Good morning and thank you for attending the NYXOA Investor Day presentation. My name is Elisa and I'll be your moderator for today's call. All lines will be muted during the presentation portion of the call with an opportunity for questions and answers throughout the presentation. If you would like to ask a question, please press, please via text, excuse me. You may do so by pressing the QA button at the bottom of your screen. I would now like to pass the conference over to our host Olivier Tillman, CEO of NYXOA. You may proceed.

Niksova, because as you most likely all have seen, we yesterday published our Q1 preliminary numbers and I can tell you there is a lot of excitement inside of the company and we will walk you through all of the details during the day. If we go through the agenda, as you can see it's quite a busy agenda and we also hope that we will be able to provide you with a lot of insights on where we stand but also most important on where we are going and what you can expect. We will start by having some of our leading physicians talking about their experience. Afterwards we will address the hot potato in hipoglossal nerve stimulation reimbursement also there we were able to have an expert panel in the US reimbursement experts the JD Lyman group then we will focus a little bit more about NYXOA and where we stand how do we see the market dynamics because there is also a lot of activity recently going on impacting AGNS we will provide you with a clinical update more specific around CCC and then of course we will also share our thoughts on how we see becoming a profitable and leading company in the u.s we have our chairman with us today as well who will talk a little bit about value creation and then at the end i will wrap it up by talking about our mission and our vision and the innovation and how we are and will be leading in going forward that's in a nutshell the coming two hours after every session there will be a q a i think it's better to be a little bit interactive and not having to wait for two hours to order to to ask your questions so with this i will not take it any longer and i will invite already your chief medical officer dr mo boone together with dr wong and dr jane to share their physician experience so please so maybe let us start by a quick introduction and i think it's maybe best that everyone introduces

himself so dr jane can i ask you for a quick introduction absolutely uh so thanks for having me i'm dr vikas jane i'm the owner and founder of dream sleep medicine in frisco texas A large part of what we do is we manage a wide spectrum of sleep disorders, but particularly manage a lot of patients with obstructive sleep apnea, and help them manage and navigate through all of the different treatment options that exist. We have a very large panel of HGNS patients under management, and I appreciate you having me here.

Thanks for making time for us. Dr. Huang.

Hi, I'm Andrew Huang. I'm the former director of sleep surgery and the Positive Airway Pressure Alternatives Clinic at Baylor College of Medicine in Houston, Texas. As of this week, transitioned to the largest sleep medicine practice in Houston to direct their hypobasal nerve stimulation program. And Dr. Boone.

And I'm Mauriz Boone. I'm an otolaryngologist and sleep medicine physician by background. I joined NICSOA in 2024 as chief medical officer after an extended career in academic medicine at Thomas Jefferson University Hospital in Philadelphia, specifically focusing primarily on treating up short sleep apnea and using alternative treatments to help those patients. So just as a little additional background, both Dr. Jain and Dr. Huang have extensive experience in actually using hypogalcine nerve stimulation. Dr. Jain was the first physician in the country to commercially activate a patient, And Dr. Huang has the most extensive surgical experience having implanted 22 patients with Genio since we had our FDA approval the last year. And so it's an honor to be with you here both. Thank you for being here. I'll pose the first question to you, Dr. Jain. When you look at all the treatment options that are available, why actually use hypoglossal nerve stimulation therapy at all?

Yeah, absolutely. So for me, I think, you know, why add this therapy to our repertoire? who are, I think, in the past, largely treating sleep apnea has been a binary decision. You either got a CPAP or you didn't, and those were the only two options that you had. By adding this as an option for patients, we've been able to really personalize treatments. For patients, we've seen an increasing number of consultations that come in week over week, month over month, because patients are now understanding that they have more than one option to treat this condition.

Dr. Huang, given all the experience you've had thus far, what has really been your experience with the therapy on the platform?

I mean, this therapy is the most different hypoglossal nerve stimulation procedure that we have available right now, especially comparatively to INSPIRE procedure, which we have the most experience with. We started our program at INSPIRE in 2019, obviously just this past year with Genio, and so the approach, completely different. the bilateral stimulation equally different so I think having a new approach having the ability to target both hypoglossal nerves has made the platform for me very differentiated so that our patients have better options hopefully better therapy and it takes it takes a lot of kind of support from the company which is which has been great to help develop this this program for us So you have served as both a surgeon and a proctor.

What's been your experience with the surgical learning curve? And as a proctor, what's been your experience in actually how quickly physicians can actually incorporate this and become proficient?

Yeah, that's a great question. I mean, as a surgeon, I mean, I've been in practice for 11 years. It's pretty rare to come across a new procedure. And so I think some surgeons gravitate to that. Some surgeons are averse to that. This is a new procedure. You know, it is hypoglossal nerve stimulation like INSPIRE, but it's bilateral. The approach is completely different. The way the stimulation is delivered is different. And so for me, I gravitate to new procedures. I always kind of compare it to how it was obviously to INSPIRE. I have to say that it was a good learning curve for me. It was nice to have Mal there as my proctor to help me get through the procedure. but when I looked at it in terms of timing, my first procedure for Genio actually was pretty similar to my first procedure for Inspire back in 2019. And then as a proctor, I've been pretty surprised and impressed with the community of ENTs that I've helped, all having good timing with the surgery, you know, obviously having to go through that comprehension of this new approach, but I think as ENTs we're all, or at least the ones going to this, are up to the challenge.

Yeah, would certainly echo that as a proctor i've certainly seen that people have been able to adopt this and really incorporate this and become proficient very quickly uh to both of you i'm going to pose the question now um what clinical outcomes have you observed both objectively and subjectively and would you be willing to share a patient's story that you've experienced okay yeah i mean i think uh for us uh i think you know our practice is largely focused both on on objective and subjective outcomes.

So I think in terms of objective outcomes, obviously we're looking at, is there improvements in the AHI? Is there improvements in hypoxic burden? But I've also largely been interested in, is this gonna fit your lifestyle and the way that you live? So for me, the patient that really stands out with Genio is sort of the one that I would say might be, you might consider atypical. She was a compliant CPAP user, but she was recently divorced. She travels the world as an executive, and she was like, you know, CPAP works for me, but it just doesn't fit with the lifestyle that I want to live. And so after we discussed options, she chose Genio. And so what was great was that she not only just, you know, we saw a robust reduction in AHI and improvement in her sleep apnea, but it was just the comments that, like, she was able to be more confident when she traveled. She was more confident in relationships.

She felt more refreshed daily. and so those are the outcomes we're really after you know not just does the therapy work but does the therapy align with the lifestyle that the patient wants to live yeah i'll look at it more globally you know we've implanted 22 patients right now i would say all of them are candidates for both inspire or or genio and so really it's how that differentiated approach is and why patients choose it so for me the patients that ultimately choose genio over something like INSPIRE are because of not requiring a second chest incision, you know, better MRI conditionality. My most recent patient we implanted is a United Flight attendant and he didn't want to have to go through having the IPG through the imaging every time, which can be a little bit more of a hassle and so there's different reasons that they're doing it. Ultimately the outcomes we've been getting are equal or better to INSPIRE, and so I've been very happy with that as a total platform.

And so to both of you, I'll also pose the question, as your experience has grown with the therapy, are there specific patients you consider particularly suited for Gineo, and how is the actual process of selection evolved in your practices?

Yeah, I think for us, I think twofold. One is we certainly look at patients who are having trouble using CPAP, so I always find that the best alternative therapy patient is someone who uses their CPAP every night but can only use it for three and a half hours. So they're clearly compliant with therapy. They're just not able to use that therapy well. I think we've moved a bit away from, obviously we want to make sure that patients meet the eligibility criteria, but really we're looking more at, you know, do you understand what this treatment is, how to use it, will it align with your daily life? You know, we offer all of these options to every patient at consultation so they're aware of Genio as an option.

I'm a surgeon. Everybody gets surgery. I'm just kidding. Not everybody gets surgery. Now, when it comes to how I discuss this with patients, it's all about giving them the options. You know, we have data on both devices, present the data very objectively, and then you have to also then describe the other factors objectively. It's not all just about AHI, it's about usability, it's about lifestyle. So, when it comes to Genio, at least what, like I said, differentiates us and our patients that have chosen it has to do with just, you know, not requiring that incision, the MRI conditionality. Those are two big things that causes people to really gravitate towards it.

Great. So, again, to both of you, how do you actually see Genio evolving in your practice in terms of, you know, the future, et cetera, and how you incorporate it, and how you'll...

Yeah, I mean, again, I think for us, you know, for me, there's 80 million people who are still undiagnosed with sleep apnea. In my experience, most patients don't come to my office because they're worried that they're going to get a CPAP machine. So where we've seen this really evolve is by having treatment options for patients, they're more willing to come in. we're seeing as the treatment landscape continues to evolve more patients are coming in what you know and it doesn't matter for which treatment it's just more patients are entering the pipeline they're getting diagnosed with obstructive sleep apnea and then they're looking for solutions for it so so this is great to add you know to our toolbox yeah I think it's an evolving cadence you know and how this gets adopted in different people's practice I can think from my personal opinion, the cadence has really been, how do I discuss this with patients?

How do I make it efficient for me? You know, I was spending 15 minutes per patient talking about hypoglossal nerve stimulation when there was one option. Now I'm spending 30 minutes per patient. But it's well worth it. But then as we incorporate that, so for me, as of this point, about 40 percent of people who undergo hypoglossal nerve stimulation in my practice are getting Genio. And so that can continue to evolve as more treatment data comes out, as I get more comfortable discussing this with people. This is new technology, new conversations, and so everything keeps evolving.

Maybe a question from my side as well. When interacting especially with the investor community or even the analyst community, one of the questions that we're always getting is, what about the GLP-1s? You know, they are introduced, there is a lot of debate around, will they enlarge the market, will they increase awareness, will they shrink the market? And I also would like to hear a physician perspective, in the sense that what are you seeing in your daily practice? Are you seeing more patients since GLP-1's were there pushing and helping awareness? How do you position this? Do you see a positive impact for AGNS, more an impact where you see, oh, it could slow Just curious to hear about your thoughts on this.

I mean, I love GLP-1s, I prescribe a lot of ZepBound. I think it helps with a lot of other things, not just obstructive sleep apnea. Obviously diabetes, depression, addiction, there's lots of things that are great about it. I think when I look at it objectively as a treating physician, I look at the surmount trial data, obviously from Lilly, you look at the average patient that came in, you look at obviously a BMI over 35, 20% total body weight loss after 12 months of therapy, all great outcomes. AHI reduction, 50%, great outcome. Average incoming AHI of 50. So that means on average dropping to 25, which by AHI standards is still moderate obstructive sleep apnea. So I look at it as a way of patients who are coming in who are not good candidates for hypoglossal nerve stimulation. This is a great option. It brings more people in. They're coming in for it. Ultimately, the majority of them are going to get better, but still be candidates for hypoglossal nerve stimulation, and in that case, I'm more than happy to do it, I'm more than happy to see them back, especially if they can't tolerate it or stop using it after a year in their recidivism rate, and then offer them other therapies like hypoglossal.

Thank you. Yeah, I think for us, very similar, you know, again, I think if you look at surmount trial, a few things I could tell patients, again, 50% of patients saw improvement, but we also have 50% of patients that don't, so there are, you know, so if you still have residual sleep apnea, this may still be a treatment option. We've seen that it's been a motivating factor for patients to want to go get a sleep study, because they want to see if they can qualify for a GLP-1, and then once they actually identify that they have this condition, then we've seen patients more motivated to address their sleep apnea in the, kind of, I guess if you'd say in the short term, because again, a GLP is more of a long-term treatment plan.

So, we can summarize that you see this as a kind of tailwind in moving forward to have more patients also becoming eligible and successfully treated with Genio, to be very precise.

Mo, I don't know if you have the last question, but I'm also a little bit of time-keeper, I have one final question, which is really what gives you confidence in Nixoa as a company and Genio as a device that will be successful in the market, you know, clinically and obviously commercially?

I mean for me there's a couple factors one bilateral stimulation I think is important having bilateral stimulation of the tongue to open the airway is important for me from a treatment practice perspective the other is the launch I feel like there's been a lot more support for us as surgeons to get through and really understand the procedure and do it which I was not accustomed to or was not exposed to with Inspire, at least in terms of talking with other surgeons. And I think that's very important for us as surgeons, not just for adoption, but for comfort and for understanding how this incorporates into our practice.

Yeah, so for me I think there are a lot of innovations in the in the sleep medicine space, so it really depends on, I think what matters Whereas more to me is implementation. So that's largely where I saw a huge difference with NYXOA. You guys have invested in working with surgeons and educating the surgeons. You've invested in working with sleep medicine physicians. Sometimes we're usually the last ones everyone comes to. But you guys made sure to involve the sleep medicine committee from the very beginning. And you've been very focused on the patient journey from beginning, middle, and end, and ongoing. And what I really appreciate is that sort of the company vision motto is to keep sleep simple. That's been great because I think the more we can simplify this for providers and patients, it makes the whole journey better for everyone.

Maybe building a little bit further on that one, specifically for you, Dr. Jain, also post-implant. You know, like in patient management, what are the expectations that patients are having coming back? Do they want to be, you know, that you call them back every three months? Do they want to say, okay, as long as therapy is fine, just leave us out there, and we are doing great? How do you see the role of a sleep physician in this post-implant follow-up? Because I do think it's important knowing what you do with CPAP patients. So how would you position an implanted genio patient in your post-implant follow-up?

Generally fairly similarly, you know, even with my CPAP patients, we see them fairly regularly over the first three months. And then once they're compliant, then we generally will see them once a year. So with Genio, we give them, you know, similar expectations. You know, once you get implanted, you'll be activated about two months later. Usually within the first month or two, we're finding, you know, a therapeutic amplitude for them. What's been impressive for us is we've been doing awake endoscopies earlier on for our Genio patients, and we're seeing very robust opening of the upper airway. So that's great as the provider, and it's very reassuring to the patient as well. And so then generally, we'll either do a follow-up sleep study, and then also depending on how the patient's tolerating therapy, then we'll start to space out. But usually we then see them about once every 6 to 12 months.

And really the last question on this one, because you know that with Genio, we also have already strong results on complete concentric collapse patients. CCC in Europe, we're already on label. in the US, I will not steal the thunder of our clinical officer, he will talk about the access trial, but how important is this for you when you have a technology where you know that it can treat successfully both CCC and non-CCC patients? How important is this in going forward?

I mean, it's important for us. Our population is generally about 20 to 30 percent of patients with CCC. Of those that are surgical candidates, obviously they've been kind of at a loss up this point and then so this is a great option with that and then the second is it could make keeping things simple if there is nothing off-label for it then process of drug-induced sleep endoscopy may not be necessary overall depending on the provider that's administering care yeah I think it helps broaden who has access to therapy so rather than saying I'm only going to go look for CCC or not CCC, now we can offer this therapy to a wider range of patients and say, look, we see that this works whether you have CCC or not, whether you have positional sleep

apnea or not. And so then we know that we can keep this option on the table in terms of a treatment that could work for you.

So with this, let's open it up for questions in the room, Q&A session. Also the online questions might come in, but let's start first with the people that we have in the room. I'm sure you have some questions.

I wanted to ask about when we typically, from our side, think about new products, we think about the patients that are out. It feels like, at least based on some of the comments here, as opposed to going from that top-down approach to who you can capture, it's looking at smaller subsets of patient populations from a bottoms-up approach, whether it's the flight attendant or some other patients that are out there. So I'm curious to hear about how you think about the difference of, you know, going after or going after, you know, subsets of patients as opposed to, you know, saying, hey, this is something that more broadly, you know, is addressable to everyone that's out there. And I know that 40% at least, you know, was that mix that you're seeing today. I mean, how do you expect this, you know, mix to shift over time? is 40% pretty much this bottoms-up number, or are you there?

Yeah, I guess I wouldn't look at it like we're targeting subsets of patients, at least the way I try to run my practice is everybody gets all alternative options to pap therapy. So for example, if a patient comes in and they're not tolerating pap therapy, not complying with pap therapy, we do a drug-induced sleep endoscopy, we see what they're a candidate for, which if it's hypoglossal nerve stimulation, I present both options. So everybody gets the same options to start out. What ends up happening is there's a differentiating factor when it comes to what people then are told about the objective factors involved, which the main ones for me being in Houston, I guess in Texas in general, where people generally care about their appearance, is do they really want this second incision? Do they want the IPG here, which can be seen to a degree? Do they want to have to deal with that MRI conditionality, like I said, with the lithium-ion battery? And if they don't, then they're automatically differentiating themselves to something like Genio. In the subset type of conversation, then we talk about post-drug-induced sleep endoscopy, right? Then we're talking about, okay, now we see you have CCC. You're not even a candidate for INSPIRE. So Genio is really your only option if you really want to do hypoglossal nerve stimulation. So it's more like it's capturing more people into the total population of people looking at alternative options to pap therapy. At least that's the way I envision it.

Yeah, I think, I don't think that we're looking at subsets. I think, you know, anyone that comes to my office, we're talking about all the treatment options from the get-go, because I want you to understand that if you can't tolerate CPAP, that there are other options for you. and we know like pretty much nationally doesn't matter which center you go to at a year 50% of patients are still using CPAP and 50% or not so and then and then what we've seen is largely once you have the discussion with the patient they generally will kind of help self-select to if they're a better candidate for one or the other whereas you know we're not always having to be the ones to make that decision because sometimes it is sometimes it's a question of like for example if it's age I let patients know like if you pick the alternative you're

gonna have to go in for a revision surgery every seven to ten years do you have a sense of what your health status is going to be ten years from now like oh well if you're worried about that then maybe we want to consider Genio as compared to the alternative yeah maybe on you know the reimbursement landscape today right it's it's less you know clear than it was a couple years ago right and I'm not as much interested in you know how those six but more interested to hear about how that about adopting you like Genio if there is again does that

maybe open the floodgates more just toward technology versus I think the reimbursement thing to me is funny mainly because I'm not a financial guy I just cut people I think I think when I when I think about the reimbursement landscape I think about when we started doing Inspiron when I started doing it 2019 and insurances were still rolling out and authorizing it and and people still adopted it and so we adopted it we adopted it kept going up insurances started to follow through and more started you know having pain you know authorizing it and then ultimately this whole thing and this is just my outsider looking in because again I know nothing about finances and insurance and all I hear is you know you know Medicare was going to increase reimbursement everybody just went totally crazy. Totally crazy and I was just like I don't I don't quite understand because it's not like we were doing poorly before this but now like this number is getting thrown around the facilities are talking about it they're all going ecstatic but it's like we were already doing it nobody was not doing it and now we're like back to the original and it's like I don't understand we're just we're the way we were so I don't know why people are unhappy I'm still doing it. It's still the same.

I mean, I'm a sleep medicine guy, so I probably don't, I'm not the one billing for these procedures. I think where I've seen, I mean, what I've seen in my area is that there are a lot of ENTs that offer HGNS therapy, and when you consider how many were treating sleep apnea prior, not a lot because the success rates were not, so you could get reimbursed for a procedure that had a very low success rate. Generally, you know, most providers don't necessarily want to utilize those therapies, but now you have, you know, interventions that have higher success rates and are reimbursable, so you're seeing a lot of ENTs that have now said, hey, you know, I want to come back to treating sleep apnea again because now I have confidence that I have options for my patient.

And it's also a nice bridge to the next panel that will be, that are specialized in reimbursement, and they will definitely go a little bit more in depth. Maybe some other questions from the other side of the room for both physicians. If not, you have been extremely clear I think. So thank you again for joining us and thank you for the questions. So let's now make the switch to the reimbursement expert panel. The team from JD Lyman, they will be coming in in a second. I think I'm hearing them coming. yes here they are joe carla please have a seat let me also invite scott holstein or chief commercial officer so maybe we can start again like we did with with the physicians with a brief introduction of yourself and then scott has prepared some some very interesting questions for you good morning everybody nice to see you all here my name is jolaine devers i'm a partner at

JD group. We are a market access firm based out of Minneapolis and the Washington DC area. My background is that I've been in reimbursement about 35 years. I know that makes me older than most of you in this room. And that I've had the pleasure of working for on the provider side for a while and that at a very large payer United Healthcare for a number of years in reimbursement Policy Fraud and Abuse Technology Assessments. Then got recruited to Medtronic and I have spent the last 25 years with my business partner Carla here doing consulting. I am the certified coder in the group and it's a pleasure to be here today.

Good morning. My name is Carla Monticelli and as Joe just said I am her partner. I often say other than my husband she is my longest relationship. So we've worked together for 25 years prior to working with Jolaine. I spent my first 10 years doing government affairs and public policy work primarily in health care. And along the way, I think a few things of interest is Joe was a gracious partner and I spent 10 years in the medical device industry doing an 80-20 role where I was the vice president global of many startups. And so what was interesting about that was seeing the inner workings of an executive committee and the trade-offs and interactions between market access, clinical, regulatory. But combined, yes, we bring a number of years of experience, and it's a pleasure to be here today.

Good morning. I'm Scott Holstein. I only have 28 years of experience in the medical device space, primarily in class 3 implantables, mostly in neuromodulation, most notably with Guidant, which is now part of Boston Scientific, and then St. Jude, which is now part of Abbott, and a couple other small companies in between. And I've spent my entire career introducing new technologies to the landscape. The last two years, I've spent building out the United States commercial team across the United States and happy to report where we're at today after our first nine months of launch in the United States. But to kick off this panel, and we just started asking the questions in the last panel, why is reimbursement such a hot topic? How did we get here?

I think it's important that we start with a little bit of history as to how we did arrive here. Many of you may remember that when Inspire entered the market, they used an existing CPT code, 64568. Then they got an additional Category 3 code to report that additional lead. So they reported those two together. When they converted to the Category 1 code, the 6-4-5-8-2 code, that is when they, I just had a, so they converted to the Category 2 code and converted, quit using the 6-4-5-6-8 and then had their dedicated code, right? so now we face this interesting challenge in the market where there's been a form factor change so we've removed that that one lead and now there's questions from providers questions from the market questions from industry about how are we reporting this procedure today and many believe that 64568 reverting back to that made a lot of sense the questions continue And so it is beholden to the American Medical Association and the CPT editorial panel as authority with CPT to answer those questions. And that's what has been circulating today. So what's important to note is that enter in a number of other things. 64582 has been historically also used for other technologies with different indications. And what has evolved over time is a differentiation or a bifurcation of costs. So the other technologies cost a great deal more than what the hypoglossal space has been in the past. And CMS took a look at that and they said, you know, we don't want to be underpaying or overpaying. And so, rightly so, they've created these HCPCS codes for facility reporting. So C codes were created. They became effective in January for the hypoglossal procedures, your insertions, revisions, removals, those kinds of things. And they've been priced accordingly, importantly, as parity with the existing Category 1 CPT codes. So other than the numbers and letters, nothing has really changed, and the payers have responded appropriately. They have not opened up coverage policies, but they've added the codes appropriately to the policies so that when claims are submitted, they're adjudicated appropriately.

Would you add anything to that, Carla? I would just add that it's really important to understand that the C codes are for payment for the hospital, outpatient, and ambulatory surgery center for Medicare, and it does not impact coverage so we get that question a lot and there's been no change in coverage it's just a reporting for the hospital and parity and the proposed rule that everybody probably saw with some happiness last week also restated that the C codes are here to stay and it's not an unusual or an anomaly so yeah I think that we would expect the C codes to hang on a long time there has been a lot of history of other technologies you're looking at Urolift, for example, has had C codes for hospital reporting under the Medicare program

for a very long time, and we could go on and on, but we don't anticipate that to be changing anytime soon.

During the previous panel, one of the physicians or both of the physicians were asked how all of this change in reimbursement or the unclarity influenced them, and the general response was it's been business as usual. They don't understand what this noise is about because they're treating the same patients that they've always been treating at the same rate. And so can you speak to why at the physician level everything is business as usual, but at the payer level or analyst level or financial level, there's a perceived unclarity in the Sure.

I think that in general, really from a CPT perspective, nothing has changed as of yet. There has been a meeting at the CPT editorial panel where they're trying to clarify that, give more direction in writing within the manual itself to point providers in an appropriate direction of hypoglossal stimulation. So that will come out in January, and that will provide a little bit more clarity that providers and coders can point to in the manual, because that's one of the first questions we get asked is, well, how do you know that? Well, here's where it says. type of thing. So they're wanting that. And I think that creates a little stir. The shift from the facility reporting that CMS has pulled in, I think, you know, people aren't really sure what that always means. It's not uncommon, certainly at all, but it's new to this space. So there's always questions about what does that mean when you change coding? What does it mean for payment? The answer is there's no difference. They have they have crosswalked the payment so there's parity there and then the natural next question is well what does that mean for coverage and what we have seen there is that again payers aren't really very excited about reopening coverage policies hypoglossal nerve stimulation is a well-known mechanism action they've had coverage policies for many years but in order to adjudicate claims correctly they've got to add those to the policies so again people can point to something in writing that says oh here's where it goes now we know how to do that and then payers are able to program their systems to adjudicate claims correctly so i'm in agreement with you to say i'm not quite sure why there's so

much you know uncertainty um the mechanisms are there they're just they've just changed a little bit but they're just they're being adjudicated appropriately and we're just seeing some things being clarified within policies to update current coding situations I agree I don't really have a lot to add other than I think change is sometimes hard for people so just the nature of change being what it is it can create a little uncertainty but we feel really good about the coverage landscape which ultimately is where the payment you have a payment established without coverage that's where things go a little awry and that's not what's happening the payers spent a lot of time evaluating hypoglossal nerve stimulation, and it's well covered, well documented. And while you might see a name brand in a commercial policy, that is also not uncommon as the first to market also leads it. But we're not seeing, as Joe said, revisit. And so it's a for example. And just so everybody knows, if they were to make a change, those are long drawn out policies that would not be a surprise. And we don't expect that because they don't like to pick winners and losers in a hypoglossal nerve stimulation. They believe it works, and they're going to cover everybody, we believe.

So I thank you for this clarity. We focus mainly now on Medicare, and I think it's very clear with the C code for Genio, we have the C8011, as you well explained, and also with the proposed CMS facility payment increase, I think we are even set up to have more motivation also for facilities to continue doing a GNS with a specific coding also for a genio that's one aspect as we are a young business you know just launching in the US Medicare patients are still a minority of the patients we treat so we are talking about less than 10% of patients that are covered under Medicare and the other 90% are covered under commercial payers so maybe can we elaborate a little bit on the commercial payers like how you see this and what was the impact so far because from our perspective you all have been listening to me during the earning calls we are in a great position we have the 100 percent prioritization so scott and the team did fantastic on this but maybe also nice to hear your perspective like commercial payers how do you see this evolving with commercial plans our experience has been that they tend to contract higher than Medicare rates in the implantable space.

And those contracts are set based on the CPT codes. With, you know, shifting of chairs, they don't tend to recontract because it's administratively, you know, just a hassle, if nothing else. So what we see in those instances is that they will ask or require providers to use existing contracted codes. So for example, if they were contracted under 64568 and then there's change to a different code, whatever that may be, a C code or a new CPT code, They may keep 64568 in their contracts and agreements until and unless they open the whole contract to renegotiate. That doesn't typically happen mid-year, usually during an open enrollment period is what we see. But it is not uncommon for payers to have requirements of specific codes because they're linked to negotiated contracts. And we see, really, I think we've experienced, Scott, we've heard some really very favorable commercial payments coming out for Genio. So I think it's really optimistic, actually.

And I would add a couple things. I would say, first, the code's changing isn't going to change the contract rate. So just in that simple term, whether it's a renewal or that, it could be a one-year, two-year, the rates will be based off of Medicare or the percentage of Medicare they pay above. and then on the coverage side I would say we did we conducted a payer ad board about 18 months ago now and just to put a exclamation point on what I said earlier is they all agreed that the mechanism of action they saw no reason if payment is parity with a facility setting that they would pick a winner or over a loser and so that's they're like the rising tide is going to float the boats we believe it works and we had six commercial payer medical directors that we talk to.

So it's very public information that inspires pursuing their own CPT code. So how should NYXOA think about that and what's the timing of something like this?

So the next opportunity for them to do that will be for the September CPT editorial panel meeting held in Minneapolis. You're all welcome to come visit us at home if you like. But that would be their next opportunity. And if that is positively received, if the panel votes that through, those would become effective in 2028. And that is because they have to go through, under regulatory process, the RUC and all of those kinds of things. For Genio, we have been talking, we talked with Inspire, and we talked with the AAO H&S, and specialty societies play a really important role in the CPT editorial panel. They are advisors. The panel relies on them very heavily for their expert areas because those that sit on the panel are probably a dermatologist, an orthopedic surgeon. They're not experts in this field. So they do rely on the societies for that. And in talking with AAO HNS, the panel had given them prescriptive instruction to address the CPT code set, make sure that there's clarity, and make any changes that they see fit. And AAO was clear with us and other industry stakeholders that they intend to start that process themselves. They want to take it forward. They want to be the ones to take a step back and really evaluate the code set from a holistic perspective not just a single company perspective and they were very clear about that so we have honored that process and and respected that um it remains to be seen that agenda scott will come out on friday so we'll be able to see exactly what's on the agenda and who has submitted so we'll know that a little bit more on friday but that's what that maybe maybe i i think I'll make one more quick, sorry Oliva, I didn't mean, even if let's say that application would go through, remember that the code still exists today. It doesn't orphan GENEO in any way. It provides perhaps more granularity, again introducing another code, but it doesn't orphan the GENEO procedure. We still have, you know, 64568, 64582, whatever the clarity will be that will come out for January. But it doesn't change anything here. And the panel's very, very prescriptive about not orphaning anything that already exists in the code set.

And I would say AAO HNS is also very strongly in support of that. They are looking for a holistic approach and not to leave anybody behind. So we feel really strongly about where we're headed with them.

And maybe to elaborate a little bit on that topic, from a company perspective, of course, we also are thinking strategically. So it is clear that we want to be very supportive and collaborative with the association, the AAO, at the next surgery department. That's one aspect. On the other hand, we also have strong clinical evidence that could help us in a meta-analysis if there would be a part going for a dedicated code but I just thought of clarity and also following the advice of experts we do believe that collaboration is better than you know trying to do your own thing and why am I saying this if I remember correct also the previous submission for inspire for a dedicated code for inspire 5 it was rejected during the editorial panel so no they are resubmitting this everyone does what he or she thinks that they have to do Genio, and from our perspective, we want to be collaborative, we are well prepared for every scenario, but as the way it's going, there is no risk that we would fall without reimbursement. I think there is absolute clarity from CMS with our C code and even some potential upside. The commercial payers you also addressed. I have one question, and I know that this is also a burning question. What about the physician fee? because there are also specific guidance in how to calculate and how to come up with a physician fee. How do you see this and how do you see genial positioning in this because we have a totally differentiated technology from a surgical perspective?

So the CBT codes, again, exist to report procedures, not necessarily technology and devices. And those procedure codes exist today. we will get further clarity I think from the CPT editorial panel and and the discussion was not to use one code to direct to another there's always going to be the direction that we leave coding up to the providers it's their NPI on the claim and their documentation needs to support use of the appropriate CPT code and I'm not sure Olivia if you were also alluding to so let's assume the code application is successful right for the new form factor in September it will go through the RUC process

and they will look at similar procedures and going back to where Joe started in the beginning of 64568 plus the T code was how they build at launch so I think it's reasonable to expect that the new payment for the new form factor will be in alignment with 64568 on the physician So a little bit less than where it's at today.

So just for clarity, this is not referring to Genio. It's referring to competition. Just for clarity. Okay. No, thank you, Scott. I know that maybe you have some further questions.

I would like to have questions from the group. Perfect.

Be kind.

Maybe then three, the absence of an idea, why or why not?

Do you want to answer the panel rejection question?

A lot of questions there. So the panel, I mean, they evaluated. There's five criteria for Category 1 codes, right? And I think this group's probably very familiar with it. Two, at least two peer-reviewed publications with no overlapping authors, no overlapping patients. There was a lot of debate about the new form factor. So FDA said it was a PMA supplement, but this is a new procedure, and let's not forget that CPT is about the procedure. So there really wasn't a peer-reviewed publication at that time on the new procedure, and there was a lot of questions about that. That is what I believe is a large part of the discussion and the data. So if I pull that thread through, if there's a new publication, will it have a better or different outcome in September? Possibly. but again we don't know where the society will weigh in or there's a number of moving parts but there was a lot of discussion on the data and i think levinova also might have a publication out so that may bolster that if you will and then the other part on the ruck i will say is that when they go to do the ruck it will be the aohns that will do the survey and they develop a list of reference services to look at are you more like this less like that and the surveys go out there's no manufacturing involvement in those surveys right and you need to have enough widespread use in that procedure to do that so based on what they've said there's in some of their earnings calls they say they've had a number of

procedures I don't see that being an issue I would see that being very similar what was your question about CMS so CMS does not have a vote in that process they have a seat and Dr. Edith Hambrick has that seat and she's very astute and and will definitely be reviewing the literature as well as the other criteria I to be honest every CPT meeting is its own meeting and if the panel wants to pass it they'll pass it if they don't they'll find a reason not to. And it's hard to know. But presumably, if they can meet literature criteria, I wouldn't imagine that it would be difficult to get over the line because I certainly think that their utilization is probably decent.

But again, I mean, I want to link it to Genio. So regardless what is happening on that front, there is no risk for Genio that we will fall out of coding, coverage, payment. I think you also made it very clear on that one.

Even if there's a new code for, let's say, the new form factor, again, they don't delete others and orphan existing technologies under existing CP2 codes. That is a precedence that's been set with drug-eluting balloons and stents and all sorts of things over the course of time. So I wouldn't foresee that that would ever be an issue. It would just be adding granularity to the code set.

So in summary, we are 26. For 27, we don't foresee any changes. 28, potentially. If not, it would already move into 29. And when we listen to the Physician Association, the AO, at the next surgery department, they are more in favor in a more comprehensive solution that will cover everyone instead of having companies playing solo slim, is this what you say in the U.S., and going by themselves. Is this a correct summary?

That is a great summary.

Thank you.

We have a few questions from the live feed. Can you talk about the pathway to obtaining a new Category 1 CPT code for Genio, which I understand you are pursuing? Do you plan to make an application at the upcoming AMA CPT editorial panel meeting in September? what's the level of confidence you will be successful and it doesn't sound like you think the lack of a category one code is a headwind to adoption is that correct so all the easy questions I mean like okay so I think I mentioned that we have been working with and talking with quite closely the double AOH and S and they've made it very clear that they are their strong preference is that they are the drivers of this.

And it's very common for societies to take the lead in putting applications forward, particularly when it's category one. They like to be able to have a little bit of that less bias approach and take control of questions on procedures and technology, literature, those types of things. And they've made it very clear to us, loud and clear very specific and so we have honored that we have not submitted an application for the september meeting so you will not see that for genio but again we'll still have our category one codes anyway one more question from the live chat why would inspire push for an approach going for their own dedicated code that goes against the request of a hns so i think we are in the wrong room to answer that question so honestly I don't know I would say we can't speak to my crystal ball is a little fuzzy don't know everybody has their own reasons inside and so I think that is a

question for them more questions back here Joe please if sorry if the current submission is accepted in September, would the plan then be, you know, for Nixo and Genio to submit a separate submission with the expectation that that would be effective in 2029?

So an interesting question, Joe, and first of all, we have never chosen the path to be a follower, you know, like we do believe in our own strength, and as we were just learning also to do a submission for a coding, it starts with having the literature 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 when 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. 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 surgery. 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 coding or a dedicated code. So that is the answer. 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 rejected again no no i cannot make jokes so no but maybe we should wait to the outcome uh what will happen after the first rejection but one never knows well i want 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 thank you exactly and i will just put an exclamation what you said olivier we are positioned well positioned

to make a choice exactly and and we have the criteria in place to do that if it strategically makes sense so so what i would say is that whether 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 AAO. And so I believe we would submit that in November for the February meeting.

That's been their strong preference.

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.

And the February meeting is the first meeting. There are three each year for the cycle. So February, May, and September would be all of 2029. The September RUC, September CPT meeting will have a February RUC.

So if you submit in November for the February.

May RUC, 2027, for a 2029 implementation.

It has to be RUC because prior to rulemaking, because federal statute requires that new codes go through rulemaking, so they first RUC and then it goes to CMS. that the RUC would be in 27 and not 2028?

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

It's about three 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 RUC'd. It's not Genio. 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.

I think we answered all the questions on reimbursement. I hope it has provided you with more clarity. Jo and Carla, thank you again for making time to be with us. Thank you. Scott, you stay a little bit because you're me. 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 20% quarter-over-quarter growth with 7.7 million euros. 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 lies with Scott and the entire team, so we will start with the leading indicators, then we will end up with the 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 the next three 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 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 two sessions on saturdays and so starting with our our cadaver lab next week we'll do a morning session and then an afternoon session last year how we managed the demand was we had one surgeon training on friday and the other one on saturday but it was very difficult for surgeons to take the time out of the labs uh where where they 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 into q3 i think what's more important is that we've doubled the number of vac approvals in the last uh three months and so we we exited uh q1 with with 90 approvals across the united states now we have 180 uh 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 uh what we're encouraged because these numbers demonstrate uh progress in uh adoption if you look at the patient side we've had almost 1200 unique patients that have been identified by physicians physicians like dr wang and dr jane they've brought the physician the patients forward as candidates for hypoglossal nerve stimulation so pap failure patients and of those 1200 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 Nixoa. And when a patient consents into our navigation system, they are allowing us to manage their patient pathway. And the physician offices like Dr. Janes 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 the future of q3 we're in a much stronger and a larger foundation than we did coming into to q2 and then finally at the bottom we did we we did a backwards analysis over the first six months so this doesn't include q2 this This is just in Q1. After Q1, the first six 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 breathe for a second. No, no, because these are a lot of numbers. And you see 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 hippoglossal 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 entered with 40 sales reps in the 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 it's it's truly impressive 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 interpreted it. So if there are questions on this one, maybe it's a good time.

David, I'm sure you have a question. ...one, the number for what the exit rate is in Q2. So trying to get an understanding around maybe what the difference could be on gross and whether or not it's fair to assume that that capture rate of the...

Can I take this?

Yeah. 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 one or two 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 four the the additional 15 reps that that olivier just referenced they're just now opening new accounts and so we're seeing a broader influx of of patients and so it's hard to model that and then you know to the to the physician's point we have we have accounts come in on now that have never worked with us but 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 of the adoption of the therapy was there a question from there was a question from the live chat and 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 off and effective implant?

Yeah, 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 a 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 because it's that broad, and to give you an average would not be indicative of what the market's 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 feed on the street, 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 feed 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 two months, two or three months of this year and definitely setting us up in a stronger position also for entering 2027. So I think we covered the questions on this slide.

So Scott, maybe also now go a little bit more into the patient experience, physician experience that you are hearing from all the physicians 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 there's a lot of physicians that have come to us and they've they've they've walked towards just wanting genio because they want to be the experts in their their marketplace this 88 percent 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 percent the dream study and Jay's gonna 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 Levinova so 70% of the patients in dream had a positional 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 perform an 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 tunneled up to their to their chin but then also you know 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 hypogloss nerve stimulation but in most implantable products our conditions are minimal and And then there's also this desire for patients for an implant for life, and that's because our activationship is the brains to the operation. The average age of patients in all of these clinical studies was mid-fifties. 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 activationship and put it in its charger and have it 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 Q4 and beyond. And to restate something I said on the last slide, we have surgeon training every other week. We have a high demand for sleep training 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 five-minute break and then we are back with clinical data and looking forward on the market dynamics. Would that be okay? Can I just ask five minutes, not make it ten, but please limit it to five and I'll see you back shortly. Thank you.

There's two chairs over here.

So, yes. Okay, thank you. And we will continue with Power 2. So, part two, we will cover the clinical update. We have our Chief Science Officer Jay Subroyan with us. We will talk about market dynamics with our Chief Strategy Officer, Ashley Middlestad. And then we will talk about our financial update with our CFO, John Laundrie. So maybe can I call all three? 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, micro, yes, okay. So, Jay, from a clinical perspective, what can we expect? Is everything okay? Okay, from a clinical perspective, Jay, so what can we expect?

So, thank you. 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, you know, Genio is not currently approved. We have a warning, not a contraindication. But just to give you a little bit of background why CCC has been challenging and avert. We have, you know, ENT surgeons, 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 palate 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, you know, we are finishing the last of the patient follow-up for the ACCESS IDE study, which focuses on hyperglossal nerve stimulation, in this case, geniotherapy 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 better sleep study which was done in Australia about five 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 percent 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, how we are completely differentiated. I think also in our vision, make sleep simple. This is what we mean 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 it sleeping on his side, on the back, all these things, so it's supporting also this mission. And Jay, I mean, already extremely strong work with you and the team. Sorry that you cannot disclose more, but I think everyone understands why on access, but from a timing perspective, timelines unchanged, they remain the same.

We submit Q4 and we expect also a positive reply and then by Q1 we could be adding this to the label in the US, to be very specific now next up j publications yeah so the data is one thing then the scientific dissemination of the data is equally important what you see so there are two main themes if you look at this right like one of them is there's a heavy focus on generating evidence for uh actually three main themes uh on ccc whether it's through clinical studies or real world outcomes that's one and more real-world outcomes you just see one 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 remove 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 the better sleep study that's has data for both CCC and non CCC that you saw real-world data that about 30 patients from Marburg in Germany by professor Richard Burke that's currently in review we just got feedback from the reviewers last week so we will have that addressed get it 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 nerve 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 we did talk about the access study We will write that up the same time. We'll finish the data, 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 i triple s in la will be very important we'll have a lot of new numbers to disclose specifically on ccc patients so also looking forward seeing you there as well and updating you on this okay thank you thanks olivia for this update stay with us and we will move now to ashley maybe ashley 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 middlestead i'm the chief strategy officer for nyxsoa

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 nyxsoa since 2023 thank you so tell us actually what is happening in the market so so i would say so i love this question um 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 under penetrated so all of those factors obviously play well and with the clouds parting on you know the coding situation i think there are some other drivers that we're really seeing play out well in the marketplace especially for genio um 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 device and where it sits what we're also seeing now with GLP ones because of our timing in the US market you know we didn't really see the major disruption that some others experienced and for us right now we're seeing it as 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 you know for us we obviously we haven't been chasing BMI we're looking for more you know interesting and complicated airway options so that's I think been an interesting one for us and seeing that definitely as 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 two 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 the Genio pathway we've leveraged that working with physicians and patients in working in HST as well as PSGs. 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 coding 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 wearable as 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 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 our strategic choice. And also, Jay, you can also share your thoughts on this. So it says GENIO focuses on complex airway openings. So we have our cut-off BMI 32. Strategically, NYXOA always has chosen not to build evidence in going with BMI 35 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 for GENIO this 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 based on this. So there are a couple of reasons, right? Like when we're trying to power a system externally with the higher BMI, it becomes much more of an energy requirement. We can definitely reach, you know, if you really crank up the amplitude, we can. And we do have anecdotal evidence we can probably go up to BMI of 35 and have an impact. So we wanted to get into the market before we explore all of these opportunities. The biggest advantage or 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 we hear and some of the physicians here will agree to this, it's not a one 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 a geniotherapy, 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 geniotherapy that's currently indicated, even without going to the BMI of 35. Oh, sorry, there's one more aspect that we have to think about, right? GLP-1, the OSA, it's a mechanical problem, right? Like the GLP-1 can reduce some weight for these patients. Maybe they lose some visceral 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. That's one of the main reasons the residual disease burden for these patients will remain significant that warrants an additional treatment, in this case a hypoglossal nerve stem.

Sorry, Lili B. 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 obstructions. I think that's where we differentiate. Just wanted to point this out. But actually, I will let you continue.

Oh, yeah. So just really briefly, in addition to what we hear from physicians every day, we did some double-blinded research, and we found, you know, again, surgeons value the option of Gineo as well as the Gineo 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 today 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 one of the things that I'm also excited to see as we hear from physicians and especially patients is you know you've talked before about the 20 to 25 percent of patients that refuse other HGNS 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, you know, at a really high level, these are 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. So a lot of patients decline surgery because they don't want to have the visible neck or chest scars, 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 their career. And we have seen patients come forward, example, nuclear facilities workers, that are looking at Gineo in particular because it's a passive implant. The other one is replacement procedure concerns. from a patient perspective, those 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, you know, 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 the patient perspective, those are the three that are front and center and when we say patients have declined for you know the battery design in other solutions the 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 um you know obviously expecting to hear more at isss the other one we hear a lot about is mr conditionality and so So, obviously, any patient needing a lot of MRI-dependent care, we've got three torso, MRI conditional, three testlets, thank you, in the torso. And lastly, obviously, position-dependent OSA, you know, obviously not a factor 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. So 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, how we see the market continue growing even double-digit, but also Genio's unique profile, like Ashley was highlighting because sometimes we tend to go only and how can we expand in a CCC population but if you look at the aesthetic concerns for example all these things that are really impacting and influencing patients choices any questions from the group on this one before we continue when you think about years from now when you think about the CCC versus the non CCC patient

population would you expect if there's a hundred 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 the piece behind um longer term genio adoption or you know if ccc is 30 of the addressable patients out there would it be fair to assume that it's a 70 30 split of non-ccc versus ccc so i if and j feel free to to fill in but first of all today ccc is simply contraindicated for agns unilateral stimulation so just by offering these patients also an agns solution it's already

large wind and will also have a positive impact in increasing the patient pool because today 25 to 30 percent of those CCC patients cannot be treated. That's a question I may be answer one. 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 then we're coming back to what we explained previously so on one hand bilateral stimulation clearly differentiate itself from unilateral in being effective in opening a more complex or a complete concentric airway obstruction and on the other end 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 stim, and yes, by also offering a treatment option with patients where you have higher BMI. So that's our answer. Jay, if I'm forgetting something, please.

No, actually, I would defer to Mao, and I want a surgeon's perspective. Mao, do you?

Well, I would say, number one, generally speaking, physicians and payers don't love If CDC was no longer a warning that actually indicated, I think it would be a big boost because it would be for physicians to 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 this, just to 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. It is market expansion in terms of these 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, yeah, to second what Mal said, You know, it does have to do with the population of surgeons who do not want to do drug-induced sleep endoscopy just because it does 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 a practice.

Thank you. I hope this is answering the question. Any questions from the online audience? okay so then we can continue and we will now turn into more of the financial aspect so john thank you also for for for joining us on this one and also sharing your view on the path to profitability and of course talking with the recent race that we did that's right no thank you very much olivier for those of you who don't know me and haven't had the pleasure of meeting my name is john landry i'm the cfo here at nyxoa i joined in the fourth quarter of 2024 this is my third medical device company.

I started my career in public accounting and probably at the risk of dating myself. I started with Coopers and Librand before the Pricewaterhouse merger. And at that point, I audited mostly hospitals and manufacturing companies. And then when I moved away from public accounting, medical device was a very nice marriage of the combination of hospital healthcare and manufacturing. So it was a nice transition into the medical device space. I've been here for over 20 years now. Again, third medical device company. The first two medical device companies i joined were in a very similar stage to nixoa when i joined the company we had about five million dollars in revenue in both of those companies and we were fortunate enough to grow both of them up over 100 million dollars still going strong today so when i joined nixoa i saw a lot of the hallmarks of those two companies in nixoa 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, you know, turning now to the slides as we talk about the path to profitability, it's one of the things that Olivia and I talk an awful lot about is how do we get there and how do we get there quickly? And when you look at the path to profitability for us, the annualized revenue break-even point for us is $150 million in revenue to get to break-even. And what does that represent in terms of total market share? When you look at the total market share from an HG&S perspective, in the U.S. it's about 15%. So as you think about the 15% level, recall from a slide or so ago from Scott, when we looked at the initial six 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 break-even 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 two 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 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 the 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 percent range. So those are two 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 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 out 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 the 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 a 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 contrasts two things. One, it compares and contrasts our 2026 guidance as laid out from a revenue gross margin, cash OPEX perspective, and the operating result, and then it can pick 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, the 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 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 22 million euros. 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 19 million, and I would expect to see that continue to decrease quarter after quarter by roughly 2 to 3 million euros per quarter until we get to break even and then positive thereafter. So, this is really something near and dear to 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 especially since we'll 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 a second No, no, because I know this one and with some of you we had also some interactions, some discussions 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 trust behind this plan. So I think it's a good moment to have this conversation since we are here together. Any questions on this part of profitability?

I guess I'll ask one.

Yes, please.

$500 million in sales, right? And 150, 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, you know, the level of spend that you expect at the year in which you get to 150 relative to that number will still be able to support growth on a go-forward basis and 150 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 in 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 percent 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 HGNS 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 TTC 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.

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 get a good payment. It took inspire five years you know to get to a point where they had coverage from a decent amount of of of payers in the US 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 15% 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 expect the revenue expectations for a GNS or between 850 to 875 million in going forward next year I do think we will be touching 1 billion and if you are touching 1 billion and you want to have 150 million euros to get break even it corresponds with with a win a market share percentage where we today are 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 in ramping up, that will be the best way also in moving forward to convince everyone that we can reach this point pretty fast there is one question coming from i will let john answer but i will say no i don't agree with this but but please no but but you will understand in a second sure i think there's a couple 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 So, for us, that's how we're calculating the 15 percent market share opportunity as the baseline for our revenue target here of 150 million of revenue.

Yeah, and that's exactly what we are seeing today. The patients we are capturing, the ones that Dr. Wong and Dr. Jane were referring to, those are patients that normally would get the INSPIRE implant, today they are getting the GINEO implant. So, 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 A-GNS implant.

So, that's why I was saying no. 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, yes, it will be a combination, but Scott, maybe you want to elaborate a little bit more on where you think will be the acceleration short term and how this will.

This is on so it it's clear it's going to be from the initial hires because there's a there's a six to twelve months 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 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 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 toward 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 auths 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's that is a moving target and so but but what I'll be focused on moving forward is exactly what I presented today okay thank you so then John okay we have a question here oh sorry sorry Joe so I just wanted to follow up I know in Germany where it's market share and I

think earlier today you said that in you know so there's you know another you know six months plus is your assumption for share of the market would be how do you see the yeah it's good good question I think from our perspective we expect to gain market share and

still be at the 15 percent level in these accounts and continue to growing another factor that as we look back at the Germany experience the Germany experience before we entered into the market when it was just a monopoly the business was growing roughly you know below double digits in terms of growth percentage on an annual basis then when we entered the market the growth rate in the overall H&S market moved to like the 25-30% range so so with more you know 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 continued to be there and continue to grow over time.

Yeah and then maybe in addition to this as well, so we also showed that the current AGNS penetration is not even reaching 10%. So it's a huge pie and we do think, to John's point, when you have no monopoly, you go to duopoly, there is a third company coming, that this will only help drive more and a faster market growth for AGNS. That's one aspect. Second, we have the tailwind from the GLP-1s, where we also see that the awareness increase, more OSA patients. But no, maybe just focusing a little bit on a GNS 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 you know a competition between both companies where we see Genio as more the unique totally differentiated approach but to answer your question we want to capture 15% market share of AGNS as a total.

Based on what you said, two to three million, I think, you know, if I'm just doing, you know, to get to the break-even orders, call it, like at the midpoint of that range, does that sound, you know, reasonable for your expectations?

Yeah, so just a quick clarification. The two to three million is a reduction in cash burn, not cash OPEX. Yeah, so cash burn. So, yeah, so we'd see that, you know, that's in the near term. So we're talking like, you know, 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. Um, you know, so in terms of that timeframe, you know, certainly not going to provide guidance as to when we're going to be at the 150 today. Um, but from in terms of timing, you know, it's not too unrealistic from a calculation perspective as as you discussed.

Yes, words in your mouth, but it seems like at least for the next couple of years while you're a little more capital constraint, you are really focused on on taking share rather than investing in the 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 you know being cash flow neutral and so you're a little bit less capital constraint 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 become so stark that you have to start doing market building of your own and then also when once Livanova comes into the market you know just how you think about all those different you know dynamics and how much you as a company need to invest in yes I think from from my perspective what we want to do is

we want to 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, you know, we're looking at. You know, wearables is something that is, you know, a key item, incorporating artificial intelligence as well, having, you know, smart technology built into the device to help improve the patient outcomes even further and differentiating even further. That will allow us to continue to gain market share, allow us to continue to grow our business and continue to have those continuous cycles of growth once we get to that break-even point. And at that point, I think our philosophy is, you know, we don't want to take, you know, the cash and take the profits and just build buildings or invest in, you know, non-revenue growth generating opportunities. We want to continue to invest in innovation and clinical and in people to go drive the business further and drive further adoption of our technology. I think we have a, you know, nice pathway to do so.

I have a couple of things that we discussed today as well. if you look at you ask about traditional market development or market growth drivers we haven't we haven't presented the seat 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 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, the patients are already coming in.

Yeah, and since we all want to say something on this and we're all saying more or less the same thing, also from a business school perspective. We are giving a guidance for 26 reaching 36 to 40 million. If you look at competition, they are at 850 million. So I think it's obvious also that they play their role and invest more than we are doing, not just entering. 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 under penetrated, there are so many patients, I mean only this will already give us a lot of tailwind in growing before we're even thinking in 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 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 the patient pool already in the CCCA indication. So I think, and I hope this is answering your question. There seems to be one more question.

One more question from the live chat. Could you explain the slight difference between the 22% sequential growth achieved in Q2 and the 25% to 30% sequential growth you had guided for?

Yes, yes we can and you know it's a little bit, how do you say this, a silly explanation that I have to give and then I had the 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 were 30 days and as a small company there is a person who needs to pick the product, there 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 BS 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 are 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 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 7.7 million euros 5.2 of which came from the US and the 22% 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 $14.1 million of revenue. That compares to about $2.4 million in the first half of 2025 so we almost have five-fold 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 you know an outstanding outcome and testament to both our u.s international sales representative trying 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 36 to 40 million euros for the full year. And, you know, with the delta, the 22 to 25 percent, as Olivia explained, you know, we have orders in hand, product out the door. So, you know, 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 the when I speak of backlog I'm thinking about those number of patients that are in the pre-authorization process the 427 patients that are pre-authorization that grew 77 percent in the second quarter versus the first quarter so from my perspective you know I feel very comfortable that we have you know a good play in place we have the patients in the funnel in the pre-authorization 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 so and again our preliminary cash balance was 98 million 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 back over to a little bit 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 two 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 singer the single largest investor of the company with 15% investment or ownership in our company with us today and it's a pleasure to have Robert also he will explain his vision and also in in in how he sees value creation and then the last slide will be for me and then also talking about the vision and the mission in going forward.

Does the microphone work?

Does it work here?

I'm Robert Taub, indeed the founder and the chairman of the company. And I can say for sure that I'm the most senior person in this room. You know, I'm a serial entrepreneur, I'm Belgian, I've lived in New York for a while also and I have, yeah, more than half a century of experience in healthcare. So we have managed, it wasn't so easy, but we managed to put together this capital increase and, you know, we've reduced the OPEX and 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, you know, repeat all of that. But, yes, the whole thing is about value creation, and right now, you know, our focus is on the U.S. commercial execution and that we want to be the leader in HG&S 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, you know, we have lost with the street. That's clear. And this is not going to be done easily, but we will execute quarter by quarter, you know, our 25% growth or more. And, you know, it will take many, many quarters in order to recreate this trust, but we will be there. And at the same time, you know, we will continue to look very carefully at our OPEX in order to, you know, 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, very, very painful exercise last time. And, however, by managing this cash, we also have to remain innovative because, yeah, focus is, of course, Scott to deliver his quarters, you know, one quarter after the other. But on the other hand, we also have to maintain, you know, 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 activation ship but not used at this stage and so these are you know 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 but we will be very very tight on the cash so you know focus for the next 18 months is the launch and to quote a bank that has shown us some statistics you know we have Nixora is in a perfect situation I I mean, the total addressable market remains huge, as you know. Only in the United States you have 500,000 new patients eligible for HC&S every year. So the total addressable market is huge and continues to grow. We have, you know, 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 and you know the the growth in general will be you know 25% quarter by quarter and if we compare this to you know so that the 150 odd medtech listed companies there's It's only about a handful of them, maybe a little more than a handful, that will meet all of these three criteria, you know, gross margin above 80 percent, a total addressable market. I'm talking about MedTech company, but also some hybrid companies that are – and this is – and, of course, the growth, the annual growth, which we will be, you know, exceeding at least in the first three to four years. So if you want that is, you know, the way I see value creation now, I will not avoid, of course, speaking about the CEO transition because that has been, of course, a question that has been asked, you know, et cetera, et cetera. Yeah, I mean the growth of the company and the success of this company will be in the United States and we we made the decision together with Olivier that you know, we will have a US CEO and a US base CEO but also as an American CEO and We started the search only Was it five weeks ago or four weeks ago? So it's going to take still some time but everything is set up that by let's say late is the end of the year we will have a new CEO possibly earlier you know we're using a headhunter and that's in a nutshell what I wanted to tell you and of course I'm open to questions but you know I'm I invested quite a bit in the company from from the very beginning and And I continue to believe that we will get there. Any questions?

Okay, Olivier, then go back to you. No questions. So thank you, Robert. And please stay with us because I will now do my closing slide. And then we will open it up a last time for the entire management also for further questions if there should be any. I think you heard 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 apnea 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 US alone I mean today more or less 40,000 are getting treatment if you look at the GLP one a lot of words have been discussed on GLP once, 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 US on this reimbursement. There is reimbursement, there is a coding, yes there is an evolution but there is no I there is no reason to to to be thinking also 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 Ashley's market research that was done 88% of providers and that's physicians both sleep as ENT surgeons 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 US 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 or vision, so one OSA ecosystem, I like to use the buzzword of ecosystem because I do think today OSA is part of chronical disease management. It's not something that you do and then six months later I'm cured. No, you're not cured. You have to stay disciplined, you have to stay compliant with your technology in going forward. And when it comes to compliance, we're always talking about patience. You know 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, with Genio, that we are the best positioned company. We have a smart wearable, we will be investing short-term in making everything cloud-based. So when you do cloud-based, you also do tele-monitoring. You will have physicians that can see how are my patients doing, that can also act upon this. But you also have patients that will get live feedback on their sleep quality. And I'm wearing a whoop. I think some people are wearing an aura ring. 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 the single incision, the MRI compatibility, the designed for forward compatibility. So also there we are unique, nobody else can offer the same thing. You know 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 chat GPT cloth whatever all the names but you know 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 five years from now you know what we expect in five years is that when you're suffering from OSA you don't feel like a patient you go to sleep the system will detect that you're sleeping and activate itself the system will automatically adjust stimulation just in what you need to have a good night's 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 percent because next quarter I think we will be showing 35 So I do think we will have to accelerate even further, but also there we think we are 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 a light lunch. Thank you.

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

That all the questions were asked, so yes, this is the end. Thank you.