TIDMOXB
RNS Number : 3706J
Oxford Biomedica PLC
02 April 2015
Oxford BioMedica
2014 Annual Report and Accounts & AGM Notification
London, UK - 2 April 2015: Oxford BioMedica plc ("Oxford
BioMedica" or "the Group") (LSE:OXB), a leading gene and cell
therapy group, gives notice that copies of the 2014 Annual Report
and Accounts and the Notice of Annual General Meeting ("AGM") have
been sent to shareholders. These documents are available on the
"Investors" section of the Group's website at
www.oxfordbiomedica.co.uk. Oxford BioMedica plc announced
preliminary results for the year ended 31 December 2014 on 13 March
2015.
Copies of these documents have been submitted to the UK Listing
Authority for publication through the National Storage Mechanism
and will shortly be available for inspection at
http://www.hemscott.com/nsm.do.
Further copies of the 2014 Annual Report and Accounts are
available from the Group Secretary, Oxford BioMedica plc, Windrush
Court, Transport Way, Oxford, OX4 6LT, United Kingdom (telephone
number: +44 (0) 1865 783 000).
Oxford BioMedica plc also announces that its AGM will be held on
Thursday 7 May 2015. The meeting will be held at the offices of
Covington & Burling LLP, 265 Strand, London WC2R 1BH,
commencing at 10.00 a.m.
In accordance with the requirements of Rule 6.3.5 of the
Disclosure Rules and Transparency Rules of the UK Financial Conduct
Authority, the appendix to this announcement contains descriptions
of the principal risks and uncertainties affecting the Group and
material related party transactions, and a responsibility statement
which has been extracted from the 2014 Annual Report and Accounts.
This announcement should be read in conjunction with, and not as a
substitute for, reading the full 2014 Annual Report and
Accounts.
- Ends -
For further information, please
contact:
Oxford BioMedica plc: Tel: +44 (0)1865
John Dawson, Chief Executive Officer 783 000
Tim Watts, Chief Financial Officer
Consilium Strategic Communications Tel: +44 (0)20
Mary-Jane Elliott/Matthew Neal/Chris 3709 5700
Welsh/Laura Thornton
Notes for editors
About Oxford BioMedica(R)
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 LentiVector(R)
IP and gene delivery system technology platform and unique tumour
antigen (5T4), Oxford BioMedica is advancing its pipeline of seven
gene therapy products addressing diseases for which there are
currently no treatments or that are inadequately treated today,
including ocular 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 Corp. In addition, the Group has licenced products
and IP to Sanofi, Pfizer, GlaxoSmithKline, MolMed, Sigma-Aldrich,
Biogen Idec, Emergent BioSolutions and ImaginAb. Further
information is available at www.oxfordbiomedica.co.uk and
www.oxbsolutions.co.uk .
Appendix
Principal risks and uncertainties
Risk assessment and evaluation is an integral part of Oxford
BioMedica's management processes. Many of the Group's risks and
uncertainties are common to all development-stage biopharmaceutical
companies. Where possible, the Group's strategy and processes are
designed to manage and mitigate these risks. The Board has overall
responsibility for the Group's systems of risk management and
internal control. The management structure of the Group allows the
Executive Directors to be closely involved in all material aspects
of risk assessment, management and mitigation. The Senior Executive
Team meets formally twice-monthly and there are three key
sub-committees covering product development, technical development
and manufacturing operations which meet monthly. These
sub-committees each regularly review the risks in their relevant
areas.
Some risks are difficult to mitigate, in particular those
related to gene therapy and its efficacy. For other risks,
management's experience, planning and vigilance can mitigate the
risks to a greater extent, for example those associated with
intellectual property and financial risk. The Board members have
relevant qualifications and experience, and they have access to
external resources where required. The Board meets regularly and
frequently enough to ensure that it is fully informed to oversee
this activity in a timely manner. The following are the principal
risks and uncertainties facing the business.
Intellectual property and patent protection risk
The Group's success depends, amongst other things, on
maintaining proprietary rights to its products and technologies and
the Board gives high priority to the strategic management of the
Group's intellectual property portfolio. However, there can be no
guarantee that the Group's products and technologies are adequately
protected by intellectual property. Furthermore, if the Group's
patents are challenged, the defence of such rights could involve
substantial costs and an uncertain outcome.
Third-party patents may emerge containing claims that impact the
Group's freedom to operate. There can be no assurance that the
Group will be able to obtain licences to these patents at
reasonable cost, if at all, or be able to develop or obtain
alternative technology. Where copyright, design right and/or "know
how" protect the Group's products or technology, there can be no
assurance that a competitor or potential competitor will not
independently develop the same or similar products or
technology.
Rights of ownership over, and rights to license and use,
intellectual property depend on a number of factors, including the
circumstances under which the intellectual property was created and
the provisions of any agreements covering such intellectual
property.
There can be no assurance that changes to the terms within
licence agreements will not affect the entitlement of the Group to
the relevant intellectual property or to license the relevant
intellectual property from others.
Gene therapy risk
The commercial success of the Group's gene therapy products will
depend, in part, on their acceptance by the medical community and
the public for the prevention and/or treatment of diseases. To date
only one gene therapy product has been approved in Europe, and none
in the USA. Furthermore, specific regulatory requirements, over and
above those imposed on other products, apply to gene therapy and
there can be no assurance that additional requirements will not be
imposed in the future. This may increase the cost and time required
for successful development of the Group's products.
Development risks
To develop a pharmaceutical product it is necessary to conduct
pre-clinical studies and human clinical trials for product
candidates to demonstrate safety and efficacy. The number of
pre-clinical studies and clinical trials that will be required
varies depending on the product candidate, the indication being
evaluated, the trial results and the regulations applicable to the
particular product candidate. In addition, the Group or its
partners will need to obtain regulatory approvals to conduct
clinical trials and manufacture drugs before they can be
marketed.
This development process takes many years. The Group may fail to
develop successfully a product candidate for many reasons,
including:
- Failure to demonstrate long-term safety;
- Failure to demonstrate efficacy;
- Failure to develop technical solutions to achieve necessary
dosing levels or acceptable delivery mechanisms;
- Failure to establish robust manufacturing processes;
- Failure to find a development partner or alternative funding;
- Failure to obtain regulatory approvals to conduct clinical
studies or, ultimately, to market the product; and
- Failure to recruit sufficient patients into clinical studies.
The failure of the Group to develop successfully a product
candidate could adversely affect the future profitability of the
Group. There is a risk that the failure of any one product
candidate could have a significant and sustained adverse impact on
the Group's share price. There is also the risk that the failure of
one product candidate in clinical development could have an adverse
effect on the development of other product candidates, or on the
Group's ability to enter into collaborations in respect of product
candidates.
(i) Safety risks
Safety issues may arise at any stage of the drug development
process. An independent drug safety monitoring board (DSMB), the
relevant regulatory authorities or the Group itself may suspend or
terminate clinical trials at any time. There can be no assurances
that any of the Group's product candidates will ultimately prove to
be safe for human use. Adverse or inconclusive results from
pre-clinical testing or clinical trials may substantially delay, or
halt, the development of product candidates, consequently affecting
the Group's timeline for profitability. The continuation of a
particular study after review by an independent data safety
monitoring board or review body does not necessarily indicate that
all clinical trials will ultimately be successfully completed.
(ii) Efficacy risks
Human clinical studies are required to demonstrate efficacy in
humans when compared against placebo and/or existing alternative
therapies. The results of pre-clinical studies and initial clinical
trials of the Group's product candidates do not necessarily predict
the results of later stage clinical trials. Unapproved product
candidates in later stages of clinical trials may fail to show the
desired efficacy despite having progressed through initial clinical
trials. There can be no assurance that the efficacy data collected
from the pre-clinical studies and clinical trials of the Group's
product candidates will be sufficient to satisfy the relevant
regulatory authorities that the product should be given a marketing
authorisation.
(iii) Technical risks
During the course of a product's development, further technical
development may be required to improve the product's
characteristics such as the delivery mechanism or the manufacturing
process. There is no certainty that such technical improvements or
solutions can be identified.
(iv) Manufacturing process risk
There can be no assurance that the Group's product candidates
will be capable of being produced in commercial quantities at
acceptable cost. The Group's LentiVector(R) platform product
candidates use specialised manufacturing processes for which there
are only a few suitable manufacturers including the Group's own
facility. There can be no assurance that the Group will be able to
manufacture the Group's product candidates at economic cost or that
contractors who are currently able to manufacture the Group's
product candidates will continue to make capacity available at
economic prices, or that suitable new contractors will enter the
market. Manufacturing processes that are effective and practical at
the small scale required by the early stages of clinical
development may not be appropriate at the larger scale required for
later stages of clinical development or for commercial supply.
There can be no assurance that the Group will be able to adapt
current processes or develop new processes suitable for the scale
required by later stages of clinical development or commercial
supply in a timely or cost-effective manner, nor that contract
manufacturers will be able to provide sufficient manufacturing
capacity when required.
(v) Collaboration and funding risk
Collaborations and licensing are an important component of the
Group's strategy to realise value and manage risk. The Group is
dependent on collaborative relationships with third parties to
facilitate and fund the research, development, manufacture,
commercialisation and marketing of products. There is no guarantee
that such collaborations and funding will be found. There can also
be no assurance that the Group's existing relationships will not be
terminated or require re-negotiation for reasons that may be
unrelated to the potential of the programme. Circumstances may also
arise where the failure by collaborators and third parties, such as
contract manufacturers, to perform their obligations in accordance
with our agreements could delay, or halt entirely, development,
production or commercialisation of our products, or adversely
impact our cash flows.
(vi) Regulatory risk
The clinical development and marketing approval of the Group's
product candidates, and the Group's manufacturing facility, are
regulated by healthcare regulatory agencies, such as the FDA (USA),
EMA (Europe), and MHRA (UK). During the development stage,
regulatory reviews of clinical trial pplications or amendments can
prolong development timelines. Similarly, there can be no assurance
of gaining the necessary marketing approvals to commercialise
products in development. Regulatory authorities may impose
restrictions on a product's use or may require additional data
before granting approval. If regulatory approval is obtained, the
product and manufacturer will be subject to continual review and
there can be no assurance that such an approval will not be
withdrawn or restricted.
The Group's laboratories, manufacturing facility and conduct of
clinical studies are also subject to regular audits by the MHRA to
ensure that they comply with Good Laboratory Practice (GLP), Good
Manufacturing Practice (GMP) and Good Clinical Practice (GCP)
standards. Failure to meet such standards could result in the
laboratories or the manufacturing site being closed or the clinical
studies suspended until corrective actions have been implemented
and accepted by the regulator.
(vii) Failure to recruit sufficient patients into clinical
studies
Clinical trials are established under specific protocols which
specify how the trials should be conducted. Protocols specify the
number of patients to be recruited into the study and the
characteristics of patients who can and cannot be accepted into the
study. The risk exists that it proves difficult in practice to
recruit the number of patients with the specified characteristics.
This could be caused by a variety of reasons such as the specified
characteristics being too tightly defined resulting in a very small
population of suitable patients, or the emergence of a competing
drug, either one that is approved or another drug in the clinical
stage of development.
Longer-term commercialisation risks
In the longer term, the success of the Group's products will
depend on the regulatory and commercial environment several years
into the future. Future commercialisation risks include:
- The emergence of new and/or unexpected competitor products or
technologies. The biotechnology and pharmaceutical industries are
subject to rapid technological change which could affect the
success of the Group's product candidates or make them
obsolete;
- Regulatory authorities becoming increasingly demanding
regarding efficacy standards or risk averse regarding safety;
- Governments or other payers being unwilling to pay
for/reimburse gene therapy products at a level which would justify
the investment. Based on clinical studies to date, the Group's
LentiVector(R) platform product candidates have the unique
potential to provide permanent therapeutic benefit from a single
administration. The pricing of these therapies will depend on
assessments of their cost-benefit and cost effectiveness;
- The willingness of physicians and/or healthcare systems to
adopt new treatment regimes. Any or all of these risks could result
in the Group's future profitability being adversely affected as
future royalties and milestones from commercial partners could be
reduced.
Manufacturing operations risk
The Group manufactures clinical study material for its own
product development and for third parties.
The manufacturing processes for gene and cell therapy products
are still relatively immature. There is a risk of contamination or
other process failure during the manufacturing process which
results in material which has been produced having to be destroyed
and re-manufactured at additional cost.
Attraction and retention of key employees
Whilst the Group has entered into employment arrangements with
each of its key personnel with the aim of securing their services,
the retention of their services cannot be guaranteed. The Group is
significantly dependent on certain scientific and management
personnel. Incentivisation of key employees to remain with the
Group remains critical to the Group's success. The loss of those
employees could weaken the Group's scientific and management
capabilities, resulting in delays in the development of its drugs
and impacting negatively on the Group's business. The biotechnology
industry has a highly competitive market for qualified scientific
and managerial employees. Competitors may try to recruit some of
the Group's important employees. Recruiting and retaining
management and scientific personnel as the Group develops will be
critical to the Group's success.
Financial risks
(a) Product liability and insurance risk
In carrying out its activities the Group potentially faces
contractual and statutory claims, or other types of claim from
customers, suppliers and/or investors. In addition, the Group is
exposed to potential product liability risks that are inherent in
the research, pre-clinical and clinical evaluation, manufacturing,
marketing and use of pharmaceutical products. While the Group is
currently able to obtain insurance cover, there can be no assurance
that any future necessary insurance cover will be available to the
Group at an acceptable cost, if at all, or that, in the event of
any claim, the level of insurance carried by the Group now or in
the future will be adequate, or that a product liability or other
claim would not have a material and adverse effect on the Group's
future profitability and financial condition.
(b) Foreign currency exposure
The Group records its transactions and prepares its financial
statements in pounds sterling, but some of the Group's income from
collaborative agreements and patent licences is received in US
dollars. The Group also incurs a proportion of its expenditure in
US dollars and the Euro. The Group's cash balances are
predominantly held in pounds sterling, although the Group's
Treasury Policy permits cash balances to be held in other
currencies in order to hedge foreseen foreign currency expenses. To
the extent that the Group's foreign currency assets and liabilities
in the longer term are not so well matched, fluctuations in
exchange rates between pounds sterling, the US dollar and the Euro
may result in realised and unrealised gains and losses on
translation of the underlying currency into pounds sterling that
may increase or decrease the Group's results of operations and may
adversely affect the Group's financial condition, each stated in
pounds sterling.
In addition if the currencies in which the Group earns its
revenues and/or holds its cash balances weaken against the
currencies in which it incurs its expenses, this could adversely
affect the Group's future profitability.
(c) Continuing cashflow
The Group continues to incur significant expenses and capital
expenditure as it builds a revenue generating business and develops
its portfolio of development products. The Directors have
considered the cash position in the context of going concern and
their conclusions are set out in the Chief Financial Officer's
review, the Directors' report and in Note 1 to the consolidated
financial statements in the 2014 Annual Report and Accounts.
Transactions with related parties
Vulpes Loan Facility
On 6 January 2014, shareholders approved a GBP5 million secured
loan facility provided by Vulpes Life Sciences Fund to the Group.
Martin Diggle, a non-Executive Director of the Company is a founder
of Vulpes Investment Management which manages Vulpes Life Sciences
Fund.
During the first 6 months of 2014, the Group drew down GBP1.5
million of this facility. This amount was repaid in full, together
with accumulated interest and arrangement fee, on 17 June 2014
following the successful fundraise.
The loan agreement has now been cancelled.
Statement of Directors' responsibilities
The Directors are responsible for preparing the Annual Report,
the Directors' remuneration report and the financial statements in
accordance with applicable law and regulations.
Company law requires the directors to prepare financial
statements for each financial year. Under that law the Directors
have prepared the group and parent company financial statements in
accordance with International Financial Reporting Standards (IFRSs)
as adopted by the European Union. Under company law the Directors
must not approve the financial statements unless they are satisfied
that they give a true and fair view of the state of affairs of the
Group and the Company and of the profit or loss of the Group for
that period. In preparing these financial statements, the Directors
are required to:
- select suitable accounting policies and then apply them consistently;
- make judgements and accounting estimates that are reasonable and prudent;
The Directors are responsible for keeping adequate accounting
records that are sufficient to show and explain the Company's
transactions and disclose with reasonable accuracy at any time the
financial position of the Company and the Group and enable them to
ensure that the financial statements and the Directors'
remuneration report comply with the Companies Act 2006 and, as
regards the Group financial statements, Article 4 of the IAS
Regulation. They are also responsible for safeguarding the assets
of the Company and the Group and hence for taking reasonable steps
for the prevention and detection of fraud and other
irregularities.
The Directors are responsible for the maintenance and integrity
of the Company's website. Legislation in the United Kingdom
governing the preparation and dissemination of financial statements
may differ from legislation in other jurisdictions.
The Directors consider that the annual report and accounts,
taken as a whole, is fair, balanced and understandable and provides
the information necessary for shareholders to assess the Company's
performance, business model and strategy.
Each of the Directors, whose names and functions are listed
below confirm that, to the best of their knowledge:
- the Group financial statements, which have been prepared in
accordance with IFRSs as adopted by the EU, give a true and fair
view of the assets, liabilities, financial position and loss of the
Group; and
- the Directors' report contained in this section includes a
fair review of the development and performance of the business and
the position of the Group, together with a description of the
principal risks and uncertainties that it faces.
Name Function
---------------- ---------------------------------------
Nick Rodgers Chairman
Dr Andrew Heath Deputy Chairman and Senior Independent
Director
Dr Paul Blake Chief Development Officer
Martin Diggle Non-Executive Director
John Dawson Chief Executive Officer
Tim Watts Chief Financial Officer
Peter Nolan Chief Business Officer
In accordance with Section 418, Directors' reports shall include
a statement, in the case of each Director in office at the date the
Directors' report is approved, that:
(a) so far as the Director is aware, there is no relevant audit
information of which the Company's auditors are unaware; and
(b) he has taken all the steps that he ought to have taken as a
Director in order to make himself aware of any relevant audit
information and to establish that the Company's auditors are aware
of that information
This information is provided by RNS
The company news service from the London Stock Exchange
END
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