This article first appeared on GuruFocus .
Release Date: May 12, 2026
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
Positive Points
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Nyxoah SA ( NASDAQ:NYXH ) achieved a 25% sequential U.S. revenue growth in Q1 2026 compared to Q4 2025, indicating strong execution of their U.S. launch.
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The company trained 62 new surgeons in Q1, bringing the total to 207 surgeons trained on the GENIOS system, enhancing their market presence.
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Nyxoah SA ( NASDAQ:NYXH ) maintained a 100% approval rate on reviewed prior authorization submissions, showcasing effective market access strategies.
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The company expanded its U.S. commercial field presence with 15 additional sales reps, enabling coverage of up to 200 high-volume accounts.
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International revenue remained consistent with Q4 2025, avoiding the typical sequential decline, and showing strong performance in markets like Germany and the Middle East.
Negative Points
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Gross margin decreased to 57% in Q1 2026 from 62% in Q1 2025 due to production yield issues, which have been addressed.
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Operating expenses increased to EUR 24.2 million in Q1 2026 from EUR 21.4 million in Q1 2025, driven by investments in the U.S. commercial organization.
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The company faces ongoing challenges with Medicare, which only represents approximately 10% of their cases, due to initial coding uncertainties.
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Despite the growth, Nyxoah SA ( NASDAQ:NYXH ) is still not at break-even, with a revenue target of EUR 150 million needed to achieve this.
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The company anticipates a slight gross margin impact in Q2 2026 due to units built in Q1 running through the P&L, delaying full margin recovery.
Q & A Highlights
Q: Can you discuss the confidence in achieving the full-year 2026 revenue guidance, especially considering the ongoing reimbursement situation? A: Olivier Talman, CEO: We have added 50 new sales reps, bringing the total to 40, which allows us to cover 200 out of 400 high-volume accounts. Surgeons are gaining experience, and we have 91 active accounts out of 125 targeted sites. We also have 241 patients submitted for prioritization, which gives us confidence in achieving strong double-digit growth, especially in the second half of the year. John Landry, CFO, added that revenue growth is expected to accelerate in the back half of the year, with sequential growth rates increasing from 25%-30% in Q2 to 40%-50% in Q4.
Q: What is the strategy for obtaining a permanent CPT code for Genio, and how does it relate to the recent AMA CPT panel meeting? A: Olivier Talman, CEO: For 2026, reimbursement is clear with CMS C codes and commercial payer coverage under CPT codes 64568 and 64582. For 2027, we expect no change on the Medicare side, and commercial codes may migrate to 64582. By 2028, there could be dedicated CPT codes for all AGNS technologies or a comprehensive AGNS coding set. We are prepared for both scenarios and will follow the lead of specialty societies.
Q: Can you provide details on the 241 patients submitted under prior authorization and the approval process timeline? A: Olivier Talman, CEO: At the end of Q1 2026, we had 241 patients submitted, up from 116 at the end of Q4 2025. Commercial payers have up to 30 days to approve, and we have maintained a 100% prior authorization approval rate. The timeline for getting patients through the approval process varies from one to three months, depending on surgical scheduling and site volume.
Q: What are the expectations for gross margin improvement, and how does it relate to production yield issues? A: John Landry, CFO: We experienced production yield issues in Q1, which have been resolved. We expect gross margins to improve starting in Q2 and continue throughout the year. The Genio 2.2 upgrade in early 2027 will further enhance margins, moving them from the low 60s to north of 70%. Long-term, we aim for gross margins over 80% through cost reductions and volume-based pricing with contract manufacturers.
Q: How does the dynamic between Genio and Inspire 5 play out in terms of device selection at sites? A: Olivier Talman, CEO: Our strategy involves partnering with sleep physicians for patient selection and management. Most patients arrive at hospitals seeking AGNS solutions, not specifically Genio. Once at the site, they are informed of their options, and many choose Genio due to its features like no implanted battery and bilateral stimulation. We focus on high-volume implanters and involve sleep physicians from the start, which has been effective in driving adoption.
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
