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SPT — Investor Presentation 2014
Mar 11, 2014
51922_rns_2014-03-11_6ba4ec16-af72-4fbe-a0fd-874020dc526e.pdf
Investor Presentation
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ScinoPharm Management Presentation
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TWSE 1789
February 14, 2014
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Disclaimer
This material has been prepared by ScinoPharm Taiwan, Ltd. (“ScinoPharm”).
Any opinions expressed in this material are subject to change without notice as a result of using different assumptions. ScinoPharm is under no obligation to update or keep current the information contained herein. The information contained in this presentation is ScinoPharm’s confidential information.
Any disclosure, copying, distribution or any action taken or omitted to be taken in reliance on it is prohibited and may be unlawful.
No representation or warranty , express or implied, is or will be made in or in relation to, and no responsibility or liability is or will be accepted by the Company as to , the accuracy or completeness of this material and any liability therefore is hereby expressly disclaimed.
Statements made in this material include forward-looking statements, which include, without limitation, statements about the issues, plans and expectations of ScinoPharm. Without limiting the foregoing, statements including the words “believes”, “anticipates”, “plans”, “expects” and similar expressions are also forward-looking statements. Forward-looking statements reflect, among other things, management’s plans and objectives for future operations, current views with respect to future events and future economic performances and projections of various financial items. These forwardlooking 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
Overview of ScinoPharm Financial & Operating Results SPC Phase II Opening Video China Operations Update Business Outlook
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Overview of ScinoPharm - An API + ANDA Company
Active Pharmaceutical Ingredients Abbreviated New Drug Application
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Background
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Established in 1997 in Taiwan by founders from Syntex, listed on TWSE, current market cap ~ US$ 2.0 billion
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Major shareholders include Uni-President Group, Government’s Development Fund, Taiwan Sugar, etc.
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Facility & organization designed & built in Taiwan by experienced Syntex team, received multiple regulatory inspections from US FDA, Australia, EU, Japan, etc.
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Specializes in high potency (steroid, cytotoxic) & injectable APIs
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Expanding in China with a new plant in Changshu & sales/marketing base in Shanghai
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Business Overview
Maintain dominant position in Specialty APIs for generic market. Strong customer base (320+) in US/EU/Japan, some through Indian generics. Aggressively developing Japan and China markets
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Developed ~70 generic APIs with 23 launched. Filed 47 DMFs in US (663 DMFs WW), leader in supplying oncology injectable APIs with 22 US DMFs
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80+ NCE CRAMs projects, with 6 in phase III for NDA filing in 2-3 years & 5 projects already launched. The only company in Asia supplying APIs for multiple commercial NCEs
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ScinoPharm - Oncological API Leader
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Source: FDA 2013Q4 DMF database
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World Class Facilities
Taiwan (SPT)
China (SPC)
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6.6 hectares of land, 330K sq. ft. facilities with >200M[3] reactor volume
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8 of 18 production lines equipped with high potency capabilities for cytotoxics or steroids
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US FDA approved & 200+ GMP audits by customers
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Provides full CRAMs for brand drugs
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Building an oncological injectable plant
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Global market
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6.6 hectares of land with ~250M[3] reactor volume
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2 of 8 production lines equipped with high potency capabilities for cytotoxics
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CGMP designed facility for intermediates & high potency API
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Full scope capabilities in developing and manufacturing APIs from small to large scale for generic & CRAM markets
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Global market including China
Common Stren th g
Differentiators
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Same sizable land area
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Taiwan Complied with int’l GMP & EHS vs standards for global market
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China Strong R&D capabilities
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Plant Multi-functional plants, able to produce high potency APIs
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Small, mid, to large lines
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Different reactor chamber volumes (200M[3 ] in SPT vs. 250M[3 ] in SPC)
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SPC mainly for large volume
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SPT focusing on global export; SPC on China domestic market
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SPT with an injectable plant
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Financial & Operating Results
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Cumulative P&L - Consolidated
| In NT$ million, except for EPS | 1Q~4Q,’13 (Unaudited) |
1Q~4Q,’12 (Audited) |
YoY |
|---|---|---|---|
| Net Sales | 5,088 | 4,573 | 11% |
| Gross Profit | 2,543 | 2,313 | 10% |
| Gross margin | 50% | 51% | |
| Operating Expenses | (1,145) | (1,053) | 9% |
| Operating Income | 1,398 | 1,260 | 11% |
| Operating margin | 27% | 28% | |
| Other Rev.(Exp.) | 11 | 112 | -90% |
| Net Income before Tax | 1,409 | 1,372 | 3% |
| Net Income after Tax | 1,273 | 1,171 | 9% |
| Net margin after tax | 25% | 26% | |
| EPS (after tax) | 1.88 | 1.73 | 9% |
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Balance Sheet- Consolidated
| In NT$ million | 2013/12/31 (Unaudited) |
2013/12/31 (Unaudited) |
2012/12/31 (Audited) |
2012/12/31 (Audited) |
|---|---|---|---|---|
| Cash and Cash Equivalents | 2,289 | 20% | 3,035 | 29% |
| Accounts Receivable | 971 | 8% | 841 | 8% |
| Inventories | 2,512 | 22% | 1,870 | 18% |
| Long-Term Investments | 258 | 2% | 168 | 2% |
| Fixed Assets | 4,214 | 37% | 3,559 | 34% |
| Total Assets | 11,484 | 100% | 10,340 | 100% |
| Current Liabilities | 1,775 | 15% | 1,204 | 12% |
| L-T Liabilities and Others | 66 | 1% | 65 | -% |
| Stockholders’ Equities | 9,643 | 84% | 9,071 | 88% |
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Cash Flows- Consolidated
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1Q~4Q 2013 1Q~4Q 2012
In NT$ million
(Unaudited) (Audited)
Cash and cash equivalents at
3,035 3,294
be innin of eriod
g g p
Cash flows from operating activities 945 980
CAPEX (1,225) (873)
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Long-term Investment (107)
Short-term borrowings 426 264
Cash Dividends (780) (631)
Others (5) 1
Cash and cash equivalents at
2,289 3,035
end of eriod
p
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Sales by Business
FY2012
FY2013
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CRO
2%
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CMO
28%
Generic
72%
CRO
<1%
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Sales by Indications
FY2012
FY2013
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Others
Others
4%
11%
CNS
CNS Oncology
Oncology
39% 50% 39% 57%
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Sales by Region
FY2012 FY2013
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Rest of AU & NZ ROW
Rest of AU & NZ ROW
Asia 5% <1%
Asia 5% 0%
12%
7%
India India
10% 12%
US & CAN
US & CAN
52%
51%
EU
EU
27%
19%
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China Operations Update
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Key Progress for China Market
ScinoPharm
Changshu
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Obtained drug production permits for 4 APIs (3 for anti-cancer and 1for anti-viral)
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Submitted 1 drug license application for an anti-cancer API
ScinoPharm Taiwan
- Submitted drug import license application for 9 APIs (5 for anti-cancer, 2 for cardiovascular disease, 1 for Alzheimer's disease, and 1 for benign prostatic hyperplasia)
Strateigic Alliance
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Formulation development of Bortezomib began in June 2013; Stability batches expected to be completed in Feb. 2014
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Formulation development of Azacitidine to start in early 2014
SPC passed CRAM customer audits
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ASLAN Pharmaceuticals and a multinational pharmaceutical company have been jointly developing an oncology compound
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ScinoPharm Changshu has undertaken the API CRAM Services for this project and successfully passed the GMP audit by this customer
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This targeted delivery drug is entering into clinical trial phase II, focused on solid tumor treatment, including breast cancer
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prostate cancer and
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Global patient population of these two cancers is currently ~3.5MM and 6MM, respectively, while the market value is expected to reach US$6.5Bn by 2020 and US$18.7Bn by 2022
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Summary of SPC’s CRAMS projects
| Product code | Customer | Indications | Type | Stage |
|---|---|---|---|---|
| CN02-M006 | Lee’s Pharma | Ovarian Cancer | API | Phase III |
| CN02-M002 | Customer T | Gastric disease | API | Phase II |
| CN02-R006 | Aslan JV | Prostate cancer, Breast caner |
API | Phase II |
| CN02-M005 | Customer I | AIDS prevention | API | Phase II |
| CN02-M007 | Customer Z | Liver cancer | API | Phase II |
| CN02-M001 | Forest Lab | Depression | Intermediate | Commercial |
| CN02-G026 | Vivus | Obesity | API | Commercial |
| CN02-G030 | Customer S | Antinarcolepsy | API | Commercial |
*** All above items are audited by CRAM customers, commercial sales of APIs need FDA approvals**
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Business Outlook
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2014 Product Launch Plan
| API | Region | Indications | Brand Marketer |
Regional Sales | WW Sales |
|---|---|---|---|---|---|
| Azacitidine | US | MDS, Anti-cancer |
Celgene | US$365MM* | US$792 MM* |
| Dantrolene (injectable) |
US | Malignant hyperthermia |
JHP Pharma- ceuticals |
US$22 MM* | US$50 MM* |
| Decitabine | US | MDS, AML Anti-cancer |
Eisai | US$254 MM* | US$278 MM* |
| Docetaxel trihydrate |
JP | Anti-cancer | Sanofi Aventis | US$180 MM (Taxotere)** |
US$1,570 MM* |
| Entecavir | TW | Hepatitis B virus | BMS | US$67 MM*** | US$1,344 MM* |
| Riluzole (liquid) |
EU | Amyotrophic lateral sclerosis |
Sanofi Aventis | US$56 MM* | US$227 MM* |
| Zoledronic acid |
JP | Osteoporosis | Novartis | US$120 MM*** | US$1,755 MM* |
Source: * Newport/IMS Data (Jul2012-Jun2013) Datamonitor *In-house research
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Outlook
Sustain Leadership in Oncological APIs Continue to launch and develop oncological injectable APIs & others with high technological barriers including Peptides Establish Presences in China Develop APIs and formulations to timely capture the generic business with strategic alliance and CRAMs from MNCs
Japanese Market Penetration Expand strategic partnerships with major pharma
Vertical Integration – API+ANDA Select difficult-to-make APIs to formulate dossiers and build an oncology injectable plant to provide value-added total solution to customers
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Confidential
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Brand Quality with Asian Advantages
www.scinopharm.com
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