Nyxoah SA (NYXH) Q1 2026 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
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.
Key Financial Performance
Gross Revenue EUR 6.7 million before EUR 300,000 in deferrals due to the delivery of disposable patches, resulting in net revenue of approximately EUR 6.4 million. This represents 13% sequential worldwide growth compared to the fourth quarter of 2025.
U.S. Net Revenue EUR 4.3 million, representing approximately 25% sequential growth compared to EUR 3.4 million in the fourth quarter of 2025. Growth reflects continued expansion in account activation, increasing procedure volumes, and growing surgeon adoption.
Gross Margin 57% in Q1 2026 compared to 62% in Q1 2025. The decrease was due to production yield issues in the quarter, which have been addressed.
Operating Expenses EUR 24.2 million in Q1 2026 compared to EUR 21.4 million in Q1 2025. The increase was driven by increased investment in the U.S. commercial organization, including sales, marketing, and market access functions.
Non-GAAP Cash Operating Expenses EUR 21.7 million in Q1 2026 compared to EUR 19.5 million in Q1 2025. The increase reflects increased investment in the U.S. commercial organization.
Cash and Cash Equivalents and Financial Assets EUR 25.9 million as of March 31, 2026.
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Operating Highlights
Genio System: Trained 62 new surgeons in Q1, bringing the total to 207 surgeons trained. Expanded U.S. commercial field presence with 15 additional sales reps, covering up to 200 high-volume accounts by Q2. Conducted market research showing 88% of ENTs value multiple hypoglossal nerve stimulation options.
Genio 2.2 Upgrade: Planned launch in early 2027, featuring a new suite wearable with upgraded software and a low-cost disposable patch.
U.S. Market Expansion: Achieved 25% sequential U.S. revenue growth in Q1 2026 compared to Q4 2025. Expanded U.S. commercial field presence with 15 additional sales reps, covering up to 200 high-volume accounts by Q2. Estimated market share of 12%-14% in active accounts 6 months post-launch.
International Market Growth: Strong performance in Germany, continued therapy adoption in the Middle East, and successful entries in the U.K. and the Netherlands. Overcame seasonality to maintain consistent revenue compared to Q4 2025.
Reimbursement Landscape: Achieved 100% approval rate for prior authorization submissions under commercial payers and Medicare. CMS issued AGNS-specific C-codes for facilities, ensuring price parity for Genio and competitors.
Financial Management: Gross revenue of EUR 6.7 million in Q1 2026, with 13% sequential worldwide growth. Operating expenses increased due to U.S. commercialization efforts. Cash and cash equivalents totaled EUR 25.9 million as of March 31, 2026.
Focus on U.S. Commercialization: Reallocated resources from R&D and G&A to U.S. commercialization efforts. Strategic investments in sales, marketing, and market access to support growth.
Long-term Financial Goals: Aiming for gross margins over 80% and revenue breakeven below EUR 150 million. Disciplined approach to managing non-GAAP cash operating expenses while investing in growth drivers.
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Risk or Challenges
Gross Margin Decrease: The gross margin decreased from 62% in Q1 2025 to 57% in Q1 2026 due to production yield issues, which could impact profitability if not addressed effectively.
Operating Expenses Increase: Operating expenses increased from EUR 21.4 million in Q1 2025 to EUR 24.2 million in Q1 2026, driven by investments in U.S. commercial operations. This rise in expenses could strain financial resources if revenue growth does not keep pace.
Medicare Coding Uncertainty: The year began with coding uncertainty for Medicare, negatively impacting AGNS implants. Although CMS provided clarity in February, any future uncertainties could disrupt reimbursement processes and revenue.
Production Yield Issues: Production yield issues were reported in Q1 2026, contributing to the decline in gross margin. If these issues persist, they could hinder operational efficiency and financial performance.
Cash and Financial Assets: As of March 31, 2026, cash and financial assets totaled EUR 25.9 million, which may limit the company's ability to sustain prolonged high operating expenses or invest in growth initiatives without additional funding.
Reimbursement Landscape Challenges: While the company achieved a 100% approval rate for prior authorization submissions, the complex and evolving reimbursement landscape, including the introduction of new codes and modifiers, poses ongoing challenges.
Increased Competition: The market research indicates competition is seeking dedicated AGNS codes, which could intensify competitive pressures and impact market share.
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Guidance & Outlook
U.S. Net Revenue Growth: Expected to grow approximately 25% to 30% sequentially over the first quarter of 2026.
Full Year 2026 Worldwide Net Revenue: Projected to be in the range of EUR 36 million to EUR 40 million.
Gross Margin: Expected to be in the range of 60% to 62% for the full year 2026, with a long-term goal of exceeding 80%.
Operating Expenses: Total operating expenses for 2026 are expected to range between EUR 97 million and EUR 99 million, with non-GAAP cash operating expenses projected at EUR 88 million to EUR 90 million.
Strategic Investments: Focus on U.S. commercial activities, including sales, marketing, and market access, as well as R&D initiatives such as the Genio 2.2 upgrade, which includes a new wearable suite and low-cost disposable patch to be launched in early 2027.
Revenue Breakeven: Expected to achieve revenue breakeven below EUR 150 million in revenue.
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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 is the confidence in achieving the full-year 2026 revenue guidance, especially considering the ongoing reimbursement situation?
A:The company has added 50 new sales reps, bringing the total to 40, covering 200 out of 400 high-volume accounts. Surgeons are gaining experience, and there is positive feedback from initial cases. There are 91 active accounts out of 125 targeted sites, and 241 patients have submitted prior authorization files to commercial payers. Sequential growth rates are expected to accelerate in the second half of the year, with reimbursement being fully clear and supported by CMS and commercial payers.
Q:What is the longer-term strategy for Genio regarding a permanent CPT code?
A:For 2026, reimbursement is clear with CMS C codes and commercial payers. For 2027, no changes are expected on the Medicare side, and commercial coding might migrate to CPT 64582. For 2028, discussions are ongoing about dedicated CPT codes or a comprehensive AGNS coding set. The company is prepared to submit for a dedicated CPT code when appropriate and will follow the lead of specialty societies.
Q:What was the number of patients submitted under prior authorization at the end of Q4 2025 compared to Q1 2026, and how long does the approval process take?
A:At the end of Q4 2025, there were approximately 116 patients under prior authorization, which increased to 241 by the end of Q1 2026. The approval process takes up to 30 days, with a 100% approval rate so far. Implantation varies between 1 to 3 months depending on surgical scheduling.
Q:What is the breakeven point for the company, and what are the views on cash burn and gross margin improvements?
A:The breakeven revenue point is approximately EUR 150 million, with an 80% gross margin. Cash burn is being managed by reallocating capital to U.S. commercialization efforts and maintaining tight cash operating expenses. Gross margins are expected to improve from the low 60% range to over 70% by early 2027 with the introduction of the Genio 2.2 disposal patch and activation chip, and further improvements will come from volume-based pricing agreements with contract manufacturers.
Q:What are the core assumptions for Q2 U.S. revenue guidance and Medicare patient funnel expectations for the full year?
A:Q2 U.S. revenue guidance assumes 25% to 30% sequential growth, with further acceleration in the second half of the year. Medicare patients accounted for 10% to 12% in Q1 and are expected to grow to around 20% by year-end, with commercial payers remaining predominant.
Q:What is the dynamic in the field between Genio and Inspire V, and how does Genio gain patient selection?
A:Genio focuses on involving sleep physicians in patient management, starting with selection and continuing post-surgery. Patients are often introduced to Genio at high-volume sites, where they are informed about its benefits, such as no implanted battery and bilateral stimulation. The company limits direct-to-consumer spending and emphasizes partnerships with sleep physicians and high-volume surgeons.
Q:What caused the gross margin issues in Q1 2026, and what is the outlook for the rest of the year?
A:Gross margin issues in Q1 were due to production yield problems caused by turnover and training issues, which have since been resolved. A slight impact is expected in Q2, but margins should return to 63%-64% in the second half of 2026. A significant improvement to over 70% is expected in early 2027 with the Genio 2.2 disposal patch and activation chip.
Q:Why is the adjusted OpEx for Q1 2026 aligned with the low end of the full-year guidance, and what is the outlook for 2027?
A:Most U.S. commercial investments were made in Q1 2026, leading to consistent OpEx throughout the year. The company plans to leverage existing infrastructure built in 2025 to minimize additional investments. For 2027, the focus will remain on redeploying capital into growth drivers and margin improvement initiatives.
Q:Review of Unclear Management Responses
A:Management avoided directly addressing the question about how Genio would compete with Inspire V in terms of displacing cases on AGNS days. While they provided insights into their strategy involving sleep physicians and patient selection, they did not clearly explain how Genio would directly compete or displace Inspire cases in practice.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
AGNS code
AGNS technology
ASC setting
CMS
EUR cash
GA
Medicare
Nyxoah
UnitedHealthcare
WISeR program
account activation
account market
adoption
approach breakeven
approval rate
authorization submission
cash EUR
claim CPT
clarity AGNS
code AGNS
code facility
fee
field
increase cash
indicator surgeon
margin
market access
marketing
nerve stimulation
panel
payer
procedure volume
sale rep
setting CPT
use modifier
NYXH Transcript
Nyxoah SA (NYXH) Presents at Bank of America Global Healthcare Conference 2026 Prepared Remarks Transcript
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Nyxoah SA (NYXH) Q1 2026 Earnings Call Transcript
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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