Company: HROW
Filing Date: 2025-08-11
Form Type: 10-Q
Source: 0001641172-25-022980
Chunk: 106

Company: HARROW, INC.
Filing Date: 2025-08-11
Form: 10-Q
Item: Item 4
Chunk 106
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. As part of our commitment to actively
work with regulators, at times, we have become aware of concerns related to certain formulations, and as a result, discontinued compounding
certain drug formulations in an attempt to help mitigate potential regulatory risk. For other reasons, including, but not limited to,
the following, physicians may be unwilling to prescribe or patients may be unwilling to use our compounded formulations: legal prohibitions
on our ability to discuss the efficacy or safety of our formulations with potential users to the extent applicable data is available;
our pharmacy operations are primarily operating on a cash-pay basis and reimbursement may or may not be available from third-party payors,
including the government Medicare and Medicaid programs; and certain formulations are not required to be prepared and are not presently
being prepared in a manufacturing facility governed by cGMP requirements. These factors and any future regulatory action could continue
to limit our production, and our ability to dispense and distribute our compounded products, which would negatively affect sales of our
compounded products.

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

Sales
of our products depend on the availability and extent of coverage and reimbursement from third-party payers, including government healthcare
programs and private insurance plans. Governments and private payers continue to pursue initiatives to manage drug utilization and contain
costs. Further, pressures on healthcare budgets from the economic downturn and inflation continue and are likely to increase, across
the markets we serve. Payers are increasingly focused on costs, which has resulted, and is expected to continue to result, in lower reimbursement
rates for our products and/or narrower patient populations for which payers will reimburse. Continued intense public scrutiny of the
price of drugs and other healthcare costs, together with payer dynamics, have limited, and are likely to continue to limit, our ability
to set or adjust the price of our products based on their value, which can have a material adverse effect on our business. In the United
States, particularly over the past few years, a number of legislative and regulatory proposals have been introduced and/or signed into
law to lower drug prices. These include provisions in the Inflation Reduction Act that enable the U.S. government to set prices for certain
drugs in Medicare, redesign Medicare Part D benefits to shift a greater proportion of the costs to manufacturers and health plans and
enable the U.S. government to impose penalties if drug prices