Nyxoah SA (NYXH) Earnings Call Transcript & Summary

So an interesting question, Joe. And first of all, we have never chosen the part to be a follower. Like we do believe in our own strength. And as we were just learning also to do the submission for coding, it starts with having the letter behind having the clinical evidence behind. And I can tell you, we do have this -- so we have the evidence, we have the clinical data. We also will come, and this is also a nice bridge to Jay and he will be presenting our publication structure. We will show you this. So in fact, we are in a position of strength in the sense that we can choose -- do we want to submit? We can. We have everything that is needed. We will we submit. We are thinking strategically, as I was saying. We also want to be supportive, collaborative, and we do respect the opinion of the AAO at the next sorry. So here, we are sitting a little bit in a position where we want to collaborate, and we want to have the best intention for the patient. Whether it is having a comprehensive coating or a dedicated code. So that is the outlook. So will we do this? At this moment, I cannot answer this question. Can we do this? Yes, we are prepared in both scenarios. And we will make, I think, the best strategic choice at that time. But maybe we can wait until it's injected again, I cannot make jokes. So no, but maybe we should wait to the outcome, what will happen after the first injection, but we'll never know.

Well, I want to provide a clarification here because a part of the question was -- let's assume that Inspire is successful at the September panel. They're going to have their own CPT1 code for January of '28. Does that -- how does that impact Genio? .

It doesn't .

Exactly.

And I will just put an exclamation on what you said, Olivier. We are positioned -- well positioned to make a choice and we have the criteria in place to do that if it strategically makes sense.

When would the earliest to be at the company would cement for a panel if we find out before that the code has been accepted in the September came?

So what I would say is the weather inspires code is accepted or not, is not part of our strategy because we have reimbursement in place that's going to stay in place. Our decision to submit a code is going to be in conjunction with the -- and so I believe we would submit that in November for the February meeting.

That's been their strong preference .

Yes. So they've said they've actually advised all the companies. Wait until we can all do this together to submit November for the February meeting, which would then come into play in 2029. .

That is correct.

In the February meeting is the first meeting there are 3 each year for the cycle. So February, May and September would be all of 2029. .

And the AMA Rock committee would therefore be in [indiscernible]

It has to be wrapped because prior to rulemaking because federal statute requires that new codes go through rulemaking, so they first rack and then it goes to CMS.

Rock would be in '27 and not 2028?

Correct. Every CPT meeting has a correlating RUC meeting that follows and there's the -- if you actually go to the AMA website, there's a calendar that tells you when it's all happening. .

10 months after the CPT meeting.

And one clarification there for me at least is if Inspire is successful, it's Inspire 5 that's getting rock. It's not Genio.

Correct.

So it's just that product. So it doesn't impact.

It will be based on the description of procedure that they put in the CPT application. .

Correct. I think we answered all the questions on reimbursement. I hope it has provided you with more clarity. Joe and Carla, thank you again for making time to be with us.

My pleasure. Thank you.

Scott, you stay a little bit. So our next topic, we will be digging in a little bit further into the U.S. launch update. I started the presentation by saying you all have seen our press release where we released our global data. So for Q2, again, it was a very successful quarter. Globally, we were over the quarter-over-quarter growth with EUR 7.7 million. But since we are in the U.S., I like also to talk dollars so $9 million, another milestone for the company. Then when we dig into the U.S. because that is where our focus lays with Scott and the entire team. So we will start with the leading indicators then we will end up with revenue and then we will also be a little bit more forward looking what you can expect. Scott, I think you are presenting these numbers with pleasure.

Thank you. So what I call this is predicting the future. I think the last panel reimbursement where we were talking about 2028, 2029, 2030. Let's just start now with Q3, just in the next 3 months. And so you can see on the slide some of the leading indicators that give us confidence that as we go into Q3 or our first full year of launch, that we have a strong confidence in growing at a higher rate in future months, starting with the number of surgeons we've trained. We've trained 262 as of last week which is 27% over the first quarter. And probably more importantly, we have increased demand for surgeon training for the rest of 2026. Every other weekend, we do cadaver labs across the United States. And what we've had to do recently is Traditionally, we bring in the surgeons on a Friday, and we train on a Saturday morning. The demand is so high now that we have to do 2 sessions on Saturdays. And so starting with our Cadaver lab next week, we'll do a morning session and an afternoon session. Last year, how we manage the demand was we had 1 surgeon training on Friday and the other 1 on Saturday, but it was very difficult for surgeons to take the time out of the labs where they work every day. And so that's why we're doubling up now on Saturdays to meet that demand. But we have plenty of surgeons that are already trained to continue to drive the growth in I think what's more important is that we've doubled the number of VAC approvals in the last 3 months. And so we exited Q1 with 90 approvals across the United States. Now we have [indiscernible] VACs that are approved where we can sell. And I think the 123 ordering customers is important because then you can see this leading-edge indicator, we already have 180 approved and so we have 123 of those 180 that have ordered, which is 60% more than we had in Q1. And so as we look to Q3, we have a much different momentum than we had in any quarter so far. And this is what I like to remind everybody, this is it's new and it's early. And we're encouraged because these numbers demonstrate progress in adoption. If you look at the patient side, we've had almost 1,200 unique patients that have been identified by physicians, physicians like Dr. Huang and Dr. Jain, they've brought the physician the patients forward as candidates for hypoglossal nerve stimulation. So at failure patients. And of those 1,200 patients, we've had 900 consented into our Genio navigation system. This is important to our company because the Genio navigation system is unique to Nyxoah. And when a patient can sense into our navigation system, they are allowing us to manage their patient pathway. And the physician offices like Dr. Jain that we work with, love this because instead of their staff having to work through navigating the patient, the navigation center does that. And you can see that's a 62% increase over the first quarter. And then finally, and maybe most importantly, since we just came out of the reimbursement conversation. We have 427 patients in prior authorization which is a 77% increase quarter-over-quarter. And so when we look at looking -- predicting in the future of Q3, we're in a much stronger and a larger foundation than we did coming into Q2. And then finally, at the bottom, we did a backwards analysis over the first 6 months. So this doesn't include Q2. This is just in Q1. After Q1, the first 6 months, we had already accomplished a 15% market share in accounts where we had launched Genio since 2025. So these are objective measures. If we go to some subjective measures.

I will let you read for a second. Yes. No, no, because these are a lot of numbers. And you see here the excitement. So maybe in digesting this, let me also go back to how we started launching. So we started launching with a focused approach. We wanted to be in the high-volume [indiscernible] sites. We identified 400 in the U.S. At this moment, you see we're already at 180 where we can do actual treating patients or doing business. Scott started with 25 sales reps we added 15 in Q4. They were fully trained in Q1. So in Q2, we undergo 40 sales reps in a territory. And if you then see also all these numbers, I mean it's impressive. At least we are impressed what we are seeing and also the feedback we are getting from patients, from physicians, but also from the nursing staff, also incorporating a new technology into their daily business. It's truly impressive, and it gives us a lot of confidence. So I don't know, before we go to the next slide, if you have any questions on this because I do think it's important that the numbers are well read and interest rate. So if there are questions on this one, maybe it's a good time. David, I'm sure you have a question.

I believe there's difference we have the net revenue, whether it's different in gross and net. And when we back into what the number of procedures were in Q2 relative to the number of patients that were in or have been submitted for prior of exiting Q1 and it implied that you captured like 80% to 85% of those patients that exited Q1. Now we have the number for what the exit rate is in Q2 if you take that same 85% number, it puts you at a revenue dollar in Q2 that's higher than what consensus models today. So trying to get an understanding around maybe what the difference could be on the math, if it's net or gross. And whether or not it's fair to assume that, that capture rate of the exit prior office submissions is a fair number to on a go-forward basis or just as you scale it and should work its way down for us.

So it's a great question. The reason why it's hard for you to model and us is because since we're early in the launch, and we're getting new VACs and new accounts approved each month. And when we have 55% more patients identified by physicians just over Q1, it's hard to model it because we're getting traction and momentum. And so I appreciate -- and you're right, when you talk about 80% to 85% capture because prior authorization sometimes takes -- maybe it takes 1 or 2 weeks for approval, but then you have to go through the whole scheduling process. And so we'll have patients that have approval in Q1, but don't get scheduled until Q3. So there's always going to be some carry through the 427 number is a really conservative number, right, because that doesn't include patients that we might be carrying over, but it's hard for you to model because we're just gaining our momentum. And these -- the additional 15 reps that Olivier just referenced, they're just now opening new accounts. And so we're seeing a broader influx of patients. And so it's hard to model that. And then to the physician's point, we have accounts coming on now that have never worked with us that are high volume and they're starting at a high volume. But I think you're thinking about it the right way. It's just hard to give you a direct number because of the adoption of the therapy. Was there a question from the?

There was a question from live chat. You may have touched on this in your response, Scott. On average, what is the percentage of prior authorizations resulting in an effective implant? What is the average number of days between prior and effective implant?

Yes. So that's hard to model. What I will say is that we -- to this point, and the numbers are still small relative to Inspire, we have 100% approval rate on all of our prior authorizations. If it does get rejected, it gets through on appeal. Now the amount of time it takes to get scheduled is variable right now. And I can't speak to an average time because it's that broad and to give you an average, it would not be indicative of what the market is demonstrating .

But also in building a little bit further on this, what we have learned is that there is a direct correlation also by having feet on the street, yes, and also accelerating the opening of new accounts. I think the 98% growth is demonstrating this -- you also are aware that we recently also financed the company further. And I was always saying one of the key priorities in doing this is we would like to add more feet on the street. We would like to invest in U.S. commercialization. So with this, and maybe this is a primer as we like to say, Scott is already hiring the next cohort of salespeople that are directly the result of our recent financing. So we are accelerating this. We will be adding another 15 sales reps the hiring is ongoing. We do think that they will also show us an impact already in the last 2 months -- 2 or 3 months of this year and definitely setting us up in a stronger position also of Organ [indiscernible] 2027. I think we covered the questions on this slide. So Scott, maybe also go a little bit more into the patient experience is an experience that you are hearing from all the phases you're interacting with.

Yes. So moving from objective measures to subjective measures, if you will. We've outlined how this procedure and therapy is being responded to by physicians, health care providers and patients. And so on the surgery side, you heard it this morning from both of the physicians. Physicians want to offer options to their patients. . And what I've -- in the early days, there's a lot of physicians that have come to us and they've walked towards us wanting Genio because they want to be the experts in their marketplace. This 88% of providers commentary came from an external survey that was done where physician decision makers said that they prefer options for their patients, and that's nearly 90%. The DREAM study, and Jay is going to talk about our data but the DREAM study allowed for patients with positional OSA. Those patients are very difficult to treat. Positional OSA patients were completely excluded from the STAR trial by Inspire and they were excluded from the OSPREY trial by LivaNova. So 70% of the patients in Dream had a position of OSA. So they were difficult to treat, but we still achieved great results and that matters to surgeons and it matters to sleep providers. Finally, and this is probably the most important bullet of my time here with you today is the real-life experience. When these patients are activated, and physicians performing awake endoscopy they see an airway opening they've never seen before. So this isn't coming from me. This is coming from physicians. And they ask us, why is the airway opening so much higher and so much broader than what we've witnessed over the last 10 years. And it comes back to how bilateral stimulation works. And so we're actually spending a lot of time trying to help people understand the mechanism of action on why bilateral stimulation works the way it does because seeing is believing. And when physicians see this airway opening, they're blown away by how effective the therapy is regardless of the position that the patient sleeps. And then on the patient side, it's relatively intuitive. But aesthetically and cosmetically, we have seen younger patients and women in particular, who do not want to have a pacemaker and they don't want to have a lead tunnels up to their chin. But then also think about the technology itself. It's smart app based. And the MRI conditions for Genio are minimal, and they're unrivaled by any technology, not only in hypoglossal neuro simulation, but in most implantable products, our conditions are minimal. And then there's also this desire for patients for an implant for life. And that's because our activation ship is the brains to the operation. The average age of patients in all of these clinical studies was mid-50s. So these are young patients. And so they're going to have to think, how do I want to plan the rest of my life. And when we can take our activation ship and put it in its charger and have an update just like your phone, they don't have to have a replacement surgery to get the most current device available to them. And so -- these are subjective measures that give us confidence for Q3, in particular, but [indiscernible] for & Beyond. And to restate something I said on the last slide, we have surgeon training every other week, we have sleep program. We have a high demand for sleep trading programs, and we're oversubscribed for the rest of the year. So the challenge that we have is meeting the demand of new surgeons and new sleep providers who want to work with us.

So if there are no further questions for Scott on this one, I would propose a 5 minute break and then we work back with clinical data and looking forward on the market dynamics. Would that be okay? Can I just ask 5 minutes? Not make it 10, but please limit it to 5, and I see you back shortly. Thank you. [Break]

And we will continue with Part II. So part II, we will cover the clinical update. We have our Chief Science Officer, Jay Subroyen with us. We will talk about market dynamics with our Chief Strategy Officer, Ashley Mittelstand, and then we will talk about our financial update with our CFO, John Landry. So maybe can I call all 3? Jay, Ashley, John? So Jay, let's start with you. So we already talked a little bit about the results. We listened to the physician experience and also the complete concentric collapse patients were coming up. So okay, switch Yes. Okay. So from a clinical perspective, what can we -- is that thing, okay? Okay. From a clinical perspective Jay, what can we expect? .

Thank you, Olivier, for the question, and good morning. It's a pleasure to meet everyone here. So in terms of the clinical update, the best thing we can give at this point is a quick update on the progress that we are making on the CCC indication. Just as you can see, Genio is not currently approved. It's -- we have a warning, not a contraindication. But just to give you a little bit of background why CCC has been challenging and we have ENT surgeon sleep medicine physicians here. But it's the inward collapse of the circumferential inward collapse of the whole upper airway, right, like at the soft pilot level that makes it really, really difficult to treat this condition. Currently, there is no good evidence in long-term clinical -- high-quality clinical studies. Having said that, we are finishing -- the last of the patients followed for the ACCESS IDE study, which focused on hypoglossal lab stimulation disk case genio therapy for OSA patients. That's next week. We'll have data readout before the International Surgical Sleep Society meeting in October. I'm pretty confident like based on like some of the early data that we have seen in that sleep study, which was done in Australia about 5 years ago and also the early data that we are getting from the EU commercial uptake in the CCC patients that the data will be strong. We don't have any official data readout. But if you can see these numbers, these are some clinically significant improvement in these patients. Of course, like if you look at the European commercial data, it is small numbers, but about 67% improvement in a small patient group. And our plan remains the same. We will write this up and submit the PMA supplement, as Olivier alluded to in the past by Q4, and we are positive that this will result in some meaningful acceptance of the data from FDA.

Any questions on CCC and where we stand? David? No question on this one. No, because I think it's very important. We have been talking from the beginning when we looked at our bilateral stimulation effect or we completely differentiated. I think also our vision makes sleep simple. This is what we need also with making sleep simple, that when you are a patient and when you are a physician, you don't need to think is this patient, a CCC patient? Is it a non-CCC is sleeping on its side, on the back, all these things. So it's supporting also this mission. And Jay I mean already extremely strong words with you and the team. Sorry that you cannot disclose more, but I think everyone understands why on access. But from a timing perspective, time lines unchanged. [they remain the same. We submit Q4, and we expect also higher positive reply. And then by Q1, we could be adding this to the label in the U.S. to be very specific. Now next update, publications.

Yes. So the data is one thing, then the scientific dissemination of the data is equally important. What you see -- so there are 2 main themes if you look at this, right? Like one of them is there's a heavy focus on generating evidence for actually 3 main themes. On CCC, whether it's through clinical studies or real-world outcomes. That's one and more real-world outcomes, you just see 1 publication from single center at Marburg, but there is -- there are a couple more that are in works right now. And lastly, we've started trying to peel the -- try to understand the mechanism of action better. So let me walk you through real quick. On the left, we have all the publications that are currently being written up or -- it's an active review in a journal with a better sleep study that has data for both CCC and non-CCC that you saw real-world data that about 30 patients from Moberg in Germany by Professor Richard Berg that's currently in review. We just got feedback from the reviews last week. So we will have that addresses get published soon. Accepted soon rather. And the last one is on the left, it's the paddle design, right? Like we've developed a finite element model to understand what is the difference between paddle and other modalities of stimulation, what happens electrically within the NAV and why we are seeing the kind of outcomes that we are observing. So those things have all been written up there, either like I said, it's an active review or in the process of submission. And to the right, we did talk about the ACCESS study. We will write that up. At the same time, we'll finish the CSR and the PMA supplement, and that will go to a high-quality journal. And more importantly, now we are actively collecting around 30 patients right now by my count, real-world data on CCC patients. The idea here is like these real-world patients would have been followed up a lot longer than what we have in Access in case there is a question or a pushback comes from FDA we'll have data beyond 12 months showing really good outcomes in these patients. So the dissemination of the scientific evidence is just as important as generating them .

So ILS in LA will be very important as we'll have a lot of new numbers to disclose specifically on CCC patients. So also looking forward to seeing you there as well and updating you on this. Okay. Thank you for this update, stay with us. And we will move now to actually maybe actually a quick introduction on yourself as well before we jump into the market dynamics that we are currently facing in the U.S. .

So I'm Ashley Milstead, I'm the Chief Strategy Officer for Nyxoah. I've been working in med device for over 20 years now, launched quite a few products in the ENT space and other indications as well. And I've been with Nyxoah since 2023.

So tell us Ashley, actually what is happening in the market?

So I would say -- so I love this question. And even under the most conservative numbers, I would say we're still looking at a very large market, huge unmet need overall and underserved and underpenetrated. So all of those factors obviously play well. And with the cloud parting on the coding situation, I think there are some other drivers that we are really seeing play out well in the marketplace, especially for Genio. So when we look at what's happening right now, obviously, one of the bigger things within OSA is the expanding prevalence slow but sure in the United States, in particular, with the rising BMIs and then also the aging population. We're seeing quite a few women come into OSA. This bodes really well for Genio because there's high appeal among women, female patients based on the design of the device and where it sits. What we're also seeing now with GLP-1s because of our timing in the U.S. market, we didn't really see the major disruption that some others experience. And for us, right now, we're seeing it on a net diagnostic catalyst. It's been great for driving momentum, bringing people into the office and then obviously, with that, exploring new treatment options. So for us, obviously, we haven't been chasing BMI. We're looking for more interesting and complicated airway options. So that's, I think, been an interesting one for us and seeing that definitely as a tailwind. The other thing that we are looking forward to and have already been enjoying is HST reliability. And I say this from 2 perspectives. One is the sophistication of the devices, but also the coding clarity, that's come alongside those as well. So when we look at what's happening with HST, this is something that works well with a Genio pathway. We've leveraged that working with physicians and patients in working in HST as well as PSUs. So we are expecting that to continue to open the funnel for patients coming in, both for OSA diagnostics and for HGNS assessment. So that's been a wonderful driver and again, expecting that to continue in early 2027 with the coating there. The last one, which is the one I'm also so excited about from a patient-facing perspective is wearables adoption. So again, even with the most conservative estimates, we see a very large undiagnosed population in the U.S. and wearables can really unlock that for us. And for Genio, obviously, we have a wearables part of our solution, and these patients are predisposed to wearables. So for them, it's a much easier conversation and it's something that, again, we see as a major tailwind -- excuse me, major tailwind for Genio and for the market as a whole.

Before we move to the next slide, I would like to come back to one aspect, the GLP-1s. And why? Because I was facing again 100 questions myself on GLP-1s, but I want to link it actually to more ostrategic choice. And also, Jay, you can also share your thoughts on this. So it says Genio focus on complex airway openings. So we have cut off BMI 32. Strategically, Nyxoah always has chosen not to build evidence in going with BMIs and above to 40. Can you elaborate a little bit on why? And then also, of course, what is the impact on GLP-1 and why is really a kind of tailwind where sometimes for others, it can be perceived as a headwind, please.

So this is purely my clinical perspective and based on this. So there are a couple of reasons, right? Like when we're trying to power system externally with higher BMI, it becomes much more of an energy requirement. We can definitely reach if you really crack up the amplitude we can. And we do have anecdotal evidence, we can probably go up to 5.5% an impact. So we wanted to get into the market before we explore all of these opportunities. The biggest advantage of driver that I have seen, based on some of the conversations with the ENTs is despite the GLP-1 and weight loss and improvement in OSA, these patients still have significant residual disease, one, and now they are within the BMI range of our implant system. So it's actually a net positive that we have seen. And the other thing that we hear and some of the physicians here will agree to this, it's not a 1 solution for this OSA patients. It's probably going to be a combination therapy for these patients use GLP-1 bring their weight down and probably get them on Genio therapy, right? So that's something that we have seen that and again, all the conversations seem to lead to the fact that it will bring more patients within the treatment pool of Genio therapy that's currently indicated even without going to the BMI of 35 Do you want to add something? Sorry, there's one more aspect that we have to think about, right? GLP-1, the assay, it's a mechanical problem, right? Like the GLP-1 can reduce some wait for these patients, maybe they lose some bristle fat and whatnot, and they get overall healthy and their OSA symptoms may reduce but the mechanical construct of the airway is not going to change significantly. And that's one of the main reasons the racial disease burden for these patients will remain significant that warrants an additional treatment, in this case, a hypoglossal .

No, no, correct. And then just summarizing this. If you look at the overall therapy penetration still below 10%. We do think that it's so important that we can treat patients with successful clinical outcomes and that we can make sleep simple by also offering solutions when there are complex airway obstruction. I think that's where we differentiate. Just wanted to point this out. But actually -- how about you continue?

Yes. So just really briefly, in addition to what we hear from physicians every day, we did some double-blinded research, and we found, again, surgeons value the option of Genio as well as the Genio design. We are seeing very strong adoption intent, and we've been very specific with our targeting and we've been very successful with that targeting to date. We've seen a strong adoption ramp overall within the space, and we're also seeing evidence that our sleep strategy is absolutely on point. I think one of the things that I'm also excited to see as we hear from physicians and especially patients you talked before about the 20% to 25% of patients that refuse other HTS solutions because they don't want an implanted battery. But what I really like is how we're seeing that play out right now, what we're actually seeing from patients and physicians. And so I would say, at a really high level, uses some categories where we're seeing patients come into the pipeline that had turned down the therapy before or are now considering it. Number one is patients with aesthetic concerns. This is especially true within the female population, but also with men as well. a lot of patients decline surgery because they don't want to have the visible neck or test cars or they don't want a palpable IPG in the chest. So we've seen a surprising surge of patients that have come forward that have aesthetic concerns. Obviously, Genio is a great fit for those single incision in a discrete location. We're also seeing patients come forward from a work environment compatibility perspective. So if somebody is working in a setting where there's potentially interference with active electronics then this is a serious consideration for the career and we have seen patients come forward, example, nuclear facilities workers that are looking at Genio in particular because it's a passive implant. The other one is replacement procedure concerns. From a patient perspective, the very young or very old patients are looking at this as something that they'll have for their life. And so as they look at what choices they have, Genio was designed as an implant for life. So looking at those potential replacement procedures down the line has become a factor especially for the much younger, much older populations. So I think from a patient perspective, those are the 3 that are front and center. And when we say patients have declined for the battery design and other solutions, this is how they're coming forward. From the physician perspective, you talked about complete concentric collapse, and obviously, there's a lot of interest there, obviously, expecting to hear more at ISSS. The other one we hear a lot about is MRI conditionality. And though obviously, any patient needing a lot of MRI dependent care. We've got 3 torso, MRI conditional 3 [indiscernible] -- thank you. In the torso, and lastly, obviously, position-dependent OSA, Obviously, not affect with every patient, but it can compound the issues that patients are experiencing with their OSA and definitely a critical factor in the decision making for their care. .

Thank you. Maybe on this one because before we go into the financial section. So any questions so far on the way we look at the market dynamics, the positive view that we are having we see the market continue growing even double digit, but also Genio's unique profile by Ashley was highlighting because sometimes we tend to go only on how can we expand in a CCC population. But if you look at static concerns, for example, all these things that are really impacting and influencing patient choices. Any questions on the group on this one before we continue?

Yes. Maybe one when you think about like, I don't know, 5 years from now, when you think about the CCC versus the non-CDC patient population, would you expect if there's 100 implants that you have, that there would be a higher percentage of those total implants that are coming from the CCC patient population, meaning that market expansion is more of the piece behind longer-term Genio adoption or CCC is 30% of the addressable patients out there, would it be fair to assume that's a 70-30 split of versus C.

So Jay, feel free to fill in. But first of all, today, CCC is simply contraindicated for AGS unilateral stimulation. So just by offering these patients also in AGNS solution, it's already a large wind and it will also have a positive impact in increasing the patient pool because today, 25% to 30% of those CCC patients cannot be treated. That's question. I maybe answer on. Second thing to your question, we also have seen that there is a direct correlation between a BMI and CCC so we see the more that patients are being heavier, also, you see the more complex the airway openings are becoming. And to that one, that we're coming back to what we explained previously. So on one hand, bilateral stimulation clearly differentiated itself from unilateral in being effective in opening a more complex or complete concentric airway obstruction. And on the other hand, there is also the GLP-1 impact that is bringing down patients from a BMI 35 or higher into a segment, let's say, BMI around 30. So yes, that is the short answer. First of all, by treating something that cannot be treated today by unilateral stem and yes, by also offering a treatment option with patients where you have higher BMI. So that's our answer. Jay, if I'm regarding something, please.

No, actually, I would defer to now, and I want to certain perspective so...

Well, I would say, number one, generally speaking, physicians and payers don't love driving use nephedoscopy. And so assuming things work on positive CCC was no longer a 1 but actually indicated. I think it would be a big boost because it -- for physicians not have to worry about actually choosing this therapy to actually offer to their patients I'll defer obviously, to Dr. Huang, who also does his thoughts as well.

With CCC patients, I mean, obviously, I think we touched on it before. Obviously, it is, I guess, market expansion is the term you all use. I don't know. It is market expansion in terms of PDs people were not offered anything before other than maximum mandibular advancement surgically. . And so adding this is something that is definitely less invasive, less recovery time and good outcomes. And then, yes, to second what Mel said, it does have to do with the population of surgeons who do not want to do drug-induced sleep endoscopy just because it's not fit the efficiency of their practice pattern or the reimbursement that they would like to have from these outpatient endoscopic procedures. So that would open up the market or at least open up more surgeons probably perspective on wanting to adopt something like this in the practice. Thank you.

I hope this is answering the question. Any questions from the online audience. No? Okay. So then we can continue, and we will turn into more of the financial aspect. So John, thank you also for joining us on this one and also sharing your view on the part to profitability and of course, tolling the recent rates that we did.

No. Thank you very much, Olivier. For those of you don't know me, and I haven't had the pleasure of meeting, my name is John Landry. I'm the CFO here at Nyxoah. I joined in the fourth quarter of 2024. This is my third medical device company. I started my career public accounting and probably at the risk of dating myself, I started with Coopers & Lybrand before the Pricewaterhouse merger. And at that point, I audited mostly hospitals and manufacturing companies. And then when it moved away from public accounting, medical device was a very nice marriage of the combination of hospital health care and manufacturing. So it's a nice transition into the medical device space. I've been here for over 20 years now. third medical device company. The first 2 medical device companies I joined. We're in a very similar stage to Nyxoah when I joined the company. We had about $5 million in revenue in both of those companies, and we were fortunate enough to grow both of them up over $100 million. Still going strong today. So when I joined Nyxoah, I saw a lot of the hallmarks of those 2 companies in Nyxoah, very specifically, great technology and outstanding patient outcomes. And I think the combination of those factors will allow us as well to get to $100 million in an accelerated fashion. So one of the things -- turning now to the slides as we talk about the path to profitability. One of the things that Olivia and I talked an awful lot about is how do we get there and how do we get there quickly. And when you look at the path of profitability for us, the annualized revenue breakeven point for us is $150 million in revenue to get to breakeven. And what does that represent in terms of total market share. When you look at the total market share from an HCS perspective in the U.S., it's about 15%. So as you think about the 15% level, recall from a slide so ago from Scott, when we looked at the initial 6 months experience that we had in the U.S., we've seen about 15% in those accounts that we've seen to date already. And if you look at some of the commercial pilot experience that we had in Germany, going back a couple of years, within 18 to 24 months, we were also at 20% to 25% market share within an 18- to 24-month period of time. So when you look at that, that gives us confidence that we can achieve that revenue breakeven point within a relatively short period of time. Another key to this path to profitability is gross margin. We need to get our gross margin to scale at 80-plus percent, and we have a very defined pathway to get there with 2 key drivers. One is our Genio 2.2 device. That Genio 2.2 device will have a new activation chip as well as a new disposable patch. Both of these are redesigned for patient comfort first and then also to reduce the cost of the device dramatically. We're going to take about 80 -- sorry, 90% of the total cost of that disposable out of the cost of the product overall which will allow us to step function our gross margins from the low 60s to low 70s when we roll that out in the first half of 2027. Additionally, another key driver is around our volume discounting. So we have a contract manufacturing agreement with a manufacturing firm here in the U.S., and we have predefined volume-based price points in that contract. So as we drive volume through the contract manufacturing firm, we'll see another step-up in gross margin to get into the low 80% range. So those are 2 very key drivers that will get us there. They're very defined. They're very tangible, and we have pathways to go out and execute upon both of those within this time frame. Another item on the bottom left hand of the screen is our annualized cash operating expenses. So we want to maintain tight financial OpEx discipline throughout the organization. And what we've done a couple of things. One is we've taken a look at our operational expenses and then redeployed operating expenses from parts of the business that we needed to grow and scale in order to get to commercial launch. We've now that those projects are done and behind us, we've redeployed that capital to our U.S. commercial organization to help grow the business faster. We're going to continue to do that and redeploy capital from parts of the business where we can leverage what's been built and then go drive that into faster growth. And that will allow us to grow our operating expenses at a modest rate, kind of mid-single-digit rate on an annual basis while allowing us to go out and expand the U.S. sales force and drive additional top line growth. So again, tight cash OpEx management will be a key to getting to that path to profitability. And then the last, as Olivier mentioned, the financing very glad to have that behind us and get that done. And a special thanks to our Board member investors who participated in the financing. -- the existing investors who invested in the round, and we welcome new investors who came into the capital structure. It's a great show of support for our organization, for our technology and our opportunity that lays that we have out that's laid out in front of us and very happy to have that behind us, and that gives us the cash to get to profitability and to get to cash flow positive. So that's very important because that allows us to go out and focus on the business, focus on executing our strategy and building a very strong business here that's profitable and can continue to scale. So that's path to profitability. The next slide that you see up here is just a graphical depiction of what that looks like, and it compares and contrast 2 things. One, it compares and contrast our 2026 guidance as laid out from a revenue, gross margin, cash OpEx perspective and the operating result and then what you see in the pale colored bar graph side of the chart, then you have the teal colors which represent what this path to profitability looks like at $150 million of revenue with an 80% gross margin and OpEx of $105 million. You can see that we go from a negative operating result to a positive operating result at that level. And one of the keys there is, again, gross margin and the OpEx and managing our OpEx to be able to drive continued growth and knock that operating result in the opposite direction. A key element is that you'll start to see in our financial statements as we publish on a quarterly basis is our cash burn will start to come down. So for the first quarter of 2026, we had cash burn of approximately EUR 22 million with the cash balance that we presented here in the release, if you adjust for the cash that we raised, our cash burn was about EUR 19 million. And I would expect to see that continue to decrease quarter after quarter by roughly EUR 2 million to EUR 3 million per quarter until we get to breakeven and then positive thereafter. So this is really something near and dear our heart. We want to get there because we want to be a self-sustaining business. And we want to make sure that we can use the capital efficiently to drive top line growth and maximize the value of the organization, essentially sense will be based on multiples of revenue here until we reach that profitability stage. So those are the metrics that we have here on the path to profitability pathway. And then now turning to the next slide, you can see, I think we touched upon some of these.

I'm not pushing -- I want to pause for the set. No, no, because I know this 1 and with some of you, we had also some interactions, some discussion on this. So I want to ask questions on this part because we can explain this -- but on the other hand, you also need to believe what we are explaining and to feel to us behind this plan. So I think it's a good moment to have this conversation since we are here together. So any questions on this part to profitability?

Yes. I guess I'll ask one.

Yes, please. .

I feel like when we look at other similar stage medical device comes for the past several years now that profitability or breakeven level had at $300 million, $400 million, $500 million in sales, right? I mean, $150 million, of course, is a lot sooner than at least what we have seen in the past. So I guess what gives you the confidence that the level of spend that you expect at the year in which you get to $150 million relative to that number, we'll still be able to support growth on a go-forward basis and it is kind of the right number?

Sure. A couple of things, David. One, I think as we take a look at the strategy that we deployed and targeting the top 400 accounts in the U.S. that allows us to be capital efficient with our sales organization and going into those accounts where the top 400 accounts represent 70% to 75% of the total HTS opportunity. So by being concentrated in those accounts that again allows us to be capital efficient in that regard. And then the second area will be capital efficient is in regard to DTC spending. So when we look at our competitor, they spent a significant amount of capital in terms of drawing people and patients to the top end of the funnel and they did an outstanding job of making HC&S awareness grow over time. which we'll now be able to capitalize upon. And based upon some of the early lessons that we've learned in Germany and in Europe in terms of how to manage that DTC channel and how to make every dollar count and be optimal and efficient in that regard. That will allow us to drive the patients in the top end of the funnel, allow us to generate that growth and do so in a way that's economically efficient to allow us to get to that breakeven point faster than our competitor did. So that's how we're thinking about that.

And I think maybe in addition to this as well, sometimes it's nice to be second to the market. And what I'm trying to do this is that you can accelerate, you can go much faster take, for example, the reimbursement aspect that we covered. We just launched a technology. We have reimbursement in place. We got a good payment. It took inspire 5 years. get to a point where they had coverage from a decent amount of payers in the U.S. to start generating revenue. So I do think if you follow the calculation that the calculation as such makes perfect sense in the modeling, it's more about the time frame. How fast can we get there? And we touched on the and seems to be a kind of magical market share number. But why is this 15% so important? If you look 2026, the projections or the growth -- the revenue expectations for AGLS are between EUR 850 million to EUR 875 million. And going forward next year, I do think we will be touching EUR 1 billion. And if you are touching EUR 1 billion and you want to have EUR 150 million to get breakeven, it corresponds with a market share percentage where we today or feeling confident listening to Scott seeing how we are ramping up and seeing also the excitement with physicians and with patients that we are capturing. But again, how do you say this -- the proof is in the eating of the pudding or in the pudding, it's something with a pudding. So I just think by showing continued execution delivering quarter after quarter and ramping up that will be the best way also moving forward to convince everyone that we can reach this point pretty fast. There is one question coming from...

Yes, one from the chat. Some analysts note that to reach breakeven Nyxoah would need to capture 40% of the incremental HGS market. Do you agree with this?

I will let John answer, but I will say, no, I don't agree with this, but please be no, you will understand in a second.

Sure. I think there's a couple of different ways of looking at it. One way to look at it would be to say, okay, there's a current market now and then you need to capture an additional growth, which would be the 40% calculation or how we think about it is we're going into existing accounts. We're going into existing books of business across the U.S. Again, very focused on the top 400 accounts. And as we think about gaining market share, we're going to gain market share in those accounts very specifically, and we're not going to be looking at the growth in the market overall. So for us, that's how we're calculating the 15% market share opportunity as the baseline for our revenue target here of $150 million of revenue.

Yes. And that's exactly what we are seeing today. The patients we are capturing, the ones that Dr. Huang and Dr. Jain were referring to, those are patients that normally would get the inspiring plant today there in the in implant. So it's not our success will not be defined from the new incremental patients and how strong we are there, it will be defined from the total patient population that gets an AGNs implant. So that's why I was saying no. .

Footprint expands rapidly. Do you expect future revenue growth over the next several quarters to be driven primarily by opening new accounts or by increasing implant volumes within your existing mature accounts.

So I will take this one. I know that Scott is also having an opinion on that one. It will be a combination. As it will be a combination. But Scott, maybe you want to elaborate a little bit more on you think will be the acceleration short term and how this will

It's clear it's going to be from the initial hires because there's a 6- to 12-month start-up time that's not going to change. We still have to get into new vacs. We still have to train new surgeons. And so the growth is going to accelerate from the accounts that we've already penetrated because we've built a referral pathway in those accounts. We've built comfort with the surgeons in those accounts. and they're seeing great results with their patients. And so the referral rates are accelerating for Genio from the referral in existing accounts. And so our initial cohort of hires have really, what I call, walked through the desert of getting us to this point of proving the concept to U.S. physicians and they're adopting it at a high rate. We still need to scale soon because we have to get those reps deployed so they can start the VAC process and start the surgeon training in the new accounts. But it's a great question. The bulk of our growth and acceleration is going to come from the people who have been here the longest.

Perfect. And last one from the chat. You reported 180 active high-volume U.S. accounts and 427 patients in the prior auth process. Beyond these encouraging leading indicators which operational KPI should investors monitor to assess whether these accounts are successfully ramping towards mature productivity.

So I like the leading indicators that we presented, and there was a question earlier about how can you map forward the prior ops in particular? What percentage of those can you map forward I think that's the primary indicator for us is who's in prior authorization and how quickly can they be scheduled. And because it is still very early for us, that is a moving target. And so but what I'll be focused on moving forward is exactly what I presented today.

Okay. Thank you. So then John.

We have a question here. So I just wanted to follow up again quickly on the $150 million. It's kind of 2 questions. I think on the prior slide, it said that it was predicated on an assumption for 15% market share. I know in Germany, where it's obviously a duopoly. I think Genio has hovered around 15%, 20% market share. And I think earlier today, you said that in totality U.S. centers where Geno is being implanted it's been 15% share. There's another competitor supposed to come to market in the coming call it, 6 months plus. But is your assumption for 15% share that when they come in, the share of the market would be entirely out of Inspired be able to the 15%? Or how do you see those dynamics working out as it relates to this?

Yes, it's a good question. I think from our perspective, we expect to gain market share and still be at the 15% level in these accounts and continue to growing. Another factor that as we look back at the German experience, the German experience before we entered into the market when it was just a monopoly, the business was growing roughly below double digits in terms of growth percentage on an annual basis than when we entered the market, the growth rate in the overall H&S market moved to like the 25%, 30% range. So with more players in the market, we'd expect to see growth increase as well. And we expect, based upon the results that we're seeing and the patient outcomes, we would expect to see that market share for us continue to be there and continue to grow over time.

And then maybe in addition to this as well, so we also showed that the current AGS penetration is not even reaching 10% so it's a huge pipe. And we do think, to John's point, when you have no monopoly, you go to duopoly. That is a turf company coming that this will only help drive more and faster market growth for Asia. That's one aspect. Second, we have the tailwind from the GLP-1s, where we also see that the awareness increase more over a patients. But maybe just focusing a little bit on AGS, and on LivaNova so that since this is touched as well, from a technology perspective, this is another pacemaker solution, where Genio is totally differentiated and that's also how we position. So we do think that within the pacemaker solution, there will be a competition between both companies where we see Genio has more unique totally differentiated approach. But to answer your question, we want to capture 15% market share of AGNS as a total.

Okay. Great. And then if I can just sneak in 1 follow-up. I believe you said, John, that -- and I'll give this question to shot. I don't think there's been a firm obviously time line on this $150 million but based on what you said, $2 million to $3 million reduction in OpEx per quarter, I think if I'm just doing back of the envelope methods to get to the breakeven point would be 7 or 8 quarters, call like at the midpoint of that range. Does that sound reasonable for your expectations? .

Yes. So just -- yes, just a quick clarification. The $2 million to $3 million is a reduction in cash burn, not cash OpEx so cash burn. So yes, so we'd see that -- that's in the near term. So we're talking like '26 type of time frame. As we see '27, they'll probably grow that reduction in cash burn as our revenue growth grows. So we'll see that reduce. So in terms of that time frame, certainly not going to provide guidance as to when we're going to be at the $150 million today. But in terms of timing, it's not too unrealistic from a calculation perspective, as you discussed.

Yes. I have a question related to both market growth side of things, but I want to come at it in a little bit different way. Not to put words in your mouth, but it seems like at least for the next couple of years while you're a little more capital constrained you are really focused on taking share rather than investing in a way that the market leader may be in growing the overall pie. So I'm curious if that calculation changes at all, not only once you cross over into being cash flow neutral and so you're a little bit less capital constrained. But also if Inspire reimbursement does become decoupled from yours, is there a concern at some point that the differences in procedure and differences in reimbursement becomes so stark that you have to start doing market building of your own. And then also once [indiscernible] comes into the market, just how you think about all those different dynamics and how much you as a company need to invest in growing the top of the funnel versus the more targets .

Yes. So I think from my perspective, what we want to do is when I get to profitability because at that point, then we have control of our own destiny. And while we're managing our operating expenses tightly. We're also investing for continuous growth. And the investments that we're making today are going to allow us to have continuous cycles of growth beyond the point of profitability through new technology introductions through clinical differentiation. Those will allow us to separate ourselves in the marketplace and allow us to have those next legs of growth and provide that engine to continue to grow at a larger than typical rate going forward. So that's how we're thinking about it. The investments that we're making today, we're not cutting those out. We're planting the seeds for future growth, and we'll continue to do so and drive going forward. So that's how we're thinking about it. in terms of some of the items that we're looking at. Wearables is something that is key item incorporating artificial intelligence as well, having smart technology built into the device to help improve the patient outcomes even further and differentiate even further. That will allow us to continue to gain market share, allow us to continue to grow our business and can have those continuous cycles of growth once we get to that breakeven point. And at that point, I think our philosophy is we don't want to take the cash and take the profits and just build buildings or invest in non-revenue growth-generating opportunities. We want to continue to invest in innovation and clinical and people to go drive the business further and drive further adoption of our technology. I think we have a nice pathway to do so.

No practical applications of this that we discussed today as well. If you look at -- you ask about traditional market development or market growth drivers. We haven't presented the access data. But if you look at the percentage of patients that have CCC, that alone has the potential of growing the market more than our competitor can grow it through advertising, number one. Number two, through what Dr. Jane offered earlier today, these options, and it's not just Genio, there's options across the sleep space are naturally bringing more patients into sleep physicians already. And so I would argue that with the technology that we already have and the clinical data that we already have, we have the potential to grow the market. higher and faster than our competitor and the fact that there's an explosion in the sleep space of interest in options that patients are already coming in.

Since we all want to say something on this, and we're all saying more or less the same thing also from a business rule perspective. We are giving a guidance for '26, reaching EUR 36 million to EUR 40 million. If you look at the competition, they are at EUR 850 million. So I think it's obvious also that they play that role and invest more than we are doing just ending. That is one aspect. Second thing, we broke a monopoly please let's not forget this. We broke a monopoly, and we provided optionality. So we trust the physician will make the correct choice what patient will benefit best from what therapy and in a market that is so penetrated or so many patients. I mean only this will already give a lot of tailwind and growing before we're even thinking and investing in a specific type of patient that we would only own. So that's the second aspect. And then to Scott's point, with our technology differentiation take CCC, I do think that is a huge expansion of the pooling going forward. So if you combine all those things, we are the challenger. We are entering the market. We are completely differentiated -- and we also see that we can enlarge patient pool already in the CCC indication. So I think in I hope this is answering your question.

One more question from the live chat. Could you explain the slight difference between the 22% sequential growth achieved in quarter 2 and the 25% to 30% sequential growth you had guided for.

Yes, we can. And it's a little bit, how do you say this, a silly explanation. I'll have to give and then I had a question yesterday even before as well. So I will give you an honest answer what happened. So we are still a scaling company. We received our last order, and I'm looking at Scott on June 30. And unfortunately, there were not 31 days in June, it's worth 30 days. And as a small company, there is a person who need to pick the product that is a person who needs to ship the product before we can recognize the revenue. And we were not able to do this last order in a timely manner. I mean it sounds like a bus reason, if I can say this, but this is what actually happened. And if we would have converted that order, we would be at 27% growth. Today, we're at 22%. Yes, that's what it is. Will it happen again? No. But it happened, and that's where we are. But I hope also when you look at the leading indicators and how healthy the business is that this will not be the argument that will be the key takeaway of this Investor Day. But at least that's the honest answer. John?

Okay. So we just touched upon the preliminary results for the second quarter. So you can see our revenue for the second quarter at EUR 7.7 million, EUR 5.2 million of which came from the U.S. and mentioned quarter-over-quarter growth. We had $2.5 million in our international business. Our international business continues to grow nicely as does our U.S. revenue on a sequential quarter-over-quarter basis. So when we look at this year-over-year for the first half of 2026, we booked about EUR 14.1 million of revenue. That compares to about EUR 2.4 million in the first half of 2025. So we almost have fivefold increase in terms of what we've been able to do in terms of growing the business on a year-over-year basis. So that's an outstanding outcome and testament to both our U.S. international sales reposition we're driving growth on a worldwide basis. So as we look at full year 2026, we are continuing to reiterate our guidance for the full year of EUR 36 million to EUR 4 million for the full year. And with the delta, the 22% to 25% as Olivier explained, we have orders in hand, product out the door. So we're confident in that number. Now while as some people have pointed out, that provides us with a little more we need to deliver more growth in the back half of the year because of the second quarter result. We're very confident that we have the orders, we have the pipeline. We have the backlog to be able to do that. And very specifically, when I speak of backlog, I'm thinking about those number of patients that are in the preauthorization process, the 427 patients are preauthorization that grew 77% in the second quarter versus the first quarter. So from my perspective, I feel very comfortable that we have play in place. We have the patients in the funnel in the preauthorization phase that will allow us to generate that revenue growth in the back half of the year. that we've outlined with this guidance here. And again, our preliminary cash balance was $98 million. And again, thank you to our existing investors, new investors and our Board members who participate in the round. So I think that brings us to a conclusion on the financial slides. I'll turn it back over to Oliver.

No, no, it does. And then John, you also set it up for a nice bridging in going forward because we are almost reaching the end of the Investor Day. There are 2 more topics that are coming. It's the value creation aspect. And today, we have the pleasure of having the founder of the company, but also the current Chairman of the company, but also the single largest investor of the company an investment of ownership in our company with us today. And it's a pleasure to have Robert also. We will explain his vision and also in how we see value creation. And then the last slide will be for me and then also talking about the vision and the mission going forward. So, Robert?

Yes. I'm Robert Taub, indeed, the Founder and the Chairman of the company. And I can say for sure that I am the most senior person in this room. I'm a serial entrepreneur. In Belgium. I've lived in New York for a while also, and I have more than half a century of experience in health care. So we have managed -- it wasn't so easy but we managed to put together this capital increase and we have reduced the OpEx together with John and Olivier, we worked a lot on that in order to achieve or to reach all the figures that you have seen, so I'm not going to repeat all of that. But yes, the whole thing is about value creation. And right now, our focus is on the U.S. commercial execution and that we want to be the leader in ACS in the United States, well, actually, also in Europe. Clearly, there is a huge challenge for the company in general to recreate the trust that we have lost with the Street. It's clear. And this is not going to be done easily, but we will execute quarter-by-quarter our 25% growth or more. And it will take many quarters in order to recreate this trust, but we will be there. And at the same time, we will continue to look very carefully at our OpEx in order to manage if you want the cash that we have and that we will never have to raise money again. Because this was a painful, obviously, a very painful exercise last time. And however, by managing this cash, we also have to remain innovative because focus is, of course, Scott to deliver this quarter 1 quarter after the other. But on the other hand, we also have to maintain our leadership in innovation. Now I have to say that -- there's a lot of technology that is available in the company, which has not been exploited yet. And even in the activation ship. And so because all of this can be developed and is even available in the active agency but not used at this stage. And so these are some of the things that we will be able to develop without too much money in the wearables and -- but we're also looking at, of course, other technologies, but we will be very, very tight on the cash. So focus for the next 18 months is the launch. And to quote a bank that has shown us some statistics, we have Nyxoah is in a perfect situation. I mean the total addressable market remains huge. As you know, only in the United States, you have 500,000 new patients eligible for every year. So the total addressable market is us continues to grow. We have gross margin, as John has explained at the moment, we do not have yet this 80%, but we will get there, and we know how to get to 80%. And the growth in general will be quarter-by-quarter. And if we compare this to the 150-odd medtech listed companies there's only about a handful of them, maybe a little more than a handful that will meet all of these 3 criteria: gross margin above 80%, a total addressable market I'm talking about med tech company, but also some hybrid companies that are -- and this is -- and of course, the growth -- the annual growth, which we will be exceeding at least in the first 3 to 4 years. So if you want, that is the way I see value creation now will not avoid, of course, speaking about the CEO transition because that has been, of course, a question that has as et cetera, et cetera. Yes, I mean, the growth of the company and the success of this company will be in the United States, and we made a decision together with Olivier that we will have U.S. CEO and a U.S.-based CEO but also as an American CEO. And we started the search only Five weeks ago or 4 weeks ago. So it's going to take still some time, but everything is set up that by, let's say, latest the end of the year, we will have a new CEO possibly earlier, we're using, of course, a headhunter. And that's international, what I wanted to tell you. And of course, I'm open to questions, but I'm I invested quite a bit in the company from the very beginning, and I continue to believe that we will get there. Any questions? Olivier, go back to you.

No questions. So thank you, Robert. And please stay with us because we will -- I will do my closing slide. And then we will open it up the last time for the entire management also for our questions, if there should be any. No, I think you have today a lot of interesting presentations different perspectives from physicians all the way to reimbursement experts also to the company view. . So when I talked about tailwinds, we're talking about structural tailwinds for the obstructive sleep on business in general. I mean, it's a quick recapitulation. The addressable market under penetrated Robert was just mentioning 500,000 eligible to treat patients in the U.S. alone. I mean, today, more or less 40,000 or getting treatment. If you look at the GLP-1, a lot of work have been discussed on GLP-1s, I think by now, you understand our view. We see this as a catalyst. And we also know that it will drive more patients, it will increase awareness. Reimbursement Joe and Carla, thank you for providing further clarity. I hope that the dust has been as settled, as they say in the U.S. on this reimbursement. There is reimbursement. There is a coding, Yes, there is an evolution, but there is no reason to be thinking or considering that we would be out of reimbursement. On the contrary, with the latest CMS proposal, I think it's even more beneficial. Optionality also to as this market research that was done 88% of providers, and that's physicians, both sleep as ELT services, they want to have an option to choose. There is not such a thing as one technology that fits everything and everyone. So we broke this monopoly. And also we are seeing in the commercial results in the U.S. that this is all the right way and that we are really well embraced by physicians as we are by patients. Now in going forward, our vision, so one OSA ecosystem, I like to use the bus world of ecosystem because I do think today, OSA is part of chronical disease management, it's not something that you do. And then 6 months later, I'm cured. No, you're not cured. You have to stay disciplined. You have to stay compliant with your technology going forward. And when it comes to compliance, we're always talking about patients. you can have the best technology ever if a patient is not using the technology, it's useless as simple as this. And we do believe we gene that we are the best positioned company. We have a smart wearable we will be investing short term and making everything cloud based. So when you do cloud-based, you also do clearly monitoring. You will have physicians that can see how are my patients doing that can also act up on this. But you also have patients that will get live feedback on their sleep quality. And having a go. I think some people are wearing an origin. Also in going forward, we see how important it is today. People want to control their health. They want to know how did I sleep, -- how is this impacting my life. So with Genio, I do think, and I hope you agree with me, we are the best-placed company today that can make this difference. When it comes to the implantable stimulator. Also there, we touched about a single incision, the MRI compatibility that designed for forward compatibility. So also there, we are unique. Nobody else can offer the same thing. Sometimes it's nice to say this, but that's exactly what it is. And then in going forward, also what can you expect from Genio. So as we are growing, we are capturing data I mean, today, there is something called AI, ChatGPT, Cloud, whatever of the names. But these things, if they are well used they will help us accelerating, getting even better in providing feedback in developing cost economic effectiveness data. So also this we are integrating -- and then there was a question, I think it must have been from David since he's asking 90% of the questions. But no, David, sorry for the joke. But also, what do you expect in 5 years from now? You know what we expect in 5 years is that when you are suffering from OSA, you don't feel like a patient. You go to sleep, the system will detect that you are sleeping and activate itself. The system will automatically adjust stimulation just in what you need to have a good night rest with your airway remaining open. It will be a self-learning system. And when you wake up in the morning, you get all the feedback that you are waiting for on quality, on oxygen desaturation on hypoxic burden and we will also measure and make sure that all these data are incorporated and show the payers how much profit, if I can use this, or how much less they will be spending by an optimal management of an obstructive sleep apnea patient. That's what we stand for. Those are the last words of this investor meeting. Thank you again for being here. Looking forward to continue interacting more in going forward and looking forward to show you not only 25% because next quarter I think we will be showing 35% to 45%. So I do think we will have to accelerate even further, but also there, we think we're in a good position. Thank you, and let me invite you also for a light lunch because you know there is a relation with BMI and OSA so light lunch. Thank you.

That concludes the Nyxoah Investor Day presentation. Thank you for your participation. You may now disconnect your lines.