Neuraxis, Inc.

Good day, and thank you for standing by. Welcome to the NeurAxis 4th Quarter 2024 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question-and-answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. You'll then hear an automated message advising your hand is rate.

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Good morning, everyone, for joining us for Neuraxis's fourth quarter 2024 financial results and corporate update conference call. Joining us today on the call is Brian Carrico, CEO of Neuraxis, and Tim Hendricks, CFO of Neuraxis. At the conclusion of today's prepared remarks, we'll open the call to questions. If you are listening through the webcast, you can send in a question through the portal utilizing the Ask a Question button or simply emailing questions to nrxs at listenpartners.com. If you are dialed into the live call and would like to ask a question, you can follow the instructions provided by the operator. Today's event is being recorded and will be available for replay through the webcast information provided in the press release. Finally, I'd also 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 further 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 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 in the company's filings with the SEC. NARACIS undertakes no obligation to update or revise any of these forward-looking statements. With that said, I would like to turn the event over to Brian Carrico, Chief Executive Officer of NeurAxis. Brian, please proceed.

Thank you, Ben. Good morning, and thank you for attending the fourth quarter 2024 earnings call. During today's call, I will highlight the continuing accomplishments in our commercialization strategies for IV STEM, our IBS neuromodulation technology, and RED, our product for patients with evacuation disorders. We will recap 2024 and discuss the milestones and growth plans for 2025 as we come off another strong quarter of execution and growth. We continue the commercialization of our market leading PENFS technology and is closer to the ability to mass scale nationally. Following my remarks, Tim Hendricks, our CFO, will review our financial results for the fourth quarter of 2024. Let's first review the recent achievements. As I just mentioned, we are coming off another strong quarter of growth year over year, continuing the increase in covered lives and receiving a new FDA indication. This is in addition to the milestones we mentioned on our last call, which were the Category 1 CPT code, which will become effective January 1st of 2026, and the IB STEM age expansion from 11 to 18 years of age to 8 to 21 years of age, nearly doubling our market opportunities. I will speak about these announcements in more detail later in the call. We are continuing to execute on our growth objectives rooted in the foundation that strong published data will drive insurance expansion leading to sustainable revenues and margins. We laid out these objectives in previous calls and continue to put the final pieces in place to allow blanket insurance coverage and in turn the scaling of PE and FS revenues. In recent months, we've made significant achievements as we advanced and hit milestones with the goal of cash flow break-even and profitability. Regarding IB STEM, we are primarily focused on revenue trajectory, and we had significant growth of 40% in Q3 and 43% growth in Q4. We also saw the very beginning of new insurance policy coverage taking effect. As such, I am excited to share with you that the strong momentum of Q3 and Q4 has continued into Q1. I now want to focus on and highlight the catalyst for what we expect to be significant revenue growth in the coming quarters. In the perfect world that we have been working toward and are getting very close to, children's hospitals could access blanket insurance policy coverage for their patients and utilize a Category 1 permanent CPT code. For mass scaling and exponential growth, the patient needs to be covered by insurance, and simultaneously, for that perfect world, the physician needs to be compensated for their time in the form of RVUs or relative value units, which happens with a Category 1 CPT code. We continue to move closer to this full picture being in place. As mentioned earlier, the Category CPT code has been awarded by the American Medical Association CPT panel and will become effective this coming January 1st. Regarding blanket insurance policy coverage, we went from 4 million covered lives on January 1st of last year to approximately 51 million covered lives today. So what does it take to earn the remaining payers? As we've discussed, and as we now know, the scientific community and physicians have accepted our flagship technology, but have been hindered by a lack of written insurance policy coverage on a national level. The most important recognition any medical technology can receive is independent guidelines by the academic society because this is an independent review of the literature and a grade is assigned, which the payers generally accept as the standard. We announced on the Q3 call of 2024 that a systematic review by the academic society NASPGAN, which is the Pediatric Gastroenterology Academic Society, was released at a conference in May 2024 showing the PENFS or IB STEM technology has the highest grade certainty level and largest magnitude effect. NASFGAN, as I just mentioned, is the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, and they are the academic society for pediatric gastroenterology where our technology resides. This systematic review is an abstract form now, but we believe this information is the work being used to publish guidelines any week now. We are told by the largest payers that this publication is an internal mandate for policy coverage, so we are eagerly waiting for this publication to get it to the payers. Sticking with insurance policy coverage, I want to go into detail about the most important aspect of our growth. As we have stated consistently, policy coverage is key to exponential revenue growth. Again, we have had this indication long enough that the academic society and the physicians within the society who treat these patients at the 260 children's hospitals have been aware and are supportive that the insurance policy coverage and Category 1 CPT code are imperative for seamless treatment. We also stated that once the insurance policy coverage is written and in place, the children's hospitals that were not already utilizing IV STEM often take up to 120 days to get the technology loaded, their processes in place, and begin ordering. With all that said, I'm happy to announce we have additional payers, as I mentioned earlier, bringing our total covered lives to about $51 million. Additionally, and as expected, we have countless payers still in the review process. Regarding the children's hospitals, many have been ordering for years, but for a variety of reasons, we have not received insurance policy coverage and those geographic regions. Once insurance policy coverage is written in these areas, the children's hospitals are expected to increase revenue very quickly because the product is already in their system, therefore not needing the 120 days to set up. Turning data into insurance policy coverage and then into revenue is a process that we believe is beginning to work well, and the expected academic society guidelines will only expedite that process. The second part of the seamless treatment for patients, along with the coverage, is the Category 1 CPT code. On the last call, I mentioned we have achieved the company's most important milestone to date in the form of the Category 1 CPT code, which will allow for more seamless billing and reimbursement. This is a permanent billing code that will become effective on January 1, 2026. The reason this code is so critical is that it brings a permanent code, making it much easier for revenue cycle teams to build a procedure It will bring a permanent reimbursement amount, and it will provide RVUs, which is how most physicians' productivity is measured. One could argue that physicians in the children's hospital are currently treating patients for free because there is no RVU, and this will no longer be the case on January 1st. Let's switch to talk about some FDA milestones. Moving to FDA expansions, we have expanded our IV stem label to include a patient population beyond the current 11 to 18 years of age to 8 to 21 years of age, as I mentioned earlier, significantly increasing the number of children we can treat. Regarding RED or the rectal expulsion device, our point-of-care device identifies patients with pelvic floor dysfunction and provides immediate actual test results in patients with chronic constipation. We submitted a 510K in early August, and we received FDA clearance on that technology on December 6th. As we look into 2025, we have submitted to the FDA for an expanded FDA indication for functional dyspepsia in children 8 to 21 years of age. This is critical because it would double our total addressable market, and the synergies within are the same providers treating functional dyspepsia patients. Both IBS and functional dyspepsia fall under the same umbrella of functional abdominal pain disorders, which creates synergy for all aspects of our business, including the sales force. Now I'd like to focus on how our efforts translate to revenue growth and why we continue to be bullish on significant revenue growth as we move closer to national insurance coverage and the effective date for the Category 1 CPT code. We're beginning to see many of the achievements reflected in the numbers. The number of treated cases has increased to over 1,000, in the last 12 months, which represents just over one-tenth of 1% of the 600,000 debilitated children in the U.S. who suffer from IBS and are in strong need of IV stem. I want to start by highlighting the sustained and increasing demand for IV stem. While our revenue growth has accelerated in recent quarters, the facts remain that we are still treating a minuscule portion of the addressable market because of the two factors we have discussed around national policy coverage and the CPT code. The positive change we do see here is largely due to accounts more comfortable with billing and coding, physicians seeing the academic society guidelines abstract, stating PENFS has the highest grade of evidence, and only the very slightest insurance policy coverage taking effect to date. On average, selling prices for patients receiving IB STEM through financial assistance are roughly 65% below our list price. The insurance barrier is causing us to leave significant dollars on the table, as we have discussed on many calls previously. As insurance coverage continues to increase across the country, the percentage of sales through full purchase orders will also increase. This is why our number one priority with the Category 1 code imminent continues to be written insurance policy coverage as we know the Cat 1 code becomes effective in roughly nine months from now. Our plan of action is clear. We believe that strong peer-reviewed publications and key society support from the likes of Mastigan and the American Academy of Pediatrics result in successful coverage from insurance companies, which result in strong revenue. Our internal prior authorization team continues to grow and be successful as it reduces the workload for clinic staff, which allows greater access for pediatric patients, and ultimately assisting in acquiring a permanent billing code. We believe that in time, most accounts nationally will move the prior authorization to the NeurAccess team as we see more and more added each quarter. We expect revenue growth to continue to accelerate meaningfully as we move toward our goal of cash flow breakeven based on the two catalysts that we've discussed today in insurance coverage and the Category 1 CPT code, and again, the commercialization of REDD. Let's talk a little bit more about REDD. or the rectal expulsion device product, which we believe to be a great opportunity for neuraxis. We now have FDA clearance, which allows us to soft launch the technology. Red is a self-inflating balloon that is an easy-to-use, office-based, point-of-care, interrectal function test to identify patients with chronic constipation due to pelvic floor dysinertia and who are unlikely to improve with increased laxative use. The current treatment involves much trial and error by the physician as to which treatment will work, and REDD will allow the physician to streamline the diagnosis and choose the best treatment option after the first visit, which is a real win for the patient. Because the technology already has a Category 1 CPT billing code assigned to the procedure and strong national reimbursement, we believe the providers will be able to bring this clinically beneficial technology to their practice immediately. In summary, we are pleased with continued and consistent execution of building the foundation of strong data and academic society support. Nothing happens as fast as we want, but make no mistake, we are inching very close to the final insurance policy coverage and effectiveness of the CAT I CPT code, which we believe sets the stage for seamless patient treatment and result in significant growth and profitability. I'll now turn the call over to our CFO, Tim Hendricks, to discuss the financials. Tim?

Thanks, Brian. And let me add my welcome to everyone joining us on the call this morning. These financial results, which I'm about to walk through, were included within our press release, which was issued earlier, and also provided in more detail in our 10-K, which was also released this morning. I will add some color on key areas of the financial results, as well as an outlook on certain areas. The hard work that our team has put in the last few years is beginning to bear fruit The strong momentum that began in the third quarter last year continued in the fourth quarter and we're even seeing it into the first quarter as Brian previously mentioned. The good news is that we are only in the early innings of our ramp as we expect the number of covered lives to continue to grow. In addition, we are optimistic with regards to the commercialization of red. We actually booked our first order in the first quarter of 2025 and expect demand to pick up in the second quarter. through the rest of fiscal year 2025. Given our current cost structure, our goal as a company to reach cash flow breakeven is achievable and a function of our sales volume given our strong gross margins. Our recent successes in obtaining substantially more insurance coverage keeps us on that path. With that, I'll go through the financial highlights in detail. Revenues in the fourth quarter of 2024 were 761,000, a 43% compared to $531,000 in the fourth quarter of 2023. Unit sales increased approximately 45% due to growth from patients with undiscounted insurance reimbursement and the company's financial assistance program that provides discounts to patients without insurance. The company has made great strides in recent months in gaining insurance coverage, and recent results are indicative of that success. Revenue in fiscal year 2024 was $2.7 million, an increase of 9% compared to $2.5 million in fiscal year 2023. Unit sales increased approximately 19% year over year due to continued growth in patients that are provided discounts through the company's financial assistance program. As Brian mentioned, the strong momentum has continued in the first quarter of 2025, which we expect to be our third consecutive quarter. of revenue growth year over year. And as mentioned before, we remain highly focused on expanding our insurance coverage. Despite the inherent lag from insurance coverage device orders, which we have spoken about before, recent performance indicates strong demand and acceptance on the part of healthcare providers and patients for our product. Gross margin in the fourth quarter of 2024 was 86.4%, the same as the fourth quarter of 2023. Although we saw a significant increase in discounted financial assistance units delivered to outpace the growth in the higher margin undiscounted full reimbursement program, we had substantial enough growth to maintain a steady gross margin year over year in the fourth quarter. And that trend is evidence of our future opportunity. With the Category 1 CPT Billing Code in place for January 1 of 2026, The devices currently sold at a discount will eventually transition to full reimbursement revenue upon insurance coverage, which will boost our future revenues and gross margin. Gross margin in fiscal year 2024 was 86.5% compared to 87.7% for the full year 2023. The 120 basis point decline was due to growth in device deliveries from the company's financial assistance programs that are discounted to patients without insurance coverage. Again, as the Category 1 CPT Billing Code takes hold in 2026 and beyond, we expect gross margins to expand. SG&A expenses in the fourth quarter of 2024 were $2.1 million, an increase of 2% compared to the fourth quarter of 2023, which was $2 million. The increase was due to, one, the hiring of market access, sales, and finance team members, and two, the introduction of a short-term incentive plan in 2024, mostly offset by cost savings of third-party service spend as the key personnel hires performed the work of previous vendors. SG&A expenses in fiscal year 24 were $9.5 million, an increase of 7% compared to $8.8 million in fiscal year 2023. The increase was due to one incremental headcount, to build out the market access sales and finance teams. Two, severance charges related to the company's prior chief operating officer. Three, one-time advisory costs. Four, the annualization of legal, insurance, investor relations, board of directors, and stock exchange listing costs as a publicly held entity as the company went public in August of 23. Five, the introduction of a short-term incentive plan in 2024. and six, higher advertising costs to expand market awareness, partially offset by post-IPO consulting and recruiting fees and IPO bonuses in 2023 that did not recur in 2024. Operating loss in the fourth quarter of 2024 was 1.5 million, an improvement of 10% compared to 1.6 million in the fourth quarter of 2023. That improvement was primarily due to higher sales volumes partly offset by slightly higher SG&A costs that I previously discussed. Operating loss in the full year 2024 was $7.2 million, an increase of 7% compared to $6.7 million in fiscal year 2023. The increase was due to higher SG&A costs, partly offset by higher sales volume. Net loss for the fourth quarter of 2024 was $1.5 million, a decrease of 73% compared to 5.3 million in the fourth quarter of 2023, primarily due to a lower operating loss and a $3.7 million charge related to the extinguishment of debt upon the company's IPO in 2023. Net loss in fiscal year 2024 was 8.2 million, a decrease of 45% compared to the $14.6 million loss in fiscal year 2023, primarily due to the absence of debt discount, issuance costs, and debt extinguishment charges relating to the company's IPO in 2023, partially offset by a higher operating loss. Our cash on hand as of December 31, 2024 was $3.7 million. The company held no long-term debt as of December 31, 2024. However, we did have $154,000 of short-term debt related to the standard financing of our annual business insurance premiums. Cash used in operations in fiscal year 2024 of $6.1 million was $595,000 lower than fiscal year 23 due to more issuance of common stock instead of cash for certain services and lower interest payments from the conversion of debt than the prior year. And with that, let me turn the call back over to Brian.

Thanks, Tim. To sum this up, as many critical milestones as we have recently seen come to fruition, we are still very early of what we see as strong top and bottom line growth over the next few quarters. The consistent execution of our commercialization strategy is beginning to bear early fruit as we see from the growth acceleration in the last two quarters. We are also achieving milestones that will enable continued growth, as I spoke to the Category 1 code, increased insurance coverage, and the expansion of our 510K clearances. Furthermore, we remain excited about our opportunity with REDD, which we have just recently soft-launched and has the potential to drive significant revenues in the coming quarters. With that, operator, we'd be happy to take any questions. Thank you.

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Okay, we have some questions that have been sent to us by investors. Brian, can you talk about the significance of receiving the Category 1 code and the five 10-K extensions?

Well, I'll speak to the Category 1 code. Look, this is something we've been working on for five or six or seven years. It's extremely difficult to get a Category 1 code due to the utilization requirements and the data requirements, which speak to the accomplishments in those two areas, it's hard to explain the significance of the Category 1 code to the audience, especially if you're not familiar with the med tech space and RVUs. If you are familiar with RVUs, you'll understand that physicians, especially 95% of our physicians that we work with are pediatric gastroenterologists employed by the children's hospitals, and they're measuring STIC on a daily, weekly, monthly, annual basis, or RVUs. And so to be able to receive RVUs for a procedure, you know, in a sense that's their currency. So to do IV STEM without an RVU, as I mentioned in the call, is essentially donating their time. So that's the first aspect of the CPT code is that these physicians will be recognized for their time and it will actually, you know, it goes towards their annual. So I think that speaks for the obvious. Number two, most Medicades and many commercial insurance companies don't recognize the Category 3 code, which we have now, which makes the prior authorizations very difficult. The Category 3 code also means that the children's hospitals have to build what's called a charge bundle, which is very time consuming. And between that and the prior authorization difficulty, there's a reason that the revenues are where they are today. And so that will streamline The prior authorizations will make it much easier for the chief revenue officer and the billing teams at the children's hospital, and it brings significant credibility to the payers when you have a Category 1 CPT code. And there are other angles to the Cat 1 code, but that's the first part. The 510K extension, look, there are a lot of kids that are 8, 9, 10, 19, 20, and 21 that are equally sick as the 11 to 18 years of age. So we went from 11 to 18 to 8 to 21, so it's about a 75% increase, 80%, 85% increase in total addressable market. And we've seen just since this age expansion, I don't know exactly what percentage of the increased revenue it is, but we've significant feedback from the physicians that they're very appreciative of the age expansion and they're utilizing this in full force and we expect that to expand or continue to be utilized.

Okay, we have a question for you, Tim. Can you talk about the variability of the gross margins and how to think about gross margins on a go-forward basis?

Sure. So our reported gross margins are in the mid to high 80s. When we sell an IV stim device to a patient that's covered by insurance, our gross margins are higher than that. However, the reason... that you see the gross margins in the mid to high 80s is because of our financial assistance program, which we're very excited about and it continues to grow. One of our guiding principles is that we want to make sure that we treat all patients. And in many cases, patients do not have insurance coverage or they have inadequate insurance coverage. And so they will come to us seeking treatment And we want to make sure that they receive that treatment. So what we will do is we will discount based on income levels of the patients. And Brian previously mentioned in the call today, on average in financial assistance, we discount up to 65% off our, you know, list price, $1,195. But even at that discount, our gross margins are pretty healthy because you can see as a blend throughout the whole company, we're in the mid, to high 80s. And what that is going to translate in the future, in particular when the CAP1 CPT code takes hold, we obviously expect covered lives to increase, insurance coverage to increase, and it will then take our patients out of inadequate or no insurance coverage into insurance coverage, allowing the higher full reimbursement price to be charged, and we fully expect that our gross margins when we move into 2026 and beyond will increase as a result of that transition from the CPT-1, CPT Category 1 code.

Okay. We have another question sent to us. Brian, what are some of the early learnings from the red in the commercial mode that you're doing now?

A great question. We had done some market feedback, significant market feedback before when we considered licensing this technology from the University of Michigan. And some of the key points were and reasons we licensed this were it had a category one CPT code. It has a Medicare reimbursement. It's reimbursed by commercial insurance already. And we knew there was an unmet need. Since the soft launch, look, we just launched this. And I would just tell you the feedback has been what we expected. I think, you know, if we underestimated anything, it's the size of the practices, and they have boards and they have practice administrators and CEOs, and there's a process, although most are private and not academic. There's still a process to get through, but the feedback, I think, from a positive standpoint, has been the numbers and the feedback we're getting are the usage expectation from the physicians is higher than what we thought it would be. So, look, the physicians are excited. The commercial force is excited. Very, very happy, very excited. The conferences are going well. We're excited. Look, Q2 will be telling. We'll see how Q2 goes, Q3 and Q4. But we're bullish that these are meaningful revenues for us.

Okay. A question for you, Tim. Given the expected cost structure, what level of revenue do you need to achieve break-evens?

So at our current run rate, our current cash burn run rate is about $6 million annually. And if you, you know, take that and then translate into revenues, depending on when we break even, right, in the not too distant future, those break even revenues will be in that $10 to $12 million range.

Okay, thank you. A product question, where are your products manufactured and what is your exposure to any potential tariffs?

That's a phone call I have in 30 minutes, but 95% of our technology is sourced and manufactured here in the United States. And I believe the one component we get from overseas is with a country that has no tariff either way, and I don't believe there's a planned tariff either way. So minimal to zero, and again, I have that call in 30 minutes to discuss that, but as of right now, it doesn't appear that we'll be affected.

Okay, thank you. What is the development timeline for a second-generation IB STEM device, and how will that differ from the current version?

um we're working on generation two and you know sometime in 2026 we expect to have that it will have you know i would tell you uh a different look more modern look um it would it would uh we haven't we haven't finalized this i mean um the one question we get our call sometimes is patients don't feel the device which is a good thing and they think it's not working So we're looking at putting some type of infrared light that blinks once every 60 seconds to show that it's working. And there are some other things we're working on in the background that are really going to advance and should improve outcomes in children. And we should be able to predict who responds and who doesn't around heart rate variability and Autonomic dysfunction and vagal insufficiency. But these are things we're working on and would be part of potentially this next device and would be potentially part of the next version. But these are all things that are in the future. We have a lot of ideas. We're in the research phase of different things. We're in the development phase of version two. But the device we have works outstanding. We have virtually no complaints. So, yeah, I hope that answers the question.

Okay, we have another question for you, Brian. What is the response after a three or four week course of IV stem treatment and what percentage of patients come back for additional treatment courses?

That's a good question. We've got good data right now at six and at 12 months. We have a multi-center, about 300 patient registry. It was published last year. It had good data, statistically significant data. You know, we don't have, you know, the physician feedback is pretty straightforward. They're roughly 70% of patients. This is anecdotal. This is not the data. But if somebody wants to schedule a separate call with Dr. Moreno to go into the data, we'd be happy to do that. But roughly 70% of patients have significant long-term relief. That's the feedback from physicians. You obviously have non-responders, and you obviously have patients that have some response. But this is not something that once someone has four weeks of treatment that next month or two months from now you need four weeks of treatment again. The results are sustained, and we've got multiple studies. And we've got 16 studies now on this, including two placebo-controlled trials. We've done 10 or 11 different types of studies, and this all goes into the fact that it was part of why we had such strong support from the American Academy of Pediatrics, and they submitted the Category 1 CPT code application alongside us. But the data are really strong, and the longevity of the treatment is sustainable and statistically significant.

This does conclude today's Q&A session. I would like to go ahead and turn the call back over for closing remarks. Please go ahead.

I'd just like to say thank you to everyone for joining us today. We appreciate the questions, and we look forward to communications with you again very soon via press release, and obviously we'll have quarter one results out in the coming weeks in quarter one call. in May, and we'll announce that. So thank you again. Have a great rest of your Thursday.

Thank you all for joining today's conference call. You may now disconnect.