Core Viewpoint - Nyxoah is making a significant investment to expand its manufacturing capacity in Belgium to support growth in the U.S. and international markets [1][2][3] Group 1: Investment and Expansion - Nyxoah has signed an agreement with LégiaPark to create a nearly 2,000 square meters manufacturing facility, including a state-of-the-art cleanroom [2] - The investment aims to enhance Nyxoah's product development activities and strengthen its strategic partnership with Noshaq, contributing to local job creation [2][3] Group 2: Manufacturing and Technology - The new cleanroom facility is designed to be scalable, allowing for future growth alongside Nyxoah's manufacturing needs [3] - ABN Cleanroom Technology is collaborating with Nyxoah to develop the cleanroom, emphasizing innovation and local expertise in Belgium [3][9] Group 3: Company Overview - Nyxoah specializes in developing innovative solutions for Obstructive Sleep Apnea (OSA), with its lead product being the Genio system, a battery-free neurostimulation therapy [4][5] - The Genio system received its European CE Mark in 2019 and has expanded its therapeutic indications following successful studies [5]

PresentationGood morning, everyone, and welcome to the 44th Annual JPMorgan Healthcare Conference. My name is Varun, and it is my pleasure to invite on stage today Nyxoah, represented by their CEO, Olivier Taelman. Please put your hands together for Olivier.Olivier TaelmanCEO & Executive Director Thank you. Let me start by thanking JPMorgan for the invitation. My name is Olivier Taelman. I am the CEO of Nyxoah. Nyxoah, a medtech company offering an innovative solution by neurostimulation to help patients su ...

Nyxoah FY Conference Summary Company Overview - **Company**: Nyxoah (Ticker: NYXH) - **Industry**: Medtech, specifically focused on neurostimulation solutions for obstructive sleep apnea (OSA) - **Recent Milestone**: Obtained FDA approval in August 2025, actively launching products in the U.S. market [2][30] Market Opportunity - **Addressable Market**: Approximately 450,000-500,000 eligible patients in the U.S. for Genio technology, representing a market opportunity of around $10 billion [3] - **Market Penetration**: Currently, only 8% of the eligible patient population receives therapy, indicating a largely underpenetrated market [3] Product and Technology - **Genio Technology**: A differentiated, patient-first neurostimulation device with a unique bilateral mode of action [3][10] - **Clinical Evidence**: Robust clinical data from the DREAM study, showing efficacy in reducing Apnea-Hypopnea Index (AHI) and oxygen desaturation index [18] - **Patient Compliance**: Recorded over 87% compliance and 92% patient satisfaction [15] Treatment Landscape - **Current Treatment Options**: - CPAP (Continuous Positive Airway Pressure) is the gold standard but has a high quit rate (50% annually) [7][8] - Mandibular advancement devices have low predictability and high out-of-pocket costs [7] - Traditional surgery is invasive with a low success rate (30%-60%) [9] - Unilateral hypoglossal nerve stimulation has limitations due to battery implantation [10] Clinical Outcomes - **Efficacy Results**: - Median AHI reduction of over 70% after 12 months [20] - 82% of patients had AHI below 15, equating their morbidity risk to non-OSA individuals [20] - **Safety Profile**: Serious adverse event rate of 8.7%, lower than the average for neuromodulation solutions [18][19] Commercial Strategy - **Market Entry**: Successfully captured 25% market share in Germany within 24 months without direct-to-consumer marketing [21] - **U.S. Market Focus**: Targeting high-volume ENT surgeons and collaborating with sleep physicians for patient referrals [22][23] - **Reimbursement Strategy**: Established CPT code 64568, achieving 100% acceptance of pre-authorization files from major payers [25][36] Future Outlook - **Expansion Plans**: Focus on U.S. market while selectively expanding in Europe and UAE [40] - **Clinical Studies**: Ongoing trials for Complete Concentric Collapse (CCC) patients, with results expected in June 2026 [27][37] - **Technological Advancements**: Plans to enhance the wearable component and explore additional nerve stimulation options [38][39] Key Takeaways - Nyxoah is positioned to disrupt the OSA treatment market with its innovative Genio technology, backed by strong clinical evidence and a clear commercial strategy - The company is focused on expanding its market presence in the U.S. while maintaining a commitment to patient-first technology and improving treatment outcomes [28][29]

Group 1: Market Movements - Several biotech and healthcare companies experienced notable gains in after-hours trading, driven by earnings updates, guidance announcements, and broader investor sentiment [1] - FibroBiologics, Inc. (FBLG) led with a 7.68% increase, closing at $0.41, suggesting speculative interest or technical momentum [1] - Nyxoah SA (NYXH) advanced 3.94% to $5.28 after reporting preliminary results for Q4 and full year 2025, along with revenue guidance for Q1 2026 [2] - Fortress Biotech, Inc. (FBIO) climbed 6.90% to $4.49, continuing a trend of volatility despite no new news [2] - Revvity, Inc. (RVTY) gained 4.92% to close at $109.00, with investors likely reacting to a previous collaboration announcement with Eli Lilly [3] - Option Care Health, Inc. (OPCH) rose 3.28% to $33.11 after releasing preliminary unaudited financial results for Q4 and full year 2025, along with guidance for 2026 [4] - Actinium Pharmaceuticals, Inc. (ATNM) added 3.02% to close at $1.34, reflecting investor activity in the broader biotech sector [4] - Design Therapeutics, Inc. (DSGN) gained 1.97% to $9.30, indicating continued interest despite no specific news [5] Group 2: Company-Specific Developments - FibroBiologics, Inc. (FBLG) showed a significant rise without any company-specific news, indicating potential speculative interest [1] - Nyxoah SA (NYXH) provided revenue guidance for Q1 2026, which bolstered investor confidence in its growth trajectory [2] - Revvity, Inc. (RVTY) is expanding access to predictive models through a collaboration with Eli Lilly, aimed at accelerating AI-enabled drug discovery [3] - Option Care Health, Inc. (OPCH) released preliminary financial results and guidance, contributing to its positive after-hours reaction [4]

INSIDE INFORMATIONREGULATED INFORMATION Nyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2025 and Provides Revenue Guidance for the First Quarter of 2026 Strong Start in First Full Quarter of U.S. Commercialization Mont-Saint-Guibert, Belgium – January 12, 2026, 10:05 pm CET / 4:05 pm 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 neu ...

Core Viewpoint - Nyxoah SA received a transparency notification from BNP Paribas Asset Management, indicating that BNP Paribas Asset Management Europe SAS holds 1,409,791 voting rights, which is 3.28% of the total voting rights as of December 31, 2025 [2][3]. Group 1: Notification Details - The notification was received on January 8, 2026, and it indicates that BNP Paribas Asset Management Europe SAS holds 1,409,791 voting rights, representing 3.28% of the total voting rights of 43,026,460 [3][5]. - The threshold crossed for this notification was 3%, with the relevant date being December 31, 2025 [5][6]. - The total number of voting rights held by BNP Paribas Asset Management Europe SAS includes 696,562 linked to securities and 1,409,791 total voting rights, with no unlinked securities [4][6]. Group 2: Ownership Structure - BNP Paribas Asset Management Europe SAS is a subsidiary of BNP Paribas Asset Management Holding, which is controlled by BNP Paribas SA [6]. - The notification is a result of the merger between BNP Paribas Asset Management Europe SAS and AXA Investment Managers SA on December 31, 2025, leading to the crossing of the 3% threshold [6].

Nyxoah to Present at the 44th Annual J.P. Morgan Healthcare Conference Mont-Saint-Guibert, Belgium – December 29, 2025, 10:05pm CET / 4:05pm 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 that the management team will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, Jan. 15, 2026. The ...

Core Viewpoint - Nyxoah SA has successfully issued the first tranche of convertible bonds amounting to €22.5 million as part of a larger financing plan of up to €45 million, aimed at supporting its operations and commercialization efforts in treating Obstructive Sleep Apnea (OSA) [1][2]. Group 1: Convertible Bonds Issuance - The first tranche of convertible bonds was issued for a nominal amount of €22.5 million, consisting of 225 bonds with a nominal value of €100,000 each, fully subscribed by Heights Capital Management (HCM) [2]. - A subscription fee of €1.8 million, equivalent to 8.0% of the principal amount, was paid to HCM, satisfied by set-off against the subscription price [2]. - The bonds carry an interest rate of 6.5% per annum and have a three-year maturity with quarterly amortization payments starting February 18, 2026 [3]. Group 2: Amortization and Conversion Rights - HCM has the right to bring forward the payment of up to two amortized payment amounts between scheduled amortization payment dates [4]. - HCM can convert the outstanding principal or any amortized payment amount at any time during the bond's term, with an initial conversion price set at €5.00 [5]. - Payments of amortized amounts can be made in cash or through the issuance of new ordinary shares, with the issue price determined by specific conditions [6]. Group 3: Future Tranche and Conditions - The company has the option to issue a second tranche of convertible bonds for an additional €22.5 million, contingent upon certain conditions being met between July 18, 2026, and August 18, 2026 [8]. - As of December 16, 2025, certain conditions precedent for the second tranche were not met, including daily traded values and market capitalization thresholds [10]. - The second tranche will be issued on similar terms as the first tranche, with the conversion price based on the lowest VWAP of the shares on the closing date [11]. Group 4: Cash Runway and Use of Proceeds - The issuance of the first tranche and the closing of capital increases will extend the company's cash runway into the third quarter of 2026, potentially extending to the first quarter of 2027 if the second tranche is issued [12]. - Net proceeds from the first tranche will be utilized for commercialization activities in the U.S., clinical data gathering, research and development, and general corporate purposes [13].

Core Insights - Nyxoah has announced the commercial launch of its Genio® system in the Netherlands, with successful implants performed at OLVG West and Zuyderland hospitals [1][2] - The Genio system is designed as a breakthrough therapy for Obstructive Sleep Apnea (OSA), providing an alternative for patients who cannot tolerate CPAP [2][3] - The launch reflects Nyxoah's ongoing expansion in Europe and the growing adoption of its bilateral, externally powered Genio therapy [2] Company Overview - Nyxoah is a medical technology company focused on innovative solutions for treating OSA, with its lead product being the Genio system, which is leadless and battery-free [3] - The company aims to improve the quality of life for OSA patients, who face increased mortality risk and cardiovascular issues [3] Product Features - The Genio system stimulates both branches of the nerve, is MRI-compatible, and can be upgraded via an external activation chip, making it a promising long-term solution [2] - The absence of an implanted battery and reliable performance in the supine position are highlighted as significant advantages of the Genio system [2] Regulatory Milestones - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [4] - Nyxoah has also completed IPOs on Euronext Brussels and NASDAQ, and received FDA approval for a subset of adult patients with moderate to severe OSA in August 2025 [4]

Nyxoah FY Conference Summary Company Overview - **Company**: Nyxoah (NasdaqGM:NYXH) - **Industry**: Medical Technology, specifically focused on hypoglossal nerve stimulation for obstructive sleep apnea (OSA) Key Points U.S. Launch Status - Nyxoah received FDA approval on August 8, 2025, and began its U.S. launch on August 11, 2025 - As of early December, the company has focused on high-volume hypoglossal nerve stimulation accounts, covering approximately 125 out of 400 targeted accounts, which represent about 75% of U.S. revenue volume [6][10] - The company has trained 128 surgeons and submitted 108 pre-market approval (PMA) submissions, with a 100% approval rate for pre-authorizations from private payers and CMS [9][10] Sales Force Expansion - Nyxoah has added 15 territory managers, increasing the total to 40, which will allow the company to target an additional 75 high-volume implant accounts [10][21] - The commercial organization now consists of 50 people, including market access personnel and field engineers [19][20] Financial Guidance and Market Share - For Q4 2025, Nyxoah provided revenue guidance of EUR 3.4 million to EUR 3.6 million [23] - The U.S. H&S market is projected to be around $1 billion in 2026, with Nyxoah aiming for a market share significantly higher than the 3% initially suggested, potentially reaching 15%-25% in focused accounts [24][25] Patient Outcomes and Data Collection - Early feedback from surgeons on patient outcomes post-implantation has been positive, with successful airway openings observed [27][29] - Nyxoah is required to conduct a post-PMA study to follow up on patients, which will also help in developing health economic data [29] Reimbursement Updates - A significant reimbursement change effective January 1, 2026, will increase facility fees for CPT code 64568 by 40%-50%, which is expected to encourage more hospitals to adopt hypoglossal nerve stimulation [30][31] - Nyxoah plans to observe the market dynamics and will not deviate from its focused launch strategy despite the reimbursement changes [32] Long-term Reimbursement Strategy - Nyxoah anticipates the establishment of a dedicated H&S code for reimbursement, moving away from a monopoly of existing technologies [37] GLP-1 Impact - The introduction of GLP-1 medications is seen as a positive development, potentially expanding the patient base eligible for treatment due to improved BMI and AHI metrics [38][39] Future Studies and Innovations - Nyxoah is preparing for a study on Complete Concentric Collapse (CCC) with data expected in August 2026 and potential U.S. commercialization in late 2026 or early 2027 [41][45] - The company is also exploring dual stimulation modalities involving Ansa cervicalis, with first human trials expected within six months [48][49] Financial Performance and Projections - Gross margins are expected to improve from the low 60s to the low 80s by 2027 due to new product innovations and increased volume [52] - Operating expenses will rise as the sales force expands, with a focus on maintaining R&D investment [54] Financing and Cash Runway - Recent financing efforts have provided sufficient capital to support U.S. commercialization through early 2027, allowing flexibility for future funding decisions [55][56] Closing Remarks - Nyxoah emphasizes its commitment to providing options for OSA patients and its enthusiasm for the future of its technology [58]