Earnings Labs

NeurAxis, Inc. (NRXS)

Q1 2024 Earnings Call· Wed, May 22, 2024

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Transcript

Operator

Operator

Good day, and thank you for standing by. Welcome to NeurAxis Reports First Quarter 2024 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. [Operator Instructions] Please be advised, today's conference is being recorded. I would now like to turn the call over to your speaker today, Ben Shamsian. You may begin.

Ben Shamsian

Analyst

Good morning, everyone, and thank you for joining us for NeurAxis' first quarter 2024 financial results and corporate update conference call. Joining us on the call is Brian Carrico, CEO of NeurAxis, and Tim Henrichs, 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, you can send in a question through the portal utilizing the Ask a Question box or by simply e-mailing questions to nrxs@lythampartners.com. If you are dialed into the call live and would like to ask a question, you can follow the instructions provided by the operator, by pressing the star and 11 button. 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 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 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. NeurAxis undertakes no obligations 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.

Brian Carrico

Analyst

Thank you, Ben. Good morning, and thank you for attending the first quarter 2024 earnings call. During today's call, I will highlight the many recent accomplishments in our revolutionary neuromodulation technology commercialization strategy. We will also discuss the milestones and growth plans for 2024 and beyond as we continue to execute the commercialization of our market--leading PENFS technology. Following my remarks, Tim Henrichs, our CFO, will review our financial results the first quarter of 2024. For those of you new to our story, NeurAxis is a leader in the field of neuromodulation. Our initial focus is the pediatric and adult GI space, specifically on disorders of gut-brain interaction, or DGBI, which include functional abdominal pain associated with IBS, functional dyspepsia, irritable bowel syndrome and more. With our targeted indications, we have a large total addressable market with $9 billion on the pediatric side and over $14 billion in the adult side. While we are currently focused on the pediatric space, we are evolving into the adult space later this year on two fronts, which I will discuss later. Our proprietary technology can be referred to as Percutaneous Electrical Nerve Field Stimulation, or PENFS. Percutaneous Electrical Nerve Field Stimulation targets nerves, including the vagus nerve to alter pain transmission at the CNS or central level. This is accomplished via a set of electrode needle arrays placed into and around the auricular area. We currently have one authorization from the FDA for functional abdominal pain associated with irritable bowel syndrome in children 11 to 18 years of age. We are also working on other indications, including, but not limited to, functional dyspepsia in children, post-concussion syndrome in children, pediatric chemotherapy-induced nausea and vomiting, and our first adult indication of functional abdominal pain and irritable bowel syndrome. With that brief review behind us,…

Tim Henrichs

Analyst

Thank you, Brian. 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 and were also provided in more detail within our Q1 '24 10-Q. I will add some color on key areas of the financial results as well as an outlook on certain areas. From a big picture standpoint, we are continuing to execute on our plans, including the commercialization of our PENFS technology. We have been successful in leveraging our 14 completed studies to gain insurance coverage. We have 22.5 million lives currently under coverage and expect that number to continue to grow through the end of the year. In addition, we are optimistic with regards to the commercialization of RED in the fourth quarter. As such, we expect revenue growth in the back half of 2024. Given our current cost structure, our goal as a company to reach profitability is achievable by a function of our sales volume given our strong gross margins. Our recent successes in obtaining substantially more insurance coverage since December keeps us on that path. Finally, we have strengthened our liquidity position heading into '24 as we secured $6.1 million in financial commitments through March of 2025 via convertible notes since November from strong long-term investors who know the medtech space well with over $1.5 million funded in Q1 of '24. With that, I will go through the financial highlights in detail. 2024 first quarter revenues were $647,000 compared to $805,000 for the same period in 2023. While revenue was down 19.7% in the quarter compared to last year, we had more accounts ordering from us and we had more patients coming to us via our patient assistance program, and Brian mentioned earlier what those numbers turn into…

Brian Carrico

Analyst

Thank you, Tim. Let me conclude the call where I started. I cannot stress enough how the consistent execution continues to lay the foundation and pathway to meet our goals. This has led to the milestones we are achieving and is setting NeurAxis to achieve accelerated growth in the second half of 2024 and into 2025. We remain focused on leveraging the strong data from our studies leading us to insurance acceptance from the covered lives we have today to a significantly higher number by the end of 2024. Furthermore, we remain very excited about our opportunity with RED, which we expect to become commercial in 2024. With that, operator, we would be happy to take any questions. As a reminder, you can ask a question on the webcast by typing into the Ask a Question box, or if you are dialed-in and would like to ask a question, then press star, one, one.

Operator

Operator

[Operator Instructions] And I'm not showing any questions on the phone lines.

Ben Shamsian

Analyst

Now, first, how do you plan to allocate capital to drive revenue in 2024 and 2025?

Brian Carrico

Analyst

Well, first, we want to ensure we don't build a commercial machine. I talked about this on the first call. We don't want to build a commercial machine in areas where we do not have policy coverage, and therefore, a real revenue source. So, we are placing reps in areas with positive PENFS policy coverage. Second, we are spending some capital to educate families about the technology and physicians about the data where there is insurance coverage. Third, we're using resources to leverage our data to drive more policy coverage. And additionally and equally as important, we are putting time and money toward the RED technology via the FDA process and commercialization.

Ben Shamsian

Analyst

Great. Thank you. We have some more questions that have come in. Can you speak about your path to profitability?

Brian Carrico

Analyst

Yes. As we mentioned on the call, we already have enough patients coming to NeurAxis to really push towards that profitability number from a cash flow standpoint and we can dive more into that number on the next call. And this is only from a fraction of the children's hospitals nationally as we mentioned earlier. Second, this answer continues to be about how fast we can gain coverage nationally. In areas where we have policy coverage, we still see most patients coming from other payers. We've got some really nice Blue Cross Blue Shield policies, and we still see, 60%, 70%, 80% of the patients coming from those children's hospitals from other payers, which speaks to my point earlier about us only having about 7% of covered lives nationally in place and those policies have either just taken effect or they have not taken effect. So that's the biggest issue right now.

Ben Shamsian

Analyst

Great. As a reminder, you can ask questions either on the chat or by following the operator's instructions. We have some more questions that were sent in to us. The biggest challenge at this point to gaining written policy, what do you see the biggest challenge there in terms of written policy?

Brian Carrico

Analyst

Well, it's speed, how fast can we get this policy coverage in place and executed. The data is now published and in place, so the key is gaining the attention of the payers to get this policy coverage written and effective. The good news is that we used to be told we need more data and we very rarely, if ever, hear that now. We often aware of policy coverage that cannot be announced until the payer announces it. So, we've talked about this in previous calls. We could be aware of policy coverage now, significant policy coverage that we are aware is becoming effective, but it's not been announced by the payer. So, we are not able to announce that yet.

Ben Shamsian

Analyst

Okay. Great. Questioner is asking, what plans do you have to increase visibility among the investment community?

Brian Carrico

Analyst

Significant plans. We're doing -- we have significant weekly meetings with investors. We have two Investor Relation outsource. We have one, Lytham Partners, that is -- we have multiple, as I said, weekly meetings on with investors, new investors and investors who are potential investors And then, we're doing multiple conferences. We're starting to do monthly conferences both virtually and in-person, which we would hope would drive interest in the company and ultimately the stock price and the stock volume.

Ben Shamsian

Analyst

Okay. Next question regarding Q1 revenues. Are you concerned about the decline in the Q1 revenues relative to last year?

Brian Carrico

Analyst

Well, on the surface, it's frustrating and -- but we're not concerned, no. So, many accounts had issues with prior authorizations this Q1 versus a year ago and we know that's a short-term issue and the number of patients who came to us were up significantly. The demand continues to grow, and this is again from only a small number of children's hospitals. Most children's hospitals are waiting on policy coverage before the Chief Revenue Officers will allow the product in. We're extremely encouraged by the continued ramp in demand, which we know will translate to revenue in the coming months and year.

Ben Shamsian

Analyst

Okay. Operator, I believe I don't see any more questions.

Operator

Operator

And I'm not showing any other questions on the phone lines either. So, I guess, we'll turn it back to Brian for closing remarks.

Brian Carrico

Analyst

Sure. I just want to thank everyone for joining the Q1 call and look forward to talking to everyone in the coming weeks and months. Have a nice day.

Operator

Operator

Thank you, ladies and gentlemen. This does conclude today's presentation. You may now disconnect, and have a wonderful day.