Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 144

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 144
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, 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 -partypayors, such as Medicare and Medicaid programs and managed care organizations, and others in the medical community. In addition, the availability of coverage by 74 third -partypayors 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 -partycoverage 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 -partypayors do not provide coverage and adequate reimbursement levels for any products we commercialize, market acceptance and commercial success would be reduced. Coverage and reimbursement may be limited or unavailable for our product candidates, if approved, which could make it difficult for us to sell any product candidates profitably. Significant uncertainty exists as to the insurance coverage and reimbursement status of any products for which we may obtain regulatory approval. In the United States, sales of any products for which we may receive regulatory approval will depend, in part, on the availability of coverage and reimbursement from third -partypayors. Third -partypayors include government authorities such