Key Takeaways BWAY benefits as Optum expands Deep TMS coverage to adolescents with major depressive disorder.BWAY sees a wider reimbursable teen patient base, driving earlier treatment adoption and utilization growth.BWAY gains from broader insurer alignment that improves revenue visibility and encourages clinic investment.BrainsWay Ltd. (BWAY) recently announced an expansion of insurance coverage for its Deep TMS therapy in adolescent depression. The update signals growing payer confidence in non-drug neur ...

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]

Financial Data and Key Metrics Changes - The company reported record quarterly revenue of $12,600,000 for Q2 2025, representing a 26% increase compared to $10,000,000 in the same period last year [4][12] - Gross profit for the quarter was $9,500,000, up from $7,500,000 in the prior year, maintaining a strong gross margin of 75% [12][13] - Net profit for the quarter was $2,000,000 compared to $600,000 in the same period of 2024 [14] - Remaining performance obligation grew to $62,000,000, a 25% year-over-year increase, providing strong visibility into future revenue [16] Business Line Data and Key Metrics Changes - The company shipped a total of 88 Deep TMS systems during the quarter, representing a 35% increase compared to the same period last year [4][5] - The total installed base reached 1,522 systems as of June 30, 2025, compared to 1,215 systems a year ago [12] Market Data and Key Metrics Changes - The company has focused on generating recurring revenue streams through multiyear lease agreements, which now account for approximately 70% of recent customer engagements [5] - The backlog of signed agreements with remaining performance obligations totaled approximately $62,000,000, indicating strong future revenue visibility [5][16] Company Strategy and Development Direction - The company aims to elevate market awareness of Deep TMS, advance its R&D roadmap, and broaden patient access through global expansion and health system integration [6] - A new initiative to generate shareholder value through minority interest investments in mental health providers was identified, with a strategic equity investment of $20,000,000 from Valo Equity Partner [10][11] - The company plans to sign at least five contracts for strategic financing arrangements by the end of the year, with a goal of 10 contracts by 2026 [37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the accelerated treatment protocol for Deep TMS, expecting FDA clearance by Q4 2025, which could significantly enhance patient convenience [20][21] - The company raised its full-year 2025 revenue guidance to a range of $50,000,000 to $52,000,000, representing 22% to 27% growth over 2024 revenue [17] Other Important Information - The company has engaged in educational initiatives to enhance clinician knowledge and confidence in Deep TMS, including funding new continuing medical education courses [7][8] - Cash position at the end of the quarter was $78,300,000, up $30,200,000 from the same point last year, reflecting strong collections and strategic investments [14][15] Q&A Session Summary Question: Can you discuss the accelerated protocol and its market potential? - Management expects to receive FDA feedback on the accelerated protocol by Q4 2025, which could reduce treatment time significantly, making it more appealing to patients [20][21] Question: What is the size of the commercial organization and its growth? - The current sales team consists of 16 direct sales personnel and 10 practice development staff, totaling 26 individuals supporting sales activities [25] Question: What is the status of the TMS 360 and pilot studies? - The TMS 360 is planned for launch with an alcohol use disorder trial in Q3 2025, alongside feasibility studies for other indications [27] Question: What is the composition of the backlog and OCD placements? - The majority of the backlog comes from enterprise customers, with 30 OCD systems shipped in the second quarter [32] Question: How many strategic financing arrangements are planned for this year? - The company aims to sign at least five new contracts for strategic investments by the end of the year, with potential investments ranging from $2,000,000 to $5,000,000 [36][37] Question: How has the Stella financing arrangement been performing? - The collaboration with Stella MSO has resulted in over a 50% increase in TMS patient utilization, demonstrating the effectiveness of the partnership [38]