Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 604

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 604
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 expansion of our operations, which may result in weaknesses in our infrastructure,
operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees. Our expected
growth could require significant capital expenditures and may divert financial resources from other projects, such as the development
of additional product candidates. If our management is unable to effectively manage our growth, our expenses may increase more than expected,
our ability to generate and/or grow revenue could be reduced and we may not be able to implement our business strategy. Our future financial
performance and our ability to commercialize our approved product and compete effectively will depend, in part, on our ability to effectively
manage any future growth.

Our international operations and plans to expand
such operations present challenges and risks related to doing business internationally.

International expansion of our
business further exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business
outside of the U.S., the EEA or Israel.

Other than our operations that
are located in the EEA and Israel (as further described below), we currently have limited international operations, but our business strategy
incorporates potentially significant international expansion, particularly in anticipation of certification or regulatory approval of
our product candidates. We plan to maintain non-commercial infrastructure and conduct physician and patient association outreach activities,
as well as clinical trials, outside of the U.S., the EEA and Israel. Doing business internationally involves a number of risks, including
but not limited to:

    ●
    multiple, conflicting and changing laws and regulations such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental certification, approvals, permits and licenses;

    ●
    failure by us to obtain certification or regulatory approvals for the use of our products in various countries;

    ●
    additional potentially relevant third-party patent rights;

    ●
    complexities and difficulties in obtaining protection and enforcing our intellectual property;

    ●
    difficulties in staffing and managing foreign operations;

    ●
    complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems;

    ●
    limits on our ability to penetrate international markets;

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    ●
    financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products and exposure to foreign currency exchange rate fluctuations;

    ●
    natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts,