Financial Data and Key Metrics Changes - The company reported record quarterly revenue of $13.5 million for Q3 2025, a 29% increase compared to $10.5 million in the same period last year [5][15] - Gross profit for the quarter was $10.2 million, up from $7.7 million in the prior year, maintaining a gross margin of 75% [16] - Operating profit was approximately $1.3 million, a significant increase from $0.3 million reported in the same period last year [16] - Adjusted EBITDA increased to $2 million from $1.1 million in the prior year [16] - The company raised its revenue guidance for the full year 2025 to a range of $51 million-$52 million, up from the previous guidance of $50 million-$52 million [5][18] Business Line Data and Key Metrics Changes - The company shipped 90 deep TMS systems during the quarter, representing a 43% increase compared to the same period last year, bringing the total install base to over 1,600 systems globally [5][15] - Approximately 70% of recent customer engagements were structured as multi-year lease agreements, indicating a strong transition to this sales model [8] Market Data and Key Metrics Changes - Remaining performance obligations under existing customer agreements grew to $65 million, a 37% year-over-year increase, providing strong visibility into future revenues [17] - The company noted strong demand momentum in various international markets, particularly in Asia-Pacific and Europe, with expectations for significant growth in countries like Japan, China, and South Korea [36][38] Company Strategy and Development Direction - The company focuses on three key pillars for long-term growth: elevating market awareness of Deep TMS, advancing the R&D roadmap, and broadening patient access through global extension and health system integration [9] - The recent FDA approval for an accelerated treatment protocol for major depressive disorder is expected to enhance the appeal of Deep TMS to prospective patients [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, citing a solid book-to-bill ratio of 1.3x and high customer retention rates [8] - The company anticipates further investments in minority interests in mental health providers to enhance market awareness and expand access to Deep TMS [12][14] Other Important Information - The company ended the quarter with $70.7 million in cash and cash equivalents, reflecting strong collection efficiency despite deploying $7.3 million for minority equity investments [17] - A virtual investor and analyst day is scheduled for December 1 to discuss operational, clinical, regulatory, and financial progress in more detail [15] Q&A Session Summary Question: Can you discuss the accelerated protocol and its current treatments? - Management highlighted that the accelerated protocol shortens the acute phase from four weeks to six days, increasing treatment frequency, which is driving demand for growth [20] Question: What can be expected regarding minority equity investments? - Management indicated a robust pipeline for minority investments, aiming to sign at least one more agreement by year-end, with promising opportunities for 2026 [21] Question: Any updates on Neurolief's activities in Japan and the EU? - Management anticipates FDA clearance for Neurolief by year-end, which would enable marketing and distribution through various channels [22] Question: What are the expectations for system placements from minority partners? - Each minority investment is expected to open 10-15 new clinics annually, with early investments showing over 50% growth in utilization rates [28][29] Question: Will there be changes in metrics reporting going forward? - Management plans to provide more granularity on metrics such as system shipments and performance of minority investments during the analyst day [35] Question: What is the outlook for international growth? - Management expects strong growth in Asia-Pacific and Europe, particularly in Japan, China, and major European countries [36][38]

Financial Data and Key Metrics Changes - The company reported record quarterly revenue of $13.5 million for Q3 2025, a 29% increase compared to $10.5 million in the same period last year [5][15] - Gross profit for the quarter was $10.2 million, up from $7.7 million in the prior year, maintaining a gross margin of 75% [16] - Operating profit increased to approximately $1.3 million from $0.3 million year-over-year [16] - Adjusted EBITDA rose to $2 million from $1.1 million in the prior year [16] - The company ended the quarter with $70.7 million in cash and cash equivalents, an increase of $1.1 million from the end of 2024 [17] - Remaining performance obligations grew to $65 million, a 37% year-over-year increase [17] Business Line Data and Key Metrics Changes - The company shipped 90 Deep TMS systems during the quarter, representing a 43% increase compared to the same period last year, bringing the total install base to over 1,600 systems globally [5][15] - Approximately 70% of recent customer engagements were structured as multi-year lease agreements, indicating a strong transition to this sales model [8] Market Data and Key Metrics Changes - The company is focusing on expanding its market presence, particularly in Asia-Pacific and Europe, with strong demand anticipated from countries like Japan, China, South Korea, and India [36][38] - The company has received FDA clearance for an accelerated treatment protocol for major depressive disorder, which is expected to enhance patient appeal and drive demand [10] Company Strategy and Development Direction - The company’s strategy includes elevating market awareness of Deep TMS, advancing its R&D roadmap, and broadening patient access through global extension and health system integration [9] - The company is pursuing minority equity investments in mental health providers to enhance market awareness and expand access to Deep TMS [12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company’s growth trajectory, citing strong market demand and a solid book-to-bill ratio of 1.3x for the quarter [8] - The company raised its revenue guidance for the full year 2025 to a range of $51 million-$52 million, reflecting a year-over-year growth rate of 24%-27% [18] Other Important Information - The company announced a virtual investor and analyst day on December 1 to discuss operational, clinical, regulatory, and financial progress in more detail [14] Q&A Session Summary Question: Can you discuss the accelerated protocol and its current treatments? - Management highlighted that the accelerated protocol shortens the acute phase from four weeks to six days, increasing treatment frequency, which is driving demand for growth [20] Question: What can be expected regarding minority equity investments? - Management indicated a robust pipeline for minority investments, aiming to sign at least one more agreement by year-end, with promising opportunities for 2026 [21] Question: Any updates on Neurolief's activities in Japan and the EU? - Management anticipates FDA clearance for Neurolief by year-end, which will enable marketing and distribution through various channels [22] Question: What are the expectations for system placements from minority partners? - Management noted that minority investments are expected to lead to the opening of 10-15 new clinics annually, with early investments showing over 50% utilization growth [28][29] Question: Will there be changes in metrics reporting going forward? - Management plans to provide more granularity on metrics such as system shipments and performance of minority investments during the analyst day [35] Question: What is the outlook for international growth? - Management expects strong growth from Asia-Pacific and Europe, with increasing demand in countries like Japan, China, and Germany [36][38]

BrainsWay (BWAY) Q1 2025 Earnings Call May 13, 2025 08:30 AM ET Company Participants Brian Ritchie - Managing DirectorHadar Levy - Chief Executive OfficerIdo Marom - Chief Financial OfficerDestiny Hance - Associate Director of ResearchEduardo Martinez-Montes - Biotechnology Equity Research Associate Conference Call Participants Steven Lichtman - MD & Senior Analyst - Medical Devices Operator Good day, and welcome to the BrainsWay First Quarter twenty twenty five Earnings Conference Call. All participants wi ...

Financial Data and Key Metrics Changes - The company generated $11,500,000 in revenue for Q1 2025, a 27% increase year over year from $9,100,000 in Q1 2024 [4][15] - Gross profit for Q1 2025 was $8,600,000, maintaining a gross margin of 75%, compared to $6,800,000 in the prior year [16] - Operating profit for Q1 2025 was approximately $576,000, up from approximately $93,000 in the same period of 2024 [17] - Adjusted EBITDA for Q1 2025 was about $1,300,000, representing the seventh consecutive quarter of positive adjusted EBITDA, compared to $715,000 in Q1 2024 [17] - The company reported a net profit of about $1,100,000 for Q1 2025, compared to $111,000 in Q1 2024 [18] - Cash, cash equivalents, and short-term deposits totaled approximately $72,000,000 as of March 31, 2025 [18] Business Line Data and Key Metrics Changes - The company shipped a total of 81 Deep TMS systems in Q1 2025, representing a 42% increase compared to Q1 2024 [4] - The installed base of Deep TMS systems increased to 1,434 as of March 31, 2025, compared to 1,158 systems at the same point in the prior year [15] Market Data and Key Metrics Changes - The backlog and remaining performance obligation totaled nearly $60,000,000, providing visibility into future growth [5] - The U.S. market is driving commercial growth, particularly in the treatment of obsessive-compulsive disorder (OCD) and anxious depression [5] Company Strategy and Development Direction - The growth strategy focuses on three key pillars: elevating market awareness of Deep TMS, advancing the R&D roadmap for new treatment indications, and broadening patient access through global expansion [7] - The company aims to ramp up activity around OCD in 2025, with over 60% of patients responding positively to Deep TMS therapy [9] - The company is also working to expand reimbursement for PTSD treatment in Israel and is advancing clinical trials for an accelerated treatment protocol for major depressive disorder [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the positive operating environment and reiterated full-year 2025 financial guidance of $49,000,000 to $51,000,000 in revenue, representing 20% to 24% growth over 2024 [14][19] - The company does not anticipate a material impact on gross margin from recent international trade and tariff policies [14] Other Important Information - The company is actively monitoring geopolitical risks and tariff policies but does not foresee significant negative impacts on its operations [37] - The company is evaluating the implementation of a stock repurchase program but is currently focused on expanding growth and investing in innovation [41] Q&A Session Summary Question: What is the breakdown of new sales between market expansion and competitive conversions? - Management indicated that approximately 80% of new sales are from greenfield opportunities, while 20% are competitive conversions [21] Question: Can you elaborate on the pay-per-use model? - The pay-per-use model is being implemented in specific segments, providing systems without upfront fees and charging per procedure, which offers flexibility for providers [23] Question: When can we expect data from the accelerated protocol clinical trials? - The company expects to receive FDA clearance for the accelerated protocol data by the end of the year and is also working on data collection for PTSD treatment [25][26] Question: How many OCD helmets were shipped during the quarter? - The company shipped 57 OCD helmets, bringing the total installed base to approximately 850 globally [29] Question: Are there significant geopolitical risks affecting the business? - Management does not see significant geopolitical risks impacting the business at this time, although they are actively monitoring the situation [37] Question: Will there be more upgrades to the current installed base this year or in 2026? - Management expects continued demand growth for Deep TMS systems, indicating a healthy demand for upgrades [39] Question: Is the company considering a stock repurchase program? - Currently, the company is not considering a stock repurchase program, focusing instead on growth and innovation investments [41]