Final Results

Phytopharm PLC 05 December 2002 5 December 2002 Preliminary results for the year ended 31 August 2002 Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm or the 'Group') today announces its preliminary results for the year ended 31 August 2002. Period highlights - Future development programme agreed with Pfizer on obesity and metabolic syndrome (P57) - Opening of a new botanical supplies unit in South Africa to expand manufacturing capacity (P57) - Phytopharm's own novel synthetic programme for obesity initiated (P64) - Successful completion of 28 day Phase I repeat dose study in age-related cognitive impairment (P58) - Evidence of neuroprotective effect in pre-clinical models of Parkinson's disease (P63) - Survival benefit demonstrated in pre-clinical models of motor neurone disease (P59) - Completion of Phase II study in inflammatory bowel disease (P54) - Commencement of European multi-centre study in canine atopic dermatitis (P7v) Dr Richard Dixey, Chief Executive of Phytopharm, said: 'Phytopharm's focus on its four key platforms has allowed the Group to generate strong intellectual property and to move into related disease processes with new chemical forms. In addition to the eight products we had in development at the beginning of the year, two further projects have entered full development during 2002. We continue to generate strong product progress within tightly controlled operational costs and are on target to meet all our deliverables during 2003.' Enquiries: Phytopharm plc Today: 07867 782000 Dr Richard Dixey, Chief Executive Thereafter: 01480 437697 Mobile: 07867 782000 Financial Dynamics Tel: 0207 831 3113 David Yates / Ben Atwell Phytopharm has updated its website from 5 December 2002; www.phytopharm.co.uk Business Model Phytopharm develops a portfolio of products that have emerged from a well-established research base. Its expertise in manufacturing controlled plant extracts (botanicals) enables it to initiate early clinical evaluations and base substantial research platforms on the emergent clinical data. These platforms are not only novel, but allow the Group to generate strong intellectual property and to move into related disease processes with new chemical forms. Phytopharm invests shareholders' funds in developing its portfolio, and remains a well-funded Group with over two years working capital at current burn rates. Once product development programmes have reached a substantive stage, the Group seeks pharmaceutical partners who pay for options to market products based on intellectual property owned by Phytopharm. These option agreements involve substantial payments to the Group, comprising the reimbursement of further development costs, the payment of milestones as key phases are completed, and royalties on eventual product sales. These payments are negotiated by reference to the size of the eventual market, the stage of development of the product concerned and the strength of the data generated. With its small central overhead, Phytopharm offers the potential of sustained profitability once its main products have been licensed in this manner, even if royalty income arising from sales of such products is some years off. Furthermore, the botanical approach also enables the parallel development of products for early marketing in the companion animal market, thereby balancing early revenue generators with major pharmaceutical products. Operational Review The metabolic disorders platform is focussed on obesity, obese onset diabetes and metabolic syndrome. Licensed to Pfizer Inc in 1998, the P57 platform comprises the patented use of three plant species, their mode of action and 17 related active molecules. In March 2002, Phytopharm announced the opening of a new botanical supplies unit in South Africa to substantially expand the manufacturing capacity for P57 in support of the further development of the product. The new facility expands the capacity for processing the raw materials by 300 per cent and a programme to process substantial quantities of plant material has been successfully undertaken. In July 2002, Phytopharm announced the future development programme with Pfizer. The agreement followed the successful demonstration of proof of principle in man that was announced in December 2001. Pfizer will now progress the P57 development programme concerning extracts of medicinal plants under the ongoing terms of the Licence and Royalty Agreement announced between Pfizer and Phytopharm in 1998. This programme is intended to result in the development of a botanical prescription pharmaceutical for the treatment of obesity and metabolic syndrome. Phytopharm has now developed screens that are predictive of appetite suppressant activity. This has enabled the development of synthetic molecules that will form the basis of a further licensing opportunity. This programme (P64) is intended to result in the development of a pharmaceutical prescription product for the treatment of obesity and metabolic syndrome. The neurodegeneration platform has been extended to include Alzheimer's, Parkinson's and motor neurone disease. Phytopharm has now developed a total of nine patent families to protect the large group of related chemical compounds within this platform that share this activity. These molecules are actively neuroprotective and stimulate the release of neuronal growth factors. Several lines of research are now progressing in parallel, indicating that these molecules actively reverse the neurodegenerative process. This novel mode of action has established a platform for the development of a number of potentially important therapeutic approaches to diseases including those associated with ageing, such as memory impairment and dementia. This work has enabled Phytopharm to develop a series of screening models that mimic these important observations, and has guided the development of semi-synthetic analogues of the original plant based materials. A series of preclinical toxicology studies has now been completed on a compound arising from the P58 programme, for age-related cognitive impairment, including memory loss, dementia and Alzheimer's disease. In April 2002 Phytopharm announced the completion of a 7-day clinical programme of repeat dosing in the elderly. The successful completion of the final stage of a 28-day repeat dose clinical study was announced in October 2002. The results indicated that the product was well tolerated with a good emergent safety profile. A battery of 10 computerised cognitive function tests was also performed on days 1, 14 and 28 to optimise the cognitive endpoints for further clinical studies. These data have been evaluated for subject variability and consistency and have led to a study design, which centres on verbal memory performance including delayed word recall and overall quality of memory. These parameters will be the focus of the cognitive assessments to be conducted in the forthcoming phase II clinical study in 2003. Manufacture of a compound from the programme for Parkinson's disease (P63) has been successfully completed to GMP in multi-kilogram quantities. This product is planned to enter the clinical phase in Q1 2003. Pre-clinical work has demonstrated that P63 is a potent protective agent against neurodegeneration in vitro and stimulates the release of neurotrophic factors, which have been shown to reverse Parkinson's disease. Furthermore, we have shown that P63 derived products reverse the loss of dopamine receptors in the brain and have powerful neuroprotective effects in models of Parkinson's disease in vivo. The programme for motor neurone disease (P59) has progressed well. Pre-clinical work has demonstrated that P59 improves survival to a greater extent than standard treatment in Progressive Motor Neuropathy (pmn) mice, a model of motor neurone disease (amyotrophic lateral sclerosis; ALS). The inflammation platform consists of a patented combination of two medicinal plants (P54), and includes a family of novel, third generation non steroidal anti-inflammatory drugs ('NSAID') characterised by their inhibition of a wide range of enzymes central to chronic inflammation (P61). In August 2002 Phytopharm announced the results of a Phase IIa study investigating the safety and efficacy of the oral product, P54, in inflammatory bowel disease. The study was conducted at Addenbrooke's Hospital, Cambridge, UK and utilised a double-blind placebo-controlled design. All twenty-seven patients had clinically stable disease, but were dependent on chronic treatment with oral prednisolone (5 - 30 mg / day). Faecal calprotectin (a biomarker of disease activity released by inflammatory cells into the bowel) was determined in each subject at the start of the study. For patients with a baseline calprotectin level below 450 milligrammes per litre, all the patients in the P54 group were able to withdraw from steroid therapy. By contrast, in the placebo group less than half of the patients in this category were able to discontinue steroids without relapse. The study indicated that the P54 product, which is derived from the turmeric family, may play a role in reducing steroid dependency in patients with less severe forms of bowel disease. Treatment with P54 was generally very well tolerated and there were no safety concerns that caused any changes of dosing regimen. There is also potential for the use of compounds that reduce the expression of inflammatory enzymes in the companion animal market. The results last year of our double-blind placebo controlled trial using P54v in canine osteoarthritis have enabled the Group to actively pursue commercialisation of P54v in the veterinary market. Large-scale manufacture of P54 is currently ongoing with a view to commercialisation. Research into the mode of action of this platform has continued to generate novel synthetic molecules. Pre-clinical work has demonstrated that these molecules have powerful anti-inflammatory and antispasmodic effects. This programme is intended to result in a pharmaceutical prescription medicine for the treatment of inflammatory disorders and irritable bowel syndrome. The lead candidate, P61, will enter development in the second half of 2003. Finally, the dermatology platform comprises the patented use of five plants with a novel mode of action for the treatment of eczema. These products have a dual mode of action that targets both the allergic and the inflammatory components of eczema. In March 2002 Phytopharm announced the commencement of a European multi-centre study in canine atopic dermatitis with P7v, a three plant botanical product. This randomised, double blind, placebo controlled study is being conducted by specialist veterinary dermatologists and will determine the optimal dose for future commercialisation of the product. In total, one hundred and twenty dogs with perennial atopic dermatitis are being randomly allocated to one of four dose groups. The owners add the appropriate dose of either P7v or the matching placebo product to their dogs' food once daily for 12 weeks. The response to dosing will be assessed by changes in the canine atopic dermatitis extent and severity index (CADESI), severity of pruritus, the incidence of secondary skin infection and the overall response reported by both the veterinarians and dog owners. The study is expected to report in Q4 2003. Over the period Phytopharm completed the pharmaceutical development of the product and is now able to manufacture tonne quantities of material to GMP standards. Discussions with potential partners are now advancing with regard to the further development and commercialisation of this product. Methods to develop a scalable version of the active compound emerging from this programme, coded P55, are being developed for use in the treatment of dermatitis and eczema in humans. Licensing progress Discussions under confidentiality agreements are in progress on products from all four platforms owned and developed by Phytopharm. Such discussions can be lengthy, and involve substantial due diligence and assessment on the part of potential licensees. Nonetheless, significant progress is being made on the neurodegeneration platform (P58) and the opportunity presented by the new chemical forms within the obesity platform (P64) is also generating substantial interest. With Pfizer's stated intention to progress the P57 product and commercial quantities of both veterinary products (P54v and P7v) becoming available during 2003, Phytopharm looks forward to the coming year with confidence. Financial Review Results of operations Turnover of £2.7m for the year (2001: £1.5m) comprises development income under the licence and development agreement with Pfizer Inc for P57, the Group's appetite suppressant. The turnover is higher this year as it includes reimbursement of the 'proof of concept' clinical study completed at the end of 2001 and further manufacturing and other work to prepare for the next clinical study. Overall operating expenses for the year of £7.03m are £2.02m higher than the previous year, an increase of 40%. Within those totals expenditure on research and development rose by 49% (£1.97m) to £6m, with administration costs also increasing by 5% to £1.02m. The increase in research and development expenditure is due to increased expenditure across the Group's portfolio of products, particularly the P58 platform and P7v with the completion of the multistage Phase I clinical study in P58 and the commencement of the multicentre clinical study in P7v. Expenditure on P57 also increased this year with the completion of the clinical study as noted above. Interest income during the year of £0.48m is lower this year (2001: £0.67m) due to a combination of lower average cash balances during the current year and lower interest rates. The tax credit of £0.55m (2001: £0.22m) arose as the Group has taken advantage of the Research and Development corporation tax credits introduced in the Finance Act 2000 whereby the Group may surrender corporation tax losses incurred on research and development expenditure for a corporation tax refund. The increase in the tax credit is due in part to the higher levels of research and development expenditure this year compared to last and because the tax credit was limited to seven months research and development expenditure in the previous year. The increase in turnover of £1.24m and the increase in the tax credit this year of £0.33m have partially offset the increase in research and development expenditure of £1.97m to give a net increase in the loss for the year of £0.63m or 24% to £3.29m. Overall the results for the year were as anticipated and were within budget. Balance sheet The net assets at the end of the year of £10.29m show a reduction of £2.81m over the figure at the start of the year. This represents the loss for the year of £3.29m offset by £0.48m arising from the exercise of share options. The net asset level at the year-end was in line with expectations. The working capital of the Group comprises 98% (2001: 98%) of the net asset value and the bulk of this is held as cash, either on hand or on term deposits. The fixed asset base of the Group remains low at £0.24m (2001: £0.25m) as the Group contracts out its research requirements and therefore does not need to finance its own laboratory facilities. Debtors of £2.84m (2001: £0.37m) comprise principally income due under the licence agreement with Pfizer for P57 and the research and development tax credit. As announced on 30th July 2002 Pfizer will now progress the P57 development programme under the terms of the existing milestone and royalty agreement, which includes up to $32m in milestone payments as well as royalties on sales of P57 by Pfizer, and the debtor from Pfizer at the year end completes reimbursement of this stage of the project. There was no income due under the licence agreement for P57 at the end of the previous year as this fell between the regular reimbursement dates. Short-term creditors at the year-end were £1.95m and are 87% higher (£0.91m) than the previous year. Included within this figure is an additional £0.31m of deferred income with the balance comprising higher trade creditors and accruals. The increase in trade creditors and accruals arises due to higher than average monthly expenditure in July and August 2002. Financing Working capital at 31 August 2002 was £10.04m compared to £12.85m at the end of the previous year. Overall, after allowing for the exercise of options during the year, the Group utilised £3.28m of working capital during 2002 (2001: £2.68m). This is equivalent to an average of £273,000 per month (2001: £223,000) during the year. The average expenditure over the second half of the year was £291,000 (2001: £220,000), which represents an increase of £35,000 per month over the first six months of the year. Both the increase in expenditure over the previous year and the increase in the second half of this year were in accordance with the Group's plan and arise principally as the P58 platform matures and moves through Phase I towards Phase II clinical studies which are anticipated to start in 2003. The Group continues to maintain close control over expenditure, particularly the administrative side of the business, while continuing to develop a wide portfolio of products. Consolidated Profit and Loss Account for the year ended 31 August 2002 Notes 2002 2001 Unaudited Audited £'000 £'000 Turnover 2 2,714 1,471 __________ __________ Gross profit 2,714 1,471 Other operating expenses 3 (7,027) (5,006) __________ __________ Operating loss (4,313) (3,535) Interest receivable and similar income 478 666 Interest payable and similar charges (4) (8) __________ __________ Loss on ordinary activities before taxation (3,839) (2,877) __________ __________ Tax on loss on ordinary activities 4 554 224 __________ __________ Loss for the year (3,285) (2,653) ========= ========= Basic fully diluted loss per ordinary share (pence) 5 (8.5) (7.1) IIMR loss per share (pence) 5 (8.4) (7.1) All revenue and expenses shown above were generated from continuing operations. The Group has no recognised gains or losses for the financial year other than those disclosed above. Consolidated Balance Sheet at 31 August 2002 Notes 2002 2001 Unaudited Audited £'000 £'000 Fixed assets Tangible assets 241 247 Investments - 30 __________ __________ 241 277 Current assets Debtors 2,843 369 Cash held on deposit as short term investments 8,831 12,668 Cash at bank and in hand 323 854 __________ __________ 11,997 13,891 Creditors: amounts falling due within one year (1,953) (1,046) __________ __________ Net current assets 10,044 12,845 __________ __________ Total assets less current liabilities 10,285 13,122 __________ __________ Creditors: amounts falling due after more than one year - (14) Provisions for liabilities and charges - (16) __________ __________ Net assets 10,285 13,092 ========= ========= Capital and reserves Called up share capital 386 382 Share premium account 6 31,726 31,252 Merger reserve 6 (204) (204) Profit and loss account 6 (21,623) (18,338) __________ __________ Equity shareholders' funds 10,285 13,092 ========= ========= Consolidated Cash Flow Statement for the year ended 31 August 2002 Notes 2002 2001 Unaudited Audited £'000 £'000 Net cash outflow from continuing operating activities 7 (5,361) (3,273) _________ _________ Returns on investment and servicing of finance Interest received 478 666 Interest paid on finance leases (4) (8) _________ _________ 474 658 _________ _________ Taxation UK corporation tax received 224 - _________ _________ Capital expenditure and financial investment Purchase of fixed asset investments - - Purchase of tangible fixed assets (140) (128) Proceeds on sale of tangible fixed assets 13 13 _________ _________ (127) (115) _________ _________ Cash outflow before use of liquid resources and financing (4,790) (2,730) _________ _________ Management of liquid resources Decrease/(increase) in cash held on short term deposit 3,837 (8,140) Financing Proceeds from exercise of share options 478 183 Proceeds from issue of share capital - 11,030 Expenses of issue of share capital - (229) Repayment of principal under finance leases (56) (52) _________ _________ Net cash inflow from financing 422 10,932 _________ _________ (Decrease)/increase in cash in the year (531) 62 ======== ======== Notes to the preliminary announcement 1. Basis of preparation These financial statements have been prepared in accordance with the accounting policies set out in the annual report of the Group for the year ended 31 August 2001, together with the following: Basis of extraction The figures shown for the year to 31 August 2002 represent unaudited abridged financial statements and have not as yet been delivered to the Registrar of Companies. The comparative figures for the year to 31 August 2001 have been taken from, but do not constitute, the Group's financial statements for that financial year. Those financial statements have been reported on by the Group's auditors and delivered to the Registrar of Companies. The report of the auditors was unqualified and did not contain a statement under s237 (2) or (3) of the Companies Act 1985. 2. Turnover 2002 2001 Unaudited Audited £'000 £'000 By business activity Licensing and development 2,714 1,471 ======= ======= All turnover arose in the United Kingdom. 3. Other operating expenses Other operating expenses comprise: 2002 2001 Unaudited Audited £'000 £'000 Continuing operations Research and development 6,003 4,033 Administrative expenses 1,024 973 _________ _________ 7,027 5,006 ======== ======== 4. Tax on loss on ordinary activities 2002 2001 Unaudited Audited £'000 £'000 United Kingdom Corporation tax credit at 24% 554 224 ======= ======= The Group has taken advantage of the Research and Development corporation tax credits introduced in the Finance Act 2000 whereby the Group may surrender corporation tax losses incurred on research and development expenditure for a corporation tax refund at the rate of 24 pence in the pound. 5. Loss per share The basic undiluted loss per share is based on losses of £3,284,517 (2001: loss of £2,653,147) and ordinary shares of 38,480,633 (2001: 37,609,090), being the weighted average number of shares in issue during the period. The IIMR earnings per share figure excludes gains and losses on disposals of fixed assets during the year. 6. Share premium account and reserves Share Profit premium Merger and loss account Reserve account Unaudited Unaudited Unaudited £'000 £'000 £'000 At 1 September 2001 31,252 (204) (18,338) Premium on issue of shares 474 - - Loss for the year - - (3,285) __________ _________ ___________ At 31 August 2002 31,726 (204) (21,623) ========= ======== ========== 7. Reconciliation of operating loss to net cash outflow from operating activities 2002 2001 Unaudited Audited £'000 £'000 Continuing activities Operating loss (4,313) (3,535) Depreciation on tangible fixed assets 124 132 Profit on disposal of fixed assets 9 (9) (Increase)/decrease in debtors (2,144) (41) Increase/(decrease) in creditors 949 195 Provision for impairment of value in fixed asset investments 30 - (Decrease)/increase in provision for employer's national insurance on share option gains (16) (15) __________ __________ Net cash outflow from continuing activities (5,361) (3,273) ========= ========= This information is provided by RNS The company news service from the London Stock Exchange

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