Latest news with #OlivierTaelman
Bahrain News Gazette
08-04-2025
- Business
- Bahrain News Gazette
Nyxoah Provides Update on FDA Approvable Letter for Genio System
Nyxoah Provides Update on FDA Approvable Letter for Genio System Expects to meet final FDA requirements for full PMA approval in the second quarter Mont-Saint-Guibert, Belgium – April 8, 2025, 07:00am CET / 1:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ('Nyxoah' or the 'Company'), which develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced an update on the FDA approval process for the Genio system. On March 26, 2025, the Company announced that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio® system. The Approvable Letter means that Nyxoah's application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA's PMA implementing regulations codified at 21 C.F.R. Part 814, and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review. FDA has accepted all other data provided with the PMA submission, including most importantly the clinical study that demonstrates the safety and effectiveness of the Genio® system. Nyxoah is actively addressing one remaining item before FDA approval may be granted which is the validation of one process used with a component of the Genio system at its U.S. manufacturing site. The Company is confident that it will be able to successfully complete this validation in the near term. As such, Nyxoah anticipates that its application could potentially be approved in the second quarter and intends to provide an update on the review process on its first quarter 2025 earnings call to be held in May. 'We are pleased to share that the Approvable Letter from FDA confirms that we are very close to PMA approval,' commented Olivier Taelman, Nyxoah's Chief Executive Officer. 'We believe the final remaining step is completing a process validation at our U.S. manufacturing site – action taken in response to the last set of specific validation questions sent by the FDA – which we are confident we can address swiftly and successfully. We look forward to launching Genio in the U.S. upon receipt of FDA approval.' About Nyxoah Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (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. For more information, please visit . Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States FORWARD-LOOKING STATEMENTS Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah's goals with respect to the development, regulatory pathway and potential use of the Genio® system; receipt of FDA approval; satisfactory completion of a manufacturing facilities, methods and controls review, and the anticipated timing of the foregoing; entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the 'Risk Factors' section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission ('SEC') on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Contacts: Nyxoah John Landry, CFO [email protected] For Media In United States FINN Partners – Alyssa Paldo [email protected] In International/Germany MC Services – Anne Hennecke [email protected] In Belgium/France Backstage Communication – Gunther De Backer [email protected] Attachment ENGLISH_Update on FDA Approvable Letter_FINAL GlobeNewswire Distribution ID 1001078888
Bahrain News Gazette
26-03-2025
- Business
- Bahrain News Gazette
FDA Issues Nyxoah an Approvable Letter for its Genio® System
INSIDE INFORMATION REGULATED INFORMATION FDA Issues Nyxoah an Approvable Letter for its Genio® System Mont-Saint-Guibert, Belgium – March 26, 2025, 8:00am CET / 3:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ('Nyxoah' or the 'Company'), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the U.S. Food and Drug Administration (FDA) has issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio® system. The Approvable Letter means that Nyxoah's application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA's PMA implementing regulations codified at 21 C.F.R. Part 814, and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review. The Company will work closely with the FDA to address these requests and is committed to bringing this innovative therapy to U.S. patients. 'The FDA has reviewed our submission and determined that it substantially meets the requirements for approval: the FDA's Approvable Letter included no further questions on the clinical data or biocompatibility that support the submission,' commented Olivier Taelman, Nyxoah's Chief Executive Officer. 'We are still on the right track to make Genio available to U.S. patients suffering from OSA.' This decision does not impact Genio's CE Mark or ongoing commercial activities in Europe, where the device is approved for both Complete Concentric Collapse (CCC) and non-CCC patients. About Nyxoah Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (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. For more information, please visit . Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States. FORWARD-LOOKING STATEMENTS Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah's goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; the satisfactory completion of a manufacturing facilities, methods and controls review and receipt of FDA approval; entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the 'Risk Factors' section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission ('SEC') on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Contacts: Nyxoah John Landry, CFO [email protected] For Media In United States FINN Partners – Alyssa Paldo [email protected] In International/Germany MC Services – Anne Hennecke [email protected] In Belgium/France Backstage Communication – Gunther De Backer [email protected] Attachment ENGLISH_FDA Approvable Press Release GlobeNewswire Distribution ID 1001076080
Yahoo
26-03-2025
- Health
- Yahoo
FDA Issues Nyxoah an Approvable Letter for its Genio® System
INSIDE INFORMATIONREGULATED INFORMATION FDA Issues Nyxoah an Approvable Letter for its Genio® System Mont-Saint-Guibert, Belgium – March 26, 2025, 8:00am CET / 3:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ('Nyxoah' or the 'Company'), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the U.S. Food and Drug Administration (FDA) has issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio® system. The Approvable Letter means that Nyxoah's application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA's PMA implementing regulations codified at 21 C.F.R. Part 814, and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review. The Company will work closely with the FDA to address these requests and is committed to bringing this innovative therapy to U.S. patients. 'The FDA has reviewed our submission and determined that it substantially meets the requirements for approval: the FDA's Approvable Letter included no further questions on the clinical data or biocompatibility that support the submission,' commented Olivier Taelman, Nyxoah's Chief Executive Officer. 'We are still on the right track to make Genio available to U.S. patients suffering from OSA.' This decision does not impact Genio's CE Mark or ongoing commercial activities in Europe, where the device is approved for both Complete Concentric Collapse (CCC) and non-CCC patients. About NyxoahNyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (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. For more information, please visit Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States. FORWARD-LOOKING STATEMENTS Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah's goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; the satisfactory completion of a manufacturing facilities, methods and controls review and receipt of FDA approval; entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the 'Risk Factors' section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission ('SEC') on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Contacts: NyxoahJohn Landry, CFOIR@ For MediaIn United StatesFINN Partners – Alyssa In International/GermanyMC Services – Anne Henneckenyxoah@ In Belgium/FranceBackstage Communication – Gunther De Backergunther@ ENGLISH_FDA Approvable Press Release
Bahrain News Gazette
13-03-2025
- Business
- Bahrain News Gazette
Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating Results
Mont-Saint-Guibert, Belgium – March 1 3, 2024, 7: 0 0 am CET / 2: 0 0 am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ('Nyxoah' or the 'Company'), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the fourth quarter and financial year 2024. Recent Financial and Operating Highlights Revenue for the fourth quarter of 2024 was €1.3 million, which excludes €0.6 million of deferred revenue Revenue for the full year 2024 was €4.5 million, which excludes €0.6 million of deferred revenue Gross margin for the fourth quarter of 2024 was 73% At December 31, 2024, cash and financial assets were €85.6 million, compared to €57.7 million at December 31, 2023 Assembled U.S. executive leadership team with deep industry experience Full U.S. commercial organization, including sales, marketing, and market access teams, in place '2024 was a transformative year for Nyxoah. We reported best-in-class outcomes from our DREAM pivotal study, completed our PMA submission with the FDA for Genio, and built a world-class U.S. commercial organization,' commented Olivier Taelman, Nyxoah's Chief Executive Officer. 'We believe an approval is still expected by the end of the first quarter, and we look forward to launching this innovative therapy to the millions of Americans suffering from moderate to severe OSA.' Fourth Quarter and Full Year 202 4 Results Revenue In the fourth quarter of 2024, the Company began recording a portion of the selling price for a Genio system related to disposable patches as deferred revenue and recognized €0.6 million in the quarter. Due to this deferral, reported revenue was €1.3 million for the fourth quarter ending December 31, 2024, and €4.5 million for the full year. Had the Company not recorded deferred revenue for its disposable patches, total revenue for the fourth quarter would have €1.9 million, up 46% versus the third quarter of 2024. Likewise, revenue for the full year 2024 would have been €5.1 million, up 18% from €4.3 million in 2023. The increase in full year revenue was attributable to the Company's commercialization of the Genio® system, primarily in Germany. Cost of Goods Sold Cost of goods sold was €0.3 million for the three months ending December 31, 2024, representing a gross profit of €0.9 million, or gross margin of 73%. This compares to total cost of goods sold of €0.7 million in the fourth quarter of 2023, for a gross profit of €1.1 million, or gross margin of 60%. For the full year ending December 31, 2024, total cost of goods sold was €1.5 million, representing a gross profit of €3.0 million, or gross margin of 66%. This compares to total cost of goods sold of €1.7 million for the full year of 2023, for a gross profit of €2.7 million, or gross margin of 62%. Research and Development For the fourth quarter ending December 31, 2024, research and development expenses were €11.7 million, versus €7.3 million for the fourth quarter ending December 31, 2023. For the full year ending December 31, 2024, research and development expenses were €34.3 million, versus €26.7 million for the full year of 2023. The increase in research and development expenses was primarily driven by higher R&D activities and clinical expenses. Selling, General and Administrative For the fourth quarter ending December 31, 2024, selling, general and administrative expenses were €8.1million, versus €4.9 million for the fourth quarter ending December 31, 2023. For the full year ending December 31, 2024, selling, general and administrative expenses were €28.5 million, versus €21.7 million for the full year of 2023. The increase in selling, general and administrative expenses was mainly due to an increase of costs to support the commercialization of Genio® system in Europe and scale up of the Company. Operating Loss Total operating loss for the fourth quarter and full year 2024 was €18.3 million and €58.8 million, respectively, versus €10.8 million and €45.1 million in the fourth quarter and full year 2023, respectively. This was driven by the acceleration in the Company's R&D spending, as well as ongoing commercial and clinical activities. Cash Position As of December 31, 2024, cash and financial assets totaled €85.6 million, compared to €57.7 million on December 31, 2023. Annual R eport 202 4 Nyxoah is currently finalizing the financial statements for the year ended December 31, 2024. The Company's independent auditor has confirmed that their audit procedures, which have been substantially completed, have not revealed any material adjustments which would have to be made to the accounting information included in this press release. The complete consolidated financial statements for the year ended December 31, 2024 as well as the complete audit report related to the audit of the consolidated financial statements will be included in the 2024 Annual Report which the Company aims to publish on or around March 20, 2025. When published, the Nyxoah Annual Report for the financial year 2024 will be available on the investor page of Nyxoah's website ( Conference call and webcast presentation Company management will host a conference call to discuss financial results on Thursday, March 13, 2025, beginning at 1:00pm CET / 8:00am ET. A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q4 and FY 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 Q4 and FY 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. CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (un audited) (in thousands) For the three months ended December 31, For the twelve months ended December 31, 2024 2023 2024 2023 Revenue 1 263 1 824 4 521 4 348 Cost of goods sold (335) (726) (1 552) (1 656) Gross profit € 928 € 1 098 € 2 969 € 2 692 Research and Development Expense (11 752) (7 321) (34 325) (26 651) Selling, General and Administrative Expense (8 065) (4 893) (28 461) (21 687) Other income/(expense) 578 279 1 008 544 Operating loss for the period €(18 311) €(10 837) €(58 809) €(45 102) Financial income 2 832 582 7 447 4 174 Financial expense 410 (964) (5 070) (3 729) Loss for the period before taxes €(15 069) €(11 219) €(56 432) €(44 657) Income taxes (2 080) 326 (2 804) 1 445 Loss for the period €(17 149) €(10 893) €(59 236) €(43 212) Loss attributable to equity holders €(17 149) €(10 893) €(59 236) €(43 212) Other comprehensive income/(loss) Items that may not be subsequently reclassified to profit or loss (net of tax) Remeasurements of post-employment benefit obligations, net of tax 11 81 11 81 Items that may be subsequently reclassified to profit or loss (net of tax) Currency translation differences 545 (32) 766 (120) Total other comprehensive income/(loss) € 556 €(39) €777 €(39) Total comprehensive loss for the year, net of tax €(16 151) € (10 844) €(58 459) €(43 2 5 1) Loss attributable to equity holders €(16 151) € (10 844) €(58 459) € (43 251) Basic loss per share (in EUR) €(463) €(379) €(1 809) €(1 545) Diluted loss per share (in EUR) €(463) €(379) €(1 809) €(1 545) CONSOLIDATED BALANCE SHEET (unaudited) (in thousands) As at December 31 2024 2023 ASSETS Non-current assets Property, plant and equipment 4 753 4 188 Intangible assets 50 381 46 608 Right of use assets 3 496 3 788 Deferred tax asset 76 56 Other long-term receivables 1 617 1 166 € 60 323 € 55 806 Current assets Inventory 4 716 3 315 Trade receivables 3 382 2 758 Other receivables 2 774 3 212 Other current assets 1 656 1 318 Financial assets 51 369 36 138 Cash and cash equivalents 34 186 21 610 € 98 083 € 68 351 Total assets € 158 406 € 124 157 EQUITY AND LIABILITIES Share capital and reserves Share capital 6 430 4 926 Share premium 314 345 246 127 Share based payment reserve 9 300 7 661 Other comprehensive income 914 137 Retained loss (217 735) (160 829) Total equity attributable to shareholders € 113 254 € 98 022 LIABILITIES Non-current liabilities Financial debt 18 725 8 373 Lease liability 2 562 3 116 Pension liability − 9 Provisions 1 000 185 Deferred tax liability 19 9 Contract liability 472 − Other liabilities 845 − € 23 623 € 11 692 Current liabilities Financial debt 248 364 Lease liability 1 118 851 Trade payables 9 505 8 108 Current tax liability 4 317 1 988 Contract liability 117 − Other liabilities 6 224 3 132 € 21 529 € 14 443 Total liabilities € 45 152 € 26 135 Total equity and liabilities € 158 406 € 124 157 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. For more information, please visit Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States. Forward-looking statements Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah's goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; receipt of FDA approval; entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the 'Risk Factors' section of the Company's Annual Report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission ('SEC') on March 20, 2024, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Contact s: Nyxoah John Landry – CFO [email protected] For Media United States FINN Partners – Glenn Silver [email protected] Belgium/France Backstage Communication – Gunther De Backer [email protected] International/Germany MC Services – Anne Hennecke [email protected] Attachment ENGLISH_Q4 2024 Earnings PR_FINAL
Yahoo
13-03-2025
- Business
- Yahoo
Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating Results
REGULATED INFORMATION Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating ResultsFDA PMA Application Review Nearing ConclusionPositioned for U.S. Commercial Launch in March 2025 Mont-Saint-Guibert, Belgium – March 13, 2024, 7:00am CET / 2:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ('Nyxoah' or the 'Company'), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the fourth quarter and financial year 2024. Recent Financial and Operating Highlights Revenue for the fourth quarter of 2024 was €1.3 million, which excludes €0.6 million of deferred revenue Revenue for the full year 2024 was €4.5 million, which excludes €0.6 million of deferred revenue Gross margin for the fourth quarter of 2024 was 73% At December 31, 2024, cash and financial assets were €85.6 million, compared to €57.7 million at December 31, 2023 Assembled U.S. executive leadership team with deep industry experience Full U.S. commercial organization, including sales, marketing, and market access teams, in place "2024 was a transformative year for Nyxoah. We reported best-in-class outcomes from our DREAM pivotal study, completed our PMA submission with the FDA for Genio, and built a world-class U.S. commercial organization,' commented Olivier Taelman, Nyxoah's Chief Executive Officer. 'We believe an approval is still expected by the end of the first quarter, and we look forward to launching this innovative therapy to the millions of Americans suffering from moderate to severe OSA.' Fourth Quarter and Full Year 2024 Results Revenue In the fourth quarter of 2024, the Company began recording a portion of the selling price for a Genio system related to disposable patches as deferred revenue and recognized €0.6 million in the quarter. Due to this deferral, reported revenue was €1.3 million for the fourth quarter ending December 31, 2024, and €4.5 million for the full year. Had the Company not recorded deferred revenue for its disposable patches, total revenue for the fourth quarter would have €1.9 million, up 46% versus the third quarter of 2024. Likewise, revenue for the full year 2024 would have been €5.1 million, up 18% from €4.3 million in 2023. The increase in full year revenue was attributable to the Company's commercialization of the Genio® system, primarily in Germany. Cost of Goods Sold Cost of goods sold was €0.3 million for the three months ending December 31, 2024, representing a gross profit of €0.9 million, or gross margin of 73%. This compares to total cost of goods sold of €0.7 million in the fourth quarter of 2023, for a gross profit of €1.1 million, or gross margin of 60%. For the full year ending December 31, 2024, total cost of goods sold was €1.5 million, representing a gross profit of €3.0 million, or gross margin of 66%. This compares to total cost of goods sold of €1.7 million for the full year of 2023, for a gross profit of €2.7 million, or gross margin of 62%. Research and DevelopmentFor the fourth quarter ending December 31, 2024, research and development expenses were €11.7 million, versus €7.3 million for the fourth quarter ending December 31, 2023. For the full year ending December 31, 2024, research and development expenses were €34.3 million, versus €26.7 million for the full year of 2023. The increase in research and development expenses was primarily driven by higher R&D activities and clinical expenses. Selling, General and AdministrativeFor the fourth quarter ending December 31, 2024, selling, general and administrative expenses were €8.1million, versus €4.9 million for the fourth quarter ending December 31, 2023. For the full year ending December 31, 2024, selling, general and administrative expenses were €28.5 million, versus €21.7 million for the full year of 2023. The increase in selling, general and administrative expenses was mainly due to an increase of costs to support the commercialization of Genio® system in Europe and scale up of the Company. Operating LossTotal operating loss for the fourth quarter and full year 2024 was €18.3 million and €58.8 million, respectively, versus €10.8 million and €45.1 million in the fourth quarter and full year 2023, respectively. This was driven by the acceleration in the Company's R&D spending, as well as ongoing commercial and clinical activities. Cash PositionAs of December 31, 2024, cash and financial assets totaled €85.6 million, compared to €57.7 million on December 31, 2023. Annual Report 2024Nyxoah is currently finalizing the financial statements for the year ended December 31, 2024. The Company's independent auditor has confirmed that their audit procedures, which have been substantially completed, have not revealed any material adjustments which would have to be made to the accounting information included in this press release. The complete consolidated financial statements for the year ended December 31, 2024 as well as the complete audit report related to the audit of the consolidated financial statements will be included in the 2024 Annual Report which the Company aims to publish on or around March 20, 2025. When published, the Nyxoah Annual Report for the financial year 2024 will be available on the investor page of Nyxoah's website ( Conference call and webcast presentation Company management will host a conference call to discuss financial results on Thursday, March 13, 2025, beginning at 1:00pm CET / 8:00am ET. A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q4 and FY 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 Q4 and FY 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. CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)(in thousands) For the three months ended December 31,For the twelve months ended December 31, 2024202320242023 Revenue 1 2631 8244 5214 348 Cost of goods sold (335)(726)(1 552)(1 656) Gross profit € 928€ 1 098€ 2 969€ 2 692 Research and Development Expense (11 752)(7 321)(34 325)(26 651) Selling, General and Administrative Expense (8 065)(4 893)(28 461)(21 687) Other income/(expense) 5782791 008544 Operating loss for the period €(18 311)€(10 837)€(58 809)€(45 102) Financial income 2 8325827 4474 174 Financial expense 410(964)(5 070)(3 729) Loss for the period before taxes €(15 069)€(11 219)€(56 432)€(44 657) Income taxes (2 080)326(2 804)1 445 Loss for the period €(17 149)€(10 893)€(59 236)€(43 212) Loss attributable to equity holders €(17 149)€(10 893)€(59 236)€(43 212) Other comprehensive income/(loss) Items that may not be subsequently reclassified to profit or loss (net of tax) Remeasurements of post-employment benefit obligations, net of tax 11811181 Items that may be subsequently reclassified to profit or loss (net of tax)Currency translation differences 545(32)766(120) Total other comprehensive income/(loss) €556€(39)€777€(39) Total comprehensive loss for the year, net of tax €(16 151)€ (10 844)€(58 459)€(43 251) Loss attributable to equity holders €(16 151)€ (10 844)€(58 459)€(43 251) Basic loss per share (in EUR) €(463)€(379)€(1 809)€(1 545) Diluted loss per share (in EUR) €(463)€(379)€(1 809)€(1 545)CONSOLIDATED BALANCE SHEET (unaudited)(in thousands)As at December 3120242023 ASSETSNon-current assetsProperty, plant and equipment 4 7534 188 Intangible assets 50 38146 608 Right of use assets 3 4963 788 Deferred tax asset 7656 Other long-term receivables 1 6171 166€ 60 323€ 55 806 Current assetsInventory 4 7163 315 Trade receivables 3 3822 758 Other receivables 2 7743 212 Other current assets 1 6561 318 Financial assets 51 36936 138 Cash and cash equivalents 34 18621 610€ 98 083€ 68 351 Total assets € 158 406€ 124 157 EQUITY AND LIABILITIESShare capital and reservesShare capital 6 4304 926 Share premium 314 345246 127 Share based payment reserve 9 3007 661 Other comprehensive income 914137 Retained loss (217 735)(160 829) Total equity attributable to shareholders € 113 254€ 98 022 LIABILITIESNon-current liabilitiesFinancial debt 18 7258 373 Lease liability 2 5623 116 Pension liability −9 Provisions 1 000185 Deferred tax liability 199 Contract liability 472− Other liabilities 845−€ 23 623€ 11 692 Current liabilitiesFinancial debt 248364 Lease liability 1 118851 Trade payables 9 5058 108 Current tax liability 4 3171 988 Contract liability 117− Other liabilities 6 2243 132€ 21 529€ 14 443 Total liabilities € 45 152€ 26 135 Total equity and liabilities € 158 406€ 124 157 About NyxoahNyxoah 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. For more information, please visit Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States. Forward-looking statements Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah's goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; receipt of FDA approval; entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the 'Risk Factors' section of the Company's Annual Report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission ('SEC') on March 20, 2024, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Contacts: NyxoahJohn Landry – CFOIR@ For MediaUnited StatesFINN Partners – Glenn Belgium/FranceBackstage Communication – Gunther De Backergunther@ International/GermanyMC Services – Anne Henneckenyxoah@ Attachment ENGLISH_Q4 2024 Earnings PR_FINALSign in to access your portfolio
