Asia (Singapore) as a Medtech Hub: Case Study of Biosensors

Transcription

1 Asia (Singapore) as a Medtech Hub: Case Study of Biosensors Biosensors International Group, Ltd. SGX: B20 Yoh Chie, Lu Chairman & Founder Biosensors International Group

2 Forward Looking Statements Certain statements herein include forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of Forward-looking statements generally can be identified by the use of forward-looking terminology, such as may, will, expect, intend, estimate, anticipate, believe, project or continue or the negative thereof or other similar words. All forward-looking statements involve risks and uncertainties, including, but not limited to, customer acceptance and market share gains, competition from companies that have greater financial resources; introduction of new products into the marketplace by competitors; successful product development; dependence on significant customers; the ability to recruit and retain quality employees as Biosensors grows; and economic and political conditions globally. Actual results may differ materially from those discussed in, or implied by, the forward-looking statements. The forward-looking statements speak only as of the date of this release and Biosensors assumes no duty to update them to reflect new, changing or unanticipated events or circumstances. 2

3 World Population (2013) 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1, , ,140 India China China India Asia (includes China & India) 58% of World Population ,118 Europe US World Source: World Population Statistics 3

4 (US$ Trillion) World GDP (2012) China India Asia (includes China & India) 29% of World GDP Europe US World Source: Compiled from IMF s World Economic Outlook Database (October 2013) 4

5 FDI Net Inflows (2012) (US$ Billion) $1.20 $1.00 $0.80 $0.60 $ % of World FDI Net Inflows $0.20 $- China Asia (includes China) Europe US World FDI = Foreign Direct Investment Source: Compiled from The World Bank s Databank in November

6 People Annual new graduates in the field of science & engineering by region Source: India, Data Monitor, Oct 2011; Morgan Stanley 6

7 Asia as world manufacturing hub Main reasons: Low cost Good quality Good service Government support 7

8 Proposition Hence: If leading-edge technology could be developed in Asia Asia can certainly be a medtech hub Discuss using Biosensors as a case study

9 CASE STUDY OF BIOSENSORS

10 Milestones Company founded Listed on SGX Acquired 50% of BI China BioMatrix: CE Mark; Launched in Asia & EMEA 2008 BioMatrix Flex: CE Mark; Launched in Asia & EMEA 2010 Acquired remaining 50% of BI China *EMEA = Europe, Middle East & Africa 10

11 Biosensors Series of Firsts First: biodegradable polymer with a Limus drug drug specifically designed for use in DES abluminal coating automated pipette coating DES Clinical trial program to demonstrate safety and efficacy in all-comers population (simultaneous publication) head-to-head all-comers randomized trial compared to SES and to achieve primary endpoint CE mark approved bifurcated DES company with DES on a guide wire Sparrow

12 Business Segments Products Key Approvals Regions Selling In Critical Care Blood pressure transducers Thermodilution catheters Embolectomy catheters Central venous catheters FDA, CE Mark, SFDA, MHLW Worldwide Interventional Cardiology Drug-Eluting Stents Bare Metal Stents PCTA Balloon Catheters FDA, CE Mark, SFDA, MHLW* Worldwide except for U.S. Cardiac Diagnostics D-SPECT Cardiac Imaging System FDA, CE Mark, MHLW Mainly U.S. 12

13 Products Key Approvals Regions Selling In Interventional Cardiology 1. Drug-Eluting Stents 2. Bare Metal Stents 3. PCTA Balloon Catheters FDA, CE Mark, SFDA, MHLW* Worldwide except for U.S

14 EN Rev.01 Unique DES Technology BIOLIMUS A9 (BA9) DRUG Biosensors proprietary rapamycin derivative Highest lipophilicity of the common limus drugs ABLUMINAL COATING Early BMS-like endothelial coverage More targeted tissue release Less systemic exposure BIODEGRADABLE PLA POLYMER Simultaneous PLA biodegradation and BA9 elution No PLA /BA9 coating on the stent after 6 to 9months +/- 2.8% (valid for all drugs tested) 14

15 Our Landmark LEADERS Study: Clinical-Based Evidence Compared BioMatrix Flex against Cypher Select from Johnson & Johnson, in a real-world, all-comers patient population Lower Risk of MACE 1 74% Reduction in Very Late ST 2 1 MACE: Major Adverse Cardiac Events (includes heart attack and heart-related deaths) 2 ST: Stent Thrombosis (blood clot that forms on the stent) * P-value for superiority 15

16 Continuously Innovating for Patient BioFreedom is a polymer-free drug-coated coronary stent Received CE Mark approval in January 2013 Benefit May offer benefit of a drug-eluting stent with reduced duration of dualantiplatelet therapy Being investigated in LEADERS FREE study which is currently enrolling 16

17 How we lead the pack Company Commercialized DES Biodegradable Polymer Proprietary Drug BioMatrix Flex Biosensors Boston Scientific Medtronic Abbott BioMatrix Axxess Excel SYNERGY Promus Element TAXUS Element Resolute Integrity Endeavor Resolute ABSORB Xience Xience Prime 17

18 USD Mil Historical Performance FY09 FY10 FY11 FY12 FY13 Total revenue Net profit excl extraordinary items

19 The peripheral vascular device market covers noncoronary applications $6+ billion WW market size Peripheral Biosensors will leverage its technology and target 2 key arteries of the leg: SFA Superficial Femoral Artery SFA (Superficial Femoral Artery) BTK (Below the Knee) BTK Below the Knee 19

20 Peripheral Products BIOPATH Expected Product Approval DRUG ELUTING BALLOON 3 rd Qtr 2013 BELOW THE KNEE BALLOON 1 st Qtr 2014 PERIPHERAL BELOW THE KNEE DES 1 st Qtr 2014 BILLIARY STENT 3 rd Qtr 2014

21 Products Key Approvals Regions Selling In Cardiac Diagnostics D-SPECT Cardiac Imaging System FDA, CE Mark, MHLW Mainly U.S. D-SPECT is a cardiology-dedicated NM imaging system used by leading medical centers around the world D-SPECT aims to select the right patients for percutaneous coronary intervention (PCI) and guide their invasive treatment by evaluating cardiac conditions, such as coronary perfusion, heart muscle viability and heart failure 21

22 Expanding into Adjacencies, Deriving Synergies Cardiology Cardiac Diagnostics Spectrum Dynamics Technology Biosensors DES Technology + Agreement with Eurocor for drugeluting balloons Peripheral Intervention 22

23 US$25 Billion Total Market Size Peripheral 6b Nuclear Imaging 12b DES 4.5b CCP 2.5b DES CCP Nuclear Imaging Peripheral

24 Conclusion Using TECHNOLOGIES developed inhouse, BIG achieved big results despite being outside US M&A and R&D to drive towards vision of US$1 billion annual revenue Conclusion: Asia has all prerequisites to become a future medtech hub

25 Thank you! Q&A