2018 TCT Investor Update

Transcription

1 TCT Investor Update September 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. 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. 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, and Impella BTR TM are in development and are not approved for use or sale in U.S. 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 Registry and Recovering hearts. Saving lives. is a trademark of Abiomed, Inc.

3 ABIOMED 2018 TCT INVESTOR UPDATE MICHAEL R. MINOGUE, ABIOMED CHIEF EXECUTIVE OFFICER, PRESIDENT & CHAIRMAN

4 ABIOMED PRINCIPLES PATIENTS FIRST 4 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.

5 ABIOMED PRINCIPLES PATIENTS FIRST 5 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. 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. 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. 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.

6 ABIOMED HAS BUILT THE FIELD OF HEART RECOVERY Abiomed Founded s BVS Earns FDA Approval for Recovery (First VAD) Thorsten Siess Invents Impella Mike Minogue Becomes Aboimed CEO AB5000 Earns FDA Approval for Recovery 2002 Impella Earns CE Marking and Treats First Patient Abiomed Acquires Impella 2007 PROTECT II Impella RCT Begins 2008 Impella Receives 510k Clearance 2015 Impella Earns FDA PMA High Risk PCI 2016 Impella Earns FDA PMA Cardiogenic Shock for Native Heart Recovery 2017 Impella Earns FDA PMA Impella RP Impella Launches in Japan 2018 Impella Earns FDA PMA Multiple Expanded Indications CMS Adds Designated DRG Code (215) OVER 70,000 PATIENTS TREATED IN THE U.S.

7 CURRENT IMPELLA HEART PUMP FAMILY PLATFORM 7 Impella 2.5 Impella CP Impella 5.0 Impella RP Impella 5.5 TM* Catheter Diameter: 9 Fr Flow Rate up to: 2.5L/min Catheter Diameter: 9 Fr Flow Rate: >4.3L/min Catheter Diameter: 9 Fr Flow Rate up to: 5.0L/min Catheter Diameter: 11 Fr Flow Rate up to: >4.0L/min Automated Impella Controller CE Mark:* Catheter Diameter: 9 Fr Flow Rate up to: >5.5L/min * Impella 5.5 heart pump received European CE Marking April Impella 5.5 is not approved for use or sale in the U.S.

8 ABIOMED INNOVATION ROADMAP 8 Expandable Introducer Sheath Future Pump Development 9Fr Impella ECP Impella 5.5 Impella BTR Impella CP with SmartAssist Single Fluid Line for Set-up & Management Designed to achieve Repositioning Without Need for Echo Peak Flow Up to 4.3L/min Reaccess Sheath Real-time Pump Metrics LVP & CPO on AIC Impella Connect DISCUSSION OF DEVICES IN DEVELOPMENT

9 9 FUTURE INNOVATIONS FOR IMPELLA DEVICES: IMPELLA WITH SMART ASSIST TM DR. DAVID WEBER, ABIOMED CHIEF OPERATING OFFICER

10 SMART ASSIST PLATFORM 10 Improving outcomes with real-time intelligence SmartAssist hemodynamic sensors to intelligently position, manage and wean Impella Connect: Real-time information to the cloud so that remote personnel can be more responsive to patient needs

11 SMARTASSIST HEMODYNAMIC SENSORS 11 Optical Sensor Senses to Aortic pressure (Ao) Intelligent pump metrics 1 on console to position, manage, wean Displays LV waveform and average EDP Micro-axial motor Senses pressure difference between Aorta and Left Ventricle Real-time in-vivo pump flow Displays real-time invivo pump flow Displays continuous Cardiac Output and CPO trends 1. FDA Approved, PMA Supplement, 2018

12 HEMODYNAMIC EFFECTS OF IMPELLA 12 Micro-axial motor + Optical sensor SmartAssist pump metrics Cardiac Output MAP LVEDP and LVEDV Wall Tension Mechanical Work Coronary Perfusion Microvascular Resistance Cardiac Power Output End Organ Perfusion O 2 Supply O 2 Demand Unloading to Myocardial Recovery Fincke J, et al. Am Coll Cardiol 2004 den Uil CA, et al. Eur Heart J 2010 Mendoza DD, et al. AMJ 2007 Torgersen C, et al. Crit Care 2009 Torre-Amione G, et al. J Card Fail 2009 Suga H. et al. Am J Physiol 1979 Suga H, et al. Am J Physiol 1981 Burkhoff D. et al. Am J Physiol Heart Circ 2005 Burkhoff D. et al. Mechanical Properties Of The Heart And Its Interaction With The Vascular System. (White Paper) 2011 Sauren LDC, et al. Artif Organs 2007 Meyns B, et al. J Am Coll Cardiol 2003 Remmelink M, et al. atheter.cardiovasc Interv 2007 Aqel RA, et al. J Nucl Cardiol 2009 Lam K,. et al. Clin Res Cardiol 2009 Reesink KD, et al. Chest 2004 Valgimigli M, et al.catheter Cardiovasc Interv 2005 Remmelink M. et al. Catheter Cardiovasc Interv 2010 Naidu S. et al. Novel Circulation.2011 Weber DM, et al. Cardiac Interventions Today Supplement Aug/Sep 2009

13 NATIVE HEART ASSESSMENT DURING WEANING 13 Increasing native heart output Decreasing pump flow Metrics are for information purposes only an are not intended for diagnostic use. Values must be verified independently using an approved diagnostic device, and must not be used for patient monitoring.

14 EASIER PUMP POSITIONING 14

15 IMPELLA CONNECT 15 Automated Impella Controller with Impella Connect Cloud-based, HIPAA compliant, wireless transmission of the display screen over a secure server. Real-time remote viewing of Impella status by clinicians, Abiomed field teams or the Abiomed Clinical Support Center staff. Improving responsiveness by connecting remote support personnel Impella Connect is available at select centers in the US

16 IMPELLA CONNECT REAL-TIME RESPONSE 16 Abiomed Clinical Call Center Abiomed Support Center Nurse Station Abiomed Clinical Team Patient Abiomed Clinical Team Physician s Office Physician Office Improving responsiveness by connecting remote support personnel Impella Connect is available at select centers in the US

17 ABIOMED: A LONG RUNWAY FOR PROFITABLE GROWTH Existing Opportunity: The Field of Heart Recovery Protected PCI Program: 10% Penetration of 121k Potential U.S. Patients (+ FDA Expansion) AMI Cardiogenic Shock: 10% Penetration of 100k Potential U.S. Patients (+ FDA Expansion) Impella RP: PMA Approved ; Commercially Launched ; Potential 10k U.S. patients Germany: 12% Penetration of 25k Potential Patients 2. Mid / Long Term Opportunity: Japan: Commercially Launched; <1% Penetration of 50k Potential Patients New Products: Optical Sensor, Impella Connect, Impella 5.5, Impella ECP, Impella BTR STEMI DTU: FDA Feasibility Study Completed; Presentation at AHA (Nov 2018); Goal to move to Pivotal RCT Trial; 200k Potential U.S. Patients New geographies (ROW outside of U.S., Germany, Japan)

18 18 Q&A

19 19 APPENDIX

20 IMPELLA DEVICE SPECIFICATIONS 20 Impella 2.5 Impella CP Impella 5.0 Impella RP Flow (Liters / Min) < 2.5 L/min < 4.3 L/min < 5 L/min > 4 L/min Catheter Size 9F 9F 9F 11F Pump Insertion Size 12F 14F 21F 22F Approved Duration 4 days (US) 5 days (EU) 4 days (US) 5 days (EU) 6 days (US) 10 days (EU) 14 days (US,EU) FDA Approved Indications High Risk PCI AMICS/PCCS High Risk PCI AMICS/PCCS AMICS/PCCS AMICS/PCCS/ LVAD/HTx Insertion Sheath 13cm Peel-Away (femoral artery) 13 cm/25cm Peel-Away (femoral artery) 6 cm Peel-Away (axillary/femoral graft) 30cm (femoral vein) Valve Interaction Smooth Cannula Smooth Cannula Smooth Cannula Smooth Cannula