Earnings Labs

NeurAxis, Inc. (NRXS)

Q4 2023 Earnings Call· Tue, Apr 9, 2024

$7.62

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Transcript

Operator

Operator

Thank you for standing by and welcome to NeurAxis Fourth Quarter and Fiscal Year 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to hand the call over to Ben Shamsian with Lytham Partners. Please, go ahead.

Ben Shamsian

Analyst

Thank you and good afternoon everyone. Thank you for joining us for NeurAxis' fourth quarter and full year 2023 financial results and corporate update conference call. Joining us on today's 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 emailing questions to NRXS@lythampartners.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 would 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 to be 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 available -- may no longer be accurate at the time of any [telegraphic] (ph) 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 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.

Brian Carrico

Analyst

Thank you, Ben, and welcome everyone. Good afternoon and thank you for attending the first quarterly earnings call from NeurAxis. We look forward to holding these quarterly calls going forward to update you on our progress. During today's call, I will highlight the many accomplishments from 2023 and our commercialization strategy of our revolutionary neuromodulation technology. We will also discuss the milestones and growth plans for 2024 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 for our fourth quarter and full year 2023. But before that, with this being our first call, I thought it’s best to provide a broad overview of NeurAxis and the opportunities that we believe will drive the company's growth going forward. NeurAxis is a leader in the field of neuromodulation. Our company was founded in 2012 with the vision of using neuromodulation to help treat many of the disorders that exist today and we are the first to market for our indications. Our initial focus is the pediatric and adult GI space, specifically on disorders of gut-brain interaction or DGBIs, which includes 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 23 billion in adults. 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. There are currently no FDA approved drug therapies for children with abdominal pain related disorders of the gut-brain interactions. The current medical treatments, which are off-label drugs, can often have serious side effects and most lack scientific evidence of efficacy. In peer-reviewed…

Tim Henrichs

Analyst

Thank you, Brian. I'm excited to be on board and let me add my welcome to everyone joining us on this call. These financial results, which are currently unaudited, were included within our press release, which was issued earlier and will be provided in detail within our 10-K that will be filed. I will aim to add some color on key areas of the financial results, as well as an outlook on certain areas where I can. At a high level, 2023 was a transition year for us. The company laid the foundation that will allow us to accelerate on the commercialization of this amazing technology. We were able to complete the remainder of the 14 studies which showed the medical community the true effectiveness of our technology and laid the foundation for the insurance coverage that we are achieving. We also were able to take the company public to help fund our growth strategy. While achieving these milestones was expensive and time consuming, these steps lay the foundation that will allow us to accelerate revenues in the coming years as we gain insurance coverage and market awareness. Most importantly, we continue to make strides toward profitability with these investments behind us. Our net loss in the fourth quarter of 2023 was $5.3 million, primarily due to a $3.7 million charge for the extinguishment of debt. Our operating loss of $1.6 million in the fourth quarter of 2023 improved sequentially from a $3 million operating loss in the third quarter of 2023. Given our current cost structure, our goal as a company to reach profitability [as a] (ph) function of our sales volume, given our strong growth margins. Our recent successes in obtaining substantially more insurance coverage since December keeps us on that path. And finally, we have strengthened our…

Brian Carrico

Analyst

Thank you, Tim. Let me conclude with where I started. The consistent execution has led to the milestones we achieved in 2023 and set NeurAxis up to achieve accelerated growth in the second half of 2024 and into 2025. We remain focused on leveraging the strong data from our studies, which will lead us to wide insurance acceptance from the 16 million lives we have under cover today to an exponentially higher number by the end of 2024. Furthermore, we remain excited about our opportunity with RED, which we expect to become commercial in 2024 and has the potential to be our largest revenue driver in the 12 months. With that, operator, we'd be happy to take any questions.

Operator

Operator

[Operator Instructions] We have a couple of questions that were sent in by some investors. Firstly, how do you plan to allocate capital to drive revenue in ‘24 and into ‘25?

Brian Carrico

Analyst

Good question. First, we want to ensure we don't build a commercial machine in areas where we do not have policy coverage. So we're currently placing reps in areas with positive PENFS policy coverage. Second, we're spending some capital to educate families and drive market awareness where new insurance coverage has begun. Additionally, and equally as important, we're putting time and money toward the RED technology via the FDA process and commercialization. Those three points are critical to the question.

Operator

Operator

Okay, great. Thank you. Can you speak about your path to profitability?

Brian Carrico

Analyst

Yeah, profitability is extremely important to us and we believe we do have a clear path. As we mentioned on the call, we already have enough patients coming to NeurAxis each month, each quarter to be profitable And this is from only a fraction of the children's hospitals nationally. Second, we have accounts with decent policy coverage at best who are on pace to do well over $500,000 this calendar year, which speaks to proof of concept. The system is working. The answer to the question is that written policy coverage to meet the demand is the key to profitability. We believe we're on track for that.

Operator

Operator

Okay, thank you. A questioner asked, what is the biggest challenge at this point to gaining written policy coverage?

Brian Carrico

Analyst

Speed. The answer is, how fast can we do this? The data is now published in place. So the key to gaining -- the key is gaining the attention of payers who are being pulled in so many directions. The good news is that we used to be told we need more data, and we very rarely have ever heard that now. The process is now about getting meetings and expediting the policy coverage. For example, we gained one large Blue Cross Blue Shield plan last May, but it was not announced until November. It did not take effect until January 1st of this year. This means that we are often aware of policy covers that cannot be announced until a payer announces it.

Operator

Operator

Okay, thank you. We have a question. Do you expect any IPO related charges to affect financial results going forward in 2024?

Tim Henrichs

Analyst

No, we do not. The IPO was completed in 2023, and any direct costs related to the IPO per GAAP were included in our additional paid-in capital. And so therefore, even within 2023, you don't see them reflected because they were deferred and pushed into the equity section of the balance sheet. There are no draggling costs, if you will, that we would expect to be incurred in 2024. 2024 should be a pure operational year for us.

Operator

Operator

[Operator Instructions] We have another question for you. Are you concerned about the decline in revenue in the fourth quarter compared to last year?

Brian Carrico

Analyst

No, we're not at all. Revenue was very concentrated in 2023 from a smaller number of accounts, and those accounts just ran into coverage issues over the last year and therefore began sending their patients to GPS instead of purchasing devices at full price. We now see a much more diverse customer base each week, each month, with more steady revenue per account, which will increase in spades as coverage and reimbursement mature. We also see an increasing number of accounts that order each month, building a strong base ready to expand revenue as the coverage landscape improves. I mentioned in the call that over 200 patients without insurance coverage came to our GPS and prior office services in Q4. Those revenues would have equaled roughly $1 million additional dollars on top of our revenue if there was written policy coverage in place. And those numbers alone get us the profitability. So now we're sitting in a very strong position. All the revenues are down. That is not -- we're not concerned about that part.

Operator

Operator

Okay. At this point, we don't see any more questions in the queue. Therefore, I would like to turn the call over to Brian for closing remarks.

Brian Carrico

Analyst

Thanks, Ben. Thank you all very much for being with us today. We look forward to communicating with you again soon. Have a nice day.

Operator

Operator

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