Q4 2024 Nyxoah SA Earnings Call

Operator: Good morning, everyone. And I welcome you to our earnings call for the fourth quarter and full year 2024. Participating for the company today will be Olivier Taelman, 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 2024 financial results released before U.S. market opening today.

Thank you good morning, everyone and I welcome you to our earnings call for the fourth quarter and full year 2024.

John Landry: Participating for the company today will be Olivier Talman, Chief Executive Officer, and myself, John Landry Chief Financial Officer during.

John Landry: During the call we will discuss our operating activities and review our fourth quarter and full year 2024 financial results released before U S market opening today after we which we will host a question and answer session.

Operator: 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.

John Landry: 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.

Operator: 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. 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.

John Landry: 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: 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.

John Landry: 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.

Operator: 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 13, 2025.

John Landry: 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 13 2025.

Olivier Taelman: With that, I will now turn the call over to Olivier. Thank you, John. Good day everyone and thank you for joining us for fourth quarter and full year 2024 earnings. 2024 was a transformative year for Nyxoah. With tremendous progress made throughout the year, we are extremely well positioned to bring Genio to market in the US by the end of this month. We have proven that Genio can deliver best-in-class outcomes for obstructive sleep apnea patients. or 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 70.8%.

Olivier: That will I will now turn the call over to Olivier.

Olivier: Thank you John.

Olivier: Good day, everyone and thank you for joining us for fourth quarter and full year 2024 earnings call.

Olivier: 2024th order comps formative year for Nicola.

Olivier: Tremendous progress made throughout the year, we are extremely well positioned to bring <unk> to market in the U S. By the end of this month.

Olivier: We have proven that GTO can deliver best in class outcomes for obstructive sleep apnea patients.

Olivier: Pivotal study dream met both its primary and secondary endpoints.

Olivier: The Dream study demonstrated a strong HIV sponsor it.

Olivier: 63, 5%.

Olivier: And in all the items on the rate of 71, 3% with an overall median.

Olivier: <unk> deduction of 78%.

Olivier Taelman: Importantly, through the study, we demonstrated that Genio is the only therapy with explicit clinical evidence-based data proving its ability to maintain its efficacy irrespective of a patient's sleeping position. This is a critical differentiator as people sleep on average between 35-40% 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. Genium 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 a minimum of 60 minutes of supine sleep time, on average, all subjects slept 114 minutes in a supine position.

Olivier: Importantly through this study we demonstrated that <unk> is the only therapy with explicit clinical evidence based data proving its ability to maintain its efficacy irrespective of a patients sleeping position.

Olivier: This is a critical differentiator as people sleep on average between 35% to 40% of the night on their back and.

Olivier: And based on published data the number of times before that a patient stops bleeding can double while in a supine position.

Speaker Change: <unk> Standalone with clinical trial data, specifically validating disclaim make.

Speaker Change: Making it the most consistently effective solution for patients.

Speaker Change: The entire night of their sleep.

Speaker Change: While our dream study uniquely required minimum.

Speaker Change: 60 minutes of Supine sleep time.

Speaker Change: Average all subject flipped one almost 40 minutes in a supine position.

Olivier Taelman: The study measured position-specific outcomes and demonstrated a 66.6% median HI reduction while sleeping in a supine position, 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 Genio the most effective solution for patients throughout the entire night of sleep. unlike competing technologies where supine sleep efficacy data have not been disclosed. Additionally, ONDREAM data revealed another significant clinical advancement. Genio produces a remarkable percentage of what we refer to as super responders.

Speaker Change: The study measures positional specific outcomes and demonstrated a 60 667 medium HIV deduction, while sleeping in a supine position despite.

Speaker Change: Despite the fact that the number of airway obstruction can double in disposition.

Speaker Change: This reduction compared favorably to the 71% median reduction shown while sleeping in a non supine position.

Speaker Change: This consistent efficacy across sleep position make gino the most effective solution for patients.

Michael Steib: The entire Michael Steib.

Michael Steib: Unlike competing technologies like supine sleep efficacy data has not been disclosed.

Michael Steib: Additionally, on real data is the most significant clinical advantage.

Speaker Change: <unk> could uses a remarkable sandwich or what we refer to as Super responders.

Olivier Taelman: patients whose AHI score is dropping below 15. effectively returning their mortality and cardiovascular risk to levels comparable to individuals not suffering from OSA. 82% of all DREAM 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 supraresponder data makes Genio a differentiated and unique solution for patients with OSA. In addition to these strong efficacy results, Genio also demonstrated a favorable safety profile with an 8.7% severe adverse event rate. 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.

Speaker Change: Patients, whose hei scopes is dropping below $50 <unk>.

Speaker Change: Effectively returning that market reality, and cardiovascular risks to levels comparable to individuals not suffering from overseas.

Speaker Change: 82% of all Green subjects achieved this results.

Speaker Change: This represents a profound clinical impact that goes beyond symptom management, two potentially extending patients' lives.

Speaker Change: The combination of the supine and Super Responder data makes Gino a dislocated and unique solution for patients with OSA.

Speaker Change: In addition to the strong efficacy results Jenny will.

Speaker Change: Also demonstrated a favorable safety profile with an eight 7% severe adverse event rate.

Speaker Change: 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 Ags solution.

Olivier Taelman: 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 Nyxoah. Based on our current interactions with FDA, where the focus is now on labelling, We continue to expect to receive FDA approval by the end of March of 2025.

Speaker Change: Let me now switch to the regulatory perspective.

Speaker Change: We have submitted the final module of our PMA submission in June 24.

Speaker Change: We continue to have a very interactive dialogue with the FDA and have successfully completed the remaining requirements.

Speaker Change: Including this Belgium site visits which has previously been delayed due to circumstances related to next door.

Speaker Change: Based on our interactions with FDA.

Speaker Change: The focus is more on labeling.

Speaker Change: We continue to expect to receive FDA approval by the end of March of 2025.

Olivier Taelman: In preparation for 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. 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.-based senior management team, including hiring John Landy as Chief Financial Officer, Dr. 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 US.

Speaker Change: In preparation for 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.

Speaker Change: Notably I moved with the family to the U S to be underground during this critical period.

Speaker Change: In addition, we have built a U S based senior management team include including hiring John Lambiase, Chief Financial Officer Dr.

Speaker Change: Dr Mortgage bonus Chief Medical officer, and scope Holstein as Chief commercial officer.

Speaker Change: In addition, we have industry, leading talent in place with a track record in OSA.

Speaker Change: Neuromodulation, a causal sales marketing reimbursement and medical affairs teams in the U S.

Olivier Taelman: Our strategy for penetrating the U.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 InBland4OSA and whose physicians have been eagerly awaiting a compelling alternative to offer them. Importantly, as a result of our clinical trials in the U.S., there are already 75,000 new Physicians that have been trained on the genial technology and are familiar with its unique features and patient outcomes Second, through focused commercial investments, we will develop strong referral networks with sleep physicians who manage a large population of moderate to severe OSA patients where AGNF is not yet fully embedded in their treatment pathway.

Speaker Change: Our strategy for penetrating the U S market.

Speaker Change: Vaults around two pronged approaches.

Speaker Change: As a small follow ups, we will target high volume Ags implanting centers with physicians and patients.

Speaker Change: Actively seeking an alternative solution to current therapy.

Speaker Change: In addition to these patients we have also identified significant demand from patients who are hesitant about receiving a pacemaker like in blanks of OSA and.

Speaker Change: And whose physicians have been eagerly awaiting a compelling alternative to offer them.

Speaker Change: Importantly, as a result of our clinical trials in the U S.

Speaker Change: We're already 75.

Speaker Change: Physicians that have been trained on the Geneva technology and are familiar with its unique features and patient outcomes.

Speaker Change: Second through focused commercial investments, we will develop strong referral networks with sleep physicians, who manage large populations of moderate to severe OSA patients, where <unk> is not yet fully embedded in their treatment pathway.

Olivier Taelman: As a company that prioritizes 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 putting the patients first. We plan to launch in the US 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.

Speaker Change: As a company that prioritize clinical evidence and patient outcomes.

Speaker Change: Simplified marketing messages.

Speaker Change: We believe and setting realistic expectations and partnering with physicians to find the optimal treatment for each patient.

Speaker Change: This is part of our mission and putting the patient swaps.

Speaker Change: We plan to launch in the U S. With 50 commercial team members comprising sales marketing and market access professionals, who are currently all highest and trade.

Speaker Change: With plans to scale quarter after quarter.

Speaker Change: This deal will be supported by focused direct to consumer initiatives.

Speaker Change: <unk> dedicated reimbursement support.

Speaker Change: Regarding reimbursement.

Speaker Change: We have identified and established CPT code that we plan to utilize at launch with.

Olivier Taelman: 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. We expect this will allow us to align on pricing while we are 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 Genio on the impact it can have on their patients. While our primary focus as a company has been on preparing for a U.S.

Speaker Change: The CPT code to be very precise is 64568.

This CPT code has been recognized by commercial and government payers for OSA indication and has the same CPT code useful the current FDA approved Ags technology.

Speaker Change: We expect this will allow us to align on pricing, while we will differentiating <unk> unique technology and clinical outcomes.

Speaker Change: 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 payer on GTO on the impact it can have on those patients.

Speaker Change: While our primary focus as a company has been on preparing for the U S. Launch we also continue to.

Olivier Taelman: launch, we also continue to be encouraged by our growth and what we learned in Europe. 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.

Speaker Change: To be encouraged by our growth and what we learned in Europe.

Speaker Change: Our commercial proof of concept in Germany has provided valuable insights that we are actively incorporating into our U S launch strategy.

Speaker Change: Our growth in Europe was primarily driven by the continued execution of our commercial strategy in Germany.

John Landry: As John will detail in his remarks, we are now recording a portion of our disposable patch revenue as deferred revenue. Our revenue would have been $1.9 million in the fourth quarter of 2024, excluding the impact of this deferral. This represents a 46% sequential growth. over Q3 2024.

Speaker Change: As John will detail in his remarks.

Speaker Change: We are now recording a portion of of disposable revenue is deferred revenue.

Speaker Change: Revenue would've been $1 9 million in the fourth quarter of 24%, excluding the impact of Disney follow this.

Speaker Change: This represents a 46% sequential growth.

Speaker Change: Over Q3 2024.

John Landry: For the full year, we have delivered revenue of 5.1 million euros 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. The Genio system is covered under the NHS Specialised Service Device Programme, 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 for Genio in the UK. We look forward to further expanding into other hospitals across the country and scaling our sales force.

Speaker Change: For the full year, we delivered revenue of $5 1 million euros.

Speaker Change: On an <unk> 18 increase at 18% increase over 2023.

Speaker Change: We have also continued to expand our geographic footprint in the region.

Speaker Change: In December we launched <unk> in the United Kingdom.

Speaker Change: The <unk> system is governed under the NHS specialized service device program, which makes us believe that the UK has the potential to become one of our largest international market.

Speaker Change: Based on the FERC successful implants at University College, London hospitals.

Speaker Change: There was a lot of excitement created from <unk> in the U K.

Speaker Change: We look forward to further expanding into other hospitals across the country and scaling our sales force.

Olivier Taelman: 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 Genio was the first AGNS implant performed in the Middle East.

Speaker Change: In addition, we have launched in the United Arab Emirates with the first commercial implant them in Dubai, Jordan Saudi Hospital.

This represents a unique milestone as geno was the first Ags implants performed in the Middle East.

Olivier Taelman: 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 genial solution. Both we and the clinical community are incredibly excited about what the rest of 2025 has in store.

Speaker Change: Collectively all of our accomplishments in 2020 for borders at this point.

Speaker Change: Now on the verge of bringing a truly innovative OSA solution to the U S market, where there is still exist the massive patient population in need of treatment that can benefit from a general solution.

Speaker Change: Both we and the climate and the clinical community are incredibly excited about what the rest of 2025 is installed.

John Landry: With that, I'll turn the call over to our CFO, John Landry, for a financial update. Thank you, Olivier. As Olivier mentioned in his earlier remarks, we deferred revenue related to disposable patches in the fourth quarter of 2024. As part of our contracts with customers, we deliver additional disposable patches on top of those included in the initial delivery of a GENIOS system. Beginning in the fourth quarter, the portion of the selling price for a GENIOS 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.

Speaker Change: With that I'll turn the call over to our CFO, John Landry from a financial update.

Thank you Olivier as Olivier mentioned in his earlier remarks, we deferred revenue related to disposable patches in the fourth quarter of 2024 as part of our contracts with customers. We deliver additional disposable patches on top of those included in the initial delivery of Virginia system, beginning in the fourth quarter the Porsche.

Speaker Change: One of the selling price for our <unk> system related to these additional disposable patches will be recognized as deferred revenue as deferred revenue will be recognized as revenue over time as the disposable patches are delivered to the customer.

John Landry: We recorded deferred revenue of €600,000 in the fourth quarter of 2024. Recognized revenue is €1.3 million in the fourth quarter and €4.5 million for the full year 2024.

Speaker Change: We recorded deferred revenue of 600000 euros in the fourth quarter of 2020 for recognized revenue was $1 3 million euro in the fourth quarter and $4 5 million Euro for the full year 2024.

John Landry: Total operating loss for the fourth quarter of 2024 was €18.3 million versus €10.8 million in the fourth quarter of 2023, driven by the acceleration in the company's R&D spending, ongoing commercial and clinical activities, and an acceleration in commercial investments in the U.S. Cash position remains strong at 85.6 million euros at December 31, 2024, compared to 57.7 million at the end of 2023. This includes proceeds from our 24.6 million euro 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.

Speaker Change: Total operating loss for the fourth quarter of 2024 was $18 3 million euro versus $10 8 million in the fourth quarter of 2023.

Speaker Change: Driven by the acceleration in the company's R&D spending ongoing commercial and clinical activities and an acceleration in commercial investments in the U S.

Our cash position remains strong at $85 6 million euros at December 31, 2024, compared to $57 7 million at the end of 2023.

Speaker Change: This includes proceeds from our $24 6 million Euro ATM equity raise early in the fourth quarter and reflect our disciplined approach to managing cash burn as we prepare for FDA approval and U S. <unk>.

Olivier Taelman: With that, I'd now like to hand the call back to Olivier to discuss his thoughts on 2025. Olivier? Thank you.

Speaker Change: With that I'd now like to hand, the call back to discuss his thoughts on 2025.

Speaker Change: Thank you.

Olivier Taelman: Before we conclude, I want to emphasise that this is a truly an exciting time for Nyxoah. With all of the fantastic work by our organisation during 24, we are incredibly well positioned for the future. Looking ahead to 2026, the US will be our key focus. 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 end of 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 AGNS technology.

Speaker Change: Before we close.

Speaker Change: I want to emphasize that this is truly an exciting time for <unk> with all of the syntax.

Speaker Change: Our organization during 2004.

Speaker Change: We are incredibly well positioned for the future.

Speaker Change: Looking ahead to 2020, the U S will be our key focus.

Speaker Change: From our current interaction with it where.

Speaker Change: Where the focus is now on labeling we continue to expect to receive FDA approval later this month.

Speaker Change: By the end of March in 2075.

Speaker Change: We have been able to identify a CPT code well known by payoffs in the OSA indication, which will allow us to establish competitive pricing compared to the current FDA approved <unk> technology.

Olivier Taelman: Second, we hired and trained a 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 AGNS sites in combination with focused commercial investments in developing referral networks for sleep physicians who manage large populations of OSA patients. Our success will be measured in entering these new accounts. and driving new patients to Genio coming from this referral network. ultimately resulting in market share gains. Lastly, in international markets, we will further increase genius penetration within Germany, but also within the UK. And we will selectively expand into new targeted international geographies, such as the UAE.

Speaker Change: Second.

We hired and trained the U S commercial team that is ready to launch upon FDA approval.

Speaker Change: With a two pronged strategy.

Speaker Change: Acting as a small follow up focused on high volume <unk> sites in combination with the focused commercial investments in developing the referral networks for sleep physicians, who manage large population of OSA patients.

Speaker Change: Our success will be measured in entering these new accounts.

Speaker Change: And driving new patients to <unk> coming from this deferral metabolic.

Speaker Change: Ultimately, resulting in market share gains.

Speaker Change: Lastly in international markets, we will further increase genius penetration within Germany, but also within the U K.

Speaker Change: We'll selectively expand into new targeted international geographies such.

Speaker Change: Such as the UAE.

Olivier Taelman: 2025 will be a transformative year in Nyxoah's growth as we make significant progress towards our mission of making sleep simple by bringing the GenioSolution to OSA patients in the U.S. and further expand into the mesh.

Speaker Change: 2025 will be a transformative year in <unk> growth as we make significant progress towards our mission of making sleep symbol by.

Speaker Change: By bringing the <unk> solution to OSA patients in the U S and.

Speaker Change: And further expand internationally.

Operator: With that, I would now like to open the lines for Q&A. Thank you. Ladies and gentlemen, as a reminder to ask a question, please press star 1-1 on your telephone, then wait for your name to be announced.

Speaker Change: With that I would know like to open the lines for Q&A.

Les: Thank you Les.

Les: Ladies and gentlemen, as a reminder to ask a question. Please.

Les: Please press star one on your telephone and wait for your name to be announced.

Operator: to withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster.

Draw. Your question. Please press star one again.

Les: Please stand by while we compile the Q&A roster.

Adam Maeder: Our first question comes from the line of Adam Maeder with Piper Sandler. Your line is open. Hi, good morning, Olivier and John, thank you for taking the questions and great to hear you still expect approval here. You know, by the end of the month, a lot of different questions that I could ask here, but maybe just to start on, you know, reimbursement, the new update there, you said you're gonna use the 64568 code. You know, there is some investor consternation that that level of reimbursement associated with the Hypoglossal Nerve Stimulation, you know, in particular to the physician.

Speaker Change: Our first question comes from the line of Adam <unk> with Piper Sandler Your line is open.

Adam: Hi, Good morning, Olivier and John Thank you for taking the questions and great to hear you still expect approval here.

Speaker Change: By the end of the month.

Speaker Change: A lot of different questions that I could ask here, but maybe just to start.

Speaker Change: On.

Speaker Change: Reimbursement the new update there you said you're going to use the 64568 code.

Speaker Change: There is some investor consternation that that level of reimbursement associated with that code is not overly attractive are sufficient for.

Hypoglossal nerve stimulation in particular to the physician so.

Olivier Taelman: So You know, what's your response to that? And do you believe this coding strategy is sufficient to drive strong update of Genio? And then at a follow-up. Thank you, Adam.

Speaker Change: What's your response to that and do you believe this coding strategy is sufficient to drive strong uptake of <unk> and then had a follow up thanks.

Olivier Taelman: So first of all, I do agree with you that for a physician's fee perspective, this is not the strongest code. On the other hand, if you look at Nyxoah, 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 a code because I realized that this was one of the open topics in our preparation for US launch. Now, on the other hand, I do think there is still a lot of work that needs to be done in this coding and also reflecting a stronger pricing and making it even more attractive for physicians.

Speaker Change: Thank you Adam So first of all.

Speaker Change: I do agree with you that for a physician's fee perspective. This is not the strongest growth on the other hand, if youll get next door.

Speaker Change: We will enter the market I think it's so important for us to be able to enter having directly a CPT code that generally presents payments technology. So from <unk> perspective, we are extremely pleased that we have identified the code because I realize that this was one of the open topics in preparation for U S launch.

Speaker Change: The other hand, I do think there is still a little slow and that needs to be done in this coding and also reflecting our strongest pricing and making it more attractive for physicians.

Olivier Taelman: Last, what I would like to comment on this, we will also explore in order to optimize the uniqueness of Genio 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 current AGNS technology that is available and the Genio technology that will be available. understood, and a really helpful color there.

Speaker Change: <unk>, what I would like to comment on this we will also explore in order to optimize the uniqueness of Juno and the technology offering a bilateral stimulation compared to the unit level simulation. So that we can maybe make it even more attractive linked to oil.

Speaker Change: Product differentiation.

As a summary, we are happy that we aggregate and we also would like to point out that the code is the same sort of position for both the existing the current Ags technology that is available and the new technology that will be available.

Michael Steib: Understood and really helpful color, thanks for that Olivier.

Adam Maeder: Thanks for that, Olivier. For the follow-up, you know, maybe just one on how you're thinking about, you know, the trajectory of U.S. launch. I'll ask the question kind of this way. So, I think I heard you mention 75 docs. I think those are U.S. docs, are trained on the Genio technology already. You know, how do we think about the pace of new account openings this year? I know the strategy is, you know, concentrated deep, not wide. But just, you know, is there a target number in mind for 2025? Just help us understand the strategy there.

Speaker Change: For the follow up maybe just one on how youre thinking about the trajectory of U S launch I'll ask the question. This way. So I think I heard you mentioned 75 docs I think those are U S. Stocks are trained on the GTO technology already.

Michael Steib: Yeah.

Michael Steib: How do we think about the pace of new account openings.

Michael Steib: This year I know the strategy is concentrated deep not.

Michael Steib: Wide.

Michael Steib: But just is there a target number.

Michael Steib: In mind for 2025, just help us understand.

Olivier Taelman: Thank you. So, 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 the usability study we did. And I think what was enormously rewarding for us was hearing that all physicians are actively asking and reaching out when we'll be available, and that they want to have Genio 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.

Michael Steib: The strategy there. Thank you.

So first of all of them were talking about 75, it's a little bit more than 70 sites. All physicians was part of the clinical study dream access and also the usability study we did.

I think what was it.

Michael Steib: <unk> for US was hearing that all physicians are actively asking at each node when he will be available and that they want to have some new integrated in bulk to treat OSA patients. That's the first step.

Michael Steib: Second one is as I mentioned, we have had.

Noelle: The sales team that is currently fully trained and ready to launch so noelle we approach this.

Olivier Taelman: So now, how will we approach this? Remember that the current AG&S business is very concentrated with roughly 300 to 350 sites, representing, let's say, 70 to 75% of total Asian-esque avenue. So those will be the targeted accounts, the 300 to 350. 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. So our first challenge will be, let's get the first physician trained, then we start expanding quarter after quarter.

Michael Steib: Remember that.

Michael Steib: Ags business is fairly concentrated with.

Roughly.

Michael Steib: Pre owned up to 250 sites.

Michael Steib: Resulting let's say, 70% to 75% of total Ags revenue. So those will be the targeted accounts to 300 to 350 with 50 people. We will stop we will train and educate surgeons of the quarters, we will scale up and we also have a playbook for scalability.

Speaker Change: Additional sales reps quota quality so of challenge will be.

Speaker Change: The first physician strength than we saw the following quote last quarters and I do think that in the period.

Adam Maeder: And I do think that in a period of 12 to 18 months, we will be able to cover all those tier 1 high volume Asian-esque accounts. Very helpful. Thank you.

Speaker Change: To 18 months, we will be able to cover all those volume comps.

Speaker Change: Very helpful. Thank you.

Speaker Change: Thank you.

Operator: Please stand by for our next question.

Speaker Change: Please standby for our next question.

Speaker Change: Okay.

John Block: Our next question comes from the line of John Block with Stiefel. Your line is open. Great. Thanks, guys, and good morning. Olivier, it seems like the dialogue with the FDA, you know, I've heard your comments, has been consistent and thorough. You know, however, just when I look at the calendar, the end of 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 end of March. And then maybe even more importantly, you know, what are your thoughts for the label?

Our next question comes from the line of Jon Block with Stifel. Your line is open.

Speaker Change: Great. Thanks, guys and good morning.

Speaker Change: I'll, let me in terms of the dialogue with the FDA.

Speaker Change: Part of your comments has been consistent and thorough.

Speaker Change: However, when I look at the calendar of the end of March was relatively soon we hear about all these cards 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 the small the end of March and then maybe even more importantly.

What are your thoughts for the label because again it seems like you are in the final stages your thoughts for the label and the likelihood that supine claims that you talked about are included.

John Block: 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, and then I'll ask my follow up.

Speaker Change: Upon approval and then I'll ask my follow up thanks.

Olivier Taelman: Thank you John for the question and first of all indeed it has been very challenging times for government and lately. Now 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 changements that are impacting the government procedures so that is already one step so from that end we are still good. 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.

John Landry: Well. Thank you John for the question and first of all indeed, it has been very challenging times for government them.

Speaker Change: Lately, though.

Speaker Change: When it comes to over file in the EU I am pleased that stays very carefully, but I'm, saying that I'm pleased that so far we have not seen any negative impact of the ongoing political changes that are.

Speaker Change: Impacting the government. So that is already one step so on balance we are still good though over the last two weeks. It has been extremely interacted with the FDA going back in for closing and announcing the last questions and also entering the labeling discussion.

Olivier Taelman: Now 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 90-day clock and the 90-day clock is ending of this month so that's why I was still confident with no changes in our review but 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 and that is also the part that we present to FDA.

Speaker Change: So when you talk about timing and while we still feel confident by the end of this month I think I mentioned earlier that there is something like a 90 day clock and the 90 day clock is ending.

Speaker Change: Look this month, so thats why we are still confident with no changes in our view that in the last stage with a labeling discussion and also loan that the clock is ticking that it make sense to still say that we expect to have an approval by the end of this month that is hopefully also in the first of all of the questions for the second one more specific.

Speaker Change: Owned enabling.

Speaker Change: It is clear that we would like to US also do uniqueness with office to find data being reflected in the label and that is also the Basel III designs to SBA is also has to be clear that with our existing clinical evidence of <unk>.

Olivier Taelman: It also has to be clear that with our existing clinical evidence on CCC patients and also the work that we are seeing in the US in excess study that we also do not see any reason to have CCC as a contraindication as compared to the current available AGMS technology that has CCC as a contraindication.

Patients and also the work that we will see in the U S and access study, but we also do not see any reason to the FCC as a contra indication as compares to.

Speaker Change: Available AG has technology that CCC ethical clarification, we do feel strong that this will not be the case, but maybe conclusion I would not want to jump to any conclusions until FDA made up its final months, but in a global discussion to answer your questions because of two things, let's vioxx publicly discuss.

Olivier Taelman: 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 That was great. That was great, Collar. Thank you.

Speaker Change: Got it.

Speaker Change: That was great. That's 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.

John Block: 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? Do you feel confident you have, you know, 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 Yeah, so I 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 AG&S and sometimes it's nice to be second.

Speaker Change: On that ramp or on the trajectory how do we think about the commercial payers coming on board do you feel confident you have at least one here in 2025 do you have a handful.

Speaker Change: And do you need some of these studies peer reviewed to help sort of stimulate or move that process forward. Thank you.

Speaker Change: Yes, so I first of all as I mentioned, there is already a couple of times of competitor has done a terrific job educating commercial payors about the benefits of Ags and sometimes it's nice to be second lien.

John Block: 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. We do think it's very realistic to expect the first commercial payers. during Q3-Q4 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 beginning. Thanks, guys. Thank you, John.

Speaker Change: I can only I compliment and applaud this more when it comes to us toward strategy also here, we will work with Preauthorizations, we will ask already patients lined up under the last low SKU authorizations in place the moment, we have FDA approval and moving forward.

Speaker Change: We do think started is realistic to expect the first commercial phase.

Speaker Change: During quarter three quarter four this year and of course, <unk> with government payers like CMS Medicare revenue, we do expect loss statements right from the beginning.

Speaker Change: Thanks, guys.

John Landry: Thank you John.

Operator: Please stand by for our next question.

Speaker Change: Please standby for our next question.

Matthew Park: Our next question comes from Milana Ross Osborn with Canna Fitzgerald. Your line is open. 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? Thank you for the question. 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.

Speaker Change: Our next question comes from the line of Ross <unk> with Cantor Fitzgerald. Your line is open.

Speaker Change: Hey, guys. This is Matthew park on for US today. Thanks for taking the questions I guess just to start off can you walk us through any manufacturing supply chain.

Speaker Change: That you guys currently have in place and.

Speaker Change: And do you think it is sufficient to meet existing demand upon approval.

Speaker Change: Yes.

Speaker Change: Thank you for the question.

Speaker Change: You're pointing at such an important such an important question I mean this is what every company wants to US when you launch you need to make sure the U S border and elasticity sufficient manufacturing.

Olivier Taelman: So also for Nyxoah, this is one of our key points. The team has worked so hard, and I'm happy to say that also there, we feel really confident.

Speaker Change: Inventory available. So also horses. So what does this vulnerable coupons of the E. Ms Russell <unk>.

Speaker Change: I'm happy to say that also there we still need the confidence.

Olivier Taelman: One more topic. What I also would like to point out is we are manufacturing products for the US market also in the US. 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.S. for the U.S., also being part of our U.S. focus as a company that we have. Got it, that's super helpful.

Speaker Change: One more topic.

I also would like to pull in orders that we are manufacturing.

Speaker Change: For the U S market also in the U S.

Speaker Change: This was a decision that was made already.

Speaker Change: A few years ago, I think IC and 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 and dancing around the globe. It is manufactured in the U S for the U S also being part of a U S focus as a company as we will have it.

Speaker Change: Got it that's Super helpful. And then just one more from me.

Matthew Park: 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?

Speaker Change: Kind of a bounce off of what John was getting on earlier.

Speaker Change: Would you just do you anticipate needing any real world data upon approval and would any potential timelines look like there to drive incremental adoption. Thanks for taking my question.

Matthew Park: Thanks for taking the question.

Olivier Taelman: My apologies, but you were not clear in the first part of the question, we had a bad line. Can you please repeat? Yes. Do you anticipate needing to generate any real-world data upon approval, and what would any potential timelines for this look like? Yes, yes, you know, yes. Yes, I think, you know, we'll probably continue.

Speaker Change: My apologies, but did the first you were not clear on the first part of the question that line can you can you. Please repeat.

Speaker Change: Yes.

Speaker Change: Would you do you anticipate needing to generate any real world data upon approval and while with any potential timeline for this look like.

Speaker Change: Yes, yes, yes.

John Landry: Yes, I think we'll probably continue as John here. So as we continue to go forward, we'll definitely want to collect real world data and real world experience. So we can better.

John Landry: This is John here. So as we continue to go forward, we'll definitely want to collect, you know, 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'll be an important part of our process in place. And I'm sorry, because it was difficult for me to understand the question, but of course, as part of the BMS post-market study approval, it is mandatory also to start collecting real-world data once we are launching. So yes, this is definitely an important part of our process. Got it.

John Landry: Articulate the clinical and economic justification of our technology. So as we go forward that will be an important part of our process.

John Landry: In place 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 has meant that we also to start collecting real world data once we have launches so yes definitely.

John Landry: The budget.

Matthew Park: That's super helpful. Thanks, guys. Thank you.

Speaker Change: Got it that's super helpful. Thanks, guys.

John Landry: Thank you.

Operator: Please stand by for our next question.

John Landry: Please standby for our next question.

Suraj Kalia: Our next question comes from the line of Suraj Kalia with Oppenheimer & Co. Your line is open. Hey, Olivier, John, congrats on all the progress. Can you hear me all right? Yes, I can. Perfect. Olivier, obviously you guys have had quite a bit of experience in Germany. As you'll prep for U.S. launch, the 75 or so docks that you'll are targeting Olivier, to the extent that the lessons learned from Germany... How do you think... What do you think is the key catch for Genio versus Inspire? Is it the supine versus non-supine? Is it bilateral? Is it just physicians looking to diversify?

Speaker Change: Our next question comes from the line of Suraj Kalia with Oppenheimer <unk> Company. Your line is open.

Thank you Olivier John Congrats on all the progress can you hear me alright, yes.

Yes, Hi, Kevin.

Speaker Change: Perfect.

Speaker Change: Obviously, you guys have had quite a bit of experience in Germany.

Speaker Change: As you prep for U S launch the 75 or so docs that you are targeting.

Speaker Change: To the extent that the lessons learned from Germany.

Speaker Change: How do you think.

What do you think is the key catch.

Speaker Change: Gene you versus inspire is it.

Speaker Change: Supine versus non supine isn't bilateral.

Speaker Change: Is it just physicians looking to diversify.

Suraj Kalia: Is it your CCC angle?

Speaker Change: Is it your CCC angle just help us understand where do you think the hook is going to be.

Olivier Taelman: Just help us understand where do you think the hook is gonna be for these quote-unquote initial low-hanging fruit of 75. 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. They also see the uniqueness with patients in order to upgrade their system without the need for a surgery, and also, of course, avoiding the risk I2 for another surgery for replacement of a battery.

Speaker Change: These quote unquote.

Speaker Change: Low hanging fruit of 75 physicians.

Yes.

Speaker Change: Yes, and thank you for this question.

Speaker Change: Going back to Germany and of initial learnings offering physicians and patients a choice in Ngls implants, and stepping away from an invasive space make solution into a single incision procedure has been key in the first introduction, whether it be with the technology.

Speaker Change: And of course, they explored further product differentiation they see the benefits from bilateral stimulation. They also see the uniqueness with patients in order to upgrade the system without the need for histology and also of course, avoiding the risk tool for automotive salvage Heath for replacement over.

Olivier Taelman: 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 components, 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 result that they'll see, including this, and to continue.

Speaker Change: Battery, but thats, what we saw initially.

Speaker Change: While we are further scaling in Germany alone, we're also seeing that physicians more and more.

Speaker Change: So I wanted to understand how important it is that patients are very compliant with this technology and also there we are seeing that with our variable components.

Creates a habit before you go to that having the available ready to get a good night's sleep X plus.

Speaker Change: The compliance rates, you're more than 85.

Speaker Change: This is also something that is driving this position next to the results of the oxy, including this to continue.

Suraj Kalia: Got it.

Speaker Change: Got it got it.

Suraj Kalia: 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?

Olivier: Follow up Olivier.

Speaker Change: Maybe I missed it did you.

Speaker Change: <unk> remarks, any update on timing of dream publication, and also status of enrollment and access gentlemen, Thank you for taking my questions.

Olivier Taelman: Gentlemen, thank you for taking my call. 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. I mean we cannot define how fast the review process is going but the submission has been done and we really expect to have it out definitely before 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-25 and then the next steps you as you know very well so it will be a PMA supplement and after this therefore we expect that we will have late 26 beginning 27 of potential labeling.

Speaker Change: Yes, and Thats an excellent question on did you mean publication. So submission has been made its global <unk> and we expect publication in a leading medical journal.

Speaker Change: We expect this publication in the coming months.

Speaker Change: We cannot define how fast that keep you posted as go into the submission has been done and that we really expect to have adults definitely baxalta.

Speaker Change: But when it comes to access.

Speaker Change: There are we continued to make good progress we will not disclose the precise number since we never did this but can we do expect to complete enrollment by mid 2000, and then the next steps you lost you know very well.

Speaker Change: BMA supplement an offshoot of this therefore.

Speaker Change: That was the last late 2006, beginning 2007, a potential label expansion.

Operator: Thank you.

Speaker Change: Thank you.

Operator: As a reminder, ladies and gentlemen, that's star 11 to ask the question.

Speaker Change: Thank you.

Speaker Change: As a reminder, ladies and gentlemen that star one to ask the question.

David Rescott: Please stand by for our next question.

Speaker Change: Please standby for our next question.

David Rescott: Our final question comes from the line of David Rescott with Baird. Your line is open. Oh, great. Thanks for taking the questions here. Olivier, I heard your comments on the, you know, what's given you confidence in the, you know, the March approval timeframe and the 90-day clock that you have.

Our final question comes from the line of David Ross Scott with Baird. Your line is open.

Speaker Change: Oh, great. Thanks for taking my questions here.

Speaker Change: Yes.

I heard.

Speaker Change: Your comments on the what's giving you confidence in the.

The March approval timeframe and then the 90 day clock do you have first I wanted to clarify thank you said.

David Rescott: 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 know, you have any events scheduled between now and April.

Speaker Change: <unk> site, because it did happen so I wanted to clarify that but second I'm not sure. If you have any events scheduled between now and April but let's say, we do get to April one and we haven't seen a press release at all from the team around approval.

Olivier Taelman: But let's say we do get to April 1st, and we, you know, haven't seen a press release at all from the team around approval, you know, 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, you know, essentially trying to help you get out in front of what could be a question, you know, arising in a couple weeks or so? Yeah, so first of all, David, we are still planning, as I was mentioning, to have really a press release out before the end of March based on the arguments I used.

Speaker Change: What would you maybe suspect naturally could've gone wrong, but could have been a cause maybe for you not to meet that that window, just essentially trying to help you get out in front of what could be a question of rising in a couple of weeks yourself.

Yeah. So first of all David we are still planning as I was mentioning to us really across cities beforehand. The launch based on the ultimate values.

Olivier Taelman: If we want to go completely in detail, there is something like a 10-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 end of March, we will have more communication coming out. 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 before April 1st with something.

Speaker Change: If we want to completely embedded in detail that is something like a 10 day Grace period.

Speaker Change: As that exist.

Speaker Change: No indication whatsoever.

Speaker Change: This would apply to us. So we are still we remain confident that before the end of March we will have more communication coming out.

Speaker Change: To your point, if we do not have any further news I think it's highly unlikely for Russell in conclusion, we remain confident that his address data that exists no indicators pointing in that direction. So short answer is I do expect that I will be back.

Speaker Change: For us.

That's helpful.

David Rescott: Okay, very helpful. Maybe on reimbursement, again, I heard the comments there already on the code that you plan on using, but, you know, from the commercial side, or sorry, from the, you know, 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, you know, Medicare reimbursed bucket versus those that could be potential, you know, patients when you expand the commercial coverage. And when you think about the progression of this rolling out essentially on day one, you know, do you have, I don't know if you'd call it confirmation, but do you have, you know, some, you know, visibility from CMS that they definitively, you know, will accept, you know, using that code for your device?

Speaker Change: Okay very helpful. And then maybe on on reimbursement again heard the comments there already on the code that you plan on using but.

Speaker Change: From the commercial side or sorry from the.

Speaker Change: Medicare kind of CMS Guide 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.

Speaker Change: Patients when you get 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.

Speaker Change: Some some visibility from CMS that they definitively.

Speaker Change: We will accept.

Speaker Change: Using that code for your device and do you expect maybe some.

David Rescott: And do you expect maybe some, you know, 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, you know, type of prior auth, you know, approval pathway for the system with this code? Or do you think, again, maybe there's some hurdles early on that pushes more of the, you know, ease of adoption and the reimbursement pathway more towards the second half of the year?

Speaker Change: Hurdles as you rollout in the early days around the maybe prior offs pathway to get those cover or do you think that pretty much for all of 2025, you should have a pretty similar.

Type of prior off approval pathway for <unk>.

Speaker Change: For the system with this code or do you think again, maybe there is some some hurdles early on that pushes more of them.

Speaker Change: Ease of adoption and the reimbursement pathway more towards the second half of the year. Thank you.

Olivier Taelman: Thank you. So, I do think we can state that roughly 20-30% Off-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 asked, and we are updating also the local MACs due to using the FDA Early Payer Program. Now, 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, you know, how fast the prioritization process is going, and who will be the first picking it up, but I hope you agree as well that when there is an established CPT code that they recognize for OSA payment, and since we fall under this code, if you look at the technicalities of our product, we do feel very confident that this will happen quite fast, and we continue working closely with the AIO on supporting us, and of course, the education through the Early Payer Program is definitely also helping us.

Speaker Change: So I do think we can state that roughly 20% to 30%.

All statements is done by Medicare specifically related to OSA patients also knowing the average age on.

Speaker Change: On the other hand, we know that there are local decisions that need to be made and then we also asked and we are updating also the local mix due to the using the SBA early payer program no.

Speaker Change: Do not have the full infill.

Speaker Change: Influence on whole staff thinks will go over I could not really comment in detail from a commercial payer perspective.

Speaker Change: Fast preauthorization processes, going and who will be the first picking it up but I hope you swallow that when there is an established CPT code.

Speaker Change: Recognize so OSA payments.

Speaker Change: Since the fall of the Scott if you look at technicalities product, we do offer steels added confidence.

Speaker Change: Still happened on quite quite soft.

Speaker Change: We continue working closely with the.

Speaker Change: On supporting US and of course, the education Kudos based program is also helping us.

David Rescott: Okay, thank you.

Speaker Change: Okay. Thank you.

Operator: Thank you. Will you stand by?

Speaker Change: Thank you.

Alana Paige Chamberlain: We do have another question in the queue. Our next question comes from Alana Paige Chamberlain with Wolf Research. Your line is open. Hi, good morning, guys. This is Paige on for Mike Polark. First question, on the code, CPT code 64568, the description we believe includes pulse generator. So that's obviously different than Henio form factor.

Speaker Change: Please standby we do have another question in the queue.

Speaker Change: Our next question comes from the line of pay Chamberlain with Wolfe Research. Your line is open.

Peter: Hi, Good morning, guys. This is Peter on for Mike Pollard.

Speaker Change: First question.

Peter: The code CPT code 645 and six.

Speaker Change: Description.

Speaker Change: <unk>.

Speaker Change: Pulse generator. So that's obviously different than any other form factor why are you guys confident that honeywell fits into that category.

Olivier Taelman: Why are you guys confident that Henio fits into this code category? 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 a pacemaker you have an internal pulse generator, and to your point, as you mentioned, very precise, the code comes from the pulse generator, and we do have one. Awesome, thank you.

Speaker Change: Because we do have a cult generated.

Speaker Change: Unique to.

Speaker Change: A battery and the only difference is that we have an external goes down the road.

Speaker Change: As mentioned, we have an internal thoughts gentlemen.

Speaker Change: One was you mentioned that the court has generated.

And we do have one.

Speaker Change: Awesome. Thank you.

Alana Paige Chamberlain: And then just one quick follow up on the deferred revenue recognition change.

Speaker Change: And then just one quick follow up on the deferred revenue recognition teams can.

John Landry: 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 the 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? Thank you so much. 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 we'll be deferring over time at this point. And that percentage will continue to decrease over time for a couple of reasons.

Can you guys help us understand what portion of our new patient implants will be deferred in the future and then.

Speaker Change: Does this mean that a patient needs to be compliant.

Speaker Change: Use the patch is over with.

Speaker Change: Period end is to be able to record the deferred revenue down the line. Thank you so much.

Speaker Change: Yes, Thank you page so.

Speaker Change: In terms of the percentage, it's a small percentage of the.

Speaker Change: The total selling price of the genome plant.

Speaker Change: Small percentage that will be deferring over time.

Speaker Change: At this point and that percentage will continue to decrease over time for a couple of reasons.

John Landry: If 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 the devices, and we ship the devices out to the patient. But there is no requirement for some sort of compliance metric similar to CPAP usage. Thank you.

Speaker Change: Cost and we ascribe value to disposable patches decrease that would reduce the amount of the deferral that we have going forward.

Speaker Change: And then in terms of compliance there is no specific compliance requirement associated with deferred revenues of the deferred revenue revenue will be recorded and recognized as revenue as the patient utilizes devices and we ship the devices out to patients, but there is no requirement or.

Speaker Change: Im sorry compliance metric similar to see that usage.

Thank you.

Operator: Ladies and gentlemen, I'm showing no further questions in the queue.

Speaker Change: Ladies and gentlemen, I'm showing no further questions in the queue.

Operator: That concludes today's conference call. Thank you for your participation. You may now disconnect.

Speaker Change: That concludes today's conference call. Thank you for your participation you may now disconnect.

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: Okay.

[music].

Speaker Change: Okay.

Speaker Change: [music].