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SPT Investor Presentation 2016

Mar 8, 2016

51922_rns_2016-03-09_f3f292e6-6eca-41d1-8cf5-886797d36d25.pdf

Investor Presentation

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TWSE 1789

ScinoPharm Management Presentation

Fourth Quarter 2015 Investor Conference

February 18, 2016

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.

2

Table of Content

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  • Overview of ScinoPharm

  • Financial & Operating Results in 4Q 2015

  • Perspectives in Latin American Market

3

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Overview of ScinoPharm

- An API + ANDA Company

Active Pharmaceutical Ingredients Abbreviated New D A rug pplication

44

Confidential

Business Overview

  • Established in 1997 in Taiwan, listed on TWSE in 2011, and honored as the top 5% TWSE issuer in info disclosure & corporate governance

  • Specialized in high potency (cytotoxic/steroid) APIs and integrating to injectable formulations

  • Facility built in Taiwan and expanding in China with a marketing base in Shanghai and a newly US FDA approved plant in Changshu

  • 80 generic APIs developed with 27 APIs launched; 55 US DMFs filed (734 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

  • Fully Complied with world-class cGMP and regulatory requirements; Certified by US FDA, EMA, Australian TGA, Japanese PMDA, Korean FDA, Mexican COFEPRIS, etc.

5

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 oncology medical needs of high prevalence in Asia

6

Keys to Generic Formulation Business

  • Expanding formulation portfolio

  • Building on-site injectable facility and forming a complete supply chain of drug products

  • Promoting our formulations via strategic alliance, especially in China, US, & EU

  • Acquiring critical resources via M&A

7

Strong Generics Product Portfolio

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45 42
40
28
35
30
25
20
unlaunched
3
15 9
launched
7
14
10 5
3 4
5 14 6 3 3 2 2 2 2 2
3
6 2 2
1 [2] 1 1 2 2 31 3 2 2 2
0
2 2 2 2
1 1
2
8 11
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ScinoPharm - Oncology API Leader

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Stand-Alone API Company
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 3 3 9
0 50 100 150 200 250 300
Source: US FDA (2015Q3) 9
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Strate ic Alliance Hi hli hts g g g

*** Launched already**

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 Oncological
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 Strategic alliance collaboration in
formulation
Travoprost
Bimatoprost
Glaucoma China 2022 Strategic alliance collaboration in
formulations
Nanjing
King
Friend
Regadenoson Stress agent for
heart scan
China 2020 1st type 3.1 co-developed new drug in
China
10
Already launched*
US partner
Project A
non-small cell
lung cancer
US
2019
US NDA 505(b)2 & Paragraph IV filing
US &
Chinese
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
10
Already lau*
US &
Chinese
partners**
nched
Project B
imaging agent US 2019 Paragraph IV filing

10

2016 API Product Launch Plan

Product Name
Region
Indications
Brand Marketer
Regional Sales
WW Sales
Product Name
Region
Indications
Brand Marketer
Regional Sales
WW Sales
Product Name
Region
Indications
Brand Marketer
Regional Sales
WW Sales
Product Name
Region
Indications
Brand Marketer
Regional Sales
WW Sales
Product Name
Region
Indications
Brand Marketer
Regional Sales
WW Sales
Product Name
Region
Indications
Brand Marketer
Regional Sales
WW Sales
Product Name
Region
Indications
Brand Marketer
Regional Sales
WW Sales
Product Name
Region
Indications
Brand Marketer
Regional Sales
WW Sales
Product Name Region Indications 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
Tamsulosin
HCl
USA Benign Prostatic
Hyperplasia (BPH)
Boehringer
Ingelheim
US$410.0M US$1,818.4M

Source: *IMS Data (2014Q4-2015Q3)

11

Pipeline Outlook

  • 5-6 new launches

  • 4-6 new launches5-6 new launches

    • 1[[st ]] home-made drug launched in US
  • 1[st] co-developed US1[st ] home-made drug US 1[[st ]] home-made drug launched in US ANDA launched ANDA filing3 drug products launched in China

  • 2016 2017 2018 2019 2020

  • 3-5 new launches6-8 new launches

  • 1[st] self-developed US ANDA launched

  • Chinese CFDA inspection at SPC

  • 1 drug product launched in China

  • US FDA inspection at INJ

12

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Financial & Operating Results

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13 10

Profit & Loss - Consolidated

In NT$ million, except for EPS
FY 2015
(Unaudited)
FY 2014
(Audited)
YoY
In NT$ million, except for EPS
FY 2015
(Unaudited)
FY 2014
(Audited)
YoY
In NT$ million, except for EPS
FY 2015
(Unaudited)
FY 2014
(Audited)
YoY
In NT$ million, except for EPS
FY 2015
(Unaudited)
FY 2014
(Audited)
YoY
In NT$ million, except for EPS
FY 2015
(Unaudited)
FY 2014
(Audited)
YoY
In NT$ million, except for EPS
FY 2015
(Unaudited)
FY 2014
(Audited)
YoY
In NT$ million, except for EPS FY 2015
(Unaudited)
FY 2014
(Audited)
YoY
Operating Revenue 3,955 4,098 -3%
Gross Profit 1,677 1,600 5%
Gross margin 42% 39%
Operating Expenses (927) (1,041) -11%
Operating Income 750 559 34%
Operating margin 19% 14%
Other Rev. (Exp.) 53 43 23%
Net Income before Tax 803 602 33%
Net Income after Tax
635
484
31%
Net margin after tax
16%
12%
EPS (after tax)
0.87
0.66
32%
Net Income after Tax 635 484 31%
Net margin after tax 16% 12%
EPS (after tax) 0.87 0.66 32%

14

Balance Sheet- Consolidated

In NT$ million 2015/12/31
(Unaudited)
2015/12/31
(Unaudited)
2014/12/31
(Audited)
2014/12/31
(Audited)
Cash and Cash Equivalents 2,336 19% 1,928 17%
Accounts Receivable 867 7% 523 5%
Inventories 2,169 18% 2,449 22%
Long-Term Investments 339 3% 248 2%
Property, Plant & Equipment 5,171 42% 5,065 44%
Other Current/Non-Current Assets 1,340 11% 1,159 10%
Total Assets 12,222 100% 11,372 100%
Current Liabilities
2,275
18%
1,918
17%
Long-Term & Other Liabilities
90
1%
74
1%
Stockholders’ Equities
9,857
81%
9,380
82%
15
Current Liabilities 2,275 18% 1,918 17%
Long-Term & Other Liabilities 90 1% 74 1%
Stockholders’ Equities 9,857 81% 9,380 82%

Cash Flows- Consolidated

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FY 2015 FY 2014
In NT$ million
(Unaudited) (Audited)
Cash and cash equivalents at
1,928 2,289
be innin of eriod
g g p
Cash flows from operating activities 1,045 888
CAPEX (657) (1,018)
Short-term borrowings 425 588
Cash Dividends (141) (811)
Others (264) (8)
Cash and cash equivalents at
2,336 1,928
end of eriod
p
16
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Sales by Business

FY2015

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BD
CRO
CMO
2%
5%
8%
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----- Start of picture text -----

FY2014
CRO+BD
CMO
4%
Generics
20%
85%
Generics
76%
17
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Sales by Indications

FY2015

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CNS Others
17% 7%
FY2014
Oncology
Others
76%
11%
CNS Oncology
27% Oncology60%
62%
18
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Sales by Region

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Sales by Region FY2015
Rest of
ROW
AU/NZ
Asia
<1%
5%
12%
FY2014 India
US/CAN
18%
Rest of AU/NZ 42%
ROW EU
Asia 2%
<1%
23%
11%
India
15%
US/CAN
EU 42%
30%
19
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Perspectives in Latin American Market

20

Pharmerging Markets

  • IMS Health identified 21 countries as the “Pharmerging” markets per their macroeconomics and pharma market forecasts

  • Tier 1: China -- accounts for half of Pharmerging market growth; Tier 2: Brazil, India, & Russia; Tier 3: Argentina, Colombia, Mexico, Poland, Turkey, Venezuela

  • Governments in Pharmerging markets promote generics to expand healthcare coverage cost effectively

  • Branded generics are popular in Pharmerging markets as quality assurance

  • Big Pharmas tap M&A for local expansion and market presence

21

Opportunities in Latin America

  • The main consumers aged 20-50 account for 44% of 600Mn people. Latin America as a key growth region of 14% CAGR in 2008 thru 2012 and expected to keep outgrowing after 2016

  • Governments encourage generic drugs, manage drug pricing affordable in the domestic market, and elevate generic drug penetration rate to 30% – 50%

  • A high level of imported drugs pushes local governments to support domestic firms via favorable policies

  • Argentina, Brazil, and Colombia upgrading into regulated markets and cultivating regional trading via continual GMP regulatory tightening and harmonization

22

Latin American Markets Fuel the Growth

Share of pharmaceutical spending by region 2013-2017

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38% 35%
Source: Americas Market Intelligence
23
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Product Mix Fits Key Needs in Americas

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Source: WHO; PWC strategy & analysis
24
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Market Size

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Colombia
US$2.9Bn
Venezuela
US$10.2Bn
Mexico
US$12.4Bn
Brazil
US$31.4Bn
Chile
Others Argentina
US$2.1Bn
US$8Bn
US$6.6Bn
Source: Sales in 2012, Americas Market Intelligence
25
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Major Latin American Landscape

  • Brazil keeps lifting its healthcare expenditure, accounting for Latin American pharma sales of 45% and expected to become the global 5[th] largest pharm market soon

  • Mexico, as the region’s 2[nd] largest market, bridges the well-established and emerging markets in Americas. Mexico’s expansion in healthcare coverage triggers the demand for generic drugs, with 70% penetration

  • Argentina actively promotes its pharmaceutical industry, which exports finished and semi-finished drugs to over 115 countries, mainly to the US, EU and Brazil

26

Growing Customer Base in Latin America

  • ScinoPharm reaching out new business along with big pharma customers’ M&As, cultivating over 10 domestic customers by 2015

  • Sales in Latin America has grown 90% in 2015 from 2014 and is expecting a significant growth continuously

  • Both Tainan and Changshu sites passed GMP inspection by Mexican regulatory agency COFEPRIS

  • Aim to be a vital API supplier to the high-end oncology generic and brand name drugs in Latin America

27

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uestions Q

&

Answers

28

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Brand Quality with Asian Advantages www.scinopharm.com

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