Nyxoah SA Q2 FY2025 earnings call

• FDA PMA approval for Genio system in the US, first bilateral HGNS approved for OSA; Genio not contraindicated for CCC and includes positional OSA in label.
• DREAM study published with 85.9% compliance and 90% patient satisfaction, strengthening US launch and international market access.
• Focused US launch with over 50 commercial professionals targeting high-volume implant centers and building referral networks with sleep physicians.
• Stopped ACCCESS study enrollment due to sufficient statistical power for CCC patients, aiming to add CCC indication to label by end of 2026/beginning 2027 using data from ACCCESS and European experience.
• Emphasis on Genio's differentiation with bilateral stimulation and unique design addressing patient needs like positional OSA.

In the second quarter of 2025, Nyxoah recorded revenue of EUR 1.3 million, an increase of 73.8% compared to EUR 800,000 in the second quarter of 2024. Gross margin was 63.4% in Q2 2025, essentially flat to the prior year. Total operating loss was EUR 19.9 million in Q2 2025, up from EUR 13.3 million in Q2 2024, driven by commercial investments in the US. Cash position was EUR 43 million as of June 30, 2025, down from EUR 63 million in Q1 2025, with EUR 27.5 million available under the term debt facility.

• The remainder of 2025 is expected to be transformative as Genio is established in the US market.
• Look forward to updating progress on the next earnings call.

• Patent lawsuit from Inspire Medical, but not expected to impact the US commercial launch which is already underway.

Q: Any year-end '25 metrics? Leading indicators to focus on? Trained physicians?

A: Leading indicators include number of trained physicians and value analysis committee applications. John Landry mentioned they'll track these and share more on the next quarterly call.

Q: How to leverage differentiated label like no CCC contraindication?

A: Olivier Taelman stated bilateral stimulation differentiates Genio, and the label confirms Genio's effectiveness in positional OSA and no CCC contraindication, helping convince physicians vs competitors.

Q: Which accounts are targeted first in commercial strategy?

A: Olivier Taelman said they target high-volume hypoglossal neurostimulation implanting centers and focus on patients with moderate to severe OSA who quit CPAP to build referral networks.

Q: Reimbursement process and timeline?

A: John Landry said they use CPT code 64568, work with payors, expect pre-authorizations in 2025 and coverage decisions in 2026.

Q: ACCCESS study timeline and CCC patient treatment?

A: Olivier Taelman said ACCCESS enrollment stopped, 12-month follow-up starts, data to be used for PMA supplement, aiming to add CCC indication to label by end of 2026/beginning 2027.

Q: Pricing and surgeon partnerships?

A: Olivier Taelman said they require physicians to have 5 defined patients meeting DREAM study criteria before training, and don't currently ask for specific market share but focus on quality training and patient cases.