Morning, guys. John Block with Stifel. Good to see everyone, and excited to introduce Nyxoah, the second player in the HG&S market, recently commercial, and we're going to get after that. With me this morning, Olivier Taelman, CEO, John Landry, CFO. Olivier, I figured we could just jump right into things, and I'll start by trying to move methodically through some parts of the U.S. Genio launch and the traction that you're seeing to date. I'll start just from a commercial perspective, and I want to level set everyone. Maybe please remind us of the number of current reps that you've got in the U.S. and how many accounts they're each targeting. Let's talk about overall commercial, which I believe is around 50, and then maybe territory managers, which I think is 25. If you could give us some more details, that'd be a good place to start. Okay. Thank you, John. Before we start, I would like to thank you again for hosting us and for having us here today with you. It's always a pleasure. That is the first thing. It is indeed one of the most exciting times in our company history. We are actively launching. We started launching since August 11. To your point, always our commercial structure set up. First of all, when you look at hypoglossal nerve stimulation in the U.S., it is a business that is still very concentrated around high-volume accounts. If you see what is happening today, you have roughly 1,500 implanting accounts, but out of the 1,500, it is more or less 400 that are generating 75% of all volume that is done in HGNS. To your point, our commercial setup, we have 25 territory managers. They're all managing more or less five accounts of those high-volume accounts out of 400 segments. That is where we are aiming for today with our commercial setup, 125 out of the 400. Next to the territory managers, of course, we have 10 market access people. They are helping us in navigating together with physicians and hospitals on prioritization, submissions, and preparing also the reimbursement because also there we have great news to update you on. Next, we have 10 people, field engineers. Their only concern is high-quality implants. When a patient gets implanted and also after implant, the post-implant management, that is what they are taking care of. Next to this, we also have a small marketing team, DTC, helping also in referral networks, also on social media and capturing and creating awareness around Genio. That's a great update. Maybe if I think about the 25 territory managers, the 125 accounts, just talk to us on how that should evolve over the next 6 to 12 months. Yeah, and that's an excellent question again. What we did from the beginning is we wanted to scale our growth. We wanted to do this quarter by quarter, and the plan is that every quarter we will add 75 new accounts. As you do a quick calculation, it means that we are planning on hiring every quarter 15 new territory managers with their five accounts. If you then start calculating, today we have 125. If we do this four quarters, 300 new accounts, we are at the 425 somewhere in Q3 next year that we can be launching and focusing on. To your point, at that point in time, you'll be essentially blanketing the top 400 accounts. Correct. Out of the 1,500 that account for 75% of the procedure. Yes. Okay. Maybe just to finish on that point, it also has to be clear that in our strategy, where we are differentiating from competition, I do not think that we should go and have 1,500 implanting accounts in the U.S. I think it is much more important to have high-quality implants done to start strengthening also referral paths that you would limit yourself more to those center of excellence, as we like to call them, high-volume accounts where they would all be doing like 100-200 implants annually because that helps a lot, not only in quality of implant, but also in post-surgical implant management. You also see that there is a reduction, for example, in potentially side effects when you do something like on a weekly basis. I also think from a healthcare and health economic perspective, it makes more sense. You have been consistent about that in terms of going, call it deeper, not wider. Correct. Okay. Correct. Maybe, Olivier, just talk to us about the experience with the Genio launch to date. I'm guessing we'll get a little bit more in the earnings call later this week, but you did have the early October press release. Dr. Huang, who was the first surgeon to complete a Genio procedure, and then it also noted that he actually did five, I believe, Genios in a week. Talk to us about any early feedback and any metrics that you can provide in terms of the number of doctors trained or U.S. facilities that are now offering Genio. Yeah, no, no, with pleasure. What we did is we installed some leading indicators. First one is, of course, how many accounts are you targeting? At At this moment, 125. I think that's clear. The second leading indicator is how many surgeons have you trained? Although I have an earnings call coming up on Thursday, I do want to keep a little bit news for that as well. John, we always had an open and good relationship. I want to give you this already. This morning, I asked my commercial officer, what is the latest? We have 121 surgeons trained out of the 125 accounts. I think a very strong illustration in how large the momentum is with surgeons. That also is maybe answering the other question you asked, what are you getting as feedback? The overall feedback is optionality. The fact that the surgeon can choose and that there is an alternative or that there is a second, we like to call it a better option than what is currently available. That means just having more therapies to treat OSA using neuromodulation or HGNS. That is the overall feedback. Continuing on the leading indicators, sites, surgeons, the next one then would be the number of VAC committees in the U.S., Value Analysis Committee. We have over 100 already submitted. Half of them are approved. We have no rejection. The reason why we have not everyone approved is simply it is a time issue because sometimes they meet every month, some meeting every two months. It is more a time issue than something else. After this, another indicator will be pre-authorizations. As you know, we are working with pre-authorization submissions to healthcare payers. We are measuring this as well. The last leading indicator would be surgery time or OR time scheduled for actual patient implants. That is what you can expect from us going forward. Those are great statistics, and I'll take them. I appreciate that, Olivier. Maybe just one that really popped out as you were going through them. I had here what I was going to guess, okay, if you were not willing to provide those metrics. And I had over 100 ENTs, and you said, I think, 121. I had down at 20 VACs. The 50 that you gave is an impressive number. Just to be clear, those are facilities that are sort of ready to go. I mean, they are all set. You have gone through. Surgeons trained, VAC done, and now the next thing is patient identification and then pre-authorization submissions. Okay. So let's talk a little bit about that patient identification. Maybe tell us a little bit about the type of patient that's opting for Genio. Is it they don't want an implant? Is it the ENT was looking for bilateral stim? Are there any sort of commonalities that you're able to identify between the typical Genio patient? Yeah. You are touching, I think, on the most important question that we will need to solve, not only Nyxoah, but also our competitor. It's like, what is now the best patient phenotyping? If you allow me, John, I would like to elaborate a little bit on this one. First of all, when our commercial team is talking with physicians, how do they position Genio? First bucket of patients they go after is the low-hanging fruit. You have up to 15% of people today that are saying, "I do not want to have a battery implanted if it's not needed." I mean, it's low-hanging fruit. That's also this optionality. There is a second choice now. There is an alternative to a pacemaker platform. That is the easiest bucket, up to 15%. The second one, and I think very important, is I call it clinical differentiation. Because in the end, we are treating patients, and I do think robust clinical evidence is needed. We always had in our vision make sleep simple and do it patient-focused. What we mean with this is a patient or a physician should not be worrying when his patient or her patient is sleeping on his or her side or on the back or on the tummy. It should always work. We are the only one with proven clinical evidence for Positional OSA or proven evidence that our technology is showing the same result when you sleep supine versus non-supine. This is a big one. That is the second bucket. The last bucket is the ones that patients with sleep physicians that we identify quitting their CPAP, being eligible, moderate to severe. Okay. Got it. Very helpful. Are you seeing, call it, pent-up demand or pre-existing demand? Because there were prospective patients who went through, had the DICE, but then sort of said, "Oh, I don't want the implant," or found out, "I don't want the implant," or they were sleeping supine. As you go out and the commercial efforts start to ramp, are you sort of seeing any pre-existing demand that was already out there for you to tap into with your solution? Yes. The short answer is yes. That is also when we train surgeons and they want to be part of our training program, we also ask them to come with minimum three patients that we can discuss patient cases. We also offer them to come together with their sleep physician if they are already partnering very well. We run two programs in parallel. One is the surgical program where we do cadaver courses, implants, and all these. In parallel, the sleep doctor is also trained. For example, what is his or her role post-surgery? If there is a titration needed, if there is a patient activation needed, what is their role in this? How can they, for example, do a follow-up if the technology is working effectively? We all know you have home sleep tests that are pretty advanced. Is it not time to say for a sleep doctor every six months, should we not do a quick home sleep test? The sleep doctor can read out the data. It's also economically beneficial for him. It's a little bit more worry than just a patient consultation. It provides us also great learning because we then can see after six months, after 12 months, how are our patients doing? We want to continue learning. We want to continue investing in order to even further increase and increase the overall response rate. A couple more questions, and I want to bounce into reimbursement, which does seem like a hot topic, but maybe talk to us, Olivier, in terms of what you're seeing from a proficiency standpoint. I know it's still early, but we've done past work on Inspire, and you saw the surgical treatment times come down considerably after X number of procedures. Yours is a different type of procedure, obviously, with the power external. Talk to us about those early surgeons that have done probably a handful of procedures and their corresponding treatment time. Are you seeing it already start to come down a little bit? Yes. What I would like to highlight is that we are already more than three years in Europe. Today, if you look at the number of implants we have done, we passed 1,000 implants. It's sometimes a number that everyone seems to forget because everyone is focused on the U.S. launch. It's no longer that we have done a handful of implants. We have more than 1,000 patients. Our longest patient is already implanted more than six years in Australia. It's a lady. She's doing great, by the way. When it comes to procedure time, yes, there is a learning curve, obviously. What we are seeing is that first two, three patients, more or less one hour and a half, and then it starts ending up around 60 minutes. We have now seen our fastest implants done in Germany with Dr. Beckendorf. It's the one who has done more than 75 implants himself, and he did the fastest one in 32 minutes. It is not about only speed, but it stays quality, but we can say, let's say, 50-60 minutes. It's the time once you have it in your fingers, to say it like this. Let me touch on reimbursement. I'll sort of bounce off the balance sheet, John, bring you in a little bit, and then we'll maybe pivot to Triple C. On reimbursement, there's always a good amount of chatter, and I'll opt for that word, chatter, and Nyxoah's ability to use 64568. I'm just going to keep it sort of open-ended and flip it back to you, Olivier. So far with the U.S. launch, what you're seeing in terms of 64568 and what you've experienced to date, call it from both Medicare and the commercial providers? Yeah. First answer is we have not received any rejection. All the submissions we have done, being it to Medicare or being it to private payers, they all have been approved. I think that is a confirmation. John, feel free to step in. It is a confirmation that this coding is accepted also for Genio. That is step one. I think second, if I can do some name dropping when we talk about private payers. Blue Cross Blue Shield, Anthem, UnitedHealth, Cigna. I mean, those are important ones, and they all accepted the 64568 code for Genio. I think that is really crucial in going forward, also for the hospitals, for the physician. We are extremely excited. As I was saying from the beginning, and I was heavily challenged on this, but sometimes it is nice to be second. I mean, all the heavy lifting was done. There is a code for Hypoglossal Nerve Stimulation. There is not a code for a company. It's for Hypoglossal Nerve Stim. And if you have the same mechanism of action and you have your patient phenotyping also in this area that is known by payers, you get reimbursement. You're not getting pushback from the payers of, "Hey, this isn't an implant that sits inside the chest wall or anything like that." They are focusing on the Hypoglossal Nerve Stim component, and you're seeing approval from, it seems like it's safe to say, an array of different commercial providers. It is totally correct. If you read the definition, it talks about cranial nerve stimulation, and the hypoglossal nerve is cranial nerve number twelve. It is thought also by activating a cranial nerve stimulation through a pulse generator. That is what we do. I might add the cycle times too for that process from pre-authorizations to approvals is roughly two business weeks. Then on the post-implant side, the approvals for payment are generally running roughly two weeks. It is running very consistently and running very efficiently now that we're through these processes. That's pretty consistent amongst the different commercials as well. The two weeks from prior auth to authorization. Correct. Okay. Very helpful. John, maybe I'll stick with you. This might be for both of you guys. Funding the launch is obviously very important. Maybe, John, you want a level set of where the balance sheet is, the burn, and then just the plans going forward, right? You want to expand. You want to step on the gas. There is a number three player that probably comes to market sometime soon that we'll get into. Maybe we can start there. Sure. Yeah, absolutely. As we had, first step we took is as we had an FDA delay to get to the August timeframe, the first thing we did is took a sharp look at our investment levels on the OpEx side to see where we were making our investments. We really concentrated those investments in the U.S. commercial launch as well as on innovation. We have taken a very sharp focus on that and diverted all the investment levels essentially there to focus on those two key priorities. In terms of that, that has helped knock down our cash burn during this period of time. From a financing perspective, on top of that, we are looking at a variety of options to fund the business to fund the U.S. commercial launch very successfully. I think there have been a couple of schools of thought that have been out there in terms of capital raises that need to take place, fund the business all the way through to profitability or fund the business to be able to demonstrate four to five quarters of commercial success in the U.S. I think in either scenario, we're going to be raising capital to go fund at least four to five quarters of U.S. commercial success here and make sure that we can go demonstrate that all those key leading indicators that we're tracking, we continue to see those going up and to the right. As time progresses, we're able to backstop that with U.S. revenue that we're generating in an upward trajectory as well to supplement that. Yeah. Maybe also on top of this, we also are making very specific investments in keeping the innovative leadership. I think it's so important, again, in putting the patient first. It's so important that we also invest like, how can we, for example, continue increasing the response rate in patients? Because as you know, today with Hypoglossal Nerve Stimulation, we see it going up to end 70, beginning 80% already, but there is still 20% that is non-responding. How can we solve this? There we are collaborating with Vanderbilt University and with Dr. David Kent. We're also making good progress. To your point, that won't be compromised. You'll keep your focus on that and push that ball forward. Okay. Very helpful. You mentioned I'll go through the Triple C opportunity because you mentioned something interesting in terms of maybe funding the company for four to five quarters, showing the U.S. commercial success. From my seat, that's where you might land on Triple C, which we did a recent report. I think that pent-up market opportunity is much, much bigger than investors realize. We'll go ahead and try to put some numbers to that. Olivier, remind us where you are with the Axis trial. I think you recently stopped enrollment. It would be plus 12 months. Could you be there with a label for Triple C, late, late 2026, early 2027, which would correspond to the four to five quarters of funding? Maybe if you could talk to us on that timeline for Axis. Yeah. So what I learned from my recent experience with FDA is that I have to be extremely careful when it comes to timeline projections. No, but to your point, we stopped the enrollment end of July. So then you have the 12 months. It will bring us 26, let's say July, August. Then you do your analysis in the month of August, and then we would do a PMA supplement submission. Normally, yes, this takes three, I already learned, let's say three to six months, and that would put us in Q4, Q1. Q4 or Q1. No, John, what I would like to, because when you talk about CCC, and maybe I sound like a broken record, but I would like to come back, our mission is make sleep and our vision is make sleep simple again. Again, it's the same thing. Why CCC? We want to offer a technology to physicians that you don't worry in what sleep position, supine or not. You don't worry how complex your airway obstruction is, lateral wall collapse, complete concentric collapse. When you go for a technology where healthcare payers are paying good money for, I think you also have a responsibility as a company that you can offer something that is helping all these patients in a correct patient phenotype segment. That's why CCC to our bilateral stim is also another differentiating factor. Very helpful. To push you a little bit, do you think you're first there or there's going to be another company, LivaNova? It seems like Inspire is taking a different approach and then almost by their own admission won't be there with their Triple C solution for some period of time. LivaNova is looking for approval. The trial design is a little bit different. I believe it's inclusive of Triple C patients. Even when you get there via Axis, do you think you're first to market with Triple C or do you believe LivaNova might be able to have that on label upon their FDA approval? Yeah. So it's a little bit difficult to answer the question because the communication of LivaNova on where they stand, I think there are still quite some questions that are unanswered. That makes it for me also difficult from a timing perspective to say something that makes sense. On the other hand, you touched on something very important again by saying Inspire takes a little bit of a different position. The way we are looking at HGNS is you will have pacemaker platforms, Inspire and LivaNova, and you will have non-pacemaker platforms. We like to call it more innovative platforms where we are leading and where we are alone at this moment. Now, again, our vision in going forward, we see obstructive sleep apnea as chronic disease management where the patient is crucial. We invested a lot in patient application. We will also so that patients have their app, that they get ownership about the technology as well, that they can have access to scalable software programs like we see with our phones. There is a new upgrade. We would also like to push this through because we do believe that who can own the patient with this technology and offering this will also have the best results, the highest compliance, and will have the future. Therefore, we see pacemaker platforms versus what we are doing being totally differentiated. Very different and standing alone. Okay. Very helpful. A few more for me. I mentioned we did some work on Triple C recently. Should we all sharpen our pencils there? It seems like there's been a lot of patients, and Inspire has helped sort of aid this process through a lot of direct-to-consumer dollars. That have gone through the process, they've gotten the DICE procedure, they look and feel highly motivated to get the procedure done, and then 30% of them might kick out, right? Because they have Triple C. You can sort of backwards engineer the numbers and sort of look at the number of implants that Inspire has done. If there's a 30% rejection because of Triple C, there would be a really sort of fertile patient population awaiting a solution. Is that fair, Olivier? Do you view it similarly? Do you think 2027 and 2028 could be big Triple C numbers in terms of implants, and that might await the first two players that get there with an on-label indication? No. Yeah, the answer is yes. Even take it one step further. Today, you have this examination, the drug-induced sleep endoscopy DICE that needs to happen to exclude or to identify Triple C patients. It is not only the patients that suffer from Triple C that you will help, but it will also create a new dimension, meaning that the moment a surgeon or a physician is seeing a patient that corresponds from a BMI perspective, that corresponds being moderate to severe OSA, there is no examination needed anymore. They will go straight to implant. No, there is always this stop in between that will vanish. I do think it can be really important and have a lot of impact. Remove that hurdle and it just simplifies the entire process. Correct. Okay. Okay. Okay. A couple more topics. I'll jump to GLP and then I'll go to next generation and where you want to. I was waiting for the GLP question. I was looking at that. Look at it. I made it too quick. Because I need a little bit of time for the GLP-1, so I'm happy that we still have five minutes. I earmark some time for it. A lot of chatter around GLP-1s and the headwind, but maybe future tailwind and the net number. Maybe I'll go with level setting everyone again. Your label's different. Your label's 32. Your label's not 40. You didn't, I want to be respectful when I say this, chase the upper limits of BMI as your competitor did with a label expansion. Now I'll flip it to you. What does that mean for GLPs? And are you facing less of a headwind because you never sort of went upstream to the BMIs of 38, 39, and 40? There was a lot there to unpack, sorry. Yes. No, no. This is one of my favorite topics to answer. First of all, as we were saying from the beginning, everything is about patient. Patient management, setting the correct expectations, and showing good results when you get an implant. We are convinced that today, by limiting your BMI to 32, which by the way is a heavy, severe, heavy obese patient, it's not that you are a feather-light person when you have a BMI of 32. By limiting it to 32, we know that we can show great results expressed in response rates, as I was mentioning, expressed in HI reductions from 65 all the way back to below 10. There also, we are at 82%. That's what we want to do because I do think this is crucial when you're building a new technology or offering a new treatment. By the way, I will name them by name, Inspire, they were thinking exactly the same when they did their START trial. They also had the BMI limitation at 32, and they showed also very strong results. That is the starting point. Now we have GLP-1s. In the Sermon trial of Eli Lilly, the average BMI was 37. There is a clear correlation with AHI. It was 49, 49 or 50. What you saw when patients respond well to a GLP-1, they had a 25% BMI reduction. The 37 became 28. They had 40%-60% reduction of AHI. The 49 became something 22-26. Those patients, we would never, ever be able to capture if they would not take a GLP-1 and would still be in need for OSA treatment. We see GLP-1s, we welcome it. We see that's something very positive because it brings more patients into our segment. Now, more important is also the fact that we see, again, chronic disease management, you need to show a little motivation. If you have suffered from OSA, you need to show a little bit that you are willing to lose weight when you have a BMI of 37. It's a lifestyle change that will also need to happen. By sleeping better, by giving and getting your nights back, it's like you're breaking the circle of, "I'm not feeling well when I wake up. I am tired. I fall asleep during the day, but I'm still eating a lot. I'm still drinking a lot. I'm overweighted." You have to break the circle. GLP-1 in combination with Genio will also help patients that today cannot be treated. Now, our competitors, they were saying, "How can we expand the market?" It is clear if you go with those high BMIs that you find a lot of OSA patients. It is obvious. We have chosen to expand the indication by offering solutions for more complex airway obstructions, positional CCC, you name it. It is a different view. I am happy that we chose our view. Yes. Because what are you seeing today? When GLP-1s are available, you see that people are saying, "Let's wait a second, see first if this is working before I get surgery for having a pacemaker implanted." Once it is working and they are coming in the segment where we are, then there is competition for the first time. I really welcome GLP-1s. Sorry that I took four minutes, but I hope I was explaining it in. All good and very clear on why you believe strongly in net tailwind and also exploring other ways of expanding the market via positional sleep and Triple C. Correct. Okay. We do have one minute left, so I'd want to end, and maybe it's a good way to end. Just next generation for the technology. When I speak to investors, respectfully to the investors, it's a little bit of a lazy pushback, but it's, "Oh, you know what you have to put on at night, and is that a barrier?" When you hear that sort of feedback, how do we think about where this device can go? Can you power it bedside? Do you have to put on the attachment, if you would, at night? Where do you want to see the implant go over the next two to three years? Yeah. Very short. If you really put the patient at the center, there should be no wearable component attached to the body. There should be no button to push, nothing. You should have intelligent systems where you incorporate self-learning. Artificial intelligence is now the buzzword, but also in our technology, this will be incorporated. When you look at Genio or implant, it's already there. It's passive. It is an energy transfer through induction. We don't need to have the activation chip under the chin. We can also have the activation chip, for example, in the pillow or what you see when people are wearing on a plane when you do something to sleep better. Then you have your power source on the nightstand or in your pocket or wherever it is. This one we are also investing in. I even can, in the last 10 minutes or 10 seconds, I can even say that by 2030, we do expect to be able to offer this also to our patients, having no wearable component with self-learning intelligent systems. Great way to end. Olivier and John, thank you very much for your time. Thank you for the questions. Thank you.