Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 252

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 252
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 average sales prices for drugs. In addition,
this legislation authorized Medicare Part D prescription drug plans to use formularies where they can limit the number of drugs that
will be covered in any therapeutic class. As a result of this legislation and the expansion of federal coverage of drug products, we
expect that there will be additional pressure to contain and reduce costs. These cost reduction initiatives and other provisions of this
legislation could decrease the coverage and price that we receive for our drug candidates and could seriously harm our business. While
the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations
in setting their own reimbursement rates, and any reduction in reimbursement that results from the MMA may result in a similar reduction
in payments from private payors.

The Health Care Reform Law is
a sweeping law intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies
against fraud and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees
on the health industry and impose additional health policy reforms. The Health Care Reform Law revised the definition of “average
manufacturer price” for reporting purposes, which could increase the amount of Medicaid drug rebates to states. Further, the law
imposed a significant annual fee on companies that manufacture or import branded prescription drug products.

The Health Care Reform Law remains
subject to legislative efforts to repeal, modify or delay the implementation of the law. Efforts to date have generally been unsuccessful.
If the Health Care Reform Law is repealed or modified, or if implementation of certain aspects of the Health Care Reform Law are delayed,
such repeal, modification or delay may materially adversely impact our business, strategies, prospects, operating results or financial
condition. We are unable to predict the full impact of any repeal or modification in the implementation of the Health Care Reform Law
on us at this time.

In addition, other legislative
changes have been proposed and adopted in the U.S. since the Health Care Reform Law was enacted. We expect that additional federal healthcare
reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare
products and services, and in turn could significantly reduce the projected value of certain development projects and reduce or eliminate
our profitability.

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Our drug candidates may face competition sooner
than expected. 

Our success will depend in part
on our ability to obtain and maintain patent protection for certain of our drug candidates and