Q1 2024 Nyxoah SA Earnings Call
Ladies and gentlemen, thank you for standing by and welcome to <unk> first quarter 'twenty 'twenty four 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 one one on your telephone.
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I'd like now to turn the conference over to Mackellar Kirkwood, and that's 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.
And the Killer Creek, what Investor Relations Communications manager at next seller participating from the company today, it'll be Olivier Tillman Chief Executive Officer, Mike Brown, Chief Financial Officer.
Mikaela Kirkwood: During the call we will discuss our operating activities and review our first quarter financial results released after market close 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.
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.
Or lessen the 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 'twenty into 2024.
Is that I will now turn the call over to Olivier.
Olivier Taelman: Thank you Mikael.
Good afternoon, and good evening, everyone and thank you for joining us first.
First quarter of 2010 before closing schools.
2012, the score has been transformational for <unk>.
In March we announced the <unk> U S. Pivotal study achieved its primary endpoint and demonstrated that <unk> 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 filed the fourth and final module.
PMA submission this quarter.
Which will set the stage for entry in the U S market upon FDA approval as early as the end of 2024.
Additionally, Dr mortgage.
One of the pilots an EBIT loss of motor stimulation joins us from Thomas Jefferson University.
<unk> Medical officer, and we announced a partnership with the American Association of Otolaryngology head and neck surgery Foundation to drive Medicare and commercial payer coverage.
Dr. Mortgage: Commercially we reported first quarter sales of $1 2 million euros.
Speaker Change: Tripling revenue from the first quarter of 2023 and benefiting from a more focused approach on strengthening collaboration between intense diligence LNG floating sleep physicians.
unknown: To recap Dream. The study has co primary endpoints of HIV spend rate that of the shifts criteria at 12 months and ODI responder rate at 12 months.
At baseline subject at AHRI 28, zero ODI 77 zero in our books at a body mass index of $28 five.
On an intent to treat or ITT basis.
<unk> study showed an HIV sponsor it.
63, 5% with a P value of 0.00.
And the ODI responder rate of 71, 3% with a P value less.
Zero zero.
Speaker Change: With these strong results the dream study met its primary endpoints.
Speaker Change: Additionally, subject demonstrated a median 12 month HIV deduction of 78, 2%.
With similar Hei improvement.
Superman and most supine sleeping positions.
Speaker Change: The safety results were favorable.
Speaker Change: With 11 serious adverse events or <unk>.
Speaker Change: In terms of objects.
Speaker Change: <unk> EBIT of eight 7%.
Speaker Change: Although the 11th says three was device related.
Speaker Change: And there were three excellence.
Speaker Change: The dream results further differentiate <unk> as it was the first <unk> study two requires patients to sleep at least 60 minutes in the supine position and demonstrated strong efficacy with patients sleeping supine amongst you Budd.
Budd: This is of particular importance since published data show increased OSA severity in the supine position.
IHI: With IHI doubling in the Superman vs. The lateral position.
IHI: On average people sleep, 35% to 40% in a supine position you establish slide.
Speaker Change: Which was in line with our PSG findings in the region.
Speaker Change: This means that irrespective of the patients sleeping position <unk> maintains its.
Speaker Change: <unk>.
Speaker Change: Based on early feedback from the physicians this can be very impactful on therapy selection.
physicians: It supports our mission to make sleep simple again, and we intend to apply for the inclusion of supine the efficacy results at all level.
Speaker Change: With the positive drilling results were low finalizing about mobile a PMA submission.
FDA: We have responded to the FDA questions on the first three modules and logging and interactive issue and anticipates filing the fourth and final module this quarter.
Speaker Change: We are preparing for a launch by the end of 12 to 24 is based on a model of PMA review cycle times.
Speaker Change: Anticipate FDA approval in late 'twenty early.
Speaker Change: Early 'twenty five as we do look until FDA timeline.
Speaker Change: In parallel we continue making progress on the reimbursement side the ASP.
Speaker Change: We are establishing reimbursement pathways with commercial payers Medicare and Medicaid.
investment team: The investment team is working closely with the aio and reimbursement experts to secure coverage at FDA approval.
Speaker Change: Ahead of approval, we will be conducting a payer feedback in Brazil with the form of CMS and commercial plan medical director as.
Speaker Change: As well as participate in the early payer feedback program for the FDA.
Speaker Change: Designed to provide direct feedback for major space, such as United Healthcare Blue Cross Blue Shield, Aetna as well as CMS.
Speaker Change: Upon commercialization, we will have <unk>.
Utilization team: Utilization team in place to assist with claims submission and payments.
Dr. <unk>: While the U S focus is significantly increasing highlighted by the recent addition of Dr. <unk> as Chief Medical Officer.
Dr. <unk>: Dr <unk>, who joins <unk> from Thomas Jefferson University.
Dr. <unk>: Nationally recognized as one of the most experienced surgeons in the field of OSA and Ags.
Dr. <unk>: Being able to have such high caliber talent joining the sola is a strong validation of the opportunity for <unk> to disrupt the OSA market.
Speaker Change: We are actively building our U S commercialization team to be ready to launch by the end of this year.
Speaker Change: The government <unk> market in the U S is very concentrated.
Speaker Change: Knowing for a laser focused launch.
Speaker Change: The total monopoly with LTE sites, while establishing a efficiency for both wake from sleep specialists.
Speaker Change: As for the FDA approval process without a usability study with Turkey once physicians.
Speaker Change: That all of the top Ags implanted in the U S.
Speaker Change: And their feedback was overwhelmingly positive.
Speaker Change: Providing a little more color on the usability study.
Nice surgeons: Nice surgeons meeting surgeons without experience with <unk> were invited to participate in a training session.
Nice surgeons: Importantly, and safely use the device.
Speaker Change: The trailing contained theoretical session.
Nice surgeons: Close by both animal and collaborative gloves.
Nice surgeons: 12 hours later mimicking a real offsetting services had to repeat the implant with old guidance to demonstrate that appropriately ethane the knowledge on device programming and acquired the implantation technique.
Speaker Change: Always ensuring patient safety and contract during the procedure.
Virginia: These surgeons work adamant they want to be the first Virginia implanted in their areas and convinced of the differentiation of <unk> versus current AGM, that's technology in terms of Invasiveness.
Speaker Change: Simplicity safety and the simplicity to treat OSA patients regardless of their sleeping position.
Speaker Change: In addition, the rest.
Speaker Change: Independent survey demonstrated that over 20% of U S. Aegean S candidates or declining base makes it based platform technology due to their concerns over the invasiveness and having intangible battery in the chest.
Speaker Change: Going back to Europe.
Speaker Change: First quarter sales was $1 2 million euros.
Speaker Change: An increase of 177% of the first quarter of 2023.
unknown: As part of our commercialization of commercial proof of concept in Germany, we see that first.
Germany: The majority of accounts became mixed implanting the cones embracing <unk> in their practice.
Germany: Second <unk>.
Speaker Change: <unk> penetration is totally accelerating as a result of <unk> entering the market as the new players.
Speaker Change: And third.
Speaker Change: There is a large pool of seep up with these patients in need of treatment.
Speaker Change: Which can be addressed through establishing a strong collaboration between implanting surgeons and the esports sleep physician.
Speaker Change: Highlighted by over estimate collaborations.
Speaker Change: In summary.
2024: We start with the 2024 strongly by reporting positive dream data.
Speaker Change: Further differentiating <unk> with our unique supine them.
Speaker Change: For the remainder of the year.
FDA: We are working towards FDA approval by the end of the year and commercial readiness for its total U S launch in 2025.
Luis <unk>: With that I'm pleased to turn the call over to CFO, Luis <unk>, who will provide a financial update.
Luis <unk>: Thank you Olivia.
Speaker Change: Good day to everyone.
Speaker Change: Thank you for joining us today.
Luis <unk>: Revenue for the first quarter ended March 31, 2024 was $1 2 million euros.
Luis <unk>: 177 increase over the first quarter of 2023.
Speaker Change: Total operating loss for the first quarter was $12 2 million euros.
Speaker Change: $11 4 million in the first quarter of 2023.
unknown: Driven by an acceleration in commercial investments in the U S as well as in Europe.
Speaker Change: As of March 31, 2020 for cash and financial assets totaled $44 3 million euros compared to $57 7 million on December 31 2023.
Speaker Change: During the first quarter, our monthly cash burn was $4 5 million.
Speaker Change: Based on our current cash position, we have a runway into late 2024, which includes the building of the U S commercial team.
Speaker Change: This concludes concludes the formal part of our presentation.
Speaker Change: Okay, great. So I will turn the call over to you to begin our Q&A session.
Speaker Change: Thank you as a reminder to ask a question. Please press star.
Speaker Change: Excuse me. Please press star one one on your telephone and wait for your name to be announced.
Speaker Change: Your question. Please press star one again, please standby, while we compile the Q&A roster.
Speaker Change: The first question comes from Jon Block with Stifel. Your line is now open.
Jonathan David Block: Thanks. Good afternoon first question Olivier just any details on where market share shook out in 'twenty two 'twenty three for Julio.
Jon Block: There are many.
Jon Block: And your thoughts.
Olivier: 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 managed by potentially the beginning of this year fourth quarter of <unk>.
Olivier: 2024, and then I'll ask my follow up thanks, guys.
John: Thank you so John first of all thank you for the question looking back at 2023, and the annual market share and we ended up with 27% overall market share and we had a very strong Q4 closed in 2023, bringing the market share close to 50%.
Speaker Change: That's what I think the first part of your question the second booked work.
John: Just how we should view the I'm, sorry, I, we should be or whether you want your monthly burn on a quarterly burn.
John: As you ramp up some of the commercialization efforts to prepare by launch by the end of this year.
Speaker Change: So we are we've.
Speaker Change: We have been $4 5 million in Q1.
Speaker Change: We expect the burn rate to remain steady for the first half of the year and then begin to ramp up during the second half as we accelerated investments in the U S commercial organization.
Speaker Change: We as we said we have cash until late 2024 and that includes the.
Speaker Change: Build of the U S commercial team.
Speaker Change: Okay got that and if I have any additional questions or I'll clarify offline I think just a pivot for the second question you know post the release of the Dream topline data.
30 physicians: <unk> checks among 30 physicians and ask them, how they view the dream data relative to inspire a star and I would sort of categorize our findings as upbeat. The majority of your dream is equivalent to star there was about 20% in saying superior and about 17% in setting inferior.
Speaker Change: Painting with a broad brush.
Speaker Change: Largely equivalent here, we are just almost two months removed from the topline data being released Olivier and I am curious if maybe you can talk about what you've heard or others that <unk> heard.
Olivier: From the Dax and maybe the reaction in the marketplace to the data that'd be very helpful.
Dax: Diluted genre and also thank you for the work that you did.
Dax: And these data.
Olivier: Let me first of all that in mind you the study design for.
Olivier: How to apt comparison, there are a few different characteristics, making dream more challenging than stores.
Speaker Change: To name the most important one is having minimum 60 minutes supine sleep all of patients in order to qualify as a response.
Speaker Change: There is also the broader HIV age where you have ranged between 50 to 65 led installed in the range of 2250, <unk> being said of course I fully understand the nature of the question I also fully understand why physicians and all those people.
Speaker Change: Looking out to compare these data, so AHRI and ODI disposal rates or in line with our competitors study stock.
Speaker Change: <unk> for the night is.
Speaker Change: Intent to treat basis and will medium HIV reduction is even slightly higher.
Speaker Change: In general.
Junior: Physicians are well aware of it is harder to control OSA when patients or coupon compared to non coupon 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 common debt junior showed similar HIV reduction in <unk>.
Speaker Change: Supine amongst your pipe positions.
Speaker Change: Requiring patients to sleep supine made to be more challenging the data provide evidence that the <unk> will be able to control patients OSA, regardless of the FCB position and I do think and this is also the feedback that we're getting when we were talking more in depth with physicians and also know that we have booked a boom box explaining.
physicians: It's even better than I can do all the physicians, we see that this is really perceived as it really really differentiating factor, making the choice for physician simply because they do not need to worry whether a patient is sleeping supine of non supine, knowing that in data, 35% to 40% open mobile standards.
unknown: People are sleeping on the back so I do think that the supine data aspect is really differentiating <unk> from stock and it's also different shading and showing a strong efficacy and the specifics supine position, which we like to say and claim that this is showing a superiority compared.
Speaker Change: Two what was demonstrated in the stockpile.
unknown: Very helpful.
unknown: Thanks, guys.
Speaker Change: One moment for the next question.
unknown: The next question comes from Suraj Kalia with Oppenheimer. Your line is open.
Suraj Kalia: Good afternoon Olivier can you hear me alright, yes.
Olivier: Yes Hello.
Suraj Kalia: So congrats on all the progress Olivia just piggybacking on your comments about supine right.
Suraj Kalia: See that peaked everyones curiosity and my first question is a multi part question if I could.
Suraj Kalia: How is the debate.
Suraj Kalia: On hypoglossal nerve.
Olivia Right: Efficacy supine non supine, how is it growing in the field.
Olivia Right: Yeah.
Speaker Change: And also recently there was an inspire paper that was talking about decreased.
Speaker Change: You can see in supine position.
Suraj Kalia: Yes.
Suraj Kalia: Great.
Olivia Right: Olivia forgive me.
Olivia Right: If you look at one of the.
Speaker Change: <unk> made as well as the titration is done.
Olivia Right: Supine position. So this whole debate becomes mode.
Speaker Change: To have your it.
Speaker Change: Take on this.
Speaker Change: When does the titration really don't know is it supine non supine.
Speaker Change: Shed some color there and also the implications for enable.
Speaker Change: Really the titration is dominant supine position sorry, it was a multipart question, obviously, you've got that Joseph.
Speaker Change: I hope it will be very complete in my own <unk>, but let me start with the first box. So yes. This is <unk> <unk> is also creating a lot of further discussion within the E&P sleep surgeon community.
Speaker Change: For the simple reason that when surgeons are deciding to choose for the therapy, it's really important that they try to keep it as simple as possible and knowing that you ask the same we'll see.
Speaker Change: We're opening in <unk>.
Speaker Change: Supply in the multi client position is definitely an advantage so that being said if we look at published data showing that 35% to 40% of the time people sleeping in a supine position you understand why this is becoming extremely important.
Speaker Change: We also know that when a patient moved tons into a supine position that AHRI is twice as high when they occupied.
Speaker Change: Coupons, they will even patients who are not suffering from <unk>.
Speaker Change #100: <unk> OSA when there are multiple and become a CV of OSA patients won't they told supine. So again illustration how important it is to have a technology that can guarantee that yodlee is opening of stays open Julian supine position.
Speaker Change: No at this moment Dream is the only study two requires patients to sleep minimum 60 minutes supine as a 12 month follow up visits and this result showed similar HIV deductions compared.
Speaker Change #102: Two stock however for general it did not matter, whether patients who are seeking coupon of multi part.
Speaker Change #103: Staff did not have a requirement to sleep supine at the 12 month visits.
Speaker Change #101: Presented any data on supply and the efficacy from the study in the stockpile.
Inspire Occupy: Leads me to your next question recently, there was a publication done by inspire occupy and data.
Inspire Occupy: We have disclosed and dream that old medium HIV deduction in supine amongst supine CP positions with similar implying around 70% and coupon.
Inspire Occupy: If you compare the 70% that we showed to the 51%.
Inspire Occupy: Supine medium size reduction Polston reported inflation publication based on this I hope you'll agree with me that I can conclude that general as a superior outcome in a supine position.
Inspire Occupy: Well that completes my explanation or am I missing still something.
Speaker Change #101: No sorry, it was a multiple I mean.
Olivier: The titration part Olivier.
Olivier: One of the arguments as well.
Olivier: Titration for hypoglossal nerve.
Olivier: Is done essentially supine position switch.
Speaker Change #105: Should not matter the supine non supine.
Olivier: In all honesty I never thought about what point does the titration dawn.
Speaker Change #108: And I'd love to get some clarity on.
Speaker Change #106: How is titration done for genial.
Speaker Change #107: Yes, So let me start by first commenting on the fact that <unk> has done in a supine position. So this is not the case for <unk>, but if we just stay on the topic that titration is doubtful supine position. It would also implies that.
Speaker Change #106: <unk>.
Speaker Change #109: The oversight patients in a non supine position and real more 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 patients will get the adequate stimulation and therefore again without bilateral stimulation that weekend.
Speaker Change #110: And the way we do this on a tailor made based studying the <unk> zone and the programming or activation chip. We can offer a solution where do we stimulate precisely over patients in function of his or her needs to maintain we're open.
Speaker Change #111: To that extent, knowing that we have similar headway opening effects.
Speaker Change #113: Using the same stimulation partner meters supine non coupon.
unknown: A great advantage that we offer and that we can contribute completely on the fact that we have a pilot biological stimulation.
Olivia Right: Got it and Olivia for my follow up question, if I could I presume the label discussions start in Q3.
Olivia: I am guessing and also the 31 physicians high volume inspire docs that you are considering presumably as low hanging fruit.
Olivia: Im preaching the virtues of genial I'd love to understand how you are sensing.
Olivia: <unk> device.
Olivia: It's going to shape up once you all become commercial gentlemen, congrats on the progress and thank you for taking my questions.
Olivia Right: Well. Thank you for the question Suraj.
Suraj Kalia: And again to your point, we also stopped opening the label discussion that is affordable module folks submission. So that is what we will be in and based on those data we will really pursue.
Speaker Change #115: The option to have the supine position really explicit.
Speaker Change #114: And I think based on this and I'm coming back to our mission and that is making sleep simple again based on this fourth physician becomes obvious working with <unk>. You know that you don't need to worry too much and that you can always maintained yet layoffs patients open. He go up a little bit sleep physician and that is really really.
Suraj Kalia: A clear path.
Speaker Change #128: One moment for the next question.
Adam Carl Maeder: Our next question comes from Adam meter with Piper Sandler Your line is open.
Adam Carl Maeder: Hi, Good evening guys. Thank you for taking my questions and congrats on the progress.
Adam Carl Maeder: I wanted to.
Adam Carl Maeder: Start by asking about some of the preparations that you are making from a sales force and manufacturing standpoint, if I heard some of the remarks correctly it sounds like that.
Adam Carl Maeder: The onboarding of sales from U S sales folks is more back half loaded.
Suraj Kalia: But I was hoping you could get.
Speaker Change #118: A little bit more granular there so.
Speaker Change #119: How many U S sales reps that you hired at the moment.
Suraj Kalia: Kind of how should we think about that building in the back half of the year, where do you expect to be at launch.
Speaker Change #126: 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.
Speaker Change #126: Well. Thank you Evan for the question. So when we look at the revenue.
Suraj Kalia: Look at the loads LNG.
Speaker Change #131: As I mentioned earlier in the call, it's clear that probably Ags in the U S is a very concentrated business. So it allows us to have a laser focus launch HMS.
Evan: <unk>, which constitute the vast majority.
Evan: Yeah.
Speaker Change #117: Next to this we want to develop relationship with key sleep samples to drive referrals.
Speaker Change #120: So limited and efficient salesforce sized appropriately for a targeted launch, which we can scale them opportunistically overtime.
Speaker Change #131: Being very concrete we plan to launch with our sales team overwhelming 75 people being laser focused on those top AG electricals motor scalability.
Speaker Change #125: Just one follow up strategy, which includes field clinical engineers to monitor inflow and patient management specialists to focus on presentations and patient follow up.
Speaker Change #129: This increases the sales folks capacity, our sales reps can focus on lead generation and can also focus on <unk> and that is increasing sales.
Speaker Change #124: There will be a limited BTC focus on product differentiation of course.
Speaker Change #121: On top of this we also will have a prior authorization team in place at launch.
Speaker Change #133: Oh, we'll be distances, and who will be break that monopoly and take share from the competition.
Speaker Change #127: We will focus on our superior efficacy.
Speaker Change #127: Due to the <unk> reduction I think I already was pretty clear about this.
Speaker Change #127: And B, we will have October dislocation no implantable both generation impactful glass.
Speaker Change #123: The scalability of our technology.
Speaker Change #123: <unk> decision moly bogus fully breakage. So those two will be a key factor in that.
Speaker Change #123: I'll use within the sales force the superior efficacy based on supplier HIV deduction and product differentiation, making sleep simpler yet.
Speaker Change #123: 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.
Speaker Change #130: Check you guys R&D and feeling good about the ability to manufacture and hit the ground running.
Speaker Change #136: And 25 and the.
Speaker Change #134: I might add one follow up thanks.
Olivier: So for the U S sales, specifically, we have contracted with a leading U S medical device manufacturer.
Olivier: And so essentially also the same as.
Speaker Change #134: <unk> will provide system sold U S market.
Speaker Change #134: First stage.
Speaker Change #137: Currently we don't have enough of a Belgian manufacturing sites for European commercial supply that will be further extended to also be able to supply for the U S.
Speaker Change #143: Well, keeping or historical manufacturing facilities in penalties for clinical pilot facility.
Speaker Change #137: The manufacturing lines or highly scalable, particularly as we launch we'll see how mccain destination version of <unk>, which is easier and less expensive to manufacture.
Speaker Change #137: Yes, good color there Olivia thank you for that and for the follow up I wanted to switch over to reimbursement.
Speaker Change #142: For more color about the strategic partnership with <unk>.
Speaker Change #140: In SaaS.
Speaker Change #141: What more can you tell us about kind of the background of that agreement or the Genesis of the agreement.
Speaker Change #141: And then I'll also ask any update in terms of how we're thinking about coding vehicle for <unk> in the U S and just pace of.
Speaker Change #152: Payer coverage in the United States. It sounds like you expect U S payers to come on pretty quickly.
Speaker Change #141: After approval, but maybe just talk about the confidence there.
Speaker Change #138: And thank you for taking the questions.
Speaker Change #139: No that's it.
Speaker Change #139: Currently.
Speaker Change #145: So we have partnered with <unk>, which will make a formal recommendation on an interim CPT codes for us but for us to use at launch directed loans when we ask them.
FDA: FDA approval as loans DOCSIS look submit Medicare claims using the <unk> recommended CPT codes.
Speaker Change #144: Which will closely matched the GTO procedures and is currently covered by all Medicare administrative contractors of Max.
Speaker Change #144: Reimbursements will be in line with current Ags payment rates and I think Thats also in Boston, we will pursue a geo specific CPT code overtime, but based upon precedent this will likely take a couple of years.
Speaker Change #144: No.
Speaker Change #144: Going forward we.
Speaker Change #144: Know that all the mix has local coverage decision for <unk> and in collaboration with them, We will golf limited coverage obstacle for general that's the leverage those decisions.
Speaker Change #147: We have the full support of the overall strategy demonstrated in there is that decent partnership.
Speaker Change #148: One moment for the next question.
Speaker Change #149: The next question comes from Ross <unk> with Cantor Fitzgerald. Your line is open.
Speaker Change #146: Hey, guys. Thanks for taking my questions. Maybe just one for me would be curious to hear if there's any update on the access trial and then.
Speaker Change #151: Do you think agitation FX swap progress.
Ross Everett Osborn: As stated are in U S in terms of being able to utilize your offering with triple C patients, which historically has not been done. Thank you.
Ross Everett Osborn: Thank you Ralph and thank you for the question. So we continue to make progress with the access study, but as I mentioned before we will not be disclosing the number of patients implanted that said, we still plan to close implant by the end of this year, but 2024.
Speaker Change #150: Once we close the study.
Speaker Change #150: There will be a 12 month follow up that will bring us to the almost 2025 US then we will file.
Speaker Change #150: You may supplement and therefore, we anticipate a six to nine months periods. So we expect to receive a label expansion in mid 2006.
Speaker Change #154: I know this was not really the question, but I do think it's important also to strategically carbo, both when I was talking about supine versus months, Japan. We are also looking into remap non CCC patients. This will really making sleep simple again by physicians, both having to worry about and what position people are sleeping Norway.
Speaker Change #154: You look at CCC patients versus non CCC again this is under the same umbrella.
Speaker Change #154: LNG and making sleep simple again, that's all the time also physicians don't need to worry whether the patient is suffering from CCC our loan CCC not to forget this will also eliminate the.
Speaker Change #154: Currently in place to further determine whether the patient is seen.
Speaker Change #154: <unk> opened loan CCC patients. So all this together of course is once again part of our mission, we want to make and we want to offer a solution that will make sleep simple with physicians and patients can be utilized.
Speaker Change #154: <unk> solution that will be effective governance or the sleep that can mimic in fact, a natural might seek.
Speaker Change #158: Great. Thank you.
Speaker Change #159: One moment for the next question.
Speaker Change #156: The next question comes from David Reis, Scott with Baird. Your line is now open.
Speaker Change #160: Oh, great thanks for taking that.
David Kenneth Rescott: Questions here and congrats on the progress so far this year I wanted to start on.
David Kenneth Rescott: Germany, I want to make sure I heard a couple of things correct.
Speaker Change #155: On a full year number youre actually that 27% share.
Speaker Change #155: 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.
Speaker Change #172: Progress with our partnership you have with Verizon that are out there that I have a follow up.
Speaker Change #170: Yes, no no.
Speaker Change #155: Currently.
Speaker Change #155: First of all to date you have.
Speaker Change #155: Curriculum, extending the 27% market share for the total year of 2023.
Speaker Change #161: Today, we can say that we have 51 samples that are fully trained and ready to implant.
Speaker Change #161: Or implanting the genial technology, So 51, that's where we stand today.
Speaker Change #161: When it comes to our estimate of partnership or main go through the partnership.
Speaker Change #161: So developing a patient centric approach by developing a complete OSA ecosystem.
Speaker Change #161: <unk> can be guided to reach out for OSA therapy back to that.
Speaker Change #161: We are collaborating on DTC initiatives and sales and marketing efforts to target both sleep physician MGMT services.
Speaker Change #155: The goal of the partnership <unk> pump OSA therapy penetration and of course to increase our market share.
Speaker Change #163: Okay, Great I wanted to ask maybe about some of the commercialization.
Speaker Change #162: Thoughts high level thoughts in the U S. If I heard you correctly I think you are looking to bring on 25 dedicated U S salespeople and just wondering what you think the.
Speaker Change #166: The addressable or the immediate opportunity for those salespeople that could be meaning if we're modeling.
Speaker Change #166: 200 centers or so would be coming online with about one implant per center per month 10 to 12.
Speaker Change #165: <unk> five sales reps that you initially had in 2025.
Speaker Change #162: Span that level or support that level of growth or do you need to continually add as you get into 'twenty five 'twenty six thank you.
Speaker Change #162: <unk>.
Speaker Change #164: It's a very valid question and I can tell you. It's also a question that keeps us busy and thoroughly.
Speaker Change #167: Defining and see how we can make the most successful launch and going forward as I mentioned, we will start with a laser focus launch.
Speaker Change #162: So the cost to provide you. Some cogs 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 surgeons in.
Speaker Change #162: In a quality way of course also being time coaches, but we have to put the quality always first because we want to have folks basin also showing success that we see in our clinical data. So that's number one so it will not be too homely cone, but more 75 to 100 accounts and when we go a little bit more in depth.
Speaker Change #162: How do we define launch success.
Speaker Change #171: There are couple of diabetes first is breaking the monopoly thats covered these existing when it comes to Atms in the U S and expanding the <unk> market that is one overall strategy next of course, we want to exceed the street expectations.
Speaker Change #178: And who we want to make sure that we can extend our cash runway to mid 2006 with a focus on 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 <unk> from the get go and that we expect every vehicle.
Speaker Change #171: And to do minimum and implant a week if not two implants a week. So that we can then you can start modeling in your model.
Speaker Change #169: Alright, Thats very helpful. Thanks, so much.
Speaker Change #174: And our last question will come from Michael <unk> with Wolfe Research. Your line is now open.
Speaker Change #173: Hey, good afternoon, good evening I'm curious as Dr. Boon on the call.
Speaker Change #176: He is not on this call.
Speaker Change #162: Okay.
Speaker Change #168: But he will be on the Mexico, Mike you can be sure that there will also be opportunities, whether they're hosting an investor and analyst day that you kept <unk> expenses between OLED. Okay sounds good we'll leave that for then I did have one other personnel question.
Speaker Change #175: I noticed Christoph I get them unless 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 if you plan to backfill for Christophe and if so where is that.
Speaker Change #175: That process and what kind of characteristics are you looking for in a candidate.
Speaker Change #175: Yes.
Speaker Change #179: So first of all other not comment too much because out of respect also for Christophe whether you are joining us we really really worked off and did a good job, but sometimes it's not that easy to really make it pencil from a large company into a start up company, where we are because it was totally different.
Speaker Change #175: Expectations and I do think that it was the best solution for both Crystal and the soar to explore all those opportunities and for example, who waste separating mode that being said is illustrated again for us how careful we have to be in this equipment process and hope we in fact also incorporate the learnings.
Speaker Change #180: To fund I call. It the unit leaders that the U S market. This August and that also the USD real results to have a successful launch. So the process is ongoing we have several candidates that we met we all know having a shortlist and together with overbooked and also with some other members of our.
Speaker Change #180: Team, including Dr. Boom, we will be shortly announcing a new CTO and then also help us compare to the U S launch.
Speaker Change #183: Thank you so much.
Speaker Change #177: Ladies and gentlemen.
Speaker Change #181: That does conclude the Q&A session and today's conference call.
Speaker Change #182: Thank you for participating you may now disconnect.
Speaker Change #177: Okay.
Speaker Change #177: Okay.
Speaker Change #177: [music].
Speaker Change #177: Okay.
Speaker Change #177: Yes.