NeurAxis, Inc. (NASDAQ:NRXS) Q4 2023 Earnings Call Transcript

The studies include a preclinical study, a placebo RCT, long-term data, health economic data, quality of life data, real-world registry data, and many others. These 14 studies have led to early insurance policy covers for major Blue Cross Blue Shield plans nationally and we have just announced new policies, bringing our total covered lives to over 16 million with multiple payers, both small and large, currently in the review stage. Our goal is to recognize as many covered lives as we can by the end of 2024, which will set the stage for a significant revenue ramp in 2025. From a proof of concept standpoint, we see the children’s hospitals with moderate policy coverage translated into nice revenue. We have two examples of hospitals with moderate insurance policy coverage, and each is on pace to generate over $500,000 in annual revenue in 2024.

When you think about 260 children’s hospitals plus pediatricians’ offices, you can understand why we are bullish on our revenue trajectory in the coming years as policy coverage and coding become formal, and this is what’s only our first indication. One of the more relative proof-of-concept numbers relates to the total number of patients who came to our GPS and prior authorization teams in the fourth quarter. We had 201 patients come to our GPS and prior authorization team in the fourth quarter. If those 201 patients had insurance coverage, the revenue total would have been almost $1 million in addition to the revenue that we did record. Maybe more important is the fact that the majority of those 201 patients came from only about 15 children’s hospitals who are currently using these services of the 260 children’s hospitals.

We have several short-term focused opportunities, including insurance policy coverage, which is being successfully addressed, as mentioned earlier, growing our internal prior authorization team to reduce the workload for clinical staff, which allows greater access for pediatric patients, and ultimately assisting in acquiring a permanent billing code. Regarding prior authorizations, we built and launched an internal prior authorization team in 2023 to help with the time-sensitive prior authorizations required to increase access to care for children. This program has been extremely successful for those children’s hospitals that have transferred their prior authorizations to NeurAxis. We believe that in time, most accounts will move their prior authorizations to the NeurAxis prior authorization team.

Regarding the billing code, we have our own technology-specific billing code now, which is helpful in some areas but can be challenging for children’s hospitals when building their charges to bill insurance. And this has caused a delay in treating patients even after written policy coverage is in place. As mentioned earlier, we are working towards obtaining the CPT Category 1 permanent billing code. Insurance coverage, though, is by far the most critical component to success, and our team is diligently addressing that. We expect revenue growth to accelerate meaningfully in the latter half of 2024 and into 2025 based on two catalysts, the continued gaining of coverage from insurance companies for IB-Stim or PENFS and the commercialization of RED.

With regards to expanded insurance coverage, we remain laser-focused on gaining policy coverage and shortening the gap between policy coverage effectiveness and utilization with the children’s hospitals. Demand for our product has never been stronger, but expanded insurance coverage is critical to growing revenues. While we have 16 million lives currently under coverage, most of them have been in place for less than 90 days or are not yet effective. It is important to appreciate that there’s typically a 90 to 120 day lag from the time coverage is gained, from the time insurance companies for PENFS to when hospitals begin purchasing the product, as time is needed for billing teams to put the proper processes in place. As such, we expect to see a revenue ramp as the year progresses just from the 16 million lives we haven’t recovered today.

But we of course also expect that covered lives number to significantly increase by the end of 2024. Regarding RED for adult patients, we are cautiously optimistic for FDA clearance this fall, with commercialization commencing in Q4. Let’s speak a little more about RED, or the rectal expulsion device product, which we believe to be a great opportunity for interactions. RED is a self-inflating balloon that is an easy-to-use, office-based, point-of-care, intrarectal function test to identify patients with chronic constipation due to pelvic floor dyssynergia and who are likely — who are unlikely to improve with increased [likes] (ph) of use. The current treatment is a guessing game by the physician as to which treatment will work, and RED 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.

We acquired a right to license this product from the University of Michigan where it was developed. We are in track for FDA 510(K) submission late Q2 and are cautiously optimistic, as mentioned, that this product will be on the market before the end of 2024. If successful, RED is expected to bring great clinical benefits to patients, and because the technology has a Category 1 billing code assigned 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 the continued execution of building the foundation on strong data and academic society support. This has resulted in early insurance adoption, which we expect to ramp up throughout 2024, setting the stage for a prosperous 2025.

Before I turn the call over to Tim Henrichs to discuss the financials, I want to welcome and introduce Tim, who joined NeurAxis as our permanent CFO in early February. Tim brings over 20 years of global leadership experience across several industries which is already bringing significant changes and benefits to the finances and daily operations. Tim?