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Oxford Biomedica PLC
27 August 2015
OXFORD BIOMEDICA PLC
INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2015
Oxford, UK - 27 August 2015: Oxford BioMedica plc (LSE: OXB),
("OXB" or "the Group") a leading gene and cell therapy group, today
announces interim results for the six months ended 30 June
2015.
HIGHLIGHTS
STRATEGY:
-- Good progress continued in executing the Group's strategy of
being a world-leading independent gene and cell therapy
business:
- Innovative portfolio of gene and cell therapy product candidates
- Partner of choice for lentiviral vector process development, manufacture and IP
- Revenue from manufacturing and process development helping to offset cash burn
OPERATIONAL:
-- Developments made across wholly-owned lentiviral vector pipeline:
- Encouraging results from RetinoStat(R) Phase I study in wet AMD
- Promising three year follow-up data from ProSavin(R) Phase
I/II study. Phase I/II clinical trial utilising OXB-102, a more
potent version, on schedule to begin in 2016
- EncorStat(R) being prepared for Phase I/II study at Moorfields Eye Hospital, London
- Exciting CAR-T 5T4 research programme, combining
LentiVector(R) and 5T4 technology, progressing well
-- Novartis contract delivery on track:
- Multiple CTL019 lentiviral vector batches manufactured for
Novartis during first half of the year
- Novartis-led global CTL019 trial ongoing, using OXB-manufactured vector
- Process development activities well underway and on target
-- Manufacturing capacity expansion:
- Harrow House first phase expansion due to complete by end of the year
- New Yarnton facility on track and nearing completion
- Windrush Court North Wing refurbishment is on track with new
laboratory construction programme in progress
-- Bolstered Board:
- Daniel Soland appointed Non-Executive Director of the Board
FINANCIAL:
-- Revenue of GBP4.4 million (H1 2014: GBP4.7 million) due in large part to Novartis contract
-- Other operating income of GBP1.4 million (H1 2014: GBP0.4 million)
-- Research & Development costs of GBP9.2 million (H1 2014: GBP6.9 million)
-- Net loss of GBP6.1 million (H1 2014: GBP4.8 million)
-- Capital expenditure GBP4.6 million (H1 2014: GBP0.1 million)
-- Cash of GBP15.1 million (31 December 2014: GBP14.2 million)
-- $50 million (GBP32.6 million) loan facility secured to
finance capacity expansion, pipeline advancements and product
acquisitions
John Dawson, Chief Executive Officer of Oxford BioMedica, said:
"I am very pleased by the progress we have made over the past six
months. We have seen encouraging data from both the RetinoStat(R)
Phase I study and the long-term follow-up of ProSavin(R) patients
which give us further confidence that our lentiviral vector
platform can deliver meaningful and sustained long-term benefit to
patients. We have also made a good start in delivering the Novartis
contract and the Group's sector-leading expertise in integrated
gene and cell therapy is clearly in demand. We are well placed to
benefit from additional manufacturing contracts and from the
opportunities our business model now presents us."
-Ends-
An analyst briefing will be held at 09:30am BST on Thursday, 27
August 2015 at the offices of Consilium Strategic Communications,
41 Lothbury, London, EC2V 8AE. There will be a simultaneous live
conference call and the presentation will be available on the
Group's website at www.oxfordbiomedica.co.uk.
Please visit the website approximately five minutes before the
conference call, at 09:25 am BST, to download the presentation
slides. Conference call details:
Participant dial-in: +44 (0) 1452 555566
Conference ID: 17279692
An audio replay file will be made available by the end of the
day via the Group's website on the "Media/Download centre/Webcasts
and audio" section. Alternatively, you may listen to the replay by
dialling the following number:
Dial-in for replay (available until 24-09-2015): +44
(0)1452550000
Conference ID: 17279692
For further information, please contact:
Oxford BioMedica plc: Tel: +44 (0)1865
John Dawson, Chief Executive Officer 783 000
Tim Watts, Chief Financial Officer
Media/Financial Enquiries: Tel: +44 (0)20
Mary-Jane Elliott/Matthew Neal/Chris Welsh/Laura 3709 5700
Thornton OxfordBioMedica@Consilium-comms.com
Consilium Strategic Communications
Disclaimer
This press release contains "forward-looking statements",
including statements about the discovery, development and
commercialisation of products. Various risks may cause Oxford
BioMedica's actual results to differ materially from those
expressed or implied by the forward-looking statements, including
adverse results in clinical development programmes; failure to
obtain patent protection for inventions; commercial limitations
imposed by patents owned or controlled by third parties; dependence
upon strategic alliance partners to develop and commercialise
products and services; difficulties or delays in obtaining
regulatory approvals and services resulting from development
efforts; the requirement for substantial funding to conduct
research and development and to expand commercialisation
activities; and product initiatives by competitors. As a result of
these factors, prospective investors are cautioned not to rely on
any forward-looking statements. Oxford BioMedica disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Notes to editors
About Oxford BioMedica
Oxford BioMedica plc (LSE: OXB) is a leading gene and cell
therapy group with an unrivalled portfolio of gene therapy products
in development and a platform of exclusive and pioneering
technologies with which it designs, develops and manufactures
unique gene-based medicines for some of world's largest
pharmaceutical companies. Leveraging its proprietary lentiviral
vector IP and gene delivery system technology platform and unique
tumour antigen (5T4), Oxford BioMedica is advancing its proprietary
pipeline of gene therapy products addressing diseases for which
there are currently no treatments or that are inadequately treated
today, including ocular, oncology and central nervous system
disorders. OXB Solutions, the Group's industry-leading
manufacturing and development business, provides services to
collaborators and partners working in gene and cell therapy,
including Novartis and Immune Design. In addition, the Group has
licenced products and IP to Sanofi, Pfizer, MolMed, Sigma-Aldrich,
Biogen, Emergent BioSolutions and ImaginAb. Further information is
available at www.oxfordbiomedica.co.uk and
www.oxbsolutions.co.uk.
Overview
During the first six months of 2015 Oxford BioMedica continued
to make good progress in executing the Group's strategy of building
a world-leading independent gene and cell therapy business with
high value innovation. The Group has unsurpassed expertise in
lentiviral vectors and, as well as advancing its wholly-owned
pipeline, has become the partner of choice for process development,
manufacture and IP.
Oxford BioMedica's innovative proprietary pipeline has
progressed well during the period with encouraging data generated
from RetinoStat(R) and ProSavin(R) clinical studies and the
progression of pre-clinical candidates EncorStat(R) and OXB-102
towards the start of Phase I/II clinical studies in 2016.
Lentiviral vectors have several advantages over other vector
delivery systems and Oxford BioMedica's dominant position in this
arena spans both in vivo and ex vivo therapies including its own
high value portfolio and those of other world-class pharmaceutical
companies.
The Group's existing manufacturing facility (Harrow House) has,
for the first time, operated at full capacity over a six month
period with the revenue generated helping to offset cash burn. The
Group has started a programme of capacity expansion which, in
addition to allowing the Group to meet its commitments to Novartis
and internal Oxford BioMedica needs, will also enable the Group to
offer services and expertise to new collaborators and partners.
Operational review
PRODUCT DEVELOPMENT
Proprietary pipeline of wholly-owned clinical and near-clinical
stage programmes.
RetinoStat(R)
The results of the RetinoStat(R) Phase I study, a product
candidate which uses the Group's lentiviral vector technology, were
announced in May 2015. The study, which was conducted with patients
suffering from severe late-stage wet age-related macular
degeneration (Wet AMD), met the primary endpoints of safety and
tolerability. Patients also showed signs of clinical benefit with
visual acuity stabilisation and a reduction in vascular leakage
consistent with the mechanism of action of endostatin and
angiostatin. The data from the Phase I study will be published in a
peer-reviewed journal and the Group is currently evaluating the
optimal development pathway for this candidate.
EncorStat(R)
The Group is working towards the start of a Phase I/II study for
EncorStat(R) for the prevention of corneal graft rejection. The
clinical Phase I/II study, partially funded by a GBP1.8 million
Innovate UK grant, will be conducted at Moorfields Eye Hospital and
is expected to start in the second half of 2016.
OXB-102 / ProSavin(R)
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In May 2015, Professor Stéphane Palfi MD, PhD presented at the
American Association of Neurological Surgeons (AANS) conference the
results of the long term (three year) follow up of the fifteen
Parkinson's disease patients in the Phase I/II study of ProSavin(R)
. A significant improvement in mean unified Parkinson's disease
rating scale (UPDRS) part III motor scores in the off medication
compared to baseline in all patients had been observed at six and
twelve months. The follow up to date has shown that this
improvement has been sustained in the majority of patients for up
to three years in this progressively degenerative disease.
The data supports the continued development of OXB-102, an
enhanced construct of ProSavin(R) , which pre-clinical studies have
shown to be five to ten times more potent than ProSavin(R) .
Clinical trial material has been manufactured and the clinical
Phase I/II study is planned to start in 2016, partially funded by a
GBP2.2 million grant from Innovate UK.
Trovax(R)
One Phase I/II and two Phase II investigator-sponsored studies
to assess the safety and immunological activity of Trovax(R) in
patients with inoperable metastatic colorectal cancer, mesothelioma
and ovarian cancer, are ongoing with a biomarker being used to
select patients. Encouraging interim data from the colorectal
cancer study was presented at The Cancer Vaccine Institute's Second
International Symposium on Immunotherapy in May 2015. This study
and the mesothelioma study are both expected to report towards the
end of 2015 and in 2016. In addition, a Phase I study investigating
Trovax(R) in early-stage prostate cancer patients has recently
opened (sponsored by the University of Oxford and funded from the
European Union Seventh Framework Programme (FP7/2007-2013) under
grant agreement no 602705).
Research/pre-clinical stage programmes
Glaucoma-GT
The glaucoma pre-clinical development with the Mayo Clinic to
demonstrate proof of concept by lowering of intraocular pressure is
likely to complete in 2016.
MoNuDin(R)
MoNuDin(R) continues to progress well in pre-clinical
development with results expected by the end of 2016.
CAR-T 5T4
The Group is researching a potential product which combines both
its lentiviral vector and 5T4 technology platforms. The product is
based on a gene modified autologous T cell which is engineered
using a lentiviral vector to express an antibody against 5T4. The
T-cell would then be infused into the patient where it would
recognise the 5T4 tumour antigen and trigger the normal T cell
killing mechanisms which destroy the cancer cell. This new product
concept is currently in research and is expected to complete this
stage during 2016.
Partnered programmes
SAR 422459 and SAR 421869
Sanofi licensed SAR 422459 and SAR 421869 from Oxford BioMedica
in 2014 for the treatment of orphan ophthalmology diseases
Stargardt disease and Usher syndrome respectively. Sanofi is now
fully responsible for the development of these products and has
taken over management of the current Phase I/II clinical trials.
The Group is eligible to receive development and commercialisation
milestone payments and royalties on any future sales.
Anti-5T4 antibody licence
Due to a reassessment of its portfolio prioritisation Pfizer has
recently terminated recruitment to their Phase I study
(PF-06263507) incorporating an anti-5T4 antibody licensed from
Oxford BioMedica. This decision is not related to data emerging
from the current study nor to any safety concerns and the existing
5T4 license agreement with Pfizer remains unaffected.
PROCESS DEVELOPMENT AND MANUFACTURING
Throughout the first six months of 2015 Oxford BioMedica's
existing manufacturing facility operated at full capacity, apart
from brief periods for routine and planned maintenance and
cleaning. The Group has manufactured a batch of OXB-102, for the
Phase I/II Parkinson's disease study planned to start in 2016, and
also several batches of CTL019 for Novartis. CTL019 is Novartis's
investigational chimeric antigen receptor (CAR) T cell therapy for
the treatment of paediatric and adult patients with
relapsed/refractory acute lymphoblastic leukaemia.
Capacity expansion
To be able to meet its obligations under the Novartis contract,
the Group is in the process of expanding its existing Harrow House
manufacturing facility as well as opening a new manufacturing
facility in Yarnton, also in Oxford, UK. These developments will
ultimately increase the physical space for manufacturing by around
five-fold. Work has also started on expanding and upgrading the
laboratories at Windrush Court so that the Group can complete its
move out of the Medawar Centre by March 2016. The total spend on
these expansion plans is expected to be in the region of GBP20
million with the project scheduled to complete in 2016. The new
facility at Yarnton is expected to be the first of these to come on
line, probably in the fourth quarter of 2015.
The Group has also been hiring new employees to meet the demands
of the Novartis contract. The total number of employees at 30 June
2015 was 192, up from 134 at the end of 2014 and 107 at 30 June
2014. The bulk of the new employees are either directly or
indirectly involved with the production and quality control
processes, although there have also been increases in headcount
working on process and other technical development projects.
The Group is actively seeking further revenue-generating
opportunities from licensing its technology and signing further
process development and manufacturing contracts with third parties.
As more gene and cell therapy products progress into clinical
development, there is increasing interest from other companies for
Oxford BioMedica's process development and manufacturing
capabilities.
LOAN FACILITY
In May 2015 the Group announced that it had secured a $50
million (GBP32.6 million) loan facility from Oberland Capital
Healthcare (Oberland). The funds are being used to invest in the
Group's capacity expansion programme. To date $25 million (GBP16.3
million) of the loan has been drawn down, with the remaining funds
available in minimum tranches of $5 million at the Group's option
prior to 31 December 2016. The UK Government's Advanced
Manufacturing Supply Chain Initiative (AMSCI) GBP5.3 million loan
facility is now terminated and the GBP3 million drawn down has been
repaid.
BOARD UPDATE
On 7 May 2015, Daniel Soland was appointed as a Non-Executive
Director of the Group. Mr Soland has an outstanding track-record of
leadership and innovation and a strong knowledge of the US
environment. His extensive experience of clinical development,
launching of new drugs and manufacturing is highly relevant as
Oxford BioMedica continues the expansion of its already successful
OXB Solutions business. Mr. Soland worked at ViroPharma from 2006
to 2014. He was Senior Vice President and Chief Operating Officer
when it was acquired by Shire in 2014. During his time at
ViroPharma, Mr. Soland managed the commercial, manufacturing and
quality organisations, helped build the company's commercial
infrastructure in the United States, Europe, and Canada and led the
launch of Cinryze(R) , one of the most successful ultra-orphan
drugs in the United States. Previously, he was President at Chiron
Vaccines growing the business to more than $1 billion in sales, and
President and Chief Executive Officer of Epignesis Pharmaceuticals.
He currently serves on the board of directors of Tarsa
Therapeutics, DBV Technologies SA., and ACADIA Pharmaceuticals.
Financial Review
The first six months of 2015 have been notable for a substantial
step up in the Group's activities on several fronts and the impact
of these can be clearly seen in the financial statements. Income
from manufacturing and process development activities for Novartis
increased compared with the comparable period in 2014 although
costs have also risen as the Group has invested in both staff and
facilities to service the increased demand.
The number of employees has increased from 134 at 31 December
2014 (107 at June 2014) to 192 at 30 June 2015. The majority of the
new employees have been recruited to support the expanding
production and process development activities, although there has
also been some increase in supporting staff.
Having secured the Novartis contract in October 2014 Oxford
BioMedica acquired Windrush Court, Oxford, as our new office and
laboratory complex, which requires a complete refurbishment and
re-fit of the laboratories. The Group expects to vacate its
long-standing facility at the Medawar Centre at the end of the
first quarter of 2016, at which point duplication in facility costs
will cease.
As well as investing in the Windrush Court laboratories, the
Group is also incurring substantial capital expenditure on
expanding its manufacturing facilities at Harrow House, and
bringing on line a new facility at Yarnton. The Group expects to
incur expenditure in the region of GBP20 million during 2015 and
2016 on these projects although the later stages of the phased
Harrow House expansion project have yet to be put out to tender and
so resultant costs are not certain.
In May 2015 the Group announced a $50 million loan facility
provided by Oberland of which $25 million has already been drawn
down. Part of the proceeds were used to repay the loan facility
provided under the UK Government's Advanced Manufacturing Supply
Chain Initiative (AMSCI).
The net loss for the six months ended 30 June 2015 was GBP6.1
million (H1 2014: GBP4.8 million), with a cash outflow from
operating activities and capital expenditure of GBP13.9 million (H1
2014: GBP5.0 million). At 30 June 2015, the Group had cash, cash
equivalents and financial assets available for sale totalling
GBP15.1 million.
Income statement
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Total income - i.e. the aggregate of Revenue and Other Operating
Income - was GBP5.8 million in H1 2015 compared with GBP5.1 million
in H1 2014, an increase of 14%. Note that process development
income in 2015 arising from the October 2014 Novartis collaboration
is included in Other Operating Income whereas process development
income in 2014, which arose under the May 2013 contract, is
included in Revenue. This difference in accounting treatment is due
to the differing nature of the two contracts with process
development income under the 2014 contract essentially being the
reimbursement of R&D costs incurred in developing IP which
Oxford BioMedica will own.
Over 85 per cent of the Revenue of GBP4.4 million in the first
half of 2015 was derived from the Novartis manufacturing contract
announced in October 2014, with the balance arising from ongoing
work for Sanofi and small, long-standing intellectual property
licence agreements. In the comparable period in 2014 Novartis
manufacturing and process development activities represented
approximately three-quarters of the GBP4.7 million revenues, with
revenues from Sanofi adding around one-fifth.
It is worth noting that the Harrow House "GMP1" manufacturing
facility has operated at full capacity for the whole period, except
for a shut-down period for routine maintenance and cleaning at the
start of the year. Manufacturing revenues from Novartis were nearly
50% higher in the first six months of 2015 than in the same period
of 2014 despite the Group also manufacturing a batch of OXB-102 for
the Phase I clinical trial during the six-month period.
Other Operating Income in 2015 of GBP1.4 million includes income
from both Novartis process development work and grants receivable
whereas in 2014 (GBP0.4 million) only grants were included, with
process development included in Revenue. Process development in
2015 was about 30 per cent lower than in 2014 whereas grants
receivable are more than 80 per cent higher in 2015 than in 2014.
The increase in grants receivable was caused by the step up in
activities related to EncorStat(R) and OXB-102, which both receive
grants from Innovate UK, and also the process development
activities covered by the grant from the AMSCI. Grants from these
bodies typically cover 60 per cent of the actual costs
incurred.
The increase in cost of sales to GBP2.4 million from GBP1.9
million in 2014 is due entirely to the increased manufacturing
activity. Cost of sales includes the costs of raw materials, the
direct and indirect labour associated with manufacture, quality
control, analytical testing, facility costs and overheads.
R&D costs rose from GBP6.9 million in the first half of 2014
to GBP9.2 million in the first half of 2015, an increase of GBP2.3
million. Of the GBP9.2 million, there are GBP1.7 million
production-related costs (2014: GBP1.1 million) which are not
charged as cost of sales, although approximately GBP0.4 million of
this cost has been incurred by the need to recruit and train
production-related staff for the new Yarnton facility which should
start production in the fourth quarter of 2015. Product and
technical development activities, including laboratory support and
facility costs, amount to GBP5.2 million (2014: GBP3.8 million) of
which around GBP2.0 million is covered by revenues from third
parties and grants. The support and facility costs are somewhat
duplicated in 2015 due to the acquisition of Windrush Court whilst
still retaining the Medawar Centre facility on the Oxford Science
Park which the Group plans to vacate next year when the significant
laboratory upgrade at Windrush Court is complete. The remaining
GBP2.3 million (2014: GBP2.6 million) within R&D includes
management costs relating to R&D and business development
activities and also costs incurred in managing the Group's
intellectual property estate.
Administrative expenses were GBP2.5 million (H1 2014: GBP1.8
million). Approximately half of these costs are payroll-related
costs which have risen by around GBP0.4 million due to the need to
increase support and management functions to support the business's
expansion. The rest of the costs include items such as insurance,
IT, and the costs of being a publicly listed company.
Finance costs of GBP348,000 in the first half of 2015 comprise
the interest costs of the AMSCI loan facility from January until it
was repaid at the end of April and the Oberland loan facility for
the period since the start of May. The GBP212,000 in 2014 arose on
the GBP5 million loan facility provided by Vulpes Life Sciences
Fund during the first half of 2014, and which was fully repaid in
June 2014.
The net tax credit of GBP2.5 million (H1 2014: GBP0.8 million)
represents amounts recoverable under current legislation for UK
R&D tax credits. The significant increase in 2015 is caused by
increases in the tax credit rates during 2014 and includes an
upside arising from a successful claim for 2014 which exceeded the
estimate included in the 2014 full year financial statements.
The resulting net loss for the period of GBP6.1million was
GBP1.3 million higher than the GBP4.8 million net loss in the first
half of 2014.
Balance sheet
Non-current assets increased from GBP11.1 million at the start
of the year to GBP15.1 million at 30 June 2015 driven by the
capacity expansion programme. Additions to Property, Plant and
Equipment in the six months amounted to GBP4.6 million, with GBP3.9
million being spent on construction-related work and GBP0.6 million
on new manufacturing and laboratory equipment. During this period
the Group has completed the refurbishment of the warehouse facility
at Windrush Court which will now be used as our primary ambient
materials warehouse and substantial progress has also been made in
building the new clean room facilities at Yarnton (near Oxford).
The Group expects the construction contractors to hand over the
Yarnton facility during the third quarter and that the facility
should become operational in the fourth quarter. Work to expand the
existing manufacturing facility, Harrow House, is underway but the
need to progress carefully so as to avoid disrupting the ongoing
production in the "GMP1" suite means that this development will
last into the second half of next year. The building of the new
laboratory complex in Windrush Court is now underway following an
extensive design phase to ensure the laboratories will meet the
Group's longer term capacity needs for laboratory space and
capabilities.
Current assets have increased from GBP22.8 million at 31
December 2014 to GBP26.4 million at 30 June 2015. The cash balance
is GBP0.9 million greater and the remaining GBP2.7 million increase
arises from higher inventory and R&D tax credit balances,
although trade and other receivables are slightly lower than at the
2014 year end.
Current liabilities at 30 June 2015 at GBP8.5 million are GBP0.7
million lower than at 31 December 2014, although this is somewhat
distorted by the re-allocation of the GBP0.5 million dilapidation
provision in respect of the Medawar centre lease from non-current
to current liabilities. This is because the lease expires in March
2016. Excluding this provision, current liabilities are GBP1.3
million lower than at the year end, mainly due to lower trade and
other payables.
Non-current liabilities have increased from GBP1.5 million at 31
December 2014 to GBP15.7 million at 30 June 2015. The GBP1.0
million loan at 31 December 2014 was the AMSCI loan facility which
has since been fully repaid as it was re-financed by the Oberland
facility, announced in May 2015, of which the Group has drawn down
$25 million (GBP16.3 million). As described above, the dilapidation
provision has been re-allocated from non-current liabilities at the
end of 2014 to current liabilities at 30 June 2015.
Cash resources
Cash, cash equivalents and available for sale investments
increased from GBP14.2 million at 31 December 2014 to GBP15.1
million at 30 June 2015.
Cash used in operations in the period after interest paid was
GBP9.2 million (H1 2014: GBP5.0 million) although it should be
noted that the 2014 cash flow benefitted from the receipt of the
GBP1.6 million R&D tax credit in respect of 2013. The claim in
respect of 2014 had not been settled by 30 June 2015 but was
received in August 2015.
Cash outflows from investing activities were GBP4.6 million in
the first half of 2015 (2014: GBP3.0 million) entirely due to the
capital expenditure programme.
Cash flows from financing activities were predominantly due to
the drawdown of $25 million under the Oberland loan facility
announced in May 2015. The loan facility provided by the UK
Government's Advanced Manufacturing Supply Chain Initiative was
fully repaid following the drawdown of the Oberland loan. The
GBP87,000 proceeds from the issue of share capital arose from the
exercise of share options by employees.
The net impact on cash of the operating, investing and financing
activities was an increase in cash balances of GBP1.3 million.
Financial outlook
The Group has started the second half of 2015 with GBP15.1
million cash and a further $25 million which can be drawn down from
the Oberland loan facility. The Group will continue to utilise cash
in operating activities although, during the fourth quarter of
2015, it is expected that the Yarnton manufacturing facility will
come on line and double manufacturing capacity. This will lead to
an increase in revenues without a commensurate increase in costs as
the employees required for productions at Yarnton have already been
recruited and are being trained. The Group also anticipates that a
portion of the process development milestones which may be earned
under the Novartis contract could be recognised in the second half
of 2015. Capital expenditure will increase in the second half of
2015 as the Group completes the Yarnton facility and continues with
the current Harrow House expansion phase. Most of the work on the
Windrush Court laboratories is also expected to be carried out
during the next six months.
Principal risks and uncertainties
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The principal risks and uncertainties facing the Group are those
set out in the 2014 Annual Report & Accounts which is available
on the Group's website at www.oxfordbiomedica.co.uk. The principal
risks and uncertainties remain the same for the second six months
of the year.
Going concern
Having reassessed the principal risks and uncertainties in the
business, the Directors consider it appropriate to adopt the going
concern basis of accounting in preparing the interim financial
information.
Consolidated Statement of Comprehensive Income
for the six months ended 30 June 2015
Six months ended 30 June 2015 Six months ended 30 June 2014
Notes GBP'000 GBP'000
------------------------------------------------ ------ ----------------------------- -----------------------------
Revenue 4,382 4,727
Cost of sales (2,385) (1,861)
-------------------------------------------------------- ----------------------------- -----------------------------
Gross profit 1,997 2,866
Research & Development costs (9,201) (6,857)
Administrative expenses (2,507) (1,823)
Other operating income 1,439 396
-------------------------------------------------------- ----------------------------- -----------------------------
Operating loss (8,272) (5,418)
Finance income 20 6
Finance costs (348) (212)
-------------------------------------------------------- ----------------------------- -----------------------------
Loss before tax (8,600) (5,624)
Taxation 2,475 823
-------------------------------------------------------- ----------------------------- -----------------------------
Loss for the period (6,125) (4,801)
Total recognised comprehensive expense for the period
attributable to owners of the parent (6,125) (4,801)
-------------------------------------------------------- ----------------------------- -----------------------------
Basic loss and diluted loss per ordinary share (0.24p) (0.32p)
-------------------------------------------------------- ----------------------------- -----------------------------
The notes on pages 13 to 17 form part of this financial
information.
Consolidated Balance Sheet
as at 30 June 2015
30 June 31 December
2015 2014
Notes GBP'000 GBP'000
------------------------------ ----- --------- -----------
Assets
Non-current assets
Intangible assets 1,924 2,106
Property, plant and equipment 6 13,138 8,944
15,062 11,050
------------------------------ ----- --------- -----------
Current assets
Inventory 7 2,023 1,407
Trade and other receivables 8 4,749 5,153
Current tax assets 4,480 2,000
Cash and cash equivalents 9 15,116 14,195
------------------------------ ----- --------- -----------
26,368 22,755
------------------------------ ----- --------- -----------
Current liabilities
Trade and other payables 10 5,226 6,304
Deferred income 11 2,719 2,927
Provisions 13 536 -
------------------------------ ----- --------- -----------
8,481 9,231
------------------------------ ----- --------- -----------
Net current assets 17,887 13,524
------------------------------ ----- --------- -----------
Non-current liabilities
Loans 12 15,694 1,000
Provisions 13 - 535
------------------------------ ----- --------- -----------
15,694 1,535
------------------------------ ----- --------- -----------
Net assets 17,255 23,039
------------------------------ ----- --------- -----------
Shareholders' equity
Share capital 14 25,686 25,659
Share premium 14 141,675 141,615
Merger reserve 2,291 2,291
Treasury reserve (102) (226)
Other reserves (682) (682)
Accumulated losses (151,613) (145,618)
------------------------------ ----- --------- -----------
Total equity 17,255 23,039
------------------------------ ----- --------- -----------
The notes on pages 13 to 17 form part of this financial
information.
Consolidated Statement of Cash Flows
for the six months ended 30 June 2015
Six months
ended Six months
30 June ended
2015 30 June 2014
Notes GBP'000 GBP'000
-------------------------------------- ----- ---------- -------------
Cash flows from operating activities
Cash used in operations 15 (8,913) (6,358)
Tax credit received - 1,603
Interest paid (321) (212)
Overseas tax paid (5) -
-------------------------------------- ----- ---------- -------------
Net cash used in operating activities (9,239) (4,967)
-------------------------------------- ----- ---------- -------------
Cash flows from investing activities
Purchases of property, plant and
equipment (4,644) (50)
Net maturity of available for
sale investments - (3,000)
Interest received 23 6
-------------------------------------- ----- ---------- -------------
Net cash generated by investing
activities (4,621) (3,044)
-------------------------------------- ----- ---------- -------------
Cash flows from financing activities
Loans received / repaid 12 15,107 1,000
Proceeds from issue of ordinary
share capital 87 21,568
Costs of share issues - (1,472)
-------------------------------------- ----- ---------- -------------
Net cash generated by financing
activities 15,194 21,096
-------------------------------------- ----- ---------- -------------
Net increase in cash and cash
equivalents 1,334 13,085
Cash and cash equivalents at 1
January 14,195 2,169
Effects of exchange rate changes (413) -
-------------------------------------- ----- ---------- -------------
Cash and cash equivalents at period
end 9 15,116 15,254
-------------------------------------- ----- ---------- -------------
The notes on pages 13 to 17 form part of this financial
information.
Statement of Changes in Equity Attributable to Owners of the
Parent
for the six months ended 30 June 2015
Share Share Merger Treasury Accumulated
capital premium reserve reserve Other reserves Losses Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
------------------------------ -------- -------- -------- -------- -------------- ----------- --------
At 1 January 2014 14,162 130,304 14,310 - (682) (149,196) 8,898
Six months ended 30 June
2014:
------------------------------ -------- -------- -------- -------- -------------- ----------- --------
Exchange adjustments - - - - - - -
Loss for the period - - - - - (4,801) (4,801)
------------------------------ -------- -------- -------- -------- -------------- ----------- --------
Total comprehensive expense
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for the period - - - - - (4,801) (4,801)
Transactions with owners:
Share options
Value of employee services - - - - - 102 102
Issue of shares excluding
options 10,784 10,784 - - - - 21,568
Cost of share issues - (1,472) - - - - (1,472)
------------------------------ -------- -------- -------- -------- -------------- ----------- --------
At 30 June 2014 24,946 139,616 14,310 - (682) (153,895) 24,295
Six months ended 31 December
2014:
------------------------------ -------- -------- -------- -------- -------------- ----------- --------
Exchange adjustments - - - - - - -
Loss for the period - - - - - (3,860) (3,860)
------------------------------ -------- -------- -------- -------- -------------- ----------- --------
Total comprehensive expense
for the period - - - - - (3,860) (3,860)
Transactions with owners:
Share options
Value of employee services - - - - - 118 118
Issue of shares excluding
options 713 1,987 - - - - 2,700
Costs of share issue - 12 - - - - 12
Realisation of merger reserve - - (12,019) - - 12,019 -
Deferred share award - - - (226) - - (226)
------------------------------ -------- -------- -------- -------- -------------- ----------- --------
At 31 December 2014 25,659 141,615 2,291 (226) (682) (145,618) 23,039
Six months ended 30 June
2015:
------------------------------ -------- -------- -------- -------- -------------- ----------- --------
Exchange adjustments - - - - - - -
Loss for the period - - - - - (6,125) (6,125)
------------------------------ -------- -------- -------- -------- -------------- ----------- --------
Total comprehensive expense
for the period - - - - - (6,125) (6,125)
Transactions with owners:
Share options
Value of employee services - - - - - 254 254
Issue of shares excluding
options 27 60 - - - - 87
Vesting of deferred share
award - - - 124 - (124) -
------------------------------ -------- -------- -------- -------- -------------- ----------- --------
At 30 June 2015 25,686 141,675 2,291 (102) (682) (151,613) 17,255
------------------------------ -------- -------- -------- -------- -------------- ----------- --------
The notes on pages 13 to 17 form part of this financial
information.
Notes to the Financial Information
1. General information and basis of preparation
These condensed consolidated interim financial statements for
the six months ended 30 June 2015 have been prepared in accordance
with the Disclosure and Transparency Rules of the Financial
Services Authority and with IAS 34 Interim Financial Reporting as
adopted by the European Union. They do not include all of the
information required for full annual financial statements and
should be read in conjunction with the consolidated financial
statements of the Group for the year ended 31 December 2014.
These condensed consolidated interim financial statements do not
constitute statutory accounts within the meaning of Section 434 of
the Companies Act 2006. Statutory accounts for the year ended 31
December 2014 were approved by the Board of Directors on 12 March
2015 and have been delivered to the Registrar of Companies. The
report of the Auditors on the 2014 accounts was unqualified.
These condensed consolidated interim financial statements were
approved by the Board of Directors on 26 August 2015. They have not
been audited.
The Company is a public limited company incorporated and
domiciled in the UK. The Company is listed on the London Stock
Exchange.
2. Going concern
Having reassessed the principal risks and uncertainties in the
business, the Directors consider it appropriate to adopt the going
concern basis of accounting in preparing the interim financial
information.
3. Accounting policies
The accounting policies applied in these interim financial
statements are consistent with those of the annual financial
statements for the year ended 31 December 2014, as described in
those annual financial statements.
Accounting developments
The Directors have considered all new standards, amendments to
standards and interpretations which are mandatory for the first
time for the financial year beginning 1 January 2015 and there are
none which impact the group in the period.
Use of estimates and assumptions
In applying the Group's accounting policies, management is
required to make judgements and assumptions concerning the future
in a number of areas. Actual results may be different from those
estimated using these judgements and assumptions.
In preparing these interim financial statements, the significant
judgements made by management in applying the Group's accounting
policies and the key sources of estimation uncertainty were in the
same areas as those that applied to the consolidated financial
statements for the year ended 31 December 2014. Specifically these
are revenue recognition, intangible asset impairment, and going
concern.
Seasonality
The Group's operations are not subject to seasonal
fluctuations.
4. Segmental analysis
The chief operating decision-maker has been identified as the
Senior Executive Team (SET), comprising the Executive Directors,
Kyriacos Mitrophanous and James Miskin. The SET considers that the
business comprises a single activity, which is biotechnology
research and development, and the related manufacturing. The SET
reviews the Group's financial performance on a whole-company,
consolidated basis in order to assess performance and allocate
resources. Therefore the segment financial information is the same
as that set out in the consolidated statement of comprehensive
income, the consolidated balance sheet, the consolidated statement
of cash flows and the consolidated statement of changes in
equity.
5. 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
2,567,485,430 in issue during the six months ended 30 June 2015
(six months ended 30 June 2014: 1,499,563,938).
As the Group is loss-making, there were no potentially-dilutive
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.
6. Property, plant & equipment
Short Office Manufactu-ring Assets
Freehold leasehold equipment and Laboratory under
property improvements and computers equipment construc-tion(1) Total
GBP'000 GBP'000 GBP'000 GBP'000 GBP'000 GBP'000
------------------ --------- ------------- -------------- --------------- ----------------- -------
Cost
At 1 January 2015 6,887 2,623 820 5,335 646 16,311
Additions at cost 454 - 198 575 3,417 4,644
At 30 June 2015 7,341 2,623 1,018 5,910 4,063 20,955
------------------ --------- ------------- -------------- --------------- ----------------- -------
Depreciation
At 1 January 2015 698 2,579 595 3,495 - 7,367
Charge for the
period 112 21 58 259 - 450
At 30 June 2015 810 2,600 653 3,754 - 7,817
------------------ --------- ------------- -------------- --------------- ----------------- -------
Net book amount
at
30 June 2015 6,531 23 365 2,156 4,063 13,138
------------------ --------- ------------- -------------- --------------- ----------------- -------
(1) Assets under construction represents the capitalisation of
ongoing construction works at the Harrow House and Yarnton
manufacturing facilities. The opening balance within Assets under
construction was included in Freehold property and Short leasehold
improvements in the 2014 year-end financial statements
7. Inventory
30 June 31 December
2015 2014
GBP'000 GBP'000
----------------- -------- -----------
Raw materials 1,440 1,214
Work-in-progress 583 193
----------------- -------- -----------
Inventory 2,023 1,407
----------------- -------- -----------
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