Nyxoah Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
November 8, 2023

There are 10 speakers on the call.

Operator

Good day, and thank you for standing by. Welcome to the Nextiva Third Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's call is being recorded.

Operator

I would now like to hand the conference over to your first speaker today, Mikaela Kirkwood, Investor Relations and Corporate Communications Manager. Please go ahead.

Speaker 1

Good afternoon and good evening everyone and welcome to our earnings Call for the Q3 of 2023. I am Mikaela Kirkwood, Investor Relations and Corporate Communications Manager at NextElla. Participating from the company today will be Olivier Talman, Chief Executive Officer and Alik Moreau, Chief Financial Officer. During the call, we will discuss our operating activities and review our Q3 financial results released after U. S.

Speaker 1

Market closed today, After which we will host a question and answer session. The press release can be found on the Investor Relations section of our website. This call is being recorded and will be archived in the Events section of the Investor Relations tab of our website. Before we begin, I would like to remind you that any statements that relate to expectations or predictions of future events, market trends, Results or performance are forward looking statements. All forward looking statements are based upon our current estimates and various assumptions.

Speaker 1

These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these 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 on our Form 20 F filed with Securities and Exchange Commission on March 22, 2023. With that, I will now turn the call over to Olivier.

Speaker 2

Thank you, Mikaela. Good afternoon, and good evening, everyone, And thank you for joining us for our Q3 2023 earnings call. During the Q3, We maintained focus on clinical execution in our open label U. S. Pivotal study DREAM, ensuring a steady course to complete data readout In March 2024, based upon the DREAM data published back in June, in combination with commercial patient outcomes in Europe, Our confidence is strengthened for a positive dream outcome.

Speaker 2

In anticipation of our U. S. Launch, We have made great progress as we continue to work with the AAO Medicines on our interim and long term coding strategy. Next, we continue to invest in gradually building our leadership in the U. S.

Speaker 2

Commercial organization, including market access To facilitate reimbursement. In Europe, we recently introduced a novel patient centric approach By initiating a partnership with ResMed Germany. Together, we will strengthen our in-depth understanding of the obstructive sleep apnea patient journey, Increasing patient overall OSA awareness and guiding them from diagnosis to treatment. While CPAP remains the golden standard, there is a large pool of patients not tolerating it and needing therapy due to the severity of their OSA. Through this partnership, we aim to increase hyperosal neurostimulation penetration and accelerate Genio adoption.

Speaker 2

Now with that said, Nixoa is entering one of the most exciting times in the company's history. In less than 6 months, we will report data from our DREAM U. S. Pivotal trial. We recently filed the 3rd module in our modular PMA And continue to anticipate submitting the 4th and final module, which will include DREAM 12 month safety and efficacy data Shortly after the follow-up period is completed, we remain on track for FDA approval before the end of 2024.

Speaker 2

In anticipation of this, NixoA continues to expand its U. S. Footprint. On patient follow-up in DREAM. As previously stated, our confidence in DREAM outcomes is supported not only By the roughly 500 commercial and clinical genomes include GMA globally, but also by the DREAM efficacy and safety data Released in a late breaking poster session at SLED 2023 in June.

Speaker 2

In the poster, we reported efficacy data on the first 34 DREAM patients reaching 12 months follow-up, which demonstrated a 65% And the 76% ODI responder rate and safety data on all 115 patients enrolled in the study. As a reminder, for the trial to be successful of the 115 patients, at least 62.9% Need to be AHI and ODI responders at 12 month follow-up. Next, the U. S. Access Pivotal study focused on complete concentric collapse patients continues to enroll with implants expected to be completed in 2024.

Speaker 2

As a reminder, CCC patients represent approximately 30% of hypoglossum neurostimulation eligible to treat OSA patients who are contra indicated to commercially available AGNS therapy in the U. S. And do not have suitable treatment options other than major palate surgery. The access primary endpoints are similar to the DREAM study primary endpoints As Gino has demonstrated similar results in both complete concentric collapse and non CCC patients, which resulted in a label expansion in Europe. While entering Germany, NixoVA drove reprosal neurostimulation awareness and therapy penetration, Increasing market growth from an estimated 15% to 35% over the last 2 years.

Speaker 2

This clearly illustrates the benefit of having multiple ribosome neurostimulation treatment options and having multiple companies on the market. To further our patient centric approach to treating more OSA patients with the right solution, as I mentioned earlier, We partnered with ResMed Germany. This model partnership creates an OSA continuum of care That will shorten the time from diagnosis to treatment and ensure patients are not left without an appropriate therapy. As an example, there are approximately 1,100,000 CPAP patients in Germany, of which up to 35% fail within 3 years. This collaboration should increase the number of patients in Germany receiving and staying under OSA therapy.

Speaker 2

Completely, to increase patient awareness, we will collaborate to always say help lines and DTC marketing initiatives. We will run joint Salesforce efforts towards ENT surgeons, sleep physicians and dentists as well as educational programs. Both companies will work closely with scientific societies to further optimize patient care guidelines. In conclusion, this Initiative exemplifies our mission to make sleep simple again. Commercially, This quarter, we reported sales of €1,000,000 and increased the number of German centers in Planting Genio to 46.

Speaker 2

Our direct to consumer campaigns started in the Q2 this year resulted in a strong website traffic with approximately 55,000 Monthly website visits. We are anticipating the first results from these initiatives already in Q4 later this year With strong year over year implant growth, we continue to position ourselves as an innovation leader in the OSA space With always putting patients at the center and listening to our surgeons. As a result, Genu has a different approach to AGNS Compared to existing implanted battery with lead solution technology, Genio offers patients a leadless Full body 1.5 Tesla and 3 Tesla MRI compatibility, non implanted battery solutions, Powered and controlled bio wearable. Our vision of an implant for life concept, Powered and controlled bio wearable component All our patients to always have the most advanced technology without the need for another surgery. Independent patient market research confirmed preference for a system with Jynneo features and form factor.

Speaker 2

The recently launched Jynio 2.1 wearable enables greater stimulation adjustability And gives patients the autonomy to adjust stimulation amplitude within predefined boundaries. While the Jynneo 3.1 Implantable Stimulator is under regulatory review and will further report our Implant for Life concept. We are also working on regulatory approval to activate existing sensors in the wearable component That will adjust stimulation based upon sleeping position. Future generations of the Genio system We'll provide patients with real time feedback through data collection and offer remote monitoring that will improve the patient experience And provides physicians the ability to optimize patient care more efficiently. All this should further increase patient access to hypoglossal nerve stimulation technology and have a positive impact on the company's gross margin.

Speaker 2

Our European commercialization experience, Early DREAM data and Genio's differentiated design reinforce our confidence in a successful U. S. Launch. We commissioned independent clinician and patient service, which demonstrate significant demand for Jynneo and support our view that we can More than replicate our European performance when entering commercially in the U. S.

Speaker 2

To ensure we are fully prepared at launch, We continue to invest in our U. S. Commercial infrastructure and securing reimbursement. Last month, an advisory panel For the ENT Scientific Society, discuss the CPT code that will best support Genio. While the outcome of the meeting, We expect reimbursement to be at the minimum in line with the current AG and F payment rates in the U.

Speaker 2

S. Finally, we are making steady progress with our Anta cervicalis program through our exclusive licensing agreement with Vanderbilt University. Under the lead of Professor David Gantt in close collaboration with the NexoA R and D team, we are evaluating stimulation of the antacertregalis nerve To address current AGNS non responders, we have entered the detailed design phase and anticipate beginning a feasibility study shortly. In summary, we continue to advance our key objectives for 2023, which are to focus on patient follow-up in the DREAM study resulting In reaching the primary endpoint, begin preparations to enter the U. S.

Speaker 2

Market with regulatory, manufacturing, Commercial and market access readiness and drive further revenue growth in Germany while opening new European markets. To that end, we implanted our first patients in Italy. With that, I'm pleased to turn the call over to our CFO, Louis Morreau, Who will provide a financial update.

Speaker 3

Thank you, Olivier. Good day to everyone, and thank you for joining us today. Revenue for the Q3 ended September 30, 2023 was €1,000,000 Total operating loss for the Q3 was €11,000,000 versus €8,800,000 in the Q3 of 2022, Driven by an acceleration in clinical activities as well as commercial investments in Europe. As of September 30, 2023, cash and financial assets totaled CAD 73,000,000 Compared to $95,000,000 on December 31, 2022. During the Q3, Our monthly cash burn was €4,000,000 And based on our current cash position, we have a runway into late 2024.

Speaker 3

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

Speaker 2

Thank you, Louis. As I opened it, We are entering one of the most exciting times in Xolair's history. I cannot emphasize this enough. We are less than 6 months away from the DREAM clinical data readout, Which should result in obtaining FDA approval in late 2024 and in addition with reimbursement Comparable to competition, the uniqueness of Jynneos system resonates well with both physicians and patients as we are In the U. S, Germany and other markets where we are available, also confirmed by Independent Market Research.

Speaker 2

I look forward to continuing to scale the company In anticipation of this market and continuing to grow in Europe. This concludes the formal part of our presentation. Operator, I will turn the call over to you to begin our

Operator

Our first question today comes from Jon Block with Stifel. Your line is open.

Speaker 4

Hi, everyone. This is Joe Federico on for John. Thanks for taking the questions. I guess to start, I wanted to ask, I know GLP-one has been a hot topic lately. Do you have any expectations for the surmount OSA data that is Supposed to be released early next year.

Speaker 4

We've heard some commentary from other players in the space. I was just curious to get your thoughts there.

Speaker 2

Yes. No, thank you for the question. And to confirm, there was a lot of there is a lot of conversation around GLP-one impact. So I keep giving the same and providing the same answers, meaning that by having GLP-1s lowering extreme high BMIs, We think and we know that we will have more patients that will become eligible for a successful AG and A treatment because if we look at literature, AGLS is shown the most effective with the BMI up to 35. So high BMIs Lowering in the range of 30 to 35, we will provide those patients with an optimal treatment of AGNS.

Speaker 2

And if you look at it net net, We do believe that we will have more patients entering in that range than we will have patients that will go in a range below 15 And no longer be eligible for treatment.

Speaker 4

Okay, great. That's really helpful color. And I guess to follow-up, I just wanted to follow-up on the ResMed partnership in the quarter, there is what are you seeing after implementing that partnership? Is it still early to tell or have you seen any benefits

Speaker 2

So through the partnership, we aim to further our patient centric approach By developing a complete OSA ecosystem where patients can be guided to whichever OSA therapy best suited the needs. I think this is really important. We will collaborate on DTC initiatives, sales and marketing efforts to target both sleep physicians and ENT surgeons. The goal of this partnership was to expand OSA therapy penetration and increase market share. The collaboration just kicked off and we expect to start to see the benefit beginning next year.

Speaker 4

Okay, great. That makes sense. And then if I could just sneak one last one in here on access in the U. S, Are there any other data points from the trial that you can provide maybe patients implanted to date or number of active sites? Just any more color there would be great.

Speaker 4

Thank you.

Speaker 2

So when it comes to the access study, we are staying confident that we will close the enrollment by the end of 2024. So that's why that's when we anticipate completing the implants. We continue to make progress with the study. We will not be disclosing the number of patients implanted. But that being said, I repeat myself, we do feel confident that we will close all implants by the end of 2024.

Speaker 4

Okay, great. Thank you for the questions.

Speaker 2

Thank you.

Operator

Thank you very much. Our next question is from Adam Nader with Piper Sandler. Your line is open. Adam, your line is open.

Speaker 5

Hi, Olivier. Hi, Louis. This is Simran on for Adam. Thanks for taking the questions. I guess first, I wanted to just start off with The Q3 kind of commercial print.

Speaker 5

So could you elaborate on Maybe what you're seeing in terms of just commercial trends, it looks like Volumes did take a step back sequentially. So any particular items to call out or Seasonality impact, I guess, I'm just trying to reconcile some of the disconnect between What the Street was expecting versus the print?

Speaker 2

Yes. No, no, definitely. So while we do not provide revenue guidance, it is important to mention that Q3 is seasonally weak due to summer holidays. However, for implanting accounts continue to increase, now being 46, which bodes well for the future growth. We do anticipate also a sequential increase in the 4th quarter, driven by the DTC initiatives That we started in the Q2, driven by the helpline outcome that we are seeing.

Speaker 2

And of course, although it may become a little bit early, but also about The collaboration that we have initiated with RASMAD.

Operator

Thank you very much for your questions. One moment please. Our next question comes from Ed White with H. C. Wainwright.

Operator

Your line is open.

Speaker 6

Hi, thanks for taking my questions. So I just want to get your thoughts on the DTC activity in Germany. You mentioned in the call that you had about 55,000 monthly hits. And I was just wondering how you're thinking about that converting into commercial sales? And then I wanted to get your thoughts also On DTC potential DTC activity in the U.

Speaker 6

S?

Speaker 2

Yes. So thank you. Thank you for the questions. So to your point, we invested in dedicating and building up a dedicated digital marketing team focused on Germany As we launched the Nexoah helpline in Germany last year, we engaged resources in the search engine optimization And the search engine advertising, this is really driving more patients to NYX-one. So that's already a first part of investment we did.

Speaker 2

And then next, our DTC advertising campaign was launched in March and has raised awareness for AG and S and Genio. As a result, we have seen a rapid growth in appointments request through our helpline. The current time from patient identification to Genio implant or the conversion time as it sometimes referred to in Germany is 6 to 8 months. So we anticipate beginning next quarter to see a real strong benefit. When it comes to the U.

Speaker 2

S, I think I have to start with saying that Inspire from a DTC perspective did or has done a tremendous job Establishing the AGNS market for patients, physicians and payers in the U. S. In this regard, it is sometimes nice to be number 2 Entering the market, we anticipate having our full sales force hired and trained by the time of launch. These reps will target both implanting ENTs And referring sleep physicians supported by focused DTC investments and I think that's really important. So we are planning To invest in DTC, we will be very focused.

Speaker 2

Additionally, we are currently investing in market access to ensure CMS Reimbursement is secured at launch and to expedite commercial coverage. Sorry for being a little bit long, but There were also 2 questions.

Speaker 6

No, that was great. Thanks so much for taking my questions.

Operator

Our next question comes once again from Adam Maeder with Piper Sandler.

Speaker 5

Hey, I just wanted to follow-up with another question On just reimbursement, so from a reimbursement perspective, can you remind us, 1, on the coding, it sounded like last quarter that you would have a clear idea of what that code is by year end. Is that still the case? And then 2, just what is the strategy in Terms of garnering payer coverage and what kind of initiatives are you guys putting in place To kind of work up to that, so that everything is squared away or by launch?

Speaker 2

Yes. So last month at the AAO meeting in Nashville, An advisory panel for the ENT Scientific Society discussed the CPT code that would best support Genio. And to your point, This is one of the scenarios that I was mentioning earlier that has now been put more forward. So multiple CPT codes were evaluated And while I cannot yet disclose the complete outcome of the discussion, we expect reimbursement will be at minimum in line with the current AG and S payment rates. So that is already I think the first answer.

Speaker 2

Next, I have to again say that competition has done a terrific job educating the commercial payers about the benefits of AGNS, resolving in all having AGNS coverage policies. We have already engaged in informal discussions With payers and expect to be able to leverage those policies. At launch, we anticipate being reimbursed through prior authorizations Helen would expect to be included in coverage policies within 12 months afterwards. Now very concrete from a market access perspective, We have a team in place that is working to secure reimbursement from both CMS and the commercial payers. That team will also work with customers through the prior authorization process when we launch in the U.

Speaker 2

S.

Speaker 5

Okay, great. Thank you so much.

Operator

Thank you very much. Our next question comes from Suraj Kalia from Oppenheimer and Company. Your line is open.

Speaker 7

Hey, Olivier, this is Seamus on for Suraj. Hello.

Speaker 4

Hi.

Speaker 6

So

Speaker 7

I believe earlier you said that the you had submitted the 3rd module to the FDA. Have you received any Questions on the submission so far? Any feedback yet that you can share with us?

Speaker 2

So the short answer is yes. We did receive some deficiency questions on module 12. We answered them and they will also be submitted shortly. So just to summarize and as a reminder, you know that there are 4 modules in total. The first module was more qualitative review and preclinical data.

Speaker 2

We submitted. We got some questions. Nothing that is worrying us in the sense that we do feel extremely confident and we also have answered all these questions. 2nd module, same thing, remaining preclinical data. Also there, we got, I think, I can say the normal or the expected questions that we are answering.

Speaker 2

And then now with the perf module, it's more on manufacturing and the manufacturing validation. So it was submitted a week ago. Now the last one and that's why it gets really exciting. So module 4, it will be the final module and that is the one we can submit with including clinical data review and IFU labeling And we expect to do this somewhere end of March beginning April after we have the time to analyze the data that we will have in the 1st week of March

Speaker 7

Got it. Thank you for that. Looking at Germany and kind of the competition there, There's some overlap. I know you've discussed it before between you and a competitor. So in those sites, What's the driving factor for those accounts saying I'm going to implant a patient with Genio versus one of your competitors' systems?

Speaker 2

So I first I would like to point out that in quarter 3, we are still estimating that our market share stays in the range of 20% market share during the quarter. I think this is a first really important point because as you know since we entered the German market 2 years ago, with having also CPT codes, we were able to immediately capture 20% to 25% market share And this has been continuing always being in this range with a strong Q4 where we were slightly above 30%. So that is already the first part to your question. So if you look at implant sites that we are going after as a fast follower in sites where INSPIRE already was Several years active, we see that in those sites or in all sites, we are able to take market share in a significant way. That's number 1.

Speaker 2

Point 2, what we are seeing is when you go to higher volume sites, we also saw that in the top 5, We were able to take more market share than the 20%. So there was even stronger uptake in some top implanting sites in Germany. Now, I think when you have competition entering and there is a monopolistic market, you also can increase Overall, HRS penetration and I'm really pleased to see that we are driving this because that is something that we are hearing back from surgeons as well. First, they are extremely pleased that there is no option to choose between 2 therapies. 2nd, by having this option and also seeing that more patients Or being treated with one of those 2 results, we have increased therapy penetration.

Speaker 2

And I keep repeating and I have to come back to the uniqueness of our system that a single incision, a CCC indication, a full body MRI Compatibility and also real patient centric approach is really something that is speaking very positively to physicians and patients. So forward to the next quarter, we are looking forward to beginning 2024 also in Europe commercially to see the impact of the And of course, to also further expand into new and other countries. And to that point, I'm sorry that I keep going, but to that point, We also have some good news coming from the U. K. Where we are now officially allowed to participate in an NHS standard.

Speaker 2

So that will also definitely help us accelerating revenue in Europe coming from more countries than mainly Germany.

Speaker 7

Yes. I appreciate all the color there. And if I can sneak one more in, just kind of looking when you do the U. S. Launch, I know it's a little ways away, but I know you said about 100 to 150 reps.

Speaker 7

How many sites are you looking to initially launch at? How many centers? Just trying to tie the color of centers to reps, so to speak.

Speaker 2

Yes. So although I would really love to answer your question, think you can understand that I do not want to be going too concrete to that question for a simple reason that 2024 will be the year Well, based on successful DREAM data, we will have FDA approval later at the end of the year and hopefully also start commercializing. Currently, we're looking at a couple of scenarios. One scenario is where we would go of course with a kind of focused launch and try I go immediately after, let's say, roughly half of the Inspire side that we have today. On the other hand, it's also not a When you look at productivity for a sales rep whether it now is with a Vipinixor or with another neuromodulation company, we would be aiming to have $1,000,000 of sales by sales rep.

Speaker 7

Got it. Thank you very much for taking our questions.

Speaker 2

Thank you for the question.

Operator

Thank you. Our next question comes from David Rescott with Baird. Your line is open. Great.

Speaker 8

Hey guys, thanks for taking the questions. I wanted to start off on the partnership that you announced a couple Weeks ago, I'm curious, I know it's I mean, it seems like it's something that can be pretty exciting. I know it's a couple of weeks You're so into it since the announcement. I'm just curious if you're at a point yet where Things are kind of established and maybe you're starting to see some patients start to either roll in specifically to Nyxoah, maybe through the partnership at all, or if there's anything anecdotal that you can provide just around how that maybe already is Starting to impact the business or maybe if it's a couple more quarters still before the potential benefits from that partnership could be realized?

Speaker 2

Yes. So first, since it's really important, I think it's difficult to exactly predict When we will see what kind of impact. But what I would like to come back to and I think this is something where I also would like to give a lot of credit To the ResMed colleagues in Germany, it is really putting a patient at the center, really further looking beyond CPAP, the porosol nerve stimulation, mandibular device treatment, now what is exactly and precisely the best solution for Our patient is Safri from OSA. And therefore I keep repeating CPAP is the golden standard. It works excellent, but the issue is that A lot of patients simply quit their CPAP after a period of time.

Speaker 2

Now if these patients are suffering from moderate to severe OSA, it is So important to offer them a treatment. We all know the cardiovascular risks that are associated with the risk of stroke, the cost for healthcare systems if you do not treat patients Suffering from moderate to severe OSA. So I'm really proud in one hand that we can say that together with ResMed in Germany, We are really looking at what is best for the patient. Now that being said, it's also clear that we need to, 1st of all, start and get used to each other a little bit. That is ongoing.

Speaker 2

Sales teams are talking with each other. Marketing teams are talking with each other. We are looking at DTC initiatives. We have the 1st major congress coming up in Berlin where we both will be present and interacting with several KOLs. And I think a realistic approach would be that you would see the first impact in overall patient penetration increase and GEMEO specific Increase as of Q1 next year.

Speaker 8

Okay, great. That's helpful. Just on access in the U. S, I'm wondering the level of visibility maybe you have into that trial. I know that with This kind of complete Concentra collapse patient population there maybe is a higher concern around those patients having Higher BMIs and maybe there being a bigger impact from GLP-1s.

Speaker 8

So just wondering what Level of visibility you have into that and whether or not you have a better informed view maybe on what the potential impact could be Either into that specific patient population or just broadly across all nerve stimulators? Thank you.

Speaker 2

Yes. So let me start with first with some facts. So in the access study, we have protocol with up to 40 sites that will implant. Although we do not anticipate activating that many, we have so far activated 4 sites, but we can go up to 40. That's step 1.

Speaker 2

2nd fact is that we are feeling comfortable that we will close the enrollment by the end Of 2024. Everything is going in this direction. So it's trending really in a positive way. So another fact is that in the ACCESS study or BMI or BMI the patient's BMI cannot be above 35. I think this is important.

Speaker 2

As I already was commenting earlier, we believe and we see this in clinical literature that to have an optimal therapeutic effect From AGNS, a patient should not be having a BMI that is higher than 35. What we also learned is That patients suffering from CCC and also the correlation with their BMI is present. So we see that we have a lot of patients with a BMI somewhere in the range of 30 to 35. Now what you can expect Is that there are also quite some patients with a BMI above 35 that are suffering from CCC. And that is precisely why we where we are seeing a very positive impact from GLP-1s because And if you speak to KOLs what we did extensively, we're also hearing there that it's clear that lower a BMI That is above 35, bring the patient in the range of 30 to 35 implant with AGNS and have a successful therapeutic response.

Speaker 2

Physicians are more behind that concept than increasing or implanting patients with a BMI above 35 And where there is a risk that there will be not a strong therapeutic response. So I'm welcoming honestly the GLP-one impact To lower and to bring those really obese patients into this range below 35 and then Regardless if they suffer from CCC or non CCC, with Genio, we know that we can offer them a successful therapeutic solution.

Speaker 9

Okay, great. Thanks.

Operator

Thank you for your question. Our next question comes from Ross Osborne with Cantor Fitzgerald. Your line is open.

Speaker 9

Hi, guys. Thanks for taking our questions. In terms of commercialization activities outside of Germany, would you provide an update on how Spain is receiving your system following first implant this summer. Additionally, I would be curious to hear what other countries you had implants in during the quarter in addition to Italy Where are we should be thinking about for the balance of this year 2024? Thank you.

Speaker 2

Yes. So To your point, so today we are reimbursed in Spain, in Switzerland and also, of course, In Germany, where we generate like 95% of our revenue. In going forward, we did first Italy, Because in Italy in order to obtain reimbursement, there was a demand for country specific data and that's why we did the first patients already. We are going up to 10 patients in Italy. And then based on these data, we will submit them together with the existing data.

Speaker 2

And hopefully, this will result Also in a reimbursement in Italy. In the Nordic countries, same thing goes for Finland. So there we did some implants already. And based on these data, we are trying to secure hospital reimbursement, hospital by hospital and also generate more commercial implants in Finland. And what I was mentioning earlier on, I think a very important market will be the U.

Speaker 2

K. First step to enter the U. K. Is To being allowed by NHS to participate in the standard, we have received this official communication that we are now the next steps will be How to compete in this standard and how to make our case strong so that we can handle. So that's in a nutshell where we are and where you can expect us to be reimbursed Sure.

Speaker 9

Great. Thank you.

Operator

Thank you very much for your questions. I am showing no further questions at this time. Thank you for your participation in today's conference. This does conclude the program. Enjoy your evening and you may now disconnect.

Speaker 3

Thank you. Thank you.

Powered by Quartr

Key Takeaways

  • On the clinical front, the U.S. pivotal DREAM trial remains on track with data readout expected in March 2024 and the third PMA module filed, supporting an FDA approval goal by late 2024.
  • Preparations for the U.S. launch include active coding strategy discussions with the AAO, building a U.S. commercial team, and focused market access efforts to secure reimbursement in line with current AGNS therapies.
  • In Europe, a new partnership with ResMed Germany aims to create a seamless OSA continuum of care, while direct-to-consumer campaigns and an expanded implant network (46 centers) drove €1.0 M in Q3 revenue.
  • R&D progress includes the ongoing U.S. ACCESS trial for complete concentric collapse patients (enrollment through 2024) and advancement of an ansa cervicalis nerve stimulation program under a Vanderbilt University license.
  • Financially, Q3 revenue was €1.0 M with an €11.0 M operating loss, and cash and financial assets of CAD 73 M support a runway into late 2024 given a €4.0 M monthly burn rate.
AI Generated. May Contain Errors.
Earnings Conference Call
Nyxoah Q3 2023
00:00 / 00:00