NASDAQ:NYXH Nyxoah Q1 2024 Earnings Report $6.03 -0.02 (-0.33%) Closing price 04/23/2025 04:00 PM EasternExtended Trading$6.14 +0.11 (+1.81%) As of 04/23/2025 06:04 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Nyxoah EPS ResultsActual EPS-$0.45Consensus EPS -$0.45Beat/MissMet ExpectationsOne Year Ago EPSN/ANyxoah Revenue ResultsActual Revenue$1.33 millionExpected Revenue$1.20 millionBeat/MissBeat by +$130.00 thousandYoY Revenue GrowthN/ANyxoah Announcement DetailsQuarterQ1 2024Date5/14/2024TimeN/AConference Call DateTuesday, May 14, 2024Conference Call Time4:30PM ETUpcoming EarningsNyxoah's Q1 2025 earnings is scheduled for Tuesday, May 13, 2025, with a conference call scheduled on Wednesday, May 14, 2025 at 6:00 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Earnings HistoryCompany ProfilePowered by Nyxoah Q1 2024 Earnings Call TranscriptProvided by QuartrMay 14, 2024 ShareLink copied to clipboard.There are 9 speakers on the call. Operator00:00:00Ladies and gentlemen, thank you for standing by. Welcome to the Nixo First Quarter 20 24 Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference call is being recorded. Operator00:00:34I would like now to turn the conference over to Mikaela Kirkwood, Investor Relations and Communications Manager. Please go ahead. Speaker 100:00:45Good afternoon and good evening, everyone, and welcome to our earnings call for the Q1 of 2024. I am Mikaela Kirkwood, Investor Relations and Communications Manager at NextElla. Participating from the company today will be Olivier Tillman, Chief Executive Officer and Lalique Moreau, Chief Financial Officer. During the call, we will discuss our operating activities and review our Q1 financial results released after U. S. Speaker 100:01:10Markets closed 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 of the Investor Relations tab of our website. Before we begin, I would like to remind you that any statements that relate to expectations or predictions of future events, market trends, results or performance are forward looking statements. All forward looking statements are based upon our current estimates and various assumptions. Speaker 100:01:43These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward looking statements. All forward looking statements are based upon current available information and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these statements. For a listen description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 20 F filed with the Securities and Exchange Commission on March 20, 2024. With that, I will now turn the call over to Olivier. Speaker 200:02:23Thank you, Mikaela. Good afternoon and good evening, everyone, and thank you for joining us for our Q1 2024 earnings call. 2024 has been transformational for NKTROVA. In March, we announced our DREAM U. S. Speaker 200:02:39Pivotal study achieved its primary endpoints and demonstrated that Jynneo has the potential for best in class outcomes for OSA patients. I would like to congratulate our clinical team on these terrific results. Our regulatory team is working diligently to file the 4th and final module in our modular PMA submission this quarter, which will set the stage for entering the U. S. Market upon FDA approval as early as the end of 2024. Speaker 200:03:11Additionally, Doctor. Moritz Boone, one of the pioneers in hypoglossal neurostimulation, joined us from Thomas Jefferson University as Chief Medical Officer, and we announced a partnership with the American Association of Otolaryngology at the Neck Surgery Foundation to drive Medicare and commercial payer coverage. Commercially, we reported 1st quarter sales of €1,200,000 almost tripling revenue from the Q1 of 2023 and benefiting from our focused approach on strengthening collaboration between implant surgeons and referring sleep physicians. To recap DREAM, the study had co primary endpoints of AHI responder rate per the share criteria at 12 months and ODI responder rate at 12 months. At baseline, subjects had a mean AHI of 28.0, ODI of 27.0 and a body mass index of 28.5. Speaker 200:04:17On an intent to treat or ITT basis, DREAM study showed an AHI responder rate of 63.5 percent with a p value of 0.002 and an ODI responder rate of 71.3% with a p value less than 0.001. With these strong results, the DREAM study met its primary endpoints. Additionally, subjects demonstrated a median 12 month AHI reduction of 70.8% with similar AHI improvements in supine and nonsuppine sleeping positions. The safety results were favorable with 11 serious adverse events of SAEs in 10 subjects resulting in an SAE rate of 8.7%. Out of the 11 SAEs, 3 were device related and there were 3 explants. Speaker 200:05:24The DREAM results further differentiate Genio as it was the first AGNS study to require patients to sleep at least 60 minutes in the supine position and demonstrated strong efficacy with patients sleeping supine and non supine. This is of particular importance since published data show increased OSA severity in the supine position, with AHI doubling in the supine versus the lateral position. On average, people sleep 35% to 40% in a supine position during a standard night, which was in line with our PSG findings in DREAM. This means that irrespective of a patient's sleeping position, Jynio maintains its efficacy. Based on early feedback from the physicians, this can be very impactful on therapy selection. Speaker 200:06:20It supports our mission to make sleep simple again, and we intend to apply for the inclusion of supine efficacy results in our label. With the positive DREAM results, we are now finalizing our modular PMA submission. We have responded to the FDA questions on the first three modules and are in an interactive review and anticipate filing the 4th and final module this quarter. We are preparing for a launch by the end of 2024 as based upon modular PMA review cycle times. We anticipate FDA approval of late 24 or early 25 as we do not control FDA time lines. Speaker 200:07:02In parallel, we continue making progress on the reimbursement side as we are establishing reimbursement pathways with commercial payers, Medicare and Medicaid. The reimbursement team is working closely with the AAO and reimbursement experts to secure coverage at FDA approval. Ahead of approval, we will be conducting a payer feedback interview with the former CMS and Commercial Plan Medical Director as well as participate in the early payer feedback program for the FDA designed to provide direct feedback for major payers such as UnitedHealthcare, Blue Cross Blue Shield, Aetna as well as CMS. Upon commercialization, we will have a prior authorization team in place to assist with claims submission and payment. Our U. Speaker 200:07:59S. Focus is significantly increasing, highlighted by the recent addition of Doctor. Mo Boon as Chief Medical Officer. Doctor. Boon, who joins Nyxoah from Thomas Jefferson University, is internationally recognized as one of the most experienced surgeons in the field of OSA and AGLS. Speaker 200:08:21Being able to have such high caliber talent joining Nyxoah is a strong validation of the opportunity for Genio to disrupt the OSA market. We are actively building our U. S. Commercialization team to be ready to launch by the end of this year. The current AGNS market in the U. Speaker 200:08:42S. Is very concentrated, allowing for a laser focused launch, breaking the current monopoly with ERT sites, while establishing a patient referral pathway from sleep specialists. As part of FDA approval process, we have a usability study with 31 physicians that are the top AGNS implanters in the U. S, and their feedback was overwhelmingly positive. Providing a little more color on the usability study. Speaker 200:09:18Naive surgeons, meaning surgeons without experience with Jynneo, were invited to participate in a training session to unaudibly and safely use the device. The training contained theoretical session followed by both animal and cadaver implants. 12 hours later, mimicking a real ORF setting, surgeons had to repeat the implant without guidance to demonstrate they've properly retained the knowledge on device programming and acquire the implantation technique, always ensuring patient safety and comfort during the procedure. These surgeons were adamant. They want to be the 1st Genio implanters in their areas and convinced of the differentiation of GenioVest's current AGNS technology in terms of invasiveness, patient centricity, safety and the simplicity to treat OSA patients regardless of their sleeping position. Speaker 200:10:22In addition, a recent independent survey demonstrated that over 20% of U. S. AGNS candidates are declining a pacemaker based platform technology due to their concerns over the invasiveness and having implantable battery in the chest. Going back to Europe, 1st quarter sales was €1,200,000 an increase of 177% of the Q1 of 2023. As part of our commercialization of commercial proof of concept in Germany, we see that, 1st, the majority of accounts became mixed implanting accounts embracing Genio in their practice. Speaker 200:11:092nd, parity penetration is strongly accelerating as a result of Jynneo entering the market as a new player. And 3rd, there is a large pool of CPAP quitting patients in need for treatment, which can be addressed through establishing a strong collaboration between implanting surgeons and referral sleep physicians, highlighted by our ResMed collaboration. In summary, we started 2024 strongly by reporting positive DREAM data, further disconcerting Jynneo with our unique supine dip. For the remainder of the year, we are working towards FDA approval by the end of the year and commercial readiness for a strong U. S. Speaker 200:11:56Launch in 2025. With that, I'm pleased to turn the call over to our CFO, Louis Morreau, who will provide a financial update. Speaker 300:12:08Thank you, Olivier. Good day to everyone and thank you for joining us today. Revenue for the Q1 ended March 31, 2024 was €1,200,000 a 177% increase over the Q1 of 2023. Total operating loss for the Q1 was €12,200,000 versus €11,400,000 in the Q1 of 2023, driven by an acceleration in commercial investments in the U. S. Speaker 300:12:42As well as in Europe. As of March 31, 2024, cash and financial assets totaled €44,300,000 compared to €57,700,000 on December 31, 2023. During the Q1, our monthly cash burn was €4,500,000 Based on our current cash position, we have a runway into late 2024, which includes the building of the U. S. Commercial team. Speaker 300:13:17This concludes the formal part of our presentation. Operator, I will turn the call over to you to begin our Q and A session. Operator00:13:27Thank you. The first question comes from Jon Block with Stifel. Your line is now open. Speaker 400:13:57Thanks. Good afternoon. First question, Olivier, just any details on where market share shook out in 2023 for Genio in Germany? And your thoughts on 2024? And then part 2 of that first question would just be the burn rate that we can expect as you ramp up the commercialization efforts in the coming months? Speaker 400:14:21I think headcount and prepping for launch, as you mentioned, by potentially Speaker 500:14:27the end of this year, Speaker 400:14:27Q4 of 2024? And then I'll ask my follow-up. Thanks, guys. Speaker 200:14:33Thank you. So, John, first of all, thank you for the questions. Looking back at 2023 and the annual market share, we ended up with 27% overall market share and we had a very strong Q4 close in 2023, bringing the market share close to 50%. So that was, I think, the first part of your question. The second part was Speaker 400:14:59Just how we should view the I'm sorry, how we should view whether you want to do monthly burn or quarterly burn as you ramp up some of the commercialization efforts to prepare by launch Speaker 500:15:08by the end of this year? Speaker 300:15:12So we burned EUR 4,500,000 in Q1. We expect the burn rate to remain steady for the first half of the year and then begin to ramp up in the second half as we accelerate investments in the U. S. Commercial organization. We as we said, we have cash until late 2024 and that includes the build of the U. Speaker 300:15:34S. Commercial team. Speaker 400:15:38Okay. Got that. And if I have any additional questions there, I'll clarify offline. I think just to pivot for the second question, post the release of the DREAM top line data, we performed checks among 30 physicians and asked them how they view the DREAM data relative to superior Speaker 600:15:58and Speaker 400:16:01about 17% saying, superior and about 17% saying inferior. So painting it with a broad brush, largely equivalent. Here we are just almost 2 months removed from the top line data being released Olivier. And I'm curious if maybe you can talk about what you've heard or others at Nexo have heard from the docs and maybe the reaction in the marketplace to the data, that'd be very helpful. Speaker 200:16:28Yes. No, no, definitely, John. And I also thank you for the work that you did on gathering this data. So let me, 1st of all, remind you that the study was not designed for a head to head comparison. There are a few different characteristics making DREAM more challenging than stores. Speaker 200:16:46To name the most important one is having minimum 60 minutes supine sleep for all our patients in order to qualify as a responder. And there is also the broader AHI range, where in DREAM you have a range between 15% to 65%, where in store the range was 20 to 50. Now that being said, of course, I fully understand the nature of the question. I also fully understand why physicians and other people are looking how to compare these data. So our AHI and ODI respond rates are in line with our competitors' study starts, calculated on a 10 to 3 basis and our median AHI reduction is even slightly higher. Speaker 200:17:30In general, as physicians are well aware of, it's harder to control OSA when patients are supine compared to non supine because it's more difficult to maintain an open airway in a supine position, mainly driven by gravity. While we plan to hold the data for publication, I can already comment that Ingenio showed similar AHI reductions in both supine and non supine positions, while requiring patients to sleep supine may dream more challenging. The data provides evidence that Jynneo will be able to control patients' OSA regardless of their sleeping position. And I do think and this is also the feedback that we are getting when we are talking more in-depth with physicians and also know that we have Doctor. Bolan Bocht explaining it even better than I can to other physicians. Speaker 200:18:18We see that this is really perceived as a really, really differentiating factor, making the choice for the physician simpler because they do not need to worry whether the patient is sleeping supine or non supine knowing that in data 35% to 40% of a normal standard night, people are sleeping on their backs. So I do think that the supine data aspect is really differentiating Genio from STORE and it's also differentiating and showing a stronger efficacy in the specific supine position, which we like to say and claim that this is showing a superiority compared to what was demonstrated in the STORES trial. Speaker 400:19:01Very helpful. Thanks guys. Operator00:19:04One moment for the next question. The next question comes from Suraj Kalia with Oppenheimer. Your line is open. Speaker 600:19:16Good afternoon, Olivier, Louis. Can you hear me all right? Speaker 200:19:19Yes, we can. Hello. Speaker 600:19:22So Olivier, congrats on all the progress. Olivier, just piggybacking on your comments about supine, right? Obviously, that peaked everyone's curiosity. And my first question is a multipart question, if I could. How is the debate on hypoglycinnervestem efficacy supine, non supine? Speaker 600:19:45How is it growing in the field? And also recently, there was an Inspire paper that was talking about decreased efficacy in supine position. Olivier, forgive me. Olivier, if you look at one of the arguments made is, well, the titration is done in supine position. So this whole debate becomes moot. Speaker 600:20:13I'd love to have your take on this. When is the titration really done? Is it supine, non supine? If you could shed some color there and also the implications for a label, if really the titration is done in a supine position? Sorry, it was a multipart question. Speaker 600:20:33Hopefully, you got the gist of it. Speaker 200:20:35I hope I will be very complete in my answer, Suraj. But let me start a little bit the first part. So yes, this supine versus non supine is also creating a lot of further discussion within the ENT sleep surgeons community for the simple reason that when surgeons are deciding to choose for lithography, it's really important that they try to keep it as simple as possible. And knowing that you have the same OSA of the same airway opening in both supine and non supine position is definitely an advantage. So that being said, if we look at published data showing that 35% to 40% of the time people are sleeping in a supine position, you understand why this is becoming extremely important. Speaker 200:21:23On top, we also know that when a patient moves and turns into a supine position that AHI is twice as high when they are occupying versus when they are non supine. There were even patients who are not suffering from moderate oxyveer OSA when they are non supine and become a severe OSA patient once they turn supine. So again, an illustration how important it is to have a technology that can guarantee that the airway is opening or stays open during supine sleep position. Now at this moment, DREAM is the only study to require patients to sleep minimum 60 minutes supine at a 12 month follow-up visit, and this result showed similar AHI reductions compared to STOR. However, for Jynneo, it did not matter whether patients were sleeping supine or nonsuppine. Speaker 200:22:19STORE did not have a requirement to sleep supine at the 12 month visit and has not presented any data on supine efficacy from the study in the SORC trial. And that brings me to your next question. Recently, there was a publication done by INSPIRE on supine data. We have disclosed in dream that our median AHI reduction in supine and non supine sleeping positions were similar, implying around 70% in supine. If you compare the 70% that we showed to the 51% supine 1,000,000 AHI reduction reported in the recent publication. Speaker 200:23:00Based on this, I hope you agree with me that I can conclude that Jynneo has a superior outcome in a supine position. Have I completed my explanation? Or am I missing still something? Speaker 600:23:16No, sorry. It was a multi part. I mean, the titration part, Olivier, one of the arguments as well, the titration for hypoglycinergicym is done essentially in supine position. So it should not matter the supine, non supine. In all honesty, I never thought about at what point is the titration done? Speaker 600:23:39And I'd love to get some clarity on how is titration done for Genio? Speaker 200:23:46Yes. So let me start by first commenting on the fact titration is done in a supine position. So this is not the case for Genio. But if we just stay on the topic that titration is done for supine position, it would also implies that there is an overtitration in a non supine position. And we all know how sensitive patients can be for stimulation. Speaker 200:24:12The last thing we want to do is wake them up. So I do think it's important that the patient will get the adequate stimulation. And therefore, again, with our bilateral stimulation that we can offer and the way we do this on a tailor made based studying the PSG exam and pre programming. For activationship, we can offer a solution where we stimulate precisely for the patient in function of his or her needs to maintain the airway open. To that extent, knowing that we have similar airway opening effects using the same stimulation parameters, supine and non supine, this is again a great advantage that we offer and that we can contribute completely on the fact that we have a bilateral stimulation. Speaker 600:25:01Got it. And Olivier, for my follow-up question, if I could. I presume the label discussions start in Q3, I'm guessing. And also the 31 physicians, high volume Inspire docs that you all are considering presumably as low hanging fruit and preaching the virtues of Genio. I'd love to understand how you all are sensing the choice of device is going to shape up once you all become commercial? Speaker 600:25:32Gentlemen, congrats on the progress and thank you for taking my questions. Speaker 200:25:36Well, thank you for the question, Surajan. And again, to your point, we also start opening the label discussion that is part of our module 4 submission. So that is what we will bring in. And based on our data, we will really pursue the option to have the supine position really explicit in our label. And I think based on this, and I'm coming back to our mission, and that is making sleep simple again, based on this, for a physician, it becomes obvious working with Genio, you know that you don't need to worry too much and that you can always maintain the airway of patients open regardless of their sleep position. Speaker 200:26:14And that is really, really the clear concept. Operator00:26:20One moment for the next question. Our next question comes from Adam Meter with Piper Sandler. Your line is open. Speaker 700:26:33Hi, good evening guys. Thank you for taking the questions and congrats on the progress. I wanted to start by asking about some of the preparations that you're making from a sales force and manufacturing standpoint. If I heard some of the remarks correctly, it sounds like that's the onboarding of sales U. S. Speaker 700:26:53Sales folks is more back half loaded. But I was hoping you could get a little bit more granular there. So how many U. S. Sales reps have you hired at the moment? Speaker 700:27:04Kind of how should we think about that building in the back half of the year? Where do you expect to be at launch? And then I guess kind of a similar question, just talk about manufacturing capabilities and capacity and how you feel about that going into U. S. Launch at the end of the year? Speaker 700:27:21And then I had a follow-up. Thanks. Speaker 200:27:23Yes. Well, thank you, Adam, for the question. So when we look at our launch strategy, as I mentioned earlier in the call, it's clear that currently AGNS in the U. S. Is a very concentrated business. Speaker 200:27:35So it allows us to have a laser focused launch on top AGNs, which constitute the vast majority of implants. Next to this, we want to develop relationship with key sleep centers to drive referrals. So limited and efficient sales force sized appropriately for a targeted launch, which we can scale them opportunistically over time. Being very concrete, we plan to launch with a sales team of around 25 people being laser focused on those top AGI cytokines. Now the scalability, patient follow-up strategy, which includes field clinical engineers to monitor implants and patient management specialists to focus on titration and patient follow-up. Speaker 200:28:17This increases the sales force capacity as sales reps can focus on lead generation and can also focus on what they are hired for and that is increasing sales. There will be a limited DTC focus on product differentiation, of course. And on top of this, we also will have a trial authorization team in place at launch. Now how will we differentiate and how will we break the monopoly and take share from the competition? A, we will focus on our superior efficacy due to the supine AHI reduction. Speaker 200:28:51I think I already was pretty clear about this. And B, we will have our product differentiation, no implantable post generation, implant for life, fully scalability of our technology, a single incision, no leads, no risk for lead breakage. So those 2 will be our key factors that we will use within our sales force. The superior efficacy based on supine HII reduction and product differentiation making sleep center again. Speaker 700:29:23That's good color, Olivier. And just from a manufacturing standpoint, I don't think we need to spend too much time here, but just wanted to ask I'd check if you guys are indeed feeling good about the ability to manufacture and hit the ground running in 'twenty five in the U. S? Speaker 300:29:39And then Speaker 600:29:40I had one follow-up. Thanks. Speaker 200:29:41Yes. Go ahead. So for the U. S. Sales specifically, we have contracted with a leading U. Speaker 200:29:47S. Medical device manufacturer. And so eventually also the same as competition is using that will provide systems for the U. S. Market at the first stage. Speaker 200:29:58Currently, we are having our Belgium manufacturing sites for European commercial supply that will be further extended to also be able to supply for the U. S. And we are keeping our historical manufacturing facilities in Tel Aviv for clinical trial inventory. The manufacturing lines are highly scalable, particularly as we will launch with a ceramic encapsulation version of Jynio, which is easier and less expensive to manufacture. Speaker 700:30:27Yes. Good color there Olivier. Thank you for that. And for the follow-up, I wanted to switch over to reimbursement and ask for more color about the strategic partnership with AAO, HNSF. What more can you tell us about kind of the background of that agreement or the genesis of the agreement? Speaker 700:30:47And then I'll also ask any update in terms of how we're thinking about coding vehicle for Genio in the U. S. And just pace of payer coverage in the United States? It sounds like you expect U. S. Speaker 700:31:00Payers to come on pretty quickly after approval, but maybe just talk about the confidence there. And thank you for taking Speaker 200:31:08the questions. Yes. No, no, definitely. So we have partnered with AAO, which will make a formal recommendation on an interim CPT code for use for us to use at launch, directly at launch when we have obtained FDA approval. At launch, doctors will submit Medicare claims using the AAO recommended CPT code, which will closely match the Jynneo procedures and is currently covered by all Medicare Administrative Contractors or MACs. Speaker 200:31:40The reimbursement will be in line with current AGNS payment rates, and I think that's also important. We will pursue a Genio specific CPT code over time, but based upon precedent, this will likely take a couple of years. Now in going forward, we know that all the MACs have local coverage decisions for AGNS. And in collaboration with them, we will have limited coverage optical from Genio that will leverage those decisions. We have the full influence and support of the AEO for our strategy demonstrated in their recent partnership. Operator00:32:26The next question comes from Ross Osborne with Cantor Fitzgerald. Your line is open. Speaker 800:32:33Hey, guys. Thanks for taking our questions. Maybe just one for me. I would be curious to hear if there's any update on the ACCESS trial? And then how you think education efforts will progress post data there in the U. Speaker 800:32:46S. In terms of being able to utilize your offering with CCC patients, which historically has not been done? Thank you. Speaker 200:32:54Thank you, Rolf and thank you for the question. So we continue to make progress with the ACCESS study. But as I mentioned before, we will not be disclosing the number of patients implanted. That said, we still plan to close implant by the end of this year, by the end of 2024. Once we close the study, there will be a 12 month follow-up that will bring us to the end of 2025. Speaker 200:33:17Then we will file a P and A supplement. And therefore, we anticipate a 6 to 9 month review period. So we expect to receive a label expansion in mid-twenty 6. And I know this was not really the question, but I do think it's important also to strategically carve out. When I was talking about supine versus non supine, we're also looking in the remap non CCC patients. Speaker 200:33:41There, we are really making sleep simple again by physicians not having to worry about in what position people are sleeping. Now when you look at CCC patients versus non CCC, again, this is under the same umbrella in our strategy in making sleep simple again that all this time also physicians don't need to worry whether a patient is suffering from CCC or non CCC. Not to forget, this will also eliminate the currently in place to further determine whether a patient is a CCC or a non CCC patient. So all this together, Ross, is once again part of our mission. We want to make and we want to offer a solution that will make sleep simple and where physicians and patients can realize they have a safe solution that will be effective regardless of their sleep and that can mimic in fact a natural night sleep. Speaker 800:34:36Great. Thank you. Operator00:34:39One moment for the next question. The next question comes from David Rescott with Baird. Your line is now open. Speaker 800:34:51Great. Thanks for taking the questions here and congrats on the progress so far this year. I wanted to start on Germany. I want to make sure I heard a couple of things correct. For the full year in the U. Speaker 800:35:04S. Is at 27 percent share, closer to 50% in the 4th quarter. Wondering if you have a sense for the number of centers that you're in today and then whether or not or just any more color on the progress with the partnership you have with ResMed out there? Then I have a follow-up. Speaker 200:35:23Yes. No, no, definitely. So first of all, today, you are correct in understanding the 27% share for the total year in 2023. And today, we can say that we have 51 centers that are fully trained and ready to implant and or implanting the Genio technology. So 51, that's where we stand today. Speaker 200:35:46When it comes to our ResMed partnership, our main goal to the partnership is further developing a patient centric approach by developing a complete OSA ecosystem where patients can be guided to whichever OSA therapy best suits their needs. We are collaborating on DTC initiatives and sales and marketing efforts to target both suite physicians and ENT surgeons. The goal of the partnership are to expand OSA therapy penetration and, of course, to increase our market share in Germany. Speaker 800:36:22Okay, great. I want to ask maybe about some of the commercialization thoughts, high level thoughts in the U. S, if I heard you correctly. I think you're looking to bring on 25 dedicated U. S. Speaker 800:36:36Salespeople. And just wondering what you think the addressable or the immediate opportunity for those salespeople could be meaning if we're modeling 200 centers or so coming online with about 1 implant per center per month, can the 25 sales reps you initially have in 2025 expand that level or support that level of growth? Or do you need to continually add as you get into 2025 to 26? Thank you. Speaker 200:37:07No, no, Ananda. It's a very valid question. I can tell you it's also a question that keeps us busy internally and defining and see how we can make the most successful launch going forward. Now as I mentioned, we will start with a laser focused launch on top 8. Just to provide you some color, we are not going after 200 accounts from the get go for a simple reason that we want to ensure high implant quality and therefore we need to train the surgeons in a quality way. Speaker 200:37:38Of course, also being time conscious, but we have to put the quality always first because we want to have our first patients also showing the success that we see in our clinical data. So that's number 1. So it will not be 200 accounts, but more 75 to 100 accounts. And when we go a little bit more in-depth, how do we define our launch success? I mean, there are a couple of parameters. Speaker 200:38:03First is breaking the monopoly that currently is existing when it comes to AG and S in the U. S. And expanding the AG and S market. That is one of our strategy. Next, of course, we want to exceed the Street expectations. Speaker 200:38:17And 3rd, we want to make sure that we can extend our cash runway to mid-twenty 6 with a focused and scalable commercialization strategy. I think those three things are extremely important. So you can expect that the 25 salespeople will all have 4 to 5 implant accounts from the gate go and that we expect every account to do minimum an implant a week, if not 2 implants a week, so that we can then you can start modeling notes in your model. Speaker 800:38:46All right. That's very helpful. Thanks so much. Operator00:38:50And our last question will come from Michael Polarc with Wolfe Research. Your line is now open. Speaker 500:39:00Good afternoon, good evening. Speaker 400:39:02I'm curious, is Doctor. Boone on the call? Speaker 200:39:05He's not on this call. He just started, but he will be on the next call, Mike. He can be sure and there will also be opportunities when we will host the Investor and Analyst Day that you can talk extensively to him or with him. Speaker 500:39:17Okay. Sounds good. We'll leave that for then. I did have one other personnel question. I noticed Christoph Eigenmann left the company, the Chief Commercial Officer you hired last year. Speaker 500:39:29And I'm just curious what happened there and kind of what is the plan for U. S. Sales leadership? It sounds like you're moving forward with hiring a field force, but I'm curious if you plan to backfill for Christophe? And if so, where is that process? Speaker 500:39:45And what kind of characteristics are you looking for in a candidate? Speaker 200:39:49Yes, Monu and definitely. So first of all, I will not comment too much because out of respect also for Christophe when he was joining us who really, really worked hard and did a good job. But sometimes it's not that easy to really make a transfer from a large company into a startup company where we are because there are totally different expectations. And I do think that it was the best solution for both Christophe and IXORA to explore other opportunities and to have our ways separating. Now that being said, it illustrated again for us how careful we have to be in this recruitment process and how we in fact also incorporate the learnings to find, I call it, the unicorn leaders that the U. Speaker 200:40:35S. Market deserves and that also the U. S. Team now deserves to have a successful launch. So the process is ongoing. Speaker 200:40:43We have several candidates that we met. We are now having a short list. And together with our Board and also with some other members of our team, including Doctor. Boone, we will be shortly announcing our new CCO and then also help us prepare the U. S. Speaker 200:40:59Launch. Speaker 600:41:02TheRead morePowered by Conference Call Audio Live Call not available Earnings Conference CallNyxoah Q1 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K) Nyxoah Earnings HeadlinesINVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Nyxoah S.A. - NYXHApril 22 at 3:58 PM | prnewswire.comNyxoah (NASDAQ:NYXH) Price Target Lowered to $14.00 at Stifel NicolausApril 22 at 2:55 AM | americanbankingnews.comWhat President Trump’s Executive Order 14154 means for your moneyNearly $3 trillion disappeared from the stock market on Thursday morning. According to Whitney Tilson - a former hedge fund manager who predicted the dotcom crash, the housing crisis, and the 2022 tech stock bloodbath - a little-known executive order from the President's first day in office could spark a paradigm-shift that will likely catch millions of Americans off guard.April 24, 2025 | Stansberry Research (Ad)Conditional Issuance of SharesApril 16, 2025 | globenewswire.comINVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Nyxoah S.A. - NYXHApril 14, 2025 | prnewswire.comBronstein, Gewirtz & Grossman, LLC Is Investigating Nyxoah S.A. (NYXH) And Encourages Investors to ConnectApril 13, 2025 | markets.businessinsider.comSee More Nyxoah Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Nyxoah? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Nyxoah and other key companies, straight to your email. Email Address About NyxoahNyxoah (NASDAQ:NYXH), a medical technology company, focuses on the development and commercialization of solutions to treat sleep disordered breathing conditions. The company's lead solution comprises Genio system, a CE-Marked, patient-centric, and hypoglossal neurostimulation therapy to treat moderate to severe obstructive sleep apnea. 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There are 9 speakers on the call. Operator00:00:00Ladies and gentlemen, thank you for standing by. Welcome to the Nixo First Quarter 20 24 Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference call is being recorded. Operator00:00:34I would like now to turn the conference over to Mikaela Kirkwood, Investor Relations and Communications Manager. Please go ahead. Speaker 100:00:45Good afternoon and good evening, everyone, and welcome to our earnings call for the Q1 of 2024. I am Mikaela Kirkwood, Investor Relations and Communications Manager at NextElla. Participating from the company today will be Olivier Tillman, Chief Executive Officer and Lalique Moreau, Chief Financial Officer. During the call, we will discuss our operating activities and review our Q1 financial results released after U. S. Speaker 100:01:10Markets closed 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 of the Investor Relations tab of our website. Before we begin, I would like to remind you that any statements that relate to expectations or predictions of future events, market trends, results or performance are forward looking statements. All forward looking statements are based upon our current estimates and various assumptions. Speaker 100:01:43These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward looking statements. All forward looking statements are based upon current available information and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these statements. For a listen description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 20 F filed with the Securities and Exchange Commission on March 20, 2024. With that, I will now turn the call over to Olivier. Speaker 200:02:23Thank you, Mikaela. Good afternoon and good evening, everyone, and thank you for joining us for our Q1 2024 earnings call. 2024 has been transformational for NKTROVA. In March, we announced our DREAM U. S. Speaker 200:02:39Pivotal study achieved its primary endpoints and demonstrated that Jynneo has the potential for best in class outcomes for OSA patients. I would like to congratulate our clinical team on these terrific results. Our regulatory team is working diligently to file the 4th and final module in our modular PMA submission this quarter, which will set the stage for entering the U. S. Market upon FDA approval as early as the end of 2024. Speaker 200:03:11Additionally, Doctor. Moritz Boone, one of the pioneers in hypoglossal neurostimulation, joined us from Thomas Jefferson University as Chief Medical Officer, and we announced a partnership with the American Association of Otolaryngology at the Neck Surgery Foundation to drive Medicare and commercial payer coverage. Commercially, we reported 1st quarter sales of €1,200,000 almost tripling revenue from the Q1 of 2023 and benefiting from our focused approach on strengthening collaboration between implant surgeons and referring sleep physicians. To recap DREAM, the study had co primary endpoints of AHI responder rate per the share criteria at 12 months and ODI responder rate at 12 months. At baseline, subjects had a mean AHI of 28.0, ODI of 27.0 and a body mass index of 28.5. Speaker 200:04:17On an intent to treat or ITT basis, DREAM study showed an AHI responder rate of 63.5 percent with a p value of 0.002 and an ODI responder rate of 71.3% with a p value less than 0.001. With these strong results, the DREAM study met its primary endpoints. Additionally, subjects demonstrated a median 12 month AHI reduction of 70.8% with similar AHI improvements in supine and nonsuppine sleeping positions. The safety results were favorable with 11 serious adverse events of SAEs in 10 subjects resulting in an SAE rate of 8.7%. Out of the 11 SAEs, 3 were device related and there were 3 explants. Speaker 200:05:24The DREAM results further differentiate Genio as it was the first AGNS study to require patients to sleep at least 60 minutes in the supine position and demonstrated strong efficacy with patients sleeping supine and non supine. This is of particular importance since published data show increased OSA severity in the supine position, with AHI doubling in the supine versus the lateral position. On average, people sleep 35% to 40% in a supine position during a standard night, which was in line with our PSG findings in DREAM. This means that irrespective of a patient's sleeping position, Jynio maintains its efficacy. Based on early feedback from the physicians, this can be very impactful on therapy selection. Speaker 200:06:20It supports our mission to make sleep simple again, and we intend to apply for the inclusion of supine efficacy results in our label. With the positive DREAM results, we are now finalizing our modular PMA submission. We have responded to the FDA questions on the first three modules and are in an interactive review and anticipate filing the 4th and final module this quarter. We are preparing for a launch by the end of 2024 as based upon modular PMA review cycle times. We anticipate FDA approval of late 24 or early 25 as we do not control FDA time lines. Speaker 200:07:02In parallel, we continue making progress on the reimbursement side as we are establishing reimbursement pathways with commercial payers, Medicare and Medicaid. The reimbursement team is working closely with the AAO and reimbursement experts to secure coverage at FDA approval. Ahead of approval, we will be conducting a payer feedback interview with the former CMS and Commercial Plan Medical Director as well as participate in the early payer feedback program for the FDA designed to provide direct feedback for major payers such as UnitedHealthcare, Blue Cross Blue Shield, Aetna as well as CMS. Upon commercialization, we will have a prior authorization team in place to assist with claims submission and payment. Our U. Speaker 200:07:59S. Focus is significantly increasing, highlighted by the recent addition of Doctor. Mo Boon as Chief Medical Officer. Doctor. Boon, who joins Nyxoah from Thomas Jefferson University, is internationally recognized as one of the most experienced surgeons in the field of OSA and AGLS. Speaker 200:08:21Being able to have such high caliber talent joining Nyxoah is a strong validation of the opportunity for Genio to disrupt the OSA market. We are actively building our U. S. Commercialization team to be ready to launch by the end of this year. The current AGNS market in the U. Speaker 200:08:42S. Is very concentrated, allowing for a laser focused launch, breaking the current monopoly with ERT sites, while establishing a patient referral pathway from sleep specialists. As part of FDA approval process, we have a usability study with 31 physicians that are the top AGNS implanters in the U. S, and their feedback was overwhelmingly positive. Providing a little more color on the usability study. Speaker 200:09:18Naive surgeons, meaning surgeons without experience with Jynneo, were invited to participate in a training session to unaudibly and safely use the device. The training contained theoretical session followed by both animal and cadaver implants. 12 hours later, mimicking a real ORF setting, surgeons had to repeat the implant without guidance to demonstrate they've properly retained the knowledge on device programming and acquire the implantation technique, always ensuring patient safety and comfort during the procedure. These surgeons were adamant. They want to be the 1st Genio implanters in their areas and convinced of the differentiation of GenioVest's current AGNS technology in terms of invasiveness, patient centricity, safety and the simplicity to treat OSA patients regardless of their sleeping position. Speaker 200:10:22In addition, a recent independent survey demonstrated that over 20% of U. S. AGNS candidates are declining a pacemaker based platform technology due to their concerns over the invasiveness and having implantable battery in the chest. Going back to Europe, 1st quarter sales was €1,200,000 an increase of 177% of the Q1 of 2023. As part of our commercialization of commercial proof of concept in Germany, we see that, 1st, the majority of accounts became mixed implanting accounts embracing Genio in their practice. Speaker 200:11:092nd, parity penetration is strongly accelerating as a result of Jynneo entering the market as a new player. And 3rd, there is a large pool of CPAP quitting patients in need for treatment, which can be addressed through establishing a strong collaboration between implanting surgeons and referral sleep physicians, highlighted by our ResMed collaboration. In summary, we started 2024 strongly by reporting positive DREAM data, further disconcerting Jynneo with our unique supine dip. For the remainder of the year, we are working towards FDA approval by the end of the year and commercial readiness for a strong U. S. Speaker 200:11:56Launch in 2025. With that, I'm pleased to turn the call over to our CFO, Louis Morreau, who will provide a financial update. Speaker 300:12:08Thank you, Olivier. Good day to everyone and thank you for joining us today. Revenue for the Q1 ended March 31, 2024 was €1,200,000 a 177% increase over the Q1 of 2023. Total operating loss for the Q1 was €12,200,000 versus €11,400,000 in the Q1 of 2023, driven by an acceleration in commercial investments in the U. S. Speaker 300:12:42As well as in Europe. As of March 31, 2024, cash and financial assets totaled €44,300,000 compared to €57,700,000 on December 31, 2023. During the Q1, our monthly cash burn was €4,500,000 Based on our current cash position, we have a runway into late 2024, which includes the building of the U. S. Commercial team. Speaker 300:13:17This concludes the formal part of our presentation. Operator, I will turn the call over to you to begin our Q and A session. Operator00:13:27Thank you. The first question comes from Jon Block with Stifel. Your line is now open. Speaker 400:13:57Thanks. Good afternoon. First question, Olivier, just any details on where market share shook out in 2023 for Genio in Germany? And your thoughts on 2024? And then part 2 of that first question would just be the burn rate that we can expect as you ramp up the commercialization efforts in the coming months? Speaker 400:14:21I think headcount and prepping for launch, as you mentioned, by potentially Speaker 500:14:27the end of this year, Speaker 400:14:27Q4 of 2024? And then I'll ask my follow-up. Thanks, guys. Speaker 200:14:33Thank you. So, John, first of all, thank you for the questions. Looking back at 2023 and the annual market share, we ended up with 27% overall market share and we had a very strong Q4 close in 2023, bringing the market share close to 50%. So that was, I think, the first part of your question. The second part was Speaker 400:14:59Just how we should view the I'm sorry, how we should view whether you want to do monthly burn or quarterly burn as you ramp up some of the commercialization efforts to prepare by launch Speaker 500:15:08by the end of this year? Speaker 300:15:12So we burned EUR 4,500,000 in Q1. We expect the burn rate to remain steady for the first half of the year and then begin to ramp up in the second half as we accelerate investments in the U. S. Commercial organization. We as we said, we have cash until late 2024 and that includes the build of the U. Speaker 300:15:34S. Commercial team. Speaker 400:15:38Okay. Got that. And if I have any additional questions there, I'll clarify offline. I think just to pivot for the second question, post the release of the DREAM top line data, we performed checks among 30 physicians and asked them how they view the DREAM data relative to superior Speaker 600:15:58and Speaker 400:16:01about 17% saying, superior and about 17% saying inferior. So painting it with a broad brush, largely equivalent. Here we are just almost 2 months removed from the top line data being released Olivier. And I'm curious if maybe you can talk about what you've heard or others at Nexo have heard from the docs and maybe the reaction in the marketplace to the data, that'd be very helpful. Speaker 200:16:28Yes. No, no, definitely, John. And I also thank you for the work that you did on gathering this data. So let me, 1st of all, remind you that the study was not designed for a head to head comparison. There are a few different characteristics making DREAM more challenging than stores. Speaker 200:16:46To name the most important one is having minimum 60 minutes supine sleep for all our patients in order to qualify as a responder. And there is also the broader AHI range, where in DREAM you have a range between 15% to 65%, where in store the range was 20 to 50. Now that being said, of course, I fully understand the nature of the question. I also fully understand why physicians and other people are looking how to compare these data. So our AHI and ODI respond rates are in line with our competitors' study starts, calculated on a 10 to 3 basis and our median AHI reduction is even slightly higher. Speaker 200:17:30In general, as physicians are well aware of, it's harder to control OSA when patients are supine compared to non supine because it's more difficult to maintain an open airway in a supine position, mainly driven by gravity. While we plan to hold the data for publication, I can already comment that Ingenio showed similar AHI reductions in both supine and non supine positions, while requiring patients to sleep supine may dream more challenging. The data provides evidence that Jynneo will be able to control patients' OSA regardless of their sleeping position. And I do think and this is also the feedback that we are getting when we are talking more in-depth with physicians and also know that we have Doctor. Bolan Bocht explaining it even better than I can to other physicians. Speaker 200:18:18We see that this is really perceived as a really, really differentiating factor, making the choice for the physician simpler because they do not need to worry whether the patient is sleeping supine or non supine knowing that in data 35% to 40% of a normal standard night, people are sleeping on their backs. So I do think that the supine data aspect is really differentiating Genio from STORE and it's also differentiating and showing a stronger efficacy in the specific supine position, which we like to say and claim that this is showing a superiority compared to what was demonstrated in the STORES trial. Speaker 400:19:01Very helpful. Thanks guys. Operator00:19:04One moment for the next question. The next question comes from Suraj Kalia with Oppenheimer. Your line is open. Speaker 600:19:16Good afternoon, Olivier, Louis. Can you hear me all right? Speaker 200:19:19Yes, we can. Hello. Speaker 600:19:22So Olivier, congrats on all the progress. Olivier, just piggybacking on your comments about supine, right? Obviously, that peaked everyone's curiosity. And my first question is a multipart question, if I could. How is the debate on hypoglycinnervestem efficacy supine, non supine? Speaker 600:19:45How is it growing in the field? And also recently, there was an Inspire paper that was talking about decreased efficacy in supine position. Olivier, forgive me. Olivier, if you look at one of the arguments made is, well, the titration is done in supine position. So this whole debate becomes moot. Speaker 600:20:13I'd love to have your take on this. When is the titration really done? Is it supine, non supine? If you could shed some color there and also the implications for a label, if really the titration is done in a supine position? Sorry, it was a multipart question. Speaker 600:20:33Hopefully, you got the gist of it. Speaker 200:20:35I hope I will be very complete in my answer, Suraj. But let me start a little bit the first part. So yes, this supine versus non supine is also creating a lot of further discussion within the ENT sleep surgeons community for the simple reason that when surgeons are deciding to choose for lithography, it's really important that they try to keep it as simple as possible. And knowing that you have the same OSA of the same airway opening in both supine and non supine position is definitely an advantage. So that being said, if we look at published data showing that 35% to 40% of the time people are sleeping in a supine position, you understand why this is becoming extremely important. Speaker 200:21:23On top, we also know that when a patient moves and turns into a supine position that AHI is twice as high when they are occupying versus when they are non supine. There were even patients who are not suffering from moderate oxyveer OSA when they are non supine and become a severe OSA patient once they turn supine. So again, an illustration how important it is to have a technology that can guarantee that the airway is opening or stays open during supine sleep position. Now at this moment, DREAM is the only study to require patients to sleep minimum 60 minutes supine at a 12 month follow-up visit, and this result showed similar AHI reductions compared to STOR. However, for Jynneo, it did not matter whether patients were sleeping supine or nonsuppine. Speaker 200:22:19STORE did not have a requirement to sleep supine at the 12 month visit and has not presented any data on supine efficacy from the study in the SORC trial. And that brings me to your next question. Recently, there was a publication done by INSPIRE on supine data. We have disclosed in dream that our median AHI reduction in supine and non supine sleeping positions were similar, implying around 70% in supine. If you compare the 70% that we showed to the 51% supine 1,000,000 AHI reduction reported in the recent publication. Speaker 200:23:00Based on this, I hope you agree with me that I can conclude that Jynneo has a superior outcome in a supine position. Have I completed my explanation? Or am I missing still something? Speaker 600:23:16No, sorry. It was a multi part. I mean, the titration part, Olivier, one of the arguments as well, the titration for hypoglycinergicym is done essentially in supine position. So it should not matter the supine, non supine. In all honesty, I never thought about at what point is the titration done? Speaker 600:23:39And I'd love to get some clarity on how is titration done for Genio? Speaker 200:23:46Yes. So let me start by first commenting on the fact titration is done in a supine position. So this is not the case for Genio. But if we just stay on the topic that titration is done for supine position, it would also implies that there is an overtitration in a non supine position. And we all know how sensitive patients can be for stimulation. Speaker 200:24:12The last thing we want to do is wake them up. So I do think it's important that the patient will get the adequate stimulation. And therefore, again, with our bilateral stimulation that we can offer and the way we do this on a tailor made based studying the PSG exam and pre programming. For activationship, we can offer a solution where we stimulate precisely for the patient in function of his or her needs to maintain the airway open. To that extent, knowing that we have similar airway opening effects using the same stimulation parameters, supine and non supine, this is again a great advantage that we offer and that we can contribute completely on the fact that we have a bilateral stimulation. Speaker 600:25:01Got it. And Olivier, for my follow-up question, if I could. I presume the label discussions start in Q3, I'm guessing. And also the 31 physicians, high volume Inspire docs that you all are considering presumably as low hanging fruit and preaching the virtues of Genio. I'd love to understand how you all are sensing the choice of device is going to shape up once you all become commercial? Speaker 600:25:32Gentlemen, congrats on the progress and thank you for taking my questions. Speaker 200:25:36Well, thank you for the question, Surajan. And again, to your point, we also start opening the label discussion that is part of our module 4 submission. So that is what we will bring in. And based on our data, we will really pursue the option to have the supine position really explicit in our label. And I think based on this, and I'm coming back to our mission, and that is making sleep simple again, based on this, for a physician, it becomes obvious working with Genio, you know that you don't need to worry too much and that you can always maintain the airway of patients open regardless of their sleep position. Speaker 200:26:14And that is really, really the clear concept. Operator00:26:20One moment for the next question. Our next question comes from Adam Meter with Piper Sandler. Your line is open. Speaker 700:26:33Hi, good evening guys. Thank you for taking the questions and congrats on the progress. I wanted to start by asking about some of the preparations that you're making from a sales force and manufacturing standpoint. If I heard some of the remarks correctly, it sounds like that's the onboarding of sales U. S. Speaker 700:26:53Sales folks is more back half loaded. But I was hoping you could get a little bit more granular there. So how many U. S. Sales reps have you hired at the moment? Speaker 700:27:04Kind of how should we think about that building in the back half of the year? Where do you expect to be at launch? And then I guess kind of a similar question, just talk about manufacturing capabilities and capacity and how you feel about that going into U. S. Launch at the end of the year? Speaker 700:27:21And then I had a follow-up. Thanks. Speaker 200:27:23Yes. Well, thank you, Adam, for the question. So when we look at our launch strategy, as I mentioned earlier in the call, it's clear that currently AGNS in the U. S. Is a very concentrated business. Speaker 200:27:35So it allows us to have a laser focused launch on top AGNs, which constitute the vast majority of implants. Next to this, we want to develop relationship with key sleep centers to drive referrals. So limited and efficient sales force sized appropriately for a targeted launch, which we can scale them opportunistically over time. Being very concrete, we plan to launch with a sales team of around 25 people being laser focused on those top AGI cytokines. Now the scalability, patient follow-up strategy, which includes field clinical engineers to monitor implants and patient management specialists to focus on titration and patient follow-up. Speaker 200:28:17This increases the sales force capacity as sales reps can focus on lead generation and can also focus on what they are hired for and that is increasing sales. There will be a limited DTC focus on product differentiation, of course. And on top of this, we also will have a trial authorization team in place at launch. Now how will we differentiate and how will we break the monopoly and take share from the competition? A, we will focus on our superior efficacy due to the supine AHI reduction. Speaker 200:28:51I think I already was pretty clear about this. And B, we will have our product differentiation, no implantable post generation, implant for life, fully scalability of our technology, a single incision, no leads, no risk for lead breakage. So those 2 will be our key factors that we will use within our sales force. The superior efficacy based on supine HII reduction and product differentiation making sleep center again. Speaker 700:29:23That's good color, Olivier. And just from a manufacturing standpoint, I don't think we need to spend too much time here, but just wanted to ask I'd check if you guys are indeed feeling good about the ability to manufacture and hit the ground running in 'twenty five in the U. S? Speaker 300:29:39And then Speaker 600:29:40I had one follow-up. Thanks. Speaker 200:29:41Yes. Go ahead. So for the U. S. Sales specifically, we have contracted with a leading U. Speaker 200:29:47S. Medical device manufacturer. And so eventually also the same as competition is using that will provide systems for the U. S. Market at the first stage. Speaker 200:29:58Currently, we are having our Belgium manufacturing sites for European commercial supply that will be further extended to also be able to supply for the U. S. And we are keeping our historical manufacturing facilities in Tel Aviv for clinical trial inventory. The manufacturing lines are highly scalable, particularly as we will launch with a ceramic encapsulation version of Jynio, which is easier and less expensive to manufacture. Speaker 700:30:27Yes. Good color there Olivier. Thank you for that. And for the follow-up, I wanted to switch over to reimbursement and ask for more color about the strategic partnership with AAO, HNSF. What more can you tell us about kind of the background of that agreement or the genesis of the agreement? Speaker 700:30:47And then I'll also ask any update in terms of how we're thinking about coding vehicle for Genio in the U. S. And just pace of payer coverage in the United States? It sounds like you expect U. S. Speaker 700:31:00Payers to come on pretty quickly after approval, but maybe just talk about the confidence there. And thank you for taking Speaker 200:31:08the questions. Yes. No, no, definitely. So we have partnered with AAO, which will make a formal recommendation on an interim CPT code for use for us to use at launch, directly at launch when we have obtained FDA approval. At launch, doctors will submit Medicare claims using the AAO recommended CPT code, which will closely match the Jynneo procedures and is currently covered by all Medicare Administrative Contractors or MACs. Speaker 200:31:40The reimbursement will be in line with current AGNS payment rates, and I think that's also important. We will pursue a Genio specific CPT code over time, but based upon precedent, this will likely take a couple of years. Now in going forward, we know that all the MACs have local coverage decisions for AGNS. And in collaboration with them, we will have limited coverage optical from Genio that will leverage those decisions. We have the full influence and support of the AEO for our strategy demonstrated in their recent partnership. Operator00:32:26The next question comes from Ross Osborne with Cantor Fitzgerald. Your line is open. Speaker 800:32:33Hey, guys. Thanks for taking our questions. Maybe just one for me. I would be curious to hear if there's any update on the ACCESS trial? And then how you think education efforts will progress post data there in the U. Speaker 800:32:46S. In terms of being able to utilize your offering with CCC patients, which historically has not been done? Thank you. Speaker 200:32:54Thank you, Rolf and thank you for the question. So we continue to make progress with the ACCESS study. But as I mentioned before, we will not be disclosing the number of patients implanted. That said, we still plan to close implant by the end of this year, by the end of 2024. Once we close the study, there will be a 12 month follow-up that will bring us to the end of 2025. Speaker 200:33:17Then we will file a P and A supplement. And therefore, we anticipate a 6 to 9 month review period. So we expect to receive a label expansion in mid-twenty 6. And I know this was not really the question, but I do think it's important also to strategically carve out. When I was talking about supine versus non supine, we're also looking in the remap non CCC patients. Speaker 200:33:41There, we are really making sleep simple again by physicians not having to worry about in what position people are sleeping. Now when you look at CCC patients versus non CCC, again, this is under the same umbrella in our strategy in making sleep simple again that all this time also physicians don't need to worry whether a patient is suffering from CCC or non CCC. Not to forget, this will also eliminate the currently in place to further determine whether a patient is a CCC or a non CCC patient. So all this together, Ross, is once again part of our mission. We want to make and we want to offer a solution that will make sleep simple and where physicians and patients can realize they have a safe solution that will be effective regardless of their sleep and that can mimic in fact a natural night sleep. Speaker 800:34:36Great. Thank you. Operator00:34:39One moment for the next question. The next question comes from David Rescott with Baird. Your line is now open. Speaker 800:34:51Great. Thanks for taking the questions here and congrats on the progress so far this year. I wanted to start on Germany. I want to make sure I heard a couple of things correct. For the full year in the U. Speaker 800:35:04S. Is at 27 percent share, closer to 50% in the 4th quarter. Wondering if you have a sense for the number of centers that you're in today and then whether or not or just any more color on the progress with the partnership you have with ResMed out there? Then I have a follow-up. Speaker 200:35:23Yes. No, no, definitely. So first of all, today, you are correct in understanding the 27% share for the total year in 2023. And today, we can say that we have 51 centers that are fully trained and ready to implant and or implanting the Genio technology. So 51, that's where we stand today. Speaker 200:35:46When it comes to our ResMed partnership, our main goal to the partnership is further developing a patient centric approach by developing a complete OSA ecosystem where patients can be guided to whichever OSA therapy best suits their needs. We are collaborating on DTC initiatives and sales and marketing efforts to target both suite physicians and ENT surgeons. The goal of the partnership are to expand OSA therapy penetration and, of course, to increase our market share in Germany. Speaker 800:36:22Okay, great. I want to ask maybe about some of the commercialization thoughts, high level thoughts in the U. S, if I heard you correctly. I think you're looking to bring on 25 dedicated U. S. Speaker 800:36:36Salespeople. And just wondering what you think the addressable or the immediate opportunity for those salespeople could be meaning if we're modeling 200 centers or so coming online with about 1 implant per center per month, can the 25 sales reps you initially have in 2025 expand that level or support that level of growth? Or do you need to continually add as you get into 2025 to 26? Thank you. Speaker 200:37:07No, no, Ananda. It's a very valid question. I can tell you it's also a question that keeps us busy internally and defining and see how we can make the most successful launch going forward. Now as I mentioned, we will start with a laser focused launch on top 8. Just to provide you some color, we are not going after 200 accounts from the get go for a simple reason that we want to ensure high implant quality and therefore we need to train the surgeons in a quality way. Speaker 200:37:38Of course, also being time conscious, but we have to put the quality always first because we want to have our first patients also showing the success that we see in our clinical data. So that's number 1. So it will not be 200 accounts, but more 75 to 100 accounts. And when we go a little bit more in-depth, how do we define our launch success? I mean, there are a couple of parameters. Speaker 200:38:03First is breaking the monopoly that currently is existing when it comes to AG and S in the U. S. And expanding the AG and S market. That is one of our strategy. Next, of course, we want to exceed the Street expectations. Speaker 200:38:17And 3rd, we want to make sure that we can extend our cash runway to mid-twenty 6 with a focused and scalable commercialization strategy. I think those three things are extremely important. So you can expect that the 25 salespeople will all have 4 to 5 implant accounts from the gate go and that we expect every account to do minimum an implant a week, if not 2 implants a week, so that we can then you can start modeling notes in your model. Speaker 800:38:46All right. That's very helpful. Thanks so much. Operator00:38:50And our last question will come from Michael Polarc with Wolfe Research. Your line is now open. Speaker 500:39:00Good afternoon, good evening. Speaker 400:39:02I'm curious, is Doctor. Boone on the call? Speaker 200:39:05He's not on this call. He just started, but he will be on the next call, Mike. He can be sure and there will also be opportunities when we will host the Investor and Analyst Day that you can talk extensively to him or with him. Speaker 500:39:17Okay. Sounds good. We'll leave that for then. I did have one other personnel question. I noticed Christoph Eigenmann left the company, the Chief Commercial Officer you hired last year. Speaker 500:39:29And I'm just curious what happened there and kind of what is the plan for U. S. Sales leadership? It sounds like you're moving forward with hiring a field force, but I'm curious if you plan to backfill for Christophe? And if so, where is that process? Speaker 500:39:45And what kind of characteristics are you looking for in a candidate? Speaker 200:39:49Yes, Monu and definitely. So first of all, I will not comment too much because out of respect also for Christophe when he was joining us who really, really worked hard and did a good job. But sometimes it's not that easy to really make a transfer from a large company into a startup company where we are because there are totally different expectations. And I do think that it was the best solution for both Christophe and IXORA to explore other opportunities and to have our ways separating. Now that being said, it illustrated again for us how careful we have to be in this recruitment process and how we in fact also incorporate the learnings to find, I call it, the unicorn leaders that the U. Speaker 200:40:35S. Market deserves and that also the U. S. Team now deserves to have a successful launch. So the process is ongoing. Speaker 200:40:43We have several candidates that we met. We are now having a short list. And together with our Board and also with some other members of our team, including Doctor. Boone, we will be shortly announcing our new CCO and then also help us prepare the U. S. Speaker 200:40:59Launch. Speaker 600:41:02TheRead morePowered by