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TL

TriSalus Life Sciences, Inc. (TLSI)·Q1 2024 Earnings Summary

Executive Summary

  • TLSI delivered 116% year-over-year revenue growth to $6.46M with record quarterly sales, 85% gross margin, and continued >50% full-year growth outlook; device segment (ex-clinical costs) expected to approach positive EBITDA late-2024 .
  • OrbiMed debt facility of up to $50M extends liquidity: $25M drawn plus $4M cash at 3/31/24 funds operations through 2024; management indicates runway to end of 2025 assuming full $50M draw and revenue milestones/other liquidity sources .
  • Commercial momentum: 32 net new hospital accounts in Q1 and utilization rose to 14.5 units/account (vs 11.2 LY), aided by permanent reimbursement (HCPCS C9797 effective Jan 1) and sales force expansion .
  • Near-term catalysts: PERIO-02 data at ASCO (liver indications), Q3 board decision on nelitolimod lead indication, and TriNav Large launch now targeted for Q4 after market eval completion—key drivers for sentiment and uptake .

What Went Well and What Went Wrong

  • What Went Well
    • Sustained hypergrowth and margin strength: revenue up 116% YoY to $6.46M with 85% gross margin; gross margin benefited from volume, yields, and efficiencies .
    • Adoption KPIs accelerated: 32 net new accounts and utilization rose to 14.5 units/account (vs 11.2 LY), reflecting pent-up demand post-permanent reimbursement .
    • Operational and financing execution: OrbiMed credit facility up to $50M supports TriNav growth; mgmt reiterates >50% FY24 sales growth plan and device segment approaching positive EBITDA late-2024 .
  • What Went Wrong
    • Losses widened YoY on growth investments: operating loss $(11.69)M vs $(10.12)M LY; net loss available to common $(13.22)M vs $(8.27)M LY; higher S&M, R&D, and public company costs offset gross profit gains .
    • Non-cash fair value items added volatility: changes in SEPA/warrant (+$2.52M) and contingent earnout (−$3.99M) impacted GAAP net loss; investors must normalize for these effects .
    • Cash declined to $3.97M at Q1-end pre-debt draw, highlighting dependence on external financing and execution against revenue milestones to access remaining tranches .

Financial Results

Sequential and YoY comparisons

MetricQ3 2023Q4 2023Q1 2024
Revenue ($USD Millions)$5.19 $5.72 $6.46
Gross Profit ($USD Millions)$4.60 $5.14 $5.49
Gross Margin %89% 90% 85%
Operating Loss ($USD Millions)$(18.48) $(14.12) $(11.69)
Net Loss Available to Common ($USD Millions)$(1.29) $(35.51) $(13.22)
EPS, Basic & Diluted ($)$(0.13) $(1.56) $(0.60)
Cash & Equivalents (Period End, $USD Millions)$21.38 $11.78 $3.97
MetricQ1 2023Q1 2024
Revenue ($USD Millions)$2.98 $6.46
Gross Profit ($USD Millions)$2.32 $5.49
Gross Margin %78% 85%
Operating Loss ($USD Millions)$(10.12) $(11.69)
Net Loss Available to Common ($USD Millions)$(8.27) $(13.22)
EPS, Basic & Diluted ($)$(0.57) $(0.60)

Notes:

  • Revenue entirely from TriNav; no formal segment disclosure in Q1 materials .
  • Q1 GAAP net loss reflects non-cash fair value items (SEPA/warrant +$2.52M; contingent earnout −$3.99M) .

KPIs

KPIQ1 2023Q4 2023Q1 2024
Net New Hospital Accounts (units)11 32
Utilization per Account (units/account)11.2 12.7 14.5
Sales Representatives (count)10 (beg. ‘23) 28 27
Clinical Specialists (count)7 7
TriNav Market Share (liver TACE/TARE)7% FY23

Estimates vs. Actuals

  • Wall Street consensus (S&P Global) for Q1 2024 revenue/EPS was not available at the time of analysis; therefore, no estimate comparison is presented. The absence of estimates may reflect limited analyst coverage for TLSI.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Sales growthFY 2024“Growth in excess of 50%” (Q4 call) “Full year sales growth expected to exceed 50%” Maintained
Device segment EBITDA (ex-nelitolimod clinical costs)Late 2024“Approach break-even late 2024” “Expected to approach positive EBITDA late in 2024” Maintained/Clarified
Clinical trial costs2024Expected to decrease in 2024 Expected to decrease for balance of 2024 Maintained
Cash runway2024–2025Liquidity into Q2 2024 pre-financing Through 2024 with initial $25M draw; to end of 2025 assuming full $50M draw + milestones/other liquidity Raised materially
TriNav Large launch timing2H 2024Launch in 2H 2024 Market eval completes Q3; launch targeted Q4 2024 Narrowed/timing specified

Earnings Call Themes & Trends

TopicQ3 2023 (prior-2)Q4 2023 (prior-1)Q1 2024 (current)Trend
Reimbursement & real-world evidenceBuilding evidence; PERIO data and PRVI feasibility discussed Permanent HCPCS (C9797) effective Jan 1; strong RWE and manufacturing gains Adoption uplift, utilization higher; continued emphasis on value in complex patients Positive tailwind
TriNav adoption & utilization$5.2M revenue; early public company phase Record $5.7M revenue; utilization 12.7/account Record $6.46M; utilization 14.5/account; +32 new accounts Accelerating
Gross margin & ops89% GM in Q3 90% in Q4; FY23 86% 85% in Q1 (mix/scale dynamics), still robust Strong/within band
Pipeline: nelitolimodSITC data and PRVI feasibility; path to combos Multiple Phase 1 programs completed enrollment; data in 2H24 ASCO PERIO-02 data upcoming; Q3 board decision on lead indication Key 2H24 catalyst
Financing/liquidityPost-SPAC context Ended FY23 with $11.8M cash; seeking more liquidity OrbiMed facility up to $50M improves runway Improved
Product roadmap (TriNav Large)510(k) cleared; market expansion potential Plan to launch 2H24; ~25% incremental market access Market eval thru Q3; launch targeted Q4 On track, timing specified

Management Commentary

  • “I’m proud to highlight our strong start in the first quarter of 2024 with 116% growth in revenues… With our recent positive developments in reimbursement, clinical data… we’re confident… Our objectives of achieving over 50% top-line revenue growth… remain firmly on track.” — CEO Mary Szela (press release) .
  • “Our revenue… reached $6.5 million… the highest quarterly sales in the company’s history… account utilization reached 14.5 units per account… robust gross margin profile of 85%… This segment… is expected to approach positive EBITDA late in 2024.” — CFO Sean Murphy .
  • “We look forward to presenting… PERIO-02 at ASCO… Enrollment has been successfully concluded [across multiple liver indications] and nearing completion for pancreatic… we’ll recommend a lead indication to the board in the third quarter.” — CEO Mary Szela .
  • “Market evaluation [of TriNav Large]… will be completing in the third quarter, launching in the fourth quarter… validated need in TACE and larger vessel size cases.” — CEO Mary Szela .

Q&A Highlights

  • Pipeline prioritization: Management will wait for patient maturation (~6 months for recent enrollees) and intends to select a single lead indication with strong treatment effect and a clear/accelerated regulatory path; board decision targeted for Q3 .
  • TriNav Large launch: Extensive market evaluation with key users underway; need validated, particularly for TACE and large vessel cases; launch guided for Q4 after completing evaluation in Q3 .

Estimates Context

  • S&P Global consensus estimates for Q1 2024 revenue and EPS were not available at the time of analysis; as a result, we cannot quantify beat/miss vs. Street for this quarter. Given the strong 116% YoY revenue growth, lack of formal segments, and reiterated >50% FY growth outlook, we would expect upward bias to outer-quarter sales expectations, contingent on continued account adds and utilization gains .

Key Takeaways for Investors

  • Commercial engine is working: record revenue, rising utilization, and robust margins support sustained >50% FY24 growth narrative; watch utilization and account adds as leading indicators .
  • Profit inflection path: device segment approaching positive EBITDA late-2024 (ex-clinical costs); leverage from scale and manufacturing yield improvements remains a key thesis pillar .
  • Liquidity de-risked: OrbiMed facility and initial $25M draw extend runway (through 2024; potentially 2025 with full $50M, milestones, and other liquidity); reduces near-term financing overhang but execution on revenue thresholds is critical .
  • Pipeline catalysts: PERIO-02 ASCO data and Q3 indication decision for nelitolimod are binary-like events for sentiment; “go-forward” indication likely singular initially due to financing discipline .
  • Product expansion: TriNav Large Q4 launch can broaden addressable embolization market; successful launch could further lift utilization and ASP mix in TACE settings .
  • Normalize GAAP: Fair value adjustments (SEPA/warrants/earnout) introduce net loss volatility; focus on operating loss/EPS and device EBITDA trajectory for core performance assessment .
  • Risk-reward hinges on execution: Continued account growth, TriNav Large launch, and positive, actionable clinical data are the main stock catalysts over the next 6–9 months .