Nyxoah (NYXH) Q1 2025 earnings summary

Executive summary

• FDA issued an approval letter for Genio, confirming substantial compliance for U.S. marketing; final approval pending completion of a contract manufacturing site inspection, expected by end of Q2 2025.

• U.S. commercial launch preparations are complete, with a 50-member team in place and a two-pronged market entry strategy targeting high-volume implant centers and sleep physicians.

• Genio system differentiates with no implanted battery, bilateral stimulation, single-incision procedure, and robust clinical data, including unique evidence in positional OSA and supine sleep time.

• International expansion continues, with first Genio implants in Dubai and plans for further Middle East growth.

• Genio 2.1 software upgrade launched in international markets, enhancing patient comfort and autonomy.

Financial highlights

• Q1 2025 revenue was €1.1 million, down from €1.2 million in Q1 2024, due to temporary softness in the international HGNS market and deferred purchases related to the Genio 2.1 software upgrade.

• Operating loss increased to €20.6 million from €12.2 million year-over-year, driven by U.S. commercial investments and higher R&D and SG&A expenses.

• Cash position at March 31, 2025, was €63 million, compared to €85.6 million at year-end 2024.

• Gross margin was 61.8% in Q1 2025, compared to 62.7% in Q1 2024.

• Basic and diluted loss per share was €(0.598) for Q1 2025, compared to €(0.415) in Q1 2024.

Outlook and guidance

• Confident in receiving FDA PMA approval by end of Q2 2025, with U.S. commercial launch to follow.

• R&D spending expected to be in line with 2024; SG&A projected to more than double year-over-year, with heavier spend in early quarters.

• Cash runway extended into Q2 2026 through deferred discretionary and commercial spending.

• International market softness expected to be temporary, with recovery anticipated over the year.