Financial Data and Key Metrics Changes - The company recorded deferred revenue of €600,000 in Q4 2024, with recognized revenue of €1.3 million for the quarter and €4.5 million for the full year 2024 [27][28] - Total operating loss for Q4 2024 was €18.3 million, compared to €10.8 million in Q4 2023, driven by increased R&D spending and commercial investments in the U.S. [28] - Cash position improved to €85.6 million at the end of 2024, up from €57.7 million at the end of 2023 [28] Business Line Data and Key Metrics Changes - Revenue for Q4 2024 would have been €1.9 million excluding the impact of deferred revenue, representing a 46% sequential growth over Q3 2024 [23] - Full-year revenue increased by 18% to €5.1 million compared to 2023 [23] Market Data and Key Metrics Changes - The company launched Genio in the UK and UAE, with the UK expected to become one of the largest international markets due to NHS coverage [24][25] - The first successful implant in the UK generated excitement, and the company plans to expand into more hospitals [25] Company Strategy and Development Direction - The company aims to launch Genio in the U.S. by the end of March 2025, focusing on high-volume HGNS implanting centers and developing referral networks with sleep physicians [17][19] - A two-pronged strategy will be employed for market penetration, targeting both existing HGNS centers and sleep physicians managing OSA patients [17][19] - The company plans to utilize CPT code 64568 for reimbursement, which is recognized by commercial and government payers for OSA indications [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in receiving FDA approval by the end of March 2025, with ongoing discussions focused on labeling [31][50] - The company anticipates significant growth in 2025, with a focus on U.S. market entry and further international expansion [32][30] Other Important Information - The DREAM study demonstrated a strong AHI responder rate of 63.5% and an ODI responder rate of 71.3%, with a median AHI reduction of 70.8% [8][12] - Genio's safety profile showed an 8.7% severe adverse event rate, which is expected to positively influence therapy selection by physicians [14] Q&A Session Summary Question: Update on reimbursement and CPT code 64568 - Management acknowledged that while the reimbursement level may not be overly attractive, having a recognized CPT code is crucial for market entry [36][38] Question: Trajectory of U.S. launch and account openings - Management indicated that they are targeting approximately 300 to 350 high-volume HGNS sites for initial account openings, with plans to scale up quarterly [40][44] Question: Confidence in FDA approval timeline - Management remains confident in the March approval timeline, citing a 90-day review clock and positive interactions with the FDA [49][50] Question: Manufacturing and supply chain readiness - Management confirmed that they have sufficient manufacturing capacity and inventory for the U.S. market, with products being manufactured domestically [63][64] Question: Need for real-world data post-approval - Management plans to collect real-world data as part of their post-market study to support clinical and economic justification [70][71] Question: Key differentiators for Genio versus competitors - Management highlighted the benefits of bilateral stimulation and the ability to upgrade the system without additional surgery as key differentiators [78][80] Question: Timing of DREAM publication and ACCCESS enrollment - Management expects the DREAM study publication in a leading medical journal in the coming months and anticipates completing ACCCESS enrollment by mid-2025 [83][84]

Nyxoah SA (NASDAQ:NYXH) Q4 2024 Earnings Conference Call March 13, 2025 8:00 AM ET Company Participants John Landry - Chief Financial Officer Olivier Taelman - CEO Conference Call Participants Adam Maeder - Piper Sandler Jon Block - Stifel Matthew Park - Cantor Fitzgerald Suraj Kalia - Oppenheimer & Co. David Rescott - Baird Paige Chamberlain - Wolfe Research Operator Hello, and welcome to Nyxoah Fourth Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. After th ...

Nyxoah SA (NYXH) came out with a quarterly loss of $0.49 per share versus the Zacks Consensus Estimate of a loss of $0.50. This compares to loss of $0.41 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 2%. A quarter ago, it was expected that this company would post a loss of $0.46 per share when it actually produced a loss of $0.55, delivering a surprise of -19.57%.Over the last four quarters, the company has surpassed consens ...

Core Insights - Nyxoah reported financial and operational results for Q4 and FY 2024, highlighting a transformative year with significant advancements in their product and market strategy [1][3][4] Financial Performance - Q4 2024 revenue was €1.3 million, with deferred revenue accounting for €0.6 million; without this deferral, revenue would have been €1.9 million, a 46% increase from Q3 2024 [4] - Full year 2024 revenue reached €4.5 million, an 18% increase from €4.3 million in 2023, driven by the commercialization of the Genio® system, particularly in Germany [4] - Gross profit for Q4 2024 was €0.9 million, resulting in a gross margin of 73%, compared to a gross margin of 60% in Q4 2023 [5][6] - Total operating loss for Q4 2024 was €18.3 million, up from €10.8 million in Q4 2023, primarily due to increased R&D and commercial expenses [10] Research and Development - R&D expenses for Q4 2024 were €11.7 million, compared to €7.3 million in Q4 2023; for the full year, R&D expenses totaled €34.3 million, up from €26.7 million in 2023 [7] Selling, General and Administrative Expenses - Selling, general and administrative expenses for Q4 2024 were €8.1 million, an increase from €4.9 million in Q4 2023; for the full year, these expenses were €28.5 million, compared to €21.7 million in 2023 [8][9] Cash Position - As of December 31, 2024, cash and financial assets totaled €85.6 million, an increase from €57.7 million at the end of 2023 [11] Market Position and Future Outlook - The company is positioned for a U.S. commercial launch of the Genio® system in March 2025, with FDA approval expected by the end of Q1 2025 [1][3]

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 f ...

Nyxoah to Release Fourth Quarter and Financial Year 2024 Financial Results on March 13, 2025 Mont-Saint-Guibert, Belgium – Monday, March 10, 2025, 10:05pm CET / 5:05pm 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 fourth quarter and financial year 2024 on Thursday, March 13, 2025. Company management ...

Core Insights - Nyxoah will participate in the Oppenheimer 35 Annual Healthcare MedTech & Services Conference from March 17 to 20, 2025 [1] - CEO Olivier Taelman will present on March 17, 2025, at 8:40am ET, with a webcast available for investors [2] - The company focuses on innovative treatments for Obstructive Sleep Apnea (OSA) through neuromodulation [3] Company Overview - Nyxoah develops breakthrough treatment alternatives for OSA, with its first product being the Genio® device, which is battery-free and inserted through a single incision [3] - The Genio® system received its European CE Mark in 2019 after the successful BLAST OSA study [4] - The company has completed two IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [4] - Following positive outcomes from the BETTER SLEEP study, Nyxoah expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients [4] - The company also announced positive results from the DREAM IDE pivotal study, which is aimed at FDA and U.S. commercialization approval [4]

Core Insights - Nyxoah has announced the commercial launch of its Genio system in the Middle East, with the first successful implant performed at Saudi German Hospital in Dubai [1][2] - The Genio system is a breakthrough therapy for Obstructive Sleep Apnea (OSA) that utilizes neuromodulation and is designed for patients who cannot tolerate CPAP [2][3] - The launch represents a historic milestone as the first neurostimulation therapy for OSA in the region, aiming to expand access and transform treatment options for patients [2][4] Company Overview - Nyxoah is a medical technology company focused on developing innovative treatment alternatives for OSA through neuromodulation [3] - The Genio device is a battery-free hypoglossal neuromodulation system that is inserted through a single incision and controlled by a wearable device [3] - The company has demonstrated best-in-class outcomes for reducing the burden of OSA through its commitment to innovation and clinical evidence [3] Regulatory and Market Developments - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [4] - Nyxoah has completed two successful IPOs, first on Euronext Brussels in September 2020 and then on NASDAQ in July 2021 [4] - The company has received CE mark approval for expanding therapeutic indications to patients with Complete Concentric Collapse (CCC), which are currently contraindicated in competitors' therapies [4]

Core Insights - Nyxoah has announced the commercial launch of its Genio® system in the Middle East, with the first successful implantation performed at Saudi German Hospital in Dubai [1][6] - Genio is a neuromodulation device designed to treat Obstructive Sleep Apnea (OSA) for patients who cannot tolerate CPAP therapy, marking a significant advancement in treatment options [1][2] - The launch in the UAE represents a historic milestone as the first neurostimulation therapy for OSA in the region, with strong clinical evidence supporting its effectiveness [1][3] Company Overview - Nyxoah is focused on developing innovative treatment alternatives for OSA through neuromodulation, with Genio being its flagship product [2] - The Genio device is battery-free and is inserted through a single incision under the chin, controlled by a wearable device, showcasing the company's commitment to patient-centric solutions [2] - The company has received CE Mark approval for Genio in Europe and is pursuing FDA approval for commercialization in the U.S. following successful clinical studies [3]

Group 1 - The company Nyxoah is expected to revolutionize the treatment of Obstructive Sleep Apnea with its Genio implant, pending FDA approval in Q1 2025, which could act as a catalyst for share price movement [3] - The investment focus is on undervalued and disliked companies with strong fundamentals and cash flows, particularly in sectors like Oil & Gas and consumer goods [1] - The analyst expresses a long-term value investing approach while also engaging in deal arbitrage opportunities, indicating a diverse investment strategy [1] Group 2 - The article emphasizes the importance of connecting with like-minded investors to share insights and foster a collaborative investment community [1] - There is a clear preference for companies and industries that are misunderstood or overlooked, suggesting potential for substantial returns [1] - The analyst has a beneficial long position in Nyxoah, indicating confidence in the company's future performance [4]