SPT — Interim / Quarterly Report 2018

Jan 9, 2019

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1789 TT

ScinoPharm

2019/01/10

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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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Confidential

Table of Content

 Overview

 Strategies  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 (805 DMFs WW) with 31 of them oncology APIs

• 100+ contract projects with 6 launched (4 NCEs) and 7 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

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World Class Facilities

Taiwan

China

 API Plant

 API Plant

• 3 of 7 production lines equipped with high potency capabilities for cytotoxic

• 6 of 16 production lines equipped with high potency capabilities for cytotoxic/steroid

• Provides comprehensive CRAM services for brand drug companies

• US FDA approved cGMP facility for intermediates & high potency API

 Injectable Plant

• Strong R&D capabilities of APIs on small to large scales for generic & CRAM markets

• Vial and cartridge production lines for oncological and peptide products

• Strategic partnerships with China clients for formulations targeting global/China markets

• To meet US, EU, Japan GMP standards by adopting state-of-the-art isolator technology and single use technology for product contact path

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Confidential

2018 Sales Distribution

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

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Value Up

Value

Auto-injectors

Injectable & Solid Peptides Powder & Liquid Injectables

API

Tech Requirement

via In-House & CDMO APIs & Drug Products

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Strategies

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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
5 7 2 4 2 3 1
4 2 1 1 3 4
0
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Note: Others (Women's Health, Respiratory, Gastrointestinal, Immunology and Metabolic)
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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 or high unit-pricing

• Develop dossiers based on API expertise, including ANDA filing

• Apply ANDA with in-house APIs via P4 or 505(b)(2) fast track

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

• Fondaparinux Sodium)

• Submission of 1st in-house ANDA in late 2019

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

• Offer CMO services for proprietary and generic drugs

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Confidential

In-House Injectable Portfolio

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Vial
3 6
2 2
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Confidential

Strategy - Expand CDMO Business

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9
7
8
3
6
7
5 1
6
5 SciAnda (Changshu)
ScinoPharm Taiwan
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6 6 6
3
4
2
1
0
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Phase 1
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Phase 2

Phase 3 Commercial

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Confidential

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 capabilities of injectables

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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Operating Results

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P&L - Consolidated

		3Q 2018				3Q 2017					FY 2017
In NT$ million, except for EPS		(Reviewed)				(Reviewed)			YoY		(Audited)
Revenue		2,665	100%			2,621	100%		1.6% -10.6%		3,516	100%
Cost of Goods Sold		(1,568)	-59%			(1,418)	-54%				(1,966)	-56%
Gross Profit		1,097	41%			1,203	46%		-8.8% 6.9%		1,550	44%
OperatingExpense		(693)	-26%			(744)	-29%				(991)	-28%
Operating Income		404	15%			459	17%		-12.0% 24.3%		559	16%
Non-operatingIncome,Net		(46)	-2%			(61)	-2%				(84)	-2%
Income before Tax		358	13%			398	15%		-10.1%		475	14%
Net Income		349	13%			362	14%		-3.4%		422	12%
		0.44				0.46					0.53
EPS (NT$)
EBITDA		728	27%			782	30%		-7%		986 28%
* Totaloutstanding shareswere790.739munits at 09/30/2018.

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Balance Sheet- Consolidated

					3,950 31% - 0% 470 4% 1,830 14% - 0% 391 3% 5,122 40% 1,107 8% 12,870 100% 1,219 10% 1,300 10% 2,519 20% 10,351 80% 57.9 486.7 5.4 3.5 2017/09/30 (Reviewed)	3,950 31% - 0% 470 4% 1,830 14% - 0% 391 3% 5,122 40% 1,107 8% 12,870 100% 1,219 10% 1,300 10% 2,519 20% 10,351 80% 57.9 486.7 5.4 3.5 2017/09/30 (Reviewed)
(In NT$ million)		2018/09/30 (Reviewed)			2017/09/30 (Reviewed)
	Cash and Cash Equivalents	3,978 333 534 1,435 611 - 4,840 1,076	31%		3,950 - 470 1,830 - 391 5,122 1,107	31%
	Financial asset measured at amortised cost		3% 4% 11% 5% 0% 38% 8%			0% 4% 14% 0% 3% 40% 8%
	Accounts Receivable
	Inventories
	Financial asset measured at fair value through other comprehensive income
	Financial assets carried at cost
	Property, Plant & Equipment
	Other Current/Non-Current Assets
Total Assets		12,807	100%		12,870	100%
	Current Liabilities	2,145 71	17% 0%		1,219 1,300	10% 10%
	Long-Term & Other Liabilities
Total Liabilities		2,216	17%		2,519	20%
Total Shareholders' Equities		10,591	83%		10,351	80%
Key Indices A/R Turnover (Days) Inventory Turnover (Days) Current Ratio (x) ROE (%)		56.6 388.3 3.0 3.3			57.9 486.7 5.4 3.5
	A/R Turnover (Days) Inventory Turnover (Days) Current Ratio (x) ROE (%)

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Cash Flows- Consolidated

					789 398 329 62 (415) 0 (382) (110) (405) 543 (228) 243 3,707 3,950 407 (Reviewed) 3Q 2017	789 398 329 62 (415) 0 (382) (110) (405) 543 (228) 243 3,707 3,950 407 (Reviewed) 3Q 2017
(In NT$ million)		(Reviewed) 3Q 2018			(Reviewed) 3Q 2017
From Operating Activities		876			789
	Profit before tax	358 309 209			398 329 62
	Depreciation & Amortization
	Net change in workingcapital and others
From Investing Activities		(424)			(415)
	Financial asset measured at amortised cost	(333) (94)			0 (382)
	Capital expenditure
From Financing Activities		(365)			(110)
	Short-term loans	(10) 25 (380) 67			(405) 543 (228) 243
	Long-term loans
	Cash Dividends
Net Change in Cash
Beginning Balance		3,911			3,707
Ending Balance		3,978			3,950
Free Cash Flow		782			407

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Confidential

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Brand Quality with Asian Advantages

www.scinopharm.com

1789 TT

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