TriSalus Life Sciences, Inc. Q3 FY2025 Earnings Call

Good afternoon, and welcome to TriSalus Life Sciences' Third Quarter 2025 Earnings Conference Call. As a reminder, this call is being recorded for replay purposes. I will now turn the call over to Jeremy Feffer, Managing Director with LifeSci Advisors. Please go ahead, sir.

Thank you, operator, and thank you all for participating in today's call. Joining me today from TriSalus Life Sciences are Mary Szela, President and Chief Executive Officer; David Patience, Chief Financial Officer; and Dr. Richard Marshall, Medical Director. Ms. Szela will provide an overview of the company's third quarter results and strategy for the balance of the year. Then Mr. Patience will review the financial results for the quarter in detail. Following their prepared remarks, Dr. Marshall will join the call to help address questions from covering analysts. Earlier this afternoon, TriSalus released its financial results for the quarter ended September 30, 2025. A copy of this 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 include forward-looking statements within the meaning of federal securities laws, which are made 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 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 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. The conference call contains time-sensitive information and is accurate only as of this live broadcast today, November 13, 2025. And with that, I'll turn the call over to Mary.

Thank you, Jeremy, and good afternoon, everyone. Thank you for joining us for a review of our third quarter 2025 results. I will begin with a high-level review of the quarter and recent weeks and provide a quick update of our longer-term strategy. David will then follow my remarks to provide a more in-depth review of our financial and operational results for the quarter. We will then be happy to open the call to questions. Let's begin. I'm pleased to report that our third quarter results were strong. Revenues were $11.6 million, representing a 57% increase over the prior year quarter and a 3% sequential gain over the second quarter of 2025. During the quarter, we also continued to expand our TriNav platform, launching our TriNav FLX infusion system and advancing new clinical applications to expand our market opportunities. We also simplified our capital structure through the successful completion of our exchange offer and consent solicitation for preferred stock. Operationally, we continue to manage cash efficiently, ensuring resources were allocated strategically to advance our key priorities. We increased commercial investment to maintain our strong growth, a deliberate decision that extends our timeline to reach EBITDA positive and cash flow breakeven. Our commercial momentum in the third quarter remained strong. The commercial organization continued to drive deeper penetration within the complex liver embolization market. Bolstered by the Centers for Medicare and Medicaid Services (CMS), HCPCS code C8004 introduced in April. This new code expands coverage to include simulation angiogram or mapping procedures using TriNav, enabling interventional radiologists to utilize TriNav for other treatment planning and delivery using radioembolization. As a result, the reimbursable use of our technology within the radioembolization market has effectively doubled, supporting the broader adoption we're observing. Now interventional radiologists are able to use TriNav across the full continuum of radioembolization care. Early feedback from key accounts and users highlight the clinical and economic advantages of the expanded reimbursement, which we expect to continue driving adoption into 2026. We are reaffirming our 50% revenue growth guidance, reflecting strong confidence in our growth momentum and market opportunities. Consistent with our prior commitment, we continue to invest in long-term growth via increasing commercial resources and funding of new applications. We believe TriSalus' Pressure-Enabled Drug Delivery (PEDD) technology represents a transformative opportunity with substantial long-term value across a wide range of solid tumors and interventional treatment approaches. We continue to execute a focused strategy to expand our platform with technologies that address the complex challenges of tumor vasculature and improved delivery. Momentum across our programs remains strong, reflecting the growing clinical and commercial impact of our PEDD technology. In the last year, we launched TriNav LV, TriGuide, and the TriNav FLX, each advancing our commitment to innovation and improving therapeutic delivery precision. Expanding our product suite broadens our addressable market, strengthens physician adoption due to a technological solution for all the various vascular challenges, and extends our reach beyond the liver into new therapeutic areas. Expanding our product portfolio remains a core pillar of our growth strategy. By broadening our addressable market and delivering solutions with greater versatility and precision, we're enabling more physicians to treat complex patients and extending our reach beyond the liver into new therapeutic areas. Following the quarter, we began market evaluation of our next-generation TriNav XP, which features compatibility with larger particles and a more flexible distal tip, an important advancement for low bar liver and uterine artery embolization procedures. Although early, feedback from over 20 initial cases with key opinion leaders has been outstanding, which highlighted exceptional trackability, enhanced visualization for precise targeting, and improved professional efficiency. These advances reinforce our confidence in TriNav powered by PEDD as a platform that helps interventional radiologists address their most difficult tumor drug delivery challenges. We continue to invest in the TriNav portfolio to deepen its clinical impact to improve drug penetration, reduce complications, and expand patient eligibility. Our results this quarter demonstrate that TriNav is well positioned to become the standard of care in liver embolization for complex patients. We remain focused on strengthening the clinical evidence base, engaging closely with key medical societies, and driving commercial expansion to fully realize TriNav's market potential. As previously discussed, beyond leveraging our PEDD technology in liver cancer, we're also expanding the clinical application through the TriNav Infusion System. Yesterday, we hosted the first in a series of key opinion leader events focused on the potential use of TriNav Infusion for the treatment of uterine fibroids. The event featured Dr. Nicole Lamparello of Weill Cornell Medicine and NewYork-Presbyterian Hospital, and Dr. Francis King of Rutgers Robert Wood Johnson University Hospital and University Radiology Group. Both speakers highlighted the significant unmet need in uterine fibroid treatment and reviewed the current therapeutic landscape. In addition, enrollment continues in our PROTECT registry, a multicenter initiative evaluating PEDD for patients with thyroid nodules or goiters who are not candidates for surgery radioiodine or ablation. This study is designed to assess disease-related quality of life, thyroid function, and outcomes following PEDD-based thyroid artery embolization. As previously noted, preliminary results published in the Journal of Endocrine Society were highly encouraging, showing 100% technical and clinical success, no neurovascular complications, mild and transient discomfort in 81% of all patients, all resolved within 2 weeks, and a 73% reduction in thyroid size and importantly, normalization of thyroid function in 71% of participants. These findings reinforce the promise of this minimally invasive alternative to thyroidectomy. We also initiated a pilot registry in the emerging field of genicular artery embolization (GAE), which offers a novel minimally invasive approach to pain management and mobility preservation for patients with knee osteoarthritis. GAE has the potential to delay or avoid total knee arthroplasty in select patients. In parallel, we're preparing to launch a clinical trial evaluating TriNav and GAE as a treatment option for knee osteoarthritis, a condition affecting more than 30 million adults in the United States. The study aims to determine whether TriNav and GAE can effectively reduce pain and delay the need for knee replacement surgery. In parallel with expanding the clinical utility of TriNav, we're also advancing our efforts to begin partnership discussions to maximize the long-term value of nelitolimod across several high-value oncology indications. This transition will eliminate the vast majority of development-related expenses for nelitolimod by the end of 2025, while preserving the program's potential upside. It also allows us to focus internal resources on the near-term high-impact opportunities within our PEDD platform. Phase I studies of nelitolimod in multiple liver tumor types, which include metastatic uveal melanoma, hepatocellular carcinoma (HCC), and cholangiocarcinoma, are now complete. Enrollment has also concluded in PERIO-3, our Phase I trial in locally advanced pancreatic cancer with final data expected by year-end. Clinical study reports for all 3 PERIO Phase I dose escalation trials are in preparation with data releases anticipated in Q4. We're currently finalizing reports and data presentations to support future partnership discussions. Completion of enrollment and closure of these studies will drive a reduction in R&D expenditures in the second half of 2025, and we continue to support several ongoing investigator-initiated studies. Before turning the call over to David for a review of our third quarter financials, I want to reiterate that TriSalus remains focused on executing our near-term milestones, including advancing the TriNav platform across multiple indications focused on the interventional radiology call point, advancing PEDD solutions designed to optimize therapeutic delivery and address the full spectrum of vascular access and perfusion challenges faced by the interventional radiologist, generating and publishing new clinical and HEOR data to validate the effectiveness, safety, and economic value of our technology, enhancing operational performance in our manufacturing and improving gross margins, and also building a scalable, high-growth organization. As we look ahead to the balance of 2025 and into 2026, we're energized by our long-term vision of bringing our PEDD technology platform to a broader range of patients, improving outcomes, and redefining standards of care. TriSalus remains a science-driven organization with patients at the center of everything we do. Our progress continues to make a meaningful difference for people living with liver, pancreatic, and other solid tumors. And with that, I'll turn the call over to David.

Thank you, Mary. As Mary mentioned earlier, TriSalus delivered another strong quarter. For the 3 months ended September 30, 2025, revenue was $11.6 million, representing 57% year-over-year growth and 3% sequential growth versus the second quarter. This continued momentum reflects the exceptional performance of our commercial team and the expanding adoption of TriNav for liver embolization procedures across a growing customer base. In the third quarter, we increased the number of unique ordering accounts by 30% compared to the third quarter of 2024, adding 20 new accounts while also achieving higher utilization per account. Sequential growth reflected expected seasonal trends; a temporary dip in July was driven by lower procedure volumes followed by record levels in both August and September. The gross margin for the quarter was 84% compared to 86% in the prior year period. The modest decline was primarily due to lower manufacturing efficiency associated with newly launched products, a dynamic we expect to improve in the fourth quarter as production stabilizes. Research and development expenses were $5.2 million, up from $4.2 million in the third quarter of 2024. The increase was largely attributable to a one-time charge of approximately $2.1 million related to the closure of our clinical studies for nelitolimod, partially offset by the revision of approximately $700,000 in patent-related costs to general and administrative expenses. Excluding the one-time charge and the revision, R&D spend was down about $400,000 year-over-year. Sales and marketing expenses totaled $6.8 million compared to $6.1 million in the prior year. The increase was primarily due to higher performance-based compensation reflected by our strong commercial momentum. General and administrative expenses were $6.7 million, up from $4.7 million in the third quarter of 2024, driven mainly by the acceleration of approximately $1.6 million in noncash stock-based compensation and the revision of approximately $700,000 of patent-related expenses. Excluding the one-time accelerated stock-based compensation and revision of patents, G&A was down $300,000 year-over-year. Operating loss for the quarter was $9 million compared to $8.7 million in the prior year. The increase was primarily driven by the one-time charge related to the closure of our clinical studies for nelitolimod and the noncash stock-based compensation acceleration in the period. Cash used in operations was $3.7 million, a substantial improvement versus $11.2 million compared to the third quarter of 2024. Adjusted EBITDA loss was $5.4 million, an improvement from $7.1 million in the prior year. This includes approximately $2.1 million in one-time charges related to the PERIO study closeout. The improvement in adjusted EBITDA reflects stronger sales performance, lower underlying R&D spend, and disciplined operating expense management. Our cash burn for the quarter was approximately $3.8 million, bringing our quarter-end cash and cash equivalents balance to $22.7 million. We believe this provides us ample liquidity to fund our operations and strategic objectives. Subsequent to the quarter, we amended our debt agreement to reduce the minimum cash covenant from $10 million to $5 million, providing additional balance sheet flexibility. As Mary highlighted earlier, the preferred conversion completed in July simplified our capital structure, eliminated the 2027 preferred stock reset provision and better aligned our long-term investor base for future growth. With that, we're ready to open the line for questions.

The first question comes from Frank Takkinen with Lake Street Capital Markets.

This is Nelson Cox on for Frank. Congrats on all the progress here. I want to start with 2026. I understand you guys are not guiding for that today, but just any color you feel comfortable providing there in terms of how we should be thinking about growth in 2026. When I look at where the Street is at, there's kind of a wide range. So just wanted to give a chance if you guys are comfortable to provide more color there.

Yes, Nelson, this is David. Thank you for the question. Right now, we're confident and very excited about our current momentum, especially in the fourth quarter. So that's really our focus right now. We are maintaining our guidance thus far of the 50% growth and adjusted EBITDA positivity in the first half of next year. But other than that, we're pretty focused on the current operations of the business, and we're excited about it.

All right. Fair enough. And then kind of curious if there's any additional color you can provide outside of liver in terms of growth you're seeing in your other indications.

Yes, I can take that, Nelson. One of the things that we're doing right now is we're investing in some of the new applications that our technology can be used for. And yesterday, we had a webinar on uterine artery embolization, and we are right in the middle of our market evaluation for one of our new products, and we're really excited about it. I think this is a product that can be really meaningful for uterine artery embolization, help reduce procedural time, help reduce the amount of embolics that are used, which correlates to reduced pain. And the other important thing is just reduce the administration of embolics into the myometrium tissue, which can cause a lot of post-procedural pain. So we think this could be a major opportunity for us in 2026. We'll enter our full launch in about a week. But already, just based on the feedback and just the utilization and the market evaluation, it's been really robust. I think we mentioned too on our earnings remarks that we are in the midst of a genicular artery embolization trial. That's something that we'll continue to invest in and move even further. We have a new product launch coming in the fourth quarter, which is TriNav Advance. And this one, we think, could be really interesting for us because this is a technology where the interventional radiologist has the potential to use any microcatheter. And we think that could open up the opportunity for other different procedures. I'd like to have Dr. Richard Marshall comment on this. He's actually used this product and also used our XP and maybe you can comment on those as well, Dr. Marshall.

Thanks, Mary, and good afternoon, everybody. So I am very excited about both the XP, which is our product for uterine artery embolization that's currently in limited market release, and the feedback has been great. This will allow physicians to use a TriNav in a part of the body where they couldn't use it or it was very difficult to use previously. The same thing goes for our genicular artery embolization. So currently, we have a pilot trial going on to evaluate this. But in Q4, we'll be launching the advanced product, which will allow physicians to get deeper into these arteries with their favorite microcatheter. So we're going to be giving them the effects of a TriNav, but they're going to still feel like they're using and be able to treat patients like they normally do with their favorite microcatheter. So I think that's going to provide a lot of opportunity, especially in really small arteries and smaller parts of the body like genicular arteries, which is a growing area of treatment. I've been able to use these products. The advance, I have not used in a human yet because it's not available. But I can tell you my experience with it in pigs has been phenomenal. And I think it's going to generate a lot of excitement and expand what we can do, the number of patients that we can treat.

And the next question will come from William Plovanic with Canaccord.

As we start the year, I want to mention that the revenue for the quarter was a bit below expectations. I appreciate the comments about the cadence for August and September, which provide confidence for finishing the year, with consensus around $45 million. However, returning to the earlier question, estimates suggest over 50% growth next year, with some analysts predicting nearly 90% year-over-year growth. While I understand you may not want to comment, do you believe there is any possibility that your revenue growth could exceed 50% in 2026?

Yes, I think that's a great question. We have not provided guidance for the 2026 numbers. Those familiar with our story understand where we anticipate growth in the business. We're not ready to discuss 2026 at this time. We're very focused, and we appreciate your understanding. The first quarter results of $9 million and two quarters of over $11 million each are in line with our forecasts, and we are on track to achieve our 50% growth target, which we expect will significantly increase in the fourth quarter. September was a record month for us and marked our strongest performance ever. However, we are not prepared to comment on 2026 just yet. We remain focused and confident that we will reach our 50% growth target.

And then just a follow-up. As we consider the use cases for mapping, it doubles the opportunity. What percentage of your case mix today involves mapping? Additionally, what are you observing regarding new account penetration going deeper compared to new account additions as drivers for your growth?

Perfect. Yes, I'll take the last part. Our new account additions, we are adding about 20 accounts through VAC approval for the quarter. Again, our focus going into this year was opening a lot of accounts. Excuse me, we're already opened, and we are driving deeper penetration, as you commented. And so our utilization is continuing to grow on a quarterly cadence per account, and that is really driven by new physicians spreading word of mouth using TriNav where we used to have 1 champion. Now we have 1 or 2. And then the newer applications will play a big role as those interventional radiologists are going to be using us not just for the liver. And so to answer your question, very focused deep penetration within each account to improve utilization, and we're seeing that in the numbers, and that's what we're excited about. And I'll turn it over to Mary to talk about mapping.

Bill, thank you for the question. Mapping has been a significant driver for us in the latter half of the year. Based on our internal data from Veeva representatives, I estimate that approximately 30% of our growth is attributed to mapping. It's important to remember that the market is split between radioembolization and chemoembolization, and mapping is not performed in chemoembolization. We're achieving a two-for-one effect in radioembolization. Additionally, the introduction of a new code in April has posed some challenges, as many are still unfamiliar with it. However, with support from our reimbursement resource, Dr. Z, we have navigated these challenges, and we’re beginning to see growth accelerate. This has been very beneficial for us this year.

And the next question will come from Ross Osborn with Cantor Fitzgerald.

This is Matthew Park on for Ross today. I guess just starting off, as you initiate the genicular artery embolization study for knee OA, how do you view the broader competitive landscape developing around here? And where would you see TriNav fitting in within the potential standard of care?

GAE presents an exciting opportunity, particularly for patients, as it may minimize the need for knee surgery and directly addresses their immediate pain. We are focused on drug delivery devices, and we notice significant competition based on the types of feeds being used—whether they are resorbable or consist of different drugs. We believe our advantage lies in our ability to deeply penetrate these vessels and safeguard against off-target delivery. Dr. Marshall has been involved in our early cases and pilot study, and he will provide further insights on this topic. We think this drug delivery aspect is crucial for the procedure, regardless of what is administered into the vessels. Dr. Marshall?

Thanks, Mary. I think you highlighted some really good points. The most difficult thing about these cases is being able to deliver particles or liquid into these genicular arteries. It has to go deeply without having it go into places where we don't want it to go. Obviously, the foot is distal or downstream from the knee. And so that's what we all want to protect. TriNav, with both its flow modulation and reflux protection accomplishes both of those. So this procedure is already being performed with traditional microcatheters. The interest that we've received so far and the success that we've seen is that physicians do an angiogram with the TriNav and they say they can see vessels a lot better. Then when they deliver their microspheres or their liquid embolic, they can push it in much further without having to worry about non-target embolization. So they feel safer and more confident. We've got some other positive feedback that we're going to publish in the near future about how we can treat multiple sites from one injection. I think that's going to distinguish this catheter from the traditional way of treatment; it's going to allow physicians to do this procedure faster and better.

Got it. That's super helpful color. And then maybe one for David. So on gross margins, you called out some headwinds in the quarter driven by these newly launched products. I guess how should we think about the cadence of gross margin over the next couple of quarters and when you would kind of expect these manufacturing efficiencies to come back in?

Perfect. I think the short answer is the fourth quarter will see an uptick. We've thrown a lot at our manufacturing team with 4 new products and 8 new SKUs in 1 single year, but we're proud of kind of where we've evolved our processes, our procedures and our lot sizes to really scale efficiently. So we should see normalized gross margins here in the fourth quarter, and then expanding early next year as well.

And our next question will come from Carl Byrnes with Northland Capital Markets.

Congratulations on your progress. Regarding TARE mapping, what have you experienced in converting existing TARE users with TriNav to mapping? I understand there's an educational aspect related to the new HCPCS code, the C8004 code. Can you quantify that at all? You mentioned a 30% revenue growth for mapping, but do you have any insights on that?

Yes. The data I have is what I shared that comes from Veeva. I can only provide anecdotal information. Maybe Dr. Marshall can respond. Dr. Marshall, what are your thoughts on this? From my impression, physicians prefer to use the same technology for mapping that they use for treatment. It's important that what is observed in the initial session aligns with how the dose is defined and how the patient will be treated. This has been a significant message for us as we engage with physicians. The conversion has been substantial because they typically use one method and want to stick to that for treatment. Now we're converting two catheters instead of one, which is driving most of the positive outcomes. However, I don't have definitive data on this. Dr. Marshall, would you like to share your insights?

I agree. I want to emphasize that physicians prefer to use the same catheter for both mapping and treatment. They don't want to use one catheter for mapping and a different one for treatment because once they administer Y90 or any radiation, it cannot be undone. They need it to perform as expected. Physicians have been quite impressed with the angiography quality from TriNav due to the effective way contrast moves through and pressurizes the arteries, which enhances visibility. A lot of the feedback suggests that using the same catheter for both mapping and treatment allows them to see better, and in some cases, they are able to identify more tumors. The response has been overwhelmingly positive. However, we still need to educate some physicians about the catheter's use and that it is covered by insurance, Medicare, and Medicaid under a CPT code.

Great. Very helpful. And then just one quick follow-up. What are you seeing with respect to adoption of LV and FLX and in what procedure specifically?

I can provide insights on this. We have centers that have fully transitioned to FLX and are very satisfied with the catheter, preferring to use it exclusively. These centers often focus on more selective treatments, dealing with smaller areas of the liver and arteries that are farther away for the catheter to navigate. They value the catheter’s ability to track effectively over longer distances. Others appear to be more hesitant, but we've seen many users switch to FLX, which has been very positively received. LV has been beneficial in situations where TriNav excels, particularly in treating larger areas, such as half of the liver, which we refer to as low bar treatment, or an entire liver lobe. The valve in that case is larger. This is especially relevant for patients suffering from primary liver cancers like hepatocellular carcinoma or those with metastases that have significant blood flow, such as neuroendocrine tumors. The larger arteries involved make this a suitable option in these cases, allowing for quicker injection of more contrast and particles because of the larger catheter. Users have found this very advantageous. Beyond the liver, we've observed TriNav FLX being used effectively in thyroid arteries due to their complex paths. The same goes for uterine artery embolization, although we anticipate significant growth there with the newly released XP catheter, which is specifically designed for that purpose and has been well received thus far. I hope that answers your question.

Yes, that's very insightful, Dr. Marshall. I want to mention that we saw FLX perform better than we expected, as it currently makes up around 35% of our product mix. TriNav accounts for 50%, while the large category is about 15%. We are witnessing continuous month-over-month growth with FLX, and it has been challenging for us to keep up from a manufacturing standpoint. I'm also looking forward to seeing how XP performs, as it has caused some manufacturing difficulties. It's important to note that we have a single price for all our products, which relies on the physician's use and the type of vessel tortuosity. This creates some inefficiencies in our manufacturing processes, as it's tough to estimate the changes on a monthly basis. We anticipate that this will stabilize over the next few months in 2026.

And our next question will come from Justin Walsh with JonesTrading.

It's great to see you exploring different use cases for TriNav. I'd love to hear your thoughts on the long-term mix of uses if some of these indications are more likely to be more significant than others.

That's a great question. Initially, when we examined our procedural code, we identified about 40 different embolization procedures that we could consider. We chose those that offer the most immediate benefits to patients and the market. For uterine artery embolization, market estimates range from around 110 to 250, representing a notable opportunity for us. However, we believe that gynecological artery embolization could possibly rival the liver market due to patient volume and excitement surrounding its use. During our discussions with a large group of interventional radiologists and orthopedic surgeons, they expressed interest in employing this procedure post-surgery for patients experiencing significant pain two days after their operation, which could enhance their recovery and physical therapy. This market has the potential to be comparable to or even surpass the liver market. Dr. Marshall may provide more insights on this. The thyroid market also shows potential similar to uterine artery embolization, but we have many avenues to explore. We're currently focused on these opportunities and believe this embolization approach can significantly benefit patients by making surgical procedures less invasive, more cost-effective for payers, and potentially combinable with other treatments. Dr. Marshall, would you like to add anything?

Yes. We're talking about the delivery of embolics right now, and we still have more room to grow in the liver, obviously. But I think the elephant in the room is genicular artery embolization, just the number of patients that have osteoarthritis. With a population that's aging, the number of knees that are going to need to be treated in the future is going to grow quite a bit. We have a great solution for that, and that's why I think it's going to be a huge area of growth for us.

I show no further questions in the queue at this time. I would now like to turn the call back over to Mary for closing remarks.

Thank you, everyone, for joining the call and all your active support and interest in the company. We really appreciate it. Thank you again.

This concludes today's conference call. Thank you for participating. You may now disconnect.