NYXH — Nyxoah S.A.

Nyxoah Q4 2025 Earnings Call Summary

1. Key Financial Results and Metrics

• Q4 2025 Gross Revenue: EUR 6.3 million (net revenue of EUR 5.6 million after EUR 700,000 in revenue deferrals).
• Q4 2024 Comparison: Revenue grew from EUR 1.3 million in Q4 2024, marking significant growth driven by the U.S. launch.
• Full Year 2025 Gross Revenue: EUR 11 million (net revenue of EUR 10 million after EUR 1 million in revenue deferrals), a 122% increase from EUR 4.5 million in 2024.
• Gross Margin: 64% in Q4 and 63% for the full year.
• Operating Loss: EUR 18.6 million in Q4 2025, slightly up from EUR 18.3 million in Q4 2024; full-year loss of EUR 83.5 million compared to EUR 58.8 million in 2024.
• Cash Position: EUR 48 million as of December 31, 2025.

2. Strategic Updates and Business Highlights

• U.S. Commercial Launch: Successfully launched Genio following FDA approval in August 2025; trained 145 surgeons across 125 high-volume accounts.
• Revenue Generation: Generated EUR 4.5 million in Q4 from the U.S. launch, with strong surgeon feedback on Genio's features.
• Reimbursement Success: Secured consistent reimbursement from Medicare and commercial payers, with new C-codes established for billing.
• International Growth: Continued revenue contributions from markets like Germany, the UK, and the Middle East.

3. Forward Guidance and Outlook

• 2026 U.S. Revenue Growth: Expected sequential growth of 25% in Q1 and Q2 2026.
• Sales Force Expansion: Increased to 40 sales reps, targeting 200 out of 400 high-volume accounts by mid-2026.
• Clinical Data: Anticipating 12-month data from the ACCCESS study by mid-2026, with potential PMA supplement submission for U.S. label expansion in early 2027.
• Gross Margin Improvement: Expected slight increase in gross margins in 2026, with a significant jump anticipated in early 2027 with the launch of Genio 2.2.

4. Bad News, Challenges, or Points of Concern

• Operating Loss Increase: Operating losses are rising due to heavy investments in U.S. commercialization.
• Cash Burn Rate: Estimated at EUR 20 million per quarter in the near term, raising concerns about sustainability without significant revenue traction.
• Competitive Pressures: Competitors are pursuing their own coding and may impact market dynamics; Nyxoah must differentiate Genio effectively.
• Reimbursement Landscape: Ongoing maturation of procedural coding practices could pose challenges as the market evolves.

5. Notable Q&A Insights

• Surgeon Training and Account Activation: 57 of 120 accounts have received VAC approvals, with expectations for more approvals in Q1 2026.
• Implant Numbers: While specific implant numbers were not disclosed, revenue figures suggest a strong uptake in the U.S. market.
• Market Differentiation: Surgeons favor Genio for its unique features, including bilateral stimulation and minimal invasiveness, which may help Nyxoah capture market share.
• Future Coding: Nyxoah is considering pursuing its own coding by 2028, aligning with industry trends.
• Patient Demographics: Patients are increasingly choosing Genio over traditional devices due to its user-friendly design and minimal invasiveness.

This summary encapsulates the key aspects of Nyxoah's Q4 2025 earnings call, highlighting financial performance, strategic initiatives, future outlook, and challenges faced in a competitive landscape.