Half Year 2021 Nyxoah SA Earnings Call

[music].

Ladies and gentlemen, thank you for standing by and welcome to the Nic solid first half 2021 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 this session you will need to press Star then one on your telephone.

If you require any further assistance. Please press star then zero.

I would now like to hand, the conference over to your speaker for today, Vivian Cervantes Investor Relations at Gilmartin Group you may begin.

Thank you to Wanda good morning, and good afternoon, everyone welcome to our earnings call for the first half of 2021 participating from the company today are Olivier <unk>, Chief Executive Officer, and Paul Beyond Florida, Chief Financial Officer. During the call. We will offer commentary on our operating activity and review our full.

First half financial results released after U S markets closed on August 31.

After which we will host a question and answer session.

The press release can be found in the Investor Relations section of our website.

This call is being recorded and will be archived in the Investor Relations section of our website.

Before we begin we'd like to remind you that any statements that relate to.

Expectations or projections 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 prospectus filed with the SEC on July six 2021 in connection with our initial public offering on NASDAQ.

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

Thank you Liam.

Good morning, and good afternoon, everyone.

Thank you for joining us on our first earnings conference call as a publicly traded company on boat must like a needle in Mexico.

To discuss for first half 2021 operating results.

Before I begin with my script I'd like to think of steam up make sure for their dedication and focus execution, resulting in another direct listing during which we raised $105.0 million.

Having completed two IPO loved them 12 months puts the company in a strong financial position to achieve its vision to become a leading neuromodulation company in the field of obstructive sleep apnea.

I also would like to welcome the new exhaust shareholders and thank them for their participating in all the journey.

In the first half of 2021 we continued to execute on our programs building further on key accomplishments made in 2020.

This includes the first area of focus the pivotal U S. IDE trial called the Dream.

For which we can report steady progress.

Maintaining a target to complete enrollment in Q4 2021.

The second key area of focus being the commercial proof of concept in Germany, but I'm pleased to report that mix or.

Is now fully integrated into the German hospital system with Affordable D O G reimbursement scheme.

Holding in a strong therapy adoption in the topical but I will come back to this later.

Further market expansion activities in Europe. He has altered in a formal DRG coding in Switzerland, It's the SEC.

To deal with the easy investment scheme that we have in place in Europe, and we generated our first revenue in Spain and in Belgium.

Next area of focus is the therapy indication expansion for concentric collapse or complete concentric collapse. So called Triple C patients studied in the better sleep trials.

Better sleep topline results showed that with each family safety performance and bond with a statistically significant mean reduction in HIV for boat people see ma'am.

Non compete concerned follicular patients leading to a submission with the European multi side body to X bump off label to include those complete concentric collapse patients.

In the United States, Nick So our plans on pursuing the FDA breakthrough device designation for the <unk> system.

All of this to shorten the approval path to treat people see patients as well.

We will submit the food better sleep study data to the medical journal for publication.

So he's off following further analysis.

Next next choice strengthening its vision through a collaboration with the U S. Vanderbilt University supported by U S and German key opinion leaders.

In order to integrate a new answer Saturday College stimulation technology.

<unk> scientific and technology Department pipeline.

Saturday College is a difficult not as compared to April of another stimulation and it's also located in the neck of the patient.

We also achieved further advancement in the tech transfer to a second manufacturing facility. The one in Belgium by successfully completing the first phase.

So for the highlights let me know move through a more detailed review of our activities.

Following our successful NASDAQ IPO, we strengthened our balance sheet.

One is to continue to strategically deploy our resources to drive market penetration in Europe.

We advanced our clinical programs scale up and built upon a IV product and adjacent technologies with a focused R&D activities.

Now, let me walk you through our priorities and starting with the first one being the U S Dream pivotal study.

Do you have a dream study or pivotal study in the U S aims to first confirm the safety and effectiveness of the GTO system.

To support marketing authorization of the general system in the U S.

The study plans to enroll 130 for moderate to severe OSA patients.

Failed first line C pulse therapy.

With 12 month effectiveness and safety primary endpoint.

We continued to make progress enrolling patients into the trial.

To date, we have identified 25 <unk> for the trial worldwide.

Of which 16 songs or currently active and enrolling patients in the United States Europe or in Australia, one in Germany, and one in Belgium.

Based on the government enrollment rates, we continue to expect enrollment completion in the fourth quarter of 2021, we.

We expect to obtain FDA approval and GTO system to be commercially available by the end of 'twenty 'twenty three.

Let me discuss our commercial activities.

We are committed to developing and then leveraging key center of excellence as we go deep vessels go wide and driving market penetration of our <unk> system.

Both activities central active engagement.

<unk> and market development across patients physicians and hospitals with focus on high volume Emt substance and sleep doctors, who see diagnose and treat patients with OSA.

We also tailor programs to suit local and regional reimbursement needs.

Leading the pursuit of a fast follower strategy in regions, where there is already people Russell nerve stimulation therapy.

Establishing market leadership in new regions, where we intend to develop good coverage.

In the first half of 2021 in Germany, we successfully transfer of existing and new coding into a dedicated diagnosis related group of DRG for hypoglossal nerve stimulation.

This shift.

With us to ramp up our commercial activities with the judgment calls.

Nick So a commercial proof of concept consists of a two step approach.

Hub 12 months after the Doj reimbursement, becoming German market leader in this proper codes the atlantica one sample of excellence.

In 2012 months after the Doj reimbursement, becoming market leader all over Germany for hypoglossal nerve stimulation.

In the first half of 2021.

20, <unk> systems were implanted in these <unk> in Germany.

During the first half of 2021, there was an increased commercial penetration with a six time, increasing the cones in Q2 versus Q1.

Resulting know in 12 active German accounts.

In addition, <unk> invested in building a German commercial organization by having eight full time employees in Germany led by a German company director.

All of these employees work trend and we have operational by the end of June.

The recruitment of two additional sleep experts, who will interact directly with the sleep labs and patients.

And on top of that a dedicated German marketing manager is ongoing.

Simply put we are strategically hiring personnel as we built out both organization and infrastructure to grow our business.

We plan to drive further expansion by entering new markets.

During the second quarter of 2021, we were able to generate revenue in Spain.

It is a complete new markets for hypoglossal nerve stimulation.

In Belgium.

In these two countries.

Several of Cogs were activated.

And last but not least Switzerland.

Reimbursement under the OSA specific DRG code.

Obtained from the federal statistic office was obtained.

We also submitted a new reimbursement dossier for April also noticed stimulation in Belgium.

Further we are preparing market entry in the Nordic countries, Italy and <unk>.

By actively engaging centers of excellence.

Turning to our clinical program for international markets.

Where they can focus is clearly on the better sleep study.

But sleep as a reminder, it's a multicenter prospective open label two group clinical study to evaluate the safety efficacy and performance of the <unk> system for the treatment of OSA in adult patients with <unk>.

And without complete concentric collapse of the soft palate.

This study is the first study of its guidance to include those people see patients. It was conducted in nine medical centers in Australia, and New Zealand.

In June 21, we announced that the bulk sleep trial reached its primary safety and performance six month and bonds.

And 42 implanted patients.

Of these 42 implanted patients 17 work complete concentric collapse patients.

The data showed us.

Statistically significant mean reduction in the AHRI score from baseline to six months post implantation in the full analysis and the full analysis patient population, meaning both triple seats and multiple Sebastian.

The same statistically significant mean reduction and AHRI.

Triple C patient subgroup only and.

This is a statistically significant mean reduction in IHI from baseline in the CCC.

CCC patient subgroup.

To quote.

Our principal investigator Dr. Richard Lewis the most impressive aspect of the result is the response rate of the complete concentric collapse patient subgroup.

In summary, we continue to build a body of clinical data in support of our bilateral hypoglossal nerve stimulation technology.

We publish the full data set of over better sleep study.

Already have productive dialogue and interaction with the European notified body.

In the United States.

<unk> plans on pursuing the FDA breakthrough device designation for the <unk> system, which we hope will have a positive impact on shortening the approval path to also offer a treatment solution for complete concentric collapse patients.

Let me now turn to a discussion of our research and development activities.

In the first half of 2000.22021, I apologize, we made important progress in our R&D programs.

In January 2021, we received a CE mark for the MRI conditional labeling.

Ensuring the patients implanted with the <unk> system can undergo a full body one five Tesla and three Tesla MRI based diagnostic scan within the poof Packer meters.

We note that MRI compatibility eighth in OSA patients qualify of life with over 40 million <unk> performed on OSA patients in 2020 alone.

With 60% of MRI scans performed in the thorax of abdominal area.

40% of MRI scans and treat Tesla.

To date, we are the only company with an MRI compatibility label for Threet Tesla.

And in February 2021, we announced also our exclusive licensing agreement with the Vanderbilt University.

This is allowing us to access to technologies and capabilities to build a pipeline.

We have started development of this new technology in collaboration with U S. Key opinion leaders, but also with the help of some German key opinion leaders.

New treatment options will focus amongst others on stimulating.

Federico listeners.

As previously noted we developed.

Hope you have a debt of corporate junior system with the obstructive sleep apnea patients in mind.

OMD and initiatives maintain that focus.

Building on these accomplishments, we look forward to delivering an additional milestone milestone that.

For the second half of 2021, we expect to begin marketing in Switzerland.

Public companies in Italy.

With an increase in revenue generated in countries, where we are already present with the key focus on Germany.

We also look forward to opening our manufacturing facility in Belgium.

Further the scale of production capacity and finally in the U S. We continue to expect to complete enrollment in the dream IDE trial by the fourth quarter of 2021.

With this let me now turn the call over to Fabio for financial discussion.

Thank you Audrey zoom good day to everyone. Thank you for joining us on our call.

I will provide some highlights from our P&L and our balance sheet for further details. Please refer to our earnings press release issued yesterday and I'll ask you to report.

Revenue was 355000, new rule for the six months ended June 32021, compared to no revenue for the same period of 2020.

The increase in revenue was.

Beautiful to the cause.

Companys Commerce subsidization of Virginia system.

In Germany, and with some contribution from Spain and Belgium.

Due to an administrative delay in one of our German hospital finances apartments 100000 euro of revenue generating during the second quarter will be recognized in the third quarter.

The total cost of goods sold was 150000, new world with gross profit of 240000, UO or gross margins of 67, 6%.

We realized a net loss of 12 medium.

$18.0 million sorry, Europe for the six months ended June 32000 to two one compared to a net loss of $7.0 million new rules for the same period revenue 2020.

General and administrative expenses increased by $6.0 million euros or 1919th.

99% from $6.0 million Euro for the six months ended June 32020 to $12.0 million for the same period of 2021 dual due to an increase in consulting and contractors.

Research and development expenses increased by 173% before capitalization of 0.6 million doable for the six months ended June 32021, and the city Malone for the same period of 2020.

Research and development expenses increased by one.

1 million sorry.

0.7 million two 1 million.

<unk> due to an increase in staff and consulting costs to support our R&D activities.

Clinical expenses increased by 96%.

Before capitalization of $4.0 million new rules for the six months ended June 32021, and one 4 million new rules for the same period of 2000 and strengthen clinical expenses increased by one 8 million from $10.0 million to three.

One 7 million vehicles.

The increase in <unk> expenses was mainly due to an increase in staff and consultants to support the completion of the better sleep trial includes patients continues recruitment for the <unk>.

That trial and the ongoing dream IV trial trial in the United States.

On June 32021 fashion.

Equivalence totaled $81.0 million compared to $95.0 million euros on December 31, 2020.

The decrease in cash and cash equivalents resulted mainly from net cash flows used in operating activities of $12.0 million euros and net cash used in investing activities of $9.0 million viewers.

In July 2021, we completed our initial public offering in the United States.

$3 million 260250 ordinary shares included over allotment at APA.

At a price to the public of 13.

<unk> per share for total gross proceeds of 97.8 million U S dollar before deducting underwriting discounts and commissions and estimated offering expenses expenses.

Pro forma cash assuming the U S. IPO was completed as of June 30, 'twenty Q1 was $154 seven.

7 million euros with that I will turn the call back toward his view.

Thank you Pablo.

We are now concluding the formal part of our presentation.

Operator, I will turn the call over to you to begin our Q&A session. Thank you.

Thank you ladies.

Ladies and gentlemen, as a reminder to ask a question you will need to press Star then one on your telephone.

We ask that you limit yourself to one question and one follow up.

To withdraw your question press the pound key.

Again, Thats star one to ask the question.

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

Yes.

Our first question comes from the line of Adam Meda with Piper Sandler Your line is open.

Hi, Olivier <unk>.

Congrats on all the progress over the past six months to 12 months and thanks for taking the questions here.

I wanted to start with one on <unk>.

U S path forward regulatory path forward.

It sounds like the Dream study is tracking according to plan, which is great. But was wondering if you could give us some incremental details on things like number of patients implanted in consented.

How are those metrics trending and just talk a little bit more broadly about the level of confidence in delivering against that Q4 2021 enrollment completion. The guideposts that you have given us and then I had a follow up.

Thank you Adam Thank you for the question.

There are several questions in this one question. So let me try to answer that is complete as I cannot at this moment. So first of all I just close by saying what would the regulatory path look like in the U S and going forward.

As we already explained in the past there will be two different routes that we can become eligible for one would be the more traditional PMA.

One would be the normal no.

In order to get more clarity from FDA, we will definitely meet preliminary dream study results for loan safety together further indication on FDA.

So what we expect to do on this one is after these each six months endpoint on a six month point already who look after the safety result of Gopro always was designed in the study and then start interacting with FDA to get more clarity so that as maybe an answer to the first part on the regulatory path PMA, while the genome.

Second part of the question.

I understood correctly is where are we on the enrollment and as mentioned already before we are feeling very confident that we will close the enrollment by the end of this year. So by the end of Q4 to give you some more details on the enrollment currently we have 172 patients enrolled into the.

During the study.

Know that we have 16 sites active in the U S.

Total debt, we have Australia, Germany, and Belgium site.

What we also learned is that by.

By working with the professional recruitment agency gallon that business really impacting in a very positive way also the enrollment on patients.

In conclusion regular regulatory bulk will become more and more clear when we have six months safety data coming from the screen patients and when it comes to the enrollment we stick with our previous commitment to ending this by Q4.

When it comes to speeding up and also to manage current challenging situations in the market, mainly driven by COVID-19 not to call. It. The next year, because I think in business rationale Covid has become part of this but we also take some creative actions like working with recruitment agency like structural property etcetera.

Got it that's very helpful.

The color I appreciate that Olivia and maybe just for my follow up.

Wanted to hear a little bit more about the commercial progress youre, making.

In Europe and in Germany.

Particular.

I think you added a nice chunk of accounts in Q2, maybe just talk about how quickly you anticipate those accounts will ramp how do we think about the revenue contribution from these centers going forward and then just would love to hear how physicians are embraer.

Embracing genie or utilizing <unk>.

And their systems instead of outright switching away from the incumbent product is it trialing splitting.

Just any color there would be would be much appreciate it. Thanks again guys.

Yeah. So so first of all I'm very happy that you noticed also the strong uptake in opening new accounts. So today, we have 12 active account in Germany and this is really this is really exceeding our expectations and let me explain why and therefore I would like to come back to a commercial proof of concept that we hold.

Both in Germany.

Maybe still remember we're talking about a two step approach.

One would be to focus on the tier one of the central of excellence of the topical in Germany, roughly six ago.

Two phase III would be following by other typical automotive experience the cone and also becoming the market leader 24 months or by the end of 2022 in Germany. So what we see today is that the top one of the tier one accounts.

We have opened up vehicles that we are actively engaging with them and that these are the ones that are guiding of implants. That's already part of our strategy and also beating our expectations in the first six months.

Top of this we will.

Solicited by multiple what we call tier two workloads, where there is lots and lots of activity ongoing.

They're reaching out strongly to us. So therefore, we already were happy to communicate that we opened seven more of these <unk>. So in total 12 active accounts in Germany. They are all screening for patients and we will expect in the second half to have all 12 of these ago actively in pumping.

That's the first step.

So next to this offering or physicians or responding and what their reaction is also I can say that the reactions are extremely positive first of all for the surgeon. The income time is so important and we all know having.

Skin to skin times.

61 minutes 62 minutes. So we already communicated that we see skin to skin around 60 minutes. Also this is confirmed by the German surgeons, who are actively implanting. The <unk> technology. So that is already one positive plan. The next positive problem that we get this on the result, when the technology.

Activated.

E&P servings of mainly referring to the bilateral stimulation effect that they really see very concentric pools on the upper airway, which they describe linked to biological stimulation and that patients are also extremely happy when technology is activated.

They will be using this in a very compliant way. So that's the second key.

Key observations that we have.

No in going forward and I already touched on this U S patient group of complete concentric collapse patients.

Currently Contra indicated politically will have some amount of stimulation. So also in this patient group physicians over really waiting for us to get this therapy indication expansion to have the warning that we have currently in the ICU lifted so that they can also implant these patients as well so overall very very positive reactions.

And we also know or focusing on having patients talking to each other and sharing also their personal experience.

That's helpful color I appreciate that Olivia Anne and thanks again for taking the questions.

Yeah.

Thank you with pleasure.

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

Thanks, guys. Good morning, good afternoon.

Olivia maybe for you to start can you just help us with maybe the timing of our next update for the pursuit of Triple C. In Europe, when Youll hear from the regulators and then maybe also the next step or timing on when you expect more color regarding the breakthrough designation in the U S for Triple C as well.

Just any color around the timeline for both of those would be very helpful. And then I'll ask a follow up.

Yeah.

Thank you for the question Jonathan So the first one the modified body you could go over the <unk> Malik expansion to include Triple C. Patients. So we have submitted the file to the notified body and know there are two options based on the review criteria. If they would use the latest MD Oct criteria, we would.

The answer before the end of the year.

If they would still use the existing review criteria.

We think we make a good chunk of that that can happen because we have submitted the file and engage the interaction already before the comfortable what's taking place under the new MD Oct criteria, we could already have nexstar equal to already have an answer by the end of October so it will definitely be before the end of this year best case.

It can also be before the end of October.

Okay, great. Thanks for that and then maybe just to pivot and go back to Adam's question on Dream I think I got the number right. I think you said 172 enrolled is there a raw sort of enroll to implant ratio that you can provide us.

Corner, one is at five to one.

Maybe if you are willing to help us out with that or even better just give us the outright number of implants to date for dream either one of those would be would be very beneficial.

Okay.

This is a little bit for you and you mentioned <unk> to almost 500 of them because to be very precise.

<unk> five <unk>.

And that is the enrollment implant place that we're seeing today. So that is one thing. The next thing is at this moment, we have 22 patients that of which stem are already implanted <unk> mall has been awarded and will be implanted in the coming days I'm also very pleased to announce that we will have Dr. Lewis from Australia.

Flying into the U S are rising on September 'twenty and stay there for two weeks.

The key objective and having for U S.

Emt surgeons fully trained and certified to stock up to and their colleagues.

It is something that I would like to address of being creative based on the COVID-19 restrictions and travel that we're seeing so I'm really pleased that we were able to congress and by having or by presence of most experienced implanted and so also we will make sure that we use.

Place to them train and educate although U S physicians, which definitely I will help amortize the implant ACO, but from an enrollment perspective is going strong we see that we are aligning our patients we are blocking award time.

What we're doing already OEM pumps.

Okay perfect. Thanks for the color guys I'll follow up offline.

And maybe I missed one question.

I want to come back to low income because that was also the question on the breakthrough designation timeline not only on the notified body for CCC, but also breakthrough.

This one I would like to be very precise as you know FDA communicated strict timelines. So 30 days. If you time. This has happened they came back with very positive news to us already with one more question, which we answer so no. We expect the final decision to be communicated in the middle.

September so to speak of September if they respect their 30 day timeline, we should be able to give you also the final answer on whether we have obtained the approval. That's great. So a lot of news to come on the Triple C side, I guess, both from U S and Europe.

Over the next couple of months. Thank you following up on that Olivia I appreciate it.

With pleasure.

Thank you.

Our next question comes from line of Law Robo went to graph Peter Your line is open.

Yes. Good afternoon. Thank you very much.

Station one question from my side.

Could you provide some colors on the success rates.

Did you get on approaching that.

Nursing centers of excellence to cause that.

The <unk> system.

Yeah.

Yeah. So.

So just that.

Did I understand the question precisely so you're asking the success rate when approaching for sandbox is this is this is the question.

Yes indeed.

So what we are seeing.

It's because of all faced approach, where we first focus on BOP samples of top experience some flex with hypoglossal nerve stimulation, we already see that there is very strong.

The existing patients that is patented.

As you know most of the patients they were using seep up they need to be refractory to seep up before they become ineligible political automotive stimulation. So this filtering already is done or it's mostly been done before the patients those specialized top implant site. So it doesn't move.

When the physician is approaching and offering the technology of the flipside technology options, meaning mixed sour versus the one competitor that we're having what we are hearing back is that patients really.

Focused on the fact to have a surgery that has minimal invasive as possible I think that is one key successful ACO success factor, what youre hearing back from patients and from physicians.

Minimal invasive surgery.

Next thing that we are hearing is that patients are also really interested in one deal implanted and not have to come back to offer to the hospital with our technology with the external software over the balance of the system, we can even push to software upgrades the movement of patients just connecting.

External components and the physician is also logging into our platform.

The software updates can be pushed too. So that's the second thing that we're hearing and last we are also hearing.

That when patients for example.

Stocking.

Vote recharging their device about having no battery that can be that can deplete.

Also this is a book by success factor, that's really hitting so in summary minimum invasiveness of the subsidiary.

Next software upgrades that can be pushed through with those go into the hospital last having no implantable battery. So that is the need to replace the battery will give the best we will be depleting that they can simply charge it like they charge their phones. Currently those are the three successful acos and that's what we are hearing back.

I can't very clear many thanks.

Thank you.

As a reminder, ladies and gentlemen that star one to ask a question.

Our next question comes from the line of Michael <unk> with Baird. Your line is open.

Hi, good afternoon.

I'm going to ask again on Dream study I, just want to make sure I have the data straight so.

22 patients implanted so far.

<unk> and.

Additional 12 to be implanted in coming days or weeks, so thats 34.

Total.

The $171 seven zero number enrolled what what does that number mean, because that's higher than your targets. So I'm just trying to trying to true up all these numbers.

Okay.

And Mike Let me, let me also share some more clarity because there are some things that I want to further clarify so first of all when you were mentioning on the implant and the patients that are expanding and implant within awarded so the number of implants that we have done is done and the number that is spending an implant with a fixed award date is 12.

So the total GAAP talking about 'twenty.

Okay. So just to clarify this.

We talked about the 172 patients. So what is this so those are all patients that have been screened that failure.

Keep up the failures or refractory to sweep up so they all eligible patients that off.

Moderate to severe OSA, the only thing that still needs to happen is we still need to undergo a dice because as you know in the.

In the Dream study patients suffering from complete concentric collapse needs to be excluded.

Well, let me say 172, the only thing that is missing to make them eligible is the screening of dice and not being complete concentric collapse and Thats also why the ratio is higher than of course, the implant on yet.

Another common to this due to go even a little bit more of a number that I mentioned, the enrollment versus implant rates youll being four five so in effect if we have.

<unk> that are on the road.

For every <unk> patients we have one patient. That's currently is being implanted and Thats why we still need to enroll roughly four almost patients more before the end of the year in order to make sure that we will hit or.

<unk>.

I hope that makes something clarified things.

So the one the $73.0

All of that needs to be done as dice.

The rough data.

As.

A third of patients have triple C. So they get kicked out leave leaving two thirds.

So is that is that what youre seeing in practice so.

We take the 172, we multiply it by a point.

Six seven in that.

That's maybe a number that's closer to the folks that you have enrolled that are going to be able to move to implant.

So at this moment the number in Europe.

Regulation is a little bit lower to be very precise and not going too much into the detail with what we're seeing is that we will need to Africa fleet 600 patients that qualify to be enrolled in order to get 134 implants.

What we do the calculation.

Okay.

Okay.

Yeah, no I appreciate that and I don't like it.

Ah I wanted to make sure we did as much clarification on this call as possible on that.

So thank you maybe if I can ask on better sleep. So I appreciate all the data insights so far.

My question is.

The investigator in that press release commented that the most impressive.

Data.

Better sleep was the responder rate for the Triple C patients you.

You have not.

And correct me if I'm wrong, you have not disclosed what that responder rate is so can you give us a flavor for what that is or what you see.

And the data.

Unfortunately, I cannot at this moment because as you noted is always this trade off of making between a publication into her into a top medical journal, which you are still aiming for so it would be wrong. If I would if I would comment on things like this because they are not public and when it comes to the statement of Volvo Bi as you can understand.

Extremely happy that we made those statements and those statements are also driven by his own experience revenue.

Participating in the study and what you see with discrepancy, but I cannot comment more than this at this moment, okay and what are the updated timing for a potential publication or more more data disclosure on on better sleep.

They are also on this one Mike. Unfortunately, so what we are currently doing is we are exploring the tradeoff to be made between submitting for publication in a top medical journals vessels disclosing study data in the most fast way I know that everyone, including ourselves and we are really really waiting to see.

See the data to show the data when it comes to Nicaragua. Currently the database is still being analyzed in the medical journal submission is being prepared Unfortunately, we do not control whether it will be accepted.

In which timeframe but.

But as you can understand and I keep coming back we will have to take a strategic decision.

To make the trade off between the top medical journals vessels disclosing as fast as possible, but we also are very well aware that the market and also physicians were waiting to see the analysis and we will do it was best.

To provide you with the full data set.

As soon as we can yes perfect.

If I can sneak one more in.

On the Vanderbilt collaboration the the new target the answer is sort of a call us.

Look I understand this is really early stage work, but at a high level, what what what are believed to be the potential.

Benefits of stimulating that target for OSA versus hypoglossal.

Hmm.

Excellent question.

The.

The reaction and the feedback that we get from the researchers at Vanderbilt, but also supported by top Kols in the U S and in Germany. As I mentioned is the fact that to date April were also modest stimulation is really offering a strong solution for moderate to severe OSA patients.

But there is still a percentage of non responders.

So the question will be whether we will also be conducting further researches okay answer regardless provide them answer those non responders that's already one thing.

Second thing that we're looking at as well as overall facility count is due as a standalone product and hold onto <unk> in combination with people, who also neuro stimulation. So all these pumps will be an examination, but it's clear that with what we can do today. If it were also noticed them. We are focused on the one button.

Mentioned, the anterior posterior dimension of the upper airway.

We also set regardless, we will add a third dimension and by having those those three dimensions, we really believe and we are really proud to be can explore this and worked with the resorts together because that is providing us a pipeline and we are convinced that that also will offer the neuromodulation solution for patient with that.

Currently ethanol solution. So we want to further experiments IPO market cap over the tax would be access to patients.

Currently cannot benefit from Hippobosca notwithstanding.

Yeah.

Thank you I'm showing no further questions in the queue I would now like to turn the call back over to Olivier for closing remarks.

Yeah.

Well thank you.

Thank you.

In closing I would like to close the call by reaffirming the large market opportunity for April automotive stimulation, we really look forward to well addressing the unmet need of this market with our patient centric Gmail solution. So thank you for the questions. Thank you for calling in and listening.

Happy to continue interacting with all of you. Thank you.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.

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