LONDON, UK--(Marketwired - Jan 8, 2014) -
Lombard Medical Technologies PLC
("Lombard Medical" or "the Company")
Pre-Close Trading and Strategic Update
Global AorfixTM growth; US rollout progressing well
Intention to pursue a US IPO and NASDAQ listing of ordinary shares
London, UK and Irvine, CA, 8 January, 2014 - Lombard Medical
Technologies PLC (AIM : LMT ), the specialist medical device company
focused on Endovascular Aortic Repair ("EVAR") of abdominal aortic
aneurysms ("AAAs"), announced today a pre-close trading update for the
financial year ended 31 December 2013 as well as a strategic update.
All figures are unaudited.
Trading Update
AorfixTM commercial revenue grew 25% to GBP3.9m with revenue from the
main EU markets growing 9%. Revenue from the Rest of World ("ROW")
markets grew 28% and the US contributed to fourth quarter Aorfix
commercial revenue growth of 38% following formal launch in November.
In Europe, the Company experienced strong demand and revenue growth in
Germany and Spain. Following consolidation of EVAR centers in the UK,
which negatively impacted UK revenue in the first half of 2013, second
half 2013 Aorfix revenue in the UK recovered and was flat compared to
the same period the previous year. Total Company revenue grew by 14% to
GBP4.5m, reflecting a decline in revenue of the recently divested OEM
business in Scotland which fell by 27% compared to last year. As
previously announced, this business was divested on 20 December 2013.
Aorfix was approved by the United States Food and Drug Administration
("US FDA") in February 2013 with a unique label indication for the
treatment of patients with angulations at the neck of the aneurysm up
to and including 90 degrees. The product was formally launched in the
US, the largest EVAR market, at the 40th Annual VEITH Symposium, in New
York in November. While Aorfix is still in the initial phase of the US
launch, the product rollout is progressing well, with the number of US
physicians trained to use the device standing at 244 at the year end.
As previously disclosed, the Company's 20-person sales team is
targeting around 300 high volume EVAR centers that perform more than
half of the EVAR procedures in the US.
In Japan, the Company now anticipates regulatory approval for Aorfix
during 2014. Our exclusive Japanese marketing partner, Medico's
Hirata, remains in dialogue with the Pharmaceuticals and Medical
Devices Agency (PMDA) to achieve this. Medico's Hirata is a leading
supplier of medical device products in Japan, with the sales
infrastructure to realize the potential of Aorfix in this growing
market, which in 2013 was estimated to account for approximately $140m
or 10% of the global EVAR market.
As previously announced, the Company is expanding its manufacturing
facility in Didcot, Oxfordshire, to support increasing global demand
for Aorfix. The expansion, which involves the construction of a new
cleanroom and materials handling space, will add around 10,000 sq. ft.
to the existing facility. The expansion project is expected to be
completed by the end of the first quarter of 2014.
The global AAA market for EVAR devices is estimated to be approximately
$1.4bn. The US market is estimated to be worth around half of the
global market and is expected to grow at a compound annual growth rate
in excess of 7% over the next 5 years, driven largely by the growth of
the ageing population and patient screening programs. In addition,
introduction of new technologies such as Aorfix, which allow more
patients to received endovascular treatment of AAA disease, could
potentially further expand the market.
The Company closed 2013 with cash of GBP24.8m and debt of GBP1.5m on its
balance sheet.
NASDAQ IPO
As announced today in a separate press release, the Company intends to
submit a registration statement to the US Securities and Exchange
Commission ("SEC") relating to a proposed US initial public offering of
ordinary shares and a listing on NASDAQ ("NASDAQ IPO").
To facilitate the NASDAQ IPO, a new Cayman Islands holding company will
be created and existing shares in Lombard Medical will be exchanged for
new shares in that holding company ("Share Exchange")
Commencement of the initial public offering is conditional upon
completion of the SEC review process with respect to the registration
statement and is subject to market conditions and other
considerations. In connection with the NASDAQ IPO, Lombard Medical
will also delist its ordinary shares from AIM, a market of the London
Stock Exchange.
In the Share Exchange, existing shareholders will receive shares in the
new Cayman Islands holding company in exchange for the shares they hold
in Lombard Medical. These new shares will not be admitted to trading on
AIM. Shareholders will need to consider their ability to hold and trade
NASDAQ listed shares following the Share Exchange and the AIM
delisting. Full details of the proposals will be set out in a circular
to shareholders in due course.
Lombard Medical intends to use proceeds from the NASDAQ IPO to
accelerate its commercialization strategy for Aorfix in the US with a
particular focus on continuing to expand its direct sales force to
accelerate penetration of the US AAA market. The Company will also
continue to invest in developing new products to treat complex vascular
disease, including a stent graft to treat aneurysms in the thoracic
aorta.
This press release does not constitute an offer of any securities for
sale.
-Ends-
For further information:
Lombard Medical Technologies PLC Tel: +44 (0)1235 750 800
Simon Hubbert, Chief Executive Officer
Ian Ardill, Chief Financial Officer
Canaccord Genuity Limited Tel: +44 (0)20 7523 8000
Lucy Tilley / Tim Redfern /
Henry Fitzgerald O'Connor / Dr Julian Feneley
FTI Consulting (UK) Tel: +44 (0)20 7831 3113
Simon Conway / Stephanie Cuthbert /
Victoria Foster Mitchell
Allen & Caron (US) Tel: +1 (949) 474 4300
Matt Clawson
About Abdominal Aortic Aneurysms
AAAs are a balloon-like enlargement of the aorta which, if left
untreated, may rupture and cause death. Approximately 4.5 million
people are living with AAAs in the developed world and each year over
500,000 new cases are diagnosed. In the US, aortic aneurysm disease is
among the leading causes of death and it is estimated that 1.7 million
people over the age of 55 have an abdominal aortic aneurysm.
About Lombard Medical
Lombard Medical Technologies PLC (AIM : LMT ) is a medical device company
focused on device solutions for the $1.4 billion per annum abdominal
aortic aneurysm ("AAA") 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. Aorfix is the
only stent graft approved for AAA neck angulations of up to 90 degrees
and is currently being commercialized worldwide. Aorfix is the first
AAA stent graft not of US origin to gain US FDA approval. The Company
is headquartered in Oxfordshire, England with US operations in Irvine,
CA.
Further background on the Company can be found at
www.lombardmedical.com .
FORWARD-LOOKING STATEMENTS
This announcement may contain forward-looking statements that reflect
the Company's current expectations regarding future events, including
the commercialization and regulatory clearance of the Company's
products, the Group's liquidity and results of operations, as well as
the Group's 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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
Contact Information:
Contacts:
RNS
Customer
Services
0044-207797-4400
http://www.rns.com