20-F: Nyxoah Reports 2025 Financials, FDA Approval Fuels US Commercial Launch

Nyxoah SA achieved FDA approval for its Genio system in August 2025, driving significant revenue growth in 2025, despite continued operating losses and ongoing concerns about its ability to continue as a going concern.

Summary

• Nyxoah SA reported revenue of €10.0 million for the year ended December 31, 2025, a 122% increase from €4.5 million in 2024.
• The company incurred an operating loss of €83.5 million in 2025, up from €58.8 million in 2024.
• Net loss for the period was €90.1 million in 2025, compared to €59.2 million in 2024.
• Cash and cash equivalents stood at €30.0 million as of December 31, 2025, with financial assets of €18.0 million.
• The company's accumulated deficit reached €306.0 million as of December 31, 2025.
• FDA approval for the Genio system was received on August 8, 2025, leading to the commencement of U.S. commercialization in September 2025.
• The DREAM pivotal trial met its primary endpoints, demonstrating a 63.5% AHI responder rate and 71.3% ODI responder rate at 12 months.
• Enrollment for the ACCCESS clinical trial was stopped in Q3 2025, with initial 12-month data expected in Q3 2026.
• A post-approval study, BREATHE, is authorized by the FDA and expected to enroll 229 patients starting Q2 2026.
• Nyxoah secured €22 million in equity financing and a convertible bond financing of up to €45 million in November 2025.
• The company's cash runway is expected to extend into Q3 2026, potentially into Q1 2027 with full convertible bond and EIB loan tranches.
• Material weaknesses in internal control over financial reporting were identified and remain unresolved as of December 31, 2025.

Sentiment

Score: 3

Explanation: StockSavvy.ai views this as a challenging period for Nyxoah, marked by significant financial losses and going concern doubts, despite positive regulatory and clinical milestones for its core product. The need for substantial additional capital and unresolved internal control issues temper the optimism from market expansion.

Positives

• Revenue increased by 122% to €10.0 million in 2025, driven by commercial expansion and U.S. launch.
• Received FDA approval for the Genio system on August 8, 2025, enabling commercialization in the significant U.S. market.
• The pivotal DREAM trial successfully met its primary endpoints, showing a 63.5% AHI responder rate and 71.3% ODI responder rate.
• Clinical data from the DREAM study also showed significant improvements in quality of life metrics (FOSQ-10, ESS, SNORE-25) and a reduction in snoring.
• Secured €22 million in equity financing and a convertible bond financing of up to €45 million in November 2025, extending the cash runway.
• The Genio system is MR Conditional for full-body MRI scans at both 1.5T and 3T, a competitive advantage over other neurostimulation therapies.
• Expanded CE Mark indication in Europe for OSA patients with Complete Concentric Collapse (CCC) in October 2021, based on BETTER SLEEP trial data.
• Received Breakthrough Device designation from the U.S. FDA for OSA with CCC in September 2021.
• The Genio 2.1 system, with smartphone application and upgraded external activation chip, received FDA approval in August 2025 and CE Mark approval in July 2022, enhancing patient experience and compliance.
• Strong and growing intellectual property portfolio with 337 granted patents and pending applications as of December 31, 2025.
• Strategic partnerships, including an exclusive license agreement with Vanderbilt University for new neurostimulation technologies.

Negatives

• The company continues to incur significant operating losses, with a loss of €83.5 million in 2025, a 47% increase from 2024.
• Net loss for the period increased by 52% to €90.1 million in 2025.
• There is substantial doubt about the company's ability to continue as a going concern for at least twelve months from the date of the annual report, with current funds insufficient to cover this period.
• Accumulated deficit reached €306.0 million as of December 31, 2025.
• Identified material weaknesses in internal control over financial reporting remain unresolved as of December 31, 2025, potentially impacting financial reporting accuracy and fraud prevention.
• The company will require an additional €110 million in capital to reach profitability (positive Adjusted EBITDA at €150 million annual revenue).
• Research and development expenses increased by 25% to €42.8 million in 2025.
• Selling, general and administrative expenses increased by 80% to €48.3 million in 2025.
• The company is involved in patent infringement litigation with Inspire Medical Systems, Inc., both as defendant and plaintiff, which could incur substantial costs and divert management attention.
• The closure of the Israel R&D department in the second half of 2025 indicates a restructuring or scaling down of certain R&D activities.
• Enrollment for the ACCCESS clinical trial was stopped in Q3 2025 prior to enrolling all 106 potential patients, which could impact the comprehensiveness of data for CCC patients.

Risks

• **Limited Operating History and Profitability**: The company has a limited operating history and has incurred losses since inception, with no guarantee of future profitability.
• **Going Concern Doubt**: Substantial doubt exists about the company's ability to continue as a going concern, dependent on securing additional funding.
• **Commercial Acceptance**: Future financial performance relies heavily on the market acceptance and adoption of the Genio system by physicians, payors, and patients.
• **Additional Capital Requirements**: Significant future expenses and operating losses are expected, requiring additional capital that may not be available on favorable terms or at all, leading to potential dilution or operational restrictions.
• **Debt Covenants**: Covenants under the convertible bond instrument and EIB loan facility may accelerate indebtedness or restrict operations.
• **Loss of Subsidies**: Dependence on government subsidies, recoverable cash advances, and tax reductions, which may not continue or may have repayment obligations.
• **Financial Services Industry Instability**: Adverse developments in the financial services industry could impair access to funding or affect counterparties' ability to meet obligations.
• **Regulatory Approvals**: No guarantee of maintaining existing certifications (CE-Mark, FDA) or obtaining additional ones in other jurisdictions, or that clinical trial results will be sufficient.
• **Delayed Marketing Authorizations**: Failure or delays in receiving necessary marketing authorizations or certifications for future products.
• **Unfavorable Reimbursement**: Even with marketing authorizations, products may face unfavorable pricing regulations, third-party payor reimbursement practices, or healthcare reform initiatives.
• **Pandemic/Epidemic Impact**: Public health crises could materially affect business, financial results, and R&D/commercialization efforts.
• **Supplier Dependence**: Reliance on a limited number of single-source suppliers for critical components and services, posing risks of supply disruption, quality issues, and increased costs.
• **Manufacturing Capacity**: Inability to manufacture or outsource manufacturing in sufficient quantities, timely, or at an attractive cost.
• **Key Personnel Retention**: Inability to attract and retain management and other personnel crucial for success.
• **Third-Party Clinical Trial Reliance**: Dependence on third parties for clinical trials, data collection, and analysis, with risks of unsatisfactory performance or delays.
• **Shipping Carrier Issues**: Performance issues, service interruptions, or price increases by shipping carriers could adversely affect business.
• **Employee Misconduct**: Risk of employees, contractors, or vendors engaging in misconduct or noncompliance with regulatory standards.
• **International Operations Risks**: Exposure to economic, political, regulatory, and other risks associated with conducting business internationally, including currency fluctuations and geopolitical events.
• **Climate Change Risks**: Potential negative effects from climate change or measures to address it, including physical risks to facilities and increased operating costs.
• **Internal Control Weaknesses**: Material weaknesses in internal control over financial reporting identified, potentially leading to inaccurate financial reporting or fraud.
• **Intellectual Property Protection**: Inability to fully protect and exploit intellectual property and trade secrets, or challenges to existing IP rights.
• **Intellectual Property Litigation**: Risk of becoming subject to costly intellectual property litigation, including patent infringement claims.
• **Inadequate Patent Terms**: Patent terms may be insufficient to protect competitive position for an adequate time.
• **Dual Listing Volatility**: Dual listing on Euronext Brussels and Nasdaq Global Market may affect liquidity and value of ordinary shares due to differing market dynamics.
• **Analyst Coverage**: Lack of or unfavorable research from securities analysts could impact stock price and trading volume.
• **Short Selling**: Risk of short selling driving down the market price of ordinary shares.
• **No Dividends**: Intention to retain all earnings, meaning return on investment depends solely on share price appreciation.
• **Belgian Corporate Law Differences**: Shareholder rights under Belgian law may differ from U.S. corporate law, potentially offering less protection.
• **Dilution from Future Financings**: Future equity issuances may dilute existing shareholders.
• **Enforcement of Judgments**: Difficulty for investors outside Belgium to serve process or enforce foreign judgments against the company or its management.
• **Emerging Growth Company Status**: Reduced disclosure and governance requirements may make shares less attractive to investors.
• **Loss of Foreign Private Issuer Status**: Potential loss of foreign private issuer status could result in significant additional costs and expenses.
• **PFIC Status**: U.S. holders may suffer adverse tax consequences if the company is characterized as a Passive Foreign Investment Company (PFIC).
• **Controlled Foreign Corporation (CFC) Status**: U.S. holders owning 10% or more of shares may face adverse U.S. federal income tax consequences if non-U.S. subsidiaries are treated as CFCs.
• **Cybersecurity Threats**: Security breaches and other disruptions could compromise information, expose to liability, and harm business and reputation.
• **Healthcare Fraud and Abuse Laws**: Failure to comply with extensive healthcare fraud and abuse laws could lead to substantial penalties.
• **Healthcare Policy Changes**: Legislative or regulatory changes aiming to reform healthcare could harm business.
• **Data Privacy and Security Laws**: Failure to comply with evolving data privacy and security laws (GDPR, HIPAA, CCPA, etc.) could result in penalties and reputational harm.
• **Misuse/Off-label Use**: Misuse or off-label use of products may harm reputation, lead to liability, or regulatory sanctions.
• **Product Liability Claims**: Risk of expensive product liability claims due to inherent risks of implantable medical devices.
• **Warranty Claims**: Bearing the risk of warranty claims on the Genio system.
• **Tax on Securities Accounts**: Potential impact of Belgian annual tax on securities accounts.
• **Financial Transactions Tax (FTT)**: Potential future impact of a proposed EU FTT.

Future Outlook

Nyxoah expects continued operating losses in the foreseeable future due to investments in technology development, manufacturing expansion, sales and marketing, and regulatory clearances. The company aims to achieve profitability (positive Adjusted EBITDA) once annual revenue reaches €150 million, requiring an additional €110 million in capital. Future product generations are expected to include enhanced user experience, decreased disposable patch footprint, and cloud connectivity for remote therapy monitoring.

Management Comments

• We expect our total operating expenses to increase as we expand our sales and marketing capabilities in the United States.
• We expect to continue to incur operating losses for the foreseeable future, and we may never achieve profitability, which could impair our ability to sustain operations or obtain any required additional funding.
• Our ability to continue as a going concern will depend on our ability to obtain additional funding, as to which no assurances can be given.
• We expect that this initial class of 25 sales representatives will generate on average $1.0 million to $1.2 million in annual sales revenue per sales representative, and at full productivity, we expect a sales representative to generate over $2.0 million per year in revenue.
• Through these investments in new products and innovation, we expect to be able to increase our gross margin to over 80% once we achieve appropriate scale.
• The Board of Directors has decided that the application of the valuation rules in the assumption of a going concern is justified.
• The Company confirms that despite the recent conflict between Israel and Iran, operations are continuing with no major impact and the assets are currently safeguarded. The Company is not suffering impact of this conflict.

Industry Context

StockSavvy.ai notes that Nyxoah operates in the highly competitive medical technology industry, specifically targeting Obstructive Sleep Apnea (OSA) treatment. The market is characterized by intense competition from established players like Inspire Medical Systems, Inc., emerging neurostimulation companies such as LivaNova, and pharmaceutical companies developing drug-based therapies like GLP-1 receptor agonists (e.g., Eli Lilly's Mounjaro/Zepbound). While GLP-1s could potentially expand the pool of eligible HGNS patients by reducing BMI, they also represent a new class of direct competition. Nyxoah's focus on bilateral stimulation and MRI compatibility for its Genio system offers differentiation in a market where patient adherence to traditional CPAP therapy remains a significant challenge. The company's expansion into the U.S. market, following FDA approval, positions it against Inspire Medical's established presence, highlighting the need for strong commercialization and reimbursement strategies to capture market share.

Comparison to Industry Standards

• Nyxoah's Genio system provides bilateral hypoglossal nerve stimulation, unlike the Inspire Medical system which provides unilateral stimulation. This bilateral approach is clinically supported for treating patients with Complete Concentric Collapse (CCC), a subset contraindicated for other HGNS therapies.
• The Genio system is the first leadless, externally-powered neurostimulator, eliminating the need for additional surgical procedures for battery replacement and allowing external software/firmware updates, which contrasts with competing systems that often require internal batteries and multiple incisions.
• The Genio system is MR Conditional for full-body MRI scans at both 1.5T and 3T, a significant advantage over competing neurostimulation systems that are either MR Conditional at 1.5T only or MR Unsafe.
• The DREAM trial's 65% AHI responder rate and 76% ODI responder rate demonstrate strong clinical efficacy, comparable to or potentially exceeding results from other HGNS therapies in similar patient populations.
• The reported nightly usage of greater than four hours in over 70% of nights for 84.3% of participants in the DREAM study indicates high patient compliance, which is a critical factor for OSA therapies, especially when compared to the 29-83% non-compliance rates reported for CPAP.
• LivaNova, a competitor, announced its OSPREY clinical study met primary endpoints and expects to launch its Aura6000 device in the U.S. in 2027, indicating increasing competition in the HGNS market.
• The emergence of GLP-1 receptor agonists (e.g., Eli Lilly's Zepbound/Mounjaro) as a treatment for OSA in obese patients introduces a new class of competition, potentially impacting the HGNS market by altering patient eligibility criteria (e.g., BMI reduction).

Management Changes

Corporate Governance

Legal Proceedings

• On May 30, 2025, Inspire Medical Systems, Inc. filed a lawsuit against Nyxoah SA and Nyxoah, Inc. in the U.S. District Court for the District of Delaware, alleging infringement of three Inspire U.S. patents (Nos. 10,898,709, 11,806,526, and 11,850,424). Nyxoah has filed a counterclaim asserting non-infringement and invalidity of these patents.
• On September 15, 2025, Nyxoah filed a lawsuit against Inspire in the U.S. District Court for the District of Delaware, alleging that Inspire IV and Inspire V systems infringe three Nyxoah U.S. patents (Nos. 8,700,183, 9,415,215, and 9,415,216).
• On December 1, 2025, Nyxoah SA filed two actions against Inspire and Inspire Medical Systems Europe GmbH in the Unified Patent Court in Munich, Germany, alleging infringement of two European patents (EP 2 760 528 B1 and EP 2 760 534 B1) by the Inspire IV system.
• On December 18, 2025, Nyxoah filed petitions for inter partes review of the Inspire Asserted Patents with the U.S. Patent and Trademark Office, challenging their patentability.
• The outcome of these legal matters is inherently uncertain, and litigation could result in substantial costs, diversion of management attention, and reputational harm. The company has not accrued for potential litigation losses as of December 31, 2025, due to the early stage of litigation.

Related Party Transactions

• **Olivier Taelman (CEO)**: From September 1, 2021, until August 19, 2024, he performed his function on a self-employed basis. From August 19, 2024, until September 1, 2025, he was partially self-employed and partially an employee of Nyxoah Inc. Since September 1, 2025, he performs his function as CEO on a self-employed basis. His annual fee is €500,000 (since October 1, 2025), plus short-term and long-term incentives (warrants). He was granted 80,000 warrants under the 2024 Warrants Plan and 380,380 warrants under the 2025 Warrants Plan in 2025.
• **November 2025 Private Placement**: Robert Taub (representing Robelga SRL, Chairman of the Board), Daniel Wildman (representing Wildman Ventures LLC, director), Olivier Taelman (CEO), John Landry (CFO), and Scott Holstine (CCO) participated in the €17.0 million private placement, subscribing to ordinary shares at €4.00 per share. This participation was approved by the board under the Belgian related parties procedure.
• **May 2024 Offering**: Robert Taub (representing Robelga SRL) participated in the public offering, subscribing to ordinary shares at €8.54 per share. This participation was approved by the board under the Belgian related parties procedure.
• **Warrants to Directors and Executive Management**: Various warrants were granted to non-executive directors and executive management under the 2021, 2022, 2024, 2025, and 2025-2 Warrants Plans. Non-executive directors were granted 20,933 Restricted Share Units (RSUs) in 2025, with an exercise price of €0.1718 per share.
• **Man & Science SA**: The company entered into a collaboration agreement with Man & Science SA (a company held and governed by Robert Taub, TOGETHER Partnership, Jrgen Hambrecht and Noshaq SA) effective October 1, 2024, to develop a miniaturized injectable neuromodulation device. Nyxoah retains exclusive, royalty-free, perpetual, worldwide, transferable, and sub-licensable license for OSA.
• **Cochlear Limited**: The collaboration agreement with Cochlear Limited, dated November 2018, has ended as all work under the Statements of Work has been completed. No IP licenses were granted by Cochlear or by Nyxoah to the other party.
• **Vanderbilt University**: Nyxoah holds an exclusive worldwide license from Vanderbilt University for new neurostimulation technologies. Nyxoah paid an upfront license issue fee of approximately $650,000 and annual royalty payments of $250,000 for 2024 and 2025. Additional annual royalty payments of up to $500,000 for 2026-2027 and up to $1,000,000 for 2028 and thereafter are possible, creditable against earned royalties. Milestone payments of up to $15,750,000 are also possible, with minimums of $1,000,000 due in 2025 and 2026.

Stakeholder Impact

• **Shareholders**: Face significant dilution risk from future capital raises and warrant exercises. The dual listing may affect liquidity and value. The going concern doubt and material weaknesses in internal controls pose substantial risks to investment value. Potential for appreciation depends on successful commercialization and achieving profitability.
• **Employees**: The company is expanding its commercial organization, particularly in the U.S., creating new job opportunities. However, the closure of the Israel R&D department indicates some restructuring and potential impact on employees in that region. Share-based compensation plans aim to motivate and retain employees.
• **Customers (Physicians & Hospitals)**: Benefit from the FDA-approved Genio system as an alternative treatment for OSA, especially its bilateral stimulation and MRI compatibility. The company's focus on Centers of Excellence and training programs aims to support adoption. Reimbursement efforts are crucial for broader access.
• **Patients**: The Genio system offers a patient-centric, minimally invasive treatment option for moderate to severe OSA, including those with CCC, addressing unmet needs. Improved quality of life and high compliance rates from clinical trials are positive. However, risks associated with implantable devices and surgical procedures remain.
• **Creditors**: The company's substantial debt and going concern doubt pose risks. The convertible bonds are subordinated to the EIB facility, and payment obligations under the bond instrument may be settled in shares, impacting cash flow.
• **Suppliers**: The company relies on single-source suppliers for critical components, creating dependency and potential risks if suppliers fail to perform or discontinue supply.

Next Steps

• Complete a post-approval clinical study named BREATHE, expected to enroll 229 patients starting Q2 2026.
• Anticipate initial readout of 12-month post-implant data from the ACCCESS trial in Q3 2026.
• Continue to engage with public and private payers, providers, and relevant stakeholders to support appropriate coverage and patient access in the U.S.
• Expand the number of sales representatives in the U.S. by hiring in groups of 15 until reaching a total of 85 to cover the top 400 HGNS accounts.
• Continue investing in research and development for the next generation of the Genio system and new product pipeline.
• Further expand manufacturing capacity with a new 2,000 square meter cleanroom facility expected to be fully operational in 2027.
• Explore additional financing options, including public or private equity and debt financing, to secure the needed €110 million to reach profitability.
• Remediate identified material weaknesses in internal control over financial reporting, including further improving the internal control framework and enhancing IT general controls in Q1 2026.
• Monitor discussions and potential adoption of the European Commission's proposal for a regulation amending the MDR to simplify rules for medical devices.
• File a new shelf registration statement on Form F-3 on March 20, 2025, to register the offer and sale of up to $200.0 million of securities.
• Respond to Inspire's filings regarding inter partes review of their asserted patents by March 31, 2026.
• The Board will submit proposals for the (re)appointment of directors at the June 2026 general shareholders meeting to ensure compliance with gender diversity requirements.

Key Dates

Recommendation

Nyxoah faces significant financial challenges, including recurring and increasing operating losses, a substantial accumulated deficit, and explicit 'substantial doubt' about its ability to continue as a going concern. While FDA approval and revenue growth are positive, the need for €110 million in additional capital to reach profitability, coupled with unresolved material weaknesses in internal controls and ongoing patent litigation, presents a high-risk investment profile. The current cash runway is limited, and future financing is uncertain, making the stock a 'sell' for risk-averse investors.

Keywords

Nyxoah, Genio system, Obstructive Sleep Apnea, OSA, Hypoglossal Neurostimulation, HGNS, FDA approval, CE Mark, Medical Device, Clinical Trials, DREAM trial, ACCCESS trial, BREATHE study, Financial Results, Operating Loss, Revenue Growth, Going Concern, Internal Controls, Capital Raise, Convertible Bonds, Equity Financing, Patent Litigation, Intellectual Property, Market Expansion, Europe, United States, Belgium, Israel, Australia, Germany, United Kingdom, Switzerland, Spain, Finland, Austria, Abu Dhabi, Netherlands, Sleep Apnea Treatment, Medical Technology, Biotech, Healthcare, Regulatory Compliance, Corporate Governance, Risk Management, Financial Reporting, Share-based compensation, GLP-1, Inspire Medical Systems