Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 232

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 232
---
 to continue
to affect, our profitability.

Sales of our branded products
depend on the availability and extent of coverage and reimbursement from third-party payors, including government healthcare programs
and private insurance plans. Governments and private payors continue to pursue initiatives to manage drug utilization and contain costs.
Further, pressures on healthcare budgets from the pandemic, the economic downturn and inflation continue and are likely to increase across
the markets we serve. Payors are increasingly focused on costs, which have resulted, and are expected to continue to result, in lower
reimbursement rates for our branded products or narrower populations for which payors will reimburse. Continued intense public scrutiny
of the price of drugs and other healthcare costs, together with payor 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 U.S., particularly over the past few years, a number of legislative and regulatory proposals have been introduced and/or signed into
law that attempt to lower drug prices. These include legislation promulgated by the IRA that enables the U.S. government to set prices
for certain drugs in Medicare, redesigns Medicare Part D benefits to shift a greater portion of the costs to manufacturers and enables
the U.S. government to impose penalties if drug prices are increased at a rate faster than inflation in addition to rebates imposed on
manufacturers associated with drug waste (which could potentially impact sales of TRIESENCE). Additional proposals focused on drug pricing
continue to be debated, and additional executive orders focused on drug pricing and competition are likely to be adopted and implemented
in some form. Government actions or ballot initiatives at the state level also represent a highly active area of policymaking and experimentation,
including pursuit of proposals that limit drug reimbursement under state run Medicaid programs based on reference prices or permitting
importation of drugs from Canada. Such state policies may also eventually be adopted at the federal level.

We are unable to predict which
or how many policy, regulatory, administrative or legislative changes may ultimately be, or effectively estimate the consequences to
our business if, enacted and implemented. However, to the extent that payor actions further decrease or modify the coverage or reimbursement
available for our products, require that we pay increased rebates or shift other costs to us, limit or affect our decisions regarding
the pricing of or otherwise reduce the use of our products, such actions could have a material adverse effect on our business