Nyxoah SA (NYXH) 2023 Q4 法說會逐字稿

Good day and thank you for standing by. Welcome to Nyxoah fourth-quarter 2023 earnings conference call. (Operator Instructions) Please note that today's conference is being recorded.

I would now like to pass the call over to the Investor Relations and Communications Manager, Mikaela Kirkwood.

Thank you, Carmen. Good evening and good afternoon, everyone, and welcome to our earnings call for the fourth quarter and financial year of 2023. I am Mikaela Kirkwood, Investor Relations and Communications Manager at Nyxoah. Participating from the company today will be Olivier Taelman, Chief Executive Officer; and Loïc Moreau, Chief Financial Officer.

During the call, we will discuss our operating activities and review our fourth-quarter financial results released after US 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. These statements involve material risks and uncertainties that could cause actual results or events to materially differ for 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 these risks and uncertainties associated with our business, please refer to the Risk Factors sections of our Form 20-F filed with the Securities and Exchange Commission on March 22, 2023.

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

Thank you, Mikaela. Good afternoon and good evening, everyone, and thank you for joining us for our fourth-quarter and financial year 2023 earnings call.

I would like to open with our 2023 accomplishments that have strengthened our confidence for a transformational 2024. Clinically, we completed enrollment in our DREAM US pivotal study in March and initiated enrollment in our ACCCESS Complete Concentric Collapse US pivotal study. From a regulatory perspective, we filed the first three modules in the model of PMA submission. The fourth and final module will contain the DREAM safety and efficacy data.

Commercially, we reported 2023 sales of EUR4.3 million, an increase of 43% from 2022, benefiting from our direct-to-consumer initiatives launched early in the year. We also initiated a partnership with ResMed Germany to further increase overall OSA therapy penetration and ensuring that patients have access to the right treatment. Finally, we continued building our US leadership team, strengthening our US presence.

Looking ahead, 2024 is set to be the most exciting year in company's history. By early April, we expect to report safety and efficacy results from the DREAM study. Our confidence in DREAM outcomes is supported not only by roughly 500 commercial and clinical Genio implants globally, but also by DREAM efficacy and safety data released in a late-breaking poster session at SLEEP 2023 in June.

In this poster, we reported efficacy data on the first 34 DREAM patients, reaching 12-month follow-up. We've demonstrated a 65% AHI responder rate, a 76% ODI responder rate, and safety data on all 115 patients enrolled in the study that was in line with expectations. As a reminder, for the trial to be successful, of the 115 patients, at least 62.6% need to be AHI and ODI responders at 12-month follow-up.

We anticipate submitting the fourth and final module in our model of PMA filing, which will include DREAM 12-month safety and efficacy data during the second quarter this year. We are preparing for the launch by the end of 2024 as based upon modular PMA review cycle times. We anticipate FDA approval in late '24 or early '25 as we do not control FDA timelines.

To ensure we are fully prepared at launch, we are accelerating investments in our US commercial team. We anticipate having the commercial US leadership onboarded by mid-year and bringing on our salesforce, patient management teams, and reimbursement specialists during the second half of 2024.

The current hypoglossal nerve stimulation market in the US is fairly concentrated, allowing for a focused launch strategy on high volume sites, complemented by robust prior authorization and patient care teams. A streamlined patient referral pathway from SLEEP specialists to these sites will accelerate market growth.

A key differentiator of bilateral stimulation to unilateral stimulation is the ability to treat complete concentric collapse or CCC patients. The US ACCCESS pivotal study continues to enroll. As a reminder, CCC patients represent approximately 30% of hypoglossal nerve stimulation eligible to treat OSA patients who are contraindicated to commercially available [HGNS] therapy in the US and do not have suitable treatment options other than major palate surgery.

In the BETTER SLEEP study, we've demonstrated bilateral stimulation can treat CCC patients, which led to a complete concentric collapse label expansion in Europe. Recently, Genio's success in treating CCC patients commercially was demonstrated in a real world case series that showed an average apnea-hypopnea index decrease of 73%.

The ACCCESS primary endpoints of similar to DREAM, with the objective to expand our US labeling to include complete concentric collapse indication and eliminate the need to perform a drug-induced SLEEP endoscopy to determine whether the patient has CCC or not.

Commercially, the fourth quarter was very strong with sales of EUR1.8 million, showing 87% sequential and 42% year-over-year growth. This is a result of both strong underlying demand for Genio and recent commercial investments, including direct-to-consumer online campaigns and a patient hotline.

Continued investing in understanding the patient's journey resulted in the launch of a patient helpline and kicking off our ResMed Germany collaboration to ensure every patient get the most appropriate OSA treatment. This is not only resulting in educating folks by calling the helpline but can be considered a key pillar in our fourth-quarter success together with a strong growth of sales and commercial team in Germany is doing.

In 2024, the recent ResMed Germany collaboration will further expand the OSA continuum of care, guiding patients to the appropriate therapy. For CPAP quitting patients suffering from moderate to severe OSA, Genio is a solution. And for untreated patients, CPAP remains the golden standard.

We continue to position ourselves as an innovation leader in the obstructive sleep apnea space, with always putting patients first and listening to our surgeons. As a result, Genio is a different approach to hypoglossal nerve stimulation (technical difficulty) with its lead and tough solution. Genio offers patient the leadless full-body MRI compatible, non-implanted battery solution, powered and controlled by a wearable.

Thanks to the fully upgradable wearable component, Genio patients can always have access to the most advanced technology without needing another surgery. The recently launched the Genio 2.1 enables greater stimulation adjustability and gives patients the autonomy to adjust stimulation amplitude within predefined boundaries. This will definitely help patients that are very sensitive to neurostimulation overall.

While the Genio 3.1 implantable stimulator is under regulatory review and will further support our implant for life concept. Future generations of the Genio system will have a more agronomic wearable component, have sensors that will adjust stimulation based on sleeping position, and provide patients with real-time feedback through data collection that will improve the patient experience.

We are making strong progress towards our key objectives for 2024, which are to complete patient follow-up in the DREAM US pivotal study and report efficacy and safety data by early April; file the fourth and final module on the model of PMA submission; complete patient enrollment in ACCCESS US pivotal study; continue preparations to enter the US market with regulatory, manufacturing, and market access readiness; and drive further revenue growth in Germany while opening new European markets.

With that, I'm pleased to turn the call over to our Chief Financial Officer, Loïc Moreau, who will provide a financial update.

Thank you, Olivier. Good day to everyone, and thank you for joining us today. Revenue for the fourth quarter ended December 31, 2023, was EUR1.8 million, a 42% increase over the fourth quarter of 2022 and an 87% increase over the third quarter of 2023. I would like to point out that the fourth quarter's benefit the most from seasonality. And while we expect a strong year-over-year growth in the first quarter, we anticipate sales to be down sequentially.

Total operating loss for the fourth quarter was EUR10.8 million versus EUR9.1 million for the fourth quarter of 2022, driven by an acceleration in clinical activities as well as commercial investments in Europe as well as US. As of December 31, 2023, cash and financial assets totaled EUR58 million compared to EUR95 million on December 31, 2022.

During the fourth quarter, our monthly cash burn was EUR4.9 million, a slight increase from 3Q, driven by US commercialization preparation activities. Based on our current cash position, we have runway into late 2024.

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

Thank you, Loïc. As I hope you all agree, we are entering the most exciting time in Nyxoah's history.

We are a few weeks away from DREAM clinical data readouts, which if positive, should result in obtaining FDA approval in late 2024 or early '25 depending upon FDA timeline. I look really forward to accelerating investments in the US commercial organization, so we will be ready for a late '24 launch and continued sales growth in Europe.

This concludes the formal part of our presentation. Operator, I will turn the call over to you to begin our Q&A session.

Thank you so much. (Operator Instructions) Jon Block, Stifel.

Great. Thanks, guys. Good afternoon. I'll start. The 4Q '23 top line was certainly solid, I think, ahead of most prior estimates and certainly ahead of ours. Olivier, maybe if you could just talk about what was that strength attributable to? Was it the DTC? Was it the ResMed partnership?

I think there was a competitor that had some lead issues in Germany, pardon me. So maybe if you could just talk about the main drivers or even rank order them, if you can, that would be helpful as we think about our models.

So thank you, Jon. Thank you for the question. And I can only agree. I think we can say that the fourth quarter was a very strong quarter in Germany. We estimate also that we have nearly took 50% of the German market share in the fourth quarter.

Now the drivers, I think first of all, it's a confirmation that there is a high acceptance from all the German physicians. That is one thing. Second, we have the 48 centers that are now fully trained and also implanting. We are offering doctors and patients a choice in the hypoglossal nerve stimulation implants and stepping away from an invasive pacemaker solution into a single incision procedure. This is definitely helping. Further, there is the product differentiation putting patients at the center. And of course, there is the sleep physician focus through DTC. I think those components are really driving our Q4 strong results.

Perfect, great. That was very helpful. And maybe just to pivot for the second question. You touched on some of the next steps for US approval and then commercialization. Maybe just to probe a little bit more, can you comment on the status of, call it, the first three modules, right, that have already been submitted? And then is there anything new or incremental when we start thinking about the reimbursement paths and which road you're going to go down? Thanks for your time, guys.

Yeah. No, no. So as you as you mentioned correctly, in total, there are four modules. We have submitted the first three modules already. The fourth and final module will contain the transformed DREAM safety and efficacy data and will be filed shortly in the second quarter. So the first three are done. The fourth will go hand-in-hand with the DREAM safety data.

Now when we are coming to a further market access strategy, because I think that was also part of the question, currently, 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 US. We are currently also in close conversations at the AAO who will make a recommendation on CPP codes to AMA.

There are a few different strategies. One would be using (technical difficulty) Another one would be using an existing neuromodulation code that covers our technology very well. But I think the most important is that the reimbursement in both scenarios will be in line with current [HGNS] payment rates. So I hope that is providing you an answer, Jon.

Great color. I'll jump back in the queue. Thanks, guys.

Ed White, H.C. Wainwright.

Hello. Thanks for taking my questions. Perhaps if you could just quantify if you can the impact of seasonality in the first quarter of this year that you're expecting?

Thank you, Ed, for this question. And I think the best place person to answer this is our CFO. So I'll hand it off to you.

Thank you, Olivier. And thanks for the question, Ed. So as you're aware, the fourth-quarter seasonality is driven by the phasing of hospital budgets and spending in Germany. And as you know, we do not provide revenue guidance. But last year, if you observe, the German HGNS market declined approximately 25% from the fourth quarter '22 to the first quarter '23. And we would anticipate a similar seasonality in the first quarter 2024. Given we still have high customer concentration, the impact of seasonality on our first quarter could be more pronounced. That's what we anticipate.

Okay. Thank you. And also, just to clarify, are essentially all of your sales right now coming from Germany? Is there a number you can use to quantify that?

90% of our sales in Europe are currently in Germany.

Okay, great. Thank you. And my last question is just on the ResMed. How should we be thinking about the ResMed impact and sales so far? What are you seeing? Is there any way to determine if it's having an impact already or if it should be a later in 2024 event? And also, is there the possibility of a ResMed's agreement in the US as well?

Well, thank you again for this question. Olivier, again, I will answer this -- in fact, these two questions. So first of all, in your ResMed Germany collaboration, we announced the collaboration end of September 2023. We do not expect to see an impact for the first six months. So we are anticipating beginning to realize benefits in the second quarter of this year. So that is, I think, the answer on the first part.

Now the second, do you anticipate also partnering with ResMed in the US? Our strategy is to go direct in the US. If there are opportunities to augment direct approach with partnerships like with ResMed touching on their relationship and tapping over their relationships with key physicians, we will definitely explore those in going forward.

Great. Thank you for taking my question.

Ross Osborn, Cantor Fitzgerald.

Hey, guys. Congrats on progress. Thanks for taking our questions. So starting off, just on the US market, would you walk us through how you're thinking about initially commercializing Genio in terms of targeting existing Inspire users versus growing the market? Or in other words, getting first-time HGNS users to adopt Genio? Thank you.

Thank you, Ross, for the question. I mean, we are thinking and we are preparing a lot of different strategies on this point, but I can really be precise in the answer. So the US market today is fairly concentrated. We plan a targeted launch focused on top accounts, which constitute over 85% of current HGNS sales in the US. We will have a dedicated salesforce sized appropriately for the targeted launch.

There will be targeted DTC focus on product differentiation and patient referral pathway. I think this will be a main differentiator to what is happening today. It will be really a targeted DTC focus.

We will be engaging with SLEEP specialists, enabling a steady stream of patient referrals, scalable patient follow-up strategy, and sales, marketing and prior authorization teams ahead of launch. And more details, I'm really happy to share later this year.

Okay, great. And then maybe one more qualifying question on the ResMed partnership. Would you just remind us why they're incentivized to market Genio?

Yeah. So, in fact, first of all, I would like to maybe (technical difficulty) partnership because through this partnership, we really aim both ResMed and Nyxoah and our patient-centric approach, developing a complete OSA ecosystem where patients can be guided to which ever OSA treatment that suits their needs. We will collaborate on DTC initiatives, sales and marketing efforts to target both the physicians and ENT surgeons. And I think the goal of this partnership was to expand OSA therapy penetration and increase of market share.

Now what are the benefits? I think for Nyxoah, it's pretty obvious that having access to patients who are quitting CPAP that can be offered Genio, this will drive share gains and strengthen our relationship with sleep specialists. For ResMed, benefit from having access to more OSA patients through the ENT surgeons that we are having at Nyxoah also [or helpline and] increasing sleep specialist capacity by sending CPAP struggling patients [was] time-consuming to Genio.

I think something also not to neglect is the healthcare system benefits. As untreated OSA patients are at high cost, ensuring these patients are optimally treated either with CPAP or with Genio will definitely have a positive impact on reducing healthcare spendings. And overall, this partnership will also increase our OSA therapy penetration and will benefit patients.

Great, thanks for taking our questions.

David Rescott, Baird.

Great. Thanks for taking the questions. I know you touched a little bit on the reimbursement landscape in the US. Again, I know you mentioned that September of last year at AAO, there was some discussions around new codes. Can you remind us what specifically are the next steps as you look out over the next several quarters or so around what we'll find out and when we're going to find that update out around what a US reimbursement code would look like?

Yes. No, no. Definitely. So the next step will be very precise that the AAO will make a recommendation on the CPT code to AMA. So from our side, we are working immediately to secure reimbursement from both CMS once we have FDA approval, so that we can immediately start commercializing. And in parallel, of course, preparing also commercial payers and educate and train them on the products and also convince them to start reimbursing our technology.

Now, our competitor, as you know, has done a terrific job educating the commercial payers about the benefits of HGNS, resulting in all having HGNS coverage policies. We have already engaged in an informal discussion with the payers and expect (technical difficulty) those policies. At launch, very precise, we anticipate being reimbursed to prior authorizations and would expect to be included in total coverage policies with commercial payers within 12 months afterwards.

Okay. And then you mentioned some investments in the sales force ahead of the US launch. I heard you also mentioned some investments in manufacturing. I'm curious what specifically is going on from the manufacturing side, And historically, I think you talked about this $4 million of quarterly cash burn. Is that kind of the right way to think about that into 2024? Or should there be some type of acceleration assuming that you continue to invest in some of the sales force and manufacturing capabilities ahead of a US launch? Thank you.

Yeah. So first part is on the manufacturing side, we really invested heavily. So we have now a complete approved site in Belgium, manufacturing of products. And next to this, we are working with a service provider in the US that will also manufacture or will also manufacture our products.

So with both sides, we do believe that we totally completely have de-risked the manufacturing volume capacity, that we will be able to start building inventory before we launch. So that at all time when we launch, we will have significant inventory in our possession that there will never be a product shortage in the first 12 months of launch. That is one thing. When it comes to the cost relating to this and the overall spend, Loïc, I'm sure that you would like to comment on this a little bit further.

So you have seen that we burned EUR4.9 million in the last quarter of 2023. When we look forward, we expect the burn rate to remain steady for the first half of the year, while we are started doing our pre-commercial investment. And then when we -- starting this summer, we expect this burn rate to accelerate as we see more and more investments in US commercialization activities.

Okay, great. Thank you.

Adam Maeder, Piper Sandler.

Hi, good afternoon. Congrats on the nice finish to the year and the recent progress. And thanks for taking the questions. I wanted to start on the DREAM study and just the disclosure strategy around full DREAM results. So I heard the data should be communicated by early April.

Olivier, are you able to talk a little bit more about exactly what's going to be shared at that point in time? Is it simply just top-line information? Will we get additional details? I'm assuming that's going to be messaged in the form of a press release, but maybe just talk about disclosure strategy and then I had a follow-up. Thank you.

So thank you, Adam, for the question. So as I mentioned, and I knew we will communicate latest beginning of April the data. That will be in a press release followed also by a call. We will be focused on top-line results, AHI reduction, responder rate, ODI reduction. And then we are planning in moving forward to reveal all the data in detail during the ISSS conference in September, where we will have PI talking (technical difficulty) to the data and the detail.

So what you can expect is top-line data being released in a press release, followed also by a call, whether there can be more questions. And we will be focusing on, in fact, responder rate, AHI reduction, ODI reduction. We will also talk high level on the safety data that we are having. And then, of course, in parallel, we are preparing everything for publication in the Tier 1 journal.

That's perfect. Thank you for the color, Olivier. And then for the follow-up, I wanted to ask about the ACCCESS study. I think it was mentioned in the prepared remarks, but was hoping just to get a little bit more granular in terms of enrollment progress in that study.

How should we think about potential timelines for enrollment completion and ultimately potential FDA commercial approval for CCC patients? Thank you for taking the questions.

So we continue to make progress with the study. We will not disclose the number of patients implanted already. But that being said, we still continue to plan to close all implants by the end of '24.

Then there is a 12-month patient follow-up. So that brings us to the end of '25. And then the aim is to submit the CCC data as a PMA supplement. That should take maximum six- to nine-month review period. So we plan to have the label expansion, assuming all data positive mid-2026.

Very helpful. Thank you.

Laura Roba, Degroof Petercam.

Hi, thank you for taking my question. We see that gross margin was lower in Q4. Could you elaborate a bit on that and what we could expect for 2024?

Definitely. And this is definitely a question for our CFO.

Thank you, Laura. Yes, indeed, we were at 60% in Q4 versus 62% for the rest of the year. Actually, this is explained by our scale and specifically the fact that we have a newly opened manufacturing site in Belgium, that is not yet at full capacity. So we see some modest variability quarter over quarter.

That said, we anticipate the gross margin to increase over the coming quarters as we scale up volumes. Over time, we expect our gross margin to eventually approximate the level of other neural stimulation companies and to be above 80%.

Okay. That's very clear. Thank you.

Suraj Kalia, Oppenheimer.

Olivier and Loïc, can you hear me all right?

Yes, we can. Hello.

Yes.

Pardon the background noise and congrats on the progress. So Olivier, a few questions from my side. As we look forward to DREAM, Olivier, what would you say in your position -- say, the results are -- how can you characterize the delta between bilateral versus unilateral? What would make you say these results are better than unilateral? What would make you say these are somewhat less than unilateral?

So if I understand the question correct, Suraj, because there is a little bit background, so you're asking the result comparison between bilateral result and unilateral result that we are seeing. Is this correct?

Yeah. I guess what I'm trying to understand, Olivier, is you can -- rest assured, the numbers are going to be sliced and diced 10 different ways to make different arguments, right? I guess what I'm trying to understand is hypothetically, if you have 50% responder rate in the complete cohort, Inspire had a certain responder rate. We can slice and dice different metrics. What would make you say, you know what, this is -- the totality of these results show bilateral is better than unilateral. What would make you somewhat cautious and say, you know what, we missed somewhere versus unilateral?

Yes. So I -- first of all, I have to point out that the study was not designed to show superiority and it was even not a head-to-head trial. But on the other hand, you are totally --

No, I get it.

Okay. Those are the patient phenotyping. We look at the inclusion criteria, we look at the BMI criteria. So the studies are really similar or comparable.

Now what would we expect? So if we can show -- and that's what we already communicated -- first of all, of course, reaching the primary endpoint. Second, showing equivalence compared to the unilateral stimulation for non-CCC patients. I think that would be already a first accomplishment. When you look at what the responder rate would mean, in our case, we look forward and we actually show a responder rate of 62.6%. So I would like to see numbers, of course, above. That is one thing.

And then second, there will also be a lot of analysis that will be done on AHI reduction. What is the AHI reduction for patients with a higher BMI or patients with a BMI that is, for example, 25 and then going lower? So I think this is really important.

Let's also not forget the ODI reduction because there is (technical difficulty) that oxygen saturation and the mortality risk. So I think this is important. And of course, all reductions have to be clinically relevant. So that's what we are looking at.

So equivalence, that's what we would like to claim. We would further slice and dice the data and looking on AHI reduction. There is also the supine position that we are seeing and how the reduction is this because during at night, patients, they tend not to stay only on one -- in one position, but to toss and turn little bit. So also there, we will come with a sub-analysis. So that's what you can expect from our data.

Got it. And Olivier, I'll quickly -- with my follow-up question and avoid the background noise. So Olivier, do you expect Genio eventually to be used in patients who are unwilling to try CPAP? And also, what has been the experience in Germany? Are they more female gender usage is higher than male just given beard issues? Thank you for taking my questions.

So first of all, we have to follow the current guidelines, and that means that patients need to be refractory or quitting CPAP. So that is one thing. So will we become first line? I think in order to do this, HGNS needs to change those guidelines. But for now, it's clear that patients have to have CPAP before they become eligible for an HGNS treatment.

So when it comes to the gender of patients, so also there, we still see that the majority of patients are male and not female. And when it comes to add to the fact, what you were alluding (technical difficulty) we also -- there we can confirm that patients who are suffering from moderate or severe OSA and offer the Genio solutions are really happy to share -- if I can say it like this -- so that they can really benefit from our technology or from the bilateral stimulation as it is recommended by their surgeons and physicians. So I hope that this is answering your question.

Thank you. And with that, ladies and gentlemen, we conclude our Q&A and program for today. Thank you all for participating, and you may now disconnect.