Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 55

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 55
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 or those they manage, and to
also impose restrictions on access to or usage of our branded products (such as step therapy), require that patients receive the payor’s
prior authorization before covering the product, and/or chosen to exclude certain indications for which our products are approved. In
an effort to reduce barriers to access, we may reduce the net price of some of our branded products by providing greater discounts and
rebates to payors (including PBMs that administer Medicare Part D prescription drug plans), and we may introduce a set of new National
Drug Codes to make our branded products available at a lower list price. However, affordability of patient out-of-pocket co-pay cost
has limited and may continue to limit patient use. Further, despite these net and list price reductions, some payors may restrict, patient
access and may seek further discounts or rebates or take other actions, such as changing formulary coverage for some or all of our branded
products. These factors have limited, and may continue to limit, patient affordability and use, negatively affecting sales of our branded
products.

Further, significant
consolidation in the health insurance industry has resulted in a few large insurers and PBMs, which places greater pressure on
pricing and usage negotiations with biopharmaceutical manufacturers, significantly increasing discount and rebate requirements and
limiting patient access and usage. For example, in the U.S., as of the beginning of 2024, we believe the top five integrated health
plans and PBMs controlled approximately 92% of all pharmacy prescriptions. This high degree of consolidation among insurers and PBMs
and other payors, including through integrated healthcare delivery systems and/or with specialty or mail-order pharmacies and
pharmacy retailers, has increased the negotiating leverage such entities have over us and other biopharmaceutical manufacturers and
has resulted in greater price discounts, rebates and service fees realized by those payors from our business. CVS, Express Scripts
and United Health Group (among the top five integrated health plans and PBMs), each have Rebate Management Organizations that
further increase their leverage to negotiate deeper discounts. Ultimately, additional discounts, rebates, fees, coverage changes,
plan changes, restrictions or exclusions imposed by these commercial payors could have a material adverse effect on our product
sales, business and results of operations. Policy reforms advanced by Congress or the others in the federal administration that
refine the role of PBMs in the U.S. marketplace could have downstream implications or consequences for our business and how