Executive Summary

Q2 2024 revenue grew 60% year over year to $7.4M, with gross margin expanding to 88%; operating loss narrowed to $8.2M and EPS improved to $(0.21) versus $(35.84) in Q2 2023, driven by higher volumes and efficiency gains .
Management maintained full-year 2024 revenue growth outlook “over 50%” and expects to approach positive EBITDA (excluding nelitolimod costs) late 2024; cash runway expected through end of 2025 assuming full debt facility access .
Strategic updates: announced DELIVER program starting Q3 2024 (first study “PROTECT” in thyroid goiter), final Phase 1 data readouts for PERIO-01 (uveal melanoma liver metastases) and PERIO-03 (locally advanced pancreatic cancer) targeted for Q4 2024; TriNav Large launch later in 2024 at same ASP as standard TriNav .
Financing and capital structure: closed $25M at signing of an up to $50M OrbiMed debt facility (additional $25M subject to revenue thresholds); completed warrant exchange (2.11M shares issued for ~7.0M warrants) to reduce potential dilution and simplify capital structure .
Wall Street consensus (S&P Global) for Q2 2024 EPS and revenue was unavailable at time of request, so formal beat/miss vs estimates cannot be assessed; key catalysts ahead include Q4 clinical data and TriNav Large launch .

What Went Well and What Went Wrong

What Went Well

Robust revenue growth with record quarterly sales: Q2 revenue $7.4M (+60% YoY), H1 revenue $13.8M (+82% YoY); margin expansion to 88% in Q2 and 86% YTD, driven by factory volumes and operational efficiency .
Commercial execution: 27 new hospital accounts added in Q2; account utilization rose to 15.2 units per account vs 12.4 in Q2 2023; management reiterated track record of >50% CAGR since 2020 and 2024 revenue growth >50% .
Strategic pipeline and programs: DELIVER program announced to broaden TriNav use in complex patients; Q4 readouts for PERIO-01 and PERIO-03 targeted, with TriNav Large launch planned later in 2024 to expand addressable market .

Selected management quote: “We concluded the second quarter with robust revenue growth and effective execution… We are excited to launch the DELIVER program… and look forward to presenting our final Phase 1 data… in the fourth quarter.” — Mary Szela, CEO .

What Went Wrong

Continued net losses, albeit improved: Q2 net loss available to common stockholders was $(4.3)M; non-cash fair value changes contributed ($9.0)M loss on SEPA/warrant/revenue base redemption liabilities, partially offset by $13.7M gain on contingent earnout liabilities .
PERIO-02 (HCC/ICC) decision: despite safety/immunologic consistency and encouraging activity in a limited cohort on ipi/nivo + nelitolimod, the company will not proceed to Phase II due to limited data and resource prioritization; may pursue investigator-initiated studies with TACE/TARE combos .
Lack of numeric revenue guidance ranges and dependency on continued sales force expansion: 2024 outlook remains directional (>50% growth) without specific targets; S&M expenses increased to support growth strategy .

Financial Results

Income Statement and EPS (Quarterly)

Metric	Q4 2023	Q1 2024	Q2 2024
Revenue ($USD Millions)	$5.721	$6.457	$7.364
Gross Margin (%)	90%	85%	88%
Loss from Operations ($USD Millions)	$(14.118)	$(11.685)	$(8.174)
Net Loss Available to Common Stockholders ($USD Millions)	$(35.509)	$(13.219)	$(4.332)
Basic & Diluted EPS ($USD)	$(1.56)	$(0.60)	$(0.21)
Weighted Avg Shares (Basic & Diluted)	23,231,975	23,323,045	23,903,659

Year-over-Year Comparison (Q2 2024 vs Q2 2023)

Metric	Q2 2023	Q2 2024	YoY Change
Revenue ($USD Millions)	$4.612	$7.364	+60%
Gross Margin (%)	83%	88%	+500 bps
Loss from Operations ($USD Millions)	$(11.434)	$(8.174)	+$3.260M improvement
EPS ($USD)	$(35.84)	$(0.21)	+$35.63 improvement (share base normalized)

Notes:

Non-cash fair value items in Q2 2024: ($9.0)M loss (SEPA/warrant/revenue base redemption) and $13.7M gain (contingent earnout), influencing net results .
Revenue is entirely from TriNav device sales .

Segment Revenue Breakdown

Segment	Q4 2023	Q1 2024	Q2 2024
TriNav Device Sales (% of Revenue)	100%	100%	100%

Commercial KPIs

KPI	Q1 2024	Q2 2024
New Hospital Accounts Added (Quarter)	32	27
Units per Account (Utilization)	14.5	15.2

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Revenue Growth	FY 2024	“Full year sales growth expected to exceed 50%”	“Continue to forecast 2024 growth over 50%”	Maintained
EBITDA (ex-nelitolimod costs)	FY 2024	“Expected to approach positive EBITDA late in 2024”	“Expect to approach positive EBITDA late in 2024”	Maintained
Cash Runway	Through FY 2025	“Assuming full $50M debt facility access, runway through end of 2025”	“Assuming full $50M debt facility access, runway through end of 2025”	Maintained
TriNav Large Launch Timing & Pricing	2H 2024	“Launch in 2H 2024” (transcript: Q4)	“Later this year; same ASP as TriNav”	Maintained (pricing clarified)
DELIVER Program	Starts Q3 2024	Not previously disclosed	“Plan to launch in Q3 2024; first study PROTECT (thyroid goiter)”	New
PERIO-01 & PERIO-03 Data Timing	Q4 2024	“Analyze 2H 2024”	“Final Phase 1 results expected in Q4 2024”	Refined timing
PERIO-02 Path Forward	N/A	Enrollment complete; ASCO top-line planned	No Phase II; consider investigator-initiated studies with TACE/TARE	Strategy pivot

Earnings Call Themes & Trends

Topic	Previous Mentions (Q4 2023, Q1 2024)	Current Period (Q2 2024)	Trend
Reimbursement & Adoption	CMS HCPCS 9797 effective Jan 1, 2024; positioning TriNav as preferred in complex patients	Continued adoption; 27 new accounts; utilization 15.2 units per account	Positive execution
Sales Force Expansion	Expanded to 27 reps and 7 clinical specialists	Adding 10 additional personnel to drive uptake	Accelerating
Gross Margin & Operations	90% GM in Q4 2023; 85% in Q1 2024; efficiency gains	88% GM in Q2; facility can support 5 years of growth with minimal capex	Sustainable margins
Pipeline (PERIO-01/02/03)	Enrollment completed; PERIO-02 top-line at ASCO; Phase 1 pancreatic device initiated	PERIO-02: safety/immune signals; do not proceed to Phase II; PERIO-01/03 final data Q4	Focused prioritization
New Programs (DELIVER/PROTECT)	Not disclosed prior	DELIVER unveiled; PROTECT to highlight TriNav vs surgery in thyroid goiter	Strategic expansion
Product Roadmap (TriNav Large)	510(k) clearance; market evaluation; H2 2024 launch	Launch later 2024; same ASP	On track
Financing & Capital Structure	DeSPAC costs in 2023; late filing notice; plan debt facility	$25M closed; up to $50M total; warrant exchange completed	Improved flexibility
Regulatory/Legal	510(k) clearances; CMS HCPCS granted	Continued trial progress; investigator-initiated studies possible	Steady progress
Supply Chain/Tariffs/Macro	Not highlighted	Not highlighted	Neutral

Management Commentary

“This quarter, we made significant progress in advancing our strategic priorities and continued to achieve robust revenue growth… marking another consecutive quarter of over 50% growth.” — Mary Szela .
“We are planning to launch a series of investigator-initiated clinical trials… This program named the DELIVER program… aims to demonstrate enhanced efficacy and overcome resistant mechanisms in difficult-to-treat cancers.” — Mary Szela .
“Our revenue… reached $7.4 million in the second quarter… highest quarterly sales in the company's history… gross margin 88% in the second quarter of 2024 and 86% year-to-date.” — Sean Murphy .
“In the 12 patients who received… nelitolimod via PEDD in combination with ipi and nivo, the disease control rate was 42%… however… the data… was too limited for us to proceed… we do not intend to proceed to Phase II.” — Steven Katz .
“We plan to report the final Phase I results for both programs by the end of this year.” — Steven Katz (PERIO-01/03) .

Q&A Highlights

DELIVER program scale: CMO estimated total addressable market for PROTECT (multinodular goiter) could reach up to 50,000 patients, with early data expected next year; company also sees complex subsets in colorectal liver metastases and HCC .
Indication prioritization: CEO emphasized selection criteria—significant treatment effect, large market, clear regulatory path, and financing feasibility—for choosing PERIO-01 vs PERIO-03; PERIO-01 market ~1,200 patients/year vs larger PERIO-03 market .
PERIO-02 strategy: strong investigator enthusiasm and encouraging safety/immune data, but not proceeding to Phase II; potential investigator-initiated studies combining nelitolimod with TACE/TARE .
TriNav Large commercial: launch later in 2024 at same price as standard TriNav; PROTECT uses bland embolization (particles) rather than radioembolization .

Estimates Context

S&P Global Wall Street consensus estimates for Q2 2024 EPS and revenue were unavailable at the time of request due to a data access limit; therefore, formal beat/miss versus consensus cannot be determined [functions.GetEstimates error].
Management reiterated 2024 revenue growth “over 50%” and expects to approach positive EBITDA (excluding nelitolimod costs) late in 2024, implying potential estimate revisions focused on top-line durability and margin trajectory .

Key Takeaways for Investors

Commercial momentum remains strong (record revenue, expanding utilization), with gross margin durability driven by scale and manufacturing efficiencies—near-term focus remains TriNav expansion .
Clear strategic prioritization: resources concentrated on indications with large markets and clearer pathways; PERIO-02 shifted to investigator-initiated combinations, while PERIO-01 and PERIO-03 await Q4 Phase 1 readouts—these data could reset medium-term optionality .
TriNav Large launch (same ASP) and DELIVER program (complex patients, PROTECT) broaden the procedural footprint and could unlock incremental utilization—catalysts for late 2024 and 2025 .
Capital structure and liquidity improved via OrbiMed facility and warrant exchange; runway through end-2025 (assuming full facility) reduces near-term financing overhang and supports commercial/pipeline execution .
Watch for Q4 2024 clinical data (PERIO-01/03) and early DELIVER datapoints—positive signals could enhance confidence in medium-term thesis and drive multiple expansion; absence of numeric guidance keeps valuation sensitive to reported trends .
Near-term trading implications: favorable revenue/margin trajectory and upcoming catalysts may be supportive; lack of consensus benchmarks this quarter tempers immediate “beat/miss” narrative and shifts focus to qualitative execution signals .
Monitor S&M spend and sales-force productivity as expansion continues; leverage in EBIT/EBITDA ex-nelitolimod costs is expected late in 2024, a potential inflection for investors focused on profitability milestones .

TriSalus Life Sciences, Inc. (TLSI)·Q2 2024 Earnings Summary