Core Insights - BrainsWay has made a strategic investment of $5 million in Neurolief, which is developing the Proliv™Rx device pending FDA approval for treating Major Depressive Disorder (MDD) outside of clinical settings [1][2][4] - Neurolief's technology aims to address the significant gap in accessible therapies for treatment-resistant MDD patients, who often face prolonged suffering and higher healthcare costs [3][4] - The partnership is expected to enhance both companies' market presence and expand access to innovative mental health treatments [2][4] Company Overview - BrainsWay is a leader in non-invasive neurostimulation treatments for mental health disorders, with its Deep TMS™ platform technology having three FDA-cleared indications [6][7] - Neurolief is a pioneering company focused on developing wearable, non-invasive neuromodulation systems for mental health and neurological disorders, with its Relivion®MG therapy already approved for migraine treatment [8] Financial Aspects - The investment agreement includes potential milestone-based funding, with a second tranche of up to $6 million contingent on FDA approval of Neurolief's Proliv™Rx system, and a third tranche of up to $5 million based on revenue milestones [4] - The strategic investment is seen as a validation of Neurolief's technology and vision, aiming to reshape the treatment landscape for depression [4]

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]

Core Insights - BrainsWay Ltd. achieved record quarterly sales of $11.4 million in Q4 2024, marking a 27% increase compared to Q4 2023 [1][4] - The full year 2024 revenue rose nearly 30% year-over-year to $41 million [1][4] - The company exceeded its full year 2024 operating income and Adjusted EBITDA margin guidance [1] - For 2025, BrainsWay expects continued strong growth, projecting revenue between $49 million and $51 million, indicating a growth of 20% to 24% over 2024 [1][10] Q4 2024 Financial Highlights - Q4 2024 revenue was $11.4 million, a 27% increase from Q4 2023 [4] - A total of 75 Deep TMS™ systems were shipped, a 25% increase from the previous year [4] - Gross margin for Q4 2024 remained at 75%, consistent with the prior year [4] - Operating income for Q4 2024 was $0.4 million, up from $0.2 million in Q4 2023 [4] - Adjusted EBITDA for Q4 2024 was approximately $1.4 million, compared to $0.8 million in Q4 2023 [4] - Net income for Q4 2024 was $1.5 million, significantly higher than $0.1 million in Q4 2023 [4] Full Year 2024 Financial Highlights - Full year 2024 revenue reached $41 million, a 29% increase from 2023 [4] - Gross margin for the full year was 75%, slightly up from 74% in the previous year [4] - Operating income for the full year was $1.4 million, a turnaround from a loss of $5 million in 2023 [4] - Net income for the full year was $2.9 million, compared to a net loss of $4.2 million in 2023 [4] - Adjusted EBITDA for the full year was approximately $4.5 million, compared to an adjusted EBITDA loss of $2.4 million in the prior year [4] Strategic Developments - The company completed a $20 million strategic equity financing transaction with Valor Equity Partners [4] - As of December 31, 2024, cash and cash equivalents totaled $69.4 million, a significant increase from $10.5 million in 2023 [4][19] - BrainsWay received expanded FDA labeling for Deep TMS to treat late-life depression, broadening the age range for treatment [4] - The company reported a significant increase in Deep TMS treatments for anxious depression in the second half of 2024, addressing a large medical condition affecting millions in the U.S. [4] 2025 Financial Guidance - BrainsWay anticipates revenue for 2025 to be between $49 million and $51 million, representing a growth of 20% to 24% over 2024 [10] - The company targets an operating income of 3% to 4% and an Adjusted EBITDA of 11% to 12% for the full year 2025 [10]