Nyxoah(NYXH)2025-03-13 20:45Financial Data and Key Metrics Changes - The company recorded deferred revenue of €600,000 in Q4 2024, with recognized revenue of €1.3 million for the quarter and €4.5 million for the full year 2024 [27][28] - Total operating loss for Q4 2024 was €18.3 million, compared to €10.8 million in Q4 2023, driven by increased R&D spending and commercial investments in the U.S. [28] - Cash position improved to €85.6 million at the end of 2024, up from €57.7 million at the end of 2023 [28] Business Line Data and Key Metrics Changes - Revenue for Q4 2024 would have been €1.9 million excluding the impact of deferred revenue, representing a 46% sequential growth over Q3 2024 [23] - Full-year revenue increased by 18% to €5.1 million compared to 2023 [23] Market Data and Key Metrics Changes - The company launched Genio in the UK and UAE, with the UK expected to become one of the largest international markets due to NHS coverage [24][25] - The first successful implant in the UK generated excitement, and the company plans to expand into more hospitals [25] Company Strategy and Development Direction - The company aims to launch Genio in the U.S. by the end of March 2025, focusing on high-volume HGNS implanting centers and developing referral networks with sleep physicians [17][19] - A two-pronged strategy will be employed for market penetration, targeting both existing HGNS centers and sleep physicians managing OSA patients [17][19] - The company plans to utilize CPT code 64568 for reimbursement, which is recognized by commercial and government payers for OSA indications [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in receiving FDA approval by the end of March 2025, with ongoing discussions focused on labeling [31][50] - The company anticipates significant growth in 2025, with a focus on U.S. market entry and further international expansion [32][30] Other Important Information - The DREAM study demonstrated a strong AHI responder rate of 63.5% and an ODI responder rate of 71.3%, with a median AHI reduction of 70.8% [8][12] - Genio's safety profile showed an 8.7% severe adverse event rate, which is expected to positively influence therapy selection by physicians [14] Q&A Session Summary Question: Update on reimbursement and CPT code 64568 - Management acknowledged that while the reimbursement level may not be overly attractive, having a recognized CPT code is crucial for market entry [36][38] Question: Trajectory of U.S. launch and account openings - Management indicated that they are targeting approximately 300 to 350 high-volume HGNS sites for initial account openings, with plans to scale up quarterly [40][44] Question: Confidence in FDA approval timeline - Management remains confident in the March approval timeline, citing a 90-day review clock and positive interactions with the FDA [49][50] Question: Manufacturing and supply chain readiness - Management confirmed that they have sufficient manufacturing capacity and inventory for the U.S. market, with products being manufactured domestically [63][64] Question: Need for real-world data post-approval - Management plans to collect real-world data as part of their post-market study to support clinical and economic justification [70][71] Question: Key differentiators for Genio versus competitors - Management highlighted the benefits of bilateral stimulation and the ability to upgrade the system without additional surgery as key differentiators [78][80] Question: Timing of DREAM publication and ACCCESS enrollment - Management expects the DREAM study publication in a leading medical journal in the coming months and anticipates completing ACCCESS enrollment by mid-2025 [83][84]