| U.S. Commercial Impella Revenue of $14.5 Million, Up 116%DANVERS, Mass., Feb 04, 2010 (BUSINESS WIRE) -- Abiomed,
Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart
support technologies, today reported third quarter fiscal 2010 revenue
of $22.8 million, up 32% compared to revenue of $17.3 million for the
same period of fiscal 2009.
Financial and operating highlights during the third quarter of fiscal
2010 include:
-
U.S. commercial Impella revenue totaled $14.5 million, up 116%
compared to revenue of $6.7 million in the third quarter of fiscal
2009. U.S. commercial reorders totaled $8.2 million, up 173% from $3.0
million in the third quarter of fiscal 2009.
-
Worldwide Impella revenue totaled $15.9 million, up 81% compared to
revenue of $8.8 million for the third quarter of fiscal 2009.
-
Approximately 425 U.S. commercial patients were treated with Impella(R)
2.5, 5.0 or LD, a 166% increase compared to approximately 160
commercial patients in the third quarter of fiscal 2009. A total of
approximately 1,625 U.S. commercial patients have been treated with
Impella as of the end of the third quarter of fiscal 2010.
-
An additional 66 U.S. hospitals purchased Impella 2.5 for commercial
use during the quarter, bringing the total to 392 commercial customers.
-
Approximately 80% of Impella U.S. customers were upgraded to the new
Impella platform, which includes the Quick Setup Kit.
-
Twenty four patients were enrolled in the Protect II study, for a
total of 314 patients completed, or 48% of the 654 patients required.
-
Non-Impella revenue was $6.9 million, up 1% sequentially from the
second quarter of fiscal 2010 and 18% lower than the third quarter of
fiscal 2009.
-
Gross margin for the quarter was 75% compared to 74% in the third
quarter of fiscal 2009.
-
The GAAP net loss was $4.6 million, or $0.12 per share, compared to a
GAAP net loss of $7.7 million, or $0.21 per share for the third
quarter of fiscal 2009.
-
The non-GAAP net loss, after excluding stock-based compensation
expense of $2.2 million and intangibles amortization expense of $0.4
million, was $2.0 million, or $0.05 per share, compared to the
non-GAAP net loss of $5.4 million, or $0.15 per share, for the third
quarter of fiscal 2009, after excluding stock-based compensation
expense of $1.9 million and intangibles amortization expense of $0.4
million.
-
Cash burn for the third quarter was $0.6 million, with cash, cash
equivalents plus short and long-term marketable securities totaling
$51.7 million compared to $52.3 million at the end of the second
fiscal quarter of 2010.
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IMPELLA US COMMERCIAL LAUNCH
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Growth |
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Q2'09 |
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Q3'09 |
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Q4'09 |
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Q1'10 |
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Q2'10 |
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Q3'10 |
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Q3'10
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vs. |
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Q3'09 |
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# of Patients per Quarter
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100
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160
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261
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341
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338
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425
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166%
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Avg. # of Patients Supported per Week
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8
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12
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20
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26
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26
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33
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175%
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# of Hospitals added per Quarter
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108
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55
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66
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47
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50
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66
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20%
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Total U.S. Commercial Revenue
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$6.2M
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$6.7M
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$9.1M
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$10.5M
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$12.1M
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$14.5M
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116%
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U.S. Reorder Revenue (Contribution to Total Commercial
Revenue)
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$2.0M
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$3.0M
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$4.9M
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$6.4M
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$6.6M
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$8.2M
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173%
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Total Worldwide Impella Revenue (ROW,
Commercial & Trial)
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$10.5M
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$8.8M
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$11.2M
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$12M
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$13.2M
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$15.9M
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81%
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"We posted a record fiscal third quarter driven by year over year
patient utilization growth of 166% and strong operational performance",
said Michael R. Minogue, Chairman, President and Chief Executive Officer
of Abiomed. "By the end of the quarter, the majority of sites had
received our new Impella 2.5 Quick Setup Kit which significantly reduces
set up times and positions us well for urgent and emergent patient
situations. In addition, we reduced our cash burn to $600k. We continue
to execute our Impella strategy of demonstrating clinical utility, ease
of use and physician and field training."
Abiomed today updated revenue guidance for the full fiscal year 2010 to
reflect a fiscal fourth quarter focus on existing site Impella
utilization and training rather than on new Impella site openings and
the legacy business. For the full fiscal year 2010, the Company
reaffirms Impella revenue guidance in the range of $55 million to $58
million, reflecting a growth rate for Impella of 50% to 60%, but is
revising its total revenue guidance from a range of $86 million to $91
million to a range of $84 million to $86 million.
The Company will host a conference call on Thursday, February 4, 2010 at
8 a.m. ET to discuss its third quarter fiscal 2010 results. Michael R.
Minogue, Chairman, Chief Executive Officer and President, and Robert L.
Bowen, Vice President and 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 866.202.3109; the international number is 617.213.8844. The
access participant code is 44119781. A replay of this conference call
will be available beginning at 11 a.m. ET on February 4, 2010 through
11:59 p.m. ET on February 18, 2010. The replay phone number is
888.286.8010; the international number is 617.801.6888. The replay
access code is 51319497.
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.
USE OF NON-GAAP MEASURES
In addition to financial measures prepared in accordance with generally
accepted accounting principles (GAAP), this earnings announcement also
contains non-GAAP financial measures of net loss and net loss per share,
in each case excluding, where appropriate, stock-based compensation and
intangibles amortization, as well as cash burn, which we define as the
change in cash, cash equivalents, short and long-term marketable
securities and restricted securities. We believe that the inclusion of
these non-GAAP financial measures in this earnings announcement helps
investors to gain a meaningful understanding of our core operating
results and future prospects, and can also help investors who wish to
make comparisons between us and other companies on both a GAAP and a
non-GAAP basis, particularly with respect to stock based compensation
expenses. The non-GAAP financial measures included in this earnings
announcement are not meant to be considered superior to or a substitute
for results of operations prepared in accordance with GAAP. In addition,
the non-GAAP financial measures included in this earnings announcement
may be different from, and therefore may not be comparable to, similar
measures used by other companies. Although certain non-GAAP financial
measures used in this release exclude the accounting treatment of stock
based compensation expense and other items outlined in this release and
above, these non-GAAP measures should not be relied upon independently,
as they ignore the contribution to our operating results that is
generated by the incentive and compensation effects of the underlying
stock based compensation programs.
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
and expected regulatory approvals. 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, 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 and the most recently filed
Quarterly Report on Form 10-Q. 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, Impella, iPulse, BVS5000, AB5000, AbioCor and the Abiomed
logo are all trademarks of Abiomed. Other company and product names may
be trademarks of their respective owners.
|
| Abiomed, Inc. and Subsidiaries |
| Condensed Consolidated Balance Sheets |
| (in thousands, except share data) |
|
|
|
|
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|
December 31, 2009 |
|
March 31, 2009 |
|
|
(unaudited) |
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| ASSETS |
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Current assets:
|
|
|
|
|
|
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Cash and cash equivalents
|
|
$
|
3,236
|
|
|
$
|
1,785
|
|
|
Short-term marketable securities
|
|
|
48,476
|
|
|
|
55,394
|
|
|
Accounts receivable, net
|
|
|
14,400
|
|
|
|
15,724
|
|
|
Inventories
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|
|
12,629
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|
|
|
14,777
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|
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Prepaid expenses and other current assets
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|
|
822
|
|
|
|
809
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Total current assets
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|
|
79,563
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|
|
|
88,489
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Property and equipment, net
|
|
|
7,225
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|
|
|
7,792
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Intangible assets, net
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|
|
3,549
|
|
|
|
4,359
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|
|
Goodwill
|
|
|
39,595
|
|
|
|
31,295
|
|
|
Long-term marketable securities
|
|
|
---
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|
|
|
3,721
|
|
|
Other assets
|
|
|
302
|
|
|
|
302
|
|
|
Total assets
|
|
$
|
130,234
|
|
|
$
|
135,958
|
|
| LIABILITIES AND STOCKHOLDERS' EQUITY |
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|
|
|
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|
|
Current liabilities:
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
4,826
|
|
|
$
|
5,550
|
|
|
Accrued expenses
|
|
|
10,891
|
|
|
|
10,818
|
|
|
Deferred revenue
|
|
|
1,098
|
|
|
|
1,211
|
|
|
Total current liabilities
|
|
|
16,815
|
|
|
|
17,579
|
|
|
Long-term deferred tax liability
|
|
|
2,797
|
|
|
|
2,086
|
|
|
Other long-term liabilities
|
|
|
460
|
|
|
|
310
|
|
|
Total liabilities
|
|
|
20,072
|
|
|
|
19,975
|
|
|
Commitments and contingencies (Note 11)
|
|
|
|
|
|
|
|
Stockholders' equity:
|
|
|
|
|
|
|
|
Class B Preferred Stock, $.01 par value
|
|
|
---
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|
|
---
|
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|
Authorized - 1,000,000 shares; Issued and outstanding - none
|
|
|
|
|
|
|
|
Common stock, $.01 par value
|
|
|
375
|
|
|
|
367
|
|
|
Authorized - 100,000,000 shares; Issued - 37,541,415 shares at
December 31, 2009 and 36,736,843 shares at March 31, 2009; Outstanding
- 37,409,461shares at December 31, 2009 and
36,685,889 shares at March 31, 2009
|
|
|
|
|
|
|
|
Additional paid-in-capital
|
|
|
372,507
|
|
|
|
362,097
|
|
|
Accumulated deficit
|
|
|
(263,990
|
)
|
|
|
(243,991
|
)
|
|
Treasury stock at cost - 50,954 shares
|
|
|
(827
|
)
|
|
|
(827
|
)
|
|
Accumulated other comprehensive income (loss)
|
|
|
2,097
|
|
|
|
(1,663
|
)
|
|
Total stockholders' equity
|
|
|
110,162
|
|
|
|
115,983
|
|
|
Total liabilities and stockholders' equity
|
|
$
|
130,234
|
|
|
$
|
135,958
|
|
|
|
|
|
|
|
|
|
|
|
| Abiomed, Inc. and Subsidiaries |
| Condensed Consolidated Statements of Operations |
| (Unaudited) |
| (in thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
|
December 31, |
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
|
|
|
$
|
22,623
|
|
|
$
|
17,081
|
|
|
$
|
61,937
|
|
|
$
|
53,128
|
|
|
Funded research and development
|
|
|
|
176
|
|
|
|
190
|
|
|
|
797
|
|
|
|
499
|
|
|
Total Revenue
|
|
|
|
22,799
|
|
|
|
17,271
|
|
|
|
62,734
|
|
|
|
53,627
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenue excluding amortization of intangibles
|
|
|
|
5,772
|
|
|
|
4,519
|
|
|
|
16,290
|
|
|
|
14,939
|
|
|
Research and development
|
|
|
|
6,397
|
|
|
|
5,203
|
|
|
|
19,166
|
|
|
|
18,197
|
|
|
Selling, general and administrative
|
|
|
|
15,190
|
|
|
|
13,227
|
|
|
|
45,973
|
|
|
|
40,639
|
|
|
Amortization of intangible assets
|
|
|
|
382
|
|
|
|
362
|
|
|
|
1,107
|
|
|
|
1,199
|
|
|
|
|
|
27,741
|
|
|
|
23,311
|
|
|
|
82,536
|
|
|
|
74,974
|
|
|
Loss from operations
|
|
|
|
(4,942
|
)
|
|
|
(6,040
|
)
|
|
|
(19,802
|
)
|
|
|
(21,347
|
)
|
|
Other income and expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment income (expense), net
|
|
|
|
275
|
|
|
|
(1,709
|
)
|
|
|
372
|
|
|
|
(1,508
|
)
|
|
Gain on sale of WorldHeart stock
|
|
|
|
-
|
|
|
|
313
|
|
|
|
-
|
|
|
|
313
|
|
|
Other income (expense), net
|
|
|
|
62
|
|
|
|
(81
|
)
|
|
|
(141
|
)
|
|
|
(1
|
)
|
|
|
|
|
337
|
|
|
|
(1,477
|
)
|
|
|
231
|
|
|
|
(1,196
|
)
|
|
Loss before provision for income taxes
|
|
|
|
(4,605
|
)
|
|
|
(7,517
|
)
|
|
|
(19,571
|
)
|
|
|
(22,543
|
)
|
|
Income tax (benefit) provision
|
|
|
|
(40
|
)
|
|
|
182
|
|
|
|
428
|
|
|
|
600
|
|
|
Net loss
|
|
|
$
|
(4,565
|
)
|
|
$
|
(7,699
|
)
|
|
$
|
(19,999
|
)
|
|
$
|
(23,143
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
|
$
|
(0.12
|
)
|
|
$
|
(0.21
|
)
|
|
$
|
(0.54
|
)
|
|
$
|
(0.67
|
)
|
|
Weighted average shares outstanding
|
|
|
|
37,011
|
|
|
|
36,051
|
|
|
|
36,829
|
|
|
|
34,470
|
|

SOURCE: Abiomed, Inc.
Abiomed, Inc. Paula Carpinella, 978-646-1816 ir@abiomed.com |