Nyxoah SA Stock

Good day, and thank you for standing by. Welcome to Nyxoah's Second Quarter 2026 Earnings Conference Call. [Operator Instructions] Today's conference is being recorded. I will now hand the conference over to your first speaker today, Pearson Dennis, Investor Relations Associates. Please go ahead.

Thank you. Good afternoon, everyone, and I welcome you to our second quarter 2026 earnings call. Participating from the company today will be Olivier Taelman, Chief Executive Officer; and John Landry, Chief Financial Officer. During the call, we will discuss our operating activities and review our second quarter 2026 financial results released after U.S. market closing today, after which we will host a question-and-answer session. The press release can be found on the Investor Relations section of our website. This call is being recorded and will be archived in the Events section on the Investor Relations tab of our website.

Before we begin, I'd like to remind you that any statements that relate to expectations or predictions of future events, market trends, results or performance are forward-looking statements. All forward-looking statements are based upon our current estimates and various assumptions. These forward-looking statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. All forward-looking statements are based upon current available information, and the company assumes no obligation to update these statements.

Accordingly, you should not place undue reliance on these forward-looking statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 20-F, which was filed with the Securities and Exchange Commission on March 26, 2026. With that, I will now turn the call over to Olivier.

Thank you, Pearson. Good day, everyone, and thank you for joining us for our second quarter 2026 earnings call. Let me start with Q2 highlights. Q2 was a strong quarter for Nyxoah across multiple fronts, and I'm pleased with the progress we are making in the business. First, the strong commercial execution of our U.S. launch delivered a second consecutive quarter of more than 20% sequential U.S. revenue growth. U.S. net revenue was EUR 5.2 million, up 22% over the first quarter of 2026. We also posted another strong quarter of revenue growth in our international business, up 19% over the first quarter of 2026. On a worldwide basis, net revenue was EUR 7.7 million in the second quarter, representing 21% sequential growth over the first quarter.

Second, before doing a deeper dive on the U.S. commercialization results, let me provide a high-level leading U.S. commercial indicators. Of U.S. leading commercial indicators continued to strengthen across the board. Entering quarter 2 with 40 fully trained sales reps, we can cover 200 of the top 400 high-volume hypoglossal nerve stimulation accounts in the U.S. We have trained 55 new surgeons and activated 89 new accounts in this quarter, doubling our active account base to 180. We entered the third quarter with 427 patients actively under prior authorization, a 77% increase over the prior quarter. Our prior authorization approval rate remains at 100% for both commercial payers and patients submitted via the wider program.

On the reimbursement front, CMS announced meaningful proposed increases for HGNS overall, including Genio specifically. CMS proposed facility reimbursement would increase OPPS facility payment by 12% and ASC, ambulatory surgical centers by 15% for 2027. These increases would further strengthen the economic value of the Genio procedure for the facilities. From a financing perspective, we significantly strengthened our balance sheet by securing $110 million during the quarter, taking away the financial overhang. This new capital will provide us with the resources needed to further accelerate Genio U.S. commercialization ramp and implement the growth initiatives focused on increasing the patient funnel.

Now digging in deeper into the U.S. commercialization. The U.S. commercial launch remains the primary driver of our long-term company success. Our U.S. focused strategy remains unchanged and centered on driving strong Genio adoption in the top 400 high-volume HGNS accounts, which represent approximately 70% of the total U.S. HGNS volume. We hired and trained 50 new sales reps in the first quarter, bringing us to 40 sales territories as of April 1. And in Q2, we had access to 200 of the top 400 high-volume HGNS accounts. Specifically, we trained 55 new surgeons in Q2, bringing the total to 262 surgeons trained on the Genio system. We activated 89 new accounts in Q2, roughly doubling our active account base, bringing the total to 180 active high-volume HGNS accounts.

And finally, we had 427 patients actively under prior authorization submissions entering the third quarter of 2026. This is a 77% increase over the previous quarter. Doubling our active account base to 180 high-volume HGNS accounts in a single quarter demonstrates that both facilities and physicians are embracing Genio and confirms the success of our patient referral pathway by sleep physicians. With 427 patients actively under prior authorization exiting Q2, this gives us firsthand confirmation of increased patient demand and is a key leading indicator for Q3 of the acceleration of our patient pipeline, giving us confidence in continued launch momentum entering Q3.

Next, reimbursement. There is no full clarity for Genio reimbursement with the dedicated Medicare C-code C8011 for Genio. Our commercial payer coverage remains broad and stable using existing CPT codes and our market access team continues to execute strong on supporting prior authorization submissions. Our Genio Access program, we continue to see 100% approval rates of commercial payers, Medicare Advantage and Medicare patients under the wider program. Commercial payers are still the majority of our business, making up approximately 85% of it.

The recent direction of CMS proposed rule for 2027, HGNS reimbursement would positively impact the clinical and economic value of the Genio procedure in OPPS and ASCs. Specifically, CMS is proposing to increase hospital outpatient reimbursement for the Genio procedure under C-code C8011 from $31,526 to $35,414 or an increase of approximately 12%. CMS is also proposing to increase ambulatory surgical centers, the ASCs, reimbursement from $27,563 to $31,722 or an increase of approximately 15%. These proposed increases are amongst the strongest within APC5465, the Level 5 neuromodulation category.

Finally, in the upcoming September CPT Editorial Panel meeting, AAO-HNSF supported by Nyxoah as an industry member will continue the discussion of a comprehensive HGNS. As a consequence, Nyxoah did not submit Genio for a dedicated Category CPT code on the September CPT Editorial Panel meeting agenda.

Let me now focus a little bit more on our recent Investor Day. On July 8, we had the pleasure of hosting our Investor Day, where we focus on bringing together leading ENT surgeons and sleep physicians alongside independent reimbursement experts. The surgeons shared their firsthand implant experience with Genio and both surgeons and sleep physicians confirmed strong airway openings on activation. These real-time experiences are the key drivers behind Genio's adoption in their practice. The reimbursement experts presented their view of the HGNS reimbursement landscape, confirming the durability of long-term coverage and Genio's strong positioning under every future coding scenario. The event reinforced the 2 pillars of our U.S. launch, growing physician adoption and a solid reimbursement foundation. For those who missed it, the replay is available on our Investor Relations website.

International. Before turning to the financials, let's look at the international markets. We accelerated revenue in the second quarter, resulting in a 19% growth quarter-over-quarter. Overall, in the first half of 2026, we almost doubled our international revenue versus the first half of '25, driven by our focused commercial approach in target geographies. In Germany specifically, as the largest HGNS market outside the U.S., we first entered this market back in 2023 as our commercial proof of concept. Resulting today in a stable HGNS market share of up to 25% overall with a market share in our top high-volume accounts of above 50%.

In the U.K., we entered the market at the same time as competition in late 2024. And in our initial accounts, we are seeing market shares above 50% as well. In the Middle East, Nyxoah is the sole HGNS provider, and we continue to further expand. And we recently entered the market in the Netherlands. Our strategy remains unchanged, exercise financial discipline in these markets with a goal of driving growth and breaking even in our international business, which we've been able to do already in Germany.

With that, I will now turn the call over to John for a detailed overview of our financial results.

Thank you, Olivier. For the second quarter of 2026, worldwide net revenue was EUR 7.7 million, which represents 21% sequential growth compared to the first quarter of 2026 and compares to EUR 1.3 million in net revenue in the second quarter of 2025. U.S. net revenue was EUR 5.2 million, representing 22% sequential growth over the first quarter of 2026. International net revenue was EUR 2.5 million, representing 19% sequential growth over the first quarter of 2026. For the 6 months ended June 30, 2026, worldwide net revenue was EUR 14 million compared to EUR 2.4 million for the 6 months ended June 30, 2025, an almost sixfold year-over-year increase, primarily driven by our U.S. commercial launch. Gross margin in the second quarter of 2026 was 60% compared to 57% in the first quarter of 2026.

Research and development expenses were EUR 9.5 million in the second quarter of 2026 compared to EUR 10.1 million in the second quarter of 2025 due to a decrease in product development expenses. SG&A expenses were EUR 15.6 million in the second quarter of 2026 compared to EUR 10.7 million in the second quarter of 2025. This increase was primarily driven by the continued build-out of our U.S. commercial organization. Total operating loss for the second quarter of 2026 was EUR 20.6 million and remained relatively flat compared to EUR 19.9 million in the second quarter of 2025. Please note that our operating expenses in the second quarter of 2026 included a one-time non-cash share-based compensation charge of approximately EUR 900,000 due to the repricing of employee equity incentive awards.

Non-GAAP cash operating expenses were EUR 21.8 million or essentially flat compared to EUR 21.7 million in the first quarter of 2026. Non-GAAP cash operating expenses increased from EUR 19.8 million in the second quarter of 2025, primarily due to the investments in our U.S. commercial organization. During the second quarter of 2026, we secured $110 million in aggregate financing via $95 million equity raise and the drawdown of the second tranche of our EIB loan in the amount of $15 million. This additional cash removes the near-term financial overhang that had been a concern for investors and gives us capital to scale our U.S. commercial business. As of June 30, 2026, cash and cash equivalents plus financial assets totaled approximately EUR 97.8 million.

Now I'll turn to guidance. For the full year 2026, our full year revenue guidance remains unchanged, and we continue to expect worldwide net revenue in the range of EUR 36 million to EUR 40 million. We continue to expect gross margin in the range of 60% to 62%. We now expect total operating expenses in the range of EUR 99 million to EUR 102 million, an increase of EUR 1 million due to the one-time share-based compensation charge recorded in the second quarter. We continue to expect total non-GAAP cash operating expenses in the range of EUR 88 million to EUR 90 million. Non-GAAP cash operating expenses reflect expected total operating expenses less noncash items such as depreciation, amortization and share-based compensation expense.

We continue to target long-term gross margins above 80% and believe our disciplined approach to operating expenses supports revenue breakeven below $150 million in revenue.

With that, I'll now turn the call back over to Olivier.

Thank you, John. As we enter the second half of 2026, our priorities remain clear. First, accelerate investment in our U.S. commercial organization in quarter 3 by further expanding from 40 to 55 territories and implement growth initiatives focused on increasing the patient funnel. Second, continue to execute on our focused U.S. launch strategy, targeting the top 400 high-volume HGNS accounts and third, maintain a disciplined financial approach to OpEx and direct investments towards revenue growth drivers.

Before closing, I would like to thank all Nyxoah employees for their contribution in making the second quarter once more a successful one. With that, I would now like to open the line for Q&A.

[Operator Instructions] First question coming from the line of Adam Maeder with Piper Sandler.

This is Kyle Winborne on for Adam. Congrats on the progress. I guess, first, I just wanted to ask about the quarterly cadence, if we could, with the revenue guidance. Is there any additional color you can give us on how you expect the remainder of the year to break out kind of between Q3 and Q4, obviously, understanding amidst the ramp for the launch that it should kind of continue to grow sequentially. Just -- anything you can kind of help us with there? And maybe you could kind of just talk to your confidence level of achieving the guidance.

Sure. Absolutely. I'll start with that part first, Kyle. I guess with regard to what we see in the funnel with regard to new surgeon training, VAC committee approvals as well as the number of pre-authorization patients are in that position entering Q3. We're comfortable with the guidance for the full year of EUR 36 million to EUR 40 million, which reflects based on our first half revenue, a range of EUR 22 million to EUR 26 million for the second half of 2026. We would expect that revenue in the U.S. to grow sequentially from Q2 to Q3 and then again from Q3 to Q4. And then from an international perspective, we expect it to be consistent in the back half of the year as compared to the first half of the year.

And then maybe just as my second question on the ACCESS study, and we talked about this a bit on the Investor Day. Just wanted to kind of check in to make sure like everything kind of went well. I think you were planning to wrap patient follow-up shortly after the Investor Day, which would have been a couple of weeks ago. And just to kind of confirm if you're still expecting initial data, I think you were saying at or around the ISSS meeting. And if you're still on track for the PMA supplement for Q4 label expansion early next year.

Thank you for the question. And I'm happy to also share here some very positive news. So we are finalizing the 12-month data as we speak, and we are preparing for the PMA supplement submission. For ISSS, we just received the news that the podium presentation has been accepted for the CCC data. So we will release all the CCC data during the ISSS Congress symposium. I invite everyone to attend and to be present. And then when it comes to the submission, also there, we stay fully on plan. So we are finalizing our 12-month data. We are planning to get them submitted end of Q3, latest beginning Q4. Then there is the 180-day FDA review, and we accept as we disclosed already previously, somewhere during the end of Q1, maybe beginning Q2 latest in 2027, a positive result and also CCC added to our label.

Our next question in queue coming from the line of Suraj Kalia with Oppenheimer.

Can you hear me? So Olivier, in terms of your prior authorization cadence, the numbers that you give exiting the quarter, how should we think about the cadence of these prior authorizations? I mean we can reverse engineer some of the implants, U.S. implants that are being done in the quarter. I'm more curious in terms of how much time are you all seeing for prior authorization from start to finish? And is there a specific cadence as the quarter progresses just so that we can map it out for the next few quarters?

Yes, this is a very interesting question. So first of all, with 427 submitted prior authorizations entering quarter 3, just to give some color, this is a significant increase of 77% compared to the number of prior authorizations we had entering Q2. In absolute numbers, entering Q3 427. If we go back in time, entering Q2, we had 241. Now that being said, the next question is how fast can a prioritization result into an actual implant? And I'm sure if you do the math on sales, so we end with approximately 240 devices that were sold. And if you then calculate Q1, we had roughly 240 prioritizations that were transferred in Q2. So is this exact science? No, it's not. But ballpark, we see that the majority, as we consistently communicated that we transfer will also result in actual implants in the next quarter. I hope this is answering the question, Suraj.

And Olivier, our math is suggesting in Q2, you did roughly 240 implants. And I'm curious, out of the 180 active sites, what do you think this translates into your share? Are the 240 just in a certain subset of those active sites really and the remaining really have to -- even though they are active, they have to really start contributing. Any additional color would be great.

Yes. So another very interesting question. So we we're talking about having on average 15% market share in the sites where we are present when we exited, in fact, Q1. We can see that overall, we are maintaining this 15%, but note that we have opened 89 new sites in Q2, which are fresh, which are gaining their first experience. But we can also report that the longest-standing accounts are showing market shares above 15% and I'm even happy to share that our top account is passing already the 44% of market share. And this is really promising. If you see how fast we are opening new accounts and then also if you see how the longest-standing accounts due to reordering and confident in Genio are showing stronger growth in market share than the 15%.

Olivier, one last question, forgive me. Did I hear you correctly, you'll have not paired with Inspire for the C-code submission for the September editorial meeting?

Yes. This was correct. So we are very transparent in this. We participate as an industry partner. We are supporting also the discussion, the lead of the AAO-HNSF, and they are talking about a comprehensive coding. So for September, we continue to support this approach, and we did not submit it for the dedicated code.

Our next question coming from the line of David Rescott with Baird.

I wanted to ask about the new center adds to train new physicians that you have. I think you pretty much doubled the account base in Q2, and that's a pretty significant step-up, of course. But trying to get a sense out of the line of sight accounts, high-volume accounts that you've laid out there. Maybe how or why or what, I guess, we should be thinking about on a go-forward basis, at least in the back half of the year as it relates to the number of new centers you're expecting to bring on per quarter, maybe what that sets you up for into 2027? And then from a utilization perspective, where -- or again, how would you expect utilization to kind of track in the near to intermediate term?

So, David, thank you for the question. And first of all, we have a focused launch strategy focused on the top 400 high-volume HGNS accounts in the U.S. To your point, we showed very strong results in Q2 by doubling the number of active accounts, bringing it to 180. And to answer your question, we have to link this also with the number of territory managers or sales reps that we are having, and we have 40 entering Q2. So, I communicated already a couple of times that on average, our sales reps, they have 5 of those high-volume accounts. So with 40 reps, it's easy mathematics, you can cover up to 200 high-volume sites. Today, exiting Q2, we already have 180 who are active.

Now going forward, -- we also are hiring again a new cohort of 15 sales reps. So that will bring our total to 55. You do the same math. So you see that we can go in quarter 3, quarter 4 up to 225 to 230 implanting high-volume accounts with our current sales force. So that's one thing that we are doing. Now the next thing also asking on productivity in our strategy, the strategy is going deep. And therefore, I'm extremely pleased also to see that we capture overall in all our accounts an average already of 15% market share. But I think more important is that we can see the accounts that were opened up already in Q4 or early Q1 that they are already going beyond the 15% market share and that we already have top accounts where we go above 40% market share.

I mean all this is confirming that facilities, surgeons and patients are embracing Genio. And I think that is the key takeaway message. We are growing extremely fast in the volume of accounts. We also have more than 262 surgeons trained. I mean, again, showing the excitement of surgeons. So, what we expect in the second half, the growth will be more or less reaching 225 to 230 accounts in the second half of '26. And then as we continue investing in hiring more salespeople, this also goes hand-in-hand with having more accounts that we will open. But it's not our strategy to open 1,000 accounts. Our strategy stays to get as fast as we can to the 400 high-volume implanting accounts that we see across U.S.

Maybe just thinking about the other pieces of the guide for the year. To hit the gross margin line, it's a pretty significant step-up in the back half of the year. So, can you help us think through the moving pieces and your level of confidence behind hitting that? And then when you think about this $88 million to $90 million of non-GAAP OpEx expense in the back half of the year, where, I guess, should we be thinking about the bigger incremental dollar spend coming from in the second half of the year? Meaning what, I guess, are you more so expecting to invest behind to drive this broader sales growth versus what's already kind of baked into the core of the business?

Yes, sure. Absolutely, David. Yes. So for the back half of the year from a gross margin improvement perspective, we have ongoing projects that continue to drive gross margin up. These are smaller in nature. For one example, the ES, which is the component of the device that's going to be removed in the second half of the year in the U.S. So that's going to help drive gross margin up to those levels. We continue to increase our yield over the course of the year as we continue to produce products. So those are the near-term drivers for 2026 in the back half of the year.

In terms of OpEx spread, I would anticipate in the third quarter, you'll see a bit of a sequential step-up from the second quarter, but more of the expenditures will be coming in the fourth quarter when we have a full quarter's worth of U.S. sales rep expansion baked into that fourth quarter. So a bit of a step up Q3 expense-wise, but more of it in Q4 to get to that full year $88 million to $90 million number cash OpEx.

[Operator Instructions] Our next question in queue coming from the line of John Block with Stifel.

Joe Federico on for John. Maybe just to circle back to reimbursement for a second. I know you mentioned that you have not submitted for a dedicated code and your competitor seemingly has submitted an application for review at the panel next month. Can you maybe just give us a sense of what your strategy would be like in the range of outcomes if their package is approved or denied -- or just what -- where are you thinking you go from there?

Yes. So definitely. So first of all, I would like to start by pointing out that today, the environment for hypoglossal nerve stimulation reimbursement is stable and supportive and that with Genio, we have a dedicated code, the C8011 that is in place. Also, for commercial payers, we see that there is clarity on the CPT code that they are using, and we're also seeing that we have 100% prior authorization. So that is the starting base. Next, I do think that the discussions that are ongoing in the editorial panel are extremely constructive. We see that the AAO-HNSF is really taking the lead and is also trying to find and to discuss together with AMA finding the most optimal solution for AGL in the future and coming to a comprehensive coding is part of this strategy. If that strategy is followed, the first comprehensive coding clarity would be effective in play January 1, 2029.

Now going back to competition, yes, they went and they submitted in September for the dedicated code. They also did the same thing in April. Just as a reminder, in April, this was rejected. So they have resubmitted. Our strategy with Ingenio stays and remains unchanged. We support the AAO-HNSF, and we do want to follow and give our full support in also going to a comprehensive HGNS coding because there is a coding in play, there is no risk at all. And moving forward, we will see how the future will further evolve.

And then maybe just a quick follow-up. Just on -- you mentioned the 40 trained sales reps entering the quarter and that the plan is to add the next tranche of 15. Maybe just as we sit in August, how is that hiring progressing? And then when do you think those additional reps will be trained and like in the field being fully productive?

Yes. So as I mentioned also in earlier calls, we have a high demand of salespeople who want to join Nyxoah, and this has continued. So, we are currently actively doing the interview process. So we expect that we have all 15 onboarded definitely by the end of quarter 3. We will start doing the training beginning Q4 so that we can still get them active selling even during Q4 and definitely have a full selling and trained sales force of 55 people going in January 1, 2027.

At this time, we have no further questions in the Q&A queue. Ladies and gentlemen, this concludes today's conference call. We thank you for your participation, and you may now disconnect.

Good morning, and thank you for attending the Nyxoah Investor Day presentation. My name is Elisa, and I'll be your moderator for today's call. [Operator Instructions]

I would now like to pass the conference over to our host, Olivier Taelman, CEO of Nyxoah. You may proceed.

[Audio Gap] Nyxoah 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 hypoglossal nerve stimulation, reimbursement. Also there, we were able to have an expert panel in the U.S., reimbursement experts, the JD Lymon Group.

Then we will focus a little bit more about Nyxoah and where we stand, how do we see the market dynamics because there is also a lot of activity recently going on impacting HGNS. 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 2 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 2 hours to ask your questions.

So with this, I will not take it any longer, and I will invite already our Chief Medical Officer, Dr. Mau Boon, together with Dr. Huang and Dr. Jain 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. Jain, can I ask you for a quick introduction?

Absolutely. So thanks for having me. I'm Dr. Vikas Jain. 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?

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 hypoglossal nerve stimulation program.

Dr. Boon?

And I'm Maurits Boon. I'm an otolaryngologist and sleep medicine physician by background. I joined Nyxoah 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 obstructive 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 hypoglossal 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 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?

Yes, absolutely. So for me, I think why add this therapy to our repertoire. 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 2 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 in 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 a lot of kind of support from the company, which has been great to help develop 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?

Yes. It'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. 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 Mau 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 ENTs that I've helped all having good timing with the surgery. Obviously, having to go through that comprehension of this new approach. But I think as ENTs, we're all at least the ones going to this are up to the challenge.

Yes, I 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. To both of you, I'm going to pose the question now. What clinical outcomes have you observed both objectively and subjectively and would you be willing to share a patient story that you've experienced?

I'll go first.

Okay. You can go first.

Yes. I mean I think for us -- I think our practice is largely focused both 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 going to 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, 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 -- 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 was -- she felt more refreshed daily. And so those are the outcomes we're really after, not just does the therapy work, but does the therapy align with the lifestyle that the patient wants to live.

Yes. I'll look at it more globally. We've implanted 22 patients right now. I would say all of them are candidates for both Inspire 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, 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 Genio? And how is the actual process of selection evolved in your practices?

Yes. I think for us -- I think twofold. I mean, 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 3.5 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 do you understand what this treatment is, how to use it? Will it align with your daily life? 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. Not everybody gets surgery. Now when it comes to how I discuss this with patients, it's all about giving them the options. 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 not requiring that incision, the MRI conditionality. Those are 2 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 the future, et cetera, and how you incorporate it and how you'll...

Yes. Again, I think for us -- 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, 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 this is great to add to our toolbox.

Yes. I think it's an evolving cadence and how this gets adopted in different people's practice. I 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? 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% 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? 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-1s were there pushing and helping awareness? Or how do you position this? Do you see a positive impact for HGNS more of an impact where you see it could slow down? 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 and their recidivism rate and then offer them other therapies like hypoglossal.

Yes. I think for us, very similar. 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 -- 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. Mau, I don't know if you have the last question. Just to add also a little bit timekeeper.

Sure. I have one final question, which is really what gives you confidence in Nyxoah as a company and as Genio as a device that will be successful in the market clinically and obviously, commercially?

I mean for me, there's a couple of 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.

Yes. So for me, I think there are a lot of innovations in the sleep medicine space. So it really depends on -- I think what matters more to me is implementation. So that's largely where I saw a huge difference with Nyxoah. 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 community 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, like in patient management, what are the expectations that patients are having coming back? Do they want to be that you call them back every 3 months? Do they want to say, okay, as long as therapy is fine, just leave us out there and then 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, even with my CPAP patients, we see them fairly regularly over the first 3 months. And then once they're compliant, then we generally will see them once a year. So with Genio, we give them similar expectations. Once you get implanted, you'll be activated about 2 months later. Usually, within the first month or 2, we're finding 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 is tolerating therapy, then we'll start this space out. But usually, we then see them about once every 6 to 12.

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 U.S., we are in trial. I will not steal the thunder of our clinical officer, we will talk about the ACCCESS 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% of patients with CCC. Of those that are surgical candidates. Obviously, they've been kind of at a loss up to 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.

Yes. 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, "Hey, look, we see that this works, whether you have CCC or not, whether you're 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.

Okay. 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.

Dave Rescott with Baird. Thanks for hosting this. I wanted to ask about patient selection, right? And when we typically, from our side, think about new products, we think about the patients that are out there that they can go out and capture. And 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, right, who travels a lot or some other patients that are out there.

So I'm curious to hear about how you think about the difference of going after subsets of patients as opposed to saying, hey, this is something that more broadly is addressable to everyone that's out there. And I know that 40%, at least some was that mix that you're seeing today? I mean, how do you expect this mix to shift over time? Is 40% pretty much this bottoms-up number? Or do you think that the technology itself is more broadly applicable to all comers out there?

Yes. 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 compliant 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 parents, 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.

Yes. I think -- I don't think that we're looking at subsets. I think 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, it doesn't matter which center you go to at a year, 50% of patients are still using CPAP and 50% are not.

So -- 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 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 going to have to go in for revision surgery every 7 to 10 years. Do you have a sense of what your health status is going to be 10 years from now? Like, well, if you're worried about that, then maybe we want to consider Genio as compared to the alternative, things like that.

Maybe on the reimbursement landscape today, right? It's less clear than it was a couple of years ago, right? And I'm not as much interested in how those dynamics have played out for you in 2026, but more interested to hear about how that backdrop sets up adopting or being interested in a new type of technology like Genio, if there is, again, improvement in what reimbursement clarity looks like at a certain point in time, does that maybe open the floodgates more just toward being able to be interested in adopting some type of new technology versus what you historically have been using a couple of years ago?

I think the reimbursement thing to me is funny, mainly because I'm not a financial guy. I just cut people. I think when I think about the reimbursement landscape, I think about when we started doing Inspire, when I started doing it in 2019, and insurances were still rolling out and authorizing it and people still adopted it. And so we adopted it, we adopted it, kept going up. Insurance has started to follow through and more started having -- 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 blah, blah, all I hear is Medicare was going to increase reimbursement. Everybody just went totally crazy, totally great. And I was just like, 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 -- 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, most providers don't necessarily want to utilize those therapies. But now you have interventions that have higher success rates and are reimbursable. So you're seeing a lot of ENTs that have now said, "Hey, I want to come back to treating sleep apnea again because now I have confidence that I have options for my patients.

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 on 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.

Thank you.

Thank you.

So let's now make the switch to the reimbursement expert panel. The team from JD Lymon, they will be coming in, in a second.

I think I'm hearing them coming.

Yes. Here you are. Joe, Carla, please have a seat. Let me also invite Scott Holstine, our Chief Commercial Officer. So maybe we can start again like we did with the physicians with a brief introduction of yourself, and then Scott has prepared some very interesting questions for you.

Good morning, everybody. Nice to see you all here. My name is Jolayne Devers. I'm a partner at JD Lymon Group. We are a market access firm based out of Minneapolis and the Washington, D.C. 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 then at a very large payer, UnitedHealthcare 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 Monacelli. 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 Jolayne, 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 and Global Head of many start-ups. 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. So -- but combined, yes, we bring a number of years of experience, and it's a pleasure to be here today. Thank you.

Good morning. I'm Scott Holstine. I only have 28 years of experience in the medical device space, primarily in Class III 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 of other small companies in between. And I've spent my entire career introducing new technologies to the landscape. The last 2 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 9 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 do 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 were used existing CPT code, 64568, then they got an additional Category III code to report that additional lead. So they reported those 2 together. When they converted to the Category I code, the 64582 code, that is when they -- I just had -- so they converted to the Category II code and converted quit using the 64568 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 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 is 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, we don't want to be underpaying or overpaying. And so rightly so, they've created these HCPCS C-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 I 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 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 I'd add that.

Yes. 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 influence 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 marketplace.

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 ask -- 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 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 cross-walked 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 of 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 uncertainty. The mechanisms are there. They're just -- they've just changed a little bit, but 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 the 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 thank you for this clarity. We focused 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 HGNS with the specific coding also for Genio. That's one aspect.

As we are a young business, just launching in the U.S., 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 earnings calls, we are in a great position. We have the 100% 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 shifting of chairs, they don't tend to recontract because it's administratively 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 midyear, 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 of things. I would say, first, the codes 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 1-year, 2-year, the rates will be based off of Medicare or the percentage of Medicare they pay above. And then on the coverage side, I'd say we did -- we conducted a payer ad board about 18 months ago now. And just to put an 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 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 6 commercial payer medical directors that we talked to.

So it's very public information that Inspire is pursuing their own CPT code. So how should Nyxoah 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-HNS and specialty societies play a really important role in the CPT Editorial Panel. They are advisers. 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 respected that. 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...

I think -- I'll make one more quick. Sorry, I didn't. Even if, let's say, that application would go through, remember that the code still exists today. It doesn't orphan Genio in any way. It provides perhaps more granularity, again, introducing another code, but it doesn't orphan the Genio procedure. We still have 64568, 64582, whatever the clarity will be that will come out for January, but it doesn't change anything here. And the panel is 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.

Yes. 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 AAO and 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 throw out of clarity and also following the advice of experts, we do believe that collaboration is better than trying to do your own thing.

And why am I saying this? If I remember correct, also the previous submission for Inspire for dedicated codes for Inspire V, it was rejected during the Editorial Panel. So now 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 Genio positioning in this because we have a totally differentiated technology from a surgical perspective.

So the CPT codes again exist to report procedures, not necessarily technology and devices. And that -- those procedure codes exist today. We will get further clarity, I think, from the CPT Editorial Panel 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, Olivier, 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 billed 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 side. 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. Scott, I know that maybe you have some further questions.

I would like to have questions from the group.

Perfect.

Be kind.

Yes, I'll ask a couple. Maybe first, there was an initial submission by Inspire, right, for coding in the Editorial Panel, and I guess it got rejected, right. So based on your understanding, why could that have happened? Why would that have happened? Two, when you think about the potential now for September, what would CMS consider when they are deciding whether or not to now decide to accept this new coding?

And then three, when you think about getting to the RUC panel and what those rates potentially could be versus what we have today, there is, of course, the absence of an IPG, the inclusion of an IPG, why not should those physician reimbursement rates be similar if there's different components to [the implant]?

Do you want to answer the panel rejection question?

Sure. A lot of questions there. So the panel, I mean, they evaluated there's 5 -- there's criteria for category codes, right? And I think this group is probably very familiar with it, 2 -- at least 2 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 LivaNova also might have a publication. So that may bolster that, if you will.

And then the other part on the RUC, I will say, is that when they go to do the RUC, it will be the AAO-HNS 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 is 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. So I don't see that being an issue.

I would see that being very similar. What was your question about CMS?

Yes. Yes, when you think about the September panel, right, there's these different criteria that they'll consider to establish a code, why, I guess, do you think that maybe this time, if you do think this is the case that we'll have enough now data to get that through, meaning that if there was to be a reason why it gets kicked again or now this 2028 potential is a 2029 potential, what would that look like? And how would that process play out?

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 will definitely be reviewing the literature as well as the other criteria. 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.

Yes. But again, I mean, I want to link it to Genio. So regardless of 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.

Very clear -- even if there's a new code for, let's say, the new form factor, again, they don't delete others in orphan existing technologies under existing CPT codes. That is a precedent 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.

No.

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 will already move into '29. And when we listen to the physician association, the AAO at the next service really important, 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...

A few questions from the live feed. Can you talk about the pathway to obtaining a new Category I 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 I code is the headwind to adoption. Is that correct?

So all the easy questions.

So I think I mentioned that we have been working with and talking with quite closely the AAO-HNS, 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 I. They like to be able to have a little bit of that less biased 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 I 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 AAO-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. I don't know.

Everybody has their own reasons inside, and so I think that is a question for them.

More questions like here, Joe.

Joe, please.

Joe Federico from Stifel. So just to clarify, if the current submission -- sorry, if the current submission is accepted in September, would the plan then be for Nyxoah 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. Like, we do believe in our own strength. And as we were just learning also to do a submission for 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 Jey 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, I cannot make jokes. So no, but maybe we should wait to the outcome what will happen after the first rejection, but one never knows.

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

It doesn't.

Exactly.

And I will just put an exclamation on what you said, Olivier, we are positioned -- well positioned to make a choice.

Exactly.

And we have the criteria in place to do that if it strategically makes sense.

When would the earliest be that the company would submit for a panel if we find out in Q4 that the code has been accepted in September?

So what I would say is whether Inspire's 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 3 each year for the cycle. So February, May and September would be all of 2029.

And the AMA/RUC committee would therefore be in...

The September CPT meeting will have a February RUC.

Right. So if you submit in November for the February meeting, it's now...

May RUC.

Of 2027 or 2028.

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.

Right. But the RUC would be in '27 and not 2028.

Correct.

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

It's about 3 months after the CPT meeting.

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

Correct.

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

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

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

My pleasure.

Thank you.

Thank you. Scott, you stay a little bit because for 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 EUR 7.7 million. But since we are in the U.S., I like also to talk dollars, so $9 million, another milestone for the company.

Then when we dig into the U.S. because that is where our focus lays with Scott and the entire team, so we will start with the leading indicators, then we will end up with the revenue, and then we'll also be a little bit more forward-looking what you can expect.

Scott, I think you are presenting these numbers with pleasure. So...

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, the next 3 months. And so you can see on the slide some of the leading indicators that give us confidence that as we go into Q3 or our first full year of launch that we have a strong confidence in growing at a higher rate in future months, starting with the number of surgeons we've trained. We've trained 262 as of last week, which is up 27% over the first quarter. And probably more importantly, we have increased demand for surgeon training for the rest of 2026.

Every other weekend, we do cadaver labs across the United States. And what we've had to do recently is traditionally, we bring in the surgeons on a Friday and we train on a Saturday morning. The demand is so high now that we have to do 2 sessions on Saturdays. And so starting with our cadaver lab next week, we'll do a morning session and 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 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 3 months. And so we exited Q1 with 90 approvals across the United States. Now we have 180 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'd like to remind everybody, this is -- it's new and it's early. And -- but we're encouraged because these numbers demonstrate progress in adoption.

If you look at the patient side, we've had almost 1,200 unique patients that have been identified by physicians, physicians like Dr. Huang and Dr. Jain. They've brought the patients forward as candidates for hypoglossal nerve stimulation, so PAP failure patients. And of those 1,200 patients, we've had 900 consented into our Genio navigation system. This is important to our company because the Genio navigation system is unique to Nyxoah. And when a patient consents into our navigation system, they are allowing us to manage their patient pathway. And the physician offices like Dr. Jain that we work with love this because instead of their staff having to work through navigating the patient, the navigation center does that. And you can see that's a 62% increase over the first quarter.

And then finally, and maybe most importantly, since we just came out of the reimbursement conversation, we have 427 patients in prior authorization, which is a 77% increase quarter-over-quarter. And so when we look at looking -- predicting the future of Q3, we're at a much stronger and a larger foundation than we did coming into Q2. And then finally, at the bottom, we did a backwards analysis over the first 6 months. So this doesn't include Q2. This is just in Q1. After Q1, the first 6 months, we had already accomplished a 15% market share in accounts where we had launched Genio since 2025. So these are objective measures. If we go to some subjective measures.

I will let you 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 hypoglossal 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 ended 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 truly impressive, and it gives us a lot of confidence. So I don't know before we go to the next slide, if you have any questions on this because I do think it's important that the numbers are well read and interpreted. So if there are questions on this one, maybe it's a good time.

David, I'm sure you have a question.

I believe there's a difference in -- we have the net revenue, right? There's difference in gross and net. And when we back into what the number of procedures were in Q2, relative to the number of patients that were in or have been submitted for prior auth exiting Q1, it implied that you captured like 80% to 85% of those patients that exited Q1. Now we have the number for what the exit rate is in Q2. And if you take that same 85% number, it puts you at a revenue dollar in Q2 that's higher than what consensus models today.

So trying to get an understanding around maybe what the difference could be on the math, if it's because of net or gross, and whether or not it's fair to assume that, that capture rate of the exit prior auth submissions is a fair number to assume on a go-forward basis or just as you scale it, it should work its way down or up.

You want to take that?

Yes. So it's a great question. The reason why it's hard for you to model and us is because since we're early in the launch, and we're getting new VACs and new accounts approved each month. And when we have 55% more patients identified by physicians just over Q1, it's hard to model it because we're getting traction and momentum. And so I appreciate -- and you're right, when you talk about 80% to 85% capture because prior authorization sometimes takes -- maybe it takes 1 or 2 weeks for approval, but then you have to go through the whole scheduling process. And so we'll have patients that have approval in Q1, but don't get scheduled until Q3.

So there's always going to be some carry through. The 427 number is a really conservative number, right, because that doesn't include patients that we might be carrying over. But it's hard for you to model because we're just gaining our momentum. And these -- the additional 15 reps that Olivier just referenced, they're just now opening new accounts. And so we're seeing a broader influx of patients. And so it's hard to model that. And then to the physician's point, we have accounts coming on now that have never worked with us but are high volume and they're starting at a high volume. But I think you're thinking about it the right way. It's just hard to give you a direct number because of the adoption of the therapy. Was there a question from the...

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

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

But also, in building a little bit further on this, what we have learned is that there is a direct correlation also by having feet on the street and also accelerating the opening of new accounts. I think the 98% growth is demonstrating this. You also are aware that we recently also financed the company further. And I was always saying one of the key priorities in doing this is we would like to add more feet on the street. We would like to invest in U.S. commercialization. So with this, and maybe this is a primer, as we like to say, Scott is already hiring the next cohort of salespeople that are directly the result of our recent financing.

So we are accelerating this. We will be adding another 15 sales reps. The hiring is ongoing. We do think that they will also show us an impact already in the last 2 months, 2 or 3 months of this year and definitely setting us up in a stronger position also for entering 2027. So I think we covered the questions on this slide. So Scott, maybe also 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, healthcare providers and patients. And so on the surgery side, you heard it this morning from both of the physicians. Physicians want to offer options to their patients. And what I've -- in the early days, there's a lot of physicians that have come to us and they've walked towards us wanting Genio because they want to be the experts in their marketplace. This 88% of providers' commentary came from an external survey that was done where physician decision-makers said that they prefer options for their patients, and that's nearly 90%.

The DREAM study, and Jey is going to talk about our data, but the DREAM study allowed for patients with positional OSA. Those patients are very difficult to treat. Positional OSA patients were completely excluded from the STAR trial by Inspire and they were excluded from the OSPREY trial by LivaNova. So 70% of the patients in DREAM had a 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 chin. But then also think about the technology itself, it's smart app-based and the MRI conditions for Genio are minimal, and they're unrivaled by any technology, not only in hypoglossal nerve stimulation, but in most implantable products, our conditions are minimal. And then there's also this desire for patients for an implant for life, and that's because our activation chip is the brains to the operation.

The average age of patients in all of these clinical studies was mid-50s. So these are young patients. And so they're going to have to think what do I -- how do I want to plan the rest of my life? And when you -- we can take our activation chip and put it in its charger and have it update just like their 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 keep going beyond. And to restate something I said on the last slide, we have surgeon training every other week. We have sleep -- 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 5-minute break, and then we are back with clinical data and looking forward on the market dynamics.

Will that be okay? Can I just ask 5 minutes, not make it 10, but please limit it to 5, and I'll see you back shortly. Thank you.

[Break]

Okay. Thank you. And we will continue with Part 2. So Part 2, we will cover the clinical update. We have our Chief Science Officer, Jeyakumar Subbaroyan with us. We will talk about market dynamics with our Chief Strategy Officer, Ashlea Mittelstaedt. And then we will talk about our financial update with our CFO, John Landry.

So maybe, can I call all 3. Jey, Ashlea, John? So Jey, 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 who are coming up. So Okay. Switch. Yes. Okay. So from a clinical perspective, what can we -- is everything okay? Okay. From a clinical perspective, Jey, so what can we expect?

So thank you, Olivier, for the question, and good morning. It's a pleasure to meet everyone here. So in terms of the clinical update, the best thing we can give at this point is a quick update on the progress that we are making on the CCC indication. Just as you can see, Genio is not currently approved. It's -- we have a warning, not a contraindication. But just to give you a little bit of background why CCC has been challenging endeavor, we have 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, we are finishing the last of the patient follow-up for the ACCCESS IDE study, which focuses on hypoglossal nerve stimulation, this case, Genio therapy for OSA patients. That's next week. We'll have data readout before the International Surgical Sleep Society meeting in October. I'm pretty confident like based on like some of the early data that we have seen in BETTER SLEEP study, which was done in Australia about 5 years ago and also the early data that we are getting from the EU commercial uptake in the CCC patients that the data will be strong. We don't have any official data readout.

But if you can see these numbers, these are some clinically significant improvement in these patients. Of course, like if you look at the European commercial data, it is small numbers, but about 67% improvement in a small patient group. And our plan remains the same. We will write this up and submit the PMA supplement, as Olivier alluded to in the past, by Q4, and we are positive that this will result in some meaningful acceptance of the data from FDA.

Any questions on CCC and where we stand? David? No question on this one. No, because I think it's very important. We have been talking from the beginning when we looked at our bilateral stimulation effect, how we 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 Jey, I mean, already extremely strong words with you and the team. Sorry that you cannot disclose more, but I think everyone understands why on ACCCESS. But from a timing perspective, timelines is 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 U.S. to be very specific. Now next up, Jey, publications.

Yes. So the data is one thing, then the scientific dissemination of the data is equally important. What you see -- so there are 2 main themes if you look at this, right, like one of them is there is a heavy focus on generating evidence for actually 3 main themes on CCC, whether it's through clinical studies or real-world outcomes. That's one. And more real-world outcomes. You just see 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, the BETTER SLEEP study that 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 to 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. They're either -- like I said, it's in active review or in the process of submission. And to the right, we did talk about the ACCCESS study. We will write that up the same time we'll finish the CSR and the PMA supplement, and that will go to a high-quality journal. And more importantly, now we are actively collecting around 30 patients right now by my count, real-world data on CCC patients. The idea here is like these real-world patients would have been followed up a lot longer than what we have in ACCCESS. 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 then.

So ISSS in LA will be very important. We will have a lot of new numbers to disclose specifically on CCC patients. So also looking forward to seeing you there as well and updating you on this.

Jey, thank you.

Thanks, Olivier.

For this update. Stay with us. And we will move now to Ashlea. Maybe Ashlea, 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 Ashlea Mittelstaedt. I'm the Chief Strategy Officer for Nyxoah. I've been working in med device for over 20 years now, launched quite a few products in the ENT space and other indications as well. And I've been with Nyxoah since 2023.

Thank you. So tell us, Ashlea, what is happening in the market?

So I would say -- so I love this question. And even under the most conservative numbers, I would say we're still looking at a very large market, huge unmet need overall and underserved and underpenetrated. So all of those factors obviously play well. And with the clouds parting on the coding situation, I think there are some other drivers that we are really seeing play out well in the marketplace, especially for Genio. So when we look at what's happening right now, obviously, one of the bigger things within OSA is the expanding prevalence flow, but sure, in the United States, in particular, with the rising BMIs and then also the aging population, we're seeing quite a few women come into OSA.

This bodes really well for Genio because there's high appeal among women, female patients based on the design of the device and where it sits. What we're also seeing now with GLP-1s because of our timing in the U.S. market, we didn't really see the major disruption that some others 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 for us, obviously, we haven't been chasing BMI. We're looking for more interesting and complicated airway options. So that's -- I think, been an interesting one for us and seeing that definitely as a tailwind.

The other thing that we are looking forward to and have already been enjoying is HST reliability. And I say this from 2 perspectives. One is the sophistication of the devices, but also the coding clarity that's come alongside those as well. So when we look at what's happening with HST, this is something that works well with 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 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, Jey, you can also share your thoughts on this. So it says Genio focus on complex airway openings. So we have our cutoff BMI-32. Strategically, Nyxoah always has chosen not to build evidence in going with BMIs 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 are trying to power a system externally with the higher BMI, it becomes much more of an energy requirement. We can definitely reach if you really crank up the amplitude, we can. And we do have anecdotal evidence we can probably go up to a 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 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 Genio therapy, right? So that's something that we have seen that -- and again, all the conversations seem to lead to the fact that it will bring more patients within the treatment pool of Genio therapy that's currently indicated even without going to the BMI of 35.

You want to add something?

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. And 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, hypoglossal nerve stim.

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. And I think that's where we differentiate. Just wanted to point this out. But actually, I would let you continue.

Yes. So just really briefly, in addition to what we hear from physicians every day, we did some double-blinded research, and we found, again, surgeons value the option of Genio as well as the Genio design. We are seeing very strong adoption intent, and we've been very specific with our targeting, and we've been very successful with that targeting to date. We've seen a strong adoption ramp overall within the space, and we're also seeing evidence that our sleep strategy is absolutely on point.

I think one of the things that I'm also excited to see as we hear from physicians and especially patients is -- you talked before about the 20% to 25% 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, 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 Genio 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, 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'd say from the patient perspective, those are the 3 that are front and center. And when we say patients have declined for the battery design and other solutions, this is how they're coming forward.

From the physician perspective, you talked about complete concentric collapse. And obviously, there's a lot of interest there, obviously, expecting to hear more at ISSS. The other one we hear a lot about is MR-conditionality. And so obviously, any patient needing a lot of MRI-dependent care, we've got 3 torso MRI conditional, 3 tesla -- thank you -- in the torso. And lastly, obviously, position-dependent OSA. 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 Ashlea 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?

Yes. Maybe one. When you think about like, I don't know, 5 years from now, when you think about the CCC versus the non-CCC patient population, would you expect if there's 100 implants that you have, that there would be a higher percentage of those total implants that are coming from the CCC patient population, meaning that market expansion is more of the piece behind longer-term Genio adoption? Or 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 -- and Jey, feel free to fill in. But first of all, today, CCC is simply contraindicated for HGNS unilateral stimulation. So just by offering these patients also an HGNS solution, it's already a large win and will also have a positive impact in increasing the patient pool because today, 25% to 30% of those CCC patients cannot be treated. That's question. I maybe answer 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 hand, there is also the GLP-1 impact that is bringing down patients from a BMI 35 or higher into a segment, let's say, BMI around 30. So yes, that is the short answer. First of all, by treating something that cannot be treated today by unilateral stim. And yes, by also offering a treatment option with patients where you have a higher BMI. So that's our answer. Jey, if I'm forgetting something, please?

No, actually, I would defer to Mau and I want the surgeon's perspective, Mau, do you...

Well, I would say, number one, generally speaking, physicians and payers don't love drug-induced endoscopy. And so assuming things work out positively, CCC was no longer contraindicated, 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 his thoughts as well.

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

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

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 Nyxoah. 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 & Lybrand before the Price Waterhouse 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's a nice transition into the medical device space.

I've been here for over 20 years now, again, third medical device company. The first 2 medical device companies I joined were at a very similar stage to Nyxoah when I joined the company. We got about $5 million in revenue in both of those companies, and we were fortunate enough to grow both of them up over $100 million, still going strong today. So when I joined Nyxoah, I saw a lot of the hallmarks of those 2 companies in Nyxoah very specifically, great technology and outstanding patient outcomes. And I think the combination of those factors will allow us as well to get to $100 million in an accelerated fashion.

So one of the things -- turning now to the slides as we talk about the path to profitability. So one of the things that Olivier 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 breakeven point for us is EUR 150 million in revenue to get to breakeven. And what does that represent in terms of total market share? When you look at the total market share from an HGNS 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 6 months experience that we had in the U.S., we've seen about 15% in those accounts that we've seen to date already. And if you look at some of the commercial pilot experience that we had in Germany going back a couple of years, within 18 to 24 months, we were also at 20% to 25% market share within an 18- to 24-month period of time.

So when you look at that, that gives us confidence that we can achieve that revenue breakeven point within a relatively short period of time. Another key to this path to profitability is gross margin. We need to get our gross margin to scale at 80-plus percent, and we have a very defined pathway to get there with 2 key drivers. One is our Genio 2.2 device. That Genio 2.2 device will have a new activation chip as well as a new disposable patch. Both of these are redesigned for patient comfort first, and then also to reduce the cost of the device dramatically. We're going to take about 80 -- sorry, 90% of the total cost of that disposable out of the cost of the product overall, which will allow us to step function our gross margins from the low 60s to low 70s when we roll that out in the first half of 2027.

Additionally, another key driver is around our volume discounting. So we have a contract manufacturing agreement with a manufacturing firm here in the U.S., and we have predefined volume-based price points in that contract. So as we drive volume through the contract manufacturing firm, we'll see another step-up in gross margin to get into the low 80% range. So those are 2 very key drivers that will get us there. They're very defined. They're very tangible, and we have pathways to go out and execute upon both of those within this timeframe.

Another item on the bottom left hand of the screen is our annualized cash operating expenses. So we want to maintain tight financial OpEx discipline throughout the organization. And what we've done a couple of things. One is we've taken a look at our operational expenses and then redeployed operating expenses from parts of the business that we needed to grow and scale in order to get to commercial launch. We know 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 we have -- that's laid out in front of us and very happy to have that behind us, and that gives us the cash to get to profitability and to get to cash flow positive.

So that's very important because that allows us to go out and focus on the business, focus on executing our strategy and building a very strong business here that's profitable and can continue to scale. So that's our path to profitability.

The next slide that you see up here is just a graphical depiction of what that looks like, and it compares and contrast 2 things. One, it compares and contrasts our 2026 guidance as laid out from a revenue, gross margin, cash OpEx perspective and the operating result. And then what you see in the pale colored bar graph side of the chart. And then you have the teal colors, which represent what this path to profitability looks like at EUR 150 million of revenue with an 80% gross margin and OpEx of EUR 105 million You can see that we go from a negative operating result to a positive operating result at that level.

And one of the keys there is, again, gross margin and the OpEx and managing our OpEx to be able to drive continued growth and knock that operating result in the opposite direction. A key element that you'll start to see in our financial statements as we publish on a quarterly basis is our cash burn will start to come down. So for the first quarter of 2026, we had cash burn of approximately EUR 22 million. With the cash balance that we presented here in the release, if you adjust for the cash that we raised, our cash burn was about EUR 19 million. And I would expect to see that continue to decrease quarter after quarter by roughly EUR 2 million to EUR 3 million per quarter until we get to breakeven and then positive thereafter.

So this is really something near and dear 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 discussion on this. So I want to ask questions on this part because we can explain this. But on the other hand, you also need to believe what we are explaining and to feel trust behind this plan. So I think it's a good moment to have this conversation since we are here together. So any questions on this path to profitability?

Yes. I guess I'll ask one.

Yes, please.

I feel like when we look at other similar stage medical device companies in the past several years, that profitability or breakeven level had said 3, 4 -- $500 million in sales, right? And EUR 150 million, of course, is a lot sooner than at least what we have seen in the past. So I guess what gives you the confidence that the level of spend that you expect at the year in which you get to EUR 150 million relative to that number will still be able to support growth on a go-forward basis and EUR 150 million 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% of the total HGNS 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 DTC channel and how to make every dollar count and be optimal and efficient in that regard, that will allow us to drive the patients in the top end of the funnel, allow us to generate that growth and do so in a way that's economically efficient to allow us to get to that breakeven point faster than our competitor did. So that's how we're thinking about that.

And I think maybe in addition to this as well, sometimes it's nice to be second to the market. And what I'm trying to do this is that you can accelerate, you can go much faster take, for example, the reimbursement aspect that we covered. We just launched a technology. We have reimbursement in place. We get a good payment. It took Inspire 5 years to get to a point where they had coverage from a decent amount of payers in the U.S. to start generating revenue. So I do think if you follow the calculation that the calculation as such makes perfect sense. In the modeling, it's more about the timeframe, 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 -- the revenue expectations for HGNS are between [ $850 million ] to [ $875 million ].

And going forward, next year, I do think we will be touching EUR 1 billion. And if you are touching EUR 1 billion and you want to have EUR 150 million to get breakeven, it corresponds with the market share percentage, where we today or feeling confident listening to Scott, seeing how we are ramping up and seeing also the excitement with physicians and with patients that we are capturing. But again, how do you say this? The proof is in the eating of the pudding or in the pudding, it's something with the 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.

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

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

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

Yes. And that's exactly what we are seeing today. The patients we are capturing, the ones that Dr. Huang and Dr. Jain were referring to, those are patients that normally would get the Inspire implant. Today, they are getting the Genio implant. So it's not -- our success will not be defined from the new incremental patients and how strong we are there, it will be defined from the total patient population that gets an HGNS implant. So that's why I was saying no. A second question...

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

Yes. So I will take this one. I know that Scott is also having an opinion on that one. It will be a combination. 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's clear it's going to be from the initial hires because there's a 6- to 12-month start-up time. That's not going to change. We still have to get into new VACs. We still have to train new surgeons. And so the growth is going to accelerate from the accounts that we've already penetrated because we've built a referral pathway in those accounts. We've built comfort with the surgeons in those accounts, and they're seeing great results with their patients. And so the referral rates are accelerating for Genio from the referral in existing accounts. And so our initial cohort of hires have really, what I call, walked through the desert of getting us to this point of proving the concept to U.S. physicians and they're adopting it at a high rate.

We still need to scale soon because we have to get those reps deployed so they can start the VAC process and start the surgeon training in the new accounts. But it's a great question. The bulk of our growth and acceleration is going to come from the people who've 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 is a moving target. And so -- but what I'll be focused on moving forward is exactly what I presented today.

Okay. So -- then John?

Okay.

We have a question here.

Sorry, John.

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

Yes, it's a good question. I think from our perspective, we expect to gain market share and still be at the 15% level in these accounts and continue to growing. Another factor that as we look back at the Germany experience, the German experience before we entered into the market when it was just a monopoly, the business was growing roughly low double digits in terms of growth percentage on an annual basis. Then when we entered the market, the growth rate in the overall HGNS market moved to like the 25%, 30% range.

So with more players in the market, we would expect to see growth increase as well. And we expect, based upon the results that we're seeing and the patient outcomes, we would expect to see that market share for us continue to be there and continue to grow over time.

Yes. And then maybe in addition to this as well, so we also showed that the current HGNS 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 HGNS. 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 HGNS and on LivaNova, so that since this is touched as well, from a technology perspective, this is another pacemaker solution, where Genio is totally differentiated, and that's also how we position.

So we do think that within the pacemaker solution, there will be a competition between both companies where we see Genio as more of the unique totally differentiated approach. But to answer your question, we want to capture 15% market share of HGNS as a total.

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

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

Yes.

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

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

I have a practical applications of this that we discussed today as well. If you look at -- you asked about traditional market development or market growth drivers, we haven't presented the ACCCESS 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. Jain offered earlier today, these options -- and it's not just Genio, there's options across the sleep space are naturally bringing more patients into sleep physicians already. And so I would argue that with the technology that we already have and the clinical data that we already have, we have the potential to grow the market higher and faster than our competitor and the fact that there's an explosion in the sleep space of interest in options that patients are already coming in.

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 rule perspective, we are giving a guidance for '26, reaching EUR 36 million to EUR 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 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 underpenetrated, there are so many patients, I mean, only this will already give us a lot of tailwind in growing before we are 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 is a huge expansion of all 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 CCC indication. So I think -- 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 quarter 2 and the 25% to 30% sequential growth you had guided for?

Yes. Yes, we can. And 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, I'm looking at Scott, on June 30. And unfortunately, there are not 31 days in June. It was 30 days. And as a small company, there is a person who need 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's the honest answer. John?

Okay. So we just touched upon the preliminary results for the second quarter. So you can see our revenue for the second quarter at EUR 7.7 million, EUR 5.2 million of which came from the U.S. and the 22% mentioned quarter-over-quarter growth. We had EUR 2.5 million in our international business. Our international business continues to grow nicely as does our U.S. revenue on a sequential quarter-over-quarter basis. So when we look at this year-over-year for the first half of 2026, we booked about EUR 14.1 million of revenue. That compares to about EUR 2.4 million in the first half of 2025. So we almost have fivefold increase in terms of what we've been able to do in terms of growing the business on a year-over-year basis.

So that's an outstanding outcome and testament to both our U.S. international sales representative driving growth on a worldwide basis. So as we look at full year 2026, we are continuing to reiterate our guidance for the full year of EUR 36 million to EUR 40 million for the full year. And with the delta, the 22% to 25%, as Olivier explained, we have orders in hand, product out the door. So we're confident in that number. Now while as some people have pointed out, that provides us with a little more -- we need to deliver more growth in the back half of the year because of the second quarter result. We're very confident that we have the orders, we have the pipeline, we have the backlog to be able to do that.

And very specifically, when I speak of backlog, I'm thinking about those number of patients that are in the pre-authorization process, the 427 patients that are in preauthorization, that grew 77% in the second quarter versus the first quarter. So from my perspective, I feel very comfortable that we have 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 it back over to you, Olivier.

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

Microphone. Does it work?

Yes.

I'm Robert Taub, indeed the Founder and the Chairman of this company. And I can say for sure that I'm the most senior person in this room. I'm a serial entrepreneur. I'm Belgian. I've lived in New York for a while also. And I have, yes, 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 we have 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 repeat all of that. But yes, the whole thing is about value creation. And right now, our focus is on the U.S. commercial execution and that we want to be the leader in HGNS in the United States, actually also in Europe.

Clearly, there is a huge challenge for the company in general to recreate the trust that we have lost with The Street. That's clear. And this is not going to be done easily, but we will execute quarter-by-quarter our 25% growth or more. And it will take many quarters in order to recreate this trust, but we will be there. And at the same time, we will continue to look very carefully at our OpEx in order to manage, if you want the cash that we have and that we will never have to raise money again because this was a painful, obviously, very painful exercise last time. And however, we -- by managing this cash, we also have to remain innovative because focus is, of course, Scott, to deliver his quarters -- one quarter after the other. But on the other hand, we also have to maintain our leadership in innovation.

Now I have to say that there's a lot of technology that is available in the company, which has not been exploited yet and even in the activation chip. And so because all of this can be developed and is even available in the activation chip, but not used at this stage. And so these are some of the things that we will be able to develop without too much money in the wearables and -- but we're also looking at, of course, other technologies, but we will be very, very tight on the cash. So focus for the next 18 months is the launch. And to quote a bank that has shown us some statistics, we have -- Nyxoah is in a perfect situation. I mean the total addressable market remains huge, as you know, only in the United States, you have 500,000 new patients eligible for HGNS every year. So the total addressable market is really continues to grow.

We have gross margin, as John has explained at the moment, we do not have yet this 80%, but we will get there, and we know how to get to 80%, and the growth in general will be 25% quarter-by-quarter. And if we compare this to the 150-odd med tech listed companies, there's only about a handful of them, maybe a little more than a handful that will meet all of these 3 criteria: gross margin above 80%, a total addressable market. I'm talking about med tech company, but also some hybrid companies that are -- and this is -- and of course, the growth, the annual growth, which we will be exceeding at least in the first 3 to 4 years.

So if you want -- that is the way I see value creation. Now I will not avoid, of course, speaking about the CEO transition because that has been, of course, a question that has been asked, et cetera, et cetera. Yes. I mean the growth of the company and the success of this company will be in the United States. And we made a decision together with Olivier that we will have a U.S. CEO and a U.S.-based CEO, but also an American CEO. And we started the search only, what is it, 5 weeks ago or 4 weeks ago. So it's going to take still some time, but everything is set up that by, let's say, latest the end of the year, we will have a new CEO, possibly earlier. We're using, of course, a headhunter.

And that's in a nutshell, what I wanted to tell you. And of course, I'm open to questions, but I invested quite a bit in the company from the very beginning, 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 we will -- I will now do my closing slide. And then we will open it up the last time for the entire management also for further questions if there should be any. No, 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 are talking about structural tailwinds for the obstructive sleep apnea business in general. I mean it's a quick recapitulation. The addressable market underpenetrated. Robert was just mentioning 500,000 eligible to treat patients in the U.S. alone. I mean, today, more or less 40,000 are getting treatment.

If we look at the GLP-1, a lot of words have been discussed on GLP-1s. I think by now you understand our view. We see this as a catalyst, and we also know that it will drive more patients, it will increase awareness. Reimbursement, Jo and Carla, thank you for providing further clarity. I hope that the dust has been as settled as they say in the U.S. on this reimbursement. There is reimbursement, there is a coding. Yes, there is an evolution, but there is no reason to be thinking or considering that we would be out of reimbursement. On the contrary, with the latest CMS proposal, I think it's even more beneficial.

Optionality also to Ashlea'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 U.S. that this is all the right way and that we are really well embraced by physicians as we are by patients.

Now in going forward, our vision, so one OSA ecosystem, I'd 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 6 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 patients. You can have the best technology ever. If a patient is not using the technology, it's useless. As simple as this.

And we do believe 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 clear 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 life feedback on their sleep quality. And I'm wearing a WHOOP. I think some people are wearing an Oura 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 MRI compatibility that designed for forward compatibility. So also there, we are unique. Nobody else can offer the same thing. Sometimes it's nice to say this, but that's exactly what it is. And then in going forward, also what can you expect from Genio. So as we are growing, we are capturing data. I mean, today, there is something called AI, ChatGPT, Claude, whatever are the names. But these things, if they are well used, they will help us accelerating, getting even better in providing feedback in developing cost economic effectiveness data. So also this, we are integrating.

And then there was a question, I think it must have been from David since he's asking 90% of the questions. But no, David, sorry for the joke. But also, what do you expect in 5 years from now? What we expect in 5 years is that when you are suffering from OSA, you don't feel like a patient. You go to sleep, the system will detect that you are sleeping and activate itself. The system will automatically adjust stimulation just in what you need to have a good night rest with your airway remaining open. It will be a self-learning system. And when you wake up in the morning, you get all the feedback that you are waiting for on quality, on oxygen desaturation, on hypoxic burden. And we will also measure and make sure that all these data are incorporated and show the payers how much profit, if I can use this, or how much less they will be spending by an optimal management of an obstructive sleep apnea patient.

That's what we stand for. Those are the last words of this investor meeting. Thank you again for being here. Looking forward to continue interacting more in going forward and looking forward to show you not only 25% because next quarter, I think we will be showing 35% to 45%. So I do think we will have to accelerate even further, but also there, we think we're in a good position.

Thank you. And let me invite you also for a light lunch because you know there is a relation with BMI and OSA. So a light lunch.

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

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

I'm on the medtech team here at Bank of America. Really happy to introduce our next presenter, Nyxoah. We have CEO, Olivier Taelman, to present.

Good afternoon, everyone. First of all, thank you, and thank you, Bank of America, for having us and to be able to explain a little bit and talk a little bit more about the Nyxoah story. When we talk about Nyxoah, we are talking about obstructive sleep apnea and the treatment of obstructive sleep apnea by offering a neuromodulation solution.

Before I dig in a little bit further into our technology, I would like to talk a little bit more about the market space. I think everyone is familiar with someone who is struggling from sleep apnea wearing a CPAP mask. It is a huge market in the U.S. It's a huge market globally. But when we focus on the U.S., we are talking about a $10 billion market opportunity or roughly 500,000 patients that are annually eligible for treatment because they suffer from moderate to severe obstructive sleep apnea.

What we offer as Nyxoah? We offer a totally differentiated and unique neuromodulation solution. And I will be walking you through this in a couple of slides and showing also the technology. We have compelling clinical evidence that resulted in FDA approval. We obtained FDA approval last year in August, and we are currently actively launching. Yesterday, in fact, I did the earnings call for our Q1 results now 6 months post FDA approval. In the meantime, we treated over 1,200 patients in Europe to be very precise and the longest implanted patient with our Genio technology is already more than 7 years benefiting from the technology and as I was mentioning, I think the most exciting point that we are currently going through in the stage of company is that we fully transitioned from a clinical stage company into a commercial stage company in the U.S., but also in other countries around the globe.

Now before I continue and go a little bit more in depth on the technology as such. I make it like a case of honor to start by saying why are people in need for treatment when you suffer from obstructive sleep apnea. And to make a long story short, every time when you go to bed and you start sleeping, you will have an airway obstruction that can be 15, 20, 30, 40 times every hour, and that is causing a lack of oxygen to your vital organs. So what you see is when you are not treated for your obstructive sleep apnea, that the risk for comorbidity significantly increases, the risk of cardiovascular incidents go up by 5, the risk of heart failure almost triples and the risk of stroke doubles.

There is also a clear link with a high prevalency in other key chronic diseases. I'd like to point out diabetes type 2 because we're also seeing that this is a fast-growing business in the current society globally. And there, we already know that 72% of all type 2 diabetes patients are also suffering from obstructive sleep apnea. When you look at obstructive sleep apnea, there is clearly a graduation linked to the severity. If you have 15 or more obstructions every hour, you are a moderate obstructive sleep apnea patient and you are in need for medical treatment. If you have more than 30 obstructions every hour, you become a severe patient and you definitely are in need for treatment. Sometimes, and it's a little anecdote, people are always talking. Will this also help against the snoring? The answer is yes, because every obstructive sleep apnea is snoring, but it's not because you snore occasionally that you suffer from obstructive sleep apnea.

The treatment options, as I mentioned before, the golden standard still is the CPAP mask. Besides the CPAP mask, there are also mandibular advancement devices, mainly prescribed by a dentist. What we are seeing is that they are more focusing on soft or less than moderate obstructive sleep apnea and also from a clinical evidence perspective, they are not so backed up. It's also highly costly. It's all out-of-pocket pay and for those who can benefit from them, the better. But it's not the kind of treatment option that you use if you're suffering from moderate to severe OSA.

There was traditional surgery. It's highly painful. We're also seeing that success rate is relatively low. And we see also that it's more something that is done with the old generation of ENT surgeons and that with the younger generation is no longer part of their treatment palette.

Now when we dig in a little bit deeper to Genio and our solution, I was talking about a totally differentiated solution. So we have 2 components. There is 1 implantable aspect, the implantable stimulator as you can see on the bottom right, it's a passive device. There is no battery implanted. And it has 2 pedal electrodes. Why 2? Because if you look at the hypoglossal nerve, it also splits in 2 branches. And we are the only company with a technology that is stimulating both branches. Now why is this important? Two reasons. One, it will give you a strong therapeutic effect. And second, it also will consume less energy. And why is this so important? Because when a patient is sleeping, the last thing you want to do is wake the patient up by stimulating too strong or too intense. When you have a bilateral stimulation, you get the same strong effect with less stimulation needs from electric pulses.

Because it's a passive device, it also automatically generates a full body MRI compatibility. As I touched earlier, a lot of the people are having other comorbidity factors. So it's also important that you know when you're implanted, you never need to worry when there is an MRI scan that is needed.

Now going to the second part, it's the external or the smart wearable component. As you can see, the gentleman in the drawing is wearing this under the chin. So it's a very small wearable component that is containing 2 things: battery and through induction, it will activate the passive implant and it also contains software. Now, we call it smart because it understands what kind of stimulation it needs to send through to have an effect on the airway opening of the patient. And also by having an external battery, there is no need for repetitive surgery replacing a pacemaker that could be depleted. There is also no need for repetitive surgery when there is a software upgrade, we simply push it through like people are used to with their smartphone.

In the morning, when you wake up, you just open the app on your phone and you get a lot of information on your sleep quality. And we also learned that this is something that is highly valued by patients because it gives them not only more comfort, but it also give them a kind of involvement and a kind of power of their technology and seeing that their sleep quality is increasing. As a medtech device with an implantable component, it's clear, everything starts with robust clinical evidence. I will not go too much in depth on this one, but I would like to highlight 2 aspects. One, there is the effectiveness of your technology. So we reach our primary and secondary endpoints, expressed in an index, the hypopnea index and oxygen desaturation index. So we met all our primary endpoints. And then the next aspect important for physicians and patients is, is it a safe technology when you implant and also there with 8.7% severe adverse event rate, it brings us and makes us one of the lowest or one of the technologies with the highest safety profile that you can find in neuromodulation.

Important, once you are implanted is that we see that 82% of all patients implanted with Genio, we are able to reduce their AHI below 15. As I mentioned before, 15 is the cutoff point for the need for surgical treatment. If you are below 15, your risk of cardiovascular stroke et cetera, is identical to people who are not suffering from OSA. So 82% of all our patients implanted or having an AHI that is being reduced below 15 and bringing them back to normal standards.

Commercialization. And I was mentioning FDA approval, the U.S. is the largest market for obstructive sleep apnea. So it has been our goal from the beginning to enter this market and to try to be successful. If you look at our commercialization strategy, we are using a so-called smart follower strategy. On one hand, we focus on where the patients are, and they are in high-volume hypoglossal nerve stimulation center with ENT surgeons that are very familiar also with our competitive or with competitive technology. That's where we go with our sales force, position our technology as a totally differentiated technology and then also go after patients that are showing up and being referred by sleep medicine.

It brings me to the second part of the strategy. We will immediately from the beginning, also try to partner a sleep doctor with the ENT surgeon colleague so that when it comes to patient phenotyping identification, the sleep physicians, they have a crucial role because they are also the CPAP prescribers. And then once the surgery is done, we also make sure that they stay involved also in managing, in fact, the implanted patient with their technology. So that's how we launch in the U.S. We learned that in the U.S., you have roughly 400 implant sites that are generating 70% of the total volume in hypoglossal nerve stim. So it's a very concentrated. The 400 accounts, they are generating, if I would put some dollar amounts behind more or less $600 million to $700 million on annual basis.

I have a team, commercial team in the U.S. of 60 dedicated people. 40 of them are the sales reps, then we have roughly 10, 15 field engineers. There is some marketing, market access people and there are also some clinical and training education people. Reimbursement-wise, has been a hot topic lately in hypoglossal nerve space. I think finally, there is clarity. And I'm also extremely pleased that we were not directly impacted with all the changes and the unclarity that was taking place.

Let us look at some results and some numbers. So 6 months post launch, we were able to train in the U.S. 207 surgeons with our Genio system coming out of 125 high-volume sites. We had 62 surgeons trained in Q1, just to give you an indication, how fast it's growing and how fast the uptake is. We have currently 91 active sites, all of the 125 high volume sites we targeted. 34 new accounts were activated in Q1. What do we mean with an active account? There are 2 parameters, the surgeon needs to be trained and also the value analysis committees need to give them their approval, there need to be a price in place so that we can do business. Once all this is in place, we can start recruiting patients. And exiting the first quarter, next to the implants we did, we have 241 patients lined up with a full prior authorization file submitted to a commercial payer that will be implanted in the quarter going forward.

We also invested in some more feet on the street. We hired 15 more sales reps so that in total, we have now 40 people that can cover all of the 400 high-volume accounts. From a finance perspective, in Q1, we generated EUR 6.4 million. Apologies, I have to talk in euros, but we are still at headquartered in Belgium, and that's why we use the euro amount still today when we report our finance. You can see it was a nice growth, 13% global growth versus Q4 knowing that Q4 always is followed by Q1, where you see a lot of seasonality, 13% growth was a very strong result. But I think what was even more stronger and everyone is looking for is, how is the U.S. growing. And there, we generated EUR 4.3 million of showing a 25% growth over Q4. So if you combine everything, we can speak about a successful first 6 months. And we know that there were a lot of more patients that are lined up to be implanted. So the next quarters will be -- continue to be strong. We gave guidance up to 30% growth versus Q1 in the second quarter.

Our cash and our balance sheet, we are still EUR 26 million on the balance sheet. We will draw down a loan from the European Investment Bank of another EUR 13.8 million. If you look at the guidance, I was already referring to this, we are giving 25% to 30% guidance for the second quarter in the U.S. over the first quarter. If you look at the annual revenue target first year of launch, we are forecasting to be between EUR 36 million to EUR 40 million. And I do think that is a strong uptake in the first year of launch in the medtech company, gross margin 60% to 62%. They will further increase to 80% when volume also will start increasing and our total operating expenses will be between EUR 97 million to EUR 99 million.

Briefly, international markets, and I will not bother you too long with this, but I just would like to share that we did our first commercial efforts in Germany. And Germany was not incidentally picked. We went there because competition was there as well, and we did a commercial proof of concept. What have we learned? We learned 3 things: one, that when we entered first year, we were able to take 20% market share. Second thing we learned in this that when we went into the second year of launch with our referral strategy, the market share increased to 25%. And the last thing we learned in this in 3 years, we were able to go from launch all the way to profitability in 3 years already.

I think my time is also up. So this is the last slide. What can you expect from us going forward? We will selectively invest in innovative leadership. So we're talking about smart wearables and intuitive apps. We are working on a cloud-based solution and telemedicine and of course, since we are increasing volume and we are capturing all data, we also will incorporate AI tools to make sure we can learn and we can learn fast.

With this, I would like to thank you. I will not go too much over time. And once again, I hope it was interesting listening to this. And if you have someone who is suffering from the obstructive sleep apnea, you know where to find us. Thank you.

Good day, and thank you for standing by. Welcome to the Nyxoah First Quarter 2026 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I'd now like to turn the conference over to your speaker today, Pearson Dennis. Please go ahead.

Thank you. Good afternoon, everyone, and I welcome you to our first quarter 2026 earnings call. Participating from the company today will be Olivier Taelman, Chief Executive Officer; and John Landry, Chief Financial Officer.

During the call, we will discuss our operating activities and review our first quarter 2026 financial results released after U.S. market closing today, after which we will host a question-and-answer session. The press release can be found on the Investor Relations section of our website. This call is being recorded and will be archived in the Events section on the Investor Relations tab of our website.

Before we begin, I'd like to remind you that any statements that relate to expectations or predictions of future events, market trends, results or performance are forward-looking statements. All forward-looking statements are based upon current estimates and various assumptions. These forward-looking statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements.

All forward-looking statements are based upon current available information, and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these forward-looking statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 20-F, which was filed with the Securities and Exchange Commission on March 26, 2026.

With that, I will now turn the call over to Olivier.

Thank you, Pearson. Good day, everyone, and thank you for joining us for our first quarter 2026 earnings call. Let me start with the Q1 2026 overview. The first quarter of '26 marked our second full quarter of U.S. commercialization, and we are encouraged by the strong execution of our U.S. launch. Specifically, we delivered on our commitment to drive 25% sequential U.S. revenue growth in the first quarter of '26 versus the fourth quarter of '25. In the U.S., we are seeing consistent momentum across our key commercial indicators, including surgeon training, account activation, patient prior authorization submissions and procedure volumes. Internationally, our revenue in the first quarter of '26 was consistent with the fourth quarter of '25, which represents strong performance as we were able to grow the business and avoid the typical sequential quarter decline from the fourth quarter to the first quarter. On a worldwide basis, I'm pleased to report that we grew our revenue by sequentially by 13% sequentially over the fourth quarter of 2025.

Let's now dig in, in the U.S. commercial update. The U.S. launch remains the primary driver of our worldwide revenue growth and our key priority. During the quarter, we continued to execute on our focused commercial launch strategy and further expanded our U.S. commercial field presence with an extra 15 sales reps who are now fully operational, enabling us to cover up to 200 high-volume hypoglossal nerve stimulation accounts ending Q2. I'm pleased to report on our U.S. launch key performance indicators as of March 31, 2026. We have trained 62 new surgeons in Q1, bringing the total to 207 surgeons trained on the Genio system.

We have activated 34 new accounts in Q1, bringing the total of 91 active accounts out of our 125 targeted accounts. Active accounts are defined as surgeons trained and VAC committee approved. We have 241 new patients submitted under prior-authorization and still pending at the end of Q1.

We have trained 50 new sales reps, bringing the total to 40 fully operational sales reps as we enter Q2. 6 months post launch in the accounts where we are already active, we estimate our market share to be between 12% to 14% on average. With the addition of 50 new sales representatives in the U.S. who are fully trained in Q1, we will be able to cover 200 out of the 400 high-volume AS accounts beginning in Q2. We also recently conducted a market research study of 100 U.S. hypoglossal nerve stimulation implanters. We learned that 88% of ENTs believe it is important to have multiple hypoglossal nerve stimulation options for their patients.

All Genio trained surgeons plan to adopt Genio in their practice. The top-sided reasons for adopting Genio were bilateral stimulation, no implanted battery and offering an alternative option. Sleep medicine is the single biggest source of their patient referrals and 84% of surgeons collaborate with sleep medicine colleagues to manage AGNS patients. The result of this market research confirms that our focused launch strategy on high-volume hypoglossal nerve stimulation implant centers in combination with building sleep physician partnerships will drive further Genio adoption.

Let me now cover one of the hot topics of Q1, the hypoglossal nerve stimulation reimbursement landscape. In order to provide you with a structured update, I would like to split it up between commercial payers, Medicare and the WISeR program. Starting with commercial payers. They represent approximately 90% of our cases in Q1. Coverage is broad and stable. Genio claims continue to be processed under the CPT code 64568 or even under the CPT code 64582, depending on payer policy and individual case review.

For example, UnitedHealthcare recently added CPT 64568 back to their existing AGNS policy in parallel to CPT 64582. So both codes are available for AGS. UnitedHealthcare represents one of several commercial payers, which have both CPT 64568 and the 64582 listed as available codes for AGNS procedures, including Genio.

Through the end of the first quarter, we maintained a approval 100% approval rate on reviewed prior authorization submissions. Now moving into the Medicare side, which only represents approximately 10% of our cases in Q1. The year started with coding uncertainty negatively impacting AGNS implants. On February 26, however, CMS provided clarity by issuing AGNS-specific C-codes for facilities.

Claims for Genio implantations are submitted under the C-code C8011. This code represents a facility fee mapped to the APC Level 5 at $31,526 in the hospital outpatient setting and $27,563 in the ASC setting. This is equivalent to the existing CPT code 64582 in hospital settings and slightly higher than the CPT code 64582 in the ASC setting. This results also in price parity at facility level for Genio and competition. Next, from a physician fee perspective, claims continue being submitted under CPT64582 at $722. When it comes to the use of modifiers, let me reiterate that it is a physician decision based on the specific surgeon work performed and that Nyxoah is not advising to use of a modifier.

As to the newly established WISeR program being an AI-supported prioritization tool rolled out by CMS in six different states since January 1, 2026, we have achieved a 100% approval rate of our submitted Medicare patients. The fact that reimbursement didn't hinder our Q1 launch momentum is the result of the expertise of our market access team, the collaborations with experts in that field, our participation in the FDA early payer feedback program and the proactive education of all our customers. Because of these factors, we expect continuity for '26 and into 2027.

As part of the ongoing CPT editorial panel discussion regarding the future of AGNS coding, the panel has indicated that there is no intention to lease any AGNS technology or fund without appropriate coding. For 2028, we understand that there are currently 2 parts to support continued coding being dedicated CPT codes for the different AGNS technologies or creating a comprehensive AGNS coding set. Following the model laid out in the CMS C codes, we learned that competition has chosen to seek its own dedicated code, which we are prepared for as well. Alternatively, specialty societies may seek to engage in a broader exercise to provide further clarity regarding coding in the AGNS space, creating a comprehensive AGNS code set. We will take our lead from the specialty societies, including AAO, [ HNS ] since their actions are driven by the physicians performing these procedures.

Let me now move to an international update. Internationally, we are seeing continued growth, and we managed to overcome seasonality versus Q4 '25. This was driven by a strong performance in Germany, where we are going deeper in existing accounts, continued therapy adoption in the Middle East and successful entries in the U.K. and the Netherlands. However, we maintained a disciplined financial approach focused on reaching breakeven as demonstrated in Germany, 3 years post launch.

With that, I will now turn the call over to John for a detailed overview of our financial results.

Thank you, Olivier. For the first quarter of 2026, gross revenue was EUR 6.7 million before EUR 300,000 in deferrals due to the delivery of disposable patches, which are delivered over time, resulting in net revenue of approximately EUR 6.4 million. This represents 13% sequential worldwide growth compared to the fourth quarter of 2025. U.S. net revenue was EUR 4.3 million, representing approximately 25% sequential growth compared to EUR 3.4 million in the fourth quarter of 2025.

Our U.S. revenue growth reflects continued expansion in account activation, increasing procedure volumes and growing surgeon adoption. Gross margin in the first quarter of 2026 was 57% as compared to 62% in the first quarter of 2025. The decrease in gross margin was due to production yield issues in the quarter, which have been addressed.

Operating expenses were EUR 24.2 million in the first quarter of 2026 as compared to EUR 21.4 million in the first quarter of 2025. The increase in operating expenses was driven by increased investment in the U.S. commercial organization, including sales, marketing and market access functions. Non-GAAP cash operating expenses were EUR 21.7 million in the first quarter of 2026 as compared to EUR 19.5 million in the first quarter of 2025. The increase in non-GAAP cash operating expenses also reflects increased investment in the U.S. commercial organization. As of March 31, 2026, cash and cash equivalents and financial assets totaled EUR 25.9 million. In the second quarter of 2026, we expect to draw approximately EUR 13.8 million from the second tranche of our European Investment Bank loan.

Now let's turn to guidance. We expect U.S. net revenue for the second quarter of 2026 to grow approximately 25% to 30% sequentially over the first quarter of 2026. For the full year 2026, we expect worldwide net revenue in the range of EUR 36 million to EUR 40 million. We expect gross margin in the range of 60% to 62%. We expect total operating expenses in the range of EUR 97 million to EUR 99 million. We expect total non-GAAP cash operating expenses in the range of EUR 88 million to EUR 90 million.

Please note that our total non-GAAP cash operating expenses for full year 2026 reflect a 5% to 8% sequential increase over non-GAAP cash operating expenses of EUR 83.5 million for fiscal year 2025. Strategically, we will focus our investments in supporting our U.S. commercial activities, including sales, marketing and market access as well as key R&D initiatives, including our Genio 2.2 upgrade, which includes a new suite wearable with upgraded software and a low-cost disposable patch to be launched in early 2027. We decreased our total non-GAAP cash operating expenses by EUR 300,000 to EUR 21.7 million from the fourth quarter of 2025 to the first quarter of 2026.

We also decreased our non-GAAP cash R&D expenses by EUR 2.9 million sequentially from the fourth quarter of 2025 and reallocated this capital into our U.S. commercialization efforts. We are applying the same principle for the G&A portion of our SG&A operating expenses, which if we were to break them out separately, you'd be able to see the transition from G&A-related expenses to U.S. commercial activities. Long term, we expect to drive gross margins over 80%, and we will continue to manage our non-GAAP cash operating expenses tightly while investing in growth and gross margin improvement drivers.

We believe this disciplined approach will allow us to achieve revenue breakeven below EUR 150 million in revenue. With that, I'd now like to turn the call back over to Olivier.

Thank you, John. As we enter Q2, our priorities remain clear: further execute on the current launch momentum in the U.S. capture greater market share in our targeted high-volume accounts, maintain a disciplined financial approach to OpEx and cash management.

Before closing, I would like to thank the Nyxoah employees for their contribution in making Q1 a successful quarter.

With that, I would like to open the line for question and answers.

[Operator Instructions] Our first question today will be coming from the line of Adam Meter of Piper Sandler.

Congrats on the solid progress. Two from me. The first one is on the guidance front. I wanted to ask about the full year '26 revenue guidance that you provided, and that is above where the Street is currently sitting. If you look at kind of where you've guided Q2 U.S. revs, it does imply a bit of a step-up in the back half of the year. I know Q4 is typically a seasonally stronger quarter, but maybe just talk about the confidence in achieving the full year outlook, especially in light of the ongoing reimbursement situation and talk about some of the kind of key drivers of the ramp. And any help on quarterly phasing would be appreciated.

So let me start by answering the question. So first of all, as we already communicated, we continued adding salespeople into our -- into the field. So we added 50 new sales reps, bringing the total to 40 salespeople, which enable us to cover 200 out of the 400 high-volume accounts. As you also know, surgeons, when they start implanting, they go through their surgical learning curve. This takes roughly 2 to 4 implants. And then you also see that they are scaling up. What we have learned in Q4 and in Q1 is that we got a lot of positive feedback from surgeons after their first cases.

And on top, after seeing the first patient activations, what was confirming the strong away openings that they saw during the surgery gave them even more confidence in start treating immediately more new patients. So that's one aspect. So you have more feet on the street and you also have more experienced surgeons. In parallel, the VAC approvals, you know that we cannot control the time lines. Sometimes it varies from 1 week to 2 weeks all the way up to a couple of months. Also here, we are seeing great progress made, and we have now 91 active accounts already out of the 125 targeted sites with our initial 25 sales reps.

So also this is driving an acceleration in adoption. And of course, in the end, there is also the patients and also the patient referral part coming from sleep physicians. I'm extremely pleased also that I was able to announce that we have 241 real patients with a submitted prior authorization file to a commercial payer while exiting entering Q2 exiting Q1. So if you add those leading indicators up, that is giving us confidence of showing continued strong double-digit growth, even further accelerating in the second half of the year. But now John will add some numbers to this as well to answer your question completely.

Excellent. Yes. In terms of where we're at and what we're looking for productivity, we expect in the back half of the year, to your point, we expect to see our revenue growth accelerate given the fact that we have our new training class that's now productive in the second quarter this year and then we will ramp up over the rest of the year. So the sequential growth rate I mentioned, 25% to 30% in the second quarter, we would see that accelerate in the third quarter. probably about the 40 -- low 40% to 45% range and then in the 50% range into the fourth quarter of the year, which, as you know, is a seasonally stronger year, especially in the U.S. as people have fully exhausted their deductibles. So when you run that math, that's what helps provide some of that back-end growth that you'll see in the model to achieve that U.S. revenue target.

And maybe last on this one, let's also not forget that I think we can say that reimbursement is fully clear and supported from both CMS with the C codes and also from commercial payers. So also this is definitely not a hindering factor as we experienced already in Q1, not to be a hindering factor.

Okay. Fantastic. That's a lot of very helpful color. I appreciate all that. For the follow-up, I wanted to switch over to reimbursement, everyone's favorite topic. Olivier, I guess the question is really around kind of the longer-term strategy for Genio and how you're thinking about a permanent CPT code. And I know in your prepared remarks, you mentioned the AMA CPT panel meeting earlier this month.

We did see the proposed meeting agenda, and there was a hypoglossal nerve stimulation code on that agenda. But from our vantage point, that actually seemed to kind of describe the competitor device versus Genio. So would you agree or disagree with that assessment? And then just any help that you can give us in terms of pathway forward to kind of a more permanent reimbursement coding solution and time lines for Genio would be appreciated.

So I do think that for 2026, everything is very clear now. CMS has the C codes. We know the WISeR program. There we have obtained 100% approval prior authorization approval ratio. And we also know with commercial payers that we are both covered under the CPT 64568 and 64582. So 2026, I do think is crystal clearing going forward and is completely derisked. Now we were also participating during the editorial CPT panel discussion. And of course, there, we were listening and actively participating in this discussion focused on 2027 and even 2028.

So for 2027, we expect no change on the Medicare side. The C-code framework and the physician payment under the CPT 64582 in place and operational. On the commercial side for 2027, just listening to what was discussed and also talking with experts, we do think that the CPT 64568 will be revised and will apply solely to the vagus nerve stimulation, directing all AGNS procedures away from that code and the code would migrate into 64582 code.

Now in going to 2028, and that's also touching to the remark that there was a competitor CPT application for a dedicated new CPT code, which is correct. I mean that was part of the agenda of the editorial panel discussion. So for '28, what we are hearing is that there are two roads in going forward.

One would be there is the move in the direction of CPT codes, dedicated CPT codes for all reimbursed AGNS technologies. The second road would be that there would be a more comprehensive AGNS coding set where also all reimbursed AGNS technologies would fall over. But that needs to be further clarified. Now when it comes to Genio, when we go to a CPT dedicated code, we intentionally did not yet submit this on the agenda of the editorial panel, but we are well prepared, and we will be submitting this going forward.

On the other hand, we will always take a lead from specialty societies, including AGNS since their actions are driven by physicians performing procedures. So the conclusion is 2026, we know that everything is derisked reimbursement-wise. '27, we see it the same way.

Medicare side completely clear from the commercial payers, there are coding in place. It might be that everything is more migrated to the 64582 code. And in 2028, I'm sure that editorial panel will continue discussing. They made it already clear that there will be no orphan AGNS technology and whether it evolves into dedicated codes, we will be prepared for this, whether it evolves to a more comprehensive AGNS coding set, we will follow the lead from society in this. I hope this is answering your question.

[Operator Instructions] Our next question will be coming from the line of John Block of Stifel.

Olivier, the first one is the 241 patients submitted under prior authorization at the end of the first quarter of 2026, can you remind us what that number was at the end of the fourth quarter of 2025, sort of apples-to-apples? And then how long does it take to get those patients through the approval process, which I believe you said is still sitting at around 100% from your vantage point?

Yes. So for leaving Q1, as I was saying, 241 -- when we were leaving Q4, we had approximately 116 patients under prior authorization. And how long does it take? I mean commercial payers, they have up to 30 days to come back with the approval. As a reminder, so far, we have a 100% prior authorization approval rate. And then it depends hypoglossal site to hypoglossal site because we are talking about high-volume sites in getting OR time planned, also getting surgical time because it's not only the site that is high-volume site, also the surgeon is a high-volume surgeon doing other procedures as well next to the hypoglossal stimulation of the Genio procedure. So we see that this varies between 1-month to 3 months before those patients are getting implanted.

Okay. That's helpful color. And then maybe just to pivot, John, pro forma for the European second tranche I think you've got about EUR 40 million, call it, cash, the roughly EUR 26 million plus the EUR 14 million. Maybe if you can remind us what the breakeven point for the company is, your views on cash burn going forward? And then just to tack on the gross margin continues to perplex me. When I look at the P&L, when you guys had EUR 4 million in 2023, your gross margin was 62%. And here we are approaching EUR 40 million in 2026, and it can't get out of its own way in the sort of low 60% range plus.

So what is preventing gross margins from improving as the company has sort of improved the top line? And then how do we think about it going forward and sort of that inflection that you guys anticipate is going to take place in subsequent years?

Sure. So let me start with gross margin. So with regard to gross margin, we did have some issues with production yields in the quarter due to some turnover and some training issues, which have been all resolved at this point. So we expect to see our gross margins increase going forward beginning in the second quarter and for the rest of the year. I think, as I mentioned on the last call, we have our Genio 2.2 new disposal patch and activation chip, which will be a major step function improvement in our gross margin profile. That will be coming online in early 2027. So that will provide us that uplift from the low 60s to north of 70% at that point in time with that improved patient experience plus significantly cost reduced [ profile ] as well. So that's how we're thinking about gross margin.

Then also in terms of the next step-up in gross margin improvement will be driven by the cost reduction on the implants, which we have contractual volume-based pricing as we hit different volume milestones in our contract with our contract manufacturers. So that's the gross margin outlook and that we have a high degree of confidence we'll get to 8-plus percent in our gross margin profile on the back largely of those two initiatives.

In terms of cash burn, we're very focused on managing our cash burn. So as you can see, we held our cash operating expenses actually slightly decreased them from the fourth quarter to the first quarter of 2026, and that's reflective of the incremental 15 sales reps that we added in the U.S.

So we've been very focused on making sure that we're investing strongly in the U.S. commercialization efforts, reallocating capital to that from other parts of the business and really want to basically extend our cash runway as long as possible while supporting the investments in the U.S. commercial organization, which is the growth engine for us and not sacrificing the improvements in gross margin drivers. So that's how we're thinking about it.

As we think about cash operating expenses going forward, we will be -- we mentioned a 5% to 8% sequential increase this year. We would expect somewhat similar increases going forward, although we're not providing guidance, but as we're thinking about it, we want to be very mindful of our cash operating expense. That way, we can get to a revenue breakeven point approximately EUR 150 million in revenue, that allows us at that point to have an 80% gross margin, margin plus through tight cash OpEx management that to get to breakeven and knock down the total cash that we need to get to that point to somewhere in the range of EUR 100 million to get there. So that's how we're thinking about it and looking at managing our P&L levers that we have available to us.

[Operator Instructions] Our next question is coming from the line of Suraj Kalia of Oppenheimer.

John, can you hear me all right?

We can hear you, well, Suraj.

Congrats on a strong start to the year. Olivier, I want to follow up on John's question earlier, right? Your Q2 guidance, U.S. guidance is plus 25% to 30%, 241 patients in the queue as of the end. Obviously, you guys are going to add more patients as Q2 works its way. If we assume 100% approval, just the patients at the end of Q1 would imply about $6 million in U.S. revenues, and that's a 50% sequential jump.

So maybe you can -- if you could thread the needle for us as to what are your core assumptions here? Also, Olivier, maybe, John, in terms of your Medicare patient funnel, what are your expectations for the full year? And I have a follow-up.

Yes. So Suraj, let me start by commenting on the first part of the question. And I think you're totally correct. So we are seeing a strong ramp-up. And I'm not going into Q2 already, but it's clear that with the patient funnel and the pre-authorization in place and also the spillover from Q4 in Q1 and from Q1 and Q2, we already saw this translated in a very strong April. So that is correct.

Now how fast will we continue ramping up further? Again, as I was mentioning, it will all be also defined by the surgical time, the time that we can get because once again, we are working with high-volume sites and high-volume surgeons. But to your point, April already very strong on this one, and it's showing already that the ramp is kicking in.

The other part, I will turn it over to John to answer this one.

In terms of the ramp, I think we're looking at, again, stepping up the ramp in the back half of the year with regard to sequential quarter growth. So as we think about it, first -- second quarter, we're looking at 25% to 30% sequential growth and bumping that up to low 40s and then upper 40s, pushing 50% in the fourth quarter to get to our total number for the year. So that's how we're thinking about the staging of that, Suraj. Hope that answers your question.

And then the Medicare percentage that was the last part of the question. So in Q1, it's around 10% to 12%, still not a minority. We also see that this will continue growing and we are scaling up. And I do think that towards year-end, this will also be more in the range of 20%. But our commercial payers will stay predominant, will be the biggest part of the business, but also with the C-coding in place, I do think that is also completely derisked.

And we already had the two first [ MACs ] that I were very positive, integrating all the C-codes in their policy as well. So we are looking with a lot of confidence into the next quarters of 2026.

Got it. And Olivier, in terms of Genio and Inspire V, what is the dynamic in the field in terms of selection of the device? Because a lot of sites have these Inspire days booked I guess what I'm trying to understand is, do you all see any early signs of patient selection migrating towards Genio? And by the same token, how do you squeeze your way in with Genio? Is it displacing an Inspire case on these AGNS days? Or help us understand the dynamic as it stands currently?

Okay. So Suraj, that was also one of the reasons we recently conducted a market research study with 100 U.S. AGNS implants also to, in fact, do a sanity check whether our launch strategy and more specifically also the referral strategy is really the right approach and is making sense that impacting -- and it was really to our pleasure to see that I do think we can say that by involving sleep physicians in the management of patients, and that starts with patient selection, so CPAP quitting patients, but it also continues post-surgery in patient management. And what we are doing, we go even one step further. When we train physicians, we do not only train surgeons.

We combine this surgeon training together with their sleep physician partners. Now the dynamics between competition and Genio, it's also clear that for now, our investments in DTC are extremely limited. So the majority of patients that are arriving in hospital, they are coming for an AGNS solution, but they are not coming to DTC or Genio at this moment. So where the convert takes place is when they are in the site, and they are explained the different optionalities that currently are, we see that there is already a high percentage that automatically or spontaneously goes to Genio driven by not having an implanted battery, driven also by the bilateral station and software upgrades. So those are the main components that was confirmed in our market research as well.

Now going forward, we will continue focusing on sleep medicine involvement. We see also that we did the first therapy and the first patient activation that this is going extremely fast -- that we don't need to search to find the correct titration that in the majority of patients, the settings are exactly the same as they were seen during the surgery. And this is also giving a lot of confidence to sleep physicians also to refer for the patients.

So if you combine all this strategy is focused on high-volume implanters. We partner them up with their sleep medicine from the beginning. Then we make sure that there is a clearly defined role in patient phenotyping by sleep physicians before patients are selected after clearing their sleep up. And we make sure the sleep physician is actively involved also in post-surgery patient management.

And then, of course, by seeing the first activations, also the ease of finding the correct titration settings, this is giving a lot of confidence. So we will continue with this strategy, and we'll keep our DTC spending very limited.

[Operator Instructions] And our next question will be coming from the line of David Rescott of Baird.

John, I wanted to follow up on the comments around gross margin. I believe you said there was a production yield issue maybe in the quarter that has since been fixed or alleviated. And I guess depending on where you shake out for the year, I guess first part is, is that impact expected to continue into Q2 and then fully revert back in the back half of the year? And I ask that in the context of, again, where you shake out for the full year, you could be somewhere in the mid-60s by the end of the year if you're getting to the upper end of that 60% to 62% range. So just trying to get a sense for what the adjusted maybe cadence looks like as you get through the year on the gross margin? And then I had a follow-up.

Sure. So yes, thanks for the question, David. In terms of the gross margin impact, there will be a slight gross margin impact in Q2 because some of those units that were built in Q1 will run through our P&L in Q2, there will be a slight impact there. The rest of the year, we'll start to see it get back to where essentially we were in Q3, Q4 time frame, which was in the 63%, 64% type range from a gross margin perspective. And then we'll hang out there for the back half of 2026 before we implement the Genio 2.2 disposal patch and activation chip, which will again provide a step function improvement in the first quarter of 2027 up into the low 70s.

Okay. And then I guess just sticking on the P&L here, looking at this adjusted OpEx number for Q1 relative to the guidance for the full year, you annualize the Q1 number, and you're pretty much getting toward that low end of what the full year non-GAAP guide is. So just trying to get a sense for why we shouldn't be anticipating maybe a bigger step-up on a sequential basis as you go through the year on the OpEx line. Is it fair to assume that a lot of this SG&A investment is already in the business? Or is it more of a, hey, we'll step up SG&A as sales increase, but you now have some offsetting factors more on the R&D front? And then as that relates into where you step off when you look into the 2027 time frame?

Sure. Absolutely. So again, we've been thoughtful about managing our cash runway and being disciplined with our cash operating expenses. So from the large driver of OpEx growth is really regarding the investments we made in the U.S. commercial organization. Those have largely been made in the first quarter of 2027. So that will run pretty consistent over the course of the year, which leads to the essentially the 4x on Q1 results on the low end of the guide.

We will make selected investments over the course of the year, maybe being at the low end to somewhere in the middle of that range from an OpEx perspective. But again, we'll be thoughtful and disciplined in our approach there. And there are a number of items in the business that we made significant investments in 2025 across the board, across a number of supporting functions throughout the organization that we fully expect to leverage in 2026 as the organization scales using the existing infrastructure that's been built out in 2025, which then doesn't require incremental investments here in 2026.

So as we think again about 2027, we want to take the same approach into 2027 and try and redeploy as much capital as we can and leverage the noncommercial parts of the organization that have been built out and have the scale and capability to continue to support the business and redeploy that capital into the growth drivers vis-a-vis revenue and/or margin improvement initiatives. That's how we're thinking about it, and we want to be conscientious of that.

I think that was answering the question since the silent. So I don't know, operator, if there are more people lined up for questions.

That concludes today's Q&A session. And this also concludes today's program. You may all disconnect.

Thank you.

Thank you.

Good day, and thank you for standing by. Welcome to the Nyxoah Fourth Quarter Full Year 2025 Earnings Conference Call. [Operator Instructions] Please be advised that today's call is being recorded.

I'd now like to hand over to our first speaker today, Pearson Dennis, Investor Relations Associate. Please go ahead.

Thank you. Good afternoon, everyone, and I welcome you to our fourth quarter and full year 2025 earnings call. Participating from the company today will be Olivier Taelman, Chief Executive Officer; and John Landry, Chief Financial Officer.

During the call, we will discuss our operating activities and review our fourth quarter 2025 financial results released after U.S. market closing today. After which we will host a question-and-answer session. The press release can be found on the Investor Relations section of our website. This call is being recorded and will be archived in the Events section on the Investor Relations tab of our website.

Before we begin, I'd like to remind you that any statements that relate to expectations or predictions of future events, market trends, results or performance are forward-looking statements. All forward-looking statements are based upon our current estimates and various assumptions. These forward-looking statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. All forward-looking statements are based upon current available information, and the company assumes no obligation to update these statements.

Accordingly, you should not place undue reliance on these forward-looking statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 20-F, which will be filed with the Securities and Exchange Commission.

With that, I will now turn the call over to Olivier.

Thank you, Pearson. Good day, everyone, and thank you for joining us for our fourth quarter and full year 2025 earnings call. Let me start by our '25 key milestones and highlights. '25 was a transformative year for Nyxoah. We achieved several defining milestones during the year. In early 2025, in anticipation of FDA approval, we hired and trained our U.S. commercial team, including our first 25 sales reps. We developed our strategic launch plan, worked on securing market access and mapped out target accounts focused on the top 400 highest volume hypoglossal nerve stimulation accounts around the U.S. On August 8, we received U.S. FDA approval for Genio, followed by actively launching our product. We secured reimbursement for Genio across both Medicare and commercial payers, resulting already in first implants and revenue as early as September 2025. We successfully executed on our focused launch in the United States. We trained 145 surgeons in 125 high-volume hypoglossal nerve stimulation accounts, of which 57 already received positive value analysis committee approval, resulting in $4.5 million of revenue generated in Q4. This translates into $720,000 annualized sales rep productivity,during the first full quarter of launch.

From a clinical data perspective, the DREAM pivotal study was published in the Journal of Clinical Sleep Medicine. These data demonstrated Genio's clinical efficacy in both supine and non-supine positions as reflected in our labeling and differentiating us from competition.

Internationally, we continued driving growth in selected markets, including Germany, United Kingdom and the Middle East. We closed 2025 with a global gross revenue of EUR 11 million, driven by strong Q4 U.S. launch momentum.

Now let me dig in deeper, starting with our commercial update. The fourth quarter marked our first full quarter of U.S. commercialization following FDA approval, and we are excited with the first launch results. Let me share with you the key leading indicators that we are tracking to. As of December 31, 2025, with our 25 sales reps, we focused on 125 out of the 400 top HGNS accounts in the U.S. From these accounts, 145 surgeons were trained. We completed 120 value analysis committee submissions and received 57 approvals already with no VAC rejections to date. U.S. reimbursement has been consistent for Medicare and large commercial payers to date. For the past months, I've had the chance to meet multiple surgeons and fleet customers across the U.S., hearing consistent positive feedback on Genio's unique approach and the optionality we now offer to patients and physicians. Surgeons are attracted by the bilateral stimulation, the single incision procedure and the consistent therapy efficacy across all sleeping positions, which makes Genio unique on the market. In their interactions with patients, they highlight the patient-centric design, including the batteries-free implantable, full-body MRI compatibility and no need for resurgery due to battery depletion or software upgrades.

In addition, sleep physicians note that the first wave of activated patients in the U.S. are providing strong positive feedback on therapy outcomes. From a reimbursement perspective, ahead of FDA approval, we worked to align Genio coverage with the broad framework of hypoglossal nerve stimulation therapies across both commercial payers and Medicare. I'm pleased to report that Genio has been consistently reimbursed by both commercial payers, which represents approximately 90% of our business and Medicare, which represents the remaining 10% of the Genio business during Q4. Recently, there has been a lot of discussion and communication regarding HGNS reimbursement overall. As is typical for a relatively new product category, in combination with an expanding landscape where Genio enters the market, procedural coding practices continue to mature. In February 2026, CMS established new interim C-codes for HGNS that facilities will use when billing for traditional Medicare patients, including specific codes, 8011, 12 and 13, which apply to external power devices, including of Genio osystem. Last Friday, CMS indicated that the new C-code 8011 used for the Genio implant would be reimbursed in the hospital outpatient department at $31,526, in line with 2026 coverage for CPT code 64582. This also means that there is no reimbursement difference between the Genio system and competition. Staying with Medicare, the introduction of C codes does not change how surgeons build their physician fee for Medicare procedures. Surgeons are responsible for selecting the appropriate CPT code and potential modified use. Given recent CMS guidance, we expect surgeons will elect to use CPT 64582 for the physician fee.

Let us now to commercial payers, which represent approximately 90% of our business. Claims continue to be processed on the CPT Code 64582 or 64568, depending on payer policy, contractual terms, documentation and individual case review. To date, we have seen strong trial authorization outcomes across cases submitted to commercial payers, including many of the largest in the United States.

In conclusion, we view the current reimbursement agreement as a normal maturation of an established therapy. With the recent clarity on the facility fee of $31,526 for the Genio C code, we are confident that it will not have any negative impact on further Genio adoption in going forward. We remain actively engaged with specialty societies and coding authorities to support long-term dedicated HGNS CPT codes.

From an internal update perspective, while the U.S. is the growth driver, international markets continue to provide a consistent revenue contribution. Our goal is to ensure each of our international markets are profitable with Germany being the first that has achieved this goal.

In summary, entering the U.S. market in 2025, which is the largest HGNS market in the world, completes our transition to a commercial organization. The momentum we see in the U.S. launch reinforces our confidence in the opportunity ahead.

With that, I will now turn the call over to John for a detailed overview of our financial results.

Thank you, Olivier. Starting with the fourth quarter of gross revenue was EUR 6.3 million before EUR 700,000 of revenue deferrals, mainly due to disposable patches, which are delivered over time, resulting in net revenue of EUR 5.6 million compared to EUR 1.3 million in the fourth quarter of 2024. This growth was driven by our U.S. commercial launch, which resulted in approximately EUR 3.5 million of net revenue in the fourth quarter of 2025.

Gross margin was 64% in the fourth quarter. Total operating loss for the fourth quarter of '25 was EUR 18.6 million compared to EUR 18.3 million in the fourth quarter of 2024. Notably, operating loss remained relatively stable year-over-year despite significant commercial investments made to support our U.S. commercial launch.

Now let's turn to the full year 2025 results. Gross revenue was EUR 11 million before EUR 1 million of revenue deferrals mainly due to disposable patches, resulting in net revenue of EUR 10 million compared to EUR 4.5 million in 2024 or 122% year-over-year growth.

Gross margin for the full year of '25 was 63%. Total operating loss for the full year 2025 was EUR 83.5 million compared to EUR 58.8 million in 2024. The increase in total loss reflects the acceleration of U.S. commercialization activities in preparation for commercial launch.

Our cash position as on December 31, 2025, which includes cash, cash equivalents and financial assets totaled EUR 48 million.

Now as we turn to revenue guidance, we expect U.S. net revenue for both the first and second quarters of 2026 to grow 25% sequentially. This sequential growth in the U.S. reflects continued surgeon training, additional value analysis committee approvals and growing surgeon adoption. International revenue is expected to follow typical seasonal patterns.

With that, I'll now turn the call back to Olivier for closing remarks.

Thank you, John. For 2026, our priority is clear, continue executing on our U.S. commercial launch. To that end, we increased already our sales force by 15 sales reps and 3 sales directors in the first quarter of 2026, bringing us to a total of 40 sales reps, covering 200 of the top 400 hypoglossal nerve stimulation account.

During 2026, from a clinical perspective, we are looking forward to see our 12-month ACCCESS study data on complete concentric collapse and subsequent PMA supplement submission, potentially leading to a U.S. label expansion in early 2027. As a fast-growing company, we are expanding our internal manufacturing footprint to further strengthen our competitive position and improve our gross margins. We expect our 2026 execution to translate into a very strong financial profile as we gain market share in the U.S. Thank you for listening, and your continued interest and support for Nyxoah.

With that, I would now like to open the lines for questions and answers.

[Operator Instructions] Our first question comes from the line of Adam Maeder from Piper Sandler.

Congrats on the progress. 2 questions for me. The first one is just on some of the leading indicators or metrics that you shared Olivier, if I heard correctly, you have 120 VAC submissions that were made, I think, as of December 31, last year, and I think 57 accounts activated. Can you just kind of help bridge us for the remaining 60 or 63 VAC processes and kind of where those stand? When should we expect more accounts to go active? And just talk about the funnel for new accounts as we move towards that 400 of hypoglossal stimulation account target? And then I have a follow-up.

Thank you, Adam. So to your point, we have submitted 120 VAC submissions, already 57 are approved. The other ones, they will be approved, and we already saw the first ones being approved in Q1. As you know, not every hospital has the same time line when it comes to VAC approvals, but we were extremely pleased to see already the first 57 during Q4. So you can expect the remaining to start being approved during Q1. So that is already, I think, answering the first part of your question.

The second one is regarding to the sales force and how many accounts we are covering, many new accounts we will open in going forward. As I mentioned during my call as well, we already increased our hiring of 15 additional sales reps. So we went from 25 to 40. And with that, on average, each of those 15 will add 5 new accounts, so that can go up to 75 additional accounts, resulting in 200 out of the 400 high-volume accounts that we will be covering during Q1 and during also Q2. Hope this is answering your question.

Very helpful, Olivier. For the follow-up, I guess I'm going to ask about complete concentric collapse and the ACCCESS study. And if I heard correctly, I think you're targeting early approval in 2027. Maybe just help us understand when we're actually going to see that data presented. I assume that's this year. And if you could just maybe put a finer point on submission timing. I think that's a PMA supplement, but wanted to confirm that.

Yes. So yes, it is a PMA supplement that we will be submitting. Now coming back on timing, we had to wait for 12-month data. So by the end of June, we will have 12-month data of all patients. Then we will go into the analysis of the clinical data that will take up to 30 days. So by the end of July, we should really have a good view on the data are looking like and also using this to prepare our PMA supplement submission. There, we are confronted with the regulatory time line that we cannot really change and influence. So that's why we calculate it more or less 1 quarter, so 90 days, that we will do once we have submitted our data, and that's how we end up entering Q1 2027 to obtain the approval. When we will we publishing the data? I mean, this is something we have to submit. We will do this as soon as we have our data. So by somewhere July and then depending on the acceptance in the journal, we will definitely publish this data and present them during one of the congresses that we will attempt.

Our next question will come from line of Jon Block from Stifel.

John, maybe I can just start with you. I mean, obviously, helpful on some of the guidance figures. But any more color you can give us around the cash burn rate either for the quarter, 1Q even on an annual basis when we start thinking about 2026? And then I'll just ask a follow-up.

Sure, Jon. Thanks for the question. In terms of cash burn, we're looking at approximately EUR 20 million cash burn here in the per quarter in the near term. We -- recall in the fourth quarter, we raised capital vis-a-vis PIPE as well as convertible debt provided us additional cash to get into the first quarter of 2027. So with the capital we have on the balance sheet, and the cash burn, which, again, EUR 20 million here in the near term, which will decrease as we gain revenue traction here in the U.S. that will provide us the capital again into the first quarter of '27.

Okay. Got it. Very helpful. And then let me pivot. Olivier, maybe for you, maybe I could throw a couple of questions your way. The first 1 is, I think your compeititor has been pretty transparent about pursuing their own code and maybe going down that road for Jan 1 of 2028. I think the C codes bridge you for a little while, but your thoughts on pursuing your own code, what that will entail and what that may mean. And then can you give us an implant number, the number of implants that were done maybe as of the end of the year or any even color that you're willing to give us into 2026, because clearly, of those 57 accounts activated as you should be. I mean you're selling into the shelf a little bit when we start thinking about the revenue number.

Yes. Thank you, Jon. So yes, when it comes to the reimbursement coding, I'm finally pleased that we see that there is progress made that there is clarity also on the facility fee and that we fully understand what the use of Code or an interim C code means and how it's impacting also business going forward. Yes, also on the fact that we would like to evolve to our own coding, and there, we are following, in fact, the same pathway forward as competition is doing as well. And I do think listening carefully and interacting with AMA and also listening carefully to what is going on is that there will be a dedicated coding for Genio also in place, most likely somewhere beginning 2028. But in the meantime, facility fee is clear. We are now waiting for the physician fee, also although physicians and experts are telling us there that they don't expect many differences to how it used to be, meaning using the previous CPT 64582 coding also to calculate the physician fee. So that is one aspect.

Second, number of implants. We decided in our leading indicators not to communicate on the precise number of implants. But on the other hand, I do think it is relatively easy also to get a good estimate when you know that we generated $4.5 million of revenue in the U.S. in Q4. And you also know what the average prices is for the system being $25,000. So that's also, I think, an easy way forward to get your answer there. But in our KPIs, we don't give and we do not provide clear implants numbers. I hope this is answering your question, Jon?

Yes. Okay. I mean I get the math of the ASP and the revenue, and I can do that. But again, some are sitting on the shelf, right? So you were previously giving implants. I guess I'm trying to just get more granular on how many implants were done, not how many units were sold, of which a subset is sitting on the shelf. But I could follow up with you offline.

No, no, but I can -- I think it's an important question and topic that you mentioned. I do not want to avoid this. So first of all, it's clear that we have no policy in putting products on the shelf. We also clearly don't do any consignment. I just want to point out that there is also no consignment. And the way we -- our sales force is operating in the field on business. When we train surgeons, they come with pre-identified patients. Once they have these patients, most of the times, they are coming with 3 to 5 patients. And based on this, we make sure that we provide them with that number of implants, and we always at 1, maximum 2 implants depending whether it's 3 or 5 cases [ they're ] prepared so that there is some backup in case something will go wrong. And I think -- I hope to answer your question more clear in that sense, Jon, because I do think it's important. We are not lowering shelves. We are implanting patients.

Our next question will come from the line of Suraj Kalia from Oppenheimer.

Olivier, can you hear me all right?

Yes, perfect.

Perfect. Olivier, congrats on all the progress. Olivier, I just wanted to follow up on the previous question, so that I get my bearings right. Your competitors' key approach. I hope you can hear me, there's some background noise.

Yes, there's some police cars driving by. My apologies.

So your competitors' approach has been like to have minimum 4 to 5 units upfront sale when a new site is added on. And the larger sites, our field checks tell you can have 10, 12 implants on the shelves. So Olivier, when you say a new site comes online with the 3 identified patients, is your approach also really about 4 to 5 unit upfront sales, really for that matter? That's the right way to think about it. And by the same token, I'm curious how in the high-volume centers as LivaNova also comes online, do you think this dynamic is sustainable of respective inventory of each player on the shelf. I know it was a long question. Hopefully, you've got the gist of it.

No, I will start by answering the first part. So as I was saying, we treat patients, and we do not want to load shelves. I keep insisting on this. And with the example that you used, when we have 3 patients that are lined up for implants, we are selling 4, maximum 5 devices depending on what the surgeon prefers as a potential backup. So that's what we are doing. So we are not additionally selling more devices that are sitting there on the shelf. We are not doing this. So I do think your calculation in the example was correct, 3 patients lined up for implant. We sell 4, maximum 5, just to make sure there is some backup just in case. That is one aspect.

Second thing, you touched on LivaNova. So I was also carefully reading and hearing today's announcement, and I want to congratulate them with this. But it also means that they are not launching actively currently, but they are waiting till somewhere Q1, if my information is correct, or somewhere beginning '27 to launch. Now what we do expect, if you look a little bit at the technology is that you will have a clear differentiation, there is Genio, bilateral stimulation, external variable component, single incision, and then there will be 2 players with a pacemaker platform that will be more alike and most likely also more be considered when a compact physician in making patient choices or selection, which patients will get what. But I feel very confident with our Genio differentiated approach that we can continue also rolling out successfully in going forward and that patients also will know what to choose, a single incision with bilateral stim versus a pacemaker.

Fair enough. And 1 follow-up, Olivier. The 57 or so sites that you all have trained, Olivier, admittedly, it is early. But what are you seeing as the key driver for Genio in these sites? Like what is the key reason that physicians are asking, hey, I need this also on the shelves. And the reason I ask is, look, there have been a chatter about men with beards not having -- not wanting Genio so on and so forth. So just give us an idea about what you're seeing in the field to set the stage for market share approximations, at least between the 2 current players?

Thank you, Suraj. So maybe starting by clarifying something. So we have trained more than 57 accounts in the U.S., just to be very clear about this. we have already 145 surgeons and they represent or they're active in 120 accounts of the 125 high-volume accounts that we are targeting. So we're trained in 120 accounts, the 57 number is the number where we already have a full approval, where the VAC is approved, and where we actively were doing business during Q4. Just to clarify this one.

Then answering the question on why are surgeons choosing Genio, and I think you can summarize it in 3 major buckets. First of all, there is the optionality that we are providing by breaking the monopoly that was existing and not all patients like or accept a pacemaker. Second, there is the Genio differentiation. So a clear single incision implant technique, something that resonates extremely well with surgeons to having a single incision compared to multiple incisions. And then last, for the surgeon, also the bilateral stimulation and the related quality of airway opening with a beautiful [ tongue hold ] solution. This is something that we are hearing back constantly also with staying efficient in complex airway obstruction. So those are the 3 things. I hope this is answering your question.

Yes. Thank you.

[Operator Instructions] Our next question will come from the line of David Rescott from Baird.

This is Tommy Han on for Dave. I was wondering if you guys would like to put a finer point on your assumptions and guidance around new account adds versus increasing utilization in your existing accounts relative to the Q4 exit rate?

So as I was mentioning, we have a focused approach with the 24 salespeople starting immediately post FDA approval, we were able to reach 125 out of the 400 high volume. Today, we added 15 reps. So now we are already reaching out 200 out of the 400 accounts. Then next to this is we have already trained 145 surgeons. We have surgeons lined up for training. There are even a waiting list. So we are doing trading almost every weekend across the U.S., and we will also significantly increase the number of accounts we can do business with, and we can implant patients. So that can go up all the way to 200. But in the meantime, of course, there is each time the VAC submission that takes place, it is depending a little bit on by account by account, how fast it can go. We see that it can happen sometimes in 2 weeks, sometimes it takes a month, sometimes even longer. But what you can expect and gradually scaling up is that over time, and when I define overtime, by the end of Q1, we should be covering all the way up to potentially 200 implants accounts where w'ere present.

Great. And I was wondering if you guys wanted to provide a little bit more color around OpEx guidance and gross margin guidance for '26, and what the drivers are behind that? And separately, maybe for procedures performed so far, can you help us understand where those patients are coming from? Is it those who are expecting to get another HGNS device or more so people who have been waiting on the sidelines?

Yes. So I will take the last part of the question and the first part, I will hand over to our CFO, to John. So the last part, where those patients are coming from? It is clear that in those high-volume accounts, there are well-established referral networks, and we see patients being referred the moment that they arrive with the surgeon. So today, with Genio, there is optionality, patients are proposed both technologies, and we see that a high number of these patients are choosing for Genio, for the reasons I mentioned from a surgeon perspective. But when it comes to patients, what is driving them is that, in fact, Genio is designed, so patients can forget they even have an implant. So it's a very minimum invasive surgery, and it's also designed to [ evolve ] with patients. As an example, upgradable software, an intuitive patient app and no need for resurgery. So that is where we see a lot of patients being very appealed by when they're confronted and being proposed and explained what Genio can do. So that is one aspect. And going forward, it's also clear that we are establishing strong relationships with sleep physicians and that we are also working on referring our own Genio patients. John, with that, maybe on the gross margin.

Yes. Thanks for the question there, Tommy, on the model. In regards to gross margin, I would expect gross margin to increase slightly over the balance of the year, really due to increased sales volume and being able to spread the overhead over more units. So you'll see a slight increase in 2026 as we move through the year. The major step function increase in gross margin that you can expect to see is probably more in early 2027 when we launch our next-generation disposable patch activation chip or Genio 2.2 specifically, that will allow us to have an enhanced patient experience plus also allows us to significantly reduce the cost of the disposable patch going forward. So the next step function up. into, say, the 70% range will come in 2027.

In terms of OpEx, we don't provide specific OpEx numbers in terms of guidance, but let me give you some color here, if I can, to provide some direction. In terms of our R&D expense, which includes things like quality, regulatory, medical affairs, clinical, in addition to the true R&D spend, what you're going to expect to see there is that number to go down over the course of 2026 sequentially on a quarterly basis as some of the investments that we made in 2025, getting ready for commercialization will start to fall off over the course of 2026.

In regards to SG&A, the main driver there, Tommy, is really around U.S. sales expansion. So as Olivier mentioned, we expanded by 15 sales reps in 2026 in the first quarter. So you can expect our Q3, Q4 run rate to increase due to the increase of these 15 sales reps as well as their 3 respective sales directors. So that would be the major investments we make in the SG&A sphere this year, all the other infrastructure investments, we're going to leverage those as we build those out in 2025. So hopefully, that's helpful as you think about the model, and that's what we're looking at for 2026.

I'm not showing any further questions at this time. With that, this concludes the question and answer session. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.

Good morning, everyone, and welcome to the 44th Annual JPMorgan Healthcare Conference. My name is Varun, and it is my pleasure to invite on stage today Nyxoah, represented by their CEO, Olivier Taelman. Please put your hands together for Olivier.

Thank you. Let me start by thanking JPMorgan for the invitation. My name is Olivier Taelman. I am the CEO of Nyxoah. Nyxoah, a medtech company offering an innovative solution by neurostimulation to help patients suffering from obstructive sleep apnea. We are listed on both Nasdaq and Euronext under the ticker NYXH. Currently, we are going through the most exciting time in company history since we have obtained in August last year, FDA approval, and we are actively launching our product to help patients in the U.S. suffering from obstructive sleep apnea.

Our vision is to make sleep simple. Now before I will walk you through the technology, the commercial updates, et cetera, I would like to start by sharing how we at Nyxoah, how we see sustained value creation. Everything starts with the addressable market. And if you look at obstructive sleep apnea, it is a huge market. There are a lot of people, and we are talking up to 450,000 to 500,000 people that are eligible for the Genio technology in the U.S. only. That represents roughly $10 billion market opportunity. If we would have been in pharma, we would talk about blockbuster potential.

Next to this, it's also a largely underpenetrated market. Today, not more than 8% of the total eligible to treat patient population will actually get therapy. It's a fast-growing market. And we as Nyxoah, as I was already saying, we are currently actively launching as a second player in the space in the U.S. With Genio, we have a completely differentiated patient-first technology with a unique bilateral mode of action. I will come back to this later in my presentation in more details. Of course, we do have robust compelling clinical evidence coming from our clinical pivotal study called DREAM.

In the meantime, we already treated more than 1,000 patients outside of the U.S., across Europe and in the international business. We are commercially available in both Germany and U.K. and also recently in the Netherlands and in the UAE. And as I started my presentation by saying it is the most exciting time for our company because we are heavily -- we are intensively launching in the U.S. In the U.S., we already can also say that we have a reimbursement code secured, and we have both received already coverage from private payers and also from CMS.

Now before we talk a little bit more about why do patients need treatment when they suffer from obstructive sleep apnea, it also starts by touching a little bit further on what is exactly sleep apnea. It is a chronic disease. It, in fact, enable the patient during the night to breathe properly because they will have several collapses of the upper airway that can vary from 10, 15, 20, 30 all the way up to 60 obstructions of their upper airway every hour during the night. This all is categorized in mild sleep apnea, then we talk 5 to 14 obstructions every hour. You become moderate once you have 15 all the way up to 30 obstructions and you get to severe apnea once you have more than 30 obstructions every hour.

As you can understand and imagine, this is also associated with a higher mortality risk. And linked to the higher mortality, there is also the increased risk of comorbidities. And that is the main reason why patients suffering from OSA, as we like to refer to when we talk about obstructive sleep apnea, need treatment. The risk of stroke doubles, cardiovascular risk is going up by 5 and the risk of heart failure simply triples. Next to this, there is also a high prevalence in other key chronic diseases. I always like to highlight one. I'm sure you can see there are more than one, but I'd like to highlight one, and that is type 2 diabetes because up to 72% of all type 2 diabetes patients are suffering from OSA.

Also, there is a clear need to further invest and investigate clinically what the effect would be if we were able to stabilize the OSA of these patients during the night, give them back a good night sleep with a good oxygen flow, also on the glucose levels in managing their diabetic disease. But more to come on this one later. Now we know and understand why patients need treatment. But the next question is, what are the current existing treatment options. CPAP, and I'm sure you all know someone who is wearing a mask, a CPAP mask still is the golden standard in the treatment.

Next to CPAP, there are mandibular advanced devices. What we see with the Mandibular Advanced devices is that the predictivity of the efficacy of the therapy is rather low, and we also see that it's associated with a high out-of-pocket cost for patients. When we talk about CPAP, I think there, the biggest issue is compliance. There is a patient quitting percentage going all the way described in literature from 29% all the way up to 83%. On average, we see that up to 50% is quitting using their CPAP on annual level.

Next to the CPAP and the Mandibular Advanced devices, there is traditional surgery. What we learned with traditional surgery is that it's highly invasive. It's an extremely painful surgery or more specific the recovery after the surgery. The success rate is rather low, 30% to 60%. And we also are seeing that it's reoccurring. So once you have surgery, over time, you will be in need for again having surgery. And we're also seeing that with the younger generation of ENT surgeons, this is no longer applied so much.

And then, of course, there is unilateral hypoglossal nerve stimulation. Unilateral hypoglossal nerve stimulation, today, it's associated with an implantable battery, a kind of pacemaker platform technology. And just by saying this, this is already one of the hindering factors that patients will get a battery implanted on the chest, and that goes hand-in-hand with MRI compatibility restrictions. Now -- these are the options. And as you can understand, there is a clear need for a totally differentiated patient first technology. And that is the gap that we are filling with our Genio technology.

A little bit more details on Genio. So first of all, the Genio technology contains 2 key components. You have the implantable or the implantable stimulator as we like to refer to, and then there is the smart wearable component. If we focus a little bit first on the implantable stimulator, and you can see it on the slide, bottom right, you can see that it's a very elegant device. It offers bilateral stimulation. So we have 2 peddles, a left and a right peddle. There is no implanted battery. The technology of the implant is totally passive, and that brings immediately a huge advantage for the patient that it's offering them a full body MRI compatibility.

Next, driven by the bilateral stimulation, we also learned that we are the only company with a clearly differentiated clinical evidence showing that we maintain our efficacy also with more difficult airway obstructions. But I will touch a little bit more on this once we are touching the clinical evidence in the upcoming slides. Single incision, minimally invasive. It takes less than 60 minutes for the surgeon to implant skin to skin. After the implant, that is done in a daily hospital visit, you come in, in the morning, you leave the same day, less than 60 minutes, as that was already mentioned, patient goes back home, the wound or the incision is healing and roughly 5 to 7 weeks later, the patient is coming back to get the technology activated.

And in order to activate the technology, we are talking about a smart sleep wearable. Again, as you can see on the drawing, the patient is wearing his sleep wearable under the chin. It is attached to the body with an adhesive. In the morning, of course, the adhesive is removed and the wearable component will be charged and will be good to go for the next evening. If you compare this with a CPAP mask, if you compare this with a pacemaker technology implant, I'm sure you all agree that this is the most elegant and also the least invasive solution that currently is available on the market.

I was referring to a smart sleep wearable and why is it smart? It is smart because it is containing the software or the intelligence of the system, which is providing control for the physician when they start programming, but it's also providing a further optionality for patients once they are implanted. It's also capturing the data that patients are getting and also the impact on how they get their sleep quality back.

Next, it's also containing the battery. So the implantable part, as I was referring to earlier, is a total passive device that is activated once there is true induction and energy transfer coming from the smart wearable, activating the device once patients are sleeping. Now next to the wearable component, the patient also has access to what we refer to as an intuitive app. And what can they expect from the app? First of all, it's monitoring them during the sleep. Next, that it's capturing data, data that can be sent back to the physician, data that can be sent back and used by the company to further innovate and data that can even be used for health care economic figures to also see what it means when you start treating patients and you give them back a good night sleep and to give you one of the most obvious examples also how patients are returning to work or no longer suffer from daily sleepiness.

And then last, there is even the option for a patient to personalize his or her stimulation. And when I'm saying this, it is in predefined boundaries, of course, always controlled by the physician, but it gives them a little bit more option to find their optimal comfort. And by doing so, we are really empowering the patient and definitely it helps driving compliance. Just to give you some background on compliance, we already recorded more than 87% compliance data from patients and also 92% patient satisfaction.

Last, and I think also not to be neglected, people suffering from obstructive sleep apnea, they move, they travel, they want to go out with friends and family. So if you look at the device that they are carrying with them, it is the wearable component, weighting less than 12 grams. And you also have the charging unit comparable in fact, like sometimes when you put your phone in a charging unit. We have an implant for life concept, meaning that the implantable stimulator who is ceramic encoated, guarantees already a longevity of 15 years.

And that is only what we measure today. So it definitely doesn't mean that the device will stop working after 15 years, but that is what is reflected in the label. So that is the implant for life concept we refer to. And then there is a scalable technology platform. I talked already about smart wearable. Now what is the key advantage of a smart wearable is that there is no longer need for resurgery when there is, for example, a software upgrade available. The patient can simply have this push through to the smart wearable, a little bit comparable like what we do with smartphones when there is an upgrade available.

All this, I hope you agree, is bringing back to a totally differentiated, but patient-first technology. Now once we describe the technology, I think the next thing for a med tech company, which is crucial is building robust clinical evidence. So here, we have our pivotal study that was conducted in the U.S. We call it and refer to this as a DREAM study. It is published in the Journal of Clinical Sleep Medicine. And the 2 major outcomes that I would like to share already in the beginning is safety and efficacy.

When we look at efficacy, it's clear that we touched our primary and secondary endpoints in both the responding rate for the AHI, apnea hypopnea index and also the oxygen desaturation index. So there, we see results up to 64% and more than 71% for both. So the conclusion is Genio reached its primary and secondary endpoints in the clinical pivotal study.

Now from a safety perspective, which is also important, you see an overall serious adverse event ratio of 8.7%. Now putting the 8.7% a little bit in perspective, comparing with other neuromodulation solutions, there we see that it's a very low severe adverse event rate because on average, we see SAEs between 15% all the way up to 22%. So with 8.7%, I think it's clearly linked also to the fact that we have a single incision procedure that is also associated with less adverse events. If we look at the most common AEs, they can be brought back to the fact that it stays the surgery with an incision of roughly 4 to 5 centimeters in the chin fold, but we also see that those side effects that they are vanishing roughly 2 to 4 weeks post surgery.

So conclusion on this one is we have compelling evidence and we reached both the safety and efficacy primary and secondary endpoints. Now what is important for patients? And what is important for physicians when they are offering or making, in fact, the choice for their technology. What is crucial is, of course, that you get rid of your obstructions that you get back to a normal sleep. And what we are seeing is that we have a median AHI reduction after 12 months of more than 70%. I was mentioning that with Genio, we are the only ones who can guarantee also an efficacy in more complex airway obstructions.

And this is what you can see in this clinical study also when patients are sleeping on their back or in a supine position, we can also guarantee a very high reduction of airway obstructions all the way up to 67%. And then last for a patient, it's crucial that you are protected from your comorbidities, your risk for stroke, your cardiovascular risk. And we see that 82% of all patients treated with Genio, we are able to bring their AHI back below 15. And why is this 15 such a magical number? Once you are below 15, in fact, your morbidity is related or is exactly the same as people who are not suffering from obstructive sleep apnea. And that's what Genio can offer in 82% of all implanted patients after 12 months.

That brings me to the next chapter in our company history, and that is commercialization. So when we look at commercialization, we did our commercial proof of concept in Germany, in the international markets. And I will keep it also very high level. But what we did is everything starts by obtaining reimbursement for your technology. In Germany, we managed to get reimbursed, but not only reimbursed, we got exactly the same reimbursement as competition, which gives us immediately the big advantage that we can differentiate on technology and that we will also, through the reimbursement, will align on pricing.

Now the next commercial strategy that we applied was how can we enter the market as a smart follower, meaning we go where there is already a lot of experience with hypoglossal nerve stimulation. We position our technology, and we see how the uptake is and the embracement of Genio with surgeons and patients. And guess what? By doing so, in less than 24 months, we were able to capture 25% market share in high-volume competitive centers where we simply entered and positioned our technology. We did not invest at that moment in any DTC activities. It was mainly driven by giving surgeons, physicians and patients optionality and option to choose. It resulted already in 25% market share in high-volume competitive sites.

Now next, we are selectively expanding internationally. Next to Germany, you have the surrounding countries like Switzerland. We also started in '25 in the U.K., in the Netherlands, in UAE. But our aim stays focused on the U.S. and why? Because the U.S. today is simply representing the largest market opportunity with close to $1 billion of sales already coming from hypoglossal nerve stimulation.

And that brings me to the next slide, how do we enter the U.S. market. So we took the learnings internationally under our belt. We kept going for a smart follower strategy with a focused launch where we are focused on 2 key pillars. One is the high implanting ENT surgeon. We learned that in the U.S., you have approximately 400 sites that are generating 70% of the total HGNS revenue. So that's where we want to go and where we will, in fact, be present.

The next thing that we also saw was that patients are referred by sleep physicians or sleep pulmonologists to be more precise. And what we did and differentiated also from competition is that when we train our ENT surgeon, we do this hand-in-hand with their key or their most largest sleep physicians by bringing them together to the training, discussing patient phenotyping and then making sure that also the sleep physician understands what his or her role is post implant.

We have Nyxoah dedicated commercial team. Today, we are roughly 60 people. Of the 60 people, we have 40 territory managers, sales reps, whatever you would like to call them, we like to refer them as territory managers. And with those 40, we can already cover 200 high-volume sites in the U.S. out of the 400 high-volume sites that are existing. Our plan is to scale up on a quarterly base and to each quarter add a cohort of new territory managers so that by the end of the year, we can cover all 400 high-volume sites in the U.S.

Next to the territory managers, we have a dedicated market access team that is focused on helping also on the reimbursement preparation with the hospitals that also helps in the value analysis committees preparation. There is also a small marketing team. And of course, there is a field training and education team that is ensuring high-quality implants and also helping sleep physicians with the correct patient phenotyping.

Reimbursement has been a hot topic in the last days. There was a lot of questions around reimbursement. What we did at Genio is we start preparing our reimbursement already in 2024. And I'm happy to say that we have established a CPT code 64568 that is recognized by payers for HGNS. Today, when we look at the commercial payers and just to quote a couple of the big names that already reimbursed our technology, Blue Cross Blue Shield, United, Anthem, Cigna. So far, we have 100% acceptance of all the pre-authorization files that we have submitted.

And if we look at CMS, also there, we can say the same thing that we have obtained reimbursement from the majority of the MACs already where we did our submissions. So I do think we can conclude by saying that we also derisked the reimbursement. I'm coming -- I'm getting close to the end of my presentation, but I do think it's very important to share with you what you can expect from Genio and from Nyxoah in going forward.

And I would like to start in the middle of the slide with FDA approval. Once again, we have obtained this in August last year, and we have just released our first full quarter of results in the U.S. And I can tell you, they were extremely exciting. Extremely exciting, we see that we have trained close to 150 surgeons. We have happy patients. We see the patients that are activated already reaching out to their surgeons saying how pleased they were and how happy they were that they have chosen for Genio.

But in going forward, we also invested in a clinical study, very much focused on a specific patient population called CCC or complete concentric collapse patients. They represent roughly 30% of the entire OSA patient population. And currently, they are contraindicated for HGNS. With Genio, we already have them on label, so we are treating them outside of the U.S. In the U.S., we just closed the enrollment in a trial that we called ACCCESS. We will be showing 12-month results in June this year, and that should also result into a label expansion for U.S. patients as well suffering from CCC. There is further geographic expansion. And then, of course, there is innovative leadership.

So today, we are actively investing in incorporating the learnings and in making sure that by enhancing and advancing our technology, we can even continue increasing the respond rate with Genio. We are looking at the wearable component to make it even more patient ergonomic. We are looking how can we further stimulate different nerves like the Ansa Cervicalis stimulation, for example, also to increase the current patients that are not yet responding to hypoglossal nerve stimulation. So a lot of excitement ahead of us.

And my last slide, and I'd like to start -- or I'd like to end with the same slide as I started with, how do we believe of Nyxoah's future success in creating sustained value. Now obstructive sleep apnea, a huge market, $10 billion market opportunity in the U.S. alone, underpenetrated, fast growing. Nyxoah entered as a second participant, and we are breaking a monopoly, a differentiated technology. So we are bringing optionality to patients, and we see the first very successful momentum built in the U.S. We have evolved as a company from a clinical stage all the way into a fully commercial global public company. We are definitely not experimental because we already treated more than 1,000 patients in Europe.

And then, of course, you have the FDA approval that is finally unlocking the Genio potential for U.S. patients. We shared our numbers on Monday. And as I was saying again, I think we have beaten all expectations in the first quarter, and we do realize that it's just a start. But as we like to say, it's better to start strong than to start weak, and we are extremely excited in looking forward what 2026 will bring. Thank you for your attention, and it was a pleasure talking and doing this presentation.

Thank you, Olivier. I think we've got a few questions that have come in online. and I'll read them out. So the first question is asking more about the initial U.S. commercial outcomes. Would you potentially want to make a comment on that? And are you pleased with what you've been seeing there?

Yes. So the short answer is yes. And I think I already alluded to this that the first full quarter, it was a pleasure to see all the excitement with surgeons. We have trained almost like 150 U.S. surgeons in all those high-volume implant sites. We have already sold in the U.S. in the first quarter, $4.5 million. We see the first positive patient reactions after being activated. So the short answer is yes. There is a lot of momentum, and extremely excited.

That's amazing to hear. The next question we have is, who are the typical patients who are getting Genio? And are there any specific patient demographics that stand out at this point? Are the patients asking for the device? Or is it more of the physicians steering the patients towards the device at the moment?

Yes. No, and it's an excellent question. So first, who are the patients that we are seeing. It starts by what we refer to as low-hanging fruit. We have a high number and that it goes from 15% all the way to 20% of patients that are simply saying, I do not want to have an implanted battery on my chest. I don't like this at all. So they have now the option to go for Genio. So that's already a first group.

The second group are the patients who are saying, what about clinical evidence? What about the fact when I sleep on my back? What about the fact when I have a lateral wall collapse, can I be protected? So that's the second group, driven by clinical superiority, if I can say it like this. And then the third group that we are seeing, it's more linked, in fact, to the elegance or the minimum invasiveness of our technology. And there, we see women that are saying, I don't -- again, do not want to have a visible scar on my chest.

Summer when I go to the beach, I don't want to be looked at as someone who has a pacemaker. We also see younger patients who are saying, I do realize what it means to get an upgradable platform. I don't want to go back to the hospital. I don't want to be explanted and implanted with something new in order to -- just to benefit from software upgrades. So that's also what we are seeing. And then, of course, last, and I think it's also part of the question, we see that when a physician is giving the patient the choice by showing actually the 2 available technologies, we also see that spontaneously Genio is winning this.

I think -- and one of the questions that I have personally as well is based off of your presentation, when you mentioned type 2 diabetes being one of the comorbidities or the issues that do come up with it. So then the question then leads to the GLP-1 weight reduction drugs. What role do you think that they play when it comes to sleep apnea? And how do you think about potential near-term and long-term impact of GLP-1s to the specific space?

Yes. So from day 1 at Nyxoah, we have been saying that we welcome GLP-1 to our space for the simple reason that it will further expand the eligible to treat number of patients. And why is this? If you look at clinical evidence for hypoglossal nerve stimulation, we see that we are extremely efficient or if he has -- when the BMI is limited up to 32. That's where all the clinical evidence is taking place.

Now with GLP-1s, we are going to the extreme obese patients with BMI of 35 all the way up to 40. Those patients, we would never be able to treat until GLP-1s came in play. So what we are seeing is that by losing weight, there is also a direct correlation on the severity of OSA, but we are seeing that the new patients coming in with a BMI up to 32 are still in need for treatment. And that's a complete new cohort that we would never be able to touch if there would not have been GLP-1s. So there is -- I think there is a short-term, midterm and long-term positive effect on GLP-1s.

Perfect. I'll just quickly check in the room if there are any questions in person. Otherwise, we can continue with the online questions. Perfect. So the next question that we have online is regarding reimbursement, are you still tracking to 100% prior authorized approvals? And how quickly is the prior authorization process going?

Yes. So I think it was one of the most heated topics during JPMorgan when it came to HGNS. I can confirm what we also were saying in the beginning. We started building our reimbursement strategy already in '24. We followed the correct traditional path working with the medical association, AAO. Then there was a recommendation made by AMA to CMS. CMS accepted coverage. Today, we are in policy for this. And so far, we have seen both with private payers as with CMS, a 100% exception.

So for us, the way we are doing this with private payers, we work with preauthorizations. With CMS and with local MACs, we work with manual reviews, which is a little bit comparable to preauthorizations. And we have seen no change, in fact, in how we ended the year in the month of October, November, December. So for us, so far, so good.

Next question is, when do you expect FDA approval for the complete concentric collapse indication?

Yes. So first of all, we need to have 12-month data. These data we will have available in June. Based on this, it will take a little time to analyze this and to put it in the correct format to submit to FDA for a supplement and for a label expansion. We do think that end of Q4, but most likely beginning Q1 in '27, we will have this on label as well.

And how should investors look at the rest of the Nyxoah pipeline?

Yes. So as I was mentioning, we have a scalable technology platform, and we do put the patient first. So in going forward, we are coming with our second generation of wearable component. What does it mean concretely? It means that we are adding features to the -- to the smart wearable component in order to even capturing more live data.

Next, we're also investing in increasing our gross margins by having a new -- how do you say this, a new adhesive where the disposal or where the smart wearable will be connected to, that will have a direct positive impact on gross margins. So that's what investors can expect in 2026, also into 2027. And then more on the longer run, of course, we are further exploring how we can make our system even more intelligent, how can we integrate AI, for example, in capturing data, eventually resulting in a complete smart system that knows when to activate, knows what waveforms to use when and also maintaining, protecting patients really in function of their specific needs.

And do you have any update on the Ansa Cervicalis pipeline initiative? And where does the program stand today?

I mean with the Ansa Cervicalis, and I do realize that we are an early stage company, but we already looked at the future from day 1. So it's a collaboration that we have with the Vanderbilt University in the U.S. And in fact, what we try to do is we try to understand what it would -- what would happen if you stimulate the hypoglossal nerve and then you start adding on a second of a new nerve being the Ansa in order how this could help patients because there are still roughly 15% of patients that are nonresponders today, how we could help them as well and further expand the total eligible to treat patient population.

And I think this is the last question that we've got online is with the majority focus, and this was the prior slide as well on the U.S., what about your international business? And what are the key drivers for international growth that you see in the next 1 year?

Yes. So I think you pointed out correctly. As a company of our stage, we need to make strategic choices. And of course, the focus is the U.S. for a simple reason that it's a huge market, 97% of currently HGNS treatment or revenue is generated in the U.S., and we want to have a piece of this.

Next, internationally, besides Europe, we also entered the UAE. So we will be very selective. We will not go everywhere. But where we go, we need to fulfill a couple of criteria. First, it is obtaining reimbursement. Second one, having enthusiastic surgeons that we can train and also having the correct patients identified so that we can guarantee high-quality implants resulting also in high-quality patient outcomes.

Perfect. And with that, thank you so much, Olivier. Thank you for your time.

Thank you. Thank you for having me.

Good day, and thank you for standing by. Welcome to the Nyxoah Third Quarter 2025 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to turn the call over to your speaker today, Pearson Dennis. Please go ahead.

Thank you. Good afternoon, everyone, and I welcome you to our third quarter 2025 earnings call.

Participating from the company today will be Olivier Taelman, Chief Executive Officer; and John Landry, Chief Financial Officer.

During the call, we will discuss our operating activities and review our third quarter 2025 financial results released after U.S. market closing today, after which we will host a question-and-answer session. The press release can be found on the Investor Relations section of our website. This call is being recorded and will be archived in the Events section on the Investor Relations tab of our website.

Before we begin, I'd like to remind you that any statements that relate to expectations or predictions of future events, market trends, results or performance are forward-looking statements. All forward-looking statements are based upon our current estimates and various assumptions. These forward-looking statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. All forward-looking statements are based upon current available information, and the company assumes no obligation to update these statements.

Accordingly, you should not place undue reliance on these forward-looking statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 20-F filed with the Securities and Exchange Commission on March 20, 2025.

With that, I will now turn the call over to Olivier.

Thank you, Pearson. Good day, everyone, and thank you for joining us for the third quarter 2025 earnings call. Since FDA approval on August 8, our U.S. launch activities following FDA approval of Genio have generated strong enthusiasm across the ENT and sleep communities. Physicians welcome the long-awaited optionality now available to their OSA patients and the end of a single solution market. During the recent International Surgical Sleep Society, ISSS meeting, our Genio Symposium and educational event drew a full room of clinicians eager to engage with real-world case discussions and share perspectives.

These discussions reflected what we continue to observe globally. Clinicians value choice in treating Obstructive Sleep Apnea and our differentiated bilateral patient-centric design resonates strongly with both surgeons and sleep physicians. We were particularly encouraged by conversations with physicians familiar with Genio's clinical performance in Europe as well as the strong clinician results demonstrated in the DREAM study. Many providers highlighted the opportunity to tailor treatment based on individual patient needs and expressed appreciation for our approach to chronic disease management, patient feedback integration and multidisciplinary care pathways.

Finally, our first commercial Genio implant in the U.S. completed as early as September represented an important milestone for our teams and partners, already generating [ USD 231,000 ] in revenue during the third quarter and ahead of our expectations. Early surgeon feedback has emphasized streamlined patient management, close collaboration between ENTs and sleep physicians and strong patient follow-up engagement. While still early, this reinforces our confidence that Genio is well positioned to serve U.S. OSA patients with a compelling new alternative.

We are navigating the critical steps of early commercialization and the momentum we are generating in training physicians, obtaining value analysis committee approvals and securing coverage from major public and private payers is extremely encouraging. In our initial launch strategy with 25 territory managers, we are focused on the initial 125 of the top 400 high-volume hypoglossal nerve sites, representing roughly 75% to 80% of the total HGNS volume.

We are actively tracking a number of leading indicators to measure our early progress. Since launch until end of October, we can report that out of the 125 targeted accounts, 111 surgeons have already successfully been trained on Genio. Second leading indicator, 102 value analysis committee submissions have been completed, of which already 35 approvals have been received.

Reimbursement has been secured with Medicare and 10 private payers already, including UnitedHealthcare, Blue Cross Blue Shield and Cigna. 63 prior authorizations were submitted, 21 approvals have been already received with a 100% success ratio. In all of these approvals, the CPT Code 64568 was accepted. 15 implants were already successfully performed across 9 accounts in the first 12 weeks. Beginning on the road since the launch and interacting with surgeons, I've been incredibly encouraged by feedback I'm hearing. Surgeons are enthusiastic to finally have second HGNS option to offer to their OSA patients.

They commented that Genio is unique and differentiated as a solution, which resonates very well with patients seeking therapy. They highlight the powerful and symmetric tongue protrusion achieved with bilateral stimulation. They report that the Genio procedure is efficient with procedure times up to 60 minutes on average.

In conclusion, first interaction with Genio was positive. Surgeons are excited to incorporate the Genio solution into their daily practice. On the reimbursement side, we have made significant progress. Our Genio Access Program provides dedicated support to our customers for prior authorizations. Each territory manager works with a dedicated case manager who interfaces between the clinical team, patient and sales team. The program includes a reimbursement outline and communication portal for real-time tracking. To date, we have achieved 100% approval on all our prior authorization submissions through our Genio Access Program, including with 10 key private payers such as UnitedHealthcare, Blue Cross Blue Shield, Health Care Service Corporation, Anthem and Cigna.

In addition to providing this direct support to our customers, we are also seeing progress with commercial payer policy decisions. Health Care Service Corporation or HCSC operates Blue Cross Blue Shield plans in Illinois, Texas, Oklahoma, New Mexico and Montana. HCSC and Blue Cross Blue Shield of Michigan has updated the hypoglossal nerve stimulation medical policies to already include CPT Code 64568 as a reference procedure code. While coverage of hypoglossal nerve stimulation was already established, the inclusion of this code provides additional clarity for providers and payers, which the company expects will help reduce administrative barriers and streamline patient access. HCSC and BCBS of Michigan represent over 26 million members across 6 states. We continue engaging with additional commercial payers and expect continued progress on coverage decisions in the coming call -- in the coming quarters.

Looking ahead, our priorities are clear. We will continue expanding our U.S. commercial organization, adding territory managers to deepen coverage of high-volume implanting centers. Training programs are scheduled through year-end with a strong pipeline of surgeons requesting implant slots. Beyond the U.S., we are focused on driving deeper penetration in Germany and in the United Kingdom, where we maintain a strong presence. And in the Middle East, where we owe exclusive status as the only available HGNS solution while selectively expanding into additional geographies with strong demand for differentiated technology. This is an exciting time for Nyxoah. We have the team in place, we have surgeon demand, we have payer coverage and most importantly, we have patients choosing Genio. In the fourth quarter, we are focused on execution, training more surgeons, activating more accounts and treating more patients.

With that, I will now turn the call over to our CFO, John Landry, for a financial update.

Thank you, Olivier. We recorded revenue of EUR 2 million in the third quarter of 2025 compared to EUR 1.3 million in the third quarter of 2024, an increase of 56%. Gross margin in the third quarter of 2025 was 60.5% compared to 62% in the third quarter of 2024. Total operating loss for the third quarter of 2025 was EUR 24.4 million versus EUR 15 million in the third quarter of 2024. This was driven by the acceleration in the company's commercial investments in the U.S. in preparation for post-FDA commercial launch.

Our cash position, including cash, cash equivalents and financial assets was EUR 22.5 million at September 30, 2025, compared to EUR 43 million at June 30, 2025. I'm excited to share, as we announced earlier today, that we secured up to $77 million of capital to bolster our balance sheet and help drive the commercialization of Genio in the U.S. This financing includes a private placement of equity of approximately $25 million, which included existing strategic investors, Cochlear and ResMed as well as our Chairman and management team members. It also includes a convertible bond, which can provide us with up to $52 million in 2 tranches with the first tranche of $26 million available upon closing of the convertible note.

The second equally sized tranche can be drawn down at the company's discretion for the 30 days, starting 7 months after the closing of the transaction. We believe the proceeds of this transaction in conjunction with currently available capital provides us with cash runway into the first quarter of 2027. For the fourth quarter of 2025, we expect global revenue to be between EUR 3.4 million and EUR 3.6 million.

With that, I'll now turn it back over to Olivier for some closing remarks.

Thank you, John. As we close, I want to remind everyone what truly defines Nyxoah. The future of sleep medicine will be defined by those companies who understand and continuously learn for their patients. With Genio, we are not treating sleep apnea as a onetime event. We are managing a chronic condition. Our system learns from every breath every night, turning data into insights and insights into better outcomes. We will be integrating the power of AI and self-learning in our next generation of Genio, developing a therapy that adapts, evolves and becomes more personal over time. It's not just about features of a device, it's about creating an ecosystem that empowers patients, physicians and health care payers to manage sleep apnea smarter, simpler and more sustainable.

At Nyxoah, everything we do starts and ends with the patient, and we will continue to empower them to effectively manage their OSA through our technology. We believe that our focus on innovation, supported by clinical evidence drives progress and that the winners will be the patients who finally get their night back through good sleep quality. And at Nyxoah, we are excited that we can finally offer this to patients in the United States.

With that, I would now like to open the lines for Q&A.

[Operator Instructions] Our first question comes from Ross Osborn with Cantor Fitzgerald.

Congrats on the progress. Excited to see the U.S. launch going well right off the bat. So maybe starting off and more on the qualitative side, could you provide some feedback that you're hearing from docs as well as their patients on why they're choosing Genio versus other options?

Definitely, Ross, thank you for the question. So first of all, as I was mentioning, physicians are extremely excited that they have optionality so that today, they can offer their patients the Genio solution as well, and this is resonating extremely strong. Second thing that we are hearing as well that is always coming out is the fact that we offer a bilateral stimulation solution that is really expecting the anatomy of the hypoglossal nerve and that is also resulting in an option to treat patients also with more complex airway obstructions. So those are the 2 main things that keep coming back and that you are hearing first.

Okay. Great. And then lastly, and apologies if I missed this, where do you stand on your sales force build-out?

So as I was already earlier communicating, so we do a focused launch on the top 400 implant accounts in the U.S., so the high-volume HGNS sites. With our current sales force, we are covering the first 125 out of these 400. We will further scale by adding every quarter up to 15 territory managers that would represent them another 75 implant sites. So if you do a little bit calculation behind after [ 4 quarters ], we would be able to cover all of these 400 high-volume implant sites. Speed a little bit further, and we will end up with a sales force of 85 people.

[Operator Instructions] Our next question comes from Adam Maeder with Piper Sandler.

Congrats on U.S. launch. A couple for me, if that's okay. And maybe just to start, Olivier, I think I had a bad connection. So I just wanted to double check the number of implants that were done in the U.S. in Q3. Can you just give us that number again as well as the U.S. revenue in Q3?

Yes, definitely. So we did 15 implants spread over 9 different accounts, and they were all done in the month of September. And we did [ EUR 231,000 ] in revenue.

Just to be clear, Adam, that 15 was through the end of October. Sorry about that. 15 was through the end of October. And the [ EUR 231,000 ] was through the end of September for euro-denominated revenue.

I got it. Okay. And then I guess just kind of a related question. But as we think about models for Q4 and U.S. launch, I appreciate, John, you gave us EUR 3.4 million to EUR 3.6 million outlook for the overall business. Any finer point you want to put on U.S. versus OUS at this point?

Yes. I appreciate the question, Adam. At this point, we're not going to break out the U.S. versus international in terms of guidance. We're still in the early phases here of the account activation ramp in the U.S. And that Q4 guidance really reflects the continued acceleration of U.S. implants as more accounts complete VAC approvals and prior authorizations, more surgeons are trained and we also see sustained growth in both Germany and the U.K.

Okay. Understood. And just one last one, if I may. Olivier, if I heard correctly, did you say the device is going to become potentially more proximal over time? Did I catch that remark correctly? And if so, maybe just walk us through the appeal of going proximal versus distal?

Adam, I think you must have misheard it because I never talked about proximal versus going more distal when it comes to the use of our device. So I want to be very specific on this. We have a specific positioning where we place the [ pedals ] on the nerve, and that is also very well adapted, if I can refer to this. So it's very clear that there are no changes at all that we are making. So maybe what you heard was when we were talking about the next generation that we are developing of product where, of course, we keep putting the patient at the center and then we are talking about integrating self-learning into our device becoming smarter and more autonomous, so that patients also can get more control about their technology.

[Operator Instructions] Our next question comes from Suraj Kalia with Oppenheimer.

Olivier, John, can you hear me all right?

Yes. Nice to hear you, Suraj.

Perfect. Olivier, I'll ask both my questions together and pardon the background noise. I'm in the airport. So Olivier, of the current implants, admittedly, they are very -- relatively a smaller quantity, right? Can you give us an idea of where the initial appeal is? Is it women? Is it CCC? Is the lack of IPG target? Is it supine, non-supine? Again, with this initial cohort of implants, have you all seen any pull-through specifically in one category?

And if I could just also lump in my second question quickly, Olivier, of the 100-plus sites that you are targeting, I appreciate you walking us through in terms of CPT codes and whatnot that are getting through prior auth. Olivier, how is Genio being slotted from a logistical perspective? Because most sites of these high-volume sites have these "Inspire Days", right? And obviously, the push is on to ramp up Inspire V and put more. And is Genio slotted on Inspire Days? Or are you all seeing it separate at least from a logistical perspective? Congrats on the progress.

I will try to answer as completely as I can, Suraj, because it was quite a long question, and to your point, the sound quality wasn't as good as I would hope it to be. So first of all, I do want to emphasize how with Genio, we are totally differentiated from a pacemaker platform technology. And this is also determining the choice of physicians. So I think the first part of the question was why Genio and who is using Genio and what is about female, male and further differentiation. I do think that it's clear what we are seeing is that it's a real combination of male and female. So it's not that our technology is only [ revolved ] to treat one or the other. It's clear that it applies and appeals very well with both male and female.

What we're also seeing is that the average age is quite young. I mean, young defined as 52 to 54 years old and also people who are really consciously working with their health in the sense that they do value the power of not needing resurgery when a battery is depleted, not needing resurgery to benefit from the latest integrated software upgrades. And they embrace also the implant for life concept, knowing that once an implant is done, they are protected regardless of what sleep position they are, they are protected regardless if the airway obstruction is a little bit more complex. So this I would like to point out.

Second, I was hearing also the CCC aspect in your question. It is clear that in our label, CCC is not a contraindication. It's under the warning, but it's also not yet on label because that's where we are waiting for the ACCCESS study data outcome where we closed enrollment and what we expect to show next year around this period because we need to do a 12-month follow-up. So CCC is not contraindicated. It's under the warning and it can be chosen for a physician at physician discretion, but it's not on label. So I want to be very clear on this.

And then last, when we also talk about Genio and compared to also the logistics in the hospitals. So once we are working through the VAC committee, it's clear that we see that in the high-volume accounts. Of course, we breaking the monopoly that is currently there by giving options of choice. And we're also hearing through market research, a very encouraging sign that physicians are seeing this as becoming a market where it will end up in a 50-50 or even with some maybe playing out in our favor. So a lot of enthusiasm, a clear differentiation versus pacemaker, a clear differentiation in patients choosing the implant for life approach with no need for resurgery going forward and no differentiation between male, female. It's at this moment based on the numbers and the experience we build in the U.S., we see that both are really benefiting and choosing for Genio. I hope that answers your question.

[Operator Instructions] Our next question comes from Jon Block with Stifel.

John, maybe the first one for you. Just to level set, like as we build out and refine our models, are these the KPIs that you're going to be providing on a quarterly sort of consistent basis? In other words, should we be focusing on the number of surgeons trained, the number of accounts that have implanted, the VAC figures? Is that the expectation that these will be the metrics and transparency with it every 3 months or so?

For the short term, Jon, yes. I think over the short term, maybe in the near term, midterm, we'll provide these metrics. As we become a more material revenue generator, we'll probably likely drop one of them, potentially the value analysis committee packages that are submitted. We'll probably do that. We'll obviously continue to provide updates on reimbursement and surgeons trained. But I think the one that over time will probably drop is value analysis committee. So we want to give everybody a sense as to the progress we're making based on these KPIs. And then as we become a revenue generator, we'll evaluate these going forward.

Okay. And the second one is sort of a 2-parter. Maybe the first one, because we were sort of flip-flopping between September and October. So September, John, [ EUR 231,000 ] implies, I don't know, 10 to 11 U.S. implants in the month of September. And then is the number of implants total 15 through October? Do I have that correct?

Yes, 15 implants were done through the end of October. Correct.

Okay. So maybe you just want to talk about why the number of implants sort of get cut in half from September to October. Maybe that's just a stocking dynamic and how they go out to the facilities, but help us out there, please. And Olivier, more of a high-level question for you. I'm just curious, as you take a step back, and obviously, you've been waiting for the U.S. launch for quite some time now. What was the biggest surprise in your view from the U.S. launch over the past couple of months?

Yes. No, thank you, Jon, for the questions. And I think I can handle part 1 and [ part 2 ] because they're a little bit linked to each other. So when you say what was the biggest surprise, I never thought that we would advance so fast from a surgeon training all the way to a surgeon implant and knowing that we -- in between, we had to get the VAC approval and we get to have a preauthorization submission followed by a preauthorization approval by the payer before we could do an implant.

So that was for me a very positive surprise that we can move fast, and we see that we are -- continue moving fast. And then the first part of the question, I think it is related to this. So if you see -- and why didn't we do more implants in this time frame, it has simply to do with the fact that we see on average when there is a preauthorization submitted, it takes like 2 weeks to obtain an approval. Once you have an approval, it takes another 2 weeks before we generate revenue. So in total, we're talking about roughly 4 weeks. So if we then start looking when we did the submissions because they are depending on the VAC committee approvals, that is also the phasing and then that will be answering the question, why not more implants were done yet in the month of September and October.

Although I would like to remind everyone that the sales team is doing extremely great. And if you can say that we already have 9 centers where active implants took place in 7 weeks post approval, I think this is a very encouraging result, and I want to applaud my team for this.

[Operator Instructions] Our final question comes from David Rescott with Baird.

Congrats on the launch. I wanted to follow up on a couple of points you made relative to the Q4 guide. First, on pricing, I believe the math again, based on the 10 to 12 implants or so in the quarter versus the reported U.S. number puts you at that [ $20,000 to $25,000 ] ASP. So just wanted to confirm that, that on a U.S. dollar basis was correct. And when we think about this number for Q4, again, we can see what's been done in October. And so that puts a bigger number in the November, December time frame. So how do we think about that kind of November, December cadence to hit what this implied guide is for Q4, assuming that the step-up is more based on the U.S. number?

Yes. Sure, David. Thank you. Thanks for the question. So from an average selling price perspective, we're right in the ZIP code of [ $25,000 ] from an average selling price for our implants. There's not exactly one-for-one correlation with the revenue that's booked. We have -- as we do in Europe, we defer a small piece of the revenue when we ship because we spread out the disposable shipments over the course of the year. So a portion of it that we spread out over time. So there's that delta.

And then in terms of the guide, we don't necessarily -- we're not breaking out U.S. versus international here for the fourth quarter to get to EUR 3.4 million to EUR 3.6 million. But as we look at our number of cases we've done in October, as we look ahead to where we're going for cases that need to be performed in the months of November and December in order to fulfill that demand for those cases, we would expect our U.S. revenue to grow from October to November and then from November again to December. So that's how we're thinking about it and get the visibility into the number of cases that we expect here in the remaining 60-ish days of the quarter here.

Okay. I guess on more of the P&L side, I think gross margins were in the low 60s this quarter. I'm guessing some of the rollout is impacting that. But maybe can you give us a sense for, into the fourth quarter, into 2026, how we should be thinking about this contribution from the U.S. rollout maybe impacting the gross margin line as you scale up and more broadly roll out?

Sure, absolutely. So as we think about gross margins, long term, we have an opportunity to get our gross margins into the 80% range. And I think it's really a multipoint program to get there. One is we have our next-generation Genio 2.2, which will enhance the patient experience from an activation ship perspective as well as a disposable patch perspective, but also significantly reduce the cost.

So that's more of a tailwind in '26, early '27, but that will be a meaningful step-up in gross margin from there. The other item is in terms of volume, as we scale our production volumes of our implant, we have different volume breakpoints in our contract manufacturing agreement. So as we drive volume, we'll see those continue to reduce over time. And then just overall working through supply chain and logistics as we're in the early stages of that right now. And as those systems mature and we work through the flow of goods throughout the entire supply chain channel, that will help be the final leg of the stool to get us up to that 8-plus percent gross margin range. So in the near term, i.e., fourth quarter this year and '26, probably not many drivers in the way of moving gross margin up from where we are today. I'd expect that more towards tail end of '26 going into '27.

And pardon, this is Kevin, the operator. We did have some just recently queue up. Did you want to go ahead and take that question?

Yes.

[Operator Instructions] Our next question comes from Paige Chamberlain with Wolfe Research.

I just have a couple on reimbursement. I appreciate the updates in the prepared remarks there. I guess ahead, I'm just wondering if you can help us frame how to think about the phasing of unlocking wider spread reimbursement in the U.S. and how that progress should flow into our build of the U.S. commercial ramp? And second question, I'll lump it in here. On a similar note, obviously, there have been some changes and moving parts around coding in the HGNS space, 64568 is the code you guys are using now. I'm wondering if that is still the code that is intended to be used in the long term.

Thank you. And also refreshing hearing a new voice during the analyst call. So thank you for the question on reimbursement. So first of all, to your point, the CPT Code 64568, which is a recognized code by Medicare for OSA indication. It is the same code used currently for HGNS therapy being Genio or being the alternative therapy, and it's providing a clear pathway for reimbursement with both Medicare but also commercial payers. So going forward, we do think that this will be the coding that will be further used. And since we are only launching since August 8, that is also the only code that we are using and have been using because it's the code that fits best also our technology, and we're also now seeing that this is the coding also where the latest innovation is used for HGNS.

So for us, this was a big win because we knew also that this was still a question that could only be answered once you submit a reimbursement file and you also actually receive payment. And it's, of course, very rewarding for us to see that we did not only receive payment through Medicare, but also through private payers, as I was mentioning.

Yes. And I'd really like to point out and recognize our market access team is doing a tremendous amount of work and doing a great job with our Genio Access Program to help work through this initial process. And I think the HCSC and Blue Cross Blue Shield of Michigan, where we have 64568 is a reference procedure code. I think that's just sort of the start of it. I think over time, we'll have more and more of these payers included, including the 64568. It's a reference procedure code, which will help facilitate the process.

I think the thing that's very encouraging to us to see right now is that from a cycle time perspective, from a preauthorization perspective, we're seeing roughly a 2 business week cycle time from the time of submission to approvals. And then on the back end, once the implants are done, we're seeing another 2-week cycle time roughly for the facilities and physicians to get paid. So it's been pretty consistent, and we're really very excited about that and look forward to seeing that continue.

And maybe to close on this one as well if you see and look at the future of [ Nyxoah ] go forward. So sometimes it's nice to be second because there was a lot of work done already, and I think HGNS is already extremely well recognized through payers. So we do not need to do the work on the heavy lifting with every single payer step by step because they are familiar with HGNS and what it can do in the treatment of moderate to severe OSA.

I'm not showing any further questions at this time. I'd like to turn the call back over to Olivier for any further remarks.

I would like to thank everyone for participating. Thank you for the good questions. As I was mentioning before, it's the most exciting time for the company. We have been waiting and working hard to get to FDA approval. We obtained it and our focus is launching, continue launching, opening more sites, treating more patients. And this is, in fact, why we were in this business and what we want to do offer this solution to seriously impact patients' lives. So thank you, and good afternoon, good evening, everyone.

Ladies and gentlemen, this does conclude today's presentation. We thank you for your participation. You may now disconnect, and have a wonderful day.

Excellent. Thank you, everyone, for joining us. Before we begin, I'll give the standard disclosure. For important disclosures, please see the Morgan Stanley research disclosure website at morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative.

With that, thanks, everyone, for joining us. We are here with the CEO of Nyxoah. Thanks for being with us here, Olivier.

Yes. So first of all, thank you for having us and giving us the opportunity to interact and meet with investors, highly appreciate it.

Yes, absolutely. So maybe to kick it off, for those in the audience unfamiliar with Nyxoah, could you please provide a brief overview of how Nyxoah is changing the obstructive sleep apnea landscape?

Yes. No, no, definitely. So with Nyxoah, we are offering an innovative next-generation neuromodulation solution, more specific hypoglossal nerve stimulation to treat moderate-to-severe OSA patients. I do think we can say we have a totally differentiated technology driven by bilateral stimulation, single-incision implant.

Next to the bilateral stimulation and single incision, it's also clear that we go with full body MRI compatibility from the beginning for the simple reason that we do not have an implantable battery. When we look at the wearable component, so the piece that the patient will wear when he's or she is sleeping, the wearable component is containing the battery, but also the software of the system. And one of the big advantages when you do not have an implantable battery is that there is no need for resurgery when the battery is depleted, but there is also no need for resurgery when, for example, we have an upgrade in software that we want to push through that like that your iPhone, we can do this even without seeing the patient in the hospital.

If you combine all of these things, I do think we can conclude that we are very differentiated to what is currently out there, which is a base metric platform technology that we are looking forward to launch in the U.S. as it is happening today.

Yes, absolutely. We'll definitely hit on that. Before we touch on the launch, maybe could you talk a little bit about your DREAM study? You showed some pretty differentiated data. Could you give us the highlights and why they matter so much to patients and physicians?

Yes. So I think it's truly important that you have robust clinical evidence. So when you look at the study protocol of DREAM, so we had a primary endpoint, a reduction of Apnea-Hypopnea Index. So we had to reduce the number of events or obstructions with at least 50%, and we had to bring the overall number of events below 20. So those are the so-called Sher criteria.

Next, there is also the oxygen desaturation expressed in an oxygen desaturation index, where we also had to show a significant relief in the oxygen desaturation index. I'm pleased, first of all, that we met all primary and secondary endpoints. I think that's an important one.

Next, if you drill a little bit deeper and you look also what is important for the patient, but also for the physician and the selection coming from clinical evidence, I think -- and this is also supporting our vision in making sleep simple, a physician, he wants to have a safe product. So from a severe adverse events percentage, we had 8.7%. If you compare and put it a little bit in perspective also towards competition, it was close to 20%. I do think we have a safe product, and it's also driven by the single incision compared to multiple incisions.

If you go a little bit further in the efficacy perspective, there, I think it's important to see that, first, you can reduce, of course, the number of events, but also looking at the median reduction, important for the physician knowing what to expect regardless what the stages of events like if you have someone with extreme severe OSA, 60 events an hour or someone with more moderate OSA, 20 events an hour, what can you expect from a median reduction and there we showed 70%.

More important, we even showed 82% of people that we were able to bring back an AHI below 15%. And 15% is a little bit a magic number because below 15%, you're officially not in need for treatment. Once you go above 15, you become eligible for treatment. So 82% of all our participants, we were able to bring down to below 15, and that is great.

Then another one being ease of use for the physician is positional OSA. Very short, when you go in a supine position of sleeping on your back, the number of AHI can double and it can also -- and it will definitely significantly increase. We are probably the only company with proven clinical evidence that we maintain the same area opening as when you were in a non-supine position. That is also reflected in our label. And I do think for a physician and for the patient, important in their decision-making of what therapy they would like to have.

So those are more or less the big things that are coming out of the study, safe positional OSA, reduction of about 80% below 15%, and we hope that this is resonating well with the clinical audiences.

Yes, absolutely. And I think you mentioned your label. That obviously came fairly recently. We just got approval in the U.S. Can you maybe talk about the specifics of the approval and what it means for patients wanting alternative OSA treatment?

Yes. No, no, definitely. So we got approval on August 8, we'll never forget a Friday. We have been working quite long in order to get the PMA approved, and I'm extremely pleased that the team and the team integrated in achieving this.

Now when we look at our label, we see the position of OSA reflected in the label, but there is also another specific patient population with extremely difficult away openings to treat, and those are the patients suffering from complete concentric collapse.

It's contraindicated for current HGNS technology, but we already were able to show positive data in our Australian study. In Europe, we already had the notified body accepting this and adding to our label. And we see in the U.S. that we did not receive a contraindication. And that's already, I think, an important sign from FDA that they are trusting the data that we showed. And we are specifically also doing a clinical study related on CCC patients in the U.S. where we hope them to be able to further expand our label in the near future.

So those are, I think, 2 major differentiation points when you compare the Genio label compared with competitive labels. Next, what do we expect? I think nobody likes a monopoly to be very straightforward. When we talk to physicians, they like to be given an alternative, patients like to have an option to choose, and we are the ones who are breaking the current monopoly in HGNS. And I think that's very positively perceived because you have patients and it's measured up to 15% saying, I do not want to have a battery in my body. I refused simply to have this.

So far, there was no alternative, no, there is. So I think that's a good thing. We learned, and I think we can maybe talk a little bit more about this later, but also in our German experience that once you break the monopoly of 2 companies talking and positioning their technology in HGNS that you also see the overall therapy penetration increasing. And I think also that is very important.

Yes, absolutely. We'll definitely hit. I think you hit a lot of super interesting points. ACCCESS, we definitely want to talk a bit about that later. I'll definitely ask you about some of the German experience. But maybe now that you have the approval in hand, how are you planning on prosecuting the U.S. launch to make it as impactful as possible?

Yes. So we obtained on a Friday, the approval and on Monday morning, the sales team was launching. I think we took a little bit gamble by hiring already last year December, our commercial team. We currently have 50, 55 people to be precise in the commercial team. We have 25 different territory managers. We focus on high-volume HGNS implanting accounts and then the people are doing great.

We are now more or less 3 weeks after the FDA approval. We already have strong results in our leading indicators, number of surgeons trained, for example. We also went to the value analysis committees already with a high number of sites. We see the first approvals coming in.

Next, we are working with preauthorizations for PI for commercial payers also there, we have close to 20 already after 10 days of launch of preauthorizations that are submitted. We see the positive reactions with surgeons. So there's a lot of positive energy and people are excited.

Great. I think one of the things that we've heard in the way that you've set up your commercial strategy is that you're targeting primarily sleep physicians as opposed to ENTs, which maybe some people would say that should be the target. So why do you think that's the right strategy? Why target the sleep physician?

So first of all, I would like to highlight we have a two-pronged launch strategy where the ENT surgeons are playing an important role. On the other hand, we believe that a sleep provider or sleep physician is really central in the management of the obstructive sleep apnea patients. Very simple. They are the ones identifying in PSGs like how severe is the condition. They are the ones also working with CPAP as gold standard.

But they are also the ones that are seeing CPAP patients coming back saying, I'm looking for an alternative. I don't tolerate my CPAP, I'm about to quit, I want something else. So therefore, I do think it's a role in educating those physicians one on how to position, what is the correct phenotyping for successful Genio treatment.

But also second, and I think this is so crucial, what is their role in patient management post surgery. Because today, sometimes you see that they're a little bit confused, not knowing exactly what to accept and how to -- what to expect, sorry, and how to contribute.

So by educating and training them in how to stimulate patients, how to adapt stimulation, also how to gather data by working, for example, with home sleep test, seeing and evaluating the kind of technology and how well their patients are doing, will give them the option, first of all, to see themselves, what it can do to help also getting better in defining what is the correct and the best patient phenotype, but also to provide us with data that we can learn from and that we can also develop over time health economic data.

So for us, the sleep doctor has a crucial role and a central role in the patient management. The ENT doctor has more of a technical role in doing high-quality implants and making sure that we can do a lot of implants and doesn't need to worry in post-surgery management of patients that this is done by other experts. And that's how we see the future of HGNS significantly increasing.

Fair enough. So I think you said you've had the approval for a couple of weeks now. Pre-approval, we have heard that there is a lot of pent-up enthusiasm for Genio. As you look forward over the coming months, what are some of the key leading indicators you're focused on to sort of measure the enthusiasm translating into commercial success?

Yes. No, no, an excellent question. So first of all, we focused on the high-volume sites. If you look in the U.S., you have roughly 400 implanting sites that are representing around 80% of the total volume. So we want to reach those 400 as soon as possible.

With our current sales force, we can already reach 125. We will be scaling up every quarter. We are adding more sales reps. We were opening more territories. So from a leading indicator perspective, it starts with surgeons trained. Then we have the value analysis committees approving and accepting our technology, and there are the preauthorizations.

And then, of course, we call it a full active site where the surgeon is trained, where the VACs have approved, where we have patients identified. And that's all the leading indicators before we will start generating revenue and also start communicating on and giving projections on revenue and on plan is done.

Right. And I guess you mentioned the 400 high-volume accounts. How are you identifying those? And what would success look like at one of those accounts once you're in?

So how do we identify them and allow me to make a little joke, but sometimes it's nice to be second. I mean we have -- our competitor has done great work in developing and introducing HGNS and getting it covered. And sometimes when you come in as a smart follower, they have paved the way, and it's relatively straightforward to identify those accounts.

But there, you took an advantage. On the other hand, how does success look like? So I think successful in those accounts will be expressed in market share and market share gain. We started in Germany. We did get a commercial proof of concept. We were able to capture 25% market share in 2 years' time.

Not saying we will do the same thing in the U.S., but I do think it is an illustration that there is an acceptance for that there is a need for an alternative, and we hope to see this also in the U.S. So we will be having high-volume accounts and measure of success in revenue and in market share gain.

Fair enough. Maybe pivoting a bit to reimbursement. We know that can be for many medtechs, a hurdle early in their commercial life cycle. How are you managing your reimbursement progress and sort of how do you make sure that patients get the treatment they need?

So what we did is we looked at both the scientific and the medical organization in our case, the American Association of Otolaryngologists, the AAO. We worked very close with them and also educating them on what our technology is doing, listening to demo they are seeing the place. They are interacting with AMA.

So that was one aspect. The second aspect during the FDA process, we were also support of the early payer program that gave us the opportunity to present Genio in front of all the major commercial payers in the U.S., but there was also quite some educational work done. We know that there initially was a CPT code, 64568 that was used by, I will call them name by Inspire. They moved out of this code, but now they are coming back to the same coding because the latest technology innovation.

We just received the news from Medicare that this code is now also officially accepted as an HGNS code. We do the same mechanism of action. We have the same stimulation parameters. So next to the reimbursement, we, Genio will tap out to the same coding. So that will be step one.

With commercial payers, we will use with preauthorizations with the government payers, I can say, Medicare, we know that we already have several MACs that have accepted this coding and we already covered 1/3 of covered lives. So that's, I think, a good start. And the rest we will see when the preauthorizations going back.

Right. And I guess as we look forward, how will you measure success with payers? Is there a certain cadence of covered lives you're looking for? Are there certain milestones that we should be looking out for in terms of reimbursement?

So first of all, every time that we will have a preauthorization submitted and that is approved by a payer, that will help us scaling up, and we can then also start talking about covered lives. Again, also here, I think we can benefit a little bit from being the second mover because there was a lot of work done. And today, it is -- it was a nerve stimulation that has a coach and it's not a specific technology that has one. And that's why we think we will be able to scale up fast.

Yes. Fair enough. Maybe you mentioned Germany as a proof-of-concept market for commercialization. Maybe can you talk a bit about that experience and how you would think that translates to the U.S.? And maybe what parts you don't think are going to translate?

So first of all, I mean, outside of the U.S., Germany is one of the largest markets for hypoglossal nerve stimulation, but it stays underpenetrated and it is an extremely small market compared to the U.S. It was also not so intensively commercialized by competition.

That being said, there are similarities, and it's caused by reimbursement. So the first thing we wanted to prove is can we obtain a similar reimbursement to our competitor. So the answer was yes. We have exactly the same criteria.

Second thing we wanted to show is if we go to high-volume centers, are we able to bring the monopoly to bring the relationship and to gain significant market share. The answer was 25% in 2 years' time. The next thing is how can we drive sleep levels? So also there, we looked at sleep physicians.

We saw that we were struggling a little bit because the sleep physician in Germany is totally not well educated when it comes to HGNS, and they were seeing us as a novel therapy. That's how large the lack of awareness was. So there, we struggled a little bit, and we had to do some more focused DTC reaching out direct to patient organizations.

So the learning was education of sleep physicians, it is crucial. And then last, what we also were seeing in Germany is that the importance of also patient testimonials, people speaking on forums being positive about your technology. And also there, we have positive interactions. So that was the German proof of concept. Next thing since this year, we entered the U.K. market, where both competition and Genio entered at the same time.

I can tell you, there you see that we are so identified who will be the #1. And I think we have a little bit the lead after 6 months. And then last, we also wanted to explore the distribution model. And there, we are unique by entering in the Middle East countries. So we did our first implants in Dubai, in Abu Dhabi and in Kuwait.

And there also, we are learning what it means if we would go indirect. So those are the 3 eye-learning concepts. Germany, closest to the U.S. with differentiation. U.K. [indiscernible] at the same time. We show that we can take leadership. And then in the Middle East, we are the only provider to go indirect and also there we have...

Fair enough. And as you look at your experience in those 3 markets, is there any specific type of patient where you're more successful? Or what is the ideal patient profile that you're looking for that's really successful with Genio?

So it's a very interesting question because when you look at obstructive sleep apnea, the average age is roughly 53, 54 years old. So I hope those people live a little less 30, 40, even longer. So it's becoming almost like a lifestyle implant that we would like to promote in the sense that we have an implant for life, 25 years longevity.

We have a passive implant that is totally, but also the brain is external. So there is no need for resurgery anymore. And we want to also have people that are conscious about their health. I mean, if you have a BMI of 40 and you refuse to lose weight to be very straightforward and you want to not change your lifestyle, I mean, I don't think an implant or a drug will change your life.

There need to be some kind of motivation, especially in sleep. So we want to stay away from those extreme of BMIs above 35. We want to position ourselves for people who are conscious that a healthy lifestyle will also give them, I mean, not only more functionality, but also the aspect of not buying of comorbidities.

I think that is very important. And when you look at the perfect Genio patient, it's a female or a male 53, 54 years old, who are conscious about this and who also want to make an effort to stay healthy for the coming 20, 30, 40 years.

And I guess, in the vein of health, there's obviously a lot more optionality now for people above a certain BMI with therapeutics that might take them below a certain BMI threshold. How are you thinking about the evolving landscape in therapeutics, either expanding your funnel or not expanding your funnel? Or does it change the Nyxoah opportunity?

So the GLP-1 question.

Yes.

So what is the impact on this? So as I was saying, all of clinical evidence is done with the BMI limitation of 32. So that is where we know we can be very efficient and offer safe technology. So if you look at the GLP-1s in the SURMOUNT trial of Eli Lilly, the average BMI was 37.

And we saw clearly that the AHI was also very high, it was 50. So there is a correlation between the weight of the person and obstructive sleep apnea goes without saying. Now these results were showing that when you use a GLP-1 and you are a GLP-1 responder, you can lose up to 25% of your BMI. So the 37% becomes somewhere like back of 20, so 28, 29. The correlation with AHI was patients were losing, in fact, 40% to 60% of events. So 50 becomes somewhere in the 22 all the way to 28.

This is spot in where we have strong clinical evidence where patients are still in need of treatment and where they have demonstrated also their motivation to lose weight. So this assessment, we were unable to tap on if there would not have been GLP-1 because we are limiting ourselves at 32, and we do not want to take the risk to increase our BMI because I do think it will be a strategic mistake already with a young novel technology going to so extreme high BMIs that you could have a failure rate that will be higher, but it's not helping nobody.

So we see this as very positive. Will we lose some patients? Definitely. I call it more the cosmetic use of GLP-1. But if you see net-net, there will be more patients coming in from the extreme obese and high BMIs than patients were going out because of more the cosmetic use of GLP-1.

Yes. Okay. Fair enough. I think one -- maybe going back to a bit of the commercial side of the equation. I think if I'm remembering correctly, you mentioned over 100 trained physicians in your last earnings call. Can you talk a little bit about sort of the cadence of physician training and what the period was to train those 100 physicians and if we should expect 1,000 physicians in the next call if you trained over 2 weeks? Or how should we think about physician training?

So first of all, I would like to complement my training and educational team because they're doing a phenomenal job. Just to highlight how we do this, we [fly] physicians in most of the time on a Thursday, late afternoon. We start with a dinner where we also have discussions on what is the patient's phenotype, how should the perfect patient look like. We bring also sleep physicians in these trainings. So this is already this relationship building between the ENT surgeon and the sleep physician.

We start very early, 6:30 in the morning with a theoretical session. And then after the theoretical session, the surgeons go into the cadaver lab and they start learning how to implant. The sleep physicians, they go with our technical people learning how to program, how to stimulate, how to interact with patients, what to expect from a technology. And then we are all coming together for the light lunch and people are flying back.

The next group is coming in, in the afternoon on Friday. The next group is coming in on the afternoon on Saturday. And each time we have a physician group of roughly 12 physicians because with the cadavers that we are doing, we want to make sure we can guarantee the correct quality and 12 surgeons at a time is perfect, and we have weekend between 24 to 36 surgeons that are trained.

And how many of those trainings do you have to do to feel comfortable that you'll be able to successfully implant on Genio?

After the training, the surgeon is flying back to us of our hospital. They -- before the training, we have identified a number of patients so that they can start also actively implanting. We will send all the process to make sure that the first 2 cases have gone spotless. And what we see in the learning curve is that 4 implants is more or less a magical number that surgeons are feeling really comfortable. So -- and then they're off to a great start.

Right. Great. And is that -- are the 100 physicians, are they -- is it across centers? Is it multiple from a specific center? I know you mentioned there was a target of 25 in the near term. How should we think about either geographically, is there any specific place that you're starting...

So yes, we have a focused launch. So my marketing colleagues, they told me the word heat maps. So heat maps where you have the hotspots a little bit the large implant sites and also where the real network is coming from, we have mapped all this out. To my surprise, you're seeing that the East Coast is much more -- showing much more hotspots to this work compared to the West Coast.

Don't ask me why. And then you see that we have specific regions like, for example, the Texas region, where you have also in the Midwest. So what we are doing is with a focused launch, we have identified several of those hotspots, and that's where we start rolling out our technology.

Great. And how should we think about in those hotspots, are the VAC committees, how is that progress going? How should we think about this?

So I feel like we do in my entire business model. So first, we have the heat maps, you have the hotspots. Then we look at the VAC committee because there is also a huge difference in getting an approval from a VAC and it varies from 1 week to sometimes up to 8 months. So we put a second layer like in these hotspots, which are the ones with the fastest VAC committees. That's where we were Monday, August 11, 12, 13, 14. So that's the first one, resulting in the ones that are already having the approval granted to us, and that's how we will further expand.

Great. Maybe moving a little bit further down the P&L. So you mentioned you had hired the commercial presence back in December. So we should probably have seen some of that already rolling through the P&L. But what should we expect going forward in terms of OpEx, R&D, et cetera? Should we expect OpEx to ramp? How should we think about the cadence of OpEx?

Well, as I mentioned, we will be scaling up our organization, our commercial organization significantly every quarter. So that will definitely have an impact. And I'm looking at our CFO, but I will not be sharing concrete numbers. I don't think this will be wise at this point, but there will be definitely a scaling up when it comes to further building the organization.

Then you touched on something that we did not spoke about, but it's innovation. Although we are a small company, we put innovation as one of the top priorities going forward. in the vision of making sleep simple. I think we can further make progression in our implantable part. But for me, what is so important will be also the patient aspect.

And that part, I named something very simple. I would like to have every patient getting live feedback in the morning when they wake up in how their sleep quality was. We already have a patient app, but we can do much more on this. We can provide information about the ODI. We can provide information about the number of events. So -- and I do think that this will also increase compliance.

It will also make patients like owning their technology. And that's where we are investing in. In our wearable component, we are wearing sensors, for example. Because over time, I would love to have an implant for life that is intelligent that knows automatically when are you sleeping that can also adapt simulation.

And then on the other hand, I want to have a wearable component that is providing data to patients, but also providing data to health care providers and to us to continue self-learning to increase, in fact, the quality of our device. That's where we are investing in. And over time, if I look a little bit further, and I'm thinking 5 years down the road, I want to have a technology with all the wearable component that you don't even see when the patient is implanted.

And there we are thinking about pillow charging concept. So you would have your coil in the pillow, you would have a battery on the night stand and a closed-loop system. This is existing. We just need to roll it out. And here, I'm getting totally carried away and but that is what makes our platform so unique by having a passive implant. We never have to reoperate this patient. we can upgrade all of this without making another incision in the human body. And this is a [indiscernible] technology will never be able or capable to do this. And that's why I think we are in the next-generation hypogoserim, and this will resonate well with patients and with physicians.

Yes. No, absolutely. I did have a question -- actually, my next question was going to be about R&D and about the pipeline opportunities. So you mentioned the pill, you mentioned the intelligent design. How should we think about the cadence? You obviously have a ton of near-term just with the commercial. But as we look further out, 18 months from now, 24, 5 years from now, where -- what's the future hold in terms of next-generation devices?

So with our current technology, I'm convinced we are extremely well positioned to compete with what is existing. So then we will further expand in the CCC patients, representing 30% of the total population. So from an indication perspective.

Now if we go to a product innovation perspective, the implantable component, we are exploring how to stimulate independently. Now we do bilateral, but we can also do this independently. That will help us also treat more complex airways and give the physician more and more leverage.

The next thing that we will do is in the revenue component. So we are -- next generation is ready. It has a different shape. It follows more the shape of the chin, sorry. It contains a sensor. It will further develop the app and provide already and capture more data, as you can expect in roughly 18 months from now, it will be regulatory approved. And then the next step will be that we are going all the way to the and then we will be 23, something like that.

Yes. Wonderful. I think one of the things that you mentioned that I don't want to shortchange is you recently announced the ACES trial has reached a number of patients where you feel comfortable you're going to get good data out of it or a powered study, right? So can you maybe talk about what the ACCESS study will provide, what sort of clinical validation it will provide and what TAM it opens up for you?

Yes. So today, the physicians need to do a specific examination called DISE, drug-induced sleep endoscopy to whether identify if a patient has a complete concentric collapse or not. If they do, they are no longer eligible for what is existing on the market, okay?

So this examination is something that is cumbersome for physicians, but also for patients. And you feel a little bit as we say in Europe, like when you care the endoscopy she in your stat while you're still awake and you're a little bit under, but you are still awake and then they will see what happens with your airway.

This is something nobody likes. So when we designed the ACCCESS trial, we are also very straightforward. If you want to have an on label for CCC, you also need to make sure that the physician and if we go again make sleep simple and a physician can expect the same outcome for a CCC patient as for non-CCC patients. So the primary endpoints are identical as we have in DREAM. So that is one aspect. We had to implant 106 subjects in this study. I will not disclose the precise number, but we have a sustainable number where we believe that we have strong power analytic power to convince that this also should be on label in the U.S.

We have the data from BETTER SLEEP. We have a live experience in Europe. So we do feel comfortable. We also are seeing that FDA currently with other companies that are in the clinical stage are accepting like up to 30% of patients being CCC in a study cohort of roughly 100. We have significantly more patients than 60 to name a number in our ACCCESS study. And we want to bring also CCC patients a solution in SAP in the U.S. So we closed the enrollment. There is a 12-month follow-up that will be us next year around this time. And then we will do a PMA supplement submission, normally 4 to 6 months. So I hope that by the first quarter in '27, we can also have the label expansion in the U.S.

Wonderful. I think we have about a minute left, so I'll ask last question. What do you think is the most underappreciated part of the Nyxoah story that you would want everyone to know?

So I think that people are not fully realizing how differentiated our technology is and how bilateral stimulation will make a difference to maintain also more complex airways open. So that is one aspect. There is one thing I would like to say, and it's may be a funny anecdote in the last minute. But 3 years ago, we made the decision to manufacture in the U.S. for the U.S.

Today, with all the price discussions, it seems to be also a good decision. So I think that's also important. And then we are also having a manufacturing site in Europe for the international market. And I think in the last 30 seconds, the scalability of our platform, as I was already explaining a couple of times, I think this will benefit the patients so much. And I think that's crucial in managing obstructive sleep domain going forward.

Wonderful. Well, we look forward to seeing how you change the landscape of OSA. Thank you. Thank you very much for being here.

Thank you for having us.