Company: HROW
Filing Date: 2025-11-10
Form Type: 10-Q
Source: 0001493152-25-021562
Chunk: 137

Company: HARROW, INC.
Filing Date: 2025-11-10
Form: 10-Q
Item: Item 1A
Chunk 137
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 out regulatory and policy functions. In March 2025, the Secretary of HHS announced a
departmental reorganization and reduction-in-force initiative that included workforce adjustments at the FDA and other HHS components.
Although the precise scope and timing of these changes remain uncertain, further reductions in agency staffing or funding could limit
the government’s ability to provide timely guidance, review regulatory submissions, or issue reimbursement decisions. Similarly,
proposed future budget constraints for HHS could affect CMS’s ability to update coverage and payment policies, which may influence
healthcare providers’ adoption of our products.

Significant
changes to the operations, priorities, or funding of these agencies—whether resulting from shutdowns, staffing reductions, or shifting
policy 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