Latest news with #NyxoahSA
Yahoo
14-05-2025
- Business
- Yahoo
Nyxoah SA (NYXH) Reports Q1 Loss, Lags Revenue Estimates
Nyxoah SA (NYXH) came out with a quarterly loss of $0.63 per share versus the Zacks Consensus Estimate of a loss of $0.49. This compares to loss of $0.45 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -28.57%. A quarter ago, it was expected that this company would post a loss of $0.50 per share when it actually produced a loss of $0.49, delivering a surprise of 2%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Nyxoah , which belongs to the Zacks Medical Info Systems industry, posted revenues of $1.12 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 29.71%. This compares to year-ago revenues of $1.33 million. The company has not been able to beat consensus revenue estimates over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Nyxoah shares have lost about 27.8% since the beginning of the year versus the S&P 500's gain of 0.1%. While Nyxoah has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Nyxoah: mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.54 on $2.12 million in revenues for the coming quarter and -$2.25 on $15.16 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical Info Systems is currently in the top 20% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Veeva Systems (VEEV), is yet to report results for the quarter ended April 2025. The results are expected to be released on May 28. This provider of cloud-based software services for the life sciences industry is expected to post quarterly earnings of $1.74 per share in its upcoming report, which represents a year-over-year change of +16%. The consensus EPS estimate for the quarter has been revised 0.2% lower over the last 30 days to the current level. Veeva Systems' revenues are expected to be $727.99 million, up 11.9% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Nyxoah SA (NYXH) : Free Stock Analysis Report Veeva Systems Inc. (VEEV) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Bahrain News Gazette
16-04-2025
- Business
- Bahrain News Gazette
Conditional Issuance of Shares
INSIDE INFORMATION REGULATED INFORMATION Conditional Issuance of Shares Mont-Saint-Guibert, Belgium – April 16, 2025, 8:00 am CET / 2:00 am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ('Nyxoah' or the 'Company'), today announced a conditional issuance of up to 5 million ordinary shares under its existing at-the-market equity offering programs (the ' ATM '). This brings the aggregate number of ordinary shares that can be sold and issued under the Company's ATM to 5,662,694 (the ' ATM Shares '), which includes 662,694 shares that are still available from the conditional issuance of shares under the ATM decided upon on December 22, 2022. Pursuant to the existing sales agreement entered into by the Company on December 22, 2022, ATM Shares may be sold from time to time at a sales price per ATM Share equal to prevailing USD market prices of the Nyxoah ordinary share on the Nasdaq Global Market at the time of the sale. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any securities. Contacts: Nyxoah John Landry, CFO [email protected] Attachment ATM PR – ENG – FINAL GlobeNewswire Distribution ID 1001080587
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
Bahrain News Gazette
04-03-2025
- Business
- Bahrain News Gazette
Nyxoah to Participate in the Oppenheimer 35th Annual Healthcare MedTech & Services Conference
Mont-Saint-Guibert, Belgium – March 3, 2025, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ('Nyxoah' or the 'Company'), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the Company will participate in the Oppenheimer 35 th Annual Healthcare MedTech & Services Conference, which takes place March 17 – 20, 2025. Olivier Taelman, Nyxoah's Chief Executive Officer, will deliver a corporate presentation on Monday, March 17, 2025, at 8:40am ET. A webcast of the presentation will be available in the Events section of Nyxoah's Investor Relations website. The Company will be available for 1×1 meetings with institutional investors. Nyxoah's Investor Presentation can be accessed on the Shareholder Information section of the Company's Investor Relations page. 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 John Landry, CFO Attachment
