ValiRx Plc
("ValiRx" or "the Company")
PRELIMINARY RESULTS
For the twelve months ended 31 December 2009
ValiRx Plc (AIM: VAL), a life science company with a focus on cancer diagnostics and therapeutics for personalised medicine, today announces its preliminary results for the twelve month period ended 31 December 2009.
HIGHLIGHTS
Successful completion of next phase of preclinical work on GeneICE lead drug candidate supported by a Eurostar Grant, bringing GeneICE candidate closer to 'first-in-human' trial; further development milestones anticipated to be reached during this first of two years of the Eurostar programme;
Launch of ValiMedix, the sales and distribution arm of ValiRx and the steady growth in sales of its range of SELFCheck testing kits in Europe as of Q4 2009; additionally the Company has extended the commercialisation of these products to North America;
Working capital requirement secured through recently completed fundraising and confirmation of grants;
Additional patents have been filed and granted, strengthening the Company's IP portfolio;
Partnering and funding agreement for epigenetic analysis. This provides additional funding for prototype development in respect of epigenetic analysis and mapping, involving the understanding and measurement of changes in gene activity; and
Focused corporate development with the purpose of creating next generation of diagnostic technologies validated to deliver reproducible results and first or best in class epigenetic anti-cancer drugs.
Dr Satu Vainikka, CEO of ValiRx, commented:
"We are making steady advancements in the commercialisation of our diagnostic technologies for the early detection of cancer and the development of our GeneICE platform at a time when the healthcare sector is increasingly striving to move towards personalised testing and medicine to improve patient outcome. The Directors of ValiRx believe that the Company is building technology and drug platforms with potential to challenge leading players in the cancer market."
Annual Report and Accounts
The Annual Report and Accounts have been dispatched to shareholders today.
Annual General Meeting
Notice is hereby given that the Annual General Meeting (Meeting) the Company will be held at the offices of Rooks Rider Solicitors, Challoner House, 19 Clerkenwell Close, London EC1R 0RR on Wednesday 30 June 2010 at 10.00 am.
For more information, please contact:
ValiRx plc |
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Dr. Satu Vainikka |
Tel: +44 (0) 20 3008 4416 |
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WH Ireland Limited - Nominated Adviser |
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Katy Mitchell |
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Hybridan LLP - Broker |
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Claire Noyce |
Tel: +44 (0) 207 947 4350 |
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Peckwater PR
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Tarquin Edwards |
Tel: +44 (0)7879 458 364 |
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Notes for Editors
ValiRx Plc
ValiRx plc is a biopharmaceutical company developing novel technologies and products in oncology therapeutics and diagnostics. It is headquartered in London and admitted to AIM in October 2006. The Group has a portfolio of innovative epigenetic technologies and products with worldwide exclusive rights and patents. Its technologies can also be applied to other fields of medicine, including those such as neurology and inflammatory diseases.
*ValiPharma is the therapeutics division with two embedded technologies primarily directed at the treatment of cancers. Of particular note is GeneICE, ValiRx's technology for controlling rebellious genes, which was awarded a Eurostars grant to the value of €1.2 million to fund the development of the GeneICE products through preclinical stages in cancer treatments
**ValiMedix Ltd is a UK based company dedicated to building itself into profitable Point of Care diagnostics companies. Initially this will be achieved through a programme of acquisitions accompanied by the in-licensing of products and product ranges which may be generic or with associated intellectual property that can be commercialised through existing established distribution channels to end users.
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VALIRX PLC |
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CHAIRMAN'S REPORT |
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FOR THE YEAR ENDED 31 DECEMBER 2009 |
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I have pleasure presenting the Company's results for the twelve months ended 31 December 2009. |
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As I reported in the my statement made twelve months ago, the sale of our 10% stake in ValiBio S.A. ("ValiBio"), our wholly owned Belgian subsidiary, to Biofield Corp ("Biofield's) had encountered a number of difficulties. Unfortunately the deal has now fallen away, as a result of Biofield's inability to raise sufficient funds to complete its side of the transaction. This matter has now been referred to our lawyers, and the Company will provide further updates in due course. |
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On a slightly happier note, last year I also reported that we had reached agreement in principle for a grant in the form of a loan of €1.05 million from one the Belgian Regions to ValiBio. As announced on 22 December 2009, I can confirm that this loan has now been approved and drawdown should begin in the second half of the current year. Although somewhat later than originally anticipated this is a welcome event that should enable ValiBio to accelerate its product development on the diagnostic side. |
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In my last year's report I also commented on our difficulties in generating revenues for the first time from our range of diagnostics and drug products. I am therefore pleased to report that we formed a new wholly owned subsidiary, ValiMedix Limited, in August last year and sales from this division are starting to build up satisfactorily (revenue for this division was £8,000 for the period under review). |
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The therapeutics subsidiary, Valipharma Limited, had another successful year, completing additional preclinical work on GeneIce following the winning of the €1.2 million Eurostar grant. Over the last eighteen months all development milestones have been met and on current plans this lead compound could enter Phase 1 trials sometime during the first part of 2011. |
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Your company successfully completed a £0.5 million funding round earlier this year and this once again highlights the continuing support of shareholders. |
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Outside the Company's own activities, the Directors' believe ValiRx's position continues to strengthen as the industry moves towards a greater recognition of epigenomics and early screening diagnostics. |
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On a personal note, I would like to thank both the executive team and non-executive directors for the significant contribution both groups have made to the business over the last twelve months. |
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N Thorniley |
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Chairman |
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3 June 2010 |
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VALIRX PLC |
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CHIEF EXECUTIVE OFFICER'S REPORT |
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FOR THE YEAR ENDED 31 DECEMBER 2009 |
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Over the period under review, I am pleased to report on the continued solid progress of your Company and on the attainment of a number of important milestones. |
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My report highlights major operational activities, whilst the Chairman's report will cover the more strategic activities. |
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In the first instance, ValiRx completed a successful funding (£0.98 million) through an equity placing to secure the development of the business. Post period end, the Company was delighted to receive further support (£0.5 million) from its shareholders by way of a recent placing in April this year.
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During the reporting period, we have continued preclinical work with GeneICE following our award of a Eurostar grant to develop the Company's lead compound and I am pleased to also report that development milestones were met. GeneICE compounds have the potential to freeze the development and growth of cancerous cells and also have potential major applications in inflammatory disease and inherited genetic conditions. ValiRx's is currently leading a consortium of three companies, and retains commercial rights for GeneICE from the programme. |
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With respect to associated diagnostic activities, we were also delighted to receive partnership and funding agreement for epigenetic analysis. We have made further progress with the development of our diagnostic tests during the period and subsequently. Significant progress has been made in expanding to other indications and we are also continuing to develop our intellectual portfolio, providing the company with potential further value creation. |
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The market launch of our new diagnostic product trading platform, ValiMedix has been successful as can be seen by the steady roll-out and expansion of its range of self-testing kits which are being marketed internationally by the Group under the Selfcheck brand and with revenues being generated from Q4 2009. As an increasing number of personalised approaches to therapeutics and diagnostics are required in the marketplace we are confident that, with our expertise and trading platform, we are well positioned within the marketplace and the Company will continue its development into a commercial life sciences business. |
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Looking to the future, we continue to look for further commercial opportunities and partnering contracts whilst at the same time moving forward with the therapeutic development programmes. Our aim continues to lie in the delivery of earlier and more accurate diagnostics and more targeted and effective therapies across the oncology sector. |
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Satu Vainikka |
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Chief Executive Officer |
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3 June 2010 |
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VALIRX PLC |
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CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME |
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FOR THE YEAR ENDED 31 DECEMBER 2009 |
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2009 |
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2008 |
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£ |
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£ |
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Revenue |
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29,326 |
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30,748 |
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Cost of sales |
(2,968) |
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- |
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─────── |
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─────── |
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Gross profit |
26,358 |
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30,748 |
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Administrative expenses |
(1,389,010) |
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(1,258,063) |
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Other operating income |
- |
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1,400 |
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───────── |
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───────── |
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Operating loss |
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(1,362,652) |
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(1,225,915) |
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Amounts written off investments |
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(240,737) |
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(664,239) |
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───────── |
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Loss on ordinary activities before interest |
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(1,603,389) |
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(1,890,154) |
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Finance income |
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55 |
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5,092 |
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Finance costs |
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(3,180) |
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(2,725) |
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───────── |
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Loss on ordinary activities before taxation |
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(1,606,514) |
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(1,887,787) |
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Income tax expense |
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163,423 |
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- |
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───────── |
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Loss on ordinary activities after taxation |
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(1,443,091) |
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(1,887,787) |
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Minority interest |
- |
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31,890 |
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───────── |
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Loss for the year |
(1,443,091) |
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(1,855,897) |
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Loss per share - basic and diluted |
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(1.14)p |
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(4.13)p |
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═══════ |
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There are no recognised gains and losses other than those passing through the statement of comprehensive income. |
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VALIRX PLC |
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STATEMENT OF CHANGES IN SHAREHOLDERS EQUITY |
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FOR THE YEAR ENDED 31 DECEMBER 2009 |
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Share capital |
Share premium |
Merger reserve |
Reverse acquisition reserve |
Share option reserve |
Retained earnings |
Total |
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£ |
£ |
£ |
£ |
£ |
£ |
£ |
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Balance at 1 January 2008 |
1,896,786 |
145,643 |
637,500 |
602,413 |
- |
(1,593,692) |
1,688,650 |
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Changes in equity for 2008 |
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Loss for the year |
- |
- |
- |
- |
- |
(1,855,897) |
(1,855,897) |
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Movement in the year |
- |
90 |
- |
- |
2,801 |
- |
2,891 |
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Issue of shares |
1,583,200 |
(74,613) |
- |
- |
- |
- |
1,508,587 |
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Other movements |
- |
- |
- |
- |
- |
28,181 |
28,181 |
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───────── |
───────── |
───────── |
───────── |
───────── |
───────── |
───────── |
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Balance at 31 December 2008 |
3,479,986 |
71,120 |
637,500 |
602,413 |
2,801 |
(3,421,408) |
1,372,412 |
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Changes in equity for 2009 |
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Loss for the year |
- |
- |
- |
- |
- |
(1,443,091) |
(1,443,091) |
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Movement in the year |
- |
- |
- |
- |
7,646 |
- |
7,646 |
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Issue of shares |
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970,382 |
(2) |
- |
- |
- |
- |
970,380 |
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Other movements |
- |
- |
- |
- |
- |
- |
- |
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───────── |
───────── |
───────── |
───────── |
───────── |
───────── |
───────── |
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Balance at 31 December 2009 |
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4,450,368 |
71,118 |
637,500 |
602,413 |
10,447 |
(4,864,499) |
907,347 |
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═════════ |
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VALIRX PLC |
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CONSOLIDATED BALANCE SHEET |
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AS AT 31 DECEMBER 2009 |
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2009 |
2008 |
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£ |
£ |
£ |
£ |
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ASSETS |
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Non current assets |
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Intangible assets |
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1,466,297 |
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1,421,207 |
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Property, plant and equipment |
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8,039 |
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9,608 |
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Financial assets: available-for-sale investments |
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- |
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240,737 |
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───────── |
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───────── |
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1,474,336 |
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1,671,552 |
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───────── |
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───────── |
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Current assets |
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Stocks |
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15,659 |
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- |
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Trade and other receivables |
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159,879 |
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94,159 |
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Cash and cash equivalents |
15,911 |
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15,722 |
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───────── |
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───────── |
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191,449 |
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109,881 |
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LIABILITIES |
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Current liabilities |
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Trade and other payables |
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(712,254) |
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(388,850) |
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Borrowings |
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(46,184) |
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(20,171) |
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───────── |
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Net current liabilities |
(566,989) |
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(299,140) |
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───────── |
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───────── |
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Net assets |
907,347 |
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1,372,412 |
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═════════ |
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SHAREHOLDERS' EQUITY |
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Called up share capital |
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4,450,368 |
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3,479,986 |
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Share premium |
71,118 |
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71,120 |
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Merger reserve |
637,500 |
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637,500 |
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Reverse acquisition reserve |
602,413 |
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602,413 |
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Share option reserve |
10,447 |
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2,801 |
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Profit and loss account |
(4,864,499) |
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(3,421,408) |
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───────── |
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───────── |
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Total shareholders' equity |
907,347 |
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1,372,412 |
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═════════ |
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S Vainikka |
G Morris |
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Director |
Director |
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VALIRX PLC |
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CONSOLIDATED CASH FLOW STATEMENT |
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FOR THE YEAR ENDED 31 DECEMBER 2009 |
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2009 |
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2008 |
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£ |
£ |
£ |
£ |
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Cash outflows from operating activities |
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(1,017,395) |
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(791,810) |
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Taxation |
93,818 |
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- |
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Investing activities |
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Interest received |
55 |
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5,092 |
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Interest paid |
(3,180) |
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(2,725) |
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Payments to acquire intangible assets |
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(65,512) |
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(80,590) |
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Payments to acquire tangible assets |
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(3,990) |
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(6,118) |
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Cost of minority interest share in subsidiary undertaking |
- |
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(31,988) |
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Cash flows used in investing activities |
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(72,627) |
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(116,329) |
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Financing activities |
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Issue of ordinary share capital |
970,382 |
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893,200 |
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Cost of share issue |
(2) |
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(74,523) |
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Capital element of hire purchase contracts |
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(1,647) |
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- |
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───────── |
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───────── |
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Net cash generated from financing activities |
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968,733 |
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818,677 |
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───────── |
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───────── |
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Net decrease in cash and cash equivalents |
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(27,471) |
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(89,462) |
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Cash and cash equivalents at beginning of period |
(1,187) |
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88,275 |
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───────── |
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Cash and cash equivalents at end of period |
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(28,658) |
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(1,187) |
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VALIRX PLC |
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NOTES TO THE CASH FLOW STATEMENT |
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FOR THE YEAR ENDED 31 DECEMBER 2009 |
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1 |
Cash flows from operating activities |
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2009 |
2008 |
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£ |
£ |
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Operating loss |
(1,362,652) |
(1,225,915) |
|
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Depreciation of tangible assets |
5,148 |
5,302 |
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Amortisation of intangible assets |
20,422 |
14,158 |
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(Increase)/decrease in stocks |
(15,659) |
- |
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Decrease in debtors |
3,885 |
59,146 |
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Increase/(decrease) in creditors within one year |
323,404 |
295,440 |
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Other non-cash movements |
411 |
57,258 |
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Share option charge |
7,646 |
2,801 |
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─────── |
─────── |
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Cash outflows from operating activities |
(1,017,395) |
(791,810) |
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═══════ |
═══════ |
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2 |
Cash and cash equivalents |
1 January 2009 |
Cash flow |
31 December 2009 |
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£ |
£ |
£ |
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Net cash: |
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Cash at bank and in hand |
15,722 |
189 |
15,911 |
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Bank overdrafts |
(16,909) |
(27,660) |
(44,569) |
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─────── |
─────── |
─────── |
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(1,187) |
(27,471) |
(28,658) |
|
|
|
|
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Notes to the Financial Statements
1. Accounting policies and basis of information
The financial information contained in this document does not constitute statutory financial statements within the meaning of section 434 of the Companies Act 2006. The figures for the year ended 31 December 2009 have been extracted from the audited statutory financial statements. The financial statements for the year ended 31 December 2009 received an unqualified auditors' report which did not contain a statement under section 498 (2) or (3) of the Companies Act 2006.