Final Results
Oxford Biomedica PLC
27 February 2002
27 February 2002
For further information, please contact:
Oxford BioMedica plc
Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000
City/Financial Enquiries:
Melanie Toyne Sewell / Fiona Noblet
Financial Dynamics Tel: +44 (0)20 7831 3113
Scientific/Trade Press Enquiries:
Chris Gardner, HCC•De Facto Group Tel: +44 (0)20 7496 3300
OXFORD BIOMEDICA PLC ('BIOMEDICA')
PRELIMINARY RESULTS FOR
THE YEAR ENDED 31 DECEMBER 2001
• Funding: Successful move from AIM to the main market of the London
Stock Exchange in April 2001, with a placing and open offer raising £32.3
million, net of expenses; proceeds being invested to expand clinical and
development pipelines, and establish a US subsidiary.
• Financial performance: Turnover for the year ended 31 December 2001
was £0.4 million (2000: £0.7 million), loss after tax was £8.4 million (2000:
£5.0 million), in line with expectations.
• Research & development: Substantial investment in development
programmes, with two products in the clinic and seven in preclinical
development.
• Cash position: Bank balance at 31 December 2001 was £32.6 million
(2000: £11.6 million); capital expenditure increased to £3.2 million in 2001
(2000: £0.9 million) due to investment programmes and expansion, but is expected
to decrease in 2002.
• Clinical: Positive interim data on MetXia(R) and TroVax(R), presented
at the Beeson Gregory cancer conference in February 2002.
• MetXia(R): Two out of four patients completing the MetXia(R) trial
showed reductions in the sizes of tumours that had been injected with MetXia(R).
One of these showed a marked improvement of a cancerous lesion that had not been
treated directly, suggesting that MetXia(R) not only induces tumour death in
directly treated tumours but may also induce an immune response that destroys
other tumours in the patient's body. If these observations are sustained in the
subsequent BC2 trial the market potential for MetXia(R) will be broader than
originally anticipated as the product could be used for the treatment of both
primary and secondary tumours.
• TroVax(R): Two out of the three immunocompetent patients in the low
dose group of the TroVax(R) trial showed clinical improvements. In one patient
the TroVax(R)-induced immune response was associated with a period of disease
stabilisation and in another it correlated directly with substantial tumour
death. Data for the mid-dose and high-dose groups are being accumulated at
present and initial results will be released within the next few months. On the
basis of these positive results the Group is considering Phase II studies both
in the UK and the USA.
• Preclinical development: Acceleration of the neurobiology preclinical
programme; ProSavin(R), the Parkinson's product, has shown efficacy in
preclinical models and is on course to move into clinical development during
2002 with initial discussions with the FDA taking place within the next few
months.
• Research: First milestone achieved with nerve regeneration programme
with King's College, London. Subject to preclinical data and production
development, ProCaStat(R), for prostate cancer, is set to proceed through
preclinical research and enter clinical development during 2002. ProCaStat(R)
may be BioMedica's first LentiVector(R) product to enter clinical trials.
• Gene Discovery: First drug targets identified; discussions ongoing
with chemistry companies to develop lead compounds for stroke and cardiovascular
disease.
• External programmes: Extension of programmes with Wyeth and IDM;
continuation of collaborations with Aventis, Valentis and Nycomed Amersham;
termination of diabetes project with Modex in October via mutual agreement.
• Patents: 33 patents were awarded to BioMedica during 2001 including
broad patents covering the Group's LentiVector(R) technology; 20 new
applications were filed; to date every patent application that has proceeded to
examination has been granted.
• Board appointments: Raj Uppal as a non-executive director and Dr Doug
Jolly as Chief Executive Officer of the US subsidiary, BioMedica Inc. and to the
Group Board.
Commenting on the Preliminary Results, Dr Peter Johnson, Chairman of Oxford
BioMedica, said:
'2001 has been a landmark year for BioMedica with its move to the Official List,
the establishment of a US operation and early, positive clinical results
emerging from our internal development programmes. With the funds raised, we
have invested significantly in the Group; we expect to see results from this
investment coming through in 2002 with a substantial expansion of the clinical
programmes arising from our oncology and neurobiology activities as well as a
number of new product opportunities.'
-Ends-
Notes to Editors
1. Oxford BioMedica plc
Established in 1995, the Company specialises in the application of gene-based
technology to the development of novel therapeutics. Its three principal
activities are in the fields of gene therapy, immunotherapy and genomics, and
its principal therapeutic areas are in cancer and neurodegenerative diseases.
Oxford BioMedica plc was floated on the Alternative Investment Market of the
London Stock Exchange in December 1996, and was promoted to the United Kingdom
Listing Authority Official List in April 2001 following a successful £35.5
million fund-raising.
Oxford BioMedica is headquartered in Oxford, UK and has operating centres in
Oxford and San Diego, USA.
Currently Oxford BioMedica has corporate collaborations with Aventis, IDM,
Nycomed Amersham, Valentis, Virbac and Wyeth. BioMedica has two products in
Phase I/II clinical trials: MetXia(R) for late-stage breast cancer, and TroVax
(R) for late-stage colorectal cancer.
2. World Wide Web
This release is also available on the World Wide Web at: http://
www.oxfordbiomedica.co.uk
Chairman and Chief Executive's Report
In gaining admission to the Official List of the United Kingdom Listing
Authority and to trading by the London Stock Exchange in April 2001, Oxford
BioMedica achieved a major goal. The Company also raised £35.5 million before
expenses in a placing and open offer that was supported by major institutions in
London and Europe - a substantial accomplishment in difficult financial markets.
This success was a direct result of the Group's technical, clinical and
commercial progress since its foundation in 1996.
The fundraising and move to the Official List resulted in many existing
shareholders reinvesting, and it also brought more than 15 new institutions onto
the shareholder register. As a result, the breadth of BioMedica's institutional
investor base has expanded. The money raised has enabled the Group to expand
its clinical programmes, to continue its aggressive research and development
programme, to increase its facilities in Oxford and to establish a wholly owned
subsidiary, BioMedica Inc. in San Diego, California. BioMedica Inc. will
develop new production technologies for the Group's products, run much of the
neurobiology research and development, and act as a focal point for interactions
with the FDA as BioMedica moves towards conducting clinical trials in the USA.
The subsidiary will also function as an important centre for business
development in the USA and, in that role, new opportunities are already being
created.
Clinical Development
Beyond the move to the Official List, some of BioMedica's most important recent
events have been in the clinical development programmes.
In July 2001, the Gene Therapy Advisory Committee gave BioMedica approval for a
'new' version of MetXia(R) to be used in the Phase I/II MetXia(R) clinical
trial. The rapidity of approval was testament to the quality of the safety and
gene transfer data obtained in the first part of the MetXia(R) BC1 trial.
At the Beeson Gregory Cancer conference in February 2002, BioMedica presented
encouraging results from the first part of the BC1 trial. In Phase I/II cancer
trials it is common for patients to drop out of the trial because of the
severity of their disease. However, of the four patients who did complete the
trial, two showed clear reduction in the size of their treated tumours. In
addition, one of the patients showed a clear improvement in a cancerous skin
lesion that had not been treated directly. This suggests the involvement of a
systemic anti-tumour immune response that might be exploited to clear secondary
tumours and thereby broaden the market for MetXia(R).
BioMedica also presented interim results from the TroVax(R) trial, where there
was also evidence of clinical improvement. Tumour destruction was correlated
with an immune response induced by TroVax(R) in two out of three immunocompetent
patients. These interim data are exciting and provide a useful basis for future
trials. However, because of the small size of the trial group and the varying
stages of disease amongst the patients, further analysis will be required before
firm conclusions can be made about the efficacy of MetXia(R) and TroVax(R).
Together with the safety, gene transfer and immunological data, these initial
results support the continuing investment in MetXia(R) and TroVax(R). This
includes the alternative formulations of MetXia(R) and TroVax(R), MetXia(R)-MG
and MetXia(R)-VM and TroVax(R)-DC. The development pipeline is strong with
several new clinical programmes due to start this year (see Figure 1).
Product Portfolio (Figure 1)
Product Resource Research Preclinical Phase I/II
MetXia(R) (Cancer) BioMedica Phase I/II
MetXia(R)-MG (Cancer) BioMedica/IDM Preclinical
MetXia(R)-VM (Cancer) BioMedica/Valentis Preclinical
TroVax(R) (Cancer) BioMedica Phase I/II
TroVax(R)-DC (Cancer) BioMedica/IDM Preclinical
TroVax(R)-Vet (Vet cancer) Virbac Research
OBA1 Immunotoxin (Cancer) AHP/Wyeth Research
OBA1 Imaging (Cancer) Amersham Research
BetOvac(R) (Ovarian cancer) BioMedica Preclinical
ProCaStat(R) (Prostate cancer) BioMedica Preclinical
ProSavin(R) (Parkinson's) BioMedica Preclinical
RenurexTM (Nerve repair) BioMedica Research
Neovascularisation (Cardio) Aventis Research
ImmStat(R) (HIV infection) BioMedica (on hold) Preclinical
Preclinical Research
Progress has been made on all fronts, but the preclinical highlight of the year
has been in neurobiology. At the time of the April 2001 fundraising, BioMedica
stated that some of the money raised would be used to accelerate development of
the Group's neurobiology products. In the Parkinson's disease programme,
ProSavin(R) was shown to correct the symptoms in a preclinical model of the
disease, putting the candidate product on course for clinical development in
2002.
In addition, BetOvac(R) has shown good efficacy in preclinical models of ovarian
cancer, and the hypoxia response element that brings genes under the control of
oxygen concentration was used in the successful development of a candidate for
treating anaemia.
Research
The Group's research ranges from small exploratory activities to major projects
aimed at establishing novel product development programmes. In the nerve
regeneration programme with King's College, London, the first major milestone in
the collaboration was achieved. Progress to date with this collaboration has
been rapid, and this bodes well for the future of this innovative approach to
nerve repair for spinal injury and diabetic neuropathy. The programme has now
entered the preclinical phase.
Other important developments were the demonstration that the hypoxia response
element can be used to control the treatment of retinopathies, the most common
cause of blindness, and the configuration of a lentiviral vector-based candidate
product for prostate cancer, ProCaStat(R). Subject to obtaining preclinical
efficacy data and the development of a clinically useful vector production
process, ProCaStat(R) is a candidate for the first LentiVector(R) product that
the Group will take to the clinic.
Gene Discovery Division
BioMedica's genomics activity is now fully staffed and housed in new facilities
on the Oxford Science Park alongside the laboratories that are used for
therapeutic product development. The initial programme has already generated
potential targets for stroke, angiogenesis and inflammation. New programmes in
neurobiology are gaining pace with further work being done in stroke and nerve
regeneration. Coincident with BioMedica's move into focused genomics has been a
general change in the market, with a greater emphasis on downstream products.
The directors believe that BioMedica is well placed to respond to this change,
and the Group has already taken steps to move its focus from target
identification to product lead generation, both for new biological and new
chemical entities. BioMedica is in discussion with small molecule development
companies to generate candidate drugs for novel targets in order to leverage the
value of its discovery programme.
External Programmes
The major commercial event of the year was the deal with Wyeth-Ayerst
Laboratories, the pharmaceutical division of American Home Products Corporation
('Wyeth') for the development and commercialisation of a novel anti-cancer
therapy based on an Oxford BioMedica proprietary antibody. This collaboration is
progressing well, with the second payment having been received in February 2002
from Wyeth for the continuation of the programme. This programme has also laid
the foundations for building a future capability in antibody technology.
In the collaboration with IDM S.A., the goal of defining new clinical programmes
during 2001 was achieved, and this should result in new clinical trials starting
in 2003.
The Aventis cardiovascular programme has been delayed by the transfer of the
Aventis gene therapy activities to Gencell. However, the interaction remains in
place.
All of the Group's other collaborations are progressing, with the exception of
the diabetes project with Modex, which was terminated by mutual agreement in
October 2001, due to Modex changing its business plan. BioMedica's LentiVector
(R) technology worked well and was able to deliver genes to the
insulin-producing b-islet cells at high efficiencies. As a result, the Group
anticipates that the Modex programme will be replaced by another diabetes
collaboration in due course.
Intellectual Property
More than a quarter of BioMedica's patent portfolio has now been examined in the
major territories of Europe, USA and Japan. So far, every application that has
proceeded to examination has led to an issued patent. 2001 was a particularly
good year with 33 patents being granted including broad patents for LentiVector
(R) and other aspects of gene delivery and regulation. In addition, 20 new
applications were filed during 2001, protecting the growing output from the Gene
Discovery Division and enhancing the protection of the product development
programmes in immunotherapy and neurobiology. The Group will continue to pursue
an aggressive patent strategy to build a portfolio that constitutes the
foundations of shareholder value.
Commercial Strategy
The overall strategy continues to be the management of risk, inherent in
pharmaceutical product development, by creating as many commercial opportunities
as possible. Any one of the product opportunities that the Group has created so
far could make BioMedica profitable if it reached the market. However, this
must be achieved within a controlled budget. This approach has been successful
so far, with the Group funding internal product development in cancer and
neurobiology, and partners funding and carrying out the majority of the other
collaborative programmes. This dual approach will continue, but as the Group's
clinical trials progress, there will be a greater emphasis on establishing
partnerships for internal product programmes. This will begin in 2002.
However, there is always a balance to be struck between an early deal and
investing further in the product to increase its value. The intriguing but
anecdotal clinical benefits to patients in the MetXia(R) and TroVax(R) trials
make this judgement of fundamental importance for mid-term shareholder value.
The events of September 11th and the economic downturn of last year led many
companies to retrench. This slowed progress on several potential new
collaborations. Nevertheless, there remains considerable interest in the
Group's technology and candidate products from both biotech and pharmaceutical
companies.
Financial
The placing and open offer has significantly strengthened the balance sheet, and
has allowed the planned increase in operations, including the programmes
described above. The average headcount increased in 2001 by 49% from 49 to 73,
and the Oxford offices and laboratories were expanded from 11,000 sq.ft. to
28,000 sq.ft. BioMedica Inc. was incorporated in February 2001 and began
operations in the second half of 2001.
The 2001 financial result was in line with the budget that was set at the time
of the placing and open offer. Operating expenses in 2001 were £11.4 million, an
increase of 69% over 2000 as a result of increased levels of activity. This was
offset by higher interest receivable on bank deposits and a three-fold increase
in the UK Corporation Tax research and development credit. The loss after tax
for 2001 was £8.4 million (2000 loss: £5.0 million).
Capital expenditure in 2001 was £3.2 million, of which £2.4 million was for the
fitting out and equipping of new laboratories and offices in Oxford, and £0.5
million was for equipment at BioMedica Inc. The bank balance at 31 December 2001
of £32.6 million (2000: £11.6 million) was in line with the budget. The net cash
outflow was £11.9 million (2000: £5.6 million).
Changes to the Board
During the year BioMedica made two key appointments. In February 2001 the Group
welcomed Mr Raj Uppal to the board as a non-executive director. Raj is a
Chartered Accountant and has extensive financial and commercial experience in
the sector. He is currently a Senior Vice President of the drug delivery
business unit of Elan Corporation. In May 2001 Dr Doug Jolly was appointed CEO
of the Group's US subsidiary BioMedica Inc., and to the Group board. Dr Jolly is
a leading figure in gene technology in the USA. He is a named inventor on many
patents, and was founder and Vice-President of Research of Viagene Inc. Most
recently he held the position of Vice President for Scientific Affairs at Chiron
Corporation's Center for Gene Therapy.
In Summary
2001 has been a landmark year for BioMedica with its move to the Official List,
the establishment of a US operation and the greater emphasis on clinical results
emerging from its internal programmes. As a result of the funds raised in 2001,
the Group has been able to make substantial increases in the level of investment
in research and development and in facilities and equipment, in order to expand
its development and clinical pipelines and so to build up the base from which
future shareholder value will be derived. Looking forward, the focus for 2002 is
to extend the clinical and preclinical pipeline further. In particular, we
expect to complete the Phase I/II trials for MetXia(R) and initiate Phase II
clinical trial programmes with TroVax(R). We thank our shareholders and our
dedicated, hard-working staff for their significant support during 2001 and we
look forward to further success during 2002.
Dr Peter Johnson Chairman
Prof. Alan Kingsman Chief Executive Officer
Consolidated profit and loss account
for the year ended 31 December 2001
2001 2000
Notes £'000 £'000
Turnover 2 373 732
Research and development costs (8,570) (5,033)
Administrative expenses (2,859) (1,731)
Operating expenses (11,429) (6,764)
Other operating income: government grants receivable 29 96
Net operating expenses (11,400) (6,668)
Operating loss (11,027) (5,936)
Interest receivable 1,486 541
Loss on ordinary activities before taxation 2 (9,541) (5,395)
Tax credit on loss on ordinary activities 3 1,152 393
Loss for the year (8,389) (5,002)
Basic loss and diluted loss per ordinary share 4 (3.8p) (3.1p)
The results for the years above are derived entirely from continuing operations.
There is no difference between the loss on ordinary activities before taxation
and the loss for the years stated above, and their historical cost equivalents.
Statement of group total recognised gains and losses
2001 2000
Notes £'000 £'000
Loss for the financial year (8,389) (5,002)
Currency translation differences on foreign currency net 8 (2) -
investments
Total recognised losses for the year (8,391) (5,002)
Consolidated balance sheet
at 31 December 2001
2001 2000
Notes £'000 £'000
Fixed assets
Intangible assets 234 283
Tangible assets 5 3,647 1,304
Investments 26 26
3,907 1,613
Current assets
Debtors 6 2,712 1,069
Cash at bank and in hand 32,645 11,635
35,357 12,704
Creditors: amounts falling due within one year 7 (1,756) (1,340)
Net current assets 33,601 11,364
Net assets 37,508 12,977
Capital and reserves
Called-up share capital 2,382 1,721
Share premium account 58,689 26,428
Other reserve 711 711
Profit and loss account (deficit) (24,274) (15,883)
Equity shareholders' funds 8 37,508 12,977
Consolidated cash flow statement
for the year ended 31 December 2001
2001 2000
£'000 £'000
Operating activities
Net cash outflow from continuing operating activities
(reconciliation to operating loss below) (9,846) (5,306)
Returns on investments and servicing of finance
Interest received 1,120 407
Taxation
Overseas tax paid (2) -
Capital expenditure
Purchase of tangible fixed assets (3,182) (683)
Net cash outflow before management of liquid resources and financing (11,910) (5,582)
Management of liquid resources
Transfer to deposit accounts (32,190) (14,729)
Transfer to current accounts 10,886 3,637
(21,304) (11,092)
Financing
Issue of ordinary shares 36,108 14,603
Expenses of share issue (3,186) (425)
Net cash inflow from financing 32,922 14,178
Decrease in cash in the year (292) (2,496)
Reconciliation of operating loss
to net cash outflow from operating activities
2001 2000
£'000 £'000
Continuing activities
Operating loss (11,027) (5,936)
Amortisation of intangible fixed assets 49 49
Depreciation of tangible fixed assets 840 321
Loss on disposal of fixed assets 1 5
Decrease in debtors due after more than one year 37 -
Increase in trade debtors - 24
Decrease/(increase) in other debtors and other tax receivable 16 (52)
Increase in prepayments and accrued income (163) (82)
Increase in trade creditors 216 99
Increase in other taxation and social security 58 57
Increase in accruals and deferred income 127 209
Net cash outflow from continuing operating activities (9,846) (5,306)
Notes to accounts
1 Basis of preparation
The preliminary results for the year ended 31 December 2001 do not constitute
the Company's statutory financial statements within the meaning of s227 of the
Companies Act 1985, but are derived from the audited statutory financial
statements. The financial information for the year ended 31 December 2000 is
derived from the statutory accounts for that year which have been delivered to
the Registrar of Companies. The auditor's reports on these accounts were
unqualified.
The new accounting standard FRS 18 (Accounting policies) has been adopted in the
current year. This has not resulted in any changes in accounting policies.
Copies of this announcement are available from the Company Secretary. The
audited statutory financial statements for the year ended 31 December 2001 are
expected to be distributed to shareholders by 15 March 2002 and will be
available at the registered office of the Company, Medawar Centre, Oxford
Science Park, Oxford, OX4 4GA.
This announcement was approved by the Board of Oxford BioMedica plc on 26
February 2002.
2 Turnover and loss on ordinary activities before taxation
The Group's turnover and loss on ordinary activities before taxation are derived
entirely from its principal activity. With the commencement of operations of
BioMedica Inc., the Group now has operations in the United Kingdom and in the
United States of America.
2001 2000
Turnover Turnover by Turnover by Turnover by Turnover by
destination origin destination origin
Geographical analysis £'000 £'000 £'000 £'000
United Kingdom 67 373 283 732
Rest of Europe 35 - 85 -
North America 271 - 364 -
373 373 732 732
Loss on ordinary activities before taxation 2001 2000
Geographical analysis £'000 £'000
United Kingdom 8,770 5,395
North America 771 -
9,541 5,395
Net assets 2001 2000
Geographical analysis £'000 £'000
United Kingdom 4,352 1,342
North America 511 -
Net operating assets 4,863 1,342
Cash at bank and in hand 32,645 11,635
37,508 12,977
3 Tax credit on loss on ordinary activities
The Group is entitled to claim tax credits for certain research and development
expenditure. The amount included in the financial statements for the year ended
31 December 2001 represents the credit receivable by the Group for that year,
less income tax payable by the Group's subsidiary in the United States of
America. These amounts have not yet been agreed with the relevant tax
authorities.
2001 2000
£'000 £'000
United Kingdom Corporation Tax research and development credit 1,167 393
Overseas taxation (15) -
1,152 393
4 Basic loss and diluted loss per ordinary share
The basic loss per share has been calculated by dividing the loss for the year
by the weighted average number of shares of 219,196,867 in issue during the year
ended 31 December 2001 (2000: 161,851,789).
The Company had no dilutive potential ordinary shares in either year which would
serve to increase the loss per ordinary share. There is therefore no difference
between the loss per ordinary share and the diluted loss per ordinary share.
5 Tangible fixed assets
Short Leasehold Office
improvements equipment, Computer Laboratory
fixtures and equipment equipment Total
fittings
£'000 £'000 £'000 £'000 £'000
Cost
At 1 January 2001 460 109 708 1,051 2,328
Additions 1,414 103 259 1,408 3,184
Disposals - (1) (46) - (47)
At 31 December 2001 1,874 211 921 2,459 5,465
Depreciation
At 1 January 2001 330 69 75 550 1,024
Charge for the year 211 29 258 342 840
Eliminated on disposals - (1) (45) - (46)
At 31 December 2001 541 97 288 892 1,818
Net book amount at 31 December 2001 1,333 114 633 1,567 3,647
Net book amount at 31 December 2000 130 40 633 501 1,304
6 Debtors
2001 2000
£'000 £'000
Amounts falling due after more than one year
Other debtors - rent deposit - 37
Amounts falling due within one year
Other debtors 531 279
Corporation tax receivable 1,560 393
Other tax receivable 193 95
Prepayments and accrued income 428 265
2,712 1,032
Total debtors 2,712 1,069
7 Creditors: amounts falling due within one year
2001 2000
£'000 £'000
Trade creditors 638 430
Overseas taxation 13 -
Other taxation and social security 181 123
Accruals and deferred income 924 787
1,756 1,340
8 Reconciliation of movements in Group shareholders' funds
2001 2000
£'000 £'000
Loss for the year (8,389) (5,002)
New share capital issued 36,108 14,603
Expenses of share issue (3,186) (425)
Exchange differences (2)
Net addition to shareholders' funds 24,531 9,176
Opening shareholders' funds 12,977 3,801
Closing shareholders' funds 37,508 12,977
This information is provided by RNS
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