British Biotech plc: Preliminary Financial Results for the Year Ended April 30, 2002.Business Editors British Biotech British Biotech was a British based biotech company. British Biotechnology Limited was founded in 1986 by former G D Searle managers Keith McCullagh and Brian Richards, [1] plc (Nasdaq:BBIOY)(LSE LSE - Language Sensitive Editor :BBG BBG Brooklyn Botanic Garden BBG Broadcasting Board of Governors BBG Bloomberg (financial company) BBG Bundesbeamtengesetz (German Law) BBG Bergbau-Berufsgenossenschaft (Germany) ) today announced its preliminary financial results for the year ended April 30, 2002. Business highlights
-- BB-10901
-- Phase I/II study under way in relapsed/refractory small
cell lung cancer (weekly dosing)
-- CTX granted for UK Phase I study
-- E21R
-- Phase II study stopped in acute myeloid leukemia
-- Phase II study continuing in chronic myelomonocytic
leukemia
-- Orphan drug designation for juvenile myelomonocytic
leukemia (EU)
-- BB-10153
-- Successful manufacturing campaign
-- Phase II proof-of-principle study in acute myocardial
infarction to start July 2002
-- Product Portfolio expanded with the grant of European
development and commercialization rights to MG98 from
MethylGene Inc.
-- Antibiotic Program
-- BB-83698 to start Phase I by October 2002
-- Nine presentations at 41st ICAAC (December 2001); eight
presentations accepted for 42nd ICAAC (September 2002)
-- Biodefense research agreement with UK Government's Defense
Science and Technology Laboratory
-- Batimastat BiodivYsio(R) stent
-- Development suspended
-- Final stage of restructuring completed with the sale of
non-core assets to OSI Pharmaceuticals, Inc., and the
successful recruitment of experienced pharmaceutical industry
executives into key operational roles
Financial highlights -- Loss for the year reduced to (pound)16.9 million (US$24.7 million) (2001: (pound)23.4 million) -- Annual cash burn of (pound)14.6 million (US$21.3 million) (2001: (pound)10.7 million) -- Cash and short term investments of (pound)50.4 million (US$73.6 million) at April 30, 2002 Commenting on the year's results, Dr Elliot Goldstein, Chief Executive Officer of British Biotech, said: "In a challenging economic environment for biotechnology companies Top 100 Biotechnology Companies The following is a list of the top 100 biotechnology companies ranked by revenue. The first nine companies qualify for the list of the top 50 pharmaceutical companies. , British Biotech continues to make progress. With products in the clinic, strong development capabilities and cash, British Biotech is well placed for strategic initiatives in Europe and North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. that will strengthen our platform for growth and the creation of shareholder value." This news release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. that reflect the Company's current expectation regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategy, the applicability of the discoveries made therein, the successful and timely completion of clinical studies and the uncertainties related to the regulatory process. British Biotech plc ("British Biotech") Preliminary results for the year ended April 30, 2002 1. Business Review Company Strategy British Biotech's strategy is to create long-term value for shareholders by building a product portfolio of innovative medicines, targeted mainly at cancer but based on a variety of technologies, and to bring these to market as expeditiously ex·pe·di·tious adj. Acting or done with speed and efficiency. See Synonyms at fast1. ex as possible. The Company has retained commercialization rights, in various territories, to all of the products in the portfolio and value will be created as the Company generates data from later-stage clinical trials over the next three years. The Company adopts a highly rigorous approach to its development activities. Should any product fail to meet its clinical endpoints, development will cease and it will be dropped from the portfolio. The portfolio will continue to be expanded by drug development candidates emerging from in-house research and by the acquisition of rights to products discovered by other companies. The Company is actively seeking further collaborations where it can apply its development capabilities to create additional value. Additionally, the Board is looking at ways in which the Company can enhance shareholder value by combining its own portfolio, development capabilities and cash with those of other businesses in Europe and North America. Restructuring In August 2001 British Biotech completed the final stage in its restructuring program, enabling it to intensify its focus on drug development, add to cash resources, and reduce significantly its fixed infrastructure costs. Under an agreement with OSI Pharmaceuticals OSI Pharmaceuticals, Inc. is an American pharmaceutical company based in Long Island, New York with facilities in Colorado, New Jersey and the United Kingdom. They specialize in the discovery and development of molecular targeted therapies, and are listed in the NASDAQ , Inc., (NASDAQ: OSIP OSIP Open Source Integrated Portfolio OSIP Open Sip (session initiation protocol) OSIP Ohio Statewide Imagery Program OSIP Operational Safety Improvement Program OSIP Operational Suitability Improvement Program (aviation) ), British Biotech transferred part of its pre-clinical research facilities to OSI (1) (Open System Interconnection) An ISO standard for worldwide communications that defines a framework for implementing protocols in seven layers. Control is passed from one layer to the next, starting at the application layer in one station, proceeding to the , including 59 employees, leases on two properties, and fixed assets fixed assets npl → activo sg fijo fixed assets npl → immobilisations fpl fixed assets fix npl → with a net book value of (pound)5.0 million (US$7.3 million). British Biotech received (pound)8.7 million (US$12.7 million) in cash and reduced the Company's fixed infrastructure costs by (pound)6.0 million (US$8.8 million) per annum Per annum Yearly. . Following the restructuring, British Biotech had 87 full-time employees at April 30, 2002. People In line with its focus on products, British Biotech has sought to strengthen its development capabilities, and has been successful in recruiting experienced executives from established pharmaceutical companies such as Pfizer, Glaxo SmithKline, Novartis and Johnson & Johnson to key managerial and operational roles in clinical development, business development and regulatory affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: Product Portfolio British Biotech's Product Portfolio currently comprises four drugs in clinical development and one product in late-stage pre-clinical development Pre-clinical development is a stage in the development of a new drug that begins before clinical trials (testing in humans) can begin, and during which important safety and pharmacology data is collected. .
----------- --------------- ------------------- ---------- -----------
Product/ Indications Clinical Commercial Next
Partner Development Rights Milestones
Status
=========== =============== =================== ========== ===========
BB-10901 - Small cell - Currently in - Europe, - Start
ImmunoGen lung cancer Phase I to Japan Phase I
Inc. - Neuroendocrine establish maximum (UK)
(USA) tumors tolerated dose Q3 2002
- Carcinoid (weekly dosing) - Start
- CTX granted for Phase II
UK Phase I study Q4 2002
(more frequent
dosing)
----------- --------------- ------------------- ---------- -----------
E21R - CMML - AML Phase II - Global - Start
BresaGen - JMML study stopped JMML
Ltd (EU orphan - CMML pilot develop-
(Australia) status Phase II study ment
designation) ongoing Q3 2002
- JMML development - CMML
under discussion Phase II
with regulators results
and external Q4 2003
experts
----------- --------------- ------------------- ---------- -----------
MG98 - Gastric - AML/MDS Phase I - Europe - Start
MethylGene cancer dose and schedule European
Inc. - AML/MDS optimizing study studies
(Canada) - Other cancers ongoing Q4 2002
involving - Head/neck cancer,
hyper- renal carcinoma
methylation Phase II studies
-- recruitment
closed
----------- --------------- ------------------- ---------- -----------
BB-10153 - Acute - Phase II in AMI - Global - Phase II
myocardial to start in July data
infarction (in collaboration Q2 2003
- Stroke with TIMI Study
- Peripheral Group)
arterial
occlusion
----------- --------------- ------------------- ---------- -----------
BB-83698 - Community- - Pre-clinical - Global - Start
acquired Phase I
pneumonia i.v.
(hospitalized study
patients) October
2002
----------- --------------- ------------------- ---------- -----------
BB-10901 -- BB-10901 is being developed jointly by British Biotech and the US biotechnology company ImmunoGen, Inc (Nasdaq: IMGN). It is an immunoconjugate of the cytotoxic cy·to·tox·ic adj. Of, relating to, or producing a toxic effect on cells. cy  to·tox·ic maytansinoid drug, DM1, with the
humanized monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing huN901 and is designed to selectively kill
certain types of cancer cells cells once believed to be peculiar to cancers, but now know to be epithelial cells differing in no respect from those found elsewhere in the body, and distinguished only by peculiarity of location and grouping.See also: Cancer including those found in small cell lung cancer Lung Cancer, Small Cell Definition Small cell lung cancer is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description Lung cancer is divided into two main types: small cell and non-small cell. (SCLC SCLC abbr. Southern Christian Leadership Conference ). In pre-clinical studies, and in contrast to current cytotoxic therapy, BB-10901 completely eradicated SCLC tumors. In May 2001, British Biotech began a combined Phase I/II clinical study at two centers in the USA to evaluate the safety, tolerability and biological activity of weekly infusions of BB-10901. Initial Phase I data were presented at the 2002 meeting of the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. . These showed the drug was well tolerated, with no dose-limiting toxicity, at weekly doses up to and including 60mg/m2. Recruitment of patients at the sixth dose level of 75mg/m2 is continuing. Once the maximum tolerated dose has been established, an additional 29 patients will be treated at that dose in the Phase II portion of the study. This progression to Phase II is expected in Q4 2002. In April 2002, the UK's Medicines Control Agency granted a Clinical Trials Exemption (CTX CTX Context (Management; Tandem) CTX Centex Corporation (stock symbol) CTX Centrex CTX Cyclophosphamide CTX Corporate Trade Exchange CTX Cytoxan CTX Cholera Toxin CTX Clinical Trial Exemption ) to British Biotech for a Phase I study of BB-10901 to investigate the safety of the drug when administered on a more frequent dosing regime. This study is expected to start shortly; further details will be published when the study begins. British Biotech has commercialization rights for BB-10901 in Europe and Japan. ImmunoGen retained rights for America and the rest of the world. E21R -- E21R is a modified form of granulocyte-macrophage colony-stimulating factor granulocyte-macrophage colony-stimulating factor n. A naturally occurring protein that stimulates the production of granulocytes and macrophages by stem cells and is used as a drug by some immunosuppressed individuals. (GM-CSF GM-CSF granulocyte-macrophage colony-stimulating factor. Granulocyte/macrophage colony stimulating factor (GM-CSF) A substance produced by cells of the immune system that stimulates the attack upon foreign cells. ) being developed in collaboration with the Australian biotechnology company, BresaGen Ltd. (ASX ASX See: Australian Stock Exchange : BGN BGN In currencies, this is the abbreviation for the Bulgarian Lev. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. ). BresaGen completed Phase I clinical testing of E21R in 2000. In August 2001, British Biotech started a Phase II study to investigate E21R's efficacy, safety, tolerability and pharmacokinetics in patients with acute myeloid leukemia myeloid leukemia n. See myelogenous leukemia. (AML AML - A Manufacturing Language ). This study has now been stopped since new pre-clinical data have failed to support the previous high incidence of apoptosis apoptosis or programmed cell death Mechanism that allows cells to self-destruct when stimulated by the appropriate trigger. It may be initiated when a cell is no longer needed, when a cell becomes a threat to the organism's health, or for other reasons. (cell killing) in AML. Further pre-clinical studies are under way to assess the rationale for development of E21R in AML. These new pre-clinical data do not call into question the rationale for development of E21R in chronic myelomonocytic leukemia leukemia (l  kē`mēə), cancerous disorder of the blood-forming tissues (bone marrow, lymphatics, liver, spleen) characterized by excessive production of immature or mature (CMML CMML Chronic Myelomonocytic LeukemiaCMML Continuous Media Markup Language CMML Civilian Manpower Management Letter ) and juvenile myelomonocytic leukemia (JMML JMML Juvenile Myelomonocytic Leukemia ). BresaGen is continuing to recruit patients to a pilot Phase II study in CMML. Also, in March 2002, the European Commission European Commission, branch of the governing body of the European Union (EU) invested with executive and some legislative powers. Located in Brussels, Belgium, it was founded in 1967 when the three treaty organizations comprising what was then the European Community designated E21R as having orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the status for the treatment of JMML, a rare and deadly disease affecting very young children. The orphan designation is based on the rare and serious nature of the disease, the lack of satisfactory therapy and the product's potential to have significant therapeutic benefit. Discussions with regulators and clinical experts on the appropriate clinical development program in JMML are ongoing. Under its collaboration with BresaGen, British Biotech has exclusive worldwide rights to commercialize E21R for all indications. MG98 -- In February 2002, British Biotech was granted European development and commercialization rights for MG98, a novel second-generation antisense antisense, DNA or RNA manipulated in a laboratory so that its components (nucleotides) form a complementary copy of normal, or "sense," messenger RNA (mRNA; see nucleic acid). compound discovered by MethylGene Inc., a privately held Canadian company. MG98 is designed to inhibit the expression of DNA methyltransferase In biochemistry, the DNA methyltransferase (DNA MTase) family of enzymes catalyze the transfer of a methyl group to DNA. DNA methylation serves a wide variety of biological functions. All the known DNA methyltransferases use S-adenosyl methionine (SAM) as the methyl donor. (DNMT DNMT DNA Methyl Transferase DNMT do not move this DNMT Definitely Not My Type ), an enzyme implicated im·pli·cate tr.v. im·pli·cat·ed, im·pli·cat·ing, im·pli·cates 1. To involve or connect intimately or incriminatingly: evidence that implicates others in the plot. 2. in uncontrolled tumor growth. MethylGene granted North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. development and commercialization rights for MG98 to MGI MGI Mouse Genome Informatics MGI Modular Gateway Interface MGI McKinsey Global Institute MGI Military Geographic Information MGI Marine Geological Institute MGI Policy on the Management of Government Information (Canada) PHARMA in August 2000. During the Phase I trials of MG98, one patient receiving MG98 under a twice-weekly regimen experienced a sustained (>6 months) objective partial response (>70% reduction in the sum of bidimensional products of measurable lesions). This regimen was well tolerated in the all-comer solid tumor population examined, and this regimen was chosen for use in the first Phase II trials. Two such North American Phase II studies investigating twice-weekly administration of MG98 monotherapy monotherapy /mono·ther·a·py/ (-ther´ah-pe) treatment of a condition by means of a single drug. mon·o·ther·a·py n. Treatment of a disorder with a single drug. in patients with head and neck cancer (conducted by MethylGene) and renal cell carcinoma renal cell carcinoma or hypernephroma Malignant tumour of the cells that cover and line the kidney. It usually affects persons over age 50 who have vascular disorders of the kidneys. It seldom causes pain, unless it is advanced. (sponsored by MethylGene in collaboration with the National Cancer Institute of Canada Clinical Trials Group) have closed recruitment. In these studies MG98, at the doses and twice-weekly schedule tested, did not demonstrate objective clinical responses as defined by the protocols. A Phase I trial investigating multiple doses and schedules in patients with advanced myelodysplasia and acute myeloid leukemia, in order to optimize dose and schedule for additional trials, was initiated by MGI PHARMA in January 2002 and continues to recruit patients. British Biotech plans to initiate in Q4 2002 a further Phase I study to investigate the safety and tolerability of a continuous infusion regimen in patients with solid tumors such as gastric adenocarcinoma adenocarcinoma: see neoplasm. . Results from these Phase I studies will form the basis of any future Phase II program. BB-10153 -- BB-10153 is a novel thrombolytic thrombolytic /throm·bo·lyt·ic/ (throm?bo-lit´ik) dissolving or splitting up a thrombus, or an agent that so acts. thrombolytic 1. dissolving or splitting up a thrombus. 2. an agent that dissolves or splits up a thrombus. (clot-busting) agent discovered by British Biotech. It is an engineered form of human plasminogen plasminogen /plas·min·o·gen/ (plaz-min´ah-jen) the inactive precursor of plasmin, occurring in plasma and converted to plasmin by the action of urokinase. plas·min·o·gen n. , modified so that it is activated to plasmin plasmin /plas·min/ (plaz´min) an endopeptidase occurring in plasma as plasminogen, which is activated via cleavage by plasminogen activators; it solubilizes fibrin clots, degrades other coagulation-related proteins, and can be activated by thrombin thrombin: see blood clotting. , which is only produced at the site of fresh blood clots Blood Clots Definition A blood clot is a thickened mass in the blood formed by tiny substances called platelets. Clots form to stop bleeding, such as at the site of cut. , rather than by the body's natural plasminogen activators Plasminogen activators can refer to:
During the year in review, GMP GMP (guanosine monophosphate): see guanine. production of material for a Phase II study was completed and in March 2002, the US Food & Drug Administration gave the go-ahead to test BB-10153 in heart attack patients. Supplies of the drug and the necessary approvals are now in place to begin this study, which will be conducted by the US-based Thrombolysis in Myocardial Infarction Thrombolysis In Myocardial Infarction (TIMI) is a large randomized controlled trial into myocardial infarction (heart attacks) and the use of thrombolysis. External links
TIMI Technology Independent Machine Interface (IBM AS/400) TIMI Technical Information Maintenance Instruction ) Study Group. The study will test the ability of BB-10153, given at doses between 1 and 5mg/kg, to dissolve clots and restore blood flow in the coronary arteries Coronary arteries The two main arteries that provide blood to the heart. The coronary arteries surround the heart like a crown, coming out of the aorta, arching down over the top of the heart, and dividing into two branches. of heart attack patients. The study will also evaluate the safety of treatment with BB-10153, especially with respect to bleeding. Data from the study are expected to be available in mid-2003 and will be used to attract potential collaborators for continued development and commercialization of this product. BB-83698 -- Targeted at community-acquired pneumonia community-acquired pneumonia Pneumonia caused by an infection currently present in the community; CAP is the most common cause of infectious death–US, and number 6 killer overall; of the 57% of CAPs in which a pathogen is identified, S pneumoniae (hospitalized patients), BB-83698 is the lead peptide deformylase inhibitor from British Biotech's Antibiotic Program. In completed pre-clinical studies BB-83698 has shown high potency against a range of gram-positive bacteria, including several drug-resistant strains. The toxicology toxicology, study of poisons, or toxins, from the standpoint of detection, isolation, identification, and determination of their effects on the human body. Toxicology may be considered the branch of pharmacology devoted to the study of the poisonous effects of drugs. studies necessary to allow human dosing have been carried out and final analysis of data is nearing completion. A Phase I clinical study in healthy volunteers, to determine the safety and pharmacokinetics of single doses of an intravenous formulation, is expected to begin in October 2002. Other Product Development Programs Batimastat BiodivYsio(R) stent -- Clinical development of this product was suspended in March 2002 pending further review of data from the BRILLIANT I clinical trial. BRILLIANT I is a 150 patient multi-center open clinical trial, recruitment for which was completed in November 2001. Six-month angiographic and clinical follow-up on an initial group of patients from this trial indicated that the product was unlikely to show the benefit that was evident in the pre-clinical studies. Additional patient data is being collected and analyzed, after which a final decision will be made to continue or end this program. Research Antibiotic Program -- British Biotech's research into antibiotics is founded on the Company's strong intellectual property position in bacterial metalloenzyme inhibitors. The program has produced several lead compounds in research and pre-clinical development, with high potency shown against drug resistant gram-positive and gram-negative pathogens. In December 2001 Company researchers and external scientific collaborators presented details of this research at the 41st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy Antimicrobial Agents and Chemotherapy (print-ISSN 0066-4804, CODEN AMACCQ; canceled ISSN 0074-9923, canceled CODEN AACHAX) is an academic journal published by the American Society for Microbiology. (ICAAC ICAAC Interscience Conference on Antimicrobial Agents and Chemotherapy ICAAC Iowa Community College Athletic Conference ). The presentations covered the in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. and in vivo in vivo /in vi·vo/ (ve´vo) [L.] within the living body. in vi·vo adj. Within a living organism. in vivo adv. efficacy of British Biotech's peptide deformylase inhibitor compounds against a variety of drug-resistant pathogens; research into the antibiotic activity and characterization of inhibitors of the `LpxC' metalloenzyme; and the use of bio-informatics in the Company's antibiotic drug discovery program. British Biotech will be giving a further update on its Antibiotic Program at the 42nd ICAAC (San Diego San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay. , 27-30 September 2002), where eight presentations have been accepted. Serono Collaboration -- The research collaboration formed in October 2000 between British Biotech and Serono SA (SWX SWX Swiss Exchange (trademark of SWX Swiss Exchange) SWX SolidWorks (3D solid modeling CAD software) SWX Splitter / Wave Division Multiplexer : SEO (Search Engine Optimization, Search Engine Optimizer) See search engine optimization. , NYSE NYSE See: New York Stock Exchange : SRA SrA abbr. senior airman ) to identify new treatments for serious inflammatory diseases, particularly multiple sclerosis, has made good progress. The two companies have completed screening of British Biotech's compound library against pathologically relevant metalloenzyme targets, and identified selective inhibitors active against three enzyme targets involved in inflammatory indications. Cancer Program -- In February 2002, British Biotech was granted an exclusive one-year option, renewable for a second year, for European development and commercialization rights of compounds from MethylGene's research program into small molecule inhibitors of DNA methyltransferase. Biodefense Research Initiative -- As part of the UK Government's biodefence initiative, the Company has entered into an agreement with the Defence, Science and Technology Laboratory (DSTL DSTL Defence Science Technology Laboratory (UK government, part of the MoD, formally DERA) ) of Porton Down Porton Down is a UK government and military science park. It is situated slightly North-East of Porton near Salisbury in Wiltshire, England. To the North-West lies the MoD Boscombe Down test range facility which is owned by QinetiQ. to investigate the utility of selected British Biotech metalloenzyme inhibitors against anthrax anthrax (ăn`thrăks), acute infectious disease of animals that can be secondarily transmitted to humans. It is caused by a bacterium (Bacillus anthracis lethal toxin and botulin botulin /bot·u·lin/ (boch´u-lin) botulinum toxin. bot·u·lin n. See botulinus toxin. toxin. Other matters The Company has noted the recent press comment regarding Class Law, an English firm of solicitors, and putative claims against the Company in respect of events more than four years ago. The Company understands that Class Law has been attempting to solicit interest in such claims since at least February 2001 and since such time has also been regularly suggesting that proceedings against the Company are imminent. Such proceedings have not been forthcoming. The Company has considered the nature of Class Law's putative, but unspecified, claims with its legal advisers and believes them to be without merit or foundation. 2. Objectives The principal objectives for the current financial year are: o Meet the product development milestones detailed in the table above; o Add at least one new product to the portfolio through collaboration; o Form a collaboration on the Antibiotic Program; o Explore strategic growth opportunities, in particular mergers or acquisitions. 3. Financial review Profit and loss account The loss for the year ended April 30, 2002 decreased to (pound)16.9 million (US$24.7 million) (2001: (pound)23.4 million) due to reduced levels of expenditure and the profit arising from the restructuring and the transfer, in August 2001, of certain pre-clinical facilities to OSI Pharmaceuticals, Inc. Research and development tax credits of (pound)1.6 million (US$2.3 million) were recognized in the year (2001: (pound)nil), as the Company believes it has satisfied the requirements of the Finance Act 2000 for the year ended April 30, 2002. Turnover in the year amounted to (pound)1.5 million (US$2.2 million) (2001: (pound)1.6 million). The turnover resulted principally from the agreement with Serono to research, develop and commercialize metalloenzyme inhibitors in serious inflammatory disease, with (pound)1.4 million (US$2.0 million) (2001: (pound)1.3 million) of the (pound)3.3 million (US$4.8 million) received from Serono in November 2000 recognized as income in the year. Research and development expenditure for the year was (pound)2.7 million (US$3.9 million) lower at (pound)21.0 million (US$30.6 million) (2001: (pound)23.7 million) due to lower infrastructure costs following the restructuring in August 2001. Administrative expenses for the year were lower at (pound)3.8 million (US$5.5 million) (2001: (pound)4.0million) including a charge of (pound)0.2 million (US$0.3 million) (2001: (pound)nil) in respect of share options. The lower expenditure is due to savings from the restructuring implemented in August 2001. Profit of (pound)2.5 million (US$3.6 million) on the disposal of fixed assets arose on the restructuring from the transfer of certain pre-clinical facilities to OSI. The amortization of intangible fixed assets was (pound)0.2 million (US$0.3 million) (2002: (pound)0.1 million). Interest receivable was (pound)2.8 million (US$4.1 million) (2001: (pound)3.8 million) with the reduction due to lower interest rates and lower average cash balances during the year. Amounts written off investments in the year were (pound) 0.3 million (US$0.4 million) (2001: (pound)0.8 million). Cash flow The reduction in cash and short-term investment balances during the year was (pound)14.6 million (US$21.3 million) (2001: (pound)10.7 million) comprising cash utilized by operations of (pound)14.3 million (US$20.9 million) (2001: (pound)10.3 million) and financing repayments of (pound)0.3 million (US$0.4 million) (2001: (pound)0.4 million). The cash utilized by operations benefited from the receipt of (pound)8.7 million (US$12.7 million) from OSI in 2002 and from the proceeds of the sale and leaseback sale and leaseback The sale of a fixed asset that is then leased by the former owner from the new owner. A sale and leaseback permits a firm to withdraw its equity in an asset without giving up use of the asset. Also called leaseback. of the office facility of (pound)11.2 million (US$16.4 million) in 2001. Excluding these amounts, the cash utilized by operations was (pound)23.0 million (US$33.6 million) (2001: (pound)21.5 million). The increase was due to lower interest received of (pound)1.3 million (US$1.9 million), increased capital expenditure of (pound)0.8 million (US$1.2 million) on the fit-out of laboratories and offices following the OSI transaction and additional expenditure on the Product Portfolio of (pound)2.6 million (US$3.8 million). These were offset by lower infrastructure costs in the second half of the year of (pound)3.0 million (US$4.4 million) following the restructuring. These lower infrastructure costs represent a permanent annualized annualized Of or relating to a variable that has been mathematically converted to a yearly rate. Inflation and interest rates are generally annualized since it is on this basis that these two variables are ordinarily stated and compared. cost saving of some (pound)6 million (US$8.8 million). Cash and short-term investments at April 30, 2002 were (pound)50.4 million (US$73.6 million), compared with (pound)65 million at 30 April 2001.
Unaudited consolidated profit and loss account
for the year ended April 30, 2002
2002 2001
(pound)000 (pound)000
Turnover 1,450 1,588
Research and development expenditure (20,955) (23,724)
Administrative expenses (3,759) (3,997)
------- -------
Operating loss (23,264) (26,133)
Profit on disposal of fixed assets 2,505 --
Interest receivable 2,820 3,778
Amount written off investments (324) (799)
Interest payable (278) (329)
------- -------
Loss on ordinary activities before taxation (18,541) (23,483)
Taxation 1,608 130
------- -------
Loss for the financial year transferred to
reserves (16,933) (23,353)
======= =======
Loss per share (basic and diluted) (Note 3) (2.5)p (3.5)p
======= =======
Unaudited statement of total recognized gains and losses
for the year ended April 30, 2002
2002 2001
(pound)000 (pound)000
Consolidated loss for the financial year (16,933) (23,353)
Translation of overseas subsidiary financial
statements 3 25
------- -------
Total recognized losses relating to the year (16,930) (23,328)
======= =======
Unaudited consolidated balance sheet
as at April 30, 2002
2001
Restated
2002 (Note 4)
(pound)000 (pound)000
Fixed assets
Intangible assets 2,288 1,090
Tangible assets 7,996 13,053
Investments 1,906 824
-------- --------
12,190 14,967
Current assets
Debtors 3,119 5,234
Short term deposits and investments (Note 4) 50,106 64,355
Cash 308 656
-------- --------
53,533 70,245
Current liabilities
Creditors: amounts falling due within one year (8,607) (10,544)
-------- --------
Net current assets 44,926 59,701
-------- --------
Total assets less current liabilities 57,116 74,668
Creditors: amounts falling due after more than
one year (1,683) (2,442)
Provisions for liabilities and charges (250) (350)
-------- --------
Net assets 55,183 71,876
======== ========
Capital and reserves
Share capital 33,375 33,326
Share premium account 298,615 298,615
Other reserve 10,008 10,008
Profit and loss account (286,815) (270,073)
-------- --------
Total equity shareholders' funds 55,183 71,876
======== ========
Unaudited consolidated cash flow statement
for the year ended April 30, 2002
2002 2001
(pound)000 (pound)000
Net cash outflow from operating activities (19,309) (21,738)
Returns on investments and servicing of finance 2,351 3,656
Taxation -- overseas 4 130
Capital expenditure and financial investments 2,686 7,587
------- -------
Cash utilized by operations (14,268) (10,365)
Management of liquid resources 14,249 11,254
Financing (342) (381)
------- -------
(Decrease)/increase in cash in the period (361) 508
======= =======
Reconciliation of net cash flow to movement
in net funds
(Decrease)/increase in cash in the period (361) 508
Cash used to decrease debt and lease financing 462 402
Cash used to decrease liquid resources (14,249) (11,254)
Exchange adjustment 18 62
------- -------
Movement in net funds in the period (14,130) (10,282)
Net funds at May 1 62,458 72,740
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Net funds at April 30 48,328 62,458
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Analysis of net funds
Cash 308 656
Short term deposits 47,969 64,355
Short-term investments 2,137 --
Bank overdraft (16) (21)
Secured loan and finance leases (2,070) (2,532)
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48,328 62,458
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Notes 1. The financial information on the Group set out above does not constitute statutory accounts within the meaning of Section 240 of the Companies Act 1985. The financial information for the year ended April 30, 2001 is extracted from the Group's audited consolidated statutory accounts. The accounts for the financial year 2002 have yet to be delivered to the Registrar of Companies and the auditor has not yet made a report for the purposes of section 249A (2) of the Companies Act 1985. The accounts for the financial year 2001 have been delivered to the Registrar and include the report of the auditors which was unqualified and did not contain a statement under Section 237 (2) or (3) of the Companies Act 1985. 2. The results for the year ended April 30, 2002 have been prepared in accordance with UK generally accepted accounting principles. The accounting policies applied are those set out in the Annual Report and Accounts for the year ended April 30, 2001 except that the Group has adopted Financial Reporting Standards 17: Retirement Benefits; 18: Accounting Policies; and 19: Deferred Taxation. The adoption of these standards has had no impact on the financial information set out above. 3. Basic and diluted losses per share are based on the loss attributable to shareholders after taxation of (pound)16.9 million (US$24.7 million) (2001: loss of (pound)23.4 million) and on 667.2 million shares (2001: 666.4 million), being the weighted average number of shares in issue for the year. 4. Cash and short-term deposits have been restated for the year ended April 30, 2001. Short-term deposits are now included within short-term deposits and investments and cash consists solely of cash at bank and in hand. 5. Where they appear, U.S. Dollar figures have been translated at (pound)1=US$1.46. |
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