Transcatheter Cardiovascular Therapeutics 2018

Transcription

1 Transcatheter Cardiovascular Therapeutics 2018 Jeff Mirviss, SVP & President, Peripheral Interventions Kevin Ballinger, EVP & President, Interventional Cardiology Dr. Ian Meredith, EVP & Global Chief Medical Officer

2 Safe Harbor for Forward-Looking Statements This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 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. Non-GAAP Measures: This document contains non-gaap measures (denoted with *) in talking about our company s performance. For reconciliations of non- GAAP financial measures to the most directly comparable GAAP figures, please refer to the addendum to this presentation and the Investor Relations section of our website at Market Estimates: Unless noted otherwise, all references to market sizes, market share positions, and market growth rates are BSX internal estimates. 2

3 Peripheral Interventions Jeff Mirviss, SVP & President, Peripheral Interventions Catherine Jennings, Vice President, Marketing 3

4 Boston Scientific Corporation. All rights reserved.

5 ELUVIA FDA Approval The ELUVIA DES Received FDA Approval Earlier Than Expected Early Approval Speaks to Quality of Submission Excellent data and clinical program Collaboration with investigators Early/frequent engagement with FDA Results published in The Lancet Accelerating Manufacturing to Meet Demand Full launch ASAP expect October timing Sales team will be fully trained on product/data Boston Scientific Corporation. All rights reserved.

6 IMPERIAL Effectiveness Superior Results in the First Head-to-Head DES SFA Trial ELUVIA DES demonstrated a statistically significant difference in primary patency 2 compared to Zilver PTX 1 at 12 months in the IMPERIAL Trial K-M Survival Analysis 1 Superiority determined in Post Hoc Superiority Analysis (Continuity Adjusted Chi-Square p-value). Primary Effectiveness Endpoint: Primary patency rate of 86.8% in the Eluvia arm vs. 77.5% in the Zilver PTX arm (p-value = ). Primary Safety Endpoint: Major adverse event rate of 4.9% in the Eluvia arm vs. 9.0% in the Zilver PTX arm (p-value = ). 6 2 Primary patency defined as percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without clinically-driven TLR or bypass of the target lesion before or on the DUS FU visit (PSVR 2.5) Boston Scientific Corporation. All rights reserved.

7 IMPERIAL Safety Results 95.1% of ELUVIA DES Patients Were Free of Major Adverse Events at 12 months ELUVIA DES demonstrated half the target lesion revascularization rate of Zilver PTX at 12 months 1. Major Adverse Events (MAEs) defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization through 12 months Boston Scientific Corporation. All rights reserved.

8 ELUVIA Economic Value Economics & Outcomes for Eluvia DES Create Compelling Value Proposition DES DCB DES + ATH DCB + ATH Hospital Reimbursement 1 $10,510 $5,085 $16,019 $10,510 1 Based on 2018 Medicare national average Hospital Outpatient Prospective Payment System Boston Scientific Corporation. All rights reserved.

9 ELUVIA Data Expand Market for DES Data Demonstrate ELUVIA DES Is Treatment Option for Many Patients 2020E SFA Market ~$2.7B $1B addressable market for ELUVIA DES 2020E Imperial Data Expand DES Consideration ELUVIA DES an option for many patient types Clear superiority over existing DES options Large $1B addressable market Category Leadership Offers Contracting Advantage Only company with DES, DCB & atherectomy Technology solution for virtually every case ELUVIA DES expected to lead in $150M+ 2020E SFA DES market May take procedural share from DCB, BMS and POBA Sustainable Competitive Advantage Portfolio drives share & pull-through Expect pricing commensurate with value Boston Scientific Corporation. All rights reserved.

10 ELUVIA Clinical Program ELUVIA DES Supported by Unprecedented Clinical and Economic Data 2,000 Patients expected to be enrolled across 100 centers in the ELUVIA DES clinical program Boston Scientific Corporation. All rights reserved.

11 PI Growth Driven by Breadth Expanding Category Leadership in PI Interventional Oncology Spherical embolics Emerging markets Indication expansion Venous Disease AngioJet System Venous stenting Adjunctive technologies Peripheral Artery Disease Ranger DCB SFA ELUVIA DES SFA Clinical leadership Critical Limb Ischemia SAVAL DES BTK Atherectomy Differentiated Solutions Across Disease States 11

12 Interventional Cardiology Kevin Ballinger, EVP & President, Interventional Cardiology 12

13 Coronary Therapies: Market Leadership with Broad Portfolio OPTICROSS HD JUDO 1, 3 & 6 ROTAPRO SYNERGY Unmatched Breadth Across Coronary Therapies WOLVERINE Complex PCI Consistent Upper Single Digit Growth Stent Portfolio Global DES Leadership PCI Guidance Global Imaging Leader Significant diversification of the IC Business: DES anticipated to be <40% of the IC Revenue Mix in

14 WATCHMAN : LAAC Global Market Leadership PATIENTS and Counting Broad Range of Commercial Activities 60K patients treated worldwide with WATCHMAN TM LAAC Device TV campaign expanded in 8 new U.S. markets U.S. & European approval of TruSeal Access System CMS increase to DRG 273/274-2 nd consecutive increase o ~9% increase in commonly used DRG - October 1, WATCHMAN FLX TruSeal Access System Strong Execution of Clinical Milestones Initiated WATCHMAN PINNACLE FLX clinical trial o Q4:18E enrollment completion o WATCHMAN NOAC Trial OPTION Trial start in 2019E Continued International Expansion China: Increased adoption 5M strokes per year Japan: Approval H1:19E, reimbursement H2:19E Europe: WATCHMAN FLX commercial approval H1:19E

15 TAVR: Driving Execution of Dual-Valve Strategy Global expansion of ACURATE neo valve ACURATE neo Aortic Valve System Fastest growing TAVR valve in Europe >40% growth in 2018 YTD Opened ~130 new accounts since acquisition ~20% share in launched accounts File U.S. IDE with ACURATE neo2 valve in Q4:18E High and intermediate risk trial 500 patients randomized to any approved device Expect ACURATE neo2 CE Mark in H1:19E Enhanced PVL sealing technology 15

16 TAVR: Driving Execution of Dual-Valve Strategy Global launch of LOTUS Edge valve Final technical module of PMA filed with FDA August 15, 2018 LOTUS Edge Aortic Valve System Currently enrolling in the REPRISE III Nested Registry File REPRISE IV Intermediate Risk IDE Q4:18E Includes 810 patients in a single arm study, with a bicuspid sub-study Lotus Edge EU launch Q1:19E U.S. launch mid-19e 16

17 Compelling Breadth of Structural Heart Valves Portfolio Broad SHV Portfolio LOTUS Edge ACURATE neo Execute the dual-valve portfolio globally Continue ACURATE neo TM valve global expansion Launch Lotus Edge into major global markets Sentinel Cerebral Protection System acquisition NTAP ($1,400) effective October 1, 2018 Increasing clinical evidence to support broad use SAFARI 2 isleeve Sentinel Market-leading accessory portfolio SAFARI 2 market leading TAVI wire Expanding patient access with isleeve Expandable Sleeve Millipede Iris Millipede progressing on clinical milestones Anticipate Q1:19 deal close 17

18 Sept 2018: Raising Long Term Growth Outlook 2017A CAGR Goals 2018E Goals 2019 & 2020E Operational Revenue* Growth +8% +9% % +7-10% Contribution from Recent M&A +120 bps inorganic (EndoChoice, Symetis) +40bps inorganic (Symetis) ~+150bps (organic/inorganic split TBD based on deal size & timing of anniversaries) Organic Revenue* Growth +7% +7% +6-7% > % (organic/inorganic split TBD based on deal size & timing of anniversaries) Adjusted Op. Margin* 25.0% ~+175 bps Y/Y annually bps Y/Y bps Y/Y Adjusted Tax Rate* 11.2% 13-14% <15% Adjusted EPS* Growth +13% (+20% ex FX) +15% +9-12% Double-digit goal 18

19 Q&A

20 Appendix A Disclaimers & Non-GAAP Reconciliations

21 Regulatory & Financial Disclaimers Product Regulatory Disclaimer Ranger TM Drug-Coated Balloon SAVAL Drug Eluting Stent Below-the-knee indication Lotus Edge TM ACURATE TM Self Expanding Valve Platform ACURATE neo2 TM Valve System Mitral Valve technologies WATCHMAN TM FLX Revenue Growth Rates: Operational revenue growth is a non-gaap measure that excludes the impact of changes in foreign currency exchange rates. Organic revenue growth is a non-gaap measure that excludes the impact of changes in foreign currency exchange rates and significant acquisitions. Adjusted Operating Margin, Adjusted Tax Rate and Earnings Per Share (EPS) Measures: Adjusted operating margin, effective tax rate, adjusted earnings per share and adjusted earnings per share excluding changes in foreign currency exchange rates are non-gaap measures that exclude the impact of amortization expense, intangible asset impairment charges, acquisition- and divestiture-related net charges and credits, restructuring and restructuring-related net charges and credits, litigation-related net charges, pension termination charges, debt extinguishment charges, certain investment impairments, certain discrete tax items and/or foreign currency exchange rates. 21 CE Marked. US: Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale. CE Marked. US: Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale Pending CE Mark. US: Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. CE Marked. US: Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale. Pending CE Mark. Not available for use or sale in the U.S. Devices under development. Not available for use or sale worldwide. Pending CE Mark. US: Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale

22 Non-GAAP Reconciliations Percentage Change in Net Sales year avg Percentage change in net sales, reported 8% 12% 1% 7% Less: Impact of foreign currency fluctations 0% 0% -7% -2% Percentage change in net sales, operational 8% 12% 8% 9% Less: Impact of significant acquisitions 1% 2% 3% 2% Percentage change in net sales, organic 7% 10% 5% 7% Operating Margin * 2014 Operating margin, reported 14.2% 5.3% -3.8% -4.1% Less: Non-GAAP adjustments -10.8% -18.8% -26.1% -24.3% Operating margin, adjusted 25.0% 24.1% 22.3% 20.2% Average change in basis points year-over-year 160 *Certain prior year balances have been reclassified from Operating Expenses to Other, net to reflect our adoption of ASC Update Please refer to our 2017 annual report for details. Tax Rate 2017 Tax Rate, Reported 88.8% Less: Non-GAAP adjustments 77.6% Effective Tax Rate 11.2% Earnings per Diluted Share GAAP net income (loss) per share $ 0.08 $ 0.25 $ (0.18) $ (0.09) Non-GAAP adjustments a 0.93 b Adjusted net income (loss) per share $ 1.26 $ 1.11 $ 0.93 $ 0.84 Less: Impact of foreign currency fluctations in 2017 (0.08) - Adjusted net income (loss) per share, excluding foreign currency $ 1.34 $ 1.11 Adjusted EPS growth from prior year 13% 20% 11% Adjusted EPS growth from prior year, excluding foreign currency 20% 3-year average adjusted EPS growth 15% a, b - Assumes dilution of 21.5 million shares for 2015 and 23.7 million shares for 2014 for the non-gaap adjustments. 22