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SPT Interim / Quarterly Report 2017

Aug 3, 2017

51922_rns_2017-08-03_9dad2a51-574a-426e-b352-481e46a49e73.pdf

Interim / Quarterly Report

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Ticker: TWSE 1789

Second Quarter 2017 On-Line Investor Meeting

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August 03, 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 2Q, 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 (762 DMFs WW), 32 US DMFs in oncology APIs. 100+ NCE CRAM projects, with 6 APIs launched and 4 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 1H17 were NT$1.773 billion, net profits after-tax were NT$ 255 million, gross margin was 45%, EPS was NT$0.33

  • The performances were mainly suffered by the unfavorable sales volumes and product mix of generic products in 2Q plus strongerthan-expected appreciation of the NT dollar against the US dollar in 1Q

  • CRAM business and Double A strategy started to gain momentum

  • Providing CMO service for Melinta ’s newly-approved serious skin infections drug, Baxdela™

  • Issued 2016 corporate responsibility report verified by an independent third party

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Financial & Operating Results 2Q, 2017

7 7

Quarterly P&L - Consolidated

In NT$ million, except for
EPS
2Q,’17
(Reviewed)
1Q,’17
(Reviewed)
2Q,’16
(Reviewed)
QoQ YoY
Operating Revenue 853 919 1,015 -7% -16%
Gross Profit 326 470 465 -31% -30%
Gross margin 38% 51% 46%
Operating Expenses (240) (249) (236) -4% 2%
Operating Income 86 221 229 -61% -62%
Operating margin 10% 24% 23%
Other Rev.(Exp.) (7) (29) (29) -76% -76%
Net Income before Tax 79 192 200 -59% -61%
Net Income after Tax 84 170 174 -51% -52%
8
Net margin after tax
10%
18%
17%
EPS (after tax)
0.11
0.22
0.23
-50%
-52%
Net margin after tax 10% 18% 17%
EPS (after tax) 0.11 0.22 0.23 -50% -52%

Half Year P&L - Consolidated

In NT$ million, except for EPS
1H,’17
(Reviewed)
1H,’16
(Reviewed)
YoY



In NT$ million, except for EPS
1H,’17
(Reviewed)
1H,’16
(Reviewed)
YoY



In NT$ million, except for EPS
1H,’17
(Reviewed)
1H,’16
(Reviewed)
YoY



In NT$ million, except for EPS
1H,’17
(Reviewed)
1H,’16
(Reviewed)
YoY



In NT$ million, except for EPS
1H,’17
(Reviewed)
1H,’16
(Reviewed)
YoY



In NT$ million, except for EPS
1H,’17
(Reviewed)
1H,’16
(Reviewed)
YoY



In NT$ million, except for EPS 1H,’17
(Reviewed)
1H,’16
(Reviewed)
YoY
Operating Revenue 1,773 2,037 -13%
Gross Profit 796 896 -11%
Gross margin 45% 44%
Operating Expenses (488) (471) 4%
Operating Income 308 425 -28%
Operating margin 17% 21%
Other Rev.(Exp.) (36) (34) 6%
Net Income before Tax 272 391 -30%
Net Income after Tax 255 346 -26%
9
Net margin after tax
14%
17%
EPS (after tax)
0.33
0.46
-28%
Net margin after tax 14% 17%
EPS (after tax) 0.33 0.46 -28%

Balance Sheet - Consolidated

In NT$ million 2017/6/30
(Reviewed)
2017/6/30
(Reviewed)
2016/6/30
(Reviewed)
2016/6/30
(Reviewed)
Cash and Cash Equivalents 3,721 29% 2,964 24%
Accounts Receivable 726 6% 678 5%
Inventories 1,802 14% 2,062 16%
Long-Term Investments 391 3% 364 3%
Property, plant & equipment 5,136 40% 5,355 43%
Other assets 1,105 8% 1,122 9%
Total Assets 12,881 100% 12,545 100%
Current Liabilities 1,365 11% 2,248 18%
L-T Liabilities and Others
1284
10%
339
3%
Stockholders’ Equities
10,232
79%
9,958
79%
L-T Liabilities and Others 1284 10% 339 3%
Stockholders’ Equities 10,232 79% 9,958 79%

10

Cash Flows - Consolidated

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1H 2017 1H 2016
In NT$ million
(Reviewed) (Reviewed)
Cash and cash equivalents at
3,707 2,336
beginning of period
Cash flows from operating activities 353 826
Financial assets measured at cost (27) (25)
CAPEX (324) (371)
Short-term borrowings (513) (241)
Long-term borrowings 516 255
Others 9 184
Cash and cash equivalents at
3,721 2,964
end of period
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Sales by Business

2017 1H

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BD
CMO 8%
2016 1H 8%
CRO
CRO CMO BD 8%
4% 1% <1%
Generics
76%
Generics
94%
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Sales by Indications

2017 1H

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Others
2016 1H 20%
CNS
12%
Others
Oncology
CNS
12%
68%
14%
Oncology
74%
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Sales by Region

2017 1H

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CN ROW
JP
2% 11%
7%
2016 1H
India
JP 6%
AU+NZ ROW
US+CAN
6%
3% 7%
39%
India
EU
9%
35%
US+CAN
EU
52%
23%
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Business Updates

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Confidential

ScinoPharm Will Be the API Supplier for Melinta’s Baxdela™

  • Taiwan facility will provide commercial manufacturing of API for Melinta’s Baxdela™, a new drug for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) approved by the US FDA

  • Antibiotic resistance is a growing concern, and physicians need more tools in the fight against this threat to modern medicine

  • Approximately 3 million patients hospitalized each year in the U.S. with ABSSSI often present treatment challenges owing to their underlying medical conditions, making optimal antibiotic selection difficult

16

Confidential

The New and Effective Antibiotics

  • Baxdela™ was given priority review by the US FDA due to its designation as a Qualified Infectious Disease Product (QIDP) , which is qualified for certain incentives including a five-year extension of any non-patent exclusivity period awarded to the drug

  • Melinta is also assessing Baxdela™ in a clinical trial in patients with hospital-treated community-acquired bacterial pneumonia (CABP) and planning to initiate a clinical trial in complicated urinary tract infections (cUTI) in the near future

17

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
Oncolo
Meloid
1st US ANDA filin trierin US FDA insection*
Partner
Product
Indications
Region
Launch Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Virus
Taiwan
2013
1st co-developed formulation product launch
Oncolo
Meloid
1st US ANDA filin trierin US FDA insection*
Partner
Product
Indications
Region
Launch Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Virus
Taiwan
2013
1st co-developed formulation product launch
Oncolo
Meloid
1st US ANDA filin trierin US FDA insection*
Partner
Product
Indications
Region
Launch Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Virus
Taiwan
2013
1st co-developed formulation product launch
Oncolo
Meloid
1st US ANDA filin trierin US FDA insection*
Partner
Product
Indications
Region
Launch Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Virus
Taiwan
2013
1st co-developed formulation product launch
Oncolo
Meloid
1st US ANDA filin trierin US FDA insection*
Partner
Product
Indications
Region
Launch Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Virus
Taiwan
2013
1st co-developed formulation product launch
Oncolo
Meloid
1st US ANDA filin trierin US FDA insection*
Partner
Product
Indications
Region
Launch Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Virus
Taiwan
2013
1st co-developed formulation product launch
Oncolo
Meloid
1st US ANDA filin trierin US FDA insection*
Partner
Product
Indications
Region
Launch Year(E)
Remarks
Genovate
Entecavir
Hepatitis B Virus
Taiwan
2013
1st co-developed formulation product launch
Oncolo
Meloid
1st US ANDA filin trierin US FDA insection*
Partner
Product

Indications

Region

Launch Year(E)

Remarks
Genovate Entecavir Hepatitis B Virus Taiwan 2013* 1st co-developed formulation product launch
Oncolo Meloid 1st US ANDA filin trierin US FDA insection
Sagent gy
Injectable
y
Leukemia
US 2017 g, ggg p
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 2021 Co-development collaboration
Travoprost
&Bimatoprost
Glaucoma China 2021
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
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
Niche
injectable
Anti-thrombotic
US/EU
2018
1st self-developed US ANDA launched.
Executive right for marketing & sales
18
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

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
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
API
Baxdela™ 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

Source: IMS Data (2015Q3-2016Q2)

Launched

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uestions Q

& Answers

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Brand Quality with Asian Advantages www.scinopharm.com

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