PresentationGood afternoon, and welcome to the TriSalus Life Sciences Virtual KOL event. [Operator Instructions] As a reminder, this call is being recorded, and a replay will be made available on the TriSalus website following the conclusion of the event. I'd now like to turn the call over to Mary Szela, Chief Executive Officer and President at TriSalus Life Sciences. Please go ahead, Mary.Mary SzelaCEO, President & Director Thank you, and thank you all for joining today. I'm really excited to kick off this ...

Summary of Trisalus Life Sciences Conference Call Company Overview - **Company**: Trisalus Life Sciences (NasdaqGM: TLSI) - **Focus**: Improving outcomes for patients with solid tumors in the liver, pancreas, and other areas through innovative delivery technologies [2][3] Core Technology and Market Opportunity - **Technology**: A catheter-based system that modulates pressure and flow to enhance drug delivery directly into tumors, minimizing off-target effects [3][4] - **Market Size**: The company operates in a market opportunity of approximately $500 million, with less than 10% market share currently [3][4] - **Growth Potential**: Rapid growth anticipated due to the versatility of the technology for various embolization applications [4] Innovations in Treatment - **Thyroid Artery Embolization**: A new approach developed by Dr. Juan Camacho, aimed at treating multinodular goiter as a minimally invasive alternative to surgery [10][12] - **Patient Outcomes**: The technology has shown a 50% reduction in post-procedure readmissions due to fewer complications [8][9] Multinodular Goiter Insights - **Prevalence**: Approximately 12% of the adult population worldwide has multinodular goiter, with a significant number undergoing thyroidectomies annually [17][18] - **Surgical Risks**: Many surgeries are performed by general surgeons, leading to disparities in outcomes compared to specialized surgeons [18][19] - **Symptoms and Complications**: Patients often experience significant morbidity, including hyperthyroidism and compressive symptoms [21][23] Treatment Paradigms - **Minimally Invasive Options**: Options include radioactive iodine, percutaneous ethanol injection, ablation, and thyroid artery embolization [25][31] - **Volume Considerations**: Larger nodules (>20 mL) are more effectively treated with thyroid artery embolization due to high recurrence rates with other methods [27][28] Clinical Evidence and Results - **Efficacy of Embolization**: Studies indicate that thyroid artery embolization can reduce thyroid volume by approximately 50% and improve hormone levels without causing hypothyroidism [36][37] - **Quality of Life Improvements**: Significant improvements in quality of life reported post-procedure, with a high euthyroid conversion rate in patients with hyperthyroidism [38][39] Future Directions - **Research and Guidelines**: Ongoing efforts to build robust clinical data and establish guidelines for patient selection and treatment protocols [54][56] - **Awareness and Training**: Emphasis on increasing awareness of the procedure among patients and healthcare providers, and ensuring proper training for practitioners [64][65] Conclusion - **Emerging Treatment**: Pressure-enabled thyroid artery embolization presents a promising alternative for patients with large goiters, particularly when surgery poses high risks [52][53] - **Multidisciplinary Approach**: Collaboration among various specialties is crucial for optimizing patient care and integrating this technology into standard practice [64][65]

Summary of Trisalus Life Sciences FY Conference Call Company Overview - **Company**: Trisalus Life Sciences (NasdaqGM: TLSI) - **Industry**: Oncology-focused medical technology - **Market Opportunity**: $2.5 billion market in liver embolization procedures, currently growing at over 50% per year [2][24] Core Technology and Innovations - **Technology**: Catheter-based system that enhances drug delivery to tumors while minimizing exposure to normal tissue - **Patent Portfolio**: Over 100 patents, with 20-25 patents filed annually, focusing on pressure modulation for optimal tumor perfusion [3][2] - **Drug Delivery Efficiency**: Achieves 50%-500% more drug delivery to tumors compared to traditional methods [7][8] Clinical and Economic Impact - **Patient Outcomes**: Improved overall survival rates and reduced complications due to targeted drug delivery [8][10] - **Cost Savings**: CMS saves approximately $8,000 per procedure due to reduced hospital readmissions [10][11] - **Reimbursement**: Favorable reimbursement landscape with a proprietary embolization code, enhancing hospital revenue [13][10] Product Portfolio and Market Penetration - **Current Devices**: Two devices launched in 2020 and 2021, with plans to introduce two additional sizes to cater to various vascular anatomies [11][12] - **Market Share**: Currently holds a 9% share in the liver embolization market, with significant growth potential [14] - **Expansion into Other Applications**: Technology is being adapted for uterine fibroids, thyroid nodules, and pancreatic treatments, among others [15][19][20] Future Growth Opportunities - **New Applications**: Exploring embolization procedures for osteoarthritis and other orthopedic conditions, which could significantly change treatment paradigms [22][23] - **Collaborations**: Partnerships with other drug companies to enhance drug delivery systems and improve treatment outcomes [20][21] - **Market Strategy**: Targeting 400 hospitals and 1,000 doctors, focusing on a concentrated market approach [13][14] Financial Outlook - **Growth Guidance**: Current year growth projected at 50%, with future guidance under review [28] - **Cost Management**: Focus on reducing R&D and G&A expenses while maintaining positive Adjusted EBITDA by mid-year [29][30] - **Revenue Performance**: Achieved approximately $12 million in revenue last quarter, with gross margins around 85% [30][31] Additional Insights - **Unique Selling Proposition**: The technology's ability to modulate pressure and flow allows for better treatment outcomes and minimizes complications [6][7] - **Regulatory Strategy**: Plans to gather clinical data to support inclusion in treatment guidelines, which could drive adoption [26][27] This summary encapsulates the key points discussed during the Trisalus Life Sciences FY Conference Call, highlighting the company's innovative technology, market opportunities, and financial outlook.

Summary of TriSalus Life Sciences Conference Call Company Overview - **Company**: TriSalus Life Sciences (NasdaqGM: TLSI) - **Industry**: Oncology medical technology - **Technology**: Pressure-enabled drug delivery system designed to enhance drug delivery to tumors while minimizing exposure to normal tissues [2][6] Core Points and Arguments - **Market Opportunity**: The microcatheter market is valued at $2.5 billion, with TriSalus focusing primarily on liver applications, holding less than 10% market share, indicating significant growth potential [2][8] - **Growth Rate**: The company has experienced a growth rate of 50% annually with an 85% gross margin [2][8] - **Clinical Benefits**: The technology has shown to increase drug delivery to tumors by 40%-500%, leading to improved patient outcomes and reduced hospital readmission rates by 50% [5][7] - **Reimbursement**: TriSalus has secured favorable reimbursement codes from CMS, which are permanent and unique to their technology, enhancing economic viability for hospitals [7][8][31] - **Device Variants**: The company offers multiple device configurations (TriNav, TriNav Large, TriNav Flex) tailored to different patient anatomies [5][8] Additional Applications - **Uterine Fibroids**: The technology has been adapted for treating uterine fibroids, providing a less invasive option compared to surgery [9][10] - **Multinodular Goiter**: TriSalus is exploring applications for treating thyroid nodules, which can be accessed via a less invasive route [11][12] - **Pancreatic Cancer**: The company is developing a device for pancreatic cancer treatment, utilizing venous anatomy for drug delivery [13][14] - **Genicular Artery Embolization**: A new application for osteoarthritis treatment is being explored, with promising initial results [15][16] Financial Performance - **Q3 Earnings**: Reported earnings of $11.6 million, with expectations for a strong Q4 due to year-end spending [16][18] - **Operational Expenses**: Targeting $14 million in GAAP operational expenses, with a focus on maintaining sales and marketing efficiency [24][25] - **Sales Strategy**: The focus is on increasing utilization within existing accounts rather than acquiring new accounts, leveraging recent product iterations [20][26] Future Outlook - **Product Launches**: Anticipated launch of new technology in December, aimed at enhancing physician adoption without requiring a switch from existing microcatheters [17][30] - **Clinical Studies**: Ongoing clinical studies to support the efficacy of the technology across various applications, with plans for registry studies to gather robust data [27][29] - **Reimbursement Impact**: The introduction of mapping codes has resulted in a 30% increase in business, highlighting the importance of training hospitals for billing [31][32] Important but Overlooked Content - **Patient-Centric Approach**: The technology not only improves clinical outcomes but also reduces the need for long-term therapies, such as thyroid replacement, which can significantly enhance patient quality of life [12][15] - **Grassroots Adoption**: Many new applications have emerged from physician-led initiatives, indicating a strong grassroots demand for the technology [23][27] - **Cost Savings**: The technology has been shown to reduce overall procedure costs, providing additional financial incentives for hospitals [33]

Financial Performance - TriSalus Life Sciences, Inc. reported a quarterly loss of $0.96 per share, significantly worse than the Zacks Consensus Estimate of a loss of $0.17, representing an earnings surprise of -464.71% [1] - The company posted revenues of $11.57 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 0.79%, and showing an increase from $7.35 million in the same quarter last year [2] - The current consensus EPS estimate for the upcoming quarter is -$0.13 on revenues of $12.88 million, and for the current fiscal year, it is -$0.86 on revenues of $44.69 million [7] Stock Performance - TriSalus Life Sciences, Inc. shares have declined approximately 11.8% since the beginning of the year, contrasting with the S&P 500's gain of 16.5% [3] - The company has not surpassed consensus EPS estimates over the last four quarters, indicating a trend of underperformance [2] Industry Outlook - The Medical - Products industry, to which TriSalus belongs, is currently ranked in the bottom 36% of over 250 Zacks industries, suggesting potential challenges ahead [8] - The performance of TriSalus may be influenced by the overall outlook of the industry, as research indicates that the top 50% of Zacks-ranked industries outperform the bottom 50% by more than 2 to 1 [8]

Financial Data and Key Metrics Changes - Revenues for Q3 2025 were $11.6 million, representing a 57% increase year-over-year and a 3% sequential gain over Q2 2025 [5][16] - Gross margin for the quarter was 84%, down from 86% in the prior year, primarily due to lower manufacturing efficiency associated with newly launched products [17] - Operating loss for the quarter was $9 million, compared to $8.7 million in the prior year, driven by one-time charges related to clinical studies [18] - Cash used in operations was $3.7 million, a significant improvement from $11.2 million in Q3 2024 [19] - Adjusted EBITDA loss improved to $5.4 million from $7.1 million in the prior year [19] Business Line Data and Key Metrics Changes - The commercial organization increased the number of unique ordering accounts by 30% compared to Q3 2024, adding 20 new accounts [16] - The reimbursement use of TriNav technology within the radioembolization market has effectively doubled due to the introduction of a new CMS code [6][7] - The company launched the TriNav Flex infusion system and advanced new clinical applications to expand market opportunities [5][6] Market Data and Key Metrics Changes - The company is experiencing strong commercial momentum in the complex liver embolization market, supported by the new CMS HCPCS code C8004 [6][7] - Early feedback from key accounts indicates strong clinical and economic advantages from the expanded reimbursement, expected to drive adoption into 2026 [7] Company Strategy and Development Direction - The company is focused on expanding its TriNav platform and investing in long-term growth through increased commercial resources and funding for new applications [6][8] - Trisalus aims to leverage its pressure-enabled drug delivery (PEDD) technology across a wide range of solid tumors and interventional treatment approaches [8][15] - The company is also preparing to launch a clinical trial evaluating TriNav and genicular artery embolization (GAE) for knee osteoarthritis [12][43] Management's Comments on Operating Environment and Future Outlook - Management reaffirmed a 50% revenue growth guidance, reflecting confidence in growth momentum and market opportunities [7][21] - The company is excited about the current momentum, especially in Q4, and is focused on maintaining its growth trajectory [21][27] - Management highlighted the potential of GAE as a significant market opportunity, potentially rivaling the liver market [42][43] Other Important Information - The company simplified its capital structure through a successful exchange offer and consent solicitation for preferred stock [6] - Cash and cash equivalents at the end of the quarter were $22.7 million, providing ample liquidity for operations and strategic objectives [19] Q&A Session Summary Question: Insights on 2026 growth expectations - Management is confident about current momentum and maintaining guidance of 50% growth and adjusted EBITDA positivity in the first half of next year [21] Question: Growth in other indications outside liver - The company is investing in new applications, particularly in uterine artery embolization, which is expected to reduce procedural time and pain [22] Question: Gross margin outlook - Management expects an uptick in gross margins in Q4 as manufacturing efficiencies improve [33] Question: Adoption of new products - The TriNav Flex has been well received, with significant adoption in selective treatments and larger territory treatments [38] Question: Utilization trends for accounts launched at different times - Accounts launched 18 months ago continue to improve month over month, with faster ramps for those familiar with the technology [44]

Product Development and Market Expansion - TriSalus reported a significant expansion in its PEDD device portfolio with the launch of the TriNav LV Infusion System and TriGuide Guiding Catheter, aimed at optimizing therapeutic delivery for larger vessels [150]. - The company estimates that the new PROTECT registry study could expand the addressable market by approximately 50,000 procedures, representing an incremental $400 million market opportunity [152]. - TriSalus received a permanent HCPCS code for the TriNav Infusion System effective January 1, 2024, which may enhance reimbursement prospects for hospitals [149]. - The company is actively seeking pharmaceutical partners to advance the development of nelitolimod due to the high costs associated with clinical trials [153]. - TriSalus's innovative technology aims to address high intratumoral pressure and off-target delivery challenges in solid tumor treatments [147]. - The company is focused on transforming treatment paradigms for patients with solid tumors through its integrated delivery technology and investigational therapies [147]. Financial Performance - Revenue increased by $4.2 million, or 57.4%, for the three months ended September 30, 2025, compared to the same period in 2024, primarily due to an increase in TriNav units sold [170]. - Cost of goods sold rose by $0.9 million, or 89.8%, for the three months ended September 30, 2025, attributed to more TriNav units sold [171]. - Gross profit increased by $3.3 million, or 52.2%, for the three months ended September 30, 2025, while gross margin decreased to 83.5% from 86.3% [172]. - Research and development expenses increased by $1.0 million, or 22.7%, for the three months ended September 30, 2025, mainly due to clinical trial expenses related to nelitolimod [174]. - Sales and marketing expenses rose by $0.7 million, or 11.4%, for the three months ended September 30, 2025, driven by increased performance-related compensation [176]. - General and administrative expenses increased by $1.9 million, or 40.9%, for the three months ended September 30, 2025, primarily due to a non-cash stock-based compensation award [177]. - For the nine months ended September 30, 2025, revenue increased by $10.8 million, or 50.9%, compared to the same period in 2024, driven by higher TriNav unit sales [184]. - Cost of goods sold for the nine months ended September 30, 2025, increased by $2.3 million, or 80.2%, due to more TriNav units sold [185]. - Net loss attributable to common stockholders for the nine months ended September 30, 2025, was $59.9 million, compared to $22.3 million in the same period of 2024, reflecting a significant increase in losses [182]. - Interest expense increased by $2.1 million for the nine months ended September 30, 2025, due to additional funds borrowed under the First Delayed Draw Term Loan [190]. - The company incurred a net loss of $29.5 million for the nine months ended September 30, 2025, compared to a net loss of $19.9 million for the same period in 2024 [196][197]. Cash Flow and Funding - Cash and cash equivalents were approximately $22.7 million as of September 30, 2025, with a minimum cash requirement of $10.0 million, which was later reduced to $5.0 million [194]. - Net cash used in operating activities was $15.5 million for the nine months ended September 30, 2025, a decrease from $35.1 million in the same period of 2024 [195][197]. - The company raised gross proceeds of approximately $22.0 million through a Private Placement on April 30, 2025, and $10.0 million from the First Delayed Draw Term Loan Commitment [194][199]. - Net cash provided by financing activities was $30.5 million for the nine months ended September 30, 2025, compared to $34.9 million in 2024 [199][200]. - The company expects to incur significant expenses related to the commercialization of its product TriNav, which will require substantial additional funding [201][204]. Risks and Concerns - The expiration of the Transitional Pass-Through payment program on December 31, 2023, poses a risk to maintaining current pricing and gross margins for TriNav [154]. - The company is subject to significant risks related to inflation, rising interest rates, and potential disruptions in access to capital, which could impact its liquidity [203][204]. - There is substantial doubt regarding the company's ability to continue as a going concern as of September 30, 2025, due to its reliance on additional capital [208]. - The company has contractual obligations of $2.0 million in lease obligations as of September 30, 2025 [209]. - The company has paid $12.0 million to Dynavax and may owe up to an additional $158.0 million upon achieving certain milestones related to nelitolimod [210][212].

Revenue and Growth - TriSalus reported $11.6 million in revenue for Q3 2025, a 57% increase year-over-year and a 3% sequential growth from Q2 2025[5] - The company reaffirmed its full-year revenue growth guidance of at least 50%, driven by the increasing market penetration of the TriNav product suite[2] Expenses - Research and Development (R&D) expenses were approximately $5.2 million, up from $4.2 million in Q3 2024, influenced by a one-time charge of $2.1 million related to clinical studies[5] - Sales and Marketing (S&M) expenses increased to approximately $6.8 million in Q3 2025, compared to $6.1 million in the same quarter of the prior year[10] - Stock-based compensation expense for the nine months ended September 30, 2025, was $6,934 million, up from $3,744 million in 2024, an increase of 85.5%[22] Profitability and Loss - The net loss attributable to common stockholders was $41.3 million in Q3 2025, significantly higher than the $3.2 million loss in the same period of 2024, mainly due to the conversion of preferred stock[10] - The basic and diluted loss per share was $0.96 for Q3 2025, compared to $0.12 for the same period in 2024[10] - Net loss for the nine months ended September 30, 2025, was $29,474 million, compared to a net loss of $19,937 million for the same period in 2024, representing a decline of 47.6%[18] - Adjusted EBITDA for the nine months ended September 30, 2025, was $(16,241) million, compared to $(24,290) million for the same period in 2024, showing an improvement of 33.2%[22] Cash and Liquidity - As of September 30, 2025, cash and cash equivalents totaled $22.7 million, providing sufficient runway to reach positive adjusted EBITDA[10] - Cash and cash equivalents at the end of the period were $23,037 million, up from $11,638 million at the end of September 2024, indicating an increase of 97.5%[18] - Cash flows used in operating activities for the nine months ended September 30, 2025, were $(15,528) million, compared to $(35,136) million in 2024, indicating a reduction of 55.8%[18] Assets and Liabilities - Total assets increased to $36,463 million as of September 30, 2025, compared to $23,971 million on December 31, 2024, reflecting a growth of approximately 52.0%[15] - Total liabilities rose to $63,188 million as of September 30, 2025, from $49,865 million on December 31, 2024, marking an increase of 26.6%[15] - Long-term debt increased to $32,764 million as of September 30, 2025, from $22,084 million on December 31, 2024, representing a rise of 48.3%[15] Clinical Trials and Product Development - The company initiated a clinical trial to evaluate genicular artery embolization (GAE) for knee osteoarthritis, a condition affecting over 30 million adults in the U.S.[5] - TriSalus completed three PERIO clinical phase 1 dose escalation studies, with clinical study reports expected for data release in Q4 2025[2] Financing Activities - Proceeds from the issuance of common stock amounted to $22,211 million for the nine months ended September 30, 2025, compared to $12,586 million in the same period of 2024, reflecting a growth of 76.5%[18] - The company reported a cash paid for interest of $2,528 million for the nine months ended September 30, 2025, compared to $1,757 million in 2024, an increase of 43.8%[18]

Core Viewpoint - TriSalus Life Sciences, Inc. reported strong commercial performance in Q3 2025, highlighting its innovative approach in oncology and the integration of novel delivery technology with standard therapies [1] Financial Results - The company announced its financial results for the quarter ended September 30, 2025, indicating a positive trend in revenue generation and operational efficiency [1] Operational Update - TriSalus provided an operational update, emphasizing its investigational immunotherapeutic aimed at transforming treatment for patients with solid tumors, which reflects the company's commitment to advancing cancer care [1]

Core Insights - TriSalus Life Sciences Inc. (NASDAQ:TLSI) is preparing for its quarterly earnings release, focusing on innovative oncology treatments with Wall Street expecting an earnings per share (EPS) of -$0.17 and projected revenue of approximately $11.76 million [1][3] Financial Performance - The company has a negative price-to-earnings (P/E) ratio of -4.67, indicating challenges in profitability [2][4] - TLSI's price-to-sales ratio is about 4.66, suggesting investors are willing to pay $4.66 for every dollar of sales [5] - The enterprise value to sales ratio stands at around 4.86, reflecting the company's valuation relative to its sales [5] - The enterprise value to operating cash flow ratio is approximately -6.17, indicating negative operating cash flow [5] - The earnings yield is about -21.44%, showing negative earnings relative to its share price [6] - The debt-to-equity ratio is approximately -1.73, suggesting more liabilities than equity [6] - The current ratio of around 4.08 indicates a strong ability to cover short-term liabilities with short-term assets [6] Company Activities - TLSI is actively engaging in investor relations, participating in the Canaccord Genuity MedTech, Diagnostics, and Digital Health conference [2][4] - The company is hosting a virtual event on November 12, 2025, to discuss the TriNav Infusion System, emphasizing its commitment to improving treatment outcomes for solid tumors [4]