FY 2019 Annual Revenue of $769 Million, Up 30%, and 29.2% Operating
Margin
DANVERS, Mass.--(BUSINESS WIRE)--May 2, 2019--
Abiomed,
Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart
recovery and support technologies, today reported fourth quarter fiscal
2019 revenue of $207.1 million, an increase of 19% compared to revenue
of $174.4 million for the same period of fiscal 2018. For fiscal year
2019, total revenue was $769.4 million, up 30% compared to revenue of
$593.7 million, and operating income was $224.8 million, up 43% compared
to operating income of $157.1 million in fiscal year 2018.
“Q4 did not meet our expectations. I take full responsibility for our
disappointing performance given a soft March, and we have already
initiated a plan of action to correct the course. However, Abiomed had a
solid year with 30% growth and improvement in margins. Most importantly,
Abiomed’s clinical support, training, and education helped improve
patient outcomes in both high-risk PCI and cardiogenic shock. Multiple
publications continue to validate the benefits of Impella supported PCI
and Impella best practices to help improve survival in cardiogenic
shock,” said Abiomed Chairman, President and CEO, Michael R. Minogue. “I
am confident in our innovation and business today as well as long-term
outlook for Abiomed. We are creating the new Field of Heart Recovery.”
Recent financial and operating highlights include:
-
Worldwide Impella® heart pump revenue for the quarter totaled $199.5
million, an increase of 19% compared to revenue of $168.3 million
during the same period of the prior fiscal year. Full year worldwide
Impella heart pump revenue totaled $741.7 million for fiscal 2019, an
increase of 30% compared to revenue of $570.9 million for the prior
fiscal year.
-
U.S. Impella product revenue for the quarter totaled $169.7 million,
an increase of 16% compared to revenue of $146.2 million during the
same period of the prior fiscal year with U.S. patient usage of the
Impella heart pumps up 14%, driven by lower growth in March. Full year
U.S. Impella revenue totaled $639.3 million, up 27% compared to $505.1
million in the prior fiscal year with U.S. patient usage of the
Impella heart pumps up 23%.
-
Outside the U.S., Impella product revenue for the quarter
totaled $29.8 million, an increase of 35% compared to revenue of $22.1
million during the same period of the prior fiscal year. Full year
Impella product revenue outside the U.S. totaled $102.4 million, an
increase of 56% compared to $65.7 million in the prior fiscal year.
Specifically, Japan revenue was $5.4 million for the quarter and $17.5
million for the year, up 212% and 503%, respectively, compared to
prior fiscal year.
-
Gross margin for the fourth quarter of fiscal 2019 was 83.2% compared
to 82.7% during the same period of fiscal 2018. For the full fiscal
year 2019, gross margin was 83.2% compared to 83.4% in fiscal year
2018.
-
Operating income for the fourth quarter fiscal 2019 was $65.4 million,
or 31.6% operating margin, compared to $47.6 million, or 27.3%
operating margin in the same period of fiscal 2018. For the full
fiscal year 2019, operating income was $224.8 million, or 29.2% of
revenue, compared to $157.1 million, or 26.5% of revenue in the prior
fiscal year.
-
Fourth quarter fiscal 2019 GAAP net income was $74.0 million, or $1.60
per diluted share, an increase of 101%, compared to GAAP net income of
$36.8 million or $0.80 per diluted share for the prior fiscal year.
Full fiscal year 2019 GAAP net income was $259.0 million, or $5.61 per
diluted share, an increase of 131%, compared to $112.2 million, or
$2.45 per diluted share for the prior fiscal year. Fourth quarter and
full year fiscal GAAP net income includes a $23.6 million, or $0.51
per diluted share unrealized gain on our investment in Shockwave
Medical, Inc.
-
The company generated operating cash flow of $72.2 million in the
fourth quarter and $254.0 million for the full fiscal year 2019.
During fiscal 2019, the company deployed $71.8 million of cash to
repurchase shares related to vested equity awards and $42.7 million
for strategic investments in medical device technologies, including
Shockwave Medical, Inc. As of March 31, 2019, the company had $513.4
million of cash and marketable securities and no debt.
-
On January 31, the company earned CE Mark for Impella Connect, the
first-of-its kind cloud-based technology that enables secure,
real-time, remote monitoring of patients on the Impella console for
Abiomed clinical consultants and physicians from anywhere with
internet connectivity.
-
On February 4, the FDA released a letter to health care providers on
the Impella RP heart pump. On March 18, the company presented and
published survival data from the 18-month post-approval study of 42
Impella RP patients at the American College of Cardiology’s (ACC) 68th
Annual Scientific Session in New Orleans and submitted the
post-approval study report to the FDA. The FDA recognizes salvage
patients as those outside the Recover Right protocol (>48 hours in
cardiogenic shock).
-
On March 25, the company received Pharmaceuticals and Medical Devices
Agency (PMDA) approval from the Japanese Ministry of Health, Labour &
Welfare for the Impella CP® heart pump.
-
On April 4, the company announced that cardiogenic shock survival
rates have improved significantly in the three years since the Impella
FDA PMA Approval. New data from the IQ Database on patients treated
between April 2018 and March 2019 showed an increase in median
survival from 51% to 67%, a relative increase of 34% in survival.
Additionally, results published by Dr. Tehrani at Inova Heart and
Vascular Institute in the Journal of the American College of
Cardiology demonstrate that best practice protocols with early use of
percutaneous mechanical circulatory support in AMI cardiogenic shock
increased survival at 30 days from 44% to 82% (p=0.0001).
-
On April 23, the company highlighted clinical data on its exclusive
FDA approval for high-risk PCI and on the advantages of Protected PCI
to enable complete revascularization and improved patient quality of
life. A new study was published in the Journal of Interventional
Cardiology by Dr. Burzotta and found that six months after a Protected
PCI, the number of patients with left ventricular ejection fraction
(LVEF) greater than or equal to 35% increased from 22% to 67%.
-
Today, the company announced in a separate press release that the FDA
approved the initiation of the ST-Elevation Myocardial Infarction
Door-to-Unloading (STEMI DTU) pivotal randomized controlled trial.
FISCAL YEAR 2020 OUTLOOK
The company is giving its fiscal year 2020 guidance for total revenues
to be in the range of $900 million to $945 million, an increase of 17%
to 23% over the prior year. The company is also giving its fiscal year
2020 guidance for GAAP operating margin to be in the range of 29% to
31%. The company plans to give another formal forecast for the fiscal
year on the next earnings call.
EARNINGS CONFERENCE CALL DETAILS
The company will host a conference call to discuss the results at 8 a.m.
EDT on Thursday, May 2, 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/m6/p/sg8hmgr6
or dial (855) 212-2361; the international number is (678) 809-1538. A
replay of this conference call will be available beginning at 12:00 p.m.
EDTMay 2, 2019 through 12:00 p.m. EDT on May 9, 2019. The replay phone
number is (855) 859-2056; the international number is (404) 537-3406.
The replay access code is 2498807.
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.
To learn more about the Impella platform of heart pumps, including their
approved indications and important safety and risk information
associated with the use of the devices, please visit: www.protectedpci.com.
The Abiomed logo, Abiomed, Impella, Impella 2.5, Impella 5.0, Impella
LD, Impella CP, Impella RP, Impella Connect, and Recovering hearts.
Saving lives. are registered trademarks of Abiomed, Inc. in the U.S. and
in certain foreign countries.
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 and related regulatory approvals,
including the unpredictability of future operating results, 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 other risks and challenges detailed in the company's
filings with the Securities and Exchange Commission, including the most
recently filed Annual Report on Form 10-K and 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, Inc. and Subsidiaries |
Consolidated Balance Sheets |
(Unaudited) |
(in thousands, except share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2019 |
|
|
|
March 31, 2018 |
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
$
|
121,021
|
|
|
|
$
|
42,975
|
|
Short-term marketable securities
|
|
|
|
370,677
|
|
|
|
|
319,274
|
|
Accounts receivable, net
|
|
|
|
90,809
|
|
|
|
|
70,010
|
|
Inventories
|
|
|
|
80,942
|
|
|
|
|
50,204
|
|
Prepaid expenses and other current assets
|
|
|
|
13,748
|
|
|
|
|
11,808
|
|
Total current assets
|
|
|
|
677,197
|
|
|
|
|
494,271
|
|
Long-term marketable securities
|
|
|
|
21,718
|
|
|
|
|
37,502
|
|
Property and equipment, net
|
|
|
|
145,005
|
|
|
|
|
117,167
|
|
Goodwill
|
|
|
|
32,601
|
|
|
|
|
35,808
|
|
In-process research and development
|
|
|
|
15,208
|
|
|
|
|
16,705
|
|
Long-term deferred tax assets, net
|
|
|
|
77,502
|
|
|
|
|
70,746
|
|
Other assets
|
|
|
|
85,115
|
|
|
|
|
14,176
|
|
Total assets
|
|
|
$
|
1,054,346
|
|
|
|
$
|
786,375
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
|
$
|
32,185
|
|
|
|
$
|
23,565
|
|
Accrued expenses and other liabilities
|
|
|
|
57,420
|
|
|
|
|
46,147
|
|
Deferred revenue
|
|
|
|
16,393
|
|
|
|
|
14,970
|
|
Total current liabilities
|
|
|
|
105,998
|
|
|
|
|
84,682
|
|
Other long-term liabilities
|
|
|
|
1,061
|
|
|
|
|
776
|
|
Contingent consideration
|
|
|
|
9,575
|
|
|
|
|
10,490
|
|
Long-term deferred tax liabilities
|
|
|
|
822
|
|
|
|
|
903
|
|
Total liabilities
|
|
|
|
117,456
|
|
|
|
|
96,851
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity:
|
|
|
|
|
|
|
|
|
|
|
Class B Preferred Stock, $.01 par value
|
|
|
|
—
|
|
|
|
|
—
|
|
Authorized - 1,000,000 shares; Issued and outstanding - none
|
|
|
|
|
|
|
|
|
|
|
Common stock, $.01 par value
|
|
|
|
451
|
|
|
|
|
444
|
|
Authorized - 100,000,000 shares; Issued - 47,026,226 shares at March
31, 2019 and 46,100,649 shares at March 31, 2018;
|
|
|
|
|
|
|
|
|
|
|
Outstanding - 45,122,985 shares at March 31, 2019 and 44,375,337
shares at March 31, 2018
|
|
|
|
|
|
|
|
|
|
|
Additional paid in capital
|
|
|
|
690,507
|
|
|
|
|
619,905
|
|
Retained earnings (Accumulated deficit)
|
|
|
|
399,473
|
|
|
|
|
140,457
|
|
Treasury stock at cost - 1,903,241 shares at March 31, 2019 and
1,725,312 shares at March 31, 2018
|
|
|
|
(138,852
|
)
|
|
|
|
(67,078
|
)
|
Accumulated other comprehensive income (loss)
|
|
|
|
(14,689
|
)
|
|
|
|
(4,204
|
)
|
Total stockholders' equity
|
|
|
|
936,890
|
|
|
|
|
689,524
|
|
Total liabilities and stockholders' equity
|
|
|
$
|
1,054,346
|
|
|
|
$
|
786,375
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abiomed, Inc. and Subsidiaries |
|
Consolidated Statements of Operations |
|
(Unaudited) |
|
(in thousands, except per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
|
Fiscal Years Ended March 31,
|
|
|
|
|
2019 |
|
|
2018 |
|
|
|
2019 |
|
|
2018 |
|
Revenue
|
|
|
$
|
207,081
|
|
|
$
|
174,436
|
|
|
|
$
|
769,432
|
|
|
$
|
593,749
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue
|
|
|
|
34,848
|
|
|
|
30,098
|
|
|
|
|
129,567
|
|
|
|
98,581
|
|
Research and development
|
|
|
|
25,548
|
|
|
|
21,270
|
|
|
|
|
93,503
|
|
|
|
75,297
|
|
Selling, general and administrative
|
|
|
|
81,296
|
|
|
|
75,501
|
|
|
|
|
321,550
|
|
|
|
262,734
|
|
|
|
|
|
141,692
|
|
|
|
126,869
|
|
|
|
|
544,620
|
|
|
|
436,612
|
|
Income from operations
|
|
|
|
65,389
|
|
|
|
47,567
|
|
|
|
|
224,812
|
|
|
|
157,137
|
|
Other income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment income, net
|
|
|
|
2,769
|
|
|
|
1,303
|
|
|
|
|
8,166
|
|
|
|
3,688
|
|
Other income (expense), net
|
|
|
|
30,372
|
|
|
|
(363
|
)
|
|
|
|
30,382
|
|
|
|
(388
|
)
|
|
|
|
|
33,141
|
|
|
|
940
|
|
|
|
|
38,548
|
|
|
|
3,300
|
|
Income before income taxes
|
|
|
|
98,530
|
|
|
|
48,507
|
|
|
|
|
263,360
|
|
|
|
160,437
|
|
Income tax provision
|
|
|
|
24,569
|
|
|
|
11,660
|
|
|
|
|
4,344
|
|
|
|
48,267
|
|
Net income (A)
|
|
|
$
|
73,961
|
|
|
$
|
36,847
|
|
|
|
$
|
259,016
|
|
|
$
|
112,170
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share
|
|
|
$
|
1.64
|
|
|
$
|
0.83
|
|
|
|
$
|
5.77
|
|
|
$
|
2.54
|
|
Basic weighted average shares outstanding
|
|
|
|
45,091
|
|
|
|
44,320
|
|
|
|
|
44,911
|
|
|
|
44,153
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per share (B)
|
|
|
$
|
1.60
|
|
|
$
|
0.80
|
|
|
|
$
|
5.61
|
|
|
$
|
2.45
|
|
Diluted weighted average shares outstanding
|
|
|
|
46,173
|
|
|
|
46,141
|
|
|
|
|
46,151
|
|
|
|
45,849
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(A) Net income includes the effect of the following items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of the Tax Reform Act on net deferred tax assets (1)
|
|
|
$
|
—
|
|
|
$
|
(593
|
)
|
|
|
$
|
—
|
|
|
$
|
21,364
|
|
Excess tax benefits related to stock-based compensation awards (2)
|
|
|
|
(798
|
)
|
|
|
(6,501
|
)
|
|
|
|
(69,267
|
)
|
|
|
(30,991
|
)
|
Unrealized gain on investment in Shockwave Medical - net of tax (3)
|
|
|
|
(23,636
|
)
|
|
|
—
|
|
|
|
|
(23,636
|
)
|
|
|
—
|
|
|
|
|
$
|
(24,434
|
)
|
|
$
|
(7,094
|
)
|
|
|
$
|
(92,903
|
)
|
|
$
|
(9,627
|
)
|
(B) Diluted net income per share includes the effect of the
following items:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of the Tax Reform Act on net deferred tax assets (1)
|
|
|
$
|
—
|
|
|
$
|
(0.01
|
)
|
|
|
$
|
—
|
|
|
$
|
0.47
|
|
Excess tax benefits related to stock-based compensation awards (2)
|
|
|
|
(0.02
|
)
|
|
|
(0.14
|
)
|
|
|
|
(1.50
|
)
|
|
|
(0.68
|
)
|
Unrealized gain on investment in Shockwave Medical - net of tax (3)
|
|
|
|
(0.51
|
)
|
|
|
—
|
|
|
|
|
(0.51
|
)
|
|
|
—
|
|
|
|
|
$
|
(0.53
|
)
|
|
$
|
(0.15
|
)
|
|
|
$
|
(2.01
|
)
|
|
$
|
(0.21
|
)
|
|
|
(1) On December 22, 2017, the Tax Cut and Jobs Act was enacted into law,
which among other items, reduced the U.S. federal statutory corporate
income tax rate from 35% to 21% effective January 1, 2018. During the
three months and year ended March 31, 2018, the company recorded tax
expense adjustments related to the revaluation of its deferred taxes due
to a reduction of the U.S. federal statutory corporate income tax rate.
(2) Amount represents the impact of excess tax benefits and shortfalls
associated with stock-based awards in each respective period presented.
(3) In the fourth quarter of fiscal 2019, the company recorded an
unrealized gain on its investment in Shockwave Medical of $31.2 million
($23.6 million, net of tax provision) and is recorded within other
income (expense), net.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190502005274/en/
Source: Abiomed, Inc.
Ingrid Goldberg
Director, Investor Relations
978-646-1590
ir@abiomed.com
Tom Langford
Director, Communications & Public Relations
978-882-8408
tlangford@abiomed.com