Final Results

Proteome Sciences PLC 26 June 2003 For immediate release 26th June 2003 PRELIMINARY RESULTS FOR THE 12 MONTHS TO 31ST DECEMBER 2002 HIGHLIGHTS • Preliminary results • Acquisition of the proteomics activities from Aventis R&T completed the transformation of Proteome Sciences into a global leadership position in applied proteomics. • Established strong business development team and concluded two commercialisation deals. • Developed ProteoSHOPTM, a unique proteomics toolbox of proprietary next generation technologies for disease biomarkers. • Loss for year on ordinary activities after taxation of £4.1 million (2001: £2.0 million loss). • Cash balance at end of year of £4.3 million. • Placing • Placing with institutional investors on 26th June 2003 at 122p per share raised £5.8 million, representing 5% of the Company's share capital. • Commercialisation • Licensing and development deal with Biosite Inc, in December 2002, for detection of stroke in blood. • Completion of licensing deal with IDEXX Laboratories Inc, in April 2003, for BSE biomarkers in cattle and TSEs in other animals. The market for testing cattle in the EU projected to be €450 million annually. • Current Outlook • Further commercialisation of stroke markers in high throughput testing expected over next 12 months. • Licensing from the TSE programme in areas of blood transfusion screening and diagnosis of CJD and vCJD. • Strong newsflow and commercialisation expected from other disease programmes including acute and chronic organ rejection. • Sensitizer(R) technology expected to be out-licensed. • Current Outlook (continued) • PST and TMT technologies have attracted considerable commercial interest following their launches in the USA and Europe. • Dr Sandra Steiner joined the Company as Research and Development Director in May, completing the executive management team. • Commercialisation has provided revenue in 2003 and will generate both revenue and royalties in 2004. • Revenue from out-licensing, funded research, strategic alliances, grants and proprietary income. • Intronn Inc. • SMART(R) technology platform used successfully to correct cystic fibrosis gene defect in human cell model and repaired mutant Factor VIII (haemophilia) RNA. • Research collaboration with ProBioGen Inc, for cell line development. • Novel applications for SMART(R) in molecular imaging and for diagnostics and drug development. • Moved into purpose built facilities with several key appointments made during the year - total headcount to 26. • Veri-Q Inc. • Concluded licensing agreement with North Carolina State University in July 2002 relating to impurity levels in oligonucleotides. • Well underway to out-license technology across a range of applications, with commercialisation expected later in the year. Commenting on the results for 2002 and on current year progress, Christopher Pearce, Chief Executive of Proteome Sciences, said: 'The last year has been of major strategic importance to Proteome Sciences, having seen the business transform into a position of global leadership in applied proteomics and achieved our first commercialisation deal followed by a second early in the current year. This endorses our strategy of concentrating on proteins and protein modification in disease. 'The importance and value of proteins in biomedical research have been greatly increased since the sequencing of the human genome in 2001 and for Proteome Sciences this has been further enhanced by the unique ProteoSHOPTM toolbox that has been developed. This gives us a considerable advantage and an outstanding opportunity to capitalise on the discovery of high value protein biomarkers with our partners that will accelerate the development of diagnostic, prognostic and therapeutic applications. 'We are well funded with a low and predictable rate of cash burn and do not envisage any major capital expenditure for the foreseeable future. The prospects for the ProteoSHOPTM proteomics technology, its application in human diseases and the commercial potential across the Group look increasingly attractive.' ENDS Attached: Full text of preliminary statement, unaudited consolidated profit and loss account and notes to the financial information. For further information please contact: Proteome Sciences plc Tel: +44 (0)1932 865065 www.proteome.co.uk Email: christopher.pearce@proteome.co.uk Christopher Pearce, Chief Executive Public Relations for Proteome Sciences Tel: +44 (0)1483 535102 IKON Associates Mobile: +44 (0)797 9900733 Adrian Shaw Email: adrian@ikonassociates.com Notes to Editors: Proteome Sciences plc applies high sensitivity proteomics to identify and characterise differential protein expression in diseases for diagnostic, prognostic and therapeutic applications. It has to date developed sensitive blood assays for stroke, nvCJD, BSE and solid organ transplant rejection. The main focus of its research currently addresses neurological, neurodegenerative, diabetes/obesity, oncology and cardiovascular conditions. Commercialisation of these programmes will be effected through strategic alliances and licensing agreements. Proteome Sciences is headquartered in Cobham, Surrey in the UK and has laboratories at Kings College Hospital, London and in Frankfurt. It employs 40 full time scientists in addition to its corporate and business development staff. The Company has been listed on the Alternative Investment Market since 1994. Dear Shareholder, I am delighted to report that the year under review has been a most significant one for your company and has witnessed the conclusion of the transformation of Proteome Sciences plc from a virtual company, prior to the sequencing of the human genome in 2001, to a global leadership position in 2003 in applied proteomics for human diseases. This process was largely completed following the acquisition and integration of the proteomics activities of Aventis Research and Technologies GmbH & Co KG (Aventis R&T) with our facilities in London in the third quarter of 2002. Over the same period, we have established a strong business development team which has already successfully concluded the commercialisation of two of the first products to be developed from applied proteomics - biomarkers in blood to be used in a rapid test to detect stroke in humans and for BSE from blood samples in live cattle. The transition that has taken place clearly endorses Proteome Sciences' strategy of concentrating on proteins and protein modifications in disease, rather than following the conventional approach pursued by the great majority of life sciences research in genomics. Proteomics The technology comprising proteomics is multi-disciplined and has been largely concentrated and developed by specialist teams in academia rather than from a commercial background. The range and high levels of expertise necessary to deal with the extreme complexity of human diseases need to be combined and integrated with new methods of data capture, analysis and pattern recognition. Following the sequencing of the human genome in 2001, Proteome Sciences has been particularly successful in putting together a unique toolbox to address differential protein expression in diseases. This has been drawn from the strong scientific foundations established through its long standing collaborative agreements in human biology and protein separation with academia and more recently through the acquisition of the specialist chemistry, computer sciences and bioinformatics capabilities in Frankfurt. As a consequence, Proteome Sciences not only has access and expertise across the key segments of these disparate skills but also has assembled a range of proprietary and next generation technologies (PST(R), TMT(R), PSS(R), ProteoPrep (R), Sensitizer(R)) which provide it with considerable advantages in addressing the requirements of pharmaceutical, biotechnology and diagnostics companies, in crucial applications, and in particular in the area of membrane proteins. These are the high value targets for drug discovery and development where existing technology is currently not particularly effective. Proteome Sciences combines high sensitivity capability with high throughput. The Proteome Sciences toolbox ProteoSHOPTM is being applied across a large number of human diseases including neurology, neurodegeneration, cardiovascular, cancer and diabetes/obesity to identify novel disease biomarkers. The principle applications are for: • Diagnostic Markers • Prognostic Markers • Membrane Proteins • Therapeutic Targets • Drug Validation These are being commercially exploited through licensing agreements, funded research and strategic research alliances. Commercialisation The last twelve months have seen major activity in the Business Development Department and the Company signed its first exclusive licensing agreement for its stroke biomarkers with Biosite Inc, a world leader in point of care diagnostics, in December 2002. This collaboration is proceeding extremely well and Biosite are further validating and developing these markers for use in their desktop Triage(R) point of care test. The information generated in developing these markers will be used by Proteome Sciences to attract other licensees for the high throughput clinical laboratory market which currently accounts for approximately 90% of global diagnostic sales. Discussions are taking place with interested parties and further commercialisation of Proteome Sciences' stroke markers in other applications is anticipated over the next 12 months. A second licensing deal was announced at the beginning of April 2003, with IDEXX Laboratories Inc., a world leader in veterinary diagnostic products, granting exclusive global rights for Proteome Sciences' BSE biomarkers in live cattle and Transmissible Spongiform Encephalopathies (TSEs) in other animals. Like Biosite, IDEXX will develop these markers further and intend using them in a blood assay to detect BSE in live cattle and TSEs in other animals. The only tests currently available for BSE are post-mortem tests. It is anticipated that the market for live animal testing will be considerably larger as routine screening of cattle herds becomes possible for the first time. This will address a major unmet need in veterinary diagnostics. The EU cattle population totalled 80 million in 2001. The BSE market for post mortem testing of cattle was €105m, with the EU paying €15 for each test kit. Experts estimate that the demand could grow to 30 million tests in the EU, projecting a future market size of €450m. These figures exclude any demand from the USA, which has an estimated 100 million cattle population. Proteome Sciences continues to progress its research programme in human TSEs (CJD and vCJD), and at the Siena Proteomics Society meeting in September, data relating to new CSF and serum markers for the diagnosis of CJD and vCJD was presented which showed 100% sensitivity and specificity in CSF. The recent receipt of additional samples will accelerate the development and further validation of these markers. Further licensing agreements from the TSE programme are envisaged in due course for blood transfusion screening and diagnosis of CJD and vCJD. In solid organ transplant rejection, Proteome Sciences' biomarkers for detecting acute and chronic rejection have attracted considerable interest and the Company is in active discussions to out-license these to commercial partners. In addition to biomarkers, Proteome Sciences has novel proprietary technologies which fall under the ProteoSHOPTM brand - 'Proteome Sciences High Output Proteomics'. Included in this is our automated, high throughput 2DE capability, together with PSS(R) the spot detection and image analysis display system and ProteoPrep(R) the sample preparation methodology. Our PST(R) and TMT(R) technologies (gel free protein sequence tags) were launched at major biotechnology meetings in San Diego, USA and in Lyon, France in April 2003 and will be presented at BIO 2003 in Washington. These have generated considerable commercial interest and we expect to start entering into strategic research and development alliances using this powerful technology to exploit the opportunities in membrane and membrane associated proteins later in the year. From our research activities, we have identified a number of proprietary technologies which can be commercialised through out-licensing. Sensitizer(R) is a novel chemical reagent that can enhance the sensitivity of mass spectrometers up to 100 fold for the identification of proteins and biomarkers. Sensitizer(R) both dramatically increases the number of proteins detected in a cost effective manner and provides users of mass spectrometry equipment with the ability to significantly increase the quantity and quality of data produced. This is particularly important as mass spectrometry is central to modern proteomics and is utilised in high volume/high throughput applications. Having announced Sensitizer(R) in March to the trade, Proteome Sciences intends to conclude a license agreement in the second half of 2003. Intronn Inc. Intronn has been involved in a most active period both in terms of its science and its corporate development. The SMaRT(R) technology featured on the front cover of Nature Biotechnology at the start of the year having successfully corrected the cystic fibrosis gene defect in a human cell model in a paper published by Dr. John Engelhardt (University of Iowa). In June, mutant Factor VIII (haemophilia) RNA was successfully repaired using SMaRT(R) transplicing by Dr. Christopher Walsh, University of North Carolina. The National Institute of Health (NIH), USA recently awarded a $605,791 grant to take the Factor VIII programme to the final stages of pre-clinical testing. Approximately 80 per cent of haemophilia patients who suffer from mutations in the Factor VIII gene can potentially be corrected by SMaRT(R) technology. SMaRT (R) is also now being used in novel applications for molecular imaging in diagnostics and drug development. Intronn Inc. was also awarded a US $434,000 grant by the National Cancer Institute, USA, for its research in molecular imaging, and this will open up a new range of substantial commercial opportunities and applications for SMaRT(R). ProBioGen Inc. entered into a research collaboration with Intronn Inc. to use SMaRT(R) in its cell line development programme. Further scientific results were presented from the main research programmes by Intronn's principal academic collaborators at the recent American Society of Gene Therapy meeting. In March 2002, Intronn relocated to temporary incubator space in Rockville, Maryland and subsequently moved into purpose built facilities in Gaithersburg, Maryland in March 2003. A number of key appointments have been made including Dr. Ed Otto as Chief Operating Officer (formerly COO at Genetic Therapy Inc., a subsidiary of Novartis), Diane Greene, Vice President of Business Development (formerly Director of Marketing, Celera Genomics) Dr. Gary Temple, Director of Cancer Biology (formerly Invitrogen Inc.) and Nancy Streicher as Corporate Controller. The key hires have now been completed and the total headcount stands at 26. Over the last year, Intronn has assembled and expanded the management, premises and scientific staff at Gaithersburg, USA with an initial focus on the core applications and advantages of SMaRT(R) in key areas of commercial interest. Intronn is now well positioned to exploit the significant opportunities afforded by the SMaRT(R) technology platform. Veri-Q Inc Veri-Q concluded a licensing agreement in July 2002 with North Carolina State University in respect of the results, data and intellectual property of the research relating to the levels of impurity in synthetic oligonucleotides, and patents have been filed on the antibodies against the protecting/de-protecting groups for applications in antisense therapeutics and oligonucleotide diagnostics. Papers have been published in Analytical Biochemistry and Nature Biotechnology, which revealed that 31% of commercial DNA products from eight different suppliers had impurities because the protecting groups had not been fully removed. This proves costly and unsatisfactory for the users of synthetic oligonucleotides. Veri-Q is in the process of out-licensing the technology for applications in RNA, RNAi, DNA, chip technology and quality control in synthetic oligonucleotide production and reagents. Commercialisation is expected later this year. Results In the twelve month period ended 31st December 2002, Proteome Sciences incurred a loss on ordinary activities after taxation of £4,109,586 (2001: £2,003,152). At the year end, cash and cash held on deposit stood at £4,255,750. Costs relating to the acquisition of the Aventis proteomics activities totalled £281,338. In addition, the Company has today raised £5.863 million by a placing of 4,805,766 new ordinary shares of 1 pence each at a price of 122 pence per share with institutional investors. The new ordinary shares represented 5% of the Company's share capital prior to their issue and were issued under the authority granted by shareholders at last year's Annual General Meeting. Current Outlook Proteome Sciences has established a global leadership position in applied proteomics, in particular through the unique ProteoSHOPTM tool box that has been developed. This includes PST(R) and TMT(R) technology which offer a highly effective and novel solution to address membrane proteins, one of the main targets and the high value area for the pharmaceutical industry. Out-licensing of the blood biomarkers for stroke and BSE have already taken place but further commercialisation will be undertaken for the same diseases in different applications in high throughput testing and blood screening. There will be a strong news flow from other disease programmes at Proteome Sciences in respect of out-licensing through funded research, strategic alliances in membrane proteins and using the ProteoSHOPTM tool box. In addition, some proprietary technology will be out-licensed including Sensitizer(R) reagents and Veri-Q antibodies where there will be high volume/high margin utilisation and which will not undermine the technical advantages that have been established in our proprietary proteomics platform. These should also provide a strong cash flow contribution. From a financial perspective, the commercialisation process will have a significant effect on the business, moving into revenue in the current year and then generating both revenue and royalties in 2004. This will be made up from a combination of out-licences with upfront payments and milestones, funded research, strategic alliances, grants and proprietary technology income from Sensitizer(R) and Veri-Q. At the same time, the Company continues to have a low and predictable rate of cash burn and does not envisage any major capital expenditure for the foreseeable future. The importance and value of proteins in biomedical research have been greatly increased since the sequencing of the human genome in 2001 and for Proteome Sciences this has been further enhanced by the unique ProteoSHOPTM tool box that has been developed. This gives us a considerable advantage and an outstanding opportunity to capitalise on the discovery of high value protein biomarkers with our partners that will accelerate the development of diagnostic, prognostic and therapeutic applications. The prospects for the ProteoSHOPTM proteomics technology, its application in human diseases and the commercial potential across the Group look increasingly attractive. I would like to take this opportunity to thank all our employees, both in the UK and overseas, and our collaborators for their hard work and commitment to the progress at Proteome Sciences over the period, and to welcome Dr. Sandra Steiner to the Company, the former Executive Vice President at Large Scale Biology Corporation, Germantown, USA who was recently appointed as Research and Development Director and completes our executive management team. Steve Harris Chairman 26th June 2003 2002 2001 £ £ Turnover Existing operations 100,057 - Acquisitions 71,344 - __________ __________ 171,401 - Cost of sales (131,753) - __________ __________ Gross Profit 39,648 - Other operating expenses (4,237,832) (2,110,648) __________ __________ Operating loss (4,198,184) (2,110,648) __________ __________ Existing operations (2,870,701) (2,028,489) Acquisitions (1,327,483) - __________ __________ Continuing operations (4,198,184) (2,028,489) Discontinued operations - (82,159) __________ __________ (4,198,184) (2,110,648) Share of associate's operating loss (322,128) (33,774) Interest receivable 85,259 104,197 Interest payable and similar charges (11,018) (32,846) __________ __________ Loss on ordinary activities before taxation (4,446,071) (2,073,071) Tax on loss on ordinary activities 336,485 69,919 __________ __________ Loss on ordinary activities after taxation (4,109,586) (2,003,152) Equity minority interest - 26,128 __________ __________ Loss for the financial year (4,109,586) (1,977,024) __________ __________ Loss per share Basic and diluted (3.96p) (2.16p) __________ __________ 2002 2001 £ £ Fixed assets Goodwill 6,165,121 - Tangible assets 1,503,311 671,067 Associates 949,863 1,415,638 Other investments 225,756 225,756 __________ __________ 8,844,051 2,312,461 __________ __________ Current assets Debtors 725,225 374,161 Cash held on deposit as short term investment 3,349,255 800,000 Cash at bank and in hand 906,495 261,024 __________ __________ 4,980,975 1,435,185 __________ __________ Creditors: Amounts falling due within one year, including (1,840,698) convertible debt (1,074,539) __________ __________ Net current assets 3,140,277 360,646 __________ __________ Total assets less current liabilities 11,984,328 2,673,107 Creditors: Amounts falling due after more than one year (143,430) (163,173) __________ __________ Net assets 11,840,898 2,509,934 __________ __________ Capital and reserves Called-up share capital 1,141,153 915,384 Share premium account 15,516,629 12,945,904 Other reserves 10,755,000 - Profit and loss account (15,571,884) (11,359,442) Equity minority interests - 8,088 __________ __________ Equity shareholders' funds 11,840,898 2,509,934 __________ __________ 2002 2001 £ £ Net cash outflow from operating activities (3,494,131) (1,624,406) Returns on investments and servicing of finance 74,241 71,351 Taxation 146,485 Capital expenditure and financial investment (47,546) (473,469) Acquisitions and disposals 3,637,730 (78,569) __________ __________ Cash outflow before financing 316,779 (2,105,093) Management of liquid resources (2,549,255) 2,000,000 Financing 2,581,467 (52,417) __________ __________ Increase/(decrease) in cash in the year 348,991 (157,510) __________ __________ Reconciliation of operating loss to operating cash flows 2002 2001 £ £ Operating loss (4,198,184) (2,110,648) Depreciation charges 369,845 103,093 Amortisation charges 324,480 - Profit on sale of tangible fixed assets (331) (9,079) (Increase)/decrease in debtors (79,545) 37,444 Increase in creditors 89,604 354,784 __________ __________ Net cash outflow from operating activities (3,494,131) (1,624,406) __________ __________ 1. There has been no change to any of the accounting policies set out in the 2001 statutory accounts, except that the Group policy for accounting for deferred tax has changed to comply with FRS 19 'Deferred Tax'. 2. Following the loss of £4,109,586 incurred in the period, the Directors do not recommend the payment of a dividend. 3. a. The calculation of the loss per share for the year ended 31st December 2002 is based on the loss for the year of £4,109,586 and on 103,672,012 Ordinary Shares, being the weighted average number of shares in issue and ranking for dividend during the year. b. The calculation of the loss per share for the year ended 31st December 2001 is based on the loss for the year of £1,977,024 and on 91,538,400 Ordinary Shares, being the weighted average number of shares in issue and ranking for dividend during the year. 4. The preceding financial information does not constitute statutory accounts as defined in Section 240 of the Companies Act 1985. The financial information for the year to 31st December 2001 is based on the statutory accounts for that year. These accounts, upon which the auditors issued an unqualified opinion, and which did not contain any statement under Section 237(2) or (3) of the Companies Act 1985, have been delivered to the Registrar of Companies. The statutory accounts for the year ended 31st December 2002 will be finalised on the basis of the financial information presented by the Directors in this preliminary announcement and will be posted to shareholders this month. After that time they will also be available at the Company's registered office: Coveham House, Downside Bridge Road, Cobham, Surrey KT11 3EP. This information is provided by RNS The company news service from the London Stock Exchange
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