Final Results
Aortech International PLC
06 September 2007
6 September 2007
AorTech International plc
Results for the year ended 31 March 2007
AorTech International plc (AIM: AOR) ('AorTech' or the 'Company'), the
biomaterials and medical device development company, today announces its results
for the year ended 31 March 2007.
Operational Highlights
• Partnership with St Jude Medical for cardiac pacing leads continuing
well, with expansion of manufacturing capacity of Elast-Eon extrusions and
mouldings in response to customer demand;
• FDA approved human use of its polymer technology Elast-Eon;
• Customer evaluations underway in the areas of cardiac surgery,
cardiology, orthopaedics and urology:
- October 2006 - non-exclusive licence and material supply agreement signed
with Allium Medical Inc in the field of non-vascular stents;
- December 2006 - Exclusive material licensing and supply agreement with
Avalon Laboratories, leading supplier of cardiopulmonary vascular cannulae;
- December 2006 - Exclusive material licensing agreement signed with
Harland Medical Systems, LLC in the field of short-term guide wire and catheter
coating applications
- April 2007 - Supply and licence agreement with Cardiosolutions, Inc., for
the purchase and use of Elast-EonTM in the field of mitral valve repair
• Conditional re-approval of gel-filled breast implants by FDA and three
patents filed for AorTech breast implant technology;
• Successful presentation of the polymer heart valve at the eminent TCT
symposium in October 2006;
• Creation of a Medical Advisory Board - appointment of esteemed plastic
surgeons, V. Leroy Young, M.D., and Mark L Jewell;
• Post period-end - entered a licensing and supply agreement with a global
medical device company with a potential income value of up to c.US$32m for
the evaluation of Elast-EonTM along with royalty payments;
Financial Highlights
• Group turnover £0.3m (2005/6 £1.4m inclusive of a £1.1m upfront payment
from St Jude Medical);
• Loss after tax £2.1m (2005/6 £0.5m loss)
• At 31 March 2007, cash reserves of £1.5m (2006: £2.7m)
• Post period end placing raised £5.1 million (before expenses), to fund
further development plans.
Jon Pither, Chairman, said:
'We have made significant progress during the past two years culminating in the
post balance sheet agreement with a global medical device company. During this
time, we have achieved multinational regulatory approvals, a reputation for
quality and service, thousands of human implants of our premier biostable
polymer Elast-EonTM, and significantly increased operational capacity.
'The Placing will provide us with the necessary resource to carry through our
development plans, as we seek to deploy our proven technology within further
large scale and life sustaining markets. The Board is confident that AorTech has
the technology, resources, partners and commitment to fully realise the
potential of our unique Elast-EonTM polymer and thereby to build shareholder
value over the coming years.'
- Ends -
For further information please contact:
AorTech International plc
Frank Maguire, Chief Executive Tel: + 1 801 201 4336
Evolution Securities
Bobbie Hilliam Tel: +44 20 7071 4300
Chris Clarke
Hogarth Partnership Limited Tel: +44 20 7357 9477
Melanie Toyne-Sewell/Sarah Richardson
Notes to Editors:
About AorTech International plc
Listed on AIM in London, AorTech International plc wholly owns AorTech
Biomaterials based in Melbourne, Australia. AorTech Biomaterials was formed in
July 1997 to develop and commercialise Elast-Eon, a highly useful and biostable
co-polymer in the medical device and drug delivery fields.
AorTech's Elast-Eon technology is the product of a decade of fundamental
research into biologically stable materials. Elast-Eon materials are patented,
high silicone content, polyurethane copolymers which exhibit unparalleled
biological and mechanical performance.
AorTech is firmly focused on the development and refinement of this material for
the medical community, with the aim of providing a wide range of high
performance Elast-Eon materials in a variety of application specific
formulations and densities, for use in medical devices.
RESULTS FOR THE YEAR ENDED 31 MARCH 2007
CHAIRMAN'S STATEMENT
I am pleased to report that in the year ended 31 March 2007 the Group made
highly encouraging progress in a number of respects including the filing of
three further patents. Moreover since the year end it has entered into a
licensing and supply agreement for the evaluation of our patented polymer,
Elast-EonTM, with a global medical device company. Accordingly, despite
reporting an increased loss for the year, the Board believes that the Company
can look forward to a very promising period ahead.
Financial Review
Group turnover for the year was £276,000. This was lower than the £1.4m in the
previous year which included £1.1m from a one-off payment resulting from an
agreement signed with St Jude Medical. Operating expenses for the year were
£2,348,000, an increase of £481,000 over the previous year due, in the main, to
the move to new premises in Australia and up-scaling of our operational capacity
to meet the expected increase in demand for Elast-EonTM polymer. The operating
expenses included £821,000 of development expenditure (2006: £634,000) and
amortisation of intangible fixed assets amounting to £148,000 (2006: £99,000).
The loss after tax for the year was £2.1m (2006: £523,000) and at 31 March 2007
the Group had cash reserves of £1.5m (2006: £2.7m).
The greater part of this Statement focuses on the very important commercial and
technical progress that has been and continues to be achieved.
Operational Review
Manufacturing and Supply of Elast-EonTM bulk material
Following the granting of the regulatory approvals in the United States and
Europe in 2006 for Elast-EonTM in human use, our principal operational focus for
2006/07 was to create a capable and reliable manufacturing infrastructure able
to support the large scale and life-sustaining nature of our licensees' medical
device products. I am pleased to report that our new Melbourne technology and
manufacturing facility has achieved very positive results during the year,
including 100% on-time delivery to customers, 100% quality certification and
acceptance of delivered product and an overall reduction in the baseline costs
from the previous year. This has been achieved in a period when we expanded our
manufacturing capacity by 67%, which we believe is sufficient to satisfy our
customers' growing polymer volume requirements through to the end of 2008.
Elast-EonTM Component Manufacturing
In response to our customers' requests for Elast-EonTM extrusions and mouldings,
we have taken steps to improve our capability in the area of medical-grade
extrusion. AorTech will benefit directly from the revenue associated with tubing
component orders, and indirectly by accelerating the customer evaluation process
and, therefore, the achievement of higher-value late stage development milestone
payments that are characteristic of our material licence agreements.
We are very encouraged by the results to date and expect that Elast-EonTM
extrusion components will comprise a significant and increasing proportion of
our polymer business revenues going forward.
Market and Customers
The major revenue potential and increased value return for the Group is expected
to arise from joint venture projects and licensing agreements with major medical
device companies. In addition, we estimate the market for our supply of bulk
Elast-EonTM polymer to be approximately US$100m and growing at a rate of 6-10%
per annum. We believe that our customers have recognised Elast-EonTM as a top
quality silicone-urethane material for soft, long-term, high fatigue,
blood-contacting implants.
During the year, the technology focus has been towards developing softer
materials which compete more directly with medical grade silicone, and we have
expanded our patent portfolio by a number of new submissions and approvals. We
have concentrated, in particular, on collaboration with major biomaterials
research institutes and universities. As a result of this work we have achieved
greater profile for Elast-EonTM, different aspects of which were presented at
four separate conferences and also featured in three journal publications.
During the year there were a number of customer evaluations carried out across a
range of applications for Elast-EonTM. In addition to the work already underway
in the areas of cardiac surgery, cardiology, orthopaedics and urology, we have
invested and will invest further in other potential applications including
neurostimulation, pulmonary, drug delivery, women's health, ventricular assist
and non-coronary stent-based drug delivery, all of which are being developed
within customer partnerships.
Technology Developments
Polymer Heart Valve
During the past year, our heart valve technology has been evaluated in the
in-house laboratories of major medical device companies who could become our
partners in the future. This strategy is to enable us to demonstrate and verify
the durability and performance characteristics of our heart valve product.
We believe that good progress is being made towards the commercialisation of the
Company's heart valve products within a co-development or partnership structure,
and that these products have the potential to contribute significantly to our
future revenues when regulatory and clinical milestones are achieved.
Breast Implants
The conditional re-approval of the gel-filled breast implant by the US FDA in
November 2006 has had a substantial, immediate and long-term impact on breast
implant technology and the related market dynamics.
In the short term, the leading suppliers of these products are placing a strong
focus on the re-introduction of such implants into the US. They have devoted
significant resources to manufacturing processes, surgeon training and patient
awareness programmes and the establishment of a clinical monitoring function
capable of supporting the conditions upon which US FDA approved these
silicone-gel implants. In the longer term, and because of the re-approval of the
silicone-gel device, the market is seeking the next-generation product which we
believe AorTech is well positioned to provide.
During the past year, we have continued to refine our breast implant shell and
filler materials, and to carefully examine these materials in relation to the
guidelines published by FDA. We believe that the way forward for this technology
is to secure a co-development deal with a suitable partner and we remain
optimistic of achieving this. During the last year, we have filed three patents
covering the use of our materials and newly invented processes in the fields of
gel technology, in-situ cure and the development of a minimally invasive breast
implant.
In addition to the breast implant and heart valve projects, the Group has
commenced new projects in the areas of urology, vascular grafts and non-coronary
stent-based drug delivery. I look forward to reporting on progress with these
projects in the coming year.
Summary
We have made very significant progress during the past two years in particular,
having achieved multinational regulatory approvals, a reputation for quality and
service, thousands of human implants of our premier biostable polymer,
Elast-EonTM, and significantly increased operational capacity.
Your Board believes that the recent announcement of a partnership deal for one
of our major development programmes which, subject to AorTech fulfilling
specific milestone targets, could realise income of up to approximately US$32m
in the years ahead together with future royalty payments, and therefore
validates our strategy to generate shareholder value through licensing and
supply of an innovative, world-class polymer. Much credit for this progress goes
to our Australian team based in their new Melbourne facility.
Since the year end, we have raised £5.1m by way of a placing of 1,000,000 new
Ordinary Shares which will provide us with the necessary resource to carry
through our development plans.
Finally I take this opportunity to thank all of our staff for their continued
commitment to the Company and to our shareholders for their continued support
over the past twelve months. Your Board is confident that AorTech has the
technology, resources, partners and resolve to fully realise the potential of
our unique Elast-EonTM polymer and thereby to build shareholder value over the
coming years.
Jon Pither
Chairman
CONSOLIDATED PROFIT AND LOSS ACCOUNT
FOR THE YEAR ENDED 31 MARCH 2007
Notes 2007 2006
£000 £000
Turnover 2 276 1,425
Continuing operations
Cost of Sales (158) (223)
Gross Profit 118 1,202
Net operating expenses (2,348) (1,867)
---------------------------------------------- ------ --------- ---------
Net operating expenses include:
Development expenditure (821) (634)
Amortisation of intangible fixed assets (96) (99)
--------------------------------------------- ------ --------- ---------
Group operating loss (2,230) (665)
Interest receivable 109 142
Loss on ordinary activities before taxation (2,121) (523)
Taxation - -
Loss for the financial year (2,121) (523)
Loss per ordinary share
Basic and diluted 3 (55.67p) (13.74p)
There is no difference between the losses stated above and their historical
cost equivalent.
All results are derived from continuing
operations.
CONSOLIDATED STATEMENT OF TOTAL RECOGNISED GAINS AND LOSSES
FOR THE YEAR ENDED 31 MARCH 2007
2007 2006
£000 £000
Loss for the financial year (2,121) (523)
Currency translation differences arising on (25) (23)
consolidation
Total losses recognised since last annual (2,146) (546)
report
CONSOLIDATED BALANCE SHEET
AS AT 31 MARCH 2007
Notes 2007 2006
£000 £000
Fixed assets
Intangible assets 1,262 1,360
Tangible assets 472 240
1,734 1,600
Current assets
Stocks 89 140
Debtors: amounts falling due within one year 374 1,304
Cash at bank 1,480 2,716
1,943 4,160
Creditors: amounts falling due within one (520) (508)
year
Net current assets 1,423 3,652
Total assets less current liabilities 3,157 5,252
Creditors: amounts falling due after more (195) (144)
than one year
Net assets 2,962 5,108
Capital and reserves
Called up share capital 9,526 9,525
Other reserve (2,003) (2,003)
Profit & Loss account (4,561) (2,415)
Equity shareholders' funds 2,962 5,108
CONSOLIDATED CASH FLOW STATEMENT
FOR THE YEAR ENDED 31 MARCH 2007
Notes 2007 2006
£000 £000
Net cash outflow from operating activities 4 (904) (1,189)
Returns on investment and servicing of finance
Interest received 109 142
Taxation
Research and development tax credits received - (99)
Capital expenditure and financial investment
Purchase of tangible fixed assets (420) (119)
Net cash outflow from capital expenditure and (420) (119)
financial investment
Cash outflow before management of liquid resources (1,215) (1,265)
and financing
Management of liquid resources
Cash released from short term deposit 1,592 1,658
Increase in cash in year 377 393
NOTES TO THE FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 MARCH 2007
1 PRINCIPAL ACCOUNTING POLICIES
The financial statements have been prepared in accordance with applicable United
Kingdom Accounting Standards, up to and including Financial Reporting Standard
('FRS') 28. A summary of the more important Group accounting policies, which
have been applied consistently, is set out below. The principal accounting
policies represent the most appropriate in accordance with FRS 18.
The summary accounts set out above do not constitute statutory accounts as
defined by Section 240 of the UK Companies Act 1985. The summarised consolidated
balance sheet at 31 March 2007, the summarised consolidated profit and loss
account and the summarised consolidated cash flow statement for the year then
ended have been extracted from the group's statutory accounts for the year to 31
March 2007 upon which the auditors' opinion is unqualified. The statutory
accounts for the year ended 31 March 2007 were approved by the Directors on
6 September 2007, but have not yet been delivered to the Registrar of Companies.
2 SEGMENTAL ANALYSIS BY CLASS OF BUSINESS AND GEOGRAPHICAL AREA
a) Class of business - The Group operates one class of business
b) Geographical area- The analysis by geographical area of the Group's
turnover, loss before tax and net assets is set out below:
Turnover 2007 2006
sales by sales by sales by sales by
destination origin destination origin
£000 £000 £000 £000
Geographical segment
United Kingdom 8 - 36 -
Rest of Europe - - - -
Rest of World 268 276 1,389 1,425
276 276 1,425 1,425
3 LOSS PER ORDINARY SHARE
The basic loss per ordinary share is calculated on the loss of the Group of
£2,121,321 (2006: loss of £523,348) and on 3,810,278 (2006: 3,810,278) equity
shares, being the weighted average number of shares deemed to be in issue. The
exercise of share options would not have been dilutive and accordingly the basic
and diluted loss per share are the same.
4 RECONCILIATION OF OPERATING LOSS TO NET CASH FLOW FROM OPERATING
ACTIVITIES
2007 2006
£000 £000
Group operating loss (2,230) (665)
Amortisation of intangible fixed assets 133 99
Depreciation of tangible fixed assets 96 72
Loss on sale of fixed assets 53 -
Decrease / (Increase) in stocks 51 (71)
Decrease / (Increase) in debtors 930 (1,027)
Increase in creditors 63 403
Net cash outflow from operating activities (904) (1,189)
5 NOTICE OF ANNUAL GENERAL MEETING
Notice is hereby given that the tenth Annual General Meeting of AorTech
International plc will be held at the offices of The Hogarth Partnership, 2nd
Floor Upstream, No.1 London Bridge, London SE1 9BG on 2 October 2007 at 10:00am.
6 POSTING AND AVAILABILITY OF ACCOUNTS
The annual report and accounts for the year ended 31 March 2007 will be sent by
post to all registered shareholders on 6 September 2006. Additional copies will
be available for a month thereafter from the Company's Surbiton office.
Alternatively, the document may be viewed on, or downloaded from, the Company's
website: www.aortech.com.
This information is provided by RNS
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