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ABIOMED Announces Results for Fiscal Quarter and Year Ended March 31, 2002.


Business Editors

DANVERS, Mass.--(BUSINESS WIRE)--May 16, 2002

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 released financial results for its fiscal quarter and year ended March 31, 2002 ("fiscal 2002") and commented on the progress of both its 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 line and its initial human trial with its AbioCor(TM) Implantable Replacement Heart ("AbioCor").

Product revenues achieved record levels for both the fiscal quarter and fiscal year ended March 31, 2002. Product revenues totaled $6.9 million in the quarter ended March 31, 2002 compared to $5.9 million in the same quarter last year. For the fiscal years ended on the same dates, product revenues were $22.5 million in fiscal 2002 compared to $22.0 million in fiscal 2001. The increases primarily reflect increased sales of BVS blood pumps in the U.S., Europe and Japan.

The Company's expenditures for product research and development during fiscal 2002 were approximately $29.5 million, approximately 80% of which were related to clinical trials for the AbioCor and continued development, manufacturing and testing of further improved versions of the AbioCor as well as ABIOMED's smaller-sized implantable replacement heart based on technology acquired in 2000 from the Pennsylvania State University Pennsylvania State University, main campus at University Park, State College; land-grant and state supported; coeducational; chartered 1855, opened 1859 as Farmers' High School. .

"The fiscal year just ended has been the most rewarding year in ABIOMED's history," said Chairman and Chief Executive Officer Dr. David M. Lederman. "We have achieved numerous milestones in replacement heart technology: the first clinical implant implant /im·plant/ (im-plant´) to insert or to graft (tissue, or inert or radioactive material) into intact tissues or a body cavity.  of a totally implantable replacement heart, the AbioCor; the first discharge to home of a replacement heart patient; as well as an aggregate total of well over two patient-years of replacement heart support. Robert Tools Robert L. Tools (July 31 1942 - November 30 2001), was the world's first recipient of a fully self-contained artificial heart called AbioCor. The operation took place on July 2, 2001. He survived for 151 days without a living heart. Dr. , Bobby Harrison, James Quinn James Quinn is the name of:
  • James Quinn (athlete), "Jimmy", the gold-medal winning American athlete at the 1928 Summer Olympics
  • James Quinn (footballer), the Northampton Town F.C.
, Tom Christerson, and the other heroic he·ro·ic
adj.
Relating to a risky medical procedure that may endanger the patient but also has a possibility of being successful, whereas lesser action would result in failure.
 enrollees in the AbioCor clinical trial and their devoted families have helped to demonstrate the feasibility of a replacement heart capable of supporting a good quality of life. Our task now is to demonstrate that we can make this achievement a consistent clinical reality, without serious side effects Side effects

Effects of a proposed project on other parts of the firm.
, for a high proportion of patients. We welcome the challenge of completing successfully the ongoing clinical study. Although this clinical milestone and the corresponding regulatory approval are obviously on the critical path, our efforts today follow a strategy increasingly directed at preparing for the responsible commercial introduction of the AbioCor in the shortest possible time, to begin saving lives in a well-defined segment of the overall target population."

"The past year has also been very important for our BVS product line," Dr. Lederman continued. "Our sales team, the very best in our industry, capped a positive year with a record fourth quarter performance. The BVS continues to be the most successful and widely-used device in the treatment of patients for reversible reversible,
adj capable of going through a series of changes in either direction, forward or backward (e.g., reversible chemical reaction).

reversible hydrocolloid,
n See hydrocolloid, reversible.
 heart failure. Our unmatched clinical support team, our dedicated customer service organization, and our strong manufacturing group all contributed to last year's achievements, and provide a solid foundation for continued growth in the coming years. We are particularly pleased that our European European

emanating from or pertaining to Europe.


European bat lyssavirus
see lyssavirus.

European beech tree
fagussylvaticus.

European blastomycosis
see cryptococcosis.
 subsidiary, ABIOMED B.V., in its first year with a direct sales team, has already begun to show positive results, and that we have received our first order from Japan pursuant to the BVS's recent regulatory approval there. While BVS usage in both of these international territories is currently small, recent results and market feedback suggest more significant revenues in the coming years."

The Company reported that its BVS business line was again profitable in fiscal 2002 but overshadowed by its spending for new product research and development. The Company reported a fiscal 2002 net loss of $26.4 million, or $1.27 per share, compared to a net loss of $11.4 million, or $0.55 per share, in the prior year. The Company reported that its balance sheet at March 31, 2002 included $71.3MM in cash and short-term investments, $74.5 million in working capital and no long-term debt Long-Term Debt

Loans and financial obligations lasting over one year.

Notes:
For example debts obligations such as bonds and notes which have maturities greater than one year would be considered long-term debt.
.

Discussing the status of the AbioCor clinical trial, Dr. Robert T. V. Kung, ABIOMED's Senior Vice President and Chief Scientific Officer and the individual most central to ABIOMED's technical interaction with members of the AbioCor clinical sites, provided the following perspective: "Our current top priority is expanded AbioCor clinical trial success. We recognize that the pace of enrollment in the AbioCor trial has been slower than expected. That is in part an outgrowth of patient selection issues mandated by the rigor rigor /rig·or/ (rig´er) [L.] chill; rigidity.

rigor mor´tis  the stiffening of a dead body accompanying depletion of adenosine triphosphate in the muscle fibers.
 of our clinical trial design and the ethical and social ramifications ramifications nplAuswirkungen pl  of performing a highly experimental procedure on patients who are near death. We are working with our clinical partners to find patients who are sick enough to meet the trial's inclusion criteria
For Wikipedia's inclusion criteria, see: What Wikipedia is not.


Inclusion criteria are a set of conditions that must be met in order to participate in a clinical trial.
, capable of understanding the risks of the trial and personally giving truly informed consent, and not otherwise so compromised as to be beyond a good chance of surviving surgery and recovering. As we gain more experience with the AbioCor, these selection issues should become easier. Enrollment issues do not in any way reflect a shortage of patients who can benefit from the AbioCor once we move beyond the initial trial stage."

"The past few months have provided an extraordinary amount of data and experience about the support and management requirements of AbioCor patients," Dr. Kung continued. "We are today better prepared than ever, and we look forward to upcoming implants of the AbioCor in the U.S. and Europe, more certain than ever before that we will complete the trial successfully and without undue delay on our path to commercial introduction and broader clinical uses of the AbioCor."

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(TM) 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 United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
. The AbioCor has not been approved for commercial distribution, and is not available for use or sale outside of the initial clinical trial. ABIOMED currently manufactures and sells the BVS(R), a heart assist device for the temporary support of all patients with failing but potentially recoverable hearts.

ABIOMED will be hosting a conference call with analysts and investors to discuss its fiscal 2002 results. This conference call is scheduled for today, May 16th, at 11:00 a.m. EST EST electroshock therapy.

EST
abbr.
electroshock therapy
 and may be heard live via our website at www.abiomed.com.

This 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 the timing and clinical results of the AbioCor and continued BVS revenue growth. 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 detailed in the Company's filings with the Securities and Exchange Commission. 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 CIRCUMSTANCES, evidence. The particulars which accompany a fact.
     2. The facts proved are either possible or impossible, ordinary and probable, or extraordinary and improbable, recent or ancient; they may have happened near us, or afar off; they are public or
 that occur after the date of this Release or to reflect the occurrence of unanticipated events.

                             ABIOMED, Inc.
                         FINANCIAL HIGHLIGHTS

                    CONSOLIDATED OPERATING RESULTS


(In thousands, except      Three Months Ended     Twelve Months Ended
 per share data)
                          March 31,   March 31,  March 31,   March 31,
                            2002        2001       2002        2001

Product Revenues         $  6,915    $  5,872    $ 22,490    $ 22,017
Funded Research
 and Development              425         232       1,095       2,879

Total Operating
 Revenues                   7,340       6,104      23,585      24,896

Cost of Products Sold       2,581       2,042       7,285       7,375
R&D Expenses                7,616       6,136      29,488      22,671
S,G&A Expenses              4,269       3,557      16,196      12,411

Total Expenses             14,466      11,735      52,969      42,457

Interest Income
 and Other                    534       1,450       2,945       6,160

Net Loss                 $ (6,592)   $ (4,181)   $(26,439)   $(11,401)

Net Loss per Share       $  (0.32)   $  (0.20)   $  (1.27)   $  (0.55)

Weighted Average
 Shares Outstanding        20,927      20,721      20,869      20,583


               CONDENSED CONSOLIDATED BALANCE SHEET DATA
                                                  3/31/02     3/31/01

Cash and Marketable Securities                   $ 71,321    $ 92,498
Current Assets                                     83,818     106,966
Total Assets                                       92,803     118,013
Current Liabilities                                 9,317       8,967
Long-term Liabilities                                --           368
Stockholders' Equity                               83,486     108,678
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Comment:ABIOMED Announces Results for Fiscal Quarter and Year Ended March 31, 2002.
Publication:Business Wire
Geographic Code:1USA
Date:May 16, 2002
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