TriSalus Life Sciences, Inc. Q3 FY2024 earnings call

• Product Launches: Launch of TriNav Large and TriGuide Catheter is underway. TriNav 2.0 to launch in H2 2025.
• Clinical Trials: PROTECT registry trial for TriNav in multimodular disease to launch by year-end. PERIO-03 enrollment of 13 patients completed. HEOR data update with additional year of TriNav outcome data.
• Commercial Expansion: Aim to have approximately 50 commercial personnel (sales and clinical specialists) by year-end to expand market footprint.
• Nelitolimod Progress: Phase 1 results from PERIO-01 trial in uveal melanoma liver metastases presented. PERIO-03 trial with pancreatic retrograde venous approach shows safety and potential, with data to be available mid-2025.

TriSalus reported total revenue of $7.3 million for Q3 2024, reflecting a 42% growth compared to Q3 2023. Year-to-date revenue stands at $21.2 million, a 66% increase from the prior year. The gross margin was 86% in Q3 2024, consistent with year-to-date margins. The main product, TriNav, drives the revenue growth. The Westminster, Colorado facility produced more TriNav units in the first three quarters of 2024 than all of 2023.

• 2025 sales growth expected to be over 50% driven by expanding TriNav market share, TriNav Large launch, and DELIVER program.
• Operating expenses expected to decline by 20% due to reduced clinical trial costs and lower G&A expenses.
• Aim to be EBITDA positive in 2025 and achieve positive cash flows in the second half of 2025.

Q: In terms of 2025 guidance, what's in the assumptions regarding TriNav adoption and cost assumptions?

A: Sales force targets taste and tear market, average usage per account expected to increase to 17.5 units in 2025 from 15.3 in Q3 2024. Expect 50 new accounts in 2025 and $5 million forecast for training.

Q: Regarding nelitolimod, are you seeking partners for all indications?

A: On uveal melanoma liver metastases, partnering is planned; for other indications like PERIO-02, not doing formal programs, and PERIO-03 data will determine next steps.

Q: For the pancreatic retrofit venous infusion system, any reimbursement advancements?

A: Submitting for Category 3 code in February 2025, expected approval mid-2025, then aiming for Category 1 code.

Q: Thoughts on multinodular goiters treatment paradigm compared to standard care?

A: Multinodular goiters are commonly treated with surgery, but TriNav offers a minimally invasive alternative with benefits like reduced complications and minimal downtime. Excited about the 50,000+ potential procedures in the US.

Q: Commentary on 2024 guidance and cash burn?

A: 2024 revenue range $28M-$30M. Cash burn in Q3 was over $11M, expected to drop to $4M-$4.5M in Q4, with cash flow positive in second half of 2025.

Q: PERIO update on pancreas efficacy?

A: Enrolled 13 patients, waiting for longer follow-up and correlative data from tissue samples to assess efficacy, with readout expected mid-2025.

Q: Competitive landscape for TriNav and TriNav Large?

A: No direct competitors in TriNav for liver applications. HCPCS code written specifically for TriNav technology. Pancreatic device has unique pressure modulation not seen in competitors.