Company: HROW
Filing Date: 2025-11-10
Form Type: 10-Q
Source: 0001493152-25-021562
Chunk: 126

Company: HARROW, INC.
Filing Date: 2025-11-10
Form: 10-Q
Item: Item 4
Chunk 126
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 directives—could cause additional delays or disruptions. If the FDA, CMS, or other agencies are unable to maintain adequate
staffing or operational continuity, it could result in increased regulatory uncertainty, slower review and approval timelines, or reimbursement
decisions that negatively affect utilization of our products by healthcare providers.

In
addition, continued or future government shutdowns or funding freezes could negatively affect broader economic conditions, including
volatility in the capital markets and reduced liquidity, which could make it more difficult for us to access capital or maintain adequate
financing for our operations. If these disruptions persist or worsen, our business, financial condition, results of operations, and ability
to execute our strategic plans could be materially and adversely affected.

We
sell our proprietary formulations primarily through pharmaceutical compounding facilities we own, and our results of operations may be
negatively impacted if such facilities do not comply with regulatory requirements or lose their licenses.

40

We
currently have two Imprimis compounding facilities in New Jersey. We have developed “ImprimisRx” as a uniform brand for
our compounding pharmaceutical business. As we have in the past purchased and operated certain pharmaceutical compounding businesses
and pharmacies and subsequently divested or sold those associated assets, we may pursue similar strategies in the future. Those
things considered, we may experience difficulties implementing and/or executing on our compounding pharmacy strategy, including
difficulties that arise as a result of our lack of experience, and we may be unsuccessful and our plans may change materially. For
instance:

●we
                                            have experienced delays and increased costs in relation to expansion efforts;

●we
                                            may not be able to satisfy applicable federal licensing, state board of pharmacy licensing
                                            and other requirements for any of our pharmacy businesses in a timely manner or at all;

●changes
                                            to federal and state pharmacy regulations may restrict compounding operations or make them
                                            more costly;

●we
                                            may be unable to achieve or maintain a sufficient physician and patient customer base to
                                            sustain our pharmacy operations;

●market
                                            acceptance of compounding pharmacies generally may be curtailed or delayed; and 

●We
                                            may not be able to enter into licensing or other arrangements with third-party pharmacies
                                            or outsourcing facilities when desired, on acceptable terms, or at all.

Our
ImprimisRx subsidiary completed an in-person meeting with the FDA in October 2025 regarding its efforts to remediate certain deficiencies
at its New Jersey site. At the FDA meeting, Im