Nyxoah Q1 2024 Earnings Report

Nyxoah EPS Results

• Actual EPS: -$0.45
• Consensus EPS: -$0.45
• Beat/Miss: Met Expectations
• One Year Ago EPS: N/A

Nyxoah Revenue Results

• Actual Revenue: $1.33 million
• Expected Revenue: $1.20 million
• Beat/Miss: Beat by +$130.00 thousand
• YoY Revenue Growth: N/A

Nyxoah Announcement Details

• Quarter: Q1 2024
• Date: 5/14/2024
• Time: N/A
• Conference Call Date: Tuesday, May 14, 2024
• Conference Call Time: 4:30PM ET

Nyxoah (NASDAQ:NYXH), headquartered in Mont-Saint-Guibert, Belgium, is a medical technology company focused on neuromodulation therapies for sleep‐disordered breathing. Established in 2018, the company’s primary offering is the Genio® system, a minimally invasive bilateral hypoglossal nerve stimulator designed to treat moderate to severe obstructive sleep apnea (OSA). By electrically stimulating the genioglossus muscle, the device helps maintain airway patency during sleep, reducing apnea events and improving overall sleep quality.

The Genio system comprises a small, implantable stimulator positioned submentally and an external activation unit worn by the patient. Prior to bedtime, users apply the activation patch, which wirelessly powers the implant and delivers timed electrical pulses to the tongue muscles. Following a CE mark in 2019, Nyxoah initiated commercial launches across Europe and select international markets. The company is actively pursuing additional regulatory clearances, including a premarket application with the U.S. Food and Drug Administration, and is conducting ongoing clinical studies to expand the system’s indications and validate long-term safety and efficacy.

Building on its flagship product, Nyxoah continues to invest in research and development aimed at next-generation neuromodulation platforms for various sleep-related disorders. The company maintains a global footprint with commercial operations in Europe and a subsidiary in the United States, and collaborates with leading sleep centers to drive physician adoption and patient access. Nyxoah’s management team combines expertise in medical devices, sleep medicine, and implantable technologies to advance its mission of improving outcomes for patients suffering from obstructive sleep apnea.

Nyxoah Q1 2024 Earnings Call Transcript

Key Takeaways

• The DREAM U.S. Pivotal study met its co-primary endpoints with a 63.5% AHI responder rate and 71.3% ODI responder rate at 12 months, demonstrating a 70.8% median AHI reduction in both supine and non-supine positions.
• The regulatory team is on track to file the 4th and final module of the modular PMA this quarter, aiming for FDA approval by late 2024 or early 2025 and U.S. market entry upon clearance.
• Q1 2024 revenue was €1.2 million, up 177% year-over-year, while operating loss widened to €12.2 million and monthly cash burn of €4.5 million provides a cash runway into late 2024.
• U.S. commercialization plans include building a ~25-person sales team, adding key hires such as the new Chief Medical Officer, and securing payer coverage with prior authorization support for a late-2024 launch.
• European sales nearly tripled in Q1 to €1.2 million, Germany market share rose to 27% in 2023 (50% in Q4), and 51 centers are now trained and implanting the Genio system.

Presentation

[Operator]

Ladies and gentlemen, thank you for standing by. Welcome to Nyxoah First Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a Q&A session. To ask a question during the session, you would need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference call is being recorded. I would now like to turn the conference over to Mikaela Kirkwood, Investor Relations and Communications Manager. Please go ahead.

[Mickaela Kirkwood, Investor Relations and Communications Manager at Nyxoah]

Good afternoon and good evening, everyone, and welcome to our earnings call for the first quarter of 2024. I am Mikaela Kirkwood, Investor Relations and Communications Manager at Nyxoah. Participating from the company today will be Olivier Taelman, Chief Executive Officer, and Loïc Moreau, Chief Financial Officer. During the call, we will discuss our operating activities and review our first quarter financial results released after U.S. markets close today, after which we will host a Q&A 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 of the Investor Relations tab of our website. Before we begin, I would 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.

[Mickaela Kirkwood, Investor Relations and Communications Manager at Nyxoah]

All forward-looking statements are based upon our current estimates and various assumptions. These 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 statements. For a detailed 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 20th, 2024. With that, I will now turn the call over to Olivier.

[Olivier Taelman, CEO at Nyxoah]

Thank you, Mikaela. Good afternoon and good evening, everyone, and thank you for joining us for our first quarter 2024 earnings call. 2024 has been transformational for Nyxoah. In March, we announced our DREAM U.S. Pivotal Study achieved its primary endpoints and demonstrated that Genio has the potential for best-in-class outcomes for OSA patients. I would like to congratulate our clinical team on these terrific results. Our regulatory team is working diligently to file the fourth and final module in our modular PMA submission this quarter, which will set the stage for entering the U.S. market upon FDA approval as early as the end of 2024. Additionally, Dr.

[Olivier Taelman, CEO at Nyxoah]

Maurits Boone, one of the pioneers in hypoglossal nerve stimulation, joined us from Thomas Jefferson University as Chief Medical Officer, and we announced a partnership with the American Association of Otolaryngology–Head and Neck Surgery Foundation to drive Medicare and commercial payer coverage. Commercially, we reported first quarter sales of EUR 1.2 million, almost tripling revenue from the first quarter of 2023 and benefiting from our focused approach on strengthening collaboration between implant surgeons and referring sleep physicians. To recap DREAM, the study had co-primary endpoints of AHI responder rate per the shared criteria at 12 months and ODI responder rate at 12 months. At baseline, subjects had a mean AHI of 28.0, ODI of 27.0, and a body mass index of 28.5.

[Olivier Taelman, CEO at Nyxoah]

On an intent-to-treat or ITT basis, DREAM study showed an AHI responder rate of 63.5% with a p-value of 0.002 and an ODI responder rate of 71.3% with a p-value less than 0.001. With these strong results, the DREAM study met its primary endpoints. Additionally, subjects demonstrated a median 12-month AHI reduction of 70.8% with similar AHI improvements in supine and non-supine sleeping positions. The safety results were favorable, with 11 serious adverse events or SAEs in 10 subjects resulting in an SAE rate of 8.7%. Out of the 11 SAEs, three were device-related, and there were three explants. The DREAM results further differentiate Genio as it was the first HGNS study to require patients to sleep at least 60 minutes in the supine position and demonstrated strong efficacy with patients sleeping supine and non-supine.

[Olivier Taelman, CEO at Nyxoah]

This is of particular importance since published data show increased OSA severity in the supine position, with AHI doubling in the supine versus the lateral position. On average, people sleep 35%-40% in a supine position during a standard night, which was in line with our PSG findings in DREAM. This means that irrespective of a patient's sleeping position, Genio maintains its efficacy. Based on early feedback from the physicians, this can be very impactful on therapy selection. It supports our mission to make sleep simple again, and we intend to apply for the inclusion of supine efficacy results in our label. With the positive DREAM results, we are now finalizing our modular PMA submission. We have responded to the FDA questions on the first three modules and are in an interactive review and anticipate filing the fourth and final module this quarter.

[Olivier Taelman, CEO at Nyxoah]

We are preparing for a launch by the end of 2024 as based upon modular PMA review cycle times. We anticipate FDA approval in late 2024 or early 2025 as we do not control FDA timelines. In parallel, we continue making progress on the reimbursement side as we are establishing reimbursement pathways with commercial payers, Medicare, and Medicaid. The reimbursement team is working closely with the AAO and reimbursement experts to secure coverage at FDA approval. Ahead of approval, we will be conducting a payer feedback interview with the former CMS and commercial plan medical director as well as participate in the early payer feedback program for the FDA, designed to provide direct feedback from major payers such as UnitedHealthcare, Blue Cross Blue Shield, Aetna, as well as CMS. Upon commercialization, we will have a prior authorization team in place to assist with claims submission and payment. Our U.S.

[Olivier Taelman, CEO at Nyxoah]

Focus is significantly increasing, highlighted by the recent addition of Dr. Maurits Boone as Chief Medical Officer. Dr. Boone, who joined Nyxoah from Thomas Jefferson University, is internationally recognized as one of the most experienced surgeons in the field of OSA and HGNS. Being able to have such high-caliber talent joining Nyxoah is a strong validation of the opportunity for Genio to disrupt the OSA market. We are actively building our U.S. commercialization team to be ready to launch by the end of this year. The current HGNS market in the U.S. is very concentrated, allowing for a laser-focused launch, breaking the current monopoly with ENT sites while establishing a patient referral pathway from sleep specialists. As part of the FDA approval process, we ran a usability study with 31 physicians that are the top HGNS implanters in the U.S., and their feedback was overwhelmingly positive.

[Olivier Taelman, CEO at Nyxoah]

Providing a little more color on the usability study, naive surgeons, meaning surgeons without experience with Genio, were invited to participate in a training session on how to safely use the device. The training contained a theoretical session followed by both animal and cadaver implants. 12 hours later, mimicking a real OR setting, surgeons had to repeat the implant without guidance to demonstrate they properly retained the knowledge on device programming and acquired the implantation technique, always ensuring patient safety and comfort during the procedure. These surgeons were adamant they want to be the first Genio implanters in their areas and convinced of the differentiation of Genio versus current HGNS technology in terms of invasiveness, patient centricity, safety, and the simplicity to treat OSA patients regardless of their sleeping position. In addition, a recent independent survey demonstrated that over 20% of U.S.

[Olivier Taelman, CEO at Nyxoah]

HGNS candidates are declining a pacemaker-based platform technology due to their concerns over the invasiveness and having implantable battery in the chest. Going back to Europe, first quarter sales was EUR 1.2 million, an increase of 177% of the first quarter of 2023. As part of our commercialization or commercial proof of concept in Germany, we see that, first, the majority of accounts became mixed implanting accounts embracing Genio in their practice. Second, therapy penetration is strongly accelerating as a result of Genio entering the market as a new player.

[Olivier Taelman, CEO at Nyxoah]

And third, there is a large pool of CPAP quitting patients in need for treatment, which can be addressed through establishing a strong collaboration between implanting surgeons and referral sleep physicians, highlighted by our ResMed collaboration. In summary, we started 2024 strongly by reporting positive DREAM data, further differentiating Genio with our unique supine data. For the remainder of the year, we are working towards FDA approval by the end of the year and commercial readiness for a strong U.S. launch in 2025. With that, I'm pleased to turn the call over to our CFO, Loïc Moreau, who will provide a financial update.

[Loïc Moreau, CFO at Nyxoah]

Thank you, Olivier. Good day to everyone, and thank you for joining us today. Revenue for the first quarter ended March 31, 2024, was EUR 1.2 million, a 177% increase over the first quarter of 2023. Total operating loss for the first quarter was EUR 12.2 million versus EUR 11.4 million in the first quarter of 2023, driven by an acceleration in commercial investments in the U.S. as well as in Europe. As of March 31, 2024, cash and financial assets totaled EUR 44.3 million compared to EUR 57.7 million on December 31, 2023. During the first quarter, our monthly cash burn was EUR 4.5 million. Based on our current cash position, we have a runway into late 2024, which includes the building of the U.S. commercial team. This concludes the formal part of our presentation. Operator, I will turn the call over to you to begin our Q&A session.

[Operator]

Thank you. As a reminder, to ask a question, please press star. Excuse me. Please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. The first question comes from Jon Block with Stifel. Your line is now open.

[Jon Block, Managing Director at Stifel]

Thanks. Good afternoon. First question, Olivier, just any details on where market share stood out in 2023 for Genio in Germany and your thoughts on 2024. And then part two of that first question would just be the burn rate that we can expect as you ramp up the commercialization efforts in the coming months, I think headcount and prepping for launch, as you mentioned, by potentially the end of this year, fourth quarter of 2024. And then I'll ask my follow-up. Thanks, guys.

[Olivier Taelman, CEO at Nyxoah]

Thank you. So, John, first of all, thank you for the questions. Looking back at 2023 and the annual market share, we ended up with 27% overall market share, and we had a very strong Q4 close in 2023, bringing the market share close to 50%. That was, I think, the first part of your question. The second part was.

[Loïc Moreau, CFO at Nyxoah]

Just how we should view whether you want to do monthly burn or quarterly burn as you ramp up some of the commercialization efforts to prepare by launch by the end of this year.

[Olivier Taelman, CEO at Nyxoah]

We burned EUR 4.5 million in Q1. We expect the burn rate to remain steady for the first half of the year and then begin to ramp up in the second half as we accelerate investments in the U.S. commercial organization. As we said, we have cash until late 2024, and that includes the build of the U.S. commercial team.

[Jon Block, Managing Director at Stifel]

Okay. Got that. And if I have any additional questions there, I'll clarify offline. I think just to pivot for the second question, post the release of the DREAM topline data, we performed checks among 30 physicians and asked them how they view the DREAM data relative to Inspire STAR. And I'd sort of categorize the findings as upbeat. The majority viewed DREAM as equivalent to STAR. There was about 20% saying superior and about 17% saying inferior. So painting it with a broad brush, largely equivalent. Here we are, just almost 2 months removed from the topline data being released, Olivier. And I'm curious if maybe you can talk about what you've heard or others at Nyxoah have heard from the docs and maybe the reaction in the marketplace to the data. That'd be very helpful.

[Olivier Taelman, CEO at Nyxoah]

Yep. No, no, definitely, John. And also, thank you for the work that you did on gathering this data. Now, let me, first of all, remind you that the study was not designed for a head-to-head comparison. There are a few different characteristics making DREAM more challenging than STAR. To name the most important one is having minimum 60 minutes supine sleep for all our patients in order to qualify as a responder. And there is also the broader AHI range where in DREAM, you have a range between 15-65, where in STAR, the range was 20-50. Now, that being said, of course, I fully understand the nature of the question. I also fully understand why physicians and other people are looking at how to compare these data.

[Olivier Taelman, CEO at Nyxoah]

So our AHI and ODI response rates are in line with our competitor's STAR study, calculated on a 10-to-3 basis, and our median AHI reduction is even slightly higher. In general, as physicians are well aware of, it's harder to control OSA when patients are supine compared to non-supine because it's more difficult to maintain an open airway in a supine position, mainly driven by gravity. While we plan to hold the data for publication, I can already comment that Genio showed similar AHI reductions in both supine and non-supine positions, while requiring patients to sleep supine may make DREAM more challenging. The data provides evidence that Genio will be able to control patients' OSA regardless of their sleeping position. And I do think, and this is also the feedback that we are getting when we are talking more in-depth with physicians and also know that we have Dr.

[Olivier Taelman, CEO at Nyxoah]

Boone on board explaining it even better than I can to other physicians, we see that this is really perceived as a really, really differentiating factor, making the choice for a physician simpler because they do not need to worry whether a patient is sleeping supine or non-supine, knowing that in data, 35%-40% of a normal standard night, people are sleeping on their back. So I do think that the supine data aspect is really differentiating Genio from STAR, and it's also differentiating and showing a stronger efficacy in the specific supine position, which we like to say and claim that this is showing a superiority compared to what was demonstrated in the STAR trial.

[Jon Block, Managing Director at Stifel]

Very helpful. Thanks, guys.

[Operator]

One moment for the next question. The next question comes from Suraj Kalia with Oppenheimer. Your line is open.

[Suraj Kalia, Managing Director at Oppenheimer]

Good afternoon, Olivier. Loïc, can you hear me all right?

[Loïc Moreau, CFO at Nyxoah]

Yes, we can. Hello.

[Suraj Kalia, Managing Director at Oppenheimer]

So, Olivier, congrats on all the progress. Olivier, just piggybacking on your comments about supine, right? Obviously, that piqued everyone's curiosity. And my first question is a multi-part question, if I could. How is the debate on hypoglossal nerve stim efficacy, supine, non-supine, how is it growing in the field? And also recently, there was an Inspire paper that was talking about decreased efficacy in supine position.

[Olivier Taelman, CEO at Nyxoah]

Yes.

[Suraj Kalia, Managing Director at Oppenheimer]

More so, Olivier, forgive me. Olivier, if you look at one of the arguments made is, "Well, the titration is done in supine position," so this whole debate becomes moot. I'd love to have your take on this. When is the titration really done? Is it supine, non-supine? If you could shed some color there and also the implications for a label if really the titration is done in a supine position. Sorry, it was a multi-part question. Hopefully, you got the gist of it.

[Olivier Taelman, CEO at Nyxoah]

I hope it will be very complete in my honour, Suraj, but let me start with the first part. So yes, this supine versus non-supine is also triggering a lot of further discussion within the ENT sleep surgeons community for the simple reason that when surgeons are deciding to choose for a therapy, it's really important that they try to keep it as simple as possible. And knowing that you have the same OSA or the same airway opening in both supine and non-supine position is definitely an advantage. So that being said, if we look at published data showing that 35%-40% of the time, people are sleeping in a supine position, you understand why this is becoming extremely important.

[Olivier Taelman, CEO at Nyxoah]

On top, we also know that when a patient moves and turns into a supine position, that AHI is twice as high when they are supine versus when they are non-supine. There are even patients who are not suffering from moderate or severe OSA when they are non-supine and become severe OSA patients once they turn supine. So again, an illustration how important it is to have a technology that can guarantee that the airway is opening or stays open during a supine sleep position. Now, at this moment, DREAM is the only study to require patients to sleep minimum 60 minutes supine at a 12-month follow-up visit. And this result showed similar AHI reductions compared to STAR. However, for Genio, it did not matter whether patients were sleeping supine or non-supine.

[Olivier Taelman, CEO at Nyxoah]

STAR did not have a requirement to sleep supine at a 12-month visit and has not presented any data on supine efficacy from the study in the STAR trial. That brings me to your next question. Recently, there was a publication done by Inspire on supine data. We have disclosed in DREAM that our median AHI reduction in supine and non-supine sleeping positions was similar, implying around 70% in supine. If you compare the 70% that we showed to the 51% supine median AHI reduction reported in the recent publication, based on this, I hope you agree with me that I can conclude that Genio has a superior outcome in a supine position. Was I complete in my explanation, or am I missing still something?

[Suraj Kalia, Managing Director at Oppenheimer]

No, sorry. It was a multi-part. I mean, the titration part, Olivier, one of the arguments is, well, the titration for hypoglossal nerve stim is done essentially in supine position. So it should not matter, the supine, non-supine. In all honesty, I never thought about at what point is the titration done? And I'd love to get some clarity on how is titration done for Genio?

[Olivier Taelman, CEO at Nyxoah]

Yes. Now, let me start by first commenting on the fact that titration is done in a supine position. So this is not the case for Genio. But if we just stay on the topic that titration is done for a supine position, it would also imply that there is an over-titration in a non-supine position. And we all know how sensitive patients can be for stimulation. The last thing we want to do is wake them up. So I do think it's important that a patient will get the adequate stimulation.

[Olivier Taelman, CEO at Nyxoah]

And therefore, again, with our bilateral stimulation that we can offer and the way we do this on a tailor-made basis, studying the PSG exam and pre-programming for activation chip, we can offer a solution where we stimulate precisely for a patient in function of his or her needs to maintain the airway open. To that extent, knowing that we have similar airway opening effects using the same stimulation parameters, supine and non-supine, this is, again, a great advantage that we offer and that we can contribute completely on the fact that we have a bilateral stimulation.

[Suraj Kalia, Managing Director at Oppenheimer]

Got it. And Olivier, for my follow-up question, if I could, I presume the label discussions start in Q3, I'm guessing, and also the 31 physicians, high-volume Inspire docs that you're considering presumably as low-hanging fruit and preaching the virtues of Genio, I'd love to understand how you're sensing the choice of device is going to shape up once you'll become commercial. Gentlemen, congrats on the progress, and thank you for taking my questions.

[Olivier Taelman, CEO at Nyxoah]

Well, thank you for the question, Suraj. And again, to your point, we also start opening the label discussion that is part of our module four submission. So that is what we will bring in. And based on our data, we will really pursue the option to have the supine position really explicit in our label. And I think based on this and I'm coming back to our mission, and that is making sleep simple again, based on this, for a physician, it becomes obvious, working with Genio, you know that you don't need to worry too much and that you can always maintain the airway of patients open regardless of their sleep position. And that is really, really a clear mindset.

[Operator]

One moment for the next question. Our next question comes from Adam Maeder with Piper Sandler. Your line is open.

[Adam Maeder, Managing Director at Piper Sandler]

Hi. Good evening, guys. Thank you for taking the questions and congrats on the progress. I wanted to start by asking about some of the preparations that you're making from a sales force and manufacturing standpoint. If I heard some of the remarks correctly, it sounds like that's the onboarding of U.S. sales folks is more back half loaded. But I was hoping you could get a little bit more granular there. So how many U.S. sales reps have you hired at the moment? Kind of how should we think about that building in the back half of the year? Where do you expect to be at launch? And then I guess just kind of a similar question, just talk about manufacturing capabilities and capacity and how you feel about that going into U.S. launch at the end of the year. And then I had a follow-up. Thanks.

[Olivier Taelman, CEO at Nyxoah]

Yeah. Well, thank you, Adam, for the question. So when we look at our launch strategy, as I mentioned earlier in the call, it's clear that currently, HGNS in the U.S. is a very concentrated business. So it allows us to have a laser-focused launch on top HGNS accounts, which constitute the vast majority of implants. Next to this, we want to develop a relationship with key sleep centers to drive referrals. So limited and efficient sales force sized appropriately for a targeted launch, which we can scale then opportunistically over time. Being very concrete, we plan to launch with a sales team of around 25 people being laser-focused on those top HGNS accounts.

[Olivier Taelman, CEO at Nyxoah]

Now, the scalability, patient follow-up strategy, which includes field clinical engineers to monitor implants and patient management specialists to focus on titration and patient follow-up. This increases the sales force capacity as sales reps can focus on lead generation and can also focus on what they are hired for, and that is increasing sales. There will be a limited DTC focus on product differentiation, of course. On top of this, we also will have a prior authorization team in place at launch. Now, how will we differentiate and how will we break the monopoly and take share from the competition?

[Olivier Taelman, CEO at Nyxoah]

A, we will focus on our superior efficacy due to the supine AHI reduction. I think I already was pretty clear about this. And B, we will have our product differentiation, no implantable pulse generator, implant for life, full scalability of our technology, a single incision, no leads, no risk for lead breakage. Those two will be our key factors that we will use within our sales force, the superior efficacy based on supine AHI reduction and product differentiation, making sleep simple again.

[Adam Maeder, Managing Director at Piper Sandler]

That's good color, Olivier. Just from a manufacturing standpoint, I don't think we need to spend too much time here, but just wanted to ask, check if you guys are indeed feeling good about the ability to manufacture and get the ground running in 2025 in the U.S. Then I had one follow-up. Thanks.

[Olivier Taelman, CEO at Nyxoah]

Yeah, correct. So for the U.S. sales specifically, we have contracted with a leading U.S. medical device manufacturer, incidentally also the same as competition is using, that will provide systems for the U.S. market at the first stage. Currently, we are having our Belgian manufacturing site for European commercial supply that will be further extended to also be able to supply for the U.S. And we are keeping our historical manufacturing facilities in Tel Aviv for clinical trial inventory. The manufacturing lines are highly scalable, particularly as we will launch with a ceramic encapsulation version of Genio, which is easier and less expensive to manufacture.

[Adam Maeder, Managing Director at Piper Sandler]

Yeah. Good color there, Olivier. Thank you for that. For the follow-up, I wanted to switch over to reimbursement and ask for more color about the strategic partnership with AAO-HNSF. What more can you tell us about kind of the background of that agreement or the genesis of the agreement? I'll also ask any update in terms of how we're thinking about coding vehicle for Genio in the U.S. and just pace of payer coverage in the United States. It sounds like you expect U.S. payers to come on pretty quickly after approval, but maybe just talk about the confidence there. Thank you for taking the questions.

[Olivier Taelman, CEO at Nyxoah]

Yeah. No, no. Definitely. So we are partnered with AAO, which will make a formal recommendation on an interim CPT code for us to use at launch, directly at launch when we have obtained FDA approval. At launch, doctors will submit Medicare claims using the AAO-recommended CPT code, which will closely match the Genio procedure and is currently covered by all Medicare administrative contractors or MACS. Reimbursement will be in line with current HGNS payment rates. And I think that's also important. We will pursue a Genio-specific CPT code over time, but based upon precedent, this will likely take a couple of years. Now, in going forward, we know that all the MACS have local coverage decisions for HGNS. And in collaboration with them, we will draft limited coverage articles for Genio that will leverage those decisions.

[Olivier Taelman, CEO at Nyxoah]

We have the full influence and support of the AAO for our strategy demonstrated in their recent partnership.

[Operator]

One moment for the next question. The next question comes from Ross Osborn with Cantor Fitzgerald. Your line is open.

[Ross Osborn, Director at Cantor Fitzgerald]

Hey, guys. Thanks for taking our questions. Maybe just one for me. I would be curious to hear if there's any update on the ACCESS trial and then how you think education efforts will progress post-data there in the U.S. in terms of being able to utilize your offering with CCC patients, which historically has not been done. Thank you.

[Olivier Taelman, CEO at Nyxoah]

Thank you, Ross. Thank you for the question. We continue to make progress with the ACCESS study. As I mentioned before, we will not be disclosing the number of patients implanted. That said, we still plan to close implants by the end of this year, by the end of 2024. Once we close the study, there will be a 12-month follow-up that will bring us to the end of 2025. We will file a PMA supplement. Therefore, we anticipate a 6-9-month review period. We expect to receive a label expansion in mid-2026. I know this was not really the question, but I do think it's important also to strategically carve out when I was talking about supine versus non-supine, we're also looking and dreaming at non-CCC patients.

[Olivier Taelman, CEO at Nyxoah]

There, we are really making sleep simple again by physicians not having to worry about in what position people are sleeping. Now, when you look at CCC patients versus non-CCC, again, this is under the same umbrella in our strategy in making sleep simple again that over time, also physicians don't need to worry whether a patient is suffering from CCC or non-CCC. Not to forget, this will also eliminate the risk of currently in place to further determine whether a patient is a CCC or a non-CCC patient. So all this together, Ross, is once again part of our mission. We want to make and we want to offer a solution that will make sleep simple and where physicians and patients can realize they have a safe solution that will be effective regardless of how they sleep and that can mimic, in fact, a natural night's sleep.

[Ross Osborn, Director at Cantor Fitzgerald]

Great. Thank you.

[Operator]

One moment for the next question. The next question comes from David Rescott with Baird. Your line is now open.

[David Rescott, Senior Research Analyst at Baird]

Oh, great. Thanks for taking the questions here and congrats on the progress so far this year. I wanted to start on Germany. I want to make sure I heard a couple of things correct, that for the full year, maybe you actually hit a 27% share, closer to 50% in the fourth quarter. Wondering if you have a sense for the number of centers that you're in today and then whether or not, or just any more color on the progress with the partnership you have with ResMed out there, that I have a follow-up.

[Olivier Taelman, CEO at Nyxoah]

Yes. No, no. Definitely. So first of all, today, you were correct in understanding the 27% market share for the total year in 2023. And today, we can say that we have 51 centers that are fully trained and ready to implant and/or implanting the Genio technology. So 51. That's where we stand today. When it comes to our ResMed partnership, our main goal through the partnership is further developing a patient-centric approach by developing a complete OSA ecosystem where patients can be guided to whichever OSA therapy best suits their needs. We are collaborating on DTC initiatives and sales and marketing efforts to target both sleep physicians and ENT surgeons. The goal of the partnership is to expand OSA therapy penetration and, of course, to increase our market share in Germany.

[David Rescott, Senior Research Analyst at Baird]

Okay. Great. I wanted to ask maybe about some of the commercialization thoughts, high-level thoughts in the U.S. If I heard you correctly, I think you're looking to bring on 25 dedicated U.S. salespeople. And just wondering what you think the addressable or the immediate opportunity for those salespeople could be, meaning if we're modeling 200 centers or so coming online with about one implant per center per month, can the 25 sales reps that you initially have in 2025 expand that level or support that level of growth, or do you need to continually add as you get into 2025 and 2026? Thank you.

[Olivier Taelman, CEO at Nyxoah]

No, no. It's a very valid question. I can tell you it's also a question that keeps us busy internally in defining and see how we can make the most successful launch going forward. Now, as I mentioned, we will start with a laser-focused launch on top HGNS because to provide you some colors, we are not going after 200 accounts from the get-go for the simple reason that we want to ensure high implant quality. And therefore, we need to train the surgeons in a quality way, of course, also being time-conscious, but we have to put the quality always first because we want to have our first patients also showing the success that we see in our clinical data. So that's number one. So it will not be 200 accounts, but more 75-100 accounts.

[Olivier Taelman, CEO at Nyxoah]

When we go a little bit more in-depth, how do we define our launch success? I mean, there are a couple of parameters. First is breaking the monopoly that currently is existing when it comes to HGNS in the U.S. and expanding the HGNS market. That is one of our strategies. Next, of course, we want to exceed the street expectations. And third, we want to make sure that we can extend our cash runway to mid-2026 with a focused and scalable commercialization strategy. I think those three things are extremely important. So you can expect that the 25 salespeople will all have 4-5 implant accounts from the get-go and that we expect every account to do minimum an implant a week, if not 2 implants a week so that then you can start modeling it out in your model.

[David Rescott, Senior Research Analyst at Baird]

All right. That's very helpful. Thanks so much.

[Operator]

Our last question will come from Mike Polark with Wolfe Research. Your line is now open.

[Mike Polark, Senior Research Analyst at Wolfe Research]

Good afternoon. Good evening. I'm curious, is Dr. Boone on the call?

[Olivier Taelman, CEO at Nyxoah]

He's not on this call. He just started, but he will be on the next call, Mike. You can be sure and there will also be opportunities when we will host an investor and an analyst day that you can talk extensively to him or with him.

[Mike Polark, Senior Research Analyst at Wolfe Research]

Okay. Sounds good. We'll leave that for then. I did have one other personnel question. I noticed Christoph Eigenmann left the company, the Chief Commercial Officer you hired last year. And I'm just curious what happened there and kind of what is the plan for U.S. sales leadership? It sounds like you're moving forward with hiring a field force, but I'm curious if you plan to backfill for Christoph. And if so, where is that process and what kind of characteristics are you looking for in a candidate?

[Olivier Taelman, CEO at Nyxoah]

Yeah. No, no. And definitely. So first of all, I will not comment too much because out of respect also for Christoph when he was joining us, who really worked hard and did a good job. But sometimes it's not that easy to really make a transfer from a large company into a startup company where we are because there are totally different expectations. And I do think that it was the best solution for both Christoph and Nyxoah to explore other opportunities and to have our ways separating.

[Olivier Taelman, CEO at Nyxoah]

Now, that being said, it illustrated again for us how careful we have to be in this recruitment process and how we, in fact, also incorporate the learnings to find, I call it, the unicorn leader that the U.S. market deserves and that also the U.S. team will deserve to have a successful launch. So the process is ongoing. We have several candidates that we met. We are now having a shortlist. Together with our board and also with some other members of our team, including Dr. Boone, we will be shortly announcing our new CCO and then also help us prepare the U.S. launch.

[Mike Polark, Senior Research Analyst at Wolfe Research]

Thank you so much.

[Operator]

Ladies and gentlemen, that does conclude the Q&A session and today's conference call. Thank you for participating. You may now disconnect.

Participants

Executives

• Loïc Moreau, CFO
• Mickaela Kirkwood, Investor Relations and Communications Manager
• Olivier Taelman, CEO

Analysts

• Adam Maeder, Managing Director at Piper Sandler
• David Rescott, Senior Research Analyst at Baird
• Jon Block, Managing Director at Stifel
• Mike Polark, Senior Research Analyst at Wolfe Research
• Ross Osborn, Director at Cantor Fitzgerald
• Suraj Kalia, Managing Director at Oppenheimer