Nyxoah SA

XBRU:NYXH

Earnings Call Transcript 2024-Q1

[Operator]

Ladies and gentlemen, thank you for standing by. Welcome to Nyxoah First Quarter 2024 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference call is being recorded.

I would like now to turn the conference over to Mikaela Kirkwood, Investor Relations and Communications Manager. Please go ahead.

[Mikaela Kirkwood, executive]

Good afternoon and good evening, everyone, and welcome to our earnings call for the first quarter of 2024. I am Mikaela Kirkwood, Investor Relations and Communications Manager at Nyxoah. Participating from the company today will be Olivier Taelman, Chief Executive Officer; and Loic Moreau, Chief Financial Officer.

During the call, we will discuss our operating activities and review our first quarter 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 materially differ from those anticipated or implied by these forward-looking statements.

All forward-looking statements are based upon current available information, and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 20-F filed with the Securities and Exchange Commission on March 20, 2024.

With that, I will now turn the call over to Olivier.

[Olivier Taelman, executive]

Thank you, Mikaela. Good afternoon, and good evening, everyone, and thank you for joining us for our first quarter 2024 earnings call. 2024 has been transformational for Nyxoah. In March, we announced our DREAM U.S. 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 model of 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.

Additionally, Dr. Maurits Boon, 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 next [indiscernible] foundation to drive Medicare and commercial payer coverage.

Commercially, we reported first quarter sales of EUR 1.2 million, 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 by the [ shaft site ] area at 12 months and ODI respond 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 response rate of 71.3% with a p-value less 0.001. With these strong results, DREAM study met its primary endpoints. Additionally, subjects demonstrated a median 12-month 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%. Of all the 11 SAEs, 3 were device related, and there were 3 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 spin and non-supine. This is of particular importance since published data show increased over [indiscernible] 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 standup 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 model of PMA submission. We have responded to the FDA questions on the first three modules and already in an interactive review and anticipate filing the fourth and final module this quarter. We are preparing for the launch by the end of 2024 as based upon model of PMA review cycle plans. We anticipate FDA approval in late '24 or early '25 as we do not control FDA time lines.

In 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 [ 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 for major peers, such as United Healthcare, 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. Maurits Boon as Chief Medical Officer. Dr. Boon, who joined Nyxoah 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 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 common AGNS market in the U.S. is fairly concentrated, allowing for a laser-focused launch [ relating ] the current monopoly with [ ENT ] 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 implants in the U.S. and their feedback was overwhelmingly positive, providing a little more color on the usability study. Naive surgeons meeting surgeons with all experience with Genio were invited to participate in a training session [ notably ] and safely use the device. The training contains theoretical session, followed by both animal and [ cadaverine plants ]. 12 hours later, mimicking real [ offsetting ] surgeons had to repeat the implant without guidance to demonstrate that properly retain the knowledge on device programming and acquires the implantation technique, always ensuring patient safety and comfort during the procedure. These surgeons work 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 U.S. AGNS candidates are declining [indiscernible] 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 EUR 1.2 million, an increase of 177% of the first quarter of 2023. As part of our commercialization or commercial proof of concept in Germany, we see that, first, the majority of accounts became mixed implanting accounts embracing Genio in their practice. Second, tenet 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 [indiscernible] patients in need for treatment, which can be addressed through establishing a strong collaboration between implanting surgeons and referral sleep physicians, highlighted by our [indiscernible] collaboration.

In summary, we started 2024 strongly by reporting positive DREAM data, further differentiating Genio with our unique supine [ data ]. 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. launch in 2025.

With that, I'm pleased to turn the call over to our CFO, Loic Moreau, who will provide a financial update.

[Loic Moreau, executive]

Thank you, Olivier. Good day to everyone, and thank you for joining us today. Revenue for the first quarter ended March 31, 2024, was EUR 1.2 million, a EUR 177 million increase over the first quarter of 2023. Total operating loss for the first quarter was EUR 12.2 million versus EUR 11.4 million in the first quarter of 2023, driven by an acceleration in commercial investments in the U.S. as well as in Europe. As of March 31, 2024, cash and financial assets totaled EUR 44.3 million compared to EUR 57.7 million on December 31, 2023. During the first quarter, our monthly cash burn was EUR 4.5 million. Based on our current cash position, we had a runway into late 2024 which includes the building of the U.S. 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.

[Operator]

[Operator Instructions] The first question comes from John Block with Stifel.

[Jonathan Block, analyst]

First question, Olivier, just any details on where market share shipped out in 2023 for Genio in Germany and your thoughts on 2024? And then part two 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, I think head count 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.

[Olivier Taelman, executive]

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?

[Jonathan Block, analyst]

How we should view whether you want to do a monthly burn or quarterly burn as you ramp up some of the commercialization efforts to prepare by launch by the end of this year?

[Loic Moreau, executive]

So we burned EUR 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 organization. As we said, we have cash until late 2024, and that includes the build of the U.S. commercial team.

[Jonathan Block, analyst]

I think just to pivot for the second question, post the release of the DREAM top line data, we perform checks among 30 physicians and asked them how they view the DREAM data relative to Inspire STAR. And I sort of categorize the finding is [ upbeat ], the majority of [ DREAM ] is equivalent to STAR. There was about 20% saying superior and about 17% setting inferior. So 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 Nyxoah have heard from the docs and maybe the reaction in the marketplace to the data, that would be very helpful.

[Olivier Taelman, executive]

No, no, definitely, John, and I also thank you for the worry 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 stores, 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 the range was [ 20 to 50 ].

Now that being said, -- of course, we fully understand the nature of the question. I also fully understand why physicians and a lot of people are looking how to compare this data. So our AHI and ODI response rates are in line with our competitors' study stock, calculated it on in [ term-to-tree ] basis, and our median AHI reduction is even slightly higher. In general, as physicians are well aware of, it's hard 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 spine 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 were talking more in [indiscernible] [ physicians ] and also now that we have [ Dr. Budenberg ] explaining it even better than I can to other physicians. We see that this is really perceived as a really, really differentiating factor of making the choice for a 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 the normal standard night, people are sleeping on their back. So I do think that the supine data aspect is really differentiating Genio [ from STAR ] 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 STAR trial.

[Operator]

The next question comes from Suraj Kalia with Oppenheimer.

[Suraj Kalia, analyst]

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 hypoglossal nerve stem efficacy, supine, non-supine, how 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 smooth. I'd love to have your take on this. When is the titration really done? Is it supply? Non-spine? If you could shed some color there. And also the implications for a label if really the titration is done in a supine position.

[Olivier Taelman, executive]

I hope I will be very complete in my own [indiscernible], but let me talk 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 surgeon community for the simple reason that once surgeon start deciding to choose for the 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 turned into a supine position that AHI is twice as high when they are supine versus when they are non-supine. There were even patients who are not suffering from moderate [indiscernible] OSA and become a severe OSA patients once they turn supine. So again, a registration, how important it is to have a technology that can guarantee that the airway is opening or stays open during a supine position.

Now at this moment, DREAM is the only study to require patients to sleep minimum 60-minute 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 sleep in 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 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 still missing something?

[Suraj Kalia, analyst]

No, sorry, it was a multi part. I mean the titration part, Olivier, one of the arguments as well the titration for hypoglossal [ neural stim ] is done essentially in a 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. And I'd love to get some clarity on how is titration done for Genio?

[Olivier Taelman, executive]

Yes. No, 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 superposition, it would also implies 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 tail [indiscernible] based studying the PSG exam and [ 3 ] programming [ organization ] ship, we can offer a solution where we stimulate precisely of 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.

[Suraj Kalia, analyst]

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 are considering presumably as low-hanging fruit and treating the virtues of Genio, I'd love to understand how you are sensing the choice of device it's going to shape up once you'll become commercial.

[Olivier Taelman, executive]

And again, to your point, we also [ started ] 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 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 the clear [ asset ].

[Operator]

Our next question comes from Adam Maeder with Piper Sandler.

[Adam Maeder, analyst]

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 U.S. sales 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? Kind 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 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 have a follow-up.

[Olivier Taelman, executive]

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 [indiscernible], which constitutes a [ large ] majority of implants. Next to this, we want to develop relationship with key sleep samples in [indiscernible] referrals. So limited and efficient sales force sized appropriately for a targeted launch, which we can scale them opportunistically or time. Being very concrete, we plan to launch with a sales team of around 25 people being laser focused on those top AGNS accounts.

Now the scalability patient follow-up strategy, which includes field clinical engineers to monitor implants and patient management specialists to focus on titrations 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 bring the monopoly and take share from the competition. A, we will focus on our superior efficacy due to the supine reduction, I think I already was pretty clear about this. And, b, we will have our public differentiation, no implantable [indiscernible] generation, implant for life, fully scalability of our technology, a single incision, no leads, no risks for lead breakage. So those two will be of key factors that we will use within our sales force. The superior efficacy based on supine AHI reduction and product discontinuation making sleep simple again.

[Adam Maeder, analyst]

And just from a manufacturing standpoint, I don't think we need to spend too much time here, but just wanted to ask check that you guys are indeed feeling good about the ability to manufacture and hit the ground running in '25 in the U.S. and I also have one follow-up.

[Olivier Taelman, executive]

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 Belgium manufacturing site for European commercial supine that will be further extended to also be able to supine for the U.S. and we are keeping our historical manufacturing facilities in [ Telavist ] for clinical trial inventory. Manufacturing lines are highly scalable, particularly as we will launch with ceramic encapsulation version of Genio, which is easier and less expensive to manufacture.

[Adam Maeder, analyst]

And for the follow-up, I wanted to switch over to reimbursement and ask for more color about the strategic partnership with [ AAO, HNFF ]. What more can you tell us about kind of 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 payer coverage in the United States. It sounds like you expect U.S. payers to come on pretty quickly after approval, but maybe just talk about the confidence there.

[Olivier Taelman, executive]

Yes. No, no, definitely. So we are partnered with [ AAO ], which will make a formal recommendation on an interim [ CPT ] code for us to use directly at launch when we have attained FDA approval. At launch Dr. [indiscernible] Medicare claims using the AAO recommended CPT code, which will closely match the Genio procedures and is strongly covered by all Medicare administrative contractors of MAX. Reimbursement will be in line with current AG&S payment rates, and I think that's also important. We will pursue a Genio specific CPT code got over time, but based upon precedent, this will likely take a couple of years.

Now in going forward, we know that all the MAX have local coverage decisions for AGNS and in collaboration with them, we will [ grasp ] limited coverage [ optical ] for Genio that will leverage those decisions. We have the full influence support of the AAO for our strategy demonstrated in their recent partnership.

[Operator]

The next question comes from Ross Osborn with Cantor Fitzgerald.

[Ross Osborn, analyst]

Maybe just one for me. It would be interesting to hear if there's any update on the ACCESS trial? And then how you think education efforts will progress those data there in the U.S. in terms of being able to utilize your offering with CCC patients, which historically has not been done?

[Olivier Taelman, executive]

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 and plan by the end of this year 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 6- to 9-month review period. So we expect to receive a label expansion in mid '26.

I know this was not really the question, but I do think it's important also to strategically cover out when I was talking about supine versus non-supine, we're also looking in 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 only the same umbrella in our strategy in making sleep central again that all time, also physicians don't need to worry whether the patient is suffering from CCC or non-CCC. Not to forget, this will also eliminate the [indiscernible] currently in place to further determine whether the patient is a CCC or a non-CCC patient so all this together is once again part of our mission. We want to make and we want to offer a solution that will make sleep simple. And physicians and patients can realize they have a safe solution that will be affected regardless of their sleep and that can mimic in fact, a natural night sleep.

[Operator]

The next question comes from David Rescott with Baird.

[David Rescott, analyst]

I wanted to start on Germany. I want to make sure I heard a couple of things correct that for the full year in the [indiscernible] 27% 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 would be a partnership you have with [ ResMed ] out there. And then I have a follow-up.

[Olivier Taelman, executive]

So First of all, today, you are correct in understanding the 27% market 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 implanting the Genio technology. So 51, that's where we stand today. When it comes to our [ ResMed ] partnership, our main goal to the partnership is for developing a patient sample approach by developing a complete OSA ecosystem where patients can be guided to which [indiscernible] therapy does suit their needs. We will collaborate on the initiatives and sales and marketing efforts to [indiscernible] both sleep physicians and EMT services. The goal of the partnership or to expand OSA therapy penetration and of course, to increase our market share in Germany.

[David Rescott, analyst]

I wanted to ask maybe about some of the commercialization thoughts. I thought in the U.S., if I heard you correctly, I think you're looking to bring on 25 dedicated U.S. sales people. And just wondering what you think the addressable or the immediate opportunity for those salespeople that could be, meaning if we're modeling 200 centers or so coming online with about 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?

[Olivier Taelman, executive]

[ No, no ]. 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 going forward. No, as I mentioned, we will start with a laser-focused launch on [indiscernible] [ cost ] to provide you some costs, we are not going after 200 accounts from the getgo 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 too [indiscernible], 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 were a couple of parameters. First is breaking the monopoly that currently is existing when it comes to AGNS in the U.S. and expanding the AGNS market. That is one of [indiscernible] strategies. Next, of course, we want to exceed the street expectations. And third, we want to make sure that we can expand 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 4 to 5 implant accounts from the getgo and that we expect every account to do minimum an implant a week, if not two implants a week, so then we can start modeling in [indiscernible] your [ model ].

[Operator]

And our last question will come from Michael Polark with Wolf Research.

[Michael Polark, analyst]

I'm curious, is Dr. Boon on the call?

[Olivier Taelman, executive]

He's not on this call. [indiscernible], but he will be on the next call, Mike. You can be sure and there will also be opportunities when we will host the investor and an Analyst Day that you can talk extensively to him [indiscernible]

[Michael Polark, analyst]

I did have one other personnel question. I noticed [ Christoph Igenman ] 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?

[Olivier Taelman, executive]

Yes. No, no, definitely. So first of all, I will not comment too much because all of respect also for [ Christophe ], when he was joining us we really, really worked off 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 Nyxoah 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 U.S. market deserves and that also the U.S. team results 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. Boon, we will be shortly announcing our new CCO and then also help us prepare the U.S. launch.

[Operator]

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