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Antisoma PLC (~292)

  Print      Mail a friend       Annual reports

Thursday 18 September, 2003

Antisoma PLC

Final Results

Antisoma PLC
18 September 2003

         Antisoma's preliminary results for the year ended 30 June 2003

18 September 2003, London, UK: Antisoma plc (LSE: ASM), the biopharmaceutical
company specialising in novel anti-cancer drugs, today announces its preliminary
results for the year ended 30 June 2003.

Highlights - a year of transformation

Ground-breaking alliance formed with Roche

     • Injection of £27.3 million cash and reduced cash burn
     • Potential for future milestone and royalty payments
     • Clear route to market established for products

Existing pipeline advanced

     • Lead product R1549 close to completing pivotal efficacy study
     • Broad development of R1550 begun with breast cancer study

Pipeline strengthened by new addition

     • Licensing of telomerase inhibitor programme from Cancer Research
       Technology Ltd (in September 2003)

Financial highlights

     • Full-year net loss reduced significantly to £3.3 million (2002:
       £13.2 million)
     • Revenues increased substantially to £11.8 million (2002: £2.2
     • Cash and cash equivalents at 30 June 2003 of £34.0 million (2002:
       £18.9 million)

Commenting on the results, Glyn Edwards, Chief Executive Officer of Antisoma,
said: 'Antisoma has achieved a step change in its position over the past 12
months. Formation of a broad strategic alliance with Roche has opened up a clear
route to market for our products and greatly improved our financial position,
leaving us well placed to exploit our maturing pipeline and to build on our
proven track record as a seeker and developer of innovative approaches to the
treatment of cancer. We are now only months away from knowing the result of our
pivotal study of R1549 in ovarian cancer.'


  Antisoma plc                                      Tel: +44 (0)20 8799 8200
  Glyn Edwards
  Chief Executive Officer
  Raymond Spencer, Chief Financial Officer

  Financial Dynamics                                Tel: +44 (0)20 7831 3113
  Jonathan Birt

The full text of Antisoma's annual report will be available on the Company
website from 30 September 2003.

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.

Joint Chief Executive and Chairman's Statement

Antisoma has emerged from the past year in the strongest and most promising
position since its inception. In the 12 months to the end of June we made
significant progress on many fronts: finding a major corporate partner to
commercialise our products, building a solid financial position and keeping a
tight control of our costs. Most importantly, we achieved all this while
continuing the key task of moving our product pipeline forward. We are now very
close to completing the pivotal study for our lead product, R1549 (formerly
Pemtumomab), in ovarian cancer.

The climate in the biotechnology sector has remained tough this year,
particularly with regard to fundings and flotations. The companies most likely
to succeed in this environment are those with a broad product pipeline, a clear
business strategy and solid finances. The Directors believe that our
achievements over the past year take Antisoma a long way towards reaching these

Partnership with Roche

In November 2002, we announced the formation of a ground-breaking strategic
alliance with Roche, one of the world's leading companies in the cancer area.
The alliance applies the development, manufacturing and commercial capabilities
of Roche to facilitate the rapid commercialisation of Antisoma's products. We
see the formation of this alliance as a major endorsement of our business model
and a recognition of our successful track record in acquiring and developing
attractive new approaches to cancer therapy.

The alliance makes Roche the worldwide development and marketing partner for the
three products we currently have in clinical trials, and provides Roche with the
opportunity to opt in to all further oncology drugs starting trials over a
five-year period. Antisoma has received substantial upfront payments and will
benefit from milestone payments when products reach key stages in development,
as well as royalties on product sales.

Pipeline development

In July we announced that the independent Data Safety Monitoring Committee
(DSMC) for the pivotal phase III (SMART) trial of R1549 in ovarian cancer had
provided us with a revised estimate for the completion date of the trial, which
is now expected between December 2003 and February 2004. Roche is preparing for
the commercialisation of the drug, and together Antisoma and Roche are taking
the steps necessary to ensure that we are well placed to file for approval in
the US and Europe on receipt of a positive result. We expect to announce the key
findings of the trial during H1 2004, following analysis of the data.

SMART (Study of Monoclonal Antibody Radioimmuno-Therapy) is one of four ongoing
studies on R1549. We are also conducting two other ovarian cancer trials, MIDAS
and TOPDOC, which will provide important supplementary evidence on the
biodistribution, activity and tolerability of R1549. The fourth study is a pilot
phase II study in gastric cancer. Preliminary results were reported from the
gastric study during 2002 and final results are expected before the end of 2003.

There has been significant news on each of our other clinical products. In May
we initiated a new phase I study of our vascular targeting agent AS1404 (DMXAA)
in order to define appropriate doses for use in the phase II programme. In June
we began a new phase I study of R1550 (formerly Therex) in locally advanced or
metastatic (spreading) breast cancer, with initial recruitment taking place at
the UCLA's Jonsson Comprehensive Cancer Center in California. Roche plans to
conduct all future trials on R1550 in order to allow the broad potential of this
agent to be fully investigated. In August 2003 we announced that we had decided
not to pursue further development of AS1403 (formerly TheraFab), which was in
phase I development, following results from a biodistribution study. This
decision is in line with our policy of putting resources behind products with
the clearest commercial potential.

Our preclinical portfolio also continues to develop. We recently announced the
acquisition of rights to a programme based on inhibition of telomerase, an
enzyme crucial to the ability of cancer cells to divide unchecked by normal
controls. Our established targeted apoptosis programme is advancing well, and in
April the first animal data were presented on AS1406 (an antibody targeted
RNase, formerly TheraNase), which is the subject of a collaborative agreement
with the prestigious US National Institutes of Health. The data showed
encouraging anti-tumour effects in both breast cancer and lymphoma models.

Financial Highlights

The alliance with Roche has transformed Antisoma's financial position and
prospects. We ended the year with £34.0 million in cash and short-term
investments compared with £18.9 million last year. This reflects the substantial
upfront payments made by Roche on formation of the alliance: £4.15 million for
an approximately 9% post-deal shareholding in Antisoma and a further $37 million
(£23.2 million) for rights to our existing clinical pipeline and an option on
oncology products progressing to trials in the next five years.

We are accounting for the revenue from the Roche alliance in line with our
anticipated achievement of the development steps covered by the payments. We
therefore recognised £5.3 million from the upfront payments during the year, and
this contributed to an increase in total revenues to £11.8 million, from £2.2
million last year. Also important in this increase was £5.2 million received
from Roche in relation to development costs on R1549 and R1550, which are now
paid in full by Roche.

The increase in our revenues contributed to a reduction in our losses to £3.3
million for 2003, compared with £13.2 million for 2002. Losses per share were
1.5p, compared with 10.8p in 2002 and 9.3p in 2001. Net operating loss in the
second half of the financial year has fallen significantly to £0.3 million from
£5.1 million in the first half and £7.3 million in the corresponding period last
year. Ongoing losses reflect investment in our pipeline at levels exceeding
revenues, as expected for a biopharmaceutical company at our stage of
development. Our total operating costs rose from £15.7 million last year to
£17.2 million in 2003, as we continued to pursue a substantial programme of
clinical trials and other work pertinent to the advancement of our drugs.   
A breakdown of operating expenses is provided below:

     (£ million)                Year ended 30 June
                                2003          2002          2001

R1549 costs                      5.0           4.9           4.4
Other development costs          8.0           7.0           4.8
Administrative costs             4.2           3.8           3.4
Total                           17.2          15.7          12.6

The continuation of R1549 development costs during 2003 (£5.0 million) reflects
ongoing costs of recruiting and following up patients in the phase III ovarian
study (SMART), additional clinical studies (MIDAS and TOPDOC), and other costs
such as manufacturing associated with preparation for marketing. Other
development costs increased by £1.0 million to £8.0 million for the year ended
30 June 2003, due principally to manufacturing and other costs associated with
the start of new clinical trials on R1550 (formerly Therex) and AS1404 (DMXAA).
Administrative costs for the year increased to £4.2 million from £3.8 million
due to the costs associated with the completion of the deal with Roche.
Administrative costs also include a net charge for employer's National Insurance
contributions on share options of £5,000 (2002: £ nil).

Net cash inflow from operating activities in the year was £9.2 million. In
comparison, net cash outflows in the years to 30 June 2002 and 30 June 2001 were
£11.8 million and £7.0 million, respectively. The net outflow of cash from our
operating activities over the past three years has been due principally to our
operating losses.

Results of operations - quarter ended 30 June 2003

Revenues for the quarter ended 30 June 2003 were £4.7 million (Q4 2002: £0.7
million). Operating costs for the quarter ended 30 June 2003 were £4.9 million
(2002: £4.4 million) and included investment in research and development of £3.9
million (2002: £3.2 million). The cash outflow from operating activities for the
final quarter was £1.1 million compared to £7.1 million during Q3. Profits for
the quarter ended 30 June 2003 were £95,000 (Q4 2002: £3.5 million loss). For
the quarter ended 30 June 2003, the result per share was 0.0p (loss per share Q4

De-listing from NASDAQ Europe market

Our shares were voluntarily de-listed from NASDAQ Europe on 10 September 2003 in
anticipation of this market's closure in November 2003. Our shares will continue
to be traded on the London Stock Exchange.

Management changes

We have continued to strengthen our management team, with the appointment of Dr
Miroslav Ravic as Chief Clinical Officer demonstrating Antisoma's ability to
attract leading industry talent. Miroslav joined us from the Japanese
pharmaceutical group Eisai, where he was most recently Director of Clinical
Research and Development, Europe. He has brought invaluable clinical development
experience to Antisoma at an important stage of our growth.

We were also pleased to announce the promotion of Dr Nigel Courtenay-Luck, a
co-founder of Antisoma, to the position of Chief Scientific Officer. Nigel will
continue to oversee preclinical drug development at Antisoma but will also take
on a wider role, presenting the Company's science at key conferences and
building on Antisoma's relationships with academic and commercial institutions.
These are crucial to our continuing success at licensing in promising
early-stage drugs.

We have expanded our clinical and preclinical operations this year, taking on
additional staff, and are currently extending our laboratory facilities within
our St George's Hospital site in London.

Outlook for the next 12 months

We look forward to completing the phase III trial of R1549 by early next year.
Antisoma and Roche will take the preparatory steps necessary to ensure that we
are well placed to exploit a positive result. We also expect to receive further
results from our pilot phase II study of R1549 in gastric cancer. While R1549 is
clearly of great importance to the near-term future of the Company, we have
worked continually to build a broad-based pipeline. We now have a substantial
pipeline of products in development. In the coming year we intend to advance a
further product, AS1405 (formerly AngioMab), into clinical trials. We expect to
see the results from the ongoing trial of AS1404 and will continue, with Roche,
the development of the programme to maximise the potential of R1550. We will
also seek further opportunities to enhance our pipeline.

Barry Price                                             Glyn Edwards
Chairman                                                Chief Executive Officer

Consolidated profit and loss account
for the year ended 30 June 2003

                                                                          2003            2002            2001
                                                                     Unaudited         Audited         Audited
                                                                         £'000           £'000           £'000

Revenue                                                                 11,837           2,176           3,321
Operating expenses                                                    (17,212)        (15,738)        (12,621)
                                                                        ______          ______          ______

Operating loss                                                         (5,375)        (13,562)         (9,300)

Interest receivable                                                        978             382             666
Interest payable and similar charges                                         -            (11)            (23)
                                                                        ______          ______          ______
Loss on ordinary activities before
taxation                                                               (4,397)        (13,191)         (8,657)

Taxation on ordinary activites                                           1,098               -               -
Loss on ordinary activities after
taxation and retained loss for the year                                (3,299)        (13,191)         (8,657)
                                                                        ======          ======          ======
Loss per 1p share
Basic and diluted                                                         1.5p           10.8p           9.3p*
                                                                        ======          ======          ======

*Loss per share figures for 2001 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
as at 30 June 2003
                                                                          2003            2002            2001
                                                                     Unaudited         Audited         Audited
                                                                         £'000           £'000           £'000
Fixed assets
Tangible assets                                                            263             230             372
                                                                        ______          ______          ______
Current assets
Amounts falling due within one year                                      3,529             898           1,880
Amounts falling due after more than one year                                 -               -              13
                                                                        ______          ______          ______
                                                                          3529             898           1,893

Short-term deposits                                                     31,854          17,959           8,210
Cash at bank and in hand                                                 2,141             920             876
                                                                        ______          ______          ______
                                                                        37,524          19,777          10,979
amounts falling due within one year                                   (13,013)         (4,866)         (5,006)
                                                                        ______          ______          ______

Net current assets                                                      24,511          14,911           5,973
                                                                        ______          ______          ______

Total assets less current liabilities                                   24,774          15,141           6,345

amounts falling due after more than one year                           (8,715)               -               -
Provision for liabilities and charges                                     (70)                           (101)
                                                                        ______          ______          ______

Net assets                                                              15,989          15,141           6,244
                                                                        ======          ======          ======
Capital and reserves
Called up share capital                                                  6,613           6,405           5,208

Share premium account                                                   55,952          52,013          31,122

Other reserves                                                           4,300           4,300           4,300

Profit and loss account                                               (50,876)        (47,577)        (34,386)
                                                                        ______          ______          ______

Total shareholders' funds                                               15,989          15,141           6,244
                                                                        ======          ======          ======
Shareholders' funds analysed as:
Equity shareholders' funds                                              11,657          10,809           1,912
Non-equity shareholders' funds                                           4,332           4,332           4,332
                                                                        ______          ______          ______
                                                                        15,989          15,141           6,244
                                                                        ======          ======          ======

Consolidated cash flow statement
for the year ended 30 June 2003
                                                                          2003            2002            2001
                                                                     Unaudited         Audited         Audited
                                                                         £'000           £'000           £'000

Net cash inflow/(outflow) from operating activities                      9,185        (11,837)         (6,962)
                                                                        ______          ______          ______
Returns on investments and servicing of finance
Interest received                                                          897             363             565
Interest paid and similar charges                                            -            (11)            (23)
                                                                        ______          ______          ______
Net cash inflow from returns on
investments and servicing of finance                                       897             352             542
                                                                        ______          ______          ______

Net cash inflow from taxation                                            1,098               -               -
                                                                        ______          ______          ______

Capital expenditure and financial investment
Purchase of tangible fixed assets                                        (212)            (52)           (162)
Sale of tangible fixed assets                                                1               7               1
Purchase of intangible fixed assets                                          -           (397)            (44)
                                                                        ______          ______          ______
Net cash outflow for capital
expenditure and financial investment                                     (211)           (442)           (205)
                                                                        ______          ______          ______
Net cash inflow/(outflow) before
management of liquid resources and financing                            10,969        (11,927)         (6,625)
                                                                        ______          ______          ______
Management of liquid resources
Purchase of current asset investments                                 (13,895)         (9,749)         (3,960)
                                                                        ______          ______          ______
Issue of shares                                                          4,147          23,704          11,583
Expenses paid in connection with share issues                                -         (1,965)           (218)
Repayment of principal under finance leases                                  -            (19)            (77)
                                                                        ______          ______          ______
                                                                         4,147          21,720          11,288
                                                                        ______          ______          ______
Increase in cash                                                         1,221              44             703
                                                                        ======          ======          ======

Notes to the financial statements
for the year ended 30 June 2003

1.     Basis of reporting

The preliminary 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 16 September 2003 and are

As set out in the Joint Chief Executive and Chairman's Statement the Company
formed a strategic alliance with Roche resulting in upfront payments received of
$37 million and £4.15 million for an approximately 9% post-deal shareholding in
Antisoma. The Directors are confident that the Group has sufficient funds to
meet the requirements of the business for the foreseeable future. The financial
information in this preliminary statement is therefore prepared on a going
concern basis.

2.     Operating expenses

                                                             2003            2002            2001
                                                        Unaudited         Audited         Audited
                                                            £'000           £'000           £'000

Administrative expenses                                     4,179           3,837           3,408
Research and development costs                             13,033          11,901           9,213
                                                           ______          ______          ______

Net operating expenses                                     17,212          15,738          12,621
                                                           ======          ======          ======

3.     Reconciliation of operating loss to net cash flow from operating 

                                                             2003            2002            2001
                                                        Unaudited         Audited         Audited
                                                            £'000           £'000           £'000

Operating loss                                            (5,375)        (13,562)         (9,300)
Depreciation charge (net of disposals)                        179             189             210
Amortisation of intangibles                                     -             747              44
(Increase)/decrease in debtors                            (2,551)           1,012           (524)
Increase/(decrease) in creditors                           16,932           (223)           2,608
                                                           ______          ______          ______

Net cash inflow/(outflow) from operating                    9,185        (11,837)         (6,962)
                                                           ______          ______          ______

4.     Reconciliation of net cash flow to movement in net funds

                                                             2003            2002            2001
                                                        Unaudited         Audited         Audited
                                                            £'000           £'000           £'000

Increase in cash for the year                               1,221              44             703
Cash outflow from purchase of current asset
investments                                                13,895           9,749           3,960
Cash outflow from repayment of finance leases                   -              19              77
                                                           ______          ______          ______
Movement in net funds in the year                          15,116           9,812           4,740
Net funds at start of the year                             18,879           9,067           4,327
                                                           ______          ______          ______

Net funds at end of the year                               33,995          18,879           9,067
                                                           ______          ______          ______

The financial information set out in the announcement does not constitute the
Group's statutory accounts for the years ended 30 June 2003, 2002 or 2001 within
the meaning of section 240 of the Companies Act 1985. The financial information
for the years ended 30 June 2002 and 2001 is derived from the statutory accounts
for those years which have been delivered to the Registrar of Companies and
which are available on request from the Company Secretary, Antisoma plc, West
Africa House, Hanger Lane, London, W5 3QR. The auditors' report on those
accounts was unqualified and did not contain a statement under either section
237 (2) or 237 (3) of the Companies Act 1985. The statutory accounts for the
year ended 30 June 2003 will be finalised on the basis of the financial
information presented by the Directors in this preliminary announcement and will
be delivered to the Registrar of Companies following the Company's Annual
General Meeting.

                      This information is provided by RNS
            The company news service from the London Stock Exchange                                  

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