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SPT Interim / Quarterly Report 2017

May 8, 2017

51922_rns_2017-05-08_7a7f7c25-a341-4ba4-967a-91c0a65ccfb5.pdf

Interim / Quarterly Report

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Ticker: TWSE 1789

First Quarter 2017 On-Line Investor Meeting

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May 08, 2017

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 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 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 Contents

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Overall Updates of ScinoPharm

Financial & Operating Results in Q1, 2017

  • Business Updates

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Overall Updates of ScinoPharm

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4 4

Confidential

Business Overview

  • 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 (759 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

Recap of Performances and Major Events

  • Reported the consolidated revenues for 1Q17 were NT$919 million, net profits after-tax were NT$ 170 million, gross margin was 51%, EPS was NT$0.22

  • The revenues was suffered by the stronger-than-expected appreciation of the NT dollar against the US dollar. However, the impact was offset by tighter cost control and process optimization

  • Building exclusive strategic partnership with Baxter for generic oncology injectables

  • Taiwan site completed the 6[th] times US FDA inspection with no resulting 483 concerns

  • On schedule to carry out equipment assembly and installation for both cartridge and vial production lines, followed by verification and cGMP system deployment

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Financial & Operating Results Q1, 2017

7 7

Quarterly P&L - Consolidated

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Q1, 2017 Q1, 2016
In NT$ million, except for EPS YoY
(Reviewed) (Reviewed)
Operating Revenue * 919 1,022 -10%
Gross Profit 470 431 9%
Gross margin 51% 42%
Operating Expenses (249) (236) 6%
Operating Income 221 195 13%
Operating margin 24% 19%
Other Rev. (Exp.) (29) (4)
Net Income before Tax 192 191 1%
Net Income after Tax 170 172 -1%
Net margin after tax 19% 17%
EPS (after tax) 0.22 0.23

Taiwan New Dollar per 1 US Dollar quarterly average:
2017Q1: 30.93, 2016Q1: 33.16
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Balance Sheet- Consolidated

In NT$ million 2017/03/31
(Reviewed)
2017/03/31
(Reviewed)
2016/03/31
(Reviewed)
2016/03/31
(Reviewed)
Cash and Cash Equivalents 3,715 29% 2,560 21%
Accounts Receivable 635 5% 645 5%
Inventories 1,941 15% 2,167 17%
Long-Term Investments 364 3% 364 3%
Property, Plant & Equipment 5,155 40% 5,361 43%
Other Current/Non-Current Assets 1,043 8% 1,394 11%
Total Assets 12,853 100% 12,491 100%
Current Liabilities 1,692 13% 2,374 19%
Long-Term & Other Liabilities 803 6% 90 1%
Stockholders’ Equities 10,358 81% 10027 80%
,

Cash Flows- Consolidated

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Q1, 2017 Q1, 2016
In NT$ million
(Reviewed) (Reviewed)
Cash and cash equivalents
3,707 2,336
at beginning of period
Cash flows from operating activities 304 663
CAPEX (203) (264)
Short-term borrowings (51) (16)
-
Long-term borrowings (41)
Others (1) (159)
Cash and cash equivalents
3,715 2,560
at end of period
Free Cash flow 101 399
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Sales by Business

2017 Q1

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BD&
CMO other
2016 Q1
8% 6%
CRO
5%
CMO BD
CRO
1% 1%
6%
Generics
81%
Generics
92%
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Sales by Indications

2017 Q1

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Others
12%
2016 Q1 CNS
11%
Others
Oncology
CNS 14%
77%
11%
Oncology
75%
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Sales by Region

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2016 Q1
CN ROW
JP
<1% 10%
8%
India
3%
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2017 Q1

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JP
CN ROW
8%
2% 5%
India
5%
US+CAN
EU
44%
36%
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Business Updates

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Confidential

Injectable Products Allied with Baxter

  • ScinoPharm and Baxter Healthcare establish worldwide partnerships to co-develop 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 injectables products for collaboration with ScinoPharm

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Confidential

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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Marketing Territory

  • All countries throughout the world, excluding China and Taiwan

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Responsibilities by ScinoPharm and Baxter

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API Development
API Production
ScinoPharm
Formulation
Development
ScinoPharm
FDF Baxter
Manufacturing
CMO
Sales &
Baxter
Marketing
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FDF: Finished Dosage Form
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Confidential

Benefits of the Collaboration

  • Aggressively expanding our “Double A” strategy for inhouse 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

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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

Myeloid

US
2017
1st US ANDA filing, triggering US FDA inspection*
Partner
Product

Indications

Region

Launch Year(E)

Remarks
Genovate Entecavir Hepatitis B Virus Taiwan 2013* 1st co-developed formulation product launch
Sagent Oncology
Myeloid
US 2017 1st US ANDA filing, triggering US FDA inspection
Injectable Leukemia 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
Azacitidine MDS China 2021 Co-developed formulation in China
Lee’s
Pharma
Fondaparinux Anti-thrombotic China 2021 Co-development collaboration
Travoprost Glaucoma China 2021
&Bimatoprost
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 2017 US NDA 505(b)(2) / The estimated launch year
is subject to US FDA review
US &
China
Project B Imaging agent US 2021 ANDA with Paragraph IV filing /
The estimated launch year is subject to
partners

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
Niche
injectable
Anti-thrombotic
US/EU
2018
1st self-developed US ANDA launched.
Executive right for marketing & sales
20
partners 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
Niche
injectable
Anti-thrombotic US/EU 2018 1st self-developed US ANDA launched.
Executive right for marketing & sales

Confidential

CRO Phase III Product Portfolio

*** Already Filed**

Code
Est. NDA

Indication
Sales Region
Production Site
Code
Est. NDA

Indication
Sales Region
Production Site
Code
Est. NDA

Indication
Sales Region
Production Site
Code
Est. NDA

Indication
Sales Region
Production Site
Code
Est. NDA

Indication
Sales Region
Production Site
Code
Est. NDA

Indication
Sales Region
Production Site
Code
Est. NDA

Indication
Sales Region
Production Site
Code Est. NDA
Indication Sales Region Production Site
Filing Year
A 2016* Infectious Disease US / EU
/ Asia
Taiwan
B 2018 Type I,II
Diabetes
US/ EU Changshu
(Intermediate)
C 2018 Advanced Hepatocellular
Carcinoma/ Myelofibrosis/
Autoimmune disease, etc.
CN Changshu
D 2018 Prostate Cancer US / EU Taiwan
E
2018
Parkinson’s Disease
US
Taiwan
E 2018 Parkinson’s Disease US Taiwan

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2017 Product Launch Plan

Type
Product
Region
Indication
Brand

Regional

WW
Type
Product
Region
Indication
Brand

Regional

WW
Type
Product
Region
Indication
Brand

Regional

WW
Type
Product
Region
Indication
Brand

Regional

WW
Type
Product
Region
Indication
Brand

Regional

WW
Type
Product
Region
Indication
Brand

Regional

WW
Type
Product
Region
Indication
Brand

Regional

WW
Type
Product
Region
Indication
Brand

Regional

WW
Type
Product
Region
Indication
Brand

Regional

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

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Source: IMS Data (2015Q3-2016Q2)
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uestions Q

& Answers

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Brand Quality with Asian Advantages www.scinopharm.com

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