Financial Results Announcement - TriSalus Life Sciences, Inc. announced preliminary unaudited financial results for the year and quarter ended December 31, 2024 [4] - The financial results were disclosed in a press release dated January 23, 2025, attached as Exhibit 99.1 to the Form 8-K [4] Form 8-K Filing Details - The information in Item 2.02 of the Form 8-K is furnished and not deemed "filed" under the Securities Exchange Act of 1934 [5] - The press release is incorporated by reference into the Form 8-K [4] Signatory Information - The report was signed by James Young, Chief Financial Officer of TriSalus Life Sciences, Inc., on January 23, 2025 [9]

Core Insights - The article emphasizes the importance of understanding the science behind biotech investments and the potential pitfalls associated with them [2]. Group 1 - The author has a PhD in biochemistry and extensive experience analyzing clinical trials and biotech companies, highlighting the need for informed investment decisions in this sector [2]. - The mission is to educate investors on the complexities of biotech businesses to prevent losses from uninformed decisions [2]. Group 2 - The article does not provide specific investment recommendations or advice, indicating a focus on education rather than direct investment guidance [3]. - It clarifies that past performance is not indicative of future results, reinforcing the need for due diligence in investment choices [3].

Financial Data and Key Metrics Changes - TriSalus reported total revenue of $7.3 million for Q3 2024, reflecting a 42% growth compared to the same period in 2023 [6][44] - Year-to-date revenue stands at $21.2 million, reflecting a 66% growth compared to the first nine months of the previous year [45] - The company maintained a gross margin of 86%, consistent with year-to-date margins and up from 84% for the same period in 2023 [47] - Operating losses for Q3 were negative $8.7 million, an improvement from $18.8 million in Q3 2023 [51] Business Line Data and Key Metrics Changes - The company added 42 net new hospital accounts in Q3, with utilization rising to 15.3 units per account, up from 13.5 units per account in Q3 2023 [45] - The launch of TriNav Large and TriGuide Catheter is underway, expanding the product portfolio to address embolization challenges for complex patients [11] Market Data and Key Metrics Changes - The addressable market for TriNav technology is now over $1 billion, with an incremental market opportunity of $400 million from the new procedure for multinodular goiters [20][19] - The company expects to have approximately 50 commercial personnel by the end of the year to establish comprehensive coverage of high procedure markets [7] Company Strategy and Development Direction - TriSalus aims for sustained growth of 50% annually, driven by expanding market penetration and innovative product launches [5][41] - The company plans to become EBITDA positive in 2025, focusing on revenue growth and operational discipline [40][53] - The DELIVER clinical program is designed to demonstrate enhanced efficacy and safety across a broad spectrum of complex patients [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving over 50% revenue growth in 2025, supported by the successful rollout of TriNav Large and TriNav 2.0 [57] - The company is actively exploring strategic partnerships to advance the nelitolimod program, particularly for uveal melanoma liver metastases [35] Other Important Information - The company plans to draw $10 million from the OrbiMed debt facility early in Q1 2025 to sustain operations through 2025 [52] - The company is submitting for a Category 3 reimbursement code in February 2025, with expectations for approval in mid-2025 [64] Q&A Session Summary Question: Guidance for 2025 and assumptions - Management indicated that the sales force is primarily targeted in the taste and tear market, with early usage in other areas being minimal [60] Question: Advancing nelitolimod and partnership plans - Management stated that they are open to partnerships for uveal melanoma but will not pursue formal programs for other indications at this time [62] Question: Utilization and growth expectations for 2025 - Management expects average utilization to increase to 17.5 units per account, with significant growth from new accounts [67] Question: Multinodular goiters treatment paradigm - Management highlighted the risks associated with surgery and the advantages of their technology in treating multinodular goiters [70][72] Question: 2024 guidance and monthly cadence - Management noted unusual monthly utilization patterns, with a significant increase in September compared to previous months [78] Question: Cash burn and expense reductions - Management explained that cash burn is expected to decrease significantly due to reduced clinical costs and administrative expenses [82] Question: Efficacy of nelitolimod in pancreatic trials - Management is analyzing extensive tissue samples to assess the efficacy of nelitolimod and will provide updates in mid-2025 [85] Question: Competitive landscape for TriNav - Management expressed confidence in their unique technology and noted a lack of direct competitors in the liver and pancreatic markets [90][91]

Financial Performance - Revenue increased by $2.8 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 $6.2 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 $5.1 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 $2.0 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 $50.0 million in senior secured term debt, with an initial commitment of $25.0 million borrowed on April 30, 2024[146][147]. - The company raised $6.7 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 $0.9 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 $1.5 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 $158 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 $0.1 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 $9.0 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 $13.7 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].

Core Viewpoint - TriSalus Life Sciences, Inc. (TLSI) is a device manufacturer focused on organ-targeted therapy delivery mechanisms, with ongoing efforts to develop its own drug to complement its devices, presenting a potential investment opportunity as the market cap has declined significantly [1][13]. Pipeline Updates - TLSI's platform aims to improve tumor uptake of chemotherapy agents in organ-restricted cancers, particularly liver and pancreatic cancers, with optimism surrounding its use in liver metastases from uveal melanoma [2]. - The company is developing nelitolimod (formerly SD-101), a TLR9 activator, which is being evaluated in various solid tumors, including liver metastases and primary liver cancers [3]. Clinical Data - At the Annual Meeting of the Society of Interventional Radiology, the PERIO-03 study demonstrated the feasibility of delivering nelitolimod via pancreatic retrograde venous infusion in 5 patients without immediate complications [4]. - The ASCO Annual Meeting presented more promising data from the PERIO-02 study, where nelitolimod achieved disease control in all 3 patients treated, with no safety concerns noted across 23 patients [5]. Financial Overview - As of the latest quarterly filing, TLSI reported $13.2 million in current assets, including $4.0 million in cash, with a net loss of $13.2 million after operational expenses of $11.7 million [7]. - The company secured $50 million in financing from OrbiMed, extending its cash runway to just over one year, with an additional potential $25 million based on revenue targets [8]. Strengths and Risks - TLSI has seen rapid sales growth from its approved devices, which supports ongoing drug development efforts and provides some financial stability [9]. - Early clinical data for nelitolimod is encouraging, with no major safety concerns reported, although caution is advised due to the small patient cohorts [10]. - Despite securing financing, TLSI's cash runway remains a concern, with quarterly sales doubling year-over-year but still facing significant cash burn [11][12]. Bottom Line Summary - TLSI's market cap has dropped to around $150 million, making it appear more attractive given its two marketed devices generating growing sales, although cash concerns persist [13].

Financial Data and Key Metrics Changes - Company reported a remarkable 116% growth in revenues, reaching $6.5 million, driven solely by the success of the TriNav device in the U.S. This represents the highest quarterly sales in the company’s history [9][15]. - Gross margin improved to 85% in Q1 2024, up from 78% in Q1 2023, attributed to increased factory volumes and operational efficiencies [17][25]. - Operating losses for Q1 2024 totaled $11.7 million, compared to $10.1 million in Q1 2023, primarily due to higher operating expenses in sales and marketing, R&D, and general administrative expenses [37]. Business Line Data and Key Metrics Changes - The growth in revenue was entirely from the sale of TriNav, with the company capturing 32 net new hospital accounts, exceeding internal projections due to pent-up demand [15][16]. - Account utilization increased to 14.5 units per account compared to 11.2 units in Q1 2023, indicating stronger adoption of the TriNav device [16]. Market Data and Key Metrics Changes - The company has achieved a compound annualized growth rate of approximately 50% since the launch of the TriNav product in 2020, with expectations for continued growth over 50% in 2024 [26]. Company Strategy and Development Direction - The company is positioning TriNav to become the standard-of-care for complex patients and is implementing educational and reimbursement support programs to facilitate adoption [12]. - The launch of TriNav Large is anticipated in the second half of the year, with ongoing clinical trials for nelitolimod expected to yield promising results [12][13]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving over 50% top-line revenue growth and advancing the pipeline, supported by recent positive developments in reimbursement and robust clinical data [14]. - The company is focused on pursuing indications with low competitive environments and significant treatment effects, with a comprehensive evaluation of clinical data expected in the third quarter [27]. Other Important Information - The company closed a debt financing facility in April, borrowing $25 million with an additional $25 million available, which is expected to provide sufficient runway to fund operations through the end of 2025 [38]. - General and administrative expenses increased by 30% compared to Q1 2023, primarily due to costs associated with becoming a public company [20]. Q&A Session Summary Question: Upcoming data readouts for nelitolimod and their impact on future decisions - Management is waiting for recently enrolled patients to reach the six-month mark for a comprehensive evaluation, with plans to pursue indications based on competitive environment and treatment effect [27]. Question: Preparation efforts for the commercial launch of TriNav Large - The company has conducted extensive market evaluations and validated the need for a larger size of TriNav, with plans to launch in the fourth quarter [34][42].

Financial Performance - TriSalus Life Sciences, Inc. reported a revenue of $3.1 million from the sale of 350,000 shares of common stock under the SEPA during the three months ended March 31, 2024[147]. - Revenue for the three months ended March 31, 2024, increased by $3.5 million or 116.4% compared to the same period in 2023, driven by higher sales of the TriNav product[169]. - Gross profit rose by $3.2 million or 136.3%, with gross margin improving to 85.0% from 77.8% due to increased manufacturing efficiencies[171]. - The net loss available to common stockholders for the three months ended March 31, 2024, was $13.2 million, compared to a net loss of $8.3 million in the same period of 2023[180]. - Cash and cash equivalents were approximately $4.0 million as of March 31, 2024, with net cash used in operating activities amounting to $10.9 million[180][183]. - Interest income increased by $0.1 million or 162.9% for the three months ended March 31, 2024, due to investments in short-term money market funds[176]. - Net cash provided by financing activities decreased to $3.1 million in Q1 2024 from $7.9 million in Q1 2023, reflecting a significant reduction in capital raised[183][187]. Capital and Funding - The company raised $3.6 million from the sale of 400,000 shares of common stock under the SEPA in April 2024[147]. - The company anticipates needing to raise additional capital to fund operations and execute its long-term business strategy, including potential commercialization expenses[180][190]. - The company may need to raise funds through securities offerings, debt financings, collaborations, or licensing arrangements, which may not be available on favorable terms[194]. - The company has a Credit Agreement with OrbiMed providing for up to $50.0 million in senior secured term debt, with an initial commitment of $25.0 million available on the closing date[149]. - Future capital requirements will depend on factors such as the success of TriNav commercialization, regulatory approval costs for nelitolimod, and the ability to maintain adequate reimbursement for TriNav[191]. - The company has paid Dynavax $12 million as of March 31, 2024, and may owe up to an additional $158 million upon achieving certain development and regulatory milestones for nelitolimod[198]. - Upon obtaining marketing approval for nelitolimod, the company will be required to pay up to $80 million upon achieving certain commercial milestones once sales begin[198]. Research and Development - The company expects R&D expenses to increase significantly as it advances nelitolimod through clinical development[159]. - The company is currently in Phase 1 human trials for nelitolimod, which aims to treat liver and pancreatic cancers[149]. - The company has transformed from solely selling infusion systems to marketing medical devices alongside pharmaceutical drugs[143]. Operational Challenges - Operating expenses increased significantly, with R&D expenses rising by $0.2 million (3.8%), sales and marketing expenses up by $3.4 million (105.8%), and general and administrative expenses increasing by $1.1 million (30.3%) compared to the prior year[172][174][175]. - There is substantial doubt regarding the company's ability to continue as a going concern as of March 31, 2024, due to reliance on generating sufficient cash flows or obtaining additional capital[196]. - The company is subject to affirmative and restrictive covenants under its Credit Agreement, which may limit its ability to incur additional debt or make capital expenditures[192]. Regulatory and Market Developments - The company anticipates submitting a New Drug Approval (NDA) request for nelitolimod to the FDA no sooner than 2025, with potential commercial sales beginning in 2027[143]. - The TriNav Infusion System received a permanent New Technology HCPCS code effective January 1, 2024, which may facilitate reimbursement for the device[142]. - A loss of $4.0 million was recorded due to changes in the fair value of earnout liabilities, attributed to an increase in the market price of the underlying common stock[178].

Financial Performance - Reported revenues of $6.5 million in Q1 2024, representing a 116% increase compared to Q1 2023[7] - Gross margin improved to 85% in Q1 2024, up from 78% in Q1 2023, due to increased factory volumes and operational efficiency[9] - Operating losses were $11.7 million in Q1 2024, compared to $10.1 million in Q1 2023, driven by increased investments in sales, marketing, and R&D[10] - Net losses available to common stockholders were $13.2 million in Q1 2024, compared to $8.3 million in Q1 2023[11] - Full-year sales growth is expected to exceed 50%[7] Financing and Cash Position - Secured up to $50 million in debt financing with OrbiMed to support growth initiatives for the TriNav® Infusion System[4] - Cash and cash equivalents were $3.97 million as of March 31, 2024, down from $11.78 million at the end of 2023[21] - The company expects sufficient cash runway to fund operations through the end of 2025, assuming revenue targets are met[5] Corporate Governance - The company appointed Liselotte Hyveled to its Board of Directors, bringing over two decades of experience in pharmaceutical innovation[6] Shareholder Information - The weighted average common shares outstanding increased to 23,323,045 in Q1 2024 from 16,166,581 in Q1 2023[12]

Revenue and Profitability - Revenue for the year ended December 31, 2023, was $18,511,000, representing a 49% increase from $12,398,000 in 2022[640] - Gross profit increased to $15,906,000 in 2023, up from $10,140,000 in 2022, reflecting a gross margin improvement[640] - The net loss attributable to common stockholders for 2023 was $63,277,000, compared to a loss of $50,016,000 in 2022, highlighting ongoing financial challenges[640] - The company reported a loss from operations of $54,150,000 in 2023, compared to a loss of $36,439,000 in 2022, reflecting increased operational costs[640] - Net loss for 2023 was $59,038, compared to a net loss of $47,187 in 2022, representing a 25.5% increase in losses year-over-year[645] Expenses and Investments - Research and development expenses rose to $29,510,000 in 2023, compared to $21,358,000 in 2022, indicating a focus on innovation[640] - The company reported a significant increase in share-based compensation expense, rising to $1,402 in 2023 from $368 in 2022, a 280.4% increase[645] - Advertising expenses for the years ended December 31, 2023 and 2022 were $1.346 million and $2.201 million, respectively[681] Financial Position - Total assets increased to $25,725,000 in 2023 from $21,995,000 in 2022, showing growth in the company's financial position[638] - Cash and cash equivalents at year-end 2023 were $11,777,000, up from $9,414,000 in 2022, indicating improved liquidity[638] - Total liabilities increased significantly to $51,663,000 in 2023 from $34,319,000 in 2022, raising concerns about financial leverage[638] - The company has an accumulated deficit of $248,377 as of December 31, 2023, indicating ongoing financial challenges[653] Cash Flow and Financing - Cash flows from operating activities resulted in a net cash used of $50,045 in 2023, up from $32,313 in 2022, indicating a 54.8% increase in cash outflow[645] - Management estimates that existing cash and cash equivalents will be insufficient to fund projected liquidity requirements for the next 12 months without additional financing[653] - The company has indicated a need to raise additional equity or debt to fund operations, raising substantial doubt about its ability to continue as a going concern[632] - The company raised $36,854 in cash from the Business Combination, contributing to a total of $164,364 raised from preferred stock since inception[651] Business Combination and Shareholder Equity - The business combination with TriSalus Life Sciences was completed on August 10, 2023, with proceeds totaling $42,854, including $40,150 from PIPE Financing[694][697] - Following the business combination, there were 26,316,681 shares of common stock outstanding and options/RSUs for 2,816,224 shares[699] - The company issued 4,015,002 shares of Series A Convertible Preferred Stock for $40,150, with an original issue price of $10.00 and cumulative dividends accruing at a rate of 8.00% per annum[755] - The total convertible preferred stock decreased from $164,006 as of December 31, 2022, to $0 as of December 31, 2023, due to conversions and retirements[768] Stock and Warrant Information - The total number of warrants outstanding decreased from 15,819,000 in 2022 to 14,215,112 in 2023, a reduction of approximately 10.1%[730] - The fair value of the Series B-3 Warrants as of August 10, 2023, was estimated at $9.31 per share, based on an enterprise value of $220,000 allocated to all outstanding shares[774] - The Company repurchased 51,493 Public Warrants for a total of $20 under a warrant repurchase program authorized for up to $4,000[739] Lease and Tax Information - Total lease liabilities as of December 31, 2023, amounted to $1,431 for operating leases and $164 for finance leases[804] - The total lease expense for the year ended December 31, 2023, was $489, compared to $463 in 2022[802] - The Company has established a valuation allowance equal to 100% of net deferred tax assets due to the lack of historical taxable income[741] Future Plans and Strategic Initiatives - The company is undergoing a strategic transformation to market its medical devices alongside pharmaceutical drugs, which will increase operating expenses in the short term[653] - The Employee Stock Purchase Plan (ESPP) will become active in 2024, with 1,396,252 shares reserved for issuance and an automatic annual increase of 2% of the total shares of Fully Diluted Common Stock[797]

Financial Data and Key Metrics Changes - TriSalus achieved $5.7 million in revenue for Q4 2023, representing a 77% increase compared to Q4 2022 and a 10% sequential increase from Q3 2023 [61] - Full year revenues reached $18.5 million in 2023, a 49% increase from 2022 [62] - Gross margin for Q4 2023 was 90%, up from 75% in Q4 2022, and full year gross margin was 86%, compared to 82% in 2022 [45] - Operating losses for Q4 2023 totaled $14.1 million, compared to $11.4 million in Q4 2022, with year-to-date losses amounting to $54.2 million in 2023, up from $36.4 million in 2022 [47][48] Business Line Data and Key Metrics Changes - The company reported a 49% operational growth for the year, driven by the adoption of the TriNav device in new accounts and increased utilization in existing accounts [14][62] - The sales team expanded from 10 representatives at the beginning of 2023 to 28 by the end of Q4 2023, along with the addition of seven clinical specialists [63] Market Data and Key Metrics Changes - TriSalus captured 7% market share in liver TACE and TARE procedures in 2023, with expectations for growth exceeding 50% in 2024 [38] - A health, economic, and outcome research study covering 300 million patient data sets demonstrated that TriNav patients achieved comparable clinical results to those with lower disease burdens [20][25] Company Strategy and Development Direction - The company aims to position TriNav as the standard-of-care for complex patients requiring liver embolization, focusing on educational initiatives and comprehensive reimbursement support [29] - TriSalus plans to advance its pipeline with nelitolimod and is investigating its use in combination with systemic checkpoint inhibitors [30][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in TriSalus's potential for breakout growth in 2024 due to permanent reimbursement and robust clinical evidence for TriNav [22] - The company anticipates a decrease in clinical costs in 2024 as it completes patient follow-up and analyzes trial data [64] Other Important Information - TriSalus filed a Form 12b-25 Notification of Late Filing with the SEC due to data errors related to non-cash stock compensation expense [8][9] - The company raised $61 million in 2023, including a $41 million PIPE to support going public, and ended the year with $11.8 million in cash and cash equivalents [48] Q&A Session Summary Question: Inclusion of clinical specialists for TriNav sales - The company currently has seven clinical specialists who support sales representatives in training physicians and expanding adoption [51] Question: Next steps for pancreatic work to larger Phase 2 trial - The company is completing enrollment in the Phase 1 single agent nelitolimod experience to establish safety and feasibility before moving to Phase 1b [70][71]