Nyxoah(NYXH)2024-11-08 23:46Financial Data and Key Metrics Changes - Revenue for Q3 2024 was €1.3 million, with an operating loss of €15 million compared to €11 million in Q3 2023, driven by increased commercial investments in the U.S. [30] - Cash and financial assets totaled €71 million as of September 30, 2024, with a monthly cash burn of €5.6 million during the quarter [31]. Business Line Data and Key Metrics Changes - The company has focused on strengthening its U.S. presence in anticipation of the Genio product launch, including hiring key executive roles [10][12]. - The DREAM study demonstrated strong efficacy with an AHI response rate of 63.5% on an intent-to-treat basis and 66.4% on a modified intent-to-treat basis [13]. Market Data and Key Metrics Changes - The company has achieved a 25% overall market share in the German market within 24 months of launch, which serves as a model for U.S. market entry [28]. - The U.S. hypoglossal nerve stimulation market is experiencing strong growth, with estimates of over 30% growth [63]. Company Strategy and Development Direction - The company is preparing for a U.S. commercial launch with a two-pronged strategy focusing on Tier 1 implanting accounts and driving referrals from sleep physicians [24][54]. - The reimbursement strategy includes using an established CPT code recognized by payers for OSA indications at launch, with plans to pursue a Genio-specific CPT code over time [39][80]. Management's Comments on Operating Environment and Future Outlook - Management anticipates FDA approval for Genio in Q1 2025, citing delays in site inspections as a reason for the revised timeline [50]. - The company is confident in its ability to meet demand from a supply standpoint, with two manufacturing sites operational [73]. Other Important Information - The company raised €24.6 million in October 2024 to strengthen its balance sheet ahead of the U.S. commercialization [9]. - The company has established a dedicated team to support preauthorization efforts at the site level post-FDA approval [22]. Q&A Session Summary Question: Feedback from clinicians on DREAM data - Positive feedback was received regarding the unique requirement for patients to sleep in a supine position, with comparable efficacy to non-supine positions [35][36]. Question: Details on reimbursement and CPT code - The company is executing a comprehensive reimbursement strategy, confirming the use of an established CPT code at launch [39][40]. Question: Timing of peer-reviewed publication of DREAM data - The publication is being prepared by the principal investigator and is expected in the coming weeks [45]. Question: Changes in FDA approval timeline - The timeline has shifted to Q1 2025 due to delays in the Belgium site inspection [50]. Question: Commercialization strategy and Tier 1 accounts - The company will focus on high-volume Tier 1 accounts, which represent 80% of current revenue [71]. Question: Confidence in supply meeting demand - The company has two operational manufacturing sites and sufficient inventory to serve both U.S. and European markets [73].