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SPT — Investor Presentation 2014
Sep 30, 2014
51922_rns_2014-09-30_ef1438c3-942a-4c81-aaef-af93267fb7d5.pdf
Investor Presentation
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ScinoPharm Management Presentation
TWSE 1789
August 7, 2014
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 cause actual results to differ from those such may materially implied by forward-looking statements.
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Table of Content
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Overview of ScinoPharm
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Financial & Operating Results
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First US ANDA filing allied with SAGENT
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Product Launch Table
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Q&A
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Overview of ScinoPharm - An API + ANDA Company
Active Pharmaceutical Ingredients Abbreviated N ew Drug Application
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Background
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Established in 1997 in Taiwan by founders from Syntex, listed in 2011, current market cap around US$1.6Bn
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Major shareholders include Uni-President Group, National 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), peptide, & injectable APIs
� Expanding in China with a new plant in Changshu & sales & marketing base in Shanghai
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Business Overview
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ScinoPharm has established its leading position in Oncology APIs and is integrating into formulation; running two GMP compliant facilities in Taiwan & China, and building an injectable plant in Taiwan
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Developed 70+ generic APIs with 26 launched. Filed 47 DMFs in US (674 DMFs WW), a leader in 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 already launched. The only company in Asia supplying APIs for multiple commercial NCEs
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Long Term Strategies
Transforming to a full-scope pharma company per our core competency of R&D and cGMP manufacturing in high-technical barrier APIs
� : Vertical Integration to Generic Formulations Developing dossiers per our difficult-to-make APIs to increase value proposition in the supply chain
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Innovative Delivery Formulations: Targeted delivery & extended release of proven APIs via 505(b)2 fast track
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:
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Brand New Chemical Entities (New Drugs) Collaborating with academic research institutes, focusing on unmet oncological medical needs of high prevalence in Asia
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Keys to Generic Formulation Biz
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Expanding formulation portfolio:
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Injectable (oncology & non-oncology): 11 drugs planned
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� Oral (oncology & non-oncology): 10 drugs planned � Ophthalmic: 3 drugs planned
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To be launched in 2016 through 2024
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Building on-site oncological injectable facility and establishing a complete supply chain
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Sustaining B2B model, promoting our formulations via strategic alliance, especially in China and US
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Acquiring critical resources via M&A
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Financial & Operating Results
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Quarterly P&L - Consolidated
| In NT$ million, except for EPS 2Q,’14 (Reviewed) 1Q,’14 (Reviewed) 2Q,’13 (Reviewed) QoQ YoY |
In NT$ million, except for EPS 2Q,’14 (Reviewed) 1Q,’14 (Reviewed) 2Q,’13 (Reviewed) QoQ YoY |
In NT$ million, except for EPS 2Q,’14 (Reviewed) 1Q,’14 (Reviewed) 2Q,’13 (Reviewed) QoQ YoY |
In NT$ million, except for EPS 2Q,’14 (Reviewed) 1Q,’14 (Reviewed) 2Q,’13 (Reviewed) QoQ YoY |
In NT$ million, except for EPS 2Q,’14 (Reviewed) 1Q,’14 (Reviewed) 2Q,’13 (Reviewed) QoQ YoY |
In NT$ million, except for EPS 2Q,’14 (Reviewed) 1Q,’14 (Reviewed) 2Q,’13 (Reviewed) QoQ YoY |
In NT$ million, except for EPS 2Q,’14 (Reviewed) 1Q,’14 (Reviewed) 2Q,’13 (Reviewed) QoQ YoY |
In NT$ million, except for EPS 2Q,’14 (Reviewed) 1Q,’14 (Reviewed) 2Q,’13 (Reviewed) QoQ YoY |
|---|---|---|---|---|---|---|---|
| In NT$ million, except for EPS | 2Q,’14 (Reviewed) |
1Q,’14 (Reviewed) |
2Q,’13 (Reviewed) |
QoQ | YoY | ||
| Net Sales | 1,148 | 1,097 | 1,339 | 5% | -14% | ||
| Gross Profit | 500 | 433 | 724 | 15% | -31% | ||
| Gross margin | 44% | 40% | 54% | ||||
| Operating Expenses | (287) | (250) | (267) | 15% | 7% | ||
| Operating Income | 213 | 183 | 457 | 16% | -53% | ||
| Operating margin | 19% | 17% | 34% | ||||
| Other Rev.(Exp.) | (1) | 2 | 11 | -107% | -102% | ||
| Net Income before Tax | 212 | 185 | 468 | 15% | -55% | ||
| Net Income after Tax 193 165 406 16% -53% Net margin after tax 17% 15% 30% EPS (after tax) 0.28 0.24 0.60 17% -53% |
Net Income after Tax | 193 | 165 | 406 | 16% | -53% | |
| Net margin after tax | 17% | 15% | 30% | ||||
| EPS (after tax) | 0.28 | 0.24 | 0.60 | 17% | -53% |
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Half Year P&L - Consolidated
| In NT$ million, except for EPS 1H,’14 (Reviewed) 1H,’13 (Reviewed) YoY |
In NT$ million, except for EPS 1H,’14 (Reviewed) 1H,’13 (Reviewed) YoY |
In NT$ million, except for EPS 1H,’14 (Reviewed) 1H,’13 (Reviewed) YoY |
In NT$ million, except for EPS 1H,’14 (Reviewed) 1H,’13 (Reviewed) YoY |
In NT$ million, except for EPS 1H,’14 (Reviewed) 1H,’13 (Reviewed) YoY |
In NT$ million, except for EPS 1H,’14 (Reviewed) 1H,’13 (Reviewed) YoY |
|---|---|---|---|---|---|
| In NT$ million, except for EPS | 1H,’14 (Reviewed) |
1H,’13 (Reviewed) |
YoY | ||
| Net Sales | 2,245 | 2,524 | -11% | ||
| Gross Profit | 933 | 1,379 | -32% | ||
| Gross margin | 42% | 55% | |||
| Operating Expenses | (538) | (534) | 1% | ||
| Operating Income | 395 | 845 | -53% | ||
| Operating margin | 18% | 33% | |||
| Other Rev.(Exp.) | 2 | 30 | -92% | ||
| Net Income before Tax | 397 | 875 | -55% | ||
| Net Income after Tax | 358 | 756 | -53% | ||
| Net margin after tax | 16% | 30% | |||
| EPS (after tax) | 0.53 | 1.12 | -53% |
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Balance Sheet - Consolidated
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2014/6/30 2013/6/30
In NT$ million
(Reviewed) (Reviewed)
Cash and Cash Equivalents 2,184 18% 3,379 29%
Accounts Receivable 793 7% 870 7%
Inventories 2,676 23% 2,288 20%
Long-Term Investments 255 2% 273 2%
Fixed Assets 4,658 40% 3,897 33%
Total Assets 11,795 100% 11,702 100%
Current Liabilities 2,569 22% 2,527 22%
L-T Liabilities and Others 66 -% 66 -%
Stockholders’ Equities 9,160 78% 9,109 78%
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Cash Flows - Consolidated
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1H 2014 1H 2013
In NT$ million
(Reviewed) (Reviewed)
Cash and cash equivalents at
2,289 3,035
beginning of period
Cash flows from operating activities 248 457
CAPEX (694) (506)
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Long-term investment (107)
Short-term borrowings 317 491
Others 24 9
Cash and cash equivalents at
2,184 3,379
end of period
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Sales by Business
1H 2013
1H 2014
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CRO
>1%
CMO
30%
Generic
70%
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CRO
3%
CMO
20%
Generic
77%
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Sales by Indications
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1H 2014
1H 2013
Others Others
5% 16%
CNS
CNS
36% Oncology 19% Oncology
59% 65%
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Sales by Region
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1H 2013
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1H 2014
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Rest of AU & NZ ROW Rest of AU & NZ ROW
Asia 4% <1% Asia 4% <1%
14% 9%
India
India
13%
12%
US & CAN
US & CAN
50%
EU EU 49%
20% 25%
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First US ANDA Filing Allied with Sagent
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Background on Sagent
▪ Sagent Pharmaceuticals (Nasdaq: SGNT), ScinoPharm’s long term customer, is a leading specialty pharma emphasizing on the injectable. Sagent has well-developed marketing channels into hospitals throughout the US
▪ Sagent’s China facility -- Sagent (Chengdu) is one of the few US FDA-qualified injectable plants in China. The company has also produced the first batch of oncological injectable products approved for direct export from China to the US
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Collaboration in Oncological Product
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ScinoPharm and Sagent have jointly developed and produced an oncological injectable product used for the treatment of myeloid leukemia
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Its market value exceeded US$280 million in 2013 WW, while US$250 million from the US
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ANDA has been submitted to the US FDA, which will help trigger FDA to audit ScinoPharm’s Changshu site (SPC) and enable SPC’s volume API shipments into the US regulated market
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Commercial launch upon US FDA approval, expected as early as late 2016
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Collaboration Scheme
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ScinoPharm Taiwan developed the API and lyophilized formulation processes
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ScinoPharm Changshu produces the API
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Sagent’s China affiliate in Chengdu prepares the injectable formulation
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Sagent leads filing the ANDA with the US FDA and eventually marketing this drug after launch
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Collaboration Flow Chart
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Successfully
developed API and
formulation
Outsourcing
ScinoPharm formulation
Taiwan
US
Sagent
Sagent
Outsourcing US Market
China
Injectables
API API
Sales/
Formulation
Marketing
OEM
ScinoPharm in the US
Changshu
File ANDA
API OEM
US FDA
on-site audit
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2014 Product Launch Plan
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2014 Product Launch Plan
| API | Region | Indications | Brand Marketer | Regional Sales | WW Sales |
|---|---|---|---|---|---|
| Azacitidine | US | MDS, Anti-cancer |
Celgene | US$358MM* | US$818MM* |
| Dantrolene (injectable) |
US | Malignant hyperthermia |
JHP Pharmaceuticals |
US$20MM* | US$46MM* |
| Decitabine | US | MDS, AML Anti-cancer |
Eisai | US$250MM* | US$289MM* |
| Docetaxel trihydrate |
JP | Anti-cancer | Sanofi Aventis | US$180MM (Taxotere)** |
US$1,422MM* |
| Entecavir | TW | Hepatitis B virus | BMS | US$67MM*** | US$1,413MM* |
| Exemestane | US | Breast cancer | Pfizer | US$99.5MM* | US$300.1MM* |
| Riluzole (liquid) |
EU | Amyotrophic lateral sclerosis |
Sanofi Aventis | US$66MM* | US$187MM* |
| Zoledronic acid | JP | Osteoporosis | Novartis | US$120MM*** | US$1,361MM* |
Source: * IMS Data (Year 2013)
Launched
* Datamonitor In-house research**
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Confidential
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Brand Quality with Asian Advantages
www.scinopharm.com
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