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SPT — Investor Presentation 2015
Feb 3, 2015
51922_rns_2015-02-03_7b968e2c-d5dc-4617-bbfb-899b50909ee0.pdf
Investor Presentation
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ScinoPharm Management Presentation
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TWSE 1789
February 3, 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
Overview of ScinoPharm
Financial & Operating Results in Q4, 2014
Progress Made in China
Business Updates
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Overview of ScinoPharm
- An API + ANDA Company
Active Pharmaceutical Ingredients Abbreviated New D A rug pplication
3 4
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
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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 (694 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; The Qualified Asian supplier to provide APIs to global market for multiple commercial NCEs
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Strong Generics Product Portfolio
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ScinoPharm - Oncological API Leader
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Diversified CRAM Portfolio
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| Stage | MFG Site | First Launch Year | Indication | Location |
|---|---|---|---|---|
| Commercial | SPT | 2005 | Eluting Stent | US |
| Commercial | SPT | 2009/2013 | Skin Infection/HAP | US/EU |
| Commercial | SPT | 2011 | Depression | US |
| Commercial | SPT | 2012 | Obesity | US |
| **Commercial ** | SPT | 2013 | Seizure | US |
| Stage | MFG Site | Est. NDA Filing Year | Indication | Location |
| Phase III | SPT | 2014* | Infections | US |
| Phase III | SPT | 2016 | Prostate & Ovarian Cancer | EU |
| Phase III | SPT | 2016 | Prostate Cancer | US |
| Phase III | SPT | 2017 | Seizure | US |
| Phase III | SPT | 2017 | Parkinson’s Disease | US |
| Phase III | SPT | 2017 | Opioid-Induced Constipation | US |
| Phase III | SPC | 2016-2017 | Ovarian Cancer | CN |
| Phase III | SPC | 2016 | Hypogonadism | US |
| Phase III | SPC | 2017 | Cancer | CN |
*** Filed**
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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
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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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Brand New Chemical Entities (New Drugs): Collaborating with academic research institutes, focusing on un-met oncological medical needs of high prevalence in Asia
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Keys to Generic Formulation Business
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Expanding formulation portfolio
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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
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Strategic Alliances
*** Already launched**
| Partner | Product | Indications | Region | Launch Year(E) |
Remarks |
|---|---|---|---|---|---|
| Genovate | Entecavir | Hepatitis B Viral | TW*/ CN |
2013*/ 2019 |
1st co-developed formulation product launch |
| Sagent | Oncological Injectable |
Myeloid Leukemia |
US | 2017 | 1st US ANDA filing to trigger US FDA inspection in Changshu site |
| Foresee | Leuprolide | Prostate cancer | US | 2018 | 505(b)2 NDA CRAM + Equity |
| Coland | Bortezomib | Multiple Myeloma |
CN | 2018 | 1st co-developed drug in China to trigger CFDA inspection in Changshu |
| Azacitidine | MDS | CN | 2019 | Co-developed formulation | |
| Lee’s Pharma |
Fondaparinux | Anti-thrombotic | CN | 2019 | Co-developed formulation |
| Travoprost Bimatoprost |
Glaucoma | CN | 2020 | Co-developed formulation | |
| Nanjing King Friend |
Regadenoson | Stress agent for heart scan |
CN | 2020 | 1st type 3.1 co-developed new drug in China |
Pipeline Outlook
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4-5 new launches 8-10 new launches 6-8 new launches
US FDA inspection on SPC 1 [st] co-developed drug 1 [st] type 3.1 co-developed
product launched in China new drug launched in
China
US FDA inspection on INJ
2015 2016 2017 2018 2019 2020
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4-5 new launches 5-6 new launches 7-9 new launches
1 [st ] CRAM service of
1 [st] ANDA product
type 1.1 new drug
launched in US
launched in China
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Financial & Operating Results
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Cumulative P&L - Consolidated
| In NT$ million, except for EPS | 1Q~4Q,’14 (Unaudited) |
1Q~4Q,’13 (Audited) |
YoY |
|---|---|---|---|
| Net Sales | 4,098 | 5,088 | -19% |
| Gross Profit | 1,600 | 2,543 | -37% |
| Gross margin | 39% | 50% | |
| Operating Expenses | (1,041) | (1,145) | -9% |
| Operating Income | 559 | 1,398 | -60% |
| Operating margin | 14% | 27% | |
| Other Rev.(Exp.) | 43 | 11 | 291% |
| Net Income before Tax | 602 | 1,409 | -57% |
| Net Income after Tax | 484 | 1,273 | -62% |
| Net margin after tax | 12% | 25% | |
| EPS (after tax) | 0.69 | 1.81 | -62% |
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Balance Sheet- Consolidated
| In NT$ million | 2014/12/31 (Unaudited) |
2014/12/31 (Unaudited) |
2013/12/31 (Audited) |
2013/12/31 (Audited) |
|---|---|---|---|---|
| Cash and Cash Equivalents | 1,928 | 17% | 2,289 | 20% |
| Accounts Receivable | 523 | 5% | 971 | 8% |
| Inventories | 2,449 | 22% | 2,512 | 22% |
| Long-Term Investments | 248 | 2% | 258 | 2% |
| Property, plant and equipment | 5,065 | 44% | 4,214 | 37% |
| Others | 1,159 | 10% | 1,240 | 11% |
| Total Assets | 11,372 | 100% | 11,484 | 100% |
| Current Liabilities | 1,918 | 17% | 1,775 | 15% |
| L-T Liabilities and Others | 74 | 1% | 66 | 1% |
| Stockholders’ Equities | 9,380 | 82% | 9,643 | 84% |
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Cash Flows- Consolidated
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1Q~4Q 2014 1Q~4Q 2014
In NT$ million
(Unaudited) (Audited)
Cash and cash equivalents at
2,289 3,035
beginning of period
Cash flows from operating activities 888 939
CAPEX (1,018) (1,226)
Long-term Investment 0 (107)
Short-term borrowings 588 426
Cash Dividends (811) (780)
Others (8) 2
Cash and cash equivalents at
1,928 2,289
end of period
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Sales by Business
FY2014
CRO+BD
<1%
FY2013
CRO < 1%
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CMO
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Sales by Indications
FY2014
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Others
11%
FY2013
CNS
Others
Oncology
27%
4%
62%
CNS
Oncology
39%
57%
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Sales by Region
FY2014
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Rest of
AU&NZ
Asia ROW
2%
11% <1%
India
15%
US&CAN
EU
42%
30%
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FY2013
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India
15%
AU&NZ ROW
Rest of 5% <1%
Asia
12%
India
US&CAN
12%
52%
EU
19%
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Progress Made in China
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Confidential
Golden Opportunities in China
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Government’s 12[th] five-year plan encourages pharma industry to grow at a CAGR of 20%
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Tighten GMP requirements to align with US/EU
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Motivate drug makers to improve quality by applying for US ANDAs, which need SPT’s world class APIs
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MNCs and emerging virtual-model players create huge needs in API contract manufacturing in China for compliance
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ScinoPharm timely captures oncological API needs via importing from Taiwan and local made in Changshu sites
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Portfolio Fits China’s Demands
| Rank | Therapeutic indication |
2012 China Market Share |
# of SP’s API candidates |
|---|---|---|---|
| 1 | Anti-cancer | 18.9% | 31 |
| 2 | Anti infective | 15.3% | 5 |
| 3 | Cardiovascular | 14.5% | 7 |
| 4 | Metabolic | 14.1% | 5 |
| 5 | Blood & Blood-Forming | 11.8% | 0 |
| 6 | CNS | 10.9% | 9 |
Source: Blue Book on 6 major drugs of Chinese pharmaceutical industry , 2013
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Confidential
Provide 6 of Top 10 Oncological Drugs
| Rank | Drug | 2012 Sales* |
% of market |
% of growth | SP’s Pipeline |
|---|---|---|---|---|---|
| 1 | Paclitaxel | 1144 | 9.15% | 19.01% | V |
| 2 | Docetaxel | 1049 | 8.39% | 7.81% | V |
| 3 | Pemetrexed | 688 | 5.50% | 44.32% | V |
| 4 | Oxaliplatin | 662 | 5.30% | 5.51% | |
| 5 | Kangai | 570 | 4.56% | 31.94% | |
| 6 | Capecitabine | 568 | 4.54% | 15.45% | V |
| 7 | Rituximab | 535 | 4.28% | 18.69% | |
| 8 | Gemcitabine | 454 | 3.69% | 6.51% | V |
| 9 | Tegafur | 446 | 3.57% | 87.77% | V |
| 10 | Herceptin | 387 | 3.09% | 17.31% |
*** Unit: RMB Million Source: Analysis Report of Anti-Cancer Drugs, 2014**
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Confidential
Key Progress for China Market
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ScinoPharm
Taiwan
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Submitted drug import license applications for 10 APIs (5 for anti-cancer, 2 for cardiovascular, 1 for Alzheimer's disease, 1 for benign prostatic hyperplasia and 1 for Hepatitis B )
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ScinoPharm
Changshu
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• Obtained drug production permits for 9 APIs (6 for anti-cancer, 1 for anti-viral and 2 for glaucoma ) • Submitted 2 drug license applications for anticancer APIs
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Strategic
Alliance
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5 formulation development and 1 new drug projects smoothly undergoing. Expected to be commercially available in 2018-2020
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Business Updates
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Injectable Plant Progress
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To be completed by Q2’15 and start registration batch production for liquid vial line by Q4’15. Expected to submit the 1[st] home-made ANDA in 2017 and pass US FDA inspection in 2018
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Target on biologics, high potent new drugs and smallvolume, complicated and high unit-priced generics
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Offer CMO services for brand drugs and self-developed drug products in the initial stage
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Flexible in capacity expansion and capable for producing liquid/lyophilized vials and prefilled syringes
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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 |
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uestions Q
&
Answers
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Brand Quality with Asian Advantages www.scinopharm.com
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