Nyxoah SA Q1 FY2025 earnings call

FDA Approval Progress - The FDA issued an approvable letter for the Genio system, which substantially meets requirements for marketing in the U.S. - Successfully completed validation of a specific manufacturing process at the U.S. contract manufacturing site and submitted documentation to the FDA, with the FDA having no further questions regarding it. - Ongoing on-site inspection of the U.S. contract manufacturing facility, with confidence in completing the final step and expecting PMA approval in Q2 2025. ### U.S. Commercial Readiness - Built a world-class U.S. commercial team of 50, including sales, marketing, and market access professionals. - Two-pronged strategy for the U.S. market: target high-volume hypoglossal nerve stimulation implanting centers and develop networks with sleep physicians managing moderate to severe OSA patients. - Working on reimbursement with the American Academy of Otolaryngology and participating in the FDA's early payer feedback program, using CPT code 64568 at launch. ### Product Features - Genio system designed with patient comfort and convenience in mind, including no implanted battery and single incision procedure. - Genio 2.1 software upgrade provides patient comfort and physician flexibility in ramping up stimulation. ### International Commercial - Successful first implants in Dubai, with plans to open a second hospital in Dubai and expand to Kuwait and Saudi Arabia. - ACCCESS study ongoing, with enrollment expected to stop by summer, leading to 12-month data submission as a PMA supplement.

In the first quarter of 2025, Nyxoah recorded revenue of €1.1 million, compared to €1.2 million in the first quarter of 2024. The slight year-over-year revenue decrease was primarily due to temporary softness in the international HGNS market. Additionally, the launch of the Genio 2.1 patient software upgrade commercially via a phased approach resulted in certain Genio sites deferring their purchase until the upgrade of patient software was available. Revenue contribution details weren't specified beyond the absolute figures and the reason for the decrease.

FDA Approval - Confident in receiving PMA approval in the second quarter of 2025 based on ongoing site inspection progress. ### Publication - DREAM Journal publication expected before summer, with the review process moving to the second level and questions being addressed. ### OpEx Spending - R&D expected to be in line with 2024 levels. SG&A expected to be more than double 2024 levels, with the first couple of quarters being heavier than the back quarters. ### U.S. Commercial Team - Plan to scale the U.S. commercial team each quarter post-FDA approval in tandem with opening new implant accounts.

Material Risks - Forward-looking statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. Risks are detailed in the Risk Factors section of Form 20-F filed with the SEC on March 20, 2025.

Q: Jon Block asked about the U.S. inspection versus the initial one in the FDA process.

A: Olivier Taelman explained that the FDA requested validation of a specific manufacturing process, which was completed and submitted, and the ongoing site inspection is part of the regulatory process, with confidence in obtaining approval by the end of the quarter.

Q: Adam Maeder inquired about the FDA approval timeline and DREAM Journal publication.

A: Olivier Taelman stated the site inspection is ongoing, and the publication is in the second review level with questions being addressed, expected before summer. John Landry discussed OpEx spending with R&D in line and SG&A to increase.

Q: Ross Osborn asked about the Dubai commercial launch and ACCCESS study.

A: Olivier Taelman said first implants in Dubai, with plans to expand, and ACCCESS study enrollment expected to stop by summer with 12-month data submission as a PMA supplement.

Q: Suraj Kalia asked about inventory and sales force.

A: Olivier Taelman said existing inventory of competition products won't be an issue, and sales force is hired based on heat maps of high-volume sites.

Q: David Rescott asked about software upgrades and reimbursement.

A: John Landry said Genio 2.1 will be available in the U.S., and a market access team is in place to handle reimbursement with pre-authorization materials.

Q: Michael Polark asked about CCC labeling.

A: Olivier Taelman clarified CCC won't be on label initially, and physicians will need to do DISE to exclude CCC patients, with adaption to new measurement methods if accepted.

Q: Laura Roba asked about cash runway and HGNS market softness.

A: John Landry said temporary softness in HGNS market is expected to recover, and discretionary variable expenses are deferred to extend cash runway into Q2 2026.