Executive Summary

Q3 revenue of $7.35M grew 42% YoY, with gross margin at 86% (vs 89% YoY), and operating loss improving to $8.7M from $18.6M a year ago; sequential revenue was essentially flat vs Q2 ($7.36M) as summer utilization softened before a strong September ramp .
Management introduced 2025 guidance: >50% sales growth, >20% OpEx reduction, positive full‑year EBITDA, and positive cash flow in H2’25; emphasis on TriNav LV launch, expanded reimbursement, and DELIVER/PROTECT clinical program to expand the addressable market .
Commercial execution highlighted by 42 net new hospital accounts and utilization rising to 15.3 units/account in Q3; sales/clinical specialists expected to reach ~50 by year‑end to support sustained 50% growth into 2025 .
Liquidity: $11.3M cash at 9/30 plus $25M available on OrbiMed facility supports runway through 2025; plan to draw $10M in early Q1’25; focus on OpEx discipline as PERIO Phase 1 trials wind down .
Estimate comparison: S&P Global consensus for Q3 2024 could not be retrieved due to provider rate limits; thus, beat/miss vs Street not determinable at this time (see Estimates Context) .

What Went Well and What Went Wrong

What Went Well
- 42% YoY revenue growth with 86% gross margin; operating loss halved YoY on higher volume and R&D/G&A reductions .
- Product expansion: launch of TriNav LV and TriGuide to access larger vessels; positions full access to ~$375M liver embolization market, with same HCPCS codes easing adoption .
- Clinical momentum: positive PERIO‑01 Phase 1 (UM‑LM) data presented at SITC; strategic shift to partner nelitolimod for UM‑LM to accelerate development .
- Quote: “We’re on track to drive sustained growth of 50% annually for the foreseeable future” — CEO Mary Szela .
- Commercial KPIs: 42 net new hospital accounts added; utilization rose to 15.3 units/account in Q3 .
What Went Wrong
- Sequential revenue flat vs Q2 ($7.35M vs $7.36M) due to weaker July–August utilization before a strong September; Q3 gross margin dipped to 86% from Q2’s 88% .
- Q3 GAAP net loss to common was $2.4M; results remain influenced by non‑cash fair‑value movements (e.g., +$5.0M change in SEPA/warrant/revenue base liabilities and +$2.36M earnout) .
- Continued cash burn ($11.3M in Q3) necessitates disciplined OpEx cuts and external liquidity draws; management targets Q4 burn of ~$4–4.5M and H2’25 positive cash flow .

Financial Results

Metric	Q3 2023	Q2 2024	Q3 2024
Revenue ($USD Millions)	$5.19	$7.36	$7.35
Gross Margin (%)	89%	88%	86%
Operating Loss ($USD Millions)	$(18.62)	$(8.17)	$(8.74)
Net Loss/Share (Basic & Diluted)	$(0.14)	$(0.21)	$(0.12)
Cash & Cash Equivalents (End of Period, $USD Millions)	—	$16.48	$11.29

Segment/Product Mix (Q3 2024)

Revenue source: 100% from TriNav system device sales .

Revenue Breakdown	Q3 2024
TriNav Device Revenue ($USD Millions)	$7.35
% of Total Revenue	100%

Key Performance Indicators (Q3 2024)

KPI	Q3 2024
Net New Hospital Accounts (Quarter)	42
Utilization (Units per Account)	15.3
Accounts Receivable ($USD Millions)	$4.91
Inventory ($USD Millions)	$4.00

Non‑GAAP/Non‑cash items (Q3 2024)

Change in fair value of SEPA, warrant, revenue base redemption liabilities: +$4.97M; contingent earnout: +$2.36M, affecting reported net loss .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance (Introduced Q3’24)	Change
Sales Growth	FY 2025	N/A	>50% YoY growth	New
Operating Expenses	FY 2025	N/A	>20% decline YoY	New
EBITDA	FY 2025	N/A	Positive full‑year	New
Free Cash Flow	FY 2025	N/A	Positive in H2 2025	New

Note: Q3’24 guidance did not include an explicit gross margin target; a >87% FY25 GM target was later reiterated with Q4’24 results (outside the Q3 scope) .

Earnings Call Themes & Trends

Note: No Q1’24 earnings materials were found in our corpus; we compare Q2’24 to Q3’24 where applicable.

Topic	Previous Mentions (Q2 2024)	Current Period (Q3 2024)	Trend
Product expansion (TriNav LV/TriGuide; TriNav 2.0)	DELIVER program announced; product roadmap discussed broadly	TriNav LV and TriGuide launched for larger vessels; TriNav 2.0 targeted for 1H/2H 2025 with improved tracking	Expanding portfolio; access to larger market
Market development & reimbursement	Permanent TriNav reimbursement; plan to expand usage in complex cases	TriNav LV under same HCPCS codes; mapping procedure code context and broader reimbursement positioning highlighted	Smoother billing integration; supports adoption
Clinical programs (DELIVER/PROTECT)	DELIVER introduced; PROTECT planned to start	PROTECT registry initiated; aims for 100 pts across 5 sites; thyroid embolization adds ~$400M opportunity (~50k procedures)	Clinical expansion beyond liver into thyroid
Immunotherapy (nelitolimod PERIO)	Final Phase 1 data expected in Q4’24	Positive PERIO‑01 UM‑LM data at SITC; actively pursuing partner; PERIO‑03 (LAPC) enrollment completed; mid‑2025 data	Pivot to partnership; pancreas next‑step gated to data
Commercial execution	Sustained growth; debt facility to fund growth	+42 net new accounts; 15.3 units/account; ~50 commercial personnel by YE; 50%+ growth target reiterated	Scaling the field; focus on utilization + new logos
Liquidity/Balance sheet	$16.5M cash (6/30) + OrbiMed facility; runway through 2025 if thresholds met	$11.3M cash (9/30); $25M undrawn capacity; plan $10M draw early Q1’25; aim for H2’25 cash flow positive	Adequate runway; burn declining into 2025

Management Commentary

Strategic stance: “We’re on track to drive sustained growth of 50% annually for the foreseeable future,” supported by product launches and clinical advancement (CEO) .
Market access: TriNav LV “provides full access to the $375 million chemo and radio embolization market,” with same HCPCS codes enabling seamless integration (CEO) .
Clinical pivot: “We are actively pursuing a strategic partnership for nelitolimod [UM‑LM]” following positive PERIO‑01 Phase 1 results at SITC (CEO) .
Operating discipline: “Operating expenses should decline by 20%... Positive full‑year EBITDA and positive cash flow in the second half” of 2025 (CFO) .

Q&A Highlights

2025 revenue drivers: Guidance assumptions primarily reflect TACE/TARE; early thyroid cases occurring but immaterial near‑term (CFO) .
Nelitolimod path: Company will partner UM‑LM; HCC/ICC (PERIO‑02) to proceed via investigator‑initiated studies; PERIO‑03 (pancreas) decision post mid‑2025 data (CFO) .
Utilization and account growth: 2025 plan assumes avg same‑store usage rising to 17.5 units; ~50 new accounts in 2025; ~$5M 2025 sales contribution expected from TriNav Large (CFO) .
Pancreatic infusion reimbursement: Category III code submission planned Feb 2025; potential approval mid‑2025, then pursue Category I (CEO) .
Cash burn trajectory: Q3 burn “a tad over $11M”; expected to drop to $4–$4.5M in Q4; aim for H2’25 positive cash flow (CFO) .

Estimates Context

We attempted to pull S&P Global (Capital IQ) consensus for Q3 2024 revenue and EPS, but the provider returned a daily rate limit error; as a result, we cannot present definitive beat/miss vs the Street at this time [GetEstimates error].
On the call, one analyst referenced “consensus… $8.2 million,” and management reiterated 2024 revenue range of $28–$30M; the specific consensus context was not clarified on the call (analyst/CFO) .
If desired, we can refresh S&P Global consensus in a follow‑up once access resets and update the beats/misses accordingly.

Key Takeaways for Investors

Core device business executing: YoY growth +42% with 86% GM; sequential softness appears seasonal; September was a record month, supporting Q4 exit momentum .
Portfolio unlocks TAM: TriNav LV fills large‑vessel gap and, together with TriGuide, targets full access to a ~$375M market; same HCPCS codes should ease adoption and billing .
New indications expand opportunity: PROTECT registry opens a ~$400M thyroid embolization opportunity (~50k procedures), pushing total addressable market beyond $1B .
2025 inflection: Management targets >50% sales growth, >20% OpEx cut, positive EBITDA and H2’25 FCF; key drivers are market share gains, TriNav LV, and OpEx discipline as PERIO trials wind down .
Liquidity manageable: $11.3M cash plus OrbiMed capacity, with $10M draw planned in early Q1’25; burn trending down as G&A/clinical costs normalize .
Pipeline strategy de‑risked: Positive PERIO‑01 supports partnering nelitolimod in UM‑LM; PERIO‑03 decision gated to mid‑2025 data, limiting internal cash needs until clearer efficacy signals emerge .
Trading setup: Near‑term catalysts include TriNav LV adoption ramp, PROTECT site activations/enrollment updates, reimbursement milestones for pancreatic infusion, and partnership progress on nelitolimod—each a potential stock mover as execution and timelines are clarified on subsequent updates .

Supporting detail and source citations:

Q3 2024 8‑K earnings release and financials
Q3 2024 earnings call transcript (prepared remarks and Q&A)
Q2 2024 8‑K earnings release for sequential comparison

Estimates note: We attempted to retrieve S&P Global consensus for Q3 2024, but access was rate‑limited at the time of query; we will update beats/misses once access resets.

TriSalus Life Sciences, Inc. (TLSI)·Q3 2024 Earnings Summary