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SPT Investor Presentation 2016

May 10, 2016

51922_rns_2016-05-10_1ad61c40-2943-4b7d-852a-73a09bd02375.pdf

Investor Presentation

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TWSE 1789

ScinoPharm Management Presentation

First Quarter 2016 On-Line Investor Meeting

May 10, 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.

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Table of Content

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  • Overview of ScinoPharm

  • ScinoPharm Changshu Operating Update

  • Financial & Operating Results in Q1, 2016

  • Japan Market Observation

  • Product Launch Update

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Overview of ScinoPharm

- An API + ANDA Company Active Pharmaceutical Ingredients Abbreviated New D rug Application

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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; 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 1-3 years

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

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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

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

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

  • Acquiring critical resources via M&A

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ScinoPharm Changshu Operating Update

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Short-Term Goal

To provide API contract development and manufacturing services for both multinational and China domestic pharmas

  • Major base for large volume API with regulatory supports

  • To be able to produce high value added intermediates for SPT

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The Completive Advantages

  • Process Development Capability

Collaborating with a partner specialized in enzymatic technology to integrate with ScinoPharm in-house strong chemical synthesis capabilities for providing services to develop greener, safer, and more cost-effective API manufacturing processes

  • GMP Production Capability

Knowledge to design, develop, and test parameters of spray drying process for APIs which are difficult-to-dry, are sensitive to long drying residence time, or require uniform particle size distribution

  • Regulatory Compliance Capability

Fully compliant with the most advanced guideline published by EMA in 2014 to set the standards for production line segregation and equipment cleaning criteria

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Operating Progress

  • Actively implementing more than 20 contract research or manufacturing projects every year

  • 9 US/EU customers and 3 of them are top 10 big pharmas

  • Strategically partnership with Lee’s Pharma in China to provide API process development and manufacturing services for more than 15 projects

  • Successfully passed 14 GMP and 2 EHS audits conducted by customers

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Selected List of CRAM Projects at SPC

No Customer Project Type Product Indication/stage Product
Type
Remarks/
Market
Passed Mexican
**1 ** Top 10 global pharma CMO Approved antidepressant drug in US GMP
Intermediate

authority (APIF)
GMP inspection
**2 ** Top 5 global pharma CMO Approved African sleeping disease
drug
API Site transfer
from SPT
**3 ** Lee’s Pharma CRO+CMO +15 items including topical anesthetic,
brain tumor, antibiotic, hypertension,
eye drop, etc.
API China
**4 ** China pharm company CRO Phase II/ III clinical trial for cancer API China
**5 ** China pharm company **CRO+CMO ** Phase IIb for age-related macular
degeneration
API US/China
**6 ** Taigen Biotech CRO Phase II clinical trial for myocardial
infarction
API China/Taiwan
**7 ** US-based new drug company CRO Phase II clinical trial for prevention of
HIV infection
API US
**8 ** Alsan Pharmaceuticals **CRO+CMO ** Phase II clinical trial for cancer API China/Global
**9 ** Top 5 global pharma CMO Phase II clinical trial for diabetes
Intermediate US
10 Top 5 global pharma **CRO+CMO ** Phase I clinical trial API NA
11 US NASDAQ listed pharma CRO Phase III clinical trial for opioid-
induced constipation
Crude API US

Key Progress for China Market

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ScinoPharm
Taiwan
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Submitted drug import license applications for 12 APIs (anti-cancer, cardiovascular, Alzheimer's disease, benign prostatic hyperplasia, hepatitis B, etc. )

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ScinoPharm
Changshu
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  • Obtained drug production permits for 11 APIs for anti-cancer, anti-viral, glaucoma, etc. )

  • Submitted 5 drug license applications for USFDA, 1 for EDQM and 2 for CFDA

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Strategic
Alliance
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5 formulation development and 1 new drug projects smoothly undergoing. Expected to be commercially available in 2019-2022

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Financial & Operating Results

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Quarterly P&L - Consolidated

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1Q 2016 1Q 2015
In NT$ million, except for EPS YoY
(Reviewed) (Reviewed)
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%
Net Income after Tax 172 113 52%
Net margin after tax 17% 12%
EPS (after tax) 0.24 0.15 60%
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Balance Sheet- Consolidated

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2016/3/31 2015/3/31
In NT$ million
(Reviewed) (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%
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%
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Cash Flows- Consolidated

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

2016 Q1

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CMO BD
CRO
1% 1%
6%
2015 Q1
CMO BD
CRO
2% 2%
9%
Generics
92%
Generics
87%
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Sales by Indications

2016 Q1

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Others
14%
CNS
2015 Q1
11%
Oncology
75%
Oncology
60%
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Sales by Region

2016 Q1

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JP AU+NZ ROW
8% 4% 6%
2015 Q1 India
3%
EU
JP AU+NZ ROW
US+CAN
25%
4% 4% 8%
54%
India
22% US+CAN
40%
EU
22%
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Top 5% of Corporate Governance Evaluation

  • Ranked in the top 5% among all TWSE listed companies from the 2st Corporate Governance Evaluation, also the , only healthcare company to be included

  • Being the only healthcare to receive the honor for 2 consecutive years

  • A clear indication of ScinoPharm's efforts and

achievements in protecting shareholder interests, equal treatment of shareholders, Board of Directors organization and operations, information transparency, and corporate social responsibility

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Japan Market Observation

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Japanese Generics Landscape

  • The government strongly supports for generic drugs, aiming to 80% volume penetration rate by 2018-20

  • Significant drug price cut by 15-40% in many generic drugs in 2016. More pressure on API prices

  • Takeda & Teva JV could be a trendsetter as Japan pushes for generics

  • Severe scrutiny on the discrepancy between actual manufacturing operation & the process description approved by Japanese Health Authority due to the recent big scandal of the blood products in Japan

  • More and more generic companies explore business opportunities in Southeast Asia, USA, etc.

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Market in Favor of ScinoPharm

  • CRO/CMO capacities are limited in Japan for high potency substances, and many JP originators used outsourcing partners

  • To stabilize API sourcing, Japan pharmas, used to source cheaper generic APIs in India and China, switch to highquality, EHS/GMP complied vendors, like ScinoPharm

  • Via import from Taiwan and Changshu, ScinoPharm intends to timely capture the oncological API with flexibility while providing a single-source service with capability of adding additional down-stream value

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Booming Market Presence in Japan

  • As the first Taiwanese API company qualified by PMDA, ScinoPharm aims to capitalize on its qualified APIs, CRO/CMO and formulation business

  • Among 20 customers, 6 of them are top 10 drug firms include tier 1 domestic generic/brand name drug co.’s and JP operation of the global generic pharmas

A wider presence of oncology products launched. Exemestane and Irinotecan enjoy dominant positions. JP sales continue to grow this year

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Product Launch Update

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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
.
Tamsulosin
HCl
USA Benign Prostatic
Hyperplasia (BPH)
Boehringer
Ingelheim
US$410.0M US$1,818.4M

Launched

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

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uestions Q

&

Answers

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Brand Quality with Asian Advantages www.scinopharm.com

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