Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 905

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 905
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 3 trials before possible regulatory approval in the US market. AF then estimated costs relating to the development and sale of each of its drug candidates in order to derive EBITDA, after tax operating profit and free cash flow estimates for each drug candidate assuming each of its product candidates obtained regulatory approval and were introduced into the market. The resulting free cash flow estimates were then probability-adjusted and thereafter combined to arrive at the financial projections of adjusted free cash flows of Vaximm and Darnatein, the two main subsidiaries of OSR in the drug R&D business. The probability adjustments reflected the appropriate probabilities for the therapeutic area/modality and disease indication (12.4% for immune-oncology, 8.98% for regenerative medicine, and 9.4% for protein modality) to account for clinical, manufacturing and regulatory (including FDA) approval risks in bringing a new drug candidate to market. It is unlikely that all of OSR’s current programs will obtain FDA approval or be introduced into the market within the projected timeframes, but the probability-weighted adjustments in the rNPV analysis take into account the probability of the product candidates coming to market. It should be noted that if some or all of OSR’s current product candidates do not obtain FDA approval or other regulatory approval, or are not introduced into the market because of technical, competitive, and other impediments, its actual free cash flow will vary from the financial projections. While OSR’s financial projections forecast that OSR may obtain profitability in the future, to the extent its programs are delayed, fail to obtain FDA approval, or are not introduced to the market, the projected financial results will be less likely to be achieved and it will take longer for OSR to obtain profitability, if it does at all. However, OSR has a portfolio of multiple programs, not all of which have to obtain FDA approval or be introduced to the market in order for OSR to be profitable or to derive a positive exit transaction with respect to a subsidiary company. The probability adjustments made by AF to its financial projections of OSR’s free cash flow are intended to account for these factors and we considered the projections and analyses conducted by AF in our deriving own assessment and valuation outcomes. Annex I-9 Determination of the Probabilities of Success Most of the projects being developed by subsidiaries of OSR relate to novel therapeutical approaches, primarily in the field of immune-oncology and regenerative medicine. Based on the BIO (Biotechnology Innovation Organization) meta-study conducted between