SPT — Annual Report 2019

Mar 31, 2020

1789 TT

ScinoPharm

March 31, 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

 Overview

 Business Outlook

 2020 Product Approval Plan

 Operating Results

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Overview

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ScinoPharm at a Glance

• Est. in 1997 in Taiwan (Tainan) with cGMP plants/R&D in Tainan and Changshu and marketing forces in Tainan, Shanghai and Tokyo

• Specializes in high potency (cytotoxic/steroid) API and injectable R&D and manufacturing with customers worldwide

• 73 generic APIs in portfolio with 31 referred and approved by ANDA/NDA*

• 62 active US DMFs (833 DMFs WW) with 37 oncology APIs

• 150+ contract projects with 7 approved/launched (5 NCEs) and 8 in phase 3 for NDA/MAA filing in 1-3 years*

 Certified by key international regulators - US FDA, EMA, EDQM, Australian TGA, Japanese PMDA, Korea KFDA, Mexico COFEPRIS and German Authority

*** Data as of 2020/02/29**

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2019 Achievements (I)

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 Tainan site passed the US FDA’s 7th inspection in May 2019, without 483

 2019 Approved Products

Type	Product	Region	Indication	Brand Marketer
Generic API	Docetaxel Trihydrate	US	Various cancers	Sanofi Aventis
Generic API	Tamsulosin HCl	US	Benign prostatic hyperplasia(BPH)	Sanofi Aventis
Generic API	Flumazenil	JP	Benzodiazepine antagonist	Genentech
Generic Drug	Fosaprepitant	US	Antiemetic agent	Merck
CDMO API	Intermediate for a NCE	EU	Metabolism	CRAM Customer

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2019 Achievements (II)

• Japan Market Expansion

• Capecitabine launched in January, 2019

• Flumazenil approved in November, 2019

• Injectable Business Progress

• Fosaprepitant approved by US FDA in September, 2019 and launched in November, 2019

• Fondaparinux Sodium PFS shipped to USA in November, 2019

• Exhibit batches of the first in-house product in prefilled syringe format completed

• Site Acceptance Test (SAT) of vial line completed

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Business Outlook

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

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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2020 Injectables Targets

• Fondaparinux Sodium PFS launched in USA in February, 2020

• Twelve products under development with target to complete registration batches for five products in 2020

• Aim to trigger TFDA on-site inspection

• Expect to submit the 1st in-house produced ANDA

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In-House Injectables Portfolio

 Twelve products under development with target to complete registration batches for five products in 2020

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5 3
2 2
Data as of 2020/02/29
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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 2020/02/29
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Expand CDMO Business

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12
10
8
7 6 7
8
1
SciAnda (Changshu)
2
6
ScinoPharm Taiwan
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7 7
5 5
2
0
Phase 1 Phase 2 Phase 3 Commercial
Data as of 2020/02/29
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Actively Develop Japan, China and Emerging Markets

• Japan

• 20 generic customers with 7 from top 10 drug firms

• Direct business with local generic customers

• Support Japanese and foreign pharmaceutical companies for market expansion

• Develop CRAM business and leverage new capabilities of injectables

• 15 approved JMF of Generic APIs

• China

• Expand new API business under MAH new regulation

• Develop API portfolio for China market

• Focus on FDA/CFDA Dual Filing Customers

• 20 Chinese customers with 8 targeting at Dual Filings

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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	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

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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	Anti-cancer	Suzhou Zelgen
CDMO API	Quofenix	EU( )	Anti-biotic	Melinta

：Approved

＊ ：Collaborative project with partner for drug product development

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Operating Results

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Consolidated Income Statement

In NTD Million, except for EPS	2019 (Audited)	2019 (Audited)	YoY	2018 (Audited)	2018 (Audited)
Revenue	2,893	100%	-18%	3,524	100%
Gross Profit	1,176	41%	-24%	1,543	44%
Operating Profit	267	9%	-52%	558	16%
Net Profit before Tax	265	9%	-46%	491	14%
Net Profit after Tax	217	8%	-51%	443	13%
EPS (NTD)	0.27	-	-	0.56	-

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2019 Sales Distribution

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BD & China
India Others
Others 4%
14% 12%
CDMO 10%
15%
US +
Canada
Generic EU
20%
API 30%
JP
75%
20%
Cardiovas Others
cular
8%
by Business 5% by Region
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5%
CNS
21%
Oncology
66%
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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	BD & Others
2019 Sales	70.4M	14.1M	9.2M
YoY	-6.5%	-64.3%	331.5%

By Indication	By Indication	By Indication	By Indication	By Indication
	Oncology	CNS	Cardiovascular	Others
2019 Sales	62.0M	19.4M	5.1M	7.2M
YoY	-5.1%	17.3%	77.3%	-77.7%

By Region	By Region	By Region	By Region	By Region	By Region	By Region
	EU	Japan	US & Canada	India	China	Others
2019 Sales	28.6M	18.8M	18.4M	12.7M	4.0M	11.2M
YoY	-28.7%	108.1%	-62.7%	9.1%	403.4%	80.6%

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Consolidated Balance Sheet

In NTD Million	2019 (Audited)	2019 (Audited)	2018 (Audited)	2018 (Audited)
Cash and Cash Equivalents	3,305	28%	4,203	34%
Accounts Receivable	590	5%	559	4%
Inventories	1,124	10%	1,364	11%
Property, Plant & Equipment	4,434	38%	4,759	38%
Other Current/Non-Current Assets	2,222	19%	1,678	13%
Total Assets	11,675	100%	12,563	100%
Financial Debt	234	2%	1,412	11%
Other Current Liabilities	508	4%	534	4%
Other Non-Current Liabilities	673	6%	78	1%
Total Liabilities	1,415	12%	2,024	16%
Total Shareholders' Equities	10,260	88%	10,539	84%

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Consolidated Cash Flow Statement

In NTD million	2019 (Audited)	2018 (Audited)
From Operating Activities	789	1,231
From Investing Activities	(98)	(300)
From Financing Activities	(1,572)	(627)
Effect of foreign exchange rate changes	(17)	(12)
Net Change in Cash	(898)	292
Beginning Balance	4,203	3,911
Ending Balance	3,305	4,203

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Q & A

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Brand Quality with Asian Advantages

www.scinopharm.com

1789 TT

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