Nyxoah SA Q2 FY2024 earnings call

Product Development & Regulatory

• In March 2024, DREAM U.S. pivotal study achieved primary endpoints for Genio, with plans for FDA approval by end-2024 after filing the fourth module of PMA submission.
• Strengthened balance sheet with over EUR 85 million in new capital, extending cash runway to mid-2026.

Commercialization

• First half 2024 European sales at EUR 2 million (+29% vs H1 2023); 55 active implanting accounts in Germany.
• DREAM study met primary endpoints: AHI respond rate 63.5% (p=0.002) and ODI respond rate 71.3% (p<0.001); safety results favorable with 8.7% SAE rate.
• U.S. commercial strategy: Target Tier 1 non-stimulation implant sites (85% of U.S. procedures), structured sales team with territory managers, field engineers, and specialists.

In the second quarter ended June 30, 2024, revenue was EUR 780,000. For the first half of 2024, European sales were EUR 2 million, representing a 29% increase from the first half of 2023. The second quarter also saw 55 active implanting accounts in Germany.

Forward-Looking Statements

• Anticipate FDA approval of Genio as early as end-2024.
• Cash runway extended to mid-2026 with over EUR 85 million raised.
• U.S. commercial launch to target Tier 1 accounts with a scalable approach, starting with 15 territory managers.

Risks

• Material risks and uncertainties associated with forward-looking statements, including factors that could cause actual results to differ from expectations. Refer to Risk Factors section of Form 20-F.
• Potential variability in revenue due to limited implant volume in Germany and other markets.

Q: Lessons learned from Germany and translatability to U.S.?

A: Germany showed proof of concept, achieved market share above 30% in top accounts, and learnings will aid U.S. launch.

Q: U.S. reimbursement strategy?

A: Partnering with AAO for bridge CPT code, leveraging existing AG&S payment rates, engaging with payers.

Q: Revenue dynamics and competition?

A: Germany is a small revenue market, competition is healthy, but quarter-to-quarter variability exists due to limited implant volume.

Q: FDA approval timeline and U.S. sales team?

A: Confident in end-2024 FDA approval, starting with 15 territory managers supported by field engineers and specialists.

Q: Manufacturing ramp and breakeven?

A: Manufacturing ramp progressing, aiming for scalable production, anticipating profitability at ~$250M sales in the U.S.

Q: Reaction to SURMOUNT OSA study and GLP-1 impact?

A: GLP-1s expand OSA market, SURMOUNT data shows hypoglossal nerve stimulation more effective, GLP-1s enhance patient funnel for Genio.