Core Insights - BrainsWay reported strong financial performance for Q4 and full-year 2025, with significant increases in operating income, revenue, and adjusted EBITDA, indicating robust growth and momentum in its Deep TMS business [1][3][4] Financial Performance - Q4 operating income reached approximately $1.9 million, up from $0.4 million year-over-year, while full-year operating income was approximately $4.3 million compared to $1.4 million in 2024 [1] - Q4 gross profit was $11.1 million, an increase from $8.5 million a year earlier, with a gross margin of 76% compared to 75% in the prior-year quarter [2] - Q4 revenue increased by 27% year-over-year to $14.5 million, with full-year revenue also rising 27% to $52.2 million compared to 2024 [3][7] - Full-year adjusted EBITDA was $7.0 million, representing 13% of revenue, which was at the top end of the company's guidance [1][4] Business Model and Strategy - The company is transitioning to a recurring leasing model, which has driven strong demand, shipping 95 Deep TMS systems in Q4 and growing its installed base to approximately 1,700 systems, a 26% increase from the prior year [6][8] - Remaining performance obligations grew to $70 million, reflecting a 43% increase from $49 million a year earlier, indicating strong future revenue visibility [8] Regulatory and Clinical Developments - The FDA expanded the Deep TMS label to include adolescents aged 15–21 with major depressive disorder, enhancing market access [5][17] - The company received a $2.5 million NIH grant for a clinical trial evaluating Deep TMS for alcohol use disorder, with recruitment goals set for over 200 patients [5][12] - BrainsWay is also working on a feasibility study for Alzheimer's disease and preparing an FDA submission based on data from U.S. depression patients with comorbid PTSD symptoms [13] Future Outlook - For 2026, the company guided revenue of $66 million to $68 million, representing year-over-year growth of 27% to 30%, with adjusted EBITDA expected to be between $12 million and $14 million [5][19] - The company remains debt-free with $68 million in cash and cash equivalents at year-end 2025, indicating a strong financial position [19]

Financial Data and Key Metrics Changes - The company reported a 27% increase in revenue to $14.5 million for Q4 2025, with full-year revenue also growing 27% to $52.2 million compared to 2024 [4][18] - Gross profit for Q4 was $11.1 million, up from $8.5 million in the prior year, increasing gross margin to 76% [19] - Net income for Q4 was $2.9 million, compared to $1.5 million in the same period of 2024, with full-year net income of approximately $7.6 million compared to $2.9 million in 2024 [23] Business Line Data and Key Metrics Changes - The company shipped 95 Deep TMS systems during Q4, bringing the total installed base to approximately 1,700 systems, a 26% increase year-over-year [4][18] - The book-to-bill ratio improved to 1.4x from 1.2x in the previous quarter, indicating strong demand [5] - Remaining performance obligations reached $70 million, representing a 43% growth from $49 million a year ago [5][24] Market Data and Key Metrics Changes - The company has penetrated less than 10% of the market for Deep TMS, indicating significant growth potential [7] - The FDA granted label expansion for Deep TMS to treat adolescents aged 15 to 21 with major depressive disorder, expanding the addressable patient population [9][10] Company Strategy and Development Direction - The company is focusing on expanding reimbursement coverage with payers across the U.S. to support broader adoption of Deep TMS [8] - A strategic initiative is in place to secure minority equity investments in high-performing mental health providers, which is expected to facilitate faster access to interventional psychiatry modalities [14][15] - The long-term vision includes developing a portfolio of data-driven technology-enabled neuromodulation solutions to serve more patients [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the momentum in the business and expects revenue in the range of $66 million to $68 million for 2026, representing a year-over-year growth rate of 27%-30% [24] - The company anticipates adjusted EBITDA of $12 million to $14 million for 2026, indicating expected growth of 86%-100% over 2025 [25] Other Important Information - The company received a $2.5 million NIH grant for a study on Deep TMS for alcohol use disorder, highlighting ongoing clinical research efforts [12][13] - The SWIFT Deep TMS protocol was validated through peer-reviewed studies, which could significantly improve patient access and treatment efficiency [11] Q&A Session Summary Question: Can you give us a better sense of the fourth quarter placements as far as units sold, units leased, and also any color regarding OCD placements? - The company shipped 95 systems during Q4, with more than 50% including the H7 coils [26] Question: Can you talk about the Deep TMS 360 trial that's going on? - The TMS 360 trial is actively recruiting patients for alcohol use disorder in 10 centers across the U.S., aiming to recruit over 200 patients [28][29] Question: Was there any pricing change in 2025 or anticipated for 2026? - The company does not anticipate a decrease in average selling price and aims to optimize pricing based on the value provided [31] Question: What percentage of the $70 million obligations relates to commitments from existing strategic partners? - The minority investment program is expected to deliver new backlog or bookings of between $3-$5 million on a yearly basis from each center [35][36] Question: Do you anticipate significant utilization of the SWIFT protocol in conjunction with other therapies? - There is strong demand for TMS, particularly with the SWIFT protocol, which is being used alongside other modalities like psychedelics and medication management [41]

Financial Data and Key Metrics Changes - The company reported a 27% increase in revenue to $14.5 million for Q4 2025, with full-year revenue also growing 27% to $52.2 million compared to 2024 [4][18] - Gross profit for Q4 was $11.1 million, up from $8.5 million in the prior year, increasing gross margin to 76% [19] - Net income for Q4 was $2.9 million, compared to $1.5 million in the same period of 2024, with full-year net income of approximately $7.6 million compared to $2.9 million in 2024 [23] Business Line Data and Key Metrics Changes - A total of 95 Deep TMS systems were shipped during Q4, bringing the installed base to approximately 1,700 systems, a 26% increase year-over-year [4][18] - The book-to-bill ratio improved to 1.4x from 1.2x in the previous quarter, indicating strong demand [5] Market Data and Key Metrics Changes - Remaining performance obligations reached $70 million, representing a 43% growth from $49 million a year ago, reflecting strong demand and long-term commitments [5][24] - The company estimates it has penetrated less than 10% of the market for Deep TMS, indicating significant growth potential [7] Company Strategy and Development Direction - The company is focusing on expanding reimbursement coverage with payers across the U.S. to increase market share [8] - A strategic initiative is in place to secure minority equity investments in high-performing mental health providers, which is expected to facilitate faster access to interventional psychiatry modalities [14][15] - The company aims to develop a portfolio of data-driven technology-enabled neuromodulation solutions to serve more patients and settings [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the momentum in the business and expects revenue in the range of $66 million to $68 million for 2026, representing a year-over-year growth rate of 27%-30% [24][25] - The company anticipates adjusted EBITDA of $12 million to $14 million for 2026, indicating expected growth of 86%-100% over 2025 [25] Other Important Information - The FDA granted label expansion for the Deep TMS system to treat adolescents aged 15 to 21 suffering from major depressive disorder, expanding the addressable patient population [9] - The company received a $2.5 million NIH grant for a study on Deep TMS for alcohol use disorder, highlighting ongoing clinical research efforts [12][13] Q&A Session Summary Question: Can you give us a better sense of the Q4 placements as far as units sold, units leased, and also any color regarding OCD placements? - Management reported that 95 systems were shipped during Q4, with more than 50% including H7 coils [26] Question: Can you talk about the Deep TMS 360 trial? - The trial is designed for addiction and neurology markets, with 10 centers actively recruiting patients for alcohol use disorder and three centers for Alzheimer's disease [28][29] Question: Was there any pricing change in 2025 or anticipated for 2026? - Management does not anticipate a decrease in average selling price and aims to optimize pricing based on the value provided [31]

Financial Data and Key Metrics Changes - Company reported a 27% increase in revenue to $14.5 million for Q4 2025, with full-year revenue also growing 27% to $52.2 million compared to 2024 [4][17] - Gross profit for Q4 was $11.1 million, up from $8.5 million in the prior year, with gross margin increasing to 76% [18] - Operating income for Q4 was approximately $1.9 million, a significant increase from $0.4 million in the same period last year [21] - Net income for Q4 was $2.9 million, compared to $1.5 million in Q4 2024, with full-year net income of approximately $7.6 million compared to $2.9 million in 2024 [22] Business Line Data and Key Metrics Changes - 95 Deep TMS systems were shipped in Q4, bringing the total installed base to approximately 1,700 systems, a 26% increase year-over-year [4][17] - The book-to-bill ratio improved to 1.4x from 1.2x in the previous quarter, indicating strong demand [5] - Remaining performance obligation reached $70 million, representing a 43% growth from $49 million a year ago [5][22] Market Data and Key Metrics Changes - Company estimates it has penetrated less than 10% of the market for Deep TMS, indicating significant growth potential [6] - The FDA granted label expansion for Deep TMS to treat adolescents aged 15 to 21 with major depressive disorder, expanding the addressable patient population [8] Company Strategy and Development Direction - Company is focusing on expanding reimbursement coverage with payers across the U.S. to increase market share [7] - A strategic initiative is in place to secure minority equity investments in high-performing mental health providers, which is expected to facilitate growth and access to interventional psychiatry [13][14] - Long-term vision includes developing a portfolio of data-driven technology-enabled neuromodulation solutions to serve more patients [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the momentum in the business and expects revenue for 2026 to be in the range of $66 million to $68 million, representing a year-over-year growth rate of 27%-30% [23] - The company anticipates adjusted EBITDA of $12 million to $14 million for 2026, indicating expected growth of 86%-100% over 2025 [24] Other Important Information - Company maintained a strong cash position with $68 million in cash and cash equivalents as of December 31, 2025, supporting growth initiatives [22] - The SWIFT Deep TMS protocol is expected to significantly improve patient access and treatment efficiency, reducing the number of required office visits by 70% [10][11] Q&A Session Summary Question: Can you give us a little better sense of the fourth quarter placements as far as units sold, units leased, and also any color regarding OCD placements? - Company shipped 95 systems during Q4, with more than 50% including the H7 coils [25] Question: Can you talk about the Deep TMS 360 trial that's going on? - The TMS 360 is designed for addiction and neurology markets, with active recruitment for the alcohol use disorder trial in 10 centers across the U.S. [26][27] Question: As far as pricing, was there any pricing that you took in 2025 or would you anticipate any pricing for 2026? - Company does not anticipate any decrease in average selling price and aims to optimize pricing based on value provided [29] Question: What percentage of the $70 million obligations relates to commitments from existing strategic partners? - Each minority investment center is expected to deliver new backlog or booking of between $3-$5 million on a yearly basis [34] Question: Do you anticipate significant utilization of the SWIFT protocol for Deep TMS in conjunction with other therapies? - There is strong demand for TMS, and the SWIFT protocol is expected to be used in conjunction with other modalities, including psychedelics and medication management [39]

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]