-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, OwyetTD0NpPcKyHmBob6+p9sQdKG+kFNVNbXDkcwXMy5z/XFkeyl+vxq+oFBhXAJ gtcEGwSeDvMizrHKTJI0rQ== 0001104659-04-031806.txt : 20041026 0001104659-04-031806.hdr.sgml : 20041026 20041026072644 ACCESSION NUMBER: 0001104659-04-031806 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20041026 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041026 DATE AS OF CHANGE: 20041026 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: 041095353 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 a04-12054_18k.htm 8-K

 

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:  October 26, 2004

(Date of earliest event reported)

 

ABIOMED, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

04-2743260

(State or other Jurisdiction of
Incorporation)

(IRS Employer Identification
Number)

 

 

0-20584

(Commission File Number)

 

 

22 Cherry Hill Drive
Danvers, MA 01923

(Address of Principal Executive Offices, including Zip Code)

 

 

(978) 777-5410

(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:

 

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

 

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

 

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

 

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

 

 



 

Item 2.02         Results of Operations and Financial Condition.

 

On October 26, 2004, we issued a press release reporting preliminary limited financial information, including the Company’s achievement of net profit, for the quarter ending September 30, 2004.  The full text of the Company’s press release is attached as Exhibit 99.01 to this report 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 9.01         Financial Statements and Exhibits

 

(c) Exhibits

 

 

 

99.01

Press release dated October 26, 2004

 

2



 

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/ Charles B. Haaser

 

 

 

 

 

Charles B. Haaser

 

 

 

 

 

Controller

 

 

 

 

 

Principal Accounting Officer

 

 

 

 

 

Principal Financial Officer

 

 

 

 

 

 

 

 

 

 

 

 

 

Date: October 26, 2004

 

 

 

 

 

 

3



 

Exhibit Index

 

Exhibit Number

 

Description

 

 

 

 

 

99.01

 

Press release dated October 26, 2004

 

 

4


EX-99.01 2 a04-12054_1ex99d01.htm EX-99.01

Exhibit 99.1

 

 

Media Contact:

Andrea tenBroek

Communications Specialist

(978) 646-1815

mediarelations@abiomed.com

 

Investor Relations:

Mark Vincent

Vice President

Euro RSCG Life NRP

(212) 845-4239

Mark.Vincent@eurorscg.com

 

ABIOMED Achieves Profitability in Second Quarter

 

96% Product Revenue Growth Driven By AB5000 Bridge to Recovery Platform

 

ABIOMED to issue full earning release and host conference call
on Monday, November 1st at 11:00 a.m. Eastern Time

 

DANVERS, Mass. (October 26, 2004) – ABIOMED, Inc. (NASDAQ: ABMD) today released highlights of its financial results for the second quarter of fiscal year 2005 ended September 30, 2004.  ABIOMED reported a net profit of $0.5 million on $10.4 million in product revenues, or $0.02 per share, as compared to a net loss of $2.8 million or $0.13 per share for the second quarter in fiscal year 2004.  The Company’s higher product revenues were driven by sales of ABIOMED’s AB5000 platform with 129% growth versus the prior quarter.  In combination with the steady growth of BVS 5000 sales, the Company achieved the first profitable quarter in the past eight fiscal years and the first profitable quarter based on product revenues in company history.

 

“ABIOMED has achieved profitability based upon product sales and has now set a goal for the Company to achieve full-year profitability from ongoing business operations.  We attribute this milestone to the rapid acceptance of our AB5000 heart assist device by surgeons, addressing a tremendous need for a reliable device to help patients whose hearts might recover if given adequate time.

 

Our team is pleased with our momentum, but clearly recognize that we have realized only a fraction of the overall potential for our products.  We remain committed to making this technology available globally, and working with surgeons to develop practices that help ensure the best possible outcomes for their patients,” stated Michael R. Minogue, CEO and President of ABIOMED.

 



 

The potential US caseload for Bridge to Recovery patients, those who suffer from an acute cardiac event and whose hearts have the potential to recover if given support, is 60,000 patients per year.(1)  Currently, less than 1,000 patients per year actually receive temporary support from a ventricular assist device with the goal of recovery, even though the alternative is usually death.  The survival rate for patients implanted with the BVS 5000 and AB5000 systems is greater than 50% at the top 20% of centers in ABIOMED’s installed base.(2)

 

ABIOMED will be issuing its full financial release and hosting a conference call to discuss fiscal 2005 second quarter results on  Monday, November 1st at 11:00 a.m. Eastern Time.  This call may be heard live via our web site at www.abiomed.com.

 

About ABIOMED

Based in Danvers, Massachusetts, ABIOMED, Inc. (pronounced “AB’-EE-O-MED”) is a leading developer, manufacturer and marketer of medical products designed to assist or replace the pumping function of the failing heart. ABIOMED, which currently sells the BVS® 5000 Biventricular Support System and the AB5000™ Circulatory Support System, is the market leader in devices for the temporary support of patients with failing but potentially recoverable hearts. In September 2004, ABIOMED applied for initial FDA market approval for the AbioCor® Implantable Replacement Heart to treat a defined subset of irreversible end-stage heart failure patients under a Humanitarian Device Exemption.

 

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. 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, anticipated future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, 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 Annual Report filed on Form 10-K.  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.

 

###

 


(1) Health Research International: U.S. Opportunities  in Heart Failure Technologies, March 2004

(2) ABIOMED data registry, 1993-present

 


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