Recovering Hearts. Saving Lives.

Transcription

1 Recovering Hearts. Saving Lives ṬM Michael Minogue Chairman, President, & CEO January 8, 2018

2 LEGAL DISCLAIMERS 2 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 is indicated for providing circulatory assistance for up to 14 days 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 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 2.5, Impella CP, Impella RP, Impella 5.0, Impella LD and Symphony are registered trademarks of Abiomed, Inc. in the U.S.A. and certain foreign countries. Impella ECP, Impella 5.5, Impella BTR, cvad Registry and Recovering hearts. Saving lives. is a trademark of Abiomed, Inc.

3 MINIMALLY-INVASIVE FDA-APPROVED ADOPTION 3 STERNOTOMY (Open-Chest Surgery) PLUMBING ELECTRICITY VALVE PUMP Plumbing = CABG Electricity= Surgical ICD/Ablation Valve= Surgical Valve ICU management Stents/PCI 1 Pacemaker / ICDs Edwards & Medtronic TAVR Impella > 1 Million > 400,000 ~60,000 ~18,000 CY 2017 Units/Patients per year in U.S Percutaneous Coronary Intervention. 2. ACC/AHA Heart Disease and Stroke Statistics ; U.S. census data, 2010 ; Company websites and sell-side analyst models

4 THE ABIOMED MISSION 4 To provide percutaneous heart pump technologies for high risk patients to enable better, minimally invasive procedures and to recover heart muscle and save lives

5 ABIOMED: THE HEART RECOVERY COMPANY 5 1. Impella is a patented breakthrough percutaneous heart pump platform 2. Changing the standard of care for multiple indications in growing populations of high risk patients 3. Abiomed is creating the new Field of Heart Recovery and is positioned to capitalize on a $5B U.S. market opportunity

6 IMPELLA HEART PUMPS: BREAKTHROUGH TECHNOLOGY 6 FDA Approvals: High Risk PCI (2015); Cardiogenic Shock (2016); Impella RP for Right Heart Failure (2017) CMS Designated DRG Codes: Reimbursement for implant, explant, transfer & biventricular Impella ~1,200 U.S. hospitals; >65,000 patients 7 Clinical Guidelines; >400 publications CE Mark (2002); Japanese PMDA (2016) 291 patents & 258 patents pending

7 HEMODYNAMIC SUPPORT OF IMPELLA HEART PUMPS 7 Enables High Risk Cath Lab Procedures Maintains Arterial Pressure * Unloads & Protects/Rests the Heart Muscle Impella 2.5 On MAP 110 mmhg -8% -10% -12% MAP 86 mmhg 97 mmhg -15% -23% -51% No Impella + 42 mmhg Case Start Balloon Inflation 15 sec 30 sec 45 sec * Physiologic computational modeling of patient, Am J Physiol 1991;260 : H146-H157

8 THE PERCUTANEOUS IMPELLA HEART PUMP PLATFORM 8 Femoral Insertion Impella 2.5 AIC (Automated Impella Controller) TM Impella Product Penetration in U.S. Heart Hospitals: 1,400 Impella CP 1,171 1,093 Axillary Insertion iphone App Impella 5.0 / LD Impella RP CP RP Total Potential Sites Venous Insertion for Right-Heart

9 FY 2018 Preliminary Guidance: STRONG REVENUE GROWTH & GROSS MARGIN (~84%) FDA Approval AMI / CGS ~31% $ % Abiomed Total Revenue ($M) FDA Approval Protected PCI 43% $445 25% $330 48% 38 Impella Acquisition 14% 44 16% 51 16% 59 FDA 510k Clearance 24% 73 17% 86 18% st Profitable Year 25% % % FY 05* FY 06 FY 07 FY 08 FY 09 FY 10 FY 11 FY 12 FY 13 FY 14 FY 15 FY 16 FY 17 FY 18E Founded 1981, Headquartered in Massachusetts, * New Management, Fiscal year 2005, Calendar year 2004

10 STRONG BALANCE SHEET: PROFITABLE, NO DEBT, CASH 10 GAAP Operating Income ($M) $66 $90 Cash ($M) 2 $277 $319 FY 10 FY 11 $1.5 $17 $8 $29 $213 ($25) ($11) FY 12 FY 13 FY 14 FY 15 FY 16 FY 17 $77 $88 $118 $146 Debt: $0 Deferred Tax Asset 1 : $107 Million FY 12 FY 13 FY 14 FY 15 FY 16 FY 17 Q2 FY Represents the company s deferred tax asset as of September 30, Cash, cash equivalents, short and long term marketable securities

11 ABIOMED ANNOUNCES PRELIMINARY FY 18 Q3 REVENUE 11 Abiomed Announces Preliminary Q3 FY 2018 Revenue of $154.0 Million, Up 34% Over the Prior Year: Preliminary unaudited U.S. revenue from Impella products grew 30% to approximately $130.7 million from $100.3 million in the prior fiscal year For the third quarter of fiscal 2018, U.S. patient usage grew 33% in comparison with same period of fiscal 2017 Preliminary fiscal 2018 guidance upgraded to approximately $582M, from $565M to $575M. Formal guidance and other operational details will be provided on Q3 FY 2018 company earnings call

12 ABIOMED: THE HEART RECOVERY COMPANY Impella is a patented breakthrough percutaneous heart pump platform 2. Changing the standard of care for multiple indications in growing populations of high risk patients 3. Abiomed is creating the new Field of Heart Recovery and is positioned to capitalize on a $5B U.S. market opportunity

13 IMPELLA HEART PUMPS PUMP BLOOD AND ENABLE PCI AND HEART MUSCLE RECOVERY 13 IABP Impella LVAD / BTT** 1976: 510k clearance* Historic Use: ~130k/yr in U.S. 2008: 510k clearance 2015/2016: FDA Approved Designed for Transplant Requires Sternotomy * IABP grandfathered in, on market before creation of 510k clearance ** BTT = Bridge to Transplant

14 14 CORONARY ARTERY DISEASE (CAD) & HEART FAILURE IN U.S.: PROTECTED PCI AND HEART RECOVERY PATIENTS* #1 Cause of Death: CAD / HF >15M people with CAD 875,000 deaths per year from CAD #1 Risk: Ejection Fraction & First Heart Attack Low EF increases mortality and decreases QOL 1 First heart attack reduces ~15 years of patient s life and 47% of women / 36% of men will die within 5 years #1 Cardiac Mortality Risk: Cardiogenic Shock ~50% mortality rate for last 20 years 2 Elective Urgent #1 U.S. Health Expenditures: Heart Care $555B in 2016 to $1.1T by % of U.S. population by 2035 will have heart disease 3 Emergent * American Heart Association: Heart Disease and Stroke Statistics 2015 Update 1. Halkin A et al. Prediction of mortality after primary percutaneous coronary intervention for acute myocardial infarction, J Am Coll Cardiol 2005;45: ; Solomon et al. Influence of Ejection Fraction on Cardiovascular Outcomes in a Broad Spectrum of Heart Failure Patients, Circulation 2005; Curtis JP, Sokol SI, Wang Y, Rathore SS, Ko DT, Jadbabaie F, et al. The association of left ventricular ejection fraction, mortality, and cause of death in stable outpatients with heart failure. J Am Coll Cardiol 2003; 42: Historic Survival without Impella Support/Protocols: : ~50% Mortality ; 2017 CULPRIT SHOCK Study: ~50% Mortality, NEJM ; Jeger, et al. Ann Intern Med Heart Disease Could Cost U.S. $1 Trillion Per Year By 2035: Report.

15 $5 BILLION U.S. MARKET FOR FDA & CMS APPROVED PRODUCTS AND INDICATIONS WITH ~9% PENETRATION TODAY 15 U.S. Protected PCI 1 Annual Number of High Risk Patients (TAM): 121,000 (Elective + Urgent) Run-rate Penetration Emergent 2 Right-side Failure 3 10,000 (Impella RP Patients) 100,000 (Cardiogenic Shock) 231,000 Patients Impella 5.5 TM* / BTR TM* 100,000 (Future Products) STEMI 1 200,000 (New Indication - FDA feasibility Study WIP) 1) American Heart Association, Heart Disease & Stroke Statistics, 2015 Update; Gheorghiade et al. Circulation; Braunwald, et al. JACC; Dehmer, et al. JACC; 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. * Impella 5.5 TM and Impella BTR TM are in development and are not approved for use or sale.

16 PROTECTING & RECOVERING HEART MUSCLE 16 Protected PCI / Elective & Urgent Cardiogenic Shock / Emergent Other Right-Side Support VT Ablation (EP Lab) * * The FDA has not deemed the use of Impella devices during VT ablation procedures to be safe and effective

17 FDA APPROVED INDICATIONS: SAFE & EFFECTIVE 17 High Risk PCI Indication (Elective + Urgent): Approved by FDA March 23, 2015 * Cardiogenic Shock Indication (Emergent): Approved by FDA April 7, 2016 Impella 2.5 System during a high risk PCI procedure may allow a longer and more thorough procedure by preventing episodes of hemodynamic instability Fewer later adverse events (e.g. Need for repeat HRPCI procedures) compared to IABP. The Impella heart pumps stabilize the patient's hemodynamics, unload the left ventricle, perfuse the end organs and allow for recovery of the native heart. * High-Risk Percutaneous Coronary Intervention (PCI) FDA Approvals: March 23, 2015 for Impella 2.5 ; December 7, 2016 for Impella CP.

18 MACCE (%) IMPELLA REDUCES ADVERSE EVENTS IN PROTECTED PCI MACCE = Death, Stroke, MI, Repeat revasc IABP N=211 29% reduction in MACCE 15 Impella 2.5 TM N= p= Time Post Procedure (days) FDA Randomized Controlled Trial: Protect II (Impella 2.5 ) MACCE, Major Adverse Cardiac and Cerebrovascular Event, defined as death, stroke, MI, repeat revascularization Dangas et al, Am. Journ of Cardiol. 2014: 113(2):222-8

19 IMPROVEMENT IN QUALITY OF LIFE POST PROTECTED PCI 19 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% FDA Approved Randomized Controlled Trial Protect II, N=223 Baseline 90 days O Neill WW et al. Circulation Oct 2:126(14):

20 Survival Rate IMPELLA LINKED TO REDUCED MORTALITY & REDUCED COSTS IN AMI CARDIOGENIC SHOCK Day Survival 1.0 Publication: Abiomed cvad Registry *, N=154 With the use of pvads mortality decreased from 41% to 33% while hospital costs 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 Impella Pre-PCI IABP/Inotropes Pre- PCI Log-Rank, P= Days from Initiation of Impella Stretch et al. JACC 2014 O Neill, et al., J. Int. Cardiol, 2014

21 IMPELLA HEART PUMPS ALIGN TO HEALTHCARE REFORM 21 Improves Quality of Life: Reduction of Class III and IV Heart Failure: 58% 1, 52% 2 Improves Quality of Life: Heart ejection fraction increase of 32% 3, 31% 4, 22% 1, 17% 2, 13% 5 Impella support protects the kidneys during high-risk PCI, resulting in a 6x reduction in acute kidney injury and need for dialysis 6 Reduces Mortality: Early initiation of Impella in acute myocardial infarction complicated by cardiogenic shock improves survival 7, 8, 9, 10, 11, 12, 13 Early initiation of Impella in AMI CS decreased in-hospital or 30-day mortality by 48% compared with late initiation of Impella 7 Hemodynamic support demonstrates significantly reduced mortality with PVADs when compared to IABP in patients undergoing PCI 14 Is Cost-Effective: Declining hospital costs (Cost Reduction $45k and $54k per case in AMI and CAD) 8 Reduces hospital length of stay 9,15,17,18,19, 20, 21, 22, 23 Reduces expensive hospital readmission costs 17 Creates minimal impact on payer s budget 18 Reduces acute kidney injury, lowers costs on average $22,023 per case O Neill et al, Circulation. PROTECT II, Maini et al, Journal of American College of Cardiology (abstract). USPella, Burzotta et al J Card Med, Dixon et al. Journal of American College of Cardiology Interv. PROTECT I, Sjauw et al. Journal of American College of Cardiology. MACH 2, Flaherty MP, et al. Circ Res Jan Flaherty et al, Meta-Analysis, Cardiovascular Interventions, Stretch et al, Journal of the American College of Cardiology, O Neill et al, Journal of American College of Cardiology. USPella, Basir et al, American Journal of Cardiology, Meraj et al, Journal of Interventional Cardiology, Joseph et al, Journal of Interventional Cardiology, Schroeter et al, Journal of Invasive Cardiology, Patel et al. Journal of Interventional Cardiology, Maini et al,journal of Catheterization and Cardiovascular Interventions, Maini et al, Expert Review Pharmaeconomics & Outcomes Research, Roos et al, Journal of Medical Economics, Gregory et al, American Health & Drug Benefits Journal, Gregory et al, Journal of Managed Care Medicine, Krenn et al, SCAI, Aryana et al, Heart Rhythm Society, Wohns et al. International Society for Minimally Invasive Cardiothoracic Surgery, Lamarche et al. Journal of Thoracic and Cardiovascular Surgery, Silver, et al. Journal of Hospital Medicine 2016

22 ABIOMED: THE HEART RECOVERY COMPANY Impella is a patented breakthrough percutaneous heart pump platform 2. Changing the standard of care for multiple indications in growing populations of high risk patients 3. Abiomed is building the new Field of Heart Recovery and is positioned to capitalize on a $5B U.S. market opportunity

23 INVESTING IN EDUCATION & FIELD OF HEART RECOVERY 23 Physician Education Education Programs and Dossiers ProtectedPCI.com / Impella.com Mobile Learning Lab DTC: TV Commercials Key Influencers

24 RAMPING MANUFACTURING & PRIORITIZING GLOBAL MARKETS 24 Japanese HQ: Tokyo Approved ,000 Potential Patients / Yr Abiomed Global HQ: Massachusetts Founded 1981,~1,000 Global Emp. 170,000 sq. ft. with Manufacturing Capacity European HQ: Aachen, Germany 71,000 sq. ft. with Manufacturing Capacity Germany: 25,000 Potential Patients / Yr Impella Products Approved ; Key Market ; Direct Distribution/Coverage ; Reimbursement Impella Products Approved ; No / Limited Distribution Coverage

25 IMPELLA PLATFORM: A LONG RUNWAY FOR GROWTH 25 Products Impella 2.5 Impella CP Impella 5.0 Impella RP HDE Impella ECP TM Impella 5.5 TM Impella BTR TM Wearable Driver Indications Protected PCI Cardiogenic Shock Right-Side & Left Side Support Additional Indications (~2018) STEMI (Infarct Reduction) Heart Failure (Class III) 200K U.S. Patients 100K U.S. Patients Geographies U.S. Germany Japan Rest of World 231K Patients 25K Patients 50K Patients Today / 2018 Future* * Impella ECP TM, Impella 5.5 TM, Impella BTR TM, are in development and are not approved for use or sale. Future additional indications and STEMI are not approved for use.

26 AMBULATION WITH AXILLARY APPROACH AND FUTURE IMPELLA PRODUCTS WITH HIGHER FLOW AND LONGER DURATION 26 Current Future Impella 5.0 Impella 5.5 TM Designed for months of use and flow 5.5 L/M First in Man: 1H CY 2018 Impella BTR TM Designed for up to 1 year of use and flow 5.5 L/M With Wearable Driver for Hospital Discharge * The Impella 5.0 is intended for short term use of 6 days. DISCUSSION OF DEVICES IN DEVELOPMENT

27 FUTURE IMPELLA HEART PUMPS WITH HIGHER FLOW AND LONGER DURATION FOR HEART FAILURE 27 Implantable BTT LVAD / Sternotomy * Impella future heart pump cadaver implant DISCUSSION OF DEVICES IN DEVELOPMENT

28 STEMI DTU FDA FEASIBILITY STUDY THESIS: UNLOADING REDUCES REPERFUSION INJURY & INFARCT SIZE 28 Infarct Unloading Animal Study Impella OFF Perfusion Imaging of Human Heart Impella OFF Impella ON Impella ON Within 5 years, 76% have Heart Failure ** Flameng et al 2000: JACC 2001 Aqel et. al. J Nuclear Cardiology, 2009 See Appendix for STEMI Study Details (50 patients / 10 sites) DISCUSSION OF POTENTIAL FUTURE FDA APPROVAL FOR USE

29 ABIOMED: THE HEART RECOVERY COMPANY IMPELLA : REVOLUTIONIZING THE STANDARD OF CARE 29 Protected PCI Emergency Heart Attack (STEMI) Heart Failure Impella RP Impella CP Future Indication: Reduce Size of Infarct (Dead Heart Muscle) Future Products: Impella 5.5 / BTR DISCUSSION OF POTENTIAL FUTURE FDA APPROVAL FOR USE

30 APPENDIX

31 ABIOMED PRINCIPLES PATIENTS FIRST 31 RECOVERING HEARTS & SAVING LIVES Recovering hearts and saving lives is the founding principle and guiding compass of our organization. This is our highest recognition of success. Recovering and preserving our patients hearts enables them to return home to their families and enjoy an improved quality of life. GROWING SHAREHOLDER VALUE Growing shareholder value rewards our investors and helps to ensure the company s financial stability, allowing for the continued pursuit of our mission. Shareholder value is driven by executing our goals and achieving positive financial results. For employees, growth of shareholder value provides financial security for our families and the pursuit of happiness for our future. LEADING IN TECHNOLOGY & INNOVATION We are committed to providing patients and health care providers with the highest quality devices and optimal cost-effective solutions. We accomplish this through the relentless exploration of new ideas and approaches that allow us to address new clinical challenges for our customers and patients. SUSTAINING A WINNING CULTURE Patients First. Our patients and customers are the motivation for all that we do and achieving our mission is dependent on their well-being. We must always act with integrity and honor and demand the best of ourselves. We work hard, have faith in each other, and have fun celebrating the patient success stories.

32 STEMI FEASIBILITY STUDY APPROVED 32 FDA approval of feasibility study to evaluate Impella CP use patients with ST segment elevation myocardial infarction (STEMI), without cardiogenic shock Hypothesis: Unloading may have impact on infarct size related to reperfusion injury in STEMI patients 50 patients at up to 10 sites, 2 arms. Initial Impella support and randomized to immediate PCI vs. 30min unloading prior to PCI Initiated first half of calendar 2017 and expected to complete within 18 months STEMI patient represents a potential new patient indication (200k / year) that may benefit from Impella unloading the left ventricle

33 Incremental Cost IMPELLA IS A COST-EFFECTIVE THERAPY 33 Costs QALY Costs QALY 0 Protect II ICER $39,389/QALY Costs QALY Emergent ICER -$134,932/LYG DOMINANT 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 Quality Adjusted Life Years/LYG

34 A GROWING POPULATION APPROPRIATE FOR PCI M 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

35 Death Rate, % AMI SHOCK MORTALITY UNCHANGED IN > 20 YEARS 35 High In-Hospital Mortality During AMI Cardiogenic Shock 3 STEMI Cardiogenic Shock in Medicare Age Increasing 2 56, ,969 53% Age >65 only, excludes non-medicare population Does not include all other forms of shock 1. 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