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MEDTECH ACQUISIT(MTAC) - 2024 Q3 - Quarterly Report
MTACMEDTECH ACQUISIT(MTAC)2024-11-14 13:34

Financial Performance - Revenue increased by 2.2million,or41.52.2 million, or 41.5%, for the three months ended September 30, 2024, compared to the same period in 2023, primarily due to increased sales of TriNav[226]. - Revenue increased by 8.4 million, or 65.5%, for the nine months ended September 30, 2024, compared to the same period in 2023, driven by sales of TriNav[238]. - Gross profit increased by 1.7million,or37.81.7 million, or 37.8%, for the three months ended September 30, 2024, with gross margin decreasing to 86.3% from 88.7%[229]. - Gross profit increased by 7.5 million, or 69.8%, for the nine months ended September 30, 2024, with gross margin increasing to 86.4% from 84.2%[241]. - Net losses amounted to 19.9millionfortheninemonthsendedSeptember30,2024,withcashandcashequivalentsofapproximately19.9 million for the nine months ended September 30, 2024, with cash and cash equivalents of approximately 11.3 million at the same date[250]. Expenses - Cost of goods sold increased by 0.4million,or70.50.4 million, or 70.5%, for the three months ended September 30, 2024, driven by higher production volumes[228]. - R&D expenses decreased by 5.3 million, or 55.6%, for the three months ended September 30, 2024, primarily due to reduced clinical trial expenses[230]. - Sales and marketing expenses increased by 1.4million,or30.91.4 million, or 30.9%, for the three months ended September 30, 2024, mainly due to higher payroll and travel expenses[231]. - General and administrative expenses decreased by 4.3 million, or 47.6%, for the three months ended September 30, 2024, due to prior period expenses related to the Business Combination[232]. - R&D expenses decreased by 7.3million,or33.37.3 million, or 33.3%, for the nine months ended September 30, 2024, primarily due to an 8.1 million reduction in clinical trial expenses related to nelitolimod[242]. - Sales and marketing expenses increased by 7.4million,or64.77.4 million, or 64.7%, for the nine months ended September 30, 2024, driven by higher payroll and travel expenses of 6.6 million due to increased headcount[243]. - General and administrative expenses decreased by 4.2million,or23.94.2 million, or 23.9%, for the nine months ended September 30, 2024, primarily due to prior period expenses related to legal and consulting work that were not repeated[244]. Funding and Capital - TriSalus reported a total of 12.4 million raised from the sale of 1,874,867 shares of common stock under the SEPA during the nine months ended September 30, 2024[200]. - The OrbiMed Credit Agreement provides for up to 50.0millioninseniorsecuredtermdebt,withaninitialcommitmentof50.0 million in senior secured term debt, with an initial commitment of 25.0 million made available on April 30, 2024[201]. - Net cash used in operating activities was 35.1millionfortheninemonthsendedSeptember30,2024,comparedto35.1 million for the nine months ended September 30, 2024, compared to 41.4 million for the same period in 2023[252]. - Net cash provided by financing activities was 34.9millionfortheninemonthsendedSeptember30,2024,consistingof34.9 million for the nine months ended September 30, 2024, consisting of 12.6 million from the sale of common stock and 22.4millionfromtheOrbiMedCreditAgreement[257].−Thecompanyexpectstorequiresubstantialadditionalfundingtosupportongoingoperationsandfuturecommercializationefforts,particularlyforTriNavandnelitolimod[259].ClinicalandProductDevelopment−TheTriNavInfusionSystemreceivedapermanentHCPCScodeeffectiveJanuary1,2024,allowingforreimbursementforproceduresinvolvingthedevice[192].−ThecompanylaunchedtheTriNavLVInfusionSystemandTriGuideGuidingCathetertoexpanditsaddressableliverembolizationmarket[193].−TriSalusisconductingPhase1andPhase1bclinicaltrialsfornelitolimod,withdatafromthepancreaticcancertrialexpectedin2025[195].−TheDELIVERprogramaimstoevaluatetheTriNavsystemacrosscomplexpatientpopulationstovalidatetheclinicaleffectsofthePEDDtechnology[208].−Thecompanyplanstoinitiatethe"PROTECT"clinicalstudytocomparetheTriNavapproachwithconventionalsurgicalmethods[209].BusinessTransactions−TheBusinessCombinationwithMedTechAcquisitionCorporationwascompletedonAugust10,2023,withanaggregateconsiderationof22.4 million from the OrbiMed Credit Agreement[257]. - The company expects to require substantial additional funding to support ongoing operations and future commercialization efforts, particularly for TriNav and nelitolimod[259]. Clinical and Product Development - The TriNav Infusion System received a permanent HCPCS code effective January 1, 2024, allowing for reimbursement for procedures involving the device[192]. - The company launched the TriNav LV Infusion System and TriGuide Guiding Catheter to expand its addressable liver embolization market[193]. - TriSalus is conducting Phase 1 and Phase 1b clinical trials for nelitolimod, with data from the pancreatic cancer trial expected in 2025[195]. - The DELIVER program aims to evaluate the TriNav system across complex patient populations to validate the clinical effects of the PEDD technology[208]. - The company plans to initiate the "PROTECT" clinical study to compare the TriNav approach with conventional surgical methods[209]. Business Transactions - The Business Combination with MedTech Acquisition Corporation was completed on August 10, 2023, with an aggregate consideration of 220.0 million[196]. - The expiration of the TPT payment program on December 31, 2023, may impact the pricing and gross margins of TriNav[199]. Accounting and Reporting - No significant changes in critical accounting policies during the nine months ended September 30, 2024, compared to the previous year[269]. - Critical accounting policies require greater judgment and estimates, which may lead to actual results differing from estimates[269]. - The company is classified as a smaller reporting company and is not required to provide additional market risk information[270].