watchman left atrial appendage closure device investor...
TRANSCRIPT
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WATCHMAN™
Left Atrial Appendage Closure Device
Investor Update
March 15, 2015
2 Boston Scientific Confidential – WATCHMAN™ Left Atrial Appendage Closure Device Investor Update – March 15, 2015
Safe Harbor for Forward-Looking Statements
This presentation contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of
1934. Forward-looking statements may be identified by words like “anticipate,”
“expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These
forward-looking statements are based on our beliefs, assumptions and estimates using
information available to us at the time and are not intended to be guarantees of future
events or performance. If our underlying assumptions turn out to be incorrect, or if
certain risks or uncertainties materialize, actual results could differ materially from the
expectations and projections expressed or implied by our forward-looking statements.
Factors that may cause such differences can be found in our most recent Form 10-K
and Forms 10-Q filed or to be filed with the Securities and Exchange Commission
under the headings “Risk Factors” and “Safe Harbor for Forward-Looking Statements.”
Accordingly, you are cautioned not to place undue reliance on any of our forward-
looking statements. We disclaim any intention or obligation to publicly update or revise
any forward-looking statements to reflect any change in our expectations or in events,
conditions, or circumstances on which they may be based, or that may affect the
likelihood that actual results will differ from those contained in the forward-looking
statements.
3
Joe Fitzgerald Executive Vice President and President,
Rhythm Management
Kenneth Stein, M.D. Chief Medical Officer,
Rhythm Management
4 Boston Scientific Confidential – WATCHMAN™ Left Atrial Appendage Closure Device Investor Update – March 15, 2015
WATCHMAN™ Left Atrial Appendage Closure Device
FDA Approved!
• First-of-its-kind device
• New option for U.S. patients
• Extensively studied:
• over 2,400 patients
• ~6,000 patient years of follow-up
• Registered in 75 countries
• Over 10,000 implants worldwide
5 Boston Scientific Confidential – WATCHMAN™ Left Atrial Appendage Closure Device Investor Update – March 15, 2015
WATCHMAN™ Device Global Market Opportunity
~15 million patients with atrial fibrillation
~7.5 million with CHADS2 ≥ 2
~2.5 million target patients
~50,000 procedures /
year
~50% with CHADS2 score ≥ 2
~2-4% annual prevalence
penetration
~$500M Source: BSC Estimates
~30-40% have reasons to seek alternative
global market opportunity by 2019
6 Boston Scientific Confidential – WATCHMAN™ Left Atrial Appendage Closure Device Investor Update – March 15, 2015
*OAT = Oral Anticoagulant Therapy; **NOAC = Novel Oral Anti-Coagulant
1 Go AS. et al, Heart Disease and Stroke Statistics—2013 Update: A Report From the American Heart Association. Circulation. 2013; 127: e6-e245
2 Jani, et al. Uptake of Novel Oral Anticoagulants in Patients with Non-Valvular and Valvular Atrial Fibrillation: Results from the NCDR-Pinnacle Registry. ACC 2014
3 Connolly, S. NEJM 2009; 361:1139-1151 – 2 years f-up (Corrected)
4 Patel, M. NEJM 2011; 365:883-891 – 1.9 years f-up, ITT
5 Granger, C NEJM 2011; 365:981-992 – 1.8 years f-u
6 BSC Estimates
WATCHMAN™ Device U.S. Market Opportunity
• 5 million Americans with atrial fibrillation, 50% with CHADS2 ≥ 21
• ~40% of patients indicated for OAT* do not take an OAT of any kind2
• >20% of patients in NOAC** trials discontinued drug within 2 years3,4,5
• Competitive device with stroke indication unlikely for at least 4 years
7 Boston Scientific Confidential – WATCHMAN™ Left Atrial Appendage Closure Device Investor Update – March 15, 2015
WATCHMAN™ Device Indications for Use
The WATCHMAN Device is indicated to reduce the risk of
thromboembolism from the left atrial appendage in patients with non-
valvular atrial fibrillation who:
– Are at increased risk for stroke and systemic embolism based on
CHADS2 or CHA2DS2-VASc scores and are recommended for
anticoagulation therapy;
– Are deemed by their physicians to be suitable for warfarin; and
– Have an appropriate rationale to seek a non-pharmacologic
alternative to warfarin, taking into account the safety and effectiveness
of the device compared to warfarin
8 Boston Scientific Confidential – WATCHMAN Left Atrial Appendage Closure Device Investor Update – March 15, 2015
WATCHMAN™ Device Patient Selection Considerations
– a history of major bleeding while
taking therapeutic anticoagulation
therapy
– the patient’s prior experience with
oral anticoagulation (if
applicable),
– a medical condition, occupation,
or lifestyle placing the patient at
high risk of major bleeding
secondary to trauma.
– the presence of indication(s) for
long-term warfarin use, other
than non-valvular atrial fibrillation
– overall medical status
– suitability for percutaneous,
trans-septal procedures
– ability to comply with the
recommended post-WATCHMAN
Device implant pharmacologic
regimen
Rationale for seeking an
alternative to warfarin:
Factors to consider for
WATCHMAN implantation :
9 Boston Scientific Confidential – WATCHMAN™ Left Atrial Appendage Closure Device Investor Update – March 15, 2015
WATCHMAN™ Device U.S. Launch Plan
• Cadenced launch to ensure positive patient
outcomes
• Available to clinical study sites and additional,
specialized centers the first year post approval
• Speed of rollout limited by number of qualified
physician trainers and BSC clinical specialists
• Ample supply to meet rollout plan
10 Boston Scientific Confidential – WATCHMAN™ Left Atrial Appendage Closure Device Investor Update – March 15, 2015
WATCHMAN™ Device Physician Training Program
Online Training
Phase 1 Phase 2 Phase 3+
Live professional
training with
physician faculty
Cadence of cases
supported by
clinical specialists
and optional
proctoring
11 Boston Scientific Confidential – WATCHMAN™ Left Atrial Appendage Closure Device Investor Update – March 15, 2015
WATCHMAN™ Device Reimbursement
• Coding and Payment rates in place: DRG 250 and 251
• Proactively working with CMS and societies on coverage pathway
• Exploring both local and national coverage options
• Applied for New Technology Add-on Payment for 2015
REIMBURSEMENT = Coding + Coverage + Payment Rates
12 Boston Scientific Confidential – WATCHMAN™ Left Atrial Appendage Closure Device Investor Update – March 15, 2015
Next Generation Device: WATCHMAN FLX™
• Design enhancements:
• Closed distal end with fluoro marker
• Full recapture & redeployment
• Expanded LAA treatment range
• Conformable frame design
• Expect EU approval, market evaluation, & full launch by Q415
• United States clinical evaluation to start early 2016
Pending CE Mark, not available for sale in the European Economic Area
13 Boston Scientific Confidential – WATCHMAN™ Left Atrial Appendage Closure Device Investor Update – March 15, 2015
• FDA approval post market study
• Contra-indicated patients study
• WATCHMAN FLX™ clinical evaluation in the United States
WATCHMAN™ Device Future Studies
14
Vivek Reddy, M.D. Director of the Cardiac Arrhythmia Service
Mount Sinai Medical Center
15 Boston Scientific Confidential – WATCHMAN™ Left Atrial Appendage Closure Device Investor Update – March 15, 2015
WATCHMAN™ Device: Addresses Unmet Medical Need
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2011Q1
2011Q2
2011Q3
2011Q4
2012Q1
2012Q2
2012Q3
2012Q4
Total on Oral
Anticoagulation
Warfarin
NOACs
Anticoagulant Use in Patients with
NVAF and CHADS2 ≥ 2
n=25719 n=29194 n=31582 n=36490 n=67102 n=70667 n=70320 n=71396
Source: Jani, et al. Uptake of Novel Oral Anticoagulants in Patients with Non-Valvular and Valvular Atrial Fibrillation: Results from the NCDR-Pinnacle Registry. ACC 2014.
16 Boston Scientific Confidential – WATCHMAN™ Left Atrial Appendage Closure Device Investor Update – March 15, 2015
Less Anticoagulation Use in Higher Risk Patients
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1 2 3 4 5 6
CHADS2 Score
p < 0.001
(n=27,164)
AF
Pati
en
ts U
sin
g
An
tico
ag
ula
tio
n
Anticoagulation Use Declines with
Increased Stroke Risk1
1. Piccini, et al., Pharmacotherapy in Medicare beneficiaries with atrial fibrillation. Heart Rhythm. 2012; 9:1403-1408
17 Boston Scientific Confidential – WATCHMAN™ Left Atrial Appendage Closure Device Investor Update – March 15, 2015
OAT Discontinuation and Risk of Major Bleeds
1 Connolly, S. NEJM 2009; 361:1139-1151 – 2 years f-up (Corrected)
2 Patel, M. NEJM 2011; 365:883-891 – 1.9 years f-up, ITT
3 Granger, C NEJM 2011; 365:981-992 – 1.8 years f-u
4 Giugliano, R. NEJM 2013; 369(22): 2093-2104 – 2.8 years follow-up.
Treatment
Study Drug
Discontinuation Rate
Major Bleeding
(rate/year)
Rivaroxaban1 24% 3.6%
Apixaban2 25% 2.1%
Dabigatran3
(150 mg) 21% 3.3%
Edoxaban4
(60 mg / 30 mg) 33 % / 34% 2.8% / 1.6%
Warfarin1-4 17 – 28% 3.1 – 3.6%
18 Boston Scientific Confidential – WATCHMAN™ Left Atrial Appendage Closure Device Investor Update – March 15, 2015
• Higher bleeding risk / older patients
• Previous falls or fall risk
• Prior stroke / TIA while on warfarin
• Inability to adhere with pharmacologic therapy
• High risk of injury occupations / activities
WATCHMAN™ Device Patient Candidates
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Q&A