| Ten
percent growth over prior year with record setting fourth quarter
Danvers, MA, May 27, 2004 -- ABIOMED, Inc. (NASDAQ:
ABMD) today released financial results for its fiscal year ended
March 31, 2004 ("fiscal 2004") and commented on significant
highlights of the most recent 12 months.
Financial and operating highlights for fiscal 2004 and important
recent developments include:
- Successful clinical market introduction of our new AB5000™
Circulatory Support System console and ventricle, culminating
in a formal product launch in April 2004. More than 30 centers
have already signed on and more than 75 patients supported.
- Total revenues of $25.7 million, 10% growth over the prior
year, driven by record revenues of $8.6 million in the fourth
quarter, 27% higher than the $6.8 million in revenues in the comparable
quarter of the prior year.
- A 48% reduction in net loss for the year, to $0.45 per share,
and a substantial reduction in the rate of cash consumption, demonstrating
consistent progress toward our goal of profitability of our existing
business operations.
- Continued progress toward achieving our goal of initial FDA
market approval for the AbioCor® Implantable Replacement Heart
under a Humanitarian Device Exemption, including three implants
in the last three months.
- Appointment of GE Healthcare executive Michael R. Minogue to
succeed ABIOMED's Chairman and founder Dr. David M. Lederman as
Chief Executive Officer and President in April 2004.
- Significant strategic hires to strengthen ABIOMED's management
capabilities, processes and systems.
"Fiscal 2004 was a step forward for ABIOMED, " Mr. Minogue
said. "Our fundamental mission is to unlock ABIOMED's full
potential with the proper strategy, processes and execution in both
the short and long term. ABIOMED's current products for mechanical
circulatory support represent a strong business opportunity in the
short term. This year, we introduced the AB5000 Circulatory Support
System, and we entered this segment of the market with the largest
existing installed base of consoles for circulatory assist. We also
offer the most flexible system available: both the BVS Blood Pump
and AB5000 Ventricle can be driven by the AB5000 Console, an advanced
computer platform with upgradeable software. This console is designed
to allow doctors to make best clinical decision for patients, as
well as the most cost-efficient one."
"In addition to the short term opportunity with our existing
products, the AbioCor represents the company's potential in the
future, with the market for the replacement heart estimated to be
more than $1 billion annually," Mr. Minogue added. "Not
only do we intend to seek commercial approval under a Humanitarian
Device Exemption for the AbioCor this year, but we also have development
underway on the AbioCor II."
Financial Results
Financial results for the year ending March 31, 2004 are summarized
in the attached table, and are detailed in ABIOMED's Form 10-K filed
today with the Securities and Exchange Commission. The following
are excerpted from our 10-K filing:
Product Revenues. Product revenues increased by $2.0 million, or
8%, from $23.1 million in fiscal 2003 to $25.1 million in fiscal
2004. The increase is attributable to sales of AB5000 consoles and
ventricles during the controlled clinical rollout that began in
the first fiscal quarter for the console and in the second fiscal
quarter for the ventricle…Going forward, we expect total
revenue growth of at least 10% annually driven by sales of AB5000
consoles and ventricles subsequent to the full product release in
April 2004.
Funded Research and Development Revenues. Contract revenues increased
by $0.5 million to $0.7 million in fiscal 2004 from $0.2 million
in fiscal 2003. As of March 31, 2004, our total backlog of research
and development contracts and grants was $0.3 million.
Cost of Product Revenues. Cost of product revenues as a percentage
of product revenues improved to 30% for fiscal 2004 from 32% in
fiscal 2003…We expect that the growth of AB5000 product revenues
will support continued margin improvement in future reporting periods.
Research and Development Expenses. Research and development expenses
decreased by $6.3 million, or 30%, from $20.6 million in fiscal
2003 to $14.3 million in fiscal 2004…The largest portion
of this decrease is attributable to reduced expenses incurred for
the AbioCor program.
Selling, General and Administrative Expenses. Selling, general
and administrative expenses decreased by $0.6 million, or 4%, from
$14.7 million in the prior year to $14.1 million in the fiscal year
ended March 31, 2004... As we plan to increase both sales and clinical
support staffing in order to support the ongoing release of the
AB5000 product, selling and clinical support costs are likely to
increase going forward.
Net Loss. Net loss for the year was approximately $9.4 million,
or $0.45 per share. This is a 48% reduction from the net loss of
approximately $18.2 million, or $0.87 per share, in the prior fiscal
year…Continued reduction of our net loss is an important
goal of management, and we anticipate moving into profitability
of our existing business operations before the end of fiscal 2005.
ABIOMED will be hosting a conference call with analysts and investors
to discuss its fiscal 2004 results. This conference call is scheduled
for today, May 27, at 11:00 A.M. Eastern Time and may be heard live
via our website at www.abiomed.com.
This Release contains forward-looking statements, including
statements regarding commercial development of ABIOMED's products,
the timing and clinical results of the AbioCor trial, and the Company's
progress toward 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 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 that occur after the date of this Release or to
reflect the occurrence of unanticipated events.
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 currently manufactures
and sells the AB5000™ Circulatory Support System and the BVS®
5000 Biventricular Support System for the temporary support of all
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.
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Media Contact:
Andrea tenBroek
Communications Specialist
(978) 646-1419
mediarelations@abiomed.com
Investor Relations Contact:
Edward E. Berger, Ph.D.
Vice President for Policy, Reimbursement and External Relations
(978) 646-1411
ir@abiomed.com
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