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 Data and Key Metrics Changes - Trisalis Life Sciences reported net sales of $9.2 million for Q1 2025, representing a 42% increase compared to Q1 2024 and an 11% sequential gain over Q4 2024 [9][23] - The company achieved a gross margin of 84% in Q1 2025, slightly down from 85% in Q1 2024, attributed to decreased factory volumes during a clean room expansion [24] - Operating losses for Q1 2025 totaled $7.3 million, a decrease from $11.7 million in Q1 2024, primarily due to increased sales and reduced R&D expenses [25] - Adjusted EBITDA losses for Q1 2025 were $5.5 million, compared to losses of $10.4 million in Q1 2024 [27] Business Line Data and Key Metrics Changes - The company maintained strong momentum in the liver embolization market, increasing the number of unique ordering accounts by 39% year-over-year, adding 32 new accounts in Q1 2025 [11][12] - The launch of TriNav Large and TriGuide expanded the PEDD technology into larger vessels, supporting deeper penetration in the liver market [15] Market Data and Key Metrics Changes - Trisalis has achieved a market share of 10% in liver taste and tear procedures, reflecting growth driven by the adoption of TriNav in new accounts and increased utilization [23] - The Centers for Medicare and Medicaid Services issued a new HCPCS code C8004, providing coverage for mapping procedures using TriNet, effectively doubling the reimbursable use of the technology [12] Company Strategy and Development Direction - The company is focusing on deepening penetration in the liver embolization market, advancing TriNav Flex and TriNav Large, and generating new health economic and outcome research data [19][20] - A shift to a partnership-focused strategy for nalotolimod is expected to eliminate development expenses while preserving long-term value [9][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving at least 50% revenue growth for 2025, despite not anticipating being EBITDA positive or cash flow positive in the year [20] - The company is optimistic about the momentum built from recent strategic initiatives and the potential for new clinical applications [19][21] Other Important Information - Trisalis raised approximately $22 million in gross proceeds through a private placement, strengthening its balance sheet for future investments [18][27] - The company is implementing an exchange offer to convert preferred shares to common stock, simplifying its capital structure [18] Q&A Session Summary Question: What should be looked for in the PERIO three readout? - Management highlighted the focus on the device's functionality and safety profile, as well as the potential to stimulate the innate environment of pancreatic tumors [36] Question: Is there interest in nalotolimod independently or in conjunction with TriNav? - Management clarified that nalotolimod's optimal delivery is through their technology, and they expect to partner with pharmaceutical companies for combined trials [40] Question: Feedback on TriNav Large and its adoption? - Initial adoption is strong among larger tumors and uterine fibroid embolization, with positive results reported by physicians [46] Question: Impact of clean room expansion on gross margins? - The clean room expansion was completed in March, and gross margins are expected to improve in the upcoming quarters [50] Question: How will the sales force expansion impact growth rates? - The company plans to add sales resources to accelerate growth, with the most significant impact expected in 2026 [55] Question: Feedback on the new mapping code? - Early feedback is favorable, with physicians using the device more consistently due to full reimbursement [58] Question: Commercial organization expansion and account numbers? - The company currently has around 300 accounts and aims to expand its sales force to 60-70 representatives over the next 18 months [79]

Financial Data and Key Metrics Changes - Trisalis Life Sciences reported net sales of $9.2 million for Q1 2025, representing a 42% increase compared to Q1 2024 and an 11% sequential gain over Q4 2024 [8][22] - The company achieved a gross margin of 84% in Q1 2025, slightly down from 85% in Q1 2024, attributed to decreased factory volumes during a clean room expansion [23] - Operating losses for Q1 2025 totaled $7.3 million, a decrease from $11.7 million in Q1 2024, primarily due to increased sales and reduced R&D expenses [24] - Adjusted EBITDA losses for Q1 2025 were $5.5 million, down from $10.4 million in Q1 2024, reflecting improved sales and reduced expenses [25] Business Line Data and Key Metrics Changes - The company maintained strong momentum in the liver embolization market, increasing the number of unique ordering accounts by 39% compared to Q1 2024, adding 32 new accounts [10] - The TriNav device's market share in liver procedures reached 10%, with a compound annual growth rate of approximately 50% since its launch in 2020 [22] Market Data and Key Metrics Changes - The Centers for Medicare and Medicaid Services issued a new HCPCS code C8004, providing coverage for mapping procedures using TriNav, effectively doubling the reimbursable use of the technology [11] - The company is expanding its technology into new clinical settings, including a multicenter registry evaluating PEDD for patients with thyroid nodules [13] Company Strategy and Development Direction - The company is focusing on deepening penetration in the liver embolization market, advancing TriNav technology, and preparing nalotolimod for pharmaceutical partnerships [7][18] - Strategic priorities include driving adoption of PEDD across solid tumors, improving manufacturing and gross margins, and expanding the product portfolio [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving at least 50% revenue growth for 2025, despite not anticipating being EBITDA positive or cash flow positive in the year [19] - The company is entering the rest of 2025 with strong tailwinds and plans to invest in strategic areas to drive long-term value [19][20] Other Important Information - The company raised approximately $22 million in gross proceeds through a private placement, strengthening its balance sheet for further investments [16] - The completion of Phase I trials for nalotolimod allows the company to shift to a partnership-focused strategy, reducing development expenses [15] Q&A Session Summary Question: What should be looked for in the PERIO three readout? - Management highlighted the focus on the device's functionality and safety profile, as well as the potential to stimulate the innate environment of pancreatic tumors [30][34] Question: Is there interest in nalotolimod independently or in conjunction with TriNav? - Management indicated that nalotolimod's performance is optimized through their technology, and they expect to partner with pharmaceutical companies for combined development [35][38] Question: Feedback on TriNav Large and its adoption? - Initial adoption is strong among physicians treating larger tumors, with positive results reported [41][43] Question: Impact of clean room expansion on gross margins? - The clean room expansion was completed in March, and gross margins are expected to improve in the upcoming quarters [45][46] Question: How will the sales force expansion impact growth rates? - The company plans to add sales resources to accelerate growth, with the most significant impact expected in 2026 [50][51] Question: Feedback on the new mapping code? - Early feedback is favorable, with physicians using the device more consistently due to full reimbursement [52][54] Question: What is the current number of accounts and future goals? - The company has around 300 accounts and aims to increase its sales force to cover more hospitals [73][76]

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, compared to losses of $14.2 million in Q4 2023, with year-to-date losses in 2024 amounting to $36.2 million compared to $54.5 million in 2023 [32] Business Line Data and Key Metrics Changes - The number of unique ordering accounts increased by 43% year-over-year from 199 to 284, with account utilization improving as average units sold per ordering account rose 10% from 12.3 to 13.5 units [13][14] - The launch of the TriNav LD infusion system and TriGuide guiding catheter expanded the PEDD portfolio, optimizing therapeutic delivery and improving procedural efficiency [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 year-to-date [28] - The PROTECT registry study is evaluating TriNav for non-malignant thyroid goiters and nodules, representing a market of approximately 50,000 annual procedures and a $400 million incremental opportunity [15] Company Strategy and Development Direction - The company prioritized its pressure-enabled drug delivery technology, aiming for EBITDA positivity by mid-2025 and cash flow positivity by year-end 2025 [10][22] - Strategic partnerships are being sought to advance the nelitolimod program in uveal melanoma liver metastases, with a focus on expanding reimbursement for radioembolization mapping [19][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving over 50% revenue growth in 2025, alongside positive full-year EBITDA and cash flow in the second half of 2025 [22][29] - The company aims to deepen penetration in the complex liver embolization market and enhance health economic and outcome research data [21][23] 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 identified in stock-based compensation and clinical trial-related R&D expenses [25][26] Q&A Session Summary Question: Where is the uptake for the launch of TriNav large vessels? - Management noted that TriNav is primarily being used in TARE more than TACE, particularly for larger vessel applications [36][38] Question: Can you provide insight on current mapping with TARE? - Management confirmed that the new CMS code allows for mapping and treatment in Medicare patients, which opens up about 25% of the market [41][46] Question: What should be expected in the PERIO-03 data? - Management clarified that the Phase I study is not to be compared to systemic chemotherapy, focusing instead on the technology's safety and efficacy [49][50] Question: Can you provide more color on account openings? - Management indicated a deliberate strategy to focus on driving utilization in existing accounts rather than aggressively opening new ones [63][65] Question: What is the attachment rate of mapping cases today in commercial? - Management believes the attachment rate is close to one-to-one on the commercial side, as mapping with the same technology yields better outcomes [80][81] Question: What is the status of the 10-K filing delay? - Management is working through the audit process and is hopeful that the numbers will not change significantly [90][92]

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]