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Nyxoah SA (NYXH) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference Transcript
Seeking Alpha· 2025-09-10 06:50
Question-and-Answer SessionYes, absolutely. So maybe to kick it off, for those in the audience unfamiliar with Nyxoah, could you please provide a brief overview of how Nyxoah is changing the obstructive sleep apnea landscape?Olivier TaelmanCEO & Executive Director Yes. No, no, definitely. So with Nyxoah, we are offering an innovative next-generation neuromodulation solution, more specific hypoglossal nerve stimulation to treat moderate-to-severe OSA patients. I do think we can say we have a totally differen ...
Nyxoah (NasdaqGM:NYXH) FY Conference Transcript
2025-09-09 22:37
Nyxoah Conference Call Summary Company Overview - **Company**: Nyxoah - **Industry**: Medical Technology, specifically focused on obstructive sleep apnea (OSA) treatment Key Points and Arguments Innovative Technology - Nyxoah offers a next-generation neuromodulation solution for moderate to severe OSA patients, utilizing hypoglossal nerve stimulation with bilateral stimulation and single-incision implants [3][4] - The system is designed to be fully MRI compatible and does not require an implantable battery, eliminating the need for re-surgery when the battery is depleted or when software upgrades are needed [3][4] Clinical Evidence and DREAM Study - The DREAM pivotal study aimed to reduce the apnea-hypopnea index (AHI) by at least 50% and bring the overall number of events below 20 [5][6] - The study reported a severe obstructive event percentage of 8.7%, significantly lower than the competition's nearly 20% [6] - Median reduction in AHI was reported at 70%, with 82% of participants achieving an AHI below 15, which is a critical threshold for treatment eligibility [8][9] FDA Approval and Market Entry - Nyxoah received FDA approval on August 8, allowing the company to launch its product in the U.S. market [10][11] - The approval includes specific indications for patients with extreme difficult airway openings, which are contraindicated for current AGNS technology [10][11] Commercial Strategy - The company has a two-pronged launch strategy targeting both sleep physicians and ENT surgeons, emphasizing the role of sleep physicians in patient management [15][17] - Nyxoah has already trained over 100 physicians and aims to expand its commercial team to increase market penetration [13][36] Market Penetration and Competition - Nyxoah aims to capture high-volume implanting sites, with a goal of reaching 400 sites that represent 80% of the total volume in the U.S. [18][20] - The company has successfully captured a 25% market share in Germany within two years and aims to replicate this success in the U.S. [20][21] Reimbursement Strategy - Nyxoah is actively working with payers to ensure reimbursement for its technology, leveraging existing CPT codes and engaging with major commercial payers [22][23] - The company has received positive feedback from Medicare regarding coding acceptance, which is crucial for scaling up operations [23][24] Future Innovations and R&D - Nyxoah is focused on continuous innovation, including developing a more intelligent implantable device and a wearable component that provides real-time feedback to patients [44][45] - The company is exploring the potential for a pillow charging concept for its devices, aiming for a seamless user experience [45][49] Patient Profile and Market Trends - The ideal patient profile for Nyxoah's treatment includes individuals aged around 53-54 who are health-conscious and motivated to maintain a healthy lifestyle [29][30] - The emergence of GLP-1 therapeutics may expand the patient pool by enabling weight loss in individuals with higher BMIs, which could lead to increased demand for Nyxoah's technology [33][35] Access Trial and Clinical Validation - The ACCESS trial aims to validate the effectiveness of Nyxoah's technology for patients with complete concentric collapse (CCC), with a submission for label expansion expected by Q1 2027 [50][52] Differentiation and Manufacturing - Nyxoah emphasizes the differentiation of its technology through bilateral stimulation and the scalability of its platform, which is designed to benefit patients significantly [54][55] Additional Important Insights - The company has made strategic decisions to manufacture in the U.S. for the U.S. market, which is seen as a beneficial move given current market dynamics [54]
Nyxoah (NYXH) 2025 Conference Transcript
2025-09-04 16:30
Summary of Nyxoah (NYXH) 2025 Conference Call Company Overview - **Company Name**: Nyxoah - **Industry**: Medical Technology (MedTech) - **Focus**: Innovative solutions for treating obstructive sleep apnea (OSA) patients - **Key Product**: Genio solution, which received FDA approval on August 8, 2025, and launched in the U.S. on August 11, 2025 [6][20] Market Insights - **Obstructive Sleep Apnea Market**: - Significant market with millions of patients in the U.S. suffering from moderate to severe OSA [5][7] - The market is described as having "blockbuster potential" due to the large number of eligible patients for treatment [9] - **Current Treatment Landscape**: - CPAP (Continuous Positive Airway Pressure) is the gold standard but has a compliance issue, with nearly 50% of patients discontinuing use after 2-3 years [10][11] - Genio aims to fill the gap for patients who cannot tolerate CPAP [19] Product Differentiation - **Genio Device Mechanism**: - Utilizes bilateral stimulation to maintain airway openness during sleep by contracting the genioglossus muscle [12][14] - No implantable battery, making it more patient-friendly and MRI compatible [14][15] - Software updates can be performed without surgery, enhancing user experience [15] Commercial Strategy - **U.S. Market Entry**: - Focused launch strategy targeting high-volume centers and establishing relationships with key customers [20][26] - Initial revenue expected to ramp up in 2026, with foundational work being done in 2025 [27][28] - **Operational Expenditures**: - R&D spending expected to increase in the mid-single digits percentage-wise compared to the previous year [30] - SG&A expenses projected to rise by 66-75% due to investments in the U.S. commercial organization [31] Financial Outlook - **Current Cash Position**: - €43 million in cash as of June, with a reduced cash burn from €23 million to €20 million in Q2 [38][39] - Sufficient cash to sustain operations into 2026, with plans to evaluate capital-raising options [40] - **Revenue Breakeven Point**: - Estimated to be around $200 million, which is lower than competitors, allowing for a more targeted commercialization approach [41] Future Developments - **Data Collection and Registry**: - Plans to establish a registry to collect patient data and health economic data to support payer negotiations [32][34] - **Future Product Iterations**: - Development of a smart implant capable of automatic adjustments and a closed-loop system for enhanced patient experience [35][36] Key Takeaways - Nyxoah is positioned to capitalize on a significant market opportunity in the OSA space with its innovative Genio solution - The company is focused on building a strong commercial presence in the U.S. while managing operational expenditures effectively - Future growth will depend on successful market penetration, patient compliance, and ongoing product development initiatives [6][20][27]
Nyxoah Announces Upcoming Investor Events
Globenewswire· 2025-09-02 20:30
Nyxoah Announces Upcoming Investor Events Mont-Saint-Guibert, Belgium – September 2, 2025, 10:30pm CET / 4:30PM 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), today announced that the Company will participate in the following events during September: 2025 Wells Fargo Healthcare ConferenceSeptember 3rd – Boston, MA Cantor Global Healthcare Conference 2025 September 4 ...
Nyxoah: High-Risk High-Reward Medtech To Own
Seeking Alpha· 2025-08-20 12:00
Group 1 - The company Nyxoah has received FDA approval for its innovative Genio product, marking a significant milestone in its development [1] - Nyxoah has published its second-quarter earnings, which are crucial for assessing its financial health and growth potential [1] - The analysis emphasizes a focus on undervalued companies with strong fundamentals and good cash flows, highlighting the potential for substantial returns in sectors like Oil & Gas and consumer goods [1] Group 2 - The analyst expresses a long-term value investing approach, while also engaging in deal arbitrage opportunities, indicating a flexible investment strategy [1] - There is a clear preference for companies that are well understood, avoiding high-tech and certain consumer goods sectors, which may indicate a risk-averse investment philosophy [1] - The analyst aims to connect with like-minded investors through Seeking Alpha, fostering a community focused on informed decision-making and superior returns [1]
Nyxoah(NYXH) - 2025 Q2 - Earnings Call Transcript
2025-08-18 21:30
Financial Data and Key Metrics Changes - Revenue for Q2 2025 was €1,300,000, an increase of 73.8% compared to €800,000 in Q2 2024 [16] - Gross margin for Q2 2025 was 63.4%, essentially flat compared to the previous year [16] - Total operating loss for Q2 2025 was $19,900,000, up from $13,300,000 in Q2 2024, driven by increased commercial investments in the U.S. [16][17] - Cash position as of June 30, 2025, was €43,000,000, down from €63,000,000 at March 31, 2025 [17] Business Line Data and Key Metrics Changes - The GENIOR system received FDA PMA approval, marking a significant advancement in treatment options for obstructive sleep apnea (OSA) patients in the U.S. [5][6] - The device demonstrated a compliance rate of 85.9% and a patient satisfaction score of 90% [10] Market Data and Key Metrics Changes - The U.S. market for OSA treatment is concentrated, with approximately 1,400 implanting accounts, of which 350 to 400 are high-volume accounts representing 75% to 80% of total revenue [34][35] - The company has identified demand from patients hesitant about receiving implanted batteries, which the GENIOR system addresses with its unique design [13] Company Strategy and Development Direction - The company has a two-pronged launch strategy targeting high-volume hypoglossal neurostimulation implanting centers and developing strong referral networks with physicians managing large populations of OSA patients [11][36] - The company aims to differentiate itself through its unique technology benefits and patient focus, particularly in the context of competition with GLP-1 treatments [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the success of the U.S. launch, citing enthusiastic responses from physicians and patients [19] - The remainder of 2025 is expected to be transformative as the company establishes GENIOR in the U.S. market [20] Other Important Information - The company has stopped enrollment in the ACCESS study, believing that the current number of patients enrolled is sufficient for meaningful conclusions [8] - A patent lawsuit initiated by Inspire Medical against the company will not impact the U.S. commercial launch [15] Q&A Session Summary Question: Year-end 2025 metrics and indicators to focus on - Management will track the number of trained physicians and value analysis committee applications as leading indicators [22][24] Question: Leveraging the differentiated label - The company plans to capitalize on the label differentiation by emphasizing the ability to treat positional OSA and the lack of contraindication for complete concentric collapse (CCC) patients [26][28] Question: Commercial strategy and targeted accounts - The sales team will focus on high-volume implanting accounts, which represent a significant portion of revenue [34][35] Question: Reimbursement strategy and payer onboarding - The company expects to see pre-authorization decisions coming in this year, while coverage decisions may be more of a 2026 story [41][42] Question: Access trial and CCC patient treatment - The company will not promote off-label indications but is optimistic about treating CCC patients once the ACCESS trial data is available [69][71] Question: Pricing strategy - The company intends to follow the same pricing strategy as competitors, pricing at approximately $25,000 [74] Question: Initial surgeon engagement and market share - Surgeons must present five defined patient cases before being trained, and the company does not set specific market share expectations at this stage [77][79]
Nyxoah(NYXH) - 2025 Q2 - Quarterly Report
2025-08-18 20:45
Table of Contents Exhibit 99.2 INTERIM FINANCIAL REPORT FIRST HALF 2025 TABLE OF CONTENTS | Interim financial report | 2 | | --- | --- | | 1. BUSINESS UPDATE | 2 | | 2. FINANCIAL HIGHLIGHTS | 4 | | 3. 2025 OUTLOOK | 4 | | 4. RISK FACTORS | 5 | | 5. FORWARD-LOOKING STATEMENTS | 5 | | Unaudited condensed consolidated interim financial information as at and for the six months ended June 30, 2025 – | | | Interim consolidated statement of financial position | 6 | | Unaudited condensed consolidated interim financ ...
Nyxoah Reports Second Quarter Financial and Operating Results
GlobeNewswire News Room· 2025-08-18 20:10
Core Insights - Nyxoah has received FDA approval for its Genio system, marking a significant milestone as it becomes the first and only bilateral hypoglossal neurostimulation therapy approved in the U.S. for Obstructive Sleep Apnea (OSA) [4][5][8] - The company has initiated the commercial launch of the Genio system in the U.S., supported by positive data from the DREAM pivotal trial, which demonstrated significant efficacy in reducing apnea-hypopnea index (AHI) [4][6][8] Financial Performance - Revenue for Q2 2025 was €1.34 million, a 74% increase from €0.77 million in Q2 2024 [8][12] - Gross profit for Q2 2025 was €0.85 million, with a gross margin of 63.4%, compared to a gross profit of €0.49 million and a margin of 63.6% in Q2 2024 [7][13] - Operating loss for Q2 2025 was €19.85 million, up from €13.33 million in Q2 2024, primarily due to increased selling, general, and administrative expenses related to the commercialization of the Genio system [7][16][17] Research and Development - R&D expenses for Q2 2025 were €10.06 million, compared to €7.47 million in Q2 2024, reflecting increased R&D activities [14] - Selling, general, and administrative expenses rose to €10.67 million in Q2 2025 from €6.38 million in Q2 2024, driven by costs associated with the commercialization efforts for the Genio system [15] Cash Position - As of June 30, 2025, the company had cash, cash equivalents, and financial assets totaling €43.0 million, down from €63.0 million at the end of Q1 2025 [8][18] Market Position - The Genio system is positioned as a differentiated solution for OSA patients, particularly those underserved by existing therapies, with a focus on providing a leadless and battery-free treatment option [4][22]
Nyxoah Secures FDA Clearance for Genio System to Treat Sleep Apnea
ZACKS· 2025-08-15 15:11
Company Overview - Nyxoah (NYXH) received FDA approval for its Genio system, an innovative therapy for moderate to severe Obstructive Sleep Apnea (OSA) featuring a leadless, battery-free design powered by an upgradable wearable [1][8] - The Genio system utilizes a unique bilateral nerve stimulation approach, now launching in the U.S. market [1][3] Clinical Trial Results - The FDA approval was supported by the DREAM pivotal trial, which achieved a 63.5% apnea-hypopnea index (AHI) responder rate and a 71.3% Oxygen Desaturation Index (ODI) responder rate, with a median AHI reduction of 70.8% [4] - Notably, 82% of participants saw their AHI drop below 15, demonstrating Genio's efficacy across all sleeping positions [4][5] Product Features - Genio's design is MRI compatible (1.5T and 3T), making it more convenient and less invasive for patients [3] - The system is powered and controlled by a wearable component, which is fully upgradable, allowing for technology updates without additional surgeries or battery replacements [3][5] Market Prospects - The global sleep apnea devices market was estimated at $4.5 billion in 2023 and is projected to reach $6.9 billion by 2030, with a CAGR of 6.2% from 2024 to 2030 [6] - Key growth drivers include a growing geriatric population, a significant patient pool with sleep apnea, and the development of advanced devices [6] Competitive Landscape - Nyxoah competes with several innovative players in the sleep apnea treatment market, including Inspire Medical Systems, ResMed, and LivaNova, all of which are developing advanced therapies and devices [7][10][11] - Inspire Medical Systems launched its Inspire V neurostimulation system, which features a 20% reduction in implant time and Bluetooth-enabled connectivity [7][9] - ResMed introduced its AirSense 11 CPAP device with advanced capabilities to enhance patient adherence and clinician access [10] - LivaNova reported a 65% responder rate in its OSPREY trial for its aura6000 proximal hypoglossal nerve stimulator, indicating sustained efficacy [11]
Nyxoah Announces Preliminary Results for the Second Quarter of 2025
Globenewswire· 2025-08-11 05:00
Core Viewpoint - Nyxoah has reported preliminary financial results for Q2 2025, indicating significant growth and successful commercial proof of concept in Germany, with plans to expand into the U.S. market following FDA approval of its Genio system [1][3]. Financial Results - Revenue for Q2 2025 is anticipated to be approximately €1.3 million, representing a 73% increase compared to Q2 2024 [4]. - Operating expenses for Q2 2025 are expected to be around €20.7 million, a 50% increase from Q2 2024 [4]. - Cash, cash equivalents, and financial assets are projected to be approximately €43.0 million as of June 30, 2025 [4]. Business Updates - The Genio system has received FDA approval for a subset of adult patients with moderate to severe Obstructive Sleep Apnea (OSA), specifically those with an Apnea-Hypopnea Index (AHI) between 15 and 65 [4][6]. - The company plans to close patient enrollment in its ACCCESS clinical trial, which aims to assess the safety and efficacy of Genio therapy for patients suffering from Complete Concentric Collapse (CCC) [4]. - Nyxoah has reorganized its global R&D function, transitioning ongoing activities from Israel to the U.S. and Belgium [4]. Legal Matters - Inspire Medical Systems, Inc. has filed a lawsuit against Nyxoah in the U.S. for alleged patent infringement, and the company intends to vigorously defend itself [4].