Q2 2025 Nyxoah SA Earnings Call
Speaker #1: Hello, and welcome to Nyxoah's second quarter 2025 earnings conference call. At this time, all participants are in listen-only mode. After the speakers' presentation, there will be a question-and-answer session.
Pearson Dennis: Hello, and welcome to Nyxoah's second quarter 2025 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 a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 again. I will now like to turn the conference over to Pearson Dennis. You may begin.
Speaker #1: To ask a question during the session, you will need to press *11 on your telephone. You will then hear an automated message advising that your hand is raised.
Speaker #1: To withdraw your question, please press *1 again. I would now like to turn the conference over to Pearson Dennis. You may begin.
Speaker #2: Thank you. Good afternoon, everyone, and I welcome you to our second quarter 2025 earnings call. Participating from the company today will be Olivier Taelman, Chief Executive Officer, and John Landry, Chief Financial Officer.
Pearson Dennis: Thank you. Good afternoon, everyone, and I welcome you to our second quarter 2025 earnings call. Participating from the company today will be Olivier Taelman, Chief Executive Officer, and John Landry, Chief Financial Officer. During the call, we will discuss our operating activities and review our second quarter 2025 financial results released after U.S. market closing today, after which we will host a question and answer session. The press release can be found on the Investor Relations section of our website. This call is being recorded and will be archived in the events section on the Investor Relations tab of our website. Before we begin, I 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.
Speaker #2: During the call, we will discuss our operating activities and review our second quarter 2025 financial results released after U.S. market closing today. After which, we will host a question-and-answer session.
Speaker #2: 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.
Speaker #2: Before we begin, I'd like to remind you that any statements that relate to expectations or predictions of future events, market trends, results, or performance are forward-looking statements.
Speaker #2: All forward-looking statements are based upon our current estimates and various assumptions. These forward-looking statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements.
Pearson Dennis: These forward-looking statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. All forward-looking statements are based upon current available information, and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these forward-looking statements. For a list and description of our risks and uncertainties associated with our business, please refer to the risk factors section of our Form 20-F filed with the Securities and Exchange Commission on March 20, 2025. With that, I will now turn the call over to Olivier.
Speaker #2: All forward-looking statements are based upon currently available information, and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these forward-looking statements.
Speaker #2: For a list and description of our risks and uncertainties associated with our business, please refer to the risk factors section of our Form 20-F filed with the Securities and Exchange Commission on March 20, 2025.
Speaker #2: With that, I will now turn the call over to Olivier.
Speaker #3: Thank you, Pearson. Today, everyone, and thank you for joining us for our second quarter 2025 earnings call. I am extremely proud to announce that we received FDA PMA approval for our junior system in the United States.
Olivier Taelman: Thank you, Pearson. Good day, everyone, and thank you for joining us for our second quarter 2025 earning call. I am extremely proud to announce that we received FDA PMA approval for our Genio system in the U.S. This result was the culmination of persistent, strong regulatory and clinical execution supported by the entire passionate and committed Nyxoah team. For U.S. patients suffering from obstructive sleep apnea or OSA, the Genio system provides them with a significant advantage from currently available treatment options. For physicians, they now have a choice to select the optimal AGNS therapy for their patients. For Nyxoah, it marks the beginning of an exciting journey in the U.S. This PMA approval confirms the safety and effectiveness of our innovative technology and authorized commercial distribution in the U.S., which now has actively begun.
Speaker #3: This result was a determination of persistence, strong regulatory and clinical execution, supported by the entire passionate and committed Nyxoah team. For U.S. patients suffering from obstructive sleep apnea (OSA), the junior system provides them with a significant advance from currently available treatment options.
Speaker #3: For physicians, they now have a choice to select the optimal AGNS therapy for their patients. For Nyxoah, it's morally the beginning of an exciting journey in the U.S.
Speaker #3: This PMA approval confirms the safety and effectiveness of our innovative technology and authorizes commercial distribution in the U.S., with no activities begun. The junior system becomes the first and only bilateral AGNS therapy approved in the U.S.
Olivier Taelman: The Genio system becomes the first and only bilateral AGNS therapy approved in the U.S. for treatment of OSA. It is also important to note that the Genio system is not contraindicated for patients suffering from complete concentric collapse or CCC. Another key differentiator represented in our label highlights our ability to treat patients with positional OSA. This is important as, according to published data, a patient's AHI score can double when a patient sleeps in a supine position or on their back. Having this in our label serves as a validation of the clinical outcomes from our pivotal DREAM study, which met its primary endpoints regardless of a patient's sleep position.
Speaker #3: For the treatment of OSA, it's also important to note that the junior system is not contraindicated for patients suffering from complete concentric collapse, or CCC.
Speaker #3: Another key differentiator represented in our label highlights our ability to treat patients with positional OSA. This is important, as according to published data, a patient's AHI score can double when a patient sleeps in a supine position or on their back.
Speaker #3: Having this in our label serves as validation of the clinical outcomes from our pivotal DREAM study, which met its primary endpoints regardless of a patient's sleep position.
Speaker #3: Also note that complete concentric collapse (CCC) is not contraindicated, but is included as a warning in the company's label, as the safety and effectiveness for patients suffering from CCC have not yet been established for the junior system based on U.S.-specific clinical data.
Olivier Taelman: Also, note that complete concentric collapse or CCC is not contraindicated but is included as a warning in the company's label as the safety and effectiveness for patients suffering from CCC has not yet been established for the Genio system based on U.S.-specific clinical data. Our goal is, however, to make Genio available for U.S. patients suffering from CCC as soon as possible. Therefore, we strategically elected to stop enrollment in the ACCESS study. We believe that the number of patients enrolled in ACCESS will have enough statistical power to draw meaningful conclusions on our effectiveness for complete concentric collapse patients.
Speaker #3: Our goal is, however, to morally make junior available for U.S. patients suffering from CCC as soon as possible. Therefore, we strategically elected to stop enrollment in the access study.
Speaker #3: We believe that the number of patients enrolled in access will have enough statistical power to draw meaningful conclusions on our effectiveness for complete concentric collapse patients.
Speaker #3: In addition, we see great results in real-life data from patients in Europe, where our CE MORIC already includes an indication for CCC patients. I'm also pleased to report that our DREAM study was published by the Journal of Clinical Sleep Medicine, which is a leading journal for the sleep community.
Olivier Taelman: In addition, we see great results in real-life data from patients in Europe where our CE mark already includes an indication for CCC patients. I am also pleased to report that our DREAM study was published by the Journal of Clinical Sleep Medicine, which is a leading journal for the sleep community. I'd like to highlight a couple of data points that were published for the first time, which demonstrate a high level of patient satisfaction. The device demonstrated compliance of 85.9%, and the patient satisfaction was scored at 90%. This data confirms our early experience in Europe, and we believe the publication of the DREAM pivotal study will strengthen our U.S. launch and will also give us access to new international markets. Immediately upon receiving FDA approval, we started our focused U.S. launch with a commercial organization with over 50 highly talented and experienced professionals.
Speaker #3: I'd like to highlight a couple of data points that were published for the first time, which demonstrate a high level of patient satisfaction. The device demonstrated compliance of 85.9%, and patient satisfaction was scored at 90%.
Speaker #3: This data confirms our early experience in Europe, and we believe the publication of the Dream Study will strengthen our U.S. launch and will also give us access to new international markets.
Speaker #3: Immediately upon receiving FDA approval, we started our focused U.S. launch with a commercial organization of over 50,000 highly talented and experienced professionals. This team is now executing our two-pronged launch strategy.
Olivier Taelman: This team is now executing on our two-pronged launch strategy. They will target high-volume hypoglossal nerve stimulation implanting centers where they will position Genio system as a differentiated option for patients suffering from OSA, and they will focus on developing strong referral networks with sleep physicians managing large populations of moderate to severe OSA patients who quit CPAP but are in need for treatment. Our U.S. sales team is already actively engaging with these targeted sites, working through the value analysis committee and pre-authorization approval processes. From a launch execution perspective, I am very pleased to report that already in the first week, we received several VAC and pre-authorization approvals. It's also very exciting to see multiple physicians with patients lined up who are running quickly to become the first to implant Genio system commercially in the U.S.
Speaker #3: They will target high-volume hypoglossal nerve stimulation implanting centers, where they will position Genio as a differentiated option for patients suffering from OSA. They will focus on developing strong referral networks with sleep physicians managing large populations of moderate to severe OSA patients who have quit CPAP but are in need of treatment.
Speaker #3: Our U.S. sales team is already actively engaging with these targeted sites, working through the value analysis committee and prioritization approval processes. From a launch execution perspective, I am very pleased to report that, already in the first week, we received several VAC and prioritization approvals.
Speaker #3: It's also very exciting to see multiple physicians with patients lined up who are running quickly to become the first to implant Genio commercially in the U.S.
Speaker #3: Regarding reimbursement, we have identified the use of CPT codes 64 and 568, which have been recognized by commercial and government payers for the OSA indication.
Olivier Taelman: Regarding reimbursement, we have identified the use of CPT code 64568, which has been recognized by commercial and government payers for the OSA indication. This is the same CPT code used by our competitors, and we feel confident that we will be able to differentiate ourselves via our unique technology benefits and patient focus. As a result of our ongoing work with the American Academy of Otolaryngology and participation in the FDA's Early Payer Feedback Program educating CMS and major commercial payers on the clinical impact Genio system can have on their OSA patients, positions us well for acceptance of pre-authorization submissions in the near term and favorable coverage decisions in the long term. With over 100 physicians in the U.S. already trained and additionally weekly training sessions scheduled, there is strong momentum building in the medical community.
Speaker #3: This is the same CPT code used by our competitors, and we feel confident that we will be able to differentiate ourselves via our unique technology benefits and patient focus.
Speaker #3: As a result of our ongoing work with the American Academy of Otolaryngology and participation in the FDA's early payer feedback program, educating CMS and major commercial payers on the clinical impact Genio can have on their OSA patients, we are well positioned for acceptance of prioritization submissions in the near term and favorable coverage decisions in the long term.
Speaker #3: With over 100 physicians in the U.S. already trained and additional weekly training sessions scheduled, there is strong momentum building in the medical community. Our initial traction in the marketplace is demonstrated by the many physicians lining up patients for a Genio implant in just our first week of commercialization.
Olivier Taelman: Our initial traction in the marketplace is demonstrated by the many physicians lining up patients for a Genio system implant in just our first week of commercialization. This early interest gives us confidence in the success of our U.S. launch. We have also identified demand from patients who are hesitant about receiving an implanted battery, which requires the need for subsequent surgery to replace this battery. The Genio system addresses this need with its unique and less invasive design. There has recently been a lot of discussion on the potential impact of GLP-1 therapies on the AGNS market. Contrary to our competitors, we have strategically limited our patient population to those with a BMI below 32 since that is where the efficacy for Genio system is proven. As a result, we believe that the eligible Genio system patient population will grow, not shrink.
Speaker #3: This early interest gives us confidence in the success of our U.S. launch. We have also identified demand from patients who are hesitant about receiving an implanted battery, which requires the need for subsequent surgery to replace this battery.
Speaker #3: The junior system addresses this need with its unique and less invasive design. There has recently been a lot of discussion on the potential impact of GLP-1 on the AGNS market.
Speaker #3: Contrary to our competitors, we have strategically limited our patient populations to those with a BMI below 32, since that is where the efficacy for Genio is proven.
Speaker #3: As a result, we believe that the eligible Genio patient populations will grow, not shrink. This belief is based on Sermon study data showing GLP-1's ability to bring patients with high BMIs of 37 and above down to a BMI level where clinical data demonstrates that Genio is effective.
Olivier Taelman: This belief is based on several study data showing GLP-1 therapies' ability to bring patients with high BMIs of 37 and above down to a BMI level where clinical data demonstrates that Genio system is effective. Without GLP-1 therapies, we would never be able to treat this high BMI patient population. While there might be patients with lower BMIs dropping out of the potential AGNS patient population, this will be outweighed by a significant number who become eligible for AGNS. On another topic, prior to Genio system FDA approval, Inspire Medical initiated a patent lawsuit against Nyxoah. Since Nyxoah was founded, we have invested significantly in our IP portfolio, and we will vigorously defend ourselves in this matter and have the means to do so. This patent lawsuit will not impact our U.S. commercial launch, which is already underway and generating a lot of enthusiasm in the marketplace.
Speaker #3: Without GLP-1, we would never be able to treat this high BMI patient population. While there might be patients with lower BMIs dropping out of the potential AGNS patient population, this will be outweighed by significant numbers who become eligible for AGNS.
Speaker #3: On another topic, prior to Genio FDA approval, Inspire Medical initiated a patent lawsuit against Nyxoah. Since Nyxoah was founded, we have invested significantly in our IP portfolio, and we will vigorously defend ourselves in this matter. We have the means to do so.
Speaker #3: This patent lawsuit will not impact our U.S. commercial launch, which is already underway and generating a lot of enthusiasm in the marketplace. To conclude my opening remarks, I want to emphasize that the FDA approval marks a pivotal moment for Nyxoah.
Olivier Taelman: To conclude my opening remarks, I want to emphasize that the FDA approval marks a pivotal moment for Nyxoah. Our bilateral stimulation technology offers a truly differentiated solution that makes us unique for patients. We believe Genio system can fundamentally improve the quality of life for OSA patients by giving them a good night's sleep. With the current ongoing momentum and physicians already lining up patients for Genio system, we are confident in our ability to execute a successful U.S. launch. With that, I will turn the call over to our CFO, John Landry, for a financial update.
Speaker #3: Our bilateral stimulation technology offers a truly differentiated solution that makes us unique for patients. We believe Genio can fundamentally improve the quality of life for OSA patients by giving them a good night's sleep.
Speaker #3: With the current ongoing momentum and physicians already lining up patients for Genio, we are confident in our ability to execute a successful U.S. launch.
Speaker #3: With that, I'll turn the call over to our CFO, John Landry, for a financial update.
Speaker #4: Thank you, Olivier. We recorded revenue of €1.3 million in the second quarter of 2025, compared to €800,000 in the second quarter of 2024, for an increase of 73.8%.
John Landry: Thank you, Olivier. We recorded revenue of €1.3 million in the second quarter of 2025, compared to €800,000 in the second quarter of 2024 for an increase of 73.8%. Gross margin in the second quarter of 2025 was 63.4%, or essentially flat to the second quarter of 2024. Total operating loss for the second quarter of 2025 was €19.9 million versus €13.3 million in the second quarter of 2024. This was driven by the acceleration in the company's commercial investments in the U.S. in preparation for post-FDA commercial launch. Our cash position, including cash, cash equivalents, and financial assets, was €43 million at June 30, 2025, compared to €63 million at March 31, 2025. We also have €27.5 million available to us under our term debt facility, which can be drawn down in two equal tranches of €13.75 million each, which are subject to certain milestones.
Speaker #4: Gross margin in the second quarter of 2025 was 63.4%, or essentially flat to the second quarter of 2024. Total operating loss for the second quarter of 2025 was $19.9 million, compared to $13.3 million in the second quarter of 2024.
Speaker #4: This was driven by the acceleration in the company's commercial investments in the U.S. in preparation for the post-FDA commercial launch. Our cash position, including cash, cash equivalents, and financial assets, was €43 million at June 30, 2025, compared to €63 million at March 31, 2025.
Speaker #4: We also have €27.5 million available to us under our term debt facility, which can be drawn down in two equal tranches of €13.75 million each, which are subject to certain milestones.
Speaker #4: With that, I'd now like to hand the call back to Olivier to discuss his thoughts on the remainder of 2025. Olivier?
John Landry: With that, I'd now like to hand the call back to Olivier to discuss his thoughts on the remainder of 2025. Olivier?
Speaker #3: Thank you, John. Before we conclude, I want to emphasize that this FDA approval represents a truly historic move for Nyxoah. I would like to thank all Nyxoah employees for their persistence and effort in making this happen.
Olivier Taelman: Thank you, John. Before we conclude, I want to emphasize that this FDA approval represents a truly historic move for Nyxoah. I would like to thank all Nyxoah employees for their persistence and effort in making this happen. We have now officially entered the U.S. OSA market with our innovative Genio system, and the launch is actively ongoing. The enthusiastic response from physicians and their patients reinforces our confidence in the success of this U.S. launch. We believe the remainder of 2025 will be a transformative period as we establish Genio system in the U.S. market and advance our mission of making sleep simple for patients worldwide. We look forward to updating you on our progress on our next earning calls. With that, I would now like to open the line for question and answer.
Speaker #3: We have now officially entered the U.S. OSA market with our innovative Genio solution, and the launch is actively ongoing. The enthusiastic response from physicians and their patients reinforces our confidence in the success of this U.S. OSA market entry.
Speaker #3: We believe the remainder of 2025 will be a transformative period as we establish Genio in the U.S. market and advance our mission of making sleep simple for patients worldwide.
Speaker #3: We look forward to updating you on our progress on our next earnings call. With that, I would now like to open the line for questions and answers.
Speaker #1: Thank you. Ladies and gentlemen, as a reminder to ask a question, please press *11 on your telephone and then wait for your name to be announced.
Pearson Dennis: Thank you. Ladies and gentlemen, as a reminder to ask a question, please press star 1-1 on your telephone and then wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of John Block with CFIZ. Your line is open.
Speaker #1: Feel free to throw your question. Please press *11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of John Block with Steeple.
Speaker #1: Your line is open.
Speaker #5: Thank you. Hey, guys. Good afternoon. I'm Olivier and John, obviously a big congratulations to you and the team. I'll start off, just any year-end '25 metrics, you know, the leading indicators to focus on.
John Block: Thank you. Hey, guys. Good afternoon. Olivier and John, obviously, a big congratulations to you and the team. I will start off, just any year-end 2025 metrics, you know, images to focus on. Trained physicians, I do not know, I will throw that one out there, even though I know you said you already have, I think it was over 100. Can we be paying attention to that, the number of certified centers, the number of implants? I know it is early days, but just as we think about over the next three or four months, you know, where our eyes or where our focus should be as we think about exiting 2025 in regards to the Genio system launch. Thank you.
Speaker #5: Train physicians. I don't know, I'll throw that one out there. You know, I know you said you already have, I think it was over 100.
Speaker #5: Should we be paying attention to that—the number of certified centers, the number of implants? I know it's early days, but just as we think about over the next three or four months, where our eyes or where our focus should be as we think about exiting '25 in regards to the Genio launch.
Speaker #5: Thank you.
Speaker #4: Yep. Yeah, thanks for the question, John. In terms of some of the leading indicators that we're tracking, obviously we mentioned today the number of physicians trained. That's going to be something that we keep a close eye on, as that's obviously a leading indicator.
John Landry: Yep. Yeah, thanks for the question, John. In terms of some of the leading indicators that we're tracking, obviously, we mentioned today the number of physicians trained. That's going to be something that we keep a close eye on, as that's obviously a leading indicator. We'll also be looking at the number of value analysis committee applications that we submit to the various institutions over time, as that's also another leading indicator. I think over time, we'll be looking at some other metrics vis-à-vis maybe number of accounts opened or pre-authorization approvals received. However, at this point in time, we're still working through that, and we'll share more on our next quarterly call with all of you.
Speaker #4: We'll also be looking at the number of value analysis committee applications that we submit to the various institutions over time, as that's also another leading indicator.
Speaker #4: I think, over time, we'll be looking at some other metrics, such as the number of accounts opened or pre-authorization approvals received. However, at this point in time, we're still working through that, and we'll share more on our next quarterly call with all of you.
Speaker #5: Fair enough. Thanks for that. And then I'll sort of pivot. Olivier, this one might be for you, but just, you know, obviously there was the approval, but then there was also, I don't know, maybe call it like the favorable label that went along with the approval.
John Block: Fair enough. Thanks for that. I will sort of pivot. Olivier, this one might be for you, but just, you know, obviously, there was the approval, but then there was also, I do not know, maybe call it like the favorable label that went along with the approval. Can you talk about how you expect to leverage the differentiated label, you know, such as no CCC contraindication, the sleep positional data? You know, I know if it is more of a commercial question, if you would, but how do you expect to capitalize on that in the go-to-market when we think about over the next handful of quarters? Thank you.
Speaker #5: So, can you talk about how you expect to leverage the differentiated label? You know, such as no triple-C contraindication, the sleep positional data? I know it's more of a commercial question, if you would, but how do you expect to capitalize on that in the go-to-market when we think about over the next handful of quarters?
Speaker #5: Thank you.
Speaker #2: Thank you, John, for this
Olivier Taelman: Thank you, John, for this question as well. Yeah, clear, it was for us a bit important win to also see this differentiation reflected in the label. As our mission is always make sleep simple, and that starts also by being certain that we can protect patients throughout the entire night regardless in what sleep position they are. That is why positional OSA is so important that also there we can continue showing a highly effective technology and therapy. So far, Genio system is the only technology that is offering this. So that comes to the supine data and the positional OSA. When it comes to CCC, of course, there it is extremely encouraging to see that also FDA is recognizing this by not giving us a contraindication contrary to competition. As you know, with ACCESS, so there we also did great work.
Speaker #3: Yeah, clearly it was, for us, a bit important win to also see this differentiation reflected in the label. As our mission is always to make sleep simple, that starts also by being certain that we can protect patients throughout the entire night, regardless of what sleep position they are.
Speaker #3: And that is why positional OSA is so important. There, we can continue showing a highly effective technology and therapy, and so forth.
Speaker #3: Genio is the only technology that is offering this. So, that comes to the supine data and the positional OSA. When it comes to CCC, of course, it's extremely encouraging to see that the FDA is recognizing this by not giving us a contraindication, contrary to the competition.
Speaker #3: And as you know, with access, so there we also did great work. We had our PIs implanting a significant number, so now we can closely we can stop the enrollment earlier because also there we would like to advance on bringing this and making it available for CCC patients in the U.S.
Olivier Taelman: We had our PIs implanting a significant number. Now we can closely, we can stop the enrollment earlier because also there we would like to advance on bringing this and making it available for CCC patients in the U.S. So both are reflected in the label. I know that you and many of your colleagues have questions on this in the past. Again, it is confirming what we were telling you that bilateral stimulation is making a difference compared to unilateral stimulation and that this definitely will also help convincing physicians when they have to choose between the two available AGNS technologies.
Speaker #3: So both are reflected in the label. I know that you and many of your colleagues had questions on this in the past, and again, it is confirming what we were telling you: that bilateral stimulation is making a difference compared to unilateral stimulation.
Speaker #3: And that this definitely will also help in convincing physicians when they have to choose between the two available AGNS technologies.
Speaker #5: All right, great caller. Thanks. I've got more, but I'll hop back in the queue for now. Thanks, guys.
John Block: All right. Great caller. Thanks. I got more, but I will hop back in the queue for now. Thanks, guys. Thank you, John.
Speaker #3: Thank you, John.
Speaker #1: Please stand by for our next question. Our next question comes from the line of Adam Mater with Piper Sandler. Your line is open.
Pearson Dennis: Please stand by for our next question. Our next question comes from the line of Adam Maeder with Piper Sandler. Your line is open.
Speaker #4: This is Kyle on for Adam. Thanks for taking the questions, and we extend our congrats on FDA approval as well. Maybe just first to double-click a little bit on the commercial strategy that you discussed in your prepared remarks.
Kyle: This is Kyle on for Adam. Thanks for taking the questions, and we extend our congrats on FDA approval as well. Maybe just first to double-click a little bit on the commercial strategy that you discussed in your prepared remarks. I was hoping to get an idea of which accounts you are aiming to target first. Are they centers from the DREAM pivotal study, from the high-volume implanters? Could you just give us any color around the account and the strategy there? Thanks.
Speaker #4: I was hoping to get an idea of which accounts you're kind of aiming to target first. Are they, you know, kind of centers from the Dream Study?
Speaker #4: Some of the high-volume implantors? Could you just give us kind of any color around the accounts and the strategy there? Thanks.
Speaker #3: Yeah, no, no, definitely. So, as I mentioned in the script, we have a two-pronged approach. First of all, our sales team will focus on high-volume hypoglossal nerve stimulation implanting accounts.
Olivier Taelman: Yes, no, no, definitely. As I mentioned in the script, we have a two-pronged approach. First of all, our sales team will focus on high-volume hypoglossal nerve stimulation implanting accounts. As a quick reminder, in the U.S., there are roughly 1,400 implanting accounts offering AGNS, but it stays a very concentrated market, meaning that 350 to 400 of these are high-volume accounts and are representing 75% to 80% of the total revenue. Those are the accounts the team will be focused on. We start with a team of 50 commercial people, of which 25 are territory managers. They will all have four to six of these accounts. We have built what we call a scalable technology. Every quarter, we will add a number of territory managers and increase the number of accounts so that we can cover as soon as possible all 400 of those high-volume implanting accounts.
Speaker #3: Maybe as a quick reminder to this, you know that in the U.S. there are roughly 1,400 implanting accounts offering AGNS. But it stays a very concentrated market, meaning that 350 to 400 of these are high-volume accounts and are representing 75% to 80% of the total revenue.
Speaker #3: So, those are the accounts the team will be focused on. We start with a team of 50 commercial people, of which 25 are territory managers.
Speaker #3: They will all have four to six of these accounts, and we have built what we call a scalable technology. So every quarter, we will add a number of territory managers.
Speaker #3: Territory managers and increase the number of accounts so that we can cover, as soon as possible, all 400 of those high-volume implanting accounts. So that is what we call our focused launch.
Olivier Taelman: That is what we call our focused launch. Next, and I think as important, is also strengthening the referral paths. The way we are doing this at Nyxoah, it is totally different compared to the way it is done in the past, in the sense that we will focus on patients that have moderate to severe OSA and that are quitting CPAP. Also there, focusing on those specific patient groups will definitely strengthen the trust and confidence of sleep physicians and will also further make sure that patients in need for treatment will get a sleep surgeon that can help them with the Genio system solution. That is how we plan to go forward with our launch strategy.
Speaker #3: Next, and I think as important, is also strengthening the referral paths. The way we are doing this at Nyxoah is totally different compared to the way it was done in the past.
Speaker #3: In the sense that we will focus on patients who have moderate to severe OSA and who are quitting CPAP, focusing on these specific patient groups will definitely strengthen the trust and confidence of sleep physicians. It will also ensure that patients in need of treatment will be directed to a sleep surgeon who can help them with the Genio solution.
Speaker #3: So that's how we plan to go forward with our launch strategy.
Speaker #4: That's super helpful. Thanks for the color there. Maybe just for my second question, to shift over to reimbursement a little bit, is there a specific plan you have for going about that process here, looking forward?
Kyle: That's super helpful. Thanks. Thanks for the color there. Maybe just for my second question, to shift over to reimbursement a little bit. How do you plan to go about that process here looking forward? Are there any logistical considerations around the work that you're doing with the different payers? Then maybe more specifically, when can we expect to see some onboarding of some of the larger payers? Would it be fair by the end of this year, or is it kind of more of a 2026 story? Thanks again, guys.
Speaker #4: Are there any logistical considerations, you know, around the work that you're doing with the different payers? And then maybe more specifically, when can we expect to see some onboarding of some of the larger payers?
Speaker #4: Would it be fair by the end of this year, or is it kind of more of a 2026 story? Thanks again, guys.
Speaker #3: Yeah, thanks, Kyle. I can take.
John Landry: Yeah, thanks, Kyle. I can take this question. In terms of our reimbursement strategy, we have a comprehensive reimbursement strategy. We are using, as you may be aware, an established CPT code at launch. We are using the 64568 code. We have worked closely with the American Academy of Otolaryngology on that particular code. We have participated in the FDA's Early Payer Feedback Program. We have also been working with engaging CMS and major commercial payers in the U.S. around this particular code. As we work through this multifaceted approach and strategy, we expect these decisions will start coming in first for the pre-authorization. We would expect some of those to come in this year, clearly. I think we mentioned we had our first one now, but we expect more of those to come in over the balance of the year.
Speaker #4: this question. So in terms of our, you know, reimbursement strategy, we have a comprehensive reimbursement strategy. So we're using, as you may be aware, an established CPT code at launch.
Speaker #4: We're using the 64568 code. We've worked closely with the AAO on that particular code. We've participated in the FDA's early payer feedback program, and we've also been working on engaging CMS and major commercial payers in the U.S.
Speaker #4: Around this particular code, as we work through this multifaceted approach and strategy, we expect these decisions will start coming in first for the pre-authorizations.
Speaker #4: We'd expect some of those to come in this year, clearly. I think we mentioned we had our first one now, but we expect more of those to come in over the balance of the year.
Speaker #4: And then, as we start moving into more of the coverage decisions, if you will, that'll be probably more of a 2026 item, Kyle.
John Landry: As we start moving into more of the coverage decisions, if you will, that will be probably more of a 2026 item, Kyle.
Speaker #3: Perfect. Thank you.
Kyle: Perfect. Thank you.
Speaker #4: You're welcome.
John Landry: You're welcome.
Speaker #1: Please stand by for our next question. Our next question comes from the line of Suraj Khalil with Oppenheimer. Your line is open.
Pearson Dennis: Please stand by for our next question. Our next question comes from the line of Suraj Kalia with API Heimat. Your line is open.
Speaker #5: Hey, Olivier. It's John. Can you hear me all right?
Olivier Taelman: Hey, Olivier. John, can you hear me all right?
Speaker #3: Yes, we can. Hello, Suraj.
Olivier Taelman: Yes, we can. Hello, Suraj.
Speaker #5: Perfect. Gentlemen from Graphs and the approval, I know it's been a long time coming. And on the label, so Olivier, quick one, let me start out.
Olivier Taelman: Perfect. Gentlemen, congrats on the approval. I know it has been a long time coming and on the label. Olivier, a quick one. Let me start out. You mentioned ACCESS enrollment has been stopped. I presume the DSME chimed in and helped you all reach that decision?
Speaker #5: You mentioned access enrollment has been stopped. I presume that the SME chimed in and helped your groups with that decision?
Speaker #3: Yeah, so when it comes to the Access Study, in fact, we reached a significant number of patients that are already implanted. That gives us the confidence that if we have to draw statistically powered conclusions, I have to use this terminology that we have more than enough patients.
Olivier Taelman: Yes. When it comes to the ACCESS study, in fact, we reached a significant number of patients that are already implanted. That gives us the confidence that if we have to draw statistically conclusions that are statistically powered enough, I like to use this terminology, that we have more than enough patients. Maybe to give you some background, Suraj, on this, I am looking also at what is happening in the Osprey study. We know that the number of patients that we are having, we have already more than doubled the number of patients that they have in Osprey where they are also looking at CCC patients. That is just as a side comment, but I think it is important information for you to know as well. The next thing on this, why we made this decision, is we want to help patients with CCC in the U.S.
Speaker #3: Maybe to give you some background, Suraj, on this, and I'm looking also at what is going on, what is happening in the Osprey study. We know that the number of patients that we are having, we have already more than doubled the number of patients that have an Osprey, where they're also looking at CCC patients.
Speaker #3: So, just as a side comment, I think it's important information for you to know as well. The next thing on this, why we make this decision, is that we want to help patients with CCC in the U.S.
Speaker #3: As well, like we are doing in Europe in a very successful way, as demonstrated in Australia in the Better Sleep Study, and therefore here, we cannot wait.
Olivier Taelman: as well, like we are doing in Europe in a very successful way, like we demonstrated in Australia in the better sleep study. Therefore, here, we cannot wait. When you have enough patients implanted, we do think it is a well-calculated decision to stop earlier and that we can activate the 12-month follow-up timeframe. By the same time, same period next year, we will be able to publish those data. Then we submit a PMA supplement, and we should already be able to, end of 2026, beginning 2027, also to add this to our label in the U.S. and be able to help CCC patients that are currently contraindicated for AGNS.
Speaker #3: And when you have enough patients implanted, we do think it is a well-calculated decision to stop earlier. We can activate the 12-month follow-up timeframe, so by the same time, same period next year, we will be able to publish those data.
Speaker #3: Then we submit a PMA supplement, and we should already be able to, by the end of '26, beginning '27, also to add this to our label in the U.S.
Speaker #3: and be able to help CCC patients that are currently contraindicated for AGNS. Got it.
Speaker #5: Olivier, I'll question rules for the second one from me. Olivier, how are you thinking about patient outreach and packages in the product-specific attributes, supine CCC, lack of battery, whatnot?
Olivier Taelman: Olivier, I'll question you for the second one from me. Olivier, how are you thinking about patient outreach and packaging products specific to use to find CCC, lack of battery, whatnot? How are you thinking about packaging this? Do you think backing an existing Inspire Medical PMA makes sense, or are you intending on launching a targeted approach for bilateral stimulus?
Speaker #5: How are you thinking about packaging this? Do you think making that even existing? Inspired CC ads make sense, or do you intend to launch a targeted approach for bilateral sleep?
Speaker #3: So first of all, Suraj, we will further leverage our clinical data. I think this is really important, so that we look at patients' phenotypes, where we know we are extremely efficient.
Olivier Taelman: First of all, Suraj, we will further leverage our clinical data. I think this is really important so that we look at patient phenotypes where we know we are extremely efficient. You know, the adult patient population. When it comes to AHI, I would like to point this out in DREAM, our AHI range is 15 to 65, which is already different compared to competition where it is 20 to 50. So there we are already able to start to demonstrate a strong number, 15 to 65. That is one aspect. Another aspect is what we learned in market research is that for physicians, it is extremely important to know that their patients will be protected throughout the entire night.
Speaker #3: You know, the adult patient population, when it comes to AHI, and I would like to point this out in dream or AHI range, it's 15 to 65.
Speaker #3: Which is already different compared to the competition, where it's 20 to 50. So, there we're already able to start to demonstrate a strong number: 15 to 65.
Speaker #3: So, that is one aspect. Another aspect is what we learned in market research: it’s extremely important for physicians to know that their patients will be protected throughout the entire night.
Speaker #3: So, this is something that not only resonates well with ENT surgeons, but it also resonates very well with sleep physicians who have to refer patients.
Olivier Taelman: This is something that is not only resonating well with ENT surgeons, but it is very well resonating with sleep physicians who have to refer patients because they see this effect when they start studying polysomnography sleep exams. They see exactly when a patient is in what position. So it is a great benefit being able to show protection throughout the night for a sleep physician, providing them confidence when they refer a specific patient all the way to an ENT surgeon for the Genio system. Last, when it comes to the outreach, yes, we have a focused launch. We start with 25 territory managers. They all cover four to six centers. I think I already explained how concentrated the business still is in the U.S. We will scale quarter after quarter by adding roughly 50 new territory managers and each time adding up to 75 new implant sites.
Speaker #3: Because they see this effect when they start studying polysomnography sleep exams, they see exactly when a patient is in what position. So, it's a great benefit being able to show protection throughout the night for a sleep physician, providing them confidence when they refer a specific patient all the way to an ENT surgeon for a genio.
Speaker #3: And then last, when it comes to the outreach, yes, we have a focused launch. We start with 25 Territory Managers. They all cover four to six centers.
Speaker #3: I think I already explained how concentrated the business still is in the U.S. We will scale quarter after quarter by adding roughly 15 new territory managers and each time adding up to 75 new implant sites.
Speaker #3: And that's what John's point will also become one of our key metrics in measuring our success going forward. It gives us the ability, in the short term, to reach all 350 to 400 high-volume sites.
Olivier Taelman: That, to John Landry's point, will also become one of our key metrics in measuring our success going forward. It gives us the ability in short term also to reach all 350 to 400 high-volume sites. Hope this is answering your question.
Speaker #3: Hope this is answering your question.
Speaker #5: Excellent.
Speaker #1: Thank you. Please stand by for our next question. Our next question comes from the line of Ross Osborne with Canaccord Genuity. Your line is open.
Pearson Dennis: Thank you. Please stand by for our next question. Our next question comes from the line of Ross Osborne with Scanner Fitzgerald. Your line is open.
Speaker #5: Hey, guys. This is Matt Parton for Ross today. Thanks for taking the questions, and congrats again on FDA approval. So, starting off with Olivier on VAC approvals, how should we think about a reasonable pace for account openings through the remainder of 2025 and into 2026?
John Landry: Hey, guys. This is Matt Park on for Ross today. Thanks for taking the questions and congrats again on FDA approval. Starting off with Olivier on back approvals, how should we think about a reasonable pace for account openings through the remainder of 2025 and into 2026? Are there any headwinds here that we should be mindful of?
Speaker #5: And then, are there any headwinds here that we should be mindful of?
Speaker #3: Yeah, no, it's an excellent question. In the sense that what the team did really successfully is start segmenting also the VAC committees by the time they need in order to reach a decision.
Olivier Taelman: It is an excellent question in the sense that what the team did really successfully is start segmenting the VAC committees by time they need in order to reach a decision. What we learned is you have some that go extremely fast. As I already mentioned, we have the first, and we have several of those fast VAC committees where we already passed the VAC committee. You also have a number of VAC committees that will really take their time, and time can go up to nine months in some cases. Here, we will focus and follow the segmentation. The fastest, of course, there we are present immediately, and that is how we further scale up.
Speaker #3: And what we learned is you have some that go extremely fast. As I already mentioned, we have the first, we have several of those fast VAC committees where we already passed the VAC committee.
Speaker #3: But you also have a number of VAC committees that will really take their time. And time can go up to nine months in some advantage and so in some cases.
Speaker #3: So, here we will focus and follow the segmentation. The fastest, of course, there we are present immediately. And that's how we further scale up.
Speaker #3: And I do not want to set expectations on saying this is the precise number that we will achieve by the end of this year.
Olivier Taelman: I do not want to set expectations on saying this is the precise number that we will achieve by the end of this year, but it is clear that in our targeted approach, all the hospitals that we are targeting, they also will go through the VACs, and we expect all of them to gain us an approval in the coming six months.
Speaker #3: But it is clear that in our targeted approach, all the hospitals that we are targeting, we will also go through the VACs, and we expect all of them to gain us an approval in the coming six months.
Speaker #5: Got it. That's super helpful. And then that one for John here. You know, as we're thinking about spend in the back half of the year and into 2026, as you guys filled out your commercial infrastructure in the U.S., can you kind of walk us through some of the puts and takes around operating levers that we should be mindful of?
John Landry: Got it. That is super helpful. That one for John Landry here. As we are thinking about spending the back half of the year and into 2026, as you guys build out your commercial infrastructure in the U.S., can you kind of walk us through some of the puts and takes around operating leverage that we should be mindful of?
Speaker #3: Sure, absolutely. From an OpEx perspective,
Kyle: Sure, absolutely. From an OpEx perspective, we don't provide specific guidance, but maybe we can provide some color in terms of how we're thinking about the investment levels. For the back half of this year, in terms of OpEx spend, we would expect to see R&D continue at a pretty consistent rate and then maybe be a little bit up year over year, considering some of the investments that we're making in the IP litigation front. From an SG&A perspective, that will be up, obviously, year over year, considering the investments that we've made in our sales and commercial efforts in the U.S. with the 50 highly talented professionals we have in that organization.
Speaker #4: You know, we don't provide specific guidance, but maybe I can provide some color in terms of how we're thinking about the investment levels. So for, you know, the back half of this year, in terms of OpEx spend, you know, we'd expect to see R&D continue at a pretty consistent rate.
Speaker #4: And then maybe be a little bit up year over year, considering some of the investments we're making in the IP litigation front. From an SG&A perspective, that'll be up, obviously, year over year, considering the investments that we made in our sales and commercial efforts in the U.S.
Speaker #4: With the 50 highly talented professionals we have in that organization, as we look at 2026, from an overall investment level perspective, we'd expect the majority of the increase next year to be in the way of SG&A, as we increase the size of the commercial organization again by expanding it by those scalable units of 15 territory managers over the course of the year.
Kyle: As we look at 2026, from an overall investment level perspective, we would expect the majority of the increase next year to be in the way of SG&A as we increase the size of the commercial organization again by expanding it by those scalable units of 15 territory managers over the course of the year. We could expect to see potentially the SG&A spend nearly double in 2026 over the levels seen in 2025.
Speaker #4: So you know, we could expect to see potentially the SG&A spend, you know, nearly double in 2026 over the level seen in 2025.
Speaker #5: Got it. Thanks for the color. Congrats again, guys.
John Landry: Got it. Thanks for the color. Congrats again, guys.
Speaker #3: Thank you.
Olivier Taelman: Thank you.
Speaker #1: Please stand by for our next question. Our next question comes from the line of David Rescott with Bayer. Your line is open.
Pearson Dennis: Please stand by for our next question. Our next question comes from the line of David Rescott with Baird. Your line is open.
Speaker #4: Great. Thanks for taking the questions, and congrats on the approval here. Wanted to ask first about reimbursement, the VAC, and the prior authorization processes that you've called out.
Kyle: Great. Thanks for taking the questions and congrats on the approval here. I wanted to ask first on reimbursement, the VAC, the prior auth processes that you have called out in the prepared remarks. I guess, can you just help us understand what considerations go into those VAC and prior auth conversations? Are you definitively locked into reimbursement there? Is that fully ironed out? Just how do we think about what the prior auth and VAC processes are relative to what the underlying CPT code 64568 and commercial coverage has?
Speaker #4: In the prepared remarks, I guess can you just help us understand, you know, what considerations go into those, you know, VAC and prior auth conversations?
Speaker #4: Are you definitively kind of locked into reimbursement there? Is that fully ironed out? Just how do we think about what the prior authorization and VAC processes are relative to kind of what the line CPT code and commercial coverage have?
Speaker #4: Sure. Yeah, thanks. The question, David, yeah. So early on, it's, you know, clearly early on in the process, but in terms of the approvals that we receive, vis-à-vis the VAC and/or the pre-authorizations, the answer is yes.
John Landry: Sure. Yeah. Thanks for the question, David. So early on, it's clearly early on in the process, but in terms of the approvals that we receive vis-à-vis the VAC and/or the pre-authorization, the answer is yes. We've gone through the process. I think really what we're looking to do there is demonstrate the clinical efficacy and the effectiveness of the technology, certainly utilizing the AGNS code, the CPT code 64568. We've been able to have success in demonstrating that, at least in this early stage, to those hospitals and accounts and centers where we've completed the VAC. As Olivier Taelman mentioned, there are various lengths of process for these VACs as well as the pre-authorization process. The VAC approvals can range anywhere from very short periods of time, up to nine months. In the pre-authorization process, it's extended as well.
Speaker #4: So we've gone through the process. I think really what we're looking to do there is demonstrate the clinical efficacy and the effectiveness of the technology.
Speaker #4: Certainly. Utilizing the HTNS code, the 64568 code on the CPT side, we have been able to demonstrate that, at least in this early stage, to those hospitals and accounts and centers where we've completed the VAC. As Olivier mentioned, there are various lengths of process for these VACs, as well as the pre-authorization process. The VAC approvals can range anywhere from very short periods of time up to nine months.
Speaker #4: And, you know, the pre-authorization process has been extended as well. So that's where we're at at this point in time. I look forward to continuing to build this body of approvals.
John Landry: That's where we're at at this point in time and look forward to continuing to build this body of approvals.
Speaker #3: Yeah. And maybe in addition to this, if you allow me to add, AGNS is no longer one company that is offering an AGNS solution.
Olivier Taelman: Yeah. In addition to this, if you allow me to add, AGNS, there is no longer one company that is offering an AGNS solution. With Genio, we enter the market. There is no option to choose. As of today, there is an AGNS treatment solution, and there are different companies offering this. I think that is also important. The previous work done in the past was also linked to AGNS. All the VAC committees recognize this, and they know what it is and what it can do. As of today, there are two companies who can offer a solution, and it is up to their physicians that will decide together with the patient what solution they will choose.
Speaker #3: I mean, with Genio, we entered the market. There is now an option to choose. And that's why today, as of today, there is an AGNS treatment solution, and there are different companies offering this.
Speaker #3: And I think that's also important. The previous wording done in the past was also linked to AGNS. All the VAC committees recognize this, and they know what it is and what it can do.
Speaker #3: And as of today, there are two companies that can offer a solution, and it's up to their physicians to decide together with the patient what solution they will choose.
Speaker #4: Okay, great. And then maybe on the, you know, CCC patient population, you know, you've got the no contraindication. You know, there's the warning that it wasn't tested.
Kyle: Okay. Great. And then maybe on the CCC patient population, you know, you've got the no contraindication. You know, there's the warning that it wasn't tested, but you have ACCESS that is coming. One, I guess I do not know if you called out a timeline. I might have missed it on the ACCESS side for when that data should read out. But I guess how do we think about the patients that are on the CCC side that can get treated today versus those that you can kind of go after and target once you have ACCESS kind of fully in hand?
Speaker #4: But you have access that is coming, one, I guess, I don’t know if you called out a timeline. I might have missed it on the access side for when that data should read out.
Speaker #4: But I guess, how do we think about the patients that are on the CCC side that can get treated, you know, today, versus those that you can kind of go after and target once you have access kind of fully in hand?
Speaker #3: So, when it comes to the ACCESS trial, we have now stopped the enrollment. So, the time clock for 12 months can start. Twelve months from now, we will have the data of our ACCESS patients.
Olivier Taelman: When it comes to the ACCESS trial, we stopped the enrollment. The time clock for 12 months can start. Twelve months from now, we will have the data of all ACCESS patients. Based on this study data, we will submit a PMA supplement. Normally, this takes roughly another six months before we grant a supplement. If you do the math, the earliest end of Q4 2026, beginning Q1 2027, we could have CCC patients added to the label. Today, with having no contraindications, we are very proud that the FDA is recognizing already that CCC is something where they would like to see U.S.-specific data before adding the label, but where they also recognize the fact that CCC should not be a contraindication. I think that is an important first step in the direction of opening it up in the U.S. market for OSA patients suffering from CCC.
Speaker #3: And then, based on this study data, we will submit a PMA supplement. Normally, this takes roughly another six months before the FDA grants you a supplement.
Speaker #3: So if you do the math, the earliest end of Q4 '26, beginning Q1 '27, we could have CCC patients added to the label. Today, with having no contraindication, we are very proud that the FDA is recognizing already that CCC is something where they would like to see U.S.-specific data before adding the label.
Speaker #3: But they also recognize the fact that CCC should not be a contraindication. I think that's an important first step in the direction of opening it up in the U.S.
Speaker #3: market for patients with OSA suffering from CCC.
Speaker #4: Okay, so would it be fair to assume that you can start treating CCC patients based since there is no contraindication? Maybe bump the gas on that once you have access out and the PMA supplement in?
Kyle: Okay. So, would it be fair to assume that you can start treating CCC patients today since there is no contraindication? Maybe pump the gas on that once you have ACCESS out and the PMA supplement in, or in the near term, are you really just waiting for the ACCESS results? Thank you.
Speaker #4: Or in the near term, are you really just waiting for the access results? Thank you.
Speaker #3: So, in the near term, we are waiting for the ACCESS results. And let me be very clear on this one: we would never promote an off-label indication.
Olivier Taelman: We are waiting for the ACCESS results. Let me be very clear on this one. We would never promote an off-label indication. Today's CCC, it is also for Genio off-label in the U.S. So we would never, ever promote this. On the other hand, it is clear that it is not a contraindication, and it is in the warning section of our labeling. Physicians, they know what this means.
Speaker #3: And today's CCC, it's also for Genio off-label in the U.S. So we would never, ever promote this. But on the other hand, it is clear that it's not a contraindication, and it is in the warning section of our labeling.
Speaker #3: So, physicians may know what this means.
Speaker #4: Okay, perfect. Thank you.
Kyle: Okay. Perfect. Thank you.
Speaker #1: Thank you. Please stand by for our next question. Our next question comes from the line of Michael Pollock with Wolf Research. The line is open.
Pearson Dennis: Thank you. Please stand by for our next question. Our next question comes from the line of Michael Pollock with Wolf Research. The line is open.
Speaker #4: Hey, good afternoon. I have two questions. First, can you confirm as you launch now in the U.S. your intent to price at an Inspire level of $25,000, or has the thought process on pricing changed?
Kyle: Hey, good afternoon. I have two. First one, pricing. Can you confirm, as you launch now in the U.S., intent to price at Inspire Medical's level, $25,000, or has the thought process on pricing changed?
Speaker #3: Definitely, indeed. So we use the same CPT code, and we are following also the price strategy that comes with the CPT code, to your point.
Olivier Taelman: Yep. No, indeed. So, we use the same CPT code, and we are following also the price strategy that comes with the CPT code to your point.
Speaker #4: Okay, that's what I figured. Just thought it worth clarifying as we go into launch. And then my second question is, as you look to open accounts, is there an ask you're making of these surgeons?
Kyle: Okay. That is what I figured. Just thought it worth clarifying as we go into launch. My second question is, as you look to open accounts, is there an ask you are making of these surgeons? You invest in them. You train them. They are going to be targeting and competing for patients on their behalf. That is an investment that you make. What kind of return do you ask of these initial centers, if anything? I am just thinking, like, look, they are all in the business of hypoglossal nerve stems. They have large wallets. What is a share of wallet that you are wanting? Kind of a maybe not a firm commitment, but a soft commitment from these surgeons as you get going in this initial cohort? Is it 10%, 20%?
Speaker #4: You know, you invest in them, you train them, you're going to be, you know, targeting and competing for patients on their behalf. That's an investment that you make.
Speaker #4: What kind of return do you ask of these initial centers, if anything? And I'm just thinking, like, look, they're all in the business of hypoglossal nerve stems.
Speaker #4: They have large wallets. What is a share of wallet that you're wanting—kind of maybe not at the firm commitment, but a soft commitment from these surgeons as you get going in this initial cohort?
Speaker #4: Is it 10%, 20%? Is it more? I'd love a feel for how you go about those initial conversations and signing up this initial group of implantors.
Kyle: Is it more? I would love a feel for how you go about those initial conversations and signing up this initial group of implants. Thank you.
Speaker #4: Thank you.
Speaker #3: Yeah, no, thank you, Mike, for this question. And it's also a question, of course, as you can imagine, that we internally discussed as well because we have a lot of demands on physicians who are reaching out to be trained on the Genio technology.
Olivier Taelman: No, thank you, Mike, for this question. It is also a question, of course, as you can imagine, that we internally discussed as well because we have a lot of demand from physicians who are reaching out to be trained on the Genio system technology, and we can, unfortunately, not train all of them at the same time. So what we are asking is, before a physician is eligible to join a training or invited for a training, they need to come with five patients, clearly defined patients, and we use the same criteria as in the DREAM pivotal study. So we ask them to come with five patient cases. Then they get a training. We can already discuss those five patients so they can be implanted right after they go back after being trained. That is what we do.
Speaker #3: And we can unfortunately not train all of them at the same time. So what we are asking is, before a physician is eligible to join a training or is invited for a training, they need to come with five clearly defined patients, and we use the same criteria as in the DREAM study.
Speaker #3: So we ask them to come with five patient cases. Then they get the training. We can already discuss those five patients so they can be implanted right after they go back after being trained.
Speaker #3: That's what we do. So when it comes to market share, because you are alluding to your 10% or 20% market share, honestly, we don't, at this stage, think that if they are well trained with high-quality training and they do their five cases—meaning that they will all go through their surgical learning curve—then we are convinced that they will make the right decision when patients are coming, and that also patients will know if they can choose bilateral stimulation with a single incision.
Olivier Taelman: Now, when it comes to market share, because you were alluding also to the last 10% or 20% market share, honestly, we do not at this stage. We do think that if they are well-trained, high-quality training, they do their five cases, meaning that they will all go through their surgical learning curves, then we are convinced that they will make the right decision when the patients are coming. Then also patients will know if they can choose a bilateral stimulation with a single incision. You know, all the different differentiated factors, full body MRI compatibility that we will be able to capture a lot of patients with our Genio system technology.
Speaker #3: You know, all the different differentiating factors: full body MRI compatibility that we will be able to capture a lot of patients with our Genio technology.
Speaker #4: Thank you for the color.
Kyle: Thank you for the color.
Speaker #1: Thank you. Ladies and gentlemen, that concludes our question-and-answer session. I will now turn the call back over to Olivier Taelman and Kyle for closing remarks.
Pearson Dennis: Thank you. Ladies and gentlemen, that concludes our question and answer session. I will now turn the call back over to Olivier Taelman for closing remarks.
Speaker #3: Thank you again for your time today and your continued support of Nyxoah. As I mentioned in the beginning, this is the most exciting time in our company's history.
Olivier Taelman: Thank you again for your time today and your continued support of Nyxoah. As I mentioned in the beginning, this is the most exciting time in our company history. We are so excited to be able to launch in the U.S. I would also not forget our international markets where we are also making good progress, but it is clear that the market is in the U.S. Finally, after so many months, years of hard work, I am pleased that we can enter this. The entire team is extremely excited. I will look forward also to updating you on our progress in the coming months. Thank you all again, and have a nice day.
Speaker #3: We are so excited to be able to launch in the U.S. I would also not forget our international markets, where we're also making good progress. But it's clear that the market is in the U.S.
Speaker #3: And finally, after so many months and years of hard work, I'm pleased that we can enter this, and the entire team is extremely excited.
Speaker #3: So you will, and I will look forward also to updating you on our progress in the coming months. Thank you all again, and have a nice day.
Pearson Dennis: Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.