ABIOMED TCT INVESTOR UPDATE: 2017

Transcription

1 ABIOMED TCT INVESTOR UPDATE: 2017 A GROWING POPULATION OF HIGH RISK AND CARDIOGENIC SHOCK PATENTS

2 LEGAL DISCLAIMERS This presentation contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities, the Company s guidance for future financial performance and expected regulatory approvals. Each forward-looking statement contained in this presentation is subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statement, including uncertainties associated with development, testing and related regulatory approvals; the potential for future losses; the impact of complex manufacturing processes and high quality requirements; dependence on limited sources of supply; competition; technological change; government regulation; third-party reimbursement to the Company s customers; litigation matters; future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this presentation. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this presentation or to reflect the occurrence of unanticipated events, whether as a result of new information, future events or otherwise, unless otherwise required by law. U.S. Food and Drug Administration Approvals The Impella 2.5 and Impella CP Systems are temporary ( 6 hours) ventricular support devices indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 or Impella CP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events. The Impella2.5, Impella CP, Impella 5.0, and Impella LD Catheters, in conjunction with the Automated Impella Controller (collectively, "Impella System Therapy"), are temporary ventricular support devices intended for short term use ( 4 days for the Impella 2.5 and Impella CP, and 6 days for the Impella 5.0, and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP). The intent of the Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function. The Impella RP System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area 1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. For safety information associated with Abiomed s technologies, visit and Impella ECP TM, Impella CP + Impella 5.5 TM, Impella BTR TM, The Impella Pediatric TM, and Symphony are in development and are not approved for use or sale. The ABIOMED logo, ABIOMED, Impella CP, Impella RP and Symphony are registered trademarks of Abiomed, Inc. in the U.S.A. and certain foreign countries. Impella 2.5, Impella 5.0, Impella LD, Impella BTR, cvad Registry, Impella ECP and Recovering hearts. Saving lives. is a trademark of Abiomed, Inc.

3 INFORMATION INTENDED SOLELY FOR INVESTORS The content of this presentation includes a discussion of Abiomed products that have not been approved or cleared by the United States Food and Drug Administration and are not available for sale in the United States. This presentation also discusses certain uncleared and unapproved uses of Abiomed products. This information is intended solely for purposes of informing the investment community, and not for any other purposes. This information is intended For Investors Only, and not for customers, potential customers or other Healthcare Professionals.

4 ANDREW GREENFIELD, VICE PRESIDENT ABIOMED 4 Mr. Andrew J. Greenfield is a Vice President and General Manager at Abiomed, Inc. responsible for the Healthcare Solutions and Global Marketing organizations. Mr. Greenfield has served as an Executive Officer of Abiomed since 2005 where he leads a broad spectrum of strategic initiatives including patient advocacy, government affairs, health economics and reimbursement, communications, clinical marketing, service operations and new market development. Mr. Greenfield has spent over 20 years in leadership positions for advanced technology companies including Abiomed, GE Healthcare and Boeing with a particular focus on expanding patient access to leading edge technology designed to treat cardiovascular disease. He is currently on the Board of Directors for MassMEDIC in Boston, MA, a public-private partnership that coordinates the resources used in managing medical devices to improve patient access to cutting-edge medical technology. He is a past executive committee member with the Medical Device Innovation Consortium (MDIC) which is advancing safer and more cost-effective innovations that benefit patients through a collaboration between the Centers for Medicare & Medicaid (CMS), Food and Drug Administration (FDA), industry and patients. Mr. Greenfield received his Bachelor degree in Finance from the University of Illinois and Masters of Business Administration from St. Louis University. He is also a certified Master Blackbelt in Six Sigma and Change Acceleration Process from GE. Originally from Illinois, he now resides in Massachusetts with his family.

5 TODAY S TOPICS 5 The population of patients of high risk PCI and cardiogenic shock continues to grow Impella aligned with healthcare reform and cost effectiveness Expanding awareness and improving outcomes

6 8% PENETRATION TODAY 20% YIELDS >$1.0B IN U.S. 6 U.S. Annual Number of High Risk Patients (TAM): Protected PCI 1 Emergent 2 121,000 (Elective + Urgent) 100, ,000 Total Run-rate Penetration Right-side Failure 3 10,000 Impella RP Patients Japan 4 Germany 5 50,000 in Japan 25,000 in Germany 1) American Heart Association, Heart Disease and Stroke Statistics 2015 Update ; Gheorghiade et al Circulation, ; Braunwald, et al. JACC ; Dehmer, et al. JACC 2012 ; Eric Peterson_nejm_2010 ; JAMA, Cornwell ; Farmer SA, JACC. Cardiovascular imaging. Jul Truven Analysis, in Press 2) HRI 2015: Cardiogenic Shock ; and American Heart Association, 2015 Statistics 3) Right heart failure from AMI RV infarct, respiratory issues, LVAD, failed transplant: HRI 2009 Report, ISHLT, Intermacs. 4) IABP usage with PCI and AMI, 2009 report on Catheter, Tube, & Interventional Device ; About 40% of PCI was for AMI, Coronary Stent survey by PMDA. 5) German Heart Report, 2015

7 A GROWING POPULATION APPROPRIATE FOR PCI 7 1.7M Patients Class III/IV Heart Failure 1 Plus 261,000 Annual Incidence 1 68% Have Coronary Artery Disease (CAD) 2 60% With Reduced Ejection Fraction 3 55% Good vessel targets and not CABG candidates 6 Patient Comorbidities Protected PCI Patients Complex Coronary Artery Disease 28% (121,000)* Diagnosed Ischemic Disease 7,8 72% (319,000) Undiagnosed Not tested for Ischemic Disease 7 Hemodynamic Compromise (depressed left ventricular ejection fraction) Protected PCI Now FDA Indicated Safe & Effective 1. Heart disease and stroke statistics update, Circulation Jan 27;131(4): 2. Gheorghiade M1, Bonow RO. Circulation Jan 27;97(3): Braunwald E, JACC Heart Fail Feb;1(1): O Neill et al Circulation Oct 2;126(14): Patel MR, Peterson ED, et al. N Engl J Med Mar 11;362(10): Cornwell LD, Omer S, Rosengart T, Holman WL, Bakaeen FG. JAMA Surg Apr;150(4): Farmer SA et al. JACC Cardiovasc Imaging Jul;7(7): Kirtane AJ, et al. Submitted for publication, under review

8 COMPLEX POPULATION CONTINUES TO GROW: COMPLEX, CHRONIC, AGING POPULATION FURTHER CONTRIBUTES TO NEED 8 Percent of PCI Cases that had MCC of 4+ Vessels or Stents 1 Infrequent Evaluation for Ischemic Disease 2 Inpatient PCI cases are increasing in complexity and Complex CAD is underdiagnosed Fewer than 1 in 10 patients received noninvasive ischemic testing for CAD during the index admission for Heart Failure Advisory Board, All Rights Reserved. MedPAR claims ; PCI volumes under consideration include MS-DRGs ; Complex PCIs include MS-DRG 246, Doshi, D. et al. J Am Coll Cardiol. 2016;68(5):450-8.

9 MACCE (%) IMPELLA REDUCES PERI & POST PROCEDURAL MACCE MACCE MACCE = Death, Stroke, MI, Repeat revasc. IABP N=211 29% reduction In MACCE 15 Impella N= p= Time Post Procedure (day) FDA Approved Randomized Controlled Trial Protect II Dangas et al, Am. Journ of Cardiol. 2014: 113(2):222-8

10 IMPROVEMENT IN QUALITY OF LIFE POST PCI 10 NYHA Class Improvement Post Procedure p< % 58% Reduction in Class III,IV 8% 18% Class IV 45% 30% Class III Class II 31% 44% Class I 7% Baseline 90 days N=223 patients from Both Arms of Protected II Trial with NYHA measurements available at baseline and 90 days 1 FDA Approved Randomized Controlled Trial Protect II O Neill WW et al. Circulation Oct 2:126(14):

11 COST EFFECTIVENESS OF PROTECTED PCI 11 Reduced Length of Stay Total Days in Hospital 1,3 Less Readmissions from Repeat Procedures 9.0 p= days or 22% 12.4% p= % Reduction % N=211 N=216 N=211 N=216 IABP Impella IABP Impella Median days in hospital; index stay through 90 days, N=427, Readmissions N= Gregory, O Neill, et al. American Health & Drug Benefits 2013 Mar;6(2): Gregory, et al. Managed Care Medicine, Feb Maini, et al. Expert Rev Pharmacoecon Outcomes Res Jun;14(3):403-16

12 HIGH RISK PCI ALGORITHMS FACILITATE COORDINATION 12 Updated 2015 & 2016 High Risk PCI Consensus ACC/SCAI/HFSA/STS Expert Consensus, ACC Interventional Scientific Council University Hospitals Cleveland Medical Center Protected PCI Algorithm Einstein Healthcare Network Protected PCI Algorithm

13 Death Rate, % AMI SHOCK MORTALITY UNCHANGED IN > 20 YEARS 13 US AMI/CGS cases per year 1,2 High In-Hospital Mortality During AMI Cardiogenic Shock N = 23, Sandhu A, McCoy l, Negi S, et al. Use of Mechanical Circulatory Support in Patients Undergoing Percutaneous Coronary Intervention; Insights from the National Cardiovascular Data Registry. Circulation, 2015;132: Acute Cardiac Assist Report, Health Research International August Jeger, et al. Ann Intern Med. 2008

14 Survival Rate SHORT-TERM MCS LINKED TO REDUCED MORTALITY & REDUCED COSTS Day Survival 1.0 cvad Registry * N= Impella Pre-PCI 2007 to 2011 use of pvads increased 1,511% with a mortality decrease from 41% to 33%. Hospital costs also declined. IABP use and in-hospital death were associated with cost increases of 25.2%. Predictors of death included a diagnosis of cardiogenic shock and use of IABP or cardiopulmonary resuscitation before short-term MCS IABP and/or Inotropes Pre-PCI Log-Rank, P= Days from Initiation of Impella Stretch et al. JACC 2014 O Neill, et al., J. Int. Cardiol, 2014

15 SHOCK PROTOCOLS STANDARDIZE CARE AND ARE ASSOCIATED WITH IMPROVED OUTCOMES 15

16 OBSERVED CARDIOGENIC SHOCK IMPROVEMENT Sites supporting >6 AMICS patients. Data on file. Abiomed Impella Quality(IQ) Database observational data used for trend identification, AMI/CGS March 2015 Sept Danvers, MA: Abiomed

17 Hospital Days SYSTEMATIC REVIEW OF IMPELLA COST EFFECTIVENESS 17 Reduction of Length of Stay for PVADs Elective and Urgent Setting Emergent Setting days - 2 days - 2 days days - 4 days - 5 days - 10 days -11 days P=0.008 P=.001 P=.04 P=.338 P=.055 P=N/A* P=.05 P=.003 Maini, et al. Pharmacoecon. Outcomes Res Gregory et al. [28] 2. Gregory et al. [27] 3. Aryana et al. [44] 4. Wohns et al. [46] 5. Maini et al. [29] 6. Cheung et al. [31] 7. Gregory et al. [27] 8. Maini et al. [29]

18 Incremental Cost IMPELLA IS A COST-EFFECTIVE THERAPY 18 Costs QALY Costs QALY 0 Protect II ICER $39,389/QALY Costs QALY Protect II Cost Effectiveness Study, TCT 2011 Uspella, Mach II, Pinnacle Health AMI modeling estimate Quality of Life Years (QALY) or Life Years Gained (LYG), based on available data Emergent ICER -$134,932/LYG DOMINANT Quality Adjusted Life Years/LYG Costs QALY

19 Incremental cost per life year or QALY ($thousands) IMPELLA IS COST-EFFECTIVE 19 $274k $175 $199k $150 $125 $100 <$100,000 Threshold (US) $75 $50 $25 HCS-PP rf $ CRT-P C-reactive Clopidogrel CRT-D Impella TAVR AF Impella Dialysis LVAD 1 Protein US Registry (LYG) ablation EU Registry (LYG) DT(LYG) Aspirin MI 1 Impella Emergent $135k cost savings 1. Maini, et al. CCI, Earnshaw, et al. Arch. of Intern Med., Feldman, et al. JACC, COMPANION 4. Choudhry, et al. JACC, JUPITER 5. Chen, et al. ISPOR, 2009.CHARISMA Impella PROTECT II 6. Gregory, et al. Am Health & Drug Ben, Feldman, et al. JACC, COMPANION 8. Roos, et al. J Med Econ, Reynolds, et al. ACC, LVAD 2 DT(LYG) 10. Reynolds, et al. Circ Arrhythm Electrophysiol, Winkelmayer, et al. Medical Decision Making, Slaughter, et al. AHA, Russo, et al. ACC 2010.

20 INVESTING IN EDUCATION & BUILDING A NEW FIELD OF HEART RECOVERY 20 TCTMD Panel Discussion Clinical Dossier Impella.com Mobile Learning Lab Education Program Key Partners

21 PHYSICIAN AWARENESS & EDUCATION 21 Resource Library

22 DTC: NEW CGS COMMERCIAL & PATIENT OUTREACH MATERIALS 22

23 CONCLUSIONS 23 The population of patients for high risk PCI and cardiogenic shock continues to grow Impella aligned with healthcare reform and cost effectiveness Expanding awareness and improving outcomes through physician education, hospital program development and best practices

24 ABIOMED: A LONG RUNWAY FOR PROFITABLE GROWTH Existing Opportunity: The Field of Heart Recovery Protected PCI Program: 7% Penetration of 121k Potential U.S. Patients AMI Cardiogenic Shock: 8% Penetration of 100k Potential U.S. Patients Impella RP: PMA Approved ; Commercially Launching ; Potential 10k U.S. patients Germany: 11% Penetration of 25k Potential Patients 2. Mid / Long Term Opportunity: Japan: Commercially Launching ; 2 nd largest med tech market ; Potential 50k patients New products (fiber optic sensor, remote monitoring, Impella ECP, Impella 5.5, Impella BTR) STEMI: Currently Enrolling Feasibility Study ; Goal to revolutionize AMI care (heart attack) ; 200k Potential U.S. Patients New geographies (ROW)

25 25 THANK YOU

26 26 APPENDIX

27 PROTECTED PCI EJECTION FRACTION (EF) DATA 27 Data Source # Patients Median EF Mean EF Impella Quality (IQ) Database 20,035 21% 25% CVAD Registry % 29% Protect II RCT % 23% IMPELLA QUALITY (IQ) DATABASE, HRPCI April 2009 Jun 2017

28 EF AT HIGHEST VOLUME SITES VS LOW/MODERATE VOLUME SITES 28 Ejection Fraction of Protected PCI Patients Mean Median 25% 24% 23% 20% N = 18,156 N = 1,878 N = 18,156 N = 1,878 Low to Moderate Volume Sites (Aggregate) Top 10 Highest Volume Sites (Aggregate) IMPELLA QUALITY (IQ) DATABASE, HRPCI April 2009 Jun 2017

29 SHORT-TERM MCS LINKED TO REDUCED MORTALITY, REDUCED COSTS Conclusion: Use of short-term MCS in the United States has increased rapidly, whereas rates of inhospital mortality have decreased. These changes have taken place in the context of declining hospital costs associated with short-term MCS % and 58% Mortality Reduction in AMI and CAD Cost Reduction $45k and $54k per case in AMI and CAD Stretch et al. JACC 2014;64: