Nyxoah Conference Call Summary Company Overview - **Company**: Nyxoah - **Industry**: Medical Technology, specifically focused on obstructive sleep apnea (OSA) treatment Key Points and Arguments Innovative Technology - Nyxoah offers a next-generation neuromodulation solution for moderate to severe OSA patients, utilizing hypoglossal nerve stimulation with bilateral stimulation and single-incision implants [3][4] - The system is designed to be fully MRI compatible and does not require an implantable battery, eliminating the need for re-surgery when the battery is depleted or when software upgrades are needed [3][4] Clinical Evidence and DREAM Study - The DREAM pivotal study aimed to reduce the apnea-hypopnea index (AHI) by at least 50% and bring the overall number of events below 20 [5][6] - The study reported a severe obstructive event percentage of 8.7%, significantly lower than the competition's nearly 20% [6] - Median reduction in AHI was reported at 70%, with 82% of participants achieving an AHI below 15, which is a critical threshold for treatment eligibility [8][9] FDA Approval and Market Entry - Nyxoah received FDA approval on August 8, allowing the company to launch its product in the U.S. market [10][11] - The approval includes specific indications for patients with extreme difficult airway openings, which are contraindicated for current AGNS technology [10][11] Commercial Strategy - The company has a two-pronged launch strategy targeting both sleep physicians and ENT surgeons, emphasizing the role of sleep physicians in patient management [15][17] - Nyxoah has already trained over 100 physicians and aims to expand its commercial team to increase market penetration [13][36] Market Penetration and Competition - Nyxoah aims to capture high-volume implanting sites, with a goal of reaching 400 sites that represent 80% of the total volume in the U.S. [18][20] - The company has successfully captured a 25% market share in Germany within two years and aims to replicate this success in the U.S. [20][21] Reimbursement Strategy - Nyxoah is actively working with payers to ensure reimbursement for its technology, leveraging existing CPT codes and engaging with major commercial payers [22][23] - The company has received positive feedback from Medicare regarding coding acceptance, which is crucial for scaling up operations [23][24] Future Innovations and R&D - Nyxoah is focused on continuous innovation, including developing a more intelligent implantable device and a wearable component that provides real-time feedback to patients [44][45] - The company is exploring the potential for a pillow charging concept for its devices, aiming for a seamless user experience [45][49] Patient Profile and Market Trends - The ideal patient profile for Nyxoah's treatment includes individuals aged around 53-54 who are health-conscious and motivated to maintain a healthy lifestyle [29][30] - The emergence of GLP-1 therapeutics may expand the patient pool by enabling weight loss in individuals with higher BMIs, which could lead to increased demand for Nyxoah's technology [33][35] Access Trial and Clinical Validation - The ACCESS trial aims to validate the effectiveness of Nyxoah's technology for patients with complete concentric collapse (CCC), with a submission for label expansion expected by Q1 2027 [50][52] Differentiation and Manufacturing - Nyxoah emphasizes the differentiation of its technology through bilateral stimulation and the scalability of its platform, which is designed to benefit patients significantly [54][55] Additional Important Insights - The company has made strategic decisions to manufacture in the U.S. for the U.S. market, which is seen as a beneficial move given current market dynamics [54]

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

Core Insights - Nyxoah is a medical technology company focused on developing innovative treatments for Obstructive Sleep Apnea (OSA) [4] - The company will participate in several investor events in September 2025, including the Wells Fargo Healthcare Conference and the Morgan Stanley Annual Global Healthcare Conference [2][3] Company Overview - Nyxoah's primary product is the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy for OSA, a condition linked to increased mortality and cardiovascular issues [4] - The Genio system received its European CE Mark in 2019 after the successful completion of the BLAST OSA study [5] - The company 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, Nyxoah 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]

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

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was €1,300,000, an increase of 73.8% compared to €800,000 in Q2 2024 [16] - Gross margin for Q2 2025 was 63.4%, essentially flat compared to the previous year [16] - Total operating loss for Q2 2025 was $19,900,000, up from $13,300,000 in Q2 2024, driven by increased commercial investments in the U.S. [16][17] - Cash position as of June 30, 2025, was €43,000,000, down from €63,000,000 at March 31, 2025 [17] Business Line Data and Key Metrics Changes - The GENIOR system received FDA PMA approval, marking a significant advancement in treatment options for obstructive sleep apnea (OSA) patients in the U.S. [5][6] - The device demonstrated a compliance rate of 85.9% and a patient satisfaction score of 90% [10] Market Data and Key Metrics Changes - The U.S. market for OSA treatment is concentrated, with approximately 1,400 implanting accounts, of which 350 to 400 are high-volume accounts representing 75% to 80% of total revenue [34][35] - The company has identified demand from patients hesitant about receiving implanted batteries, which the GENIOR system addresses with its unique design [13] Company Strategy and Development Direction - The company has a two-pronged launch strategy targeting high-volume hypoglossal neurostimulation implanting centers and developing strong referral networks with physicians managing large populations of OSA patients [11][36] - The company aims to differentiate itself through its unique technology benefits and patient focus, particularly in the context of competition with GLP-1 treatments [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the success of the U.S. launch, citing enthusiastic responses from physicians and patients [19] - The remainder of 2025 is expected to be transformative as the company establishes GENIOR in the U.S. market [20] Other Important Information - The company has stopped enrollment in the ACCESS study, believing that the current number of patients enrolled is sufficient for meaningful conclusions [8] - A patent lawsuit initiated by Inspire Medical against the company will not impact the U.S. commercial launch [15] Q&A Session Summary Question: Year-end 2025 metrics and indicators to focus on - Management will track the number of trained physicians and value analysis committee applications as leading indicators [22][24] Question: Leveraging the differentiated label - The company plans to capitalize on the label differentiation by emphasizing the ability to treat positional OSA and the lack of contraindication for complete concentric collapse (CCC) patients [26][28] Question: Commercial strategy and targeted accounts - The sales team will focus on high-volume implanting accounts, which represent a significant portion of revenue [34][35] Question: Reimbursement strategy and payer onboarding - The company expects to see pre-authorization decisions coming in this year, while coverage decisions may be more of a 2026 story [41][42] Question: Access trial and CCC patient treatment - The company will not promote off-label indications but is optimistic about treating CCC patients once the ACCESS trial data is available [69][71] Question: Pricing strategy - The company intends to follow the same pricing strategy as competitors, pricing at approximately $25,000 [74] Question: Initial surgeon engagement and market share - Surgeons must present five defined patient cases before being trained, and the company does not set specific market share expectations at this stage [77][79]

[Business Update](index=2&type=section&id=1.%20BUSINESS%20UPDATE) The company provides updates on clinical trials for the Genio® system and its European commercialization progress [Clinical Update](index=2&type=section&id=A.%20CLINICAL%20UPDATE) The company successfully completed the DREAM IDE pivotal study, receiving FDA marketing approval for the Genio® system, and achieved primary endpoints in the BETTER SLEEP trial - The DREAM study met its primary endpoints with an Apnea-Hypopnea Index (AHI) responder rate of **63.5%** (p=0.002) and an Oxygen Desaturation Index (ODI) responder rate of **71.3%** (p<0.001)[8](index=8&type=chunk) - The study demonstrated a median 12-month AHI reduction of **70.8%**[8](index=8&type=chunk) - On August 8, 2025, the company received **FDA marketing approval** for its Genio® system, enabling commercial launch in the United States[9](index=9&type=chunk) - The BETTER SLEEP trial achieved its primary endpoint in both CCC and non-CCC patient cohorts, with an overall statistically significant **11-point reduction in AHI4** (p<0.001)[12](index=12&type=chunk) - Data from the BETTER SLEEP study was used to expand the company's **CE mark** for the Genio® system to treat patients demonstrating CCC at the soft palate level[16](index=16&type=chunk) - The FDA granted **Breakthrough Device Designation** for the Genio® system in September 2021 to shorten the approval path for treating CCC patients in the U.S., and the IDE application for the ACCCESS study was approved in July 2022[17](index=17&type=chunk) [European Commercialization](index=4&type=section&id=B.%20EUROPEAN%20COMMERCIALIZATION) The company generated **2.4 million EUR** in H1 2025 from European commercialization, expanding into new markets like the UK and Middle East Revenue from European Commercialization | Period | Revenue (million EUR) | | :----- | :-------------------- | | Q2 2025 | 1.3 | | H1 2025 | 2.4 | - The company's commercial strategy focuses on creating a **Center of Excellence ecosystem** with high clinical expertise[20](index=20&type=chunk) - Nyxoah entered the SSDP with the NHS in the UK in Q4 2024 and initiated commercialization in the Middle East region (Dubai, Kuwait, Abu Dhabi) in Q1 2025 and Q2 2025[20](index=20&type=chunk) [Financial Highlights](index=6&type=section&id=2.%20FINANCIAL%20HIGHLIGHTS) The company experienced revenue growth but a significant increase in operating expenses, leading to a larger net loss and reduced cash position [Key Financial Performance](index=6&type=section&id=2.1%20Key%20Financial%20Performance) For the first half of 2025, Nyxoah experienced revenue growth but also a significant increase in operating expenses, leading to a larger net loss and reduced cash position Key Financial Highlights (Six Months Ended June 30) | Metric | H1 2025 (million EUR) | H1 2024 (million EUR) | Change (YoY) | | :------------------------------------ | :-------------------- | :-------------------- | :----------- | | Revenue | 2.4 | 2.0 | +0.4 (+20%) | | Cost of goods sold | 0.9 | 0.7 | +0.2 (+28.6%) | | Selling, general and administrative expenses | 23.1 | 12.4 | +10.7 (+86.7%) | | Research and development expenses (before capitalization) | 20.6 | 18.0 | +2.6 (+14.7%) | | Net financial result | (2.1) | 1.0 | -3.1 | | Net loss | (43.0) | (25.0) | -18.0 | | Cash and cash equivalents and financial assets (as of June 30/Dec 31) | 43.0 (June 30, 2025) | 85.6 (Dec 31, 2024) | -42.6 | - The increase in Selling, General and Administrative expenses was primarily due to costs supporting the **commercialization of the Genio® system** and scale-up preparations for the U.S. market following FDA approval[22](index=22&type=chunk) - The net negative financial result was mainly driven by the **exchange rate depreciation of the U.S. dollar versus the Euro** and interest expense on the term loan entered into in July 2024[24](index=24&type=chunk) [2025 Outlook](index=6&type=section&id=3.%202025%20OUTLOOK) The company anticipates continued sales growth in Germany and other European and Middle Eastern markets, contingent on favorable reimbursement, and expects U.S. commercial launch following recent FDA approval [Commercialization and Market Expansion](index=6&type=section&id=3.1%20Commercialization%20and%20Market%20Expansion) The company anticipates continued sales growth in Germany and other European and Middle Eastern markets, contingent on favorable reimbursement. The recent FDA marketing approval for the Genio® system on August 8, 2025, is expected to enable its commercial launch in the United States - The company expects to continue ramping up sales in Germany and other European countries, as well as in select European and Middle East markets, subject to **favorable reimbursement**[27](index=27&type=chunk) - **FDA marketing approval** for the Genio® system was received on August 8, 2025, enabling its commercial launch in the United States[27](index=27&type=chunk) [Risk Factors](index=7&type=section&id=4.%20RISK%20FACTORS) This section refers to the 2024 annual report for a detailed description of principal risks, covering financial, operational, and regulatory aspects [Overview of Principal Risks](index=7&type=section&id=4.1%20Overview%20of%20Principal%20Risks) The company refers to its 2024 annual report for a detailed description of risk factors, which broadly cover financial stability, product development, market commercialization, operational dependencies, and legal/regulatory compliance - Principal risks and uncertainties include the company's financial situation and need for additional capital, clinical development of product candidates, commercialization and reimbursement, dependence on third parties and key personnel, market and country operations, manufacturing, legal and regulatory compliance, intellectual property, and organization and operations[29](index=29&type=chunk) [Forward-Looking Statements](index=7&type=section&id=5.%20FORWARD-LOOKING%20STATEMENTS) This section cautions that the report contains forward-looking statements subject to inherent risks and uncertainties, with no obligation to update unless legally required [Nature and Cautionary Note](index=7&type=section&id=5.1%20Nature%20and%20Cautionary%20Note) This section highlights that the report contains forward-looking statements, which are subject to inherent risks and uncertainties. Readers are advised against undue reliance on these statements, and the company disclaims any obligation to update them unless legally mandated - Forward-looking statements are identified by words such as 'anticipate,' 'believe,' 'expect,' and 'plan,' and involve **inherent risks and uncertainties**[30](index=30&type=chunk) - Actual results may differ materially due to factors including competitive developments, clinical trial and product development activities, regulatory approval requirements, reliance on third-party collaborations, commercial potential estimation, intellectual property protection, limited operating history, and ability to obtain additional funding[30](index=30&type=chunk) - The company expressly disclaims any obligation to update forward-looking statements unless specifically required by applicable law or regulation[30](index=30&type=chunk) [Unaudited Condensed Consolidated Interim Financial Information](index=8&type=section&id=UNAUDITED%20CONDENSED%20CONSOLIDATED%20INTERIM%20FINANCIAL%20INFORMATION%20AS%20AT%20AND%20FOR%20THE%20SIX%20MONTHS%20ENDED%20JUNE%2030%2C%202025) This section presents the unaudited condensed consolidated interim financial statements, including the statement of financial position, loss, equity changes, and cash flows [Interim Consolidated Statement of Financial Position](index=8&type=section&id=INTERIM%20CONSOLIDATED%20STATEMENT%20OF%20FINANCIAL%20POSITION) The company's financial position as of June 30, 2025, shows a decrease in total assets and total equity compared to December 31, 2024, while total liabilities remained relatively stable Consolidated Statement of Financial Position (in thousand EUR) | Item | June 30, 2025 (thousand EUR) | December 31, 2024 (thousand EUR) | Change (thousand EUR) | | :--------------------------------- | :--------------------------- | :--------------------------- | :-------------------- | | **ASSETS** | | | | | Non-current assets | 61,356 | 60,323 | +1,033 | | Current assets | 55,114 | 98,083 | -42,969 | | **Total assets** | **116,470** | **158,406** | **-41,936** | | **EQUITY AND LIABILITIES** | | | | | Total equity attributable to shareholders | 73,397 | 113,254 | -39,857 | | Non-current liabilities | 22,127 | 23,623 | -1,496 | | Current liabilities | 20,946 | 21,529 | -583 | | **Total liabilities** | **43,073** | **45,152** | **-2,079** | | **Total equity and liabilities** | **116,470** | **158,406** | **-41,936** | [Interim Consolidated Statements of Loss and Other Comprehensive Loss](index=9&type=section&id=INTERIM%20CONSOLIDATED%20STATEMENTS%20OF%20LOSS%20AND%20OTHER%20COMPREHENSIVE%20LOSS) For the three and six months ended June 30, 2025, the company reported increased revenue but also significantly higher operating expenses and a larger net loss compared to the prior year Consolidated Statements of Loss and Other Comprehensive Loss (in thousand EUR) | Item | 3 Months Ended June 30, 2025 (thousand EUR) | 3 Months Ended June 30, 2024 (thousand EUR) | 6 Months Ended June 30, 2025 (thousand EUR) | 6 Months Ended June 30, 2024 (thousand EUR) | | :----------------------------------- | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Revenue | 1,340 | 771 | 2,404 | 1,992 | | Cost of goods sold | (490) | (281) | (896) | (735) | | Gross profit | 850 | 490 | 1,508 | 1,257 | | Research and Development Expense | (10,059) | (7,472) | (19,048) | (14,671) | | Selling, General and Administrative Expense | (10,672) | (6,383) | (23,063) | (12,355) | | Operating loss for the period | (19,850) | (13,307) | (40,488) | (25,520) | | Financial income | 2,858 | 2,069 | 5,480 | 3,477 | | Financial expense | (3,337) | (1,445) | (7,579) | (2,436) | | Loss for the period before taxes | (20,329) | (12,683) | (42,587) | (24,479) | | Income taxes | (278) | (441) | (404) | (551) | | **Loss for the period** | **(20,607)** | **(13,124)** | **(42,991)** | **(25,030)** | | Basic Loss Per Share (in EUR) | (0.551) | (0.428) | (1.149) | (0.843) | | Diluted Loss Per Share (in EUR) | (0.551) | (0.428) | (1.149) | (0.843) | [Interim Consolidated Statements of Changes in Equity](index=10&type=section&id=INTERIM%20CONSOLIDATED%20STATEMENTS%20OF%20CHANGES%20IN%20EQUITY) The company's equity decreased significantly for the six months ended June 30, 2025, primarily due to the net loss for the period, partially offset by equity-settled share-based payments Changes in Equity (in thousand EUR) | Item | January 1, 2025 (thousand EUR) | June 30, 2025 (thousand EUR) | | :------------------------------------ | :----------------------------- | :--------------------------- | | Total equity attributable to shareholders | 113,254 | 73,397 | | Loss for the period | — | (42,991) | | Other comprehensive income for the period | — | 230 | | Equity-settled share-based payments | — | 2,904 | [Interim Consolidated Statements of Cash Flows](index=11&type=section&id=INTERIM%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) For the six months ended June 30, 2025, the company experienced increased cash usage in operating activities, generated net cash from investing activities (primarily from asset sales), and used cash in financing activities Consolidated Statements of Cash Flows (in thousand EUR) | Cash Flow Activity | H1 2025 (thousand EUR) | H1 2024 (thousand EUR) | | :------------------------------------ | :--------------------- | :--------------------- | | Net cash used in operating activities | (35,253) | (23,593) | | Net cash generated/(used) in investing activities | 26,786 | (15,564) | | Net cash generated/(used) from financing activities | (1,202) | 44,981 | | Cash and cash equivalents at June 30 | 22,729 | 27,724 | - Net cash generated in investing activities for H1 2025 was primarily due to **proceeds from the sale of financial assets**[43](index=43&type=chunk) - Net cash used in financing activities for H1 2025 contrasts with H1 2024, which saw significant cash generation from **share issuances**[43](index=43&type=chunk) [Notes to the Unaudited Condensed Interim Consolidated Financial Information](index=12&type=section&id=NOTES%20TO%20THE%20UNAUDITED%20CONDENSED%20INTERIM%20CONSOLIDATED%20FINANCIAL%20INFORMATION) This section provides detailed notes supporting the interim consolidated financial statements, covering accounting policies, estimates, segment reporting, and specific financial line items [General Information](index=12&type=section&id=1.%20General%20information) Nyxoah SA is a Belgian medical technology company developing and commercializing the CE-Marked Genio® system for Obstructive Sleep Apnea, with subsidiaries in Israel, Australia, USA, and Germany - Nyxoah SA is a medical technology company focused on the development and commercialization of innovative solutions to treat **Obstructive Sleep Apnea (OSA)**[46](index=46&type=chunk) - Its lead solution is the **Genio® system**, a CE-Marked, patient-centric, minimally invasive, next-generation hypoglossal neurostimulation therapy for OSA[46](index=46&type=chunk) - The Genio® system is the first neurostimulation system for OSA to include a **battery-free and leadless neurostimulator** capable of delivering bilateral hypoglossal nerve stimulation[47](index=47&type=chunk) - The company has wholly owned subsidiaries in Israel, Australia, the USA, and Germany[49](index=49&type=chunk) [Material Accounting Policies](index=12&type=section&id=2.%20Material%20accounting%20policies) Interim financial statements adhere to IAS 34, consistent with 2024 annual statements, but the company's deficits raise going concern doubts, which management aims to mitigate with future funding - The interim condensed consolidated financial statements are prepared in accordance with **International Accounting Standard 34 – Interim Financial Reporting ('IFRS')**[51](index=51&type=chunk) - The company has consistently operated with deficits and sustained negative cash flows since its inception, resulting in an accumulated loss of **€260.2 million** and total assets of **€116.5 million** as at June 30, 2025[55](index=55&type=chunk) - Existing cash and cash equivalents and marketable securities are projected to fund operations until early 2026, raising **significant doubt about going concern**[57](index=57&type=chunk) - Despite funding challenges, management is confident in raising sufficient funding for at least 12 months following the date these financials are authorized for issuance, given the positive outcome from the DREAM trial and FDA approval for the Genio® system[58](index=58&type=chunk) [Critical Accounting Estimates and Assumptions](index=16&type=section&id=3.%20Critical%20accounting%20estimates%20and%20assumptions) The preparation of interim financial statements requires management to make significant judgments, estimates, and assumptions, which are consistent with those used in the 2024 year-end consolidated financial statements - The preparation of interim financial statements requires management to make judgments, estimates and assumptions that may significantly affect the reported amounts[62](index=62&type=chunk) - The critical accounting estimates used are consistent with those followed in the preparation of the Company's annual consolidated financial statements as of and for the year ended December 31, 2024[63](index=63&type=chunk) [Segment Reporting](index=16&type=section&id=4.%20Segment%20reporting) Based on its organizational structure and the financial information reviewed by its chief operating decision maker (the CEO), the company has concluded that its total operations represent a single reportable segment - The company has concluded that its total operations represent **one reportable segment**[64](index=64&type=chunk) - The chief operating decision maker is the **CEO**[64](index=64&type=chunk) [Fair Value](index=16&type=section&id=5.%20Fair%20Value) Most current assets and liabilities approximate fair value, while derivative financial instruments and synthetic warrants are measured at fair value through profit and loss using specific valuation models - The carrying amount of cash and cash equivalents, trade receivables, other receivables, financial assets and other current assets approximate their value due to their **short-term character**[65](index=65&type=chunk) - Derivative financial liabilities and assets (foreign currency swaps and forwards) are measured at **fair value through profit and loss**, determined by the financial institution[67](index=67&type=chunk) - Synthetic warrants are measured at fair value through profit and loss using a **binomial tree model**, with expected volatility of **66.205%** as a key unobservable input[67](index=67&type=chunk) Fair Value of Financial Assets and Liabilities (in thousand EUR) | Item | Carrying Value (June 30, 2025, thousand EUR) | Fair Value (June 30, 2025, thousand EUR) | Carrying Value (Dec 31, 2024, thousand EUR) | Fair Value (Dec 31, 2024, thousand EUR) | | :-------------------------------------- | :------------------------------------------- | :----------------------------------------- | :------------------------------------------- | :----------------------------------------- | | **Financial Assets** | | | | | | Other long-term receivables (level 3) | 452 | 452 | 395 | 395 | | Prepayment option (level 3) | 170 | 170 | 112 | 112 | | Trade and other receivables (level 3) | 3,974 | 3,974 | 4,293 | 4,293 | | Foreign currency swaps and forwards (level 2) | 493 | 493 | — | — | | Other current assets (level 3) | 292 | 292 | 739 | 739 | | Cash and cash equivalents (level 1) | 22,729 | 22,729 | 34,186 | 34,186 | | Financial assets (level 1) | 20,257 | 20,257 | 51,369 | 51,369 | | **Financial Liabilities** | | | | | | Loan facility agreement (level 3) | 7,093 | 7,915 | 6,898 | 7,151 | | Synthetic warrants (level 3) | 2,696 | 2,696 | 3,204 | 3,204 | | Foreign currency swaps and forwards (level 2) | — | — | 353 | 353 | | Recoverable cash advances (level 3) | 9,385 | 9,385 | 8,871 | 8,871 | | Trade and other liabilities (level 1 and 3) | 10,961 | 10,961 | 11,338 | 11,338 | [Subsidiaries](index=17&type=section&id=6.%20Subsidiaries) The company maintains 100% ownership of its four subsidiaries: Nyxoah LTD in Israel, Nyxoah PTY LTD in Australia, Nyxoah Inc. in the USA, and Nyxoah GmbH in Germany - The Company owns **100%** of the shares of Nyxoah LTD (Israel), Nyxoah PTY LTD (Australia), Nyxoah Inc. (USA), and Nyxoah GmbH (Germany)[71](index=71&type=chunk)[72](index=72&type=chunk) [Property, Plant and Equipment](index=17&type=section&id=7.%20Property%2C%20Plant%20and%20Equipment) Acquisitions of property, plant, and equipment for the first half of 2025 totaled **0.8 million EUR**, primarily for the U.S. production line and laboratory equipment, with depreciation charges increasing to **457,000 EUR** - Total acquisitions for the six months ended June 30, 2025, amounted to **€0.8 million**, mainly related to the U.S. production line under construction and laboratory equipment[73](index=73&type=chunk) - The depreciation charge amounted to **€457,000** for the six months ended June 30, 2025, compared to €336,000 in the prior year period[74](index=74&type=chunk) [Intangible Assets](index=18&type=section&id=8.%20Intangible%20assets) The net book value of intangible assets increased to **51.4 million EUR** as of June 30, 2025, with **1.5 million EUR** in capitalized development expenses for the improved second-generation Genio® system Intangible Assets Net Book Value (in thousand EUR) | Item | June 30, 2025 (thousand EUR) | June 30, 2024 (thousand EUR) | | :---------------- | :--------------------------- | :--------------------------- | | Net book value | 51,407 | 49,310 | - Capitalized development expenses amounted to **€1.5 million** for the six months ended June 30, 2025, related to the improved second-generation Genio® system and clinical trials[76](index=76&type=chunk) - Amortization of intangible assets amounted to **€477,000** for the six months ended June 30, 2025, and is included in research and development expense[75](index=75&type=chunk) [Right-of-Use Assets and Lease Liabilities](index=18&type=section&id=9.%20Right%20of%20use%20assets%20and%20lease%20liabilities) For the first half of 2025, the company entered into new lease agreements totaling **34,000 EUR**, with lease liability repayments of **0.7 million EUR** and depreciation on right-of-use assets of **0.6 million EUR** - New lease agreements for the six months ended June 30, 2025, amounted to **€34,000**[77](index=77&type=chunk) - Repayments of lease liabilities totaled **€0.7 million** for the six months ended June 30, 2025[77](index=77&type=chunk) - Depreciation on right-of-use assets amounted to **€0.6 million** for the six months ended June 30, 2025[77](index=77&type=chunk) [Other Long-Term Receivables](index=18&type=section&id=10.%20Other%20long-term%20receivables) Other long-term receivables totaled **1.8 million EUR** as of June 30, 2025, primarily from an R&D tax incentive, cash guarantees, and a prepayment option, with the Belgian R&D tax credit regime amended to accelerate refunds Other Long-Term Receivables (in thousand EUR) | Item | June 30, 2025 (thousand EUR) | December 31, 2024 (thousand EUR) | | :-------------------------- | :--------------------------- | :--------------------------- | | R&D tax incentive | 1,177 | 1,110 | | Prepayment option | 170 | 112 | | Cash guarantees | 452 | 395 | | **Total other long term receivables** | **1,799** | **1,617** | - The Belgian R&D tax credit regime was amended by the Law of May 12, 2024, changing the refund period from **5 years to 4 years** as of 2024[80](index=80&type=chunk) [Inventory](index=20&type=section&id=11.%20Inventory) Total inventory increased to **5.3 million EUR** as of June 30, 2025, driven by increased activities to prepare for commercialization in the U.S. and further scale-up in the EU Inventory (in thousand EUR) | Item | June 30, 2025 (thousand EUR) | December 31, 2024 (thousand EUR) | | :-------------- | :--------------------------- | :--------------------------- | | Raw materials | 1,290 | 1,080 | | Work in progress | 2,351 | 2,546 | | Finished goods | 1,691 | 1,090 | | **Total Inventory** | **5,332** | **4,716** | - The increase in inventory is due to increasing activities to prepare for **commercialization in the U.S.** and further scale-up of commercialization in the EU in 2025[81](index=81&type=chunk) [Trade Receivables, Contract Assets, and Other Receivables](index=20&type=section&id=12.%20Trade%20receivables%2C%20Contract%20assets%20and%20Other%20receivables) Total trade receivables, contract assets, and other receivables decreased by **304,000 EUR** to **5.8 million EUR** as of June 30, 2025, mainly due to decreases in VAT and trade receivables, with **1.5 million EUR** reclassified to contract assets Trade Receivables, Contract Assets and Other Receivables (in thousand EUR) | Item | June 30, 2025 (thousand EUR) | December 31, 2024 (thousand EUR) | | :------------------------------------------ | :--------------------------- | :--------------------------- | | Trade receivables | 1,330 | 3,382 | | Contract assets | 1,508 | — | | R&D incentive receivable (Australia) | 196 | 155 | | VAT receivable | 401 | 741 | | Current tax receivable | 788 | 967 | | Foreign currency swaps and forwards | 493 | — | | Other | 1,136 | 911 | | **Total trade receivables, contract assets and other receivables** | **5,852** | **6,156** | - The decrease of **€304,000** is mainly due to a decrease in VAT receivable by **€340,000** and a decrease in trade receivables and contract assets by **€0.5 million**, partly offset by an increase in foreign currency swaps and forwards of **€493,000**[82](index=82&type=chunk) - As of June 30, 2025, the Company reclassified **€1.5 million** trade receivables to contract assets because invoices become payable upon the implantation of the Genio® system in the patient, making the right to consideration conditional[84](index=84&type=chunk) [Other Current Assets](index=21&type=section&id=13.%20Other%20current%20assets) Other current assets decreased by **0.7 million EUR** to **942,000 EUR** as of June 30, 2025, primarily due to decreases in accrued income and deferred charges Other Current Assets (in thousand EUR) | Item | June 30, 2025 (thousand EUR) | December 31, 2024 (thousand EUR) | | :--------------- | :--------------------------- | :--------------------------- | | Deferred charges | 650 | 918 | | Accrued income | 292 | 739 | | **Total other current assets** | **942** | **1,657** | - The decrease of **€0.7 million** in other current assets is due to a decrease in accrued income amounting to **€447,000** and a decrease in deferred charges amounting to **€268,000**[86](index=86&type=chunk) [Cash and Cash Equivalents](index=21&type=section&id=14.%20Cash%20and%20cash%20equivalents) Cash and cash equivalents decreased to **22.7 million EUR** as of June 30, 2025, from **34.2 million EUR** at December 31, 2024, mainly due to a **14.9 million EUR** decrease in short-term deposits Cash and Cash Equivalents (in thousand EUR) | Item | June 30, 2025 (thousand EUR) | December 31, 2024 (thousand EUR) | | :------------------ | :--------------------------- | :--------------------------- | | Short term deposit | 13,328 | 28,220 | | Current accounts | 9,401 | 5,966 | | **Total cash and cash equivalents** | **22,729** | **34,186** | - Cash and cash equivalents decreased by **€11.4 million**, mainly due to a **€14.9 million** decrease of short-term deposits, partially offset by a **€3.4 million** increase of current accounts[87](index=87&type=chunk) [Financial Assets](index=21&type=section&id=15.%20Financial%20assets) Current financial assets, primarily term accounts, totaled **20.3 million EUR** as of June 30, 2025, including **14.5 million EUR** in USD-denominated assets, exposing the company to foreign currency exchange risk - Current financial assets relate to term accounts with an initial maturity longer than 3 months but less than 12 months, measured at amortized costs[88](index=88&type=chunk) - As at June 30, 2025, current financial assets totaled **€20.3 million**, consisting of **$17.0 million (€14.5 million)** and **€5.8 million**[89](index=89&type=chunk) - The USD-denominated assets could generate **foreign currency exchange gains or losses** due to USD/EUR exchange rate fluctuations[89](index=89&type=chunk) [Share Capital, Share Premium, and Reserves](index=22&type=section&id=16.%20Share%20Capital%2C%20Share%20Premium%2C%20Reserves) As of June 30, 2025, share capital was **6.4 million EUR** with **37,435,640 shares** and **332.6 million EUR** in share premium, with reserves including share-based payment, other comprehensive income, and retained loss - As at June 30, 2025, the share capital of the Company amounts to **€6.4 million** represented by **37,435,640 shares**, and the share premium amounts to **€332.6 million** before deduction of transaction costs[95](index=95&type=chunk) - In H1 2025, the company issued **2,000 new shares** on May 12 and **6,375 new shares** on June 13, both pursuant to the exercise of warrants[105](index=105&type=chunk) - Reserves include the share-based payment reserve, other comprehensive income (comprised of currency translation differences and remeasurements of post-employment benefit obligations), and retained loss[106](index=106&type=chunk) - Other comprehensive income for the six months ended June 30, 2025, increased by **€230,000** due to currency translation differences[106](index=106&type=chunk) [Share-Based Compensation](index=25&type=section&id=17.%20Share-Based%20compensation) The company has four outstanding equity-settled share-based incentive plans, with **2,797,941 warrants outstanding** and **146,531 Restricted Stock Units (RSUs)** granted in H1 2025, leading to a total share-based payment expense of **2.9 million EUR** Equity-Settled Warrant Plans Summary | Metric | 2025 (units) | 2024 (units) | | :------------------------------------------------------- | :----------- | :----------- | | Outstanding at January 1 | 2,258,319 | 1,635,606 | | Granted | 658,374 | 385,250 | | Forfeited | (37,377) | (13,625) | | Exercised | (13,875) | (24,275) | | Expired | (67,500) | (35,975) | | **Outstanding as at June 30** | **2,797,941**| **1,946,981**| | **Exercisable as at June 30** | **1,715,849**| **1,210,613**| - During H1 2025, **658,374 warrants** were granted from the 2024 and 2025 plans, and **13,875 warrants** were exercised[108](index=108&type=chunk)[109](index=109&type=chunk)[110](index=110&type=chunk) - On June 11, 2025, the Company granted a total of **146,531 Restricted Stock Units (RSUs)** to 7 directors, which will vest at the shareholders' meeting in June 2026[117](index=117&type=chunk) - The Company recognized **€2.9 million** in share-based payment expense for the six months ended June 30, 2025 (compared to €1.5 million in H1 2024)[118](index=118&type=chunk) [Financial Debt](index=30&type=section&id=18.%20Financial%20Debt) Financial debt totaled **19.2 million EUR** as of June 30, 2025, primarily comprising recoverable cash advances (**9.4 million EUR**) and the EIB loan facility agreement (**7.1 million EUR**) with associated synthetic warrants (**2.7 million EUR**) Financial Debt (in thousand EUR) | Item | June 30, 2025 (thousand EUR) | December 31, 2024 (thousand EUR) | | :-------------------------------- | :--------------------------- | :--------------------------- | | Recoverable cash advances - Non-current | 9,139 | 8,623 | | Recoverable cash advances - Current | 246 | 248 | | EIB finance agreement - Non-current | 7,093 | 6,898 | | Synthetic warrants - Non-current | 2,696 | 3,204 | | **Total Financial Debt** | **19,174** | **18,973** | - On July 3, 2024, the Company signed a **€37.5 million** loan facility agreement with the European Investment Bank (EIB), with the first tranche of **€10 million** disbursed on July 26, 2024[127](index=127&type=chunk) - In connection with the EIB loan, the EIB was granted **468,384 synthetic warrants** with a strike price of **€8.54**, exercisable after the maturity of Tranche A (5 years) or earlier in exceptional situations[128](index=128&type=chunk) Sensitivity Analysis of Recoverable Cash Advances (Fair Value as of end of 2025, in thousand EUR) | Variation of discount rates * | -25% (thousand EUR) | 0% (thousand EUR) | 25% (thousand EUR) | | :-------------------------- | :------------------ | :---------------- | :----------------- | | -25% | 9,786 | 10,152 | 10,400 | | 0% | 8,947 | 9,385 | 9,687 | | 25% | 8,213 | 8,705 | 9,049 | * A change of -25% in the discount rates implies that the discount rate used for the fixed part of the recoverable cash advances is 3.8% instead of 5% while the one used for the variable part is 9.4% instead of 12.5%. [Provisions](index=32&type=section&id=19.%20Provisions) Total provisions decreased to **404,000 EUR** as of June 30, 2025, mainly due to a decrease in constructive obligations, while the company faces a patent infringement lawsuit from Inspire Medical, Inc. with legal costs recognized in R&D expenses Provisions (in thousand EUR) | Item | June 30, 2025 (thousand EUR) | December 31, 2024 (thousand EUR) | | :-------------------------- | :--------------------------- | :--------------------------- | | Provision for constructive obligation | 309 | 672 | | Other provisions | 95 | 328 | | **Total provisions** | **404** | **1,000** | - On May 30, 2025, the Company was sued by Inspire Medical, Inc. for alleged infringement of **3 Inspire patents**[131](index=131&type=chunk) - Given the early stage of litigation, the Company is unable to predict the likelihood of success or quantify any risk of loss, and therefore has not accrued for potential litigation losses as of June 30, 2025. Legal costs incurred are recognized in Research and Development Expense[133](index=133&type=chunk) [Trade Payables](index=33&type=section&id=20.%20Trade%20payables) Total trade payables slightly decreased by **97,000 EUR** to **9.4 million EUR** as of June 30, 2025, primarily due to a decrease in invoices to be received, partially offset by an increase in payables Trade Payables (in thousand EUR) | Item | June 30, 2025 (thousand EUR) | December 31, 2024 (thousand EUR) | | :----------------- | :--------------------------- | :--------------------------- | | Payables | 4,437 | 3,749 | | Invoices to be received | 4,971 | 5,756 | | **Total Trade payables** | **9,408** | **9,505** | - The decrease in total trade payables of **€97,000** is due to a decrease in invoices to be received of **€0.8 million**, partly compensated by an increase in trade payables of **€0.7 million**[134](index=134&type=chunk) [Income Taxes and Deferred Taxes](index=33&type=section&id=21.%20Income%20taxes%20and%20deferred%20taxes) Total income tax expense for H1 2025 was **404,000 EUR**, mainly due to increased income tax payable by subsidiaries and an additional accrual for uncertain tax positions, with the current tax liability primarily related to uncertain tax positions Income Tax Income/(Expense) (in thousand EUR) | Period | H1 2025 (thousand EUR) | H1 2024 (thousand EUR) | | :-------------------------- | :--------------------- | :--------------------- | | Current tax income/(expense) | (407) | (547) | | Deferred tax income/(expense) | 3 | (4) | | **Total Income Tax Income/(Expense)** | **(404)** | **(551)** | - The current tax expense mainly relates to an increase of income tax payable by certain subsidiaries (**€286,000**) and an additional accrual of the liability for uncertain tax positions (**€121,000**)[135](index=135&type=chunk) - The current tax liability of **€4.0 million** mainly relates to a liability for uncertain tax positions for an amount of **€3.8 million**[136](index=136&type=chunk) [Other Liabilities](index=33&type=section&id=22.%20Other%20liabilities) Other liabilities decreased by **453,000 EUR** to **5.8 million EUR** as of June 30, 2025, primarily due to decreases in payroll-related liabilities and foreign currency swaps, partially offset by increases in accrued expenses Other Liabilities (in thousand EUR) | Item | June 30, 2025 (thousand EUR) | December 31, 2024 (thousand EUR) | | :---------------------------------- | :--------------------------- | :--------------------------- | | Holiday pay accrual | 774 | 903 | | Salary | 2,583 | 3,354 | | Accrued expenses | 963 | 511 | | Foreign currency swaps and forwards - current | — | 353 | | Other | 1,451 | 1,103 | | **Total other liabilities** | **5,771** | **6,224** | - The decrease of **€453,000** is mainly due to a decrease of **€0.9 million** in payroll related liabilities and a decrease of **€353,000** in the fair value of foreign currency swaps and forwards[137](index=137&type=chunk) - This decrease was partly offset by an increase of **€452,000** in accrued expenses and an increase of **€348,000** in Other liabilities[137](index=137&type=chunk) [Foreign Currency Swaps and Forwards](index=33&type=section&id=23.%20Foreign%20currency%20swaps%20and%20forwards) The company uses foreign currency swaps and forwards to manage currency risk from expected USD, AUD, and NIS expenses, with financial assets from these derivatives totaling **493,000 EUR** as of June 30, 2025 - The Company is exposed to currency risk primarily due to expected future USD, AUD, and NIS expenses and uses foreign currency swaps and forwards to reduce this exposure[139](index=139&type=chunk) Notional Amounts of Foreign Currency Swaps and Forwards (in thousand EUR) | Instrument | June 30, 2025 (thousand EUR) | June 30, 2025 (thousand USD/ILS) | | :-------------------------------- | :--------------------------- | :------------------------------- | | Foreign currency swaps EUR - USD | 3,500 | 4,006 | | Foreign currency forwards EUR - USD | 2,000 | 2,111 | | Foreign currency swaps EUR - ILS | 8,000 | 1,953 | | Foreign currency forwards ILS - EUR | 10,000 | 2,414 | | Foreign currency swaps ILS - EUR | 14,000 | 3,371 | Derivative Financial Instruments (in thousand EUR) | Item | June 30, 2025 (thousand EUR) | | :-------------------------- | :--------------------------- | | Financial assets (Total) | 493 | | Foreign currency swaps | 231 | | Foreign currency forwards | 262 | | Financial liabilities (Total) | — | [Results of Operation](index=35&type=section&id=24.%20Results%20of%20operation) Revenue increased to **2.4 million EUR** for H1 2025, primarily from Germany, England, and UAE, but operating expenses significantly rose, with R&D expenses increasing by **14.7%** and SG&A expenses by **86.7%**, mainly due to U.S. commercialization preparations Revenue and Cost of Goods Sold (Six Months Ended June 30, in thousand EUR) | Metric | 2025 (thousand EUR) | 2024 (thousand EUR) | | :----------------- | :------------------ | :------------------ | | Revenue | 2,404 | 1,992 | | Cost of goods sold | 896 | 735 | - For H1 2025, sales were generated primarily in **Germany (€2.1 million)**, **England (€268,000)**, and **UAE (€32,000)**[146](index=146&type=chunk) Operating Expenses (Six Months Ended June 30, 2025, in thousand EUR) | Expense Type | Total Cost (thousand EUR) | Capitalized (thousand EUR) | Operating Expense for the Period (thousand EUR) | | :----------------------------------- | :------------------------ | :------------------------- | :---------------------------------------------- | | Research and development | 20,602 | (1,554) | 19,048 | | Selling, general and administrative | 23,063 | — | 23,063 | | Other income/(expense) | (171) | 56 | (115) | | **Total** | **43,494** | **(1,498)** | **41,996** | - Selling, general and administrative expenses increased by **€10.7 million** or **86.7%** for H1 2025, mainly due to increased costs to support U.S. commercialization preparations[154](index=154&type=chunk) - Research and development expenses (before capitalization) increased by **€2.6 million** or **14.7%** for H1 2025, due to higher R&D activities and consulting fees, offset by decreased clinical study expenses[151](index=151&type=chunk) [Employee Benefits](index=40&type=section&id=25.%20Employee%20benefits) Total employee benefits significantly increased to **21.6 million EUR** for H1 2025, up from **12.1 million EUR** in H1 2024, primarily driven by higher staff costs in both selling, general and administrative, and research and development functions Total Employee Benefits (Six Months Ended June 30, in thousand EUR) | Item | 2025 (thousand EUR) | 2024 (thousand EUR) | | :---------------- | :------------------ | :------------------ | | Salaries | 16,418 | 8,958 | | Social charges | 1,619 | 1,091 | | Pension charges | 299 | 220 | | Share-based payment | 2,862 | 1,499 | | Other | 352 | 321 | | **Total employee benefits** | **21,550** | **12,089** | Employee Benefits Allocation (Six Months Ended June 30, in thousand EUR) | Expense Category | 2025 (thousand EUR) | 2024 (thousand EUR) | | :------------------------------------ | :------------------ | :------------------ | | Selling, general and administrative expenses | 13,270 | 4,876 | | Research & Development expenses | 8,280 | 7,213 | | **Total employee benefits** | **21,550** | **12,089** | [Financial Income](index=40&type=section&id=26.%20Financial%20income) Financial income increased to **5.5 million EUR** for H1 2025, up from **3.5 million EUR** in H1 2024, mainly due to fair value adjustments on foreign currency swaps and synthetic warrants, and increased interest income, with exchange gains amounting to **3.0 million EUR** Financial Income (Six Months Ended June 30, in thousand EUR) | Item | 2025 (thousand EUR) | 2024 (thousand EUR) | | :------------------------------------------ | :------------------ | :------------------ | | Interests | 1,458 | 970 | | Exchange differences | 2,951 | 2,498 | | Fair value adjustment foreign currency swaps and forwards | 493 | — | | Fair value adjustment synthetic warrants | 508 | — | | Fair value adjustment prepayment option | 58 | — | | Other | 12 | 9 | | **Total financial income** | **5,480** | **3,477** | - The increase in financial income is mainly explained by **fair value adjustments on foreign currency swaps and forwards** and on **synthetic warrants**, in addition to an increase in interest income[159](index=159&type=chunk) - Exchange gains amounted to **€3.0 million** for H1 2025, mainly driven by the monthly revaluation on balance sheet items and realized exchange gains on currency swaps and forwards and USD financial assets[160](index=160&type=chunk) [Financial Expense](index=41&type=section&id=27.%20Financial%20expense) Financial expenses significantly increased to **7.6 million EUR** for H1 2025, from **2.4 million EUR** in H1 2024, primarily driven by a substantial increase in exchange differences (**6.1 million EUR**) due to the Euro's appreciation against the USD Financial Expense (Six Months Ended June 30, in thousand EUR) | Item | 2025 (thousand EUR) | 2024 (thousand EUR) | | :------------------------------------------ | :------------------ | :------------------ | | Fair value adjustment foreign currency swaps and forwards | — | 288 | | Recoverable cash advances, Accretion of interest | 539 | 519 | | Interest and bank charges | 761 | 120 | | Interest on lease liabilities | 71 | 74 | | Exchange differences | 6,141 | 1,435 | | Other | 67 | — | | **Total financial expense** | **7,579** | **2,436** | - The financial expenses increased mainly due to an increase in **exchange differences**, amounting to **€6.1 million** for H1 2025[162](index=162&type=chunk) - The main contributor to the currency loss is the revaluation of the Company's USD cash balance and USD financial assets due to the Euro's appreciation (approximately **12.81%** between January 1 and June 30, 2025) during consolidation[165](index=165&type=chunk) [Loss Per Share (EPS)](index=41&type=section&id=28.%20Loss%20Per%20Share%20(EPS)) The basic and diluted loss per share for H1 2025 was **(1.149) EUR**, an increase from **(0.843) EUR** in H1 2024, with no dilutive effect from outstanding warrants due to net losses Loss Per Share (Six Months Ended June 30) | Metric | 2025 (EUR) | 2024 (EUR) | | :------------------------------------ | :--------- | :--------- | | Loss of year attributable to equity holders | (42,991,000) | (25,030,000) | | Weighted average number of common shares outstanding (units) | 37,429,260 | 29,706,019 | | Basic earnings per share | (1.149) | (0.843) | | Diluted earnings per share | (1.149) | (0.843) | - As the Company is incurring net losses, outstanding warrants have **no dilutive effect**, resulting in no difference between the Basic and Diluted EPS[168](index=168&type=chunk) [Other Commitments](index=43&type=section&id=29.%20Other%20commitments) As of June 30, 2025, the company committed to a progress payment of **1.15 million USD** to a key supplier for manufacturing services and inventory purchases, with the payment made in July 2025 - On June 27, 2025, the Company entered into an agreement with a key supplier to make a progress payment of **USD 1,150,000** related to manufacturing services and inventory purchases, with the payment made in July 2025[173](index=173&type=chunk) [Related Party Transactions](index=43&type=section&id=30.%20Related%20Party%20Transactions) This section details remuneration for key management (**2.0 million EUR** for H1 2025) and transactions with non-executive directors and significant shareholders, including a collaboration agreement with Cochlear Limited for a U.S. production line Remuneration of Key Management (Six Months Ended June 30, in thousand EUR) | Item | 2025 (thousand EUR) | 2024 (thousand EUR) | | :------------------------------------ | :------------------ | :------------------ | | Short-term remuneration & compensation | 1,425 | 951 | | Post-employment benefits | 35 | 11 | | Share based payment | 554 | 329 | | **Total** | **2,014** | **1,291** | Transactions with Non-Executive Directors (Six Months Ended June 30, in thousand EUR) | Item | 2025 (thousand EUR) | 2024 (thousand EUR) | | :------------------------------------ | :------------------ | :------------------ | | Set up of Production Line (Cochlear) | 52 | 176 | | Board Remuneration (Total) | 252 | 290 | | Warrant expense (IFRS 2) | 800 | 218 | - The Company and Cochlear Limited entered into a collaboration agreement in January 2023 related to the transfer of assets and support for setting up a production line in the U.S., with a financial impact of **€52,000** for H1 2025[182](index=182&type=chunk) - The Company announced a partnership with ResMed in Germany on September 28, 2023, to increase OSA awareness and therapy penetration[183](index=183&type=chunk) [Events After the Balance-Sheet Date](index=45&type=section&id=31.%20Events%20after%20the%20Balance-Sheet%20Date) In July 2025, the company reorganized its global R&D function, and on August 8, 2025, received **FDA marketing approval** for its Genio® system, enabling U.S. commercial launch and expected positive revenue impact in H2 2025 - In July 2025, the Company reorganized its global R&D function, transitioning all ongoing R&D activities from Israel to the U.S. and Belgium, with no impairment identified[189](index=189&type=chunk) - On August 8, 2025, the Company received **FDA marketing approval** for its Genio® system, enabling the commercial launch in the United States[190](index=190&type=chunk) - This FDA approval is expected to have a **positive impact on the Company's revenue** beginning in the second half of 2025[190](index=190&type=chunk) [Responsibility Statement](index=46&type=section&id=RESPONSIBILITY%20STATEMENT) The board of directors certifies that the interim financial statements and management report provide a true and fair view of the company's financial position, results, development, and principal risks [Responsibility Statement](index=46&type=section&id=RESPONSIBILITY%20STATEMENT) The board of directors certifies that the interim financial statements and management report provide a true and fair view of the company's financial position, results, development, and principal risks - The condensed consolidated interim financial statements, prepared in accordance with applicable standards, give a **true and fair view** of the assets, liabilities, financial position, and results of the Company and its consolidated undertakings[194](index=194&type=chunk) - The interim management report provides a **true and fair overview** of the development, results, and position of the Company and its consolidated undertakings, as well as a description of the principal risks and uncertainties they face[194](index=194&type=chunk)

Core Insights - Nyxoah has received FDA approval for its Genio system, marking a significant milestone as it becomes the first and only bilateral hypoglossal neurostimulation therapy approved in the U.S. for Obstructive Sleep Apnea (OSA) [4][5][8] - The company has initiated the commercial launch of the Genio system in the U.S., supported by positive data from the DREAM pivotal trial, which demonstrated significant efficacy in reducing apnea-hypopnea index (AHI) [4][6][8] Financial Performance - Revenue for Q2 2025 was €1.34 million, a 74% increase from €0.77 million in Q2 2024 [8][12] - Gross profit for Q2 2025 was €0.85 million, with a gross margin of 63.4%, compared to a gross profit of €0.49 million and a margin of 63.6% in Q2 2024 [7][13] - Operating loss for Q2 2025 was €19.85 million, up from €13.33 million in Q2 2024, primarily due to increased selling, general, and administrative expenses related to the commercialization of the Genio system [7][16][17] Research and Development - R&D expenses for Q2 2025 were €10.06 million, compared to €7.47 million in Q2 2024, reflecting increased R&D activities [14] - Selling, general, and administrative expenses rose to €10.67 million in Q2 2025 from €6.38 million in Q2 2024, driven by costs associated with the commercialization efforts for the Genio system [15] Cash Position - As of June 30, 2025, the company had cash, cash equivalents, and financial assets totaling €43.0 million, down from €63.0 million at the end of Q1 2025 [8][18] Market Position - The Genio system is positioned as a differentiated solution for OSA patients, particularly those underserved by existing therapies, with a focus on providing a leadless and battery-free treatment option [4][22]

Company Overview - Nyxoah (NYXH) received FDA approval for its Genio system, an innovative therapy for moderate to severe Obstructive Sleep Apnea (OSA) featuring a leadless, battery-free design powered by an upgradable wearable [1][8] - The Genio system utilizes a unique bilateral nerve stimulation approach, now launching in the U.S. market [1][3] Clinical Trial Results - The FDA approval was supported by the DREAM pivotal trial, which achieved a 63.5% apnea-hypopnea index (AHI) responder rate and a 71.3% Oxygen Desaturation Index (ODI) responder rate, with a median AHI reduction of 70.8% [4] - Notably, 82% of participants saw their AHI drop below 15, demonstrating Genio's efficacy across all sleeping positions [4][5] Product Features - Genio's design is MRI compatible (1.5T and 3T), making it more convenient and less invasive for patients [3] - The system is powered and controlled by a wearable component, which is fully upgradable, allowing for technology updates without additional surgeries or battery replacements [3][5] Market Prospects - The global sleep apnea devices market was estimated at $4.5 billion in 2023 and is projected to reach $6.9 billion by 2030, with a CAGR of 6.2% from 2024 to 2030 [6] - Key growth drivers include a growing geriatric population, a significant patient pool with sleep apnea, and the development of advanced devices [6] Competitive Landscape - Nyxoah competes with several innovative players in the sleep apnea treatment market, including Inspire Medical Systems, ResMed, and LivaNova, all of which are developing advanced therapies and devices [7][10][11] - Inspire Medical Systems launched its Inspire V neurostimulation system, which features a 20% reduction in implant time and Bluetooth-enabled connectivity [7][9] - ResMed introduced its AirSense 11 CPAP device with advanced capabilities to enhance patient adherence and clinician access [10] - LivaNova reported a 65% responder rate in its OSPREY trial for its aura6000 proximal hypoglossal nerve stimulator, indicating sustained efficacy [11]

Core Viewpoint - Nyxoah has reported preliminary financial results for Q2 2025, indicating significant growth and successful commercial proof of concept in Germany, with plans to expand into the U.S. market following FDA approval of its Genio system [1][3]. Financial Results - Revenue for Q2 2025 is anticipated to be approximately €1.3 million, representing a 73% increase compared to Q2 2024 [4]. - Operating expenses for Q2 2025 are expected to be around €20.7 million, a 50% increase from Q2 2024 [4]. - Cash, cash equivalents, and financial assets are projected to be approximately €43.0 million as of June 30, 2025 [4]. Business Updates - The Genio system has received FDA approval for a subset of adult patients with moderate to severe Obstructive Sleep Apnea (OSA), specifically those with an Apnea-Hypopnea Index (AHI) between 15 and 65 [4][6]. - The company plans to close patient enrollment in its ACCCESS clinical trial, which aims to assess the safety and efficacy of Genio therapy for patients suffering from Complete Concentric Collapse (CCC) [4]. - Nyxoah has reorganized its global R&D function, transitioning ongoing activities from Israel to the U.S. and Belgium [4]. Legal Matters - Inspire Medical Systems, Inc. has filed a lawsuit against Nyxoah in the U.S. for alleged patent infringement, and the company intends to vigorously defend itself [4].

Core Viewpoint - Nyxoah has received FDA approval for its Genio system, a novel treatment for obstructive sleep apnea (OSA), marking a significant advancement in the U.S. market for OSA therapies [2][4]. Company Overview - Nyxoah is a medical technology company focused on innovative solutions for OSA, with its lead product being the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy [7]. - The company aims to enhance the quality of life for OSA patients by providing effective treatment options [7]. Product Details - The Genio system utilizes bilateral stimulation and is designed to be MRI compatible, offering a non-implanted battery solution controlled by a wearable component [3]. - The wearable component is fully upgradable, allowing patients to access technological advancements without additional surgeries [3]. Clinical Data - The FDA approval was based on the DREAM pivotal trial, which demonstrated a 63.5% AHI responder rate and a 71.3% Oxygen Desaturation Index responder rate, with a median AHI reduction of 70.8% [4]. - Notably, 82.0% of subjects in the DREAM study achieved AHI scores below 15 [4]. - The study also showed efficacy across different sleeping positions, with a median AHI reduction of 66.6% in the supine position, which is significant given the increased airway obstruction risk in that position [5][6]. Market Impact - The approval of the Genio system expands treatment options for physicians managing OSA, particularly due to its consistent efficacy across various sleeping positions [6]. - The company is poised to execute its U.S. commercialization strategy following this approval [4].