st. jude medical 2015 annual investor meeting presentation
TRANSCRIPT
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ST. JUDE MEDICAL 2015INVESTOR CONFERENCEFebruary 6, 2015
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WELCOME AND OPENING REMARKS
Dan Starks, Chairman, President and CEO
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This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 28, 2013 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2014. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
The Company will be using non-GAAP financial measures (e.g., constant currency sales growth, adjusted net earnings, etc.) in this presentation. Investors should consider non-GAAP measures in addition to, and not as a substitute for, financial performance measures prepared in accordance with GAAP. For a reconciliation of our non-GAAP financial measures to our GAAP results, please visit the investor relations portion of our website: investors.sjm.com.
FORWARD-LOOKING STATEMENTS
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AGENDA8:00 a.m. Overview of St. Jude Medical’s 2015 growth program.
Dan Starks, Chairman, President and Chief Executive Officer
Our continued focus on returning shareholder value. Don Zurbay, Chief Financial Officer
The CardioMEMS HF System is a catalyst for 2015. Mike Rousseau, Chief Operating Officer Philip Adamson, M.D., MSc, FACC
Our neuromodulation business will return to growth in the U.S. Eric Fain, M.D., Group President
Panel for Q&A
10:00 a.m. Break
New ablation systems are another catalyst for 2015. Joel Becker, President, Americas Division
Highlights of our CRM and CV businesses. Eric Fain, M.D., Group President
Panel for Q&A
Lunch Buffet
12:30 p.m. Meeting Ends
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OVERVIEW OF ST. JUDE MEDICAL’S 2015 GROWTH PROGRAM
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ST. JUDE MEDICALMILESTONES IN 2014
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We have become “One St. Jude Medical” instead of a decentralized company organized into multiple divisions focused on different physician specialties.
Our transition from four product divisions to one streamlined organization helps us leverage our scale, reduce costs, and strengthen our focus on the new customer profile that is emerging as a result of structural changes in the health care market.
This will help us continue to leverage adjusted EPS on a constant currency basis in a growth oriented environment in 2015 and beyond.
WE COMPLETED THE REALIGNMENT OF OUR GLOBAL BUSINESS.
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We completed remediation of the FDA warning letters previously issued to our Plano and Sylmar facilities.
We improved the quality and efficiency of multiple product development capabilities that should benefit us long term.
R&D resources that were focused on warning letter remediation have been re-allocated to innovation and new products.
Results already are visible – Allure Quadra™ CRT-P, Endurity™ and Assurity™ pacemakers, Optisure™ high voltage lead, Protégé™, Prodigy™ and Proclaim™ SCS devices, Infinity™ DBS system, and more.
WE STRENGTHENED OUR QUALITY SYSTEMS AND OUR PRODUCT QUALITY.
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EndoSense™ (2H ‘13) – TactiCath™ contact force sensing ablation platform approved by FDA, Q-4 ‘14.
Nanostim™ (2H ‘13) – Nanostim leadless pacemaker is in an IDE clinical trial.
CardioMEMS™ (1H ‘14) – the first phase of product launch is underway in the U.S.
NeuroTherm™ (2H ‘14) – integration and sales force training is complete. Product line launches are underway.
WE STRENGTHENED OUR PRODUCT PORTFOLIO WITH FOUR ACQUISITIONS IN FOUR QUARTERS.
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EnligHTN™ renal denervation program – the market collapsed due to a competitor’s clinical trial failing to meet its endpoint.
Portico™ TAVR program – we temporarily suspended implants to evaluate reports of possible valve leaflet motion anomalies that turned out to be a false alarm. The impact on our program is a delay of 9 to 12 months.
In addition, we continue to await FDA clarification of regulatory approval requirements relating to LAA closure and PFO closure potential growth driver programs.
WE ABSORBED SET BACKS ON TWO MAJOR GROWTH DRIVER PROGRAMS.
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WE DELIVERED 2014 RESULTS THAT MET OR EXCEEDED THE GUIDANCE WE GAVE FOR THE YEAR IN JANUARY 2014.
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LOOKING FORWARD TO 2015
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ST. JUDE MEDICAL’S GROWTH PROGRAM IS BASED ON INNOVATION THAT HELPS REDUCE THE COST OF HEALTH CARE AND IMPROVE PATIENT OUTCOMES FOR SOME OF THE MOST EXPENSIVE, EPIDEMIC DISEASES.
Cardiac arrhythmias Heart failure Other cardiovascular disease Chronic pain Movement disorders (DBS)
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This aligns us with our customers and with all of the goals of global health care reform long term.
We can capture the virtuous cycle of innovation – (1) save customers money and improve patient care, (2) with higher ASP’s and a stronger gross margin, (3) supporting increased investment in R&D, (4) leading to more innovation and new growth drivers that accelerate sales growth, (5) while saving customers money and improving patient care.
St. Jude Medical marches to the beat of a different drummer.
AN INNOVATION BASED GROWTH PROGRAM CAN GIVE US SUSTAINABLE STRATEGIC ADVANTAGE.
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This almost always requires synergy of technology, disease state, or customer call point between the new market and one or more markets already within our portfolio.
Our CRM business provides synergy with our AF, HF, chronic pain, and DBS growth drivers.
Success in our AF, HF, chronic pain, and DBS growth drivers can help improve the economics, investment, and the competitiveness of our CRM business.
This impacts our gross margin, level of R&D investment, innovation, level of service to customers, and more.
WE ONLY ENTER MARKETS WHERE WE THINK WE HAVE A COMPETITIVE ADVANTAGE AND A CREDIBLE OPPORTUNITY TO WIN ON A SUSTAINABLE BASIS.
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OUR MARKETS FOR 2015 EXCEED $21 BILLION IN SIZE AND ARE GROWING AN AVERAGE OF 4%.
SizeMarket $ billions Growth %
Cardiac arrhythmias1 13.4 3%HF2 .1 N/AStructural Heart 3.5 10%Vascular 2.1 3%Chronic Pain3 2.0 8%DBS .5 10%
21.61 AF/CRM2 CardioMEMS only3 SCS and spinal nerve ablation
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Full year impact of CardioMEMS™.
Full year impact of new ablation catheters.
Return to growth in our neuromodulation business in the U.S.
OUR SUCCESS IN 2015 WILL BE DEFINED PRIMARILY BY OUR ABILITY TO ACCELERATE OUR SALES GROWTH DUE TO 3 CATALYSTS.
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Patient demographics, reimbursement, and overall health care economics surrounding CardioMEMS™ in the U.S. are extremely favorable.
We have no competitors.
We envision superior ROI for developing the market.
CardioMEMS™ may pull through CRM market share due to the common Merlin™ remote care platform and the other device synergies.
CardioMEMS™ revenue and product pull-through in 2H 2015 will provide good visibility for revenue growth for the U.S. in 2016 and for international markets in future years.
FULL YEAR IMPACT OF OUR CARDIOMEMS™ HF MONITORING SYSTEM.
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The AF/EP market is $3.4 billion. The ablation catheter segment alone is $1.1 billion. Both are expected to grow at a low double digit rate.
Customer preference for STJ ablation catheters will generate stand alone revenue and may help pull through our entire bundle of AF/EP products including our mapping system, introducers, diagnostic catheters, and our integrated lab.
Market share gains in 2015 can create an annuity of double digit revenue growth in 2016 and beyond in this portion of our portfolio.
FULL YEAR IMPACT OF OUR TACTICATH™ AND FLEXABILITY™ LINES OF ABLATION CATHETERS.
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New products already on the market – (1) Protégé™ SCS, (2) portfolio of spinal nerve ablation devices.
Products expected to come to the U.S. market in 2015 – (1) Invisible trial system, (2) Proclaim™ SCS, (3) iPad mini™ clinical programmer, (4) iPod touch™ patient programmer, (5) Axium™ DRG SCS system, (6) Infinity™ DBS system, (7) DBS directional lead.
We expect to exit 2015 with good visibility that our global neuromodulation revenue can continue to grow at a strong double digit rate for the foreseeable future.
RETURN TO GROWTH IN OUR NEUROMODULATION BUSINESS IN THE U.S. WILL BE DRIVEN BY A STRONG PORTFOLIO OF NEW PRODUCTS.
iPod touch and iPad mini are trademarks of Apple Inc.
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Successful launch of new products in our CRM and CV businesses.
Advance St. Jude Medical innovations in 2015 to sustain accelerated sales growth in 2016 and beyond.
Continue to leverage adjusted EPS on a constant currency basis.
Maintain the cash flow and balance sheet to continue to repurchase stock, increase our dividend, and fund disciplined acquisitions as appropriate.
OUR SUCCESS IN 2015 WILL ALSO DEPEND ON A BROAD RANGE OF OTHER ACCOMPLISHMENTS.
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OUR CONTINUED FOCUS ON RETURNING SHAREHOLDER VALUEDon Zurbay, Chief Financial Officer
DELIVERING ON OUR COMMITMENTS
Constant Currency
SalesGrowth
2014 Guidance
2014 Results
Constant CurrencyAdjusted
EPSGrowth
AdjustedGrossMargin
3-5%
6%-8%
71.5%-72.0%
9%
71.7%
4%
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Our 2015 guidance calls for constant currency sales growth of 3-5% and constant currency adjusted EPS growth of 8-10%. We are committed to continuously improving our operational
efficiency and have the opportunity to continue taking significant costs out of our business. We are continuing to expand manufacturing in cost
advantaged locations. Accelerating sales growth will provide natural leverage on our
underlying infrastructure and cost base.
WE ARE WELL POSITIONED TO CONTINUE DELIVERING EPS LEVERAGE IN 2015 AND BEYOND
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CONSISTENT GROSS MARGIN
73.1% 73.2% 73.0% - 73.5%
64.0%
66.0%
68.0%
70.0%
72.0%
74.0%
76.0%
2013 2014 2015
Adjusted Gross Margin, Excluding Foreign Currency Impact and Excise Taxes
(est.)
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Our gross margin faces headwinds from geographic and product mix shifts and lower average selling prices. We expect to offset the headwinds impacting gross margin through: Ongoing product cost improvement initiatives and benefits from the 2014
centralization of our world-wide manufacturing and supply chain organization. Consolidation of facilities and processes, leveraging suppliers, streamlining logistics,
and alignment of best practices globally.
Improved scale of our growth drivers (CardioMEMS™ HF System and ablation catheters).
Continued expansion of our manufacturing in cost advantaged locations.
We continue to advance toward our internal goal of 80% our world-wide volume in cost advantaged locations.
WE ARE WELL POSITIONED TO MAINTAIN OR IMPROVE OUR GROSS MARGIN BEYOND 2015
Adjusted SG&A expenses excluding amortization in 2014 were approximately 170 basis points lower than in 2011. Our adjusted SG&A ratios will continue to improve as we continue to
realize the benefits of centralization and accelerate our sales growth. The commercialization of our growth drivers in 2015 will require
investment in our field selling organization. 2015 guidance implies up to 50 basis points of improvement in adjusted
SG&A as a percentage of constant currency sales as we balance these investments with continued operational efficiency. The optimization of our cost structure allows us to remain committed to
our innovation-based growth strategy with our investment in R&D at approximately 12% of sales.
OPTIMIZATION OF OUR COST STRUCTURE
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ADJUSTED INCOME TAX RATE
Largest driver of our tax rate improvement is expansion of manufacturing in cost advantaged locations.
25.0%22.8% 22.4% 21.8%
19.1%17.5% - 18.5%
2010 2011 2012 2013 2014 2015 (est.)
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Balances as of January 3, 2015:
Cash on hand $1.4B
Debt outstanding $3.9B
Current credit ratings: Moody’s-Baa1, S&P-A, Fitch-A
For the five years ended 2014, we have generated cash flow from operations of approximately $6.2B.
We have ample capacity to continue returning capital to shareholders while maintaining the capacity to augment our growth strategy with disciplined acquisitions.
WE BENEFIT FROM STRONG AND CONSISTENT CASH FLOW
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DELIVERING SHAREHOLDER VALUECash Dividends
$1.1B
Adjusted Share Repurchases
$3.1B
Acquisitions and Certain
Strategic Investments
$2.3B
(9% CAGR)
($43 average share price)
2010 -2014 Capital
Deployment History
Free Cash Flow for this period is $4.9B
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Our goal is to grow constant currency sales at a 3% to 5% rate for full year 2015 and create the conditions to support sales acceleration.
We expect to continue delivering EPS leverage.
We have consistent and strong cash flow to continue to repurchase stock, increase our dividend and fund disciplined acquisitions as appropriate.
SUMMARY
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THE CARDIOMEMS™ HF SYSTEM IS A CATALYST FOR 2015Mike Rousseau, Chief Operating Officer
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1) Are we improving patient outcomes?
2) Can we help health care systems reduce costs?
3) Can we effectively develop new markets?
4) Can we scale and grow quickly?
5) Can we execute on our strategy?
LAUNCHING INNOVATION – THE QUESTIONS WE NEED TO ANSWER
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Dr. Philip Adamson: Joined St. Jude Medical in February 2015 as Vice President and Medical Director,
Heart Failure Therapies Co-Principal Investigator for CHAMPION Trial Founded the Heart Failure Treatment Program at the University of Oklahoma
in 1995 Developed a novel cardiology training curriculum designed to provide
skills in device implantation along with expertise in out-patientmultidisciplinary management
Established the Heart Failure and Pulmonary Hypertension Treatment Instituteat Oklahoma Heart Hospital in 2005
Has been closely involved in developing implantable hemodynamic monitoring systems to improve success of outpatient heart failure and pulmonary hypertension management
INTRODUCTION
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EXPERIENCE IMPLEMENTING THE CARDIOMEMS™ HF SYSTEM TECHNOLOGY Philip Adamson, MD, MSc, FACC
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Heart Failure – Epidemic and growing
5-6M Americans suffer from HF1
> 650K new heart failure diagnoses each year2,3
1M HF hospitalizations each year4
$31B in 2013, more than doubling to $70B by 20306
We need a new way to manage these patients without relying on hospitalization High re-admission rates
25% re-admission within 30 days3
50% re-admission within 6 months7
THE EXPENSIVE EPIDEMIC PROBLEM
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FDA Approved Indications The CardioMEMS™ HF System is indicated for wirelessly measuring and
monitoring pulmonary artery (PA) pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year. The hemodynamic data is used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations.
CARDIOMEMS™ HF SYSTEM – THE NEW WAY
OTHER APPROACHES HAVE BEEN EVALUATED
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COMPASS
HOMEOSTASIS
CHAMPION
Right Parameter – Pressure Right Patients – Class III Right Approach – Management to target pressures and
physician directed patient self management
Right Parameter – Pressure Right Patients – Class III Right Approach – Management to target pressures
Right Parameter – Pressure Right Patients – Class III showed significant benefit
Wrong Patients – Including Class IV resulted in no benefit Wrong Approach – Management to pressure spikes
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SUBSTANTIAL EVIDENCE SUPPORTING PA PRESSURE MONITORING IN CLASS III HF PATIENTS
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Meaningful clinical outcomes
37% reduction in HF hospital admissions at average 15 months follow-up8,
Increasing to 49% when extended to 18 months follow-up12
Safe and reliable
Patient Quality of Life aligned with Hospital Payment Priorities
58% reduction in all-cause readmissions12
78% reduction in HF 30-day readmissions12 (recently presented at AHA 2014)
Safe and effective means to reduce overall hospitalization burden and 30-day readmissions problem – maintaining stability vs. reacting to disaster
THE ONLY FDA APPROVED IMPLANTABLE SYSTEM TO MONITOR PA PRESSURE
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Diastolic or preserved Ejected Fraction (EF) (HFpEF) patients represent ~50% of all HF patients
Pulmonary Artery (PA) pressure-guided therapy significantly reduced HF hospitalizations in the treatment group by 50% and 60% at 6 and 15 months (p < 0.0001 and p < 0.0004, respectively)13
Effect in HFpEF patients even more dramatic than systolic HF patients with estimated NNT = 2
CardioMEMS™ HF System is the first effective treatment strategy to manage 50% of patients hospitalized with HF
LIMITED EFFECTIVE ALTERNATIVE FOR PRESERVED EF POPULATION
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Initial centers are already actively monitoring patients in context of disease management systems Care coordination across specialties
Managing HF patient quality of life established as priority
Infrastructure, workflow and commitment to remote monitoring
Already intensely monitoring patients
CardioMEMS™ HF System provides data with excellent and proven clinical meaning – improving established infrastructure
PROFILE OF IDEAL, INITIAL CENTER FOR CARDIOMEMS™ HF SYSTEM
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Heart failure team spends 2 to 6 weeks reviewing PA pressure waveforms to establish individual patterns, stabilize static medications, titrate pressure drugs and coach lifestyle changes through telephonic patient management or in-office evaluation
Once baseline pressures lower toward the target mean PA of 10 to 25 mm Hg10, the patient can move into the maintenance phase monitoring for positive or negative changes
HOW DOES CARDIOMEMS™ HF SYSTEM DATA FIT INTO THE EXISTING INFRASTRUCTURE
Patient Identification Implant
Lower Baseline Pressure
Maintenance
MANAGE PA PRESSURES
TITRATE MEDICATIONS
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Center success less dependent upon implant procedure and more dependent upon ongoing management of patient to pressure
Patients monitored weekly for trends
Notifications of changes to medications as needed based on variance to range
Cardiologists are well trained in the hemodynamic assessment of HF and cardiovascular disease – this is not a new mindset
HF centers have the patients – our job is to educate across the care coordination team about managing to pressure
LESSONS LEARNED FROM ONE CENTER:DEPLOYING THE TECHNOLOGY
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HF nurse practitioners and nurses within HF clinic have high degree of patient contact and are both committed to improving patient quality of life and improving own service burden
This group strongly influences technology adoption within a center given day-to-day responsibility for managing these complex and challenging patients
Initial concern may be the potential burden of data but seeing is believing
Changes in re-hospitalization and quality of life for “frequent flier patients” drive adoption
Benefits are realized quickly
THE CARE TEAM IS CRITICALLY IMPORTANT
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CARDIOMEMS™ HF SYSTEM COMMERCIALIZATIONMike Rousseau, Chief Operating Officer
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We offer improved patient outcomes and a new standard-of-care The ability to better manage patients suffering from this expensive, epidemic disease Better patient outcomes and quality of life Treat a patient population which currently has no alternative treatment (HFpEF)
TECHNOLOGY VALIDATED IN CLINICAL PRACTICE AS UNIQUE GAME CHANGING SOLUTION
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CardioMEMS™ HF System is a different sale A new paradigm of care for heart failure
Majority of implanters are ICs (~70%)
Training is focused on patient identification and managing to pressure
System sale includes sensor and patient/hospital electronics
Multiple stakeholders – each center presents new challenges
Physician and/or HF nurse champions technology within center
Internal administrative alignment required for site initiation
VALIDATED SELLING METHODOLOGY
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Rep profile is different Pharma detailing for market development vs. traditional device rep service model
More repeatable, easier to scale
Lower cost (service burden and compensation model)
Service profile is different Majority of field force is HF Specialists familiar with managing these complex patients
Teaching HF Nurses how to manage to pressure
Training to self-sufficiency
Aggressively hiring and training talent Based on pharmaceutical detailing model
HF Specialists for onboarding and training customers to manage to pressure
Accelerating contracting and onboarding process
REFINING SELLING PROCESS AND SCALING ORGANIZATION
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CMS declared CardioMEMS™ HF System a “substantial clinical improvement over existing services or technologies”
Inpatient MS-DRG 264 New Technology Add-On Payment (NTAP) granted, effective October 1, 2014
Outpatient Transitional APC Pass-Through Payment Status (TAPTS) granted, effective January 1, 2015
POSITIVE U.S. REIMBURSEMENT DECISIONS
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Procedure is relatively straightforward at ~20-30 minutes, lends itself to outpatient setting
Centers do not have to wait for HF hospital admission or consider 2-midnight rule; can proactively schedule “frequent fliers”
Appropriate reimbursement is now established within the ideal CardioMEMS™ HF System site of service
THE VALUE OF OUTPATIENT TRANSITIONAL APC PASS-THROUGH PAYMENT STATUS (TAPTS)
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CardioMEMS™ HF System
Quadra Assura™ CRT-D and Quadra Assura MP™ CRT-P: Leader and innovator in Quadripolar therapy
180-day overall costs show savings of $2,1979
Trifecta™ stented tissue valve with Linx™ AC technology: Best-in-class mean pressure gradient with Trifecta™ valve14
Remote Monitoring:
Proven benefit with remote monitoring solutions
17% reduction in total spending over 3 years ($10,640) per ICD/CRT-D patient11
9% reduction in total spending over 3 years ($4,356) per pacemaker patient11
CARDIOMEMS™ HF SYSTEM IS CORNERSTONE OF PROVEN HF FORMULARY
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2015 KEY PRIORITIES IN EXECUTING OUR STRATEGY
Strategically and opportunistically increase number of active centers Generate market awareness to drive patient flow Onboard new centers Certify through 3 proctored implants Train for and reinforce managing to pressure (ongoing, virtual)
Maximize meaningful product iterations in 2015
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Enhance Clinical Workflow
Involve Patients in Managing their Health
Create a New Dynamic in the Management of HF Patients
LEADING WITH CONTINUED INNOVATION
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CLINIC WORKFLOW ENHANCEMENTS Consolidated, centralized portal for all
patient data Trend-driven, easily actionable
Improve clinic workflow Automate phone calls/texts
Integrate data to EHR through exporting PDF
PRODUCT NOT FDA APPROVED. IDEAS UNDER DEVELOPMENT.
John Doe
Images do not reflect actual patient data.
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A NEW MODEL OF PATIENT ENGAGEMENT EXITING 2015
Connect-Rx™ technology enables automated notification to patient of prescription adjustments Improves HF clinic workflow and
efficiency by decreasing time demand of clinician-to-patient interaction by replacing phone calls Medication updates entered on website
are electronically pushed to app running on patient’s smartphone Facilitates closed-loop EHR updating of
medication changesConnect-Rx is a trademark of McKesson Corporation and/or one of its subsidiaries.
PRODUCT NOT FDA APPROVED. IDEAS UNDER DEVELOPMENT.
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$4 $12
$0
$50
$100
Q3'14A Q4'14A FY'15E
CardioMEMS™ HF System
Approx.$70
We expect 2015 sales to be approximately $70M Currently have over 90 signed
contracts Over 325 active targets in the U.S.
Work has begun to establish appropriate reimbursement in key international markets
WE ARE CONFIDENT IN OUR ABILITY TO EXECUTE IN 2015
Revenue, $M
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The health care environment has changed dramatically, requiring new approaches to cost-effective, value-added patient care
We have robust clinical evidence to support improved patient outcomes and reduced HF hospital readmissions
Hospitals, physicians, patients and payers recognize and believe in our value proposition
Selling CardioMEMS™ HF System is about treating heart failure, a highly complex and costly disease
We have learned how to sell and install CardioMEMS™ into a HF program and continue to improve, refine and replicate best practices
We are excited about our progress to date – now it is about execution
SUMMARY
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REFERENCES1. American Heart Association commends CMS proposal to expand coverage for chronic heart failure patients. http://newsroom.heart.org/news/american-heart-association-
commends-cms-proposal-to-expand-coverage-forchronic-heart-failure-patients. Accessed December 23, 2013.
2. Go AS, Mozaffarian D, Roger VL, et al. Heart disease and stroke statistics 2013 update: A report from the American Heart Association. Circulation. 2013;127(1):e6-e245.
3. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: A report of the ACC/AHA Task Force on Practice Guidelines. Circulation. 2013;128(16):1810-52.
4. Heidenreich PA, Trogdon JG, Khavjou OA, et al. Forecasting the future of cardiovascular disease in the United States: A policy statement from the American Heart Association. Circulation. 2011;123(8):933-44.
5. Blecker S, Agarwal SK, Chang PP, et al. Quality of care for heart failure patients hospitalized for any cause. J Am Coll Cardiol. 2014;63(2):123-30.
6. Costs to treat heart failure expected to more than double by 2030. http://newsroom.heart.org/news/costs-to-treat-heart-failure-expected-to-more-than-double-by-2030. Accessed April 23, 2014.
7. Hunt SA, Abraham WT, Chin MH, et al. 2009 focus update incorporated into the ACC/AHA 2005 guidelines for the diagnosis and management of heart failure in adults. Circulation. 2009;119(14):e391-479(e437).
8. Abraham WT, Adamson PB, Bourge RC, et al. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: A randomised controlled trial. Lancet. 2011;377(9766):658-66.
9. Graham CM, et al. Comparison of Healthcare Utilization and Hospital Costs for Quadripolar versus Bipolar LV Lead Technologies. HRS 2014. San Francisco, California. May 7-10, 2014.
10. Ruel M, Rubens FD, Masters RG, et al. Late incidence and predictors of persistent or recurrent heart failure in patients with aortic prosthetic valves. J Thorac Cardiovasc Surg. 2004:127(1):149-59.
11. Sutton B, et al. Improved Health Outcomes and Cost-Savings With Remote Monitoring of Cardiac Implantable Electronic Devices. HRS 2013. Denver, Colorado. May 11, 2013. PO06-54. Retrospective claims analysis of Medicare 5% sample Limited Data Set Standard Analytical Files claims and enrollment data across all manufacturers.
12. Adamson et al., Impact of Wireless Pulmonary Artery Pressure Monitoring on Heart Failure Hospitalizations and 30-Day Readmissions in Medicare-Eligible Patients with NYHA Class III Heart Failure: Results from the CHAMPION Trial AHA 2014, Chicago. Abstract 16744.
13. Adamson PB, Abraham WT, Bourge RC, et al. CardioMEMS heart sensor allows monitoring of pressures to improve outcomes in NYHA class III heart failure patients (CHAMPION) trial: Impact of hemodynamic guided care on patients with preserved ejection fraction. J Card Fail. 2010;16(11):913.
14. FDA PMA data and company IFUs.
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OUR NEUROMODULATION BUSINESS WILL RETURN TO GROWTH IN THE U.S.Eric Fain, M.D., Group President
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In 2014 STJ Neuromodulation revenue grew 25% in International vs. 5% decline in U.S. Difference in geographic performance reflects availability of new innovative products Acquired NeuroTherm™ to add radiofrequency (RF) Ablation to Chronic Pain portfolio
Approximately $2.2B market in 2015 ~$1.7B chronic pain; ~$0.5B deep brain stimulation (DBS)
Expect the 2015 global market will grow at a mid to high single digit rate on a constant currency (CC) basis
Severely underpenetrated markets Increasing stigma and negative outcomes from long-term opioid use in
chronic pain Growing evidence for improved outcomes and health care economics with
earlier intervention Significant opportunities for growth through innovation
WW NEUROMODULATION DYNAMICS
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CHRONIC PAIN
WARNING LETTER AND REMEDIATION ACTIVITIES RESULTED IN A GAP IN INNOVATION AND PRODUCT INTRODUCTIONS
>2000 2004 2008 2012 2014
2000Renew™
2001‐2002Genesis™GenesisXP
2005‐2008Eon™ EonC™
Eon Mini™
2014Protégé™ Prodigy™
2009 - 2014Warning Letter Remediation
Impact of Warning Letter: No significant product launches for approximately 6 years Loss of industry-leading innovation position Resources committed to remediation activities
2008Eon Mini™
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iPad Mini™ Clinical
Programmer
iPod touch™ Patient
Programmer
InvisibleTrial System
2015 MARKS THE RETURN TO INNOVATION WITH NEW PRODUCT PLATFORMS ACROSS ALL PRODUCT AREAS
IPG
PatientController
ClinicianProgrammer
Trial
First Upgradeable, Burst and tonic-enabled primary cell system
First Bluetooth™-enabled wireless neurostimulation system
First Apple™ iPod touch™ and iPad mini™ programming system
First Direct-connect trial system
First Implantable pulse generator (IPG) and trial systems with competitive headers
2014 2015Apple, iPod touch and iPad mini are trademarks of Apple Inc.
Bluetooth is a trademark of Bluetooth SIG, Inc.
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INVISIBLE TRIAL SYSTEM TO IMPROVE USER EXPERIENCE
Conventional Trial System
Invisible Trial System
Key Attributes Discreet (totally concealed under clothing) No cables to dislocate lead placement
during trial period Wireless, secure Bluetooth™ communication Intuitive user interface for patient controller Burst and tonic stimulation enabled Disposable, single-use headers, including
competitive lead compatibility EU: Launch 1H 2015
U.S.: Launch 2H 2015
Product Features New primary cell platform design with high
capacity batteries Sizes and shapes provides improved IPG
placement options Burst and tonic stimulation capable Magnetic resonance imaging (MRI) compatible Bluetooth™ communication to modern,
secure externals Upgradeable technology EU: Launch 1H 2015
U.S.: Launch 2H 2015Future Launches Competitive headers (2H 2015) Rechargeable models (2016)
PROCLAIM™ ADVANCED PRIMARY CELL TECHNOLOGY TO DRIVE SHARE CAPTURE
Proclaim™(HC)
Proclaim™ (LC)
Volume 39 cc 30 ccEstimated longevity 6 years 4 years
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Lateral Discriminatory Pathway
Medial Affective/Attentional
Pathway
Pain Perception
Attention to Pain
WHY BURST STIMULATION?Pain processing patterns and pathways Lateral discriminatory pathway – controls pain
perception Medial affective/attentional pathway – controls
emotional response and attention to pain stimuli
IPG stimulation patterns and pathways Low and high frequency tonic – modulates only
the lateral pathway Burst – modulates both the lateral and medial
pathways to maximize effectiveness
Communication Pattern Burst pattern mimics the natural firing patterns
of the brain for more effective modulationTonic Burst
Communication Pattern
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BURST STIMULATION PROVIDES BROAD ADVANTAGES
Attribute Benefit
Parameters within traditional ranges requiring low-moderate energy
Unlike high frequency stimulation, recharging requirements are the same as today and can be implemented in primary cell devices (~50% in international markets)
Devices provide both tonic and burst stimulation Provides options for treating evolving pain patterns post-implant
Pulse generator connectable to all lead types
May be used with percutaneous and paddle leads;potential for other anatomical targets including Dorsal Root Ganglion (DRG) and DBS
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Multiple studies with consistent results:
CLINICAL EVIDENCE GENERATION CONTINUES TO BUILD FOR EFFECTIVENESS OF BURST STIMULATION
SCS therapy success increased to more than 90% of patients1
90% patients who have received both tonic and burst prefer burst stimulation1
Paresthesia was eliminated or reduced in 95% of patients1
Burst SCS reduced Visual Analog Scale (VAS) scores* by 66.7% for tonic non-responders over 12-month period2
1. Espinet, A. Patients Reporting Moderate-Severe Pain Using Tonic Spinal Cord Stimulation Reported Mild-Moderate Pain Using Burst Stimulation. Presented at WIP Congress, Maastricht, The Netherlands, April 2014
2. Bara, et. al, First Results of Burst High Frequency Stimulation in Failed FBSS Stimulation Patients: One Year Follow Up, Neuromodulation, 20133. VanCamp T. Preliminary outcomes with a new stimulation design: Response comparison and budget impact modelling. Presented at INS Congress, Berlin, Germany, June 2013 and 4. De Ridder et. Al., A Two Center Comparative Study on Tonic Versus Burst Spinal Cord Stimulation: Amount of Responders and Amount of Pain Suppression Clinical Journal of Pain
3-4
*VAS is a validated tool used to evaluate variations in pain intensity.71
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SUNBURST IDE STUDY
Study Design
Overview Subjects randomized to Burst or tonic stimulation modes in a crossover study design
Patient Indication Intractable pain of the trunk and/or limbs
Primary Efficacy Endpoint
Change in average daily pain (VAS) between Tonic and Burst
Secondary Efficacy Endpoint
Presence of paresthesia Quality of Life
Status First patient enrollment January 2014 Enrollment completed Q4 2014 PMA Submission 2H 2015
73
DORSAL ROOT GANGLION (DRG) STIMULATION
DRGs
What is DRG Stimulation Therapy? DRG resides in the lateral recesses of the
epidural space and houses the primary sensory neurons
DRG is critical to the development and maintenance of chronic pain
Implant procedure similar to traditional SCS with access via epidural puncture and electrode placement at a different target location
Advantages of DRG Stimulation Ability to treat pain syndromes that are
typically not well served by traditional SCS Minimal postural effects Low energy requirements
(< 10% vs. traditional) Focused anatomical targeting
74
Sub-dermatomal specificity of DRG stimulation provides a focused stimulation field often confined to patient’s painful area while avoiding unwanted stimulation.
DRG STIMULATION PROVIDES FOCUSED ANATOMICAL TARGETING
Patient’s Pain
Traditional SCS
DRG
Large Area Coverage: Ideal for larger, pain complaints such as back or full leg or arm pain.
Targeted Coverage: Ideal for more specific, smaller areas of pain.
Focal: Pain in a specific area such as foot, knee, groin, hand or post-surgical location.
75
LONG-TERM INTERNATIONAL DATA DEMONSTRATES DURABILITY OF DRG STIMULATION
Stable, anatomically-specific pain relief over 12 months1
Targeting of difficult anatomical areas such as the foot1
Minimal postural effects with stable pain relief during change of position2
Stimulation covered painful areas with minimal extraneous coverage1
Improvements in Quality of Life, Function and Mood1
2 Kramer J., Liem L., Russo M., Smet I., Van Buyten J.P., Huygen F. 2014. Lack of Body Positional Effects on Paresthesias When Stimulating the Dorsal Root Ganglion(DRG) in the Treatment of Chronic Pain. Neuromodulation 2014;
1 Liem L, et al. 2014. One-Year Outcomes of Spinal Cord Stimulation of the Dorsal Root Ganglion in the Treatment of Chronic Neuropathic Pain. Neuromodulation 2014;
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STRONG DRG GROWTH IN INTERNATIONAL MARKETS
Significant adoption in Europe and Australia
DRG expands the range of pain syndromes that can be successfully treated with neurostimulation therapy
Complex regional pain syndrome (CRPS) and peripheral neuropathy market remains greatly underpenetrated (< 2%) Highest prevalence of all pain syndromes
with lowest SCS success rates High incidence of post-surgical chronic
pain syndromes$0
$5
$10
$15
$20
$25
$30
2012 2013 2014
YoY Growth ($M)
> 80% YoY
77
SPINAL MODULATION* DRG ACCURATE IDE STUDY
Study Design
Overview Subjects randomized to DRG vs. traditional SCS stimulation (Medtronic (MDT) Restore Ultra/Restore Sensor)
Patient Indication Intractable pain of the lower limbs
Primary CompositeSafety/Efficacy Endpoint
% patients with > 50% pain relief (VAS) without experiencing stimulation-induced neurological deficit
Status First patient enrollment August 2013 Follow-up completed December 2014 Premarket approval (PMA) submission January 2015 Predefined primary composite endpoint successfully met for both
non-inferiority and superiority*Spinal Modulation, Inc. (SMI) is an independent, privately-held company in which STJ has a minority equity ownership interest along with an exclusive option to acquire the company. STJ has consolidated the results of SMI as a variable interest entity since Q-2 2013.
78
Product Features Proclaim™ platform for best-in-class primary cell technology
Supported by STJ new external platforms with Bluetooth™ communication with advanced security
Small size (30 cc) with exceptional longevity (> 8 years)
MRI compatible
Burst-capable for clinical study
Leverages STJ cost structure and economies of scale
Expect submission at time of FDA approval
RAPID INTEGRATION OF DRG STIMULATION INTO NEW STJ PLATFORMS WILL ACCELERATE MARKET ADOPTION
79
RFA(NeuroTherm™)
Traditional SCS(Protégé™, Prodigy™,
Proclaim™)
DRG (SMI AXIUM, Proclaim DRG)
Cervical Spine Thoracic Spine Lumbar Spine Sacroiliac Knee Foot Shoulder Hip
Failed Back Surgery Syndrome (FBSS ) (back and leg pain)
Trunk Limbs
CRPS Extremity Groin (hernia) Testicular pain Post-surgical pain
(i.e. hip, knee, foot, etc.) Stump pain
UNMATCHED TECHNOLOGY FROM STJ: TREATING PATIENTS THROUGHOUT THE PAIN CONTINUUM
80
MOVEMENT DISORDERS
81
STJ POSITIONED TO ACCELERATE DBS GROWTHUnder Penetrated
~1% of the market served Stable long term 10%+ market growth
Market dominated by single player
Highly concentrated customer base of primarily academic-based medical professionals
~90% of patients receive primary cell systems
Opportunity for technology innovation
No innovation while under warning letter
Non-competitive primary cell devices
< 10% ID market share; not approved in US
Infrastructure and customer relationships established to take share with improved technology
Market STJ Current Status
US and EU Launch 2H 2015 for Parkinson’s and Essential Tremor Indications
2015 – INNOVATION IN DBS WITH INFINITY PLATFORM
Bluetooth™ wireless communication with advanced security Bilateral frequency control in single device Competitive headers for battery replacements Upgradable software
Thin diameter compatible with current navigation systems Robust lead design Low profile extensible extension
iPad mini™, off-the-shelf technology Bluetooth™ communications with robust security Data export to support research needs Responsive to the user, optimizing programming time
iPod touch™, off-the-shelf technology Large color intuitive interface Bluetooth™ wireless communication featuring robust security
Bold = industry firstPulse Generators
Leads and Extensions
Clinician Programmers
Patient Programmers
Apple, iPod touch and iPad mini are trademarks of Apple Inc. Bluetooth is a trademark of Bluetooth SIG, Inc. 82
83
DIRECTIONAL DBS LEAD ─ IMPROVED CONTROL OF STIMULATION FIELD FOR FOCAL ANATOMICAL TARGETING Small anatomical target structures require
precise stimulation for effective therapy while avoiding unwanted side effects
Potential advantages over traditional DBS leads: Reduced stimulation-causing side effects Decreased power requirements leading to
improved device longevity Reduced unnecessary reoperation due to lead
misplacement or migration May enable asleep lead placement
EU: Launch 2H 2015 US: Submission 2H 2015
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Warning letter is fully resolved with implementation of a strengthened quality system
We are leveraging technologies from CRM to strengthen our innovation pathway
In 2015, we will return to innovation leadership launching differentiating new platforms across all product lines
We offer an unmatched portfolio of solutions for Chronic Pain that improves therapy effectiveness and patient ease-of-use
DRG stimulation represents a large opportunity for growth from share capture and market expansion
We will have a very competitive DBS platform with innovative features that will allow us to capture meaningful share in the Movement Disorder space
We have a full product pipeline for future growth
NEUROMODULATION SUMMARY: RETURN TO GROWTH
85
86
PANEL AND Q&A
87
STJ important dates in 2015: Q1 2015 Earnings Results Conference Call April 22, 2015
Q2 2015 Earnings Results Conference Call July 22, 2015
Q3 2015 Earnings Results Conference Call October 21, 2015
BREAK
88
NEW ABLATION SYSTEMS ARE ANOTHER CATALYST FOR 2015Joel Becker, President, Americas Division
89
2015 ESTIMATED WORLDWIDE EP MARKET SIZE
Revenue in Millions AR; Growth CN
EP Ablation$1,14034%
EP Diagnostic$69020%
EP Mapping and Recording Systems
$54016%
Access $39011%
ICE/Other$2608%
ILR$38011%
2015 Market Revenue $3.4BMarket Growth: ~11%
90
EP ABLATION MARKET IS ~75% IRRIGATED/ADVANCED ABLATION
$0
$200
$400
$600
$800
$1,000
$1,200
US WWStandard Irrigated/Advanced
$1,140
$560
Revenue in Millions
US Catheter Ablation
Procedures estimated to be ~250K in 2015
Market revenue growing at 15% (’12-’15 CAGR)
STJ Market share growth from 11-17% (2014-’15)
2015 Catheter Ablation Market Size
WW Catheter Ablation
Procedures estimated to be > 990K in 2015
Market revenue growing at 13% (’12-’15 CAGR)
STJ Market share growth from 16-21% (2014-’15)
91
-
200,000
400,000
600,000
800,000
1,000,000
2012 2013 2014 2015All Other SVT AF VT
20.0% 20.9%21.1%
10.9%9.8%
9.7%
4.3%3.5%3.3%
(Sources: MRG, EHRI, Truven Health Analytics, STJ estimates)
HEALTHY BASE OF SVT PROCEDURES, WITH ATRIAL FIBRILLATION BEING THE FASTEST GROWING ABLATION SEGMENT
Growth in WW Catheter Ablation Procedures
92
GROWTH IN US CATHETER ABLATION PROCEDURES
-
50,000
100,000
150,000
200,000
250,000
300,000
2012 2013 2014 2015All Other SVT AF VT
17.6% 17.7% 17.2%
-0.7%-0.7%-1.1%
9.3%7.5%
7.4%
(Sources: MRG,Truven Health Analytics, STJ estimates)
93
EP ABLATION MARKET DYNAMICS AF procedures drive growth in total catheter ablation procedures
Growing adoption of contact force technologies for AF ablations globally Clinical evidence and adoption of technologies from Key Opinion Leaders globally
STJ ’s TactiCath™ contact force ablation catheter (second generation platform) commercially available in US and EU
Interest in mapping atrial substrates for patients with persistent AFs
VT procedures emerging with high KOL interest STAR-VT multi-centered prospective trial to address VT initiated
Procedure reimbursement is in place for major markets
STJ poised for growth Integrated product portfolio including diagnostic, imaging and mapping technologies
Advanced ablation catheter platforms
Proven clinical results
Dedicated distribution channel, current customer base
94
TactiCathTM
contact force ablation catheter
FlexAbilityTM
irrigated ablation catheter
AmpereTM
RF generator
Cool PointTM
irrigation pump
WorkMate ClarisTM
recording system
EnSite VelocityTM
mapping system
MediGuideTM
guidance system
VantageViewTM
HD display
Agilis™ NxTsteerable introducers
SwartzTM
guiding introducers
BRKTM
transseptal needles
Access and Guidance
INTEGRATED EP PRODUCT PORTFOLIO
Advanced AblationRecording Mapping and Navigation
Diagnostics and Visualization
ViewFlexTM/ViewMateTM
intracardiac ultrasound counsel
Reflexion™ spiral variable radius mapping
catheters
LiveWireTM /InquiryTM
steerable electrophysiology catheters
ResponseTM/SupremeTM
fixed diagnostic catheters
Complete Ablation Solution
95
1. Neuzil P, Reddy VY, Kautzner J, et al. Electrical reconnection after pulmonary vein isolation is contingent on contact force during initial treatment: Results from the EFFICAS I study. Circ Arrhythm Electrophysiol. 2013;6(2):327-33.
2. Reddy VY, Shah D, Kautzner J, et al.; The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study. Heart Rhythm. 2012 Nov;9(11):1789-95.3. Neuzil P, Wissner E, Kautzner J, et al. EFFICAS II Results: Contact Force, FTI, Lesion Continuity Roles at PVI. Cardiostim,June 2012, Nice, France.4. Development report number 90168493, on file based on Therapy™ Cool Flex™ Ablation Catheter Tip. 5. St. Jude Medical. Data on File. Report 90122753, on file - Based on Therapy™ Cool Flex™ Ablation Catheter Tip.6. Guerra, J. M. et al., (2013). Effects of open-irrigated radiofrequency ablation catheter design on lesion formation and complications: in vitro comparison of 6 different devices. Journal of Cardiovascular Electrophysiology,
24, 1157-1162.Criteria for “like no other” includes differentiated ablation technology characteristics: TactiCath™ Quartz: Optical (white light interferometry) sensor
technology, sampling rate of 50Hz (20ms), automatic reset for baseline management. FlexAbility™: IP for flexible tip, STJ market information regarding WW approvals of a flexible tip to perform RF ablation.
Two unique catheters that offer innovative solutions designed to ensure clinical outcomes1-3, efficient procedures and more productive EP labs.4-6
STJ OFFERS AN ADVANCED IRRIGATION CATHETER PORTFOLIO LIKE NO OTHER
FlexAbility™ ablation catheter
has a unique flexible tip for effective lesion formation, with optimal
handling for non-contact force cases.
TactiCath™ Quartz ablation catheter
pioneering technology in contact force for the treatment of
paroxysmal atrial fibrillation.
AmpereTM RF generator
is designed to provide more physician control, and higher
procedure efficiency.
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TACTICATH™ QUARTZ ABLATION CATHETER
Pioneering technology in contact force that provides accurate, reliable readings for the treatment of paroxysmal atrial fibrillation
Strong clinical evidence to support contact force TOCCATA, EFFICAS I, EFFICAS II, TOCCASTAR Real time contact force readings in any
catheter position Fiber optic sensing for accurate, reliable
measurement
Fast sampling rate for efficient workflow
No need for recalibration
97
TOCCASTAR results continue the TactiCath™ legacy with clinical evidence supporting force
CONTACT FORCE A NEW STANDARD OF CARE IN AF ABLATION
85.5%
67.7%
1. Optimal CF cohort defined as those patients where ≥ 90% lesions ≥10g2. Non-optimal CF cohort defined as those patients where < 90% lesions ≥10g3. Per protocol cohort.
Optimal CF1 vs. Non-optimal CF2 Clinically Relevant Success at 12 months
Outcomes are improved when minimum contact force recommendations of 10 grams are followed 70% lower rate of repeat ablation when
optimal CF force is used vs. non-optimal CF (p-value = 0.02) Deflectable sheath use (Agilis™) improved
protocol defined treatment success vs. fixed curve sheath (74% vs. 62.7%)3
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US TACTICATH™ QUARTZ CATHETER LAUNCH SUCCESS
FDA approval for Paroxysmal Atrial Fibrillation indication on October 27, 2014
Momentum continues to build with > 250 active TactiCath™ Quartz catheter accounts globally
Success stories coming in across all regions
Dedicated field resources to drive US market penetration
US Launch
US TaciCathTM Weekly Sales Performance
“Contact force is becoming the standard of care in ablation. The TactiCath system is unique in the large amount of clinical data indicating its effectiveness.“
- Dr Vivek Reddy
99
FLEXABILITY™ ABLATION CATHETER FDA APPROVAL FDA approval for Atrial Flutter indication on January 23, 2015
Japanese reimbursement received ahead of schedule, effective February 1, 2015
WW adoption of new flexible tip ablation platform, including Ampere™ generator has been positive
Flex tip accounted for a > 40% increase in revenue in first year of launch in ID regions (2011)
Designed with feedback from > 40 KOLs around the globe Unique flexible tip: Effective lesion formation with potentially fewer risks
Next-generation shaft technology: Reliability, accuracy and consistent performance
Advanced handle-shaft combination: Maneuverability with comfort and ease of use
Better signal quality for substrate based persistent AF and VT ablation
“The FlexAbility catheter brings technical and functional advancements to the EP lab through its unique catheter tip and excellent handling capabilities. The catheter represents an important option for electrophysiologists that are looking to broaden their ability to treat arrhythmias with increased confidence.”
- Dr . Andrea Natale
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WE PLAN TO LAUNCH A NEXT GENERATION ENSITE VELOCITYTM MAPPING SYSTEM We are not disclosing complete details for competitive reasons
Key components of the Next Generation System will include:
Robust high definition cardiac models (software)
High density automatic data acquisition combining force sensing and physiologic parameters (software)
Next generation catheter tool integration
Key benefits of the Next Generation System:
Designed for improved workflow and efficiency
Enables high density electroanatomic maps are necessary to enable substrate based mapping and therapy guidance
Designed to include more precise clinical diagnostic indices
Commercialization 2H 2015
101
STAR-VT IDE STUDY
Prospective, multi-center, randomized study using the FlexAbility™ catheter
Staged enrollment of ~1,450 patients at 50 U.S. centers and additional qualified international centers
Patients with a new ICD or a CRT-D and at high-risk of ICD shock due to monomorphic VT will be randomized 1:1 to either adjunctive treatment (ablation therapy) or control (routine drug therapy) groups
First patient enrolled December 2014
Substrate Targeted Ablation using the FlexAbility™ ablation catheter system for the Reduction of Ventricular Tachycardia (STAR-VT)
Participating centers in the U.S. are the most advanced ablation sites
National PIs:Dr. Andrea NataleDr. Frank Marchlinski
Prestigious centers include:Mayo Clinic, MGH, Duke, UCLA, Loyola, UAB, Washington Hospital, Emory, NYU, Mount Sinai (NY), Johns Hopkins, UPenn, Vanderbilt, Sanger Clinic, UCSF, Barnes Jewish, Texas Cardiac
"CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational use."
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EP PORTFOLIO IS A CATALYST FOR GROWTH IN 2015
Global AF product sales increased 11% on a constant currency basis for full year 2014
We expect growth from AF product sales to accelerate on a constant currency basis for full year 2015 due to the launch of our FlexAbility™ irrigated ablation catheter and TactiCath™ contact force ablation catheter lines
US ablation catheter sales grew 63% in Q4 2014
We expect to exit 2015 with a next generation EnSite™ Velocity™ cardiac mapping system platform and a robust pipeline of new products ready to help us sustain the superior growth of our EP portfolio in 2016 and beyond
103
104
HIGHLIGHTS OF OUR CRM AND CV BUSINESSESEric Fain, M.D., Group President
105
CARDIAC RHYTHM MANAGEMENT
106
2015 WW CRM MARKET DYNAMICS
Similar to 2014, expect the 2015 global Cardiac Rhythm Management (CRM) market to be flat to down 2% versus 2014 on a constant currency (CC) basis We expect our 2015 CRM revenue to roughly track with the WW market
on a CC basis
Our model assumes a CRM market of approximately $10-10.5B on a constant currency basis in 2015
Low, single-digit unit growth offset by pricing pressure
MRI TECHNOLOGY EVOLUTION HAS COME FULL CIRCLE Less focus on new technology as new testing methods and standards demonstrate older CRM products are MRI compatible
MRI Ready System Evolution
2008 CRM products are NOT
considered MRI compatible New technology needed
Tendril MRI™ lead
New global test standards and methods emerge, ISO technical specification 10974 published in 2012
Magnasafe* data of 1500 pts has demonstrated that special
devices and leads were unnecessary in non-thoracic
scans
IsoFlex™ Optim™ leads
Tendril ™ STS lead
Special MRI leads and pacemakers introduced with restricted scanning labelling
2015 CRM products are considered
MRI compatible based on testing New technology NOT needed
Labelling expanded to include full body
CRM Manufacturers get approval for MRI scanning with standard leads and devices
Pacing
107*Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.
108
MRI labeling a more significant driver of device choice in Japan vs. rest of world
Historically share is temporarily “borrowed” when one competitor has MRI labelling
No real differentiation within the MRI category
No new HV technology for MRI labelling – will leverage our existing Ellipse™ and Assura™ ICDs and Durata™/Optisure™ leads
Upon approval, previously implanted ICD systems will be labeled for MRI scanning
Published HV data shows strong performance of STJ ICD systems in MRI testing
MRI LANDSCAPE IN JAPAN – PACEMAKER EXPERIENCE
1H'12 2H'12 1H'13 2H'13 1H'14 2H'14
Pace
make
r Mar
ket S
hare
Impact of MRI Pacemaker Labeling on STJ Share in Japan
Competitive MRI PM launch
STJ MRI PM launch
*Q.Wang, S.Feng, C. Wen, J.Chen Magnetic resonance imaging-induced radiofrequency heating of implantable cardioverter-defibrillator leads. XVI International Symposium on Progress in Clinical Pacing, Rome 2014
109
MRI LABELED NEW PRODUCTS IN ALL SEGMENTS IN 2015
Low Voltage High Voltage CRT
Tendril™ MRI lead
Assurity™ MRI Endurity™ MRI
Ellipse™ ICD
Durata™ and Optisure™ leads
Fortify Assura™ ICD
Quadra Assura™ CRT-DQuadra Assura™ MP CRT-D
Allure Quadra™ CRT-P
Quartet™ Leads
EU: LaunchedJapan: Submitted 2H 2014
US: Submitted 2H 2014
EU: Launch 1H 2015Japan: Submit 1H 2015
US: Submit 1H 2015 (IDE)
EU: Submit 2H 2015Japan: Submit 2H 2015
US: Submit 2H 2015 (IDE)
Tendril™ STS lead
IsoFlex™ Optim™ leads
110
New platform of smaller, longer lasting MRI compatible pacemakers
Significant cost reduction over Accent MRI
Multiple models to compete successfully across price tiers
ASSURITY™ AND ENDURITY™ MRI PACEMAKERSDriving continued share capture and margin improvement with the world’s smallest, longest lasting wireless MRI pacemakers
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Have completed > 500 Nanostim™ implants worldwide
Completed enrollment/implantation of population needed for PMA submission (minimum 300 patients) in the LEADLESS II IDE Study in 2H 2014
PMA submission anticipated 2H 2015
We are in the process of reviewing data from our European Post-Market Clinical Follow-up Study with our Notified body and lead Competent Authority to evaluate and confirm effectiveness of corrective actions put in place last summer
In the meantime, we are holding off additional implants in Europe until the review is completed
MRI compatibility testing successfully completed
Dual chamber development continues to make good progress
Dual chamber pacemakers represent > 70% of worldwide pacing market
NANOSTIMTM LEADLESS PACEMAKER*
*Caution - INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.
112
STJ QUADRA ASSURA™ CRT-D SYSTEMFIRST IN QUADRIPOLAR
US CRT-D market share With new competitor entry, expect share to
follow similar trajectory of recovery as it did internationally after initial trialing CardioMEMS™ and MultiPoint™ pacing will
provide competitive differentiation going forward
STJ pioneered the standard in quadripolar More than 100,000 implants worldwide 100+ publications with strong evidence for improved clinical
outcomes and economic benefit Physician feedback indicates preference for STJ Quartet™ LV
lead handling
CRTD
Mar
ket S
hare
STJ CRT-D Share in EMEA
Competitive Quadripolar
Launch
STJ MPP Launch
2012 Q4 2013 Q1 2013 Q2 2013 Q3 2013 Q4
STJ CRM/CARDIOMEMS™ HF SYSTEM COMBINATION PROVIDES MORE COMPLETE HF DIAGNOSTICS
STJ ICD/CRT-D with CardioMEMS™ Competitor ICD/CRT-D with CardioMEMS™
Only use of STJ CRM devices provide: Time based alignment and integration of CMEMS
PAP data and STJ ICD/CRT device diagnostics (including VT/VF, AT/AF, Activity, Heart Rate and % pacing)
Improved clinic workflow and efficiency; need to visit only one website and view one report
Provides clinical and efficiency reasons to select STJ device at the time of box change
Expect to launch 1H 2015113
1. Ypenburg C, van Bommel RJ, Borleffs CJ, et al. Long-term prognosis after cardiac resynchronization therapy is related to the extent of left ventricular reverse remodeling atmidterm follow-up. J Am Coll Cardiol. 2009;53(6):483-90.2. Rinaldi et al. Acute hemodynamic benefits of multisite LV pacing in CRT recipients. Abstract ACC 20123. Thibault et al. Acute haemodynamic comparison of multisite and biventricular pacing with a quadripolar LV lead. Europace 2013 ;15:984-9914. Pappone et al. Multipoint LV pacing improves acute hemodynamic response assessed with pressure-volume loops in CRT patients. Heart Rhythm 2014;11(3):394-4015. Rinaldi et al. Acute effects of multisite LV pacing on mechanical dyssynchrony in patients receiving CRT. J Cardiac Failure 2013;19:731-7386. Pappone, et al. Multipoint left ventricular pacing in a single coronary sinus branch improves 12-month response to cardiac resynchronization therapy. ESC 2014 (abstract).7. Cuko et al. Multipoint LV pacing provides additional echo benefit to responders and non-responders to CRT. XVI International Symposium on Progress in Clinical Pacing 20148. Pappone C, et al. Improvement in 3-month echocardiographic response with multisite left ventricular pacing in cardiac resynchronization therapy patients. HRS 2013 Postersession PO02. May 9, 2013.
MULTIPOINT™ PACINGEXCLUSIVE APPROACH TO IMPROVING PATIENT RESPONSE TO CRT THERAPYMeeting an important unmet clinical need Many CRT patients do not respond to CRT therapy1
Non-responders cannot be identified at time of implantMultiPoint™ pacing Exclusive STJ solution Non-invasive toolset using STJ quadripolar technology Improved responder rate should translate into economic
benefitClinical evidence for MPP continues to build Improved acute hemodynamics2,3,4,5
RCT demonstrated sustained chronic improvement at 12 months with a 19% absolute increase in responder rates and 44% reduction in non-responder rate6
Commercial and Clinical Status Majority of STJ quadripolar devices sold in Europe are now MultiPoint™ pacing devices with an
increase in ASP US IDE enrollment completed 2H 2014 Expect FDA submission 2H 2015
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QUADRA ALLURE™ CRT-PLEADERSHIP IN FASTEST GROWING CRM SEGMENT
Strong demand driving double digit share capture in fastest growing CRM segment
Exited 2014 with > 50% US de novo share
Continued clinical evidence leading to market growth, appealing to pacer implanters who begin implanting CRT-P
U.S. Centers for Medicare and Medicaid Services (CMS) reimbursement increased 55% effective January 1, 2015
Significant competitive advantage with quadripolar technology and now MultiPoint™ pacing available (International)
Leverages new low voltage platform for improved cost structure, longevity and size
$200
$300
$400
2012 2013 2014 2015$M
M
Estimated CRT-P Market Revenue
WW Market Size
8% CAGR
115
116
SUMMARY OF CRM HIGHLIGHTS FOR 2015
The global CRM market has mostly stabilized
We will have new MRI labeled device submissions and launches across all CRM product segments
We continue to strengthen and grow our low voltage product portfolio
We continue to be the leaders in Quadripolar technology with MultiPoint™ pacing, Quadra Allure MP™ CRT-P and product synergies with CardioMEMS™ HF System
117
CARDIOVASCULAR
118
$0
$500
$1,000
$1,500
$2,000
$2,500
$3,000
2014 2015 2016 2017 2018 2019W
W M
arke
t Rev
enue
($M)
2% of the population ages 65 or older have moderate to severe aortic stenosis
6 million people worldwide suffer from severe aortic stenosis (diagnosed prevalence)
Expectation that intermediate risk patients will be treated with TAVR technology
Without treatment, half of symptomatic aortic stenosis patients will die within 2 years
WW TAVR Market
*Projected
GROWING WORLDWIDE TAVR MARKET OPPORTUNITY
119
PORTICO™ VALVE ADVANCED FEATURES
*All sizes remain investigational in the U.S. and not available for sale. Sizes 27 and 29 remain investigational in EU and not for sale.
Non-flared annulus section of stent frame and optimal valve height designed to mitigate conduction disturbances
Bovine pericardium leafletswith porcine pericardium sealing cuff to reduce PV leak
23, 25, 27 and 29 mm sizes*
Large cell geometry allows tissue to conform around calcific nodules to minimize PV leak
Portico™ TAVR technology contains key product features desired in latest generation devices.
Multiple access sites: transfemoral, transaortic, subclavian and transapical
Unique Nitinol properties allows valve to be fully repositioned and retrieved in situ until fully deployed for accurate placement
PORTICO™ PERFORMANCE COMPARES FAVORABLY WITH LATEST GENERATION DEVICES
30-Day Results*
Portico™1
N=103
CoreValve™2
(US Pivotal Extreme Risk)
N=471
Sapien™ XT3
(PARTNER II)N=276
Sapien™ 4
N=96Direct Flow™5
N=100Lotus™ Valve6
N=120
Death 2.9% 7.9% 3.5% 2.1% 1.3% 4.2%
Stroke(Disabling) 2.9% 2.4% 3.2% 0.0% 4.0% 1.7%
New Pacemaker 9.7% 22.2% 6.4% 12.5% 17.0% 28.6%
MI 1.9% 1.3% 1.8% 2.1% 1.3% 3.3%
Major Vascular Complications 5.8% 8.3% 9.6% 5.2% 2.7% 2.5%
Disabling Bleeding 3.9% 11.7% 7.8% 2.1% 2.7% 5.0%
Mean Gradient 8.8 mmHg 8.5 mmHg 10 mmHg 10.7 mmHg 12.5 mmHg 11.5 mmHg
PVL (Mod/Severe) 4.0% 11.5% 24.2% 2.6% 2.0% 1.0%*Trials are not head-to-head comparisons but reflect individual studies
1. Manoharan, G. Portico CE Trial Assessment of the St. Jude Medical Portico™ Transcatheter Aortic Valve Implant and the Transfemoral Delivery System. TCT 2014. 2. Popma J. CoreValve US Pivotal Extreme Risk Iliofemoral Study Results. TCT 2013. 3. Leon, M. A Randomized Evaluation of the SAPIEN XT in Patients with AS Who Are Not Candidates for Surgery: PARTNER II, Inoperable Cohort, ACC 2013. 4. Webb, J. 30-Day Outcomes from the Sapien 3 Trial. EuroPCR May 2014. Results for TF cohort.5. Shofer, J. Prospective, multicenter evaluation of the Direct Flow Medical transcatheter aortic valve: the DISCOVER trial 6-month follow-up. TCT 2013. 6. Meredith I. REPRISE II: A Prospective Registry Study of Transcatheter Aortic Valve Replacement with a Repositionable Transcatheter Heart Valve in Patients with Severe Aortic Stenosis. TCT 2013.Sapien 3 and Sapien XT are trademarks of Edwards Lifesciences Corporation. CoreValve is a trademark of Medtronic CV Luxembourg S.A.R.L. Lotus is a trademark of Boston Scientific Corporation. Direct Flow is a trademark of Direct Flow Medical.
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FDA discussions ongoing Resumption of US IDE Study:
Expected 1H 2015 Complete activation of all 40 US IDE
sites: Expected 2H 2015 Expect return to rapid enrollment
upon restart
Resumption of 27/29 mm CE mark studies: 1H 2015 Resumption of commercial 23/25 mm implants in OUS markets: Expected 1H 2015 Commercial availability of full range of transfemoral sizes 23/25/27/29 mm: Expected 2H 2015
US ACTIVITIES
INTERNATIONAL ACTIVITIES
PORTICO™ FOCUS IN 2015Monthly US IDE Enrollment Prior to Pause
0
10
20
30
40
50
60
May June July AugustEnrolling Sites: 2 3 4 10
Patie
nts pe
r Mon
th
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Strong international adoption of LAA Occlusion continues STJ grew faster than the market in 2014 Recently improved reimbursement in European markets STJ strength with EP and IC physicians is well suited to
LAA Occlusion
Next generation AMULET™ improves upon an already successful AMPLATZER™ Cardiac Plug (ACP) Enhanced delivery system and workflow (pre-loaded) Addresses a broader range of patient anatomies Full launch underway 1H 2015 in Europe and Australia Positive feedback and strong product adoption
at launch Awaiting FDA decision on competitor’s device to decide
on US strategy
AMPLATZER™ AMULET™ BUILDS UPON THE AMPLATZER™ CARDIAC PLUG SUCCESS
*2015 Projected
$0
$30
$60
$90
2011 2012 2013 2014 2015*
OU
S M
arke
t Rev
enue
($M
)
LAA Occlusion Market – International
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FFR MARKET IS UNDERPENETRATED AND GROWING STJ is the WW market leader
FFR market remains underpenetrated
Wireless PressureWire™ FFR is the gold standard
For physicians that stage with resting indices, Pd/Pa allows for an adenosine-free option that is at least as accurate as other resting indices
New Pd/Pa software upgrade available 1H 2015
*2015 Projected
$0
$200
$400
2011 2012 2013 2014 2015*
WW FFR Market
WW
Mar
ket R
even
ue ($
M)
124
OCT MARKET IS UNDERPENETRATED AND GROWING STJ is the WW market leader OCT Market continues to see strong growth at
the expense of intravascular ultrasound (IVUS) New Dragonfly™ OPTIS™ imaging catheter for
enhanced workflow Redesigned tip for improved tracking Continuous calibration for reduced procedural
time US, EU, Japan launch: 1H 2015
*2015 Projected
$0
$50
$100
$150
2011 2012 2013 2014 2015*
WW OCT Market
WW
Mar
ket R
even
ue ($
M)
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OPTIS™ INTEGRATED SYSTEM:FFR AND OCT WITH REAL-TIME ANGIO CO-REGISTRATION
FFR and OCT are now “always there and always on” …built into the cath lab angiography system
Real-time co-registration of OCT and Angio image
Supports both OCT and FFR in a single system
Identifies important vessel characteristics that cannot be seen with Angio or IVUS
US, EU launch: 1H 2015 Japan launch: 2H 2015
“With Optis Integrated, I know, without question, exactly where I am and what I am looking at…” - Interventional Cardiologist
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CV SUMMARY
STJ has invested in the segments of the Cardiovascular space that are expected to show strong double digit growth for a number of years: TAVR – Portico™
LAA Occlusion – Amplatzer™ Amulet™
FFR – PressureWire™
OCT – OPTIS™ integrated system with Dragonfly™ OPTIS™ catheters
Hemodynamic Monitoring for HF – CardioMEMS™
Our innovative product portfolio provides improved workflow, decreased overall costs and improved patient outcomes
We expect that our cardiovascular business will continue to grow at a high single digit or low double digit rate in 2015
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128
PANEL AND Q&A
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THIS CONCLUDES OUR MEETING. THANK YOU FOR YOUR CONTINUED
INTEREST IN ST. JUDE MEDICAL.