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ABIOMED Announces First Fiscal Quarter Results.


Business Editors & Health/Medical Writers

DANVERS, Mass.--(BW HealthWire)--July 26, 2001

ABIOMED, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: ABMD ABMD areal bone mineral density
ABMD AEGIS Ballistic Missile Defense (US Navy)
ABMD Advanced Ballistic Missile Defense
) today reported consolidated operating revenues operating revenue

Revenue from any regular source. Revenue from sales is adjusted for discounts and returns when calculating operating revenue. Compare other revenue.
 of $6.0 million for its fiscal quarter ended June 30, 2001. Product revenues for the quarter rose by 4% to $5.7 million compared to $5.5 million in the same period last year. Funded research and development revenues for the quarter declined to $0.2 million from $0.4 million in the previous year.

The Company also reported investment of $7.1 million in research and development activities during the quarter, an increase of $2.6 million compared with the prior year. The increase in research and development expenditures during the quarter is primarily related to preparations for initial clinical trials of the AbioCor(TM) Implantable Replacement Heart. Those clinical trials commenced on July 2, 2001.

The Company reported a net loss of approximately $6.3 million, or $0.30 per share, compared to a loss of $2.0 million, or $0.10 per share, in the first quarter of the previous fiscal year.

Commenting on the results of the fiscal quarter, Dr. David M. Lederman, Chief Executive Officer, said, "we continue to make progress with our BVS BVS Biblioteca Virtual em Saúde (Brazil)
BVS Bureau of Vital Statistics
BVS Brethren Volunteer Service (Church of the Brethren)
BVS Boston Vegetarian Society (Cambridge, MA) 
(R) business which, as a ventricular assist device ventricular assist device: see under heart, artificial. , is the market leader in "bridge to recovery". In particular, our new backup/transport console has been well received and combined with our Hub and Spoke Any architecture that uses a central connecting point. It is the same as a star topology in a network. A network hub is hardware that functions as a central hub to all nodes. See hub and full mesh.

 Program appears to be helping smaller medical centers more effectively manage their BVS patients. In addition, we ended the fiscal quarter ready to commence initial clinical trials with the AbioCor. It took tremendous efforts by many people to get to this stage. Thus far, we are very encouraged by the early performance of the AbioCor in the first patient. The device has performed as designed. We remain committed to a highly ethical study in which we will always place the patients' interests as the primary determinants of our decisions. Furthermore, we believe that if we focus on what is best for the patients we will increase the likelihood of early clinical trial success and, subject to regulatory approval, commercial success of the AbioCor."

The Company has scheduled a conference call with analysts and investors to discuss its operating results. The conference call is scheduled for 11:00 a.m. (EST EST electroshock therapy.

EST
abbr.
electroshock therapy
) today, July 26, 2001, and can be heard via the Company's web site at www.abiomed.com.

Based in Danvers, Massachusetts Danvers is a town in Essex County, Massachusetts, United States. Located on the Danvers River near the northeastern coast of Massachusetts, Danvers is most widely known for its association with the 1692 Salem witch trials. , 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. The Company's AbioCor Implantable Replacement Heart is being implanted im·plant  
v. im·plant·ed, im·plant·ing, im·plants

v.tr.
1. To set in firmly, as into the ground: implant fence posts.

2.
 in patients as part of an initial clinical trial conducted under an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and  from the U.S. Food and Drug Administration. The AbioCor, which is to extend and improve the lives of patients with irreversible irreversible (ir´ēvur´sebl),
adj incapable of being reversed or returned to the original state.
 end-stage heart failure End-stage heart failure
Severe heart disease that does not respond adequately to medical or surgical treatment.

Mentioned in: Heart Transplantation
, is not approved or available for use or sale outside of the initial clinical trial. ABIOMED currently manufacturers and sells the BVS, an advanced heart assist device for the temporary support of all patients with failing but potentially recoverable hearts.

This News Release contains forward-looking statements forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
, including statements regarding BVS growth and clinical and commercial success with the AbioCor. ABIOMED's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainty associated with development, testing and regulatory approvals, anticipated future losses, complex manufacturing, high quality requirements, unproven unproven Dubious, nonscientific, not proven, quack, questionable, unscientific adjective Relating to that which has not been validated by reproducible experiments or other scientific methods for determining effect or efficacy  markets for products under development, competition, technological change, government regulation, dependence on limited sources of supply, future capital needs and uncertainty of additional funding, dependence on third-party reimbursement Reimbursement

Payment made to someone for out-of-pocket expenses has incurred.
 and other risks detailed in the Company's filings with the Securities and Exchange Commission. Investors are cautioned that all such statements involve risks and uncertainties. Readers are cautioned not to place undue reliance on these 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 after the date hereof or to reflect the occurrence of unanticipated events.


                             ABIOMED, Inc.
                         FINANCIAL HIGHLIGHTS

              CONSOLIDATED OPERATING RESULTS (Unaudited)
(In thousands,
except per share
data)                                        Three Months Ended
                                             June 30,    June 30,
                                               2001        2000

Product revenues                            $  5,747    $  5,504
Funded research and development                  245         355
Total operating revenues                       5,992       5,859

Cost of product revenues                       1,991       1,935
R&D expenses                                   7,144       4,491
S,G&A expenses                                 4,144       2,977
Total costs and expenses                      13,279       9,403

Interest and other income                        986       1,559

Net loss                                    $ (6,301)   $ (1,985)

Net loss per share                          $  (0.30)   $  (0.10)


Weighted average shares outstanding           20,792      20,464

                 CONDENSED CONSOLIDATED BALANCE SHEET

                                            June 30,     March 31,
                                              2001         2001
                                          (unaudited)   (audited)

Cash and Marketable Securities              $ 88,092    $ 92,498

Current Assets                              $101,130    $106,966

Total Assets                                $111,571    $118,013

Current Liabilities                         $  8,875    $  8,967

Long-term Liabilities                       $     91    $    368

Stockholders' Equity                        $102,605    $108,678

COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jul 26, 2001
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