Nyxoah (NYXH) investor relations material

Executive summary

• 2025 marked a transformative year with FDA approval and U.S. commercial launch of Genio, leading to first U.S. implants and revenue in Q4.

• Achieved 347% year-over-year net revenue growth in Q4 2025, driven by the first full quarter of U.S. commercialization.

• Full year 2025 net revenue grew 122% year-over-year to EUR 10.0 million, reflecting strong U.S. launch post-FDA approval.

• 145 surgeons trained in 125 high-volume U.S. accounts, with 57 accounts receiving Value Analysis Committee (VAC) approval and activation by year-end.

• Genio's clinical efficacy and unique features, such as bilateral stimulation and single incision, differentiate it from competitors.

Financial highlights

• Q4 2025 net revenue was EUR 5.6 million (vs. EUR 1.3 million Q4 2024); full year 2025 net revenue: EUR 10.0 million (vs. EUR 4.5 million 2024).

• Q4 2025 gross margin: 64%; full year 2025 gross margin: 63%.

• Q4 2025 operating loss: EUR 18.6 million (vs. EUR 18.3 million Q4 2024); full year operating loss: EUR 83.5 million (vs. EUR 58.8 million 2024).

• Cash, cash equivalents, and financial assets at year-end 2025: EUR 48 million.

• Basic and diluted loss per share for 2025: EUR (2.364).

Outlook and guidance

• U.S. net revenue expected to grow 25% sequentially in both Q1 and Q2 2026, driven by surgeon training and VAC approvals.

• International revenue to follow typical seasonal patterns.

• Sales force expanded to 40 reps and 3 directors in Q1 2026, targeting 200 of the top 400 U.S. accounts.

• 12-month ACCESS study data expected by July 2026, with PMA supplement submission for potential label expansion in early 2027.

• Gross margin expected to increase slightly in 2026, with a step-up to ~70% in 2027 upon Genio 2.2 launch.