The Active Biotech Group Final Accounts Report For The 2000 Operating Year

The Active Biotech Group Final Accounts Report For The 2000 Operating Year · SAIK-MS phase I study now also includes MS patients · TTS phase I study completed · GAS-vaccine - high protective effect · Increase in vaccine sales by 26% · Profit/loss after net financial items (before items affecting comparability) MSEK -148.6 -according to forecast (MSEK -150) · Profit/loss after items affecting comparability MSEK -419.3 million (MSEK -62.0) Clinical studies now include MS patients A million people worldwide are affected by multiple sclerosis, a chronic autoimmune disease. The body's own immune defence attacks the myelin sheaths surrounding the nerve fibres in the brain, disrupting or breaking the nerve impulses. The disease has a slow, drawn-out cycle and often occurs in spells with alternating periods of improvement and deterioration. There is currently no treatment to halt MS, although beta interferon injections slow the disease in some patients. Active Biotech has selected a new treatment strategy with its immunomodulators, which also have the advantage of being available in tablet form. At present Active Biotech's substance for the treatment of multiple sclerosis, SAIK-MS, is in phase I of clinical trials. A phase I study normally takes the form of a safety study involving healthy volunteers. The Swedish Medical Products Agency has, however, granted Active Biotech permission to include MS patients as early as in phase I, as the product is already regarded as satisfying the necessary safety requirements. The inclusion of MS patients has now commenced. These trials are expected to be concluded during the current year. At the same time as the development work proceeds according to plan, discussions are being conducted with potential cooperation partners. TTS phase I study completed Non small-cell lung cancer (NSCLC) is one of the most commonly occurring malignant diseases. NSCLC is a disease with one of the highest mortality rates in the western world, currently affecting some half a million people every year. There are no effective methods of treatment. NSCLC is primarily treated today with chemotherapy and surgery. Renal cancer (RCC) affects fewer people than NSCLC, approximately 80,000 annually, however the medical need is extensive as no satisfactory treatment currently exists. Within the TTS (Tumor Targeted Superantigens) project, phase I of the study relating to non small-cell lung cancer and renal cancer has been concluded. The preliminary results look promising and the compilation of the final report is currently under way. Discussions are being conducted with leading cancer clinics in Sweden and internationally with a view to commencing phase II trials. Results from the first clinical trials endorse the company's assessment that TTS represents a unique concept for cancer treatment. Moreover, the obtained results give a good starting-point for further development of the TTS-products towards new indications and applications. Diarrhoea vaccines Diarrhoea diseases cause up to four million deaths a year. Infections caused by cholera or enterotoxin forming E.coli bacteria (ETEC) trigger off a diarrhoea that, in severe cases, can lead to dehydration and death. For tourists and business travellers these do not represent the same threat as the symptoms in these categories generally disappear by themselves after a short while. On the other hand they are highly unpleasant and have an extremely limiting effect upon physical mobility during the days in which the condition is present. Discussions are being conducted with the American Food and Drug Administration (FDA) regarding modification of the target effect ("clinical endpoint") for the ongoing ETEC vaccine phase III study in Guatemala and Mexico, to apply to protection against pronounced diarrhoea disease. As the company previously reported, the product have shown a significant vaccination effect for patient groups with pronounced, ETEC induced, diarrhoea disease. Work is also proceeding with the registration of the products SBL Cholera Vaccine and Dukoral internationally, in cooperation with Aventis Pasteur. Other projects The pre-clinical study of Active Biotech's GAS vaccine against tonsillitis, conducted in cooperation with Vaccine Solutions Pty Ltd. in Australia, has been concluded. The vaccine consists of peptides from the streptococcus bacterium's surface structure, produced by Active Biotech in cooperation with external research groups. One of the peptides in the study has also been formulated by means of what is known as proteosome technology in collaboration with the Canadian vaccine company Intellivax. Results from this study indicate a vaccine with a high protective effect, 85-90%, even when administered intranasally against infection caused by streptococci. The company considers the patent protection as being strong for all the antigens. Discussions are being conducted with regard to extended cooperation with Intellivax and Vaccine Solutions. Planning of the clinical development has commenced and a phase I study can start in the first half of 2002. The sale of the CDT technology (Covalent Display Technology) has been completed. The project has been spun off to a newly-formed company, Isogenica Ltd., in which Active Biotech remains as a minority shareholder with a 20 per cent share. Increase in vaccines sales by 26% The increase in turnover, excluding income for contract research, amounted to 25%. Vaccine sales increased by 26% to MSEK 234.5 (MSEK 184.5). The growth is primarily attributable to continued strong development for SBL Cholera Vaccine and Dukoral, which increased sales by 97% to MSEK 64.4 (MSEK 32.7). Dukoral continues to show a strong sales growth in Sweden and Norway. Sales in Sweden increased by 52% to MSEK 27.0 (MSEK 17.8). In Norway, where the product was launched in 1998, sales increased by 106% to MSEK 6.8 (MSEK 3.3). This positive development is explained by increased market penetration and solid growth in the number of travellers to the risk areas. SBL Cholera Vaccine also shows a strong growth in comparison with the preceding year. Sales increased by 176% to MSEK 28.9 (MSEK 10.5). Sales of agency products within the vaccine sector developed less favourably during the year, falling by 2% to MSEK 58.0 (MSEK 59.0). The decrease is primarily attributable to ongoing supply problems, including those relating to influenza vaccines. Distribution orders showed a 25% sales increase to MSEK 99.5 (MSEK 79.7). Net turnover specified according to activity % of % of sales sales Vaccine sales 2000 1999 % 2000 1999 change Own produced vaccines 76.9 46.8 64% 32.8% 25.5% Dukoral/SBL Cholera 64.4 32.7 97% Vaccine Other products 12.5 14.1 -11% AGENCY PRODUCTS 58.0 59.0 -2% 24.7% 31.8% Distribution orders 99.5 79.7 25% 42.5% 43.0% Total vaccine sales 234.5 185.4 26% 100.0% 100.0% INCOME FROM CONTRACT 40.0 75.0 -47% RESEARCH Other income 5.9 6.9 -15% Total net turnover 280.4 267.3 5% Profit/loss after net financial items MSEK -148.6 (before items affecting comparability) In accordance to the previously reported decision that all research projects will be accounted for as costs on a continuos basis, the year's result has been debited with a one-off write-off of previous years' capitalised research costs relating to the vaccine business. The write-off amounts to MSEK 270.2, and will not influence the group's cash-flow. The operating profit/loss before financial items, amounted to MSEK -509.5 (MSEK -112.3). The negative development is explained by items affecting comparability in 2000 and 1999. The current year's result has been debited with MSEK 270.8, of which a one-off write-off of intangible assets amounts to MSEK 270.2. The 1999 result included one-off income derived from property and site sales, amounting to MSEK 139.6. The result before items affecting comparability was thereby improved by MSEK 13, despite a reduction in income from contract research by MSEK 35, when Active Biotech acquired all the rights to the TTS project from Pharmacia and now finances the further development under its own management. The Group's net profit/loss after net financial items improved strongly, from MSEK 54.7 in 1999 to MSEK 90.0 this year, reflecting profits from the disposal of the shares in Lifco AB, realised profits in the Zenit fund as well as, in general, a good development for the financial investments. The positive profit/loss development for comparable units and extraordinary depreciation, is explained by a strong sales growth, a restrictive cost development and also a strong net result after net financial items. The operating profit/loss after net financial items, but before items affecting comparability, amounted to MSEK -148.6 (MSEK -62.0), in line with the submitted full year forecast of MSEK -150. The profit/loss after depreciation of intangible assets amounted to MSEK -419.3 (MSEK -62.0). Financial position Equity capital amounted to MSEK 645.9. Solvency as at 31 December 2000 amounted to 74.3% (74.0%). Liquid funds and financial investments amount to MSEK 416 (MSEK 545). Dividend The Board does not intend recommending a dividend to be paid to the shareholders for the 2000 operating year. General meeting of shareholders An ordinary general meeting of shareholders will take place on Thursday, 29 March, 2001 at 17.00 at the Scandic Star Hotel, Lund, Sweden. Future publication of information · Complete annual report and accounts available at the beginning of March · Quarterly reports to be published on 9 May, 8 August and 6 November · Final accounts report for the complete year 2001 to be published on 14 February 2002 Lund, 15 February 2001 Active Biotech AB (Publ) Sven Andréasson President & CEO Active Biotech AB is a biotechnics company focusing on research and development of medicines and vaccines. Our expertise lies in the knowledge of the human immune defence system. We have a high-quality project portfolio and financial strength. The most important products and projects are medicines for multiple sclerosis (SAIK) and cancer (TTS), the SBL Cholera Vaccine, and Dukoral and ETEC vaccines against tourist diarrhoea. Active Biotech's turnover was MSEK 280 in 2000. Active Biotech AB Box 724, SE-220 07 Lund, Sweden Tel: +46 (0)46-19 20 00 Fax: +46 (0)46-19 20 50 e-mail info@activebiotech.com ------------------------------------------------------------ This information was brought to you by BIT http://www.bit.se The following files are available for download: http://www.bit.se/bitonline/2001/02/19/20010219BIT01000/bit0002.doc http://www.bit.se/bitonline/2001/02/19/20010219BIT01000/bit0002.pdf