Nyxoah (NYXH) investor relations material

U.S. launch progress

• FDA approval received August 8, with active launch starting August 11, focusing on 125 high-volume accounts covering 75% of U.S. volume.

• 128 surgeons trained and 108 VAC committee submissions made, with about half approved and a 100% approval rate so far.

• 100% approval on all pre-authorizations, with major private payers and CMS providing reimbursement.

• Sales force expanding from 25 to 40 territory managers by early 2026, targeting 200 high-volume accounts.

• Commercial organization totals 50 people, including market access and field engineers.

Financial outlook and market share

• Q4 2023 guidance is €3.4–€3.6 million; no FY26 guidance yet, but €28–€29 million would represent about 3% U.S. market share.

• Focused launch strategy aims for 15–25% share in targeted accounts, with some physicians expecting up to 50% market split.

• Early commercial outcomes in the U.S. are positive, with strong surgeon feedback and successful patient activations.

• Post-market registry required and ongoing to collect long-term data and support health economics.

Reimbursement and pricing

• Major reimbursement change for CPT code 64568 effective January 2026, increasing facility fees by 40–50%.

• Reimbursement changes expected to motivate hospitals and ASCs, with Genio technology well-suited for ASC use.

• Pricing strategy remains at parity with competitors, with no immediate plans to increase price.

• Long-term, expects a dedicated HGNS code and evolving reimbursement landscape as more companies enter.