Company: HROW
Filing Date: 2025-08-11
Form Type: 10-Q
Source: 0001641172-25-022980
Chunk: 114

Company: HARROW, INC.
Filing Date: 2025-08-11
Form: 10-Q
Item: Item 1A
Chunk 114
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 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 are increased at a rate faster than inflation. Additional proposals focused
on drug pricing continue to be debated, and additional executive orders or regulatory initiatives focused on drug pricing and competition
are likely to be adopted and implemented in some form. It is unclear what policies will advance with respect to other drug pricing proposals,
including international reference pricing or changes to healthcare regulations affecting pharmaceuticals. Further, state government activity
has been dynamic, including certain states enacting new laws limiting drug reimbursement under state run Medicaid programs and prohibiting
restrictions on 340B Program use. Such state laws could 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 payer 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 and results of operations.

37

Global
economic conditions may negatively affect us and may magnify certain risks that affect our business.

Our
operations and performance have been, and may continue to be, affected by global economic conditions. The economic downturn resulting
from the COVID-19 pandemic precipitated a global recession, which was followed by high rates of inflation and actions taken by financial
regulators to raise interest rates. Instability in the financial system, tighter lending standards and higher interest rates have added
stress that may create additional vulnerabilities in the global economy, the effects of which may be of an extended duration. Additionally,
with higher interest rates, deficits (including those associated with the pandemic), and other