Final Results
Aortech International PLC
31 August 2006
31 August 2006
Final Results for the year ended 31 March 2006
AorTech International plc (AIM: AOR) ('AorTech' or the 'Company'), the medical
device development and biomaterials intellectual property and licensing company,
today announces its final results for the year ended 31 March 2006.
Operational Highlights
• First US FDA Pre-Market Approval ('PMA') for use of Elast-Eon(TM) in a
long-term life sustaining application
• Agreement signed with St Jude Medical for exclusive use of Elast-Eon(TM)
as cardiac rhythm management lead insulator
• Expansion and relocation of Australian facility:
o increased scale and stability of pilot polymer synthesis manufacturing
capability
o reduced manufacturing costs
• Appointment of Eddie McDaid and Gordon Wright as Non-Executive Directors
Post period end:
• First human use of Elast-Eon(TM) in cardiac lead insulators achieved in July
• Appointment of Medical Advisory Board comprising two highly esteemed plastic
surgeons and researchers
Financial Highlights
• Turnover up over 900% to £1.42m (2005: £0.14m), of which £1.1m resulted
from agreement signed with St Jude Medical
• Operating expenses reduced by 15% to £1.87m (2005: £2.19m)
• Loss after tax reduced by 72% to £0.52m (2005: Loss £1.87m)
• Net cash position of £2.72m (2005: £4.02m), reflecting investment in
development projects
Commenting on the results, Jon Pither, Chairman of AorTech, said:
'The positive results of the year are a culmination of the efforts of the past
three years. These efforts have enabled the Company to focus on realising the
potential of its Elast-Eon(TM) material and to deliver the first major
commercialisation of Elast-Eon(TM) in a medical device product through our
licence and supply agreement with St. Jude. Having achieved this first
commercialisation agreement I am confident that this will be the first of
several licence and supply agreements over the coming years. Our Company is now
achieving a financial and cash flow stability that we have been seeking to
create since 2003.'
-Ends-
Enquiries:
AorTech International plc Tel: 020 7357 9477 (on 31 August)
Frank Maguire, CEO
Hogarth Partnership Limited Tel: 020 7357 9477
Melanie Toyne-Sewell / Sarah Richardson
Notes to Editors:
AorTech International plc is a public limited company formed under the laws of
Scotland, UK and is traded on the Alternative Investment Market, a market
operated by the London Stock Exchange plc, under the trading symbol AOR.
Additional material concerning AorTech International is available on the
Company's website at www.aortech.com, or may be obtained by contacting the
Company's Public Relations firm, Hogarth Partnership Limited.
AorTech International plc: Prestige Travel Suite, Barclays Bank House, 81-83
Victoria Road, Surbiton, Surrey, KT6 4NS, UK
Chairman's statement
Financial year ended 31 March 2006 saw the first significant income for the
biomaterials-focused business strategy that has been under development since
2003.
Results
Results to date are reflected in the summary financial performance of the
business:
For the year ended 31 March 2006, the Company's turnover was £1,424,944,
representing a more than 10-fold increase over the previous year's £136,958.
Approximately £1.1million of the 2006 turnover resulted from the agreement
signed with St. Jude Medical. As the substance of the transaction is that of a
sale of rights to the use of Elast-Eon(TM) in specified fields of use, this has
been recognised as revenue in these financial statements. Operating expenses for
the year were £1,867,740, representing a reduction of almost 15% over the
previous year and being 26% less than the figure for 2004. The operating
expenses included £634,292 of development expenditure (2005: £653,896) and
amortisation of intangible fixed assets of £99,491 (2005: £94,589). The Loss
after Tax for the year was £523,348, which compares with the loss for 2005 of
£1,867,390.
The cash position as at 31 March 2006 was £2,715,804, which compares with
£4,015,126 on the corresponding day in 2005. However, the cash position improved
significantly in April 2006 with the receipt of the US$2million (approximately
£1.1million) initial payment from St. Jude Medical in respect of the agreement
concluded prior to the financial year end.
Other tangible measures of progress came in the form of the first US FDA
Pre-Market Approval ('PMA') for the use of our Elast-Eon(TM) material in a
long-term, life sustaining application and the agreement reached with St. Jude
Medical for exclusive use of Elast-Eon(TM) as insulation for its cardiac pacing
products. Post year end, an extremely important event occurred in July 2006 when
Elast-Eon(TM) achieved first human use as a cardiac rhythm management lead
insulator.
Our general strategy is to build a profitable, cash positive, polymer licensing
and supply business and to leverage that base with selected device development
projects with high potential returns, such as heart valve and breast implant,
with which the directors expect to enhance shareholder value.
Elast-Eon(TM) licensing and supply
As FDA approval of our product became known in the marketplace and our contract
with St. Jude Medical was announced, there was a substantial increase in new
customer enquiries.
Almost any clinical use of our polymer requires a lengthy cycle of application
development and testing followed by a regulatory approval phase. However, as a
consequence of PMA approvals and first human use, customer interest has risen
and we anticipate an increasing number of clinical applications to be approved
during the coming financial year. We would expect these to be focused mainly on
orthopaedic and cardiac surgery applications, although there are additional
client development programmes underway in cardiology and urology, among others.
During the period, under the guidance of our Chief Scientific Officer, Dr. Ajay
Padsalgikar, we also continued to expand our technology offerings with the
development of new softer grades of Elast-Eon(TM), an Elast-Eon(TM) gel and an
injectable form of Elast-Eon(TM). Patent applications have been made for all of
these materials.
Device Development
The two most significant internal projects I wish to report on are the polymer
heart valve and the breast implant.
Polymer heart valve
The global prosthetic heart valve market is in excess of $1 billion and growing
at approximately 6% per annum. Various estimates suggest that the potential
market for percutaneous heart valves is equivalent in size to the surgical heart
valve market.
Over the past several years, Bovine Spongiform Encephalopathy (BSE) has emerged
as a risk factor in the use of tissue heart valves manufactured from animal
tissue. A polymer heart valve removes this risk.
There has been increased interest from both industry and investors in
catheter-delivered (percutaneous) heart valve technology. A percutaneous heart
valve has the advantage of being delivered to the heart via a catheter inserted
through an incision in the groin, thus avoiding conventional open-chest surgery
utilising cardio-pulmonary bypass. This approach provides a therapeutic option
for patients not strong enough to undergo a conventional open-chest procedure.
The AorTech polymer valve offers significant advantages in size and ease of use
as compared with other, tissue-based percutaneous designs, making this therapy
available for smaller patients. The strength of this increased industry interest
in catheter-delivered heart valves can be demonstrated by the Edwards
Lifesciences' acquisition in October 2004 of Percutaneous Valve Technology
Company (PVT), for a reported $125million up front payment.
The AorTech polymer valve offers a significant advantage in manufactured cost
versus other commercially available heart valve products, making it ideally
suited for large emerging markets such as China and India.
AorTech's Strategy: Prior to suspending our UK based heart valve development
programme in the summer of 2003, two key objectives were attained.
These were the filing of patents for the 'high durability' polymer valve known
as M-95-C in both surgical and percutaneous forms and the demonstration of a
soft failure mode for this valve. This 'soft' failure mode is similar, and our
data suggests even somewhat superior, to that of commercial tissue heart valve
products in widespread distribution. The significance of a soft failure mode is
that, unlike a mechanical valve where failure almost always results in death, a
patient with a failing polymer or tissue valve will exhibit symptoms of the
failing valve, providing an opportunity for an intervention to correct this
situation, thus preserving the life of the patient.
As a result of these technology and market factors there has been a general
level of renewed interest by outside parties in our AorTech polymer valve. This
interest level has been significant and has led to our decision to recommence
the AorTech polymer valve programme. We have recruited Dr. Jason Beith, the
inventor of the recently patented M-95-C valve to lead our development project
team.
We are seeking an industry partner to assist in the development programme and
believe that we have made progress towards identifying a partner who will
provide the necessary resources to continue the pre-clinical development and
testing on our polymer valve. This would enable the valve project to be taken
successfully to clinical trials in future years with the ultimate objective
being the commercialisation of this heart valve in areas of surgical, minimally
invasive and percutaneous manifestations. I look forward to reporting on the
progress towards a partnership for the development of the AorTech polymer valve
within the next year.
On 26 March 2006 our M-95-C patent was issued in the UK and we anticipate that
it will be issued in all major territories over the next 18-24 months.
Breast Implant
Worldwide, 800,000 women will receive breast implant products in the coming
year. More than 90% of these will be for purely cosmetic reasons.
Although some form of re-approval by US FDA of a silicone gel-filled implant is
anticipated in the near future, we believe that the case for the use of an
Elast-Eon(TM) gel filler in existing implants can be made on the basis of both
product and patient safety. Our product avoids the use of platinum or tin - or
indeed any metal catalyst in the material - and offers a substantive reduction
in low molecular weight compounds compared with the silicone material that
characterises existing silicone breast implant products.
It is our opinion, therefore, that the anticipated US FDA approval of silicone
gel products will be a positive development for AorTech as it will reintroduce a
technology factor into market competition for devices that have been in
regulatory limbo for 14 years.
We have been developing a minimally invasive gel implant technology that we
believe may be of significant interest to both the industry and the market. This
technology will permit a gel implant procedure, without damage to the shell, and
secure the benefits of the safer Elast-Eon(TM) gel. We are not aware of any
other next generation breast implant technology like this. Our future
development programme over the coming months is to pursue proof of concept for
the minimally invasive breast implant and to select a partnership where the
development programme can be taken to clinical trials and ultimately commercial
use. Patents have been filed for this minimally invasive breast implant device.
Operational Update
In May 2006, our Australian operation moved into a new and expanded facility
located on a technology campus in Scoresby, Melbourne, approximately 3 miles
from our prior location.
As a result of this relocation we have been able to both scale up and stabilise
our pilot polymer synthesis manufacturing capability. Together with the
improvement in polymer quality levels, we are able to achieve a significant
reduction in the polymer manufacturing cost.
We anticipate that our new capacity levels are adequate for the foreseeable
future. Substantive funding for the infrastructure elements of this move were
obtained from the Australian State of Victoria. This move is an endorsement of
the success of AorTech's team in Victoria and the quality of local support
available to a high technology business.
Board Changes
In November 2005, we announced the appointment of Eddie McDaid and Gordon Wright
as Non-Executive Directors of the Company. Their knowledge of the Company and
the industry in which we operate is wide ranging, and their input has been much
welcomed by their colleagues on the Board.
Outlook
Over the coming year we expect the early adopters of Elast-Eon(TM) technology in
the fields of cardiology, orthopaedics and urology to provide the momentum for
moving this segment of the business forward. We have prepared our operations for
this new business and are confident of our product quality, capacity of
manufacturing and new cost basis.
During the same period, we expect to be announcing significant developments in
the use of Elast-Eon(TM) in orthopaedic applications and we anticipate the
formation of a co-development partnership with an industry partner for our heart
valve technology.
Current trading remains in line with the Board's expectations.
In Conclusion
The positive results for the year are a culmination of the efforts of the past
three years, following the downsizing of the organisation and its activities
during 2002/2003.
These efforts have enabled the Company to focus on realising the potential of
its Elast-Eon(TM) material and to deliver the first major commercialisation of
Elast-Eon(TM) in a medical device product through our licence and supply
agreement with St. Jude Medical. Having achieved this first commercialisation
agreement I am confident that it will be the first of several licence and
supply agreements over the coming years. Our Company is now achieving a
financial and cash flow stability that we have been seeking to create since
2003.
None of this progress or these achievements would have been possible without the
expertise, drive and commitment of our employees in Australia, whom I thank, on
behalf of myself and the Board, for their outstanding service. I have to also
thank my fellow Board members and in particular our Chief Executive, Frank
Maguire, for his sterling work during the past twelve months in delivering the
positive results and indeed the major turnaround that the Company has achieved
during the year ended 31 March 2006.
Finally, I take this opportunity to thank our shareholders for their continued
support over the years. I am confident that AorTech can build on its
achievements of the past twelve months and that the potential of our unique
Elast-Eon(TM) material will continue to add value to the company over ensuing
years.
Jon Pither
Chairman
Consolidated Profit And Loss Account for the year ended 31 March 2006
Notes 2006 2005
£ £
Turnover 2 1,424,944 136,958
Cost of Sales 3 (222,751) (31,339)
---------- ----------
Gross profit 1,202,193 105,619
Net operating expenses 3 (1,867,740) (2,189,908)
----------------------------------------- ------ ---------- ----------
Net operating expenses include:
Development expenditure (634,292) (653,896)
Amortisation of intangible assets (99,491) (94,589 )
----------------------------------------- ------ ---------- ----------
Group operating loss 3 (665,547) (2,084,289)
Interest receivable 142,199 216,899
---------- ----------
Loss on ordinary activities before taxation 2 (523,348) (1,867,390)
Taxation 5 - -
---------- ----------
Loss for the financial year (523,348) (1,867,390)
========== ==========
Loss per ordinary share 6
Basic (13.74p) (49.01p)
Diluted (13.74p) (49.01p)
Consolidated Statement of Total Recognised Gains and Losses for the year ended
31 March 2006
2006 2005
£ £
Loss for the financial year (523,348) (1,867,390)
Currency translation differences arising on
consolidation (22,981) (45,215)
---------- ----------
Total losses recognised since last annual report (546,329) (1,912,605)
========== ==========
Balance Sheets as at 31 March 2006
Group
2006 2005
£ £
Fixed assets
Intangible assets 1,360,209 1,449,366
Tangible assets 239,775 189,678
Investment in subsidiary undertakings - -
----------- -----------
1,599,983 1,639,044
Current assets
Stocks 139,637 68,852
Debtors: amounts falling due within one year 1,304,424 278,948
Debtors: amounts falling due after more than one year - -
Cash at bank 2,715,804 4,015,126
----------- -----------
4,159,865 4,362,926
Creditors: amounts falling due within one year (508,371) (348,460)
----------- -----------
Net current assets 3,651,494 4,014,466
Total assets less current liabilities 5,251,478 5,653,510
Creditors: amounts falling due after more than one
year (144,297) -
----------- -----------
Net assets 5,107,181 5,653,510
=========== ===========
Capital and reserves
Called up share capital 9,525,695 9,525,695
Other reserve (2,003,143) (2,003,143)
Profit and loss account (2,415,371) (1,869,042)
----------- -----------
Equity shareholders' funds 5,107,181 5,653,510
=========== ===========
Consolidated Cashflow Statement for the year ended 31 March 2006
notes 2006 2005
£ £
Net cash outflow from operating activities 7 (1,188,804) (2,119,791)
Returns on investment and servicing of
finance
Interest received 142,199 216,899
Taxation
Research and development tax credits refunded (98,899) -
Capital expenditure and financial investment
Purchase of tangible fixed assets (119,759) (28,000)
--------- ---------
Net cash outflow from capital expenditure and
financial investment (119,759) (28,000)
Cash outflow before management of liquid
resources and financing (1,265,263) (1,930,892)
Management of liquid resources
Cash released from short term deposit 1,658,461 1,994,364
--------- ---------
Increase in cash in the year 393,198 63,472
========= =========
Notes to the Financial Statements for the year ended 31 March 2006
Note 1
This statement has been prepared using accounting policies and presentation
consistent with those applied in the preparation of the statutory accounts of
the Group. The principal accounting policies represent the most appropriate in
accordance with FRS 18. The new standards that are appropriate to the Group
(namely FRSs 21, 22, 25 and 28) had no material impact on the financial
statements.
The summary accounts set out above do not constitute statutory accounts as
defined by Section 240 of the UK Companies Act 1985. The summarised balance
sheet at 31 March 2006, 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 2006
upon which the auditors' opinion is unqualified. The statutory accounts for the
year ended 31 March 2006 were approved by the Directors on 30 August 2006, but
have not yet been delivered to the Registrar of Companies.
Note 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:
(i) Turnover 2006 2005
Sales by Sales by Sales by Sales by
destination origin destination origin
£ £ £ £
Geographical
segment
United Kingdom 35,870 - 13,024 -
Rest of World 1,389,074 1,424,944 123,934 136,958
--------- --------- -------- --------
1,424,944 1,424,944 136,958 136,958
========= ========= ======== ========
(ii) (Loss) /
Profit before
taxation 2006 2005
£ £
Geographical
segment
United Kingdom (689,206) (957,192)
Rest of World 23,659 (1,127,097)
-------- --------
Loss before interest (665,547) (2,084,289)
Net interest
receivable 142,199 216,899
-------- --------
Loss on ordinary
activities before
taxation (523,348) (1,867,390)
======== ========
(iii) Net assets 2006 2005
£ £
Geographical segment
United Kingdom 2,127,732 3,733,878
Rest of World 2,979,449 1,919,632
--------- ---------
5,107,181 5,653,510
========= =========
Note 3: Net operating expenses
Net operating expenses of £1,867,740 (2005: £2,189,908) also include Selling and
Marketing Costs of £243,739 (2005: £185,384) and Other Administrative Expenses
of £890,218 (2005: £1,256,039).
Note 4: Operating Loss
2006 2005
£ £
The operating loss is stated after charging:
Depreciation and amortisation charge for the year:
Intangible owned assets 99,491 94,589
Tangible owned fixed assets 72,406 70,948
Operating lease rentals:
Other 90,931 138,689
The above results for the year relate to continuing operations.
Note 5: Taxation
No tax arises on the loss for the year (2005: nil)
Unrelieved tax losses remain available to offset against future taxable profits
of the same trade in the same country. These losses have not been recognised as
deferred tax assets within the financial statements as they do not meet the
conditions required in accordance with FRS 19. Losses carried forward in the UK
total £2,401,144 - tax effect is £720,343 (2005: £1,840,679 - tax effect is
£552,204). Losses carried forward in Australia total £4,304,906 - tax effect
£1,291,472 (2005: £4,404,615 - tax effect £1,321,384).
Note 6: Loss per Ordinary Share
The basic loss per ordinary share is calculated on the loss of the Group of
£523,348 (2005: loss of £1,867,390) and on 3,810,278 (2005: 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.
Note 7: Reconciliation of Operating Loss to Net Cash Flow from Operating
Activities
2006 2005
£ £
Group operating loss (665,547) (2,084,289)
Amortisation of intangible assets 99,491 94,589
Depreciation of tangible fixed assets 72,406 70,948
Increase in stocks (70,785) (20,199)
Increase in debtors (1,027,476) (91,100)
Increase / (decrease) in creditors 403,107 (89,740)
--------- ---------
Net cash outflow from operating activities (1,188,804) (2,119,791)
========= =========
Note 8: Notice of Annual General Meeting
The Annual General Meeting will be held at 12 noon on 28 September 2006 at the
offices of Biggart Baillie, Dalmore House, 310 St Vincent Street, Glasgow G2
5QR.
Note 9: Posting and availability of accounts
The annual report and accounts for the year ended 31 March 2006 will be sent by
post to all registered shareholders on 5 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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