-----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, QL17ySuH4ZTWZLbYH405NfJytTz4oI5eqHiWNaBgRNM3XM/32FITCmigBBgVyiFp K4XkZHDDiMTnyEnz1HmvgA== 0001104659-04-003146.txt : 20040210 0001104659-04-003146.hdr.sgml : 20040210 20040210085907 ACCESSION NUMBER: 0001104659-04-003146 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20040210 ITEM INFORMATION: ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040210 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: 04579613 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 a04-2043_28k.htm 8-K

 

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

 

February 10, 2004

(Date of earliest event reported)

 

ABIOMED, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

 

0-20584

 

04-2743260

(State or other jurisdiction
of incorporation)

 

(Commission File Number)

 

(IRS Employer
Identification No.)

 

 

 

22 Cherry Hill Drive, Danvers, Massachusetts

 

01923

(Address of principal executive offices)

 

(Zip Code)

 

 

 

(978) 777-5410

(Registrant’s telephone number, including area code)

 

 

 

 

 

Not Applicable

(Former name, former address and former fiscal year, if changed since last report)

 

 



 

Item 7.            Financial Statements and Exhibits.

 

(c) Exhibits

 

Exhibit Number

 

Description

99.1

 

Press release dated February 10, 2004

 

Item 12.         Results of Operations and Financial Condition.

 

On February 10, 2004, ABIOMED, Inc. announced its financial results for its third fiscal quarter ending December 31, 2003.  The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Form 8-K and the Exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Act”) 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 Exchange Act, except as expressly set forth by specific reference in such filing.

 

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:       February 10, 2004

 

3



 

Exhibit Index

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press release dated February 10, 2004

 

4


EX-99.1 3 a04-2043_2ex99d1.htm EX-99.1

Exhibit 99.1

 

 

Company Contact:

Andrea tenBroek
Communications Specialist
(978) 646-1419
mediarelations@abiomed.com

 

Investor Relations:

Edward E. Berger, Ph.D.
Vice President for Policy, Reimbursement and External Relations
(978) 646-1411
ir@abiomed.com

 

ABIOMED REPORTS THIRD FISCAL QUARTER FINANCIAL RESULTS

Product Revenues Increase 17%, Net Loss Reduced 56% From Prior Year

 

DANVERS, Mass. (February 10, 2004) – ABIOMED, Inc. (NASDAQ: ABMD) today released financial results for the third quarter of fiscal year 2004 ended December 31, 2003, and commented on significant highlights of the quarter.

 

Highlights of Financial Results of Operations for the quarter include:

                  Continued progress toward our goal of profitablity from existing business operations: net loss for the quarter reduced to $0.09 per share compared to $0.13 per share in the previous consecutive quarter and $0.21 per share in the same quarter of the prior year

                  Initial controlled commercial introduction of a new disposable blood pump for use with the AB5000™ Circulatory Support System

                  Product revenues for the quarter of $6.5 million, a 17% increase from the corresponding quarter in the prior year

                  Cash consumed by operating activities of $7.4 million, a 42% decrease over cash consumed by operations in the comparable quarter of the prior year

 



 

“Our fiscal third quarter showed steady progress toward our goal of profitability from our existing commercial operations.  Increased product revenues, combined with continued improvements to our operational efficiency have resulted in a third consecutive quarter of financial performance improvement," said chairman and chief executive officer Dr. David M. Lederman.

 

“During the quarter, we also added staff resources in a number of areas that are intended to make us more efficient and more responsive to our customers and to our markets,” Dr. Lederman added. “We have enhanced our capabilities in marketing, corporate communications and engineering. We believe these additions, and others to come, will make us a stronger company as we prepare for full commercial rollout of the AB5000 system.”

 

“We have identified important steps to further improve the performance of the AbioCor® and reduce the potential for adverse events such as stroke.  In addition, we are extremely pleased to have added Boston’s Beth Israel Deaconess Medical Center and its strong clinical team as an AbioCor clinical site, and look forward to their active participation in the trial,” commented Dr. Lederman.

 

Financial results for the third quarter of fiscal year 2004 ended December 31, 2003 are summarized in the attached table, and are detailed in ABIOMED’s Quarterly Report on Form 10-Q filed today with the Securities and Exchange Commission.   The following are some of the topics discussed in the company’s Form 10-Q filing:

 

The AbioCor Clinical Trial: As the initial AbioCor clinical trial enters its final phase, the company continues to plan for the initial commercial introduction of the AbioCor replacement heart through a Humanitarian Device Exemption by the end of calendar 2004.  While ABIOMED reported no new clinical trial implants during the quarter, the company disseminated its findings from a review of the AbioCor clinical experience to date to its clinical investigators and advisors in preparation for upcoming implants.

 

Product Revenues: Product revenues for the quarter were $6.5 million, a 17% increase over the comparable quarter of the prior year.  While BVS® 5000 blood pump reorders remain

 



 

the single largest component of the revenue stream, enthusiastic customer response to the new model AB5000 blood pump contributed to the quarter’s excellent result.  ABIOMED has been conducting a carefully controlled clinical introduction of the AB5000 console and blood pump, and expects to begin a full commercial rollout of the AB5000 system during the first quarter of the next fiscal year.

 

Progress toward profitability from existing commercial operations: The quarter ended December 31, 2003 showed continued strong progress toward profitable operations.  Net loss was narrowed in the quarter to approximately $2.0 million, or $0.09 per share, 56% below the net loss of approximately $4.4 million, or $0.21 per share, in the same period of the previous year.

 

ABIOMED will be hosting a conference call with analysts and investors to discuss fiscal 2004 third quarter results.  This conference call is scheduled for today, February 10, at 11:00 a.m. Eastern Time and may be heard live via our website at www.abiomed.com.

 

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. The company’s AbioCor® Implantable Replacement Heart is the subject of an initial clinical trial being conducted under an Investigational Device Exemption from the United States Food and Drug Administration.  The AbioCor has not been approved for commercial distribution, and is not available for use or sale outside of the initial clinical trial.

 

This Release contains forward-looking statements, including statements regarding development of ABIOMED’s existing and new products, the plans, timing and clinical results of the AbioCor trial, and the company’s progress toward commercial growth and profitability. 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.

 



 

FINANCIAL HIGHLIGHTS

 

CONSOLIDATED OPERATING RESULTS (Unaudited)

 

 

 

Three Months Ended

 

Nine Months Ended

 

(In thousands, except per share data)

 

Dec. 31
2003

 

Dec. 31
2002

 

Dec. 31
2003

 

Dec. 31
2002

 

 

 

 

 

 

 

 

 

 

 

Product Revenues

 

$

6,526

 

$

5,591

 

$

16,825

 

$

16,178

 

Funded Research & Development

 

157

 

29

 

299

 

324

 

Total Operating Revenues

 

6,683

 

5,620

 

17,124

 

16,502

 

 

 

 

 

 

 

 

 

 

 

Cost of Product Revenues

 

2,125

 

2,088

 

4,758

 

5,359

 

R&D Expenses

 

3,115

 

4,990

 

10,831

 

16,288

 

S,G&A Expenses

 

3,680

 

3,272

 

10,098

 

11,028

 

Total Operating Expenses

 

8,920

 

10,350

 

25,687

 

32,675

 

Loss from Operations

 

(2,237

)

(4,730

)

(8,563

)

(16,173

)

Interest and Other Income, Net

 

270

 

291

 

650

 

1,042

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

$

(1,967

)

$

(4,439

)

$

(7,913

)

$

(15,131

)

 

 

 

 

 

 

 

 

 

 

Net Loss per Share

 

$

(0.09

)

$

(0.21

)

$

(0.37

)

$

(0.72

)

 

 

 

 

 

 

 

 

 

 

Weighted Average Shares Outstanding

 

21,173

 

21,016

 

21,102

 

20,984

 

 

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

 

 

 

Dec. 31
2003

 

March 31
2003

 

 

 

 

 

 

 

Cash and Investments

 

$

47,447

 

$

54,449

 

Working Capital

 

$

31,870

 

$

57,336

 

Total Assets

 

$

58,831

 

$

68,337

 

Current Liabilities

 

$

3,983

 

$

6,247

 

Stockholders’ Equity

 

$

54,848

 

$

62,090

 

 


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