Company Overview - TriSalus Life Sciences, Inc. focuses on innovative drug delivery technology and immune-oncology therapeutics, particularly for liver and pancreatic cancer [172]. - The company has developed two product lines: Pressure Enabled Drug Delivery (PEDD) infusion systems and the investigational agent SD-101, aimed at enhancing immune response in treating solid tumors [172]. Financial Performance - Revenue for the three months ended September 30, 2023, increased by $1.3 million or 32.4% compared to the same period in 2022, primarily due to an increase in units of TriNav sold [208]. - Gross profit for the three months ended September 30, 2023, increased by $1.4 million or 42.9%, with gross margin rising to 88.7% from 82.1% in the same period last year [210]. - Revenue increased by $3.6 million, or 39.4%, for the nine months ended September 30, 2023, compared to the same period in 2022, primarily due to higher sales volume of TriNav [218]. - Gross profit increased by $3.0 million, or 39.3%, for the nine months ended September 30, 2023, while gross margin slightly decreased from 84.3% to 84.2% [220]. Expenses - R&D expenses increased by $4.6 million or 94.8% for the three months ended September 30, 2023, driven by costs associated with clinical trials for drug candidate SD-101 [211]. - Sales and marketing expenses rose by $1.7 million or 54.8% for the three months ended September 30, 2023, primarily due to increased payroll and travel expenses [213]. - General and administrative expenses increased by $5.5 million or 158.2% for the three months ended September 30, 2023, mainly due to higher professional services costs related to the Business Combination [214]. - R&D expenses rose by $6.8 million, or 44.9%, for the nine months ended September 30, 2023, mainly due to increased spending on clinical trials and manufacturing development [221]. - General and administrative expenses surged by $9.1 million, or 107.7%, for the nine months ended September 30, 2023, largely due to higher professional service fees and increased payroll expenses [225]. Cash Flow and Financing - Net cash used in operating activities was $41.2 million for the nine months ended September 30, 2023, compared to $24.0 million for the same period in 2022 [239]. - Net cash provided by financing activities was $54.6 million for the nine months ended September 30, 2023, primarily from the merger proceeds and issuance of preferred stock [245]. - The company anticipates requiring additional capital in the near term to fund operations, which may not be available on favorable terms or at all [252]. - The company has entered into the Yorkville Purchase Agreement, allowing it to sell up to $30.0 million of shares of Common Stock [252]. Losses and Concerns - The company incurred net losses of $23.5 million for the nine months ended September 30, 2023, and has substantial doubt about its ability to continue as a going concern [231]. - The company may face substantial doubt regarding its ability to continue as a going concern due to insufficient cash flow and liquidity [254]. - The company may need to delay or curtail operations if it cannot secure sufficient capital to capitalize on business opportunities [253]. Business Developments - The company completed a Business Combination on August 10, 2023, with an aggregate consideration of $220 million, resulting in the exchange of approximately 890 million shares of TriSalus common stock for about 22 million shares of MTAC common stock [175][177]. - In October 2022, TriSalus raised approximately $9.8 million through the sale of 706,243 shares of Series B-2 preferred stock at $14.16 per share [179]. - In August 2023, the Board approved a warrant repurchase program with an expenditure of up to $4 million, having repurchased 28,502 Public Warrants for $9.9 thousand by October 31, 2023 [185]. - On October 2, 2023, TriSalus entered into a Standby Equity Purchase Agreement with Yorkville, allowing the sale of up to $30 million of Common Stock during the commitment period [186][187]. Regulatory and Compliance - TriSalus applied for a new technology Ambulatory Payment Classifications code with CMS on June 1, 2023, to ensure continued reimbursement for the TriNav device starting January 1, 2024 [173]. - The company recognizes revenue from TriNav shipments when control of the units has been transferred to the customer, following ASC 606 guidelines [259]. - The company has no off-balance sheet financing arrangements or relationships with unconsolidated entities [257]. Future Outlook - The company expects R&D expenses to increase significantly in future periods as it advances its manufacturing technologies and seeks regulatory approvals for drug candidates [196]. - The company expects to incur significant expenses related to the commercialization of TriNav, including manufacturing, distribution, marketing, and sales costs [249]. - Approximately 12% of the company's R&D costs are headcount-related, with the remainder being external services for pre-clinical and clinical activities [268]. - The company will remain an emerging growth company until the earlier of December 31, 2025, or achieving total annual gross revenue of at least $1.235 billion [276]. - The market value of the company's common equity held by non-affiliates must exceed $700 million to be deemed a "large accelerated filer" under SEC rules [276]. - The company has elected to take advantage of the extended transition period under the JOBS Act, which may affect comparability with other public companies [275]. - Recent accounting pronouncements may impact the company's financial condition and results of operations, as detailed in the quarterly report [277].
TriSalus Life Sciences(TLSI) - 2023 Q3 - Quarterly Report