Nyxoah SA

Good day everyone and thank you for standing by. Welcome to NICSOA second quarter 2024 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 participate you will need to press star 1 1 on your telephone. You will then hear a message advising your hand is raised. To withdraw your question simply press star 1 1 again. Please be advised that today's conference is being recorded. I will pass the call over to your first speaker today, Michaela Kirkwood.

Thank you and good afternoon and good evening, everyone, and welcome to our earnings call for the second quarter and first half of 2024. I am Michaela Kirkwood, Investor Relations and Communications Manager at Nextella. Participating from the company today will be Olivier Tellman, Chief Executive Officer, and Elise Moreau, Chief Financial Officer. During the call, we will discuss our operating activities and review our second quarter financial results released after U.S. market closed 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 of the investor relations tab of our 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 a description of the risks and uncertainties associated with our business, please refer to the risk factors section of our Form 20-F filed with the Securities and Exchange Commission on March 20th, 2024. With that, I will now turn the call over to Olivier.

Thank you, Michaela. Good afternoon and good evening, everyone. And thank you for joining us for our second quarter and first half of 2024 earnings call. 2024 is a pivotal year for Niksola, with an increased focus on preparing for U.S. market entry. In March this year, we announced our dream U.S. pivotal study, achieved its primary endpoints, and demonstrated that Genium has the potential for best-in-class outcomes Subsequently, our regulatory team filed the fourth and final module in our model of PMA submission, which has set the stage for FDA approval as early as the end of 2024. We strengthened recently our balance sheet with over 85 million euros in new capital raised, which extends our cash runway into mid-2026. and are actively building our US commercialisation organisation, led by our recently hired new Chief Commercial Officer, Scott Holstein. Commercially, we reported first half 2024 European sales of 2 million euros, representing an increase of 29% from the first half of 2023, and ended the second quarter with 55 active implanting accounts in Germany. To recap DREAM, the study had co-primary endpoints of AHI responder rate per the shared criteria at 12 months and ODI responder rate at 12 months. At baseline, subjects had a mean AHI of 28 and an ODI of 27 and a body mass index of 28.5. On an intent-to-treat or ITT basis, The DREAM study showed an AHI respond rate of 63.5% with a p-value of 0.002 and an ODI respond rate of 71.3% with a p-value less than 0.001. With these strong results, the DREAM study met its primary endpoints. Additionally, subjects demonstrated a median 12-month AHI reduction of 70.8% with similar AHI improvements in supine and non-supine sleeping positions. The safety results were favorable, with 11 severe adverse events, or SAEs, in 10 subjects, resulting in an SAE rate of 8.7%. Out of the 11 severe adverse events, 3 were device-related and there were 3 explants. We will present the full DREAM data at a lunch symposium at the ISSS conference in Miami, end of September, on September 27 to be precise, and look forward to see many of you there. The DREAM results further differentiate GMO, as it was the first hyperglycemic nerve stimulation study to require patients to sleep at least 60 minutes in the supine position and demonstrates strong efficacy with patients sleeping supine and non-supine, just like mimicking a normal night of sleep. This is of particular importance since published data show increased OSA severity when a patient is on his back or in the supine position, with AHI doubling in the supine versus the lateral position. On average, people sleep 35 to 40% on their back during normal night or standard nights, which was in line with our PSG findings in green. This means that irrespective of a patient's sleeping position, Genio maintains its efficacy, and that is unique. Based on feedback from the physicians, this will be very impactful on therapy selection. It supports our mission to make sleep simple again, and we have applied for the inclusion of the supply and efficacy results into our label. With the positive DREAM results, we have completed our Modular PMA submission. We have responded to all the FDA questions on the first three modules thus far and submitted the fourth and final module. Based upon Modular PMA review cycle times, we anticipate FDA approval in late 2024. As we do not control FDA timelines, early 2025. In anticipation of the FDA approval, we are actively building our U.S. commercial organization. In July, Scott Holstein joined NICSOA as Chief Commercial Officer after 26 years in the medical device industry. In addition to Scott, key leadership in sales, marketing, and market access are in place, and we are actively kicking off the recruitment of top sales and marketing talent. At launch, we will target the Tier 1 or top hyperglossal nerve stimulation implanting sites in the US that account for 85% of all procedures done in the US. The organization will be composed of territory sales managers, supported by field engineers and field field specialists, each with their own responsibilities. The territory sales manager will be the owner of the territory revenue. interacting with surgeons and sleep doctors. Field engineers and sleep specialists will be focused on high-quality implants and patient outcomes on the other hand. The advantage of this structure is that it's focused and scalable, providing territory managers the ability to drive increased integrity penetration without the distraction of covering implants and performing titrations. Consequently, we can have more focused DTC, helping territory managers locally increase patients' referrals for a Genio implant. Independent market research and feedback from 31 top hyperosomal stimulation implant surgeons in the US who participated in our recent usability study reinforced Genio's differentiation versus current AGNS technology in terms of invasiveness, patient-centricity, safety, and the simplicity to treat or save patients regardless of their sleep position. Genio offers patients a leadless, full-body 1.5 and 3 Tesla MRI-compatible, non-implanted PET-free solution, powered and controlled by a wearable component. Our vision of an implant-for-life concept, powered and controlled by a wearable component, allows patients to always have the most advanced technology without the need for another surgery. Given these characteristics, we expect Genio to be market-expanding in the US, as a significant number of hyperlossal nerve stimulation candidates currently are declining pacemaker-based platform technology due to concerns over invasiveness and having an implantable battery in their chest. This view is supported by independent surveys demonstrating that over 20% of U.S. hyperlossal nerve stimulation candidates are turning down existing technology and strong interest in system with genio features and form factor. Going back to Europe, first half 2024 sales were 2 million, representing an increase of 29% from the first half of 2023. and we ended June with 55 active implanting accounts. As a reminder, Germany is our commercial proof of concept. Although the German market has some different characteristics than the US market, there are key learnings that will help us in developing a successful US commercialization strategy. Similar to the US market, the German market is highly concentrated. and Genio was embraced by doctors and patients in those Tier 1 or top accounts, resulting in an acceleration in the hippococcal nerve stimulation market growth. Of the top 10 accounts, 9 are currently implanting Genio, and in 5, we have at least 30% market share after 24 months. This is a strong property for the US launch, where we will initially focus on the top implanting Tier 1 To continue to drive growth into these accounts, establishing a referral pathway with top sleep specialists focused on CPAP quitting patients and converting them in a timely manner will be a key to sustained success. The ResMed-NYXOA collaboration should confirm this strategy in the coming quarters. In summary, with strong dream data, a differentiated AG&S system, and a cash runway into mid-2026, it could not be more excited for the future at Mixora. With that, I'm pleased to turn the call over to our CFO, Loïc Moreau, who will provide a financial update.