Biosensors International Group. 28 th Annual J.P. Morgan Healthcare Conference January 2010

Transcription

1 Biosensors International Group 28 th Annual J.P. Morgan Healthcare Conference January 2010

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 forwardlooking 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.

3 Overview of Biosensors Founded in 1990 Public since 2005 (Singapore exchange b20.si) Interventional cardiology and critical care product lines interventional cardiology represents primary business Global presence - USA, Switzerland, The Netherlands, China, India, Indonesia, Japan and Singapore Significant restructuring over the past 15 months Switzerland The Netherlands Tokyo, Japan Weihai, China Newport Beach, USA India Singapore

4 Transforming Biosensors Technology into Shareholder Value Restructure Operations Focused DES R&D Pipeline Strong Clinical Data 10% OUS DES Market Share Strengthen Asia Position

5 Biosensors Recent Changes and Restructuring BioMatrix launched April 2008; approvals obtained all over the world Terumo contract restructured (excluding Japan) US operations restructured 60 employee reduction; facility consolidation Netherlands manufacturing operation (Occam) closed 45 employee reduction; product lines discontinued IVP manufacturing operations consolidated into new Singapore-based facility Key functions consolidated globalization of critical responsibilities R&D focus fewer projects; USA on hold; pursue BioFreedom as long-term strategic platform Refinancing completed US $45.0 MM in convertible debt retired; new debt issued

6 Boston Scientific (BSX) Statement December 2008 Finally, we acquired Labcoat Ltd. in Q4. Labcoat has developed a novel technology for coating drug-eluting stents that uses precisely metered droplets of a biodegradable polymer and drug formulation to create a thin coating confined to the outer surface of the coronary stent. This proprietary technology is designed to significantly reduce the amount of polymer and drug to which the vessel is exposed, by eliminating the polymer and the drug on the inner surface of the stent, where endothelial cell growth is required for healing. Once the drug has been delivered, the biodegradable coating resorbs, leaving behind only the bare metal stent. This approach is intended to provide the same degree of restenosis reduction as a conventional drugeluting stent with faster and more complete vessel healing after stent implantation. We intend to apply this technology to our next generation platforms, which we believe will set a new standard for DES performance and be a key ingredient to continuing our worldwide DES leadership. Jim Tobin, Former CEO of Boston Scientific

7 Boston Scientific (BSX) Statement December 2008 Finally, we acquired Labcoat Ltd. in Q4. Labcoat has developed a novel technology for coating drug-eluting stents that uses precisely metered droplets of a biodegradable polymer and drug formulation to create a thin coating confined to the outer surface of the coronary stent. This proprietary technology is designed to significantly reduce the amount of polymer and drug to which the vessel is exposed, by eliminating the polymer and the drug on the inner surface of the stent, where endothelial cell growth is required for healing. Once the drug has been delivered, the biodegradable coating resorbs, leaving behind only the bare metal stent. This approach is intended to provide the same degree of restenosis reduction as a conventional drugeluting stent with faster and more complete vessel healing after stent implantation. We intend to apply this technology to our next generation platforms, which we believe will set a new standard for DES performance and be a key ingredient to continuing our worldwide DES leadership. WE ALREADY HAVE IT!!!!! Jim Tobin, Former CEO of Boston Scientific

8 Biosensors Drug-Eluting Stent Technology PLA carrier coating is co-released and degrades to CO2 + Water in ~ 6-9 months Higher drug carrying capacity of PLA polymer results in 1/2 to 1/3 the amount of carrier polymer used vs. durable coatings When the drug is gone, the carrier coating also gone Principle: Return closer to long term experience/risk profile of BMS after PLA/drug coating is eluted Stent Strut Stent Strut Stent with biodegradable drug coating, abluminal only coating After release of biodegradable coating

9 PROPRIETARY BA9 DRUG A rapamycin derivative developed specifically for stent application by Biosensors Effective immunosuppressive and anti-proliferative properties Reduced systemic exposure and more localized drug effect due to highest lipophilic profile and abluminal coating LIPOPHILICITY COMPARISON Highest lipophilic and hydrophobic properties of commercially available limus drugs: Minimizes attraction to blood and maximizes tissue absorption Minimizing drug release into bloodstream +/- 2.8% (valid for all drugs tested) *Data on file

10 Biosensors Drug-Eluting Stent R&D Pipeline Current DES Platform BioMatrix Biolimus A9 PLA Polymer Stainless Steel Stent Next Gen DES Platform Flex LEADERS DES Biolimus A9 PLA Polymer Stainless Steel Stent New Design Long length stents Long-term DCS & DES Platforms BioFreedom Biolimus A9 No PLA polymer Surface treatments Thinner and more flexible stent platform Improved stent delivery system

11 BioFreedom Abluminal BA9-coated stent Special surface holds drug in abluminal surface structures Potential advantages: Avoid long term late adverse effects that might be attributable to the polymer Improved surface integrity since there is no polymer to be sheared or pealed away from the stent struts Improved/faster healing without polymer Ultimately demonstrate reduced need of dual anti-platelet therapy

12 LEADERS All-Comers Trial Lancet 2008;327 (Sept 1)

13 LEADERS: Clinical outcomes at 9 months LEADERS is the first head-to-head randomized study between the two drug-eluting stent systems (DES) in a real world, all comers population using clinical results as its primary endpoint. Clinical outcome Cardiac death, MI, or clinically indicated TVR Biolimus-eluting stent, n=857 (%) Sirolimus-eluting stent, n=850 (%) Odds ratio (95% CI) ( ) Death ( ) Cardiac death ( ) MI ( ) Clinically indicated TVR ( ) Any TVR ( ) Source: Michael O Riordan, LEADERS: Solid nine-month data on biolimus-eluting stent with biodegradable polymer,

14 LEADERS Results at 24 Months % BES SES 1-year HR 0.88 [0.66 to 1.17] p = 0.37* 12.1% -12% 10.7% Δ 1.4% 2-year HR 0.84 [0.65 to 1.08] p = 0.18* 15.4% 13.0% -16% Δ 2.4% MACE = Cardiac Death, MI, or Clinically-Indicated TVR *P values for superiority 4 Klauss V., TCT Months

15 LEADERS: Summary clinical data at 24 months BioMatrix performance continues to improve vs. Cypher Potentially superior performance in higher risk patients LST is very few specific cases SVG patients Potentially strong data regarding DAPT potential long-term cost savings for patients Source: Michael O Riordan, LEADERS: Solid 24 data on biolimus-eluting stent with biodegradable polymer,

16 BioFreedom FIM Clinical Study Objectives Determine that polymer-free drug-coated stent is as safe as the current generation DES products Obtain enough data to design long-term study and product development program to position BioFreedom as the next generation of therapy the drugcoated stent with minimal DAPT therapy First cohort 75 patients 4 month follow up 25 standard dose BA9 patients 25 low dose BA9 patients 25 Taxus Liberte patients Second cohort 105 patients 12 month follow up DAPT therapy recommended for 6 months

17 BioFreedom Clinical Results Summary Equivalent safety and efficacy to Taxus with first 75 patient group Significant reduction in late loss at 4 months compared to Taxus IVUS results confirmed the angiographic findings No stent thrombosis in any of the patients in the study through 4 months We await the results for the 2 nd Cohort to confirm that these encouraging results are sustained over one year

18 Goal of 10% Market Share OUS for DES Products BioMatrix approved in most major geographies OUS Recently approved in Korea; French approval anticipated before 31 March 2010 China approval in process Currently operating at 5% to 7% share in countries where BioMatrix is approved Market share exceeds of 20% in some geographies Relationships established with key opinion leaders through clinical efforts LEADERS BioFreedom BEACON Trials Next generation DES product

19 Europe and SE Asia Presence Western Europe 15 Direct Sales staff UK,France,CH,Sweden 6 Biosensors Distributor Managers 17 Distributors with 95 staff. APAC 12 Direct Sales People HK,Taiwan,Singapore,Indonesia,Malaysia 10 Biosensors Sales team 11 Distributors with 65 staff.

20 ROW Infrastructure Russia/CIS/EEU 2 Biosensors Sales 14 Distributors with 62 staff. Japan 23 Biosensors Sales / customer service team 1 Distributor with 50 staff. Canada 1 Biosensors Sales person 1 Distributors with 8 staff. LAM 3 Biosensors Sales team 9 Distributors with 65 staff. Middle East/Africa 4 Biosensors Sales team 12 Distributors with 53 staff. India/Pakistan/BD 10 Biosensors Staff 3 Distributors with 70 staff. 20

21 Record Product Revenues US$ MM $30.0 $25.0 $20.0 $15.0 $10.0 $5.0 $- FY09 Q1 FY09 Q2 FY09 Q3 FY09 Q4 FY10 Q1 FY10 Q2 DES IVP CCP

22 Drug-Eluting Stent Sales Growth US$MM $12.5 $10.0 $7.5 $5.0 $7.2m $8.2m $11.1m $10.7m $11.5m $12.8m $2.5 $- FY09 Q1 FY09 Q2 FY09 Q3 FY09 Q4 FY10 Q1 FY10 Q2

23 Measuring Change through Results * Operating losses and cash flows adjusted for exchange gains or losses, Terumo US$40.0 million payment in Q1 FY 09

24 Key markets in Asia Pacific (ex Japan) Global Drug-Eluting Stent Market Key markets and projected % contribution in APAC (ex Japan)

25 China 50% Ownership of JWMS JWMS founded 2003 Biosensors acquired 50% interest in JWMS in September 2007 (Shandong Weigao owns the other 50%) 246 Employees manufacturing and operations; 60 sales representatives Single product Excel DES Clinical study (CREATE) over 2,000 patients largest ever China-based DES clinical trial JWMS is one of the top three DES companies in China

26 JWMS Update Weigao and Biosensors continue as JV partners Biosensors and Weigao each consolidate 50% of JWMS profits Biosensors continues to sell catheters to JWMS for Excel DES Biosensors working actively to obtain regulatory approval for BioMatrix in China Future relationship has many possibilities Distribution OEM Manufacturing Joint Clinical Trials Dividends

27 JWMS Summary Financial Data JWMS Quarterly Revenues JWMS Annual Revenues $20.0 $50.0 $47.1 $15.0 $10.0 $10.7 $9.8 $12.2 $9.5 $11.1 $14.4 $16.0 $15.9 $40.0 $30.0 $23.3 $35.4 $31.9 $5.0 $20.0 $- Q3 08 Q4 08 Q1 09 Q2 09 Q3 09 Q4 09 Q1 10 Q2 10 $10.0 $- FY 2007 FY 2008 FY H FY 2010 JWMS Quarterly Net Profits JWMS Annual Net Profits $9.0 $7.9 $20.0 $17.3 $17.9 $6.0 $3.0 $4.2 $4.2 $3.9 $3.0 $4.6 $6.4 $6.3 $15.0 $10.0 $5.0 $9.5 $15.0 $- $- Q3 08Q4 08Q1 09Q2 09Q3 09Q4 09Q1 10Q1 10 FY 2007 FY 2008 FY H FY 2010

28 Terumo Licensing Relationship DES technology license all elements; Nobori DES received CE mark approval in January 2009 Territories outside USA and Japan non-exclusive license expires in 2013 Substantially all of the Company s current license revenues are derived from non-exclusive Terumo license Japan- exclusive license expires 5 years from date of market launch Japan market US$600 million, largest single country outside USA Terumo license revenues after Japan approval will greatly enhance profitability

29 Biosensors Key Assets and Value Components Leading DES technology position in Europe, Asia and Latin America markets - goal of 10% share in 3 years 50% ownership position in one of the leading DES companies in China is a very undervalued asset License arrangement with largest medical device manufacturer in Japan for Japan and worldwide markets (excluding USA) Biosensors owns all of its DES technology

30 Next for Biosensors FYE 31 March 2011 plans and guidance Capitalize on China business opportunity Continued cost structure modification R&D pipeline and clinical data progress Terumo approval in Japan Additional strategic relationships to accelerate growth opportunity