[Management View]
Nyxoah received FDA PMA approval for its GENEO system, marking the first and only bilateral AGNS therapy for obstructive sleep apnea (OSA) in the US. Key metrics include a 73.8% revenue increase to $1.4 million in 2025, a gross margin of 63.4%, and an operating loss of $21.2 million due to accelerated US commercial investments. The company has a cash position of $45.9 million as of June 30, 2025.

[Outlook]
Nyxoah plans to expand its US commercial team, targeting high-volume AGNS implanting accounts and strengthening referral networks. The company aims to submit a PMA supplement for CCC indication after a twelve-month follow-up of access study patients, with potential FDA label addition by end of 2026 or early 2027.

[Financial Performance]
Revenue increased by 73.8% YoY to $1.4 million in 2025. Gross margin remained unchanged at 63.4%. Operating loss increased to $21.2 million from $14.2 million in 2024, driven by US commercialization investments.

[Q&A Highlights]
Question 1: Jon Block asked about year-end 2025 metrics and leading indicators for the GENEO launch.
Answer: John Landry highlighted tracking the number of physicians trained, value analysis committee (VAC) submissions, and pre-authorization approvals as leading indicators. More metrics will be shared in the next quarterly call.

Question 2: Jon Block inquired about leveraging the differentiated label for commercial strategy.
Answer: Olivier Taelman emphasized the importance of positional OSA efficacy and absence of CCC contraindication in the label. Bilateral stimulation is making a difference compared to unilateral stimulation, which will help convince physicians to choose GENEO.

Question 3: Kyle from Piper Sandler asked about the commercial strategy and targeted accounts.
Answer: Olivier Taelman explained the two-pronged approach focusing on high-volume AGNS implanting accounts and strengthening referral networks. The team will start with 25 territory managers, each responsible for 4-6 accounts, and will scale coverage quarterly.

Question 4: Kyle inquired about the reimbursement strategy and onboarding of larger payers.
Answer: John Landry detailed the comprehensive reimbursement strategy using CPT code 64568, with pre-authorizations expected this year and coverage decisions likely in 2026.

Question 5: Suraj Kalia asked about the decision to stop access study enrollment and patient outreach.
Answer: Olivier Taelman explained the statistical power of the current cohort and the plan to submit a PMA supplement after twelve-month follow-up. Patient outreach will leverage clinical data and focus on specific patient phenotypes.

Question 6: Matthew Park asked about the pace of account openings and potential headwinds.
Answer: Olivier Taelman noted the variability in VAC committee timelines, ranging from immediate approvals to up to nine months. The targeted approach aims for approvals within six months.

Question 7: Matthew Park inquired about operating leverage and spending in the back half of 2025 and into 2026.
Answer: John Landry indicated consistent R&D spending and increased SG&A due to US commercial investments, with SG&A potentially doubling in 2026.

Question 8: David Rescott asked about considerations in VAC and prior auth processes.
Answer: John Landry confirmed the approvals received and the demonstration of clinical efficacy using CPT code 64568. Olivier Taelman added that AGNS is now offered by multiple companies, providing options for physicians and patients.

Question 9: David Rescott inquired about the timeline for CCC patient treatment and access study results.
Answer: Olivier Taelman outlined the timeline for access study data and PMA supplement submission, with potential label addition by end of 2026 or early 2027. CCC patients are currently off-label in the US.

Question 10: Michael Polark asked about pricing strategy and return expectations from initial centers.
Answer: Olivier Taelman confirmed pricing aligned with Inspire's level and detailed the requirement for physicians to present five patient cases before training.

[Sentiment Analysis]
Analysts expressed positive sentiment, congratulating Nyxoah on FDA approval and the differentiated label. Management conveyed confidence in the US launch and strategic plans.

[Quarterly Comparison]
| Metric | Q2 2025 | Q2 2024 |
|-----------------------|---------------|---------------|
| Revenue | $1.4 million | $800,000 |
| Gross Margin | 63.4% | 63.4% |
| Operating Loss | $21.2 million | $14.2 million |
| Cash Position | $45.9 million | $67.3 million |

[Risks and Concerns]
Nyxoah faces patent litigation from Inspire Medical, which management asserts will not impact the US commercial launch. The company also needs to secure further regulatory approval for CCC indication.

[Final Takeaway]
Nyxoah's FDA approval for the GENEO system marks a significant milestone, positioning the company for a successful US launch. The differentiated label and strategic commercial approach targeting high-volume accounts and referral networks are expected to drive growth. While facing patent litigation and regulatory hurdles, Nyxoah's innovative technology and strong clinical data provide a solid foundation for future expansion.