OXFORD BIOMEDICA
Oxford Biomedica Preliminary Results for the
Year Ended 31 December 2000
- Financial
performance: turnover for the year ended 31 December 2000
was £0.7 million (1999: £0.4 million), with revenue from 3 new
commercial alliances. Loss after tax was £5.0 million (1999: £4.2
million).
- Research
& development:
R&D expenditure was £5.0 million (1999: £3.8 million), which included
the establishment of the Gene Discovery Division.
- Cash
position: the bank balance at 31 December 2000 was £11.6 million
(1999: £3.0 million). £14.2 million was raised, net of costs,
by issues of shares, including the placing of 13.7 million shares
in January 2000 and 14.6 million shares in August 2000.
- Clinical
progress: positive Phase I results from MetXia® with good
safety and gene transfer data in BC1 (breast cancer) trial. MetXia®
is also in a Phase I/II ovarian cancer trial. In January 2001
the cancer vaccine, TroVaxT entered Phase I/II clinical trials
in colorectal cancer.
- Commercial
activity:
there are now 10 commercial alliances with pharmaceutical and
biotech companies including AstraZeneca, Aventis, Nycomed Amersham
and, signed in January 2001, a collaboration with Wyeth-Ayerst
potentially worth $24 million.
- Gene
discovery: This
new division was established in August 2000 and has already identified
new genes believed to be mechanistically linked with diseases
such as cancer, cardiovascular disease and inflammation. Significant
progress is expected from this division in the next financial
year.
- New appointments:
Dr Paul Durrands joined the Board as Commercial Director. Dr Peter
Johnson replaced Alan Goodman as non-executive Chairman.
Commenting on
the Preliminary Results, Dr Peter Johnson, Chairman of Oxford BioMedica
said:
"This has been another year of substantial achievements for the
Company, with the reporting of the first clinical results for MetXia®,
approval of the clinical trials of our second product, TroVaxT,
and the expansion of our work in the genomics field through the
Gene Discovery Division.
We continue
to focus on building shareholder value by creating as many routes
as possible for our unique technology to enter substantial pharmaceutical
markets. We are pleased with the position we have reached so far,
with ten commercial collaborations, three clinical trials in progress
and a pipeline of new opportunities, coupled with a stronger balance
sheet as a result of the successful fund-raisings in 2000. We look
forward to further growth in 2001."
Notes to
Editors
- Oxford
BioMedica plc
Established in 1995, the Company specialises in the development
and application of gene-based therapeutics and immunotherapeutics
for the treatment of disease in the areas of Oncology, Neurobiology
and Viral Infection. During 2000 Oxford BioMedica expanded its
activities by the establishment of a Gene Discovery Division which
applies the Company's gene-based technologies in the field of
genomics with the intention of identifying genes that may be linked
to disease. Oxford BioMedica plc was floated on the Alternative
Investment Market of the London Stock Exchange in December 1996.
Currently
Oxford BioMedica has corporate collaborations with Aventis, AstraZeneca,
IDM, Modex Therapeutics, Nycomed Amersham, Valentis, Virbac and
Wyeth-Ayerst. BioMedica has two products in Phase I/II clinical
trials. MetXia® is in clinical trials for late-stage breast cancer
(BC1) and ovarian cancer (OC1), and TroVaxT is in clinical trials
for late-stage colorectal cancer.
CHAIRMAN'S
STATEMENT
Oxford BioMedica
has made substantial progress in 2000. In November the Company reported
the successful completion of the first stage of the Phase I/II clinical
trial of MetXia® in cancer patients with surface skin nodule tumours.
In December BioMedica's second product, TroVaxT, received approval
for a Phase I/II trial in colorectal cancer patients. This clinical
trial commenced in January 2001. In addition, the Company's preclinical
programmes have moved ahead well, particularly in the neurobiology
field.
The formation
of the Gene Discovery Division further broadened the Company's commercial
base adding another route to value as the pharmaceutical and biotechnology
industries enter the post-genome era. BioMedica now has ten corporate
alliances in place including deals with Aventis, Nycomed Amersham
and AstraZeneca and, signed in January 2001, a collaboration with
Wyeth-Ayerst to develop antibody-based products with a potential
value from access, option and milestone payments of $24 million.
FINANCIAL
REVIEW
In 2000 Oxford
BioMedica continued to manage its finances prudently, and was able
to take advantage of two opportunities to raise new funds in institutional
share placings.
Income was
£732,000 in 2000 (1999: £436,000). The increased revenue arose from
expansion of existing collaborations with Aventis and Modex, and
new collaborations with AstraZeneca, Nycomed Amersham and Virbac.
The loss for the year after tax was £5.0 million (1999: £4.2 million).
Operating expenses
were £6.8 million (1999: £5.1 million). Of this, research and development
costs were £5.0 million (1999: £3.8 million). The increased research
and development costs reflect the continuing expansion of research,
preclinical and clinical programmes, and the establishment in August
2000 of the Gene Discovery Division. In addition it includes a substantial
and growing investment in creating and maintaining the Company's
intellectual property portfolio. Administrative expenses were £1.7
million (1999: £1.3 million). Grant income was £0.1 million (1999:
£0.3 million) as the Company completed its three current grant programmes.
Capital expenditure
in 2000 was £0.9 million (1999: £0.1 million); £0.6 million of this
was used for advanced computer hardware and software to support
the implementation of bioinformatics by the Gene Discovery Division.
From April 2000
the Company is entitled to claim tax credits for certain research
and development expenditure, and consequently the 2000 accounts
include a tax credit of £0.4 million (1999: nil). Tax losses on
other expenditure will be available for offset against future taxable
profits.
Financing
A total of £14.2 million was raised by the issue of shares in 2000,
detailed in the table below. With the authority given to the Directors
by the Company's shareholders, the Company was able to complete
two institutional cash placings, free of statutory pre-emption rights,
to raise new funds quickly and cost-effectively.
| Date |
Reason
for issue |
Shares
issued |
Price
per share |
Net
proceeds |
| January
2000 |
Institutional
placing |
13.7 million |
38p |
£5.0 million |
| May 2000 |
Subscription
by 3 US institutions |
0.5 million |
55p |
£0.3 million |
| August
2000 |
Institutional
placing |
14.6 million
|
60p |
£8.5 million |
| August
2000 |
Employee
options |
1.1 million |
33p |
£0.4 million |
| Total
amount raised |
£14.2
million |
As a result
of increased operating expenses and higher capital expenditure,
the net outflow of funds before new share issues was £5.6 million
in 2000 (1999: £3.7 million). The bank balance at 31 December 2000
was £11.6 million.
The funds raised
in 2000 have allowed BioMedica to increase its investment in research
and development, and in particular to establish the Gene Discovery
Division. As a result the Directors believe that the potential for
future returns from the Company's technology has been enhanced.
Since it is the Company's commercial strategy to proceed with the
clinical development of candidate products up to and including Phase
I/II clinical trials, the Company will require further funds in
due course.
OPERATIONAL
REVIEW
During the
year the Company made good progress in its three main activities:
Gene Therapy, Gene-based Immunotherapy and Gene Discovery, and has
progressed well with its external collaborations.
Clinical
Development of BioMedica's Products
Oxford BioMedica made significant advances in its clinical programmes
in 2000. In November, the Company reported that MetXia® had met
all of the goals in the first part of the Phase I/II BC1 trial in
cancer patients with surface skin nodule tumours, mainly arising
from breast cancer. In addition the Company was granted approval
to use MetXia® in a Phase I/II trial (OC1) in ovarian cancer patients,
and that trial has started.
The successful
completion of the first part of the BC1 trial has prompted the Company
to build a product family around MetXia® thereby broadening its
commercial potential. In
December 2000, BioMedica established a collaboration with the major
US gene therapy company Valentis to develop a version of MetXia®
for systemic administration using Valentis' PEGylation technology.
In December
2000 the Company's second lead candidate product, TroVaxT, received
approval from the Medicines Control Agency for a Phase I/II trial
(TV1) in colorectal cancer patients. The TV1 trial is being conducted
at the Christie Hospital, Manchester. Not only is this an important
step in terms of the development of TroVaxT as a product, but it
is also a major component of the Company's qualification for admission
to the United Kingdom Listing Authority's Official List.
Preclinical
Research and Development
During the year there were a number of major technical developments
and the Company made significant progress in taking its products
towards the clinic. Two areas are worthy of special note: neurobiology
and immunotherapy.
The neurobiology
programme gained pace with substantial achievements from both the
LentiVector® team, in terms of efficiency of gene transfer to neurones,
and the neurobiology team, in terms of the development of BioMedica's
Parkinson's disease product, ProSavin®. The Directors believe that
BioMedica has world leading technology for delivering genes to the
cells of the central nervous system, and that this will create a
range of commercial opportunities in the future.
In addition,
the demonstration by the Company's immunotherapy group that an antibody
against the proprietary tumour antigen OBA-1 has direct anti-tumour
effects in model systems has opened the way for BioMedica to enter
the antibody therapy field. The signing of a collaborative agreement
with a potential value from access, option and milestone payments
of US$ 24 million in January 2001 with Wyeth-Ayerst Laboratories
(a division of American Home Products Corporation) is one example
of the validation of BioMedica's antibody technology, and further
developments are expected in this area during the coming year.
Gene Discovery
Division
2000 was an historic year for biomedical science with the completion
of the sequencing of the human genome. Oxford BioMedica, as a leader
in gene-based technology, is ideally placed to realise the potential
of the post-genome era, particularly through the activities of the
Gene Discovery Division.
The establishment
of the Gene Discovery Division in the second half of the year addresses
the problem of identifying those genes, amongst the 100,000 genes
in the genome, that are mechanistically involved in disease processes
and are therefore prime candidates as targets for product development.
The Company raised £8.5 million by a share placing in August 2000
to accelerate the development of business opportunities in this
field.
The Gene Discovery
Division has already achieved commercial success through target
validation deals with AstraZeneca and Aventis, and further deals
are in discussion with both pharmaceutical companies and genomics
companies. In addition, patents have been filed covering the first
genes identified using BioMedica's proprietary SmartomicsT technology.
These genes may have applications in cancer, cardiovascular disease
and inflammation. In the coming year, the Company expects to make
significant further progress with the Gene Discovery Division as
new collaborations are agreed and as more genes are identified,
particularly in the field of neurological disorders.
External
Collaborations
The Company's collaborative alliances are progressing well. In June
2000 BioMedica announced the expansion of the collaboration with
Aventis in cardiovascular disease. In addition six new collaborations
have been signed:
- January
2000 IDM S.A. in the field of cell-based therapies;
- February
2000 AstraZeneca in the field of genomics;
- February
2000 Virbac S.A. for the development of a veterinary version of
TroVaxT;
- March 2000
Nycomed Amersham for tumour imaging;
- December
2000 Valentis Inc. for the development of MetXia®; and
- January
2001 AHP/Wyeth in the field of anti-cancer antibody therapy.
Intellectual
Property
BioMedica's intellectual property portfolio represents the foundations
of the Company's value. New patents were filed in 2000, seven patents
were granted and notices of allowance were received for a further
five patents. Of particular importance has been the Company's increasing
portfolio of successful patent applications in the field of LentiVector®
technology.
Commercial
Strategy
The BioMedica management team recognises that the commercial development
of novel therapeutics is a process that offers substantial reward,
but that has a number of associated risks. These risks are a function
of the gap in knowledge that exists between the data generated in
preclinical studies and the ability to predict efficacy of a product
in human clinical trials. It is the responsibility of any biotech
management to manage that risk effectively and BioMedica faces this
challenge head-on through its technical and commercial strategies.
The overriding
principle followed by the Company is to develop as many credible
routes to major pharmaceutical markets as possible while containing
costs within strict budget constraints. BioMedica is developing
in-house technologies and a range of candidate products, designed
to address unmet medical needs where there is substantial market
potential, in the areas of cancer, neurodegenerative disease and
AIDS.
Also, the Company
creates market opportunities by joining with others and applying
its technology and product components to collaborative product development
projects, often outside the fields of the internal programmes. As
part of these alliances, the partner often pays for all or a significant
part of the research and development programme, and therefore the
early risk to BioMedica is reduced.
In addition
the Company further leverages its proprietary technology by supplying,
through the Gene Discovery Division, leading edge capabilities to
the pharmaceutical industry for developing new products that arise
out of genomics and proteomics.
The continued
pursuit of this strategy means that BioMedica's value does not reside
in any single product, product component or technology. Instead,
the Company's value is distributed across several short-term and
long-term revenue opportunities any one of which has the potential
to yield substantial returns. The directors believe, therefore,
that the overall prospects for BioMedica are good.
Appointments
In June 2000 Dr Paul Durrands joined the Board as commercial director.
He has specific responsibility for the commercial development of
the Gene Discovery Division. On 1 January 2001 Alan Goodman retired
from the board of BioMedica. Mr Goodman had served as a non-executive
director for over four years and had been chairman since June 1998.
I am pleased to be extending my role as a non-executive director
and taking over the role of Chairman. I am looking forward to being
involved as Oxford BioMedica enters a year of exciting opportunities.
IN SUMMARY
This has been
an excellent year for BioMedica. A great deal has been achieved,
and there is still more to come. However, none of this would have
been possible without the dedication and extraordinary skills of
our research and development staff or the support of our shareholders,
new and old. The Directors were particularly pleased to welcome
new institutional shareholders who took part in the two share placings
during 2000. The Board also extends its thanks to Alan Goodman for
his many contributions to the development of BioMedica over its
first four years
Dr Peter
Johnson
Chairman
Return to the News
Consolidated
profit & loss account
for the year ended 31 December 2000 |
| |
2000
(unaudited)
£000's |
1999
(unaudited)
£000's |
|
Turnover |
|
436
|
|
Research and development
Administrative expenses |
(5,033)
(1,731)
|
(3,764)
(1,346)
|
|
Operating expenses
Other operating income: government
grants receivable |
(6,764)
96 |
(5,110)
267
|
|
|
|
|
|
Net operating expenses |
|
(4,843)
|
|
Operating loss |
(5,936)
|
(4,407) |
|
Interest receivable |
541
|
218 |
|
Loss on ordinary
activities before taxation |
(5,395) |
(4,189) |
|
Tax credit on loss on ordinary
activities |
393 |
- |
|
Loss for the year |
(5,002)
|
(4,189)
|
|
Basic loss and diluted loss per ordinary share
|
(3.1p)
|
(3.0p) |
Consolidated
balance sheet
at 31 December 2000 |
| |
2000
(unaudited)
£000's |
1999
(unaudited)
£000's |
| Fixed
assets |
|
|
| Intangible
assets |
283
|
332
|
| Tangible
assets |
1,304
|
773
|
| Investments |
26
|
26
|
| |
|
|
| Current
assets |
|
|
| Debtors
|
1,069
|
432
|
| Cash
at bank and in
hand |
11,635
|
3,039
|
| |
|
|
| Creditors:
amounts
falling due within one
year |
(1,340)
|
(801)
|
| Net
current assets
|
|
|
| Net
assets |
12,977
|
3,801
|
| |
|
|
| Capital
and reserves |
|
|
| Called-up
share capital |
1,721
|
1,422
|
| Share
premium account |
26,428
|
12,549
|
| Other
reserves |
711
|
711
|
| Profit
and loss account
(deficit) |
(15,883)
|
(10,881)
|
| Equity
shareholders' funds |
|
|
Consolidated
cash flow statement
for the year ended 31 December 2000 |
| |
2000
(unaudited)
£000's |
1999
(unaudited)
£000's |
| Operating
activities |
|
|
| Net
cash outflow from continuing operating activities (reconciliation
to operating loss) |
(5,306)
|
(3,800)
|
|
Returns on investments
and servicing of finance
|
|
|
| Interest
received |
407
|
218
|
| Capital
expenditure |
|
|
| Purchase
of tangible fixed assets |
(683)
|
(136)
|
| Acquisitions
and disposals |
|
|
| Investment
in joint venture |
-
|
(26)
|
| |
|
|
| Net
cash outflow before management
of liquid resources and financing |
(5,582)
|
(3,744)
|
| Management
of liquid resources |
|
|
| Net
transfer to deposit accounts |
(11,092)
|
-
|
| Financing
|
|
|
| Issue
of ordinary shares |
14,603
|
3,556
|
| Expenses
of share issue |
(425)
|
(339)
|
| |
14,178
|
3,217
|
|
Decrease in cash in the year
|
(2,496)
|
(527)
|
| Reconciliation
of operating profit to net cash outflow from operating activities
|
|
|
| |
2000
(unaudited)
£000's |
1999
(unaudited)
£000's |
| Continuing
activities |
|
|
| Operating
loss |
(5,936) |
(4,407) |
Amortisation
on intangible
fixed assets |
49 |
49 |
| Depreciation
on tangible fixed assets |
321 |
296 |
| Loss
on disposal of tangible fixed assets |
5 |
1 |
| Decrease/(increase)
in trade debtors |
(24) |
(24) |
(Increase)/decrease
in other
debtors and other tax receivable |
(52) |
27 |
| Increase
in prepayments and accrued income |
(82) |
(77) |
| Increase
in trade creditors |
99 |
162 |
| Increase
in other taxation and social security |
57 |
29 |
| Increase
in accruals and deferred income |
209 |
144 |
| Net
cash outflow from continuing operating activities |
(5,306)
|
(3,800)
|
Notes to
accounts
- The preliminary
results for the year ended 31 December 2000 are unaudited and
do not constitute the Company's statutory financial statements
within the meaning of s227 of the Companies Act 1985. The financial
information for the year ended 31 December 1999 is derived from
the statutory accounts for that year which have been delivered
to the Registrar of Companies. The auditor's report on those accounts
was unqualified. The statutory accounts for the year ended 31
December 2000 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.
- The basic
loss per share has been calculated on a weighted average number
of shares of 161,851,789 in issue during the year (1999: 137,599,908).
The Company had no dilutive potential shares in either period
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.
- Copies of
this announcement are available from the Company Secretary. The
audited statutory financial statements for the year ended 31 December
2000 are expected to be distributed to shareholders by 28 February
2001 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 25 January
2001.
| For
further information please contact: |
|
|
Oxford BioMedica plc
Professor Alan
Kingsman, Chief Executive |
Tel:
+44 (0)1865 783 000 |
| City/Financial
Enquiries
David
Simonson, Melanie Toyne Sewell
Merlin Financial Communications |
Tel:
+44 (0)207 606 1244 |
| Scientific/Trade
Enquiries
Chris
Gardner, HCCDe Facto Group
|
Tel:
+44 (0)207 496 3300 |
|