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Oxford Biomedica PLC
27 April 2021
Oxford Biomedica
2020 Annual report and Accounts & AGM Notification
London, UK - 27 April 2021: Oxford Biomedica plc ("Oxford
Biomedica", "the Company" or "the Group") (LSE:OXB), a leading gene
and cell therapy group, gives notice that copies of the 2020 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.oxb.com . Oxford Biomedica plc announced its preliminary
results for the year ended 31 December 2020 on 15 April 2021.
Copies of these documents have been submitted to the Financial
Conduct Authority for publication through the National Storage
Mechanism and will shortly be available for inspection at
https://data.fca.org.uk/#/nsm/nationalstoragemechanism.
Further copies of the 2020 Annual report and accounts are
available from the Company Secretary, Oxford Biomedica plc,
Windrush Court, Transport Way, Oxford, OX4 6LT, United Kingdom
(telephone number: +44 (0) 1865 783 000).
Oxford Biomedica plc intends to hold its AGM on Thursday 27 May
2021 at the offices of Oxford Biomedica plc, Windrush Court,
Transport Way, Oxford OX4 6LT, commencing at 3:00 p.m. Shareholders
will not be allowed to attend the AGM in light of the ongoing
COVID-19 situation and the restrictions on public gatherings that
have been implemented by the UK Government. Unfortunately this
means shareholders will not be able to attend the AGM in person but
the Company is pleased to be able to offer facilities for
Shareholders to attend virtually, ask questions and vote at the AGM
electronically in real time should they wish to do so. The details
of how to do this are set out in the Notice of Annual General
Meeting.
In accordance with the requirements of Rule 6.3.5 of the
Disclosure Guidance 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 2020 Annual report and
accounts. This announcement should be read in conjunction with, and
not as a substitute for, reading the full 2020 Annual report and
accounts.
- Ends -
For further information, please contact:
Oxford Biomedica plc: Tel: +44 (0)1865 783 000
Natalie Walter, Company Secretary
Notes for editors
Oxford Biomedica (LSE:OXB) is a leading, fully integrated, cell
and gene therapy group focused on developing life changing
treatments for serious diseases. Oxford Biomedica and its
subsidiaries (the "Group") have built a sector leading lentiviral
vector delivery platform (LentiVector(R) ), which the Group
leverages to develop in vivo and ex vivo products both in-house and
with partners. The Group has created a valuable proprietary
portfolio of gene and cell therapy product candidates in the areas
of oncology, ophthalmology, CNS disorders and liver diseases. The
Group has also entered into a number of partnerships, including
with Novartis, Bristol Myers Squibb, Sio Gene Therapies, Orchard
Therapeutics, Santen, Beam Therapeutics, Boehringer Ingelheim, the
UK Cystic Fibrosis Gene Therapy Consortium and Imperial
Innovations, through which it has long-term economic interests in
other potential gene and cell therapy products. Additionally the
group has signed a three year master supply and development
agreement with AstraZeneca for large-scale manufacturing of the
adenoviral based COVID-19 vaccine, AZD1222. Oxford Biomedica is
based across several locations in Oxfordshire, UK and employs more
than 670 people. Further information is available at
www.oxb.com
Appendix
Principal risks and uncertainties
The Group is exposed to a range of risks. Some of them are
specific to the Group's current operations, others are common to
all development stage biopharmaceutical companies. The Board have
carried out a robust assessment of the risks facing the Group,
including those which could threaten its business model and future
performance.
The Group operates in the cell and gene therapy biotechnology
sector which, by its nature, is relatively high risk compared with
other industry sectors. During 2020 there have only been a few
additional cell and gene therapy products which have been approved
for commercial use, and, consequently there are significant
financial and development risks in the sector, and the regulatory
authorities have shown caution in their regulation of such
products.
Risk assessment and evaluation is therefore an integral and
well-established part of the Group's management processes. The
Group's risk management framework incorporates the implementation
of a mitigation strategy, each tailored to the specific risk in
question. The Group has taken the decision to disclose the steps it
has taken to mitigate the risks facing the operations during the
period, representing an important development compared to the
Group's prior year approach to the disclosure of risks.
Risk management framework
The Group's risk management framework is as follows:
-- Board of Directors -- the Board has overall responsibility for risk management, determining the Group's risk
tolerance, and for ensuring the maintenance of a sound system of internal control. The Board considers risk in
the context of its agenda items at each of its formal meetings, of which there are at least six annually.
However, twice a year in March and September a full presentation to the Board on risk is provided by the Risk
Management Committee. The risk management processes are the responsibility of the Senior Executive Team but the
Audit Committee monitors the processes and their implementation as well as reviewing the Group's internal
financial controls and the internal control systems. The Audit Committee also monitors the integrity of the
financial statements of the Group and any formal announcements relating to the Group's financial performance,
reviewing significant financial reporting judgements contained in them.
-- Senior Executive Team (SET) -- the SET generally meets every week, with twice monthly-extended SET sessions in
order to discuss current business issues and consider relevant risks. During 2020, SET also held daily COVID-19
update sessions. At least twice a year, the SET meets with representatives from the Risk Management
Committee to consider the operational risk management processes and risks identified.
-- Key management committees -- the Group currently has three key management sub-committees which meet monthly and
through which much of the day-to-day business is managed. These are the extended Operational Leadership Team
(which incorporates the Quality and Manufacturing Operations Committee), the Product Development Committee and
the Technical Development Committee. SET members attend these meetings and risk management is a key feature of
each sub-committee.
-- Risk Management Committee -- the Group has a Risk Management Committee comprising senior managers from each area
of the business and chaired by the Chief of Staff. This group meets quarterly with a remit to identify and
assess risks in the business and to consider mitigation and risk management steps that can be taken. The risk
register is regularly reviewed by the SET and key risks are highlighted to the Board at each formal meeting.
-- Standard Operating Procedures -- all areas of the business have well established Standard Operating Procedures
(SOPs) which are required to be followed in order to minimise the risks inherent in the business operations.
Where these are required for GMP, GCP and GLP any deviations from the SOPs must be identified and investigated.
Compliance with such SOPs are routinely subject to audit by the relevant regulators and customers. Other SOPs,
such as financial processes, are also subject to audits.
Key risks specific to the Group's current operations
Pharmaceutical product 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 bioprocess drugs before they can be marketed.
This development process takes many years. The Group may fail to
successfully develop 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 bioprocessing processes;
- 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.
The Group has accepted this risk but looks to mitigate via
ensuring that it has several product candidates under development
in the pipeline and also seeks to collaborate with other larger
more experienced partners on product development.
(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 the DSMB or review body does not
necessarily indicate that all clinical trials will ultimately be
successfully completed. The Group has accepted this risk but looks
to mitigate the impact as much as possible through careful
assessment of any safety issues arising from the product early in
the development process and to stop the development if
required.
(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. The Group has accepted this risk but looks to
mitigate the impact as much as possible through consulation with
the regulatory authorities early in the development process to
determine what is required for market authorisation.
(iii) Technical risks
During the course of a product's development, further technical
development may be required to improve the product candidates
characteristics such as the delivery mechanism or the bioprocessing
process. There is no certainty that such technical improvements or
solutions can be identified. The Group continues to innovate in
this area using its R&D expertise in collaboration with its
customers to mitigate this risk.
(iv) Bioprocessing 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 bioprocessing processes offered by only
a few organisations including the Group itself. There can be no
assurance that the Group will be able to bioprocess the Group's
product candidates at economic cost or that contractors who are
currently able to bioprocess the Group's product candidates will
continue to make capacity available at economic prices, or that
suitable new contractors will enter the market. Bioprocessing
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 bioprocessors will be able
to provide sufficient bioprocessing capacity when required. The
Group continues to monitor and review the platform and production
processes to ensure that innovative steps are taken in order to
increase production yields.
(v) Regulatory risk
The clinical development and marketing approval of the Group's
product candidates, and the Group's bioprocessing 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 applications 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 candidates use or may require additional
data before granting approval. If regulatory approval is obtained,
the product candidate and bioprocessor 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, bioprocessing
facility and conduct of clinical studies are also subject to
regular audits by the MHRA and FDA to ensure that they comply with
GMP, GCP and GLP standards. Failure to meet such standards could
result in the laboratories or the bioprocessing site being closed
or the clinical studies suspended until corrective actions have
been implemented and accepted by the regulator. The Group consults
with the regulator early in the development process to understand
any concerns identified and looks to remedy these before they
become a major issue.
(vi) Failure to recruit sufficient patients into clinical studies
Clinical trials are established under 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, potentially causing
delays or even abandonment of the clinical study. 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. The threats from the above product
development risks are inherent in the pharmaceutical industry and
have not changed fundamentally over the last year. The Group aims
to mitigate these risks by employing experienced staff and other
external parties, such as contract research organisations to plan,
implement and monitor its product development activities and to
review progress regularly in the Group's Product Development
Committee.
Bioprocessing revenue risk
The Group receives significant revenues from bioprocessing
lentiviral vectors and adenoviral based vaccines for third parties.
Bioprocessing of lentiviral vectors and adenovirus based vaccines
is complex and bioprocessing batches may fail to meet the required
specification due to contamination or inadequate yield. Failure to
deliver batches to the required specification may lead to loss of
revenues. Furthermore, the Group relies on third parties, in some
cases sole suppliers, for the supply of raw materials and certain
out-sourced services. If such suppliers perform in an
unsatisfactory manner it could harm the Group's business. The
Group's bioprocessing and analytical facilities are subject to
regular inspection and approval by regulators and customers.
Failure to comply with the standards required could result in
production operations being suspended until the issues are
rectified with the potential for loss of revenue.
As the Group's revenues from bioprocessing are growing, the risk
to the Group has increased in the last twelve months. The Group
mitigates the risk of failing to meet required specifications by
investing in high quality facilities, equipment and employees and,
in particular, in quality management processes. In addition, the
Group mitigates the supply chain issues with looking to source
second suppliers and stockpile three months of critical material
supplies. The Group has also asked key suppliers to hold stocks in
UK warehouses in order to cover any immediate supply issues.
Outsourcing of fill and finish has also been seen as a risk, but
the Group is looking to bring this in-house in order to have more
control over the process.
Collaborator and partner risk
The Group has entered several collaborations and partnerships,
involving the development of product candidates by partners in
which the Group has a financial interest through IP licenses.
Failure of the partners to continue to develop the relevant product
candidates for any reason could result in the Group losing
potential revenues. The Group looks to mitigate this risk through
having a close relationship with the Group's partners via steering
group meetings that look at candidate selection and
progression.
Business development
The Group may seek to out-license or spin-out its in-house
product development programmes into externally funded vehicles and
may seek to arrange strategic partnerships for developing the
Group's other product candidates. The Group may not be successful
in its efforts to build these third party relationships which may
cause the development of the products to be delayed or curtailed.
The Group has enhanced the commercial development function within
the Group and is thus putting significant resources behind the
effort to find good strategic partners in order to assist in
developing the Group's other product candidates.
The Group is building a revenue generating business by providing
its LentiVector(R) platform to third parties in return for revenues
derived from process development, bioprocessing and future
royalties. The Group may be unsuccessful in building this business
for reasons including: a) failing to maintain a leadership position
in lentiviral vector technology; b) becoming uncompetitive from a
pricing perspective; and c) failure to provide an adequate service
to business partners and collaborators. The Group is continuing to
invest in its LentiVector(R) technology in order to reduce this
risk, and it also takes customer relationship management extremely
seriously to ensure that customers and partners receive the service
they expect, as indicated by the Group on pages 31 and 32 of the
Annual Report.
Attraction and retention of highly skilled employees
The Group depends on recruiting and retaining highly skilled
employees to deliver its objectives and meet its customers' needs.
The market for such employees is increasingly competitive and
failure to recruit or to retain staff with the required skills and
experience could adversely affect the Group's performance. The
Group mitigates this risk by creating an attractive working
environment and conducting benchmarking reviews in order to ensure
that the remuneration package offered to employees is comparable
with competing employers as indicated by the Group on pages 53 and
55 of the Annual Report.
Broader business risks which are applicable to the Group
The broader business risks, which the Group face as outlined
below are important and the Group looks to identify these risks
early through a horizon scanning project with the assistance of
external healthcare consultants and then outlines actions for the
business development team, the SET and ultimately the Board to
follow by way of mitigation.
Cell and gene therapy risk
The Group's commercial success, both from its own product
development and from supporting other companies in the sector, will
depend on the acceptance of cell and gene therapy by the medical
community and the public for the prevention and/or treatment of
diseases. To date only a limited number of gene therapy products
have been approved either in Europe and/or in the USA. Furthermore,
specific regulatory requirements, over and above those imposed on
other products, apply to gene and cell therapies 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 cell and gene therapy products. The Group
looks to mitigate this risk through market assessments of the
product development pathway and conducts pricing and reimbursement
studies for the cell and gene therapy product.
Rapid technical change
The cell and gene therapy sector is characterised by rapidly
changing technologies and significant competition. Advances in
other technologies in the sector could undermine the Group's
commercial prospects. The Group looks to mitigate this risk through
a horizon scanning project in order to identify the competition and
technology advances in the sector and to develop either in-house or
via in-licensing, new technologies for the Group's products and
platform.
Longer-term commercialisation risks
In the longer term, the success of the Group's product
candidates and those of its partners 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. The Group
looks to mitigate this long term commercialisation risk through a
horizon scanning project in order to identify the competition and
technology advances early, consult with regulatory authorities on a
regular basis and perform pricing and reimbursement studies on the
Group's products to identify any serious issues in advance .
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 product candidates 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 product candidates or technology, there
can be no assurance that a competitor or potential competitor will
not independently develop the same or similar product candidates 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.
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, bioprocessing,
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 and the Group 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. The Group keeps its
unhedged position under constant review. To the extent that the
Group's foreign currency assets and potential liabilities are not
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.
Special interest groups and adverse public opinion
During 2020 the Group entered into a supply agreement with
AstraZeneca for large-scale commercial manufacture of the
adenovirus vector-based COVID-19 vaccine. Such work can be subject
to adverse public opinion and has attracted the attention of
special interest groups, including those opposed to vaccination
programmes, also referred to as "anti- vaxxers". To date, the Group
has not been targeted by anti-vax campaigners, but there can be no
assurance that such groups will not, in the future, focus on the
Group's activities, or that any such public opinion would not
adversely affect the Group's operations. Adverse publicity about
the Group, its role in the manufacture of the Oxford AstraZeneca
COVID-19 vaccine, or any other part of the industry may hurt the
Group's public image, which could harm its operations, cause its
share price to decrease or impair its ability to gain market
acceptance for its products. The Group has looked to mitigate this
risk through assistance from the UK government (Centre for
Protection of National Infrastructure) on the protection of its
facilities/infrastructure and scenario planning with its external
public relations agency with regard to strategic
communications.
Cyber security
Cyber attacks seeking to compromise the confidentiality,
integrity and availability of IT systems and the data held on them
are a continuing risk to the Group. Indeed, with the Group
operating in manufacture of the Oxford AstraZeneca COVID-19 vaccine
this has increased the risk of cyber attack to the Group.
Compromised confidentiality, integrity and availability of our
assets resulting from a cyber attack would impact the Group's
ability to deliver to customers and, ultimately, its financial
performance and damage the Group's reputation. The Group has looked
to mitigate this risk through implementing robust security
monitoring to provide early detection of hostile activity on the
Group's networks and has sought assistance from the UK government
(National Cyber Security Centre) to protect the Group's IT
systems.
UK's departure from European Union ("Brexit")
The Group completed its Brexit preparations at the end of 2020.
The Group established a Brexit Taskforce that assessed the
potential impact on the Group's business following advice from the
UK and EU governing bodies and put in place mitigation
actions against issues that may arise from Brexit . .
The Group's priority was to maintain supply of products to any
customers in the EU, post Brexit. This involved the Group
establishing an Irish office, which will enable the Group to
release UK manufactured products within the EU. The Group
stockpiled three months of critical material supplies and asked key
suppliers to hold stocks in
UK warehouses in order to cover any immediate Brexit supply issues.
The Group has currently assessed the impact on its operations to
be minor. However it is not possible at this point in time to
predict the full impact of the free trade agreement with the
European Union on the Group and it could still have a material
adverse effect on the Group's business, financial condition and
results of operations.
COVID-19
As a result of the COVID-19 pandemic, the Group has conducted an
assessment of the potential financial and operational risks to the
business. While the Group is yet to experience any significant
negative impact from the virus on revenues, the Group continually
monitors the potential impact on the Group's supply chain, with a
particular focus on key manufacturing and process development
inventories.
The Group complies with government COVID-19 safe working
practices. In addition, the Group implemented a daily senior
management working group to monitor current COVID-19 developments
and GOV.UK guidance, to risk assess the Group's supply chain and to
direct the Group's phased response. The Group has worked with
staff, customers and suppliers to monitor any potential disruption
and, so far, the Group has not experienced any, and does not
currently expect to experience, significant supply issues or any
changes in overall customer demand.
The Group is aware that there is the potential for global
shortages in certain inventories. As part of its mitigation
strategy, the Group has increased, where possible, the level of
incoming materials and components held in warehouses, which will
mitigate the risk in the short term against labour shortages and
subsequent production delays at its key suppliers. These
mitigations have been successful to date but there is no guarantee
against future disruption.
The Group has a duty of care towards all employees, and
therefore the Group expects some of its staff to be required to
self-isolate to prevent the possible spread of infection. There is
also a risk that there could be disruption to production in the
event of employees becoming ill due to COVID-19. As a result, the
Group has taken action to provide a COVID secure workplace and to
mitigate the spread of infection at the Group's facilities through
enhanced cleaning processes, staggering of shifts, the provision of
hand sanitiser in common areas and the recommendation that
employees work from home if possible. The Group was also pleased to
take part in the government pilot for lateral flow testing in the
workplace and, while the testing has been voluntary, the Group has
seen high take-up of testing by employees. The Board is updated on
positive COVID-19 cases amongst the workforce at every Board
meeting and the SET receives weekly updates. Since rolling out the
lateral flow testing in the workforce, the Group has seen 15
positive cases of COVID-19, all of whom have since recovered. There
have not been any employee fatalities resulting from COVID-19. In
addition, front line production employees have been vaccinated
against COVID-19 as per the government's recommendations.
Climate change
The Group's governance and approach to climate change, including
its first voluntary disclosure using recommendations of the
Taskforce for Climate-related Financial Disclosure
(TCFD) is set out on page 62 of the Strategic Report.
The Group has assessed the impact of climate change and
concluded that there is likely to be some minor future financial
risks, which would need to be managed, but none that would
materially impact the Group's business model. This assessment is
consistent with the Sustainability Accounting Standards Board's
(SASB) Materiality Map, which indicates that the issue is not
likely to be material for the biotechnology and pharmaceutical
sector. The Group will keep this assessment under review with
reference to any future work prepared on the Materiality Map by
SASB or others. The Group expects that the impacts are likely to be
weather-related disruption at internal manufacturing sites and to
the Group's suppliers, with the prospect of increased costs of
resources and fuels. The Group plans to continue to develop its
business continuity plans with alternative manufacturing
sites and a second sourcing strategy if possible to mitigate these impacts.
Financial position
The Directors have considered the cash position in the context
of going concern and their conclusions are set out in the Financial
review page 50, the Director's report (page 126) and in note 1 to
the Consolidated financial statements (page 148) of the Annual
Report.
Statement of Directors' responsibilities
The Directors are responsible for preparing the Annual Report
and the Group and parent Company financial statements in accordance
with applicable law and regulations.
Company law requires the Directors to prepare Group and parent
Company 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) in conformity with the requirements of
the Companies Act 2006 and applicable law and have elected to
prepare the parent Company financial staements on the same basis.
In addition, the Group financial statements are required under the
UK Disclosure Guidance and Transpraency Rules to be prepared in
accordance with International Financial Reporting Standards adopted
pursant to Regulation (EC) No. 1606/2002 as it applies in the
European Union.
Under Company law the Directors must 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 parent Company and of
the Group's profit and loss for that period. In preparing each of
the Group and parent Company financial statements, the Directors
are required to:
-- select suitable accounting policies and then apply them consistently;
-- make judgements and estimates that are reasonable, relevant and reliable;
-- state whether they have been prepared in accordance with
international accounting standards in conformity with the
requirements of the Companies Act 2006 and, as regards the Group
financial statements, International Financial Reporting Standards
adopted pursuant to Regulation (EC) No. 1606/2002 as it applies in
the European Union;
-- assess the Group and parent Company ability to continue as a
going concern, disclosing as applicable, matters related to going
concern; and
-- use the going concern basis of accounting unless they either
intend to liquidate the Groupm or parent Company or to cease
operations, or to have no realistic alternatives but to do so.
The Directors are responsible for keeping adequate accounting
records that are sufficient to show and explain the Group and
parent company's transactions and disclose with reasonable accuracy
at any time the financial position of the Group and the Company and
enable them to ensure that the financial statements comply with the
Companies Act 2006. They are responsible for such internal control
as they determine as necessary to enable the preparation of
financial statements that are free from material misstatement,
whether due to fraud or error and have general responsibility for
taking such stepsas are reasonable open to them to safeguard the
assets of the Company and the Group and to prevent and detect fraud
and other irregularities.
Under applicable law and regulations, the Directors are also
responsible for preparing a Strategic Report, Directors' Report,
Directors' Remuneration Report and Corporate Governance Report that
complies with that law and those regulations.
The Directors are responsible for the maintenance and integrity
of the corporate and financial information included on the Group'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 Group and
parent 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 and parent Company's financial statements, which
have been prepared in accordance with the applicable set of
accounting standards, give a true and fair view of the assets,
liabilities, financial position and profit or loss of the Group and
parent company; and
-- the Directors' report contained on pages 124 to 131 of the
Annual report 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
-------------------------- ------------------------------------------------
Roch Doliveux Chair (from June 2020)
John Dawson Chief Executive Officer
Stuart Paynter Chief Financial Officer
Andrew Heath Non-Executive Director
Stuart Henderson Deputy Chairman and Senior Independent Director
Heather Preston Non-Executive Director
Robert Ghenchev Non-Executive Director
Sam Rasty Non-Executive Director (from December 2020)
Professor Dame Kay Davies Non-Executive Director (from March 2021)
In accordance with Section 418 of the Companies Act 2006,
Directors' report 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/she has taken all the steps that he/she ought to have
taken as a Director in order to make himself/herself aware of any
relevant audit information and to establish that the Company's
auditors are aware of that information.
Company: transactions with related parties
There is an outstanding balance of GBPnil (2019: GBP5,417) owed
to Lorenzo Tallarigo at year end. There were no other outstanding
balances in respect of transactions with Directors and connected
persons at 31 December 2020 (2019: none).
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
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For further information about how RNS and the London Stock Exchange
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Policy.
END
ACSIRMJTMTMTBTB
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April 27, 2021 09:40 ET (13:40 GMT)
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