Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 311

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 311
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for commercial sale, will depend on a number of factors, including:

●the efficacy and potential advantages compared to alternative
treatments;

●the ability to offer our products, if approved, for sale at
competitive prices;

●the convenience and ease of administration compared to alternative
treatments;

●the willingness of the target patient population to try new
therapies and of physicians to prescribe these therapies;

●the price we pay or any of our future collaborators charge for
our products;

●the recommendations with respect to our product candidates in
guidelines published by various scientific organizations applicable to us and our product candidates;

●the strength of marketing and distribution support;

●the ability to obtain sufficient third-party coverage and
adequate reimbursement;

●the prevalence and severity of any side effects; and

●the size and effectiveness of our sales, marketing and distribution
support.

If government and other third-party payors do not provide coverage
and adequate reimbursement levels for any products we commercialize, 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