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]

Core Insights - Nyxoah has announced the commercial launch of its Genio system in England, with successful implants performed at University College London Hospitals (UCLH) [1][3] - The Genio system is now covered under the NHS Specialised Services Devices Programme (SSDP), facilitating access to innovative therapies [2] - The Genio device is a battery-free hypoglossal neuromodulation system designed to treat Obstructive Sleep Apnea (OSA) [4] Company Overview - Nyxoah is focused on developing breakthrough treatment alternatives for OSA through neuromodulation, aiming to address the needs of the billion people suffering from this condition [4] - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [5] - Nyxoah has completed two successful IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [5] Clinical Milestones - The first two patients were implanted with the Genio system by Mr. Ryan Chin Taw Cheong at UCLH, marking a significant milestone for the company [3] - The company has received CE mark approval for expanding therapeutic indications to include Complete Concentric Collapse (CCC) patients, which are currently contraindicated in competitors' therapies [5] - Positive outcomes from the DREAM IDE pivotal study have been announced, supporting FDA and U.S. commercialization approval [5]

Core Insights - Nyxoah has announced the commercial launch of its Genio system in England, with successful implants performed at University College London Hospitals (UCLH) [1][3] - The Genio system is now covered under the NHS Specialised Services Devices Programme (SSDP), facilitating access to innovative therapies [2] Company Overview - Nyxoah is a medical technology company focused on developing neuromodulation treatment alternatives for Obstructive Sleep Apnea (OSA), with its first product being the Genio system [4] - The Genio device is a battery-free hypoglossal neuromodulation device that is inserted through a single incision under the chin and controlled by a wearable [4] Clinical Milestones - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [5] - Positive outcomes from the BETTER SLEEP study led to the expansion of therapeutic indications for Genio to include Complete Concentric Collapse (CCC) patients, which are currently contraindicated in competitors' therapies [5] - The company has also announced positive results from the DREAM IDE pivotal study, which is aimed at obtaining FDA approval for U.S. commercialization [5]

Core Points - Nyxoah will participate in the Piper Sandler 36th Annual Healthcare Conference on December 4, 2024, presenting at 2:00pm ET via webcast [1][2] - The company focuses on developing innovative treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation [3] - Nyxoah's flagship product, Genio®, is a battery-free hypoglossal neuromodulation device that has shown best-in-class outcomes for reducing OSA burden [3] Company Overview - Nyxoah aims to address the needs of the billion people suffering from OSA by providing breakthrough treatment options [3] - The Genio® system received its European CE Mark in 2019 following the successful BLAST OSA study [4] - The company has completed two successful 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, which are currently contraindicated in competitors' therapies [4] - The company also announced positive outcomes from the DREAM IDE pivotal study, which is aimed at obtaining FDA approval for U.S. commercialization [4]

Financial Data and Key Metrics Changes - Revenue for Q3 2024 was €1.3 million, with an operating loss of €15 million compared to €11 million in Q3 2023, driven by increased commercial investments in the U.S. [30] - Cash and financial assets totaled €71 million as of September 30, 2024, with a monthly cash burn of €5.6 million during the quarter [31]. Business Line Data and Key Metrics Changes - The company has focused on strengthening its U.S. presence in anticipation of the Genio product launch, including hiring key executive roles [10][12]. - The DREAM study demonstrated strong efficacy with an AHI response rate of 63.5% on an intent-to-treat basis and 66.4% on a modified intent-to-treat basis [13]. Market Data and Key Metrics Changes - The company has achieved a 25% overall market share in the German market within 24 months of launch, which serves as a model for U.S. market entry [28]. - The U.S. hypoglossal nerve stimulation market is experiencing strong growth, with estimates of over 30% growth [63]. Company Strategy and Development Direction - The company is preparing for a U.S. commercial launch with a two-pronged strategy focusing on Tier 1 implanting accounts and driving referrals from sleep physicians [24][54]. - The reimbursement strategy includes using an established CPT code recognized by payers for OSA indications at launch, with plans to pursue a Genio-specific CPT code over time [39][80]. Management's Comments on Operating Environment and Future Outlook - Management anticipates FDA approval for Genio in Q1 2025, citing delays in site inspections as a reason for the revised timeline [50]. - The company is confident in its ability to meet demand from a supply standpoint, with two manufacturing sites operational [73]. Other Important Information - The company raised €24.6 million in October 2024 to strengthen its balance sheet ahead of the U.S. commercialization [9]. - The company has established a dedicated team to support preauthorization efforts at the site level post-FDA approval [22]. Q&A Session Summary Question: Feedback from clinicians on DREAM data - Positive feedback was received regarding the unique requirement for patients to sleep in a supine position, with comparable efficacy to non-supine positions [35][36]. Question: Details on reimbursement and CPT code - The company is executing a comprehensive reimbursement strategy, confirming the use of an established CPT code at launch [39][40]. Question: Timing of peer-reviewed publication of DREAM data - The publication is being prepared by the principal investigator and is expected in the coming weeks [45]. Question: Changes in FDA approval timeline - The timeline has shifted to Q1 2025 due to delays in the Belgium site inspection [50]. Question: Commercialization strategy and Tier 1 accounts - The company will focus on high-volume Tier 1 accounts, which represent 80% of current revenue [71]. Question: Confidence in supply meeting demand - The company has two operational manufacturing sites and sufficient inventory to serve both U.S. and European markets [73].

Core Insights - Nyxoah SA reported a quarterly loss of $0.68 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.46, marking an earnings surprise of -47.83% [1] - The company generated revenues of $1.73 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 17.72% and showing an increase from $1.06 million year-over-year [2] - Nyxoah shares have appreciated approximately 114.4% since the beginning of the year, significantly outperforming the S&P 500's gain of 21.2% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.45 on revenues of $2.74 million, while for the current fiscal year, the estimate is -$1.86 on revenues of $6.39 million [7] - The estimate revisions trend for Nyxoah is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [6] Industry Context - The Medical Info Systems industry, to which Nyxoah belongs, is currently ranked in the top 34% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Another company in the same industry, Definitive Healthcare Corp., is expected to report results soon, with a consensus EPS estimate of $0.08 per share, reflecting a year-over-year decline of 11.1% [9]