Abiomed, Inc. (NASDAQ: ABMD), a leading provider of breakthrough
heart support technologies today reported preliminary, unaudited,
third quarter fiscal 2020 revenue of approximately $221.6 million,
an increase of 10% compared to revenue of $200.6 million for the
same period of fiscal 2019.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20200113005332/en/
Summary of Safety Data by Devices
(Graphic: Business Wire)
- 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.
- Preliminary unaudited total U.S. revenue grew 8% to $185.6
million from $172.6 million in the prior fiscal year. U.S. patient
usage grew 5% in comparison with the same period of fiscal
2019.
- Outside the U.S., total revenue for the quarter totaled $36.0
million, an increase of 29% compared to revenue of $28.0 million
during the same period of fiscal 2019, due to strength in Germany
and Japan.
- In the quarter, the company was negatively impacted by two
presentations at a conference on November 17, which the company
believes are based on misleading analyses. The company is taking
the following actions:
- Abiomed’s Medical Office completed a review
that determined the presentations are misleading based on older,
non-FDA audited, observational data on less than 4% of our patients
treated over a 10-year period. The response is detailed in our
press release and video publication review issued on November 19.
Abiomed has also initiated processes to increase the publications
of real-world evidence for mechanical circulatory support in the
NCDR database which will include patients that are escalated on an
IABP and ECMO.
- Abiomed has selected physician experts in
the field of circulatory support to create a dedicated faculty for
education and training on PCI and hemodynamic support. These
programs will include a national user meeting, educational programs
with onsite, in-house and online training, physician proctoring,
establishing heart recovery centers of excellence and a password
protected online community for physicians.
- Initiating a multi-city road show in Q4 to
review with physicians Impella’s current clinical data, FDA studies
and best practices that support Impella’s indications for high-risk
PCI, cardiogenic shock and right heart failure.
- Abiomed will also be working with
appropriate societies and hospital systems to communicate the
audited and published results from seven FDA studies, five on-going
FDA post-approval studies, and independent physician-led initiates
such as NCSI, the INOVA heart team approach, and The Shock Working
Group. These studies demonstrate improved outcomes with our best
practices for high-risk PCI, cardiogenic shock and right heart
failure. In addition, published and audited prospective data
reveals lower or comparable event rates for stroke, vascular
complications and major bleeding as compared to IABP and ECMO. The
data is detailed in the accompanying chart.
“Abiomed remains focused on our goal of creating the new field
of heart recovery and becoming the standard of care for circulatory
support. This is an ambitious goal that certainly has challenges
with the diffusion of any new break-through innovation, and we are
taking specific actions to address these challenges. The long-term
outlook for Abiomed remains intact and we are working with
physician experts to clarify and educate the community on Impella
best practice protocols and clinical outcomes,” said Abiomed
Chairman, President and CEO, Michael R. Minogue. “Our product
innovation has never been better with the launch of Impella CP® and
Impella 5.5™ with SmartAssist®. We have our best ever clinical
outcomes with our protocols for high-risk PCI, cardiogenic shock
and right heart failure.”
The preliminary unaudited revenue results described in this
press release are estimates only and are subject to revision until
the company reports its full financial results for the third
quarter of fiscal 2020 on February 6, 2020.
These preliminary results are being provided in advance of the
company's presentation at the 38th Annual J.P. Morgan Healthcare
Conference at the Westin St. Francis Hotel in San Francisco.
Michael R. Minogue, Chairman, President and Chief Executive
Officer, Abiomed, will present on Monday, January 13, 2020 at 12:00
p.m. PST / 3:00 p.m. EST.
A live webcast of the company's presentation at the conference
will be available via the link
https://jpmorgan.metameetings.net/events/hc20. The webcast will
also be available on the investor section of the company's website
at www.abiomed.com. A replay of the webcast will be available for
90 days after the presentation.
FISCAL YEAR 2020 OUTLOOK
The company is updating its fiscal year 2020 revenue guidance to
be in the range of $846 million to $877 million, an increase of 10%
to 14%, respectively.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200113005332/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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