TIDMLMT
RNS Number : 1345X
Lombard Medical Technologies PLC
08 January 2014
Lombard Medical Technologies PLC
("Lombard Medical" or "the Company")
Pre-Close Trading and Strategic Update
Global Aorfix(TM) 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
Aorfix(TM) 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
40(th) 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
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