Good morning, everyone, and I welcome you to our first quarter of twenty twenty five earnings call. Participating from the company today will be Olivier Talmon, Chief Executive Officer and John Landry, Chief Financial Officer. During the call, we will discuss our operating activities and review our first quarter twenty twenty five financial results released before U. S. Market opening 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 on the Investor Relations tab of our website. Before we begin, I'd 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 forward looking 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 the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these forward looking statements.

For a list and description of these 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 03/20/2025. With that, I will now turn the call over to Olivia.

Thank you, Pearson.

Good day everyone and thank you for joining us for our first quarter twenty twenty five earnings call. Before we start, I'd like to welcome Berson Dennis who recently joined us as our Investor Relations Associate. I'd like to focus today's discussion on our path to full PMA approval in The United States. We announced in March, the FDA issued an approval letter for our GENEOS system. Which confirms that our application substantially meets the requirements for marketing in The US. Importantly, the FDA accepted our usability studies, clinical data demonstrating safety and effectiveness of the GENEOS system. Just to highlight a few components of our submission. Following receipt of the approval letter, FDA will approve the application subject to satisfactory completion of manufacturing facilities, methods and control reviews. In that context, the FDA requested validation of one specific manufacturing process at The U. S. Contract manufacturing site. I am pleased to report that Roktima successfully completed this validation work and submitted the required documentation to the FDA. FDA reviewed this validation already and has confirmed they have no further questions regarding it. As a final step, the FDA is now conducting an on-site inspection of The US contract manufacturing facility.

Which we expect to be completed shortly. This site already successfully passed an FDA inspection as part of our PMA process with no deficiencies. We are confident in our ability to complete this final step in the process And based on this timeline, continue to expect to receive PMA approval in the second quarter of twenty twenty five. In preparation of our U. S. Commercial launch, we have built a world class team in support of our US go to market strategy. In addition, we have put in place industry leading talents with a track record in neuromodulation and or obstructive sleep apnea. Or OSA. Because of sales marketing, reimbursement and medical affairs teams in The US. Our strategy for penetrating The U. S. Market is focused on a two pronged approach. First, as a smart follow-up, we will target high volume epoglossal nerve stimulation implanting centers where patients and physicians are actively seeking an alternative solution to current therapy. Market research confirmed significant demand from patients are hesitant about receiving a pacemaker platform technology including an implanted battery which currently requires a subsequent surgery to replace it. Research also indicates that physicians are eagerly awaiting a compelling alternative to further expand their OSA treatment options.

This is consistent with feedback from the 75 US physicians that already have been trained on the GENEO technology giving their participation our clinical trials usability studies. And became familiar with Genio's unique features and patient outcomes. Second, we will develop strong networks with sleep physicians. Who manage large populations of moderate to severe OSA patients where heteroglossal neurostimulation is not yet fully embedded as part of their treatment pathway. As a company that prioritizes clinical evidence and patient outcome, oversimplified marketing messages, we believe in setting realistic patient expectations and partnering with physicians to find the optimal treatment for each patient as part of our mission in putting patients first. We are ready to launch in The US with 50 commercial team members are all hired and trained. This team is comprised of sales marketing, market access professionals, who will be supported by focused direct to consumer or DTC initiatives. And dedicated reimbursement support. We plan to scale up U. S. Commercial team each quarter post FDA approval. Hand in hand, the opening of new implanted cards. Regarding reimbursement, we are working closely with the American Academy of Otolaryngology and participating in the FDA's early payer feedback program. To educate CMS and major commercial payers on the genome system and the clinical impact it can have on the OSA patient population.

We have identified an established CPT code that we plan to utilize at launch. The CPT code to be very precise is 64568. This CPT code has been recognized by commercial and government payers for OSA indications and is the same CPT code used for the current FDA approved AGNS technology. We expect that our pricing will be similar to our AGNS competitors while we differentiate Oxtel's via our unique technology benefits and clinical outcomes. Receiving FDA approval will represent the culmination of rigorous clinical research technological innovation, and strategic preparation. We look forward launching Xeno in The US upon receipt of FDA approval. Bringing a revolutionary overseas solution. To patients who have been waiting for an alternative that can truly transform their quality of life long term health outcomes. With that, I'll turn the call over to our CFO, John Laundry for the financial update. Thank you Olivier.

We recorded revenue of 1,100,000.0 Euro in the first quarter of twenty twenty five compared to €1,200,000 in the first quarter twenty twenty four. The slight year over year revenue decrease was primarily due to temporary softness in the international HD and S market. We also launched our Genio 2.1 patient software upgrade commercially, via a phased approach which resulted in certain Genio sites deferring their purchase until the upgrade of patient software was available to them. We expect these factors will normalize in the upcoming quarters. Total operating loss for the first quarter of twenty twenty five was €20,600,000 versus €12,200,000 in the first quarter twenty twenty four, driven by investments in the U. S. Commercial organization in preparation for FDA approval and subsequent commercial launch. Our cash position was €63,000,000 at 03/31/2025. Compared to €85,600,000 at the end of twenty twenty four. With that, I'd now like to hand the call back to Olivier to discuss his thoughts for the remainder of 2025. Olivier? You, Joel. What sets Nyxoah apart the OSA treatment landscape is of patient first approach and unique therapy which mitigates the limitation of implantable pacemaker technologies. We have designed the Genius System with patient comfort convenience as priorities.

No implanted battery bilateral stimulation for consistent therapy regardless of patient's sleep position. And the single incision procedure. All supported by strong clinical data demonstrating the safety and effectiveness. Importantly, we are the only company clinical data in positional OSA. And supine sleep time. The US represents not just our largest market opportunity, but also a chance to meaningfully change the standard of care for millions struggling with moderate to severe OSA. With our commercial team in place, our reimbursement pathway established we are positioned at the starting line of what we believe will be a significant growth trajectory once we have FDA approval. The enthusiasm we have seen from the clinical community during our trials reflect what we have known all along. Patients and physicians are looking for meaningful innovation in OSA treatment options. Our approach addresses specific limitations have affected patient adoption and treatment outcomes with existing therapies. As we stand on the work of FDA approval, we have never been more confident in Nyxoah's future and our ability to deliver value to patients physicians, and shareholders alike With that, I would now like to open the line for question and answers.

Our first question comes from the line of Jon Block from Stifel.

Thanks, guys. Good morning. Olivia, can you talk about what needs to get done at this US inspection versus the initial one that took place call it earlier in the FDA process.

Yes. Hello, John. Thank you for the question. So to be very precise, we were informed by FDA to do a validation of a specific manufacturing process at the contract manufacturer in The U. S. Start by doing this administrative and also show protocols and how you validate certain processes that have been done, submitted, and accepted by FDA. So that part is off the table. As part of the regulatory process, a site visit to confirm that this validation is standard practice after the first step of the validation and that is ongoing as we speak.

Okay, I think I got that. Just one follow-up to my first question for clarification.

When you see the physical site inspection is ongoing, you know, has that again, it's a physical site inspection.

So has that occurred? Have they been out to the site? Is there a date for the site inspection? I'm just trying to get as granular as possible while still being sort of respectful to the process, if you would.

Yes. So definitely. So the site inspection is actively taking place as we speak. Normal process of a site inspection is that it can last up to five days. We don't know. It's all in the hands of the inspector that is visiting our contract manufacturer. After this, he will finish his report. He will submit the report to FDA, to the PMA review committee, and then at that point, they can issue us an approval. And that's also why we stay confident that we will obtain the approval by the end of two.

Okay, very helpful. And then just for the second question to shift gears as we think about the market launch and the commercialization, can you talk about the company's strategy to have sort of outreach to the ENT, where I'm guessing you know, if you get it on the label, the no contraindication on CCC might mean a lot. Versus the outreach to the sleep doc where again, I'm hypothesizing but the supine data might resonate a little bit more because obviously the sleep is the one with the ongoing management of that patient. So, two very different variables when we think about differentiation on the label that's [indiscernible] Can you talk about the outreach on one versus the other and how the company will tackle that? Thank you.

Yes, okay. I will try because you're asking several questions at the same point. So let's talk with the clinical aspect. As I mentioned, always, GENUE was designed with the patient focus and centric in mind. So that is one aspect of this. And therefore, we are extremely proud that we were able to demonstrate this in robust clinical data showing the differentiation compared to what competition is offering today. Solid concrete, are the only company that can offer clinical data and showing a effectiveness in supine sleep position and also helping patients that are suffering from positional OSA. That's one clear differentiation point when it comes to our patient centric focus. That's one aspect. Now linking this to the label, because that was the second part of your aspect, of course, in our label submission to FDA, are highlighting this and I cannot jump to conclusions yet because we haven't seen the published labels from FDA because then those handed out with an approval. But it is clear that the discussions and the way we position the Meroc case was clearly well perceived by FDA. So yes, we do expect that FDA will also build this in our labeling.

So differentiating supine data positional assay. And then the last part of the question was CCC patients. As you know, we already have CCC on label all international markets. We are seeing great results in the markets where we are commercially available on CCC patients. We are conducting a specific study in The US called ACCESS treating those CCC patients and also here we do think it will make sense that over time we will add the CCC label in The US and to start with, CCC would not be reflected as a contraindication in the label that will be issued and going forward. But again, we will have to wait upon FDA approval have the final confirmation of all this.

Understood. Thanks for the color guys.

Thank you.

One moment for our next question. Our next question comes from the line of Adam Meter. From Piper Sandler.

Hi, good morning, Olivier.

And John. Thank you for taking the questions. The first one for me, just on FDA approval process.

Great to hear you reiterate the Q2 FDA approval expectation. And to hear that the final site inspection is ongoing. My question is, I'm wondering if there's any kind of statutory response time from FDA associated with this process. And really, I'm just trying to kind of better understand what's in informing the confidence that U. S. Approval is going to come either later this month or next? And then I had a follow-up or two. Thanks.

Yes. Nice to hear you, Adam. First of all, let me repeat the final steps. So there is currently an inspection that is taking place. Once the inspection is finished, then there will be a final report completed and submitted to the FDA PMA review committee. And at that point, FDA has all the information needed also issue an approval. As I keep repeating about the previous timeline, before the end of Q2, we are feeling confident that we will obtain the FDA approval by just highlighting again the steps that we are facing that we are going through as we speak. [indiscernible] Okay, understood. And then for the the next question, I just wanted to see if there was an update around timing for the Dream Journal publication. Just any visibility into when that could be published?

Definitely. So we submitted the publication to a leading industry journal. Also here there is a clear review process We have passed the first acceptance barrier, as they like to refer to, So now we are in the second level of review. We got some questions already from the reviewers that we are answering and addressing. So if you add all these up, I do think that before summer starts, should be able to have a publication out.

Okay. Fantastic. And just one more from me, if that's okay, and then I'll hop back into queue. For John, just wanted to ask about the pace of OpEx spending going forward. Any qualitative or quantitative color that you're willing to share as we think about the next couple of quarters as you guys get ready to launch this in The U. S. Would be be helpful. Thank you.

Sure. Yes, Adam, good to hear from you. From an FDA timeline perspective, obviously, we've taken steps to defer costs and the investments until our FDA approval is achieved and received. So, we've taken steps in terms of deferring commercial related investments that naturally go hand in hand with revenue, and we also have a number of other levers we've pulled in the P and L to extend our track cash runway as well into the second quarter of twenty twenty six.

Okay. John, any just finer point around kind of how we should think about R and D and SG and A kind of going forward, I guess, the genesis of the question was it came in a little bit more heavy handed than we were modeling So just trying to kind of wondering if you can kind of orient us into a ZIP code spend going forward. Thanks.

Sure. Absolutely. From an R and D perspective, I'd expect the full year to be probably in line with where we were from 2024 perspective. And then from a sales and marketing perspective, SG and A perspective overall, I would expect that to be a little bit more than double what we had incurred in 2024. And then when you look at it, for the full year, we'll be from a timing perspective, you know, the first couple of quarters are probably going to be a little bit heavier than the back quarters of the year.

That's really good color. Appreciate it. Thank you.

You're welcome, Adam.

Thank you. One moment for our next question. Our next question comes from the line of Ross Osborne. From Cantor Fitzgerald.

Hey guys, thanks for taking our questions. Starting off with the curious to hear how the commercial launch of Nyxo in Dubai is progressing. And how you're thinking about the allocation of resources given Middle East is obviously a large and underserved market? But focus is likely on The U. S. In the near term.

Yes. So thank you also for the question. So yes, it's great that with GINEO we are the first AGNS company that is implanted in The Middle East. Dubai was the first hospital in Dubai, we had the first hospital where we had two successful implants to start with. We are opening a second hospital in Dubai and then we are also looking at Kuwait and Saudi Arabia to go further. So yes, I do think great milestone entering The Middle East and offering also their AGL solution for the patients. First implants taking place, training education put in place and we are educating some very specific sites spread over The Middle East where we will be further implanting in quarter two, quarter three and beyond.

Great. And then apologies if I missed this. Any update on the access study in terms of where you stand with implants?

No, absolutely no problem. But on access as communicated, we keep making great progress in enrolling patients. So we are always talking about stopping of the enrollment by summer. So, that timeline hasn't changed. And once we have this, the next step will be twelve month data. Once we have those data, submitted as a PMA supplement and then negotiating further on FDA on how this can expand our label in The U. S. Adding CCC patients.

Great. Thanks for taking our questions.

Thank you.

One moment for our next question. Next question comes from the line of Suraj Kalia from Oppenheimer and Company.

Good morning, Olivier and John.

Hey, Olivia. So you for providing a lot of details. You've consistently said that the initial target for Genio would be, you know, 75 physicians have been trained, The 300 or so top HGNS sites My specific question, Olivier, is as we understand it, you know, there are, like, 10 or so units h e n s units already on the shelves for these top sites. How do you envision would you all also I shouldn't say mandate, but require some of the sites to have a certain minimum unit upfront purchases How are you gonna do you think existing inventory would be an issue as you roll out into existing sites? The top sites?

Yeah. Most of us, I nice to hear you and thank you for the commercial question. If I can refer to this like this. So first of all, I would like to highlight that over 100,000 patients have received A GNS treatment. And why do I want to start with this in The US? It's just indicating that when you look at high volume sites, that 10 implants or having an inventory of 10 products it will be easily absorbed in a couple in a couple of weeks. So I don't see an issue of having current inventory of competition because that's the only company out there would be a hindering factor also in launching Genio and going forward. So that's the first answer. The second answer to the question is that when working with the 75 surgeons and also with the hospitals, it's also clear that we will have to make sure that [indiscernible] When passing this, we also start planning off time and also scheduling real time patients. And once we are doing this, we will make sure that we have colleagues available at the hospital to treat those patients. But it will not be a strategy where we are loading shelves even before we identify patients.

I think the healthiest best to start is also you identify patients, you have your oral dates, and you make sure you have your products available including some backups in case there would be a need for more than one product.

Got it.

Apologies for the background.

So, Olivier, if I could, send a couple of two part question your way quickly. So the regions where your sales force has been hired, how would you any additional color you can give us there? And the second question the second part of the question, Olivia, as you all roll out Genio commercially, what do you expect to do in terms of DTC? How are you expecting to be different? Than Inspire? Thank you for taking my questions.

Yes, definitely. So Suraj, we have been planning very carefully and studying The U. S. Market. It starts with heat maps that they are called like where are the high volume sites. Have access to this. Based on this, we also combined with the surgeons that already are experienced with our product and we did some further market research So we mapped out to the entire AGNS market in The U. S. Using heat mapping, and then we start building and hiring of our sales force accordingly. So that's the answer to the first part of the question. The second one on DTC, a whole lot will be different. We are different that we will not have sucralose commercials. I to say something maybe a little bit funny, but we will not have this huge DTC outreach as known today by AGNS competitor We will work very focused. We will work around sleep sites where they can also through DTC specifically address and provide patients access to know what would be the best technology available to treat their OSA Once we have identified these patients and those patients came forward with sleep doctors, then of course, we do further invest in a very focused manner to drive these patients to the ENT surgeon where then they can further discuss and end up with a genuine brand.

Got it. Thank you.

Thank you. One moment for our next question. Our next question comes from the line of David Ray Scott from Baird. Great. Thanks for taking the questions. Olivia, I wanted to ask on 2.1. I think you called out that in in Europe with the rollout there, software update, there was some delays in implants.

So when you think about I guess, first part of the question is going to be curious on 2.2 or kind of just future software upgrades as you come to The U. S. But when you think about the rollout in The US and the potential for there to be future maybe updates here, I guess, how do you smooth out that kind of transition and so that you don't have delays or patient warehousing at all on implants when new system updates are ultimately rolled out and next couple of years? Yeah, thank you for this question, David. And it's a very important one and I will start and then John will definitely step in. On the second part of this question on rollout and how do we further scale up. But as I mentioned in the beginning, it is so important for Nyxoah to offer patient centric solutions. And the Genio 2.1 software upgrade is a clear example in how our therapy is different compared to a pacemaker platform technology. More concrete, the software upgrade provides the opportunity for a patient to gradually increase stimulation which will result in an improvement of patient comfort. So it gives the patient the comfort, and it gives the physician the option to gradually ramp up stimulation enabling him also to treat patients that might be sensitive previously when treated with stimulation that now all of a sudden become eligible.

So that is one aspect of the upgrade. The second one is also providing the patient with autonomy to increase or decrease stimulation settings within predefined boundaries set by the physician. Now, once you start providing a patient with that autonomy, it also increases the compliance of technology patients feel they're in control and they can find their optimal comfort. So combining those two upgrades in one software upgrade is really contributing to our mission in having a patient centered solution. Now, how do you own this out? I will hand it over to John because I know he's working very closely with our manufacturing team on this. And maybe you can provide some more color, John. Excellent. Thank you, Olivier. Yes. So to your to your point David, we had a few orders that we didn't ship out this past quarter. Because one, the customers and the customers wanted to have the latest upgraded activation chip for their customers. Had we shipped those, we've seen low double digit growth in the first quarter of twenty twenty five versus first quarter of twenty twenty four. What we're looking to do in The U. S, we'll have our JYNNEO 2.1 available for all customers.

So as we enter the market, we won't have a switch from the Genio two point zero to the 2.1. So we'll be ready to roll from that perspective as we enter into The US market.

Okay, thanks. And then on the reimbursement front, you've been consistent on the coach you're going to go after. I'm curious what you're doing maybe on the back end to, you know, ensure that when the rollout happens that you will be able to to map to that or or use that code and and if the, you know, case by case implants are maybe a little tougher than you anticipate, do you expect to have a built out back end kind of reimbursement team to really help streamline pushing these patients through and getting coverage when you all enroll out in The U. S? Thank you.

Thanks for the question, David. Yes, so short answer. We have a team market access team that's dedicated to helping us work through that process. They have a lot of experience specifically in the neuromodulation space. So as we work through the rollout we have very specific materials that we're utilizing to help our sales force and then our market access teams navigate and work through the pre authorization process for these particular patients as they make their way into the facility. So again, have a strong team in place that's growing and we'll be well prepared to help with that process as we enter new accounts in The US. [indiscernible] And maybe I just try to further elaborate on this one.

It's always nice to be second meaning that there was a lot of heavy lifting done by competition. There is a code the 64568 that is a well established and recognized code by payers, both government and commercial payers. For the specific OSA indication where we also are positioned in So, yes, we do feel confident that this barrier or this route is also successfully taken and will result in a quick revenue generation. Thank you.

Thank you. One moment for our next question. Our next question comes from the line of Michael Pollard. From Wolfe Research.

Hey, good morning. I want to follow-up on the triple discussion and make sure I I hear this clearly. It sounds like this initial FDA approval will not it sounds like it will have the CCC contraindication, and the FDA is not willing to not have that with your pre limb access data, and so we need to follow access through to completion to remove the contraindication. Is that am I hearing the message correct? Is that the current expectation?

No, it is not. Let me be very precise on this Mike. So, you know that there is off label, there is on label, but there are also steps in between and you need to be very very precise. We don't expect to have CCC as on label the simple reason that in the DREAMM study, we did not implant it CCC patients. So that's I think I hope this is very clear. Second thing is when we look at the CCC work that is ongoing in The U. S. In access, but also the previous CCC work and experience that we are having, there is no indication that Gnu is not working for CCC patients and therefore there is also not one reason that would point in the direction that CCC should be a contraindication. So, what we do expect is, we expect that in our label we do not have it on label, but we also expect that we will not have it as a contraindication, but simply as an off label indication that is up to the physician's decision whether they would offer this to their patients. Yes or no. I hope this is answering your question because I want to evaluate it in this.

Yes.

Thank you. And so [indiscernible] as you launch this, will you be an advocate for the DICE procedure ahead of a Genio implant? How are you thinking about that given labeling expectation for CCC?

So first of all, it's clear that we will never promote anything that is not on label or that is off label and we will never do this. And if you then take it to the next port, how can a physician be certain that a patient is not having CCC? Yes, they will have to do the dice. That is currently still the most by traditional and accepted measurements to exclude CCC. I also know and we also that there is some work being done by others also in, for example, measuring the pharyngeal with the moment that that would become accepted by payers to exclude CCC patients, it's clear that we will also adapt to this. But with our current data, of DREAM, it is also obvious that we will have to exclude CCC and that we will not actively promote this when launching the product.

Thank you, Olivier.

Thank you, Mike.

Thank you. One moment for our next question.

Our final question comes from the line of Laura Roba. From Degroof Petercam. Good afternoon. Thank you for taking my question.

First of all, would like to come back on the previous question because you mentioned, John, of your level other levers to extend the cash runway into Q2. So could you elaborate on this? And then a second one on the temporary softness in the AGMS market. Could you provide also a bit more information on this? Also your expectations going forward? Thank you.

Sure. So I'll start with the last piece.

The temporary softness in the market. We also saw our competitor in the first quarter also posted a mid single digit decline in the international market. We saw some softness there.

Seasonality. We expect it to be temporary in nature and to recover over the course of the year. With regard to some of the other discretionary spending, when we build our P and L. We obviously have a number of fixed expenses, we also have variable expenses. When we look at the variable expenses, they're discretionary in nature, whether they're projects or other commercial related items related to launch specifically. We've elected to defer those to be more in line obviously within FDA approval timeline, as well as to extend some of the other projects that are ongoing that are not essential to either FDA approval status or immediate launch, we'll be deferring those to a later date. To extend that cash runway.

So So those are some of the nature of the items that we're deferring to extend the runway out.

Okay, thank you. Thank you.

At this time, I would now like to turn the conference back over to Olivier Tauman, Chief Executive Officer, for closing remarks.

So first of all, I would like to thank everyone for attending the call. As we stand on the verge of FDA approval, we have never been more concerned in Nyxoah's future and our ability to deliver value to the patient's physicians. And also shareholders. So thank you again for your time today. And your continued support of Nyxoah and we are really looking forward to updating you on our progress in the coming weeks slash months. On FDA to be very precise. Thank you all for joining.

This concludes today's conference call. Thank you for participating. You may now disconnect.