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01/11 13:58
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
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.
Revenue EUR 2 million in Q3 2025 compared to EUR 1.3 million in Q3 2024, an increase of 56%. This growth was driven by the company's commercial investments in the U.S. following the FDA approval of Genio.
Gross Margin 60.5% in Q3 2025 compared to 62% in Q3 2024, a slight decrease. This was due to the acceleration in commercial investments in the U.S.
Operating Loss EUR 24.4 million in Q3 2025 versus EUR 15 million in Q3 2024. The increase was driven by the acceleration in the company's commercial investments in the U.S. in preparation for the post-FDA commercial launch.
Cash Position EUR 22.5 million as of September 30, 2025, compared to EUR 43 million as of June 30, 2025. The decrease reflects the company's increased spending on commercialization efforts.
FDA approval and U.S. launch of Genio: Genio received FDA approval on August 8, 2025, and its U.S. launch has generated strong enthusiasm among ENT and sleep communities. The first commercial Genio implant in the U.S. generated $231,000 in revenue during Q3 2025.
Genio's unique features: The Genio system offers a bilateral, patient-centric design, providing a differentiated solution for Obstructive Sleep Apnea (OSA). It achieves symmetric tongue protrusion with bilateral stimulation and has an efficient procedure time of up to 60 minutes.
Future innovation: Nyxoah plans to integrate AI and self-learning capabilities into the next generation of Genio, aiming to create a therapy that adapts and evolves over time.
U.S. market expansion: Nyxoah is focusing on the top 125 high-volume hypoglossal nerve sites in the U.S., representing 75%-80% of the total HGNS volume. 111 surgeons have been trained, 102 value analysis committee submissions completed, and 35 approvals received. Reimbursement has been secured with Medicare and 10 private payers, including UnitedHealthcare and Blue Cross Blue Shield.
International market expansion: Nyxoah is driving deeper penetration in Germany, the UK, and the Middle East, where it holds exclusive status as the only available HGNS solution.
Reimbursement progress: Nyxoah achieved 100% approval on prior authorization submissions through its Genio Access Program, which includes support for real-time tracking and communication.
Revenue growth: Q3 2025 revenue increased by 56% year-over-year to EUR 2 million, driven by U.S. commercialization efforts.
Financial position: Nyxoah secured up to $77 million in capital, including $25 million from a private equity placement and $52 million from a convertible bond, extending its cash runway into Q1 2027.
Strategic focus on chronic disease management: Nyxoah emphasizes managing OSA as a chronic condition, integrating patient feedback and multidisciplinary care pathways.
Commercial investments: The company accelerated U.S. commercial investments post-FDA approval, focusing on training, account activation, and payer coverage.
Early commercialization challenges: Navigating the critical steps of early commercialization, including training physicians, obtaining value analysis committee approvals, and securing coverage from major public and private payers, poses risks to the company's ability to scale effectively.
Reimbursement and payer coverage: While progress has been made, the company is still in the process of engaging with additional commercial payers to secure broader coverage. Delays or denials in reimbursement approvals could hinder patient access and revenue growth.
Financial sustainability: The company reported a significant operating loss of EUR 24.4 million in Q3 2025, driven by increased commercial investments. Additionally, the cash position decreased from EUR 43 million to EUR 22.5 million within three months, raising concerns about financial sustainability despite securing additional capital.
Market competition: The company is entering a competitive market with its Genio system. While initial feedback is positive, maintaining differentiation and capturing market share against established players remains a challenge.
Regulatory and administrative barriers: Although some progress has been made in streamlining administrative processes, regulatory and administrative barriers, such as obtaining CPT code inclusions and prior authorizations, could slow down adoption and patient access.
Global expansion risks: Efforts to expand into markets like Germany, the UK, and the Middle East come with risks related to market penetration, regulatory compliance, and operational execution in diverse geographies.
U.S. Commercial Expansion: Nyxoah plans to continue expanding its U.S. commercial organization by adding territory managers to deepen coverage of high-volume implanting centers. Training programs for surgeons are scheduled through year-end, with a strong pipeline of surgeons requesting implant slots.
International Market Penetration: The company is focused on driving deeper penetration in Germany, the United Kingdom, and the Middle East, where it holds exclusive status as the only available HGNS solution. Selective expansion into additional geographies with strong demand for differentiated technology is also planned.
Revenue Guidance for Q4 2025: Nyxoah expects global revenue to be between EUR 3.4 million and EUR 3.6 million for the fourth quarter of 2025.
Next-Generation Genio Development: Nyxoah is integrating AI and self-learning capabilities into the next generation of its Genio system. The new system aims to adapt, evolve, and become more personalized over time, creating an ecosystem that empowers patients, physicians, and healthcare payers.
Reimbursement Progress: The company has secured reimbursement with Medicare and 10 private payers, including UnitedHealthcare, Blue Cross Blue Shield, and Cigna. It expects continued progress on commercial payer policy decisions in the coming quarters.
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%.
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