Third Quarter 2026 Earnings Call - TRISALUS LIFE SCIENCES INC

Thank you for standing by. My name is Kate, and I'll be your conference operator today. At this time, I would like to welcome to the Tricellus Live Appliances third quarter 2026 earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like your answer question during this time simply press star followed with the number one on your telephone keypad. If you'd like to withdraw your question, press the star key. Thank you. I would now like to turn the call over to Mary Zella, CEO. Please go ahead. Good morning and thank you for participating in today's call. Joining me from Trisalis are Mary Zellas, President and Chief Executive Officer, David Patience, Chief Financial Officer, and Dr. Richard Marshall, Chief Medical Officer. Earlier today, Trisallas issued a press release announcing financial results for the quarter ended September 30, 2026. A copy of the press release is available on the Investor Relations section of the company's website. Before we begin, I'd like to remind you that management will make remarks during this call that include forward-looking statements within the meaning of federal securities laws and that these are being made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. These statements involve material risks and uncertainties 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 description of the risks and uncertainties associated with our business please refer to the risks factors section of our forms 10q and 10k on file with the sec and available on ed curve as well as our other periodic filings this conference call contains time sensitive information and is accurate only as of the live broadcast today november 10 2026. trisalis 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. And with that, I will turn the call over to Mary. Good morning and thank you all for joining us. The third quarter marked an important period of growth and advancement for Trisalis. We drove increasing revenue both year over year and quarter over quarter as our commercial expansion continued and account utilization improved. In addition, in September, we received FDA clearance for Trinav Advance, enabling us to expand our portfolio looking forward. Trinab Advance extends our pressure-enabled drug delivery approach, called PEDD, to small distal vessels through the microcatheter of the physician's choice. These are vessels that Trinap technology could not previously fully address. With Trinad Advance, we've we now can address the full range of vessels encountered in liver embolization procedures. That means interventional radiologists can keep their preferred workflow while patients still benefit from PEDD. We are now preparing for a limited market release of trying to have advanced to gather early clinical and customer feedback before a broader launch. Milestones like this matter because of the problem we set out to solve. Catheter-based oncology drug delivery has changed very little in decades, even as therapies themselves have advanced dramatically. TRINAV was designed to close that gap, enabling interventional radiologists to deliver therapy to the tumor with enhanced perfusion, greater precision and concentration, and avoidance of off-target delivery. Across liver embolization and the additional indications we're pursuing, we see a U.S. addressable market of approximately $2.5 billion, and we're still in the early stages of capturing it. Turning back to our results, total revenue for the third quarter was $12.9 million, up approximately 11% from $11.6 million in the prior year period, and up approximately 13% sequentially from $ 11.4 million last quarter, driven by increasing adoption of TRINAV. While growth came in below our expectation, this reflects the timing of our commercial organization transition and new account ramp, in addition to a faster-than-anticipated shift towards super-selective Y90 administration in small distal vessels, a trend we are watching closely and preparing to address through the launch of TriNav Advance. Looking forward, our plan to accelerate growth starts with our commercial organization. As a reminder, we more than doubled our footprint over the first half of the year to better capture the full scope of the opportunity in front of us. We continue to believe this was the right decision for the long-term growth of Trisalis. Performance in our existing territories continued to grow, and the shortfall relative to the plan in Q3 was concentrated in our new expansion territories, where new representatives are taking slightly longer than anticipated to reach full productivity. As these representatives continue to build relationships with interventional radiologists and integrate TRINAB into established procedural workflows, we expect their productivity to to steadily improve. In addition, during the third quarter, we saw a faster-than-anticipated shift towards super-selective Y90 administration in small distal vessels, a trend that accelerated beyond what we observed in the first half of the year and that we could not fully address until the recent clearance of Trinav Advance. With Trinave Advance, we now have a solution and have access to those procedures. Even with these dynamics, we're already seeing early signs of progress as our new sales funnel builds. In the third quarter, the number of accounts ordering TriNav increased double digits year over year, and September was our strongest month of the year for both ordering accounts and total units sold. Territories led by our newer representatives also grew unit volume sequentially, demonstrating a positive, albeit slower-than-expected, trend line. We are focused on converting procedures to use TriNAP within this growing account base and improving productivity across our expansion territories, and we believe our team is well-positioned to drive growth acceleration as we move into 2027. We're also encouraged by recent changes in the reimbursement landscape. On November 4th, CMS published its calendar year 2027 final rules, which include two updates that were favorable for Trisalis. First, in the calendar year 1027 Hospital Outpatient Prospective Payment System, or OPPS, final rule, the Centers for Medicare and Medicaid Services, CMS, finalized the reassignment of HCPCS code C8004, the Y90 simulation, or known as mapping angiogram, from APC 5193 to APC5194, aligning it with C9797, which is already assigned to APCC 5194. Based on the final rule, the national Medicare payment for procedures billed under C8004 will increase from approximately $11,874 to approximately $20,910, an increase of approximately 76%, effective January 1, 2027. Our core hospital payment is also maintained. C9797, the PEDD embolization procedure, remains in APC 5194, with payment increasing from approximately $18,729 in 2026 to approximately $20,910 in 2027, and the catheter code C1982 included in the procedural payment. Second, CMS established national pricing for G0577, the new code for PEDD embolization in the physician office setting, commonly referred to as an office-based lab or OBL, at approximately $13,788 per procedure, up from approximately $12,300 in the proposed rule. The new national rate is effective January 1st, 2027, replacing pricing previously set by each Medicare contractor. Treatment for patients with certain liver cancers, including both case and tear procedures, continue to migrate from traditional hospital settings into OBLs, which offer patients more accessible, community-based care with shorter wait times and more flexible scheduling. We believe national pricing for G0577 will meaningfully expand access to PEDD in this growing site of care and give clinicians more flexibility in where and how they practice. These decisions recognize the resource intensity and distinct mechanism of TRINAP-enabled procedures and provides a stronger reimbursement foundation for hospitals as we continue to expand adoption of TRINAB. Taken together, these decisions give PEDD a payment path in every site of care, including hospital outpatient, ambulatory surgery center, and the office-based lab, heading into our 2027 OBL launch. Our second priority remains demonstrating and validating the value of PEDB to drive greater awareness and adoption. As we continue to build our evidence program, we've organized it around three questions that ultimately determine whether a physician in the site they practice in adopts a new technology. First, TRINAV, does it perform better than what I use today? Second, which of my patients benefit the most from TRINAB? And third, does It make economic sense for my institution to adopt TRINAF? Each of our studies is designed to answer one of these questions, and they build on one another. We use real-world and retrospective data to identify signals cost-efficiently and confirm those signals in rigorous, prospective, head-to-head studies at leading academic centers. Today we have 11 active studies across 27 clinical sites with more than 400 patients treated with Trinav. Let me start with the first question. If trying to have better than standard of care, this is where we are investing most heavily. We view the liver embolization market as three distinct segments, hepatocellular carcinoma, or HCC, liver metastases, and neuroendocrine tumors. Our strategy is to win in each one, and to do that, we're building a foundational perspective study in each segment that compares trying to add head-to-head with the standard microcatheter. In liver metastases, our pressure study at Stanford is a randomized study that compares TRINAV with standard delivery in tear, measuring tumor-absorbed dose, response rate, and disease control. In neuroendocrine tumors, we are launching a multicenter taste study in collaboration with University of Pennsylvania, a recognized leader in both liver embolization and neuroendocrine tumor care. It compares Trinav head-to-head with a standard microcatheter and expands an earlier pilot study that showed positive results for Triniv. In HCC, we have two retrospective studies underway examining Trinib-delivered tear. These findings will inform the design of our prospective tear study comparing tumor response with Trinab versus a standard microcatheter. Physicians have told us tumor response is the endpoint that matters most in their decision to adopt. We look to initiate both the neuroendocrine and the HCC studies by year-end. Together with pressure, these three studies are designed to give physicians rigorous comparative evidence across every segment of the liver market. Our completed studies add to this foundation. At Massachusetts General Hospital, the randomized PETR study evaluated Trinav's effect on the tumor-to-normal ratio in HCC and hypovascular tumors and has been submitted for peer-reviewed publication that should be published this year. We believe its publication can be a meaningful commercial catalyst. Underpinning all of our evidence generation initiatives is our commitment to patient safety. It's worth noting that since the initial launch of Trinav in 2020, we have a reportable safety event rate of just 0.02% across nearly 20,000 device patient uses. This is a tremendous validation of the consistency and safety of Trinaf. That brings me to the second question. Which patients benefit most? Showing that Trinaf performs better is the foundation. Defining where it performs best helps physicians select the right patients and move PEDD from an option to a routine part of their practice. At MD Anderson, PREDICT continues to enroll. It's a prospective study of PEDT in hypovascular tumors, a population that is difficult to treat with a standard microcatheter, and we continue to expect enrollment to take approximately 12 to 18 months. Our two retrospective studies of TRYNAB-delivered TAER and HCCs are progressing, with analysis ongoing in one and the manuscript being finalized in the other. They're generating cost-efficient outcome evidence in target HCC populations and are informing the design of our prospective HCC study. Our landmark HUR study, the largest PEDD study to date, showed that TRYNAB is predominantly used in the most complex patients, those with the highest disease burden and the most challenging anatomy, and that PEDD-treated patients achieved better outcomes despite that higher baseline of clinical burden. Finally, the third question, does TRINAD make economic sense? That same HEOR study showed average reduced costs of approximately $7,700 per patient, driven by fewer inpatient stays, and fewer post-procedure complications. That matters more and more if hospitals and payers scrutinize the cost of every procedure and we're conducting additional sub-analyses to further quantify TRNF's favorable economic impact. Combined with the reimbursement developments I described earlier, including the reassignment of C8004 to a higher-paying APC and national pricing for the G-code for office-based labs, we believe the economic case for adopting Trinab continues to strengthen. Taken together, our clinical program is designed to close the evidence gaps between physician interest and routine clinical use of Trinib in the liver, proving it performs better, defining who benefits most, and demonstrating that it makes economic sense. Over the next several quarters, we expect to initiate our neuroendocrine and HCC studies, published PETR, and our retrospective HCC analyses. Over time, we believe this body of evidence can support the inclusion of PEDD in treatment guidelines. Moving to our third strategic focus, we continue to innovate and expand our indications and portfolio. Beyond the liver, we're applying the same disciplined stepwise approach. We start with pilot data and registries to establish feasibility and find the clinical signal. We then advance to formal prospective trials where the opportunity warrants it. In uterine artery embolization, our expanded retrospective study continues to enroll well, and we remain on track for our 50-patient target. We're now designing a prospective trial to formally evaluate Trinav's potential to streamline workflow, reduce procedure and fluoroscopy time, and improve outcomes. UAE is increasingly performed in the office-based lab setting, so we believe it could be one of the early beneficiaries of the G-code. Thyroid artery embolization, our PROTECT registry, continues to gain momentum across multiple centers. It has reached the enrollment needed for the interim analysis, and we remain on track to deliver the first multicenter U.S. data on TAE-PEDD in the first quarter of 2027. Janicular artery embolization, we've completed our pilot registry and now designing a formal clinical trial. We look forward to sharing updates as the program develops. Finally, on Nelotolimod, we remain on track to deliver consolidated perio data of our three dose escalation studies by year end. On our broader pancreatic strategy, we continue to evaluate significant changes in the pancreatal cancer treatment landscape. And we'll update you on our go-forward strategy once that analysis is complete. To close, we're actively putting the right pieces in place to support strong, sustainable growth and expansion looking forward. David will discuss our updated 2026 outlook shortly, which reflects the slower productivity ramp of our expanded sales team and a faster than anticipated shift towards super-selective Y90 administration in small distal vessels, which we could not fully address until the recent clearance of TriNav Advance. But as we prepare to close the year and enter 2027, the business is moving in the right direction, and we continue to believe we're well-positioned for stronger growth. We see several catalysts that we believe will support business acceleration, increasing productivity and the conversion of a growing funnel in our expansion territories, the launch of Trinav Advance, and expanded access to office-based labs through national pricing for the new G-code. In addition, we are exercising continued discipline in how we manage our costs. With that, I'll now turn over the call to David Patience, our CFO. Thank you, Mary, and good morning, everyone. Revenue for the third quarter was $12.9 million, up approximately 11% compared to $11.6 million in the prior year period, and up approximately 13% sequentially from $114 million inthe second quarter, driven by increasing demand for our innovative drug delivery technology, Trinav. Gross margin for the quarter was 86% compared to 84% in the prior year period. The improvement was driven by lower average unit costs of Trinab and our commitment to continuous manufacturing improvements. Research and development expenses were approximately $3.2 million compared to $5.7 million in the previous year. In the prior-year period, the decrease was primarily due the clinical trial expenses related to Nella Ptolema that did not recur in the current period. Sales and marketing expenses were approximately $10.7 million compared to $6.8 million in the prior year period, but down from $11.4 million in Q2 as we effectively managed costs. The year-over-year increase was driven by our investment in our expanded sales and marketing organization. General and administrative expenses were approximately $4.9 million compared to $6.1 million in the prior year period. The decrease was primarily due to lower professional service costs related to legal and audit-related expenses. Adjusted EBITDA loss for the quarter was approximately $5.4 million in a third quarter of 2025. The lower adjusted EBITD loss was driven by both higher TRYNAV product revenues along with lower operating expenses in the current period. We ended the quarter with approximately $41 million in cash, which we believe fully funds our strategic growth plan. Turning to guidance, we are updating our full-year 2026 revenue guidance to 46 million to 48 million, reflecting approximately 2% to 6% growth over full year 2025. Our updated range reflects two factors, the slower-than-expected productivity ramp of our expanded sales team and a faster-than anticipated shift towards super-selective Y90 administration in small distal vessels. That trend accelerated in the third quarter beyond what we had observed in the first half of the year, and we could not fully address it until the recent clearance of TriNav Advance. Despite these factors, as Mary mentioned, we are seeing continued expansion of our ordering account base and healthy revenue growth within our account, solidifying our confidence in a sequential step-up in revenue in the fourth quarter. Looking ahead to 2027, we have more growth drivers working for us than at any point in our history. First, and most important, a full year of productivity from our expanded commercial team. Second, with China's advance, we now have a complete liver portfolio that addresses super-selective cases and increasing adopted approach in liver embolization. Third, improved reimbursement for Y90 mapping procedures. Fourth, national pricing for the new G-code, which gives us comprehensive coverage across all sites of Clare, including office-based labs. Just as important, we believe we can deliver these revenue drivers on a more stable cost base, positioning us to lower our cash burn. We'll share more formal 2027 guidance on our fourth quarter call. Thank you all for the continued support. Dr. Marshall will join us for Q&A. With that, operator, we are ready to open the lines for questions. At this time, I would like to remind everyone, in order to ask a question, press star then the number one on your telephone keypad. We request to limit yourself to one question and one follow-up. We will pause for a moment to compile the Q&A question. Your first question comes from the line of Frank Takinen with Lake Street Capital Markets. Your line is open. Great. Thank you for taking the questions. Thank you for taking the questions. I was hoping to start with one on the geographies that are ramping slower than anticipated. First, maybe how many of your total sales geographies would fall into this category? And then any other color on maybe why those are ramped as slow as they are? And then as a third one, and sorry for so many at once, any unanticipated turnover across any of your sales force? Hi, Frank. Great questions. Let me answer your first one. So the geographies that are ramping more slowly are our expansion territories, and these are territories where we had previously no trinalis representation before, so they're just ramping more slowly because this is the first time these representatives are interacting with interventional radiologists, and they had no exposure to TRINAP. So their productivity is slower than our other representatives that are in the other territories. And there's about eight of them, and they're still growing month over month and growing sequentially. We just misjudged the ramp on those territories. Your third question in terms of what was the third one, ramping more slowly? I think I covered that. What was the first one? I know I missed it. Is there anything new? There's nothing new. No turnover. Virtually none since our new organization was put in place. Okay, that's great. Thank you for that. And then maybe just the other item in the quarter that you called out, the super selective Y90 administration. maybe speak to how large of a portion of the market does this pertain to? And now that you do have Advance, is that completely reopened to be able to commercialize into with Advance? Or is there still a portion that you may not be able access? Dr. Marshall, I'll hand it over to you just so I can give you kind of the components of, you know, the Y90 super-select approach was a much smaller component of the MIS for quite some time, and we believe we can fully address it with advance. And I'll have Dr. Marshall talk through it. So, Dr. Marshal? Yeah, so great question. I'll give you a little background on why we're seeing this shift. And this has certainly been something that's come to fruition fairly recently, but it's been developing over a couple of years. We've seen interventional radiologists aim for a higher dose of radiation in smaller tumors, and this is called ablative dosimetry. And when physicians can do that, we can achieve a very high rate of success, complete treatment of tumors. However, there is collateral damage. The normal liver around these tumors can be harmed. So for larger tumors, it hasn't been used as much. Physicians have started to do some selective treatment in larger tumors where they give multiple doses of very high dose of radiation in small areas. And until now, we haven't fully been able to address that technique. However, with the advent of ADVANCE, which has been in development for quite a while, we're very excited to see it come to market. We can add to these procedures by giving physicians more access to these tumors. We have launched a pilot study of advanced so far, and it has performed as we have expected. It's been very exciting to see. I've personally been able to do a couple of those cases, and we've been able to achieve multiple small-dose administrations very efficiently. So that is something that's very exciting to us, being able to address this part of the market that we previously haven't been ableto address in the past with all of the advantages of pressure-enabled delivery, including things like deeper delivery, more microspheres on target, improved efficiency, and improved angiography in those cases. And Frank, I'll follow up just to clarify the last question you had is super selective procedures that we can't address with ADVANCE, we can fully address all of them. So we're very pleased to have that now because that's a segment of the market that we we feel we could pursue aggressively now that we have that cleared got it that's very helpful thanks taking the questions your next question comes from the line of Bill Flavanek with Canaccord your line is open great thanks good morning I'd like to piggyback off Frank's question. What percentage of your sales was impacted by this super selective Y90 or what percentage of the market is that today? Where do you see that going? And then I wanted to ask on the guidance, you know, you're basically telling us fourth quarter is going to be anywhere from flat to up 2 million. What typically your fourth quarter up pretty significantly. So what are you seeing that gives you concern that it could be flat sequentially? Yeah, Bill, this is David. Thank you for the question. So, you know, as Mary had mentioned, of the MIS in the third quarter, a very small percentage was driven by the Y90 and the super selective portion of the market. The vast majority of the MIS was the expansion territory, which is roughly about a third of our field. And with that, you know we essentially you just uh you know overestimated what we could do in terms of the ramp but we're very excited to see what they here in the fourth quarter so that that that cohort has been ramping very strongly over the past two to three quarters with strong sequential growth that's giving us confidence in uh our guide we wanted to provide a a guide of where the field is today and what we think is achievable for the fourth corner And then on the why, you know, on the mix of business today in general that's, you know, at risk for the super selective, like as you think of the market in general? The reason we called out the super-selective use is now with trying to advance we can effectively address this portion of the markets which we are missing. This is the reason why we developed ADVANCE in the first place over the past couple of years. It's a smaller portion of just the care market, and then we're excited to access this. Yeah, maybe I'll have Dr. Marshall comment on that. Super Selective is really targeted towards smaller tumors, so Dr. Marshall, do you want to talk about where it's used and that segment of the market? Yes. So Super Selectives treatment has become very useful in patients with very small tumors. So if you can imagine that if you're being super selective in the liver, you're only selecting a very small part. Therefore, the tumors that are within that territory obviously have to fit in that. So we're talking about tumors that ARE2 centimeters and smaller, which represents a small portion of patients with hepatocellular carcinoma in general within the United States. What this does do is it allows us to reach those tumors. it also allows physicians to expand how they use pressure-enabled delivery. If they want to use that technique where they do multiple small treatments within a larger tumor, they can now do that as well. And both of those are very exciting because if we're adding pressure- enabled delivery advantages to those, we expect better results with what we know about pressure- enabled delivery in general. So it gives physicians confidence that in any case within the liver, they can access whatever they need to and utilize the techniques that they're comfortable with. Okay, thanks. And then for 2027, thanks for the caller. But, you know, your expectations are going to be pretty wide. You know, the jumping off point is changing pretty significantly. You know historically this was a, you call it a 25 to 30 percent plus growth company. You know, as we think about 27 and beyond, is that something that you can get back to, is that right? Or, you know, should we think of it, frame it differently, you know, if we look into 27 and beyond? So, this is David. You know we're going to give more specifics about 2027 on our fourth quarter guide. At a high level, we're very optimistic about the improving productivity of our expanded sales team and seeing a full year from that team. You know, we're confident in accelerating very meaningful double-digit growth into next year, but we just want to be prudent and give guidance for protocol. Thank you. Your next question comes from the line of Justin Walsh with Jones Trading. Your line is open. Hi, thanks for taking the question. I was wondering if you can provide some additional commentary on competitive dynamics. It would be great to hear what you've heard from interventional radiologists related to the comparative benefits of TriNav versus alternative catheters, and maybe what messaging has resonated, particularly in the new targeted geographies. It's a great question, Justin. You know, what's most interesting about our competitors is our biggest competitor, and truly our really only competitor is the standard microcatheter. So this is an old decade, you know, a commodity-type product. And so our goal for communicating with physicians is talking through the benefits of why Trinav can be a better delivery for their patients where we could deliver more drug to the tumor, protect off-target delivery, and provide a better overall outcome experience for the patients. Probably our biggest challenge that we encounter in terms of selling to our physicians is, you know, we're a premium-priced product. Address the economics with them, and once we do that, we have success in terms OF adoption at the hospital. Thanks for taking the question. Your next question comes from the line of Charles Wallace with HSC Winwright. Your line is open. Hi. This is Charles. I'm for RK. Thanks for taking my question. I guess first for me, I was wondering if you could provide how many reps that you recently hired at the full target of productivity, if there's been any attrition in that team? on? So yeah, we haven't seen any real attrition. And then with that, we doubled the sales organization in late Q1 and early to mid Q2. So majority of the field has been here for just four to six months. We're excited to see the progress of the expanded field, as well as the durable growth within our historical territories as well. So where we are is, I think we're just excited to see what the positive momentum that we have and we're on the right track. And then maybe one question kind of on the guidance. So, you know, you've mentioned that the Try and Have Advance is in its limited launch right now. So in the fourth quarter, does the guidance include any revenues from Advance? And then, maybe another question on Advance, when does the broad launch start? What's your expectation for that? Thank you. Yeah, for the fourth quarter guide, as Dr. Marshall mentioned, we're really seeing the product test and see through what we are able to achieve with the product. And so with that, we do not have any numbers in the fourth-quarter guide. We're looking to bring advance to market as quickly as possible, but we want to make sure we get it right. So we should be able to provide more guidance on it as it relates to next year on our fourth- quarter call. Okay, thanks for taking my questions. I will now turn the call back over to Mary Zella for closing remarks. Thank you all for your questions, I appreciate it. Ladies and gentlemen, that concludes today's call. Thank you for joining. You may now disconnect.