Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 15

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 15
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 patient candidates
for Deep TMS treatment and/or utilize unprescribed protocols it could result in variability of the treatment efficacy and results for
the patient. Our ability to generate significant revenues from Deep TMS relies on physicians’ and patients’ satisfaction with
the effectiveness of Deep TMS and if physicians or patients are not satisfied with the results of Deep TMS, our reputation, and future
results of operations may be adversely affected.

We may be
unable to predict and/or manage our anticipated growth effectively, which could make it difficult to execute our business strategy and
we may even be unable to forecast our future growth accurately.

We intend to continue to grow our business operations
and may experience periods of rapid growth and expansion. This anticipated growth could create a strain on our organizational, administrative
and operational infrastructure, including our supply chain operations, quality control, technical support and customer service, sales
force management and general and financial administration. These risks increase as we expand into new countries, each entailing varied
and often time-consuming regulatory challenges and requirements. We may be unable to maintain the quality, regulatory infrastructure,
or delivery timelines of our products or customer service, or satisfy customer demand if our business grows too rapidly. Our ability to
manage our growth properly will require us to continue to improve our operational, financial and management controls, and our reporting
systems and procedures. We may implement new enterprise software systems in a number of areas affecting a broad range of business processes
and functional areas. The time and resources required to implement these new systems is uncertain and failure to complete this in a timely
and efficient manner could harm our business.

As our commercial operations and sales volume grow,
we will need to continue to increase our workflow capacity for our supply chain, regulatory expansion, customer service, training and
education personnel, billing, accounting reporting and general process improvements and expand our internal quality assurance program,
among other things. Our current workforce may not be sufficient to handle our expanding growth and we will be required to expand and train
additional personnel as we increase our sales efforts. We may not successfully implement these increases in scale or the expansion of
our personnel, which could harm our business.

  10  

Moreover, we may be unable to predict future growth
related to Deep TMS for MDD (including reduction of comorbid anxiety symptoms, commonly referred to as anxious depression), OCD, smoking
addiction, and other psychiatric indications because some of these disorders are inherently difficult to diagnose and there are frequent
co-morbidities (overlap