RNS Number:8315K
Antisoma PLC
08 May 2003
Antisoma plc reports Q3 results
8 May 2003, London, UK: Antisoma plc (LSE:ASM, NASD-E:ASOM), the UK-based
biotechnology company developing novel anti-cancer drugs, today announces its
results for the three months ended 31 March 2003.
Announced today
* New forecast from safety committee points to completion of R1549
(formerly Pemtumomab) pivotal ovarian cancer study between February and
August 2004
* Third phase I study on AS1404 (DMXAA) starts in New Zealand
* Patents granted for R1550 (previously Therex) and caspase enzymes
* Patent rights to RGD peptides out-licensed to Amersham
Highlights
* Completion of agreements on strategic alliance with Roche
* Cash and cash equivalents as at 31 March 2003 of #34.9 million (31
December 2002: #37.6 million)
* Revenues increased to #4.2 million for the quarter from #0.41 million
in the same period last year
* Operating loss reduced to #0.09 million for the quarter from #3.6
million in the same period last year
* Positive data presented for AS1406 in breast cancer and lymphoma
* Nigel Courtenay-Luck promoted to Chief Scientific Officer
Commenting on the results, Dr Barry Price, Chairman of Antisoma, said: "Today's
results demonstrate the clear financial benefits from the Company's agreement
with Roche. Antisoma remains fully focused on driving its pipeline forward. The
latest prediction for completion of the phase III trial of R1549 in ovarian
cancer is encouraging since it suggests that we may be only around 12 months
away from having the results of that very important study."
For further information, please visit the Company's web site at www.antisoma.com
or contact:
Antisoma plc Tel: +44 (0)20 8799 8200
Raymond Spencer, Chief Financial Officer
Glyn Edwards, Chief Executive Officer
Financial Dynamics
Jonathan Birt/Ben Atwell Tel: +44 (0)20 7831 8331
Except for the historical information presented, certain matters discussed in
this statement are forward looking statements that are subject to a number of
risks and uncertainties that could cause actual results to differ materially
from results, performance or achievements expressed or implied by such
statements. These risks and uncertainties may be associated with product
discovery and development, including statements regarding the company's clinical
development programmes, the expected timing of clinical trials and regulatory
filings. Such statements are based on management's current expectations, but
actual results may differ materially.
Chairman's report
This has been an important quarter for the Company, during which the benefits of
our alliance with Roche have begun to flow through in both financial and
practical terms. Most importantly, however, we have continued to work hard to
advance our pipeline at all stages and to look at a number of opportunities for
in-licensing new products.
R1549 (formerly Pemtumomab)
We have announced today a refined prediction of the completion date for our
pivotal phase III trial (SMART) of R1549 in ovarian cancer. This is the latest
in a series of predictions made by the trial's independent Data Safety
Monitoring Committee (DSMC). The predictions are based on statistical modelling
using blinded data from the trial, and indicate when the trial is most likely to
finish and the range of possible completion dates. In November 2002, we were
informed that the peak likelihood for completion lay in July 2004, consistent
with our previously stated expectation of H2 2004. The DSMC's latest prediction
suggests a slightly earlier completion date, with the peak likelihood in April
2004 and 95% confidence that the date will fall between February and August
2004. The expected timing for the interim analysis has also been refined; this
is likely to take place during Q3 of this year (previous guidance was H2). These
refinements reflect the increasing accuracy of the predictions as the end of the
trial draws nearer. The new predictions for the study's completion fall within
the range of the November prediction and the previous one, suggesting that the
assumptions in the statistical models are still correct. At this stage there is
still some potential for changes in the expected completion date with further
predictions from the DSMC. Along with the current predictions, the DSMC has
reported that there are no safety data or other concerns that warrant changes in
the conduct of the study.
SMART (Study of Monoclonal Antibody Radioimmuno-Therapy) is one of four studies
underway on R1549. We are conducting two other ovarian cancer trials, MIDAS (Mab
Imaging and Dosimetry Assessment Study) and TOPDOC (Treatment of Peritoneal
Disease in Ovarian Cancer). MIDAS is a biodistribution study while TOPDOC will
provide additional data on the activity and tolerability of R1549. TOPDOC
includes a cohort of patients with 'minimal residual disease' following surgery
and chemotherapy. These patients still have some visible tumour remaining after
standard treatment, in contrast to the patients in previous studies who were in
complete remission (having no visible disease) after surgery and chemotherapy.
Both MIDAS and TOPDOC will contribute to the enlargement of the safety database
for R1549. The fourth study is a pilot phase II study in gastric cancer.
Preliminary results were reported during 2002 and final results will be
available following the completion of the study later this year.
AS1404 (DMXAA)
We have also announced today that screening of patients has started for our new
phase I study of AS1404 (DMXAA). This small study is being conducted in New
Zealand and will enrol around 12 patients with a variety of different solid
tumours. The aim of the study is to define appropriate doses for use in the
planned phase II programme.
AS1406 (formerly TheraNase)
Last week the first animal data were presented on AS1406 (formerly TheraNase),
which is the subject of a Collaborative Research and Development Agreement with
the US National Institutes of Health. The work was conducted in the laboratory
of Prof Susanna Rybak at the National Cancer Institute and showed encouraging
anti-tumour effects in both breast and lymphoma models.
Management developments
We recently announced the promotion of Dr Nigel Courtenay-Luck to Chief
Scientific Officer. Nigel continues to lead our preclinical operations but will
also now play a greater role in the assessment of new in-licensing opportunities
and the expansion of our network of collaborators. These areas are critical to
the successful operation of our business model.
Patent and licensing developments
We have recently been granted European patents for R1550 (huHMFG1; formerly
Therex) and for the caspase enzymes under investigation in our targeted
apoptosis programme. Meanwhile, we have signed an agreement with Amersham
to provide them with a non-exclusive license to develop RGD-containing peptides
under our relevant European and US patents. This is non-core technology that is
no longer under development at Antisoma.
Financial Review
Revenue Recognition
Following the formation of our alliance in November 2002, we received from Roche
non-refundable upfront payments totalling $37 million (#23.15 million) in return
for rights to our four clinical products and an option on new oncology compounds
entering trials over a five-year period. $35 million was received by 31 December
2002 and $2 million was received in the quarter ended 31 March 2003. These
upfront payments are allocated to the various products in accordance with the
terms of the contract and will be recognised as revenues over the estimated
period for completion of the relevant phase of clinical development for each
product.
Total revenues recognised from these upfront payments for the current quarter
are #2.3 million. It is expected that these quarterly revenues will continue at
the same level until 31 December 2004, falling thereafter.
In addition to the upfront payments, Roche will make payments equivalent to the
costs incurred by Antisoma in the continued development of R1549 and R1550.
These amounts are payable quarterly in arrears but will be recognised in the
same quarter as the expenditure to which they relate.
Results of operations - three months ended 31 March 2003
Revenue in the quarter increased to #4.2 million from #2.5 million in the
quarter ended 31 December 2002 and #0.4 million in the quarter ended 31 March
2002. #2.3 million of revenue arises from the recognition of a part of the $37m
upfront payments received from Roche and #1.9 million accrued in relation to the
development of R1549 (formerly Pemtumomab) and R1550 (formerly Therex) for the
quarter. Net operating expenses were #4.3 million, #4.4 million and #4.0 million
for the quarters ended 31 March 2003, 31 December 2002 and 31 March 2002. These
include research and development spending of #3.1 million, #3.4 million and #3.2
million, respectively, and administrative expenses of #1.2m, #1.0m and #0.8m,
respectively. Administrative expenses for the quarter have increased as a result
of costs associated with the completion of the Roche agreement. Total research
and development spending has remained steady as we continue to make progress on
each of the product candidates in the development pipeline. The increased
revenues flowing from the agreement with Roche together with maintained levels
of expenditure on research and development have resulted in operating losses
that are significantly lower at #93,000 from #1.9 million in the quarter ended
31 December 2002 and #3.6 million in the quarter ended 31 March 2002. Interest
income has increased as a result of higher cash balances to #350,000 from
#148,000 for the quarter ended 31 December 2002 and #26,000 for the quarter
ended 31 March 2002. Net profit for the period was #0.2 million (#0.65 million
loss for the quarter ended 31 December 2002; #3.6 million loss for the quarter
ended 31 March 2002). Research and development expenditure is expected to
increase as the clinical programmes for R1550, AS1404 (DMXAA) and AS1405
(formerly AngioMab) commence during this year.
Results of operations - nine months ended 31 March 2003
Revenues for the nine months ended 31 March 2003 totalled #7.1 million (9 months
ended 31 March 2002: #1.5 million), representing #1.3 million (2002: #1.5
million) of revenue recognised from the now terminated Development and Licence
Agreement with Abbott together with #5.8 million (#nil) from Roche. Operating
losses for the nine months ended 31 March 2003 fell to #5.2 million (2002: #9.9
million) and net losses fell to #3.4 million (2002: #9.7 million) as a result of
the increased revenues. Net operating expenses were #12.3 million (2002: #11.3
million) and included research and development expenses of #9.2 million (2002:
#8.7 million).
Liquidity and capital resources
Cash at bank and held in short-term investments totalled #34.9 million at 31
March 2003, #37.6 million at 31 December 2002, #18.9 million at 30 June 2002 and
#1.1 million at 31 March 2002. In the quarter ended 31 March 2003 Antisoma
received additional non-refundable upfront payments for the purchase of product
rights totalling $2 million, which were converted into #1.25 million at an
exchange rate of #1= $1.598.
Of the #23.1 million non-refundable upfront payments received, #3.0 million has
been recognised as revenue since inception of the agreement. The balance of
#20.1 million is shown as deferred revenue within creditors falling due within
one year and after more than one year and will be released to revenue as
described above in Revenue Recognition.
In the quarter Antisoma issued 20,733,240 ordinary 1p shares to Roche. The
payment for these shares of #4.15 million was received in the quarter ended 31
December 2002, and hence this amount was transferred during the quarter from
creditors to called-up share capital (#0.21 million) and the share premium
account (#3.94 million).
Net cash outflow from operating activities for the quarter was #7.1 million
(quarter ended 31 March 2002: #4.1 million outflow; quarter ended 31 December
2002: #20.9m inflow). Net cash outflow for the quarter reflects the increase in
debtors and reduction in creditors from 31 December 2002 to 31 March 2003 as
described below. The cash inflow from operating activities for the nine-month
period to 31 March 2003 was #10.3 million (2002: #7.8 million outflow).
Debtors have increased to #3.6 million (31 March 2002: #0.9 million; 31 December
2002: #1.6 million) due primarily to the accrual of amounts due from Roche
relating to the development of R1550 and R1549.
Creditors have increased to #22.9 million from #5.5 million as at 31 March 2002,
largely as a result of the non-refundable deferred revenue relating to the
upfront payments received from Roche. This is split between creditors falling
due within one year (#11.9 million) and creditors falling due after more than
one year (#11.0 million). Creditors have fallen from #28.0 million as at 31
December 2002 following the issue of ordinary shares and recognition as revenue
of part of the upfront payments received from Roche.
Loss per share
Earnings per share for the quarter are 0.1p compared to a loss per share of 3.7p
(restated to take account of the bonus element of the Rights Issue) for the
quarter ended 31 March 2002 and loss per share of 0.3p in the quarter ended 31
December 2002. Loss per share has decreased from 10.1p (restated to take account
of the bonus element of the Rights Issue) in the nine months ended 31 March 2002
to 1.6p in the nine months ended 31 March 2003.
Dr Barry Price
Chairman, 8 May 2003
Consolidated profit and loss account
for the nine months ended 31 March 2003
9 months 9 months 3 months Year
ended ended ended ended
31 Mar 31 Mar 31 Mar 30 June
2003 2002 2003 2002
unaudited unaudited unaudited audited
#'000 #'000 #'000 #'000
Revenue 7,097 1,482 4,215 2,176
Operating expenses (12,268) (11,347) (4,308) (15,738)
______ ______ ______ ______
Operating loss (5,171) (9,865) (93) (13,562)
Interest receivable 677 202 350 382
Interest payable - (9) - (11)
______ ______ ______ ______
(Loss)/profit on ordinary
activities before taxation (4,494) (9,672) 257 (13,191)
Tax on ordinary activities 1,098 - - -
______ ______ ______ ______
(Loss)/profit on ordinary
activities after taxation (3,396) (9,672) 257 (13,191)
______ ______ ______ ______
(Loss)/earnings per 1p share
Basic and diluted (1.6p) (10.1p)* 0.1p (10.8p)
______ ______ ______ ______
Weighted average number
of shares (000's) 213,159 95,642 228,066 122,123
______ ______ ______ ______
*Loss per share and weighted average number of shares for the nine months ended
31 March 2002 have been restated to take account of the bonus element of the
Rights Issue. The bonus arises because the rights were issued at a discount to
market price.
Consolidated balance sheet
at 31 March 2003
31 Mar 31 Mar 30 June
2003 2002 2002
unaudited unaudited audited
#'000 #'000 #'000
Fixed assets 284 448 230
______ ______ ______
Current assets
Debtors 3,564 870 898
Short term investments 33,459 710 17,959
Cash at bank and in hand 1,476 426 920
______ ______ ______
38,499 2,006 19,777
Creditors: amounts falling due within
one year (11,895) (5,531) (4,866)
______ ______ ______
Net current assets/(liabilities) 26,604 (3,525) 14,911
______ ______ ______
Creditors: amounts falling due after
more than one year (10,995) - -
______ ______ ______
Net assets/(liabilities) 15,893 (3,077) 15,141
______ ______ ______
Capital and reserves
Called up share capital 6,613 5,221 6,405
Share premium account 55,952 31,460 52,013
Other reserves 4,300 4,300 4,300
Profit and loss account (50,972) (44,058) (47,577)
______ ______ ______
Total shareholders' funds/(deficit) 15,893 (3,077) 15,141
______ ______ ______
Shareholders' funds/(deficit) analysed as:
Equity shareholders' funds 11,561 (7,409) 10,809
Non-equity shareholders' funds 4,332 4,332 4,332
______ ______ ______
15,893 (3,077) 15,141
______ ______ ______
Consolidated cash flow statement
for the nine months ended 31 March 2003
9 months 9 months 3 months Year
ended ended ended ended
31 Mar 31 Mar 31 Mar 30 June
2003 2002 2003 2002
unaudited unaudited unaudited audited
#'000 #'000 #'000 #'000
Net cash inflow/
(outflow) from
operating
activities 10,346 (7,786) (7,058) (11,837)
______ ______ ______ ______
Returns on investments
and servicing of finance
Interest received 651 291 264 363
Interest paid on
finance leases - (9) - (11)
______ ______ ______ ______
Net cash inflow from
returns on investments
and servicing of
finance 651 282 264 352
______ ______ ______ ______
Net cash inflow
from taxation 1,098 - - -
______ ______ ______ ______
Capital expenditure
and financial investment
Purchase of tangible
fixed assets (186) (35) (59) (52)
Sale of tangible
fixed assets - 3 - 7
Purchase of intangible
fixed assets - (397) - (397)
______ ______ ______ ______
(186) (429) (59) (442)
______ ______ ______ ______
Net cash inflow/(outflow)
before management of
liquid resources and
financing 11,909 (7,933) (6,853) (11,927)
______ ______ ______ ______
Management of liquid
resources
Sale/(purchase)
of current asset
investments (15,500) 7,500 (11,999) (9,749)
______ ______ ______ ______
Financing
Issue of shares 4,147 9 4,147 23,704
Expenses paid in
connection with
share issues - (8) - (1,965)
Repayment of
principal under
finance leases - (18) - (19)
______ ______ ______ ______
4,147 (17) 4,147 21,720
______ ______ ______ ______
Increase/(decrease)
in cash 556 (450) (14,705) 44
______ ______ ______ ______
Notes to the financial statements
1. Basis of reporting
The quarterly financial statements have been prepared in accordance with UK
Generally Accepted Accounting Principles ("UK GAAP") on the basis of the
accounting policies set out in the Group's 2002 statutory accounts. The
statements were approved by the Board of Directors on 6 May 2003 and are
unaudited.
The financial information contained in this announcement does not constitute
statutory accounts within the meaning of Section 240 of the Companies Act 1985.
The figures for the year ended 30 June 2002 have been extracted from the
statutory accounts which have been filed with the Registrar of Companies and
which are available on request from the Company Secretary Antisoma plc, West
Africa House, Hanger Lane, Ealing, London W5 3QR. The auditors' report on those
accounts was unqualified and did not contain any statement under section 237(2)
or section 237(3) of the Companies Act 1985.
2. Operating expenses
9 months 9 months 3 months Year
ended ended ended ended
31 Mar 31 Mar 31 Mar 30 June
2003 2002 2003 2002
unaudited unaudited unaudited audited
#'000 #'000 #'000 #'000
Administrative
expenses 3,098 2,684 1,188 3,837
Research and
development 9,170 8,663 3,120 11,901
______ ______ ______ ______
Operating expenses 12,268 11,347 4,308 15,738
______ ______ ______ ______
3. Reconciliation to International Financial Reporting Standards
The Company's consolidated quarterly statement has been prepared under UK GAAP
which differs in certain respects from International Financial Reporting
Standards ("IFRS"). The principal differences between UK GAAP and IFRS that
affect the Group are set out below.
Preference Shares
The Company's preference shares may be settled using equity shares, with
the number of equity shares varying in such a way that the fair value of the
shares that would be issued would be equal to the obligation. These shares are
classified as non-equity shares under UK GAAP, but are classified as liabilities
under IFRS. The effect of this difference is that, under IFRS, shareholders'
equity is #4,332,000 lower than under UK GAAP in each financial period
presented, i.e. shareholders' equity under IFRS is #11,561,000 at 31 March 2003,
(#7,409,000) at 31 March 2002 and #10,809,000 at 30 June 2002. There is no
impact on the loss for any of the years presented.
Cash flow statement
Under UK GAAP, cash does not include short term deposits and investments which
cannot be withdrawn without notice and without incurring a penalty. Such items
are shown as short term investments. Under IFRS, deposits with a maturity of
three months or less at inception and which are readily convertible to a known
amount of cash, are included as cash and cash equivalents. Additionally, IFRS
requires only three categories of cash flow activity to be reported: operating,
investing and financing. The table below sets out the effect of differences
between UK GAAP and IFRS and provides the relevant disclosures required.
Cash flow statement
9 months 9 months 3 months Year
ended ended ended ended
31 Mar 31 Mar 31 Mar 30 June
2003 2002 2003 2002
unaudited unaudited unaudited audited
#'000s #'000s #'000s #'000s
Under IFRS:
Operating
cash flows 11,444 (7,786) (7,058) (11,837)
_______ _______ _______ _______
Investing
cash flows (3,686) (4,017) (13,558) (9,691)
_______ _______ _______ _______
Financing
cash flows 4,798 265 4,411 22,072
_______ _______ _______ _______
Changes in cash
under UK GAAP 556 (450) (14,705) 44
Adjustments for
cash equivalents 12,000 (3,000) (1,500) 500
_______ _______ _______ _______
Changes in cash
and cash
equivalents
under IFRS 12,556 (3,450) (16,205) 544
_______ _______ _______ _______
Cash and short term deposits
31 Mar 31 Mar 30 June
2003 2002 2002
unaudited unaudited audited
#'000 #'000 #'000
Cash and cash equivalents under IFRS 17,186 636 4,630
Adjustment for cash equivalents (15,710) (210) (3,710)
_______ _______ _______
Cash under UK GAAP 1,476 426 920
_______ _______ _______
Short term deposits under IFRS 17,749 500 14,249
Deposits qualifying as cash equivalents
under IFRS 15,710 210 3,710
_______ _______ _______
Short term deposits under UK GAAP 33,459 710 17,959
_______ _______ _______
Notes to Editors
Antisoma
Based in London, UK, Antisoma is a biopharmaceutical company that develops novel
products for the treatment of cancer. The Company fills its development pipeline
by acquiring promising new product candidates from internationally recognised
academic or cancer research institutions. Its core activity is the pre-clinical
and clinical development of these drug candidates. Antisoma forms partnerships
with pharmaceutical companies to bring its products to market. In November 2002,
Antisoma signed a ground-breaking collaboration agreement with Roche to develop
and commercialise products from Antisoma's pipeline. Visit www.antisoma.com for
further information about Antisoma.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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