Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 73

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 73
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 product
candidates, our revenue will be dependent upon, in part and among other things, the size of the markets in the geographic areas for which
we gain regulatory approval, the number of competitors in such markets, the accepted price for product candidates and whether we own the
commercial rights for those territories. If the indication approved by regulatory authorities is narrower than expected, or the treatment
population is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of
our product candidates, even if approved (especially for products receiving orphan drug designations). We cannot assure you that we will
be profitable even if we successfully commercialize our product candidates.

Even if a product candidate we develop receives regulatory approval,
it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical
community necessary for commercial success.

Even if a product candidate we own or develop receives regulatory approval,
it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors, such as Medicare and Medicaid
programs and managed care organizations, and others in the medical community. In addition, the availability of coverage by third-party payors
may be affected by existing and future health care reform measures designed to reduce the cost of health care. If the product candidates
we develop do not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable.

The degree of market acceptance of any product candidate, if approved
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