NASDAQ:TLSI TriSalus Life Sciences Q1 2025 Earnings Report $4.90 -0.17 (-3.35%) Closing price 05/14/2025 04:00 PM EasternExtended Trading$5.14 +0.24 (+4.88%) As of 08:57 AM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast TriSalus Life Sciences EPS ResultsActual EPSN/AConsensus EPS -$0.20Beat/MissN/AOne Year Ago EPS-$0.60TriSalus Life Sciences Revenue ResultsActual RevenueN/AExpected Revenue$9.04 millionBeat/MissN/AYoY Revenue GrowthN/ATriSalus Life Sciences Announcement DetailsQuarterQ1 2025Date5/15/2025TimeBefore Market OpensConference Call DateThursday, May 15, 2025Conference Call Time8:00AM ETConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by TriSalus Life Sciences Q1 2025 Earnings Call TranscriptProvided by QuartrMay 15, 2025 ShareLink copied to clipboard.There are 10 speakers on the call. Operator00:00:00Good morning and welcome to the Trisales Life Sciences First Quarter twenty twenty five Earnings Conference Call. Currently, all participants are on a listen only mode. We will be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Alex Grossman, associate director with LifeSci Advisors. Operator00:00:27Please go ahead. Speaker 100:00:31Thank you, operator, and thank you all for participating in today's call. Joining me today from Trisales Life Sciences are Mary Zella, President and Chief Executive Officer James Young, Chief Financial Officer and Doctor. Richard Marshall, Medical Director. Ms. Zella will provide an overview of company's first quarter results and strategy for the balance of the year, and then Jim will review the financial results for the quarter in detail. Speaker 100:00:57Doctor. Marshall will join the call to help address questions from the covering analysts. Earlier this morning, Trysalis released its financial results for the quarter ended 03/31/2025. A copy of this press release is available on the Trysalis website. Before we begin, I would like to remind you that management will make statements during this call that includes forward looking statements within the meaning of federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Reform Act of 1995. Speaker 100:01:29Any statements contained in this call other than statements of historical fact are forward looking statements. All forward looking statements including, without limitation, statements relating to our sales and operating trends, business and hiring prospects, financial and revenue expectations, and future product development and approvals are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties, including the impact of macroeconomic conditions and global events that could cause actual results or events to materially differ from those anticipated or implied by these forward looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 10 Q on file with the SEC and available on EDGAR and in our other reports filed periodically with the SEC. Speaker 100:02:29Trisales disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward looking statements, whether because of new information, future events or otherwise. This conference call contains time sensitive information and is accurate only as of the live broadcast today, 05/15/2025. And with that, I'll turn the call over to Mary. Speaker 200:02:54Good morning, everyone, and thank you for joining us today. In the first quarter, TRISALAS continued to make meaningful progress on its strategic priorities. These include growing market share for TriNav in the liver embolization market, advancing our technology pipeline, exploring new applications for pressure enabled drug delivery or PEDD, and preparing nalatolimod for a pharmaceutical partnership across multiple indications. We achieved several key milestones in Q1 that lay the foundation for sustained momentum in 2025 and beyond. We believe we're just beginning to realize the full potential of over a decade of hard work, work that now positions us for multiple commercial and clinical catalysts in the coming year. Speaker 200:03:42Importantly, with the completion of Phase I trials for nalatolimod, we're shifting to a partnership focused strategy. This transition allows us to eliminate all development expense on nalotolimod by the end of the year, yet preserve the long term value of that program while concentrating our internal resources on the immediate and broader opportunity within our PEDD technology platform. From a commercial perspective, we maintained strong momentum in the quarter, gaining further penetration in the complex liver embolization market, while also expanding our technology into new clinical settings. For our first quarter of twenty twenty five, we delivered $9,200,000 in net sales, a 42% increase compared to Q1 twenty twenty four, and 11% sequential gain over Q4 twenty twenty four. Our strategy remains grounded in five core areas. Speaker 200:04:43Number one, driving adoption of PEDD across a broad range of solid tumors, advancing new clinical applications for TriNav, improving manufacturing and gross margins, expanding our product portfolio, most recently with TriNav LD and TriGuide, and continuing to build a high growth scalable organization. Now let me walk you through some of the key accomplishments from the quarter. First, on market leadership and revenue growth, our results for the quarter position us as one of the fastest growing med tech companies in the interventional oncology space. Second, we continue to generate compelling real world data. At the Society of Interventional Oncology annual meeting, we presented updated health economic and outcome research. Speaker 200:05:35In an analysis of over six hundred PEDD treated patients compared to sixteen thousand non PEDD patients, we saw statistically significant reductions in thirty day inpatient admissions, improved fatigue outcomes, and cost savings for providers. These findings are powerful. They reinforce that interventional radiologists are choosing TriNav for their sickest patients, yet they're seeing tangential benefits. Third, we continue to grow our commercial footprint. In Q1, we increased the number of unique ordering counts by 39% versus Q1 twenty twenty four, adding 32 new accounts in the quarter while also seeing increased utilization per account. Speaker 200:06:21This speaks to both deepening engagement and expanding our reach. Fourth, we made a major step forward in reimbursement. April 1. The Centers for Medicare and Medicaid Services issued a HCPCS code C8004 providing coverage for mapping procedures using TriNet. This means clinicians can now use TriNet for both treatment and planning and delivery in radioembolization. Speaker 200:06:47In effect, this doubles the reimbursable use of our technology for Y90 and supports broader adoption. Fifth, at FIO we also shared interim data from the TRI Fi Y90 study. This study addressed the poor correlation between MMA mapping and microsphere delivery, which has been a longstanding challenge in Y90 or radioembolization therapy. The use of TriNab for both phases showed improved concordance suggesting a more precise and reliable therapeutic approach. The study has closed and we're preparing the full dataset for publication. Speaker 200:07:25Beyond liver cancer, we're also exploring new clinical applications for TriNav. In Q1, we launched the PROTECT Registry, a multicenter effort led by Sarasota, Memorial, and other clinical sites evaluating PDEDD for patients with thyroid nodules or goiters who are not candidates for surgery, radioiodine, or ablation. The goal is to assess disease related quality of life, thyroid function, other outcomes following PEDD based thyroid artery embolization. This novel approach called PED TAE was pioneered by Doctor. Juan Camacho, and Doctor. Speaker 200:08:08Camacho has now treated over 40 patients and has presented outcomes at NASET and SAR, and we're encouraged by the growing interest in this application. In terms of product innovation, we launched TriNav Large and TriGuide, expanding PEDD into larger vessels. These additions support deeper penetration of the liver market and open up new procedural opportunities. We're also pleased to note that following a successful market evaluation, we will soon be initiating the full launch of TriNav Flex, formerly known as TriNav two point zero. TriNav Flex demonstrated to deliver improved trackability and is an important addition to our PEDD portfolio, providing interventional radiologists with a device specifically designed to treat torturous vascular anatomy. Speaker 200:09:01On the nalotolimod front, we successfully completed phase one trials in multiple liver tumor types, including metastatic, uveal melanoma, HCC and cholangiocarcinoma. Additionally, we completed enrollment in PERIO three, our phase one study of nalotolimod in locally advanced pancreatic cancer. We expect final data in the second half of twenty twenty five. As we wind down these trials, we're closing clinical sites and preparing final reports, laying the groundwork for a potential pharmaceutical partnership. With this shift, we also expect a significant reduction in R and D spend, particularly in the second half of the year, and no further spend in 2026. Speaker 200:09:45Now let me touch on our financial position. Subsequent to the end of Q1, we raised approximately $22,000,000 in gross proceeds through a private placement. This additional capital strengthens our balance sheet and provides the resources needed to invest in further commercial resources, pursue new clinical applications, and expand our market opportunity. Equally important, we reached agreement with 55% of our preferred shareholders to implement an exchange offer, converting preferred shares to common stock. This simplifies our capital structure, removes the upcoming reset provision scheduled for July 2027, and better aligns our long term investor base. Speaker 200:10:29Looking ahead, we're entering the rest of 2025 with strong tailwinds. Our strategic priorities are clear. Deepening penetration in the liver embolization market, capitalizing on full reimbursement for both mapping and treatment, advancing TriNav Flex and TriNav Large, generating and publishing new HEOR and clinical data, and completing study reports and readouts for nalotolimod to allow partnering discussions. We believe TriNet is on a clear path to becoming the standard of care for complex embolization. Our focus is on strengthening the clinical evidence, engaging key societies, and building sustained commercial growth. Speaker 200:11:12We want to confirm our guidance of at least 50% revenue growth to reflect our confidence in the momentum we're building. While we remain committed to improving EBITDA performance, we're also making a deliberate decision to invest in strategic areas of the business. Specifically, we're allocating capital to accelerate development of new clinical applications of our core technology, as well as expanding our commercial organization, which we believe will expand our addressable market and drive significant long term value. As a result, we do not anticipate being EBITDA positive or cash flow positive in 2025. In summary, our refined guidance reflects a company that is scaling, investing in its future, and focused on creating meaningful value for patients, providers, and shareholders alike. Speaker 200:12:03As always, we remain a science driven organization committed to putting patients at the center of everything we do. Our progress is making a real difference for people living with liver, pancreatic, and other solid tumors. Finally, I want to thank our team. Their passion, dedication and relentless focus on innovation are what makes this company special. I'm grateful to all of our employees and shareholders for your continued support. Speaker 200:12:29We look forward to sharing more in the quarters ahead. And now I'll turn it over to our CFO, Jim Young, for the financial update. Speaker 300:12:37Good morning, everyone, and thank you, Mary. I am pleased to announce that Trysalis achieved the following results in the first quarter that ended March thirty first of twenty twenty five. Our revenue solely driven by the success of the TriNav device in the represents a 42 percent increase compared to the same period in 2024 and is also up 11% sequentially compared to the fourth quarter. Trisalis has a track record of growth as illustrated on slide one, which shows the company growing at a compound annualized growth rate of approximately 50% since the launch of our product in 2020. These results can be attributed to several factors including the adoption of TriNav in new accounts, increased utilization of existing accounts and the continued expansion of our sales force all of which have led to an increase in our market share to 10% of the liver taste and tear procedures. Speaker 300:13:37Our gross margin profile of 84% in the first quarter of twenty twenty five is slightly unfavorable compared to 85% in the first quarter of twenty twenty four. This unfavorable margin profile in 2025 can be attributed to decreased factory volumes associated with a factory clean room expansion, which has now been completed. We believe our facility in Westminster, Colorado has the capacity to support our growth over the next five years with minimal capital investment. In terms of our investments in research and development expenses for the first quarter of twenty twenty five totaled $3,300,000 a decrease of 44% from the first quarter of twenty twenty four. As Mary noted earlier, we expect our clinical costs in 2025 to continue to decrease due to completion of naletolimod patient enrollment in all perio studies. Speaker 300:14:32General and administrative expenses for the first quarter of twenty twenty five totaled 5,000,000 representing an increase of over 7% compared to the fourth quarter of twenty twenty four primarily due to the timing of audit and legal expenses. Our operating losses for the first quarter of twenty twenty five totaled $7,300,000 compared to losses of $11,700,000 in the first quarter of twenty twenty four. The decreased losses in 2025 can be primarily attributed to increased sales and reduced research and development expenses as noted earlier. We have also published adjusted EBITDA results for the first time in our earnings release. We believe this is an important and useful measure of performance and we will continue to publish going forward. Speaker 300:15:22Our adjusted EBITDA losses for the first quarter of twenty twenty five totaled $5,500,000 compared to losses of 10,400,000.0 in the first quarter of twenty twenty four. Decreased losses in 2025 can be primarily attributed to increased sales, reduced research and development expenses and higher non cash stock compensation expense in 2025. At quarter end, we have $13,000,000 of cash and cash equivalents. Subsequent to the end of the first quarter, we raised $22,000,000 in gross proceeds from a private placement. We believe these amounts provide us sufficient liquidity to fund operations throughout 2025 and as noted previously, we expect to become cash flow positive in early twenty twenty six. Speaker 300:16:10And now I'll turn the call back to Mary for closing remarks. Speaker 200:16:14Thank you, Jim, and thank you to everyone who joined us on today's call. At Trimalis, we're proud of the progress we made in the first quarter of twenty twenty five. We continue to advance the adoption of our TriNav technology across a growing number of clinical settings, and we've taken important steps to position nalotomimod for potential partnerships that can unlock its full value. These achievements are helping us to shape an exciting future for Trisales, and we're energized by the momentum we're building. With that, I'll be happy to open the line for questions. Speaker 200:16:46We appreciate your interest and look forward to your insights. Thank you. Operator00:16:52Thank The first question comes from Justin Walsh with Jones Trading. Your line is open. Speaker 400:17:12Hi, thanks for taking the question. I'm wondering what we should be looking for in the perio three readout. Curious what you think would be an attractive outcome to for potential partners. Speaker 200:17:24Sure. So let me remind you, this was a phase one dose ranging trial, and there were two components of it that we were studying. Number one, this was a new technology that, a novel technology that's never been used before. So this was our PEDD device that accesses the pancreatic tumor through the venous vasculature, which no one has done. And we concluded after 38 different infusions that we have a device that is highly functioning, easy to use for the physician, and performs very, very well. Speaker 200:18:03So that was number one. We have a device that works very well with very minimal side effects. Number two, what we're looking for in the data is this was a dose ranging study. We collected quite a bit of correlative information, which is unusual for this type of a trial. We had tumor tissue samples pre and post, measured a lot of cytokine levels pre and post, and followed the patients for quite some time. Speaker 200:18:32We also had secondary endpoints of overall survival in all their treatment. I don't have the final data yet. We have a couple patients that were enrolled in the last few months of the year. So we will review that data. We know that we have about fifty percent of the patients out of the 12 patients that were enrolled. Speaker 200:18:52There were actually 13 patients, one never received treatment. But of 12 patients, about fifty percent of the patients are still alive, which is actually a good sign. And one of the key things they're looking for is really, can this drug, nalotolimod, stimulate the innate environment of the pancreatic tumor? And that's what, in conversations with various pharmaceutical partners, just how profoundly does that occur and after two infusions and the overall safety profile. Those are the two areas of focus for pharma partners. Speaker 200:19:27Does that help? Speaker 400:19:28Yes, does. And maybe one very quick follow-up. I'm just curious if you're seeing interest in nalatolimod sort of in and of itself, or if it's still is in conjunction with the use of try NAV and just some thoughts if you do find some partners here, if your expectation that your role would be assuming that they do trials that combined with TriNav essentially providing TriNav and then possibly receiving royalties from nalotolimod? Just curious how you're thinking about possible structuring potential I'm sure a lot of that will be dependent on the partner, of course. Speaker 200:20:07Right. So number one, nalotolimod really can't be infused intravascularly. This would actually create can't be delivered IV. That would create cytokine storm. Obviously, could be delivered via needle injection. Speaker 200:20:23And what we saw that that was really suboptimal. So the way that we feel that really optimizes nalatolimod's performance is through our technology, and that's why how it would be developed. And that's the data that they'll be looking at across the liver and in the pancreas. And the goal would be is that we would partner with them. We would handle, obviously, the whole procedural aspect, and hopefully potentially participate on the drug side. Speaker 200:20:50We think that PEDD is really a platform for a whole range of different drugs to be delivered in this manner. And this would be where we could deliver directly to the tumor site, as well as this drug would be administered systemically, and we think that could have a profound impact in terms of outcomes. And that's what is really the interest of various pharma partners. How do you get a higher concentration in the tumor? It doesn't take away from systemic delivery, which is addressing the micro metastases, but can you improve outcomes substantially by that combination? Speaker 400:21:24Great, thanks for taking the questions. Operator00:21:27And the next question comes from Ross Osborne with Cantor Fitzgerald. Your line is open. Speaker 500:21:35Hi, thanks for taking our questions, and congrats on the progress. Starting off, would be curious to hear any feedback so far on Tri LARGE. And what types of patients and clinicians are you seeing initial adoption with? Speaker 200:21:47Know what, frankly, the TriNav large is performing really well. I'll hand that call over to Doctor. Marshall, who probably would even have a better insight into the larger vessel size patients. But where we hear the most of the adoption is just larger tumors. We're also seeing it in uterine fibroid embolization. Speaker 200:22:08But Doctor. Maraslow, you want to comment further? Speaker 600:22:10Yes. First of all, morning, thanks for letting me participate. So I actually used the TriNev large yesterday. And where we're seeing physicians use it most it's mostly in the liver and it's for tumors that are fed by larger arteries. So the size range for trying that large is an artery that's three to five millimeters in diameter. Speaker 600:22:34That's larger than a standard hepatic artery. So tumors that are really vascular like hepatocellular carcinoma, neuroendocrine tumors and then multifocal where there are multiple tumors in the same vascular bed. And we're seeing great results with it. Physicians are happy with it because they're able to treat a larger area. And as Mary mentioned we are seeing its use in uterine fibroid embolization. Speaker 600:23:02Its larger capacity allows physicians to deliver more drug faster. And so those are the two primary uses. We are seeing increased use in the thyroid where some of those arteries are larger because of larger goiters. And I think that's a good synopsis of how it's being used now. Speaker 500:23:28Great. I appreciate the color there. And then in terms of your clean room expansion, when were those initiatives complete? And how should we think about cadence for the balance of the year in the gross margin line? Speaker 300:23:40Yes, I can take that one, Ross. Thank you. It was completed in March. So it was probably kind of February, March time frame and obviously had a negative impact on gross margin. So now that it's completely done, we're kind of back to full scale progress. Speaker 300:23:56And I think our gross margins should definitely trend back up to kind of where they were previously. So I would expect that number to continue to improve for sure in the second quarter. And then depending on how good the second quarter is, we still may get even better. But I would expect kind of upper 80%. We've hit 90% in the past. Speaker 300:24:19That would be a great quarter, but upper 80s is kind of ballpark we should be playing in from a margin perspective. Does that answer it, Ross? Speaker 500:24:28Yes. Perfect. Thanks for taking our questions. Congrats on progress. Speaker 200:24:32Thank you. Thanks. Operator00:24:34The next question will come from Frank Takkinen with Lake Street Capital Markets. Your line is now open. Speaker 700:24:44Great. Thanks for taking the questions. Congrats on all the progress. I was hoping to start with cadencing of revenue. Obviously, in light of the financing, you're increasing the sales force. Speaker 700:24:53So maybe how does that impact the growth rate as we go through the back half of the year to accelerate to achieve that 50% growth for the full year? Speaker 200:25:02Yeah. So one of the things of the whole private placement was really twofold. The goals were twofold. Number one, we're seeing just incredible momentum. We know that if we could add sales resources, marketing resources, we could potentially even grow even higher than our current growth rate. Speaker 200:25:23And so we plan to add sales resources starting now. We had a number of positions that we were targeting that we wanna fill rapidly. We'll probably layer them in over the next couple months, and you'll see the biggest impact in the fourth quarter, but really the significant impact will be in 2026. Usually it takes about three to six months for reps to really get their footing and get on board and start driving meaningful volume. So you'll see that being peppered in over the second half of this year. Speaker 700:25:59Got it. That's helpful. And then maybe just for the second one, I was hoping you could comment on maybe any feedback you've heard from physicians on the new mapping code. Know when we spoke with physicians, that was one of the key issues that they were speaking to of using the device more frequently in their practices. So maybe what's kind of early feedback, understanding it's only been forty five days since that's been effective, but what's early feedback, and how should we kind of think about the impact of that? Speaker 200:26:25Really favorable. I will tell you that I think, as a company, I'm not sure we fully appreciated that that was holding us back, but we're really starting to see people use this much more predominantly and consistently. So very favorable feedback across the board. So we're very excited about it. I think it now gives us full reimbursement. Speaker 200:26:48And now with our product portfolio, we have a full vessel range size. So it allows physicians to adopt it much more broadly than how they were before. I think it was more selective. Now that we have the full portfolio and a full reimbursement, you know, they're very comfortable now using it in a much broader set of patients. Speaker 500:27:08And if I could add, Speaker 600:27:09I think physicians, they're no longer worrying too much about, you know, can I use this in this setting? It's much more straightforward. They're treating disease based upon the disease and not worrying so much about reimbursement. Speaker 700:27:22Got it. That's helpful. Thanks. Operator00:27:27And our next question will come from Suraj Kalia with Oppenheimer. Your line is open. Speaker 800:27:35Hi, Mary. Can you hear me all right? Speaker 200:27:37Yep. Good. Good to hear your voice. Mary, Speaker 800:27:41congrats on all the progress. Hey, Mary on Neltalimod, I'm curious, One is the drug's PK profile. Right? The 12 patients that y'all have done, how would you characterize the relative balance between the drug's PK profile and the delivery mechanisms, titrations schedule across the patients. Do we know which side that is tilted more? Speaker 800:28:09I guess what I'm really trying to understand is, you know, what leverage would you all have eventually as you all start your discussions with strategic partners? Speaker 200:28:21Yeah, so you know what's interesting? We actually saw this in our metastatic uveal melanoma trial, that melatonin had very long term effects. And that you actually saw late favorable effects, even eight months, ten months out. So we don't know exactly why that is the case, but we've seen that across the board. And we know that this drug and its effects and we're going to have some publications come out soon with hypotheses around the mechanism of action. Speaker 200:29:00But because it's a type C and its effect on myeloid derived suppressor cells, there's a hypothesis that it has a much longer duration of effect on the immune system. So I think that's just our early view of it. This is a phase one trial, so there's still so much to know about that. But I think what's the feedback that I've received from various people that I've spoken to, and probably what was intrigued other parties the most was, particularly in our uveal melanoma, metastatic melanoma trial, was that naletolimod actually helped patients who were checkpoint refractory. So obviously, that's a very big focus for big pharma on, you know, can you make a patient who's not receptive to a checkpoint receptive? Speaker 200:29:49And so I think that was a big focus of their interest in nalotolimod. Does that help? Speaker 800:29:54Yep. Yep. Fair enough. And Mary, as a follow-up, the 42% growth in TriNet, right, it's quite impressive, especially in the current environment. And I'm curious if you could give us some additional color. Speaker 800:30:07You know, the 42%, how broad based, deep, just some additional granularity on utilization characteristics would be great. I know you all said 32 new accounts added, but just kinda give us a broader picture to help us better understand the cadence as we walk through the quarter. Thanks again and Yes. Speaker 200:30:28Typically, we our first quarter is generally our lower first quarter. We usually come off a very strong fourth quarter, which we did. And then we see it build throughout the year. I think one of the things that's been a catalyst for us is also getting the additional code, which we had not planned for actually in our planning for 2025. We've really seen a nice improvement in momentum starting once the code was announced. Speaker 200:30:56But what you'll see is throughout the year, we start to see utilization generally increase significantly. The part of that is due to the big focus change that we had from last year. Last year, we were just trying to get into new accounts. So we had a big focus about getting through back approvals, getting into as many different hospital accounts as possible. This year, we're in a very significant number of hospitals that are high volume. Speaker 200:31:24Our big focus is on driving utilization and generating utilization beyond just one IR, but into multiple IRs across consistent patient populations. So we'll start to see that utilization grow throughout the year. And we've actually built up our plan in pretty ground up way, where we look at each every territory, where the physicians are using it, how that utilization is changing. So we feel very comfortable about our guidance around the 50% growth. Hopefully that helps. Speaker 200:31:56I don't know, Jim, if you wanted to add anything further. Speaker 900:31:59No, I think that covers it. Speaker 300:32:00I think the big focus, you know, last year, like Mary said, was the getting a lot of new accounts through back approval. And now the focus is more, you know, geared towards utilization. So I think she summed up well. Speaker 600:32:12And I also think we have a lot better data that our physicians are using, in particular our healthcare economics outcomes research that demonstrates cost savings with use of TriNet down the road. So I think people appreciate that the device is actually useful from that from an economic standpoint. Speaker 800:32:33Appreciate it. Operator00:32:36The next question will come from William Plowenick with Canaccord. Your line is open. Speaker 900:32:43Great, thanks. Good morning. Couple of questions if I could. Just first, just on the kind of commercial organization on the sales force, what was the number at the end of the quarter? Where do you look to go by the end of the year? Speaker 900:33:02Investing in this? Just trying to get some data behind it. And then on the new on the accounts, you had a big number of new accounts. But what's the net account number as you exited Q1? And then I have a follow-up. Speaker 200:33:17Sure. So we currently have, and we don't split out kind of we have clinical specialists and reps, and we have about 45. And then we have management. Our goal is over the next eighteen months, I'd like to get to about between sixty and seventy. What we've been trying to do, Bill and this is something that we've learned along the way. Speaker 200:33:43We hired probably too aggressively years ago, and we now really understand what the phenotype of the sales representative that we need. And so we've been much more thoughtful about adding that type of rep. They have to have a blend of clinical skills, technical skills, but they also need to know how to build a new therapy. And we have a wide array of different applications. So that's a more targeted type of representative that we're looking for. Speaker 200:34:10So we'll add that over the next eighteen to twenty four months. That's our goal. And we've been very thoughtful about where to place them, where the volume is, and how to balance that among the different applications. And that's going be a big part of it. Does that help? Speaker 900:34:27Yes. And then on the accounts, Jim? Speaker 300:34:29Yeah, I think the accounts, it was in the neighborhood of right around 300 at the end of the year. And we added about 30 or 40 this quarter. So it's kind of the low to mid 300s. Speaker 900:34:45And then on the updated guidance and the push out of profitability, just how much of that is a function of the commercial organization expansion versus the investment in thyroid and some of the other programs? Speaker 100:35:03Yes, it's probably Speaker 200:35:04about 60 expansion of the commercial organization, and then about 40% investment in new applications. We're gonna start a registry test trial in two new applications. One is in genicular artery embolization, which we think is a really promising high growth area for us. We're also going to do a registry in uterine fibroid embolization. And our goal is ultimately across a wide array of different applications, is build this registry data that allows us to refine what are the clear endpoints and differentiation of TriNav in these procedures, collect outcome data, and collect data that ultimately we could submit for inclusion into the guidelines. Speaker 200:35:48And so those registries are not as costly as a significant clinical trial, but it can function like a clinical trial because we can compare to standard of care, although we can bill for therapy as those patients are enrolled. And we'll have multiple different registries by the end of the year. And then our goal in 2026 is to add some additional registries in some of the other areas and new applications that we're exploring right now. Speaker 900:36:17Okay. And then the last question, if I can sneak one in. Just on the second quarter, you're guiding 50% for the year. The Street's sitting at, I think, 10.4% were 10.5 So up a little over a million. Yeah. Speaker 900:36:32Is that something I mean, this everything's back half loaded right now. You know, are you comfortable with the second quarter consensus at this point? Speaker 600:36:42Yes. Thanks for taking my questions. Speaker 200:36:43Yes. Operator00:36:48And our next question will come from Jason Witz with Roth. Your line is now open. Speaker 600:36:56Hi, thanks for taking the questions. Mostly follow ups here. First off, on the sales force expansion, does that get you to basically what you would consider a full penetration in terms of covering the entire country? Speaker 200:37:09No, not yet. There's roughly about 400 hospitals that represent about 80% of the procedural volume. So I would say that over the next eighteen months, that will get us there if we fill all of those reps. But one of the other things that we're considering and we're working through right now is these new applications offer a lot of volume, and so we're going back and looking at our procedural model, and does these new applications and the utilization modify some of those plans? So I don't have a complete answer on that, particularly with thyroid and GAE, and some of these other new procedures which are done in different locations that may modify that a little bit. Speaker 200:37:53So that's why I'm not answering that specifically. We'll have a better plan and understanding of that over the next couple months. Speaker 600:38:00Okay, that's fair. And did you break out sort of between taste and tear, sort of what the trends have been in terms of usage right now? Speaker 200:38:12Maybe I'll have Doctor. Marshall talk about that. You know, we see the data. It's generally been about fifty-fifty, but we know that it's skewing a little bit more towards radio embolization. Doctor. Speaker 200:38:22Marshall, you want to talk about that? Speaker 600:38:24Yep. I can talk about the overall feeling with our new CPT code for mapping. And I think that's really generating a lot of buzz among physicians. And I think as we look at the market as a whole care is trending way higher than take it. The care has become the number one local regional therapy to keep patients on liver transplant list. Speaker 600:38:50And so I think we'll see that continue with the use of TriNav. They'll follow that path. For TACE, we still see very heavy use in things like neuroendocrine tumor embolization. And while that's a small subset of patients these patients get numerous embolizations so one patient might receive four or six treatments over their lifespan. The growth is definitely in tear at the moment. Speaker 600:39:18Got it. Thank you. I'll jump back in queue. Thank you very much. Operator00:39:21I am showing no further questions at this time. I would now like to turn the call back over to Mary for closing remarks. Speaker 200:39:36Okay. Thank you, everyone. I really appreciate you joining the call, and thank you for all your questions. Operator00:39:43This concludes today's conference call. Thank you for participating. You mayRead morePowered by Conference Call Audio Live Call not available Earnings Conference CallTriSalus Life Sciences Q1 202500:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) TriSalus Life Sciences Earnings HeadlinesTriSalus Life Sciences Reports First Quarter 2025 Results and Provides Updated 2025 GuidanceMay 15 at 7:00 AM | businesswire.comTriSalus Life Sciences to Host First Quarter 2025 Financial Results Conference CallMay 12 at 5:13 PM | businesswire.comMusk’s Project Colossus could mint millionairesI predict this single breakthrough could make Elon the world’s first trillionaire — and mint more new millionaires than any tech advance in history. And for a limited time, you have the chance to claim a stake in this project, even though it’s housed inside Elon’s private company, xAI.May 15, 2025 | Brownstone Research (Ad)TriSalus Life Sciences Announces $22.0 Million Private Placement Preliminary Q1 2025 Unaudited Financial ResultsApril 30, 2025 | finance.yahoo.comTriSalus Life Sciences: Optimistic Guidance For 2025, But There Are Still RisksMarch 30, 2025 | seekingalpha.comTrisalus outlines 50% revenue growth target for 2025 driven by TriNav expansion and new market penetrationMarch 27, 2025 | msn.comSee More TriSalus Life Sciences Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like TriSalus Life Sciences? Sign up for Earnings360's daily newsletter to receive timely earnings updates on TriSalus Life Sciences and other key companies, straight to your email. Email Address About TriSalus Life SciencesTriSalus Life Sciences (NASDAQ:TLSI), a medical technology company, researches, develops, and sells drug delivery technologies and immune-oncology therapeutics for the treatment of liver and pancreatic cancer. The company offers Pressure Enabled Drug Delivery infusion systems, such as the TriNav infusion system, which is used in transarterial radioembolization and chemoembolization procedures for patients with liver cancer and metastases; and the Pancreatic Retrograde Venous Infusion device, which is in Phase 1 clinical trial, for locally advanced pancreatic cancer. It also develops nelitolimod, an investigational immunotherapeutic in Phase 1 clinical trial for the treatment of uveal melanoma with liver metastases, hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and locally advanced pancreatic ductal adenocarcinoma. The company serves interventional radiologists, IR technicians, medical oncologists, nursing support, value analysis committee staff, and patients through its sales representatives and sales managers. TriSalus Life Sciences, Inc. was founded in 2009 and is headquartered in Westminster, Colorado.View TriSalus Life Sciences ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles D-Wave Pushes Back on Short Seller Case With Strong EarningsAppLovin Surges on Earnings: What's Next for This Tech Standout?Can Shopify Stock Make a Comeback After an Earnings Sell-Off?Rocket Lab: Earnings Miss But Neutron Momentum HoldsWhy Nearly 20 Analysts Raised Meta Price Targets Post-EarningsOXY Stock Rebound Begins Following Solid Earnings BeatMonolithic Power Systems: Will Strong Earnings Spark a Recovery? 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There are 10 speakers on the call. Operator00:00:00Good morning and welcome to the Trisales Life Sciences First Quarter twenty twenty five Earnings Conference Call. Currently, all participants are on a listen only mode. We will be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Alex Grossman, associate director with LifeSci Advisors. Operator00:00:27Please go ahead. Speaker 100:00:31Thank you, operator, and thank you all for participating in today's call. Joining me today from Trisales Life Sciences are Mary Zella, President and Chief Executive Officer James Young, Chief Financial Officer and Doctor. Richard Marshall, Medical Director. Ms. Zella will provide an overview of company's first quarter results and strategy for the balance of the year, and then Jim will review the financial results for the quarter in detail. Speaker 100:00:57Doctor. Marshall will join the call to help address questions from the covering analysts. Earlier this morning, Trysalis released its financial results for the quarter ended 03/31/2025. A copy of this press release is available on the Trysalis website. Before we begin, I would like to remind you that management will make statements during this call that includes forward looking statements within the meaning of federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Reform Act of 1995. Speaker 100:01:29Any statements contained in this call other than statements of historical fact are forward looking statements. All forward looking statements including, without limitation, statements relating to our sales and operating trends, business and hiring prospects, financial and revenue expectations, and future product development and approvals are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties, including the impact of macroeconomic conditions and global events that could cause actual results or events to materially differ from those anticipated or implied by these forward looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 10 Q on file with the SEC and available on EDGAR and in our other reports filed periodically with the SEC. Speaker 100:02:29Trisales disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward looking statements, whether because of new information, future events or otherwise. This conference call contains time sensitive information and is accurate only as of the live broadcast today, 05/15/2025. And with that, I'll turn the call over to Mary. Speaker 200:02:54Good morning, everyone, and thank you for joining us today. In the first quarter, TRISALAS continued to make meaningful progress on its strategic priorities. These include growing market share for TriNav in the liver embolization market, advancing our technology pipeline, exploring new applications for pressure enabled drug delivery or PEDD, and preparing nalatolimod for a pharmaceutical partnership across multiple indications. We achieved several key milestones in Q1 that lay the foundation for sustained momentum in 2025 and beyond. We believe we're just beginning to realize the full potential of over a decade of hard work, work that now positions us for multiple commercial and clinical catalysts in the coming year. Speaker 200:03:42Importantly, with the completion of Phase I trials for nalatolimod, we're shifting to a partnership focused strategy. This transition allows us to eliminate all development expense on nalotolimod by the end of the year, yet preserve the long term value of that program while concentrating our internal resources on the immediate and broader opportunity within our PEDD technology platform. From a commercial perspective, we maintained strong momentum in the quarter, gaining further penetration in the complex liver embolization market, while also expanding our technology into new clinical settings. For our first quarter of twenty twenty five, we delivered $9,200,000 in net sales, a 42% increase compared to Q1 twenty twenty four, and 11% sequential gain over Q4 twenty twenty four. Our strategy remains grounded in five core areas. Speaker 200:04:43Number one, driving adoption of PEDD across a broad range of solid tumors, advancing new clinical applications for TriNav, improving manufacturing and gross margins, expanding our product portfolio, most recently with TriNav LD and TriGuide, and continuing to build a high growth scalable organization. Now let me walk you through some of the key accomplishments from the quarter. First, on market leadership and revenue growth, our results for the quarter position us as one of the fastest growing med tech companies in the interventional oncology space. Second, we continue to generate compelling real world data. At the Society of Interventional Oncology annual meeting, we presented updated health economic and outcome research. Speaker 200:05:35In an analysis of over six hundred PEDD treated patients compared to sixteen thousand non PEDD patients, we saw statistically significant reductions in thirty day inpatient admissions, improved fatigue outcomes, and cost savings for providers. These findings are powerful. They reinforce that interventional radiologists are choosing TriNav for their sickest patients, yet they're seeing tangential benefits. Third, we continue to grow our commercial footprint. In Q1, we increased the number of unique ordering counts by 39% versus Q1 twenty twenty four, adding 32 new accounts in the quarter while also seeing increased utilization per account. Speaker 200:06:21This speaks to both deepening engagement and expanding our reach. Fourth, we made a major step forward in reimbursement. April 1. The Centers for Medicare and Medicaid Services issued a HCPCS code C8004 providing coverage for mapping procedures using TriNet. This means clinicians can now use TriNet for both treatment and planning and delivery in radioembolization. Speaker 200:06:47In effect, this doubles the reimbursable use of our technology for Y90 and supports broader adoption. Fifth, at FIO we also shared interim data from the TRI Fi Y90 study. This study addressed the poor correlation between MMA mapping and microsphere delivery, which has been a longstanding challenge in Y90 or radioembolization therapy. The use of TriNab for both phases showed improved concordance suggesting a more precise and reliable therapeutic approach. The study has closed and we're preparing the full dataset for publication. Speaker 200:07:25Beyond liver cancer, we're also exploring new clinical applications for TriNav. In Q1, we launched the PROTECT Registry, a multicenter effort led by Sarasota, Memorial, and other clinical sites evaluating PDEDD for patients with thyroid nodules or goiters who are not candidates for surgery, radioiodine, or ablation. The goal is to assess disease related quality of life, thyroid function, other outcomes following PEDD based thyroid artery embolization. This novel approach called PED TAE was pioneered by Doctor. Juan Camacho, and Doctor. Speaker 200:08:08Camacho has now treated over 40 patients and has presented outcomes at NASET and SAR, and we're encouraged by the growing interest in this application. In terms of product innovation, we launched TriNav Large and TriGuide, expanding PEDD into larger vessels. These additions support deeper penetration of the liver market and open up new procedural opportunities. We're also pleased to note that following a successful market evaluation, we will soon be initiating the full launch of TriNav Flex, formerly known as TriNav two point zero. TriNav Flex demonstrated to deliver improved trackability and is an important addition to our PEDD portfolio, providing interventional radiologists with a device specifically designed to treat torturous vascular anatomy. Speaker 200:09:01On the nalotolimod front, we successfully completed phase one trials in multiple liver tumor types, including metastatic, uveal melanoma, HCC and cholangiocarcinoma. Additionally, we completed enrollment in PERIO three, our phase one study of nalotolimod in locally advanced pancreatic cancer. We expect final data in the second half of twenty twenty five. As we wind down these trials, we're closing clinical sites and preparing final reports, laying the groundwork for a potential pharmaceutical partnership. With this shift, we also expect a significant reduction in R and D spend, particularly in the second half of the year, and no further spend in 2026. Speaker 200:09:45Now let me touch on our financial position. Subsequent to the end of Q1, we raised approximately $22,000,000 in gross proceeds through a private placement. This additional capital strengthens our balance sheet and provides the resources needed to invest in further commercial resources, pursue new clinical applications, and expand our market opportunity. Equally important, we reached agreement with 55% of our preferred shareholders to implement an exchange offer, converting preferred shares to common stock. This simplifies our capital structure, removes the upcoming reset provision scheduled for July 2027, and better aligns our long term investor base. Speaker 200:10:29Looking ahead, we're entering the rest of 2025 with strong tailwinds. Our strategic priorities are clear. Deepening penetration in the liver embolization market, capitalizing on full reimbursement for both mapping and treatment, advancing TriNav Flex and TriNav Large, generating and publishing new HEOR and clinical data, and completing study reports and readouts for nalotolimod to allow partnering discussions. We believe TriNet is on a clear path to becoming the standard of care for complex embolization. Our focus is on strengthening the clinical evidence, engaging key societies, and building sustained commercial growth. Speaker 200:11:12We want to confirm our guidance of at least 50% revenue growth to reflect our confidence in the momentum we're building. While we remain committed to improving EBITDA performance, we're also making a deliberate decision to invest in strategic areas of the business. Specifically, we're allocating capital to accelerate development of new clinical applications of our core technology, as well as expanding our commercial organization, which we believe will expand our addressable market and drive significant long term value. As a result, we do not anticipate being EBITDA positive or cash flow positive in 2025. In summary, our refined guidance reflects a company that is scaling, investing in its future, and focused on creating meaningful value for patients, providers, and shareholders alike. Speaker 200:12:03As always, we remain a science driven organization committed to putting patients at the center of everything we do. Our progress is making a real difference for people living with liver, pancreatic, and other solid tumors. Finally, I want to thank our team. Their passion, dedication and relentless focus on innovation are what makes this company special. I'm grateful to all of our employees and shareholders for your continued support. Speaker 200:12:29We look forward to sharing more in the quarters ahead. And now I'll turn it over to our CFO, Jim Young, for the financial update. Speaker 300:12:37Good morning, everyone, and thank you, Mary. I am pleased to announce that Trysalis achieved the following results in the first quarter that ended March thirty first of twenty twenty five. Our revenue solely driven by the success of the TriNav device in the represents a 42 percent increase compared to the same period in 2024 and is also up 11% sequentially compared to the fourth quarter. Trisalis has a track record of growth as illustrated on slide one, which shows the company growing at a compound annualized growth rate of approximately 50% since the launch of our product in 2020. These results can be attributed to several factors including the adoption of TriNav in new accounts, increased utilization of existing accounts and the continued expansion of our sales force all of which have led to an increase in our market share to 10% of the liver taste and tear procedures. Speaker 300:13:37Our gross margin profile of 84% in the first quarter of twenty twenty five is slightly unfavorable compared to 85% in the first quarter of twenty twenty four. This unfavorable margin profile in 2025 can be attributed to decreased factory volumes associated with a factory clean room expansion, which has now been completed. We believe our facility in Westminster, Colorado has the capacity to support our growth over the next five years with minimal capital investment. In terms of our investments in research and development expenses for the first quarter of twenty twenty five totaled $3,300,000 a decrease of 44% from the first quarter of twenty twenty four. As Mary noted earlier, we expect our clinical costs in 2025 to continue to decrease due to completion of naletolimod patient enrollment in all perio studies. Speaker 300:14:32General and administrative expenses for the first quarter of twenty twenty five totaled 5,000,000 representing an increase of over 7% compared to the fourth quarter of twenty twenty four primarily due to the timing of audit and legal expenses. Our operating losses for the first quarter of twenty twenty five totaled $7,300,000 compared to losses of $11,700,000 in the first quarter of twenty twenty four. The decreased losses in 2025 can be primarily attributed to increased sales and reduced research and development expenses as noted earlier. We have also published adjusted EBITDA results for the first time in our earnings release. We believe this is an important and useful measure of performance and we will continue to publish going forward. Speaker 300:15:22Our adjusted EBITDA losses for the first quarter of twenty twenty five totaled $5,500,000 compared to losses of 10,400,000.0 in the first quarter of twenty twenty four. Decreased losses in 2025 can be primarily attributed to increased sales, reduced research and development expenses and higher non cash stock compensation expense in 2025. At quarter end, we have $13,000,000 of cash and cash equivalents. Subsequent to the end of the first quarter, we raised $22,000,000 in gross proceeds from a private placement. We believe these amounts provide us sufficient liquidity to fund operations throughout 2025 and as noted previously, we expect to become cash flow positive in early twenty twenty six. Speaker 300:16:10And now I'll turn the call back to Mary for closing remarks. Speaker 200:16:14Thank you, Jim, and thank you to everyone who joined us on today's call. At Trimalis, we're proud of the progress we made in the first quarter of twenty twenty five. We continue to advance the adoption of our TriNav technology across a growing number of clinical settings, and we've taken important steps to position nalotomimod for potential partnerships that can unlock its full value. These achievements are helping us to shape an exciting future for Trisales, and we're energized by the momentum we're building. With that, I'll be happy to open the line for questions. Speaker 200:16:46We appreciate your interest and look forward to your insights. Thank you. Operator00:16:52Thank The first question comes from Justin Walsh with Jones Trading. Your line is open. Speaker 400:17:12Hi, thanks for taking the question. I'm wondering what we should be looking for in the perio three readout. Curious what you think would be an attractive outcome to for potential partners. Speaker 200:17:24Sure. So let me remind you, this was a phase one dose ranging trial, and there were two components of it that we were studying. Number one, this was a new technology that, a novel technology that's never been used before. So this was our PEDD device that accesses the pancreatic tumor through the venous vasculature, which no one has done. And we concluded after 38 different infusions that we have a device that is highly functioning, easy to use for the physician, and performs very, very well. Speaker 200:18:03So that was number one. We have a device that works very well with very minimal side effects. Number two, what we're looking for in the data is this was a dose ranging study. We collected quite a bit of correlative information, which is unusual for this type of a trial. We had tumor tissue samples pre and post, measured a lot of cytokine levels pre and post, and followed the patients for quite some time. Speaker 200:18:32We also had secondary endpoints of overall survival in all their treatment. I don't have the final data yet. We have a couple patients that were enrolled in the last few months of the year. So we will review that data. We know that we have about fifty percent of the patients out of the 12 patients that were enrolled. Speaker 200:18:52There were actually 13 patients, one never received treatment. But of 12 patients, about fifty percent of the patients are still alive, which is actually a good sign. And one of the key things they're looking for is really, can this drug, nalotolimod, stimulate the innate environment of the pancreatic tumor? And that's what, in conversations with various pharmaceutical partners, just how profoundly does that occur and after two infusions and the overall safety profile. Those are the two areas of focus for pharma partners. Speaker 200:19:27Does that help? Speaker 400:19:28Yes, does. And maybe one very quick follow-up. I'm just curious if you're seeing interest in nalatolimod sort of in and of itself, or if it's still is in conjunction with the use of try NAV and just some thoughts if you do find some partners here, if your expectation that your role would be assuming that they do trials that combined with TriNav essentially providing TriNav and then possibly receiving royalties from nalotolimod? Just curious how you're thinking about possible structuring potential I'm sure a lot of that will be dependent on the partner, of course. Speaker 200:20:07Right. So number one, nalotolimod really can't be infused intravascularly. This would actually create can't be delivered IV. That would create cytokine storm. Obviously, could be delivered via needle injection. Speaker 200:20:23And what we saw that that was really suboptimal. So the way that we feel that really optimizes nalatolimod's performance is through our technology, and that's why how it would be developed. And that's the data that they'll be looking at across the liver and in the pancreas. And the goal would be is that we would partner with them. We would handle, obviously, the whole procedural aspect, and hopefully potentially participate on the drug side. Speaker 200:20:50We think that PEDD is really a platform for a whole range of different drugs to be delivered in this manner. And this would be where we could deliver directly to the tumor site, as well as this drug would be administered systemically, and we think that could have a profound impact in terms of outcomes. And that's what is really the interest of various pharma partners. How do you get a higher concentration in the tumor? It doesn't take away from systemic delivery, which is addressing the micro metastases, but can you improve outcomes substantially by that combination? Speaker 400:21:24Great, thanks for taking the questions. Operator00:21:27And the next question comes from Ross Osborne with Cantor Fitzgerald. Your line is open. Speaker 500:21:35Hi, thanks for taking our questions, and congrats on the progress. Starting off, would be curious to hear any feedback so far on Tri LARGE. And what types of patients and clinicians are you seeing initial adoption with? Speaker 200:21:47Know what, frankly, the TriNav large is performing really well. I'll hand that call over to Doctor. Marshall, who probably would even have a better insight into the larger vessel size patients. But where we hear the most of the adoption is just larger tumors. We're also seeing it in uterine fibroid embolization. Speaker 200:22:08But Doctor. Maraslow, you want to comment further? Speaker 600:22:10Yes. First of all, morning, thanks for letting me participate. So I actually used the TriNev large yesterday. And where we're seeing physicians use it most it's mostly in the liver and it's for tumors that are fed by larger arteries. So the size range for trying that large is an artery that's three to five millimeters in diameter. Speaker 600:22:34That's larger than a standard hepatic artery. So tumors that are really vascular like hepatocellular carcinoma, neuroendocrine tumors and then multifocal where there are multiple tumors in the same vascular bed. And we're seeing great results with it. Physicians are happy with it because they're able to treat a larger area. And as Mary mentioned we are seeing its use in uterine fibroid embolization. Speaker 600:23:02Its larger capacity allows physicians to deliver more drug faster. And so those are the two primary uses. We are seeing increased use in the thyroid where some of those arteries are larger because of larger goiters. And I think that's a good synopsis of how it's being used now. Speaker 500:23:28Great. I appreciate the color there. And then in terms of your clean room expansion, when were those initiatives complete? And how should we think about cadence for the balance of the year in the gross margin line? Speaker 300:23:40Yes, I can take that one, Ross. Thank you. It was completed in March. So it was probably kind of February, March time frame and obviously had a negative impact on gross margin. So now that it's completely done, we're kind of back to full scale progress. Speaker 300:23:56And I think our gross margins should definitely trend back up to kind of where they were previously. So I would expect that number to continue to improve for sure in the second quarter. And then depending on how good the second quarter is, we still may get even better. But I would expect kind of upper 80%. We've hit 90% in the past. Speaker 300:24:19That would be a great quarter, but upper 80s is kind of ballpark we should be playing in from a margin perspective. Does that answer it, Ross? Speaker 500:24:28Yes. Perfect. Thanks for taking our questions. Congrats on progress. Speaker 200:24:32Thank you. Thanks. Operator00:24:34The next question will come from Frank Takkinen with Lake Street Capital Markets. Your line is now open. Speaker 700:24:44Great. Thanks for taking the questions. Congrats on all the progress. I was hoping to start with cadencing of revenue. Obviously, in light of the financing, you're increasing the sales force. Speaker 700:24:53So maybe how does that impact the growth rate as we go through the back half of the year to accelerate to achieve that 50% growth for the full year? Speaker 200:25:02Yeah. So one of the things of the whole private placement was really twofold. The goals were twofold. Number one, we're seeing just incredible momentum. We know that if we could add sales resources, marketing resources, we could potentially even grow even higher than our current growth rate. Speaker 200:25:23And so we plan to add sales resources starting now. We had a number of positions that we were targeting that we wanna fill rapidly. We'll probably layer them in over the next couple months, and you'll see the biggest impact in the fourth quarter, but really the significant impact will be in 2026. Usually it takes about three to six months for reps to really get their footing and get on board and start driving meaningful volume. So you'll see that being peppered in over the second half of this year. Speaker 700:25:59Got it. That's helpful. And then maybe just for the second one, I was hoping you could comment on maybe any feedback you've heard from physicians on the new mapping code. Know when we spoke with physicians, that was one of the key issues that they were speaking to of using the device more frequently in their practices. So maybe what's kind of early feedback, understanding it's only been forty five days since that's been effective, but what's early feedback, and how should we kind of think about the impact of that? Speaker 200:26:25Really favorable. I will tell you that I think, as a company, I'm not sure we fully appreciated that that was holding us back, but we're really starting to see people use this much more predominantly and consistently. So very favorable feedback across the board. So we're very excited about it. I think it now gives us full reimbursement. Speaker 200:26:48And now with our product portfolio, we have a full vessel range size. So it allows physicians to adopt it much more broadly than how they were before. I think it was more selective. Now that we have the full portfolio and a full reimbursement, you know, they're very comfortable now using it in a much broader set of patients. Speaker 500:27:08And if I could add, Speaker 600:27:09I think physicians, they're no longer worrying too much about, you know, can I use this in this setting? It's much more straightforward. They're treating disease based upon the disease and not worrying so much about reimbursement. Speaker 700:27:22Got it. That's helpful. Thanks. Operator00:27:27And our next question will come from Suraj Kalia with Oppenheimer. Your line is open. Speaker 800:27:35Hi, Mary. Can you hear me all right? Speaker 200:27:37Yep. Good. Good to hear your voice. Mary, Speaker 800:27:41congrats on all the progress. Hey, Mary on Neltalimod, I'm curious, One is the drug's PK profile. Right? The 12 patients that y'all have done, how would you characterize the relative balance between the drug's PK profile and the delivery mechanisms, titrations schedule across the patients. Do we know which side that is tilted more? Speaker 800:28:09I guess what I'm really trying to understand is, you know, what leverage would you all have eventually as you all start your discussions with strategic partners? Speaker 200:28:21Yeah, so you know what's interesting? We actually saw this in our metastatic uveal melanoma trial, that melatonin had very long term effects. And that you actually saw late favorable effects, even eight months, ten months out. So we don't know exactly why that is the case, but we've seen that across the board. And we know that this drug and its effects and we're going to have some publications come out soon with hypotheses around the mechanism of action. Speaker 200:29:00But because it's a type C and its effect on myeloid derived suppressor cells, there's a hypothesis that it has a much longer duration of effect on the immune system. So I think that's just our early view of it. This is a phase one trial, so there's still so much to know about that. But I think what's the feedback that I've received from various people that I've spoken to, and probably what was intrigued other parties the most was, particularly in our uveal melanoma, metastatic melanoma trial, was that naletolimod actually helped patients who were checkpoint refractory. So obviously, that's a very big focus for big pharma on, you know, can you make a patient who's not receptive to a checkpoint receptive? Speaker 200:29:49And so I think that was a big focus of their interest in nalotolimod. Does that help? Speaker 800:29:54Yep. Yep. Fair enough. And Mary, as a follow-up, the 42% growth in TriNet, right, it's quite impressive, especially in the current environment. And I'm curious if you could give us some additional color. Speaker 800:30:07You know, the 42%, how broad based, deep, just some additional granularity on utilization characteristics would be great. I know you all said 32 new accounts added, but just kinda give us a broader picture to help us better understand the cadence as we walk through the quarter. Thanks again and Yes. Speaker 200:30:28Typically, we our first quarter is generally our lower first quarter. We usually come off a very strong fourth quarter, which we did. And then we see it build throughout the year. I think one of the things that's been a catalyst for us is also getting the additional code, which we had not planned for actually in our planning for 2025. We've really seen a nice improvement in momentum starting once the code was announced. Speaker 200:30:56But what you'll see is throughout the year, we start to see utilization generally increase significantly. The part of that is due to the big focus change that we had from last year. Last year, we were just trying to get into new accounts. So we had a big focus about getting through back approvals, getting into as many different hospital accounts as possible. This year, we're in a very significant number of hospitals that are high volume. Speaker 200:31:24Our big focus is on driving utilization and generating utilization beyond just one IR, but into multiple IRs across consistent patient populations. So we'll start to see that utilization grow throughout the year. And we've actually built up our plan in pretty ground up way, where we look at each every territory, where the physicians are using it, how that utilization is changing. So we feel very comfortable about our guidance around the 50% growth. Hopefully that helps. Speaker 200:31:56I don't know, Jim, if you wanted to add anything further. Speaker 900:31:59No, I think that covers it. Speaker 300:32:00I think the big focus, you know, last year, like Mary said, was the getting a lot of new accounts through back approval. And now the focus is more, you know, geared towards utilization. So I think she summed up well. Speaker 600:32:12And I also think we have a lot better data that our physicians are using, in particular our healthcare economics outcomes research that demonstrates cost savings with use of TriNet down the road. So I think people appreciate that the device is actually useful from that from an economic standpoint. Speaker 800:32:33Appreciate it. Operator00:32:36The next question will come from William Plowenick with Canaccord. Your line is open. Speaker 900:32:43Great, thanks. Good morning. Couple of questions if I could. Just first, just on the kind of commercial organization on the sales force, what was the number at the end of the quarter? Where do you look to go by the end of the year? Speaker 900:33:02Investing in this? Just trying to get some data behind it. And then on the new on the accounts, you had a big number of new accounts. But what's the net account number as you exited Q1? And then I have a follow-up. Speaker 200:33:17Sure. So we currently have, and we don't split out kind of we have clinical specialists and reps, and we have about 45. And then we have management. Our goal is over the next eighteen months, I'd like to get to about between sixty and seventy. What we've been trying to do, Bill and this is something that we've learned along the way. Speaker 200:33:43We hired probably too aggressively years ago, and we now really understand what the phenotype of the sales representative that we need. And so we've been much more thoughtful about adding that type of rep. They have to have a blend of clinical skills, technical skills, but they also need to know how to build a new therapy. And we have a wide array of different applications. So that's a more targeted type of representative that we're looking for. Speaker 200:34:10So we'll add that over the next eighteen to twenty four months. That's our goal. And we've been very thoughtful about where to place them, where the volume is, and how to balance that among the different applications. And that's going be a big part of it. Does that help? Speaker 900:34:27Yes. And then on the accounts, Jim? Speaker 300:34:29Yeah, I think the accounts, it was in the neighborhood of right around 300 at the end of the year. And we added about 30 or 40 this quarter. So it's kind of the low to mid 300s. Speaker 900:34:45And then on the updated guidance and the push out of profitability, just how much of that is a function of the commercial organization expansion versus the investment in thyroid and some of the other programs? Speaker 100:35:03Yes, it's probably Speaker 200:35:04about 60 expansion of the commercial organization, and then about 40% investment in new applications. We're gonna start a registry test trial in two new applications. One is in genicular artery embolization, which we think is a really promising high growth area for us. We're also going to do a registry in uterine fibroid embolization. And our goal is ultimately across a wide array of different applications, is build this registry data that allows us to refine what are the clear endpoints and differentiation of TriNav in these procedures, collect outcome data, and collect data that ultimately we could submit for inclusion into the guidelines. Speaker 200:35:48And so those registries are not as costly as a significant clinical trial, but it can function like a clinical trial because we can compare to standard of care, although we can bill for therapy as those patients are enrolled. And we'll have multiple different registries by the end of the year. And then our goal in 2026 is to add some additional registries in some of the other areas and new applications that we're exploring right now. Speaker 900:36:17Okay. And then the last question, if I can sneak one in. Just on the second quarter, you're guiding 50% for the year. The Street's sitting at, I think, 10.4% were 10.5 So up a little over a million. Yeah. Speaker 900:36:32Is that something I mean, this everything's back half loaded right now. You know, are you comfortable with the second quarter consensus at this point? Speaker 600:36:42Yes. Thanks for taking my questions. Speaker 200:36:43Yes. Operator00:36:48And our next question will come from Jason Witz with Roth. Your line is now open. Speaker 600:36:56Hi, thanks for taking the questions. Mostly follow ups here. First off, on the sales force expansion, does that get you to basically what you would consider a full penetration in terms of covering the entire country? Speaker 200:37:09No, not yet. There's roughly about 400 hospitals that represent about 80% of the procedural volume. So I would say that over the next eighteen months, that will get us there if we fill all of those reps. But one of the other things that we're considering and we're working through right now is these new applications offer a lot of volume, and so we're going back and looking at our procedural model, and does these new applications and the utilization modify some of those plans? So I don't have a complete answer on that, particularly with thyroid and GAE, and some of these other new procedures which are done in different locations that may modify that a little bit. Speaker 200:37:53So that's why I'm not answering that specifically. We'll have a better plan and understanding of that over the next couple months. Speaker 600:38:00Okay, that's fair. And did you break out sort of between taste and tear, sort of what the trends have been in terms of usage right now? Speaker 200:38:12Maybe I'll have Doctor. Marshall talk about that. You know, we see the data. It's generally been about fifty-fifty, but we know that it's skewing a little bit more towards radio embolization. Doctor. Speaker 200:38:22Marshall, you want to talk about that? Speaker 600:38:24Yep. I can talk about the overall feeling with our new CPT code for mapping. And I think that's really generating a lot of buzz among physicians. And I think as we look at the market as a whole care is trending way higher than take it. The care has become the number one local regional therapy to keep patients on liver transplant list. Speaker 600:38:50And so I think we'll see that continue with the use of TriNav. They'll follow that path. For TACE, we still see very heavy use in things like neuroendocrine tumor embolization. And while that's a small subset of patients these patients get numerous embolizations so one patient might receive four or six treatments over their lifespan. The growth is definitely in tear at the moment. Speaker 600:39:18Got it. Thank you. I'll jump back in queue. Thank you very much. Operator00:39:21I am showing no further questions at this time. I would now like to turn the call back over to Mary for closing remarks. Speaker 200:39:36Okay. Thank you, everyone. I really appreciate you joining the call, and thank you for all your questions. Operator00:39:43This concludes today's conference call. Thank you for participating. You mayRead morePowered by