PresentationGood morning, everyone, and welcome to the 44th Annual JPMorgan Healthcare Conference. My name is Varun, and it is my pleasure to invite on stage today Nyxoah, represented by their CEO, Olivier Taelman. Please put your hands together for Olivier.Olivier TaelmanCEO & Executive Director Thank you. Let me start by thanking JPMorgan for the invitation. My name is Olivier Taelman. I am the CEO of Nyxoah. Nyxoah, a medtech company offering an innovative solution by neurostimulation to help patients su ...

Nyxoah FY Conference Summary Company Overview - **Company**: Nyxoah (Ticker: NYXH) - **Industry**: Medtech, specifically focused on neurostimulation solutions for obstructive sleep apnea (OSA) - **Recent Milestone**: Obtained FDA approval in August 2025, actively launching products in the U.S. market [2][30] Market Opportunity - **Addressable Market**: Approximately 450,000-500,000 eligible patients in the U.S. for Genio technology, representing a market opportunity of around $10 billion [3] - **Market Penetration**: Currently, only 8% of the eligible patient population receives therapy, indicating a largely underpenetrated market [3] Product and Technology - **Genio Technology**: A differentiated, patient-first neurostimulation device with a unique bilateral mode of action [3][10] - **Clinical Evidence**: Robust clinical data from the DREAM study, showing efficacy in reducing Apnea-Hypopnea Index (AHI) and oxygen desaturation index [18] - **Patient Compliance**: Recorded over 87% compliance and 92% patient satisfaction [15] Treatment Landscape - **Current Treatment Options**: - CPAP (Continuous Positive Airway Pressure) is the gold standard but has a high quit rate (50% annually) [7][8] - Mandibular advancement devices have low predictability and high out-of-pocket costs [7] - Traditional surgery is invasive with a low success rate (30%-60%) [9] - Unilateral hypoglossal nerve stimulation has limitations due to battery implantation [10] Clinical Outcomes - **Efficacy Results**: - Median AHI reduction of over 70% after 12 months [20] - 82% of patients had AHI below 15, equating their morbidity risk to non-OSA individuals [20] - **Safety Profile**: Serious adverse event rate of 8.7%, lower than the average for neuromodulation solutions [18][19] Commercial Strategy - **Market Entry**: Successfully captured 25% market share in Germany within 24 months without direct-to-consumer marketing [21] - **U.S. Market Focus**: Targeting high-volume ENT surgeons and collaborating with sleep physicians for patient referrals [22][23] - **Reimbursement Strategy**: Established CPT code 64568, achieving 100% acceptance of pre-authorization files from major payers [25][36] Future Outlook - **Expansion Plans**: Focus on U.S. market while selectively expanding in Europe and UAE [40] - **Clinical Studies**: Ongoing trials for Complete Concentric Collapse (CCC) patients, with results expected in June 2026 [27][37] - **Technological Advancements**: Plans to enhance the wearable component and explore additional nerve stimulation options [38][39] Key Takeaways - Nyxoah is positioned to disrupt the OSA treatment market with its innovative Genio technology, backed by strong clinical evidence and a clear commercial strategy - The company is focused on expanding its market presence in the U.S. while maintaining a commitment to patient-first technology and improving treatment outcomes [28][29]

Nyxoah FY Conference Summary Company Overview - **Company**: Nyxoah (NasdaqGM:NYXH) - **Industry**: Medical Technology, specifically focused on hypoglossal nerve stimulation for obstructive sleep apnea (OSA) Key Points U.S. Launch Status - Nyxoah received FDA approval on August 8, 2025, and began its U.S. launch on August 11, 2025 - As of early December, the company has focused on high-volume hypoglossal nerve stimulation accounts, covering approximately 125 out of 400 targeted accounts, which represent about 75% of U.S. revenue volume [6][10] - The company has trained 128 surgeons and submitted 108 pre-market approval (PMA) submissions, with a 100% approval rate for pre-authorizations from private payers and CMS [9][10] Sales Force Expansion - Nyxoah has added 15 territory managers, increasing the total to 40, which will allow the company to target an additional 75 high-volume implant accounts [10][21] - The commercial organization now consists of 50 people, including market access personnel and field engineers [19][20] Financial Guidance and Market Share - For Q4 2025, Nyxoah provided revenue guidance of EUR 3.4 million to EUR 3.6 million [23] - The U.S. H&S market is projected to be around $1 billion in 2026, with Nyxoah aiming for a market share significantly higher than the 3% initially suggested, potentially reaching 15%-25% in focused accounts [24][25] Patient Outcomes and Data Collection - Early feedback from surgeons on patient outcomes post-implantation has been positive, with successful airway openings observed [27][29] - Nyxoah is required to conduct a post-PMA study to follow up on patients, which will also help in developing health economic data [29] Reimbursement Updates - A significant reimbursement change effective January 1, 2026, will increase facility fees for CPT code 64568 by 40%-50%, which is expected to encourage more hospitals to adopt hypoglossal nerve stimulation [30][31] - Nyxoah plans to observe the market dynamics and will not deviate from its focused launch strategy despite the reimbursement changes [32] Long-term Reimbursement Strategy - Nyxoah anticipates the establishment of a dedicated H&S code for reimbursement, moving away from a monopoly of existing technologies [37] GLP-1 Impact - The introduction of GLP-1 medications is seen as a positive development, potentially expanding the patient base eligible for treatment due to improved BMI and AHI metrics [38][39] Future Studies and Innovations - Nyxoah is preparing for a study on Complete Concentric Collapse (CCC) with data expected in August 2026 and potential U.S. commercialization in late 2026 or early 2027 [41][45] - The company is also exploring dual stimulation modalities involving Ansa cervicalis, with first human trials expected within six months [48][49] Financial Performance and Projections - Gross margins are expected to improve from the low 60s to the low 80s by 2027 due to new product innovations and increased volume [52] - Operating expenses will rise as the sales force expands, with a focus on maintaining R&D investment [54] Financing and Cash Runway - Recent financing efforts have provided sufficient capital to support U.S. commercialization through early 2027, allowing flexibility for future funding decisions [55][56] Closing Remarks - Nyxoah emphasizes its commitment to providing options for OSA patients and its enthusiasm for the future of its technology [58]