AstraZeneca PLC — Foreign Filer Report 2021

Feb 16, 2021

6-K 1 a1125p.htm ANNUAL FINANCIAL REPORT Document created using Blueprint(R) - powered by Issuer Direct - www.issuerdirect.com Copyright 2021 Issuer Direct Corporation a1125p

FORM 6-K

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Report of Foreign Issuer

Pursuant to Rule 13a-16 or 15d-16 of

the Securities Exchange Act of 1934

For the month of February 2021

Commission File Number: 001-11960

AstraZeneca PLC

1 Francis Crick Avenue

Cambridge Biomedical Campus

Cambridge CB2 0AA

United Kingdom

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F X Form 40-F __

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes __ No X

If “Yes” is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b): 82-_______

AstraZeneca PLC

INDEX TO EXHIBITS

1.

Annual Financial Report

15 February 2021 11:00 GMT

Annual Financial Report

AstraZeneca PLC (the Company) announced today the publication of its Annual Report and Form 20-F Information 2020 (the Annual Report).

A copy of the Annual Report will be submitted to the National Storage Mechanism and will shortly be available for inspection at https://data.fca.org.uk/#/nsm/nationalstoragemechanism .

The Annual Report is also available on the Company's website at: www. astrazeneca.com/annualreport2020 .

The Annual Report will be dispatched to shareholders in due course.

The Company's Annual General Meeting (AGM) will take place on 30 April 2021. The Notice of AGM and Shareholders' Circular will be published and distributed to shareholders in due course.

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

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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 2020 announcement, issued on 11 February 2021, which contained a condensed set of financial statements and an Operating and financial review, and which can be found at www.astrazeneca.com/investor-relations/results-and-presentations.html . 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.

APPENDIX A

The Board has carried out a robust assessment of the Principal and Emerging risks facing the Group. The table overleaf provides insight into the ongoing Principal Risks, outlining why effective management of these risks is important and relevant to the business, how we are managing them and which risks are rising, falling or have remained static during the past 12 months. The procedures in place to identify emerging risks are explained below.

Managing risk

Our approach to risk management is designed to encourage clear decision making on which risks we take and how we manage these risks. Fundamental to this process is a sound understanding of every risk's potential strategic, commercial, financial, compliance, legal and reputational implications.

We work to ensure that we have effective risk management processes in place to support the delivery of our strategic priorities. This enables us to meet the expectations of our stakeholders and upholds our Values. The Board believes that existing processes provide it with adequate information on the risks and uncertainties we face. Further information

can be found in Risk from page 254, which includes a description of circumstances under which Principal and other risks and uncertainties might arise in the course of our business and their potential impact.

| Risk
category and Principal Risks | Context/potential
impact | Management
actions |
| --- | --- | --- |
| Product pipeline and intellectual property | | |
| Failure
or delay in the delivery of our pipeline or launch of new
medicines | 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. |
| Failure
to meet regulatory or ethical requirements for medicine development
or approval | 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. |
| Failure
to obtain, defend and enforce effective IP protection or IP
challenges by third parties | 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, and face competition from generic or
biosimilar products, 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. |
| Commercialisation | | |
| Pricing,
affordability, access and competitive pressures | Operating
in more than 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, which may lead to a
reduction in our revenue, profits and cash flow. | > Focus
on sales platforms. > Demonstrating
value of medicines/ health economics. > Global
footprint. > Diversified
portfolio. |
| Failure
or delays in the quality or execution of the Group's 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 related launch
costs. | > Focus
on sales platforms. > Accelerate
execution of plans and risk share through business development and
strategic collaborations and alliances. |
| Supply chain and business execution | | |
| Failure
to maintain supply of compliant, quality medicines | Delays
or interruptions in supply can lead to recalls, product shortages,
regulatory action, reputational harm and lost sales
revenue. | > Establishment
of new manufacturing facilities, creating capacity and technical
capability to support new product launches. > Contingency
plans including dual sourcing, multiple suppliers, and close
monitoring and maintenance of stock levels. > Business
continuity and resilience initiatives, disaster and data recovery
and emergency response plans. > Quality
management systems. |
| Failure
in information technology or cybersecurity | Significant
disruption to our IT systems or cybersecurity incidents, including
breaches of data security, 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. > Disaster
and data recovery plans. > Strategies
to secure critical systems and processes. > Regular
cybersecurity and privacy training for employees. |
| Failure
to attract, develop, engage and retain a diverse, talented and
capable workforce | 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. |
| Legal, regulatory and compliance | | |
| Safety
and efficacy of marketed medicines is questioned | 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. |
| Adverse
outcome of litigation and/or governmental
investigations | Investigations
or legal proceedings could be costly, divert management attention
and/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. |
| Failure
to meet regulatory and ethical expectations on commercial
practices, including anti-bribery and anti-corruption, and
scientific exchanges | Any
failure to comply with applicable laws, rules and regulations,
including anti-bribery and anti-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 including annual Code of Ethics training for
all employees. > Focus
on due diligence and oversight of third-party
engagements. |
| Economic and financial | | |
| Failure
to achieve strategic plans or meet targets or
expectations | Failure
to implement successfully 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 sales 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. |

APPENDIX 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 2020 announcement that was published on 11 February 2021.

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 11 February 2021

Pascal Soriot

Director

APPENDIX 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

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) 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 therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @ AstraZeneca .

Contacts

For details on how to contact the Investor Relations Team, please click here . For Media contacts, click here .

Adrian Kemp

Company Secretary

AstraZeneca PLC

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

AstraZeneca PLC

Date: 15 February 2021

| By: /s/
Adrian Kemp |
| --- |
| Name:
Adrian Kemp |
| Title:
Company Secretary |

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