Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 74

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 74
---
, market acceptance and commercial success would be reduced.

Coverage and reimbursement may be limited or unavailable for
our product candidates, if approved, which could make it difficult for us to sell any product candidates profitably.

Significant uncertainty exists as to the insurance coverage and reimbursement
status of any products for which we may obtain regulatory approval. In the United States, sales of any products for which we may
receive regulatory approval will depend, in part, on the availability of coverage and reimbursement from third-party payors. Third-party payors
include government authorities such as Medicare, Medicaid, TRICARE, and the Veterans Administration, managed care providers, private health
insurers, and other organizations. Patients who are provided medical treatment for their conditions generally rely on third-party payors
to reimburse all or part of the costs associated with their treatment. Coverage and adequate reimbursement from governmental healthcare
programs, such as Medicare and Medicaid, and commercial payors are critical to new product acceptance. Patients are unlikely to use our
product candidates unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost. We cannot be
sure that coverage and reimbursement will be available for, or accurately estimate the potential revenue from, our product candidates
or assure that coverage and reimbursement will be available for any product that we may develop.

39

Government authorities and other third-party payors decide which
drugs and treatments they will cover and the amount of reimbursement. Coverage and reimbursement by a third-party payor may depend
upon a number of factors, including the third-party payor’s determination that use of a product is:

●a covered benefit under its health plan;

●safe, effective and medically necessary;

●appropriate for the specific patient;

●cost-effective; and

●neither experimental nor investigational.

In the United States, no uniform policy of coverage and reimbursement
for products exists among third-party payors. As a result, obtaining coverage and reimbursement approval of a product from a government
or other third-party payor is a time-consuming and costly process that could require us to provide to each payor supporting
scientific, clinical and cost-effectiveness data for the use of our products, with no assurance that coverage and adequate reimbursement
will be obtained. Even if we obtain coverage for a given product, the resulting reimbursement payment rates might not be adequate for
us to achieve or sustain profitability or may require co-payments that patients find unacceptably high. Additionally, third-party