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Share Name | Share Symbol | Market | Type |
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Telkom Indonesia Persero Tbk PT | TG:PTI | Tradegate | Ordinary Share |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 17.10 | 17.00 | 17.10 | 0.00 | 17:37:23 |
RNS Number:8877L Protherics PLC 04 June 2003 4 June 2003 PROTHERICS PLC PRELIMINARY RESULTS FOR THE YEAR ENDED 31 MARCH 2003 Protherics PLC ("Protherics"), the international biopharmaceuticals company, today announces its preliminary results for the year ended 31 March 2003. HIGHLIGHTS * Turnover up 64% to #11.3 million (#6.9million last year) on continuing operations * CroFab sales up 70% to #8.5 million (#5 million last year) * DigiFab completes successful first year with #1.2 million sales * Operating loss decreased to #0.6 million from #2.2 million on continuing operations * Offer for Enact Pharma plc, announced 2 May 2003, declared unconditional with regard to acceptances on first closing date, 28 May 2003. Commenting on the results, Stuart Wallis, Chairman, said: "Building a profitable business is Protherics' first objective. This reduces risk in our business and to our shareholders. It provides the funding for our ongoing research and development programmes in large and exciting therapeutic areas, and provides us with the financial cushion to acquire products and businesses in later stage development where the risk of failure is lower. "Biotechnology is potentially very rewarding and yet for shareholders in many companies it has been a highly volatile experience. In Protherics, we are working to reduce risk and to build a stable, diverse revenue stream, which, in turn will fund an exciting research and development programme. "The quality of our current institutional investor base is testimony to the progress we continue to make. We aim to build on this, to create value for investors in Protherics in line with our own belief and expectations." For further information contact: Protherics PLC +44 (0) 20 7246 9950 Andrew Heath, Chief Executive +44 (0) 7919 480510 (mobile) Barry Riley, Finance Director +44 (0) 1928 518000 The Maitland Consultancy +44 (0) 20 7379 5151 Brian Hudspith Simone Cheetham Protherics PLC Protherics PLC was formed in September 1999 from the merger of Proteus International plc and Therapeutic Antibodies Inc. Protherics is an international biopharmaceutical company, whose platform technology is the development and production of immunotherapeutics. The Company's ordinary shares are listed on the Official List of the UK Listing Authority and are traded on the London Stock Exchange. An electronic version of this will be available at: www.protherics.com This release, and oral statements made from time to time by Company representatives concerning the subject matter hereof, may contain so-called "forward looking statements". These statements can be identified by introductory words such as "expects", "plans", "will", "estimates", "forecasts", "projects", words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are discussing the Company's growth strategy, operating and financial goals, plans relating to regulatory submissions and approvals and development programs. Many factors may cause actual results to differ from the Company's forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Those and other risks are described in the Company's filings with the Securities and Exchange Commission, copies of which are available from the SEC or may be obtained upon request from the Company. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. CHAIRMAN'S STATEMENT In 2002, the value of publicly traded biotechnology companies almost halved. Although a small recovery, particularly in larger US companies, has taken place over the past few months, 2002 was not a good year for the sector which was rocked by scandal (ImClone), bankruptcy (22 biotechnology bankruptcies in the US in 2002), and drug failures late in development. Venture capitalists investing in early stage companies must now look far beyond the 5 to 7 year horizon to expect a payback. For the major pharmaceutical companies, the situation is not much better. In 2001, of 32 new medicines approved by the FDA, only 5 were new molecules - and none of these originated from those largest companies. The top 14 pharmaceutical companies spent over 65% ($29 billion) of the total research and development expenditure of $44.5 billion, yet obtained just 26% of FDA approvals. What does this environment mean for Protherics? Building a profitable business is Protherics' first objective. This reduces risk in our business and to our shareholders. It provides the funding for our ongoing research and development programmes in large and exciting therapeutic areas, and provides us with the financial cushion to acquire products and businesses in later stage development where the risk of failure is lower. We are pleased to report that in the last six months of the financial year to 31 March 2003, Protherics traded profitably. Our objective to be a viable, self-sustaining biopharmaceutical company is now within our grasp. This important milestone is the foundation upon which we will continue to build our business. In this past year we have worked hard to reduce our operating expenses. We took an opportunity to buy back the rights for the second tranche of convertible debt (where Citadel was the lead investor) for #375,000, removing concerns expressed to us by our major shareholders. The result for the full year was a loss after tax of #238,000 which was obtained despite in excess of #3 million of sales, planned for the end of the year to 31 March 2003, moving forward into the current year. This strong result was achieved through better than projected reductions in cost of goods, and continued tight cost controls. On 2 May 2003, we announced that we had reached an agreement with Enact Pharma plc ("Enact") on the terms of a recommended offer to acquire that company. On 28 May 2003, we declared the offer unconditional as to acceptances and we expect to declare the offer wholly unconditional in the first half of June. This acquisition provides Protherics with a late stage product, Voraxaze, used to manage toxicity from methotrexate, a widely used cancer drug. We should start to generate revenues from named patient sales of Voraxaze in this current financial year. Voraxaze leverages our regulatory and manufacturing skills, and should provide significant revenue growth in the near to medium term, with a FDA approval anticipated in 2005. We also acquire a project (NQO2) aimed at selectively enabling patients with solid cell cancers - such as colorectal and liver tumours - to be treated without the adverse events usually associated with chemotherapy. This acquisition is accompanied by an underwritten cash placing and open offer issuing new ordinary shares to raise #3 million to provide adequate working capital to fund the Enact acquisition. The new ordinary shares were admitted to trading on the London Stock Exchange today. Despite current valuations, biotechnology sector revenues are forecast to grow from their present $36.1 billion to $61.8 billion in 12 years, a compound annual growth rate of 12%. At Protherics, we believe that our late stage product portfolio will enable us to share in this growth, to contribute to the funding for our very exciting pipeline, and to become increasingly profitable. Biotechnology is potentially very rewarding and yet for shareholders in many companies it has been a highly volatile experience. In Protherics, we are working to reduce risk and to build a stable, diverse revenue stream, which, in turn will fund an exciting research and development programme. The quality of our current institutional investor base is testimony to the progress we continue to make. We aim to build on this, to create value for investors in Protherics in line with our own belief and expectations. CHIEF EXECUTIVE'S REVIEW The business environment for biotechnology companies has been quite difficult this past year. For many companies, the primary objective has been to simply avoid running out of cash, and as fund raising in the sector has slowed, R&D programmes have been cut and headcounts reduced. Protherics' situation is different. We are now making the appropriate investments to reduce our cost of goods and to support our own research, in particular our angiotensin programme, and those projects recently obtained through the acquisition of Enact. Operations We continue to invest in process improvements at our operations in Wales and Australia. These have already generated substantially increased output at significantly reduced costs per unit. Year on year, the cost of producing a vial of CroFabTM has been reduced by 28%. Our plans for the current year include continued cost reductions and increases in output. Beyond this, we plan a more fundamental re-engineering of the process which, while needing regulatory approvals, can, over two to three years, deliver even more dramatic improvements. Risk management remains a high priority. Supplies of sheep serum from our second (external) supplier in Tasmania have now received FDA approval, and work is well underway in qualifying a second supplier of filling/freeze drying capability. PORTFOLIO REVIEW Marketed Products CroFabTM Demand for CroFabTM , our treatment for rattlesnake bites, which is marketed by Altana's US subsidiary, Fougera, continues to increase as its use expands into the earlier treatment of milder bites and also into Copperhead bites, a previously un-served market. We estimate that the market opportunity (shared with our distributor) remains in the range of $80 million per annum. Production capacity has doubled over the past twelve months. Batch yields are increasing and significant progress has been made in reducing our cost of goods. We expect a further significant improvement in this current financial year. With a strong order book, we continue to invest in production capability. This will enable us to increase throughput, thus reducing work in progress but increasing stocks of finished goods. The ability to supply the market from inventory will enable us to smooth supply versus demand, thereby avoiding the roll over of revenues from one financial year to another. CroFabTM revenues were #8.5 million, up from #5.0 million the previous year. With the release of 3 batches delayed from March, we can expect strong sales in first half of 2003. DigiFabTM DigiFabTM , a treatment for Digoxin overdose and our second product launched in the US, has had an excellent start in its first full year, with sales of #1.2 million. Our partner Altana has orders in hand that represent a share of more than half of the market, and we have increased production of DigiFabTM to meet this demand. ViperaTabTM Sales of ViperaTabTM, approximately #200,000, were affected by high stocks being carried forward in response to strong sales (#350,000) in the prior year. We anticipate a growth in sales in the current year and are actively seeking to expand the product beyond Scandinavia and into the rest of Europe, through the appointment of a marketing partner to assist with product registration in this region. Although this is not a large market, high margins mean that ViperaTabTM is potentially capable of generating an attractive return. Prion recognition (BSE testing) Royalties from our licensee, Enfer, remained in line with the prior year, as increasing revenues from Europe offset reductions in the Irish market. Abbott, Enfer's distributor in Europe, has launched the test in Germany, and we expect further penetration both in Germany and in other countries as annual contracts are renewed, although price competition may offset some of the volume gains. Our intellectual property position in abnormal prion recognition is strong, and discussions continue with potential partners on licensing for use in human testing, such as screening of blood donors. Research and Development Angiotensin Vaccine A vaccine treatment for high blood pressure is attractive because of the high proportion of patients who fail to have their blood pressure adequately controlled by existing tablet-based treatment. This is generally because of poor compliance. Patients commonly suffer no symptoms and often neglect or forget to take tablets. A small Phase II study has already shown statistically significant effects on levels of hormones involved in the regulation of blood pressure and fluid balance. One of these hormones, aldosterone, is increasingly seen as an excellent therapeutic target in its own right for use in the treatment of congestive heart failure and kidney failure, both very large markets. The primary market for high blood pressure alone is in excess of $30 billion per annum. Currently, a series of small formulation studies involving different combinations of vaccine and proprietary adjuvants is under way to select the best possible combination, before undertaking a larger proof of concept Phase II study. This is planned to start early in 2004 and, if successful, we will have a valuable product for outlicensing to a major pharmaceutical company. CytoFabTM The treatment of sepsis, a life threatening condition resulting from severe infection, remains difficult. The first drug approved for this condition - Eli Lilly's Xigris(R) - has not generated the level of sales expected because of its safety profile. A market in excess of $1 billion per annum remains to be captured by a more widely prescribed product. CytoFabTM achieved its clinical endpoints in a Phase IIb study, reducing the time patients spend in intensive care. We therefore remain confident of the prospects for this product and continue discussions with prospective partners to fund the large Phase III study required for registration. In the meantime, we are investing modest resources in developing and optimising the production process. VEGF Vaccine VEGF (vascular endothelial growth factor) promotes angiogenesis, the development of new blood vessels. This is understood to be important in the spread and growth of secondary cancers. Genentech have recently announced very encouraging results in a Phase III study of their anti-VEGF monoclonal antibody in metatstatic colorectal cancer, thus providing the first validation in patients of an anti-VEGF therapy. Our vaccine has shown encouraging results in preclinical studies. We are currently carrying out formulation studies with a target of a first clinical study in patients in early 2004. Acquired Products The acquisition of Enact announced on 2 May 2003, brings with it both a high margin, late stage product, Voraxaze, with revenues anticpated to start in the current financial year, and an earlier stage product, NQO2, with the potential to be out-licensed within two years. Voraxaze Voraxaze (Carboxypeptidase G2) is a new drug for the treatment of methotrexate toxicity during cancer therapy. Voraxaze can very rapidly reduce dangerously elevated serum methotrexate levels. Methotrexate is a widely used chemotherapeutic agent that can cause kidney damage in a predictable number of cases. The market potential, when used as a rescue therapy, as well as for the management of patients with signs of kidney damage during methotrexate treatment, is in excess of #80 million per annum. The availability of an effective antidote opens up a much larger market opportunity, as high dose treatment protocols for methotrexate are adapted to accommodate Voraxaze. Clinical trials involving over 200 patients have been completed in Europe and the USA. Orphan drug status has been granted in Europe and is expected in the USA. Revenues from named patient sales are expected in the current year in Europe, with marketing approval in Europe anticipated in 2004, and FDA approval for US marketing expected in 2005. NQO2 A common problem with the treatment of cancer by chemotherapy is that the drugs used, because of their ability to kill cells (cytotoxicity), also damage healthy, non-cancerous cells. NQO2 is an enzyme that is over-expressed in certain tumour types (particularly liver and colorectal cancers). Normally, the enzyme is latent in these cells. However, Enact scientists have discovered that a co-factor (EP-0152R) activates NQO2. In its activated form, NQO2 converts a pro-drug (CB1954) to its cytotoxic form, thus selectively killing the tumour cells containing the enzyme, and therefore avoiding harm to healthy, non-cancerous cells. A Phase I/II trial is planned for 2004. Good clinical data should result in a highly attractive licensing opportunity for a major pharmaceutical company. The worldwide market for an effective treatment for liver cancer is estimated at #2.8 billion per annum. Other Products A further vaccine project to combat kidney failure is progressing through pre-clinical studies. Other targets are under investigation in the areas of inflammation and metabolic control. The two GnRH vaccines (licensed to ML Laboratories plc for human use in prostate cancer, and to Janssen Animal Health for fertility control of animals) have not been progressed further by the licensees. We are considering the possibility of re-acquiring these products, but do not plan to devote significant resources to them. Looking Forward The acquisition of Enact provides an opportunity to add to revenues in the short-to-medium term, and may enable us to establish a small, focused team to market Voraxaze in the US. Furthermore, we have acquired an exciting new technology platform for the management of solid cell tumours which we believe can provide us with a significant outlicensing agreement in 1 to 2 years. With strong orders for our existing lead products, CroFabTM and DigiFabTM and the prospect of further manufacturing cost reductions, we look forward to the future confident in the belief that our strategy of funding an exciting research and development portfolio from internally generated revenues is delivering success FINANCIAL REVIEW The results from continuing operations continue the trend of year-on-year improvements seen since Protherics was formed in September 1999. Turnover for the year to 31 March 2003 increased to #11.3 million against #6.9 million from continuing operations in the prior year. In the same period, CroFab TM sales increased to #8.5 million from #5 million. DigiFabTM contributed sales of #1.2 million in its first full year, against #0.1 million in the prior year, while revenues from BSE testing were #1.3 million compared to #1.4 million, with increased testing in Europe and reduced levels in Ireland. ViperaTab(R) sales reduced slightly to #0.2 million from #0.3 million while other income was #0.1 million in both years. Revenues from discontinued operations (the Computer-aided Molecular Design "CAMD" division sold in July 2001) were #1.0 million in the year to 31 March 2002. Cost of sales, at #5.9 million compares with #4.7 million in the prior year. The modest increase of #1.2 million year-on-year supported additional sales from manufactured products (excluding BSE licensing revenues and other income) of #4.5 million. This resulted in a gross margin on manufactured products of 40.4% against 13.0% in the prior year, underlining the progress made in cost reduction and process optimisation. Research and development expenditure was #1.6 million for the year, compared to #0.3 million on continuing operations in the year to 31 March 2002. However, the prior year benefited from an exceptional credit of #0.7 million as provisions against stocks were released following FDA approval of DigiFabTM. The underlying increase year on year is therefore #0.6 million, largely representing increased spending on the Angiotensin Vaccine. Other administration costs on continuing operations, at #4.3 million showed a marginal increase on the prior year figure of #4.2 million. The operating loss for the year has decreased to #0.6 million from #2.2 million (from continuing operations) in the prior year. A one-off profit from the disposal of the CAMD division of #5.0 million in the prior year resulted in a profit before and after tax of #2.9 million. In the year to 31 March 2003, tax credits on research and development and deferred tax produced a benefit of #0.4 million and reduced the pre-tax loss of #0.6 million to #0.2 million after tax. Balance sheet strength was maintained in the year, with net assets of #10.3 million at 31 March 2003 compared to #10.1 million at 31 March 2002. Investment at our operations in Wales and Australia increased fixed assets to #6.2 million from #5.3 million at 31 March 2002, and further investment is planned over the next two years as we continue to improve manufacturing efficiencies, drive down costs and increase throughput. As expected, the second half of the year was stronger than the first. The production necessary to meet this demand was supported by investment in fixed assets and resulted in increased stocks and debtors. Stocks increased to #7.1 million from #4.0 million at the previous year end, as high levels of stocks were awaiting release by the FDA. In the first two months of the current financial year, goods with a sales value of over #3 million have been released and sold, giving an excellent start to the current year. Debtors also increased (to #3.5 million from #2.0 million) as a result of heavy shipments in the final quarter of the year. Creditors due within one year increased to #8.5 million from #6.2 million due to advance payments on orders received and generally higher levels of manufacturing activity. Amounts due after more than one year reduced to #0.7 million from #1.1 million as some longer term loans and leasing arrangements were repaid. As a result of this investment, cash levels have reduced from #6.2 million at the prior year end to #2.8 million. Working capital levels are expected to decline as payments for goods supplied are received from our distributor, Altana. Net cash outflow from operations remained similar to the prior year (#1.7 million compared to #1.6 million in the prior year) reflecting the substantial reduction in operating loss offset by the increased investment in working capital referred to above. Cash outflow from capital investment increased from #0.8 million to #1.8 million as a result of the first part of the fixed asset investment programme now being implemented in Wales and Australia. Summary The strong performance in the last six months of the year (despite the delay in release of some product until the current year) has delivered a profitable second half. With maintained balance sheet strength, we look forward to the future from a sound foundation. Protherics PLC CONSOLIDATED PROFIT & LOSS ACCOUNT (UNAUDITED) For the year ended 31 March 2003 Year ended Year ended 31 March 2002 31 March Continuing Discontinued 31 March 2003 operations Operations 2002 #'000 #'000 #'000 #'000 Turnover 11,270 6,961 963 7,924 Cost of Sales (5,920) (4,649) - (4,649) Gross profit 5,350 2,312 963 3,275 Administration expenses Research & development expenses (note 3) (1,591) (295) (588) (883) Other administration expenses (4,363) (4,182) (312) (4,494) (5,954) (4,477) (900) (5,377) Operating (loss) / profit (604) (2,165) 63 (2,102) Profit on sales of discontinued operations (note 4) - - 5,032 5,032 (Loss) / profit on ordinary activities before (604) (2,165) 5,095 2,930 interest Interest receivable 100 139 Interest payable (95) (202) (Loss) / profit on ordinary activities before (599) 2,867 taxation Taxation 361 - (Loss)/profit on ordinary activities after taxation (238) 2,867 Basic and fully diluted (loss) / earnings per share (pence) (note 2) (0.13) 1.61 The results for the year ended 31 March 2003 relate to continuing operations. The result for the year has been calculated on the historical cost basis. CONSOLIDATED STATEMENT OF TOTAL RECOGNISED GAINS AND LOSSES (UNAUDITED) For the year ended 31 March 2003 Group 2003 2002 #'000 #'000 (Loss) / profit for the financial year (238) 2,867 Currency translation differences on foreign currency equity investments 435 18 Total recognised gains in the year 197 2,885 CONSOLIDATED BALANCED SHEET (UNAUDITED) at 31 March 2003 2003 2002 #'000 #'000 Fixed assets Intangible fixed assets 873 1,004 Tangible fixed assets 5,351 4,264 6,224 5,268 Current assets Stock 7,085 3,979 Debtors 3,460 1,972 Cash at bank and in hand 2,756 6,211 13,301 12,162 Creditors: Amounts falling due within one year (8,470) (6,183) Net current assets 4,831 5,979 Total assets less current liabilities 11,055 11,247 Creditors: Amounts falling due after more than one year: (717) (1,106) Net assets 10,338 10,141 Capital and reserves Called up equity share capital 3,765 3,765 Share premium account 63,350 63,350 Other reserves 51,163 51,163 Profit and loss account (107,940) (108,137) Equity shareholders' funds 10,338 10,141 CONSOLIDATED CASH FLOW STATEMENT (UNAUDITED) For the year ended 31 March 2003 2003 2002 #'000 #'000 #'000 #'000 Net cash outflow from operating activities (1,723) (1,635) Returns on investment and servicing of finance Interest received 100 139 Finance lease interest paid (12) (15) Other interest paid (83) (99) Net cash inflow / (outflow) from returns on investments and servicing of finance 5 25 Taxation UK Corporation tax received 582 - Net cash inflow from taxation 582 - Capital expenditure and financial investment Payments to acquire tangible fixed assets (1,862) (657) Payments to acquire intangible fixed assets - (172) Proceeds from the sale of tangible fixed assets 22 37 Net cash outflow from capital investment and financial (1,840) (792) investment Acquisitions and disposals Sale of business - 5,823 Net cash inflow from acquisitions and disposals - 5,823 Net cash (outflow) / inflow before management of liquid (2,976) 3,421 resources and financing Management of liquid resources Cash withdrawn from money market deposits - 1,686 Net cash inflow from management of liquid resources - 1,686 Financing Issue of share capital, net - (2) Repayment of loans (484) (345) Repayment of finance leases and hire purchase agreements (51) (75) Net cash (outflow) from financing (535) (422) (Decrease) / Increase in cash during the year (3,511) 4,685 RECONCILIATION OF OPERATING LOSS TO NET CASH OUTFLOW FROM OPERATING ACTIVITIES (UNAUDITED) 31 March 31 March 2003 2002 #'000 #'000 Operating loss (604) (2,102) Depreciation and amortisation 1,025 958 (Profit) / Loss on disposal of tangible fixed assets (2) 16 Deferred grant income (101) (55) Grant received 122 - Increase in stocks (3,092) (2,295) Increase in debtors (1,677) (388) Increase in creditors 2,606 2,264 (Profit) on sale of current asset investments - (33) Net cash outflow from operating activities (1,723) (1,635) NOTES TO THE PRELIMINARY RESULTS 1. The financial information set out above is an abridged version of the Group's full accounts for the year ended 31 March 2003. The full accounts for 2003 have not been filed with the Registrar of Companies and have not been reported on by the Group's auditors. The full accounts for the year ended 31 March 2002 received an unqualified report and have been filed with the Registrar of Companies. 2. Basic and fully diluted earnings per share are based on attributable losses of #238,000 (2002: profits of #2,867,000) and on a weighted average number of shares in issue during the year of 188,232,913 (2002: 178,119,748). Share options, warrants and the convertible debenture are at present anti-dilutive. 3. Research and development costs relating to continuing operations are stated after an exceptional credit of #nil, (2002: #674,000) arising from the re-instatement of stocks written off in the prior year, following FDA approval of DigiFabTM (the Group's treatment for digoxin poisoning) in August 2001. 4. On 12 July 2001, the Group sold its computer aided molecular design division (CAMD) to Tularik Inc. The sale included the Group's propriety Prometheus software and related computer hardware, together with laboratory equipment. Existing CAMD research agreements also transferred to Tularik under the terms of the agreement. Copies of this statement will be available to the public at the Company's registered office at The Heath Business & Technical Park, Runcorn, Cheshire WA7 4QF. This information is provided by RNS The company news service from the London Stock Exchange END FR KGGGVNFZGFZM
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