TriSalus Life Sciences, Inc. Q4 FY2024 earnings call

• In 2024, TriSalus prioritized its pressure-enabled drug delivery (PEDD) technology, reduced R&D expenses, and aimed for EBITDA positivity by mid-2025 and cash flow positivity by year-end.
• Achieved $29.4 million in net sales in 2024, a 59.4% growth over 2023. Clinical studies in TACE and TARE showed improved therapeutic delivery. The PROTECT registry study is evaluating TriNav for non-malignant thyroid goiters. A new HCPCS code for TriNav simulation/mapping was issued by CMS. Launched TriNav LD infusion system and TriGuide guiding catheter. Completed Phase I trials for nelitolimod. Secured up to $50 million in debt financing from OrbiMed, with $35 million accessed to date. Cash runway extends through 2025.

In the fourth quarter ending December 31, 2024, revenue driven by TriNav device in the U.S. reached $8.3 million, a 44% increase from the same period in 2023 and a 12% sequential increase. For the full year 2024, revenue was $29.4 million, a 59% increase from the prior year. TriNav is the sole driver of revenue, with its sales contributing significantly to the company's growth.

• 2025 guidance includes 50% plus revenue growth. Aim for positive full-year EBITDA by mid-2025 and cash flow positivity by year-end.

• TriSalus will file a Form 12b-25 notification of late filing with the SEC related to the 2024 annual report on Form 10-K due to errors in determining stock-based compensation and timing of clinical trial-related R&D expenses in 2024. Operating results provided are unaudited and subject to potential adjustments.

Q: With respect to the launch of TriNav large vessels, where are you seeing an uptake? In TACE, are you seeing it in HCC and ICC procedures? And with TARE, are you seeing it in segmental artery procedures? And if you can break it out in terms of what percent is going to TACE and TARE.

A: Mary Szela states they're seeing TriNav large primarily in TARE more than TACE, with Medical Director Dr. Richard Marshall adding it's for larger vessel applications in low-bar administration, more in neuroendocrine tumors with larger arteries.

Q: Can you qualify or quantify at all what you're seeing in terms of current mapping with TARE and how you see the code that was issued yesterday A: Mary Szela explains the new CMS code for Medicare opens up market for those concerned about reimbursement, with commercial patients using TriNav for mapping and treatment, and they went back to CMS to get the new code as original mapping wasn't properly covered in the code Q: Can you provide us with some color on what we should be looking for in the PERIO-03 data? And related to this, should we be comparing these results to systemic chemo? Or are there other benchmarks that make more sense?

A: Mary Szela says PERIO-03 is a Phase I dose-ranging study in very sick patients, monotherapy only, not compared to chemo, waiting for final data mid-2025 Q: I was hoping to start with one on the guide. I appreciate the reiteration of greater than 50% growth for the year. But just given we're pretty much through Q1, any color you can provide on that?

A: James Young says they can't talk about Q1 specifics, but growth might be lumpy but still confident in 50% guide for the year Q: I was hoping to get a little more color around account openings. I think if you look at Q3 year-to-date in 2024, it was about 101, and then you mentioned 103 for the full year. Can you give us some information kind of in the background, maybe new sites versus closed sites?

A: Mary Szela says it was deliberate to shift focus to driving utilization in open accounts after opening many new accounts earlier, now balancing new account openings with utilization driving Q: Hi, Mary and Jim. This is Seamus on for Suraj. Congrats on the strong end of the year and thank you for taking our question. So to start, I guess, you kind of noted that earlier with the new TriNav system mapping code, it's about 25% of patients. So I guess can you help us understand kind of what percentage of that 25% were using TriNav for mapping before for those Medicare patients?

A: Mary Szela states they don't believe Medicare patients were using TriNav for mapping before as it wasn't favorable, and the new code is upside as it wasn't baked into guidance Q: Great. Thanks for taking the questions. Just you talked about the mapping being upside. Kind of what is the attachment rate of mapping the cases today in commercial?

A: Mary Szela and Dr. Richard Marshall state it's close to one-to-one on the commercial side as physicians see mapping with TriNav as beneficial for better outcomes and economic favorability