Nyxoah SA

Ladies and gentlemen, thank you for standing by. Welcome to NXO first quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you would 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 11 again. please be advised that today's conference call is being recorded. I would like now to turn the conference over to Michaela Kirkwood, Investor Relations and Communications Manager. Please go ahead.

Good afternoon and good evening, everyone, and welcome to our earnings call for the first quarter of 2024. I am Michaela Kirkwood, Investor Relations and Communications Manager at NXOA. 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 first quarter of financial results released after U.S. markets 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. These statements involve material risks and uncertainties that could cause actual results or events to material 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 lessened description of the risks and uncertainties associated with their 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.

Thank you, Michaela.

Good afternoon and good evening everyone and thank you for joining us for our first quarter 2024 turnings call. 2024 has been transformational for Nixoa. In March we announced our dream US pivotal study achieved its primary endpoints and demonstrated that Genio has the potential for best in class outcomes for OSA patients. I would like to congratulate our clinical team on these terrific results. Our regulatory team is working diligently to file the fourth and final module in our Modular PMA Submission Disc Order, which will set the stage for entering the US market upon FDA approval as early as the end of 2024. Additionally, Dr. Moritz Boone, one of the pioneers in hypoglossal nerve stimulation, joined us from Thomas Jefferson University as chief medical officer, and we announced a partnership with the American Association of Otolaryngology at the Neck Surgery Foundation to drive Medicare and commercial payer coverage. Commercially, we reported first quarter sales of 1.2 million euros, almost tripling revenue from the first quarter of 2023 and benefiting from our focused approach on strengthening collaboration between implant surgeons and referring sleep physicians. To recap DREAM, the study had co-primary endpoints of AHI responder rate per the shared criteria at 12 months and ODI responder rate at 12 months. At baseline, subjects had a mean AHI of 28.0 ODI of 27.0 and a body mass index of 28.5. On an intent to treat or ITT basis, DREAM study showed an AHI responder rate of 63.5% with a p-value of 0.002 and an ODI responder rate of 71.3% with a p-value less With these strong results, the DREAM study met its primary endpoints. Additionally, subjects demonstrated a median 12-month AHI reduction of 70.8%, with similar AHI improvements in supine and non-supine sleeping positions. The safety results were favorable. with 11 serious adverse events, or SAEs, in 10 subjects, resulting in an SAE rate of 8.7%. Out of the 11 SAEs, three were device-related, and there were three explants. The DREAM results further differentiate Genio, as it was the first 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, Genio maintains its efficacy. Based on early feedback from the physicians, this can be very impactful on therapy selection. It supports our mission to make sleep simple again, and we intend to apply for the inclusion of supine efficacy results in our label. With the positive DREAM results, we are now finalizing our modeler PMA submission. We have responded to the FDA questions on the first three modules and are in an interactive review and anticipate filing the fourth and final module this quarter. We are preparing for a launch by the end of 2024 as based upon modular PMA review cycle plans. We anticipate FDA approval in late 2024 or early 2025 as we do not control FDA timelines. In parallel, We continue making progress on the reimbursement site as we are establishing reimbursement pathways with commercial payers, Medicare and Medicaid. The reimbursement team is working closely with the AIO and reimbursement experts to secure coverage at FDA approval. Ahead of approval, we will be conducting a payer feedback interview with the former CMS and Commercial Plan Medical Director as well as participate in the early payer feedback program for the FDA, designed to provide direct feedback from major payers, such as UnitedHealthcare, Blue Cross Blue Shield, Aetna, as well as CMS. Upon commercialization, we will have a prior authorization team in place to assist with claims submission and payment. Our U.S. focus is significantly increasing, highlighted by the recent addition of Dr. Mo Boon as Chief Medical Officer. Dr. Boon, who joined NCSOA from Thomas Jefferson University, is internationally recognized as one of the most experienced surgeons in the field of OSA and AGLS. Being able to have such high caliber talent Joining Nixoa is a strong validation of the opportunity for Genio to disrupt the OSA market. We are actively building our US commercialization team to be ready to launch by the end of this year. The current AGNS market in the US is very concentrated, allowing for a laser-focused breaking the current monopoly with EMT sites while establishing a patient referral pathway from sleep specialists. As part of FDA approval process, we ran a usability study with 31 physicians that are the top AGNS implanters in the US, and their feedback was overwhelmingly positive. Providing a little more color on the usability study, Naive surgeons, meaning surgeons without experience with Genio, were invited to participate in a training session on how to safely use the device. The training contained theoretical sessions followed by both animal and cadaver implants. Twelve hours later, mimicking a real OR setting, surgeons had to repeat the implant without guidance to demonstrate they properly retain 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 first Genio implanters in their areas and convinced of the differentiation of Genio versus current AGNS technology in terms of invasiveness, patient-centricity, safety, and the simplicity to treat OSA patients regardless of their sleeping position. In addition, a recent independent survey demonstrated that over 20% of USAGNS candidates are declining a pacemaker-based platform technology due to their concerns over the invasiveness and having implantable battery in the chest. Going back to Europe, first quarter sales was 1.2 million euros, an increase of 177% of the first quarter of 2023. As part of our commercialization of commercial proof of concept in Germany, we see that first, the majority of accounts became mixed implanting accounts, embracing Genio in their practice. therapy penetration is strongly accelerating as a result of Genio entering the market as a new player. And third, there is a large pool of CPAP quitting patients in need for treatment, which can be addressed through establishing a strong collaboration between implanting surgeons and referral sleep physicians, highlighted by our ResMed collaboration. In summary, We started 2024 strongly by reporting positive dream data, further differentiating Genio with our unique supine list. For the remainder of the year, we are working towards FDA approval by the end of the year and commercial readiness for a strong US launch in 2025. With that, I'm pleased to turn the call over to our CFO, Louis Moreau, who will provide a financial update.

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

Thank you. As a reminder, to ask a question, please press star. Excuse me. Please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. The first question comes from John Block with Stiefel. Your line is now open.

Thanks. 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 two of that first question would just be, you know, the burden rate that we can expect as you ramp up the commercialization efforts in the coming months, I think, you know, headcount and prepping for launch, as you mentioned, by potentially the end of this year, fourth quarter of

2024 and then I'll ask my follow-up thanks guys thank you so John first of all thank you for the questions looking back at 2023 and the annual market share we ended up with 27 percent overall market share and we had a very strong Q4 closed in 2023 bringing the market share close to 50 percent that was I think the first part of your question the second part was

Just 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 by the end of this year.

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

Okay. Got that. And if I have any additional questions there, I'll clarify offline. I think just to pivot for the second question, you know, post the release of the DREAM top line data, we perform checks among 30 physicians and ask them how they view The dream data relative to INSPIRE's STAR, and, you know, I sort of categorize the findings as upbeat. The majority of you dream as equivalent to STAR. There was about 20% saying superior and about 17% saying inferior. So, you know, painting it with a broad brush, largely equivalent. Here we are just almost two 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 NXO have heard from the docs and maybe the reaction in the marketplace to the data, that'd be very helpful.

No, no, definitely, John. And I also thank you for the work that you did on gathering this data. Now, let me first of all remind you that the study was not designed for a head-to-head comparison. There are a few different characteristics making DREAM more challenging than STORS. To name the most important one is having minimum 60 minutes supine sleep for all our patients in order to qualify as a responder. And there is also the broader AHI range, where in DREAM you have a range between 15 to 65, where in STAR 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 an intent-to-treat basis, and our median AHI reduction is even slightly higher. In general, as physicians are well aware of, it's harder to control OSA when patients are supine compared to non-supine because it's more difficult to maintain an open airway in a supine position, mainly driven by gravity. While we plan to hold the data for publication, I can already comment that Genio showed similar AHI reductions in both supine and non-supine positions. While requiring patients to sleep supine may dream more challenging, the data provides evidence that Genio will be able to control patients' OSA regardless of their sleeping position. And I do think, and this is also the feedback that we are getting when we are talking more in-depth with physicians and also know that we have Dr. Boon on board explaining it even better than I can to other physicians, we see that this is really perceived as a really, really differentiating factor making the choice for a physician because they do not need to worry whether the patient is sleeping supine or non-supine, knowing that in data, 35 to 40% of normal standard night, people are sleeping on their back. So I do think that the supine data aspect is really differentiating Genio from Storr, 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 source file.

Very helpful. Thanks, guys.

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

Good afternoon, Olivier. Can you hear me all right?

Yes, we can. Hello.

So, Olivier, congrats on all the progress. Olivier, just briefly, piggybacking on your comments about supine, right? Obviously, that piqued everyone's curiosity. And my first question is a multi-part question, if I could. How is the debate on hypoglossal nerve stem efficacy, supine, non-supine, how is it brewing in the field? And also recently, there was an Inspire paper that was talking about decreased efficacy in supine position yes forgive me olivia if you look at you know one of the arguments made is well the titration is done in supine position so this whole debate becomes mood i'd love to have your uh take on this uh when is the titration really done is it supine non-supine If you could shed some color there, and also the implications for a label, if really the titration is done in a supine position. Sorry, it was a multi-part question. Hopefully, you got the gist of it.

I hope I will be very complete in my answer, but let me start with the first part. So, yes, this supine versus non-supine is also creating a lot of further discussion within the EMT sleep surgeons. community for a simple reason that when surgeons are deciding to choose for a therapy, it's really important that they try to keep it as simple as possible and knowing that you have the same OSA 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. On top, we also know that when a patient moves and turns into a supine position, that AHI is twice as high when they are supine versus when they are non-supine. There are even patients who are not suffering from moderate or severe OSA when they are non-supine and become a severe OSA patient once they turn supine. So again, an illustration of how important it is to have a technology that can guarantee that the airway is opening or stays open during a supine sleep position. Now, at this moment, DREAM is the only study to require patients to sleep minimum 60 minutes supine at a 12-month follow-up visit And this result showed similar AHI reductions compared to STAR. However, for Genio, it did not matter whether patients were sleeping supine or non-supine. STAR did not have a requirement to sleep supine at a 12-month visit and has not presented any data on supine efficacy from the study in the STAR trial. 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 median AHI reduction reported in the recent publication, based on this, I hope you agree with me that I can conclude that Genio has a superior outcome in the supine position. Was I complete in my explanation, or am I missing still something?

No, sorry, it was a multi... I mean...

The titration part, Olivier, one of the arguments is, well, the titration for hypoglossal nerve stem is done essentially in supine position. So it should not matter the supine, non-supine. You know, in all honesty, I never thought about at what point is the titration done. And I'd love to get some clarity on how is titration done for Genio?

Yes. Now, let me start by first commenting on the fact that titration is done in a supine position. So this is not the case for GMO. But if we just stay on the topic that titration is done for a supine position, it would also imply that there is an over-titration in a non-supine position. And we all know how sensitive patients can be. for stimulation. The last thing we want to do is wake them up. So I do think it's important that 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 base, studying the PSG exam and pre-programming or activation chip, we can offer a solution where we stimulate precisely for a patient in function of his or her needs to maintain the airway open. To that extent, knowing that we have similar airway opening effects using the same stimulation parameters, supine and non-supine, this is again a great advantage that we offer and that we can contribute completely on the fact that we have a bilateral stimulation.

Got it. And Olivia, 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

um you know it's going to shape up once you all become commercial gentlemen congrats on the progress and thank you for taking my questions well thank you for the question surajan and again to your point we also we start opening the label discussion that is part of our module for submission so that is what we will bring in and based on our data we will really pursue uh the option to have the supine position really explicit in our in our label And I think based on this, and I'm coming back to our mission, and that is making sleep simple again, based on this, for a physician, it becomes obvious, working with Genio, you know that you don't need to worry too much and that you can always maintain the airway of patients open, regardless of their sleep position. And that is really, really a clear benefit.

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

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

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. So it allows us to have a laser-focused launch on top AGNS accounts, which constitutes the vast majority of implants. Next to this, we want to develop relationships 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 AGNES accounts. Well, the scalability patient follow-up strategy, which includes field clinical engineers to monitor implants and patient management specialists to focus on titration and patient follow-up. This increases the sales force capacity as sales reps can focus on lead generation and can also focus on what they are hired for, and that is increasing sales. There will be a limited DTC focus on product differentiation, of course, and on top of this, we also will have a prior authorization team in place at launch. Now, how will we differentiate and how will we break the monopoly and take share from the competition? A, we will focus on our superior efficacy due to the supine AHI reduction. I think I already was pretty clear about this. And B, we will have our product differentiation, no implantable pulse generation, implant for life, fully scalability of our technology, a single incision, no leads, no risk for leak breakage. So those two will be our key factors that we will use within our sales force. The superior efficacy based on supply and HR deduction and product differentiation, making sleep simple again.

That'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, you know, Check if you guys are indeed feeling good about the ability to manufacture and get the ground running in, you know, 25 in the U.S. And I had one follow-up. Thanks.

Correct. So for the U.S. sales specifically, we have contracted with a leading U.S. medical device manufacturer, incidentally also the same as competition is using, that will provide systems for the U.S. market at the first stage. Currently, we are having our Belgian manufacturing site for European commercial supply that will be further extended to also be able to supply for the US. 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 ceramic encapsulation version of Genio, which is easier and less expensive to manufacture.

Good color there, Olivia. 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 the background of that agreement or the genesis of the agreement? And 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 you know, payer coverage in the United States. It sounds like you expect U.S. payers to come on pretty quickly, you know, after approval, but maybe just talk about the confidence there, and thank you for taking the questions.

Yeah, no, no, definitely.

So, we have partnered with the 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 GENIO procedures and is currently covered by all Medicare administrative contractors, or MACs. 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 draft limited coverage articles for GENIO that will leverage those decisions. We have the full influence and support of the AEO for our strategy demonstrated in their decent partnership.

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

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

Thank 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 implants by the end of this year, by the end of 2024. Once we close the study, there will be a 12-month follow-up that will bring us to the end of 2025. Then we will file a PMA supplement, and therefore we anticipate a six to nine-month review period. So we expect to receive a label expansion in mid-26. 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 and dream at non-CCC patients. There, we are really making sleep simple again by physicians not having to worry about in what position people are sleeping. Now, when you look at CCC patients versus non-CCC. Again, this is under the same umbrella in our strategy in making sleep simple again, that over time, also physicians don't need to worry whether a patient is suffering from CCC or non-CCC. Not to forget, this will also eliminate 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 how they sleep and that can mimic, in fact, a natural night's sleep. Great.

Thank you.

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

Oh, great. Thanks for taking the questions here, and congrats on the progress so far this year.

I wanted to start on Germany. I want to make sure I heard a couple things correct, that for the full year, MBU actually had a 27 percent share closer to 50 in the fourth quarter. Wondering if you have a sense for the number of centers that you're in today, and then whether or not, or just any more color on the progress with the partnership you have with ResMed out there that I have a follow-up.

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

Okay, great. I wanted to ask maybe about some of the commercialization, you know, thoughts, high-level thoughts in the U.S. If I heard you correctly, I think you're looking to bring on 25 dedicated U.S. salespeople, and just wondering what you think the addressable or the immediate opportunity for those salespeople could be, meaning, you know, if we're modeling, you know, 200 centers or so coming online with about, you know, one implant per center per month, 10 to 25 sales reps that you initially have in 2025, expand that level or support that level of growth, or do you need to continually add as you get into 25 and 26? Thank you.

No, no, Anand. It's a very valid question. I can tell you it's also a question that keeps us busy internally in defining and see how we can make the most successful launch in going forward. No, as I mentioned, we will start with a laser-focused launch on top eight. Just to provide you some code, we are not going after 200 accounts from the get-go for the simple reason that we want to ensure high implant quality and therefore we need to train the surgeons in a quality way. Of course, also being time conscious, but we have to put the quality always first because we want to have our first patients also showing success that we see in our clinical data. So that's number one. 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 or launch success? I mean, there are a couple of parameters. First is breaking the monopoly that currently is existing when it comes to AG&S in the US and expanding the AG&S market. That is one of our strategies. Next, of course, we want to exceed the street expectations. And third, we want to make sure that we can extend our cash runway to mid-26 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 four to five implant accounts from the gate goal, and that we expect every account to do minimum an implant a week, if not two implants a week. So that we can then you can start modeling it out in your model.

All right, that's very helpful. Thanks so much.

And our last question will come from Michael Polark with Wolf Research. Your line is now open.

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

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

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

Yeah, no, no, and definitely. So first of all, I will not comment too much because out of respect also for Christophe, when he was joining us, he 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 there. And I do think that it was the best solution for both Christophe and Ixoa 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 leader that the US market deserves and that also the US team will deserve to have a successful launch. so the process is ongoing we have several candidates that we met we are now having a short list and together with our board and also with some other members of our team including dr boone we will be shortly announcing our new cco and then also help us prepare the us launch thank you so much ladies and gentlemen

That does conclude the Q&A session and today's conference call. Thank you for participating. You may now disconnect. you Thank you. Thank you. Ladies and gentlemen, thank you for standing by. Welcome to NXO first quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you would 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 11 again. please be advised that today's conference call is being recorded. I would like now to turn the conference over to Michaela Kirkwood, Investor Relations and Communications Manager. Please go ahead.

Good afternoon and good evening, everyone, and welcome to our earnings call for the first quarter of 2024. I am Michaela Kirkwood, Investor Relations and Communications Manager at NXOA. Participating from the company today will be Olivier Tillman, Chief Executive Officer, and Lalique Morel, Chief Financial Officer. During the call, we will discuss our operating activities and review our first quarter of financial results released after U.S. markets 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. These statements involve material risks and uncertainties that could cause actual results or events to material 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 lessened description of the risks and uncertainties associated with their 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.

Thank you, Michaela.

Good afternoon and good evening, everyone, and thank you for joining us for our first quarter 2024 turnings call. 2024 has been transformational for Nixoa. In March, we announced our dream US pivotal study, achieved its primary endpoint, and demonstrated that Genio has the potential for best-in-class outcomes for OSA patients. I would like to congratulate our clinical team on these terrific results. Our regulatory team is working diligently to file the fourth and final module in our Modular PMA Submission Disc Order, which will set the stage for entering the US market upon FDA approval as early as the end of 2024. Additionally, Dr. Moritz Boone, one of the pioneers in hypoglossal nerve stimulation, joined us from Thomas Jefferson University as chief medical officer, and we announced a partnership with the American Association of Otolaryngology at the Neck Surgery Foundation to drive Medicare and commercial payer coverage. Commercially, we reported first quarter sales of 1.2 million euros, almost tripling revenue from the first quarter of 2023 and benefiting from our focused approach on strengthening collaboration between implant surgeons and referring sleep physicians. To recap DREAM, the study had co-primary endpoints of AHI responder rate per the shared criteria at 12 months and ODI responder rate at 12 months. At baseline, subjects had a mean AHI of 28.0 ODI of 27.0 and a body mass index of 28.5. On an intent to treat or ITT basis, DREAM study showed an AHI responder rate of 63.5% with a p-value of 0.002 and an ODI responder rate of 71.3% with a p-value less With these strong results, the DREAM study met its primary endpoints. Additionally, subjects demonstrated a median 12-month AHI reduction of 70.8%, with similar AHI improvements in supine and non-supine sleeping positions. The safety results were favorable. with 11 serious adverse events, or SAEs, in 10 subjects, resulting in an SAE rate of 8.7%. Out of the 11 SAEs, three were device-related, and there were three explants. The DREAM results further differentiate Genio, as it was the first 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, Genio maintains its efficacy. Based on early feedback from the physicians, this can be very impactful on therapy selection. It supports our mission to make sleep simple again, and we intend to apply for the inclusion of supine efficacy results in our label. With the positive DREAM results, we are now finalizing our modeler PMA submission. We have responded to the FDA questions on the first three modules and are in an interactive review and anticipate filing the fourth and final module this quarter. We are preparing for a launch by the end of 2024 as based upon modeler PMA review cycle times. We anticipate FDA approval in late 2024 or early 2025 as we do not control FDA timelines. In parallel, We continue making progress on the reimbursement site as we are establishing reimbursement pathways with commercial payers, Medicare and Medicaid. The reimbursement team is working closely with the AIO and reimbursement experts to secure coverage at FDA approval. Ahead of approval, we will be conducting a payer feedback interview with the former CMS and Commercial Plan Medical Director, as well as participate in the early payer feedback program for the FDA, designed to provide direct feedback from major payers, such as UnitedHealthcare, Blue Cross Blue Shield, Aetna, as well as CMS. Upon commercialization, we will have a prior authorization team in place to assist with claims submission and payment. Our U.S. focus is significantly increasing, highlighted by the recent addition of Dr. Mo Boon as Chief Medical Officer. Dr. Boon, who joins NCSOA from Thomas Jefferson University, is internationally recognized as one of the most experienced surgeons in the field of OSA and AGLS. Being able to have such high caliber talent Joining Nixoa is a strong validation of the opportunity for Genio to disrupt the OSA market. We are actively building our US commercialization team to be ready to launch by the end of this year. The current AGNS market in the US is very concentrated, allowing for a laser-focused launch, breaking the current monopoly with EMT sites, while establishing a patient referral pathway from sleep specialists. As part of FDA approval process, we ran a usability study with 31 physicians that are the top AGNS implanters in the US, and their feedback was overwhelmingly positive. Providing a little more color on the usability study, naive surgeons meaning surgeons without experience with Genio were invited to participate in a training session on how to safely use the device. The training contained theoretical sessions followed by both animal and cadaver implants. Twelve hours later, mimicking a real OR setting, surgeons had to repeat the implant without guidance to demonstrate they properly retained the knowledge on device programming and acquired the implantation technique, always ensuring patient safety and comfort during the procedure. These surgeons were adamant they want to be the first Genio implanters in their areas and convinced of the differentiation of Genio versus current AGNS technology in terms of invasiveness, patient-centricity, safety, and the simplicity to treat OSA patients regardless of their sleeping position. In addition, a recent independent survey demonstrated that over 20% of USAGNS candidates are declining a pacemaker-based platform technology due to their concerns over the invasiveness and having implantable battery in the chest. Going back to Europe, first quarter sales was 1.2 million euros, an increase of 177% of the first quarter of 2023. As part of our commercialization of commercial proof of concept in Germany, we see that first, the majority of accounts became mixed implanting accounts, embracing Genio in their practice. Second, therapy penetration is strongly accelerating as a result of Genio entering the market as a new player. And third, there is a large pool of CPAP quitting patients in need for treatment, which can be addressed through establishing a strong collaboration between implanting surgeons and referral sleep physicians, highlighted by our ResMed collaboration. In summary, We started 2024 strongly by reporting positive dream data, further differentiating Genio with our unique supply index. For the remainder of the year, we are working towards FDA approval by the end of the year and commercial readiness for a strong US launch in 2025. With that, I'm pleased to turn the call over to our CFO, Louis Moreau, who will provide a financial update.

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

Thank you. As a reminder, to ask a question, please press star Excuse me. Please press star 1-1 on your telephone and 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. The first question comes from John Block with Stiefel. Your line is now open.

Thanks. 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 two of that first question would just be, you know, the burden rate that we can expect as you ramp up the commercialization efforts in the coming months, I think, you know, headcount and prepping for launch, as you mentioned, by potentially the end of this year, fourth quarter of, of 2024, and then I'll ask my follow-up. Thanks, guys.

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

Just 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 by the end of this year.

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

Okay. Got that. And if I have any additional questions there, I'll clarify offline. I think just to pivot for the second question, you know, post the release of the DREAM top-line data, we perform checks among 30 physicians and ask them how they view The dream data relative to INSPIRE's STAR, and, you know, I sort of categorize the findings as upbeat. The majority of you dream as equivalent to STAR. There was about 20% saying superior and about 17% saying inferior. So, you know, painting it with a broad brush, largely equivalent. Here we are just almost two 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 NXO have heard from the docs and maybe the reaction in the marketplace to the data, that'd be very helpful.

No, no, definitely, John. And also, thank you for the work that you did on gathering this data. Now, let me first of all remind you that the study I was not designed for a head-to-head comparison. There are a few different characteristics making DREAM more challenging than STORS. To name the most important one is having minimum 60 minutes supine sleep for all our patients in order to qualify as a responder. And there is also the broader AHI range, where in DREAM you have a range between 15 to 65, where in STAR 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 this data. So our AHI and ODI respond rates are in line with our competitors' study starts, calculated on an intent-to-treat basis, and our median AHI reduction is even slightly higher. In general, as physicians are well aware of, it's harder to control OSA when patients are supine compared to non-supine because it's more difficult to maintain an open airway in a supine position, mainly driven by gravity. While we plan to hold the data for publication, I can already comment that Genio showed similar AHI reductions in both supine and non-supine positions. While requiring patients to sleep supine may dream more challenging, the data provides evidence that Genio will be able to control patients' OSA regardless of their sleeping position. And I do think, and this is also the feedback that we are getting when we are talking more in-depth with physicians and also know that we have Dr. Boon on board explaining it even better than I can to other physicians, we see that this is really perceived as a really, really differentiating factor making the choice for a physician because they do not need to worry whether the patient is sleeping supine or non-supine, knowing that in data, 35 to 40% of normal standard night, people are sleeping on their back. So I do think that the supine data aspect is really differentiating Genio from Storr, 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 STORS trial.

Very helpful. Thanks, guys.

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

Good afternoon, Olivier, Eloy. Can you hear me all right?

Yes, we can. Hello.

So, Olivier, congrats on all the progress. piggybacking on your comments about supine, right? Obviously, that piqued everyone's curiosity. And my first question is a multi-part question, if I could. How is the debate on hypoglossal nerve stem efficacy, supine, non-supine, how is it brewing in the field? And also recently, there was an Inspire paper that was talking about decreased efficacy in supine position yes forgive me olivia if you look at you know one of the arguments made is well the titration is done in supine position so this whole debate becomes mood i'd love to have your uh take on this uh when is the titration really done is it supine non-supine If you could shed some color there and also the implications for a label if really the titration is done in a supine position. Sorry, it was a multi-part question. Hopefully, you got the gist of it.

I hope I will be very complete in my answer, but let me start with the first part. So, yes, this supine versus non-supine is also creating a lot of further discussion within the EMT sleep surgeons. community for a simple reason that when surgeons are deciding to choose for a therapy it's really important that they try to keep it as simple as possible and knowing that you have the same osa 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. On top, we also know that when a patient moves and turns into a supine position, that AHI is twice as high when they are supine as when they are non-supine. There are even patients who are not suffering from moderate or severe OSA when they are non-supine and become a severe OSA patient once they turn supine. So again, an illustration of how important it is to have a technology that can guarantee that the airway is opening or stays open during a supine sleep position. Now, at this moment, DREAM is the only study to require patients to sleep minimum 60 minutes supine at a 12-month follow-up visit And this result showed similar AHI reductions compared to STAR. However, for Genio, it did not matter whether patients were sleeping supine or non-supine. STAR did not have a requirement to sleep supine at a 12-month visit and has not presented any data on supine efficacy from the study in the STAR trial. 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 median AHI reduction reported in the recent publication, based on this, I hope you agree with me that I can conclude that Genio has a superior outcome in the supine position. Was I complete in my explanation, or am I missing still something?

No, sorry, it was a multi...

The titration part, Olivier, one of the arguments is, well, the titration for hypoglossal nerve stem is done essentially in supine position. So it should not matter the supine, non-supine. You know, in all honesty, I never thought about at what point is the titration done. And I'd love to get some clarity on how is titration done for Genio?

Yes. Now, let me start by first commenting on the fact that titration is done in a supine position. So this is not the case for Genio. But if we just stay on the topic that titration is done for a supine position, it would also imply that there is an over-titration in a non-supine position. And we all know how sensitive patients can be. for stimulation. The last thing we want to do is wake them up. So I do think it's important that 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 base, studying the PSG exam and pre-programming or activation chip, we can offer a solution where we stimulate precisely for a patient in function of his or her needs to maintain the airway open. To that extent, knowing that we have similar airway opening effects using the same stimulation parameters, supine and non-supine, this is again a great advantage that we offer and that we can contribute completely on the fact that we have a bilateral stimulation.

Got it. And, Olivia, 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 it's gonna shape up once you all become commercial. Gentlemen, congrats on the progress, and thank you for taking my questions.

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

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

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

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. So it allows us to have a laser-focused launch on top AGNS accounts, which constitutes the vast majority of inflows. Next to this, we want to develop relationships 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 AG net icons. Now, the scalability. patient follow-up strategy, which includes field clinical engineers to monitor implants and patient management specialists to focus on titration and patient follow-up. This increases the sales force capacity as sales reps can focus on lead generation and can also focus on what they are hired for, and that is increasing sales. There will be a limited DTC focus on product differentiation, of course, and on top of this, we also will have a prior authorization team in place at launch. Now, how will we differentiate and how will we break the monopoly and take share from the competition? A, we will focus on our superior efficacy due to the supine AHI reduction. I think I already was pretty clear about this. And B, we will have our product differentiation, no implantable pulse generation, implant for life, fully scalability of our technology, a single incision, no leads, no risk for leak breakage. So those two will be our key factors that we will use within our sales force. The superior efficacy based on supine HI deduction and product differentiation, making sleep simple again.

It'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, you know, Check if you guys are indeed feeling good about the ability to manufacture and get the ground running in, you know, 25 in the U.S., and then add one follow-up. Thanks.

Correct. So for the U.S. sales specifically, we have contracted with a leading U.S. medical device manufacturer, incidentally also the same as competition is using, that will provide systems for the U.S. market at the first stage. Currently, we are having our Belgian manufacturing site for European commercial supply that will be further extended to also be able to supply for the US. 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 ceramic encapsulation version of Genio, which is easier and less expensive to manufacture.

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 the background of that agreement or the genesis of the agreement? And 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 you know, payer coverage in the United States. It sounds like you expect U.S. payers to come on pretty quickly, you know, after approval, but maybe just talk about the confidence there and thank you for taking the questions.

Yeah, no, no, definitely.

So, we have partnered with the 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 GENIO procedures and is currently covered by all Medicare administrative contractors, or MACs. 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 draft limited coverage articles for GENIO that will leverage those decisions. We have the full influence and support of the AEO for our strategy demonstrated in that ISM partnership.

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

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

Thank 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 implants by the end of this year, by the end of 2024. Once we close the study, there will be a 12-month follow-up that will bring us to the end of 2025. Then we will file a PMA supplement, and therefore we anticipate a six to nine-month review period. So we expect to receive a label expansion in mid-2026. 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 and dream at non-CCC patients. There, we are really making sleep simple again by physicians not having to worry about in what position people are sleeping. Now, when you look at CCC patients versus non-CCC, again, this is under the same umbrella in our strategy in making sleep simple again, that over time, also physicians don't need to worry whether a patient is suffering from CCC or non-CCC. Not to forget, this will also eliminate 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 how they sleep and that can mimic, in fact, a natural night's sleep.

Great. Thank you.

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

Oh, great. Thanks for taking the questions here, and congrats on the progress so far this year.

I wanted to start on Germany. I want to make sure I heard a couple things correct, that for the full year, MBU actually had a 27 percent share closer to 50 in the fourth quarter. Wondering if you have a sense for the number of centers that you're in today, and then whether or not, or just any more color on the progress with the partnership you have with ResMed out there that I have a follow-up.

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

Okay, great. I wanted to ask maybe about some of the commercialization, you know, thoughts, high-level thoughts in the U.S. If I heard you correctly, I think you're looking to bring on 25 dedicated U.S. salespeople, and just wondering what you think the addressable or the immediate opportunity for those salespeople could be, meaning, you know, if we're modeling, you know, 200 centers or so coming online with about, you know, one implant per center per month, 10 to 25 sales reps that you initially have in 2025, expand that level or support that level of growth, or do you need to continually add as you get into 25 and 26? Thank you.

No, no, Anand. It's a very valid question. I can tell you it's also a question that keeps us busy internally in defining and see how we can make the most successful launch in going forward. Now, as I mentioned, we will start with a laser-focused launch on top eight. Just to provide you some callers, we are not going after 200 accounts from the gate go. For the simple reason that we want to ensure high implant quality and therefore we need to train the surgeons in a quality way. Of course, also being time conscious, but we have to put the quality always first because we want to have our first patients also showing success that we see in our clinical data. So that's number one. 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. First is breaking the monopoly that currently is existing when it comes to AG&S in the US and expanding the AG&S market. That is one of our strategies. Next, of course, we want to exceed the street expectations. And third, we want to make sure that we can extend our cash runway to mid-26 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 four to five implant accounts from the gate goal, and that we expect every account to do minimum an implant a week, if not two implants a week, so that we can then you can start modeling it out in your model.

All right, that's very helpful. Thanks so much.

And our last question will come from Michael Polark with Wolf Research. Your line is now open.

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

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

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

Yeah, definitely. So first of all, I will not comment too much because out of respect also for Christophe, when he was joining us, he 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 Ixoa 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 leader that the US market deserves and that also the US team will deserve to have a successful launch. So the process is ongoing. We have several candidates that we met. We are now having a shortlist and together with our board and also with some other members of our team, including Dr. Boone, we will be shortly announcing our new CCO and then also help us prepare the US launch.

Thank you so much.

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