In This Article:
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Revenue: EUR1.3 million in Q4 2024; EUR4.5 million for the full year 2024.
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Deferred Revenue: EUR600,000 recorded in Q4 2024.
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Operating Loss: EUR18.3 million in Q4 2024, compared to EUR10.8 million in Q4 2023.
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Cash Position: EUR85.6 million as of December 31, 2024, up from EUR57.7 million at the end of 2023.
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Revenue Growth: 46% sequential growth in Q4 2024 over Q3 2024; 18% increase in full-year revenue over 2023.
Release Date: March 13, 2025
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) is well-positioned to bring its Genio system to the US market by the end of March 2025, with FDA approval expected soon.
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The DREAM study demonstrated strong efficacy for the Genio system, with a 63.5% AHI responder rate and a 71.3% ODI responder rate.
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Genio is the only therapy with clinical evidence proving its efficacy irrespective of a patient's sleeping position, a critical differentiator.
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The company has built a strong US-based team, including key hires in finance, medical, and commercial roles, to support the US launch.
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Nyxoah SA (NASDAQ:NYXH) has identified an established CPT code (64568) for reimbursement, aligning with existing HGNS technology pricing.
Negative Points
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The deferred revenue recognition for disposable patches may impact short-term financial results, with EUR600,000 deferred in Q4 2024.
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Operating loss increased to EUR18.3 million in Q4 2024, driven by R&D spending and US commercial investments.
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There is investor concern that the reimbursement level associated with the CPT code 64568 may not be attractive enough for physicians.
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The company faces challenges in ensuring sufficient manufacturing and inventory to meet demand upon US launch.
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There is uncertainty regarding the timing of commercial payer adoption and the potential hurdles in the reimbursement pathway.
Q & A Highlights
Q: Can you provide an update on the reimbursement strategy for Genio, specifically regarding the use of CPT code 64568? A: Olivier Taelman, CEO: We acknowledge that the physician fee associated with CPT code 64568 is not the strongest. However, having an established code is crucial for market entry. We are pleased to have identified this code, which is the same as the current HGNS technology. We plan to explore ways to optimize the code to reflect Genio's unique bilateral stimulation, potentially making it more attractive for physicians.
Q: How do you plan to approach the US market launch, and what is the expected pace of new account openings? A: Olivier Taelman, CEO: We have over 75 US physicians trained on Genio technology. Our strategy is to target high-volume HGNS implanting centers, which represent 70-75% of total HGNS revenue. We have a team of 50 trained sales professionals ready to launch, and we plan to scale up quarterly, aiming to cover all Tier 1 high-volume HGNS accounts within 12 to 18 months.