Brainsway Ltd. Stock Price, News & Analysis

BrainsWay (NASDAQ & TASE: BWAY), a leader in noninvasive neurostimulation treatments for mental health disorders, has announced its plan to report second quarter 2024 financial results on August 6, 2024, before U.S. financial markets open. The company will host a conference call and webcast at 8:30 AM Eastern Time to discuss results and provide operational updates.

Investors can access the call via phone or webcast. The webcast will be available for replay for 30 days on BrainsWay's investor relations website. This announcement provides shareholders and analysts with a scheduled opportunity to review the company's financial performance and engage with management about recent developments and future prospects.

BrainsWay has announced an exclusive multi-year distribution agreement to market its Deep Transcranial Magnetic Stimulation (Deep TMS) system in Canada. The agreement involves a specialty distributor serving acute and non-acute healthcare sectors, and includes minimum quantity orders, starting with 11 systems in 2024. BrainsWay’s CEO, Hadar Levy, emphasized the significance of expanding into Canada to address the country's mental health crisis. The Deep TMS system, which uses a patented coil design to stimulate brain neural networks, is currently approved in Canada for treating major depressive disorder and obsessive-compulsive disorder.

BrainsWay has launched a new clinical trial to evaluate an accelerated treatment protocol for its Deep Transcranial Magnetic Stimulation (Deep TMS) system, targeting major depressive disorder (MDD). This multicenter, randomized, controlled trial will compare a novel accelerated protocol to the FDA-cleared standard-of-care protocol. Over 100 patients will participate, with one group receiving an acute treatment phase over several days and the other over several weeks. The trial aims to determine if the accelerated protocol is as effective as the traditional method. Recruitment is ongoing across multiple U.S. sites.

BrainsWay has announced that the FDA has expanded the indication for its Deep Transcranial Magnetic Stimulation system (Deep TMS™) to treat major depressive disorder (MDD) in patients aged 22 to 86, extending beyond the previous age limit of 68. This marks the company's 10th FDA clearance, making their Deep TMS the only TMS device approved for depression treatment in patients over 68. The expanded labeling is supported by clinical data showing significant response and remission rates in older patients. BrainsWay sees this as a promising business opportunity, given the rising life expectancy and the need for effective depression treatments in the elderly.

BrainsWay reported a 37% year-over-year revenue growth in Q1 2024, achieving positive net income for the second consecutive quarter. The company also recorded positive Adjusted EBITDA and cash flow from operations for the third consecutive quarter. Revenues reached $9.1 million, with a gross margin of 75%. Operating income was $0.1 million compared to a loss of $3.7 million in the same period last year. Net income was $0.1 million, an improvement from a net loss of $2.4 million in Q1 2023. The Company's cash, cash equivalents, and short-term deposits stood at $47.8 million as of March 31, 2024. BrainsWay shipped 57 Deep TMS™ systems in Q1 2024, bringing the total installed base to 1,158 systems. Collaboration with partner Katie’s Way Plus expanded, and the Company installed its 11th Deep TMS system in Israel. With strong Q1 results, BrainsWay reaffirmed its full-year 2024 revenue guidance of $37 million to $40 million, expecting continued growth and profitability throughout the year.