Final Results
For immediate release: FINAL
VALIRX PLC
("ValiRx" or the "Company")
DIRECTORS REPORT AND FINANCIAL STATEMENT
FOR THE PERIOD ENDED 31 DECEMBER 2006
ValiRx Plc (AIM: VAL), the cancer therapeutics company, today announces its
audited results for the year ended 31st December 2006.
CHAIRMAN'S REPORT
For the Period Ended 31 December 2006
In the short term in which the Company traded as ValiRx Plc, advancements were
made in projects and developments with the capacity to deliver significant
shareholder value. These will be covered in greater depth by in the Chief
Executive Officer's report.
Outside of the Company's own activity, ValiRx's position is being further
strengthened as the medical industry moves towards a greater recognition of
epigenomics and associated early screening diagnostic or prognostic approaches.
The interest and support the Company is receiving is very much reflected by the
joining of leading academics to the Company's Scientific Advisory Board - Drs
Tom Brown, David Fell, Nick Lemoine and Robert Weinzel having joined during the
period under review.
I am likewise pleased to welcome post year ended 31st December 2006 Nicholas
Thorniley to the Board as a non-executive director. His extensive career in
corporate broking and his instrumental role in the Company's re-admission to
AIM will be a valuable asset as we look to target further acquisition,
collaborations and investment opportunities going forward.
In short, I am pleased to report the Company continues to make good progress,
delivering on the milestones we set ourselves at the time of the IPO, whilst
maintaining our focus on the development of our product pipeline and
enhancement of our intellectual property. The Board looks forward to another
successful year of achievement in 2007.
Tony Moore, Chairman
25th June 2007
CHIEF EXECUTIVE OFFICER'S REPORT
For the Period Ended 31 December 2006
The Company acquired ValiRx Limited in October 2006. ValiRx Limited is a
biopharmaceutical development company, which was incorporated on 1 June 2006
with the intention of exploiting opportunities in the future healthcare, life
sciences and biopharmaceutical industries. As such there are three closely
inter-related strands to our business:
* A core science focus - where we look to acquire and develop new and
innovative R&D programmes in the epigenomic and diagnostic fields
* A disease and diagnostic focus on oncology - where we look to partner with
organisations in the field to test or develop our products
* A stem cell product and development and diagnostic focus - where we acquire
positions in businesses that are complementary to our disease and science
focus.
I am pleased to report that during the period ended 31st December 2006 and post
period, the business has developed strongly across all its chosen fields of
activity.
Science
In December 2006, our subsidiary, Cronos Therapeutics, announced that it
received the granting of a European patent for its grounding-breaking GeneICE
cancer technology. This was crucial as we have now moved on to the next step of
product development program with Cancer Research Technology UK (`CRT') and the
patent protects our disease-modifying approach to treating cancer, adding
long-term value to our shareholders.
Cronos likewise holds an extensive portfolio of pending and granted patents in
the areas of gene regulation and epigenetic diagnostic technologies. Cronos is
now actively pursuing further collaborations for its two main technologies:
GeneICE and HyperGenomics.
Since the balance sheet date:
* A collaborative agreement was signed with the University of Surrey's
Post-Graduate Medical School to co-develop prostate and bladder cancer
diagnostics based on the Hypergenomics technology.
* Cronos and Physiomics started to work on a programme directed at
development of new GeneICE products.
* Cronos and ATDBio Ltd completed their initial experiments involving
GeneICE. This was significant as it confirmed that the GeneICE drug
currently in development with Cancer Research Technology Limited binds to
its predicted genetic target under model physiological conditions.
* A GeneICE US patent was granted.
Disease Focus
With regards our specific disease focus on oncology, In February 2007, post
period-end, ValiRx announced that it has put in place an agreement with
Physiomics Plc - the European systems biology simulation company - to use its
In Silico simulation of cellular processes to reduce the development time and
costs associated in identifying new therapeutic compounds for the treatment of
cancers. The primary concentration of the initial programme is to investigate
the process of Apoptosis (the natural process of programmed cell death and
turnover) - a process that is frequently disrupted in Cancers.
In addition, through the agreement with the University of Surrey Post-graduate
Medical School, led by Professor Pandha - a leading scientist in the field of
oncology - Cronos' proprietary HyperGenomics technology is now to be used
alongside the data being generated by Professor Pandha's research base to
potentially create a diagnostic platform for the early stage detection of
prostate cancer.
Stem Cell Product & Development
On 4th December 2006, ValiRx announced that it has provided $375,000 in
development funding to its affiliate, Morphogenesis Inc and in addition, that
it had subscribed to 250,000 share warrants. Morphogenesis is currently
developing a portfolio of cell therapy products for the treatment of chronic
disorders. Its most advanced product, ImmumeFX is currently undergoing
pre-clinical trials, potentially providing cancer vaccine solutions that target
tumours in both humans and pets. The US canine market alone is worth in excess
of $200 million a year. So far, the tests have provided promising initial
feedback.
Since 31st December 2007, I have been appointed to the Board. This appointment
forms part of a strategic move by Morphogenesis to migrate key parts of its
early stage technology research to Britain. We believe this move will likewise
prove highlight complementary to the R&D of Cronos.
Strategic Summary
In summary, the progress made indicates the potential of our pipeline of
products. We have put in place a range of strategic agreements and
collaborations in the short period since we have come onto AIM across all our
fields of operation. Furthermore, we remain highly encouraged by the feedback
we have received from the trials completed to date on our technologies.
Financial Overview
The loss after minority interest for the nine months ended 31st December 2006
was £286,957. The loss was in line with expectations. Net cash as 31st December
was £810,639 and turnover from consultancy was less than £10,000.
As planned, research & development costs were £60,000 and other administrative
expenses for the year were £213,000.
The Company is very confident in its prospects for the future and to deliver
shareholder value.
Satu Vainikka
CEO
25th June 2007
FINANCIALS
CONSOLIDATED INCOME STATEMENT
FOR THE PERIOD ENDED 31 DECEMBER 2006
Nine Year
Months
ended ended
31 31 March
December
2006 2006
Notes £ £
Revenue 2 9,577 -
Administrative expenses (273,292) (65,922)
Other operating income - 1,750
─────── ───────
Operating loss 3 (263,715) (64,172)
Loss on deemed disposal of shares in (60,133) -
subsidiary
─────── ───────
Loss on ordinary activities (323,848) (64,172)
before interest
Other interest receivable 7,828 576
and similar income
Interest payable and (49) -
similar charges
─────── ───────
Loss on ordinary activities (316,069) (63,596)
before taxation
Tax on loss on ordinary - -
activities
─────── ───────
Loss on ordinary activities (316,069) (63,596)
after taxation
Minority interest 29,112 -
─────── ───────
Loss for the period (286,957) (63,596)
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Loss per share - basic and 4 (0.11)p (0.09)p
diluted
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The profit and loss account has been prepared on the basis that all
operations are continuing operations.
There are no recognised gains and losses other than those passing through the
profit and loss account.
CONSOLIDATED BALANCE SHEET
AS AT 31 DECEMBER 2006
31 December 2006 31 March 2006
Notes £ £ £ £
ASSETS
Non current assets
Intangible assets 488,027 59,796
Property, plant and 4,833 1,118
equipment
Financial assets: 1,333,770 -
available-for-sale
investments
──────── ────────
1,826,630 60,914
──────── ────────
Current assets
Trade and other receivables 6 154,479 75,220
Cash and cash equivalents 810,639 33,835
──────── ────────
965,118 109,055
LIABILITIES
Current liabilities
Trade and other payables 7 (105,422) (8,772)
──────── ────────
Net current assets 859,696 100,283
──────── ────────
Total assets less current liabilities 2,686,326 161,197
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SHAREHOLDERS' EQUITY
Called up share capital 11,153,055 6,270,555
Share premium 6,979,770 9,881,216
Merger reserve 637,500 -
Reverse acquisition reserve (15,760,591) (15,923,102)
Profit and loss account (354,429) (67,472)
──────── ────────
Total shareholders' equity 2,655,305 161,197
Minority interest 31,021 -
──────── ────────
2,686,326 161,197
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Approved by the Board and authorised for issue on 22 June 2007
S Vainikka G Desler
Director Director
CONSOLIDATED CASH FLOW STATEMENT
FOR THE PERIOD ENDED 31 DECEMBER 2006
Nine Year
Months
ended ended
31 31 March
December
2006 2006
Note £ £ £ £
Cash outflows from operating 1 (53,545) (54,884)
activities
Investing activities
Interest received 7,828 576
Interest paid (49) -
Payments to acquire intangible (7,868) (39,941)
assets
Payments to acquire tangible (5,025) (1,166)
assets
Payments to acquire investments (190,770) -
Purchase of subsidiary 2 1,290,767 -
undertakings, net of cash
acquired
─────── ───────
Net cash generated from/(used 1,094,883 (40,531)
in) investing activities
Financing activities
Issue of ordinary share capital 127,500 125,000
Cost of share issue (392,034) -
─────── ───────
Net cash (used in)/generated (264,534) 125,000
from financing activities
─────── ───────
Net increase in cash and cash 776,804 29,585
equivalents
Cash and cash equivalents at beginning of period 33,835 4,250
─────── ───────
Cash and cash equivalents at end of period 810,639 33,835
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NOTES TO THE CASH FLOW STATEMENT
1 Cash flows from operating activities Nine Year
Months
ended ended
31 31 March
December
2006 2006
£ £
Operating loss (263,715) (64,172)
Depreciation of tangible assets 1,310 48
Amortisation of intangible assets 3,211 2,290
Increase in debtors (176,191) (115)
Increase in creditors within one year 381,840 7,065
─────── ───────
Cash flows from operating activities (53,545) (54,884)
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2 Purchase of subsidiary undertakings Nine Year
Months
ended ended
31 31 March
December
2006 2006
£ £
Cash and cash equivalents in subsidiaries acquired 1,322,937 -
Cash outflow on acquisition (32,170) -
─────── ───────
1,290,767 -
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KEY NOTES TO THE FINANCIAL STATEMENTS
1 Summary of significant accounting policies
1.1 Basis of preparation
Valirx Plc (formerly Azure Holdings Plc) is a company incorporated in the
United Kingdom under the Companies Act 1985.
The group financial statements consolidate those of the company and its
subsidiaries ('the group').
The group financial statements have been prepared and approved by the
Directors in accordance with International Financial Reporting Standards
('IFRS') and International Financial Reporting Interpretations Committee
('IFRIC') interpretations that have been adopted for use in the European
Union, the Companies Act 1985 and Article 4 of the IAS Regulation.
The group financial statements have been prepared under the historical cost
convention or fair value where appropriate.
1.2 First-time adoption of International Financial Reporting Standards ('IFRS')
In preparing these consolidated financial statements, the group has elected
to apply certain exemptions available under IFRS 1 'First-time Adoption of
International Reporting Standards'. These are set out in note 21.
In accordance with IFRS 1, the group has taken the exemption not to restate
the comparatives for IAS 32 'Financial Instruments: Disclosure and
Presentation' and IAS 39 'Financial Instruments: Recognition and
Measurement.' Comparative information in respect of these items is presented
on a UK GAAP basis as previously reported.
1.3 Basis of consolidation
The group financial statements consolidate the financial statements of the
company and all its subsidiaries. Subsidiaries include all entities over
which the group has the power to govern financial and operating policies.
The existence and effect of potential voting rights that are currently
exercisable or convertible are considered when assessing whether the group
controls another entity. Subsidiaries are consolidated from the date on
which control commences until the date that control ceases. Intra-group
balances and any unrealised gains and losses on income or expenses arising
from intra-group transactions, are eliminated in preparing the consolidated
financial statements.
On 3 October 2006, Valirx Bioinnovations Limited ('Bioinnovations') acquired
60.28% of the issued share capital of Cronos Therapeutics Limited ('Cronos')
in exchange for shares in Bioinnovations. Concurrently, the Company, then
called Azure Holdings plc ("Azure"), acquired the entire issued share
capital of Bioinnovations in a share for share transaction. As a result of
these transactions, the former shareholders of Cronos became the majority
shareholders in Azure. Accordingly, the substance of the transaction was
that Cronos acquired Azure in a reverse acquisition. As part of the business
combination, Azure changed its name to Valirx Plc ("Valirx").
Under IFRS 3 'Business Combinations', the acquisition of Cronos has been
accounted for as a reverse acquisition. As a consequence of applying reverse
acquisition accounting, the results for the period ended 31 December 2006
comprise those of Cronos plus those of Valirx and Bioinnovations from 3
October 2006. The comparative figures are those of Cronos for the year ended
31 March 2006. The consolidated balance sheet comprises the combined
balances of Cronos, Valirx and Bioinnovations at 31 December 2006. The
comparative consolidated balance sheet is that of Cronos at 31 March 2006.
1.4 Sources of estimation uncertainty
The preparation of the financial statements in conformity with generally
accepted accounting principles requires the use of estimates and assumptions
that affect the reported amounts of assets and liabilities at the date of
the financial statements and the reported amounts of revenue and expenses
during the reporting period. Although these estimates are based on
management's best knowledge of the amounts, events or actions, actual
results ultimately may differ from these estimates.
The group believes that the most significant critical judgement area in the
application of its accounting policies is the carrying value of the
financial assets - available-for-sale investments and goodwill.
1.5 Goodwill
Goodwill on acquisition of subsidiaries represents the excess of the cost of
acquisition over the fair value of the group's share of the net identifiable
net assets and contingent liabilities acquired. Identifiable assets are
those which can be sold separately or which arise from legal rights
regardless of whether those rights are separable. Goodwill on acquisition of
subsidiaries is included in intangible assets. Goodwill is not amortised but
tested annually for impairment or when trigger events occur, and is carried
at cost less accumulated impairment losses.
1.6 Other intangible assets
Acquired licences, trademarks and patents are capitalised at cost and are
amortised on a straight-line basis over their useful life. Patents are
amortised over 16 years.
1.7 Property, plant and equipment
Property, plant and equipment are stated at cost less depreciation.
Depreciation is provided at the following rates per annum to write off
the cost of property, plant and equipment, less estimated residual value,
on a straight line basis from the date on which they are brought into
use:
Computer equipment 33% per annum straight line
1.8 Impairment of assets
The carrying value of property, plant and equipment and intangibles is
reviewed for impairment when events or changes in circumstances indicate
the carrying value may be impaired. An impairment loss is recognised in
the income statement for the amount by which the asset's carrying amount
exceeds its recoverable amount. The recoverable amount is the higher of
an asset's fair value less costs to sell and value in use.
1.9 Investments
The group classifies its investments as available-for-sale financial
assets in accordance with IAS 39.
Available-for-sale financial investments are non-derivative assets. They
are included in non-current assets unless management intends to dispose
of the investment within 12 months of the balance sheet date. After
initial recognition available-for-sale assets are measured at fair value
with gains or losses being recognised as a separate component of equity
until the investment is de-recognised or until the investment is
determined to be impaired at which time the cumulative gain or loss
previously reported in equity is included in the income statement. If a
fair value for an investment cannot be reliably measured that investment
will be carried at cost.
An impairment test is performed annually on the carrying value of each
investment. If an available-for-sale asset is impaired, an amount
comprising the difference between its carrying value and its cost and its
fair value is transferred from equity to the income statement.
1.10 Trade and other receivables
Trade and other receivables are recognised and carried at the lower of
their original amount less an allowance for any doubtful amounts. An
allowance is made when collection of the full amount is no longer
considered possible.
1.11 Equity-settled share-based payment
The group makes equity-settled share-based payments to its employees and
directors. The fair value of options granted is recognised as an
employee expense with a corresponding increase in equity. The fair value
is measured at grant date and spread over the period during which the
employees become unconditionally entitled to the options. The fair value
of the options granted is measured based on the Black-Scholes framework,
taking into account the terms and conditions upon which the instruments
were granted. At each balance sheet date, the company revises its
estimate of the number of options that are expected to become
exercisable.
The group has taken advantage of the transitional provisions of IFRS2
'Share Based Payments' in respect of equity-settled share-based payments
and has applied IFRS2 only to equity-settled awards granted after 7
November 2002 that had not vested on 31 March 2005.
1.12 Taxation
Taxation expense represents the sum of current tax and deferred tax.
The tax currently payable is based on the taxable loss for the period using the
tax rates that have been enacted or substantially enacted by the balance sheet
date. Taxable loss differs from the net loss as reported in the income
statement because it excludes items of income or expense that are taxable or
deductible in other years and it further excludes items that are never taxable
or deductible.
Deferred tax assets are only recognised to the extent that it is probable that
future taxable profit will be available against which the asset can be
utilised.
Deferred tax is charged or credited in the income statement, except when it
relates to items charged or credited to equity, in which case the deferred tax
is also dealt with in equity.
1.13 Turnover
Revenue represents sales and services to third party customers in the
health sector, stated net of any applicable value added tax. Revenue is
recognised when the services are provided.
1.14 New standards and interpretations
During the period the International Accounting Standards Board ('IASB')
and International Financial Reporting Interpretations Committee ('IFRIC')
issued the following standards and interpretations which are effective
for annual accounting periods beginning on or after the stated effective
date. These standards and interpretations are not effective for and have
not been applied in the preparation of this financial information.
Effective date
International Accounting Standards (IFRS/IAS)
IFRS 7 Financial instruments: Disclosures 1 January 2007
IFRS 8 Operating Segments 1 January 2009
IAS 1 Amendment - Presentation of Financial 1 January 2007
Statements: Capital Disclosures
IFRIC interpretations
IFRIC 7 Applying the Restatement Approach under IAS 1 March 2006
29 -
Financing Reporting in Hyperinflationary Economies -
IFRIC 8 Scope of IFRS 2 1 May 2006
IFRIC 9 Reassessment of Embedded Derivatives 1 June 2006
IFRIC 10 Interim Financial Reporting and Impairment 1 November 2006
IFRIC 11 Group and Treasury Share Transactions 1 March 2007
IFRIC 12 Service Concessions Arrangements 1 January 2008
The group does not anticipate that the adoption of these standards and
interpretations will have a material impact on the group's financial
statements on adoption.
2 Revenue
The total revenue of the group for the period has been derived from its
principal activity wholly undertaken in the United Kingdom.
3 Operating loss Nine Year
Months
ended ended
31 31 March
December
2006 2006
£ £
Operating loss is stated after charging:
Amortisation of intangible assets 3,211 2,290
Depreciation of tangible assets 1,310 48
Auditors' remuneration - parent company 10,000 -
Auditors' remuneration - subsidiary undertakings 10,000 5,000
Auditors' remuneration - previous firm 5,525 -
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4 Earnings per ordinary share
The earnings and number of shares used in the calculation of earnings per
ordinary share are set out below:
Nine Months Year
ended ended
31 December 31 March
2006 2006
Basic:
Loss for the financial period 286,957 63,596
Weighted average number of shares 264,684,539 67,500,414
Loss per share 0.11p 0.09p
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There was no dilutive effect from the share options outstanding during the
year (note 14).
5 Acquisitions
On 3 October 2006, Valirx Bioinnovations Limited ('Bioinnovations') acquired
60.28% of the issued share capital of Cronos Therapeutics Limited ('Cronos')
by means of a share-for-share exchange. Concurrently, Valirx acquired the
entire share capital of Bioinnovations by means of a share-for-share
exchange. As a result of these transactions, the former shareholders of
Cronos became the majority shareholders of Valirx.
In accordance with IFRS 3 'Business Combinations', these transactions have
been accounted for as a reverse acquisition. The key features of this basis
of consolidation are:
- The consolidated IFRS financial statement is a continuation of the
financial statement of Cronos and the retained earnings recognised are a
continuation of those of Cronos immediately before the business combination.
- The consolidated income statement for the nine months ended 31 December
2006 includes the results of Cronos for the nine months ended 31 December
2006 and of Valirx and Bioinnovations from 3 October 2006, the date of the
reverse acquisition.
- The assets and liabilities of Cronos are measured based on their
pre-combination carrying amounts.
- The equity structure appearing in the consolidated financial statement
reflects the equity structure of the legal parent, Valirx.
- Valirx and Bioinnovations have been consolidated from the date of the
reverse acquisition using the fair value of their assets and liabilities at
that date, with the exception of the financial assets in Bioinnovations
where the investment is stated at historical cost (note 10). The recognised
value of assets purchased were as follows. There was no difference between
the recognised value and the fair value of the assets acquired.
Valirx
Bioinnovations
Valirx Plc Limited
£ £
Financial assets - 1,143,000
Receivables 20,387 26
Cash and cash equivalents 1,322,937 -
Payables (248,032) -
─────── ───────
Net assets acquired 1,095,292 1,143,026
Goodwill 394,613 28,961
─────── ───────
Consideration satisfied by shares 1,489,905 1,171,987
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The company has entered into a Call Option Agreement ('the Agreement') with
the minority shareholders of Cronos. Under the terms of the Agreement, the
company has the right to acquire the remaining 39.72% of the ordinary shares
in Cronos. The agreement runs for a period of two years from the date of
re-admission to the AIM market. The consideration payable will either be the
issue of 195,000,000 new ordinary shares in the company or the payment of £
2.6 million.
6 Trade and other receivables 31 31 March
December
2006 2006
£ £
Trade receivables 9,458 -
Called up share capital not paid - 75,000
Other receivables 136,065 220
Prepayments and accrued income 8,956 -
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154,479 75,220
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7 Trade and other payables 31 31 March
December
2006 2006
£ £
Trade payables 39,712 -
Other payables - 250
Accruals and deferred income 65,710 8,522
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105,422 8,772
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8 Related party transactions
During the period, Cronos paid consultancy fees to Cronos Ventures Limited
amounting to £16,835 (year ended 31 March 2006 - £28,000), a company in
which both J Micallef and S Vainikka are directors and shareholders.
During the period, Cronos carried out business with Imperial College
Innovations Limited on normal commercial terms amounting to £nil (Year
ended 31 March 2006 - £46,773). Imperial College Innovations Limited is a
shareholder of Valirx.
9 Post balance sheet events
Since the balance sheet date:
1 A collaborative agreement was signed with the University of Surrey's
Post-graduate Medical School to co-develop prostate and bladder cancer
diagnostics based on the Hypergenomics technology.
2 Cronos and Physiomics started to work on a programme directed at
development of new GeneICE products.
3 Cronos and ATDBio Ltd completed their initial experiments involving
GeneICE. This was significant as it confirmed that the GeneICE drug
currently in development with Cancer Research Technology Limited binds to
its predicted genetic target under model physiological conditions.
4 A GeneICE US patent was granted.
Copies of the accounts have been despatched to shareholders. Additional copies
are available from the company's registered office at 24 Greenville Street,
London, EC1N 8SS and their website www.valirx.com
For Further Information, please contact:
ValiRx Plc WH Ireland GTH Communications
Dr Satu Vainikka David Youngman Toby Hall / Jade Mamarbachi
+44 (0) 203 008 4416 +44 (0) 161 832 2174 +44 (0) 20 7153 8035