Nyxoah Third Quarter 2026 Earnings Conference Call - NYXOAH SA

Explicit Guidance:

• Full Year 2026 Revenue: Updated guidance range of €33 million to €35 million (previously pre-announced; reflects a ramp rate for new technology as physicians build experience).
• Full Year 2026 Gross Margin: Expected range of 60% to 62%.
• 2027 Reimbursement Rates (2027): CMS final rule increases Hospital outpatient reimbursement (C8011) from $31,526 to $35,072 (+11%) and Surgical Center reimbursement from $27,563 to $31,283 (+13%).
• 2027 Guidance: No specific numbers provided; management deferred 2027 revenue and margin guidance to the Q4 2026 earnings release.

Business-Segment Outlook:

• U.S. Commercial Launch: Primary growth driver; focus shifting to driving utilization and "going deeper" within existing accounts rather than systematic pre-announcements. Q3 2026 U.S. revenue (€6.7M) achieved an annualized run rate of ~€27 million.
• Pipeline and Inflection Points: Awaiting FDA PMA supplement approval to expand Genio indication to Complete Concentric Collapse (CCC) patients (approx. 25% of U.S. OSA patients currently ineligible for existing therapies).
• International Markets: Expected to maintain solid growth alongside U.S. expansion; Q3 2026 international revenue grew 42% year-over-year.
• Capacity & Training: Current footprint includes 342 trained surgeons and 233 active accounts (as of Q3 2026); Q3 added 80 new surgeons and 53 new accounts. 447 patients in prior authorization program entering Q4 2026.
• Clinical Pipeline: BREATHE post-approval study initiated to build long-term real-world evidence for bilateral hypoglossal nerve stimulation in routine practice.

Market and Competitive Outlook:

• Market Dynamics: Management anticipates market expansion rather than contraction with multiple players (Genio, competitors); expects the entry of new technologies to increase overall OSA treatment adoption.
• Differentiation: Genio is positioned as the only bilateral HGNS therapy on the market, offering a streamlined patient journey and the ability to treat CCC patients.
• Pricing and Reimbursement: Facility reimbursement increases strengthen the economic value of the procedure; CMS and commercial payer coverage remains broad and stable.

Macro / Industry Outlook:

• Regulatory: High confidence in FDA review of PMA supplement; CCC indication is a critical milestone for market access.
• Reimbursement Environment: Finalized 2027 rate increases provide a tailwind for procedure economics.
• Clinical Landscape: Addressing an under-penetrated market where 1 in 4 patients (CCC) currently has no hyperglossal nerve stimulation option in the U.S.

Strategic Initiatives:

• Organizational Shift: Transitioning from an R&D/clinical development organization to a commercially-centric organization.
• Investment Allocation: Shifting spend from clinical/R&D toward commercial infrastructure; maintaining financial discipline to reduce cash burn.
• Commercial Execution: Recruiting and deploying sales reps (55 current reps) to increase productivity and drive growth through deeper account penetration.
• Capital Efficiency: Targeting continued reduction in quarterly cash burn while investing in high-return opportunities.

Risks and Headwinds to Outlook:

• Regulatory Delays: Outlook for CCC patient access depends on the timing and outcome of the FDA PMA supplement review.
• Commercial Ramp Speed: Revenue guidance assumes historical ramp rates for new technology; slower physician adoption could impact results.
• Execution Risk: Success relies on converting the growing base of physicians into increased procedure volumes.
• General Forward-Looking Risks: Material risks include uncertainties related to current estimates, assumptions, and factors detailed in the Form 20-F filed March 26, 2026.

Management Tone on the Future:

• Confidence Level: High confidence in the company's ability to build durable growth in the U.S. and improve patient care; describes the company as being at an "inflection point" for growth.
• Strategic Clarity: Clear prioritization of commercial execution and margin expansion; management expressed satisfaction with the "best-in-class" annualized run rate despite the FY2026 guidance adjustment.
• Guidance Philosophy: Explicitly stated intent not to systematically pre-announce revenue quarterly moving forward, signaling a shift to reporting actual results at standard intervals.

Miscellaneous:

• Cash Position: As of September 30, 2026, cash equivalents and financial assets totaled €77.1 million (down from €97.8 million at June 30, 2026).
• Operational Metrics: Q3 2026 gross margin reached 63.1% (up 260 bps YoY) due to volume leverage on cost of goods sold.