RNS Number:4749Y
Lombard Medical Technologies PLC
15 June 2007
The following replaces the fundraising announcement released today at 7am under
RNS number 4248Y.
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN THE UNITED STATES, CANADA,
AUSTRALIA, SOUTH AFRICA OR JAPAN
Lombard Medical Technologies PLC
("Lombard" or "Company")
Fundraising of #7.4 million
London, UK, 15 June 2007 - Lombard Medical Technologies PLC (AIM: LMT), the
specialist medical device company, is pleased to announce a fundraising by
Nomura Code Securities Limited and Seven Hills Partners LLC of approximately
#7.4 million (gross). Lombard is also announcing its preliminary results today
(see separate announcement).
Highlights:
* Fundraising by way of a Subscription and a Placing of new Ordinary Shares
to raise gross proceeds of approximately #7.4 million at 25p per share
* Funds to be used to progress the clinical trial of the Aorfix(TM) AAA stent
graft in the United States, scale up manufacturing in order to enable the
Company to meet the forecast demand for Aorfix(TM) in Europe and additional
product development (principally Aorfix(TM) and EndoRefix(TM))
* A Warrant to subscribe for one ordinary share will be issued to
subscribers and placees on the basis of six Warrants for every twenty new
shares
Alistair Taylor, Lombard's Executive Chairman, said:
"I am delighted by the success of this fundraising, which will allow the Company
to achieve significant milestones in the clinical development of our Aorfix(TM)
AAA stent graft in the United States and to scale up manufacturing of Aorfix(TM)
to enable the Company to meet the forecast growing demand for our stent graft in
Europe and the rest of the world. I would like to take this opportunity to
welcome all new investors to the Company, which is now entering the most
exciting period in its development."
Enquiries:
Lombard Medical Technologies PLC
Tel: +44 (0) 1235 750 800
Alistair Taylor, Executive Chairman
Brian Howlett, Chief Executive Officer
Tim Hall, Finance Director
Financial Dynamics
Tel: +44 (0) 20 7831 3113
David Yates / John Gilbert
Nomura Code Securities Limited
Tel: +44 (0) 20 7776 1200
Richard Potts
Seven Hills Partners LLC
Tel: +1 415 869 6234
Kathryn E Coffey
Notes to editors
About Lombard Medical
Lombard Medical Technologies PLC is a medical devices group developing stent
grafts and other medical products for use in the treatment of vascular disease.
The Company's lead product, Aorfix(TM), is a stent graft for the treatment of
aortic aneurysms, a balloon-like enlargement of the aorta which, if untreated,
may rupture and cause death. Abdominal and thoracic aortic aneurysms are the
13th largest cause of death in the US and the market is estimated to be worth
approximately US$2 billion by 2010. Aorfix(TM) is currently being commercialised
in the EU, with US clinical trials having commenced during 2006. The Company's
Polymer Coatings Division primarily develops polymer coatings for use in drug
eluting stents and has a number of research collaborations developing novel
products for this $5-6bn market.
The Company, headquartered in Oxfordshire, with operations in Yorkshire and
Boston, USA, employs over 90 people.
Further background on the Company can be found at www.Lombardmedical.com.
Lombard Medical Technologies PLC
Proposed Placing and Subscription of 29,532,660 new Ordinary Shares
Proposed Issue of Warrants
Introduction
The Board of Lombard Medical Technologies PLC ("Lombard") announces that the
Company is raising approximately #6.6 million, after expenses, by way of a
conditional Placing and Subscription of, in aggregate, 29,532,660 new Ordinary
Shares at an issue price of 25 pence per new Ordinary Share in order to provide
further working capital for the Company. In addition, Warrants to subscribe for,
in aggregate, 8,859,798 Ordinary Shares will be issued to Subscribers and
Placees pursuant to the Subscription and the Placing, respectively. Further
details of the Warrants are set out in the section "Terms of the Warrants"
below.
The Subscribers have agreed, subject to, inter alia, Shareholders' approval, to
subscribe for, in aggregate, 10,532,660 new Ordinary Shares at the Issue Price
together with Subscription Warrants to subscribe for 3,159,798 Ordinary Shares.
The Subscription will raise #2.6 million (gross) for the Company.
In addition to the Subscription, Nomura Code, as agent for the Company, is
placing, subject to Shareholders' approval, 19,000,000 Placing Shares at the
Issue Price with new and existing institutional investors, together with Placing
Warrants to subscribe for 5,700,000 Ordinary Shares. The Placing will raise #4.8
million (gross) for the Company. Nomura Code Securities Limited has underwritten
the Placing.
Progress with the Lombard strategy
2006 was a year of significant challenge and accomplishment for the Company.
Despite having to overcome a series of challenges during the year, considerable
growth has been achieved in the European business. Aorfix(TM) has now been
successfully implanted in over 250 patients in 18 countries and momentum
continues to build in the pivotal US clinical trial. The positive results from
the two-year follow-on data of Aorfix(TM), which showed aneurysm sac shrinkage
in 83% of patients and no evidence of migration or device-related endoleaks,
compared favourably with competitor products.
2006 was also a tough year for the industry generally; two major US companies
temporarily ceased their activities in the AAA stent graft market due to the
limitations of their devices, one of them for the second time. This has
demonstrated the difficulties of succeeding in such a challenging market, even
when significant resources have been dedicated.
During 2006, the Company decided, after discussions with Boston, to continue
with its own distribution of Aorfix(TM) in territories outside of the US as
Boston had decided to close their in-house activities in endovascular AAA
surgery. Despite this, the Company understands that Boston continues to believe
that the market for AAA endovascular surgery will grow significantly over the
next ten years. Boston currently maintains a shareholding of 9% in the Company,
along with a right of first refusal over the Cardiovascular Devices Division and
its main assets.
In light of the decision by Boston, the Board assessed several alternatives for
its strategy to market and distribute Aorfix(TM) in Europe and the US, where it
had been expected that Boston would want to secure rights to Aorfix(TM) at the
time of taking up its option.
The Board concluded that Shareholders' interests would be best served by a
strategy of:
* continuing to market Aorfix(TM) through a select group of national
distributors outside the US, supported by clinical specialists in major
markets;
* progressing further the pivotal US clinical trial for Aorfix(TM) before
engaging a strategic marketing partner in the US;
* investing in manufacturing capacity and capability to meet forecast demand
for Aorfix(TM), so as to reduce both reliance on external suppliers and unit
costs;
* completing negotiations with Medtronic regarding EndoRefix(TM);
* focusing available product development resources on the thoracic stent
graft project;
* building a portfolio of novel projects within the Polymer Coatings
Division that would be attractive licensing candidates to other medical
device companies; and
* disposing of trade investments and raising further equity finance to fund
implementation of this strategy.
OUS Commercialisation and Clinical Trials
Following Boston's decision, the Company strengthened its sales and marketing
infrastructure. The UK sales force was rebuilt and extended to include support
in major markets for the Company's network of distributors. The news that Boston
was not exercising its option to distribute Aorfix(TM), although disappointing,
was highly motivating to the Company's local distributors, many of whom had been
concerned about committing resources to the product whilst the Boston option
remained in place. The Company signed up new distributors in countries such as
Italy, Poland, Slovenia, Spain, Turkey and Brazil during 2006 widening its
geographic coverage and bringing the total number of countries in which
Aorfix(TM) is available to 22.
It is anticipated that, over time, the Company will benefit from higher margins
on Aorfix(TM) sales than were available under the agreement with Boston by
selling direct in the UK and through local distributors.
Orders for Aorfix(TM) in Europe are showing promising growth as the investment
in sales and marketing infrastructure yields results and clinicians become
increasingly aware of the growing body of superior clinical data for the
product. The Company has recently held a major symposium at the International
Charing Cross meeting in London, where early US experience with Aorfix(TM) in
the US clinical trial was presented. This was supplemented by European clinical
experience, including data on the use of Aorfix(TM) in challenging vascular
anatomy. The total number of Aorfix(TM) implants worldwide now exceeds 250 and
Aorfix(TM) devices have now been in situ in some patients for five years. The
twenty-four month clinical data presented in September 2006 at the
Cardiovascular and Interventional Radiological Society of Europe (CIRSE) meeting
in Rome was exceptionally good with 100% (n=18) of cases showing freedom from
AAA-related mortality, aneurysm rupture, stent migration, stent fracture and
device-related endoleak. Furthermore, there were no device-related clinical
treatments in any of the patients and a decrease in aneurysm diameter was
measured in 83% (n=18) of cases. These excellent clinical data, taken together
with the growing body of evidence suggesting that Aorfix(TM) is the only stent
graft that can successfully treat abdominal aortic aneurysms with severely
angulated necks, give the Directors grounds for considerable optimism for the
prospects for Aorfix(TM). An improved, more flexible, delivery system for
Aorfix(TM), which facilitates the use of the device in patients with tortuous
vasculature, was favourably received on launch in April 2006 and has recently
been approved for use in the pivotal US clinical trial.
The Arbiter II trial in Europe commenced in September 2006. The Directors
anticipate that this trial will result in Aorfix(TM) being licensed for use in
aneurysms with neck angulations of up to 90degrees, for which no alternative
endovascular stent grafts are currently approved. Currently three centres are
enrolling patients and a further six are in the roll-in/negotiation phase; three
patients have been enrolled. The Directors expect recruitment of the remaining
27 targeted patients to be completed in early 2008, with the label claim for use
in aneurysms with high-angled necks to be received in Q3 2008.
The worldwide market for AAA stent grafts is expected to reach almost $1 billion
by 2010. This growth is expected to be driven both by an increase in the number
of people diagnosed with AAA disease and endovascular repair gaining market
share from open surgery. Reasons for the increase in diagnosis include an ageing
population, a rising incidence of causal factors such as obesity and high blood
pressure, and greater screening for the disease. Endovascular repair is expected
to gain market share from open surgery due to patient preference, quality of
life benefits and its faster recovery time that leads to better utilisation of
healthcare resources and a lower overall cost. For example, in Australia 65% of
repair procedures are now by endovascular techniques.
There are approximately 15,000 endovascular AAA repair procedures performed in
Europe each year of which approximately 40% are performed using the Zenith
device (Cook Medical, Inc.), 32% using the Talent device (Medtronic) and 20% the
Excluder (W.L. Gore & Associates, Inc.).
US Clinical Trial and Commercialisation
Although later than planned, due to delays in negotiating clinical contracts,
the pivotal US clinical trial of the Aorfix(TM) endovascular stent graft in the
treatment of AAA (PYTHAGORAS) has recently been gaining momentum as a result of
the efforts of the subsidiary operations in Boston MA led by Peter Phillips, a
co-developer of Aorfix(TM). The US operation has an experienced clinical and
regulatory team and the resources to achieve regulatory approval of Aorfix(TM)
in the US.
A meeting of key US clinical investigators took place in August 2006 during
which support for Aorfix(TM) was expressed with particular interest being shown
for the product's unique ability to treat aneurysms with neck angulations over
60degrees and patients with tortuous iliac arteries (together estimated to
represent 20 to 40% of all cases). The investigators recommended that the
Company should change its current strategy to one where each clinical centre
would focus on carrying out implants in the 60degrees+ range, for which no
alternative endovascular stent grafts are currently approved, and to introduce
the Generation II delivery system in order to facilitate a more rapid completion
of the trial. Approval of the IDE supplement for the Generation II delivery
system was received on 2 April 2007. The Company subsequently submitted a
further supplemental IDE to further progress these recommendations, conditional
approval of which was announced on 29 May 2007. This supplemental IDE widens the
entry criteria to include patients with aneurysm neck angulations of up to 90
degrees and increases the number of centres in the study from 10 to 20.
Furthermore, the total number of endovascular patients for whom data are to be
submitted will be reduced to 160 from up to 385, based on new statistical
analysis.
The change to the design of the PYTHAGORAS study is summarised below.
Number of patients
Original IDE1 Supplement2
0-60degrees neck angle, endovascular 275 40
60degrees+ neck angle, endovascular 1103 120
Open surgery 110 60
1 As at the time of the IPO in December 2005
2 The number of patients enrolled may be up to 25% higher to compensate
for patients who may be lost to follow up
3 Planned supplement to original IDE after 100 cases performed
The recruitment status of the PYTHAGORAS study is summarised below.
Current total
Number of Aorfix(TM) implants performed 13
Number of open surgery controls performed 19
Number of active centres 9
The Company has, in some cases, experienced minor porosity problems with the
fabric used in its stent grafts, commonly referred to as "blush", which have
shown to be resolved on routine follow-up. Although of no apparent serious
clinical significance, the Company is further tightening the specifications of
the fabric used in manufacture so as to eliminate this phenomenon. The Company
has agreed with the FDA to submit the data on the first 21 implants in the US
clinical trial for its review. Allowing for the slight delay from this review,
the trial implants are expected to be completed in H1 2008. With one-year
follow-up and PMA submission in H1 2009, approval is anticipated around the end
of 2009. The approved indication would be for patients with aneurysm neck
angulations of between 0 and 90degrees.
The Company is maintaining its strategy to develop a partnership with a leading
medical device company for the marketing and distribution of Aorfix(TM) in the
US. The decision by Boston not to exercise its option presents an opportunity
for certain potential partners that did not wish to market a product which was
also marketed by Boston outside the US. As FDA approval for Aorfix(TM) is not
forecast until 2009, the Company does not expect to announce a strategic
partnership for the US until closer to the anticipated launch of the product,
despite interest being shown by several large medical device companies.
There are currently around 250,000 patients diagnosed in the US with AAA disease
each year, of which the Directors estimate that around 165,000 receive no
interventional therapy either due to the small size of the aneurysm or the
patients being unsuitable for either open or endovascular surgery. Of the 85,000
patients estimated to undergo interventional therapy it is believed that around
33,000, or just under 40%, receive endovascular repair. The US endovascular
market is currently shared between three main products and the Excluder device
(Gore) is the market leader with approximately 36% of the market, closely
followed by the Zenith (Cook) with a 33% share and the AneuRx (Medtronic) with
30%.
By 2010, the number of people diagnosed with AAA disease in the US is expected
to have reached 300,000 a year and the Directors believe that just over 50%
(63,000) of the anticipated 120,000 receiving interventional therapy will
undergo endovascular repair, which will result in a US endovascular market of
more than $700 million. Based on market research performed by Bridgehead
International and anecdotal information from opinion leaders, the Directors
believe that around 20% (and possibly up to 40%) of cases presenting have
aneurysms with high-angle necks and/or tortuous iliac arteries. Currently
available endovascular devices are not licensed for the treatment of such cases
but the more flexible design of Aorfix(TM) makes it more suitable for use in such
patients and it is expected that, unlike competitor products, Aorfix(TM) will be
approved for use in aneurysms with neck-angles of up to 90degrees. Based on the
forecast number of patients receiving interventional therapy in 2010, this
segment, in which Aorfix(TM) will have a competitive advantage, is estimated to
be worth over $250 million and will, in the Directors' opinion, provide an
excellent springboard for the penetration of Aorfix(TM) into the wider market.
Manufacturing
The Company has faced several challenges in scaling-up manufacturing processes
from those designed to meet the needs of a development organisation to ones
capable of meeting the needs of a growing commercial organisation. Although the
problems associated with the loading of the stent graft into the delivery device
that led to the voluntary suspension of clinical cases with Aorfix(TM) during
December 2006 and January 2007 have now been resolved, further improvements to
this process will be introduced during 2007 to increase capacity from the
current 20 Aorfix(TM) clinical kits per week. Management recognises that further
strategic changes are required, and is actively pursuing a strategy to:
* bring certain manufacturing in-house under one quality system;
* build inventory for rapid customer response;
* further improve manufacturing capability and expertise; and
* increase capacity to meet anticipated worldwide demand.
Significant progress with this strategy has been made in 2007 with the
appointment of a new Director of Quality from Johnson & Johnson. In addition,
the Company is proposing to acquire Culzean Medical Devices Limited, a company
specialising in medical fabrics based in Prestwick, Scotland. This will bring
invaluable expertise in medical device fabrics as well as adequate clean room
and device assembly areas for product development and advanced engineering. This
will permit the main facility at Didcot to focus on manufacturing for commercial
and clinical requirements.
EndoRefix(TM)
The Company is delighted to have entered a strategic partnership with Medtronic
Inc. for the Company's EndoRefix(TM) endostapler device, which Medtronic will be
distributing on a worldwide basis. EndoRefix(TM) will be marketed by Medtronic
under the brand name Securant(TM).
As well as a distribution agreement under which Lombard will supply the product
at an agreed transfer price, Medtronic have entered into a "co-exclusive"
license to use EndoRefix(TM) technology in the development of "next generation"
vascular devices. This agreement becomes effective on receipt of a $3 million
milestone payment due to the Company on receipt of FDA approval of
EndoRefix(TM). Lombard will receive royalty payments of up to $5 million from
sales of Medtronic products using the licensed technology.
European CE Mark approval for the endovascular stapler was received in November
2006, with FDA approval now expected in H2 2008.
The first 10 clinical uses of EndoRefix(TM) will be performed under the Lombard
label and are anticipated to be completed later this year. Following the
successful completion of these cases, the Medtronic distribution agreement will
become effective and the Company will receive a $3 million loan facility from
Medtronic. Medtronic will then undertake a limited release launch in centres of
excellence in key markets in Europe.
Thoracic and other projects
Progress on the stent graft for thoracic aortic aneurysms ("TAAs") has suffered
slightly as development resources have been required to help address the
challenges encountered in moving from development to commercial manufacturing
operations for Aorfix(TM). However, preclinical experience with this device has
been very positive and the Company expects both European and US clinical trials
to start in the second half of next year with European approval expected in H2
2010 followed by US approval one year later.
Anticipated timings for the development and regulatory approval of the devices
within the Cardiovascular Devices Division are summarised below.
Aorfix(TM) EndoRefix(TM)
AAA TAA
Device development Complete Complete Complete
EU clinical trials Complete To commence N/A
H2 2008
EU approval Complete H2 2010 Complete
US clinical trials Ongoing To commence To commence
H2 2008 Q4 2007
US FDA submission H1 2009 2010 Q2 2008
US approval Q4 2009 2011 Q3 2008
Development within the Polymer Coatings Division
There have been several positive developments at the Company's Polymer Coatings
Division including:
* in October 2006, the Company signed a collaboration agreement with Axordia
Limited (a subsidiary of Biofusion plc) and the University of Sheffield to
develop a revolutionary approach to treating coronary restenosis by
utilising a stent coating containing endothelial cells grown from a stem
cell line to promote early healing of the artery after angioplasty. This
research programme is the subject of #0.9 million in grant funding from the
Department of Trade and Industry and the Medical Research Council; and
* in April 2006, the Company signed a collaboration agreement with Amgen,
Inc. and the University of Sheffield relating to the use of the Company's
technology to deliver one of Amgen's proprietary anti-inflammatory drugs via
a drug-eluting stent for the prevention of coronary restenosis. Preclinical
trials are ongoing and are expected to complete later this year. If
successful, the Company will look to license its rights under this programme
during 2008.
The Company is also in discussions with a potential partner for the application
of its coating technology both in combination with anti-microbial agents in the
field of urology and to form a lubricious coating for percutaneous transluminal
coronary angioplasty (PTCA) catheters. The potential partners are currently
evaluating certain coatings and the Company expects to complete discussions on
its urology coating by the end of 2007 and on its PTCA coating during 2008.
Trade investments
The Company held two investments in other medical device companies during 2006.
In February 2007, EndoArt SA, a Swiss company developing programmable obesity
control devices, was acquired by Allergan, Inc. and the Company's stake was
purchased for $3.2 million (approximately #1.6 million), as announced on 22
February 2007. The Company received $2.8 million (#1.4 million) on closing. The
remaining consideration of $0.4 million (#0.2 million) will be held in escrow
until February 2009, against any potential warranty claims made by Allergan
under the terms of the purchase agreement. Lombard will record a profit of #1.1
million from the sale in 2007.
The Company also holds an investment in Vascular Concepts Ltd, a UK company
developing and marketing drug-coated coronary stents. The Company intends to
realise this investment at the appropriate time.
Preliminary results
The Company is today publishing its preliminary results for the year ended 31
December 2006.
Current Trading and Prospects
In the preliminary results announcement published today, the Chairman
highlighted the progress made in 2006 that included, amongst other things, two
CE Mark approvals, the announcement of excellent clinical data for Aorfix(TM),
and the collaboration with Medtronic for EndoRefix(TM).
This progress has continued in 2007. Clinical procedures for Aorfix(TM) have
continued to increase with over 250 implants having now been performed. The
pivotal US trial for Aorfix(TM) has continued to gain momentum with 13 cases now
completed. The FDA approval to use the improved delivery device is expected to
increase recruitment rates, as is the supplement to the IDE that targets the
trial at those patients with high-angle-neck aneurysms for which there is
currently no approved endovascular alternative.
Although sales of Aorfix(TM) continue to be limited by the availability of
stock, progress has been made in this area with a number of improvements to the
production process currently being implemented. The proposed acquisition of
Culzean Medical Devices Limited will provide important expertise in medical
fabrics as well as adequate clean room and device assembly areas for product
development and advanced engineering. This will permit the main facility at
Didcot to focus on manufacturing for commercial and clinical requirements.
The Company continues to work closely with Medtronic and its contract
manufacturer on the validation of the commercial manufacturing process for
EndoRefix(TM). This has caused some delay to the clinical use of the product,
which is now expected in H2 2007 with FDA approval in H2 2008.
Lessons learnt from the commercial production of Aorfix(TM) have been fed into
the thoracic development project which is progressing, albeit somewhat slower
than originally envisaged, due to engineering resources being diverted to
Aorfix(TM) and EndoRefix(TM). Clinical trials for the thoracic device are
expected to commence in H2 2008 with European approval in 2010 and US approval a
year later.
The Company's Polymer Coatings Division continues to progress its strategy of
building a portfolio of projects in large markets that would be attractive
licensing candidates to other medical device companies.
The Directors continue to believe that the prospects for the Company are
promising with the unique attributes of its Aorfix(TM) stent graft having real
value in the growing AAA market.
Use of Funds
The Company is raising #6.6 million (net of costs) to progress the strategy
described above. The funds raised will allow the Company to take advantage of
the increasing demand for Aorfix(TM) in markets outside the US, to bring
EndoRefix(TM) to a regulatory approved position in the US and to achieve greater
control over its manufacturing processes. The proceeds of the Subscription and
Placing, together with other funds available to the Company, will be applied in
the following approximate proportions:
* Production scale-up - 5%
* US Aorfix(TM) clinical trial - 20%
* Additional product development (principally Aorfix(TM) and EndoRefix(TM)) -
30%
* Sales and marketing - 20%
* Working capital - 25%
Working Capital
At 31 May 2007, the Company had cash and short-term deposits of #1.9 million.
For the Company to be able to progress its stated strategy, it is essential that
the Company raises the proceeds pursuant to the Placing and Subscription.
If the Resolutions are not passed and the Board is unable to find alternative
sources of funding, the Company will have insufficient resources to continue to
trade beyond July of this year.
The Directors believe that the proceeds of the Placing and the Subscription will
raise sufficient working capital for the Company's present requirements but that
the Company will need to raise further funds within the next 12 months in order
to take the Company's business to the point where it becomes cash generative.
Principal terms of the Subscription Agreements
Under the terms of the Subscription Agreements, the Subscribers have
conditionally agreed to subscribe for, in aggregate, 10,532,660 Subscription
Shares at the Issue Price and to take up A Warrants over 1,579,899 Ordinary
Shares and B Warrants over 1,579,899 Ordinary Shares.
The Subscription Agreements are subject to Admission having occurred.
The Subscription Agreements contain certain warranties and representations given
by the Subscribers to the Company.
Principal terms of the Placing Agreement
Under the terms of the Placing Agreement, Nomura Code has conditionally agreed,
as agent for the Company, to use reasonable endeavours to procure subscribers
for the Placing Shares at the Issue Price and for A Warrants over 2,850,000
Ordinary Shares and B Warrants over 2,850,000 Ordinary Shares and, to the extent
that it fails to procure such subscribers, to subscribe for such Ordinary Shares
and to take up the Placing Warrants as principal upon the terms and subject to
the conditions of the Placing Agreement. The Placing Agreement is conditional,
inter alia, upon the Resolutions being passed by Shareholders at the EGM and
Admission having occurred.
Subscription by Directors
As part of the Placing, Alistair Taylor, Brian Howlett and Timothy Hall, all
Directors of the Company, will subscribe for 150,000, 40,000 and 40,000 Ordinary
Shares, respectively, at the Issue Price. Pursuant to the terms of the Placing,
these Directors will receive 45,000, 12,000 and 12,000 Warrants, respectively.
As a consequence of these subscriptions, Mr Taylor, Mr Howlett and Mr Hall will
hold 1.73%, 0.06% and 0.06% of the Company's Enlarged Issued Share Capital,
respectively.
The Board, excluding Mr Taylor, Mr Howlett and Mr Hall, considers, having
consulted with its nominated adviser, Nomura Code, that the terms of these
subscriptions by Directors are fair and reasonable in so far as the Company's
Shareholders are concerned.
Terms of the Warrants
Pursuant to the terms of the Warrant Instruments, the Company will issue
Warrants to the Subscribers and the Placees in accordance with the terms of the
Subscription Agreements and the Placing Agreement. The A Warrants are
exercisable in whole or in part at any time up to and including 15 June 2010. An
exercise price of 31 pence per Ordinary Share is payable on exercise of the A
Warrants. The B Warrants are exercisable in whole or in part at any time up to
and including 15 June 2012. An exercise price of 37 pence per Ordinary Share is
payable on exercise of the B Warrants. The Warrants are transferable in certain
circumstances.
The Board, excluding Mr Taylor, Mr Howlett and Mr Hall, considers, having
consulted with its nominated adviser, Nomura Code, that the terms of these
subscriptions by Directors are fair and reasonable in so far as the Company's
Shareholders are concerned.
The New Ordinary Shares that are the subject of the Placing and the Subscription
(the "New Ordinary Shares") are not being offered or sold to any person in the
United Kingdom, other than to qualified investors as defined in Section 86(7) of
the Financial Services and Markets Act 2000 ("FSMA"), being persons falling
within Article 2.1(E)(I), (II) or (III) of Directive 2003/71/EC (the "Prospectus
Directive"), which includes legal entities which are regulated by the Financial
Services Authority (the "FSA") or entities which are not so regulated whose
corporate purpose is solely to invest in securities.
The information contained herein is not for publication or distribution into the
United States. The material set forth herein is for informational purposes only
and is not intended, and should not be construed, as an offer of securities for
sale into the United States or any other jurisdiction. The securities of the
Company described herein have not been and will not be registered under the US
Securities Act of 1933, as amended (the "Securities Act"), or the laws of any
state of the United States, and may not be offered or sold within the United
States, except pursuant to an exemption from, or in a transaction not subject
to, the registration requirements of the Securities Act and applicable state
laws. There is no intention to conduct a public offering of securities in the
United States.
This announcement does not constitute an offer to sell or issue or a
solicitation of an offer to buy or subscribe for New Ordinary Shares in any
jurisdiction including, without limitation, Canada, Australia, South Africa
Japan or any other jurisdiction in which such offer or solicitation is or may be
unlawful. This announcement and the information contained herein are not for
publication or distribution, directly or indirectly, to persons in Canada,
Australia, South Africa or Japan unless permitted pursuant to an exemption under
the relevant local law or in any jurisdiction in which such publication or
distribution is unlawful.
The distribution of this announcement, the Placing and/or Subscription and/or
issue of the New Ordinary Shares in certain jurisdictions may be restricted by
law. No action has been taken by the Company or Nomura Code that would permit an
offer of the New Ordinary Shares or possession or distribution of this
announcement or any other publicity material relating to such New Ordinary
Shares in any jurisdiction where action for that purpose is required. Persons to
whose attention this announcement has been drawn are required by the Company and
Nomura Code to inform themselves about and to observe any such restrictions.
Nomura Code is authorised and regulated by the Financial Services Authority, is
acting for the Company and for no one else in connection with the Placing and
Subscription and will not be responsible to anyone other than the Company for
providing the protections afforded to the customers of Nomura Code or for
affording advice in relation to the Placing, the Subscription, or any other
matters referred to herein.
Appendix I
Definitions
The following definitions apply throughout this announcement, unless the context
requires otherwise:
"Admission" the admission of the Placing Shares and the Subscription Shares to
trading on AIM becoming effective pursuant to paragraph 6 of the AIM
Rules
"AIM" a market operated by the London Stock Exchange
"AIM Rules" the rules governing the admission to, and operation of, AIM as
published by the London Stock Exchange from time to time
"A Warrants" the warrants to subscribe for Ordinary Shares (at an exercise price of
31 pence per Ordinary Share)
"Boston" Boston Scientific B.V., a wholly owned subsidiary of Boston Scientific
Corporation
"B Warrants" the warrants to subscribe for Ordinary Shares (at an exercise price of
37 pence per Ordinary Share)
"Camden Partners" Camden Partners Strategic Fund II-A, LP and Camden Partners Strategic
Fund II-B, LP
"Company", "Lombard" or "LMT" Lombard Medical Technologies PLC
"Directors" or "Board" the board of directors of Lombard
"Extraordinary General Meeting" or "EGM" the extraordinary general meeting of Lombard convened for 10.00 a.m.
on 9 July 2007 (or any adjournment thereof)
"IPO" the admission to trading on AIM of the Company's then entire issued
share capital on 13 December 2005
"Issue Price" 25 pence per new Ordinary Share
"London Stock Exchange" London Stock Exchange plc
"Medtronic" Medtronic, Inc.
"Nomura Code" Nomura Code Securities Limited
"Ordinary Shares" ordinary shares of 2 pence each in the capital of Lombard
"Placees" subscribers for Placing Shares and Placing Warrants pursuant to the
Placing Agreement
"Placing" the placing of the Placing Shares and the Placing Warrants pursuant to
the Placing Agreement
"Placing Agreement" the conditional agreement dated 15 June 2007 and made between Nomura
Code and the Company in relation to the Placing
"Placing Shares" the 19,000,000 new Ordinary Shares to be issued pursuant to the
Placing Agreement
"Placing Warrants" the A Warrants and the B Warrants to be granted by the Company
pursuant to the Placing Agreement on the basis of 3 A Warrants for
every 20 Placing Shares subscribed (subject to rounding down for any
fractional entitlements) and 3 B Warrants for every 20 Placing Shares
(subject to rounding down for any fractional entitlements)
"Resolutions" the resolutions set out in the notice of the EGM and "Resolution"
shall mean any of them
"Shareholders" holders of Ordinary Shares
"Subscribers" subscribers for the Subscription Shares and the Subscription Warrants
pursuant to the Subscription Agreements, being Jennison, Camden
Partners Strategic Fund IIA, Camden Partners Strategic Fund IIB,
Public Employee Retirement System of Idaho, City of Milford Pension &
Retirement Fund, City of Stamford Fireman's Pension Fund, Asphall
Green, Inc., Albert L. Zesiger, Barrie Ramsay Zesiger, David Zesiger,
Dominic J. Mizio, J.P. Morgan Trust Co. (Bahamas) Ltd. as trustee U/A/
D/11/30/93, James F. Cleary, Jeanne L. Morency, John Rowan, Nicola
Zesiger Mullen, Peter Looram, Robert K. Winters, Susan Uris Halpern
and Theeuwes Family Trust, Felix Theeuwes Trustee, or such persons as
they nominate
"Subscription" the subscription for the Subscription Shares and the Subscription
Warrants pursuant to the Subscription Agreements
"Subscription Agreements" the agreements dated 15 June 2007 and made between the Company andthe
Subscribers
"Subscription Shares" the 10,532,660 new Ordinary Shares to be issued pursuant to the
Subscription Agreements
"Subscription Warrants" the A Warrants and the B Warrants to be granted by the Company
pursuant to the Subscription Agreements on the basis of 3 A Warrants
for every 20 Subscription Shares subscribed (subject to rounding down
for any fractional entitlements) and 3 B Warrants for every20
Subscription Shares subscribed (subject to rounding down for any
fractional entitlements)
"US" or "USA" or
"United States of America" the United States of America, each state thereof, its territories and
possessions, and all areas subject to its jurisdiction
"Warrant Instruments" the deed polls dated 15 June 2007 constituted by the Company pursuant
to which the Placing Warrants and the Subscription Warrants will be
issued
"Warrants" the Subscription Warrants and the Placing Warrants
Appendix II
Glossary
abdominal aortic aneurysm or AAA balloon-like enlargement of the aorta in the region of the abdomen
(occurring in the length of the aorta between the diaphragm and the iliac
bifurcation)
aneurysm balloon-like enlargement of a blood vessel resulting from a weakening in
the vessel wall
coronary restenosis re-narrowing of the coronary artery following corrective surgery to widen
it
drug eluting controlled release of one or more drugs by a chemical complex, such as a
polymer coating
endoleak or endovascular leakage leakage of blood beyond the stent graft into the space between the outer
stent wall and the wall of the blood vessel
endostapler a stapling instrument used endoscopically for the purposes of fixing
tissues to other tissues or devices
endothelial cells the cells lining the luminal surface of blood vessels
EVAR endovascular aneurysm repair
FDA the US Food and Drug Administration
Investigational Device Exemption or an approval by the FDA for a device that permits its use in a clinical
IDE study to collect the safety and effectiveness data required for an
application to market the device
nitinol an alloy of nickel and titanium that, once initially set in a defined
shape, returns to that shape following distortion
percutaneous heart valve an artificial heart valve deployed during minimally invasive surgery to
replace a diseased heart valve
PMA Pre-Market Approval
PTCA percutaneous transluminal coronary angioplasty, a minimally invasive
surgical technique to remodel the coronary arteries
stent graft a tubular device made of fabric attached to an expandable metal structure.
Once the metal structure is expanded, the device forms a rigid tube
thoracic aortic aneurysm or TAA balloon-like enlargement of the aorta in the region of the thorax
(occurring in the length of the aorta between the heart and the diaphragm)
This information is provided by RNS
The company news service from the London Stock Exchange
END
IOESFSFIISWSEEM
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