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SPT Investor Presentation 2015

Oct 8, 2015

51922_rns_2015-10-08_5afc7c28-ec2a-4ce4-a3a8-d6fc7737561a.pdf

Investor Presentation

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TWSE 1789

ScinoPharm Management Presentation

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.

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2

Confidential

Table of Content

  • Overview of ScinoPharm

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  • ScinoPharm’s Strategies and Opportunities

Operating Results & Outlook

3

3

Overview of ScinoPharm - an API + ANDA Company

Active Pharmaceutical Ingredients Abbreviated New D A rug pplication

Background

  • Established in 1997 in Taiwan and listed on TWSE in 2011, current market cap around US$830 million

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

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

  • Specializes in high potency (steroid/cytotoxic) APIs and expands to injectable formulations

  • Expanding in China with a new GMP plant in Changshu & marketing base in Shanghai

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5

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 cytotoxics/steroids

  • US FDA approved & 250+ CGMP audits by customers

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

  • Global Market

China

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

  • 2 of 8 production lines equipped with high potency capabilities for cytotoxics

  • cGMP designed facility for intermediates & high potency API

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

  • Global market including China

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6

Confidential

Business Overview

Risk & return balanced model to offer APIs and fill/finish capability for both generic and new drugs

  • 70 generic APIs developed with 27 APIs launched; 50 US DMFs filed (711 DMFs WW), 24 US DMFs in oncological APIs

80+ NCE CRAM projects, with 5 launched and 7 in phase III for NDA filing in 2-3 years; Qualified Asian supplier to provide APIs to global market for multiple commercial NCEs

7 7

7

Confidential

Strong Generics Product Portfolio

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Sales Breakdowns

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Confidential
By Indication
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By Business

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By Region
Generic
77%
1H 2015
9
9
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Confidential

Oncology as Worldwide Top 1 Therapy

Source: Evaluate Pharma

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Confidential

ScinoPharm – Global Oncological API Leader

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Confidential

Targeted Therapy Dominates Oncology

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Supportive care
1%
Protein
Kinase
Immunotherapy Inhibitor
23% Targeted
60%
therapy
Hormonal
60%
therapy
14% mAb
20%
ADC 11%
Chemotherapy
Others 9%
2% Source: 2020 Sales Forecast, Global Data
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Confidential
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ScinoPharm Pipeline Echoes Therapy Trend

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Supportive
care 5%
Genito Urinary System & Ophthalmology Hematological
Sex Hormones 2% 2% disorder 2%
Respiratory 4%
Gastrointestinal 5%
Hormonal
therapy
Infectious disease
21%
8%
Oncology
36%
Targeted
Cadiovascular 8%
therapy
74%
Immunology
10%
Metabolic
CNS disorder 13%
10%
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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 2014 Infections US
Phase III 2016 Prostate & Ovarian Cancer EU
~~11~~
14
Phase III
2017
Prostate Cancer
US
Phase III
2016-2017
Ovarian Cancer
CN
Phase III
2017
Seizure
US
Phase III
2017
Parkinson’s Disease
US
Phase III
2017
Opioid-Induced Constipation
US
14
Phase III 2017 Prostate Cancer US
Phase III 2016-2017 Ovarian Cancer CN
Phase III 2017 Seizure US
Phase III 2017 Parkinson’s Disease US
Phase III 2017 Opioid-Induced Constipation US

Strategic Alliances for Formulation

*** 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 Oncological
Injectable
Myeloid Leukemia US 2016 1st US ANDA filing to trigger 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
Azacitidine MDS China 2019 Co-developed formulation
Lee’s Pharma
Fondaparinux
Anti-thrombotic
China
2019
1st self-developed drug in China
Travoprost
Bimatoprost
Glaucoma
China
2020
Co-developed formulations
Nanjing King
Friend
Regadenoson
Stress agent for heart
scan
China
2020
1st type 3.1 co-developed new drug in
China
Lee’s Pharma Fondaparinux Anti-thrombotic China 2019 1st self-developed drug in China
Travoprost
Bimatoprost
Glaucoma China 2020 Co-developed formulations
Nanjing King
Friend
Regadenoson Stress agent for heart
scan
China 2020 1st type 3.1 co-developed new drug in
China

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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 academic research institutes, focusing on un-met oncological medical needs of high prevalence in Asia

17

Keys to Generic Formulation Business

  • Expanding formulation portfolio: Two US ANDA filed

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

  • Acquiring critical resources via M&A

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

18

Confidential

Golden Opportunities in China

  • Government’s strong support carrying into 13[th] five-year plan to encourage pharma industry’s CAGR of 20%

  • Tighten GMP requirements to align with US/EU

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

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

  • ScinoPharm timely captures oncological API needs via importing from Taiwan and local made in Changshu sites

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19

Policy Reforms to Expedite Drug Approvals

  • Redefine new drugs and generics in China

  • Elevate the overall quality and efficacy requirements of submissions

  • Encourage innovative drugs via fast track approval

  • Allow new drug developers to own drug licenses without manufacturing sites

  • Clear the application backlog by discouraging redundant filings and fee raises

  • Impose severe penalties on fraudulent data/activities on research & trials

This reform will significantly lift the cost structure & entry barrier to Chinese market, with a heavy focus on quality and innovation

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8

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Operating Results & Outlook

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Half Year P&L - Consolidated

In NT$ million, except for EPS
1H,’15
(Reviewed)
1H,’14
(Reviewed)
YoY
Net Sales
1,942
2,245
-13%
In NT$ million, except for EPS
1H,’15
(Reviewed)
1H,’14
(Reviewed)
YoY
Net Sales
1,942
2,245
-13%
In NT$ million, except for EPS
1H,’15
(Reviewed)
1H,’14
(Reviewed)
YoY
Net Sales
1,942
2,245
-13%
In NT$ million, except for EPS
1H,’15
(Reviewed)
1H,’14
(Reviewed)
YoY
Net Sales
1,942
2,245
-13%
In NT$ million, except for EPS
1H,’15
(Reviewed)
1H,’14
(Reviewed)
YoY
Net Sales
1,942
2,245
-13%
In NT$ million, except for EPS
1H,’15
(Reviewed)
1H,’14
(Reviewed)
YoY
Net Sales
1,942
2,245
-13%
In NT$ million, except for EPS 1H,’15
(Reviewed)
1H,’14
(Reviewed)
YoY
Net Sales 1,942 2,245 -13%
Gross Profit 709 933 -24%
Gross margin 37% 42%
Operating Expenses (442) (538) -18%
Operating Income 267 395 -32%
Operating margin 14% 18%
Other Rev.(Exp.) 99
2

4850%
Net Income before Tax 366 397 -8%
Net Income after Tax 245 358 -32%
Net margin after tax 13% 16%
EPS (after tax) 0.35 0.51 -31%

22

Balance Sheet - Consolidated

In NT$ million
2015/6/30
(Reviewed)
2014/6/30
(Reviewed)
Cash and Cash Equivalents
2,410
20%
2,184
18%
In NT$ million
2015/6/30
(Reviewed)
2014/6/30
(Reviewed)
Cash and Cash Equivalents
2,410
20%
2,184
18%
In NT$ million
2015/6/30
(Reviewed)
2014/6/30
(Reviewed)
Cash and Cash Equivalents
2,410
20%
2,184
18%
In NT$ million
2015/6/30
(Reviewed)
2014/6/30
(Reviewed)
Cash and Cash Equivalents
2,410
20%
2,184
18%
In NT$ million
2015/6/30
(Reviewed)
2014/6/30
(Reviewed)
Cash and Cash Equivalents
2,410
20%
2,184
18%
In NT$ million
2015/6/30
(Reviewed)
2014/6/30
(Reviewed)
Cash and Cash Equivalents
2,410
20%
2,184
18%
In NT$ million
2015/6/30
(Reviewed)
2014/6/30
(Reviewed)
Cash and Cash Equivalents
2,410
20%
2,184
18%
In NT$ million 2015/6/30
(Reviewed)
2014/6/30
(Reviewed)
Cash and Cash Equivalents 2,410 20% 2,184 18%
Accounts Receivable 568 5% 793 7%
Inventories 2,315 19% 2,676 23%
Long-Term Investments 339 3% 255 2%
Property, plant & equipment 5,142 43% 4,658 40%
Other assets 1,100 10% 1,229 10%
Total Assets 11,874 100% 11,795 100%
Current Liabilities 2,333 19% 2,569 22%
L-T Liabilities and Others 91 1% 66 0%
Stockholders’ Equities 9,450 80% 9,160 78%

23

Cash Flows - Consolidated

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1H 2015 1H 2014
In NT$ million
(Reviewed) (Reviewed)
Cash and cash equivalents at
1,928 2,289
beginning of period
Cash flows from operating activities 589 248
CAPEX (345) (694)
Short-term borrowings 212 317
Others 26 24
Cash and cash equivalents at
2,410 2,184
end of period
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24

2015 Product Launch Plan

API Region Indications Brand Marketer Regional Sales WW Sales
Azacitidine US MDS Oncology Celgene US$323MM* US$815MM*
Benazepril CN Hypertension, CV Novartis US$65MM** US$480MM*
Desmopressin US Polyuria Ferring US$131MM* US$395MM*
Letrozole JP Breast Cancer Novartis US$51MM** US$581MM*
Tamsulosin US Benign prostatic
hyperplasia (BPH)
Boehringer
Ingelheim
US$335MM* US$1,829MM*
Launched
Source: * IMS Data (2013Q3-2014Q2) ** In-house research
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Pipeline Outlook

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� 4-5 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
2015 2016 2017 2018 2019 2020
� 3-5 new launches � 4-5 new launches � 6-8 new launches
� SPC US FDA inspection � 1 [st] self-developed US � SPC China FDA inspection
� 1 [st] self-developed US ANDA launched � 3 drug products launched in China
ANDA filing � 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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