Forward Looking Statements
Certain statements herein include forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. 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.
Overview of Biosensors
• Founded in 1990 – Public since 2005 (Singapore exchange b20.si)
• Interventional cardiology and critical care product lines – interventionalcardiology represents primary business
• Global presence - USA, Switzerland, The Netherlands, China, India,Indonesia, Japan and Singapore
• Significant restructuring over the past 15 months
Newport Beach, USA
Tokyo, Japan
Weihai, China
SwitzerlandThe Netherlands
India
Singapore
Transforming Biosensors’ Technology into Shareholder Value
Restructure Operations
Focused DES R&D Pipeline
10% OUS DES Market
Share
Strengthen Asia
Position
Strong Clinical
Data
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
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 drug-eluting 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
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 drug-eluting 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
WE ALREADY HAVE IT!!!!!
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
StentStrut
StentStrut
Stent with biodegradable drug coating, abluminal
only coating
After release ofbiodegradable coating
+/- 2.8% (valid for all drugs tested)
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 dueto 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
*Data on file
Biosensors Drug-Eluting Stent R&D Pipeline
Current DES PlatformBioMatrix
• Biolimus A9
• PLA Polymer
• Stainless Steel Stent
Next Gen DES Platform
Flex
Long-term DCS & DES PlatformsBioFreedom
• LEADERS DES
• Biolimus A9
• PLA Polymer
• Stainless Steel Stent –New Design
• Long length stents
• Biolimus A9
• No PLA polymer
• Surface treatments
• Thinner and more flexible stent platform
• Improved stent delivery system
• 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
BioFreedom™ Abluminal BA9-coated stent
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 outcomeBiolimus-eluting stent,
n=857 (%)Sirolimus-eluting stent,
n=850 (%)Odds ratio (95%
CI)
Cardiac death, MI, or clinically
indicated TVR9.2 10.5 0.88 (0.64 - 1.19)
Death 2.6 2.8 0.91 (0.51 - 1.62)
Cardiac death 1.6 2.5 0.66 (0.34 - 1.30)
MI 5.7 4.6 1.25 (0.82 - 1.92)
Clinically indicated TVR
4.4 5.5 0.79 (0.52 - 1.22)
Any TVR 5.7 7.3 0.77 (0.53 - 1.13)
Source: Michael O’Riordan, LEADERS: Solid nine-month data on biolimus-eluting stent with biodegradable polymer, http://www.theheart.org/article/899961.do
LEADERS Results at 24 Months
MACE = Cardiac Death, MI, or Clinically-Indicated TVR*P values for superiority4 Klauss V., TCT 2009
%
Months
13.0%
15.4%
2-year HR0.84 [0.65 to 1.08]
p = 0.18*
Δ 2.4%12.1%
10.7%
1-year HR0.88 [0.66 to 1.17]
p = 0.37*
Δ 1.4%
0
5
10
15
20
03 6 9 12 15 18 21 24
BES
SES
-12%
-16%
LEADERS: Summary clinical data at 24 months
Source: Michael O’Riordan, LEADERS: Solid 24 data on biolimus-eluting stent with biodegradable polymer, http://www.theheart.org/article/899961.do
• 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
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 “drug-coated 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
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 2nd Cohort to confirm that these encouraging results are sustained over one year
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
Europe and SE Asia Presence
APAC12 Direct Sales People
HK,Taiwan,Singapore,Indonesia,Malaysia 10 Biosensors Sales team
11 Distributors with 65 staff.
Western Europe15 Direct Sales staff – UK,France,CH,Sweden
6 Biosensors Distributor Managers17 Distributors with 95 staff.
ROW Infrastructure
20
LAM3 Biosensors Sales team
9 Distributors with 65 staff.
Canada1 Biosensors Sales person1 Distributors with 8 staff.
Middle East/Africa4 Biosensors Sales team12 Distributors with 53
staff.
Japan23 Biosensors Sales /
customer service team1 Distributor with 50 staff.
Russia/CIS/EEU2 Biosensors Sales
14 Distributors with 62 staff.
India/Pakistan/BD10 Biosensors Staff 3 Distributors with
70 staff.
Record Product Revenues
US$ MM
$-
$5.0
$10.0
$15.0
$20.0
$25.0
$30.0
FY09 Q1 FY09 Q2 FY09 Q3 FY09 Q4 FY10 Q1 FY10 Q2
DES IVP CCP
Drug-Eluting Stent Sales Growth
$-
$2.5
$5.0
$7.5
$10.0
$12.5
FY09 Q1 FY09 Q2 FY09 Q3 FY09 Q4 FY10 Q1 FY10 Q2
$7.2m $8.2m$11.1m $10.7m
$11.5m$12.8m
US$MM
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
Key markets in Asia Pacific (ex Japan)
Global Drug-Eluting Stent MarketKey markets and projected % contribution in
APAC (ex Japan)
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 - 186 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
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
JWMS – Summary Financial Data
$10.7 $9.8
$12.2
$9.5 $11.1
$14.4 $16.0 $15.9
$-
$5.0
$10.0
$15.0
$20.0
Q3 08
Q4 08
Q1 09
Q2 09
Q3 09
Q4 09
Q1 10
Q2 10
JWMS Quarterly Revenues
$4.2 $4.2 $3.9
$3.0
$4.6
$6.4 $6.3
$7.9
$-
$3.0
$6.0
$9.0
Q3 08Q4 08Q1 09Q2 09Q3 09Q4 09Q1 10Q1 10
JWMS Quarterly Net Profits
$23.3
$35.4
$47.1
$31.9
$-
$10.0
$20.0
$30.0
$40.0
$50.0
FY 2007 FY 2008 FY 2009 1H FY 2010
JWMS Annual Revenues
$9.5
$17.3 $17.9
$15.0
$-
$5.0
$10.0
$15.0
$20.0
FY 2007 FY 2008 FY 2009 1H FY 2010
JWMS Annual Net Profits
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
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