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SPT Investor Presentation 2017

Jan 9, 2017

51922_rns_2017-01-09_9f684f20-c606-4bc3-a5dc-3e666e3de6e1.pdf

Investor Presentation

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1789 TT

ScinoPharm Management Presentation 2017 JP Morgan Healthcare Conference

January 11, 2017

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.

2

2

Confidential

Table of Content

  • Overview of ScinoPharm

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ScinoPharm’s Strategies and Opportunities - Formulation Business

- China Market

  • Operating Results & Outlook

3 3

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Overview of ScinoPharm

4

Background

  • Company specializes in high potency (steroid/cytotoxic) APIs and is expanding into sterile/aseptic injectable formulations

  • Facility & organization established in Taiwan and expanding in China with a new GMP plant in Changshu & marketing base in Shanghai

  • 72 generic APIs in current portfolio with 25 APIs launched; 53 US DMFs filed (752 DMFs WW), 32 US DMFs in oncology APIs. 100+ NCE CRAM projects, with 5 APIs launched and 5 in phase III for NDA filing in 1-3 years

  • Fully compliant with world-class cGMPs and international regulatory requirements; Certified by US FDA, EMA, EDQM, Australian TGA, Japanese PMDA

5

5

World Class API Facilities

Taiwan

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

  • 5 of 16 production lines equipped with high potency capabilities for cytotoxic/steroids

  • Passed US FDA, EMA, EDQM, 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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China

  • 6.7 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 the development and production of APIs on small to large scales for generic & CRAM markets

  • Global market including China

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6

Confidential

Strong Generics Product Portfolio

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36
40 unlaunched
launched
35
30
25 23
20
13
15
7 7
10 6
13 4
5 6 2 2 2 2
6 4 3
1 2 2 2 1
0
Note: Other (Women's Health, Gastrointestinal, Immunology and Metabolic)
7 11
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Diversified CRAM Portfolio

Confidential

*** Already Filed**

Confidential
Diversified CRAM Portfolio
* Already Filed
Confidential
Diversified CRAM Portfolio
* Already Filed
Confidential
Diversified CRAM Portfolio
* Already Filed
Confidential
Diversified CRAM Portfolio
* Already Filed
Confidential
Diversified CRAM Portfolio
* Already Filed
Confidential
Diversified CRAM Portfolio
* Already Filed
Stage
First Launch Year
Indication
Market(s)
Commercial
2005
Eluting Stent
US
Commercial
2009/2013
Skin Infection/HAP
US/EU
**Stage ** First Launch Year Indication Market(s)
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 Market(s)
Phase III 2016* Infectious Disease US / EU / Asia
Phase III 2017 Ovarian Cancer US / EU
11
8
8
Phase III
2017
Prostate Cancer
US
Phase III
2017
Ovarian Cancer
CN
Phase III
2018
Parkinson’s Disease
US
Phase III 2017 Prostate Cancer US
Phase III 2017 Ovarian Cancer CN
Phase III 2018 Parkinson’s Disease US

Confidential

ScinoPharm - Oncology API Leader

Stand-Alone API Companies

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ScinoPharm 31 21
Shilpa 12 11 3
Polymed 10 2 3
MacChem Products 6 5 2 # Oncology DMF Overlap with SPT
# Non-overlapping Oncology DMF
Laurus Labs 7 7 14
# Other DMFs
Sichuan Xieli 6 8 13
Chemwerth 3 5 33
Apicore 5 6 24
0 10 20 30 40 50 60
Large Generic Pharmaceutical Companies
ScinoPharm 31 21
Teva 17 26 249
Dr. Reddy's 14 14 187
Cipla 11 17 125
Sun 17 11 174
Hisun 11 19 48 # Oncology DMF Overlap with SPT
Qilu 8 3 8 # Non-overlapping Oncology DMF
# Other DMFs
Hengrui 33 10
0 50 100 150 200 250 300
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9 Source: USFDA DMF Q3 2016 database
9
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Confidential
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2016 Sales Distribution

By Indication

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Others
12%
CNS
By Business 12%
BD&
CMO
Others
CRO 2% Oncology
<1% By Region
12% 76%
Oncology
AZ+NZ
ROW
China 63%
2%
7%
JP 4%
Generics
8%
Generic 86%
77% India
10%
US+CAN
EU
49%
20%
10
10
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ScinoPharm’s

Strategies and Opportunities

11

Confidential

We are Transforming our Company

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Transforming into a
Positioning as a
Gateway into China full-scope pharma Tightening cost control, and
process optimization with
providing Supply-Chain company by executing
enhanced management
to Multinationals
“Double A” strategy
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12

Keys to Generic Formulation Business

  • Opportunity Strategy Tactics

  • � Already the leader in providing � Developing dossiers per our � Expanding formulation oncology APIs to regulated difficult-to-make APIs to increase portfolio markets worldwide value proposition in the supply � Establishing on-site

  • � Injectable CMOs are in short chain oncology injectable facility supply � Targeted delivery & extended and providing an integrated

  • � Can be customer’s injectables release of proven APIs via supply chain provider by developing 505(b)(2) fast track � Promoting our formulations formulations using our own � Collaborating with start-ups & via strategic alliances, oncology APIs or others’ APIs, research institutes, focusing on especially in China and up to and including ANDA filing un-met oncology medical needs US/EU with FDA of high prevalence in Asia

  • 2 US ANDAs

  • 11 co-development and cost/profit sharing products with various partners

13

Strategic Alliance Highlights * Already launched

Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Virus
Taiwan
2013
1st co-developed formulation product launch
Sagent
Oncology
Injectable
Myeloid Leukemia
US
2017
1st US ANDA filing, triggering US FDA inspection in
Chanshu China site*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Virus
Taiwan
2013
1st co-developed formulation product launch
Sagent
Oncology
Injectable
Myeloid Leukemia
US
2017
1st US ANDA filing, triggering US FDA inspection in
Chanshu China site*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Virus
Taiwan
2013
1st co-developed formulation product launch
Sagent
Oncology
Injectable
Myeloid Leukemia
US
2017
1st US ANDA filing, triggering US FDA inspection in
Chanshu China site*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Virus
Taiwan
2013
1st co-developed formulation product launch
Sagent
Oncology
Injectable
Myeloid Leukemia
US
2017
1st US ANDA filing, triggering US FDA inspection in
Chanshu China site*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Virus
Taiwan
2013
1st co-developed formulation product launch
Sagent
Oncology
Injectable
Myeloid Leukemia
US
2017
1st US ANDA filing, triggering US FDA inspection in
Chanshu China site*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Virus
Taiwan
2013
1st co-developed formulation product launch
Sagent
Oncology
Injectable
Myeloid Leukemia
US
2017
1st US ANDA filing, triggering US FDA inspection in
Chanshu China site*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Virus
Taiwan
2013
1st co-developed formulation product launch
Sagent
Oncology
Injectable
Myeloid Leukemia
US
2017
1st US ANDA filing, triggering US FDA inspection in
Chanshu China site*
Partner
Product
Indications
Region
Launch
Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Virus
Taiwan
2013
1st co-developed formulation product launch
Sagent
Oncology
Injectable
Myeloid Leukemia
US
2017
1st US ANDA filing, triggering US FDA inspection in
Chanshu China site*
Partner
Product

Indications

Region

Launch
Year(E)

Remarks
Genovate Entecavir Hepatitis B Virus Taiwan 2013* 1st co-developed formulation product launch
Sagent Oncology
Injectable
Myeloid Leukemia US 2017 1st US ANDA filing, triggering US FDA inspection in
Chanshu China site
g,
Foresee Leuprolide Prostate cancer US 2018 505(b)(2) NDA CRAM + Equity
Coland Bortezomib Multiple Myeloma China 2020 1st co-developed drug in China to trigger CFDA inspection in
Changshu site
Azacitidine MDS China 2021 Co-developed formulation in China
Lee’s
Pharma
Fondaparinux Anti-thrombotic China 2021 Co-development collaboration
Travoprost
Bimatoprost
Glaucoma China 2021
14

Nanjing
King Friend
Regadenoson
Stress agent for
heart scan
China
2020
Co-developed formulation in China
US partner
Project A
Non-small cell lung
cancer
US
2018
US NDA 505(b)(2) with Paragraph IV filing / The estimated
launch year is subject to litigation results
US & China
partners
Project B
Imaging agent
US
2021
ANDA with Paragraph IV filing /
The estimated launch year is subject to litigation results
Nanjing
King Friend
Regadenoson Stress agent for
heart scan
China 2020 Co-developed formulation in China
US partner Project A Non-small cell lung
cancer
US 2018 US NDA 505(b)(2) with Paragraph IV filing / The estimated
launch year is subject to litigation results
14
US & China
partners
Project B Imaging agent US 2021 ANDA with Paragraph IV filing /
The estimated launch year is subject to litigation results

In-House Injectable Plant Progress and Outlook

  • Taiwan-based facility will accommodate R&D, Quality Control, washing, sterilization, manufacturing, filling, lyophilization, packaging, and storage.

  • Planned registration batch production by 2017. Expected to submit the first in-house ANDA in 2018 and pass US FDA inspection in 2019

  • Target products with high entry barrier or unit-pricing as in peptides and oncology agents.

  • Offering CMO services for both brand and proprietary drugs

  • Nine drug products planned in the indications of cancer, diabetes, osteoporosis, multiple sclerosis, and anti-emesis

15

28

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16

Confidential

Aseptic Fill & Finish Service

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Vial
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17

Confidential

Capturing Chinese Growth on Multiple Fronts

  • MNCs and emerging virtual-model players create a sizable demand in high-quality and compliant API contract manufacturing in China.

  • Existing review and approval mechanisms significantly raise the entry barrier and cost structure in the Chinese drug market, requiring dedication to quality and innovation.

  • We have domestic presence plus world-class strength in:

  • Global, first-tier customer base

  • High-technical-barrier oncology APIs

  • Quality and EHS/GMP compliance

18

18

Strategic Goals in China

Short Term: Pass CFDA/EMA/EDQM inspections and expand CRAM services to diversified indications & processes to optimize portfolio and capacity utilization

Mid Term: Execute API+ANDA strategy by collaborating with formulators to apply for ANDA in US/EU/CN and share profits from drug product sales globally

Long Term: Expand into new delivery formulations and new drugs via strategic alliances, investments, and M&A

19

9

Confidential

Selected List of CRAM Projects at Changshu

Confidential
Selected List of CRAM Projects at Changshu
Confidential
Selected List of CRAM Projects at Changshu
Confidential
Selected List of CRAM Projects at Changshu
Confidential
Selected List of CRAM Projects at Changshu
Confidential
Selected List of CRAM Projects at Changshu
Confidential
Selected List of CRAM Projects at Changshu
Confidential
Selected List of CRAM Projects at Changshu
Customer
Project
Type
Product Indication/stage
Product Type
Remarks/ Market
Top 10 global pharma
CMO
Approved antidepressant drug in US
GMP
Intermediate
Passed Mexican authority
(APIF) GMP inspection
Top 5 global pharma
CMO
Approved African sleeping disease drug
API
Site transfer from Taiwan
Customer Project
Type
Product Indication/stage Product Type Remarks/ Market
Top 10 global pharma CMO Approved antidepressant drug in US GMP
Intermediate
Passed Mexican authority
(APIF) GMP inspection
Top 5 global pharma CMO Approved African sleeping disease drug API Site transfer from Taiwan
Lee’s Pharma CRO / CMO >15 projects, including brain tumor, antibiotic,
hypertension, eye drops, etc.
API China
Chinapharm company CRO Phase II/ III clinical trial for cancer API China
China pharm company CRO Phase IIb for age-related macular degeneration API US/China
Taigen Biotech CRO Phase II clinical trial for myocardial infarction API China/Taiwan
US-based new drug company CRO Phase II clinical trial for prevention of HIV
infection
API US
Aslan Pharmaceuticals
CRO
Phase II clinical trial for cancer
API
China/Global
Top 5 global pharma
CRO
Phase III clinical trial for diabetes
Intermediate
US
Top 5 global pharma
CRO
Phase I clinical trial
API
NA
US NASDAQ listed pharma
CRO
Phase III clinical trial for opioid-induced
constipation
Crude API
US
US-based new drug company
CRO
Phase I clinical trial for sickle cell disease
API
US
20
Aslan Pharmaceuticals CRO Phase II clinical trial for cancer API China/Global
Top 5 global pharma CRO Phase III clinical trial for diabetes Intermediate US
Top 5 global pharma CRO Phase I clinical trial API NA
US NASDAQ listed pharma CRO Phase III clinical trial for opioid-induced
constipation
Crude API US
US-based new drug company CRO Phase I clinical trial for sickle cell disease API US

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Operating Results & Outlook

21

Historical Performance

Unit: millions of NT$

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5,088
4,572
5,000
3,887 3,953 4,098 3,955 4,031
3,791
4,000
3,145
2,494
3,000
2,000
872
613 1,041
1,273 For Q1-Q3
1,000 1,040 961 1,170
484 only
484 635
512
0
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
22
12
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Recent Financials

In NT$

Year
2013
2014
2015
Total assets
11,484 M
11,372 M
12,222 M
Year
2013
2014
2015
Total assets
11,484 M
11,372 M
12,222 M
Year
2013
2014
2015
Total assets
11,484 M
11,372 M
12,222 M
Year
2013
2014
2015
Total assets
11,484 M
11,372 M
12,222 M
Year
2013
2014
2015
Total assets
11,484 M
11,372 M
12,222 M
Year
2013
2014
2015
Total assets
11,484 M
11,372 M
12,222 M
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 1.2 0.2 0.3
Stock dividends 0.4 0.4 0.4
Pay-out ratio
85%
87%
80%
Pay-out ratio 85% 87% 80%

Note : All of the above figures represent consolidated information

23

2017 Product Launch Plan

Type
Product
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
Type
Product
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
Type
Product
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
Type
Product
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
Type
Product
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
Type
Product
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
Type
Product
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
Type
Product
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
Type
Product
Region
Indication
Brand
Marketer
Regional
Sales
WW Sales
Type Product Region Indication Brand
Marketer
Regional
Sales
WW Sales
API Desmopressin
Acetate
USA Polyuria Ferring US$166M US$405M
API Tamsulosin
HCl
USA Benign Prostatic
Hyperplasia (BPH)
Boehringer
Ingelheim
US$333M US$1706M
Generic
Drug
Oncology
Injectable
US Myeloid
Leukemia
MDS US$183M US$278M
CMO
Project
Oral
USA
EU
Antibiotics
N/A
N/A
N/A
CMO
Project
Oral USA
EU
Antibiotics N/A N/A N/A

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Source: IMS Data (2015Q3-2016Q2)
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Pipeline Outlook

  • 3-5 new launches

  • 1[st ] in-house drug US ANDA filing

  • 1[st] self-developed US ANDA launched

  • 1 co-developed US ANDA launched

  • 4-5 new launches

  • 2 co-developed China ANDAs launched

2017 2018 2019 2020

  • 2 new launches

  • 1[st] co-developed US ANDA launched

  • 5-6 new launches

  • 1 drug products launched in US

  • Chinese (CFDA) inspection at Changshu site

  • US FDA inspection at Injectable plant

25

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33
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Confidential

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Brand Quality with Asian Advantages

www.scinopharm.com 1789 TT

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