Interim Results - 6 Months to 31 March 2000

Cambridge Antibody Tech Group PLC 22 May 2000 For Further Information Contact: Cambridge Antibody Technology Tel: +44 (0) 1763 263233 Dr David Chiswell, Chief Executive Officer John Aston, Finance Director Rowena Gardner, Communications Manager HCC De Facto (Europe) Tel: +44 (0) 20 7496 3300 Nikul Odedra (trade) Sue Charles (city/financial) BMC Communications/The Trout Group (USA) Tel: +1 212 477 9007 Brad Miles, ext 17 (media) Jonathan Fassberg, ext.16 (investors) CAMBRIDGE ANTIBODY TECHNOLOGY INTERIM RESULTS FOR THE SIX MONTHS ENDED 31 MARCH 2000 Highlights Wide ranging strategic alliance signed with Searle in December 1999 Broadening of the partnership with Human Genome Sciences - a major alliance, including co-development rights, signed in February 2000, just six months after the initial collaboration Phase III clinical trials initiated by BASF Pharma for D2E7, a human anti-TNFa monoclonal antibody for rheumatoid arthritis, isolated and optimised by CAT in collaboration with BASF Pharma Good phase I/IIa one-year results for CAT-152, a human monoclonal antibody against TGFb2, now in phase II clinical trials as a potential treatment to prevent post-operative scarring in patients undergoing surgery for glaucoma A new programme - CAT-213, an anti-eotaxin human monoclonal antibody, has entered pre-clinical development as a potential treatment for allergic disorders Loss for the six months ended 31 March 2000 of £2.1 million Successful equity financing completed in April, raising £93m before expenses Pro-forma cash and liquid resources at 31 March 2000 (adjusted for proceeds of equity financing and HGS subscription): £160.7 million Professor Peter Garland, Chairman of Cambridge Antibody Technology, commented: 'In the first six months of the year CAT has achieved significant commercial and clinical milestones, and substantially strengthened its financial position, providing a strong platform on which to achieve future growth.' CAMBRIDGE ANTIBODY TECHNOLOGY INTERIM RESULTS FOR THE SIX MONTHS ENDED 31 MARCH 2000 OVERVIEW The six months to the end of March 2000 has been one of the most rewarding and exciting for the company. During the period CAT completed two significant strategic alliances - with Searle and Human Genome Sciences (HGS), both of which demonstrated the value relationship between platform technologies and the clinical potential of monoclonal antibodies as therapeutic products. Importantly, the HGS alliance gives CAT the opportunity to develop antibody-based drugs against genomics-derived drug targets from HGS. Clinical product development programmes continued to make good progress. The lead programme, D2E7, isolated and optimised by CAT in collaboration with BASF Pharma and now being developed by BASF Pharma, entered phase III clinical trials for rheumatoid arthritis. During the period CAT-192 completed phase I patient recruitment and, immediately post year-end, good phase I/IIa one-year results for CAT-152, a potential treatment to prevent post-operative scarring in the eye, were announced. Looking to the future, CAT has begun a new programme with potential for use in allergic disorders with CAT-213, an anti-eotaxin antibody, entering pre-clinical development. During the period, the company has substantially strengthened its financial base, including raising £93m before expenses from an equity fundraising. The company is now well positioned, in terms of its financial base, its technology platform and its clinical programmes, to achieve significant growth in the future. STRATEGIC ALLIANCES In December 1999 CAT announced a multidisciplinary strategic alliance with Searle, the pharmaceutical business of Monsanto Company, for the development of fully human monoclonal antibody-based therapeutic drugs across multiple disease areas, focusing particularly on the field of cancer. This was CATs largest alliance to date with a headline potential deal size in excess of US$212 million: Searle invested US$12.5 million in new CAT ordinary shares; US$14.5 million was committed over three years in research funding; CAT could receive up to a further US$35 million in license fees, research funding and technical performance milestones over the potential five-year term of the research collaboration. There is potential to receive an additional US$150 million in clinical development and regulatory approval milestones as well as further future revenue from product royalties. This deal was followed in March 2000 by the announcement of a major alliance with HGS, dedicated to developing human antibody therapeutics against genomics-derived disease targets. This represented a significant broadening of CAT's relationship with HGS, coming just six months after the initial collaboration. It included the equivalent of US$67 million in up front funding for CAT - US$55 million being invested in equity, and US$12 million being committed in licensing and research support fees. This alliance provides the potential for CAT and HGS to generate a substantial pipeline of human antibody drugs and gives CAT greater opportunity to aggressively develop and commercialise its own antibody-based pipeline of drugs. PRODUCT PIPELINE During the six months there has also been significant progress in CAT's clinical pipeline. D2E7 (a fully human monoclonal antibody that neutralises TNFa) made positive progress in the period as a treatment for rheumatoid arthritis. In February BASF Pharma announced that it had initiated phase III trials of D2E7 and further phase II clinical data are to be presented at the European League of Rheumatology meeting (EULAR) in June 2000. D2E7 is the first fully human monoclonal antibody to enter phase III clinical trials. Taken together with the three other human monoclonal antibodies developed with CATs technology also in clinical trials, this development underlines CATs technology as the leading technology platform in the development of fully human monoclonal antibodies as drugs. CAT-152 (a fully human monoclonal antibody against TGFb2) is being developed by CAT as a treatment to prevent post-operative scarring in patients undergoing surgery for glaucoma. In May 2000 the one year results from the Phase I/IIa clinical trial of CAT-152 were announced at the Annual Meeting of the Association for Research in Vision and Opthalmology (ARVO). Treatment with CAT-152 was associated with encouraging trends for a reduced need for intervention and topical treatment and also with a lower intraocular pressure which could represent evidence of clinically relevant anti-scarring activity, albeit based on low patient numbers. The patients in this trial are being followed for a further year. Recruitment to the phase II study, which commenced in October 1999, is underway and should be complete by the end of 2000. Further trials are expected to commence in early 2001. J695 is a fully human monoclonal antibody that neutralises Interleukin 12 (a pro-inflammatory molecule associated with many severe autoimmune disorders) and continues to progress in clinical development, having entered Phase I clinical trials, conducted by BASF Pharma and Genetics Institute (Wyeth-Ayerst), in June 1999. CAT-192 is a fully human anti-TGFb1 monoclonal antibody that is being developed by CAT as a potential treatment in a range of scarring and fibrotic conditions. CAT-192 entered phase I clinical trials in November 1999. Recruitment and dosing in this phase I study have been completed. Results show that CAT-192 appears well tolerated, with a prolonged half-life of around 40 days in healthy volunteers. Following these phase I results, the immediate focus is on systemic injection/disorders. The development programme is on schedule for patient studies later this year. CAT-213, a fully human anti-eotaxin monoclonal antibody with potential in the treatment of allergic disorders, has moved into pre-clinical development. INTELLECTUAL PROPERTY During the period CAT has further extended its patent estate in the US with the granting of a key patent covering its ProxiMol technology. FINANCING AND OPERATIONS CAT announced an equity fundraising in March aimed at raising £100 million. The purpose of the fundraising was to finance CATs continuing operations and to allow an expansion and acceleration of CATs own development activities. The offering was structured to allow the marketing of shares to international investors in the United States and continental Europe. In difficult market conditions the offering was successfully concluded, albeit that the amount raised was reduced from the original target of £100 million to £93 million (before expenses). The Company thanks existing shareholders for their continued support and commitment and welcomes its new shareholders. These additional funds will enable the Company to capitalise on its market leading position, in particular to allow CAT to capture more value by expanding activities, increasing the breadth of its product pipeline and gaining greater flexibility in the partnering of programmes. Following the success of this financing, CAT intends to seek a secondary listing on the US NASDAQ at the appropriate time. The Company employed 153 staff as at 31 March 2000. Further recruitment is underway. The intention is to build staff numbers to approximately 250, with the greater part of the increase in the next 18 months. FINANCIAL RESULTS Net cash inflow before financing for the six months ended 31 March 2000 was £4.9 million (six months ended 31 March 1999 (H1) outflow £7.7 million; six months ended 30 September 1999 (H2) £4.1 million outflow). CAT made a loss for the period of £2.1 million (1999: H1 £6.5 million; H2 £6.2 million). Cash and liquid resources at 31 March 2000 amounted to £36.5 million (31 March 1999 £27.4 million; 30 September 1999 £23.6 million). Subsequent to the period end, on 1 April 2000, the Company issued 1,670,000 shares to HGS for £34.7 million in cash, in connection with a collaboration agreement. In early April, on completion of the equity fund raising referred to above, 5,010,532 shares were issued to raise £89.5 million net of expenses. Revenues in the period were £6.4 million (1999: H1 none, H2 £1.8 million). The profile of revenues is irregular due to the nature of CAT's business although latterly some collaborations are providing a more regular source of income. During the period a milestone was received from BASF in relation to commencement of Phase III trials for D2E7 and significant income generated from ongoing collaborations with HGS, Wyeth-Ayerst and Searle. Of monies received during the period from Searle and HGS, a considerable proportion relates to services to be provided in future periods. Such income has been deferred and will be recognised as the services are provided. Operating costs for the period amounted to £8.1 million (1999: H1 £7.6 million; H2 £8.7 million). Operating costs have fluctuated with the incidence of external development expenditure and staff costs have shown modest increases in line with staff numbers. In addition there was an exceptional charge in the period of £0.9 million (comparative periods: nil) which is a provision for employers National Insurance on certain options granted in December 1999. In December 1999 56,000 shares were placed to fund the payment of a liability otherwise payable by the issue of shares. In January 2000 the Company issued 1,870,837 shares to Monsanto Europe SA for cash of £7.8 million, in connection with a collaboration agreement. Further shares have been issued during the period on exercise of share options. Whilst operating expenses and capital expenditure over the six months were broadly in line with expectations, the incidence of significant cash receipts, particularly from Searle and HGS resulted in a net cash inflow for the period. Over the second half of the year operating expenditure is expected to rise as the scale of activity is increased. Investment income will be significantly higher, reflecting the increased level of cash and liquid resources. CAMBRIDGE ANTIBODY TECHNOLOGY Consolidated profit and loss account (Unaudited) 6mths end 6mths end Yr end 31 March 31 March 30 Sept 2000 1999 1999 £'000 £'000 £'000 Turnover 6,388 - 1,799 Direct costs (249) - (81) Gross profit 6,139 - 1,718 Research and development expenses (6,642) 6,331) (13,574) General and administration expenses (1,462) (1,242) (2,684) National Insurance on share options (885) - - Operating loss (2,850) (7,573) (14,540) Interest receivable (net) 749 1,109 1,810 Loss on ordinary activities before taxation (2,101) 6,464) (12,730) Taxation on loss on ordinary activities - - (1) Loss for the financial period (2,101) (6,464) (12,731) Loss per share - basic and fully diluted (pence) 8.0 27.1 52.4 Consolidated statement of total recognised gains and losses 6mths end 6mths end Yr end 31 March 31 March 30 Sept 2000 1999 1999 £'000 £'000 £'000 Loss for the financial period (2,101) (6,464) (12,731) Loss on foreign exchange translation - (1) (1) Total recognised loss (2,101) (6,465) (12,732) CAMBRIDGE ANTIBODY TECHNOLOGY Consolidated balance sheet (Unaudited) As at 31 As at 31 As at 30 Mar Mar Sept 2000 1999 1999 £000 £000 £000 Fixed Assets Intangible assets 4,635 5,358 4,822 Tangible fixed assets 5,194 5,987 5,837 9,829 11,345 10,659 Current Assets Debtors 1,555 1,525 894 Investment in liquid resources 36,286 26,858 22,773 Cash at bank and in hand 206 512 849 38,047 28,895 24,516 Creditors Amounts falling due within one year (6,687) (2,065) (3,275) Net current assets 31,360 26,830 21,241 Total assets less current liabilities 41,189 38,175 31,900 Creditors Amounts falling due after more than one year (3,441) - - Net Assets 37,748 38,175 31,900 Capital and Reserves Called-up share capital 2,759 2,398 2,528 Share premium account 56,071 45,969 48,465 Other reserve 13,451 13,339 13,339 Shares to be issued - 2,634 - Profit and loss account (34,533) (26,165) (32,432) Shareholders' funds - all equity 37,748 38,175 31,900 CAMBRIDGE ANTIBODY TECHNOLOGY Consolidated cash flow statement (Unaudited) 6mths end 6mths end Yr end 31 March 31 March 30 Sept 2000 1999 1999 £'000 £'000 £'000 Operating loss (2,850) (7,573) (14,540) Depreciation in the period 907 727 1,627 Amortisation of patents 187 202 389 Profit on disposal of fixed assets (6) - - (Increase) / decrease in debtors (558) 143 264 Increase / (decrease) in creditors 6,858 (144) 1,072 Net cash inflow / (outflow) from operations 4,538 6,645) (11,188) Returns on investments and servicing of finance Interest received 646 891 2,102 Interest paid - (1) (2) 646 890 2,100 Taxation Overseas taxation paid - - (1) Capital expenditure and financial investment Purchase of fixed assets (289) (1,922) (2,672) Sale of fixed assets 31 - - (258) (1,922) (2,672) Net cash inflow / (outflow) before management of liquid resources and financing 4,926 (7,677) (11,761) Management of liquid resources (13,513) 7,966 12,051 Financing Issue of ordinary shares 7,949 198 539 Capital element of finance lease payments (9) (2) (4) 7,940 196 535 (Decrease) / increase in cash and cash equivalents (647) 485 825 Notes Basis of preparation These interim financial statements have been prepared in accordance with the policies set out in statutory financial statements for the year ended 30 September 1999. These interim financial statements do not constitute statutory financial statements within the meaning of section 240 of the Companies Act 1985. Results for the six-month periods ended 31 March 2000 and 31 March 1999 have not been audited. The results for the year ended 30 September 1999 have been extracted from the statutory financial statements, which have been filed with the Registrar of Companies and upon which the auditors reported without qualification. National Insurance on share options There was an exceptional charge in the period of £0.9 million (comparative periods: nil) which is a provision for employers National Insurance on certain options granted in December 1999. The provision is based on the share price of the company at the period end and current National Insurance rates and its size reflects the significant increase in the share price since the date of grant. The liability will not crystallise until the options are exercised (they are exercisable from December 2002) and the ultimate liability will be determined by the market price on exercise. As the share price at future period ends fluctuates so the liability will fluctuate, giving rise to further charges or to credits to the profit and loss account in those periods. A change of 10% in the share price (based on that at the current period end) would cause the liability to fluctuate by approximately £103,000. Loss per share The loss per ordinary share and fully diluted loss per share are equal because the Group is sustaining losses. The calculation is based on the following, for the six months ended 31 March 2000, the six months ended 31 March 1999 and the year ended 30 September 1999 respectively. Losses of £2,101,000, £6,464,000, and £12,731,000. Weighted average number of shares in issue of 26,285,300, 23,828,470, and 24,314,191. The company currently has 34,275,039 ordinary shares in issue and a total of 2,295,033 ordinary shares under option. Creditors The Groups creditors have increased sharply during the period. This reflects the significant amounts of income deferred to future periods, the provision for National Insurance on certain share options and provision for non-contingent expenses of the Offers incurred up to 31 March 2000. Notes Cambridge Antibody Technology (LSE:CAT) CAT is a UK biotechnology company using its proprietary technologies in fully human monoclonal antibodies for drug discovery and drug development. Based in Melbourn, 10 miles south of Cambridge, England, CAT currently employs around 150 people. CAT is listed on the London Stock Exchange, having raised £41m in its IPO in March 1997. An Open Offer and International Offering in March 2000 raised £93m. CAT has a world-leading platform technology for rapidly isolating fully human monoclonal antibodies using phage display systems. CAT has an extensive phage display antibody library, currently incorporating around 100 billion distinct antibodies. This library forms the basis for the companys strategy to develop a portfolio of clinical development programmes and for discovering new drug leads using functional genomics. Four fully human therapeutic antibodies developed by CAT are at various stages of clinical trials. CAT has a number of license and collaborative agreements in place with pharmaceutical and biotechnology companies including: Eli Lilly, Pfizer, BASF Pharma, Genentech, ICOS Corporation, Genetics Institute, Wyeth-Ayerst, Human Genome Sciences, AstraZeneca and Searle.
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