Nyxoah (NYXH) investor relations material

Market overview and medical need

• Obstructive sleep apnea is a significant global health issue, with a $10 billion U.S. market and 500,000 eligible patients annually.

• Untreated sleep apnea increases risks for cardiovascular incidents, heart failure, stroke, and is highly prevalent among type 2 diabetes patients.

• 72% of type 2 diabetes patients also suffer from obstructive sleep apnea, highlighting the overlap of chronic conditions.

• Traditional treatments like CPAP masks and mandibular devices have limitations, especially for moderate to severe cases.

Technology and clinical evidence

• The Genio system uses a unique, battery-free, bilateral hypoglossal nerve stimulator, paired with a smart external wearable.

• Bilateral stimulation provides stronger therapeutic effects with less energy, improving patient comfort and MRI compatibility.

• The external wearable enables software updates and real-time sleep quality feedback via a smartphone app.

• Clinical trials met all primary and secondary endpoints, with 82% of patients reducing their apnea index below the treatment threshold.

• Severe adverse event rate is 8.7%, among the lowest in neuromodulation technologies.

Commercialization and financial performance

• Transitioned from clinical to commercial stage, focusing on high-volume U.S. centers and partnerships between sleep doctors and ENT surgeons.

• 207 surgeons trained and 91 active sites established in the U.S. within six months post-launch.

• 241 patients are pre-authorized for upcoming implants, with 40 sales reps now covering 200 of 400 high-volume accounts.

• Q1 revenue reached EUR 6.4 million globally (13% growth), with U.S. revenue at EUR 4.3 million (25% growth over Q4).

• Guidance for Q2 is 25%-30% U.S. growth over Q1, with annual revenue forecasted at EUR 36-40 million and gross margin expected to rise from 60%-62% to 80% as volume increases.