RNS Number:1475V
Cambridge Antibody Tech Group PLC
09 February 2004
04/CAT/05
FOR IMMEDIATE RELEASE
07.00 GMT, 02:00 EST Monday 9 February 2004
For further information contact:
Cambridge Antibody Technology Weber Shandwick Square Mile (Europe)
Tel: +44 (0) 20 7067 0700
Tel: +44 (0) 1223 471 471
Kevin Smith
Peter Chambre, Chief Executive Officer
Rachel Lankester
John Aston, Chief Financial Officer
Rowena Gardner, Director of Corporate BMC Communications/The Trout Group (USA)
Communications
Tel: +1 212 477 9007
Brad Miles, ext 17 (media)
Brandon Lewis, ext 15 (investors)
CAMBRIDGE ANTIBODY TECHNOLOGYGROUP PLC
ANNOUNCES FIRST QUARTER FINANCIAL RESULTS
Cambridge, UK Cambridge Antibody Technology Group plc (LSE: CAT; NASDAQ: CATG)
today announces financial results for the first quarter of its financial year,
from 1 October 2003 to 31 December 2003, and an update on business since the
Preliminary Results Announcement on 17 November 2003.
Summary
* Continued progress in CAT core development programmes:
- preliminary results show primary objective of CAT-192 Phase I/II
clinical trial met: CAT-192 found to be generally safe and
well-tolerated
- enrolment complete in Phase III pivotal International clinical trial
of TrabioTM
* Further steps taken in strategyto focus investment on core programmes:
- co-development agreement with Amgen restructured on attractive terms
- co-development agreement with Elan in the fields of neurology and pain
terminated by CAT
* Extensionof manufacturing agreement with Lonza to secure supply of
clinical grade antibody drugs to the end of 2006
* Second tranche of equity investment by Genzyme
* Reduced net cash outflow before management of liquid resources and
financing: #6.6 million for the three months ended 31 December 2003
compared with #7.2 million for the three months ended 31 December 2002
* Net cash and liquid resources increased to #115.1 million at 31 December
2003 from #107.8 million at 30 September 2003
CAT Product Candidates
Enrolment is complete in the Phase III pivotal International clinical trial of
Trabio, a human anti-TGFb2 monoclonal antibody, in patients undergoing first
time surgery for glaucoma (trabeculectomy). A total of 393 patients in six
European countries and South Africa were randomised in the double-blind trial
which compares Trabio with placebo. Data from this trial are expected in early
2005 when all patients will have completed at least one year of follow-up post
surgery.
CAT and Genzyme Corp today announce preliminary results from a Phase I/II
clinical trial of CAT-192, a human anti-TGFb1 monoclonal antibody. The primary
objective of the trial was to assess the safety, tolerability and
pharmacokinetics of CAT-192 in patients suffering from diffuse systemic
sclerosis. The secondary objective was to evaluate the potential clinical
outcomes for any future trial in systemic sclerosis.
The double-blind, placebo-controlled trial enrolled 45 patients at 12 medical
centres in the US and Europe. Patients were randomised to receive one of three
dose levels of CAT-192 (0.5 mg/kg, 5 mg/kg or 10 mg/kg) or matching placebo,
given as an intravenous infusion every six weeks for four doses. Preliminary
results show that the primary objective of the trial was met; CAT-192 was
generally safe and well-tolerated at each dose level. Elimination half-life was
consistently around three weeks. There were no treatment-related serious adverse
events observed. Four patient deaths occurred during the trial (one at 0.5 mg/
kg and three at 5 mg/kg) and were determined by independent medical reviewers to
be attributable to patientsO underlying disease, and unrelated to treatment. For
the secondary objective of the trial a number of clinical endpoints and
biological markers, potentially indicative of disease progression, were
evaluated. Preliminary review of these markers indicated that disease duration
and gender played important roles in the results seen, and that the placebo
groupOs skin score did not deteriorate during the trial as anticipated. Given
these factors and the small sample size, no definitive conclusions regarding the
efficacy of CAT-192 can be drawn at this time. Additional analyses and
alternative trial designs are being evaluated.
An Investigational New Drug application for a Phase I trial in the US in
idiopathic pulmonary fibrosis (IPF) of GC-1008, a pan-specific human anti-TGFb
monoclonal antibody being developed by CAT and Genzyme, has been filed with the
US Food and Drug Administration (FDA). Discussions with the FDA are ongoing.
HUMIRATM
In January, Abbott Laboratories announced increased worldwide 2004 sales
forecasts for HUMIRATM (adalimumab), a human anti-TNFa monoclonal antibody and
the first CAT-derived antibody to receive approval for marketing. Abbott
reported that HUMIRA is now approved for sale in 37 countries and achieved full
year sales in 2003 of $280 million. Based on this performance, Abbott has raised
its sales expectations for 2004 to more than $700 million.
The legal proceedings CAT commenced against Abbott Biotechnology Limited and
Abbott GmbH in November 2003 in the High Court in London are continuing.
Other Licensed Product Candidates
LymphoStat-BTM, a human monoclonal antibody which modulates the activities of
B-lymphocytes, was isolated at CAT in collaboration with Human Genome Sciences,
Inc (HGSI) and licensed to HGSI in 2001. In January 2004, HGSI announced that it
has begun dosing patients in a Phase II clinical trial of LymphoStat-B for the
treatment of rheumatoid arthritis. The double-blind, placebo-controlled
multi-centre Phase II trial will evaluate safety, optimal dosing and efficacy of
LymphoStat-B in approximately 230 patients with active rheumatoid arthritis who
have failed prior therapy. Also, HGSI continues to enrol and dose patients in
its double-blind, placebo-controlled, multi-centre Phase II clinical trial of
LymphoStat-B in patients with active systemic lupus erythematosus. HGSI plans
to complete enrolment of both Phase II clinical trials in 2004.
HGSI has completed enrolment in its Phase I placebo-controlled, dose-escalation
clinical trial to evaluate thesafety, tolerability and pharmacokinetics of
ABthraxTM, a human anti-protective antigen monoclonal antibody isolated and
developed by HGSI from antibody libraries licensed from CAT. HGSI has announced
that it intends to submit an abstract from the trial for presentation at the
American Society of MicrobiologyOs Biodefence Meeting, scheduled for March 2004.
HGSI has stated that further development of ABthrax will depend on US government
funding.
HGSI continues with the Phase I clinical trialsto evaluate the safety and
pharmacology of HGS-ETR1 (previously known as TRAIL-R1 mAb) in patients with
advanced solid tumours and has submitted an abstract from the Phase I clinical
trials for presentation at the Annual Society of Clinical Oncologymeeting,
scheduled for June. HGSI plans to initiate Phase II clinical trials in 2004.
In the Phase I open-label, dose-escalating clinical trial of HGS-ETR2
(previously known as TRAIL-R2 mAb), HGSI continues to enrol patients with
advanced tumours. Additionally, HGSI has recently received clearance from the
FDA to commence a Phase I clinical trial in the US. HGSI plans to complete
enrolment of both Phase I trials in 2004.
There are four product candidates at pre-clinical development stage at CATOs
collaborators.
Discovery Stage Programmes
There are ongoing research programmes to 14 distinct molecular targets at CAT.
Half are funded or co-funded by CAT and half are funded by CATOs licensees.
In December CAT restructured its agreement with Amgen, with Amgen taking over
responsibility for the further development and marketing of the therapeutic
antibody candidates isolated by CAT against two targets identified by Amgen and
covered by an earlier collaboration agreement between CAT and Immunex. In
return, CAT receives from Amgen an initial fee and potential milestone payments
and royalties on future sales. This agreement allows CAT to focus its investment
on a smaller number of core programmes, while retaining significant interest in
the success of these two antibody candidates.
After three years, CAT has exercised its right to terminate its agreement with
Elan, effective from 21 February 2004. The collaboration involved research on a
number of targets. Terminating this exclusive agreement will allow CAT to
collaborate with third parties in the fields of neurology and pain. The
termination of the existing agreement does not preclude future collaboration
with Elan.
In December, the research collaboration with Pfizer was extended for a further
six months to 30 May 2004.
Operations
In January CAT and Lonza announced the extension of their November 2001
agreement, confirming that Lonza Biologics will manufacture and supply clinical
grade antibodydrugs to CAT through to the end of 2006. This will enable CAT to
plan further ahead with confidence and will guarantee that CAT and its
collaborators have access to LonzaOs world-class manufacturing capability at
production scale (up to 2,000L), forboth ongoing programmes and future
projects, in a cost-effective way.
Financial Results
A review of the financial results for the three months ended 31 December 2003 is
set out below. The comparative figures in brackets are for the corresponding
period in the prior financial year unless otherwise stated.
CAT made a loss after taxation for the three months ended 31 December 2003 of
#9.1 million (2002: #10.5 million). Net cash outflow before management of liquid
resources and financing for the period was #6.6 million (2002: #7.2 million).
Revenue in the period was #3.8 million (2002: #1.4 million). Royalty income of
#0.7 million was recognised as revenue in the quarter representing the amount
received from Abbott in respect of HUMIRA for sales through to 30 June 2003.
Licence fees of #1.1 million and milestone payments of #1.3 million were
recognised in the period. Four technical milestone payments were received from
Pfizer in December 2003. A proportion of a clinical milestone received from
Abbott in the last financial year was released to revenue, having been offset
against the first royalty payment made by Abbott. Revenues of #0.6 million were
generated from contract research fees under collaborations with Pfizer, Wyeth
Research and Merck & Co., Inc. The research services being performed for Wyeth
Research were completed during the period.
Direct costs for the three months ended 31 December 2003 were #0.2 million,
reflecting royalties due to the Medical Research Council and other licensors in
respect of the royalties CAT receives on product sales.
Operating costs for the period amounted to #13.6 million (2002: #13.2 million).
Research and development expenses decreased from #11.2 million for the three
months ended 31 December 2002 to #10.4 million for the three months ended 31
December 2003. Research and development costs for the three months ended 31
December 2002 included the one-off cost of a cross-licensing arrangement with
Xoma for antibody-related technologies. External development costs have risen
significantly from #2.5 million in the three months ended 31 December 2002 to
#4.7 million in the three months ended 31 December 2003, reflecting activity on
clinical trials, particularly Trabio.
General and administration expenses increased from #2.0 million for the three
months ended 31 December 2002 to #3.2 million for the three months ended 31
December 2003. The main reason for this increase is a non-cash charge arising
from the retranslation of CATOs trading balances with its US subsidiary, Aptein
Inc., as over the relevant period there has been a material depreciation in the
value of the US Dollar compared to Sterling.
During the period the Group accrued interest receivable on its cash deposits of
#1.0 million (2002: #1.3 million) reflecting the reduced level of cash and
liquid resources held in interest bearing securities and the lower interest
rates available.
Genzyme has increased its equity stake in CAT through a subscription of #22.9
million for 4.3 million shares. The subscription for shares occurred in two
tranches, the first of which occurred during the previous financial year. The
second tranche was for 2.5 million shares with a value of #13.3 million, issued
following shareholder approval at the EGM held in October 2003.
As a result of the Genzyme subscription, net cash and liquid resources at 31
December 2003 increased to #115.1 million from #107.8 million at 30 September
2003.
CAMBRIDGE ANTIBODY TECHNOLOGY GROUP PLC
PRELIMINARY STATEMENT OF RESULTS FOR
THE THREE MONTHS ENDED 31 DECEMBER 2003
CONSOLIDATED PROFIT AND LOSS ACCOUNT
(unaudited)
Three months Three months Three months Year
ended ended ended ended
31 December 31 December 31 December 30 September
2003 2003 2002 2003
Convenience
translation
US$'000 #'000 #'000 #'000
Turnover 6,812 3,818 1,405 8,743
Direct costs (442) (248) (9) (690)
Gross profit 6,370 3,570 1,396 8,053
Research and development expenses (18,591) (10,420) (11,234) (44,981)
General and administration expenses (5,704) (3,197) (2,008) (9,196)
Operating loss (17,925) (10,047) (11,846) (46,124)
Interest receivable (net) 1,754 983 1,306 4,360
Loss on ordinary activities before (16,171) (9,064) (10,540) (41,764)
taxation
Taxation on loss on ordinary - - - 2,573
activities
Loss for the financial period (16,171) (9,064) (10,540) (39,191)
Loss per share - basic and diluted 22.5p 29.1p 107.5p
(pence)
Consolidated Statement of Total Recognised Gains and Losses
Three months Three months Three Year
ended ended months ended
31 December 31 December ended 30 September
2003 2003 31 December 2003
2002
Convenience
translation
US$'000 #'000 #'000 #'000
Loss for the financial period (16,171) (9,064) (10,540) (39,191)
Gain on foreign exchange translation 1,675 939 256 606
Total recognised losses relating to the (14,496) (8,125) (10,284) (38,585)
period
The losses for all periods arise from continuing operations.
This financial information has been prepared in accordance with UK GAAP. The
dollar translations are solely for the convenience of the reader.
CAMBRIDGE ANTIBODY TECHNOLOGY GROUP PLC
PRELIMINARY STATEMENT OF RESULTS FOR
THE THREE MONTHS ENDED 31 DECEMBER 2003
Consolidated Balance Sheet
(unaudited) As at As at As at As at
31 December 31 December 31 December 30 September
2003 2003 2002 2003
Convenience
translation
US$'000 #'000 #'000 #'000
Fixed assets
Intangible assets 11,811 6,620 7,671 6,883
Tangible fixed assets 24,618 13,798 13,907 14,366
Investments 6,018 3,373 215 3,373
42,447 23,791 21,793 24,622
Current assets
Debtors 11,622 6,514 5,104 4,526
Short term investments 201,673 113,033 116,449 108,347
Cash at bank and in hand 6,473 3,628 7,645 1,056
219,768 123,175 129,198 113,929
Creditors
Amounts falling due within one year (23,550) (13,199) (16,024) (12,657)
Net current assets 196,218 109,976 113,174 101,272
Total assets less current liabilities 238,665 133,767 134,967 125,894
Creditors
Amounts falling due after more than one year (36,165) (20,270) (8,798) (18,152)
Net assets 202,500 113,497 126,169 107,742
Capital and reserves
Called-up sharecapital 7,313 4,099 3,635 3,834
Share premium account 404,118 226,498 203,208 212,883
Other reserve 24,008 13,456 13,456 13,456
Profit and loss account (232,939) (130,556) (94,130) (122,431)
ShareholdersO funds - all equity 202,500 113,497 126,169 107,742
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
PRELIMINARY STATEMENT OF RESULTS FOR
THE THREE MONTHS ENDED 31 DECEMBER 2003
Consolidated Cash Flow Statement
(unaudited)
Three months Three months Three months Year
ended ended ended ended
31 December 31 December 31 December 30 September
2003 2003 2002 2003
Convenience
translation
US$'000 #'000 #'000 #'000
Net cash outflow from operations (13,219) (7,409) (5,414) (35,819)
Returns on investments and servicing of
finance
Interest received 2,150 1,205 1,048 5,095
Interest element of finance leases (39) (22) - (46)
2,111 1,183 1,048 5,049
Taxation - - 2,637 5,210
Capital expenditure and financial
investment
Purchase of intangible fixed assets - - (2,673) (2,673)
Purchase of tangible fixed assets (666) (373) (2,826) (5,413)
Sale of tangible fixed assets - - - 4
(666) (373) (5,499) (8,082)
Net cash outflow before management of (11,774) (6,599) (7,228) (33,642)
liquid resources and financing
Management of liquid resources (8,361) (4,686) 10,245 18,778
Financing
Issue of ordinary share capital 24,765 13,880 688 10,562
Proceeds from new finance lease - - 504 1,389
commitment
Capital elements of finance lease rental (150) (84) (36) (221)
payments
24,615 13,796 1,156 11,730
Increase/(decrease) in cash 4,480 2,511 4,173 (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 31 December
2003 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$1.7842, the noon buying rate as of 31
December 2003. No representation is made that the amounts could have been or
could be converted into US Dollars at this or any other rates.
Loss per share
The loss per ordinary share and diluted loss per share are equal because share
options are only included in the calculation of diluted earnings per share if
their issue would decrease the net profit per share or increase the net loss per
share. The calculation is based on the following for the three months ended 31
December 2003, the three months ended 31 December 2002 and the year ended 30
September 2003 respectively: losses of #9,064,000, #10,540,000, and #39,191,000;
weighted average number of shares in issue of 40,270,246, 36,260,545 and
36,440,993. The Company had ordinary shares in issue of 40,991,338 and a total
of 1,967,118 ordinary shares under option as of 31 December 2003.
Reconciliation of operating loss to operating cash outflow
Three months Three months Three months Year
ended ended ended ended
31 December 31 December 31 December 30 September
2003 2003 2002 2003
Convenience
translation
US$'000 #'000 #'000 #'000
Operating loss (17,925) (10,047) (11,846) (46,124)
Depreciation charge 1,345 754 726 2,989
Amortisation of intangible fixed assets 469 263 262 1,050
Loss on disposal of fixed assets - - 7 94
Shares received from MorphoSys - - - (3,589)
Increase in debtors (3,909) (2,191) (926) (1,285)
Increase in deferred income 4,500 2,522 121 10,597
Increase in creditors (excluding deferred 2,301 1,290 6,242 449
income)
(13,219) (7,409) (5,414) (35,819)
Analysis and reconciliation of net funds
1 October Cash flow Exchange 31 December
movement 2003
2003
#'000 #'000 #'000 #'000
Cash at bankand in hand 1,056 2,540 32 3,628
Overdrafts (1,144) (29) - (1,173)
2,511 32
Liquid resources 107,916 4,686 - 112,602
Net cash and liquid resources 107,828 7,197 32 115,057
Finance leases (1,168) 84 - (1,084)
Net funds 106,660 7,281 32 113,973
Three months Year
ended ended
31 December 30 September
2003 2003
#'000 #'000
Increase/(decrease) in cash in the period 2,511 (3,134)
Increase/(decrease) in liquid resources 4,686 (18,778)
Decrease/(increase) in lease financing 84 (1,168)
Change in net funds resulting from cash flows 7,281 (23,080)
Exchange movement 32 (35)
Movement in net funds in period 7,313(23,115)
Net funds at 1 October 2003 106,660 129,775
Net funds at 31 December 2003 113,973 106,660
Reconciliation of movements in group shareholdersO funds
Three months Year
ended ended
31 December 30 September
2003 2003
#'000 #'000
Loss for the financial period (9,064) (39,191)
Other recognised gains and losses relating to the period 939 606
(8,125) (38,585)
New shares issued 13,880 10,562
Net increase/(decrease) in shareholdersO funds 5,755 (28,023)
Opening shareholdersO funds 107,742 135,765
Closing shareholdersO funds 113,497 107,742
Financial Statements
The preceding information, comprising the Consolidated Profit and Loss Account,
Consolidated Statement of Total Recognised Gains and Losses, Consolidated
Balance Street, Consolidated Cash Flow Statement and associated notes, does not
constitute the CompanyOs 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 three month periods
ended 31 December 2003 and 31 December 2002 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 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 CompanyOs
registered office:
Cambridge Antibody Technology Group plc
Milstein Building
Granta Park
Cambridge
CB1 6GH, UK
Tel: +44 (0) 1223 471471
-ENDS-
Notes to Editors
Cambridge Antibody Technology (CAT):
CAT is a UK-based biotechnology company using its proprietary technologies and
capabilities in human monoclonal antibodies for drug discovery and drug
development. Based near Cambridge, England, 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 CompanyOs
strategy to develop a portfolio of antibody-based drugs.
Three CAT human therapeutic antibody products are now in clinical development,
with two further product candidates in pre-clinical development.
HUMIRATM, the leading CAT-derived antibody, isolated and optimised in
collaboration with Abbott, has been approved by the US Food and Drug
Administration for marketing in the US and by the European Commission for
marketing in the EU as a treatment for rheumatoid arthritis.
Five further licensed CAT-derived human therapeutic antibodies are in clinical
development, with three 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 TGFb, 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. CATOs
licensees include: Abbott, Amgen, Chugai, 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 companyOs
present and future business
strategies and the environment in which the company will operate in the future.
Certain factors that could cause the companyOs actual results, performance or
achievements to differ materially from those in the forward looking statements
include: market conditions, CATOs 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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