Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 209

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 209
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Risk Factors Summary

We are subject to a variety of
risks and uncertainties, including financial risks, operational risks, human capital risks, legal proceedings and regulatory risks and
certain general risks, that could have a material adverse effect on our business results of operations, financial condition and prospects.
Risks that we deem material are described below and include, but are not limited to, the following: 

Risks Related to Economic Conditions and Operations
of Our Business. 

    ●
    Our ability to achieve and maintain profitability for our business

    ●
    Our ability to successfully market, commercialize, and sell current,
    recently acquired and future products

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    ●
    Our current indebtedness and ability to access additional capital

    ●
    Our ability to attract customers and increase sales of current and
    future products

    ●
    Our ability to obtain marketing approval and ongoing expense associated
    with it for any of our drug candidates, including those for which we own royalty rights

    ●
    Our reliance on third parties for manufacturing certain components,
    FDA approved drugs and to conduct clinical trials

    ●
    Our exposure to liabilities and reputation harm if our products give
    rise to defects, recalls, patient injury or death

    ●
    Our information technology systems exposure to cyberattack or information
    security breach could significantly compromise the confidentiality, integrity and availability of our information technology systems

Risks Related to Government Regulations and Third-Party
Policies

    ●
    Our business may be affected by litigation,
government investigations and injunctive actions

    ●
    Governmental regulations, including, but not limited to, 503B bulks list and others, that could or currently do burden operations or narrow
the market for our products

    ●
    Our sales depend on coverage and reimbursement from government and
    commercial third-party payors, and pricing and reimbursement pressures have affected, and are likely to continue to affect, our profitability

    ●
    The adoption and interpretation of new tax legislation or exposure
    to additional tax liabilities could affect our profitability

Risks Related to Competition

    ●
    Securing and maintaining patent or other intellectual property protection
    for our products and related improvements

    ●
    Market acceptance of our drug products, drug candidates, compounded
    drugs and pharmacies

    ●
    Our ability to successfully research, develop and timely manufacture
    our current and future products and drug candidates

    ●