a tct investor breakfast: 2016abiomed-private.s3.amazonaws.com/assets/files/148293668764629… ·...

Recovering Hearts. Saving Lives.

ABIOMED TCT INVESTOR BREAKFAST: 2016COMMITTED TO IMPROVING OUTCOMES IN PROTECTED PCI AND CARDIOGENIC SHOCK


LEGAL DISCLAIMERSThis 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.

2

U.S. Food and Drug Administration Approvals

● The Impella 2.5™ System is a temporary (≤ 6 hours) ventricular support device 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 System 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 in pediatric or adult 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 www.protectedpci.com/hcp/information/isi and www.cardiodenicshock.com/hcp/information/isi.

Impella ECPTM, Impella CP® Next Generation, Impella 5.5TM, Impella BTRTM, The Impella PediatricTM, 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, Impella cVAD, Impella ECP and Recovering hearts. Saving lives. is a trademark of Abiomed, Inc.


INFORMATION INTENDED SOLELY FOR INVESTORS3

FOR INVESTORS ONLY

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.


TCT 2016 TAKEAWAYS:4

1. Existing Opportunity: “The Field of Heart Recovery”

Protected PCI Program: 6% Penetration of 121k potential U.S. patients

AMI Cardiogenic Shock: 6% Penetration of 100k potential U.S. patients

2. Mid-Term Opportunity:

Japan: 2nd largest med tech market ; Potential 50k patients

STEMI: Pilot Study FDA Approved. Goal to revolutionize AMI care (heart attack) ; 250k

potential U.S. patients

3. Long-Term Opportunity:

New products (fiber optic sensor, remote monitoring, Impella ECP, Impella 5.5, Impella BTR)

New geographies (ROW)


COMMITTED TO IMPROVING OUTCOMES IN PROTECTED PCI AND CARDIOGENIC SHOCK

DR. SETH BILAZARIAN, ABIOMED CHIEF MEDICAL OFFICER

ABIOMED TCT INVESTOR BREAKFAST: 2016


DR. SETH BILAZARIAN, CHIEF MEDICAL OFFICER, 2015 6

• 23 years in practice as Interventional Cardiologist, privileges at

Massachusetts General, Lahey Clinic, Lawrence General

• Served on the faculty as an instructor at Harvard Medical School,1995 - 2015

• Founded largest community based clinical cardiology research program in

Partners Healthcare, with 50 RCT FDA trials/studies

• FDA physician advisor and cardiac device panel member, 2008 - 2015

• Board certified in cardiovascular medicine, nuclear cardiology, vascular

ultrasound, interventional cardiology, vascular and endovascular medicine

• Blog on cardiology : “Practitioner’s Corner” established in 2009, on

theheart.org and Medscape

• Cardiosource World News: Top 10 Cardiologists Most Followed by

Cardiologists, #6, 2015

• Bachelor of Science in Engineering in Chemical Engineering from Tufts

University

• MD from University of Massachusetts Medical School, internship and

residency at Johns Hopkins Hospital, and cardiology/interventional cardiology

fellowship at Boston University Hospital


NEW HIGH RISK PCI INDICATION APPROVED BY FDA

MARCH 23, 2015Impella 2.5

7

FOR INVESTORS ONLY


UPDATED 2015 & 2016 HIGH RISK PCI CONSENSUSACC/SCAI/HFSA/STS EXPERT CONSENSUS, ACC INTERVENTIONAL SCIENTIFIC COUNCIL

FOR INVESTORS ONLY

8


ISCHEMIC HEART DISEASE PUBLICATIONS

“ an evolution of contemporary interventional cardiology is

necessary to treat the increasingly higher-risk patients with

whom we are confronted.”

Revascularization is Superior: “In a cohort of patients with

ischemic cardiomyopathy, the rates of death from any or

cardiovascular causes, and death or hospitalization for

cardiovascular causes were significantly lower over 10 years

among patients who underwent CABG than among those who

received medical therapy alone.”

Kirtane et al, Circulation 2016

Velazquez et al, New England Journal of Medicine 2016

“The majority of patients hospitalized for new-onset HF did

not receive testing for ischemic CAD either during

hospitalization or within 90 days, …suggests significant

underutilization of ischemic CAD assessment.”

Doshi et al, Journal of the American College of Cardiology 2016

FOR INVESTORS ONLY

9


CHESS VS. SPEED CHESS

During PCI..

• Unplanned events occur with

equipment or patient behavior

• The response of hearts with poor

cardiac reserve can force “in and

out” placement of stents and not

complete revascularization

• Hemodynamic support helps

avoid early termination, especially

for patients who are surgical

turndowns

Navin Kapur, MD TCT 2015FOR INVESTORS ONLY

10


PROTECTED PCI AWARENESS: PATIENT IDENTIFICATION11

TCTMD Panel Discussion Clinical Dossier

Referral Outreach ProgramMobile Learning Lab

ProtectedPCI.com

Key Partners

FOR INVESTORS ONLY


AMI CARDIOGENIC SHOCK FDA PMA APPROVAL

13

CARDIOGENIC SHOCK INDICATION APPROVED BY FDA

APRIL 7, 2016

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 heart pumps stabilize the patient's hemodynamics, unload the left ventricle, perfuse

the end organs and allow for recovery of the native heart.

Impella® is the only

percutaneous heart pump

proven safe and effective for

hemodynamic stabilization to

enable Heart Recovery

FOR INVESTORS ONLY

14

Progressive

Myocardial Dysfunction

End Organ

Failure

REVERSE THE CARDIOGENIC SHOCK SPIRAL

Impella Now FDA Approved for Cardiogenic Shock Therapy

Ischemia

End Organ Perfusion

Myocardial

Recovery

Patients

Reverse Spiral

Cardiac Output

MAP

Death Spiral of

Cardiogenic Shock

Cardiac Power Output

Cardiogenic Shock Identifiers

• SBP <90 mmHg or on

Inotropes/Pressors

• Cold, clammy, tachycardia

• Lactate elevated >2 mmoI/L

Cardiogenic etiology evaluation

• EKG (STEMI / NSTEMI)

• Echocardiography

• PA catheter, Cardiac Output, CPO,

CI, PCWP, SvO2

FOR INVESTORS ONLY

15

INCIDENCE OF CARDIOGENIC SHOCK GROWING

STEMI Cardiogenic Shock in

Medicare Age Increasing2

Cardiogenic Shock in

STEMI Increasing1

Nationwide Inpatient Sample Databases

2010 2014

36,969

56,508

53%

Age 65 only, excludes non-Medicare population

1. Kolte D, et al. J Am Heart Assoc. 2014;3(1):e000590.

2. Centers for Medicare and Medicaid database, MEDPAR FY14.FOR INVESTORS ONLY

16

LIMITATIONS OF CONVENTIONAL THERAPY

1- Samuels LE et al , J Card Surg. 1999

2- Thiele H et al. NEJM 2012 - Clinicaltrial.gov # NCT00491036

IABP-SHOCK II

Randomized Controlled Trial2N = 600

Mortality Risk with

Inotropes/Vasopressors1

N = 40

IABP (n=301)

Medical Therapy (n=299)41.3%

39.7%

FOR INVESTORS ONLY

17

SHORT-TERM MCS LINKED TO REDUCED MORTALITY & REDUCED COSTS

Stretch et al. JACC 2014

“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.”

O’Neill, et al., J. Int. Cardiol, 2014

1.0

0.8

0.6

0.4

0.2

0 5 10 15 20 25 30

Su

rviv

al

Rate

IABP/Inotropes Pre-

PCI

Impella® Pre-PCI

Days from Initiation of Impella

Log-Rank, P=0.004

30-Day Survival

cVAD Registry™*

N=154

FOR INVESTORS ONLY

“ 2007 to 2011 use of pVADs increased 1,511% with a

mortality decrease from 41% to 33%. Hospital costs also

declined.”

18

ABIOMED IMPELLA QUALITY (IQ) PROGRAM:

IMPROVING OUTCOMES IN PROTECTED PCI AND CARDIOGENIC SHOCK

19

ABIOMED IQ PROGRAM MISSION

+ =

Data

Analytics

Best

Practices

Standard

ProtocolsCase-Based

Learning

Goal

IQ Database

cVAD Registry

FDA Study Data

Identify insights

with a goal to

improve

outcomes

Algorithms & Order

Sets based on Best

Practices and

Appropriate Use

24/7 clinical

support

After Action

Reviews

Improved Survival

with Native Heart

Recovery

Improve real-world outcomes in Protected PCI and AMI Cardiogenic Shock patients through training,

education and utilization of clinical guidelines, protocols and best practices derived from observational

quality assurance data (IQ), IRB approved registry (cVAD) and IDE approved FDA studies

FOR INVESTORS ONLY

20

88% Recovery

91% Recovery

93% Recovery

0% to 33% 34% to 66% 67% to 100%

Impella Sites(282 sites supported >4 AMI/CGS patients)

Survival to

Explant

ABIOMED IQ DATABASE , AMI/CGS APRIL 2016 – OCT 2016

n=205 n=1142 n=644

SURVIVAL WITH HEART RECOVERY IN AMI SHOCK (FY’17)

N=1,991 patients

April 2016 to Oct 2016

1st Tercile 2nd Tercile 3rd Tercile

% Heart Recovery

% Bridge to next therapy

59% Average Survival

FOR INVESTORS ONLY

21

0% 50% 100%

50%

100%

NATIVE HEART RECOVERY BEST OPTION FOR PATIENT AND

PAYERS… IMPROVES QUALITY OF LIFE, LOWERS COST

Survival*

Native

Heart

Recovery

Impella1

Lowest Survival Tercile

88% Recovery1

2Middle Survival Tercile

91% Recovery2

3

Highest Survival Tercile

93% Recovery3

ECMOECMO Meta-analysis ‡

‡ Cheng et al. Annals of Thoracic Surgery, 2014 (meta-analysis of 20 studies, 1820 patients)

ECMO for AMI/CGS patient population is off-label per FDA indications

LVAD

Durable LVAD †

Intermacs 1 & 2

† Intermacs 1 and 2, Intermacs Registry, 2015

*Survival w/o heart recovery

requires implantable LVAD /

heart transplant

FOR INVESTORS ONLY

22

FIVE OBSERVATIONS THAT APPEAR TO CORRELATE WITH

IMPROVED OUTCOMES IN AMI CARDIOGENIC SHOCK

Use of Invasive Hemodynamic Monitoring (PA catheter)1

Timing of support (use of unloading with Impella® prior to PCI)2,3

Minimizing exposure to toxic inotropic medications4,5

Involvement of Abiomed team and support1

Protocol-driven support, weaning and escalation6,7

1. Data on file. Abiomed IQ Database, AMI/CGS April 2015-March

2016. Danvers, MA: Abiomed.

2. Data on file. USpella Registry Data. Danvers, MA: Abiomed

3. O'Neill WW, et al. Circulation. 2012;126(14):1717-1727.

4. Samuels LE, et al. J Card Surg. 1999;14(4):288-293.

5. De Backer D, et al. 2008.

6. Kormos RL, et al. 2006.

7. Korabathina R, et al. Catheter Cardiovasc Interv.

2012;80(4):593-600.

FOR INVESTORS ONLY

23

Escalate (and

Ambulate) or

Transfer

IMPELLA® BEST PRACTICES IN AMI CARDIOGENIC SHOCK

Identify(Protocols)

• SBP <90 mmHg or on Inotropes/Pressors

• Cold, clammy, tachycardia

• Lactate elevated >2 mmoI/L

Stabilize

Early • Impella Support pre-PCI

• Reduce Inotropes/Pressors

Complete

Revascularization

• PCI Guidelines based

in Cardiogenic Shock

Assess for Myocardial Recovery(Weaning and Transfer Protocols)

• ↑Cardiac Output

• ↑Cardiac Power Output

• ↑ Urine Output

• ↓ Lactate

• ↓ Inotropes

Myocardial

Recovery

No Recovery

• EKG (STEMI / NSTEMI)

• Echocardiography

• If available, PA catheter,

Cardiac Output, CPO, CI,

PCWP, SvO2

• Ongoing Left heart failure

• Assess for Right heart failure

Cardiogenic etiology evaluation

Metric #1Hemodynamic

Monitoring

Metric #2Stabilize Early with

Impellawith Complete

Revascularization

Metric #3Reduce Toxic

Inotropes

Metric #4Protocol-Driven

Wean or Escalate

Metric #5ABMD Support

FOR INVESTORS ONLY

24

8,500 patients

today

FDA Approval

April 2015

ABIOMED IQ PROGRAM FOR PROTECTED PCI

Protected PCI Patients in IQ Database Since FDA Approval

Micropuncture Access technique

Abiomed Support for initial case

Scheduling Cases allows advanced

Abiomed clinical support

Complete Revascularization

reduces post PCI adverse events

Post PCI support for severe LV

dysfunction or prolonged PCI

5 Observations that appear to correlate

with Improved Outcomes in Protected PCI

Quality Assurance Case Surveillance

Procedural Survival 99.5%

Bleeding related complications 0.9%

FOR INVESTORS ONLY

25

TCT 2016 TAKEAWAYS:



AMI Cardiogenic Shock Partnership: 6% Penetration of 100k potential U.S. patients








FOR INVESTORS ONLY


New England Journal of Medicine: 2003; 348:2007-18

Infarct = dead heart muscle

26

A GROWING HEART FAILURE POPULATION… WHY?

American Heart Association 2015 Statistics:

47% of women and 36% of men will die within 5yrs of first myocardial infarction

FOR INVESTORS ONLY


Door-to-Balloon Mortality decreasing

with Heart Failure increasing

Ezekowitz JA et al JACC 2009

STEMI POPULATION IMPACTING HEART FAILURE

Assuming future FDA approvals for use of Impella in additional indications

10%

76% 39%

14%

Large Infarcts Lead to Remodeling

and Development of Heart Failure

FOR INVESTORS ONLY

227

28

• 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

• Expected to initiate in the first half of calendar

2017 and complete within 18 months

• STEMI patient represents a potential new

patient indication (200k / year) that may benefit

from Impella unloading the left ventricle

STEMI FEASIBILITY STUDY APPROVED

FOR INVESTORS ONLY


CONCLUSION: ABIOMED IS COMMITTED TO IMPROVING

OUTCOMES IN PROTECTED PCI AND CARDIOGENIC SHOCK

• Protected PCI addresses an unmet need for an undertreated population

• Cardiogenic Shock caries one of the highest mortality rates in the

hospital and heart recovery remains the best option

• Abiomed’s IQ Program allows for collaboration with hospitals on

training, education and protocol development designed to improve

outcomes for Protected PCI and cardiogenic shock

• Unloading therapy may represent a revolutionary approach to reduce

the number of future heart failure patients after STEMI

FOR INVESTORS ONLY

29

30

TCT 2016 TAKEAWAYS:



AMI Cardiogenic Shock Partnership: 6% Penetration of 100k potential U.S. patients









DR. THORSTEN SIESS, ABIOMED CHIEF TECHNOLOGY OFFICER

NEW INDICATION & PIPELINE UPDATE



ABIOMED: THORSTEN SIESS, PHD

Dr. Thorsten Siess joined Abiomed in 2005 upon its acquisition of Impella

CardioSystems, AG, which he co-founded in 1998 and has served as Manager of R&D,

then Chief Technology Officer. His work in the development and marketing of the Impella

2.5 and 5.0 in Europe led to their CE Mark approval. During his time at the University of

Aachen he developed the Impella technology which served as a platform for the entire

Impella product portfolio. The products, which allow early intervention through a pencil-

sized VAD, are now available in 70 centers in 11 countries. Prior to founding Impella, Dr.

Siess served as Scientist in the Biomedical Technology Team at Helmholtz-Institute of

Biomedicine at the University of Aachen in Germany. Dr. Siess received a Ph.D. degree

as well as his MASc in Mechanical Engineering from the Technical University of Aachen.Dr. Thorsten SiessChief Technology Officer

The Abiomed research team (~35 people), lead by Dr. Siess, has deep rooted knowledge in the field of

cardiovascular research and a track-record of innovation. The company and / or team invented or co-

invented: Hemopump, the artificial heart, iTET, diagonal pumps, Deltastream, the first pulsatile extracorporeal

pump for ECMO, a-Med, Impella, Circulite, Symphony, expandable pump technologies (ECP), and patented

the first implantable centrifugal pumps.

FOR INVESTORS ONLY – DISCUSSION OF DEVICES IN DEVELOPMENT

32


IMPROVEMENTS IN EASE OF USE AND SUPPORT

• Quick console set-up time

• Higher flow percutaneous pump

• Impella RP (right-side support device)

• Axillary Implant / Ambulation for Patients

• Optical Sensor

• Simulator training tools and support

• Remote link services and 24x7 support line

FOR INVESTORS ONLY

33


34

15 “cannula” patents (expiring 2017 to

2031)

6 pending applications

4 “pigtail” patents (expiring 2023 to 2031)

2 pending application

5 “guidewire” patent (expiring 2031)


31 “motor” patents (expiring 2017 to

2028)


14 pressure sensor patents (expiring

2017 to 2021)


30 “pump design” patents (expiring 2017

to 2035)


Other Impella patents

22 patents (expiring 2017 to 2033)


ECP IP Portfolio (Acquisition 2014):

67 patents (expiring 2019 to 2035)


Abiomed Patent Summary Worldwide

254 total patents

188 Impella, 66 non-Impella, (expiring

2016-2035)


170 Impella, 50 non-Impella

INTELLECTUAL PROPERTY: 254 PATENTS, 220 PENDING



• Quicker set-up

• Improved placement and accuracy

• Advanced real-time patient management and

weaning protocols

SMART PUMPING: INTEGRATED OPTICAL PRESSURE SENSOR

Optical

Sensor

Placement

Signal


35


IMPELLA® ECP: EXPANDABLE CARDIAC POWER

• Smallest percutaneous heart pump:

~9F pump / catheter. Expands to ~20F

• Designed for flow >3.5 liters per minute

• Simple insertion / explant: Advances into

left ventricle over pigtail

• Smooth clear polyurethane membrane

sits across the aortic valve

• Ideal for Protected PCI indication

• First in Man planned CY 2H 2017


Inflow

Outflow

36


IMPELLA® ECP: INSERTION


337


CHRONIC CARE

BRIDGE TO HEART RECOVERY AND/OR HEART REMODELING


LIMITATIONS OF CURRENT HEART FAILURE (LVADS)

IMPLANTABLE DEVICES

• Surgical sternotomy procedures

• Long hospitalizations, high costs, and

frequent readmissions

• LVADs core the myocardium for implantation.

Not designed for heart recovery and makes

heart transplants more difficult

• Risk profile too high for Class III patients

(stroke, bleeding, infection, etc.)

• Limited heart transplant availability

ICU


39


A NEW APPROACH TO IMPLANTATION AND AMBULATION

Axillary Insertion of the Impella (5.0):

• Minimally Invasive ; No Sternotomy

• 90% of Impella 5.0 procedures are

currently completed via axillary

insertion (>2,000 patients)

• Maximum duration of support, to date:

107 days with Impella 5.0*

* Product labeling allows for the clinical decision to leave Impella 2.5, Impella CP, Impella 5.0 and Impella LD in place beyond the intended duration of four to six days due to unforeseen circumstances.


40


ABIOMED’S DESIGN FOR IMPELLA 5.0 / 5.5 / BTR:

DESIGNED FOR RECOVERY OR REMODELING

Designed to significantly improve

patient hemodynamics

Simple insertion via axillary

(no sternotomy/thoracotomy)

Simple device design, lower cost

Improves patient QOL and

allows for ambulation

Promotes native heart recovery

or remodeling


41


42

PATIENT MOBILIZATION: HELPS OUTCOMES & QUALITY OF LIFE

Video of Impella 5.0 German Patient with Axillary Insertion:



THE IMPELLA® 5.5: NEXT GENERATION IMPELLA® 5.0

Optical Sensor &

Cable

Monolithic motor housing

Rear sleeve bearing

with soldering PCBfront sleeve and

axial thrust

bearing

• ~9F catheter / ~19F pump

• Estimated Flow: 5.5 Liters / Minute

• Designed for duration of weeks – months

• Percutaneous / axillary / transcaval

insertion and explant

• First in man estimated: CY 2H 2017

• Requires PMA


43


IMPELLA® 5.5 CADAVER AXILLARY IMPLANT


44


IMPELLA® BTR: “BRIDGE TO RECOVERY”

• No sternotomy required, axillary insertion/implant

• Designed as longer term (up to 1 year) with

discharge wearable driver

• Size Design: ~9F catheter and ~19F pump

• Estimated flow ≥ 5.5 Liters / Minute

• Stage: Feasibility in Animals without anticoagulation

• Requires PMA

Wearable Driver


45


CONCLUSION: THE ENGINEERING OF HEART RECOVERY

• Abiomed invented percutaneous heart pumps and has strong IP

• Abiomed continues to improve Ease-of-Use in cath lab and ICU

• Smart pumping and smaller, higher flow pumps will impact heart

recovery outcomes

• Chronic heart failure patients (Class III) need less invasive, axillary

implant and higher flow to remodel the left ventricle

FOR INVESTORS ONLY

46


CLOSING REMARKS

MICHAEL R. MINOGUE, ABIOMED CHIEF EXECUTIVE OFFICER, PRESIDENT & CHAIRMAN



ELECTRICITY

PERCUTANEOUS, PMA-APPROVED TECHNOLOGIES

Stents/PCI2 Pacemaker / ICDs Edwards TAVR Impella®

CY 2015 Units/Patients per

year in U.S.1> 1 Million ~400,000 ~19,000 ~10,000

1. ACC/AHA 2015 Heart Disease and Stroke Statistics—2015 Update & Respective company websites and Leerink and William Blair analyst models

2. Percutaneous Coronary Intervention.

PUMPPLUMBING VALVE

48

FOR INVESTORS ONLY

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://www.jacksonheart.com/tavr.htm&ei=MVOsVNnjI-fbsASQ4IH4CQ&bvm=bv.83134100,d.cWc&psig=AFQjCNEL6OtPoGoAKshFTyDbHV3eVQKWgQ&ust=1420666029864812

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://www.jacksonheart.com/tavr.htm&ei=MVOsVNnjI-fbsASQ4IH4CQ&bvm=bv.83134100,d.cWc&psig=AFQjCNEL6OtPoGoAKshFTyDbHV3eVQKWgQ&ust=1420666029864812


49

IMPELLA® HEART PUMP: A BREAKTHROUGH TECHNOLOGY

• FDA Approvals: “Safe & Effective” for

High Risk PCI and Cardiogenic Shock;

HDE Impella RP®* for 5 Impella pumps

• CMS: DRG 215 Implant ; 268 ICU/Explant

• 1,100 U.S. hospitals ; 45,000+ patients

• 7 Clinical Guidelines ; >380 publications

• CE Mark (2002) ; Japanese PMDA (2016)

• 254 patents & 220 patents pending

FOR INVESTORS ONLY

* High Risk PCI PMA Approval for Impella 2.5; Cardiogenic Shock PMA Approval for Impella, 2.5, CP, 5.0, LD ; HDE for Impella RP


Reduces Mortality*:

• “Use of short-term MCS in

the United States has

increased rapidly, whereas

rates of in-hospital mortality

have decreased” 6

• “Hemodynamic support

demonstrates significantly

reduced mortality with

PVADs when compared to

IABP in patients undergoing

PCI”18

IMPELLA® HEART PUMPS ALIGN WITH HEALTHCARE REFORM

1. O’Neill et al, Circulation. PROTECT II, 2012

2. Maini et al, Journal of American College of Cardiology (abstract). USPella, 2013

3. Burzotta et al J Card Med, 2008

4. Dixon et al. Journal of American College of Cardiology Interv. PROTECT I, 2009

5. Sjauw et al. Journal of American College of Cardiology. MACH 2, 2009

6. Stretch et al, Journal of the American College of Cardiology, 2014

7. Lemaire et al, Annals of Thoracic Surgery, 2013

8. O’Neill et al, Journal of American College of Cardiology. USPella, 2013

9. Maini et al,Journal of Catheterization and Cardiovascular Interventions, 2014

10. Maini et al, Expert Review Pharmaeconomics & Outcomes Research, 2014

11. Roos et al, Journal of Medical Economics, 2013

12. Gregory et al, American Health & Drug Benefits Journal, 2013

13. Gregory et al, Journal of Managed Care Medicine, 2013

14. Krenn et al, SCAI, 2014

15. Aryana et al, Heart Rhythm Society, 2014

16. Wohns et al. International Society for Minimally Invasive Cardiothoracic Surgery, 2014

17. Lamarche et al. Journal of Thoracic and Cardiovascular Surgery, 2010

18. Patel et al. Journal of Interventional Cardiology, 2015

50

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

Is Cost-Effective:

• “Declining hospital costs”

(Cost Reduction $45k and $54k

per case in AMI and CAD) 6

• Reduces hospital length of stay 8,9,11,12,13,14,15,16,17

• Reduces expensive hospital

readmission costs11

• Creates minimal impact on

payer’s budget 12

FOR INVESTORS ONLY


ABIOMED AND U.S. HOSPITAL NETWORK COLLABORATING TO

IMPROVE EDUCATION, TRAINING AND CLINICAL OUTCOMES

Specialized

Protected PCI &

Heart Recovery

Hospital

Community

Hospital

Community

Hospital

Community

Hospital

• 400+ Specialized Protected PCI &

Heart Recovery Hospitals

• 1,100 of 1,400 Heart Hospitals* and

Cath Lab Hospitals trained to Implant

Impella for Cardiogenic Shock

• CMS DRG: 215 (implant) / 268 (ICU

care & explant)

• Dedicated resources at hospital to

advance patient care with Abiomed IQ

Program (>250 Abiomed field team

members ; 24x7 Call Center)

* 95% penetrated in heart hospitals (cath labs / surgical suites) ; 55% in cath lab only hospitals

Protocol:

FOR INVESTORS ONLY

51


FY’16

1. GAAP net income for fiscal year 2015 was $113.7 million included an income tax benefit of the $86.5million. This was a result of the Q4’FY15 release of the valuation allowance of most deferred tax assets. The release of the

valuation allowance was a onetime accounting adjustment with the offset recorded on the balance sheet as short and long term deferred tax assets based on the Company's estimates of sustainable profitability.

2. Cash, cash equivalents, short and long term marketable securities

GAAP Operating Income ($M)1 Debt: $0

Deferred Tax Asset1: $45 Million

($25)

$2

($11)

$8

$17

FY’12 FY’11 FY’13 FY’14

$60$77

$88

$118

$146

Cash ($M)2

POSITIVE CASH FLOW & STRONG BALANCE SHEET

$29

52

FY’10

FY’12

FY’11

FY’13 FY’14 FY’15

FY’15

$213

FY’16

$66

$237

Q2’17

FOR INVESTORS ONLY


Japan

Impella

5.0TM

Impella

CP®

53

Future

Protected PCITM

Impella ECPTM

Today / 2016

Products

Indications

Geographies

Cardiogenic

Shock

Impella

RP® HDE

Rest of World

STEMI

(Infarct

Reduction)

Impella 5.5TM

* Impella® ECP, Impella® 5.5, Impella® BTR, are in development and are not approved for use or sale

Germany

Right-Side &

Left Side

Support

Additional

Indications

(2017/2018)

U.S.

IMPELLA® PLATFORM: A LONG RUN-WAY FOR GROWTH

Heart Failure

(Class III)

Impella

2.5TM

250K U.S.

Patients100K U.S.

Patients

50K Patients20K Patients221K Patients

Impella BTRTM

Wearable

Driver

FOR INVESTORS ONLY


PIPELINE PRODUCT DEMO


THANK YOU

a tct investor breakfast: 2016abiomed-private.s3.amazonaws.com/assets/files/148293668764629… ·...

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