管理層發言
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 T. Szela, president and chief executive officer; David Patience, chief financial officer; and Dr. Richard Marshak, medical director. Mary will provide an overview of our first quarter results and our strategy for the balance of the year. David will then walk through the financial results in detail. Dr. Marshak will join Mary and David for the Q&A portion of the call. Earlier today, TriSalus released its financial results for the quarter ended 03/31/2026. A copy of the press release is available on the TriSalus Investor Relations website. Today, TriSalus also announced the public 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 2000. 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 only as of today's live broadcast 05/12/2026. And with that, I will turn the call over to Mary.
Thank you, Jeremy, and good afternoon, everyone, and thank you for joining us. I will 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 multiyear 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. And 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 $7.7 thousand 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 will 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. And it is 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 and in 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; and a realigned, significantly larger field footprint that scales for future growth. Anchoring the expansion is Chris Sowd, 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 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 are 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, the costs of territory realignment, representative onboarding, representative time out of the field for training, and the rebuilding of account relationships. 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 our 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 to $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 extends PEDD capability to small distal vessels via microcatheter. FDA review of TriNav Advance is now running five months past the 30-day MDUFA review goal. We have 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 advanced 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 using the microcatheter of their choice. Today, physicians who employ a super-selective approach prefer to track to the site of delivery with their existing microcatheter. TriNav Advance meets them where they are already in practice. Revising guidance is an adjustment that the TriSalus team does not 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 will 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 16.2 thousand 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 2024. The cohort comprises 515 TACE patients and 88 TARE 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 was compelling. Despite higher baseline disease burden, the data demonstrates that PEDD is not simply a device, but a highly differentiated therapeutic delivery capable of improving liver embolization outcomes, reducing health care utilization, and expanding treatment possibilities across multiple indications. PEDD-treated patients achieved statistically 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%, and roughly a nine-fold 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: PEDD 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 three, the more a center uses PEDD, the better the outcomes. At top 5% adoption facilities, the lymphopenia gap widens and liver metastatic outcomes improve sharply across both the TACE and TARE practice patterns. In secondary liver metastases, patients at high adopter centers had fatigue cut by more than half, 19.2% versus 39.7%, and lymphopenia was nearly eliminated, 0% versus 8.2%. Bottom line: the more a center uses PEDD across either TACE or TARE, the better the outcomes get. Call adoption and institutional experience compound the benefit. Number four, downstream cost avoidance: per patient cost avoidance of approximately $7.7 thousand across the full 603-patient PEDD cohort—roughly $3.1 thousand from fewer inpatient stays and $4.6 thousand from fewer post-procedure complications. Cost avoidance holds across both TACE and TARE 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 TACE and TARE cases. This large landmark publication validates what we have 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 is 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 ten 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 is 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 are also preparing to publish results from two completed investigator-initiated trials: the TETHER study at Massachusetts General Hospital and TRI-FI 90 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 TARE in HCCs. This will provide cost-efficient evidence on outcomes and target populations and will provide the basis for the clinical trial design of our larger prospective clinical trials we plan to initiate in 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 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 fibroid 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 the study to 50 patients, and we are 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 therapy. 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 multicenter 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 where 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 are methodically building both the clinical evidence base and the commercial infrastructure to address all of them. A brief update on our nalotolimod program: we remain on track to deliver our consolidated PERIO-1 readout in 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 dataset 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, 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 nalotolimod data, we are 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 nalotolimod and our broader pancreatic program is unchanged. Consistent with the strategy we previously communicated, we intend to advance these programs through a partnership structure 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 are building toward. Entering the remainder of 2026, we have a substantially expanded commercial organization in place poised to accelerate multiyear growth, the most significant real-world evidence dataset in our history published in a peer-reviewed journal confirming the statistically 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 nalotolimod data update in the second half; delivering our full year 2026 revenue of $54 million to $57 million; and lastly, subject to FDA clearance, launching TriNav Advance in the second half. We are 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 are creating for both patients and shareholders. With that, I will 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 31, 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 cost on TriNav and our continuous manufacturing improvement. Research and development expenses were approximately $3.2 million compared to $3.0 million in the prior year period. The increase was driven by non-cash stock-based compensation expense. The current period includes approximately $500 thousand 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 thousand 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 2025. As of 03/31/2026, 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. And with that, operator, we will open the line for questions.
分析師問答
Thank you. And wait for your name to be announced. To withdraw your question, please press 1-1 again. One moment for questions. And our first question comes from Frank Takkinen with Lake Street Capital Markets. You may proceed.
Was hoping to start with one on the quarter and then kind of forward-looking from there. On the quarter, maybe specifically, the 40% called out that were disrupted in the sales force, can you help quantify just maybe how much disruption that caused? And then maybe more importantly, as you are 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?
So hi, Frank. Let me talk first about the 60%. Sixty percent of our sales territories were not disrupted, and we saw them perform as expected. Think of that as a control group. So we are very comfortable that there has been really no fundamental change in demand or in the underlying growth of the business. Now in the remaining 40%, we changed two dynamics: rep-to-manager and rep-to-physician. It was largely a result of our growth. It got to the point where the territories had grown so substantially that it was inadequate for those reps to cover them. So that caused some disruption in sales because we restructured those territories. We also had some new reps coming in, which meant time out of the field for training. So that was the driver of Q1 performance. We are largely in place today, and we are really happy with what we are seeing. I have been through many different sales expansions in the past. You always have a short-term hit when you make these transitions. But if you do it in the right way, which I believe we have—with the right talent and the right territory footprint—we will start to see that ramp continuously throughout the rest of the year.
Okay, that is helpful. And then maybe as 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 be hired to hit that doubling? And if that is the case, maybe when will that be expected to be complete?
Thank you for asking that question. One of the things that occurred during Q1, largely due to the capital raise, was that the level of talent we were attracting to the company was unprecedented for us. That drove us to make the decision to slightly expand even further than what we originally envisioned. So yes, we are at roughly a doubling of the organization, and we think that was the right decision at this point. We have enormous growth potential across a $2.5 billion market spanning liver and the new applications. We now have the right footprint of organization and 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 is helpful. I will hop back in queue.
Thank you.
Our next question comes from William Plovanic 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 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 VP, regional managers, territory managers that are quota-carrying, and then, obviously, the clinical. Kind of what were those numbers generally pre- and post this transition?
Hi, Bill. We are not providing specific headcount numbers, but let me give it to you qualitatively. Over the last three years, we had been adding marginally a couple 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 to more than double. We also changed the rep-to-manager ratio and added another executive-level management tier, which we think is important because, in light of the data that we are producing, we now have the opportunity to reach out to hospital systems and payers. We think this will be an important catalyst as we move forward because the data is so strong. So we now have an organization sized for the full 400 accounts that we want to pursue across liver and the new applications.
And it sounds like this started in early March and you feel like you completed this by May. What is the typical ramp time for a rep? And then how should we think about revenue cadence for the year? Is Q2 up year-over-year? My numbers suggest it is probably going to be down closer to about $10.5 million, and then the ramp through the rest of the year because I think you mentioned the cadence would be pretty linear and consistent.
You are exactly right. We typically see a six- to nine-month ramp for our reps. The talent of these reps has been outstanding; all the reps are largely in place. So we anticipate for the remainder of the year month-over-month continual growth. We have been reasonable in our assumptions, and what we are seeing is some of these reps come out of the gate strongly. I will hand it over to David to talk about the ramp and cadence.
Yeah, Bill. To provide some context on the second half of the year: the expansion and the fact that the doubled size is largely in place includes both reps that carry quotas and specialists that are in the territory supporting those quotas as well. As that productivity ramps, we are also bringing online additional capacity, and that is what is going to drive the step-up from prior periods in the second half of the year. We feel that the second-half ramp is structurally built, and we are excited to see those reps start contributing in a meaningful way.
But, David, how should we think about Q2? I mean, I think with the reset, we just want to make sure that we are thinking the same way you are. Any comments on the $10.5 million estimate or the number I am thinking of?
For the second quarter, we are thinking that would be a marginal sequential gain quarter-over-quarter as these reps are coming out of training. The meaningful progress will come as they reach productivity in Q3 and Q4.
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 am 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. We are very proud of this data. Right before this call, we spoke with one of the physicians whom I would characterize as a pioneer in interventional radiology and he was incredibly enthusiastic. What we are starting to see in this specialty is a growing valuation of real-world data—how this technology works not only in expert academic centers, but across community centers as well. This dataset, together with our prospective clinical data, strengthens the evidence that this delivery platform is significant and has both clinical benefit and cost-effectiveness. By building this interconnected database, we believe we can begin to create a dataset that supports PEDD becoming standard of care and inclusion in relevant guidelines. Dr. Marshak, would you like to comment as a practicing interventional radiologist?
I do. I think the most interesting part about this data is that it is real-world data. This comes from physicians actively practicing—as opposed to a prospective study designed with tight parameters. This is what is happening across the U.S., and it validates many of the things we have been saying about TriNav. It is a different way of thinking about data in interventional radiology. Large drug companies often use HEOR data to understand economic value; we are shining a light on some of the clinical and economic benefits these procedures bring to patients.
I would add one aspect that I thought was really profound and which has resonated with oncologists who have reviewed the data: the lack of lymphopenia. That finding resonates strongly. One of the questions in these treatments has been whether embolization can be used in combination with immunotherapy regimens. If embolization results in elevated liver enzymes or lymphopenia, it can disrupt a patient's systemic therapy. This data provides validation that PEDD can be impactful without disrupting subsequent treatment, and this is the first time we've had this kind of real-world evidence. We think it could impact not only the interventional radiology community but also the oncology community.
Great. Thanks for taking the question.
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. Thank you again for the support of the company.
Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.