BrainsWay Ltd. Q2 FY2025 earnings call

• Recorded quarterly revenue of $12.6 million, a 26% y-o-y increase.
• Shipped 88 Deep TMS systems, a 35% y-o-y increase, with installed base at 1,522 systems.
• Multiyear lease agreements account for ~70% of customer engagement.
• Backlog of $62 million provides visibility into future revenue.
• Focus on 3 pillars: elevating market awareness of Deep TMS, advancing R&D roadmap for new indications, and broadening patient access via global expansion.
• Submitted data to FDA on accelerated TMS protocol for major depressive disorder.
• Invested in mental health providers, with initial $5 million investment in Stella MSO.

In the second quarter of 2025, BrainsWay reported record quarterly revenue of $12.6 million, a 26% increase compared to the same period last year. They shipped 88 Deep TMS systems, a 35% increase y-o-y, with total installed base at 1,522 systems. Recurring revenue streams from multiyear lease agreements make up approximately 70% of customer engagement, and the backlog of signed agreements with remaining performance obligation is approximately $62 million.

• Raised full-year 2025 revenue guidance to $50 million to $52 million, representing 22% to 27% growth over 2024 revenue.
• Expect operating profit in the range of 4% to 5% of revenue.
• Anticipate adjusted EBITDA in the range of 12% to 13% for the year.

• Shifts in market conditions due to geopolitical, supply chain, and other factors.
• Use of non-GAAP financial measures.
• Risks associated with regulatory approvals and reimbursement for new indications.

Q: Could you talk about the accelerated protocol in terms of timing to market, commercialization, and reimbursement?

A: Submitted data to FDA, expecting FDA answer by Q4 2025, aiming for clearance by end of year; commercialization to make treatment more convenient for patients; actively working on reimbursement to improve for the new protocol.

Q: Could you talk about the FTEs and size of the commercial organization?

A: Current sales team is around 16 direct sales folks, with 10 FTE practice development folks, overall 26 people supporting sales activity.

Q: Any updates on TMS 360 and the pilot study?

A: Plan to launch TMS 360 with alcohol use disorder trial by end of September, and do feasibility studies on neurology indications like cognitive behavior and Parkinson's before end of year.

Q: About the backlog, could you elaborate on enterprise customers? And OCD placements during the quarter?

A: Most backlog from enterprise customers; shipped 30 OCD systems during the quarter.

Q: How many strategic financing arrangements planned this year, capital outlay, and max cap?

A: Planning to sign at least 5 contracts before end of 2025, size of minority investment could range $2M to $5M; hope to sign 5 new agreements by end of 2025.

Q: Qualitative talk about Stella financing arrangement working out?

A: Collaboration with Stella MSO has seen over 50% increase in utilization of TMS patients at their clinics, with emphasis on educating and training centers.