As of Dec. 31, 2025, Taelman said Nyxoah’s team was focused on 125 of the top 400 U.S. accounts. Within that group, the company trained 145 surgeons across 125 high-volume accounts. Nyxoah completed 120 Value Analysis Committee (VAC) submissions and had received 57 VAC approvals by quarter-end, with “no VAC rejections to date,” he said.Nyxoah received U.S. FDA approval for Genio on Aug. 8, 2025 and began actively launching the product, with “first implants and revenue as early as September 2025,” according ...

Financial Data and Key Metrics Changes - For Q4 2025, gross revenue was EUR 6.3 million before revenue deferrals of EUR 700,000, resulting in net revenue of EUR 5.6 million, compared to EUR 1.3 million in Q4 2024, indicating significant growth driven by the U.S. commercial launch [14] - Full year 2025 gross revenue was EUR 11 million before EUR 1 million of revenue deferrals, resulting in net revenue of EUR 10 million, a 122% increase from EUR 4.5 million in 2024 [15] - Gross margin for Q4 2025 was 64%, while the full year gross margin was 63% [14][15] - Total operating loss for Q4 2025 was EUR 18.6 million, relatively stable compared to EUR 18.3 million in Q4 2024, while the full year operating loss increased to EUR 83.5 million from EUR 58.8 million in 2024 [15] Business Line Data and Key Metrics Changes - The U.S. commercial launch generated approximately EUR 3.5 million of net revenue in Q4 2025, with $4.5 million in revenue generated from the first full quarter of launch [14][5] - 145 surgeons were trained in 125 high-volume hypoglossal nerve stimulation accounts, with 57 receiving positive Value Analysis Committee approval [5][7] Market Data and Key Metrics Changes - The company secured reimbursement for Genio across both Medicare and commercial payers, with Medicare representing 10% of the business and commercial payers approximately 90% [9][10] - The introduction of new C-codes for hypoglossal nerve stimulation by CMS is expected to facilitate billing and reimbursement processes [10] Company Strategy and Development Direction - The company aims to continue executing its U.S. commercial launch, having increased its sales force to 40 sales reps covering 200 of the top 400 hypoglossal nerve stimulation accounts [17] - Plans for 2026 include expanding internal manufacturing to strengthen competitive position and improve gross margins [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the U.S. launch momentum and the opportunity ahead, with expectations for U.S. net revenue to grow 25% sequentially in Q1 and Q2 2026 [16] - The company anticipates a strong financial profile as it gains market share in the U.S. [17] Other Important Information - The DREAM pivotal study published in the Journal of Clinical Sleep Medicine demonstrated Genio's clinical efficacy, differentiating it from competitors [6] - The company closed 2025 with a global gross revenue of EUR 11 million, driven by strong Q4 U.S. launch momentum [6] Q&A Session Summary Question: Update on VAC submissions and account activations - Management confirmed 120 VAC submissions with 57 approvals, expecting more approvals in Q1 2026 [21][22] Question: Timing for ACCESS study data and PMA supplement submission - The 12-month data will be available by the end of June 2026, with submission planned for Q1 2027 [24] Question: Cash burn rate and guidance for 2026 - Cash burn is approximately EUR 20 million per quarter, expected to decrease as revenue traction increases [29] Question: Competitor's coding strategy and implant numbers - Management indicated plans to pursue dedicated coding for Genio by 2028, while not disclosing specific implant numbers [31][33] Question: Key drivers for Genio adoption among physicians - Surgeons are attracted to Genio's unique features, including bilateral stimulation and a single incision procedure [51]

Financial Data and Key Metrics Changes - For Q4 2025, gross revenue was EUR 6.3 million before EUR 700,000 of revenue deferrals, resulting in net revenue of EUR 5.6 million, compared to EUR 1.3 million in Q4 2024, indicating significant growth driven by the U.S. commercial launch [14] - Full year 2025 gross revenue was EUR 11 million before EUR 1 million of revenue deferrals, resulting in net revenue of EUR 10 million, a 122% increase from EUR 4.5 million in 2024 [15] - Gross margin for Q4 2025 was 64%, while the full year gross margin was 63% [14][15] - Total operating loss for Q4 2025 was EUR 18.6 million, relatively stable compared to EUR 18.3 million in Q4 2024, while the full year operating loss increased to EUR 83.5 million from EUR 58.8 million in 2024 [14][15] Business Line Data and Key Metrics Changes - The U.S. commercial launch generated approximately EUR 3.5 million of net revenue in Q4 2025, with $4.5 million of revenue generated from the first full quarter of launch [14][5] - 145 surgeons were trained in 125 high-volume hypoglossal nerve stimulation accounts, with 57 receiving positive Value Analysis Committee approval [5][7] - The company reported consistent reimbursement from both commercial payers (approximately 90% of business) and Medicare (10% of business) during Q4 [9][10] Market Data and Key Metrics Changes - The company closed 2025 with a global gross revenue of EUR 11 million, driven by strong momentum from the U.S. launch [6] - Internationally, growth continued in selected markets, including Germany, the United Kingdom, and the Middle East, with Germany being the first international market to reach profitability [12] Company Strategy and Development Direction - The company aims to continue executing its U.S. commercial launch, having increased its sales force to 40 sales reps covering 200 of the top 400 hypoglossal nerve stimulation accounts [17] - The company is expanding its internal manufacturing footprint to strengthen its competitive position and improve gross margins [17] - The company plans to submit a PMA supplement for the ACCCESS study data by the end of July 2026, potentially leading to U.S. label expansion in early 2027 [24][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the U.S. launch momentum and the opportunity ahead, emphasizing the positive feedback from surgeons and patients regarding Genio's unique features [8][12] - The reimbursement environment is viewed as a normal maturation of an established therapy, with clarity on facility fees expected to support further adoption of Genio [11] - The company anticipates a sequential growth of 25% in U.S. net revenue for the first and second quarters of 2026, driven by continued surgeon training and growing adoption [16] Other Important Information - The company reported a cash position of EUR 48 million as of December 31, 2025, with an expected cash burn rate of approximately EUR 20 million per quarter in the near term [15][29] - The introduction of new C-codes for AGNS by CMS is expected to facilitate billing for traditional Medicare patients, aligning reimbursement for Genio with competitors [10][9] Q&A Session Summary Question: Can you provide an update on the remaining VAC processes and new account activations? - Management confirmed that 120 VAC submissions were made, with 57 approved, and expects the remaining approvals to occur in Q1 2026 [20][21] Question: What is the timeline for the ACCCESS study data and PMA supplement submission? - The 12-month data will be available by the end of June 2026, with analysis taking up to 30 days, leading to a PMA supplement submission by the end of July 2026 [23][24] Question: What is the cash burn rate and guidance for 2026? - The cash burn rate is approximately EUR 20 million per quarter, expected to decrease as revenue traction increases in the U.S. [29] Question: How many implants have been performed, and what is the approach to inventory? - Management clarified that they do not disclose precise implant numbers but indicated that revenue generated in Q4 suggests a significant number of implants were performed [33][34] Question: What are the key drivers for Genio adoption among physicians? - Key drivers include the optionality provided by Genio, its single incision technique, and bilateral stimulation, which resonate well with surgeons [50][51]

Financial Data and Key Metrics Changes - In Q4 2025, gross revenue was EUR 6.3 million before deferrals, resulting in net revenue of EUR 5.6 million, compared to EUR 1.3 million in Q4 2024, indicating significant growth driven by the U.S. commercial launch [13] - For the full year 2025, gross revenue was EUR 11 million, leading to net revenue of EUR 10 million, a 122% increase from EUR 4.5 million in 2024 [14] - Gross margin for Q4 2025 was 64%, while the full year gross margin was 63% [13][14] - Total operating loss for Q4 2025 was EUR 18.6 million, relatively stable compared to EUR 18.3 million in Q4 2024 [13] - Total operating loss for the full year 2025 was EUR 83.5 million, up from EUR 58.8 million in 2024, reflecting increased commercialization activities [14][15] Business Line Data and Key Metrics Changes - The U.S. commercial launch generated approximately EUR 3.5 million of net revenue in Q4 2025, with $4.5 million in revenue generated from the first full quarter of launch [13][5] - 145 surgeons were trained across 125 high-volume hypoglossal nerve stimulation accounts in the U.S. [6] - 57 Value Analysis Committee approvals were received, with no rejections to date [6][7] Market Data and Key Metrics Changes - The U.S. market is the primary growth driver, with international markets contributing consistently, particularly in Germany, the UK, and the Middle East [12] - Medicare reimbursement for Genio has been consistent, representing 10% of the business, while commercial payers account for approximately 90% [9][10] Company Strategy and Development Direction - The company aims to continue executing its U.S. commercial launch, having increased its sales force to 40 sales reps covering 200 of the top 400 hypoglossal nerve stimulation accounts [17] - Plans include expanding internal manufacturing to strengthen competitive position and improve gross margins [17] - The company is preparing for a PMA supplement submission based on 12-month ACCCESS study data, potentially leading to U.S. label expansion in early 2027 [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the U.S. launch momentum and the opportunity ahead, with expectations of 25% sequential growth in U.S. net revenue for Q1 and Q2 2026 [16] - The reimbursement environment is viewed as a normal maturation of an established therapy, with clarity on facility fees expected to support further adoption [11] Other Important Information - The company has a cash position of EUR 48 million as of December 31, 2025, with an expected cash burn of approximately EUR 20 million per quarter in the near term [15][30] - The introduction of new C-codes for AGNS by CMS is anticipated to facilitate billing for traditional Medicare patients [10] Q&A Session Summary Question: Status of Value Analysis Committee submissions and account activations - Management confirmed 120 VAC submissions with 57 approvals, expecting more approvals in Q1 2026 [20][21] Question: Timing for ACCCESS study data and PMA supplement submission - The 12-month data will be available by the end of June 2026, with submission planned for Q1 2027 [23][25] Question: Cash burn rate and guidance for 2026 - Cash burn is approximately EUR 20 million per quarter, expected to decrease as revenue traction increases [29][30] Question: Competitor's coding strategy and implant numbers - Management indicated plans to pursue dedicated coding for Genio, with no specific implant numbers disclosed but revenue figures suggest a strong sales performance [31][34] Question: Patient demographics for Genio implants - Patients are primarily coming from established referral networks, with many choosing Genio for its minimally invasive design and upgradeable features [59]

Core Insights - Nyxoah reported strong financial and operational results for Q4 and full year 2025, highlighting a successful U.S. commercialization launch and positive feedback from surgeons and patients [2][5][9] Financial Performance - Q4 2025 gross revenue reached €6.3 million, with net revenue of €5.6 million, reflecting a 347% year-over-year growth [5][8] - Full year 2025 gross revenue was €11.0 million, resulting in net revenue of €10.0 million, a 122% increase compared to 2024 [9] - The gross margin for Q4 2025 was approximately 64%, while the full year gross margin was around 63% [5][11] Cost Structure - Cost of goods sold for Q4 2025 was €2.0 million, leading to a gross profit of €3.6 million [10] - For the full year, cost of goods sold totaled €3.7 million, with a slight decrease in gross margin from 66% in 2024 to 63% in 2025 due to increased sales volume and operational ramp-up [11] Research and Development - R&D expenses for Q4 2025 were €10.9 million, down from €11.8 million in Q4 2024 [12] - Full year R&D expenses increased to €42.8 million from €34.3 million in 2024, driven by clinical expansion and product development [12] Selling, General and Administrative Expenses - SG&A expenses for Q4 2025 were €12.5 million, compared to €8.1 million in Q4 2024 [13] - For the full year, SG&A expenses rose to €48.3 million from €28.5 million in 2024, reflecting the build-out of the U.S. commercial organization [13] Operating Loss - The operating loss for Q4 2025 was €18.6 million, slightly higher than €18.3 million in Q4 2024 [14] - The total operating loss for the full year was €83.5 million, compared to €58.8 million in 2024, attributed to increased commercialization investments and clinical initiatives [14] Cash Position - As of December 31, 2025, cash, cash equivalents, and financial assets amounted to €48.0 million [15] U.S. Commercialization Strategy - The U.S. commercial launch of the Genio® system began in August 2025, with a focus on high-volume implanting centers and education for referral networks [3][6] - By the end of 2025, 145 surgeons had been trained, and 57 accounts activated in the U.S. [5][6] Future Revenue Guidance - The company anticipates U.S. net revenue for Q1 2026 to grow by approximately 25% over Q4 2025, with similar growth expected for Q2 2026 [24]

Summary of Nyxoah's Conference Call Company Overview - **Company**: Nyxoah - **Industry**: MedTech, specifically focused on the treatment of obstructive sleep apnea (OSA) through neuromodulation solutions - **Market Opportunity**: The U.S. OSA market is valued at approximately $10 billion, identified as a blockbuster market with significant under-penetration [2][3] Core Points and Arguments - **FDA Approval**: Nyxoah has received FDA approval and is actively launching its product in the U.S. market [2] - **Technology Differentiation**: The Genio system offers a unique bilateral mode of action, which is minimally invasive and does not require an implanted battery, making it distinct from competitors [3][9] - **Clinical Evidence**: The DREAM study demonstrated a 63.5% reduction in the Apnea-Hypopnea Index (AHI) and a 71.3% oxygen desaturation responder rate, indicating strong efficacy and safety [15][16] - **Market Penetration**: Nyxoah has implanted over 1,000 patients in Europe and is commercially reimbursed in several countries, including Germany, the U.K., and the UAE [3][19] - **U.S. Commercial Strategy**: The company focuses on high-volume hypoglossal nerve implanting accounts, which represent about 70% of the total market volume in the U.S. [19][20] - **Sales Team**: Nyxoah has a dedicated U.S. sales team of approximately 60 people, with 40 focused on high-volume accounts [20] Reimbursement Insights - **CPT Codes**: Nyxoah has secured CPT codes recognized by both Medicare and private payers, including major insurers like UnitedHealthcare and Blue Cross Blue Shield [22][36] - **CMS Communication**: Recent updates from CMS indicate that both Genio and its competitors will receive a facility fee of $31,526 for implants, ensuring continued reimbursement [37][40] - **Market Dynamics**: There is a clear need for dedicated codes for hypoglossal nerve stimulation (HGNS) as the market evolves with multiple technologies [36][37] Competitive Landscape - **Demand Drivers**: The demand for Genio is driven by physician and patient needs for alternatives to battery-implanted devices, as well as the clinical superiority of the Genio system in treating complex airway obstructions [29][30] - **Patient Preferences**: Patients prefer the discreet single incision and the absence of a battery replacement requirement, which enhances the appeal of Genio [32] Financial Outlook - **Revenue Break-Even**: Nyxoah aims to achieve revenue break-even at approximately EUR 150 million, with an expected gross margin of over 80% [42] - **Operational Leverage**: The company has built out its organization to scale effectively, with limited direct-to-consumer (DTC) spending compared to competitors [43] Additional Insights - **Geographic Expansion**: Nyxoah is selectively expanding into international markets, with plans to enter Singapore and other Asian markets [24] - **Patient Engagement**: The Genio system includes a smart wearable component and an app for monitoring sleep data, enhancing patient involvement and data collection for healthcare management [12][13] Conclusion - Nyxoah is positioned as a significant player in the OSA treatment market with a differentiated technology, strong clinical evidence, and a focused commercialization strategy. The company is navigating the complexities of reimbursement while expanding its market presence and enhancing its product offerings [25][36]

Company Overview - Nyxoah is a medical technology company focused on developing and commercializing innovative solutions for treating Obstructive Sleep Apnea (OSA) [3] - The company's lead product is the Genio system, which is a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for OSA [3] Recent Developments - Nyxoah will participate in the Oppenheimer 36th Annual Healthcare MedTech & Services Conference from March 16 to 19, 2026 [1] - CEO Olivier Taelman will present on March 16, 2026, at 8:40 am ET, with a webcast available on the company's Investor Relations website [2] - The company will also hold one-on-one meetings with institutional investors during the conference [2] Product Milestones - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [4] - Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021 [4] - The company received CE mark approval for expanding therapeutic indications to Complete Concentric Collapse (CCC) patients after positive outcomes from the BETTER SLEEP study [4] - The FDA approved the Genio system for a subset of adult patients with moderate to severe OSA in August 2025 [4]

Core Viewpoint - Nyxoah SA will release its financial results for the fourth quarter and full year of 2025 on March 19, 2026, and will host a conference call to discuss these results [1]. Company Overview - Nyxoah is a medical technology company focused on developing innovative solutions for Obstructive Sleep Apnea (OSA) through neuromodulation [4]. - The company's lead product is the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy for OSA, a condition linked to increased mortality risk and cardiovascular issues [4]. Recent Developments - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [5]. - Nyxoah has completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021 [5]. - The company received CE mark approval for expanding therapeutic indications to Complete Concentric Collapse (CCC) patients after positive outcomes from the BETTER SLEEP study [5]. - Nyxoah announced positive results from the DREAM IDE pivotal study and received FDA approval for a subset of adult patients with moderate to severe OSA [5]. Financial Communication - A conference call will take place on March 19, 2026, at 10:30 PM CET / 4:30 PM ET to discuss the financial results [1]. - The call will be accessible via the Investor Relations page of Nyxoah's website [2]. - For those wishing to ask questions, registration is required, and an email will be sent with dial-in details and a unique access code [3]. Additional Information - The archived webcast of the call will be available for replay shortly after the call concludes [3]. - For more information about Nyxoah and its products, the company encourages visiting its website [6].

Core Insights - Nyxoah has signed a Memorandum of Understanding (MoU) with Sheikh Shakhbout Medical City (SSMC) to enhance Obstructive Sleep Apnea (OSA) therapy management and improve access to its Genio® therapy in the Middle East [1][2] Group 1: Partnership and Strategic Focus - The MoU aims to position SSMC as a leading regional center for Genio therapy, focusing on developing a high-volume implant program centered on patient care [2] - The collaboration includes establishing SSMC as a training hub for Genio therapy, educating surgeons, sleep physicians, and healthcare professionals across the region [3] Group 2: Clinical and Research Initiatives - Discussions are ongoing to explore clinical research and collaboration in sleep apnea and chronic disease management [3] - The initiative aligns with Nyxoah's vision to provide new treatment options for OSA patients and investigate the impact of advanced OSA management on chronic diseases like type 2 diabetes [4] Group 3: Company Overview and Product Information - Nyxoah specializes in developing innovative solutions for OSA, with its lead product being the Genio system, a leadless and battery-free hypoglossal neurostimulation therapy [5] - The Genio system received its European CE Mark in 2019 and has expanded its therapeutic indications following successful studies, including the BETTER SLEEP study and DREAM IDE pivotal study [6]

Core Viewpoint - Nyxoah is making a significant investment to expand its manufacturing capacity in Belgium to support growth in the U.S. and international markets [1][2][3] Group 1: Investment and Expansion - Nyxoah has signed an agreement with LégiaPark to create a nearly 2,000 square meters manufacturing facility, including a state-of-the-art cleanroom [2] - The investment aims to enhance Nyxoah's product development activities and strengthen its strategic partnership with Noshaq, contributing to local job creation [2][3] Group 2: Manufacturing and Technology - The new cleanroom facility is designed to be scalable, allowing for future growth alongside Nyxoah's manufacturing needs [3] - ABN Cleanroom Technology is collaborating with Nyxoah to develop the cleanroom, emphasizing innovation and local expertise in Belgium [3][9] Group 3: Company Overview - Nyxoah specializes in developing innovative solutions for Obstructive Sleep Apnea (OSA), with its lead product being the Genio system, a battery-free neurostimulation therapy [4][5] - The Genio system received its European CE Mark in 2019 and has expanded its therapeutic indications following successful studies [5]