Nyxoah SA

Welcome to the third quarter 2024 earnings conference call. At this time, all participants are on a listen-only mode. After this presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1. You will then hear an automatic message advising your hand is raised. Please note that today's conference is being recorded. I will now hand the conference over to your speaker host, Michaela Kirkwood, Investor Relations and Communications Manager. Please go ahead.

Thank you. Good afternoon and good evening, everyone, and I welcome you to our earnings call for the third quarter of 2024. I am Michaela Kirkwood, Investor Relations and Communications Manager at Nixella. Participating from the company today will be Olivier Tailman, Chief Executive Officer, and Lalique Moreau, Chief Financial Officer. During the call, we will discuss our operating activities and review our third-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 material 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 these risks and uncertainties associated with our business, please refer to the risk factor section of our Form 20F filed with the Securities and Exchange Commission on March 20th, 2024. With that, I will now turn over the call to Olivier.

Thank you, Michaela. Good afternoon and good evening, everyone. And thank you for joining us for our third quarter of 2024 earnings call. 2024 has been an exciting year for NICSOA. In March, we announced our dream US pivotal study, achieved its efficacy endpoints with a strong safety profile. and demonstrated that Genio has the potential for best-in-class outcomes for obstructive sleep apnea patients. Subsequently, our regulatory team filed the fourth and final module in our Modular PMA submission at the beginning of June. Based on the timing of FDA site inspections, we expect FDA approval will be in the first quarter of 2025. We continue to be highly focused on the US opportunity ahead of our commercial launch, and we recently strengthened our balance sheet with €24.6 million in new capital raised in October from a single US healthcare dedicated fund. Throughout 2024, we have continued to bolster our US presence in anticipation of Genio's entry into the market with the hiring of executive roles in the US, with which include the addition of our Chief Medical Officer, Dr. Boone, Chief HR, Chief Commercial and Strategy Officers. Additionally, I relocated with my family to the U.S. in August to be on the ground during this critical time in the FDA approval and U.S. commercialization process. As you have also seen, we have recently hired John Landry to be our new Chief Financial Officer. John is an experienced U.S.-based public company CFO and brings a wealth of experience as we prepare for the US launch. Blue Week Moro, the current CFO, will transition into the newly created role of President International. In this capacity, Blue Week will focus on strengthening the company's presence in key international markets. In September, we presented the full dream data set at this year's International Surgical Sleep Society, or ISSS, meeting in Miami. To recap DREAM, the study had co-primary endpoints, apnea-hypopnea index or AHI responder rate per the shared criteria, and 12 months and oxygen desaturation index or ODI responder rate at 12 months. We reached all our endpoints and demonstrated a favorable safety profile. Looking at efficacy, the study shows AHI responder rates of 63.5 on an intent to treat ITT base and a 66.4 on a modified ITT base 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 of reducing the number of apneas and hypopneas, as well as the number of oxygen desaturation events that occur per hour of sleep. Now, what differentiates DREAM from previous AGNS studies is that it's the first study where patients were required to sleep at least 60 minutes or more in supine position and demonstrated comparable efficacy to non-supine sleep position, with a median 12-month AHI reduction of 70.8% when sleeping on their back. This will be of particular importance in the selection of physicians and the acceptance for patients, since in published data, it shows that AHI doubles in supine position, and people sleep on average between 35 to 40% of the night on their back. Currently, Genio is the only therapy with clinically proven evidence that it maintains its efficacy irrespective of patient's sleeping position. Another important criteria in the therapy selection will be reducing the cardiovascular risk, bringing it in line with dose of non-USA population, which was the case in Doreen with 82% of patients reducing their AHI below 15. In addition to high efficacy, Genio demonstrated a strong safety profile. driven by our single incision procedure. DREAM safety results included 11 series adverse events, or SAEs, in 10 patients, resulting in an SAE ratio of 8.7%. Out of the 11 SAEs, only three were device-related. These safety results compare favorably to existing AGNS therapies. In summary, DREAM data supports our mission to make sleep simple for patients, and reinforce our confidence that physicians will embrace Genio as a key treatment option for their OSI patients. Following the DREAM results, we submitted the fourth and final module of our PMA in June. We are currently in an interactive review with the FDA, which has already included several US clinical and manufacturing site visits completed without any deficiencies. Based on this progress made, In combination with the latest FDA communication regarding the final site visit timing in Belgium, we anticipate FDA approval first quarter 2025. On our way to commercialization, we are progressing with our reimbursement strategy. In advance of obtaining our own CPT code, we have identified the CPT code that best fits the Genio technology and is recognized by payers in the OSA indication. We are now working closely with the American Academy of Otolaryngology, or the AAO, and reimbursement experts in addition to participating in the FDA-initiated Early Payer Feedback Program to begin the process of educating CMS and other large commercial payers like United Healthcare, Blue Cross Blue Shield, and APNIA to help with obtaining coverage post-FDA approval. Once approved by the FDA, we will have a dedicated team to support pre-authorization efforts at the site level. In anticipation of FDA approval, we continue to actively build our U.S. commercial organization. We have already onboarded our senior commercial leadership team, including the chief commercial officer, the VP of sales, the chief commercial strategy officer, and director of market access. Additionally, we have standout offers for the first wave of territory managers, as well as key marketing and market access personnel with the aim of having the commercial team fully operational by the time of launch. We anticipate the size of the commercial organization will be approximately 50 people at this time, or at that time. As we think about our commercial launch strategy, it is too prompt. First, we will focus on Tier 1 hyperlossal nerve stimulation implanting accounts where market research suggests that physicians and patients are actively seeking an attractive alternative to currently available therapy. Second, we will focus on driving referrals from sleep physicians who currently manage a high number of patients with moderate to severe OSA who are in need of an alternative treatment. Both of these efforts will be supported by focused DTC investments. We are coming into our US launch with a well-known experience from our efforts in Europe, in particular Germany, which has served as a proof of concept for the technology and our go-to-market approach. Although the German market size is much smaller than the US market, There are key learnings that have informed of US commercialization strategy. Similar to the US market, the German market is highly concentrated with Tier 1 implanting accounts, making up a majority of the markets. Of the top 10 accounts, Genio has quickly been embraced by 9 of them. Additionally, we have focused on establishing a referral pathway with top sleep specialists focused on patients who have quit CPAP. By the end of 2024, we will have 15 referral sleep centers across Germany. The ResMed Nixoa collaboration should confirm this strategy in the coming quarters. These activities are being supported by focused DTC efforts. Our entry into the market has resulted in an acceleration of AGNS market growth in the region, and we have achieved a 25% overall market share only 24 months after launch. We believe that our approach to the German market and the success we have had in the region can serve as a good proxy for our adoption trajectory in the US. In summary, with strong DREAM data, a differentiated AG&S system, upcoming regulatory approval and a cash run rate that has been extended to mid-2026, I could not be more excited for the future of Niksoa as we move closer to a U.S. commercial launch. With that, I'm pleased to turn the call over to our CFO, Loïc Moreau, who will provide a financial update.