|
Risk
category and Principal Risks
|
Context/potential
impact
|
Management
actions
|
|
Product pipeline and intellectual property
|
||
|
Delivery
of pipeline and new products
|
The
development of any pharmaceutical product candidate is a complex,
risky and lengthy process involving significant financial, R&D
and other resources. A project may fail or be delayed at any stage
of the process due to a number of factors, which could reduce our
long-term growth, revenue and profit.
|
>
Prioritise and accelerate our pipeline
>
Strengthen pipeline through acquisitions, licensing and
collaborations
>
Focus on innovative science in three main therapy
areas
|
|
Meet
quality, regulatory and ethical drug approval and disclosure
requirements
|
Our
pharmaceutical products and commercialisation
processes
are subject to extensive regulation. Delays in regulatory reviews
and approvals impact patients and market access, and can materially
affect our business or financial results.
|
>
Quality management systems incorporating monitoring, training and
assurance activities
>
Collaborating with regulatory bodies and advocacy groups to monitor
and respond to changes in the regulatory environment, including
revised process, timelines and guidance
|
|
Secure
and protect product IP
|
Discovering
and developing medicines requires a significant investment of
resources. For this to be a viable investment, new medicines must
be safeguarded from being copied for a reasonable amount of time.
If we are not successful in obtaining, maintaining, defending or
enforcing our IP rights, our revenues could be materially adversely
affected.
Third
parties may allege infringement of their IP, and may seek
injunctions and/or damages, which, if ultimately awarded, could
adversely impact our commercial and financial
performance.
|
>
Active management of IP rights and IP litigation
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|
Commercialisation
|
||
|
Externally
driven demand, pricing, access and competitive
pressures
|
Operating
in over 100 countries, we are subject to political, socioeconomic
and financial factors both globally and in individual countries.
There can be additional pressure from governments and other
healthcare payers on medicine prices and sales in response to
recessionary pressures, reducing our revenue, profits and cash
flow.
|
>
Focus on Growth Platforms
>
Demonstrating value of medicines/health economics
>
Global footprint
>
Diversified portfolio
|
|
Quality
and execution of commercial strategies
|
If
commercialisation of a product does not succeed as anticipated, or
its rate of sales growth is slower than anticipated, there is a
risk that we may not be able to fully recoup the costs in launching
it.
|
>
Focus on Growth Platforms
>
Accelerate and risk share through business development and
strategic collaborations and alliances
|
|
Supply chain and business execution
|
||
|
Maintain
supply of compliant, quality product
|
Delays
or interruptions in supply can lead to recalls,
product
shortages, regulatory action, reputational harm and lost
sales.
|
>
Establishment of new manufacturing facilities, creating capacity
and technical capability to support new product launches,
particularly biologics
>
Business continuity and resilience initiatives, disaster and data
recovery and emergency response plans
>
Contingency plans including dual sourcing, multiple suppliers and
stock levels
>
Quality management systems
|
|
Information
technology, data security and privacy
|
Significant
disruption to our IT systems, cybersecurity incidents including
breaches of data security, or data privacy failure, could harm our
reputation and materially affect our financial condition or results
of operations. This could lead to regulatory penalties or
non-compliance with laws and regulations.
|
>
Cybersecurity framework and dashboard
>
Privacy office oversees compliance with data privacy
legislation
>
Disaster and data recovery plans
>
Strategies to secure critical systems and processes
>
Regular cybersecurity and privacy training for
employees
|
|
Attract,
develop, engage and retain talented and capable employees at all
levels
|
Failure
to attract and retain highly skilled personnel may weaken our
succession plans for critical positions in the medium term.
Employee uncertainty as a result of, for example, Brexit or
organisational change may result in a lower level of employee
engagement which could impact productivity and turnover. Both could
adversely affect the achievement of our strategic
objectives.
|
>
Targeted recruitment and retention strategies deployed
>
Identification and active support of staff potentially impacted by
Brexit
>
Development of our employees
>
Evolve our culture
>
Focus on simplification
|
|
Legal, regulatory and compliance
|
||
|
Safety
and efficacy of marketed products
|
Patient
safety is very important to us and we strive to minimise the risks
and maximise the benefits of our medicines. Failure to do this
could adversely impact our reputation, our business and the results
of operations, and could lead to product liability
claims.
|
>
Robust processes and systems in place to manage patient safety and
efficacy trends as well as externally reported risks through
regulatory agencies and other parties. This includes a
comprehensive pharmacovigilance programme supplemented by close
monitoring and review of adverse events
|
|
Defence
of product, pricing and practices litigation
|
Investigations
or legal proceedings could be costly, divert management attention
or damage our reputation and demand for our products. Unfavourable
resolutions could subject us to criminal liability, fines,
penalties or other monetary or non-monetary remedies, adversely
affecting our financial results.
|
>
Combined internal and external counsel management
|
|
Meet
regulatory and ethical expectations on commercial practices,
including bribery and corruption, and scientific
exchanges
|
Any
failure to comply with applicable laws, rules and regulations,
including bribery and corruption legislation, may result in civil
and/or criminal legal proceedings and/or regulatory sanctions,
fines or penalties, impacting financial results.
|
>
Strong ethical and compliance culture
>
Established compliance framework in place including annual Code of
Ethics training for all employees
>
Focus on due diligence and oversight of third-party
engagements
|
|
Economic and financial
|
||
|
Achieve
strategic plans and meet targets and expectations
|
Failure
to successfully implement our business strategy may frustrate the
achievement of our financial or other targets or expectations. This
failure could, in turn, damage our reputation and materially affect
our business, financial position or results of
operations.
|
>
Focus on Growth Platforms and innovative science in three main
therapy areas
>
Strengthen pipeline through acquisitions, licensing and
collaborations
>
Appropriate capital structure and balance sheet
>
Portfolio-driven decision making process governed by senior
executive-led committees
|
|
Media
Relations
|
|
|
|
Gonzalo
Viña
|
UK/Global
|
+44 203
749 5916
|
|
Rob
Skelding
|
UK/Global
|
+44 203
749 5821
|
|
Matt
Kent
|
UK/Global
|
+44 203
749 5906
|
|
Jennifer
Hursit
|
UK/Global
|
+44
203 749 5762
|
|
Christina Malmberg
Hägerstrand
|
Sweden
|
+46 8 552 53 106
|
|
Michele
Meixell
|
US
|
+1 302
885 2677
|
|
|
|
|
|
Investor
Relations
|
|
|
|
Thomas
Kudsk Larsen
|
|
+44 203 749 5712
|
|
Henry
Wheeler
|
Oncology
|
+44 203
749 5797
|
|
Christer
Gruvris
|
BioPharma - Cardiovascular; Metabolism
|
+44 203
749 5711
|
|
Nick
Stone
|
BioPharma
- Respiratory; Renal
|
+44 203
749 5716
|
|
Josie
Afolabi
|
Other
|
+44 203
749 5631
|
|
Craig
Marks
|
Finance;
Fixed Income
|
+44
7881 615 764
|
|
Jennifer
Kretzmann
|
Retail
Investors; Corporate Access
|
+44 203
749 5824
|
|
US
toll-free
|
|
+1 866
381 72 77
|
|
|
|
|
|
|
AstraZeneca
PLC
|
|
|
By: /s/
Adrian Kemp
|
|
|
Name:
Adrian Kemp
|
|
|
Title:
Company Secretary
|