NeurAxis, Inc.NRXSNYSE
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AI Earnings SummaryQ4 2025
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Earnings Call Transcripts

Q4 2025Earnings Conference Call

Operator: Ladies and gentlemen, thank you for standing by. Welcome to the NeurAxis, Inc. fourth quarter 2025 financial results. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to Ben Shamsian, Investor Relations. Please go ahead.

Ben Shamsian: Thank you. Good morning, everyone, and thank you for joining us for NeurAxis, Inc.’s fourth quarter and full-year 2025 financial results and corporate update conference call. Joining us on the call today is Brian Carrico, CEO of NeurAxis, Inc., and Timothy Robert Henrichs, CFO of NeurAxis, Inc. At the conclusion of today's prepared remarks, we will open the call to questions. If you are listening through the webcast, please follow the operator's instructions, or you can send me an email at nrxx@listenpartners.com with your question. If you are dialed into the live phone line, you can again follow the operator's instructions. Today's event is being recorded and available through the webcast information provided in the press release. Finally, I would like to call your attention to the customary safe harbor disclosures regarding forward-looking information. The conference call today will contain certain forward-looking statements, including statements regarding the goals, strategies, beliefs, expectations, and future potential operating results of NeurAxis, Inc. Although management believes these statements are reasonable based on estimates, assumptions, and projections as of today, these statements are not guarantees of future performance. Time-sensitive information may no longer be accurate at the time of any telephonic or webcast replay. Actual results may differ materially as a result of risks, uncertainties, and other factors, including, but not limited to, the factors set forth by the company's filings with the SEC. NeurAxis, Inc. undertakes no obligation to update or revise any of these forward-looking statements. With that said, I will now turn the call over to Brian Carrico, Chief Executive Officer of NeurAxis, Inc. Brian, please proceed.

Brian Carrico: Good morning, and thank you for attending our fourth quarter and full-year 2025 earnings call. During today's call, I will highlight the continued execution of our commercialization strategy for IV Stem, our neuromodulation technology for both the pediatric and adult patient populations. The continued execution has set the stage for the growth we expect in 2026. Today, we will recap Q4 and quickly turn to the first quarter, which I believe is most important and what everyone is looking to hear. To recap Q4 in a nutshell, we continued our commercial scaling strategy, we picked up 45 million covered lives for our proprietary PNFS technology, and were granted a federal FSS contract with IV Stem as our first listed product to allow our teams to sell within the VA. Following my remarks, Timothy Robert Henrichs, our CFO, will review our financial results for 2025. Let us first talk about the commercial execution of reimbursement progress. As we have mentioned in the past, the years leading up to January 1 focused on achieving two critical milestones: securing a Category I CPT code and obtaining written insurance policy coverage to enable widespread, sustainable growth. Once it became clear that the Category I CPT code would become effective on January 1, 2026, we implemented a more focused commercial strategy, and that strategy remained unchanged through the first quarter. The objective for the first quarter was straightforward: deploy the strategy, gather real-world data, and learn as much as possible about what drives adoption and what gaps remain. With the knowledge gained during Q1 to date, we now have a much clearer and more actionable growth roadmap. For the first time, the story has become significantly easier to understand. With a Category I CPT code in place, more than 100 million covered lives, our focus has shifted from access creation to execution, identifying what remains missing and closing those gaps to unlock maximum growth. Today, I will outline what we have successfully put in place, what we have learned, and where our execution efforts are focused going forward. Overall, I am extremely pleased with the first quarter performance across all fronts, including revenue progressions, stronger-than-expected operational fundamentals, and, importantly, the clarity gained around the remaining drivers of growth, which allow us to now begin deploying a more comprehensive commercial strategy. We will provide detailed KPIs and financial metrics on our next earnings call when we will have a full quarter of operating data. From an adoption standpoint, we are seeing excellent performance from accounts that have a Category I CPT code, strong medical policy coverage, a physician champion, and dedicated IV Stem clinic time each week. Conversely, institutions with only partial or limited policy coverage are submitting fewer patients, as physicians still perceive that a meaningful portion of patients lack reimbursement certainty. In line with our plan and expectations, overall patient submissions have increased significantly following the implementation of the Category I CPT code. While a small number of hospitals with strong policy coverage have not yet reached expected utilization levels, these cases are not representative of broader trends. As anticipated, expansion of our commercial footprint remains essential, and we will now begin to scale these capabilities alongside growing reimbursement access. Importantly, the most important piece of knowledge I set out to understand in Q1 was whether insurance companies without PNFS written policy coverage would cover IV Stem with the Cat I code, or if we would indeed need written policy coverage to see patients covered. We have confirmed that payers do not provide coverage based solely on the CPT code, and therefore, medical policy coverage remains essential. While I will not discuss specific payer negotiations today, we are very confident in our positioning with the remaining key payers. The potential impact is significant, particularly when considering the current submission growth is being driven by only approximately 10% of children's hospitals nationwide. Our strategy, therefore, remains laser-focused on expanding medical policy coverage while simultaneously increasing the commercial footprint. Securing additional payer coverage remains our highest priority. At the same time, our internal prior authorization team continues to expand, helping hospitals reduce administrative burden, improve reimbursement confidence, and ultimately increase patient access—a critical step toward broad national adoption. We continue to make meaningful progress with the nation's largest payers and remain in active dialogue as multiple payers approach scheduled medical policy review cycles through 2026. In late December, we announced policy coverage from a major national health insurer, spanning multiple states and representing about 45 million health plan members. Our advocacy efforts center around the urgent need for pediatric coverage and the clinical risks of the off-label drugs with FDA black box warnings. Based on external expert opinion, we believe we have the most comprehensive payer engagement effort in our industry. Discussions with payers have been constructive, and we are confident this multichannel approach will drive favorable policy consideration. That said, we expect policy changes and prior authorization improvements to unfold gradually, not overnight. I now want to focus on and highlight the catalyst for what we expect to be continued revenue growth in the coming quarters. Two elements remain key to IV Stem's success. First, the insurance coverage for access, which I just discussed in detail. Second, commercial footprint expansion in several areas. Now that we have 100 million covered lives and continue to see positive payer momentum supported by the clinical practice guidelines, commercial readiness for 2026 is paramount. In addition to the insurance element just mentioned, the commercial execution is equally important and the primary focus of our commercial team. As the new CPT code takes effect and coverage becomes more available, it is paramount for children's hospitals to have enough dedicated time slots each week to treat patients in need. Our commercial organization is fully aligned for the 2026 transition. We have prioritized target accounts based on their utilization potential and launched comprehensive education and outreach, including direct engagement with 75 children's hospitals who previously ordered IV Stem, which does not include new accounts in Q1; division chief meetings with detailed RVU and financial modeling, which will become more and more important; comprehensive partnership with NASBIG, beginning with the CME-accredited presentation—we did one in November and will do another one this spring; integrated marketing, which highlights the positive reimbursement shift, which appears as strong or better than we expected; field programs focused on the clinical and economic value of the new CPT code; and we are working closely with all stakeholders to ensure there are dedicated weekly time slots available for patient treatment with IV Stem. These coordinated efforts are cultivating awareness, positioning IV Stem for broad adoption now that the new CPT code has taken effect. Most importantly, these efforts require people, so we are in the process of hiring experienced and successful people on several fronts, including medical science liaisons to ensure our data is well known and top of mind; we are hiring market development specialists to ensure the financial stakeholders understand the positive economics behind the IV Stem procedure; a digital marketing expert focused on ensuring we have a presence in front of all patients and physicians; and salespeople to make sure we are covering all aspects. We will hire each position and duplicate those positions that are most successful in the areas where we have the most opportunity. This brings me to our commercial strategy for IV Stem in adults. As many of you know, the Category I code for IV Stem applies equally to adult patients, as it reflects the same physician work using the same device technology. What may be less widely understood, however, is that while IV Stem has FDA clearance for adult use, that clearance was based on extrapolation from adolescent clinical data rather than a large standalone adult randomized study. With that said, it is important to note that several studies using our technology have included young adults in their twenties. And, importantly, the underlying pathophysiology of these conditions is not meaningfully different between adolescents and adults. The FDA recognized this overlap, along with the alignment across Rome diagnostic criteria and the device's favorable safety profile, in supporting broader use. Nonetheless, broad medical policy coverage for adults is not expected in the near term. Based on what we learned during the first quarter, we believe payer coverage in the adult population will likely require completion of a large randomized controlled trial. Importantly, this does not change our execution priorities. Our primary commercial focus will remain within the children's hospitals, where coverage expansion continues to accelerate, as well as within the Veterans Administration system. That said, we are pursuing the adult IV Stem opportunity through two parallel strategic pathways. First, we have executed an agreement with the Cleveland Clinic to conduct a randomized controlled trial evaluating IV Stem specifically in adult patients with functional dyspepsia. This study is designed to generate the clinical evidence required to support future medical policy coverage. Second, as previously highlighted as one of our key fourth quarter milestones, we were awarded a Federal Supply Schedule, or FSS, contract enabling commercial access to the U.S. Department of Veterans Affairs. The VA health care system serves nearly 7 million active patients annually, with functional dyspepsia estimated to affect approximately 3% of this population. Given the typical adoption timelines within the VA, I did not expect Q1 orders. However, we are already seeing multiple facilities placing orders, with a growing number moving through the process. We are actively dedicating commercial resources to this channel to expand our sales footprint as utilization data and clinical adoption continue to develop.

Stepping back, the most important point is this: the fundamental barriers that historically limited adoption are now being systematically removed. With the Category I code in place, expanding medical policy coverage, accelerating patient utilization, and a scalable commercial infrastructure now operational, we believe IV Stem has entered the early stages of its true commercialization phase. Execution is now the primary driver of growth. As coverage expands and utilization continues to scale across hospitals, payers, and federal health care systems, we believe the gap between clinical demand and current adoption will continue to close. Our focus remains disciplined, data-driven, and centered on building long-term sustainable value.

To summarize what we learned in Q1 to date: children's hospitals that have strong insurance policy coverage, at least one physician champion, and adequate IV Stem clinic time are performing extremely well. The void of any one of these three is a barrier to making sure every child has access. Written insurance coverage is essential to patients being treated through insurance. We learned which gaps need addressed as clinical reinforcement to ensure all physicians are aware of the data, along with keeping IV Stem top of mind. We learned communication is key to understand which barriers or perceived barriers still exist. We learned the economics are very strong for the PNFS procedure in children's hospitals. Delivery of this information to the administrators and financial stakeholders in the children's hospitals will be a strong focus of our team going forward. And finally, revenue has been surprisingly better than I expected in Q1. It has also been heavier at the top than I expected, but that is great in the fact that we now know what a children's hospital with all pieces in place can do, and that is outstanding for our future. Make no mistake. We have work to do and gaps to fill, but the hurdles we face today are nowhere near the hurdles we have overcome to be in this situation. We have never been better positioned operationally, commercially, or strategically than we are today, and we believe the progress underway in 2026 represents the beginning of a multiyear growth cycle for the company. I will now turn the call over to our CFO, Timothy Robert Henrichs, to discuss the financials.

Timothy Robert Henrichs: Thank you, Brian. And let me add my welcome to everyone joining us on this call. These financial results were included within our press release, which was issued earlier this morning, and were also provided in more detail within our 10-K. I will provide some additional details in key areas such as our financial results and liquidity position, as well as an outlook on certain areas. The 2025 marked the sixth straight quarter of double-digit revenue growth year over year. 2025 was a year of significant milestones for the company, including FDA indication expansion to functional abdominal pain and functional dyspepsia with associated nausea symptoms in both children and adults; IV Stem label expansion from 11–18 years of age to eight and up, including an increase of devices per patient for a course of treatment to four; the published NASPA and academic society guidelines; the new Category I CPT code and RVUs; the introduction of the RED device; an FSS contract; and, last but not least, medical policy coverage representing approximately 45 million health plan members from a major national health insurer in December. The accomplishments position the company extremely well as we continue to grow revenue with stronger gross margins and operating expense leverage. With that, I will go through the financial highlights in detail. Revenues in Q4 2025 were $968,000, up 27% compared to $761,000 in Q4 2024. Unit deliveries increased 35% compared to the prior year, due to volume growth from patients with full reimbursement health insurance; a market shift from our historical mix of the company's discounted financial assistance program outpacing the growth of higher-margin full reimbursement patients. In fact, 2025 marked the seventh straight quarter of double-digit unit growth. Although our average selling price in Q4 2025 was lower than in 2024, it reached its highest level in 2025, thanks to the mix shift to our more profitable reimbursement channel. As previously mentioned, we picked up our largest insurance payer in Q4, who gave immediate effect of full reimbursement that helped drive the mix shift. Given the Category I CPT code that went effective on January 1, we expect the positive mix shift impact on revenue will continue into the first quarter. Revenues in fiscal year 2025 were $3.6 million, an increase of 33% compared to $2.7 million in fiscal year 2024. Unit deliveries increased 44% due to both patients with full reimbursement health insurance coverage and those participating in our discounted financial assistance program, with the latter slightly outpacing on the growth front for the full year. Gross margin in Q4 2025 was 85.4% compared to 86.4% in Q4 2024. Despite the meaningful mix shift from discounted financial assistance to full reimbursement coverage in the quarter, the primary drivers for the 100-basis-point decrease are reserves established for excess and obsolescence inventory and the growth of the RED device in the quarter, which has a substantially lower gross margin than IV Stem. Gross margin in fiscal year 2025 was 84.2% compared to 86.5% in fiscal year 2024. Despite our increase in revenue, the 230-basis-point gross margin decline was due to higher discounting and growth in our financial assistance programs in particular during the first three quarters, and then excess and obsolete charges on inventory related to our RED device. Despite the decline in our gross margin in the fourth quarter, we expect to reverse that trend in 2026 as the new Category I CPT code became effective on January 1, which will transition currently discounted device sales to full reimbursement revenue with insurance coverage. Total operating expenses in Q4 2025 were $2.5 million, an increase of 20% compared to $2.1 million in Q4 2024. We measure and manage our operating expenses along three functions: selling, research and development, and general and administrative. As we continue to grow at a double-digit pace, we realize that investors will benefit from a more transparent presentation of our selling and research and development costs, as those are indicators of our future success. As a result, we reclassified $297,000 and $57,000 from general and administrative expenses into selling expenses and research and development costs, respectively, in Q4 2024 to conform to the current period presentation. Selling expenses in Q4 2025 were $518,000, a 31% increase compared to $396,000 in Q4 2024. The increase is due to sales commissions that are directly related to our higher sales volume, a temporary commission structure to facilitate growth and adoption in new states, and higher targeted marketing costs as we prepared for IV Stem's Category I CPT code that became effective on January 1. Research and development expenses in Q4 2025 were $137,000, an increase of 15% compared to $120,000 in Q4 2024. The increase is reflective of higher year-over-year spending on a medical research project. General and administrative expenses of $1.9 million in Q4 2025 were 17% higher than the $1.6 million in Q4 2024. The increase was due to the introduction of a long-term incentive plan in 2025 that did not exist in 2024, and third-party costs incurred to enhance the company's systems and internal control environment, partially offset by the absence of certain one-time, nonrecurring consulting and advisory costs incurred in 2024. Total operating expenses in fiscal year 2025 were $10.8 million, an increase of 14% compared to $9.5 million in 2024. As a note, similar to my comments earlier on the fourth quarter, we reclassified $1.1 million and $228,000 from general and administrative expenses into selling, and research and development costs, respectively, for the full fiscal year 2024 to conform to the current period presentation. The increase in operating expenses year over year was due to higher selling expenses from commissions, headcount, and marketing costs focused on health insurance carriers, and a one-time nonrecurring legal settlement. Our operating loss in Q4 2025 of $1.7 million was 17% higher compared to a $1.5 million loss in Q4 2024, and our net loss in Q4 2025 was $1.7 million, 18% higher compared to $1.4 million in Q4 2024. Our higher gross profit from increased quarterly sales year over year was offset by the higher operating expenses that I just discussed. Our operating loss in fiscal year 2025 of $7.8 million was 9% higher compared to a $7.2 million loss in fiscal year 2024. Our higher gross profit from increased sales year over year was offset by the higher operating expenses. Our net loss in fiscal year 2025 of $7.8 million was 5% lower compared to $8.2 million in fiscal year 2024, primarily due to higher sales and the absence of one-time nonrecurring settlements related to a convertible note dispute and certain pre-IPO Series A preferred stock shareholder claims incurred in 2024, partially offset by higher operating expenses. Cash on hand as of 12/31/2025 was $5 million. Our free cash flow in Q4 2025 was $2.5 million, higher than our core quarterly burn rate of $1.5 million, due to higher marketing expenses as we successfully focused on health care insurers for additional coverage and an inventory build to prepare for the increased demand in Q1 2026 related to the January 1 effective date of IV Stem’s Category I CPT code. Since then, we have improved our current liquidity position here in 2026 by raising an incremental $2.6 million through our at-the-market equity facility and the exercise of warrants. Our current cash balance is over $6 million. Given our current Q1 burn rate, our balance sheet provides us with sufficient capital to execute on our growth plans, with no near-term need for additional financing at this time. We still have approximately $1.2 million remaining in our existing ATM facility, which, if utilized strategically for further growth, would extend our liquidity position further, along with future warrant exercises. With that, I will turn the call back over to Brian.

Brian Carrico: Thanks, Tim. To summarize, we are very happy with the way Q1 is coming along. I would just say that revenue, as I said, is better than I expected. Most importantly, we have learned what gaps need to be filled, and we can finally be able to turn this into the commercial strategy and hire the people to have the comprehensive footprint that we need. I will now turn this back to the operator, and I look forward to questions.

Operator: Thank you. As a reminder, to ask a question, please press star 11, and to withdraw your question, please press star 11 again. The first question will come from Chase Richard Knickerbocker with Craig-Hallum. Your line is open.

Chase Richard Knickerbocker: Good morning. Thanks for taking the questions, and congrats on all the progress here. Lots of things to go through, but maybe first, Brian, in Q1, can you give us a sense for the magnitude of inflection in PA requests and any improvement in PA rates since that Level I code? And then, last on that front, with that large payer win in Q4, can you confirm under that coverage policy that there is not a PA that is being required in the market right now? Thanks.

Brian Carrico: Yes, Chase, good to talk to you. Two good questions. Let us first talk about the prior authorization. We do—and this number will change—but in the first quarter, if we did $100 in revenue in Q1, $20 is revenue that comes from accounts that we do the prior authorizations for. So I can only speak for what we see. We are continuing to do prior authorizations for more and more children's hospitals. The submission rate is up close to 10x from what we saw in 2025. That is first, which is outstanding. That does not mean the approval rate is that high. On the Q1 call, I will give more specifics about the exact numbers that we see, and I will also talk about approval percentage that we see. For example, if last year 1% of submissions were approved, and this year it is 2%—now those are just made-up numbers, and they are not even close to accurate—but I will give more information on the approval rate and percentage to give everybody a general idea along with some examples on the Q1 call. Regarding the large payer, that is correct. There is no prior authorization required from the large payer as long as they have the correct diagnosis codes in place. That has been very beneficial. I will go ahead and get ahead of one of these questions coming with that payer. Yes, of course we are seeing a direct effect from a revenue standpoint in certain areas where that payer has significant presence. But at the same time, we have countless children's hospitals that—let us just say their hospital has 20% or 25% of their patients with that payer. That sounds wonderful, but when the other 75% of their patients are not covered, they are still essentially not treating. Maybe one or two of their physicians are, but as a group, they are not treating because they still view this as a health equity issue. If the majority of their patients cannot have access to it, they are not giving access to even that small group. With bigger payers and additional larger payers coming on board, you will not just get the benefit of that new large payer. You will get the benefit of the payers we have plus the new one because they want to see that 50%, 60%, 70% of their patients are covered before they start to offer this across the board with all physicians from a referring standpoint. There are other small barriers that will just take time, and I can give more examples of those around IV Stem clinic time as we get further into the questions. Chase, I hope that answers your question. If not, I will go into more detail.

Chase Richard Knickerbocker: No, good color. Maybe along those lines, on the number of accounts since January 1 with all these developments aligning, can you give us a sense for the number of new accounts? And then on your highest adopters—I think some of those have a fair amount of exposure to that payer you won at the end of the year—can you give us a sense for utilization trends there, if you have seen a meaningful inflection in Q1? It certainly sounds like you have, but maybe just some color there.

Brian Carrico: Yes, it has been top heavy. I would just say that I have been pleasantly surprised with the children's hospitals that have access to and are heavy with that payer, and had IV Stem clinic time already built in. Those that can adapt to that and have physician champions are doing extremely well. But as I mentioned on the call, if they only have that one payer or they do not have the IV Stem clinic time put in place, I will give you an example. One of the states that is 80% that payer has submitted to us—just call it 20 patients in the first eight weeks of the year. You would think that 75%–80% of those patients would be from that payer, and it is not the case. Only 25% were. So let us use numbers of five out of 20. Of those patients, five were from that payer. The other 15 were other payers from around the country or other payers we do not have policy with. Although only 25% of their patients are with that payer, they are already booking IV Stems out to September. Now they are fixing that. They are adding more IV Stem clinic time. But when I spoke to the account last week, the director said, “We have to put together a plan. We have to present those to a committee, and that has to go to another committee. This is going to take until May or June.” The point is the good news is they are treating a tremendous amount of patients even though it is only 20% or 25% of their patients that are being approved. It takes time. These children's hospitals take time. The good news is that excellent financial story, which I referenced, and now that we have learned much more about the payments in the last four or five weeks, that becomes a much bigger piece of this story because it allows the children's hospitals to— they are not going to lose money, and in fact, they should be, as a general rule, in a very good financial position with the more patients they treat. So this is a win for the patient, a win for the facility. We need more policy coverage. But it is a long-winded way of saying that children’s hospitals that are heavy with the payer that we had—and look, we have got another 55 million covered lives—and we have seen great growth in some of those accounts where we already had that policy coverage, but the Category I code was missing, and now we are seeing a significant uptick in prior auth submissions. I think the overall message here is that as happy as we are with the accounts that are treating, there are still many treating no one, and that is outstanding news for the big picture. We feel very confident in our position with the larger payers, and that is all I am going to say. I knew for several months before we got the large payer in December that it appeared we were going to get that, and I did not say anything, and I am not going to say anything now about other payers and the position we are in. We feel like this should be the first-line treatment or a first-line option for these kids based on the evidence, and that is our stance. Again, a long-winded way of saying we are very pleased fundamentally when the pieces are in place, and when something is missing, at least now we know what is missing and how to address that, and we are doing so aggressively.

Chase Richard Knickerbocker: Got it. I know you are not giving 2026 guidance at this time. I wanted to get some initial thoughts, if you have them. I understand it is very dynamic. Maybe the best way for me to ask it is: as we sit here in Q1—you had about a 20% sequential inflection from Q3 to Q4—with all this commentary, I would expect that materially accelerates. Any goalposts that you could give us for the revenue inflection that you are seeing thus far through Q1?

Brian Carrico: No. I think I may have mentioned in Q4 that I thought Q1 had the potential to be light or in line with Q4 just because of the delay in prior authorizations in January and because of IV Stem clinic time getting set up, like the example I just gave. I am only going to say that I am pleasantly surprised. We have five or six weeks until the next call. I will just wait and give detailed KPIs. We are going to give some nice KPIs going forward that are relevant to growth and show the opportunity, and I am going to wait until then to do so.

Chase Richard Knickerbocker: Great. Tim, just last one. Right way to think about SG&A growth in 2026 as you are expanding your commercial capabilities?

Timothy Robert Henrichs: Yes. When we move into 2026, when you look at our three buckets, we have one large payer. It is not if, but when we get another large payer, we will then invest back into our selling expenses and our commercial team.

Brian Carrico: But I—

Timothy Robert Henrichs: I do not think that rate would be much different than the rate that we are seeing at our current pace. I do believe our R&D expenses will tick up because we are continuing to enhance the device here in 2026. From a G&A perspective, year over year, remember in 2025, we had a one-time nonrecurring legal settlement. The charge was about $630,000, so that will be a tailwind. That in and of itself would put us ahead of next year, but we have been really focusing on G&A expenses and either taking them down or keeping them flat so that we have the runway to invest in R&D and in selling expenses. I expect increases in selling. I expect increases in R&D. I am not expecting much of an increase per se in G&A, but that can all change for all the right reasons as we pick up additional health insurance coverage and need to invest in the business. I do believe we are going to get operating expense leverage. To your question, Chase, we are not going to add operating expenses anywhere near the pace that revenue is going to grow, and that is going to help us from a cash flow perspective as well.

Chase Richard Knickerbocker: Great. Thanks, guys. Congrats again.

Operator: Thank you. The next question is going to come from Lindsay Leeds with MicroCap Opportunities. Your line is open.

Lindsay Leeds: Thank you, and congratulations on a strong Q4. I wanted to ask about the hospital rollouts. You were talking about a hospital that was scheduling all the way into September. What can you say about what kind of staff the hospital needs to schedule these, and what are the barriers to getting that program rolling?

Brian Carrico: Well, those are two very separate questions. First, what staff is required depends on the size of the children's hospital, how many physicians are treating, and how many physicians are referring. We have children's hospitals with champions where there might be 25 or 50 physicians, and there are only one or two specific physicians that are treating IV Stem, and only their patients are treating IV Stem. This goes back to needing more and more IV Stem clinic time so that everyone can refer their patients, and we are working through that. The staff that is needed—you need a nurse practitioner or a physician's assistant or a physician to place the device. So that is important. From a barrier standpoint—and let me back up, Lindsay—if you have two new patients per week every week, then because there are four devices per week, that means you need two new patients per week. After four weeks, you have eight placements, and they continue to roll over. You would need, say, a Tuesday morning from 8:00 to 12:00. You need eight 30-minute slots. You would need to staff that, and this is where the economics come into play. That is our job to make sure that is clear as we meet with these children's hospitals. From a barrier standpoint, I mentioned an example a second ago of a children's hospital where they have known since February they were already booking out March, April, May; now they are into September. Now that they get to these committees, that should come back, and they should have plenty of time beginning in, let us call it, May or June at the latest. But then I expect they will need to expand again. When I look through Q1, we have some outstanding results, but I would argue that only one children's hospital is treating at capacity. Even that hospital—there are three or four or five large payers that they do not have, which means they are not even treating those patients. So no one is at capacity. When you talk about who is treating as many patients—every patient that they see that truly needs this—I would argue that only one children's hospital is doing so. That is very good news. This is very new. Having everything that they need in place is very new, and they still do not have all the payer coverage that they need. The barriers can be many, Lindsay. You are talking about the department. You are talking about the physicians and who is treating and who is referring. You are talking about the chief of the division. You are talking about the chair of pediatrics, the chief revenue officer, the VP of finance, the CFO. Depending on the size of the hospital, there could be many barriers, many committees that prevent this or slow this down regardless of the clinical need and the clinical demand. We are working through that. The good news is, at least at the top, there is no resistance there. It is a matter of process and time. This is where, now that we have the information—I have been very clear in the past about measuring twice and cutting once when it comes to spending money. Making sure you have a revenue source is important, and at least understanding the people that you need to put in place before you just go hire. The great news from Q1 is that it has been very clear to us, and we are aggressively hiring to fill these positions to be able to grow and make sure that we are covering 50, 75, 100, 125 children's hospitals. We will do that, and it is going to be a process. But fundamentally, it is better than expected in the places where we have the pieces in place.

Lindsay Leeds: Okay. Thank you. Are you able to talk about your Veterans Affairs program? Will you be hiring additional staff in Q2, or do you know how long it will take you to know the trajectory of that rollout?

Brian Carrico: Well, a few things about the VA. The response and the reception of this technology and the data behind the technology has been stronger than I expected—better than we expected. As I said on the call, I did not expect orders in Q1. The VAs, by nature, move a little slower, but we have seen several facilities order, and we are seeing reorders, which is excellent. As I see more facilities order and more reorders, we will be a little quicker to hire more people, and we are looking at a bigger-picture commercial rollout where we are considering making the reps that are covering the VA also cover children's hospitals. You start to have a national sales force and national payer landscape. It does not make sense to have—I am in Indiana, so I will use that as an example—it does not make sense to have someone in Indiana calling on the VAs and someone else in Indiana calling on the children's hospitals. We need to be able to scale the commercial operation. As we continue to transition throughout 2026, we will move towards that model. One thing that sticks out to me is there was an article I read two weeks ago about the VA: the FSS contract is just a license to go to the VA and be able to move the technology. I would argue that anytime you have an FDA indication, it is just a license to be able to go to the hospital and sell. This is really no different. Are there some barriers in the VA from a resource standpoint? Of course. There are resource barriers in children's hospitals. There are resource barriers everywhere. This has been no different, but I am pleasantly surprised with the uptick in response and positive feedback and initial adoption in the VA. So yes, as we move into Q2, I expect there will be additional hires. I expect by 2027 that we are beginning to marry the children's hospitals and the VA from a commercial standpoint. We will talk more about that as we get closer. Make no mistake. We have been very lean, and that is because we needed a revenue source in the Category I CPT code and an FSS contract. As lean and calculated as we have been, we are going to be measured and calculated going forward, but we are going to be very aggressive from a commercial standpoint.

Lindsay Leeds: Excellent. Do you have any adult data at all that you are able to take with you to the Veterans Affairs hospitals to promote this IV Stem treatment, or are you basing that mainly on the pediatric data?

Brian Carrico: There is no large randomized controlled trial yet. But there is absolutely adult data. First off, the fMRI data that was done at the Atlanta VA was done at the Atlanta VA, showing cognitive changes in patients using the technology. Many of our studies have patients in their twenties. From a pathophysiology difference, there should be no difference between a 21-year-old and a 45-year-old. The physicians have understood this, and we have gotten very little pushback on the fact that there is no large randomized controlled trial in adults. As I mentioned, we have begun that trial at the Cleveland Clinic in adults, and we expect that to be very meaningful. We are also expecting a publication in a study with patients up to 35 years of age in the coming months from an institution. On the surface, that might appear as a barrier, but it has not been a barrier to date, and I do not expect it to be a large barrier if you understand the science.

Lindsay Leeds: Okay. Perfect. Thank you so much. That is all my questions.

Operator: The next question comes from Karen Sterling with Kingswood Capital Partners. Your line is open.

Karen Sterling: Thank you. Good morning. Hi, Brian. I would like to pick up where Lindsay left off on the IV Stem trial in adults. Could you give us a little bit more detail on how that trial is laid out and what your expectations are? How do you expect it to benefit the company going forward?

Brian Carrico: I expect a large randomized controlled trial at the Cleveland Clinic with a sham arm, in addition to all the data we already have from a mechanistic standpoint. As I mentioned, the other study that is going to be published soon in patients up to 35 should be strong enough to convince the academic society, who in turn can request coverage from payers. I expect this to help gain us insurance policy coverage on the adult side. One thing I have not talked about is the amount of inquiries and requests from adult gastroenterologists to utilize IV Stem. The reality is it would be on a cash basis. There is no patient assistance program due to federal guidelines on the adult side now that there is a Category I CPT code. This is a cash pay, and there is no insurance coverage on the adult side. This is extremely important to us. It is why we are doing such a large study. From a medical device standpoint—look, this is not a pharmaceutical. It is not a drug. It does not have the same risk and side effects, of course, which is one of the many reasons that a pharmaceutical trial is so large. But for a medical device, from a power calculation standpoint, this will be a really strong study at the Cleveland Clinic, and that is the goal of the study. It may take, let us call it, 18 months to do this study. We will know more in the next 90 days about how many patients are being enrolled, and we will be able to have a closer idea and prediction as to when this study will be completed. Then, because we have the data and we already have the indication, we will be able to go directly to the insurance companies. Karen, that is the ultimate goal. This is an extremely large market opportunity. As we talked about earlier, this was the first FDA indicated, approved, or cleared treatment specifically for functional dyspepsia in adults. Right now, the focus is on the VAs, where there is an FSS contract, and we can help people. In the interim, the focus is on this study and ensuring that it is done as quickly and efficiently as possible.

Karen Sterling: Got it. Okay. Apart from the approved indications in dyspepsia and IBS, do you have any plans for opening up additional expansion markets?

Brian Carrico: Now are you talking about additional countries, or are you talking about additional indications?

Karen Sterling: Additional indications.

Brian Carrico: We have a few studies in place. We have the randomized controlled trial for cyclic vomiting syndrome, which would also be in children's hospitals—the same call point, pediatric gastroenterology. We have a couple of other studies that are underway. I would point to the cyclic vomiting syndrome study as potentially the most meaningful.

Karen Sterling: Okay. Can you give us a timeline on that?

Brian Carrico: That is probably also 18 months out, similar to the adult RCT.

Karen Sterling: Okay. Perfect. Thank you. And—

Brian Carrico: And it is on clinicaltrials.gov. There is another study in post-op pain at UPMC. It is about a 300-patient RCT showing opioid reduction or lack of opioid use—eliminating the use of opioids in open bowel surgery. That should be done this spring. There is a lot to discuss about that before I am going to discuss it publicly. Our focus is on the children's hospital. The opportunity there is incredible, and that is where our focus is.

Karen Sterling: Thanks very much.

Operator: Thank you. I am showing no further questions in the queue at this time. I would now like to turn the call back over to Brian for closing.

Brian Carrico: Thank you. Thank you all very much for being with us today. I look forward to communicating with everyone again soon. If there are follow-up meetings or follow-up calls or additional questions, as most of you know, I look forward to those and am happy to meet. With that, have a great day. We will talk soon. Thank you.

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