Interim Results
Futura Medical PLC
05 September 2005
Press Release 5 September 2005
Futura Medical plc
Interim Results for the six months ended 30 June 2005
Futura Medical plc ('Futura' or 'the Company'), the AIM-quoted pharmaceutical
and medical device group that develops innovative products for the sexual
healthcare market, announces its interim results for the six months ended 30
June 2005.
Highlights
- Excellent progress with three lead development products:
• CSD500: submission of dossier for EU marketing authorisation on track
for November 2005
• FLD500: global distribution rights licensed to SSL International and
all clinical work successfully completed
• MED2002: exclusive co-development programme with major pharmaceutical
group on schedule, with pilot results expected in November
- Loss of £856,027 (First half 2004: £578,702) reflecting increased R&D
spend of £686,116 (First half 2004: £360,391) in line with expected
acceleration of development programmes
- Other administration costs of £380,378 broadly in line with comparative
period in 2004, demonstrating tight cost management
- £2.7million cash in bank as at 30 June 2005
- Chairman Dr Bill Potter to commit more time to the Company as lead
products move closer to market
Commenting on the results, James Barder, Chief Executive, said:
'The past six months have been the most productive and busiest in the history of
Futura and we fully expect the momentum to increase over the next six months.
The submission of the EU dossier for marketing authorisation of CSD500 and the
completion of further MED2002 pilot work to conclude global distribution
arrangements for the first OTC pharmaceutical treatment for Erectile Dysfunction
are just two of the key milestones we expect to achieve over the coming months.
'We are also delighted that our Chairman, Dr Bill Potter, will be committing
more time to Futura having become increasingly involved in the product
development programmes this year. '
For further information:
Futura Medical plc
James Barder, Chief Executive Tel: +44 (0) 1483 685 670
mail to: james.barder@futuramedical.co.uk www.futuramedical.co.uk
Media enquiries:
Abchurch
Peter Curtain / Samantha Robbins Tel: +44 (0) 20 7398 7700
mailto: samantha.robbins@abchurch-group.com www.abchurch-group.com
CHAIRMAN & CHIEF EXECUTIVE INTERIM STATEMENT
The past six months have been the most productive and busiest in the history of
Futura and we fully expect the momentum to continue increasing over the next six
months. The submission of the EU dossier for marketing authorisation for CSD500
and completion of further MED2002 pilot work to conclude global commercial
distribution arrangements for the first over-the-counter ('OTC') pharmaceutical
treatment for Erectile Dysfunction are two of the key milestones we expect to
achieve over the coming months.
CSD500 - ZanifilTM
Condom safety device
In April we announced that following satisfactory pilot stability results, SSL
International plc ('SSL') was commencing initial manufacturing trials. Since
April, a series of manufacturing trials have been successfully completed.
Stability studies in compliance with the relevant regulatory requirements are in
progress and if the results continue to be satisfactory, the submission for EU
marketing authorisation will be made in November 2005.
We have been advised that dossier review by EU regulators and subsequent
approval is likely to take six months from submission. During this period we
will be working closely with SSL as preparations commence for the marketing
research being conducted by SSL and subsequent launch of CSD500.
FLD500
Female lubrication device
We have made significant progress with the development of FLD500. In July, we
announced that SSL had exercised its option for global distribution rights.
Recently, we also announced that following a review of all the clinical data and
supported by preliminary feedback from an EU Competent Authority, we were not
seeking to conduct further clinical studies thereby saving both time and money
in the development programme.
CSD500 is a gel localised within the teat of a condom whilst FLD500 is a thin
elastomer film coating the exterior of a condom. Although there is considerable
overlap in the technical aspects of the development programme with CSD500, the
elastomer film does present some different technical manufacturing challenges.
These technical challenges are currently being evaluated and we hope to make an
announcement shortly relating to the expected timetable for the completion of
the EU dossier for marketing authorisation.
MED2002 - EroxonTM
Treatment for Erectile Dysfunction ('ED')
In our most recent year-end statement we announced that we had entered into
confidential and exclusive discussions with a major global pharmaceutical group
('MGPG') on a proposed agreement for the worldwide development and marketing of
MED2002.
The commitment of both parties to an exclusivity period has enabled Futura and
MGPG to allocate resources to the joint development of MED2002. In our view,
the commercial benefits such a major development and distribution partner could
bring to MED2002 increases the potential for the product to become the first OTC
pharmaceutical treatment for Erectile Dysfunction.
Since March, considerable work has been conducted by MGPG to confirm the optimum
regulatory strategy for MED2002 in the key consumer markets and evaluate the
market opportunity for MED2002. This work, as agreed under the planned schedule
of joint development between Futura and MGPG, will complete this autumn.
As we reported during July 2004, in vitro tests of our revised formulation,
MED2002, showed dramatically improved dermal absorption rates. In recent in
vivo trials in healthy men absorption rates were even higher than predicted from
the in vitro data, demonstrating the significant improvements that have been
made to the formulation. These initial results support the potential for this
product to offer an effective, rapid-onset, locally active dose with a low
systemic uptake which will help to reduce unwanted side effects.
Further in vivo trials, financed by Futura, are ongoing with the objective of
determining the optimum dose and formulation to maximise local effects in the
penis whilst minimising systemic uptake throughout the body. It is intended
that this will reduce the potential for adverse interaction with other centrally
acting drugs that may also be taken concomitantly by the patient, especially
PDE5 inhibitors such as Viagra(R), Cialis(R) or Levitra(R). Greater dermal
absorption rates will also deliver the active ingredient more rapidly to the
penis, which should be reflected in an improved time to onset of an erection.
We remain optimistic of the positive outcome of these trials and expect to be
able to report to our shareholders on the results of the studies in November and
conclude our negotiations with MGPG thereafter as planned.
Business analysis
Our overall loss for the six months ended 30 June 2005 was £856,027. Research
and development costs of £686,116 are 90% higher compared with last year's
interim results. This reflects the increased activity as we seek to
aggressively push through our development programme. Other administrative costs
of £380,378 are broadly in line with the comparative six month period, rising
only 4%, as overheads stabilise having absorbed the charges associated with
becoming an AiM quoted company. We continue to maintain a tight control on
expenditure. Cash at the end of June 2005 was £2.7 million.
An eye on the future
The revised carrier formulation for MED2002 has delivered significantly improved
absorption profiles with rates of up to 1,000% greater than those of previous
versions of MED2002. Moreover, this new topical delivery platform has enabled
us to apply for further intellectual property rights. In recent months we have
commissioned an investigation into other topically applied medications that
could benefit from such a vastly improved absorption profile. Critical to this
analysis was identifying existing topical medications where a significant
increase in efficacy would have consequences greater than just a reduction in
dosage.
We have identified two products that fit these criteria. This development is a
by-product of the MED2002 programme and we have been careful to ensure this has
had limited cost and resource consequences for Futura. Moreover, as we shall be
seeking to improve existing pharmaceutical products rather than develop new
ones, the regulatory challenges are considerably reduced. We expect to report
further on this over the next few months.
We continue to evaluate other external opportunities. Nevertheless our priority
remains the completion of the development of our three lead products and our
resources and energies are focused on this.
Once more this leads us to thank all the Futura team for their continuing
commitment and work which continues to build value for our shareholders.
Dr W D Potter, Chairman J H Barder, Chief Executive
Board changes
Over the past few months Dr Bill Potter has become increasingly involved in the
product development programme of Futura. We expect that this role will continue
to increase as the exciting developments at Futura gain momentum and with this
in mind Bill has agreed to commit more time to us. The rest of the Board are
delighted that Futura will be able to further leverage the undisputed talents
and expertise of Bill. However, in light of Bill adopting a more executive
role, the Board has decided that Bill should step down from the Audit Committee
and he has agreed to this. The Board has appointed Andrew Slater to the Audit
Committee in his place.
J H Barder, Chief Executive
CONSOLIDATED PROFIT AND LOSS ACCOUNT
Notes Unaudited Unaudited Audited
6 months 6 months year
ended ended ended
30 June 30 June 31 December
2005 2004 2004
£ £ £
Turnover - 4,646 129,863
Research and development costs (686,116) (360,391) (960,141)
Other administrative costs (380,378) (364,297) (745,806)
Administrative expenses (1,066,494) (724,688) (1,705,947)
Operating loss (1,066,494) (720,042) (1,576,084)
Other interest receivable and 77,937 76,159 177,047
similar income
Loss on ordinary activities before (988,557) (643,883) (1,399,037)
taxation
Tax on loss on ordinary activities 2 132,530 65,181 170,086
Loss on ordinary activities after 3 (856,027) (578,702) (1,228,951)
taxation and retained loss for the
period
Basic and diluted loss per share 4 (1.8) (1.2) (2.6)
(pence)
All amounts relate to continuing activities.
Statement of Total Recognised Gains and Losses
There were no recognised gains and losses in the period, or in the prior
periods, other than those passing through the profit and loss account above and
therefore no separate statement of total recognised gains and losses has been
presented.
CONSOLIDATED BALANCE SHEET
Notes Unaudited Unaudited Audited
30 June 30 June 31 December
2005 2004 2004
£ £ £
Fixed Assets
Tangible assets 27,914 24,567 28,120
_________ _________ _________
27,914 24,567 28,120
_________ _________ _________
Current Assets
Stock 5,320 16,045 14,812
Debtors 398,445 260,187 258,211
Cash at bank and in hand 2,661,562 4,299,913 3,672,647
_________ _________ _________
3,065,327 4,576,145 3,945,670
Creditors: amounts falling due within (200,753) (242,498) (225,275)
one year
_________ _________ _________
Net current assets 2,864,574 4,333,647 3,720,395
_________ _________ _________
Total net assets 2,892,488 4,358,214 3,748,515
_________ _________ _________
Capital and reserves
Called up share capital 97,357 97,167 97,357
Share premium account 5 8,425,707 8,385,347 8,425,707
Other reserves 1,152,165 1,152,165 1,152,165
Profit and loss account (6,782,741) (5,276,465) (5,926,714)
_________ _________ _________
Equity shareholders' funds 6 2,892,488 4,358,214 3,748,515
_________ _________ _________
CONSOLIDATED CASH FLOW STATEMENT
Notes Unaudited Unaudited Audited
6 months 6 months year
ended ended ended
30 June 30 June 31 December
2005 2004 2004
£ £ £
Net cash outflow from operating 7 (1,064,305) (691,259) (1,559,590)
activities
_________ _________ _________
Returns on investments and servicing
of finance
Interest received 64,154 69,056 175,141
_________ _________ _________
Net cash inflow from returns on 64,154 69,056 175,141
investments and servicing of
finance
_________ _________ _________
Corporation Tax
Research and development tax credit - - 108,436
received
_________ _________ _________
- - 108,436
_________ _________ _________
Capital expenditure
Payments to acquire tangible assets (10,934) (10,357) (21,648)
Proceeds on disposal of fixed - - 170
assets
_________ _________ _________
Net cash outflow from capital (10,934) (10,357) (21,478)
expenditure
_________ _________ _________
Net cash outflow before use of (1,011,085) (632,560) (1,297,491)
liquid
resources and financing
_________ _________ _________
Management of liquid resources
Decrease/(Increase) in short term 8 986,301 (1,888,089) (1,160,993)
deposits
_________ _________ _________
Financing
Issue of ordinary shares - 2,604,000 2,644,550
Expenses paid in connection with - (76,120) (76,120)
share issues
_________ _________ _________
Net cash inflow from financing - 2,527,880 2,568,430
_________ _________ _________
(Decrease)/Increase in net cash 8 (24,784) 7,231 109,946
_________ _________ _________
1. Basis of preparation
The unaudited Interim Report was approved by the Board of Directors on 2
September 2005.
The financial information contained in this Interim Report has been prepared on
the basis of the accounting policies set out in the Group's Annual Report for
the year ended 31 December 2004.
The financial information for the six months ended 30 June 2005 and for the six
months ended 30 June 2004 is unaudited.
The financial information for the Group set out above does not constitute '
statutory accounts' within the meaning of Section 240 of the Companies Act 1985.
The information for the year ended 31 December 2004 has been extracted from
the statutory accounts of Futura Medical plc for that period which received an
unqualified audit report and have been delivered to the Registrar of Companies.
2. Taxation
Taxation represents tax credits for certain research and development expenditure
based on the expenditure incurred in the relevant period or year. Deferred tax
assets have not been recognised on the basis that their future economic benefit
is not certain.
3. Dividends
No dividends have been paid and none are proposed.
4. Loss per ordinary share
The loss attributable to ordinary shareholders and weighted average number of
ordinary shares for the purpose of calculating the diluted earnings per ordinary
share are identical to those used for basic earnings per share. This is because
the exercise of share options would have the effect of reducing the loss per
ordinary share and is therefore not dilutive under the terms of Financial
Reporting Standard 14.
The calculation of the loss per ordinary share is based on a loss of £856,027
(six months to 30 June 2004: loss of £578,702; year to 31 December 2004: loss of
£1,228,951) and on a weighted average of 48,678,601 shares in issue (six months
to 30 June 2004: 47,471,613 shares; year to 31 December 2004: 48,069,839
shares).
5. Share premium
Unaudited Unaudited Audited
6 months 6 months year
ended ended ended
30 June 30 June 31 December
2005 2004 2004
£ £ £
Opening share premium 8,425,707 5,864,117 5,864,117
Premium on shares issued - 2,597,350 2,637,710
Less: share issues costs - (76,120) (76,120)
_________ _________ _________
Closing share premium 8,425,707 8,385,347 8,425,707
_________ _________ _________
6. Reconciliation of movements in shareholders' funds
Unaudited Unaudited Audited
6 months 6 months year
ended ended ended
30 June 30 June 31 December
2005 2004 2004
£ £ £
Retained loss for the period (856,027) (578,702) (1,228,951)
Net proceeds from issue of shares - 2,527,880 2,568,430
_________ _________ _________
Net (decrease)/increase in (856,027) 1,949,178 1,339,479
shareholders' funds
Opening shareholders' funds 3,748,515 2,409,036 2,409,036
_________ _________ _________
Closing shareholders' funds 2,892,488 4,358,214 3,748,515
_________ _________ _________
7. Reconciliation of operating profit to operating cash flows
Unaudited Unaudited Audited
6 months 6 months year
ended ended ended
30 June 30 June 31 December
2005 2004 2004
£ £ £
Operating loss (1,066,494) (720,042) (1,576,084)
Depreciation 7,758 7,690 15,414
Loss on sale of fixed assets - - 3,897
Decrease in stocks 9,492 1,234 2,467
Decrease/(increase) in debtors 6,079 (39,711) (46,463)
(Decrease)/increase in creditors (21,140) 59,570 41,179
_________ _________ _________
Net cash outflow from operating (1,064,305) (691,259) (1,559,590)
activities
_________ _________ _________
8. Reconciliation of net cash flow to movement in net funds
Unaudited Unaudited Audited
6 months 6 months year
ended ended ended
30 June 30 June 31 December
2005 2004 2004
£ £ £
(Decrease)/increase in cash in the (24,784) 7,231 109,946
period
Cash (outflow)/inflow from changes (986,301) 1,888,089 1,160,993
in liquid resources
_________ _________ _________
Movement in net funds in the (1,011,085) 1,895,320 1,270,939
period
Net funds at start of period 3,672,647 2,401,708 2,401,708
_________ _________ _________
Net funds at end of period 2,661,562 4,297,028 3,672,647
_________ _________ _________
This information is provided by RNS
The company news service from the London Stock Exchange
Latest directors dealings
- 2 days ago Mattioli Woods
- 2 days ago Morgan Advanced Materials
- 2 days ago Capita
- 2 days ago Judges Scientific
- 2 days ago Me Group International