Core Insights - Nyxoah reported strong initial results following the U.S. launch of its Genio system for treating Obstructive Sleep Apnea (OSA), achieving first revenue within a month post-FDA approval [2][4][5] Financial Highlights - Revenue for Q3 2025 was €2.0 million, a 56% increase year-over-year from €1.3 million in Q3 2024 [8][9] - The company reported a gross profit of €1.2 million with a gross margin of 60.5% for Q3 2025, compared to a gross margin of 62.0% in Q3 2024 [9][11] - Operating loss for Q3 2025 was €24.4 million, up from €15.0 million in Q3 2024, primarily due to increased selling, general, and administrative expenses [13][12] Market Launch and Strategy - The company executed a two-pronged launch strategy targeting high-volume hypoglossal nerve stimulation centers and building referral networks with sleep physicians [5][6] - As of October 31, 2025, 111 surgeons were trained on the Genio system, with 9 accounts having implanted the device [6] Reimbursement Progress - Significant progress was made in securing reimbursement coverage, with updates from major payors like Health Care Service Corporation and Blue Cross Blue Shield of Michigan, impacting over 26 million members [7][8] Cash Position - As of September 30, 2025, cash, cash equivalents, and financial assets totaled €22.5 million, down from €43.0 million at the end of June 30, 2025 [14]

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]

Core Insights - Nyxoah SA will participate in the Stifel 2025 Healthcare Conference on November 11, 2025, presenting at 9:20 AM Eastern Time via webcast [2][3] Company Overview - Nyxoah is a medical technology company focused on innovative solutions for Obstructive Sleep Apnea (OSA), with its lead product being the Genio system, a leadless and battery-free hypoglossal neurostimulation therapy [4] - The Genio system received its European CE Mark in 2019 following the successful BLAST OSA study and has since expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients [5] - The company completed IPOs on Euronext Brussels in September 2020 and NASDAQ in July 2021, and received U.S. FDA approval for a Premarket Approval application in August 2025 [5]

Core Points - Nyxoah will release its financial results for the third quarter of 2025 on November 13, 2025, followed by a conference call to discuss these results [1][2][3] 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 after the successful completion of the BLAST OSA study [5] - Nyxoah has completed two IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [5] - Following positive outcomes from the BETTER SLEEP study, the company expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients, which are currently contraindicated in competitors' therapies [5] - The company also announced positive results from the DREAM IDE pivotal study and received U.S. FDA approval for a Premarket Approval application in August 2025 [5]

Core Viewpoint - Wall Street anticipates a year-over-year decline in earnings for Nyxoah SA despite higher revenues, with actual results being crucial for stock price movement [1][2]. Earnings Expectations - Nyxoah is expected to report a quarterly loss of $0.61 per share, reflecting a year-over-year change of -10.9% [3]. - Revenues are projected to be $1.95 million, which is an increase of 40.3% compared to the same quarter last year [3]. Estimate Revisions - The consensus EPS estimate has been revised down by 6.1% over the last 30 days, indicating a reassessment by analysts [4]. - The Most Accurate Estimate for Nyxoah is higher than the Zacks Consensus Estimate, resulting in an Earnings ESP of +19.67% [12]. Earnings Surprise Prediction - A positive Earnings ESP reading suggests a potential earnings beat, particularly when combined with a strong Zacks Rank [10]. - Nyxoah currently holds a Zacks Rank of 4, making it challenging to predict an earnings beat despite the positive Earnings ESP [12]. Historical Performance - In the last reported quarter, Nyxoah was expected to post a loss of $0.62 per share but actually reported a loss of -$0.63, resulting in a surprise of -1.61% [13]. - Over the past four quarters, Nyxoah has only beaten consensus EPS estimates once [14]. Industry Comparison - In the Zacks Medical Info Systems industry, Hims & Hers Health, Inc. is expected to report earnings of $0.09 per share, indicating a year-over-year change of +50% [18]. - Hims & Hers Health's revenue is expected to be $583.68 million, up 45.4% from the previous year [19].

Core Insights - Nyxoah has initiated the U.S. commercial rollout of its Genio system for obstructive sleep apnea (OSA) after receiving FDA approval, marking a significant advancement in the company's market presence [2][8] - The first successful implants in the U.S. indicate strong early demand from physicians and expanding payor coverage, setting the stage for nationwide adoption [3][9] Company Developments - The Genio system is a leadless, battery-free neurostimulation device that offers a minimally invasive treatment option for OSA, differentiating itself from traditional devices [11] - Nyxoah's market capitalization stands at $168.6 million, with an expected earnings growth of 8.8% by 2026 [6] Market Dynamics - The global sleep apnea devices market was valued at $4.5 billion in 2023 and is projected to grow to $6.9 billion by 2030, with a compound annual growth rate (CAGR) of 6.2% from 2024 to 2030 [13] - Factors driving market growth include an aging population, a significant number of patients with sleep apnea, and advancements in device technology [14] Competitive Position - Nyxoah's Genio system is positioned to become a preferred therapy in the sleep apnea market due to its innovative design and ease of use, potentially enhancing the company's competitive edge [12] - Early traction in the market, including surgeon enthusiasm and hospital approvals, suggests a strong foundation for revenue growth as procedure volumes increase [10][5]

Core Insights - Nyxoah has successfully implanted the first U.S. commercial patients with the Genio® system, marking a significant milestone in the treatment of Obstructive Sleep Apnea (OSA) [1][2] - The company has achieved strong physician demand, successful pre-authorizations, and widespread payor coverage, including approvals from major payors like CMS [2] - The Genio system is a leadless and battery-free hypoglossal neurostimulation therapy, aimed at providing innovative solutions for OSA patients [3] Company Overview - Nyxoah is focused on developing and commercializing innovative solutions for OSA, with the Genio system as its lead product [3] - The company aims to improve the quality of life for OSA patients by providing effective treatment options [3] Product Development and Approval - The Genio system received its European CE Mark in 2019 and U.S. FDA approval in August 2025 as a prescription-only device [4][5] - The company has completed two successful IPOs, on Euronext Brussels in September 2020 and NASDAQ in July 2021 [4] Market Indicators - Nyxoah is tracking several metrics as leading indicators of future revenue growth, including the number of trained surgeons, value analysis committee submissions, prior authorization submissions, and accounts opened [7]

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]

Core Insights - Several small- and mid-cap biotech and medical stocks experienced significant after-hours trading activity on September 26, driven by clinical updates, investor presentations, and strategic announcements. Company Summaries - **Enanta Pharmaceuticals Inc. (ENTA)**: The stock surged 20% in after-hours trading to $9.48 after closing at $7.90, following the announcement of upcoming topline results from its Phase 2b study on zelicapavir for RSV treatment in high-risk adults [2][3]. - **Acumen Pharmaceuticals Inc. (ABOS)**: Shares rebounded 12.67% to $1.60 after closing at $1.42, driven by renewed interest in its Alzheimer's pipeline, particularly the Phase 2 candidate Sabirnetug (ACU193) [4]. - **Delcath Systems Inc. (DCTH)**: The stock gained 6.00% in after-hours trading to $11.39 after closing at $10.74, following renewed investor interest in its CHOPIN Phase 2 trial data presentation scheduled for ESMO 2025 Congress [5][6]. - **Vivos Therapeutics Inc. (VVOS)**: The stock climbed 4.81% to $3.27 after closing at $3.12, likely due to renewed interest following recent positive clinical trial results for its pediatric OSA treatment [7][8]. - **Xilio Therapeutics (XLO)**: Shares rose 4.28% to $0.83 after closing at $0.7959, driven by enthusiasm surrounding the initiation of a Phase 2 trial for its tumor-activated IL-12 candidate, which also triggered a $17.5 million payment from Gilead [9][10]. - **Nyxoah SA (NYXH)**: The stock increased 3.77% to $4.68 after closing at $4.51, supported by optimism regarding its international expansion and a recent patent infringement lawsuit against Inspire Medical Systems [11].

Core Insights - Nyxoah is expanding its presence in the Middle East with new centers in Dubai, Kuwait, and Abu Dhabi, following the first successful Genio® implant in the region in September 2025 [2][4]. Company Overview - Nyxoah is a medical technology company 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 Genio system received its European CE Mark in 2019 and has undergone successful IPOs on Euronext Brussels and NASDAQ [6]. Market Expansion - The Middle East is identified as a significant and growing market for Nyxoah, with the company partnering with leading healthcare institutions to enhance access to the Genio solution for OSA patients who cannot tolerate CPAP [3][4]. - The expansion into Kuwait and Abu Dhabi is part of Nyxoah's strategy to broaden its commercial footprint and improve patient outcomes in the region [4].