British Biotech plc --"British Biotech"-- Preliminary results for the year ended April 30, 2000.Business Editors OXFORD, England--(BUSINESS WIRE)--July 5, 2000 Highlights - Development portfolio increased to six products by addition of: - BB-2827 for rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. - Collaboration with ImmunoGen to develop and commercialize huN901-DM1 for 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. - BB-76163 for chronic inflammatory disease Noun 1. inflammatory disease - a disease characterized by inflammation disease - an impairment of health or a condition of abnormal functioning NEC, necrotizing enterocolitis - an acute inflammatory disease occurring in the intestines of premature infants; - develop and commercialize its products; - broaden its development portfolio; and - Cash burn reduced to(pound)22.2 million (US$34.4 million) (1999:(pound)34.8 million) - develop and commercialize its products; - broaden its development portfolio; and Dr Elliot Goldstein, Chief Executive Officer of 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] , commented: "We have made substantial progress during the year and now have six products in development. Our research is directed at new classes of antibiotics Antibiotics Definition Antibiotics may be informally defined as the subgroup of anti-infectives that are derived from bacterial sources and are used to treat bacterial infections. discovered by British Biotech and our external focus has increased with the signing of several significant collaborative agreements. With this solid foundation and strong financial position exciting new opportunities are emerging for our Company." 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. which 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 related to the regulatory process. British Biotech plc Preliminary results for the year ended April 30, 2000 Strategy British Biotech is focused on the development of innovative products for cancer, inflammation and infection. The strategy is to: - develop and commercialize its products; - broaden its development portfolio; and - focus metalloenzyme inhibitor inhibitor /in·hib·i·tor/ (in-hib´i-tor) 1. any substance that interferes with a chemical reaction, growth, or other biologic activity. 2. (MEI) research to deliver a new class of antibiotics; - develop and commercialize its products; - broaden its development portfolio; and - collaborate for late stage development and marketing, while retaining commercialization rights to niche markets A niche market also known as a target market is a focused, targetable portion (subset) of a market sector. By definition, then, a business that focuses on a niche market is addressing a need for a product or service that is not being addressed by mainstream providers. Financial review The loss for the year ended April 30, 2000 decreased to (pound)25.4 million (US$39.4 million) (1999: (pound)39.8 million) due to reduced levels of expenditure. Turnover in the year amounted to (pound)2.6 million (US$4.0 million) (1999: (pound)4.2 million) and resulted principally from the agreement with Schering-Plough to develop and commercialize matrix metalloproteinase inhibitors (MMPIs) for cancer. Total expenditure, excluding one-off charges, decreased to (pound)32.4 million (US$50.2 million) (1999: (pound)43.6 million) of which research and development expenditure was (pound)26.7 million (US$41.4 million) (1999: (pound)35.4 million) and administrative expenditure was (pound)5.7 million (US$8.8 million) (1999: (pound)8.2 million). The reduction was due to lower headcount, decreased levels of expenditure on clinical trials, particularly in relation to marimastat, and reductions in infrastructure. One-off charges were (pound)nil (1999: (pound)8.5 million). Net interest received decreased to (pound)4.3 million (US$6.7 million) (1999: (pound)8.4 million) due to lower average cash balances during the year. Overall headcount reduced from 311 to 237 during the financial year. On June 9, 2000, the Company announced a reorganization to exploit its development opportunities with a consequent further reduction in headcount, predominantly from Research and central support, to 140. These changes will generate 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 savings of (pound)8 million (US$12.4 million) which will be invested in progressing and broadening the development portfolio. The cash burn reduced to (pound)22.2 million (US$34.4 million) (1999: (pound)34.8 million) and comprised cash utilized by operations of (pound)24.9 million (US$38.6 million) and financing of (pound)2.7 million (US$4.2 million) principally from the issue of shares to Schering-Plough on signature of the agreement to develop and commercialize MMPIs for cancer. The lower cash burn is consistent with the reduced operating loss operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. and lower levels of capital expenditure. Net investment in capital expenditure decreased to (pound)0.2 million (US$0.3 million) (1999: (pound)1.7 million), and comprised (pound)1.1 million (US$1.7 million) on laboratory equipment offset by (pound)0.9 million (US$1.4 million) received from the disposal of surplus assets. Asset purchases to the value of (pound)0.5 million (US$0.8 million) were funded by leasing arrangements. Product portfolio British Biotech has six products in development. The Company's core research capability targets metalloenzymes and is principally focused on infectious disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. . Marimastat, an oral MMPI MMPI abbr. Minnesota Multiphasic Personality Inventory MMPI Child psychiatry A personality assessment tool widely used in making psychologic evaluations, which is normally given at age 16 and older. Personality testing in development as an anti-cancer agent, was licensed to Schering-Plough in September 1999. Four Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA studies, in patients with very advanced disease, have now reported, all of which failed to meet their primary end-point. Based on clinical experience with marimastat, and consistent with its mode of action, it appears that patients with less advanced disease are more likely to respond to treatment with marimastat. The patient population in two Phase III studies in small cell lung cancer represents the most suitable setting in which marimastat is being tested, and results from these trials are expected later this year. BB-3644 is a second-generation oral MMPI in development as an anti-cancer agent and is also subject to the collaboration with Schering-Plough. In preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. models, BB-3644 shows potent anti-cancer properties without the joint-pain seen with marimastat. BB-3644 has completed a Phase Ia study in healthy volunteers which showed it to be well tolerated and orally absorbed. A Phase Ib maximum tolerated dose trial is under way to determine whether the benefit shown in preclinical models is seen in cancer patients. If this study is positive, BB-3644 will move into Phase II trials by mid 2001. BB-10153, a genetically engineered genetically engineered adjective Recombinant, see there protein, has shown both 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 dissolving) and anti-thrombotic (clot prevention) properties in preclinical models. It is being developed as a potential treatment for cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease , including heart attack and stroke. BB-10153 has completed a Phase I study which showed it to be well tolerated in healthy volunteers. Manufacture for Phase II is under way and a partner is being sought to develop and commercialize this product. BB-2827 is an orally-absorbed collagenase collagenase /col·la·ge·nase/ (kah-laj´e-nas) an enzyme that catalyzes the hydrolysis of peptide bonds in triple helical regions of collagen. col·lag·e·nase n. inhibitor which entered development in October 1999 for the treatment of inflammation, such as rheumatoid arthritis. A Phase I clinical study in healthy volunteers is scheduled to start later this year, while preclinical work to determine the most appropriate disease indication is undertaken. huN901-DM1 has been in-licensed from ImmunoGen Inc. of Boston, USA and is a 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) targeting small cell lung cancer (SCLC SCLC abbr. Southern Christian Leadership Conference ) cells, coupled with a highly potent cytotoxic cy·to·tox·ic adj. Of, relating to, or producing a toxic effect on cells. cy  to·tox·ic (cell-killing) agent (DM1). When the monoclonal antibody reaches the
tumor tumor: see neoplasm. , the cytotoxic agent is released into the cell causing cell death.
In preclinical studies preclinical studies,n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. , and in contrast to current cytotoxic therapy, huN901-DM1 eradicated SCLC tumors. The Company expects to file an Investigational New Drug (IND) application in the USA later this year, prior to starting a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I . BB-76163 is an aminopeptidase a·mi·no·pep·ti·dase n. Any of various enzymes that catalyze the hydrolysis of the terminal peptide bond at the amino end of a polypeptide. aminopeptidase inhibitor which entered development in May 2000 as a potential treatment for chronic inflammatory disease, such as multiple sclerosis multiple sclerosis (MS), chronic, slowly progressive autoimmune disease in which the body's immune system attacks the protective myelin sheaths that surround the nerve cells of the brain and spinal cord (a process called demyelination), resulting in damaged areas . The preclinical studies necessary before commencing a Phase I study in 2001 are under way. Anti-infective research. British Biotech has identified several metalloenzymes which are essential for the survival of pathogenic bacteria Pathogenic bacteria Bacteria that produce illness. Mentioned in: Gastroenteritis . The most advanced program, focused on inhibitors of polypeptide polypeptide: see peptide. deformylase, is in late stage research and is expected to yield a development candidate later in 2000. These inhibitors have the potential to become a new class of antibiotics as both hospital-based, injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. drugs and oral drugs for use in the community. External collaborations British Biotech conducts its research and development programs to the highest standards and believes that expert external review is essential. During the year, the Company has established a Scientific Advisory Board and an independent Safety Board. The Scientific Advisory Board comprises multi-disciplinary experts and its role is to assist with the assessment and evaluation of research and development programs. The Safety Board provides an independent technical review and monitoring of clinical development programs. British Biotech is seeking to establish appropriate collaborations to: - develop and commercialize its products; - broaden its development portfolio; and - enhance its innovative research and development capabilities. Schering-Plough In September 1999, British Biotech and Schering-Plough entered into an agreement to develop and commercialize British Biotech's MMPIs, including marimastat and BB-3644, for the treatment of cancer. The terms of the agreement grant Schering-Plough exclusive rights to develop, manufacture and market British Biotech's MMPIs for cancer worldwide, other than in Japan and certain Far Eastern territories. Tanabe Seiyaku Co., Ltd British Biotech continues to collaborate with Tanabe to develop and commercialize marimastat for cancer in Japan and certain Far Eastern territories. ImmunoGen In May 2000, British Biotech and ImmunoGen, a NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on listed biopharmaceutical company, announced an alliance to develop and commercialize huN901-DM1 for the treatment of small cell lung cancer. British Biotech will conduct the worldwide clinical development of huN901-DM1 and has been granted the exclusive commercialization rights in the EU and Japan, while ImmunoGen retains these rights for the USA and the Rest of the World. CareScience In May 2000, a five-year collaboration with CareScience was initiated to develop and exploit a web-based analytical tool, the 'Oncology Extranet', for acquiring, managing and evaluating clinical data in the oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. field. The Oncology Extranet utilizes unique, proprietary technology developed by the University of Pennsylvania's School of Medicine and Wharton Business School and extends CareScience's existing Internet-based data and technology platform based on clinical data in 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. . The Oncology Extranet will provide British Biotech with the ability to improve the design and execution of clinical trials, thereby reducing the risk of failure and cost of drug development. In addition, it will give a better understanding of unmet needs and patient populations to target for new drug development. DevCo Pharmaceuticals In March 2000, DevCo Pharmaceuticals Limited signed an agreement with British Biotech to develop the platelet platelet: see blood clotting. platelet or thrombocyte Small, colourless, irregular blood cell crucial in coagulation. Produced in bone marrow and stored in the spleen, platelets accumulate to block a cut in a blood vessel and provide activating factor (PAF PAF platelet activating factor. PAF abbr. platelet-aggregating factor PAF platelet activating factor. ) antagonist antagonist /an·tag·o·nist/ (an-tag´o-nist) 1. a substance that tends to nullify the action of another, as a drug that binds to a cell receptor without eliciting a biological response, blocking binding of substances that could , lexipafant, for the prophylaxis prophylaxis (prō'fĭlăk`sĭs), measures designed to prevent the occurrence of disease or its dissemination. Some examples of prophylaxis are immunization against serious diseases such as smallpox or diphtheria; quarantine to confine of certain serious neurological neurological, neurologic pertaining to or emanating from the nervous system or from neurology. neurological assessment evaluation of the health status of a patient with a nervous system disorder or dysfunction. and renal complications experienced by patients undergoing cardiac surgery Cardiac surgery is surgery on the heart and/or great vessels performed by a cardiac surgeon. Frequently, it is done to treat complications of ischemic heart disease (for example, coronary artery bypass grafting), correct congenital heart disease, or treat valvular heart disease . Annual General Meeting British Biotech's 2000 Annual General Meeting will be held at 11.00am on Thursday, September 21, 2000 at the Ironmongers' Hall, Shaftesbury Place, Barbican BARBICAN. An ancient word to signify a watch-tower. Barbicanage was money given for the support of a barbican. , London, EC2Y 8AA. This news release contains forward-looking statements which 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.
Consolidated profit and loss account
For the year ended April 30, 2000
2000 1999
(pound)000 (pound)000
Turnover 2,624 4,224
Research and development expenditure (26,700) (35,389)
Administrative expenses: Corporate and (5,657) (8,206)
Commercial
Administrative expenses: One-off charges - (8,529)
(note 3) -------- --------
Operating loss (29,733) (47,900)
Interest receivable 4,663 8,790
Interest payable (317) (356)
-------- --------
Loss on ordinary activities
before taxation (25,387) (39,466)
Taxation (10) (377)
-------- --------
Loss for the financial year (25,397) (39,843)
-------- --------
Loss per share (basic and diluted)(note 4) (3.8)p (6.0)p
-------- --------
Statement of total recognized gains and losses
For the year ended April 30, 2000
2000 1999
(pound)000 (pound)000
Consolidated loss for the financial
year (25,397) (39,843)
Translation of overseas subsidiary
financial statements (49) 10
-------- --------
Total recognized losses during the year (25,446) (39,833)
======== ========
Consolidated balance sheet
at April 30, 2000
2000 1999
(pound)000 (pound)000
Tangible fixed assets 27,146 30,498
Current assets
Debtors 2,021 2,247
Cash at bank and in hand 75,959 98,560
-------- --------
77,980 100,807
Current liabilities
Creditors: amount falling due within
one year (7,112) (10,568)
-------- --------
Net current assets 70,868 90,239
Total assets less current liabilities 98,014 120,737
Creditors: amounts falling due after more
than one year (2,531) (2,430)
Provisions for liabilities
and charges (300) (616)
-------- --------
Net assets 95,183 117,691
-------- --------
Capital and reserves
Share capital 33,307 33,049
Share premium 298,613 296,240
Other reserve 10,008 10,008
Profit and loss account (246,745) (221,606)
-------- --------
Total equity shareholders' funds 95,183 117,691
-------- --------
Consolidated cash flow statement
For the year ended April 30, 2000
2000 1999
(pound)000 (pound)000
Cash outflow from operating activities (29,064) (41,095)
Returns on investments and
servicing of finance 4,437 8,448
Taxation (62) (372)
Capital expenditure and
Financial investment (198) (1,652)
-------- --------
Cash utilized by operations (24,887) (34,671)
Management of liquid resources 22,178 32,350
Financing 2,658 (142)
-------- --------
Decrease in cash in the period (51) (2,463)
-------- --------
Reconciliation of net cash flow to
movement in net funds
Decrease in cash in the period (51) (2,463)
Cash used to decrease debt and
lease financing 311 322
Cash used to decrease liquid resources (22,178) (32,350)
New finance leases (542) -
Exchange adjustment 90 (1)
-------- --------
Movement in net funds in the period (22,370) (34,492)
Net funds at May 1st 95,110 129,602
-------- --------
Net funds at April 30th 72,740 95,110
-------- --------
Analysis of net funds
Cash at bank and in hand 75,959 98,560
Bank overdraft (285) (747)
Secured loan and finance leases (2,934) (2,703)
-------- --------
72,740 95,110
-------- --------
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 years ended April 30, 1999 and 2000 are extracts from the Group's audited consolidated statutory accounts. The accounts for the financial year 2000 have yet to be delivered to the Registrar of Companies. The accounts for the financial year 1999 have been delivered to the Registrar. The report of the auditors on both sets of accounts 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, 2000 have been prepared in accordance with UK generally accepted accounting principles The standard accounting rules, regulations, and procedures used by companies in maintaining their financial records. Generally accepted accounting principles (GAAP) provide companies and accountants with a consistent set of guidelines that cover both broad accounting . The accounting policies applied are those set out in the Annual Report and accounts for the year ended April 30, 2000. 3. Administrative expenses: one-off charges,(pound)nil (1999:(pound)8.5 million). The costs for 1999 comprised the write down of fixed assets fixed assets npl → activo sg fijo fixed assets npl → immobilisations fpl fixed assets fix npl → , dilapidations, the costs associated with the litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. and regulatory inquiries, payments to departing directors and restructuring costs. Total administrative expenses for the year were(pound)5.7 million (US$8.8 million) (1999: (pound)16.7 million). 4. Basic and diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. losses per share are based on the loss attributable to shareholders after taxation of(pound)25.4 million (US$39.4 million) (1999: loss of(pound)39.8 million) and on 665.5 million shares (1999: 660.6 million), being the weighted average number of shares in issue for the year. 5. The annual report is expected to be mailed to shareholders on Tuesday, August 15, 2000 and the Annual General Meeting will be held on September 21, 2000. 6. Where they appear, U.S. dollar figures have been translated at the rate of(pound)1=US$1.55 |
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