses since inception[408]. - Non-operating income decreased by $12.5 million to $37,000 for the year ended December 31, 2023, compared to $12.6 million in 2022, primarily due to minimal activity in 2023[415]. - Interest expense, net increased to $97.9 million for the year ended December 31, 2023, from $61.9 million in 2022, mainly due to increased non-cash interest related to the Royalty Purchase Agreement[416]. - The accumulated deficit reached $1.96 billion as of December 31, 2023, with expectations of significant losses continuing over the next several years[426]. - Cash, cash equivalents, and short-term investments decreased to $76.1 million as of December 31, 2023, down by $117.2 million from the previous year[431]. - Net cash used in operating activities was $224.2 million for the year ended December 31, 2023, compared to $175.4 million in 2022[437]. Research and Development - The company’s research and development expenses for 2023 were $234.6 million, up from $186.7 million in 2022[408]. - R&D expenses increased by 26% to $234.6 million for the year ended December 31, 2023, up from $186.7 million in 2022, primarily due to a $44.6 million increase in third-party services and other expenses[413]. - Total research and development expenses for 2023 amounted to $234.6 million, with significant costs associated with antibody programs[419]. - The company launched SaponiQx to innovate in adjuvant discovery and vaccine design, focusing on the next-generation QS-21 STIMULON[404]. - Botensilimab, the lead program, received Fast Track designation from the FDA for treating patients with dMMR metastatic colorectal cancer, with plans to submit a BLA by the end of 2024[395]. - The company completed enrollment of approximately 150 patients in a Phase 1 trial and 230 patients in a randomized Phase 2 trial for botensilimab by October 2023[395]. - The company is pursuing a global regulatory strategy for botensilimab, aiming for accelerated approval in the U.S. and Europe[395]. Collaborations and Agreements - The company has established collaborations with several firms, including BMS and Merck, resulting in potential milestone payments exceeding $1.32 billion from BMS alone[403][396]. - The Gilead Collaboration Agreements could yield up to $520.0 million in milestone payments and royalties on future sales[400]. - The company plans to enter into additional agreements with third-party providers, estimating total payments of $645.4 million over the term of related activities[435]. Financial Obligations and Risks - Long-term debt totals $14.384 billion, with less than $1.242 billion due in the next year[439]. - Operating leases amount to $119.297 million, with payments due between 2025 and 2036[439]. - Finance leases total $16.559 million, with $11.669 million due in the next year[439]. - The company is in discussions for potential structured financing and corporate collaborations to extend cash resources[433]. - The company is exposed to fluctuations in interest rates as it seeks debt financing and invests excess cash[448]. - Approximately 1.0% of cash used in operations for 2023 was from foreign subsidiaries, indicating exposure to foreign currency exchange rate fluctuations[447]. - The company does not currently employ hedging strategies to manage foreign currency exchange rate risks[447]. - The investment policy prohibits investing in structured investment vehicles and asset-backed commercial paper, focusing on preserving principal and maximizing yields[449]. - Non-cash interest expense related to the HCR Royalty Purchase Agreement is recorded based on estimated royalty payments from GSK, which could vary significantly[443]. - The company periodically reviews and amends its investment policy as necessary to manage credit risk and maintain liquidity[449].