Company: OSRH
Filing Date: 2025-01-24
Form Type: S-4/A
Source: 0001213900-25-006139
Chunk: 900

Company: OSR Holdings, Inc.
Filing Date: 2025-01-24
Form: S-4/A
Chunk 900
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 is a common type of R&D subsidies in some countries and/or for some R&D field or indications (i.e., from foundations and patient associations). These future cash flows are converted to their present value equivalents using an estimated discount rate (or required rate of return). Annex I-8 The rNPV method relies on these same principles of the NPV method, and additionally involves certain risk adjustments which more closely reflect the inherent R&D and regulatory risks of drug development. A wealth of data in the biopharma area is made publicly available to track historical LOA (Likelihood of Approval) across the R&D fields (i.e., type of molecule, of indication, of regulatory designation). These LOAs allow to account for risks at each R&D step. For this, the expected cash flow for a given risk phase is multiplied by the probability of it occurring. The discount rate in the case of rNPV is lower than in the case of NPV, as here, the R&D and regulatory risks have already been factored in. In the case of biopharma innovation, there is typically no terminal value accounted for. However, the cash flows are computed, risk adjusted and discounted until the end of the patent-protection period of an asset. Engagement of AF The M&A Committee retained the Korean affiliate of a global accounting firm (“AF”) to prepare financial models based on the commercial potential of OSR’s pipeline drug candidates for Vaximm and Darnatein (based upon Target Product Profiles (TPPs) for each asset that were developed based upon the preclinical efficacy and safety that OSR and its subsidiaries have seen to date), to understand the potential levels of revenues that could be obtained if they obtained regulatory approval (including FDA approval) and were introduced into the market. AF provided estimates of revenues from each drug candidate using differing market penetration assumptions (from start to peak market shares) per each drug candidate. AF’s operating projection and the resulting rNPV models for the two drug R&D subsidiaries of OSR assumed all product candidates obtain FDA approvals (or the corresponding approvals in other countries’ markets) and are introduced into the market. OSR’s programs are either in the preclinical phase or in early PoC (proof-of-concept) clinical studies, and they will face clinical, manufacturing and regulatory hurdles as they progress through Phase 1, Phase 2 and Phase 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