TLSI - NASDAQ

Good morning, and welcome to TriSalus Life Sciences Fourth Quarter and Full Year 2024 Earnings Conference Call. Currently, all participants are in a listen-only mode. We will be facilitating a question-and-answer session toward the end of today’s call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Jeremy Feffer.

Thank you all for participating in today's call. Joining me today from TriSalus Life Sciences are Mary Szela, President and Chief Executive Officer; and James Young, Chief Financial Officer. Earlier this morning, TriSalus released financial results for the fourth quarter and full year ended December 31, 2024. A copy of the press release is available on TriSalus' website. Before we begin, I would like to remind you that management will make statements during this call that includes forward-looking statements within the meaning of Federal Securities Laws, which are pursuant to the safe harbor provisions of the Private Securities Reform Act of 1995. Any statements contained in this call other than the statements of historical fact are forward-looking statements. All forward-looking statements, including, without limitation, statements relating to our sales and operating trends, business and hiring prospects, financial and revenue expectations, the timing of the filing of our annual report and Form 10-K, and future product development and approvals are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties, including the impact of macroeconomic conditions and global events that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 10-Q on file with the SEC and available on EDGAR and in our other reports filed periodically with the SEC. TriSalus disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, March 27, 2025. And with that, I'll turn the call over to Mary.

Good morning, everyone, and thank you again for joining today's call. In 2024, TriSalus executed decisive strategic moves to position the company for long-term success. Recognizing the strong commercial potential of our pressure-enabled drug delivery technology, driven by its favorable reimbursement advantages, pipeline expansion opportunities, and broader utilization in new clinical applications, we prioritized our technology platform, while preserving future upside for nelitolimod through a potential partnership and a focused pancreatic indication strategy. This strategic shift significantly reduced R&D expenses while establishing a clear path to EBITDA positivity by mid-2025 and cash flow positivity by year-end. Despite a challenging economic environment, TriSalus maintained strong commercial momentum, expanding our PEDD technology into new clinical applications. Today, I'll walk through our quarterly results and highlight our achievements over the last year, which has set the stage for continued growth. Notably, we achieved 44% growth in the fourth quarter and 59% operational growth for the full year, marking another strong quarterly performance in a high-growth year. We remain committed to executing our growth strategy, which includes advancing our pipeline, expanding PEDD clinical applications, improving our manufacturing efficiencies and gross margins, and evolving our organization to sustain high growth. We are confident that these efforts will position us to drive 50% plus top-line revenue growth and in 2025, an even greater patient impact and financial success in the future. Now let me outline the 2024 accomplishments. TriSalus achieved $29.4 million in net sales, reflecting a 59.4% growth over 2023, reinforcing our status as one of the fastest-growing med tech companies. TriSalus focused on using our PEDD technology to improve outcomes for complex patients. Clinical studies in TACE and TARE demonstrated that our technology approach enhances therapeutic delivery while reducing off-target effects on healthy tissue. Our health economic and outcome research study highlighted that TriNav is predominantly used in high disease burden patients, leading to comparable outcomes to those with lesser disease burden and better transplant success rates. TriSalus increased the number of unique ordering accounts by 43% year-over-year from 199 to 284. Account utilization also improved with average units sold per ordering account rising 10% from 12.3 to 13.5 units. Additionally, we opened up 103 new accounts, nearly doubling the 55 new accounts added in 2023. These new accounts contributed 19.5% of the total 2024 sales. The PROTECT registry study is evaluating TriNav for non-malignant thyroid goiters and nodules. The study is enrolling 100 patients across over 10 academic sites, non-malignant thyroid goiters and nodules represent a market of approximately 50,000 annual procedures and a $400 million incremental opportunity for TriNav. The procedure is already eligible for our existing HCPCS reimbursement code, streamlining future adoption. We also published additional real-world HEOR studies, leveraging our 300 million patient records, which covers over 98% of US payers. The latest analysis, which was an additional year, compares 603 PEDD patients with 16,210 non-PEDD patients. These results confirms improved patient outcomes, including lower post-procedure fatigue rates, better chemotherapy delivery, and fewer complications in HCC and TARE patients. We also received recent news from CMS that they issued a new code, HCPCS code C8004 for simulation or mapping procedures using TriNav. This now becomes effective on April 1, 2025. This reimbursement code ensures financial support for clinicians using TriNav in Medicare treatment planning. The launch of TriNav LD infusion system and TriGuide guiding catheter expanded our PEDD portfolio. These innovations optimize therapeutic delivery, improve procedural efficiency and expand our addressable market, and offer physicians a full range of vessel size for any embolization procedure. Additionally, TriSalus completed Phase I clinical trials for nelitolimod in uveal melanoma liver metastasis, HCC, and intrahepatic cholangiocarcinoma utilizing PEDD. We are actively seeking strategic partnerships to advance this program in uveal melanoma liver metastases. Additionally, we completed enrollment in the PARIO-3 Phase I trial investigating nelitolimod in locally advanced pancreatic cancer. Final data is expected mid-2025, and we will determine next steps based on those results. TriSalus also secured up to $50 million in debt financing from OrbiMed to support TriNav growth initiatives with $35 million accessed to date. Our cash runway extends through 2025. And our Westminster site supported TriNav large and TriGuide launches in Q3 2024 and is preparing for launch of TriNav 2.0 in the first half of 2025. A clean room expansion is set for Q1 2025, and this will increase manufacturing capacity. TriSalus is poised for continued growth in 2025, driven by our strategic priorities, which include: deeper penetration of the complex liver embolization market; expanded reimbursement for radioembolization mapping, the launch of a more trackable TriNav 2.0, enhanced health economic and outcome research data, and new clinical study presentations at SAR and our Phase I clinical trial data reveal for nelitolimod in combination with our novel pancreatic infusion technology. We believe TriNav has the potential to become the standard of care for complex embolization patients. Our focus will remain on strengthening clinical evidence, executing targeted educational initiatives, and working toward inclusion in society guidelines. I'll close by reiterating our 2025 guidance, which reflects 50% plus revenue growth, along with positive full-year EBITDA and cash flow in the second half of 2025. We are a science-driven company with a steadfast commitment to keeping patients at the center of everything we do. Our advancements make a meaningful difference for those suffering from liver, pancreatic, and other solid tumors. In 2024, we've made significant progress in expanding the commercialization of TriNav, advancing our technology pipeline, including nelitolimod in combination with TriNav, and strengthening our overall operations. With a focus on operational and strategic excellence, I'm confident in our ability to drive continued growth for TriNav, advance our pipeline, and deliver both short-term and long-term value for our shareholders. Most importantly, my confidence comes from our team, their dedication to patients, commitment to our mission, and relentless pursuit of innovation. I want to express my sincere gratitude to our employees and shareholders for their unwavering support. I look forward to sharing future updates on our progress and impact. Now I'll turn it over to our CFO, Jim Young.

Good morning, everyone, and thank you, Mary. As noted in our press release, TriSalus will soon file a Form 12b-25 notification of late filing with the SEC related to the company's annual report on Form 10-K for 2024. This filing provides the company an extension of up to 15 days to file its annual report. If the company files its annual report within such 15-day period, the annual report will be deemed to have been filed timely. The company filed Form 12b-25 due to errors identified in determining stock-based compensation and the timing of clinical trial-related R&D expenses in 2024. As a result, the operating results provided on the call today are unaudited and subject to potential adjustments. Despite this administrative delay, TriSalus delivered a strong operational performance in the fourth quarter ending December 31, 2024. Revenue driven solely by the continued success of the TriNav device in the U.S. reached $8.3 million, representing a 44% increase compared to the same period in 2023 and a 12% sequential increase from the third quarter. As illustrated on Slide 1, TriSalus has maintained a robust growth trajectory, achieving a compound annualized growth rate of approximately 50% since the product's launch in 2020. In terms of full-year revenues, in 2024, we have reached $29.4 million, a 59% increase from the prior year. These results can be attributed to several factors, including the adoption of TriNav in new accounts, increased utilization of existing accounts, and the continued expansion of our sales force, all of which have led to an increase in our market share for 2024 to 9% of the liver, TACE and TARE procedures. These factors as well as our favorable reimbursement and real-world evidence data allow us to forecast 2025 growth in excess of 50%. In 2024, we captured 103 new hospital accounts year-to-date. Our account utilization reached 13.5 units per account, an increase of 1.2 units or 10% over the prior year. We are proud to report a robust gross margin profile of 85% in the fourth quarter of 2024 and 86% for the full year compared to 90% in the fourth quarter and 86% for the full year in 2023. We believe our facility in Westminster, Colorado has the capacity to support our growth over the next five years with minimal capital investment. In terms of our investments in research and development, expenses for the fourth quarter of 2024 totaled $3 million, a decrease of 62% from the fourth quarter of 2023. Full-year R&D expenses amounted to $17.7 million, reflecting a 41% decrease from the corresponding period in 2023. We expect our clinical costs in 2025 to continue to decrease due to the completion of nelitolimod patient enrollment in all PERIO studies. In terms of sales and marketing, in the fourth quarter of 2024, we invested a total of $7 million, a 25% increase from the fourth quarter of 2023. Full-year sales and marketing expenses reached $25.8 million, which is a 52% increase from 2023. General and administrative expenses for the fourth quarter of 2024 totaled $4.7 million, representing a decrease of over 22% compared to the fourth quarter of 2023. Full-year general and administrative expenses of $18 million were 24% less than in 2023. Our operating losses for the fourth quarter of 2024 totaled $7.6 million compared to losses of $14.2 million in the fourth quarter of 2023. Year-to-date losses in 2024 amounted to $36.2 million compared to losses of $54.5 million in 2023. The decreased losses in 2024 can be attributed to increased gross margins resulting from increased TriNav revenues and reduced operating expenses in research and development and general and administrative expenses, partially offset by increased investments in sales and marketing. At year-end, we have $8.5 million of cash and cash equivalents. In addition, we drew an additional $10 million from our OrbiMed debt facility in the first quarter. This amount as well as other additional existing sources of liquidity provide us sufficient liquidity to fund operations throughout 2025. And now I'll turn the call back to Mary for closing remarks.

Thank you, Jim, and to all of you participating in the call today. With that, I'll open up the floor for any questions you may have.

Thank you. [Operator Instructions] Our first question comes from the line of Carl Burns with Northland Capital Markets. Your line is now open.

Congratulations on the progress and the results and thanks for the question. 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. Thanks.

Sure. I'll take this. And I'm also going to have our Medical Director, Dr. Richard Marshall, jump in as well. I think he can talk about just the utilization between TACE and TARE. But mainly, what we're seeing is a lot of the TriNav large right now being used for, as you know, large vessels in low bar administration as opposed to super selective and just larger vessel size, vessels that are 3.5 to 4, people will move to the larger vessel. Right now, we're seeing it primarily in TARE more than TACE. But I'll have Dr. Marshall actually comment a little bit more about what he's seeing across the country as well.

Thanks, Mary. That's exactly right. We are seeing an increased use in larger vessel applications, which are broader treatment areas. So more low-bar applications. Patients with neuroendocrine tumors tend to have larger arteries because those tumors require more blood flow. So personally, I'm using it more frequently in that diagnosis.

Got it. Thanks you. That’s very helpful. And then I'm wondering if you can 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 [Multiple Speakers]

Yes. So let me start with -- so the code that was issued from CMS was for Medicare. I will tell you that we have -- people are using TriNav for both mapping and treatment in commercial patients, and we see that pretty consistent. However, there are accounts that are concerned that because they can't get appropriate reimbursement in Medicare, they would map with just an endhole catheter and do treatment with TriNav. And that's what actually caused us to go back to CMS. In fact, one of our analysts, John Young from Canaccord actually read through the detailed coding language and pointed it out to us, and he was correct. We went back to CMS in August, and we showed them we had thought when we worked with CMS originally that mapping was included in the original code, our C9797. But if you look at the specific coding language, it needed to be separate and different. And so we went back to CMS. They agreed. We felt that we both made a mistake and they agreed to issue a new code. And so now with the new Medicare code, we'll be able to address those people who were concerned about being able to use it in Medicare patients, too, and now we'll be able to have them use it in both mapping and in treatment. So now we'll be able to get the full market. About 74% of our payer mix is commercial. So we didn't have an issue with mapping in those patients, but we did not have mapping in the Medicare patients. So it opens up about another 25% of the market. And essentially, what CMS did is our current reimbursement for treatment is unaffected. What they did is they wanted to make sure they gave us a new code that covered the cost of TriNav. So the hospital's costs were fully covered. Does that helps.

Absolutely. That’s great. Thanks so much.

Thank you. Our next question comes from the line of Justin Walsh with JonesTrading. Your line is now open.

Hi. Thanks for taking the questions. 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?

No, I can take that. Just to remind everybody, this is a Phase I dose-ranging study in very sick patients. These were patients who were post third line, fourth line, and it was monotherapy only. So this won't be compared to chemo. And what our goal was, this was the first time we ever actually used our new technology that delivers therapeutics through the venous vasculature into the pancreatic tumor. So the goal of the Phase I study was, number one, is this technology successful? Do we feel like it's safe? And I think we are very, very comfortable with that. We did close to 40 different infusions with this and the technology works. The results that we're comparing and waiting for is just seeing how patients progress on therapy. And right now, I don't have the final results. Patients were enrolled all the way up until December. And so the inclusion criteria that these patients minimally had to have more than six months of life expectancy. So we want to ensure that patients are on therapy and exposed to nelitolimod for minimally six months. So we're waiting for those final patients and that data to come, and then we'll close the database and hope to reveal that in the middle of the year. Does that help?

Yes. Yes, it does. And I'm just wondering if you can provide any commentary, obviously, not specific details, but just the level of interest that you're seeing in your partnership discussions for nelitolimod in the UMLM patients.

Yes. So it's interesting. I just came back from a big meeting where I had an opportunity to talk to quite a bit of pharma companies and I'll tell you, I think there was quite a bit of interest, and it was mainly around the fact that nelitolimod has impact in terms of reducing myeloid-derived suppressor cells. We have not shared data with them yet. We're still closing the database and finalizing the CSR. We hope to do that in the next month or so, and then we'll set up all of our meetings for people to review. So I was actually surprised. I thought there was a lot more interest than what I imagined.

Great. Thanks for taking the questions.

Thank you. Our next question comes from the line of Frank Takkinen with Lake Street Capital Markets. Your line is now open.

All right. Thanks for taking the questions. 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? Obviously, the OrbiMed drawdown gives us some insight into that. But given we're pretty close to the end of the quarter, any help on Q1 and then the cadence throughout the rest of the year?

Jim, do you want to take that question?

Sure. I can take that. Obviously, we can't talk about Q1 at this point, of course. But I wouldn't expect it to be 50% every single quarter. It might be a little bit lumpy. But at this point, we still believe there's a pretty solid opportunity for our 50% guide. So we're still happy about it for the year.

And then maybe just on the second one, 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? And then any insight to kind of why that was only two new additions quarter-over-quarter from Q3 to Q4?

Yes, that was very deliberate, actually. I think we spent a lot of time in the latter part of 2023 and the early part of 2024 to opening up new accounts. And what we wanted to do was shift now to ensure that we are driving utilization in those open accounts. We had opened up so many accounts just the timing for our reps to go back to an open account, we weren't really driving the utilization that we needed to. So now what we're trying to do is take a much more balanced approach. I think we have quite a number of new accounts opened. We've gotten them through the VAC approval. Our big focus is driving utilization in those accounts. We'll still have a cadence of opening up new accounts, and we'll do that. It won't be the magnitude of that what we did in 2022 and 2023 and 2024 because we're at close to 284 accounts now that have been opened through VAC. There's about 400 hospitals that are really our top targets. Our goal right now is to drive utilization.

Okay. That’s helpful. Thank you.

Thank you. Our next question comes from the line of Suraj Kalia with Oppenheimer & Company. Your line is now open.

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? And what is, I guess, remaining? And what was baked into the guide, so to speak? And is there potential upside from this? Just trying to understand those kind of dynamics.

Yes. We don't think people were using it for Medicare patients because clearly, it was not favorable for them. So we don't believe they were. We know that patients, commercial payers were paying for mapping very successfully. And those customers were using it for both mapping and treatment. We did not bake mapping into our guidance at all. So we believe this would be upside because we didn't know if we were able to get a code or not. We were pretty pleased that CMS, this is -- I was very, very surprised and thankful to them because we went to them in August, and they issued a new code by April. That's really incredibly and remarkably fast for CMS having worked with them for over 30 years. So we were quite surprised that they issued it so quickly. We didn't think that this would happen until the end of the year, and that's why we didn't include it in our guidance. So we think this will be upside for us.

Got it. Appreciate that, and that's very helpful. And then just one more from our end. On the DELIVER trials, anything other than PROTECT in the first half of this year, and for DELIVER, I think when should we expect kind of full enrollment?

So maybe I'll have Dr. Marshall talk about PROTECT. We're both heading off to SIR. We have -- I don't want to talk through what we plan to do some other clinical studies and that we're just finalizing those details at SIR, and then we'll be announcing those shortly, but there are several other applications that we're going to be rolling out in the second half of the year. But Dr. Marshall, do you want to comment on PROTECT?

Yes. So our PROTECT registry, which is looking at thyroid artery embolization using the TriNav catheter is open and enrolling. We have enrolled eight patients so far. We are adding additional sites. Currently, we have one site open to enrollment, and we hope in the next few weeks to have at least one additional, if not multiple, enrolling. So I think the enrollment is going very well for that. We have planned for a one-year enrollment period for our 100 participants, but I think we're going a little bit faster than that predicted clip.

Thank you. [Operator Instructions] Our next question comes from the line of William Plovanic with Canaccord Genuity. Your line is now open.

Great. Thanks. Good morning. Just first question for me. Just you talked about the mapping being upside. Kind of what is the attachment rate of mapping the cases today in commercial?

We think it's pretty close to one-to-one on the commercial side because one of the things that we educate physicians on, and I'll have Dr. Marshall talk about it, just mapping with the same technology is just you're going to get better outcomes. And it's also economically favorable for the accounts to do that. And so based on the information that we see, Bill, we see that as pretty -- people are mapping with both with TriNav as well as treatment. I don't know, Dr. Marshall, you want to comment on that? Just that's something that people -- if they can, they'd like to do that. They want to use the same technology.

Yes, I think that's exactly right. I think it's great to -- the whole point of mapping is to predict what's going to happen when we deliver a high dose of radiation. So the more we know about it and the more we can replicate it, the better it's going to be. There are still some people who believe that they can map with an end hole and then treat with the TriNav. We've done -- I think we've got a really good set of data that proves that we have correlation with mapping and treatment. And now that we have this CPT code, I think anybody who is hesitant, now they know that there is an approved code for it. They're not going to be losing anything on the mapping procedure, and they're going to get better prediction of tumor doses and really more importantly, the nontarget normal liver doses, which we all want patients to live as long as they can. We don't want to treat any more of their liver than needed. And so I think we have a good set of data supporting how we can help that.

Great. Thanks. And then on pancreas, so we'll get the data sometime probably around the third quarter, it sounds like. And then is the next step, to Mary, a pivotal trial? Or is it a Phase II kind of have to do another trial to figure out somewhat more specifics on whether it's dosing or treatments or what have you? And then is that something that you're going to go alone or you plan on partnering?

Those are all really good questions, Bill. I don't have answers for right now. I mean we're right in the throes of -- we don't have the final data set, but we have a pretty good idea, and we're kind of going through all those machinations right now of what that would look like. I think based on what we're seeing right now, it probably would be a Phase II, Phase III trial. And we haven't made a decision on whether that would be something we would do alone. We think that would probably make sense to do with a partner. And so -- but we'd like to get the data first.

Okay. Thanks for that. And then just on the 10-K delay. So you're working through, Jim, with the noncash stock-based comp and then some of the R&D. Just where are you in that process? It sounds like you're right at the end of it. It was something that came up in the final year audit, and you've kind of been working on this a while. But how do we think about just where you are in the process on that? And then in terms of -- obviously, you have disclosed it because of the delay. But in terms of materiality, is this something that's less than 10% of your operating expenses or more -- I mean, what's the magnitude of kind of the changes we might expect to see for the year?

Yes. Those are perfectly fair questions, Bill. And as you can understand, being a former CFO yourself, I know I really can't get into details. Obviously, the audit is being completed. It's a very detailed audit. At this point, we're hoping the numbers don't change at all. If they do, we will certainly inform the market and be very transparent about that. But obviously, I can't comment on what might change until the audit is complete. So we are very aware of the importance of this. We are working very hard. And our -- we have new auditors this year. They're doing a great job. They're looking very closely at everything, which helps us and it's great. So we're going to keep working to complete that. And once the results are done, we will -- if anything changes from what we published today, and I hope it doesn't, but if it does, we will be extremely transparent with the marketplace. And to comment on the magnitude of what it might be, I really can't at this point. I think you probably understand.

Yes. And then just to kind of circle back on one of the other questions asked. I mean you've guided to 50% year-over-year growth. We've seen a deceleration into kind of the 40s for the past couple of quarters. Is it kind of that's what you -- is there some reason that it sounds like you're kind of back half loading the year for 2025? Is this because all the accounts you brought on in the first three quarters, it takes them six or nine, 12 months to get going? I'm just trying to kind of understand, go back to that cadence question.

Yes. Mary, would you like me to take that one?

Yes, if you want, go ahead.

Sure. Yes. I think, Bill, you hit it kind of on the head. We have a lot of new accounts, as you've seen. And it takes a little while to drive the adoption and to drive things -- drive more doctors within the institutions using the product. So yes, if I had to sit here right now, I would tell you it will likely be a bit more backloaded. You've also got greater opportunities with -- obviously, with mapping and other things. But -- so I would not be surprised to see the 50% for the year being somewhat back-end loaded a little bit. But we think we still have a great deal of opportunity. We have very low market share, and we have a number of really positive catalysts coming. So including the new accounts that you referenced.

Great. Thanks for taking my questions.

Thanks, Bill.

Thank you. And I'm currently showing no further questions at this time. I'd like to turn the call back over to Mary Szela for closing remarks.

Well, thank you, everybody. I really appreciate your time and insights and questions. Thank you.