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SPT — Investor Presentation 2015
May 11, 2015
51922_rns_2015-05-11_a582369e-ec36-4a2d-9308-c499595a4f5f.pdf
Investor Presentation
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TWSE 1789
ScinoPharm Management Presentation
First Quarter 2015 On-Line Investor Meeting
May 8, 2015
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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� Overview of ScinoPharm
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Financial & Operating Results in Q1, 2015
-
Market Trend Update
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Overview of ScinoPharm
- An API + ANDA Company Active Pharmaceutical Ingredients Abbreviated New D rug Application
34
Confidential
Business Overview
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Established in 1997 in Taiwan and listed on TWSE in 2011, current market cap around US$1.2 billion
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Specializes in high potency (steroid/cytotoxic) APIs and expands to injectable formulations
-
Facility & organization built in Taiwan and expanding in China with a new GMP plant in Changshu & marketing base in Shanghai
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70 generic APIs developed with 27 APIs launched; 50 US DMFs filed (703 DMFs WW), 24 US DMFs in oncological APIs. 80+ NCE CRAM projects, with 5 launched and 9 in phase III for NDA filing in 2-3 years
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Full compliance to world class quality and regulatory practices; Successfully passed US FDA, EMA, Australian TGA, Japanese PMDA inspections
4
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
-
:
-
Innovative Delivery Formulations Targeted delivery & extended release of proven APIs via 505(b)2 fast track
-
:
-
Brand New Chemical Entities (New Drugs) Collaborating with academic research institutes, focusing on un-met oncological medical needs of high prevalence in Asia
5
Keys to Generic Formulation Business
-
Expanding formulation portfolio
-
Building on-site oncological injectable facility and establishing a complete supply chain of oral products
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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
6
Passed the 5th US FDA GMP Inspection
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Zero 483 observation on 18 products sold to the US
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US FDA newly adopted “Quality Metrics Initiative”, for each production site to provide "quality level“ data; FDA can check how well the quality system maintained and how successfully the system affects the quality of the medicinal products
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� Focus on the Rates of Lot Acceptance, Right First Time, Product Quality Complaint, Management Engagement, etc.
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More emphasis on initial selection criteria and evaluation of suppliers and ways to deal with quality and compliance issues in a timely manner
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An FDA Form 483 is issued to the management of a production site at the conclusion of an inspection when an investigator has observed any conditions that in his/their judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts.
7
Top Warning Letter Citations
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Inadequate design & construction features
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Inadequate control of microbiological contamination
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Data integrity
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Inadequate raw material testing
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Inadequate special training requirement
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Inadequate stability testing
ScinoPharm successfully passed FDA audits on these key quality matters
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| More Tightened cGMP Requirement Company Warning Letter Issue Date |
More Tightened cGMP Requirement Company Warning Letter Issue Date |
More Tightened cGMP Requirement Company Warning Letter Issue Date |
More Tightened cGMP Requirement Company Warning Letter Issue Date |
|---|---|---|---|
| Company | Warning Letter Issue Date | ||
| Hospira S.p.A. | 03/31/2015 | ||
| Hospira Australia | 09/26/2014 | ||
| GSK Biologicals | 06/12/2014 | ||
| Sun Pharmaceutical | 05/07/2014 | ||
| Johnson & Johnson International | 06/06/2013 | ||
| Teva Neuroscience | 04/08/2013 | ||
| Hospira Healthcare India | 05/28/2013 | ||
| Boehringer Ingelheim Pharma | 05/06/2013 | ||
| Genentech | 10/03/2012 | ||
| Eli Lilly | 08/10/2012 | ||
Pfizer 06/19/2012 Watson 06/07/2012 |
|||
| Pfizer | 06/19/2012 | ||
| Watson | 06/07/2012 |
Source : US FDA Website
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GMP Compliance as Competitive Advantage
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To handle the stringent cGMP requirements, many pharmas face severe challenges, leading to either outsource production or shut down product lines
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Due to CAPEX concern, many old pharmas hesitate to upgrade facility and staff training, which creates huge demands for high quality contract research & manufacturing services
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� With FDA inspected facilities in all scales and effective quality management systems, ScinoPharm offers world class quality services to brand name and generic customers in a flexible, reliable, and competitive approach
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Financial & Operating Results
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Quarterly P&L - Consolidated
| In NT$ million, except for EPS 1Q 2015 (Reviewed) 1Q 2014 (Reviewed) YoY |
In NT$ million, except for EPS 1Q 2015 (Reviewed) 1Q 2014 (Reviewed) YoY |
In NT$ million, except for EPS 1Q 2015 (Reviewed) 1Q 2014 (Reviewed) YoY |
In NT$ million, except for EPS 1Q 2015 (Reviewed) 1Q 2014 (Reviewed) YoY |
In NT$ million, except for EPS 1Q 2015 (Reviewed) 1Q 2014 (Reviewed) YoY |
In NT$ million, except for EPS 1Q 2015 (Reviewed) 1Q 2014 (Reviewed) YoY |
|---|---|---|---|---|---|
| In NT$ million, except for EPS | 1Q 2015 (Reviewed) |
1Q 2014 (Reviewed) |
YoY | ||
| Net Sales | 979 | 1,097 | -11% | ||
| Gross Profit | 344 | 433 | -21% | ||
| Gross margin | 35% | 39% | |||
| Operating Expenses | (203) | (250) | -19% | ||
| Operating Income | 141 | 183 | -23% | ||
| Operating margin | 14% | 17% | |||
| Other Rev.(Exp.) | (7) | 2 | -450% | ||
| Net Income before Tax | 134 | 185 | -28% | ||
| Net Income after Tax 113 165 -32% Net margin after tax 12% 15% EPS (after tax) 0.16 0.24 -33% 12 |
Net Income after Tax | 113 | 165 | -32% | |
| Net margin after tax | 12% | 15% | |||
| EPS (after tax) | 0.16 | 0.24 | -33% |
Balance Sheet- Consolidated
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2015/3/31 2014/3/31
In NT$ million
(Reviewed) (Reviewed)
Cash and Cash Equivalents 2,008 17% 2,793 23%
Accounts Receivable 653 6% 630 5%
Inventories 2,402 21% 2,637 22%
Long-Term Investments 244 2% 260 2%
Property, plant & equipment 5,109 44% 4,434 37%
Other assets 1,155 10% 1,275 11%
Total Assets 11,571 100% 12,029 100%
Current Liabilities 2,004 17% 2,156 18%
-
L-T Liabilities and Others 91 1% 66
Stockholders’ Equities 9,476 82% 9,807 82%
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Cash Flows- Consolidated
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1Q 2015 1Q 2014
In NT$ million
(Reviewed) (Reviewed)
Cash and cash equivalents at
1,928 2,289
beginning of period
Cash flows from operating activities 241 492
CAPEX (269) (372)
Short-term borrowings 86 380
Others 22 4
Cash and cash equivalents at
2,008 2,793
end of period
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Sales by Business
2015 Q1
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CMO BD
CRO
2014 Q1 9% 2% 2%
CRO
CMO
Generics
5%
20%
87%
Generics
75%
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Sales by Indications
2015 Q1
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Others
CNS
8%
2014 Q1 12%
Others
16% Oncology
80%
CNS Oncology
24% 60%
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Sales by Region
2015 Q1
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Rest of
AU+NZ
Asia ROW
4%
2014 Q1 12% <1%
Rest of
AU+NZ ROW India
US+CAN
Asia
1% <1% 22%
40%
8% India
8% EU
22%
EU US+CAN
27% 56%
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Market Trend Update
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Oncology as Global Top 1 Therapy
| 2013 | 2013 | 2013 | 2020 WW Sales CAGR% Growth (2013-2020) |
2020 WW Sales CAGR% Growth (2013-2020) |
2020 WW Sales CAGR% Growth (2013-2020) |
|
|---|---|---|---|---|---|---|
| $72.8bn $44.9bn $33.7bn $32.6bn $27.8bn $38.4bn |
+11.2% +8.7% +3.5% +7.3% +7.1% +1.4% $153.1bn $68.9bn $45.6bn $41.3bn $35.9bn $57.1bn |
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| $ $68.9bn $45.6bn $41.3bn $35.9bn $57.1bn |
||||||
| $25.6bn $17.5bn $16.2bn $14.6bn $19.3bn $14.1bn $13.5bn |
$28.2bn $21.8bn $19.2bn $17.8bn $26.1bn $17.7bn $16.4bn |
+7.1% -3.6% +4.3% +5.1% +10.4% +2.8% +5.7% |
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| 0% 5% 10% 15% WW Market Share (%) 0% 5% 10% 15% WW Market Share (%) +9.4% -5.5% $13.1bn $11.1bn $14.8bn $13.0bn |
$13.1bn $11.1bn |
$14.8bn $13.0bn |
Source: Evaluate Pharma
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Global Oncology Value Soaring
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Oncology has become the top 1 therapy area since 2013
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Global cancer drug spending reached $100 Billion in 2014 per IMS Health
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Oncology will keep growing to $153.1 Billion in 2020 per Evaluate Pharma
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CAGR in global cancer drug spending jumped to 6.5% during the past 5 years and projected to be 8% in 2018, per IMS Health
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ScinoPharm’s oncology emphasis echoes the global therapy trend
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Oncology as US FDA Approval Focus
� Approved in oncology more than in other therapies
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45 22%
Oncology non-Oncology 31%
40
9
35
23%
12
30 27%
19%
8% 7
25
5 10%
2
7
20 2
32
15
27
36%
23
22
10 21 19 19
4
5
7
0
2008 2009 2010 2011 2012 2013 2014 2015
Number of approved drugs
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Note: *: as of 2015/4/20 ** The number of oncology products is not including radioactive drugs Source: US FDA Website
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Small Molecules Still Oncology Mainstream
� Oncology biologics increasing
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Oncology_Small Molecule
12
Oncology_Biologics
10
8
9
5
6
4
5
4
4
3
2 4
3 3
2 2 2
1 1
0
2008 2009 2010 2011 2012 2013 2014 2015
Note: * as of 2015/4/20 Source: US FDA Website
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Number of approved oncology drugs
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Targeted & Immuno-therapies Flying
� Chemo- and hormonal therapies declined
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Chemotherapy
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Targeted therapy
12 Immunotherapy
1
Supportive care
10
Hormonal therapy
8
9 5
6
4
1
4 6
1 3
2 4 4
1 1 1
2
1 1 1 1 1
0
2008 2009 2010 2011 2012 2013 2014 2015
Note: * as of 2015/4/20 Source: US FDA Website
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Number of approved oncology drugs
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Targeted Therapy Dominates Oncology
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Supportive care
1%
Protein
Kinase
Immunotherapy Inhibitor
23%
Targeted
60%
therapy
Hormonal
60%
therapy
14% mAb
20%
ADC 11%
Chemotherapy
Others 9%
2%
Source: 2020 Sales Forecast, Global Data
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ScinoPharm Pipeline Echoes Therapy Trend
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Supportive
Genito Urinary System Hematological care 5%
& Sex Hormones 2% Ophthalmology 2% disorder 2%
Respiratory 4%
Gastrointestinal
Hormonal
5%
therapy
21%
Infectious Targeted
disease 8% Oncology therapy
36% 74%
Cadiovascular 8%
Immunology
10%
Metabolic
CNS
disorder 13%
10%
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2015 Product Launch Plan
| API | Region | Indications | Brand Marketer |
Regional Sales | WW Sales |
|---|---|---|---|---|---|
| Azacitidine | US | MDS Oncology | Celgene | US$323MM* | US$815MM* |
| Benazepril | CN | Hypertension, CV |
Novartis | US$65MM** | US$480MM* |
| Desmopressin | US | Polyuria | Ferring | US$131MM* | US$395MM* |
| Letrozole | JP | Breast Cancer | Novartis | US$51MM** | US$581MM* |
| Tamsulosin | US | Benign prostatic hyperplasia (BPH) |
Boehringer Ingelheim |
US$335MM* | US$1,829MM* |
Source: * IMS Data (2013Q3-2014Q2) ** In-house research
Launched
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uestions Q
&
Answers
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Brand Quality with Asian Advantages www.scinopharm.com
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