Financial Data and Key Metrics Changes - TriSalus achieved $29.4 million in net sales for 2024, reflecting a 59.4% growth over 2023, marking it as one of the fastest-growing med tech companies [12][27] - Revenue for Q4 2024 reached $8.3 million, representing a 44% increase compared to Q4 2023 and a 12% sequential increase from Q3 2024 [27] - Operating losses for Q4 2024 totaled $7.6 million, a decrease from $14.2 million in Q4 2023, with year-to-date losses amounting to $36.2 million compared to $54.5 million in 2023 [32] Business Line Data and Key Metrics Changes - The company reported a 44% growth in Q4 and 59% operational growth for the full year, driven by the success of the TriNav device [11][27] - The number of unique ordering accounts increased by 43% year-over-year, from 199 to 284, with account utilization improving by 10% [13][14] - The launch of new products, including the TriNav LD infusion system and TriGuide guiding catheter, expanded the PEDD portfolio [18] Market Data and Key Metrics Changes - TriSalus captured 9% of the liver, TACE, and TARE procedures market in 2024, with 103 new hospital accounts opened [28] - The company reported a robust gross margin profile of 85% in Q4 2024, down from 90% in Q4 2023, but maintained an overall gross margin of 86% for the full year [29] Company Strategy and Development Direction - The company is focusing on expanding its PEDD technology into new clinical applications while reducing R&D expenses to achieve EBITDA positivity by mid-2025 [10][11] - Strategic partnerships are being sought to advance the nelitolimod program, particularly in uveal melanoma liver metastases [19] - The company aims to deepen penetration in the complex liver embolization market and enhance health economic and outcome research data [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving over 50% revenue growth in 2025, alongside positive EBITDA and cash flow in the second half of the year [22][23] - The company acknowledged the challenges posed by the economic environment but emphasized strong commercial momentum and a clear path to growth [10][11] Other Important Information - TriSalus secured up to $50 million in debt financing from OrbiMed to support growth initiatives, with $35 million accessed to date [20] - The company filed a Form 12b-25 notification of late filing with the SEC due to errors in stock-based compensation and R&D expense timing [25][26] Q&A Session Summary Question: Uptake of TriNav large vessels in TACE and TARE procedures - Management noted increased use in TARE more than TACE, particularly for larger vessel applications [37][39] Question: Current mapping with TARE and new CMS code impact - The new CMS code allows for mapping and treatment in Medicare patients, opening up about 25% of the market previously not accessible [46][72] Question: Insights on PERIO-03 data - The Phase I study is focused on safety and technology success, with results expected mid-2025 [50][52] Question: Guidance for Q1 and year cadence - Management indicated that while growth may not be uniform, they remain optimistic about achieving the 50% growth target for the year [61][98] Question: Account openings and utilization strategy - The company is shifting focus from opening new accounts to driving utilization in existing accounts, with a balanced approach moving forward [65][66] Question: Mapping attachment rate in commercial cases - Management believes the mapping attachment rate is close to one-to-one in commercial cases, emphasizing better outcomes with the same technology [81][82] Question: Next steps for pancreatic trials - A Phase II or III trial is likely, with potential for partnership, pending data from ongoing studies [88] Question: Status of 10-K filing delay - The audit is ongoing, and management is committed to transparency regarding any changes in financial results [91][92]

Core Insights - TriSalus Life Sciences, Inc. reported a quarterly loss of $0.35 per share, consistent with the Zacks Consensus Estimate, and an improvement from a loss of $1.56 per share a year ago [1] - The company generated revenues of $8.26 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 1.24% and up from $5.72 million year-over-year [2] - The stock has increased approximately 11.4% since the beginning of the year, contrasting with a -2.9% decline in the S&P 500 [3] Financial Performance - The company has not surpassed consensus EPS estimates over the last four quarters [1] - Current consensus EPS estimate for the upcoming quarter is -$0.22 on revenues of $9.4 million, and for the current fiscal year, it is -$0.60 on revenues of $44.55 million [7] Industry Context - The Medical - Products industry, to which TriSalus belongs, is currently ranked in the bottom 31% of over 250 Zacks industries, indicating potential challenges ahead [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact investor sentiment [5] Future Outlook - The sustainability of the stock's price movement will largely depend on management's commentary during the earnings call [3] - The estimate revisions trend for TriSalus is mixed, resulting in a Zacks Rank 3 (Hold), suggesting the stock is expected to perform in line with the market in the near future [6]

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].

FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TRISALUS LIFE SCIENCES, INC. Table of Contents As filed with the U.S. Securities and Exchange Commission on June 14, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Exact name of registrant as specified in its charter) | Delaware | 3841 | 85-3009869 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or organization) | Cl ...

Table of Contents As filed with the U.S. Securities and Exchange Commission on June 14, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 TRISALUS LIFE SCIENCES, INC. (Exact name of registrant as specified in its charter) | Delaware | 3841 | 85-3009869 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or organization) | Cl ...

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].