Nyxoah SA Q3 FY2025 earnings call

• Olivier Taelman discussed Genio's U.S. launch following FDA approval on August 8, noting strong enthusiasm from the ENT and sleep communities. The first commercial Genio implant in the U.S. generated $231,000 in revenue in Q3. • 111 surgeons trained on Genio out of 125 targeted accounts, 102 value analysis committee submissions with 35 approvals, and 63 prior authorizations with 21 approvals. Reimbursement secured with Medicare and 10 private payers. • John Landry provided financial updates, including Q4 revenue guidance and the $77 million financing secured to drive Genio's commercialization. • Olivier highlighted Nyxoah's focus on managing sleep apnea as a chronic condition, integrating AI and self-learning in next-generation Genio to create a patient-centric ecosystem.

In the third quarter of 2025, Nyxoah recorded revenue of EUR 2 million, an increase of 56% compared to EUR 1.3 million in the third quarter of 2024. Gross margin in Q3 2025 was 60.5% vs 62% in Q3 2024. Total operating loss was EUR 24.4 million vs EUR 15 million in Q3 2024. For the fourth quarter of 2025, global revenue is expected to be between EUR 3.4 million and EUR 3.6 million. The company secured up to $77 million in capital to bolster its balance sheet, including a private placement of equity and a convertible bond, providing cash runway into Q1 2027.

• Q4 2025 global revenue expected between EUR 3.4 million and EUR 3.6 million. • Secured up to $77 million in capital, providing cash runway into Q1 2027. • Proceeds from financing, combined with current capital, expected to support commercialization into 2027.

• Forward-looking statements involve material risks and uncertainties that could cause actual results to differ from expectations. • Risks associated with commercialization, including training physicians, obtaining value analysis committee approvals, and securing payer coverage. • Dependence on successful execution of early commercialization steps and reimbursement processes.

Q: Congrats on the progress. Could you provide feedback from docs and patients on why they're choosing Genio versus other options?

A: Physicians are excited about optionality, Genio's bilateral stimulation, and patient-centric design. Patients value choice in treating OSA and the implant-for-life approach.

Q: Adam Maeder asked about Q4 guidance and U.S. vs OUS breakdown.

A: John Landry stated Q4 guidance reflects acceleration of U.S. implants and growth in Germany/U.K., but no breakdown of U.S. vs international.

Q: Suraj Kalia asked about initial implants' appeal and Genio's slotting in hospitals.

A: Olivier Taelman mentioned Genio's differentiation from pacemaker technology, appeal to both male and female patients, and enthusiasm from physicians.

Q: Jonathan Block asked about KPIs for transparency.

A: John Landry said short-term KPIs like surgeons trained, accounts implanted, VAC figures will be provided quarterly.

Q: David Rescott asked about ASP, gross margins, and future gross margin improvement.

A: John Landry discussed average selling price around $25,000, and long-term goal of 80% gross margin with next-gen Genio and volume scaling.

Q: Paige Chamberlain asked about reimbursement phasing and coding.

A: Olivier Taelman confirmed CPT Code 64568 is used, and progress in reimbursement with payers familiar with HGNS.