Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 71

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 71
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 have no pharmaceutical product candidates approved for commercial sale
and our product candidates have not generated any revenue. Our approach to the discovery and development of product candidates from early
stage to drug launch is unproven, and we do not know whether we will be able to develop any products of commercial value. Except for a
few clinical stage candidates in our portfolio, most of our other candidates are in the preclinical stages of development and will require
additional preclinical studies and future clinical development as well as regulatory review and approval, which may not be granted. Since
we are still in preclinical and clinical development, we would need to receive regulatory approvals, gain access to sufficient commercial
manufacturing capacity and implement marketing efforts before we could begin generating revenue from product sales or arrange for a third
party to do so on our behalf.

The Company will likely incur significant operating losses for
the foreseeable future and may never achieve or maintain profitability.

We have never generated any operating profits and incurred operating
losses of KRW 784.7 million and KRW 14.8 billion for years ending 2022 and 2023, respectively, and operating
loss of KRW 15.9 billion for the year ending December 31, 2024. We have an accumulated deficit of KRW 28.18 billion as
of December 31, 2024. We are likely to continue to incur operating losses in the future. While our RMC subsidiary generated revenues of
KRW 4.38 billion and KRW 4.81 billion in the years ending December 31, 2023 and 2024, respectively, none of our other subsidiaries
have generated any revenues from product sales because none of their current product candidates have received marketing or other required
regulatory approvals anywhere in the world. We may never generate product revenue from the commercial sales of our pharmaceutical product
candidates or achieve profitability.

Our business is dependent on the success of our product candidates
that we advance into clinical trials and ultimately commercial distribution, which will require managing complex scientific, regulatory,
management, sales, licensing and other issues.

Our ability to execute on our business model and generate revenues
depends on a number of factors including our ability to:

●successfully develop new product candidates through our drug
development strategy and advance those product candidates into pre-clinical studies and clinical trials;

●successfully complete ongoing pre-clinical studies
and clinical trials and obtain