Nyxoah SA (NYXH) Q3 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
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.
Key Financial Performance
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.
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Operating Highlights
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.
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Risk or Challenges
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.
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Guidance & Outlook
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.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:What feedback are physicians and patients providing about choosing Genio over other options?
A:Physicians are excited about having the option to offer the Genio solution, which resonates strongly. The bilateral stimulation solution respects the anatomy of the hypoglossal nerve and allows treatment of patients with more complex airway obstructions.
Q:What is the current status of the sales force build-out?
A:The company is focusing on the top 400 implant accounts in the U.S., covering the first 125 with the current sales force. They plan to add up to 15 territory managers each quarter, covering an additional 75 implant sites per quarter, aiming for a total sales force of 85 people to cover all 400 sites.
Q:How many implants were done in the U.S. in Q3, and what was the U.S. revenue for Q3?
A:15 implants were done across 9 accounts by the end of October, generating EUR 231,000 in revenue by the end of September.
Q:What is the guidance for Q4 revenue, and will U.S. versus OUS revenue be broken out?
A:The guidance for Q4 revenue is EUR 3.4 million to EUR 3.6 million. The company will not break out U.S. versus international revenue at this stage, as they are still in the early phases of the U.S. account activation ramp.
Q:Did the company mention anything about the device becoming more proximal over time?
A:No, the CEO clarified that there are no changes in the positioning of the device. The next-generation product will integrate self-learning, making the device smarter and more autonomous, giving patients more control.
Q:What is the initial appeal of Genio implants, and how is it being slotted logistically in hospitals?
A:The technology appeals to both males and females, with an average patient age of 52-54 years. Patients value the implant-for-life concept, avoiding resurgery for battery depletion or software upgrades. Genio is differentiated from pacemaker platforms and is being slotted in high-volume accounts, breaking the monopoly of existing solutions.
Q:What KPIs will the company provide on a quarterly basis?
A:In the short term, the company will provide metrics such as the number of surgeons trained, accounts that have implanted, and VAC figures. Over time, they may drop the VAC metric as they become a more material revenue generator.
Q:Why did the number of implants decrease from September to October?
A:The decrease is due to the time required for preauthorization approvals and VAC committee approvals, which take about 4 weeks in total. Despite this, the company has achieved 9 active implant centers within 7 weeks post-approval.
Q:What was the biggest surprise for the CEO during the U.S. launch?
A:The CEO was positively surprised by the speed of surgeon training, VAC approvals, and preauthorization processes, allowing for faster-than-expected implants.
Q:What is the average selling price (ASP) of the implants, and how does the company expect U.S. revenue to grow in Q4?
A:The ASP is approximately $25,000. U.S. revenue is expected to grow from October to November and again from November to December, based on the number of cases planned for the remaining months of Q4.
Q:How will the U.S. rollout impact gross margins, and what is the long-term gross margin target?
A:Gross margins are currently in the low 60s, with a long-term target of 80%. Improvements will come from next-generation products, increased production volumes, and supply chain efficiencies, expected to materialize by late 2026 or early 2027.
Q:What is the status of reimbursement for Genio in the U.S., and what CPT code is being used?
A:The company uses CPT Code 64568, recognized by Medicare and commercial payers for HGNS therapy. The reimbursement process is progressing well, with preauthorization approvals taking about 2 weeks and payments being received within another 2 weeks.
Q:Review of Unclear Management Responses
A:Management avoided providing a direct answer when asked to break out U.S. versus OUS revenue for Q4, citing the early phase of the U.S. account activation ramp. Additionally, they did not provide specific details on the cadence of implants in November and December to meet Q4 guidance, only stating that U.S. revenue is expected to grow month-over-month.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
Access Program
Blue Cross
Blue Shield
CPT Code
Care Service
Cigna
Cross Blue
HCSC Blue
Health Care
Michigan
Nyxoah
Surgeons
UnitedHealthcare Blue
analysis committee
authorization
capital
clinician
closing
commercialization
hypoglossal nerve
indicator
payer UnitedHealthcare
policy
procedure
provider
surgeon feedback
territory manager
tranche
transaction
value analysis
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