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SPT — Interim / Quarterly Report 2016
Nov 9, 2016
51922_rns_2016-11-09_9fedec6e-39db-494b-a8f4-5ce61a3569b1.pdf
Interim / Quarterly Report
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Ticker: TWSE 1789
Third Quarter 2016 Online Investor Meeting
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November 9, 2016
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.
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Table of Content
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� Overview of ScinoPharm
- Financial & Operating Results in Q3, 2016
� Business Updates
2
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Overview of ScinoPharm
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43
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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71 generic APIs in current portfolio with 25 APIs launched; 52 US DMFs filed (743 DMFs WW), 31 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, etc.
4
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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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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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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5
Strong Generics Product Portfolio
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40 36
35
30
25 23
20
12 unlaunched
15
launched
10 6 7
6
13 4
2
5 6 2 2 2
6 3
4
2 2 2
1 1
0
Note: Other (Women's Health, Gastrointestinal, Immunology and Metabolic)
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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
# Oncology DMF Overlap with SPT
MacChem Products 7 5 2 # 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
space related to our core
competencies in 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 oncology APIs to regulated markets worldwide
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Developing dossiers per our difficult-to-make APIs to increase value proposition in the supply chain
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� Targeted delivery & extended release of proven APIs via 505(b)(2) fast track
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Injectable CMOs are in short supply
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Can be customer’s
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injectables provider by � Collaborating with start-ups developing formulations & research institutes, using our own oncology focusing on un-met APIs or others’ APIs, up to oncology medical needs of and including filing for high prevalence in Asia ANDA with FDA
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Expanding formulation portfolio
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Establishing on-site oncology injectable facility and providing an integrated supply chain
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Promoting our formulations via strategic alliances, especially in China and US/EU
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2 US ANDAs
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11 co-developing 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 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 | ||
| 10 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 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 | 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 | 2020 | ANDA with Paragraph IV filing / The estimated launch year is subject to litigation results |
Progress of Injectable Business
| Product Oncology Injectable Fondaparinux Others (10 drugs) |
Product Oncology Injectable Fondaparinux Others (10 drugs) |
Product Oncology Injectable Fondaparinux Others (10 drugs) |
Product Oncology Injectable Fondaparinux Others (10 drugs) |
Product Oncology Injectable Fondaparinux Others (10 drugs) |
Product Oncology Injectable Fondaparinux Others (10 drugs) |
|---|---|---|---|---|---|
| Product | Oncology Injectable |
Fondaparinux | Others (10 drugs) | ||
| Partner | Co-development with Sagent |
US-self development+local marketer CN-collaboration with Lee’s Pharma |
Self development and partnership |
||
| Formulation Production |
Kindos Pharmaceuticals, China |
CMO | CMO + In-house production | ||
| Type | Generic | Generic | New Drug Generic |
||
| Indications | Myeloid Leukemia | Anti-thrombotic | Cancer, diabetes, osteoporosis, multiple sclerosis and antinauseant |
||
| Market Size | US: US$200M | US:US$100M |
|||
| CN:US$80M Launch Year(E) 2017 US:2017 CN:2020 After 2019 11 |
CN:US$80M | ||||
| Launch Year(E) |
2017 | US:2017 CN:2020 |
After 2019 |
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Financial & Operating Results in Q3, 2016
12
Quarterly P&L - Consolidated
| In NT$ million, except for EPS |
3Q,’16 (Reviewed) |
2Q,’16 (Reviewed) |
3Q,’15 (Reviewed) |
QoQ | YoY | ||
|---|---|---|---|---|---|---|---|
| Operating Revenue | 992 | 1,015 | 983 | -2% | 1% | ||
| Gross Profit | 466 | 465 | 453 | ||||
| Gross margin | 47% | 46% | 46% | ||||
| Operating Expenses | (233) | (236) | (234) | ||||
| Operating Income | 233 | 229 | 219 | 2% | 7% | ||
| Operating margin | 24% | 23% | 22% | ||||
| Other Rev.(Exp.) | (26) | (29) | (15) | ||||
| Net Income before Tax | 207 | 200 | 204 | 3% | 1% | ||
| Net Income after Tax | 166 | 174 | 195 | -5% | -15% | ||
| 13 Net margin after tax 17% 17% 20% EPS (after tax) 0.22 0.23 0.26 |
Net margin after tax | 17% | 17% | 20% | |||
| EPS (after tax) | 0.22 | 0.23 | 0.26 |
Cumulative P&L - Consolidated
| In NT$ million, except for EPS 1Q~3Q,’16 (Reviewed) 1Q~3Q,’15 (Reviewed) YoY |
In NT$ million, except for EPS 1Q~3Q,’16 (Reviewed) 1Q~3Q,’15 (Reviewed) YoY |
In NT$ million, except for EPS 1Q~3Q,’16 (Reviewed) 1Q~3Q,’15 (Reviewed) YoY |
In NT$ million, except for EPS 1Q~3Q,’16 (Reviewed) 1Q~3Q,’15 (Reviewed) YoY |
In NT$ million, except for EPS 1Q~3Q,’16 (Reviewed) 1Q~3Q,’15 (Reviewed) YoY |
In NT$ million, except for EPS 1Q~3Q,’16 (Reviewed) 1Q~3Q,’15 (Reviewed) YoY |
|---|---|---|---|---|---|
| In NT$ million, except for EPS | 1Q~3Q,’16 (Reviewed) |
1Q~3Q,’15 (Reviewed) |
YoY | ||
| Net Sales | 3,028 | 2,925 | 4% | ||
| Gross Profit | 1,362 | 1,162 | |||
| Gross margin | 45% | 39% | |||
| Operating Expenses | (704) | (676) | |||
| Operating Income | 658 | 486 | 35% | ||
| Operating margin | 22% | 16% | |||
| Other Rev.(Exp.) | (60) | 85 | |||
| Net Income before Tax | 598 | 571 | 5% | ||
| 14 Net Income after Tax 512 440 16% Net margin after tax 17% 15% EPS (after tax) 0.67 0.58 16% |
Net Income after Tax | 512 | 440 | 16% | |
| Net margin after tax | 17% | 15% | |||
| EPS (after tax) | 0.67 | 0.58 | 16% |
Balance Sheet- Consolidated
| In NT$ million 2016/09/30 2015/09/30 |
In NT$ million 2016/09/30 2015/09/30 |
In NT$ million 2016/09/30 2015/09/30 |
In NT$ million 2016/09/30 2015/09/30 |
In NT$ million 2016/09/30 2015/09/30 |
In NT$ million 2016/09/30 2015/09/30 |
In NT$ million 2016/09/30 2015/09/30 |
|---|---|---|---|---|---|---|
| In NT$ million | 2016/09/30 |
2015/09/30 |
||||
| (Reviewed) | (Reviewed) | |||||
| Cash and Cash Equivalents | 3,137 | 25% | 1,846 | 15% | ||
| Accounts Receivable | 614 | 5% | 648 | 5% | ||
| Inventories | 2,018 | 16% | 2,289 | 19% | ||
| Lon-Term Investments | 364 | 3% | 339 | 3% | ||
| g | ||||||
| Property, plant and equipment | 5,248 | 42% | 5,143 | 43% | ||
| Other Current/Non-Current Assets | 1,128 | 9% | 1,730 | 15% | ||
| Total Assets | 12,509 | 100% | 11,995 | 100% | ||
| Ct Libiliti | 1534 | 12% | 2199 | 18% | ||
| 15 urren aes , , L-T Liabilities and Others 880 7% 95 1% Stockholders’ Equities 10,095 81% 9,701 81% |
urren aes | , | , | |||
| L-T Liabilities and Others | 880 | 7% | 95 | 1% | ||
| Stockholders’ Equities | 10,095 | 81% | 9,701 | 81% |
Cash Flows- Consolidated
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1Q~3Q 2016 1Q~3Q 2015
In NT$ million
(Reviewed) (Reviewed)
Cash and cash equivalents at
2,336 1,928
beginning of period
Cash flows from operating activities 1,130 764
CAPEX (420) (582)
Short-term borrowings (747) 402
-
Long-term borrowings 812
Cash Dividends (219) (141)
Others 245 (525)
Cash and cash equivalents at
3,137 1,846
end of period
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16
Sales by Business
2015 Q1-Q3 BD & CMO CRO Others 1% 5% 2%
2016 Q1-Q3
BD & CMO CRO Others 2% 5% 1%
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92%
Generics
92%
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Sales by Indication
2016 Q1-Q3
Others CNS 10% 13% 2015 Q1-Q3 CNS Others Oncology 77% 11% 4% Oncology 60% Oncology 85% 18
Sales by Region
2016 Q1-Q3
JP AU+NZ ROW 8% 7% 3% 2015 Q1-Q3 India 9% AU+NZ ROW JP 6% 7% EU 6% 21% India 18% US+CAN
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Business Updates
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20
Passed EDQM Inspection Successfully
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Successfully completed a GMP inspection by European Directorate for the Quality of Medicine & (EDQM) for the 1[st] time
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Inspection of sites is a fundamental part of the EDQM's oversight of APIs via the Certificate of Suitability (CEP) system, and is used to determine whether substances are being produced in accordance with the submitted product dossier and Good Manufacturing Practices
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A 3-day onsite inspection to evaluate quality system, facilities, storage, manufacturing, packaging, and labs for 2 APIs with CEP approved from this inspection
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2016 CPhI WW Trend Observations
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Big pharmas focus on core business via downsizing and outsourcing Accelerate our new generic API and CRAM business model
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High-end APIs outsourced to India/China have gradually returned to US/EU due to GMP compliance risks and rise in cost ScinoPharm’s proven track record of high quality timely captures the high-end API business
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High demand for oncology sterile injectable drugs Vertical integration including formulation by developing our own injectable drugs and building our oncology injectable plant
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M&A activity within the global generic industry leading to hybrid generic-branded models
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ScinoPharm exploring new business models according to customers’ M&A activities
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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 2018 Parkinson’s Disease US |
Phase III | 2017 | Ovarian Cancer | CN | |
| Phase III | 2018 | Parkinson’s Disease | US |
*** Filed**
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23
Selected List of CRAM Projects at Changshu
| Selected List of CRAM Projects at Changshu | Selected List of CRAM Projects at Changshu | Selected List of CRAM Projects at Changshu | Selected List of CRAM Projects at Changshu | Selected List of CRAM Projects at Changshu | Selected List of CRAM Projects at Changshu | 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) |
||||||
| 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 |
||
| Lee’s Pharma | CRO / CMO |
>15 projects, including topical anesthetic, brain tumor, antibiotic, hypertension, eye drops, etc. |
API | China | ||
| China pharm company | CRO | Phase II/ III clinical trial for cancer | API | China | ||
| h b f ld l | ||||||
| China pharm company | CRO | Pase II or age-reate macuar 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 | ||
| Alsan Pharmaceuticals | CRO | Phase II clinical trial for cancer | API | China/Global | ||
| Top 5 global pharma | CRO | Phase II 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 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 |
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 syndrome (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, and Breast Cancers |
Eli Lilly | N/A | US$547.9M | ||
| Launched 25 Source: IMS Data (2014Q4-2015Q3) . 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 |
Pipeline Outlook
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� 5-6 new launches
� 5-6 new launches
� 1 [st ] in-house drug US ANDA filing � 3 drug products launched in China
� 1st in-house drug launched in US
2017 2018 2019 2020
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3-5 new launches � 6-8 new launches
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� 1[st] co-developed US ANDA � Chinese CFDA inspection at Chnagshu site launched � US FDA inspection at injectable plant
-
� 1[st] self-developed US ANDA launched 26
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uestions Q
& Answers
27
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Brand Quality with Asian Advantages www.scinopharm.com
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