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's Genio therapy has received significant reimbursement increases for 2026 under the final CMS rule, which is expected to enhance the commercial rollout in the U.S. [1][3] - The reimbursement for the Genio system's CPT code 64568 will rise to approximately $45,000 for Hospital Outpatient Departments (HOPD), a 48% increase from 2025, and to $42,373 for Ambulatory Surgery Centers (ASC), reflecting a 58% increase [2][3] Summary by Sections Reimbursement Changes - The final CMS rule assigns CPT code 64568 to New Technology APC 1580, which strengthens the economic foundation for therapy adoption in U.S. hospitals and ASCs [1][3] - The reimbursement increases apply uniformly to all procedures billed under CPT 64568, supporting broader adoption and increased procedural throughput [3] Therapy Expansion Opportunities - The significant increase in ASC facility payment creates new opportunities for therapy expansion and diversification of service sites [4] - The Genio system's single-incision procedure is particularly well-suited for the ASC environment, enhancing its appeal [4] Company Background - Nyxoah is focused on developing innovative solutions for Obstructive Sleep Apnea (OSA), with its lead product being the Genio system, a leadless and battery-free hypoglossal neurostimulation therapy [5][6] - The company has received various regulatory approvals, including the European CE Mark in 2019 and FDA approval in August 2025 for specific patient subsets [6]

Core Insights - The company reported strong third-quarter results with a revenue of $224.5 million, a 10% increase year-over-year, and reaffirmed its full-year revenue guidance of $900 to $910 million, representing a growth of 12% to 13% compared to 2024 [8][15][18] - The Inspire 5 system has shown significant clinical performance improvements, including an 87% inspiratory overlap with patient breathing and a 20% reduction in surgical times [4][5] - The company is experiencing positive feedback from clinical studies, indicating that Inspire therapy can reduce long-term cardiovascular morbidity and mortality compared to CPAP treatment [6][7] Financial Performance - Total revenue for the third quarter was $224.5 million, with U.S. revenue at $214.4 million, a 9% increase from the previous year [15] - Operating income for the quarter was $9.6 million, down from $14.3 million in the prior year, with net income at $9.9 million compared to $18.5 million [16][17] - The company increased its earnings per share guidance to 90¢ to $1, up from a previous range of 40 to 50¢ [8][19] Market and Product Development - The Inspire 5 launch is progressing well, with over 98% of physician training completed and over 75% of centers onboarding SleepSync [7][8] - The company is focusing on expanding its market access and has seen a positive trend in reimbursement, with CMS finalizing an 11% increase for CPT code 64568 [9][10] - The company is also leveraging the growing interest in sleep health driven by GLP-1 treatments, which is bringing more patients into clinics [11][12] Strategic Initiatives - The company is committed to enhancing patient outcomes through innovation and clinical evidence, with ongoing investments in medical education and patient marketing [7][13] - A new advertising campaign has been launched to promote Inspire therapy, featuring notable partnerships to increase awareness [9] - The company is actively working to transition centers from Inspire 4 to Inspire 5, with a focus on training and support for lower-volume centers [40][41] Future Outlook - The company anticipates a revenue growth of 10% to 11% for 2026, influenced by the ongoing adoption of Inspire 5 and the impact of GLP-1 treatments [22][23] - The company is monitoring competitive dynamics and expects to provide formal guidance for 2026 in January [22][58] - The company is also addressing operational efficiencies through territory management and optimizing the ratio of territory managers to field clinical representatives [77][78]

Financial Data and Key Metrics Changes - The company reported a guidance reduction of approximately 4.5% for the second half of the year, primarily driven by the transition to Inspire five, with a more significant impact of about 9% for the second half [13][14] - The management noted an increase in patient warehousing dynamics, indicating patients are waiting for Inspire five despite the availability of Inspire four, affecting the patient funnel [14][15] Business Line Data and Key Metrics Changes - The transition to Inspire five is progressing well, with surgeon training and certification reaching approximately 99%, up from 90% [4][5] - Contracting with implanting accounts has improved to over 80% from 70% [5] - The implementation of the Sleep Sync programmer has increased to about 65% from 50% [6][7] Market Data and Key Metrics Changes - The company expects to complete the transition from Inspire four to Inspire five by the end of the year, with full adoption anticipated across all implanting accounts [9] - The management highlighted that the coding issue related to Medicare has been resolved, removing a previous headwind [10][11] Company Strategy and Development Direction - Inspire five is seen as a catalyst for growth, with expectations of increased productivity and efficiency in procedures, allowing for more cases to be handled [29][30] - The company is focusing on expanding its footprint by adding more territory managers and field clinical representatives to support the growth of Inspire five [30][31] - Medical education is emphasized as a key growth vector, targeting both early career professionals and experienced surgeons [30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, stating that the market opportunity is massive and underpenetrated, with a commitment to innovation and improved patient outcomes [80] - The impact of GLP-1 medications on patient dynamics is still being assessed, with both positive and negative effects observed [19][20] Other Important Information - The company is preparing to present data at upcoming conferences, showcasing the efficacy and operational efficiency of Inspire five [34][35] - Management acknowledged the competitive landscape, particularly with the introduction of new hypoglossal nerve stimulation devices, but remains confident in their product's advantages [45][46] Q&A Session Summary Question: What is the reason for the guidance reduction? - The guidance reduction is primarily due to the slower transition to Inspire five, which has led to patient warehousing dynamics and inventory destocking of Inspire four [14][15] Question: How is the company addressing competition from GLP-1 medications? - The management noted that while GLP-1s may delay some patients, they also create opportunities for new patients to enter the treatment funnel as they lose weight [19][20] Question: What are the expectations for Inspire five adoption? - Full adoption of Inspire five is expected by the end of the year, with significant progress already made in surgeon training and account readiness [9][32] Question: How does the company view the total addressable market (TAM)? - The management believes the TAM is growing, driven by increased awareness and diagnosis rates for obstructive sleep apnea [43] Question: What is the company's strategy regarding international markets? - While the focus remains on the U.S. market, the company is also exploring opportunities in international markets, particularly in Europe and Asia [74][75]