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SPT Interim / Quarterly Report 2018

Aug 2, 2018

51922_rns_2018-08-02_7979dca9-d431-4b78-8650-c4ccd736f67d.pdf

Interim / Quarterly Report

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1789 TT

ScinoPharm Taiwan, Ltd. H1 2018 On-Line Investor Meeting

August 2, 2018

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

Overall Updates of ScinoPharm

  • Business Updates

  • Financial & Operating Results in H1, 2018

3

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Overall Updates of ScinoPharm

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ScinoPharm at a Glance

  • ScinoPharm specializes in high potency (steroid/cytotoxic) APIs and injectable provider, serving customers worldwide

  • Facility & offices established in Taiwan and expanding in China with a new GMP plant in Changshu & marketing base in Shanghai

  • 71 generic APIs in current portfolio with 26 APIs launched; 57 US DMFs filed (776 DMFs WW), 34 US DMFs in oncology APIs. 100+ NCE CRAM projects, with 6 NDAs launched and 5 in phase III

  • Fully compliant with world-class cGMPs and international regulatory requirements; Certified by US FDA, EMA, EDQM, Australia TGA, Japan PMDA, Korea KFDA, Mexico COFEPRIS and Germany regulatory Authority

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Driving Long Term Growth by Dual Profits

  • Target difficult-to-make (peptide)API in our portfolio

  • Tap into drug product related to our API core competencies

  • Target 505(b)(2) and Paragraph IV drug product via strategic alliances

  • Provide CRO/CMO for APIs

  • Offer integrated service from API to formulation for niche injectables

  • Provide biologics fill & finish CMO services

6

Strong API Portfolio for Generic Product

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40 35 unlaunched
launched
35
30
25 22
20
13
15
10 7 7 6
13
5 6 2 2 2 3 3
6
4 1 2
3
2
1 1 1
0
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Note: Others (Women's Health, Respiratory and Immunology )

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Recap of Performances and Major Events

  • Reported the consolidated revenues for H1 2018 were NT$1.847 billion, net profits after-tax were NT$ 267 million, gross margin was 41%, EPS was NT$0.34

  • Financial performances were mainly benefited from the favorable sales volumes for colorectal cancer product of generics plus the increase of intermediates shipment for Phase III diabetes project

  • The 1st ANDA approved by US FDA, an oncological product and codeveloped with Sagent

  • Passed Japanese PMDA site inspections both in Taiwan and Changshu

  • Rated top 5% in the Corporate Governance Evaluation by TWSE

  • Issued 2017 corporate responsibility report verified by an independent third party

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Business Updates

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Strategic Alliance Highlights

* launched

Partner
Product

Indications

Region

Launch Year(E)

Remarks
Genovate Entecavir Hepatitis B Virus Taiwan 2013* 1st co-developed formulation product launch
Sagent Oncology
Injectable
Myeloid
Leukemia
US 2018* 1st US ANDA filing, triggering US FDA inspection
in Changshu, China site. Approved by US FDA in
March 2018
Foresee Leuprolide Prostate cancer US 2019 505(b)(2) NDA CRAM + Equity
Lee’s
Pharma
Fondaparinux Anti-thrombotic China 2022 Co-development collaboration
Travoprost
&Bimatoprost
Glaucoma China 2022
Nanjing
King Friend
Regadenoson Stress agent for
heart scan
China 2021 Co-developed formulation in China. Submitted
ANDA in October 2017
US partner Project A Non-small cell
lung cancer
US 2018 US NDA 505(b)(2) /Estimated launch year is
subject to litigation results
US & China
partners
Project B Imaging agent US 2021 ANDA with Paragraph IV filing / Estimated
launch year is subject to litigation results
Baxter 5 niche
injectables
Anti-cancer &
antinauseant
US/EU 2020&
continuing
thereafter
Baxter has the right to add up to 15 additional
injectable products for collaboration
Indian Int’l
partner
Fondaparinux Anti-thrombotic US/EU 2018 1st self-developed US ANDA submitted .
Executive right for marketing & sales

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CRO Phase III Products Portfolio

NDA Filing
Year (E)
Indication Region Remarks
2018 Type I
Diabetes
US/ EU Intermediate project made both in Changshu &
Taiwan. Type I anticipated launch in 2019.Type II
expected submission in 2019. Expected revenue
of several million USD per year after approval
2019 Type II
Diabetes
2018 Advanced Hepatocellular
Ci Mlfibi
CN API project made in Changshu site. CFDA
granted accelerated review under its category
arcnoma, yeoross,
Autoimmune disease
1.1 innovative drug. Anticipated launch in 2019
with demand in tons
2018 Prostate Cancer US / EU Started process validation. Anticipated launch in
2019 and revenue of several million USD per
year after approval
2019 Familial Adenomatous
Polysis
US / EU API project made both in Taiwan & Changshu
sites. Anticipated launch in 2020 with demand
in tons to tens tons after approval
2019 or 2020 Recurrent Anaplastic
Astrocytoma
US / EU Demand in tons after approval

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2018 CPhI China Observations

  • Fewer Western exhibitors in CPhI Trade Show this year

  • New drug flourishing as new guidelines make China a more drug-friendly market

  • As government is cracking down on noncompliance with environmental rules, API producers were buffeted by raw material and intermediate factory closures, suffered from supply chain disruption and volatility in chemicals pricing

  • New inspection regimen, tightened environment laws and high standard drug license approval process pushing out lowquality API suppliers

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Ranking API Product Indication
1 Paclitaxel Breast, Ovarian
and Lung Cancer
2 Irinotecan HCI Colorectal Cancer
3 Intermediates for CRAM project Diabetes
4 Gemcitabine Hydrochloride Pancreatic, Non-Small-Cell
Lung Cancer
5 Docetaxel Anhydrous Breast, Non-Small-Cell
Lung Cancer

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2018 Product Launch Plan

Type Product Region Indication Brand
Marketer
Regional
Sales
WW Sales
Generic API Tamsulosin
HCl
CN Benign Prostatic
Hyperplasia (BPH)
Boehringer
Ingelheim
US$97MM US$1,731m
Generic API Flumazenil JP Reversal of Conscious
Sedation and General
Anesthesia
Roche US$13.5MM US$78.4m
Generic API Capecitabine JP Antineoplastic Roche US$122MM US$797.4m
Generic
Drug
Oncology
Injectable
US Myeloid
Leukemia
MDS US$172.2m US$305m
Generic
Drug
Fondaparinux US Anti-thrombotic Mylan US$69.6m US$191.2m

Launched

Source: IMS Data 2017

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Financial & Operating Results H1, 2018

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Quarterly P&L - Consolidated

In NT$ million, except for EPS Q2 2018
(Reviewed)
Q1 2018
(Reviewed)
QoQ Q2 2017
(Reviewed)
YoY
Revenue 986 100% 861 100% 14%
-7%
853 100% 16%
-7%
Cost of Goods Sold (565) -57% (527) -61% (527) -62%
Gross Profit 421 43% 335 39% 26%
-22%
326 38% 29%
-9%
Operating Expense (261) -26% (213) -25% (239) -28%
Operating Income 160 16% 121 14% 32%
94%
86 10% 85%
74%
Non-operating Income, Net (2) 0% (31) -3% (7) -1%
Income before Tax 158 16% 90 11% 75% 79 9% 100%
Net Income 131 13% 136 16% -3% 84 10% 55%
EPS (NT$) 0.17 0.17 0.11

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Profit & Loss - Consolidated

(note)
4%
-12%
-5%
3%
-9%
YoY
In NT$ million, except for EPS H1 2018
(Reviewed)
H1 2017
(Reviewed)
YoY
Revenue 1,847 100% 1,773 100% 4%
-12%
Cost of Goods Sold (1,092) -59% (977) -55%
Gross Profit 755 41% 796 45% -5%
3%
Operating Expense (474) -26% (488) -28%
Operating Income 281 15% 308 17% -9%
Non-operating Income, Net (33) -2% (36) -2% 9%
Income before Tax 248 13% 272 15% -9%
Net Income 267 14% 255 14% 5%
EPS (NT$) 0.34 0.32
EBITDA 498 27% 523 29% -5%

Note: 2018H1 vs 2017H1: 3.2% NTD appreciation against USD YoY

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Sales by Business

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2018 H1
BD&
CMO Other
2017 H1
15% 1%
BD& CRO
Other 5%
CMO
8%
Generics
8%
CRO 79%
8%
Generics
76%
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Sales by Indications

2018 H1

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Others
Infectious
CNS
17%
3%
2017 H1 10%
Others
20%
Oncology
CNS
70%
12%
Oncology
68%
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Sales by Region

2018 H1

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CN ROW
JP
2017 H1
1% 6%
8%
India
CN ROW 10%
JP
2% 11% US+CAN
7%
36%
India EU
6% 39%
US+CAN
39%
EU
35%
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Balance Sheet- Consolidated

(In NT$ million) 2018/06/30
(Reviewed)
2017/06/30
(Reviewed)
Cash and Cash Equivalents 4,017
275
709
1,517
-
4,957
1,174
606
30% 3,721
-
726
1,802
391
5,136
1,105
-
29%

Financial asset measured at amortised cost
2%
5%
11%
0%
37%
10%
5%
0%
6%
14%
3%
40%
8%
0%
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 13,255 100% 12,881 100%
Current Liabilities 2,654
71
20%
1%
1,365
1,284
11%
10%
Long-Term & Other Liabilities
Total Liabilities 2,725 21% 2,649 21%
Total Shareholders' Equities
Key Indices
A/R Turnover (Days)
Inventory Turnover (Days)
Current Ratio (x)
ROE(%)
10,530 79% 10,232 79%
63.1
372.4
2.6
2.6
70.2
456.3
4.8
2.5
A/R Turnover (Days)
Inventory Turnover (Days)
Current Ratio (x)
ROE(%)

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Cash Flows- Consolidated

(In NT$ million) H1 2018
(Reviewed)
H1 2017
(Reviewed)
From Operating Actavities 370 353
Profit before tax 248
208
(86)
272
221
(140)
Depreciation & Amortisation
Net change in working capital
From Investing Actavities (350) (351)
Financial asset measured at (275) -
amortised cost
Capital expenditure (67) (321)
From Financing Actavities 76 43
Short-term loans 65
11
106
(477)
540
14
Long-term loans
Net Change in Cash
Beginning Balance 3,911 3,707
Ending Balance 4,017 3,721
Free Cash Flow 303 32

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Brand Quality with Asian Advantages

www.scinopharm.com

1789 TT

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