Interim Results
Oxford Biomedica PLC
1 August 2001
For immediate release
2001/OB/14
1 August 2001
For further information, please contact:
Oxford BioMedica plc Tel: +44 (0)1865 783 000
Professor Alan Kingsman, Chief Executive
City/Financial Enquiries: Tel: +44 (0)20 7831 3113
Melanie Toyne Sewell/Fiona Noblet
Financial Dynamics
Scientific/Trade Press Enquiries: Tel: +44 (0)20 7496 3300
Chris Gardner, HCC*De Facto Group
OXFORD BIOMEDICA INTERIM RESULTS FOR
THE SIX MONTHS ENDED 30 JUNE 2001
Oxford, United Kingdom - 1 August 2001. Oxford Biomedica plc (LSE:OXB) today
announced its interim results for the six months to 30 June 2001. The key
points of the results are as follows:
Highlights
* Financing: Successful £35.5 million Placing and Open Offer, the
proceeds of which have allowed investment in staff, expansion of core
programmes and establishment of a US subsidiary, Biomedica inc. Admission to
the Main List of the London Stock Exchange.
* Financial Performance: Turnover for the period £0.3 million (2000: £
0.3 million), loss after tax £3.6 million (2000: £2.6 million). Cash in the
bank at 30 June 2001 was £39.9 million, in line with budget.
* Commercial development: Collaborative product development deal with
American Home Products/Wyeth, with a headline value of $24 million, started in
January 2001 and is making good progress. Other ongoing collaborations with
Nycomed Amersham, Virbac S.A., IDM and Aventis are progressing well.
* Gene Discovery: Business development programme initiated, with 15
potential partners in discussion. Two of these, Millenium and Biogen have
progressed to feasibility studies.
* Clinical development: Expansion of MetXia(R) clinical development
programme to include two new formulations. To date, MetXia(R) has proven to
be safe and has demonstrated positive gene transfer, thereby achieving primary
goals of trial. TroVaxTM clinical programme started and is on track with one
third of patients enrolled.
* Preclinical development: Initiation of clinical development for
ProSavin(R) and BetOvaC(R), expected for the end of 2002. ProCaStat(R)
(prostate cancer) has moved into the preclinical phase with a planned
accelerated clinical development programme.
* Therapeutic research: Important developments, in particular two in
neurobiology - one with the method of the delivery of genes to neurons and the
other through a collaboration with Kings College, London, with respect to a
gene which induces new nerve growth.
* Gene discovery: Successful application of Smartomics(R) to target
discovery. Discovery of 250 potential new targets for the treatment of
stroke, heart disease, rheumatoid arthritis and atherosclerosis.
* Intellectual property: Nine new applications filed, three
applications moved to the international phase and nine new patents granted.
Commenting on the interim results, Dr Peter Johnson, Chairman of Oxford
BioMedica said:
'This period has seen the further transformation of Oxford BioMedica into a
broad-based gene technology company with financial stability and strong
commercial collaborations. We completed a successful fundraising in April
which has allowed us to establish a US subsidiary, increase our staffing
levels and accelerate several of our key programmes, in particular for
neurobiology and ProCaStat(R). We continue to focus on building our product
pipeline and are pleased with the progress we have made during the period.'
-Ends-
Oxford BioMedica's move to the Official List of the London Stock Exchange is
the culmination of four years of successful growth and development.
The most significant event for BioMedica in the first half of 2001 was the
fundraising and move to the Official List of the London Stock Exchange that
was completed in April. The Company raised £35.5 million before costs from a
placing and open offer, despite the difficult market conditions at the time.
This was a landmark event in BioMedica's development. We were able to achieve
it because of the Company's excellent achievements and potential that we were
able to present to existing and prospective shareholders. The strong position
we now find ourselves in is the direct product of our dedicated and talented
technical, commercial and business development teams. Credit for this
achievement also goes to our team of advisors.
Commercial Developments
Therapeutics
In January, the Company announced a new collaborative product development deal
with American Home Products/Wyeth. The contract had a headline value of $24
million in access and milestone payments, and in addition, royalties on sales
of the product. This is a good illustration of BioMedica's versatile and
creative commercial strategy. The subject of the deal is a spin-off from the
Company's TroVaxTM tumour vaccine programme. As part of the TroVaxTM
technology, the Company had an antibody (OBA1-H8) directed against the tumour
antigen (protein) that is delivered by TroVaxTM. Because that antigen is
present on a wide range of tumour cells and is not present on normal tissue,
the antibody directed against it is potentially a valuable therapeutic agent.
The team that produced Wyeth's Mylotarg product for leukaemia considered
BioMedica's OBA1-H8 antibody to be an ideal candidate for a Mylotarg-like
product but with, perhaps, broader use in a wide range of cancers. This
concept forms the basis of the deal. The development programme started in
January and is already making good progress.
The OBA1-H8 imaging project with Nycomed-Amersham is progressing well and the
TroVaxTM-Vet collaboration with Virbac S.A. has achieved its initial goal of
demonstrating that the animal version of OBA-1 is present on a number of
canine and feline tumours.
BioMedica and its partner IDM have now identified defined clinical strategies
for TroVaxTM-DC and MetXia(R)-MG (previously described as MacroGen-CYP2B6).
Protocols and clinical strategies for these two products are being drafted
with the first trials planned for the second half of 2002.
The cardiovascular collaboration with Aventis continues, including the ongoing
evaluation of BioMedica's LentiVector(R) system for the delivery of angiogenic
factors. There has been some reorganisation within Aventis and the changes in
the management of their Gencell operation. The new Gencell organisation has an
increased focus on gene therapy to treat cardiovascular disease, the subject
of the collaboration.
Other collaborations are proceeding according to plan and there are several
new contracts, at various stages, under discussion.
Gene Discovery
Following the £8.5 million Gene Discovery fundraising last August the Gene
Discovery Division has been assembling its marketing data and documentation.
The business development programme was then initiated in earnest in April.
This has already been successful, with currently 15 potential partners at
various stages of discussion. Two of these, Millennium and Biogen, have
already progressed to feasibility studies and the Company is optimistic that
these and other interactions should lead to gene discovery deals later this
year.
Clinical Development
We continue to make good progress in our clinical programmes.
MetXia(R)
The MetXia(R) clinical development programme is expanding to include two new
formulations. The first of these has obtained ethical approval from GTAC and
will be evaluated as part of the current breast cancer clinical programme. The
second, MetXia(R)-MG, is being developed in collaboration with IDM for use in
all peritoneal cancers (ovarian, bladder, pancreatic, colorectal and stomach
cancers) and we anticipate that it will enter clinical development in
mid-2002. This will broaden the data that we are obtaining from the ongoing
OC1 ovarian cancer trial.
The ability to vary the configuration and formulation during an early clinical
development programme highlights one of the strengths of the gene therapy
approach and allows the product to be enhanced prior to larger scale and more
expensive testing. To date MetXia(R) has been proven to be safe and has given
positive gene transfer to breast and ovarian tumours and melanomas. This
means that the primary goals of these trials have been achieved.
TroVaxTM
The TroVaxTM clinical programme in colorectal cancer is progressing as
predicted with one third of the patients now enrolled. The trial is on track
to deliver preliminary results early in 2002. The Company already anticipates
building on this programme with a cell-based formulation, TroVaxTM-DC, in
collaboration with IDM in 2002.
Preclinical Development
Several of the Company's products are moving successfully through the
preclinical phase. ProSavin(R), a treatment for late stage Parkinson's disease
and BetOvaC(R), a gene-based immunotherapy for ovarian cancer, are progressing
through preclinical development as predicted and should both begin clinical
development by the end of 2002.
ProCaStat(R), a lentiviral based gene therapy for prostate cancer, moved into
the preclinical phase during early 2001. This product is expected to
outperform other vector systems in this particular cancer type because of
advances that we have made in gene delivery and in the therapeutic gene. The
ProCaStat(R) clinical development programme is being accelerated and it is now
planned to be submitted for regulatory approval in early 2002 with a view to
starting a clinical programme in the latter half of 2002.
The ImmStat(R) AIDS product remains on hold, but it is ready to move into a
clinical development programme. Discussions around ImmStat(R) are ongoing with
a potential partner.
Therapeutic Research
There have been several important developments in the Company's hypoxia and
ischaemia research programme, and in immunotherapy and neurobiology. Two areas
in the field of neurobiology are worthy of special mention. Over the past two
years, BioMedica has been developing technologies for the selective delivery
of genes to neurones based on the LentiVector(R) system. A key part of this
technology has been the ability to modify the surface of the gene delivery
particles for specific purposes. One of the most exciting developments has
been the construction of a system that enables the Company to deliver genes to
the central nervous system by the relatively non-invasive injection of
peripheral sites. This technology provides opportunities in both therapy for
peripheral neuropathies and pain, and in gene discovery.
The other noteworthy development comes from the collaboration with King's
College in London. BioMedica has acquired the rights to use a gene, identified
by the King's team, which induces new nerve growth. Initial results in which
this gene is delivered using the Company's LentiVector(R) system suggest that
it may be possible to develop products for nerve repair. This has substantial
commercial potential, as there are no products currently available for nerve
injury or peripheral neuropathies.
Gene Discovery
The Gene Discovery Division has successfully applied BioMedica's proprietary
Smartomics(R) to target discovery, using the Company's gene transfer
technologies to uncover novel parts of disease-related biological pathways.
The Company has protected, in five patent applications, more than 250
potential new targets for the treatment of stroke, heart disease, rheumatoid
arthritis and atherosclerosis. Our gene transfer technology opens the way to
various validation assays, which are crucially important to prove the
relevance of targets to the development of new therapies. BioMedica has
provided this technology to several other companies including Aventis,
AstraZeneca, Millennium and Biogen, and it has been applied to the validation
of the Company's own targets. A number of targets are progressing through
validation. One gene in particular, which the Company has shown to be
implicated in ischaemic disease, seems to play a role in programmed cell death
in the brain. It may be possible to improve the survival of brain cells after
stroke by targeting this gene with drugs which reduce its effect on cell
death.
Intellectual Property
BioMedica recognises the importance of a strong patent portfolio, and we are
pleased to report a number of significant developments. Nine new patent
applications have been filed, three applications have gone to the
international phase and nine have been granted. The granted patents have been
in the fields of LentiVector(R), retroviral vectors, Parkinson's disease
therapy, MacroGen(R), the control of gene function by oxygen and HIV therapy.
The most significant of these are the LentiVector(R) patents which give
BioMedica a strong position in this key field.
BioMedica Inc.
Following the fundraising in April, Oxford BioMedica established BioMedica
Inc. in California. The Company was delighted to appoint Dr. Doug Jolly as the
CEO of the new subsidiary. Doug has been in the field of gene therapy for more
than 15 years. He has managed a number of clinical trials, he is an advisor to
the US Food and Drug Administration (FDA) and National Institutes of Health,
he has founded his own company, Viagene, and taken it to a Nasdaq listing.
Chiron subsequently acquired Viagene, and Doug then joined Chiron as Vice
President for Scientific Affairs. He is a well known figure in the field, and
he is already having an impact on business development in the USA.
BioMedica Inc. will move into temporary facilities in September 2001 and into
a permanent building next year. Initial goals will be to refine the Company's
LentiVector(R) production technology and to expand the neurobiology
opportunities. In addition BioMedica Inc. will act as a focal point for
commercial interactions in North America and it will start to build a strong
relationship with the FDA as BioMedica begins to conduct clinical trials in
the USA.
Financial
In April, in conjunction with the move from AIM to the London Stock Exchange
Official List, BioMedica concluded a placing and open offer, raising £35.5
million before expenses. A total of 64.5 million new shares were issued at 55p
per share. 59.2 million shares were placed with financial institutions, and
5.3 million shares were taken up in the open offer. Net of costs, the placing
and open offer raised £32.3 million. Subsequent to the placing and open offer,
the Company's advisor N.M. Rothschild & Sons Limited subscribed £250,000 at
the placing price.
In addition, the Company issued 204,360 shares in February to King's College
in a £150,000 subscription in connection with the acquisition of rights to use
the RARb2 gene, and in April issued 102,900 shares at 15.5p per share on the
exercise of share options.
The proceeds of the placing and open offer have allowed BioMedica to increase
its staff and to expand several of its programmes. At 30 June 2001 the
headcount was 71, including three at BioMedica Inc., the newly-formed United
States subsidiary. During the first half of 2001 BioMedica renewed the lease
on its 11,000 sq.ft. facilities on the Oxford Science Park, and took out
leases on a further 17,000 sq.ft., also on the Science Park. Part of the new
space is being fitted out as state-of-the-art laboratories. This expansion in
staff and facilities was planned alongside the placing and open offer and was
within budget.
As a result of increased activities, the loss after tax for the first half of
2001 was £3.6 million, an increase of 39% on the same period last year.
Revenue was £0.3 million (2000: £0.3 million), and net operating expenses were
£5.0 million compared to £3.2 million in 2000. As a result of the increased
cash balance following the placing and open offer, interest receivable was
substantially higher at £0.6 million (2000: £0.2 million). The R&D tax credit
for 2001 was £0.4 million. The credit of £0.1 million in 2000 covered a three
month period following the introduction of the tax credit in April 2000.
Fixed asset additions of £1.5 million in 2001 included £0.8 million on
configuring the new labs and offices, and £0.5 million for lab equipment.
The bank balance at 30 June 2001 was £39.9 million, in line with the budget.
In Closing
BioMedica has continued to grow in its product pipeline, its technical
capabilities and its commercial interactions. The staff are to be
congratulated on another successful period in the Company's history. We thank
our loyal shareholders for their continued support and we welcome our new
shareholders from the April fundraising. The Company will continue to strive
to deliver shareholder value.
Professor Alan Kingsman Dr. Peter Johnson
Chief Executive Officer Chairman
Consolidated Profit & Loss Account
6 months 6 months Year
ended ended ended
30 June 30 June 31
December
2001 2000 2000
(unaudited) (unaudited) (audited)
£000's £000's £000's
Turnover 347 344 732
Research and development (3,755) (2,507) (5,033)
Administrative expenses (1,236) (805) (1,731)
Operating expenses (4,991) (3,312) (6,764)
Other operating income: government 14 85 96
grants receivable
Net operating expenses (4,977) (3,227) (6,668)
Operating loss (4,630) (2,883) (5,936)
Interest receivable 611 193 541
Interest payable (1) - -
Loss on ordinary activities before (4,020) (2,690) (5,395)
taxation
Tax on loss on ordinary activities 435 110 393
Loss for the period (3,585) (2,580) (5,002)
Loss and diluted loss per ordinary (1.8p) (1.7p) (3.1p)
share
The results for the above periods are derived entirely from continuing
operations.
The Group has no recognised gains and losses other than the above results, and
therefore no separate statement of total recognised gains and losses has been
presented.
There is no difference between the loss on ordinary activities before taxation
for the periods stated above, and their historical cost equivalents.
Consolidated Balance Sheet
As at As at As at
30 June 30 June 31
December
2001 2000 2000
(unaudited) (unaudited) (audited)
£000's £000's £000's
Fixed assets
Intangible assets 258 307 283
Tangible assets 2,445 715 1,304
Investments 26 26 26
2,729 1,048 1,613
Current assets
Debtors: amounts falling due within 1,622 708 1,069
one year
Cash at bank and in hand 39,853 5,915 11,635
41,475 6,623 12,704
Creditors: amounts falling due (2,059) (1,087) (1,340)
within one year
Net current assets 39,416 5,536 11,364
Total assets less current 42,145 6,584 12,977
liabilities
Provisions for liabilities and - (43) -
charges
Net assets 42,145 6,541 12,977
Capital and reserves
Called-up share capital 2,374 1,564 1,721
Share premium account 58,528 17,727 26,428
Other reserves 711 711 711
Profit and loss account (deficit) (19,468) (13,461) (15,883)
Equity shareholders' funds 42,145 6,541 12,977
Consolidated Cash Flow Statement
6 months 6 months Year
ended ended ended
30 June 30 June 31
December
2001 2000 2000
(unaudited) (unaudited) (audited)
£000's £000's £000's
Operating activities
Net cash outflow from continuing
operating activities
(reconciliation to operating loss on (3,969) (2,547) (5,306)
page 9)
Returns on investments and servicing
of finance
Interest received 521 193 407
Interest paid (1) - -
520 193 407
Capital expenditure and financial
investment
Purchase of tangible fixed assets (1,151) (90) (683)
Net cash outflow before management
of liquid resources and financing (4,600) (2,444) (5,582)
Management of liquid resources
Transfer to deposit accounts (43,282) (7,740) (14,729)
Transfer to current accounts 14,679 1,899 3,637
(28,603) (5,841) (11,092)
Financing
Issue of ordinary shares 35,909 5,481 14,603
Expenses of share issue (3,091) (161) (425)
32,818 5,320 14,178
Decrease in cash in the period (385) (2,965) (2,496)
Reconciliation of operating loss to
net cash outflow from operating
activities
6 months 6 months Year
ended Ended ended
30 June 30 June 31
December
2001 2000 2000
(unaudited) (unaudited) (audited)
£000's £000's £000's
Continuing activities
Operating loss (4,630) (2,883) (5,936)
Amortisation on intangible fixed 25 25 49
assets
Depreciation on tangible fixed 318 152 321
assets
Loss on disposal of tangible fixed 1 3 5
assets
Decrease in debtors falling due 37 - -
after more than one year
(Increase)/Decrease in trade debtors - (27) 24
Increase in other debtors and other (5) (102) (52)
tax receivable
Increase in prepayments and accrued (60) (37) (82)
income
Increase in trade creditors 146 6 99
(Decrease)/Increase in other (30) (10) 57
taxation and social security
Increase in accruals and deferred 229 283 209
income
Increase in provisions for - 43 -
liabilities and charges
Net cash outflow from continuing (3,969) (2,547) (5,306)
operating activities
Notes
1. Copies of this statement are being sent to all shareholders. Copies are
also available at the registered office of the Company, Medawar Centre,
Oxford Science Park, Oxford OX4 4GA.
2. On 5 February 2001 the Company issued 204,360 new ordinary shares of
1p each at 73.4p per share, raising cash proceeds of £150,000. On 12 April
2001 the Company issued 64,532,359 new ordinary shares of 1p each at 55p
per share, raising cash proceeds of £35,493,000 before expenses. On 30
April 2001 the Company issued 102,900 new ordinary shares of 1p each at
15.5p per share, raising cash proceeds of £16,000. On 22 May 2001 the
Company issued 454,545 new ordinary shares of 1p each at 55p per share,
raising cash proceeds of £250,000.
3. The interim results are unaudited and do not constitute statutory
accounts within the meaning of section 240 of the Companies Act 1985. The
interim results are prepared in accordance with the accounting policies set
out in the Report and Accounts for the year ended 31 December 2000 but have
not been reviewed by the auditors. The financial information relating to
the year ended 31 December 2000 has been extracted from the full report and
accounts for that period which have been filed with the Registrar of
Companies. The report of the auditors on those accounts was unqualified.
4. The basic loss per share has been calculated by dividing the loss for
the period by the weighted average number of 200,765,989 shares in issue
during the six months ended 30 June 2001 (six months ended 30 June 2000:
154,885,490, year ended 31 December 2000: 161,851,789). The Company had no
dilutive potential ordinary shares in any of the periods 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.