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Agenus(AGEN) - 2024 Q4 - Annual Report
AGENAgenus(AGEN)2025-03-17 20:16
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Financial Performance - Research and development revenue decreased to approximately 0.5millionin2024from0.5 million in 2024 from 38.8 million in 2023, primarily due to a 25.0millionmilestoneearnedin2023undertheBMSLicenseAgreement[440].−Non−cashroyaltyrevenuerelatedtothesaleoffutureroyaltiesfromGSKdecreasedby25.0 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 101.0millionin2024,downfrom101.0 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 234.6millionin2023,primarilyduetoa234.6 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 78.7millionin2023,mainlyduetoa78.7 million in 2023, mainly due to a 4.6 million decrease in personnel-related expenses and a 3.3milliondecreaseinsubsidiary−relatedexpenses[444].−Non−operatingincomeincreasedto3.3 million decrease in subsidiary-related expenses [444]. - Non-operating income increased to 5.8 million for the year ended December 31, 2024, from 37,000in2023,primarilyduetoa37,000 in 2023, primarily due to a 5.3 million gain on early lease terminations [446]. - Interest expense, net increased to 117.6millionfortheyearendedDecember31,2024,from117.6 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 2.18billionasofDecember31,2024,withsignificantlossesexpectedtocontinueoverthenextseveralyears[457].−Cash,cashequivalents,andshort−terminvestmentsdecreasedto2.18 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 35.7millionfromthepreviousyear[459].−Netcashusedinoperatingactivitieswas35.7 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 224.2millionin2023[465].DebtandFinancing−Long−termdebtamountsto224.2 million in 2023 [465]. Debt and Financing - Long-term debt amounts to 37.459 billion, with 3.660billiondueinlessthan1yearand3.660 billion due in less than 1 year and 33.799 billion due in 1-3 years [467]. - The company raised approximately 2.01billionthroughvariousfinancingactivitiessinceinception,includingcommonandpreferredstocksales[457].−Thecompanyisindiscussionsforfundingtosupportoperationsthroughtheplannedregistrationandlaunchstrategyforitsproductcandidates[462].ClinicalDevelopmentandCollaborations−Theleadprogram,BOT,receivedFastTrackdesignationfromtheFDAinApril2023fortreatingnon−MSI−Hand/ordMMRmetastaticcolorectalcancer[422].−Thecompanyhasestablishedcollaborationswithseveralfirms,includingBMS,Gilead,andMerck,resultinginoveradozenantibodypre−clinicalorclinicaldevelopmentprograms[423].−In2024,MercklimitedfurtherclinicaldevelopmentofMK−4830toaneoadjuvantovarianstudyincombinationwithpembrolizumabandchemotherapy[426].−Thecompanyiseligibletoreceiveuptoapproximately2.01 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 49.4millioninpotentialdevelopment,regulatory,andcommercialmilestonesfromUroGenandMerck,respectively[432].−MiNKPharmaceuticals,asubsidiary,completeditsIPOinOctober2021andisfocusedondevelopingallogeneiciNKTcelltherapies,withaPhase2trialforagenT−797activelyenrolling[436].−ThecompanyhasenteredintoaPurchaseandSaleAgreementwithLigandPharmaceuticals,sellingaportionoffuturemilestonepaymentsandroyaltiesfromvariouscollaborations[432].−ThecompanyaimstoadvanceinnovationinvaccineadjuvantdiscoverythroughitssubsidiarySaponiQx,focusingonsaponin−basedadjuvants[433].OperationalandInvestmentPolicies−Totalpaymentsestimatedforthird−partyagreementsrelatedtoclinicalstudiesareprojectedtobe49.4 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 616.5millionexpensedthroughDecember31,2024[464].−CashandcashequivalentsasofDecember31,2024,standat616.5 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].