FY 2019 Annual Revenue of $769 Million, Up 30%,
and 29.2% Operating Margin
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.
EDT May 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 EndedMarch
31,
Fiscal Years EndedMarch
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/
Ingrid GoldbergDirector, Investor
Relations978-646-1590ir@abiomed.com
Tom LangfordDirector, Communications & Public
Relations978-882-8408tlangford@abiomed.com
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