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TriSalus Life Sciences(TLSI) - 2024 Q2 - Quarterly Report

Financial Performance - Revenue increased by 2.8million,or59.72.8 million, or 59.7%, for the three months ended June 30, 2024, compared to the same period in 2023, primarily due to increased sales of TriNav[175]. - Gross profit increased by 2.6 million, or 68.0%, for the three months ended June 30, 2024, with gross margin rising to 87.6% from 83.3% in the same period last year[176]. - Revenue increased by 6.2million,or82.06.2 million, or 82.0%, for the six months ended June 30, 2024, compared to the same period in 2023, primarily due to increased sales of TriNav[188]. - Gross profit increased by 5.8 million, or 93.7%, for the six months ended June 30, 2024, with gross margin percentage rising to 86.4% from 81.1%[188]. - The net loss attributable to common stockholders was 5.1millionforthethreemonthsendedJune30,2024,comparedtoanetlossof5.1 million for the three months ended June 30, 2024, compared to a net loss of 15.996 million in the same period of 2023[173]. - The company incurred net losses of 17.6 million for the six months ended June 30, 2024, and expects to continue incurring losses due to ongoing investments in R&D and marketing[195]. Research and Development - The DELIVER program aims to evaluate the TriNav system across complex patient populations, with the first clinical study named "PROTECT" focusing on thyroid disease[154][155]. - TriSalus is currently in Phase 1 human trials for nelitolimod, with no guarantee of favorable data or FDA approval[144]. - R&D expenses decreased by 2.2 million, or 32.2%, for the three months ended June 30, 2024, mainly due to reduced clinical trial expenses related to nelitolimod[178]. - R&D expenses decreased by 2.0million,or15.82.0 million, or 15.8%, primarily due to a reduction in clinical trial expenses related to nelitolimod[189]. Capital and Financing - TriSalus reported a total consideration of 220.0 million for the Business Combination, payable in approximately 22,000,000 shares of MTAC common stock[142]. - 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 borrowed on April 30, 2024[146][147]. - The company raised 6.7millionfromthesaleof750,000sharesofcommonstockundertheSEPAduringthesixmonthsendedJune30,2024[196].Thecompanyanticipatesneedingadditionalcapitaltofundoperationsandexecuteitslongtermbusinessstrategy,withsubstantialdoubtregardingitsabilitytocontinueasagoingconcernasofJune30,2024[206].ExpensesSalesandmarketingexpensesincreasedby6.7 million from the sale of 750,000 shares of common stock under the SEPA during the six months ended June 30, 2024[196]. - The company anticipates needing additional capital to fund operations and execute its long-term business strategy, with substantial doubt regarding its ability to continue as a going concern as of June 30, 2024[206]. Expenses - Sales and marketing expenses increased by 2.5 million, or 71.9%, for the three months ended June 30, 2024, driven by higher payroll and travel expenses due to increased headcount[179]. - General and administrative expenses decreased by 0.9million,or19.20.9 million, or 19.2%, for the three months ended June 30, 2024, primarily due to prior period legal and consulting expenses not repeated this year[180]. - Sales and marketing expenses increased by 6.0 million, or 88.3%, driven by higher payroll and travel expenses due to increased headcount[189]. Liabilities and Obligations - As of June 30, 2024, the company has lease obligations totaling 1.5millionforitsprincipaladministrativeandproductionfacilityandotherofficespaces[207].ThecompanyhaspaidDynavax1.5 million for its principal administrative and production facility and other office spaces[207]. - The company has paid Dynavax 12 million as of June 30, 2024, with potential additional payments of up to 158millionuponachievingcertaindevelopmentandregulatorymilestonesfornelitolimod[208].Subjecttomarketingapprovalfornelitolimod,thecompanymayalsopayupto158 million upon achieving certain development and regulatory milestones for nelitolimod[208]. - Subject to marketing approval for nelitolimod, the company may also pay up to 80 million upon achieving certain commercial milestones[208]. - The Dynavax Agreement includes low double-digit royalties based on future net sales of products containing nelitolimod, with potential reductions of up to 50% under certain circumstances[208]. Other Financial Information - The expiration of the TPT payment program on December 31, 2023, may impact TriNav sales and revenue generation[144]. - The company has yet to generate sufficient revenues to drive positive cash flows from operations[141]. - Interest income increased by 0.1million,or169.40.1 million, or 169.4%, for the three months ended June 30, 2024, attributed to additional interest from investments in short-term money market funds[181]. - Interest expense increased by 0.9 million for the three months ended June 30, 2024, due to interest incurred on the OrbiMed loan[182]. - The change in fair value of SEPA, warrant, and revenue base redemption liabilities resulted in a loss of 9.0millionforthethreemonthsendedJune30,2024,comparedtoagainof9.0 million for the three months ended June 30, 2024, compared to a gain of 1.1 million in the same period last year[184]. - The change in fair value of contingent earnout liability resulted in a gain of 13.7millionforthethreemonthsendedJune30,2024,duetothelowermarketpriceoftheunderlyingcommonstock[185].Againof13.7 million for the three months ended June 30, 2024, due to the lower market price of the underlying common stock[185]. - A gain of 9.7 million was recorded for the change in fair value of earnout liabilities for the six months ended June 30, 2024, due to a lower market price of the underlying common stock[193]. - There are no off-balance sheet financing arrangements or relationships with unconsolidated entities as of the reporting period[209]. - There have been no significant changes in critical accounting policies during the six months ended June 30, 2024, compared to the previous year[210].