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ST. JUDE MEDICAL 2015
INVESTOR CONFERENCE
February 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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AGENDA
8:00 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 MEDICAL
MILESTONES 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%.
Size
Market $ billions Growth %
Cardiac arrhythmias1 13.4 3%
HF2 .1 N/A
Structural Heart 3.5 10%
Vascular 2.1 3%
Chronic Pain3 2.0 8%
DBS .5 10%
21.6
1 AF/CRM
2 CardioMEMS only
3 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 VALUE
Don Zurbay, Chief Financial Officer
DELIVERING ON OUR COMMITMENTS
Constant
Currency
Sales
Growth
2014
Guidance
2014
Results
Constant
Currency
Adjusted
EPS
Growth
Adjusted
Gross
Margin
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 VALUE
Cash 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 2015
Mike 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-patient
multidisciplinary management
 Established the Heart Failure and Pulmonary Hypertension Treatment Institute
at 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
X
X
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
COMMERCIALIZATION
Mike 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 changes
Connect-Rx is a trademark of McKesson Corporation and/or one of its subsidiaries.
PRODUCT NOT FDA APPROVED. IDEAS UNDER DEVELOPMENT.
58
$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
60
REFERENCES
1. 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 Asso ciation. 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 Ta sk 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 polic y 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 Card iol. 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 ma nagement 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 rando mised 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 da ta 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.
61
62
OUR NEUROMODULATION
BUSINESS WILL RETURN
TO GROWTH IN THE U.S.
Eric Fain, M.D., Group President
63
 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
64
CHRONIC PAIN
WARNING LETTER AND REMEDIATION ACTIVITIES RESULTED
IN A GAP IN INNOVATION AND PRODUCT INTRODUCTIONS
>2000 2004 2008 2012 2014
2000
Renew™
2001-2002
Genesis™
GenesisXP
2005-2008
Eon™
EonC™
Eon Mini™
2014
Protégé™
Prodigy™
2009 - 2014
Warning 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
2008
Eon Mini™
65
66
iPad Mini™
Clinical
Programmer
iPod touch™
Patient
Programmer
Invisible
Trial System
2015 MARKS THE RETURN TO INNOVATION WITH NEW
PRODUCT PLATFORMS ACROSS ALL PRODUCT AREAS
IPG
Patient
Controller
Clinician
Programmer
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 2015
Apple, iPod touch and iPad mini are trademarks of Apple Inc.
Bluetooth is a trademark of Bluetooth SIG, Inc.
67
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 2015
Future 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 cc
Estimated
longevity
6 years 4 years
68
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 modulation
Tonic Burst
Communication
Pattern
69
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 70
 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, 2013
3. 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
72
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;
76
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 Composite
Safety/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 GROWTH
Under 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
84
 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 2015
Joel Becker, President, Americas Division
89
2015 ESTIMATED WORLDWIDE EP MARKET SIZE
Revenue in Millions AR; Growth CN
EP Ablation
$1,140
34%
EP Diagnostic
$690
20%
EP Mapping and
Recording Systems
$540
16%
Access
$390
11%
ICE/Other
$260
8%
ILR
$380
11%
2015 Market Revenue $3.4B
Market Growth: ~11%
90
EP ABLATION MARKET IS ~75% IRRIGATED/ADVANCED
ABLATION
$0
$200
$400
$600
$800
$1,000
$1,200
US WW
Standard 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 2015
All 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 2015
All 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™ NxT
steerable introducers
SwartzTM
guiding introducers
BRKTM
transseptal needles
Access and
Guidance
INTEGRATED EP PRODUCT PORTFOLIO
Advanced Ablation
Recording Mapping
and Navigation
Diagnostics and
Visualization
ViewFlexTM/ViewMateTM
intracardiac ultrasound console
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.
96
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 ≥10g
2. Non-optimal CF cohort defined as those patients where < 90% lesions ≥10g
3. 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
98
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
100
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 Natale
Dr. 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."
102
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 BUSINESSES
Eric 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
PacemakerMarketShare
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 Magneticresonance imaging-inducedradiofrequencyheating of implantablecardioverter-defibrillator leads. XVI
International Symposiumon Progress in ClinicalPacing, 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-D
Quadra Assura™ MP
CRT-D
Allure Quadra™ CRT-P
Quartet™ Leads
EU: Launched
Japan: Submitted 2H 2014
US: Submitted 2H 2014
EU: Launch 1H 2015
Japan: Submit 1H 2015
US: Submit 1H 2015 (IDE)
EU: Submit 2H 2015
Japan: 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 PACEMAKERS
Driving continued share capture and margin improvement with the world’s smallest,
longest lasting wireless MRI pacemakers
111
 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 SYSTEM
FIRST 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
CRTDMarketShare
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 2015
113
1. Ypenburg C, van Bommel RJ, Borleffs CJ, et al. Long-term prognosis after cardiac resynchronizationtherapy is related to the extent of left ventricular reverse remodelingatmidtermfollow-up. J Am Coll Cardiol. 2009;53(6):483-90.
2. Rinaldi et al. Acute hemodynamicbenefitsof multisite LV pacing in CRT recipients. Abstract ACC 2012
3. Thibault et al. Acute haemodynamiccomparisonof multisiteand biventricular pacing with a quadripolar LV lead. Europace 2013 ;15:984-991
4. Pappone et al. Multipoint LV pacing improvesacute hemodynamicresponse assessed with pressure-volumeloops in CRT patients. Heart Rhythm 2014;11(3):394-401
5. Rinaldiet al. Acute effectsof multisiteLV pacing on mechanical dyssynchronyin patientsreceivingCRT. J Cardiac Failure 2013;19:731-738
6. Pappone, et al. Multipoint left ventricular pacing in a single coronary sinus branch improves 12-month response to cardiac resynchronizationtherapy. ESC 2014 (abstract).
7. Cuko et al. Multipoint LV pacing provides additionalecho benefit to responders and non-responders to CRT. XVI InternationalSymposium on Progress in ClinicalPacing 2014
8. Pappone C, et al. Improvement in 3-month echocardiographicresponse with multisiteleft ventricular pacing in cardiac resynchronization therapy patients. HRS 2013 PostersessionPO02. May 9, 2013.
MULTIPOINT™ PACING
EXCLUSIVE APPROACH TO IMPROVING PATIENT RESPONSE TO CRT THERAPY
Meeting an important unmet clinical need
 Many CRT patients do not respond to CRT therapy1
 Non-responders cannot be identified at time of implant
MultiPoint™ pacing
 Exclusive STJ solution
 Non-invasive toolset using STJ quadripolar technology
 Improved responder rate should translate into economic
benefit
Clinical 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
114
QUADRA ALLURE™ CRT-P
LEADERSHIP 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
$MM
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
$3,000
2014 2015 2016 2017 2018 2019
WWMarketRevenue($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 leaflets
with 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=96
Direct Flow™5
N=100
Lotus™ 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.
121
 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 2015
Monthly US IDE Enrollment Prior to Pause
0
10
20
30
40
50
60
May June July August
Enrolling Sites: 2 3 4 10
PatientsperMonth
122
 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
$90
2011 2012 2013 2014 2015*
OUSMarketRevenue($M)
LAA Occlusion Market – International
123
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
$400
2011 2012 2013 2014 2015*
WW FFR Market
WWMarketRevenue($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
$150
2011 2012 2013 2014 2015*
WW OCT Market
WWMarketRevenue($M)
125
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
126
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
127
128
PANEL AND Q&A
129
THIS CONCLUDES OUR MEETING.
THANK YOU FOR YOUR CONTINUED
INTEREST IN ST. JUDE MEDICAL.

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2015 investor's meeting consolidated slide deck final

  • 1. 1 ST. JUDE MEDICAL 2015 INVESTOR CONFERENCE February 6, 2015
  • 2. 2 WELCOME AND OPENING REMARKS Dan Starks, Chairman, President and CEO
  • 3. 3 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
  • 4. 4 AGENDA 8:00 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
  • 5. 5 OVERVIEW OF ST. JUDE MEDICAL’S 2015 GROWTH PROGRAM
  • 7. 7  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.
  • 8. 8  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.
  • 9. 9  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.
  • 10. 10  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.
  • 11. 11 WE DELIVERED 2014 RESULTS THAT MET OR EXCEEDED THE GUIDANCE WE GAVE FOR THE YEAR IN JANUARY 2014.
  • 13. 13 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)
  • 14. 14  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.
  • 15. 15  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.
  • 16. 16 OUR MARKETS FOR 2015 EXCEED $21 BILLION IN SIZE AND ARE GROWING AN AVERAGE OF 4%. Size Market $ billions Growth % Cardiac arrhythmias1 13.4 3% HF2 .1 N/A Structural Heart 3.5 10% Vascular 2.1 3% Chronic Pain3 2.0 8% DBS .5 10% 21.6 1 AF/CRM 2 CardioMEMS only 3 SCS and spinal nerve ablation
  • 17. 17  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.
  • 18. 18  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.
  • 19. 19  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.
  • 20. 20  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.
  • 21. 21  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.
  • 22. 22 OUR CONTINUED FOCUS ON RETURNING SHAREHOLDER VALUE Don Zurbay, Chief Financial Officer
  • 23. DELIVERING ON OUR COMMITMENTS Constant Currency Sales Growth 2014 Guidance 2014 Results Constant Currency Adjusted EPS Growth Adjusted Gross Margin 3-5% 6%-8% 71.5%-72.0% 9% 71.7% 4% 23
  • 24. 24  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
  • 25. 25 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.)
  • 26. 26  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
  • 27.  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 27
  • 28. 28 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.)
  • 29. 29  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
  • 30. 30 DELIVERING SHAREHOLDER VALUE Cash 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
  • 31. 31  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
  • 32. 32
  • 33. 33 THE CARDIOMEMS™ HF SYSTEM IS A CATALYST FOR 2015 Mike Rousseau, Chief Operating Officer
  • 34. 34 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
  • 35. 35  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-patient multidisciplinary management  Established the Heart Failure and Pulmonary Hypertension Treatment Institute at 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
  • 36. 36 EXPERIENCE IMPLEMENTING THE CARDIOMEMS™ HF SYSTEM TECHNOLOGY Philip Adamson, MD, MSc, FACC
  • 37. 37  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
  • 38. 38 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
  • 39. OTHER APPROACHES HAVE BEEN EVALUATED 39
  • 40. 40 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 X X SUBSTANTIAL EVIDENCE SUPPORTING PA PRESSURE MONITORING IN CLASS III HF PATIENTS
  • 41. 41  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
  • 42. 42  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
  • 43. 43  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
  • 44. 44  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
  • 45. 45  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
  • 46. 46  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
  • 47. 47 CARDIOMEMS™ HF SYSTEM COMMERCIALIZATION Mike Rousseau, Chief Operating Officer
  • 48. 48 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
  • 49. 49  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
  • 50. 50  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
  • 51. 51  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
  • 52. 52  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)
  • 53. 53  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
  • 54. 54 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
  • 55. 55 Enhance Clinical Workflow Involve Patients in Managing their Health Create a New Dynamic in the Management of HF Patients LEADING WITH CONTINUED INNOVATION
  • 56. 56 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.
  • 57. 57 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 changes Connect-Rx is a trademark of McKesson Corporation and/or one of its subsidiaries. PRODUCT NOT FDA APPROVED. IDEAS UNDER DEVELOPMENT.
  • 58. 58 $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
  • 59. 59  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
  • 60. 60 REFERENCES 1. 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 Asso ciation. 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 Ta sk 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 polic y 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 Card iol. 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 ma nagement 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 rando mised 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 da ta 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.
  • 61. 61
  • 62. 62 OUR NEUROMODULATION BUSINESS WILL RETURN TO GROWTH IN THE U.S. Eric Fain, M.D., Group President
  • 63. 63  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
  • 65. WARNING LETTER AND REMEDIATION ACTIVITIES RESULTED IN A GAP IN INNOVATION AND PRODUCT INTRODUCTIONS >2000 2004 2008 2012 2014 2000 Renew™ 2001-2002 Genesis™ GenesisXP 2005-2008 Eon™ EonC™ Eon Mini™ 2014 Protégé™ Prodigy™ 2009 - 2014 Warning 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 2008 Eon Mini™ 65
  • 66. 66 iPad Mini™ Clinical Programmer iPod touch™ Patient Programmer Invisible Trial System 2015 MARKS THE RETURN TO INNOVATION WITH NEW PRODUCT PLATFORMS ACROSS ALL PRODUCT AREAS IPG Patient Controller Clinician Programmer 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 2015 Apple, iPod touch and iPad mini are trademarks of Apple Inc. Bluetooth is a trademark of Bluetooth SIG, Inc.
  • 67. 67 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
  • 68. 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 2015 Future 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 cc Estimated longevity 6 years 4 years 68
  • 69. 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 modulation Tonic Burst Communication Pattern 69
  • 70. 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 70
  • 71.  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, 2013 3. 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
  • 72. 72 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. 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. 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. 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;
  • 76. 76 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. 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 Composite Safety/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. 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. 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
  • 81. 81 STJ POSITIONED TO ACCELERATE DBS GROWTH Under 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
  • 82. 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. 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
  • 84. 84  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. 85
  • 87. 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. 88 NEW ABLATION SYSTEMS ARE ANOTHER CATALYST FOR 2015 Joel Becker, President, Americas Division
  • 89. 89 2015 ESTIMATED WORLDWIDE EP MARKET SIZE Revenue in Millions AR; Growth CN EP Ablation $1,140 34% EP Diagnostic $690 20% EP Mapping and Recording Systems $540 16% Access $390 11% ICE/Other $260 8% ILR $380 11% 2015 Market Revenue $3.4B Market Growth: ~11%
  • 90. 90 EP ABLATION MARKET IS ~75% IRRIGATED/ADVANCED ABLATION $0 $200 $400 $600 $800 $1,000 $1,200 US WW Standard 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. 91 - 200,000 400,000 600,000 800,000 1,000,000 2012 2013 2014 2015 All 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. 92 GROWTH IN US CATHETER ABLATION PROCEDURES - 50,000 100,000 150,000 200,000 250,000 300,000 2012 2013 2014 2015 All 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. 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. 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™ NxT steerable introducers SwartzTM guiding introducers BRKTM transseptal needles Access and Guidance INTEGRATED EP PRODUCT PORTFOLIO Advanced Ablation Recording Mapping and Navigation Diagnostics and Visualization ViewFlexTM/ViewMateTM intracardiac ultrasound console Reflexion™ spiral variable radius mapping catheters LiveWireTM /InquiryTM steerable electrophysiology catheters ResponseTM/SupremeTM fixed diagnostic catheters Complete Ablation Solution
  • 95. 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.
  • 96. 96 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. 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 ≥10g 2. Non-optimal CF cohort defined as those patients where < 90% lesions ≥10g 3. 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
  • 98. 98 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. 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
  • 100. 100 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. 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 Natale Dr. 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."
  • 102. 102 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. 103
  • 104. 104 HIGHLIGHTS OF OUR CRM AND CV BUSINESSES Eric Fain, M.D., Group President
  • 106. 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
  • 107. 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. 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 PacemakerMarketShare 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 Magneticresonance imaging-inducedradiofrequencyheating of implantablecardioverter-defibrillator leads. XVI International Symposiumon Progress in ClinicalPacing, Rome 2014
  • 109. 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-D Quadra Assura™ MP CRT-D Allure Quadra™ CRT-P Quartet™ Leads EU: Launched Japan: Submitted 2H 2014 US: Submitted 2H 2014 EU: Launch 1H 2015 Japan: Submit 1H 2015 US: Submit 1H 2015 (IDE) EU: Submit 2H 2015 Japan: Submit 2H 2015 US: Submit 2H 2015 (IDE) Tendril™ STS lead IsoFlex™ Optim™ leads
  • 110. 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 PACEMAKERS Driving continued share capture and margin improvement with the world’s smallest, longest lasting wireless MRI pacemakers
  • 111. 111  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. 112 STJ QUADRA ASSURA™ CRT-D SYSTEM FIRST 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 CRTDMarketShare STJ CRT-D Share in EMEA Competitive Quadripolar Launch STJ MPP Launch 2012 Q4 2013 Q1 2013 Q2 2013 Q3 2013 Q4
  • 113. 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 2015 113
  • 114. 1. Ypenburg C, van Bommel RJ, Borleffs CJ, et al. Long-term prognosis after cardiac resynchronizationtherapy is related to the extent of left ventricular reverse remodelingatmidtermfollow-up. J Am Coll Cardiol. 2009;53(6):483-90. 2. Rinaldi et al. Acute hemodynamicbenefitsof multisite LV pacing in CRT recipients. Abstract ACC 2012 3. Thibault et al. Acute haemodynamiccomparisonof multisiteand biventricular pacing with a quadripolar LV lead. Europace 2013 ;15:984-991 4. Pappone et al. Multipoint LV pacing improvesacute hemodynamicresponse assessed with pressure-volumeloops in CRT patients. Heart Rhythm 2014;11(3):394-401 5. Rinaldiet al. Acute effectsof multisiteLV pacing on mechanical dyssynchronyin patientsreceivingCRT. J Cardiac Failure 2013;19:731-738 6. Pappone, et al. Multipoint left ventricular pacing in a single coronary sinus branch improves 12-month response to cardiac resynchronizationtherapy. ESC 2014 (abstract). 7. Cuko et al. Multipoint LV pacing provides additionalecho benefit to responders and non-responders to CRT. XVI InternationalSymposium on Progress in ClinicalPacing 2014 8. Pappone C, et al. Improvement in 3-month echocardiographicresponse with multisiteleft ventricular pacing in cardiac resynchronization therapy patients. HRS 2013 PostersessionPO02. May 9, 2013. MULTIPOINT™ PACING EXCLUSIVE APPROACH TO IMPROVING PATIENT RESPONSE TO CRT THERAPY Meeting an important unmet clinical need  Many CRT patients do not respond to CRT therapy1  Non-responders cannot be identified at time of implant MultiPoint™ pacing  Exclusive STJ solution  Non-invasive toolset using STJ quadripolar technology  Improved responder rate should translate into economic benefit Clinical 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 114
  • 115. QUADRA ALLURE™ CRT-P LEADERSHIP 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 $MM Estimated CRT-P Market Revenue WW Market Size 8% CAGR 115
  • 116. 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
  • 118. 118 $0 $500 $1,000 $1,500 $2,000 $2,500 $3,000 2014 2015 2016 2017 2018 2019 WWMarketRevenue($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. 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 leaflets with 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
  • 120. 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=96 Direct Flow™5 N=100 Lotus™ 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.
  • 121. 121  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 2015 Monthly US IDE Enrollment Prior to Pause 0 10 20 30 40 50 60 May June July August Enrolling Sites: 2 3 4 10 PatientsperMonth
  • 122. 122  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 $90 2011 2012 2013 2014 2015* OUSMarketRevenue($M) LAA Occlusion Market – International
  • 123. 123 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 $400 2011 2012 2013 2014 2015* WW FFR Market WWMarketRevenue($M)
  • 124. 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 $150 2011 2012 2013 2014 2015* WW OCT Market WWMarketRevenue($M)
  • 125. 125 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
  • 126. 126 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
  • 127. 127
  • 129. 129 THIS CONCLUDES OUR MEETING. THANK YOU FOR YOUR CONTINUED INTEREST IN ST. JUDE MEDICAL.