Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 75

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 75
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payors
may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required following the use of product
candidates, once approved. It is difficult to predict what third-party payors will decide with respect to the coverage and reimbursement
for our product candidates, if approved.

Additionally, our ability to obtain and maintain coverage for our products
by certain government health care programs may depend on our participation in certain government pricing programs, such as the Medicaid
Drug Rebate Program and the 340B program. These programs often include complex reporting and payment obligations, which are subject to
frequent change. If we fail to provide timely and accurate information under these programs or comply with any rebate or discount pricing
requirements, we may have reimbursement obligations or be subject to penalties or other sanctions.

Changes to currently applicable laws and state and federal healthcare
reform measures that may be adopted in the future may result in additional reductions in Medicare and other healthcare funding and otherwise
affect the prices we may obtain for any product candidates for which we may obtain regulatory approval or the frequency with which any
such product candidate is prescribed or used.

Because we have multiple programs and product candidates under
development and are pursuing a variety of target indications and treatment modalities, we may expend our limited resources to pursue a
particular product candidate and fail to capitalize on development opportunities or product candidates that may be more profitable or
for which there is a greater likelihood of success.

We have two subsidiaries and expect to have multiple subsidiaries with
their own drug development plans, all of which will compete for financial resources to advance their development and commercialization.
Due to our constrained financial and personnel resources, we will likely be unable to fund all of those opportunities. For example, under
our current budget, our development plans focus on Darnatein’s DRT 101 drug candidate but not DRT 102. As a result, we may need
to postpone or cancel the pursuit of potential target conditions or product candidates that may later prove to have higher commercial
potential compared to those we actually fund.

Our investments in ongoing and upcoming research and development programs
might not yield any commercially viable candidates in the future. In addition, we may fail to accurately assess the commercial potential
or target market for a particular product candidate leading us to relinquish valuable rights to that candidate through collaborations,
licensing, or royalty arrangements, even when it would have been more advantageous for us to retain exclusive development and commercialization
rights.

We plan to license or acquire early