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SPT — Investor Presentation 2016
Sep 26, 2016
51922_rns_2016-09-26_47f074c4-981d-47cb-a451-af5370bfd7a4.pdf
Investor Presentation
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TWSE 1789
ScinoPharm
Corporate Presentation
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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 presentation 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.
1
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Overview of ScinoPharm
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32
Confidential
Business Overview
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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 built in Taiwan and expanding in China with a new GMP plant in Changshu & marketing base in Shanghai
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70 generic APIs in current portfolio with 25 APIs launched; 51 US DMFs filed (741 DMFs WW), 30 US DMFs in oncological APIs. 100+ NCE CRAM projects, with 5 APIs launched and 5 in phase III for NDA filing in 2-3 years
-
Fully compliant with world-class cGMPs and international regulatory requirements; Certified by US FDA, EMA, Australian TGA, Japanese PMDA, etc.
3
World Class API Facilities
Taiwan
China
-
6.6 hectares of land, 330K sqft 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, 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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6.5 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 APIs
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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 served including China
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Global Market served
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Strong Generics Product Portfolio
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40
36
35
30
25 23
20
unlaunched
15
11
launched
10 7
5 6
13 4
2 2
5 6 2 2
6
4 3
2 2 2
1 1
0
Note: Other (Women's Health, Gastrointestinal, Immunology and Metabolic)
11
5
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ScinoPharm - Oncology API Leader
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Stand-Alone API Companies
ScinoPharm 30 20
Shilpa 12 11 2
Polymed 10 2 3
MacChem Products 7 5 2 # Oncology DMF Overlap with SPT
# Non-overlapping Oncology DMF
Laurus Labs 7 7 11
# Other DMFs
Sichuan Xieli 6 8 13
Chemwerth 3 5 32
Apicore 5 6 23
0 10 20 30 40 50 60
Large Generic Pharmaceutical Companies
ScinoPharm 30 20
Teva 15 26 247
Dr. Reddy's 15 13 189
Cipla 11 16 128
Sun 17 11 170
Hisun 11 19 48
# Oncology DMF Overlap with SPT
Qilu 8 3 8
# Non-overlapping Oncology DMF
Hengrui 3 3 9 # Other DMFs
0 50 100 150 200 250 300
Source: US FDA DMF Q1 2016 database
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We are Transforming our Company
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synergy of our API business,
to maximize ROI
Positioning as a Transforming into a
Tightening cost control,
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Tapping into formulation
scope based on our core
competencies into high-
entry-barrier APIs
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Keys to Generic Formulation Business
Opportunity
Strategy
Tactics
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Already the leader in providing oncological APIs to regulated markets worldwide
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Already the leader in � Developing dossiers per our � Expanding formulation providing oncological APIs difficult-to-make APIs to portfolio
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to regulated markets increase value proposition � Building on-site worldwide in the supply chain oncology injectable
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� Injectable CMOs are in � Targeted delivery & facility and establishing undersupply condition extended release of proven an integrated supply
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� Can be customer’s APIs via 505(b)2 fast track chain
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injectables provider by � Collaborating with start-ups � promoting our developing formulations & research institutes, formulations via using our own oncological focusing on un-met strategic alliances, APIs or others’ APIs, up to oncology medical needs of especially in China and and including filing for high prevalence in Asia US/EU ANDA with FDA
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Expanding formulation portfolio
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Building on-site oncology injectable facility and establishing an integrated supply chain
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2 US ANDAs
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11 co-developing and cost/profit sharing products with various partners
8
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 |
||
| Genovate | Entecavir | Hepatitis B Viral | Taiwan | 2013* | 1st co-developed formulation product launch | ||
| Sagent | Oncology Injectable |
Myeloid Leukemia | US | 2017 | 1st US ANDA filing, triggered US FDA inspection in Changshu site |
||
| 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 |
||
| Azacitidine | MDS | China | 2021 | Co-developed formulation in China | |||
| Lee’s Pharma |
Fondaparinux | Anti-thrombotic | China | 2021 | Co-development collaboration | ||
| Travoprost Bimatoprost |
Glaucoma | China | 2020 | ||||
| Nanjing King Friend |
Regadenoson | Stress agent for heart scan |
China | 2020 | Co-developed formulation in China | ||
| 9 US partner Project A non-small cell lung cancer US 2020 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 2020 ANDA with Paragraph IV filing / The estimated launch year is subject to litigation results |
US partner |
Project A | non-small cell lung cancer |
US | 2020 | 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 | 2020 | ANDA with Paragraph IV filing / The estimated launch year is subject to litigation results |
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Operating Results & Outlook
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10
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
1,000 872 1,170
1,041 1,040 484
143 961
635
484
0
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
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Recent Financial
Unit: 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 | 1.2 | 0.2 | 0.3 | ||
| Stock dividends | 0.4 | 0.4 | 0.4 | ||
| Pay-out ratio | 85% | 87% | 80% | ||
Note : All of the above figures represent consolidated information
12
Quarterly P&L - Consolidated
| In NT$ million, except for EPS |
2Q,’16 (Reviewed) |
1Q,’16 (Reviewed) |
2Q,’15 (Reviewed) |
QoQ | YoY | ||
|---|---|---|---|---|---|---|---|
| Operating Revenue | 1,015 | 1,022 | 963 | -1% | 5% | ||
| Gross Profit | 465 | 431 | 365 | 8% | 27% | ||
| Gross margin | 46% | 42% | 38% | ||||
| Operating Expenses | (236) | (236) | (239) | 0% | -1% | ||
| Operating Income | 229 | 195 | 126 | 17% | 82% | ||
| Operating margin | 23% | 19% | 13% | ||||
| Other Rev.(Exp.) | (29) | (4) | 106 | 625% | -127% | ||
| Net Income before Tax | 200 | 191 | 232 | 5% | -14% | ||
| Net Income after Tax | 174 | 172 | 132 | 1% | 32% | ||
| 13 Net margin after tax 17% 17% 14% EPS (after tax) 0.24 0.24 0.18 0% 33% |
Net margin after tax | 17% | 17% | 14% | |||
| EPS (after tax) | 0.24 | 0.24 | 0.18 | 0% | 33% |
Half Year P&L - Consolidated
| In NT$ million, except for EPS 1H,’16 (Reviewed) 1H,’15 (Reviewed) YoY |
In NT$ million, except for EPS 1H,’16 (Reviewed) 1H,’15 (Reviewed) YoY |
In NT$ million, except for EPS 1H,’16 (Reviewed) 1H,’15 (Reviewed) YoY |
In NT$ million, except for EPS 1H,’16 (Reviewed) 1H,’15 (Reviewed) YoY |
In NT$ million, except for EPS 1H,’16 (Reviewed) 1H,’15 (Reviewed) YoY |
In NT$ million, except for EPS 1H,’16 (Reviewed) 1H,’15 (Reviewed) YoY |
|---|---|---|---|---|---|
| In NT$ million, except for EPS | 1H,’16 (Reviewed) |
1H,’15 (Reviewed) |
YoY | ||
| Operating Revenue | 2,037 | 1,942 | 5% | ||
| Gross Profit | 896 | 709 | 26% | ||
| Gross margin | 44% | 37% | |||
| Operating Expenses | (471) | (442) | 7% | ||
| Operating Income | 425 | 267 | 59% | ||
| Operating margin | 21% | 14% | |||
| Other Rev.(Exp.) | (34) | 99 | -134% | ||
| Net Income before Tax | 391 | 366 | 7% | ||
| Net Income after Tax | 346 | 245 | 41% | ||
| 14 Net margin after tax 17% 13% EPS (after tax) 0.47 0.34 38% |
Net margin after tax | 17% | 13% | ||
| EPS (after tax) | 0.47 | 0.34 | 38% |
Balance Sheet - Consolidated
| In NT$ million | 2016/6/30 (Reviewed) |
2016/6/30 (Reviewed) |
2015/6/30 (Reviewed) |
2015/6/30 (Reviewed) |
||
|---|---|---|---|---|---|---|
| Cash and Cash Equivalents | 2,964 | 24% | 2,410 | 20% | ||
| Accounts Receivable | 678 | 5% | 568 | 5% | ||
| Inventories | 2,062 | 16% | 2,315 | 19% | ||
| Long-Term Investments | 364 | 3% | 339 | 3% | ||
| Property, plant & equipment | 5,355 | 43% | 5,142 | 43% | ||
| Other assets | 1,122 | 9% | 1,100 | 10% | ||
| Total Assets | 12,545 | 100% | 11,874 | 100% | ||
| Current Liabilities | 2,248 | 18% | 2,333 | 19% | ||
| L-T Liabilities and Others 339 3% 91 1% Stockholders’ Equities 9,958 79% 9,450 80% |
L-T Liabilities and Others | 339 | 3% | 91 | 1% | |
| Stockholders’ Equities | 9,958 | 79% | 9,450 | 80% |
15
Cash Flows - Consolidated
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1H 2016 1H 2015
In NT$ million
(Reviewed) (Reviewed)
Cash and cash equivalents at
2,336 1,928
beginning of period
Cash flows from operating activities 826 589
CAPEX (371) (345)
Short-term borrowings (241) 212
-
Long-term borrowings 255
Others 159 26
Cash and cash equivalents at
2,964 2,410
end of period
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Sales by Business
2016 1H
CRO CMO BD 4% 1% <1%
2015 1H
CMO BD CRO 2% 2% 7%
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Generics
89%
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17
Sales by Indications
2016 1H
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Others
CNS
12%
14%
2015 1H
Oncology
74%
CNS Others
14% 7%
Oncology
Oncology60%
79%
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Sales by Region
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2016 1H
JP
AU+NZ ROW
6%
3% 7%
India
2015 1H
9%
AU+NZ ROW
JP
US+CAN
EU
5% 7%
7%
52%
23%
India
US+CAN
19%
43%
EU
19%
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ScinoPharm Changshu Operationg Update
20
Short-Term Goal
� To provide API contract development and manufacturing services for both multinational and China domestic pharmas
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Major base for large volume API with regulatory supports
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To be able to produce high value added intermediates for SPT
21
The Completive Advantages
- Process Development Capability
Collaborating with a partner specialized in enzymatic technology to integrate with ScinoPharm in-house strong chemical synthesis capabilities for providing services to develop greener, safer, and more cost-effective API manufacturing processes
- GMP Production Capability
Knowledge to design, develop, and test parameters of spray drying process for APIs which are difficult-to-dry, are sensitive to long drying residence time, or require uniform particle size distribution
� Regulatory Compliance Capability Fully compliant with the most advanced guideline published by EMA in 2014 to set the standards for production line segregation and equipment cleaning criteria
22
Operating Progress
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Actively implementing more than 20 contract research or manufacturing projects every year
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9 US/EU customers and 3 of them are top 10 big pharmas
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Strategically partnership with Lee’s Pharma in China to provide API process development and manufacturing services for more than 15 projects
� Successfully passed 14 GMP and 2 EHS audits conducted by customers
23
Selected List of CRAM Projects at Changshu
| Customer Project Type Product Indication/stage Product Type Remarks/ Market Passed Mexican |
Customer Project Type Product Indication/stage Product Type Remarks/ Market Passed Mexican |
Customer Project Type Product Indication/stage Product Type Remarks/ Market Passed Mexican |
Customer Project Type Product Indication/stage Product Type Remarks/ Market Passed Mexican |
Customer Project Type Product Indication/stage Product Type Remarks/ Market Passed Mexican |
Customer Project Type Product Indication/stage Product Type Remarks/ Market Passed Mexican |
Customer Project Type Product Indication/stage Product Type Remarks/ Market Passed Mexican |
|---|---|---|---|---|---|---|
| Customer | Project Type |
Product Indication/stage | Product Type |
Remarks/ Market |
||
| Passed Mexican | ||||||
| Top 10 global pharma | CMO | Approved antidepressant drug in US | GMP Intermediate |
authority (APIF) GMP inspection |
||
| Top 5 global pharma | CMO | Approved African sleeping disease drug | API | Site transfer from Taiwan |
||
| Lee’s Pharma | CRO | +15 items including topical anesthetic, brain tumor, antibiotic, hypertension, eye drop, etc. |
API |
China | ||
| China pharm 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 | ||
| Top 5 global pharma | CRO | Phase II clinical trial for diabetes | Intermediate | US | ||
| 24 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 |
||||||
| 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 |
Key Progress for China Market
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ScinoPharm
Taiwan
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Submitted drug import license applications for 12 APIs (anti-cancer, cardiovascular, Alzheimer's disease, benign prostatic hyperplasia, hepatitis B, etc. )
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ScinoPharm
Changshu
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-
Obtained drug production permits for 11 APIs for anti-cancer, anti-viral, glaucoma, etc. )
-
Submitted 5 drug license applications for USFDA, 1 for EDQM and 2 for CFDA
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Strategic
Alliance
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5 formulation development and 1 new drug projects smoothly undergoing. Expected to be commercially available in 2019-2022
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Business Updates
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26
Injectable Plant Progress
-
Entire facility includes space for R&D, quality control, washing, sterilization, manufacturing, filling, lyophilization, packaging, and storage
-
Granted building use permit at the end of 2015. To complete registration batch production by 2017. Expected to submit the 1st home-made ANDA in 2018 and pass US FDA inspection in 2019
-
Target is injectables with high entry barrier/ high unit-priced generics like oncologicals and peptides. Will offer CMO services for brand drugs and self-developed drug
-
10 drugs planned with the indications of cancer, diabetes, osteoporosis, multiple sclerosis and antinauseant
27
Aseptic Fill & Finish Service
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Vial
Product Line
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28
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 | ||
| 11 Phase III 2017 Ovarian Cancer CN Phase III 2018 Parkinson’s Disease US 29 |
Phase III | 2017 | Ovarian Cancer | CN | |
| Phase III | 2018 | Parkinson’s Disease | US |
2016 1H Major Products - account for 60% of total sales
| API Idii 2015 MKT # of US DMF/EDMF & |
API Idii 2015 MKT # of US DMF/EDMF & |
API Idii 2015 MKT # of US DMF/EDMF & |
API Idii 2015 MKT # of US DMF/EDMF & |
API Idii 2015 MKT # of US DMF/EDMF & |
API Idii 2015 MKT # of US DMF/EDMF & |
|---|---|---|---|---|---|
| API | Idii | 2015 MKT | # of US DMF/EDMF & | ||
| ncatons | Share | other Filings | |||
| Irinotecan HCI |
Antineoplastic | 64% | 62 | ||
| Docetaxel Anhydrous |
Antineoplastic | 33% | 68 | ||
| Paclitaxel | Antineoplastic | 31% | 57 | ||
| Exemestane | Antineoplastic | 18% | 44 | ||
| Galantamine HBr |
Antipsychotic | 12% | 38 | ||
| Gemcitabine Antineoplastic 8% 76 |
Gemcitabine | Antineoplastic | 8% | 76 |
*Source: IMS data from Newport
30
2016 API 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 |
. | ||||||
| Tamsulosin HCl |
USA | Benign Prostatic Hyperplasia (BPH) |
Boehringer Ingelheim |
US$410.0M | US$1,818.4M |
Launched Source: IMS Data (2014Q4-2015Q3) 31
Pipeline
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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 ANDA filing � 1st home-made drug launched in US
2016 2017 2018 2019 2020
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� 3-5 new launches � 6-8 new launches
� Chinese CFDA inspection at SPC
� 1 [st] self-developed US � US FDA inspection at INJ
ANDA launched
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Brand Quality with Asian Advantages www.scinopharm.com
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