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]

Core Insights - Nyxoah has appointed John Landry as Chief Financial Officer, effective November 4, 2024, to enhance its focus on the U.S. market [1][3] - Loïc Moreau, the current CFO, will transition to the newly created role of President International, leading global expansion efforts [3][4] Company Overview - Nyxoah is a medical technology company focused on developing innovative treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation [5] - The company's flagship product, Genio®, is a battery-free hypoglossal neuromodulation device designed for OSA treatment [5] Leadership Experience - John Landry brings over 20 years of financial leadership experience in the healthcare and medtech sectors, previously serving as CFO at Vapotherm Inc., where he contributed to significant revenue growth in the U.S. market [2][3] Strategic Goals - The appointment of John Landry is aimed at optimizing financial strategies and driving operational efficiencies as Nyxoah prepares Genio for commercialization in the U.S. [3] - The company is committed to building a strong leadership team to support its ambitious growth objectives [4] Regulatory Milestones - Genio® received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [6] - Nyxoah has completed two successful IPOs, on Euronext Brussels in September 2020 and NASDAQ in July 2021 [6] - The company has received CE mark approval for expanding therapeutic indications to Complete Concentric Collapse (CCC) patients, which are currently contraindicated in competitors' therapies [6]

Nyxoah to Release Third Quarter 2024 Financial Results on November 6, 2024 Mont-Saint-Guibert, Belgium – October 22, 2024, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the Company will release financial results for the third quarter 2024 on Wednesday, November 6, 2024, after market close. Compan ...

INSIDE INFORMATION REGULATED INFORMATION Nyxoah Raises $27 Million through its At-the-Market Offering Investment by a new U.S.-based healthcare investor, strengthening the balance sheet and reinforcing U.S. focus Mont-Saint-Guibert, Belgium – October 7, 2024, 11:00pm CET / 5:00pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the "Company"), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced ...

Exhibit 99.1 Publication relating to transparency notifications September 27, 2024 REGULATED INFORMATION Publication relating to transparency notifications Mont-Saint-Guibert (Belgium), September 27, 2024, 8.00am CET / 2.00am ET – In accordance with article 14 of the Act of 2 May 2007 on the disclosure of large shareholdings, Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) announces that it received a transparency notification as detailed below. BlackRock, Inc. On September 24, 2024, Nyxoah received a transparen ...

Nyxoah to Participate in Upcoming Investor Conferences Mont-Saint-Guibert, Belgium – September 5, 2024, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the "Company"), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the Company will participate in three upcoming investor conferences in New York City. Olivier Taelman, Nyxoah's Chief Executive Officer, will deliv ...

Nyxoah Rings the Closing Bell at Nasdaq while Preparing for U.S. Market Launch of Innovative Sleep Apnea Device FDA regulatory submission for the Company's Genio® device is complete, U.S. approval on track for the end of 2024 U.S. commercial launch, expected at the beginning of 2025, fully funded with over €85 million in new capital raised Nyxoah – NASDAQ Closing Bell Ceremony 29 août 2024 Mont-Saint-Guibert, Belgium – September 2, 2024 10:05pm CET / 4:05PM ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (" ...

Nyxoah S.A. (NASDAQ:NYXH) Q2 2024 Earnings Conference Call August 6, 2024 4:30 PM ET Company Participants Mikaela Kirkwood - Corporate Communications and Investor Relations Manager Olivier Taelman - CEO Loic Moreau - CFO Conference Call Participants Suraj Kalia - Oppenheimer Edward White - H.C. Wainwright Joseph Federico - Stifel Ross Osborn - Cantor Fitzgerald David Rescott - Baird Operator Good day, everyone, and thank you for standing by. Welcome to Nyxoah Second Quarter 2024 Earnings Conference Call. [O ...

Nyxoah SA (NYXH) came out with a quarterly loss of $0.46 per share versus the Zacks Consensus Estimate of a loss of $0.45. This compares to loss of $0.49 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -2.22%. A quarter ago, it was expected that this company would post a loss of $0.45 per share when it actually produced a loss of $0.45, delivering no surprise. Over the last four quarters, the company has surpassed consensus E ...