Interim Results - 6 Months to 30 September 1999
Aortech International PLC
15 December 1999
Interim Results for the Six Months Ended 30 September 1999
AorTech International plc, the Scottish-based manufacturer
of cardio-vascular devices, announces its Interim Results
for the six months ended 30 September 1999. The Company
continues to achieve its objectives and has made significant
progress in the past six months.
Highlights
* Turnover increased 30% to £1.62 million; Loss for the
period reduced to £110,445
* Tissue valve business acquired
* TruCOMMS FDA approval secured
* Additional evaluation agreements for Elast-eon signed
* Trileaflet heart valve design completed
* Funds in place to meet current working capital
requirements
Gordon Wright, Chairman, commented:
'A sharp increase in sales of Tissuemed heart valves
contributed to the overall increase in sales and we
anticipate further growth during the remainder of the
current financial year. Sales of the Mitral Repair System
have been very encouraging and the manufacturing agreement
with Novoste Inc continues to provide a valuable source of
revenue.
'The last six months has been a period of progress, growth
and continued development of AorTech and your Directors
expect that the next twelve months will produce further
significant opportunities.
'We are particularly excited about the continued good
results from our trileaflet heart valve development and look
forward to the commencement of clinical trials in patients
in 2001.'
15th December 1999
ENQUIRIES:
AorTech International plc Tel: 01698 746699
Eddie McDaid, Managing Director
Bell Lawrie White & Co. Tel: 0141 221 7733
Clive Thomson / Elizabeth Kennedy
College Hill Tel: 0171 457 2020
Michael Padley / Nicholas Nelson
CHAIRMAN'S AND MANAGING DIRECTOR'S STATEMENT
The six month period has seen truly significant advances in
all of AorTech's main activities and we are particularly
pleased that the long term significance of these
achievements is increasingly being recognised by investors.
The value that the Market is now placing upon AorTech is a
tangible endorsement of the Directors' confidence in the
Company's excellent prospects in the global medical device
market.
The highlights of this period have been:
* Acquisition of the tissue valve manufacturing business
and related patents of Tissuemed Limited.
* Conclusion of agreements to secure ownership of the
intellectual property for the innovative TruCCOMS cardiac
monitoring system.
* FDA regulatory approval for TruCCOMS, allowing marketing
in the USA.
* Completion of the design for the new synthetic trileaflet
heart valve.
* Durability tests on the trileaflet valve passing 300
million cycles (equivalent to 7.5 years in patients).
* Further evaluation agreements for Elast-eon biomaterials
entered into by Elastomedic.
Results for the Period and Financial Position
We are pleased to report a further increase in the Company's
turnover for the six month period to 30 September 1999 to
£1,619,266 which represents an increase of approximately 30%
over the same period last year. The pre tax loss of £110,000
represents a significant decrease, of approximately
£165,000, compared to the same period last year. This is a
result of increased sales and improvement in gross margins.
A sharp increase in sales of Tissuemed heart valves
contributed to the overall increase in sales and we
anticipate further growth during the remainder of the
current financial year following the recent acquisition of
this business.
During the period, AorTech concluded a distribution deal
with MEDOS in Germany for both Tissuemed and Ultracor
valves. Sales of the Mitral Repair System have been very
encouraging and the manufacturing agreement with Novoste Inc
continues to provide a valuable source of revenue and
recognition of the Company's manufacturing and quality
control procedures.
It is anticipated that the turnover for the six month
period to 31 March 2000 will show further growth over the
period to 30 September 1999.
As at 30 September 1999 the Company had cash resources in
excess of £2 million. These resources are sufficient to
complete the initial commercialisation of the TruCCOMS
system and to meet our current working capital requirements.
Tissuemed
On 1 September 1999, the Company acquired the heart valve
division of Tissuemed Limited for £800,000 in cash with a
further £200,000 deferred consideration related to
performance. This was partly funded by a Placing of 141,000
shares which raised £500,000. Prior to this acquisition, the
Company had exclusive worldwide distribution rights in
respect of Tissuemed's heart valves. The acquisition means
that AorTech now has ownership of a range of both mechanical
and tissue heart valve replacements. The tissue valve market
is showing significantly more growth than the mechanical
valve market and this acquisition ensures that AorTech is
well placed to take advantage of this growth.
TruCCOMS
On 30 July 1999 we announced that we had concluded
agreements to secure rights to the intellectual property,
including the USA patents for the innovative TruCCOMS
cardiac monitoring system. In our view this system
represents a major breakthrough in the monitoring of
patients' cardiac output both during and after surgery. The
system, which consists of a disposable catheter linked to an
analytical and display monitor, provides an immediate
response and continuous monitoring of cardiac output and
addresses shortcomings in current clinical assessment
technology during surgical procedures and in intensive care.
Development work has been carried out and completed during
the last 21 months and the first phase of clinical trials in
Papworth Hospital in England confirmed the accuracy and
immediate response of the system. Market enquiries indicate
that TruCCOMS will provide improved patient management
information, which is not currently available to surgeons,
anesthetists, cardiologists and critical care specialists.
The final phase of clinical trials of TruCCOMS commenced in
mid-September and should be concluded in the early part of
2000.
On 4 November 1999, we announced that US regulatory approval
had been obtained for TruCCOMS. The achievement of the Food
& Drug Administration approval allows us to market the
system in the USA and the Directors anticipate that the
technology will be ready to enter intensive care units and
operating theatres during the first quarter of the year
2000. European regulatory approval is anticipated during the
early part of next year. We believe that the present
worldwide thermal dilution catheter market of approximately
US$200 million per annum will increase with the introduction
of our new system. It is intended to manufacture TruCCOMS at
the Company's facility in Scotland.
AORTECH INTERNATIONAL PLC
Interim results for the six months ended September 1999
The acquisition of the intellectual property together with
the development of TruCCOMS to date through to clinical
trials represents a major breakthrough by the Company.
TruCCOMS will, your Directors believe, continue to
contribute towards real growth in shareholder value.
A Placing which raised £2.88 million was concluded in August
1999. This raised funds to complete the acquisition of the
TruCCOMS system, finalise the development and clinical
trials of the system and for its initial commercialisation.
New Synthetic Trileaflet Heart Valve
Our new synthetic trileaflet heart valve is considered by
the Directors to represent the major development in heart
valve replacement during the last 25 years. The purpose of
this new valve is to overcome the major problems of all
current replacement heart valves namely the requirement of
patients to take daily anti-coagulants in the case of
mechanical valves and the relatively short life span (6-10
years) of tissue valves.
We are pleased to confirm that the design of the new
synthetic trileaflet heart valve has been completed and that
full patent filings in all countries considered
strategically important by the Directors were made in June
1999. The design of the new valve has met all key tests to
date and continuous simulated durability trials are still
progressing. Our valves have already achieved critical
durability levels of 300 million cycles in testing,
representing 7.5 years in patients. Home Office approval
has been granted for the first phase of in-vivo testing of
the valves and this has now commenced with valves being
implanted in sheep in November 1999. There are further
milestones to be passed relating to the long term durability
and the final results of biostability and biocompatability
in these animal trials. All of the results to date give
your Directors confidence that the final development phase
for this product will result in a new generation of
replacement heart valves suitable for clinical trials in
patients during 2001.
The Directors are aware that major medical device companies
in the US have, over a number of years, sought to develop a
new synthetic heart valve to overcome the current problems
of mechanical valves and tissue valves. We believe,
therefore, that the commencement of clinical trials in
patients in respect of our new valve should have a
significant effect on the share value and market
capitalisation of the Company.
Elastomedic
The decision both to invest in Elastomedic and to obtain
exclusive worldwide rights to the new biomaterials for use
in the synthetic trileaflet heart valve has been fully
justified by the exciting results being achieved. In
addition, Elastomedic has concluded evaluation agreements
with twelve major corporations for use of the material in
other medical devices. The use of the materials in medical
device applications other than heart valves provides, the
Directors believe, opportunities for major growth not only
for Elastomedic but also for AorTech through its investment
in that company.
Future Prospects
The acquisition and development of TruCCOMS, together with
the continued development of the new trileaflet heart valve,
demonstrates our determination not only to expand further
our product base but also to introduce innovative products
to the medical device market with, we believe, significant
profit potential. Obtaining regulatory approval for
TruCCOMS together with the commencement of sales of this
product will have a substantial benefit on the long term
future growth of AorTech.
We are particularly excited about the continued good results
from our trileaflet heart valve development and we look
forward to the progress of this project during the course of
the next twelve months and to the commencement of clinical
trials in patients in 2001. The Directors believe that this
will have a further significant impact on the performance
and future prospects of the Company.
Given the Company's prospects and plans for growth, the
Directors are examining the merits of a range of
stockmarkets on which the Company's shares might be traded.
These include the Official List, with the option of joining
techMARK, and NASDAQ in the USA.
The continued development and progress of AorTech has been
the result of dedication and commitment by all of the
Company's employees, our University partners in the United
Kingdom and our colleagues in Australia. We take this
opportunity to thank all of our team for their outstanding
contribution and also to thank our shareholders for their
continued support.
The last six months has been a period of progress, growth
and continued development of AorTech and your Directors
expect that the next twelve months will produce further
significant opportunities and growth prospects for your
Company.
J G Wright, Chairman
E McDaid, Managing Director
15 December 1999
CONSOLIDATE PROFIT AND LOSS ACCOUNT (UNAUDITED)
Six months ended Year ended
30 September 31March
1999 1998 1999
Note £ £ £
Turnover 2 1,619,266 1,250,435 2,779,315
Cost of sales (644,848) (640,736) (1,239,431)
Gross profit 974,418 609,699 1,539,884
Net operating expenses (1,068,979) (901,300) (1,883,105)
Loss on ordinary activities (94,561) (291,601) (343,221)
before interest
Interest receivable 11,068 48,656 83,385
Interest payable (26,952) (32,084) (60,748)
Loss on ordinary activities
before and after Taxation 2 (110,445) (275,029) (320,584)
Loss per ordinary share 3 (0.5)p (1.4)p (1.6)p
Statement of total
recognised losses
Loss for the period (110,445) (275,029) (320,584)
Currency translation
differences arising on (506) 634 (17)
consolidation
Total recognised losses (110,951) (274,395) (320,601)
CONSOLIDATED BALANCE SHEET (UNAUDITED)
30 September 31 March
1999 1998 1999
£ £ £
Fixed assets
Intangible assets 4,034,196 925,676 1,433,295
Tangible assets 1,014,959 772,169 1,040,170
Investment in associated 761,479 488,896 622,287
undertaking
5,810,634 2,186,741 3,095,752
Current assets
Stocks 1,854,695 1,355,287 1,651,874
Debtors 1,298,400 1,103,548 1,155,550
Cash at bank 2,066,324 1,871,395 576,779
5,219,419 4,330,230 3,384,203
Creditors: amounts falling due (2,054,949) (906,141) (896,581)
within one year
Net current assets 3,164,470 3,424,089 2,487,622
Total assets less current 8,975,104 5,610,830 5,583,374
liabilities
Creditors: amounts falling due (420,875) (478,391) (355,964)
after more than one year
Accruals and deferred income (287,681) (50,000) (199,169)
Net assets 8,266,548 5,082,439 5,028,241
Capital and reserves
Called up share capital 6,015,845 5,081,818 5,081,818
Share premium account 6,942,735 4,535,496 4,527,504
Other reserve (2,003,143)(2,003,143) (2,003,143)
Profit and loss account (2,688,889)(2,531,732) (2,577,938)
Shareholders' funds 8,266,548 5,082,439 5,028,241
AORTECH INTERNATIONAL PLC
Interim results for the six months ended September 1999
CONSOLIDATED CASH FLOW STATEMENT (UNAUDITED)
Six months ended 30 Year ended
September 31 march
1999 1998 1999
Note £ £ £
Net cash outflow from (382,212) (447,333) (816,453)
operating activities
(see below)
Returns on investment and (20,896) 16,572 20,763
servicing of finance
Capital expenditure and (1,334,938) (822,648) (1,638,912)
financial investment
Cash outflow before (1,738,046) (1,253,409) (2,434,602)
management of liquid
resources and financing
Management of liquid (1,341,478) (1,800,000) (495,064)
resources
Financing 3,227,591 2,757,871 2,642,943
Increase/(decrease) in cash 4 148,067 (295,538) (286,723)
in the period
Reconciliation of operating loss to net cash outflow from
operating activities
Continuing activities
Operating loss (94,561) (291,601) (343,221)
Amortisation of intangible fixed 21,870 15,019 30,147
assets
Depreciation of tangible fixed 86,010 80,585 179,864
assets
Gain on sale of tangible fixed (14,311) - -
assets
Release from deferred grants (25,000) - (30,435)
Increase in stocks (202,821) (239,352) (535,939)
Increase in trade debtors (19,770) (226,150) (352,885)
Decrease/(increase) in 46,561 (83,482) (77,706)
prepayments
(Increase)/decrease in other (165,517) 166,833 235,397
debtors
(Decrease)/increase in trade (67,298) 130,201 104,108
creditors
Increase/(decrease) in other 4,451 (2,691) 8,175
taxes and social security
Increase/(decrease) in accruals 48,174 3,305 (33,958)
Net cash outflow from operating (382,212) (447,333) (816,453)
activities
NOTES
1. Basis of preparation
These unaudited interim financial statements have been
prepared on the basis of the accounting policies set out in
the Group's annual report for the year ended the 31 March
1999.
The financial information contained in these interim
financial statements does not constitute statutory accounts
within the meaning of section 240 of the companies Act 1985.
The financial information for the year ended the 31 March
1999 is an extract from the latest published financial
statements that have been delivered to the registrar of
companies and on which the auditors' report was unqualified.
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 The analysis by geographical area
of the group's turnover, loss
before tax and net assets is set
out below:
(i) turnover
Six months Six months Year ended
ended ended 31 March 1999
30 September 30 September
1999 1998
Sales by Sales Sales by Sales Sales by Sales
destina- by destina- by destina- by
tion origin tion origin tion origin
£ £ £ £ £ £
Geographical
segment
United 284,587 1,380,665 304,239 991,245 997,817 2,289,097
Kingdom
Rest of 1,313,918 238,601 871,176 259,190 1,746,693 490,218
Europe
Rest of 20,761 - 75,020 - 34,805 -
World
1,619,266 1,619,266 1,250,435 1,250,435 2,779,315 2,779,315
(ii) loss before tax
Six months Six months Year ended
ended ended 31 March
30 September 30 September 1999
1999 1998 £
£ £
Geographical segment
United Kingdom (96,996) (295,880) (347,743)
Rest of Europe 2,435 4,279 4,522
Loss before interest (94,561) (291,601) (343,221)
Net interest (15,884) 16,572 22,637
(payable)/receivable
(110,445) (275,029) (320,584)
(iii) net assets
30 30 31 March
September September 1999
1999 1998 £
£ £
Geographical segment
United Kingdom 8,060,933 4,927,438 4,863,194
Rest of Europe 205,615 155,001 165,047
8,266,548 5,082,439 5,028,241
1. Loss per ordinary share
The basic loss per ordinary share is calculated on the loss
of the group of £110,445 for the six months to 30 September
1999 ( six months ended 30 September 1998: £275,029 year
ended 31 March 1999: £320,584) and on the following number
of shares:
a 21,031,041 equity shares being the weighted average
number of shares in issue during the six months ended
the 30 September 1999 after the issue of an additional
3,595,106 new ordinary shares on the 27 August 1999 and
an additional 141,000 new ordinary shares on 10
September 1999
b 19,267,759 equity shares being weighted average number
of shares in issue during the six months ended 30
September 1998
c 19,833,420 equity shares being the weighted average
number of shares in issue during the year ended 31
March 1999
1 .Analysis of net funds
1st April Cash Non-cash 30 September
1999 flow changes 1999
£ £ £ £
Net Cash:
Cash at bank and in 576,779 1,489,545 - 2,066,324
hand
Deposits treated as (495,064) (1,341,478) - (1,836,542)
liquid resources
81,715 148,067 - 229,782
Liquid resources:
Deposits included in 495,064 1,341,478 - 1,836,542
cash
Debt:
Debt due within one (168,912) 121,667 (90,089) (137,334)
year
Debt due after more (355,964) - 90,089 (265,875)
than one year
(524,876) 121,667 - (403,209)
Net Funds 51,903 1,611,212 - 1,663,115
1. Millennium Compliance
The company has completed the upgrading and testing of all
its systems and the Board believes that all reasonable and
appropriate measures have been taken to avoid commercial
disruption.
Copies of this statement will be posted to shareholders and
will be available for a period of 14 days from the Company's
registered office: Phoenix Crescent, Strathclyde Business
Park, Bellshill, Scotland ML4 3NU.