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Taiwan s Premier Biopharma and the future leader in Immuno ... · profit forecast and should not be...

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1 Taiwans Premier Biopharma and the future leader in Immuno-Oncology
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Page 1: Taiwan s Premier Biopharma and the future leader in Immuno ... · profit forecast and should not be interpreted to mean ... Competitive/Market Analysis ... α4 β4 β β3 Cer Cer

1

Taiwan’s Premier Biopharma

and the future leader in

Immuno-Oncology

Page 2: Taiwan s Premier Biopharma and the future leader in Immuno ... · profit forecast and should not be interpreted to mean ... Competitive/Market Analysis ... α4 β4 β β3 Cer Cer

2

Safe Harbor StatementThis 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.

Page 3: Taiwan s Premier Biopharma and the future leader in Immuno ... · profit forecast and should not be interpreted to mean ... Competitive/Market Analysis ... α4 β4 β β3 Cer Cer

3

Mission and History

Leadership

Unique Globo Series Platform – OBI-822

Competitive/Market Analysis

Business Strategy & Vision

Agenda

Page 4: Taiwan s Premier Biopharma and the future leader in Immuno ... · profit forecast and should not be interpreted to mean ... Competitive/Market Analysis ... α4 β4 β β3 Cer Cer

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Corporate Introduction

Headquarters Taipei, Taiwan

Founded 29 April 2002

Subsidiaries OBI Pharma USA, Inc.OBI Pharma (HK) LimitedOBI Pharma (Shanghai) Limited

Funds Raised 23 Mar NT$ 6.2B (approx US$ 200M)

Market Capitalization Approx NT$ 60B or US$ 1.9B

Chair Michael Chang, PhD

General Manager Amy Huang

Headcount 84 Total (R&D 54)

Website www.obipharma.com/en

Page 5: Taiwan s Premier Biopharma and the future leader in Immuno ... · profit forecast and should not be interpreted to mean ... Competitive/Market Analysis ... α4 β4 β β3 Cer Cer

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OBI Value EvolutionOBI-822

IND US, HK

Dificid wins TFDA

priority review &

exemption from

local BSE

OBI wins Biotech

Industry Award

OBI-822 license movedto OBI

OBIspun-off

OBI-833OBI-868

in-licensed

Foundedas a

wholly-owned

subsidiary of Optimer

Pharma

822-001 P2/P3

trial begins

OBI received

New DrugDeveloper

designationfrom MOEA

Dificid Taiwan market rights

granted

2002 2009 2010 2011 2012 2013 2014822-001

trial entersP3 in

Taiwan

OBI-822IND

Korea,India

OBI-822selectedfor ECFAPioneerProgram

OBI goespublic

Dificid NDA

approval

OBI-822InitiatesOvarian

P2

OBI-868co-developpartnershipMOU signed

OBI-868prototypedeveloped

US Team, China Team

recruited

OBI wins Biotech

Industry Award

822-001enrollmentcompleted

OBI-888pre-clinical

studybegins

OBI-888clone

selectioncompleted

DificidReimburse-

mentapproval

OBI-833IND US

FDAsubmission

NOTE: GREEN

are Corporate

ORANGE are Portfolio

BOLD ORANGE relate to

Page 6: Taiwan s Premier Biopharma and the future leader in Immuno ... · profit forecast and should not be interpreted to mean ... Competitive/Market Analysis ... α4 β4 β β3 Cer Cer

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Mission and History

Leadership

Unique Globo Series Platform – OBI-822

Competitive/Market Analysis

Business Strategy & Vision

Agenda

Page 7: Taiwan s Premier Biopharma and the future leader in Immuno ... · profit forecast and should not be interpreted to mean ... Competitive/Market Analysis ... α4 β4 β β3 Cer Cer

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Michael Chang, PhD

Founder & Chair

Youe-Kong Shue, PhDVice Chair & Principal Global Clinical Operations & Planning

Amy Huang

General Manager

Global Visionary Leadership

Page 8: Taiwan s Premier Biopharma and the future leader in Immuno ... · profit forecast and should not be interpreted to mean ... Competitive/Market Analysis ... α4 β4 β β3 Cer Cer

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Tony YuChief 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

Page 9: Taiwan s Premier Biopharma and the future leader in Immuno ... · profit forecast and should not be interpreted to mean ... Competitive/Market Analysis ... α4 β4 β β3 Cer Cer

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Mitch Che

Chief Operations Officer USA

Joanna Meng

Chief Operations Officer Greater China

Kevin P PoulosChief Commercial Officer

Richard Tseng

VP Quality Assurance

CT Wang

Finance Director

Edward HsiehCMC Director

Highly Experienced Management

Page 10: Taiwan s Premier Biopharma and the future leader in Immuno ... · profit forecast and should not be interpreted to mean ... Competitive/Market Analysis ... α4 β4 β β3 Cer Cer

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Mission and History

Leadership

Unique Globo Series Platform – OBI-822

Competitive/Market Analysis

Business Strategy & Vision

Agenda

Page 11: Taiwan s Premier Biopharma and the future leader in Immuno ... · profit forecast and should not be interpreted to mean ... Competitive/Market Analysis ... α4 β4 β β3 Cer Cer

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OBI is the onlycompany with a broad

“Globo Series” portfolioin late stage development

Globo Series: Globo H, SSEA-3, SSEA-4

Page 12: Taiwan s Premier Biopharma and the future leader in Immuno ... · profit forecast and should not be interpreted to mean ... Competitive/Market Analysis ... α4 β4 β β3 Cer Cer

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Globo Series: New Era in Cancer Therapy

Breast Cancer Tissue Biopsy

Globo H

SSEA-4

Cerββ4α4

β3

Cer

Cerβ3

α2Cer

α3Cer

SSEA-3

globoside

Gb3Cer

Sialic AcidFuc GalNAcGalGlc

60-80%expression

60%expression

90%expression

Page 13: Taiwan s Premier Biopharma and the future leader in Immuno ... · profit forecast and should not be interpreted to mean ... Competitive/Market Analysis ... α4 β4 β β3 Cer Cer

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Broad Coverage of Breast Cancer Biomarkers

ER/PR80%

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 Series60~80%

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Revolution of Cancer TherapyUse 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. 1432-1433PRN; Reuters; Andrew Baum, Citi Head of Global Healthcare; the Associated Press

Great Impact in ScienceScience Magazine Breakthrough

of the Year 2013Tang Prize: Cancer Immunotherapy

High ExpectationsPredicted 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

3%

60%

$35 billion a year by

2023

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Preclinical Indication Pre-Clin P1 P2 P3 NDA

Core ProductsInfectious Disease

Dificid®

fidaxomicinCDAD

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

LinkerGlobo 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

Page 18: Taiwan s Premier Biopharma and the future leader in Immuno ... · profit forecast and should not be interpreted to mean ... Competitive/Market Analysis ... α4 β4 β β3 Cer Cer

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OBI-822/821Double-blind, Randomized

Controlled Trial Phase 2/3 of Active Immunotherapy with Globo H-KLH

in Subjects with MetastaticBreast Cancer

Enrollment target reachedon 21 July 2014

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THANK YOU!www.obipharma.com/en


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