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SPT — Investor Presentation 2016
Jan 13, 2016
51922_rns_2016-01-13_ab13e168-0830-4178-bdd0-557b91f60f47.pdf
Investor Presentation
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TWSE 1789
ScinoPharm Management Presentation 2016 JP Morgan Healthcare Conference
Yung Fa Chen, Ph.D. President & CEO
Patricia Chou CFO & VP Corporate Development
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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
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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$1.2 billion
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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
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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 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
China
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6.6 hectares of land with > 250M[3 ] reactor volume
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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
� Risk & return balanced model to offer APIs and sterile filling capability for both generic and new drugs
- 80+ generic APIs developed with 27 APIs launched; 55 US DMFs filed (733 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; The Qualified Asian supplier to provide APIs to global market for multiple commercial NCEs
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Confidential
By Indication
2015 Sales Distribution
CNS Others
17% 7%
By Business
CMO BD Oncology
CRO 8% 2% By Region 76%
5%
Rest of Oncology
ROW
Asia AU&NZ 63%
<1%
Generics
12% 5%
85%
Generic
77% India
US&CAN
18%
42%
EU
23%
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Strong Generics Product Portfolio
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Confidential
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45 42
40
28
35
30
25
20
unlaunched
3
15
9 launched
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7
10
3 4 5
3 3
5 6 2 2 2 2 2
6 2 2 3
1 1 1 2 1 3 2 2 2
0
2
9
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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 | 2016 | Infections | US / EU / Asia | ||
| Phase III | 2017 | Ovarian Cancer | US / EU | ||
| 11 10 Phase III 2017 Prostate Cancer US Phase III 2017 Ovarian Cancer CN Phase III 2017 Seizure US Phase III 2017 Parkinson’s Disease US 10 |
Phase III | 2017 | Prostate Cancer | US | |
| Phase III | 2017 | Ovarian Cancer | CN | ||
| Phase III | 2017 | Seizure | US | ||
| Phase III | 2017 | Parkinson’s Disease | 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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:
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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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:
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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
� Sustaining B2B model, promoting our formulations via strategic alliance, especially in China and US/EU
- Acquiring critical resources via M&A
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Strategic Alliance Highlights
| Strategic Alliance Highlights | Strategic Alliance Highlights | Strategic Alliance Highlights | Strategic Alliance Highlights | Strategic Alliance Highlights | Strategic Alliance Highlights | Strategic Alliance Highlights | Strategic Alliance Highlights |
|---|---|---|---|---|---|---|---|
| Partner Product Indications Region Launch Year(E) Remarks 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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| Partner | Product |
Indications |
Region |
Launch Year(E) |
Remarks | ||
| 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 | 2021 | Co-developed formulation | |||
| Lee’s Pharma |
Fondaparinux | Anti-thrombotic | China | 2022 | 1st self-developed drug in China | ||
| Travoprost Bimatoprost |
Glaucoma | China | 2022 | Co-developed formulations | |||
| Nanjing |
Regadenoson | Stress agent for heart scan | China | 2021 | 1st type 3.1 co-developed new drug in China | ||
| King Friend US partner Project A non-small cell lung cancer US 2018 US NDA 505(b)2 & Paragraph IV filing US & China partners Project B imaging agent US 2018 Paragraph IV filing |
King Friend | ||||||
| US partner | Project A | non-small cell lung cancer | US | 2018 | US NDA 505(b)2 & Paragraph IV filing | ||
| US & China partners |
Project B | imaging agent | US | 2018 | Paragraph IV filing |
*** Already launched**
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ScinoPharm - Oncology API Leader
Confidential
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Stand-Alone API Company
ScinoPharm 29 26
Shilpa 12 9 2
Polymed 10 1 3
MacChem Products 7 5 2 # Oncology DMF Overlap with SPT
# 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
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0 50 100 150 200 250 300
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Confidential
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ScinoPharm Pipeline Echoes Therapy Trend
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Ophthalmology 3%
Genetic disorder 3% Others 3% Chemotherapy Supportive
care
9%
Respiratory 3%
5%
Gastrointestinal 6%
Hormonal
therapy
Infectious 9%
disease Oncology
6% 34%
Targeted
Metabolic therapy
disorder
77%
10% CNS
CV
12%
10%
Immunology
10%
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Confidential
Forces Reshaping Chinese Pharma Market
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Policy reform expediting drug approvals, allowing new drug developers to own drug licenses without manufacturing sites
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Significantly lifting the cost structure & entry barrier in Chinese drug market, with a heavy focus on quality and innovation
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Motivating 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 creating huge needs in API contract manufacturing in China for global compliance
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Advantages in Growing Chinese Market
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Direct benefit from the new GMP standards and policy reform
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Tailor-made product portfolio for Chinese market
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Domestic presence plus world-class strengths in:
*** High-technical-barrier oncology APIs**
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Global first tier customer base
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Quality and EHS/GMP compliance
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Bridge between Chinese and global markets
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Portfolio for Chinese Aging Society
� 14 drug licenses applied and 6 collaborated with local marketers for popular age-related diseases in China
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Benazepril as the first granted import drug license
Oncology Cardiovascular Urology Glaucoma Alzheimer Others Anastrozole Benazepril *Tamsulosin Bimatoprost Galantamine Celecoxib Capecitabine Bivalirudin Travoprost Entecavir Docetaxel Fondaparinux Dantrolene Gemcitabine Regadenoson Irinotecan Paclitaxel Azacitidine Bortezomib
- Submit drug import license applications or production permits
**Co-developed product targeted for Chinese market
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Operating Results & Outlook
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Historical Performance
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Unit: In NT$ million * For Q1-Q3 only
5,088
5,000 4,572
4,098
3,887 3,953 3,955
3,791
4,000
3,145
3,000 2,494
2,000 1,463
613 1,273 484
1,000 872 1,041 1,040 1,170
143
961
484 440
0
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
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Recent Financial
*** In NT$ million**
| Year 2013 2014 Q1-Q3 or 9/30 2015 Total assets* 11,484M 11,372M 11,995M |
Year 2013 2014 Q1-Q3 or 9/30 2015 Total assets* 11,484M 11,372M 11,995M |
Year 2013 2014 Q1-Q3 or 9/30 2015 Total assets* 11,484M 11,372M 11,995M |
Year 2013 2014 Q1-Q3 or 9/30 2015 Total assets* 11,484M 11,372M 11,995M |
Year 2013 2014 Q1-Q3 or 9/30 2015 Total assets* 11,484M 11,372M 11,995M |
Year 2013 2014 Q1-Q3 or 9/30 2015 Total assets* 11,484M 11,372M 11,995M |
|---|---|---|---|---|---|
| Year | 2013 | 2014 | Q1-Q3 or 9/30 2015 |
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| Total assets* | 11,484M | 11,372M | 11,995M | ||
| Shareholders’ equity* | 9,643M | 9,380M | 9,701M | ||
| Sales* | 5,088M | 4,098M | 2,925M | ||
| Net profit after tax* | 1,273M | 484M | 440M | ||
| Earnings per share (NT$) | 1.88 | 0.69 | 0.60 | ||
| Cash dividends (NT$/share) 1.2 0.2 - Stock dividends (NT$/share) 0.4 0.4 - Pay-out ratio 85% 87% - |
Cash dividends (NT$/share) | 1.2 | 0.2 | - | |
| Stock dividends (NT$/share) | 0.4 | 0.4 | - | ||
| Pay-out ratio | 85% | 87% | - |
Note : All of the above figures represent consolidated information
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2016 API Product Launches
| 2016 API Product Launches | 2016 API Product Launches | 2016 API Product Launches | 2016 API Product Launches | 2016 API Product Launches | 2016 API Product Launches | 2016 API Product Launches | 2016 API Product Launches |
|---|---|---|---|---|---|---|---|
| Product Name Region Indications Brand Marketer Regional Sales WW Sales Azacitidine USA Myelodysplastic syndromes (MDS) Celgene US$257.2M US$771.9M** |
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| Product Name | Region | Indications | Brand Marketer | Regional Sales* | WW Sales* | ||
| Azacitidine | USA | Myelodysplastic syndromes (MDS) |
Celgene | US$257.2M | US$771.9M | ||
| Desmopressin Acetate |
USA | Polyuria | Ferring | US$140.1M | US$393.3M | ||
| Entecavir | USA, Singapore, Australia |
Hepatitis B Virus (HBV) |
Bristol-Myers | US$286M (USA only) |
US$1591.6M | ||
| Flumazenil | Korea | Reversal of the sedative effects of benzodiazepines |
Roche | N/A | US$86.2M | ||
| Pancreas, Lung, | |||||||
| Gemcitabine HCl Middle East Ovary, Breast Cancers. Eli Lilly N/A US$583.4M Tamsulosin USA Benign Prostatic Hyperplasia (BPH) Boehringer Ingelheim US$411.1M US$1853.2M |
Gemcitabine HCl | Middle East | Ovary, Breast Cancers. |
Eli Lilly | N/A | US$583.4M | |
| Tamsulosin | USA | Benign Prostatic Hyperplasia (BPH) |
Boehringer Ingelheim | US$411.1M | US$1853.2M |
Source *IMS Data (2014Q3-2015Q2)
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Pipeline Outlook
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� 4-6 new launches � 5-6 new launches � 5-6 new launches
� 1 [st] co-developed US � 1 [st ] home-made drug US � 3 drug products launched in China
ANDA launched � 1 [st ] home-made drug launched in US
ANDA filing
2016 2017 2018 2019 2020
� 3-5 new launches � 6-8 new launches
� 1 [st] self-developed US � SPC China FDA inspection
� 3 drug products launched in China
ANDA launched
� 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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