Agenus Inc. (NASDAQ:AGEN) Q4 2023 Results Conference Call March 14, 2024 8:30 AM ET Company Participants Zack Armen - Head of Investor Relations Garo Armen - Chairman and Chief Executive Officer Steven O'Day - Chief Medical Officer Christine Klaskin - VP, Finance and Principal Financial and Accounting Officer Todd Yancy - Chief Strategic Advisor Conference Call Participants Emily Bodnar - H.C. Wainright Mayank Mamtani - B. Riley Securities Colleen Kusy - Baird Matthew Phipps - William Blair Operator Good mo ...

LEXINGTON, Mass.--(BUSINESS WIRE)--Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today provided a corporate update and reported financial results for the fourth quarter and full year 2023. “In 2023, Agenus made significant advances across our BOT/BAL development program. Our first target indication is metastatic, refractory colorectal cancer that is not MSI-H/dMMR, for which we are focused on pursuing accelerated approva ...

Financial 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].

Agenus Reports Fourth Quarter and Full Year 2023 Results FDA Grants Fast Track designation for BOT/BAL in metastatic, refractory colorectal cancer (CRC) patients who have failed 1st and 2nd line standard of care treatments Data from Phase 1 of BOT/BAL in refractory CRC showed durable ORR of 24% in patients with non-active liver metastases (NLM); Completed enrollment of randomized Phase 2 trial (n=230) Clinical data sets path for expansion opportunities in pancreas, lung, neoadjuvant CRC, and melanoma LEXING ...

LEXINGTON, Mass.--(BUSINESS WIRE)--Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today announced that the first preclinical data from BMS-986442 (AGEN1777) will be presented in an oral presentation at the upcoming AACR Meeting, to be held April 5 – 10, 2024 in San Diego, CA. In non-clinical assays, BMS-986442 demonstrated superior immune activation both as monotherapy and in combination with PD-(L)1 blockade compared to ...

LEXINGTON, Mass.--(BUSINESS WIRE)--Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today announced that the Compensation Committee of Agenus’ Board of Directors granted inducement awards to Nils Eckardt, Kent Barnes, and Brian Greenblatt, in connection with their appointments as Chief Medical Affairs Officer, Head of Marketing and Sales, and Vice President Commercial Operations and Business Analytics, respectively. The Compen ...

LEXINGTON, Mass.--(BUSINESS WIRE)--Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today announced that the Company will release its fourth quarter and year end 2023 financial results before the market opens on Thursday, March 14, 2024. Agenus executives will host a conference call and webcast at 8:30 a.m. ET that morning to discuss the results and provide a corporate update. Conference Call: To access dial-in numbers, plea ...

Three otherwise innocuous words -- reverse stock split -- can cause much disappointment and even sow panic in an investor community. Shareholders of clinical-stage biotech Agenus (AGEN -29.54%) experienced this vividly on Thursday when their company announced its intention to start going down that road. The stock's price fell sharply, by almost 30%, contrasting with the 0.6% gain of the benchmark S&P 500 index.Twenty shares will become oneIn a regulatory filing and a letter to its shareholders, both publish ...

Group 1: Analyst-Backed Stocks Overview - The article discusses stocks that analysts believe have the potential for significant returns, specifically those with a 10-bagger potential [2][10] - It highlights the skepticism retail investors often have towards Wall Street analysts, despite the potential for high returns [1][2] Group 2: Company Summaries - **AST SpaceMobile (ASTS)**: A satellite designer aiming to create a cellular broadband network that connects smartphones to satellites, rated a "buy" with a price target of $23 by Deutsche Bank [3][4] - **Microvast (MVST)**: A battery technology company focused on electric commercial vehicles, facing challenges in the market but rated a strong buy with an $8 price target [5][6] - **Pixelworks (PXLW)**: Provides video processing semiconductors, currently facing bearish sentiment but analysts have a price target of $14 [7][8] - **Quantum Computing (QUBT)**: Specializes in quantum computing technology, with a price target of $8.75, representing a compelling investment opportunity [9][10] - **Agenus (AGEN)**: A biotech firm focused on immunotherapy, with a large addressable market projected to grow to $200.55 billion by 2030, rated a strong buy with a $6.67 price target [11][12] - **Passage Bio (PASG)**: Focuses on genetic medicines for neurodegenerative diseases, with a market projected to reach $77.82 billion by 2029, rated a strong buy with a $10.50 price target [13][14] - **Palatin Technologies (PTN)**: Develops treatments for inflammatory and autoimmune conditions, with a market projected to grow to $141.58 billion by 2030, rated a moderate buy with a $60 target [15][16]

Industry Overview - The biotech sector has experienced a significant rally, with the SPDR S&P Biotech ETF (XBI) increasing by 31% in the last three months after being mostly down for the past three years [1] - Despite the rally, the monetary and regulatory environment remains challenging for biotech stocks [1] - Long-term investment is essential in biotech, as it can take years for drug candidates to receive FDA approval after entering clinical trials [1] Company Highlights Eli Lilly and Company (LLY) - Eli Lilly was one of the top-performing biotech stocks in 2023, with a rise of over 70% [3] - The anticipated approval of the obesity drug Zepbound in November 2023 is a key catalyst for the company's performance [3] - The company is also focused on donanemab, a clinical-stage drug for Alzheimer's disease, with an FDA decision expected in early 2024 [3][4] - LLY has a forward price-to-earnings (P/E) ratio of approximately 97x, indicating it is expensive relative to historical values, but is projected to have earnings growth of 91% in the next 12 months [4] Amylyx (AMLX) - Amylyx transitioned from a clinical-stage to a commercial-stage company after receiving FDA approval for Relyvrio, its treatment for ALS [6] - The company has reported three profitable quarters and anticipates a 79% increase in earnings over the next year [6] - Despite this, AMLX stock has decreased by 64% in the past year, potentially due to heavy short interest and concerns over slowing revenue growth [6] - Upcoming Phase 3 trial results from the PHOENIX clinical trial may provide additional data to support approval by the European Medicines Agency (EMA) [6] Agenus (AGEN) - Agenus is a clinical-stage company focused on developing cancer immunotherapies [7] - The company is working on a Biologics License Application (BLA) for accelerated approval of its lead candidate, botensilimab, targeting HER-positive metastatic colorectal cancer [7] - Although Agenus is a penny stock and not widely covered by analysts, four out of five analysts have rated it as a Strong Buy [8]