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Share Name | Share Symbol | Market | Type |
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Avino Silver and Gold Mines Ltd | AMEX:ASM | AMEX | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 1.77 | 66 | 10:41:53 |
RNS Number:8913P Antisoma PLC 18 September 2003 Antisoma's preliminary results for the year ended 30 June 2003 18 September 2003, London, UK: Antisoma plc (LSE: ASM), the biopharmaceutical company specialising in novel anti-cancer drugs, today announces its preliminary results for the year ended 30 June 2003. Highlights - a year of transformation Ground-breaking alliance formed with Roche * Injection of #27.3 million cash and reduced cash burn * Potential for future milestone and royalty payments * Clear route to market established for products Existing pipeline advanced * Lead product R1549 close to completing pivotal efficacy study * Broad development of R1550 begun with breast cancer study Pipeline strengthened by new addition * Licensing of telomerase inhibitor programme from Cancer Research Technology Ltd (in September 2003) Financial highlights * Full-year net loss reduced significantly to #3.3 million (2002: #13.2 million) * Revenues increased substantially to #11.8 million (2002: #2.2 million) * Cash and cash equivalents at 30 June 2003 of #34.0 million (2002: #18.9 million) Commenting on the results, Glyn Edwards, Chief Executive Officer of Antisoma, said: "Antisoma has achieved a step change in its position over the past 12 months. Formation of a broad strategic alliance with Roche has opened up a clear route to market for our products and greatly improved our financial position, leaving us well placed to exploit our maturing pipeline and to build on our proven track record as a seeker and developer of innovative approaches to the treatment of cancer. We are now only months away from knowing the result of our pivotal study of R1549 in ovarian cancer." Enquiries: Antisoma plc Tel: +44 (0)20 8799 8200 Glyn Edwards Chief Executive Officer Raymond Spencer, Chief Financial Officer Financial Dynamics Tel: +44 (0)20 7831 3113 Jonathan Birt The full text of Antisoma's annual report will be available on the Company website http://www.antisoma.com from 30 September 2003. Except for the historical information presented, certain matters discussed in this statement are forward looking statements that are subject to a number of risks and uncertainties that could cause actual results to differ materially from results, performance or achievements expressed or implied by such statements. These risks and uncertainties may be associated with product discovery and development, including statements regarding the company's clinical development programmes, the expected timing of clinical trials and regulatory filings. Such statements are based on management's current expectations, but actual results may differ materially. Joint Chief Executive and Chairman's Statement Antisoma has emerged from the past year in the strongest and most promising position since its inception. In the 12 months to the end of June we made significant progress on many fronts: finding a major corporate partner to commercialise our products, building a solid financial position and keeping a tight control of our costs. Most importantly, we achieved all this while continuing the key task of moving our product pipeline forward. We are now very close to completing the pivotal study for our lead product, R1549 (formerly Pemtumomab), in ovarian cancer. The climate in the biotechnology sector has remained tough this year, particularly with regard to fundings and flotations. The companies most likely to succeed in this environment are those with a broad product pipeline, a clear business strategy and solid finances. The Directors believe that our achievements over the past year take Antisoma a long way towards reaching these goals. Partnership with Roche In November 2002, we announced the formation of a ground-breaking strategic alliance with Roche, one of the world's leading companies in the cancer area. The alliance applies the development, manufacturing and commercial capabilities of Roche to facilitate the rapid commercialisation of Antisoma's products. We see the formation of this alliance as a major endorsement of our business model and a recognition of our successful track record in acquiring and developing attractive new approaches to cancer therapy. The alliance makes Roche the worldwide development and marketing partner for the three products we currently have in clinical trials, and provides Roche with the opportunity to opt in to all further oncology drugs starting trials over a five-year period. Antisoma has received substantial upfront payments and will benefit from milestone payments when products reach key stages in development, as well as royalties on product sales. Pipeline development In July we announced that the independent Data Safety Monitoring Committee (DSMC) for the pivotal phase III (SMART) trial of R1549 in ovarian cancer had provided us with a revised estimate for the completion date of the trial, which is now expected between December 2003 and February 2004. Roche is preparing for the commercialisation of the drug, and together Antisoma and Roche are taking the steps necessary to ensure that we are well placed to file for approval in the US and Europe on receipt of a positive result. We expect to announce the key findings of the trial during H1 2004, following analysis of the data. SMART (Study of Monoclonal Antibody Radioimmuno-Therapy) is one of four ongoing studies on R1549. We are also conducting two other ovarian cancer trials, MIDAS and TOPDOC, which will provide important supplementary evidence on the biodistribution, activity and tolerability of R1549. The fourth study is a pilot phase II study in gastric cancer. Preliminary results were reported from the gastric study during 2002 and final results are expected before the end of 2003. There has been significant news on each of our other clinical products. In May we initiated a new phase I study of our vascular targeting agent AS1404 (DMXAA) in order to define appropriate doses for use in the phase II programme. In June we began a new phase I study of R1550 (formerly Therex) in locally advanced or metastatic (spreading) breast cancer, with initial recruitment taking place at the UCLA's Jonsson Comprehensive Cancer Center in California. Roche plans to conduct all future trials on R1550 in order to allow the broad potential of this agent to be fully investigated. In August 2003 we announced that we had decided not to pursue further development of AS1403 (formerly TheraFab), which was in phase I development, following results from a biodistribution study. This decision is in line with our policy of putting resources behind products with the clearest commercial potential. Our preclinical portfolio also continues to develop. We recently announced the acquisition of rights to a programme based on inhibition of telomerase, an enzyme crucial to the ability of cancer cells to divide unchecked by normal controls. Our established targeted apoptosis programme is advancing well, and in April the first animal data were presented on AS1406 (an antibody targeted RNase, formerly TheraNase), which is the subject of a collaborative agreement with the prestigious US National Institutes of Health. The data showed encouraging anti-tumour effects in both breast cancer and lymphoma models. Financial Highlights The alliance with Roche has transformed Antisoma's financial position and prospects. We ended the year with #34.0 million in cash and short-term investments compared with #18.9 million last year. This reflects the substantial upfront payments made by Roche on formation of the alliance: #4.15 million for an approximately 9% post-deal shareholding in Antisoma and a further $37 million (#23.2 million) for rights to our existing clinical pipeline and an option on oncology products progressing to trials in the next five years. We are accounting for the revenue from the Roche alliance in line with our anticipated achievement of the development steps covered by the payments. We therefore recognised #5.3 million from the upfront payments during the year, and this contributed to an increase in total revenues to #11.8 million, from #2.2 million last year. Also important in this increase was #5.2 million received from Roche in relation to development costs on R1549 and R1550, which are now paid in full by Roche. The increase in our revenues contributed to a reduction in our losses to #3.3 million for 2003, compared with #13.2 million for 2002. Losses per share were 1.5p, compared with 10.8p in 2002 and 9.3p in 2001. Net operating loss in the second half of the financial year has fallen significantly to #0.3 million from #5.1 million in the first half and #7.3 million in the corresponding period last year. Ongoing losses reflect investment in our pipeline at levels exceeding revenues, as expected for a biopharmaceutical company at our stage of development. Our total operating costs rose from #15.7 million last year to #17.2 million in 2003, as we continued to pursue a substantial programme of clinical trials and other work pertinent to the advancement of our drugs. A breakdown of operating expenses is provided below: (# million) Year ended 30 June 2003 2002 2001 R1549 costs 5.0 4.9 4.4 Other development costs 8.0 7.0 4.8 Administrative costs 4.2 3.8 3.4 Total 17.2 15.7 12.6 The continuation of R1549 development costs during 2003 (#5.0 million) reflects ongoing costs of recruiting and following up patients in the phase III ovarian study (SMART), additional clinical studies (MIDAS and TOPDOC), and other costs such as manufacturing associated with preparation for marketing. Other development costs increased by #1.0 million to #8.0 million for the year ended 30 June 2003, due principally to manufacturing and other costs associated with the start of new clinical trials on R1550 (formerly Therex) and AS1404 (DMXAA). Administrative costs for the year increased to #4.2 million from #3.8 million due to the costs associated with the completion of the deal with Roche. Administrative costs also include a net charge for employer's National Insurance contributions on share options of #5,000 (2002: # nil). Net cash inflow from operating activities in the year was #9.2 million. In comparison, net cash outflows in the years to 30 June 2002 and 30 June 2001 were #11.8 million and #7.0 million, respectively. The net outflow of cash from our operating activities over the past three years has been due principally to our operating losses. Results of operations - quarter ended 30 June 2003 Revenues for the quarter ended 30 June 2003 were #4.7 million (Q4 2002: #0.7 million). Operating costs for the quarter ended 30 June 2003 were #4.9 million (2002: #4.4 million) and included investment in research and development of #3.9 million (2002: #3.2 million). The cash outflow from operating activities for the final quarter was #1.1 million compared to #7.1 million during Q3. Profits for the quarter ended 30 June 2003 were #95,000 (Q4 2002: #3.5 million loss). For the quarter ended 30 June 2003, the result per share was 0.0p (loss per share Q4 2002:1.7p). De-listing from NASDAQ Europe market Our shares were voluntarily de-listed from NASDAQ Europe on 10 September 2003 in anticipation of this market's closure in November 2003. Our shares will continue to be traded on the London Stock Exchange. Management changes We have continued to strengthen our management team, with the appointment of Dr Miroslav Ravic as Chief Clinical Officer demonstrating Antisoma's ability to attract leading industry talent. Miroslav joined us from the Japanese pharmaceutical group Eisai, where he was most recently Director of Clinical Research and Development, Europe. He has brought invaluable clinical development experience to Antisoma at an important stage of our growth. We were also pleased to announce the promotion of Dr Nigel Courtenay-Luck, a co-founder of Antisoma, to the position of Chief Scientific Officer. Nigel will continue to oversee preclinical drug development at Antisoma but will also take on a wider role, presenting the Company's science at key conferences and building on Antisoma's relationships with academic and commercial institutions. These are crucial to our continuing success at licensing in promising early-stage drugs. We have expanded our clinical and preclinical operations this year, taking on additional staff, and are currently extending our laboratory facilities within our St George's Hospital site in London. Outlook for the next 12 months We look forward to completing the phase III trial of R1549 by early next year. Antisoma and Roche will take the preparatory steps necessary to ensure that we are well placed to exploit a positive result. We also expect to receive further results from our pilot phase II study of R1549 in gastric cancer. While R1549 is clearly of great importance to the near-term future of the Company, we have worked continually to build a broad-based pipeline. We now have a substantial pipeline of products in development. In the coming year we intend to advance a further product, AS1405 (formerly AngioMab), into clinical trials. We expect to see the results from the ongoing trial of AS1404 and will continue, with Roche, the development of the programme to maximise the potential of R1550. We will also seek further opportunities to enhance our pipeline. Barry Price Glyn Edwards Chairman Chief Executive Officer Consolidated profit and loss account for the year ended 30 June 2003 2003 2002 2001 Unaudited Audited Audited #'000 #'000 #'000 Revenue 11,837 2,176 3,321 Operating expenses (17,212) (15,738) (12,621) ______ ______ ______ Operating loss (5,375) (13,562) (9,300) Interest receivable 978 382 666 Interest payable and similar charges - (11) (23) ______ ______ ______ Loss on ordinary activities before taxation (4,397) (13,191) (8,657) Taxation on ordinary activites 1,098 - - Loss on ordinary activities after taxation and retained loss for the year (3,299) (13,191) (8,657) ====== ====== ====== Loss per 1p share Basic and diluted 1.5p 10.8p 9.3p* ====== ====== ====== *Loss per share figures for 2001 have been restated to take account of the bonus element of the Rights Issue. The bonus arises because the rights were issued at a discount to market price. Consolidated balance sheet as at 30 June 2003 2003 2002 2001 Unaudited Audited Audited #'000 #'000 #'000 Fixed assets Tangible assets 263 230 372 ______ ______ ______ Current assets Debtors: Amounts falling due within one year 3,529 898 1,880 Amounts falling due after more than one year - - 13 ______ ______ ______ 3529 898 1,893 Short-term deposits 31,854 17,959 8,210 Cash at bank and in hand 2,141 920 876 ______ ______ ______ 37,524 19,777 10,979 Creditors: amounts falling due within one year (13,013) (4,866) (5,006) ______ ______ ______ Net current assets 24,511 14,911 5,973 ______ ______ ______ Total assets less current liabilities 24,774 15,141 6,345 Creditors: amounts falling due after more than one year (8,715) - - Provision for liabilities and charges (70) (101) ______ ______ ______ Net assets 15,989 15,141 6,244 ====== ====== ====== Capital and reserves Called up share capital 6,613 6,405 5,208 Share premium account 55,952 52,013 31,122 Other reserves 4,300 4,300 4,300 Profit and loss account (50,876) (47,577) (34,386) ______ ______ ______ Total shareholders' funds 15,989 15,141 6,244 ====== ====== ====== Shareholders' funds analysed as: Equity shareholders' funds 11,657 10,809 1,912 Non-equity shareholders' funds 4,332 4,332 4,332 ______ ______ ______ 15,989 15,141 6,244 ====== ====== ====== Consolidated cash flow statement for the year ended 30 June 2003 2003 2002 2001 Unaudited Audited Audited #'000 #'000 #'000 Net cash inflow/(outflow) from operating activities 9,185 (11,837) (6,962) ______ ______ ______ Returns on investments and servicing of finance Interest received 897 363 565 Interest paid and similar charges - (11) (23) ______ ______ ______ Net cash inflow from returns on investments and servicing of finance 897 352 542 ______ ______ ______ Net cash inflow from taxation 1,098 - - ______ ______ ______ Capital expenditure and financial investment Purchase of tangible fixed assets (212) (52) (162) Sale of tangible fixed assets 1 7 1 Purchase of intangible fixed assets - (397) (44) ______ ______ ______ Net cash outflow for capital expenditure and financial investment (211) (442) (205) ______ ______ ______ Net cash inflow/(outflow) before management of liquid resources and financing 10,969 (11,927) (6,625) ______ ______ ______ Management of liquid resources Purchase of current asset investments (13,895) (9,749) (3,960) ______ ______ ______ Financing Issue of shares 4,147 23,704 11,583 Expenses paid in connection with share issues - (1,965) (218) Repayment of principal under finance leases - (19) (77) ______ ______ ______ 4,147 21,720 11,288 ______ ______ ______ Increase in cash 1,221 44 703 ====== ====== ====== Notes to the financial statements for the year ended 30 June 2003 1. Basis of reporting The preliminary financial statements have been prepared in accordance with UK Generally Accepted Accounting Principles ("UK GAAP") on the basis of the accounting policies set out in the Group's 2002 statutory accounts. The statements were approved by the Board of Directors on 16 September 2003 and are unaudited. As set out in the Joint Chief Executive and Chairman's Statement the Company formed a strategic alliance with Roche resulting in upfront payments received of $37 million and #4.15 million for an approximately 9% post-deal shareholding in Antisoma. The Directors are confident that the Group has sufficient funds to meet the requirements of the business for the foreseeable future. The financial information in this preliminary statement is therefore prepared on a going concern basis. 2. Operating expenses 2003 2002 2001 Unaudited Audited Audited #'000 #'000 #'000 Administrative expenses 4,179 3,837 3,408 Research and development costs 13,033 11,901 9,213 ______ ______ ______ Net operating expenses 17,212 15,738 12,621 ====== ====== ====== 3. Reconciliation of operating loss to net cash flow from operating activities 2003 2002 2001 Unaudited Audited Audited #'000 #'000 #'000 Operating loss (5,375) (13,562) (9,300) Depreciation charge (net of disposals) 179 189 210 Amortisation of intangibles - 747 44 (Increase)/decrease in debtors (2,551) 1,012 (524) Increase/(decrease) in creditors 16,932 (223) 2,608 ______ ______ ______ Net cash inflow/(outflow) from operating 9,185 (11,837) (6,962) activities ______ ______ ______ 4. Reconciliation of net cash flow to movement in net funds 2003 2002 2001 Unaudited Audited Audited #'000 #'000 #'000 Increase in cash for the year 1,221 44 703 Cash outflow from purchase of current asset investments 13,895 9,749 3,960 Cash outflow from repayment of finance leases - 19 77 ______ ______ ______ Movement in net funds in the year 15,116 9,812 4,740 Net funds at start of the year 18,879 9,067 4,327 ______ ______ ______ Net funds at end of the year 33,995 18,879 9,067 ______ ______ ______ The financial information set out in the announcement does not constitute the Group's statutory accounts for the years ended 30 June 2003, 2002 or 2001 within the meaning of section 240 of the Companies Act 1985. The financial information for the years ended 30 June 2002 and 2001 is derived from the statutory accounts for those years which have been delivered to the Registrar of Companies and which are available on request from the Company Secretary, Antisoma plc, West Africa House, Hanger Lane, London, W5 3QR. The auditors' report on those accounts was unqualified and did not contain a statement under either section 237 (2) or 237 (3) of the Companies Act 1985. The statutory accounts for the year ended 30 June 2003 will be finalised on the basis of the financial information presented by the Directors in this preliminary announcement and will be delivered to the Registrar of Companies following the Company's Annual General Meeting. This information is provided by RNS The company news service from the London Stock Exchange END FR VDLFFXKBLBBZ
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