TriSalus Life Sciences, Inc. (TLSI) Q4 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call summary highlights strong financial performance with improved operating and EBITDA losses, alongside a reaffirmed 50% revenue growth guidance. Product development and strategic investments in the TriNav platform, coupled with expanding clinical applications, suggest growth potential. The Q&A session reveals optimism in product expansion and market penetration, though management's reluctance to provide specific financial guidance tempers enthusiasm. Overall, the combination of positive revenue outlook, strategic expansions, and improved financial metrics signals a positive stock movement.
Key Financial Performance
Fourth Quarter Revenue $13.2 million, representing a 60% year-over-year increase. The growth was driven by consistent execution of the commercial strategy and expansion of the TriNav product suite and PEDD platform.
Full Year Revenue $45.2 million, representing a 53% year-over-year increase. The increase was attributed to increased TriNav units sold within liver-directed therapies.
Gross Margin (Fourth Quarter) 87%, compared to 85% in the prior year period. The increase was driven by improving manufacturing efficiency associated with newly launched products.
Gross Margin (Full Year) 85%, compared to 86% in the prior year. The slight decline was due to lower manufacturing efficiencies associated with newly launched products during the second and third quarters, which improved in the fourth quarter.
Research and Development Expenses (Fourth Quarter) $2.6 million, down from $3 million in the prior year period. The decrease was due to the completion of enrollment and closure of PERIO clinical studies for nelitolimod.
Research and Development Expenses (Full Year) Decreased by $2.7 million compared to the prior year. The reduction was due to the closeout of clinical trial expenses related to nelitolimod.
Sales and Marketing Expenses (Fourth Quarter) $8 million, up from $7 million in the prior year period. The increase was due to higher performance-based compensation reflecting strong commercial execution.
Sales and Marketing Expenses (Full Year) Increased by $2.9 million compared to the prior year. The increase was due to higher performance-related compensation driven by increased sales.
General and Administrative Expenses (Fourth Quarter) $4.2 million, down from $4.6 million in the prior year period. The decrease was due to improved operational efficiency and tighter cost discipline.
General and Administrative Expenses (Full Year) Increased by $3.5 million compared to the prior year. The increase was due to a one-time charge of $1.6 million for accelerated noncash stock-based compensation vesting and a revision of $700,000 of certain patent-related expenses from R&D to general and administrative expenses.
Net Operating Loss (Fourth Quarter) $3.3 million, compared to $7.6 million in the prior year period. The improvement was driven by increases in revenue and margin contribution.
Adjusted EBITDA Loss (Fourth Quarter) Approximately $950,000, an improvement from $5.7 million in the prior year period. The improvement was due to increased revenue and margin contribution.
Operating Loss (Full Year) $26.9 million, compared to $36.2 million in the prior year. The improvement was driven by increased revenue and strong margin contribution, highlighting strong operating leverage.
Basic and Diluted Loss Per Share (Full Year) $1.84, compared to $1.31 in the prior year. The increase was due to the conversion of preferred stock to common stock.
Cash and Cash Equivalents (End of 2025) $20.4 million. Additionally, $46 million in gross proceeds was raised in February 2026 via a public offering.
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Operating Highlights
TriNav product suite and PEDD platform expansion: Expanded across a broad range of indications beyond the liver, including new products like TriNav LV, TriGuide, TriNav FLX, and TriNav XP. TriNav Advance is anticipated to launch in the first half of 2026.
New product launches: TriNav XP launched in Q4 2025, designed for compatibility with larger embolic particles and improved trackability. TriNav Advance, designed for selective therapy delivery, is awaiting 510(k) clearance and expected to launch in 2026.
Addressable market expansion: The embolization portfolio now addresses a $2.3 billion market, including liver embolization ($480 million) and other procedures like thyroid and uterine artery embolization.
Reimbursement expansion: CMS HCPCS code C8004 expanded coverage for simulation or mapping procedures using TriNav, doubling reimbursable use in the radioembolization market.
Revenue growth: Achieved $13.2 million in Q4 2025 and $45.2 million for the full year, representing 60% and 53% growth, respectively, over the prior year.
Sales force expansion: Doubling the commercial footprint to drive adoption and long-term success, with revenue cadence expected to be 40% in H1 2026 and 60% in H2 2026.
Clinical studies: Investing in foundational studies to validate PEDD's value, including thyroid artery embolization and knee osteoarthritis treatment.
Capital raise: Raised $46 million in gross proceeds in February 2026 to fund strategic priorities, including sales expansion and clinical studies.
Strategic focus: Prioritizing PEDD platform growth while reducing internal spending on nelitolimod, focusing on partnership opportunities for the latter.
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Risk or Challenges
Macroeconomic Conditions and Global Events: The company acknowledges material risks and uncertainties, including the impact of macroeconomic conditions and global events, which could cause actual results or events to materially differ from expectations.
Revenue Cadence and Commercial Expansion: The company anticipates revenue cadence to be weighted towards the second half of 2026 due to upfront hiring, onboarding, training, and territory realignment. This could influence near-term revenue phasing and create challenges in achieving consistent revenue growth.
Regulatory Approvals: The launch of TriNav Advance is contingent on receiving 510(k) clearance. Delays or failure to obtain regulatory approval could impact the company's ability to meet its strategic objectives.
Clinical Data and Partnership Delays: The company delayed the release of clinical data for the nelitolimod program to consolidate findings, which could affect partnership discussions and long-term value creation.
Manufacturing Efficiency: Lower manufacturing efficiencies associated with newly launched products impacted gross margins earlier in the year, though improvements were noted in the fourth quarter.
Sales and Marketing Costs: Increased sales and marketing expenses, driven by performance-based compensation and commercial expansion, could strain financial resources if revenue growth does not align with these investments.
Product Adoption and Market Penetration: The success of the PEDD platform and new product launches depends on physician adoption and market penetration. Challenges in these areas could hinder revenue growth and strategic execution.
Clinical Study Outcomes: The success of ongoing clinical studies, such as those for thyroid artery embolization and knee osteoarthritis, is critical for validating the PEDD platform. Negative or inconclusive results could impact market confidence and adoption.
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Guidance & Outlook
Revenue Guidance for 2026: TriSalus reaffirms its revenue guidance of $60 million to $62 million for 2026, with growth weighted towards the second half of the year. Revenue cadence is expected to be approximately 40% in the first half and 60% in the second half of the year.
Commercial Expansion: The company plans to double its commercial footprint in 2026, which includes upfront hiring, onboarding, training, and territory realignment. This expansion is expected to enhance productivity exiting 2026 and beyond.
Product Launches: TriNav Advance is anticipated to launch in the first half of 2026, with a full launch in the second half following 510(k) clearance and a rapid market evaluation. This product is expected to open significant market opportunities for PEDD.
Market Opportunities: The total addressable market for liver embolization procedures is approximately $480 million, while the broader embolization market represents a $2.3 billion opportunity. The company aims to leverage its expanded product portfolio to capture these markets.
Clinical Studies and Data: TriSalus is investing in foundational clinical studies to validate the PEDD platform's value, which will fuel growth in 2027 and beyond. The company also plans to publish HEOR data on TriNav use in complex liver patients in 2026.
Nelitolimod Program Update: A consolidated clinical update for the nelitolimod program is expected in the second half of 2026. This update will include data from all three PERIO Phase I studies and ongoing investigator-initiated studies.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:How should we think about the contribution from liver versus non-liver growth in 2026?
A:The majority of top-line revenue in 2026 will still be associated with liver. However, meaningful progress in non-liver applications is expected in the second half of the year, tied to data releases in areas like thyroid and uterine fibroid.
Q:How should we balance growth cadence and EBITDA pathway as the company builds the foundation for growth?
A:The company is not providing specific timing or guidance on cash flow breakeven or adjusted EBITDA breakeven. They are focused on investing in commercial expansion to position the company for meaningful scaling, with more visibility expected later in the year.
Q:What will the sales organization structure look like after the accelerated investment in the commercial footprint?
A:The company is doubling the size of the commercial organization, adding a layer of management, and expanding geographic coverage. They are pairing clinical specialists with representatives to enhance depth and expertise, which is expected to drive sales acceleration starting in the second half of the year.
Q:How much mapping growth is factored into the 2026 guidance, and what is the impact of new products like XP and Advance?
A:Mapping growth is expected to be meaningful, supported by the XP product's larger interior diameter and the pending FDA clearance of Advance, which offers enhanced imaging and mapping capabilities. These products, along with TriNav, are expected to significantly penetrate the mapping market.
Q:What are the use patterns for the TriNav product portfolio?
A:Some users prefer the flexibility and trackability of the TriNav Flex for all cases, while others utilize different catheters based on specific needs. Usage patterns vary across accounts.
Q:What are the medium to long-term opportunities for TriNav in liver versus non-liver applications?
A:Liver applications will remain a significant component of sales, with foundational studies planned to prove the technology's superiority. Non-liver applications like thyroid and uterine embolization are expected to grow, driven by data and physician adoption. The thyroid embolization market, in particular, shows significant potential for growth.
Q:Review of Unclear Management Responses
A:Management avoided providing specific details on the number of sales representatives and clinicians being hired, as well as the timing for cash flow and adjusted EBITDA breakeven. Additionally, responses about the long-term growth potential of non-liver applications were somewhat general, relying on future data and physician adoption without concrete projections.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
Investor
PERIO study
TriNav FLX
TriNav XP
advantage
afternoon
anatomy
beginning
capital market
care investor
change
commitment
depth
embolization portfolio
embolization procedure
expansion product
health care
investigator study
knee osteoarthritis
landscape
market adoption
microcatheter
nelitolimod
offering
onboarding training
preparation
productivity sale
radio embolization
realignment
registry GAE
revenue
review result
sale infrastructure
set
study completion
timing
training territory
week
TLSI Transcript
TriSalus Life Sciences, Inc. (TLSI) Q4 2025 Earnings Call Transcript
Positive3-5
The earnings call summary highlights strong financial performance with improved operating and EBITDA losses, alongside a reaffirmed 50% revenue growth guidance. Product development and strategic investments in the TriNav platform, coupled with expanding clinical applications, suggest growth potential. The Q&A session reveals optimism in product expansion and market penetration, though management's reluctance to provide specific financial guidance tempers enthusiasm. Overall, the combination of positive revenue outlook, strategic expansions, and improved financial metrics signals a positive stock movement.
TriSalus Life Sciences, Inc. (TLSI) Q3 2025 Earnings Call Transcript
Positive11-13
The earnings call reveals solid financial management, with improved cash flow and reduced operating losses. The company's commitment to a 50% growth target and strategic investments in new applications and products support a positive outlook. Despite management's reluctance to provide 2026 guidance, the market strategy and product development updates are favorable. The Q&A highlights robust feedback and growth in new applications, enhancing the sentiment. The positive aspects outweigh the lack of long-term guidance, suggesting a potential stock price increase in the short term.
TriSalus Life Sciences, Inc. (TLSI) Q2 2025 Earnings Call Transcript
Positive8-12
The earnings call highlighted strong financial performance with a 42% sales increase and a 50% growth guidance for 2025. Product innovations and successful reimbursement progress are positive indicators. Despite operating losses, improved EBITDA and cash position provide stability. The Q&A revealed positive market reception for new products and mapping technology, with strategic investments in sales expected to drive growth. However, uncertainties in partnership discussions and unclear timelines for nelitolimod present some risks. Overall, the positive financials, growth trajectory, and market reception outweigh the uncertainties, suggesting a positive stock price movement.
TriSalus Life Sciences, Inc. (NASDAQ:TLSI) Q1 2025 Earnings Call Transcript
Unknown5-17
The earnings call revealed mixed signals: strong revenue growth and reduced losses, but ongoing financial challenges and competitive pressures. The Q&A highlighted positive feedback on products and expansion efforts but also showed management's reluctance to provide clear guidance, raising concerns. The private placement and preferred share exchange offer could dilute stock value. Overall, the company's strategic initiatives and product performance are promising, but financial uncertainties and competitive challenges temper the outlook, resulting in a neutral sentiment.
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