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SPT Investor Presentation 2016

Jan 13, 2016

51922_rns_2016-01-13_ab13e168-0830-4178-bdd0-557b91f60f47.pdf

Investor Presentation

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TWSE 1789

ScinoPharm Management Presentation 2016 JP Morgan Healthcare Conference

Yung Fa Chen, Ph.D. President & CEO

Patricia Chou CFO & VP Corporate Development

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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

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Overview of ScinoPharm

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Background

  • Established in 1997 in Taiwan and listed on TWSE in 2011, current market cap around US$1.2 billion

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

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

  • Specializes in high potent/cytotoxic APIs & moves to injectable formulations

  • Expanding in China with a marketing base in Shanghai & new GMP plant in Changshu, just inspected by US FDA with zero 483

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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 cytotoxic/steroids

  • Passed US FDA, EMA, Australian TGA, Japanese PMDA inspections & 300+ cGMP customer audits

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

  • Global Market

China

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

  • 3 of 7 production lines equipped with high potency capabilities for cytotoxics

  • US FDA approved cGMP facility for intermediates & high potency API

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

  • Global market including China

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Confidential

Business Overview

Risk & return balanced model to offer APIs and sterile filling capability for both generic and new drugs

  • 80+ generic APIs developed with 27 APIs launched; 55 US DMFs filed (733 DMFs WW), 29 US DMFs in oncology APIs

100+ NCE CRAM projects, with 5 launched and 6 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
By Indication
2015 Sales Distribution
CNS Others
17% 7%
By Business
CMO BD Oncology
CRO 8% 2% By Region 76%
5%
Rest of Oncology
ROW
Asia AU&NZ 63%
<1%
Generics
12% 5%
85%
Generic
77% India
US&CAN
18%
42%
EU
23%
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8
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Strong Generics Product Portfolio

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Confidential
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45 42
40
28
35
30
25
20
unlaunched
3
15
9 launched
14
7
10
3 4 5
3 3
5 6 2 2 2 2 2
6 2 2 3
1 1 1 2 1 3 2 2 2
0
2
9
9 11
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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 2016 Infections US / EU / Asia
Phase III 2017 Ovarian Cancer US / EU
11
10
Phase III
2017
Prostate Cancer
US
Phase III
2017
Ovarian Cancer
CN
Phase III
2017
Seizure
US
Phase III
2017
Parkinson’s Disease
US
10
Phase III 2017 Prostate Cancer US
Phase III 2017 Ovarian Cancer CN
Phase III 2017 Seizure US
Phase III 2017 Parkinson’s Disease 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 start-ups & research institutes, focusing on un-met oncology medical needs of high prevalence in Asia

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Keys to Generic Formulation Business

  • Expanding formulation portfolio

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

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

  • Acquiring critical resources via M&A

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Strategic Alliance Highlights

Strategic Alliance Highlights Strategic Alliance Highlights Strategic Alliance Highlights Strategic Alliance Highlights Strategic Alliance Highlights Strategic Alliance Highlights Strategic Alliance Highlights Strategic Alliance Highlights
Partner
Product
Indications
Region
Launch Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product launch
Sagent
Oncology
Injectable
Myeloid Leukemia
US
2016
1st US ANDA filing, triggered US FDA inspection in
Changshu site*
Partner
Product

Indications

Region

Launch Year(E)
Remarks
Genovate Entecavir Hepatitis B Viral Taiwan 2013* 1st co-developed formulation product launch
Sagent Oncology
Injectable
Myeloid Leukemia US 2016 1st US ANDA filing, triggered US FDA inspection in
Changshu site
Foresee Leuprolide Prostate cancer US 2018 505(b)2 NDA CRAM + Equity
Coland Bortezomib Multiple Myeloma China 2019 1st co-developed drug in China to trigger CFDA
inspection in Changshu site
Azacitidine MDS China 2021 Co-developed formulation
Lee’s
Pharma
Fondaparinux Anti-thrombotic China 2022 1st self-developed drug in China
Travoprost
Bimatoprost
Glaucoma China 2022 Co-developed formulations
Nanjing
Regadenoson Stress agent for heart scan China 2021 1st type 3.1 co-developed new drug in China
King Friend




US partner
Project A
non-small cell lung cancer
US
2018
US NDA 505(b)2 & Paragraph IV filing
US & China
partners
Project B
imaging agent
US
2018
Paragraph IV filing
King Friend
US partner Project A non-small cell lung cancer US 2018 US NDA 505(b)2 & Paragraph IV filing
US & China
partners
Project B imaging agent US 2018 Paragraph IV filing

*** Already launched**

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ScinoPharm - Oncology API Leader

Confidential

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Stand-Alone API Company
ScinoPharm 29 26
Shilpa 12 9 2
Polymed 10 1 3
MacChem Products 7 5 2 # Oncology DMF Overlap with SPT
# Non-overlapping Oncology DMF
Laurus Labs 7 6 10 # Other DMFs
Sichuan Xieli 6 8 13
Chemwerth 3 5 30
Apicore 5 5 22
0 10 20 30 40 50 60
Big Generic Pharmaceutical Company
ScinoPharm 29 26
Teva 16 23 253
Dr. Reddy's 17 12 192
Cipla 10 16 124
Sun 16 11 167
Hisun 11 21 48 # Oncology DMF Overlap with SPT
# Non-overlapping Oncology DMF
Qilu 7 2 8
# Other DMFs
Hengrui 33 9
15
0 50 100 150 200 250 300
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Confidential
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ScinoPharm Pipeline Echoes Therapy Trend

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Ophthalmology 3%
Genetic disorder 3% Others 3% Chemotherapy Supportive
care
9%
Respiratory 3%
5%
Gastrointestinal 6%
Hormonal
therapy
Infectious 9%
disease Oncology
6% 34%
Targeted
Metabolic therapy
disorder
77%
10% CNS
CV
12%
10%
Immunology
10%
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Confidential

Forces Reshaping Chinese Pharma Market

  • Policy reform expediting drug approvals, allowing new drug developers to own drug licenses without manufacturing sites

  • Significantly lifting the cost structure & entry barrier in Chinese drug market, with a heavy focus on quality and innovation

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

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

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Advantages in Growing Chinese Market

  • Direct benefit from the new GMP standards and policy reform

  • Tailor-made product portfolio for Chinese market

  • Domestic presence plus world-class strengths in:

*** High-technical-barrier oncology APIs**

  • Global first tier customer base

  • Quality and EHS/GMP compliance

  • Bridge between Chinese and global markets

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Portfolio for Chinese Aging Society

14 drug licenses applied and 6 collaborated with local marketers for popular age-related diseases in China

Benazepril as the first granted import drug license

Oncology Cardiovascular Urology Glaucoma Alzheimer Others Anastrozole Benazepril *Tamsulosin Bimatoprost Galantamine Celecoxib Capecitabine Bivalirudin Travoprost Entecavir Docetaxel Fondaparinux Dantrolene Gemcitabine Regadenoson Irinotecan Paclitaxel Azacitidine Bortezomib

  • Submit drug import license applications or production permits

**Co-developed product targeted for Chinese market

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Operating Results & Outlook

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Historical Performance

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Unit: In NT$ million * For Q1-Q3 only
5,088
5,000 4,572
4,098
3,887 3,953 3,955
3,791
4,000
3,145
3,000 2,494
2,000 1,463
613 1,273 484
1,000 872 1,041 1,040 1,170
143
961
484 440
0
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
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Recent Financial

*** In NT$ million**

Year
2013
2014
Q1-Q3 or 9/30
2015
Total assets*
11,484M
11,372M
11,995M
Year
2013
2014
Q1-Q3 or 9/30
2015
Total assets*
11,484M
11,372M
11,995M
Year
2013
2014
Q1-Q3 or 9/30
2015
Total assets*
11,484M
11,372M
11,995M
Year
2013
2014
Q1-Q3 or 9/30
2015
Total assets*
11,484M
11,372M
11,995M
Year
2013
2014
Q1-Q3 or 9/30
2015
Total assets*
11,484M
11,372M
11,995M
Year
2013
2014
Q1-Q3 or 9/30
2015
Total assets*
11,484M
11,372M
11,995M
Year 2013 2014 Q1-Q3 or 9/30
2015
Total assets* 11,484M 11,372M 11,995M
Shareholders’ equity* 9,643M 9,380M 9,701M
Sales* 5,088M 4,098M 2,925M
Net profit after tax* 1,273M 484M 440M
Earnings per share (NT$) 1.88 0.69 0.60
Cash dividends (NT$/share)
1.2
0.2
-
Stock dividends (NT$/share)
0.4
0.4
-
Pay-out ratio
85%
87%
-
Cash dividends (NT$/share) 1.2 0.2 -
Stock dividends (NT$/share) 0.4 0.4 -
Pay-out ratio 85% 87% -

Note : All of the above figures represent consolidated information

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2016 API Product Launches

2016 API Product Launches 2016 API Product Launches 2016 API Product Launches 2016 API Product Launches 2016 API Product Launches 2016 API Product Launches 2016 API Product Launches 2016 API Product Launches
Product Name
Region
Indications
Brand Marketer
Regional Sales
WW Sales
Azacitidine
USA
Myelodysplastic
syndromes (MDS)
Celgene
US$257.2M
US$771.9M**
Product Name Region Indications Brand Marketer Regional Sales* WW Sales*
Azacitidine USA Myelodysplastic
syndromes (MDS)
Celgene US$257.2M US$771.9M
Desmopressin
Acetate
USA Polyuria Ferring US$140.1M US$393.3M
Entecavir USA,
Singapore,
Australia
Hepatitis B
Virus (HBV)
Bristol-Myers US$286M
(USA only)
US$1591.6M
Flumazenil Korea Reversal of the
sedative effects of
benzodiazepines
Roche N/A US$86.2M
Pancreas, Lung,
Gemcitabine HCl
Middle East

Ovary, Breast
Cancers.
Eli Lilly
N/A
US$583.4M
Tamsulosin
USA
Benign Prostatic
Hyperplasia (BPH)
Boehringer Ingelheim
US$411.1M
US$1853.2M
Gemcitabine HCl Middle East
Ovary, Breast
Cancers.
Eli Lilly N/A US$583.4M
Tamsulosin USA Benign Prostatic
Hyperplasia (BPH)
Boehringer Ingelheim US$411.1M US$1853.2M

Source *IMS Data (2014Q3-2015Q2)

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Pipeline Outlook

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� 4-6 new launches � 5-6 new launches � 5-6 new launches
� 1 [st] co-developed US � 1 [st ] home-made drug US � 3 drug products launched in China
ANDA launched � 1 [st ] home-made drug launched in US
ANDA filing
2016 2017 2018 2019 2020
� 3-5 new launches � 6-8 new launches
� 1 [st] self-developed US � SPC China FDA inspection
� 3 drug products launched in China
ANDA launched
� US FDA inspection at INJ
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Confidential

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Brand Quality with Asian Advantages

www.scinopharm.com

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