Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 142

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 142
---
 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. OSR Holdings 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 784.6 million and KRW 12.29 billion for years ending 2022 and 2023, respectively, and operating losses of KRW 4.8 billion and 8.8 billion for the six months ending June 30, 2023 and 2024, respectively. We have an accumulated deficit of KRW 21.14 billion as of June 30, 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 profits of KRW 78.1 million in 2023, and KRW 1.98 billion and KRW 2.42 billion in the six months ending June 30, 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 -clinicalstudies and clinical trials; 73 •successfully complete ongoing pre -clinicalstudies and clinical trials and obtain regulatory approvals for our current and future product candidates; •attract and retain experienced management and advisory teams; •add operational, financial and management information systems and personnel, including personnel to support clinical, pre -clinicalmanufacturing and planned future commercialization