Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 319

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 319
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 be able to generate pharmaceutical product revenue.

We have no internal sales, marketing or distribution capabilities for
pharmaceutical products (one subsidiary markets and sells medical products and devices), nor have we commercialized a product. If any
of our pharmaceutical product candidates ultimately receive regulatory approval, we expect to establish either an internal or external
pharmaceutical marketing and sales organization with technical expertise and supporting distribution capabilities to commercialize each
such product in applicable major markets, which will be expensive and, to the extent we establish such an organization in-house, time
consuming. We have no prior experience as a company in the marketing, sale and distribution of pharmaceutical products and there are significant
risks involved in establishing or managing a sales organization, including our ability to hire, retain and incentivize qualified individuals,
generate sufficient sales leads, provide adequate training to sales and marketing personnel and effectively manage a geographically dispersed
sales and marketing team. Any failure or delay in the development of our internal or external pharmaceutical sales, marketing and distribution
capabilities would adversely impact the commercialization of these products. If we choose to collaborate with third parties that have
direct sales forces and established distribution systems, either to augment our own sales force and distribution systems or in lieu of
our own sales force and distribution systems, we may not be able to enter into collaborations or hire consultants or external service
providers to assist us in pharmaceutical product sales, marketing and distribution functions on acceptable financial terms, or at all.
In addition, our pharmaceutical product revenues and our profitability, if any, may be lower if we rely on third parties for these functions
than if we were to market, sell and distribute any pharmaceutical products that we develop ourselves. We likely will have little control
over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our pharmaceutical
products effectively. If we are not successful in commercializing our pharmaceutical products, either on our own or through arrangements
with one or more third parties, we may not be able to generate any future pharmaceutical product revenue and we would incur significant
additional losses.

Our investment strategy and future growth relies on a number
of assumptions, some or all which may not be realized.

Our strategy for investment and plans for future expansion are founded
upon a range of assumptions. These assumptions, particularly for our pharmaceutical product candidates, include considerations related
to the adoption of a specific therapy, the price at which the product candidate might be sold (or reimbursed by third party payors), the
occurrence