Nyxoah(US: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] - 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 [28] - Cash position improved to €85.6 million at the end of 2024, up from €57.7 million at the end of 2023, aided by a €24.6 million equity raise [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 was €5.1 million, an 18% increase over 2023 [23] Market Data and Key Metrics Changes - The company launched Genio in the UK and UAE, with the UK expected to become a significant market 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 building referral networks with sleep physicians [17][18] - A two-pronged strategy will be employed for market penetration, targeting both existing HGNS centers and developing new referral networks [19][32] - The company plans to utilize CPT code 64568 for reimbursement, which is recognized by commercial and government payers for OSA indication [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in receiving FDA approval by the end of March 2025, citing ongoing positive interactions with the FDA [31][50] - The company is focused on establishing competitive pricing and strong referral networks to drive adoption of Genio in the U.S. market [31][32] - Management highlighted the importance of real-world data collection post-launch to support clinical and economic justification of the technology [70] Other Important Information - The DREAM study showed 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][11] - Genio demonstrated a favorable safety profile with an 8.7% severe adverse event rate [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 [37] Question: Trajectory of U.S. launch and new account openings - Management indicated that they will focus on training physicians and expanding into high-volume HGNS accounts, aiming to cover all Tier 1 accounts within 12 to 18 months [44] Question: Confidence in FDA approval timeline - Management remains confident in the approval timeline, citing a 90-day review clock that aligns with their expectations for a March approval [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 [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 the technology's clinical and economic justification [70]