SPT — Annual Report 2018

Apr 1, 2019

1789 TT

ScinoPharm

April 01, 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 Strategies

 2019 Product Approval Plan

 Operating Results

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Overview

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ScinoPharm at a Glance

 Est. in 1997 and HQ in Taiwan (Tainan) with cGMP plants/R&D in Taiwan and China (Changshu) and marketing forces in Taiwan and China (Shanghai)

• Specializing in high potency (steroid/cytotoxic) APIs and injectable formulation, serving customers worldwide

• **70 generic APIs in portfolio with 29 APIs approved ***

• 60 active US DMFs (812 DMFs WW) with 31 of them oncology APIs

• **100+ contract projects with 6 launched (4 NCEs) and 8 in phase 3 for NDA 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

*** As of 2019/03/31**

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Key Updates

• 2018 consolidated sales were TWD 3.5 billion, up 0.2% yoy, with NPAT of TWD 443 million, up 4.9% yoy. EPS was TWD 0.56

• Team Strengthening

• Taiwan: CEO, ADM, R&D, QM and FIN

• China: GM and R&D

• Injectables Progress

 2 US ANDA approvals (Decitabine) in Mar 2018 and (Fondaparinux Sodium) in Nov 2018; 1 US ANDA submission in Sep 2018 under FDA review

• Inspection Result

• Changshu site successfully passed Japan PMDA inspection in May 2018

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Business Strategies

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Business Strategies

Optimize Existing Generic API Portfolio

Value up into Injectables

Expand CDMO Business

Actively Develop Japan and Emerging Markets

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Strategy - Optimize Existing Generics API Portfolio

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35
35 Approved
30 Pipeline
15
25
20
13
15
10 20 6 6 6 5
2 3
5 7 2 4 1
4 2 1 1 3 4
0

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*** Others include Women's Health, Respiratory, Gastrointestinal, Immunology and Metabolic Data as of 2019/03/31**

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Value Up

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Peptides
Oral Solids
Sterile Injectables
Extended Release
Oral Solids Auto Injectors
Immediate Release
APIs
Dermatological Otics & Opthalmics
Semi-Solids
Respiratory Devices
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Higher sustainable value
through greater entry barriers, and more tech, IP and regulatory requirements
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Strategy - Value Up into Injectables

 Leverage leading position in oncology APIs to expand formulation portfolio

• Target complex products with high entry barriers

• ANDA/Dossier development:

• Apply ANDAs with in-house APIs

• 3 US ANDA filings (via Injectable CMO) with 2 approvals

**(Decitabine and Fondaparinux Sodium) ***

• Submission of 1st ANDA using in house facility in late 2019

• **15 projects with multiple partners in China and US/EU ***

• Offer CMO services for proprietary and generic drugs

*** As of 2019/03/31**

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In-House Injectables Portfolio

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6 3
1 2
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Data as of 2019/03/31

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Strategy - Expand CDMO Business

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9
8 8
9
8
3 1
6
7
6
5
5 SciAnda (Changshu)
ScinoPharm Taiwan
4
7
6 6
3
2
3
1
0
Phase 1 Phase 2 Phase 3 Commercial
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Data as of 2019/03/31

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Strategy - Develop Japan 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 projects and leverage new injectable capabilities

China

• Focus on mid- to late-phase CRO projects

• Seek generic APIs/intermediates with large demand

South America & Russia

• Focus on market development

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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	US	Benign prostatic hyperplasia (BPH)	Boehringer Ingelheim
Generic API	Flumazenil	JP	Benzodiazepine antagonist	Genentech
Generic Drug		US	Antiemetic agent	Merck
New Drug	Intermediate for CRAM project	US, EU	Metabolic	CRAM Customer

Source: IQVIA Data (2017Q4-2018Q3)

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Operating Results

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Consolidated Income Statement

In TWD Million, except for EPS		2018 (Audited)		YoY		2017 (Audited)
Revenue		3,524	100%	0.2%		3,516	100%
Gross Profit		1,543	44%	-0.5%		1,550	44%
Operating Profit		558	16%	-0.1%		559	16%
Income before Tax		491	14%	3.2%		475	14%
Net Income		443	13%	4.9%		422	12%
EPS (NT$)		0.56	-	-		0.53	-

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2018 Sales Distribution

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BD &
CMO Others China Others
15% India 1% 5%
1%
10%
CRO JP
8%
19%
Generic US+Canada
API 42%
65%
EU
34%
Others
by Business 15%
Infectious by Region
15%
Oncology
56%
CNS
14%
by Indication
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Sales Distribution - YoY

**Sales Distribution - YoY **	**Sales Distribution - YoY **	**Sales Distribution - YoY **	**Sales Distribution - YoY **	**Sales Distribution - YoY **
By Business Unit: USD
	Generic API	CRO	CMO	BD & Others
2018 Sales	75.8M	22.4M*	17.2M*	1.6M
YoY	-5.6%	64.7%	10.4%	-75.4%

By Indication	By Indication	By Indication	By Indication	By Indication
	Oncology	Infectious	CNS	Others
2018 Sales	65.3M	17.9M	16.6M	17.2M
YoY	-14.2%	26.7%	44.3%	21.2%

By Region	By Region	By Region	By Region	By Region	By Region	By Region
	US & Canada	EU	India	Japan	China	Others
2018 Sales	49.2M	40.1M	11.6M	9.1M	0.8M	6.2M
YoY	4.0%	18.4%	-9.8%	-9.9%	-76.3%	-26.8%

*** Sales adjustment due to product reclassification between CRO & CMO**

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Consolidated Balance Sheet

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2018 2017
In TWD Million
(Audited) (Audited)
Cash and Cash Equivalents 4,203 34% 3,911 31%
Accounts Receivable 559 4% 567 4%
Inventories 1,364 11% 1,675 13%
Property, Plant & Equipment 4,759 38% 5,089 40%
Other Current/Non-Current Assets 1,678 13% 1,459 12%
Total Assets 12,563 100% 12,701 100%
Financial Debt 1,412 11% 1,692 13%
Other Current Liabilities 534 4% 521 4%
Other Non-Current Liabilities 78 1% 71 1%
Total Liabilities 2,024 16% 2,284 18%
Total Shareholders' Equities 10,539 84% 10,417 82%
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Financial Debt - to - Equity Ratio

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20.00%
17.27% 17.46%
16.24%
16.00%
13.62%
13.40%
12.00%
8.00%
4.00%
0.00%
2014 2015 2016 2017 2018
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Financial Debt - to - Equity Ratio = Total Financial Debt / Total Equity

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Consolidated Cash Flow Statement

In TWD million		2018 (Audited)		2017 (Audited)
From Operating Activities		1,231		972
From Investing Activities		(300)		(437)
Financial asset measured at amortized cost		(179)		0
Capital expenditure		(123)		(402)
From Financing Activities		(627)		(314)
Effect of foreign exchange rate changes		(12)		(17)
Net Change in Cash		292		204
Beginning Balance		3,911		3,707
Ending Balance		4,203		3,911

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Q & A

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Brand Quality with Asian Advantages

www.scinopharm.com

1789 TT

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