Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 11

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 11
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 of third-party reimbursement, the success of sales and marketing
efforts, brand recognition and the availability of scientific and technical information about a product. Although we believe we are positioned
to compete favorably with respect to many of these factors, if our proprietary formulations are unable to compete with the products of
our competitors, we may never gain a significant market share or achieve profitability.

Factors Affecting Our Performance

We believe
the primary factors affecting our performance are our ability to increase revenues of our ophthalmic products, grow and gain operating
efficiencies in our pharmacy operations, successfully adjust our operations to account for any future regulatory-related restrictions,
optimize pricing and obtain reimbursement options for our ophthalmic products, and continue to pursue development and commercialization
opportunities for certain of our ophthalmology and other assets that we have not yet made commercially available or have been recently
launched. We believe we have built a tangible and intangible infrastructure that will allow us to scale revenues efficiently in the near
and long-term. All of these activities will require increased costs and other resources, which we may not have or be able to obtain from
operations or other sources. See “Liquidity and Capital Resources” below.

Medicare, Medicaid and Other Reimbursement Options

Sales
in the U.S. of our marketed products are dependent, in large part, on the availability and extent of reimbursement from third-party payors,
including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and
government programs such as Medicare and Medicaid. See Item 1A. “Risk Factors” for risks related to reimbursement and government
programs.

We participate
in, and have certain price reporting obligations to, the Medicaid Drug Rebate program, state Medicaid supplemental rebate program(s),
and other governmental pricing programs. We also have obligations to report the average sales price for certain drugs to the Medicare
program. Under the Medicaid Drug Rebate program, we are required to pay a rebate to each state Medicaid program for our covered outpatient
drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds being
made available for our drugs under Medicaid and Part B of the Medicare program.

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Medicare
is a federal program that is administered by the federal government that covers individuals age 65 and over or that are disabled as well
as those with certain health conditions. Medicare Part B generally covers drugs that must be administered by physicians or other health