Core Insights - BrainsWay Ltd. is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, showcasing its Deep TMS technology at the Clinical TMS Society's 2025 Annual Meeting [1][4] - The company will present preliminary results from a multicenter randomized non-inferiority trial comparing its standard Deep TMS protocol to a novel accelerated protocol [2] - BrainsWay is the first and only TMS company to obtain three FDA-cleared indications, including major depressive disorder, obsessive-compulsive disorder, and smoking addiction [4] Company Overview - BrainsWay was founded in 2003 and operates in the United States and Israel, focusing on improving health through its proprietary Deep TMS platform technology [4] - The company is dedicated to advancing neuroscience and increasing global awareness and access to Deep TMS treatments [4] Clinical Research Highlights - The latest Deep TMS research will be featured in poster presentations at the conference, emphasizing the technology's advantages over first-generation TMS systems [3] - A Phase IV Registry Study demonstrated that 49% of patients successfully quit smoking after 15 treatment sessions using the Deep TMS H4 Coil [5] - A post-marketing surveillance study involving over 1,200 adolescent patients showed the efficacy and safety of Deep TMS for adolescent depression [5]

Core Viewpoint - Brainsway Ltd. (BWAY) has shown a significant price increase of 20.1% over the past four weeks, with a mean price target of $15.05 indicating a potential upside of 43.9% from its current price of $10.46 [1] Price Targets and Analyst Estimates - The mean estimate consists of four short-term price targets with a standard deviation of $0.74, where the lowest estimate is $14.20 (35.8% increase) and the highest is $16 (53% increase) [2] - A low standard deviation suggests a strong agreement among analysts regarding the stock's price movement, which can be a useful starting point for further research [9] Earnings Estimates and Analyst Sentiment - Analysts have shown increasing optimism about BWAY's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which correlates with potential stock price movements [11] - Over the last 30 days, three earnings estimates have been revised higher, resulting in a 13% increase in the Zacks Consensus Estimate [12] Zacks Rank and Investment Potential - BWAY holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside in the near term [13]

Core Insights - BrainsWay has entered into a strategic equity financing agreement with Stella MSO, LLC to enhance access to mental health care and raise awareness of innovative treatments [1][2] - The investment in Stella is part of a broader strategy to make minority-stake investments in high-performing mental health providers across the U.S. [2] - BrainsWay will invest $5 million in Stella, acquiring a minority position in the company through preferred, annually compounding securities [4] Company Overview - BrainsWay is a leader in noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology [5] - The company has received FDA clearance for three indications: major depressive disorder, obsessive-compulsive disorder, and smoking addiction [5] - BrainsWay aims to increase global awareness and access to Deep TMS through ongoing clinical trials and scientific advancements [5] Stella Overview - Stella is an interventional psychiatry practice focused on effective mental health protocols for conditions such as severe trauma, stress, anxiety, and depression [6] - The organization has a strong reputation for clinical excellence and operational strength, having treated over 30,000 patients across more than 20 clinics [1][6] - Stella's partnership with BrainsWay is expected to accelerate its growth and enhance patient care [3][5]

Core Insights - BrainsWay Ltd. has entered into a strategic equity financing agreement with Stella MSO, LLC to enhance access to innovative mental health treatments [1][2] - The investment of $5 million will provide BrainsWay with a minority position in Stella, aimed at supporting the interventional psychiatry space [4][2] - This partnership is expected to accelerate growth and improve patient care through Stella's established network of mental health clinics [3][5] Company Overview - BrainsWay is a leader in noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep TMS™ technology [5] - The company has received FDA clearance for three indications: major depressive disorder, obsessive-compulsive disorder, and smoking addiction [5] - BrainsWay is focused on advancing neuroscience and increasing global awareness of its treatment options [5] Stella Overview - Stella is an interventional psychiatry practice that addresses severe trauma, stress, anxiety, and depression through a multidisciplinary approach [6] - The organization has a strong reputation for clinical excellence and operational strength, having treated over 30,000 patients [1][6] - Stella aims to expand access to transformative mental health care through its network of clinics [3][5]

Group 1 - Brainsway Ltd. Sponsored ADR (BWAY) shows a significantly improving earnings outlook, making it a solid choice for investors [1] - Analysts are raising their earnings estimates for Brainsway, indicating a positive trend that may reflect in the stock price [2][3] - The Zacks Rank system, which ranges from 1 (Strong Buy) to 5 (Strong Sell), has a strong track record, with 1 ranked stocks averaging a +25% annual return since 2008 [3] Group 2 - For the current quarter, Brainsway is expected to earn $0.04 per share, with a 10% increase in consensus estimates over the last 30 days [5] - The full-year earnings estimate is $0.15 per share, reflecting a -16.67% change from the previous year, but the trend shows three estimates moving higher compared to one negative revision [6] - Brainsway currently holds a Zacks Rank 2 (Buy), indicating promising estimate revisions and potential for significant outperformance compared to the S&P 500 [7] Group 3 - The stock has increased by 23.4% over the past four weeks due to strong estimate revisions, suggesting further upside potential [8]

Core Viewpoint - Brainsway Ltd. (BWAY) has shown a significant price increase of 35.5% over the past four weeks, with analysts projecting further upside potential based on a mean price target of $15.05, indicating a 41.3% increase from the current price of $10.65 [1] Price Targets and Analyst Estimates - The mean price target consists of four short-term estimates with a standard deviation of $0.74, where the lowest estimate is $14.20 (33.3% increase) and the highest is $16 (50.2% increase) [2] - A low standard deviation among price targets suggests a strong consensus among analysts regarding the stock's price direction and magnitude [9] Earnings Estimates and Market Sentiment - Analysts have shown increasing optimism about BWAY's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which historically correlates with stock price movements [11] - The Zacks Consensus Estimate for the current year has risen by 11.1% over the past month, with two estimates increasing and one decreasing [12] - BWAY holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, suggesting strong potential for near-term upside [13]

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]

Core Insights - BrainsWay Ltd. achieved record quarterly sales of $11.5 million in Q1 2025, marking a 27% increase compared to Q1 2024 [1][8] - The company reported an operating profit of $0.6 million, a significant increase of 519% year-over-year, and Adjusted EBITDA rose to $1.3 million, up 81% from the previous year [1][8] - The demand for Deep TMS Systems is strong, with a record shipment of 81 systems in Q1 2025, representing a 42% increase from 57 systems shipped in the same period last year [1][8] Financial Performance - Revenue for Q1 2025 was $11.5 million, up 27% from $9.1 million in Q1 2024 [8][21] - Gross margin remained stable at 75% compared to the prior year [8] - Net profit surged by 897% to $1.1 million in Q1 2025, compared to $0.1 million in Q1 2024 [1][8] Operational Highlights - The company is reiterating its full-year 2025 financial guidance, projecting revenue between $49 million to $51 million, with an operating profit margin of 3% to 4% and Adjusted EBITDA of 11% to 12% [5][8] - BrainsWay's CEO highlighted the growing demand for their technology in treating various mental health disorders, including OCD and anxious depression, and emphasized the importance of relationships with large enterprise customers [5][6] Market Expansion - The company is expanding its global market presence, now operating in key markets including Canada, Asia, India, and Europe [6] - Upcoming catalysts for growth include the next-generation Deep TMS 360™ system and the expansion into new indications supported by additional clinical data [6]

Company Overview - BrainsWay Ltd. is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, specifically through its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology [4] - The company has obtained three FDA-cleared indications for Deep TMS, which include Major Depressive Disorder (MDD), Anxious Depression, Obsessive-Compulsive Disorder (OCD), and Smoking Addiction [4] - Founded in 2003, BrainsWay operates in both Israel and the U.S. and is committed to increasing global awareness and access to Deep TMS [4] Industry Participation - BrainsWay will participate in the American Psychiatric Association (APA) Annual Meeting from May 17–21, 2025, in Los Angeles, California, showcasing its role in psychiatric care [1] - The company will host live demonstrations of its Deep TMS system at its exhibit booth, providing hands-on interaction with this innovative treatment modality [3] Educational Initiatives - A master course titled "Clinical Applications for Psychiatric Practice: Ketamine and TMS" will be held on May 18, 2025, focusing on integrating novel treatments into clinical psychiatric practice [2] - The course will feature prominent clinician-researchers, including BrainsWay's Chief Medical Officer Dr. Richard Bermudes and Vice President of Medical Affairs Dr. Colleen Hanlon, discussing innovative therapeutic approaches [2][3]