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ניקסואה מדווחת על תוצאותיה הכספיות והתפעוליות של הרבעון הראשון של 2026

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Nyxoah SA (נאסד"ק/יורונקסט בריסל: NYXH), חברת טכנולוגיות רפואיות המפתחת חלופות טיפול פורצות דרך לדום נשימה חסימתי בשינה (OSA), דיווחה היום על תוצאות כספיות ותפעוליות לרבעון הראשון של 2026.

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<html> <head> <title>ניקסואה מדווחת על תוצאותיה הכספיות והתפעוליות של הרבעון הראשון של 2026</title> <meta name="description" content="Nyxoah SA (נאסד"ק/יורונקסט בריסל: NYXH), חברת טכנולוגיות רפואיות המפתחת חלופות טיפול פורצות דרך לדום נשימה חסימתי בשינה (OSA), דיווחה היום על תוצאות כספיות ותפעוליות לרבעון הראשון של 2026."> <meta name="keywords" content="GLOBE NEWSWIRE, noy tikshoret"> <meta name="expires" CONTENT="never"> <meta name="language" CONTENT="hebrew"> <meta name="distribution" CONTENT="Global"> <meta name="robots" content="index, follow"> <meta http-equiv="Content-Type" content="text/html; charset=windows-1255"> </title> <body dir="rtl"> <h1>ניקסואה מדווחת על תוצאותיה הכספיות והתפעוליות של הרבעון הראשון של 2026</h1><br/> <br/><strong>נכתב על ידי: <a title="ניקסואה מדווחת על תוצאותיה הכספיות והתפעוליות של הרבעון הראשון של 2026" href="http://www.portal-asakim.com/Authors//Author576.aspx ">חיים נוי</a></strong><br/> <br/><p> <p>מידע מוסדר</p> <p align="center">ניקסואה מדווחת על תוצאותיה הכספיות והתפעוליות של הרבעון הראשון של 2026</p> <p>מונט-סן-גיבר, בלגיה – 12 במאי 2026, GLOBE NEWSWIRE – </p> <p>Nyxoah SA (נאסד"ק/יורונקסט בריסל: NYXH), חברת טכנולוגיות רפואיות המפתחת חלופות טיפול פורצות דרך לדום נשימה חסימתי בשינה (OSA), דיווחה היום על תוצאות כספיות ותפעוליות לרבעון הראשון של 2026.</p> <p align="right"> </p> <p align="right">REGULATED INFORMATION</p> <p align="center">Nyxoah Reports First Quarter 2026 Financial and Operating Results</p> <p align="center"><em>Strong Genio launch in the U.S. drove 25% sequential quarterly U.S. revenue growth</em><br /> <em>Continued clarity around HGNS and Genio reimbursement in the U.S.</em></p> <p>Mont-Saint-Guibert, Belgium – May 12, 2026,GLOBE NEWSWIRE –</p> <p>Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today reported financial and operating results for the first quarter of 2026.</p> <p>Q1 2026 Financial and Operating Highlights</p> <ul type="disc"> <li>Financials <ul type="circle"> <li>U.S. net revenue first quarter 2026 was €4.3 million (gross revenuewas €4.5 million), 25% sequential growth over net revenue fourth quarter2025</li> <li>Global net revenue first quarter 2026 was €6.4 million (gross revenuewas €6.7 million), 13% sequential growth over net revenue fourth quarter2025</li> </ul> </li> <li>LeadingU.S. commercial indicators <ul type="circle"> <li>62 new surgeons trained in Q1, bringing the total to 207 surgeonstrained</li> <li>34 new accounts activated in Q1, bringing the total to 91 activehigh-volume accounts</li> <li>241 patients submitted under prior authorization and still pending atthe end of Q1</li> </ul> </li> <li>U.S.reimbursement landscape – further clarified <ul type="circle"> <li>Medicare issued new C-Codes covering Genio and clarified facility andphysician payments</li> <li>Commercial payers continued reimbursement under existing CPT codes</li> <li>100% prior-authorization approval obtained on reviewed submissionswith commercial payers and WISeR program</li> </ul> </li> <li>Asof March 31, 2026, cash, cash equivalents and financial assets amounted to€25.9 million. In the second quarter of 2026, the Company expects to draw€13.8 million from the second tranche of the European Investment Bankloan.</li> </ul> <p>“Our first quarter revenue results reflect strong execution of our U.S. launch. The 25% sequential quarterly revenue growth was driven by continued strong activity in existing sites, and high growth in new site openings. We continue to see a consistent reimbursement landscape and had a 100% approval rate on closed U.S. prior authorization submissions as of the end of Q1 2026. Reimbursement did not hinder our first quarter results,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “Entering our third full quarter of U.S. commercialization, we remain focused on further expanding account activation, treating more patients in active accounts and maintaining operating discipline to deliver sustainable revenue growth in the U.S.”</p> <p>Results for the Three Months Ended March 31, 2026</p> <p>Revenue</p> <p>Gross revenue for the first quarter of 2026 was €6.7 million before €0.3 million of deferred revenue mainly related to disposable patches which are delivered over time. Net revenue was €6.4 million, compared to €1.1 million in the first quarter of 2025. The increase in net revenue was primarily driven by the continued expansion of U.S. commercialization activities following FDA approval in August 2025, as well as growth in international markets.</p> <p>Cost of Goods Sold</p> <p>Cost of goods sold was €2.7 million for the first quarter of 2026, resulting in a gross profit of €3.6 million and a gross margin of 57%, compared to cost of goods sold of €0.4 million and a gross margin of 62% in the first quarter of 2025. The increase in cost of goods sold was driven by higher volumes associated with the U.S. commercialization. The decrease in gross margin reflects production yield issues which have been addressed.</p> <p>Research and Development</p> <p>For the first quarter of 2026, research and development expenses were €8.8 million, versus €9.0 million for the first quarter of 2025. The decrease in research and development expenses reflects reduced investments in clinical study costs such as DREAM and ACCCESS.</p> <p>Selling, General and Administrative</p> <p>For the first quarter of 2026, selling, general and administrative expenses were €15.4 million, versus €12.4 million for the first quarter of 2025. The increase in selling, general and administrative expenses was primarily driven by the continued build-out of the Company’s U.S. commercial organization, including sales, marketing, and market access functions.</p> <p>Operating Loss</p> <p>Total operating loss for the first quarter of 2026 was €20.5 million, versus €20.6 million in the first quarter of 2025. The change in operating loss reflects increased net revenue offset by increased commercial investments to support U.S. launch activities, as well as continued investment in research and development.</p> <p>Cash Position</p> <p>Cash, cash equivalents and financial assets amounted to approximately €25.9 million at March 31, 2026.</p> <p><br /> In the second quarter of 2026, the Company expects to draw €13.8 million from the second tranche of the European Investment Bank loan.</p> <p>Financial Guidance for the Second Quarter of 2026 and Full Year 2026</p> <ul type="disc"> <li>TheCompany expects U.S. net revenue for the second quarter of 2026 to growsequentially by approximately 25-30% over the first quarter of 2026.</li> <li>TheCompany expects worldwide net revenue for the full year 2026 to be in therange of €36 million to €40 million.</li> <li>TheCompany expects the gross margin for the full year 2026 to be in the rangeof 60% to 62%.</li> <li>TheCompany expects total operating expenses for the full year 2026 to be inthe range of €97 million to €99 million. The Company expects non-GAAP cashoperating expenses for the full year 2026 to be in the range of €88million to €90 million. Non-GAAP cash operating expenses reflect expectedtotal operating expenses less non-cash expenses such as depreciation,amortization, and share-based compensation.</li> </ul> <p>Conference call and webcast presentation</p> <p>Company management will host a conference call to discuss financial results on Tuesday, May 12, 2026, beginning at 10:30pm CET / 4:30pm ET.</p> <p>A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: <a href="https://www.globenewswire.com/Tracker?data=iEuL77EsQ-m4SxqZVN5EO6NL-DDW18DQIDBAOnULzPPN0HxsgfWaFY8WiMmIS3GofBKLn9ONO4qp-hFg67k8KzCpAa5FqCnfYFKByhnCVcAQK5Ef7T4dNZYs6rLZkAUCZss0ZaQ95P0sHHQPhFxorg==" target="_blank">Nyxoah's Q1 2026 Earnings Call Webcast</a>. For those not planning to ask a question of management, the Company recommends listening via the webcast.</p> <p>If you plan to ask a question, please use the following link: <a href="https://www.globenewswire.com/Tracker?data=iEuL77EsQ-m4SxqZVN5EO6NL-DDW18DQIDBAOnULzPPwBZEGJoN0BEwMI_hKolbgknGZHQVOKMG-myORY6ZbvRAaoOeX3XJozRBa4ejQS3FZvgGqOGKvFfVY880Lvby-Hl5-_ZDKoMPd9myXCAiZbpuJ77D6swC1Hf-wTQbIQS75tuJ_5-OM16lmsjpj0pYdGRE47PkBXEhmjikqA9OWug==" target="_blank">Nyxoah's Q1 2026 Earnings Call Q&A Link</a>. After registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call.</p> <p>The archived webcast will be available for replay shortly after the close of the call.</p> <p>Non-GAAP financial measures</p> <p>This press release includes non-GAAP (Generally Accepted Accounting Principles) financial measures, including non-GAAP cash operating expenses. Non-GAAP cash operating expenses are calculated by excluding from GAAP certain operating expenses items, including depreciation, amortization, capitalized research and development expenses, impairment losses on intangible assets, and share-based compensation. These non-GAAP financial measures are presented because the Company believes they are useful indicators of its operating performance. Management uses these non-GAAP financial measures as measures of the Company's operating performance and for planning purposes, including the preparation of the Company's annual operating budget and financial projections. The Company believes these measures are useful to investors as supplemental information because they are frequently used by analysts, investors and other interested parties to evaluate companies in its industry. These non-GAAP financial measures should not be considered alternatives to, or superior to, any other performance measure derived in accordance with GAAP. They should not be construed to imply that the Company's future results will be unaffected by unusual or non-recurring items. The Company's definitions of non-GAAP cash operating expenses are not necessarily comparable to other similarly titled captions of other companies due to different methods of calculation.</p> <p>About Nyxoah</p> <p>Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. </p> <p>Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and receipt of approval from the FDA for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65. </p> <p>For more information, please visit <a href="https://www.globenewswire.com/Tracker?data=AtF4Vl5IZ4g_liWzHn0Tk22-5bFKMxp5uoULfROfdvzjVQF8633nKIs0ju9PxSKdIrgmEp3sEg4y2P1F3LsJVUvWFuyjhFWAjcaG5-0A1Hdi3HF_RKUJ1X9bu03kv96SFH48VNoIx3zisRl9Q4txxjdAocQc_e0w1ps8K_9CAyZFWT4osABNoCDEmxQonKoG6uGL5cxcGsxjpRVvN7FQ7fXjJE20jOgBxsutB-ul-DmXERjV_K5MRH00RoEp1H2lmbnYz2uxLhl8p0t4_xSxoQ==" target="_blank">http://www.nyxoah.com/.</a> </p> <p>Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device. Contacts:</p> <p>Nyxoah<br /> John Landry, CFO<br /> <a href="https://www.globenewswire.com/Tracker?data=01nlrDKcLD6z4GheOLXqMyXtWYyTy1Tw0SXlYphBO7Jc8SichC78X7u4OFHntiWvdAWZik4oaT-HcGLm_mzM2g==" target="_blank">IR@nyxoah.com</a></p> <p>Rémi Renard<br /> Head of Investor Relations & Corporate Communication<br /> IR@nyxoah.com</p> <p>Attachment</p> <ul type="disc"> <li>ENGLISH_Earnings PR 1Q26</li> </ul> <p>*** הידיעה מופצת בעולם על ידי חברת התקשורת הבינלאומית GlobeNewswire</p> </p> <br/><br/> <strong><u>פרטים אודות כותב המאמר</u></strong> <br/> <p><strong>חיים נוי, עיתונאי, עורך ראשי של סוכנות החדשות הבינ"ל IPA, לשעבר עורך ראשי של סוכנות הידיעות עתים, חבר תא מבקרי התיאטרון באגודת העיתונאים</strong></p> <br/><a href="http://www.portal-asakim.com"> מקור המאמר: אתר מאמרים עסקיים ומקצועיים</a>

גירסת טקסט:
ניקסואה מדווחת על תוצאותיה הכספיות והתפעוליות של הרבעון הראשון של 2026 מידע מוסדר ניקסואה מדווחת על תוצאותיה הכספיות והתפעוליות של הרבעון הראשון של 2026 מונט-סן-גיבר, בלגיה – 12 במאי 2026, GLOBE NEWSWIRE – Nyxoah SA (נאסד"ק/יורונקסט בריסל: NYXH), חברת טכנולוגיות רפואיות המפתחת חלופות טיפול פורצות דרך לדום נשימה חסימתי בשינה (OSA), דיווחה היום על תוצאות כספיות ותפעוליות לרבעון הראשון של 2026. REGULATED INFORMATION Nyxoah Reports First Quarter 2026 Financial and Operating Results Strong Genio launch in the U.S. drove 25% sequential quarterly U.S. revenue growth Continued clarity around HGNS and Genio reimbursement in the U.S. Mont-Saint-Guibert, Belgium – May 12, 2026,GLOBE NEWSWIRE – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today reported financial and operating results for the first quarter of 2026. Q1 2026 Financial and Operating Highlights Financials U.S. net revenue first quarter 2026 was €4.3 million (gross revenuewas €4.5 million), 25% sequential growth over net revenue fourth quarter2025 Global net revenue first quarter 2026 was €6.4 million (gross revenuewas €6.7 million), 13% sequential growth over net revenue fourth quarter2025 LeadingU.S. commercial indicators 62 new surgeons trained in Q1, bringing the total to 207 surgeonstrained 34 new accounts activated in Q1, bringing the total to 91 activehigh-volume accounts 241 patients submitted under prior authorization and still pending atthe end of Q1 U.S.reimbursement landscape – further clarified Medicare issued new C-Codes covering Genio and clarified facility andphysician payments Commercial payers continued reimbursement under existing CPT codes 100% prior-authorization approval obtained on reviewed submissionswith commercial payers and WISeR program Asof March 31, 2026, cash, cash equivalents and financial assets amounted to€25.9 million. In the second quarter of 2026, the Company expects to draw€13.8 million from the second tranche of the European Investment Bankloan. “Our first quarter revenue results reflect strong execution of our U.S. launch. The 25% sequential quarterly revenue growth was driven by continued strong activity in existing sites, and high growth in new site openings. We continue to see a consistent reimbursement landscape and had a 100% approval rate on closed U.S. prior authorization submissions as of the end of Q1 2026. Reimbursement did not hinder our first quarter results,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “Entering our third full quarter of U.S. commercialization, we remain focused on further expanding account activation, treating more patients in active accounts and maintaining operating discipline to deliver sustainable revenue growth in the U.S.” Results for the Three Months Ended March 31, 2026 Revenue Gross revenue for the first quarter of 2026 was €6.7 million before €0.3 million of deferred revenue mainly related to disposable patches which are delivered over time. Net revenue was €6.4 million, compared to €1.1 million in the first quarter of 2025. The increase in net revenue was primarily driven by the continued expansion of U.S. commercialization activities following FDA approval in August 2025, as well as growth in international markets. Cost of Goods Sold Cost of goods sold was €2.7 million for the first quarter of 2026, resulting in a gross profit of €3.6 million and a gross margin of 57%, compared to cost of goods sold of €0.4 million and a gross margin of 62% in the first quarter of 2025. The increase in cost of goods sold was driven by higher volumes associated with the U.S. commercialization. The decrease in gross margin reflects production yield issues which have been addressed. Research and Development For the first quarter of 2026, research and development expenses were €8.8 million, versus €9.0 million for the first quarter of 2025. The decrease in research and development expenses reflects reduced investments in clinical study costs such as DREAM and ACCCESS. Selling, General and Administrative For the first quarter of 2026, selling, general and administrative expenses were €15.4 million, versus €12.4 million for the first quarter of 2025. The increase in selling, general and administrative expenses was primarily driven by the continued build-out of the Company’s U.S. commercial organization, including sales, marketing, and market access functions. Operating Loss Total operating loss for the first quarter of 2026 was €20.5 million, versus €20.6 million in the first quarter of 2025. The change in operating loss reflects increased net revenue offset by increased commercial investments to support U.S. launch activities, as well as continued investment in research and development. Cash Position Cash, cash equivalents and financial assets amounted to approximately €25.9 million at March 31, 2026. In the second quarter of 2026, the Company expects to draw €13.8 million from the second tranche of the European Investment Bank loan. Financial Guidance for the Second Quarter of 2026 and Full Year 2026 TheCompany expects U.S. net revenue for the second quarter of 2026 to growsequentially by approximately 25-30% over the first quarter of 2026. TheCompany expects worldwide net revenue for the full year 2026 to be in therange of €36 million to €40 million. TheCompany expects the gross margin for the full year 2026 to be in the rangeof 60% to 62%. TheCompany expects total operating expenses for the full year 2026 to be inthe range of €97 million to €99 million. The Company expects non-GAAP cashoperating expenses for the full year 2026 to be in the range of €88million to €90 million. Non-GAAP cash operating expenses reflect expectedtotal operating expenses less non-cash expenses such as depreciation,amortization, and share-based compensation. Conference call and webcast presentation Company management will host a conference call to discuss financial results on Tuesday, May 12, 2026, beginning at 10:30pm CET / 4:30pm ET. A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q1 2026 Earnings Call Webcast. For those not planning to ask a question of management, the Company recommends listening via the webcast. If you plan to ask a question, please use the following link: Nyxoah's Q1 2026 Earnings Call Q&A Link. After registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call. The archived webcast will be available for replay shortly after the close of the call. Non-GAAP financial measures This press release includes non-GAAP (Generally Accepted Accounting Principles) financial measures, including non-GAAP cash operating expenses. Non-GAAP cash operating expenses are calculated by excluding from GAAP certain operating expenses items, including depreciation, amortization, capitalized research and development expenses, impairment losses on intangible assets, and share-based compensation. These non-GAAP financial measures are presented because the Company believes they are useful indicators of its operating performance. Management uses these non-GAAP financial measures as measures of the Company's operating performance and for planning purposes, including the preparation of the Company's annual operating budget and financial projections. The Company believes these measures are useful to investors as supplemental information because they are frequently used by analysts, investors and other interested parties to evaluate companies in its industry. These non-GAAP financial measures should not be considered alternatives to, or superior to, any other performance measure derived in accordance with GAAP. They should not be construed to imply that the Company's future results will be unaffected by unusual or non-recurring items. The Company's definitions of non-GAAP cash operating expenses are not necessarily comparable to other similarly titled captions of other companies due to different methods of calculation. About Nyxoah Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and receipt of approval from the FDA for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65. For more information, please visit http://www.nyxoah.com/. Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device. Contacts: Nyxoah John Landry, CFO IR@nyxoah.com Rémi Renard Head of Investor Relations & Corporate Communication IR@nyxoah.com Attachment ENGLISH_Earnings PR 1Q26 *** הידיעה מופצת בעולם על ידי חברת התקשורת הבינלאומית GlobeNewswire נכתב על ידי חיים נוי, עיתונאי, עורך ראשי של סוכנות החדשות הבינ"ל IPA, לשעבר עורך ראשי של סוכנות הידיעות עתים, חבר תא מבקרי התיאטרון באגודת העיתונאים מקור המאמר:אתר מאמרים עסקיים ומקצועיים http://www.portal-asakim.com
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