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20160927 ScinoPharm for Citi

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TWSE 1789 Company Presentation
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Page 1: 20160927 ScinoPharm for Citi

TWSE 1789

Company Presentation

Page 2: 20160927 ScinoPharm for Citi

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 orcompleteness of this material and any liability therefore is hereby expressly disclaimed.

Statements made in this presentation 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 andunknown risks, uncertainties and other factors which may cause actual results to differmaterially from those implied by such forward-looking statements.

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Page 3: 20160927 ScinoPharm for Citi

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Overview of ScinoPharm

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Page 4: 20160927 ScinoPharm for Citi

Confidential

Business Overview

� Company specializes in high potency (steroid/cytotoxic) APIs and

is expanding into sterile/aseptic injectable formulations

� Facility & organization built in Taiwan and expanding in China

with a new GMP plant in Changshu & marketing base in Shanghai

� 70 generic APIs in current portfolio with 25 APIs launched; 51 US

DMFs filed (741 DMFs WW), 30 US DMFs in oncology APIs.

100+ NCE CRAM projects, with 5 APIs launched and 5 in phase III

for NDA filing in 2-3 years

� Fully compliant with world-class cGMPs and international

regulatory requirements; Certified by US FDA, EMA, Australian

TGA, Japanese PMDA.

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Page 5: 20160927 ScinoPharm for Citi

World Class API FacilitiesTaiwan China

� 6.6 hectares of land, 330K sqft facilities with >200M3 reactor volume

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

� Passed US FDA, EMA, Australian TGA, Japanese PMDA inspections & 300+ cGMP customer audits

� Provides comprehensive contract research & manufacturing services for Brand drug companies

� Global Market served

� 6.5 hectares of land with > 250M3 reactor volume

� 3 of 7 production lines equipped with high potency capabilities for cytotoxics

� US FDA approved cGMP facility for intermediates & high potency APIs

� Full scope capabilities in developing and producing APIs from small to large scale for generic & CRAM markets

� Global market served including China

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Page 6: 20160927 ScinoPharm for Citi

Strong Generics Product Portfolio

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0

5

10

15

20

25

30

35

40

13

61

41

23

5

6 2

2 2 23

unlaunched

launched

2 2

62

7

11

36

4

Note: Other (Women's Health, Gastrointestinal, Immunology and Metabolic)

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Page 7: 20160927 ScinoPharm for Citi

ScinoPharm - Oncology API Leader

Source: US FDA DMF Q1 2016 database

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3

6

7

7

10

12

30

6

5

8

7

5

2

11

23

32

13

11

2

3

2

20

0 10 20 30 40 50 60

Apicore

Chemwerth

Sichuan Xieli

Laurus Labs

MacChem Products

Polymed

Shilpa

ScinoPharmStand-Alone API Companies

# Oncology DMF Overlap with SPT# Non-overlapping Oncology DMF# Other DMFs

6

3

8

11

17

11

15

15

30

3

3

19

11

16

13

26

9

8

48

170

128

189

247

20

0 50 100 150 200 250 300

Hengrui

Qilu

Hisun

Sun

Cipla

Dr. Reddy's

Teva

ScinoPharmLarge Generic Pharmaceutical Companies

# Oncology DMF Overlap with SPT# Non-overlapping Oncology DMF# Other DMFs

Page 8: 20160927 ScinoPharm for Citi

Expanding into formulation

business, combined with the

synergy of our API business,

to maximize ROI

Tightening cost control,

process optimization

with enhanced

management

Tapping into formulation

space related to our core

competencies in high-entry-

barrier APIs

Transforming into a full-scope pharma

company by executing “Double A” strategy

Positioning as a

Gateway into China

as a Supply-Chain

for Multinationals

We are Transforming our Company

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Page 9: 20160927 ScinoPharm for Citi

Keys to Generic Formulation Business

StrategyOpportunity Tactics

� Developing dossiers per our

difficult-to-make APIs to

increase value proposition

in the supply chain

� Targeted delivery &

extended release of proven

APIs via 505(b)(2) fast track

� Collaborating with start-ups

& research institutes,

focusing on un-met

oncology medical needs of

high prevalence in Asia

� Expanding formulation

portfolio

� Establishing on-site

oncology injectable

facility and providing

an integrated supply

chain

� Promoting our

formulations via

strategic alliances,

especially in China and

US/EU

� 2 US ANDAs

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

Results

� Already the leader in

providing oncology APIs

to regulated markets

worldwide

� Injectable CMOs are in

short supply

� Can be customer’s

injectables provider by

developing formulations

using our own oncology

APIs or others’ APIs, up to

and including ANDA filing

with FDA

8

Page 10: 20160927 ScinoPharm for Citi

Strategic Alliance Highlights * Already launched

9

Partner Product Indications RegionLaunch Year(E)

Remarks

Genovate Entecavir Hepatitis B Viral Taiwan 2013* 1st co-developed formulation product launch

Sagent Oncology Injectable

Myeloid Leukemia US 20171st US ANDA filing, triggered US FDA inspection in Changshu site

Foresee Leuprolide Prostate cancer US 2018 505(b)(2) NDA CRAM + Equity

ColandBortezomib

Multiple Myeloma

China 20201st 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 2020

Nanjing King Friend

RegadenosonStress agent for

heart scanChina 2020 Co-developed formulation in China

US partner

Project Anon-small cell

lung cancerUS 2020

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 2020ANDA with Paragraph IV filing / The estimated launch year is subject to litigation results

Page 11: 20160927 ScinoPharm for Citi

10

Operating Results & Outlook

Page 12: 20160927 ScinoPharm for Citi

Historical Performance

11

Unit: In NT$ million

484

1,463

143

2,494

613

3,145

872

3,791

1,041

3,887

1,040

3,953

961

4,572

1,170

5,088

1,273

4,098

484

3,955

635

0

1,000

2,000

3,000

4,000

5,000

2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Page 13: 20160927 ScinoPharm for Citi

Recent Financials

12

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%

In NT$

Note : All of the above figures represent consolidated information

Page 14: 20160927 ScinoPharm for Citi

13

Quarterly P&L - Consolidated

In NT$ million, except for EPS

2Q,’16(Reviewed)

1Q,’16(Reviewed)

2Q,’15(Reviewed)

QoQ YoY

Operating Revenue 1,015 1,022 963 -1% 5%

Gross Profit 465 431 365 8% 27%

Gross margin 46% 42% 38%

Operating Expenses (236) (236) (239) 0% -1%

Operating Income 229 195 126 17% 82%

Operating margin 23% 19% 13%

Other Rev.(Exp.) (29) (4) 106 625% -127%

Net Income before Tax 200 191 232 5% -14%

Net Income after Tax 174 172 132 1% 32%

Net margin after tax 17% 17% 14%

EPS (after tax) 0.24 0.24 0.18 0% 33%

Page 15: 20160927 ScinoPharm for Citi

14

Half Year P&L - Consolidated

In NT$ million, except for EPS1H,’16

(Reviewed)1H,’15

(Reviewed)YoY

Operating Revenue 2,037 1,942 5%

Gross Profit 896 709 26%

Gross margin 44% 37%

Operating Expenses (471) (442) 7%

Operating Income 425 267 59%

Operating margin 21% 14%

Other Rev.(Exp.) (34) 99 -134%

Net Income before Tax 391 366 7%

Net Income after Tax 346 245 41%

Net margin after tax 17% 13%

EPS (after tax) 0.47 0.34 38%

Page 16: 20160927 ScinoPharm for Citi

15

Balance Sheet - Consolidated

In NT$ million2016/6/30

(Reviewed)2015/6/30

(Reviewed)

Cash and Cash Equivalents 2,964 24% 2,410 20%

Accounts Receivable 678 5% 568 5%

Inventories 2,062 16% 2,315 19%

Long-Term Investments 364 3% 339 3%

Property, plant & equipment 5,355 43% 5,142 43%

Other assets 1,122 9% 1,100 10%

Total Assets 12,545 100% 11,874 100%

Current Liabilities 2,248 18% 2,333 19%

L-T Liabilities and Others 339 3% 91 1%

Stockholders’ Equities 9,958 79% 9,450 80%

Page 17: 20160927 ScinoPharm for Citi

In NT$ million 1H 2016(Reviewed)

1H 2015(Reviewed)

Cash and cash equivalents atbeginning of period 2,336 1,928

Cash flows from operating activities 826 589

CAPEX (371) (345)

Short-term borrowings (241) 212

Long-term borrowings 255 -

Others 159 26

Cash and cash equivalents at end of period 2,964 2,410

Cash Flows - Consolidated

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Page 18: 20160927 ScinoPharm for Citi

2015 1H

2016 1H Sales by Business

Generics

94%

CRO

4%

CMO

1%

BD

<1%

Generics

89%

CRO

7%

CMO

2%

BD

2%

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Page 19: 20160927 ScinoPharm for Citi

2016 1H

Oncology

60%

18

Oncology

74%

CNS

14%

Others

12%

Oncology

79%

CNS

14%

Others

7%

Sales by Indication

2015 1H

Page 20: 20160927 ScinoPharm for Citi

2016 1H

US+CAN

52%EU

23%

India

9%

JP

6%AU+NZ

3%

ROW

7%

US+CAN

43%EU

19%

India

19%

JP

7%

AU+NZ

5%

ROW

7%

19

Sales by Region

2015 1H

Page 21: 20160927 ScinoPharm for Citi

20

ScinoPharm Changshu

Operation Update

Page 22: 20160927 ScinoPharm for Citi

Near-Term Objectives

� Provide API contract development and

manufacturing services for both multinational

and China domestic pharmas

� Serve as major base for large volume API

manufacturing with regulatory support

� Produce high value-added intermediates for

ScinoPharm Taiwan

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Page 23: 20160927 ScinoPharm for Citi

� Process Development CapabilityCollaborating with a partner specializing in enzymatic technology to

integrate with ScinoPharm CMC capabilities to develop greener, safer, and

more cost-effective API manufacturing processes

� GMP Production CapabilityKnowledge to design, develop, and test spray-drying process parameters for

APIs which are difficult-to-dry, are sensitive to long drying residence time,

or require uniform particle size distribution

� Regulatory Compliance CapabilityFully compliant with the most advanced EMA guidelines to meet or exceed

standards for production line segregation and equipment cleaning criteria

22

Our Competitive Advantage

Page 24: 20160927 ScinoPharm for Citi

� Actively implementing more than 20 contract research

or manufacturing projects every year

� 9 US/EU customers, 3 of which are top 10 big pharma

� Strategic 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 customer-led

audits

23

Operations Progress

Page 25: 20160927 ScinoPharm for Citi

Selected CRAM Projects at Changshu

24

CustomerProject

TypeProduct 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 APISite transfer

from Taiwan

Lee’s Pharma CRO

+15 items including topical anesthetic,

brain tumor, antibiotic, hypertension, eye

drop, etc.

API China

China pharm company CRO Phase II/ III clinical trial for cancer API China

China pharm company CROPhase IIb for age-related macular

degenerationAPI US/China

Taigen Biotech CROPhase II clinical trial for myocardial

infarctionAPI China/Taiwan

US-based new drug company CROPhase II clinical trial for prevention of HIV

infectionAPI US

Top 5 global pharma CRO Phase II clinical trial for diabetes Intermediate US

Top 5 global pharma CRO Phase I clinical trial API NA

US NASDAQ listed pharma CROPhase III clinical trial for opioid-induced

constipationCrude API US

Page 26: 20160927 ScinoPharm for Citi

Key Progress for the China Market

25

ScinoPharm

Taiwan

Submitted drug import license applications for 12

APIs (e.g. anti-cancer, cardiovascular, Alzheimer's

disease, benign prostatic hyperplasia, hepatitis B)

ScinoPharm

Changshu

• 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

Strategic

Alliance

5 formulation development and 1 new drug

projects smoothly ongoing. Expected

commercialization in 2019-2022

Page 27: 20160927 ScinoPharm for Citi

26

Business Updates

Page 28: 20160927 ScinoPharm for Citi

Injectable Plant Progress

27

� Entire facility includes space for R&D, quality control, washing, sterilization, manufacturing, filling, lyophilization, packaging, and storage.

� Granted building use permit at the end of 2015. Planned registration batch production by 2017. Expected to submit the 1st in-house ANDA in 2018 and pass US FDA inspection in 2019.

� Targeting injectables with high entry barrier / high unit-priced generics like oncology agents and peptides. Will offer CMO services for brand drugs and proprietary drugs.

� 10 drug products planned in the indications of cancer, diabetes, osteoporosis, multiple sclerosis, and anti-emesis.

Page 29: 20160927 ScinoPharm for Citi

Aseptic Fill & Finish Service

Vial

Product Line

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Page 30: 20160927 ScinoPharm for Citi

Diversified CRAM Portfolio

11

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 2016 Infections US / EU / Asia

Phase III 2017 Ovarian Cancer US / EU

Phase III 2017 Prostate Cancer US

Phase III 2017 Ovarian Cancer CN

Phase III 2018 Parkinson’s Disease US

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Page 31: 20160927 ScinoPharm for Citi

2016 1H Major Products- accounts for 60% of total sales

*Source: IMS data from Newport

30

API Indications2015 MKT

Share# of US DMF/EDMF &

other Filings

Irinotecan HCI

Antineoplastic 64% 62

Docetaxel Anhydrous

Antineoplastic 33% 68

Paclitaxel Antineoplastic 31% 57

Exemestane Antineoplastic 18% 44

Galantamine HBr

Antipsychotic 12% 38

Gemcitabine Antineoplastic 8% 76

Page 32: 20160927 ScinoPharm for Citi

2016 API Product Launch Plan

Launched

31

Source: IMS Data (2014Q4-2015Q3)

API Region IndicationBrand

MarketerRegional

SalesWW Sales

Azacitidine USAMyelodysplasticsyndrome (MDS)

Celgene US$248.1M US$751.6M

Desmopressin

AcetateUSA Polyuria Ferring US$150.1M US$395.8M

EntecavirUSA

Singapore

Australia

Hepatitis B

Virus (HBV) Bristol-Myers

US$262.5M (USA only) US$1,576.6M

Flumazenil Korea

Reversal of the sedative effects ofbenzodiazepines

Roche N/A US$84.0M

Gemcitabine HClMiddle

East

Pancreas, Lung, Ovary, and Breast

Cancers.Eli Lilly N/A US$547.9M

Tamsulosin HCl USABenign Prostatic

Hyperplasia (BPH)

Boehringer

IngelheimUS$410.0M US$1,818.4M

Page 33: 20160927 ScinoPharm for Citi

Pipeline

2016 2017 2018 2019 2020

� 4-6 new launches � 5-6 new launches

� 1st in-house drug

US ANDA filing

� 5-6 new launches

� 3 drug products launched in China

� 1st in-house drug launched in US

� 3-5 new launches

� 1st self-developed US

ANDA launched

� 6-8 new launches

� Chinese CFDA inspection at SPC

� US FDA inspection at INJ

� 1st co-developed US

ANDA launched

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Page 34: 20160927 ScinoPharm for Citi

Brand Quality with Asian Advantagewww.scinopharm.com

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