SPT — Interim / Quarterly Report 2019

Aug 7, 2019

1789 TT

ScinoPharm

August 7, 2019

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

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 Overview

 Business Update

 2019 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

• 71 generic APIs in portfolio with 30 referred and approved by ANDA/NDA*

• 60 active US DMFs (813 DMFs WW) with 36 oncology APIs

• 100+ contract projects with 7 approved/launched (5 NCEs) and 7 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

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

  • Data as of 2019/06/30

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Business Update

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Existing Generics API Portfolio

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40 36 Pipeline
35 Approved
30
20
25
20
12
15
10 16 7 6 6
2 3
5 4 2 2 2 2
5 2 4 3 2 1 2 2
1
0
Others include Respiratory and Immunology Data as of 2019/06/30
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*** Others include Respiratory and Immunology**

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CDMO Business

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10
10
8
9
7 7
8
5
7
3 1
6
SciAnda (Changshu)
5
ScinoPharm Taiwan
4
7
6
3
5 5
2
1
0
Phase 1 Phase 2 Phase 3 Commercial
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Data as of 2019/06/30

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Injectables Status

• Injectables Business Progress

• Decitabine launched at end of September, 2018

• Fondaparinux Sodium expected to be launched in Q4, 2019

• The 3[rd] ANDA expected to be approved by US FDA in 2019

• In-house Facility status

• Vial Line : Line equipment tuning in progress

• Cartridge Line :

  • Exhibit batches of prefilled syringe producing in progress

  • Exhibit batches of Pen Device products expected to produce in Q4, 2019

• Working with marketing partners in US, EU, China and other territories via co-development or licensing model

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2019 Product Approval Plan

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2019 Product Approval Plan

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Type	Product	Region	Indication	Brand Marketer
Generic API	Bivalirudin	CN	Anticoagulant	The Medicines Company
Generic API	Docetaxel Trihydrate	US	Various cancers	Sanofi
Generic API	Fulvestrant	US	Breast cancer	AstraZeneca
Generic API	Tamsulosin HCl	US ( )	Benign prostatic hyperplasia (BPH)	Sanofi Aventis
Generic API	Flumazenil	JP ( )	Benzodiazepine antagonist	Genentech
Generic Drug		US	Antiemetic agent	Merck
New Drug	Intermediate for CRAM project	US EU ( )	Metabolism	CRAM Customer

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：Approved

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Operating Results

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Consolidated Income Statement

In NTD Million, except for EPS		1H 2019 (Reviewed)	1H 2019 (Reviewed)	YoY	1H 2018 (Reviewed)	1H 2018 (Reviewed)
Revenue		1,390	100%	-25%	1,847	100%
Gross Profit		604	43%	-20%	755	41%
Operating Profit		179	13%	-36%	281	15%
Net Profit before Tax		167	12%	-33%	248	13%
Net Profit after Tax		136	10%	-49%	267	14%
EPS (NTD)		0.17	-	-	0.34	-

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1H 2019 Sales Distribution

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CMO BD & India China
5% Others 2% 13% 2% Others
CRO JP
9%
15% 19%
US+Canada
Generic
21%
78% EU
36%
Others
Metabolic
5% by Region
by Business 10%
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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
1H 2019 Sales	35.1M	9.0M	0.8M
YoY	-28.7%	-28.1%	-0.1%

By Indication	By Indication	By Indication	By Indication	By Indication
	Oncology	CNS	Metabolism	Others
1H 2019 Sales	30.4M	7.9M	4.4M	2.2M
YoY	-31.0%	14.6%	-32.6%	-56.8%

By Region	By Region	By Region	By Region	By Region	By Region	By Region
	EU	US & Canada	Japan	India	China	Others
1H 2019 Sales	16.4M	9.3M	8.7M	5.6M	1.0M	3.9M
YoY	-33.8%	-58.8%	67.7%	-8.1%	119.8%	12.4%

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Consolidated Balance Sheet

In NTD Million	2019/6/30 (Reviewed)		2018/6/30 (Reviewed)
Cash and Cash Equivalents	4,534	33%	4,017	30%
Accounts Receivable	434	3%	709	5%
Inventories	1,294	10%	1,517	12%
Property, Plant & Equipment	4,597	34%	4,957	37%
Other Current/Non-Current Assets	2,742	20%	2,055	16%
Total Assets	13,601	100%	13,255	100%
Financial Debt	1,368	10%	1,779	13%
Other Current Liabilities	863	6%	874	7%
Other Non-Current Liabilities	949	7%	72	1%
Total Liabilities	3,180	23%	2,725	21%
Total Shareholders' Equities	10,421	77%	10,530	79%

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Consolidated Cash Flow Statement

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1H 2019 1H 2018
In NTD million
(Reviewed) (Reviewed)
From Operating Activities 444 370
From Investing Activities (54) (350)
Financial asset measured at amortized cost 0 (275)
Capital expenditure (48) (67)
From Financing Activities (68) 76
Effect of foreign exchange rate changes 9 10
Net Change in Cash 331 106
Beginning Balance 4,203 3,911
Ending Balance 4,534 4,017
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Q & A

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Brand Quality with Asian Advantages

www.scinopharm.com

1789 TT

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