PART I [Key Information](index=7&type=section&id=Item%203.%20Key%20Information) This section outlines the principal risks associated with the company's business, financial position, product development, commercialization, and regulatory compliance, including a history of losses, dependence on the Genio system's success, regulatory hurdles, and identified material weaknesses in internal financial controls [Risk Factors](index=7&type=section&id=D.%20Risk%20Factors) This subsection details the company's limited operating history, reliance on the Genio system, regulatory challenges, and internal control weaknesses - The company has a limited operating history, has incurred losses since inception, and its future performance is highly dependent on the commercial acceptance of its sole product, the Genio system[29](index=29&type=chunk) - Nyxoah has identified material weaknesses in its internal control over financial reporting for the year ended December 31, 2024, which could lead to failure in meeting reporting obligations or result in material misstatements[31](index=31&type=chunk)[288](index=288&type=chunk) - The company faces significant regulatory risks, including the need to obtain and maintain marketing authorizations in key markets like the United States, and is subject to extensive government oversight[29](index=29&type=chunk)[31](index=31&type=chunk) [Information on the Company](index=94&type=section&id=Item%204.%20Information%20on%20the%20Company) Nyxoah is a medical technology company focused on developing and commercializing the Genio system, an innovative hypoglossal neurostimulation (HGNS) therapy for Obstructive Sleep Apnea (OSA), pursuing FDA approval in the U.S. and expanding its commercial infrastructure in select European markets [History and Development of the Company](index=94&type=section&id=A.%20History%20and%20Development%20of%20the%20Company) This section traces Nyxoah's corporate history from its incorporation to its public listings and outlines its capital expenditure focus - Nyxoah SA was incorporated in Belgium on July 15, 2009, becoming publicly listed on Euronext Brussels in September 2020 and on The Nasdaq Global Market in July 2021[298](index=298&type=chunk) Capital Expenditures (in millions) | Year | Capital Expenditure (€) | | :--- | :--- | | 2024 | 5.9 million | | 2023 | 10.5 million | | 2022 | 16.3 million | - Principal capital expenditures in 2023 and 2024 were focused on capitalized development expenses, establishing a U.S. production line, and investments in new clean rooms and laboratory equipment[301](index=301&type=chunk)[302](index=302&type=chunk) [Business Overview](index=94&type=section&id=B.%20Business) This section details Nyxoah's flagship product, the Genio system, its market differentiation, and progress in clinical trials and market authorization - Nyxoah's lead product is the Genio system, a CE-Marked, minimally invasive hypoglossal neurostimulation (HGNS) therapy for moderate to severe Obstructive Sleep Apnea (OSA)[303](index=303&type=chunk) - The DREAM pivotal trial, designed to support U.S. marketing authorization, met its primary endpoints, with an announcement made on March 19, 2024, and the company expects to be commercially available in the U.S. in the first quarter of 2025[303](index=303&type=chunk)[310](index=310&type=chunk)[318](index=318&type=chunk) Estimated Annual Total Addressable Market (TAM) | Region | Target Patients | Estimated Annual Market Opportunity | | :--- | :--- | :--- | | Europe | 515,000 | ~$10 billion | | United States | 510,000 | ~$10 billion | - The Genio system is differentiated by its battery-free, leadless, single-incision implant design that provides bilateral stimulation, potentially treating a broader patient population, including those with Complete Concentric Collapse (CCC)[306](index=306&type=chunk)[308](index=308&type=chunk)[315](index=315&type=chunk) [Organizational Structure](index=160&type=section&id=C.%20Organizational%20Structure) This section outlines the company's corporate structure, including its significant subsidiaries and their respective activities Significant Subsidiaries | Name | Country | Activity | Holding | | :--- | :--- | :--- | :--- | | Nyxoah Ltd | Israel | Medical Technology R&D | 100% | | Nyxoah Pty Ltd | Australia | Medical Technology R&D | 100% | | Nyxoah, Inc. | United States | Medical Technology R&D; pre-commercialization | 100% | | Nyxoah GmbH | Germany | Commercialization of medical devices | 100% | [Property, Plant and Equipment](index=160&type=section&id=D.%20Property%2C%20Plant%20and%20Equipment) This section describes the company's property arrangements, noting that all facilities are leased across various locations - The company leases all of its properties, including its corporate headquarters in Mont-Saint-Guibert, Belgium, manufacturing facilities in Milmort, Belgium, R&D facilities in Tel Aviv, Israel, and offices in Summit, New Jersey, USA[530](index=530&type=chunk)[531](index=531&type=chunk)[532](index=532&type=chunk)[533](index=533&type=chunk)[534](index=534&type=chunk) [Operating and Financial Review and Prospects](index=161&type=section&id=Item%205.%20Operating%20and%20Financial%20Review%20and%20Prospects) Nyxoah's financial performance reflects its stage as a growing medical technology company, with revenue increasing to **€4.5 million** in 2024, but net losses widening to **€59.2 million** due to significant investments in R&D, clinical trials, and commercial infrastructure, with liquidity supported by recent capital raises expected to fund operations through mid-2026 [Operating Results](index=161&type=section&id=A.%20Operating%20Results) This section analyzes the company's financial performance, highlighting revenue growth and increased operating losses due to strategic investments - The company's financial strategy is focused on obtaining regulatory approval in new markets (especially the U.S.), growing its commercial organization, investing in clinical support and product innovation, and securing third-party payor reimbursement[540](index=540&type=chunk)[542](index=542&type=chunk)[543](index=543&type=chunk)[545](index=545&type=chunk)[546](index=546&type=chunk) Comparison of Operations (Year Ended Dec 31) | (In Thousands €) | 2024 | 2023 | YoY Change | YoY % Change | | :--- | :--- | :--- | :--- | :--- | | **Revenue** | 4,521 | 4,348 | 173 | 4% | | **Gross Profit** | 2,969 | 2,692 | 277 | 10% | | **R&D Expenses** | (34,325) | (26,651) | (7,674) | 29% | | **SG&A Expenses** | (28,461) | (21,687) | (6,774) | 31% | | **Operating Loss** | (58,809) | (45,102) | (13,707) | 30% | | **Loss for the period** | (59,236) | (43,212) | (16,024) | 37% | - Revenue for 2024 increased by **4% to €4.5 million**, driven by growing commercialization of the Genio system in Europe, including expansion into Italy and the UK[561](index=561&type=chunk) - The operating loss widened by **30% in 2024**, primarily due to a **€7.6 million (29%) increase in R&D expenses** and a **€6.8 million (31%) increase in SG&A expenses** to support clinical trials, product development, and commercial scale-up[564](index=564&type=chunk)[571](index=571&type=chunk)[576](index=576&type=chunk) [Liquidity and Capital Resources](index=174&type=section&id=B.%20Liquidity%20and%20Capital%20Resources) This section details the company's cash position, capital raises, and projected liquidity runway - As of December 31, 2024, the company had cash and cash equivalents of **€34.2 million** and financial assets of **€51.4 million**[600](index=600&type=chunk) - The company believes its current cash position is sufficient to fund operations for at least 12 months from the report date and through the middle of 2026, supported by capital raises totaling **€110.6 million in 2024**[550](index=550&type=chunk)[600](index=600&type=chunk)[612](index=612&type=chunk) Cash Flow Summary (Year Ended Dec 31, in thousands €) | Cash Flow Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | (49,226) | (44,778) | | Net cash from (used in) investing activities | (16,325) | 32,011 | | Net cash from financing activities | 77,439 | 16,858 | [Directors, Senior Management and Employees](index=178&type=section&id=Item%206.%20Directors%2C%20Senior%20Management%20and%20Employees) This section details the composition of the company's leadership and workforce, providing biographies for executive officers and non-executive directors, outlining compensation structure, and describing board practices and committee compositions, with a significant increase in personnel to support R&D and commercial activities as of year-end 2024 [Directors and Senior Management](index=178&type=section&id=A.%20Directors%20and%20Senior%20Management) This section introduces the executive team and non-executive board members, highlighting key leadership changes and their expertise - The executive team is led by CEO Olivier Taelman, with key additions and changes in 2024 including John Landry as CFO (replacing Loic Moreau) and Scott Holstine as CCO[618](index=618&type=chunk)[619](index=619&type=chunk)[620](index=620&type=chunk)[622](index=622&type=chunk) - The non-executive board is chaired by founder Robert Taub (represented by Robelga SRL) and includes members with extensive experience in life sciences, medical devices, and finance from companies like HighCape Capital, Cochlear, and BASF[618](index=618&type=chunk)[623](index=623&type=chunk)[624](index=624&type=chunk)[626](index=626&type=chunk) [Compensation](index=181&type=section&id=B.%20Compensation) This section details the compensation structure for the CEO, executive management, and non-executive directors, including salaries, bonuses, and equity awards CEO Compensation (2024) | Component | Amount (€) | | :--- | :--- | | Base salary | 424,283 | | Performance bonus | 298,029 | | Pension contributions | 19,860 | | Fringe benefits | 18,381 | - In 2024, CEO Olivier Taelman was granted **420,000 warrants**, while other executive management team members received an aggregate base salary of **€693,546** and performance bonuses of **€348,138**[650](index=650&type=chunk)[651](index=651&type=chunk) - Non-executive directors receive an annual fixed fee (**€45,000** for directors, **€82,000** for the Chairman) plus additional fees for committee service, and in 2024, all non-executive directors were also granted **14,806 Restricted Share Units (RSUs)** each[634](index=634&type=chunk)[636](index=636&type=chunk) [Board Practices](index=193&type=section&id=C.%20Board%20Practices) This section describes the company's governance structure, board committees, and deviations from Nasdaq listing rules as a foreign private issuer - The company has a one-tier governance structure and has established four board committees: Audit, Remuneration, Nomination, and Science & Technology[670](index=670&type=chunk)[679](index=679&type=chunk) - As a foreign private issuer, Nyxoah follows certain Belgian corporate governance practices in lieu of Nasdaq requirements, such as not having a majority of independent directors on the full board and different composition rules for its Remuneration and Nomination committees[666](index=666&type=chunk)[882](index=882&type=chunk) - The company deviates from the Belgian Corporate Governance Code by granting share-based incentives (warrants and RSUs) to non-executive directors, arguing it is necessary to attract top talent in the life sciences industry and align their interests with shareholders[698](index=698&type=chunk) [Employees](index=202&type=section&id=D.%20Employees) This section provides an overview of the company's workforce size and its growth across different functions Full-Time Equivalents (FTEs) by Function | Function | 2024 | 2023 | 2022 | | :--- | :--- | :--- | :--- | | Sales, General & Administration | 56.5 | 40.4 | 34.9 | | Research & Development | 127.1 | 106.4 | 102.6 | | **Total** | **183.6** | **146.8** | **137.5** | - The company's workforce grew to **183.6 FTEs in 2024** from **146.8 in 2023**, with significant growth in both R&D and SG&A functions to support clinical trials and commercial expansion[701](index=701&type=chunk) [Major Shareholders and Related Party Transactions](index=204&type=section&id=Item%207.%20Major%20Shareholders%20and%20Related%20Party%20Transactions) This section identifies the company's major shareholders, with significant stakes held by Cochlear Investments Pty Ltd (**15.1%**), founder Robert Taub (**10.7%**), Vestal Point Capital, LP (**8.0%**), and entities affiliated with Gilde Healthcare (**7.8%**), and details related party transactions, including compensation for directors and executives [Major Shareholders](index=204&type=section&id=A.%20Major%20Shareholders) This section lists the company's principal shareholders and their respective ownership percentages Beneficial Ownership (as of March 1, 2025) | Shareholder | Ownership % | | :--- | :--- | | Cochlear Investments Pty Ltd | 15.1% | | Robert Taub | 10.7% | | Vestal Point Capital, LP | 8.0% | | TOGETHER Partnership | 7.9% | | Entities affiliated with Gilde Healthcare | 7.8% | | Resmed Inc. | 4.6% | | FMR LLC | 4.5% | | Jürgen Hambrecht | 3.7% | - As of March 1, 2025, all current directors and executive management as a group beneficially own **17.0%** of the company's ordinary shares[710](index=710&type=chunk) [Related Party Transactions](index=207&type=section&id=B.%20Related%20Party%20Transactions) This section outlines transactions with related parties, including executive compensation and board member participation in offerings - CEO Olivier Taelman performs his duties under a service agreement and, as of August 2024, also as an employee of Nyxoah Inc. following a temporary relocation to the U.S[717](index=717&type=chunk)[718](index=718&type=chunk) - Board Chairman Robert Taub participated in the May 2024 underwritten public offering, an action approved by the board under the related parties procedure[719](index=719&type=chunk) [Financial Information](index=209&type=section&id=Item%208.%20Financial%20Information) This section confirms that the detailed consolidated financial statements are provided elsewhere in the report, states that the company has never paid dividends and does not anticipate doing so, intending to retain all earnings for business operation and expansion, and notes no significant changes have occurred since the balance sheet date of December 31, 2024 - The company has never declared or paid cash dividends and does not intend to in the foreseeable future, retaining all funds for business expansion[723](index=723&type=chunk) - Dividend distributions are subject to Belgian law, requiring sufficient distributable profits and the allocation of **5% of annual net profit** to a legal reserve until it reaches **10% of share capital**[724](index=724&type=chunk)[725](index=725&type=chunk) - There have been no significant changes to the company's financial condition since December 31, 2024[726](index=726&type=chunk) [Additional Information](index=213&type=section&id=Item%2010.%20Additional%20Information) This section covers key corporate and tax information, confirming no material contracts outside the ordinary course of business and no Belgian exchange controls limiting payments to U.S. residents, and providing a detailed summary of material U.S. and Belgian tax considerations for shareholders, including potential PFIC classification and the **30%** Belgian withholding tax on dividends [Taxation](index=213&type=section&id=E.%20Taxation) This section provides an overview of U.S. and Belgian tax implications for shareholders, including PFIC status and dividend withholding tax - For U.S. holders, the company does not expect to be classified as a Passive Foreign Investment Company (PFIC) for the current taxable year, but this is an annual determination and cannot be assured[256](index=256&type=chunk)[754](index=754&type=chunk) - Dividends paid by the company are generally subject to a **30% Belgian withholding tax**, which may be reduced under applicable tax treaties, such as the U.S.-Belgium Tax Treaty[768](index=768&type=chunk)[795](index=795&type=chunk) - A Belgian tax on stock exchange transactions of **0.35%** (capped at **€1,600 per transaction**) applies to the sale and purchase of shares on the secondary market if carried out through a Belgian intermediary or by a Belgian investor[811](index=811&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=237&type=section&id=Item%2011.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks are foreign exchange risk and credit risk, with credit risk considered low, and foreign exchange risk stemming from expenses denominated in USD, NIS, and AUD, where a **5%** strengthening of the USD against the Euro in 2024 would have increased the net loss by **€87,000**, and the company does not currently hedge its currency risk exposure - The company's main market risks are credit risk and foreign exchange risk, with credit risk considered minimal as it arises from reputable institutions and governments[846](index=846&type=chunk)[847](index=847&type=chunk) - Foreign exchange risk is primarily from expenses in U.S. dollars (USD), Israeli new shekel (NIS), and Australian dollars (AUD), and the company does not generally hedge this exposure[848](index=848&type=chunk)[850](index=850&type=chunk) Foreign Exchange Risk Sensitivity (2024) | Currency Change vs. Euro | Impact on Net Loss (€) | | :--- | :--- | | +5% USD Strength | €87,000 higher | | -5% USD Strength | €79,000 lower | | +5% NIS Strength | €35,000 higher | | -5% NIS Strength | €32,000 lower | | +5% AUD Strength | €22,000 higher | | -5% AUD Strength | €20,000 lower | PART II [Controls and Procedures](index=240&type=section&id=Item%2015.%20Controls%20and%20Procedures) Management concluded that as of December 31, 2024, the company's disclosure controls and procedures and its internal control over financial reporting were not effective due to continued material weaknesses related to insufficient accounting personnel and inadequate documentation of control procedures, with remediation efforts underway but not complete by year-end - Management concluded that disclosure controls and procedures were not effective as of December 31, 2024, due to ongoing material weaknesses in internal control over financial reporting[862](index=862&type=chunk) - Material weaknesses identified relate to: 1) Insufficient accounting and supervisory personnel with the appropriate technical experience and training 2) Insufficient documented evidence of control procedures, including IT General Controls, preventing validation of their operating effectiveness[865](index=865&type=chunk)[866](index=866&type=chunk) - Remediation actions are in progress, including formalizing a risk assessment, designing an internal control framework within a GRC tool, and engaging an external advisor to validate design effectiveness, however, these efforts had not fully resolved the weaknesses by year-end[866](index=866&type=chunk)[867](index=867&type=chunk)[871](index=871&type=chunk) - Despite the material weaknesses, management believes the consolidated financial statements for the period are fairly presented in all material respects[869](index=869&type=chunk) [Other Information](index=243&type=section&id=Item%2016.%20Other%20Information) This section covers various governance and compliance topics, identifying Kevin Rakin as the Audit Committee Financial Expert, confirming the adoption of a Code of Ethics, detailing principal accountant fees to EY totaling **€758,000** in 2024, outlining the company's adherence to Belgian governance practices as a foreign private issuer, and describing its board-overseen cybersecurity risk management strategy, with no material cybersecurity incidents reported [Principal Accountant Fees and Services](index=244&type=section&id=Item%2016C.%20Principal%20Accountant%20Fees%20and%20Services) This section details the fees paid to the principal accountant, EY, for audit and tax services Accountant Fees (in thousands €) | Fee Type | 2024 | 2023 | | :--- | :--- | :--- | | Audit Fees | 748 | 526 | | Tax Fees | 10 | 20 | | **Total** | **758** | **546** | - All services provided by the principal accountant, EY, were pre-approved by the Audit Committee[877](index=877&type=chunk) [Corporate Governance](index=244&type=section&id=Item%2016G.%20Corporate%20Governance) This section explains how the company, as a foreign private issuer, aligns its corporate governance with Belgian practices rather than certain Nasdaq rules - As a foreign private issuer, the company follows Belgian corporate governance practices in lieu of certain Nasdaq listing rules, including those related to shareholder meeting quorum, compensation/nomination committee composition, and the requirement for a majority of independent directors on the board[881](index=881&type=chunk)[882](index=882&type=chunk) [Cybersecurity](index=247&type=section&id=Item%2016K.%20Cybersecurity) This section outlines the company's cybersecurity risk management strategy, board oversight, and confirms no material incidents - The company's cybersecurity program is based on recognized frameworks like NIST and is overseen by the Board of Directors, with day-to-day management led by the Chief Financial Officer[885](index=885&type=chunk)[891](index=891&type=chunk)[893](index=893&type=chunk) - The company's strategy includes regular monitoring, vulnerability assessments, employee training, and an incident response plan to manage cybersecurity threats[886](index=886&type=chunk)[887](index=887&type=chunk) - The company has not experienced any material cybersecurity incidents, and related expenses have been immaterial[890](index=890&type=chunk) PART III [Financial Statements](index=249&type=section&id=Item%2018.%20Financial%20Statements) The consolidated financial statements for Nyxoah SA cover the three years ended December 31, 2024, showing total assets grew to **€158.4 million** in 2024 from **€124.2 million** in 2023, primarily funded by increased equity from capital raises, with a net loss of **€59.2 million** for 2024, widening from a **€43.2 million** loss in 2023 due to increased R&D and SG&A spending, and significant cash used in operations (**€49.2 million**) and investing activities (**€16.3 million**) offset by **€77.4 million** from financing activities Consolidated Balance Sheet Highlights (in thousands €) | Account | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Total Assets** | **158,406** | **124,157** | | Cash and cash equivalents | 34,186 | 21,610 | | Financial assets | 51,369 | 36,138 | | Intangible assets | 50,381 | 46,608 | | **Total Liabilities** | **45,152** | **26,135** | | **Total Equity** | **113,254** | **98,022** | Consolidated Statement of Loss Highlights (in thousands €) | Account | 2024 | 2023 | 2022 | | :--- | :--- | :--- | :--- | | Revenue | 4,521 | 4,348 | 3,084 | | Gross profit | 2,969 | 2,692 | 1,934 | | Operating loss | (58,809) | (45,102) | (32,499) | | **Loss for the period** | **(59,236)** | **(43,212)** | **(31,225)** | Consolidated Statement of Cash Flow Highlights (in thousands €) | Account | 2024 | 2023 | 2022 | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | (49,226) | (44,778) | (28,756) | | Net cash from / (used in) investing activities | (16,325) | 32,011 | (89,946) | | Net cash from financing activities | 77,439 | 16,858 | (983) | [Exhibits](index=249&type=section&id=Item%2019.%20Exhibits) This section lists all exhibits filed as part of the annual report, including the company's Articles of Association, material contracts such as the Cochlear Collaboration Agreement and the EIB Loan Facility Agreement, various warrant plans, certifications by the CEO and CFO, and the consent of the independent registered public accounting firm - Key exhibits filed include the Articles of Association, Description of Securities, various material contracts (Cochlear, Man & Science, EIB), and multiple warrant plans (2020, 2021, 2022, 2024)[898](index=898&type=chunk)[900](index=900&type=chunk) - Certifications from the Chief Executive Officer and Chief Financial Officer pursuant to Sarbanes-Oxley Act Sections 302 and 906 are included as exhibits[900](index=900&type=chunk)

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][28] - 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 in the U.S. [28] - Cash position improved to €85.6 million at the end of 2024, up from €57.7 million at the end of 2023 [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 increased by 18% to €5.1 million compared to 2023 [23] Market Data and Key Metrics Changes - The company launched Genio in the UK and UAE, with the UK expected to become one of the largest international markets 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 developing referral networks with sleep physicians [17][19] - A two-pronged strategy will be employed for market penetration, targeting both existing HGNS centers and sleep physicians managing OSA patients [17][19] - The company plans to utilize CPT code 64568 for reimbursement, which is recognized by commercial and government payers for OSA indications [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in receiving FDA approval by the end of March 2025, with ongoing discussions focused on labeling [31][50] - The company anticipates significant growth in 2025, with a focus on U.S. market entry and further international expansion [32][30] Other Important Information - The DREAM study demonstrated 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][12] - Genio's safety profile showed an 8.7% severe adverse event rate, which is expected to positively influence therapy selection by physicians [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 [36][38] Question: Trajectory of U.S. launch and account openings - Management indicated that they are targeting approximately 300 to 350 high-volume HGNS sites for initial account openings, with plans to scale up quarterly [40][44] Question: Confidence in FDA approval timeline - Management remains confident in the March approval timeline, citing a 90-day review clock and positive interactions with the FDA [49][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 [63][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 clinical and economic justification [70][71] Question: Key differentiators for Genio versus competitors - Management highlighted the benefits of bilateral stimulation and the ability to upgrade the system without additional surgery as key differentiators [78][80] Question: Timing of DREAM publication and ACCCESS enrollment - Management expects the DREAM study publication in a leading medical journal in the coming months and anticipates completing ACCCESS enrollment by mid-2025 [83][84]

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]

Nyxoah SA (NYXH) came out with a quarterly loss of $0.49 per share versus the Zacks Consensus Estimate of a loss of $0.50. This compares to loss of $0.41 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 2%. A quarter ago, it was expected that this company would post a loss of $0.46 per share when it actually produced a loss of $0.55, delivering a surprise of -19.57%.Over the last four quarters, the company has surpassed consens ...

Core Insights - Nyxoah reported financial and operational results for Q4 and FY 2024, highlighting a transformative year with significant advancements in their product and market strategy [1][3][4] Financial Performance - Q4 2024 revenue was €1.3 million, with deferred revenue accounting for €0.6 million; without this deferral, revenue would have been €1.9 million, a 46% increase from Q3 2024 [4] - Full year 2024 revenue reached €4.5 million, an 18% increase from €4.3 million in 2023, driven by the commercialization of the Genio® system, particularly in Germany [4] - Gross profit for Q4 2024 was €0.9 million, resulting in a gross margin of 73%, compared to a gross margin of 60% in Q4 2023 [5][6] - Total operating loss for Q4 2024 was €18.3 million, up from €10.8 million in Q4 2023, primarily due to increased R&D and commercial expenses [10] Research and Development - R&D expenses for Q4 2024 were €11.7 million, compared to €7.3 million in Q4 2023; for the full year, R&D expenses totaled €34.3 million, up from €26.7 million in 2023 [7] Selling, General and Administrative Expenses - Selling, general and administrative expenses for Q4 2024 were €8.1 million, an increase from €4.9 million in Q4 2023; for the full year, these expenses were €28.5 million, compared to €21.7 million in 2023 [8][9] Cash Position - As of December 31, 2024, cash and financial assets totaled €85.6 million, an increase from €57.7 million at the end of 2023 [11] Market Position and Future Outlook - The company is positioned for a U.S. commercial launch of the Genio® system in March 2025, with FDA approval expected by the end of Q1 2025 [1][3]

REGULATED INFORMATION Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating ResultsFDA PMA Application Review Nearing ConclusionPositioned for U.S. Commercial Launch in March 2025 Mont-Saint-Guibert, Belgium – March 13, 2024, 7:00am CET / 2:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the "Company"), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the f ...

Nyxoah to Release Fourth Quarter and Financial Year 2024 Financial Results on March 13, 2025 Mont-Saint-Guibert, Belgium – Monday, March 10, 2025, 10:05pm CET / 5:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the Company will release financial results for the fourth quarter and financial year 2024 on Thursday, March 13, 2025. Company management ...

Core Insights - Nyxoah will participate in the Oppenheimer 35 Annual Healthcare MedTech & Services Conference from March 17 to 20, 2025 [1] - CEO Olivier Taelman will present on March 17, 2025, at 8:40am ET, with a webcast available for investors [2] - The company focuses on innovative treatments for Obstructive Sleep Apnea (OSA) through neuromodulation [3] Company Overview - Nyxoah develops breakthrough treatment alternatives for OSA, with its first product being the Genio® device, which is battery-free and inserted through a single incision [3] - The Genio® system received its European CE Mark in 2019 after the successful BLAST OSA study [4] - The company has completed two IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [4] - Following positive outcomes from the BETTER SLEEP study, Nyxoah expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients [4] - The company also announced positive results from the DREAM IDE pivotal study, which is aimed at FDA and U.S. commercialization approval [4]

Core Insights - Nyxoah has announced the commercial launch of its Genio system in the Middle East, with the first successful implant performed at Saudi German Hospital in Dubai [1][2] - The Genio system is a breakthrough therapy for Obstructive Sleep Apnea (OSA) that utilizes neuromodulation and is designed for patients who cannot tolerate CPAP [2][3] - The launch represents a historic milestone as the first neurostimulation therapy for OSA in the region, aiming to expand access and transform treatment options for patients [2][4] Company Overview - Nyxoah is a medical technology company focused on developing innovative treatment alternatives for OSA through neuromodulation [3] - The Genio device is a battery-free hypoglossal neuromodulation system that is inserted through a single incision and controlled by a wearable device [3] - The company has demonstrated best-in-class outcomes for reducing the burden of OSA through its commitment to innovation and clinical evidence [3] Regulatory and Market Developments - 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, first on Euronext Brussels in September 2020 and then on NASDAQ in July 2021 [4] - The company has received CE mark approval for expanding therapeutic indications to patients with Complete Concentric Collapse (CCC), which are currently contraindicated in competitors' therapies [4]

Core Insights - Nyxoah has announced the commercial launch of its Genio® system in the Middle East, with the first successful implantation performed at Saudi German Hospital in Dubai [1][6] - Genio is a neuromodulation device designed to treat Obstructive Sleep Apnea (OSA) for patients who cannot tolerate CPAP therapy, marking a significant advancement in treatment options [1][2] - The launch in the UAE represents a historic milestone as the first neurostimulation therapy for OSA in the region, with strong clinical evidence supporting its effectiveness [1][3] Company Overview - Nyxoah is focused on developing innovative treatment alternatives for OSA through neuromodulation, with Genio being its flagship product [2] - The Genio device is battery-free and is inserted through a single incision under the chin, controlled by a wearable device, showcasing the company's commitment to patient-centric solutions [2] - The company has received CE Mark approval for Genio in Europe and is pursuing FDA approval for commercialization in the U.S. following successful clinical studies [3]