TaiGen Biopharmaceuticals Holdings Ltd. 太景 *-KY (4157.TWO) December, 2016

Transcription

1 TaiGen Biopharmaceuticals Holdings Ltd. 太景 *-KY (4157.TWO) December, 2016

2 Safe Harbor Statement This presentation is prepared by TaiGen Biopharmaceuticals Holdings Ltd. ( TaiGen ) and includes forward-looking statements about TaiGen and its business, including but not limited to statements regarding drug discovery, research and clinical development, regulatory approval processes, market opportunities and commercialization. These forward looking statements are subject to risks and uncertainties and may cause actual events or results to differ materially from our current expectations. Please refer to our prospectus for full disclosure of risks before making an investment decision. This presentation is copyright protected and cannot be reproduced without written permission from TaiGen. Restricted & Confidential 2

3 Company Highlights Founded in 2001 in Taipei and backed by blue-chip investors including MPM Capital and Taiwan National Development Fund Led by seasoned US-trained management team with pharma experience NCE pioneer in Greater China with an integrated R&D platform and proven track record Pipeline include first-in-class or best-in-class products to treat cancer or infectious disease First product, Taigexyn, launched in Taiwan in Dec Received China CFDA market approval in Jun. 2016, launched in mainland China on Oct.23,2016 Publicly listed in Taipei Exchange (TPEx) since Jan Market capitalization of ~US$ 670M (as of Nov.30, 2016) Number of employees: 80 ; 75% in R&D with Masters, PhD, or MD degrees Restricted & Confidential 3

4 Seasoned Management Team Each With 20+ Years in Related Fields Name / Title Ming-Chu Hsu, Ph.D. Founder, Chairman, and CEO Phillip Huang Chief Commercial Officer in Asia Peter Tsao, Ph.D. VP Corporate Development Chu-Chung Lin, Ph.D. Senior Director, Discovery Research & Chemical Development Edward Kuo, M.D. VP Clinical Development Richard Lu VP Finance Department Experiences Director, Oncology and Virology Research, Roche Director China Marketing & Sales, Takeda Senior Director, Repros Therapeutics Director BD, Mitsubishi Tanabe, Tanabe Seiyaku Director, Medicinal Chemistry, TaiGen Medical Director, Boehringer-Ingelheim, Pfizer, BMS VP, Chien Kuo Construction Co., Ltd. VP, Taiwan Prosperity Chemical Co., Ltd. Restricted & Confidential 4

5 Reputable Gov t and Private Institutions Form a Strong Shareholders and BOD Bases 9 BOD members (3 independent Directors included) As of Apr. 19, 2016 Restricted & Confidential 5

6 TaiGen s Focus is NCEs The Highest Margins in the Value Curve High Technological and Marketing Complexity The Pharmaceutical Industry s Value Curve Intermediates/ bulk substances Commodity generics Conventional dosage forms Valueadded & branded generics Over-thecounter and new drug delivery systems TaiGen s Focus: New chemical entity drug discovery & development Low Gross Margin 2%-12% 12%-20% 20%-30% 30%-40% 40%-60% 60%-100% Source: Harvard Business Review, March 2000 Restricted & Confidential 6

7 Over 300 Patents Granted for Global IP Protection Providing market exclusivity and out-licensing opportunities As of November 30, 2016 Product Type of Patent Patents Granted Composition of Matter 45 Nemonoxacin (Antibiotic) Burixafor (Stem Cell Mobilizer) Hepatitis C Virus Protease Inhibitor TG-2349 (HCV Protease Inhibitor) Salt Form 54 Process 46 Use 23 Formulation 31 Composition of Matter / Use 79 Composition of Matter / Use 96 Total 374 Restricted & Confidential 7

8 Highly Differentiated NCEs in the Pipeline Restricted & Confidential 8

9 Taigexyn NCE Antibiotic for Drug-resistant Infections Novel, non-fluorinated quinolone, broad-spectrum antibiotic with global IP protection until 2030 Launched in Taiwan in Dec Received China FDA market approval on Jun. 8, Launched in mainland China on Oct. 23, 2016 Received QIDP and Fast Track designations from US FDA Taigexyn was out-licensed to Zhejiang Medicine in mainland China. Out-licensed to R-Pharm for Russia, Commonwealth Independent States and Turkey markets, to Productos Científicos for Latin American markets. Conducting combined phase 3 trials of intravenous formulation in Taiwan and China; completed patient enrollment and achieved the primary end point in China. Continue to explore and expand partnerships in other territories 9

10 Taigexyn Out -Licensed over 32 Countries Worldwide As of November 30, 2016 Licensee Territory Country Zhejiang Medicine Mainland China 1 R-Pharm Russian Federation, Turkey and Commonwealth Independent States (Include Azerbaijan Armenia Belarus Kazakhstan Kyrgyzstan Moldova Turkmenistan Tajikistan Uzbekistan Ukraine Georgia ) 13 Holding Distribution Taiwan 1 Productos Científicos Mexico, Brazil and Latin American Market (include Colombia Peru Uruguay Paraguay Bolivia Venezuela Argentina Chile Costa Rica Honduras Nicaragua Panama Guatemala El Salvador Ecuador ) 17 Total 32 Restricted & Confidential 10

11 Taigexyn - The first China FDA 1.1 drug NDA The first Class 1.1 new drug[1] developed by a Taiwanese company to receive market approval in mainland China The first new drug approval after the China FDA announced the requirement of self-inspection of drug clinical trial data in July 2015 Taigexyn will be marketed in mainland China by Zhejiang Medicine Co. through an exclusive marketing and manufacturing licensing agreement TaiGen will receive 7%-11% royalty based on the net annual sales of Taigexyn in mainland China [1] Class 1.1 means a NCE that has not been marketed anywhere in the world at the time of application for market approval in China Restricted & Confidential 11

12 Taigexyn Key Message to Prescribers Potent Superior activity against MRSA,VRSA, MDRSP, and PRSP Broad-spectrum Excellent activity for Gram +ve, Gram -ve, and atypical pathogens Low resistance Require mutations in three different bacterial genes Convenient Once-daily use Oral and IV available Effective Exceptional efficacy was shown in 3 CAP and 1 DFI trials Safe Excellent safety profile No cardio-side effect Restricted & Confidential 12

13 Chinese Pharmaceutical and Quinolone Market The Chinese pharmaceutical market is RMB 645 Billion (~US$100B) in 2015, the second largest in the world behind the U.S. Sales of antibiotics in 2015 is RMB 79.7 Billion (~US$13.3B) and account for almost 25% of the global consumption on antibiotics Quinolone is one of the top antibiotic classes with sales of RMB 6.4 Billion (~US$1 B) Price Per Day of Two Originator s Quinolones Avelox (Bayer) RMB / per day Cravit (Daiichi) RMB /per day Intravenous Formulation RMB 106 RMB Oral Formulation 25.1 RMB 12.1 RMB Restricted & Confidential 13

14 China Partner - Zhejiang Medicine Co. Achieved One of Top 5 Quinolone Sales in China Zhejiang Xinchang Medicine, TaiGen s partner in China, is marketing one of the top selling quinolone-lai Li Xin, in Chinese market. Top 5 Quinolone Sales in China 2015 Company Product Sales (RMB Million) Bayer Avelox 1,603 Yangzijiang Zuo Ke (Branded Levo) 1,342 Zhejiang Medicine Lai Li Xin (Branded Levo) 1,031 Daiichi Sankyo Cravit (Originator Levo) 544 Shuanghe Li Fu Xing (Branded Levo) 467 Restricted & Confidential 14

15 Burixafor Next Generation Stem Cell Mobilizer and Chemosensitizer Potent and selective CXCR4 antagonist that mobilize stem cells and cancer cells from the bone marrow into peripheral circulation. Target indications: Hematopoietic Stem Cell Transplantation (HSCT) Chemosensitization Completed phase 1, and two phase 2 studies in HSCT in US; a chemosensitization trial is on-going in China Global IP protection including US, EU, Japan, China until Restricted & Confidential 15

16 Burixafor Simplify Collection/Banking of Hematopoietic Stem Cells for HSCT Current Standard of Care requires 5-8 days of G-CSF and an average of 4 leukapheresis sessions Burixafor monotherapy Can be use alone in multiple myeloma patients to mobilize sufficient stem cells for hematopoietic stem transplantation Burixafor + G-CSF Lower total cost of hematopoietic stem cell transplantation (US$ K) Only two leukapheresis required Reduce hospital stay Reduce number of G-CSF injections and minimize bone pain Source: EBMT Restricted & Confidential 16

17 Metastatic Prostate Cancer Cells in the Bone Marrow 18 F-Fluoride PET Courtesy of Prof. K. Pienta J Nucl Med 47: 287 (2006) From J Clin Investigation 121:1298 Restricted & Confidential 17

18 Burixafor One Drug, Multiple Indications Autologous stem cell transplantation Completed two POC trials in multiple myeloma, NHL, HD in the US. Results suggest potential in reducing number of leukapheresis and hospital costs Got CTA in HSCT in China Chemosensitization in hematological malignancies Initiated chemosensitization in acute myeloid leukemia at the Hematological Institute in Tianjin Allogeneic stem cell transplantation Signed agreement with Cellex in Germany to initiate trials in allogeneic poor mobilizers. Potential to apply for orphan drug designation in US/EU. Chemosensitization in solid tumors Signed agreement with Johns Hopkins University Hospital for a pilot study in metastatic prostate cancer Restricted & Confidential 18

19 Burixafor Other Potential Indications Studies were performed in myocardial infraction model using mini-pigs ischemia Results showed that endothelial progenitors cell are being mobilized after administration of burixafor Significant improvement in LVEF (left ventricular ejection fraction) compared to the control group was observed Seeking partnerships to fully explore the potential Restricted & Confidential 19

20 Furaprevir Highly Effective & Affordable HCV Treatment Furaprevir is active against all six genotypes of Hepatitis C virus (HCV) and has the potential to reduce total treatment duration to 12 weeks or less. Phase 1/2a study was completed under IND with US FDA and results were presented at AASLD (late-breaking news) A Phase 2 study of Furaprevir in combination with peg-interferon and ribavirin for GT-1b has completed dosing in Taiwan. Selection of treatment durations was based on week 4 RVR results. 92% of subjects were qualified for 12- week total treatment duration, among them 91% achieved SVR12 Clinical trial authorization (Class 1.1) was submitted to China FDA in Apr. 2015, granted fast track priority review status in Apr. 2016, received Clinical Trial Authorization in Aug TaiGen has signed an agreement with YiChang HEC ChangJiang Pharmaceutical Co., is establishing a new company ( Newco ) in mainland China for the joint development, manufacturing, and commercialization of direct-acting antiviral agents (DAAs) for all-oral interferon-free treatments of chronic hepatitis C virus (HCV) infection in the Greater China region (mainland China, Taiwan, Hong Kong, and Macau) 20

21 TaiGen s Near-Term Goals and Long-Term Vision To expand indications of Taigeyxn in China and Taiwan To establish Taigeyxn partnerships in other territories To advance Burixafor into Phase 3 clinical development and expedite the path to commercialization Developing affordable, highly effective, and shorter HCV treatment regimens using Furaprevir as the anchor of cocktail therapy Utilizing TaiGen s NCE platform to develop a sustainable product pipeline Developing sales and marketing, manufacturing functions to become a fully integrated pharmaceutical company Restricted & Confidential 21