TLSI

Good afternoon, and welcome to the TriSalus Life Sciences First Quarter 2026 Earnings Conference Call. All participants are currently in a listen-only mode. Following management's prepared remarks, we will hold a question and answer session. 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.

Thank you, operator, and thank you all for joining us today. With me from TriSalus Life Sciences are Mary Szela, President and Chief Executive Officer, David Patience, Chief Financial Officer, and Dr. Richard Marshall, Medical Director. Mary will provide an overview of our first quarter results and our strategy for the balance of the year. David will walk through the financial results in detail. Dr. Marshall will join Mary and David for the Q&A portion of the call. Earlier today, TriSalus released its financial results for the quarter ended March 31st, 2026. A copy of the press release is available on the TriSalus Investor Relations website. Today, TriSalus also announced the publication of a landmark real-world evidence study evaluating the clinical and economic impact of our Pressure-Enabled Drug Delivery, or PEDD technology. Mary will discuss that study in detail.

Before we begin, I would like to remind you that during today's call, management will make forward-looking statements within the meaning of the federal securities laws. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements other than statements of historical fact, including, without limitation, statements regarding our sales and operating trends, business and hiring prospects, financial and revenue expectations, and future product development and approvals are forward-looking. They are based on current estimates and assumptions and involve material risks and uncertainties, including the impact of macroeconomic conditions and global events that could cause actual results to differ materially from those anticipated. 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 Risk Factors section of our Forms 10-Q and 10-K on file with the SEC and available on EDGAR, as well as our other periodic filings. TriSalus disclaims any obligation, except as required by law, to update or revise any forward-looking statement, whether due to new information, future events, or otherwise. This call contains time-sensitive information and is accurate only as of today's live broadcast, May 12, 2026. With that, I'll turn the call over to Mary.

Thank you, Jeremy, and good afternoon, everyone, and thank you for joining us. I'll cover four topics today. First, our first quarter results. Second, the deliberate realignment and significant expansion of our commercial organization, creating a foundation to capture the multi-year growth that a cadence of new clinical and health economic evidence will unlock over the next 18 months. Third, our updated 2026 guidance and the outlook for the balance of the year. Fourth, in my view, the most important news of the quarter, the publication of landmark real-world evidence on PEDD, the largest study of its kind ever conducted, demonstrating fewer complications, fewer hospitalizations, and roughly $7,700 per patient in cost avoidance. This is meaningful news for TriSalus and, more importantly, for the patients we serve. David will then provide a detailed financial review, and we'll take your questions.

As we previewed on our 2025 year-end call, our 2026 plan called for a disciplined investment in commercial infrastructure designed to deepen physician engagement, extend our footprint to cover new applications, and lay the foundation for future growth. It's why we raised capital this quarter. After several years of significant growth, our territories were expanding beyond what individual representatives and our sales leaders could cover effectively, and the gap was widening as the new applications began to emerge. Continuing to operate at the prior scale was simply not a path to capturing the full opportunity ahead of us in the liver embolization market or the new applications we are entering. The investment had three core dimensions: new commercial leadership, a meaningful expanded talent base across sales leadership, field management, and clinical specialist roles, a realigned, significantly larger field footprint that scales for future growth.

Anchoring the expansion is Chris Staudt, who recently joined us as Senior Vice President of Sales and Commercial Operations. Chris brings more than 20 years of commercial leadership in diagnostics and in life sciences, with senior roles at Roche, Ventana, Luminex, and most recently, Accelerate Diagnostics, where he led U.S. commercial. He has a proven track record of building and scaling high-performing field organizations and securing strategic partnerships with leading health systems, an important initiative we want to pursue. Chris is precisely the Operator we need to lead our commercial organization through this next phase of growth, and we're fortunate to have him on our team. As of May, the new significantly expanded sales organization is largely in place.

As with any expansion of this scale, Q1 revenue reflects the transition of costs of territory realignment, representative onboarding, representative time out of the field for training, and the rebuilding of account relationships. In roughly 60% of our territories, where the rep-to-physician relationship remained intact, sales performed in line with expectations. In the remaining 40%, we deliberately modified two critical relationships at the same time: rep to physician and rep to manager. Both are primary drivers of execution and unit volume. Modifying them simultaneously was the right strategic choice. We expect sales productivity to improve steadily throughout the balance of the year, complemented by growing contributions from new clinical data, new account capture, and penetration into new applications. Q1 performance was not a function of softer demand or any change in the underlying fundamentals of our business.

It reflects the deliberate cost of a build-out phase, investing now in the commercial engine required to scale this organization for our next phase of growth. We are revising our full year 2026 revenue guidance to a range of $54 million-57 million. The driver of this revision includes both the lower Q1 revenues from the Commercial Expansion and the delayed FDA clearance timing for TriNav Advance, our next-generation device which extends PEDD capability to small distal vessels via microcatheter. FDA review of TriNav Advance is now running approximately five months past the 30-day MDUFA review goal. We've been in active dialogue with the FDA, and while we still expect clearance in the second half of the year, we are taking a prudent approach to forecasting the launch given the inherent unpredictability of clearance timing and the appropriate market evaluation period that follows.

This timing shift removes our Advance revenue expectations from the second half of the year due to the clearance delay. We remain enthusiastic about the launch. TriNav Advance creates an incremental market opportunity by enabling interventional radiologists to access the benefits of PEDD while using the microcatheter of their choice. Today, physicians who employ our super selective approach prefer to track to the site of delivery with their existing microcatheter. TriNav Advance meets them where they're already in practice. Revising guidance is an adjustment the TriSalus team nor I take lightly. We remain fully committed to our investors and to executing against the goals we set. We believe taking a measured posture on TriNav Advance is the right one. Once Advance is in our hands, we'll have a complete portfolio supporting the full range of liver embolization procedures.

I want to spend a moment on the development of the quarter that matters most for TriSalus and more importantly, the patients we serve. Today, we published the largest real-world evidence study of PEDD ever conducted. It includes 603 PEDD patients matched against more than 16,210 non-PEDD patients drawn from a 300 million patient population-based claims database covering 96% of U.S. payers, with data spanning January 2020 through March of 2024. The cohort comprises 515 TARE patients and 88 TACE patients, making it the largest TARE PEDD dataset ever published and the most comprehensive PEDD dataset across both embolization modalities. The analysis used a rigorous two-stage matching design, Coarsened Exact Matching paired with propensity score matching applied to both the overall cohort and to each modality subgroup. The headline result is compelling.

Despite higher baseline disease burden, the data is demonstrating that PEDD is simply not a device, but a highly differentiated Therapeutic Delivery Platform capable of improving liver embolization outcomes, reducing healthcare utilization, and expanding treatment possibilities across multiple indications. PEDD-treated patients achieved statistically significant better outcomes across every measure. Four takeaways stood out. Number one, less fatigue and preserved immune function across the full cohort. Significantly less post-procedure fatigue across the full cohort, 20.9% versus 26.4%. Roughly ninefold reduction in lymphopenia at high adopter centers, 0.6% versus 5.2%. Preserving lymphocyte counts is clinically critical since lymphopenia is a known barrier to downstream immunotherapy. Bottom line, PED patients leave the procedure with their immune systems more intact and remain eligible for follow-on immunotherapy treatment. Number two, lower 30-day readmissions in the TACE subgroup, driven by significantly improved tumor targeting.

PEDD delivered approximately 48% more doxorubicin per procedure. PEDD procedures had 30-day inpatient admissions cut by more than half, 8% with PEDD versus 20.5% without. Bottom line, direct evidence of improved tumor targeting with less off-target toxicity. Number threethe more a center uses PEDD, the better the outcomes. At top 5% adoption facilities, the lymphopenia gap widens further and further, and liver metastatic outcomes improve sharply across both the TARE and TACE practice patterns. In secondary liver metastases, patients at high adopter centers, fatigue was cut by more than half, 19.2% versus 39.7%. Lymphopenia was nearly eliminated, 0% versus 8.2%. Bottom line, the more a center uses PEDD across either care or case, the better the outcomes get. Early adoption and institutional experience compound the benefit. Number four, downstream cost avoidance.

Per patient cost avoidance of approximately $7,700 across the full 603 patient PEDD cohort. Roughly $3,100 from fewer inpatient stays and $4,600 from fewer post-procedure complications. Cost avoidance holds across both TARE and TACE and is not isolated to one modality. Higher and more durable response rates may further reduce total procedures per patient, compounding the economic benefit over time. Bottom line, PEDD effectively reduced downstream costs in both TARE and TACE cases. This large landmark publication validates what we've been saying for years about the clinical rationale for PEDD, and it does so in patients representative of everyday clinical practice. For our physician customers, it reinforces that the investment in PEDD competency pays compounding dividends. For our commercial team, it's a peer-reviewed evidence at scale that accelerates institutional adoption. Beyond this publication, we continue to generate new Clinical Evidence on the patient impact of PEDD.

We now have 10 active studies underway across 24 clinical sites, generating data on more than 400 TriNav-treated patients. Two new prospective investigator-initiated trials are set to begin enrollment this quarter. A study called PRESSURE at Stanford is a randomized study of TriNav and TARE for liver metastases comparing tumor-absorbed dose, response rate, and disease control to the current standard delivery. PREDICT at MD Anderson, a prospective study evaluating PEDD impact in hypovascular tumors. Both are designed to generate exactly the kind of prospective head-to-head data that drives clinical adoption at top academic centers. We're also preparing to publish results from two completed investigator-initiated trials, the PETER study at Massachusetts General Hospital and TRIFY90 at MD Anderson. Both have completed data analyses and are targeting publication submission this quarter. We believe these readouts will be a meaningful catalyst for second-half commercial momentum.

Lastly, we initiated two large retrospective studies during the quarter examining TriNav-delivered care in HCCs. This will provide cost-efficient evidence on outcomes and target populations and will provide the basis of the clinical trial design of our larger prospective clinical trials we plan to initiate in the second half of 2026. Beyond liver, we continue to build meaningful momentum across our new applications, uterine artery embolization, thyroid artery embolization, and genicular artery embolization, each a significant and independent growth factor. At SIR in 2026, Dr. Francis King of Rutgers Robert Wood Johnson Medical School presented a retrospective analysis of PEDD in uterine artery embolization. The headline is the kind of number you rarely see in interventional medicine. Median dominant thyroid volume reduction of 97.5% versus a historical literature comparator of approximately 50%.

This is a step change in clinical effect achieved with less embolic material and shorter procedure time, exactly what you would expect from a more targeted delivery mechanism. The study also reported 100% technical success with no device-related complications and sustained reductions in pain and heavy menstrual bleeding at both one and six-month follow-up. In Q1, we approved expanding this study to 50 patients and we're actively designing a prospective trial to further evaluate TriNav's potential to streamline workflow, reduce procedure and fluoroscopy time, and improve outcomes in uterine artery embolization.

Our PROTECT registry continues to roll across multiple centers, evaluating PEDD for patients with thyroid nodules or goiters who are not candidates for conventional therapies. Preliminary results published in the Journal of the Endocrine Society demonstrate 100% technical and clinical success, a 73% reduction in thyroid size, and normalization of thyroid function in 71% of participants with no neurovascular complications.

These are remarkable results for a minimally invasive outpatient procedure. In February, Dr. Juan Camacho and his colleagues published a review of thyroid artery embolization in Seminars in Interventional Radiology, highlighting PEDD's unique ability to enhance distal distribution and reduce the need for carotid circulation catheterization. We now have enrolled more than 50% at our 11 sites who are actively recruiting patients. PROTECT is on track to deliver the first multi-center U.S. data on thyroid artery embolization and to position PEDD-TAE as the leading approach for this procedure. We just concluded a pilot registry and now are preparing to launch a formal clinical trial evaluating genicular artery embolization for knee osteoarthritis, a condition affecting more than 30 million adults in the United States. GAE represents a novel, minimally invasive approach to pain management and mobility preservation, with the potential to delay or avoid knee arthroplasty in appropriate patients.

This is an emerging field, and we believe our PEDD platform is uniquely positioned to drive the clinical rigor needed to establish it as standard of care. Collectively, these indications represent a U.S. addressable market of approximately $2.5 billion, and we're methodically building both the Clinical Evidence base and the commercial infrastructure to address all of them. A brief update on our nelitolimod program. We remain on track to deliver our consolidated PERIO phase I readout in the early second half of 2026. As a reminder, that readout will combine data from three completed dose escalation studies, along with emerging data from an ongoing investigator-initiated study, and deliver them as a single complete data set rather than a series of sequential partial releases. This approach reflects our commitment to a rigorous, internally validated package, one we believe will most clearly demonstrate the program's potential.

The timing is not driven by any safety signal or by any efficacy concern or by any change in our strategic priorities. In parallel, we continue to advance our broader pancreatic strategy. Pancreatic cancer remains one of the most significant unmet needs in oncology, and we believe our novel pancreatic PEDD device is uniquely suited to overcome the delivery barriers that have long limited therapies in this disease. As we prepare to share the nelitolimod data, we're also building the case for PEDD as an adjunct to current and next generation pancreatic regimens. We expect to have more to share as the year progresses. Our commitment to both nelitolimod and our broader pancreatic program is unchanged.

Consistent with the strategy we previously communicated, we intend to advance these programs through a partnership structure, one designed to preserve their long-term value while maintaining the capital discipline required to fund our near-term commercial and clinical priorities. Before I turn the call over to David, let me summarize where we stand and what we're building towards. Entering the remainder of 2026, we have a substantially expanded commercial organization in place poised to accelerate multi-year growth. The most significant real-world evidence data set in our history, published in a peer-reviewed journal confirming the statistical significant clinical and economic value of PEDD at scale, and a pipeline of new applications and clinical readouts that build throughout the year.

Our near-term milestones include generating differentiated clinical data across UAE, TAE, and GAE, releasing a nelitolimod data update in the second half, delivering our full year 2026 revenue of $54 million-57 million, and lastly, subject to FDA clearance, launching TriNav Advance in the second half. We're executing against all of these priorities from a position of financial strength with the growth capital we raised in Q1 fully supporting our strategic roadmap. I remain deeply confident in our team, our platform, and the long-term value we're creating for both patients and shareholders. With that, I'll turn the call over to David.

Thank you, Mary, and good afternoon, everyone. Let me walk through the results for the first quarter ended March 31st, 2026. Revenue for the first quarter was $8.9 million compared to $9.2 million in the prior-year period. The lower revenues were due to the transition related to the expanded commercial organization. Gross margin for the quarter was 86% compared with 84% in the prior-year period. The improvement was driven by lower average unit costs on TriNav and our continuous manufacturing improvement. Research and development expenses were approximately $3.2 million compared to $3 million in the prior-year period. The increase was driven by non-cash stock-based compensation expense. The current period includes approximately $500,000 of non-cash stock-based compensation expense.

Sales and marketing expenses were approximately $7.4 million compared to $6.7 million in the prior year period. The increase reflects our deliberate investment in expanding our commercial footprint, including headcount, onboarding, expanded training, and territory development costs associated with the sales force expansion. The current period includes approximately $500,000 non-cash stock-based compensation expense. General and administrative expenses were approximately $5.4 million compared with $5.2 million in the prior year period. The increase was driven by higher non-cash stock-based compensation expense. The current period includes approximately $1.3 million of such expense. Consistent with prior years, we expect first quarter G&A expenses to be higher than subsequent quarters as many annual public company expenses materialize in the first quarter. Net operating loss for the quarter was $8.4 million compared to $7.3 million in the prior year period.

The increase reflects two factors: lower revenue from the Commercial Expansion and a deliberate increase in sales and marketing investment associated with our Commercial Expansion. Adjusted EBITDA loss for the quarter was approximately $5.8 million, compared to $5.5 million in the first quarter of 2025. As of March 31st, 2026, cash and cash equivalents totaled $56.6 million. In closing, the fundamentals of the business are strong. Gross margins remain durable in the mid-80s, and our cash position fully funds our strategic growth plan. The investment we made in Q1 in our commercial organization and as we continue to make in PEDD Clinical Evidence are foundational and will compound. They allow TriSalus to scale successfully and fully execute for the next phase of growth. We look forward to demonstrating that progress as the year unfolds. Thank you all for your continued support.

With that, operator, we will open the line for questions.

Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. One moment for questions. Our first question comes from Frank Takkinen with Lake Street Capital Markets. You may proceed.

Great. Thank you for taking my questions. I was hoping to start with one on the quarter and then kind of forward-looking from there. On the quarter, maybe specific to the 40% called out that were disrupted in the sales force, can you help quantify just maybe how much disruption that caused? Maybe more importantly, as you're looking at the business now and as you were exiting the quarter and into second quarter now, what can you tell us to give us a little bit of confidence really in the recovering trajectory of the business to achieve the guidance range for the year?

Hi, Frank Takkinen. How are you? Let me talk first about the 60%. 60% of our sales or territories were not disrupted, and we saw them perform as expected. Think of that as a control group. We are very comfortable that there's been really no fundamental change in demand, no fundamental change in terms of the adoption and continued growth in the business. Now, in the remaining 40%, we changed two dynamics. We changed rep to, you know, manager and rep to physician. It was largely a result of just our growth. You know, it got to the point where the territories had grown so substantially that it was inadequate for those reps to cover them. That caused some disruption in sales because we disrupted those territories.

We also had some new reps coming in, which was time out of the field. That was the driver of Q1 performance. We're largely in place today, and we're really happy with what we're seeing. You know, I've been through many different sales expansions in the past. You always have a short-term hit when you make these transitions. If you do it in the right way, which I think we have the right talent and the right territory footprint now, we'll start to see that ramp continuously throughout the rest of the year.

Okay. That's helpful. Maybe as a, my follow-up, I think last call you were talking about effectively doubling the sales organization. Maybe an update related to that. Have you achieved that level of hiring? Is there still a portion that needs to hire to hit that doubling? If that's the case, maybe when will that, is that expected to be complete?

Yeah. Thank you for asking that question. You know, one of the things that occurred during Q1, this was largely due to the capital we raised, just the level of talent of who we were attracting to the company was really unprecedented for us. That drove us to make the decision to slightly expand even further than what we originally envisioned. You know, we are, you know, a little bit above that, you know, doubling of the organization, we think that was the right decision to make at this point. We have just enormous growth potential. You know, $2.5 billion market, cross liver and all the new applications.

We now have the right footprint of organization, the right combination of management, clinical specialists, and reps that really allow us to scale this company far beyond where we are today.

Okay, that's helpful. I'll hop back in queue. Thank you.

Thank you. Our next question comes from William Pavlik with Canaccord Genuity. You may proceed.

Hey, great. Thanks. Good evening. Thanks for taking our questions. Just like to start out first, I was wondering if you could level set us with, you know, what was the composition and size of the commercial organization prior to the expansion and kind of numbers? Where does that sit now as we look at, you know, managers like, you know, VP, regional managers, territory managers that are quota carrying, and then obviously the clinical. Kinda what were those kind of numbers generally, pre and post this transition?

Hi, Bill. How are you? We're not giving specific numbers, but let me give it to you in a qualitative standpoint. Over the last three years, we've been adding kind of very marginally two reps at a time. We had really started to stretch the manager to rep relationship where it got above double digits, which was too much. In this new reorganization, we expanded the number of territories, you know, more than double. We also really changed the rep to manager level. We added another executive level of management, which we think is really important because in light of the data that we're producing, we now have the opportunity for them to reach out to hospital systems and payers.

We think this is gonna be an important catalyst for us as we move forward because the data is so strong. We now have an organization that's sized for the full 400 accounts that we wanna pursue both in the liver and the new applications.

It sounds like this started in early March, and you feel like you've completed this by May. What is the typical ramp time for a rep? How should we think about revenue cadence for the year? You know, is Q2 up year-over-year? Kinda in my numbers, it's probably gonna be down closer to about $10.5 million. You know, the ramp through the rest of the year, 'cause I think you mentioned the cadence would be pretty linear and consistent at least. I mean, those are my words, not yours, that was my takeaway. Thanks.

Yep. No, it, you're exactly right. We, we typically see with our reps, now the talent of these reps are just outstanding. We see a six to nine-month ramp. All the reps are largely in place. We anticipate for the remainder of the year just to see month-over-month continual growth. I think we were, you know, we've been really reasonable in our assumptions. However, what we're seeing is some of these reps come out of the gate pretty strongly. I'll hand it over to David to talk about the ramp, but we feel confident about the rest of the year.

The caliber and the quality of these reps that we were attracting, and just to give you a little bit of color on that, we never were really able to get people away from the big companies who have been there 15, 18 years. That's the type of reps that we were getting here that were coming to us. Just deep, you know, relationships with the interventional radiologists, a lot of interventional radiology knowledge, really excited about the company and where we were going. We think that's gonna bode well in terms of performance throughout the year.

Yeah, Bill, this is David. To provide some context on the second half of the year, you know, we're thinking about exactly the expansion and the effect of the doubled size is largely in place, and that includes both reps that carry quotas and specialists that are also in the territory supporting those quotas as well. As that productivity is ramping, you know, we also are bringing online additional capacity, and that's what's gonna drive the step-up, you know, from prior periods in the second half of the year. We're very excited about the capacity that we've built, so we feel that the second half ramp is structurally built, and we're very excited to see those reps start contributing in a meaningful way.

David, how should we think about Q2? I mean, I think with the reset, we just wanna make sure that we're thinking the same way you are. You know, any comments on the ten and a half million-ish estimate or number I'm thinking of?

Yeah, Bill, for the second quarter, we are thinking that would be for, you know, marginal sequential gain quarter-over-quarter as these reps are coming out of training. I think where you are is a fair point, we would see that meaningful progress as they reach productivity, you know, in Q3 and Q4.

Thank you. As a reminder, to ask a question, please press star one one on your telephone. Our next question comes from Justin Walsh with JonesTrading. You may proceed.

Hi. Thanks for taking the question. I would love to hear your thoughts on where you see the new PEDD data having the most direct impact. I'm curious about the balance of clinical versus economic benefit and how that will resonate with physicians and institutions to help drive additional adoption.

Really good question. I think we're really proud of this data. In fact, right before this call, we just got off a call with one of the physicians who I would characterize as really the father of interventional radiology. I think what we're starting to see in this specialty is really begin to value the real world data. How is this technology, you work, not only in the, you know, expert academic centers, but how does it work across all the community centers? The way he characterized this data, he was just incredibly enthusiastic, and I'll have Dr. Marshall talk about it as well. It just validates a lot of our prospective clinical data.

Together, this data set with all the other studies that we've conducted, it just strengthens that this delivery platform is really significant, and it has both clinical, you know, both clinical side effect and cost-effective data. We believe by building this database that is so interrelated in this way, that we can begin to create a data set that, you know, really creates this as standard of care and be inclusion in the NCCN guidelines. Dr. Marshall, you wanna comment on it? Because I think as a practicing interventional radiologist, I think you'll have some thoughts on this data as well.

I do. I think the most interesting part about this data is that it's real world data. This is from physicians who have been practicing. This is not a prospective study that's designed with tight parameters to ensure good data. This is actually what's happening in the U.S. It does validate a lot of the things that we've been saying, the things that we know about TriNav. It's a different way of thinking about looking at data in interventional radiology. This is something that we see large drug companies do, is use HEOR data to help understand the economic value of their products. We're shining a light on some of the things about interventional radiology that have been ignored, helping physicians understand the value that their procedures bring to patient care.

I thought I'd comment on one aspect that I thought was really profound and that we've heard from some of the other interventional radiologists who have looked at the data. One of the things in terms of having no effect on lymphopenia, that to oncologists has been resonates really strongly. One of the things that's critical in these treatments, there's always been a question about whether embolization can be used in combination with some of the other immunotherapy regimens. You know, if you have elevation in liver enzymes, if you have lymphopenia, often that can disrupt a patient's treatment. When they saw this data, this is just giving them validation that this type of approach can be really impactful for patients, and they don't have to disrupt the treatment. This is the first time we've had this type of data before.

We think this could not only impact the interventional radiology community, we think it could have real impact in the oncology community as well.

Great. Thanks for taking the question.

Thank you. I would now like to turn the call back over to Mary for any closing remarks.

Well, thank you for your time today. I really appreciate it, and thank you again for the support of the company.

Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.