台灣本土新藥開發商於資本市場募資與IPO的現況與挑戰-以P生技公司為例

Abstract

資本市場是衡量一個國家經濟發展繁榮程度的重要指標，也是發揮了促進產業發展和資金供給的雙重作用。 發行人透過資本市場渠道，募集未來研發和擴建所需的資金，然後將經營利潤分配給股東，這就是資本市場的機制。 醫藥是高度研發導向的產業。研發過程需要巨額資金和長期投資，並受到嚴格的政府法規監管。新藥從研發到獲准上市平均需要10-15年的時間。根據倫敦政治經濟學院所帶領的倫敦衛生與熱帶醫學院和 KU Leuven 聯合研究，2018-2019 年新藥上市成本中位數為 9.85 億美元，平均成本為 13 億美元，充分顯示醫藥開發是高風險、高報酬的產業。 目前位於興櫃市場的新藥開發商，其產品開發大多是於臨床I期或II期試驗階段，也就是在公司成立或擴張期，其初期天使投資或政府資助的資金，往往無法支持產品擴展到後續臨床III期以甚至到新藥上市階段。在此期間籌資是非常關鍵的，因為新藥開發商必須籌集更多的資金來維持公司未來的營運。 本研究透過質性訪談，訪問私募股權/創投公司的資深專業經理人員（買方）、資深投資銀行家（賣方）。同時也進行個案研究，針對已成功獲得美國FDA 新藥查驗登記批准上市多年，也順利在台灣IPO的 P公司(發行人)財務長進行深入訪談。 本研究對新藥開發商各階段發展的關鍵點如:領導人特質、團隊、營運計畫、技術、無形資產和商品授權及合作夥伴等六大項目進行採訪、檢查和確認。導出上述三方(買方、賣方及發行人端)，一致結論認為」「研發技術能力」和 「產品取得國際藥廠授權 」是新藥開發商羸得資本市場青睞，順利募資及IPO，持續完成臨床產品開發到取得藥證上市銷售，最重要的關鍵。

The capital market is a stimulator of industry growth and a key indicator of a country's economic development. In the basic mechanism of the capital market, the issuers raise funds, obtain sufficient funding for pipeline research & development (R&D) and future expansion, as well as distribute operating profits to shareholders. The pharmaceutical industry is a R&D intensive industry. The R&D process requires enormous capital and long-term investment and is subject to strict government regulatory oversight. On average, it takes 10-15 years to develop a new drug, from discovery to approval for marketing. According to a joint study by the London School of Hygiene and Tropical Medicine and KU Leuven, led by the London School of Economics and Political Science, the median cost of all new drugs launched in 2018-2019 was $985 million, with the mean cost at $1.3 billion. This is a very high-risk, high-profit industry. In the current emerging market, new drug developer’s products are primarily in clinical trial phase I or phase II, typically as the company is in early establishment or expansion periods. During these time periods, the initial angel investment or government grants are often insufficient to substantiate advancing the products from phase I and II to phase III, or to successfully enter the market. Therefore, successful fundraising is imperative during these periods, as new drug developers must raise adequate funds to support future operations. In this study, we conducted semi-structured interviews of multiple senior executives at private equity/venture capital companies (buyer) and senior investment bankers (seller). In addition, we conducted case study interviews with the chief financial officer of the case P company, which has successfully obtained FDA NDA approval and Taiwan IPO. Our interviews focused on several key domains that may potentially contribute to successful new drug development. These domains include (1) leadership, (2) teamwork & culture, (3) company business plan, (4) research and development, (5) intangible asset evaluation, and (6) product out-licensing and partnership. We obtained in-depth knowledge through guided and open-ended questions. We extracted the key information from these conversations and verified their accuracies. The study concluded that the new drug developers “R&D capability” and “out-licensing to international pharmaceutical companies” are two key pre-requisites before these developers can become attractive in the capital market, fundraise, achieve IPO, complete all clinical trial phases, and successfully launch the product in the market.