Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough
heart recovery and support technologies, today reported third
quarter fiscal 2020 revenue of $221.6 million, an increase of 10%
compared to revenue of $200.6 million for the same period of fiscal
2019. Operating income was $70.3 million, up 13%, compared to $62.4
million in the same period of fiscal 2019.
Financial and operating highlights for the third quarter fiscal
2020 include:
- U.S. revenue totaled $185.6 million, an increase of 8% compared
to revenue of $172.6 million during the same period of fiscal 2019
with U.S. patient usage of Impella heart pumps up 5%.
- Abiomed had a strong start to the quarter across all
geographies, highlighted by 24% global revenue growth and 16%
growth in U.S. patient usage in October. The company was negatively
impacted at a conference by two misleading presentations from
observational databases representing less than 4% of our patients
over the time period and excluded patients requiring escalation on
IABP and all ECMO patients. These conclusions conflict with
scientific protocols for observational databases and Impella
outcomes reported in more robust, previously published,
FDA-audited, peer-reviewed, real-world studies and randomized
controlled trials. The totality of the Impella clinical data with 7
FDA studies, 5 post-approval studies and numerous
physician-initiated studies demonstrates Impella is safe and
effective for high-risk PCI, cardiogenic shock, and right heart
failure. The response is detailed in our press release and video
publication review.
- Outside the U.S., revenue totaled $36.0 million, an increase of
29% compared to revenue of $28.0 million during the same period of
fiscal 2019. Specifically, Japan revenue was $8.7 million in the
quarter, up 61% compared to the same period of fiscal 2019.
- Gross margin was 82.0% compared to 83.0% during the same period
of fiscal 2019.
- Operating income was $70.3 million, or 31.7% operating margin
compared to $62.4 million, or 31.1% operating margin in the same
period of fiscal 2019.
- GAAP net income was $69.2 million, or $1.51 per diluted share,
which includes a $17.8 million, or $0.39 per share, unrealized gain
from our investment in Shockwave. This compares to GAAP net income
of $44.9 million or $0.97 per diluted share for the prior fiscal
year.
- The company generated operating cash flow of $89.4 million in
the third quarter and $228.3 million year to date, an increase of
26.0% versus prior year. As of December 31, 2019, the company had
$595.5 million of cash and marketable securities and maintains no
debt.
- On October 31, the company announced the first U.S. patients
treated with Impella 5.5 with SmartAssist. Designed for heart
surgeons, Impella 5.5 with SmartAssist is the first and only
forward flow heart pump designed for axillary implant with a
smaller profile, weaning algorithms and gives patients the ability
to ambulate which has been shown to improve outcomes. The Impella
5.5 with SmartAssist is being introduced in the U.S. through a
controlled rollout at hospitals with established heart recovery
protocols.
- On November 14, the company announced a comprehensive
publication review of cost and comparative effectiveness of Impella
in high-risk PCI and cardiogenic shock. The data, from a robust
body of US and European evidence from 2004 - 2019, includes the
PROTECT II FDA randomized controlled trial, data from the Centers
for Medicare & Medicaid Services MedPAR database and more than
20 peer-reviewed clinical publications on cost-effectiveness. It
demonstrates that Impella use in high-risk PCI (Protected PCI) and
cardiogenic shock, when compared to intra-aortic balloon pump
(IABP) or other therapies, is associated with improved patient
outcomes and reduced costs.
- On December 16, the company announced the initiation of the
ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU)
Pivotal Randomized Controlled Trial (RCT), which will explore
whether unloading the heart’s left ventricle for 30 minutes with an
Impella heart pump prior to opening blocked arteries will reduce
infarct size after a heart attack and lead to a reduction in future
heart failure rates. Abiomed announces today 12 patients have been
enrolled and 10 of the 60 hospitals have IRB approval. If the STEMI
DTU trial is successful, it could annually benefit 200,000 heart
attack patients in the United States and more than 4 million
patients outside the United States.
- On January 13, the company presented at the 38th Annual J.P.
Morgan Healthcare Conference. A webcast of the presentation with
automatic slide advance and animations is available on the investor
section of our website.
“Abiomed remains steadfast on our goal of creating the new field
of heart recovery and becoming the standard of care for circulatory
support for high-risk PCI and cardiogenic shock,” said Abiomed
Chairman, President and CEO, Michael R. Minogue. “Today, we are
announcing the start of the next wave of clinical studies designed
by the true experts in the field with best practice protocols
derived from 15 years of clinical experience and studies. In the
history of the company, I feel most confident now about the
strength of our innovation, clinical outcomes with protocols, and
field team. We will remember this time and recognize the
opportunity to propel us forward on our path for CLASS I guidelines
for percutaneous unloading heart pumps called Impella.”
FISCAL YEAR 2020 OUTLOOK
As previously announced in January, the company revised its 2020
revenue guidance to be in the range of $846 million to $877
million, an increase of 10% to 14%, respectively. The company
maintains its fiscal year 2020 guidance for GAAP operating margin
within 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, February 6, 2020. 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/v667km57 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
February 6, 2020 through 11:00 a.m. EST on February 13, 2020. The
replay phone number is (855) 859-2056; the international number is
(404) 537-3406. The replay access code is 8974195.
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, Impella 5.5, Impella Connect, and SmartAssist are registered
trademarks of Abiomed, Inc., and are registered in the U.S. and
certain foreign countries. Impella BTR, Impella ECP, CVAD Study,
and Automated Impella Controller 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; the outcome
of ongoing securities class action litigation relating to our
public disclosures 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) December 31, 2019 March 31, 2019
ASSETS Current assets: Cash and cash equivalents
$
117,970
$
121,021
Short-term marketable securities
309,569
370,677
Accounts receivable, net
100,994
90,809
Inventories
91,193
80,942
Prepaid expenses and other current assets
16,850
13,748
Total current assets
636,576
677,197
Long-term marketable securities
167,981
21,718
Property and equipment, net
162,060
145,005
Goodwill
32,594
32,601
In-process research and development
15,205
15,208
Long-term deferred tax assets, net
47,028
77,502
Other assets
135,167
85,115
Total assets
$
1,196,611
$
1,054,346
LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities:
Accounts payable
$
31,566
$
32,185
Accrued expenses
71,876
57,420
Deferred revenues
19,156
16,393
Other current liabilities
3,661
—
Total current liabilities
126,259
105,998
Contingent consideration
10,440
9,575
Long-term deferred tax liabilities
822
822
Other long-term liabilities
12,227
1,061
149,748
117,456
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
451
451
Authorized - 100,000,000 shares; Issued - 47,498,385 shares at
December 31, 2019 and 47,026,226 shares at March 31, 2019
Outstanding - 45,112,835 shares at December 31, 2019 and 45,122,985
shares at March 31, 2019 Additional paid in capital
733,054
690,507
Retained earnings
570,683
399,473
Treasury stock at cost - 2,385,550 shares at December 31, 2019 and
1,903,241 shares at March 31, 2019
(240,330
)
(138,852
)
Accumulated other comprehensive loss
(16,995
)
(14,689
)
Total stockholders' equity
1,046,863
936,890
Total liabilities and stockholders' equity
$
1,196,611
$
1,054,346
Abiomed, Inc. and Subsidiaries Consolidated Statements of
Operations (Unaudited) (in thousands, except per
share data) For the Three Months Ended
December 31, For the Nine Months Ended December 31,
2019
2018
2019
2018
Revenue
$
221,584
$
200,563
$
634,225
$
562,351
Costs and expenses: Cost of revenue
39,996
34,023
111,937
94,718
Research and development
25,655
23,965
73,413
67,955
Selling, general and administrative
85,674
80,220
257,708
240,254
151,325
138,208
443,058
402,927
Income from operations
70,259
62,355
191,167
159,424
Other income (expenses): Investment income, net
3,086
2,175
9,066
5,397
Other income (expense), net
23,671
(20
)
17,279
10
26,757
2,155
26,345
5,407
Income before income taxes
97,016
64,510
217,512
164,831
Income tax provision (benefit)
27,799
19,648
46,301
(20,225
)
Net income (A)
$
69,217
$
44,862
$
171,211
$
185,056
Basic net income per share
$
1.53
$
1.00
$
3.79
$
4.13
Basic weighted average shares outstanding
45,140
45,046
45,225
44,852
Diluted net income per share (B)
$
1.51
$
0.97
$
3.73
$
4.01
Diluted weighted average shares outstanding
45,695
46,136
45,935
46,147
(A) Net income includes the following items: Excess tax
benefits related to stock-based compensation awards (1)
$
(485
)
$
(1,704
)
$
(13,775
)
$
(68,469
)
Unrealized gain on investment in Shockwave Medical (2)
(17,775
)
—
(13,272
)
—
$
(18,260
)
$
(1,704
)
$
(27,047
)
$
(68,469
)
(B) Diluted net income per share includes the following items:
Excess tax benefits related to stock-based compensation awards (1)
$
(0.01
)
$
(0.04
)
$
(0.30
)
$
(1.48
)
Unrealized gain on investment in Shockwave Medical (2)
(0.39
)
—
(0.29
)
—
$
(0.40
)
$
(0.04
)
$
(0.59
)
$
(1.48
)
(1) Amount represents the impact of excess tax
benefits associated with stock-based awards in each respective
period presented.(2) In the third quarter of fiscal 2020, the
company recorded an unrealized gain on its investment in Shockwave
Medical of $23.5 million ($17.8 million, net of tax benefit) and is
recorded within other income (expense), net.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200206005270/en/
Todd Trapp Vice President and Chief Financial Officer
978-646-1680 ttrapp@abiomed.com Tom Langford Director,
Communications & Public Relations 978-882-8408
tlangford@abiomed.com
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