ScinoPharm Taiwan, Ltd. · TWSE:1789
ScinoPharm Taiwan — Investor Presentation (August 2012)
35 slides from ScinoPharm Taiwan's investor presentation, Aug 23, 2012
Slide 1: ScinoPharm Management Presentation
ScinoPharm Management Presentation TWSE 1789 August 23, 2012 1
Slide 2: Disclaimer
Confidential 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 cont
Slide 3: Table of Content
Confidential Table of Content Overview of ScinoPharm Financial & Operation Results Obesity Drug Market Injectable Plant Project Business Outlook 3
Slide 4: Overview of ScinoPharm
Overview of ScinoPharm - An Active Pharmaceutical Ingredient Company ScinoPharm has become the first Biotech/Pharma company to enter the “Top 100 valuable companies by market cap in TWSE”, now ranking at #86 4
Slide 5: Company Overview
Confidential Company Overview Maintain dominant position in Specialty APIs for generic market. Established strong presence in US/EU generic market, some channeled through Indian generic companies. Aggressively developing Japanese and Chinese markets Developed more than 50 generic APIs with 17 launch
Slide 6: ScinoPharm Changshu complies with latest Chinese GMP
ScinoPharm Changshu complies with latest Chinese GMP 6
Slide 7: ScinoPharm Changshu Phase I QC Lab
ScinoPharm Changshu Phase I QC Lab High Standard Clean Room Microbe Incubator 7
Slide 8: Recent developments in SPT & SPC
Confidential Recent developments in SPT & SPC SPT’s Bay 4, 5 will start pilot production and IQ/OQ by the end of Q3 and will start full production by the year-end of 2012 SPC’s phase I production facilities have obtained pilot production permits from local authorities SPC’s phase I small and mid pro
Slide 9: ScinoPharm - Oncological API Leader
Confidential ScinoPharm - Oncological API Leader 9
Slide 10: Financial & Operation Results
Financial & Operation Results 10
Slide 11: P&L - Consolidated
Confidential P&L - Consolidated 1H, 2012 1H, 2011 NT$MM, except EPS (audited) (audited) YoY Net Sales 1,884 1,760 7% Gross Profit 961 883 9% Gross margin 51% 50% Operating Expense (478) (390) 22% Operating Income 483 493 -2% Operating margin 26% 28% Other Rev.(Exp.) 7 (19) 40% Net Income after Tax 4
Slide 12: Balance Sheet- Consolidated
Confidential Balance Sheet- Consolidated NT$MM 2012/06/30 2011/06/30 (audited) (audited) Cash and Cash Equivalents 2,972 30% 2,009 26% Accounts Receivable 732 7% 684 9% Inventories 2,022 21% 1,404 19% Long-Term Investments 150 2% 206 3% Fixed Assets 3,475 35% 2,942 38% Other Assets 472 5% 379 5% Tot
Slide 13: Cash Flows- Consolidated
Confidential Cash Flows- Consolidated 1H, 2012 1H, 2011 NT$MM (audited) (audited) Cash and cash equivalents at 3,294 1,908 beginning of period Cash flows from operating activities 96 407 CAPEX (383) (277) Other Investing activities 35 29 Cash flows from financing activities - - Cash and cash equival
Slide 14: Sales by Business
Confidential Sales by Business 2011 H1 2012 H1 CMO CMO 11% 5% CRO CRO 2% 3% Generic Generic 86% 93% 14
Slide 15: Sales by Indications
Sales by Indications 2011 H1 2012 H1 Others 12% Others 11% Oncology CNS Oncolog 64% 13% y75% CNS 25% 15
Slide 16: Obesity Drug Market
Obesity Drug Market 16
Slide 17: What is Obesity?
What is Obesity? Body Mass Index (BMI) – a simple index of weight-for-height that is used to classify overweight and obesity in adults (by WHO) How to calculate your BMI? BMI (Kg/m2) = WHO Definition – Overweight, BMI ≥ 25; Obesity, BMI ≥ 30 TFDA Definition – Overweight, BMI 24~27; Obesity, BMI > 27
Slide 18: BMI Calculation
BMI Calculation Weight (kg) Height (cm) 40 50 60 70 80 90 100 150 18 22 27 31 36 40 44 155 17 21 25 29 33 37 42 160 16 20 23 27 31 35 39 165 15 18 22 26 29 33 37 170 14 17 21 24 28 31 35 175 13 16 20 23 26 29 33 180 12 15 19 22 25 28 31 TFDA Definition – Overweight, BMI 24~27; Obesity, BMI > 27 18
Slide 19: Obesity
Confidential Obesity According to TFDA, 1.8 million people in Taiwan are obese and 3.5 million people are overweight. In 2010, 35.7% (>78m) of US adults are obese; this is expected to reach 42% in 2030 Obesity increases premature death by 40% and is associated with increased risk for – Coronary hear
Slide 20: Anti-Obesity Market Has High Unmet Needs
Confidential Anti-Obesity Market Has High Unmet Needs Withdrawal of Sanofi-Aventis’ Acomplia (rimonabant) in 2008 Rimonabant is associated with increased risk of psychiatric side effects Withdrawal of Abbott’s Meridia (sibutramine) in 2010 Sibutramine is associated with increased risk of serious car
Slide 21: Qsymia vs. Belviq
Confidential Qsymia™ vs. Belviq® Qsymia™ (topiramate + phentermine) Belviq® (lorcaserin HCl) Approval July 2012 June 2012 Commercialization 2012Q4 2013Q1~Q2 Efficacy Placebo adjusted weight loss= 7.5- 9.4% Placebo adjusted weight loss= 3.1- 3.6% Safety Fetal developmental abnormalities Animal carcin
Slide 22: ScinoPharm Will Be the Supplier of Topiramate for Vivus' Qsymia
Confidential ScinoPharm Will Be the Supplier of Topiramate for Vivus’ Qsymia™ Vivus’ oral anti-obesity drug, Qsymia™, was approved by the FDA on July 17th Qsymia™ is forecasted to achieve a market value of US$1- 1.2bn within the next 5 years ScinoPharm is the only supplier of topiramate for Vivus’ Q
Slide 23: Anti-Obesity Pipeline Late in Line for Competition
Confidential Anti-Obesity Pipeline Late in Line for Competition Orexigen’s oral combination pill, Contrave (bupropion + naltrexone), faces a prolonged regulatory hurdle Pre-approval cardio-vascular outcomes trial (CVOT) is required – expected approval is in 2014 Placebo adjusted weight loss= 3.2- 5.
Slide 24: Injectable Plant Project
Injectable Plant Project 24
Slide 25: Injectable forms: vial, prefilled syringe, lyophilized powder, ampoule
Liquid Solution in Vial Lyophilized Powder in Vial Prefilled-Syringe Ampoule 25
Slide 26: Difficulties in building and running oncological injectable plant
Difficulties in building and running oncological injectable plant With the stricter international CGMP standards in recent years, many injectable plants received warning letters and were required to stop production. Injectable CMOs are in undersupply condition, especially in oncological injectables
Slide 27: Background for ScinoPharm to build an Injectable Plant
Background for ScinoPharm to build an Injectable Plant ScinoPharm has been the leader in providing oncological APIs to regulated markets worldwide Most customers lack the capabilities of producing oncological injectables and are mostly outsourcing their production to CMOs Existing US and EU injectab
Slide 28: Shortage of Injectable CMO capacities
Shortage of Injectable CMO capacities Non-Onco Location Company Oncological Oncological Prefilled Liquid Vial Lyoph. Vial Syringe Australia Hospira v*** v*** v*** Canada Uman Pharma v*** v*** v*** BioPharma Germany Solutions v v v Business Business Business USA Ben Venue suspended suspended suspende
Slide 29: Business Opportunities of ScinoPharm's Injectable plant
Business Opportunities of ScinoPharm’s Injectable plant Customers own ANDA Customers own ANDA and ask ScinoPharm to be their CMO to make APIs into various injectables (such as liquid vial, lyophilized vial, etc.) At present, WW injectable capacities are in tight condition (pls see above page). Many
Slide 30: Business Opportunities of ScinoPharm's Injectable plant
Business Opportunities of ScinoPharm’s Injectable plant ScinoPharm owns ANDA ScinoPharm can develop formulations using its own oncological APIs or using others’ APIs, and apply for the formulation ANDA with FDA. It can then utilize its own injectable plant to make into all kinds of injectables (incl
Slide 31: Details of Injectable Plant
Details of Injectable Plant Total CAPEX estimated at about US$ 37.6 million (equivalent to about NT$ 1.1 billion) The plant will be built in Tainan, with complete international GMP compliant facilities, including R&D, QA, cleaning, sterilized, production, filling, lyophilized, packaging, and warehou
Slide 32: Business Outlook
Business Outlook 32
Slide 33: 2012 Product Launch Plan
2012 Product Launch Plan Regional WW Sales API Region Indications Brand Marketer Sales Antithrombotic, $US $US Argatroban US GSK Anticoagulant 139MM* 205MM* Galantamine Alzheimer’s $US $US EU Janssen HBr disease 314MM* 527MM* $US $US Modafinil US Antinarcolepsy Cephalon 1,078MM* 1,182MM* Riluzole $U
Slide 34: Outlook
Confidential Outlook Sustain Leadership Position in Oncological Injectable APIs Continue developing small molecule oncological injectable APIs and expand into other areas with high technology barriers including Peptides Expand Presences in China Expansion of API business to timely capture the Chines
Slide 35: Brand Quality with Asian Advantages
Confidential Brand Quality with Asian Advantages www.scinopharm.com 35
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