Final Results

Oxford Biomedica PLC 27 February 2002 27 February 2002 For further information, please contact: Oxford BioMedica plc Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000 City/Financial Enquiries: Melanie Toyne Sewell / Fiona Noblet Financial Dynamics Tel: +44 (0)20 7831 3113 Scientific/Trade Press Enquiries: Chris Gardner, HCC•De Facto Group Tel: +44 (0)20 7496 3300 OXFORD BIOMEDICA PLC ('BIOMEDICA') PRELIMINARY RESULTS FOR THE YEAR ENDED 31 DECEMBER 2001 • Funding: Successful move from AIM to the main market of the London Stock Exchange in April 2001, with a placing and open offer raising £32.3 million, net of expenses; proceeds being invested to expand clinical and development pipelines, and establish a US subsidiary. • Financial performance: Turnover for the year ended 31 December 2001 was £0.4 million (2000: £0.7 million), loss after tax was £8.4 million (2000: £5.0 million), in line with expectations. • Research & development: Substantial investment in development programmes, with two products in the clinic and seven in preclinical development. • Cash position: Bank balance at 31 December 2001 was £32.6 million (2000: £11.6 million); capital expenditure increased to £3.2 million in 2001 (2000: £0.9 million) due to investment programmes and expansion, but is expected to decrease in 2002. • Clinical: Positive interim data on MetXia(R) and TroVax(R), presented at the Beeson Gregory cancer conference in February 2002. • MetXia(R): Two out of four patients completing the MetXia(R) trial showed reductions in the sizes of tumours that had been injected with MetXia(R). One of these showed a marked improvement of a cancerous lesion that had not been treated directly, suggesting that MetXia(R) not only induces tumour death in directly treated tumours but may also induce an immune response that destroys other tumours in the patient's body. If these observations are sustained in the subsequent BC2 trial the market potential for MetXia(R) will be broader than originally anticipated as the product could be used for the treatment of both primary and secondary tumours. • TroVax(R): Two out of the three immunocompetent patients in the low dose group of the TroVax(R) trial showed clinical improvements. In one patient the TroVax(R)-induced immune response was associated with a period of disease stabilisation and in another it correlated directly with substantial tumour death. Data for the mid-dose and high-dose groups are being accumulated at present and initial results will be released within the next few months. On the basis of these positive results the Group is considering Phase II studies both in the UK and the USA. • Preclinical development: Acceleration of the neurobiology preclinical programme; ProSavin(R), the Parkinson's product, has shown efficacy in preclinical models and is on course to move into clinical development during 2002 with initial discussions with the FDA taking place within the next few months. • Research: First milestone achieved with nerve regeneration programme with King's College, London. Subject to preclinical data and production development, ProCaStat(R), for prostate cancer, is set to proceed through preclinical research and enter clinical development during 2002. ProCaStat(R) may be BioMedica's first LentiVector(R) product to enter clinical trials. • Gene Discovery: First drug targets identified; discussions ongoing with chemistry companies to develop lead compounds for stroke and cardiovascular disease. • External programmes: Extension of programmes with Wyeth and IDM; continuation of collaborations with Aventis, Valentis and Nycomed Amersham; termination of diabetes project with Modex in October via mutual agreement. • Patents: 33 patents were awarded to BioMedica during 2001 including broad patents covering the Group's LentiVector(R) technology; 20 new applications were filed; to date every patent application that has proceeded to examination has been granted. • Board appointments: Raj Uppal as a non-executive director and Dr Doug Jolly as Chief Executive Officer of the US subsidiary, BioMedica Inc. and to the Group Board. Commenting on the Preliminary Results, Dr Peter Johnson, Chairman of Oxford BioMedica, said: '2001 has been a landmark year for BioMedica with its move to the Official List, the establishment of a US operation and early, positive clinical results emerging from our internal development programmes. With the funds raised, we have invested significantly in the Group; we expect to see results from this investment coming through in 2002 with a substantial expansion of the clinical programmes arising from our oncology and neurobiology activities as well as a number of new product opportunities.' -Ends- Notes to Editors 1. Oxford BioMedica plc Established in 1995, the Company specialises in the application of gene-based technology to the development of novel therapeutics. Its three principal activities are in the fields of gene therapy, immunotherapy and genomics, and its principal therapeutic areas are in cancer and neurodegenerative diseases. Oxford BioMedica plc was floated on the Alternative Investment Market of the London Stock Exchange in December 1996, and was promoted to the United Kingdom Listing Authority Official List in April 2001 following a successful £35.5 million fund-raising. Oxford BioMedica is headquartered in Oxford, UK and has operating centres in Oxford and San Diego, USA. Currently Oxford BioMedica has corporate collaborations with Aventis, IDM, Nycomed Amersham, Valentis, Virbac and Wyeth. BioMedica has two products in Phase I/II clinical trials: MetXia(R) for late-stage breast cancer, and TroVax (R) for late-stage colorectal cancer. 2. World Wide Web This release is also available on the World Wide Web at: http:// www.oxfordbiomedica.co.uk Chairman and Chief Executive's Report In gaining admission to the Official List of the United Kingdom Listing Authority and to trading by the London Stock Exchange in April 2001, Oxford BioMedica achieved a major goal. The Company also raised £35.5 million before expenses in a placing and open offer that was supported by major institutions in London and Europe - a substantial accomplishment in difficult financial markets. This success was a direct result of the Group's technical, clinical and commercial progress since its foundation in 1996. The fundraising and move to the Official List resulted in many existing shareholders reinvesting, and it also brought more than 15 new institutions onto the shareholder register. As a result, the breadth of BioMedica's institutional investor base has expanded. The money raised has enabled the Group to expand its clinical programmes, to continue its aggressive research and development programme, to increase its facilities in Oxford and to establish a wholly owned subsidiary, BioMedica Inc. in San Diego, California. BioMedica Inc. will develop new production technologies for the Group's products, run much of the neurobiology research and development, and act as a focal point for interactions with the FDA as BioMedica moves towards conducting clinical trials in the USA. The subsidiary will also function as an important centre for business development in the USA and, in that role, new opportunities are already being created. Clinical Development Beyond the move to the Official List, some of BioMedica's most important recent events have been in the clinical development programmes. In July 2001, the Gene Therapy Advisory Committee gave BioMedica approval for a 'new' version of MetXia(R) to be used in the Phase I/II MetXia(R) clinical trial. The rapidity of approval was testament to the quality of the safety and gene transfer data obtained in the first part of the MetXia(R) BC1 trial. At the Beeson Gregory Cancer conference in February 2002, BioMedica presented encouraging results from the first part of the BC1 trial. In Phase I/II cancer trials it is common for patients to drop out of the trial because of the severity of their disease. However, of the four patients who did complete the trial, two showed clear reduction in the size of their treated tumours. In addition, one of the patients showed a clear improvement in a cancerous skin lesion that had not been treated directly. This suggests the involvement of a systemic anti-tumour immune response that might be exploited to clear secondary tumours and thereby broaden the market for MetXia(R). BioMedica also presented interim results from the TroVax(R) trial, where there was also evidence of clinical improvement. Tumour destruction was correlated with an immune response induced by TroVax(R) in two out of three immunocompetent patients. These interim data are exciting and provide a useful basis for future trials. However, because of the small size of the trial group and the varying stages of disease amongst the patients, further analysis will be required before firm conclusions can be made about the efficacy of MetXia(R) and TroVax(R). Together with the safety, gene transfer and immunological data, these initial results support the continuing investment in MetXia(R) and TroVax(R). This includes the alternative formulations of MetXia(R) and TroVax(R), MetXia(R)-MG and MetXia(R)-VM and TroVax(R)-DC. The development pipeline is strong with several new clinical programmes due to start this year (see Figure 1). Product Portfolio (Figure 1) Product Resource Research Preclinical Phase I/II MetXia(R) (Cancer) BioMedica Phase I/II MetXia(R)-MG (Cancer) BioMedica/IDM Preclinical MetXia(R)-VM (Cancer) BioMedica/Valentis Preclinical TroVax(R) (Cancer) BioMedica Phase I/II TroVax(R)-DC (Cancer) BioMedica/IDM Preclinical TroVax(R)-Vet (Vet cancer) Virbac Research OBA1 Immunotoxin (Cancer) AHP/Wyeth Research OBA1 Imaging (Cancer) Amersham Research BetOvac(R) (Ovarian cancer) BioMedica Preclinical ProCaStat(R) (Prostate cancer) BioMedica Preclinical ProSavin(R) (Parkinson's) BioMedica Preclinical RenurexTM (Nerve repair) BioMedica Research Neovascularisation (Cardio) Aventis Research ImmStat(R) (HIV infection) BioMedica (on hold) Preclinical Preclinical Research Progress has been made on all fronts, but the preclinical highlight of the year has been in neurobiology. At the time of the April 2001 fundraising, BioMedica stated that some of the money raised would be used to accelerate development of the Group's neurobiology products. In the Parkinson's disease programme, ProSavin(R) was shown to correct the symptoms in a preclinical model of the disease, putting the candidate product on course for clinical development in 2002. In addition, BetOvac(R) has shown good efficacy in preclinical models of ovarian cancer, and the hypoxia response element that brings genes under the control of oxygen concentration was used in the successful development of a candidate for treating anaemia. Research The Group's research ranges from small exploratory activities to major projects aimed at establishing novel product development programmes. In the nerve regeneration programme with King's College, London, the first major milestone in the collaboration was achieved. Progress to date with this collaboration has been rapid, and this bodes well for the future of this innovative approach to nerve repair for spinal injury and diabetic neuropathy. The programme has now entered the preclinical phase. Other important developments were the demonstration that the hypoxia response element can be used to control the treatment of retinopathies, the most common cause of blindness, and the configuration of a lentiviral vector-based candidate product for prostate cancer, ProCaStat(R). Subject to obtaining preclinical efficacy data and the development of a clinically useful vector production process, ProCaStat(R) is a candidate for the first LentiVector(R) product that the Group will take to the clinic. Gene Discovery Division BioMedica's genomics activity is now fully staffed and housed in new facilities on the Oxford Science Park alongside the laboratories that are used for therapeutic product development. The initial programme has already generated potential targets for stroke, angiogenesis and inflammation. New programmes in neurobiology are gaining pace with further work being done in stroke and nerve regeneration. Coincident with BioMedica's move into focused genomics has been a general change in the market, with a greater emphasis on downstream products. The directors believe that BioMedica is well placed to respond to this change, and the Group has already taken steps to move its focus from target identification to product lead generation, both for new biological and new chemical entities. BioMedica is in discussion with small molecule development companies to generate candidate drugs for novel targets in order to leverage the value of its discovery programme. External Programmes The major commercial event of the year was the deal with Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corporation ('Wyeth') for the development and commercialisation of a novel anti-cancer therapy based on an Oxford BioMedica proprietary antibody. This collaboration is progressing well, with the second payment having been received in February 2002 from Wyeth for the continuation of the programme. This programme has also laid the foundations for building a future capability in antibody technology. In the collaboration with IDM S.A., the goal of defining new clinical programmes during 2001 was achieved, and this should result in new clinical trials starting in 2003. The Aventis cardiovascular programme has been delayed by the transfer of the Aventis gene therapy activities to Gencell. However, the interaction remains in place. All of the Group's other collaborations are progressing, with the exception of the diabetes project with Modex, which was terminated by mutual agreement in October 2001, due to Modex changing its business plan. BioMedica's LentiVector (R) technology worked well and was able to deliver genes to the insulin-producing b-islet cells at high efficiencies. As a result, the Group anticipates that the Modex programme will be replaced by another diabetes collaboration in due course. Intellectual Property More than a quarter of BioMedica's patent portfolio has now been examined in the major territories of Europe, USA and Japan. So far, every application that has proceeded to examination has led to an issued patent. 2001 was a particularly good year with 33 patents being granted including broad patents for LentiVector (R) and other aspects of gene delivery and regulation. In addition, 20 new applications were filed during 2001, protecting the growing output from the Gene Discovery Division and enhancing the protection of the product development programmes in immunotherapy and neurobiology. The Group will continue to pursue an aggressive patent strategy to build a portfolio that constitutes the foundations of shareholder value. Commercial Strategy The overall strategy continues to be the management of risk, inherent in pharmaceutical product development, by creating as many commercial opportunities as possible. Any one of the product opportunities that the Group has created so far could make BioMedica profitable if it reached the market. However, this must be achieved within a controlled budget. This approach has been successful so far, with the Group funding internal product development in cancer and neurobiology, and partners funding and carrying out the majority of the other collaborative programmes. This dual approach will continue, but as the Group's clinical trials progress, there will be a greater emphasis on establishing partnerships for internal product programmes. This will begin in 2002. However, there is always a balance to be struck between an early deal and investing further in the product to increase its value. The intriguing but anecdotal clinical benefits to patients in the MetXia(R) and TroVax(R) trials make this judgement of fundamental importance for mid-term shareholder value. The events of September 11th and the economic downturn of last year led many companies to retrench. This slowed progress on several potential new collaborations. Nevertheless, there remains considerable interest in the Group's technology and candidate products from both biotech and pharmaceutical companies. Financial The placing and open offer has significantly strengthened the balance sheet, and has allowed the planned increase in operations, including the programmes described above. The average headcount increased in 2001 by 49% from 49 to 73, and the Oxford offices and laboratories were expanded from 11,000 sq.ft. to 28,000 sq.ft. BioMedica Inc. was incorporated in February 2001 and began operations in the second half of 2001. The 2001 financial result was in line with the budget that was set at the time of the placing and open offer. Operating expenses in 2001 were £11.4 million, an increase of 69% over 2000 as a result of increased levels of activity. This was offset by higher interest receivable on bank deposits and a three-fold increase in the UK Corporation Tax research and development credit. The loss after tax for 2001 was £8.4 million (2000 loss: £5.0 million). Capital expenditure in 2001 was £3.2 million, of which £2.4 million was for the fitting out and equipping of new laboratories and offices in Oxford, and £0.5 million was for equipment at BioMedica Inc. The bank balance at 31 December 2001 of £32.6 million (2000: £11.6 million) was in line with the budget. The net cash outflow was £11.9 million (2000: £5.6 million). Changes to the Board During the year BioMedica made two key appointments. In February 2001 the Group welcomed Mr Raj Uppal to the board as a non-executive director. Raj is a Chartered Accountant and has extensive financial and commercial experience in the sector. He is currently a Senior Vice President of the drug delivery business unit of Elan Corporation. In May 2001 Dr Doug Jolly was appointed CEO of the Group's US subsidiary BioMedica Inc., and to the Group board. Dr Jolly is a leading figure in gene technology in the USA. He is a named inventor on many patents, and was founder and Vice-President of Research of Viagene Inc. Most recently he held the position of Vice President for Scientific Affairs at Chiron Corporation's Center for Gene Therapy. In Summary 2001 has been a landmark year for BioMedica with its move to the Official List, the establishment of a US operation and the greater emphasis on clinical results emerging from its internal programmes. As a result of the funds raised in 2001, the Group has been able to make substantial increases in the level of investment in research and development and in facilities and equipment, in order to expand its development and clinical pipelines and so to build up the base from which future shareholder value will be derived. Looking forward, the focus for 2002 is to extend the clinical and preclinical pipeline further. In particular, we expect to complete the Phase I/II trials for MetXia(R) and initiate Phase II clinical trial programmes with TroVax(R). We thank our shareholders and our dedicated, hard-working staff for their significant support during 2001 and we look forward to further success during 2002. Dr Peter Johnson Chairman Prof. Alan Kingsman Chief Executive Officer Consolidated profit and loss account for the year ended 31 December 2001 2001 2000 Notes £'000 £'000 Turnover 2 373 732 Research and development costs (8,570) (5,033) Administrative expenses (2,859) (1,731) Operating expenses (11,429) (6,764) Other operating income: government grants receivable 29 96 Net operating expenses (11,400) (6,668) Operating loss (11,027) (5,936) Interest receivable 1,486 541 Loss on ordinary activities before taxation 2 (9,541) (5,395) Tax credit on loss on ordinary activities 3 1,152 393 Loss for the year (8,389) (5,002) Basic loss and diluted loss per ordinary share 4 (3.8p) (3.1p) The results for the years above are derived entirely from continuing operations. There is no difference between the loss on ordinary activities before taxation and the loss for the years stated above, and their historical cost equivalents. Statement of group total recognised gains and losses 2001 2000 Notes £'000 £'000 Loss for the financial year (8,389) (5,002) Currency translation differences on foreign currency net 8 (2) - investments Total recognised losses for the year (8,391) (5,002) Consolidated balance sheet at 31 December 2001 2001 2000 Notes £'000 £'000 Fixed assets Intangible assets 234 283 Tangible assets 5 3,647 1,304 Investments 26 26 3,907 1,613 Current assets Debtors 6 2,712 1,069 Cash at bank and in hand 32,645 11,635 35,357 12,704 Creditors: amounts falling due within one year 7 (1,756) (1,340) Net current assets 33,601 11,364 Net assets 37,508 12,977 Capital and reserves Called-up share capital 2,382 1,721 Share premium account 58,689 26,428 Other reserve 711 711 Profit and loss account (deficit) (24,274) (15,883) Equity shareholders' funds 8 37,508 12,977 Consolidated cash flow statement for the year ended 31 December 2001 2001 2000 £'000 £'000 Operating activities Net cash outflow from continuing operating activities (reconciliation to operating loss below) (9,846) (5,306) Returns on investments and servicing of finance Interest received 1,120 407 Taxation Overseas tax paid (2) - Capital expenditure Purchase of tangible fixed assets (3,182) (683) Net cash outflow before management of liquid resources and financing (11,910) (5,582) Management of liquid resources Transfer to deposit accounts (32,190) (14,729) Transfer to current accounts 10,886 3,637 (21,304) (11,092) Financing Issue of ordinary shares 36,108 14,603 Expenses of share issue (3,186) (425) Net cash inflow from financing 32,922 14,178 Decrease in cash in the year (292) (2,496) Reconciliation of operating loss to net cash outflow from operating activities 2001 2000 £'000 £'000 Continuing activities Operating loss (11,027) (5,936) Amortisation of intangible fixed assets 49 49 Depreciation of tangible fixed assets 840 321 Loss on disposal of fixed assets 1 5 Decrease in debtors due after more than one year 37 - Increase in trade debtors - 24 Decrease/(increase) in other debtors and other tax receivable 16 (52) Increase in prepayments and accrued income (163) (82) Increase in trade creditors 216 99 Increase in other taxation and social security 58 57 Increase in accruals and deferred income 127 209 Net cash outflow from continuing operating activities (9,846) (5,306) Notes to accounts 1 Basis of preparation The preliminary results for the year ended 31 December 2001 do not constitute the Company's statutory financial statements within the meaning of s227 of the Companies Act 1985, but are derived from the audited statutory financial statements. The financial information for the year ended 31 December 2000 is derived from the statutory accounts for that year which have been delivered to the Registrar of Companies. The auditor's reports on these accounts were unqualified. The new accounting standard FRS 18 (Accounting policies) has been adopted in the current year. This has not resulted in any changes in accounting policies. Copies of this announcement are available from the Company Secretary. The audited statutory financial statements for the year ended 31 December 2001 are expected to be distributed to shareholders by 15 March 2002 and will be available at the registered office of the Company, Medawar Centre, Oxford Science Park, Oxford, OX4 4GA. This announcement was approved by the Board of Oxford BioMedica plc on 26 February 2002. 2 Turnover and loss on ordinary activities before taxation The Group's turnover and loss on ordinary activities before taxation are derived entirely from its principal activity. With the commencement of operations of BioMedica Inc., the Group now has operations in the United Kingdom and in the United States of America. 2001 2000 Turnover Turnover by Turnover by Turnover by Turnover by destination origin destination origin Geographical analysis £'000 £'000 £'000 £'000 United Kingdom 67 373 283 732 Rest of Europe 35 - 85 - North America 271 - 364 - 373 373 732 732 Loss on ordinary activities before taxation 2001 2000 Geographical analysis £'000 £'000 United Kingdom 8,770 5,395 North America 771 - 9,541 5,395 Net assets 2001 2000 Geographical analysis £'000 £'000 United Kingdom 4,352 1,342 North America 511 - Net operating assets 4,863 1,342 Cash at bank and in hand 32,645 11,635 37,508 12,977 3 Tax credit on loss on ordinary activities The Group is entitled to claim tax credits for certain research and development expenditure. The amount included in the financial statements for the year ended 31 December 2001 represents the credit receivable by the Group for that year, less income tax payable by the Group's subsidiary in the United States of America. These amounts have not yet been agreed with the relevant tax authorities. 2001 2000 £'000 £'000 United Kingdom Corporation Tax research and development credit 1,167 393 Overseas taxation (15) - 1,152 393 4 Basic loss and diluted loss per ordinary share The basic loss per share has been calculated by dividing the loss for the year by the weighted average number of shares of 219,196,867 in issue during the year ended 31 December 2001 (2000: 161,851,789). The Company had no dilutive potential ordinary shares in either year which would serve to increase the loss per ordinary share. There is therefore no difference between the loss per ordinary share and the diluted loss per ordinary share. 5 Tangible fixed assets Short Leasehold Office improvements equipment, Computer Laboratory fixtures and equipment equipment Total fittings £'000 £'000 £'000 £'000 £'000 Cost At 1 January 2001 460 109 708 1,051 2,328 Additions 1,414 103 259 1,408 3,184 Disposals - (1) (46) - (47) At 31 December 2001 1,874 211 921 2,459 5,465 Depreciation At 1 January 2001 330 69 75 550 1,024 Charge for the year 211 29 258 342 840 Eliminated on disposals - (1) (45) - (46) At 31 December 2001 541 97 288 892 1,818 Net book amount at 31 December 2001 1,333 114 633 1,567 3,647 Net book amount at 31 December 2000 130 40 633 501 1,304 6 Debtors 2001 2000 £'000 £'000 Amounts falling due after more than one year Other debtors - rent deposit - 37 Amounts falling due within one year Other debtors 531 279 Corporation tax receivable 1,560 393 Other tax receivable 193 95 Prepayments and accrued income 428 265 2,712 1,032 Total debtors 2,712 1,069 7 Creditors: amounts falling due within one year 2001 2000 £'000 £'000 Trade creditors 638 430 Overseas taxation 13 - Other taxation and social security 181 123 Accruals and deferred income 924 787 1,756 1,340 8 Reconciliation of movements in Group shareholders' funds 2001 2000 £'000 £'000 Loss for the year (8,389) (5,002) New share capital issued 36,108 14,603 Expenses of share issue (3,186) (425) Exchange differences (2) Net addition to shareholders' funds 24,531 9,176 Opening shareholders' funds 12,977 3,801 Closing shareholders' funds 37,508 12,977 This information is provided by RNS The company news service from the London Stock Exchange
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