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SPT — Investor Presentation 2015
Jan 8, 2015
51922_rns_2015-01-08_6ae42264-a445-465a-ac0d-eb8f1d0693db.pdf
Investor Presentation
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TWSE 1789
ScinoPharm Management Presentation 2015 JP Morgan Healthcare Conference
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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 of ScinoPharm
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- ScinoPharm’s Strategies and Opportunities
� Operating Results & Outlook
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Overview of ScinoPharm - an API + ANDA Company
Active Pharmaceutical Ingredients Abbreviated New D A rug pplication
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Background
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Established in 1997 in Taiwan and listed on TWSE in 2011, current market cap around US$1.3 billion
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Major shareholders include Uni-President Group, National Development Fund, Taiwan Sugar, etc.
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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 potency (steroid/cytotoxic) APIs and expands to injectable formulations
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Expanding in China with a new GMP plant in Changshu & marketing base in Shanghai
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World Class API Facilities
Taiwan
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6.6 hectares of land, 330K sqft facilities with >200M[3] reactor volume
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8 of 18 production lines equipped with high potency capabilities for cytotoxics/steroids
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US FDA approved & 250+ CGMP audits by customers
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Provides comprehensive contract research & manufacturing services for brand drug companies
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Global Market
China
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6.6 hectares of land with ~250M[3 ] reactor volume
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2 of 8 production lines equipped with high potency capabilities for cytotoxics
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cGMP designed facility for intermediates & high potency API
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Full scope capabilities in developing and manufacturing APIs from small to large scale for generic & CRAM markets
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Global market including China
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Confidential
Innovative Injectable Plant
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Confidential
Business Overview
� Risk & return balanced model to offer APIs and fill/finish capability for both generic and new drugs
- 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 7 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
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Sales Distribution
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By Indication
By Business
Others
CMO
15%
CRO 20% Other CNS
3% <1% By Region 22%
Oncology
Rest of AU & NZ ROW 63%
Asia 2% <1%
Generic 11%
India
77%
15%
US &
CAN
EU 53%
Date: up to Q1-Q3 2014 19%
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Confidential
Strong Generics Product Portfolio
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Diversified CRAM Portfolio
Confidential
| Confidential Diversified CRAM Portfolio |
Confidential Diversified CRAM Portfolio |
Confidential Diversified CRAM Portfolio |
Confidential Diversified CRAM Portfolio |
Confidential Diversified CRAM Portfolio |
Confidential Diversified CRAM Portfolio |
|---|---|---|---|---|---|
| Stage First Launch Year Indication Location Commercial 2005 Eluting Stent US Commercial 2009/2013 Skin Infection/HAP US/EU |
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| 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 | 2014 | Infections | US | ||
| Phase III | 2016 | Prostate & Ovarian Cancer | EU | ||
| 11 11 Phase III 2016 Prostate Cancer US Phase III 2016-2017 Ovarian Cancer CN Phase III 2017 Seizure US Phase III 2017 Parkinson’s Disease US Phase III 2017 Opioid-Induced Constipation US 11 |
Phase III | 2016 | Prostate Cancer | US | |
| Phase III | 2016-2017 | Ovarian Cancer | CN | ||
| Phase III | 2017 | Seizure | US | ||
| Phase III | 2017 | Parkinson’s Disease | US | ||
| Phase III | 2017 | Opioid-Induced Constipation | US |
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ScinoPharm’s
Strategies and Opportunities
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Confidential
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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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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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 academic research institutes, focusing on un-met oncological 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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Injectable: 11 drugs planned
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Oral: 10 drugs planned
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Ophthalmic: 3 drugs planned
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To be launched in 2017 through 2024
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Building on-site oncological 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
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Acquiring critical resources via M&A
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Confidential
ScinoPharm - Oncological API Leader
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Confidential
Golden Opportunities in China
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Government’s 12[th] five-year plan encourages pharma industry to grow at a CAGR of 20%
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Tighten GMP requirements to align with US/EU
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Motivate drug makers to improve quality by applying for US ANDAs, which need SPT’s world class APIs
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MNCs and emerging virtual-model players create huge needs in API contract manufacturing in China for compliance
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ScinoPharm timely captures oncological API needs via importing from Taiwan and local made in Changshu sites
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Strategic Alliances
| Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch t* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch t* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch t* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch t* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch t* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch t* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch t* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Viral Taiwan 2013 1st co-developed formulation product launch t* |
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| 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 | 2017 | 1s US ANDA filing to trigger 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 | 2018 | 1st co-developed drug in China to trigger CFDA inspection in Changshu |
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| Azacitidine | MDS | China | 2019 | Co-developed formulation | |||
| Fondaparinux | Anti-thrombotic | China | 2019 | 1st dru in China | |||
| Lee’s Pharma g Travoprost Bimatoprost Glaucoma China 2020 Co-developed formulation Nanjing King Friend Regadenoson Stress agent for heart scan China 2020 1st type 3.1 co-developed new drug in China |
Lee’s Pharma | g | |||||
| Travoprost Bimatoprost |
Glaucoma | China | 2020 | Co-developed formulation | |||
| Nanjing King Friend |
Regadenoson | Stress agent for heart scan |
China | 2020 | 1st type 3.1 co-developed new drug in China |
17 *** Already launched**
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Operating Results & Outlook
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Historical Performance
*** In NT$ million**
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5,085
5,500
4,572
4,500 3,887 3,953
3,791
3,145
3,500
2,494
2,500
1,463
1,010
1,500
572
1,170 1,273
1,040 961
872 1,041
500 613
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(392) (479)
-500
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
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Recent Financial
*** In NT$ million**
| Year 2011 2012 2013 Total assets 9,480 10,339 11,484 hhld’ i** |
Year 2011 2012 2013 Total assets 9,480 10,339 11,484 hhld’ i** |
Year 2011 2012 2013 Total assets 9,480 10,339 11,484 hhld’ i** |
Year 2011 2012 2013 Total assets 9,480 10,339 11,484 hhld’ i** |
Year 2011 2012 2013 Total assets 9,480 10,339 11,484 hhld’ i** |
Year 2011 2012 2013 Total assets 9,480 10,339 11,484 hhld’ i** |
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| Year | 2011 | 2012 | 2013 | ||
| Total assets* | 9,480 | 10,339 | 11,484 | ||
| hhld’ i* | |||||
| Sareoers equty | 8,609 | 9,070 | 9,643 | ||
| Sales* | 3,953 | 4,572 | 5,085 | ||
| Net profit after tax* | 961 | 1,170 | 1,273 | ||
| Earnings per share (NT$) | 1.56 | 1.80 | 1.88 | ||
| Cash dividends (NT$/share) | 1.0 | 1.2 | 1.2 | ||
| Stock dividends (NT$/share) 0.3 0.4 0.4 Pay-out ratio 83% 89% 85% |
Stock dividends (NT$/share) | 0.3 | 0.4 | 0.4 | |
| Pay-out ratio | 83% | 89% | 85% |
Note 1: All of the above figures represent consolidated information. Note 2: Data for 2011 and 2012 reported per the standards set by the Financial Accounting Standards Committee (FASC) in Taiwan; data for 2013 reported per international accounting standards.
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2014 Product Launches
| 2014 Product Launches | 2014 Product Launches | 2014 Product Launches | 2014 Product Launches | 2014 Product Launches | 2014 Product Launches | 2014 Product Launches | 2014 Product Launches |
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| API Region Indications Brand Marketer Regional Sales WW Sales Azacitidine US MDS Oncology Celgene US$358MM US$818MM Dantrolene Malinant JHP** |
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| API | Region | Indications | Brand Marketer | Regional Sales | WW Sales | ||
| Azacitidine | US | MDS Oncology |
Celgene | US$358MM* | US$818MM* | ||
| Dantrolene | Malinant | JHP | |||||
| (injectable) | US | g hyperthermia |
Pharmaceuticals |
US$20MM* | US$46MM* | ||
| Decitabine | US | MDS, AML Oncology |
Eisai | US$250MM* | US$289MM* | ||
| Docetaxel trihydrate |
JP | Oncology | Sanofi Aventis | US$180MM (Taxotere)** |
US$1,422MM* | ||
| Entecavir | TW | Hepatitis B virus | BMS | US$67MM*** | US$1,413MM* | ||
| Exemestane | US | Breast cancer | Pfizer | US$995MM* | US$3001MM* | ||
. . Riluzole (liquid) EU Amyotrophic lateral sclerosis Sanofi Aventis US$66MM US$187MM Zoledronic acid JP Osteoporosis Novartis US$120MM* US$1,361MM*** |
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| Riluzole (liquid) |
EU | Amyotrophic lateral sclerosis |
Sanofi Aventis | US$66MM* | US$187MM* | ||
| Zoledronic acid | JP | Osteoporosis | Novartis | US$120MM*** | US$1,361MM* |
Source: * IMS Data (Year 2013) ** Datamonitor In-house research*
Launched
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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
� US FDA inspection on INJ China
2015 2016 2017 2018 2019 2020
� 5-6 new launches � 5-6 new launches � 7-9 new launches
� 1 [st] ANDA product � 1 [st ] drug product
launched in US launched in China
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Confidential
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Brand Quality with Asian Advantages
www.scinopharm.com
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