Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 236

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 236
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 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 significantly smaller than some of our competitors. Currently we lack some of the financial and other
resources needed to develop, produce, distribute and market our proprietary formulations at a level to capture a significant market share
in these sectors. The drug products available through branded and generic drug companies with which our formulations compete have been
approved for marketing and sale by the FDA and are required to be manufactured in facilities compliant with cGMP standards. Although
we prepare our compounded formulations in accordance with the standards provided by USP <795> and USP <797> and applicable
state and federal law, our proprietary compounded formulations are not required to be, and have not been,