Loading...
01/11 13:57
Loading...
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call presents a mixed picture. While there is optimism about the Genio launch and strategic plans, the company's cash position has decreased significantly, and there are uncertainties in key metrics and timelines. The Q&A reveals some positive differentiation factors but also highlights unclear responses from management on critical metrics, which may raise investor concerns. Overall, the sentiment is balanced, leading to a neutral stock price prediction.
Revenue EUR 1.3 million in Q2 2025 compared to EUR 800,000 in Q2 2024, an increase of 73.8%. The increase was driven by the company's commercial investments in the U.S. in preparation for post-FDA commercial launch.
Gross Margin 63.4% in Q2 2025, essentially flat compared to Q2 2024.
Total Operating Loss EUR 19.9 million in Q2 2025 versus EUR 13.3 million in Q2 2024. The increase was driven by the acceleration in the company's commercial investments in the U.S. in preparation for post-FDA commercial launch.
Cash Position EUR 43 million at June 30, 2025, compared to EUR 63 million at March 31, 2025. The decrease reflects the company's ongoing investments and operational expenses.
FDA PMA approval for Genio system: Nyxoah received FDA PMA approval for its Genio system in the U.S., marking it as the first and only bilateral HGNS approved for treating obstructive sleep apnea (OSA).
DREAM study publication: The DREAM study was published in the Journal of Clinical Sleep Medicine, highlighting high patient satisfaction (90%) and compliance (85.9%).
Unique product features: The Genio system is not contraindicated for patients with complete concentric collapse (CCC) and can treat positional OSA, validated by clinical outcomes.
U.S. market entry: Nyxoah officially entered the U.S. market with the Genio system, supported by a commercial team of over 50 professionals and a two-pronged launch strategy targeting high-volume centers and referral networks.
Reimbursement strategy: The company identified CPT code 64568 for reimbursement, aligning with competitors, and is working with CMS and commercial payors for favorable coverage decisions.
International market potential: The publication of the DREAM study is expected to facilitate access to new international markets.
Commercial investments: Operating loss increased due to accelerated U.S. commercial investments post-FDA approval.
Physician training: Over 100 U.S. physicians have been trained, with additional weekly sessions scheduled, indicating strong momentum.
Patient population strategy: Nyxoah strategically limited its patient population to those with a BMI below 32, leveraging GLP-1 data to expand eligibility.
Patent lawsuit: Nyxoah is defending against a patent lawsuit from Inspire Medical, which is not expected to impact the U.S. launch.
Regulatory and Clinical Risks: The safety and effectiveness of the Genio system for patients with complete concentric collapse (CCC) has not been established based on U.S.-specific clinical data. This poses a risk to expanding the patient population and achieving broader adoption.
Patent Litigation: Nyxoah is facing a patent lawsuit from Inspire Medical, which could lead to legal costs and potential disruptions, even though the company states it will not impact the U.S. commercial launch.
Financial Risks: The company reported an operating loss of EUR 19.9 million in Q2 2025, driven by increased commercial investments in the U.S. This raises concerns about financial sustainability, especially with a declining cash position from EUR 63 million to EUR 43 million within a quarter.
Market Competition: Nyxoah faces competitive pressures from established players like Inspire Medical, which could impact market share and pricing strategies.
Reimbursement and Payor Risks: While the company is working on reimbursement strategies, there is uncertainty around the acceptance of pre-authorization submissions and favorable coverage decisions by CMS and commercial payors.
Supply Chain and Operational Risks: The rapid U.S. launch and scaling operations may strain supply chain and operational capabilities, potentially impacting product availability and service quality.
U.S. Market Launch of Genio System: Nyxoah has received FDA PMA approval for its Genio system, marking the beginning of its U.S. market entry. The company has initiated a focused U.S. launch with a commercial team of over 50 professionals targeting high-volume hypoglossal neurostimulation implanting centers and developing referral networks with sleep physicians.
Reimbursement and CPT Code Utilization: Nyxoah has identified CPT code 64568 for reimbursement, which is recognized by commercial and government payors for the OSA indication. The company is working with the American Academy of Otolaryngology and participating in the FDA's Early Payor Feedback Program to secure favorable coverage decisions.
Physician Training and Market Momentum: Over 100 U.S. physicians have been trained on the Genio system, with additional weekly training sessions scheduled. Early market traction is evident, with physicians lining up patients for Genio implants within the first week of commercialization.
Impact of GLP-1 on HGNS Market: Nyxoah anticipates growth in the eligible patient population for Genio due to GLP-1's ability to reduce BMI levels, making more patients eligible for treatment. The company has strategically limited its patient population to those with a BMI below 32, where Genio's efficacy is proven.
Patent Lawsuit and Commercial Launch: Nyxoah is addressing a patent lawsuit initiated by Inspire Medical but asserts that this will not impact its U.S. commercial launch, which is generating significant enthusiasm.
Financial Outlook for 2025: The company expects the remainder of 2025 to be transformative as it establishes Genio in the U.S. market and advances its mission of improving sleep for patients worldwide.
The selected topic was not discussed during the call.
The earnings call highlights significant positives such as FDA approval and strong U.S. market entry, with a trained sales force and growing physician interest. Despite increased operating losses and a slight gross margin decline due to U.S. investments, optimistic guidance and strategic plans for expansion and reimbursement suggest positive momentum. The Q&A reinforced positive sentiment, with excitement over the Genio system's unique offering. However, the lack of detailed revenue breakdowns and increased cash burn are concerns. Overall, the strategic U.S. launch and promising guidance outweigh the negatives, suggesting a likely positive stock movement.
The earnings call presents a mixed picture. While there is optimism about the Genio launch and strategic plans, the company's cash position has decreased significantly, and there are uncertainties in key metrics and timelines. The Q&A reveals some positive differentiation factors but also highlights unclear responses from management on critical metrics, which may raise investor concerns. Overall, the sentiment is balanced, leading to a neutral stock price prediction.
Despite anticipation for FDA approval and growth projections, the earnings call reveals concerning factors. The decrease in revenue and increased operating loss, coupled with a significant drop in cash position, indicate financial strain. The lack of a share buyback program and potential regulatory and competitive risks further contribute to a negative outlook. Additionally, management's unclear responses in the Q&A section regarding FDA timelines and CCC labeling add uncertainty. Overall, these factors outweigh the positive aspects, leading to a predicted stock price movement of -2% to -8%.
All transcripts are sourced directly from the official live webcast or the company’s official investor relations website. We use the exact words spoken during the call with no paraphrasing of the core discussion.
Full verbatim transcripts are typically published within 4–12 hours after the call ends. Same-day availability is guaranteed for all S&P 500 and most mid-cap companies.
No material content is ever changed or summarized in the “Full Transcript” section. We only correct obvious spoken typos (e.g., “um”, “ah”, repeated 10 times”, or clear misspoken ticker symbols) and add speaker names/titles for readability. Every substantive sentence remains 100% as spoken.
When audio quality is poor or multiple speakers talk over each other, we mark the section instead of guessing. This ensures complete accuracy rather than introducing potential errors.
They are generated by a specialized financial-language model trained exclusively on 15+ years of earnings transcripts. The model extracts financial figures, guidance, and tone with 97%+ accuracy and is regularly validated against human analysts. The full raw transcript always remains available for verification.
