Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 546

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 546
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If the market opportunities for our approved
product or product candidates are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer.

Our projections of both the number
of people who have our target diseases, as well as the subset of people with these diseases who have the potential to benefit from treatment
with LungFit® PH and our product candidates, are based on our beliefs and estimates. These estimates have been derived
from a variety of sources, including scientific literature, surveys of clinics, patient foundations or market research and may prove to
be incorrect. Further, new studies may change the estimated incidence or prevalence of these diseases. The number of patients may turn
out to be lower than expected. The effort to identify patients with diseases we seek to treat is in early stages, and we cannot accurately
predict the number of patients for whom treatment might be possible. Additionally, the potentially addressable patient population for
LungFit® PH and each of our product candidates may be limited or may not be amenable to treatment with LungFit®
PH or our product candidates, and new patients may become increasingly difficult to identify or gain access to, which would adversely
affect our results of operations and our business.

The insurance coverage and reimbursement status
of newly-approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new or current products
could limit our ability to market those products and decrease our ability to generate revenue.

The pricing, coverage and reimbursement
of our approved product and product candidates, if approved, must be adequate to support our commercial infrastructure. Our per-patient
prices must be sufficient to recover our development and manufacturing costs and potentially achieve profitability. Accordingly, the availability
and adequacy of coverage and reimbursement by governmental and private payors are essential for most patients to be able to afford expensive
treatments such as ours, assuming certification or approval. Sales of our approved product and product candidates will depend substantially,
both domestically and abroad, on the extent to which the costs of our approved product and product candidates will be paid for by health
maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government authorities,
private health insurers and other third-party payors. If coverage and reimbursement are not available, or are available only to limited
levels, we may not be able to successfully commercialize our approved product and product candidates. Even if coverage is provided, the
approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient