Interim Results 2000
Oxford Biomedica PLC
16 August 2000
2000/OB/19
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 press Enquiries
Sue Charles /Katja Stout, HCC.De Facto Tel: +44 (0)207 496 3300
INTERIM RESULTS FOR THE
6 MONTHS ENDED 30 JUNE 2000
Oxford, England - 16 August 2000. Oxford BioMedica plc (AIM-OXB) today
announced its interim results for the 6 months to 30 June 2000. The key points
of the results are as follows:
Summary
. Income rose 77% to £344,000 (1999: £ 194,000);
. Loss before tax was £2.69 million (1999: £2.10 million);
. Cash balance at 30 June 2000 was £5.92 million, with net cash burn of £2.44
million for the first six months;
. £13.55 million new funds raised this year, comprising £5.05 million (net)
raised in January 2000 and a further £8.5 million (net) raised in August
2000;
. Clinical trials - MetXia-P450(TM) progressing through BC1 trial, with first
results of the study available shortly. TroVax(TM) is proceeding through
its regulatory approval process;
. Collaborations -
- Aventis: with respect to BioMedica's hypoxia response element, the
collaboration has been extended to include a second gene and a feasibility
study has been initiated for the use of the LentiVector(R) technology;
- Virbac SA: veterinary version of TroVax(TM) licensed and collaboration
making progress;
- Nycomed Amersham: agreement to develop a tumour imaging product to identify
patients most suited for treatment with TroVax(TM);
- Modex SA - ongoing collaboration to produce a novel diabetes therapy
achieving significant success;
- IDM - cell-based therapy collaboration making progress.
. New division - recently announced creation of new Gene Discovery Division
based on BioMedica's LentiVector(R) technology for target validation and
drug discovery programmes, and the new proprietary Smartomics(TM) technology
for new gene discovery. Data presented this week demonstrating the
identification of 23 new disease related genes using the Smartomics(TM)
technology;
. New Board appointment - Dr Paul Durrands appointed as Commercial Director of
Oxford BioMedica and Chief Operating Officer to the new Gene Discovery
Division;
Commenting on the results, BioMedica's CEO, Professor Alan Kingsman said:
'We have continued to follow our strategy of managing risk by seeking as many
commercial opportunities for our technology and product components as
possible, whilst retaining firm control on spending. This has been achieved
through creative deal structures and by pursuing internal product development
programmes. We have also used our core gene delivery technologies in the
field of gene discovery to enhance shareholder value.
'By the year end, we expect there to be further progress in the Gene Therapy
and Gene-based Immunotherapy programmes and that the Gene Discovery Division
will be fully up and running, and we look forward to reporting on these going
forward.'
Notes to Editors
1. Oxford BioMedica plc
Established in 1995, the Company specialises in the development and
application of gene-based therapeutics using advanced gene delivery
technologies for the treatment of disease in the areas of Oncology,
Immunotherapy, Neurobiology and Viral Infection. The Company raised £8.5m
through a placing on 9 August 2000 to fund its new Gene Discovery Division.
Oxford BioMedica plc was floated on the UK Alternative Investment Market of
the London Stock Exchange in December 1996.
2. Smartomics(TM)
Smartomics(TM) is a 'knowledge-based' system using BioMedica's gene delivery
systems to improve the output of genomic and proteomic screens. The technology
works by selectively amplifying the activity of disease-related genes. This
makes these important genes easier to identify and it provides more
information on their function. The improved screening process allows the rapid
identification of a more select group of genes, of which a much larger
proportion are relevant to a particular disease. This should provide a faster
route to product development, and products derived from the genes should be
patented more effectively. In short, the Directors of BioMedica believe that
Smartomics(TM) offers a powerful new route to extracting value from the
genomics field.
3. LentiVector(R) gene delivery systems
In gene therapy, the aim is to deliver a gene and its necessary regulatory
elements (the gene construct) to the cell surface, using a vector to mediate
the transfer across the cell membrane and, in some cases, into the nucleus. A
very powerful vector system is based on lentiviruses, which have similar
features to retroviruses in the ease of manipulation, predictable integration
and reliable gene expression and regulation. They do not take any viral genes
into the target cell, and no inflammatory or other side effect is detectable.
Their main advantage over retroviruses is the ability to function in
non-dividing cells or cells that are dividing slowly - a feature of many
clinically important tissues.
4. Worldwide web
This release is also available on the Worldwide Web at
http://www.oxfordbiomedica.co.uk
5. Interim statement
A full version of the statement from Oxford BioMedica's Chairman and Chief
Executive is attached below.
Extract from the Chairman's and Chief Executive's statement
The first half of 2000 has been a busy time for the Company with significant
progress being made on a number of fronts. The Directors have continued their
strategy of managing risk by placing BioMedica's technology and product
components into as many commercial opportunities as possible while retaining
firm control on spending. This has been achieved through creative deal
structures with both large and small companies as well as by pursuing internal
product development programmes. In addition, the Company has recently further
enhanced shareholder value by using its core gene delivery technologies in the
field of gene discovery through the formation of a new Gene Discovery
Division.
Clinical Developments
MetXia-P450(TM) is progressing well through the BC1 trial, a study in late
stage cancer patients with residual skin nodules. The trial is proceeding
according to plan and the first results from the dose ranging part of the
study will be available shortly. Earlier in the year the Company initiated
the OC1 trial, in which the product is being administered to ovarian cancer
patients.
TroVax(TM), the Company's lead immunotherapy product, is proceeding through
its regulatory approval process. It has received conditional approval by the
Gene Therapy Advisory Committee subject only to some non-technical revisions
to the protocol and patient information leaflet. The product has been
manufactured in preparation for the trial, TV1, to start at the end of the
year. The trial will test TroVax(TM) in patients suffering from colorectal
cancer and will be conducted at the Christie Hospital in Manchester. Although
there has been significant commercial interest in TroVax(TM), the Directors
have decided to fund the first trial from the Company's own resources in order
to increase the value of any future licensing deal with a pharmaceutical
company.
Preclinical Research and Development
The research and development pipeline in BioMedica goes from strength to
strength with significant developments in a number of areas. For example, in
the neurodegenerative disease programme the Company's gene transfer systems
for the brain were described at the Forum for European Neurosciences 2000
conference in June. The presentation was very well received and we anticipate
that contacts made at the conference will develop into collaborations in the
future involving the Company's Parkinson's disease product, ProSavin(R), and
other opportunities.
In the gene-based immunotherapy field, the Company has obtained preclinical
efficacy data using one of its proprietary anti-tumour antibodies. These data
are now the focus of early-stage discussions with a major pharmaceutical
company.
Product Collaborations
The Company's collaboration in cardiovascular disease with Aventis is making
good progress. In June BioMedica announced that the scope of the relationship
had expanded. In line with the original agreement, Aventis nominated a second
gene to be used in association with the Company's hypoxia response element in
cardiovascular disease. In addition, a new agreement was reached with Aventis
whereby it is conducting a feasibility study for the use of our gene delivery
technology in cardiovascular products. If successful, this could lead to a
further full commercial license agreement with associated access payments,
milestones and royalties.
In February and March two deals involving products related to TroVax(TM) were
signed. In the first of these a veterinary version of TroVax(TM) was licensed
to the major European veterinary company, Virbac S.A.. The goal of this
collaboration is to produce an anti-cancer immunotherapy for companion
animals. Many dogs, in particular, die of cancer and there is an increasing
willingness on the part of owners to pay significant sums to extend the life
of their pets. Therefore, there is substantial market potential. Revenues will
be shared with Virbac, who will meet the costs of product development.
In the second TroVax(TM)-related deal the Company agreed to Nycomed Amersham
developing a tumour-imaging product based on a proprietary antibody that
specifically recognises those tumours that should respond to TroVax(TM). This
is important on two counts. First, it provides BioMedica with another route to
revenues at no additional cost to the Company. Secondly, it provides a
diagnostic/prognostic product that will support the use of TroVax(TM) in the
market by identifying those patients that are most suited to the treatment.
The ongoing collaboration with Modex S.A. of Switzerland, aimed at producing a
novel diabetes therapy has achieved significant success in that BioMedica's
LentiVector(R) technology has now been specifically configured for the
product. In addition the Company has achieved high-level gene transfer to
b-islet cells from the pancreas.
In cell-based therapy, IDM and BioMedica are making progress in matching the
Company's MacroGen(R) technology to IDM's cell processor in a programme that
is aimed at taking a joint cell-based therapy into clinical trial as soon as
possible.
Gene Discovery
BioMedica has successfully established a strong gene therapy activity and a
very exciting gene-based immunotherapy programme. Both of these have products
in clinical development, a pipeline of future clinical products and
collaborations with both large and small companies. In February, BioMedica
signed an agreement granting AstraZeneca certain rights to use the Company's
LentiVector(R) technology, outside the fields of gene therapy and gene-based
immunotherapy, for its internal target validation and drug discovery
programmes. This was the second such deal that BioMedica had signed, the first
being an early agreement with Aventis, and it showed that there is a clear
commercial opportunity for the Company to generate short-term revenue from a
series of similar deals.
The key to the opportunity is the fact that the pharmaceutical industry, via
its various activities in genomics and proteomics, is identifying a very large
number of genes that are in some way linked to disease processes. The
challenge that they have now is to pinpoint those relatively few important
genes that are mechanistically linked to disease and are therefore worthy of
further substantial investment as part of a drug development programme. This
narrowing of focus is the process of target validation and it requires a range
of technologies including high efficiency, non-toxic gene transfer into
various model systems that mimic disease processes. BioMedica's LentiVector(R)
technology is ideally suited to meet this challenge. The recognition of this
opportunity prompted the Company to announce the formation of a Drug Discovery
Unit in February.
Since February, the scope for target validation deals has further increased
and the Company has completed the testing of a new gene discovery technology,
called Smartomics(TM), which has now been shown to accelerate the process of
identifying genes that are mechanistically linked to disease processes. The
Company has already used this technology to identify genes that may be active
in cancer, arthritis and cardiovascular disease and it has gene discovery
programmes in asthma and in neurodegenerative disease.
Smartomics(TM) has considerable potential to generate shareholder value via
patents covering a variety of genes and through collaborative agreements with
the pharmaceutical industry. In order to realise this potential BioMedica has
recently established a Gene Discovery Division that will have a headcount of
about 20 and will focus on maximising shareholder value in the important and
emerging field of genomics. The Company will not be competing directly with
the major genomics and proteomics companies but will, instead, be taking a
complementary, more focused approach to gene discovery. Indeed, some of the
larger genomics companies are potential partners in collaborations based on
Smartomics(TM) and LentiVector(R)-based target validation.
Intellectual Property
BioMedica continues to pursue its aggressive intellectual property strategy
and a number of new technologies have been acquired by the Company during the
first half of the year. In addition a number of our patents are now proceeding
through the US and European examination process. In February BioMedica was
awarded a US patent covering important aspects of gene transfer technology.
Further successful applications are expected in the coming year.
Changes to the Board
In March the Company was pleased announce that Dr Paul Durrands had agreed to
join the Board of Oxford BioMedica as Commercial Director with special
responsibility for new corporate opportunities. In addition, he has taken on
the role of Chief Operating Officer for the new Gene Discovery Division in
which he will be responsible for driving forward the commercial success of the
new activity.
Paul trained as a Chartered Accountant with Coopers & Lybrand and has a PhD in
Molecular Biology from the University of Bath. After qualifying as an
accountant he joined BOC's distribution division for 5 years in which time he
was involved in acquisitions and major contracts. He subsequently spent 3
years as Group Finance Director for the Pig Improvement Company (PIC), a
division of Dalgety, during which time he was involved in acquisitions and
expansion of the business worldwide. His most recent role was as Finance
Director of the joint venture between Yoplait and Dairy Crest (YDC), working
on the strategy and integration of the Raines Dairy Foods business acquired by
YDC.
Financing - £8.5M Placing
In August, subsequent to the half-year end, BioMedica completed a placing of
14.6 million shares at 60p per share thereby raising £8.5 million, net of
costs, to fund the new Gene Discovery Division. The Company made use of a
disapplication of pre-emption rights, approved at the last AGM to raise the
funds quickly and cost-effectively. Moving fast is essential in what is
generally regarded as a 'land-grab' race to identify the most important
disease related genes amongst those that comprise the human genome. New
developments in this field created the exceptional circumstances which led the
Directors to issue a limited number of shares without going through the usual
extended approval process. This is enabling the Company to quickly acquire
facilities and staff for the new Division.
BioMedica has always made clear its intention to move from AIM to the Official
List of the London Stock Exchange. When TroVax(TM) enters clinical trials the
Company will meet the performance criteria defined in Chapter 20 of The
Listing Rules. Assuming the TroVax(TM) programme stays on target and assuming
that market conditions are favourable, the Directors anticipate that a move to
the Official List may be possible in the first quarter of 2001. No firm
decision has been made, at this stage, about further fund raising at that
time.
Financial Performance
We continued throughout the first half of 2000 to maintain the financial
discipline that has characterised the period since BioMedica became a public
company in 1996. As a result of deals with Modex S.A., Virbac S.A.,
AstraZeneca and Nycomed Amersham, income was up 77% on the first half of 1999.
With increased research and development and clinical activity and in line with
our budget, operating expenses were up 28% on 1999. Grant income, mostly in
relation to the BC1 clinical programme, was lower than last year, while
interest earned on deposits was higher. The pre-tax loss was £2.69 million, an
increase of 28% on 1999. Following the introduction in April 2000 of R&D tax
relief, there is a tax credit of £110,000 leading to a retained loss of £2.58
million for the first half of 2000.
The cash balance at 30 June 2000 was £5.92 million. The cash burn of £2.44
million included the payment of £275,000 for rights to certain genes, for
which there was a corresponding receipt of £275,000 in respect of the issue of
shares. In addition, 13.7 million shares were placed at 38p per share in
January, raising net proceeds of £5.05 million.
Professor Alan Kingsman Alan Goodman
Chief Executive Chairman
Consolidated Profit & Loss Account
6 months 6 months Year
ended ended ended
30 June 30 June 31 December
2000 1999 1999
(unaudited) (unaudited) (audited)
£000's £000's £000's
Turnover 344 194 436
Research and development (2,507) (1,908) (3,764)
Administrative expenses (805) (689) (1,346)
Operating expenses (3,312) (2,597) (5,110)
Other operating income: government
grants receivable 85 181 267
Net operating expenses (3,227) (2,416) (4,843)
Operating loss (2,883) (2,222) (4,407)
Interest receivable 193 119 218
Loss on ordinary activities
before taxation (2,690) (2,103) (4,189)
Tax on loss on ordinary activities 110 - -
Loss for the period (2,580) (2,103) (4,189)
Loss and diluted loss per
ordinary share (1.7p) (1.6p) (3.0p)
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
2000 1999 1999
(unaudited) (unaudited) (audited)
£000's £000's £000's
Fixed assets
Intangible assets 307 357 332
Tangible assets 715 844 773
Investments 26 - 26
1,048 1,201 1,131
Current assets
Debtors: amounts falling due
within one year 708 497 432
Cash at bank and in hand 5,915 4,977 3,039
6,623 5,474 3,471
Creditors: amounts falling due
within one year (1,087) (788) (801)
Net current assets 5,536 4,686 2,670
Total assets less current
liabilities 6,584 5,887 3,801
Provisions for liabilities
and charges (43) - -
Net assets 6,541 5,887 3,801
Capital and reserves
Called-up share capital 1,564 1,422 1,422
Share premium account 17,727 12,549 12,549
Other reserves 711 711 711
Profit and loss account (deficit) (13,461) (8,795) (10,881)
Equity shareholders' funds 6,541 5,887 3,801
Consolidated Cash Flow Statement
6 months 6 months Year
ended ended ended
30 June 30 June 31 December
2000 1999 1999
(unaudited) (unaudited) (audited)
£000's £000's £000's
Operating activities
Net cash outflow from
continuing operating activities (2,547) (1,861) (3,800)
Returns on investments and
servicing of finance
Interest received 193 102 218
Capital expenditure and
financial investment
Purchase of tangible fixed assets (90) (47) (136)
Purchase of fixed asset investments - - (26)
(90) (47) (162)
Net cash outflow before management
of liquid resources and financing (2,444) (1,806) (3,744)
Management of liquid resources
Transfer to deposit accounts (7,740) (6,291) (6,291)
Transfer to current accounts 1,899 1,371 6,291
(5,841) (4,920) -
Financing
Issue of ordinary shares 5,481 3,556 3,556
Expenses of share issue (161) (339) (339)
5,320 3,217 3,217
Decrease in cash in the period (2,965) (3,509) (527)
Reconciliation of operating profit to net
cash outflow from operating activities
6 months 6 months Year
ended ended ended
30 June 30 June 31 December
2000 1999 1999
(unaudited) (unaudited) (audited)
£000's £000's £000's
Continuing activities
Operating loss (2,883) (2,222) (4,407)
Amortisation on intangible fixed assets 25 24 49
Depreciation on tangible fixed assets 152 144 296
Loss on disposal of tangible fixed assets 3 1 1
Increase in trade debtors (27) (45) (24)
(Increase)/decrease in other debtors and
other tax receivable (102) (20) 27
Increase in prepayments and accrued income (37) (57) (77)
Increase in trade creditors 6 210 162
(Decrease)/increase in other taxation and
social security (10) 8 29
Increase in accruals and deferred income 283 96 144
Increase in provisions for liabilities
and charges 43 - -
Net cash outflow from continuing
operating activities (2,547) (1,861) (3,800)
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 17 January 2000 the Company issued 13,700,000 new ordinary shares of 1p
each at 38p per share, raising cash proceeds of £5,206,000 before expenses. On
18 May 2000 the Company issued 500,000 new ordinary shares of 1p each at 55p
per share, raising cash proceeds of £275,000. Subsequent to the period end, on
9 August 2000 the Company issued 14,600,000 new ordinary shares of 1p each at
60p per share, raising cash proceeds of £8,760,000 before expenses.
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 1999 but have not been
reviewed by the auditors. The financial information relating to the year ended
31 December 1999 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 net loss for
the period by the weighted average number of 154,885,490 shares in issue
during the six months ended 30 June 2000 (six months ended 30 June 1999:
132,956,799, year ended 31 December 1999: 137,599,908).The Company had no
dilutive potential ordinary shares in any of the periods, and there is
therefore no difference between the loss per ordinary share and the diluted
loss per ordinary share.