Nyxoah SA (NYXH) Q4 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call reveals strong financial performance with a significant increase in revenue and gross margin, driven by U.S. market expansion. The company shows promising growth potential with strategic market penetration and next-gen product development. Despite operational challenges and a stable operating loss, future guidance indicates improvement. The Q&A highlights effective sales force expansion and financial stability until 2027. Overall, the positive revenue growth, strategic expansion plans, and optimistic guidance outweigh the concerns, suggesting a positive stock price movement over the next two weeks.
Key Financial Performance
Q4 2025 Revenue $4.5 million generated in Q4, driven by the U.S. launch. This translates into $720,000 annualized sales rep productivity during the first full quarter of launch.
Full Year 2025 Global Gross Revenue EUR 11 million, driven by strong Q4 U.S. launch momentum.
Q4 2025 Gross Revenue EUR 6.3 million before EUR 700,000 of revenue deferrals, resulting in net revenue of EUR 5.6 million compared to EUR 1.3 million in Q4 2024. This growth was driven by the U.S. commercial launch.
Full Year 2025 Net Revenue EUR 10 million compared to EUR 4.5 million in 2024, representing 122% year-over-year growth.
Q4 2025 Gross Margin 64%.
Full Year 2025 Gross Margin 63%.
Q4 2025 Operating Loss EUR 18.6 million compared to EUR 18.3 million in Q4 2024. Operating loss remained relatively stable year-over-year despite significant commercial investments.
Full Year 2025 Operating Loss EUR 83.5 million compared to EUR 58.8 million in 2024. The increase reflects the acceleration of U.S. commercialization activities.
Cash Position as of December 31, 2025 EUR 48 million, including cash, cash equivalents, and financial assets.
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Operating Highlights
FDA approval and launch of Genio: Received FDA approval for Genio on August 8, 2025, and actively launched the product in the U.S. market. Secured reimbursement across Medicare and commercial payers, resulting in first implants and revenue by September 2025.
Clinical efficacy of Genio: The DREAM pivotal study published in the Journal of Clinical Sleep Medicine demonstrated Genio's clinical efficacy in both supine and non-supine positions, differentiating it from competitors.
U.S. market entry: Entered the U.S. market, the largest HGNS market globally, with a focused launch strategy targeting 125 high-volume accounts out of 400. Trained 145 surgeons and achieved $4.5 million in Q4 revenue.
International market growth: Continued growth in selected international markets, including Germany, the UK, and the Middle East. Germany became the first profitable international market.
Sales force expansion: Hired and trained 25 U.S. sales reps in 2025, with plans to increase to 40 sales reps and 3 sales directors in 2026 to cover 200 top accounts.
Manufacturing footprint expansion: Expanding internal manufacturing capabilities to strengthen competitive position and improve gross margins.
Reimbursement strategy: Aligned Genio coverage with hypoglossal nerve stimulation therapies for Medicare and commercial payers. CMS established new interim C-codes for HGNS, ensuring no reimbursement difference between Genio and competitors.
Clinical data and label expansion: Anticipating 12-month ACCESS study data in 2026, potentially leading to U.S. label expansion in early 2027.
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Risk or Challenges
Regulatory and Reimbursement Challenges: The introduction of new CMS interim C-codes for hypoglossal nerve stimulation (HGNS) and the evolving procedural coding practices could create complexities in reimbursement processes. Although the company has aligned Genio coverage with Medicare and commercial payers, the maturation of coding practices and potential changes in reimbursement policies could impact financial outcomes.
Financial Losses: The company reported a total operating loss of EUR 83.5 million for 2025, a significant increase from EUR 58.8 million in 2024. This reflects the high costs associated with U.S. commercialization activities, which could strain financial resources if revenue growth does not meet expectations.
Market Competition: Nyxoah faces competitive pressures in the hypoglossal nerve stimulation market. While Genio offers unique features, maintaining differentiation and market share against established competitors will be critical to sustaining growth.
Operational Scaling Risks: The company is rapidly expanding its sales force and manufacturing footprint to support U.S. market growth. This rapid scaling could pose operational challenges, including maintaining quality, managing costs, and ensuring effective integration of new resources.
Economic and Market Uncertainties: The company’s reliance on the U.S. market for growth exposes it to economic and market fluctuations. Any downturn in healthcare spending or changes in market dynamics could adversely affect performance.
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Guidance & Outlook
Revenue Growth: U.S. net revenue is expected to grow 25% sequentially in both Q1 and Q2 of 2026, driven by surgeon training, additional value analysis committee approvals, and growing surgeon adoption. International revenue will follow typical seasonal patterns.
Sales Force Expansion: The company has increased its sales force by 15 sales reps and 3 sales directors in Q1 2026, bringing the total to 40 sales reps covering 200 of the top 400 hypoglossal nerve stimulation accounts.
Clinical Data and Label Expansion: The 12-month ACCESS study data on complete concentric collapse is expected in 2026, with a subsequent PMA supplement submission potentially leading to a U.S. label expansion in early 2027.
Manufacturing and Gross Margins: Nyxoah is expanding its internal manufacturing footprint in 2026 to strengthen its competitive position and improve gross margins.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:Can you provide an update on the 120 VAC submissions and the 57 accounts activated?
A:120 VAC submissions were made, with 57 approved as of December 31. The remaining submissions are expected to be approved during Q1. The company has increased its sales force from 25 to 40 reps, with each new rep expected to add 5 new accounts, potentially covering 200 out of 400 high-volume accounts by Q2.
Q:When will the ACCCESS study data be presented, and what is the timeline for PMA supplement submission and approval?
A:The 12-month data for the ACCCESS study will be available by the end of June, with analysis completed by the end of July. The PMA supplement submission will follow, with regulatory approval expected in Q1 2027. Data will be published and presented at a congress after journal acceptance, likely around July.
Q:What is the cash burn rate, and how does it impact the company's financial outlook?
A:The cash burn rate is approximately EUR 20 million per quarter, expected to decrease as U.S. revenue grows. The company raised capital through PIPE and convertible debt, providing sufficient funds to operate until Q1 2027.
Q:What are the company's plans regarding reimbursement coding and implant numbers?
A:The company is pursuing its own reimbursement coding, expected by early 2028. For now, they rely on interim C codes and existing CPT codes. Implant numbers are not disclosed, but revenue of $4.5 million in Q4 and an average system price of $25,000 provide an estimate. The company does not stockpile products on shelves and ensures implants align with patient needs.
Q:How does the company approach new site activations and manage inventory?
A:For new sites, the company provides implants based on pre-identified patients, typically 3 to 5, with 1 or 2 additional implants as backup. They do not stockpile inventory on shelves. High-volume centers are expected to sustain this dynamic as competitors enter the market.
Q:What are the key drivers for Genio adoption among surgeons and patients?
A:Surgeons value Genio's single-incision technique, bilateral stimulation, and quality of airway opening. Patients appreciate its minimally invasive design, upgradable software, and lack of need for resurgery. These factors differentiate Genio from competitors.
Q:What are the company's assumptions for new account additions and utilization in 2026?
A:The company aims to expand from 125 to 200 high-volume accounts by Q1 2026, supported by an increased sales force and ongoing surgeon training. VAC submission timelines vary by account, but the company expects gradual scaling.
Q:What is the guidance for gross margin and operating expenses in 2026?
A:Gross margin is expected to increase slightly in 2026 due to higher sales volume, with a significant jump in 2027 upon launching the next-generation disposable patch. R&D expenses will decrease sequentially in 2026, while SG&A expenses will rise due to the addition of 15 sales reps and 3 sales directors.
Q:Review of Unclear Management Responses
A:Management avoided providing specific implant numbers, citing a policy against disclosing them. They also did not provide detailed operating expense guidance for 2026, offering only general trends and drivers.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
Associate statement
CMS code
CMS surgeon
CPT physician
Claims CPT
Code payer
EUR deferral
EUR launch
EUR margin
Medicare payer
Nyxoah
Olivier
Surgeons
adoption
analysis committee
approval sale
commercialization
committee approval
competition
date
deferral patch
efficacy
feedback
goal
launch result
loss EUR
margin loss
market Germany
momentum
nerve stimulation
patch EUR
payer Medicare
physician fee
procedure
reimbursement Medicare
sale rep
value analysis
NYXH Transcript
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Positive5-12
The earnings call indicates strong revenue growth, sales force expansion, and expected improvement in gross margins. The Q&A section highlights clear reimbursement strategies and positive patient authorization trends. Despite some gross margin issues, resolution plans are in place. The company is managing cash burn effectively and anticipates sequential growth acceleration. Although there's competitive pressure from Inspire V, Genio's strategic focus on partnerships with sleep physicians is a positive aspect. Overall, the outlook is positive, with sequential growth and margin improvements expected, supporting a positive sentiment rating.
Nyxoah SA (NYXH) Q4 2025 Earnings Call Transcript
Positive3-19
The earnings call reveals strong financial performance with a significant increase in revenue and gross margin, driven by U.S. market expansion. The company shows promising growth potential with strategic market penetration and next-gen product development. Despite operational challenges and a stable operating loss, future guidance indicates improvement. The Q&A highlights effective sales force expansion and financial stability until 2027. Overall, the positive revenue growth, strategic expansion plans, and optimistic guidance outweigh the concerns, suggesting a positive stock price movement over the next two weeks.
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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.
