NASDAQ:NYXH Nyxoah Q1 2025 Earnings Report $7.71 -0.01 (-0.13%) Closing price 06/5/2025 04:00 PM EasternExtended Trading$7.51 -0.20 (-2.59%) As of 09:22 AM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast Nyxoah EPS ResultsActual EPS-$0.63Consensus EPS -$0.49Beat/MissMissed by -$0.14One Year Ago EPSN/ANyxoah Revenue ResultsActual Revenue$1.12 millionExpected Revenue$1.64 millionBeat/MissMissed by -$516.00 thousandYoY Revenue GrowthN/ANyxoah Announcement DetailsQuarterQ1 2025Date5/14/2025TimeBefore Market OpensConference Call DateWednesday, May 14, 2025Conference Call Time8:00AM ETUpcoming EarningsNyxoah's Q2 2025 earnings is scheduled for Tuesday, August 5, 2025, with a conference call scheduled on Wednesday, August 6, 2025 at 2:00 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Earnings HistoryCompany ProfilePowered by Nyxoah Q1 2025 Earnings Call TranscriptProvided by QuartrMay 14, 2025 ShareLink copied to clipboard.PresentationSkip to Participants Operator00:00:00Good day and thank you for standing by. Welcome to the Nixoa First Quarter twenty twenty five 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. Please be advised that today's conference is being recorded. Operator00:00:33I would now like to hand the conference over to your speaker today, Pearson Dennis, Investor Relations Associate. Please go ahead. Pearson DennisInvestor Relations Associate at Nyxoah00:00:42Thank you. 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. Pearson DennisInvestor Relations Associate at Nyxoah00:01:05Market 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. Pearson DennisInvestor Relations Associate at Nyxoah00:01:38These 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 03/20/2025. With that, I will now turn the call over to Olivier. Olivier TaelmanCEO & Executive Director at Nyxoah00:02:22Thank 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 Bersen 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 approval letter for our GENEOS system, which confirms that our application substantially meets the requirements for marketing in The US. Olivier TaelmanCEO & Executive Director at Nyxoah00:02:56Importantly, the FDA accepted our biocompatibility testing, 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, the 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 US 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:03:46As 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 we continue to expect to receive PMA approval in the second quarter of twenty twenty five. In preparation of our U. S. Olivier TaelmanCEO & Executive Director at Nyxoah00:04:20Commercial 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:04:43Our 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 confirmed 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:05:18Research 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 GENEEL technology giving their participation in our clinical trials and usability studies and became familiar with the Genius 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 neurostimulation is not yet fully embedded as part of their treatment pathway. As a company that prioritizes 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 pulling patients first. We are ready to launch in The US with 50 commercial team members who are all hired and trained. Olivier TaelmanCEO & Executive Director at Nyxoah00:06:25This team is comprised of sales, marketing, market access professionals who will be supported by focused direct to consumer on DTC initiatives and dedicated reimbursement support. We plan to scale up 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 GENEWILS system and the clinical impact it can have on the OSA patient population. Olivier TaelmanCEO & Executive Director at Nyxoah00:07:08We 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 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:07:53We look forward to launching Xenu in The US 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 Laundry for the financial update. John LandryCFO at Nyxoah00:08:16Thank 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 of 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 two point one 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. John LandryCFO at Nyxoah00:08:49Total operating loss for the first quarter of twenty twenty five was EUR20.6 million versus EUR12.2 million in the first quarter of 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? Olivier TaelmanCEO & Executive Director at Nyxoah00:09:20Thank you, John. What sets Nixo 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 Genius system with patient comfort and convenience as priorities. Olivier TaelmanCEO & Executive Director at Nyxoah00:09:40No implanted battery, bilateral stimulation for consistent therapy regardless of patient sleep position and the 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 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:10:30The 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 Ixora'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. Operator00:11:29Our first question comes from the line of Jon Block from Stifel. Jonathan BlockManaging Director at Stifel Financial Corp00:11:34Thanks, guys. Good morning. Olivier, can you talk about what needs to get done at this US inspection versus the initial one that took place, you know, it earlier in the FDA process? Olivier TaelmanCEO & Executive Director at Nyxoah00:11:50Yes. 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 US. You start by doing this administrative and also show protocols and how you validate certain processes that have been done, submitted and accepted by FDA. Olivier TaelmanCEO & Executive Director at Nyxoah00:12:14So 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. Jonathan BlockManaging Director at Stifel Financial Corp00:12:28Okay. I think I got that. Just one follow-up to my first question for clarification. When you see the physical site inspection is ongoing, has that again, it's a physical site inspection. So has that occurred? Jonathan BlockManaging Director at Stifel Financial Corp00:12:43Have 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:12:54Yes. So definitely. So the site inspection is actively taking place as we speak. Normal process of the site inspection is that it can last up to five days. We don't know. Olivier TaelmanCEO & Executive Director at Nyxoah00:13:04It'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 cohort two. Jonathan BlockManaging Director at Stifel Financial Corp00:13:25Okay, 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, 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 possible. Can you talk about the outreach on one versus the other and how the company will tackle that? Thank you. Olivier TaelmanCEO & Executive Director at Nyxoah00:14:17Yes, 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, GENIOR was designed with the patient focus and centric in mind. So that is one aspect of this. Olivier TaelmanCEO & Executive Director at Nyxoah00:14:32And 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. Very concrete, we are the only company that can offer clinical data in 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. 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 handed out with an approval. Olivier TaelmanCEO & Executive Director at Nyxoah00:15:15But it is clear that the discussions and the way we positioned the MELOC 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 OSA. And then your last part of the question was CCC patients. As you know, we already have CCC on label in all international markets. Olivier TaelmanCEO & Executive Director at Nyxoah00:15:39We are seeing great results in the markets where we are commercially available on CCC patients. We are conducting a specific study in The U. S. 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:15:57And to start with, CCC would not be reflected as a contraindication in the label that will be issued in going forward. But again, we will have to wait upon FDA approval to have the final confirmation of all this. Jonathan BlockManaging Director at Stifel Financial Corp00:16:12Understood. Thanks for the color, guys. Operator00:16:16Thank you. One moment for our next question. Our next question comes from the line of Adam Meter from Piper Sandler. Adam MaederManaging Director & Senior Research Analyst at Piper Sandler Companies00:16:26Hi. 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. Adam MaederManaging Director & Senior Research Analyst at Piper Sandler Companies00:16:43My 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 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. Thanks. Olivier TaelmanCEO & Executive Director at Nyxoah00:17:03Yeah. 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:17:18And at that point, FDA has all the information needed to 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. I'm just highlighting again the steps that we are facing, that we are going through as we speak. Adam MaederManaging Director & Senior Research Analyst at Piper Sandler Companies00:17:39Okay. 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? Olivier TaelmanCEO & Executive Director at Nyxoah00:17:56Definitely. 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:18:12We 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, we should be able to have a publication out. Adam MaederManaging Director & Senior Research Analyst at Piper Sandler Companies00:18:23Okay. Fantastic. And just one more from me, if that's okay, and then I'll hop back in the queue. For 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 helpful. Thank you. John LandryCFO at Nyxoah00:18:46Sure. 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 cash runway as well into the second quarter of twenty twenty six. Adam MaederManaging Director & Senior Research Analyst at Piper Sandler Companies00:19:19Okay. 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 for spend going forward. Thanks. John LandryCFO at Nyxoah00:19:41Sure. 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, you know, 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, know, the first couple of quarters are probably going to be a little bit heavier than the back quarters of the year. Adam MaederManaging Director & Senior Research Analyst at Piper Sandler Companies00:20:19That's really good color. Appreciate it. Thank you. Olivier TaelmanCEO & Executive Director at Nyxoah00:20:21You're welcome, Adam. Operator00:20:23Thank you. One moment for our next question. Our next question comes from the line of Ross Osborne from Cantor Fitzgerald. Ross OsbornDirector, Lead Research Analyst - MedTech and Diagnostics at Cantor Fitzgerald00:20:34Hey guys, thanks for taking our questions. Starting off, would be curious to hear how the commercial launch of GEO 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? Olivier TaelmanCEO & Executive Director at Nyxoah00:20:53Yes. So thank you, Ross, 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:21:09We 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 AGN 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 first implanting in quarter two, quarter '3, and and and beyond. Ross OsbornDirector, Lead Research Analyst - MedTech and Diagnostics at Cantor Fitzgerald00:21:37Great. And then apologies if I missed this. Any update on the ACCESS study in terms of where you stand with implants? Olivier TaelmanCEO & Executive Director at Nyxoah00:21:45No. 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:22:02Once 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. Ross OsbornDirector, Lead Research Analyst - MedTech and Diagnostics at Cantor Fitzgerald00:22:14Great. Thanks for taking our questions. Operator00:22:18Thank you. One moment for our next question. Our next question comes from the line of Suraj Kalia from Oppenheimer and Company. Suraj KaliaManaging Director at Oppenheimer & Co. Inc.00:22:30Good morning, Olivier, John. Hey, Olivier. So, thank 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, you know, the 300 or so top at GNS 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. Suraj KaliaManaging Director at Oppenheimer & Co. Inc.00:23:05How 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? Olivier TaelmanCEO & Executive Director at Nyxoah00:23:25Yeah. No, Suraj. Nice to hear you, and thank you for for for the for the commercial question. If I can refer to this like this. So first of all, I would like to highlight that over one hundred thousand patients have received a GNS treatment. Olivier TaelmanCEO & Executive Director at Nyxoah00:23:40And 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 Gillio 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 part the the fact committees that when passing this we also start planning a lot of time and also scheduling real time patients. Olivier TaelmanCEO & Executive Director at Nyxoah00:24:23And once we are doing this we will make sure that we have products available at 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 order dates and you make sure you have your products available including some backups in case there would be a need Suraj KaliaManaging Director at Oppenheimer & Co. Inc.00:24:48Got it. Olivier TaelmanCEO & Executive Director at Nyxoah00:24:53Apologies for the background noise if you will hear this, but Suraj KaliaManaging Director at Oppenheimer & Co. Inc.00:24:56No. That's okay. I I was 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 or the second part of the question, Olivier, as you all roll out Genio commercially, what do you expect to do in terms of DTC? Suraj KaliaManaging Director at Oppenheimer & Co. Inc.00:25:23How are you all expecting to be different than Inspire? Thank you for taking my questions. Olivier TaelmanCEO & Executive Director at Nyxoah00:25:29Yes, definitely. So Suraj, we have been planning very carefully and studying The U. S. Market. It starts with heat maps. Olivier TaelmanCEO & Executive Director at Nyxoah00:25:37They 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 over to the entire AGNS market in The U. S. Olivier TaelmanCEO & Executive Director at Nyxoah00:25:53Using 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, I hope it will be different. We are different that we will not have Super Bowl commercials. I have to say something maybe a little bit funny, but we will not have this huge DTC outreach as known today by AGNS competitor. Olivier TaelmanCEO & Executive Director at Nyxoah00:26:15We 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 trend. Suraj KaliaManaging Director at Oppenheimer & Co. Inc.00:26:46Got it. Thank you. Operator00:26:48Thank you. One moment for our next question. Our next question comes from the line of David Ray Scott from Baird. David RescottSenior Research Analyst at Baird00:27:01Thanks for taking the questions. Olivia, I wanted to ask on JENEO two point one. I think you called out that in Europe with the rollout there of the 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 Jennie O 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, 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 step of yours? Olivier TaelmanCEO & Executive Director at Nyxoah00:27:49Yes. No, thank you for this question, David. And it's a very important one. And I will start and then John Will will definitely step in on the second part of this question of rollout and how do we further scale up. But as I mentioned in the beginning, it is so important for Nixoa to offer patient centric solutions. Olivier TaelmanCEO & Executive Director at Nyxoah00:28:07And the JYNNEO two point one 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, 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 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:28:56Now, 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 centric solution. Now, how do you hold 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. John LandryCFO at Nyxoah00:29:26Thank 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 the customers wanted 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 twenty twenty five versus first quarter of twenty twenty four. What we're looking to do in The U. S, we'll have our Geneo two point one available for all these customers. John LandryCFO at Nyxoah00:29:53So as we enter the market, we won't have a switch from the Geneo two point zero to the 2.1. So we'll be ready to roll from that perspective as we enter into The U. S. Market. David RescottSenior Research Analyst at Baird00:30:05Okay, thanks. Reimbursement front, you've been consistent on the coach 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 definitively 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 team to really help streamline pushing these patients through and getting coverage when you also enroll out in The U. S? Thank you. John LandryCFO at Nyxoah00:30:51Yeah, thanks for the question David. Yes, so short answer, we have a team, a 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 US. Olivier TaelmanCEO & Executive Director at Nyxoah00:31:32John? And maybe I just like to 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 in the 64,568 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:31:53So yes, we do feel confident that this barrier or disorder is also successfully taken and will result in a quick revenue generation. David RescottSenior Research Analyst at Baird00:32:03Okay. Thank you. Operator00:32:06Thank you. One moment for our next question. Our next question comes from the line of Michael Pollard from Wolfe Research. Mike PolarkSenior Equity Research Analyst - Medical Devices at Wolfe Research, LLC00:32:17Hey, good morning. 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? Olivier TaelmanCEO & Executive Director at Nyxoah00:32:50No, 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 have 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 implant it CCC patients. So that's I think I hope this is very clear. Olivier TaelmanCEO & Executive Director at Nyxoah00:33:15Second 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 Gneo 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 off 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:33:56I hope this is answering your question. Because I want to evaluate even this. Yes. Mike PolarkSenior Equity Research Analyst - Medical Devices at Wolfe Research, LLC00:34:00Thank you. And so related, 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 this labeling expectation for CCC? Olivier TaelmanCEO & Executive Director at Nyxoah00:34:15Yes. 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 dice. That is currently still the most by traditional and accepted measurements to exclude CCC. Olivier TaelmanCEO & Executive Director at Nyxoah00:34:38I also know and we also know that there is some worry 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 DRIEM, it is also obvious that we will have to exclude CCC and that we will not actively promote this when launching the product. Mike PolarkSenior Equity Research Analyst - Medical Devices at Wolfe Research, LLC00:35:03Thank you, Olivier. Olivier TaelmanCEO & Executive Director at Nyxoah00:35:05Thank you, Mike. Operator00:35:07Thank you. One moment for our next question. Our final question comes from the line of Laura Rova from Degroof Petercam. Laura RobaHealthcare & ESG Equity Analyst at Degroof Petercam00:35:20Good afternoon. Thank you for taking my question. Laura RobaHealthcare & ESG Equity Analyst at Degroof Petercam00:35:22First 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 and also your expectations going forward? Thank you. John LandryCFO at Nyxoah00:35:45Sure. 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 digits 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. John LandryCFO at Nyxoah00:36:07With 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 those are some of the nature of the items that we're deferring to extend the runway out. Laura RobaHealthcare & ESG Equity Analyst at Degroof Petercam00:36:51Okay. Thank you. Operator00:36:54Thank you. At this time, I would now like to turn the conference back over to Olivier Tauman, Chief Executive Officer for closing remarks. Olivier TaelmanCEO & Executive Director at Nyxoah00:37:05So 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 MiXOA'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 MiXOA and we are really looking forward to updating you on our progress in the coming weeksmonths on FDA to be very precise. Thank you all for joining. Operator00:37:32This concludes today's conference call. Thank you for participating. You may now disconnect.Read moreParticipantsExecutivesPearson DennisInvestor Relations AssociateOlivier TaelmanCEO & Executive DirectorJohn LandryCFOAnalystsJonathan BlockManaging Director at Stifel Financial CorpAdam MaederManaging Director & Senior Research Analyst at Piper Sandler CompaniesRoss OsbornDirector, Lead Research Analyst - MedTech and Diagnostics at Cantor FitzgeraldSuraj KaliaManaging Director at Oppenheimer & Co. Inc.David RescottSenior Research Analyst at BairdMike PolarkSenior Equity Research Analyst - Medical Devices at Wolfe Research, LLCLaura RobaHealthcare & ESG Equity Analyst at Degroof PetercamPowered by Key Takeaways The company has completed FDA-required process validation and is undergoing a final on-site inspection for its GENEOS system, and continues to expect PMA approval in Q2 2025. In preparation for its U.S. commercial launch, Nixoa has hired and trained a 50-member go-to-market team focused on high-volume hypoglossal nerve stimulation centers and sleep physicians. For reimbursement, the company will leverage the established CPT code 64568, working with CMS, major payers and the American Academy of Otolaryngology through the FDA’s early payer feedback program. First-quarter 2025 revenue was €1.1 million (down from €1.2 million) due to international market softness and the phased Genio 2.1 rollout, while operating loss widened to €20.6 million as U.S. commercial investments ramped and cash stood at €63 million. GENEOS differentiation highlights include no implanted battery, bilateral stimulation, single-incision procedure and unique clinical data on supine and positional OSA, with software upgrades designed to improve patient comfort and autonomy. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallNyxoah Q1 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipants Earnings DocumentsPress Release(8-K) Nyxoah Earnings HeadlinesNyxoah to Present at the Jefferies Global Healthcare ConferenceMay 28, 2025 | globenewswire.comKepler Capital Reaffirms Their Buy Rating on Nyxoah (NYXH)May 24, 2025 | theglobeandmail.comBanks aren’t ready for this altcoin—are you?While everyone's distracted by Bitcoin's moves, a stealth revolution is underway. One altcoin is quietly positioning itself to overthrow the entire banking system.June 6, 2025 | Crypto 101 Media (Ad)INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Nyxoah S.A. - NYXHMay 18, 2025 | gurufocus.comNyxoah outlines U.S. Genio launch plan with 50-member team as FDA approval expected Q2 2025May 16, 2025 | seekingalpha.comNyxoah S.A. (NASDAQ:NYXH) Q1 2025 Earnings Call TranscriptMay 15, 2025 | msn.comSee More Nyxoah Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Nyxoah? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Nyxoah and other key companies, straight to your email. Email Address About NyxoahNyxoah (NASDAQ:NYXH), a medical technology company, focuses on the development and commercialization of solutions to treat sleep disordered breathing conditions. The company's lead solution comprises Genio system, a CE-Marked, patient-centric, and hypoglossal neurostimulation therapy to treat moderate to severe obstructive sleep apnea. Nyxoah S.A. was incorporated in 2009 and is headquartered in Mont-Saint-Guibert, Belgium.View Nyxoah ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Red Robin's Comeback: Q1 Earnings Spark Investor HopesOllie’s Q1 Earnings: The Good, the Bad, and What’s NextBroadcom Earnings Preview: AVGO Stock Near Record HighsUlta’s Beautiful Q1 Earnings Report Points to More Gains Aheade.l.f. Beauty Sees Record Surge After Earnings, Rhode DealCrowdStrike Stock Slips: Analyst Downgrades Before Earnings Bullish NVIDIA Market Set to Surge 50% Ahead of Q1 Earnings Upcoming Earnings Haleon (6/11/2025)Oracle (6/11/2025)Adobe (6/12/2025)Accenture (6/20/2025)FedEx (6/24/2025)Micron Technology (6/25/2025)Paychex (6/25/2025)NIKE (6/26/2025)PepsiCo (7/10/2025)Bank of America (7/14/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
PresentationSkip to Participants Operator00:00:00Good day and thank you for standing by. Welcome to the Nixoa First Quarter twenty twenty five 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. Please be advised that today's conference is being recorded. Operator00:00:33I would now like to hand the conference over to your speaker today, Pearson Dennis, Investor Relations Associate. Please go ahead. Pearson DennisInvestor Relations Associate at Nyxoah00:00:42Thank you. 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. Pearson DennisInvestor Relations Associate at Nyxoah00:01:05Market 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. Pearson DennisInvestor Relations Associate at Nyxoah00:01:38These 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 03/20/2025. With that, I will now turn the call over to Olivier. Olivier TaelmanCEO & Executive Director at Nyxoah00:02:22Thank 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 Bersen 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 approval letter for our GENEOS system, which confirms that our application substantially meets the requirements for marketing in The US. Olivier TaelmanCEO & Executive Director at Nyxoah00:02:56Importantly, the FDA accepted our biocompatibility testing, 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, the 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 US 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:03:46As 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 we continue to expect to receive PMA approval in the second quarter of twenty twenty five. In preparation of our U. S. Olivier TaelmanCEO & Executive Director at Nyxoah00:04:20Commercial 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:04:43Our 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 confirmed 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:05:18Research 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 GENEEL technology giving their participation in our clinical trials and usability studies and became familiar with the Genius 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 neurostimulation is not yet fully embedded as part of their treatment pathway. As a company that prioritizes 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 pulling patients first. We are ready to launch in The US with 50 commercial team members who are all hired and trained. Olivier TaelmanCEO & Executive Director at Nyxoah00:06:25This team is comprised of sales, marketing, market access professionals who will be supported by focused direct to consumer on DTC initiatives and dedicated reimbursement support. We plan to scale up 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 GENEWILS system and the clinical impact it can have on the OSA patient population. Olivier TaelmanCEO & Executive Director at Nyxoah00:07:08We 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 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:07:53We look forward to launching Xenu in The US 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 Laundry for the financial update. John LandryCFO at Nyxoah00:08:16Thank 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 of 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 two point one 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. John LandryCFO at Nyxoah00:08:49Total operating loss for the first quarter of twenty twenty five was EUR20.6 million versus EUR12.2 million in the first quarter of 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? Olivier TaelmanCEO & Executive Director at Nyxoah00:09:20Thank you, John. What sets Nixo 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 Genius system with patient comfort and convenience as priorities. Olivier TaelmanCEO & Executive Director at Nyxoah00:09:40No implanted battery, bilateral stimulation for consistent therapy regardless of patient sleep position and the 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 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:10:30The 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 Ixora'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. Operator00:11:29Our first question comes from the line of Jon Block from Stifel. Jonathan BlockManaging Director at Stifel Financial Corp00:11:34Thanks, guys. Good morning. Olivier, can you talk about what needs to get done at this US inspection versus the initial one that took place, you know, it earlier in the FDA process? Olivier TaelmanCEO & Executive Director at Nyxoah00:11:50Yes. 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 US. You start by doing this administrative and also show protocols and how you validate certain processes that have been done, submitted and accepted by FDA. Olivier TaelmanCEO & Executive Director at Nyxoah00:12:14So 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. Jonathan BlockManaging Director at Stifel Financial Corp00:12:28Okay. I think I got that. Just one follow-up to my first question for clarification. When you see the physical site inspection is ongoing, has that again, it's a physical site inspection. So has that occurred? Jonathan BlockManaging Director at Stifel Financial Corp00:12:43Have 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:12:54Yes. So definitely. So the site inspection is actively taking place as we speak. Normal process of the site inspection is that it can last up to five days. We don't know. Olivier TaelmanCEO & Executive Director at Nyxoah00:13:04It'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 cohort two. Jonathan BlockManaging Director at Stifel Financial Corp00:13:25Okay, 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, 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 possible. Can you talk about the outreach on one versus the other and how the company will tackle that? Thank you. Olivier TaelmanCEO & Executive Director at Nyxoah00:14:17Yes, 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, GENIOR was designed with the patient focus and centric in mind. So that is one aspect of this. Olivier TaelmanCEO & Executive Director at Nyxoah00:14:32And 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. Very concrete, we are the only company that can offer clinical data in 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. 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 handed out with an approval. Olivier TaelmanCEO & Executive Director at Nyxoah00:15:15But it is clear that the discussions and the way we positioned the MELOC 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 OSA. And then your last part of the question was CCC patients. As you know, we already have CCC on label in all international markets. Olivier TaelmanCEO & Executive Director at Nyxoah00:15:39We are seeing great results in the markets where we are commercially available on CCC patients. We are conducting a specific study in The U. S. 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:15:57And to start with, CCC would not be reflected as a contraindication in the label that will be issued in going forward. But again, we will have to wait upon FDA approval to have the final confirmation of all this. Jonathan BlockManaging Director at Stifel Financial Corp00:16:12Understood. Thanks for the color, guys. Operator00:16:16Thank you. One moment for our next question. Our next question comes from the line of Adam Meter from Piper Sandler. Adam MaederManaging Director & Senior Research Analyst at Piper Sandler Companies00:16:26Hi. 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. Adam MaederManaging Director & Senior Research Analyst at Piper Sandler Companies00:16:43My 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 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. Thanks. Olivier TaelmanCEO & Executive Director at Nyxoah00:17:03Yeah. 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:17:18And at that point, FDA has all the information needed to 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. I'm just highlighting again the steps that we are facing, that we are going through as we speak. Adam MaederManaging Director & Senior Research Analyst at Piper Sandler Companies00:17:39Okay. 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? Olivier TaelmanCEO & Executive Director at Nyxoah00:17:56Definitely. 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:18:12We 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, we should be able to have a publication out. Adam MaederManaging Director & Senior Research Analyst at Piper Sandler Companies00:18:23Okay. Fantastic. And just one more from me, if that's okay, and then I'll hop back in the queue. For 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 helpful. Thank you. John LandryCFO at Nyxoah00:18:46Sure. 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 cash runway as well into the second quarter of twenty twenty six. Adam MaederManaging Director & Senior Research Analyst at Piper Sandler Companies00:19:19Okay. 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 for spend going forward. Thanks. John LandryCFO at Nyxoah00:19:41Sure. 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, you know, 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, know, the first couple of quarters are probably going to be a little bit heavier than the back quarters of the year. Adam MaederManaging Director & Senior Research Analyst at Piper Sandler Companies00:20:19That's really good color. Appreciate it. Thank you. Olivier TaelmanCEO & Executive Director at Nyxoah00:20:21You're welcome, Adam. Operator00:20:23Thank you. One moment for our next question. Our next question comes from the line of Ross Osborne from Cantor Fitzgerald. Ross OsbornDirector, Lead Research Analyst - MedTech and Diagnostics at Cantor Fitzgerald00:20:34Hey guys, thanks for taking our questions. Starting off, would be curious to hear how the commercial launch of GEO 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? Olivier TaelmanCEO & Executive Director at Nyxoah00:20:53Yes. So thank you, Ross, 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:21:09We 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 AGN 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 first implanting in quarter two, quarter '3, and and and beyond. Ross OsbornDirector, Lead Research Analyst - MedTech and Diagnostics at Cantor Fitzgerald00:21:37Great. And then apologies if I missed this. Any update on the ACCESS study in terms of where you stand with implants? Olivier TaelmanCEO & Executive Director at Nyxoah00:21:45No. 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:22:02Once 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. Ross OsbornDirector, Lead Research Analyst - MedTech and Diagnostics at Cantor Fitzgerald00:22:14Great. Thanks for taking our questions. Operator00:22:18Thank you. One moment for our next question. Our next question comes from the line of Suraj Kalia from Oppenheimer and Company. Suraj KaliaManaging Director at Oppenheimer & Co. Inc.00:22:30Good morning, Olivier, John. Hey, Olivier. So, thank 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, you know, the 300 or so top at GNS 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. Suraj KaliaManaging Director at Oppenheimer & Co. Inc.00:23:05How 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? Olivier TaelmanCEO & Executive Director at Nyxoah00:23:25Yeah. No, Suraj. Nice to hear you, and thank you for for for the for the commercial question. If I can refer to this like this. So first of all, I would like to highlight that over one hundred thousand patients have received a GNS treatment. Olivier TaelmanCEO & Executive Director at Nyxoah00:23:40And 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 Gillio 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 part the the fact committees that when passing this we also start planning a lot of time and also scheduling real time patients. Olivier TaelmanCEO & Executive Director at Nyxoah00:24:23And once we are doing this we will make sure that we have products available at 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 order dates and you make sure you have your products available including some backups in case there would be a need Suraj KaliaManaging Director at Oppenheimer & Co. Inc.00:24:48Got it. Olivier TaelmanCEO & Executive Director at Nyxoah00:24:53Apologies for the background noise if you will hear this, but Suraj KaliaManaging Director at Oppenheimer & Co. Inc.00:24:56No. That's okay. I I was 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 or the second part of the question, Olivier, as you all roll out Genio commercially, what do you expect to do in terms of DTC? Suraj KaliaManaging Director at Oppenheimer & Co. Inc.00:25:23How are you all expecting to be different than Inspire? Thank you for taking my questions. Olivier TaelmanCEO & Executive Director at Nyxoah00:25:29Yes, definitely. So Suraj, we have been planning very carefully and studying The U. S. Market. It starts with heat maps. Olivier TaelmanCEO & Executive Director at Nyxoah00:25:37They 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 over to the entire AGNS market in The U. S. Olivier TaelmanCEO & Executive Director at Nyxoah00:25:53Using 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, I hope it will be different. We are different that we will not have Super Bowl commercials. I have to say something maybe a little bit funny, but we will not have this huge DTC outreach as known today by AGNS competitor. Olivier TaelmanCEO & Executive Director at Nyxoah00:26:15We 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 trend. Suraj KaliaManaging Director at Oppenheimer & Co. Inc.00:26:46Got it. Thank you. Operator00:26:48Thank you. One moment for our next question. Our next question comes from the line of David Ray Scott from Baird. David RescottSenior Research Analyst at Baird00:27:01Thanks for taking the questions. Olivia, I wanted to ask on JENEO two point one. I think you called out that in Europe with the rollout there of the 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 Jennie O 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, 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 step of yours? Olivier TaelmanCEO & Executive Director at Nyxoah00:27:49Yes. No, thank you for this question, David. And it's a very important one. And I will start and then John Will will definitely step in on the second part of this question of rollout and how do we further scale up. But as I mentioned in the beginning, it is so important for Nixoa to offer patient centric solutions. Olivier TaelmanCEO & Executive Director at Nyxoah00:28:07And the JYNNEO two point one 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, 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 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:28:56Now, 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 centric solution. Now, how do you hold 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. John LandryCFO at Nyxoah00:29:26Thank 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 the customers wanted 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 twenty twenty five versus first quarter of twenty twenty four. What we're looking to do in The U. S, we'll have our Geneo two point one available for all these customers. John LandryCFO at Nyxoah00:29:53So as we enter the market, we won't have a switch from the Geneo two point zero to the 2.1. So we'll be ready to roll from that perspective as we enter into The U. S. Market. David RescottSenior Research Analyst at Baird00:30:05Okay, thanks. Reimbursement front, you've been consistent on the coach 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 definitively 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 team to really help streamline pushing these patients through and getting coverage when you also enroll out in The U. S? Thank you. John LandryCFO at Nyxoah00:30:51Yeah, thanks for the question David. Yes, so short answer, we have a team, a 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 US. Olivier TaelmanCEO & Executive Director at Nyxoah00:31:32John? And maybe I just like to 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 in the 64,568 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:31:53So yes, we do feel confident that this barrier or disorder is also successfully taken and will result in a quick revenue generation. David RescottSenior Research Analyst at Baird00:32:03Okay. Thank you. Operator00:32:06Thank you. One moment for our next question. Our next question comes from the line of Michael Pollard from Wolfe Research. Mike PolarkSenior Equity Research Analyst - Medical Devices at Wolfe Research, LLC00:32:17Hey, good morning. 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? Olivier TaelmanCEO & Executive Director at Nyxoah00:32:50No, 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 have 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 implant it CCC patients. So that's I think I hope this is very clear. Olivier TaelmanCEO & Executive Director at Nyxoah00:33:15Second 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 Gneo 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 off 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. Olivier TaelmanCEO & Executive Director at Nyxoah00:33:56I hope this is answering your question. Because I want to evaluate even this. Yes. Mike PolarkSenior Equity Research Analyst - Medical Devices at Wolfe Research, LLC00:34:00Thank you. And so related, 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 this labeling expectation for CCC? Olivier TaelmanCEO & Executive Director at Nyxoah00:34:15Yes. 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 dice. That is currently still the most by traditional and accepted measurements to exclude CCC. Olivier TaelmanCEO & Executive Director at Nyxoah00:34:38I also know and we also know that there is some worry 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 DRIEM, it is also obvious that we will have to exclude CCC and that we will not actively promote this when launching the product. Mike PolarkSenior Equity Research Analyst - Medical Devices at Wolfe Research, LLC00:35:03Thank you, Olivier. Olivier TaelmanCEO & Executive Director at Nyxoah00:35:05Thank you, Mike. Operator00:35:07Thank you. One moment for our next question. Our final question comes from the line of Laura Rova from Degroof Petercam. Laura RobaHealthcare & ESG Equity Analyst at Degroof Petercam00:35:20Good afternoon. Thank you for taking my question. Laura RobaHealthcare & ESG Equity Analyst at Degroof Petercam00:35:22First 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 and also your expectations going forward? Thank you. John LandryCFO at Nyxoah00:35:45Sure. 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 digits 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. John LandryCFO at Nyxoah00:36:07With 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 those are some of the nature of the items that we're deferring to extend the runway out. Laura RobaHealthcare & ESG Equity Analyst at Degroof Petercam00:36:51Okay. Thank you. Operator00:36:54Thank you. At this time, I would now like to turn the conference back over to Olivier Tauman, Chief Executive Officer for closing remarks. Olivier TaelmanCEO & Executive Director at Nyxoah00:37:05So 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 MiXOA'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 MiXOA and we are really looking forward to updating you on our progress in the coming weeksmonths on FDA to be very precise. Thank you all for joining. Operator00:37:32This concludes today's conference call. Thank you for participating. You may now disconnect.Read moreParticipantsExecutivesPearson DennisInvestor Relations AssociateOlivier TaelmanCEO & Executive DirectorJohn LandryCFOAnalystsJonathan BlockManaging Director at Stifel Financial CorpAdam MaederManaging Director & Senior Research Analyst at Piper Sandler CompaniesRoss OsbornDirector, Lead Research Analyst - MedTech and Diagnostics at Cantor FitzgeraldSuraj KaliaManaging Director at Oppenheimer & Co. Inc.David RescottSenior Research Analyst at BairdMike PolarkSenior Equity Research Analyst - Medical Devices at Wolfe Research, LLCLaura RobaHealthcare & ESG Equity Analyst at Degroof PetercamPowered by