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]

Core Insights - BrainsWay Ltd. will report its Q3 2025 financial results and operational highlights on November 11, 2025, before the U.S. market opens [1] - A conference call and webcast will be held at 8:30 AM Eastern Time to discuss the results and provide business updates [2] Company Overview - BrainsWay is a leader in noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology [3] - The company has received FDA clearance for three indications: major depressive disorder, obsessive-compulsive disorder, and smoking addiction, supported by pivotal clinical studies [3] - Founded in 2003, BrainsWay operates in the U.S. and Israel, focusing on increasing awareness and access to Deep TMS [3]

Core Viewpoint - BrainsWay Ltd. has made two additional strategic minority stake investments in U.S. mental health providers, bringing the total to four in 2025, aiming to enhance patient access to innovative mental health treatments and drive long-term shareholder value [1][2][5] Investment Details - BrainsWay will invest an initial $1.5 million in Heading Health, with the potential for an additional $2.5 million through three milestone-based investments [3] - The investment in Heading Health will provide BrainsWay with a minority position in the form of a preferred, annually compounding security [3] Strategic Intent - The investment strategy is designed to facilitate the growth of commercial partners while allowing BrainsWay to maintain its focus on scientific and technological advancements [4] - The partnership with Heading Health is seen as a unique opportunity to expand treatment options and improve patient lives on a large scale [5] Company Overview - BrainsWay is a leader in noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology [6] - The company has received FDA clearance for three indications, including major depressive disorder, obsessive-compulsive disorder, and smoking addiction [6] Heading Health Overview - Heading Health specializes in interventional psychiatry, focusing on effective mental health protocols for conditions such as severe trauma, stress, anxiety, and depression [7] - The organization employs a team of board-certified psychiatrists and advanced psychiatric nurse practitioners to deliver cutting-edge treatment options [7]

Group 1 - Alkermes (ALKS) is currently outperforming its peers in the Medical sector with a year-to-date return of 7.7%, compared to the sector average of 1.7% [4] - The Zacks Rank for Alkermes is 2 (Buy), indicating a positive outlook based on earnings estimates and revisions, with a 15.4% increase in the consensus estimate for full-year earnings over the past 90 days [3] - Alkermes is part of the Medical - Biomedical and Genetics industry, which has seen a year-to-date gain of 10.6%, indicating that ALKS is slightly underperforming its industry [6] Group 2 - The Medical group consists of 956 companies and is currently ranked 4 in the Zacks Sector Rank, which evaluates 16 different sector groups [2] - Another stock in the Medical sector, Brainsway Ltd. Sponsored ADR (BWAY), has significantly outperformed with a year-to-date increase of 68.4% and also holds a Zacks Rank of 2 (Buy) [4][5] - The Medical - Products industry, which includes Brainsway, has a lower ranking at 95 and has gained 5.3% since the beginning of the year [7]

Core Insights - BrainsWay Ltd. (BWAY) has received FDA clearance for an accelerated treatment protocol using its Deep Transcranial Magnetic Stimulation (TMS) system for major depressive disorder, enhancing patient access and provider flexibility [1][4] - The new protocol requires fewer visits while showing comparable outcomes to the standard approach, which may facilitate stronger adoption in the mental health market [2][11] - Following the announcement, BWAY's shares increased by 11.9%, with a year-to-date gain of 79.2%, significantly outperforming the industry and S&P 500 [3] Company Developments - The accelerated Deep TMS protocol reduces treatment time to six days with five sessions per day, compared to the traditional four-week regimen, making it more convenient for patients [9] - Clinical trials demonstrated that the accelerated protocol achieved similar depression score reductions and remission rates as the standard method, with no severe adverse events reported [10][11] - BWAY is actively preparing provider training and reimbursement updates to support the wider adoption of the new treatment protocol [2][11] Market Position and Growth Potential - The FDA clearance positions BWAY to capture a larger share of the mental health market by offering a faster treatment option, potentially driving revenue growth and enhancing competitive differentiation [4][11] - BWAY has a market capitalization of $285.3 million and projects an earnings growth of 94.4% for the current year [5] - The global neuromodulation devices market is projected to grow from $5.80 billion in 2024 to $10.39 billion by 2030, with a CAGR of 8.51%, indicating favorable industry prospects for BWAY [12]

Core Viewpoint - BrainsWay has received FDA clearance for an accelerated treatment protocol for its Deep TMS system, which is expected to enhance patient access and treatment efficacy for major depressive disorder (MDD) [1][2][3] Group 1: FDA Clearance and Treatment Protocol - The FDA has expanded the treatment protocols for BrainsWay's Deep TMS system to include an accelerated protocol for MDD, which is now commercially available in the U.S. [1] - The new accelerated protocol reduces the treatment duration from 4 weeks to just 6 days of acute treatment, allowing for quicker patient response [2][3] - The accelerated protocol consists of 5 sessions per day for 6 days, followed by 2 sessions per week for 4 weeks, with each session lasting less than 10 minutes [3] Group 2: Clinical Study Results - Clinical data from a multicenter, randomized, controlled study showed that the accelerated protocol resulted in comparable outcomes to the standard protocol, with HDRS-21 depression scores reduced by 19.02 points in the accelerated group and 19.79 points in the standard group [3] - Response and remission rates for the accelerated group were 87.8% and 78.0%, respectively, compared to 87.5% and 87.5% for the standard group [3] - The median time to remission was 21 days for the accelerated group, compared to 28 days for the standard group, indicating a faster therapeutic effect [3] Group 3: Market Context and Company Overview - MDD is a leading cause of disability globally, affecting millions and creating a critical gap in accessible and effective therapies, particularly for patients who do not respond to traditional treatments [4] - BrainsWay is a leader in noninvasive neurostimulation treatments, with its Deep TMS platform being the first to receive three FDA-cleared indications backed by clinical studies [5] - The company is committed to advancing neuroscience and increasing global awareness and access to Deep TMS, with ongoing clinical trials for various psychiatric and neurological disorders [5][6]

Core Insights - BrainsWay Ltd. (BWAY) has made a strategic investment of $5 million in Neurolief Ltd., aiming to expand its presence in the mental health market, particularly in at-home treatment solutions [1][9][10] - Neurolief is developing Proliv Rx, a therapy targeting Major Depressive Disorder (MDD), which is a significant area of unmet medical need [2][11] - Following the investment announcement, BWAY's stock increased by 1.5%, and the company has seen a year-to-date stock surge of 59%, outperforming the industry and S&P 500 [3][5] Company Strategy - The investment allows BrainsWay to enter the at-home mental health treatment market, thereby expanding its total addressable market (TAM) beyond its existing Deep TMS platform [4][12] - By utilizing Neurolief's wearable neuromodulation technology, BrainsWay can diversify its revenue streams and enhance its competitive positioning in the treatment of depression [4][13] Financial Projections - BWAY currently has a market capitalization of $279.2 million and is projecting an earnings growth of 88.9% for the current year [5] - The investment includes future milestone-based funding, with potential additional investments contingent on FDA approval and revenue milestones for Neurolief [10] Industry Outlook - The global neuromodulation devices market is projected to grow from $5.80 billion in 2024 to $10.39 billion by 2030, with a compound annual growth rate (CAGR) of 8.51% from 2025 to 2030 [14] - The increasing prevalence of chronic pain, neurological disorders, and mental health conditions is expected to drive demand for innovative treatment solutions [14]