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1 Taiwan’s Premier Biopharma and the future leader in Immuno-Oncology

Taiwan’s Premier Biopharma and the future leader in Immuno ...EN)_53fj3G… · Breast cancer can also be classified according to the receptors present on the cancerous cells. \爀屲In

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Page 1: Taiwan’s Premier Biopharma and the future leader in Immuno ...EN)_53fj3G… · Breast cancer can also be classified according to the receptors present on the cancerous cells. \爀屲In

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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

簡報者
簡報註解
"2011 Taiwan Biomedical and Agricultural Industries Innovation and Excellence Ceremonies“ http://www.bic.searca.org/news/2011/sep/tai/22.html 2013 OBI won Taiwan “Venture Capital Star” The Best Investment Award http://www.obipharma.com/index.aspx?lang=eng&fn=news_content&no=10
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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%

簡報者
簡報註解
Breast cancer can also be classified according to the receptors present on the cancerous cells. In the majority of cases of breast cancer, the cancerous cells have at least one of Estrogen Receptors (ER), Progestin Receptors (PR) and HER2 receptors. The receptor status helps in deciding upon the treatment pathway for the patient. The presence of a receptor is depicted as a positive sign for that receptor and absence is shown as negative. Hormone positive breast cancer can be treated with hormones and HER2+ cancers can be treated with Herceptin, a targeted therapeutic. Triple negative breast cancer (ER-. PR-, HER-) is found in 10-15% of cases and has a very poor prognosis. It has few therapeutic options and does not respond well to either hormonal treatment or Herceptin treatment. molecular profiling in breast cancer http://www.cancer.gov/cancertopics/pdq/treatment/breast/healthprofessional#Section_639
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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

簡報者
簡報註解
Divide the line
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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

簡報者
簡報註解
SOURCE: 2014 http://www.firstwordpharma.com/node/1195713#axzz3arUzic1R 2015 http://www.firstwordpharma.com/node/1287604#axzz3qgEZQFkS
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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

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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

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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