Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 235

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 235
---
 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 we
interact with these entities.

 33 

Guidelines and recommendations
published by various organizations can reduce the use of our branded products.

Government agencies promulgate
regulations and guidelines directly applicable to us and to our products. Professional societies, practice management groups, insurance
carriers, physicians’ groups, private health and science foundations and organizations involved in various diseases also publish
guidelines and recommendations to healthcare providers, administrators and payors, as well as patient communities. Recommendations by
government agencies or other groups and organizations may relate to such matters as usage, dosage, route of administration and use of
related therapies. In addition, a growing number