Core Insights - Nyxoah (NYXH) has received a significant boost in reimbursement rates for its Genio hypoglossal nerve stimulation (HGNS) implants following the finalization of the CY2026 Hospital Outpatient Prospective Payment System (HOPPS) and Ambulatory Surgery Center (ASC) Rule by the U.S. Centers for Medicare & Medicaid Services (CMS) [1][8] Group 1: Reimbursement Changes - The CPT Code 64568 for Genio implants has been assigned to New Technology Ambulatory Payment Classification (APC) 1580, leading to increased reimbursement rates [1][9] - The new reimbursement rate for hospital outpatient departments is approximately $45,000, reflecting a 48% increase from 2025 levels [9] - The ASC facility reimbursement rate is set at $42,373, which is a 58% increase compared to 2025 [9][10] Group 2: Market Impact - The increase in reimbursement rates is expected to enhance the adoption of Genio implants, driving procedural throughput and expansion in Medicare-heavy institutions [5][10] - The single-incision procedure of Genio is well-suited for the ASC environment, creating new opportunities for therapy expansion [10] - Despite a 40% decline in share price this year, the improved reimbursement landscape may positively influence Nyxoah's prospects in 2026 [4][5] Group 3: Product Approval and Market Position - The Genio implant is approved for treating obstructive sleep apnea (OSA) through neuromodulation, with initial CE mark received in 2019 [2] - FDA approval was granted in August for a subset of adult patients with moderate to severe OSA [3] - The recognition of hypoglossal nerve stimulation as a high-value therapy for OSA is reinforced by the significant reimbursement rate increases [10]

Core Viewpoint - Nyxoah is actively participating in the Piper Sandler 37th Annual Healthcare Conference, showcasing its innovative solutions for Obstructive Sleep Apnea (OSA) treatment [1]. Company Overview - Nyxoah is a medical technology company focused on developing and commercializing innovative solutions for OSA, with its lead product being the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy [3]. - The company aims to improve the quality of life for OSA patients, allowing them to enjoy restful nights [3]. Product Development and Regulatory Approvals - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [4]. - Nyxoah has completed two successful IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [4]. - The company expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients after positive outcomes from the BETTER SLEEP study, which are currently contraindicated in competitors' therapies [4]. - 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, specifically those with an Apnea-Hypopnea Index (AHI) of 15 to 65 [4].

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 - Nyxoah SA reported a quarterly loss of $0.74 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.61, and compared to a loss of $0.55 per share a year ago, indicating a significant earnings surprise of -21.31% [1] - The company generated revenues of $2.31 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 18.02%, and showing an increase from $1.39 million in the same quarter last year [2] - Nyxoah shares have declined approximately 26.4% year-to-date, contrasting with the S&P 500's gain of 16.5% [3] Financial Performance - Over the last four quarters, Nyxoah has only surpassed consensus EPS estimates once [2] - The current consensus EPS estimate for the upcoming quarter is -$0.58 on revenues of $3.59 million, and for the current fiscal year, it is -$2.52 on revenues of $8.34 million [7] Market Outlook - The estimate revisions trend for Nyxoah was unfavorable prior to the earnings release, resulting in a Zacks Rank 4 (Sell), suggesting expected underperformance in the near future [6] - The outlook for the Medical Info Systems industry, where Nyxoah operates, is currently in the top 30% of over 250 Zacks industries, indicating a favorable environment that could impact stock performance positively [8]

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]

Financial Performance - Revenue for the nine months ending September 30, 2025, was €4.4 million, a 33.3% increase from €3.3 million for the same period in 2024[15] - The net loss for the nine months ending September 30, 2025, was €66.6 million, compared to a net loss of €42.1 million for the same period in 2024[19] - Revenue for the nine months ended September 30, 2025, increased to €4,376 thousand, up 34% from €3,258 thousand for the same period in 2024[31] - Gross profit for the nine months ended September 30, 2025, was €2,701 thousand, compared to €2,041 thousand for the same period in 2024, reflecting a growth of 32%[31] - The operating loss for the nine months ended September 30, 2025, was €64,857 thousand, compared to €40,498 thousand for the same period in 2024, indicating a loss increase of 60%[31] - Loss for the period for the nine months ended September 30, 2025, was €66,572 thousand, compared to €42,087 thousand for the same period in 2024, an increase of 58%[31] - Basic Loss Per Share for the nine months ended September 30, 2025, was €(1.778), compared to €(1.346) for the same period in 2024, reflecting a worsening of 32%[31] Expenses - Selling, general and administrative expenses rose by €15.4 million or 75.4%, from €20.4 million in 2024 to €35.8 million in 2025, driven by U.S. commercialization efforts[16] - Research and development expenses increased by €7.3 million or 27.8%, from €26.4 million in 2024 to €33.7 million in 2025[17] - Operating expenses for the nine months ended September 30, 2025, totaled €67.558 million, up from €42.539 million in the same period of 2024, marking an increase of approximately 58.8%[144] - The Company recognized an impairment loss of €0.8 million for a discontinued R&D project during the period ended September 30, 2025[71] - The Company recognized a gain of €92,000 from a modification of lease agreements during the nine months ended September 30, 2025[72] Cash and Assets - Cash and cash equivalents totaled €22.5 million as of September 30, 2025, down from €85.6 million on December 31, 2024[20] - Total assets decreased from €158,406 thousand as of December 31, 2024, to €93,599 thousand as of September 30, 2025, representing a decline of approximately 41%[28] - Cash and cash equivalents dropped significantly from €34,186 thousand as of December 31, 2024, to €10,869 thousand as of September 30, 2025, a decline of about 68%[28] - Current assets as of September 30, 2025, total €35.3 million, including €10.9 million in cash and cash equivalents and €11.6 million in marketable securities[51] - The total inventory increased to €6.1 million as of September 30, 2025, compared to €4.7 million as of December 31, 2024, driven by preparations for commercialization in the US and EU[75] Financing and Capital - The company is actively exploring financing options to meet future working capital needs, including public or private equity and debt financing[53] - The Company signed a €37.5 million loan facility agreement with the European Investment Bank, intended for research and development and scaling manufacturing capacity[122] - The first tranche of the loan facility, amounting to €10 million, was disbursed on July 26, 2024[123] - The company raised €45.9 million from the issuance of 5,374,755 new shares on May 28, 2024, at a share price of €8.54 per share in a public offering[94] - The total number of outstanding warrants increased from 2,040,231 as of September 30, 2024, to 3,218,569 as of September 30, 2025[104] Legal and Regulatory - The FDA approved the Genio system on August 8, 2025, for patients with an Apnea-Hypopnea Index (AHI) of 15 to 65, with commercialization efforts commencing shortly thereafter[14] - The company has engaged in litigation against Inspire Medical, Inc. for alleged patent infringement, with ongoing legal costs recognized in Research and Development Expense[128][129] Market and Sales - During Q3 2025, the company recognized €231,000 in revenue from U.S. sales following FDA approval[14] - The company expects to ramp up sales in Germany and other European markets, with ongoing efforts in the Middle East following successful distributor agreements[21] - The company generated its first revenue in Dubai in Q1 2025 and continued to expand into Kuwait and Abu Dhabi in Q2 2025[22] - The company generated revenue of €4.4 million in the first nine months of 2025, primarily from activities in the EU, with U.S. revenue starting in Q3 2025 amounting to €231,000[52] Employee and Management Compensation - The company reported total employee benefits of €31.9 million for the nine months ended September 30, 2025, up from €18.6 million for the same period in 2024[153] - For the nine months ended September 30, 2025, total remuneration for executive management was €3,082,000, a decrease of 7% from €3,315,000 in the same period of 2024[171] - Short-term remuneration for executive management increased to €1,994,000 for the nine months ended September 30, 2025, up 34% from €1,482,000 in 2024[171] Shareholder Information - As of September 30, 2025, the company's share capital amounts to €6.5 million represented by 37,544,782 shares, with a share premium of €332.7 million before transaction costs[91] - The share premium increased from €260.6 million on January 1, 2024, to €332.7 million on December 31, 2024[92] - The Company granted a total of 103,642 Restricted Stock Units (RSUs) to 7 directors, which vested at the shareholders' meeting in June 2025[114] Other Financial Information - Total financial liabilities increased to €11.7 million as of September 30, 2025, compared to €10.5 million as of December 31, 2024[64] - Total financial debt amounted to €19.035 million, an increase from €18.973 million as of December 31, 2024[116] - Financial income increased from €4.6 million for the nine months ended September 30, 2024, to €6.6 million for the nine months ended September 30, 2025, mainly due to fair value adjustments on synthetic warrants and increased exchange differences[155] - Total financial expenses increased from €5.5 million for the nine months ended September 30, 2024, to €8.2 million for the nine months ended September 30, 2025, primarily due to an increase in exchange differences[159]

Core Viewpoint - Nyxoah has secured financing commitments totaling up to U.S. $77 million to support the U.S. commercialization of its Genio system, which is designed to treat Obstructive Sleep Apnea (OSA) through neuromodulation [1][2]. Financing Details - The financing includes a €22 million private placement of equity, a U.S. $5.6 million registered direct offering, and a convertible bond financing of up to €45 million [2][7]. - The private placement involves the issuance of 5,481,678 new ordinary shares at a subscription price of €4.00 per share, generating gross proceeds of approximately €25 million [3]. - The registered direct offering consists of 1,215,964 new ordinary shares priced at U.S. $4.6304 per share, totaling approximately U.S. $5.6 million [5][6]. - The convertible bonds will have a maximum principal amount of up to €45 million, with the first tranche of €22.5 million expected to close in December 2025 [7]. Use of Proceeds - The net proceeds from the financing will be allocated to support U.S. commercialization activities, gather clinical data, finance research and development, and explore collaboration opportunities in OSA monitoring and diagnostics [8]. Company Background - Nyxoah is focused on developing innovative solutions for OSA, with its lead product being the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy [10]. - The Genio system received its European CE Mark in 2019 and FDA approval for certain adult patients in August 2025 [11][12].

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]