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SPT Investor Presentation 2015

Jan 8, 2015

51922_rns_2015-01-08_6ae42264-a445-465a-ac0d-eb8f1d0693db.pdf

Investor Presentation

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TWSE 1789

ScinoPharm Management Presentation 2015 JP Morgan Healthcare Conference

1

Disclaimer

This material has been prepared by ScinoPharm Taiwan, Ltd. (“ScinoPharm”).

Any opinions expressed in this material are subject to change without notice as a result of using different assumptions. ScinoPharm is under no obligation to update or keep current the information contained herein. The information contained in this presentation is ScinoPharm’s confidential information.

Any disclosure, copying, distribution or any action taken or omitted to be taken in reliance on it is prohibited and may be unlawful.

No representation or warranty , express or implied, is or will be made in or in relation to, and no responsibility or liability is or will be accepted by the Company as to , the accuracy or completeness of this material and any liability therefore is hereby expressly disclaimed.

Statements made in this material include forward-looking statements, which include, without limitation, statements about the issues, plans and expectations of ScinoPharm. Without limiting the foregoing, statements including the words “believes”, “anticipates”, “plans”, “expects” and similar expressions are also forward-looking statements. Forward-looking statements reflect, among other things, management’s plans and objectives for future operations, current views with respect to future events and future economic performances and projections of various financial items. These forward-looking statements involve known and unknown risks , uncertainties and other factors which may cause actual results to differ materially from those implied by such forward-looking statements.

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Confidential

Table of Content

  • Overview of ScinoPharm

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  • ScinoPharm’s Strategies and Opportunities

Operating Results & Outlook

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3

Overview of ScinoPharm - an API + ANDA Company

Active Pharmaceutical Ingredients Abbreviated New D A rug pplication

4

Background

  • Established in 1997 in Taiwan and listed on TWSE in 2011, current market cap around US$1.3 billion

  • Major shareholders include Uni-President Group, National Development Fund, Taiwan Sugar, etc.

  • Facility & organization built in Taiwan by experienced Syntex team, received multiple regulatory inspections from US FDA, Australia, EU, Japan, etc.

  • Specializes in high potency (steroid/cytotoxic) APIs and expands to injectable formulations

  • Expanding in China with a new GMP plant in Changshu & marketing base in Shanghai

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5

World Class API Facilities

Taiwan

  • 6.6 hectares of land, 330K sqft facilities with >200M[3] reactor volume

  • 8 of 18 production lines equipped with high potency capabilities for cytotoxics/steroids

  • US FDA approved & 250+ CGMP audits by customers

  • Provides comprehensive contract research & manufacturing services for brand drug companies

  • Global Market

China

  • 6.6 hectares of land with ~250M[3 ] reactor volume

  • 2 of 8 production lines equipped with high potency capabilities for cytotoxics

  • cGMP designed facility for intermediates & high potency API

  • Full scope capabilities in developing and manufacturing APIs from small to large scale for generic & CRAM markets

  • Global market including China

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Confidential

Innovative Injectable Plant

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Confidential

Business Overview

Risk & return balanced model to offer APIs and fill/finish capability for both generic and new drugs

  • 70 generic APIs developed with 27 APIs launched; 50 US DMFs filed (694 DMFs WW), 24 US DMFs in oncological APIs

80+ NCE CRAM projects, with 5 launched and 7 in phase III for NDA filing in 2-3 years; The Qualified Asian supplier to provide APIs to global market for multiple commercial NCEs

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Confidential
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Sales Distribution

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By Indication
By Business
Others
CMO
15%
CRO 20% Other CNS
3% <1% By Region 22%
Oncology
Rest of AU & NZ ROW 63%
Asia 2% <1%
Generic 11%
India
77%
15%
US &
CAN
EU 53%
Date: up to Q1-Q3 2014 19%
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Confidential

Strong Generics Product Portfolio

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Diversified CRAM Portfolio

Confidential

Confidential
Diversified CRAM Portfolio
Confidential
Diversified CRAM Portfolio
Confidential
Diversified CRAM Portfolio
Confidential
Diversified CRAM Portfolio
Confidential
Diversified CRAM Portfolio
Confidential
Diversified CRAM Portfolio
Stage
First Launch Year
Indication
Location
Commercial
2005
Eluting Stent
US
Commercial
2009/2013
Skin Infection/HAP
US/EU



Stage First Launch Year Indication Location
Commercial 2005 Eluting Stent US
Commercial 2009/2013 Skin Infection/HAP US/EU
Commercial 2011 Depression US
Commercial 2012 Obesity US
Commercial 2013 Seizure US
Stage Est. NDA Filing Year Indication Location
Phase III 2014 Infections US
Phase III 2016 Prostate & Ovarian Cancer EU
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11
Phase III
2016
Prostate Cancer
US
Phase III
2016-2017
Ovarian Cancer
CN
Phase III
2017
Seizure
US
Phase III
2017
Parkinson’s Disease
US
Phase III
2017
Opioid-Induced Constipation
US
11
Phase III 2016 Prostate Cancer US
Phase III 2016-2017 Ovarian Cancer CN
Phase III 2017 Seizure US
Phase III 2017 Parkinson’s Disease US
Phase III 2017 Opioid-Induced Constipation US

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ScinoPharm’s

Strategies and Opportunities

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Confidential

Long Term Strategies

Transforming to a full-scope pharma company per our core competency of R&D and cGMP manufacturing in high-technical barrier APIs

  • :

  • Vertical Integration to Generic Formulations Developing dossiers per our difficult-to-make APIs to increase value proposition in the supply chain

  • :

  • Innovative Delivery Formulations Targeted delivery & extended release of proven APIs via 505(b)2 fast track

  • :

  • Brand New Chemical Entities (New Drugs) Collaborating with academic research institutes, focusing on un-met oncological medical needs of high prevalence in Asia

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Keys to Generic Formulation Business

  • :

  • Expanding formulation portfolio

  • Injectable: 11 drugs planned

  • Oral: 10 drugs planned

  • Ophthalmic: 3 drugs planned

  • To be launched in 2017 through 2024

  • Building on-site oncological injectable facility and establishing a complete supply chain

  • Sustaining B2B model, promoting our formulations via strategic alliance, especially in China and US

  • Acquiring critical resources via M&A

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Confidential

ScinoPharm - Oncological API Leader

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Confidential

Golden Opportunities in China

  • Government’s 12[th] five-year plan encourages pharma industry to grow at a CAGR of 20%

  • Tighten GMP requirements to align with US/EU

  • Motivate drug makers to improve quality by applying for US ANDAs, which need SPT’s world class APIs

  • MNCs and emerging virtual-model players create huge needs in API contract manufacturing in China for compliance

  • ScinoPharm timely captures oncological API needs via importing from Taiwan and local made in Changshu sites

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Strategic Alliances

Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product
launch

t*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product
launch

t*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product
launch

t*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product
launch

t*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product
launch

t*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product
launch

t*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product
launch

t*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product
launch

t*
Partner Product Indications Region Launch
Year(E)
Remarks
Genovate Entecavir Hepatitis B Viral Taiwan 2013* 1st co-developed formulation product
launch
t
Sagent Oncological
Injectable
Myeloid Leukemia US 2017 1s US ANDA filing to trigger US FDA
inspection in Changshu site
Foresee Leuprolide Prostate cancer US 2018 505(b)2 NDA CRAM + Equity
Coland Bortezomib Multiple Myeloma China 2018 1st co-developed drug in China to
trigger CFDA inspection in Changshu
Azacitidine MDS China 2019 Co-developed formulation
Fondaparinux Anti-thrombotic China 2019 1st dru in China
Lee’s Pharma




g
Travoprost
Bimatoprost
Glaucoma
China
2020
Co-developed formulation
Nanjing King
Friend
Regadenoson
Stress agent for heart
scan
China
2020
1st type 3.1 co-developed new drug in
China
Lee’s Pharma g
Travoprost
Bimatoprost
Glaucoma China 2020 Co-developed formulation
Nanjing King
Friend
Regadenoson Stress agent for heart
scan
China 2020 1st type 3.1 co-developed new drug in
China

17 *** Already launched**

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Operating Results & Outlook

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Historical Performance

*** In NT$ million**

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5,085
5,500
4,572
4,500 3,887 3,953
3,791
3,145
3,500
2,494
2,500
1,463
1,010
1,500
572
1,170 1,273
1,040 961
872 1,041
500 613
143
(392) (479)
-500
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
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Recent Financial

*** In NT$ million**

Year
2011
2012
2013
Total assets
9,480
10,339
11,484
hhld’ i**


Year
2011
2012
2013
Total assets
9,480
10,339
11,484
hhld’ i**


Year
2011
2012
2013
Total assets
9,480
10,339
11,484
hhld’ i**


Year
2011
2012
2013
Total assets
9,480
10,339
11,484
hhld’ i**


Year
2011
2012
2013
Total assets
9,480
10,339
11,484
hhld’ i**


Year
2011
2012
2013
Total assets
9,480
10,339
11,484
hhld’ i**


Year 2011 2012 2013
Total assets* 9,480 10,339 11,484
hhld’ i*
Sareoers equty 8,609 9,070 9,643
Sales* 3,953 4,572 5,085
Net profit after tax* 961 1,170 1,273
Earnings per share (NT$) 1.56 1.80 1.88
Cash dividends (NT$/share) 1.0 1.2 1.2
Stock dividends (NT$/share)
0.3
0.4
0.4
Pay-out ratio
83%
89%
85%
Stock dividends (NT$/share) 0.3 0.4 0.4
Pay-out ratio 83% 89% 85%

Note 1: All of the above figures represent consolidated information. Note 2: Data for 2011 and 2012 reported per the standards set by the Financial Accounting Standards Committee (FASC) in Taiwan; data for 2013 reported per international accounting standards.

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2014 Product Launches

2014 Product Launches 2014 Product Launches 2014 Product Launches 2014 Product Launches 2014 Product Launches 2014 Product Launches 2014 Product Launches 2014 Product Launches
API
Region
Indications
Brand Marketer
Regional Sales
WW Sales
Azacitidine
US
MDS
Oncology
Celgene
US$358MM
US$818MM
Dantrolene
Malinant
JHP**

API Region Indications Brand Marketer Regional Sales WW Sales
Azacitidine US MDS
Oncology
Celgene US$358MM* US$818MM*
Dantrolene Malinant JHP
(injectable) US g
hyperthermia

Pharmaceuticals
US$20MM* US$46MM*
Decitabine US MDS, AML
Oncology
Eisai US$250MM* US$289MM*
Docetaxel
trihydrate
JP Oncology Sanofi Aventis US$180MM
(Taxotere)**
US$1,422MM*
Entecavir TW Hepatitis B virus BMS US$67MM*** US$1,413MM*
Exemestane US Breast cancer Pfizer US$995MM* US$3001MM*


.
.
Riluzole
(liquid)
EU
Amyotrophic lateral
sclerosis
Sanofi Aventis
US$66MM
US$187MM
Zoledronic acid
JP
Osteoporosis
Novartis
US$120MM*
US$1,361MM***
. .
Riluzole
(liquid)
EU Amyotrophic lateral
sclerosis
Sanofi Aventis US$66MM* US$187MM*
Zoledronic acid JP Osteoporosis Novartis US$120MM*** US$1,361MM*

Source: * IMS Data (Year 2013) ** Datamonitor In-house research*

Launched

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Pipeline Outlook

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� 4-5 new launches � 8-10 new launches � 6-8 new launches
� US FDA inspection on SPC � 1 [st] co-developed drug � 1 [st] type 3.1 co-developed
product launched in China new drug launched in
� US FDA inspection on INJ China
2015 2016 2017 2018 2019 2020
� 5-6 new launches � 5-6 new launches � 7-9 new launches
� 1 [st] ANDA product � 1 [st ] drug product
launched in US launched in China
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Confidential

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Brand Quality with Asian Advantages

www.scinopharm.com

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