Protected PCI Utilization Growth of 70% in the
U.S.
DANVERS, Mass., Oct. 29, 2015 (GLOBE NEWSWIRE)
-- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of
breakthrough heart support technologies, today reported second
quarter fiscal 2016 revenue of $76.4 million, an increase of 47%
compared to revenue of $51.9 million for the same period of fiscal
2015. Second quarter fiscal 2016 GAAP net income was $7.7 million
or $0.17 per diluted share, an increase of 103% and 89%
respectively, compared to GAAP net income of $3.8 million or $0.09
per diluted share for the prior year period.
Financial and operating highlights
during the second quarter of fiscal 2016 include:
- Fiscal second quarter worldwide Impella® heart
pump revenue totaled $71.7 million, an increase of 53% compared to
revenue of $46.9 million during the same period of the prior fiscal
year. U.S. revenue grew 59% to $66.7 million from $42.0
million in the prior fiscal year with patient usage up
48%.
- The installed base for Impella 2.5 grew by an
additional 27 hospitals, bringing the installed customer base to
1,000 sites. As part of Abiomed's continued Impella CP® heart
pump launch, 45 new hospitals purchased Impella CP, bringing the
total number of Impella CP U.S. sites to 739.
- The Impella RP® heart pump installed base has a
goal of 60 sites for the entire fiscal year. As of the end of the
second quarter, the Company is ahead of schedule, with an
additional 31 hospitals that made initial purchases of the Impella
RP during the quarter, bringing the total number to 54
Impella RP U.S. sites.
- Gross margin for fiscal second quarter 2016 was
84.1% compared to 81.5% in the second quarter of fiscal
2015.
- Income from operations for the second quarter of
fiscal 2016 was $12.8 million, or 16.8% of revenue, compared to
$4.2 million, or 8.0% of revenue in the prior year
period.
- The Company generated $19 million in cash, cash
equivalents and marketable securities, totaling $175.5 million as
of September 30, 2015, compared to $156.4 million at June 30, 2015.
The Company continues to have no debt.
- At its annual Investor Day on August 11, Abiomed
outlined its long-term growth strategy and five-year vision for
revenues and demonstrated future products in development, which can
be accessed via webcast
here: http://edge.media-server.com/m/p/ckvn5o7f. The future
products, which were also recently displayed at the TCT 2015
conference, included:
- The Impella ECP(TM) (Expandable Cardiac Power)
heart pump on a complete 9 Fr Impella catheter and pump;
- The Next Generation Impella CP with an increased
flow of 4.5 liters/minute and smart sensor technology;
- The Impella 5.5, which can be implanted via
axillary (without a sternotomy), is designed with a 19 Fr pump on a
9 Fr catheter for months of flow of 5.5 liters per minute and
patient ambulation;
- The longer term Impella BTR(TM) (Bridge to
Recovery) heart pump, which can also be implanted via axillary
(without a sternotomy), is designed to provide up to a year of 5.5
plus flow driven by a wearable driver.
- The Company also announced the submission of its
U.S Food & Drug Administration (FDA) pre-market approval (PMA)
supplements in August. The supplements are requesting approval for
the Impella family of heart pumps (Impella 2.5, Impella CP and
Impella 5.0/LD). The submissions are requesting approval for a set
of indications related to the use of the Impella devices in
patients suffering cardiogenic shock following acute myocardial
infarction or cardiac surgery. A request for a longer duration of
support was also included.
- A key clinical paper titled, "Percutaneous left
ventricular assist device for high-risk percutaneous coronary
interventions: Real-world versus clinical trial experience," was
published in the American Heart
Journal during the second quarter. The paper, authored by
Mauricio Cohen et al., analyzed the results of high risk PCI
(percutaneous coronary intervention) patients in the U.S. Impella
(now cVAD(TM)) Registry and determined that real-world clinical
outcomes with the Impella 2.5 appeared to be favorable and
consistent compared with the randomized PROTECT II trial.
- Seth Bilazarian, MD, was announced as the new
Vice President of Interventional Cardiology Programs at Abiomed on
October 8.
- At the Cardiovascular Research Foundation's (CRF)
annual Transcatheter Cardiovascular Therapeutics (TCT) 2015
scientific sessions in October, there were over 25 Impella heart
pump presentations, 3 Protected PCI symposia and 5 live Impella
heart pump cases.
"We have had an exciting start to fiscal year 2016 with first half
revenue growth of 49% and establishment of Protected PCI(TM) as a
new indication. As evidenced by our patient growth and awareness at
TCT, Protected PCI has been validated by physicians that treat
higher risk patients requiring percutaneous hemodynamic support in
the cath lab," said Michael R. Minogue, Chairman, President and
Chief Executive Officer, Abiomed. "We are confident that in the
years ahead, Abiomed will deliver strong growth, support new
indications and countries, and launch new best in class products.
As always, Abiomed is committed to meaningfully impacting the lives
of our patients and helping our physicians improve outcomes."
FISCAL YEAR
2016 OUTLOOK
The Company is increasing its fiscal year 2016 guidance for total
revenue to be in the range of $305 million to $315 million, up from
$300 million to $310 million, representing an increase in revenue
of 32% to 37% from the prior year.
The Company is updating its fiscal year guidance
for GAAP operating margin to be in the range of 15% to 17%, from
the previous guidance range of 14% to 16%.
CONFERENCE
CALL
The Company will release financial results for the second quarter
of fiscal 2016. The Company will host a conference call to discuss
the results on Thursday, October 29, 2015, at 8:00 a.m. EDT.
Michael R. Minogue, Chairman, President and Chief Executive
Officer; Michael Tomsicek, 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 (855)
212-2361; the international number is (678) 809-1538. A
replay of this conference call will be available beginning at 11
a.m. EDT October 29, 2015 through 11:59 p.m. EDT on October 31,
2015. The replay phone number is (855) 859-2056; the international
number is (404) 537-3406. The replay access code is 55643535.
The ABIOMED
logo, ABIOMED, Impella, Impella RP and Impella CP are registered
trademarks of Abiomed, Inc. in the U.S.A. and certain foreign
countries. Impella ECP, Impella BTR, Protected PCI,
Recovering Hearts. Saving lives and cVAD are trademarks of Abiomed,
Inc..
ABOUT
ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc. is a leading
provider of medical devices that provide circulatory support.
Our products are designed to enable the heart to rest 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 includes forward-looking statements. These
forward-looking statements generally can be identified by the use
of words such as "anticipate," "expect," "plan," "could," "may,"
"will," "believe," "estimate," "forecast," "goal," "project," and
other words of similar meaning. These forward-looking
statements address various matters including, the development of
Abiomed's existing and new products, the Company's progress toward
commercial growth, the Company's guidance for fiscal 2016 revenue
and GAAP operating margins and future opportunities. Each
forward-looking statement contained in this press release is
subject to risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statement. Applicable risks and uncertainties include, among
others, uncertainties associated with development, testing and
related regulatory approvals, including the potential for future
losses, complex manufacturing, high quality requirements,
dependence on limited sources of supply, competition, technological
change, government regulation, litigation matters, future capital
needs and uncertainty of additional financing, and the risks
identified under the heading "Risk Factors" in the Company's Annual
Report on Form 10-K for the year ended March 31, 2015 and the
Company's Quarterly Report on Form 10-Q for the quarter ended June
30, 2015, each filed with the Securities and Exchange Commission,
as well as other information the Company files with the SEC.
We caution investors not to place considerable reliance on
the forward-looking statements contained in this press
release. You are encouraged to read our filings with the SEC,
available at www.sec.gov, for a discussion of these and other
risks and uncertainties. The forward-looking statements in
this press release speak only as of the date of this release and
the Company undertakes no obligation to update or revise any of
these statements. Our business is subject to substantial
risks and uncertainties, including those referenced above.
Investors, potential investors, and others should give careful
consideration to these risks and uncertainties.
Abiomed, Inc. and Subsidiaries |
Consolidated Balance Sheets |
(Unaudited) |
(in thousands, except share
data) |
|
|
|
|
|
|
|
September 30,
2015 |
|
March 31, 2015 |
|
|
|
|
|
ASSETS |
|
|
|
|
Current
assets: |
|
|
|
|
Cash and
cash equivalents |
$ |
54,421 |
|
|
$ |
22,401 |
|
Short-term
marketable securities |
|
121,087 |
|
|
|
109,557 |
|
Accounts
receivable, net |
|
37,119 |
|
|
|
31,828 |
|
Inventories |
|
23,032 |
|
|
|
16,774 |
|
Prepaid
expenses and other current assets |
|
4,030 |
|
|
|
4,479 |
|
Deferred
tax assets, net |
|
25,715 |
|
|
|
35,100 |
|
Total
current assets |
|
265,404 |
|
|
|
220,139 |
|
Long-term
marketable securities |
- |
|
|
13,996 |
|
Property
and equipment, net |
|
11,420 |
|
|
|
9,127 |
|
Goodwill |
|
|
32,676 |
|
|
|
31,534 |
|
In-process
research and development |
|
15,243 |
|
|
|
14,711 |
|
Long-term
deferred tax assets, net |
|
44,240 |
|
|
|
45,206 |
|
Other
assets |
|
4,423 |
|
|
|
3,654 |
|
Total
assets |
$ |
373,406 |
|
|
$ |
338,367 |
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
Current
liabilities: |
|
|
|
Accounts
payable |
$ |
8,788 |
|
|
$ |
10,389 |
|
Accrued
expenses |
|
18,861 |
|
|
|
21,894 |
|
Deferred
revenue |
|
6,803 |
|
|
|
7,036 |
|
Total
current liabilities |
|
34,452 |
|
|
|
39,319 |
|
Other
long-term liabilities |
|
217 |
|
|
|
183 |
|
Contingent
consideration |
|
6,817 |
|
|
|
6,510 |
|
Long-term
deferred tax liabilities |
|
824 |
|
|
|
795 |
|
Total
liabilities |
|
42,310 |
|
|
|
46,807 |
|
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 |
|
424 |
|
|
|
413 |
|
Authorized
- 100,000,000 shares; Issued - 43,756,550 shares at September 30,
2015
and 42,618,717 shares at March 31, 2015; |
|
|
|
|
Outstanding
- 42,417,469 shares at September 30, 2015 and 41,335,773
shares at March 31, 2015 |
|
|
|
|
Additional
paid in capital |
|
489,463 |
|
|
|
465,046 |
|
Accumulated
deficit |
|
(120,628 |
) |
|
|
(137,222 |
) |
Treasury
stock at cost - 1,339,081 shares at September 30, 2015 and
1,282,944
shares at March 31, 2015 |
|
|
(23,157 |
) |
|
|
(19,347 |
) |
Accumulated
other comprehensive loss |
|
(15,006 |
) |
|
|
(17,330 |
) |
Total
stockholders' equity |
|
331,096 |
|
|
|
291,560 |
|
Total
liabilities and stockholders' equity |
$ |
373,406 |
|
|
$ |
338,367 |
|
Abiomed, Inc. and Subsidiaries |
Consolidated Statements of
Operations |
(Unaudited) |
(in thousands, except share
data) |
|
|
|
For the Three Months Ended
September 30, |
|
For the Six Months
Ended
September 30, |
|
|
2015 |
|
2014 |
|
2015 |
|
2014 |
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
Product
revenue |
$ |
76,354 |
|
$ |
|
51,774 |
|
|
$ |
149,780 |
|
$ |
|
100,434 |
|
Funded
research and development |
|
5 |
|
|
|
164 |
|
|
|
11 |
|
|
|
315 |
|
|
|
|
76,359 |
|
|
|
51,938 |
|
|
|
149,791 |
|
|
|
100,749 |
|
Costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Cost of
product revenue |
12,144 |
|
|
|
9,612 |
|
|
|
23,012 |
|
|
|
19,301 |
|
Research
and development |
11,569 |
|
|
|
8,693 |
|
|
|
21,779 |
|
|
|
17,755 |
|
Selling,
general and administrative |
|
39,829 |
|
|
|
29,455 |
|
|
|
77,152 |
|
|
|
61,053 |
|
|
|
|
63,542 |
|
|
|
47,760 |
|
|
|
121,943 |
|
|
|
98,109 |
|
Income from
operations |
|
12,817 |
|
|
|
4,178 |
|
|
|
27,848 |
|
|
|
2,640 |
|
Other
income (loss): |
|
|
|
|
|
|
|
|
|
|
|
Investment
income, net |
62 |
|
|
|
36 |
|
|
|
125 |
|
|
|
80 |
|
Other
income (loss), net |
|
87 |
|
|
|
(39 |
) |
|
|
140 |
|
|
|
(28 |
) |
|
|
|
149 |
|
|
|
(3 |
) |
|
|
265 |
|
|
|
52 |
|
Income
before income taxes |
12,966 |
|
|
|
4,175 |
|
|
|
28,113 |
|
|
|
2,692 |
|
Income tax
provision |
|
5,231 |
|
|
|
336 |
|
|
|
11,519 |
|
|
|
562 |
|
Net
income |
$ |
7,735 |
|
$ |
|
3,839 |
|
|
$ |
16,594 |
|
$ |
|
2,130 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net
income per share |
$ |
0.18 |
|
$ |
|
0.09 |
|
|
$ |
0.40 |
|
$ |
|
0.05 |
|
Basic
weighted average shares outstanding |
42,228 |
|
|
|
40,448 |
|
|
|
41,963 |
|
|
|
40,256 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net
income per share |
$ |
0.17 |
|
$ |
|
0.09 |
|
|
$ |
0.37 |
|
$ |
|
0.05 |
|
Diluted
weighted average shares outstanding |
44,922 |
|
|
|
42,239 |
|
|
|
44,778 |
|
|
|
42,069 |
|
For further information please contact:
Ingrid Goldberg,
Director, Investor Relations
978-646-1590
ir@abiomed.com
Aimee Genzler
Director, Corporate Communications
978-646-1553
agenzler@abiomed.com
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Abiomed via Globenewswire
HUG#1962341
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