NYXH — Nyxoah S.A.

Summary of Nyxoah Q3 2025 Earnings Call

1. Key Financial Results and Metrics

• Revenue: EUR 2 million in Q3 2025, up 56% from EUR 1.3 million in Q3 2024.
• Gross Margin: 60.5%, slightly down from 62% in Q3 2024.
• Operating Loss: EUR 24.4 million, compared to EUR 15 million in Q3 2024, primarily due to increased commercial investments in the U.S.
• Cash Position: EUR 22.5 million as of September 30, 2025, down from EUR 43 million at June 30, 2025.
• Capital Raise: Secured up to $77 million in financing, including a $25 million equity placement and a $52 million convertible bond.

2. Strategic Updates and Business Highlights

• U.S. Launch of Genio: Following FDA approval on August 8, 2025, the U.S. launch has seen strong enthusiasm from ENT and sleep communities.
• Surgeon Engagement: 111 out of 125 targeted surgeons trained on Genio, with 15 implants performed across 9 accounts within the first 12 weeks post-launch.
• Reimbursement Progress: Secured reimbursements from Medicare and 10 private payers, with a 100% approval rate on prior authorization submissions.
• Market Penetration: Focus on high-volume hypoglossal nerve stimulation sites, with plans to expand the sales force by adding territory managers quarterly.

3. Forward Guidance and Outlook

• Q4 2025 Revenue Guidance: Expected to be between EUR 3.4 million and EUR 3.6 million, reflecting continued growth in U.S. implants and sustained performance in Germany and the U.K.
• Long-term Gross Margin Target: Aiming for gross margins in the 80% range as production scales and new product enhancements are introduced.

4. Bad News, Challenges, or Points of Concern

• Increased Operating Loss: The significant increase in operating loss raises concerns about the sustainability of current spending levels amid aggressive commercialization efforts.
• Cash Burn: The decline in cash reserves from EUR 43 million to EUR 22.5 million may necessitate further capital raises if losses continue at this rate.
• Slow Implant Adoption: Only 15 implants performed by the end of October, indicating a slower-than-expected ramp-up in adoption despite initial enthusiasm.

5. Notable Q&A Insights

• Surgeon and Patient Feedback: Surgeons appreciate the optionality and bilateral stimulation offered by Genio, which is resonating well with patients.
• Sales Force Expansion: Plans to add up to 15 territory managers quarterly to enhance coverage of high-volume implanting centers.
• Reimbursement Dynamics: The current CPT Code 64568 is expected to remain in use for the foreseeable future, facilitating reimbursement processes.
• Logistical Challenges: The timing of prior authorization approvals and implant procedures is impacting the number of implants performed, with a typical cycle time of about four weeks from submission to payment.

Overall, while Nyxoah is experiencing positive momentum with its U.S. launch and reimbursement efforts, challenges remain regarding operating losses and the pace of implant adoption. The company is focused on executing its commercialization strategy and expanding its market presence.