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SPT Investor Presentation 2016

May 10, 2016

51922_rns_2016-05-10_25283cd2-f86c-4113-9bf5-f35a3c5109b0.pdf

Investor Presentation

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TWSE 1789

ScinoPharm Management Presentation

2016/05/11

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. Forwardlooking 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

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  • Overview of ScinoPharm

  • ScinoPharm’s Strategies and Opportunities

  • Operating Results & Outlook

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3

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Overview of ScinoPharm

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4

Background

  • Established in 1997 in Taiwan and listed on TWSE in 2011

  • 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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5

World Class API Facilities

Taiwan

China

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

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

  • 6 of 16 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

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  • 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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6

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; 56 US DMFs filed (738 DMFs WW), 29 US DMFs in oncology APIs

  • 100+ NCE CRAM projects, with 5 launched and 5 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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7

Confidential

2015 Sales Distribution

By Indication

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By Business
By Region
Generic
77%
8
8
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Confidential

Strong Generics Product Portfolio

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45 42
40
28
35
30
25
20
unlaunched
15
3 launched
9
10 7
1414 3 4 5
3 3
5 6 2 2 2 2 2
14 3
6 2 3
1 [2] 1 1 2 1 3 2 2 2
0 2
1 2 3 2 2
2
2 2 2 2
1 1
2
9
11
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Confidential

Diversified CRAM Portfolio

Stage
First Launch Year
Indication
Location



Stage
First Launch Year
Indication
Location



Stage
First Launch Year
Indication
Location



Stage
First Launch Year
Indication
Location



Stage
First Launch Year
Indication
Location



Stage
First Launch Year
Indication
Location



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
Phase III 2017 Prostate Cancer US
Phase III
2017
Ovarian Cancer
CN
Phase III
2017
Parkinson’s Disease
US
Phase III 2017 Ovarian Cancer CN
Phase III 2017 Parkinson’s Disease US

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ScinoPharm’s Strategies and Opportunities

11

Confidential

Long Term Strategies

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

12

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

13

Strategic Alliance Highlights

*** Already launched**

Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product launch*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product launch*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product launch*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product launch*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product launch*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product launch*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product launch*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Viral
Taiwan
2013
1st co-developed formulation product launch*
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 2020 Co-developed formulation
Lee’s
Pharma
Fondaparinux Anti-thrombotic China 2020 1st self-developed drug in China
Travoprost
Bimatoprost
Glaucoma China 2022 Co-developed formulations
Nanjing
King
Friend
Regadenoson Stress agent for
heart scan
China 2020 1st type 3.1 co-developed new drug in China
US
partner
Project A
non-small cell
lung cancer
US
2019
US NDA 505(b)2 & Paragraph IV filing
US &
China
partners
Project B
imaging agent
US
2019
Paragraph IV filing
US
partner
Project A non-small cell
lung cancer
US 2019 US NDA 505(b)2 & Paragraph IV filing
US &
China
partners
Project B imaging agent US 2019 Paragraph IV filing

14

Confidential

ScinoPharm - Oncology API Leader

Stand-Alone API Company

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ScinoPharm 29 26
Shilpa 12 9 2
Polymed 10 1 3
# Oncology DMF Overlap with SPT
MacChem Products 7 5 2
# 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
Source: US FDA 2016 Q1
15
DMF database 0 50 100 150 200 250 300
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Operating Results & Outlook

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Historical Performance

Unit: In NT$ million

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5,088
4,572
5,000
4,098
3,887 3,953 3,955
3,791
4,000
3,145
2,494
3,000
2,000 1,463
613 1,273 484
1,000 872 1,170
1,041 1,040
143 961
635
484
0
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
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Recent Financial

*** In NT$**

Year
2013
2014
2015
Year
2013
2014
2015
Year
2013
2014
2015
Year
2013
2014
2015
Year
2013
2014
2015
Year
2013
2014
2015
Year 2013 2014 2015
Total assets* 11,484 M 11,372 M 12,222 M
Shareholders’ equity* 9,643 M 9,380 M 9,857 M
Sales* 5,088 M 4,098 M 3,955 M
Net profit after tax* 1,273 M 484 M 635 M
Earnings per share 1.88 0.69 0.87
Cash dividends
(NT$/share)
1.2 0.2 0.3
Stock dividends
(NT$/share)
0.4 0.4 0.4
Pay-out ratio 85% 87% 80%

Note : All of the above figures represent consolidated information

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18

Quarterly P&L - Consolidated

In NT$ million, except for EPS
1Q 2016
(Reviewed)
1Q 2015
(Reviewed)
YoY
In NT$ million, except for EPS
1Q 2016
(Reviewed)
1Q 2015
(Reviewed)
YoY
In NT$ million, except for EPS
1Q 2016
(Reviewed)
1Q 2015
(Reviewed)
YoY
In NT$ million, except for EPS
1Q 2016
(Reviewed)
1Q 2015
(Reviewed)
YoY
In NT$ million, except for EPS
1Q 2016
(Reviewed)
1Q 2015
(Reviewed)
YoY
In NT$ million, except for EPS
1Q 2016
(Reviewed)
1Q 2015
(Reviewed)
YoY
In NT$ million, except for EPS 1Q 2016
(Reviewed)
1Q 2015
(Reviewed)
YoY
Net Sales 1,022 979 4%
Gross Profit 431 344 25%
Gross margin 42% 35%
Operating Expenses (236) (203) 16%
Operating Income 195 141 39%
Operating margin 19% 15%
Other Rev.(Exp.) (4) (7) -35%
Net Income before Tax 191 134 42%
Nt Inm ftr T 172 113 52%
e coe ae ax



Net margin after tax
17%
12%
EPS (after tax)
0.24
0.15
60%
e coe ae ax
Net margin after tax 17% 12%
EPS (after tax) 0.24 0.15 60%

19

Balance Sheet- Consolidated

In NT$ million
2016/3/31
(Reviewed)
2015/3/31
(Reviewed)
In NT$ million
2016/3/31
(Reviewed)
2015/3/31
(Reviewed)
In NT$ million
2016/3/31
(Reviewed)
2015/3/31
(Reviewed)
In NT$ million
2016/3/31
(Reviewed)
2015/3/31
(Reviewed)
In NT$ million
2016/3/31
(Reviewed)
2015/3/31
(Reviewed)
In NT$ million
2016/3/31
(Reviewed)
2015/3/31
(Reviewed)
In NT$ million
2016/3/31
(Reviewed)
2015/3/31
(Reviewed)
In NT$ million 2016/3/31
(Reviewed)
2015/3/31
(Reviewed)
Cash and Cash Equivalents 2,560 21% 2,008 17%
Accounts Receivable 645 5% 653 6%
Inventories 2,167 17% 2,402 21%
Long-Term Investments 364 3% 244 2%
Property, plant & equipment 5,361 43% 5,109 44%
Other assets 1,394 11% 1,155 10%
Total Assets 12,491 100% 11,571 100%
20
Current Liabilities
2,374
19%
2,004
17%
L-T Liabilities and Others
90
1%
91
1%
Stockholders’ Equities
10,027
80%
9,476
82%
Current Liabilities 2,374 19% 2,004 17%
L-T Liabilities and Others 90 1% 91 1%
Stockholders’ Equities 10,027 80% 9,476 82%

Cash Flows- Consolidated

In NT$ million
1Q 2016
(Reviewed)
1Q 2015
(Reviewed)
In NT$ million
1Q 2016
(Reviewed)
1Q 2015
(Reviewed)
In NT$ million
1Q 2016
(Reviewed)
1Q 2015
(Reviewed)
In NT$ million
1Q 2016
(Reviewed)
1Q 2015
(Reviewed)
In NT$ million
1Q 2016
(Reviewed)
1Q 2015
(Reviewed)
In NT$ million 1Q 2016
(Reviewed)
1Q 2015
(Reviewed)
Cash and cash equivalents at
beginning of period
2,336 1,928
Cash flows from operating activities 663 241
CAPEX (263) (269)
Short-term borrowings (16) 86
Others (160) 22
14
21
Cash and cash equivalents at
end of period
2,560
2,008
Cash and cash equivalents at
end of period
2,560 2,008

2016 Product Launch Plan

API
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
API
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
API
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
API
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
API
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
API
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
API
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
API
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
API Region Indication Brand
Marketer
Regional
Sales
WW Sales
Azacitidine USA Myelodysplastic
syndromes (MDS)
Celgene US$248.1M US$751.6M
Desmopressin
Acetate
USA Polyuria Ferring US$150.1M US$395.8M
Entecavir USA
Singapore
Hepatitis B
Virus (HBV)
Bristol-Myers US$262.5M
(USA only)
US$1,576.6M
Australia
Flumazenil Korea Reversal of the
sedative effects of
benzodiazepines
Roche N/A US$84.0M
Gemcitabine
HCl
Middle
East
Pancreas, Lung,
Ovary, Breast
Cancers
Eli Lilly N/A US$547.9M
.
Tamsulosin
HCl
USA
Benign Prostatic
Hyperplasia (BPH)
Boehringer
Ingelheim
US$410.0M
US$1,818.4M
Source: : IMS Data (2014Q4-2015Q3)
Launched
.
Tamsulosin
HCl
USA Benign Prostatic
Hyperplasia (BPH)
Boehringer
Ingelheim
US$410.0M US$1,818.4M

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Pipeline Outlook

  • 4-6 new launches5-6 new launches

  • 5-6 new launches

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� 1 [st] co-developed US � 1 [st ] home-made drug US � 1 [st ] home-made drug launched in US
ANDA launched ANDA filing � 3 drug products launched in China
2016 2017 2018 2019 2020
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  • 3-5 new launches6-8 new launches

  • 1[st] self-developed US ANDA launched

  • 1 drug product launched in China

  • Chinese CFDA inspection at SPC

  • 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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