Financial Data and Key Metrics Changes - The company generated 9,100,000 in Q1 2024 [4][15] - Gross profit for Q1 2025 was 6,800,000 in the prior year [16] - Operating profit for Q1 2025 was approximately 93,000 in the same period of 2024 [17] - Adjusted EBITDA for Q1 2025 was about 715,000 in Q1 2024 [17] - The company reported a net profit of about 111,000 in Q1 2024 [18] - Cash, cash equivalents, and short-term deposits totaled approximately 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 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]
Brainsway(BWAY) - 2025 Q1 - Earnings Call Transcript