2025年11月26日， Nyxoah 宣布其舌下神经刺激系统 Genio 获得美国 Medicare 报销的大幅提升 。此次调整来自 CMS 发布的 2026 年医院门诊支付系统 （HOPPS）与门诊手术中心（ASC）终版规则。 在新规则中，CPT 64568（舌下神经刺激植入）被重新归类至 新 技术支付类别 APC 1580 。这意味着： 对于 Nyxoah 来说，这是继 2025 年 8 月 Genio 获得 FDA 批准后，在美国商业落地路径上的又一个关键节点。公司表示，更强的报销基础将支持 Genio 在美国 市场的加速采用，尤其是 在 Medicare 占比高的机构与增长迅速的 ASC 场景中 。 # 产品与技术机制：以"无导线 + 体外供能"差异化切入 OSA 神经调控 Genio 属于舌下神经刺激（Hypoglossal Nerve Stimulation, HNS）疗法，通过刺激控制舌肌的舌下神经，使舌根前移，从而维持气道开放，是 阻塞性睡眠呼吸暂 停 （OSA）中替代 CPAP 的重要路径之一。 与当前市场龙头 Inspire Medical 的系统相比，Genio 的技术路径具有几个核心 ...

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was EUR 2 million, a 56% increase from EUR 1.3 million in Q3 2024 [12] - Gross margin decreased to 60.5% in Q3 2025 from 62% in Q3 2024 [12] - Total operating loss increased to EUR 24.4 million in Q3 2025 from EUR 15 million in Q3 2024, attributed to increased commercial investments in the U.S. [12] - Cash position decreased to EUR 22.5 million at September 30, 2025, down from EUR 43 million at June 30, 2025 [12] - The company secured up to $77 million in capital to support U.S. commercialization efforts [13] Business Line Data and Key Metrics Changes - The first commercial Genio implant in the U.S. generated $231,000 in revenue during Q3 2025 [5] - 15 implants were performed across nine accounts in the U.S. by the end of October 2025 [24][25] - 111 surgeons were trained on Genio, and 102 value analysis committee submissions were completed, with 35 approvals received [6][7] Market Data and Key Metrics Changes - The company is focused on expanding its U.S. commercial organization and has secured reimbursement with Medicare and 10 private payers [9][10] - The company is also driving deeper penetration in Germany and the UK, while selectively expanding into the Middle East [11] Company Strategy and Development Direction - The company aims to manage obstructive sleep apnea (OSA) as a chronic condition, integrating AI and self-learning into future Genio products [15] - The focus is on expanding the U.S. commercial organization and training more surgeons to activate more accounts [11] - The company is positioned to differentiate itself in the market by offering a bilateral stimulation solution that respects the anatomy of the hypoglossal nerve [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the U.S. launch, noting strong enthusiasm from physicians and patients for the Genio solution [4] - The company anticipates continued progress in securing coverage decisions from additional commercial payers [10] - The fourth quarter 2025 revenue is expected to be between EUR 3.4 million and EUR 3.6 million, reflecting ongoing growth in both U.S. and international markets [14] Other Important Information - The company has achieved a 100% approval rate on prior authorization submissions through its GEMIO access program [9] - The inclusion of CPT code 64568 in medical policies by major payers is expected to streamline patient access [10] Q&A Session Summary Question: Feedback from doctors and patients on choosing Genio - Physicians appreciate the optionality Genio provides and its bilateral stimulation solution, which is effective for complex airway obstructions [18] Question: Status of sales force build-out - The company is focused on high-volume AGNS sites and plans to add up to 15 territory managers quarterly to cover all 400 high-volume implant sites [19] Question: Number of implants and U.S. revenue in Q3 - A total of 15 implants were performed through the end of October, generating EUR 231,000 in revenue [24][25] Question: Guidance for U.S. versus international revenue - The company is not breaking out U.S. versus international revenue at this time, as it is still in the early phases of account activation in the U.S. [26] Question: Appeal of Genio among different demographics - Genio appeals to both male and female patients, with a focus on younger individuals who value the implant for life concept [35] Question: KPIs for future reporting - The company plans to provide updates on the number of surgeons trained and accounts that have implanted, while potentially dropping value analysis committee metrics in the future [41] Question: Pricing and average selling price (ASP) - The average selling price for implants is around $25,000, with expectations for U.S. revenue to grow from October to December [47][48] Question: Impact of U.S. rollout on gross margins - Long-term gross margins are expected to reach the 80% range, with improvements anticipated from the next-generation Genio and increased production volumes [50][52] Question: Phasing of reimbursement progress - The CPT code 64568 is expected to remain in use for the long term, providing a clear pathway for reimbursement with both Medicare and commercial payers [58][59]

Summary of Nyxoah Conference Call Company Overview - **Company**: Nyxoah - **Industry**: Hypoglossal Nerve Stimulation (HG&S) for Obstructive Sleep Apnea (OSA) Key Points Commercial Launch and Structure - Nyxoah launched its Genio device on August 11, with a focus on high-volume accounts in the U.S. market [3][6] - Currently, there are approximately 1,500 implanting accounts, with 400 accounts generating 75% of the volume [3][11] - The commercial team consists of 25 territory managers targeting 125 high-volume accounts, with plans to add 75 new accounts each quarter [6][11] - The strategy emphasizes quality over quantity, focusing on high-volume centers of excellence [11][12] Training and Surgeons - As of now, 121 surgeons have been trained across the 125 targeted accounts, indicating strong momentum [17][18] - Feedback from surgeons highlights the optionality and clinical differentiation of Genio compared to existing treatments [18][24] Patient Identification and Demand - The target patient demographic includes those who prefer not to have a battery implanted and those with positional OSA [23][24] - There is a noted pre-existing demand for Genio among patients who previously opted out of traditional implants [25][26] Surgical Proficiency and Time - The average surgical time has decreased from 90 minutes for initial procedures to around 60 minutes as surgeons gain experience [29][30] - The fastest recorded implant was completed in 32 minutes by an experienced surgeon [30] Reimbursement and Payer Relationships - All reimbursement submissions to Medicare and private payers have been approved, with no rejections reported [32][33] - Major payers like Blue Cross Blue Shield and UnitedHealth have accepted the reimbursement code for Genio [32][34] Financial Strategy and Funding - The company is focusing investments on U.S. commercial launch and innovation while managing cash burn effectively [41][42] - Plans to raise capital to support four to five quarters of commercial success are in place [42] Future Opportunities and Trials - The Axis trial for the triple C indication has stopped enrollment, with potential label approval expected by late 2026 or early 2027 [45][46] - Nyxoah aims to differentiate itself from competitors by focusing on innovative platforms rather than traditional pacemaker solutions [47][48] GLP-1 Impact - The introduction of GLP-1 medications is seen as a positive development, potentially increasing the patient pool for OSA treatments [60][63] - Nyxoah's strategy focuses on managing chronic diseases and improving patient outcomes through innovative solutions [61][63] Next Generation Technology - Future developments aim to eliminate wearable components, incorporating self-learning systems for patient convenience [67][68] - By 2030, Nyxoah expects to offer devices without any wearable components, enhancing user experience [68] Additional Insights - The company emphasizes the importance of patient management and setting correct expectations for treatment outcomes [59][61] - Nyxoah's approach to OSA treatment is positioned as a long-term chronic disease management strategy, focusing on patient ownership and compliance [48][61]

Company Expansion - Nyxoah SA announced the expansion of its commercial footprint in the Middle East following the first successful Genio implant in Abu Dhabi in September 2025 [1][9] - The company aims to partner with healthcare institutions in Dubai, Kuwait, and Abu Dhabi to enhance access to the Genio system for OSA patients who cannot tolerate CPAP [3][9] Product Overview - Genio is the only leadless, externally powered bilateral hypoglossal nerve stimulation system for treating moderate-to-severe obstructive sleep apnea (OSA) [1][9] Market Potential - The global sleep apnea devices market was valued at $4.5 billion in 2023 and is projected to reach $6.9 billion by 2030, growing at a CAGR of 6.2% [4] - Factors driving market growth include an aging population, a significant patient pool with sleep apnea, and increased prevalence of comorbidities associated with sleep apnea [4] Competitive Landscape - Inspire Medical Systems reported strong revenue growth and market penetration in its second-quarter results, indicating a competitive environment in the OSA space [7] - Resmed Inc. launched the Sleep Institute to advance sleep health, reflecting ongoing innovation and focus in the industry [8][10] - LivaNova PLC initiated the commercial launch of the Essenz Perfusion System in China and reported solid revenue growth, showcasing competitive dynamics in the market [11]

Summary of Nyxoah (NYXH) 2025 Conference Call Company Overview - **Company Name**: Nyxoah - **Industry**: Medical Technology (MedTech) - **Focus**: Innovative solutions for treating obstructive sleep apnea (OSA) patients - **Key Product**: Genio solution, which received FDA approval on August 8, 2025, and launched in the U.S. on August 11, 2025 [6][20] Market Insights - **Obstructive Sleep Apnea Market**: - Significant market with millions of patients in the U.S. suffering from moderate to severe OSA [5][7] - The market is described as having "blockbuster potential" due to the large number of eligible patients for treatment [9] - **Current Treatment Landscape**: - CPAP (Continuous Positive Airway Pressure) is the gold standard but has a compliance issue, with nearly 50% of patients discontinuing use after 2-3 years [10][11] - Genio aims to fill the gap for patients who cannot tolerate CPAP [19] Product Differentiation - **Genio Device Mechanism**: - Utilizes bilateral stimulation to maintain airway openness during sleep by contracting the genioglossus muscle [12][14] - No implantable battery, making it more patient-friendly and MRI compatible [14][15] - Software updates can be performed without surgery, enhancing user experience [15] Commercial Strategy - **U.S. Market Entry**: - Focused launch strategy targeting high-volume centers and establishing relationships with key customers [20][26] - Initial revenue expected to ramp up in 2026, with foundational work being done in 2025 [27][28] - **Operational Expenditures**: - R&D spending expected to increase in the mid-single digits percentage-wise compared to the previous year [30] - SG&A expenses projected to rise by 66-75% due to investments in the U.S. commercial organization [31] Financial Outlook - **Current Cash Position**: - €43 million in cash as of June, with a reduced cash burn from €23 million to €20 million in Q2 [38][39] - Sufficient cash to sustain operations into 2026, with plans to evaluate capital-raising options [40] - **Revenue Breakeven Point**: - Estimated to be around $200 million, which is lower than competitors, allowing for a more targeted commercialization approach [41] Future Developments - **Data Collection and Registry**: - Plans to establish a registry to collect patient data and health economic data to support payer negotiations [32][34] - **Future Product Iterations**: - Development of a smart implant capable of automatic adjustments and a closed-loop system for enhanced patient experience [35][36] Key Takeaways - Nyxoah is positioned to capitalize on a significant market opportunity in the OSA space with its innovative Genio solution - The company is focused on building a strong commercial presence in the U.S. while managing operational expenditures effectively - Future growth will depend on successful market penetration, patient compliance, and ongoing product development initiatives [6][20][27]

Group 1 - The company Nyxoah has received FDA approval for its innovative Genio product, marking a significant milestone in its development [1] - Nyxoah has published its second-quarter earnings, which are crucial for assessing its financial health and growth potential [1] - The analysis emphasizes a focus on undervalued companies with strong fundamentals and good cash flows, highlighting the potential for substantial returns in sectors like Oil & Gas and consumer goods [1] Group 2 - The analyst expresses a long-term value investing approach, while also engaging in deal arbitrage opportunities, indicating a flexible investment strategy [1] - There is a clear preference for companies that are well understood, avoiding high-tech and certain consumer goods sectors, which may indicate a risk-averse investment philosophy [1] - The analyst aims to connect with like-minded investors through Seeking Alpha, fostering a community focused on informed decision-making and superior returns [1]

Financial 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]