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SPT Investor Presentation 2017

Nov 6, 2017

51922_rns_2017-11-06_89959cbb-b446-4e1a-9cc6-665f1d5b9b2e.pdf

Investor Presentation

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1789 TT

ScinoPharm Management Presentation

2017/11/29

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

Operating Results & Business Updates

3 3

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Overview of ScinoPharm

4

ScinoPharm at a Glance

ScinoPharm specializes in high potency (steroid/cytotoxic) APIs provider and injectable formulation developer, serving customers worldwide

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

  • 73 generic APIs in current portfolio with 25 APIs launched; 55 US DMFs filed (764 DMFs WW), 33 US DMFs in oncology APIs. 100+ NCE CRAM projects, with 6 APIs launched and 3 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, Korea KFDA, Mexico COFEPRIS and German Authority

5

5

Specialty Pharmaceutical Company with Two Businesses

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Partner’s Third
Injectable Party’s
API Plant Plant
API +
ANDA
NCE
Generic
CRO+CMO
In-house
Injectable
Plant
6
28
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Driving Long Term Growth by Dual Profits

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Contract
Self-Developed
Services
Products
� Target difficult-to-make � Provide CRO/CMO for APIs
(peptide)API in our portfolio
� Offer integrated service from
� Tap into formulation
API to formulation for niche
business related to our API
injectables
core competencies
� Target 505(b)(2) and � Provide biologics fill & finish
Paragraph IV drug product contract manufacturing
via strategic alliances services
7
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World Class 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

  • In-house injectable plant with vial and cartridge production lines for oncologicals and peptides

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

  • Partnerships with downstream formulation and target for global market including China

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8

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)
9 11
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Confidential

2017 Q1-Q3 Sales Distribution

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by Region

by Business

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by Indications
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10 10

Confidential

ScinoPharm - Oncology API Leader

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Stand-Alone API Companies
ScinoPharm 32 21
Shilpa 12 11 3
Polymed 10 2 3
MacChem Products 6 5 2 # Oncology DMF Overlap with SPT
Laurus Labs 8 7 16 # Non-overlapping Oncology DMF
# Other DMFs
Sichuan Xieli 1 2 1
Chemwerth 3 5 34
Apicore 5 8 27
0 10 20 30 40 50 60
Large Generic Pharmaceutical Companies
ScinoPharm 32 21
Teva 18 28 264
Dr. Reddy's 14 13 176
Cipla 11 17 128
Sun 17 12 164
Hisun 11 19 44
# Oncology DMF Overlap with SPT
Qilu 8 3 8
# Non-overlapping Oncology DMF
Hengrui 33 11 # Other DMFs
0 50 100 150 200 250 300
11 Source: US FDA DMF Q2 2017 database
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ScinoPharm’s

Strategies and Opportunities

12

Focused To Achieve Our Goals

1.Deploying the network of development, production and distribution of injectables

  • Develop dossiers per our difficult-to-make APIs (complicated synthesis & analytical methods) plus specialized injection devices

  • Build partnerships and to achieve critical mass workforce for in-house injectable plant facility

2.CRAM has promising development potential in the next three years

  • Focus on small-molecule targeted therapies and CNS agents based on new mode of action

  • Provide integrated service from API to formulation for niche injectables

3. Active development of Emerging and Japanese market

  • Target projects to utilize capacity and accelerate growth for Changshu site

  • Develop partnership with major Japanese pharmaceutical companies and international pharmaceutical groups with Japan-based operation site

4.Continue optimizing existing generic APIs

  • Maintain the market share and profit of the top 5 marketed products

13

28

Confidential

Transforming Our Business

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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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14

Keys to Generic Formulation Business

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Opportunity Strategy Tactics
� Already the leader in � Developing dossiers per our � Expanding formulation
providing oncology APIs to difficult-to-make APIs to increase portfolio
regulated 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 un-met oncology medical needs US/EU
filing with FDA of high prevalence in Asia
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2 US ANDAs

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15
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  • 16 co-development and cost/profit sharing products with various partners

Strategic Alliance Highlights

*** Already launched**

Strategic Alliance Highlights
* Already launched
Strategic Alliance Highlights
* Already launched
Strategic Alliance Highlights
* Already launched
Strategic Alliance Highlights
* Already launched
Strategic Alliance Highlights
* Already launched
Strategic Alliance Highlights
* Already launched
Strategic Alliance Highlights
* Already launched
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
2018
1st US ANDA filing, triggering US FDA inspection in Changshu,
China site
Foresee
Leuprolide
Prostate cancer
US
2019
505(b)(2) NDA CRAM + Equity*
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 2018 1st US ANDA filing, triggering US FDA inspection in Changshu,
China site
Foresee Leuprolide Prostate cancer US 2019 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
Lee’s Pharma Fondaparinux Anti-thrombotic China 2022 Co-development collaboration
Travoprost
&Bimatoprost
Glaucoma China 2022
Nanjing King
Friend
Regadenoson Stress agent for
heart scan
China 2021 Co-developed formulation in China
US partner Project A Non-small cell lung US 2018 US NDA 505(b)(2) / The estimated launch year is subject to
16


cancer


US FDA review
US & China
partners
Project B
Imaging agent
US
2021
ANDA with Paragraph IV filing /
The estimated launch year is subject to litigation results
Baxter
5 niche injectables
Anti-cancer &
antinauseant
US/EU
2020& continuing
thereafter
Baxter has the right to add up to 15 additional injectable
products for collaboration
Indian Int’l
partner
Fondaparinux
Anti-thrombotic
US/EU
2018
1st self-developed US ANDA submitted . Executive right for
marketing & sales
cancer US FDA review
US & China
partners
Project B Imaging agent US 2021 ANDA with Paragraph IV filing /
The estimated launch year is subject to litigation results
Baxter 5 niche injectables Anti-cancer &
antinauseant
US/EU 2020& continuing
thereafter
Baxter has the right to add up to 15 additional injectable
products for collaboration
Indian Int’l
partner
Fondaparinux Anti-thrombotic US/EU 2018 1st self-developed US ANDA submitted . Executive right for
marketing & sales

In-House Injectable Plant Progress

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

  • Planned kick-off registration batch production by early 2018. Expected submission of 1st in-house ANDA in late 2018 and subsequent US FDA inspection approval 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

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28
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17

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18

Confidential

Aseptic Fill & Finish Service

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Vial
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19

Confidential

Progress of Injectable Business

Product
Oncology Injectable
Fondaparinux
Others (10 drugs)
Partner
Co-development with
Sagent
US-self development+local
marketer
Self development and
partnership
Product
Oncology Injectable
Fondaparinux
Others (10 drugs)
Partner
Co-development with
Sagent
US-self development+local
marketer
Self development and
partnership
Product
Oncology Injectable
Fondaparinux
Others (10 drugs)
Partner
Co-development with
Sagent
US-self development+local
marketer
Self development and
partnership
Product
Oncology Injectable
Fondaparinux
Others (10 drugs)
Partner
Co-development with
Sagent
US-self development+local
marketer
Self development and
partnership
Product
Oncology Injectable
Fondaparinux
Others (10 drugs)
Partner
Co-development with
Sagent
US-self development+local
marketer
Self development and
partnership
Product
Oncology Injectable
Fondaparinux
Others (10 drugs)
Partner
Co-development with
Sagent
US-self development+local
marketer
Self development and
partnership
Product Oncology Injectable Fondaparinux Others (10 drugs)
Partner Co-development with
Sagent
US-self development+local
marketer
Self development and
partnership
CN-collaboration with Lee’s
Pharma
Formulation
Production
Kindos Pharmaceuticals,
China
CMO CMO + In-house production
Type Generic Generic New Drug/Generic
Indications Myeloid Leukemia Anti-thrombotic Cancer, diabetes, osteoporosis,
mltile sclerosis and
up
antinauseant
Market Size
US: US$200M
US:US$100M/CN:US$80M
Launch Year(E)
2018
US:2018/CN:2020
After 2020
up
antinauseant
Market Size US: US$200M US:US$100M/CN:US$80M
Launch Year(E) 2018 US:2018/CN:2020 After 2020

19

20

Confidential

CRO Phase III Product Portfolio

Est. NDA
Filing Year
Indication
Region
Remarks
Est. NDA
Filing Year
Indication
Region
Remarks
Est. NDA
Filing Year
Indication
Region
Remarks
Est. NDA
Filing Year
Indication
Region
Remarks
Est. NDA
Filing Year
Indication
Region
Remarks
Est. NDA
Filing Year
Indication
Region
Remarks
Est. NDA
Filing Year
Indication Region Remarks
2018 Type I,II
Diabetes
**US/ EU ** Intermediate project made in Changshu site. Expected
revenue of several million USD per year after launch
2018 Advanced Hepatocellular
Carcinoma, Myelofibrosis,
Autoimmune disease, etc.
CN API project made in Changshu site. CFDA granted
accelerated review under its category 1.1 innovative drug.
Anticipated launch in 2019 with demand in tons
11
21
21
2018
Prostate Cancer
US / EU Started process validation. Anticipated launch in 2019
and revenue of several million USD per year
2018 Prostate Cancer **US / EU ** Started process validation. Anticipated launch in 2019
and revenue of several million USD per year

Confidential

Emerging and Japan Market Development

China

  • Accelerate progress to create positive cash flow

  • Focus on mid- to late-phase CRO projects. Current portfolio includes agents for oncology, anti-hypertension, and diabetes

  • Seek generic APIs/intermediates with large demand to increase production utilization

Japan

  • Among 20 customers, 6 are top 10 drug firms. Less established players have exited the more concentrated market

  • Encourage local generic customers to engage more in direct business

  • Support Japanese companies and foreign pharmaceutical companies to enable and extend business outreach

22

22

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

23

23

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
China pharm 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
24
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

Maintain Market Share of Existing APIs - 2016 Major Products account for 65% of total sales

API Product
Indication
2016 MKT
h
# of US DMF/EDMF &
h fili*
API Product
Indication
2016 MKT
h
# of US DMF/EDMF &
h fili*
API Product
Indication
2016 MKT
h
# of US DMF/EDMF &
h fili*
API Product
Indication
2016 MKT
h
# of US DMF/EDMF &
h fili*
API Product
Indication
2016 MKT
h
# of US DMF/EDMF &
h fili*
API Product
Indication
2016 MKT
h
# of US DMF/EDMF &
h fili*
API Product Indication 2016 MKT
h*
# of US DMF/EDMF &
h fili
sare oter ngs
Irinotecan HCI Antineoplastic 42% 63
Paclitaxel Antineoplastic 34% 57
Gemcitabine Antineoplastic 24% 76
Exemestane Antineoplastic 22% 44
Galantamine HBr Antischotic 17% 38

py


Docetaxel Anhydrous
Antineoplastic
15%
69
py
Docetaxel Anhydrous Antineoplastic 15% 69

*Source: IMS data from Newport

25

28

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Operating Results & Business Updates

26

P&L - Consolidated

In NT$ million, except for EPS
1Q~3Q,’17
(Reviewed)
1Q~3Q,’16
(Reviewed)
YoY
Operating Revenue
2,621
3,028
-13%
Gross Profit
1,203
1,362
-12%
In NT$ million, except for EPS
1Q~3Q,’17
(Reviewed)
1Q~3Q,’16
(Reviewed)
YoY
Operating Revenue
2,621
3,028
-13%
Gross Profit
1,203
1,362
-12%
In NT$ million, except for EPS
1Q~3Q,’17
(Reviewed)
1Q~3Q,’16
(Reviewed)
YoY
Operating Revenue
2,621
3,028
-13%
Gross Profit
1,203
1,362
-12%
In NT$ million, except for EPS
1Q~3Q,’17
(Reviewed)
1Q~3Q,’16
(Reviewed)
YoY
Operating Revenue
2,621
3,028
-13%
Gross Profit
1,203
1,362
-12%
In NT$ million, except for EPS
1Q~3Q,’17
(Reviewed)
1Q~3Q,’16
(Reviewed)
YoY
Operating Revenue
2,621
3,028
-13%
Gross Profit
1,203
1,362
-12%
In NT$ million, except for EPS
1Q~3Q,’17
(Reviewed)
1Q~3Q,’16
(Reviewed)
YoY
Operating Revenue
2,621
3,028
-13%
Gross Profit
1,203
1,362
-12%
In NT$ million, except for EPS
1Q~3Q,’17
(Reviewed)
1Q~3Q,’16
(Reviewed)
YoY
Operating Revenue
2,621
3,028
-13%
Gross Profit
1,203
1,362
-12%
In NT$ million, except for EPS
1Q~3Q,’17
(Reviewed)
1Q~3Q,’16
(Reviewed)
YoY
Operating Revenue
2,621
3,028
-13%
Gross Profit
1,203
1,362
-12%
In NT$ million, except for EPS
1Q~3Q,’17
(Reviewed)
1Q~3Q,’16
(Reviewed)
YoY
Operating Revenue
2,621
3,028
-13%
Gross Profit
1,203
1,362
-12%
In NT$ million, except for EPS 1Q~3Q,’17
(Reviewed)
1Q~3Q,’16
(Reviewed)
YoY
Operating Revenue 2,621 3,028 -13%
Gross Profit 1,203 1,362 -12%
Gross margin 46% 45%
Operating Expenses (744) (704) -6%
Operating Income 459 658 -30%
Operating margin 17% 22%
Other Rev.(Exp.) (61) (60) -1%
Net Income before Tax 398 598 -33%
Net Income after Tax
362
512
-29%
Net margin after tax
14%
17%
EPS (after tax)
0.46
0.65
Net Income after Tax 362 512 -29%
Net margin after tax 14% 17%
EPS (after tax) 0.46 0.65

27

27

Balance Sheet- Consolidated

In NT$ million
2017/09/30
(Reviewed)
2016/09/30
(Reviewed)
Cash and Cash Equivalents
3,950
31%
3,137
25%
At Ribl
470
4%
614
5%
In NT$ million
2017/09/30
(Reviewed)
2016/09/30
(Reviewed)
Cash and Cash Equivalents
3,950
31%
3,137
25%
At Ribl
470
4%
614
5%
In NT$ million
2017/09/30
(Reviewed)
2016/09/30
(Reviewed)
Cash and Cash Equivalents
3,950
31%
3,137
25%
At Ribl
470
4%
614
5%
In NT$ million
2017/09/30
(Reviewed)
2016/09/30
(Reviewed)
Cash and Cash Equivalents
3,950
31%
3,137
25%
At Ribl
470
4%
614
5%
In NT$ million
2017/09/30
(Reviewed)
2016/09/30
(Reviewed)
Cash and Cash Equivalents
3,950
31%
3,137
25%
At Ribl
470
4%
614
5%
In NT$ million
2017/09/30
(Reviewed)
2016/09/30
(Reviewed)
Cash and Cash Equivalents
3,950
31%
3,137
25%
At Ribl
470
4%
614
5%
In NT$ million
2017/09/30
(Reviewed)
2016/09/30
(Reviewed)
Cash and Cash Equivalents
3,950
31%
3,137
25%
At Ribl
470
4%
614
5%
In NT$ million 2017/09/30
(Reviewed)
2016/09/30
(Reviewed)
Cash and Cash Equivalents 3,950 31% 3,137 25%
At Ribl 470 4% 614 5%
ccouns ecevae
Inventories 1,830 14% 2,018 16%
Long-Term Investments 391 3% 364 3%
Property, plant and equipment 5,122 40% 5,248 42%
Other Current/Non-Current Assets 1,107 8% 1,128 9%
Total Assets 12,870 100% 12,509 100%
Current Liabilities
1,219
10%
1,534
12%
L-T Liabilities and Others
1,300
10%
880
7%
Stockholders’ Equities
10,351
80%
10,095
81%
Current Liabilities 1,219 10% 1,534 12%
L-T Liabilities and Others 1,300 10% 880 7%
Stockholders’ Equities 10,351 80% 10,095 81%

28

Cash Flows- Consolidated

In NT$ million
1Q~3Q 2017
(Reviewed)
1Q~3Q 2016
(Reviewed)
Cash and cash equivalents at beginning of period
3,707
2,336
In NT$ million
1Q~3Q 2017
(Reviewed)
1Q~3Q 2016
(Reviewed)
Cash and cash equivalents at beginning of period
3,707
2,336
In NT$ million
1Q~3Q 2017
(Reviewed)
1Q~3Q 2016
(Reviewed)
Cash and cash equivalents at beginning of period
3,707
2,336
In NT$ million
1Q~3Q 2017
(Reviewed)
1Q~3Q 2016
(Reviewed)
Cash and cash equivalents at beginning of period
3,707
2,336
In NT$ million
1Q~3Q 2017
(Reviewed)
1Q~3Q 2016
(Reviewed)
Cash and cash equivalents at beginning of period
3,707
2,336
In NT$ million
1Q~3Q 2017
(Reviewed)
1Q~3Q 2016
(Reviewed)
Cash and cash equivalents at beginning of period
3,707
2,336
In NT$ million
1Q~3Q 2017
(Reviewed)
1Q~3Q 2016
(Reviewed)
Cash and cash equivalents at beginning of period
3,707
2,336
In NT$ million 1Q~3Q 2017
(Reviewed)
1Q~3Q 2016
(Reviewed)
Cash and cash equivalents at beginning of period 3,707 2,336
Cash flows from operating activities 789 1,130
CAPEX (383) (420)
Short-term borrowings (405) (747)
Long-term borrowings 570 812
Ch Diidd 228 219
as vens
()
()
Others
(100)
245
Cash and cash equivalents at end of period
3,950
3,137
as vens () ()
Others (100) 245
Cash and cash equivalents at end of period 3,950 3,137

29

Historical Performance

Unit: millions of NT$

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5,088
4,572
5,000
4,098
3,145 3,887 3,953 3,955 4,031
4,000
3,145
2,621
3,000
2,000
1,041
872
1,040
1,000 961 1,170 1,273
635 659 362
484
0 484
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Q1-Q3
30
12
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Recent Financials

Year
2013
2014
2015
2016
Total assets
11,484 M
11,372 M
12,222 M
12,783 M
In NT$
Year
2013
2014
2015
2016
Total assets
11,484 M
11,372 M
12,222 M
12,783 M
In NT$
Year
2013
2014
2015
2016
Total assets
11,484 M
11,372 M
12,222 M
12,783 M
In NT$
Year
2013
2014
2015
2016
Total assets
11,484 M
11,372 M
12,222 M
12,783 M
In NT$
Year
2013
2014
2015
2016
Total assets
11,484 M
11,372 M
12,222 M
12,783 M
In NT$
Year
2013
2014
2015
2016
Total assets
11,484 M
11,372 M
12,222 M
12,783 M
In NT$
Year
2013
2014
2015
2016
Total assets
11,484 M
11,372 M
12,222 M
12,783 M
In NT$
Year 2013 2014 2015 2016
Total assets 11,484 M 11,372 M 12,222 M 12,783 M
Shareholders’ equity 9,643 M 9,380 M 9,857 M 10,228 M
Sales 5,088 M 4,098 M 3,955 M 4,031 M
Net profit after tax 1,273 M 484 M 635 M 659 M
Earnings per share 1.88 0.69 0.87 0.87
Cash dividends 1.2 0.2 0.3 0.3
Stock dividends 0.4 0.4 0.4 0.4
Pay-out ratio
85%
87%
80%
80%
Pay-out ratio 85% 87% 80% 80%

Note : All of the above figures represent consolidated information

31

Injectable Products Allied with Baxter

  • ScinoPharm and Baxter Healthcare establish worldwide partnerships to codevelop and commercialize five niche generic injectable products at the initial stage

  • ScinoPharm develops all APIs and injectable formulations. Baxter leads regulatory submissions in the US/EU and eventually market & sell the injectable products via its extensive presence in the hospital channel

  • Both parties work on a cost-and-profit-sharing collaboration model

  • Baxter has the right to add up to 15 additional injectable products for collaboration with ScinoPharm

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28
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32

Collaboration Framework

  • Initial product portfolio including the generic injectables for breast cancer, lung cancer, multiple myeloma and antinauseant. Targeting US/EU markets first and expect to expand to other territories

  • This exclusive partnership will utilize each other's strengths and expertise in order to achieve large scale of synergies in providing niche and affordable generic injectable products

  • Commercial launch for the first 5 products upon FDA approval, with product launches beginning in 2020 and continuing thereafter

  • Current branded sales of the initial five products included in this partnership total more than $4 billion annually

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28
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33

Responsibilities by ScinoPharm and Baxter

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API Development
API Production ScinoPharm
Formulation
Development
ScinoPharm
FDF
Baxter
Manufacturing
CMO
Sales &
Baxter
Marketing
34
28
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Benefits of the Collaboration

  • Aggressively expanding our “Double A” strategy for in-house developed/produced APIs and formulations. Providing an outlet for our injectable plant capacity

  • A win-win solution and collaboration. ScinoPharm provides comprehensive APIs and formulation portfolio, while Baxter operates strong injectable product marketing channels throughout the US and worldwide

  • Accelerate the momentum of our downstream integration strategy by establishing alliance with an world-renowned partner

35

28

2017 Product Launch Plan

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

Source: IMS Data (2015Q3-2016Q2)

Launched

36

32

Pipeline Outlook Timeline

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� 5-6 generic API launched
� US FDA inspection at Injectable plant
2018 2019 2020
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  • 3-5 generic API launched4-5 generic API launched

  • 1[st ] in-house drug US ANDA filed2 co-developed China ANDAs1[st] self-developed US ANDA launched1 co-developed US ANDA launched3 NDAs filed by CRAM customersChinese (CFDA) inspection at Changshu site

  • 37 33

Confidential

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Brand Quality with Asian Advantages

www.scinopharm.com 1789 TT

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38
38
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