Company: HROW
Filing Date: 2025-08-11
Form Type: 10-Q
Source: 0001641172-25-022980
Chunk: 69

Company: HARROW, INC.
Filing Date: 2025-08-11
Form: 10-Q
Item: Item 1
Chunk 69
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 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 fiscal pressures, governments may be unable
to sustain their previously high levels of fiscal spending. As a result of global economic conditions, some third-party payers may delay
or be unable to satisfy their reimbursement obligations. Job losses or other economic hardships (including inflation) may also affect
patients’ ability to afford healthcare as a result of increased co-pay or deductible obligations, greater cost sensitivity to existing
co-pay or deductible obligations, lost healthcare insurance coverage or for other reasons. We believe such conditions could lead to reduced
demand for our products, which could have a material adverse effect on our product sales, business and results of operations. The cumulative
effects of inflationary pressures, an uncertain trade environment with escalating and rapidly-changing tariffs, and the effects from
the armed conflict in Ukraine (including the effects of the sanctions that were implemented in response to the conflict and the resulting