NYXH — Nyxoah S.A.

Nyxoah Q1 2026 Earnings Call Summary

1. Key Financial Results and Metrics

• Gross Revenue: €6.7 million, net revenue approximately €6.4 million after €300,000 in deferrals.
• Sequential Growth: 13% worldwide growth from Q4 2025; U.S. revenue of €4.3 million, reflecting a 25% sequential increase.
• Gross Margin: 57%, down from 62% in Q1 2025, attributed to production yield issues.
• Operating Expenses: €24.2 million, up from €21.4 million in Q1 2025, driven by investments in U.S. commercialization.
• Cash Position: €25.9 million in cash and equivalents, with plans to draw €13.8 million from a European Investment Bank loan.

2. Strategic Updates and Business Highlights

• U.S. Commercialization: Second full quarter of U.S. launch with strong execution, including the addition of 15 sales reps, bringing total to 40, covering 200 high-volume accounts.
• Surgeon Training: 62 new surgeons trained in Q1, totaling 207 trained on the Genio system.
• Market Research: 88% of ENTs see value in having multiple hypoglossal neurostimulation options; strong surgeon feedback on Genio's features.
• Reimbursement Landscape: Stable coverage from commercial payers, with a 100% approval rate on prior authorization submissions.

3. Forward Guidance and Outlook

• 2026 Revenue Growth: U.S. net revenue expected to grow 25% to 30% sequentially; worldwide net revenue forecasted between €36 million and €40 million.
• Gross Margin Expectations: Projected to improve to 60%-62% for the year, with long-term goals of exceeding 80%.
• Operating Expenses: Expected to be between €97 million and €99 million for the full year, with non-GAAP cash operating expenses between €88 million and €90 million.

4. Challenges and Points of Concern

• Gross Margin Decline: The drop in gross margin due to production yield issues raised concerns, though management expects recovery in subsequent quarters.
• Operating Expense Growth: Increased operating expenses may pressure profitability, although investments are aimed at supporting growth.
• Reimbursement Uncertainty: While current reimbursement is stable, future coding changes for AGNS technologies could pose risks.

5. Notable Q&A Insights

• Confidence in Revenue Guidance: Management expressed confidence in achieving revenue targets, citing increased sales force productivity and positive surgeon feedback.
• Medicare Patient Projections: Medicare cases are expected to grow from 10%-12% to around 20% by year-end, though commercial payers will remain predominant.
• Competitive Dynamics: The company is focusing on partnerships with sleep physicians to enhance patient referrals and adoption of Genio, while maintaining limited direct-to-consumer spending.
• Future Coding Strategy: Nyxoah is preparing for potential changes in reimbursement coding, with plans to submit for dedicated CPT codes as needed.

Overall, Nyxoah reported a solid start to 2026, with significant growth in U.S. revenue and ongoing investments in commercialization, despite challenges in gross margin and operating expenses. The company remains optimistic about its future growth trajectory and market positioning.