Nyxoah Q4 2024 Earnings Report

Nyxoah EPS Results

• Actual EPS: -$0.49
• Consensus EPS: -$0.46
• Beat/Miss: Missed by -$0.03
• One Year Ago EPS: N/A

Nyxoah Revenue Results

• Actual Revenue: $1.35 million
• Expected Revenue: $2.02 million
• Beat/Miss: Missed by -$665.00 thousand
• YoY Revenue Growth: N/A

Nyxoah Announcement Details

• Quarter: Q4 2024
• Date: 3/13/2025
• Time: After Market Closes
• Conference Call Date: Thursday, March 13, 2025
• Conference Call Time: 8:00AM ET

Nyxoah (NASDAQ:NYXH), a medical technology company, focuses on the development and commercialization of solutions to treat sleep disordered breathing conditions. The company's lead solution comprises Genio system, a CE-Marked, patient-centric, and hypoglossal neurostimulation therapy to treat moderate to severe obstructive sleep apnea. Nyxoah S.A. was incorporated in 2009 and is headquartered in Mont-Saint-Guibert, Belgium.

Nyxoah Q4 2024 Earnings Call Transcript

Key Takeaways

• DREAM pivotal study met both primary and secondary endpoints with a 63.5% AHI responder rate, 71.3% ODI responder rate and demonstrated consistent supine efficacy, including 82% of subjects achieving “super responder” status (AHI below 15).
• FDA approval remains on track with the final PMA module submitted and interactive FDA dialogue ongoing, and the company expects U.S. clearance by the end of March 2025.
• The company has built a 50-member U.S. commercial team, trained over 75 physicians, and is deploying a two-pronged launch strategy targeting high-volume AGNS centers and sleep specialist referral networks using CPT code 64568.
• In Europe, Q4 revenue was €1.9 million (ex-deferred patches) for 46% sequential growth, full-year revenue reached €5.1 million (+18% year-over-year), and product launches occurred in the U.K. NHS program and the Middle East.
• Q4 operating loss widened to €18.3 million (versus €10.8 million a year ago) driven by R&D and U.S. commercialization investments, while cash reserves remained strong at €85.6 million as of December 31, 2024.

Presentation

[Operator]

Hello, and welcome to NixaWalt Fourth Quarter twenty twenty four Earnings Conference Call. At this time, all participants are in a listen only mode. After the speaker's presentation, there will be a question and answer session. To ask the question during the session, you will need to press 11 on your telephone. I would now like to turn the conference over to John Landry.

[Operator]

You may begin.

[John Landry, CFO at Nyxoah]

Thank you. Good morning, everyone, and I welcome you to our earnings call for the fourth quarter and full year '20 '20 '4. Participating from the company today will be Olivier Talman, Chief Executive Officer and myself, John Landry, Chief Financial Officer. During the call, we will discuss our operating activities and review our fourth quarter and full year twenty twenty four financial results released before U. S.

[John Landry, CFO at Nyxoah]

Market opening 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 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. All forward looking statements are based upon our current estimates and various assumptions.

[John Landry, CFO at Nyxoah]

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 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 03/13/2025. With that, I will now turn the call over to Olivier.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Thank you, John. Good day, everyone, and thank you for joining us for our fourth quarter and full year twenty twenty four earnings call. 2024 was a transformative year for NixoVA. With tremendous progress made throughout the year, we are extremely well positioned to bring Jynneo to market in The U. S.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

By the end of this month. We have proven that Jynneo can deliver best in class outcomes for obstructive sleep apnea patients. Our pivotal study DREAM met both its primary and secondary endpoints. The DREAM study demonstrated a strong AHI responder rate of 63.5% and an ODI responder rate of 71.3% with an overall median AHI reduction of seventy point eight percent. Importantly, through the study, we demonstrated that Jynneo is the only therapy with explicit clinical evidence based data proving its ability to maintain its efficacy irrespective of a patient's sleeping position.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

This is a critical differentiator as people sleep on average between 35 to 40% of the night on their back. And based on published data, the number of times per hour that a patient stops breathing can double while in a supine position. Genu stands alone with clinical trial data specifically validating this claim, making it the most consistently effective solution for patients throughout the entire night of their sleep. While our DREAM study uniquely required the minimum of sixty minutes of supine sleep time, on average all subjects slept one hundred and fourteen minutes in a supine position. The study measured position specific outcomes and demonstrated a 66.6 median AHI reduction while sleeping in a supine position.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Despite the fact that the number of airway obstructions can double in this position. This reduction compares favorably to the 71% median reduction shown while sleeping in a non supine position. And this consistent efficacy across sleep positions make Jynneo the most effective solution for patients throughout the entire night of sleep, unlike competing technologies where supine sleep efficacy data has not been disclosed. Additionally, ONDREAM data revealed another significant clinical advantage. Jynneo produces a remarkable percentage of what we refer to as super responders.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Patients whose AHI scores is dropping below 15, effectively returning their mortality and cardiovascular risk to levels comparable to individuals not suffering from OSA. Eighty two percent of all DREAMS subjects achieved this result. This represents a profound clinical impact that goes beyond symptom management to potentially extending patient lives. The combination of the supine and super responder data makes Jynneo a differentiated and unique solution for patients with OSA. In addition to these strong efficacy results, Jynneo also demonstrated a favorable safety profile with an eight point seven percent severe adverse event rate.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

We believe that this efficacy and safety profile will have a positive impact on therapy selection by physicians and therapy acceptance by patients compared to the current available AGNS solution. Let me now switch to the regulatory perspective. We have submitted the fourth and final module of our PMA submission in June 24. We continue to have a very interactive dialogue with the FDA and have successfully completed the remaining requirements, including this Belgium site visit, which has previously been delayed due to circumstances unrelated to NixoVA. Based on our current interactions with FDA, where the focus is now on labeling, we continue to expect to receive FDA approval by the March.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

In preparation for our U. S. Commercial launch, we have built a world class team in support of our U. S. Go to market strategy and commercial readiness plan.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Notably, I moved with the family to The U. S. To be on the ground during this critical period. In addition, we have built our U. S.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Based senior management team including hiring John Landry as Chief Financial Officer, Doctor. Moritz Boone as Chief Medical Officer and Scott Holstein as Chief Commercial Officer. In addition, we have industry leading talent in place with a track record in OSA and our neuromodulation across our sales, marketing, reimbursement and medical affairs teams in The U. S. Our strategy for penetrating The U.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

S. Market revolves around two pronged approaches. First, as a smart follower, we will target high volume AGNS implanting centers where physicians and patients are actively seeking an alternative solution to current therapy. In addition to these patients, we have also identified significant demands from patients who are hesitant about receiving a pacemaker like implant for OSA and whose physicians have been eagerly awaiting a compelling alternative to offer them. Importantly, as a result of our clinical trials in The U.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

S, there are already 75 physicians that have been trained on the Genio technology and are familiar with its unique features and patient outcomes. Second, through focused commercial investments, we will develop strong referral networks with suite physicians, who manage large population of moderate to severe OSA patients where AGNS is not yet fully embedded in their treatment pathway. As a company that prioritize clinical evidence and patient outcomes, over simplified marketing messages, we believe in setting realistic expectations and partnering with physicians to find the optimal treatment for each patient, as this is part of our mission in pulling the patients first. We plan to launch in The U. S.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

With 50 commercial team members, comprising sales, marketing and market access professionals, who are currently all hired and trained with plans to scale quarter after quarter. This team will be supported by focused direct to consumer initiatives and dedicated reimbursement support. Regarding reimbursement, we have identified and established CPT code that we plan to utilize at launch. The CPT code to be very precise is 64568. This CPT code has been recognized by commercial and government payers for OSA indication and is the same CPT code used for the current FDA approved AGNS technology.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

We expect this will allow us to align on pricing, while we will differentiating on our unique technology and clinical outcomes. We are working closely with the American Academy of Otolaryngology and participating in the FDA's early payer feedback program to educate CMS and major commercial payers on Jynneal on the impact it can have on their patients. While our primary focus as a company has been on preparing for a U. S. Launch, we also continue to be encouraged by our growth and what we learned in Europe.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Our commercial proof of concept in Germany has provided valuable insights that we are actively incorporating into our U. S. Launch strategy. Our growth in Europe was primarily driven by the continued execution of our commercial strategy in Germany. As John will detail in his remarks, we are now recording a portion of our disposable patch revenue as deferred revenue.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Our revenue would have been $1,900,000 in the fourth quarter of twenty twenty four, excluding the impact of this deferral. This represents a 46% sequential growth over Q3 twenty twenty four. For the full year, we have delivered revenue of EUR 5,100,000.0 and an 18% increase over 2023. We have also continued to expand our geographic footprint in the region. In December, we launched Genio in The United Kingdom.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

The Genio system is covered under the NHS Specialized Service Device Program, which makes us believe that The UK has the potential to become one of our largest international markets. Based on the first successful implant at University College London's Hospital, there was a lot of excitement created from Jynho in The UK. And we look forward to further expanding into other hospitals across the country and scaling our sales force. In addition, we have launched in The United Arab Emirates with the first commercial implant done in Dubai's German Saudi hospital. This represents a unique milestone as Jynneo was the first AGNS implant performed in The Middle East.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Collectively, all of our accomplishments in 2024 brought us at this point. We are now on the verge of bringing a truly innovative OSA solution to The U. S. Market where there still exists a massive patient population in need of treatment that can benefit from our Jynneos solution. Both we and the clinical community are incredibly excited about what the rest of 2025 has in store.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

With that, I'll turn the call over to our CFO, John Laundry for a financial update.

[John Landry, CFO at Nyxoah]

Thank you, Olivier. As Olivier mentioned in his earlier remarks, we deferred revenue related to disposable patches in the fourth quarter of twenty twenty four. As part of our contracts with customers, we deliver additional disposable patches on top of those included in the initial delivery of a Genio system. Beginning in the fourth quarter, the portion of the selling price for a Genio system related to these additional disposable patches will be recognized as deferred revenue. This deferred revenue will be recognized as revenue over time as the disposable patches are delivered to the customer.

[John Landry, CFO at Nyxoah]

We recorded deferred revenue of in the fourth quarter of twenty twenty four. Recognized revenue is million in the fourth quarter and EUR 4,500,000.0 for the full year 2024. Total operating loss for the fourth quarter of twenty twenty four was EUR 18,300,000.0 versus EUR 10,800,000.0 in the fourth quarter of twenty twenty three, driven by the acceleration in the company's R and D spending, ongoing commercial and clinical activities and an acceleration in commercial investments in The U. S. Cash position remained strong at €85,600,000 at 12/31/2024 compared to million at the end of twenty twenty three.

[John Landry, CFO at Nyxoah]

This includes proceeds from our million ATM equity raise early in the fourth quarter and reflects our disciplined approach to managing cash burn as we prepare for FDA approval and U. S. Commercialization. With that, I would now like to hand the call back to Olivier to discuss his thoughts on 2025. Olivier?

[John Landry, CFO at Nyxoah]

Thank you.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Before we conclude, I want to emphasize that this is a truly and exciting time for Nexo one. With all of the fantastic work of our organization during 2024, we are incredibly well positioned for the future. Looking ahead to 2025, the U. S. Will be our key focus.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Based on our current interaction with the FDA, where the focus is now on labeling, we continue to expect to receive FDA approval later this month or by the March in 2025. We have been able to identify a CPT code well known by payers in the OSA indication, which will allow us to establish competitive pricing compared to the current FDA approved hGNS technology. Second, we hired and trained the U. S. Commercial team that is ready to launch upon FDA approval with a two pronged strategy acting as a smart follower focused on high volume hGNS sites in combination with the focused commercial investments in developing referral networks for sleep physicians who manage large population of OSA patients.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Our success will be measured in entering these new accounts and driving new patients to Jynneal coming from this referral network, ultimately resulting in market share gains. Lastly, in international markets, we will further increase Jynneo's penetration within Germany, but also within The UK, And we will selectively expand into new targeted international geographies such as The UAE. Twenty Twenty Five will be a transformative year in NyxoA's growth as we make significant progress towards our mission of making sleep simple by bringing the Genius Solution to OSA patients in The U. S. And further expand internationally.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

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

[Operator]

Thank Our first question comes from the line of Adam Mater with Piper Sandler. Your line is open.

[Adam Maeder, Senior Research Analyst at Piper Sandler Companies]

Hi, good morning, Olivier and John. Thank you for taking the questions and great to hear you still expect approval here by the end of the month. A lot of different questions that I could ask here, but maybe just to start on reimbursement, the new update there, you said you're going to use the 645688 code. There is some investor consternation that that level of reimbursement associated with the code is not overly attractive or sufficient for hypoglossal nerve stimulation in particular to the physician. So what's your response to that?

[Adam Maeder, Senior Research Analyst at Piper Sandler Companies]

And do you believe this coding strategy is sufficient to drive strong update of Genio? And then I had a follow-up. Thanks.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Thank you, Adam. So first of all, I do agree with you that for a physician fee perspective, this is not the strongest code. On the other hand, if you look at NKSORA, when we will enter the market, I think it's so important for us to be able to enter and having directly a CPT code that can represent payment for technology. So from our perspective, we are extremely pleased that we have identified the code because I realized that this was one of the open topics in our preparation for U. S.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Launch. Now on the other hand, I do think there is still a lot of work that needs to be done in this scoping and also reflecting a stronger pricing and making it even more attractive for physicians. Last, while I would like to comment on this, we will also explore in order to optimize the uniqueness of Jynho and the technology offering a bilateral simulation compared to a unilateral simulation, so that we can maybe make it even more attractive linked to our product differentiation. But as a summary, we are happy that we have a code and we also would like to point out that the code is the same for a physician for both the existing the current AGNS technology that is available and the GEMEO technology that will be available.

[Adam Maeder, Senior Research Analyst at Piper Sandler Companies]

Understood and really helpful color there. Thanks for that Olivier. For the follow-up, maybe just one on how you're thinking about the trajectory of U. S. Launch.

[Adam Maeder, Senior Research Analyst at Piper Sandler Companies]

I'll ask the question kind of this way. So I think I heard you mentioned 75 docs. I think those are U. S. Docs are trained on the Genio technology already.

[Adam Maeder, Senior Research Analyst at Piper Sandler Companies]

How do we think about the pace of new account openings this year? I know the strategy is concentrated deep not wide, but just is there a target number in mind for 2025? Just help us understand the strategy there. Thank you.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

First of all, when we are talking about 75, it's a little bit more than 75. All physicians were part of the clinical study DREAM, ACCESS and also usability study we did. And I think what was enormous rewarding for us was hearing that all physicians are actively asking and reaching out when will be available and that they want to have Genu integrated in their treatment path to treat OSA patients. That's the first step. Second one is, as I mentioned, we have a 50 headed sales team that is currently fully trained and ready to launch.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

So now how will we approach this? Remember that the current AGNS business is very concentrated with roughly 300 to three fifty sites representing, let's say, 70% to 75% of total AGNS revenue. So those will be the targeted accounts, the 300 to three fifty. With the 50 people, we will start, we will train and educate our surgeons. Every quarter we will further scale up and we also have a playbook for scalability in adding additional sales reps quarter after quarter.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

So our first challenge will be let's get the first positions trained, then we start expanding quarter after quarter. And I do think that in a period of twelve to eighteen months, we will be able to cover all those Tier one high volume HRS accounts.

[Adam Maeder, Senior Research Analyst at Piper Sandler Companies]

Very helpful. Thank you.

[Operator]

Thank you. Please stand by for our next question. Our next question comes from the line of John Block with Stifel. Your line is open.

[Jonathan Block, Managing Director at Stifel Financial Corp]

Great. Thanks guys and good morning.

[Jonathan Block, Managing Director at Stifel Financial Corp]

Olivia, it seems that

[Jonathan Block, Managing Director at Stifel Financial Corp]

the dialogue with the FDA per your comments has been consistent and thorough. However, just when I look at the calendar, the March is relatively soon. We hear about all these cuts at the agency that are taking place. So maybe if you can give us a little bit more color on why still the confidence by the end of this month, the March? And then maybe even more importantly, what are your thoughts for the label, because again, it seems like you're in the final stages, your thoughts for the label and the likelihood that those supine claims that you talked about are included upon approval?

[Jonathan Block, Managing Director at Stifel Financial Corp]

And then I'll ask my follow-up. Thanks.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Thank you, John, for the question. And first of all, indeed, it has been very challenging times for government and lately. So when it comes to our file and the review, I am pleased and I stay very carefully when I'm saying this, but I'm pleased that so far we have not seen any negative impact of the ongoing political change that are impacting the government procedure. So that is already one step. So from that end, we are still good.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Now over the last weeks, it has been extremely interactive with the FDA going back and forth, closing and announcing the last questions and also entering the labeling discussion. So when you talk about timing and why we still feel confident by the end of this month, I think I mentioned earlier that there is something like a ninety day clock and the ninety day clock is ending end of this month. So that's why I was still confident that no changes in our review that entering the last stage with the labeling discussion and also knowing that the clock is ticking that it makes sense to still say that we expect to have an approval by the end of this month. That is hopefully answering the first part of the question. For the second one, more specific on the labeling, I mean, it's clear that we would like to have also the uniqueness with our supine data being reflected in the label.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

And that is also the path that we present to FDA. It also has to be clear that with our existing clinical evidence on CCC patients and also the worry that we are seeing in The U. S. In access study that we also do not see any reason to have CCC as a cochranegication as compared to the current available AGNS technology that has CCC as a cochranegication. We do feel strong that this will not be the case, but maybe conclusion, I do not want to jump to any conclusions until FDA made up its final mind, but in our label discussion to answer your questions, those are two things that we are currently actively discussing.

[Jonathan Block, Managing Director at Stifel Financial Corp]

That was great. That was great color. Thank you. And then second question sort of follows up on where Adam was going, maybe from a little bit of a different perspective. Just on that ramp or on the trajectory, how do we think about the commercial payers coming on board?

[Jonathan Block, Managing Director at Stifel Financial Corp]

Do you feel confident you have at least one here in 2025? Do you have a handful? And do you need some of these studies peer reviewed to help sort of stimulate or move that process forward? Thank you.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Yes. So first of all, and I mentioned this already a couple of times, our competitor has done a terrific job educating commercial payers about the benefits of AGNS and sometimes it's nice to be second. I mean, I can only compliment and applaud this. Now when it comes to our strategy, also here, we will work with pre authorizations. We will have already patients lined up and we will have a lot of pre authorizations in place the moment we have FDA approval and moving forward.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

We do think it's fairly realistic to expect the first commercial payers during quarter three, quarter '4 this year. And of course, next to them, we have the government payers like CMS, Medicare, where we do expect to have payment right from the

[Olivier Taelman, CEO & Executive Director at Nyxoah]

beginning.

[Jonathan Block, Managing Director at Stifel Financial Corp]

Thanks guys.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Thank you, John.

[Operator]

Please standby for our next question. Our next question comes from the line of Ross Osborne with Cantor Fitzgerald. Your line is open.

[Matthew Park, Equity Research Associate at Cantor Fitzgerald]

Hey guys, this is Matthew Park on for Ross today. Thanks for taking the questions. I guess just to start off, can you walk us through any manufacturing supply chain that you guys currently have in place? And do you think it's sufficient to meet existing demand upon approval?

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Yes. Well, thank you for the question. And you're pointing out such an important question. I mean, this is what every company wants to have. When you launch, you need to make sure you have product and you have sufficient manufacturing and inventory available.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

So also for NISTOLA, this is one of our key points and the team has worked in SOLAAR. And I'm happy to say that also there we feel really confident. Now one more topic, but I also would like to point out is that we are manufacturing products for The U. S. Market also in The U.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

S. This was a decision that was made already a couple of years ago. And I think I see also the current landscape that this was also the right decision. So not only we have significant inventory, we also do not have to ship inventory around the globe. It is manufactured in The U.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

S. For The U. S. Also being part of our U. S.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Focus as a company that we have.

[Matthew Park, Equity Research Associate at Cantor Fitzgerald]

Got it. That's super helpful. And then just one more from me, kind of to bounce off what John was getting at earlier. Would you just do you anticipate needing any real world data upon approval? And what would any potential timelines look like there to drive incremental adoption?

[Matthew Park, Equity Research Associate at Cantor Fitzgerald]

Thanks for taking the question.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

My apologies, but the first you were not clear in the first part of the question. We had a bad line. Can you please repeat? Yes.

[Matthew Park, Equity Research Associate at Cantor Fitzgerald]

Do you anticipate needing to generate any real world data upon approval? And what would any potential timelines for this look like?

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Yes. Yes,

[John Landry, CFO at Nyxoah]

I think we'll probably continue this is John here. So as we continue to go forward, we'll definitely want to collect real world data, real world experience, so we can better articulate the clinical and economic justification of our technology. So as we go forward, that will be an important part of our process in place.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

I'm sorry, because I was it was difficult for me to understand the question. But of course, as part of the PMS post market study approval, it is meant that we also do start collecting real world data once we are launching. So yes, this is definitely the opportunity.

[Matthew Park, Equity Research Associate at Cantor Fitzgerald]

Got it. That's super helpful. Thanks guys.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Thank you.

[Operator]

Please standby for our next question. Our next question comes from the line of Suraj Kalia with Oppenheimer and Company. Your line is open.

[Suraj Kalia, Managing Director at Oppenheimer & Co. Inc.]

Hey, Olivier, John, congrats on all the progress. Can you hear me all right?

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Yes, I can.

[Suraj Kalia, Managing Director at Oppenheimer & Co. Inc.]

Perfect. So, Olivier, obviously, you guys have had quite a bit of experience in Germany. As you all prep for U. S. Launch, the 75 or so docs that you all are targeting, Olivier, to the extent that lessons learned from Germany, how do you think what do you think is the key catch for Jynio versus Inspire?

[Suraj Kalia, Managing Director at Oppenheimer & Co. Inc.]

Is it the supine versus non supine? Is it bilateral? Is it just physicians looking to diversify? Is it your CCC angle? Just help us understand where do you think the hook is going to be for these initial low hanging fruit of 75 physicians?

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Yes. And thank you for this question. So now going back to Germany and our initial learnings, offering physicians and patients a choice in AGRS implants and stepping away from an invasive pacemaker solution into a single incision procedure has been key in the first introduction with the technology. Then of course, they explored further product differentiation. They see the benefits from bilateral stimulation.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

They also see the uniqueness with patients in order to upgrade their system without the need for resurgery and also of course avoiding the risk I2 for another surgery for replacement of a battery. So that's what we saw initially. Now while we are further scaling in Germany and learning, we're also seeing that physicians more and more also tend to understand how important it is that patients are very compliant with their technology. And also there we are seeing that with our wearable component that creates a habit of before you go to bed, having your wearable ready to get a good night's sleep expressed in a compliance ratio of more than 85%. This is also something that is driving the physician next to the results that they have seen including this to continue choosing for Genia.

[Suraj Kalia, Managing Director at Oppenheimer & Co. Inc.]

Got it. And as my follow-up, Olivier, maybe I missed it in your prepared remarks. Any update on timing of Dream publication and also status of enrollment and access? Gentlemen, thank you for taking my questions.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Yes. And that's an excellent question on the dream publication. So submission has been made. It's currently under review and we expect publication in the leading medical journal. We expect this publication in the coming months.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

I mean, we cannot define how fast the review process is going, but the submission has been done and then we really expect to have it out definitely for summer. So when it comes to access, so there we continue to make good progress. We will not disclose the precise number since we never did this, but we do expect to complete enrollment by mid-twenty twenty five. And then the next steps, Sheila, as you know very well, which will be a PMA supplement. And after this, therefore, we expect that we will have late twenty twenty six beginning 2027 of potential label expansion.

[Suraj Kalia, Managing Director at Oppenheimer & Co. Inc.]

Thank you.

[Operator]

Thank you. Our final question comes from the line of David Rescotte with Baird. Your line is open.

[David Rescott, Senior Research Analyst at Baird]

Great. Thanks for taking the questions here. Olivia, I heard your comments on the what's given you confidence in the March approval timeframe and the ninety day clock that you have. First, I want to clarify, I think you said the Belgium site visit did happen, so I wanted to clarify that. But second, I'm not sure if you have any events scheduled between now and April.

[David Rescott, Senior Research Analyst at Baird]

But let's say we do get to April 1 and we haven't seen a press release at all from the team around approval. What would you maybe suspect? Not necessarily could have gone wrong, but could have been a cause maybe for you not to meet that window, just essentially trying to help you get out in front of what could be a question arising in a couple of weeks or so?

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Yes. So first of all, David, we are still planning, as I was mentioning, to have really a press release of beforehand of March based on the argument I used. If we want to go completely in detail, there is something like a ten day grace period that FDA has that exists. We have no indication whatever that this would apply to us. So we are still and we remain confident that before the March, we will have more communication coming out.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

And to your point, if we do not have any further news, I think it's highly unlikely for us. So in conclusion, we remain confident. There is a grace period that exists, no indicator pointing in that direction. So short answer is, I do expect that I will be back for April 1 with some positive markets.

[David Rescott, Senior Research Analyst at Baird]

Okay, very helpful. And then maybe on reimbursement, again, I heard the comments there already on the code that you plan on using. But from the commercial side or sorry, from the Medicare kind of CMS side, I guess, can you help us think about maybe how you're sizing up the potential opportunity of patients that would fall within the Medicare reimbursed bucket versus those that could be potential patients when you expand the commercial coverage? And when you think about the progression of this rolling out essentially on day one, do you have I don't know if you'd call it confirmation, but do you have some visibility from CMS that they definitively will accept using that code for your device and do you expect maybe some hurdles as you roll out in the early days around the maybe prior auth pathway to get those covered? Do you think that pretty much for all of 2025, you should have a pretty similar type of prior auth approval pathway for the system with this code?

[David Rescott, Senior Research Analyst at Baird]

Or do you think again maybe there's some hurdles early on that pushes more of ease of adoption and the reimbursement pathway more towards the second half of the year? Thank you.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

So I do think we can state that roughly 20% to 30% of payment is done by Medicare, specifically related to OSA patients also knowing the average age. On the other hand, we know that there are local decisions that need to be made and then we also ask and we are updating also the local max due to the using the FDA early payer program. So we do not have the full influence on how fast things will go or I could not really comment in detail from a commercial payer perspective how fast periodization process is going and who will be the first picking it up. But I hope you will read as well that when there is an established CPT code that they recognize for all the same payment. And since we fall under this code, if you look at technicalities of our product, we do also feel very confident that this will happen quite fast.

[Olivier Taelman, CEO & Executive Director at Nyxoah]

And we continue working closely with the AAO on supporting us. And of course, the education through the early payer program is definitely also helping us in the move forward.

[David Rescott, Senior Research Analyst at Baird]

Okay. Thank you.

[Operator]

Thank you. Please stand by. We do have another question in the queue. Our next question comes from the line of Paige Chamberlain with Wolfe Research. Your line is open.

[Paige Chamberlain, Senior Equity Research Associate at Wolfe Research, LLC]

Hi. Good morning, guys. This is Paige on for Mike Pollark. First question, on the code, CPT code 64568, the description we believe includes pulse generator. So that's obviously different than HENEO's form factor.

[Paige Chamberlain, Senior Equity Research Associate at Wolfe Research, LLC]

Why are you guys confident that HENEO fits into this code category?

[Olivier Taelman, CEO & Executive Director at Nyxoah]

Because we do have a pulse generator. I mean, you need to have a battery and the only difference is that we have an external pulse generator and with Pacemaker, we have an internal pulse generator. And to your point, as you mentioned, very precise, the code capture on the pulse generator and we do have one.

[Paige Chamberlain, Senior Equity Research Associate at Wolfe Research, LLC]

Awesome. Thank you. And then just one quick follow-up on the deferred revenue recognition change. Can you guys help us understand what portion of a new patient implant will be deferred in the future? And then does this mean that a patient needs to be compliant and use the patches over the period of use to be able to record the deferred revenue down the line?

[Paige Chamberlain, Senior Equity Research Associate at Wolfe Research, LLC]

Thank you so much.

[John Landry, CFO at Nyxoah]

Yes. Thank you, Paige. So in terms of the percentage, it's a small percentage of the total selling price of the Genio implant. So it's a small percentage that will be deferring over time at this point. And that percentage will continue to decrease over time for a couple of reasons.

[John Landry, CFO at Nyxoah]

The cost and the ascribed value of the disposal patches decrease, they'll reduce the amount of the deferral that we have going forward. And then in terms of compliance, there's no specific compliance requirement associated with deferred revenue. So the deferred revenue will be recorded and recognized as revenue as the patient utilizes devices and we ship the devices out to a patient. But there is no requirement for, some sort of compliance metric, similar to CPAP usage.

[Operator]

Thank you. Ladies and gentlemen, I'm showing no further questions in the queue. That concludes today's conference call. Thank you for your participation. You may now disconnect.

Participants

Executives

• John Landry, CFO
• Olivier Taelman, CEO & Executive Director

Analysts

• Adam Maeder, Senior Research Analyst at Piper Sandler Companies
• Jonathan Block, Managing Director at Stifel Financial Corp
• Matthew Park, Equity Research Associate at Cantor Fitzgerald
• Suraj Kalia, Managing Director at Oppenheimer & Co. Inc.
• David Rescott, Senior Research Analyst at Baird
• Paige Chamberlain, Senior Equity Research Associate at Wolfe Research, LLC