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SPT — Investor Presentation 2017
Jan 9, 2017
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Investor Presentation
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1789 TT
ScinoPharm Management Presentation 2017 JP Morgan Healthcare Conference
January 11, 2017
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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 - Formulation Business
- China Market
- Operating Results & Outlook
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Overview of ScinoPharm
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Background
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Company specializes in high potency (steroid/cytotoxic) APIs and is expanding into sterile/aseptic injectable formulations
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Facility & organization established in Taiwan and expanding in China with a new GMP plant in Changshu & marketing base in Shanghai
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72 generic APIs in current portfolio with 25 APIs launched; 53 US DMFs filed (752 DMFs WW), 32 US DMFs in oncology APIs. 100+ NCE CRAM projects, with 5 APIs launched and 5 in phase III for NDA filing in 1-3 years
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Fully compliant with world-class cGMPs and international regulatory requirements; Certified by US FDA, EMA, EDQM, Australian TGA, Japanese PMDA
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World Class API Facilities
Taiwan
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6.6 hectares of land, 330K sq.ft. facilities with >200M[3] reactor volume
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5 of 16 production lines equipped with high potency capabilities for cytotoxic/steroids
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Passed US FDA, EMA, EDQM, 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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China
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6.7 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 the development and production of APIs on small to large scales for generic & CRAM markets
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Global market including China
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Confidential
Strong Generics Product Portfolio
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40 unlaunched
launched
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30
25 23
20
13
15
7 7
10 6
13 4
5 6 2 2 2 2
6 4 3
1 2 2 2 1
0
Note: Other (Women's Health, Gastrointestinal, Immunology and Metabolic)
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Diversified CRAM Portfolio
Confidential
*** Already Filed**
| Confidential Diversified CRAM Portfolio * Already Filed |
Confidential Diversified CRAM Portfolio * Already Filed |
Confidential Diversified CRAM Portfolio * Already Filed |
Confidential Diversified CRAM Portfolio * Already Filed |
Confidential Diversified CRAM Portfolio * Already Filed |
Confidential Diversified CRAM Portfolio * Already Filed |
|---|---|---|---|---|---|
| Stage First Launch Year Indication Market(s) Commercial 2005 Eluting Stent US Commercial 2009/2013 Skin Infection/HAP US/EU |
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| **Stage ** | First Launch Year | Indication | Market(s) | ||
| 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 | Market(s) | ||
| Phase III | 2016* | Infectious Disease | US / EU / Asia | ||
| Phase III | 2017 | Ovarian Cancer | US / EU | ||
| 11 8 8 Phase III 2017 Prostate Cancer US Phase III 2017 Ovarian Cancer CN Phase III 2018 Parkinson’s Disease US |
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| Phase III | 2017 | Prostate Cancer | US | ||
| Phase III | 2017 | Ovarian Cancer | CN | ||
| Phase III | 2018 | Parkinson’s Disease | US |
Confidential
ScinoPharm - Oncology API Leader
Stand-Alone API Companies
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ScinoPharm 31 21
Shilpa 12 11 3
Polymed 10 2 3
MacChem Products 6 5 2 # Oncology DMF Overlap with SPT
# Non-overlapping Oncology DMF
Laurus Labs 7 7 14
# Other DMFs
Sichuan Xieli 6 8 13
Chemwerth 3 5 33
Apicore 5 6 24
0 10 20 30 40 50 60
Large Generic Pharmaceutical Companies
ScinoPharm 31 21
Teva 17 26 249
Dr. Reddy's 14 14 187
Cipla 11 17 125
Sun 17 11 174
Hisun 11 19 48 # Oncology DMF Overlap with SPT
Qilu 8 3 8 # Non-overlapping Oncology DMF
# Other DMFs
Hengrui 33 10
0 50 100 150 200 250 300
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9 Source: USFDA DMF Q3 2016 database
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Confidential
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2016 Sales Distribution
By Indication
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Others
12%
CNS
By Business 12%
BD&
CMO
Others
CRO 2% Oncology
<1% By Region
12% 76%
Oncology
AZ+NZ
ROW
China 63%
2%
7%
JP 4%
Generics
8%
Generic 86%
77% India
10%
US+CAN
EU
49%
20%
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ScinoPharm’s
Strategies and Opportunities
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Confidential
We are Transforming our Company
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Transforming into a
Positioning as a
Gateway into China full-scope pharma Tightening cost control, and
process optimization with
providing Supply-Chain company by executing
enhanced management
to Multinationals
“Double A” strategy
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Keys to Generic Formulation Business
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Opportunity Strategy Tactics
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� Already the leader in providing � Developing dossiers per our � Expanding formulation oncology APIs to regulated difficult-to-make APIs to increase portfolio markets worldwide value proposition in the supply � Establishing on-site
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� Injectable CMOs are in short chain oncology injectable facility supply � Targeted delivery & extended and providing an integrated
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� Can be customer’s injectables release of proven APIs via supply chain provider by developing 505(b)(2) fast track � Promoting our formulations formulations using our own � Collaborating with start-ups & via strategic alliances, oncology APIs or others’ APIs, research institutes, focusing on especially in China and up to and including ANDA filing un-met oncology medical needs US/EU with FDA of high prevalence in Asia
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2 US ANDAs
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11 co-development and cost/profit sharing products with various partners
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Strategic Alliance Highlights * Already launched
| Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Sagent Oncology Injectable Myeloid Leukemia US 2017 1st US ANDA filing, triggering US FDA inspection in Chanshu China site* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Sagent Oncology Injectable Myeloid Leukemia US 2017 1st US ANDA filing, triggering US FDA inspection in Chanshu China site* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Sagent Oncology Injectable Myeloid Leukemia US 2017 1st US ANDA filing, triggering US FDA inspection in Chanshu China site* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Sagent Oncology Injectable Myeloid Leukemia US 2017 1st US ANDA filing, triggering US FDA inspection in Chanshu China site* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Sagent Oncology Injectable Myeloid Leukemia US 2017 1st US ANDA filing, triggering US FDA inspection in Chanshu China site* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Sagent Oncology Injectable Myeloid Leukemia US 2017 1st US ANDA filing, triggering US FDA inspection in Chanshu China site* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Sagent Oncology Injectable Myeloid Leukemia US 2017 1st US ANDA filing, triggering US FDA inspection in Chanshu China site* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Sagent Oncology Injectable Myeloid Leukemia US 2017 1st US ANDA filing, triggering US FDA inspection in Chanshu China site* |
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| Partner | Product |
Indications |
Region |
Launch Year(E) |
Remarks |
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| Genovate | Entecavir | Hepatitis B Virus | Taiwan | 2013* | 1st co-developed formulation product launch | ||
| Sagent | Oncology Injectable |
Myeloid Leukemia | US | 2017 | 1st US ANDA filing, triggering US FDA inspection in Chanshu China site |
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| g, | |||||||
| Foresee | Leuprolide | Prostate cancer | US | 2018 | 505(b)(2) NDA CRAM + Equity | ||
| Coland | Bortezomib | Multiple Myeloma | China | 2020 | 1st co-developed drug in China to trigger CFDA inspection in Changshu site |
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| Azacitidine | MDS | China | 2021 | Co-developed formulation in China | |||
| Lee’s Pharma |
Fondaparinux | Anti-thrombotic | China | 2021 | Co-development collaboration | ||
| Travoprost Bimatoprost |
Glaucoma | China | 2021 | ||||
| 14 Nanjing King Friend Regadenoson Stress agent for heart scan China 2020 Co-developed formulation in China US partner Project A Non-small cell lung cancer US 2018 US NDA 505(b)(2) with Paragraph IV filing / The estimated launch year is subject to litigation results US & China partners Project B Imaging agent US 2021 ANDA with Paragraph IV filing / The estimated launch year is subject to litigation results |
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| Nanjing King Friend |
Regadenoson | Stress agent for heart scan |
China | 2020 | Co-developed formulation in China | ||
| US partner | Project A | Non-small cell lung cancer |
US | 2018 | US NDA 505(b)(2) with Paragraph IV filing / The estimated launch year is subject to litigation results |
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| 14 US & China partners |
Project B | Imaging agent | US | 2021 | ANDA with Paragraph IV filing / The estimated launch year is subject to litigation results |
In-House Injectable Plant Progress and Outlook
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Taiwan-based facility will accommodate R&D, Quality Control, washing, sterilization, manufacturing, filling, lyophilization, packaging, and storage.
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Planned registration batch production by 2017. Expected to submit the first in-house ANDA in 2018 and pass US FDA inspection in 2019
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Target products with high entry barrier or unit-pricing as in peptides and oncology agents.
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Offering CMO services for both brand and proprietary drugs
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Nine drug products planned in the indications of cancer, diabetes, osteoporosis, multiple sclerosis, and anti-emesis
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Confidential
Aseptic Fill & Finish Service
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Vial
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Confidential
Capturing Chinese Growth on Multiple Fronts
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MNCs and emerging virtual-model players create a sizable demand in high-quality and compliant API contract manufacturing in China.
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Existing review and approval mechanisms significantly raise the entry barrier and cost structure in the Chinese drug market, requiring dedication to quality and innovation.
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We have domestic presence plus world-class strength in:
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Global, first-tier customer base
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High-technical-barrier oncology APIs
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Quality and EHS/GMP compliance
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Strategic Goals in China
Short Term: Pass CFDA/EMA/EDQM inspections and expand CRAM services to diversified indications & processes to optimize portfolio and capacity utilization
Mid Term: Execute API+ANDA strategy by collaborating with formulators to apply for ANDA in US/EU/CN and share profits from drug product sales globally
Long Term: Expand into new delivery formulations and new drugs via strategic alliances, investments, and M&A
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Confidential
Selected List of CRAM Projects at Changshu
| Confidential Selected List of CRAM Projects at Changshu |
Confidential Selected List of CRAM Projects at Changshu |
Confidential Selected List of CRAM Projects at Changshu |
Confidential Selected List of CRAM Projects at Changshu |
Confidential Selected List of CRAM Projects at Changshu |
Confidential Selected List of CRAM Projects at Changshu |
Confidential Selected List of CRAM Projects at Changshu |
|---|---|---|---|---|---|---|
| Customer Project Type Product Indication/stage Product Type Remarks/ Market Top 10 global pharma CMO Approved antidepressant drug in US GMP Intermediate Passed Mexican authority (APIF) GMP inspection Top 5 global pharma CMO Approved African sleeping disease drug API Site transfer from Taiwan |
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| Customer | Project Type |
Product Indication/stage | Product Type | Remarks/ Market | ||
| Top 10 global pharma | CMO | Approved antidepressant drug in US | GMP Intermediate |
Passed Mexican authority (APIF) GMP inspection |
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| Top 5 global pharma | CMO | Approved African sleeping disease drug | API | Site transfer from Taiwan | ||
| Lee’s Pharma | CRO / CMO | >15 projects, including brain tumor, antibiotic, hypertension, eye drops, etc. |
API | China | ||
| Chinapharm company | CRO | Phase II/ III clinical trial for cancer | API | China | ||
| China pharm company | CRO | Phase IIb for age-related macular degeneration | API | US/China | ||
| Taigen Biotech | CRO | Phase II clinical trial for myocardial infarction | API | China/Taiwan | ||
| US-based new drug company | CRO | Phase II clinical trial for prevention of HIV infection |
API | US | ||
| Aslan Pharmaceuticals CRO Phase II clinical trial for cancer API China/Global Top 5 global pharma CRO Phase III clinical trial for diabetes Intermediate US Top 5 global pharma CRO Phase I clinical trial API NA US NASDAQ listed pharma CRO Phase III clinical trial for opioid-induced constipation Crude API US US-based new drug company CRO Phase I clinical trial for sickle cell disease API US 20 |
Aslan Pharmaceuticals | CRO | Phase II clinical trial for cancer | API | China/Global | |
| Top 5 global pharma | CRO | Phase III clinical trial for diabetes | Intermediate | US | ||
| Top 5 global pharma | CRO | Phase I clinical trial | API | NA | ||
| US NASDAQ listed pharma | CRO | Phase III clinical trial for opioid-induced constipation |
Crude API | US | ||
| US-based new drug company | CRO | Phase I clinical trial for sickle cell disease | API | US |
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Operating Results & Outlook
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Historical Performance
Unit: millions of NT$
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5,088
4,572
5,000
3,887 3,953 4,098 3,955 4,031
3,791
4,000
3,145
2,494
3,000
2,000
872
613 1,041
1,273 For Q1-Q3
1,000 1,040 961 1,170
484 only
484 635
512
0
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
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Recent Financials
In NT$
| Year 2013 2014 2015 Total assets 11,484 M 11,372 M 12,222 M |
Year 2013 2014 2015 Total assets 11,484 M 11,372 M 12,222 M |
Year 2013 2014 2015 Total assets 11,484 M 11,372 M 12,222 M |
Year 2013 2014 2015 Total assets 11,484 M 11,372 M 12,222 M |
Year 2013 2014 2015 Total assets 11,484 M 11,372 M 12,222 M |
Year 2013 2014 2015 Total assets 11,484 M 11,372 M 12,222 M |
|---|---|---|---|---|---|
| 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 | 1.2 | 0.2 | 0.3 | ||
| Stock dividends | 0.4 | 0.4 | 0.4 | ||
| Pay-out ratio 85% 87% 80% |
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| Pay-out ratio | 85% | 87% | 80% |
Note : All of the above figures represent consolidated information
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2017 Product Launch Plan
| Type Product Region Indication Brand Marketer Regional Sales WW Sales |
Type Product Region Indication Brand Marketer Regional Sales WW Sales |
Type Product Region Indication Brand Marketer Regional Sales WW Sales |
Type Product Region Indication Brand Marketer Regional Sales WW Sales |
Type Product Region Indication Brand Marketer Regional Sales WW Sales |
Type Product Region Indication Brand Marketer Regional Sales WW Sales |
Type Product Region Indication Brand Marketer Regional Sales WW Sales |
Type Product Region Indication Brand Marketer Regional Sales WW Sales |
Type Product Region Indication Brand Marketer Regional Sales WW Sales |
|---|---|---|---|---|---|---|---|---|
| Type | Product | Region | Indication | Brand Marketer |
Regional Sales |
WW Sales | ||
| API | Desmopressin Acetate |
USA | Polyuria | Ferring | US$166M | US$405M | ||
| API | Tamsulosin HCl |
USA | Benign Prostatic Hyperplasia (BPH) |
Boehringer Ingelheim |
US$333M | US$1706M | ||
| Generic Drug |
Oncology Injectable |
US | Myeloid Leukemia |
MDS | US$183M | US$278M | ||
| CMO Project Oral USA EU Antibiotics N/A N/A N/A |
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| CMO Project |
Oral | USA EU |
Antibiotics | N/A | N/A | N/A |
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Source: IMS Data (2015Q3-2016Q2)
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Pipeline Outlook
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3-5 new launches
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1[st ] in-house drug US ANDA filing
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1[st] self-developed US ANDA launched
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� 1 co-developed US ANDA launched
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4-5 new launches
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2 co-developed China ANDAs launched
2017 2018 2019 2020
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2 new launches
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1[st] co-developed US ANDA launched
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5-6 new launches
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1 drug products launched in US
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Chinese (CFDA) inspection at Changshu site
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US FDA inspection at Injectable plant
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Confidential
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Brand Quality with Asian Advantages
www.scinopharm.com 1789 TT
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