3/19/2026

speaker
Operator
Conference Operator

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

speaker
Ben Shemzian
Investor Relations, NeurAxis

Thank you. Good morning, everyone, and thank you for joining us for Neuraxis' 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, and Tim Hendricks, CFO of Neuraxis. 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 at listenpartners.com with your question. If you are dialed into the live phone, you can, again, follow the operator's instructions. Today's event is being recorded and available through replay through the webcast information provided in the press release. Finally, I'd 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. Although management believes these statements are reasonable based on estimates, assumptions, and projections as of today, these statements are not guaranteed 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 in the SEC. NARACIS undertakes no obligation to update or revise any of these forward-looking statements. With that said, now I would like to turn the call over to Brian Carrico, Chief Executive Officer of NeurAxis. Brian, please proceed.

speaker
Brian Carrico
Chief Executive Officer (CEO), NeurAxis

Thank you, Ben. 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 Stems. 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 PENFS technology and were granted a federal FSS contract with the IB STEM as our first listed product to allow our teams to sell within the VA. Following my remarks, Tim Hendricks, our CFO, will review our financial results for the fourth quarter of 2025. Let's first talk about the commercial execution of reimbursement progress. As we have mentioned in the past, the years leading up to January 1st of this year, we're focused on achieving two critical milestones, securing a Category 1 CPT code and obtaining written insurance policy coverage to enable widespread sustainable growth. Once it became clear that the Category 1 CPT code would become effective on January 1st, 2020-26, 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 1 CPT code in place and 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'm extremely pleased with the first quarter performance across all fronts, including revenue progression, 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 1 CPT code, strong medical policy coverage, a physician champion, and a dedicated IB 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 1 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 PENFS written policy coverage would cover IV stem with the Cat 1 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, written 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 players, key payers. The potential impact is significant, particularly when considering that 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 insurers and remain in active dialogue as multiple payers approach scheduled medical policy review cycles through the first half of 2026. In late December, we announced policy coverage from a major national health insurer spanning multiple states and represented 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're confident this multi-channel approach will drive favorable policy consideration. That said, we expect policy changes and prior authorization to prove us 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 IB 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. 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've 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 stim, 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 NASP, again, beginning with a CME-credited presentation. We did one in November. We'll 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're 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 and 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're hiring market development specialists to ensure the financial stakeholders understand the positive economics in the IB 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 which are most successful in the areas where we have the most opportunities. This brings me to our commercial strategy for IV STEM in adults. As many of you know, the category one code for IV STEM applies equally to adult patients as it reflects the same physician work performed 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 20s. 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 in 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 IB 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 stems 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 Veteran Affairs. The VA healthcare 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 and expect 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 one code in place, expanding medical policy coverage, accelerating patient utilization, and a scalable commercial infrastructure now operational We believe IB 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 healthcare 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 to date, children's hospitals who have strong insurance policy coverage, at least one physician champion, and adequate IB 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 policy coverage is essential to patients being treated through insurance. Number three, We learned which gaps need addressed such as clinical reinforcement to ensure all physicians are aware of the data along with keeping IV stem top of mind. Number four, we learned communication is key to understand which barriers or perceived barriers still exist. Number five, we learned the economics are very strong for the PENFS procedure in Children's Hospital. Delivery of this information to the administrators and financial stakeholders and 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 multi-year growth cycle for the company. I will now turn the call over to our CFO, Tim Hendricks, to discuss the financials.

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