healthcare conference - boston scientific/media/... · •multiple launches into $13b of new market...
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Credit Suisse 26th Annual
Healthcare Conference
Joe Fitzgerald, EVP and President, Rhythm Management
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Safe Harbor for Forward-Looking Statements
and Regulatory Disclaimers
This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could differ materially from the expectations and projections expressed or implied by our forward-looking statements.
Factors that may cause such differences can be found in our most recent Form 10-K and Forms 10-Q filed or to be filed with the Securities and Exchange Commission under the headings “Risk Factors” and “Safe Harbor for Forward-Looking Statements.” Accordingly, you are cautioned not to place undue reliance on any of our forward-looking statements. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which they may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.
Market Estimates:
Unless noted otherwise, all references to market sizes, market share positions, and market growth rates are BSX internal estimates.
Regulatory Disclaimers:
Insertable Cardiac Monitor is an investigational device in the United States and not available for sale.
Modular CRM, Apama RF Balloon Catheter System, Direct Sense, and Force Sensing technologies are not available for use or sale in the United States.
*Non-GAAP measure; for reconciliations of non-GAAP financial measures to the most directly comparable GAAP figures, please refer to pages 18-21 of this document.
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What to Expect from BSX
1. Living BSX values
• Transforming patients’ lives through meaningful innovation and a “WINNING SPIRIT”
2. Driving category leadership and expanding globally
• Gaining share globally: Portfolio innovation & compelling economic value drivers
• Emerging markets: Building scale & new capabilities to increase patient access
3. Enhancing long term outlook: entering into multiple large, high-growth markets
• Diversifying into large high-growth markets with differentiated portfolio & capabilities
• Multiple launches into $13B of new market opportunities
4. Consistently delivering revenue and EPS growth in top tier of peer group
• 2015-2017E: 3 year organic revenue* CAGR +7% and EPS CAGR +14-15%
• 2018E-2020E: 3 year organic revenue* CAGR +6-8% and EPS CAGR +DD
5. Building shareholder value with disciplined capital allocation strategy: more to come
• Strong free cash flow* generation: estimated $6.5B+ cumulative in years 2018-2020
• Rigorous and balanced approach to M&A
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Interventional
Cardiology
Neuromodulation
Endoscopy
Urology and
Pelvic Health
Rhythm Management
CRM Electrophysiology
$2.3B, +13%
$560M, +12%
$1.0B, +45%
(+14% ex. AMS)
$1.9B, +3% $245M, +5%
Boston Scientific At-A-Glance: 2016
$1.0B, +12%
$1.4B, +10%
$200M+
Peripheral
Interventions
Structural Heart
FY16 reported revenue and operational growth* (total company: $8.4B, +12%)
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Expanding into Multiple High Growth
Adjacencies That Will Approach ~$13B in 2020
BSX 2016
Sales
Market
2020E Growth Accelerators
$200M+ $5B • LOTUS Edge - TAVR
• ACURATE - TAVR
• WATCHMAN global expansion
~$50M $2B • Visualization
• Cancer
• Overactive bladder
~$50M $2B • Pathology
• Infection
• Endo-luminal surgery
~$25M $1B • Vercise – Brain
• Other indications 2020+
~$25M $2B • Eluvia - DES
• Ranger – DCB
• Critical Limb Ischemia (CLI)
IC: TAVR + LAAC
PI Drug Eluting
Endo new markets
Uro/PH new markets
Neuromod - Brain
~$13B ~$0.3B
--- $1B RM Diagnostics • Heart Failure
• ICM
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Rhythm Management = CRM + EP + Diagnostics:
A Growing Market with Continued Innovation
CRM EP ICM Total RM
2016 Market Size $9.3B $4.3B $0.6B $14B+
5 yr CAGR (2016-2021) flat +10-12% +8-10% +3-5%
CRM
ICD/CRT-D Pacemaker
EP
Rhythmia Other Ablation
Solutions HeartLogic
ICM & Other
Diagnostics
Diagnostics
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ENDURALIFE™ Battery Technology MRI Conditional Labeling
HeartLogic™ Heart Failure Diagnostics SmartCRT™ Therapy (including MultiSite Pacing)
CRM Next Gen: RESONATE™ HV Devices
4 Key Feature Sets to Drive Global Share Gains
U.S. Approval late Sept ‘17
First and only company with ENDURALIFE™ & HeartLogic™ technologies
2 1
3 4
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BSX’s Solution: HeartLogic™
• The first and only heart failure diagnostic that has
been validated for detecting early indications of
worsening heart failure
• Multiple sensor inputs without an additional
implant, helping clinicians move from reactive
treatment to proactive care
RESONATE Feature #4) HeartLogic™:
Improving Heart Failure Management
HeartLogic Results2:
• 70% sensitivity in detecting HF events
• 34 Days median time to HF event
• Only 1.47 unexplained alerts per patient
year
Sen
sit
ivit
y (
%)
Unexplained Alert Rate per patient year (HeartLogic)*
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Arrhythmia Management
(Syncope and AF)
• Unique device design
• Algorithms to detect atrial arrhythmia,
pause, bradycardia and Tachycardia
• System differentiation: seamless patient
interface and back-end monitoring
• Multiple commercial synergies with core
CRM global teams
• FDA and CE mark expected H1:2019
Insertable Cardiac Monitor (ICM):
Entering a New ~$750M Adjacency in 2019
Mobile Handset with Patient Interface &
Connectivity Bridge
Insertable Monitor Implant Tools
Diagnostic-only device platform
designed for cardiac monitoring
and extensible to other diseases
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Differentiate with Modular CRM (mCRM™)
EMBLEM™ MRI S-ICD and Related Systems
EMBLEM™ MRI S-ICD
• >29,000 implants
• $750M market opportunity
Growing Clinical evidence:
• U.S. post-approval demonstrates continued
positive outcomes3:
− 66.6% Primary Prevention, Low EF Patients
− 98.7% success in acute conversion of VT/VF arrhythmias
− Complication-free rate of 96.2% at 30 days
• UNTOUCHED: Primary prevention penetration
• PRAETORIAN: TV-ICD/S-ICD Head-to-head
• MADIT S-ICD: Potential indication expansion
mCRM ™ and Related Systems
• Physician will be able to match device therapy to clinical need in a modular approach
• Demonstrated pre-clinical in vivo feasibility
− Multiple upcoming abstracts on mCRM™
• Clinical investments to prove safety and efficacy:
− EMPOWER MPS and MODULAR ATP IDE
− Clinical start expected in 2019
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RHYTHMIA™ Mapping System:
Winning Placements and Share Gains
>50 Peer-Reviewed JOURNAL ARTICLES
>19,000 Worldwide
CASES
Active in >30 countries, with More Slated
to Launch Over the Next Two Years
Setting the Standard in
High Definition Mapping
25x the
DATA POINTS5
0.01mV NOISE THRESHOLD6
5x faster
MAPPING4
Exponentially more data
See detail never seen before
More accurate & complete mapping
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0
100
200
300
400
500
600
2017 2022
# o
f A
F P
roced
ure
s
(Th
ou
san
ds)
Year
AF Procedure Mix
Single Shot
Point RF
RF Balloon Technology Expands Treatment Options
The Apama RF Balloon Catheter System delivers differentiated single shot therapy to
address a $500M opportunity growing to >$1B in 5 years
• Single shot, multi-electrode RF balloon
based technology designed to treat atrial
fibrillation patients
• Built-in cameras allow for real-time
visualization of electrode tissue contact
• Designed to allow customization of energy
delivery around circumference of balloon
• Streamlined procedure via integrated
pacing and sensing electrodes that
eliminate need for separate diagnostic
catheter
• CE mark Q4:18E
• U.S. IDE enrollment early 2019E
Atrial Fibrillation
(AF) 48%
Atrial Flutter 17%
Other SVT 27%
VT 8%
Global Ablation Procedure Mix
11%
CAGR
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RF Balloon Technology Overview
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DirectSense™ Technology: New Tool for
Physicians in RX/Therapeutic Catheters
DirectSense™ Technology will provide physicians with a new tool
that enables more information on the tip-to-tissue interface
• Enhanced confidence in the
location, stability, and proximity of a
catheter relative to tissue
• Enabled via a software upgrade to
RHYTHMIA HDx™ when used with the
IntellaNav™ MiFi OI catheter
• Europe limited market release Q4:17
• Full commercialization Q1:18E
• U.S. launch mid-18E
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Force Sensing Technology:
Expanding Our RX / Therapeutic Portfolio
• Addresses $800M+ global market
opportunity
• Provides physicians the contact
force measurements of catheter-
to-tissue
• Currently in design verification and
validation testing with RHYTHMIA
HDx™ integration
• CE Mark H1:19E
• U.S. approval timeline pending FDA
feedback
Force Sensing technology will further expand capabilities of RHYTHMIA HDx™
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Rhythm Management: Innovative Products Targeting
Large Markets While Improving Profitability
• Driving CRM market share gains with differentiated portfolio:
– RESONATE™ family drives success in high voltage segments
– ENDURALIFE™ offers significant battery longevity advantages over competition
– EMBLEM™ MRI S-ICD continues to be the world’s only subcutaneous ICD system
• Building EP market share gains with unique mapping system, full portfolio of catheters, recent investments in single shot Afib therapies
– RHYTHMIA HDx™ & Force Sensing expected to accelerate share gains
– Apama RF Balloon CE mark Q4:18E; begin U.S. IDE trial enrollment early 2019E
• Entry into ICM / Diagnostics space provides highly leveraged growth
• Strategic investments offer access to new growth channels
• Continued strong leverage expected in Operating Income
– Targeting >400bps adj. operating margin improvement 2017-2020
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Rhythm Management References
1. Assumes: 2.0V RA, LV-only, 2.0V LVa, 2.0V LVb, 700Ω, No LATITUDE, No Respiratory Rate Sensor, No Heart Failure
Sensor Suite
2. Boehmer et al. A Multisensor Algorithm Predicts Heart Failure Events in Patients With Implanted Devices. Results
from the MultiSENSE Study. JACC: Heart Failure. Volume 5 Issue 3. March 1, 2017
3. Heart Rhythm. 2017 May 11. pii: S1547-5271(17)30594-5. doi: 10.1016/j.hrthm.2017.05.016. [Epub ahead of print]
4. Based on approximate mapping speed of 95 pts / minute in the right atrium in 5 swine USING THE ST. JUDE
PRECISION ENSITE MAPPING SYSTEM. Ptaszek LM, et al. “Rapid High-Density Automated Electroanatomical
Mapping Using Multiple Catheter Types.” Poster Session PO097 APHRS 2015.
5. Based on approximate mapping speed of 491 pts / minute in the right atrium in 5 swine USING THE BOSTON
SCIENTIFIC RHYTHMIA MAPPING & NAVIGATION SYSTEM. Ptaszek LM, et al. “Rapid Acquisition of High-Resolution
Electroanatomical Maps Using a Novel Multielectrode Mapping System.” JICE. Nov 2012.
6. C1. Ptaszek L, Chalhoub F, Perna F, Beinart R, Barrett C, Danik S, Heist EK, Ruskin J, Mansour M, Rapid Acquisition
of High-Resolution Electroanatomical Mapping Using a Novel Multi-Electrode Mapping System. J Interv Card
Electrophysiology. 2012 Nov 22.
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Supplemental Non-GAAP Disclosures
Adjusted Free Cash Flow ( in billions) 2018E-2020E 2020E* 2019E* 2018E* 2017E*
Operating Cash Flow, estimated GAAP -$ -$ -$ -$ -$
Plus: Proceeds on disposals of property, plant and equipment - - - - -
Less: Purchases of property, plant and equipment - - - - -
Free Cash Flow - - - - -
Plus: Special Adjustments - - - - -
Adjusted Free Cash Flow 6.6$ 2.4$ 2.2$ 2.0$ 1.750$
Approximate CAGR of 10% year over year: 10% 10% 10%
* - Components of the reconciliation of operating cash flow, as reported are not currently available.
Revenue Growth 2017E (Low) 2017E (High) 2016 2015 2014
Revenue growth, as reported 7% 8% 12% 1% 3%
Less: Impact of foreign currency fluctuations 0% 1% 0% -7% -3%
Operational Revenue Growth 7% 7% 12% 8% 6%
Less: Impact of significant acquisitions 1% 1% 2% 3% 2%
Organic Revenue Growth 6% 6% 10% 5% 4%
Organic Revenue CAGR 2015-2017E 7%
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Supplemental Non-GAAP Disclosures
Earnings Per Diluted Share 2017E (Low) 2017E (High) 2016 2015 2014
GAAP net income (loss) per share 0.71$ 0.75$ 0.25$ (0.18)$ (0.09)$
Non-GAAP adjustments 0.53 0.52 0.86 1.11 a 0.93
Adjusted net income (loss) per share 1.24$ 1.27$ 1.11$ 0.93$ 0.84$
Less: Impact of foreign currency fluctuations in 2016 0.06 -
Adjusted net income (loss) per share, excluding FX 1.17$ 0.93$
Adjusted net income (loss) per share 0.93$ 0.84$
Less: Impact of foreign currency fluctuations in 2015 0.10 -
Adjusted net income (loss) per share, excluding FX 1.03$ 0.84$
Adjusted EPS growth from prior year 20% 11% 15%
Adjusted EPS growth from prior year, excluding FX 26% 23%
a - Assumes dilution of 21.5 million shares for the year ended December 31, 2015 for all or a portion of these non-GAAP adjustments.
b - Assumes dilution of 23.7 million shares for the year ended December 31, 2014 for all or a portion of these non-GAAP adjustments.
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Supplemental Non-GAAP Disclosures
Revenue Growth (%)
Interventional Cardiology 12% -1% 13% 0% 13%
Peripheral Interventions 12% 0% 12% 0% 12%
Cardiovascular 12% 0% 12% 0% 12%
Cardiac Rhythm Management 2% -1% 3% 0% 3%
Electrophysiology 4% -1% 5% 0% 5%
Rhythm Management 3% 0% 3% 0% 3%
Endoscopy 10% 0% 10% 1% 9%
Urology & Pelvic Health 45% 0% 45% 31% 14%
Neuromodulation 11% -1% 12% 0% 12%
MedSurg 20% 0% 20% 9% 11%
*based on previously reported operational growth rates
2016
OrganicAs Reported
Less: FX
Impact Opertional*
Less:
Acquisitions
Adjusted Operating Margin 2020E
Operating margin, as reported 23%
Less: Non GAAP adjustments -5%
Adjusted operating margin 28%
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Supplemental Non-GAAP Disclosures
The following is an explanation of the adjustments that management excluded from GAAP measures to calculate the following
forward-looking non-GAAP financial measures:
Adjusted Gross Margin: Excludes from GAAP gross margin the impacts of forecasted acquisition- and divestiture- and restructuring-
related charges or credits.
Adjusted SG&A: Excludes from GAAP SG&A the impacts of forecasted acquisition- and divestiture- and restructuring-related charges
or credits.
Adjusted R&D: Excludes from GAAP R&D the impacts of forecasted acquisition- and divestiture- and restructuring-related charges or
credits.
Adjusted Operating Margin: Excludes from GAAP operating margin the impacts of forecasted acquisition- and divestiture- and
restructuring- and restructuring-related charges or credits, and amortization expense.
Adjusted Tax Rate: Excludes from GAAP tax rate the tax impacts related to forecasted acquisition- and divestiture- and restructuring-
and restructuring-related charges or credits, and amortization expense.
Adjusted Free Cash Flow: Adjusts GAAP operating cash flow to include the impacts of forecasted capital expenditures and excludes
the impact of estimated after-tax acquisition- and divestiture-, restructuring- and litigation-payments.
Please refer to our Safe Harbor for forward-looking statements disclosure in conjunction with any forward looking information
presented within.