Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 56

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 56
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 we
interact with these entities.

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Guidelines and recommendations
published by various organizations can reduce the use of our branded products.

Government agencies promulgate
regulations and guidelines directly applicable to us and to our products. Professional societies, practice management groups, insurance
carriers, physicians’ groups, private health and science foundations and organizations involved in various diseases also publish
guidelines and recommendations to healthcare providers, administrators and payors, as well as patient communities. Recommendations by
government agencies or other groups and organizations may relate to such matters as usage, dosage, route of administration and use of
related therapies. In addition, a growing number of organizations are providing assessments of the value and pricing of biopharmaceutical
products, and even organizations whose guidelines have historically been focused on clinical matters have begun to incorporate analyses
of the cost effectiveness of various treatments into their treatment guidelines and recommendations. Value assessments may come from
private organizations that publish their findings and offer recommendations relating to the products’ reimbursement by government
and private payors. Some companies and payors have announced pricing and payment decisions based in part on the assessments of private
organizations. In addition, government health technology assessment organizations in many countries make reimbursement recommendations
to payors in their jurisdictions based on the clinical effectiveness, cost-effectiveness and service effects of new, emerging and existing
medicines and treatments. Such health technology assessment organizations have recommended, and may in the future recommend, reimbursement
for certain of our products for a narrower indication than was approved by applicable regulatory agencies or may recommend against reimbursement
entirely. See the risk factor, 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. Such recommendations
or guidelines may affect our reputation, and any recommendations or guidelines that result in decreased use, dosage or reimbursement
of our products could have a material adverse effect on our product sales, business and results of operations. In addition, the perception
by the investment community or stockholders that such recommendations or guidelines will result in decreased use and dosage of our products
could adversely affect the market price of our common stock.

Risks Related to Competition

There are many competitive risks related to
marketing and selling our proprietary formulations and operating our compounding pharmacy business.

The pharmaceutical and pharmacy
industries are highly competitive. We compete against branded drug companies, generic drug companies, outsourcing facilities and other
compounding pharmacies. We are