Interim Results
Oxford Biomedica PLC
20 September 2005
FOR IMMEDIATE RELEASE 20 SEPTEMBER 2005
OXFORD BIOMEDICA PLC INTERIM RESULTS
FOR THE SIX MONTHS ENDED 30 JUNE 2005
Oxford, UK: 20 September 2005 - Oxford BioMedica (LSE: OXB), the leading gene
therapy company, announced today its interim financial results for the six
months ended 30 June 2005. Year to date highlights:
Oncology
• Encouraging Phase II results with TroVax(R) and chemotherapy in
colorectal cancer presented at American Society of Clinical Oncology
meeting
• Further data from Phase II trials with TroVax to be presented at
International Colorectal Cancer Congress from 14 to 16 October 2005
• First stage of Phase II trial with MetXia(R) in pancreatic cancer
successfully concluded
• Wyeth expects to start trials in next 12 months with Oxford BioMedica's
5T4 antibody targeted therapy for solid tumours
• Intervet expects to start trials in next 12 months with Oxford
BioMedica's TroVax-Vet(R) in dogs with naturally occurring cancer
Neurotherapy
• Preparations for clinical trials of ProSavin(R) progressed. Phase I/II
trial in Parkinson's disease anticipated to start in 2006
• Preclinical efficacy data with RetinoStat(R) for age-related macular
degeneration presented at Association for Research in Vision and
Ophthalmology meeting
• New grant received for MoNuDin(R) from UK Motor Neuron Disease
Association for amyotrophic lateral sclerosis
• Preclinical efficacy data with Innurex(R) for spinal cord injury
presented at American Society of Gene Therapy meeting
Technology Licensing
• New license agreements signed with Pfizer and a leading
biopharmaceutical company for LentiVector(R) technology
• LentiVector licensee, Viragen, reached a milestone in development of an
avian transgenic biomanufacturing system.
Financial
• Cash, cash equivalents and short term investments at 30 June 2005 of
£18.6 m
• R&D costs lower than last year at £4.8 m (H1 2004: £5.2 m)
• Net decrease in cash and short term investments lower than last year at
£3.8 m (H1 2004: £5.6 m)
Commenting on the interim results, Professor Alan Kingsman, Chief Executive of
Oxford BioMedica, said: 'Oxford BioMedica has made good progress during the year
to date. Clinical results with the lead products have been highly encouraging
and our preclinical candidates in both oncology and neurotherapy have similarly
progressed. The next 12 months could see three pipeline products start clinical
trials. Technology licensing has attracted two new partners in the first half of
the year. Signing new collaborations on our technologies and also our
development products is a key focus for the company in the next 12 months.'
-Ends-
Today's web cast:
Simultaneously to the analyst briefing at 10.00 am on Tuesday 20 September 2005,
there will be a live audio web cast of the results presentation.
To connect to the web cast facility, please go to the Company's website: http://
www.oxfordbiomedica.co.uk/ approximately 10 minutes (09:50 am) before the start
of the briefing. This will also be available for replay shortly after the
presentation.
For further information, please contact:
Oxford BioMedica plc:
Professor Alan Kingsman, Chief Executive Tel: +44 (0)1865 783 000
City/Financial Enquiries:
Lisa Baderoon/ Mark Court/ Mary-Jane Johnson
Buchanan Communications Tel: +44 (0)20 7466 5000
Scientific/Trade Press Enquiries:
Sue Charles/ Katja Stout/ Ashley Lilly
Northbank Communications Tel: +44 (0)20 7886 8150
Notes to editors
Oxford BioMedica
Oxford BioMedica (LSE: OXB) is a biopharmaceutical company specialising in the
development of novel gene-based therapeutics with a focus on the areas of
oncology and neurotherapy. The Company was established in 1995 as a spin out
from Oxford University, and is listed on the London Stock Exchange.
Oxford BioMedica has core expertise in gene delivery, as well as in-house
clinical, regulatory and manufacturing know-how. In oncology, the pipeline
includes an immunotherapy and a gene therapy in multiple Phase II trials, and a
preclinical targeted antibody therapy in collaboration with Wyeth. In
neurotherapy, the Company's lead product is a gene therapy for Parkinson's
disease, which is expected to enter clinical trials in 2006, and four further
preclinical candidates. The Company is underpinned by over 80 patent families,
which represent one of the broadest patent estates in the field.
The Company has a staff of approximately 65 split between its main facilities in
Oxford and its wholly owned subsidiary, BioMedica Inc, in San Diego, California.
Oxford BioMedica has corporate collaborations with Wyeth, Intervet, Viragen,
MolMed and Kiadis; and has licensed technology to a number of companies
including Merck & Co, Biogen Idec and Pfizer.
Further information is available at http://www.oxfordbiomedica.co.uk
Chairman's and Chief Executive's Report
The first half of 2005 has been an exciting period for Oxford BioMedica,
dominated by encouraging Phase II results with TroVax(R) in colorectal cancer.
Other major milestones include successful completion of the first stage of the
Phase II trial with MetXia(R) in pancreatic cancer, reported in August, and
preclinical efficacy data with RetinoStat(R) in age-related macular degeneration
and with Innurex(R) in spinal cord injury. ProSavin(R) for Parkinson's disease
is progressing towards clinical trials, as are the two partnered cancer products
with Wyeth and Intervet.
Commercial discussions are ongoing for a number of Oxford BioMedica's lead
product candidates. Technology licensing has also flourished following the
partnering initiative implemented last year. In the first half of 2005, the
company secured two new licensees, including Pfizer, for its LentiVector(R)
technology. Another licensee, Viragen, achieved a key development milestone
using the LentiVector system for avian transgenic biomanufacturing.
Oncology
Oxford BioMedica's oncology pipeline comprises three major product candidates as
well as a product for treating cancer in companion animals. Clinical results
reported since the beginning of the year with the company's lead oncology
products, TroVax and MetXia, have met or exceeded expectations.
Data from three Phase II trials with TroVax in colorectal cancer have confirmed
the product's excellent safety profile and ability to stimulate an anti-cancer
immunological response. In the Phase II trials with concomitant chemotherapy,
the majority of patients showed tumour responses in parallel with the
anti-cancer immunological effect of TroVax. These interim data were presented at
the American Society of Clinical Oncology in May 2005. The company expects to
report further results from these two trials at an oncology conference later in
2005.
The first stage of the Phase II trial with MetXia in pancreatic cancer was
successfully concluded, demonstrating product safety, gene transfer at the
tumour site and identification of the optimal dose. The second part of the trial
is underway and initial efficacy results are expected in early 2006.
The cancer products in development through collaborations with Wyeth and
Intervet continue to progress. The 5T4 targeted antibody therapy for solid
tumours with Wyeth, and TroVax-Vet(R) for canine and feline tumours with
Intervet, are both anticipated to enter clinical trials in the next 12 months.
TroVax(R)
TroVax is Oxford BioMedica's advanced cancer immunotherapy product. It is
designed to stimulate an anti-cancer immune response and has potential
application in most solid tumour types. TroVax targets the tumour antigen 5T4,
which is broadly distributed throughout a wide range of solid tumours. The
product consists of a pox virus (MVA) gene transfer system, which delivers the
gene for 5T4. MVA is known to induce the breaking of immune tolerance to
self-antigens that are expressed from this gene delivery system.
All patients have reached the evaluation stage in the two Phase II trials with
TroVax in combination with chemotherapy in colorectal cancer. A further Phase II
trial in colorectal cancer in patients with operable liver metastases is
ongoing, under the sponsorship of Cancer Research UK. The first trial of TroVax
in renal cell carcinoma, which is being conducted in the United States,
continues to recruit patients and further trials in this disease setting are
planned.
The US National Cancer Institute (NCI) and the clinical trials consortium,
Southwest Oncology Group (SWOG), are finalising the design of a Phase II trial
with TroVax in breast cancer. These organisations provide valuable funding and
endorsement of TroVax and plan to conduct a trial that is expected to enrol 120
patients with late stage breast cancer. The NCI and SWOG are responsible for all
aspects of the trial including the date of commencement. The current expectation
is for the trial to start in 2006.
The most significant event of the first half of 2005 was the release of interim
results from the two Phase II trials of TroVax in first line treatment of
metastatic colorectal cancer alongside irinotecan-based (IFL) and
oxaliplatin-based (FOLFOX) chemotherapy. The data were presented at the 2005
American Society of Clinical Oncology (ASCO) Annual Meeting, in Orlando, Florida
, USA, in May.
The presentation included the headline data, reported in March 2005, and further
analysis of patients' immune responses and clinical benefit. There were 36
patients recruited across both trials. The interim results comprised data on
patients that had reached the evaluation stage, which amounted to 25 patients
for immunological analysis and 19 patients for assessment of clinical benefit.
As reported in March, the primary endpoints in the two trials of safety and
immunological responses were achieved. All 25 patients showed an immune response
to the 5T4 tumour antigen. In addition, the secondary endpoint of clinical
benefit exceeded expectation. Eighteen of 19 evaluable patients responded to
treatment, showing either complete or partial tumour shrinkage, or disease
stabilisation following treatment. Although the trial was small, in terms of
patient numbers, and was not designed with a control arm, this level of clinical
benefit was encouraging when compared to published trial data for chemotherapy
alone in similar settings.
The presentation at ASCO showed that the maximum antibody levels (titres)
targeted against the 5T4 tumour antigen in the Phase II trials were
significantly higher than in the earlier Phase I/II trial in post chemotherapy
patients. This may be important because, in that earlier study, there was a
highly significant (p<0.0001) correlation between antibody titre and time to
disease progression amongst responders. In addition, analysis of the anti-5T4
cytotoxic T-cell (CD8) response following immunisation with TroVax, showed
levels in some patients as high as 1 in 1,000 white blood cells. This level is
comparable with those seen in response to viral infections. Interestingly, in
the TroVax plus FOLFOX trial, the two patients that showed complete tumour
responses (tumour clearance) had the highest antibody and killer T-cell levels.
This associates, as in the Phase I/II trial, the anticancer immunological effect
of TroVax immunisation with clinical benefit.
The trials are on track to report full safety and immunological data as well as
final audited tumour response statistics before the end of 2005. The company
expects to present further data from the trials at the International Colorectal
Cancer Congress in Aventura, Florida, USA, from 14 to 16 October 2005. Patient
survival data will be reported in 2006.
Initial data from the first Phase II trial of TroVax in renal cell carcinoma are
expected later in 2005. Oxford BioMedica believes that renal cell carcinoma may
represent a commercially compelling opportunity for the development of TroVax.
The development plan for TroVax is emerging as the company accumulates data from
the current Phase II trials. The objective will be to achieve product
registration for TroVax in the United States by 2009. In preparation for product
registration, the manufacturing process has been scaled for commercial
production of TroVax.
The company expects to provide a comprehensive update later in the year on the
development status of TroVax, including data in renal cell carcinoma, further
data from the colorectal cancer trials and strategies for taking TroVax through
to product registration.
5T4 Targeted-Antibody Therapy
Wyeth is developing a targeted therapy for the treatment of cancer using a
humanised version of Oxford BioMedica's anti-5T4 antibody conjugated to a
cytotoxic molecule, calicheamicin. The product is a 'magic bullet' approach,
which is designed to deliver the conjugate directly and specifically to tumour
cells, sparing healthy cells. The collaboration with Wyeth is potentially worth
$24 million in upfront and milestone payments plus royalties. In the first half
of 2005, preparations for clinical trials have continued, which are anticipated
to start in the next 12 months.
TroVax-Vet(R)
TroVax-Vet is a veterinary version of TroVax that uses a canine or feline form
of the 5T4 gene for treatment of cancer in dogs and cats. Oxford BioMedica is
developing TroVax-Vet in collaboration with Intervet, which is a unit of Akzo
Nobel of Arnhem, the Netherlands. Under the collaboration, Intervet funds the
programme and Oxford BioMedica will receive development milestones and royalties
on sales.
Intervet and Oxford BioMedica completed a relevant preclinical efficacy study
with canine TroVax-Vet in the first half of 2005. Data from the recent study
demonstrate that the product stimulates a strong immune response against the
canine version of 5T4. Further product optimisation is planned prior to the
anticipated start of clinical trials in dogs with naturally occurring cancer in
the next 12 months.
MetXia(R)
MetXia is Oxford BioMedica's lead gene-based cancer therapeutic. The product
comprises a highly engineered retrovirus that delivers a specific human
cytochrome P450 gene to tumour cells. The enzyme encoded by the P450 gene
activates the commonly used cancer chemotherapy drug, cyclophosphamide (CPA), to
a form that destroys dividing cells. MetXia converts the tumour into a 'drug
factory', enabling local production of the anti-tumour, cytotoxic derivative of
CPA.
The initial indication for the development of MetXia is the treatment of
pancreatic cancer through direct administration of both MetXia and CPA to the
tumour. A two-stage Phase II trial was initiated in 2004. In August 2005, the
company announced that the first stage was successfully completed. The
objectives were to assess the safety of administering MetXia locally to the
pancreatic tumour, to confirm gene transfer at the tumour site following local
delivery and to identify an optimal dose for the second stage of the trial.
In the first stage of the trial, two dose levels of MetXia were assessed in six
patients in combination with a low dose of CPA. Each patient had two
administrations of MetXia, prior and subsequent to surgery, followed by CPA.
Both dose levels of MetXia were safe and well tolerated. Importantly, dose
dependent expression of the specific human cytochrome P450 gene, delivered by
MetXia, was observed in tumour biopsies taken at surgery.
Patient recruitment is underway for the second stage with a fixed dose of MetXia
and increasing doses of CPA, in up to 25 patients, which will determine the
optimal dose of CPA. This second stage of the trial is designed to evaluate
clinical benefit as well as safety. An additional clinical trial site in London
is expected to open, which will boost patient accrual. Preliminary efficacy data
are expected in early 2006.
The company plans to open discussions with the regulatory authorities to
determine the most expeditious route to obtain approval of MetXia. A pivotal
trial in pancreatic cancer could start in 2007, subject to successful completion
of the current Phase II trial.
Neurotherapy
Oxford BioMedica's neurotherapy pipeline comprises five therapeutic candidates
that utilise the company's LentiVector gene delivery technology. All five
programmes continue to meet expectations in their ongoing preclinical
development. The company is preparing regulatory submissions for the start of
clinical trials with the most advanced product, ProSavin for Parkinson's
disease. Given the commonality of the LentiVector system to all the neurotherapy
products, the infrastructure for ProSavin that relates to manufacturing scale-up
and safety testing can be applied to the entire portfolio. Hence, the time
invested in the preclinical development of ProSavin should accelerate the
programmes for the other development candidates. The company anticipates
entering clinical development with at least one neurotherapy product each year
from 2006, starting with ProSavin.
In the first half of 2005, the company reported encouraging preclinical efficacy
data for two neurotherapy pipeline products: RetinoStat for the treatment of
age-related macular degeneration and Innurex for spinal cord injury. In
addition, data from a proof of principle preclinical study for delivery of short
interfering RNA using the LentiVector technology was published in Nature
Medicine (see section on Research and Other Programmes).
The neurotherapy portfolio has attracted support from a number of charitable
organisations, primarily because the products offer the potential of safe and
effective treatment options for diseases with unmet medical need. In July 2005,
Oxford BioMedica was awarded a new grant from the UK Motor Neuron Disease
Association for its product candidate MoNuDin(R) for the treatment of
amyotrophic lateral sclerosis.
ProSavin(R)
The company's lead neurotherapy product, ProSavin, is an innovative approach to
the treatment of Parkinson's disease. ProSavin uses a LentiVector system to
deliver the genes required for dopamine synthesis to neurons in the striatum of
the brain. This compensates for the loss of dopamine associated with the
disease.
The timetable for clinical development of ProSavin was extended last year mainly
due to challenges in the process development for clinical manufacturing. These
challenges have largely been overcome. Currently, additional non-clinical safety
and efficacy studies are being conducted and the manufacturing process for the
clinical material is being finalised.
Preliminary discussions with the regulatory authorities have been encouraging
and the company aims to make a formal submission to the UK Gene Therapy Advisory
Committee for clinical trials before the end of 2005. The planned Phase I/II
trial is to be conducted at the Radcliffe Infirmary in Oxford, UK, in patients
with late stage Parkinson's disease, and is expected to commence in 2006.
RetinoStat(R)
RetinoStat is Oxford BioMedica's novel gene-based treatment for wet age-related
macular degeneration (AMD) and diabetic retinopathy. The product uses a
LentiVector system to deliver genes to the retina that block the formation of
new blood vessels that cause retinopathy. The company is evaluating two versions
of RetinoStat with the anti-angiogenesis genes endostatin and angiostatin,
licensed from EntreMed of Rockville, Maryland, USA.
In the first half of the year, the company and its collaborators from the
Institute of Ophthalmology in London presented encouraging preclinical data from
the RetinoStat programme at the Annual Meeting of the Association for Research
in Vision and Ophthalmology (ARVO) in Fort Lauderdale, Florida, USA. In an
industry standard model of AMD, both versions of RetinoStat were shown to be
safe and well tolerated, both reduced the area of the eye with abnormal blood
vessel growth and both reduced blood vessel leakage in the eye, which leads to
the distortion and loss of central vision in AMD. The two product configurations
demonstrated a statistically significant improvement in all efficacy scores.
In the second half of 2005, Oxford BioMedica expects to complete additional
preclinical efficacy studies, which are being conducted at the Johns Hopkins
Hospital in Baltimore, Maryland, USA, with financial support from the US
charity, Foundation Fighting Blindness. These studies are designed to facilitate
final optimisation of RetinoStat for clinical trials and the results will be
presented at suitable ophthalmology conferences. The company's objective is to
initiate clinical trials with RetinoStat in wet AMD in 2007.
MoNuDin(R)
MoNuDin is based on a novel modified LentiVector system, delivering a vascular
endothelial growth factor (VEGF) gene, which is a neuroprotective for motor
neurons. The product is being developed initially for the treatment of
amyotrophic lateral sclerosis (ALS), the most common form of motor neuron
disease. ALS is an indication where there is an unmet medical need for novel
treatments. Given the size of the patient population, MoNuDin is likely to
qualify for Orphan Drug designation from regulatory authorities.
MoNuDin has previously attracted funding from the US ALS Association. In July
2005, a new grant was received from the UK Motor Neuron Disease (MND)
Association. The initial grant is for £350,000, to fund a key preclinical
efficacy study and support preparations for clinical trials. The company is
targeting the start of clinical development with MoNuDin in 2007. The MND
Association and other US and UK charitable organisations are considering further
sponsorship that could fund initial clinical trials of MoNuDin in ALS patients.
SMN-1G
SMN-1G is Oxford BioMedica's gene-based therapeutic for the treatment of an
inherited motor neuron disease, spinal muscular atrophy (SMA). The product is
designed to restore SMN protein levels by delivering the corrected version of
the SMN1 gene, using a modified LentiVector system to reach motor neurons. As
with ALS, there is a need for effective treatments for SMA, and Oxford BioMedica
expects to have the advantages of Orphan Drug designation for its SMN-1G
programme.
Preclinical efficacy data with SMN-1G were published in the Journal of Clinical
Investigation in December 2004. These studies were supported by FightSMA, a US
charitable organisation, in collaboration with Dr. Arthur Burghes of The Ohio
State University, a leading authority on SMA. In the first half of 2005, the
company started further preclinical studies to optimise the SMN-1G construct and
is planning the clinical development strategy.
Innurex(R)
Innurex is Oxford BioMedica's gene-based product for nerve regeneration for the
treatment of spinal cord and related injuries. Based on the LentiVector
technology, the product carries the gene for a subtype of the retinoic acid
receptor (RAR2) that induces nerve cells to re-grow by a process known as
'sprouting'.
In June 2005, the company presented encouraging preclinical efficacy data at the
Annual Meeting of the American Society of Gene Therapy (ASGT) in St. Louis,
Missouri, USA. The data showed, for the first time, that Innurex is able to
induce nerve repair in spinal cord (corticospinal tract) injuries and restore
both sensory and motor functions in a placebo controlled preclinical model. Very
few products have been able to show nerve repair in models of spinal cord injury
and no products to date have achieved this in the clinical setting.
In this preclinical study of spinal cord injury, there was a statistically
significant improvement in functional ability with Innurex compared to placebo
for most measurements. These data add to previous observations in preclinical
models of avulsion (stretch) injury and suggest that Innurex may be useful in
the clinical treatment of both stretch injury and the technically more
challenging spinal cord damage.
Innurex is being developed in collaboration with King's College London, who
received a grant for the programme in 2004 from the Christopher Reeve Paralysis
Foundation. Further preclinical studies and clinical planning are underway.
Research and Other Programmes
The company has continued to focus research efforts towards its key therapeutic
areas: oncology and neurotherapy. In oncology, the company has a tumour antigen
discovery programme in collaboration with ARIUS Research of Toronto, Canada. At
the end of 2004, the joint programme progressed from the successful
identification of novel cancer targets to focus on a target that is
over-expressed in gastrointestinal and other cancers and could be related to
cancer metastasis. In the first half of 2005, validation of this novel target
continued. Under the agreement, cancer targets and antibodies can be
out-licensed to commercial partners or developed by one or both of the
companies.
Outside of the core therapeutic focus, the company is evaluating a limited
number of product opportunities and novel technology applications. These
programmes are primarily funded through collaborations or grants. One
potentially interesting preclinical product candidate is Requinate(R) for
haemophilia A. This LentiVector-based programme is supported by a grant from the
UK Department of Health. The company is planning a preclinical efficacy study
with Requinate in the next 12 months.
Oxford BioMedica is also evaluating the LentiVector technology as a delivery
mechanism for gene silencing molecules in RNA interference (RNAi). RNAi is a new
technology that allows genes of choice to be switched off. The company's
LentiVector technology is perfectly suited to deliver these molecules. In March
2005, the journal Nature Medicine published a paper on the company's RNAi work,
describing the results from a preclinical study. The LentiVector gene delivery
system was used to deliver a specific RNA molecule that effectively shut down
the gene that causes disease in a model of the neurodegenerative disease
familial ALS. During the first half of 2005, Oxford BioMedica opened
collaboration and licensing discussions with interested parties for access to
the LentiVector technology for RNAi applications.
Technology Licensing
Oxford BioMedica established an active licensing programme for its suite of gene
delivery technologies in early 2004. This initiative secured four licensees
during 2004, including Merck & Co of Whitehouse Station, New Jersey, USA, and
Biogen Idec of Cambridge, Massachusetts, USA.
In the first half of 2005, new licensing agreements were signed with Pfizer of
New York, New York, USA, and another leading biopharmaceutical company, thus
expanding this sustainable revenue stream. The two new licences provide
non-exclusive worldwide rights to the LentiVector technology for research
activities. Under these agreements, Oxford BioMedica receives upfront licence
payments and annual maintenance fees.
In June 2005, another licensee, Viragen of Plantation, Florida, USA, reached a
milestone in its collaborative project with Roslin Institute of Edinburgh,
Scotland, to develop avian transgenic biomanufacturing using the LentiVector
technology. For the first time, Viragen and Roslin produced a potentially
therapeutic protein selectively in the whites of eggs laid by a transgenic hen.
This technology is expected to offer a low cost manufacturing alternative for
the production of many protein drugs, with additional potential advantages in
the quality of the products. The Viragen agreement provides Oxford BioMedica
with upfront and annual licence payments in addition to milestone payments on
the achievement of technical goals and royalties on commercialisation.
Intellectual Property
Oxford BioMedica continues to strengthen its intellectual property estate, which
comprises approximately 80 patent families, covering its product candidates and
suite of technologies. In the first half of 2005, two new patents were filed and
six patents were granted.
The new patents include a key European patent for TroVax. Granted by the
European Patent Office, this patent covers immunotherapy products directed
against 5T4 and includes specific claims to the use of viral delivery systems in
5T4-targeted vaccines. This is one of several granted and pending patents that
protect the company's ownership of the 5T4 tumour antigen.
The patent portfolio that covers the LentiVector technology, which supports the
neurotherapy pipeline and the technology licensing activities, was similarly
strengthened during the period. The company received a Notice of Allowance from
the US Patent Office for a patent containing broad claims covering genetic
modifications that are critical for safe and efficacious application of
lentiviral vectors.
In July 2005, the company announced that the Patent Office of the Peoples'
Republic of China granted two patents that have broad claims covering lentiviral
vectors. Since July, the company has been notified that a further patent was
granted in China. These are the first patents covering the LentiVector
technology in China, the only country in the world with an approved gene therapy
product and a country where opportunities for innovative pharmaceutical
development are predicted to grow substantially over the next decade. Having
these patents in place will help the company to commercialise its products in
China.
Board and Management Changes
In the first half of the year and post period, there were a number of senior
management promotions and appointments. These changes have strengthened the team
and added new expertise. Nick Woolf was promoted to the Board as an executive
director, maintaining his title of senior vice president of corporate strategy.
Dr Stuart Naylor was promoted to senior vice president of research and
development, having previously been vice president of biological systems. In
this role, Stuart has taken certain responsibilities from Professor Susan
Kingsman who has been appointed Chief Scientific Officer.
On 7 September, Dr Mike McDonald joined the company as Chief Medical Officer.
Mike has primary responsibility for the company's clinical development
activities and regulatory affairs. He brings over 20 years of experience in
clinical drug development and regulatory leadership within the biotechnology and
pharmaceutical industry. He joined from Seattle Genetics, and was previously
worldwide vice president for clinical research at Eli Lilly and vice president
of global regulatory affairs at SmithKline Beecham.
Finance
The company's financial position remains good, with significantly lower losses
and a lower cash outflow than the first half of 2004, and cash and short term
investments at 30 June 2005 of £18.6 million.
The company's previous published accounts were produced under UK generally
accepted accounting standards (UK GAAP). The accounts for 2005 are the first to
be produced under International Financial Reporting Standards (IFRS); a
mandatory change for all UK listed companies. The move to IFRS has resulted in
reclassifying expenditure on acquired intellectual property rights as intangible
fixed assets, increasing net assets by £1.6 million at 30 June 2005 (£1.5
million at 30 June 2004 and 31 December 2004). The impact on the reported losses
for the periods reported here is less significant, increasing the net loss for
the six months ended 30 June 2005 by £74,000 and reducing the net losses for the
year ended 31 December 2004 and the six months ended 30 June 2004 by £146,000 in
both cases. The IFRS adjustments are described in note 12 to the financial
statements.
The net loss for the first half of 2005 was £5.0 million (H1 2004: £6.6
million). The 2004 accounts included an exceptional administration charge of
£1.6 million related to the restructuring of the US office.
Revenue for the first half of 2005 of £232,000 (H1 2004: £293,000) arose from
licensing of the LentiVector and other proprietary technologies. The licensing
agreements that were signed in 2004 generate revenue from annual maintenance
fees. Revenue in the first half of 2004 was slightly higher due to the
recognition of initial fees on licences, and because of some non-recurring
items.
Research and development costs were less than the comparative period last year
at £4.8 million (H1 2004: £5.2 million) principally due to a higher level of
expenditure on production and manufacturing in the first half of 2004.
Administration expenses, excluding the exceptional costs in 2004, were unchanged
at £1.5 million (H1 2004: £1.5 million). Grant income in the first half of 2005
was reduced, as three grant programmes have ended. However, new grants from the
UK Department of Health and the MND Association should contribute in the second
half of 2005, allowing increased spending on the Requinate and MoNuDin
programmes.
Interest receivable on bank deposits was £0.5 million (H1 2004: £0.6 million).
This modest reduction reflected the lower average balance on deposit. The loss
before tax for the first half of 2005 narrowed to £5.6 million (H1 2004: £7.1
million) mainly due to lower operating costs in the period and the exceptional
item in the previous year. The tax credit, arising in the UK from R&D credits,
was £0.6 million (H1 2004: £0.5 million).
The format of the balance sheet and cash flow statement has changed slightly
under IFRS but the underlying use of cash resources was reduced in the first
half of 2005. The overall decrease in cash, cash equivalents and short term
investments was £3.8 million (H1 2004: decrease of £5.6 million). The net cash
outflow from operations was £1.2 million less at £4.3 million (H1 2004: outflow
of £5.5 million). There are two parts to this: firstly, the cash outflow from
operations before interest and tax was £0.5 million less at £5.1 million (H1
2004: £5.6 million). Secondly, there was a receipt of £0.7 million in 2005 for
UK R&D tax credit (H1 2004: £nil). The cash outflow for the period was further
reduced by higher proceeds from the issue of shares, which amounted to £0.6
million (H1 2004: £0.2 million). All of the share issues in the first half of
2005 were on the exercise of share options.
Conclusion
The first half of 2005 has again been successful in terms of clinical and
preclinical progress, and business development. Discussions continue with
prospective partners for products within the pipeline including lead products in
the oncology and neurotherapy portfolios. The company's strategy is to secure
development and commercialisation partners for its products following proof of
principle in either clinical or preclinical studies. Signing new collaborations
is a key focus for the company in the next 12 months. The objective for these
collaborations is to maximise shareholder value by balancing near term resource
requirements and long term benefit from product commercialisation.
The company continues to be in a strong position with its innovative pipeline,
proven technology and broad intellectual property. Overall, the outlook for the
company remains positive with significant newsflow anticipated from the oncology
and neurotherapy products. This reflects the potential for significant progress
within the development pipeline and the prospects for new corporate
collaborations and licensing agreements. On behalf of the Board, we thank our
staff, our collaborators and our shareholders for their ongoing support and
commitment.
Dr Peter Johnson Professor Alan Kingsman
Chairman Chief Executive Officer
Consolidated income statement
for the six months ended 30 June 2005
Six months Six months Year
ended ended ended
30 June 30 June 31 December
2005 2004 2004
Notes £'000 £'000 £'000
----------------------- ------ -------- -------- ----------
Continuing operations
Revenue 3 232 293 502
------------------------ ------ -------- -------- ----------
Research and development costs (4,838) (5,233) (9,013)
Administrative expenses (1,505) (3,047) (4,359)
Other operating income: grants 13 229 364
receivable ------ -------- -------- ----------
------------------------
Operating loss (6,098) (7,758) (12,506)
------------------------ ------ -------- -------- ----------
Analysed as:
Operating loss before exceptional item (6,098) (6,180) (10,938)
Exceptional administrative expenses - (1,578) (1,568)
------------------------ ------ -------- -------- ----------
Operating loss (6,098) (7,758) (12,506)
------------------------ ------ -------- -------- ----------
Interest receivable 487 616 1,158
------------------------ ------ -------- -------- ----------
Loss before tax (5,611) (7,142) (11,348)
Taxation 639 536 884
------------------------ ------ -------- -------- ----------
Loss for the period from continuing
operations (4,972) (6,606) (10,464)
---------------------------- -------- -------- ----------
----------
Basic loss and diluted loss per
ordinary share 4 (1.3p) (1.8p) (2.8p)
------------------------ ------ -------- -------- ----------
The results for the periods above are derived entirely from continuing
operations.
There is no difference between the loss on ordinary activities before taxation
and the loss for the periods stated above, and their historical cost
equivalents.
Statement of recognised income and expense
Six months Six months Year
ended ended ended
30 June 30 June 31 December
2005 2004 2004
Notes £'000 £'000 £'000
------------------------ ------ -------- --------- ----------
Loss for the financial period (4,972) (6,606) (10,464)
Employee services credit for share
options 113 45 125
Net exchange adjustments offset in
reserves 11 (2) (55) (47)
------------------------ ------ -------- --------- ----------
Total recognised expense for the (4,861) (6,616) (10,386)
period
------------------------ ------ -------- --------- ----------
Consolidated balance sheet
at 30 June 2005
30 June 30 June 31 December
2005 2004 2004
Notes £'000 £'000 £'000
------------------------ ------ -------- -------- ----------
Assets
Non-current assets
Intangible assets 5 1,641 1,572 1,627
Property, plant and equipment 6 996 1,509 1,237
Financial assets: Investment in joint
venture - 26 -
------------------------ ------ -------- -------- ----------
2,637 3,107 2,864
------------------------ ------ -------- -------- ----------
Current assets
Trade and other receivables 7 1,815 1,880 1,618
Current tax assets 1,700 1,785 1,685
Financial assets: Available for sale
investments 13,174 21,176 17,500
Cash and cash equivalents 8 5,450 5,069 4,917
------------------------ ------ -------- -------- ----------
22,139 29,910 25,720
------------------------ ------ -------- -------- ----------
Liabilities
Current liabilities
Trade and other payables 9 2,171 2,327 1,741
Current tax liabilities 1 49 -
Provisions 10 76 139 73
------------------------ ------ -------- -------- ----------
2,248 2,515 1,814
------------------------ ------ -------- -------- ----------
Net current assets 19,891 27,395 23,906
------------------------ ------ -------- -------- ----------
Non-current liabilities
Provisions 10 396 430 391
------------------------ ------ -------- -------- ----------
Net assets 22,132 30,072 26,379
------------------------ ------ -------- -------- ----------
Shareholders' equity
Ordinary shares 11 3,758 3,716 3,721
Share premium 11 78,886 78,237 78,309
Other reserves 11 86 80 88
Retained losses 11 (60,598) (51,961) (55,739)
------------------------ ------ -------- -------- ----------
Equity shareholders' funds 11 22,132 30,072 26,379
------------------------ ------ -------- -------- ----------
Consolidated cash flow statement
for the six months ended 30 June 2005
Six months Six months Year
ended ended ended
30 June 30 June 31 December
2005 2004 2004
Notes £'000 £'000 £'000
------------------------ ----- --------- --------- ----------
Cash outflows from operating
activities
Cash outflow from operations A (5,149) (5,625) (10,747)
Interest received 245 166 1,096
Tax credit received 650 - 400
Overseas tax paid (26) - -
------------------------ ----- --------- --------- ----------
Net cash outflow from operating (4,280) (5,459) (9,251)
activities
------------------------ ----- --------- --------- ----------
Cash flows from investing
activities
Proceeds from sale of property,
plant and equipment - 105 110
Purchases of property, plant and (118) (228) (316)
equipment
Purchases of intangible assets (14) (165) (229)
Proceeds from sale of available
for sale investments 4,326 1,974 5,650
--------------------------- --------- --------- ----------
Net cash received from investing 4,194 1,686 5,215
activities
------------------------ ----- --------- --------- ----------
Cash flows from financing
activities
Net proceeds from issue of
ordinary share capital 614 160 281
--------------------------- --------- --------- ----------
Effects of exchange rate changes 5 (4) (14)
------------------------ ---- --------- --------- ----------
Net increase/(decrease) in cash
and cash equivalents 533 (3,617) (3,769)
Cash and cash equivalents at 1 4,917 8,686 8,686
January
------------------------ ----- --------- --------- ----------
Cash and cash equivalents at 5,450 5,069 4,917
period end
------------------------ ----- --------- --------- ----------
Notes to the consolidated cash flow statement
for the six months ended 30 June 2005
Six months Six months Year
Note A: ended ended ended
Reconciliation of operating loss to 30 June 30 June 31 December
net cash
outflow from operating activities 2005 2004 2004
£'000 £'000 £'000
------------------------ -------- --------- ----------
Cash generated from continuing operations
Net loss (4,972) (6,606) (10,464)
Adjustments for:
Tax (639) (536) (884)
Depreciation 334 741 1,040
Loss on disposal of property, plant and
equipment - 181 260
Impairment of investment in joint venture - - 26
Impairment of intangibles - (2) 7
Interest income (487) (616) (1,158)
Share options - value of employee
services 113 45 125
Changes in working capital
Decrease/(increase) in trade and other
receivables 65 (194) (394)
Increase in payables 450 812 225
(Decrease)/increase in provisions (23) 569 464
Effects of exchange rate changes 10 (19) 6
---------------------------- -------- --------- ----------
Net cash outflow from continuing
operations (5,149) (5,625) (10,747)
---------------------------- -------- --------- ----------
Notes to accounts
1 Basis of preparation
The financial information for the six months ended 30 June 2005 is unaudited and
has been prepared in accordance with the group's accounting policies, set out
below, that are expected to apply for 2005. The financial information for the
six months ended 30 June 2004 is also unaudited and has been restated in
accordance with the accounting policies set out below. These results have not
been reviewed by the group's Auditors. The financial information relating to the
year ended 31 December 2004 has been extracted from the full report for that
year and has also been restated in accordance with the accounting policies set
out below. This information is currently unaudited. The report of the Auditors
on the 2004 accounts as prepared under UK GAAP was unqualified. The statutory
accounts presented under UK GAAP for the year ended 31 December 2004 were
approved at the company's Annual General Meeting on 11 May 2005. The financial
information in this report does not constitute statutory accounts within the
meaning of Section 240 of the Companies Act 1985.
These interim financial statements have been prepared in accordance with the
accounting policies the company expects to be applicable at 31 December 2005 and
the interpretation of those accounting standards underlying the accounting
policies. As listed companies in a large number of countries are adopting IFRS
for the first time, there is limited established practice upon which to draw in
matters of interpretation and application. Furthermore, it is possible that new
standards and new interpretations may be issued which could affect the group.
These figures may therefore require amendment, to change the basis of accounting
/or presentation of certain financial information, before their inclusion in the
IFRS financial statements for the year ended 31 December 2005, when the group
prepares its first complete set of IFRS statements.
These interim financial statements have been prepared under the historical cost
convention.
The preparation of financial statements requires the use of estimates and
assumptions that affect the reported amounts of assets and liabilities at the
date of the financial statements and the reported amounts of revenues and
expenses during the reporting period. Although the estimates are based on
management's best knowledge of the amount, event or actions, actual results may
differ from those estimates.
Copies of the interim results for the six months ended 30 June 2005 are being
sent to all shareholders. Details can also be found on the company's website at
www.oxfordbiomedica.co.uk. Further copies of the interim results and copies of
the full report and accounts for the year ended 31 December 2004 can be obtained
by writing to the Company Secretary, Oxford BioMedica plc, Medawar Centre,
Oxford Science Park, Oxford, OX4 4GA.
This announcement was approved by the Board of Oxford BioMedica plc on 19
September 2005.
2 Accounting policies
A summary of the more important group accounting policies, which have been
applied consistently to all the financial periods presented, is set out below.
Transitional arrangements
The group is required to establish its IFRS accounting policies for the year
ended 31 December 2005 and apply these retrospectively to determine the IFRS
opening balance sheet at its date of transition, 1 January 2004. IFRS 1
'First-time adoption of International Financial Reporting Standards' sets out
the procedure that the group must follow when it adopts IFRS for the first time
as the basis for preparing its consolidated financial statements. The group has
taken advantage of two optional exemptions under IFRS 1:
1) Share-based payments: The group operates share option schemes, which all of
its employees are entitled to participate in. Under IFRS, income statement
charges are based on the fair value of equity-settled share-based awards at
grant date. The cost is calculated using an option pricing model, and the group
has taken the exemption provided in IFRS 1 which allos the change to be
calculated only in respect of options granted to employees after 7 November 2002
which had not vested by 1 January 2005, amortised over the vesting period of the
options.
2) Business combinations: The group has elected not to apply IFRS 3 'Business
combinations' retrospectively to business combinations which took place prior to
the transition date, namely that the the acquisition in 1996 of 100% of the
issued share capital of Oxford BioMedica (UK) Limited has been accounted for by
the merger accounting method.
An explanation of the impact of how transition from UK GAAP to IFRS has affected
the group's financial position, income statement and cash flows is contained in
note 12.
Basis of consolidation
The consolidated income statement and group balance sheet include the accounts
of the company and its subsidiary undertakings made up to 30 June and 31
December.
Turnover
The group generates turnover as a result of technology licence transactions.
Typically, these transactions are structured such that there is an initial
upfront non-refundable payment on execution of the licence and the potential for
further annual maintenance payments for the term specified in the licence. Where
the initial fee paid is non-refundable and there are no ongoing commitments from
the group, and the licence has no fixed end date, the group recognises the
element received up front, as a payment in consideration of the granting of the
license, on execution of the contract. Maintenance fees within the contracts are
spread over the period to which they relate, usually a year. Amounts recognised
exclude value added tax. Differences between cash received and amounts
recognised are included as deferred revenue where cash received exceeds revenue
recognised and as accrued revenue where revenue has yet to be billed to the
customer.
Segmental reporting
The group has one single business, based upon its proprietary technology,
operated out of two geographical locations - Oxford (UK) which is the principal
operating site, generating all the turnover, and San Diego (USA) which provides
intellectual property management and business development services to the UK
subsidiary.
Financial instruments
The group's financial instruments comprise cash and cash equivalents, together
with available for sale investments, debtors and creditors arising directly from
operations and the onerous lease provision. Cash and cash equivalents comprise
cash in hand and short term deposits which have an original maturity of three
months or less and are readily convertible into known amounts of cash. Bank
deposits with maturity of more than three months are classified as short term
investments, and are carried at their historic purchase price unless there is
objective evidence of impairment. Financial instruments are valued at fair
value, subject to review for impairment at the balance sheet date.
The group does not enter into derivative transactions, and it is the group's
policy not to undertake any trading in financial instruments. The group does not
have any committed borrowing facilities, as its cash, cash equivalents and short
term deposits are sufficient to finance its current operations. Cash balances
are mainly held on short and medium term deposit with quality financial
institutions, in line with the group's policy to minimise the risk of loss. The
main risks associated with the group's financial instruments relate to interest
rate risk and foreign currency risk. The group's policy in relation to interest
rate risk is to monitor short and medium term interest rates and to place cash
on deposit for periods that optimise the amount of interest earned while
maintaining access to sufficient funds to meet day to day cash requirements. In
relation to foreign currency risk, the group's policy is to hold the majority of
its funds in sterling, and no hedging of foreign currency cash outflows is
undertaken. These policies have been applied consistently throughout the periods
reported.
Operating leases
Assets acquired under leases are reviewed to see if they are finance leases or
operating leases, based on the following assumptions:
• If the leases transfer ownership of the assets at the end of the lease
• If they have a bargain purchase option
• If the lease term is for the major part of the economic life of the asset
• If the leased assets are specialised for the lease only
No leases have been classified as finance leases. Costs in respect of operating
leases are charged on a straight line basis over the lease term.
Onerous lease provision
When leasehold properties become redundant or excess space arises in those
properties, the group provides for all costs to the end of the lease or the
anticipated date of surrender of the lease, net of anticipated income. Such
provisions are then discounted.
Property plant and equipment
Property, plant and equipment are carried at their purchase cost, together with
any incidental expenses of acquisition.
Depreciation is calculated so as to write off the cost of property, plant and
equipment less their estimated residual values on a straight line basis over the
expected useful economic lives of the assets concerned. The principal annual
rates used for this purpose are:
%
Short leasehold improvements 20 or the remaining lease term if shorter
Computer equipment 33
Office and laboratory equipment,
fixtures and fittings 20
Intangibles
Intangible fixed assets, relating to intellectual property rights acquired
through licensing or assigning patents and know-how are carried at historic
cost, less accumulated amortisation, where the useful life of the asset is
finite and the asset will probably generate economic benefits exceeding costs.
Where a finite useful life of the acquired intangible asset cannot be
determined, the asset is not subject to amortisation, but is tested at each
balance sheet date for impairment.
Expenditure on product development is capitalised as an intangible asset and
amortised over the expected useful life of the product concerned. Capitalisation
commences from the point at which technical feasibility and commercial viability
of the product can be demonstrated and the group is satisfied that it is
probable that future economic benefits will result from the product once
completed. Capitalisation ceases when the product is ready for launch. No such
costs have been capitalised to date.
Expenditure on research activities and development activities that do not meet
the above criteria, including ongoing costs associated with acquired
intellectual property rights and intellectual property rights generated
internally by the group, is charged to the income statement as incurred.
Government and other grants
Income from government and other grants is recognised over the period necessary
to match them with the related costs which they are intended to compensate, on a
systematic basis. This grant income is included as other operating income within
the income statement, and the related costs are included within research and
development costs and administrative expenses.
Employee benefit costs
The group operates defined contribution pension schemes for its directors and
employees. The assets of the schemes are held in independently administered
funds. The pension cost charge recognised in the period represents amounts
payable by the group to the funds.
Share based payment
Equity settled share-based payments are measured at fair value at the date of
grant and expensed on a straight-line basis over the vesting period of the
award. At each balance sheet date the group revises its estimate of the number
of options that are expected to become exercisable.
The fair value of share options is measured using a Black-Scholes option pricing
model. When share options are exercised the proceeds received are credited to
share capital (nominal value) and share premium.
Other employee benefits
The expected cost of compensated short term absence (e.g. holidays) is
recognised when employees render services that increased their entitlement.
Accrual is made for holidays earned but not taken.
Cash and cash equivalents
Cash and cash equivalents include cash in hand, deposits held on call with banks
and other short term highly liquid investments with original maturities of three
months or less. Bank deposits with original maturities between three months and
twelve months are included in current assets and are classified as available for
sale financial assets.
Currency translation
Monetary assets and liabilities in foreign currencies are translated into
sterling at the rates of exchange ruling at the end of the financial period.
Transactions in foreign currencies are translated into sterling at the rates of
exchange ruling at the date of the transaction. Foreign exchange differences are
taken to the income statement in the year in which they arise.
Assets and liabilities of the company's US subsidiary are translated to sterling
at the period-end exchange rate, whilst its statements of income and cash flows
are translated at monthly average rates. The translation differences that arise
are taken directly to a currency translation account within equity.
Taxation including deferred tax
The charge for current tax is based on the results for the period, adjusted for
items which are non-assessable or disallowed. It is calculated using tax rates
that have been enacted or substantively enacted by the balance sheet date.
Deferred tax is accounted for using the balance sheet liability method in
respect of temporary differences arising from differences between the carrying
amount of assets and liabilities in the financial statements and the
corresponding tax bases used in the computation of taxable profit. In principle,
deferred tax liabilities are recognised for all taxable temporary differences
and deferred tax assets are recognised to the extent that it is probable that
taxable profits will be available against which deductible temporary differences
can be utilised. Such assets and liabilities are not recognised if the temporary
difference arises from goodwill, negative goodwill or from the acquisition of an
asset, which does not affect either taxable or accounting income.
Deferred tax liabilities are recognised for taxable temporary differences
arising on investments in subsidiaries and associates, and interests in joint
ventures, except where the group is able to control the reversal of the
temporary difference and it is probable that the temporary difference will not
reverse in the foreseeable future.
Deferred tax is calculated at the tax rates that are expected to apply to the
period when the asset is realised or the liability is settled. Deferred tax is
charged or credited in the income statement, except when it relates to items
credited or charged directly to equity, in which case the deferred tax is also
dealt with in equity.
3 Segmental analysis
The group's turnover and loss on ordinary activities before taxation are derived
entirely from its principal activity, biotechnology research and development.
The only meaningful business segments comprise the group's UK and US operations.
The majority of the group's activities take place in the UK, with the US
subsidiary providing intellectual property management and business development
support to the UK operation. Prior to the reorganisation in 2004, research and
development activities were also carried out in the USA. Purchases and sales
between subsidiaries are eliminated on consolidation.
The segment results for the periods ended 30 June 2005, 30 June 2004 and 31
December 2004 are as follows:
Primary reporting format - geographic United
Six months ended 30 June 2005 United States of
Kingdom America Total
£'000 £'000 £'000
---------------------- --------- --------- ----------
Continuing operations
Revenue 232 - 232
---------------------- --------- --------- ----------
Segmental operating loss (5,797) (301) (6,098)
Interest receivable/(payable) 503 (16) 487
---------------------- --------- --------- ----------
Loss before tax (5,294) (317) (5,611)
Taxation credit/(payable) 657 (18) 639
---------------------- --------- --------- ----------
Loss attributable to equity shareholders (4,637) (335) (4,972)
---------------------- --------- --------- ----------
United
United States of
Six months ended 30 June 2004 Kingdom America Total
£'000 £'000 £'000
------------------------ --------- --------- ----------
Continuing operations
Revenue 293 - 293
------------------------ --------- --------- ----------
Segmental operating loss (5,512) (2,246) (7,758)
------------------------ --------- --------- ----------
Operating loss before exceptional item (5,492) (688) (6,180)
Exceptional administrative expenses (20) (1,558) (1,578)
------------------------ --------- --------- ----------
Operating loss (5,512) (2,246) (7,758)
------------------------ --------- --------- ----------
Interest receivable 615 1 616
------------------------ --------- --------- ----------
Loss before tax (4,897) (2,245) (7,142)
Taxation credit/(payable) 585 (49) 536
------------------------ --------- --------- ----------
Loss attributable to equity shareholders (4,312) (2,294) (6,606)
------------------------ --------- --------- ----------
United
United States of
Year ended 31 December 2004 Kingdom America Total
£'000 £'000 £'000
------------------------ --------- --------- ----------
Continuing operations
Revenue 502 - 502
------------------------ --------- --------- ----------
Segmental operating loss (9,926) (2,580) (12,506)
------------------------ --------- --------- ----------
Operating loss before exceptional item (9,906) (1,032) (10,938)
Exceptional administrative expenses (20) (1,548) (1,568)
------------------------ --------- --------- ----------
Operating loss (9,926) (2,580) (12,506)
------------------------ --------- --------- ----------
Interest receivable/(payable) 1,169 (11) 1,158
------------------------ --------- --------- ----------
Loss before tax (8,757) (2,591) (11,348)
Taxation credit/(payable) 885 (1) 884
------------------------ --------- --------- ----------
Loss attributable to equity shareholders (7,872) (2,592) (10,464)
------------------------ --------- --------- ----------
Other segmental items included in the income statement are:
United
United States of
Kingdom America Total
£'000 £'000 £'000
----------------------- --------- --------- ----------
Six months ended 30 June 2005
Depreciation 333 1 334
------------------------ --------- --------- ----------
Six months ended 30 June 2004
Depreciation 349 392 741
Loss on disposal of property, plant and
equipment - 181 181
Impairment of intangibles (2) - (2)
------------------------ --------- --------- ----------
Year ended 31 December 2004
Depreciation 693 347 1,040
Loss on disposal of property, plant and
equipment 34 226 260
Impairment of intangibles 7 - 7
Impairment of fixed asset investments 26 - 26
------------------------ --------- --------- ----------
The segment assets and liabilities at 30 June 2005, 30 June 2004 and 31 December
2004, and capital expenditure in the periods then ended, are as follows:
United
United States of
Kingdom America Total
£'000 £'000 £'000
------------------------ --------- --------- ----------
30 June 2005
Total assets 24,350 426 24,776
Total liabilities 2,094 550 2,644
Capital expenditure 93 - 93
Purchase of intangibles 14 - 14
------------------------ --------- --------- ----------
30 June 2004
Total assets 32,196 821 33,017
Total liabilities 2,006 939 2,945
Capital expenditure 229 - 229
Purchase of intangibles 165 - 165
------------------------ --------- --------- ----------
31 December 2004
Total assets 28,247 337 28,584
Total liabilities 1,638 567 2,205
Capital expenditure 334 5 339
Purchase of intangibles 229 - 229
------------------------ --------- --------- ----------
The group's turnover derives from the UK, other EU states and the USA.
Six months Six months Year
ended ended ended
30 June 30 June 31 December
2005 2004 2004
Turnover by destination £'000 £'000 £'000
------------------------ --------- --------- ----------
United Kingdom - 35 35
Rest of Europe 72 - 57
North America 160 258 410
------------------------ --------- --------- ----------
Total turnover 232 293 502
------------------------ --------- --------- ----------
4 Basic loss and diluted loss per ordinary share
The basic loss per share has been calculated by dividing the loss for the period
by the weighted average number of shares of 373,949,311 in issue during the six
months ended 30 June 2005 (six months ended 30 June 2004: 371,046,099; year
ended 31 December 2004: 371,457,455).
The Company had no dilutive potential ordinary 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.
5 Intangibles
Intellectual
property
rights
£'000
---------------------- ---------
Cost
At 1 January 2005 1,991
Additions at cost 14
Disposals (23)
---------------------- ---------
At 30 June 2005 1,982
---------------------- ---------
Impairment
At 1 January 2005 364
Disposals (23)
---------------------- ---------
At 30 June 2005 341
---------------------- ---------
Net book amount at 30 June 2005 1,641
---------------------- ---------
Net book amount at 30 June 2004 1,572
---------------------- ---------
Net book amount at 31 December 2004 1,627
---------------------- ---------
6 Property, plant & equipment
Office
Short equipment,
leasehold fixtures Computer Laboratory
improvements and fittings equipment equipment Total
£'000 £'000 £'000 £'000 £'000
------------------ --------- -------- -------- -------- --------
Cost
At 1 January
2005 2,213 86 308 2,494 5,101
Exchange
differences 24 - - - 24
Additions at
cost 7 1 65 20 93
Disposals - - (10) (28) (38)
------------------ --------- -------- -------- -------- --------
At 30 June 2005 2,244 87 363 2,486 5,180
------------------ --------- -------- -------- -------- --------
Depreciation
At 1 January
2005 1,768 59 267 1,770 3,864
Exchange
differences 24 - - - 24
Charge for the
period 142 8 20 164 334
Disposals - - (10) (28) (38)
------------------ --------- -------- -------- -------- --------
At 30 June 2005 1,934 67 277 1,906 4,184
------------------ --------- -------- -------- -------- --------
Net book amount at
30 June 2005 310 20 86 580 996
------------------ --------- -------- -------- -------- --------
Net book amount
at 30 June 2004 588 33 32 856 1,509
------------------ --------- -------- -------- -------- --------
Net book amount at
31 December 2004 445 27 41 724 1,237
------------------ --------- -------- -------- -------- --------
7 Trade and other receivables
30 June 30 June 31 December
2005 2004 2004
£'000 £'000 £'000
---------------------------- -------- --------- ----------
Amounts falling due after more than one year
Other debtors - rent deposit 229 259 214
---------------------------- -------- --------- ----------
Amounts falling due within one year
Trade debtors 45 195 162
Other debtors 845 992 619
Other tax receivable 318 89 124
Prepayments and accrued income 378 345 499
---------------------------- -------- --------- ----------
1,586 1,621 1,404
---------------------------- -------- --------- ----------
Total trade and other receivables 1,815 1,880 1,618
---------------------------- -------- --------- ----------
8 Cash and cash equivalents
30 June 30 June 31 December
2005 2004 2004
£'000 £'000 £'000
--------------------------- -------- --------- ----------
Cash at bank and in hand 236 432 40
Short term bank deposits 5,214 4,637 4,877
---------------------------- -------- --------- ----------
Total cash and cash equivalents 5,450 5,069 4,917
---------------------------- -------- --------- ----------
The effective interest rate on short-term deposits was 4.60% (30 June 2004
4.37%, 31 December 2004 4.48%) and these deposits have an average maturity of 56
days.
9 Trade and other payables - current
30 June 30 June 31 December
2005 2004 2004
£'000 £'000 £'000
---------------------------- -------- --------- ----------
Trade payables 465 571 351
Other taxation and social security payable 150 96 219
Accruals and deferred income 1,556 1,660 1,171
---------------------------- -------- --------- ----------
Total payables 2,171 2,327 1,741
---------------------------- -------- --------- ----------
10 Provisions - onerous lease provision
30 June 30 June 31 December
2005 2004 2004
£'000 £'000 £'000
---------------------------- -------- --------- ----------
At 1 January 464 - -
Charged to the income statement - 569 568
Utilised in the period (40) - (101)
Amortisation of discount 10 - 13
Adjustment due to change of discount rate 7 - 10
Exchange difference 31 - (26)
---------------------------- -------- --------- ----------
At 30 June/31 December 472 569 464
---------------------------- -------- --------- ----------
30 June 30 June 31 December
2005 2004 2004
£'000 £'000 £'000
---------------------------- -------- --------- ----------
Current 76 139 73
Non-current 396 430 391
---------------------------- -------- --------- ----------
Total provisions 472 569 464
---------------------------- -------- --------- ----------
The onerous lease provision relates to the estimated rental shortfall in respect
of the property in San Diego, USA, discounted at 4.10% per annum, and will be
utilised over the term of the lease which is due to expire in 2012.
11 Statement of changes in shareholders' equity
Share Share Translation Merger Retained
capital premium reserve reserve losses Total
£'000 £'000 £'000 £'000 £'000 £'000
-------------------- ------ ------- -------- ------ ------- ------
At 1 January 2004 3,703 78,045 (576) 711 (45,400) 36,483
Exchange adjustments - - (55) - - (55)
Loss for the 6
months - - - - (6,606) (6,606)
ended 30 June 2004
New shares issued
excluding share
options 3 53 - - - 56
Costs of share - (21) - - - (21)
issues
Share options -
proceeds from
shares
issued 10 160 - - - 170
Share options -
value - - - - 45 45
of employee services
-------------------- ------ ------- -------- ------ ------- ------
At 30 June 2004 3,716 78,237 (631) 711 (51,961) 30,072
-------------------- ------ ------- -------- ------ ------- ------
Exchange adjustments - - 8 - - 8
Loss for the 6
months ended
31 December 2004 - - - - (3,858) (3,858)
New shares issued
excluding share
options 4 51 - - - 55
Costs of share - 2 - - - 2
issues
Share options -
proceeds
from shares issued 1 19 - - - 20
Share options -
value - - - - 80 80
of employee services
-------------------- ------ ------- -------- ------ ------- ------
At 31 December 2004 3,721 78,309 (623) 711 (55,739) 26,379
-------------------- ------ ------- -------- ------ ------- ------
Exchange adjustments - - (2) - - (2)
Loss for the 6
months - - - - (4,972) (4,972)
ended 30 June 2005
New shares issued - - - - - -
excluding share
options
Costs of share - - - - - -
issues
Share options -
proceeds
from shares issued 37 577 - - - 614
Share options -
value - - - - 113 113
of employee services
-------------------- ------ ------- -------- ------ ------- ------
At 30 June 2005 3,758 78,886 (625) 711 (60,598) 22,132
-------------------- ------ ------- -------- ------ ------- ------
12 Reconciliation of net assets and loss under UK GAAP to IFRS
Oxford BioMedica plc reported under UK GAAP in its previously published
financial statements for the six months ended 30 June 2004 and the year ended 31
December 2004. The analyses below show reconciliations of the net assets under
UK GAAP to IFRS at the transition date, which was 1 January 2004, and of the
losses and net assets as reported under UK GAAP as at 30 June 2004 and 31
December 2004 to the revised losses under IFRS as reported in these interim
financial statements.
Effect of
Previous transition
Reconciliation of equity at 1 January GAAP to IFRS IFRS
2004
(Date of transition to IFRS) Notes £'000 £'000 £'000
------------------------ ------ -------- -------- --------
Intangible assets (a) 135 1,270 1,405
Property, plant and equipment 2,331 - 2,331
Financial assets: Investment in joint 26 - 26
venture ------ -------- -------- --------
------------------------
Total non-current assets 2,492 1,270 3,762
------------------------ ------ -------- -------- --------
Trade and other receivables 1,186 - 1,186
Current tax assets 1,200 - 1,200
Financial assets: available for sale
investments 23,150 - 23,150
Cash and cash equivalents 8,686 - 8,686
------------------------ ------ -------- -------- --------
Total current assets 34,222 - 34,222
------------------------ ------ -------- -------- --------
Total assets 36,714 1,270 37,984
Trade and other payables (1,501) - (1,501)
------------------------ ------ -------- -------- --------
Total assets less total liabilities 35,213 1,270 36,483
------------------------ ------ -------- -------- --------
Ordinary shares 3,703 - 3,703
Share premium 78,045 - 78,045
Other reserves 135 - 135
Retained losses (46,670) 1,270 (45,400)
------------------------ ------ -------- -------- --------
Total equity 35,213 1,270 36,483
------------------------ ------ -------- -------- --------
Six months Year
ended ended
30 June 31 December
2004 2004
Reconciliation of net loss Notes £'000 £'000
------------------------ ------ -------- ---------
Net loss for the period reported under UK (6,752) (10,610)
GAAP
Intangibles (a) 191 271
Share based payment (b) (45) (125)
------------------------ ------ -------- ---------
Net loss for the period reported under IFRS (6,606) (10,464)
------------------------ ------ -------- ---------
Effect of
Previous transition
Reconciliation of loss GAAP to IFRS IFRS
for the six months ended 30 June 2004 Notes £'000 £'000 £'000
------------------------ ------ -------- -------- --------
Revenue 293 - 293
------------------------ ------ -------- -------- --------
Research and development costs (a,b) (5,392) 159 (5,233)
Administrative expenses (b) (3,034) (13) (3,047)
Other operating income: grants 229 - 229
receivable ------ -------- -------- --------
------------------------
Operating loss (7,904) 146 (7,758)
Interest receivable 616 - 616
Taxation 536 - 536
------------------------ ------ -------- -------- --------
Net loss for the period (6,752) 146 (6,606)
------------------------ ------ -------- -------- --------
Effect of
Previous transition
Reconciliation of equity at 30 June GAAP to IFRS IFRS
2004
Notes £'000 £'000 £'000
------------------------ ------ -------- -------- --------
Intangible assets (a) 111 1,461 1,572
Property, plant and equipment 1,509 - 1,509
Financial assets: Investment in joint 26 - 26
venture ------ -------- -------- --------
------------------------
Total non-current assets 1,646 1,461 3,107
------------------------ ------ -------- -------- --------
Trade and other receivables 1,880 - 1,880
Current tax assets 1,785 - 1,785
Financial assets: available for sale
investments 21,176 - 21,176
Cash and cash equivalents 5,069 - 5,069
------------------------ ------ -------- -------- --------
Total current assets 29,910 - 29,910
------------------------ ------ -------- -------- --------
Total assets 31,556 1,461 33,017
------------------------ ------ -------- -------- --------
Trade and other payables (2,327) - (2,327)
Current tax liabilities (49) - (49)
Provisions (569) - (569)
------------------------ ------ -------- -------- --------
Total liabilities (2,945) - (2,945)
------------------------ ------ -------- -------- --------
Total assets less total liabilities 28,611 1,461 30,072
------------------------ ------ -------- -------- --------
Ordinary shares 3,716 - 3,716
Share premium 78,237 - 78,237
Other reserves 80 - 80
Retained losses (53,422) 1,461 (51,961)
------------------------ ------ -------- -------- --------
Total equity 28,611 1,461 30,072
------------------------ ------ -------- -------- --------
Effect of
Previous transition
Reconciliation of loss GAAP to IFRS IFRS
for the year ended 31 December 2004 Notes £'000 £'000 £'000
------------------------ ------ -------- -------- --------
Revenue 502 - 502
------------------------ ------ -------- -------- --------
Research and development costs (a,b) (9,190) 177 (9,013)
Administrative expenses (b) (4,328) (31) (4,359)
Other operating income: grants 364 - 364
receivable ------ -------- -------- --------
------------------------
Operating loss (12,652) 146 (12,506)
Interest receivable 1,158 - 1,158
Taxation 884 - 884
------------------------ ------ -------- -------- --------
Net loss for the year (10,610) 146 (10,464)
------------------------ ------ -------- -------- --------
Effect of
Previous transition
GAAP to IFRS IFRS
Reconciliation of equity at 31 Notes £'000 £'000 £'000
December 2004 ------ -------- -------- --------
------------------------
Intangible assets (a) 86 1,541 1,627
Property, plant and equipment 1,237 - 1,237
------------------------ ------ -------- -------- --------
Total non-current assets 1,323 1,541 2,864
------------------------ ------ -------- -------- --------
Trade and other receivables 1,618 - 1,618
Current tax assets 1,685 - 1,685
Financial assets: available for sale
investments 17,500 - 17,500
Cash and cash equivalents 4,917 - 4,917
------------------------ ------ -------- -------- --------
Total current assets 25,720 - 25,720
------------------------ ------ -------- -------- --------
Total assets 27,043 1,541 28,584
------------------------ ------ -------- -------- --------
Trade and other payables (1,741) - (1,741)
Provisions (464) - (464)
------------------------ ------ -------- -------- --------
Total liabilities (2,205) - (2,205)
------------------------ ------ -------- -------- --------
Total assets less total liabilities 24,838 1,541 26,379
------------------------ ------ -------- -------- --------
Ordinary shares 3,721 - 3,721
Share premium 78,309 - 78,309
Other reserves 88 - 88
Retained losses (57,280) 1,541 (55,739)
------------------------ ------ -------- -------- --------
Total equity 24,838 1,541 26,379
------------------------ ------ -------- -------- --------
Effect of
Previous transition
Reconciliation of loss GAAP to IFRS IFRS
for the six months ended 30 June 2005 Notes £'000 £'000 £'000
------------------------ ------ -------- -------- --------
Operating loss (a,b) (6,024) (74) (6,098)
Interest receivable 487 - 487
Taxation 639 - 639
------------------------ ------ -------- -------- --------
Net loss for the period (4,898) (74) (4,972)
------------------------ ------ -------- -------- --------
Explanation of reconciling items between UK GAAP and IFRS
(a) Intangibles
Under IFRS acquired intellectual property rights are capitalised as intangibles
and either amortised or reviewed for impairment at each balance sheet date.
Under UK GAAP intellectual property rights were written off in the accounting
period in which they were incurred, with the exception of certain intellectual
property rights acquired by the group at inception, which were capitalised as
intangibles and amortised over ten years. As a result, at 1 January 2004
expenditure of £1,270,000 that had previously been charged to the profit and
loss account was reclassified as intangible fixed assets, and amortisation
totalling £357,000 that had previously been charged to the profit and loss
account was replaced by impairment losses of £357,000. In 2004 a further
£229,000 that had been charged to the profit and loss account under UK GAAP was
reclassified as intangible fixed assets, and an amortisation charge of £49,000
was replaced by further impairment losses of £7,000.
(b) Share based payment
Under IFRS 2 a charge is required for all share-based payments including share
options. The charge in the income statement is based on the fair value of the
options at the grant date. Under UK GAAP there was no charge to the profit and
loss account, as there was no difference between the exercise price and the
market price at the date of issue. The company has taken advantage of an
exemption in IFRS 1, and has not included charges for share options issued
before 7 November 2002 or options which had already vested at 1 January 2005.
The IFRS 2 charges were: 30 June 2005 £113,000; 31 December 2004 £125,000; 30
June 2004 £45,000. There is no impact on net assets.
Explanation of material adjustments to the cash flow statements
Interest received of £245,000 (31 December 2004 £1,096,000; 30 June 2004
£166,000) and net income tax received of £624,000 (31 December 2004 £400,000; 30
June 2004 £Nil) are classified as part of operating cash flows under IFRS, but
were included in separate categories in the UK GAAP cash flow statement.
Expenditure on acquired intellectual property rights of £14,000 (year ended 31
December 2004 £229,000, six months ended 30 June 2004 £165,000) are classified
as part of cash flows from investing activities under IFRS, but had previously
been included in the net cash outflow from operating activities.
Cash and cash equivalents include short term deposits of £5,214,000 (31 December
2004 £4,877,000; 30 June 2004 £4,637,000) under IFRS. Under UK GAAP these
amounts were included in the management of liquid resources category. There are
no other material differences between the cash flow statement presented under
IRFS and the cash flow statement presented under UK GAAP.
This information is provided by RNS
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Friday, 31st May 2024
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