Good morning, everyone, to the first day of Oppenheimer's MedTech and Services Conference 2026. Our first company on our schedule today is Nyxoah. On a lot of people's radar screen, this is your friendly host, Suraj Kalia, Senior Medical Device Analyst at Oppenheimer. Olivier, John, thank you so much for taking the time and kicking us off this busy conference. Lots going on in your space. I'll let you take the floor, and I'll resurface five minutes before the end. Okay. First of all, Suraj, thank you for the invitation, as usual, and thank you for offering us the stage also to talk where we stand currently with Nyxoah. Let me start by reminding everyone on the vision. Nyxoah, a med tech company, active in the treatment of obstructive sleep apnea by offering a neuromodulation solution. Our vision is to make sleep simple again. Most recently, we had the pleasure also to obtain FDA approval and start launching our product actively in the U.S. I will come back on the first launch results in later in my presentation. For those who are new to the story, maybe just a quick update. If you look at the market of obstructive sleep apnea, it is a huge market with roughly $10 billion market opportunity in the U.S. alone. It's referred to as a blockbuster market. In the market, it's highly under-penetrated. There is only one company, and since we have obtained FDA approval in August last year, we are now actively launching as a second player. I will run you through our technology. We have a total differentiated patient-first technology with a unique bilateral mode of action. It's all backed up by robust clinical evidence in our pivotal study. Of course, we also are showing a very strong safety profile from the Genio system. We already have implanted over 1,000 patients in Europe. We are commercially reimbursed in Germany, in the U.K., in the Netherlands, and also in the UAE. Since August, as I mentioned, actively launching with a dedicated Nyxoah U.S. commercial team. We also have a U.S. reimbursement code, a CPT code, but I'm sure that there will be quite some questions since this has been a hot topic lately, but I'm also happy to provide more clarity on where we stand on this. Now, in a nutshell, looking back, why do people suffering from sleep apnea need treatment? It is very straightforward. If you suffer from sleep apnea, you get obstructions of your upper airway multiple times during every hour throughout the night. Each obstruction is creating a lack of oxygen, and that is increasing mortality. This comes associated with an increased risk for comorbidities, like your cardiovascular risk goes up by five, risk of stroke doubles, risk of heart failure goes up almost 3x. That's what people that are not treated can die from. There is also a high prevalence in all chronic diseases. You can see them all listed. I'm focused on one that is type 2 diabetes, where you see that up to 72% of all diabetes type 2 patients also are suffering from obstructive sleep apnea. That's also why in the vision of Nyxoah, making sleep simple again, we're also actively exploring how we can help by reassuring and by managing, in fact, chronic disease management for those type 2 patients as well and play a positive impact in stabilizing their glucose levels. That is for later in the presentation. For now, I think important, a unique bilateral stimulation. You treat OSA because of the risk of comorbidities, more especially linked on the cardiovascular, heart failure, and stroke risk. You see also that there is a classification of intensity of OSA. We are focused on moderate sleep apnea and severe sleep apnea, meaning minimum 15 obstructions every hour and going up all the way to 65 obstructions every hour, what would make you a very severe sleep apnea patient. What are the current treatment options? On the left, you can clearly see the standard of care. It's the CPAP device. It's a very highly efficient technology and therapy. The only issue is that you need to use the therapy in a very compliant way. In literature, it's stated that a lot of patients are suffering from this and that the CPAP non-compliance ratios can go up depending on how long people are taking this, all the way from 30% all the way to 80%. It works well, but patients need to be motivated and need to be compliant. With a high dropout of this, there is also a clear need for an alternative. What do we have? It goes from mandibular advancement devices. They are more focused on mild to moderate OSA patients. They are not so predictive from an efficacy perspective, and they come also with a high out-of-pocket cost for patients. Of course, there is the unilateral hypoglossal nerve stimulation. That is the competitor that we are competing with in the market in the U.S., but also globally. We see that they are suitable for moderate to severe OSA, but the downside of this technology is that it comes with multiple incisions with an implanted battery that needs to be replaced and still with some MRI compatibility restrictions. There is, of course, as a final option, still the traditional surgery. It is highly invasive. Success ratio is relatively minimum. We also see that there is a high incidence of side effects, and it's a very painful surgery that will also reoccur. We see that mainly the newer generation of ENT surgeons are staying away from this palate surgery and are more focused on as an alternative for CPAP using hypoglossal nerve stimulation. Now, let's jump into Genio and start talking about our technology. We have a technology that is completely differentiated compared to a pacemaker platform. How is this differentiated? It starts with an implantable component. That is minimally invasive, a single incision under the chin done by an ENT surgeon. There is no implanted battery. It will offer a bilateral stimulation left and right. Why is this so important? Because this will result in a stronger airway opening and will also enable patients to treat obstructions that are more complex. I will come back to this later in the presentation. Just to already name one, in our vision in making sleep simple, it's crucial that when a patient has the Genio technology and therapy, that they are protected throughout the night. We are the only company at this moment that can offer an effective therapy also in a supine sleep position. Why is supine so important? Because when you go on your back during the night, you see that the number of obstructions can significantly increase. It can even double. If it doubles, we are talking about positional OSA. What we are seeing with our bilateral stimulation is that we remain efficient also with those patients. That is crucial in the selection for a physician in what they are offering when they see an OSA patient. We have no implanted battery, so there is no need to replace our battery. We also have no leads or no wires connecting our electrodes, so there is also no risk of having lead fragments. First component, the implantable part, it is done by the ENT surgeon under the OR, 60 minutes skin-to-skin time. That's the average time we are seeing. No battery, full body MRI compatible for 1.5 and 3 Tesla since it's a passive device. That brings us to the next component, and that is the smart sleep wearable. This is the wearable that goes under the chin, as you can see on the picture. Before a patient goes to bed, they connect the wearable component with an adhesive or a disposable patch, put it under the chin, go to sleep. The wearable component, it is first of all activating the passive implant by transferring energy through induction. More important, it also has the intelligent control of the implant, and that's what is making it smart. This is predefined in settings that will be unique to the patient that is using the device and that will also maintain the airway open throughout the entire night. In the morning, of course, the disposable patch is removed, and the wearable sleep component will simply be recharged to be used the next day. Next to the implant and also the smart wearable, there is also an intuitive patient app, and this app is doing three things. First of all, it's monitoring sleep data. Important also to provide live feedback to patients when they wake up. It has definitely an impact also on increasing or helping patients to be more closely involved with their technology and get direct information how well they slept. It is also giving the patient with an option to personalize the stimulation settings, of course, within predefined boundaries by physicians. The patient can play a little bit and adjust the stimulation, finding his or her optimal comfort. It does also a lot of data capturing that can be used to build health economic data that can help the physician to better manage the patient. Over time, that gives us also information that we can feed back to healthcare authorities in order to make sure that we can further expand or also definitely demonstrate with data how well patients are doing and how effective this also is from an economic perspective. Last, when an OSA patient is traveling or just going somewhere, they don't need to carry anything. It's just a very simple rechargeable component that you can put in your purse or in your back pocket. It is travel friendly. There is also the implant for life concept, meaning that once you're implanted, you know you will have a longevity already proven of 12 years. That is also incorporated in the label. I think important and last to mention, we have a scalable technology platform. Since the software is external, when we have an upgrade, we can simply push it through like most of the people are used with their smartphones. We can do exactly the same thing. A Genio implanted patient will always benefit from the latest and greatest upgrades without the need of re-surgery. High level of clinical evidence, because since we are a med tech company, we do find clinical evidence and the development of it is very important. We have our DREAM study. It's a pivotal study that resulted in FDA approval, and I just will walk you high level through the outcomes. If we look at our endpoints, more specifically the primary endpoints, we see a 63.5 reduction in AHI, meaning that the responder rate is defined as patients where you see the number of events minimum being reduced with 50%. On top of this, the AHI needs to be below 20. We also see an ODI or an oxygen desaturation responder rate of more than 70%, 71.3 to be very precise. From an adverse events perspective, it's a very safe technology with on average 8.7 severe adverse events. You can also see how they were categorized by an independent panel reviewing all the severe adverse events. The conclusion on this one is we definitely met all the primary endpoints. We are highly efficient, and we have a very safe device that we can offer in patients in going forward. What I also always would like to highlight is within the responders with Genio, you see that on average we were able not only to reduce the AHI with fifty percent, but overall the median AHI reduction was reaching 71% after 12 months. Important when you look at the same thing in a supine position. Once again, as a reminder, we are the only company with data on this. We see that the technology more or less stays at the same high efficiency level. If you look at number of patients where we can bring them with their AHI below 15, and meaning less than 15 obstructions every hour, resulting in a stabilizing factor from a comorbidity perspective, 82% of the Genio patients or patients implanted with Genio will return with an AHI below 15. I do think, if you compare this makes us unique, totally differentiated, but also is very reassuring for physicians in their selection and for patients in their acceptance of a technology. Let's jump to the commercialization. There are the international markets. I already mentioned Germany. U.K. is another large market where we obtained reimbursement. We use a smart follow technology, and we see that we were able to capture in Germany three years post-launch, on average, 22%-23% market share of the hypoglossal nerve stimulation market, which gives us a lot of confidence and a lot of learnings also entering the U.S. market. I do think with this audience today, I wanna focus on the U.S. commercialization strategy and also share the first results that we see after the first full quarter post-FDA approval that we had during our Q4 last year. Our strategy is very straightforward. We focus on all the high volume hypoglossal nerve implanting accounts since they are representing roughly 70% of the total HGNS volume in the U.S.. It is a very concentrated market, roughly 400 sites are generating 70% of all the high volume implants. When we launched, we already had a dedicated Nyxoah sales team. We have an organization, a commercial organization in the US of roughly 60 people. Of the 60 people, we have 40 sales reps or category managers. All of them, they are focused on average, five of those high-volume implanting accounts. We have to back them up also a dedicated market access team that is supporting with the reimbursement submissions. We have a marketing team and also a field training and education team who are doing a wonderful job at this moment and where we are also seeing that there are even waiting lists for surgeons in the U.S. that are reaching out to us to be trained. Next to the ENT surgeon, there is also a referral strategy with sleep physicians. On this one, we also differentiate from competition, where we do not invest hundreds of millions in DTC, but we are very focused on the CPAP-quitting patients, offering them a solution, and making sure that sleep physicians find their way to the Genio centers, where they can send their CPAP-quitting patients with mild to severe OSA and offering them a solution to continue protection and to keep them protected also from all the comorbidities. What would happen if they would result in untreated OSA patient? From a reimbursement perspective, and I'm sure there will be quite some discussion lately also with and quite some questions because there was some unclarity created. When we launched, we had CPT-recognized codes by both Medicare and private payers. We were able to secure payment with, I, to name some of the larger names of private payers, UnitedHealthcare, Blue Cross Blue Shield, Anthem, Cigna, and we also obtained coverage by CMS. I'm sure that with Suraj, we will dig a little bit deeper in the Q&A on the current status. Also here, I can guarantee and tell as a takeaway message, when we were entering the new year, January, February, we see that a continuation of reimbursement is happening. We had the majority of all our cases submitted, also approved. For private payers, we did not face any issue. With CMS, we were seeing that there were some changes that were taking place. The more the time is advancing, the more clarity we're also seeing getting there. Our path forward, it's not, of course, the focus is launching in the U.S., and that's what we are doing. All our focus is on the U.S. launch. We continue also investing in making our technology better in innovation. In the second half of this year, you can already expect a launch of a new wearable component. There is also, in the second year, in the second half, besides the launch, also the first upgrade of software that will be pushed out to all patients that already are implanted. From an international perspective, we are very selectively in geographic expansion. We already touched about the UAE, and we will also be looking at Singapore as a first entry point to detect and to discover where our technology will be embraced, entering over time into the Asian market. With this, I wanna conclude my presentation and open it up for further questions. Just as a reminder, it's a huge market, and it stays a huge market in the U.S. We are entering as a second market participant, and we broke a single company dynamic. I think that's really important. Our technology totally differentiated, and we provide optionality to physicians, and that is something they were really waiting for. I can also say that we moved into a robust commercial success company with more than 1,000 implants already in Europe. When it comes to reimbursement, we have our reimbursement, and this will continue, although I'm sure that Suraj is burning to fire off some questions on CMS when it comes to reimbursement, and I will wait and then ask his questions. Thank you. Suraj, I'm all ready for our conversation. Olivier, John, thank you so much. Olivier, first and foremost, congrats on all the progress. You know, like we have written, and I think so the street is generally talking about it, there seems to be a lot of chatter about Genio interest from the ENT surgeons in the field. You know, I appreciate you giving us some color there. Olivier, to the extent that you all can, and John, to the extent that you all can, talk about the 400 top hospitals that you all have always talked about, this is gonna be the main target. Are you in a position to tell us how many of those are quote-unquote already under your belt? 100? 200? How should we think about exiting FY 2026, just from a mapping and a modeling perspective? Excellent question, Suraj. I do think I can provide some clarity. The focus strategy was 400 accounts. With our dedicated Nyxoah team, we were able to cover already 125 out of the 400 right after launch. When we drill down in the Q4 results, that is the first quarter since we had our FDA approval, I'm very happy to share that we already have 119 out of the 125, so where we have trained all the surgeons, and also have done the VAC committee submissions. Needless to explain, but before you can do business, you also need to have the VAC committee approving the technology and that you can do business in the hospital. Out of the 119 in Q4, we already obtained over 70 approvals, and we already did business, active business implanted patients with more than 50 out of the 70 where we obtained approval. That is the status for Q4. I think it's a great status to be in, a great position to be in. We have treated, and we have generated $4.5 million of revenue in the U.S. alone in the fourth quarter. If you look at this, we're working with a limited sales force at that time, going after the 125, having 50 accounts where you can actively do business with. This is giving us a lot of confidence also that Q1 will continue, and we will see a strong double-digit growth. Fair enough. Olivier, knowing that it is early in your launch process, how would you characterize the competitive dynamics, just in terms of the demand for Genio, what do you think is driving demand? Is it physician need or patient need for optionality? Is it the lack of a battery? Is it the incrementally better efficacy in supine? You know, help us understand, what do you see early as it is as your key advantage emerging in the field? Yes. We also did quite some research on this, to quantify this because those are the questions that we also, of course, would like to see answered. No, very straightforward. First, what we see coming back with all physicians that we talk to, interact with, train, do business with, is the fact the optionality. That they have an option, now, and an alternative compared to the unilateral stimulation with offering Genio. And when you quantify this, we learned that up to 15%, so 15%, of all patients that arrive with an ENT surgeon for a device are simply refusing to use a battery-implanted or a pacemaker platform device. That is what we refer to internally as market with some marketing technology as the low-hanging fruit. This optionality, it's something in those high volume accounts that physicians are really pleased about. That's one bucket. The second one in the decision-making process is where we like to refer to as clinical superiority with our supine data already incorporated in the label. Let me also remind you that we finished also the CCC study for another very complex airway obstruction where competition is contraindicated. We will be showing and releasing 12-month data in June this year. We are confident, and we expect that this will result also into a label expansion. Illustrating again that bilateral stimulation, it is different and is showing a lot of perspective also to maintain efficient with more complex airway obstructions. That's the second decision-making bucket. The last one that we're hearing mainly also from patients is that, of course, they like the single incision under the chin, which is very discreet. They know that they don't need to come back after seven, eight years to have a battery replacement. They also know that they can benefit from the latest software upgrades, which always will give them a state-of-the-art technology and also knowing that the risk of re-surgery is simply not there with Genio. Yeah. Fair enough. All fair points. Olivier, obviously reimbursement, everyone and their brother talks about it and wants to know more, right? Yes. My view, for what it's worth, is CMS has created a mess. It is not you guys' doing. CMS just created a mess. Help us declutter this mess to the extent that you can today, 'cause now we have C codes coming in April first. You know, there is discussion about CPT code, but that is for a single or unilateral. Just help us understand how things are evolving specifically on the Medicare side. Yes, I agree. It's quite complex, and there is a lot of unclarity even for us. Before answering the question, I will not go too technical, I just would like you to know that we are now working with our internal team, we are consulting with external experts, and then we are also staying very closely involved in all the discussions that are taking place. Now, my view or our view on this, I would like to start by pointing out that hypoglossal nerve stimulation as a whole just continues to enjoy broad coverage under CMS and under commercial payers. I do think we need to make sure that this message is broadcast across because there is no discussion on no longer reimbursing HGNS. That is not the case. The next thing is you have your commercial payers and you have CMS. From a commercial payer perspective, also there we see that, reimbursement is continuing as usual. They have their contract obligations that they're having, and we continue seeing, approvals and reimbursement and coverage under commercial payers, which is generating more than 90% of the Genio business today. Now we are coming to CMS, and that's where it becoming extremely complex. I do think that we can conclude that CMS understands that it has to start moving towards having dedicated codes for HGNS, because today this is not the case. Also with now entering a multiple technology market, with Genio entering this, there is no longer a monopoly, and there is definitely a need for a dedicated code, both for the Genio technology as for the latest competitive technology. Now, what we saw, and I wanna go back to last Friday because there was an important communication, and I'm sure you saw this, is that besides the fact that there were C codes issued for Genio and for competition, two different codings, there is now also clarity on the APC level 5 mapping and facility fee. That was communicated by CMS last Friday, and we can confirm that both technologies, Genio and competition, is or are receiving $31,526 for their implant, which is aligned with the previous 82 CPT code. I think what is also reassuring us that we can continue doing business, that there is no negative impact on facility fee price, and that both technologies are also being seen as the same level 5 APC at the same price point. That is the latest one. What I think will happen now in the coming weeks, the next thing will be what about the physician fee? What will be there, what will be playing from a physician fee perspective? As we all know, the physician fee was never so, or shall I say, attractive, or physicians were not so happy with their fee. It varies from $660 all the way to $725. What we will see there is that of course it will play a little bit in this range. Will there be a use of a Modifier 52 or not? If so, I do think the physician fee from $725 can become and return a little bit lower to the $660 that was linked to the CPT Code 64568. If there is no 52 modifier use, I do think it will remain relatively stable. Again, the most important thing is there is continuation. Commercial payers non-impacted, CMS providing clarity step by step, and to your point, sometimes a little bit unluckily, I think, in the communication. Since last week, we know the facility fee being $31K, which is very reassuring in going forward, and will also then not, and we expect not to see any major impact on having less patients implanted, while all this CMS clarity will continue and will evolve into a dedicated HGNS code. Fair enough. John, if I could, one quick question for you for the last couple of minutes remaining. John, Olivier talked about targeted DTC. In the limited time remaining, how should we think about inherent OpEx leverage for Nyxoah? Maybe at what level do you think leverage kicks in? Any parameters that, or goalposts that you can provide us to start thinking exiting FY 2026, FY 2027, in terms of the potential leverage that Nyxoah can look forward on the horizon. Sure. Absolutely, Suraj. From a leverage perspective, I think we have a very attractive financial model based upon the strategic nature of our sales organization and the focused launch that we have and the targeted DTC spending. We'll be able to get to revenue break even at about EUR 150 million in revenue. That includes an 80%+ gross margin. We have a very clear pathway with very defined deliverables to get to that 80%, vis-à-vis our new activation chip, which we'll be launching, which removes a lot of cost from the disposable patch, as well as making it more patient-friendly. Two, there'll be pricing in our contract manufacturing agreement that allow us to get to that gross margin at scale. On the OpEx leverage perspective, we've largely built out the organization that we need to from a G&A perspective to scale. The investments that you'll really be seeing, Suraj, are really around the U.S. sales expansion. The 15 sales reps that Olivier mentioned will be one key driver of OpEx expansion this year. We'll have limited DTC spending in targeted accounts to support those 40 territory managers across the U.S. As opposed to, you know, competition that spends roughly EUR 100+ million in DTC spend, our DTC spend will be nowheres near that level, allowing us to get to that aforementioned EUR 150 million revenue profitability level. Perfect. Gentlemen, we are up on time. Once again, congrats on all the progress, and I'm sure we'll be talking a lot more as some of these reimbursement updates and the quarterly calls happen. Again, thank you so much for all the clarity and the insights. We do appreciate it. Thank you for the invitation. Earnings call is on Thursday with more data and more information to be shared. Thank you. Fair enough. Thanks, gentlemen. Take care. Thank you, Suraj.