Nyxoah S.A. (NYXH) Q1 2022 Earnings Call Transcript

Nyxoah S.A. (NYXH -11.52%)
Q1 2022 Earnings Call
May 10, 2022, 8:00 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Thank you for standing by, and welcome to the Nyxoah first quarter 2022 earnings conference call. [Operator instructions] I would now like to hand the conference over to your speaker today, Mr. Jeremy Feffer. Thank you.

Please go ahead, sir.

Jeremy Feffer -- Investor Relations

Thank you, Justin. Good afternoon, everyone, and welcome to our earnings call for the first quarter of 2022. Participating from the company will be Olivier Taelman, chief executive officer, and Loic Moreau, chief financial officer. During the call, we will discuss our operating activities and review our first quarter financial results released after U.S.

markets closed on May 9, 2022, after which we will host a question-and-answer session. The press release can be found on the investor relations section of our website and this call is being recorded and will be archived in the event section of our investor relations website. Before we begin, I would like to remind you that any statements that relate to expectations or predictions of future events, market trends, results, or performance are forward-looking statements. All forward-looking statements are based upon our current estimates and various assumptions.

These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. All forward-looking statements are based upon current available information and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the risk factors section of our form 20-F filed with the Securities and Exchange Commission on March 24, 2022.

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

Olivier Taelman -- Chief Executive Officer

Thank you, Jeremy. Good morning and good afternoon, everyone. And thank you for joining us for our first-ever quarterly earning call. We are excited to move to a quarterly earning call schedule and give more Quicken update.

And I am especially happy to share our first quarterly results as we made very strong quarter toward achieving the key strategic objectives for 2022 that we laid out in our prior call. Allow me to quickly remind you of these key objectives. Completing the DREAM trial implants in the second quarter of 2022, accelerating commercial institution in Germany and commenting the U.S. IDE study for complete concentric collapse in the fourth quarter of 2022.

I first would like to acknowledge our dedicated team for their strong execution resulting in acceleration during Q1 on all our strategic priorities. Our Q1 call was mainly be focused on DREAM enrollment acceleration and the rapid growth we saw in our European sales. Starting with our commercial performance in Germany, I'm proud to report that sales growth accelerated significantly during the quarter. We generated EUR 660,000 in the first quarter of 2022, which represents year-over-year growth of more than three and a half times and more than double what we achieved during Q4, the previous quarters in 2021.

Knowing the Omicron variant was still impacting procedures across Europe during January through roughly mid-February of overall strong Q1 performance underscores the execution focus by our commercial team. Even more powerful in our view is the impact we are having in the German market. As a reminder, our commercial proof of concept will be to become market leader in Germany by the end of 2022. Our first quarter performance also exemplifies what we mean by ongoing deep commercial strategy of targeting and developing sample of excellent.

Exiting Q1, we had 15 active implant sites in Germany, a 25% growth over Q4 for 2021, and we expect to add an extra 10 accounts by the end of Q3, bringing the total to 25 active German implanting accounts. Looking at our Q1 revenue, we estimate based on our knowledge of the German market, we achieved approximately 25% market share in Germany in the quarter, which is more than double of market share compared to the previous quarter. For the quarter to come, we expect to further accelerate the revenue ramp by increasing therapy penetration in the existing side, opening more centers of excellence, and further strengthening our relations with implanting EMT surgeon and referring sleep physicians. Additionally, we expect to see the first result from our direct to patient's effort and we will continue putting the patient first.

Highlighted by having the only muscle knowledge stimulation therapy with a full body 3.0 MRI compatibility. We have also experienced strong tailwind as a result of the positive, BETTER SLEEP data on complete concentric collapse and non-CCC patients that we presented in March during the World Sleep Congress in Rome. This event gave us an invaluable opportunity to interact with 55 international KOLs during an exclusive event we hosted in parallel to the congress. Among the most important takeaways from world sleep was how many physicians expressed excitement that they now have an option to treat their complete concentric collapse patient whom they previously had to turn away.

We are thrilled to have implanted our first complete concentric collapse patient or CCC patients during the quarter after receiving an expansive indication, based on the positive response, we have received from physicians both during and after world sleep, we expect increasing numbers of CCC patients implants in the coming quarters. Taking all of these data points together, we remain confident that we can achieve market leadership status in Germany by the end of '22. Next to Germany, we also made meaningful progress in other key European markets. Based on our existing DOG code in Switzerland, we secured additional critical ready for their first commercial implant to be expected during Q2, and are progressing with reimbursement discussions in the Netherlands, Belgium and Finland.

We have initiated discussions in the UK and we continue to assess opportunities in France and the northern countries. While we are not providing revenue guidance of 2022, we are extremely pleased with our first quarter performance and expect to see revenue totals ramping up further each quarter this year. Let me now talk a little bit more about the DREAM Pivotal study in the U.S. For those who are new, the DREAM trial is of pivotal IDE study in the US.

Let me first walk you through our process on patient enrollment and the funnel that leads from initial enrollment, all the way to implantation. As of today, we have enrolled 503 patients of whom 66 made it through the funnel to implantation. Another 20 have passed their baseline PSG and are awaiting implantation. There are an additional 86 patients in active screening, and we accept that 60% to 70% of these will make it to implantation.

As a result, we believe we have enough patients enrolled to complete the study. Our priority now is to move these patients to the last step of the process in a timely manner, we, therefore, expect to further accelerate of pace of implant. For reference in the weeks, since our last earning call, we have averaged approximately four implants per week. But we have seen that the rate accelerated over the last two weeks to six implants per week, based on all the backlogs having been largely clear, recently open centers increasing the rate of implants and adding private sleep labs, which have excess capacity.

We remain confident that the implant pace will remain at this level and might even accelerate further and that we will achieve our target of implant completion by the end of this quarter. For those of you who saw this in our earning call, I'm pleased to know that based on new and favorable data from the BETTER SLEEP study, the FDA has approved our request to reduce the DREAM study sample size. We are, therefore, now required to implant 115 patients versus the original 134. Aside from the updated sample size, all other study parameters including performance goals, statistical power and significant level remain identical to the original approved study.

The implication for us is that 19 fewer patients need to be implanted, which further strengthens our confidence in closing implants by the end of June. As for CCC, we continue our dialogue with FDA regarding of IDE submission for ACCCESS, the ACCCESS trial, and we still expect to implant the first patient before the end of the year. As part of the breakthrough device designation process, we had our initial sprint discussion with FDA, and we are now incorporating their feedback in our IDE submission preparation. We will provide more details about sample size, design, endpoint and timeline once we secure IDE approval, which we anticipate occurring this summer.

I'm also extremely pleased to announce that we have nominated two outstanding individuals for appointment to our board of directors, pending approval at our Annual Shareholder Meeting on June 8. They are Raymond Cohen, chief executive officer of Axonics who has extensive expertise in developing and executing commercial strategies in medical device, and Ms. Virginia Kirby, executive-in-residence at the Discovery Launchpad at the University of Minnesota's Office of Technology Commercialization, who brings a wealth of clinical and regulatory experience in sleep disorders. With that, I'm pleased to turn the call over to our CFO, Loic Moreau, who will provide a financial update.

Loic Moreau -- Chief Financial Officer

Thank you, Olivier. Good day to everyone and thank you for joining us today. Revenue for the first quarter ended March 31, 2022, was EUR 660,000 compared to EUR 185,000 for the first quarter of 2021. The increase in revenue was attributable to the company's commercialization of the general system in Germany.

Total cost of goods sold for the first quarter 2022 was EUR 289,000 with gross profit of EUR 371,000, representing a gross margin of 56.2%. Our gross margin declined from 64% last year as a result of a one-off incident in our manufacturing site in Tel Aviv in February, which has since been remediated. We expect gross margin to rebound in Q2 and to expand over time, in line with other neurostimulation companies, as we achieve better commercial scale. Overall, Q1 spend accelerated in line with our plan driven by research and development and clinical expenses, R&D increased to EUR 3.3 million in the first quarter 2022 from EUR 3.1 million in Q1 2021 to support our R&D activities, mostly the development of the next generation of our general system, as well as the advancement of our DREAM clinical study in the U.S.

Selling general and administrative expenses rose to EUR 4.2 million for the first quarter of 2022 from EUR 2.4 million in the year ago quarter due primarily to increase commercial efforts in Germany and other European markets. We have also scaled up our cooperating infrastructure and expect to continue adding headcounts to further strengthen our organization. Total operating loss for the first quarter of 2022 was EUR 7.3 million versus EUR 5.3 million in the first quarter of 2021, driven by the acceleration of our R&D spending, as well as commercial and clinical activities. We realized a net loss of EUR 6.7 million for the quarter ended March 31, 2022.

At the end of the first quarter '22, cash and financial assets totaled EUR 127.8 million compared to EUR 135.5 million at the end of December 2021. This represents a monthly cash burn of around EUR 2.6 million for this first quarter. We expect this burn to increase slightly as the year progresses with the advancements of clinical trials, notably DREAM and ACCCESS. We continue to have ample liquidity to get to U.S.

commercialization in 2024. With that, I will turn the call back to Olivier.

Olivier Taelman -- Chief Executive Officer

Thank you, Loic. In closing, I remain very excited about the progress we have made and how well-positioned we are for the rest of 2022. To reiterate, our three key focus areas for Nyxoah this year, they are: First, completing the DREAM implant. Second, accelerating commercial execution in Germany.

And third, commencing our CCC IDE trial in the U.S. before the end of 2022. As we have discussed on this call, we are executing on all of these key objectives and expect continued progress. This concludes the formal order of our presentation.

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

Questions & Answers:

Operator

[Operator instructions] Your first question comes from the line of Jon Block from Stifel. Your line is open. Please ask your question.

Jon Block -- Stifel Financial Corp. -- Analyst

Thanks, guys. Good afternoon and nice quarter, nice update. Olivier, I'll start in Germany, you mentioned the 15 sites expect another 10 by the end of the third quarter. And maybe Olivier, if you could compare and contrast the early centers that you signed up versus the more recent ones, essentially the share of those early centers, and then the onboarding time of the newer centers.

Are you seeing that accelerators that quicker due to the call it the expanded label around CCC?

Olivier Taelman -- Chief Executive Officer

Hello, Jonathan, and thank you for the question. Coming back, it's clear that we see with the early sites that they went to the surgical learning curve, that they also are performing more implants compared to new sites we just started. However, I do have to agree with you that since world sleep in Rome and the communication of BETTER SLEEP data, that we are seeing also an acceleration in the early sites by having the opportunity to also implant CCC patients because just as a reminder, they don't need to do a dice procedure anymore to exclude CCC, to be implanted and yes, we do see that this is really working in our favor.

Jon Block -- Stifel Financial Corp. -- Analyst

Got it. Fair enough. I'll maybe ask one or two more. I'll flop over to the financials, the gross margins that you laid out.

I know you mentioned there was a 1Q '22 incident around February, just to be clear, I think you said down in 2Q, so to be clear, is that down sequentially or down year-over-year. And then, maybe the timing of the ramp back up, in other words, is it a situation where it's a pretty quick situation to rectify and exiting '22? We could already be above what we saw in the late '21 level of low 60s and then I'll just ask my final question after that.

Loic Moreau -- Chief Financial Officer

Yes, thank you. As I said, we experienced a one-off incident with Tel Aviv manufacturing site, this caused a slight description during the quarter, and this is a reason for the gross margin. This has been fixed and remediated so we expect a rebound already in Q2 and we expect to end the year above the level of 2021. I can also confirm.

Jon Block -- Stifel Financial Corp. -- Analyst

All right.

Loic Moreau -- Chief Financial Officer

Yes, I can also confirm that we have a sufficient inventory to meet our demand, at least for the second and the third quarters of 2022, as we have now two manufacturing sites, the one in Tel Aviv and another one in Belgium to ensure continuity of supply. We have the continuity of supply and you will see a rebound already in Q2, and we expect to end the year at a level, which is higher than 2021 mainly driven by a higher volume than 2021.

Jon Block -- Stifel Financial Corp. -- Analyst

OK. Got it. Thanks for that clarity. Maybe I misheard you.

And then, the last one, Olivier is just sort of a big picture on DREAM, it's been a heavy lift, you've made a lot of progress. You mentioned the 66 patients actually implanted another 20 pass in the baseline and then 86 in additional active screening, 60% to 70% of those make it to the implantation. My point is, you're knocking on the door, if you do that math, of 134, and that's a pretty quick process in terms of getting those inactive screening through, why change it right now? And I get it, the statistical significance supposedly isn't altered, but you're so close. I'm guessing it was 134 for a reason and not 115.

It seems like if you're going to get to that 134 number based on the funnel you laid out, why not just leave it alone considering the importance, obviously, and the scale of the trial and make little tweets here when it seems like with all due respect, you're sort of in the eighth inning of getting across the goal line. Thanks for your time, guys.

Olivier Taelman -- Chief Executive Officer

Thank you for this last question, Jon, because in fact, it is a question where we also internally discussed around. To your point, if you look at our funnel and the number of patients enrolled, we should be able to make the 134 implants by the end of June. So that is clearly correct. Now, when we initially designed DREAM, it was clear based on our interaction with FDA, that the expectation was to closely mimic Inspire's STAR trial that led us to the sample size of 134.

Now, based on the strong BETTER SLEEP learnings and also understanding a little bit more on a co-primary endpoint of ODI, we went back to FDA and they approved that we could increase the ODI responder rate assumption really slightly without changing statistical powering or efficacy endpoints, as compared to the original study design. To say, it's a really crystal clear, originally, we have to show an NHI respond rate of 65% and now also after going back and slightly increasing ODI also to 65%, that is what was impacting the sample size reduction of 19 subjects that we have to implant last. And finally, Jon, why not take the 115, even increasing of confidence, also giving us the opportunity to leverage on our current resources, to do a very high quality study follow up and I'm not taking this opportunity. I think and I hope you will convey that if that could be possible without changing anything that everyone would make the same choice.

Jon Block -- Stifel Financial Corp. -- Analyst

Yeah. Understood. Thanks for the coverage.

Operator

Your next question comes from the line of Suraj Kalia from Oppenheimer. Your line is open. Please ask your question.

Suraj Kalia -- Oppenheimer and Company -- Analyst

Hey, everyone. Olivier, can you hear me all right?

Olivier Taelman -- Chief Executive Officer

Yes. Yes, I can, Suraj.

Suraj Kalia -- Oppenheimer and Company -- Analyst

Perfect. Olivier, just wanted to piggyback on Jonathan's last question, OK? So the sample size in DREAM has been reduced, right? It is an unblinded trial. So what is the clinical significance of the 65%  in ODI that has been changed? I'm just trying to get my arms around how that -- you had a certain event rate assumption in your novel hypothesis and the ODI component has been changed. So maybe just kind of walk us through the clinical significance and what specifically are you seeing given that it's unblinded that you all went to the FDA and requested the small data?

Olivier Taelman -- Chief Executive Officer

First, Suraj, thank you for the question. First, I would like to point out that when we went back to FDA, this was based on BETTER SLEEP data. So there was no data that we are making available or that we are using in order to communicate with FDA. I think this is really important to make this point, first of all.

Next, when we look at the DREAM, we had co-primary endpoint of AHI with a response showing 50% reduction with an AHI below 20, the so-called Sher criteria. For ODI, we had respond showing 25% reduction. Now, by slightly increasing the ODI respond rate assumption, 65, the total sample size was reduced from 134 to 115. Now, what made us confident in doing this, if you look at BLAST OSA published data, you see an ODI respond rate of 70-plus percent.

If you look at the STAR trial for inspires, you see an ODI respond rate of 70-plus percent. And in BETTER SLEEP, we are seeing comparable numbers. That is in fact what really triggered us to say, OK, let's go back, let's take and increase slightly this respond rate with 1% and gain from the positive impact in having to do less patients, which, of course, further derisks the DREAM trial in closing the enrollment in a timely manner.

Suraj Kalia -- Oppenheimer and Company -- Analyst

Got it. Fair enough. Olivier, in terms of follow-up on DREAM, the enrollment, you talked about picking up from four to six in the US. Are there any concentration, site-specific concentration of enrollment? Or would you say it is a relatively broad-based, at least in DREAM, at this stage?

Olivier Taelman -- Chief Executive Officer

No. So what we are seeing is, and I think you can see this in several other of studies, you have sites who are enrolling faster and who are enrolling more patients than initially we would have predicted. The distribution curve of enrollment to say it like this, it's not equally scattered, there is a difference. I'm just looking Suraj, just to point out some of the strong sites I can already take, for example, Cornell.

I have to point out Vanderbilt University. I have -- I can point out, the University of Iowa. And I also can point out the last one and let me quickly have a look on this one, Dr. Melissa Hancock in Boca Raton in Florida, just to name a few, who are really sticking out.

The other ones, they are going as planned.

Suraj Kalia -- Oppenheimer and Company -- Analyst

Got it. Final one, Olivier, and hop back in the queue, in Germany, I know you all talked about the sites. Maybe if I could just drill down a layer deeper, what is the average time per procedure that is being recorded, Virginia? How is the competitive matrix decision being made or the choice being made for uni versus bilateral? Is it just CCC? Is it lack of dice? Are there other criteria that -- can you just kind of walk us through, Suraj comes into, I don't know, the hospital, right, how does the doc eventually choose either Inspire or Nyxoah? That would be greatly appreciated, and congrats again.

Olivier Taelman -- Chief Executive Officer

Thank you. So Suraj, in all openness, what we see is that there is a surgical learning curve. So in the first let's say three to four implants, we see that the average implant time skin to skin, it's a little bit above one over, so more the range of one over 20. And once the surgeon is going to fourth, fifth, sixth implant, we see this being reduced to 60 minutes.

We even have one patient that was implanted in 51 minutes. That is to answer the question on skin-to-skin surgical time. I think we can summarize it around 60 minutes on average, once the surgeons have passed their surgical learning curve. That's what we are seeing in several accounts coming from several surgeons in Germany.

When it comes to choosing Nyxoah over Inspire based on surgical learning curve, I think that is one component. Another very important component is the fact that we are the only technology with the single-incision procedures. This is what we are hearing back a lot from patients and from surgeon that this is really driving and explaining why they would choose from Nyxoah and then last also the fact that we have a scalable technology platform where we can push through software upgrades where patients do not need to come back when the battery is depleted. That is also clearly helping in making the choice of having a Nyxoah implant compared to an Inspire implant.

Finally, and I'm always saying this, and I would like to repeat it as well. The market is so large that I think by just having a second company, and that's what we hear from a lot of surgeons that having this option to choose will only accelerate penetration overall for hypoglycemic stimulation. I hope this is answering your question.

Suraj Kalia -- Oppenheimer and Company -- Analyst

Thank you.

Operator

Your next question comes from the line of Ross Osborn from Cantor Fitzgerald.Your line is open. Please ask your question.

Ross Osborn -- Cantor Fitzgerald -- Analyst

Hi. Thanks for taking our question and congrats on the quarter and all the progress. Maybe just starting off with a couple on your operating expenses, would you be able to just provide some additional color on your commercialization apps first that are driving up the step up and SG&A expenses? And then as a follow-up, are there any quantitative results you can share at this point from your digital marketing work in Germany?

Loic Moreau -- Chief Financial Officer

Yes, so I will take the evolution of SG&A expenses and commercial. The increase you see in Q1 2022 is mainly related to our team in Germany. We have now a team in place in Germany sales, marketing and digital marketing as well, which we did not have in Q1 last year. You see a ramp-up in term, of course, associated with the team that is now fully in place.

As you pointed out rightly, we are starting a number of digital marketing campaigns. And Olivier will make a couple of comments on what we can already share in term of output of this campaign.

Olivier Taelman -- Chief Executive Officer

Thank you, Loic Moreau. Coming back to direct to patient campaign, it's clear that we have increased our presence on Instagram, Facebook, and on these different accounts. What we saw so far is already a three-time increase of the number of visits, we offer building it up during Q2. And we expect to be able to report also very complete hits and measurement in our next opening call, but it's clear that we launch it in Q1, we see a triple increase of our visits already and we see it growing effect day by day.

Ross Osborn -- Cantor Fitzgerald -- Analyst

OK. Great. I'm glad to hear that. Then maybe just one more for me and bigger picture question.

Is there anything you could share from the Vanderbilt collaboration at this point?

Olivier Taelman -- Chief Executive Officer

Besides the fact that we are working off together with Vanderbilt and in getting through the first prototypes putting them in place and also further debating and discussing on how we could add the technology of empathic stimulation and make this increase the response rate. Or the overall responder rate for patients suffering from obstructed sleep apnea that is where, where we are currently working on so to be very complete, what you can expect this year is a prototype, the first studies with studies with animals and further discussions on the positioning of the product next to potential novel stimulation.

Ross Osborn -- Cantor Fitzgerald -- Analyst

OK. Sounds great. Thank you.

Operator

Your next question comes from the line of Adam Maeder from Piper Sandler.Your line is open. Please ask your question.

Adam Maeder -- Piper Sandler -- Analyst

Hi. Good morning. Thanks for taking the questions and congrats on the Q1 result and nice start to the year. Maybe just to start on CCC.

It sounds like you've done some commercial implants there, would just love to get a little bit better of a sense for the number of implants that you've done in the CCC patient cohort, commercially. How have those cases gone? What's the feedback, and then how quickly should we expect this part of the marketplace to ramp, and then I'd add one follow-up? Thanks.

Olivier Taelman -- Chief Executive Officer

Yes. Well, thank you, Adam for this question, so when it comes to CCC implants, so we did our first implants in Germany, and I have to admit it was still modest. The reason why the number was modest and now we are talking about three patients that we have implanted, was driven by the fact that it took some time before everything was ready in our IFU. And also we see that there are physicians that were waiting very simple to hear back from the beta sleep data that we only communicated during the world sleep in Rome.

That's why it took maybe a little bit longer than initially expected. But the first three cases, what I can report on is that the cases and the procedures were very successful just for you reference, those were exactly identical procedures then to non-CCC patients just to avoid any confusion. So they went very successful and the surgeons were enthusiastic about having no surgical solution to also offer to their CCC patients. Now, as you also know, it'll take approximately two months post-surgery before we switch on the device, and we are slowly getting to that point of switching on.

In the next revenue call, I can also give you further update on the response of those first two, three patients in their AHI reduction. But so far so good. Procedure went well, surgeon happy, patient happy, no complications. That is what I can update you on.

Now, going forward and to answer the question is, as you know in literature, we are talking about roughly 30% of the entire moderate to severe OFA patient population that would suffer from complete concentric collapse so in our expectations, and that is also where we are working on and going forward, we expect to see a comparable number increase coming from CCC in going forward.

Adam Maeder -- Piper Sandler -- Analyst

Great. Thanks, Olivier. That's very helpful. Then just quickly on the follow-up, I'll ask one on just the top line.

I know you don't have financial guidance, but it certainly sounds like you expect quarterly sequential improvement throughout each quarter of this year. I also think I heard you make a comment that volumes accelerated significantly throughout Q1. So I'm wondering if you can put a finer point just on kind of intra-quarter trends or the exit rate in Q1 or just whatever puts and takes you can give us here, as we think about our models for the remainder of the year would be helpful. Thanks so much.

Olivier Taelman -- Chief Executive Officer

Adam, you are asking the challenging questions, and then you know that we are not providing guidance, so you will not hear it from me, but maybe you have more chance with Loic. Loic Moreau, how do you want to comment on this?

Loic Moreau -- Chief Financial Officer

On the sales, we are obviously very encouraged by the positive feedback and the momentum we are seeing in Q1. We do expect to see revenue increase every quarter this year and to continue this momentum that's clear even if we don't give formal guidance, what we can say is we are generally comfortable with current analyst consensus for 2022.

Adam Maeder -- Piper Sandler -- Analyst

OK. That's great. Really appreciate the color and congrats again.

Operator

Your next question comes from the line of Michael Polark from Wolfe Research. Your line is open. Please ask your question.

Michael Polark -- Wolfe Research -- Analyst

Hey. Good morning. Good afternoon. On the rest of 2022, is it fair to say it's still a Germany story from a revenue perspective, or do you expect some of these other European countries to contribute more meaningfully?

Olivier Taelman -- Chief Executive Officer

It'll stay a German story in the sense that we want to do a commercial proof of concept in the largest market outside of the US where competition is present, but next to this, you can also expect a strong acceleration from the countries like Switzerland, where we already have the DOG, then there is Spain. Of course, we expect also to start generating our first revenue in the Northern countries and we are hoping that we can also get a positive reply on our reimbursement files in the Netherland and in Belgium.

Michael Polark -- Wolfe Research -- Analyst

If I can ask one follow-up on the ACCCESS study in the US, can you remind us I believe it's expected to be smaller than DREAM. Do you have a better sense of what the sample or target sample will be at this stage and general expectations for timing, if you implant your first patient by the end of this calendar year, is that a project that could fully implant in 12 months or would you potentially need a little longer than that? Thanks so much for taking the questions.

Olivier Taelman -- Chief Executive Officer

Thank you, Mike, for asking this. When we look at CCC without jump into any conclusions, but in our discussions with FDA, we think that it's realistic to aim for a sample size of 90 to maximum 100 patients. That's where we expect to end up with but once again, it needs to be approved. Now, answering the second part of your question saying, how fast can you implant? There, of course, we have a great advantage coming out of the dream study that we know have identified in the US and not only identified, but also trained surgeon who can do implants.

We already are actively forming the surgeon that want the CCC study or the ACCCESS study will be approved, that they can participate. The patients that today they cannot offer hypoglossal nerve stimulation solution because they have CCC, they are lined up in these sites. So I think it is realistic to expect that once we do the first patient, that in 12 months, or maybe even less than 12 months, we will finish also the complete ACCCESS patient enrollment.

Operator

There are no further question at this time. I would like to turn the over to the CEO Mr. Olivier Taelman.

Olivier Taelman -- Chief Executive Officer

I would like to thank everyone for joining and attending this call. I hope you share the same excitement as we do at Nyxoah with our strong Q1 result and we will be working extremely hard, continue this ramping up, continue showing the results, and you will hear back from us during our Q2 earning call. Thank you for attending and have a very nice day. Bye bye

Operator

[Operator signoff]

Duration: 40 minutes

Call participants:

Jeremy Feffer -- Investor Relations

Olivier Taelman -- Chief Executive Officer

Loic Moreau -- Chief Financial Officer

Jon Block -- Stifel Financial Corp. -- Analyst

Suraj Kalia -- Oppenheimer and Company -- Analyst

Ross Osborn -- Cantor Fitzgerald -- Analyst

Adam Maeder -- Piper Sandler -- Analyst

Michael Polark -- Wolfe Research -- Analyst

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