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SPT — Investor Presentation 2016
Jun 13, 2016
51922_rns_2016-06-13_be680349-570b-4a79-bdd6-23fb986a5290.pdf
Investor Presentation
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TWSE 1789
ScinoPharm Management Presentation
2016/05/11
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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. Forwardlooking 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
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Overview of ScinoPharm
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ScinoPharm’s Strategies and Opportunities
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Operating Results & Outlook
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Overview of ScinoPharm
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Background
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Established in 1997 in Taiwan and listed on TWSE in 2011
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Major shareholders include Uni-President Group, National Development Fund, & Taiwan Sugar
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Facility & organization built in Taiwan by experienced Syntex team, received multiple regulatory inspections from US FDA, Australia, EU, Japan, etc.
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Specializes in high potent/cytotoxic APIs & moves to injectable formulations
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Expanding in China with a marketing base in Shanghai & new GMP plant in Changshu, just inspected by US FDA with zero 483
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World Class API Facilities
Taiwan
China
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6.6 hectares of land, 330K sqft facilities with >200M[3] reactor volume
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6.5 hectares of land with > 250M[3 ] reactor volume
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6 of 16 production lines equipped with high potency capabilities for cytotoxic/steroids
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Passed US FDA, EMA, Australian TGA, Japanese PMDA inspections & 300+ cGMP customer audits
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Provides comprehensive contract research & manufacturing services for brand drug companies
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Global Market
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3 of 7 production lines equipped with high potency capabilities for cytotoxics
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US FDA approved cGMP facility for intermediates & high potency API
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Full scope capabilities in developing and producing APIs from small to large scale for generic & CRAM markets
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Global market including China
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Confidential
Business Overview
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Risk & return balanced model to offer APIs and sterile filling capability for both generic and new drugs
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80+ generic APIs developed with 27 APIs launched; 56 US DMFs filed (738 DMFs WW), 29 US DMFs in oncology APIs
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100+ NCE CRAM projects, with 5 launched and 5 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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Confidential
2015 Sales Distribution
By Indication
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By Business
By Region
Generic
77%
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Confidential
Strong Generics Product Portfolio
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45 42
40
28
35
30
25
20
unlaunched
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3 launched
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10 7
1414 3 4 5
3 3
5 6 2 2 2 2 2
14 3
6 2 3
1 [2] 1 1 2 1 3 2 2 2
0 2
1 2 3 2 2
2
2 2 2 2
1 1
2
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Confidential
Diversified CRAM Portfolio
| Stage First Launch Year Indication Location |
Stage First Launch Year Indication Location |
Stage First Launch Year Indication Location |
Stage First Launch Year Indication Location |
Stage First Launch Year Indication Location |
Stage First Launch Year Indication Location |
|---|---|---|---|---|---|
| Stage | First Launch Year | Indication | Location | ||
| Commercial | 2005 | Eluting Stent | US | ||
| Commercial | 2009/2013 | Skin Infection/HAP | US/EU | ||
| Commercial | 2011 | Depression | US | ||
| Commercial | 2012 | Obesity | US | ||
| Commercial | 2013 | Seizure | US | ||
| Stage | Est. NDA Filing Year | Indication | Location | ||
| Phase III | 2016 | Infections | US / EU / Asia | ||
| Phase III | 2017 | Ovarian Cancer | US / EU | ||
| Phase III | 2017 | Prostate Cancer | US | ||
| Phase III 2017 Ovarian Cancer CN Phase III 2017 Parkinson’s Disease US |
Phase III | 2017 | Ovarian Cancer | CN | |
| Phase III | 2017 | Parkinson’s Disease | US |
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ScinoPharm’s Strategies and Opportunities
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Confidential
Long Term Strategies
core Transforming to a full-scope pharma company per our competency of R&D and cGMP manufacturing in hightechnical 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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� : Brand New Chemical Entities (New Drugs) Collaborating with start-ups & 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 oncology injectable facility and establishing a complete supply chain
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Sustaining B2B model, promoting our formulations via strategic alliance, especially in China and US/EU
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Acquiring critical resources via M&A
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Strategic Alliance Highlights
*** Already launched**
| 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 |
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| Genovate | Entecavir | Hepatitis B Viral | Taiwan | 2013* | 1st co-developed formulation product launch | ||
| Sagent | Oncology 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 |
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| Azacitidine | MDS | China | 2020 | Co-developed formulation | |||
| Lee’s Pharma |
Fondaparinux | Anti-thrombotic | China | 2020 | 1st self-developed drug in China | ||
| Travoprost Bimatoprost |
Glaucoma | China | 2022 | Co-developed formulations | |||
| Nanjing King Friend |
Regadenoson | Stress agent for heart scan |
China | 2020 | 1st type 3.1 co-developed new drug in China | ||
| US partner Project A non-small cell lung cancer US 2019 US NDA 505(b)2 & Paragraph IV filing US & China 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 | |
| US & China partners |
Project B | imaging agent | US | 2019 | Paragraph IV filing |
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Confidential
ScinoPharm - Oncology API Leader
Stand-Alone API Company
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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 33 9
Source: US FDA 2016 Q1
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DMF database 0 50 100 150 200 250 300
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Operating Results & Outlook
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Historical Performance
Unit: In NT$ million
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5,088
4,572
5,000
4,098
3,887 3,953 3,955
3,791
4,000
3,145
2,494
3,000
2,000 1,463
613 1,273 484
1,000 872 1,170
1,041 1,040
143 961
635
484
0
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
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Recent Financial
*** In NT$**
| Year 2013 2014 2015 |
Year 2013 2014 2015 |
Year 2013 2014 2015 |
Year 2013 2014 2015 |
Year 2013 2014 2015 |
Year 2013 2014 2015 |
|---|---|---|---|---|---|
| Year | 2013 | 2014 | 2015 | ||
| Total assets* | 11,484 M | 11,372 M | 12,222 M | ||
| Shareholders’ equity* | 9,643 M | 9,380 M | 9,857 M | ||
| Sales* | 5,088 M | 4,098 M | 3,955 M | ||
| Net profit after tax* | 1,273 M | 484 M | 635 M | ||
| Earnings per share | 1.88 | 0.69 | 0.87 | ||
| Cash dividends (NT$/share) |
1.2 | 0.2 | 0.3 | ||
| Stock dividends (NT$/share) |
0.4 | 0.4 | 0.4 | ||
| Pay-out ratio | 85% | 87% | 80% | ||
Note : All of the above figures represent consolidated information
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Quarterly P&L - Consolidated
| In NT$ million, except for EPS 1Q 2016 (Reviewed) 1Q 2015 (Reviewed) YoY |
In NT$ million, except for EPS 1Q 2016 (Reviewed) 1Q 2015 (Reviewed) YoY |
In NT$ million, except for EPS 1Q 2016 (Reviewed) 1Q 2015 (Reviewed) YoY |
In NT$ million, except for EPS 1Q 2016 (Reviewed) 1Q 2015 (Reviewed) YoY |
In NT$ million, except for EPS 1Q 2016 (Reviewed) 1Q 2015 (Reviewed) YoY |
In NT$ million, except for EPS 1Q 2016 (Reviewed) 1Q 2015 (Reviewed) YoY |
|---|---|---|---|---|---|
| In NT$ million, except for EPS | 1Q 2016 (Reviewed) |
1Q 2015 (Reviewed) |
YoY | ||
| Net Sales | 1,022 | 979 | 4% | ||
| Gross Profit | 431 | 344 | 25% | ||
| Gross margin | 42% | 35% | |||
| Operating Expenses | (236) | (203) | 16% | ||
| Operating Income | 195 | 141 | 39% | ||
| Operating margin | 19% | 15% | |||
| Other Rev.(Exp.) | (4) | (7) | -35% | ||
| Net Income before Tax | 191 | 134 | 42% | ||
| Nt Inm ftr T | 172 | 113 | 52% | ||
| e coe ae ax Net margin after tax 17% 12% EPS (after tax) 0.24 0.15 60% |
e coe ae ax | ||||
| Net margin after tax | 17% | 12% | |||
| EPS (after tax) | 0.24 | 0.15 | 60% |
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Balance Sheet- Consolidated
| In NT$ million 2016/3/31 (Reviewed) 2015/3/31 (Reviewed) |
In NT$ million 2016/3/31 (Reviewed) 2015/3/31 (Reviewed) |
In NT$ million 2016/3/31 (Reviewed) 2015/3/31 (Reviewed) |
In NT$ million 2016/3/31 (Reviewed) 2015/3/31 (Reviewed) |
In NT$ million 2016/3/31 (Reviewed) 2015/3/31 (Reviewed) |
In NT$ million 2016/3/31 (Reviewed) 2015/3/31 (Reviewed) |
In NT$ million 2016/3/31 (Reviewed) 2015/3/31 (Reviewed) |
|---|---|---|---|---|---|---|
| In NT$ million | 2016/3/31 (Reviewed) |
2015/3/31 (Reviewed) |
||||
| Cash and Cash Equivalents | 2,560 | 21% | 2,008 | 17% | ||
| Accounts Receivable | 645 | 5% | 653 | 6% | ||
| Inventories | 2,167 | 17% | 2,402 | 21% | ||
| Long-Term Investments | 364 | 3% | 244 | 2% | ||
| Property, plant & equipment | 5,361 | 43% | 5,109 | 44% | ||
| Other assets | 1,394 | 11% | 1,155 | 10% | ||
| Total Assets | 12,491 | 100% | 11,571 | 100% | ||
| 20 Current Liabilities 2,374 19% 2,004 17% L-T Liabilities and Others 90 1% 91 1% Stockholders’ Equities 10,027 80% 9,476 82% |
Current Liabilities | 2,374 | 19% | 2,004 | 17% | |
| L-T Liabilities and Others | 90 | 1% | 91 | 1% | ||
| Stockholders’ Equities | 10,027 | 80% | 9,476 | 82% |
Cash Flows- Consolidated
| In NT$ million 1Q 2016 (Reviewed) 1Q 2015 (Reviewed) |
In NT$ million 1Q 2016 (Reviewed) 1Q 2015 (Reviewed) |
In NT$ million 1Q 2016 (Reviewed) 1Q 2015 (Reviewed) |
In NT$ million 1Q 2016 (Reviewed) 1Q 2015 (Reviewed) |
In NT$ million 1Q 2016 (Reviewed) 1Q 2015 (Reviewed) |
|---|---|---|---|---|
| In NT$ million | 1Q 2016 (Reviewed) |
1Q 2015 (Reviewed) |
||
| Cash and cash equivalents at beginning of period |
2,336 | 1,928 | ||
| Cash flows from operating activities | 663 | 241 | ||
| CAPEX | (263) | (269) | ||
| Short-term borrowings | (16) | 86 | ||
| Others | (160) | 22 | ||
| 14 21 Cash and cash equivalents at end of period 2,560 2,008 |
Cash and cash equivalents at end of period |
2,560 | 2,008 |
2016 Product Launch Plan
| API Region Indication Brand Marketer Regional Sales WW Sales |
API Region Indication Brand Marketer Regional Sales WW Sales |
API Region Indication Brand Marketer Regional Sales WW Sales |
API Region Indication Brand Marketer Regional Sales WW Sales |
API Region Indication Brand Marketer Regional Sales WW Sales |
API Region Indication Brand Marketer Regional Sales WW Sales |
API Region Indication Brand Marketer Regional Sales WW Sales |
API Region Indication Brand Marketer Regional Sales WW Sales |
|---|---|---|---|---|---|---|---|
| API | Region | Indication | 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 Source: : IMS Data (2014Q4-2015Q3) Launched |
. | ||||||
| Tamsulosin HCl |
USA | Benign Prostatic Hyperplasia (BPH) |
Boehringer Ingelheim |
US$410.0M | US$1,818.4M |
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Pipeline Outlook
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4-6 new launches � 5-6 new launches
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5-6 new launches
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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
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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1 drug product launched in China
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Chinese CFDA inspection at SPC
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US FDA inspection at INJ
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Confidential
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Brand Quality with Asian Advantages
www.scinopharm.com
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