TriSalus Life Sciences, Inc. (TLSI)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 revenue grew 42% year over year and 11% sequential to $9.2M, driven solely by TriNav sales; gross margin was 84% and operating loss improved to $7.3M . CMS issued HCPCS code C8004 effective April 1, enabling reimbursement for TriNav in radioembolization mapping—a clear adoption catalyst .
• Guidance update: management reaffirmed “at least 50%” 2025 revenue growth, but no longer expects EBITDA positive or cash flow positive in 2025 as they prioritize growth investments (commercial expansion, new clinical applications) .
• Balance sheet strengthened post-quarter via a $22M gross private placement and a preferred-to-common exchange initiative supported by holders of ~55% of Preferred Stock, simplifying capital structure and adding runway .
• Commercial KPIs inflected: unique ordering accounts up 39% YoY in Q1; ~32 new accounts added; market share reached ~10% of liver TACE/TARE; TriNav Large and TriGuide broadened vessel coverage; TriNav Flex launch is forthcoming .
• Evidence, reimbursement, and portfolio breadth (TriNav Large, TriGuide, Flex) plus mapping code are near-term stock catalysts for adoption; Nelitolimod partnering readouts remain medium-term optionality .

What Went Well and What Went Wrong

• What Went Well

  • Revenue momentum and share gains: $9.2M (+42% YoY; +11% QoQ), with market share at 10% of liver TACE/TARE procedures . “Our results for the quarter position us as one of the fastest-growing med tech companies in the interventional oncology space.”
  • Reimbursement tailwind: CMS issued HCPCS C8004 for TriNav mapping, enabling use in both planning and treatment for Y-90 and accelerating broader adoption .
  • Portfolio expansion: TriNav Large and TriGuide launched to address larger vessels; TriNav Flex showed improved trackability ahead of full launch; management emphasized expansion into new applications (thyroid, GAE, UFE) via registries .

• What Went Wrong

  • Profitability timing: management explicitly guided that EBITDA and cash flow will not be positive in 2025, reversing prior targets to fund growth initiatives (sales force, registries) . Analysts probed cadence and back-half weighting of growth .
  • Gross margin dip: GM 84% in Q1, down from 85% in Q1 2024, due to clean room expansion disruptions; recovery expected to upper-80s in Q2+ .
  • Estimates visibility: Wall Street consensus (S&P Global) for TLSI quarterly revenue/EPS was unavailable, limiting “beat/miss” analysis this quarter (see Estimates Context). Values retrieved from S&P Global.*

Financial Results

Notes:

• Q1 2025 adjusted EBITDA reported for the first time; management plans ongoing disclosure .
• Sequential revenue +11% (Q4→Q1) as stated by CFO .

Segment revenue breakdown:

KPIs and Commercial Metrics:

Guidance Changes

Drivers of change:

• Strategic choice to invest in commercial expansion (targeting 60–70 field team over 18–24 months) and multiple registries (GAE, UFE, thyroid) to expand addressable market and utilization .

Earnings Call Themes & Trends

Management Commentary

• “For our first quarter of 2025, we delivered $9.2 million in net sales, a 42% increase compared to Q1 2024 and 11% sequential gain over Q4 2024.”
• “On April 1, CMS issued a HCPCS code C8004… In effect, this doubles the reimbursable use of our technology for Y-90 and supports broader adoption.”
• “We want to confirm our guidance of at least 50% revenue growth… As a result, we do not anticipate being EBITDA positive or cash flow positive in 2025.”
• “Subsequent to the end of Q1, we raised approximately $22 million in gross proceeds through a private placement… and reached agreement with 55% of our preferred shareholders to implement an exchange offer.”

Q&A Highlights

• PERIO-03 pancreatic readout: dose-ranging Phase I using venous PEDD; ~50% of 12 treated patients alive; focus on innate stimulation and partner interest; full data 2H 2025 .
• TriNav Large adoption: used for larger arteries (3–5mm), broader lobar treatments, uterine fibroids and thyroid cases; strong physician feedback .
• Gross margin trajectory: clean room expansion completed; GM expected to recover to upper-80s, with potential for ~90% in strong quarters .
• Salesforce expansion and revenue cadence: layering hires with biggest impact in Q4 and 2026; emphasis on utilization growth across multiple IRs per hospital .
• TARE vs TACE usage: trend skewing toward TARE, now #1 loco-regional therapy for liver transplant list maintenance; mapping code supports adoption .

Estimates Context

• Wall Street consensus (S&P Global) for TLSI quarterly revenue, EPS, and EBITDA was unavailable for the current and near-forward quarters when queried. Values retrieved from S&P Global.*
• Implication: No formal “beat/miss” versus consensus can be determined this quarter; the 42% YoY and 11% QoQ revenue growth, and gross margin trajectory should inform models. Management’s shift away from 2025 EBITDA/cash flow positivity necessitates downward revisions to near-term profitability assumptions while maintaining top-line growth targets .

Key Takeaways for Investors

• TriNav adoption remains the core driver: strong Q1 revenue growth, expanding market share, and a broadened portfolio (Large, TriGuide, Flex) support sustained adoption and utilization growth, especially with new mapping reimbursement .
• Profitability timeline pushed out: expect heavier 2025 operating spend (commercial build, registries); model EBITDA/cash flow turning positive beyond 2025 while top-line growth remains at least 50% for 2025 .
• Margin recovery lever: manufacturing expansion complete; GM expected to trend back to upper-80s as capacity normalizes—watch Q2 print for confirmation .
• Reimbursement catalyst: HCPCS C8004 expands reimbursable use to mapping in Medicare, aligning with commercial practice, improving economics and predictability—should accelerate TriNav penetration in Y-90 .
• Optionality from nelitolimod partnerships: Phase I data in UM-LM and upcoming PERIO-03 readout underpin partnering discussions while removing internal development expense post-2025 .
• Capital and structure: $22M private placement and preferred exchange (55% support) strengthen liquidity and simplify cap structure—aiding execution of growth plan in 2025 .
• Trading lens: near-term narrative grounded in reimbursement/access and utilization growth; medium-term pivots to margin normalization and partnership value—stock likely reacts to utilization KPIs, GM recovery, and any nelitolimod deal progress .

Sources

• Q1 2025 earnings call transcript
• Q4 2024 earnings call transcript
• Q3 2024 8-K/press release and earnings call transcript
• Q2 2024 8-K press release
• Q1 2025 8-K (includes Item 2.02 preliminary revenue and financing details)

*Values retrieved from S&P Global.