Recovering Hearts. Saving Lives.

Transcription

1 Recovering Hearts. Saving Lives ṬM Michael Minogue Chairman, President, & CEO January 2019

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 are indicated for providing temporary (< 6 hours) ventricular support during elective or urgent high risk percutaneous coronary interventions (PCI) performed in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 and the Impella CP 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 Impella 2.5, Impella CP, Impella 5.0, and Impella LD Catheters, in conjunction with the Automated Impella Controller, 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, or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures.* The intent of the Impella Support Systems 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, and The Impella Pediatric TM are in development and are not approved for use or sale in the US. The ABIOMED logo, ABIOMED, Impella 2.5, Impella CP, Impella RP, Impella 5.0, and Impella LD are registered trademarks of Abiomed, Inc. in the U.S.A. and certain foreign countries. Impella ECP, Impella 5.5, Impella BTR, cvad Study and Recovering hearts. Saving lives. is a trademark of Abiomed, Inc.

3 TREATING THE HEART OPEN OR PERCUTANEOUS? 3 OPEN CHEST PROCEDURES PERCUTANEOUS PROCEDURES HEART SURGERY SUITE WITH HEART & LUNG MACHINE CATHERIZATION LAB (CATH) ENABLES PERCUTANEOUS TREATMENT

4 PERCUTANEOUS, MINIMALLY INVASIVE PROCEDURES 4 PLUMBING PUMP STENTS / PCI > 1 million placed in CY 2018 CATH LAB ELECTRICITY PACEMAKERS / ICDS > 400,000 implanted in CY 2018 IMPELLA HEART PUMPS ~ 25,000 implanted per year* VALVE TAVR ~ 70,000 placed in CY 2018 Enables high-risk PCI cath lab procedures Therapy that protects, supports and recovers heart muscle 1) ACC/AHA Heart Disease and Stroke Statistics; U.S. census data, 2010; Company websites and sell-side analyst models *Current Run Rate

5 THE ABIOMED MISSION 5 To recover heart muscle and save lives with percutaneous heart pump technologies for high-risk patients and enable better, minimally invasive procedures Tim Justin

6 ABIOMED AT A GLANCE (NASDAQ: ABMD) 6 EUROPEAN HQ: AACHEN, GERMANY 71,000 sq. ft. with Manufacturing JAPANESE HQ: TOKYO First Patient Treated: 2017 GLOBAL HQ: MASSACHUSETTS, USA 200,000+ sq. ft. with Manufacturing Founded in 1981 Global Employees ~1,350 Key Medical Device Countries: Impella Products Approved; ABMD Direct Distribution/Coverage; Dedicated Impella Reimbursement Next Tier Opportunities: Impella Products Approved; No / Limited Distribution Coverage

7 FY 2019 Upgraded Guidance: STRONG REVENUE GROWTH AND GROSS MARGINS (~83%) Expanded PMA Indications 33% ~31% ~780 7 FDA Approval Protected PCI 43% FDA Approval AMI / CGS 35% Abiomed Revenue ($M) Impella Acquisition 48% 14% % 51 FDA 510k Clearance 16% 24% % 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 18 FY 19E * New Management: Calendar year 2004; Fiscal Year 2005 (April 1 March 31)

8 STRONG PROFITABILITY, BALANCE SHEET AND NO DEBT 8 GAAP OPERATING INCOME ($M) GAAP OPERATING MARGIN CASH ($M) 1 ~450 ~226* 26.5% ~29%* % 20.2% % % FY'14 FY'15 FY'16 FY'17 FY'18 FY'19E * Assumes midpoint of guidance range 1. Cash, cash equivalents, short and long term marketable securities FY'14 FY'15 FY'16 FY'17 FY'18 FY'19E 80% 83% 85% 84% 83% 83%E Gross Margin FY'14 FY'15 FY'16 FY'17 FY'18 Q3'19E Debt: $0

9 ABIOMED ANNOUNCES PRELIMINARY FY 19 Q3 REVENUE 9 Abiomed Announces Preliminary Q3 FY 2019 Revenue of $201 Million, Up 30% Over Prior Year: Preliminary unaudited U.S. Impella product revenue grew 27% to approximately $165.7 million from $130.7 million in the prior fiscal year. Outside the U.S., Impella product revenue for the quarter totaled $27.5 million, an increase of 59% compared to revenue of $17.3 million during the same period of fiscal 2018 The company is increasing its 2019 revenue guidance to approximately $780 million, from a range of $765 million to $770 million, an increase in revenue of approximately 31% from the prior year Other operating details of third quarter fiscal 2019 will be provided on the company s earnings call on January 31, 2019

10 ABIOMED: THE HEART RECOVERY COMPANY Creating the new Field of Heart Recovery with the Impella heart pump platform 2. Solving a clinical crisis for large and growing patient populations 3. Improving patient outcomes by leading in clinical research, education and 24 x 7 hospital support 4. Sustaining long-term growth driven by innovation and strong execution

11 IMPELLA HEART PUMPS: BREAKTHROUGH TECHNOLOGY 11 Exclusive FDA Approvals: High-Risk PCI (2015) AMI Cardiogenic Shock (2016) Impella RP for Right Heart Failure (2017) Cardiomyopathy Shock (2018) Expanded High-Risk PCI; SmartAssist TM (2018) Medicare Designated DRG Codes: CMS reimbursement for implant, explant, transfer & biventricular Impella at 1,300+ US hospitals Approved in Europe (CE Mark 2002) Approved in Japan (PMDA 2016) >100,000 patients treated world-wide 8 Clinical Guidelines; >550 publications >$500M & 20 years of R&D; 597 patents & 442 patents pending* *Global patent statistics as of January 7, 2019

12 IMPELLA HEART PUMPS ENABLE HIGH-RISK PROCEDURES 12 PATIENT HEMODYNAMIC METRICS DURING HIGH-RISK PCI UNLOADS THE HEART MUSCLE DURING PCI Impella 2.5 On MAP 110 mmhg -8% -10% -12% MAP 86 mmhg 97 mmhg -15% -23% -51% Organ failure 42 mmhg Justin Redman Impella 2.5 Patient Case Start Balloon Stent Inflation 15 sec 30 sec 45 sec * Physiologic computational modeling of patient, Am J Physiol 1991;260 : H146-H157

13 THE IMPELLA HEART PUMP CATHETER PLATFORM 13 Femoral Insertion AIC (Automated Impella Controller TM ) Venous Insertion for Right-Heart Impella RP Impella 2.5 Impella CP Pipeline Devices*: Impella 5.5 TM CE Mark 2018 Axillary Insertion Impella ECP TM Impella 5.0 TM / LD TM Impella BTR TM SmartAssist TM 24 x 7 Support Onsite, On-call, Online Impella Connect * Impella pipeline devices in development and not approved for use or sale.

14 ABIOMED: THE HEART RECOVERY COMPANY Creating the new Field of Heart Recovery with the Impella heart pump platform 2. Solving a clinical crisis for large and growing patient populations 3. Improving patient outcomes by leading in clinical research, education and 24 x 7 hospital support 4. Sustaining long-term growth driven by innovation and strong execution

15 CORONARY ARTERY DISEASE (CAD) & HEART FAILURE (HF) CRISIS: NEW TREATMENT OPTIONS WITH IMPELLA ELECTIVE URGENT 15 #1 CAUSE OF DEATH IN U.S.: CAD / HF >15M people with CAD; 875,000 deaths per year from CAD 47% OF WOMEN & 36% OF MEN OVER 45 YRS: will die within 5 years of their first heart attack 1 #1 CARDIAC MORTALITY RISK: CARDIOGENIC SHOCK ~50% mortality rate for last 20+ years 2 #1 U.S. HEALTH EXPENDITURES: HEART CARE COSTS $555B in 2016 to $1.1T by * 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. EMERGENT (CARDIOGENIC SHOCK)

16 $6B U.S. CURRENT ADDRESSABLE MARKET (CAM), ~11% PENETRATION 16 The Current Addressable Market (CAM) includes FDA approved products for patients currently in need, but does not include new expanded indications* from 2018 or future indications or the Total Addressable Market (TAM). The company expects to achieve 100% of the CAM. U.S. ANNUAL NUMBER OF HIGH RISK PATIENTS: PENETRATION PROTECTED PCI 1 EMERGENT 2 121,000 (ELECTIVE + URGENT) 100,000 (SHOCK) 11% 231,000 RIGHT-SIDE FAILURE 3 10,000 IMPELLA RP PATIENTS CAM OUS 4 GERMANY 25,000 PENETRATION 17% JAPAN 50,000 IMPELLA IN 48 OF 350 HOSPITALS 1% * Expanded indications include: Expanded FDA Indication for High Risk Percutaneous Coronary Intervention (PCI) Procedures for support as appropriate in patients with severe coronary artery disease, complex anatomy and extensive comorbidities, with or without depressed ejection fraction (EF). And expanded FDA Indication for Cardiomyopathy with Cardiogenic Shock. Please see all Abiomed legal disclaimers for more information. 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. 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. ; German Heart Report, 2015

17 PROTECTING & RECOVERING HEART MUSCLE 17 PROTECTED PCI / ELECTIVE & URGENT CARDIOGENIC SHOCK / EMERGENT OTHER RIGHT-SIDE SUPPORT

18 ABIOMED: THE HEART RECOVERY COMPANY Creating the new Field of Heart Recovery with the Impella heart pump platform 2. Solving a clinical crisis for large and growing patient populations 3. Improving patient outcomes by leading in clinical research, education and 24 x 7 hospital support 4. Sustaining long-term growth driven by innovation and strong execution

19 FDA APPROVED INDICATIONS: SAFE & EFFECTIVE PROTECTED (HIGH RISK) PCI (ELECTIVE + URGENT): APPROVED BY FDA 2015 * EXPANDED INDICATIONS 2018 CARDIOGENIC SHOCK (EMERGENT): APPROVED BY FDA 2016 EXPANDED INDICATIONS 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.

20 IMPELLA IMPROVING OUTCOMES & LOWERING COSTS 20 IMPROVES PATIENT QUALITY OF LIFE 22-32% Improvement in Ejection Fraction 1,2 58% Reduction in Class III and IV Heart Failure (NYHA) 1 6x Reduction in Acute Kidney Injury (AKI) and Need for Dialysis 6 IMPROVES PATIENT OUTCOMES & SURVIVAL 29-47% Reduction in Adverse Events at 90 Days (Death, Stroke, MI, and/or Repeat Revascularization) 1,25 77% Survival rate in Cardiogenic Shock with 99% native heart recovery in 2018 NCSI Collaborators Study % Reduction in 30-day Mortality 7 COST EFFECTIVE THERAPY 2-12 Days, & 52% Reduction in Hospital Stay9,15,17,18,19, 20, 21, 22, 23 & Reduction in Repeat Admission at 90 days 16 $45K, $54K, $22K Reduction in Hospital Costs per Case in AMI, CAD and Lower Cost without AKI 8,24 $887K Reduction in Hospital Charges to Avoid Heart Transplant/Implantable LVAD 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 Dangas et al, Am. Journ of Cardiol. 2014: 113(2): O Neill, Acute Coronary Syndromes, Cardiogenic Shock, and Hemodynamic Support, TCT Milliman 2017 US Organ and Tissue Transplant Cost Estimates and Discussion

21 IMPELLA INNOVATION AND SUSTAINABLE GROWTH 21 TODAY FUTURE* PRODUCTS IMPELLA 2.5 IMPELLA CP IMPELLA 5.0 IMPELLA RP SMARTASSIST TM IMPELLA 5.5 TM CE MARK 2018 IMPELLA ECP TM IMPELLA BTR TM WEARABLE DRIVER PROTECTED PCI CARDIOGENIC SHOCK RIGHT & LEFT SIDE SUPPORT ADDITIONAL INDICATIONS STEMI (INFARCT REDUCTION) HEART FAILURE (CLASS III) INDICATIONS 200K U.S. PATIENTS 100K U.S. PATIENTS U.S. GERMANY JAPAN REST OF WORLD GEOGRAPHIES 231K PATIENTS 25K PATIENTS 50K PATIENTS * 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.

22 IMPELLA 5.5 TM : AMBULATION WITH AXILLARY APPROACH 22 AXILLARY IMPLANT Impella 5.0 Impella 5.5 TM Impella 5.5 TM Patient Implant Germany 9 Fr catheter 19 Fr pump Real-Time Patient metrics >5,000 Impella 5.0 Implants Impella 5.5 : Forward Flow Heart Pump Designed for Axillary Implant and Weaning Full hemodynamic support > 6.0 L/min Impella 5.0 Patient CE Mark (2018) currently for 30 days of use, US timeline forecasted end of calendar 2019 Designed for longer duration with Impella Connect and SmartAssist TM Note: Impella 5.5 TM is not approved for use or sale in the United States. The Impella 5.0 is intended for short term use of 6 days. DISCUSSION OF DEVICES IN DEVELOPMENT

23 IMPELLA ECP: EXPANDABLE CARDIAC POWER 23 Smallest Percutaneous Heart Pump: 9Fr catheter, 9Fr pump expands to 18Fr Designed for flows >3.5 L/min 9 Fr catheter and pump on insertion Designed for Protected PCI (6-12 hour duration) on AIC console First in Man pending OUS Aortic Valve Plane Pump inside LV, only smooth polyurethane membrane touches aortic valve (Patented) Pigtail insertion (Patented) Note: Impella ECP is in development and is not approved for use or sale. DISCUSSION OF DEVICES IN DEVELOPMENT

24 STEMI DTU FDA FEASIBILITY STUDY THESIS: UNLOADING REDUCES REPERFUSION* INJURY & INFARCT SIZE 24 LARGE STEMI INFARCTS DRIVING GROWING EPIDEMIC OF HEART FAILURE INFARCT UNLOADING ANIMAL STUDY Impella OFF UNLOADING ACTIVATES CARDIO-PROTECTION Impella ON Within 5 years, 76% have Heart Failure ** Flameng et al 2000: JACC 2001 STEMI Study Details (50 patients / 15 sites) *Myocardial Reperfusion Injury, Yellon, NEJM 2007, 357:1121 This indication is not approved and is currently being studied. Esposito M, et al JACC 2018 DISCUSSION OF POTENTIAL FUTURE FDA APPROVAL FOR USE

25 STEMI PILOT STUDY SUCCESSFULLY COMPLETED 25 Pilot study to evaluate Impella CP for patients with STEMI w/o shock Hypothesis: Unloading heart before PCI may reduce reperfusion injury Safety Concern: Delaying PCI opposite of current guidelines, not feasible. N=50, 2 arms. Impella support, randomized with immediate PCI or delayed PCI +30 min Pilot Study Confirmed: Safe and Feasible Unloading the left ventricle for 30 minutes prior to reperfusion appears to reduce infarct size as a percentage of area at risk among patients with an ST sum greater than 6 STEMI Pivotal RCT Study planned for 2019 This indication is not approved and is currently being studied.

26 ABIOMED: THE HEART RECOVERY COMPANY IMPELLA : REVOLUTIONIZING THE STANDARD OF CARE 26 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

27 27 JPM APPENDIX

28 DOOR-TO-BALLOON TO DOOR-TO-UNLOADING 28 DOOR REPERFUSE PRE-CLINICAL ANIMAL STUDY DTB < 90 min 43% Reduction 1 DOOR UNLOAD REPERFUSE DTU < 90 min 30 min Cardioprotection time 1. Esposito M, et al JACC Kapur N, et al, Circulation Ahead of Print 2018, Region outlined in blue represents Infarcted Myocardium This indication is not approved and is currently being studied.

29 UNLOADING HAS THE POTENTIAL TO REDUCE INFARCT SIZE FOR HEART ATTACK PATIENTS 29 Reperfusion alone 30 mins unloading before reperfusion Pre-Clinical 1 Animals U-IR Infarct U-DR DTU Pilot 2 Human U-IR: Unloading followed by Immediate (11 minutes) Reperfusion U-DR: Unloading for 30 minutes with Delayed Reperfusion N=50, 2 arms 25 patients 1. Esposito M, et al JACC Kapur N, et al, Circulation Ahead of Print 2018, This indication is not approved and is currently being studied.

30 ABIOMED PRINCIPLES 30 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.

31 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

32 MACCE (%) PROTECTED PCI: IMPELLA REDUCES ADVERSE EVENTS & IMPROVES QUALITY OF LIFE MACCE = Death, Stroke, MI, Repeat revasc IABP N=211 29% reduction 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

33 IMPROVEMENT IN QUALITY OF LIFE POST PROTECTED PCI 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):

34 HIGH-RISK PCI PATIENTS FACE HIGH POST-DISCHARGE ADVERSE EVENT RATES 34 ENDPOINTS AT 90 DAYS 18.6% p= % 9.8% 12.9% p= % 7.0% 47% reduction in adverse events at 90 days with Impella device IABP Impella IABP Impella MACCE (Death/Stroke/MI/Repeat Revascularization) Irreversible MAEs (Death/Stroke/MI) FDA Randomized Controlled Trial: Protect II (Impella 2.5 ) O Neill WW et al. Circulation Oct 2:126(14):

35 META-ANALYSIS OF COMPLETE VS. INCOMPLETE REVASCULARIZATION 35 POOLED PCI STUDIES Relative Risk [95% CI] p-value Mortality 0.72 [0.64, 0.81] < in patients with multivessel CAD undergoing revascularization with CABG or PCI, CR was associated with lower morbidity and mortality. MI 0.80 [0.71, 0.91] Repeat Revasc 0.72 [0.63, 0.81] < Complete revasc better Incomplete revasc better Garcia et al, JACC Vol. 62, No. 16, 2013

36 Survival Rate AMI CARDIOGENIC SHOCK: IMPELLA LINKED TO REDUCED MORTALITY & REDUCED COSTS 30-DAY SURVIVAL 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

37 Death Rate, % AMI SHOCK MORTALITY IMPROVING WITH IMPELLA BEST PRACTICE PROTOCOL DERIVED FROM IQ, CVAD & NCSI 37 HIGH IN-HOSPITAL MORTALITY DURING AMI CARDIOGENIC SHOCK 3 STEMI CARDIOGENIC SHOCK IN MEDICARE AGE INCREASING Hospitals with Best Practice Protocol 77% 4 ~75% 5 36,969 53% 56, NCSI 4 IQ 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

38 THE SCIENCE FOR THE NEW FIELD OF HEART RECOVERY 38 DECREASED O 2 DEMAND INCREASED O 2 SUPPLY DECREASED LUNG CONGESTION UNLOADING ACTIVATES CARDIO-PROTECTION Impella OFF Pre-Impella Implant Impella ON + 30 Hours on Impella Meyns B, et al. J Am Coll Cardiol 2003 Aqel RA, et al. J Nucl Cardiol 2009 Andersen M, et al. TCT 2012 Esposito M, et al JACC 2018 Decreased lung congestion is not a current indication. Cardio-protection and reduction of infarct size is not on label. The cellular level cardio-protective effect has only been studied in animal research. This impact will be researched further in humans in the FDA STEMI DTU Pilot and Pivotal Studies.

39 IMPROVING PATIENT OUTCOMES BY LEADING IN CLINICAL RESEARCH AND SHARING BEST PRACTICES 39 IMPELLA QUALITY (IQ) DATABASE 1 IDENTIFIES BEST PRACTICES TO IMPROVE OUTCOMES CVAD STUDY DATA 2 VALIDATES BEST PRACTICES TO IMPROVE OUTCOMES HRPCI Elective & Urgent 48% (n=36,654) Cardiogenic Shock 35% (n=26,800) Other 18% (n=13,788) HRPCI Elective & Urgent 46% (n=2,316) Cardiogenic Shock 41% (n=2,034) Other 13% (n=661) COMMERCIAL QUALITY ASSURANCE DATABASE IRB Exempt / HIPAA Compliant ~77,000 Patients, 1,307 US Impella Centers ( ) Reviewed by Heart Team physicians Ongoing for all Impella patients, outcomes to explant FDA PRE & POST MARKET STUDIES IRB Approved, prospective study with one year follow-up FDA definitions, audited for Pre & Post-Approval Studies Data collection on over 5,000 patients Independent physician steering committee 1. Abiomed Impella Quality (IQ) Database, Danvers MA 2. cvad Study Data of Patients Undergoing PCI for Acute Myocardial Infarction Complicated by Cardiogenic Shock as of August Cather Based Ventriculat Assist Device (cvad)

40 IMPROVING PATIENT OUTCOMES BY LEADING IN CLINICAL RESEARCH, EDUCATION AND 24 X 7 HOSPITAL SUPPORT 40 FDA STUDIES & APPROVALS 6 FDA STUDIES, 5 POST-MARKET STUDIES PHYSICIAN-LED STUDIES / INITIATIVES >550 CLINICAL PUBLICATIONS IMPELLA CONNECT TM REAL-TIME PATIENT MONITORING 24 X 7 High-Risk PCI: Protect I & Protect II RCT Cardiogenic Shock: Recover I & Recover II RCT Right Heart Failure: Recover Right WIP - Heart Attack: STEMI DTU Pilot RCT, Pivotal RCT ~2019 National Cardiogenic Shock Initiative (NCSI): 80+ hospital centers DanGer Shock Study (ABMD Sponsored) Complex High-Risk Indicated Patients (CHIP) Training & Education on Hemodynamics (TEACH) Patients in the cloud Ease of use & patient management onsite expertise Artificial Intelligence algorithms to wean

41 IMPELLA CONNECT & SMARTASSIST TM 24 X 7 SUPPORT 41 Impella Connect Online SmartAssist TM Abiomed Clinical On-Call Center Real-Time Patient metrics Physician Patient AIC with SmartAssist TM and Weaning Algorithms Nurse Station Abiomed Clinical Team Onsite

42 INVESTING IN EDUCATION & FIELD OF HEART RECOVERY 42 PHYSICIAN EDUCATION EDUCATION PROGRAMS AND DOSSIERS PROTECTEDPCI.COM / IMPELLA.COM MOBILE LEARNING LAB DTC: TV COMMERCIALS HEART RECOVERY INSTITUTE

43 CREATING THE FIELD OF HEART RECOVERY IN JAPAN Cultural aversion to heart transplant/ open chest and strong desire for myocardial recovery HEART FAILURE (HF) POPULATION GROWING WITH IMPROVEMENT IN AMI SURVIVAL* Hemodynamic science expertise and IABP Class III (not recommended) Japanese Guidelines Impella Patient Growing clinical need: Complex, high risk PCI market ~265K PCIs/yr ~133M total population, >1.5M with HF 50,000 patients per year ; ~1% CAM penetration 48 of 350 heart hospitals * Annual Report of Ministry of Health, Labor and Welfare (MHLW) Annual Reports,

44 Incremental Cost IMPELLA IS A COST-EFFECTIVE THERAPY 44 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

45 IMPELLA BRIDGE TO RECOVERY (BTR TM ) HEART PUMP: HIGHER FLOW, LONGER DURATION, HOME USE 45 AXILLARY IMPLANT IMPELLA BTR * IMPLANTABLE LVAD WITH STERNOTOMY ~19 Fr pump Real-Time Patient metrics ~9 Fr catheter Wearable Driver Minimally invasive, forward flow, weanable heart pump for Heart failure Full support, over 6.0 L/min with SmartAssist TM Designed for discharge & duration up to 1 year Allows for NEW Heart Recovery/Remodeling therapy with adjunctive therapies (new heart failure drugs, stem cells) or next treatment Cores Out Heart ~100,000 U.S. potential patient population Note: Impella BTR TM is in development and not approved for use or sale in the United States. DISCUSSION OF DEVICES IN DEVELOPMENT

46 IMPELLA HEART PUMPS ENABLE PCI AND SUPPORTS/RECOVER HEART MUSCLE 46 IABP: 1976 IMPELLA IMPLANTABLE LVAD** Not a Heart Pump Historic Use: ~130K/yr in U.S. Percutaneous Insertion Unloads Ventricles Requires Sternotomy Cores Out Left Ventricle * IABP grandfathered in, on market before creation of 510k clearance ** LVAD= Left Ventricular Assist Device