Core Viewpoint - BrainsWay Ltd. has launched a multicenter clinical trial to evaluate its next-generation Deep TMS 360™ technology for treating Alcohol Use Disorder (AUD), which affects approximately 29 million Americans and has a high relapse rate among patients [1][3]. Group 1: Clinical Trial Details - The trial will be randomized, double-blind, and sham-controlled, enrolling over 200 patients aged 18–86 with moderate to severe AUD based on DSM-5 criteria [3]. - Participants will receive either active or sham treatments for about six months, with an intensive treatment phase in the first 3–5 weeks, followed by weekly maintenance sessions [3]. - The primary endpoint is the proportion of participants with no heavy drinking days during the initial four-month treatment period, a measure recognized by the FDA as clinically meaningful [3]. Group 2: Technology Overview - The new Deep TMS 360 technology is designed for more comprehensive and uniform stimulation of targeted brain regions, potentially addressing challenges in treating complex clinical populations like those with chronic AUD [2]. - The multichannel architecture of the system may enhance stimulation levels, particularly in patients with cortical atrophy [2][4]. Group 3: Company Perspective - The CEO of BrainsWay emphasized the significance of this trial in addressing a major public health challenge and the potential of the new technology to aid patients in overcoming alcohol dependence [3]. - The Vice President of Medical Affairs highlighted the study's potential to advance understanding of noninvasive neuromodulation in reducing alcohol cravings and promoting long-term recovery [4]. Group 4: Research Locations - The study will be conducted at multiple research sites across the US, including states like Alabama, California, Florida, Illinois, New York, and West Virginia, as well as select international sites in Israel and Sweden [4].

Core Insights - The FDA has granted a label expansion for BrainsWay's Deep TMS™ system, making it the first and only TMS device cleared for treating patients aged 15 to 86 suffering from major depressive disorder (MDD) [1][2][3] - This clearance allows access to Deep TMS™ for adolescents aged 15 to 21, a demographic often underserved by traditional pharmacological treatments [2][3] - The approval was supported by a substantial dataset from 1,120 adolescents treated across 35 TMS centers in the U.S., demonstrating a 66.1% response rate and an average improvement of 12.1 points on the PHQ-9 scale after 36 treatment sessions [2][3] Company Overview - BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, with a proprietary Deep TMS™ platform technology [4] - The company has obtained three FDA-cleared indications, including MDD, obsessive-compulsive disorder, and smoking addiction, backed by pivotal clinical studies [4] - BrainsWay aims to increase global awareness and access to Deep TMS, with ongoing clinical trials for various psychiatric, neurological, and addiction disorders [4] Market Impact - Approximately 5 million adolescents in the U.S. are estimated to have experienced a major depressive episode in the past year, highlighting the significance of this clearance for addressing an important segment of the MDD patient population [3] - The Deep TMS™ system is now indicated for both adults and adolescents, allowing clinicians to use the same system and established protocols for treatment [3] - MDD is a leading cause of disability globally, with a critical gap in accessible and effective therapies for patients who do not respond to traditional treatments [3]

Financial Performance - Revenue increased 29% to $13.5 million in Q3 2025 compared to Q3 2024[5] - Operating income totaled $1.3 million in Q3 2025, up from $0.3 million in the prior year period[5] - Adjusted EBITDA rose approximately 81% to $2.0 million in Q3 2025, compared to $1.1 million for Q3 2024[5] - Net profit for Q3 2025 increased 137% to $1.6 million, compared to $0.7 million for Q3 2024[5] - Revenues for Q3 2025 reached $13,512 thousand, a 28.6% increase from $10,502 thousand in Q3 2024[23] - Operating profit for Q3 2025 was $1,253 thousand, compared to $281 thousand in Q3 2024, marking a significant increase of 345.5%[23] - Net profit for the nine months ended September 30, 2025, was $4,700 thousand, a 242.5% increase from $1,373 thousand in the same period of 2024[23] - Adjusted EBITDA for Q3 2025 was $2,021 thousand, up 80.9% from $1,117 thousand in Q3 2024[28] - Basic net income per share for Q3 2025 was $0.04, doubling from $0.02 in Q3 2024[23] Operational Highlights - Remaining performance obligations increased to $65 million from customers under multi-year contracts[5] - Gross margin for Q3 2025 was 75%, compared to 74% in the prior year period[5] - Shipped a net total of 90 Deep TMS™ systems in Q3 2025, a 43% increase compared to the same period last year[5] Guidance and Investments - Full-year 2025 revenue guidance raised to $51 million – $52 million, up from previous guidance of $50 million – $52 million[5] - Announced four new minority equity investments in 2025 to expand strategic presence across the mental health treatment ecosystem[5] Cash and Expenses - Cash and cash equivalents at the end of Q3 2025 were $70,458 thousand, compared to $48,127 thousand at the end of Q3 2024, reflecting a 46.4% increase[26] - Total operating expenses for the nine months ended September 30, 2025, were $25,861 thousand, up 22.5% from $21,110 thousand in 2024[23] - Research and development expenses for the nine months ended September 30, 2025, totaled $7,072 thousand, an increase of 37.4% from $5,146 thousand in 2024[23] - Finance income for the nine months ended September 30, 2025, was $4,540 thousand, compared to $1,945 thousand in the same period of 2024, representing a 133.5% increase[23]

Core Insights - SoftBank Group has sold $5.8 billion worth of Nvidia stock to invest in OpenAI, indicating a strategic shift rather than a retreat from AI investments [1][4] - Nvidia has become a key player in the AI boom, with its stock price increasing over 10 times since the launch of ChatGPT [3] - SoftBank's decision reflects a belief that the potential value of OpenAI's developments will surpass the value of Nvidia's hardware [5][11] Company Actions - SoftBank has already invested $7.5 billion in OpenAI and plans to invest an additional $22.5 billion soon [4] - The sale of Nvidia shares has led to a nearly 3% decline in Nvidia's stock price [4] Market Context - The relationship between OpenAI and Nvidia has been significant, with Nvidia's chips being essential for AI development [2][3] - The move by SoftBank is seen as part of a broader trend where major investors are willing to divest from established stocks to pursue emerging opportunities [11] Historical Perspective - SoftBank's founder, Masayoshi Son, has a history of making bold investment decisions, including a previous investment in Nvidia that he later regretted missing out on [9][10]

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]

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, with adjusted EBITDA rising to $2 million from $1.1 million [16][18] - The company ended the quarter with $70.7 million in cash and cash equivalents, an increase of $1.1 million from the previous year [17] Business Line Data and Key Metrics Changes - The company shipped 90 deep TMS systems during the quarter, representing a 43% increase year-over-year, bringing the total install base to over 1,600 systems [5][15] - Approximately 70% of recent customer engagements were structured as lease agreements, indicating a strong transition to this sales model [6][7] 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 is seeing strong demand momentum, reflected in a book-to-bill ratio of 1.3x for the quarter [8] 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] - Recent FDA approval for an accelerated treatment protocol for major depressive disorder (MDD) is expected to enhance the appeal of deep TMS to prospective patients [10] - The company is pursuing minority equity investments in mental health providers to generate shareholder value and expand market awareness [12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, citing strong execution of the business model and improved visibility into the remainder of the year [5][6] - The company raised its revenue guidance for the full year 2025 to a range of $51 to $52 million, reflecting a year-over-year growth rate of 24% to 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 [14] - The company remains debt-free, providing significant flexibility for strategic growth initiatives [17] Q&A Session Summary Question: Can you discuss the accelerated protocol and its current treatments? - The accelerated protocol shortens the acute phase from four weeks to six days, increasing treatment frequency to five sessions per day, which is driving demand for the company's growth [21] Question: What can be expected regarding minority equity investments? - The company has a pipeline of minority investments and aims to sign at least one more by the end of the year, with promising opportunities for 2026 [22] Question: Update on NeuroLife's activities in Japan and the EU? - The company anticipates FDA clearance for NeuroLife's device by the end of the year, which will enable distribution through various channels [23] Question: Insights on system placements from minority partners? - Minority investments are expected to lead to the opening of 10 to 15 new clinics annually, with early investments showing over 50% growth in utilization rates [28][29] Question: Plans for altering metrics reporting? - The company plans to provide more granularity on metrics, including system shipments and performance of minority investments, during the analyst day [35] Question: State of international business and growth expectations? - The company expects strong growth from Asia-Pacific and Europe, particularly in Japan, China, and major European markets [36][37]

Advanced Noninvasive Neurostimulation Treatments for Mental Health Disorders Investor Deck November 2025 Nasdaq/TASE: BWAY Investor Deck | November 2025 Safe Harbor and Non-GAAP/IFRS Financial Measures This presentation does not constitute an offer orinvitation to sell orissue, or any solicitation of an offerto subscribe for or acquire, any securities ofthe Company, norto participate in any investment. This presentation shall not constitute advertising or be construed as commercial or promotional in nature. ...

Core Insights - BrainsWay Ltd. reported a 29% increase in revenue to $13.5 million for Q3 2025 compared to Q3 2024, with significant growth in operating income and adjusted EBITDA [1][5][18] - The company received FDA clearance for an accelerated protocol for Deep TMS treatment of major depressive disorder, enhancing its market position [1][5] - BrainsWay raised its full-year 2025 revenue and EBITDA guidance, reflecting strong operational performance and market dynamics [1][5][6] Financial Performance - Revenue for Q3 2025 was $13.5 million, a 29% increase from $10.5 million in Q3 2024 [1][5][18] - Operating income reached $1.3 million, up from $0.3 million in the prior year [1][5][18] - Adjusted EBITDA rose approximately 81% to $2.0 million compared to $1.1 million in Q3 2024 [1][5][18] - Net profit increased 137% to $1.6 million from $0.7 million in Q3 2024 [1][5][18] - Gross margin improved to 75% from 74% year-over-year [1][5] Operational Highlights - Remaining performance obligations increased to $65 million, with approximately 70% of recent customer engagements structured as multi-year lease agreements [1][5] - The company shipped 90 Deep TMS systems in Q3 2025, a 43% increase from the same period last year, bringing the total installed base to over 1,600 systems [1][5] - BrainsWay announced four new minority equity investments in 2025, expanding its strategic presence in the mental health treatment ecosystem [1][5][6] Guidance and Future Outlook - The company raised its full-year 2025 revenue guidance to $51 million – $52 million, up from the previous range of $50 million – $52 million [1][5] - Operating income guidance was increased to 6% – 7%, up from 4% – 5% [1][5] - Adjusted EBITDA guidance was raised to 13% – 14%, up from 12% – 13% [1][5] - CEO Hadar Levy highlighted significant opportunities for growth through new therapeutic indications and strategic collaborations [1][6][7]

Core Points - The U.S. National Institutes of Health (NIH) has awarded BrainsWay Ltd. a grant of approximately $2.5 million over five years for a clinical study on the efficacy of an accelerated Deep Transcranial Magnetic Stimulation (Deep TMS™) protocol for treating Alcohol Use Disorder (AUD) [1][2] - The study aims to evaluate the mechanism of action and potential efficacy of the treatment, utilizing BrainsWay's H7 Coil to target brain regions associated with addiction and relapse risk [2][3] - This grant marks the second major NIH funding awarded to the research team in two years, highlighting their leadership in neuromodulation for addiction [3] Research Details - The study will involve 100 adults with AUD in a randomized, double-blind, sham-controlled trial, with participants receiving three Deep TMS treatments per day for 10 consecutive business days, totaling 30 treatment sessions [6] - Neuroimaging assessments will be used to investigate neural activation in targeted brain regions, linking clinical outcomes such as days abstinent and heavy drinking days to observed brain changes [6] Company Background - BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, with a proprietary Deep TMS™ platform technology [5] - The company has received FDA clearance for multiple indications, including major depressive disorder, obsessive-compulsive disorder, and smoking addiction, demonstrating clinically proven efficacy [5] - Recent developments include FDA clearance for the H1 Coil for accelerated treatment of major depressive disorder, indicating ongoing innovation in treatment protocols [4]