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SPT — Investor Presentation 2016
Feb 18, 2016
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Investor Presentation
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TWSE 1789
ScinoPharm Management Presentation
Fourth Quarter 2015 Investor Conference
February 18, 2016
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 of ScinoPharm
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Financial & Operating Results in 4Q 2015
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Perspectives in Latin American Market
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Overview of ScinoPharm
- An API + ANDA Company
Active Pharmaceutical Ingredients Abbreviated New D A rug pplication
44
Confidential
Business Overview
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Established in 1997 in Taiwan, listed on TWSE in 2011, and honored as the top 5% TWSE issuer in info disclosure & corporate governance
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Specialized in high potency (cytotoxic/steroid) APIs and integrating to injectable formulations
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Facility built in Taiwan and expanding in China with a marketing base in Shanghai and a newly US FDA approved plant in Changshu
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80 generic APIs developed with 27 APIs launched; 55 US DMFs filed (734 DMFs WW), 29 US DMFs in oncology APIs. 100+ NCE CRAM projects, with 5 launched and 6 in phase III for NDA filing in 2-3 years
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Fully Complied with world-class cGMP and regulatory requirements; Certified by US FDA, EMA, Australian TGA, Japanese PMDA, Korean FDA, Mexican COFEPRIS, etc.
5
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
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:
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Vertical Integration to Generic Formulations Developing dossiers per our difficult-to-make APIs to increase value proposition in the supply chain
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:
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Innovative Delivery Formulations Targeted delivery & extended release of proven APIs via 505(b)2 fast track
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:
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Brand New Chemical Entities (New Drugs) Collaborating with academic research institutes, focusing on un-met oncology medical needs of high prevalence in Asia
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Keys to Generic Formulation Business
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Expanding formulation portfolio
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Building on-site injectable facility and forming a complete supply chain of drug products
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Promoting our formulations via strategic alliance, especially in China, US, & EU
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Acquiring critical resources via M&A
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Strong Generics Product Portfolio
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launched
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ScinoPharm - Oncology API Leader
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Stand-Alone API Company
ScinoPharm 29 26
Shilpa 12 9 2
Polymed 10 1 3
# Oncology DMF Overlap with SPT
MacChem Products 7 5 2
# Non-overlapping Oncology DMF
Laurus Labs 7 6 10 # Other DMFs
Sichuan Xieli 6 8 13
Chemwerth 3 5 30
Apicore 5 5 22
0 10 20 30 40 50 60
Big Generic Pharmaceutical Company
ScinoPharm 29 26
Teva 16 23 253
Dr. Reddy's 17 12 192
Cipla 10 16 124
Sun 16 11 167
Hisun 11 21 48 # Oncology DMF Overlap with SPT
# Non-overlapping Oncology DMF
Qilu 7 2 8
# Other DMFs
Hengrui 3 3 9
0 50 100 150 200 250 300
Source: US FDA (2015Q3) 9
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Strate ic Alliance Hi hli hts g g g
*** Launched already**
| Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch* |
|---|---|---|---|---|---|---|---|
| Partner | Product |
Indications |
Region |
Launch Year(E) |
Remarks |
||
| Genovate | Entecavir | Hepatitis B Viral | Taiwan | 2013* | 1st co-developed formulation product launch |
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| Sagent | Oncological Injectable |
Myeloid Leukemia |
US | 2016 | 1st US ANDA filing, triggered US FDA inspection in Changshu site |
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| Foresee | Leuprolide | Prostate cancer | US | 2018 | 505(b)2 NDA CRAM + Equity | ||
| Coland | Bortezomib | Multiple Myeloma |
China | 2019 | 1st co-developed drug in China to trigger CFDA inspection in Changshu site |
||
| Azacitidine | MDS | China | 2020 | Co-developed formulation | |||
| Lee’s Pharma |
Fondaparinux | Anti- thrombotic |
China | 2020 | Strategic alliance collaboration in formulation |
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| Travoprost Bimatoprost |
Glaucoma | China | 2022 | Strategic alliance collaboration in formulations |
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| Nanjing King Friend |
Regadenoson | Stress agent for heart scan |
China | 2020 | 1st type 3.1 co-developed new drug in China |
||
| 10 Already launched* US partner Project A non-small cell lung cancer US 2019 US NDA 505(b)2 & Paragraph IV filing US & Chinese partners Project B imaging agent US 2019 Paragraph IV filing** |
US partner | Project A | non-small cell lung cancer |
US | 2019 | US NDA 505(b)2 & Paragraph IV filing | |
| 10 Already lau* US & Chinese partners** |
nched Project B |
imaging agent | US | 2019 | Paragraph IV filing |
10
2016 API Product Launch Plan
| Product Name Region Indications Brand Marketer Regional Sales WW Sales |
Product Name Region Indications Brand Marketer Regional Sales WW Sales |
Product Name Region Indications Brand Marketer Regional Sales WW Sales |
Product Name Region Indications Brand Marketer Regional Sales WW Sales |
Product Name Region Indications Brand Marketer Regional Sales WW Sales |
Product Name Region Indications Brand Marketer Regional Sales WW Sales |
Product Name Region Indications Brand Marketer Regional Sales WW Sales |
Product Name Region Indications Brand Marketer Regional Sales WW Sales |
|---|---|---|---|---|---|---|---|
| Product Name | Region | Indications | Brand Marketer | Regional Sales | WW Sales | ||
| Azacitidine | USA | Myelodysplastic syndromes (MDS) |
Celgene | US$248.1M | US$751.6M | ||
| Desmopressin Acetate |
USA | Polyuria | Ferring | US$150.1M | US$395.8M | ||
| Entecavir | USA, Singapore, |
Hepatitis B Virus (HBV) |
Bristol-Myers | US$262.5M (USA only) |
US$1,576.6M | ||
| Australia | |||||||
| Flumazenil | Korea | Reversal of the sedative effects of benzodiazepines |
Roche | N/A | US$84.0M | ||
| Gemcitabine HCl |
Middle East |
Pancreas, Lung, Ovary, Breast Cancers. |
Eli Lilly | N/A | US$547.9M | ||
| Tamsulosin HCl USA Benign Prostatic Hyperplasia (BPH) Boehringer Ingelheim US$410.0M US$1,818.4M |
|||||||
| Tamsulosin HCl |
USA | Benign Prostatic Hyperplasia (BPH) |
Boehringer Ingelheim |
US$410.0M | US$1,818.4M |
Source: *IMS Data (2014Q4-2015Q3)
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Pipeline Outlook
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5-6 new launches
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4-6 new launches � 5-6 new launches
- 1[[st ]] home-made drug launched in US
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1[st] co-developed US � 1[st ] home-made drug US 1[[st ]] home-made drug launched in US ANDA launched ANDA filing � 3 drug products launched in China
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2016 2017 2018 2019 2020
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3-5 new launches � 6-8 new launches
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1[st] self-developed US ANDA launched
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Chinese CFDA inspection at SPC
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1 drug product launched in China
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US FDA inspection at INJ
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Financial & Operating Results
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Profit & Loss - Consolidated
| In NT$ million, except for EPS FY 2015 (Unaudited) FY 2014 (Audited) YoY |
In NT$ million, except for EPS FY 2015 (Unaudited) FY 2014 (Audited) YoY |
In NT$ million, except for EPS FY 2015 (Unaudited) FY 2014 (Audited) YoY |
In NT$ million, except for EPS FY 2015 (Unaudited) FY 2014 (Audited) YoY |
In NT$ million, except for EPS FY 2015 (Unaudited) FY 2014 (Audited) YoY |
In NT$ million, except for EPS FY 2015 (Unaudited) FY 2014 (Audited) YoY |
|---|---|---|---|---|---|
| In NT$ million, except for EPS | FY 2015 (Unaudited) |
FY 2014 (Audited) |
YoY | ||
| Operating Revenue | 3,955 | 4,098 | -3% | ||
| Gross Profit | 1,677 | 1,600 | 5% | ||
| Gross margin | 42% | 39% | |||
| Operating Expenses | (927) | (1,041) | -11% | ||
| Operating Income | 750 | 559 | 34% | ||
| Operating margin | 19% | 14% | |||
| Other Rev. (Exp.) | 53 | 43 | 23% | ||
| Net Income before Tax | 803 | 602 | 33% | ||
| Net Income after Tax 635 484 31% Net margin after tax 16% 12% EPS (after tax) 0.87 0.66 32% |
Net Income after Tax | 635 | 484 | 31% | |
| Net margin after tax | 16% | 12% | |||
| EPS (after tax) | 0.87 | 0.66 | 32% |
14
Balance Sheet- Consolidated
| In NT$ million | 2015/12/31 (Unaudited) |
2015/12/31 (Unaudited) |
2014/12/31 (Audited) |
2014/12/31 (Audited) |
||
|---|---|---|---|---|---|---|
| Cash and Cash Equivalents | 2,336 | 19% | 1,928 | 17% | ||
| Accounts Receivable | 867 | 7% | 523 | 5% | ||
| Inventories | 2,169 | 18% | 2,449 | 22% | ||
| Long-Term Investments | 339 | 3% | 248 | 2% | ||
| Property, Plant & Equipment | 5,171 | 42% | 5,065 | 44% | ||
| Other Current/Non-Current Assets | 1,340 | 11% | 1,159 | 10% | ||
| Total Assets | 12,222 | 100% | 11,372 | 100% | ||
| Current Liabilities 2,275 18% 1,918 17% Long-Term & Other Liabilities 90 1% 74 1% Stockholders’ Equities 9,857 81% 9,380 82% 15 |
Current Liabilities | 2,275 | 18% | 1,918 | 17% | |
| Long-Term & Other Liabilities | 90 | 1% | 74 | 1% | ||
| Stockholders’ Equities | 9,857 | 81% | 9,380 | 82% |
Cash Flows- Consolidated
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FY 2015 FY 2014
In NT$ million
(Unaudited) (Audited)
Cash and cash equivalents at
1,928 2,289
be innin of eriod
g g p
Cash flows from operating activities 1,045 888
CAPEX (657) (1,018)
Short-term borrowings 425 588
Cash Dividends (141) (811)
Others (264) (8)
Cash and cash equivalents at
2,336 1,928
end of eriod
p
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Sales by Business
FY2015
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BD
CRO
CMO
2%
5%
8%
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FY2014
CRO+BD
CMO
4%
Generics
20%
85%
Generics
76%
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Sales by Indications
FY2015
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CNS Others
17% 7%
FY2014
Oncology
Others
76%
11%
CNS Oncology
27% Oncology60%
62%
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Sales by Region
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Sales by Region FY2015
Rest of
ROW
AU/NZ
Asia
<1%
5%
12%
FY2014 India
US/CAN
18%
Rest of AU/NZ 42%
ROW EU
Asia 2%
<1%
23%
11%
India
15%
US/CAN
EU 42%
30%
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Perspectives in Latin American Market
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Pharmerging Markets
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IMS Health identified 21 countries as the “Pharmerging” markets per their macroeconomics and pharma market forecasts
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Tier 1: China -- accounts for half of Pharmerging market growth; Tier 2: Brazil, India, & Russia; Tier 3: Argentina, Colombia, Mexico, Poland, Turkey, Venezuela
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� Governments in Pharmerging markets promote generics to expand healthcare coverage cost effectively
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Branded generics are popular in Pharmerging markets as quality assurance
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Big Pharmas tap M&A for local expansion and market presence
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Opportunities in Latin America
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The main consumers aged 20-50 account for 44% of 600Mn people. Latin America as a key growth region of 14% CAGR in 2008 thru 2012 and expected to keep outgrowing after 2016
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Governments encourage generic drugs, manage drug pricing affordable in the domestic market, and elevate generic drug penetration rate to 30% – 50%
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A high level of imported drugs pushes local governments to support domestic firms via favorable policies
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Argentina, Brazil, and Colombia upgrading into regulated markets and cultivating regional trading via continual GMP regulatory tightening and harmonization
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Latin American Markets Fuel the Growth
Share of pharmaceutical spending by region 2013-2017
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38% 35%
Source: Americas Market Intelligence
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Product Mix Fits Key Needs in Americas
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Source: WHO; PWC strategy & analysis
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Market Size
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Colombia
US$2.9Bn
Venezuela
US$10.2Bn
Mexico
US$12.4Bn
Brazil
US$31.4Bn
Chile
Others Argentina
US$2.1Bn
US$8Bn
US$6.6Bn
Source: Sales in 2012, Americas Market Intelligence
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Major Latin American Landscape
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Brazil keeps lifting its healthcare expenditure, accounting for Latin American pharma sales of 45% and expected to become the global 5[th] largest pharm market soon
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Mexico, as the region’s 2[nd] largest market, bridges the well-established and emerging markets in Americas. Mexico’s expansion in healthcare coverage triggers the demand for generic drugs, with 70% penetration
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Argentina actively promotes its pharmaceutical industry, which exports finished and semi-finished drugs to over 115 countries, mainly to the US, EU and Brazil
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Growing Customer Base in Latin America
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ScinoPharm reaching out new business along with big pharma customers’ M&As, cultivating over 10 domestic customers by 2015
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Sales in Latin America has grown 90% in 2015 from 2014 and is expecting a significant growth continuously
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Both Tainan and Changshu sites passed GMP inspection by Mexican regulatory agency COFEPRIS
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Aim to be a vital API supplier to the high-end oncology generic and brand name drugs in Latin America
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uestions Q
&
Answers
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Brand Quality with Asian Advantages www.scinopharm.com
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