Filed by Boston Scientific Corporation
Pursuant to Rule 425 under the Securities Act of 1933
and deemed filed pursuant to Rule 14a-6
under the Securities Exchange Act of 1934
Subject Company: Guidant Corporation
Commission File No.: 333-131608
The following material relates to a presentation given by Boston Scientific at the Analyst Meeting at ACC and made available on Boston Scientific’s website.
Link to searchable text of slide shown above
Searchable text section of graphics shown above
[LOGO]
Safe Harbor:
Forward-Looking Statements
This presentation contains “forward-looking statements,” including, among other statements, statements regarding the proposed business combination between Boston Scientific Corporation and Guidant Corporation, and the anticipated consequences and benefits of such transaction. Statements made in the future tense, and words such as “anticipate”, “expect”, “project”, “believe”, “plan”, “estimate”, “intend”, “will”, “may” and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations, but are subject to certain risks and uncertainties, many of which are difficult to predict and are beyond the control of Boston Scientific or Guidant. Relevant risks and uncertainties include those referenced in Boston Scientific’s and Guidant’s filings with the Securities and Exchange Commission (“SEC”) (which can be obtained as described in “Additional Information” below), and include: general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. Risks and uncertainties relating to the proposed transaction include: required regulatory approvals will not be obtained in a timely manner, if at all; the proposed transaction will not be consummated; the anticipated benefits of the proposed transaction will not be realized; and the integration of Guidant’s operations with Boston Scientific will be materially delayed or will be more costly or difficult than expected. These risks and uncertainties could cause actual results to differ materially from those expressed in or implied by the forward-looking statements, and therefore should be carefully considered. Neither Boston Scientific nor Guidant assumes any obligation to update any forward-looking statements as a result of new information or future events or developments.
Safe Harbor: Additional Information
Boston Scientific and Guidant have filed a definitive prospectus/joint proxy statement with the SEC in connection with the proposed transaction. The material contained herein is not a substitute for the definitive prospectus/joint proxy statement or any other documents that Boston Scientific and Guidant have filed or will file with the SEC. Investors and security holders are urged to read the definitive prospectus/joint proxy statement and any other relevant documents filed or to be filed by Boston Scientific or Guidant, because they contain or will contain important information about the proposed transaction. The definitive prospectus/joint proxy statement is, and other documents filed or to be filed by Boston Scientific and Guidant with the SEC are or will be, available free of charge at the SEC’s website (www.sec.gov) or from Boston Scientific by directing a request to Boston Scientific Corporation, One Boston Scientific Place, Natick, Massachusetts 01760-1537, Attention: Milan Kofol, Investor Relations, or from Guidant by directing a request to Guidant Corporation, 111 Monument Circle, 29th Floor, Indianapolis, Indiana 46204, Attention: Investor Relations.
Boston Scientific, Guidant and their respective directors, executive officers and other employees may be deemed to be participants in the solicitation of proxies from the security holders of Boston Scientific or Guidant in connection with the proposed transaction. Information about Boston Scientific’s directors and executive officers is available in Boston Scientific’s Annual Report on Form 10-K for the year ended December 31, 2005, and information about Guidant’s directors and executive officers is available in Guidant’s Annual Report on Form 10-K for the year ended December 31, 2005. Additional information about the interests of potential participants is included in the definitive prospectus/joint proxy statement referred to above.
Agenda
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Introduction |
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Larry Best, Executive Vice President and Chief Financial Officer |
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Business Update |
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Paul LaViolette, Chief Operating Officer |
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TAXUS Clinical Program Update |
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Joerg Koglin, M.D., Senior Medical Director, Vice President, Cardiovascular Clinical Sciences |
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Cardiovascular Business Update |
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Paul LaViolette, Chief Operating Officer |
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Q&A |
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All |
[LOGO]
Key Take-Aways
• DES Global Leadership (x-Japan) strengthening
• U.S. TAXUS® share stable at 54%
• Q4 TAXUS® Liberté™ Launch
• Int’l TAXUS share stable > 50%
• TAXUS® Liberté™ Launch Expansion
• Endeavor™ / Cypher® share exchange
• Compelling pipeline, progressing steadily
• Apex, Barracuda, Petal
• Xience* program upside
• TAXUS Clinical Program repeatedly demonstrates safety & efficacy in more complex patients and lesions
• TAXUS V-ISR
*Subject to closing of Guidant transaction
Key Take-Aways
• Warning Letter remediation making measured progress with new systems
• Guidant on track
• VI Divestiture and close
• Week of April 3rd
• Diversification and Growth
• Cardiovascular / Full BSC continues strong performance
Corporate Warning Letter
Internal Progress Underway
Quality System Components
• Management Responsibility
• Product Surveillance/MDR Reporting
• Field Action Decision Making
• CAPA
• Leading BSC change that will be
• Company- wide
• Cross-functional
• Rapid
• Comprehensive
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Corrective Action |
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Global
Quality |
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Compliance
Excellence through |
Warning Letter Response Status
• Filed response with FDA 3/3
• Currently under review
• Face to Face meetings being scheduled
• Monthly updates to be provided to FDA
• On-going execution of remediation
• Measured progress
• Expansion of new systems
• Global Complaint System
• Global CAPA System
Boston Scientific Analyst Meeting
Clinical Research Update
[LOGO]
Joerg Koglin, MD
Senior Medical Director, Vice President Medical Sciences
[LOGO]
The DES Clinical Trial Landscape in Perspective
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1 Year |
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2 Years |
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3 Years |
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[LOGO] |
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n=4487 |
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n=1204 |
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n=987 |
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[LOGO] |
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n=3792 |
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n=902 |
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n=683 |
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[LOGO] |
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n=1027 |
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n=100 |
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[LOGO] |
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n=694 |
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[LOGO] |
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n=40 |
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[LOGO] |
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n=28 |
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Atlanta, March 13, 2006 |
ACC Clinical Research Update |
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12
SYNTAX: Expanding into 3-Vessel and Left Main
[LOGO]
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All patients with Left main and/or 3-Vessel Disease |
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Minimal In- or Exclusion Criteria |
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Local Heartteam (Interventional Cardiologist & Cardiothoracic Surgeon) |
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eligible for both |
eligible for only one |
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Randomized Trial |
Nested Registries |
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CABG |
TAXUS |
CABG |
TAXUS |
14
SYNTAX on Track to Address
Remaining Needs
Indication Expansion to
3-Vessel Disease & LM
[LOGO]
Enrollment status
[CHART]
15
SYNTAX – Expanding Procedural Complexity
[LOGO]
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# Lesions per patient |
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4.11±1.74 |
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(1,12) |
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# of stents per patients |
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4.58±2.19 |
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(1,13) |
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Patients with total stent length >100 mm |
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34.3% |
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Site reported as of March 10, 2006
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SYNTAX – in perspective
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[LOGO] |
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[LOGO] |
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FREEDOM |
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SYNTAX |
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2- and 3-vessel disease in diabetics |
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3-vessel disease and/or left main |
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Superiority trial |
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Equivalence trial |
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2300 patients planned |
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1800 patients planned |
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5 year MACCE |
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1 year MACCE |
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Study start April 2005 |
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Study start March 2005 |
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100
patients |
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1101
patients |
18
TAXUS Changing the Way Patients Are Treated
[GRAPHIC]
simultaneous publication in JAMA available online since Mar 12, 2006 available in print on Mar 15 2006
20
Why In-Stent Restenosis ?
• an unsolved clinical problem
• 12% of the US market is still BMS (150,000 stents in 2005)
• 50% of the OUS market is still BMS (1,000,000 stents in 2005)
• an excellent surrogate for lesion complexity
“if it works well in ISR, it will work well in all lesions”
• a well defined restenotic challenge model allowing technology comparisons
• Brachytherapy versus DES
• DES versus DES
21
In-stent Restenosis - an Unsolved Clinical Problem
[GRAPHIC]
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TLR |
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TLR |
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Focal |
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19 |
% |
17 |
% |
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Diffuse |
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35 |
% |
25 |
% |
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Proliferative |
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50 |
% |
30 |
% |
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Total Occlusion |
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83 |
% |
? |
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Mehran et al.; Circulation 1999; 100: 1872-1878
Costantino et al.; Am J Cardiol 2001; 92: 1214-1217
22
In-Stent Restenosis in TAXUS V ISR
before procedure
[GRAPHIC]
lesion length 39 mm
vessel diameter 2.5 mm
diameter stenosis 77%
after procedure
[GRAPHIC]
2 TAXUS Express stents
3.0x24mm and 3.0x32 mm
9 months after
[GRAPHIC]
23
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Study Design |
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[LOGO] |
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Patients with in-stent restenosis of a previously implanted bare metal stents in a native coronary artery lesions |
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£ 46mm in length and ³ 2.5mm to £ 3.75mm in diameter |
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(n=396) |
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Randomize 1:1 |
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Brachytherapy |
TAXUS |
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Primary endpoint – 9-month
Target Vessel Revascularization (TVR) |
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24
TAXUS Approach
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PTCA catheter |
Old stent |
New stent |
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[GRAPHIC] |
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5mm |
In-Stent |
5mm |
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Proximal |
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Distal |
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Injury Segment |
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Area in which balloon was inflated against the wall |
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Analysis Segment |
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Stented segment plus 5 mm on each edge |
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25
Vascular Brachytherapy Approach
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PTCA catheter |
Old stent |
b radiation source |
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[GRAPHIC] |
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Injury Segment |
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Area in which balloon was inflated against the wall |
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5mm |
Radiation Segment |
5mm |
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Proximal |
Area exposed to brachytherapy |
Distal |
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Analysis Segment |
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Radiation segment plus 5 mm on each edge |
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26
Patient Enrollment and Follow-up [LOGO]
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Randomized |
TAXUS Registry |
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(n=396) |
(n=25) |
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Brachytherapy |
TAXUS |
TAXUS Registry |
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9m Follow-Up |
9m Follow-Up |
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Brachytherapy |
TAXUS |
TAXUS Registry |
27
Evolving Statistical Standards
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Mean |
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Median |
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Normal distribution |
statistical discussion as
part |
Non-Normal distribution |
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Reported as |
Reported as |
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‘mean ± standard deviation’ |
‘median (interquartile range)’ |
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Parametric comparison taking |
Non-parametric comparison ranking |
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advantage of distribution type |
each observation |
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Two-Sample t-test |
Wilcoxon Rank Sum test |
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reported for cross-reference |
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used for analysis of continuous |
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across trials |
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angiographic variables |
32
No Differences in Aneurysms
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Brachytherapy |
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TAXUS |
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p |
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Post-Procedure |
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6 (3.0 |
%) |
3 (1.6 |
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0.50 |
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9-Month Follow-up |
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8 (4.7 |
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2 (1.2 |
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0.06 |
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Paired Analysis |
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Resolved |
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0 |
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1 (0.6 |
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1.00 |
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Persistent |
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5 (2.9 |
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1 (0.6 |
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0.12 |
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Late Acquired |
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3 (1.8 |
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1 (0.6 |
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0.37 |
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Aneurysms defined as >20% increase in diameter compared to reference vessel
36
Conclusions – Superiority in a Non-Inferiority Trial
The use of TAXUS Express for treatment of in-stent restenosis has been shown to be
• safe – with low rates for target vessel thrombosis, myocardial infarction, late acquired aneurysms
• effective – with TLR rate of 6.3% and an angiographic restenosis rate of 7.0%
when compared to vascular brachytherapy as the preexisting gold standard .
37
TAXUS V ISR – In Perspective
Study Design
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[LOGO] |
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[LOGO] |
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SISR |
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TAXUS V ISR |
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CYPHER vs VBT |
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TAXUS vs VBT |
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384 patients 2:1 |
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396 patients 1:1 |
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6 months angio f/u |
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9 month angio f/u |
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RVD >2.5 and
<3.5mm |
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RVD >2.5 and
<3.75mm |
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no additional PCI |
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additional PCI allowed in non target vessel |
38
TAXUS V ISR – In Perspective
Baseline characteristics
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[LOGO] |
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[LOGO] |
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SISR |
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TAXUS V ISR |
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9.3% insulin-treated |
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19.5% insulin treated |
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17.2 mm lesion length |
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18.5 mm mean lesion length |
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not reported |
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2.68 mm mean RVD |
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not reported |
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81.9% B2/C lesions |
39
TAXUS V ISR – In Perspective
Clinical 9-Month Outcomes
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[LOGO] |
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[LOGO] |
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SISR |
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TAXUS V ISR |
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8.5% |
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TLR |
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6.3% |
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10.8% |
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TVR |
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10.5% |
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12.4% |
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TVF |
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11.5% |
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0.4% |
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Q-wave MI |
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0.5% |
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2.3% |
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Non-Q-wave MI |
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3.1% |
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2 pts (0.8%) |
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Stent thrombosis |
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3 pts (1.6%) |
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one patient
would not be included |
40
TAXUS V ISR – In Perspective
Angiographic Outcomes
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[LOGO] |
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[LOGO] |
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SISR |
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TAXUS V ISR |
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0.27±0.65 mm |
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Late Loss |
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0.29±0.54 mm |
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at 6-Month |
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analysis segment |
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at 9-Month |
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not reported |
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Late Loss |
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0.38±0.49 mm |
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in-stent |
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at 9-Month |
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19.8% |
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Binary restenosis |
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14.5% |
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at 6-Month |
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analysis segment |
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at 9-Month |
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not reported |
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Binary restenosis |
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7.0% |
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in-stent |
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at 9-Month |
41
[LOGO]
TAXUS® Liberté™ Stent System
International Market Performance
The good news:
• Impacting international markets
• Increasing revenue by approximately 16%
• Converting accounts previously unable to convert
The better news
• Not fully launched in largest international markets
• Maintaining share and ASP in crowded market
International DES Space is Crowding
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[LOGO] |
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[LOGO] |
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[LOGO] |
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• Driver |
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• Doubt |
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[LOGO] |
[LOGO] |
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• Share |
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• Pipeline |
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• Simplicity |
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[LOGO] |
[LOGO] |
[LOGO] |
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• Early |
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• Expectations |
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International
TAXUS® Liberté™ Stent Sales Increasing
[CHART]
• Launched in all EU countries & 14 Operations in IC
• >65% Conversion; Target >70% at end of Q1’06
• ASP: Avg. 5% price premium over TAXUS Express
BSC Internal Estimates
TAXUS® Market Share remains stable…
Cypher® share declining
[CHART]
• TAXUS steady
• Cypher® down significantly
• Endeavor™ hitting plateau
• Endeavor™ share coming from Cypher®
TAXUS® Liberté™ Launched in 65% of Int’l Market, 35% Additional Opportunity
[GRAPHIC]
TAXUS Liberté launched in all EU. In 4 months later, GDR, ESP, ITA, & UK gained 16% revenue
[GRAPHIC]
TAXUS Liberté has launched in 14/ 21 IC markets; largest yet to come (Brazil, Australia, Canada)
If France follows trend, potential 10% market share increase
• France/Belgium received reimbursement and launched in late February 2006
• 10% Share Gain Possible
[GRAPHIC]
[CHART]
65% of International is now converted from TAXUS Express to TAXUS Liberté
TAXUS® Liberté™ Stent Design
Achieving
the Optimal Balance
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[GRAPHIC] |
[GRAPHIC] |
[GRAPHIC] |
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Conformability |
Deliverability |
Side Branch Access |
This product is not yet approved for sale in the United States.
Balloon Withdrawal Reduced
Significant improvement in bench testing under identical conditions
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[CHART] |
[CHART] |
85% of evaluators rated TAXUS Liberté Well or Very Well in “withdrawal of stent delivery system”
Bench testing performed internally by Boston Scientific. Data on file.
Advanced Deliverability of Liberté™ Stent Driving Up BMS Share in U.S.
[CHART]
BSC Internal Estimates
U.S. TAXUS® Express2 TM
Market Share Stable
[CHART]
Sequential Sales
Competitor supply, publications and campaign
BSC Internal Estimates
Major DES Activities in ‘06
Q1
• TAXUS® Assurance
• ACC:
• STENT registry
• TAXUS V ISR
• ARRIVE II
• REWARDS Registry
Q2
• ATLAS 9 mo
• TAXUS VI
• TINY Trial Enrollment
Q3
• Xience* launch OUS
• TAXUS® Express2™
Expanded Matrix
• 2.25/4.0 mm
• TAXUS® Liberté™
• Launch Prep
Q4
• TAXUS® Liberté™ Launch
• TCT:
• TAXUS IV 4yr
• TAXUS V 2yr
• Arrive II 1yr
• Olympia
*Subject to closing of Guidant transaction
DES Regulatory Update
• TAXUS® Liberté™ U.S.
• final PMA module submitted
• Launch expected Q4 ’06
• Xience* CE Mark Q1 ’06
• Launch expected Q3 ’06
• TAXUS® ExpressTM Japan
• approval expected Q1 ’07
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*Subject to closing of Guidant transaction |
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BSC Internal Estimates |
Apex™ Design
Radical
Advances
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TruFeelTM |
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[GRAPHIC] |
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Hypotube |
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[GRAPHIC]
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Nano-Composite |
[GRAPHIC] |
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Outer Shaft |
TAXUS® Apex™ Stent System
Commercialization
Milestones
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Design Freeze |
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Complete |
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CE Submission |
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2H 2006 |
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PMA Submission |
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2H 2007 |
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Japan Submission |
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2H 2007 |
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EU/IC Launch |
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1H 2007 |
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U.S. Launch |
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1H 2008 |
BSC Internal Estimates
TAXUS® Barracuda Stent System
Technology
Driving DES Performance
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Paclitaxel/ Translute™ drug delivery |
[GRAPHIC] |
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Geometry designed for drug delivery |
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PERSS: New stent material- thin struts without compromise |
[GRAPHIC] |
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Increased flexibility & Conformability |
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Optimal radiopacity |
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High radial strength |
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Apex™-based delivery system |
[GRAPHIC] |
TAXUS® Barracuda Stent System
Commercialization
Milestones
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Design Freeze |
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1Q 2006 |
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IDE Submission |
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2H 2006 |
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CE Submission |
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2H 2007 |
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PMA Submission |
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1H 2008 |
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Japan Submission |
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2H 2008 |
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EU/IC Launch |
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1H 2008 |
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U.S. Launch |
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1H 2009 |
BSC Internal Estimates
TAXUS® PetalTM Bifurcation
Carina Coverage, Aligning Architecture
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[GRAPHIC] |
[GRAPHIC] |
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[GRAPHIC] |
[GRAPHIC] |
Rapid Integration of Acquired Bifurcation Stent and BSC Drug-Elution Technology |
Bifurcations are involved in 25-30% of all interventions
TAXUS® PetalTM Bifurcation Status
[GRAPHIC]
• World-Class Technology
• New stent design and material
• Apex’ based delivery system
• Chronic drug-coated pre-clinical studies underway
• Promising acute performance
• Targeting end of 2006 to begin first human clinicals
BSC Internal Estimates
DES Pipeline: Sustainable Advantage
Only TAXUS provides incremental improvements year after year
[GRAPHIC]
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*Subject to closing of Guidant transaction |
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BSC Internal Estimates |
Interventional Cardiology Pipeline
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2005 |
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2006 |
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2007 |
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2008 |
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Q1 |
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Q2 |
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Q3 |
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Q4 |
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Q1 |
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Q2 |
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Q3 |
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Q4 |
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Q1 |
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Q2 |
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Q3 |
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Q4 |
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Q1 |
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Q2 |
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[GRAPHIC] |
[GRAPHIC] |
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IQ Guidewires |
Delta Guidewire |
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[GRAPHIC] |
[GRAPHIC] |
[GRAPHIC] |
[GRAPHIC] |
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FW EZ/EZ Vascular Protection |
FW EZ CAS Indication & FW EZ Small (2.25-3.5mm) |
FW EZ Large (7.0mm) |
Rubicon NG Device 2.3F/Sheathless |
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[GRAPHIC] |
[GRAPHIC] |
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Maverick PTCA Balloons |
NG PTCA Balloon (Apex) |
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[GRAPHIC] |
[GRAPHIC] |
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Plainview IVUS System |
IVUS NG Platform (iLab & iSight) |
BSC Internal Estimates
Peripheral & Vascular Surgery Pipeline
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2005 |
|
2006 |
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2007 |
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2008 |
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Q1 |
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Q2 |
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Q3 |
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Q4 |
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Q1 |
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Q2 |
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Q3 |
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Q4 |
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Q1 |
|
Q2 |
|
Q3 |
|
Q4 |
|
Q1 |
|
Q2 |
|
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[GRAPHIC] |
[GRAPHIC] |
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Polarcath |
Sterling .018/.014 Balloon |
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[GRAPHIC] |
[GRAPHIC] |
[GRAPHIC] |
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Sentinol SE Stent |
EPIC SE Stent |
New Delivery System |
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[GRAPHIC] |
[GRAPHIC] |
[GRAPHIC] |
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PV Ultra 2 Cutting Balloon |
ZipWire Hydrophilic GW |
New Fusion Graft |
BSC Internal Estimates
CV Core Business Summary
Q1 ’06, US MS Rankings
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Rank |
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BSC |
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Cordis |
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GDT |
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MDT |
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INTERVENTIONAL CARDIOLOGY |
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|
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|
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Bare Metal Stents |
|
2 |
|
4 |
|
1 |
|
3 |
|
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Balloon Catheters |
|
1 |
|
4 |
|
2 |
|
3 |
|
|
Guide Wires |
|
2 |
|
3 |
|
1 |
|
4 |
|
|
Guide Catheters |
|
2 |
|
1 |
|
4 |
|
3 |
|
|
Diagnostic Catheters |
|
2 |
|
1 |
|
N/A |
|
3 |
|
|
Atherectomy |
|
1 |
|
N/A |
|
N/A |
|
N/A |
|
|
IVUS |
|
1 |
|
N/A |
|
N/A |
|
N/A |
|
|
Embolic Protection |
|
1 |
|
4 |
|
3 |
|
2 |
|
|
Fluid Management |
|
1 |
|
3 |
|
N/A |
|
N/A |
|
|
Vascular Sealing |
|
N/A |
|
N/A |
|
N/A |
|
N/A |
|
|
|
|
|
|
|
|
|
|
|
|
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PERIPHERAL / VASCULAR SURGERY |
|
|
|
|
|
|
|
|
|
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Peripheral Stents |
|
2 |
|
1 |
|
3 |
|
5 |
|
|
Balloon Catheters |
|
1 |
|
2 |
|
4 |
|
N/A |
|
|
Guide Wires |
|
1 |
|
4 |
|
5 |
|
N/A |
|
|
EVAR |
|
N/A |
|
N/A |
|
N/A |
|
1 |
|
BSC Internal Estimates
Key Take-Aways
• DES Global Leadership (x-Japan) strengthening
• U.S. TAXUS® share stable at 54%
• Q4 TAXUS® Liberté™ Launch
• Int’l TAXUS share stable > 50%
• TAXUS® Liberté™ Launch Expansion
• Endeavor™ / Cypher® share exchange
• Compelling pipeline, progressing steadily
• Apex, Barracuda, Petal
• Xience* program upside
• TAXUS Clinical Program repeatedly demonstrates safety & efficacy in more complex patients and lesions
• TAXUS V-ISR
*Subject to closing of Guidant transaction
Key Take-Aways
• Warning Letter remediation making measured progress with new systems
• Guidant on track
• VI Divestiture and close
• Week of April 3rd
• Diversification and Growth
• Cardiovascular / Full BSC continues strong performance