| 111%
Increase in AB5000 VAD Revenue and Record Utilization
DANVERS, Mass. (August 4, 2005)—ABIOMED,
Inc. (NASDAQ: ABMD) today released financial results for the fiscal
first quarter ended on June 30, 2005. Revenue grew 13% to $8.4 million
in the first quarter of 2006.In addition, the Company's AB5000 Ventricle
sales grew 111% and units increased 107% over prior year first quarter.
During the quarter, the Company implemented a new pilot program
for console rentals which represents potential future revenue. Significant
events continued to progress during the quarter such as: the AbioCor
FDA panel, completing the acquisition and integration of Impella
CardioSystems, and tracking multiple clinical milestones.
Financial and operating highlights for the first quarter include:
- AB5000 Ventricle revenue increased 111% and unit sales grew
107% over the same period last year. A record number of units
were shipped to open heart centers (non-transplant centers), a
growth market for the AB5000.
- The AB5000 device was used to treat more patients this quarter
than any other quarter in the Company's history. The Company's
hospitals are continuing to increase survival and recovery rates
in patients. Per ABIOMED's latest clinical review, 75% of myocarditis
survivors and 64% of heart attack cardiogenic shock survivors,
are recovering their native heart.
- In Europe, ABIOMED's sales increased 135% on combined ABIOMED
and Impella products, with Impella reaching an all time high in
total revenue.
- ABIOMED has more than doubled its AB5000 users in transplant
and non-transplant centers in the U.S. since the first quarter
of last year.
Recently, the Centers for Medicare and Medicaid Services (CMS)
updated the reimbursement for the successful recovery of the native
heart with external ventricular assist devices (VADs). This change
will impact the AB5000 and BVS 5000 devices by providing more than
70% increased reimbursement for customers who can recover their
patients' hearts. ABIOMED provides additional customer assistance
with multi-year customer support agreements which increased in sales
by 81% over prior quarter. Through the use of Six Sigma analysis,
these programs are designed to improve clinical and financial outcomes
of a hospital's recovery program.
ABIOMED is currently the only company with FDA labeling on ventricular
assist devices for all recovery indications. To date, more than
7,000 patients worldwide have been supported with these devices
for FDA approved indications such as acute myocardial infarct cardiogenic
shock, myocarditis, postpartum cardiomyopathy, ventricular septal
defect, refractory dysrhythmias, pulmonary embolism, cardiac trauma,
failed transplants, right ventricular assistance with implantable
LVAD (Left VAD), and post cardiotomy cardiogenic shock (PCCS).ABIOMED's
devices encourage recovery as they are gentle on the heart, utilizing
thin cannulae inserted through a small incision, rather than more
traumatic bridge-to-transplant devices that core the ventricles.
The ABIOMED AB5000 also allows patients to walk with the support
of the console, which may help them recover.
"This quarter AB5000 devices supported more patients than ever
before. Our physicians are excited about the recovery opportunity
and seeing patients heal their own hearts," said Michael R. Minogue,
Chairman, CEO and President of ABIOMED."ABIOMED offered a new pilot
program of console rentals for AB5000 this quarter. The pilot was
designed to provide new and existing customers with flexibility
within their capital budgets, as well as to improve penetration
in new sales territories."
ABIOMED continued to expand its business with the addition of
several new hires in its field sales force and two regional vice
presidents of sales. ABIOMED recently merged its experienced clinical
team and sales force under the sales leaders, to work more closely
to focus on recovery outcomes. This merger was designed to better
serve ABIOMED customers and increase utilization of the AB product
offerings.
In addition, ABIOMED continued to progress towards potential FDA
approval of new products. The AbioCor Implantable Replacement Heart
was reviewed by the Circulatory System Devices Panel of the FDA
this quarter. After several rounds of voting, the panel requested
additional information on the AbioCor. ABIOMED has met with the
FDA and continues to submit additional data. FDA approval would
provide patients who have serious heart failure with no other alternative,
the option for the first completely self-contained artificial heart.
With the purchase of Impella, ABIOMED gained technology that has
supported hundreds of patients in Europe under CE Mark approval.
These devices are primarily used in the catheterization lab, of
which there are approximately 1,600 U.S. hospitals with this capability.
Pending FDA approval, this new customer segment will have access
to Impella products. The Impella Recover 2.5 and 5.0 make it possible
to provide support to the left ventricle without opening the chest
(sternotomy).The pumps are inserted quickly via the femoral artery
and advanced with the help of a guidewire into the left ventricle.
The ImpellaRecover® LP 2.5 is a minimally invasive ventricular
unloading catheter that delivers up to 2.5 liters of blood per minute
from the left ventricle into the ascending aorta, providing the
heart with active support in extremely critical situations. The
Impella Recover® LP 5.0 provides enhanced hemodynamic support,
up to 5.0 liters per minute. Once in place, it can provide support
for up to seven days.
FINANCIAL OVERVIEW
Financial results for fiscal first quarter ended June 30, 2005
are summarized in the attached table. Financial highlights of the
quarter included:
Revenues. Revenues increased by $1.0 million, or 13%,
from $7.4 million in fiscal first quarter 2005 to $8.4 million in
fiscal first quarter 2006. This is the highest revenue ever in a
first quarter and reflects the growth on AB5000 ventricles and the
record revenue in our European operations.
Cost of Product Revenues. Cost of product revenues as
a percentage of product revenues was 28% for fiscal first quarter
2006 from 24% in the same period last year. The difference in product
margin is primarily due to the consolidation of Impella products
into the total results.
Research and Development Expenses. Research and development
expenses increased by $0.9 million, from $3.3 million in fiscal
first quarter 2005 to $4.2 million in fiscal first quarter 2006.
The change reflects ABIOMED's continuous investment in new products
and platforms in circulatory care to be introduced into the market
in the next 24 months, plus the additional R&D associated with
Impella operations.
Expensed In-Process Research and Development. There was
a $12.4 million write off for the fair value of purchased in-process
research and development resulting from the acquisition of Impella.
Selling, General and Administrative Expenses. Selling,
general and administrative expenses increased by $2.4 million, or
49%, from $4.9 million in the first fiscal quarter last year to
$7.3 million in the first fiscal quarter ended June 30, 2005. The
increase is correlated to the higher volume in total revenue with
the expansion of sales and marketing activities. There were additional
expenses related to the Impella operations and acquisition.
Net Loss. Net loss for the quarter on a GAAP basis was
$17.6 million, or $0.73 per share. Excluding $12.4 million attributable
to a non-cash research and development expense associated with the
Impella acquisition, the loss on a non-GAAP basis was $5.2 million
or $0.22 per share.
CONFERENCE CALL AND WEBCAST INFORMATION:
ABIOMED will be hosting a conference call and webcast with analysts
and investors at 11:00 AM Eastern on August 4, 2005. To participate
in this call within the U.S. and Canada, dial 866-250-3615; international
callers should dial 303-262-2004. The conference ID is 6020848.
A replay of the call will be available four hours after the call
and will be available for one week. To access the replay within
the U.S. and Canada, dial 888-203-1112; international callers should
dial 719-457-0820. A webcast of the call, which will be live and
then archived for two weeks, will also be available at www.abiomed.com.
ABOUT ABIOMED
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. In Europe, ABIOMED offers the Impella®
Recover™ minimally invasive cardiovascular support systems
under CE Mark approval. The Company’s AbioCor® Implantable
Replacement Heart was the subject of an initial clinical trial 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. For additional information please visit:
www.abiomed.com.
Contacts:
Liza Heapes
ABIOMED, Inc.
Communications Specialist
(978) 646-1668
mediarelations@abiomed.com
Investor Relations Contact:
Rx Communications Group, LLC
Melody Carey
(917) 322-2571
mcarey@rxir.com
FORWARD-LOOKING STATEMENTS
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.
###
ABIOMED, Inc.
FINANCIAL HIGHLIGHTS
CONSOLIDATED OPERATING RESULTS (Unaudited)
(In thousands, except per sharedata) |
Three Months Ended |
|
June 30, 2005 |
June 30, 2004 |
|
Product Revenues |
$ 8,400 |
$ 7,366 |
Funded Research & Development |
23 |
75 |
| Total Operating Revenues |
8,423
|
7,441
|
Cost of Product Revenues |
2,333 |
1,757 |
R&D Expenses |
4,208 |
3,308 |
S,G&A Expenses |
7,312 |
4,917 |
Expensed in-Process Research
and Development |
12,371 |
-- |
Total Operating Expenses |
26,224 |
9,982 |
|
Loss from Operations |
(17,801) |
(2,541) |
|
Other Income, net |
226 |
162 |
|
Net Loss |
$ (17,575) |
$ (2,379) |
|
|
|
Net Loss per Share |
$ (0.73) |
$ (0.11) |
|
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
|
June 30,
2005 |
March 31,
2005 |
Cash and Investments |
$ 39,231 |
$ 43,617 |
|
|
|
Working Capital |
$ 46,427 |
$ 50,342 |
|
|
|
Goodwill |
$ 19,187 |
-- |
|
|
|
Total Assets |
$ 86,124 |
$ 61,061 |
|
|
|
Current Liabilities |
$ 7,337 |
$ 4,882 |
|
|
|
Stockholders' Equity |
$ 78,787 |
$ 56,179 |
|