Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 16

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 16
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) in these disorders that complicate treatment methods. Diagnosis for psychiatric disorders, such as MDD and OCD,
is based on an individual’s reported experiences and mental status examination, and accordingly is subject to significant error.
For example, it is estimated that about half of the individuals in the United States who experience a major depressive episode annually
are not diagnosed correctly. In addition, there is a rising trend in which primary care providers, rather than mental health professionals,
prescribe anti-depressant medications. While we view this as an overall positive development for the industry, any errors in diagnosing
the underlying condition can impact the appropriateness - and thus efficacy - of any treatments administered, including Deep
TMS. In addition, the H-Coils for our Deep TMS systems may prove to be interchangeable in some respects, and clinicians may be able to
treat patients with multiple disorders in the same procedure. With respect to comorbidities, there is a high rate of tobacco use amongst
patients suffering from mental health conditions such as depression and anxiety. Approximately 3 of every 10 cigarettes smoked by adults
in the United States are smoked by persons with mental health conditions. As a result of the foregoing factors, the addressable market
for Deep TMS for MDD (including reduction of comorbid anxiety symptoms, commonly referred to as anxious depression), OCD, and smoking
addiction, may be smaller than we currently anticipate, and predictions for our future growth may prove to be inaccurate. This may have
a materially adverse effect on our future results of operations.

If our sales and customer support teams or
independent third-party distributors and agents are not sufficiently skilled or fail to reach additional markets and adequately promote,
market and sell or lease our Deep TMS systems, our revenues could significantly decrease and we may not generate sufficient revenues to
sustain profitability.

As of December 31, 2024, we had 120 employees, including
53 employees in sales and marketing. Our operating results are directly dependent upon the sales and marketing efforts of our sales and
customer support team and on our independent third-party distributors and agents outside of the United States. If our employees or our
independent distributors and agents fail to adequately promote, market and sell or lease our Deep TMS systems, our revenues could significantly
decrease and/or fail to meet our targets.

In addition, our future revenues will largely depend
on our ability to successfully execute our marketing efforts and adequately address our customers’ needs. In certain territories,
it