NYXH Q4 2025 Earnings Call Summary

Summary of Nyxoah Q4 2025 Earnings Call

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 increased from EUR 1.3 million in Q4 2024, reflecting strong growth driven by U.S. commercialization.
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 (stable compared to EUR 18.3 million in Q4 2024) and EUR 83.5 million for the full year (up from 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, generating EUR 4.5 million in revenue in Q4.
Surgeon Training: Trained 145 surgeons across 125 high-volume hypoglossal nerve stimulation accounts; 57 accounts received positive value analysis committee (VAC) approval.
Reimbursement: Secured consistent reimbursement from Medicare and commercial payers, with a facility fee of $31,526 established for Genio.
International Growth: Continued revenue contributions from markets like Germany, the UK, and the Middle East.

3. Forward Guidance and Outlook

2026 Revenue Guidance: Expect U.S. net revenue to grow 25% sequentially in Q1 and Q2 2026, with international revenue following seasonal patterns.
Sales Force Expansion: Increased sales team to 40 reps to cover 200 out of the top 400 hypoglossal nerve stimulation accounts.
Clinical Data: Anticipate 12-month data from the ACCCESS study by mid-2026, with a potential PMA supplement submission for U.S. label expansion in early 2027.

4. Bad News, Challenges, or Points of Concern

Operating Losses: Continued high operating losses reflect significant investments in commercialization, raising concerns about sustainability without revenue growth.
Cash Burn Rate: Estimated at EUR 20 million per quarter in the near term, which may pose risks if revenue growth does not accelerate as projected.
Competitive Pressures: Competitors are pursuing their own coding and may impact market share dynamics, particularly with LivaNova entering the market.

5. Notable Q&A Insights

VAC Submissions: 120 VAC submissions made with 57 approvals; further approvals expected in Q1 2026.
Implant Strategy: Emphasis on not loading shelves with excess inventory; implants are aligned with pre-identified patients.
Patient Adoption: Surgeons report strong interest in Genio due to its unique features, including bilateral stimulation and minimal invasiveness.
Future Coding: Plans to pursue dedicated coding for Genio, likely by early 2028, while navigating interim C-codes in the meantime.

Overall, Nyxoah demonstrated significant growth in Q4 2025 driven by its U.S. launch, but faces challenges related to operating losses and competitive pressures as it seeks to expand its market presence.

NYXH — Nyxoah S.A.