財團法人亞太金融研究發展基金會 Foundation of Pacific Basin Financial Research and Development Panel Session XVII. Capital Planning and Capital Market of Biotech Industry 創投(VC)與生技新藥製藥產業的相輔相成共生關係 Howard Lee Ph.D. 李 世 仁 博士 Easy Life Science Management, Inc. July 9, 2011 EasyLife 1 SUMMARY Bioindustry is a globally recognized main stream growing industry Venture Capital Fund vs. Knowledge Based Industry Direct Financing Products/Capital Market Analysis Taiwan Healthcare Industry Opportunity EasyLife 2 Worldwide consensus: Knowledge-based Industries Early 2009 US - Barack Obama: bioindustry、new energy、 internet-communication、infrastructure Taiwan - 劉 兆 玄: bioindustry、green energy、 telecommunication、infrastructure EasyLife 3 Executive Yuan: six growing focuses in knowledge-based Industry 生技起飛 biotechnology 醫療照護 healthcare 精緻農業 agriculture 綠色能源 green energy 文化創意 culture 觀光拔尖 sightseeing EasyLife 4 Biotechnology Index Chart in past 10 yrs *BTK: AMEX Biotech Index, IXIC: NASDAQ Index, NBI: NASDAQ Biotech Index, DJI: Dow Jones Index EasyLife Source: Yahoo! Inc. 5 SUMMARY Bioindustry is a globally recognized main stream growing industry Venture Capital Fund vs. Knowledge-Based Industry Direct Financing Products/Capital Market Analysis Taiwan Healthcare Industry Opportunity EasyLife 6 Innovative Source vs. Biotech Industry Government University Research Institute Hospital Non-profit organization Supply 85% innovative sources Cradle of biotech industry Death of Valley Professional supports:incubation center、tech transfer dept.、evaluation corp. VC、Buyout fund、PE fund Biotech Industry EasyLife Profit organization Connection w/ financial industry Connection w/ capital market Connection w/ global biotech industry cluster 7 Across Death of Valley Firms play a key role in creating value from biomedical ideas by finding opportunities for value creation and raising funding based on the promise of value capture EasyLife 8 Venture Capital Fund vs. Knowledge Based Industry EasyLife Venture Capital Venture capital may be regarded as an equity investment where investors expect significant capital gains in return for accepting the risk they may lose all their equity EasyLife 10 VC Fund vs. Direct Financing Direct Financing vs. Indirect Financing Direct Financing (involve in corp. management) - Equity Investment Indirect Financing (NOT involve in corp. management) - Loan、Grant、Tax Incentive UniMed 11 SUMMARY Bioindustry is a globally recognized main stream growing industry Venture Capital Fund vs. Knowledge-Based Industry Direct Financing Products/Capital Market Analysis Taiwan Healthcare Industry Opportunity EasyLife 12 Capital Market and Related Players Private Market Public Offering Market IPO VC [VC Fund] [Investment Bank] [Hedge Fund] M&A , [Buy-out Fund] EasyLife Public Security Market Follow-on PIPEs Debt [Mutual Fund] Consolidation [Private Equity Fund] 13 Corp. vs. Capital Market BIO€ QUITY Money Distribution in Capital Market Mutual Funds (Hedge Funds) Private Equity Funds Buy-out Funds VC Funds EasyLife (Angel Fund) 14 Capital Market Status decides Industry Type Large long term bio fund Drug Industry Small short term bio fund Medical Device Industry Small flexible Investment money diversified small and medium enterprise in biotech industry EasyLife 15 Drug vs. Medical Device High risk, high return Need long term money Need large smart money IPO vs. M&A Biotech Drug Development HIGH Total Return LOW Medical Devices LOW EasyLife Risk “UnMet Need” Low risk, low return Early liquidity High IRR Early distributions IPO vs. M&A HIGH 16 Drug Development and Approval Process •It takes 11 years on average for an experimental drug to travel from lab to medical chest. •Only 5 in 5,000 compounds screened in preclinical testing make it to human testing. •1 of these 5 tested in people is approved. Preclinical Phase I Phase II Phase III Testing Years 3.5 1 2 3 Test Laboratory 20 to 80 100 to 300 1,000 to 3,000 Population and Animal Healthy Volunteers Patient Volunteers Patient Volunteers Studies Purpose Access safety Determine Evaluate Verify effectiveness, and biological F safety and effectiveness. monitor adverse activity I dosage Look for side reactons from L effects long-term use E Expedited review: Phase II and III combined to shorten approval I N process on new medicines for serious D and life-threatening diseases. % of all new drugs that pass EasyLife 70% of INDs 33% of INDs 27% of INDs FDA F I L E 1 Approval Phase IV Total = 10.5 Post-marketing safety monitoring Review Process Large-scale manufacturing Distribution N D A Education 20% of INDs 17 Taiwan Biotech Industry : small & medium enterprise with flexibility 食品生技 27% 農業生技 13% 環境生技 5% 特化生技 6% 生技服務業 13% 生物製劑 36% 2009 Taiwan Biotech Corp. Allotment EasyLife Source:MOEA經濟部生物技術與醫藥工業發展推動小組 2010 18 Taiwan TSE「Biotech Healthcare」Sector-18 Listed Pharma:中化製藥(資本額NT$29.81億元)、永信藥品(資 本額NT$25.37億元) 、生達製藥、杏輝藥品、旭富、懷特 新藥(資本額NT$9.42億元)、台耀、中化生技 Reagent:亞諾法 Drug Store Channel:美吾華 Functional Food:葡萄王、景岳 Medical Device/Channel:五鼎、東貿、雃博、華廣 Exercise Instrument:必翔、喬山 * Daily Trading Volume:200k~4,000k shares EasyLife 19 Taiwan OTC「Biotech sector」- 33 Listed Pharma/Functional Food:東洋藥品、濟生、晟德、 南光、中天、天良、健喬信元、生泰、永日、杏昌、德英 Healthcare Service:盛弘、大學光學、訊聯、KY馬光 CRO/Reagent:進階、聯上 Marketing Channel/Functional Food:弘如洋、友華、 加捷、天騵 Medial Device/Channel:精華、寶利徠、合世、百略 、紅 電、邦拓、聯合骨科、晶宇、太醫、優盛、泰博、曜亞 * Daily trading volume:50k~4,000k shares EasyLife 20 SUMMARY Bioindustry is a globally recognized main stream growing industry Venture Capital Fund vs. Knowledge Based Industry Direct Financing Products/Capital Market Analysis Taiwan Healthcare Industry Opportunity EasyLife 21 台灣生技起飛鑽石行動方案 Taiwan Bioindustry Take-off Action Plan Executive Yuan approved on 10/7/2009 SIC BVC 資料來源:行政院科技顧問組 22 台灣生技起飛鑽石行動方案 Taiwan Bioindustry Take-off Action Plan Direct and Proactive - BVC (生技創投基金) Indirect and Passive - TFDA - SIC (生技整合育成中心) - Integration of research Institutions (經濟部產業化研發中心) EasyLife 23 Global Pharmaceutical Market Forecast Sales North America 41% Europe 27% Emerging Markets 13% Japan 11% Rest of World 8% * Russia 2013 estimate based on September 2008 forecast Source: IMS Health, Market Prognosis Taiwan Bioindustry Opportunity Taiwan is in critical position in between three largest markets in the world US Taiwan China EasyLife Japan 25 Howard Lee, Ph.D. howardlee@silverbm.com EasyLife