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Nyxoah מדווחת על תוצאותיה הכספיות והתפעוליות לרבעון השלישי של 2024
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Nyxoah SA (נאסד"ק/יורונקסט בריסל: NYXH) חברת טכנולוגיות רפואיות המפתחת חלופות טיפול פורצות דרך לדום נשימה בשינה (OSA) באמצעות נוירומודולציה, דיווחה היום על תוצאותיה הכספיות והתפעוליות לרבעון השלישי של 2024.
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<html> <head> <title>Nyxoah מדווחת על תוצאותיה הכספיות והתפעוליות לרבעון השלישי של 2024</title> <meta name="description" content="Nyxoah SA (נאסד"ק/יורונקסט בריסל: NYXH) חברת טכנולוגיות רפואיות המפתחת חלופות טיפול פורצות דרך לדום נשימה בשינה (OSA) באמצעות נוירומודולציה, דיווחה היום על תוצאותיה הכספיות והתפעוליות לרבעון השלישי של 2024."> <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>Nyxoah מדווחת על תוצאותיה הכספיות והתפעוליות לרבעון השלישי של 2024</h1><br/> <br/><strong>נכתב על ידי: <a title="Nyxoah מדווחת על תוצאותיה הכספיות והתפעוליות לרבעון השלישי של 2024" href="http://www.portal-asakim.com/Authors//Author576.aspx ">חיים נוי</a></strong><br/> <br/> <p align="center"><a name="_Hlk168040555">Nyxoah מדווחת על תוצאותיה הכספיות והתפעוליות לרבעון השלישי של 2024</a></p> <p align="center"><em>אישור FDA בדרך עד לרבעון הראשון של 2025, הצוות המסחרי בארה"ב נבנה בהתקדמות</em><em></em></p> <p align="center"><em>החברה ממומנת במלואה במזומנים עד אמצע 2026</em></p> <p>מונט-סנט-גיברט, בלגיה, 6 בנובמבר 2024, (GLOBE NEWSWIRE) :</p> <p>Nyxoah SA (נאסד"ק/יורונקסט בריסל: NYXH) , חברת טכנולוגיות רפואיות המפתחת חלופות טיפול פורצות דרך לדום נשימה בשינה (OSA) באמצעות נוירומודולציה, דיווחה היום על תוצאותיה הכספיות והתפעוליות לרבעון השלישי של 2024.</p> <p>דגשים פיננסיים ותפעוליים אחרונים</p> <p>*הציגה תוצאות משכנעות של נתוני DREAM באגודה הבינלאומית לשינה כירורגית בספטמבר.</p> <p>*גייסה 24.6 מיליון אירו באמצעות תוכנית ATM מקרן ייעודית אחת לשירותי בריאות בארה"ב, מצטברת מצטרפת המאפשרת התאמות בשלבים לקראת המעבר למסחור בארה"ב והארכת יתרת המזומנים עד אמצע 2026.</p> <p>*חיזוק הארגון בארה"ב עם העסקתו של ג'ון לנדרי כמנהל כספים והצטרפותם של מספר מנהלים מסחריים מובילים בארה"ב.</p> <p>*דיווחה על מכירות של 1.3 מיליון אירו ברבעון השלישי, המייצגים צמיחה של 30% לעומת הרבעון השלישי של 2023.</p> <p>*יתרת מזומנים כוללת של 71.0 מיליון אירו בסוף הרבעון, 95.6 מיליון אירו פרופורמה כולל 24.6 מיליון אירו שגויסו.</p> <p>REGULATED INFORMATION</p> <p align="center">Nyxoah Reports Third Quarter Financial and Operating Results</p> <p align="center"><em>FDA approval on track</em> <em>for first quarter 2025, U.S. commercial team build out in progresss</em></p> <p align="center"><em>Company</em> <em>fully funded with cash until mid 2026</em><em></em></p> <p>Mont-Saint-Guibert, Belgium – November 6, 2024, (GLOBE NEWSWIRE)– </p> <p>Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the "Company"), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the third quarter of 2024.</p> <p>Recent Financial and Operating Highlights</p> <ul type="disc"> <li>Presented compelling DREAMdata results at International Surgical Sleep Society in September.</li> <li>Raised €24.6 million through an ATMprogram from a single U.S. healthcare-dedicated fund providingincremental flexibility as we shift into U.S. commercialization andextending cash runway until mid 2026.</li> <li>Strengthened U.S. organizationwith the hiring of John Landry as Chief FinancialOfficer and the addition of severalkey commercial leaders in the U.S.</li> <li>Reported third quarter salesof €1.3 million, representing 30% growth versus thirdquarter 2023.</li> <li>Total cashposition of €71.0 million at the end of thequarter, €95.6 million proforma including the€24.6 million raised.</li> </ul> <p>"Our actions in the third quarter have further positioned us well for a successful U.S. commercial launch. On the back of the robust DREAM data presented in September, we have raised additional capital and are actively focused on building up our U.S. commercial team," commented Olivier Taelman, Nyxoah’s Chief Executive Officer. "I am more confident than ever that we have set Genio up for a strong commercial start in the U.S. immediately after FDA approval."</p> <p><br /> Third Quarter 2024 Results</p> <p>CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)<br /> (in thousands)</p><table border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td width="439"> </td> <td colspan="3" width="270"> <p>Forthe three months ended September 30,</p> </td> <td colspan="2" width="65" valign="top"> </td> <td colspan="3" width="252" valign="top"> <p>Forthe nine months ended September 30,</p> </td> </tr> <tr> <td width="439"> </td> <td width="128"> <p>2024</p> </td> <td width="28"> </td> <td width="114"> <p>2023</p> </td> <td width="47"> </td> <td colspan="2" width="126"> <p>2024</p> </td> <td width="26"> </td> <td width="118"> <p>2023</p> </td> </tr> <tr> <td width="439"> <p>Revenue </p> </td> <td width="128" valign="bottom"> <p>1,266</p> </td> <td width="28"> </td> <td width="114" valign="bottom"> <p>976</p> </td> <td width="47"> </td> <td colspan="2" width="126" valign="bottom"> <p>3,258</p> </td> <td width="26"> </td> <td width="118" valign="bottom"> <p>2,524</p> </td> </tr> <tr> <td width="439"> <p>Costof goods sold </p> </td> <td width="128" valign="bottom"> <p>(482)</p> </td> <td width="28" valign="bottom"> </td> <td width="114" valign="bottom"> <p>(336)</p> </td> <td width="47" valign="bottom"> </td> <td colspan="2" width="126" valign="bottom"> <p>(1,217)</p> </td> <td width="26" valign="bottom"> </td> <td width="118" valign="bottom"> <p>(930)</p> </td> </tr> <tr> <td width="439"> <p>Grossprofit </p> </td> <td width="128" valign="bottom"> <p>€784</p> </td> <td width="28"> </td> <td width="114" valign="bottom"> <p>€640</p> </td> <td width="47"> </td> <td colspan="2" width="126" valign="bottom"> <p>€2,041</p> </td> <td width="26"> </td> <td width="118" valign="bottom"> <p>€1,594</p> </td> </tr> <tr> <td width="439"> <p>Researchand Development Expense </p> </td> <td width="128" valign="bottom"> <p>(7,902)</p> </td> <td width="28" valign="bottom"> </td> <td width="114" valign="bottom"> <p>(6,568)</p> </td> <td width="47" valign="bottom"> </td> <td colspan="2" width="126" valign="bottom"> <p>(22,573)</p> </td> <td width="26" valign="bottom"> </td> <td width="118" valign="bottom"> <p>(19,330)</p> </td> </tr> <tr> <td width="439"> <p>Selling,General and Administrative Expense </p> </td> <td width="128" valign="bottom"> <p>(8,042)</p> </td> <td width="28"> </td> <td width="114" valign="bottom"> <p>(5058)</p> </td> <td width="47"> </td> <td colspan="2" width="126" valign="bottom"> <p>(20,396)</p> </td> <td width="26"> </td> <td width="118" valign="bottom"> <p>(16,794)</p> </td> </tr> <tr> <td width="439"> <p>Otherincome/(expense) </p> </td> <td width="128" valign="bottom"> <p>180</p> </td> <td width="28"> </td> <td width="114" valign="bottom"> <p>−</p> </td> <td width="47"> </td> <td colspan="2" width="126" valign="bottom"> <p>430</p> </td> <td width="26"> </td> <td width="118" valign="bottom"> <p>265</p> </td> </tr> <tr> <td width="439"> <p>Operatingloss for the period </p> </td> <td width="128" valign="bottom"> <p>€(14,980)</p> </td> <td width="28" valign="bottom"> </td> <td width="114" valign="bottom"> <p>€(10,986)</p> </td> <td width="47" valign="bottom"> </td> <td colspan="2" width="126" valign="bottom"> <p>€(40,498)</p> </td> <td width="26" valign="bottom"> </td> <td width="118" valign="bottom"> <p>€(34,265)</p> </td> </tr> <tr> <td width="439"> <p>Financialincome </p> </td> <td width="128" valign="bottom"> <p>1,138</p> </td> <td width="28"> </td> <td width="114" valign="bottom"> <p>2,178</p> </td> <td width="47"> </td> <td colspan="2" width="126" valign="bottom"> <p>4,615</p> </td> <td width="26"> </td> <td width="118" valign="bottom"> <p>3,592</p> </td> </tr> <tr> <td width="439"> <p>Financialexpense </p> </td> <td width="128" valign="bottom"> <p>(3,043)</p> </td> <td width="28" valign="bottom"> </td> <td width="114" valign="bottom"> <p>(1,033)</p> </td> <td width="47" valign="bottom"> </td> <td colspan="2" width="126" valign="bottom"> <p>(5,480)</p> </td> <td width="26" valign="bottom"> </td> <td width="118" valign="bottom"> <p>(2,765)</p> </td> </tr> <tr> <td width="439"> <p>Lossfor the period before taxes </p> </td> <td width="128" valign="bottom"> <p>€(16,885)</p> </td> <td width="28"> </td> <td width="114" valign="bottom"> <p>€(9,841)</p> </td> <td width="47"> </td> <td colspan="2" width="126" valign="bottom"> <p>€(41,363)</p> </td> <td width="26"> </td> <td width="118" valign="bottom"> <p>€(33,438)</p> </td> </tr> <tr> <td width="439"> <p>Incometaxes </p> </td> <td width="128" valign="bottom"> <p>(173)</p> </td> <td width="28" valign="bottom"> </td> <td width="114" valign="bottom"> <p>2,229</p> </td> <td width="47" valign="bottom"> </td> <td colspan="2" width="126" valign="bottom"> <p>(724)</p> </td> <td width="26" valign="bottom"> </td> <td width="118" valign="bottom"> <p>1,119</p> </td> </tr> <tr> <td width="439"> <p>Lossfor the period </p> </td> <td width="128" valign="bottom"> <p>€(17,058)</p> </td> <td width="28"> </td> <td width="114" valign="bottom"> <p>€(7,612)</p> </td> <td width="47"> </td> <td colspan="2" width="126" valign="bottom"> <p>€(42,087)</p> </td> <td width="26"> </td> <td width="118" valign="bottom"> <p>€(32,319)</p> </td> </tr> <tr> <td width="439"> </td> <td width="128" valign="bottom"> </td> <td width="28"> </td> <td width="114" valign="bottom"> </td> <td width="47"> </td> <td colspan="2" width="126" valign="bottom"> </td> <td width="26"> </td> <td width="118" valign="bottom"> </td> </tr> <tr> <td width="439"> <p>Lossattributable to equity holders </p> </td> <td width="128" valign="bottom"> <p>€(17,058)</p> </td> <td width="28"> </td> <td width="114" valign="bottom"> <p>€(7,612)</p> </td> <td width="47"> </td> <td colspan="2" width="126" valign="bottom"> <p>€(42,087)</p> </td> <td width="26"> </td> <td width="118" valign="bottom"> <p>€(32,319)</p> </td> </tr> <tr> <td width="439"> </td> <td width="128" valign="bottom"> </td> <td width="28" valign="bottom"> </td> <td width="114" valign="bottom"> </td> <td width="47" valign="bottom"> </td> <td colspan="2" width="126" valign="bottom"> </td> <td width="26" valign="bottom"> </td> <td width="118" valign="bottom"> </td> </tr> <tr> <td width="439"> <p>Othercomprehensive income/(loss) </p> </td> <td width="128" valign="bottom"> </td> <td width="28"> </td> <td width="114" valign="bottom"> </td> <td width="47"> </td> <td colspan="2" width="126" valign="bottom"> </td> <td width="26"> </td> <td width="118" valign="bottom"> </td> </tr> <tr> <td width="439"> <p>Itemsthat may not be subsequently reclassified to profit or loss (net of tax) </p> </td> <td width="128" valign="bottom"> </td> <td width="28" valign="bottom"> </td> <td width="114" valign="bottom"> </td> <td width="47" valign="bottom"> </td> <td colspan="2" width="126" valign="bottom"> </td> <td width="26" valign="bottom"> </td> <td width="118" valign="bottom"> </td> </tr> <tr> <td width="439"> <p>Currencytranslation differences </p> </td> <td width="128" valign="bottom"> <p>(209)</p> </td> <td width="28" valign="bottom"> </td> <td width="114" valign="bottom"> <p>(10)</p> </td> <td width="47" valign="bottom"> </td> <td colspan="2" width="126" valign="bottom"> <p>(221)</p> </td> <td width="26" valign="bottom"> </td> <td width="118" valign="bottom"> <p>(88)</p> </td> </tr> <tr> <td width="439"> <p>Totalcomprehensive loss for the year, net of tax </p> </td> <td width="128" valign="bottom"> <p>€(17,267)</p> </td> <td width="28" valign="bottom"> </td> <td width="114" valign="bottom"> <p>€(7,622)</p> </td> <td width="47"> </td> <td colspan="2" width="126" valign="bottom"> <p>€(42,308)</p> </td> <td width="26" valign="bottom"> </td> <td width="118" valign="bottom"> <p>€(32,407)</p> </td> </tr> <tr> <td width="439"> <p>Lossattributable to equity holders </p> </td> <td width="128" valign="bottom"> <p>€(17,267)</p> </td> <td width="28" valign="bottom"> </td> <td width="114" valign="bottom"> <p>€(7,622)</p> </td> <td width="47" valign="bottom"> </td> <td colspan="2" width="126" valign="bottom"> <p>€(42,308)</p> </td> <td width="26" valign="bottom"> </td> <td width="118" valign="bottom"> <p>(32,407)</p> </td> </tr> <tr> <td width="439"> </td> <td width="128"> </td> <td width="28"> </td> <td width="114"> </td> <td width="47" valign="bottom"> </td> <td colspan="2" width="126" valign="bottom"> </td> <td width="26"> </td> <td width="118" valign="bottom"> </td> </tr> <tr> <td width="439"> <p>Basicloss per share (in EUR) </p> </td> <td width="128"> <p>€(0.496)</p> </td> <td width="28"> </td> <td width="114"> <p>€(0.266)</p> </td> <td width="47" valign="bottom"> </td> <td colspan="2" width="126"> <p>€(1.346)</p> </td> <td width="26"> </td> <td width="118"> <p>€(1.166)</p> </td> </tr> <tr> <td width="439"> <p>Dilutedloss per share (in EUR) </p> </td> <td width="128"> <p>€(0.496)</p> </td> <td width="28"> </td> <td width="114"> <p>€(0.266)</p> </td> <td width="47"> </td> <td colspan="2" width="126"> <p>€(1.346)</p> </td> <td width="26"> </td> <td width="118"> <p>€(1.166)</p> </td> </tr> <tr height="0"> <td width="439"></td> <td width="128"></td> <td width="28"></td> <td width="114"></td> <td width="47"></td> <td width="18"></td> <td width="108"></td> <td width="26"></td> <td width="118"></td> </tr></tbody> </table><p>CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)</p> <p>(in thousands)</p> <table border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td width="585" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td colspan="3" width="276" valign="bottom"> <p>Asat</p> </td> </tr> <tr> <td width="585" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>September 30,<br /> 2024</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>December31, 2023</p> </td> </tr> <tr> <td width="585"> <p>ASSETS</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> </td> </tr> <tr> <td width="585"> <p>Non-currentassets</p> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> </td> </tr> <tr> <td width="585"> <p>Property,plant and equipment</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>4,461</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>4,188</p> </td> </tr> <tr> <td width="585"> <p>Intangibleassets</p> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>49,558</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>46,608</p> </td> </tr> <tr> <td width="585"> <p>Rightof use assets</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>3,635</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>3,788</p> </td> </tr> <tr> <td width="585"> <p>Deferredtax asset</p> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>53</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>56</p> </td> </tr> <tr> <td width="585"> <p>Otherlong-term receivables</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>1,475</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>1,166</p> </td> </tr> <tr> <td width="585"> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>€ 59,182</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>€55,806</p> </td> </tr> <tr> <td width="585"> <p>Currentassets</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> </td> </tr> <tr> <td width="585"> <p>Inventory</p> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>5,272</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>3,315</p> </td> </tr> <tr> <td width="585"> <p>Tradereceivables</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>2,504</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>2,758</p> </td> </tr> <tr> <td width="585"> <p>Otherreceivables</p> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>2,992</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>3,212</p> </td> </tr> <tr> <td width="585"> <p>Othercurrent assets</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>1,837</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>1,318</p> </td> </tr> <tr> <td width="585"> <p>Financialassets</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>42,299</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>36,138</p> </td> </tr> <tr> <td width="585"> <p>Cashand cash equivalents</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>28,678</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>21,610</p> </td> </tr> <tr> <td width="585"> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>€ 83,582</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>€68,351</p> </td> </tr> <tr> <td width="585"> <p>Totalassets</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>€ 142,764</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>€124,157</p> </td> </tr> <tr> <td width="585"> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> </td> </tr> <tr> <td width="585"> <p>EQUITYAND LIABILITIES</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> </td> </tr> <tr> <td width="585"> <p>Capitaland reserves</p> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> </td> </tr> <tr> <td width="585"> <p>Capital</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>5,908</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>4,926</p> </td> </tr> <tr> <td width="585"> <p>Sharepremium</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>290,906</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>246,127</p> </td> </tr> <tr> <td width="585"> <p>Sharebased payment reserve</p> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>8,943</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>7,661</p> </td> </tr> <tr> <td width="585"> <p>Othercomprehensive income</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>(84)</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>137</p> </td> </tr> <tr> <td width="585"> <p>Retainedloss</p> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>(200,966)</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>(160,829)</p> </td> </tr> <tr> <td width="585"> <p>Totalequity attributable to shareholders</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>104,707</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>€98,022</p> </td> </tr> <tr> <td width="585"> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> </td> </tr> <tr> <td width="585"> <p>LIABILITIES</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> </td> </tr> <tr> <td width="585"> <p>Non-currentliabilities</p> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> </td> </tr> <tr> <td width="585"> <p>Financialdebt</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>19,143</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>8,373</p> </td> </tr> <tr> <td width="585"> <p>Leaseliability</p> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>2,636</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>3,116</p> </td> </tr> <tr> <td width="585"> <p>Pensionliability</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>47</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>9</p> </td> </tr> <tr> <td width="585"> <p>Provisions</p> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>398</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>185</p> </td> </tr> <tr> <td width="585"> <p>Deferredtax liability</p> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>12</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>9</p> </td> </tr> <tr> <td width="585"> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>€22,236</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>€11,692</p> </td> </tr> <tr> <td width="585"> <p>Currentliabilities</p> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> </td> </tr> <tr> <td width="585"> <p>Financialdebt</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>399</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>364</p> </td> </tr> <tr> <td width="585"> <p>Leaseliability</p> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>1,151</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>851</p> </td> </tr> <tr> <td width="585"> <p>Tradepayables</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>7,109</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>8,108</p> </td> </tr> <tr> <td width="585"> <p>Currenttax liability</p> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>2,495</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>1,988</p> </td> </tr> <tr> <td width="585"> <p>Otherpayables</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>4,667</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>3,132</p> </td> </tr> <tr> <td width="585"> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>€ 15,821</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>€14,443</p> </td> </tr> <tr> <td width="585"> <p>Totalliabilities</p> </td> <td width="19" valign="bottom"> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>€ 38,057</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>€26,135</p> </td> </tr> <tr> <td width="585"> <p>Totalequity and liabilities</p> </td> <td width="19"> </td> <td width="19"> </td> <td width="129" valign="bottom"> <p>€ 142,764</p> </td> <td width="19" valign="bottom"> </td> <td width="129" valign="bottom"> <p>€124,157</p> </td> </tr> </tbody> </table> <p><em>Revenue</em><br /> Revenue was €1.3 million for the third quarter ending September 30, 2024, compared to €1.0 million for the third quarter ending September 30, 2023.</p> <p><em>Cost of Goods Sold</em></p> <p>Cost of goods sold was €482,000 for the three months ending September 30, 2024, representing a gross profit of €0.8 million, or gross margin of 62.0%. This compares to total cost of goods sold of €336,000 in the third quarter of 2023, for a gross profit of €0.6 million, or gross margin of 66.0%.</p> <p><em>Research and Development</em><br /> For the third quarter ending September 30, 2024, research and development expenses were €7.9 million, versus €6.6 million for the third quarter ending September 30, 2023.</p> <p><em>Operating Loss</em><br /> Total operating loss for the third quarter ending September 30, 2024, was €15.0 million versus €11.0 million in the third quarter ending September 30, 2023. This increase was primarily driven by expanded commercial activities, higher R&D investments, and ongoing clinical activities.</p> <p>Cash Position<br /> As of September 30, 2024, cash and financial assets totaled €71.0 million, compared to €57.7 million on December 31, 2023. Total cash burn was approximately €5.6 million per month during the third quarter 2024.</p> <p>Third Quarter 2024</p> <p>Nyxoah’s financial report for the third quarter 2024, including details of the consolidated results, are available on the investor page of Nyxoah’s website (https://investors.nyxoah.com/financials).</p> <p>Conference call and webcast presentation</p> <p>Company management will host a conference call to discuss financial results on Wednesday, November 6, 2024, 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: Nyxoah's Q3 2024 earnings call webcast. 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: Nyxoah’s Q3 2024 earnings call. 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>About Nyxoah</p> <p><br /> Nyxoah is reinventing sleep for the billion people that suffer from obstructive sleep apnea (OSA). We are a medical technology company that develops breakthrough treatment alternatives for OSA through neuromodulation. Our first innovation is Genio®, a battery-free hypoglossal neuromodulation device that is inserted through a single incision under the chin and controlled by a wearable. Through our commitment to innovation and clinical evidence, we have shown best-in-class outcomes for reducing OSA burden.</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 for FDA and U.S. commercialization approval.</p> <p>Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.</p> <p>Contacts:</p> <p>Nyxoah<br /> Loïc Moreau<br /> IR@nyxoah.com</p> <p>For Media<br /> In United States<br /> FINN Partners – Glenn Silver<br /> glenn.silver@finnpartners.com</p> <p>In Belgium/France<br /> Backstage Communication – Gunther De Backer<br /> gunther@backstagecom.be</p> <p>In International/Germany<br /> MC Services – Anne Hennecke<br /> nyxoah@mc-services.eu</p> <p>Attachment</p> <ul type="disc"> <li>ENGLISH_Q3 2024 Earnings PR</li> </ul> <p> *** הידיעה מופצת בעולם על ידי חברת התקשורת הבינלאומית GlobeNewswire</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>
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Nyxoah מדווחת על תוצאותיה הכספיות והתפעוליות לרבעון השלישי של 2024 Nyxoah מדווחת על תוצאותיה הכספיות והתפעוליות לרבעון השלישי של 2024 אישור FDA בדרך עד לרבעון הראשון של 2025, הצוות המסחרי בארה"ב נבנה בהתקדמות החברה ממומנת במלואה במזומנים עד אמצע 2026 מונט-סנט-גיברט, בלגיה, 6 בנובמבר 2024, (GLOBE NEWSWIRE) : Nyxoah SA (נאסד"ק/יורונקסט בריסל: NYXH) , חברת טכנולוגיות רפואיות המפתחת חלופות טיפול פורצות דרך לדום נשימה בשינה (OSA) באמצעות נוירומודולציה, דיווחה היום על תוצאותיה הכספיות והתפעוליות לרבעון השלישי של 2024. דגשים פיננסיים ותפעוליים אחרונים *הציגה תוצאות משכנעות של נתוני DREAM באגודה הבינלאומית לשינה כירורגית בספטמבר. *גייסה 24.6 מיליון אירו באמצעות תוכנית ATM מקרן ייעודית אחת לשירותי בריאות בארה"ב, מצטברת מצטרפת המאפשרת התאמות בשלבים לקראת המעבר למסחור בארה"ב והארכת יתרת המזומנים עד אמצע 2026. *חיזוק הארגון בארה"ב עם העסקתו של ג'ון לנדרי כמנהל כספים והצטרפותם של מספר מנהלים מסחריים מובילים בארה"ב. *דיווחה על מכירות של 1.3 מיליון אירו ברבעון השלישי, המייצגים צמיחה של 30% לעומת הרבעון השלישי של 2023. *יתרת מזומנים כוללת של 71.0 מיליון אירו בסוף הרבעון, 95.6 מיליון אירו פרופורמה כולל 24.6 מיליון אירו שגויסו. REGULATED INFORMATION Nyxoah Reports Third Quarter Financial and Operating Results FDA approval on track for first quarter 2025, U.S. commercial team build out in progresss Company fully funded with cash until mid 2026 Mont-Saint-Guibert, Belgium – November 6, 2024, (GLOBE NEWSWIRE)– Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the "Company"), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the third quarter of 2024. Recent Financial and Operating Highlights Presented compelling DREAMdata results at International Surgical Sleep Society in September. Raised €24.6 million through an ATMprogram from a single U.S. healthcare-dedicated fund providingincremental flexibility as we shift into U.S. commercialization andextending cash runway until mid 2026. Strengthened U.S. organizationwith the hiring of John Landry as Chief FinancialOfficer and the addition of severalkey commercial leaders in the U.S. Reported third quarter salesof €1.3 million, representing 30% growth versus thirdquarter 2023. Total cashposition of €71.0 million at the end of thequarter, €95.6 million proforma including the€24.6 million raised. "Our actions in the third quarter have further positioned us well for a successful U.S. commercial launch. On the back of the robust DREAM data presented in September, we have raised additional capital and are actively focused on building up our U.S. commercial team," commented Olivier Taelman, Nyxoah’s Chief Executive Officer. "I am more confident than ever that we have set Genio up for a strong commercial start in the U.S. immediately after FDA approval." Third Quarter 2024 Results CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited) (in thousands) Forthe three months ended September 30, Forthe nine months ended September 30, 2024 2023 2024 2023 Revenue 1,266 976 3,258 2,524 Costof goods sold (482) (336) (1,217) (930) Grossprofit €784 €640 €2,041 €1,594 Researchand Development Expense (7,902) (6,568) (22,573) (19,330) Selling,General and Administrative Expense (8,042) (5058) (20,396) (16,794) Otherincome/(expense) 180 − 430 265 Operatingloss for the period €(14,980) €(10,986) €(40,498) €(34,265) Financialincome 1,138 2,178 4,615 3,592 Financialexpense (3,043) (1,033) (5,480) (2,765) Lossfor the period before taxes €(16,885) €(9,841) €(41,363) €(33,438) Incometaxes (173) 2,229 (724) 1,119 Lossfor the period €(17,058) €(7,612) €(42,087) €(32,319) Lossattributable to equity holders €(17,058) €(7,612) €(42,087) €(32,319) Othercomprehensive income/(loss) Itemsthat may not be subsequently reclassified to profit or loss (net of tax) Currencytranslation differences (209) (10) (221) (88) Totalcomprehensive loss for the year, net of tax €(17,267) €(7,622) €(42,308) €(32,407) Lossattributable to equity holders €(17,267) €(7,622) €(42,308) (32,407) Basicloss per share (in EUR) €(0.496) €(0.266) €(1.346) €(1.166) Dilutedloss per share (in EUR) €(0.496) €(0.266) €(1.346) €(1.166) CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited) (in thousands) Asat September 30, 2024 December31, 2023 ASSETS Non-currentassets Property,plant and equipment 4,461 4,188 Intangibleassets 49,558 46,608 Rightof use assets 3,635 3,788 Deferredtax asset 53 56 Otherlong-term receivables 1,475 1,166 € 59,182 €55,806 Currentassets Inventory 5,272 3,315 Tradereceivables 2,504 2,758 Otherreceivables 2,992 3,212 Othercurrent assets 1,837 1,318 Financialassets 42,299 36,138 Cashand cash equivalents 28,678 21,610 € 83,582 €68,351 Totalassets € 142,764 €124,157 EQUITYAND LIABILITIES Capitaland reserves Capital 5,908 4,926 Sharepremium 290,906 246,127 Sharebased payment reserve 8,943 7,661 Othercomprehensive income (84) 137 Retainedloss (200,966) (160,829) Totalequity attributable to shareholders 104,707 €98,022 LIABILITIES Non-currentliabilities Financialdebt 19,143 8,373 Leaseliability 2,636 3,116 Pensionliability 47 9 Provisions 398 185 Deferredtax liability 12 9 €22,236 €11,692 Currentliabilities Financialdebt 399 364 Leaseliability 1,151 851 Tradepayables 7,109 8,108 Currenttax liability 2,495 1,988 Otherpayables 4,667 3,132 € 15,821 €14,443 Totalliabilities € 38,057 €26,135 Totalequity and liabilities € 142,764 €124,157 Revenue Revenue was €1.3 million for the third quarter ending September 30, 2024, compared to €1.0 million for the third quarter ending September 30, 2023. Cost of Goods Sold Cost of goods sold was €482,000 for the three months ending September 30, 2024, representing a gross profit of €0.8 million, or gross margin of 62.0%. This compares to total cost of goods sold of €336,000 in the third quarter of 2023, for a gross profit of €0.6 million, or gross margin of 66.0%. Research and Development For the third quarter ending September 30, 2024, research and development expenses were €7.9 million, versus €6.6 million for the third quarter ending September 30, 2023. Operating Loss Total operating loss for the third quarter ending September 30, 2024, was €15.0 million versus €11.0 million in the third quarter ending September 30, 2023. This increase was primarily driven by expanded commercial activities, higher R&D investments, and ongoing clinical activities. Cash Position As of September 30, 2024, cash and financial assets totaled €71.0 million, compared to €57.7 million on December 31, 2023. Total cash burn was approximately €5.6 million per month during the third quarter 2024. Third Quarter 2024 Nyxoah’s financial report for the third quarter 2024, including details of the consolidated results, are available on the investor page of Nyxoah’s website (https://investors.nyxoah.com/financials). Conference call and webcast presentation Company management will host a conference call to discuss financial results on Wednesday, November 6, 2024, 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 Q3 2024 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 Q3 2024 earnings call. 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. About Nyxoah Nyxoah is reinventing sleep for the billion people that suffer from obstructive sleep apnea (OSA). We are a medical technology company that develops breakthrough treatment alternatives for OSA through neuromodulation. Our first innovation is Genio®, a battery-free hypoglossal neuromodulation device that is inserted through a single incision under the chin and controlled by a wearable. Through our commitment to innovation and clinical evidence, we have shown best-in-class outcomes for reducing OSA burden. 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 for FDA and U.S. commercialization approval. Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States. Contacts: Nyxoah Loïc Moreau IR@nyxoah.com For Media In United States FINN Partners – Glenn Silver glenn.silver@finnpartners.com In Belgium/France Backstage Communication – Gunther De Backer gunther@backstagecom.be In International/Germany MC Services – Anne Hennecke nyxoah@mc-services.eu Attachment ENGLISH_Q3 2024 Earnings PR *** 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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