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Taiwan’s Premier Biopharma and the future leader in
Immuno-Oncology
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Safe Harbor Statement This presentation contains certain forward-looking 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.
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Mission and History
Leadership
Unique Globo Series Platform – OBI-822
Competitive/Market Analysis
Business Strategy & Vision
Agenda
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Corporate Introduction Headquarters 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$ 74B or US$ 2.3B
Chair Michael Chang, PhD General Manager Amy Huang Headcount 100 Total (R&D 65) Website www.obipharma.com/en
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OBI Value Evolution OBI-822
IND US, HK
Dificid
wins TFDA priority
review & exemption
from local BSE
OBI wins Biotech
Industry Award
OBI-822 license moved to OBI
OBI-833 OBI-868
in-licensed
OBI spun-off
Founded as a
wholly- owned
subsidiary of Optimer
Pharma
822-001 P2/P3
trial begins
Dificid Taiwan market rights
granted
OBI received
New Drug Developer
designation from MOEA
2002 2009 2010 2011 2012 2013 2014 822-001
trial enters P3 in
Taiwan
OBI-822 IND
Korea, India
OBI-822 selected for ECFA Pioneer Program
Dificid
NDA approval
OBI goes
public
OBI-822 Initiates Ovarian
P2
OBI-868 co-develop partnership MOU signed
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
Reimburse- ment
approval
OBI-833 IND US
FDA submission
2015 822-001
Final Data
Cut-off
833-001 IND
approval
Dificid Licensing
to MSD
Uplisting raises
US$ 200M
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Mission and History
Leadership
Unique Globo Series Platform – OBI-822
Competitive/Market Analysis
Business Strategy & Vision
Agenda
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Michael Chang, PhD Founder & Chair
Youe-Kong Shue, PhD Vice Chair & Principal Global Clinical Operations & Planning
Amy Huang General Manager
Global Visionary Leadership
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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
World-class R&D Experience
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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
Highly Experienced Management
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Mission and History
Leadership
Unique Globo Series Platform – OBI-822
Competitive/Market Analysis
Business Strategy & Vision
Agenda
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OBI is the only company with a broad
“Globo Series” portfolio in late stage development
Globo Series: Globo H, SSEA-3, SSEA-4
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Globo Series: New Era in Cancer Therapy
Breast Cancer Tissue Biopsy
Globo H
SSEA-4
Cer β β4 α4
β3 Cer
Cer β3
α2 Cer
α3 Cer
SSEA-3
globoside
Gb3Cer
Sialic Acid Fuc GalNAc Gal Glc
60-80% expression
60% expression
90% expression
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Broad Coverage of Breast Cancer Biomarkers
ER/PR 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
Globo Series 60~80%
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Revolution of Cancer Therapy Use of patient’s own immune system to fight
cancer cells Optimal anti-cancer efficacy Extended therapeutic effect
COVER IMAGE: Science. Vol. 342 no. 6165 pp. 1432-1433 PRN; Reuters; Andrew Baum, Citi Head of Global Healthcare; the Associated Press
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
Cancer Immuno-therapy: A Major Breakthrough in Cancer Therapy
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Cancer Immunotherapy: “Most Important Advancement in Medical History”
SOURCES: PRN; Reuters; Andrew Baum, Citi Head of Global Healthcare; the Associated Press
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Today Tomorrow
10%
60%
$35 billion a year by
2023
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Preclinical Indication Pre-Clin P1 P2 P3 NDA
Core Products Infectious Disease
Dificid®
fidaxomicin CDAD
Cancer
OBI-822 Breast cancer
OBI-822 Ovarian cancer
OBI-833 Epithelial cancers
OBI-888 Epithelial cancers
Non-core Products
OBI-858 Cosmetics, Migraine
OBI-868 Cancer Diagnostics
OBI Pipeline
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Induces IgG & IgM targeting Globo Series
KLH
Linker Globo H
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
Introducing OBI-822: A Novel Active Immunotherapy for Cancer
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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
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OBI-822/821 Novel Immuno-Oncology therapy with exceptional benefits
1st-in-Class Targets “Globo Series” in multiple cancers
Impressive P1 data
Safe Long-term survival
Specific Targets Globo Series antigens No effect on healthy normal cells
Better Quality of Life
Few adverse events Infrequent dosing
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Blockbuster Potential for OBI-822
Monotherapy
Combination Therapies Current Therapy: Hormone therapy, Chemotherapy, etc. Emerging Therapy: Checkpoint inhibitors PD-1, CTLA-4, etc.
Maintenance Therapy
Theranostic Approach
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Evolution of OBI’s Carbohydrate Synthesis Technology OPopS™ & Proprietary Enzymatic Synthesis
Barrier to Carbohydrate-based
Drug Discovery
Glycal Chemistry High COGS Inefficient synthesis
>100 Steps
Barrier to Efficient Large Scale
Manufacturing
OPopS™
Lower COGS Method for CTM
production
~50 Steps
Enzymatic Synthesis
Highly efficient Minimal purification
required Further reduced COGs Suitable for large scale
manufacture
4 Steps
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Summary: OBI-822 Innovative Immuno-Oncology Therapy
Fulfills high unmet medical and market needs
Global Series highly expressed on many tumors (up to 90%)
Impressive Phase I Safety & Efficacy results demonstrated
Better Quality of Life for Cancer patients & family
Strong IP protection
Carbohydrate synthesis technology: One-Pot Synthesis & Enzymatic Synthesis
Enrollment completed for a multinational P2/3 MBC Study (topline est. 1H 2016)
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Mission and History
Leadership
Unique Globo Series Platform – OBI-822
Competitive/Market Analysis
Business Strategy & Vision
Agenda
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2009 2010 2011 2012 2013 2014 2015F 2016F 2017F 2018F 2019F 2020F
Sales for Global Antineoplastic Agents are Increasing at A Faster Pace
SOURCE: GlobalData 2015
10% CAGR
12% CAGR
US$41B
US$72B
US$155B
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Unit: US$ billion Top Cancer Brands
Rank Brand Company Indication 2014 Sales
1 Rituxan Roche Non-Hodgkins lymphoma, Chronic lymphocytic leukemia 7.5
2 Avastin Roche Colorectal, Lung, Breast, Kidney, Ovarian 7.0
3 Herceptin Roche HER2+ Breast 6.9
4 Revlimid Celgene Multiple myeloma 5.0
5 Gleevec Novartis Chromic myeloid leukemia, Gastrointestinal stromal tumors 4.7
6 Velcade J&J/Takeda Multiple myeloma, Mantle cell lymphoma 3.1
7 Alimta Eli Lilly Non-small cell lung cancer 2.8
8 Zytiga J&J Prostate 2.2
9 Erbitux BMS/Merck Serono Colorectal, Head & Neck 1.9
10 Afinitor Novartis Breast 1.6 SOURCES: FirstWordPharma.com, Company reported data
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A Clear Unmet Medical Need Still Exists in Cancer Treatment
L M H
H
M
L
Efficacy
Safe
ty
Halaven
Herceptin
Tykerb
Faslodex
Ixempra
Abraxane
Perjeta
Afinitor
Avastin
Xeloda
Kadcyla
SOURCE: GlobalData, 2015 Drugs were evaluated for efficacy using available data from pivotal clinical trials. Primary endpoints, such as progressoin-free survival (PFS) and overall survival (OS) were assessed. Drug safety was evaluated based on available data from pivotal clinical trials and drug prescribing information as well as GlobalData's primary research with Key Opinion Leaders.
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Mission and History
Leadership
Unique Globo Series Platform – OBI-822
Competitive/Market Analysis
Business Strategy & Vision
Agenda
28
OBI Business Model for Success
Sufficient Fundraising
Strategic focus on high
potential markets
Strategic Partnership
Mergers & Acquisitions
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OBI’s Long-term Goal To be the Global Leader in Cancer Therapeutics by 2035
New Indications Lung, Ovarian, Pancreas, etc.
Product Acquisitions Complementary to
current pipeline
New Products OBI-833 OBI-868 OBI-888
Licensing Novel Technologies
New cancer therapeutic targets
30 Years 2015-2020 2021-2025 2026-2030 2031-2035
#1 Taiwan Biopharma
by 2025
Partnering Revenue &
Income (ex-territory)
Core Indications (OBI 822, OBI 833)
New Opportunistic
Indications (OBI 822, OBI 833)
OBI 888 Core Indications
Partnering Revenue & Income
Licensing/M&A New targets pipeline &
complementary products
OBI Pharma aspires to be… Leading Global Cancer Pharma
by 2035
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THANK YOU! www.obipharma.com