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SPT Interim / Quarterly Report 2020

Aug 13, 2020

51922_rns_2020-08-13_58d63445-33c2-47bb-b4d1-3cb2b1a48740.pdf

Interim / Quarterly Report

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1789 TT

ScinoPharm

August 13, 2020

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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Table of Content

Business Overview

Business Update

2020 Product Approval Plan

Operating Results

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Business Overview

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A. The achievements from three major business are being progressed

1H 2020 revenue NTD 1,451 million with YoY 4%;net profit NTD 197 million with YoY 45% and net margin to be 13.61%

Business Generic API Drug Product CDMO
Achievements 1.The market presence
of our core products
is being enlarged with
aggressive sales
approach and
production advantage
utilization
2.With the credentials
earned and facility
flexibility established,
we have branched
out into Japan and
China markets
1.Several drug products
are in developing upon
our capability in API
development
2.ANDA of 1st in-house
prefilled-syringe
product has been
submitted to FDA in
May
3.Registration batches of
Cartridge product and
Vial product have been
completed in March
and under processing
respectively
1.One CDMO
product (new
drug MAA) has
been approved
by EMA
2.Two CDMO
products have
been submitted
to EMA and
FDA by
customers

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B. The facilities cross-strait are being further integrated to provide flexibility for market dynamic

Keep on enhancing the connection and collaboration between Tainan and Changshu

To response to market dynamic

In the post-pandemic period, given the possible change in market segmentation and supply, we focus on fulfilling customers’ demand for FDA/CFDA dual filing and thus expanding API business under MAH regulation

To utilize the two facilities

The resource allocation is being made under consideration of product attributes and two sites’ production advantages C. DMFs are being accumulated for business potential73 generic APIs in portfolio with 31 referred and approved by ANDA/NDA. 853 active DMFs worldwide with 63 US DMFs

Data as of 2020/06/30

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Business Update

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Business Strategies

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Advancing to
Injectables
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Optimize
Existing Generic
API Portfolio
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Expand CDMO
Business
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Actively Develop Japan, China and Emerging Markets
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Advancing to Injectables

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Oral Solids
Extended Release
Oral Solids
Immediate Release
APIs
Dermatological
Semi-Solids
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Peptides
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Sterile
Injectables
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Pen Injectors
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Otics & Opthalmics Respiratory Devices

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Higher entry barriers due to more tech, IP and regulatory requirements
lead to more value
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In-House Injectables Portfolio

Expected TFDA on-site inspection in 2H 2020

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5 3
2 2
Data as of 2020/06/30
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Data as of 2020/06/30

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Optimize Existing Generic API Portfolio

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40 37
Pipeline
35 Approved
30
20
25
20
12
15
10 17 7 6 6
5 4 2 3 2 2 2 2 1
5 2 4 3 2 1 2 2
1 1
0
Data as of 2020/06/30
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Expand CDMO Business

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12
12
10
8 6 8
7
8
1
SciAnda (Changshu)
4
6
ScinoPharm Taiwan
4
7 7
6
4
2
0
Phase 1 Phase 2 Phase 3 Commercial
Data as of 2020/06/30
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2020 Product Approval Plan

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2020 Product Approval Plan (I)

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Type Product Region Indication Brand
Marketer
Generic API Capecitabine CN( ) Various cancers Roche
Generic API Dantrolene
Sodium
CN( ) Skeletal Muscle
Relaxant
Par Sterile
Products
Generic API Tamsulosin HCl CN( ) Benign prostatic
hyperplasia (BPH)
Sanofi Aventis
()Generic API Irinotecan HCl CN( ) Colorectal cancer Pfizer
Generic API Fondaparinux
Sodium
CN Anti-thrombotic Mylan
Generic API Anastrozole CN Breast cancer ANI
Pharmaceuticals
Generic API Sodium
Phenylbutyrate
CN Urea cycle disorders Horizon
Therapeutics
Generic API Azilsartan CN Hypertension Arbor
Pharmaceuticals

:Approved

*: Added due to earlier than expected approval obtained Data as of 2020/06/30

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2020 Product Approval Plan (II)

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Type Product Region Indication Brand
Marketer
Generic API Galantamine HBr JP( ) Alzheimer’s disease Janssen
Generic API Topiramate JP Anti-convulsant Janssen
Generic API Topiramate EU Weight management Vivus
(**)Generic API Pemetrexed
Disodium 7H2O CEP
EU Non-small cell lung cancer Eli Lilly
Generic API Fulvestrant US Breast cancer AstraZeneca
CDMO API Donafenib CN Cancer Suzhou Zelgen
CDMO API Quofenix EU( ) Anti-biotic Menarini

:Approved

**: Collaborative project with partner for drug product development

Data as of 2020/06/30

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Operating Results

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Consolidated Income Statement

In NTD Million,
except for EPS
1H 2020
(Reviewed)
1H 2020
(Reviewed)
YoY 1H 2019
(Reviewed)
1H 2019
(Reviewed)
Revenue 1,451 100% 4% 1,390 100%
Gross Profit 682 47% 13% 604 44%
Operating Profit 252 17% 41% 179 13%
Net Profit before Tax 252 17% 51% 167 12%
Net Profit after Tax 197 14% 46% 136 10%
EPS (NTD) 0.25 - - 0.17 -

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1H 2020 Sales Distribution

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Drug
CDMO China Others
Product
India
18% 2% 7%
1%
15%
US+Canada
23%
Generic Japan
API 17%
EU
81%
36%
Others
CNS
by Business 6% by Region
23%
Oncology
71%
by Indication
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Sales Distribution – YoY

**Sales Distribution – YoY ** **Sales Distribution – YoY ** **Sales Distribution – YoY ** **Sales Distribution – YoY **
By Business
Unit: USD
Generic API CDMO Drug Product
1H 2020 Sales 39.1M 8.7M 0.5M
YoY 11.6% -3.0% -36.2%
By Indication By Indication By Indication By Indication
Oncology CNS Others
1H 2020 Sales 34.4M 10.8M 3.1M
YoY 13.3% 36.9% -53.1%
By Region By Region By Region By Region By Region By Region By Region
EU US &
Canada
Japan India China Others
1H 2020 Sales 17.4M 11.2M 8.1M 7.4M 0.9M 3.3M
YoY 6.6% 20.1% -6.2% 30.5% -8.9% -14.4%

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Consolidated Balance Sheet

In NTD Million 2020/6/30
(Reviewed)
2020/6/30
(Reviewed)
2019/6/30
(Reviewed)
2019/6/30
(Reviewed)
Cash and Cash Equivalents 3,803 31% 4,534 33%
Accounts Receivable 554 5% 434 3%
Inventories 1,299 11% 1,294 10%
Property, Plant & Equipment 4,255 35% 4,597 34%
Other Current/Non-Current Assets 2,197 18% 2,742 20%
Total Assets 12,108 100% 13,601 100%
Financial Debt 261 2% 1,368 10%
Other Current Liabilities 830 7% 863 6%
Other Non-Current Liabilities 636 5% 949 7%
Total Liabilities 1,727 14% 3,180 23%
Total Shareholders' Equities 10,381 86% 10,421 77%

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Consolidated Cash Flow Statement

In NTD million 1H 2020
(Reviewed)
1H 2019
(Reviewed)
From Operating Activities 368 444
From Investing Activities 123 (54)
From Financing Activities 29 (68)
Effect of foreign exchange rate changes (22) 9
Net Change in Cash 498 331
Beginning Balance 3,305 4,203
Ending Balance 3,803 4,534

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Q & A

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Brand Quality with Asian Advantages

www.scinopharm.com

1789 TT

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