Lombard Medical, Inc. (Nasdaq: EVAR), a medical device company focused
on Endovascular Aortic Repair (EVAR) of abdominal aortic aneurysms
(AAA), today announced summary financial results for the first quarter
ended March 31, 2014.
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Global sales of the Company’s Aorfix™ stent graft for the endovascular
aortic repair of abdominal aortic aneurysms grew 104% to $2.0 million
compared with $1.0 million in the first quarter of 2013.
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In the United States (US), where Aorfix was formally launched in
November 2013, sales grew 72% sequentially to $0.5 million in the
first quarter as compared to $0.3 million in the 2013 fourth
quarter.
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In the main European markets, sales grew 59% to $1.1 million
compared with $0.7 million in the first quarter of 2013, with
growth being driven by UK and Germany sales.
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Sales in the Rest-of-World distributor markets grew 44% to $0.4
million from $0.3 million in the first quarter of 2013.
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Total sales grew 64% to $2.0 million compared with $1.3 million in the
first quarter of 2013. The lower total growth figure reflected the
divestment of the Company’s OEM business in December 2013. Sales from
this business were $0.3 million in the first quarter of 2013.
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Net loss for the first quarter of 2014 was $6.9 million, compared to
$3.0 million in the first quarter of 2013. The increased loss was
principally due to on-going investments in a US-based operation,
commercial infrastructure, direct sales force and training activities.
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Cash and cash equivalents at March 31, 2014 were $33.4 million,
compared to $40.9 million at December 31, 2013. Proceeds from the US
initial public offering (IPO) on April 25, 2014, after expenses will
add approximately $48 million of cash in the second quarter of 2014.
“It’s clear that the 2013 FDA approval for Aorfix is having a positive
effect on our international business, and our launch strategy in the US
is showing early success as physicians begin to appreciate the clinical
benefits of using Aorfix in patients with tortuous AAA anatomy,” said
Simon Hubbert, CEO of Lombard Medical. “We anticipate acceleration in
adoption of Aorfix for the treatment of both highly angulated and less
complex aneurysms as we continue to grow our direct sales teams.”
Aorfix is the only endovascular stent graft cleared by the FDA for the
treatment of AAAs with angulation at the neck of the aneurysm of up to
90 degrees. All other approved grafts are only cleared for the treatment
of anatomies that are less complex (neck angulations of up to 60
degrees).
Hubbert concluded, “We are now well capitalized and in a good position
to complete the build out of our US sales force. Our plan is to more
than double the current number of selling professionals in the US by
year-end."
The Company plans to announce detailed results for its second quarter
ended June 30, 2014, its first full operating quarter as a Nasdaq traded
company, in early August.
About Lombard Medical, Inc.
Lombard Medical, Inc. is a medical device company focused on device
solutions for the $1.4 billion per annum abdominal aortic aneurysm
repair market. The Company’s lead product, Aorfix™, is an endovascular
stent graft which has been specifically designed to solve the problems
that exist in treating complex tortuous anatomy, which is often present
in advanced AAA disease. Lombard Medical, Inc. is based in Oxfordshire,
England with US commercial headquarters in Irvine, CA and is registered
in the Cayman Islands.
FORWARD-LOOKING STATEMENTS:
This announcement may contain forward-looking statements that reflect
the Company’s current expectations regarding future events, including
the commercialization and additional regulatory clearances of the
Company’s products, the Company's liquidity and results of operations,
as well as future capital raising activities. Forward-looking statements
involve risks and uncertainties. Actual events could differ materially
from those projected herein and depend on a number of factors, including
the success of the Company’s research and development and
commercialization strategies, the uncertainties related to the
regulatory process and the acceptance of the Company’s products by
hospitals and other medical professionals and the risks, uncertainties
and other factors described under the heading “Risk Factors” in the
Company’s prospectus filed with the Securities and Exchange Commission
dated April 25, 2014. The Company undertakes no obligation to update
these statements in the future.
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