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SPT — Investor Presentation 2017
Oct 30, 2017
51922_rns_2017-10-30_f71f5a04-024f-4194-9cad-a12d765b4257.pdf
Investor Presentation
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Ticker: TWSE 1789
ScinoPharm Management Presentation
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May 9, 2017
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 Contents
- Overview of ScinoPharm
� Financial & Operating Results in Q1, 2017
- Business Updates
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Overview of ScinoPharm
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4
Confidential
Business Overview
-
Company specializes in high potency (steroid/cytotoxic) APIs and is expanding into sterile/aseptic injectable formulations
-
Facility & organization established in Taiwan and expanding in China with a new GMP plant in Changshu & marketing base in Shanghai
-
72 generic APIs in current portfolio with 25 APIs launched; 53 US DMFs filed (759 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
-
Fully compliant with world-class cGMPs and international regulatory requirements; Certified by US FDA, EMA, EDQM, Australian TGA, Japanese PMDA
5
World Class API Facilities
Taiwan
China
-
6.6 hectares of land, 330K sq.ft. facilities � 6.7 hectares of land with > 250M[3] reactor with >200M[3] reactor volume volume
-
� 5 of 16 production lines equipped with high � 3 of 7 production lines equipped with high potency capabilities for cytotoxic/steroids potency capabilities for cytotoxics
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� Passed US FDA, EMA, EDQM, Australian � US FDA approved cGMP facility for TGA, Japanese PMDA inspections, & 300+ intermediates & high potency API cGMP customer audits
-
Full scope capabilities in the development
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� Provides comprehensive contract research & and production of APIs on small to large manufacturing services for brand drug scales for generic & CRAM markets companies � Global market including China
-
� Global Market
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Strong Generics Product Portfolio
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40 36
unlaunched
35 launched
30
25 23
20
13
15
7
10 7 6
4
13
2 2 2 2
5 6
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
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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 3 3 10
0 50 100 150 200 250 300
Source: US FDA DMF Q3 2016 database
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We are Transforming our Company
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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
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Opportunity Strategy Tactics
� Already the leader in � Developing dossiers per � Expanding
providing oncology APIs our difficult-to-make APIs formulation portfolio
to regulated markets to increase value � Establishing on-site
worldwide proposition in the supply oncology injectable
� Injectable CMOs are in chain facility and providing
short supply. � Targeted delivery & an integrated supply
� Can be customer’s extended release of chain
injectables provider by proven APIs via 505(b)(2) � Promoting our
developing fast track formulations via
formulations using our � Collaborating with start- strategic alliances,
own oncology APIs or ups & research institutes, especially in China
others’ APIs, up to and focusing on un-met and US/EU
including ANDA filing oncology medical needs
with FDA of high prevalence in Asia
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Financial & Operating Results in Q1,2017
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Quarterly P&L - Consolidated
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Q1, 2017 Q1, 2016
In NT$ million, except for EPS YoY
(Reviewed) (Reviewed)
Operating Revenue * 919 1,022 -10%
Gross Profit 470 431 9%
Gross margin 51% 42%
Operating Expenses (249) (236) 6%
Operating Income 221 195 13%
Operating margin 24% 19%
Other Rev. (Exp.) (29) (4)
Net Income before Tax 192 191 1%
Net Income after Tax 170 172 -1%
Net margin after tax 19% 17%
EPS (after tax) 0.22 0.23
*
Taiwan New Dollar per 1 US Dollar quarterly average:
2017Q1: 30.93, 2016Q1: 33.16
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Balance Sheet- Consolidated
| In NT$ million | 2017/03/31 (Reviewed) |
2017/03/31 (Reviewed) |
2016/03/31 (Reviewed) |
2016/03/31 (Reviewed) |
||
|---|---|---|---|---|---|---|
| Cash and Cash Equivalents | 3,715 | 29% | 2,560 | 21% | ||
| Accounts Receivable | 635 | 5% | 645 | 5% | ||
| Inventories | 1,941 | 15% | 2,167 | 17% | ||
| Long-Term Investments | 364 | 3% | 364 | 3% | ||
| Property, Plant & Equipment | 5,155 | 40% | 5,361 | 43% | ||
| Other Current/Non-Current Assets | 1,043 | 8% | 1,394 | 11% | ||
| Total Assets | 12,853 | 100% | 12,491 | 100% | ||
| Current Liabilities | 1,692 | 13% | 2,374 | 19% | ||
| Long-Term & Other Liabilities 803 6% 90 1% Stockholders’ Equities 10,358 81% 10,027 80% 13 |
Long-Term & Other Liabilities | 803 | 6% | 90 | 1% | |
| Stockholders’ Equities | 10,358 | 81% | 10027 | 80% | ||
| , |
Cash Flows- Consolidated
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Q1, 2017 Q1, 2016
In NT$ million
(Reviewed) (Reviewed)
Cash and cash equivalents
3,707 2,336
at beginning of period
Cash flows from operating activities 304 663
CAPEX (203) (264)
Short-term borrowings (51) (16)
-
Long-term borrowings (41)
Others (1) (159)
Cash and cash equivalents
3,715 2,560
at end of period
Free Cash flow 101 399
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Sales by Business
2017 Q1
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BD&
CMO other
2016 Q1
8% 6%
CRO
5%
CMO BD
CRO
1% 1%
6%
Generics
81%
Generics
92%
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Sales by Indications
2017 Q1
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Others
12%
2016 Q1 CNS
11%
Others
Oncology
CNS 14%
77%
11%
Oncology
75%
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Sales by Region
2017 Q1
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JP
CN ROW
8%
2% 5%
India
5%
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2016 Q1
5%
CN ROW US+CAN
JP
EU
<1% 10% 44%
8%
36%
India
3%
EU
US+CAN
25%
54%
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Business Updates
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Confidential
Business Growth Drivers
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CRAM has promising development potential in the next three years − Focus on small-molecule targeted therapies and CNS agents based on new mode of action
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Provide integrated service from API to formulation for niche injectables
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Active development of Chinese and Japanese market
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Target projects to utilize capacity and accelerate growth for Changshu site
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− Develop partnership with major Japanese pharmaceutical companies and international pharmaceutical groups with Japan-based operation site
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Deploying the network of development, production and distribution of injectable products
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Build partnerships to speed up the momentum of vertical integration
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− Achieve critical mass workforce for in-house injectable plant facility
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Continue optimizing existing generic APIs
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Maintain the market share and profit of the top 5 marketed products
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Confidential
CRO Phase III Product Portfolio * Already Filed
| Code Est. NDA Filing Year Indication Region *Regional Sales Remarks Completed process validation |
Code Est. NDA Filing Year Indication Region *Regional Sales Remarks Completed process validation |
Code Est. NDA Filing Year Indication Region *Regional Sales Remarks Completed process validation |
Code Est. NDA Filing Year Indication Region *Regional Sales Remarks Completed process validation |
Code Est. NDA Filing Year Indication Region *Regional Sales Remarks Completed process validation |
Code Est. NDA Filing Year Indication Region *Regional Sales Remarks Completed process validation |
Code Est. NDA Filing Year Indication Region *Regional Sales Remarks Completed process validation |
Code Est. NDA Filing Year Indication Region *Regional Sales Remarks Completed process validation |
|---|---|---|---|---|---|---|---|
| **Code ** | Est. NDA Filing Year |
Indication | **Region ** | Regional* Sales** |
Remarks |
||
| Completed process validation | |||||||
| A | 2016* | Infectious Disease | US / EU / Asia |
$1.4 bn | . Anticipated launch in 2017 with demand in tons. Expected revenue of several million USDperyear |
||
| B | 2018 | Type I,II Diabetes |
US/ EU | $2.4 bn | Intermediate project made in Changshu site. Expected revenue of several million USD per year after launch |
||
| API project made in Changshu site CFDA | |||||||
| C | 2018 | Advanced Hepatocellular Carcinoma, Myelofibrosis, Autoimmune disease, etc. |
CN |
N/A | . granted accelerated review under its category 1.1 innovative drug. Anticipated launch in 2019 with demand intons |
||
| D | 2018 | Prostate Cancer | US / EU | $2.4 bn | Started process validation. Anticipated launch in 2019 and revenue of several million USD per year |
||
| Novel mechanism with promising demand. | |||||||
| E 2018 Parkinson’s Disease US $1.0 bn Anticipated launch in 2019 with demand in tons. Expected revenue of several million USDperyear |
E | 2018 | Parkinson’s Disease | US | $1.0 bn | Anticipated launch in 2019 with demand in tons. Expected revenue of several million USDperyear |
*** Source: BioMedTracker, GlobalData and DataMonitor**
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Confidential
China and Japan Market Development
China
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Accelerate progress to create positive cash flow
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Focus on mid- to late-phase CRO projects. Current portfolio includes agents for oncology, anti-hypertension, and diabetes
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Seek generic APIs/intermediates with large demand to increase production utilization
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� Develop partnerships with downstream formulation for collaborative development and registration, realizing shared profit creation
Japan
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Among 20 customers, 6 are top 10 drug firms. Less established players have exited the more concentrated market
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Encourage local generic customers to engage more in direct business
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Support Japanese companies and foreign pharmaceutical companies to enable and extend business outreach
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With the resources in Taiwan and Changshu, API supply is more flexible and can be incorporated to injectable drug product via integrated services
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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 API contract manufacturing in China for compliance.
-
The review and approval system significantly raises the cost structure & entry barrier in Chinese drug market, with dedication to quality and innovation.
-
We have domestic presence plus world-class strengths in:
-
Global, first-tier customer base
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High-technical-barrier oncology APIs
-
Quality and EHS/GMP compliance
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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 To 10 lobal harma CMO Aroved antideressant dru in US GMP Passed Mexican authorit (APIF) GMP |
||||||
| Customer | Project Type |
Product Indication/stage | Product Type |
Remarks/ Market | ||
| To 10 lobal harma | CMO | Aroved antideressant dru in US | GMP | Passed Mexican authorit (APIF) GMP |
||
| p g p | pp p g | Intermediate | y inspection |
|||
| Top 5 global pharma | CMO | Approved African sleeping disease drug | API | Site transfer from Taiwan |
||
| Lee’s Pharma | CRO / CMO |
>15 projects for brain tumors, antibiotic, hypertension, ophthalmology, 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 di |
API | US/China | ||
| egeneraton | ||||||
| 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 5globalpharma | CRO | Phase III clinical trial for diabetes | Intermediate | US | ||
| Top 5globalpharma | 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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Confidential
Formulation Business Progress
In-house injectable plant
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On schedule to complete equipment assembly and verification, sterility verification, organization, personnel deployment and training, and cGMP system deployment for both vial and cartridge production lines
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Planned kick-off registration batch production by 2017. Expected submission of 1st in-house ANDA in 2018 and subsequent US FDA inspection approval in 2019.
-
Formulation and collaboration development
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2 US ANDAs: Oncology product partnership with SAGENT, and ScinoPharmdeveloped Fondaparinux
-
16 co-developed and cost/profit sharing products with various partners
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Niche drugs planned with the indications of cancer, diabetes, osteoporosis and multiple sclerosis. Continue to develop strategic alliances, including ongoing discussions with international major companies for exclusive rights of distribution
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Injectable Plant
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Confidential
Aseptic Fill & Finish Service
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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 Oncology Myeloid 1st US ANDA filing, triggering US FDA inspection* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Oncology Myeloid 1st US ANDA filing, triggering US FDA inspection* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Oncology Myeloid 1st US ANDA filing, triggering US FDA inspection* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Oncology Myeloid 1st US ANDA filing, triggering US FDA inspection* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Oncology Myeloid 1st US ANDA filing, triggering US FDA inspection* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Oncology Myeloid 1st US ANDA filing, triggering US FDA inspection* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Oncology Myeloid 1st US ANDA filing, triggering US FDA inspection* |
Partner Product Indications Region Launch Year(E) Remarks Genovate Entecavir Hepatitis B Virus Taiwan 2013 1st co-developed formulation product launch Oncology Myeloid 1st US ANDA filing, triggering US FDA inspection* |
|---|---|---|---|---|---|---|---|
| Partner | Product |
Indications |
Region |
Launch Year(E) |
Remarks |
||
| Genovate | Entecavir | Hepatitis B Virus | Taiwan | 2013* | 1st co-developed formulation product launch | ||
| Oncology | Myeloid | 1st US ANDA filing, triggering US FDA inspection | |||||
| Sagent | Injectable |
Leukemia |
US | 2017 | in Changshu, China site |
||
| Foresee | Leuprolide | Prostate cancer | US | 2019 | 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 |
Fondaparinux | Anti-thrombotic | China | 2021 | Co-development collaboration | ||
| Pharma | Travoprost & Bimatoprost |
Glaucoma | China | 2021 | |||
| 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 | 2017 | US NDA 505(b)(2) / The estimated launch year is subject to US FDA review |
||
| US & China partners |
Project B | Imaging agent | US | 2021 | ANDA with Paragraph IV filing / The estimated launch year is subject to |
||
| litigation results Baxter 5 niche injectables Anti-cancer & antinauseant US/EU 2020& continuing thereafter Baxter has the right to add up to 15 additional injectable products for collaboration Indian Int’l partner Niche injectable Anti-thrombotic US/EU 2018 1st self-developed US ANDA launched. Executive right for marketing & sales 27 |
litigation results | ||||||
| Baxter | 5 niche injectables |
Anti-cancer & antinauseant |
US/EU | 2020& continuing thereafter |
Baxter has the right to add up to 15 additional injectable products for collaboration |
||
| Indian Int’l partner |
Niche injectable |
Anti-thrombotic | US/EU | 2018 | 1st self-developed US ANDA launched. Executive right for marketing & sales |
Confidential
Injectable Products Allied with Baxter
-
ScinoPharm and Baxter Healthcare establish worldwide partnerships to co-develop and commercialize five niche generic injectable products at the initial stage
-
ScinoPharm develops all APIs and injectable formulations. Baxter leads regulatory submissions in the US/EU and eventually market & sell the injectable products via its extensive presence in the hospital channel
-
Both parties work on a cost-and-profit-sharing collaboration model
-
Baxter has the right to add up to 15 additional injectable products for collaboration with ScinoPharm
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Confidential
Collaboration Framework
-
Initial product portfolio including the generic injectables for breast cancer, lung cancer, multiple myeloma and antinauseant. Targeting US/EU markets first and expect to expand to other territories
-
This exclusive partnership will utilize each other's strengths and expertise in order to achieve large scale of synergies in providing niche and affordable generic injectable products
-
Commercial launch for the first 5 products upon FDA approval, with product launches beginning in 2020 and continuing thereafter
-
Current branded sales of the initial five products included in this partnership total more than $4 billion annually
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Responsibilities by ScinoPharm and Baxter
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API Development
API Production
ScinoPharm
Formulation
Development
ScinoPharm
FDF Baxter
Manufacturing
CMO
Sales &
Baxter
Marketing
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FDF: Finished Dosage Form
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Confidential
Benefits of the Collaboration
-
Aggressively expanding our “Double A” strategy for inhouse developed/produced APIs and formulations. Providing an outlet for our injectable plant capacity
-
A win-win solution and collaboration. ScinoPharm provides comprehensive APIs and formulation portfolio, while Baxter operates strong injectable product marketing channels throughout the US and worldwide
-
Accelerate the momentum of our downstream integration strategy by establishing alliance with an world-renowned partner
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Confidential
Maintain Market Share of Existing APIs 2016 Major Products account for 65% of total sales
| API | Indication | 2016 MKT share* |
# of US DMF/EDMF & other filings |
||
| Irinotecan HCI |
Antineoplastic | 42% | 63 | ||
| Paclitaxel | Antineoplastic | 34% | 57 | ||
| Gemcitabine | Antineoplastic | 24% | 76 | ||
| Exemestane | Antineoplastic | 22% | 44 | ||
| Galantamine HBr | Antipsychotic | 17% | 38 | ||
| Docetaxel Anhydrous Antineoplastic 15% 69 *Source: IMS data from Newport 32 |
Docetaxel Anhydrous |
Antineoplastic | 15% | 69 | |
| *Source: IMS data from Newport |
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 |
||
| Generic API |
Desmopressin Acetate |
USA | Polyuria | Ferring | US$166M | US$405M | ||
| Generic API |
Tamsulosin HCl | USA | Benign Prostatic Hyperplasia (BPH) |
Boehringer Ingelheim |
US$333M | US$1706M | ||
| New Drug API |
Oncology Product |
US | Non-Small Cell Lung Cancer |
N/A | N/A | N/A | ||
| New Drug API |
Oral Product | USA EU |
Antibiotics | N/A | N/A | N/A | ||
| Generic Drug Oncology Injectable US Myeloid Leukemia MDS US$183M US$278M |
Generic Drug |
Oncology Injectable |
US | Myeloid Leukemia |
MDS | US$183M | US$278M |
Source: IMS Data (2015Q3-2016Q2)
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Pipeline Outlook
-
5-6 new launches
-
2 generic API launches
-
1 drug products launched in US
-
1[st] co-developed US ANDA � Chinese (CFDA) inspection at Changshu site
-
launched � US FDA inspection at Injectable plant
-
2017 2018 2019 2020
-
3-5 generic API launches
-
4-5 new launches
-
2 co-developed China ANDAs and 1 co-developed US ANDA launched
-
1[st ] in-house drug US ANDA filing
-
1[st] self-developed US ANDA launched
-
1 co-developed US ANDA launched
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Brand Quality with Asian Advantages www.scinopharm.com
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