Nyxoah SA

Thank you for standing by and welcome to the NICSOA First Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Mr. Jeremy Pfeffer. Thank you. Please go ahead, sir.

Thank you, Justin. Good afternoon, everyone, and welcome to our earnings call for the first quarter of 2022. Participating from the company will be Olivier Tellman, Chief Executive Officer, and Loic Moreau, Chief Financial Officer. During the call, we will discuss our operating activities and review our first quarter financial results released after U.S. markets closed on May 9, 2022, after which we will host a question and answer session. The press release can be found on the investor relations section of our website. And this call is being recorded and will be archived in the events section of our investor relations website. Before we begin, I would like to remind you that any statements that relate to expectations or predictions of future events, market trends, results, or performance are forward-looking statements. All forward-looking statements are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. All forward-looking statements are based upon current available information, and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the risk factors section of our Form 20-F, followed with the Securities and Exchange Commission on March 24, 2022. With that, I will now turn the call over to Olivier.

Thank you, Jeremy. Good morning and good afternoon, everyone, and thank you for joining us for our first ever quarterly earning call. We are excited to move to a quarterly earning call schedule and give more frequent updates. And I'm especially happy to share our first quarterly results as we made very strong progress towards achieving the key strategic objectives for 2022 that we laid out in our prior call. Allow me to quickly remind you of these key objectives. Completing the dream trial implant in the second quarter of 2022, accelerating commercial execution in Germany, and commencing a US IDE study for complete concentric lab patients in the fourth quarter of 2022. I first would like to acknowledge our dedicated team for their strong execution, resulting in an acceleration during Q1 on all our strategic priorities. Our Q1 call was mainly focused on dream enrollment acceleration and the rapid growth we saw in our European sales. Starting with our commercial performance in Germany, I'm proud to report that sales growth accelerated significantly during the quarter. We generated €660,000 in the first quarter of 2022. which represents year-over-year growth of more than three and a half times and more than double what we achieved during Q4, the previous quarter, in 2021. Knowing the Omicron variant was still impacting procedures across Europe during January through roughly mid-February, our overall strong Q1 performance underscores the execution focus by our commercial team. Even more powerful in our view is the impact we are having in the German market. As a reminder, our commercial proof of concept will be to become market leader in Germany by the end of 2022. Our first quarter performance also exemplifies what we mean by our going deep commercial strategy of targeting and developing center of excellence. Exiting Q1, we had 15 active implant sites in Germany. a 25% growth over Q4 2021. And we expect to add an extra 10 accounts by the end of Q3, bringing the total to 25 active German implanting accounts. Looking at our Q1 revenue, we estimate based on our knowledge of the German market, we achieved approximately 25% market share in Germany in the quarter. which is more than double our market share compared to the previous quarter. For the quarter to come, we expect to further accelerate the revenue ramp by increasing therapy penetration in the existing sites, opening more centers of excellence, and further strengthening our relations with implanting EMT surgeons and referring sleep physicians. Additionally, we expect to see the first result from our direct-to-patients effort and we will continue putting the patients first, highlighted by having the only hypo-glossal nerve stimulation therapy with a full-body 3.0 MRI compatibility. We have also experienced strong tailwinds as a result of the positive better sleep data on complete concentric collapse and non-CCC patients that we presented in March during the World Sleep Congress in Rome. This event gave us an invaluable opportunity to interact with 55 international KOLs during an exclusive event we hosted in parallel to the Congress. Among the most important takeaways from WorldSleep was how many physicians expressed excitement that they now had an option to treat their complete concentric collapse patient, whom they previously had to turn away. to have implanted our first complete concentric collapse, or CCC, patients during the quarter after receiving an expansion of our CE mark indication. Based on the positive response we have received from physicians, both during and after well sleep, we expect increasing numbers of CCC patients implanted in the coming quarter. Taking all of these data points together, we remain confident that we can achieve market leadership status in Germany by the end of 2022. Next to Germany, we also made meaningful progress in other key European markets. Based on our existing DRG code in Switzerland, we secured additional Swiss accounts ready for their first commercial implant to be expected during Q2, and are progressing with reimbursement discussions in the Netherlands, Belgium and Finland. We have initiated discussions in the UK and we continue to assess opportunities in France and the Nordic countries. While we are not providing revenue guidance of 2022, we are extremely pleased with our first quarter performance and expect to see revenue totals ramping up further each quarter this year. Let me now talk a little bit more about the DREAM Pivotal Study in the US. For those who are new, the DREAM trial is our pivotal IDE study in the US. Let me first walk you through our process on patient enrollment and the funnel that leads from initial enrollment all the way to implantation. As of today, we have enrolled 503 patients, of whom 66 made it through the funnel to implantation. Another 20 have passed their baseline PSG and are awaiting implantation. There are an additional 86 patients in active screening, and we accept that 60 to 70% of these will make it to implantation. As a result, we believe we have enough patients enrolled to complete the study. Our priority now is to move these patients through the last steps of the process in a timely manner. We therefore expect to further accelerate our pace of implants. For reference, In the weeks since our last earning call, we have averaged approximately four implants per week. But we have seen that the rate accelerated over the last two weeks to six implants per week. Based on OR backlogs having been largely cleared, recently opened centers increasing their rate of implants and adding private sleep labs, which have excess capacity, we remain confident that the implant pays will remain at this level and might even accelerate further, and that we will achieve our target of implant completion by the end of this quarter. For those of you who saw this in our earning call press release, I am pleased to announce that based on new and favorable data from the Better Sleep Study, the FDA has approved our request to reduce the Dream Study sample size. We are therefore now required to implant 115 patients versus the original 134. Aside from the updated sample size, all other study parameters, including performance goals, statistical power, and significance level, remain identical to the original approved study. The implication for us is that 19 fewer patients need to be implanted, which further strengthens our confidence in closing implants by the end of June. As for CCC, we continue our dialogue with FDA regarding our IDE submission for the ACCESS trial, and we still expect to implant the first patient before the end of the year. As part of the breakthrough device designation process, we had our initial sprint discussion with FDA, and we are now incorporating their feedback in our IDE submission preparation. We will provide more details about sample size, design, endpoint, and timeline once we secure IDE approval, which we anticipate occurring this summer. I'm also extremely pleased to announce that we have nominated two outstanding individuals for appointment to our Board of Directors Spending Approval at our annual shareholder meeting on June 8. They are Raymond Cohen, Chief Executive Officer of Exomics, who has extensive expertise in developing and executing commercial strategies in medical device, and Ms. Virginia Kirby, executive in residence at the Discovery Launchpad at the University of Minnesota's Office of Technology Commercialization, who brings a wealth of clinical and regulatory experience in sleep disorders. I'm pleased to turn the call over to our CFO, Louis Moreau, who will provide a financial update.