0001564590-19-015033.txt : 20190502 0001564590-19-015033.hdr.sgml : 20190502 20190502071450 ACCESSION NUMBER: 0001564590-19-015033 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 20190502 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20190502 DATE AS OF CHANGE: 20190502 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ABIOMED INC CENTRAL INDEX KEY: 0000815094 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 042743260 STATE OF INCORPORATION: DE FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-09585 FILM NUMBER: 19789700 BUSINESS ADDRESS: STREET 1: 22 CHERRY HILL DR CITY: DANVERS STATE: MA ZIP: 01923 BUSINESS PHONE: 9787775410 MAIL ADDRESS: STREET 1: 22 CHERRY HILL DRIVE CITY: DANVERS STATE: MA ZIP: 01923 8-K 1 abmd-8k_20190502.htm 8-K abmd-8k_20190502.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 2, 2019

 

ABIOMED, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-09585

04-2743260

(State or Other Jurisdiction

of Incorporation)

(Commission
File Number)

(IRS Employer

Identification No.)

22 Cherry Hill Drive
Danvers, MA 01923

(Address of Principal Executive Offices, including Zip Code)

(978) 646-1400

(Registrant’s Telephone Number, including Area Code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.   

 

Securities registered pursuant to Section 12(b) of the Act

Ticker symbol

Name of each exchange on which registered

Common Stock, $.01 par value

ABMD

The NASDAQ Stock Market LLC

 

 

 

 

 

 

 


 

Item 2.02   Results of Operations and Financial Condition.

On May 2, 2019, we issued a press release reporting our financial results for our fourth quarter ended March 31, 2019.  A copy of the press release is set forth as Exhibit 99.1 and is incorporated herein by reference. The information contained in this report shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Securities Act of 1934, whether made before or after the date hereof and regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such filing.

Item 8.01   Other Events.

On May 2, 2019, we issued a press release announcing that the FDA approved protocol for ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) pivotal randomized controlled trial. A copy of the press release is set forth as Exhibit 99.2 and is incorporated herein by reference.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

 

 

 

 

Exhibit

  

Description

99.1

99.2

  

Q4 FY2019 earnings press release dated May 2, 2019.

STEMI DTU press release dated May 2, 2019.

 

 



Exhibit Index

 

 

 

 

Exhibit Number

  

Description

99.1

  

Q4 FY2019 earnings press release dated May 2, 2019.

99.2

  

STEMI DTU press release dated May 2, 2019.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

 

 

 

 

 

 

 

 

 

Abiomed, Inc.

 

 

 

 

 

 

 

 

By:

 

/s/ Todd A. Trapp

 

 

 

 

 

 

Todd A. Trapp

Vice President, Chief Financial Officer

(Principal Financial and Accounting Officer)

Date: May 2, 2019

 

 

 

 

 

 

 

 

 

EX-99.1 2 abmd-ex991_6.htm EX-99.1 abmd-ex991_6.htm

Exhibit 99.1

 

ABIOMED ANNOUNCED Q4 FY 2019 REVENUE OF $207 MILLION AND 31.6% OPERATING MARGIN

 

FY 2019 Annual Revenue of $769 Million, Up 30%, and 29.2% Operating Margin

 

DANVERS, Mass. — May 2, 2019Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart recovery and support technologies, today reported fourth quarter fiscal 2019 revenue of $207.1 million, an increase of 19% compared to revenue of $174.4 million for the same period of fiscal 2018. For fiscal year 2019, total revenue was $769.4 million, up 30% compared to revenue of $593.7 million, and operating income was $224.8 million, up 43% compared to operating income of $157.1 million in fiscal year 2018.

 

“Q4 did not meet our expectations. I take full responsibility for our disappointing performance given a soft March, and we have already initiated a plan of action to correct the course. However, Abiomed had a solid year with 30% growth and improvement in margins. Most importantly, Abiomed’s clinical support, training, and education helped improve patient outcomes in both high-risk PCI and cardiogenic shock. Multiple publications continue to validate the benefits of Impella supported PCI and Impella best practices to help improve survival in cardiogenic shock,” said Abiomed Chairman, President and CEO, Michael R. Minogue. “I am confident in our innovation and business today as well as long-term outlook for Abiomed.  We are creating the new Field of Heart Recovery.”

 

Recent financial and operating highlights include:

 

Worldwide Impella® heart pump revenue for the quarter totaled $199.5 million, an increase of 19% compared to revenue of $168.3 million during the same period of the prior fiscal year. Full year worldwide Impella heart pump revenue totaled $741.7 million for fiscal 2019, an increase of 30% compared to revenue of $570.9 million for the prior fiscal year.

 

U.S. Impella product revenue for the quarter totaled $169.7 million, an increase of 16% compared to revenue of $146.2 million during the same period of the prior fiscal year with U.S. patient usage of the Impella heart pumps up 14%, driven by lower growth in March. Full year U.S. Impella revenue totaled $639.3 million, up 27% compared to $505.1 million in the prior fiscal year with U.S. patient usage of the Impella heart pumps up 23%.

 

Outside the U.S., Impella product revenue for the quarter totaled $29.8 million, an increase of 35% compared to revenue of $22.1 million during the same period of the prior fiscal year. Full year Impella product revenue outside the U.S. totaled $102.4 million, an increase of 56% compared to $65.7 million in the prior fiscal year. Specifically, Japan revenue was $5.4 million for the quarter and $17.5 million for the year, up 212% and 503%, respectively, compared to prior fiscal year.

 

Gross margin for the fourth quarter of fiscal 2019 was 83.2% compared to 82.7% during the same period of fiscal 2018. For the full fiscal year 2019, gross margin was 83.2% compared to 83.4% in fiscal year 2018.

 

Operating income for the fourth quarter fiscal 2019 was $65.4 million, or 31.6% operating margin, compared to $47.6 million, or 27.3% operating margin in the same period of fiscal 2018. For the full fiscal year 2019, operating income was $224.8 million, or 29.2% of revenue, compared to $157.1 million, or 26.5% of revenue in the prior fiscal year.

 

Fourth quarter fiscal 2019 GAAP net income was $74.0 million, or $1.60 per diluted share, an increase of 101%, compared to GAAP net income of $36.8 million or $0.80 per diluted share for the prior fiscal year. Full fiscal year 2019 GAAP net income was $259.0 million, or $5.61 per diluted share, an increase of 131%, compared to $112.2 million, or $2.45 per diluted share for the prior fiscal year. Fourth quarter and full year fiscal GAAP net income includes a $23.6 million, or $0.51 per diluted share unrealized gain on our investment in Shockwave


Medical, Inc.

 

The company generated operating cash flow of $72.2 million in the fourth quarter and $254.0 million for the full fiscal year 2019. During fiscal 2019, the company deployed $71.8 million of cash to repurchase shares related to vested equity awards and $42.7 million for strategic investments in medical device technologies, including Shockwave Medical, Inc. As of March 31, 2019, the company had $513.4 million of cash and marketable securities and no debt.

 

On January 31, the company earned CE Mark for Impella Connect, the first-of-its kind cloud-based technology that enables secure, real-time, remote monitoring of patients on the Impella console for Abiomed clinical consultants and physicians from anywhere with internet connectivity.

 

On February 4, the FDA released a letter to health care providers on the Impella RP heart pump. On March 18, the company presented and published survival data from the 18-month post-approval study of 42 Impella RP patients at the American College of Cardiology’s (ACC) 68th Annual Scientific Session in New Orleans and submitted the post-approval study report to the FDA. The FDA recognizes salvage patients as those outside the Recover Right protocol (>48 hours in cardiogenic shock).   

 

On March 25, the company received Pharmaceuticals and Medical Devices Agency (PMDA) approval from the Japanese Ministry of Health, Labour & Welfare for the Impella CP® heart pump.

 

On April 4, the company announced that cardiogenic shock survival rates have improved significantly in the three years since the Impella FDA PMA Approval. New data from the IQ Database on patients treated between April 2018 and March 2019 showed an increase in median survival from 51% to 67%, a relative increase of 34% in survival.  Additionally, results published by Dr. Tehrani at Inova Heart and Vascular Institute in the Journal of the American College of Cardiology demonstrate that best practice protocols with early use of percutaneous mechanical circulatory support in AMI cardiogenic shock increased survival at 30 days from 44% to 82% (p=0.0001).

 

On April 23, the company highlighted clinical data on its exclusive FDA approval for high-risk PCI and on the advantages of Protected PCI to enable complete revascularization and improved patient quality of life.  A new study was published in the Journal of Interventional Cardiology by Dr. Burzotta and found that six months after a Protected PCI, the number of patients with left ventricular ejection fraction (LVEF) greater than or equal to 35% increased from 22% to 67%.

 

Today, the company announced in a separate press release that the FDA approved the initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) pivotal randomized controlled trial.

 

FISCAL YEAR 2020 OUTLOOK

 

The company is giving its fiscal year 2020 guidance for total revenues to be in the range of $900 million to $945 million, an increase of 17% to 23% over the prior year. The company is also giving its fiscal year 2020 guidance for GAAP operating margin to be in the range of 29% to 31%.  The company plans to give another formal forecast for the fiscal year on our next earnings call.

 

EARNINGS CONFERENCE CALL DETAILS

 

The company will host a conference call to discuss the results at 8 a.m. EST on Thursday, May 2, 2019. The conference call releasing full quarterly results will be hosted by Michael R. Minogue, Chairman, President and Chief Executive Officer and Todd A. Trapp, Vice President and Chief Financial Officer.

To listen to the call live, please tune into the webcast via https://edge.media-server.com/m6/p/sg8hmgr6 or dial (855) 212-2361; the international number is (678) 809-1538. A replay of this conference call will be available beginning at 12:00 p.m. EST May 2, 2019 through 12:00 p.m. EST on May 9, 2019. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 2498807.

 

ABOUT ABIOMED

Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory


support.  Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com. To learn more about the Impella platform of heart pumps, including their approved indications and important safety and risk information associated with the use of the devices, please visit: www.protectedpci.com.

 

The Abiomed logo, Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, Impella Connect, and Recovering hearts. Saving lives. are registered trademarks of Abiomed, Inc. in the U.S. and in certain foreign countries.

 

FORWARD-LOOKING STATEMENTS

This release 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 and expected regulatory approvals. The company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the unpredictability of future operating results, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, 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 release. 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 release or to reflect the occurrence of unanticipated events.

 

For further information please contact:  

 

Ingrid Goldberg

Tom Langford

Director, Investor Relations

Director, Communications & Public Relations

978-646-1590

978-882-8408

ir@abiomed.com

tlangford@abiomed.com

 

 


Abiomed, Inc. and Subsidiaries

 

Consolidated Balance Sheets

 

(Unaudited)

 

(in thousands, except share data)

 

 

 

 

 

 

 

 

 

 

 

 

March 31, 2019

 

 

March 31, 2018

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

121,021

 

 

$

42,975

 

Short-term marketable securities

 

 

370,677

 

 

 

319,274

 

Accounts receivable, net

 

 

90,809

 

 

 

70,010

 

Inventories

 

 

80,942

 

 

 

50,204

 

Prepaid expenses and other current assets

 

 

13,748

 

 

 

11,808

 

Total current assets

 

 

677,197

 

 

 

494,271

 

Long-term marketable securities

 

 

21,718

 

 

 

37,502

 

Property and equipment, net

 

 

145,005

 

 

 

117,167

 

Goodwill

 

 

32,601

 

 

 

35,808

 

In-process research and development

 

 

15,208

 

 

 

16,705

 

Long-term deferred tax assets, net

 

 

77,502

 

 

 

70,746

 

Other assets

 

 

85,115

 

 

 

14,176

 

Total assets

 

$

1,054,346

 

 

$

786,375

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

32,185

 

 

$

23,565

 

Accrued expenses and other liabilities

 

 

57,420

 

 

 

46,147

 

Deferred revenue

 

 

16,393

 

 

 

14,970

 

Total current liabilities

 

 

105,998

 

 

 

84,682

 

Other long-term liabilities

 

 

1,061

 

 

 

776

 

Contingent consideration

 

 

9,575

 

 

 

10,490

 

Long-term deferred tax liabilities

 

 

822

 

 

 

903

 

Total liabilities

 

 

117,456

 

 

 

96,851

 

 

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Class B Preferred Stock, $.01 par value

 

 

 

 

 

 

Authorized - 1,000,000 shares; Issued and outstanding - none

 

 

 

 

 

 

 

 

Common stock, $.01 par value

 

 

451

 

 

 

444

 

Authorized - 100,000,000 shares; Issued - 47,026,226 shares at March 31, 2019 and 46,100,649 shares at March 31, 2018;

 

 

 

 

 

 

 

 

Outstanding - 45,122,985 shares at March 31, 2019 and 44,375,337 shares at March 31, 2018

 

 

 

 

 

 

 

 

Additional paid in capital

 

 

690,507

 

 

 

619,905

 

Retained earnings (Accumulated deficit)

 

 

399,473

 

 

 

140,457

 

Treasury stock at cost - 1,903,241 shares at March 31, 2019 and 1,725,312 shares at March 31, 2018

 

 

(138,852

)

 

 

(67,078

)

Accumulated other comprehensive income (loss)

 

 

(14,689

)

 

 

(4,204

)

Total stockholders' equity

 

 

936,890

 

 

 

689,524

 

Total liabilities and stockholders' equity

 

$

1,054,346

 

 

$

786,375

 

 

 

 

 

 

 

 


Abiomed, Inc. and Subsidiaries

 

Consolidated Statements of Operations

 

(Unaudited)

 

(in thousands, except per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

March 31,

 

 

Fiscal Years Ended

March 31,

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Revenue

$

 

207,081

 

 

$

 

174,436

 

 

$

 

769,432

 

 

$

 

593,749

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

 

34,848

 

 

 

 

30,098

 

 

 

 

129,567

 

 

 

 

98,581

 

Research and development

 

 

25,548

 

 

 

 

21,270

 

 

 

 

93,503

 

 

 

 

75,297

 

Selling, general and administrative

 

 

81,296

 

 

 

 

75,501

 

 

 

 

321,550

 

 

 

 

262,734

 

 

 

 

141,692

 

 

 

 

126,869

 

 

 

 

544,620

 

 

 

 

436,612

 

Income from operations

 

 

65,389

 

 

 

 

47,567

 

 

 

 

224,812

 

 

 

 

157,137

 

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Investment income, net

 

 

2,769

 

 

 

 

1,303

 

 

 

 

8,166

 

 

 

 

3,688

 

Other income (expense), net

 

 

30,372

 

 

 

 

(363

)

 

 

 

30,382

 

 

 

 

(388

)

 

 

 

33,141

 

 

 

 

940

 

 

 

 

38,548

 

 

 

 

3,300

 

Income before income taxes

 

 

98,530

 

 

 

 

48,507

 

 

 

 

263,360

 

 

 

 

160,437

 

Income tax provision

 

 

24,569

 

 

 

 

11,660

 

 

 

 

4,344

 

 

 

 

48,267

 

Net income (A)

$

 

73,961

 

 

$

 

36,847

 

 

$

 

259,016

 

 

$

 

112,170

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic net income per share

$

 

1.64

 

 

$

 

0.83

 

 

$

 

5.77

 

 

$

 

2.54

 

Basic weighted average shares outstanding

 

 

45,091

 

 

 

 

44,320

 

 

 

 

44,911

 

 

 

 

44,153

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted net income per share (B)

$

 

1.60

 

 

$

 

0.80

 

 

$

 

5.61

 

 

$

 

2.45

 

Diluted weighted average shares outstanding

 

 

46,173

 

 

 

 

46,141

 

 

 

 

46,151

 

 

 

 

45,849

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(A) Net income includes the effect of the following items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Effect of the Tax Reform Act on net deferred tax assets (1)

$

 

 

 

$

 

(593

)

 

$

 

 

 

$

 

21,364

 

Excess tax benefits related to stock-based compensation awards (2)

 

 

(798

)

 

 

 

(6,501

)

 

 

 

(69,267

)

 

 

 

(30,991

)

Unrealized gain on investment in Shockwave Medical - net of tax (3)

 

 

(23,636

)

 

 

 

 

 

 

 

(23,636

)

 

 

 

 

 

$

 

(24,434

)

 

$

 

(7,094

)

 

$

 

(92,903

)

 

$

 

(9,627

)

(B) Diluted net income per share includes the effect of the following items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Effect of the Tax Reform Act on net deferred tax assets (1)

$

 

 

 

$

 

(0.01

)

 

$

 

 

 

$

 

0.47

 

Excess tax benefits related to stock-based compensation awards (2)

 

 

(0.02

)

 

 

 

(0.14

)

 

 

 

(1.50

)

 

 

 

(0.68

)

Unrealized gain on investment in Shockwave Medical - net of tax (3)

 

 

(0.51

)

 

 

 

 

 

 

 

(0.51

)

 

 

 

 

 

$

 

(0.53

)

 

$

 

(0.15

)

 

$

 

(2.01

)

 

$

 

(0.21

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


(1)  On December 22, 2017, the Tax Cut and Jobs Act was enacted into law, which among other items, reduced the U.S. federal statutory corporate income tax rate from 35% to 21% effective January 1, 2018. During the three months and year ended March 31, 2018, the company recorded tax expense adjustments related to the revaluation of its deferred taxes due to a reduction of the U.S. federal statutory corporate income tax rate.

 

(2) Amount represents the impact of excess tax benefits and shortfalls associated with stock-based awards in each respective period presented.

 

(3) In the fourth quarter of fiscal 2019, the company recorded an unrealized gain on its investment in Shockwave Medical of $31.2 million ($23.6 million, net of tax provision) and is recorded within other income (expense), net.

 

 

EX-99.2 3 abmd-ex992_315.htm EX-99.2 abmd-ex992_315.htm

Exhibit 99.2

 

 

 

FOR IMMEDIATE RELEASE

May 2, 2019

 

FDA Approves Initiation of STEMI DTU Pivotal
Randomized Controlled Trial

 

DANVERS, Mass., May 2, 2019 – Abiomed (NASDAQ: ABMD) announces that, on April 26, the FDA approved initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial. The prospective, multi-center, two-arm trial plans to enroll 668 patients undergoing treatment for a STEMI heart attack. Half the patients will be randomized to receive delayed reperfusion after 30 minutes of left ventricular unloading with the Impella CP. The other half will receive immediate reperfusion, the current standard of care.

The trial will test the hypothesis that unloading the left ventricle for 30 minutes prior to reperfusion will reduce myocardial damage from a heart attack and lead to a reduction in future heart failure related events. Myocardial damage can lead to an infarct, and every 5% increase in infarct size is associated with a 20% increase in relative hazard for all-cause mortality or hospitalization for heart failure within one year after a primary PCI1. Coronary artery disease is the number one cause of death in the United States. 47% of women and 36% of men over the age of 45 will die within 5 years of their first heart attack2.

“The STEMI DTU Pivotal Trial has the potential to improve the standard of care, slow the growing epidemic of heart failure and improve outcomes for millions of heart attack patients. This trial is the first
of its kind to focus on ventricular unloading as part of a therapeutic approach for heart attacks without cardiogenic shock and could lead to a paradigm shift in the way heart attack patients are treated worldwide,” said Navin Kapur, MD, the study’s co-principal investigator and the executive director of
the CardioVascular Center for Research and Innovation (CVCRI) at Tufts Medical Center.

 

Study Summary

Planned Enrollment:

 

668 subjects, enrolled at up to 60 sites

 

Additionally, the protocol requires each site to “roll-in” two patients (one in each arm) to test the study protocol before beginning enrollment. The trial allows for an adaptive design, which permits adjustments to the study sample size after an interim analysis.

Expected Timeline:

 

Enrollment begins in October 2019 and is expected to end in 3-4 years, 2022-2023

 

1 

Stone, et al., Relationship Between Infarct Size and Outcomes Following Primary PCI, JACC, 2016

 

2 

Heart Disease and Stroke Statistics 2019 Update: A Report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee." (Circulation. 2019;139(10):56–528).


 

6 months after enrollment completion: FDA submission for indication approval, based on primary endpoint and safety data analysis

Endpoints:

 

Primary Endpoint - Infarct size as a percent of left ventricular mass, measured at 3-5 days using cardiac MRI

 

Key Secondary Effectiveness Endpoint - A composite of the primary endpoint and the following:

 

o

Cardiogenic shock after 24 hours post enrollment out to 30 days

 

o

Cardiovascular mortality at 24 months

 

o

Heart failure requiring hospitalization at 24 months

 

o

Implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy (CRT) placement at 24 months

 

o

The trial is powered for multiple other secondary endpoints and has numerous exploratory endpoints, such as infarct size to area at risk

Projected Budget:

 

$25 million to complete enrollment with an additional two-year follow up to clinical secondary endpoints

Reimbursement:

 

Reimbursement for the Impella device is anticipated for patients in the study through CMS category B, as it was during the STEMI DTU safety and feasibility trial

A detailed protocol synopsis is available at this link.

The pivotal trial will build on the promising results of the successful STEMI DTU safety and feasibility trial, which met its goal by demonstrating it is safe and feasible to conduct a study of 30 minutes of unloading with delayed reperfusion. The accompanying chart compares the safety and feasibility trial results to the CRISP AMI trial’s standard of care arm (reperfusion only) and demonstrates how 30 minutes of unloading prior to reperfusion has the potential to reduce infarct size in STEMI.

“A successful study will transform the treatment of heart attacks and reduce heart failure for hundreds of thousands of patients each year. As a result, it is important to execute with the highest scientific rigor to ensure a successful study concludes with a Class I recommendation to reach 200,000 U.S. heart attack patients and more than 4 million patients outside the U.S.,” said Michael R. Minogue, Chairman, President and CEO of Abiomed.

The pivotal trial will be overseen by a steering committee of five expert cardiologists and clinical trialists. They are: Dr. Kapur, William O’Neill, MD, medical director of the Center for Structural Heart Disease at Henry Ford Hospital, Jeffrey Moses, MD, professor of medicine at Columbia University Medical Center and director of interventional cardiovascular therapeutics at Columbia University Medical Center, Gregg Stone, MD, professor of medicine at Columbia University College of Physicians and Surgeons and director of cardiovascular research and education at the Center for Interventional Vascular Therapy at New York-


Presbyterian Hospital/Columbia University Medical Center, and James Udelson, MD, chief of the division of cardiology at Tufts Medical Center.

The trial is sponsored by Abiomed. Impella heart pumps are not FDA approved for use in STEMI patients without cardiogenic shock.

 

ABOUT IMPELLA HEART PUMPS

The Impella 2.5 and Impella CP devices are FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. The Impella 2.5®, Impella CP®, Impella CP® with SmartAssist, Impella 5.0® and Impella LD® are FDA approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart. To learn more about the Impella platform of heart pumps, including their approved indications and important safety and risk information associated with the use of the devices, please visit: www.protectedpci.com.

Impella is the most studied mechanical circulatory support device in the history of the FDA and has exclusive PMA approvals for high-risk PCI, as a therapy to allow for native heart recovery after cardiogenic shock derived from AMI or cardiomyopathy, and right ventricular heart failure.

The Abiomed logo, Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, Impella Connect, and Recovering hearts. Saving lives. are registered trademarks of Abiomed, Inc. in the U.S. and in certain foreign countries.

ABOUT ABIOMED

Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com.

FORWARD-LOOKING STATEMENTS

This release 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 and expected regulatory approvals. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, 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 release. 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 release or to reflect the occurrence of unanticipated events.

**For further information please contact:

Tom Langford
Director, Communications and Public Relations
978-882-8408
tlangford@abiomed.com


Ingrid Goldberg Ward
Director, Investor Relations

978-646-1590

igoldberg@abiomed.com

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