Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 237

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 237
---
 approved for marketing and
sale by the FDA. As a result, some physicians may be unwilling to prescribe, and some patients may be unwilling to use, our formulations.
Additionally, under federal and state laws applicable to our current compounding pharmacy operations, we are not permitted to prepare
significant amounts of a specific formulation in advance of a prescription, compound quantities for office use or utilize a wholesaler
for distribution of our formulations; instead, our compounded formulations must be prepared and dispensed in connection with a physician
prescription for an individually identified patient. Pharmaceutical companies, on the other hand, are able to sell their FDA-approved
products to large pharmaceutical wholesalers, which can in turn sell to and supply hospitals and retail pharmacies. Even if we are successful
in registering certain of our facilities as outsourcing facilities, our business may not be scalable on the scope available to our competitors
that produce FDA-approved drugs, which may limit our potential for profitable operations. These facets of our operations may subject
our business to limitations our competitors with FDA-approved drugs may not face.

 34 

Our future success depends in large part on
our ability to maintain a competitive position with respect to biotechnology and related pharmaceutical technologies.

Biotechnology and related pharmaceutical
technologies have undergone and continue to be subject to rapid and significant change. Our future success will depend in large part
on our ability to maintain a competitive position with respect to these technologies. Products developed by our competitors, including
FDA-approved drugs and compounded formulations created by other pharmacies, could render our products and technologies obsolete or unable
to compete. Any products that we develop may become obsolete before we recover expenses incurred in their development, which may require
us to raise additional funds that may or may not be available. The competitive environment requires an ongoing, extensive search for
medical and technological innovations and the ability to develop and market these innovations effectively, and we may not be competitive
with respect to these factors. Other competitive factors include the safety and efficacy of a product, the size of the market for a product,
the timing of market entry relative to competitive products, the availability of alternative compounded formulations or approved drugs,
the price of a product relative to alternative products, the availability 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