Abiomed, Inc. (NASDAQ: ABMD), a
leading provider of breakthrough heart recovery and support
technologies, today reported first quarter fiscal 2020 revenue of
$207.7 million, an increase of 15.4% compared to revenue of $180.0
million for the same period of fiscal 2019. Operating income was
$60.7 million, up 30%, compared to $46.7 million in the same period
of fiscal 2019.
“In Q1, we implemented new training programs, organizational
changes in distribution, and launched external initiatives that
will require time to drive more growth in the future,” said Abiomed
Chairman, President and CEO, Michael R. Minogue. “We are confident
in our ultimate global adoption because we know that our innovation
improves clinical outcomes and patient quality of life.”
Financial and operating highlights for the first quarter fiscal
2020 include:
- Worldwide Impella® heart pump revenue totaled $199.9 million,
an increase of 15% compared to revenue of $173.7 million during the
same period of fiscal 2019.
- U.S. Impella product revenue totaled $168.3 million, an
increase of 11% compared to revenue of $151.7 million during the
same period of fiscal 2019 with U.S. patient usage of the Impella
heart pumps up 13%.
- Outside the U.S., Impella product revenue totaled $31.5
million, an increase of 44% compared to revenue of $21.9 million
during the same period of fiscal 2019. Specifically, Japan revenue
was $8.5 million in the quarter, up 227% compared to the same
period of the prior fiscal year. Also in Japan, the company
announces PMDA approval for Impella Connect and the first Japanese
patient treated with the Impella CP®.
- Gross margin was 82.1% compared to 82.9% during the same period
of fiscal 2019.
- Operating income was $60.7 million, or 29.2% operating margin
compared to $46.7 million, or 26.0% operating margin in the same
period of fiscal 2019.
- GAAP net income was $88.9 million, or $1.93 per diluted share,
which includes a $30.0 million, or $0.65 per share, unrealized gain
from our investment in Shockwave. The company also benefited from
$12.8 million, or $0.28 per share, of excess tax benefits related
to employee share-based compensation awards recorded as a reduction
of income tax expense. This compared to GAAP net income of $90.1
million or $1.95 per diluted share for the prior fiscal year, which
benefited from $53.8 million, or $1.17 per share, of excess tax
benefits.
- The company generated operating cash flow of $64.6 million. As
of June 30, 2019, the company had $526.7 million of cash and
marketable securities and no debt.
- On May 13, the company received U.S. FDA approval for Impella
5.0 and Impella LD extended duration of use from 6 days to 14 days
for cardiogenic shock derived from acute myocardial infarction
(AMI) or cardiomyopathy.
- On May 16, the company announced the launch of the Impella CP
with SmartAssist at the 2019 Society for Cardiovascular Angiography
& Interventions (SCAI) Scientific Sessions. The Impella CP with
SmartAssist is designed to improve patient outcomes with advanced
algorithms and simplified patient management. The majority of
Impella CP heart pumps in the U.S. will be transitioned to
SmartAssist over the next fiscal year.
- Also at SCAI, the society released an online and interactive
training manual with videos and illustrations on access and closure
techniques and best practices. This content is authored by two
leading interventional cardiologists, has been endorsed by SCAI and
resides on the SCAI website at:
http://www.scai.org/vascular-access-and-closure.
- On May 21, the U.S. FDA sent a letter to healthcare providers
validating that the Impella RP heart pump is safe and effective for
treatment of right heart failure. The data showed a 64% survival
rate and 90% heart recovery for the subgroup of post-approval study
patients who met the enrollment criteria of Impella RP’s premarket
clinical studies. The letter reiterated that the Impella RP heart
pump is the only right-sided device with FDA approval.
- On May 21, investigators published in Catheterization and
Cardiovascular Interventions (CCI) and presented at the 2019 SCAI
Scientific Sessions, updated clinical data from the National
Cardiogenic Shock Initiative Study (NCSI). The study showed 171
consecutive AMI cardiogenic shock (AMICS) patients from 35 sites
demonstrated 72% survival with 98% native heart recovery at
discharge. This compares to the 50% mortality rate that cardiogenic
shock patients have experienced for the last 20 years without
Impella. The patients were treated with the NCSI protocol, which
includes placing the Impella heart pump before revascularization.
The study demonstrates the protocol-based approach to increasing
survival rates in cardiogenic shock is reproducible in academic and
community hospitals across the United States.
- Today, the company announces a new study, published in
Catheterization and Cardiovascular Intervention (CCI),
demonstrating lower incidence of AKI during high risk PCI versus
expected risk models.
- Today, the company announces that the Board of Directors has
authorized the repurchase of up to $200 million of the company’s
common stock. Under the repurchase program, the company is
authorized to repurchase shares through open market purchases,
privately-negotiated transactions or otherwise in accordance with
applicable federal securities laws, including through Rule 10b5-1
trading plans and under Rule 10b-18 of the Securities Exchange Act
of 1934. The repurchase program has no time limit and may be
suspended for periods or discontinued at any time.
FISCAL YEAR 2020 OUTLOOK
The company is revising its fiscal year 2020 guidance for total
revenues to be in the range of $885 million to $925 million, an
increase of 15% to 20% over the prior year. The company is also
revising its fiscal year 2020 guidance for GAAP operating margin to
be in the range of 28% to 30%.
EARNINGS CONFERENCE CALL DETAILS
The company will host a conference call to discuss the results
at 8:00 a.m. EST on Thursday, August 1, 2019. The conference call
releasing full quarterly results will be hosted by Michael R.
Minogue, Chairman, President and Chief Executive Officer and Todd
A. Trapp, Vice President and Chief Financial Officer.
To listen to the call live, please tune into the webcast via
https://edge.media-server.com/mmc/p/yatfouke or dial (855)
212-2361; the international number is (678) 809-1538. A replay of
this conference call will be available beginning at 11:00 a.m. EST
August 1, 2019 through 11:00 a.m. EST on August 8, 2019. The replay
phone number is (855) 859-2056; the international number is (404)
537-3406. The replay access code is 9696367.
ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, 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.
Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella
CP, Impella RP, and Impella Connect are registered trademarks of
Abiomed, Inc., and are registered in the U.S. and certain foreign
countries. Impella BTR, Impella 5.5, Impella ECP, CVAD Study, and
SmartAssist are pending trademarks of Abiomed, Inc.
FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, including,
without limitation, statements regarding development of Abiomed's
existing and new products, the company's progress toward commercial
growth, and future opportunities and expected regulatory approvals.
All statements, other than statements of historical facts, may be
forward-looking statements. These forward-looking statements may be
accompanied by such words as “anticipate,” “believe,” “estimate,”
“expect,” “forecast,” “intend,” “may,” “plan,” “potential,”
“project,” “target,” “should,” “likely,” “will” and other words and
terms of similar meaning. The company's actual results may differ
materially from those anticipated in these forward-looking
statements based upon a number of factors, including, without
limitation: the company’s dependence on Impella® products for all
of its revenues; the company’s ability to successfully compete
against its existing or potential competitors; the acceptance of
the company’s products by cardiac surgeons and interventional
cardiologists; long sales and training cycles associated with
expansion into new hospital cardiac centers; reduced market
acceptance of the company’s products due to lengthy clinician
training process; the company’s ability to effectively manage its
growth; the company’s ability to successfully commercialize its
products; the company’s ability to obtain regulatory approvals and
market and sell its products in certain jurisdictions; enforcement
actions and product liability suits relating to off-label uses of
the company’s products; unsuccessful clinical trials or procedures
relating to products under development; the company’s ability to
maintain compliance with regulatory requirements; the failure of
third-party payers to provide reimbursement of the company’s
products; the company’s ability to increase manufacturing capacity
to support continued demand for its products; the company or its
vendors’ failure to achieve and maintain high manufacturing
standards; the failure of the company’s suppliers to provide the
components the company requires; the company’s ability to expand
its direct sales activities into international markets; and other
risks and challenges detailed in the company's filings with the
Securities and Exchange Commission (the “SEC”), including the most
recently filed Annual Report on Form 10-K and the filings
subsequently filed with or furnished to the SEC. Readers are
cautioned not to place undue reliance on any forward-looking
statements, which speak only as of the date of this release. Unless
otherwise required by law, 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 Consolidated
Balance Sheets (Unaudited) (in thousands, except
share data) June 30, 2019 March 31,
2019 ASSETS Current assets: Cash and cash equivalents
$
101,048
$
121,021
Short-term marketable securities
385,624
370,677
Accounts receivable, net
86,206
90,809
Inventories
87,726
80,942
Prepaid expenses and other current assets
16,761
13,748
Total current assets
677,365
677,197
Long-term marketable securities
40,032
21,718
Property and equipment, net
151,654
145,005
Goodwill
33,035
32,601
In-process research and development
15,411
15,208
Long-term deferred tax assets, net
66,743
77,502
Other assets
140,820
85,115
Total assets
$
1,125,060
$
1,054,346
LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities:
Accounts payable
$
29,688
$
32,185
Accrued expenses
51,941
57,420
Deferred revenues
16,193
16,393
Other current liabilities
2,379
— Total current liabilities
100,201
105,998
Contingent consideration
9,931
9,575
Long-term deferred tax liabilities
833
822
Other long-term liabilities
11,502
1,061
Total liabilities
122,467
117,456
Stockholders' equity: Class B Preferred Stock, $.01 par
value
—
— Authorized - 1,000,000 shares; Issued and outstanding - none
Common stock, $.01 par value
454
451
Authorized - 100,000,000 shares; Issued - 47,435,945 shares at June
30, 2019and 47,026,226 shares at March 31, 2019 Outstanding -
45,374,278 shares at June 30, 2019 and 45,122,985 sharesat March
31, 2019 Additional paid in capital
704,884
690,507
Retained earnings
488,396
399,473
Treasury stock at cost - 2,061,667 shares at June 30, 2019 and
1,903,241 shares atMarch 31, 2019
(179,386
)
(138,852
)
Accumulated other comprehensive loss
(11,755
)
(14,689
)
Total stockholders' equity
1,002,593
936,890
Total liabilities and stockholders' equity
$
1,125,060
$
1,054,346
Abiomed, Inc. and
Subsidiaries Consolidated Statements of Operations
(Unaudited) (in thousands, except per share data)
For the Three Months Ended June 30,
2019
2018
Revenue
$
207,666
$
180,010
Costs and expenses: Cost of revenue
37,073
30,850
Research and development
23,790
21,273
Selling, general and administrative
86,078
81,139
146,941
133,262
Income from operations
60,725
46,748
Other income: Investment income, net
3,049
1,551
Other income, net
39,364
188
42,413
1,739
Income before income taxes
103,138
48,487
Income tax provision (benefit)
14,215
(41,579
)
Net income (A)
$
88,923
$
90,066
Basic net income per share
$
1.97
$
2.02
Basic weighted average shares outstanding
45,215
44,546
Diluted net income per share (B)
$
1.93
$
1.95
Diluted weighted average shares outstanding
46,092
46,169
(A) Net income includes the effect of the following items:
Excess tax benefits related to stock-based compensation awards (1)
$
(12,821
)
$
(53,837
)
Unrealized gain on investment in Shockwave Medical - net of tax (2)
(29,998
)
—
$
(42,819
)
$
(53,837
)
(B) Diluted net income per share includes the effect of the
following items: Excess tax benefits related to stock-based
compensation awards (1)
$
(0.28
)
$
(1.17
)
Unrealized gain on investment in Shockwave Medical - net of tax (2)
(0.65
)
—
$
(0.93
)
$
(1.17
)
(1) Amount represents the impact of excess tax benefits and
shortfalls associated with stock-based awards in each respective
period presented.
(2) In the first quarter of fiscal 2020, the company recorded an
unrealized gain on its investment in Shockwave Medical of $39.6
million ($30.0 million, net of tax provision) and is recorded
within other income, net.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190801005302/en/
Ingrid Goldberg Director, Investor Relations 978-646-1590
ir@abiomed.com
Tom Langford Director, Communications & Public Relations
978-882-8408 tlangford@abiomed.com
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