NeuroOne Medical Technologies Corp (NMTC) 2025 Q1 法說會逐字稿

Greetings and welcome to NeuroOne Medical Technology virtual investor webinar. (Operator Instructions) As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Mr. David Rosa. Thank you. You may begin.

Thanks, Rob. First and foremost, I want to wish everyone a good morning and a special thank you for attending the webinar. My goal for this call is to discuss what our fiscal year plan is for 2025. I'll provide you with an update on our OneRF ablation system and how that's going and also more or less give you a glimpse into where the company is heading.

So this morning, I'm going to be reviewing a new corporate slide presentation which will be available on video here. But it will also be available on our website as well if you'd kind of like to go back and review some of what I discussed.

I also want to give you a heads up to keep an eye out on the website for an interview with one of our patients and neurologist from the Mayo Clinic in Jacksonville, Florida, regarding the impact of our system. So I expect to have that posted in the near future as well. And I really think you're going to enjoy hearing about -- hearing from this particular patient as well as the neurologists regarding the OneRF technology.

So also some of what I discussed this morning will be topics I have touched on previously, but for the sake of anyone new to the story, I'll apologize for any repetitiveness. I'll also be advancing the slides, so there might be just a slight delay from one slide to another.

Let's get started. So first, obviously, is a forward-looking statement, which I'll let you read at your leisure. But let's talk about NeuroOne and what we do. NeuroOne is a company that develops and commercializes thin film electrodes for neurological applications. And today, we're very proud that the company has three FDA 510(k) cleared electrode families.

We've got numerous patents assigned to the technology with also additional patent applications in progress -- in process. And we also have exclusive partnerships with prestigious organizations that I'm going to touch on as we go through the presentation.

So prior to joining the company, I had spent a great deal of time speaking with our neurologists, our neurosurgeon advisers at the Mayo Clinic. In addition, to those at the University of Wisconsin, I was really trying to focus on what the state of the industry was.

And what they all consistently described was a scenario where electrode technology, in particular, really hadn't changed significantly from the 1950s. And we at NeuroOne clearly felt there was an opportunity to upgrade the technology.

The two areas that we thought our technology could provide significant differentiation was in reducing the invasiveness of the procedure. And that's really attributed to our thin film characteristics, but also the potential to reduce procedures/hospitalizations by using the same electrode for multiple functions. And today, I'm really more convinced of our capabilities to achieve this.

So one of our close partnerships, as you likely know, is with the Mayo Clinic. They were really the first investor in the company and actually remain a shareholder today. Even more valuable to the company really has been the guidance and the support that our advisers there provided over the years, whether it be feedback on our development efforts or testing that they've conducted on some of our devices in development. And really, the Mayo Clinic remains a critical partner for us today.

The next critical partnership I'll address is with Zimmer Biomet. Now this relationship began in 2020 with the licensing of our Evo Cortical and sEEG electrodes. Those electrodes had received clearance just for diagnostic-only applications.

More recently, we announced our relationship had expanded to include the OneRF ablation system, which is the first combination diagnostic and therapeutic system cleared by the FDA. And that occurred in December of 2023.

I think the synergies for both parties were obvious. Zimmer has a leadership position with their ROSA robot, which is used in the majority of these diagnostic procedures. And really, the goal with that technology is to accurately place the electrodes based on where the neurologist and neurosurgeon determine.

Our electrodes, on the other hand, provide Zimmer with a disposable product that they lacked that are used in all of these procedures. And I would estimate that an average range of devices used in these procedures would be roughly 13 to 15 a case, although in some cases, we've seen as many as 25 used.

So let's talk about the market opportunity for a minute. So when you look at collectively all our products address a multibillion-dollar market opportunity. Some of these sectors are more penetrated than others, like spinal cord stimulation for back pain.

But when you look at our target markets, your epilepsy, brain ablation, Parkinson's disease, spinal cord stimulation, although we're also interested in pain management as a whole, and other areas of the body. And then finally, drug delivery, which we believe is going to be an important market to develop in the future.

So let's now move on to discuss the technology platform. Sorry about that. First up, as I mentioned, the company has three FDA 510(k) clearances. The first two devices were the Evo Cortical and sEEG families, the most recent one being the OneRF ablation system, which was cleared by the FDA in December of 2023. All three of these product families are marketed by Zimmer Biomet.

We also have in development, a family of thin film implantable electrodes. These devices are intended to provide diagnostic and therapeutic functions using stimulation for pain relief. And the last platform is our drug delivery system, which I'll go into more detail in the next coming slides.

So the first product family I want to discuss is the Evo product family. As I mentioned, this family has an FDA 510(k) clearance for diagnostic purposes. And these devices are used primarily in epilepsy and brain tumor cases to precisely identify either the areas in the brain that are triggering seizures or they're used to define the borders of the brain tumor. This really provides a road map for surgeons to remove the targeted tissue. The Evo Cortical electrode, when compared to competitive technologies is thinner by a wide margin. And you'll even hear in an upcoming slide the benefits of having these thin film properties when we talk a little bit more about spinal cord stimulation for back pain.

Our sEEG product family, that encompasses most of really the current usage today, given that the surgical method is much less invasive than placing cortical electrodes. So most patients today prefer procedures using sEEG electrodes. And to give you an idea regarding the sEEG footprint, I've been asked how large are these devices. They are 0.8 millimeters in diameter. So we're really talking about devices that are -- that look like thin wires.

Next up is the OneRF ablation system. As I mentioned previously, NeuroOne has the only sEEG electrode with an FDA 510(k) clearance for both diagnostic and therapeutic use. We really believe this technology is a game changer, and we're seeing it in the field on a daily basis.

So instead of patients having to undergo two hospitalizations with multiple procedures that are typically a few months apart, what they can do now is undergo one hospitalization that would allow the neurosurgeon to use the same electrode for both diagnostic and ablation purposes.

So far, the feedback that we have from neurosurgeons is that this technology may actually encourage more patients to have this procedure if they know there's an opportunity to only undergo one hospitalization to treat their condition. So far, we're very excited what we've seen in terms of the results of this technology. And since our limited launch in April, none of the patients that have been treated have returned for a follow-up procedure.

We previously mentioned that the majority also of these patients remain seizure-free. All the ablations have been performed at the patient's bedside. And this really represents a true savings cost because it frees up the use of the operating room for other procedures.

In addition, now we're excited to have Zimmer expand the commercialization with their sales force. But beyond this application, we really intend to leverage our ablation system to treat pain in other areas of the body. We mentioned on our last quarterly call that our next targeted application is for treating facial pain, and we expect to submit a 510(k) for that application to the FDA in the first half of calendar 2025.

Moving on to our spinal cohort percutaneous paddle lead or electrode. I mentioned previously that our thin film technology had benefits and other applications beyond just diagnostics. And this is really a great example of one of those benefits.

So today, patients that are treated with stimulation for lower back pain, they get one or two sEEG-like electrodes or electrodes that look like thin wires to provide the stimulation for pain relief. And again, these devices are only roughly 0.8 millimeters in size. So you can imagine that there's a limited amount of stimulation that each of these devices can provide.

So what we've demonstrated so far in animal and cadaver models is the ability to place a larger -- what looks like a cortical electrode through a needle so that we can provide a larger stimulation area without the need for any surgical incisions. And there have been many companies prior to us that have previously failed in this attempt. The reason for that was their electrode technology were just too thick to place percutaneously or through the skin without an incision.

I mentioned in one of the prior slides that today, this market generates over $3 billion in revenue. But we really believe that our technology has the potential to not only be applied for these indications, but to be used to provide pain relief in other areas of the body as well. This is -- again, we always refer to our technology as a true platform technology, and this is just another great example of that.

So let's talk about the final product family, and that is our drug delivery program. Now this electrode technology would allow neurosurgeons to first identify the area of the brain that they would want to deliver, say, a gene, cell-based therapy or some sort of medication and to be able to place it without the need for MRI guidance.

The electrode would then be connected to tubing, which would be connected to a syringe and a drug delivery pump, which would allow for both the delivery of whatever the therapy is, but also for follow-up monitoring. And really, what this monitoring would be able to do is identify the effectiveness of the drug. Again, another multifunction capability that we can offer that is really unique to NeuroOne's technology.

Now today, there's no approved gene- or cell-based therapies to treat neurological disorders. But we fully expect that with all the clinical trials that are in process today, there will be one in the future. And I think this may be a good point for me to stop and summarize where I see our technology going.

What we want to be able to do is really provide the neurosurgeon and pain specialists with a toolbox. So for example, with neurosurgeons, the feedback that we've received is that they will continue to use ablation and stimulation to treat these neurological issues, but also pharmacologic therapies in the future. And what we want to be able to do is have an electrode platform that addresses all these needs.

Now let's talk about pain specialists. For them, we want to be able to offer both percutaneous solutions that have ablation and stimulation capabilities to treat pain. This would, again, provide us with a unique advantage of NeuroOne's platform technology.

So in addition to that, how are we going to accomplish this? And we really feel that we have the team and advisers to do so. So our management team today includes executives that have hailed from large companies such as Medtronic, Boston Scientific, St. Jude and Abbott, but also that have start-up company experience as well. We also have a great deal of experience just with thin film electrode technology. We have internal employees that were hired from Neuralink, which many of you may know is Elon Musk's company.

In addition, our Scientific Advisory Board includes neurologists, neurosurgeons, scientists from some of the most prestigious institutions in the company. And they -- all of these physicians that you see on this slide have been working with us since the early days at NeuroOne.

Next up, regarding our current financial status. You may have seen our press release this morning, where we preannounced preliminary fiscal Q1 2025 revenues of $6.2 million. Now that includes two major components. One is product revenues that we expect to be approximately $3.2 million, but also a onetime collaboration revenue recognition that equals $3 million, that was derived from the distribution agreement that we just announced with Zimmer Biomet.

We also reaffirmed our fiscal 2025 product revenue guidance in the range of $8 million to $10 million, as well as the expected product margins in a range of 47% to 51%. Both of these represent substantial increases over fiscal 2024.

Now the revenue guidance that we provided, that does not take into account the $3 million of collaboration revenue that I just referred to that we expect to be recognized this quarter. And I think the last point that I would make is that today -- as of today, the company does not have any outstanding debt at this time.

So what are some upcoming potential catalysts for fiscal year 2025? Obviously, the full launch of the OneRF system by Zimmer, that will be a key one. And with that, we expect substantial increases in product revenue. In addition, the expected 510(k) submission for facial pain, which again, we expect in the first half of calendar 2025, would be another.

We also expect to complete our drug delivery system which would be followed by an FDA 510(k) submission. And when you look at our overall plan for fiscal 2025, we also think there's upside in the plan. We've mentioned before on previous calls that we continue to really work towards securing additional strategic partnerships by leveraging our ablation and stimulation technologies, but to primarily target pain management.

So what are the key takeaways? In summary, really, what I want you to take from this call, and I'll apologize for reading from some of the slides, but I believe it's important. And that is, number one, this technology is a platform technology. And so far, we have evidence that it improves clinical outcomes for patients suffering from neurological disorders.

The second is we're the only company with a single device that can provide -- that can actually perform multiple diagnostic and therapeutic functions. Those functions would be recording electrical activity, tissue ablation and tissue stimulation, all using the same electrode.

And with respect to our success with FDA, well, today, we've been successful, achieving multiple FDA 510(k) clearances. And as of today, that represents three product families, and we have others in our product pipeline.

Our devices, they target multibillion-dollar markets, which I've already touched on. We've got world-class partnerships with world-class organizations such as the Mayo Clinic and Zimmer Biomet. So today, I really feel that we're best positioned to offer that complete toolbox of diagnostic, ablation, and stimulation electrodes to both neurosurgeons as well as electrodes that are capable of being placed minimally invasively or percutaneously to treat pain using ablation and stimulation.

So with that, I want to thank you for your attention. And Rob, why don't we take a few questions?

Absolutely. At this time, we'll be conducting a question-and-answer session. (Operator Instructions) Alex Silverman, AWM Investments.

Hey, good morning, Dave.

Good morning, Alex.

Thanks for doing this. This is a helpful overview. Can you walk us through what needs to take place between now and the Zimmer full launch?

Training. But one of the things I'm pleased to actually comment on is that even though we have not completed training with all Zimmer sales personnel, they've actually already performed some unassisted ablations without our assistance.

And this is a much different technology obviously than just placing an electrode and watching it record electrical activity. It's much more active in that the representatives in the cases are actually many times operating the equipment to perform the ablations.

Got you. And complete training should be done by when? In other words, when would the full launch scheduled to take place?

Yeah. I can't give you an exact date because literally on a weekly basis, we're training additional groups. There's approximately 150 people. So we're going to be training for probably another three, four months. But as I said, the good news is this is at least a device that all the reps have used previously. The difference is the ablation piece.

Got it. And along those lines, I assume some portion of this $3.2 million of product revenue is stocking revenue for Zimmer. And some is, I'm sure for current cases, as you mentioned, can you give us a sense of sort of how to think about that $3.2 million?

Yeah. Obviously, it's still early on. And remember that these electrodes that are used for ablation are definitely different than the electrodes that were just used for diagnostic-only purposes. And what we've heard pretty consistently from neurosurgeons is that they will only be using ablation-capable electrodes in the future.

Actually, the limiting factor, Alex, is that in terms of generators -- the RF generators, those are being rolled out over the course of this year. So there are going to be some centers that will still have to use some of the existing inventory of diagnostic-only devices.

But I think it's a little bit too early just because there are still some devices, diagnostic-only devices that are being used. But you're correct. A portion of this is really for stocking, and the other is for demand. And I would say the other key piece in this is while NeuroOne does not have great commercialization capabilities with a few individuals, we initiated a limited launch in April.

And really, over the course of six months, we performed cases at five centers, but there were many other centers that expressed interest to the point of requesting a quote for -- and a proposal for what the consoles would be. So there is some pent-up demand. We just need to get the Zimmer sales force trained -- fully trained. And then it's on to placing systems in the hospitals.

Great. And so along those lines, can you give us a sense of what linearity might look like this year? I mean, if it's three and change millions of product revenue in the first fiscal quarter, do they need to chew through that in the second quarter before they start to order in the fiscal second half?

Yeah, it's an excellent question and it's one that we should have the answer to in the very near future. So we are expected to receive more of a -- I'll say a quarterly product demand from Zimmer, but they are still fine-tuning that. So I think in more or less in follow-up whether it's through a webinar like this or a quarterly announcement, we'll have a better idea of what that quarter-to-quarter cadence is going to look like.

Great. And I guess is -- I guess I may have missed this earlier when you signed the deal with Zimmer. But I guess I didn't realize that there are at least one more milestone payment that's possible. Can you talk us through roughly how much that's worth and what needs to be accomplished in order to receive it?

Yeah. So we haven't disclosed that and that is at Zimmer's request. But there is one additional milestone that's triggered by revenue -- Zimmer revenue. And that would be measured over the course of 12 months.

Got it. Okay. Thanks. I'll put myself back in the queue. Appreciate it.

Sure.

We have reached the end of the question-and-answer session. I'd now like to turn the call back over to Dave Rosa for closing comments.

Thanks, Rob. And again, I just want to thank everyone for attending. And I really look forward to providing future updates to you regarding the progress that we're making with OneRF and our other platforms. Have a good rest of the day and a great weekend. Thanks.

This concludes today's conference. You may disconnect your lines at this time and we thank you for your participation.