Nyxoah's 2024 Q4 Earnings Call: Unpacking Contradictions in U.S. Market Strategy and Product Launch

These are the key contradictions discussed in Nyxoah's latest 2024Q4 earnings call, specifically including: U.S. Commercial Payer Adoption Timeline, Manufacturing Supply Chain and Product Availability, Reimbursement Strategy for Genio, and Timeline for U.S. Launch.



FDA Approval and U.S. Market Launch:
- Nyxoah anticipates FDA approval by the end of March 2025, which will enable the launch of Genio in the U.S. market.
- The confidence in meeting this timeline is due to a collaborative dialogue with the FDA and successful completion of labeling discussions.

Strong Clinical Efficacy and Safety:
- The DREAM study demonstrated a 63.5% AHI responder rate and an 71.3% ODI responder rate for Genio, with an overall median AHI reduction of 70.8%.
- These results are attributed to Genio's unique features, such as bilateral stimulation and the ability to maintain efficacy regardless of sleeping position.

Regulatory and Commercial Readiness:
- Nyxoah has built a world-class team in support of its U.S. go-to-market strategy, including hiring key personnel and establishing commercial readiness plans.
- This strategy focuses on targeting high-volume HGNS implanting centers and developing referral networks, aiming to penetrate the U.S. market within 12 to 18 months.

International Growth and Expansion:
- Nyxoah's growth in 2024 was primarily driven by the commercial execution in Germany, with a significant increase in revenue year-over-year.
- The company expanded its presence in Europe by launching Genio in the U.K. and the United Arab Emirates, driven by successful market penetration and expanding sales teams.

Revenue and Financial Performance:
- Nyxoah recorded €1.3 million in revenue for Q4 2024, with an expected full-year revenue of €4.5 million.
- The increase in revenue was primarily driven by deferring revenue related to disposable patches and ongoing commercial and clinical activities.