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Operator
Good day, and thank you for standing by. Welcome to the Nyxoah Third Quarter 2022 Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded.
I would now like to hand the conference over to your speaker today, Jeremy Feffer, Vice President, Investor Relations. Please go ahead.
Jeremy Feffer - VP of IR & Corporate Communication
Thank you, Michelle. Good afternoon, and good evening, everyone, and welcome to our earnings call for the third quarter of 2022. Participating from the company today 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 third quarter financial results released after U.S. markets 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. And this call is being recorded and will be archived in the Events 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 SEC on March 24, 2022.
With that, I will now turn the call over to Olivier.
Olivier Taelman - CEO & Executive Director
Thank you, Jeremy. Good afternoon, and good evening, everyone, and thank you for joining us for our third quarter 2022 earnings call. As an overview of the third quarter, I'm happy to report that we are on the verge of closing implants in our U.S. pivotal study, DREAM. And we remain on track to have 12-month clinical data in fall 2023.
We have also commenced our U.S. ACCCESS trial for complete concentric collapse or CCC patients with first implants expected before year-end. Commercially, demand for Genio in Germany remains robust, and we keep showing growth in opening new sites. This reconfirms our confidence exiting 2022 as market leaders in Germany.
Let's first begin with a fact-based summary of our Q3 achievements. To date, we have implanted 110 patients in our DREAM trial with the remainder to be completed in the coming weeks. This will start the clock to generating 12 months efficacy data next fall. From a regulatory perspective, we plan to submit the first 3 modules of our modular PMA prior to having clinical data next fall. We reiterate our time line of regulatory approval in the second quarter of 2024.
We have begun activating sites in our U.S. ACCCESS pivotal study focused on complete concentric collapse patients and continue to expect initial implants before year-end. 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 U.S. and who currently have no suitable treatment option other than major palate surgery.
Commercially, in Germany, demand for Genio remains high. We activated 6 new commercial sites in Germany during the third quarter, bringing our total to 32 active sites. We expect a very strong fourth quarter with up to 40 active sites by year-end. That said, we were supply-constrained due to a temporary issue at one of our component providers, which I will detail shortly, that resulted in us postponing availability of inventory in Germany.
The U.S. DREAM trial was never impacted by this inventory constraint. As a result, we reported sales of EUR182,000, well below underlying demand. This is not reflective of the progress our commercial team has made as we received additional purchase orders of roughly EUR700,000 that remained open at quarter end. Importantly, the supply issue has been remediated and the vast majority of the orders that were open have since been felt.
Notably, this supply constraint with combined third quarter open orders and reported sales, we estimate that our share remains consistent with the second quarter. What makes me even happier is to see the demand in Q4 remains high. This strengthens our confidence to be the market leaders exiting 2022 in Germany.
Now let me start with a review of our first priority, an update of our 2 pivotal IDE studies in the U.S., DREAM and ACCCESS. In the DREAM study, to date, we have completed 110 of the 115 implants with the remaining 5 implants scheduled for the next few weeks. We remain on track, having 12-month clinical data from the study in the fall of 2023 with regulatory approval expected in the second quarter of 2024.
As discussed previously, we are pursuing a modular PMA process. We are preparing the first module and anticipate submitting it in early 2023. In the meantime, we have already begun investing in our U.S. market access organization to ensure reimbursement upon approval. As for our ACCCESS study for complete concentric collapse patients, we are now activating clinical sites. As a reminder, we plan to implant up to 106 patients across up to 40 clinical sites in the U.S.
These CCC patients who represent 30% of the eligible to treat hypoglossal nerve stimulation OSA population or currently contraindicated for hypoglossal nerve stimulation in the U.S., and therefore, their only treatment option after failing CPAP is currently major palate surgery. With the CCC label, not only will these CCC patients be eligible for hypoglossal nerve stimulation therapy, but all Genio patients will no longer have to undergo a Drug-Induced Sleep Endoscopy or DISE since determining CCC will no longer be a prerequisite to getting an implant.
In Europe, we -- where we already obtained a CCC indication, physicians and patients are already benefiting for no need for the DISE procedure. This is a true demonstration of our patient-first approach to OSA therapy, not only are we providing a much less invasive treatment option for CCC patients, but we're also streamlining the path to hypoglossal nerve stimulation therapy for all Genio patients by eliminating the need for the DISE or any procedures to diagnose CCC.
We still anticipate initial implants before year-end, and we expect to complete all 106 implants in ACCCESS within a year for the following reasons. First, we already have a database of patients who screened out of DREAM because DISE showed they have CCC. Second, we will have more opportunities to enroll patients since we will activate up to 40 sites versus 20 sites for DREAM. Third, there are no hypoglossal nerve stimulation alternatives for CCC patients, so there will be no competition for these cases.
Fourth, home sleep test will be used to qualify patients. And we have learned a great deal from DREAM in how to more efficiently move patients through the funnel from enrollment all the way to implant. We continue to expect regulatory approval in the first half of 2025. So roughly 1 year after the non-CCC approval that we expect coming from DREAM.
Importantly, we are generating growing interest and enthusiasm within the clinical community as we move closer to U.S. commercialization. This was evidenced by more than 90 ENT surgeons and sleep physicians who attended our symposium at the AAO-HNS Conference in Philadelphia in September. Nyxoah's patient-centric approach, which includes full-body MRI compatibility, a leadless system, bilateral stimulation posed by a non-implantable pulse generator, a scalable platform is resonating very well with the U.S. clinical community. I would like to thank the entire Nyxoah team for their great work and focus on execution as we continue to advance the Nyxoah study.
Moving on to the second priority. Our European commercial launch focused primarily in Germany. Germany is the largest and most competitive hypoglossal nerve stimulation market outside of the United States. Nyxoah has a dedicated German sales and marketing team of 15 people and a similar DRG and reimbursement level at the same price point as other hypoglossal nerve stimulation technologies. We have defined our commercial success by becoming market leaders by the end of 2022.
As I mentioned earlier, during the third quarter, we experienced a temporary supply disruption in Europe as one of our component suppliers had a malfunctioning machine. This has been solved. To further optimize our supply chain this quarter, we are bolstering our Israeli manufacturing capacity with a second site in Belgium and have sufficient capacity to meet demand. Additionally, we are in the process of adding a third production line in the U.S. with a well-known contract manufacturer.
That said, during the third quarter, we postponed availability of commercial inventory in Germany and therefore, report sales of EUR182,000. Underlying demand, however, remains very strong with about EUR700,000 of confirmed purchase orders being deferred to the fourth quarter. While I do not plan on providing any fourth quarter guidance, since we never provided any guidance, I think it is important to show that our third quarter supply issue has not dampened demand for Genio.
We continue to hear from physicians that because of our label expansion to include patients with complete concentric collapse, they are increasingly opting for Genio as they do not have to perform a Drug-Induced Sleep Endoscopy or DISE procedure. This drastically shortens the time between diagnosis and implant and removes the burden for both patients and physicians, thus positively impacting access to Genio for patients who are in desperate need of a suitable solution for their OSA.
We also launched the program called Care4 in Germany. Care4 will use the AcuPebble home sleep test to accelerate the pathway to the Genio solution. AcuPebble will be used to confirm a prior PSG for existing CPAP patients, thus enabling them to receive an [HGNS] implant without waiting up to 6 months for the confirmatory PSG.
To this end, we are hosting an event around the German National Sleep Society Annual Conference in Wiesbaden tomorrow, entitled Obstructive Sleep Apnea from Diagnosis to Treatment. This event will be webcast and information on how to access, it is present on our website. Looking at markets outside of Germany this quarter, we commercially implanted patients in Switzerland, where we have a full reimbursement, including DRG in place. We continue to establish our position as an innovation leader in the OSA space, always putting patients and clinicians first in our [OMB] strategy.
As we have discussed previously, we received regulatory approvals for Genio 2.1 next-generation system, which improves patient comfort and compliance without the need for a surgical procedure to replace the implantable component. Genio remains the only scalable hypoglossal nerve stimulation implant, which allows patients to always have the most advanced features with their existing implant and therefore, not have to undergo another surgery.
We are also developing future generation of both the implantable stimulators and the Activation Chip to improve the patient experience. For the implantable stimulators, we are working on an implant for life. As for the Activation Chip, its design will become more economic and integrate patients' and physicians' feedback. We will provide further updates on these developments as they process.
Now updating you on the Vanderbilt, Nyxoah Ansa Cervicalis collaboration project, we are processing towards a prototype device and expect to commence a feasibility study in 2023. These efforts embody our mission to build a product pipeline that will enable us to expand the market by offering solutions to current non-responding hypoglossal nerve stimulation patients and non-eligible moderate-to-severe OSA patients. We look forward to providing periodic updates.
With that, I'm pleased to turn the call over to our CFO, Loic Moreau, who will provide a financial update.
Loic Moreau - CFO
Thank you, Olivier. Good day, and good evening to everyone, and thank you for joining us today. Revenue for the third quarter ended September 30, 2022 was EUR182,000. As Olivier already mentioned, third quarter revenue was impacted by a temporary supply disruption that limited our ability to meet demand in the quarter. The issue has been remediated and we have filled the vast majority of the open orders with no cancellations.
Total cost of goods sold for the third quarter of 2022 was EUR63,000, implying a gross margin of 65.3%. As a reminder, we continue to expect gross margin to expand over time in line with other neurostimulation companies as we achieve greater commercial scale. Total third quarter operating expenses were in line with our plan as we continue to focus on research and development and clinical programs.
R&D increased to EUR4.2 million in the third quarter of 2022 from EUR3.5 million in the third quarter 2021, mostly due to the development of future generations of Genio. Selling, general and administrative expenses rose to EUR4.8 million for the third quarter of 2022 from EUR4.5 million in the year ago quarter due primarily to increased commercial efforts in Germany and other European markets. We also added headcount to our corporate infrastructure and expect to continue investing in human capital as we further scale up our organization, particularly our U.S. commercial team.
Total operating loss for the third quarter of 2022 was EUR8.8 million versus EUR8.1 million in the third quarter of 2021, driven by the delay in the third quarter revenue, the acceleration in our R&D spending and our commercial and clinical activities. As of September 30, 2022, cash and financial assets totaled EUR115.4 million compared to EUR135.5 million on December 31, 2021.
Monthly total cash burn was around EUR3 million during the third quarter, which benefited from foreign exchange tailwinds. We continue to expect monthly cash burn to increase slightly going forward as we commence the ACCCESS trial in the U.S. and invest in our direct-to-patient marketing efforts in Germany.
With that, I will turn the call back to Olivier.
Olivier Taelman - CEO & Executive Director
Thank you, Loic. I'm extremely proud of how the team responded to the challenges we faced during the third quarter and how strongly we are executing coming out of it. As a result, we are not changing any of our expectations on our key strategic objectives, being having DREAM 12-month clinical data available in the fall of 2023, resulting in regulatory approval before 2024 (technical difficulty) ACCCESS patients this quarter and achieving German leadership by the end of the year.
This concludes the formal part of our presentation. Operator, I will turn the call over to you to begin our Q&A session.
Operator
(Operator Instructions) Our first question -- our first question comes from Adam Maeder with Piper Sandler.
Simran Kaur - Research Analyst
This is Simran on for Adam. I want to start off on the supply chain disruption that occurred during the quarter. So when exactly did that occur? And it does sound like you guys have taken the step to kind of mitigate or prevent that from occurring. So when can we -- what should we be expecting in terms of the second source supplier that you found, and it sounds like additional manufacturing capacity? So I guess, what should we be expecting from a capacity perspective going forward?
And then to follow on there, even if we back in the unfulfilled orders that still puts Q3 revenue shy of the Street by about EUR500,000 or so. So can you elaborate on the commercial trends in the quarter? Maybe just talk about some of the headwinds that you're seeing in the field or in the commercial organization and then progression month-to-month, that would be great as well?
Olivier Taelman - CEO & Executive Director
Thank you for all these questions. So let me start by answering. Of course, it's very inconvenient when you're facing something that we went through. To answer your question, we saw this, it was picked up end of August that there was an issue with one of our sub-suppliers. I think with a fast-growing company, those kind of bumps in the road can happen.
And I think more important is also how the team shows resilience -- of their resilience in solving this. So therefore, I can confirm the moment we saw this, I think the positive thing is that our quality system, our quality system immediately picked it up. Next, we solve the issue, and then we start rebuilding and making sure that we are able to have a significant supply. That is one thing.
On top of this, and this is not new, but I would like to actually emphasize on this. Next to our Israeli manufacturing plant, we also now have the Belgium manufacturing site that passed successfully their audit. So that will definitely increase and make sure that we have sufficient manufacturing capacity to meet our clinical and commercial demands and to build stock in going forward.
And I hope that this is, in fact, answering the first part of the question. Now the next part that I'm hearing is where you are saying, what about your German revenue expectation for the [third] quarter. So yes, in total, we see that we have [900 scale demand], and that is showing that our market share was consistent with the market share we reported in the second quarter despite the procedure deferrals to the fourth quarter. So that's one thing.
When it comes to the Street expectation, so we never gave any guidance, and we are still not doing this. But what I can say is that we still feel very confident that we will have a strong Q4 quarter that on top of this, we were able also to have the backlog orders filled that we saw during quarter 3. And therefore, that we can exit 2022 more or less in line with the expectations of the analyst consensus.
Without giving true guidance, I think I'm answering quite a lot. So we expect 2022 to be in line with the analyst consensus, a strong Q4, we fixed our issue, and we're also backfilling the shortage that we had and the POs that we had that were standing open in quarter 3.
Simran Kaur - Research Analyst
Okay. Okay. Perfect. So just to maybe put a finer point on your comments there. I think I'm seeing consensus revenue about EUR2 million in Q4 prior to this call. So it sounds like that should still hold and does also take into account this onetime kind of bolus of unfulfilled orders that we should be expecting to see in Q4. Is that the right way to think about it?
Olivier Taelman - CEO & Executive Director
Yes. So we want to keep our Q4 being very strong. We want to pick up the loss that we had in quarter 3. And since you are talking specific numbers, the Street consensus for 2022 is EUR5 million, and there, we are still feeling very confident that this is within reach.
Simran Kaur - Research Analyst
Okay. Okay. Perfect. And then I guess another question that I had was we understand there was a change to the guidelines in Germany regarding the role of oral appliances and where that fits into the care continuum (technical difficulty) specifics between CPAP and hypoglossal nerve stimulation. Is that correct? And can you level set us there with more details? Like have you seen an impact to your business and how could you navigate this dynamic going forward?
Olivier Taelman - CEO & Executive Director
In all honesty, we have not seen any impact of this to our business. So that is I -- what I can comment. I know it's a very short comment, but we did not see any impact at all to our business from this.
Simran Kaur - Research Analyst
Okay. Okay. Perfect. I guess if I could squeeze one last one in here just on DREAM.
Olivier Taelman - CEO & Executive Director
Yes.
Simran Kaur - Research Analyst
As I think about the time lines, if you expect to finish implanting all the patients in, I think you said the coming weeks, a 12-month follow-up would put you in the late November, kind of December time frame. So that does sound more like a late 2024 event in terms of when you would finish all of kind of the clinical data work. So Q2 2024 regulatory approval, that does seem a bit tight. So maybe just walk us through that timing and your confidence to reaffirm the time lines here?
Olivier Taelman - CEO & Executive Director
So, first of all, we expect indeed 12-month data in fall 2023, so end of November. As you know, this is an open-label study, so we are able to track to monitor and to analyze data in real time. So therefore, we will have the full data set very soon after the final patient implanted reaches 12 months. That's one thing.
And on top of this, we talked about a modular PMA, where the first 3 modules already be submitted and should be also approved. So that by the time we reach November or end of November, we only need to add the efficacy module to this. And then we think that it's really realistic to have 6 months to 7 months after that, getting a regulatory approval by FDA, and that brings us to the time line where I was saying, by the end of quarter 2 in 2024, we are expecting regulatory approval.
Simran Kaur - Research Analyst
Okay. Perfect.
Olivier Taelman - CEO & Executive Director
You're welcome.
Operator
Please standby for our next question. Our next question comes from Jon Block with Stifel.
Jonathan David Block - MD & Senior Equity Research Analyst
Great. Maybe just on the first one, Olivier, if the inventory issues did not impact DREAM, which I think you were pretty clear, did not. Can you just talk a little bit about what slowed the enrollment pace or maybe I should say the implantation pace in 3Q? I think on the prior 2Q call in August, you thought that you might be a couple of months away. I think it was maybe 4 weeks to 6 weeks or even 8 weeks, and it looks like it might fall closer to 4 months, give or take. So is there anything to call out in terms of what slowed down at the centers? Again, it doesn't seem to be a supply issue, but market or competitor-wise that has caused really a slight push if you would out by a couple of months to that, right?
Olivier Taelman - CEO & Executive Director
Jon, thank you for this question. And first of all, let me start by confirming that there was never any inventory issue in the U.S. for DREAM study. So that you picked up very well. Now answering your question, over the last few months, we implemented solutions to existing bottlenecks. I'm sure you recall during our last earning calls that we identified 2 major bottlenecks, one was scheduling PSG slots and the other one was finding work plan or dealing with OR capacity.
Now for the PSGs and finding the PSG slots, we addressed the bottleneck by working with private sleep centers, and that seems to work out very well. Now when it comes to finding a work plan, yes, I have to admit there is a competition, there is a competition between us and Inspire because as you just heard, they also had a very positive quarter in quarter 3. We have a lot of overlap with our clinical sites, and we were impacted from an OR capacity perspective.
Now that also putting this in the right perspective, we reached 110 implants, out of the 115. The other 5 of the 5 missing patients, they are identified. We know where they are, and we also know what the OR dates will be and will look like. So we think -- I think we did very well already, 110, out of the 115, 5 identified, and in the coming weeks, they will also be implanted and then the clock can start ticking for 12-month data.
Jonathan David Block - MD & Senior Equity Research Analyst
Okay. Perfect. Very helpful. And maybe just to pivot for the second question. When we think about the eventual U.S. commercialization efforts, is there any change in strategy for you guys if you're #2 to market or number (technical difficulty) here in the U.S., what changes, if anything? And maybe Olivier, what can you do along the way to strengthen your hand, publication of papers, BETTER SLEEP, et cetera. So that when you're there and if you're close to another player, you're sort of all set to go from a commercialization from a papers effort to really hit the ground running?
Olivier Taelman - CEO & Executive Director
So, first of all, based on the info, yes, we are feeling pretty confident that we will be the #2 after Inspire on the market. Let me point this one out. Next, how are we preparing already and how are we preparing our future U.S. strategy. As I mentioned, we already hired an market access director. She is already very intensely working together with payers.
She's reaching out to Medicare. So she's really preparing and laying out already also the discussions on what kind of CPT codings we will be using. So all this work is going on and part of this has already been done at the point where we are today. That is one thing.
Next, over the coming months, we will start further investing in hiring commercial leadership, so that we can start by having those people on board already start looking and building and further preparing our commercial structure will look like and even start reaching out in which sales people we would like to hire, what would be the type of profile that you would like to hire and also where would we identify and where can we find this talent. So that's the second thing that you can expect in 2023.
And for the rest, the only thing that I can comment is that it's sometimes nice to be second because somebody already paves the way in how to enter market, in how to introduce hypoglossal nerve stimulation with payers, and we definitely think we can benefit from this as well. So today, our focus stays on getting the last 5 implants done, having the clock starts ticking, getting regulatory approval somewhere in quarter 2 2024 and then before making sure that we do all the proactive activity needed to build a team already started by market access people and also by investing in hiring of sales leadership.
Jonathan David Block - MD & Senior Equity Research Analyst
Great. Very helpful color.
Operator
Please standby for our next question. Our next question comes from Ross Osborn with Cantor Fitzgerald.
Ross Everett Osborn - Research Analyst
Congrats on the progress. So maybe looking at Switzerland, given it accounted for a significant amount of revenue during the quarter. Are you able to disclose how many active sites you have there now?
Olivier Taelman - CEO & Executive Director
Sorry, active sites in Germany you mean?
Ross Everett Osborn - Research Analyst
In Switzerland, just curious your level of presence there?
Olivier Taelman - CEO & Executive Director
Okay. Okay. Sorry, yes, that was not very clear. So my apologies. So in Germany, we have 32 active sites. And in Switzerland, we had in quarter 3, we had 1 active site that did implants, and we are expecting going forward to add 3 more. So 32 in Germany, 1 in Switzerland. For Q4, we are going up from 1 to 4 in Switzerland and from 32 up to 40 in Germany.
Ross Everett Osborn - Research Analyst
Perfect. And then outside of Switzerland, how are conversations going in Belgium, Italy, Spain?
Olivier Taelman - CEO & Executive Director
Yes. So outside of Switzerland, we have Spain, where we have reimbursement, and we also have Finland, where we have reimbursement. When it comes to French, for example, because you know that we did saw some activity. I can only say that I can only applaud Inspire for the progress of introducing hypoglossal nerve stim in such a difficult market like France.
But I also know that this definitely will help us in building our case in France as well. So that's where we stand for the moment. In Belgium, we also have submitted the reimbursement file, but we do not expect in the coming 18 months to 24 months that we will be present there. And in the Netherlands, also there we have reimbursement activities ongoing, but also there from a planning perspective, we don't expect anything in the coming 18 months.
Operator
Please standby for our next question. Our next question comes from Suraj Kalia with Oppenheimer.
Unidentified Analyst
This is Mike on for Suraj. Curious, picking up on the centers theme, what gave you the confidence to up your German year-end centers guide from over 35 to over 40, was it more de novo or existing centers driving the growth? Any competitive dynamics at play there or just a preference for Genio and bilateral stim?
Olivier Taelman - CEO & Executive Director
Yes. So we saw a lot of momentum in Germany over the last 6 months to 12 months. So while being and increasing our commercial presence, increasing our presence at consensus, we saw that a lot of sites starting approaching us, even sites that we honestly in the beginning was not really aware that they had such a high interest installing with hypoglossal nerve stimulation and more specific solving with Nyxoah with our Genio technology.
So that is the explanation why we are increasing our number of sites. As you know, a total German market, also there the overall penetration is still low. So the more size you have that are enthusiastic that can deliver on high (technical difficulty), I think the more beneficial this also will be in treating more patients and continue showing a strong market growth.
Unidentified Analyst
Excellent. That makes sense, Olivier. And then I know you mentioned the German share was flat sequentially with the 28%, I believe in 2Q. Do you have any targets for where it might be at the end of 2022 here?
Olivier Taelman - CEO & Executive Director
Yes, no, and I really like this question because this is really a question where I'm extremely proud on my German team. We define our commercial success from the get-go by saying we want to exit in 2022 as market leader in Germany. Today, we are roughly at 30% of market share to your point. And to answer your question for Q4, and this is the challenge my German team and myself we are taking. We are still saying that we will exit Q4 as market leaders in Germany, and this has not changed.
And I hope that during our next earning call, I can confirm this, you can be very certain that when we did this, there will be very strong German celebration taking place because if we could do this, it would be an extremely strong performance. And we see everything lined up to really accomplish this.
Unidentified Analyst
Excellent. And then just thinking about what could possibly go wrong, any staffing shortages in the field today that are impacting PSG labs? And if so, is that impacting procedure volume or how is it?
Olivier Taelman - CEO & Executive Director
From a staffing perspective, also there, you see a lot of momentum. So we have today 15 German dedicated Nyxoah people, both in sales and marketing. Like we have centers that are reaching out to us, we're also seeing that people start reaching out to us and saying, okay, guys, are you investing, are you hiring at this moment? So there also, we find this really excitement.
Next to this, I mentioned the Care4 program that we are rolling out, in a nutshell, what is this. I think with this Care4 program, we have a home sleep test that we are using and offering to sleep physicians in order to validate, in fact, existing PSGs and that will, of course, give also patients a shorter pathway directly to the Genio solution than when they have to wait and to undergo a lot of PSG. So we are really investing. We also invest in the helpline that we have now in place.
We are seeing that next to our ENT surgeons that we're also working with them together also in strengthening the referral network. So all these investments we are making and then that has really given us confidence that Germany will continue growing and that Nyxoah will also continue growing very strong, and of course, resulting in a market leader position.
Unidentified Analyst
Okay. And then if I could just squeeze in one last numbers question for Loic. I realize you don't give guidance in general, but do you see 4Q gross margin kind of similar to the 65.3% we saw here in 3Q or might there be any component costs or other pressures from the 3Q supply disruption we saw?
Loic Moreau - CFO
Thank you for -- thank you for the question. So as you pointed out in term of gross margin, we have 65% (sic) [65.3%] in Q3. We expect this gross margin to remain fairly stable in the last quarter with additional volumes we are building at the moment. So we don't expect adverse gross margin impact from the supply disruption we had in Q3. We have resumed quite quickly, and we are now catching up in term of production and batches.
Unidentified Analyst
That's great to hear.
Operator
At this time, I'm showing no further questions. I would now like to turn the conference back to Olivier Taelman for closing remarks.
Olivier Taelman - CEO & Executive Director
Thank you. So once again, thank you all for joining and listening in, and thank you all for your questions. The conclusion that I would like to make is that we see great traction in the DREAM study. We feel confident in showing our clinical data by fall 2023 and also not changing any of our time lines in getting regulatory approval in the U.S. It was very inconvenient the manufacturing issue we went through, but we solved it, we fixed it.
We saw no impact. We saw no decrease in demand at all. We expect also a very strong Q4 in our commercial launch in Germany -- so -- also there. So once again, I can only thank the team, we will continue executing strong. And we are looking forward to report on our Q4 call during the next earning call. Thank you, all.
Operator
This concludes today's conference call. Thank you for participating. You may now disconnect.