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- **Revenue Growth**: Q3 $13.5M (+29% YoY), full-year guidance raised to $51-52M. 
- **Accelerated Protocol**: 6-day MDD treatment protocol driving demand. 
- **Strategic Investments**: $20M equity in mental health providers and Neurolief (up to $11M convertible loan). 
- **Financial Strength**: 75% gross margin, $70.7M cash, updated guidance for 6-7% operating profit. 
- **Global Expansion**: APAC and Europe key growth markets.

**【CEO Summary Section】**
- **Record Q3 Revenue**: $13.5 million, up 29% YoY, driven by 90 Deep TMS systems shipped (43% YoY increase). Full-year guidance raised to $51-52 million (from $50-52 million). 
- **Accelerated Protocol Adoption**: FDA-approved 6-day MDD treatment protocol (vs. 4-week traditional), with early demand signals. 
- **Minority Investments**: $20 million strategic equity investment in mental health providers (e.g., Stella Mental Health, Axis) and Neurolief (up to $11 million convertible loan). 
- **Lease Model Dominance**: 70% of sales via multi-year leases, with $65 million remaining performance obligations. 

**【CFO Financial Commentary】**
- **Gross Profit**: $10.2 million (75% margin), stable vs. prior year. 
- **Operating Expenses**: $4.7M (Sales/Marketing), $2.4M (R&D), $1.8M (G&A), driven by strategic initiatives. 
- **Cash Flow**: $70.7 million ending cash, positive operating cash flow. 
- **Guidance Update**: Operating profit 6-7% of revenue (vs. 4-5%), EBITDA 13-14% (vs. 12-13%). 

**【Q&A Highlights】**
- **Accelerated Protocol**: CEO expects adoption to boost patient convenience and demand. 
- **Minority Investments**: Pipeline for 2026 includes high-growth, profitable enterprises. 
- **Neurolief Update**: FDA clearance anticipated by end-2025, targeting VA, IDNs, and TMS clinics. 
- **International Growth**: Focus on APAC (Japan, China, India) and Europe (Germany, France).

BrainsWay Ltd. (BWAY) Q3 2025 Earnings Call Transcript

- **Revenue Record**: Q2 2025 revenue of $12.6 million (+26% YoY) driven by 88 Deep TMS systems shipped.
- **Recurring Revenue Dominance**: 70% of engagements via multiyear leases, with $62 million backlog.
- **FDA Milestone**: Accelerated TMS protocol submission; FDA response expected by Q4 2025.
- **Strategic Growth**: $5 million invested in Stella MSO; targeting 5-10 similar deals by end-2026.
- **Financial Strength**: $78.3 million cash, updated 2025 guidance of $50-52 million revenue.

**【CEO Summary Section】**
- **Record Revenue Growth**: Q2 2025 revenue reached $12.6 million, a 26% year-over-year increase, driven by 88 Deep TMS systems shipped (35% YoY growth) and a total installed base of 1,522 systems.
- **Recurring Revenue Model**: 70% of customer engagements are multiyear lease agreements, with a backlog of $62 million in remaining performance obligations.
- **Strategic Focus**: Three pillars include expanding market awareness, advancing R&D (e.g., accelerated TMS protocol submitted to FDA), and global expansion. The FDA is expected to respond by Q4 2025 on the accelerated protocol, which reduces treatment duration from 6 weeks to 6 days.
- **Strategic Investments**: $5 million invested in Stella MSO, with plans for 5-10 similar minority investments by end-2026, targeting mental health networks.

**【CFO Financial Commentary】**
- **Financial Highlights**: Gross profit of $9.5 million (75% margin), operating profit of $600,000, and net profit of $2 million. Cash reserves stand at $78.3 million, up $30.2 million YoY.
- **Expense Growth**: Sales & marketing (+30%), R&D (+35%), and G&A (+14%) reflect investments in commercial expansion, clinical trials, and strategic initiatives.
- **Guidance Update**: Full-year 2025 revenue guidance raised to $50-52 million (22-27% growth), with operating profit targeting 4-5% of revenue and EBITDA 12-13%.

**【Q&A Key Highlights】**
- **Accelerated Protocol Commercialization**: FDA response expected by Q4 2025; potential to increase patient accessibility and utilization.
- **Sales Team Expansion**: 26 FTEs (16 sales, 10 practice development) supporting U.S. and international growth.
- **OCD Placements**: 30 OCD systems shipped in Q2, aligning with expanding clinical indications.
- **Strategic Investment Success**: Stella MSO partnership achieved a 50% increase in TMS utilization, showcasing the value of technology + training collaborations.

BrainsWay Ltd. (BWAY) Q2 2025 Earnings Call Transcript

- **Revenue Growth**: 27% YoY to $11.5M, driven by 81 systems shipped (42% YoY)
- **Clinical Leadership**: 60%+ OCD response rate, 1st FDA-cleared TMS for OCD & PTSD reimbursement expansion
- **Financial Health**: 75% gross margin, $72M cash, 20-24% 2025 revenue growth guidance
- **Pipeline Progress**: Accelerated MDD protocol FDA clearance expected Q4 2025, psychedelic-TMS trial Q3 launch

**【CEO Key Highlights】**
- Q1 2025 Revenue: $11.5M (27% YoY growth), Systems Shipped: 81 units (42% YoY), Backlog: ~$60M
- **Market Expansion**: 80% of new sales from greenfield customers, 20% from competitive conversions
- **Clinical Momentum**: 
  - OCD Response Rate: 60%+ (1st FDA-cleared TMS for OCD)
  - PTSD Reimbursement Expansion in Israel
  - Accelerated MDD Protocol Submission to FDA expected Q4 2025
- **Revenue Models**: Pay-per-use in Israel, multi-year agreements with large networks
- **Gross Margin**: Consistent 75% despite geopolitical trade policy monitoring

**【CFO Financial Breakdown】**
- Q1 2025 Financials:
  - Revenue: $11.5M (27% YoY)
  - Gross Profit: $8.6M (75% margin)
  - Operating Expenses: $7.9M (Sales: $4.2M, R&D: $2.3M, G&A: $1.5M)
  - Net Income: $1.1M (vs $0.1M YoY)
  - Cash Position: $72M
- **Full Year 2025 Guidance**: 
  - Revenue: $49-51M (20-24% YoY growth)
  - Operating Margin: 3-4%
  - Adjusted EBITDA: 11-12%

**【Q&A Key Takeaways】**
1. **Clinical Trials**: 
   - Accelerated MDD Protocol FDA Clearance expected Q4 2025
   - PTSD & Adolescent MDD Data Submissions Q4 2025
   - Psychedelics + TMS Combination Trial Launch Q3 2025
2. **Product Adoption**: 
   - 57 OCD Coils Shipped Q1, Total Installed Base: ~850
   - TMS 360 System: Mix of upgrades & new installations for addiction/dementia
3. **Financial Strategy**: 
   - No immediate stock buyback plans; prioritizing R&D & growth
   - No material impact from trade policies on 2025 gross margin

BrainsWay Ltd. (BWAY) Q1 2025 Earnings Call Transcript

- **Revenue Acceleration**: Q4 2024 up 27% YoY to $11.4M; full year $41M (29% growth). 2025 guidance: $49-51M (20-24% growth). 
- **Enterprise Dominance**: 75 systems shipped (25% YoY), enterprise accounts driving repeat orders. 
- **Clinical Breakthroughs**: First TMS for OCD, elderly MDD, and AUD pilot success. 
- **Pipeline Momentum**: TMS 360 AUD trial Q3 2025; accelerated MDD data Q3 2025. 
- **Financial Strength**: $69.4M cash, 75% gross margin, 6+ quarters of EBITDA positivity. 
- **Strategic Focus**: Organic growth via R&D, partnerships, and psychedelic clinic expansion.

**【CEO Key Highlights】**
- **Revenue Growth**: Q4 2024 revenue of $11.4M (27% YoY), full year $41M (29% YoY). 2025 guidance: $49-51M (20-24% growth). 
- **Enterprise Sales Momentum**: 75 systems shipped in Q4 (25% YoY), book-to-bill ratio >1.0. Large enterprise accounts driving repeat orders. 
- **Clinical Expansion**: 
  - OCD treatment (first TMS approved for resistant OCD) with 60%+ response rates. 
  - Elderly MDD (FDA expanded age limit to 86). 
  - AUD pilot study showing efficacy with accelerated protocol. 
- **Pipeline Progress**: 
  - TMS 360 multi-center trial for AUD in H2 2025. 
  - Accelerated MDD protocol data expected Q3 2025. 
  - Feasibility studies for Alzheimer's/Parkinson's with TMS 360. 
- **Financial Strength**: $69.4M cash as of Dec 2024, no debt. 75% gross margin maintained. 

**【CFO Financial Summary】**
- **Topline**: Q4 2024: $11.4M (27% YoY). Full year: $41M (29% YoY). 
- **Gross Margin**: 75% Q4 and full year. 
- **Profitability**: 
  - Q4 net income $1.5M (vs $0.1M YoY). 
  - 6 consecutive quarters of positive EBITDA ($1.4M Q4, $4.5M full year). 
  - Operating income 3-4% of revenue in 2025. 
- **Balance Sheet**: $69.4M cash, including $20M from Valor Equity. 

**【Q&A Key Takeaways】**
1. **Sales Drivers**: Enterprise accounts, OCD demand, elderly MDD utilization. 
2. **Protocol Timing**: Accelerated MDD data Q3 2025; AUD trial H2 2025. 
3. **Margin Outlook**: 75% gross margin maintained in 2025. 
4. **Partnerships**: Growing psychedelic therapy clinics adopting Deep TMS. 
5. **Regulatory Tailwinds**: PTSD reimbursement expansion in Israel; reduced MDD treatment failures threshold. 
6. **Organic Growth Focus**: No active M&A plans; investing in R&D and enterprise partnerships.

BrainsWay Ltd. (BWAY) Q4 2024 Earnings Call Transcript

BrainsWay Ltd. (BWAY) Q2 2024 Earnings Call Transcript

- **Revenue Surge**: Q1 2024 revenue up 37% YoY to $9.1 million, with 57 systems shipped and 1,158 total installed base.
- **Profitability Milestones**: 75% gross margin, positive net income and EBITDA for third straight quarter.
- **Growth Drivers**: Katie’s Way Plus expands to 40 systems; international expansion in Korea, Taiwan, India.
- **Pipeline Progress**: Neurology CE Mark approvals, short protocol clinical trial, and addiction partnerships in development.
- **Cash Position**: $47.8 million cash, with plans to reinvest in sales, marketing, and R&D while maintaining profitability.

**【CEO Summary Section】**
- **Revenue Growth**: Q1 2024 revenue of $9.1 million, up 37% YoY, driven by 57 Deep TMS systems shipped (vs. 42 in Q1 2023). Total installed base reached 1,158 systems (+24% YoY). 
- **Profitability**: Gross margin improved to 75% (vs. 73% YoY), with $6.8 million gross profit. Positive net income ($100k) and EBITDA ($700k) for the third consecutive quarter.
- **Market Expansion**: Strong demand in U.S. and international markets (Korea, Taiwan, India). 18 new systems ordered by Katie’s Way Plus, expanding to 40 devices. Israel expansion supported by increased reimbursement rates.
- **Product Adoption**: 50% of installed base now includes OCD coils. New Deep TMS 360 clinical trial launched for accelerated protocols.
- **Leadership Updates**: Appointed Honny Groen as VP of International Sales and Dr. Musayev as CTO to drive global growth and R&D.

**【CFO Financial Commentary】**
- **Top Line Guidance**: Reaffirmed 2024 revenue guidance of $37-40 million (16-26% YoY growth). Q1 bookings on track with strong backlog.
- **Cost Efficiency**: Operating expenses down 21% YoY to $6.7 million. Sales & marketing expenses reduced 22% to $3.8 million.
- **Liquidity**: $47.8 million cash on hand (no debt), with third consecutive quarter of positive cash flow.

**【Q&A Key Highlights】**
- **Geographic Expansion**: Focus on Korea, Taiwan, India, and Europe. U.S. demand strong across all states.
- **Clinical Pipeline**: 
  - Neurology indications (Parkinson’s, epilepsy) gaining traction internationally with CE Mark.
  - Short protocol clinical trial with FDA to reduce treatment duration.
  - Addiction partnerships in development, with potential agreements by end-2024.
- **Customer Mix**: Growth from both new customers (mid-sized mental health networks) and existing accounts expanding capacity.
- **Capital Allocation**: Plans to reinvest cash into sales team expansion, marketing, and R&D while maintaining profitability.
- **Reimbursement Trends**: Insurance standards shifting to require failure of 1-2 medications before Deep TMS, up from 3-4 previously, driven by cost savings and efficacy data.

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