Preliminary Results

Oxford Biomedica PLC 10 March 2008 Simultaneously to the analyst briefing at 10:30am, there will be a live audio web cast of the results presentation. To connect to the web cast facility, please go to http://mediaserve.buchanan.uk.com/webcasts/livegold/lrframes.htm approximately 10 minutes (10:20am) before the start of the briefing. In addition to the web cast there will also be a conference callplease dial +44 (0)20 8609 1435 and use pin number 131567# For Immediate Release 10 MARCH 2008 OXFORD BIOMEDICA PLC PRELIMINARY RESULTS FOR THE YEAR ENDED 31 DECEMBER 2007 Oxford, UK - 10 March 2008: Oxford BioMedica (LSE: OXB), a leading gene therapy company, today announces its preliminary results for the year ended 31 December 2007. Operational highlights: TroVax(R): cancer • Global collaboration with sanofi-aventis • Achieved two milestones under sanofi-aventis agreement • Three successful DSMB reviews of TRIST study in renal cancer • Further Phase II results in renal cancer suggest therapeutic potential ProSavin(R): Parkinson's disease • Initiated Phase I/II trial in Parkinson's disease • Efficacy in ongoing preclinical studies exceeds 27 months Hi-8(R) MEL: melanoma • Phase II follow-up confirms survival advantage in immune responders Other development products • Recruitment progressing in Phase II trial of MetXia(R) in pancreatic cancer • Preclinical results with RetinoStat(R) in wet AMD confirm proof of concept • Preclinical results with StarGen(TM) in Stargardt's disease confirm proof of concept • Initiated EndoAngio-GT anti-cancer programme Technology and corporate • Acquisition of Oxxon Therapeutics • Technology licensing agreement with major US biotech company • Secured rights to therapeutic use of Nobel Prize-winning RNAi technology Financial highlights (audited financial results): • Payments from sanofi-aventis £25.8 million (2006: nil) • Revenue £7.2 million (2006: £0.8 million) • Research & development costs £22.1 million (2006: £19.5 million) • Loss for the year £15.3 million (2006: £17.6 million) • Positive operational cash flow £5.9 million (2006: cash burn £15.9 million) • Net cash1 £38.1 million (31 December 2006: £28.5 million) Commenting on the annual results, Oxford BioMedica's Chief Executive, Professor Alan Kingsman said: '2007 has been a transformational year for Oxford BioMedica with the achievement of our two main corporate objectives: a global alliance with sanofi-aventis for TroVax; and the initiation of a Phase I/II trial with ProSavin in Parkinson's disease. We have ended 2007 with four products in clinical development; support for our lead product from a partner that is a major player in oncology and vaccines; and a strengthened balance sheet. In 2008, we will maintain our focused and financially prudent strategy for growth. Over the next 18 months, key clinical results are expected from trials of both TroVax and ProSavin, which could dramatically enhance the value of these programmes and could support the registration of our first therapeutic product.' 1. Cash, cash equivalents and current financial assets -Ends- For further information, please contact: Oxford BioMedica plc: Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000 JPMorgan Cazenove Limited: James Mitford/ Gina Gibson Tel: +44 (0)20 7588 2828 City/Financial Enquiries: Lisa Baderoon/ Mark Court/ Mary-Jane Johnson Tel: +44 (0)20 7466 5000 Buchanan Communications Scientific/Trade Press Enquiries: Gemma Price/ Holly Griffiths/ Katja Stout Tel: +44 (0)20 7457 2020 College Hill Life Sciences US Enquiries: Thomas Fechtner Tel: (646) 378 2900 The Trout Group LLC Notes to editors 1. Oxford BioMedica Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in cancer immunotherapy and gene-based therapies. The Company was established in 1995, as a spin-out from Oxford University, and is listed on the London Stock Exchange. The Company has a platform of gene delivery technologies, which are based on highly engineered viral systems. Oxford BioMedica also has in-house clinical, regulatory and manufacturing know-how. The lead product candidate is TroVax(R), an immunotherapy for multiple solid cancers, which is licensed to sanofi-aventis for global development and commercialisation. TroVax is in Phase III development. Oxford BioMedica has three other products in clinical development, including ProSavin(R), a novel gene-based treatment for Parkinson's disease, in a Phase I/II trial. The Company is underpinned by over 80 patent families, which represent one of the broadest patent estates in the field. The Company has a staff of approximately 85. Oxford BioMedica has collaborations with sanofi-aventis, Wyeth, Sigma-Aldrich, MolMed and Virxsys. Technology licensees include Biogen Idec, Merck & Co, GlaxoSmithKline and Pfizer. Further information is available at www.oxfordbiomedica.co.uk CHAIRMAN'S STATEMENT 2007 has been a transformational year for Oxford BioMedica with the achievement of our two main corporate objectives. Firstly, the global alliance with sanofi-aventis for TroVax, signed in March 2007, is one of the most valuable licensing agreements for an active cancer immunotherapy and provides both near and long-term value for Oxford BioMedica. TroVax will benefit from sanofi-aventis' substantial development expertise in oncology and vaccines as well as its global commercial infrastructure. Together with sanofi-aventis, we are preparing for commercialisation of TroVax, with the first of three planned Phase III trials progressing well. Secondly, in December 2007, we initiated a Phase I/II trial of ProSavin, which is a potentially revolutionary treatment for Parkinson's disease. This is the first clinical trial of a product that utilises our proprietary LentiVector technology, which is the backbone of multiple product candidates in our pipeline and various licensing deals. The start of this trial is the culmination of over ten years of research at Oxford BioMedica. In summary, we ended 2007 stronger than ever in terms of our development pipeline, and our financial position has also been strengthened following the initial payments from sanofi-aventis. Strategic focus Owing to the current risk-adverse capital markets, we have reassessed our development priorities to ensure that internal efforts are focused on those product candidates that offer the greatest potential value to Oxford BioMedica. The strategic purpose of this review was to ensure that the Company continues to grow and expand, but maintains prudent management of its financial resources. We own some exceptional assets in the field of cancer immunotherapy and gene-based medicines with a deep and robust pipeline of product candidates. The strength of these assets means that we are well positioned to pursue our strategy of partnering certain assets to access additional resources, while investing in the further development of key programmes. As part of our strategy, we have sought to broaden our technology platform creating opportunities both for near-term revenue streams from licensing and also new in-house development programmes. In 2007 we acquired Oxxon Therapeutics, which has brought complementary intellectual property in immunotherapy and a novel vaccine for melanoma in Phase II development. Furthermore, in January 2008, we secured exclusive rights to use Nobel Prize-winning RNA interference (RNAi) technology in therapeutic approaches where the active RNAi molecules are delivered using our LentiVector technology. RNAi represents a new treatment approach based on turning off gene expression (gene silencing). We will continue to evaluate new opportunities that are consistent with our strategy and can accelerate the growth of our business. Our core strategic themes are described in the Strategy section of the Business Review. People Our employees are crucial to the success of Oxford BioMedica and we are committed to the development of a motivated and professional workforce. It is their skill and expertise that has enabled us to achieve our progress to date. In 2007, we expanded our staff count to 82 from 73. We will continue to add to our existing team, as we broaden our activities and move towards the commercialisation of our first product, to ensure that we have the appropriate skill base to address these challenges. On behalf of the entire Board, I would like to thank our staff for their hard work in 2007 and their continued support and commitment. Looking Ahead The fundamentals of the biotechnology industry remain strong, particularly for companies that are developing novel biological therapies for major unmet medical needs. The pharmaceutical industry is under pressure to improve its research and development productivity and many of the major pharmaceutical firms have raised their targets for revenue from in-licensed and biological products within the next few years. Oxford BioMedica aims to be the leading company in the specialised areas of cancer immunotherapy and gene-based medicines. During 2007, the pharmaceutical industry showed increased interest in these fields and made some significant investments, as evidenced by several recent collaborations, including our alliance with sanofi-aventis. Over the next few years, we expect to benefit from further convergence between the pharmaceutical industry and innovative biotechnology companies. In 2008, as TroVax moves towards commercialisation and data emerge from the Phase I/II trial of ProSavin, we will maintain our focused and financially prudent strategy for growth. Dr Peter Johnson CHAIRMAN STRATEGY Our goal is to create a profitable biopharmaceutical company through the commercialisation of novel safe and effective gene-based medicines to treat unmet medical needs. To mitigate the inherent risks of drug development, we have adopted a hybrid business model that combines in-house and collaborative research and development, enabling us to establish a portfolio of product candidates that address multiple therapeutic areas. We also actively out-license our proprietary technologies for use in research or drug development to generate near-term revenue streams and, in some cases, royalties on product sales. In 2007, we undertook a review of our pipeline to prioritise our development efforts and maximise the potential return from our in-house investment. With rigorous financial management, we aim to deliver sustained growth and value for our shareholders and other stakeholders. OPERATIONAL REVIEW ADVANCED CANDIDATES TROVAX(R) Development of our lead product candidate, TroVax, is progressing in multiple cancer types. The product is one of the most advanced therapeutic cancer vaccines in development. Therapeutic vaccines have the potential to play a significant role in cancer therapy as additive treatment options for patients. We believe that TroVax could be one of the first registered products in this field. Sanofi-aventis Collaboration In March 2007, we secured a licensing agreement with sanofi-aventis for the global development and commercialisation of TroVax. The agreement is one of the largest alliances in the field of cancer immunotherapy. Oxford BioMedica received payments from sanofi-aventis totalling €38 million in 2007, comprising an initial payment of €29 million and an early development milestone payment of €9 million. A further milestone payment of €10 million was triggered in February 2008 following the third successful interim analysis of the TRIST study by the Data Safety Monitoring Board. Further development and regulatory milestone payments could yield up to €470 million if TroVax is approved for a small number of defined cancer types. Oxford BioMedica is entitled to additional milestone payments for other cancer types, commercial milestone payments when sales reach certain targets and tiered escalating royalty income on global sales. The Phase III TRIST study of TroVax in renal cancer is being managed by Oxford BioMedica and co-funded with sanofi-aventis. All other TroVax activities, including development, registration and commercialisation, will be funded by sanofi-aventis. As part of the agreement, sanofi-aventis is committed to the rapid initiation of a Phase III trial in colorectal cancer. In terms of commercialisation, Oxford BioMedica retains an option to participate in the promotion of TroVax in the USA and the European Union. Phase III TRIST Study Progress The Phase III TRIST (TroVax Renal Immunotherapy Survival Trial) study is progressing well. We are approaching full recruitment of 700 patients. The rate of recruitment has been encouraging. Over 100 centres are participating in the USA, Western Europe and Eastern Europe. It is rare for such a large trial to recruit to plan. One factor that affects the rate of recruitment, but is difficult to predict at the outset of a multi-centre trial, is clinicians' enthusiasm for the product. Clinicians have been highly supportive of the trial, which reflects TroVax's excellent safety profile and potential to improve patients' survival and quality of life. The trial has been recruiting at a rate of about 50 patients per month. This is comparable to the recruitment rate for the Phase III trial of Pfizer's Sutent(R) (sunitinib), which was one of the recently launched targeted agents for renal cancer that has had rapid uptake in terms of commercial sales. In January 2007, the UK National Cancer Research Network (NCRN), which provides the UK National Health Service (NHS) with the infrastructure to support cancer clinical trials, agreed to adopt the trial. The NCRN's adoption of TRIST means that multiple NHS centres are participating in the study. In reaching its decision to adopt the TRIST trial, the Renal Cancer Clinical Studies Group of the NCRN evaluated TroVax and the trial design and concluded that the product offers potential improvement in care for patients within the NHS. The study is being conducted in patients with locally advanced or metastatic clear cell renal carcinoma. It is a randomised, placebo-controlled, two-arm study comparing TroVax in combination with standard of care to placebo with standard of care. The standard of care therapy can be sunitinib, interferon-alpha or interleukin-2. The protocol stratifies treatment between the three standards of care to ensure that the allocation of TroVax and placebo is rigorously balanced. The primary endpoint for the trial is overall survival; secondary endpoints include the percent of patients with progression-free survival at week 26, tumour response rates and quality-of-life scores. The trial is being conducted under a Special Protocol Assessment (SPA) agreement from the FDA. The SPA specifies the design, conduct, analysis and endpoints of the trial. With this in place, this single comparative trial may be used to support an efficacy claim in a regulatory submission to the FDA. The independent DSMB for the TRIST study has completed three scheduled interim analyses, the most recent one being in February 2008. Following each review, the DSMB concluded that the trial should continue as planned without modification. The role of the DSMB is to evaluate unblinded data from the ongoing trial to determine whether there are safety or efficacy issues that would warrant modification of the protocol or early termination of the study. The DSMB is independent of Oxford BioMedica and sanofi-aventis. To preserve the study blinding, the DSMB provides no additional information other than its recommendation. Based on the current progress, we expect the trial to reach its primary endpoint in the first half of 2009, which is aligned with our expectations at the outset of the study. If the primary endpoint is achieved, sanofi-aventis could file its first regulatory submission for registration of TroVax in renal cancer within a few months of the trial results. With Priority Review from the FDA, the regulatory review period could be six months from submission. Colorectal Cancer Phase III Trials Starting Sanofi-aventis is starting an international, randomised, placebo-controlled Phase III trial of TroVax in colorectal cancer. The Phase III trial, which has been named FLAMENCO, is designed to assess TroVax as a first line treatment of patients with Stage IV metastatic colorectal cancer. It is expected to enrol approximately 1,300 patients. The trial design is similar to the TRIST study, in that it will evaluate TroVax in combination with standard of care versus placebo plus standard of care. The standard treatment will be chemotherapy with or without Avastin(R) (bevacizumab), which will be stratified between the two arms of the study. The primary endpoint will be overall survival and the trial will include an interim analysis to evaluate time to disease progression. The trial will be conducted under a SPA with the FDA and patient recruitment is expected to start in mid-2008. Results from the interim analysis are anticipated in 2010. In addition to the Phase III trial in metastatic colorectal cancer, the UK clinical trials network QUASAR is starting a trial of TroVax in early-stage colorectal cancer. This trial is supported by both sanofi-aventis and Oxford BioMedica. Sanofi-aventis will act as the US regulatory agent for the trial, which has been submitted to the US and UK regulatory authorities. The trial will assess TroVax in patients with Stage II/III colorectal cancer who have had surgical resection of their primary tumours and been treated with adjuvant chemotherapy. It is expected to enrol approximately 3,000 patients and has been designed with a primary endpoint of three-year disease-free survival. The funding of the QUASAR trial derives from a variety of sources, including the UK Medical Research Council and the Department of Health as well as Oxford BioMedica and sanofi-aventis. Patient recruitment is expected to commence in mid-2008. Update on US-sponsored Breast Cancer Trial Over the last two years, we have been liaising with the SouthWest Oncology Group (SWOG), which is one of the largest cancer clinical trials cooperative groups in the USA, funded by research grants from the US National Cancer Institute, part of the National Institutes of Health. SWOG was planning to conduct a Phase II trial of TroVax in patients with advanced breast cancer. Since TroVax is being evaluated in a major Phase III programme, SWOG, Oxford BioMedica and sanofi-aventis have now concluded that an open-label Phase II study of TroVax to evaluate safety and immunology in this patient group is no longer necessary. SWOG remains committed to the TroVax programme, and we are working with the organisation to design a larger study of TroVax in breast cancer. Encouraging Results from Phase II Trials in Renal Cancer At the Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2007, new data were reported from two Phase II trials of TroVax in renal cancer. TroVax was well tolerated with no serious adverse events attributable to the treatment and the product induced anti-5T4 antibody responses in 91% of patients. Twenty-four of 35 evaluable patients with clear cell renal carcinoma (68%) showed disease control. Two patients had complete responses (i.e. their tumours were completely eradicated), three had partial responses (i.e. tumour shrinkage) and 19 had stable disease for periods exceeding three months, including three patients that were stable for more than 17 months. Preliminary analysis of clinical benefit showed a statistically significant relationship between reduction in tumour burden in patients with clear cell renal carcinoma and patients' anti-5T4 antibody responses (p=0.028). These encouraging new data support the hypothesis that the 5T4-specific immune response induced by TroVax has therapeutic benefit. Presentation of Final Phase II Results Together with sanofi-aventis, we aim to present final data from all four open-label Phase II trials of TroVax in renal cancer at ASCO in May/June 2008. The trials evaluated TroVax as a single agent and in combination with high-dose interleukin-2, low-dose interleukin-2 or interferon-alpha. Separately, we plan to report results from the completed Phase II trial of TroVax in prostate cancer at the Targeted Anticancer Therapies meeting, 20-22 March 2008, in the USA. The trial, in 27 patients with hormone-refractory prostate cancer, evaluated TroVax as a single agent and in combination with the standard therapy, granulocyte-macrophage colony-stimulating factor (GM-CSF). Preliminary data from this trial were previously reported in April 2007 at the Annual Meeting of the American Association for Cancer Research, showing that TroVax was well tolerated and all patients developed anti-5T4 antibody responses. Pre-commercialisation Plan The presentation of clinical data at upcoming conferences is part of the pre-commercialisation plan for TroVax ahead of the Phase III TRIST study results and potential registration in 2009. Sanofi-aventis is implementing a communications initiative to inform and educate the oncology community with regards to TroVax ahead of its potential launch. The companies have secured manufacturing for commercial launch, together with material for the Phase III trials in colorectal cancer. Discussions are ongoing with sanofi-aventis and our contract manufacturer regarding longer-term supply. Sanofi-aventis is evaluating its manufacturing strategy, which may include an in-house manufacturing facility for TroVax. Summary We are delighted by the progress of the TroVax programme and by the commitment of our partner, sanofi-aventis. By combining Oxford BioMedica's expertise in cancer immunotherapy and the experience of sanofi-aventis in clinical development and commercialisation of oncology products, we hope to be able to bring this innovative and potentially valuable medicine to patients as soon as possible. PROSAVIN(R) The first clinical trial of ProSavin in Parkinson's disease is underway in France. It is the first trial using our proprietary LentiVector technology and, as such, represents a major event for Oxford BioMedica and the future of the pipeline of products that use the same technology. The superior efficacy of ProSavin combined with the absence of side effects in preclinical studies suggest that ProSavin could be used to replace standard L-DOPA therapy in patients with moderate to late-stage Parkinson's disease. Following our discussions with the regulatory agency in France, we have started preparations to move from this Phase I/II trial directly into a Phase III trial, which could start at the end of 2009 or early 2010. Phase I/II Trial Initiated In December 2007, we opened the Phase I/II trial of ProSavin, having received regulatory clearance from the French Health Products Safety Agency (AFSSAPS) for our Clinical Trial Application (CTA). The CTA was submitted in July 2007. Patient recruitment is underway at the Henri Mondor Hospital in Paris, which is a European centre of excellence for neurosurgery and a member of the Assistance Publique Hopitaux de Paris (APHP) in France. Several patients are undergoing detailed evaluation of their baseline Parkinsonian status prior to surgical administration of ProSavin. Treatment of the first patient is imminent. The primary objectives of the trial are to assess the safety and efficacy of ProSavin. The analyses of patients will include the application of advanced non-invasive neuro-imaging techniques. Phase I/II Trial Design Patients in the trial will have been diagnosed with Parkinson's disease and will be failing on current treatment with L-DOPA but they will not have progressed to experiencing drug-induced movement disorders (dyskinesias). It is a two-stage study. The first stage is an open-label dose escalation to evaluate two dose levels of ProSavin in cohorts of three patients each. In the second stage of the trial, a further 12 patients will be recruited. Four of the 12 patients will act as a control group and only receive 'sham' surgery. ProSavin is administered locally to the brain, converting the target cells into a dopamine factory, thus replacing the patient's own lost source of the neurotransmitter. The surgical procedure for administration of ProSavin entails stereotactic bilateral injection into the striatum of the brain under general anaesthesia using MRI-imaging and mapping. The procedure is designed to be non-destructive to tissue and does not leave any device in the brain. The efficacy of ProSavin will be assessed using the Unified Parkinson's Disease Rating Score (UPDRS). Patients will be monitored at regular intervals, with the primary endpoint being an efficacy assessment at six months after treatment. The secondary objective of the trial is to asses the extent to which patients' current therapy (L-DOPA) can be reduced or removed following administration of ProSavin. Sustained Efficacy in Preclinical Studies We continue to assess the long-term efficacy data of ProSavin in a preclinical setting. In the industry-standard preclinical model of Parkinson's disease, known as the MPTP model, ProSavin induces almost complete recovery of movement function and other behavioural measurements following a single administration. In this model, the most recent time point shows that the therapeutic effect of ProSavin has been maintained for over 27 months with no diminution. Efficacy was similar to that expected with standard daily treatment with L-DOPA but with no evidence of the dyskinesias associated with prolonged L-DOPA treatment. Phase III Preparations If the safety and efficacy observed in preclinical studies of ProSavin is replicated in the Phase I/II trial, then we would aim to move directly to a Phase III trial. Based on our anticipated timelines for the Phase I/II trial and for scaling-up the manufacture of ProSavin for Phase III and commercialisation, the Phase III trial could start in late 2009 or early 2010. The trial could be completed within two years, supporting first product registration in 2012-13. Summary Current standard therapy for Parkinson's disease is only partially effective in the mid to late stage of disease and can induce debilitating side effects after long-term use. ProSavin has the potential to address this unmet medical need, offering long-lasting benefit from a single administration with an excellent safety profile. We are pleased to have started our first clinical trial of this potentially important new treatment approach for Parkinson's disease. The product could significantly expand the worldwide market for Parkinson's disease therapies, which are estimated to generate sales in excess of US$3 billion, by reducing the social care burden associated with the mid to late-stage of disease. The LentiVector system used within ProSavin is common to multiple preclinical candidates in our pipeline. The infrastructure for ProSavin that relates to manufacturing scale-up and safety testing can be applied across this portfolio. Hence, the time invested in the ProSavin programme should benefit our other LentiVector-based programmes. HI-8(R) MEL Hi-8 MEL is a therapeutic vaccine for metastatic melanoma, which was added to the pipeline following the Company's acquisition of Oxxon Therapeutics in March 2007. Oxxon Therapeutics had previously evaluated Hi-8 MEL in two clinical trials. These trials showed that the vaccine was well tolerated and produced strong killer T-cell immune responses against the cancerous cells at certain dose levels. The product has the potential to reduce mortality in patients with advanced disease, and can be used alongside standard therapy without adding significant toxicity. Hi-8 MEL is based on the same MVA vector technology as TroVax, together with a DNA-based configuration of the vaccine. If melanoma is treated early it can be cured by surgical resection. However, half of those with metastatic melanoma die of the disease within five years. A melanoma vaccine would offer new hope to such patients. Encouraging Update on Phase II Trial in Melanoma Updated results from a Phase II trial were presented at the American Association of Immunologists Annual Meeting in May 2007. The trial, in 41 patients with Stage III/IV melanoma, was designed to evaluate the immune and clinical responses elicited by Hi-8 MEL. The product was highly immunogenic with 91% of patients that received the optimal dose showing an antigen-specific immune response. Eight patients (20%) showed periods of disease control. The presentation included follow-up of one patient that exhibited a sustained partial response for more than two years. The median survival for immune responders was 100 weeks versus 37 weeks for non-responders (p < 0.001). Strategy for future development The Company believes information garnered from the ongoing TroVax studies will provide additional useful information on how best to develop Hi-8 MEL, which is a MVA-based tumour vaccine, like TroVax. We are reviewing the current formulation and data generated by Oxxon to ensure that Hi-8 MEL is ready for full development pending successful completion of the Phase III TRIST study of TroVax. Summary Melanoma is one of only a few cancers in which the immune system appears to play a prominent role. The 5T4 antigen, that is the basis of TroVax, is not found on melanoma cells. Hence, Hi-8 MEL is an ideal complement to the potential applications of TroVax in solid tumours. Through our experience with TroVax, we have substantial expertise in cancer immunotherapy. We will apply this knowledge to the further development of Hi-8 MEL. METXIA(R) MetXia is potentially useful in the treatment of a number of solid tumours and their metastases, particularly those where cyclophosphamide is commonly used as a treatment. The product is being evaluated in a Phase II trial in pancreatic cancer. The trial is a dose-escalation study to identify the optimal dose levels for MetXia and cyclophosphamide. In 2007, we initiated commercial discussions with potential partners for both MetXia and our associated technology for Gene-Directed Enzyme Prodrug Therapy (GDEPT). Patient Recruitment Progressing in Phase II Trial We initiated the Phase II trial of MetXia in 2004 in patients with non-resectable pancreatic tumours. The recruitment of patients has been purposefully staged since each patient needs to be carefully reviewed for their response to therapy prior to treatment of subsequent patients. However, the rate of enrolment in this trial has been problematic due to the strict criteria for patient suitability and the poor health of the majority of patients presenting for surgery. The patients are at an advanced stage of their disease, and most have previously failed to respond to other therapies. To date, 23 patients have been treated in the study, in which MetXia and cyclophosphamide are delivered directly to the pancreatic tumour via a catheter inserted through an artery. Two dose levels of MetXia and five dose levels of cyclophosphamide have been evaluated to assess the efficiency of P450 gene transfer and to determine the maximum tolerated dose of the prodrug. Preliminary Proof of Concept Results in Phase II Trial Patients who received the optimal dose of MetXia and higher doses of cyclophosphamide are still being assessed. Preliminary results suggest that MetXia induces gene expression of P450 enzyme at the tumour site and that there have been no unexpected adverse events when MetXia and cyclophosphamide are used together in this manner. To date, disease stabilisation has been evident in six of 12 evaluable patients (50%). Patient survival is difficult to interpret for this heterogeneous patient group but has ranged from four to almost 110 weeks. Median survival for the evaluable patients is 26 weeks. Additional patients are being recruited at the maximum tolerated dose to establish more efficacy data in this patient group. We plan to report further data from this trial during 2008. Initiated Commercial Discussions Following our strategic review in 2007, we initiated discussions with potential partners for further development and commercialisation of MetXia. This will enable us to focus our resources on higher development priorities within the pipeline. MetXia is the most advanced product candidate to derive from our proprietary GDEPT technology. To maximise the commercial opportunity for MetXia and our GDEPT technology, we are seeking industry partners to provide additional resources and expertise. Summary Preliminary data from the Phase II trial in non-resectable pancreatic cancer are encouraging and demonstrate proof of concept for our GDEPT technology. This platform technology has the potential for broad application. With appropriate investment, MetXia could be the first of multiple GDEPT-based products developed for the treatment of localised, accessible tumours. RETINOSTAT(R) RetinoStat is designed to provide long-term inhibition of aberrant blood vessel growth in the retina for the treatment of vision loss caused by conditions such as wet age-related macular degeneration (AMD) and diabetic retinopathy (DR). We have identified RetinoStat as our next LentiVector-based programme for clinical development, behind ProSavin. Our aim is to conduct an initial clinical trial in the USA, since the programme is supported by US organisations, namely Johns Hopkins University and the Foundation Fighting Blindness with its support organisation, the National Neurovision Research Institute. New Proof of Concept Preclinical Results In May 2007, Oxford BioMedica and our collaborators at Johns Hopkins University in Baltimore presented encouraging preclinical data with RetinoStat at the Association for Research in Vision and Ophthalmology Annual Meeting. The presentation included preclinical proof of principle in an industry-standard model of neovascular AMD. Ongoing Clinical Preparations We have initiated the scale-up process for manufacturing clinical material. We have commissioned Good Manufacturing Practice (GMP) production of a key component of RetinoStat and we aim to have final clinical material within the next 12 months. With our US collaborators, we are conducting additional non-clinical studies with RetinoStat that are required for our regulatory submission to start clinical trials. During 2007, our internal resources for LentiVector-based programmes were prioritised to ProSavin, which has extended our anticipated timelines for RetinoStat. However, the development of RetinoStat should benefit considerably from our investment in the manufacturing of ProSavin. We expect to submit an Investigational New Drug (IND) application to the FDA for the start of trials in patients with wet AMD during 2009. Summary We have had initial discussions with potential partners for further development and commercialisation of RetinoStat. The industry is clearly interested in new anti-angiogenic treatment strategies for wet AMD, which have potential for superior efficacy and a lower injection frequency than the current standard therapy, which is Novartis' Lucentis(R). Treatment with Lucentis requires injections into the eye every one to two months. Given the long-term gene expression capabilities of our LentiVector technology, a single administration of RetinoStat could be effective for over a year. EARLY-STAGE CANDIDATES We have established a diverse early-stage pipeline that comprises eight preclinical product candidates. The in-house programmes are all gene-based therapies that utilise our LentiVector technology. In 2007, several of these programmes benefited from financial support provided by disease-focused charitable organisations through direct funding of studies or grants. During 2007, we initiated a new anti-cancer programme, EndoAngio-GT, and presented preclinical proof-of-concept results with StarGen in Stargardt's disease. Initiated EndoAngio-GT Anti-cancer Programme In July 2007, we secured a licence from Children's Hospital Boston to the anti-angiogenic genes that are utilised in our RetinoStat vision loss programme for the treatment of cancer. This new anti-cancer programme, EndoAngio-GT, is based on a similar construct to RetinoStat. In 2007, we initiated preclinical optimisation of the product. Presentation of StarGen(TM) Preclinical Results StarGen is designed to deliver a normal functional gene to treat an inherited ocular condition, Stargardt's disease. The programme is funded by the Foundation Fighting Blindness, the National Neurovision Research Institute and a consortium of associated investors. At the Association for Research in Vision and Ophthalmology Annual Meeting in May 2007, we presented preclinical data with StarGen, showing efficacy in an industry-standard model of the disease. Additional preclinical studies are underway at Columbia University in New York, which could support advancement to clinical development in this niche commercial market. In addition to our relationship around StarGen and RetinoStat, we are exploring a commercial collaboration with the Foundation Fighting Blindness to develop LentiVector-based therapeutic approaches for other ocular diseases. TECHNOLOGY LICENSING Our technology licensing activities exploit the potential of our suite of gene delivery technologies by providing third-party access for research or specific development applications. We have added two new industry partners to our list of licensed LentiVector users and we entered the field of RNA interference using our LentiVector system for genetic delivery. In addition, one of our partners announced the start of a Phase III trial with a product that uses another of our technologies, which triggered a milestone payment. New LentiVector Licensing Agreement In July 2007, another major US-based biotechnology company licensed the LentiVector gene delivery technology for research activities in a joint agreement with Sigma-Aldrich. Sigma-Aldrich is our strategic partner and exclusive licensee for the commercialisation of the LentiVector technology for research use. In addition, in March 2008, as part of a patent dispute settlement, Open Biosystems acquired certain rights for use of our LentiVector technology in research activities. Expanding into Therapeutic RNA Interference In January 2008, we signed a license agreement with the Carnegie Institution of Washington and the University of Massachusetts Medical School that grants Oxford BioMedica rights to key RNA interference (RNAi) technology invented by Nobel Prize-winning scientists Andrew Z. Fire, PhD, and Craig C. Mello, PhD. The licence is exclusive for therapeutic RNAi strategies using our LentiVector technology. RNAi represents a potential new strategy for treating diseases by gene silencing. We plan to develop LentiVector-based RNAi therapies independently, but also offer this technology to our existing LentiVector licensees and other industry players as part of our technology licensing activities. MolMed Initiates Phase III Trial Also in January 2008, one of our partners, MolMed, received regulatory approval to start a Phase III trial of its TK therapy. The Phase III trial is being conducted in Italy in patients with high risk acute leukaemia who are receiving haematopoietic stem cell transplantation. The product is a cell/gene-based therapy that is designed to control the complications of graft versus host disease associated with these transplantations. The product employs our ex vivo retroviral gene delivery technology. The start of this Phase III trial triggered a milestone payment to Oxford BioMedica under the terms of our agreement. Viragen Streamlines its Research Another partner, Viragen, which licensed our LentiVector technology for the development of an avian transgenic biomanufacturing system, reported further progress with the technology and published results in a leading medical journal in January 2007. However, in June 2007, Viragen halted development as part of its efforts to cut costs and has subsequently sought bankruptcy protection. With the Roslin Institute, which was collaborating with Viragen on this programme, we are exploring alternative ways to advance and commercialise the avian transgenic technology. INTELLECTUAL PROPERTY Our intellectual property estate is fundamental to our business to ensure that we control and protect our products in development and our technologies. In 2007, we bolstered our proprietary position in immunotherapy through the acquisition of Oxxon Therapeutics. At the end of 2007, our estate comprised 46 US and 20 European issued patents compared to 39 and 12, respectively, in the previous year. During 2007, we were granted five patents in the USA and five in Europe. We have a further 76 patents issued in other jurisdictions, with four of these being granted in 2007. In total, 198 patent applications are currently pending. Another 24 patent families, covering key technologies, are licensed from third parties. In 2007 and early 2008, respectively, we announced two significant in-licensing deals of intellectual property. Firstly, we extended our rights to use two anti-angiogenic genes for the treatment of cancer. Secondly, we secured exclusive rights in the field of RNA interference for the development of therapeutics using our LentiVector technology. Furthermore, in March 2008, Oxford BioMedica, our partner, Sigma-Aldrich, and Open Biosystems settled a patent dispute over use of our LentiVector technology in research reagents. Oxxon Acquisition Adds Immunotherapy IP Our acquisition of Oxxon Therapeutics in March 2007 has added intellectual property in immunotherapy to our estate. Its Hi-8(R) PrimeBoost technology is a pioneering method for producing a potent and specific T-cell immune response against diseased cells. This platform has potential applications in developing prophylactic as well as therapeutic vaccines. Oxxon owned or had exclusively licensed a number of patent families covering the PrimeBoost technology and these patents and licences are now part of Oxford BioMedica's estate. Extended Rights to Anti-angiogenic Genes In July 2007, we signed a license agreement with Children's Hospital Boston to extend our existing rights for the anti-angiogenic genes, endostatin and angiostatin, for the treatment of cancer. This has enabled us to initiate a new anti-cancer development programme, EndoAngio-GT. We previously licensed rights to these genes solely for the treatment of ocular diseases, and the genes are being successfully employed in RetinoStat. We expect the development of EndoAngio-GT to benefit from synergies with RetinoStat. New Rights in Therapeutic RNA Interference In January 2008, (as described in Technology Licensing above) we licensed Nobel prize-winning RNA interference (RNAi) technology from the Carnegie Institution of Washington and the University of Massachusetts Medical School. This agreement provides exclusive rights to use our LentiVector technology for therapeutic RNAi applications. We plan to develop LentiVector-based RNAi therapies, both independently and through collaborations. FINANCIAL REVIEW Financial overview The TroVax collaboration with sanofi-aventis has transformed the Group's finances. A total of £25.8 million cash was received in 2007 from sanofi-aventis. Of this amount, £7.0 million was recognised as revenue in 2007 and £18.8 million is classified as deferred income. In addition, the acquisition of Oxxon Therapeutics Limited (Oxxon) in March 2007 for £16.0 million, which was satisfied by Oxford BioMedica shares, brought with it cash and cash equivalents of £3.8 million. Overall, there was a net increase in cash, cash equivalents and current asset investments in the year of £9.6 million. Revenue £7,219,000 (2006: £760,000) The TroVax collaboration with sanofi-aventis accounts for the majority of revenue in 2007. A total of £25.8 million cash was received in 2007, comprising an initial payment of £19.7 million (€29 million) on commencement in March 2007 and the first development milestone payment of £6.1 million (€9 million) in September 2007. Revenue from these payments is being recognised on a straight-line basis over the period to certain clinical events, which are anticipated in 2009 and 2010. £7.0 million was recognised as revenue in the 2007 income statement. The remaining £18.8 million is classified as deferred income. Revenue from technology licensing in 2007 amounted to £0.2 million compared to £0.8 million in the previous year. Licenses that provide access to our technology for research use generate minimal revenue but potentially facilitate collaborations for product development. Cost of sales £449,000 (2006: £80,000 included in operating expenses) We have licensed a number of third-party technologies to expand our activities and to ensure that we have freedom to operate. Most licences include royalties payable on sales, and some include royalties payable on licensing income, including up-front and milestone income. In 2007, £0.4 million of royalties were recognised in cost of sales in the Group's income statement. The amounts of royalty payable on revenue in previous years were lower, and were included in operating expenses. Operating expenses £26,759,000 (2006: £22,222,000) Operating expenses increased by 20% in 2007 to £26.8 million, reflecting increased employee costs, the acquisition of Oxxon and higher legal and professional expenses associated with our patent estate and the licensing of TroVax. Research & development costs £22,142,000 (2006: £19,523,000) R&D costs increased by 13% in 2007 to £22.1 million. Our R&D expenditure comprises in-house costs (staff, R&D consumables, intellectual property, facilities and depreciation of R&D assets) and external costs (preclinical studies, GMP manufacturing, regulatory affairs, and clinical trials). In 2007, as in 2006, external preclinical and clinical costs were the largest contributors to R&D spend. The year was also impacted by the addition of £0.3 million in R&D costs associated with Oxxon. Administrative expenses £4,617,000 (2006: £2,699,000) The increase in administrative expenses in 2007 was partly due to the acquisition of Oxxon and increased legal and professional costs. In 2007, there was a charge of £0.3 million for exceptional closure and reorganisation of Oxxon, and £0.1 million for non-exceptional administrative expenses during the close-down period. Legal and professional costs related to the collaboration with sanofi-aventis and other negotiations were £0.4 million. Finance income £2,087,000 (2006:£1,714,000) The Group places its cash in bank deposits for periods of up to 12 months and generates interest on those deposits. The maturity profile of deposits is intended to match planned patterns of expenditure. The average balance on deposit in 2007 was approximately the same as in 2006 at £37.7 million. However, due to higher interest rates in 2007, net interest receivable was up by 22%. The Group has no debt, but is recognising as a finance expense the discount on a lease provision and a dilapidation provision. Taxation Our UK operating subsidiaries are entitled to claim R&D tax credit. The credit is based on certain eligible expenses, to which a 50% mark-up and a tax rate of 16% are applied. Under the prevailing rules, the R&D tax credit cannot exceed the total amount of UK payroll tax (Income Tax and National Insurance) paid in the year. In 2007, our R&D tax credit increased 48% to £2.5 million, due to higher employee benefit expenses during the year. The year-end debtor for R&D tax credit of £2.6 million represents the estimated tax credit for the current year, including £0.1 million that is attributable to Oxxon in the period prior to our acquisition. Loss for the financial year £15,289,000 (2006: £17,626,000) The Group's loss for the year narrowed to £15.3 million from £17.6 million despite higher operating expenses in 2007. Intangible assets £14,910,000 (2006: £1,665,000) The Oxxon acquisition has resulted in a significant increase in intangible assets. The principal acquired intangibles were in-process research and development on the melanoma vaccine Hi-8 MEL, and the PrimeBoost patent portfolio. The fair value of these assets was £13.1 million. In addition, purchased intellectual property rights of £0.2 million were capitalised. Trade and other receivables £4,672,000 (2006: £2,202,000) Trade and other receivables (debtors) were £2.5 million higher in 2007 than in the previous year. There was an increase of £0.4 million in other receivables principally due to higher bank interest fixed-term deposits. Prepaid clinical trial expenses of £1.0 million (2006: nil) are materials for clinical trials not yet shipped to site, and advance payments to clinical sites. Trade and other payables £9,557,000 (2006: £4,671,000) The increase in trade and other payables (creditors) in 2007 was principally associated with our expanded clinical development activities. Deferred income £18,913,000 (2006: £92,000) The Group's deferred revenue at the end 2007 was boosted to £18.9 million. Deferred revenue reflects payments received under our licensing agreements that exceed the amount of recognised revenue. Receipts in 2007 from the TroVax collaboration with sanofi-aventis are being recognised as revenue over a two to three-year period. The amount expected to be recognised as revenue in 2008 is £11.4 million. Share issues At the end of 2007, the Group had 534,655,843 shares in issue. During the year, shares issued for cash raised £0.3 million before expenses from the exercise of share options and other subscriptions. A total of 31,771,246 shares with a value of £16.0 million were issued in the acquisition of Oxxon. Cash and deposits £38,147,000 (2006: £28,543,000). Operational cash generated £5,883,000 (2006: cash burn £15,876,000) The total of cash, cash equivalents and current asset investments at the end of 2007 was £38.1 million, compared to £28.5 million in the previous years. The format of the cash flow statement under IFRS does not make it easy to assess the overall level of operational cash flows that have traditionally been a key performance indicator for development-stage biotechnology companies. However, a useful measure can be calculated by taking the aggregate of cash from operating activities, proceeds of sale of property, plant and equipment and purchases of property, plant and equipment and intangible assets. On this measure, there was a positive operational cash flow of £5.9 million in 2007, in contrast to a (negative) cash burn in 2006 of £15.9 million. The key difference in 2007 was the receipt of £25.8 million from sanofi-aventis. In addition, cash and cash equivalents of £3.8 million were acquired with Oxxon. Financial outlook In 2007, we conducted a strategic review of our development pipeline to enable us to focus investment on opportunities that could generate the greatest value. The present level of operational expenses is expected to be maintained through 2008 based on our current and planned development activities. We reached the second development milestone in our agreement with sanofi-aventis in February 2008, which triggered a payment of €10 million. We will continue to monitor the investment requirements for each of our programmes and will expand our internal operations as required to meet our objectives. Our financial goal is to be profitable within 12 months of registration of our first product, which could be in 2009 following a successful outcome from the Phase III TRIST study of TroVax in renal cancer. OUTLOOK With a focused strategy and a strong financial position, we are well placed to deliver on our objectives for 2008. We are delighted to have recently triggered a further development milestone payment in our collaboration with sanofi-aventis, following the third successful review of the Phase III TRIST study by the DSMB. We expect shortly to complete recruitment for this trial. Over the next few years, sanofi-aventis is planning a significant investment in the TroVax programme. Our key goals for TroVax in 2008 include continued management of the TRIST study in renal cancer, and support for sanofi-aventis as it broadens the Phase III programme into colorectal cancer and prepares for the commercialisation of the product. ProSavin, our novel treatment for Parkinson's disease is potentially the next blockbuster opportunity in our pipeline. The Phase I/II trial is underway and we aim to report preliminary safety and efficacy data from the study during this year. Also in 2008, we aim take RetinoStat towards clinical development in wet AMD. As part of our strategy, we will continue to pursue collaboration opportunities for certain programmes. In 2008, we intend to move forward with our collaboration discussions for MetXia and its associated GDEPT technology for localised cancer therapy. Also, having secured a proprietary position in the field of therapeutic RNA interference, we plan to explore partnering opportunities that could provide additional near-term revenue. In summary, we are looking forward to an exciting period for Oxford BioMedica, which could see both TroVax and ProSavin reach key inflexion points in their development. Both products address large markets and potentially provide patients with new safe and effective treatment options. Hence, in our view, both products present substantial value propositions. Consolidated income statement for the year ended 31 December 2007 Notes 2007 2006 £'000 £'000 Revenue 2 7,219 760 Cost of sales (449) - Research and development costs (22,142) (19,523) Administrative expenses (4,617) (2,699) Administrative expenses comprise: Administrative expenses before exceptionals (4,282) (2,699) Exceptional administrative expenses 3 (335) - Total administrative expenses (4,617) (2,699) Other operating income: grants receivable 161 360 Operating loss (19,828) (21,102) Finance costs (30) (29) Finance income 2,117 1,743 Loss before tax (17,741) (19,388) Taxation 4 2,452 1,762 Loss for the financial year (15,289) (17,626) Basic loss and diluted loss per ordinary share 5 (2.9p) (3.5p) The notes on pages 16 to 22 form part of this financial information. Consolidated balance sheet as at 31 December 2007 Notes 2007 2006 £'000 £'000 Assets Non-current assets Intangible assets 6 14,910 1,665 Property, plant and equipment 7 810 819 15,720 2,484 Current assets Trade and other receivables 8 4,672 2,202 Current tax assets 2,623 2,309 Financial assets: Available for sale investments 9 27,185 20,500 Cash and cash equivalents 9 10,962 8,043 45,442 33,054 Current liabilities Trade and other payables 10 9,557 4,671 Deferred income 11 11,530 92 Current tax liabilities 14 - Provisions 12 60 58 21,161 4,821 Net current assets/(liabilities) 24,281 28,233 Non-current liabilities Other non-current liabilities 96 - Deferred income 11 7,383 - Provisions 12 590 627 8,069 627 Net assets 31,932 30,090 Shareholders' equity Ordinary shares 5,347 5,014 Share premium 109,101 106,732 Merger reserve 14,310 711 Other reserves (625) (627) Losses (96,201) (81,740) Total equity 31,932 30,090 The notes on pages 16 to 22 form part of this financial information. Consolidated cash flow statement for the year ended 31 December 2007 2007 2006 Notes £'000 £'000 Cash flows from operating activities Cash generated by/(used in) operations 13 2,307 (17,726) Interest received 1,567 1,440 Tax credit received 2,480 650 Overseas tax paid (57) (25) Net cash from operating activities 6,297 (15,661) Cash flows from investing activities Proceeds from sale of property, plant and equipment 7 1 Purchases of property, plant and equipment (259) (192) Purchases of intangible assets (162) (24) Net (purchase)/maturity of available for sale (6,685) 3,000 investments Cash and cash equivalents acquired with subsidiary 14 3,759 - Acquisition costs (382) - Net cash (used in)/generated by investing activities (3,722) 2,785 Cash flows from financing activities Net proceeds from issue of ordinary share capital 345 629 Effects of exchange rate changes (1) (27) Net increase/(decrease) in cash and cash equivalents 2,919 (12,274) Cash and cash equivalents at 1 January 8,043 20,317 Cash and cash equivalents at 31 December 9 10,962 8,043 The notes on pages 16 to 22 form part of this financial information. Statement of changes in shareholders' equity for the year ended 31 December 2007 Share Share Merger Translation Losses Total capital premium reserve reserve £'000 £'000 £'000 £'000 £'000 £'000 At 1 January 2007 5,014 106,732 711 (627)(81,740) 30,090 Exchange adjustments - - - 2 - 2 Loss for the year - - - - (15,289)(15,289) Total recognised - - - 2 (15,289)(15,287) expense for the year Shares issued in 318 2,083 13,599 - - 16,000 acquisition Share options 13 199 - - - 212 Proceeds from shares issued Value of employee - - - - 828 828 services Issue of shares 2 97 - - - 99 excl. options Costs of share - (10) - - - (10) issues At 31 December 2007 5,347 109,101 14,310 (625)(96,201) 31,932 The notes on pages 16 to 22 form part of this financial information. Notes to the financial information for the year ended 31 December 2007 1 Basis of preparation This financial information for the years ended 31 December 2007 and 31 December 2006 does not constitute the statutory financial statements for the respective years and is an extract from the financial statements. Financial statements for the year ended 31 December 2006 have been delivered to the Registrar of Companies and included the auditors' report. Financial statements for the year ended 31 December 2007 have not yet been delivered to the Registrar. The auditors' reports on the financial statements for the years ended 31 December 2007 and 31 December 2006 were unqualified and did not contain statements under either section 237(2) or section 237(3) of the Companies Act 1985. The financial information in this report does not constitute statutory accounts within the meaning of Section 240 of the Companies Act 1985. The financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) and International Financial Reporting Interpretations Committee (IFRIC) interpretations endorsed by the European Union and with those parts of the Companies Act 1985 applicable to companies reporting under IFRS. The financial statements are prepared in accordance with the historical cost convention as modified by revaluation of available for sale investments. Whilst the financial information included in this preliminary announcement has been prepared in accordance with IFRSs adopted for use in the European Union, this announcement does not itself contain sufficient information to comply with IFRSs. Copies of this announcement and the interim report for 2007 are available from the Company Secretary. The audited statutory financial statements for the year ended 31 December 2007 are expected to be distributed to shareholders by 31 March 2008 and will be available at the registered office of the Company, Medawar Centre, Oxford Science Park, Oxford, OX4 4GA. Details can also be found on the Company's website at www.oxfordbiomedica.co.uk. This announcement was approved by the Board of Oxford BioMedica plc on 7 March 2008. Use of estimates and assumptions The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Estimates and judgements are continually made and are based on historic experience and other factors, including expectations of future events that are believed to be reasonable in the circumstances. Critical accounting estimates and assumptions Where the Group makes estimates and assumptions concerning the future, the resulting accounting estimates will seldom exactly match actual results. Due to the amounts involved, the estimates and assumptions regarding revenue recognition and the amounts accrued for clinical trial costs have a greater risk of causing a material adjustment to the carrying amounts of assets and liabilities. Revenue from payments in 2007 by sanofi-aventis under the TroVax collaboration is being recognised on a straight-line basis over the estimated period to specific milestone events in 2009 and 2010, based on management's estimates of the timing of these events. Should the timing of these events differ from management's estimates, there could be a material effect on the income statement and on the amount of deferred revenue in the balance sheet. For clinical trial costs the Group uses a percentage-of-completion method to accrue for such costs. This method requires the Group to estimate the services performed by contractors to date as a proportion of total services to be performed. Notes to the financial information for the year ended 31 December 2007 (continued) 2 Segmental analysis The Group's primary segment reporting is by geographical location of assets, with business sector as the secondary format. Revenue and loss on ordinary activities before taxation are derived entirely from the Group's one business segment, biotechnology research and development. All costs of acquisition of property, plant and equipment and intangible assets as well as depreciation expense borne by the Group relate to this one segment In addition, all other non-cash expenses incurred by the Group relate to this one segment. The two geographic locations comprise the Group's UK and US operations. The majority of the Group's activities take place in the United Kingdom, with the United States subsidiary providing intellectual property management and business development support to the United Kingdom operation. Purchases and sales between subsidiaries are eliminated on consolidation. The Group's revenue derives from assets located in the United Kingdom. By destination, revenue derives from the European Union and the United States of America. 2007 2006 Revenue by destination £'000 £'000 Europe 7,021 56 United States of America 198 704 Total revenue 7,219 760 3 Exceptional administrative expenses Exceptional administrative expenses of £335,000 (2006: nil) were restructuring costs associated with the integration of Oxxon Therapeutics Limited ('Oxxon') and closure of the former Oxxon offices and laboratories following the acquisition of Oxxon in March 2007. Severance and related costs for former Oxxon employees were £247,000. Fixed asset write-offs (mostly leasehold improvements) were £73,000. Other expenses were £15,000. The cash outflow associated with the exceptional expenses was £262,000 (2006: nil). 4 Taxation The Group is entitled to claim tax credits in the United Kingdom for certain research and development expenditure. The amount included in the financial statements for the year ended 31 December 2007 represents the credit receivable by the Group for the year and adjustments to prior periods. These amounts have not yet been agreed with the relevant tax authorities. 2007 2006 Continuing operations £'000 £'000 Current tax United Kingdom corporation tax research and development credit (2,526) (1,709) Overseas taxation 60 38 (2,466) (1,671) Adjustments in respect of prior periods United Kingdom corporation tax research and development credit - (75) Overseas taxation 14 (16) Taxation credit (2,452) (1,762) Notes to the financial information for the year ended 31 December 2007 (continued) 5 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 528,024,022 in issue during the year ended 31 December 2007 (2006: 499,865,620). 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. 6 Intangible assets In process Intellectual Total R&D property rights £'000 £'000 £'000 Cost At 1 January 2007 - 1,927 1,927 Additions - through business combination 10,400 2,686 13,086 (note 14) Additions - 167 167 At 31 December 2007 10,400 4,780 15,180 Accumulated amortisation and impairment At 1 January 2007 - 262 262 Impairment in the year - 8 8 At 31 December 2007 - 270 262 Net book amount at 31 December 2007 10,400 4,510 14,910 Net book amount at 31 December 2006 - 1,665 1,665 In-process research and development acquired in 2007 comprises the fair value of the Hi8-MEL therapeutic vaccine for the treatment of melanoma. Intellectual property rights acquired through acquisition comprise the Oxxon Therapeutics patent portfolio covering therapeutic vaccines and prime-boost methods. Notes to the financial information for the year ended 31 December 2007 (continued) 7 Property, plant and equipment Short Office Computer Laboratory Total leasehold equipment, equipment equipment improvements fixtures and fittings £'000 £'000 £'000 £'000 £'000 Cost At 1 January 2007 2,608 87 281 2,670 5,646 Exchange adjustments (4) - - - (4) Additions - through 79 10 2 8 99 business combination (note 14) Additions - separately 20 7 75 174 276 Dilapidation asset - 8 - - - 8 effect of change in discount rate Disposals (79) (9) (63) (26) (177) At 31 December 2007 2,632 95 295 2,826 5,848 Accumulated depreciation At 1 January 2007 2,267 81 224 2,255 4,827 Exchange adjustments (4) - - - (4) Charge for the year 93 6 41 174 314 Disposals (12) (3) (63) (21) (99) At 31 December 2007 2,344 84 202 2,408 5,038 Net book amount at 288 11 93 418 810 31 December 2007 Net book amount at 31 341 6 57 415 819 December 2006 8 Trade and other receivables 2007 2006 £'000 £'000 Non-current Other receivables - rent deposit 118 150 Current Trade receivables 91 241 Other receivables 1,129 765 Other tax receivable 414 220 Prepaid clinical trial expenses 969 - Other prepayments 1,917 603 Accrued income 34 223 4,554 2,052 Total trade and other receivables 4,672 2,202 Prepaid clinical trial expenses comprise stocks of materials for use in clinical trials and advance payments to clinical trial sites. Notes to the financial information for the year ended 31 December 2007 (continued) 9 Cash and cash equivalents 2007 2006 £'000 £'000 Cash at bank and in hand 5,402 2,343 Short term bank deposits 5,560 5,700 Total cash and cash equivalents 10,962 8,043 In addition to the cash and cash equivalents described above, the Group held Sterling bank deposits of £27,185,000 (2006: £20,500,000) with an initial term to maturity between three and twelve months classified as available for sale investments. Group cash at bank and in hand includes £76,000 (2006: £182,000) held in escrow for expenses of the TRIST Phase III clinical trial. 10 Trade and other payables - current 2007 2006 £'000 £'000 Trade payables 2,948 1,579 Other taxation and social security 418 315 Accruals 6,191 2,777 Total trade and other payables 9,557 4,671 11 Deferred income In 2007 non-refundable payments totalling €38,000,000 (£25,793,000) were received from sanofi-aventis under the TroVax licence agreement. These payments are being recognised as revenue over a period of 24 to 36 months. To date revenue recognised under the sanofi-aventis collaboration is £6,970,000. At 31 December 2007 the Group had deferred income of £18,913,000 (2006: £92,000). £11,530,000 (2006: £92,000) is expected to be recognised as revenue within 12 months of the balance sheet date, and is classified as current; the remaining £7,383,000 (2006: nil) is classified as non-current. 12 Provisions Group Dilapidations Onerous Total lease £'000 £'000 £'000 At 1 January 2007 347 338 685 Exchange adjustments - (5) (5) Utilised in the year - (71) (71) Amortisation of discount 16 14 30 Change of discount rate - charged to income - 3 3 statement Change of discount rate - adjustment to recognised 8 - 8 fixed asset At 31 December 2007 371 279 650 At 31 December 2006 347 338 685 2007 2006 £'000 £'000 Current 60 58 Non-current 590 627 Total provisions 650 685 Notes to the financial information for the year ended 31 December 2007 (continued) 12 Provisions (continued) The dilapidations provision relates to anticipated costs of restoring the leasehold property in Oxford, UK to its original condition at the end of the present leases in 2011, discounted at 4.32% per annum (2006: 4.96%). The provision will be utilised at the end of the leases if they are not renewed. The onerous lease provision relates to the estimated rental shortfall in respect of a redundant property in San Diego, USA which has been sub-let for the remainder of the lease term until June 2012, discounted at 4.39% per annum (2006: 4.88% per annum).The provision will be utilised over the term of the lease. 13 Cash flow from operating activities Reconciliation of loss before tax to net cash from operations 2007 2006 £'000 £'000 Continuing operations Loss before tax (17,741) (19,388) Adjustment for: Depreciation 314 537 Loss/(profit) on disposal of property, plant and 77 (1) equipment Impairment of intangible assets 8 - Finance income (2,117) (1,743) Finance expense 30 29 Charge in relation to employee share schemes 828 451 Changes in working capital: Increase in trade and other receivables (1,880) (107) Increase in payables 4,036 2,596 Increase/(decrease) in deferred income 18,821 (13) (Decrease) in provisions (69) (87) Net cash generated by/(used in) operations 2,307 (17,726) 14 Acquisition of Oxxon Therapeutics Limited On 9 March 2007 the Company purchased the entire issued share capital including all voting rights of Oxxon Therapeutics Limited ('Oxxon'). In addition, a loan of £1.7 million to Oxxon from the former owners of Oxxon was acquired. The purchase has been accounted for as an acquisition. The assets acquired included cash and cash equivalents of £3.8 million. On 2 April 2007 in an internal reorganisation, the trade of Oxxon Therapeutics Limited together with all its assets and liabilities was sold to the Group's principal operating subsidiary Oxford BioMedica (UK) Limited, and Oxxon is now dormant. The purchase consideration, including the acquisition of the loan was £16,000,000 which was satisfied by the issue of 31,771,246 new 1p ordinary shares at 50.36p per share (the average market price over the 30 days ended 8 March 2007). From the date of acquisition to 2 April 2007 the net loss of Oxxon was £95,000. From 2 April 2007 the Oxxon business was integrated with that of Oxford BioMedica (UK) Limited, and the facilities formerly occupied by Oxxon were closed down. Since 2 April 2007 the net loss attributable to the Oxxon business was approximately £517,000 of which closure and severance costs of £335,000 were classified as exceptional administrative expenses. Had the acquisition taken place at the beginning of 2007 these amounts would not have been materially different. All intangible assets have been recognised at their respective fair values. There was no residual excess of the consideration over the fair value of net assets acquired, so no goodwill has been recognised in the financial statements. Notes to the financial information for the year ended 31 December 2007 (continued) 14 Acquisition of Oxxon Therapeutics Limited (continued) Acquisition of Oxxon Therapeutics Limited Carrying Fair value Fair value values pre adjustment acquisition £'000 £'000 £'000 Intangible assets 243 12,843 13,086 Property, plant and equipment 99 - 99 Receivables 100 - 100 Payables (930) - (930) R&D tax credit receivable 268 - 268 Deferred tax liability on fair value of - (3,926) (3,926) intangibles Deferred tax asset - tax losses - 3,926 3,926 Cash and cash equivalents 3,759 - 3,759 Loans (1,700) 1,700 - Net assets acquired 1,839 14,543 16,382 Goodwill - Consideration 16,382 Consideration satisfied by: Shares issued to acquire Oxxon share capital 13,875 Shares issued to acquire loan from former 2,125 parent of Oxxon Expenses of acquisition 382 16,382 The net inflow of cash and cash equivalents on the acquisition of Oxxon was: £'000 Cash and cash equivalents acquired 3,759 Cash costs of acquisition (382) 3,377 The fair value of the intangibles acquired with Oxxon was: £'000 In-process R&D: Hi-8 MEL melanoma vaccine 10,400 Intellectual property rights: prime-boost technology 2,686 13,086 This information is provided by RNS The company news service from the London Stock Exchange
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