Final Results
Aortech International PLC
23 May 2001
AORTECH INTERNATIONAL PLC
Preliminary Results for the Year Ended 31 March 2001
Aortech International plc, the Scottish-based manufacturer of cardio-vascular
devices, announces its Preliminary Results for the year ended 31 March 2001.
Highlights
* Year of continued progress
* Turnover increased 17% to £4.1 million
* Loss for the year £6.2 million - in line with expectations, reflecting
increased marketing & development expenditure
* TruCCOMS - CE mark secured; initial sales made
* Elast-Eon - Supply and Licence Agreement with JOMED signed
* Post year end
- £20m fundraising completed; operations now fully funded for over 2
years
- TruCCOMS - distribution agreement signed
Gordon Wright, Chairman, commented:
'The past year has seen continued progress on all of AorTech's activities both
for our established products and our new technologies. We are pleased to
report increased sales in our established products.
Since the year end, we have concluded a further fund raising thereby providing
the additional resources for the Group to continue its development programme,
to commercialise certain products and to commence clinical trials of our
innovative technologies.
The continued successful development of our outstanding new technologies,
TruCCOMS, the new Tri-Leaflet Heart Valve and the Elast-Eon Material will, we
are confident, deliver long-term growth for Aortech and its shareholders.'
23 May 2001
ENQUIRIES:
Aortech International plc Tel: 01698 746 699
Eddie McDaid, Chief Eecutive
Bell Lawrie White & Co Tel: 0141 221 7733
Clive Thomson / Elizabeth Kennedy
Nomura International plc Tel: 020 7521 2000
David Porter
College Hill Tel: 020 7457 2020
Michael Padley / Nicholas Nelson
Chairman's and Chief Executive's Joint Statement
The past year has seen continued progress on all of AorTech's activities both
for our established products and our new technologies. We are pleased to
report increased sales of our established products from the preceding year
relating primarily to our bio-prosthetic tissue heart valves together with the
initial sales of our new Continuous Cardiac Output Monitoring System
(TruCCOMS) which commenced in the last three months of the financial year. The
increased sales of bio-prosthetic valves reflect the shift in the replacement
heart valve market from mechanical valves to bio-prosthetic (tissue) valves
throughout the World. It is anticipated that there will be significant growth
in AorTech's sales during the course of the current financial year with a
further increase in our bio-prosthetic valves expected and an initial full
year contribution of our TruCCOMS system.
The continued successful development of our outstanding new technologies,
TruCCOMS, the New Tri-leaflet Heart Valve and the Elast-Eon Material will, we
are confident, deliver long-term growth for AorTech and its shareholders.
Since the year end, we have concluded a further fund raising of approximately
£20 million gross which will provide the additional resources for the Group to
continue to deliver progress on our innovative technologies. Sadly adverse
stock market conditions in the early part of the year made it impossible to
complete a larger fund raising in March of approximately £64 million which
would have allowed us to fully commercialise our new products and seek
complementary acquisitions.
TruCCOMS Technology
European regulatory authorities approved the CE Mark for our TruCCOMS
technology in August 2000 after successful clinical trials in patients. Two
papers have already been presented on the clinical results, from patients in
the United Kingdom and a further paper submitted for presentation at the
American Society for Anaesthesiologist in October, 2000 from patient results
in the USA. These papers demonstrated the safety and reliability results of
TruCCOMS. There are and will continue to be ongoing studies for TruCCOMS in
various hospitals throughout the World and we are confident that the results
of these studies will assist the marketing of the product over the ensuing
years.
Full marketing and sales of TruCCOMS commenced in the last quarter of the
financial year and the results of these sales are encouraging with the
acceptance of the device by surgeons and anaesthetists in patient management
during and after surgery. Early results have in particular demonstrated the
additional benefits which TruCCOMS provides for patients having open heart
surgery on their 'beating hearts', known as 'off pump surgery'. During these
critical operations the TruCCOMS monitor provides surgeons and anaesthetists
with the ability to determine changes in patients' cardiac output immediately
and to take the necessary corrective action, thus providing improved patient
management.
Several key European Centres have adopted the TruCCOMS technology including
one of the major hospitals in Germany where the system is being used during
routine coronary artery bypass (CABG surgery) and in Italy during coronary
artery bypass grafting where patients are undergoing 'off-pump surgery.' The
immediate response of TruCCOMS to changes in patients' cardiac output enables
surgeons to monitor the success of the coronary grafts as they are completed.
We have announced the signing of a Distribution Agreement with Becton
Dickinson, one of the world's leading medical device companies, for
distribution of TruCCOMS initially throughout Europe and the Middle East. This
Agreement is clear evidence of the future marketing and sales potential of
TruCCOMS.
There are ongoing studies in both the USA and Europe in respect of the use of
the TruCCOMS technology during angioplasty procedures i.e. procedures for
elimination of areas of narrowing in blood vessels. The purpose of these
studies is to show that TruCCOMS can allow physicians to determine the
potential success of angioplasty procedures as they are being carried out. The
studies will continue and, if successful, would represent a major new
application for our technology in this significant market area.
New Tri-leaflet Heart Valve
Our Tri-leaflet Heart Valve will soon reach the stage of regulatory testing
that is required prior to the clinical trials in patients which are
anticipated to commence in mid 2002.
Continued progress has been achieved during the past twelve months with
several versions of the valves reaching critical durability levels in excess
of 600 million cycles corresponding to approximately 15 years in patients.
This is the number of cycles, under regulatory conditions, required by the FDA
prior to approval for patient trials in the USA. A further paper was presented
at the American BioMaterials Conference in Minneapolis in April 2001
demonstrating the excellent results from explanted valves. In addition, the
paper previously presented at the European Association of Artificial Organs
Congress in Switzerland in September 2000 has subsequently been published in
the International Journal of Artificial Organs.
Elast-Eon Material
The Elast-Eon material is continuing to be evaluated by a number of medical
device companies for utilisation in a range of medical device applications. In
January we concluded a Supply and Licence Agreement with JOMED, a major
European cardiovascular device company focusing on the manufacturing and sales
of stents which are utilised during certain angioplasty procedures by
insertion within the vessel to maintain patency. One of the objectives of
medical companies involved in the stent market (which is approximately £1.5
billion) is to reduce the restenosis i.e. the re-narrowing or contraction of
the vessel or artery. Having evaluated and assessed
Elast-Eon over the past 18 months, it is JOMED's aim to utilise the material
to improve the performance of its stents and reduce the restenosis rates.
With the number of Evaluation Agreements presently in place we are confident
that further Supply and Licence Agreements will be completed during the course
of this financial year. The continued positive results of Elast-Eon within our
new heart valve project demonstrates the unique properties of the material,
and in particular its outstanding biostability.
The Group's facility in Melbourne has been expanded to incorporate the
additional personnel and equipment required to increase production and we are
pleased to report that this facility has recently received confirmation of its
ISO 9001 manufacturing accreditation. This is an important step in the
development and progress of the AorTech Biomaterials Division, which we
anticipate will have significant long term potential for AorTech.
Executives and Staff
The continued progress of AorTech can only be sustained with the commitment of
all of our employees within the Group and we shall continue to build on the
professional and quality staff which we have at present to ensure the Group
capitalises on its outstanding range of technologies.
New Senior Appointments
We are pleased to confirm the appointment of the following Senior persons:-
Jonathan Brooks, Non-Executive Director
Graham McKay, Development Director
Paul Burns, Quality and Regulatory Director
Jonathan Brooks was appointed a Non-Executive Director of the company in
February 2001 and is a member of the company's Audit, Remuneration and
Nomination Committees. Jonathan is Chief Financial Officer of ARM Holdings
plc, a company quoted on both the London Stock Exchange and NASDAQ. Jonathan
will provide additional experience and further strengthens AorTech's Board of
Directors.
There has been significant expansion in the project teams within our new
facilities in Scotland including the appointments of Graham McKay as
Development Director and Paul Burns as Quality and Regulatory Director. Graham
was Director of New Product Development for SSL International and prior to
that was Business Development Manager and Technical Manager for Johnson &
Johnson. He has twenty years' experience in biomaterials and medical products.
Paul Burns has in excess of fifteen years' experience in the medical device
sector, his most recent position being Quality Assurance and Regulatory
Affairs Manager for Sulzer Vascutek Limited, a wholly owned subsidiary of
Sulzer Medica, a major global medical device company.
Scientific Advisory & Medical Advisory Group
The company established, in November 2000, a Scientific Advisory Group and a
Medical Advisory Group.
The aim of the Scientific Advisory Group is to assist the Company in the
resolution of important scientific and technological issues and the
identification of opportunities for further developments based upon AorTech's
new technologies and core competencies. The members of the Group are among the
world's leading authorities in their various fields.
The Medical Advisory Group, whose members are physicians and surgeons of
international renown, has been set up with the aim of assisting and providing
medical advice to AorTech on various clinical issues in relationship to our
products and technologies as we bring them forward from the development phase
to the regulatory phase and into clinical trials in patients.
Future Prospects
We have, in common with our shareholders, been disappointed at the decrease in
the share price and market capitalisation of the Group. It is, however,
important to recognise that the underlying technologies and projects have
continued to progress; that regulatory work will be commencing in the very
near future on the new heart valve project; that marketing and sales of
TruCCOMS have commenced; and that the first Supply and Licence Agreement has
been concluded on Elast-Eon.
We are confident that the continued progress on all of our technologies during
the current year will be maintained and accelerated and therefore there should
be further growth and value to the AorTech Group.
We thank all of our Directors and employees throughout the Group for their
significant contribution over the past year but in particular thank our
Shareholders for their forbearance, understanding and in particular their
continued support for the Group which was demonstrated by their participation
in the recent successful fund raising.
Eddie McDaid Gordon Wright
Chief Executive Chairman
Consolidated Profit and Loss Account
Note 2001 2000
£ £
Turnover 2 4,050,585 3,452,246
Cost of sales (2,004,486) (1,359,304)
Gross profit 2,046,099 2,092,942
Selling and marketing costs (1,065,257) (744,627)
Administrative expenses (7,953,999) (3,096,390)
Administrative expenses include:
Development expenditure (4,626,361) (1,476,626)
Amortisation of intangible fixed (1,235,148) (162,093)
assets
Group operating loss (6,973,157) (1,748,075)
Share of operating loss of associate - (85,128)
Loss on operating activities before (6,973,157) (1,833,203)
interest
Interest receivable 785,838 113,911
Interest payable (25,755) (45,189)
Loss on ordinary activities before and (6,213,074) (1,764,481)
after taxation
Loss per ordinary share
Basic 3 (20.71p) (7.71p)
Diluted (20.71p) (7.71p)
Statement of Total Recognised Losses
Loss for the financial year (6,213,074) (1,764,481)
Currency translation differences arising (211,990) (2,020)
on consolidation
Total recognised losses relating to the (6,425,064) (1,766,501)
year
Prior year adjustment 4 - (919,193)
Total losses recognised since last report (6,425,064) (2,685,694)
Consolidated Balance Sheet
2001 2000
£ £
Fixed Assets
Intangible Assets 22,137,882 23,540,817
Tangible Assets 2,535,126 1,252,521
24,673,008 24,793,338
Current Assets
Stocks 2,165,530 1,957,466
Debtors 3,369,254 1,583,860
Cash at Bank 8,325,970 16,032,106
13,860,754 19,573,432
Creditors: amounts falling due within one year (2,377,592) (2,371,631)
Net Current Assets 11,483,162 17,201,801
Total Assets less Current Liabilities 36,156,170 41,995,139
Creditors: Amounts falling due after more than - (364,472)
one year
Accruals and Deferred Income (139,734) (78,329)
Net Assets 36,016,436 41,552,338
Capital and Reserves
Called Up Share Capital 7,547,341 7,284,841
Share Premium Account 42,160,934 41,534,272
Other Reserve (2,003,143) (2,003,143)
Profit and Loss Account (11,688,696) (5,263,632)
Equity Shareholders' Funds 36,016,436 41,552,338
Consolidated Cash Flow Statement
Note 2001 2000
£ £
Net cash outflow from operating (5,096,432) (2,084,253)
activities
Returns on investment and servicing of 812,130 58,522
finance
Capital expenditure and financial (1,917,169) (2,016,897)
investment
Acquisitions and disposals - (822,689)
Cash outflow before management
of liquid resources and (6,201,471) (4,865,317)
financing
Management of liquid resources 7,831,938 (14,879,507)
Financing 5 (1,461,733) 20,320,644
Increase in cash in year 168,734 575,820
Note 1
The financial information set out in this Announcement has been abridged from
the Annual Report for the year ended 31 March 2000 and the unaudited accounts
for the year ended 31 March 2001. The statutory accounts for the year ended 31
March 2000 were reported on by the Auditors, PricewaterhouseCoopers, without
qualification and have 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 in one class of business
(b) geographical area
2001 2000
destination origin Destination origin
£ £ £ £
Geographical segment
United Kingdom 888,922 3,228,063 746,611 2,794,200
Rest of Europe 2,870,108 726,399 2,657,063 658,046
Rest of World 291,555 96,123 48,572 -
4,050,585 4,050,585 3,452,246 3,452,246
Note 3 Loss per ordinary share
The basic loss per ordinary share is calculated on the loss of the group of £
6,213,074 (2000 - £1,764,481) and 29,999,033 (2000 - 22,887,273) equity shares
being the weighted average number of shares deemed to be in issue. The
exercise of stock options would not be dilutive.
Note 4 Prior Year Adjustment - Year ended 31 March 2000
During the year ended 31 March 2000, the Company changed its accounting policy
on development expenditure. Previously, such development expenditure relating
to specific projects intended for commercial exploitation was carried forward
where the ultimate commercial viability had been assessed with reasonable
certainty. Under the new accounting policy, all development expenditure is
written off as incurred.
The effect of moving to this new policy was to increase the loss for the year
ended 31 March 2000 by £1,561,754. The change of policy also reduced
shareholders' funds by £919,193 as at 1 April 1999.
Note 5 Financing
Financing payments during the year ended 31 March 2001 include £1,023,098
relating to the issue of shares in May 2001.
Copies of this statement will be available for a period of 14 days from the
Company's registered office:
Phoenix Crescent, Strathclyde Business Park, Bellshill, Scotland, ML4 3NJ.