1 Taiwan s Premier Biopharma and the future leader in Immuno-Oncology
Safe Harbor Statement This presentation contains certain forwardlooking statements. These forward-looking statements may be identified by words such as believes, expects, anticipates, projects, intends, should, seeks, estimates, future or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others: 1 pricing and product initiatives of competitors; 2 legislative and regulatory developments and economic conditions; 3 delay or inability in obtaining regulatory approvals or bringing products to market; 4 fluctuations in currency exchange rates and general financial market conditions; 5 uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products; 6 increased government pricing pressures; 7 interruptions in production 8 loss of or inability to obtain adequate protection for intellectual property rights; 9 litigation; 10 loss of key executives or other employees; and 11 adverse publicity and news coverage. OBI Pharma cautions that this foregoing list of factors is not exhaustive. There may also be other risks that management is unable to predict at this time that may cause actual results to differ materially from those in forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. OBI undertakes no obligation to update publicly or revise any forward-looking statements. Any statements regarding earnings growth is not a profit forecast and should not be interpreted to mean that OBI s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed published earnings or earnings per share forecasts of OBI Pharma, Inc. 2
Agenda Mission and History Leadership Unique Globo Series Platform OBI-822 Competitive/Market Analysis Business Strategy & Vision 3
Headquarters Corporate Introduction Taipei, Taiwan Founded 29 April 2002 Subsidiaries OBI Pharma USA, Inc. OBI Pharma (HK) Limited OBI Pharma (Shanghai) Limited Funds Raised 23 Mar NT$ 6.2B (approx US$ 200M) Market Capitalization Approx NT$ 60B or US$ 1.9B 4 Chair Michael Chang, PhD General Manager Amy Huang Headcount 84 Total (R&D 54) Website www.obipharma.com/en
OBI Value Evolution 2002 2009 2010 2011 2012 2013 2014 Founded as a whollyowned subsidiary of Optimer Pharma OBI-822 license moved to OBI OBI spun-off OBI-833 OBI-868 in-licensed 822-001 P2/P3 trial begins OBI received New Drug Developer designation from MOEA Dificid Taiwan market rights granted OBI-822 IND US, HK Dificid wins TFDA priority review & exemption from local BSE OBI wins Biotech Industry Award 822-001 trial enters P3 in Taiwan OBI-822 IND Korea, India OBI-822 selected for ECFA Pioneer Program OBI goes public Dificid NDA approval OBI-822 Initiates Ovarian P2 OBI-868 co-develop partnership MOU signed OBI-868 prototype developed US Team, China Team recruited OBI wins Biotech Industry Award 822-001 enrollment completed OBI-888 pre-clinical study begins OBI-888 clone selection completed Dificid Reimbursement approval OBI-833 IND US FDA submission 5
Agenda Mission and History Leadership Unique Globo Series Platform OBI-822 Competitive/Market Analysis Business Strategy & Vision 6
Global Visionary Leadership Michael Chang, PhD Founder & Chair Youe-Kong Shue, PhD Vice Chair & Principal Global Clinical Operations & Planning Amy Huang General Manager 7
World-class R&D Experience Tony Yu Chief Science Officer Nathan Chen Chief Medical Officer & Head of Global Medicines Development Phoebe Yu VP Translational Science David Hallinan VP Regulatory Affairs JS Lai Senior Director R&D Jon Liao Medical Affairs Director 8
Highly Experienced Management Mitch Che Chief Operations Officer USA Joanna Meng Chief Operations Officer Greater China Kevin P Poulos Chief Commercial Officer Richard Tseng VP Quality Assurance CT Wang Finance Director Edward Hsieh CMC Director 9
Agenda Mission and History Leadership Unique Globo Series Platform OBI-822 Competitive/Market Analysis Business Strategy & Vision 10
OBI is the only company with a broad Globo Series portfolio in late stage development 11 Globo Series: Globo H, SSEA-3, SSEA-4
Globo Series: New Era in Cancer Therapy α4 β3 β4 β Cer Gb3Cer Cer globoside 60% expression Breast Cancer Tissue Biopsy α2 α3 β3 SSEA-3 Globo H Cer Cer Cer 60-80% expression 90% expression SSEA-4 12 Glc Gal Fuc GalNAc Sialic Acid
Broad Coverage of Breast Cancer Biomarkers Globo Series ER/PR 60~80% 80% SOURCES: GlobalData; Chang et al. Proc Natl Acad Sci U S A. 2008 Aug 19;105(33):11667-72. Lou et. al., Proc Natl Acad Sci U S A. 2014 Feb 18;111(7):2482-7 13
Cancer Immuno-therapy: A Major Breakthrough in Cancer Therapy Revolution of Cancer Therapy Use of patient s own immune system to fight cancer cells Optimal anti-cancer efficacy Extended therapeutic effect Great Impact in Science Science Magazine Breakthrough of the Year 2013 Tang Prize: Cancer Immunotherapy High Expectations Predicted to be bestselling-cancer drugs by CitiBank Estimated NTD >10 trillion annual sales by 2023 14 COVER IMAGE: Science. Vol. 342 no. 6165 pp. 1432-1433 PRN; Reuters; Andrew Baum, Citi Head of Global Healthcare; the Associated Press
Cancer Immunotherapy: Most Important Advancement in Medical History 100% 90% 80% 70% 60% 50% 60% $35 billion a year by 2023 40% 30% 20% 15 10% 0% 3% Today Tomorrow SOURCES: PRN; Reuters; Andrew Baum, Citi Head of Global Healthcare; the Associated Press
Preclinical Indication Pre-Clin P1 P2 P3 NDA Core Products Infectious Disease Dificid fidaxomicin Cancer CDAD OBI Pipeline OBI-822 OBI-822 OBI-833 OBI-888 Breast cancer Ovarian cancer Epithelial cancers Epithelial cancers Non-core Products OBI-858 OBI-868 16 Cosmetics, Migraine Cancer Diagnostics
Introducing OBI-822: A Novel Active Immunotherapy for Cancer KLH Globo H Linker OBI-822: Innovative Glycoprotein Fully synthetic glycoprotein Tumor antigen (Globo H) + protein carrier Induced a robust antibody response Co-injected 821 + OBI-821: Potent Adjuvant Saponin-based adjuvant Increases the antigenic response Induces IgG & IgM targeting Globo Series 17
OBI-822/821 Double-blind, Randomized Controlled Trial Phase 2/3 of Active Immunotherapy with Globo H-KLH in Subjects with Metastatic Breast Cancer Enrollment target reached on 21 July 2014 20
38 THANK YOU! www.obipharma.com/en