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SPT — Interim / Quarterly Report 2017
Feb 23, 2018
51922_rns_2018-02-23_671d62dd-c3cb-4986-b743-c0dd1abc9f7c.pdf
Interim / Quarterly Report
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1789 TT
ScinoPharm Taiwan, Ltd. Fourth Quarter 2017 Investor Meeting
February 23, 2018
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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Table of Content
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Company Overview and Key Priorities
Operating Results
Business Highlights and Company Outlook
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Company Overview and Key Priorities
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ScinoPharm at a Glance
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ScinoPharm specializes in high potency (steroid/cytotoxic) APIs and injectable provider, serving customers worldwide
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Facility & offices established in Taiwan and expanding in China with a new GMP plant in Changshu & marketing base in Shanghai
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73 generic APIs in current portfolio with 25 APIs launched; 56 US DMFs filed (767 DMFs WW), 33 US DMFs in oncology APIs. 100+ NCE CRAM projects, with 6 NDAs launched and 4 in phase III
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Fully compliant with world-class cGMPs and international regulatory requirements; Certified by US FDA, EMA, EDQM, Australia TGA, Japan PMDA, Korea KFDA, Mexico COFEPRIS and Germany regulatory Authority
5
Driving Long Term Growth by Dual Profits
Self-Developed Products
Contract Services
- Target difficult-to-make (peptide)API in our portfolio
Tap into drug product related to our API core competencies
- Target 505(b)(2) and Paragraph IV drug product via strategic alliances
Provide CRO/CMO for APIs
Offer integrated service from API to formulation for niche injectables
- Provide biologics fill & finish CMO services
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World Class Facilities
Taiwan
China
API Plant
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5 of 16 production lines equipped with high potency capabilities for cytotoxic/steroid
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Provides comprehensive contract research & manufacturing services for brand drug companies
Injectable Plant
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Vial and cartridge production lines for oncological and peptide products
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To meet US, EU, Japan GMP standards with adopting state-of-the-art isolator technology and single use technology for product contact path
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API Plant
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3 of 7 production lines equipped with high potency capabilities for cytotoxic
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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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Strategic partnerships with China clients with downstream formulations and mutually target for global and China markets
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We Value Our R&D
- Strong focus on R&D with +125 experts (Ph.D:27)
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16%
84%
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R&D investments remain stable
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Strong API Portfolio for Generic Product
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36
40 unlaunched
35 launched
30
25 23
20
13
15
10 7 7 6
13 4
5 6 2 2 2 3
6
3
4
2 2 3
1 1
0
Note: Other (Women's Health, Gastrointestinal, Immunology and Metabolic)
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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 32 21
Shilpa 12 11 3
Polymed 10 2 3
MacChem Products 6 5 2 # Oncology DMF Overlap with SPT
Laurus Labs 8 7 16 # Non-overlapping Oncology DMF
# Other DMFs
Sichuan Xieli 1 2 1
Chemwerth 3 5 34
Apicore 5 8 27
0 10 20 30 40 50 60
Large Generic Pharmaceutical Companies
ScinoPharm 32 21
Teva 18 28 264
Dr. Reddy's 14 13 176
Cipla 11 17 128
Sun 17 12 164
Hisun 11 19 44
# Oncology DMF Overlap with SPT
Qilu 8 3 8
# Non-overlapping Oncology DMF
Hengrui 3 3 11 # Other DMFs
0 50 100 150 200 250 300
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Source: US FDA DMF Q2 2017 database
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Focus Drug Product Pipeline- on Complex Generics
| Indication | Format | Enter Barrier & Advantage |
|---|---|---|
| Osteoporosis | Pen | Complex Drug-Device Combination |
| Diabetes | Pen | Complex Drug-Device Combination |
| Anti-thrombotic | Syringe | Complex API |
| Multiple Sclerosis | Syringe | Complex API |
| Antineoplastic | Lyo | Difficult to make API and Formulation |
| Anti nauseant | Lyo | Difficult to make API and Formulation |
| Antineoplastic | Lyo,Vial | Difficult to make API |
| Antineoplastic | Lyo | Difficult to make API, Complex Route of Delivery and Formulation |
| Antineoplastic | Lyo | Difficult to make API |
| Antineoplastic | Lyo,Vial | Difficult to make API |
| Antineoplastic | Lyo,Vial | Difficult to make API and Formulation |
| Antineoplastic | Vial | ExistingAPI |
| Antineoplastic | Vial | ExistingAPI |
| Antineoplastic | Vial | ExistingAPI |
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Potential Headwinds & Tailwinds
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Headwind
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Tailwind
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Generic business continues facing negative pricing environment
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Increased consolidation among the
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US distribution supply chains More and faster ANDA approvals leading to quicker price erosion Fewer small molecule blockbuster drugs invented
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Impact of patent linkage and patent term extension in Taiwan
Pipeline of complex generics benefits from a faster approval cycle and higher margins
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CRAMs grow faster than the pharma
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Pharmerging markets are expected to grow due to increasing geriatric population and healthcare expenditure
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Focused Execution into 2018
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Expanding into formulation business by synergizing with our APIs - Complete the production of 4 registration batch drug products
- Establish partnership for self-developed drug products
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Strengthening Manufacturing and Quality
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Create leaner and flexible cost structures by improving operating efficiency, RD productivity and portfolio optimization
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Comply with the modern strict environmental laws in China
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Near term CRO projects pose to propel the company to next level - Focus on targeted therapies and orphan drugs /first in class or best in class - Provide integrated service from API to formulation for niche injectable
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Continuous process optimization on our existing APIs
- Maintain market share and profits of our major products
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Operating Results
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Quarterly P&L - Consolidated
| In NT$ million, except for EPS | Q4 2017 (Unaudited) |
Q3 2017 (Reviewed) |
QoQ | Q4 2016 (Audited) |
YoY | ||||||
| Revenue | 895 | 100% | 849 | 100% | 5% -24% |
1,002 | 100% | -11% 2% |
|||
| Cost of Goods Sold | (548) | -61% | (441) | -52% | (559) | -56% | |||||
| Gross Profit | 347 | 39% | 407 | 48% | -15% 3% |
444 | 44% | -22% -6% |
|||
| OperatingExpense | (247) | -28% | (256) | -30% | (234) | -23% | |||||
| Operating Income | 100 | 11% | 152 | 18% | -34% 10% |
210 | 21% | -53% -928% |
|||
| Non-operatingIncome,Net | (23) | -3% | (25) | -3% | 3 | 0% | |||||
| Income before Tax | 77 | 9% | 127 | 15% | -39% | 213 | 21% | -64% | |||
| Net Income | 61 | 7% | 107 | 13% | -43% | 147 | 15% | -59% | |||
| 0.08 | 0.14 | 0.19 | |||||||||
| EPS (NT$) | |||||||||||
| *Weighted average outstandingshares were 790.739m units in 4Q17. |
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Profit & Loss - Consolidated
| (note) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| In NT$ million, except for EPS | FY 2017 (Unaudited) |
FY 2016 (Audited) |
YoY | |||||||
| Revenue | 3,516 | 100% | 4,031 | 100% | -13% 12% |
|||||
| Cost of Goods Sold | (1,966) | -56% | (2,225) | -55% | ||||||
| Gross Profit | 1,550 | 44% | 1,806 | 45% | -14% -6% |
|||||
| OperatingExpense | (991) | -28% | (938) | -23% | ||||||
| Operating Income | 559 | 16% | 868 | 22% | -36% -45% |
|||||
| Non-operatingIncome,Net | (84) | -2% | (58) | -1% | ||||||
| Income before Tax | 475 | 14% | 811 | 20% | -41% | |||||
| Net Income | 422 | 12% | 659 | 16% | -36% | |||||
| 0.53 | 0.83 | |||||||||
| EPS (NT$) | ||||||||||
| EBITDA | 986 | 28% | 1,294 | 32% | -24% | |||||
| * Total outstandingshares were 790.739m units at 12/31/2017. |
Note: 2016 vs 2017: 5.96% NTD appreciation against USD YoY
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Profit & Loss (ScinoPharm stand-alone)
| (note) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| In NT$ million, except for EPS | FY 2017 (Unaudited) |
FY 2016 (Audited) |
YoY | |||||||
| Revenue | 3,449 | 100% | 3,889 | 100% | -11% 13% |
|||||
| Cost of Goods Sold | (1,778) | -52% | (2,041) | -52% | ||||||
| Gross Profit | 1,671 | 48% | 1,848 | 48% | -10% -11% |
|||||
| OperatingExpense | (870) | -25% | (782) | -20% | ||||||
| Operating Income | 801 | 23% | 1,066 | 27% | -25% -28% |
|||||
| Non-operatingIncome,Net | (313) | -9% | (244) | -6% | ||||||
| Income before Tax | 489 | 14% | 822 | 21% | -41% | |||||
| Net Income | 422 | 12% | 659 | 17% | -36% | |||||
| 0.53 | 0.83 | |||||||||
| EPS (NT$) | ||||||||||
| EBITDA | 823 | 24% | 1,178 | 30% | -30% | |||||
| * Total outstandingshares were 790.739m units at 12/31/2017. |
Note: 2016 vs 2017: 5.96% NTD appreciation against USD YoY
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Sales by Business
FY2017
FY2016
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Sales by Indications
FY2017
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FY2016
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Sales by Region
FY2017
FY2016
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Balance Sheet- Consolidated
| (In NT$ million) | 2017/12/31 (Unaudited) |
2016/12/31 (Audited) |
||||||
| Cash and Cash Equivalents | 3,911 567 1,675 391 5,089 1,068 |
31% 4% 13% 3% 40% 9% |
3,707 638 1,830 364 5,209 1,035 |
29% 5% 14% 3% 41% 8% |
||||
Accounts Receivable |
||||||||
| Inventories | ||||||||
| Long-Term Investments | ||||||||
| Property,Plant & Equipment | ||||||||
| Other Current/Non-Current Assets | ||||||||
| Total Assets | 12,701 | 100% | 12,783 | 100% | ||||
| Current Liabilities | 1,115 1,169 |
9% 9% |
1,692 863 |
13% 7% |
||||
| Long-Term & Other Liabilities | ||||||||
| Total Liabilities | 2,284 | 18% | 2,555 | 20% | ||||
| Total Shareholders' Equities Key Indices A/R Turnover (Days) Inventory Turnover (Days) Current Ratio (x) ROE (%) |
10,417 | 82% | 10,228 | 80% | ||||
| 65.6 434.5 5.8 4.1 |
71.6 405.6 3.9 6.6 |
|||||||
| A/R Turnover (Days) Inventory Turnover (Days) Current Ratio (x) ROE (%) |
||||||||
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Cash Flows- Consolidated
| (In NT$ million) | FY 2017 (Unaudited) |
FY 2016 (Audited) |
||||||
| From Operating Actavities | 972 | 1,665 | ||||||
| Profit before tax | 475 434 209 |
811 447 449 |
||||||
| Depreciation & Amortization | ||||||||
| Net change in workingcapital | ||||||||
| From Investing Actavities | (437) | (202) | ||||||
| Capital expenditure | (402) | (447) | ||||||
| From Financing Actavities | (314) | (138) | ||||||
| Short-term loans | (584) 518 (228) 204 |
(720) 803 (219) 1,371 |
||||||
| Long-term loans | ||||||||
| Cash dividends | ||||||||
| Net Change in Cash | ||||||||
| Beginning Balance | 3,707 | 2,336 | ||||||
| Ending Balance | 3,911 | 3,707 | ||||||
| Free Cash Flow | 570 | 1,218 | ||||||
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Business Highlights and Company Outlook
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Focusing on Weathering Near-Term Headwinds While Positioning for Long-Term Growth
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2017 2018 2019 and beyond
• Industry headwinds •
• Market conditions
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| • • • |
market conditions, leading to price erosion and volume decline Gained some, lost some in CRAM business China site still faced a financial loss Focused on cost reductions and portfolio |
• • • • |
expected to continue Sales from CRAM projects are expected to boost Speed up momentum of downstream integration strategy by establishing alliance with partner Aggressively expand formulation products Further cost reductions |
• • • |
expected to improve Continue investment in growth opportunities Maintain high level of quality and compliance Strong pipeline to drive growth from: - CRAM business - Drug products business |
|---|---|---|---|---|---|
| optimization | and portfolio optimization | ||||
| • | Accelerate progress to | ||||
| create positive cash flow | |||||
| for Changshu site |
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Developing dossiers per our high-entry-barrier APIs to increase value proposition in the supply chain
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Building a pipeline of complex and difficult to make generic injectable products
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Significant investment in injectable R&D in the next few years
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Quality driven, diversified manufacturing operations
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Promoting our formulations via strategic alliance, especially in China and US
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Acquiring critical resources via M&A
Expected > 15 drug product launched in the next 5 years
Introducing 3 to 4 drug products per year in our pipeline
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2018 In-House Injectable Plant Progress
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First Half
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Second Half
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Kick-off registration batch
production for other
products and offering CMO
services for both brand and
proprietary drugs
Expected submission of 1st
in-house produced ANDA
Taiwan FDA on-site
inspection
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- Already launched
Strate ic Alliance Hi hli hts g g g
| 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 | 2018 | 1st US ANDA filing, triggering US FDA inspection 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 |
| Lee’s Pharma |
Fondaparinux | Anti-thrombotic | China | 2022 | Co-development collaboration |
| Travoprost &Bimatoprost |
Glaucoma | China | 2022 | ||
| Nanjing King Friend |
Regadenoson | Stress agent for heart scan |
China | 2021 | Co-developed formulation in China |
| US partner | Project A | Non-small cell lung cancer |
US | 2018 | US NDA 505(b)(2) / 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 |
| 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 |
Fondaparinux | Anti-thrombotic | US/EU | 2018 | 1st self-developed US ANDA submitted . Executive right for marketing & sales |
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CRAM Business Gaining Momentum
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CRAM business is on track to regain growth momentum
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Sales from CMO will be boosted by Melinta's newly launched Baxdela™ , indicated for acute skin infections (ABSSSI), and other shipment by the CRO projects
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Baxdela™ , expected to become top 5 products in 2018, is designated as a qualified infectious disease product (QIDP)and enjoys a five-year extension of any non-patent exclusivity period
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More indications on the way for Baxdela™ include Serious Community-Acquired Bacterial Pneumonia (CABP) in Phase III and Complicated Urinary Tract Infections (CUTI) in Phase I
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Four CRO projects in Phase III trials are expected to file NDAs in 2018/2019 and if successful could result in the drugs being launched in 2019/2020 with incremental sales
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CRO Phase III Products Portfolio
| NDA Filing Year(E) |
Indication |
Region | Remarks |
|---|---|---|---|
| 2018 | Type I,II Diabetes |
US/ EU | Intermediate project made both in Changshu & Taiwan sites. Expected revenue of several million USD per year after launch |
| 2018 | Advanced Hepatocellular Carcinoma, Myelofibrosis, Autoimmune disease |
CN | API project made in Changshu site. CFDA granted accelerated review under its category 1.1 innovative drug. Anticipated launch in 2019 with demand in tons |
| 2018 | Prostate Cancer | US / EU | Started process validation. Anticipated launch in 2019 and revenue of several million USD per year |
| 2019 | Familial Adenomatous Polysis |
US / EU | API project made both in Taiwan & Changshu sites. Anticipated launch in 2020 with demand in tons to tens tons |
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China Market Dynamics
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China has paved the way for integration with global standard and move up to key positions in value chain, requiring dedication to quality and innovation
-
Tightened GMP, Environment/Health/Safety laws and drug
-
license approval process significantly raise the cost structure Full Market Authorization Holder (MAH) rolled out creating a sizable demand in high-quality CDMO services Reduction of application backlog and review timeline acceleration for NDA and China+US dual-track drug filing
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ScinoPharm Changeshu - Capturing Chinese Growth on Multiple Fronts
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Position as a gateway into China providing supplychain to MNCs
Adopt dual-track drug filing process in China and the US
Seek generic APIs or intermediates with large demand to increase production utilization
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Focus on mid- to late-phase CRO projects. Current portfolio includes agents for oncology, anti-hypertension, and diabetes
Tighten cost control and process optimization with enhanced management
As the back up site for generic API after the Implementation of patent term extension
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Maintain Market Share of Existing APIs - 2017 Major Products account for 50 % of total sales
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| API Product Indication MKT share # of US DMF/EDMF & other filings Irinotecan HCI Antineoplastic 37% 64 Exemestane Antineoplastic 25% 46 Paclitaxel Antineoplastic 21% 60 Gemcitabine Antineoplastic 17% 76 Docetaxel Anhydrous Antineoplastic 15% 72* |
API Product Indication MKT share # of US DMF/EDMF & other filings Irinotecan HCI Antineoplastic 37% 64 Exemestane Antineoplastic 25% 46 Paclitaxel Antineoplastic 21% 60 Gemcitabine Antineoplastic 17% 76 Docetaxel Anhydrous Antineoplastic 15% 72* |
API Product Indication MKT share # of US DMF/EDMF & other filings Irinotecan HCI Antineoplastic 37% 64 Exemestane Antineoplastic 25% 46 Paclitaxel Antineoplastic 21% 60 Gemcitabine Antineoplastic 17% 76 Docetaxel Anhydrous Antineoplastic 15% 72* |
API Product Indication MKT share # of US DMF/EDMF & other filings Irinotecan HCI Antineoplastic 37% 64 Exemestane Antineoplastic 25% 46 Paclitaxel Antineoplastic 21% 60 Gemcitabine Antineoplastic 17% 76 Docetaxel Anhydrous Antineoplastic 15% 72* |
|---|---|---|---|
| API Product | Indication | MKT share* | # of US DMF/EDMF & other filings |
| Irinotecan HCI | Antineoplastic | 37% | 64 |
| Exemestane | Antineoplastic | 25% | 46 |
| Paclitaxel | Antineoplastic | 21% | 60 |
| Gemcitabine | Antineoplastic | 17% | 76 |
| Docetaxel Anhydrous |
Antineoplastic | 15% | 72 |
*Source: IMS data from Newport
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2018 Product Launch Plan
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| Type | Product | Region | Indication | Brand Marketer |
Regional Sales |
WW Sales |
|---|---|---|---|---|---|---|
| Generic API |
Tamsulosin HCl |
CN | Benign Prostatic Hyperplasia (BPH) |
Boehringer Ingelheim |
US$97MM | US$1,652.8MM |
| Generic API |
Flumazenil | JP | Reversal of Conscious Sedation and General Anesthesia |
Roche | US$13.5MM | US$76.1MM |
| Generic API |
Capecitabine | JP | Antineoplastic | Roche | US$122MM | US$834.7MM |
| Generic Drug |
Oncology Injectable |
US | Myeloid Leukemia |
MDS | US$175.9MM | US$284.4MM |
| Generic Drug |
Fondaparinux | US | Anti-thrombotic | Mylan | US$75.1MM | US$194.9MM |
Source: IMS Data (2016Q3-2017Q2)
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Pipeline Outlook Timeline
-
3 generic APIs launched
-
5-7 generic APIs launched
-
3 in-house drug ANDAs filed
- 2 co-developed China ANDAs
-
1[st] BD & 1[st ] self-developed US ANDA launched 3 APIs by CRAM customers launched
-
3 NDAs filed by CRAM customers 2018 2019 2020 2021
- 3 APIs by CRAM customers launched
-
5-7 generic APIs launched
-
1 BD US ANDA launched
-
3 APIs by CRAM customers launched
-
US FDA inspection at Injectable plant
-
CFDA inspection at Changshu site
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6-8 generic APIs launched
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3 BD & 1 self-developed ANDA launched
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5 APIs by CRAM customers launched
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Four Key Pillars to Achieve Strategic Roadmap
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BUILD
strong pipelines of complex drug
products / APIs and expand
geographic presence
CONTINUE
to drive transformation and
operational excellence through
leadership, people and culture
FOSTER
partnership and collaboration to
increase value and capture untapped
opportunity
FOCUS
long term value creation for our
shareholders
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Brand Quality with Asian Advantages
www.scinopharm.com
1789 TT
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