RNS Number:7216C
Cambridge Antibody Tech Group PLC
08 September 2004
04/CAT/10
FOR IMMEDIATE RELEASE
07.00 BST, 02:00 EST Wednesday 8 September 2004
For further information contact:
Cambridge Antibody Technology Weber Shandwick Square Mile (Europe)
Tel: +44 (0) 1223 471 471 Tel: +44 (0) 20 7067 0700
Peter Chambre, Chief Executive Officer Kevin Smith
John Aston, Chief Financial Officer Sarah MacLeod
Rowena Gardner, Director of Corporate
Communications
BMC Communications/The Trout Group (USA)
Tel: +1 212 477 9007
Brad Miles, ext 17 (media)
Brandon Lewis, ext 15 (investors)
CAMBRIDGE ANTIBODY TECHNOLOGY ANNOUNCES FINANCIAL RESULTS FOR THE NINE MONTHS
ENDED 30 JUNE 2004
Cambridge, UK Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG) today
announces financial results for the nine months ended 30 June 2004 and a
business update for the period since the interim results on 17 May 2004.
Summary:
Completed enrolment of 236 patients in US clinical trial of Trabio (R)
Regulatory approval received to commence a Phase I clinical trial with CAT-354
Wyeth progressing MYO-029, licensed from CAT, into a Phase I clinical trial
Abbott increased 2004 sales expectations for HUMIRA(TM) to more than $800
million
Continued progress of licensed product candidates by partners HGSI and Abbott
New Non-Executive Director appointed; Professor Christopher Marshall
Net cash and liquid resources of #101.0 million at 30 June 2004 (#112.8 million
at 30 June 2003)
Net cash outflow before management of liquid resources and financing: #20.7
million for the nine months ended 30 June 2004 compared with #19.0 million for
the nine months ended 30 June 2003
CAT Product Candidates
The treatment phases of two pivotal trials with CATs lead proprietary product
Trabio (lerdelimumab), a human anti-TGFbeta2 monoclonal antibody being developed
for improving outcomes in glaucoma filtration surgery (trabeculectomy), have
been completed. Preliminary results are expected during the next six months.
In the Phase II/III European clinical trial of Trabio in 344 patients undergoing
first time trabeculectomy, preliminary data at one year follow-up remain on
schedule for release in the fourth quarter of 2004.
Enrolment is complete in the Phase III International clinical trial of Trabio in
393 patients undergoing first time trabeculectomy. Data from this trial are
expected in early 2005 when all patients have completed at least one year of
follow-up post surgery.
In the US clinical trial of Trabio compared to 5-fluorouracil (5FU), enrolment
has now been completed, with 236 patients randomised. One year follow-up data
are expected to be available towards the end of 2005.
In the collaboration between CAT and Genzyme, substantial research and analysis
has been carried out in the last six months with the objective of finalising
future clinical development plans for anti-TGFbeta antibodies by the end of
2004.
In August, results from the Phase I/IIa clinical trial of CAT-192 (metelimumab),
a human anti-TGFbeta1 monoclonal antibody, were presented at the International
Scleroderma Workshop in Cambridge, UK.
CAT and Genzyme are currently considering the development of GC-1008, a
pan-specific human anti-TGFbeta monoclonal antibody, for oncology indications.
Meanwhile pre-clinical safety studies of GC-1008 are continuing prior to
initiating a clinical trial in idiopathic pulmonary fibrosis. Further
pre-clinical work in other potential indications is also under way.
Regulatory approval to commence a clinical trial has been granted for CAT-354, a
human anti-IL13 monoclonal antibody being developed as a potential treatment for
severe asthma. The Phase I clinical trial is expected to begin shortly in the
UK. The objective of the trial is to evaluate safety, tolerability and
pharmacokinetics of a single intravenously administered dose of CAT-354.
HUMIRA
HUMIRA(TM) (adalimumab) is a human anti-TNFalpha monoclonal antibody which was
isolated and optimised by CAT in collaboration with Abbott Laboratories. Abbott
has reported that HUMIRA is now approved for sale in 51 countries for the
treatment of rheumatoid arthritis and achieved sales for the first half of 2004
of $351 million. Abbott is currently forecasting sales of HUMIRA of more than
$800 million in 2004 and more than $1.2 billion in 2005.
Abbott has recently presented data on HUMIRA at two major international
conferences. At the European League Against Rheumatism (EULAR) meeting in Berlin
in June 2004, positive data from three studies were presented: a ten-patient
study in ankylosing spondylitis, a 15-patient study in psoriatic arthropathy and
the 2,000 patient ReAct (Research in Active rheumatoid arthritis) study. At the
American Academy of Dermatology (AAD) meeting in New York in July 2004,
encouraging data from a Phase II, 137-patient study in chronic plaque psoriasis
were also presented.
In August 2004, Abbott announced that the US Food and Drug Administration (FDA)
had approved an expanded indication for HUMIRA to include improvement in
physical function for adult patients with moderately to severely active RA.
In November 2003, CAT commenced legal proceedings against Abbott Biotechnology
Limited and Abbott GmbH in the High Court in London concerning the level of
royalties due to CAT. The Court has ordered that the trial will commence in late
November 2004, with an estimated length of three weeks.
Licensed Product Candidates
ABT-874, a human anti-IL12 monoclonal antibody isolated and optimised by CAT in
collaboration with Abbott, and licensed by CAT to Abbott under the same 1995
agreement between CAT and Knoll Aktiengesellschaft as HUMIRA, is in Phase II
clinical trials. In June 2004, Abbott announced the initiation of a Phase II
study evaluating the potential of ABT-874 in the treatment of multiple
sclerosis, an autoimmune disease characterised by the bodys immune system
attacking the brain and spinal cord.
In July 2004, Human Genome Sciences, Inc (HGSI) announced that it had completed
enrolment in its two Phase II clinical trials of LymphoStat-B(TM) (belimumab),
a human monoclonal antibody which modulates the activities of B-lymphocytes. The
first, a double-blind, placebo-controlled multi-centre trial in 283 patients
with active rheumatoid arthritis who have failed prior therapy, will evaluate
safety, optimal dosing and efficacy of LymphoStat-B. The second is a
double-blind, placebo-controlled, multi-centre Phase II clinical trial of
LymphoStat-B in 449 patients with active systemic lupus erythematosus (SLE).
In June 2004, HGSI presented interim results of ongoing Phase I clinical trials
to evaluate the safety and pharmacology of HGS-ETR1 (previously known as
TRAIL-R1 mAb) in patients with advanced solid tumours or non-Hodgkins lymphoma
at the 40th Annual Meeting of the American Society of Clinical Oncology (ASCO)
in New Orleans, USA. The interim results demonstrate the safety and tolerability
of HGS-ETR1 and support its further evaluation in Phase II trials. HGSI plans to
initiate Phase II clinical trials in 2004.
HGSI continues to enrol patients with advanced tumours in two Phase I
open-label, dose-escalating clinical trials of HGS-ETR2 (previously known as
TRAIL-R2 mAb) and plans to complete enrolment of one of the Phase I trials in
2004.
Wyeth announced in June 2004 that it has filed an Investigational New Drug (IND)
application for MYO-029, a human monoclonal antibody discovered by CAT in
collaboration with Wyeth and licensed to Wyeth. MYO-029 neutralises the effects
of a protein called GDF-8 which is associated with reduced skeletal muscle mass,
is being studied as a potential therapy for muscle-wasting diseases, including
muscular dystrophy and sarcopenia. Wyeth is now moving forward with a Phase I
clinical trial.
People
CAT is delighted to announce the appointment of Professor Christopher Marshall
as a Non-Executive Director of CAT. He will take up his position as a
Non-Executive Director on 24 September 2004 and is expected to join CATs
Scientific Advisory Board at the same time. Professor Marshall is Director of
the Cancer Research UK Centre for Cell and Molecular Biology at the Institute of
Cancer Research London, UK and a Fellow of the Royal Society. He brings a new
perspective and scientific breadth to the Board of CAT and the Company looks
forward to working with him.
Financial Results
The financial results for the nine months ended 30 June 2004 are set out below.
The comparative figures in brackets are for the corresponding period in the
prior financial year unless otherwise stated. Commentary is included on
significant factors in the third quarter trading.
CAT made a loss after taxation for the nine months ended 30 June 2004 of #28.4
million (#26.5 million). Net cash outflow before management of liquid resources
and financing for the nine month period was #20.7 million (#19.0 million). Net
cash and liquid resources at 30 June 2004 were #101.0 million (#112.8 million).
Turnover in the nine month period was #10.1 million (#6.4 million). In the three
months to 30 June 2004, licence fees of #1.2 million were recognised as revenue,
principally licence fees released from deferred income carried forward from
prior financial years, and revenues of #0.4 million were generated from contract
research fees under collaborations with Amgen and Pfizer.
Operating costs for the nine month period amounted to #40.0 million (#38.8
million) of which research and development costs were #32.0 million (#32.3
million). External development costs were #13.8 million in the nine months to 30
June 2004 (#10.0 million), reflecting increased activity on the Trabio clinical
trials and the CAT-354 programme. The small decrease in research and development
costs between the second quarter and the third quarter reflects slightly lower
levels of external development spend.
General and administration expenses for the nine month period were #8.0 million
(#6.5 million). The increase in cost in the third quarter as compared to the
second quarter was primarily due to a rise in spend on litigation. The cost of
litigation for the nine month period was #1.5 million (#0.2 million).
During the nine month period the Group accrued interest receivable on its cash
deposits of #3.1 million (#3.5 million) reflecting the reduced level of cash and
liquid resources held in interest bearing securities during the period.
The net increase in deferred income balances in the three month period was #1.2
million. This includes the receipt of a licence fee from Genzyme which will be
recognised over the relevant future period, in accordance with CATs established
accounting policy.
CAMBRIDGE ANTIBODY TECHNOLOGY GROUP PLC
Results for the NINE MONTHS ended 30 JUNE 2004
CONSOLIDATED PROFIT AND LOSS ACCOUNT
(unaudited)
Nine months Nine months Nine months Year ended
ended ended ended 30 September
30 June 2004 30 June 2004 30 June 2003 2003
Convenience
translation
US$000 #000 #000 #000
Turnover 18,340 10,118 6,394 8,743
Direct costs (2,768) (1,527) (232) (690)
Gross profit 15,572 8,591 6,162 8,053
Research and development expenses (58,056) (32,029) (32,318) (44,981)
General and administration expenses (14,537) (8,020) (6,515) (9,196)
Operating loss (57,021) (31,458) (32,671) (46,124)
Interest receivable (net) 5,577 3,077 3,494 4,360
Loss on ordinary activities before
taxation (51,444) (28,381) (29,177) (41,764)
Tax on loss on ordinary activities - - 2,700 2,573
Loss for the financial period (51,444) (28,381) (26,477) (39,191)
Loss per share - basic and diluted
(pence) 69.6p 72.8p 107.5p
Consolidated Statement of Total Recognised Gains and Losses
Nine months Nine months Nine months Year ended
ended ended ended 30 September
30 June 2004 30 June 2004 30 June 2003 2003
Convenience
translation
US$000 #000 #000 #000
Loss for the financial period (51,444) (28,381) (26,477) (39,191)
Gain on foreign exchange translation 2,110 1,164 515 606
Total recognised losses relating to the period (49,334) (27,217) (25,962) (38,585)
The losses for all periods arise from continuing operations.
This financial information has been prepared in accordance with UK GAAP. The
dollar translations are solely for the convenience of the reader.
CAMBRIDGE ANTIBODY TECHNOLOGY GROUP PLC
Results for the NINE MONTHS ended 30 JUNE 2004
Consolidated Balance Sheet (unaudited)
As at As at As at As at
30 June 2004 30 June 2004 30 June 2003 30 September
2003
Convenience
translation
US$000 #000 #000 #000
Fixed assets
Intangible assets 11,048 6,095 7,145 6,883
Tangible assets 23,198 12,798 14,450 14,366
Investments 5,333 2,942 215 3,373
39,579 21,835 21,810 24,622
Current assets
Debtors 8,606 4,748 3,757 4,526
Short term investments 181,807 100,302 112,385 108,347
Cash at bank and in hand 5,209 2,874 1,328 1,056
195,622 107,924 117,470 113,929
Creditors
Amounts falling due within one year (24,949) (13,764) (14,097) (12,657)
Net current assets 170,673 94,160 103,373 101,272
Total assets less current liabilities 210,252 115,995 125,183 125,894
Creditors
Amounts falling due after more than one year (38,607) (21,299) (14,194) (18,152)
Net assets 171,645 94,696 110,989 107,742
Capital and reserves
Called-up share capital 7,448 4,109 3,653 3,834
Share premium account 411,060 226,779 203,688 212,883
Other reserve 24,390 13,456 13,456 13,456
Profit and loss account (271,253) (149,648) (109,808) (122,431)
Shareholders funds - all equity 171,645 94,696 110,989 107,742
This financial information has been prepared in accordance with UK GAAP. The
dollar translations are solely for the convenience of the reader.
CAMBRIDGE ANTIBODY TECHNOLOGY GROUP PLC
Results for the NINE MONTHS ended 30 JUNE 2004
Consolidated Cash Flow Statement
(unaudited) Nine months Nine months Nine months Year ended
ended ended ended 30 September
30 June 2004 30 June 2004 30 June 2003 2003
Convenience
translation
US$000 #000 #000 #000
Net cash outflow from operations (41,512) (22,902) (21,213) (35,819)
Returns on investments and servicing of
finance
Interest received 5,501 3,035 4,497 5,095
Interest element of finance leases (111) (61) (28) (46)
5,390 2,974 4,469 5,049
Taxation - - 5,337 5,210
Capital expenditure and financial
investment
Purchase of intangible fixed assets - - (2,673) (2,673)
Purchase of tangible fixed assets (1,321) (729) (4,948) (5,413)
Sale of tangible fixed assets 2 1 4 4
(1,319) (728) (7,617) (8,082)
Net cash outflow before management of
liquid resources and financing (37,441) (20,656) (19,024) (33,642)
Management of liquid resources 14,972 8,260 14,309 18,778
Financing
Issue of ordinary share capital 25,686 14,171 1,186 10,562
Proceeds from new finance lease commitment - - 1,076 1,389
Capital elements of finance lease rental
payments (468) (258) (161) (221)
25,218 13,913 2,101 11,730
Increase/(decrease) in cash 2,749 1,517 (2,614) (3,134)
This financial information has been prepared in accordance with UK GAAP. The
dollar translations are solely for the convenience of the reader.
Notes to the financial information
Accounting policies
This financial information has been prepared in accordance with the policies set
out in the statutory financial statements for the year ended 30 September 2003.
Convenience translation
The consolidated financial statements are presented in Sterling. The
consolidated financial statements as of and for the period ended 30 June 2004
are also presented in US Dollars as a convenience translation. The Dollar
amounts are presented solely for the convenience of the reader and have been
calculated using an exchange rate of #1:US$1.8126, the noon buying rate as of 30
June 2004. No representation is made that the amounts could have been or could
be converted into US Dollars at this or any other rates.
Loss per share
The loss per ordinary share and diluted loss per share are equal because share
options are only included in the calculation of diluted earnings per share if
their issue would decrease the net profit per share or increase the net loss per
share. The calculation is based on information in the table shown below.
Nine months Nine months Year ended
ended ended 30 September
30 June 2004 30 June 2003 2003
Losses (#000) 28,381 26,477 39,191
Weighted average number of shares 40,787,824 36,369,209 36,440,993
The Company had ordinary shares in issue of 41,094,936 and a total of 2,115,999
ordinary shares under option as of 30 June 2004.
Reconciliation of operating loss to operating cash outflow
Nine months Nine months Nine months Year ended
ended ended ended 30 September
30 June 2004 30 June 2004 30 June 2003 2003
Convenience
translation
US$000 #000 #000 #000
Operating loss (57,021) (31,458) (32,671) (46,124)
Depreciation charge 3,883 2,142 2,263 2,989
Amortisation of intangible fixed assets 1,428 788 788 1,050
Amounts written off fixed asset 390 215 - -
investments
Loss on disposal of fixed assets - - 94 94
Shares received from MorphoSys - - - (3,589)
Increase in debtors (219) (121) (812) (1,285)
Increase in deferred income 8,184 4,515 6,665 10,597
Increase in creditors (excluding deferred 1,843 1,017 2,460 449
income)
(41,512) (22,902) (21,213) (35,819)
Analysis and reconciliation of net funds
1 October Cash flow Exchange 30 June 2004
2003 movement
#000 #000 #000 #000
Cash at bank and in hand 1,056 1,858 (40) 2,874
Overdrafts (1,144) (341) - (1,485)
1,517 (40)
Liquid resources 107,916 (8,260) - 99,656
Net cash and liquid resources 107,828 (6,743) (40) 101,045
Finance leases (1,168) 258 - (910)
Net funds 106,660 (6,485) (40) 100,135
Liquid resources shown above is included within short term investments on the
Balance Sheet, which also includes a part of the investment in MorphoSys shares.
Reconciliation of movements in group shareholders funds
Nine months Year ended
ended 30 September
30 June 2004 2003
#000 #000
Loss for the financial period (28,381) (39,191)
Other recognised gains and losses relating to the period 1,164 606
(27,217) (38,585)
New shares issued 14,171 10,562
Net decrease in shareholders funds (13,046) (28,023)
Opening shareholders funds 107,742 135,765
Closing shareholders funds 94,696 107,742
Financial Statements
The preceding information, comprising the Consolidated Profit and Loss Account,
Consolidated Statement of Total Recognised Gains and Losses, Consolidated
Balance Sheet, Consolidated Cash Flow Statement and associated notes, does not
constitute the Companys statutory financial statements for the year ended 30
September 2003 within the meaning of section 240 of the Companies Act 1985, but
is derived from those financial statements. Results for the nine month periods
ended 30 June 2004 and 30 June 2003 have not been audited. The results for the
year ended 30 September 2003 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.
The annual report and financial statements for the year ended 30 September 2003
are available from the Corporate Communications Department at the Companys
registered office:
Cambridge Antibody Technology Group plc
Milstein Building
Granta Park
Cambridge
CB1 6GH, UK
Tel: +44 (0) 1223 471471
Quarterly financial information
Three Three Three
months months months
ended 30 ended 31 ended 31
March 2004 December
June 2004 2003
#000 #000 #000
Consolidated profit and loss account
(unaudited):
Turnover 1,650 4,650 3,818
Direct costs (4) (1,275) (248)
Gross profit 1,646 3,375 3,570
Research and development expenses (10,543) (11,066) (10,420)
General and administration expenses (2,540) (2,283) (3,197)
Operating loss (11,437) (9,974) (10,047)
Interest receivable (net) 1,024 1,070 983
Loss on ordinary activities before taxation (10,413) (8,904) (9,064)
Taxation on loss on ordinary activities - - -
Loss for the financial period (10,413) (8,904) (9,064)
Consolidated cash flow statement (unaudited):
Net cash outflow from operations (7,138) (8,355) (7,409)
Returns on investments and servicing of
finance
Interest received 798 1,032 1,205
Interest paid (18) (21) (22)
780 1,011 1,183
Taxation - - -
Capital expenditure and financial investment
Purchase of tangible fixed assets (130) (226) (373)
Sale of tangible fixed assets 1 - -
(129) (226) (373)
Net cash outflow before management of liquid
resources and financing
(6,487) (7,570) (6,599)
Management of liquid resources 7,705 5,241 (4,686)
Financing
Issue of ordinary share capital 56 235 13,880
Proceeds from new finance lease commitments - - -
Capital elements of finance lease rental payments (88) (86) (84)
(32) 149 13,796
Increase/(decrease) in cash 1,186 (2,180) 2,511
Notes to Editors
Cambridge Antibody Technology (CAT):
CAT is a biopharmaceutical company using its proprietary technologies and
capabilities in human monoclonal antibodies for drug discovery and drug
development. Based near Cambridge, UK, CAT currently employs around 270 people.
CAT is a leader in the discovery and development of human therapeutic antibodies
and has an advanced proprietary platform technology for rapidly isolating human
monoclonal antibodies using phage display and ribosome display systems. CAT has
extensive phage antibody libraries, currently incorporating more than 100
billion distinct antibodies. These libraries form the basis for the Companys
strategy to develop a portfolio of antibody-based drugs.
Four CAT human therapeutic antibody products are now at various stages of
clinical development, with one further product candidate in pre-clinical
development.
HUMIRA, the leading CAT-derived antibody, isolated and optimised in
collaboration with Abbott, has been approved for marketing as a treatment for
rheumatoid arthritis in 51 countries. Six further licensed CAT-derived human
therapeutic antibodies are in clinical development, with four further licensed
product candidates in pre-clinical development.
CAT has alliances with a number of pharmaceutical and biotechnology companies to
discover, develop and commercialise human monoclonal antibody-based products. In
particular, CAT has a broad collaboration with Genzyme for the development and
commercialisation of antibodies directed against TGFbeta, a family of proteins
associated with fibrosis and scarring. This collaboration has so far given rise
to one antibody product candidate at clinical development stage, and one at
pre-clinical development stage.
CAT has also licensed its proprietary technologies to several companies. CATs
licensees include: Abbott, Amgen, Chugai, Genzyme, Human Genome Sciences, Merck
& Co, Pfizer and Wyeth Research.
CAT is listed on the London Stock Exchange and on NASDAQ. CAT raised #41m in its
IPO in March 1997 and #93m in a secondary offering in March 2000.
Application of the Safe Harbor of the Private Securities Litigation Reform Act
of 1995: This press release contains statements about Cambridge Antibody
Technology Group plc ("CAT") that are forward looking statements. All statements
other than statements of historical facts included in this press release may be
forward looking statements within the meaning of Section 21E of the Securities
Exchange Act of 1934. These forward looking statements are based on numerous
assumptions regarding the companys present and future business strategies and
the environment in which the company will operate in the future. Certain factors
that could cause the companys actual results, performance or achievements to
differ materially from those in the forward looking statements include: market
conditions, CATs ability to enter into and maintain collaborative arrangements,
success of product candidates in clinical trials, regulatory developments and
competition. We caution investors not to place undue reliance on the forward
looking statements contained in this press release. These statements speak only
as of the date of this press release, and we undertake no obligation to update
or revise the statements.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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