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SPT Investor Presentation 2015

Feb 3, 2015

51922_rns_2015-02-03_7b968e2c-d5dc-4617-bbfb-899b50909ee0.pdf

Investor Presentation

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ScinoPharm Management Presentation

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TWSE 1789

February 3, 2015

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 of ScinoPharm

Financial & Operating Results in Q4, 2014

Progress Made in China

Business Updates

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Overview of ScinoPharm

- An API + ANDA Company

Active Pharmaceutical Ingredients Abbreviated New D A rug pplication

3 4

Confidential

Business Overview

  • Established in 1997 in Taiwan and listed on TWSE in 2011, current market cap around US$1.2 billion

  • Specializes in high potency (steroid/cytotoxic) APIs and expands to injectable formulations

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

  • 70 generic APIs developed with 27 APIs launched; 50 US DMFs filed (694 DMFs WW), 24 US DMFs in oncological APIs

80+ NCE CRAM projects, with 5 launched and 9 in phase III for NDA filing in 2-3 years; The Qualified Asian supplier to provide APIs to global market for multiple commercial NCEs

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Strong Generics Product Portfolio

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ScinoPharm - Oncological API Leader

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Diversified CRAM Portfolio

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Stage MFG Site First Launch Year Indication Location
Commercial SPT 2005 Eluting Stent US
Commercial SPT 2009/2013 Skin Infection/HAP US/EU
Commercial SPT 2011 Depression US
Commercial SPT 2012 Obesity US
**Commercial ** SPT 2013 Seizure US
Stage MFG Site Est. NDA Filing Year Indication Location
Phase III SPT 2014* Infections US
Phase III SPT 2016 Prostate & Ovarian Cancer EU
Phase III SPT 2016 Prostate Cancer US
Phase III SPT 2017 Seizure US
Phase III SPT 2017 Parkinson’s Disease US
Phase III SPT 2017 Opioid-Induced Constipation US
Phase III SPC 2016-2017 Ovarian Cancer CN
Phase III SPC 2016 Hypogonadism US
Phase III SPC 2017 Cancer CN

*** Filed**

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Long Term Strategies

Transforming to a full-scope pharma company per our core competency of R&D and cGMP manufacturing in high-technical barrier APIs

  • Vertical Integration to Generic Formulations: Developing dossiers per our difficult-to-make APIs to increase value proposition in the supply chain

  • Innovative Delivery Formulations: Targeted delivery & extended release of proven APIs via 505(b)2 fast track

  • Brand New Chemical Entities (New Drugs): Collaborating with academic research institutes, focusing on un-met oncological medical needs of high prevalence in Asia

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Keys to Generic Formulation Business

  • Expanding formulation portfolio

  • Building on-site oncological injectable facility and establishing a complete supply chain of oral products

  • Promoting our formulations via strategic alliance, especially in China and US

  • Acquiring critical resources via M&A

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Strategic Alliances

*** Already launched**

Partner Product Indications Region Launch
Year(E)
Remarks
Genovate Entecavir Hepatitis B Viral TW*/
CN
2013*/
2019
1st co-developed formulation
product launch
Sagent Oncological
Injectable
Myeloid
Leukemia
US 2017 1st US ANDA filing to trigger US
FDA inspection in Changshu
site
Foresee Leuprolide Prostate cancer US 2018 505(b)2 NDA CRAM + Equity
Coland Bortezomib Multiple
Myeloma
CN 2018 1st co-developed drug in China
to trigger CFDA inspection in
Changshu
Azacitidine MDS CN 2019 Co-developed formulation
Lee’s
Pharma
Fondaparinux Anti-thrombotic CN 2019 Co-developed formulation
Travoprost
Bimatoprost
Glaucoma CN 2020 Co-developed formulation
Nanjing
King
Friend
Regadenoson Stress agent for
heart scan
CN 2020 1st type 3.1 co-developed new
drug in China

Pipeline Outlook

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 4-5 new launches  8-10 new launches  6-8 new launches
 US FDA inspection on SPC  1 [st] co-developed drug  1 [st] type 3.1 co-developed
product launched in China new drug launched in
China
 US FDA inspection on INJ
2015 2016 2017 2018 2019 2020
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 4-5 new launches  5-6 new launches  7-9 new launches
 1 [st ] CRAM service of
 1 [st] ANDA product
type 1.1 new drug
launched in US
launched in China
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Financial & Operating Results

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Cumulative P&L - Consolidated

In NT$ million, except for EPS 1Q~4Q,’14
(Unaudited)
1Q~4Q,’13
(Audited)
YoY
Net Sales 4,098 5,088 -19%
Gross Profit 1,600 2,543 -37%
Gross margin 39% 50%
Operating Expenses (1,041) (1,145) -9%
Operating Income 559 1,398 -60%
Operating margin 14% 27%
Other Rev.(Exp.) 43 11 291%
Net Income before Tax 602 1,409 -57%
Net Income after Tax 484 1,273 -62%
Net margin after tax 12% 25%
EPS (after tax) 0.69 1.81 -62%

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Balance Sheet- Consolidated

In NT$ million 2014/12/31
(Unaudited)
2014/12/31
(Unaudited)
2013/12/31
(Audited)
2013/12/31
(Audited)
Cash and Cash Equivalents 1,928 17% 2,289 20%
Accounts Receivable 523 5% 971 8%
Inventories 2,449 22% 2,512 22%
Long-Term Investments 248 2% 258 2%
Property, plant and equipment 5,065 44% 4,214 37%
Others 1,159 10% 1,240 11%
Total Assets 11,372 100% 11,484 100%
Current Liabilities 1,918 17% 1,775 15%
L-T Liabilities and Others 74 1% 66 1%
Stockholders’ Equities 9,380 82% 9,643 84%

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Cash Flows- Consolidated

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1Q~4Q 2014 1Q~4Q 2014
In NT$ million
(Unaudited) (Audited)
Cash and cash equivalents at
2,289 3,035
beginning of period
Cash flows from operating activities 888 939
CAPEX (1,018) (1,226)
Long-term Investment 0 (107)
Short-term borrowings 588 426
Cash Dividends (811) (780)
Others (8) 2
Cash and cash equivalents at
1,928 2,289
end of period
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Sales by Business

FY2014

CRO+BD

<1%

FY2013

CRO < 1%

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CMO
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Sales by Indications

FY2014

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Others
11%
FY2013
CNS
Others
Oncology
27%
4%
62%
CNS
Oncology
39%
57%
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Sales by Region

FY2014

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Rest of
AU&NZ
Asia ROW
2%
11% <1%
India
15%
US&CAN
EU
42%
30%
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FY2013

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India
15%
AU&NZ ROW
Rest of 5% <1%
Asia
12%
India
US&CAN
12%
52%
EU
19%
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Progress Made in China

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Confidential

Golden Opportunities in China

  • Government’s 12[th] five-year plan encourages pharma industry to grow at a CAGR of 20%

  • Tighten GMP requirements to align with US/EU

  • Motivate drug makers to improve quality by applying for US ANDAs, which need SPT’s world class APIs

  • MNCs and emerging virtual-model players create huge needs in API contract manufacturing in China for compliance

  • ScinoPharm timely captures oncological API needs via importing from Taiwan and local made in Changshu sites

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Portfolio Fits China’s Demands

Rank Therapeutic
indication
2012 China
Market Share
# of SP’s API
candidates
1 Anti-cancer 18.9% 31
2 Anti infective 15.3% 5
3 Cardiovascular 14.5% 7
4 Metabolic 14.1% 5
5 Blood & Blood-Forming 11.8% 0
6 CNS 10.9% 9

Source: Blue Book on 6 major drugs of Chinese pharmaceutical industry , 2013

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Confidential

Provide 6 of Top 10 Oncological Drugs

Rank Drug 2012
Sales*
% of
market
% of growth SP’s Pipeline
1 Paclitaxel 1144 9.15% 19.01% V
2 Docetaxel 1049 8.39% 7.81% V
3 Pemetrexed 688 5.50% 44.32% V
4 Oxaliplatin 662 5.30% 5.51%
5 Kangai 570 4.56% 31.94%
6 Capecitabine 568 4.54% 15.45% V
7 Rituximab 535 4.28% 18.69%
8 Gemcitabine 454 3.69% 6.51% V
9 Tegafur 446 3.57% 87.77% V
10 Herceptin 387 3.09% 17.31%

*** Unit: RMB Million Source: Analysis Report of Anti-Cancer Drugs, 2014**

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Confidential

Key Progress for China Market

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ScinoPharm
Taiwan
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Submitted drug import license applications for 10 APIs (5 for anti-cancer, 2 for cardiovascular, 1 for Alzheimer's disease, 1 for benign prostatic hyperplasia and 1 for Hepatitis B )

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ScinoPharm
Changshu
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• Obtained drug production permits for 9 APIs (6 for anti-cancer, 1 for anti-viral and 2 for glaucoma ) • Submitted 2 drug license applications for anticancer APIs

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Strategic
Alliance
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5 formulation development and 1 new drug projects smoothly undergoing. Expected to be commercially available in 2018-2020

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Business Updates

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Injectable Plant Progress

  • To be completed by Q2’15 and start registration batch production for liquid vial line by Q4’15. Expected to submit the 1[st] home-made ANDA in 2017 and pass US FDA inspection in 2018

  • Target on biologics, high potent new drugs and smallvolume, complicated and high unit-priced generics

  • Offer CMO services for brand drugs and self-developed drug products in the initial stage

  • Flexible in capacity expansion and capable for producing liquid/lyophilized vials and prefilled syringes

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2015 Product Launch Plan

API Region Indications Brand
Marketer
Regional Sales WW Sales
Azacitidine US MDS Oncology Celgene US$323MM* US$815MM*
Benazepril CN Hypertension,
CV
Novartis US$65MM** US$480MM*
Desmopressin
US
Polyuria Ferring US$131MM* US$395MM*
Letrozole JP Breast Cancer Novartis US$51MM** US$581MM*
Tamsulosin US Benign prostatic
hyperplasia
(BPH)
Boehringer
Ingelheim
US$335MM* US$1,829MM*
Source: * IMS Data (2013Q3-2014Q2) ** In-house research

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uestions Q

&

Answers

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Brand Quality with Asian Advantages www.scinopharm.com

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