Nyxoah SA ($NYXH)

I'm on the medtech team here at Bank of America. Really happy to introduce our next presenter, Nyxoah. We have CEO, Olivier Taelman, to present.

Good afternoon, everyone. First of all, thank you, and thank you, Bank of America, for having us and to be able to explain a little bit and talk a little bit more about the Nyxoah story. When we talk about Nyxoah, we are talking about obstructive sleep apnea and the treatment of obstructive sleep apnea by offering a neuromodulation solution. Before I dig in a little bit further into our technology, I would like to talk a little bit more about the market space. I think everyone is familiar with someone who is struggling from sleep apnea wearing a CPAP mask. It is a huge market in the U.S. It's a huge market globally. But when we focus on the U.S., we are talking about a $10 billion market opportunity or roughly 500,000 patients that are annually eligible for treatment because they suffer from moderate to severe obstructive sleep apnea. What we offer as Nyxoah? We offer a totally differentiated and unique neuromodulation solution. And I will be walking you through this in a couple of slides and showing also the technology. We have compelling clinical evidence that resulted in FDA approval. We obtained FDA approval last year in August, and we are currently actively launching. Yesterday, in fact, I did the earnings call for our Q1 results now 6 months post FDA approval. In the meantime, we treated over 1,200 patients in Europe to be very precise and the longest implanted patient with our Genio technology is already more than 7 years benefiting from the technology and as I was mentioning, I think the most exciting point that we are currently going through in the stage of company is that we fully transitioned from a clinical stage company into a commercial stage company in the U.S., but also in other countries around the globe. Now before I continue and go a little bit more in depth on the technology as such. I make it like a case of honor to start by saying why are people in need for treatment when you suffer from obstructive sleep apnea. And to make a long story short, every time when you go to bed and you start sleeping, you will have an airway obstruction that can be 15, 20, 30, 40 times every hour, and that is causing a lack of oxygen to your vital organs. So what you see is when you are not treated for your obstructive sleep apnea, that the risk for comorbidity significantly increases, the risk of cardiovascular incidents go up by 5, the risk of heart failure almost triples and the risk of stroke doubles. There is also a clear link with a high prevalency in other key chronic diseases. I'd like to point out diabetes type 2 because we're also seeing that this is a fast-growing business in the current society globally. And there, we already know that 72% of all type 2 diabetes patients are also suffering from obstructive sleep apnea. When you look at obstructive sleep apnea, there is clearly a graduation linked to the severity. If you have 15 or more obstructions every hour, you are a moderate obstructive sleep apnea patient and you are in need for medical treatment. If you have more than 30 obstructions every hour, you become a severe patient and you definitely are in need for treatment. Sometimes, and it's a little anecdote, people are always talking. Will this also help against the snoring? The answer is yes, because every obstructive sleep apnea is snoring, but it's not because you snore occasionally that you suffer from obstructive sleep apnea. The treatment options, as I mentioned before, the golden standard still is the CPAP mask. Besides the CPAP mask, there are also mandibular advancement devices, mainly prescribed by a dentist. What we are seeing is that they are more focusing on soft or less than moderate obstructive sleep apnea and also from a clinical evidence perspective, they are not so backed up. It's also highly costly. It's all out-of-pocket pay and for those who can benefit from them, the better. But it's not the kind of treatment option that you use if you're suffering from moderate to severe OSA. There was traditional surgery. It's highly painful. We're also seeing that success rate is relatively low. And we see also that it's more something that is done with the old generation of ENT surgeons and that with the younger generation is no longer part of their treatment palette. Now when we dig in a little bit deeper to Genio and our solution, I was talking about a totally differentiated solution. So we have 2 components. There is 1 implantable aspect, the implantable stimulator as you can see on the bottom right, it's a passive device. There is no battery implanted. And it has 2 pedal electrodes. Why 2? Because if you look at the hypoglossal nerve, it also splits in 2 branches. And we are the only company with a technology that is stimulating both branches. Now why is this important? Two reasons. One, it will give you a strong therapeutic effect. And second, it also will consume less energy. And why is this so important? Because when a patient is sleeping, the last thing you want to do is wake the patient up by stimulating too strong or too intense. When you have a bilateral stimulation, you get the same strong effect with less stimulation needs from electric pulses. Because it's a passive device, it also automatically generates a full body MRI compatibility. As I touched earlier, a lot of the people are having other comorbidity factors. So it's also important that you know when you're implanted, you never need to worry when there is an MRI scan that is needed. Now going to the second part, it's the external or the smart wearable component. As you can see, the gentleman in the drawing is wearing this under the chin. So it's a very small wearable component that is containing 2 things: battery and through induction, it will activate the passive implant and it also contains software. Now, we call it smart because it understands what kind of stimulation it needs to send through to have an effect on the airway opening of the patient. And also by having an external battery, there is no need for repetitive surgery replacing a pacemaker that could be depleted. There is also no need for repetitive surgery when there is a software upgrade, we simply push it through like people are used to with their smartphone. In the morning, when you wake up, you just open the app on your phone and you get a lot of information on your sleep quality. And we also learned that this is something that is highly valued by patients because it gives them not only more comfort, but it also give them a kind of involvement and a kind of power of their technology and seeing that their sleep quality is increasing. As a medtech device with an implantable component, it's clear, everything starts with robust clinical evidence. I will not go too much in depth on this one, but I would like to highlight 2 aspects. One, there is the effectiveness of your technology. So we reach our primary and secondary endpoints, expressed in an index, the hypopnea index and oxygen desaturation index. So we met all our primary endpoints. And then the next aspect important for physicians and patients is, is it a safe technology when you implant and also there with 8.7% severe adverse event rate, it brings us and makes us one of the lowest or one of the technologies with the highest safety profile that you can find in neuromodulation. Important, once you are implanted is that we see that 82% of all patients implanted with Genio, we are able to reduce their AHI below 15. As I mentioned before, 15 is the cutoff point for the need for surgical treatment. If you are below 15, your risk of cardiovascular stroke et cetera, is identical to people who are not suffering from OSA. So 82% of all our patients implanted or having an AHI that is being reduced below 15 and bringing them back to normal standards. Commercialization. And I was mentioning FDA approval, the U.S. is the largest market for obstructive sleep apnea. So it has been our goal from the beginning to enter this market and to try to be successful. If you look at our commercialization strategy, we are using a so-called smart follower strategy. On one hand, we focus on where the patients are, and they are in high-volume hypoglossal nerve stimulation center with ENT surgeons that are very familiar also with our competitive or with competitive technology. That's where we go with our sales force, position our technology as a totally differentiated technology and then also go after patients that are showing up and being referred by sleep medicine. It brings me to the second part of the strategy. We will immediately from the beginning, also try to partner a sleep doctor with the ENT surgeon colleague so that when it comes to patient phenotyping identification, the sleep physicians, they have a crucial role because they are also the CPAP prescribers. And then once the surgery is done, we also make sure that they stay involved also in managing, in fact, the implanted patient with their technology. So that's how we launch in the U.S. We learned that in the U.S., you have roughly 400 implant sites that are generating 70% of the total volume in hypoglossal nerve stim. So it's a very concentrated. The 400 accounts, they are generating, if I would put some dollar amounts behind more or less $600 million to $700 million on annual basis. I have a team, commercial team in the U.S. of 60 dedicated people. 40 of them are the sales reps, then we have roughly 10, 15 field engineers. There is some marketing, market access people and there are also some clinical and training education people. Reimbursement-wise, has been a hot topic lately in hypoglossal nerve space. I think finally, there is clarity. And I'm also extremely pleased that we were not directly impacted with all the changes and the unclarity that was taking place. Let us look at some results and some numbers. So 6 months post launch, we were able to train in the U.S. 207 surgeons with our Genio system coming out of 125 high-volume sites. We had 62 surgeons trained in Q1, just to give you an indication, how fast it's growing and how fast the uptake is. We have currently 91 active sites, all of the 125 high volume sites we targeted. 34 new accounts were activated in Q1. What do we mean with an active account? There are 2 parameters, the surgeon needs to be trained and also the value analysis committees need to give them their approval, there need to be a price in place so that we can do business. Once all this is in place, we can start recruiting patients. And exiting the first quarter, next to the implants we did, we have 241 patients lined up with a full prior authorization file submitted to a commercial payer that will be implanted in the quarter going forward. We also invested in some more feet on the street. We hired 15 more sales reps so that in total, we have now 40 people that can cover all of the 400 high-volume accounts. From a finance perspective, in Q1, we generated EUR 6.4 million. Apologies, I have to talk in euros, but we are still at headquartered in Belgium, and that's why we use the euro amount still today when we report our finance. You can see it was a nice growth, 13% global growth versus Q4 knowing that Q4 always is followed by Q1, where you see a lot of seasonality, 13% growth was a very strong result. But I think what was even more stronger and everyone is looking for is, how is the U.S. growing. And there, we generated EUR 4.3 million of showing a 25% growth over Q4. So if you combine everything, we can speak about a successful first 6 months. And we know that there were a lot of more patients that are lined up to be implanted. So the next quarters will be -- continue to be strong. We gave guidance up to 30% growth versus Q1 in the second quarter. Our cash and our balance sheet, we are still EUR 26 million on the balance sheet. We will draw down a loan from the European Investment Bank of another EUR 13.8 million. If you look at the guidance, I was already referring to this, we are giving 25% to 30% guidance for the second quarter in the U.S. over the first quarter. If you look at the annual revenue target first year of launch, we are forecasting to be between EUR 36 million to EUR 40 million. And I do think that is a strong uptake in the first year of launch in the medtech company, gross margin 60% to 62%. They will further increase to 80% when volume also will start increasing and our total operating expenses will be between EUR 97 million to EUR 99 million. Briefly, international markets, and I will not bother you too long with this, but I just would like to share that we did our first commercial efforts in Germany. And Germany was not incidentally picked. We went there because competition was there as well, and we did a commercial proof of concept. What have we learned? We learned 3 things: one, that when we entered first year, we were able to take 20% market share. Second thing we learned in this that when we went into the second year of launch with our referral strategy, the market share increased to 25%. And the last thing we learned in this in 3 years, we were able to go from launch all the way to profitability in 3 years already. I think my time is also up. So this is the last slide. What can you expect from us going forward? We will selectively invest in innovative leadership. So we're talking about smart wearables and intuitive apps. We are working on a cloud-based solution and telemedicine and of course, since we are increasing volume and we are capturing all data, we also will incorporate AI tools to make sure we can learn and we can learn fast. With this, I would like to thank you. I will not go too much over time. And once again, I hope it was interesting listening to this. And if you have someone who is suffering from the obstructive sleep apnea, you know where to find us. Thank you.