Nyxoah (NYXH) Q1 2025 Earnings Call May 14, 2025 08:00 AM ET Speaker0 Good day and thank you for standing by. Welcome to the Nixoa First Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Pearson Dennis, Investor Relations Associate. Please go ...

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 consens ...

Core Insights - Nyxoah is on track for anticipated PMA approval of its Genio® system in the second quarter of 2025, having successfully completed FDA validation requirements and currently undergoing final site inspection [2][4][17] - The company reported a revenue of €1.1 million for Q1 2025, a decrease from €1.2 million in Q1 2024, with a gross profit margin of 61.8% [5][10][11] - Significant increases in research and development expenses (€9.0 million) and selling, general and administrative expenses (€12.4 million) were noted, contributing to an operating loss of €20.6 million for Q1 2025 [12][13][14] Financial Performance - Revenue for Q1 2025 was €1.1 million, down from €1.2 million in Q1 2024 [10] - Cost of goods sold was €406,000, resulting in a gross profit of €658,000 [11] - Research and development expenses rose to €9.0 million from €7.2 million year-over-year [12] - Selling, general and administrative expenses increased to €12.4 million from €6.0 million year-over-year [13] - The operating loss for Q1 2025 was €20.6 million, compared to €12.2 million in Q1 2024 [14] Cash Position - As of March 31, 2025, cash, cash equivalents, and financial assets totaled €63.0 million, down from €85.6 million at the end of 2024 [15] Regulatory Progress - The FDA issued an Approvable Letter for Nyxoah's PMA application for the Genio® system, indicating that the application meets the necessary requirements [6][17] - The final step before full PMA approval is an on-site inspection of the U.S. manufacturing site, which has already passed a previous inspection with no deficiencies [4][18] Company Overview - Nyxoah focuses on developing innovative solutions for Obstructive Sleep Apnea (OSA), with its lead product being the Genio® system, a hypoglossal neurostimulation therapy [21] - The company received its European CE Mark for the Genio® system in 2019 and has conducted successful IPOs on Euronext Brussels and NASDAQ [22]

NEW YORK, May 13, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Nyxoah S.A. (“Nyxoah” or the “Company”) (NASDAQ: NYXH). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Nyxoah and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On March 25, 2025, Nyxoa ...

REGULATED INFORMATIONMay 9, 2025, 7:00am CET / 1:00am ET NYXOAH SA(Euronext Brussels: NYXH) Rue Edouard Belin 12, 1435 Mont-Saint-Guibert, Belgium(hereinafter the “Company”) Invitation to attend the annual and the extraordinary shareholders’ meetings of the Company to be held on June 11, 2025 The board of directors of the Company is pleased to invite its securities holders to attend the annual shareholders' meeting of the Company, to be held on Wednesday, June 11, 2025 at 2:00 p.m. CET at the Company's seat ...

Nyxoah to Release First Quarter 2025 Financial Results on May 14, 2025 Mont-Saint-Guibert, Belgium – Wednesday May 7, 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 release financial results for the first quarter of 2025 on Wednesday, May 14, 2025. Company management will host a conference call to discuss f ...

NEW YORK, May 05, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Nyxoah S.A. (“Nyxoah” or the “Company”) (NASDAQ: NYXH).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Nyxoah and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On March 25, 2025, Nyx ...

Core Points - Nyxoah SA announced a conditional issuance of up to 5 million ordinary shares under its existing at-the-market equity offering programs [3] - The total number of ordinary shares that can be sold and issued under the Company's ATM has increased to 5,662,694, which includes 662,694 shares remaining from a previous issuance decision made on December 22, 2022 [3][4] - The shares may be sold at prevailing USD market prices on the Nasdaq Global Market at the time of sale [4]

Core Viewpoint - Nyxoah is nearing full FDA approval for its Genio system, with expectations to meet final requirements in the second quarter of 2025 [1][4]. Group 1: FDA Approval Process - On March 26, 2025, the FDA issued an Approvable Letter for Nyxoah's Pre-Market Approval (PMA) application for the Genio system [2]. - The Approvable Letter indicates that the application substantially meets FDA requirements, pending satisfactory completion of a review of manufacturing facilities and methods [3]. - Nyxoah is addressing one remaining item related to the validation of a process at its U.S. manufacturing site, which is expected to be completed soon [4]. Group 2: Company Background and Product Information - Nyxoah specializes in developing innovative treatments for Obstructive Sleep Apnea (OSA) through neuromodulation, with the Genio system being a leadless and battery-free hypoglossal neurostimulation therapy [6]. - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [7]. - The company has conducted successful IPOs on Euronext Brussels in September 2020 and NASDAQ in July 2021, and has expanded its therapeutic indications based on positive study outcomes [7].

NEW YORK, April 07, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of  Nyxoah S.A. (“Nyxoah” or the “Company”) (NASDAQ: NYXH).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Nyxoah and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On March 25, 2025, N ...