DANVERS,
Mass. (November 1, 2004) – ABIOMED, Inc. (NASDAQ: ABMD) today
released financial results for the second quarter of fiscal year 2005
ended September 30, 2004.
- Highlights include:
- Total revenues of $10.4 million, the highest quarter revenue
in the company's history.
- Revenue growth of 95% measured against the comparable quarter
of the last year, and 40% over the prior quarter.
- Profitability based on product revenues for the first time
in company history, with earnings per share of $0.02, compared
to a loss of $0.13 for the same quarter last year. The company's
goal is to be profitable based on ongoing business operations
for the year.
- Revenues of 17.9 million for the six months ended September
30, 2004, compared to $10.4 million for the six months ended September
30, 2003, growth of 71%.
- AB5000 revenue growth of 129% in comparison to the first quarter
of the fiscal year.
- Submission in September for FDA approval of the AbioCor Implantable
Replacement Heart under a Humanitarian Device Exemption.
- The appointment of a new General Manager, Frank Menzler, in
Europe, the addition of distributors in Latin America and Canada,
and the continued expansion of ABIOMED's sales and clinical staff.
"Our performance this quarter validates the potential of
a tremendously under-served segment of the mechanical circulatory
support market: Bridge to Recovery," said Michael R. Minogue,
CEO and President of ABIOMED. "Our team is engaged and energized
by the momentum we've created, but we are not fully satisfied because
we know we've realized only a fraction of the overall potential.
We remain committed to our company creed to save lives, lead in
technology and innovation, be profitable, and create a winning culture
that drives our success. While the AbioCor represents our future
potential to extend lives for end-stage heart failure patients,
we are also focused on our core business, heart recovery, which
has the potential to save tens of thousands of people each year."
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.
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.
- Contrary to the common misconception that it can be determined
within five days if a patient will recover, ABIOMED's data shows
that 84% of AB5000 patients who recover do so after day five on
support. For example, a woman in Florida recovered after 15 days
on support. The physicians realized her heart had recovered during
her heart transplant surgery. She has returned home with her natural
heart. Had she received a transplant, this 34-year-old mother
of two would have had a 65% chance of surviving five years.
- Early implantation has been demonstrated to be a key factor
in survival for patients requiring temporary circulatory support.
According to Dr. Nicholas Smedira, Surgical Director of Cardiac
Transplantation and Mechanical Circulatory Support at the Cleveland
Clinic, "the success of acute circulatory support systems
like the AB5000 may be predicated on early use following a cardiac
event, and early transfer to advanced cardiac centers."
- Another key factor in the success of patients put on the BVS
and AB5000 systems is the fact that patients can be switched from
one device to another without re-opening the chest. Reducing the
need for surgery greatly reduces the risk of adverse events such
as infection and bleeding, and helps support recovery.
Financial highlights of the quarter included:
Revenues. Revenues for the quarter ended September
30, 2004 were $10.4 million, 95% above the $5.3 million reported
for the quarter ended September 30, 2003. Sales of the new AB5000
system represented the largest portion of the increase. BVS 5000
revenues also increased significantly. For the six months ended
September 30, 2004, revenues were $17.9 million, or 71% higher than
the $10.4 million reported for the six months ended September 30,
2003. International sales accounted for 5% and 11% of total product
revenue during the six months ended September 30, 2004 and 2003,
respectively.
Net Profit or Loss. During the quarter ended September
30, 2004 we showed a net profit of $0.5 million, or $0.02 per share.
This compares to a loss of $2.8 million or $0.13 per share for the
three months ended September 30, 2003. Our higher product revenues
during the recent quarter contributed to our first profitable quarter
in the past eight fiscal years, and first profitable quarter based
on product revenues in company history. For the six months ended
September 30, 2004 we incurred a net loss of $1.9 million, or $0.09
per share. This compares to a net loss of $5.9 million, or $0.28
per share for the six months ended September 30, 2003.
Cost of Product Revenues. Cost of product revenues
as a percentage of product revenues was 23% in the three months
ending September 30, 2004 compared to 27% in the three months ending
September 30, 2003. Cost of product revenues as a percentage of
product revenues was 24% in the six months ending September 30,
2004 compared to 26% in the six months ending September 30, 2003.
Research and Development Expenses. Research and
development expense was $3.4 million in the three months ended September
30, 2004, compared to $3.6 million in the corresponding three months
of 2003; a reduction of $0.2 million, or 5%. Research and development
expenses during the quarter consisted of continued clinical and
development efforts related to the AbioCor, the AbioCor II and our
continued efforts to enhance and extend the existing BVS and new
AB5000 product offerings. Research and development expenses decreased
by $1.0 million, or 13% to $6.7 million in the six months ended
September 30, 2004, from $7.7 million in the six months ended September
30, 2003.
Selling, General and Administrative Expenses.
Selling, general and administrative expenses increased by $1.1 million,
or 34%, to $4.3 million in the three months ended September 30,
2004, from $3.2 million in the three months ended September 30,
2003. The increase is the result of higher selling and marketing
expenses as we focus more resources on expanding commercial development
of our new and existing products. We spent more on headcount, including
sales and clinical labor, tradeshows and marketing materials than
during the same quarter of the prior year. Commission expenses also
increased as a result of higher revenues. We also continued to incur
additional costs for recruiting and relocating senior additions
to our management team. Selling, general and administrative expenses
increased by $2.8 million, or 44%, to $9.2 million in the six months
ended September 30, 2004, from $6.4 million in the six months ended
September 30, 2003.
Liquidity and Capital Resources. We have supported
our operations primarily with net revenues from sales of our BVS
and AB5000 circulatory assist product line, government contracts
and proceeds from our equity financings. As of September 30, 2004,
our cash, cash equivalents, short-term marketable securities and
long-term investments totaled $43.5 million. During the six months
ended September 30, 2004, cash used by operating activities was
$4.4 million, 24% less than the $5.8 million used by operations
in the six months ending September 30, 2003. We increased inventory
by $1.9 million as of September 30, 2004 in anticipation of new
AB5000 sales and our receivables increased by $0.8 million as a
result of our higher revenues. Both of these items offset a portion
of the improvement in operating cash flow resulting from the lower
net loss. Net cash consumption from all activities, as determined
by the net change in cash, short-term marketable securities and
long-term investments, was $2.0 million for the six months ended
September 30, 2004, compared to $5.7 million consumed for the six
months ended September 30, 2003. During the six months ended September
30, 2004, the Company benefited from $2.8 million in cash proceeds
as a result of employee stock option exercises and employee participation
in the Company's stock purchase plan.
ABIOMED will be hosting a conference call with analysts and investors
to discuss fiscal 2005 second quarter results. This conference call
is scheduled for Monday, November 1st at 11:00 a.m. Eastern Time.
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.
###
Media Contact:
Andrea tenBroek
Communications Specialist
(978) 646-1419
mediarelations@abiomed.com
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