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Syndax(SNDX) - 2024 Q4 - Annual Report
SNDXSyndax(SNDX)2025-03-03 12:05
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Financial Performance - Revuforj generated net product revenue of 7.7millionforthetwelvemonthsendedDecember31,2024,followingitsFDAapprovalonNovember15,2024[348].−Thecompanyreportednetlossesof7.7 million for the twelve months ended December 31, 2024, following its FDA approval on November 15, 2024[348]. - The company reported net losses of 318.8 million, 209.4million,and209.4 million, and 149.3 million for the years ended December 31, 2024, 2023, and 2022, respectively[344]. - Total revenue for the year ended December 31, 2024, was 23.68million,anincreaseof23.68 million, an increase of 23.68 million compared to 2023[373]. - Net product revenue from sales of Revuforj in the United States was 7.68million,withmilestonerevenueof7.68 million, with milestone revenue of 16 million achieved through collaboration agreements[374][375]. - Total operating expenses for 2024 were 363.35million,anincreaseof363.35 million, an increase of 133.4 million from 2023[373]. - As of December 31, 2024, the company had an accumulated deficit of 1.2billionandanticipatescontinuingtoincursignificantlossesforatleastthenextseveralyears[1].CashandInvestments−AsofDecember31,2024,thecompanyhadcash,cashequivalents,andinvestmentstotaling1.2 billion and anticipates continuing to incur significant losses for at least the next several years[1]. Cash and Investments - As of December 31, 2024, the company had cash, cash equivalents, and investments totaling 692.4 million[344]. - Net cash used in operating activities for the year ended December 31, 2024, was 274.9million,primarilyduetoanetlossof274.9 million, primarily due to a net loss of 318.8 million adjusted for non-cash items[4]. - Net cash provided by financing activities for the year ended December 31, 2024, was 353.4million,mainlyfromproceedsof353.4 million, mainly from proceeds of 343.7 million from the Royalty Pharma Purchase and Sale agreement[6]. - Net cash provided by investing activities for the year ended December 31, 2024, was 219.8million,resultingfrom219.8 million, resulting from 337.3 million in proceeds from the maturities of available-for-sale marketable securities[5]. - The company had cash, cash equivalents, and short-term and long-term investments totaling 692.4millionasofDecember31,2024[9].−Thecompanyanticipatesneedingadditionalcapitaltofundoperations,whichmayleadtodilutionofexistingstockholders′ownershipinterests[1].ExpensesandFutureProjections−Researchanddevelopmentexpensesareexpectedtocontinuetogrowsignificantlyasthecompanyadvancesitsproductcandidates[356].−Selling,generalandadministrativeexpensesareanticipatedtoincreaseasthecompanyexpandsitsworkforcetosupportresearchandcommercializationefforts[360].−Researchanddevelopmentexpensesincreasedby692.4 million as of December 31, 2024[9]. - The company anticipates needing additional capital to fund operations, which may lead to dilution of existing stockholders' ownership interests[1]. Expenses and Future Projections - Research and development expenses are expected to continue to grow significantly as the company advances its product candidates[356]. - Selling, general and administrative expenses are anticipated to increase as the company expands its workforce to support research and commercialization efforts[360]. - Research and development expenses increased by 78.6 million to 241.65millionin2024,primarilyduetocostsrelatedtoRevumenibandAxatilimab[377].−Selling,generalandadministrativeexpensesroseby241.65 million in 2024, primarily due to costs related to Revumenib and Axatilimab[377]. - Selling, general and administrative expenses rose by 54 million to 120.88million,drivenbyincreasedcommercialreadinessandpersonnelcosts[378].−Thecompanyanticipatesfuturecapitalrequirementswilldependonclinicaltrialoutcomes,regulatoryapprovals,andmarketacceptanceofproductcandidates[388].TaxandRegulatoryMatters−Thecompanyhadfederalandstatetaxnetoperatinglosscarryforwardsofapproximately120.88 million, driven by increased commercial readiness and personnel costs[378]. - The company anticipates future capital requirements will depend on clinical trial outcomes, regulatory approvals, and market acceptance of product candidates[388]. Tax and Regulatory Matters - The company had federal and state tax net operating loss carryforwards of approximately 181.0 million and 97.5million,respectively,asofDecember31,2024[7].−Thecompanyrecordedavaluationallowanceonalldeferredtaxassets,includingthoserelatedtonetoperatinglossandresearchanddevelopmenttaxcreditcarryforwards[10].ProductDevelopmentandCollaborations−ThecompanyplanstosubmitasupplementalNewDrugApplicationforrevumenibinQ22025forthetreatmentofR/Racutemyeloidleukemia[344].−Thecompanyisexploringtheuseofrevumenibinsolidtumors,specificallymetastaticcolorectalcancer[344].−Thecompanyrecognized97.5 million, respectively, as of December 31, 2024[7]. - The company recorded a valuation allowance on all deferred tax assets, including those related to net operating loss and research and development tax credit carryforwards[10]. Product Development and Collaborations - The company plans to submit a supplemental New Drug Application for revumenib in Q2 2025 for the treatment of R/R acute myeloid leukemia[344]. - The company is exploring the use of revumenib in solid tumors, specifically metastatic colorectal cancer[344]. - The company recognized 3.5 million in milestone revenue in Q2 2024 from the Eddingpharm license agreement and 12.5millioninQ32024fromtheIncyteCollaborationAgreement[353].−ApurchaseandsaleagreementwithRoyaltyPharmawasexecutedfor12.5 million in Q3 2024 from the Incyte Collaboration Agreement[353]. - A purchase and sale agreement with Royalty Pharma was executed for 350 million, granting rights to receive 13.8% of quarterly net sales of Niktimvo[384]. - The company has not generated substantial product revenue to date, relying on equity offerings and collaborations for financing[388].