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- **U.S. Launch Success**: 15 implants completed in first 7 weeks post-FDA approval, exceeding internal expectations.
- **Reimbursement Breakthrough**: 100% prior authorization approval rate, 35 VAC approvals secured.
- **Financial Strength**: EUR 26 million capital raise provides 18-month cash runway.
- **Gross Margin Path**: 80%+ achievable with Genio 2.2 launch in 2027.
- **Patient Impact**: 50-54 year-old patients driving early adoption, no CCC contraindication.

**【CEO Summary Section】**
- **U.S. Launch Momentum**: 15 implants completed across 9 accounts by end of October 2025, generating EUR 231,000 in revenue.
- **Surgeon Training Progress**: 111 surgeons trained on Genio, with 125 targeted accounts activated out of 400 high-volume sites.
- **Reimbursement Milestones**: 35 VAC approvals and 21 prior authorization submissions approved at 100% success rate.
- **Commercial Expansion**: 26 million EUR raised through private placement and convertible bonds, providing cash runway into Q1 2027.

**【CFO Financial Commentary】**
- **Revenue Growth**: Q3 2025 revenue EUR 2 million (56% YoY growth), driven by U.S. launch and international expansion.
- **Financial Health**: Operating loss EUR 24.4 million (76% YoY increase) due to commercialization investments.
- **Gross Margin**: 60.5% (down 1.5% YoY) reflecting early-stage launch costs.
- **Q4 Guidance**: EUR 3.4-3.6 million revenue, with U.S. implants expected to accelerate post-VAC approvals.

**【Q&A Key Highlights】**
- **Implant Cadence**: 15 implants in September, ramping to 26 million EUR in Q4 2025.
- **Reimbursement Clarity**: CPT Code 64568 fully recognized by Medicare and 10 private payers.
- **Sales Force Scaling**: 85-person U.S. sales team targeting 400 high-volume implant sites by Q4 2026.
- **Gross Margin Outlook**: 80%+ achievable with Genio 2.2 launch in 2027.
- **Patient Demographics**: 50-54 year-old average age, no CCC contraindication in U.S. label.

Nyxoah SA (NYXH) Q3 2025 Earnings Call Transcript

- **FDA Milestone**: GENIOR becomes first bilateral AGNS therapy approved in the US, addressing unmet needs for CCC and positional OSA patients.
- **Revenue Surge**: Q2 2025 revenue up 73.8% YoY to €1.3M, driven by US launch investments.
- **Clinical Excellence**: DREAM study demonstrates 85.9% compliance and 90% patient satisfaction, validating real-world effectiveness.
- **Market Momentum**: 100+ trained physicians and VAC approvals secured within first week of commercialization.
- **Strategic Growth**: €27.5M debt facility and scalable sales team expansion support 2026 US market dominance.

**【CEO Opening Remarks】**
- **FDA PMA Approval Achieved**: GENIOR system approved for bilateral AGNS therapy in the US, first of its kind.
- **Differentiated Label Features**: No contraindication for CCC, ability to treat positional OSA (AHI score doubles in supine position).
- **Clinical Validation**: DREAM study published with 85.9% compliance and 90% patient satisfaction.
- **US Launch Momentum**: 50-person commercial team targeting 400 high-volume centers; 100+ physicians trained.
- **Reimbursement Strategy**: Using CPT code 64568, same as competitors, with CMS and payer engagement underway.

**【CFO Financial Update】**
- **Revenue Growth**: €1.3M (Q2 2025) vs. €0.8M (Q2 2024), +73.8% YoY.
- **Gross Margin**: 63.4%, stable vs. prior year.
- **Operating Loss**: €19.9M (Q2 2025) vs. €13.3M (Q2 2024), driven by US commercial investments.
- **Cash Position**: €43M (June 2025) with €27.5M debt facility available.

**【Q&A Highlights】**
- **Commercial Metrics Focus**: Trained physicians, VAC approvals, pre-authorization rates.
- **Reimbursement Timeline**: First pre-authorization approvals in Q2 2025, broader coverage in 2026.
- **CCC Patient Strategy**: ACCESS study enrollment stopped; PMA supplement submission expected in Q1 2026.
- **Sales Team Expansion**: Adding 15 territory managers annually to scale coverage.
- **Competitive Positioning**: Bilateral stimulation differentiation vs. unilateral competitors.


Nyxoah SA (NYXH) Q2 2025 Earnings Call Transcript

- **FDA Approval Imminent**: Final FDA inspection underway, Q2 2025 approval expected for Genio system.
- **U.S. Launch Readiness**: 50-person commercial team trained; leveraging proven CPT code 64568 and competitive pricing with unique patient-centric features.
- **Financial Resilience**: €63M cash runway extended to Q2 2026; Q1 revenue down 8% YoY due to market softness and software upgrade delays.
- **Clinical Differentiation**: Only AGNS with positional OSA data; no implanted battery, bilateral stimulation, and single incision procedure.
- **Middle East Momentum**: First AGNS implants in Dubai, expanding to Gulf states with strong clinical demand.

**【CEO Summary Section】**
- **FDA Approval Progress**: Received approvable letter for Genio system; final manufacturing validation completed and FDA site inspection ongoing, targeting Q2 2025 approval.
- **U.S. Market Strategy**: Two-pronged approach - targeting high-volume implant centers and sleep physicians with moderate-to-severe OSA patients. 50 commercial team members hired and trained.
- **Differentiation**: No implanted battery, bilateral stimulation, single incision procedure; clinical data shows effectiveness in positional OSA and supine sleep.
- **Reimbursement**: Utilizing established CPT code 64568, pricing similar to competitors with unique technology benefits.

**【CFO Financial Commentary】**
- **Q1 2025 Financials**: Revenue €1.1M (down 8% YoY) due to international market softness and Genio 2.1 software upgrade delays.
- **Operating Expenses**: €20.6M (up 69% YoY) driven by U.S. commercial team investments.
- **Cash Position**: €63M as of March 2025, with plans to extend cash runway into Q2 2026 through deferred spending.

**【Q&A Key Points】**
- **FDA Inspection Details**: Site inspection ongoing, expected to conclude shortly; no deficiencies noted in prior inspection.
- **Genio 2.1 Software**: Rolled out in U.S. without delays; provides gradual stimulation ramp-up and patient autonomy within physician-set boundaries.
- **Middle East Expansion**: First implants in Dubai, expanding to Kuwait and Saudi Arabia; AGNS first in the region.
- **Reimbursement Strategy**: Dedicated team for pre-authorization support, leveraging existing payer familiarity with CPT code 64568.
- **ACCCESS Study**: Enrolling patients for CCC indication, targeting 12-month data submission for PMA supplement.
- **Cost Management**: R&D expenses ~2024 levels; SG&A expected to double YoY, front-loaded in 2025.

Nyxoah SA (NYXH) Q1 2025 Earnings Call Transcript

- **FDA Approval Near**: Genio expected to receive U.S. FDA approval by end of March 2025, leveraging CPT code 64568 for competitive pricing.
- **Clinical Superiority**: DREAM study shows 82% super responders and 66.6% AHI reduction in supine sleep, outperforming competitors without supine data.
- **U.S. Market Play**: 50-person team targeting 300+ high-volume sites; 75+ trained physicians ready for launch.
- **Cash Position Strong**: €85.6M cash on hand, supporting Q4 2024 operating loss of €18.3M due to launch investments.
- **International Momentum**: UK NHS coverage and UAE first implant highlight expansion beyond Europe's 18% 2024 growth.

**【CEO Summary Section】**
- **Clinical Trial Success**: Genio achieved 63.5% AHI responder rate and 71.3% ODI responder rate in the DREAM study, with 82% of patients becoming super responders (AHI <15). Supine sleep efficacy showed 66.6% AHI reduction, outperforming competitors without supine data.
- **FDA Approval Imminent**: Final PMA module submitted in June 2024; FDA interactions focus on labeling, with expected approval by end of March 2025. Genio will use CPT code 64568, same as existing HGNS tech, enabling competitive pricing.
- **U.S. Launch Strategy**: 50-person commercial team to target 300-350 high-volume HGNS sites and build referral networks with sleep physicians. Already trained 75+ U.S. physicians through clinical trials.
- **International Expansion**: Launched in UK (NHS coverage) and UAE; Germany revenue grew 46% QoQ in Q4 2024, with full-year growth of 18%.

**【CFO Financial Commentary】**
- **Revenue Performance**: Q4 2024 revenue €1.3M (excluding €0.6M deferred patch revenue), full-year €4.5M. Deferred revenue recognized over time as patches are delivered.
- **Financial Position**: Cash balance €85.6M at year-end (up from €57.7M), supported by €24.6M equity raise. Operating loss €18.3M in Q4, driven by R&D, commercial, and U.S. launch investments.

**【Q&A Key Themes】**
- **Reimbursement Strategy**: CPT code 64568 adoption expected to align pricing with competitors, with CMS coverage from launch. Commercial payers anticipated to approve by Q3/Q4 2025.
- **Market Uptake**: Genio's bilateral stimulation and non-pacemaker form factor differentiate from existing HGNS. Early focus on 75+ trained physicians and high-volume sites, scaling to 300+ accounts over 12-18 months.
- **Supply Chain Readiness**: U.S.-manufactured inventory sufficient for launch; no global shipping delays expected.
- **Real-World Data**: Post-market studies to collect clinical and economic evidence, supporting long-term adoption.


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