Brainsway (NASDAQ:BWAY) reported fourth-quarter and full-year 2025 results that management said closed the year with “strong momentum,” driven by continued growth in its Deep TMS business and a shift toward recurring revenue through long-term leasing agreements. On the company’s earnings call, executives also highlighted recent FDA and payer-related developments, progress in clinical research, and an expanding backlog that they believe provides increased visibility into future revenue.
Financial performance and profitability
Chief Executive Officer Hadar Levy said fourth-quarter revenue increased 27% year over year to $14.5 million, while full-year revenue rose 27% to $52.2 million compared to 2024. Levy said the full-year result came in “slightly above the high end” of the company’s 2025 guidance.
BrainsWay posted fourth-quarter operating income of approximately $1.9 million, up from $0.4 million in the prior-year period. Full-year operating income was approximately $4.3 million compared with $1.4 million in 2024. Adjusted EBITDA increased to $2.3 million for the quarter, and the company reported full-year adjusted EBITDA of $7.0 million, or 13% of revenue, which Marom said was at the top end of guidance.
Net income was $2.9 million for the quarter, up from $1.5 million in Q4 2024. For the full year, net income was approximately $7.6 million compared with $2.9 million in 2024. Levy said the company has now delivered 10 consecutive quarters of profitability, which he attributed to expanding margins and implementation of its recurring model.
System placements, installed base, and backlog visibility
Management said BrainsWay shipped 95 Deep TMS systems during the fourth quarter, bringing the installed base to approximately 1,700 systems worldwide as of December 31, 2025, a 26% increase from the prior year. Levy noted the company exited the quarter with a book-to-bill ratio of 1.4x, up from 1.2x in the prior quarter.
BrainsWay’s remaining performance obligation (RPO) grew to $70 million, representing 43% growth from $49 million a year earlier. Levy said the expanding backlog reflects both demand and the company’s ability to monetize long-term commitments through recurring leasing contracts, which he said most enterprise customers now adopt with “a high rate of customer renewals.”
During the Q&A, management added that more than 50% of the 95 systems shipped in Q4 included the H7 coils.
Commercial strategy and pricing commentary
Levy said a key driver of recent results has been a strategic focus over the past two-plus years on large enterprise customers and a higher level of service to support those accounts. He said these customers have increasingly preferred the company’s leasing program, which management believes supports expansion and ongoing maintenance needs while creating a “highly attractive” recurring revenue model.
On pricing, Levy told analysts he does not anticipate a decrease in average selling price (ASP), adding that customers are willing to pay a premium for the company’s product and support. He also said the company aims to “optimize the pricing of our value,” rather than reduce prices.
Regulatory, reimbursement, and clinical updates
BrainsWay highlighted several developments intended to expand the addressable market and reduce access barriers:
- FDA label expansion in Q4: The FDA granted a label expansion for Deep TMS as an adjunct therapy for adolescents aged 15 to 21 with major depressive disorder (MDD). Levy said the clearance positions Deep TMS with the “broadest age range” for depression treatment, spanning patients 15 to 86 years old.
- Accelerated protocol clearance and coverage: The company said it received market clearance for an accelerated Deep TMS protocol for MDD and noted that several payers have begun covering the protocol. Management specifically cited Premera Blue Cross as the first to issue coverage for accelerated Deep TMS for adolescents and adult MDD patients, and said Highmark Blue Cross Blue Shield released a draft coverage policy for accelerated Deep TMS.
- SWIFT protocol data: Levy said the company recently announced data in two peer-reviewed manuscripts published in Brain Stimulation supporting its SWIFT Deep TMS protocol for MDD. He said the SWIFT approach reduces the number of clinic visits in the acute phase by 70% while maintaining efficacy.
- Administrative access changes: Management pointed to Evernorth Behavioral Health’s decision to eliminate prior authorization requirements for TMS for contracted providers treating patients under Evernorth and Cigna Healthcare plans, calling it a meaningful step toward expanding access.
In clinical development, the company said an NIH grant of $2.5 million was awarded for a Stanford study evaluating Deep TMS for alcohol use disorder (AUD). Levy said the study will use BrainsWay’s Deep TMS 360 system. In Q&A, he said the AUD trial is recruiting across 10 U.S. centers with a goal of enrolling “a little bit more than 200 patients overall,” and he hopes to recruit at least 50% of patients before year-end.
Levy also said the company is working with three neurology centers to launch a small feasibility study in Alzheimer’s disease to evaluate whether the 360 system’s rotational field could slow the disease. Separately, he said BrainsWay is preparing a submission to the FDA based on data from U.S. depression patients with comorbid PTSD symptoms, primarily treated within the VA system.
Levy noted that, in Israel, the Ministry of Defense Rehabilitation Department has approved reimbursement for Deep TMS therapy for qualifying PTSD patients treated in Israeli public hospitals, describing it as an important step in expanding access.
Strategic investments and 2026 outlook
BrainsWay also discussed a strategic initiative to secure minority equity investments in high-performing mental health providers with 5–50 centralized sites, which management said can help providers expand and open new locations. Levy said the company has announced minority investments in five mental health networks, including Brainstem Health, completed last month, and said invested providers are showing growth in demand for interventional psychiatry therapies in “2–3 quarters.” He added the company has identified more than 200 additional qualified clinics as potential candidates.
Levy further described a broader vision to build a portfolio of neuromodulation solutions. He highlighted BrainsWay’s investment in Neurolief, developer of Proliv Rx, a wearable at-home neuromodulation platform. Levy said the FDA granted Class III PMA labeling in January for Proliv Rx as an adjunct treatment for adult MDD patients, and said the agreement includes milestone-based funding of up to an additional $11 million of convertible loans over two tranches, along with an option to acquire the company.
For 2026, Marom guided for revenue of $66 million to $68 million, representing year-over-year growth of 27% to 30%. The company expects operating income of 13% to 14% of revenue and adjusted EBITDA of $12 million to $14 million, implying growth of 86% to 100% versus 2025.
On the balance sheet, Marom reported $68 million in cash and cash equivalents at year-end 2025 and said the company remains debt-free, with positive cash flow from operations in 2025.
About Brainsway (NASDAQ:BWAY)
Brainsway Ltd is a medical device company specializing in non-invasive neuromodulation therapies. Publicly traded on the NASDAQ under the symbol BWAY, the company develops and commercializes deep transcranial magnetic stimulation (Deep TMS) systems designed to treat a range of neuropsychiatric and neurological disorders. Brainsway’s technology aims to offer an alternative or complement to traditional pharmacological therapies by targeting precise brain regions with its patented coil designs.
The company’s flagship Deep TMS platform utilizes proprietary H-coil arrays engineered to reach deeper cortical structures than conventional TMS devices.
