20-F: BrainsWay 2025 Annual Report: Growth and Expansion

BrainsWay reports strong 2025 financial growth, achieving $52.2 million in revenue and $7.6 million in net income.

Summary

• Achieved total revenue of $52.2 million for the fiscal year ended December 31, 2025, a 27.3% increase from $41.0 million in 2024.
• Reported net income of $7.6 million for 2025, compared to $2.9 million in 2024.
• Expanded FDA clearances for MDD to include adolescent patients (ages 15-21) and an accelerated treatment protocol (SWIFT).
• Installed base reached 1,781 systems as of December 31, 2025, an increase of 428 systems during the year.
• Entered into strategic investments in several Management Service Organizations (MSOs) and a multi-phased investment in Neurolief.

Sentiment

Score: 8

Explanation: StockSavvy.ai views this as a strong performance, reflecting successful commercial execution and expanded clinical utility, though tempered by geopolitical risks and customer concentration.

Positives

• Revenue growth of 27.3% year-over-year.
• Achieved profitability with $7.6 million net income.
• Expanded FDA labeling for MDD to include adolescents and accelerated treatment protocols.
• Strong cash position with $67.9 million in cash, cash equivalents, and restricted cash.
• Successful expansion of the installed base to 1,781 systems.

Negatives

• Significant revenue concentration with a single large enterprise customer.
• Accumulated deficit remains at $90.8 million despite recent profitability.
• Increased operating expenses due to higher headcount and clinical trial investments.
• Exposure to geopolitical instability in Israel affecting operations and supply chain.

Risks

• Reliance on a single customer for a significant portion of revenue.
• Potential for future operating losses if commercialization efforts do not sustain growth.
• Geopolitical instability in Israel impacting manufacturing and R&D operations.
• Intellectual property litigation risks, including a recent claim from Magnus Medical Inc.
• Regulatory risks regarding compliance with FDA and foreign health authority requirements.
• Dependence on third-party suppliers for critical components.

Future Outlook

The company expects research, development, and clinical trial expenses to remain significant as it advances next-generation technology, including multichannel and rotational field TMS, and seeks FDA clearance for new indications such as fatigue in MS and various addictions.

Management Comments

• Management believes existing cash resources are sufficient to fund operating expenses and capital requirements in the foreseeable future.
• The company is focused on increasing global awareness and broad access to Deep TMS.

Industry Context

StockSavvy.ai notes that BrainsWay is navigating a competitive landscape in the neuromodulation sector, increasingly shifting toward accelerated treatment protocols and at-home therapy solutions, while managing significant geopolitical risks inherent to its Israel-based operations.

Comparison to Industry Standards

• BrainsWay is the only TMS company with FDA clearance for three separate mental health indications (MDD, OCD, smoking addiction).
• Competitors include Neuronetics, MagVenture, and Magnus Medical, with the latter recently receiving FDA clearance for its SAINT protocol.
• The company's shift toward accelerated protocols aligns with industry trends to reduce treatment burden.

Management Changes

Corporate Governance

Legal Proceedings

• Defending a lawsuit by a patient alleging hearing loss following clinical study participation.
• Addressing a claim by Magnus Medical Inc. regarding alleged IP infringement related to accelerated stimulation protocols.

Related Party Transactions

• Private placement of securities to Valor BrainsWay Holdings, LLC.
• Consulting agreement with Prof. Abraham Zangen.
• Sponsorship of an obesity study at Ben-Gurion University.

Stakeholder Impact

• Shareholders benefit from improved profitability and revenue growth.
• Patients gain access to new adolescent and accelerated treatment options.
• Customers face potential risks related to supply chain and enterprise account concentration.

Next Steps

• Continue clinical trials for next-generation multichannel and rotational field TMS devices.
• Pursue FDA clearance for new indications including fatigue in MS and substance addictions.
• Integrate cloud-based capabilities into the Deep TMS platform.

Key Dates

Recommendation

The company demonstrates strong revenue growth, achieved profitability, and a clear path for continued expansion through new FDA clearances and strategic investments, justifying a positive outlook despite geopolitical and concentration risks.

Keywords

Deep TMS, Neurostimulation, Mental Health, MDD, OCD, Neurolief, Medical Devices, BrainsWay