British Biotech plc -- ``British Biotech'' -- Interim Results for the Six Months Ended October 31, 2001.Business Editors OXFORD, England--(BUSINESS WIRE)--Nov. 23, 2001 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] (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) )(Nasdaq:BBIOY) today announced its interim results for the six months ended October 31, 2001. Highlights of the period include: -- Patient studies initiated with three products -- Phase I for BB-10901 in small cell lung cancer -- Phase II for E21R in acute myeloid leukemia -- Registry study for the Batimastat BiodivYsio(R) stent in restenosis -- Manufacturing under way for a phase II study of the novel thrombolytic, BB-10153 -- Restructuring completed, non-core assets sold -- Loss for the half year of (pound)8.4 million (US$12.2 million) (2000: (pound)12.2 million) -- Substantially reduced cash burn for the half year of (pound)2.8 million (US$4.1 million) (2000: (pound)14.0 million) -- Cash balance at October 31, 2001 of (pound)62.2 million (US$90.2 million) Dr Elliot Goldstein Gold·stein , Joseph Leonard Born 1940. American biochemist. He shared a 1985 Nobel Prize for discoveries related to cholesterol metabolism. , Chief Executive Officer of British Biotech, said: "The turnaround Turnaround A situation where a company that has had poor performance for an extended period of time experiences a positive reversal. Notes: A speculator may profit from a turnaround if he or she accurately anticipates the improvement of a poorly performing company. at British Biotech continues to make good progress. We have had a productive half-year in which three products started clinical studies and a major restructuring restructuring - The transformation from one representation form to another at the same relative abstraction level, while preserving the subject system's external behaviour (functionality and semantics). of the business was completed. Over the next 12 months we look forward to generating the critical proof of principle data from our existing products and substantially expanding the Product Portfolio." For more information please contact British Biotech plc Tony Weir, Finance Director Tel: 011-44-1865 781166 Fax: 000-44-1865 781047 www.britishbiotech.com G.A. Kraut kraut n. 1. Sauerkraut. 2. often Kraut Offensive Slang Used as a disparaging term for a German. [German; see sauerkraut.] Noun 1. Company Gerard Coffey, Vice President Tel: 212-696-5600 Fax: 212-685-2413 www.gakraut.com Safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. statement: 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. November 23, 2001 NASDAQ: BBIOY British Biotech plc ("British Biotech") Interim Results for the six months ended October 31, 2001 Business Review In the half-year to October 31, 2001 British Biotech, in collaboration with its partners, has continued to develop its Product Portfolio. During the period, patient studies were started with three products. In August, management implemented a major restructuring to intensify in·ten·si·fy v. in·ten·si·fied, in·ten·si·fy·ing, in·ten·si·fies v.tr. 1. To make intense or more intense: the focus on drug development, add to cash resources and significantly reduce fixed infrastructure costs through the transfer of part of British Biotech's pre-clinical research operations to 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 (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 ). Together with 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 offices and laboratories in April 2001, this transaction completed the sale of non-core assets, in total raising (pound)20 million (US$29.0 million) in calendar year 2001. Following the restructuring British Biotech has 86 full-time employees. Product Portfolio BB-10901 (Collaboration with ImmunoGen immunogen /im·mu·no·gen/ (im´un-ah-jen) any substance capable of eliciting an immune response. im·mu·no·gen n. See antigen. immunogen substance that elicits an immune response. , Inc, USA) Patient recruitment in the phase I/II dose-ranging study A dose-ranging study is a clinical trial where different doses of an agent (e.g. a drug) are tested against each other to establish which dose works best and/or is least harmful. Dose-ranging is usually a phase I or early phase II clinical trial. 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. commenced in June 2001 at two centers in Texas and is progressing well. Testing has been completed at dose levels of 5, 10 and 20 mg/m2 without dose-limiting toxicity toxicity /tox·ic·i·ty/ (tok-sis´i-te) the quality of being poisonous, especially the degree of virulence of a toxic microbe or of a poison. ; treatment at the fourth dose level of 40mg/ m2 is now under way. Next milestone: escalate es·ca·late v. es·ca·lat·ed, es·ca·lat·ing, es·ca·lates v.tr. To increase, enlarge, or intensify: escalated the hostilities in the Persian Gulf. v.intr. to maximum tolerated dose; start phase II segment of study - Q2 2002 E21R (Collaboration with BresaGen Ltd, Australia) A phase II study of E21R in patients with acute myeloid leukemia myeloid leukemia n. See myelogenous leukemia. was initiated in August 2001. Five patients have now received E21R and recruitment of suitable patients is continuing at four UK hospitals. Further sites in Europe are being evaluated for expansion of this trial. In addition, BresaGen is continuing to recruit patients for a phase II study of E21R in chronic myelomonocytic myelomonocytic /my·elo·mono·cyt·ic/ (mi?e-lo-mon?o-sit´ik) characterized by both myelocytes and monocytes. 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 .Next milestone: phase II results - Q4 2002 Batimastat batimastat Oncology An anticancer angiogenesis inhibitor of matrix metalloproteinase BiodivYsio(R)stent stent (stent) 1. a device or mold of a suitable material, used to hold a skin graft in place. 2. a slender rodlike or threadlike device used to provide support for tubular structures that are being anastomosed, or (Collaboration with Biocompatibles International plc, UK) The first patient trial of the batimastat-coated BiodivYsio(R) vascular vascular /vas·cu·lar/ (vas´ku-ler) 1. pertaining to vessels, particularly blood vessels. 2. indicative of a copious blood supply. vas·cu·lar adj. stent started in August 2001. The purpose of this multi-center European European emanating from or pertaining to Europe. European bat lyssavirus see lyssavirus. European beech tree fagussylvaticus. European blastomycosis see cryptococcosis. study is to determine the safety and efficacy of the stent and full recruitment of 150 patients into the study was completed in November. A European pivotal study is scheduled to start in December 2001, with a second pivotal study planned to start in the USA in the first half of 2002. Next milestones: start EU pivotal study - Q4 2001; start US pivotal study - Q2 2002 BB-10153 Manufacture of BB-10153 for a phase II proof of principle study is progressing to plan at DSM 1. DSM - Data Structure Manager. An object-oriented language by J.E. Rumbaugh and M.E. Loomis of GE, similar to C++. It is used in implementation of CAD/CAE software. DSM is written in DSM and C and produces C as output. Biologics in Canada. The first of four batches of the product has been prepared and is undergoing release testing. Meetings with external experts and regulators have been held to review the clinical development plan for this 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. . An Investigational New Drug (IND) application is planned for early 2002. Next milestone: file IND, start phase II - Q1 2002 Research British Biotech's research concentrates on new approaches to serious 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; and the discovery of 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. . Research into inflammatory disease, conducted in collaboration with Serono SA, Europe's largest biotechnology company, is progressing well. British Biotech's in-house research into new classes of drugs that will overcome the serious problem of antibiotic resistance antibiotic resistance, n the ability of certain strains of microorganisms to develop resistance to antibiotics. antibiotic resistance has also made good progress. In pre-clinical studies the Antibiotic antibiotic, any of a variety of substances, usually obtained from microorganisms, that inhibit the growth of or destroy certain other microorganisms. Types of Antibiotics Program's lead compounds, peptide peptide, organic compound composed of amino acids linked together chemically by peptide bonds. The peptide bond always involves a single covalent link between the α-carboxyl (oxygen-bearing carbon) of one amino acid and the amino nitrogen of a second amino acid. deformylase (PDF (Portable Document Format) The de facto standard for document publishing from Adobe. On the Web, there are countless brochures, data sheets, white papers and technical manuals in the PDF format. ) inhibitors, have shown high potency potency /po·ten·cy/ (po´ten-se) 1. the ability of the male to perform coitus. 2. the relationship between the therapeutic effect of a drug and the dose necessary to achieve that effect. 3. against gram positive bacteria, in particular drug-resistant strains of Streptococcus pneumoniae Streptococcus pneu·mo·ni·ae n. Pneumococcus. Streptococcus pneumoniae Microbiology A pathogenic streptococcus with 90 serotypes associated with pneumonia, bacteremia, meningitis Transmission Person to person Incidence . The Company aims to initiate clinical studies with the program's lead compound in 2002 and talks are in progress with other companies to form an R&D collaboration for this program. Next milestones: secure collaboration; start phase I study with lead antibiotic - 2002 Financial Review Profit and loss account The loss for the six months ended October 31, 2001 decreased to (pound)8.4 million (US$12.2 million) (2000: (pound)12.2 million). Turnover in the half year was (pound)0.7 million (US$1.0 million) (2000: (pound)0.1 million) and resulted from recognition of a proportion of the US$5 million received from Serono in November 2000. Research and development expenditure was lower at (pound)10.8 million (US$15.7 million) (2000: (pound)12.2 million) due to lower levels of infrastructure resulting from cost-reduction initiatives. Administrative expenditure increased to (pound)2.3 million (US$3.3 million) (2000: (pound)1.9 million) due to reorganization costs. Profit on disposal of fixed assets fixed assets npl → activo sg fijo fixed assets npl → immobilisations fpl fixed assets fix npl → was (pound)1.9 million (US$2.8 million) (2000: (pound)nil) and arose on the transfer of certain pre-clinical operations to OSI. Research and development tax credits of (pound)0.7 million (US$1.0 million) (2000: (pound)nil) were recognized as the Company believes it will satisfy the requirements of the Finance Act 2000 in the year ending April 30, 2002. Cash flow Cash and short-term deposits at October 31, 2001 were (pound)62.2 million (US$90.2 million), compared with (pound)65.0 million at April 30, 2001 and (pound)61.7 million (US$89.5 million) at October 31, 2000. The net cash outflow in the half-year of (pound)2.8 million (US$4.1 million) benefited from the receipt of (pound)8.2 million (US$11.9 million) from OSI. Excluding this receipt, the cash outflow in the half-year was reduced to (pound)11.0 million (US$16.0 million) (2000: (pound)14.0 million). The reduction was due to the lower loss for the period and the payment last year of $1.5 million to ImmunoGen to acquire the rights to BB-10901. Outlook British Biotech's key objectives for 2002 are: -- progress the Product Portfolio to generate key proof of principle data; -- acquire commercialization rights to at least one new drug in clinical development; -- form a research and development collaboration for the Antibiotic program; and -- start clinical trials of lead antibiotic. The Board is also evaluating other opportunities to expand significantly the Product Portfolio. British Biotech is particularly well placed in this respect, due to the Company's expertise in drug development, proven track record in collaborating to acquire new drug opportunities, strong cash position and strategically advantageous position in Europe. British Biotech will actively pursue alliances and corporate transactions to achieve this objective.
Unaudited consolidated profit and loss account
For the half year ended October 31, 2001
Half year Half year Full year
ended ended ended
October 31, October 31, April 30,
2001 2000 2001
(pound)000 (pound)000 (pound)000
Turnover 722 50 1,588
Research and development
expenditure (10,810) (12,183) (23,724)
Administrative expenses (2,307) (1,947) (3,997)
--------- -------- --------
Operating loss (12,395) (14,080) (26,133)
Profit on disposal of
fixed assets (note 2) 1,945 - -
--------- -------- --------
Loss on ordinary
activities before
interest (10,450) (14,080) (26,133)
Interest receivable 1,589 2,060 3,778
Interest payable (147) (193) (329)
Amount written off
investment - - (799)
--------- -------- --------
Loss on ordinary
activities before
taxation (9,008) (12,213) (23,438)
Taxation (note 3) 653 - 130
--------- -------- --------
Loss for the period (8,355) (12,213) (23,353)
--------- -------- --------
Loss per share (basic and
diluted) (note 4) (1.3)p (1.8)p (3.5)p
--------- -------- --------
Unaudited statement of total recognized gains and losses
For the half year ended October 31, 2001
Half year Half year Full year
ended ended ended
October 31, October 31, April 30,
2001 2000 2001
(pound)000 (pound)000 (pound)000
Consolidated
loss for the
period (8,355) (12,213) (23,353)
Translation of
overseas subsidiary
financial statements - 3 25
--------- -------- --------
Total losses
recognized for
the period (8,355) (12,210) (23,328)
--------- -------- --------
Unaudited consolidated balance sheet
At At At
October 31, October 31, April 30,
2001 2000 2001
(pound)000 (pound)000 (pound)000
Fixed assets
Intangible assets
(note 6) 1,186 1,236 1,090
Tangible assets 7,301 25,930 13,053
Investments 824 974 824
------------ ------------- -------------
9,311 28,140 14,967
Current assets
Debtors 2,493 5,963 5,234
Cash and short term
bank deposits 62,205 61,724 65,011
------------ ------------- -------------
64,698 67,687 70,245
Current liabilities
Creditors: amounts
falling due within
one year (8,284) (10,216) (10,544)
------------ ------------- -------------
Net current assets 56,414 57,471 59,701
Total assets less
current liabilities 65,725 85,611 74,668
Creditors: amounts
falling due after
more than one year (1,913) (2,330) (2,442)
Provision for
liabilities and
charges (200) (300) (350)
------------ ------------- -------------
Net assets 63,612 82,981 71,876
------------ ------------- -------------
Capital and reserves
Share capital 33,353 33,313 33,326
Share premium account 298,615 298,613 298,615
Other reserve 10,008 10,008 10,008
Profit and loss
account (278,364) (258,953) (270,073)
------------ ------------- -------------
Total equity
shareholders' funds 63,612 82,981 71,876
------------ ------------- -------------
Unaudited consolidated cash flow statement
For the half year ended October 31, 2001
Half year Half year Full year
ended ended ended
October 31, October 31, April 30,
2001 2000 2001
(pound)000 (pound)000 (pound)000
Net cash outflow from
operating activities (10,141) (13,692) (21,738)
Return on investments
and servicing of
finance 1,279 1,915 3,656
Taxation - overseas - - 130
Capital expenditure
(note 7) 6,270 (2,048) 7,587
--------------------------------------
Cash utilised by
operations (2,592) (13,825) (10,365)
Management of liquid
resources 2,473 14,270 11,254
Financing (173) (198) (381)
--------------------------------------
(Decrease)/increase
in cash in the period (292) 247 508
--------------------------------------
Reconciliation of net
cash flow to movement
in net funds
(Decrease)/increase in
cash in the period (292) 247 508
Cash used to decrease
debt and lease
financing 201 206 402
Net movement in
liquid resources (2,473) (14,270) (11,254)
Exchange adjustment (20) 44 62
--------------------------------------
Movement in net
funds in the period (2,584) (13,773) (10,282)
Net funds at start
of the period 62,458 72,740 72,740
--------------------------------------
Net funds at end of
the period (note 8) 59,874 58,967 62,458
--------------------------------------
Notes 1. The interim financial information on the Group set out above has been prepared on the basis of the accounting policies set out in the Group's statutory accounts for the year ended April 30, 2001. The Group has also adopted all recently published accounting standards: FRS FRS abbr. Fellow of the Royal Society FRS, n “flexed rotated side-bent,” an osteopathic abbreviation used to describe vertebral position in cases of spinal dysfunction. 17 Retirement Benefits; FRS18 Accounting Policies; and FRS19 Deferred Tax, and none of these standards had any impact on adoption. This interim financial information does not constitute statutory accounts within the meaning of Section 240 of the Companies Act 1985 but has been reviewed by the auditors in accordance Accordance is Bible Study Software for Macintosh developed by OakTree Software, Inc.[] As well as a standalone program, it is the base software packaged by Zondervan in their Bible Study suites for Macintosh. with bulletin 1999/4 issued by the Auditing Practices Board; their report to the Company is set out on page 9. The Group's statutory accounts for the year ended April 30, 2001 have been delivered to the Registrar of Companies The introduction to this article provides insufficient context for those unfamiliar with the subject matter. Please help [ improve the introduction] to meet Wikipedia's layout standards. You can discuss the issue on the talk page. ; the report of the auditors on these accounts was unqualified and did not contain a statement under Section 237 (2) or (3) of the Act. 2. The profit on disposal of fixed assets arises from the agreement signed with OSI whereby 59 British Biotech employees have transferred to OSI along with the leases on two properties and certain fixed assets. A further (pound)0.5m (US$0.7 million) of consideration is receivable subject to certain conditions and recognition of this is deferred until March 2002. 3. Following the introduction of Research and Development Tax Credits as part of the Finance Act 2000, the Group has recognized the R&D tax credit in respect of the first half of the year. 4. Loss per share is based on the loss attributable to shareholders of (pound)8.4 million (US$12.2 million) (2000: (pound)12.2 million) and on 667 million shares (2000: 666 million), being the weighted average number of shares in issue for the half year. 5. The directors do not propose a dividend for the period. 6. Collaborative milestone payments for the six months ended October 31, 2000 have been reclassified as intangible assets Intangible Asset An asset that is not physical in nature. Notes: Examples are things like copyrights, patents, intellectual property, and goodwill. These are the opposite of tangible assets. in that period to reflect the group accounting policy applied for the year ended April 30, 2001. 7. Capital expenditure consists of profits on the sale of fixed assets of (pound)6.8 million (US$9.9 million) (2000: nil) less purchase of fixed assets of (pound)0.6 million (US$0.9 million) (2000: (pound)2.0 million). 8. Net funds consist of cash at bank and short-term deposits of (pound)62.2 million (US$90.2 million) (2000: (pound)61.7 million) less (pound)2.3 million (US$3.3 million) of secured loans (2000: (pound)2.7 million). 9. A copy of the interim results for the six months ended October 31, 2001 will be sent to shareholders before the end of December 2001. Further copies of the interim results are available from the Company's registered office at: British Biotech plc, Watlington Road, Oxford OX4 6LY. 10. Where they appear, U.S. dollar amounts were translated at the rate (pound)1=US$1.45 Independent Review Report to British Biotech plc Introduction We have been instructed by the company to review the financial information which comprises the consolidated profit and loss account, consolidated statement of total recognized gains Recognized Gain The amount of gain reported for income tax purposes. Notes: You can defer recognizing some gains until the following year(s). See also: Capital Gain, Capital Loss, Deferred Income Tax, Drought Sale, Exempt Income, Exemption, Gain, Recognized Loss and losses, consolidated balance sheet consolidated balance sheet A balance sheet in which assets and liabilities of a parent company and its controlled subsidiaries are combined, thereby presenting balance sheet items for the parent and its subsidiaries as if they were a single firm. , consolidated cash flow statement, and the related notes 1 to 9. We have read the other information contained in the interim report and considered whether it contains any apparent misstatements or material inconsistencies with the financial information. Directors' responsibilities The interim report, including the financial information contained therein, is the responsibility of, and has been approved by the directors. The directors are responsible for preparing the interim report in accordance with the Listing Rules of the Financial Services Authority The Financial Services Authority ("FSA") is an independent non-departmental public body and quasi-judicial body that regulates the financial services industry in the United Kingdom. Its main office is based in Canary Wharf, London, with another office in Edinburgh. which require that the accounting policies and presentation applied to the interim figures should be consistent with those applied in preparing the preceding annual accounts except where any changes, and the reasons for them, are disclosed. Review work performed We conducted our review in accordance with guidance contained in Bulletin 1999/4 issued by the Auditing Practices Board for use in the United Kingdom. A review consists principally of making enquiries of group management and applying analytical procedures Analytical Procedures is one of financial audit skill which help an auditor understand the client's business and changes in the business, to identify potential risk areas and to plan other audit procedures. to the financial information and underlying financial data and, based thereon there·on adv. 1. On or upon this, that, or it. 2. Archaic Following that immediately; thereupon. Adv. 1. thereon - on that; "text and commentary thereon" on it, on that , assessing whether the accounting policies and presentation have been consistently applied unless otherwise disclosed. A review excludes audit procedures such as tests of controls and verification of assets, liabilities and transactions. It is substantially less in scope than an audit performed in accordance with United Kingdom Auditing Standards and therefore provides a lower level of assurance than an audit. Accordingly we do not express an audit opinion on the financial information. Review conclusion On the basis of our review we are not aware of any material modifications that should be made to the financial information as presented for the six months ended October 31, 2001. PricewaterhouseCoopers, Chartered Accountants char·tered accountant n. Chiefly British Abbr. CA A member of one of the institutes of accountants granted a royal charter. London November 23, 2001 |
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