Nyxoah's Q1 2025 Earnings Call: Unraveling Contradictions in FDA Approvals, Reimbursement Strategies, and Seasonal Sales Impact

FDA approval timeline, reimbursement strategy and market access, manufacturing and inventory strategy, U.S. reimbursement and market access strategy, impact of seasonality on sales are the key contradictions discussed in Nyxoah SA's latest 2025Q1 earnings call.



U.S. Market Expansion and PMA Approval:
- Nyxoah SA is expecting to receive PMA approval for its Genio system in the U.S. in Q2 2025, following the completion of a successful manufacturing validation and on-site inspection.
- The approval is crucial for the company's market expansion strategy, focusing on high-volume hypoglossal nerve stimulation implanting centers and sleep physicians managing large patient populations with moderate to severe OSA.

Revenue Trends and Market Dynamics:
- Nyxoah recorded €1.1 million in revenue for Q1 2025, slightly down from €1.2 million in Q1 2024.
- The decrease was primarily due to temporary softness in the international HGNS market and the launch of Genio 2.1 patient software, which deferred certain purchases.

Investment in U.S. Commercial Organization:
- Nyxoah incurred a total operating loss of €20.6 million in Q1 2025, compared to €12.2 million in Q1 2024, driven by investments in the U.S. commercial organization.
- These investments are in preparation for FDA approval and subsequent commercial launch in the U.S. market.

Cash Position and Runway Extension:
- Nyxoah's cash position was €63 million at March 31, 2025, a decrease from €85.6 million at the end of 2024.
- The company has extended its cash runway into Q2 2026 by deferring commercial-related investments and other variable expenses, aligning with the expected U.S. FDA approval timeline.