Nyxoah S.A. (NYXH) Q1 2025 Earnings Report, Transcript and Summary

Good day and thank you for standing by. Welcome to the Nyxoah First Quarter 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [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, Pearson Dennis, Investor Relations Associate. Please go ahead.

Thank you. Good morning everyone and I welcome you to our first quarter of 2025 earnings call. Participating from the company today will be Olivier Taelman, Chief Executive Officer; and John Landry, Chief Financial Officer. During the call, we will discuss our operating activities and review our first quarter 2025 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 and 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 March 20, 2025. With that, I will now turn the call over to Olivier.

Thank you, Pearson. Good day everyone and thank you for joining us for our first quarter 2025 earnings call. Before we start, I'd like to welcome Pearson 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. As we announced in March, the FDA issued an approvable letter for our Genio system which confirms that our application substantially meets the requirements for marketing in the U.S. Importantly; the FDA accepted our biocompatibility testing, usability studies, clinical data demonstrating safety and effectiveness of the Genio system, just to highlight a few components of our submission. Following receipt of the approvable letter, the FDA will approve the application subject to satisfactory completion of manufacturing facilities, methods and control reviews. In that context, the FDA requested a validation of one specific manufacturing process at the U.S. contract manufacturing site. I am pleased to report that our team has 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 U.S. 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, we continue to expect to receive PMA approval in the second quarter of 2025. In preparation of our U.S. commercial launch, we have built a world-class team in support of our U.S. 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, across our sales, marketing, reimbursement and medical affairs teams in the U.S. Our strategy for penetrating the U.S. market is focused on a two-pronged approach. First, as a smart follower, we will target high-volume hypoglossal nerve stimulation implanting centers where patients and physicians are actively seeking an alternative solution to current therapy. Market research confirms significant demand from patients who 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 U.S. physicians that already have been trained on the Genio technology, given their participation in our clinical trials and 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 hypoglossal nerve stimulation is not yet fully embedded as part of their treatment pathway. As a company that prioritises clinical evidence and patient outcome over simplified 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 U.S. with 50 commercial team members who 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 our U.S. commercial team each quarter post FDA approval, hand-in-hand with the opening of new implant accounts. 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 Genio system and the clinical impact it can have on the OSA patient population. We have identified an established CPT code that we plan to utilise at launch. The CPT code, to be very precise, is 64568. This CPT code has been recognised by commercial and government payers for OSA indications and is the same CPT code used for the current FDA-approved HGNS technology. We expect that our pricing will be similar to our AGNS competitor while we differentiate ourselves 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 to launching Genio in the U.S. upon receipt of FDA approval, bringing a revolutionary OSA solution to patients who have been waiting for an alternative that can truly transform their quality of life and long-term health outcomes. With that, I'll turn the call over to our CFO, John Landry, for the financial update.

Thank you, Olivier. We recorded revenue of €1.1 million in the first quarter of 2025 compared to €1.2 million in the first quarter of 2024. The slight year-over-year revenue decrease was primarily due to temporary softness in the international HGNS 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 normalise in the upcoming quarters. Total operating loss for the first quarter of 2025 was €20.6 million versus €12.2 million in the first quarter of 2024, driven by investments in the U.S. commercial organisation in preparation for FDA approval and subsequent commercial launch. Our cash position was €63 million at March 31, 2025, compared to €85.6 million at the end of 2024. With that, I'd now like to hand the call back to Olivier to discuss the thoughts for the remainder of 2025. Olivier?

Thank you, John. What sets Nyxoah apart in the OSA treatment landscape is our patient-first approach and unique therapy which mitigates the limitation of implantable pacemaker technologies. We have designed the Genio system with patient comfort and convenience as priorities. No implanted battery bilateral stimulation for consistent therapy regardless of patients' sleep position and a single incision procedure, all supported by strong clinical data, demonstrating the safety and effectiveness. Importantly, we are the only company with clinical data in positional OSA and Supine sleep time. The U.S. 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 that have affected patient adoption and treatment outcomes with existing therapies. As we stand on the verge 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 questions and answers.

[Operator Instructions] Our first question comes from the line of Jon Block from Stifel.

Olivier, can you talk about what needs to get done at this U.S. inspection versus the initial one that took place, call it, earlier in the FDA process?

Yes. Jon, 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. You start by doing this administratively and also show protocols and how you validate certain processes that has 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 say the physical site inspection is ongoing, 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 of the process if you would.

Yes. So definitely. So, the site inspection is actively taking place as we speak. Normal process of site inspection is that it can last up to 5 days. We don't know. It's all in the hands of the inspector that is visiting our contract manufacturers. 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 the quarter.

Okay, very helpful. And then just for the second question to shift gears. As we think about the market launch and the commercialisation, can you talk about the company's strategy to have sort of outreach to the ENT, where I'm guessing 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 hypothesising 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, 2 very different variables when we think about differentiation on the label that's possible. Can you talk about the outreach on one versus the other and how the company will tackle that?

Yes. Okay. I will try because you're asking several questions at the same point. So, let's start with the clinical aspect. As I mentioned, always, Genio was designed with the patient focus and centric in mind. So that is one aspect of this. 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. We are the only company that can offer clinical data and showing 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. So 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, we are highlighting this. And I cannot jump to conclusions yet because we haven't seen the published label from FDA because that goes hand-in-hand with an approval. But it is clear that the discussions and the way we positioned and made our case was clearly well perceived by FDA. So yes, we do expect that FDA will also build this in our labelling. So, differentiating Supine data additional OSA. And then your last part of the question was CCC patients. As you know, we already have CCC on label in our international markets. We are seeing great results in the markets where we are commercially available to CCC patients. We are conducting a specific study in the U.S. called ACCCESS 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 U.S. and to start with, CCC would not be reflected as a contraindication in the label that will be issued going forward. But again, we will have to wait upon FDA approval to have the final confirmation of all this.

Our next question comes from the line of Adam Maeder from Piper Sandler.

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 the FDA associated with this process. And really, I'm just trying to kind of better understand what's informing the confidence that the U.S. approval is going to come either later this month or next? And then I had a follow-up or two.

Yes. Nice to hear you, Adam. So, 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 to also issue an approval. As I keep repeating what our previous timeline before the end of Q2, we are feeling confident that we will obtain the FDA approval. I'm just highlighting again the steps that we are facing that we are going through as we speak.

Okay. Understood. And then for 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 this up, I do think that before summer starts, we should be able to have a publication out.

Okay. Fantastic. And just one more for me, if that's okay and then I'll hop back in the queue. For John, I 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 helpful.

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&L to extend our cash runway as well into the second quarter of 2026.

Okay. John, any just finer point around kind of how we should think about R&D and SG&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 for spend going forward.

Sure. Absolutely. From an R&D perspective, I'd expect the full year to be probably in line with where we were from a 2024 perspective. And then from a sales and marketing perspective, SG&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 will be, from a timing perspective, the first couple of quarters are probably going to be a little bit heavier than the back quarters of the year.

Our next question comes from the line of Ross Osborn from Cantor Fitzgerald.

Starting off, I would be curious to hear how the commercial launch of Genio in Dubai is progressing and how you're thinking about the allocation of resources given the 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, Ross, for the question. So yes, it's great that with Genio, we are the first AGNS Company that is implanting in the Middle East. Dubai was the first hospital. In Dubai, we had the first hospital where we had 2 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 there AGNS as a solution for the patients, first implants taking place, training and education put in place and we are educating some very specific sites spread over the Middle East, where we will be further implanting in Q2, Q3 and beyond.

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

No, absolutely no problem. But on ACCCESS, as communicated, we keep making great progress in enrolling patients. So, we were always talking about stopping the enrollment by summer. So that time line hasn't changed. And once we have this, the next step will be 12-month data once we have those data submitted as a PMA supplement and then negotiating further or discussing further with FDA on how this can expand our label in the U.S., adding CCC patients.

Our next question comes from the line of Suraj Kalia from Oppenheimer & Company.

Olivier, so thank you for providing a lot of details. You've consistently said that the initial target for Genio would be 75 physicians have been trained, the 300 or so top AGNS sites. My specific question, Olivier, is, as we understand it, there are like 10 or so units, at AGNS 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 going to, do you think existing inventory would be an issue as you roll out into existing sites, the top sites?

Yes. Suraj, nice to hear you and thank you for the commercial question, if I can refer to it like this. So, first of all, I would like to highlight that over 100,000 patients have received AGNS treatment. And why do I want to start with this in the U.S.? It's just indicating that when you look at high-volume sites that have 10 implants or have an inventory of 10 products, it will be easily absorbed 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 that 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 we pass the audit committees that when passing this, we also start planning over time and also scheduling real-time patients. And once we are doing this, we will make sure that we have products 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 base to start is also to identify patients, you have your audits and you make sure you have your products available, including some backups in case there would be a need for more than one product.

Okay. So, Olivier, if I could send a couple of 2-part questions your way quickly. So, the regions where your sales force has been hired, so would you, any additional color you can give us there? And the second question, the second part of the question, Olivier, 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?

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. We 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 our sales force accordingly. So that's the answer to the first part of the question. The second one on DTC, how are we different? We are different that we will not have Super Bowl commercials. And 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 patient’s 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 will 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 the Genio implant.

Our next question comes from the line of David Rescott from Baird.

Olivier, I wanted to ask on Genio 2.1. I think you called out that in Europe with the rollout there of the software upgrade, there was some delays in implants. So, when you think about, I guess, first part of the question is going to be curious on Genio 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 U.S. 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 the implants when new system updates are ultimately rolled out in the next several years?

Yes. No, 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. Now 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 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 2 upgrades in one software upgrade is really contributing to our mission in having a patient-centered solution. Now, how do you roll this out? I'm going to 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 point, David, we had a few orders that we didn't ship out this past quarter because one, the customers and their customers want to have the latest upgraded activation chips for their customers. Had we shipped those, we've seen low double-digit growth in the first quarter of 2025 versus first quarter 2024. What we're looking to do in the U.S., we'll have our Genio 2.1 available for all these customers. So, as we enter the market, we won't have a switch from the Genio 2.0 to the 2.1. So, we'll be ready to roll from that perspective as we enter into the U.S. market.

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

Yes. 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, we 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 U.S.

And maybe just 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 of this order is also successfully taken and will result in a quick future patient.

Our next question comes from the line of Michael Polark from Wolfe Research.

I want to follow up on the CCC discussion and make sure 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 prelim 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. And 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 to be very, very precise. We don't expect to have CCC as on label for the simple reason that in the DREAM study, we did not implanted 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 Genio 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 won't have anything else on this [ph].

And so related, as you launch this, will you be an advocate for the DISE procedure ahead of a Genio implant? How are you thinking about that given this labeling expectation for CCC?

Yes. 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 part, how can a physician be certain that a patient is not having CCC; yes, they will have to do the DISE. That is currently still the most traditional and accepted measurement to exclude CCC. I also know and we also know 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.

Our final question comes from the line of Laura Roba from Degroof Petercam.

First of all, I would like to come back on the previous question because you mentioned, John, 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 HGNS market. Could you provide also a bit more information on this and also your expectations going forward?

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&L, we obviously have a number of fixed expenses but 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, with an FDA approval time line 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 those are some of the nature of the items that we're deferring to extend the runway out.

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

So first of all, I would like to thank everyone for attending the call. And as we stand on the verge of FDA approval, we have never been more confident in Nyxoah's future and our ability to deliver value to the patients, 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/months on FDA to be very precise. Thank you for joining [ph].

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