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| Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
|---|---|---|---|---|---|
| Astrazeneca Plc | LSE:AZN | London | Ordinary Share | GB0009895292 | ORD SHS $0.25 |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 10.00 | 0.09% | 11,286.00 | 11,284.00 | 11,288.00 | 11,288.00 | 11,124.00 | 11,180.00 | 276,630 | 11:17:32 |
| Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
|---|---|---|---|---|---|
| Pharmaceutical Preparations | 45.81B | 5.96B | 3.8406 | 29.16 | 174.84B |
From Feb 2020 to Feb 2025
TIDMAZN
RNS Number : 7691Y
AstraZeneca PLC
07 March 2017
07 March 2017 14:30 GMT
ANNUAL FINANCIAL REPORT
AstraZeneca PLC (the Company) announced today the publication of its Annual Report and Form 20-F Information 2016 (Annual Report).
A copy of the Annual Report will be submitted to the National Storage Mechanism and will shortly be available for inspection at www.morningstar.co.uk/uk/nsm.
The Annual Report is also available on the Company's website at www.astrazeneca.com/annualreport2016
The Annual Report, together with the Notice of Annual General Meeting 2017 and Shareholders' Circular and a covering letter from the Chairman will be dispatched to shareholders on or about 16 March 2017.
The meeting place for the Annual General Meeting (AGM) will be the Park Plaza London Riverbank Hotel, 18 Albert Embankment, London SE1 7TJ and the AGM will commence at 2.30 pm (BST) on 27 April 2017.
EXPLANATORY NOTE AND WARNING
Solely for the purposes of complying with Disclosure and Transparency Rule (DTR) 6.3.5R and the requirements it imposes on issuers as to how to make public annual financial reports, we set out below:
- in Appendix A, the principal risks and uncertainties facing the Company;
- in Appendix B, the Directors' responsibility statement made in respect of the Financial Statements and Directors' Report contained in the Annual Report; and
- in Appendix C, a statement regarding related party transactions.
The appendices have been extracted from the Annual Report in unedited full text. This information should be read in conjunction with the Company's fourth quarter and full year results 2016 announcement, issued on 2 February 2017, which contained a condensed set of financial statements and which can be found at www.astrazeneca.com/Investors/financial-information/Financial-results. Together, these constitute the material required by DTR 6.3.5R to be communicated to the media in unedited full text through a Regulatory Information Service.
Page numbers and section cross-references in the appendices refer to pages and sections in the Annual Report. Defined terms used in the appendices refer to terms as defined in the Annual Report.
This material is not a substitute for reading the full Annual Report.
A C N Kemp
Company Secretary
7 March 2017
APPIX A
Risks and uncertainties
Operating in the pharmaceutical sector carries various inherent risks and uncertainties that may affect our business. In this section, we describe the risks and uncertainties that we consider material to our business in that they may have a significant effect on our financial condition, results of operations, and/or reputation.
These risks are not listed in any particular order of priority and have been categorised consistently with the Principal Risks detailed from page 20. Other risks, unknown or not currently considered material, could have a similar effect. We believe that the forward-looking statements about AstraZeneca in this Annual Report, identified by words such as 'anticipates', 'believes', 'expects' and 'intends', and that include, among other things, Future prospects in the Financial Review on page 76, are based on reasonable assumptions. However, forward-looking statements involve inherent risks and uncertainties such as those summarised below. They relate to events that may occur in the future, that may be influenced by factors beyond our control and that may have actual outcomes materially different from our expectations.
Hot Features
Premium
Product pipeline and Impact
IP risks
--------------------------------------- ------------------------------------
Failure or delay in delivery of pipeline or
launch of new products
-----------------------------------------------------------------------------
Our continued success Failure or delay in development
depends on the development of new product candidates
and successful launch that achieve the expected
of innovative new drugs. commercial success could
frustrate the achievement
The development of pharmaceutical of development targets,
product candidates is adversely affect the
a complex, risky and reputation of our R&D
lengthy process involving capabilities, and is
significant financial, likely to materially
R&D and other resources. adversely affect our
It may fail at any stage business and results
of the process due to of operations. See also
various factors, including Failure to achieve strategic
failure to obtain the plans or meet targets
required regulatory or and expectations on page
marketing approvals for 223.
the product candidate
or for its manufacturing Since our business model
facilities, unfavourable and strategy rely on
clinical efficacy data, the success of relatively
safety concerns, failure few compounds, the failure
to demonstrate adequate of any in line production
cost-effective benefits may have a significant
to regulatory authorities negative effect on our
and/or payers and the business or results of
emergence of competing operations.
products. More details
of projects that have Significant delays to
suffered setbacks or anticipated launch dates
failures during 2016 of new products could
can be found in the Therapy have a material adverse
Area Review. effect on our financial
position and/or results
The anticipated launch of operations. For example,
dates of major new products for the launch of products
significantly affect that are seasonal in
our business, including nature, delays in regulatory
investment in large clinical approvals or manufacturing
studies, the manufacture difficulties may delay
of pre-launch product launch to the next season
stocks, investment in which, in turn, may significantly
marketing materials pre-launch, reduce the return on
sales force training costs incurred in preparing
and the timing of anticipated for the launch for that
future revenue streams season. Furthermore,
from new Product Sales. in immuno-oncology speed
Launch dates are primarily to market is critical
driven by our development given the large number
programmes and the demands of clinical trials being
from various factors, conducted by other companies.
including adverse findings
in pre-clinical or clinical In addition, a delayed
studies, regulatory demands, launch may lead to increased
price negotiation, competitor costs if, for example,
activity and technology marketing and sales efforts
transfer. More complex need to be rescheduled
and stringent regulations or performed for longer
govern the manufacturing than expected.
and supply of biologics
products, thus impacting Failure to complete collaborative
the production and release projects in a timely,
schedules of such products cost-effective manner
more significantly. may limit our ability
to access a greater portfolio
In addition to developing of products, IP technology
products in-house, we and shared expertise.
also expand our product Disputes and difficulties
portfolio and geographical with our partners may
presence through licensing erode or eliminate the
arrangements and strategic benefits of our alliances
collaborations, which and collaborations. In
are key to growing and addition, failure to
strengthening our business. perform on the part of
The success of such arrangements parties to externalisation
is largely dependent transactions may diminish
on the technology and the future value of those
other IP rights we acquire, transactions. Delay of
and the resources, efforts launch can also erode
and skills of our partners. the term of patent exclusivity.
Disputes or difficulties
in our relationship with Competition from other
our collaborators or pharmaceutical companies
partners may arise, for means that we may be
example, due to conflicting unsuccessful in implementing
priorities or conflicts some of our intended
of interest between parties. projects or we may have
to pay a significant
In many cases we make premium over book or
milestone payments well market values for our
in advance of the commercialisation acquisitions.
of the products, with
no assurance that we
will recoup these payments.
We experience strong
competition from other
pharmaceutical companies
in respect of licensing
arrangements, strategic
collaborations, and acquisition
targets.
--------------------------------------- ------------------------------------
Difficulties in obtaining or maintaining regulatory
drug approval for products
-----------------------------------------------------------------------------
We are subject to strict Delays in regulatory
controls on the commercialisation reviews and approvals
processes for our pharmaceutical could delay our ability
products, including their to market our products
development, manufacture, and may adversely affect
distribution and marketing. our revenue. In addition,
The criteria for establishing post-approval requirements,
safety, efficacy and including additional
quality, which are essential clinical trials, could
for securing marketing result in increased costs,
approvals, may vary by and may impact the labelling
country and by region. and approval status of
Regulators can refuse currently marketed products.
to grant approval or
may require additional
data before approval
is granted, even though
the medicine may already
be launched in other
countries.
Factors, including advances
in science and technology,
evolving regulatory science,
and different approaches
to benefit/risk tolerance
by regulatory authorities,
the general public, and
other third party public
interest groups influence
the initial approvability
of new drugs. While we
seek to manage many of
these risks, unanticipated
and unpredictable policymaking
by governments and regulators,
limited regulatory authority
resources or conflicting
priorities often lead
to severe delays in regulatory
approvals.
We may be required to
conduct additional clinical
trials after a drug's
approval because a regulatory
authority may have a
concern that impacts
the benefit/risk profile
of one of our marketed
drugs or drugs currently
in development. For our
marketed drugs, new data
and meta-analyses have
the potential to drive
changes in the approval
status or labelling.
In addition, recent years
have seen an increase
in post-marketing regulatory
requirements and commitments,
and an increased call
for third party access
to regulatory and clinical
trial data packages for
independent analysis
and interpretation, and
broader data transparency.
Such transparency, while
important, could lead
to inappropriate or incorrect
data analyses which may
damage the integrity
of our products and our
Company's reputation.
--------------------------------------- ------------------------------------
Failure to obtain and enforce effective IP protection
-----------------------------------------------------------------------------
A pharmaceutical product Limitations on the availability
is protected from being of patent protection,
copied for a limited the ability to obtain
period of time under related IP rights or
certain patent rights the use of compulsory
and/or related IP rights, licensing in certain
such as Regulatory Data countries in which we
Protection or Orphan operate could allow for
Drug status. Typically, earlier entry of generic
products protected by or biosimilar competitor
such rights generate products. This could
significantly higher have a material adverse
revenues than those not effect on the pricing
protected. Our ability and sales of our products
to obtain, maintain and and, consequently, could
enforce patents and other materially adversely
IP rights in relation affect our revenues.
to our products is an
important element in More information about
protecting and recouping protecting our IP, the
our investment in R&D risk of patent litigation
and creating long-term and the early loss of
value for the business. IP rights is contained
Some countries in which in the Intellectual Property
we operate do not offer section on page 57, the
robust IP protection. Competitive pressures
This may be because IP including expiry or loss
laws are still developing, of IP rights and generic
the scope of those laws competition risk on page
is limited or the political 216 and Note 28 to the
environment does not Financial Statements
support such legislation. from page 185.
--------------------------------------- ------------------------------------
Commercialisation risks Impact
--------------------------------------- ------------------------------------
Competitive pressures including expiry or loss
of IP rights and generic competition
-----------------------------------------------------------------------------
A pharmaceutical product If we are not successful
competes with other products in obtaining, maintaining,
marketed by research-based defending or enforcing
pharmaceutical companies our exclusive rights
and with generic or biosimilar to market our products,
drugs marketed by generic particularly in the US
drug manufacturers. where we achieve our
highest Product Sales,
Approval of competitive our revenue and margins
products for the same could be materially adversely
or similar indication affected. In addition,
as one of our products unsuccessful assertion
may result in immediate of our IP rights may
and significant decreases lead to damages or other
in our revenues. liabilities to third
parties that could materially
Generic versions of products, adversely affect our
including biosimilars, financial performance.
are often sold at lower
prices than branded products, Third parties may be
as the manufacturer does awarded remedies for
not have to recoup the alleged infringement
significant cost of R&D of their IP, for example
investment and market injunctions and damages
development. Expiry or for alleged patent infringement.
loss of IP rights can In the US, courts may
materially adversely order enhanced (ie up
affect our revenues and to treble) damages for
financial condition due alleged wilful infringement
to the launch of cheaper of patents. From time
generic copies of the to time we may acquire
product in the country licences, discontinue
where the rights have activities and/or modify
expired or been lost processes to avoid claims
(see the table in the of patent infringement.
Patent Expiries of Key These steps could entail
Marketed Products section significant costs and
from page 211). For example our revenue and margins
in 2016, our US Product could be materially adversely
Sales of Crestor fell affected.
to $1,223 million (2015:
$2,844 million), following Unfavourable resolution
the launch of generics. of current and potential
future patent litigation
Additionally, the expiry may require us to make
or loss of patents covering significant provisions
other innovator companies' in our accounts relating
products may also lead to legal proceedings
to increased competition and/or could materially
and pricing pressure adversely affect our
for our own, still-patented financial condition or
products in the same results of operations.
product class due to
the availability of lower
priced generic products
in that product class.
Generic manufacturers
may also take advantage
of the failure of certain
countries to properly
enforce Regulatory Data
Protection or other related
IP rights and may launch
generics during this
protected period. This
is a particular risk
in some Emerging Markets
where appropriate patent
protection or other related
IP rights may be difficult
to obtain or enforce.
Various regulatory authorities
are implementing or considering
abbreviated approval
processes for biosimilars,
allowing quicker entry
to market for such products
and earlier than anticipated
competition for patented
biologics.
As well as facing generic
competition upon expiry
or loss of IP rights,
we also face the risk
that generic drug manufacturers
seek to market generic
versions of our products
prior to expiries of
our patents and/or the
Regulatory Exclusivity
periods. For example,
we are currently facing
challenges from numerous
generic drug manufacturers
regarding our patents
relating to key products,
including Brilinta, Faslodex,
Byetta, Daliresp, Onglyza
and Crestor.
IP rights protecting
our products may be challenged
by external parties.
We expect our most valuable
products to receive the
greatest number of challenges.
Despite our efforts to
establish and defend
robust patent protection
for our products, we
bear the risk that courts
may decide that our IP
rights are invalid and/or
that third parties do
not infringe our asserted
IP rights.
Where we assert our IP
rights but are ultimately
unsuccessful, third parties
may seek damages, alleging,
for example, that they
have been inappropriately
restrained from entering
the market. In such cases,
we bear the risk that
we incur liabilities
to those third parties.
We also bear the risk
that we may be found
to infringe patents owned
or licensed by third
parties, including research-based
and generic pharmaceutical
companies and individuals.
These third parties may
seek remedies for patent
infringement, including
injunctions (for example,
preventing the marketing
of one of our products)
and damages.
Details of material patent
litigation matters can
be found in Note 28 to
the Financial Statements
from page 185.
--------------------------------------- ------------------------------------
Price controls and reductions
-----------------------------------------------------------------------------
Most of our key markets Due to these pricing
have experienced the pressures, there can
implementation of various be no certainty that
cost control or reimbursement we will be able to charge
mechanisms for pharmaceutical prices for a product
products. that, in a particular
country or in the aggregate,
In the US, there is significant enable us to earn an
pricing pressure driven adequate return on our
by payer consolidation, product investment. These
restrictive reimbursement pressures, including
policies, and cost control the increasingly restrictive
tools, such as exclusionary reimbursement policies
formularies and price to which we are subject,
protection clauses. Many could materially adversely
formularies employ 'generic affect our business or
first' strategies and/or results of operations.
require physicians to
obtain prior approval We expect these pricing
for the use of a branded pressures will continue
medicine where a generic and may increase.
alternative exists. These
mechanisms can be used The continued disparities
by payers to limit the in EU and US pricing
use of branded products systems could lead to
and put pressure on manufacturers marked price differentials
to reduce net prices. between regions, which,
In addition, patients by way of the implementation
are seeing changes in of existing or new reference
the design of their health pricing mechanisms, increases
plan benefits and may the pricing pressure
experience variation affecting the industry.
in how their plans cover The importation of pharmaceutical
their medications, including products from countries
increases in the out-of-pocket where prices are low
payments for their branded due to government price
medications. Patient controls, or other market
out-of-pocket spending dynamics, to countries
is generally in the form where prices for those
of a co-payment or co-insurance, products are higher,
but there is a growing is already prevalent
trend towards high deductible and may increase. Strengthened
health plans that require collaboration by governments
that patients pay the may accelerate the development
full list price of their of further cost-containment
drugs and services until policies (such as joint
they meet certain out-of-pocket procurement). Increased
thresholds. Ongoing scrutiny and simplified access
of the US pharmaceutical to national and regional
industry, focused largely prices in markets and
on pricing, is placing the publication of these
increased emphasis on prices in centralised
the value of medications. databases have facilitated
This scrutiny will likely the uptake and efficiency
continue across many of price referencing
stakeholders, including across the world.
policymakers and legislators.
The new US political
leadership has initiated
various legislative and
policy processes that
could affect the ACA.
US prescription drug
costs and importation
policies could be among
the policy proposals
considered in initial
steps to repeal and replace
the ACA. In addition
to addressing the ACA
directly, lawmaker and
policymaker proposals
are also discussing a
variety of other related
changes relating to,
for example, tax and
Medicare reform. For
more information, please
see Pricing of medicines
in the Marketplace section
from page 13. Currently
it is difficult to predict
what specific proposals
may be directed at existing
laws and regulations
(including the ACA or
the Medicare Part D program)
and to determine the
implications for the
healthcare system and
pharmaceutical industry.
This uncertainty could
impact our ability to
execute our plans, strategies,
and business operations.
However, significantly
modifying existing laws
and regulations, including
the ACA and those relating
to drug pricing and importation,
could affect private
health insurance, coverage
through Medicaid and
the health insurance
exchange marketplaces,
Medicare coverage and
savings provisions, and
other facets of the US
healthcare market, with
potentially significant
impacts on the pharmaceutical
industry.
In Europe, the industry
continues to be exposed
to various ad hoc cost-containment
measures and reference
pricing mechanisms, which
impact prices. There
is a trend towards increasing
transparency and comparison
of prices among EU Member
States which may eventually
lead to a change in the
overall pricing and reimbursement
landscape.
In Emerging Markets,
governments are increasingly
controlling pricing in
the self-pay sector and
favouring locally manufactured
drugs. In addition, the
emergence of price referencing
is seen in some markets.
Concurrently, many markets
are adopting the use
of Health Technology
Assessment (HTA) to provide
a rigorous evaluation
of the clinical efficacy
of a product at, or post,
launch. HTA evaluations
are also increasingly
being used to assess
the clinical effect,
as well as cost-effectiveness,
of products in a particular
health system. This comes
as payers and policymakers
attempt to increase efficiencies
in the use and choice
of pharmaceutical products.
A summary of the principal
aspects of price regulation
and how pricing pressures
are affecting our business
in our most important
markets is set out in
Pricing of medicines
in the Marketplace section
from page 13 and overleaf
in the following risk
factor.
--------------------------------------- ------------------------------------
Economic, regulatory and political pressures
-----------------------------------------------------------------------------
Operating in over 100 Deterioration of, or
countries, we are subject failure to improve, socio-economic
to political, socio-economic conditions, and situations
and financial factors and/or resulting events,
both globally and in depending on their severity,
individual countries. could adversely affect
our supply and/or distribution
A sustained global economic chain in the affected
downturn may further countries and the ability
exacerbate pressure from of customers or ultimate
governments and other payers to purchase our
healthcare payers on medicines. This could
medicine prices and volumes adversely affect our
of sales in response business or results of
to pressures on budgets, operations.
and may cause a slowdown
or a decline in growth While we have adopted
in some markets. Those cash management and treasury
most severely impacted policies to manage the
by the economic downturn risk of not being able
may seek alternative to access a sustainable
ways to settle their flow of liquid funds
debts through, for example, (see the Financial risk
the issuance of government management policies section
bonds which might trade of the Financial Review
at a discount to the from page 76), we cannot
face value of the debt. be certain that these
Other customers may cease will be as effective
to trade, which may result as they are intended
in losses from writing to be, in particular
off debts, or a reduction in the event of a global
in demand for products. liquidity crisis. In
addition, open positions
We are highly dependent where we are owed money
on being able to access and investments we have
a sustainable flow of made in financial and
liquid funds due to the non-financial institutions
high fixed costs of operating or money market funds
our business and the cannot be guaranteed
long and uncertain development to be recoverable. Additionally,
cycles of our products. if we need access to
In a sustained economic external sources of financing
downturn, financial institutions to sustain and/or grow
with whom we deal may our business, such as
cease to trade and there the debt or equity capital
can be no guarantee that financial markets, this
we will be able to access may not be available
monies owed to us without on commercially acceptable
a protracted, expensive terms, if at all, in
and uncertain process, the event of a severe
if at all. and/or sustained economic
downturn. This may, for
More than 90% of our instance, be the case
cash investments are in the event of any default
managed centrally and by the Company on its
are invested in collateralised debt obligations, which
bank deposits, fixed may materially adversely
income securities in affect our ability to
government, financial secure debt funding in
and non-financial securities the future or our financial
and AAA credit rated condition in general.
institutional money market Further information on
funds. Money market funds debt funding arrangements
are backed by institutions is contained in the Financial
in the US and the EU, risk management policies
which, in turn, invest section of the Financial
in other funds, including Review from page 76.
sovereign funds. This
means our credit exposure It is too early to judge
is a mix of US and EU the impact of Brexit
sovereign default risk, as it is unclear as to
financial institution the trading relationships
and non-financial institution the UK will be able to
default risk. negotiate with the EU
and other significant
On 23 June 2016, the trading partners. Any
UK held a remain-or-leave deterioration in market
referendum on the UK's access or trading terms
membership within the including customs duties,
EU, the outcome of which VAT or other tariffs
was a decision for the that constitute real
UK to exit from the EU cost or delay to the
(Brexit). A process of movement of goods and
negotiation will likely increased administration
determine the future may materially adversely
terms of the UK's relationship impact our financial
with the EU, as well performance.
as whether the UK will
be able to continue to
benefit from the EU's
free trade and similar
arrangements. Until the
Brexit negotiation process
is initiated and completed,
it is difficult to anticipate
the potential impact
on AstraZeneca's market
share, sales, profitability
and results of operations.
The Group operates from
a global footprint and
retains flexibility to
adapt to changing circumstances.
The uncertainty before,
during and after the
period of negotiation
is also expected to increase
volatility and may have
an economic impact, particularly
in the UK and Eurozone.
The Board reviews the
potential impact of Brexit
as an integral part of
its Principal Risks (as
outlined from page 20)
rather than as a stand-alone
risk. As the process
of Brexit evolves, the
Board will continue to
assess its impact on
the Company.
--------------------------------------- ------------------------------------
Failures or delays in the quality and execution
of our commercial strategies
-----------------------------------------------------------------------------
Commercial success of Failure to execute our
our Growth Platforms commercial strategies
are critical factors could materially adversely
in sustaining or increasing impact our business or
global Product Sales results of operations.
and replacing lost Product
Sales due to patent expiry. If a new product does
The successful launch not succeed as anticipated
of a new pharmaceutical or its rate of sales
product involves substantial growth is slower than
investment in sales and anticipated, there is
marketing activities, a risk that we may be
launch stocks and other unable to fully recoup
items. We may ultimately the costs incurred in
be unable to achieve launching it, which could
commercial success for materially adversely
various reasons including affect our business or
difficulties in manufacturing results of operations.
sufficient quantities
of the product candidate Due to the complexity
for development or commercialisation of the commercialisation
in a timely manner, the process for biologics,
impact of price control the methods of distributing
measures imposed by governments and marketing biologics
and healthcare authorities, could materially adversely
the outcome of negotiations impact our revenues from
with third party payers, the sales of biologics
erosion of IP rights, medicines, such as Synagis
including infringement and FluMist/Fluenz.
by third parties, failure
to show a differentiated The failure to exploit
product profile and changes potential opportunities
in prescribing habits. appropriately in Emerging
Markets or materialisation
The commercialisation of the risks and challenges
of biologics is often of doing business in
more complex than for such markets, including
small molecule pharmaceutical inadequate protection
products, primarily due against crime (including
to differences in the counterfeiting, corruption
mode of administration, and fraud) or inadvertent
technical aspects of breaches of local and
the product, and rapidly international law may
changing distribution materially adversely
and reimbursement environments. affect our reputation,
business or results of
We face particular challenges operations.
in Emerging Markets,
including: Integration processes
may also result in business
> More volatile economic disruption, diversion
conditions and/or political of management resources,
environments. the loss of key employees
> Competition from multinational and other issues, such
and local companies with as a failure to integrate
existing market presence. IT and other systems.
> The need to identify
and to leverage appropriate The incurrence of significant
opportunities for sales debt or liabilities due
and marketing. to the integration of
> Poor IP protection. an acquired business
> Inadequate protection could cause deterioration
against crime (including in our credit rating
counterfeiting, corruption and result in increased
and fraud). borrowing costs and interest
> The need to impose expense. We may issue
developed market compliance additional shares to
standards. pay for acquired businesses,
> The need to meet a which would result in
more diverse range of the dilution of our then
national regulatory, existing shareholders.
clinical, manufacturing
and distribution requirements.
> Potential inadvertent
breaches of local and
international law.
> Not being able to recruit
appropriately skilled
and experienced personnel.
> Difficulty in identifying
the most effective sales
and marketing channels
and routes to market.
> Intervention by national
governments or regulators
restricting market access
and/or introducing adverse
price controls.
> Difficulty in managing
local partnerships such
as co-promotion and co-marketing;
both driving performance
and adhering to AstraZeneca's
compliance standards
which are often higher
than the market norm.
> Difficulties in cash
repatriation due to strict
foreign currency controls
and lack of hard currency
reserves in some Emerging
Markets.
> Complexity inherent
within a direct exports
business from UK and
Sweden operations to
countries where we do
not have a legal entity.
We may also seek to acquire
complementary businesses
or enter into other strategic
transactions. The integration
of an acquired business
could involve incurring
significant debt and
unknown or contingent
liabilities, as well
as having a negative
effect on our reported
results of operations
from acquisition-related
charges, amortisation
of expenses related to
intangibles and charges
for the implementation
of long-term assets.
We may also experience
difficulties in integrating
geographically separated
organisations, systems
and facilities, and personnel
with different organisational
cultures. Disputes or
difficulties in our relationship
with our collaborators
or partners may also
arise, often due to conflicting
priorities or conflicts
of interest between parties.
--------------------------------------- ------------------------------------
Supply chain and business Impact
execution risks
--------------------------------------- ------------------------------------
Failure to maintain supply of compliant, quality
product
-----------------------------------------------------------------------------
We may experience difficulties, Difficulties with manufacturing
delays and interruptions and supply, forecasting,
in the manufacturing distribution or third
and supply of our products party suppliers may result
for various reasons, in product shortages,
including: which may lead to lost
Product Sales and materially
> Demand significantly adversely affect our
in excess of forecast reputation and revenues.
demand, which may lead Even slight variations
to supply shortages (this in components or any
is particularly challenging part of the manufacturing
before launch). process may lead to a
> Supply chain disruptions, product that is non-compliant
including those due to and does not meet quality
natural or man-made disasters standards. This could
at one of our facilities lead to recalls, spoilage,
or at a critical supplier product shortage, regulatory
or vendor. action and/or reputational
> Delays in construction harm.
of new facilities or
the expansion of existing
facilities, including
those intended to support
future demand for our
products (the complexities
associated with biologics
facilities, especially
for drug substance, increases
the probability of delay).
> The inability to supply
products due to a product
quality failure or regulatory
agency compliance action
such as licence withdrawal,
product recall or product
seizure.
> Other manufacturing
or distribution problems,
including changes in
manufacturing production
sites, limits to manufacturing
capacity due to regulatory
requirements, changes
in the types of products
produced, or physical
limitations or other
business interruptions
that could impact continuous
supply.
We increasingly rely
on third parties for
the timely supply of
goods, such as raw materials
(for example, the API
in some of our medicines
and drug substances and/or
finished drug products
for some of our biologics
medicines), equipment,
formulated drugs and
packaging, and services,
all of which are key
to our operations. Many
of these goods are difficult
to substitute in a timely
manner or at all. We
expect that external
capacity for biologics
drug substance production
will remain constrained
for the next few years
and, accordingly, may
not be readily available
for supplementary production
in the event that we
experience an unforeseen
need for such capacity.
--------------------------------------- ------------------------------------
Illegal trade in our products
-----------------------------------------------------------------------------
The illegal trade in Public loss of confidence
pharmaceutical products in the integrity of pharmaceutical
is widely recognised products as a result
by industry, non-governmental of illegal trade could
organisations and governmental materially adversely
authorities to be increasing. affect our reputation
Illegal trade includes and financial performance.
counterfeiting, theft In addition, undue or
and illegal diversion misplaced concern about
(that is, when our products this issue may cause
are found in a market some patients to stop
where we did not send taking their medicines,
them and where they are with consequential risks
not approved or not permitted/allowed to their health. Authorities
to be sold). There is may take action, financial
a risk to public health or otherwise, if they
when illegally traded believe we are liable
products enter the supply for breaches in our own
chain, as well as associated supply chains.
financial risk. Authorities
and the public expect There is also a direct
us to help reduce opportunities financial loss when,
for illegal trade in for example, counterfeit
our products through and/or illegally diverted
securing the integrity products replace sales
of our supply chain, of genuine products or
surveillance, investigation genuine products are
and supporting legal recalled following discovery
action against those of counterfeit products.
found to be engaged in
illegal trade.
--------------------------------------- ------------------------------------
Reliance on third party goods and services
-----------------------------------------------------------------------------
Many of our business-critical The failure of outsource
operations, including providers to deliver
certain R&D processes, timely services, and
IT systems, HR, finance, to the required level
tax and accounting services of quality, or the failure
have been outsourced of outsource providers
to third party providers. to cooperate with each
We are thus heavily reliant other, could materially
on these third parties adversely affect our
not just to deliver timely financial condition or
and high quality services results of operations.
but also to comply with Moreover, the failure
applicable laws and regulations of these third parties
and adhere to our ethical to operate in an ethical
business expectations manner could adversely
from third party providers. impact our reputation
both internally and externally
or even result in non-compliance
with applicable laws
and regulations.
Our business and financial
results could be materially
adversely affected by
disruptions caused by
our failure to successfully
manage either the integration
of outsourced services
or the transition process
of insourcing services
from third parties. For
instance, insourcing
some of the previously
outsourced services into
our service centre in
Chennai, India and Guadalajara,
Mexico may result in
deterioration of the
quality of service or
deployment of resources
by these third parties.
--------------------------------------- ------------------------------------
Failure of information security, data protection
and cybercrime
-----------------------------------------------------------------------------
We are dependent on effective Any significant disruption
IT systems. These systems to these IT systems,
support key business including breaches of
functions such as our data security or cybersecurity,
R&D, manufacturing, supply or failure to integrate
chain and sales capabilities new and existing IT systems,
and are an important could harm our reputation
means of safeguarding and materially adversely
and communicating data, affect our financial
including critical or condition or results
sensitive information, of operations.
the confidentiality and
integrity of which we While we invest heavily
rely on. in the protection of
our data and IT, we may
Examples of sensitive be unable to prevent
information that we protect breakdowns or breaches
include clinical trial in our systems that could
records (patient names result in disclosure
and treatments), personal of confidential information,
information (employee damage to our reputation,
bank details, home address), regulatory penalties,
IP related to manufacturing financial losses and/or
process and compliance, other costs.
key research science
techniques, AstraZeneca The inability to effectively
property (theft) and back up and restore data
privileged access (rights could lead to permanent
to perform IT tasks). loss of data that could
result in non-compliance
The size and complexity with applicable laws
of our IT systems, and and regulations.
those of our third party
vendors (including outsource We and our vendors could
providers) with whom be susceptible to third
we contract, have significantly party attacks on our
increased over the past information security
decade and this makes systems. Such attacks
such systems potentially are of ever-increasing
vulnerable to service levels of sophistication
interruptions and security and are made by groups
breaches from attacks and individuals with
by malicious third parties, a wide range of motives
or from intentional or and expertise, including
inadvertent actions by criminal groups, 'hacktivists'
our employees or vendors. and others. From time
to time we experience
Significant changes in intrusions, including
the business footprint as a result of computer-related
and the implementation malware.
of the IT strategy, including
the creation and use Inappropriate use of
of captive offshore Global certain media vehicles
Technology Centres, could could lead to the unauthorised
lead to temporary loss or unintentional public
of capability. disclosure of sensitive
information (such as
We increasingly use the personally identifiable
internet, digital content, information on employees,
social media, mobile healthcare professionals
applications and other or patients, such as
forms of new technology those enrolled in our
to communicate internally clinical trials), which
and externally. The accessibility may damage our reputation,
and instantaneous nature adversely affect our
of interactions with business or results of
such media may facilitate operations and expose
or exacerbate the risk us to legal risks and/or
of data leakages from additional legal obligations.
within AstraZeneca. It Similarly, the involuntary
may also lead to false public disclosure of
or misleading statements commercially sensitive
being made about AstraZeneca, information or an information
which may damage our loss could adversely
reputation. As existing affect our business or
social media platforms results of operations.
expand and evolve and In addition, negative
new social media platforms posts or comments about
emerge, it becomes increasingly us (or, for example,
challenging to identify the safety of our products)
new points of entry and on social media websites
to put structures in or other digital channels
place to secure and protect could harm our reputation.
information.
--------------------------------------- ------------------------------------
Failure of critical processes
-----------------------------------------------------------------------------
Unexpected events and/or Failure of critical processes
events beyond our control may result in an inability
could result in the failure to research, manufacture
of critical processes or supply products to
within the Company or patients. AstraZeneca
at third parties on whom has developed a Business
we are reliant. Resilience framework
which is designed to
The business faces threats mitigate such risks.
to business continuity However, there is no
from many directions. guarantee that these
Examples of material measures will be sufficient
threats include: to prevent business interruption.
> Disruption to our business This may expose the Company
if there is instability to litigation and/or
in a particular geographic regulatory action which
region, including as may result in fines,
a result of war, terrorism, loss of revenue and adversely
riots, unstable governments, affect the Company's
civil insurrection or financial results.
social unrest.
> Natural disasters in
areas of the world prone
to extreme weather events
and earthquakes.
> Cyber threats similar
to those detailed in
the Failure of information
security, data protection
and cybercrime section
above.
--------------------------------------- ------------------------------------
Any expected gains from productivity initiatives
are uncertain
-----------------------------------------------------------------------------
We continue to implement Our failure to successfully
various productivity implement these planned
initiatives and restructuring cost-reduction measures,
programmes with the aim either through the successful
of enhancing the long-term implementation of employee
efficiency of the business. relations processes (including
However, anticipated consultation, engagement,
cost savings and other talent management, recruitment
benefits from these programmes and retention), or the
are based on estimates possibility that these
and the actual savings efforts do not generate
may vary significantly. the level of cost savings
In particular, these we anticipate, could
cost-reduction measures materially adversely
are often based on current affect our business or
conditions and cannot results of operations.
always take into account
any future changes to
the pharmaceutical industry
or our operations, including
new business developments
or wage or price increases.
--------------------------------------- ------------------------------------
Failure to attract and retain key personnel,
and engage successfully with our employees
-----------------------------------------------------------------------------
We rely heavily on recruiting The inability to attract
and retaining talented and retain highly skilled
employees with a diverse personnel may weaken
range of skills and capabilities our succession plans
to meet our strategic for critical positions
objectives. in the medium term, may
materially adversely
We face intense competition affect the implementation
for well-qualified individuals, of our strategic objectives
as the supply of people and could ultimately
with specific skills impact our business or
and significant leadership results of operations.
potential or in specific
geographic regions may Failure to engage effectively
be limited. with our employees could
lead to business disruption
The successful delivery in our day-to-day operations,
of our business objectives reduce levels of productivity
is dependent on high and/or increase levels
levels of engagement, of voluntary turnover,
commitment and motivation all of which could ultimately
of the workforce. materially adversely
affect our business or
results of operations.
--------------------------------------- ------------------------------------
Legal, regulatory and Impact
compliance risks
--------------------------------------- ------------------------------------
Failure to adhere to applicable laws, rules
and regulations
-----------------------------------------------------------------------------
Our many business operations Failure to comply with
are subject to a wide applicable laws, rules
range of laws, rules and regulations; manage
and regulations from our liabilities; or to
governmental and non-governmental adequately anticipate
bodies around the world. or proactively manage
emerging policy and legal
Any failure to comply developments could materially
with these applicable adversely affect our
laws, rules and regulations licence to operate, or
may result in us being results of operations;
investigated by relevant adversely affect our
agencies and authorities reputation; cause harm
and/or in legal proceedings to people or the environment;
being filed against us. and/or lead to fines
Such investigations or or other penalties. For
proceedings could result example, once a product
in us becoming subject has been approved for
to civil or criminal marketing by the regulatory
sanctions and/or being authorities, it is subject
forced to pay fines or to continuing control
damages. Relevant authorities and regulation, such
have wide-ranging administrative as the manner of its
powers to deal with any manufacture, distribution,
failure to comply with marketing and safety
continuing regulatory surveillance. If regulatory
oversight and this could issues concerning compliance
affect us, whether such with environmental, current
failure is our own or Good Manufacturing Practice
that of our contractors or safety monitoring
or external partners. regulations for pharmaceutical
products (often referred
Material examples of to as pharmacovigilance)
statutes, rules and regulations arise, this could lead
impacting business operations to loss of product approvals,
include: product recalls and seizures,
and interruption of production,
> Compliance with Good which could create product
Manufacturing Practice. shortages and delays
> Local, national and in new product approvals,
international environment and negatively impact
or occupational health patient access.
and safety laws and regulations.
> Trade control laws
governing our imports
and exports including
nationally and internationally
recognised trade agreements,
embargoes, trade and
economic sanctions and
anti-boycott requirements.
> Competition laws and
regulations, including
challenges from competition
authorities to patent
settlement agreements
and private damages actions.
> Rules and regulations
established to promote
ethical supply chain
management.
> Financial regulations
including, but not limited
to, external financial
reporting, taxation and
money laundering.
> Employment practices.
> Disclosure of payments
to healthcare professionals
under the Sunshine Act
and EFPIA legislation.
> Appropriate disclosure
of community support,
patient group support
and product donations.
We have environmental
and/or occupational health
and safety-related liabilities
at some current, formerly
owned, leased and third
party sites. For more
information on the most
significant of these
and for details on other
significant litigation
matters, please refer
to Note 28 to the Financial
Statements from page
185.
--------------------------------------- ------------------------------------
Safety and efficacy of marketed products is
questioned
-----------------------------------------------------------------------------
Our ability to accurately Serious safety concerns
assess, prior to launch, or adverse events relating
the eventual efficacy to our products could
or safety of a new product lead to product recalls,
once in broader clinical seizures, loss of product
use can only be based approvals and interruption
on data available at of supply and could materially
that time, which is inherently adversely impact patient
limited due to relatively access, our reputation
short periods of product and financial revenues.
testing and relatively
small clinical study Significant product liability
patient samples. claims could also arise
which could be costly,
Any unforeseen safety divert management attention
concerns or adverse events or damage our reputation
relating to our products and demand for our products.
or failure to comply
with laws, rules and Unfavourable resolution
regulations relating of such current and similar
to provision of appropriate future product liability
warnings concerning the claims could subject
dangers and risks of us to enhanced damages,
our products that result require us to make significant
in injuries could expose provisions in our accounts
us to large product liability relating to legal proceedings
damages claims, settlements and could materially
and awards, particularly adversely affect our
in the US. Adverse publicity financial condition or
relating to the safety results of operations,
of a product or of other particularly where such
competing products may circumstances are not
increase the risk of covered by insurance.
product liability claims. For more information,
see the Limited third
Details of material product party insurance coverage
liability litigation risk on page 224.
matters can be found
in Note 28 to the Financial
Statements from page
185.
--------------------------------------- ------------------------------------
Adverse outcome of litigation and/or governmental
investigations
-----------------------------------------------------------------------------
We may be subject to Governmental investigations,
various product liability, for example under the
consumer commercial, Foreign Corrupt Practices
anti-trust, environmental, Act or federal or state
employment or tax litigation False Claims Acts or
or other legal proceedings other types of legal
and governmental investigations. proceedings, regardless
Litigation, particularly of their outcome, could
in the US, is inherently be costly, divert management
unpredictable and unexpectedly attention, or damage
high awards for damages our reputation and demand
can result from an adverse for our products. Unfavourable
verdict. In many cases, resolution of current
plaintiffs may claim and similar future proceedings
enhanced damages in extremely against us could subject
high amounts. In particular, us to criminal liability,
the marketing, promotional, fines, penalties or other
clinical and pricing monetary or non-monetary
practices of pharmaceutical remedies, including enhanced
manufacturers, as well damages, require us to
as the manner in which make significant provisions
manufacturers interact in our accounts relating
with purchasers, prescribers to legal proceedings
and patients, are subject and could materially
to extensive regulation, adversely affect our
litigation and governmental business or results of
investigation. Many companies, operations.
including AstraZeneca,
have been subject to
claims related to these
practices asserted by
federal and state governmental
authorities and private
payers and consumers,
which have resulted in
substantial expense and
other significant consequences.
Note 28 to the Financial
Statements from page
185 describes the material
legal proceedings in
which we are currently
involved.
--------------------------------------- ------------------------------------
Failure to adhere to increasingly stringent
anti-bribery and anti-corruption legislation
-----------------------------------------------------------------------------
There is an increasing Despite taking measures
global focus on the implementation to prevent breaches of
and enforcement of anti-bribery applicable anti-bribery
and anti-corruption legislation. and anti-corruption laws
by our personnel and
In the UK, the Bribery associated third parties,
Act 2010 has extensive breaches may still occur,
extra territorial application, potentially resulting
and imposes organisational in the imposition of
liability for any bribe significant penalties,
paid by persons or entities such as fines, the requirement
associated with an organisation to comply with monitoring
where the organisation or self-reporting obligations,
failed to have adequate or debarment or exclusion
preventative controls from government sales
in place at the time or reimbursement programmes,
of the offence. In the any of which could materially
US, there has been significant adversely affect our
enforcement activity reputation, business
in respect of the Foreign or results of operations.
Corrupt Practices Act
by the SEC and DOJ against
US companies and non-US
companies listed in the
US. China, Brazil, India
and other countries are
also enforcing their
own anti-bribery laws
more aggressively and/or
adopting tougher new
measures.
We have been the subject
of anti-corruption investigations
and there can be no assurance
that we will not, from
time to time, continue
to be subject to informal
enquiries and formal
investigations from governmental
agencies. In the context
of our business, governmental
officials interact with
us in various roles that
are important to our
operations, such as in
the capacity of a regulator,
partner or healthcare
payer, reimburser or
prescriber, among others.
Details of these matters
are included in Note
28 to the Financial Statements
from page 185.
--------------------------------------- ------------------------------------
Economic and financial Impact
risks
--------------------------------------- ------------------------------------
Failure to achieve strategic plans or meet targets
and expectations
-----------------------------------------------------------------------------
We may from time to time There can be no guarantee
communicate our business that our financial targets
strategy or our targets or expectations will
or expectations regarding materialise on the expected
our future financial timeline or at all. Actual
or other performance results may deviate materially
(for example, the expectations and adversely from any
described in Future prospects such target or expectation,
in the Financial Review including if one or more
on page 76). All such of the assumptions or
statements are of a forward-looking judgements underlying
nature and are based any such target or expectation
on assumptions and judgements proves to be incorrect
we make, all of which in whole or in part.
are subject to significant
inherent risks and uncertainties,
including those that
we are unaware of and/or
that are beyond our control.
Any failure to successfully
implement our business
strategy, whether determined
by internal or external
risk factors, may frustrate
the achievement of our
financial or other targets
or expectations and,
in turn, materially damage
our brand and materially
adversely affect our
business, financial position
or results of operations.
--------------------------------------- ------------------------------------
Unexpected deterioration in the Company's financial
position
-----------------------------------------------------------------------------
A wide range of financial Movements in the exchange
risks could result in rates used to translate
a material deterioration foreign currencies into
in the Company's financial US dollars may materially
position. adversely affect our
financial condition or
As a global business, results of operations.
currency fluctuations Some of our subsidiaries
can significantly affect import and export goods
our results of operations, and services in currencies
which are reported in other than their own
US dollars. Approximately functional currency,
35% of our global 2016 and so the financial
Product Sales were in results of such subsidiaries
the US, which is expected could be affected by
to remain our largest currency fluctuations
single market for the arising between the transaction
foreseeable future. Product and settlement dates.
Sales in other countries In addition, there are
are predominantly in foreign exchange differences
currencies other than arising on the translation
the US dollar, including of investments in subsidiaries.
the euro, Japanese yen,
Chinese renminbi and We have significant investments
Australian dollar. in goodwill and intangible
assets as a result of
Our consolidated balance our acquisitions of various
sheet contains significant businesses and our purchases
investments in intangible of certain assets, such
assets, including goodwill. as product development
The nature of the biopharmaceutical and marketing rights.
business is high risk Impairment losses may
and requires that we materially adversely
invest in a large number affect our financial
of projects in an effort condition or results
to develop a successful of operations. Details
portfolio of approved of the carrying values
products. Our ability of goodwill and intangible
to realise value on these assets, and the estimates
significant investments and assumptions we make
is often contingent upon, in our impairment testing,
among other things, regulatory are included in Notes
approvals, market acceptance, 8 and 9 to the Financial
competition and legal Statements from page
developments. As such, 156.
in the course of our
many acquisitions and Financial liabilities
R&D activities, we expect arising due to product
that some of our intangible liability or other litigation,
assets will become impaired in respect of which we
and be written off at do not have insurance
some time in the future. coverage, or if an insurer's
denial of coverage is
Inherent variability ultimately upheld, could
of biologics manufacturing require us to make significant
increases the risk of provisions relating to
write-offs of these product legal proceedings and
batches. Due to the value could materially adversely
of the materials used, affect our financial
the carrying amount of condition or results
biological products is of operations.
much higher than that
of small molecule products. For more information,
As we continue to grow please see the Adverse
our biologics business, outcome of litigation
we also increase the and/or governmental investigations
risk of potential impairment risk on page 223.
charges.
The resolution of tax
In recent years, the disputes regarding the
costs associated with profits to be taxed in
product liability litigation individual territories
have increased the cost can result in a reallocation
of, and narrowed the of profits between jurisdictions
coverage afforded by, and an increase or decrease
pharmaceutical companies' in related tax costs,
product liability insurance. and has the potential
To contain insurance to affect our cash flows,
costs, we have continued EPS and post-tax earnings.
to adjust our coverage Claims, regardless of
profile, accepting a their merits or their
greater degree of uninsured outcome, are costly,
exposure. The Company divert management attention
has not held any material and may adversely affect
product liability insurance our reputation.
since February 2006.
In addition, where claims If any double tax treaties
are made under insurance should be withdrawn or
policies, insurers may amended, especially in
reserve the right to a territory where a member
deny coverage on various of the AstraZeneca Group
grounds. For example, is involved in a taxation
product liability litigation dispute with a tax authority
cases relating to Crestor in relation to cross-border
and Nexium in the US transactions, such withdrawal
are not covered by third or amendment could materially
party product liability adversely affect our
insurance. See Note 28 financial condition or
to the Financial Statements results of operations,
from page 185 for details. as could a negative outcome
of a tax dispute or a
The integrated nature failure by tax authorities
of our worldwide operations to agree through competent
can produce conflicting authority proceedings.
claims from revenue authorities See the Financial risk
as to the profits to management policies section
be taxed in individual of the Financial Review
countries. The majority on page 76 for tax risk
of the jurisdictions management policies and
in which we operate have Note 28 to the Financial
double tax treaties with Statements from page
other foreign jurisdictions, 185 for details of current
which provide a framework tax disputes.
for mitigating the incidence
of double taxation on Changes in tax regimes
our revenues and capital could result in a material
gains. impact on the Company's
cash tax liabilities
The Company's worldwide and tax charge, resulting
operations are taxed in either an increase
under laws in the jurisdictions or a reduction in financial
in which they operate. results depending upon
International standards the nature of the change.
governing the global We represent views to
tax environment regularly the OECD, governments
change. The Organisation and tax authorities through
for Economic Co-operation public consultations
and Development (OECD) to ensure international
has proposed a number institutions and governments
of changes under the understand the business
Base Erosion and Profit implications of proposed
Shifting (BEPS) Action law changes. Specific
Plans. OECD BEPS recommendations
that we expect to impact
Our defined benefit pension the Company include changes
obligations are largely to patent box regimes,
backed by assets invested restrictions of interest
across the broad investment deductibility and revised
market. Our most significant transfer pricing guidelines.
obligations relate to
defined benefit pension Sustained falls in asset
funds in the UK, Sweden values could reduce pension
and the US. The largest fund solvency levels,
obligation is in the which may result in requirements
UK. for additional cash,
restricting the cash
available for our business.
Changes to funding regulations
for defined benefit pensions
may also result in a
requirement for additional
cash contributions by
the Company. If the present
value of the liabilities
increase due to a sustained
low interest rate environment,
an increase in expectations
of future inflation,
or an improvement in
member longevity (above
that already assumed),
this could also reduce
pension fund solvency
ratios. The likely increase
in the IAS 19 accounting
deficit
generated by any of these
factors may cause the
credit rating agencies
to review our credit
rating, with the potential
to negatively affect
our ability to raise
debt and the price of
new debt issuances. See
Note 20 to the Financial
Statements from page
165 for further details
of the Group's pension
obligations.
--------------------------------------- ------------------------------------
Failure in financial control or the occurrence
of fraud
-----------------------------------------------------------------------------
Effective internal controls Significant resources
are necessary for us may be required to remediate
to provide reliable financial any lapse or deficiency
reports and are designed in internal controls.
to prevent and detect
fraud. Lapses in controls Any such deficiency may
and procedures could also trigger investigations
undermine the ability by a number of organisations,
to prevent fraud or provide for example, the SEC,
accurate disclosure of the DOJ or the SFO and
financial information may result in fines being
on a timely basis. Testing levied against the Company
of our internal controls or individual directors.
can provide only reasonable
assurance with respect Serious fraud may lead
to the preparation and to potential prosecution
fair presentation of or even imprisonment
financial statements of senior management.
and may not prevent or
detect misstatements
or fraud.
--------------------------------------- ------------------------------------
APPIX B
This statement relates to and is extracted from the Annual Report. It is repeated here solely for the purpose of complying with DTR 6.3.5. It is not connected to the information presented in this announcement or in the Company's fourth quarter and full year results 2016 announcement that was published on 2 February 2017.
Directors' responsibility statement pursuant to DTR 4
The Directors confirm that to the best of our knowledge:
-- The Financial Statements, 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 Company and the undertakings included in the consolidation taken as a whole.
-- The Directors' Report includes a fair review of the development and performance of the business and the position of the issuer and the undertakings included in the consolidation taken as a whole, together with a description of the principal risks and uncertainties that they face.
On behalf of the Board of Directors on 2 February 2017
Pascal Soriot
Director
APPIX C
Related party transactions
The Group had no material related party transactions which might reasonably be expected to influence decisions made by the users of these Financial Statements.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of Autoimmunity, Neuroscience and Infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.
Media Enquiries Esra Erkal-Paler UK/Global +44 203 749 5638 Vanessa Rhodes UK/Global +44 203 749 5736 Karen Birmingham UK/Global +44 203 749 5634 Rob Skelding UK/Global +44 203 749 5821 Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677 Investor Relations Thomas Kudsk Larsen +44 203 749 5712 Craig Marks Finance, Fixed Income, M&A +44 7881 615 764 Henry Wheeler Oncology +44 203 749 5797 Mitchell Chan Oncology +1 240 477 3771 Lindsey Trickett Cardiovascular & Metabolic Diseases +1 240 543 7970 Nick Stone Respiratory +44 203 749 5716 Christer Gruvris Autoimmunity, Neuroscience & Infection +44 203 749 5711 US toll free +1 866 381 7277
This information is provided by RNS
The company news service from the London Stock Exchange
END
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