Exhibit 99.1
AbioMed Announces Fiscal Second Quarter 2008 Results and Reaffirms Full Year
Fiscal 2008 Revenue Guidance
-- Revenue up 5% to $11.4 million
-- Impella 2.5 High-Risk PCI Pivotal Trial Conditionally Approved
in Late Fiscal Q2 2008
-- Customer Orders of $1.6 million for Impella 2.5 Pivotal Trial
and AbioCor Not Included in Fiscal Q2 Revenue
-- Impella Disposable Revenue up 140%
DANVERS, Mass.--(BUSINESS WIRE)--Nov. 8, 2007--Abiomed, Inc.
(NASDAQ: ABMD) today announced fiscal second quarter 2008 revenue of
approximately $11.4 million, up approximately 5% compared to revenue
of $10.9 million for the same period of fiscal 2007. Revenue for the
six months ended September 30, 2007 was approximately $25.4 million,
up approximately 6% compared to revenue of approximately $23.9 million
in the first six months of fiscal 2007.
Recent financial and operating highlights include:
-- While there are no guarantees for a 510(k) clearance, current
informal FDA feedback is that the Impella(R) 2.5 is on the
substantially equivalent (SE) path, and that the device does
not pose any new questions as compared to the predicate
devices. Abiomed is preparing responses to the FDA questions
on the 510(k) submission for the Impella 2.5.
-- During the second quarter of fiscal 2008 compared to the
second quarter of fiscal 2007, Impella disposable revenue
increased 140%, AB5000 disposable revenue increased 20%, and
BVS(R) 5000 disposable revenue declined 10%.
-- Impella console revenue increased 100% and AB5000(TM) console
revenue decreased 48%. The Company's iPulse(TM) combination
console continues to be under regulatory review by the FDA for
PMA supplement approval. The Company expects FDA supplement
approval for the iPulse in the third quarter of fiscal 2008,
which ends December 31, 2007; however there is no guarantee
that approval will be received.
-- Abiomed received approval in late fiscal Q2 2008 for one of
its two submissions for a pivotal study with Impella 2.5. The
high-risk PCI (percutaneous coronary intervention) pivotal
study approval is for the Impella 2.5 at up to 150 hospitals.
-- Customer orders of $1.6 million related to both the Impella
2.5 pivotal trial and AbioCor were not included in revenue for
the second quarter of fiscal 2008. Impella orders were
deferred due to investigational review board (IRB) processes
and training requirements.
-- Abiomed is waiting for FDA approval for its Impella 2.5 acute
myocardial infarction (AMI) shock pivotal trial, which is
expected sometime in the quarter ending December 31, 2007;
however there is no guarantee that approval will be received.
-- The second quarter of fiscal 2008 GAAP net loss was $9.4
million, or $.29 per share, which included stock option and
other stock-based compensation expense of $1.3 million, or
$.04 per share. The net loss for the second quarter of fiscal
2007 was $8.7 million, or $.33 per share and included stock
option and other stock-based compensation expense of $1.6
million, or $.06 per share.
"We were pleased with the global Impella revenue growth for the
summer quarter, especially in Europe. Overall, we are excited and
prepared to enter the U.S. market with our strategic platforms of
Impella and iPulse products when we receive FDA approvals," said
Michael R. Minogue, Chairman, CEO and President of Abiomed. "We have
started the Impella 2.5 pivotal trial for high-risk PCI following a
very successful TCT Conference and we continue to work toward
obtaining 510(k) clearance of the Impella 2.5 and approval to begin
our Impella 2.5 AMI pivotal study. As we stated at the start of the
fiscal year, the revenue ramp in the U.S. is dependent on regulatory
approvals and would be second half loaded."
Abiomed is reaffirming its full-year fiscal 2008 revenue growth
estimate of greater than 20%, based on the Company's expected timing
of U.S. clinical trials and global regulatory approvals of new
products (Impella 2.5, iPulse supplement, and AbioCor supplement).
The Company will release complete second fiscal quarter 2008
results on November 8, 2007, and host a conference call to discuss the
results that day at 8:00 a.m. ET. Michael R. Minogue, Chairman, Chief
Executive Officer and President, and Daniel J. Sutherby, Chief
Financial Officer, will host the conference call.
To listen to the call live, please tune into the webcast via
http://investor.abiomed.com or dial 866-202-4367; the international
number is 617-213-8845. The access code is 59616122. A replay of this
conference call will be available beginning at 10 a.m. ET on November
8, 2007 through 11:59 p.m. ET on November 22, 2007. The replay phone
number is 888-286-8010; the international number is 617-801-6888. The
replay access code is 15308576.
ABOUT ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc., is a leading
provider of medical devices that provide circulatory support to acute
heart failure patients across the continuum of care in heart recovery.
Our products are designed to enable the heart to rest, heal and
recover by improving blood flow and/or performing the pumping of the
heart. For additional information please visit: www.abiomed.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, the
expected timing of regulatory approvals on various products including
iPulse and the Impella product lines, 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 for its products including iPulse and the
Impella product lines, 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
risk factors included in its most recently filed annual report 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. and Subsidiaries
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share data)
Three Months Ended Six Months Ended
September 30, September 30,
------------------ -------------------
2007 2006 2007 2006
--------- -------- --------- ---------
Revenue:
Products $11,272 $10,867 $ 25,173 $ 23,875
Funded research and
development 83 19 246 19
--------- -------- --------- ---------
11,355 10,886 25,419 23,894
--------- -------- --------- ---------
Costs and expenses:
Cost of product revenue
excluding amortization of
intangibles 2,877 2,925 6,409 6,408
Research and development 5,832 5,285 11,348 10,704
Selling, general and
administrative 12,257 11,046 24,699 20,438
Arbitration decision (26) --- 1,206 ---
Expensed in-process research
and development --- --- --- 800
Amortization of intangible
assets 386 504 766 870
--------- -------- --------- ---------
21,326 19,760 44,428 39,220
--------- -------- --------- ---------
Loss from operations (9,971) (8,874) (19,009) (15,326)
--------- -------- --------- ---------
Other income:
Investment income 802 286 1,709 601
Other income, net (68) 15 (67) 159
--------- -------- --------- ---------
734 301 1,642 760
--------- -------- --------- ---------
Net loss before provision for
income taxes (9,237) (8,573) (17,367) (14,566)
Provision for income taxes 145 103 290 241
--------- -------- --------- ---------
Net loss $(9,382) $(8,676) $(17,657) $(14,807)
========= ======== ========= =========
Basic and diluted net loss per
share $ (0.29) $ (0.33) $ (0.55) $ (0.56)
Weighted average shares
outstanding 32,422 26,611 32,379 26,553
Abiomed, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except share data)
September March 31,
30, 2007 2007
-----------------------
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 59,518 $ 69,646
Short-term marketable securities --- 5,479
Accounts receivable, net 8,615 10,932
Inventories 14,600 8,567
Prepaid expenses and other current assets 1,661 1,758
------------ ----------
Total current assets 84,394 96,382
Property and equipment, net 7,033 5,764
Intangible assets, net 6,989 7,329
Goodwill 28,396 26,708
------------ ----------
Total assets $ 126,812 $ 136,183
============ ==========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 5,312 $ 5,185
Accrued expenses 6,582 7,017
Deferred revenue 774 695
------------ ----------
Total current liabilities 12,668 12,897
Long-term deferred tax liability 2,458 1,191
Other long-term liabilities 275 ---
------------ ----------
Total liabilities 15,401 14,088
------------ ----------
Commitments and contingencies
Stockholders' equity:
Class B Preferred Stock, $.01 par value --- ---
Authorized - 1,000,000 shares; Issued
and outstanding - none
Common stock, $.01 par value 325 323
Authorized - 100,000,000 shares;
Issued - 32,524,030 shares at
September 30, 2007 and 32,254,577
shares at March 31, 2007;
Outstanding - 32,513,011 shares at
September 30, 2007 and 32,243,558
shares at March 31, 2007
Additional paid-in-capital 298,248 292,467
Accumulated deficit (189,121) (171,189)
Treasury stock at cost - 11,019 shares at
September 30, 2007 and at March 31, 2007 (116) (116)
Accumulated other comprehensive income 2,075 610
------------ ----------
Total stockholders' equity 111,411 122,095
------------ ----------
Total liabilities and stockholders' equity $ 126,812 $ 136,183
============ ==========
CONTACT: Abiomed, Inc.
Daniel J. Sutherby, 978-777-5410
Chief Financial Officer
ir@abiomed.com
or
Brodeur
Heather Nevers, 617-587-2814
Media Relations
hnevers@brodeur.com