UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
OR
For the fiscal year ended
OR
OR
Date of event requiring this shell company report…………………………………..
For the transition period from ___________________ to _______________________
Commission file number:
(Exact name of Registrant as specified in its charter) |
|
(Jurisdiction of incorporation or organization) |
|
(Address of principal executive offices) |
|
Telephone: + Facsimile number: +44 1223 352 858 |
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person) |
Securities registered or to be registered pursuant to Section 12(b) of the Act:
Title of each class |
| Trading symbol(s) |
| Name of each exchange on which registered |
|
| |||
Ordinary Shares of 25¢ each |
|
|
| The Nasdaq Stock Market LLC * |
|
| |||
|
| |||
|
| |||
|
| |||
|
| |||
|
| |||
|
| |||
|
| |||
|
| |||
|
| |||
|
| |||
|
| |||
* Not for trading, but only in connection with the registration of American Depositary Shares representing such Ordinary Shares pursuant to the requirements of the Securities and Exchange Commission.
Securities registered or to be registered pursuant to Section 12(g) of the Act:
None |
(Title of Class) |
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:
None |
(Title of Class) |
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.
The number of outstanding shares of each class of stock of AstraZeneca PLC as of December 31, 2021 was:
Title of Class |
| Number of Shares Outstanding |
|
Ordinary Shares of 25¢ each: |
|
| |
Redeemable Preference Shares of £1 each: |
|
|
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
Yes ☐
Note — Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):
| Accelerated Filer ☐ |
| Non-accelerated Filer ☐ | |
|
|
|
| Emerging growth company ☐ |
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act.
† The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.
☒
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
U.S. GAAP | ☐ | ☒ | Other ☐ |
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.
☐ Item 17 ☐ Item 18
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No
(APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PAST FIVE YEARS)
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Section 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.
Yes ☐ No ☐
Pursuant to Rule 12b-23(a) of the Securities Exchange Act of 1934, as amended, the information for the 2021 Form 20-F of AstraZeneca PLC (the “Company”) set out below is being incorporated by reference from AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated and submitted on February 22, 2022.
References below to major headings include all information under such major headings, including subheadings, unless such reference is a reference to a subheading, in which case such reference includes only the information contained under such subheading. Unless the context otherwise requires, “AstraZeneca” or “Group” refers to the Company and its consolidated entities. Other information contained within AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F, including graphs and tabular data, is not included in this Form 20-F unless specifically identified below. Photographs are also not included.
In addition to the information set out below, the information (including tabular data) set forth under the headings “Use of terms” on the inside front cover, “Strategic Report—Financial Review—Measuring performance” on page 54, and the tables on pages 55 and 56, “Additional Information—Trade Marks” on page 223, “—Glossary” on pages 224 to 227 and “—Important information for readers of this Annual Report—Cautionary statement regarding forward-looking statements”, “—Inclusion of Reported performance, Core financial measures and constant exchange rate growth rates”, “—Statements of competitive position, growth rates and sales”, “—AstraZeneca websites”, “—External/third-party websites” and “—Figures” on page 228, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference. References herein to AstraZeneca websites, including where a link is provided, are textual references only and information on or accessible through such websites does not form part of and is not incorporated into this Form 20-F dated February 22, 2022. Reference to “audited” information (including graphs and tabular data) set forth under the heading “Corporate Governance—Directors’ Remuneration Report” refers to procedures performed by the Company’s external auditor in accordance with International Standards on Auditing (UK) (‘ISAs (UK)’) and applicable law and does not form part of the “Report of Independent Registered Public Accounting Firm” in Item 18 herein.
PART 1
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Not applicable.
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE
Not applicable.
ITEM 3. KEY INFORMATION
A. Selected Financial Data
Reserved.
B. Capitalization and Indebtedness
Not applicable.
C. Reason for the Offer and Use of Proceeds
Not applicable.
D. Risk Factors
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 “Risk Overview—Principal Risks” detailed from page 50 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022, which are included below along with the other risks that we face. We believe that the forward-looking statements about AstraZeneca in this Form 20-F dated February 22, 2022, identified by words such as ‘anticipates’, ‘believes’, ‘expects’ and ‘intends’, and that include, among other things, future prospects in the “Financial Review” from page 52 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022, 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
3
different from our expectations. Therefore, other risks, unknown or not currently considered material, could have a material adverse effect on our financial condition, results of operations and/or reputation.
Product pipeline risks
Failure or delay in the delivery of our pipeline or launch of new medicines
Our continued success depends on the development and successful launch of innovative new drugs. The development of pharmaceutical product candidates is a complex, risky and lengthy process involving significant resources. A project may fail at any stage of the process due to various factors, including: failure to obtain the required regulatory or marketing approvals, unfavourable clinical efficacy data, safety concerns, failure to demonstrate adequate cost-effective benefits to regulatory authorities and/or payers, and the emergence of competing products. More details of projects that have suffered setbacks or failures during 2021, can be found in the “Strategic Report—Disease Area Review” on pages 16 to 29 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022.
Launch activities may be delayed by a number of factors, including: adverse findings in pre-clinical or clinical studies, regulatory demands, price negotiation, large-scale natural disasters or global pandemics, competitor activity and technology transfer.
In addition to developing products in-house, we continue to expand our portfolio through licensing arrangements and strategic collaborations which may not ultimately be successful.
Impact
Failure or delay in development of new product candidates could damage the reputation of our R&D capabilities, and materially adversely affect our future business and results of operations. See also “Failure to achieve strategic plans or meet targets or expectations” below.
Delays to launches can lead to excess expenses in the manufacture of pre-launch product stocks, marketing materials and sales force training. For the launch of products that are seasonal in nature, delays in regulatory approvals or manufacturing may delay launch to the next season which, in turn, may significantly reduce the return on costs incurred in preparing for the launch for that season. Furthermore, in immuno-oncology in particular, speed to market is critical given the large number of clinical trials being conducted by competitors. Delay of launch can also erode the term of patent exclusivity.
Competition from other pharmaceutical companies means that we may have to pay a significant premium over book or market values for our acquisitions. Failure to complete collaborative projects in a timely, cost-effective manner may limit our ability to access a greater portfolio of products, IP, technology and shared expertise. In many cases we make milestone payments in advance of the commercialisation of the products, with no assurance of recouping costs.
Failure to meet regulatory or ethical requirements for medicine development or approval
We are subject to laws and regulations that control our ability to market our pharmaceutical products. Our development programmes must meet many standards in order to prove that our products are safe, effective and of high quality. These standards vary by country and region. Health authorities, such as the FDA in the US and the EMA in the EU, can refuse to grant approval for our products, or they may require us to conduct additional clinical trials or scientific testing for our products, or provide additional data before they will approve our products for marketing. The EU Clinical Trials Regulation, which is intended to create a favourable environment for conducting clinical trials while maintaining high standards for patient safety, came into application on 31 January 2022. EMA expects pharmaceutical companies to submit product data in Identification of Medicinal Products (IDMP) format, presenting a significant challenge to the industry as the requirements are complex.
Many factors influence a health authority’s decision to approve or reject a marketing application for a pharmaceutical product. These include: advances in science and technology; new laws, regulations and policies; different standards for evaluating safety and effectiveness by health authorities; and input from the general public and public interest groups.
Following approval, a health authority may require us to conduct additional clinical trials or scientific testing to address concerns raised after our products have been used by patients in the marketplace.
Impact
Delays in regulatory approvals could impact our ability to market our products and may adversely affect our revenue. In addition, post-approval requirements, including additional clinical trials, could result in increased costs. We seek to manage these risks, but policymaking by governments and health authorities is unpredictable at times, and unforeseen circumstances, such as public health emergencies, may strain health authority resources. These factors may delay the approval of our products.
4
New data may impact a product’s approval status or lead to labelling changes that may limit the use of a product.
While we support transparency efforts to make clinical trial data more publicly accessible, inappropriate or incorrect independent analyses may damage a product’s integrity and our Company’s reputation.
Commercialisation risks
Failures or delays in the quality or execution of the Group’s commercial strategies
The successful launch of a new pharmaceutical product involves substantial investment in sales and marketing activities, launch stocks and other areas. We may ultimately be unable to achieve commercial success for various reasons, including: difficulties in manufacturing sufficient quantities of the product candidate for development or commercialisation in a timely manner; the impact of price control measures imposed by governments and healthcare authorities; the outcome of negotiations with third-party payers; erosion of IP rights, including infringement by third parties; failure to show a differentiated product profile and changes in prescribing habits.
The ability to successfully carry out business in emerging markets can be more challenging than in established markets. Such challenges may include; volatility in economic or political climates; inadequate protection against crime (including counterfeiting, corruption and fraud) and inadvertent breaches of local and international law.
The commercialisation of biologics and rare disease therapies is often more complex than for small molecule pharmaceutical products, primarily due to differences in the mode of administration, technical aspects of the product, and rapidly changing distribution and reimbursement environments..
Impact
Failure to execute our commercial strategies or failure to achieve the level of sales anticipated to recoup launch and development investment, could materially adversely impact our business or results of operations.
Failure to leverage potential opportunities or appropriately manage risks in emerging markets, may materially adversely affect our reputation, business or results of operations.
Failure to effectively commercialise biologics and rare disease therapies could prevent us realising the full value of a significant proportion of our pipeline, as well as result in delays to launch and material write-offs.
Pricing, affordability, access and competitive pressures
Operating in more than 100 countries, we are subject to political, socio-economic and financial factors around the world. A sustained global economic downturn may adversely impact our business. Global pressures to reduce healthcare spending mean many of our key markets experience the implementation of various controls, reimbursement mechanisms or cost-containment measures for pharmaceutical products, including:
> drug pricing system reforms
> restrictive reimbursement policies
> payer consolidation in the US
> price transparency
> reference pricing
> expedited approval of generic drugs and introduction of policies which encourage generic utilisation
> cost transparency
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 the Impact section.
Geopolitical tensions and the escalation of trade disputes may lead to sanctions, such as the unilateral imposition of tariffs, or non-tariff barriers. Price control measures could have a relatively high impact on our Rare Disease portfolio, given higher annual prices of orphan medicines and small patient populations.
Impact
Deterioration of, or lack of improvement in, socio-economic conditions, could adversely affect supply and/or distribution in affected countries, and the ability or willingness of customers to purchase our medicines, putting pressure on price and/or volumes. This could adversely affect our business or results of operations – for example, those health systems most severely impacted by downturn may seek alternative ways to settle their debts at a discount. Other customers may cease to trade, which may result in losses from writing off debts, or a reduction in demand for products.
5
A downturn may exacerbate pressure from governments and other healthcare payers on medicine prices and volumes of sales, and may cause a slowdown in growth, or sales decline, in some markets. For example, in the US, any future changes to the Affordable Care Act (ACA), or any significant spending reductions or cost controls affecting Medicare, Medicaid or other publicly funded or subsidised health programmes, could adversely affect our business and financial results.
Additionally, in the US, consolidation and integration of drug distributors, retail pharmacy chains, private insurers, managed care organisations and other purchasing organisations, may continue to have an effect on pharmaceutical manufacturers, including AstraZeneca.
Another example of commercial pressure is pricing control in China; 119 medicines, including AstraZeneca medicines, were added to the National Reimbursement Drug List (NRDL) in March 2021, with an average price reduction of 51%. Volume-based procurement (VBP) was also expanded in 2021, placing downward pressure on the price of medicines that have lost exclusivity and are facing local competition from Generic Quality Consistency Evaluation (GQCE)-validated products.
In Europe, governments continue to implement and expand price control measures for medicines. The EU has also committed to introducing a joint health technology assessment (HTA) review, which may delay reimbursement decisions.
In other markets, there has been a trend towards rigorous and consistent application of pricing regulations, including reference pricing and group purchasing.
The implementation of tariffs or non-tariff barriers may increase the cost to supply medicines, or reduce the volumes sold in markets, adversely impacting our financial results.
Supply chain and business execution risks
Failure to maintain supply of compliant, quality medicines
Manufacturing and supply difficulties, delays and interruptions, including:
> Product demand significantly in excess of what has been forecasted, or supply chain disruptions (e.g. due to natural disasters, COVID-19), may lead to supply shortages.
> Delays in construction of new facilities or the expansion of existing facilities to support future demand for our products, including new types of medicine.
> The inability to supply products due to a product quality failure (including a failure to manufacture in accordance with Good Manufacturing Practices (GMP) or other regulations) or regulatory compliance action, such as licence withdrawal, product recall or product seizure.
> Reliance on third-party suppliers for active ingredients, packaging components etc.
Impact
Difficulties with manufacturing and supply, forecasting, distribution or third-party suppliers, may result in product shortages, which may lead to lost product sales and materially adversely affect our reputation and revenues. Even slight variations in components or any part of the manufacturing process may lead to a product that is non-compliant and does not meet quality standards. This could lead to recalls, spoilage, product shortage, regulatory action and/or reputational harm. In the event of insolvency of third-party suppliers, it would be difficult to substitute in a timely manner or at all.
Illegal trade in the Group’s medicines
The illegal trade of our pharmaceutical products, including counterfeiting, tampering, theft and illegal diversion (where products are found in a market where we did not send them and where they are not approved to be sold) may lead to a loss of public confidence in the integrity of our medicines.
Impact
Illegal trade could materially adversely affect our reputation, financial performance, and pose a direct risk to patient safety. In addition, concern about this issue may cause some patients to stop taking their medicines, with consequent risks to their health.
If we are found liable for breaches in our supply chain, authorities may take action, financial or otherwise, that could restrict the distribution of our products.
6
Reliance on third-party goods and services
We spend approximately $22 billion each year with trade suppliers. The spend supports the length of our value chain from discovery to manufacture and commercialisation of our medicines.
Many of our business-critical operations, including certain R&D processes, IT systems, HR, finance, tax and accounting services are outsourced to third-party providers. We are therefore heavily reliant on these third parties, not just to deliver timely and high-quality goods and services, but also to comply with applicable laws and regulations and adhere to our ethical business expectations of third-party providers.
Impact
The failure of suppliers to deliver timely goods and services, and to the required level of quality, or the failure of suppliers to cooperate with each other, could materially adversely affect our financial condition or results of operations. Any breach of security, whether physical, cyber or data related, or failure of these third parties to operate in a way that is consistent with laws or regulations, may lead to regulatory penalties, materially affect the results of operations and adversely impact our reputation. Failure to successfully manage either the integration of outsourced services or the transition process of insourcing services from third parties may lead to business disruption..
Failure in information technology or cybersecurity
We are dependent on effective IT systems to support critical business functions. They provide an essential means of safeguarding and communicating data, including critical or strictly confidential information, the confidentiality and integrity of which we rely upon. We must ensure personal data that our third parties manage is protected and complies with increasingly stringent global privacy laws. Examples of strictly confidential information that we hold includes clinical trial records, personal information, intellectual property, R&D data, and compliance information. The size and complexity of our IT systems, cloud utilisation, and third-party vendors we engage continue to increase significantly. As a result, such systems are potentially vulnerable to service interruptions and security breaches, from attacks by malicious third parties or intentional or inadvertent actions by our employees or vendors. Significant changes in the business footprint or in the implementation of the IT strategy could lead to a temporary loss of capability.
We increasingly use the internet, digital content, social media, mobile applications, the Internet of Things (IoT), artificial intelligence, and other forms of new technology to process our data and communicate internally and externally.
Privacy legislation in various jurisdictions includes obligations to report data protection breaches, whether intentional or inadvertent, to regulators and affected individuals within expedited timeframes.
We and our vendors could be susceptible to third party or internal attacks on our information security systems. Such attacks are of ever-increasing levels of sophistication and are made by groups and individuals with a wide range of motives and expertise, including organised criminal groups, ‘hacktivists’, nation states, employees and others. Occasionally we experience intrusions, including as a result of computer-related malware.
Impact
Any significant disruption to these IT systems (including breaches of data security or cybersecurity, failure to integrate new and existing IT systems) or failure to comply with additional requirements under applicable laws, could harm our reputation and materially adversely affect our financial condition or results of operations. While we invest heavily in the protection of our data and IT, we may be unable to prevent breakdowns or breaches which could result in disclosure of confidential information, damage to our reputation, regulatory penalties or sanctions, and financial loss.The inability to back up and restore data effectively could lead to permanent loss of data that could in turn result in non-compliance with applicable laws and regulations, and otherwise harm our business.
The accessibility and instantaneous nature of interactions with such media may exacerbate the risk of unauthorised data loss from AstraZeneca. This could lead to the unauthorised or unintentional public disclosure of confidential information which may damage our reputation, adversely affect our business or results of operations, and expose us to legal risks and/or additional legal obligations. Similarly, the involuntary public disclosure of commercially sensitive information, could adversely affect our business or results of operations. In addition, negative posts, or comments about us (or, for example, the safety of our products) on social media websites or other digital channels, could harm our reputation, brand image or goodwill.
Expedited reporting, often before the nature and impact of a data breach can be fully understood, could cause reputational damage and a loss of public trust that may be disproportionate to the extent of the breach.
Although we maintain cybersecurity insurance, there can be no guarantee that our insurance coverage limits will protect against any future claim or that such insurance proceeds will be paid to us in a timely manner.
7
Failure of critical processes
Unexpected events and/or events beyond our control could result in the failure of critical processes within the Company or at third parties on whom we are reliant. The business faces threats to business continuity from many directions. Examples of material threats include:
> Disruption to our business or the global markets if there is instability in a particular geographic region, including as a result of war, terrorism, pandemics, armed conflicts, riots, unstable governments, civil insurrection or social unrest.
> Natural disasters in areas of the world prone to extreme weather events, which may increase in frequency or severity as a result of climate change, and such phenomena as earthquakes.
> Cyber threats similar to those detailed in the “failure in information technology or cybersecurity” section above.
Impact
Crystallisation of such material threats may heighten certain other risks, such as those relating to the delivery of the pipeline or launch of new medicines or the manufacture and supply of medicines, and may lead to loss of revenue and have an adverse impact on our financial results.
Failure to collect and manage data in line with legal and regulatory requirements and strategic objectives
AstraZeneca is obliged to meet legal, regulatory and ethical requirements when it collects, shares and utilises personal information and is required to operate a privacy framework, deploying people, processes and technology to manage and mitigate privacy risks. The COVID-19 pandemic has exacerbated privacy risks, changing practices relating to the collection and sharing of sensitive health data, including our employees’ health data, and accelerated third-party due diligence of COVID-19 related suppliers.
Evolving third-party relationships beyond the traditional vendor/supplier model and the increased use of digital solutions and applications represents privacy challenges. In addition, there is increasing regulatory interest in emerging technologies, including a move towards regulations relating to the utilisation of Artificial Intelligence (AI) and data other than personal data. This will require appropriate updates to AstraZeneca’s approach and capabilities in these areas.
We continue to see regulatory developments that impact the ability for personal data to be shared freely across international borders. Recent examples include data localisation requirements in China’s new personal information law, alongside new EU regulatory guidance further limiting the ability to transfer personal data from the EU to the rest of the world.
Impact
Failure to demonstrate how AstraZeneca meets these obligations could cause reputational damage, significant regulatory sanctions, reduced ability to utilise personal data for scientific and business purposes and prevent access to wider industry data-sharing initiatives. Given the evolving external and internal data environment it is important that AstraZeneca ensures that there is a consistent level of engagement of senior data ownership and stewardship across the different business areas, aligned to the data risk profile.
Partnerships with entities such as smaller biotech companies and start-ups in hubs and emerging markets, potentially with less mature privacy regulations and varying ethical standards, may impact our ability to demonstrate compliance with core privacy requirements. In addition, greater reliance on third-parties means less direct oversight of day-to-day conduct and compliance, with a need for enhanced third-party risk management.
Responding to these developments in the short term will require additional controls around personal information transfers, including the use of contractual commitments with third-parties and the deployment of additional technical measures. Long term we may see a trend to more local data storage and access including regional data centres.
Failure to attract, develop, engage and retain a diverse, talented and capable workforce
We rely heavily on recruiting and retaining talented employees with a diverse range of skills and capabilities to meet our strategic objectives. There is intense competition for well-qualified individuals, as the supply of people with certain skills or in specific geographic regions may be limited.
The successful delivery of our business objectives is dependent on high levels of engagement and commitment of the workforce, particularly as employees return to working in office locations following the pandemic. In addition, we need to effectively integrate Alexion employees to ensure they are engaged and committed to the AstraZeneca business priorities.
8
Impact
The inability to attract and retain highly-skilled personnel may weaken our succession plans for critical positions in the medium term, may materially adversely affect the implementation of our strategic objectives, and could ultimately impact our business or results of operations.
Failure to engage effectively with our employees could lead to business disruption in our day-to-day operations, reduce levels of productivity and/or increase levels of voluntary turnover, all of which could ultimately materially adversely affect our business or results of operations.
Legal, regulatory and compliance risks
Failure to meet regulatory or ethical expectations on environmental impact, including climate change
Environmental issues will become more material in the marketplace as the wider healthcare system embraces net -zero climate targets. The environmental targets and performance of our business will come under increased scrutiny by investors, governments and non-governmental organisations. Environmental considerations are starting to become embedded in the public procurement of good and services, including medicinal products and devices. Specific intermediates used to manufacture medicines, or those used as excipients or propellants, are coming under increased regulation and some may be subject to time-limited exemptions or potential phase-out. The physical impacts of climate change could impact the resilience of our business operations and supply chain.
Impact
Investors will increasingly target companies with strong Environmental, Social and Governance (ESG) performance. We continue to see an increased requirement to disclose our ESG strategy, targets and performance. This includes a requirement to quantify the impact of specific ESG issues on our business and associated mitigation plans (e.g. the impact of climate change through TCFD and CDP).
Failure to maximise the sustainability credentials of our business, products and the processes used to make our medicines could expose us to increased regulatory risk, and put us at a commercial disadvantage relative to our peers. This could adversely impact our financial results.
Failure to proactively manage the physical risks associated with climate change could impact the resilience of our operations and supply chain. This could result in supply interruptions, loss of stock and adversely impact our financial results.
Safety and efficacy of marketed medicines is questioned
Our ability to accurately assess, prior to launch, the eventual safety or efficacy of a new product once in broader clinical use can only be based on data available at that time, which is inherently limited due to relatively short periods of product testing and relatively small clinical study patient samples.
Any unforeseen safety concerns or adverse events relating to our products, or failure to comply with laws, rules and regulations relating to provision of appropriate warnings concerning the dangers and risks of our products that result in injuries, could expose us to large product liability damages claims, settlements and awards, particularly in the US. Adverse publicity relating to the safety of a product, or of other competing products, may increase the risk of product liability claims. Details of material product liability litigation matters can be found in “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments and contingent liabilities” on pages 189 to 196 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022.
Impact
Serious safety concerns or adverse events relating to our products could lead to product recalls, seizures, loss of product approvals, declining sales and interruption of supply, and could materially adversely impact patient access, our reputation and financial revenues.
Significant product liability claims could also arise which could be costly, divert management attention, or damage our reputation and demand for our products.
Unfavourable resolution of such current and similar future product liability claims could subject us to enhanced damages, consumer fraud and/or other claims, including civil and criminal governmental actions.This could require us to make significant provisions in our accounts relating to legal proceedings, and could materially adversely affect our financial condition or results of operations, particularly where such circumstances are not covered by insurance. For more information on limited third-party insurance coverage, see “Unexpected deterioration in the Group’s financial position” below.
9
Adverse outcome of litigation and/or governmental investigations
We may be subject to various legal proceedings and governmental investigations. Our many business operations are subject to a wide range of laws, rules and regulations from around the world. Any failure to comply with these applicable laws, rules and regulations may result in AstraZeneca being investigated by relevant governmental agencies and authorities and/or subject to legal proceedings brought by private citizens. Relevant authorities have wide-ranging administrative powers to deal with any failure to comply with continuing regulatory oversight, and this could affect us, whether such failure is our own or that of our contractors or external partners. In particular, the manufacturing, marketing, exportation, promotional, clinical, pharmacovigilance, and pricing practices of pharmaceutical manufacturers, as well as the manner in which manufacturers interact with regulatory agencies, purchasers, prescribers and patients, are subject to extensive regulation, litigation and governmental investigation. Moreover, such laws, rules and regulations are subject to change.
Impact
Many companies, including AstraZeneca, have been subject to legal claims asserted by federal and state governmental authorities and private payers and consumers, which have resulted in substantial expense and other significant consequences. Governmental investigations or proceedings could result in us becoming subject to civil or criminal sanctions and/or being forced to pay fines or damages. Civil litigation, particularly in the US, is inherently unpredictable and unexpectedly high awards for damages can result from an adverse result. In many cases, litigation adversaries may claim enhanced damages in extremely high amounts. Government investigations, litigations, and other legal proceedings, regardless of their outcome, could be costly, divert management attention, or damage our reputation and demand for our products. “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments and contingent liabilities” on pages 189 to 196 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022, describes the material legal proceedings in which we are currently involved. Unfavourable resolution of current and similar future proceedings against us could subject us to criminal liability, fines, penalties or other monetary or non-monetary remedies, including enhanced damages, require us to make significant provisions in our accounts relating to legal proceedings and could materially adversely affect our business or results of operations.
IP-related risks to our products
IP protection provides the foundation for continued investment in developing innovative medicines to improve patient health. However, the pharmaceutical industry is experiencing pressure from governments and other healthcare payers to impose limits on IP protections in an effort to manage healthcare costs. Additionally, policymakers are progressively leveraging regulations to expedite the approval of generic drugs and encourage generic drug utilisation. These policies may drive accelerated utilisation of generic alternatives to our products following expiry or loss of our IP rights. We also recognise increasing use of compulsory licensing in some countries in which we operate.
We are subject to numerous patent challenges relating to various products or processes and assertions of non-infringement of our patents. A loss in any of these challenges could result in loss of patent protection on the covered product, and a risk to the revenue generated by the product. We also face the risk that our products may be found to infringe patents owned or licensed by third parties and be subject to monetary damages, or compelled to cease sales of the infringing product, resulting in a potential risk to revenue.
These challenges threaten the value of our investment in pharmaceutical development. Details of material patent litigation matters can be found in “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments and contingent liabilities” on pages 189 to 196 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022.
Impact
Following expiry of our IP rights, or if we are unable to obtain, defend and enforce IP that protects our products, we may experience accelerated and intensified competition from third parties. Also, if our products are found to infringe a third-party patent, we may be subject to monetary damages or compelled to cease sales of the infringing product. These negative outcomes could have an adverse, material impact on our financial results.
Economic and financial risks
Failure to achieve strategic plans or meet targets or expectations
From time to time, we communicate our business strategy, our targets or performance expectations (for example, the expectations described in “Strategic Report—Financial review—Future prospects” on page 66 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022. All such statements are of a forward-looking nature and based on assumptions and judgements, all of which are subject to significant
10
inherent risks and uncertainties. Following the acquisition of Alexion in July 2021, we may experience difficulties in integrating geographically separated organisations, systems and facilities, and personnel with different organisational cultures.
Impact
There can be no guarantee that our financial targets or expectations will materialise. Actual results may deviate materially and adversely from any target or expectation. Any failure to successfully implement our business strategy may frustrate the achievement of our targets, which may therefore materially damage our brand, business, financial position or results of operations. Failure to effectively integrate Alexion into the Group may delay the realisation of anticipated benefits from the acquisition, incur higher than anticipated costs of integration, or result in ongoing operational inefficiencies which may adversely impact the results of operations. Furthermore, our reported results of operations may be negatively impacted from acquisition-related charges, amortisation of expenses related to intangibles, charges for the implementation of long-term assets, or previously unknown or unidentified contingent liabilities.
Failure in financial control or the occurrence of fraud
Effective internal controls assist in the provision of reliable Financial Statements and the detection and prevention of fraud. Testing of internal controls provide only limited assurance over the accuracy of Financial Statements and may not prevent or detect misstatements or fraud.
Impact
Significant resources may be required to remediate any deficiency in internal controls. Any such deficiency may trigger related investigations and may result in fines being levied against individual directors or officers. Serious fraud may lead to prosecution of senior management.
Unexpected deterioration in the Group’s financial position
Product sales in countries other than the US are predominantly in currencies other than the US dollar, including the Chinese renminbi, the euro, Japanese yen and pound sterling.
A number of our existing or future commercial agreements, such as borrowings, derivative financial instruments and commercial contracts, utilise or may utilise various London Interbank Offered Rates (LIBOR), or other similar rates as benchmark reference rates. These rates are the subject of ongoing regulatory reform, the result of which is expected to see some or all of them partially or fully replaced by alternative reference rates.
The majority of our cash investments are managed centrally and are invested in AAA credit-rated institutional money market funds, collateralised bank deposits, fixed income securities in government, and financial and non-financial securities. This means our credit exposure is a mix of US, EU and rest of world sovereign default risk, financial institution and non-financial institution default risk.
Our consolidated balance sheet contains significant investments in intangible assets, including goodwill. The pharmaceutical business is high risk, and we invest in a large number of projects in an effort to develop a successful portfolio of approved products. Our ability to realise value on these investments depends on regulatory approvals, market acceptance, competition and legal developments.
Our defined benefit post-retirement obligations (the most significant of which are for the UK, Sweden and US) can materially change in value, but are largely backed by invested assets.
We maintain relevant insurance coverage for risks arising within the Group. Revenue authorities can make conflicting claims as to the profits to be taxed in individual countries.
The Organisation for Economic Co-operation and Development (OECD) has introduced a number of changes under the Base Erosion and Profit Shifting (BEPS) Action Plans which are now being progressively implemented by tax authorities around the world. In December 2021, the OECD published the Global Anti-Base Erosion (GloBE) rules, setting out the framework the 130 countries which are members of the Inclusive Framework are expected to introduce from 2023, which taxes profits of large groups at a minimum rate of 15% in each country in which they operate. It is also considering further potential actions which would potentially include allocating taxing rights over a higher proportion of profits to end market jurisdictions, and is now seeking a consensus amongst the Inclusive Framework members on those changes.
Impact
Currency fluctuations can significantly affect our results of operations, which are reported in US dollars. Movements in exchange rates against the US dollar may materially adversely affect our financial condition or results of operations.
11
This may result in potential adjustments or renegotiations being necessary to our agreements. While different alternative reference rates are developing, there is a risk that we fail to renegotiate or adjust our agreements. This could have an adverse effect on the cost, cash flows, value, return on and trading market of (as appropriate) our borrowings, derivative financial instruments and other agreements.
In a sustained economic downturn, financial institutions may cease to trade and there can be no guarantee that we will be able to access monies owed to us.
We expect that some of our intangible assets will become impaired in the future. Impairment losses may materially adversely affect our financial condition or results of operations. Details of the carrying values of goodwill and intangible assets, are included in “Financial Statements—Notes to the Group Financial Statements—Note 9—Goodwill” on page 156 and “—Note 10—Intangible assets” on page 156 to 159, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022. Solvency levels could fall, leading to higher contributions if there are: falls in assets; increases in liability valuations (driven by falls in bond yields, increases in future inflation or lower than expected mortality); or changes in regulations. A material increase in deficit may cause credit agencies to downgrade our rating, negatively affecting our ability to borrow. For more information, please see “Financial Statements—Notes to the Group Financial Statements—Note 22—Post-retirement and other defined benefit schemes” on pages 168 to 175 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022.
Financial liabilities arising where we do not have insurance coverage, or where an insurer successfully denies coverage, could materially adversely affect our financial condition. For more information, see “Adverse outcome of litigation and/or governmental investigations” above.
The resolution of tax disputes regarding the profits to be taxed in individual territories can result in a reallocation of profits or losses between jurisdictions, or even double taxation, and an increase or decrease in related tax costs, and has the potential to affect our cash flows, EPS and post-tax earnings. Claims, regardless of their merits or their outcome, are costly, divert management attention and may adversely affect our reputation.
If tax treaties are withdrawn or amended, this could materially adversely affect our financial condition or results of operations, as could a negative outcome of a tax dispute or a failure by tax authorities to agree to eliminate double taxation. Changes to the application of tax treaties or the availability of the EU arbitration convention following Brexit could also result in adverse consequences, such as those described above. For tax risk management policies, please see “Financial Review—Financial risk management” on page 66, and for details of current tax disputes, please see “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments and contingent liabilities” on pages 189 to 196, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022.
Changes in tax regimes could result in a material impact on the Group’s cash tax liabilities and tax charge, resulting in either an increase or a reduction in financial results. Specific OECD BEPS recommendations that we expect to impact the Group include changes to patent box regimes, restrictions of interest deductibility, global minimum tax rate and revised transfer pricing guidelines allocating more profits to end user markets.
ITEM 4. INFORMATION ON THE COMPANY
A. History and Development of the Company
AstraZeneca PLC was incorporated in England and Wales on June 17, 1992 under the Companies Act 1985. It is a public limited company domiciled in the UK. The Company’s registered number is 2723534 and its registered office is at 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge CB2 0AA, UK (Tel: +44 (0)20 3749 5000). From February 1993 until April 1999, the Company was called Zeneca Group PLC. On April 6, 1999, the Company changed its name to AstraZeneca PLC.
The Company was formed when the pharmaceutical, agrochemical and specialty chemical businesses of Imperial Chemical Industries PLC were demerged in 1993. In 1999, the Company sold the specialty chemical business. Also in 1999, the Company merged with Astra of Sweden. In 2000, it demerged the agrochemical business and merged it with the similar business of Novartis to form a new company called Syngenta AG. In 2007, the Group acquired MedImmune, a biologics and vaccines business based in the US. In 2021, the Group acquired Alexion, a rare disease business based in the US.
In 1999, in connection with the merger between Astra and Zeneca, the Company’s share capital was redenominated in US dollars. On 6 April 1999, Zeneca shares were cancelled and US dollar shares issued, credited as fully paid on the basis of one dollar share for each Zeneca share then held.
12
This was achieved by a reduction of capital under section 135 of the Companies Act 1985. Upon the reduction of capital becoming effective, all issued and unissued Zeneca shares were cancelled and the sum arising as a result of the share cancellation credited to a special reserve, which was converted into US dollars at the rate of exchange prevailing on the record date. This US dollar reserve was then applied in paying up, at par, newly created US dollar shares.
At the same time as the US dollar shares were issued, the Company issued 50,000 Redeemable Preference Shares for cash, at par. The Redeemable Preference Shares carry limited class voting rights, no dividend rights and are capable of redemption, at par, at the option of the Company on the giving of seven days’ written notice to the registered holder of the Redeemable Preference Shares.
A total of 826 million Ordinary Shares were issued to Astra shareholders who accepted the merger offer before the final closing date, 21 May 1999. The Company received acceptances from Astra shareholders representing 99.6% of Astra’s shares and the remaining 0.4% was acquired in 2000, for cash.
In 2021 in connection with the acquisition of Alexion a total of 236 million Ordinary Shares (the majority of which were represented by new AstraZeneca ADRs) were issued to Alexion shareholders in part consideration for the acquisition.
The information (including tabular data) set forth under the headings “Strategic Report—Financial Review— Collaboration Revenue” on page 59, “Strategic Report—Financial Review— Business combinations” on page 63, “Strategic Report—Financial Review— Investments, divestments and capital expenditure” on page 65, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Board Leadership and Company Purpose” on page 77 and “Additional Information—Important information for readers of this Annual Report— AstraZeneca websites” on page 228, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
The United States Securities and Exchange Commission (the “SEC”) maintains a website at www.sec.gov which contains in electronic form each of the reports and other information that we have filed electronically with the SEC.
B. Business Overview
The information (including graphs and tabular data) set forth under the headings “Strategic Report—AstraZeneca at a glance” on pages 2 to 3, “Strategic Report—Chair’s Statement” on page 4, “Strategic Report—Chief Executive Officer’s Review” on pages 5 to 6, “Strategic Report—Our strategy and Key Performance Indicators” on pages 12 to 15, “Strategic Report—Healthcare in a Changing World” on pages 7 to 9; “Strategic Report—Business Review” on page 30 to 47, “Strategic Report—Disease Area Review” on pages 16 to 29, “Strategic Report— Risk Overview—Managing risk”, “—Risk Overview— Emerging risks”, “—Risk Overview—Climate risk” on page 48, “Strategic Report—Risk Overview—COVID-19 pandemic” on page 49, “Corporate Governance—Corporate Governance Report—Other Governance information—Global Compliance and Internal Audit Services (IA)” on page 79, “Additional Information—Sustainability: supplementary information” on page 216, “Additional Information—Task force on Climate-related Financial Disclosures Statement” on pages 216 to 222, “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” on pages 145 to 146, “Financial Statements—Notes to the Group Financial Statements—Note 6—Segment information” on pages 152 to 153, and “Additional Information—Important information for readers of this Annual Report—Statements of competitive position, growth rates and sales” on page 228, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
Development Pipeline as of February 10, 2022
This section sets out AstraZeneca-sponsored or -directed trial New Molecular Entities (NMEs) and significant indications Regulatory submission dates shown for assets in Phase III and beyond. As disclosure of compound information is balanced by the business need to maintain confidentiality, information in relation to some compounds listed here has not been disclosed at this time.
Key:
PP = Partnered product
13
Phase I
Compound |
| Mechanism |
| Area Under Investigation |
Oncology | ||||
AZD0466 | BCL2/xL (PP) | haematological malignancies | ||
AZD1390 | ATM inhibitor | glioblastoma | ||
AZD2936 | PD1/TIGIT bispecific mAb (PP) | solid tumours | ||
AZD4573 | CDK9 inhibitor | haematalogical malignancies | ||
AZD5991 | MCL1 inhibitor | haematalogical malignancies | ||
AZD7648 | DNAPK (PP) | haematological and solid tumours | ||
AZD7789 | PD1/TIM3 bispecific mAb | solid tumours | ||
AZD8701+/- Imfinzi | FOXP3 +/- PD-L1 (PP) | solid tumours | ||
Imfinzi + adavosertib | PD-L1 mAb + Wee1 inhibitor (PP) | solid tumours | ||
IPH5201 | CD39 (PP) | solid tumours | ||
MEDI1191 | IL12 mRNA (PP) | solid tumours | ||
MEDI5752 + lenvatinib | PD-1/CTLA-4 bispecific mAb + VEGF | advanced renal cell carcinoma | ||
MEDI9253 | rNDV IL12 | solid tumours | ||
Tagrisso + (Koselugo or savolitinib) | EGFR inhibitor + (MEK inhibitor or MET inhibitor) (PP) | advanced EGFRm non-small cell lung cancer | ||
CVRM | ||||
AZD2373 | Podocyte health | nephropathy | ||
AZD2693 | NASH resolution | non-alcoholic steatohepatitis | ||
AZD3366 | CD39L3 | cardiovascular disease | ||
AZD3427 | Relaxin ThP | cardiovascular disease | ||
AZD5462 | Relaxin mimetic | cardiovascular disease | ||
AZD7503 | ASO | non-alcoholic steatohepatitis | ||
MEDI8367 | avb8 | chronic kidney disease | ||
Respiratory & Immunology | ||||
AZD4604 | Inhaled JAK1 inhibitor | asthma | ||
AZD5055 | Porcupine inhibitor | idiopathic pulmonary fibrosis | ||
AZD8630 | Inhaled TSLP mAb | asthma | ||
Rare Disease | ||||
ALXN1720 | subcutaneous anti-C5 bi-specific | generalized Myasthenia Gravis | ||
ALXN1820 | anti-properdin bi-specific | haematology | ||
ALXN1850 | next-generation asfotase alfa | hypophosphatasia | ||
Other | ||||
AZD4041 | orexin 1 receptor antagonist (PP) | opioid use disorder | ||
MEDI0618 | PAR2 antagonist mAb | osteoarthritis pain | ||
MEDI1341 | alpha synuclein mAb (PP) | Parkinson’s disease | ||
MEDI1814 | amyloid beta mAb (PP) | Alzheimer’s disease |
14
Phase II
Compound |
| Mechanism |
| Area Under Investigation |
Oncology | ||||
adavosertib | Wee1 inhibitor (PP) | ovarian cancer, solid tumours, uterine serous cancer | ||
AZD0171 + Imfinzi + CTx | anti-LIF mAb + PD-L1 mAb + CTx | 1L metastatic pancreatic ductal adenocarcinoma | ||
AZD4573 + Calquence | CDK9 inhibitor + BTK inhibitor | haematological malignancies | ||
AZD5305 | PARP1Sel | solid tumours | ||
Camizestrant (AZD9833) | Selective estrogen receptor degrader | estrogen receptor +ve breast cancer | ||
capivasertib | AKT inhibitor (PP) | prostate cancer | ||
ceralasertib | ATR inhibitor | solid tumours | ||
Imfinzi (platform)COAST | PD-L1 mAb + multiple novel oncology therapies (PP) | non-small cell lung cancer | ||
Imfinzi (platform) HUDSON | PD-L1 mAb + multiple novel oncology therapies | post IO non-small cell lung cancer | ||
Imfinzi (platform) NeoCOAST | PD-L1 mAb + multiple novel oncology therapies (PP) | non-small cell lung cancer | ||
Imfinzi + FOLFOX + bevacizumabL COLUMBIA1 | PD-L1 mAb + CTx + VEGF | 1st-line metastatic microsatellite-stable colorectal cancer | ||
Imfinzi + LynparzaL ORION | PD-L1 mAb + PARP inhibitor (PP) | 1st-line metastatic non-small cell lung cancer | ||
Imfinzi + monalizumab | PD-L1 mAb + NKG2a mAb PD-1/CTLA-4 (PP) | solid tumours | ||
MEDI5752 | PD-1/CTLA-4 Bispecific mAb | solid tumours | ||
oleclumab+CTx or Imfinzi+oleclumab+CTx | CD73 mAb + CTx or (PD-L1 mAb + CD73 mAb + CTx | metastatic pancreatic cancer | ||
Post-1L Tagrisso ORCHARD (platform) | EGFR inhibitor + multiple novel oncology therapies | EGFRm non-small cell lung cancer | ||
Tagrisso + savolitinib SAVANNAH | EGFR inhibitor + MET inhibitor (PP) | advanced EGFRm non-small cell lung cancer | ||
CVRM | ||||
AZD4831 | myeloperoxidase | heart failure with a preserved ejection fraction | ||
AZD5718 | FLAP | coronary artery disease/chronic kidney disease | ||
AZD8233 | Hypercholesterolemia | cardiovascular disease | ||
AZD8601 | VEGF-A (PP) | cardiovascular disease | ||
AZD9977 + Farxiga/Forxiga | MR modulator + SGLT2 inhibitor | heart failure with chronic kidney disease | ||
cotadutide | GLP-1/glucagon dual agonist | type-2 diabetes, obesity and NASH, diabetic kidney disease | ||
MEDI6570 | LOX-1 mAb | cardiovascular disease | ||
tozorakimab | IL33 mAb | diabetic kidney disease | ||
zibotentan +Farxiga/Forxiga ZENITH-CKD | ETA antagonist + SGLT2 (PP) | chronic kidney disease | ||
Respiratory & Immunology | ||||
AZD1402 | Inhaled IL4Ra (PP) | asthma | ||
AZD7986 | DPP1 (PP) | chronic obstructive pulmonary disease | ||
brazikumab EXPEDITION | IL23 mAb | ulcerative colitis | ||
tozorakimab | IL33 mAb | COPD/atopic dermatitis/asthma/COVID-19 | ||
Rare Disease | ||||
ALXN2050 | oral factor D inhibitor | Paroxysmal Nocturnal Hemoglobinuria | ||
danicopan (ALXN2040) | oral factor D inhibitor | Geographic atrophy | ||
Other | ||||
MEDI7352 | NGF/TNF bispecific mAb | osteoarthritis pain and painful diabetic neuropathy |
15
Phase III
|
|
|
| Estimated filing acceptance | ||||||||||
Compound | Mechanism | Area Under Investigation | Additional | US | EU | Japan | China | |||||||
Oncology | ||||||||||||||
camizestrant + CDK4/6i SERENA-6 | selective estrogen receptor degrader + CDK4/6 inhibitors | 1L HR+ HER2- ESR1m breast cancer | 2023+ | 2023+ | 2023+ | |||||||||
camizestrant + palbociclib SERENA-4 | selective estrogen receptor degrader + CDK4/6 inhibitor | 1st-line HR+ HER2- breast cancer | 2023+ | 2023+ | 2023+ | 2023+ | ||||||||
capivasertib + abiraterone CAPItello-281 | AKT inhibitor + abiraterone | PTEN deficient metastatic hormone sensitive prostate cancer | (PP) | 2023+ | 2023+ | 2023+ | 2023+ | |||||||
capivasertib + CTx CAPItello-290 | AKT inhibitor + CTx | 1st-line metastatic triple negative breast cancer | (PP) | 2023 | 2023 | 2023 | 2023+ | |||||||
capivasertib + fulvestrant CAPItello-291 | AKT inhibitor + fulvestrant | 2nd- line and beyond in AI resistant locally advanced (inoperable) or metastatic breast cancer | (PP) | 2023 | 2023 | 2023 | 2023+ | |||||||
capivasertib + fulvestrant + palbociclib CAPItello-292 | AKT inhibitor + fulvestrant + CDK4/6 inhibitor | 1st-line triplet in early relapse/ET resistant locally advanced (inoperable) or metastatic breast cancer | (PP) | 2023+ | 2023+ | 2023+ | 2023+ | |||||||
datopotamab deruxtecan TROPION-Lung01 | TROP2 targeting antibody drug conjugate | 2L+ NSCLC without actionable genomic mutations | (PP) | 2023 | 2023 | 2023 | 2023+ | |||||||
datopotamab deruxtecan# TROPION-Breast01 | TROP-2 targeting antibody drug conjugate | 2-3L HR+ HER2- breast cancer | (PP) | 2023+ | 2023+ | 2023+ | 2023+ | |||||||
Imfinzi +/- tremelimumab + CTx POSEIDON | PD-L1 mAb +/- CTLA-4 mAb + CTx | 1st-line non-small cell lung cancer | (PP) | Accepted | Accepted | Submitted | 2023+ | |||||||
Imfinzi + tremelimumab HIMALAYA | PD-L1 mAb + CTLA-4 mAb | 1st-line hepatocellular carcinoma | (PP) | H1 2022 (Orphan Drug Designation) | H1 2022 (Organ designation) | H1 2022 | 2023+ | |||||||
Imfinzi + tremelimumab + SoC NILE | PL-L1 mAb + CTLA-4 mAb + SoC | 1st-line urothelial cancer | (PP) | 2023 | 2023 | 2023 | 2023+ | |||||||
Imfinzi +/- tremelimumab + CRT ADRIATIC | PD-L1 mAb +/- CTLA-4 mAb + CRT | 1st-line limited-stage small-cell lung cancer | (PP) | 2023 | 2023 | 2023 | 2023 | |||||||
Koselugo/selumetinib SPRINT | MEK inhibitor | paediatric neurofibromatosis type-1 | (PP) | Launched (Priority Review, Breakthrough, Therapy, Orphan Drug Designation) | (Breakthrough Therapy, Orphan designation) | Submitted (Orphan Drug) | H2 2022 | |||||||
Lynparza + Imfinzi + bevacizumab DuO-O | PARP inhibitor + PD-L1 mAb + VEGF inhibitor | 1st-line ovarian cancer | (PP) | 2023+ | 2023+ | 2023+ | 2023+ | |||||||
Lynparza + Imfinzi DuO-E | PARP inhibitor + PD-L1 mAb | 1st-line endometrial cancer | (PP) | 2023+ | 2023+ | 2023+ | 2023+ | |||||||
monalizumab + cetuximab INTERLINK-1 | NKG2a mAb + EGFR mAb | 2L+ relapsed metastatic head and neck squamous cell cancer | (PP) | 2023+ | 2023+ | 2023+ | N/A | |||||||
savolitinib + Imfinzi SAMETA | MET inhibitor + PD-L1 mAb | 1st-line papillary renal cell carcinoma | (PP) | 2023+ | 2023+ | 2023+ | ||||||||
CVRM | ||||||||||||||
eplontersen | Ligand-conjugated antisense | patients with hereditary transthyretinmediated amyloid polyneuropathy | (PP) | H2 2022 (Orphan Drug Designation | ||||||||||
eplontersen | Ligand-conjugated antisense | patients with hereditary transthyretinmediated amyloid polyneuropathy | (PP) | 2023+ (Orphan Drug Designation | 2023+ | |||||||||
Roxadustat OLYMPUS/ ROCKIES | Hypoxia-inducible factor prolyl hydroxylase inhibitor | anaemia in chronic kidney disease/end-stage renal disease | (PP) | Launched | ||||||||||
Respiratory & Immunology | ||||||||||||||
Brazikumab INTREPID | IL23 mAb | Crohn’s disease | 2023+ | 2023+ | 2023+ | 2023+ | ||||||||
Fasenra CALIMA SIROCCO ZONDA BISE BORA GREGALE MIRACLE | IL5R mAb | severe uncontrolled asthma | (PP) | Launched | Launched | Launched | 2023 | |||||||
PT027 | ICS/SABA | asthma | (PP) | H1 2022 | ||||||||||
Saphnelo TULIP 1 & TULIP 2 (China) | Type I IFN receptor mAb | systemic lupus erythematosus | (PP) | Launched (Fast Track, Orphan Drug Designation) | Accepted | Approved | 2023+ | |||||||
Tezspire (tezepelumab) NAVIGATOR DIRECTION | TSLP mAb | severe uncontrolled asthma | (PP) | Launched (Priority Review) | Accepted | Accepted | 2023+ | |||||||
Rare Disease | ||||||||||||||
Acoramidis (ALXN2060) | oral TTR stabilizer | Transthyretin Amyloid Cardiomyopathy (ATTR-CM) | (PP) | 2023 | ||||||||||
ALXN1840 | bis-choline tetrathiomolybdate | Wilson’s disease | H2 2022 (Orphan Drug Designation) | H2 2022 (Orphan Drug Designation) | H2 2022 | |||||||||
CAEL-101 | fibril-reactive mAb | AL amyloidosis | 2023+ (Fast Track, Orphan Drug Designation) | 2023+ (Fast Track, Orphan Drug Designation) | 2023+ | |||||||||
danicopan (ALXN2040) | factor D inhibitor | Paroxysmal Nocturnal Hemoglobinuria-Extravascular Hemolysis | 2023 (Orphan Drug Designation) | 2023 (Orphan Drug Designation) | 2023 | |||||||||
Other and COVID-19 | ||||||||||||||
Evusheld (AZD7442) | COVID-19 LAAB combination | prevention and treatment of COVID-19 | Prophylaxis FDA EUA submission approved | Approved (Emergency Use) | H1 2022 | H1 2022 | H1 2022 | |||||||
nirsevimab | RSV mAb-YTE | passive RSV immunisation | (PP) | H2 2022 (Fast Track Designation, Breakthrough Therapy Designation) | H1 2022 (PRIME) | 2023 | 2023 (Breakthrough Therapy Designation) | |||||||
Vaxzevria | SARS-CoV-2 | COVID vaccine | (PP) EMA and Japan Conditional Marketing Authorisation | H1 2022 | Launched | Launched | ||||||||
16
Significant Life-cycle Management
|
|
|
| Estimated filing acceptance | ||||||||||
Compound | Mechanism | Area Under | Additional | US |
| EU |
| Japan |
| China | ||||
Oncology | ||||||||||||||
Calquence ASCEND | BTK inhibitor | relapsed/refractory chronic lymphocytic leukaemia | (PP) | Launched (Breakthrough Therapy Orphan Drug Designation) | Launched | Approved | 2023 | |||||||
Calquence ELEVATE-TN | BTK inhibitor | 1st-line chronic lymphocytic leukaemia | (PP) | Launched (Breakthrough Therapy Orphan Drug Designation) | Launched | H2 2022 | 2023+ | |||||||
Calquence + R-CHOP ESCALADE | BTK inhibitor + R-CHOP | 1st-line Diffuse Large B Cell Lymphoma | 2023+ | 2023+ | 2023+ | 2023+ | ||||||||
Calquence + venetoclax + obinutuzumab AMPLIFY | BTK inhibitor + BCL-2 inhibitor + anti-CD20 mAb | 1st-line chronic lymphocytic leukaemia | (PP) | 2023+ | 2023+ | N/A | 2023+ | |||||||
Calquence ECHO | BTK inhibitor | 1st-line mantle cell lymphoma | (PP) 2023 (Orphan Drug Designation) | 2023 | 2023 | 2023 | 2023 | |||||||
Enhertu DESTINY-Breast02 | HER2 targeting antibody drug conjugate | HER2-positive, unresectable and/or metastatic breast cancer pretreated with prior standard of care HER2 therapies, including T-DM1 | (PP) | H2 2022 | H2 2022 | N/A | N/A | |||||||
Enhertu DESTINY-Breast03 | HER2 targeting antibody drug conjugate | HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab and taxane | (PP) | Accepted (Breakthrough Therapy Designation, Priority Review) | Accepted | Submitted | H1 2022 | |||||||
Enhertu DESTINY-Breast04 | HER2 targeting antibody drug conjugate | HER2-low, unresectable and/or metastatic breast cancer | (PP) | H1 2022 | H1 2022 | H1 2022 | H2 2022 | |||||||
Enhertu DESTINY-Breast05 | HER2 targeting antibody drug conjugate | HER2-positive post-neoadjuvant high-risk breast cancer | (PP) | H1 2022 | H1 2022 | H1 2022 | H2 2022 | |||||||
Enhertu DESTINY-Breast06 | HER2 targeting antibody drug conjugate | post-ET HER2-low/HR+ breast cancer 2L | (PP) | 2023+ | 2023+ | 2023+ | 2023+ | |||||||
Enhertu (platform) DESTINY-Breast07 | HER2 targeting antibody drug conjugate | HER2+ breast cancer | Phase II (PP) | |||||||||||
Enhertu (platform) DESTINY-Breast08 | HER2 targeting antibody drug conjugate | HER2-low breast cancer | Phase I (PP) | |||||||||||
Enhertu DESTINY-Breast09 | HER2 targeting antibody drug conjugate | 1st line HER2-postitive breast cancer | (PP) | 2023+ | 2023+ | 2023+ | 2023+ | |||||||
Enhertu DESTINY-Breast11 | HER2 targeting antibody drug conjugate | neoadjuvant HER2-positive breast cancer | (PP) | |||||||||||
Enhertu DESTINY-Gastric01 | HER2 targeting antibody drug conjugate | HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens | Phase II EU submission includes data from Gastric02 (PP) | Approved (Priority Review, Breakthrough Therapy, Orphan Drug Designation) | Accepted | Approved | 2023+ | |||||||
Enhertu DESTINY-Gastric04 | HER2 targeting antibody drug conjugate | 2nd-line HER2-positive gastric cancer | (PP) | 2023+ | 2023+ | 2023+ | 2023+ | |||||||
Enhertu DESTINY-Lung01 | HER2 targeting antibody drug conjugate | HER2-over-expressing or -mutated, unresectable and/or metastatic non-small cell lung cancer | Phase II (PP) | Breakthrough Therapy | ||||||||||
Enhertu DESTINY-Lung04 | HER2 targeting antibody drug conjugate | 1st-line non-small cell lung cancer | (PP) | 2023+ | 2023+ | 2023+ | 2023+ | |||||||
Enhertu DESTINYPanTumour01 | HER2 targeting antibody drug conjugate | HER2-expressing solid tumors | Phase II (PP) | |||||||||||
Enhertu DESTINYPanTumour02 | HER2 targeting antibody drug conjugate | HER2-expressing solid tumors | Phase II (PP) | |||||||||||
Imfinzi PEARL | PD-L1 mAb | 1st-line metastatic non-small cell lung cancer | (PP) | H2 2022 | H2 2022 | H2 2022 | H2 2022 | |||||||
Imfinzi + CRT PACIFIC-2 | PD-L1 mAb + CRT | locally-advanced (stage III) non-small cell lung cancer | (PP) | H2 2022 | H2 2022 | H2 2022 | ||||||||
Imfinzi post-SBRT PACIFIC-4 | PD-L1 mAb post-SBRT | stage I/II non-small cell lung cancer | (PP) | 2023+ | 2023+ | 2023+ | 2023+ | |||||||
Imfinzi + CRT PACIFIC-5 (China) | PD-L1 mAb + CRT | locally-advanced (stage III) non-small cell lung cancer | (PP) | 2023 | ||||||||||
Imfinzi + CTx neoadjuvant AEGEAN | PD-L1 mAb + CTx | locally-advanced (stage II-III) non-small cell lung cancer | (PP) | 2023 | 2023 | 2023 | 2023+ | |||||||
Imfinzi + CTx MERMAID-1 | PD-L1 mAb + CTx | stage II-III adjuvant non-small cell lung cancer | 2023+ | 2023+ | 2023+ | 2023+ | ||||||||
Imfinzi MERMAID-2 | PD-L1 mAb | stage II-III premetastatic non-small cell lung cancer | 2023+ | 2023+ | 2023+ | 2023+ | ||||||||
Imfinzi + CRT KUNLUN | PD-L1 mAb + CRT | locally advanced esophageal squamous cell carcinoma | (PP) | 2023+ | 2023+ | 2023+ | 2023+ | |||||||
Imfinzi + CTx TOPAZ-1 | PD-L1 mAb + CTx | 1st-line biliary tract cancer | (PP) | H1 2022 (Orphan Drug Designation) | H1 2022 | H1 2022 | H1 2022 | |||||||
Imfinzi + FLOT MATTERHORN | PD-L1 mAb + CTx | Neo-adjuvant/adjuvant gastric cancer | (PP) | 2023+ | 2023+ | 2023+ | 2023+ | |||||||
17
Imfinzi + VEGF + TACE EMERALD-1 | PD-L1 mAb + VEGF + TACE | locoregional hepatocellular carcinoma | (PP) | H2 2022 | H2 2022 | H2 2022 | 2023 | |||||||
Imfinzi + VEGF EMERALD-2 | PD-L1 mAb + VEGF | adjuvant hepatocellular carcinoma | (PP) | 2023 | 2023 | 2023 | 2023 | |||||||
Imfinzi CALLA | PD-L1 mAb | locally-advanced cervical cancer | (PP) | H2 2022 | H2 2022 | H2 2022 | H2 2022 | |||||||
Imfinzi + CTx NIAGARA | PD-L1 mAb + CTx | muscle invasive bladder cancer | (PP) | 2023 | 2023 | 2023 | N/A | |||||||
Imfinzi + EV +/- treme VOLGA | PD-L1 + nectin-4 targeting antibody drug conjugate +/- CTLA4 | muscle invasive bladder cancer | 2023+ | 2023+ | 2023+ | N/A | ||||||||
Imfinzi POTOMAC | PD-L1 mAb | non muscle invasive bladder cancer | (PP) | 2023+ | 2023+ | 2023+ | N/A | |||||||
Imfinzi (platform) MAGELLAN | PD-L1 mAb + multiple novel oncology therapies +/- CTx | 1st-line metastatic non-small cell lung cancer | Phase II (PP) | |||||||||||
Imfinzi (platform) BEGONIA | PD-L1 mAb with paclitaxel and mulitiple novel oncology therapies | 1st-line metastatic triple negative breast cancer | Phase II (PP) | |||||||||||
Lynparza OlympiA | PARP inhibitor | gBRCA adjuvant breast cancer | (PP) | Accepted (Priority Review) | Accepted | Submitted (Orphan Drug Designation) | 2023 | |||||||
Lynparza (basket) MK-7339-002 / LYNK002 | PARP inhibitor | HRRm cancer | Phase II (PP) | |||||||||||
Lynparza + abiraterone PROpel | PARP inhibitor + NHA | prostate cancer | (PP) | H2 2021 | Accepted | H1 2022 | 2023+ | |||||||
Lynparza LYNK-003 | PARP inhibitor | platinum sensitive 1st-line colorectal cancer | (PP) | 2023 | 2023 | 2023 | 2023 | |||||||
Lynparza MONO-OLA1 | PARP inhibitor | 1st-line BRCAwt ovarian cancer | (PP) | 2023+ | 2023+ | 2023+ | 2023+ | |||||||
Tagrisso LAURA | EGFR inhibitor | stage III EGFRm non-small cell lung cancer | 2023 | 2023 | 2023 | 2023 | ||||||||
Tagrisso + CTx FLAURA2 | EGFR inhibitor + CTx | 1st-line advanced EGFRm non-small cell lung cancer | 2023 | 2023 | 2023 | |||||||||
Tagrisso +/- CTx neoadjuvant NeoADAURA | EGFR inhibitor +/- CTx | stage II/III resectable EGFRm NSCLC | 2023+ | 2023+ | 2023+ | 2023+ | ||||||||
Tagrisso ADAURA | EGFR inhibitor | adjuvant EGFRm non-small cell lung cancer | Launched (Breakthrough Therapy Designation, Priority Review) | Approved | Submitted | Launched | ||||||||
CVRM | ||||||||||||||
Brilinta/Brilique THALES | P2Y12 receptor antagonist | acute ischaemic stroke or transient ischaemic attack | Brilinta in the US; Brilique in rest of world. | Launched | Accepted | N/A | Accepted | |||||||
Bydureon BCise (autoinjector) | GLP-1 receptor agonist | type-2 diabetes | Launched | Launched | N/A | H2 2022 | ||||||||
Farxiga/Forxiga DAPA-CKD | SGLT-2 inhibitor | renal outcomes and cardiovascular mortality in patients with chronic kidney disease | Farxiga in the US; Forxiga in rest of world. | Launched (Fast Track, Breakthrough Therapy Designation) | Launched | Launched (Priority Review) | Accepted | |||||||
Farxiga/Forxiga DAPA-MI | SGLT-2 inhibitor | prevention of heart failue and CV death following a myocardial infarction | 2023+ | 2023+ | N/A | N/A | ||||||||
Farxiga/Forxiga DELIVER | SGLT-2 inhibitor | worsening HF or CV death in patients with chronic HF (HFpEF) | H2 2022 | H2 2022 | H2 2022 | H2 2022 | ||||||||
Lokelma DIALIZE-Outcomes | Potassium binder | CV outcomes in patients on chronic hemodialysis with hyperkalaemia | 2023+ (Fast Track) | 2023+ | N/A | 2023+ | ||||||||
Lokelma STABILIZE-CKD | Potassium binder | hyperkalaemia in CKD | 2023+ | 2023+ | 2023+ | 2023+ | ||||||||
roxadustat | Hypoxiainducible factor prolyl hydroxylase inhibitor | anaemia in myelodysplastic syndrome | (PP) | 2023+ | 2023+ | |||||||||
roxadustat | Hypoxiainducible factor prolyl hydroxylase inhibitor | chemotherapy induced anaemia | Phase II (PP) | |||||||||||
Xigduo XR/Xigduo | SGLT-2 inhibitor/ metformin FDC | type-2 diabetes | Launched | Launched | H1 2022 | |||||||||
Respiratory & Immunology | ||||||||||||||
Breztri/Trixeo (PT010) KALOS, LAGOS | LABA/LAMA/ICS | asthma | 2023+ | 2023+ | 2023+ | 2023+ | ||||||||
Fasenra RESOLUTE | IL5R mAb | COPD | (PP) | 2023+ | 2023+ | 2023+ | ||||||||
Fasenra ARROYO | IL5R mAb | chronic spontaneous urticaria | Phase II | |||||||||||
Fasenra FJORD | IL5R mAb | bullous pemphigoid | 2023+ | 2023+ | 2023+ | 2023+ | ||||||||
Fasenra HILLIER | IL5R mAb | atopic dermatitis | Phase II | |||||||||||
Fasenra MAHALE | IL5R mAb | non-cystic fibrosis bronchiectasis | 2023+ | 2023+ | 2023+ | |||||||||
Fasenra MANDARA | IL5R mAb | eosinophilic granulomatosis with polyangiitis | 2023 | 2023 | 2023 | 2023+ | ||||||||
Fasenra MESSINA | IL5R mAb | eosinophilic esophagitis | 2023 | 2023 | 2023 | |||||||||
Fasenra NATRON | IL5R mAb | hypereosinophilic syndrome | 2023 | 2023 | 2023 | 2023+ | ||||||||
Fasenra OSTRO ORCHID(China/ Japan) | IL5R mAb | nasal polyps | (PP) | Accepted | 2023+ | 2023+ | ||||||||
Saphnelo | Type I IFN receptor mAb | lupus nephritis | Phase II (PP) | |||||||||||
Saphnelo TULIP-SC | Type I IFN receptor mAb | systemic lupus erythematosus (subcutaneous) | (PP) | 2023+ | 2023+ | 2023+ | ||||||||
Tezspire (tezepelumab) | TSLP mAb | chronic obstructive pulmonary disease | Phase II (PP) | |||||||||||
Tezspire (tezepelumab) WAYPOINT | TSLP mAb | nasal polyps | (PP) | 2023+ | 2023+ | 2023+ | 2023+ | |||||||
Rare Disease |
18
Andexxa (ALXN2070) | anti-factor Xa reversal | urgent surgery | Phase II | |||||||||||
Andexxa (ALXN2070) | anti-factor Xa reversal | Acute Major Bleed | Launched Accelerated approval) | Launched | Accepted (Orphan drug) | |||||||||
Ultomiris (ALXN1210) | anticomplement C5 mAb | dermatomyositis | Phase II/III | |||||||||||
Ultomiris (ALXN1210) | anticomplement C5 mAb | generalized Myasthenia Gravis | Accepted (Priority Review) | Accepted | Accepted | |||||||||
Ultomiris (ALXN1210) | anticomplement C5 mAb | Neuromyelitis Optica Spectrum Disorder | H2 2022 | H2 2022 | H2 2022 | |||||||||
Ultomiris (ALXN1210) | anticomplement C5 mAb | Hematopoietic Stem Cell Transplant– associated Thrombotic Microangiopathy | 2023+ (Orphan Drug Designation) | 2023+ | 2023+ | |||||||||
Ultomiris (ALXN1210) | anticomplement C5 mAb | Subcutaneous administration Paroxysmal Nocturnal Hemoglobinuria and atypical Hemolytic Uremic Syndrome | Accepted (Orphan Drug Designation) | H1 2022 | ||||||||||
Ultomiris (ALXN1210) | anticomplement C5 mAb | complement-mediated thrombotic microangiopathy | 2023+ | 2023+ |
Recent Pipeline Developments
Enhertu DESTINY-Breast04
On February 21, 2022, we announced positive high-level results from the pivotal DESTINY-Breast04 Phase III trial showed Enhertu (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) in patients with HER2-low unresectable and/or metastatic breast cancer regardless of hormone receptor (HR) status versus physician's choice of chemotherapy. Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo.
Saphnelo (anifrolumab)
On February 16, 2022, we announced that AstraZeneca's Saphnelo (anifrolumab) has been approved in the European Union as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite receiving standard therapy.
Lynparza (olaparib)
On February 15, 2022, we announced that positive results from the PROpel Phase III trial showed AstraZeneca and MSD's Lynparza (olaparib) in combination with abiraterone demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) versus current standard-of-care abiraterone as a 1st-line treatment for patients with metastatic castration-resistant prostate cancer (mCRPC) with or without homologous recombination repair (HRR) gene mutations.
Patent Expiries of Key Marketed Products
Patents covering our products are, or may be, challenged by third parties. Generic products may be launched ‘at risk’ and our patents may be revoked, circumvented or found not to be infringed. Many of our products are subject to challenges by third-parties. Details of material challenges by third parties can be found in “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments and contingent liabilities” on pages 189 to 196 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 and incorporated by reference. The expiry dates shown below include granted SPC/PTE and/or Paediatric Exclusivity periods (as appropriate). In Europe, the exact SPC situation may vary by country as different Patent Offices grant SPCs at different rates. Bolded expiry dates relate to new molecular entity patents, the remaining dates relate to other patents. The expiry dates of relevant regulatory
19
data exclusivity periods are not represented in the table below. A number of our products are subject to generic competition in one or more markets.
Aggregate Product | ||||||||||||||||||||||
US | Sales Ex-US | |||||||||||||||||||||
Product Sales ($m) | ($m) | |||||||||||||||||||||
Key Marketed products |
| Description |
| US |
| China |
| EU1 |
| Japan |
| 2021 |
| 2020 |
| 2019 |
| 2021 |
| 2020 |
| 2019 |
Oncology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Calquence (acalabrutinib) |
| A selective inhibitor of Bruton’s tyrosine kinase indicated for the treatment of chronic lymphocytic leukaemia (CLL) and mantle cell lymphoma (MCL) and in development for the treatment of multiple B-cell malignancies. |
| 2026-2032, 2032-2036 |
| 2032, 2036 |
| 2032, 20362 |
| 2032 |
| 1,089 |
| 511 |
| 162 |
| 149 |
| 11 |
| 2 |
Enhertu3 (trastuzumab deruxtecan) |
| A HER2-directed antibody drug conjugate (ADC) indicated for the treatment of unresectable or metastatic HER2-positive breast cancer following two or more prior anti-HER2 based regimens, and locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma following a prior trastuzumab-based regimen. |
| 2033 |
| 2033-2035 |
| 2033-2035 |
| 4 |
| — |
| — |
| — |
| 17 |
| — |
| — |
Faslodex (fulvestrant) |
| An injectable oestrogen receptor antagonist, used for the treatment of hormone receptor positive advanced breast cancer that has progressed following treatment with prior endocrine therapy. |
| 20215 |
| expired |
| 2021 |
| 2025-2026 |
| 30 |
| 55 |
| 328 |
| 401 |
| 525 |
| 564 |
Imfinzi (durvalumab) |
| A human monoclonal antibody that blocks PD-L1 interaction with PD-1 and CD80 on T-cells, countering the tumour’s immune-evading tactics and inducing an immune response. It is currently indicated for the treatment of unresectable Stage III non-small cell lung cancer (NSCLC), extensive-stage small cell lung cancer and previously treated patients with advanced bladder cancer. |
| 2031 |
| 2030 |
| 2030 |
| 2033 |
| 1,245 |
| 1,185 |
| 1,041 |
| 1,167 |
| 857 |
| 428 |
Iressa (gefitinib) |
| An epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) that acts to block signals for cancer cell growth and survival in advanced NSCLC. |
| Expired6 |
| 2023 |
| 2023 |
| 2023 |
| 11 |
| 14 |
| 17 |
| 172 |
| 254 |
| 406 |
Koselugo (selumetinib) |
| An inhibitor of mitogen-activated protein kinases 1 and 2 (MEK1/2). MEK1/2 proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway. Both MEK and ERK are critical components of the RAS-regulated RAF-MEK-ERK pathway, which is often activated in different types of cancers. |
| 2023, 2023-2026 |
| 2023, 2026-2029 |
| 2023, 2026-2029 |
| 2023, 2023-2029 |
| 104 |
| 38 |
| — |
| 4 |
| — |
| — |
Lumoxiti (moxetumomab pasudotox-tdfk) |
| A CD22-directed cytotoxin and a first-in-class treatment in the US for adult patients with relapsed or refractory hairy cell leukaemia. |
| 2022-2024, 2031-2032 |
| 2031 |
| 2022, 2031 |
| 2031 |
| 1 |
| 1 |
| — |
| — |
| — |
| — |
Lynparza7 (olaparib) |
| An oral poly ADP-ribose polymerase (PARP) inhibitor that blocks DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair, such as mutations in BRCA1 and/or BRCA2. It is indicated for platinum-sensitive relapsed ovarian cancer, regardless of BRCA status, 1st-line maintenance treatment of BRCAmutated (BRCAm) advanced ovarian cancer, for germline BRCAm (gBRCAm) HER2-negative, metastatic breast cancer and for gBRCAm metastatic pancreatic cancer. |
| 2022-2024, 2028, 2024-2031 |
| 2021-2024, 2024-2029 |
| 2021-2029, 2024-2029 |
| 2021-2029, 2024-2034 |
| 1,087 |
| 876 |
| 626 |
| 1,261 |
| 900 |
| 572 |
Orpathys (savolitinib) |
| An oral, potent and highly selective MET TKI that blocks atypical activation of the MET receptor tyrosine kinase pathway. |
| 2030 |
| 2030 |
| 2030 |
| 2030 |
| — |
| — |
| — |
| 16 |
| — |
| — |
Tagrisso (osimertinib) |
| An EGFR-TKI indicated for the adjuvant treatment of patients with early-stage EGFR-mutated NSCLC and for locally advanced or metastatic EGFR-mutated NSCLC. |
| 2032, 2035 |
| 2032 |
| 2032, 2035 |
| 2034, 2035 |
| 1,780 |
| 1,566 |
| 1,268 |
| 3,235 |
| 2,762 |
| 1,921 |
Zoladex8 (goserelin acetate implant) |
| A luteinising hormone-releasing hormone (LHRH) agonist used to treat prostate cancer, breast cancer and certain benign gynaecological disorders. |
| 2022 |
| 2021 |
| 2021 |
| 2021 |
| 13 |
| 5 |
| 7 |
| 935 |
| 883 |
| 806 |
CVRM |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Brilinta/ Brilique (ticagrelor) |
| An oral P2Y12 platelet inhibitor for acute coronary syndromes (ACS) (ticagrelor 90mg) or continuation therapy in high-risk patients (ticagrelor 60mg) with a history of myocardial infarction (MI). An oral P2Y12 platelet inhibitor for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS) or high-risk patients with history of myocardial infarction (MI), high-risk patients with coronary artery disease (CAD) or stroke. |
| 20249, 2021-2036 |
| 202110 |
| 2024, 2021 |
| 2023-2024, 2025-2030 |
| 735 |
| 732 |
| 710 |
| 737 |
| 861 |
| 871 |
Bydureon/ Bydureon BCise (exenatide XR injectable suspension) |
| An injectable glucagon-like peptide-1 (GLP-1) receptor agonist available as a single-dose tray, a single-dose pen or auto-injector device indicated for use in adults with type-2 diabetes. |
| 2022-2028, 203111 |
| 2021-2028, 202911 |
| 2021-2028, 202911 |
| 2021-2028, 202911 |
| 321 |
| 382 |
| 459 |
| 64 |
| 66 |
| 90 |
Byetta (exenatide injection) |
| An injectable GLP-1 receptor agonist indicated for adults with type-2 diabetes. |
| expired |
| expired |
| 2021 |
| expired |
| 26 |
| 37 |
| 68 |
| 30 |
| 31 |
| 42 |
20
Aggregate Product | ||||||||||||||||||||||
US | Sales Ex-US | |||||||||||||||||||||
Product Sales ($m) | ($m) | |||||||||||||||||||||
Key Marketed products |
| Description |
| US |
| China |
| EU |
| Japan |
| 2021 |
| 2020 |
| 2019 |
| 2021 |
| 2020 |
| 2019 |
Crestor (rosuvastatin calcium) |
| A statin for dyslipidaemia and hypercholesterolaemia. |
| 2021-202212 |
| 2021 |
| expired |
| 2023 |
| 80 |
| 92 |
| 104 |
| 1,016 |
| 1,088 |
| 1,174 |
Farxiga/ Forxiga (dapagliflozin) |
| A sodium-glucose cotransporter 2 (SGLT-2 inhibitor) indicated for adult patients with type-2 diabetes or in adults with or without type-2 diabetes with heart failure with reduced ejection fraction or chronic kidney disease. |
| 2025, 2025-2040 |
| 2023, 2028 |
| 2027 |
| 2024-2025, 2028 |
| 644 |
| 456 |
| 434 |
| 1,770 |
| 1,049 |
| 748 |
Komboglyze/ Kombiglyze XR13 (saxagliptin/ metformin) |
| Combines saxagliptin and metformin as either Komboglyze – for type-2 diabetes, or Kombiglyze XR – an extended release tablet for type-2 diabetes. |
| 2023, 2025 |
| 2021, 2025 |
| 2021-2026, 2025 |
| 4 | 32 |
| 56 |
| — |
| 92 |
| 82 |
| 87 | |
Lokelma (sodium zirconium cyclosilicate) |
| An insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension, that acts as a highly selective potassium-removing agent for the treatment of hyperkalaemia. |
| 2032-2035 |
| 2033-2034 |
| 203214 |
| 2032-2037 |
| 115 |
| 57 |
| 13 |
| 60 |
| 19 |
| 1 |
Onglyza (saxagliptin) |
| An oral dipeptidyl peptidase 4 (DPP-4) inhibitor for type-2 diabetes. |
| 2023, 2028 |
| 2021, 2025 |
| 2024, 2025 |
| 4 | 56 |
| 110 |
| 230 |
| 179 |
| 222 |
| 209 | |
Roxadustat15 |
| An oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) indicated for the treatment of anaemia from chronic kidney disease. |
| 2024, 2024-2034 |
| 2024, 2024-2033 |
| 4 |
| 4 | — |
| — |
| — |
| 174 |
| — |
| — | |
Qtern (dapagliflozin/ saxagliptin) |
| A once-daily oral treatment combination of dapagliflozin and saxagliptin indicated for use in adults with type-2 diabetes. |
| 2025, 2025-2029 |
| 2023 |
| 2027 |
| 2024-2025 |
| 4 |
| 5 |
| 6 |
| 37 |
| 22 |
| 12 |
Xigduo/ Xigduo XR (dapagliflozin/ metformin) |
| Combines dapagliflozin and metformin as either Xigduo – to improve glycaemic control in adults with type-2 diabetes who are inadequately controlled on metformin alone or Xigduo XR – an extended release tablet for adults with type-2 diabetes who are inadequately controlled on metformin alone. |
| 2025, 2025-2030 |
| 2023 |
| 2028 |
| 2024-2025, 2030 |
| 88 |
| 113 |
| 103 |
| 498 |
| 340 |
| 257 |
Respiratory & Immunology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bevespi Aerosphere (glycopyrrolate/ formoterol) |
| A combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-agonist (LABA) used for the long-term maintenance treatment of airflow obstruction in COPD. |
| 2030-2031 |
| 2030 |
| 2030 |
| 2030-2034 |
| 39 |
| 44 |
| 42 |
| 15 |
| 4 |
| — |
Breztri Aerosphere (PT010) (budesonide/ glycopyrrolate/ formoterol) |
| A fixed-dose triple combination of an inhaled corticosteroid (ICS), a LAMA and a LABA, used for the long-term maintenance treatment of COPD. |
| 2030-2031 |
| 2030 |
| 2030 |
| 2030-2034 |
| 115 |
| 5 |
| — |
| 88 |
| 23 |
| 2 |
Daliresp/ Daxas (roflumilast) |
| An oral phosphodiesterase-4 inhibitor for adults with severe COPD to decrease their number of exacerbations. |
| 2023-2024 |
| 2023 |
| 2023 |
| expired |
| 207 |
| 190 |
| 184 |
| 20 |
| 27 |
| 31 |
Duaklir/Brimica16 (aclidinium/ formoterol) |
| A fixed-dose combination of a LAMA and a LABA for the maintenance treatment of COPD. |
| 2025, 2022-2029 |
| 2022-2027 |
| 2025, 2022-2029 |
| 2025, 2021-2029 |
| — |
| — |
| 3 |
| 77 |
| 69 |
| 74 |
Fasenra (benralizumab) |
| A monoclonal antibody for add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype, which directly targets and depletes eosinophils by recruiting natural killer cells and inducing apoptosis (programmed cell death). |
| 2024, 2028-2034 |
| 2021, 2028 |
| 2025, 2028-2034 |
| 2025, 2034 |
| 790 |
| 603 |
| 482 |
| 468 |
| 346 |
| 222 |
Pulmicort (budesonide) |
| An inhaled corticosteroid for maintenance treatment of asthma. |
| expired |
| expired |
| expired |
| expired |
| 72 |
| 71 |
| 110 |
| 890 |
| 925 |
| 1,356 |
Saphnelo (anifrolumab) |
| A first-in-class fully human monoclonal antibody for moderate to severe systemic lupus erythematosus (SLE) that binds to subunit 1 of the type I IFN receptor, blocking the activity of type I IFNs. Type I IFNs such as IFN-alpha, IFN-beta and IFN-kappa are cytokines involved in regulating the inflammatory pathways implicated in SLE. |
| 2025-2029, 2033-2036 |
| 2025-2029 |
| 2025-2029, 2036 |
| 2025-2029, 2033-2036 |
| 8 |
| — |
| — |
| — |
| — |
| — |
Symbicort (budesonide/ formoterol) |
| A combination of an inhaled corticosteroid and a fast-onset LABA to treat asthma and/or COPD either as Symbicort Turbuhaler or Symbicort pMDI (pressurised metered-dose inhaler). |
| 2022- 202917 |
| expired18 |
| expired18 |
| expired18 |
| 1,065 |
| 1,022 |
| 829 |
| 1,663 |
| 1,699 |
| 1,666 |
Tudorza/Eklira/ Bretaris16 (aclidinium) |
| A LAMA for the maintenance treatment of COPD. |
| 2025, 2022-2029 |
| 2022-2027 |
| 2025, 2022-2029 |
| 2025, 2021-2029 |
| 18 |
| 6 |
| 2 |
| 44 |
| 54 |
| 70 |
21
Aggregate Product | ||||||||||||||||||||||
US | Sales Ex-US | |||||||||||||||||||||
Product Sales ($m) | ($m) | |||||||||||||||||||||
Key Marketed products |
| Description |
| US |
| China |
| EU |
| Japan |
| 2021 |
| 2020 |
| 2019 |
| 2021 |
| 2020 |
| 2019 |
Rare Disease |
| |||||||||||||||||||||
Soliris (eculizumab) |
| A C5 inhibitor for the treatment of paroxysmal nocturnal haemoglobinuria, atypical haemolytic uraemic syndrome, generalised myasthenia gravis and neuromyelitis optica spectrum disorder. |
| 202719, 2025-2029 |
|
| 202720 |
| 2027, 2029 |
| 1,068 |
| — |
| — |
| 806 |
| — |
| — | |
Ultomiris (ravulizumab) |
| A long-acting C5 inhibitor for the treatment of paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome. |
| 2035, 2036-2042 |
| 2035, 2036-2042 |
| 2035, 2036-2042 |
| 2035, 2036-2042 |
| 381 |
| — |
| — |
| 307 |
| — |
| — |
Strensiq (asfotase alfa) |
| A targeted enzyme replacement therapy for patients with hypophosphatasia. |
| 2025-2029, 2035-2038 |
|
| 2025-2031, 2036 |
| 2028, 2035-2036 |
| 297 |
| — |
| — |
| 81 |
| — |
| — | |
Kanuma (sebelipase alfa) |
| A recombinant form of the human LAL enzyme, the enzyme replacement therapy is for the treatment of lysosomal acid lipase deficiency. |
| 2031 |
| 2031 |
| 2031, 2026-2037 |
| 2031 |
| 32 |
| — |
| — |
| 30 |
| — |
| — |
Andexxa/ Ondexxya (andexanet alfa) |
| A factor Xa inhibitor reversal agent. |
| 2028, 2030-2037 |
| 2028, 2030-2035 |
| 2028, 2030-2037 |
| 2028, 2030-2035 |
| 50 |
| — |
| — |
| 18 |
| — |
| — |
Other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fluenz Tetra/ FluMist Quadrivalent (live attenuated influenza vaccine) |
| A live attenuated vaccine indicated for active immunisation for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. |
| 2025-2026 |
| 2025 |
| 2025 |
| 202521 |
| 27 |
| 70 |
| 20 |
| 226 |
| 225 |
| 93 |
Linzess (linaclotide) |
| A guanylate cyclase-C agonist for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. |
| 4 |
| 2024, 2029 |
| 4 |
| 4 |
| — |
| — |
| — |
| — |
| — |
| — |
Nexium23 (esomeprazole) |
| A proton pump inhibitor used to treat acid-related diseases. |
| expired |
| expired |
| expired |
| expired |
| 128 |
| 169 |
| 218 |
| 1,198 |
| 1,323 |
| 1,265 |
Synagis (palivizumab) |
| A humanised mAb used to prevent serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in paediatric patients at high risk of acquiring RSV disease. |
| 202322 |
| expired |
| 2023 |
| 2023 |
| 23 |
| 47 |
| 46 |
| 387 |
| 325 |
| 312 |
Vaxzevria (ChAdOx1-S Recombinant) |
| An adenoviral vector vaccine, based on a weakened version of the common cold virus, for active immunisation against COVID-19. |
| 2032 |
| 2032 |
| 2032 |
| 2032 |
| 64 |
| — |
| — |
| 3,853 |
| 2 |
| — |
Evusheld (tixagevimab co-packaged withcilgavimab) |
| A combination of two long-acting antibodies, developed for the prevention and treatment of COVID-19. |
| — |
| — |
| — |
| 85 |
| — |
| — | ||||||||
Date represents expiry of a pending SPC/PTE and/or Paediatric Exclusivity period.
| 1 | Expiry in major EU markets, which includes the UK. |
| 2 | The patent is the subject of a pending opposition proceeding at the European Patent Office (EPO). |
| 3 | AstraZeneca has recorded $193 million of Collaboration Revenue in relation to this Product in 2021 as set out in “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” included as Exhibit 15.1 to this Form 20-F dated and submitted on February 22, 2022, and recorded $94 million of Collaboration Revenue in relation to this Product in 2020. |
| 4 | AstraZeneca does not have commercialisation rights. |
| 5 | Settled with various generic companies for licensed entry dates of 25 March 2019 or later. |
| 6 | In the US, Iressa has seven years’ Orphan Drug exclusivity to 13 July 2022. |
| 7 | In addition to any product sales, AstraZeneca has also recorded $400 million of Collaboration Revenue in relation to this Product in 2021 as set out in “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” included as Exhibit 15.1 to this Form 20-F dated and submitted on February 22, 2022, and $460 million of Collaboration Revenue in relation to this Product in 2020. |
| 8 | Rights licensed to TerSera in the US. In addition to any product sales, AstraZeneca has also recorded $35 million of Collaboration Revenue in relation to this Product in 2020 as set out in “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” included as Exhibit 15.1 to this Form 20-F dated and submitted on February 22, 2022. |
22
| 9 | Separate settlements with ANDA challengers for a licensed entry date corresponding to the expiry of US Patent No. RE46,276, subject to regulatory approval. |
| 10 | The patent was invalidated during invalidation proceedings at the CNIPA. The patentee has appealed that decision. |
| 11 | Patent expiry date relates to BCise. |
| 12 | A settlement agreement in the US permitted Watson Laboratories, Inc. and Actavis, Inc. (together, Watson) to begin selling its generic version of Crestor and its rosuvastatin zinc product from 2 May 2016. |
| 13 | Komboglyze/Kombiglyze XR revenue is included in the Onglyza revenue figure. |
| 14 | The patent is the subject of a pending opposition proceeding at the EPO. The patentee successfully defended the patent in that proceeding, but the opponents have appealed. |
| 15 | AstraZeneca has recorded $6 million of Collaboration Revenue in relation to this Product in 2021 as set out in “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” included as Exhibit 15.1 to this Form 20-F dated and submitted on February 22, 2022, and recorded $30 million of Collaboration Revenue in relation to this Product in 2020. |
| 16 | Rights to Duaklir/Brimica and Tudorza/Eklira/Bretaris sold to Covis Pharma GmbH. |
| 17 | Patent expiry information relates to the Symbicort pMDI product, including any granted Paediatric Exclusivity term. |
| 18 | Patent expiry information relates to the Symbicort Turbuhaler product. |
| 19 | Settled with biosimilar manufacturer Amgen for a licensed entry date of March 2025, or later, subject to regulatory approval. |
| 20 | The patent was revoked during opposition proceedings at the EPO. The patentee has appealed that decision. |
| 21 | Rights licensed to Daiichi Sankyo Company, Ltd. |
| 22 | Rights sold to Swedish Orphan Biovitrum AB (publ). |
| 23 | AstraZeneca has recorded $75m of Collaboration Revenue in relation to this Product in 2021 as set out in “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” included as Exhibit 15.1 to this Form 20-F dated and submitted on February 22, 2022. |
23
Geographical Review
This section Item 4—“Information on the Company— Business Overview—Geographical Review” should be read in conjunction with Item 5—“Operating and Financial Review and Prospects—Operating Results” below.
World |
| Emerging Markets |
| U.S. |
| Europe |
| Established ROW |
| ||||||||||||||||||||
2021 |
| Sales $m |
| Actual | % | CER | % | Sales $m |
| Actual | % | CER | % | Sales $m | Actual | % | Sales $m | Actual | % | CER | % | Sales $m |
| Actual | % | CER | % | ||
Oncology: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Tagrisso |
| 5,015 |
| 16 |
| 13 |
| 1,336 |
| 11 |
| 6 |
| 1,780 |
| 14 |
| 986 |
| 32 |
| 25 |
| 913 |
| 13 |
| 14 | |
Imfinzi |
| 2,412 |
| 18 |
| 16 |
| 277 |
| 76 |
| 68 |
| 1,245 |
| 5 |
| 485 |
| 31 |
| 25 |
| 405 |
| 23 |
| 23 | |
Lynparza |
| 2,348 |
| 32 |
| 30 |
| 384 |
| 45 |
| 41 |
| 1,087 |
| 24 |
| 618 |
| 42 |
| 35 |
| 259 |
| 29 |
| 28 | |
Calquence |
| 1,238 |
| n/m |
| n/m |
| 20 |
| n/m |
| n/m |
| 1,089 |
| n/m |
| 111 |
| n/m |
| n/m |
| 18 |
| n/m |
| n/m | |
Koselugo |
| 108 |
| n/m |
| n/m |
| 1 |
| n/m |
| n/m |
| 104 |
| n/m |
| 3 |
| n/m |
| n/m |
| — |
| — |
| — | |
Enhertu |
| 17 |
| n/m |
| n/m |
| 12 |
| n/m |
| n/m |
| — |
| — |
| 4 |
| n/m |
| n/m |
| 1 |
| n/m |
| n/m | |
Orpathys |
| 16 |
| n/m |
| n/m |
| 16 |
| n/m |
| n/m |
| — |
| — |
| — |
| — |
| — |
| — |
| — |
| — | |
Zoladex |
| 948 |
| 7 |
| 3 |
| 619 |
| 10 |
| 5 |
| 13 |
| n/m |
| 147 |
| 5 |
| (1) |
| 169 |
| (7) |
| (7) | |
Faslodex |
| 431 |
| (26) |
| (27) |
| 167 |
| (8) |
| (10) |
| 30 |
| (46) |
| 113 |
| (49) |
| (52) |
| 121 |
| (2) |
| (1) | |
Iressa |
| 183 |
| (32) |
| (35) |
| 151 |
| (31) |
| (35) |
| 11 |
| (23) |
| 5 |
| (58) |
| (60) |
| 16 |
| (26) |
| (26) | |
Casodex |
| 143 |
| (17) |
| (21) |
| 105 |
| (21) |
| (26) |
| — |
| — |
| 3 |
| (3) |
| 6 |
| 35 |
| (3) |
| (3) | |
Arimidex |
| 139 |
| (25) |
| (27) |
| 106 |
| (28) |
| (31) |
| — |
| — |
| 4 |
| 5 |
| 7 |
| 29 |
| (15) |
| (14) | |
Others |
| 50 |
| 1 |
| (1) |
| 29 |
| 3 |
| 1 |
| — |
| — |
| 5 |
| 51 |
| 43 |
| 16 |
| (16) |
| (15) | |
Total Oncology |
| 13,048 |
| 20 |
| 18 |
| 3,223 |
| 11 |
| 6 |
| 5,359 |
| 26 |
| 2,484 |
| 28 |
| 22 |
| 1,982 |
| 13 |
| 13 | |
BioPharmaceuticals: CVRM |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Farxiga |
| 3,000 |
| 53 |
| 49 |
| 1,195 |
| 74 |
| 70 |
| 732 |
| 29 |
| 810 |
| 60 |
| 52 |
| 263 |
| 34 |
| 31 | |
Brilinta |
| 1,472 |
| (8) |
| (10) |
| 328 |
| (29) |
| (31) |
| 735 |
| 1 |
| 346 |
| 1 |
| (4) |
| 63 |
| 8 |
| (1) | |
Bydureon |
| 385 |
| (14) |
| (15) |
| 3 |
| (25) |
| (26) |
| 321 |
| (16) |
| 55 |
| 5 |
| — |
| 6 |
| (40) |
| (44) | |
Onglyza |
| 360 |
| (23) |
| (26) |
| 179 |
| (11) |
| (14) |
| 88 |
| (47) |
| 61 |
| 5 |
| (1) |
| 32 |
| (29) |
| (33) | |
Byetta |
| 55 |
| (19) |
| (19) |
| 12 |
| 61 |
| 75 |
| 26 |
| (31) |
| 11 |
| (20) |
| (25) |
| 6 |
| (36) |
| (38) | |
Other diabetes |
| 59 |
| 26 |
| 24 |
| 18 |
| n/m |
| n/m |
| 22 |
| (12) |
| 17 |
| 35 |
| 31 |
| 2 |
| 11 |
| 12 | |
Lokelma |
| 175 |
| n/m |
| n/m |
| 3 |
| (44) |
| (48) |
| 115 |
| n/m |
| 13 |
| n/m |
| n/m |
| 44 |
| n/m |
| n/m | |
Roxadustat |
| 174 |
| n/m |
| n/m |
| 174 |
| n/m |
| n/m |
| — |
| — |
| — |
| — |
| — |
| — |
| — |
| — | |
Crestor |
| 1,096 |
| (7) |
| (10) |
| 775 |
| 4 |
| — |
| 80 |
| (13) |
| 52 |
| (60) |
| (62) |
| 189 |
| (11) |
| (10) | |
Seloken/Toprol-XL |
| 951 |
| 16 |
| 10 |
| 928 |
| 19 |
| 13 |
| 1 |
| (89) |
| 11 |
| (33) |
| (33) |
| 11 |
| 9 |
| (3) | |
Atacand |
| 97 |
| (60) |
| (60) |
| 28 |
| (84) |
| (84) |
| 4 |
| (65) |
| 65 |
| 87 |
| 86 |
| — |
| n/m |
| n/m | |
Others |
| 196 |
| 3 |
| (2) |
| 137 |
| 9 |
| 3 |
| — |
| — |
| 53 |
| (7) |
| (8) |
| 6 |
| (21) |
| (25) | |
Total CVRM |
| 8,020 |
| 13 |
| 10 |
| 3,780 |
| 18 |
| 14 |
| 2,124 |
| 2 |
| 1,494 |
| 22 |
| 16 |
| 622 |
| 7 |
| 5 | |
BioPharmaceuticals: Respiratory & Immunology |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Symbicort |
| 2,728 |
| — |
| (2) |
| 609 |
| 7 |
| 4 |
| 1,065 |
| 4 |
| 670 |
| (3) |
| (8) |
| 384 |
| (12) |
| (17) | |
Fasenra |
| 1,258 |
| 33 |
| 31 |
| 20 |
| 67 |
| 67 |
| 790 |
| 31 |
| 286 |
| 41 |
| 34 |
| 162 |
| 24 |
| 22 | |
Pulmicort |
| 962 |
| (3) |
| (8) |
| 770 |
| (3) |
| (9) |
| 72 |
| 1 |
| 73 |
| — |
| (5) |
| 47 |
| (13) |
| (15) | |
Daliresp |
| 227 |
| 5 |
| 4 |
| 4 |
| — |
| (2) |
| 207 |
| 9 |
| 15 |
| (32) |
| (37) |
| 1 |
| (3) |
| (10) | |
Breztri |
| 203 |
| n/m |
| n/m |
| 55 |
| n/m |
| n/m |
| 115 |
| n/m |
| 7 |
| n/m |
| n/m |
| 26 |
| n/m |
| n/m | |
Bevespi |
| 54 |
| 12 |
| 12 |
| 4 |
| n/m |
| n/m |
| 39 |
| (11) |
| 11 |
| n/m |
| n/m |
| — |
| — |
| — | |
Saphnelo |
| 8 |
| n/m |
| n/m |
| — |
| — |
| — |
| 8 |
| — |
| — |
| — |
| — |
| — |
| — |
| — | |
Others |
| 594 |
| 49 |
| 42 |
| 287 |
| 41 |
| 32 |
| 108 |
| n/m |
| 185 |
| 5 |
| — |
| 14 |
| 1 |
| (6) | |
Total Respiratory & Immunology |
| 6,034 |
| 13 |
| 9 |
| 1,749 |
| 9 |
| 4 |
| 2,404 |
| 24 |
| 1,247 |
| 6 |
| 1 |
| 634 |
| (2) |
| (5) | |
Rare Disease*: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Soliris* |
| 1,874 |
| 1 |
| 2 |
| 170 |
| 1 |
| 8 |
| 1,068 |
| 4 |
| 439 |
| (8) |
| (7) |
| 197 |
| 8 |
| 11 | |
Ultomiris* |
| 688 |
| 27 |
| 29 |
| 9 |
| n/m |
| n/m |
| 381 |
| 20 |
| 169 |
| 73 |
| 74 |
| 129 |
| 4 |
| 11 | |
Strensiq* |
| 378 |
| 13 |
| 13 |
| 10 |
| 81 |
| 78 |
| 297 |
| 13 |
| 36 |
| 2 |
| 3 |
| 35 |
| 9 |
| 14 | |
Andexxa* |
| 68 |
| (3) |
| (3) |
| — |
| — |
| — |
| 50 |
| (21) |
| 18 |
| 7 |
| 6 |
| — |
| — |
| — | |
Kanuma* |
| 62 |
| 20 |
| 21 |
| 7 |
| n/m |
| n/m |
| 32 |
| 13 |
| 20 |
| 7 |
| 9 |
| 3 |
| 14 |
| 25 | |
Total Rare Disease |
| 3,070 |
| 8 |
| 9 |
| 196 |
| 11 |
| 18 |
| 1,828 |
| 8 |
| 682 |
| 7 |
| 9 |
| 364 |
| 7 |
| 11 | |
Other medicines |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Nexium |
| 1,326 |
| (11) |
| (12) |
| 705 |
| (7) |
| (10) |
| 128 |
| (24) |
| 62 |
| (13) |
| (18) |
| 431 |
| (13) |
| (12) | |
Synagis |
| 410 |
| 10 |
| 13 |
| 35 |
| — |
| — |
| 23 |
| (51) |
| 203 |
| (38) |
| (37) |
| 149 |
| — |
| — | |
Flumist |
| 253 |
| (14) |
| (17) |
| 2 |
| 15 |
| 2 |
| 27 |
| (62) |
| 222 |
| 1 |
| (2) |
| 2 |
| (50) |
| (53) | |
Losec/Prilosec |
| 180 |
| (2) |
| (7) |
| 152 |
| — |
| (7) |
| 1 |
| (89) |
| 26 |
| 32 |
| 31 |
| 1 |
| (82) |
| (72) | |
Seroquel XR/IR |
| 92 |
| (21) |
| (20) |
| 46 |
| (17) |
| (15) |
| 12 |
| (30) |
| 29 |
| 2 |
| 2 |
| 5 |
| (71) |
| (67) | |
Others |
| 106 |
| (16) |
| (19) |
| 14 |
| n/m |
| n/m |
| 30 |
| (45) |
| 54 |
| (5) |
| (9) |
| 8 |
| (13) |
| (19) | |
Total Other medicines |
| 2,367 |
| (8) |
| (10) |
| 954 |
| (2) |
| (5) |
| 221 |
| (39) |
| 596 |
| (17) |
| (19) |
| 596 |
| 12 |
| 15 | |
COVID-19 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Vaxzevria |
| 3,917 |
| n/m |
| n/m |
| 2,240 |
| n/m |
| n/m |
| 64 |
| n/m |
| 1,035 |
| n/m |
| n/m |
| 578 |
| n/m |
| n/m | |
Evusheld |
| 85 |
| n/m |
| n/m |
| 19 |
| n/m |
| n/m |
| — |
| — |
| 66 |
| n/m |
| n/m |
| — |
| — |
| — | |
Total COVID-19 |
| 4,002 |
| n/m |
| n/m |
| 2,259 |
| n/m |
| n/m |
| 64 |
| n/m |
| 1,101 |
| n/m |
| n/m |
| 578 |
| n/m |
| n/m | |
Total Product Sales |
| 36,541 |
| 41 |
| 38 |
| 12,161 |
| 40 |
| 36 |
| 12,000 |
| 39 |
| 7,604 |
| 50 |
| 44 |
| 4,776 |
| 36 |
| 36 | |
24
*Growth rates on Rare Disease medicines have been calculated by comparing post-acquisition revenues from 21 July 2021 with the corresponding prior year pre-acquisition revenues previously published by Alexion adjusted pro rata to match the post-acquisition period.
World |
| Emerging Markets |
| U.S. |
| Europe |
| Established ROW |
| ||||||||||||||||||||
2020 |
| Sales $m |
| Actual | % | CER | % | Sales $m |
| Actual | % | CER | % | Sales $m |
| Actual | % | Sales $m |
| Actual | % | CER | % | Sales $m |
| Actual | % | CER | % |
Oncology: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tagrisso |
| 4,328 |
| 36 |
| 36 |
| 1,208 |
| 59 |
| 63 |
| 1,566 |
| 24 |
| 748 |
| 58 |
| 56 |
| 806 |
| 18 |
| 16 |
|
Imfinzi |
| 2,042 |
| 39 |
| 39 |
| 158 |
| n/m |
| n/m |
| 1,185 |
| 14 |
| 370 |
| n/m |
| n/m |
| 329 |
| 51 |
| 49 |
|
Lynparza |
| 1,776 |
| 48 |
| 49 |
| 264 |
| 98 |
| n/m |
| 876 |
| 40 |
| 435 |
| 52 |
| 51 |
| 201 |
| 32 |
| 32 |
|
Calquence |
| 522 |
| n/m |
| n/m |
| 6 |
| n/m |
| n/m |
| 511 |
| n/m |
| 2 |
| n/m |
| n/m |
| 3 |
| n/m |
| n/m |
|
Koselugo |
| 38 |
| n/m |
| n/m |
| — |
| — |
| — |
| 38 |
| n/m |
| — |
| — |
| — |
| — |
| — |
| — |
|
Zoladex |
| 888 |
| 9 |
| 13 |
| 561 |
| 14 |
| 20 |
| 5 |
| (22) |
| 140 |
| 4 |
| 4 |
| 182 |
| 1 |
| 1 |
|
Faslodex |
| 580 |
| (35) |
| (34) |
| 180 |
| (9) |
| (4) |
| 55 |
| (83) |
| 221 |
| (3) |
| (3) |
| 124 |
| (10) |
| (11) |
|
Iressa |
| 268 |
| (37) |
| (36) |
| 221 |
| (23) |
| (22) |
| 14 |
| (21) |
| 12 |
| (82) |
| (82) |
| 21 |
| (57) |
| (57) |
|
Arimidex |
| 185 |
| (18) |
| (16) |
| 147 |
| (3) |
| 1 |
| — |
| — |
| 3 |
| (88) |
| (88) |
| 35 |
| (23) |
| (24) |
|
Casodex |
| 172 |
| (14) |
| (14) |
| 133 |
| 4 |
| 6 |
| — |
| — |
| 3 |
| (83) |
| (83) |
| 36 |
| (37) |
| (38) |
|
Others |
| 51 |
| (47) |
| (46) |
| 28 |
| (1) |
| 1 |
| — |
| — |
| 4 |
| (41) |
| (40) |
| 19 |
| (69) |
| (69) |
|
Total Oncology |
| 10,850 |
| 25 |
| 26 |
| 2,906 |
| 31 |
| 36 |
| 4,250 |
| 23 |
| 1,938 |
| 36 |
| 35 |
| 1,756 |
| 11 |
| 10 |
|
CVRM: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Farxiga |
| 1,959 |
| 27 |
| 30 |
| 686 |
| 46 |
| 55 |
| 569 |
| 6 |
| 507 |
| 36 |
| 35 |
| 197 |
| 21 |
| 21 |
|
Brilinta |
| 1,593 |
| 1 |
| 2 |
| 461 |
| — |
| 4 |
| 732 |
| 3 |
| 342 |
| (3) |
| (3) |
| 58 |
| — |
| 2 |
|
Onglyza |
| 470 |
| (11) |
| (10) |
| 201 |
| 14 |
| 18 |
| 166 |
| (28) |
| 58 |
| (16) |
| (17) |
| 45 |
| (12) |
| (11) |
|
Bydureon |
| 448 |
| (18) |
| (18) |
| 4 |
| (62) |
| (59) |
| 382 |
| (17) |
| 53 |
| (20) |
| (20) |
| 9 |
| (32) |
| (31) |
|
Byetta |
| 68 |
| (37) |
| (36) |
| 8 |
| (35) |
| (23) |
| 37 |
| (45) |
| 14 |
| (24) |
| (24) |
| 9 |
| (18) |
| (17) |
|
Other diabetes |
| 47 |
| (10) |
| (10) |
| 7 |
| n/m |
| n/m |
| 25 |
| (37) |
| 13 |
| 38 |
| 38 |
| 2 |
| 26 |
| 28 |
|
Lokelma |
| 76 |
| n/m |
| n/m |
| 5 |
| n/m |
| n/m |
| 57 |
| n/m |
| 4 |
| n/m |
| n/m |
| 10 |
| n/m |
| n/m |
|
Crestor |
| 1,180 |
| (8) |
| (7) |
| 748 |
| (7) |
| (5) |
| 92 |
| (11) |
| 129 |
| (13) |
| (15) |
| 211 |
| (4) |
| (5) |
|
Seloken/Toprol-XL |
| 821 |
| 8 |
| 12 |
| 782 |
| 14 |
| 18 |
| 13 |
| (66) |
| 16 |
| (35) |
| (35) |
| 10 |
| (11) |
| (10) |
|
Atacand |
| 243 |
| 10 |
| 15 |
| 175 |
| 9 |
| 17 |
| 10 |
| (12) |
| 35 |
| 17 |
| 17 |
| 23 |
| 15 |
| 15 |
|
Others |
| 191 |
| (30) |
| (30) |
| 126 |
| (35) |
| (34) |
| — |
| — |
| 57 |
| (5) |
| (4) |
| 8 |
| (60) |
| (61) |
|
Total CVRM |
| 7,096 |
| 3 |
| 5 |
| 3,203 |
| 8 |
| 12 |
| 2,083 |
| (6) |
| 1,228 |
| 7 |
| 6 |
| 582 |
| 2 |
| 2 |
|
Respiratory & Immunology: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Symbicort |
| 2,721 |
| 9 |
| 10 |
| 567 |
| 4 |
| 9 |
| 1,022 |
| 23 |
| 694 |
| 2 |
| 2 |
| 438 |
| (1) |
| — |
|
Pulmicort |
| 996 |
| (32) |
| (32) |
| 798 |
| (33) |
| (33) |
| 71 |
| (35) |
| 73 |
| (10) |
| (10) |
| 54 |
| (37) |
| (37) |
|
Fasenra |
| 949 |
| 35 |
| 34 |
| 12 |
| n/m |
| n/m |
| 603 |
| 25 |
| 203 |
| 72 |
| 70 |
| 131 |
| 33 |
| 32 |
|
Daliresp/Daxas |
| 217 |
| 1 |
| 1 |
| 4 |
| (9) |
| (8) |
| 190 |
| 3 |
| 22 |
| (14) |
| (13) |
| 1 |
| (10) |
| (8) |
|
Bevespi |
| 48 |
| 16 |
| 15 |
| 1 |
| n/m |
| n/m |
| 44 |
| 7 |
| 3 |
| n/m |
| n/m |
| — |
| — |
| — |
|
Breztri |
| 28 |
| n/m |
| n/m |
| 14 |
| n/m |
| n/m |
| 5 |
| n/m |
| — |
| — |
| — |
| 9 |
| n/m |
| n/m |
|
Others |
| 398 |
| (15) |
| (15) |
| 203 |
| (15) |
| (16) |
| 6 |
| (12) |
| 176 |
| (14) |
| (15) |
| 13 |
| (15) |
| (7) |
|
Total Respiratory & Immunology |
| 5,357 |
| (1) |
| — |
| 1,599 |
| (20) |
| (18) |
| 1,941 |
| 17 |
| 1,171 |
| 6 |
| 5 |
| 646 |
| — |
| 1 |
|
Other: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nexium |
| 1,492 |
| 1 |
| 2 |
| 757 |
| 1 |
| 4 |
| 169 |
| (22) |
| 71 |
| 12 |
| 10 |
| 495 |
| 9 |
| 8 |
|
Synagis |
| 372 |
| 4 |
| 4 |
| — |
| — |
| — |
| 47 |
| 2 |
| 325 |
| 4 |
| 4 |
| — |
| — |
| — |
|
Flumist |
| 295 |
| n/m |
| n/m |
| 1 |
| n/m |
| n/m |
| 70 |
| n/m |
| 219 |
| n/m |
| n/m |
| 5 |
| n/m |
| n/m |
|
Losec/Prilosec |
| 183 |
| (30) |
| (30) |
| 152 |
| (15) |
| (14) |
| 6 |
| (44) |
| 20 |
| (59) |
| (59) |
| 5 |
| (78) |
| (79) |
|
Seroquel XR/IR |
| 117 |
| (39) |
| (37) |
| 55 |
| 11 |
| 14 |
| 17 |
| (48) |
| 29 |
| (67) |
| (67) |
| 16 |
| (19) |
| (18) |
|
Others |
| 128 |
| (33) |
| (34) |
| 6 |
| (51) |
| (44) |
| 55 |
| (50) |
| 58 |
| (7) |
| (8) |
| 9 |
| 6 |
| (5) |
|
Total Other Medicines |
| 2,587 |
| (1) |
| n/m |
| 971 |
| (2) |
| 1 |
| 364 |
| (17) |
| 722 |
| 8 |
| 7 |
| 530 |
| 5 |
| 3 |
|
Total Product Sales |
| 25,890 |
| 10 |
| 11 |
| 8,679 |
| 6 |
| 10 |
| 8,638 |
| 12 |
| 5,059 |
| 16 |
| 15 |
| 3,514 |
| 6 |
| 6 |
|
25
World | Emerging Markets | U.S. | Europe | Established ROW |
| ||||||||||||||||||||||||
2019 |
| Sales $m |
| Actual | % | CER | % | Sales $m |
| Actual | % | CER | % | Sales $m |
| Actual | % | Sales $m |
| Actual | % | CER | % | Sales $m |
| Actual | % | CER | % |
Oncology: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Tagrisso |
| 3,189 |
| 71 |
| 74 |
| 762 |
| n/m |
| n/m |
| 1,268 |
| 46 |
| 474 |
| 51 |
| 59 |
| 685 |
| n/m |
| n/m | |
Imfinzi |
| 1,469 |
| n/m |
| n/m |
| 30 |
| n/m |
| n/m |
| 1,041 |
| 85 |
| 179 |
| n/m |
| n/m |
| 219 |
| n/m |
| n/m | |
Lynparza |
| 1,198 |
| 85 |
| 89 |
| 133 |
| n/m |
| n/m |
| 626 |
| 81 |
| 287 |
| 51 |
| 59 |
| 152 |
| n/m |
| n/m | |
Calquence |
| 164 |
| n/m |
| n/m |
| 2 |
| n/m |
| n/m |
| 162 |
| n/m |
| — |
| — |
| — |
| — |
| — |
| — | |
Faslodex |
| 892 |
| (13) |
| (11) |
| 198 |
| 29 |
| 36 |
| 328 |
| (39) |
| 229 |
| 3 |
| 9 |
| 137 |
| 19 |
| 17 | |
Zoladex |
| 813 |
| 8 |
| 13 |
| 492 |
| 20 |
| 28 |
| 7 |
| (17) |
| 135 |
| 2 |
| 7 |
| 179 |
| (11) |
| (10) | |
Iressa |
| 423 |
| (18) |
| (15) |
| 286 |
| — |
| 4 |
| 17 |
| (33) |
| 70 |
| (36) |
| (32) |
| 50 |
| (49) |
| (49) | |
Arimidex |
| 225 |
| 6 |
| 11 |
| 152 |
| 15 |
| 21 |
| — |
| — |
| 28 |
| (8) |
| (3) |
| 45 |
| (9) |
| (9) | |
Casodex |
| 200 |
| — |
| 3 |
| 127 |
| 13 |
| 19 |
| — |
| (88) |
| 16 |
| (20) |
| (15) |
| 57 |
| (15) |
| (15) | |
Others |
| 94 |
| (18) |
| (17) |
| 29 |
| (6) |
| (3) |
| — |
| — |
| 5 |
| (24) |
| (19) |
| 60 |
| (21) |
| (22) | |
Total Oncology |
| 8,667 |
| 44 |
| 47 |
| 2,211 |
| 45 |
| 52 |
| 3,449 |
| 43 |
| 1,423 |
| 35 |
| 42 |
| 1,584 |
| 53 |
| 52 | |
CVRM: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Farxiga |
| 1,543 |
| 11 |
| 14 |
| 471 |
| 40 |
| 48 |
| 537 |
| (9) |
| 373 |
| 18 |
| 25 |
| 162 |
| 9 |
| 10 | |
Brilinta |
| 1,581 |
| 20 |
| 23 |
| 462 |
| 42 |
| 49 |
| 710 |
| 21 |
| 351 |
| 1 |
| 7 |
| 58 |
| (1) |
| 3 | |
Bydureon |
| 549 |
| (6) |
| (5) |
| 11 |
| 34 |
| 39 |
| 459 |
| (3) |
| 66 |
| (19) |
| (14) |
| 13 |
| (32) |
| (28) | |
Onglyza |
| 527 |
| (3) |
| — |
| 176 |
| 3 |
| 9 |
| 230 |
| 3 |
| 70 |
| (22) |
| (17) |
| 51 |
| (14) |
| (12) | |
Byetta |
| 110 |
| (13) |
| (11) |
| 12 |
| 47 |
| 60 |
| 68 |
| (9) |
| 19 |
| (35) |
| (31) |
| 11 |
| (24) |
| (20) | |
Other diabetes |
| 52 |
| 33 |
| 35 |
| 1 |
| n/m |
| n/m |
| 40 |
| 18 |
| 9 |
| 88 |
| n/m |
| 2 |
| 23 |
| 33 | |
Lokelma |
| 14 |
| n/m |
| n/m |
| — |
| — |
| — |
| 13 |
| n/m |
| 1 |
| n/m |
| n/m |
| — |
| — |
| — | |
Crestor |
| 1,278 |
| (11) |
| (8) |
| 806 |
| (4) |
| — |
| 104 |
| (39) |
| 148 |
| (27) |
| (23) |
| 220 |
| — |
| 1 | |
Seloken/Toprol-XL |
| 760 |
| 7 |
| 12 |
| 686 |
| 7 |
| 13 |
| 37 |
| (5) |
| 25 |
| 31 |
| 31 |
| 12 |
| (11) |
| (8) | |
Atacand |
| 221 |
| (15) |
| (11) |
| 160 |
| 2 |
| 7 |
| 12 |
| (11) |
| 30 |
| (57) |
| (57) |
| 19 |
| 1 |
| 7 | |
Others |
| 271 |
| (9) |
| (6) |
| 193 |
| (6) |
| (3) |
| (1) |
| (91) |
| 59 |
| (16) |
| (12) |
| 20 |
| (16) |
| (16) | |
Total CVRM |
| 6,906 |
| 3 |
| 6 |
| 2,978 |
| 10 |
| 16 |
| 2,209 |
| n/m |
| 1,151 |
| (6) |
| (1) |
| 568 |
| (2) |
| n/m | |
Respiratory: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Symbicort |
| 2,495 |
| (3) |
| — |
| 547 |
| 11 |
| 17 |
| 829 |
| (4) |
| 678 |
| (12) |
| (7) |
| 441 |
| 2 |
| 3 | |
Pulmicort |
| 1,466 |
| 14 |
| 18 |
| 1,190 |
| 20 |
| 24 |
| 110 |
| (5) |
| 81 |
| (10) |
| (4) |
| 85 |
| 1 |
| 1 | |
Fasenra |
| 704 |
| n/m |
| n/m |
| 5 |
| n/m |
| n/m |
| 482 |
| n/m |
| 118 |
| n/m |
| n/m |
| 99 |
| n/m |
| n/m | |
Daliresp/Daxas |
| 215 |
| 14 |
| 15 |
| 4 |
| (18) |
| (13) |
| 184 |
| 19 |
| 26 |
| (8) |
| (3) |
| 1 |
| 32 |
| 35 | |
Duaklir |
| 77 |
| (19) |
| (15) |
| 1 |
| 44 |
| 49 |
| 3 |
| n/m |
| 71 |
| (22) |
| (17) |
| 2 |
| (65) |
| (64) | |
Bevespi |
| 42 |
| 26 |
| 26 |
| — |
| — |
| — |
| 42 |
| 25 |
| — |
| — |
| — |
| — |
| — |
| — | |
Breztri |
| 2 |
| n/m |
| n/m |
| — |
| — |
| — |
| — |
| — |
| — |
| — |
| — |
| 2 |
| n/m |
| n/m | |
Others |
| 390 |
| (13) |
| (9) |
| 240 |
| 62 |
| 70 |
| 3 |
| (88) |
| 133 |
| (38) |
| (35) |
| 14 |
| (74) |
| (73) | |
Total Respiratory |
| 5,391 |
| 10 |
| 13 |
| 1,987 |
| 21 |
| 27 |
| 1,653 |
| 17 |
| 1,107 |
| (10) |
| (5) |
| 644 |
| 4 |
| 4 | |
Other: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Nexium |
| 1,483 |
| (13) |
| (11) |
| 748 |
| 8 |
| 14 |
| 218 |
| (29) |
| 63 |
| (73) |
| (72) |
| 454 |
| (4) |
| (4) | |
Synagis |
| 358 |
| (46) |
| (46) |
| — |
| (100) |
| (100) |
| 46 |
| (84) |
| 312 |
| (17) |
| (17) |
| — |
| — |
| — | |
Losec/Prilosec |
| 263 |
| (3) |
| 1 |
| 179 |
| 11 |
| 17 |
| 10 |
| 43 |
| 49 |
| (30) |
| (26) |
| 25 |
| (27) |
| (26) | |
Seroquel XR/IR |
| 191 |
| (47) |
| (46) |
| 50 |
| (58) |
| (57) |
| 34 |
| (69) |
| 88 |
| (18) |
| (14) |
| 19 |
| (30) |
| (30) | |
Others |
| 306 |
| (23) |
| (20) |
| 12 |
| (77) |
| (81) |
| 128 |
| (4) |
| 157 |
| (1) |
| 2 |
| 9 |
| (84) |
| (67) | |
Total Other Medicines |
| 2,601 |
| (24) |
| (21) |
| 989 |
| (3) |
| 1 |
| 436 |
| (48) |
| 669 |
| (29) |
| (28) |
| 507 |
| (14) |
| (12) | |
Total Product Sales |
| 23,565 |
| 12 |
| 15 |
| 8,165 |
| 18 |
| 24 |
| 7,747 |
| 13 |
| 4,350 |
| (2) |
| 2 |
| 3,303 |
| 17 |
| 18 | |
All commentary in “—Geographical Review” relates to Product Sales. The market definitions used in the geographical areas review below are defined in the Glossary on pages 224 to 227 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as Exhibit 15.1 to this Form 20-F dated and submitted on February 22, 2022.
2021 in brief
Product Sales increased by 41% (CER: 38%) in 2021 to $36,541 million (2020: $25,890 million; 2019: $23,565 million) including COVID-19 vaccine revenues. Product Sales excluding vaccines increased 26% (24% at CER) to $32,624 million. Growth was well balanced across AstraZeneca’s strategic areas of focus with double-digit growth in all major regions, including Emerging Markets, despite some headwinds in China. Following completion of the Alexion acquisition on 21 July 2021, Rare Disease medicines generated $3,070 million, growing 8% (CER: 9%) on a pro-rata basis, and contributed to 8% of AstraZeneca’s Total Product Sales.
In 2021, Product Sales in Emerging Markets increased by 40% (CER: 36%) to $12,161 million (2020: $8,679 million; 2019: $8,165 million). Excluding Vaxzevria, Product Sales in Emerging Markets increased by 14% (10% CER) in the year to $9,921 million. China sales, comprising 49% of Emerging Markets sales, increased by 12% (CER: 4%) to $5,995 million (2020: $5,345 million; 2019: $4,880 million). This contributed to 16% of Product Sales in 2021.
Ex-China Emerging Markets Product Sales increased by 85% (86% at CER) to $6,166 million (2020: $3,334 million; 2019: $3,284 million). Excluding Vaxzezria sales, Product Sales in Ex-China Emerging Markets increased by 18% in the year (CER: 19%) to $3,926 million, driven by Oncology medicines and Farxiga. Product Sales of Vaxzevria in Ex-China Emerging Markets generated a $2,240 million in the year.
Sales in the U.S. increased by 39% to $12,000 million (2020: $8,638 million; 2019: $7,747 million) driven by strong performance of Oncology and Respiratory & Immunology medicines. Sales of Rare Disease medicines in the U.S. post acquisition increased to $1,828 million, representing a pro rata increase of 8% thereby contributing to 60% of total Rare Disease sales. This is largely driven by Product Sales of Soliris.
Product Sales in Europe increased by 50% (CER: 44%) to $7,604 million (2020: $5,059 million; 2019: $4,350 million). Sales of Rare Disease medicines comprised 9% of Europe Product Sales, which grew on a pro rata basis by 7% (CER: 9%) to $682 million in 2021. Oncology sales in Europe grew by 28% (CER: 22%) to $2,484 million (2020: $1,938 million; 2019:
26
$1,423 million) and represented 33% of Europe sales, primarily driven by sales of Tagrisso, Lynparza and Imfinzi. Vaxzevria sales contributed $1,035 million, amounting to 14% of total Europe Product Sales and 26% to the total Vaxzevria sales in 2021. Excluding Vaxzevria, Product Sales in Europe grew by 30% (25% CER) to $6,568 million.
Sales in the Established ROW region increased by 36% (CER:36%) to $4,776 million (2020: $3,514 million; 2019: $3,303 million) largely driven by Tagrisso and Imfinzi. Japan, comprising 72% of total Established ROW sales, increased by 31% (CER: 35%) to $3,416 million (2020: $2,600 million; 2019: $2,548 million), underpinned by sales of Oncology. Sales in Canada, which contributed 16% of total Established ROW sales, increased by 28% (CER: 19%) to $772 million (2020: $605 million; 2019: $470 million). Other Established ROW sales increased by 90% (CER: 76%) to $588 million in the year (2020: $309 million; 2019: $286 million), largely driven by Vaxzevria.
The Group has ceased reporting New Medicines as a performance metric (Tagrisso, Imfinzi, Lynparza, Calquence, Enhertu, Koselugo, Farxiga, Brilinta, Lokelma, roxadustat, Fasenra, Bevespi and Breztri). In line with practice these medicines were reported within their respective disease areas.
2020 in brief
Product Sales increased by 10% (CER: 11%) in 2020 to $25,890 million (2019: $23,565 million) with the fourth quarter of that year being the first for many years where the Product Sales exceeded $7,000 million. The growth in Product Sales is primarily driven by solid performances of New Medicines in Emerging Markets.
Sales of New Medicines increased by 35% (CER: 36%) to $13,359 million (2019: $9,906 million) including growth in Emerging Markets of 51% (CER: 57%) to $2,814 million (2019: $1,865 million). New Medicines represented 52% of Total Product Sales (2019: 42%) globally with outstanding performances across the major therapy areas.
Sales of specialty-care medicines increased by 23% (CER: 24%) to $13,468 million (2019: $10,965 million), with a significant contribution from Emerging Markets consisting of 25% of total sales.
In 2020, Product Sales in Emerging Markets increased by 6% (CER: 10%) to $8,679 million (2019: $8,165 million). New Medicines grew by 51% (CER: 57%) to $2,814 million (2019: $1,865 million) and represented 32% (2019: 23%) of Emerging Markets sales. China sales comprised 62% of Emerging Markets sales and increased by 10% (CER: 10%) to $5,345 million (2019: $4,880 million). New Medicines, primarily driven by Tagrisso and Lynparza in Oncology and Forxiga in New CVRM delivered particularly encouraging growth and represented 30% of China Total Product Sales. Strong sales of Zoladex, Seloken and Symbicort supplemented this performance. The decline of Pulmicort in China by 36% (CER: 37%) to $648 million (2019: $1,006 million) restricted growth in the year.
Ex-China Emerging Markets Product Sales increased by 2% (10% at CER) to $3,334 million, with particularly strong performances in Russia, where it grew by 28% (42% at CER) to $314 million and ex-Brazil Latin America which was stable (growth of 18% at CER), with sales of $447 million.
Sales in the U.S. increased by 12% to $8,638 million (2019: $7,747 million). This was driven by sustained growth of New Medicines, which contributes to 72% of Product Sales, as a result of continuing growth across the Oncology and New Respiratory & Immunology therapy areas as well as Forxiga.
Product Sales in Europe increased by 16% (CER: 15%) to $5,059 million (2019: $4,350 million). Sales of New Medicines comprised 52% of Europe Product Sales, which grew by 47% (CER: 45%) to $2,614 million in 2020. Oncology sales in Europe grew by 36% (CER: 35%) to $1,938 million (2019: $1,423 million) represented 38% of Europe sales, driven by growth in Tagrisso, Imfinzi and Lynparza.
Sales in the Established ROW region increased by 6% (CER: 6%) to $3,514 million (2019: $3,303 million) driven by accelerating growth in New Medicines, which made up 50% of Product Sales in that region. Japan, comprising 74% of total Established ROW sales, increased by 2% (CER: 1%) to $2,600 million (2019: $2,548 million) and is underpinned by increased sales of Tagrisso by 16% (14% at CER) to $731 million, despite a price reduction of 15% in 2019.
2019 in brief
Product Sales increased by 12% (CER: 15%) in 2019 to $23,565 million with growth across all three therapy areas at actual and CER.
Sales of New Medicines increased by 59% (CER: 62%) to $9,906 million, including New Medicine growth in Emerging Markets of 75% (CER: 84%) to $1,865 million. New Medicines represented 42% of total Product Sales.
In 2019, Product Sales in Emerging Markets increased by 18% (CER: 24%) to $8,165 million. New Medicines represented 23% of Emerging Markets sales, up from 15% in 2018.
27
Sales of specialty-care medicines in Emerging Markets increased by 44% (CER: 52%) to $2,678 million and comprised 33% of Product Sales in that region in 2019.
China sales, comprising 60% of total Emerging Markets sales, increased by 29% (CER: 35%) to $4,880 million. New Medicines delivered particularly encouraging sales growth, representing 19% of China sales, up from 11% in 2018.
In Emerging Markets, excluding China, sales increased by 6% (CER: 12%) to $3,284 million. New Medicines represented 29% of Product Sales in 2019 increasing by 45% (CER: 53%). The performance was underpinned by strong growth with every Emerging Markets sub-region delivering growth at CER.
Sales in the U.S. increased by 13% to $7,747 million.
In Europe, sales declined by 2% (CER: increased by 2%) to $4,350 million, reflecting a strong performance by Oncology offset by the impact of a decline in Nexium and legacy Respiratory (which includes Pulmicort, Symbicort, Daliresp/Daxas and Duaklir) in 2019. Oncology sales in Europe increased by 35% (CER: 42%) to $1,423 million driven by growth in Tagrisso, Imfinzi and Lynparza, representing 33% of Europe sales. Sales of Nexium declined by 73% (CER: 72%) to $63 million and legacy Respiratory declined by 17% (CER: 13%) to $989 million reflecting declines in sales of Symbicort and Pulmicort.
Sales in the Established ROW region grew by 17% (CER: 18%) to $3,303 million.
Japan, comprising 77% of total Established ROW sales, grew by 27% (CER: 26%) to $2,548 million. Sales of New Medicines in Japan were $1,149 million, driven by largely by sales of Tagrisso, which increased by 100% (CER: 97%) to $633 million. However, sales were adversely impacted in the final quarter of 2019 by a 15% mandated price reduction that took effect from 1 November 2019.
Sales by Region in 2021
Emerging Markets
Sales in Emerging Markets increased by 40% (CER: 36%) to $12,161 million (2020: $8,679 million; 2019: $8,165 million).
Oncology
Oncology sales in Emerging Markets increased by 11% (CER: 6%) to $3,223 million (2020: $2,906 million; 2019: $2,211 million).
Tagrisso sales in Emerging Markets increased by 11% (CER: 6%) to $1,336 million (2020: $1,208 million; 2019: $762 million). Sales performance was impacted by the admission to China NRDL in March 2021 for the 1st-line setting and the renewal in the 2nd-line setting. However, the rising demand from increased patient access in China almost completely offset the NRDL price reduction during the year.
Imfinzi sales in Emerging Markets increased by 76% (CER: 68%) to $277 million (2020: $158 million; 2019: $30 million) as a result of recent launches.
Lynparza sales in Emerging Markets increased by 45% (CER: 41%) to $384 million (2020: $264 million; 2019: $133 million), benefiting from increased patient access to Lynparza following admission to the NRDL as a 1st-line treatment for BRCAm ovarian cancer patients with effect from March 2021.
Calquence sales in Emerging Markets were $20 million (2020: $6 million; 2019: $2 million).
Orpathys after its launch in 2021, contributed to a sales of $16 million (2020: $nil; 2019: $nil) in Emerging Markets.
Zoladex sales in Emerging Markets increased by 10% (CER: 5%) to $619 million (2020: $561 million; 2019: $492 million) driven by ex-China markets.
Faslodex sales in Emerging Markets fell by 8% (CER: 10%) to $167 million (2020: $180 million; 2019: $198 million) due to increasing competition from several generic versions of the medicine.
Iressa sales in Emerging Markets declined by 31% (CER: 35%) to $151 million (2020: $221 million; 2019: $286 million) reflecting generic competition and increasing patient access to Tagrisso for 1st-line treatment in China, as a result of NRDL changes.
28
Casodex sales in Emerging Markets declined by 21% (CER: 26%) to $105 million (2020: $133 million; 2019: $127 million).
Arimidex sales in Emerging Markets declined by 28% (CER: 31%) to $106 million (2020: $147 million; 2019: $152 million).
CVRM
CVRM sales in Emerging Markets increased by 18% (CER: 14%) to $3,780 million (2020: $3,203 million; 2019: $2,978 million).
Forxiga sales in Emerging Markets increased by 74% (CER: 70%) to $1,195 million (2020: $686 million; 2019: $471 million, benefitting from the addition of Forxiga to the China NRDL in 2020. The initial price impact was more than offset by increased access for patients. The NRDL status of Forxiga was renewed in the fourth quarter of 2021.
Emerging Markets sales of Brilinta declined by 29% (CER: 31%) to $328 million (2020: $461 million; 2019: $462 million), reflecting the implementation of China’s VBP programme in November 2020, resulting in significantly lower market access for the medicine, and a mandatory price cut.
Bydureon sales in Emerging Markets declined by 25% (CER: 26%) to $3 million (2020: $4 million; 2019: $11 million).
Onglyza sales in Emerging Markets decreased by 11% (CER: 14%) to $179 million (2020: $201 million; 2019: $176 million).
Byetta sales in Emerging Markets grew by 61% (CER: 75%) to $12 million (2020: $8 million; 2019: $12 million).
Roxadustat sales in Emerging Markets amounted to $174 million (2020: $nil; 2019: $nil). From January 2021, AstraZeneca started recognising the overwhelming majority of China revenue as Product Sales following an amendment in July 2020 to the existing licence agreement with FibroGen.
Crestor sales in Emerging Markets increased by 4% (stable at CER) to $775 million (2020: $748 million; 2019: $806 million) despite the adverse impact of China’s VBP programme.
Seloken sales in Emerging Markets grew by 19% (CER: 13%) to $928 million (2020: $782 million; 2019: $686 million).
Atacand sales in Emerging Markets fell by 84% to $28 million (2020: $175 million; 2019: $160 million).
Respiratory & Immunology
Respiratory & Immunology sales in Emerging Markets increased by 9% (CER: 4%) to $1,749 million (2020: $1,599 million; $1,987 million).
Emerging Markets sales of Symbicort increased by 7% in the year (4% at CER) to $609 million (2020: $567 million; 2019: $547 million) driven by growth in markets outside China.
Fasenra sales in Emerging Markets grew by 67% to $20 million (2020: $12 million; 2019: $5 million).
Pulmicort sales in Emerging Markets, which represents 80% of the global total, declined by 3% (CER: 9%) to $770 million (2020: $798 million; 2019: $1,190 million) largely as a result of the inclusion of Pulmicort in the latest round of VBP in China implemented in 2021. This resulted in significantly lower market access for the medicine and a mandatory price reduction in China. This impact was partially offset by growth in Emerging Markets ex-China.
Daliresp sales in Emerging Markets were stable at $4 million (decline by 2% at CER) (2020: $4 million; 2019: $4 million)
Breztri sales in Emerging Markets were $55 million (2020: $14 million; 2019: $nil). In China, Breztri is the market share leader within the fixed-dose triple market, which continues to gain share from ICS/LABA class.
Bevespi sales in Emerging Markets increased to $4 million during the year (2020: $1 million; 2019: $nil).
Rare Disease
Rare Disease sales in Emerging Markets were $196 million, representing a pro rata growth of 11%1 (CER: 18%).
29
Soliris sales in the Emerging Markets amounted to $170 million, representing a pro rata increase of 1%1 (8% at CER).
Ultomiris sales in the Emerging Markets amounted to $9 million.
Strensiq sales in the Emerging Markets grew to $10 million, representing a pro rata increase of 81%1 (CER: 78%).
Other
Other medicines sales in Emerging Markets decreased by 2% (CER: 5%) to $954 million (2020: $971 million; 2019: $989 million).
Nexium sales in Emerging Markets decreased by 7% (CER: 10%) to $705 million (2020: $757 million; 2019: $748 million), reflecting the impact of the inclusion of Nexium (oral) in China’s VBP programme in 2021 resulting in significantly lower market access and a mandatory price reduction.
Synagis sales in Emerging Markets were stable at $35 million (2020: $nil; 2019: $nil).
Losec/ Prilosec sales in Emerging Markets were stable (CER: decreased by 7%) at $152 million (2020: $152 million; 2019: $179 million).
Seroquel IR/XR sales in Emerging Markets fell by 17% (CER: 15%) to $46 million (2020: $55 million; 2019: $50 million).
COVID-19
Vaxzevria sales in Emerging Markets were $2,240 million (2020: $nil; 2019: $nil) and contributed 57% to total sales of Vaxzevria.
Evusheld sales in Emerging Markets were $19 million (2020: $nil; 2019: $nil).
U.S.
Sales in the U.S. increased by 39% to $12,000 million (2020: $8,638 million; 2019: $7,747 million).
Oncology
Oncology sales in the U.S. increased by 26% to $5,359 million (2020: $4,250 million; 2019: $3,449 million).
Tagrisso sales in the U.S. increased by 14% to $1,780 million (2020: $1,566 million; 2019: $1,268 million). Performance benefitted from greater 1st-line and adjuvant use, partially offset by lower 2nd-line use and a continued negative impact on diagnosis, testing and treatment from the pandemic. The rates of diagnosis and testing in lung and other cancers declined during 2021, as a result of the latest wave of COVID-19 cases, and remained below pre-pandemic levels at the end of the year.
Imfinzi sales in the U.S. increased by 5% to $1,245 million (2020: $1,185 million; 2019: $1,041 million) despite the continued COVID-19-related decrease in lung cancer diagnoses.
Lynparza sales in the U.S. grew by 24% to $1,087 million (2020: $876 million; 2019: $626 million), as a result of increased growth in use in ovarian, breast and prostate cancers where Lynparza remains the leading medicine in the PARP inhibitor class globally across four tumour types, as measured by total prescription volumes.
Calquence sales in the U.S. exhibited a strong performance with an increase to $1,089 million (2020: $511 million; 2019: $162 million) despite COVID-19 impacts on CLL diagnosis rates, benefitting from increased new patient market share.
Koselugo sales in the U.S. increased to $104 million (2020: $38 million; 2019: $nil) following its launch in 2020.
Faslodex sales in the U.S. declined by 46% to $30 million (2020: $55 million; 2019: $328 million) due to increasing competition from several generic versions of the medicine.
Iressa sales in the U.S. decreased by 23% to $11 million (2020: $14 million; 2019: $17 million).
CVRM
CVRM sales in the U.S. increased by 2% to $2,124 million (2020: $2,083 million; 2019: $2,209 million).
30
In the U.S. Farxiga sales grew by 29% to $732 million (2020: $569 million; 2019: $537 million), reflecting the benefit of the regulatory approval in 2020 for HFrEF and the May 2021 approval for the treatment of CKD, both of which include patients with and without T2D.
Brilinta sales in the U.S. increased by 1% to $735 million (2020: $732 million; 2019: $710 million), partly reflecting the recent launch of Brilinta as a treatment to reduce the risk of stroke in patients following an acute ischaemic stroke or high-risk transient ischaemic attack.
Bydureon sales in the U.S. declined by 16% to $321 million (2020: $382 million; 2019: $459 million) following the withdrawal of the dual-chamber pen and lower demand for the Bydureon BCise auto-injector device.
U.S sales of Onglyza fell by 47% in the year to $88 million (2020: $166 million; 2019: $230 million) as the DPP-4 inhibitor class continues to decline.
Byetta sales in the U.S. declined by 31% to $26 million (2020: $37 million; 2019: $68 million).
Lokelma sales in the U.S. where it continued to be the branded market share leader, increased to $115 million (2020: $57 million; 2019: $13 million), reflecting the growth in the potassium binder class.
Crestor sales in the U.S. decreased by 13% to $80 million (2020: $92 million; 2019: $104 million).
Seloken sales in the U.S. declined by 89% to $1 million (2020: $13 million; 2019: $37 million).
Respiratory & Immunology
Respiratory & Immunology sales in the U.S. increased by 24% to $2,404 million (2020: $1,941 million; 2019: $1,653 million).
Symbicort sales in the U.S. increased by 4% to $1,065 million (2020: $1,022 million; 2019: $829 million). Symbicort maintained total prescription market share in a declining ICS/LABA market as fixed-dose triple therapies (LAMA/LABA/ICS) launches continue.
Fasenra sales in the U.S. increased by 31% to $790 million (2020: $603 million; 2019: $482 million), benefiting from growth in new patient starts.
Pulmicort sales in the U.S. increased by 1% to $72 million (2020: $71 million; 2019: $110 million).
Daliresp/Daxas sales in the U.S. increased by 9% to $207 million (2020: $190 million; 2019: $184 million).
Breztri sales in the U.S. were $115 million (2020: $5 million; 2019: $nil), following market share growth in the fixed-dose triple market.
Bevespi sales in the U.S. decreased by 11% to $39 million (2020: $44 million; 2019: $42 million).
Saphnelo sales in the U.S. amounted to $8 million (2020: $nil; 2019: $nil) following its launch in at the end of third quarter of the year.
Rare Disease
Rare Disease sales in the U.S. were $1,828 million, representing a pro rata decline of 8%.
Soliris sales in the U.S. increased by 4% representing a pro rata increase to $1,068 million. Sales benefitted from growing use in neurology indications, gMG and NMOSD, offset by the successful conversion to Ultomiris in haematological indications PNH and aHUS.
Ultomiris sales in the U.S. increased by 20% on a pro rata basis to $381 million, as a result of the successful conversion from Soliris in PNH and aHUS, where Ultomiris offers patients a lower average annual treatment cost, and a more convenient dosing schedule with every eight week dosing versus the every two week regimen for Soliris.
Strensiq sales in the U.S. increased to $297 million, representing a pro rata growth of 13%. Performance benefitted from increased demand over the course of the year as well as supply-chain inventory movements.
Andexxa sales in the U.S. were $50 million, representing a pro rata decline of 21%.
31
Kanuma sales in the U.S. increased by 13% on a pro rata basis to $32 million.
Other
Other medicines sales in the U.S. decreased by 39% to $221 million (2020: $364 million; 2019: $436 million).
Nexium sales in the U.S. decreased by 24% to $128 million (2020: $169 million; 2019: $218 million).
Synagis sales in the U.S. decreased by 51% to $23 million (2020: $47 million; 2019: $46 million).
FluMist sales in the U.S. declined by 62% to $27 million in the year (2020: $70 million; 2019: $20 million), due to a one-off supplemental order in the U.S. in 2020 causing an unfavourable comparison to the prior year.
Seroquel sales in the U.S. decreased by 30% to $12 million (2020: $17 million; 2019: $34 million).
COVID-19
Vaxzevria sales in the U.S. were $64 million (2020: $nil; 2019: $nil).
Europe
Product Sales in Europe increased by 50% (CER: 44%) and grew to $7,604 million (2020: $5,059 million; 2019: $4,350 million).
Oncology
Oncology sales in Europe increased by 28% (CER: 22%) to $2,484 million (2020: $1,938 million; 2019: $1,423 million).
Tagrisso sales in Europe increased by 32% (CER: 25%) to $986 million (2020: $748 million; 2019: $474 million), driven by greater adoption in the 1st-line and adjuvant settings, as more reimbursements were granted.
Imfinzi sales in Europe increased by 31% (CER: 25%) to $485 million (2020: $370 million; 2019: $179 million), reflecting an increase in ES-SCLC market penetration and an increase in the number of reimbursed markets.
Lynparza sales in Europe increased by 42% (CER: 35%) to $618 million (2020: $435 million; 2019: $287 million), reflecting additional reimbursements and increasing BRCAm-testing rates, as well as successful 1st-line BRCAm ovarian, 2nd-line HRRm prostate and germline BRCAm HER2-negative advanced breast cancer launches.
Calquence sales in Europe were $111 million (2020: $2 million; 2019: $nil) through increased market share in new patient starts after launches in the region.
Koselugo sales in Europe were $3 million (2020: $nil; 2019: $nil).
Enhertu sales in Europe were $4 million (2020: $nil; 2019: $nil).
Zoladex sales in Europe increased by 5% (CER: declined by 1%) to $147 million (2020: $140 million; 2019: $135 million).
Faslodex sales in Europe decreased by 49% (CER: 52%) to $113 million (2020: $221 million; 2019: $229 million) due to increasing competition from several generic versions of the medicine.
Iressa sales in Europe declined by 58% (CER: 60%) to $5 million (2020: $12 million; 2019: $70 million).
CVRM
CVRM sales in Europe increased by 22% (CER: 16%) to $1,494 million (2020: $1,228 million; 2019: $1,151 million).
Forxiga sales in Europe increased by 60% (CER: 52%) to $810 million (2020: $507 million; 2019: $373 million). The performance reflected SGLT2 inhibitor class growth, the beneficial addition of CV outcomes trial data to the label, the HFrEF regulatory approval in 2020, and CKD regulatory approval in 2021.
32
Brilique sales in Europe increased by 1% (CER: declined by 4%) to $346 million (2020: $342 million; 2019: $351 million). The overall performance in the year was adversely impacted by fewer elective procedures due to the effects of the pandemic.
Bydureon sales in Europe increased by 5% (stable at CER) to $55 million (2020: $53 million; 2019: $66 million). Onglyza sales in Europe increased by 5% (CER: declined by 1%) to $61 million (2020: $58 million; 2019: $70 million).
Lokelma sales in Europe amounted to $13 million (2020: $4 million; 2019: $1 million) during the year with expansion in Europe continued with launches in several new markets.
Crestor sales in Europe declined by 60% (CER: 62%) to $52 million (2020: $129 million; 2019: $148 million), following the divestment of European rights in more than 30 countries to Grünenthal in February 2021.
Respiratory & Immunology
Respiratory & Immunology sales in Europe grew by 6% (CER: 1%) to $1,247 million (2020: $1,171 million; 2019: $1,107 million).
Symbicort sales in Europe decreased by 3% (CER: 8%) to $670 million (2020: $694 million; 2019: $678 million), as a result of year-on-year decline due to the favourable COVID-19 impact on FY 2020.
Fasenra sales in Europe increased by 41% (CER: 34%) to $286 million (2020: $203 million; 2019: $118 million), benefiting from growth in new patient starts, despite the COVID-19 impact on total severe asthma market growth.
Pulmicort sales in Europe were stable (CER: decline of 5%) at $73 million (2020: $73 million; 2019: $81 million).
Daliresp/Daxas sales in Europe decreased by 32% (CER: 37%) to $15 million (2020: $22 million; 2019: $26 million).
Bevespi sales in Europe were $11 million (2020: $3 million; 2019: $nil).
Rare Disease
Rare Disease sales in Europe grew to $682 million, representing a pro rata increase of 7% (CER: 9%).
Soliris sales in the Europe decreased to $439 million, representing a pro rata decline of 8% (CER: 7%).
Ultomiris sales in the Europe increased to $169 million, representing a pro rata increase of 73% (CER: 74%), driven by new country launches in the year.
Strensiq sales in the Europe increased to $36 million, representing a pro rata increase of 2% (CER: 3%).
Andexxa sales in the Europe were $18 million, representing a pro rata increase of 7% (CER: 6%).
Kanuma sales in the Europe were $20 million, representing a pro rata increase of 7% (CER: 9%)
Other
Other medicines sales in Europe decreased by 17% (CER: 19%) to $596 million (2020: $722 million; 2019: $669 million).
Nexium sales in Europe decreased by 13% (CER: 18%) to $62 million (2020: $71 million; 2019: $63 million.
Synagis sales in Europe decreased by 38% (CER: 37%) to $203 million (2020: $325 million; 2019: $312 million). This was due to the expiry of the ex-US commercial rights agreement between AstraZeneca and AbbVie in 2021, and changes as a result of the reversion of ex-US rights to AstraZeneca thereafter, prior to which AstraZeneca’s sales to AbbVie were reported in Europe.
FluMist sales in Europe grew by 1% (CER: declined by 2%) to $222 million (2020: $219 million; 2019: $93 million).
Losec/Prilosec sales in Europe increased by 32% (CER: 31%) to $26 million (2020: $20 million; 2019: $49 million).
Seroquel XR/IR sales in Europe increased by 2% to $29 million (2020: $29 million; 2019: $88 million).
33
COVID-19
Vaxzevria sales in Europe were $1,035 million (2020: $nil; 2019: $nil).
Evusheld sales in Europe were $66 million (2020: $nil; 2019: $nil).
Established ROW
Product Sales in the Established ROW region increased by 36% (CER: 36%) to $4,776 million (2020: $3,514 million; 2019: $3,303 million).
Oncology
Oncology sales in the Established ROW region increased by 13% to $1,982 million (2020: $1,756 million; 2019: $1,584 million). Sales in Japan increased by 10% (CER: 12%) to $1,665 million in the year.
Tagrisso sales in the Established ROW region increased by 13% (CER: 14%) to $913 million (2020: $806 million; 2019: $685 million). In Japan, sales of Tagrisso grew by 6% (CER: 8%) to $775 million in the year.
Imfinzi sales in the Established ROW region grew by 23% to $405 million (2020: $329 million; 2019: $219 million). In Japan, sales of $345 million represented growth of 28% (30% at CER), where market share in ES-SCLC increased.
Lynparza sales in the Established ROW region increased by 29% (CER: 28%) to $259 million (2020: $201 million; 2019: $152 million). Sales in Japan amounted to $199 million, representing growth of 19% (CER: 21%).
Calquence sales in the Established ROW region were $18 million (2020: $3 million; 2019: $nil).
Zoladex sales in the Established ROW region decreased by 7% to $169 million (2020: $182 million; 2019: $179 million). In Japan, sales increased by 7% (CER: 9%) to $139 million.
Faslodex sales in the Established ROW region decreased by 2% (CER: 1%) to $121 million (2020: $124 million; 2019: $137 million). In Japan, sales increased by 1% (CER: 3%) to $118 million.
Iressa sales in the Established ROW region declined by 26% to $16 million (2020: $21 million; 2019: $50 million).
CVRM
CVRM sales in the Established ROW region increased by 7% (CER: 5%) to $622 million (2020: $582 million; 2019: $568 million).
Forxiga sales in the Established ROW region increased by 34% (CER: 31%) to $263 million (2020: $197 million; 2019: $162 million). Japan sales grew by 35% (CER: 38) to $150 million.
Brilinta sales in the Established ROW region increased by 8% (CER: declined by 1%) to $63 million (2020: $58 million; 2019: $58 million).
Bydureon sales in the Established ROW region declined by 40% (CER by 44%) to $6 million (2020: $9 million; 2019: $13 million).
Onglyza sales in the Established ROW region declined by 29% (CER: 33%) to $32 million (2020: $45 million; 2019: $51 million).
Byetta sales in the Established ROW region declined by 36% (CER: 38%) to $6 million (2020: $9 million; 2019: $11 million).
Lokelma sales in the Established ROW region were $44 million (2020: $10 million; 2019: $nil). Sales in Japan increased to $43 million in the year (2020: $10 million; 2019: $nil) despite Ryotanki, a regulation that restricts prescriptions to two weeks’ supply in the first year of launch. The restriction was eventually lifted in June 2021 and no longer applies.
Crestor sales in the Established ROW region decreased by 11% (CER: 10%) to $189 million (2020: $211 million; 2019: $220 million) with a decline in Japan sales by 8% (7% at CER) to $151 million (2020: $164 million; 2019: $171 million), where AstraZeneca collaborates with Shionogi.
34
Seloken/Toprol-XL sales in the Established ROW region showed an increase by 9% (3% decline at CER) to $11 million (2020: $10 million; 2019: $12 million).
Atacand sales in the Established ROW region fell to $nil in 2021 (2020: $23 million; 2019: $19 million).
Respiratory & Immunology
Respiratory & Immunology sales in the Established ROW region decreased by 2% (CER: 5%) to $634 million (2020: $646 million; 2019: $644 million).
Symbicort sales in the Established ROW region decreased by 12% (CER: 17%) to $384 million (2020: $438 million; 2019: $441 million). Sales in Japan declined by 34% (33% at CER) to $124 million (2020: $189 million; 2019: $226 million) in the year due to continued generic competition.
Fasenra sales in the Established ROW region increased by 24% (CER: 22%) to $162 million (2020: $131 million; 2019: $99 million).
Pulmicort sales in the Established ROW region declined by 13% (CER: 15%) to $47 million (2020: $54 million; 2019: $85 million). In Japan, sales decreased by 24% (22% at CER) in the year to $23 million (2020: $30 million; 2019: $62 million) following increasing generic competition.
Breztri sales in the Established ROW region were $26 million (2020: $9 million; 2019: $2 million) which is largely contributed by the sales in Japan for $25 million (2020: $9 million; 2019: $2 million).
Rare Disease
Rare Disease sales in Established ROW increased on a pro rata basis by 7% (CER: 11%) to $364 million.
Soliris sales in the Established ROW increased on a pro rata basis by 8% (CER: 11%) to $197 million.
Ultomiris sales in the Established ROW increased on a pro rata basis by 4% (CER: 11%) to $129 million, driven by new country launches in the year.
Strensiq sales in the Established ROW increased on a pro rata basis by 9% (CER: 14%) to $35 million.
Kanuma sales in the Established ROW increased on a pro rata basis by 14% (CER: 25%) to $3 million.
Other
Other sales in the Established ROW region increased by 12% (CER: 15%) to $596 million (2020: $530 million; 2019: $507 million).
Nexium sales in the Established ROW region decreased by 13% (CER: 12%) to $431 million (2020: $495 million; 2019: $454 million). Sales in Japan declined by 13% (11% at CER) to $369 million, where AstraZeneca collaborated with Daiichi Sankyo until September 2021.
COVID-19
Vaxzevria sales in the Established ROW region were $578 million (2020: $nil; 2019: $nil).
Disclosures Under the Iran Threat Reduction and Syria Human Rights Act of 2012
AstraZeneca is a global, innovation-driven biopharmaceutical business with operations in over 100 countries and its innovative medicines are used by millions of patients worldwide. AstraZeneca has a legal entity based in Iran, AstraZeneca Pars Company (“AstraZeneca Pars”), which has no employees, and is owned by non-U.S. Group companies. In July 2017, AstraZeneca Pars submitted regulatory applications to the Iranian Food and Drug Administration and subsequently received marketing authorizations for several products. AstraZeneca Pars has not entered into any commercial transaction since its incorporation; products registered under AstraZeneca Pars are exclusively sold by a third-party distributor.
AstraZeneca, through one of its non-U.S. Group companies that is neither a U.S. person nor a foreign subsidiary of a U.S. person, currently has sales of prescription pharmaceuticals in Iran solely through a single third-party distributor, which uses three known entities in the Iranian distribution chain. At this time, none of AstraZeneca’s U.S. entities are involved in any business activities in Iran, or with the Iranian government. To the best knowledge of the management of AstraZeneca, the third-party distributor used by AstraZeneca is not owned or controlled by the Iranian government and AstraZeneca does not
35
have any agreements, commercial arrangements, or other contracts with the Iranian government. However, AstraZeneca understands that one of the independent sub-distributors of AstraZeneca’s third-party distributor is likely to be indirectly controlled by the Iranian government. Further, AstraZeneca’s third-party distributor may initiate payments using banks associated with the government of Iran for the purchase of AstraZeneca products. Finally, Government agencies, hospitals and institutions may purchase AstraZeneca products from the third party distributor or the sub-distributors.
AstraZeneca supplied its COVID-19 vaccine to COVAX and various governments. The vaccine was supplied to Iran as part of the COVAX supply or through government donations. AstraZeneca verified that the supply of the vaccine to Iran by COVAX or through donations is permitted under the OFAC regulations/licenses.
On February 11, 2017, a non-U.S. Group company that is neither a U.S. person nor a foreign subsidiary of a U.S. person entered into a memorandum of understanding with the Iranian Ministry of Health, whereby AstraZeneca committed to improving the overall quality of healthcare and ensuring that Iranian patients have access to the latest innovative and cost-effective medicines. The memorandum of understanding is still in effect. Throughout 2017 to 2020, AstraZeneca, through a distributor, conducted health care provider education programs in Iran, including for employees of hospitals owned or controlled by the Iranian Ministry of Health. In this context, AstraZeneca may make additional products available in Iran in the future; where required, relevant U.S. licenses will be sought.
For the year ended December 31, 2021, the Company’s gross revenues and net profits attributable to the above-mentioned Iranian activities were $18.8 million and $7.8 million respectively. For the same period, AstraZeneca’s gross revenues and net profits were $37.4 billion and $0.1 billion, respectively. Accordingly, the gross revenues and net profits attributable to the above-mentioned Iranian activities amounted to approximately 0.05% of AstraZeneca’s gross revenues and approximately 6.8% of its net profits.
At the time of publication, the management of AstraZeneca does not anticipate any change in its activities in Iran that would result in a material impact on AstraZeneca
C. Organizational Structure
The information (including tabular data) set forth under the headings “Additional Information—Directors’ Report—Subsidiaries and principal activities” on page 213, “—Branches and countries in which the Group conducts business” on page 213, and “Financial Statements—Group Subsidiaries and Holdings” on pages 197 to 201, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
D. Property, Plant and Equipment
Please see the information below under the heading Item 5—“Operating and Financial Review and Prospects—Operating Results—2021 compared with 2020”. The information (including tabular data) set forth under the headings “Strategic Report—Business Review—Accelerate Innovative Science—Research & Development” on pages 32 to 34, “Strategic Report—Business Review—Operations” on pages 37 to 39, “Strategic Report—Financial Review—Financial position—31 December 2021—Property, plant and equipment” on page 63, “Financial Statements—Notes to the Group Financial Statements—Note 7—Property, plant and equipment” on page 154, “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments and contingent liabilities—Environmental costs and liabilities” on pages 189 to 190 and “Financial Statements—Notes to the Group Financial Statements—Note 8—Leases” on page 155, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
Substantially all of the Group’s properties are held freehold, free of material encumbrances and are fit for their purpose. For more information, please refer to “Financial Statements—Notes to the Group Financial Statements—Note 7—Property, plant and equipment” on page 154 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022.
ITEM 4A. UNRESOLVED STAFF COMMENTS
Not applicable.
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS
The information (including graphs and tabular data) set forth under the headings “Strategic Report—Our Strategy and Key Performance Indicators” on pages 12 to 15, “Strategic Report—Business Review—Accelerate Innovative Science—Research & Development” on pages 32 to 34, “Financial Statements— Notes to the Group Financial Statements—Note 1—Revenue—Product Sales” on page 145, “Financial Statements—Notes to the Group Financial Statements—Note 19—Interest-bearing loans and borrowings” on pages 164 to 165, “Financial Statements—Notes to the Group Financial Statements—Note 13—
36
Derivative financial instruments” on page 161, “Financial Statements—Notes to the Group Financial Statements—Note 23—Reserves” on page 175, “Financial Statements—Notes to the Group Financial Statements—Note 28—Financial risk management objectives and policies” on pages 180 to 186, “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments and contingent liabilities” on pages 189 to 196 and “Additional Information—Important information for readers of this Annual Report” on page 228, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference. Please also see the information above under the heading Item 4—“Information on the Company— Business Overview—Geographical Review”.
We consider the Group’s working capital to be sufficient for its present requirements.
A.Operating Results
2021 compared with 2020
The information set forth under the heading “Strategic Report—Financial Review” on pages 52 to 70 (excluding the information set forth under the subheading “Full year 2022: additional commentary” on page 66) of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated herein by reference.
2020 compared with 2019
Please see the information set forth under the heading “Strategic Report—Financial Review” on pages 82 to 100 of AstraZeneca’s “Annual Report and Form 20-F Information 2020” included as exhibit 15.1 to the Form 20-F dated February 16,2021.
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A. Directors and Senior Management
The information (including tabular data) set forth under the headings “Corporate Governance—Corporate Governance Overview— Board of Directors as at 31 December 2021” on pages 74 to 75, and “Corporate Governance—Annual Report on Remuneration—Governance—Directors’ service contracts and letters of appointment” on page 124, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference. On February 22, 2022, we announced that Leif Johansson, Non-Executive Chair of the Board, intends to retire from the Board at the conclusion of the Company's Annual General Meeting in 2023. The search for a new Chair is being led by Philip Broadley, senior independent Non-Executive Director.
In addition to the Board of Directors, the Senior Executive Team, or SET, is the body through which the CEO exercises the authority delegated to him by the Board. The CEO leads the SET and has executive responsibility for the management, development and performance of the business. The CEO, CFO and SET also take the lead in developing the strategy for review, constructive challenge and approval by the Board as part of the annual strategy review process. The information set forth under the heading “Corporate Governance—Senior Executive Team (SET) as at 31 December 2021” on page 76 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
Senior Executive Team (SET) Biographies as at December 31, 2021
Susan Galbraith - Executive Vice-President, Oncology R&D
Susan is responsible for our Oncology portfolio from discovery through to late-stage development. She joined AstraZeneca from Bristol-Myers Squibb in 2010, since when she has been responsible for transforming the productivity and scientific output from Early Oncology. Susan studied Medicine at Manchester and Cambridge Universities and has a PhD from the University of London. She was admitted to Membership of the Royal College of Physicians in 1992, and then trained in clinical oncology in London. Susan gained Fellowship of the Royal College of Radiologists in 1997, was awarded an honorary Doctorate of Medical Science from the Institute of Cancer Research in 2017, and was admitted to Fellowship of the Academy of Medical Sciences in 2018. Susan is on the Scientific Advisory Board of the Institute of Cancer Research. In 2021 she was elected to the Board of Directors of the American Association for Cancer Research, and serves on the European Association of Cancer Research Advisory Council.
Iskra Reic – Executive Vice-President, Vaccines & Immune Therapies
Iskra was appointed Executive Vice-President (EVP), Vaccines & Immune Therapies, in November 2021, and is responsible for both the early and late stage development of the Unit’s pipeline and portfolio, as well as medical affairs and commercial operations. Iskra trained as a Doctor of dental medicine at the Medical University of Zagreb, Croatia. She joined
37
AstraZeneca in 2001 and during this time has held a variety of in-market, regional sales and marketing and general management roles, including Head of Specialty Care, Central & Eastern Europe, Middle East and Africa. In 2012 she joined AstraZeneca Russia as Marketing Director, before being appointed General Manager in 2014. Subsequently in 2016 Iskra was made Area Vice-President for Russia and Eurasia, before her appointment as EVP, Europe in April 2017, and the later expansion of this role to Europe & Canada in 2019. Iskra has an International Executive MBA in Business and Leadership from the IEDC-Bled School of Management, Slovenia.
Menelas Pangalos – Executive Vice-President, BioPharmaceuticals R&D
Mene is responsible for BioPharmaceuticals R&D from discovery through to late-stage development across CVRM, Respiratory & Immunology, Vaccines & Immune Therapies and Neuroscience. Since joining AstraZeneca in 2010, Mene has led the transformation of R&D leading to a greater than five fold improvement in productivity. Mene holds Honorary Doctorates from Glasgow University and Imperial College, London, is a Fellow of the Academy of Medical Sciences, the Royal Society of Biology and Clare Hall, University of Cambridge and is a Visiting Professor at The Wolfson Centre at Kings College. He co-chairs the UK Life Sciences Council Expert Group on Innovation, Clinical Research and Data and is a member of the Life Sciences Industrial Strategy Implementation Board. He is also on the Boards of The Francis Crick Institute, The Judge Business School, Cambridge University and Dizal Pharma, and is a member of the Life Sciences Vision Advisory Group. In 2019, Mene was awarded a knighthood from The Queen and the Prix Galien Medal, Greece. In 2021 Mene was awarded an Honorary Fellowship of the British Pharmacological Society. He has overseen the creation of AstraZeneca’s new Global R&D Centre in Cambridge and the Company’s COVID-19 efforts.
Ruud Dobber – Executive Vice-President, BioPharmaceuticals Business Unit
Ruud has responsibility for product strategy and commercial delivery for CVRM, Respiratory & Immunology, and Vaccines & Immune Therapies. Ruud joined Astra in 1997 and has held assumed leadership roles with increasing responsibility including Executive Vice-President, North America; Executive Vice-President, Europe; Regional Vice-President, Europe, Middle East and Africa; and Regional Vice-President, Asia Pacific. Ruud served as a member of the board and executive committee of the European Federation of Pharmaceutical Industries and Associations and was previously Chairman of the Asia division of Pharmaceutical Research and Manufacturers of America. In June 2021, Ruud was appointed as a Non-Executive Director of the Board of Almirall S.A.. Ruud holds a doctorate in immunology from the University of Leiden, Netherlands, beginning his career as a research scientist in immunology and ageing.
Pam Cheng – Executive Vice-President, Operations & Information Technology
Pam joined AstraZeneca in June 2015, after 18 years with Merck/MSD in Global Manufacturing, Supply Chain and Commercial roles. She was the Head of Global Supply Chain Management & Logistics for Merck and led the transformation of Merck supply chains across the global supply network. Pam also held the role of President of MSD China. Prior to joining Merck, Pam held various engineering and project management positions at Universal Oil Products, Union Carbide Corporation and GAF Chemicals. She holds Bachelor’s and Master’s degrees in chemical engineering from Stevens Institute of Technology, New Jersey and an MBA from Pace University in New York. Pam serves as a Non-Executive Director of the Smiths Group plc board.
David Fredrickson – Executive Vice-President, Oncology Business Unit
Dave is responsible for driving growth and maximising the commercial performance of the AstraZeneca global Oncology portfolio. He has global accountability for marketing, sales, medical affairs and market access in Oncology and plays a critical leadership role in setting the Oncology portfolio and product strategy. Previously, Dave served as President of AstraZeneca K.K. in Japan, and Vice-President, Specialty Care in the US. Before joining AstraZeneca, Dave worked at Roche/Genentech, where he served in several functions and leadership positions, including Oncology Business Unit Manager in Spain, and strategy, marketing and sales roles in the US. Dave is a graduate of Georgetown University in Washington DC.
Marc Dunoyer – Chief Executive Officer Alexion
Marc became CEO of Alexion, AstraZeneca’s Rare Disease group, in August 2021 following its acquisition in July. He had previously served as an Executive Director and AstraZeneca’s Chief Financial Officer from November 2013. Marc’s career in pharmaceuticals, which has included periods with Roussel Uclaf, Hoechst Marion Roussel and GSK, has given him extensive industry experience. He is a qualified accountant and joined AstraZeneca in 2013, serving as Executive Vice-President, Global Product and Portfolio Strategy from June to October 2013. Prior to that, he served as Global Head of Rare Diseases at GSK and (concurrently) Chairman, GSK Japan. He holds an MBA from HEC Paris and a Bachelor of Law degree from Paris University.
38
Other appointments: Marc is a Director of Orchard Therapeutics Plc.
Leon Wang – Executive Vice-President, International and China President
Leon Wang is responsible for overall strategy driving sustainable growth across the International region, which includes China. Leon joined AstraZeneca China in March 2013 and was promoted to become President, AstraZeneca China in 2014. Under Leon’s leadership, China has become AstraZeneca’s second-largest market worldwide and AstraZeneca has become the largest pharmaceutical company in China. Prior to joining AstraZeneca, Leon held positions of increasing responsibility in marketing and business leadership at Roche, where he was a Business Unit Vice-President. In addition, Leon holds several positions in local trade associations and other prominent organisations in China. Leon holds an EMBA from China Europe International Business School, and a Bachelor of Arts from Shanghai International Studies University.
Katarina Ageborg – Executive Vice-President, Sustainability and Chief Compliance Officer
Katarina has overall responsibility for the delivery, design and implementation of the Company’s sustainability programme, covering three priority areas: access to healthcare; environmental protection; and ethics and transparency. She leads the Global Sustainability function, focusing on Compliance, and Safety, Health and Environment. Katarina was appointed President of AstraZeneca AB (Sweden) in 2018. Prior to these roles, Katarina led the Global Intellectual Property function from 2008-2011, before taking the role as Chief Compliance Officer. Katarina holds a Master of Law Degree from Uppsala University School of Law in Sweden and ran her own law firm before joining AstraZeneca in 1998.
Jeff Pott – General Counsel and Chief Human Resources Officer
Jeff was appointed General Counsel in January 2009 and has overall responsibility for all aspects of AstraZeneca’s Legal and IP function. In addition to his role as General Counsel, he was appointed Chief Human Resources Officer in January 2021 assuming additional responsibilities for the AstraZeneca Human Resources function. Jeff joined AstraZeneca in 1995 and has worked in various litigation roles, where he has had responsibility for IP, anti-trust and product liability litigation. Before joining AstraZeneca, he spent five years at the US legal firm Drinker Biddle and Reath LLP, where he specialised in pharmaceutical product liability litigation and anti-trust advice and litigation. He received his Bachelor’s degree in political science from Wheaton College and his Juris Doctor Degree from Villanova University School of Law.
B. Compensation
The information (including graphs and tabular data) set forth under the headings “Corporate Governance—Directors’ Remuneration Report” on pages 98 to 104, “Corporate Governance—Annual Report on Remuneration” on pages 105 to 124, “Financial Statements—Notes to the Group Financial Statements—Note 22—Post-retirement and other defined benefits” on pages 168 to 175, “Financial Statements—Notes to the Group Financial Statements—Note 29—Employee costs and share plans for employees” on pages 186 to 189 and “Financial Statements—Notes to the Group Financial Statements—Note 31—Statutory and other information—Key management personnel compensation”, on page 196, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
C. Board Practices
The information (including graphs and tabular data) set forth under the headings “Corporate Governance—Corporate Governance Overview” on page 73, “Corporate Governance—Board of Directors as at 31 December 2021” on pages 74 to 75, “Corporate Governance—Senior Executive Team (SET) as at 31 December 2021” on page 76, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Board Leadership and Company Purpose” on page 77, “Corporate Governance—Corporate Governance Report—Division of responsibilities” on pages 77 to 78, “Corporate Governance—Corporate Governance Report—Remuneration” on page 78, “Corporate Governance— Science Committee Report” on page 88, “Corporate Governance—Nomination and Governance Committee Report” on pages 86 to 87, “Corporate Governance—Other Governance information—Global Compliance and Internal Audit Services (IA)” on page 79, “Corporate Governance—Annual Report on Remuneration—Governance—Directors’ service contracts and letters of appointment” on page 124, “Corporate Governance—Annual Report on Remuneration—Executive remuneration” on pages 105 to 115 and “Corporate Governance—Audit Committee Report” on pages 90 to 97, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
Please also see the information above under the heading Item 6.A “Directors and Senior Management—Senior Executive Team (SET) Biographies”.
39
D. Employees
The information set forth under the headings, “Strategic Report—Business Review—Accelerate Innovative Science—Research & Development” on pages 32 to 34, “—Responsible sales and marketing” on page 37, “—Operations” on pages 37 to 39, “Strategic Report—Business Review—Be a Great Place to Work—Our global business” (comprising the graphical data on page 43, and the “Employee relations” sections on page 43 only) and “Financial Statements—Notes to the Group Financial Statements—Note 29 —Employee costs and share plans for employees” (including the tabular data) on pages 186 to 189, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
E. Share Ownership
The information (including graphs and tabular data) set forth under the headings “Financial Statements—Notes to the Group Financial Statements—Note 29—Employee costs and share plans for employees” on pages 186 to 189, “Corporate Governance— Annual Report on Remuneration—Directors’ shareholdings” on pages 117 to 119, and “Additional Information—Directors’ Report—Directors’ and officers’ shareholdings” and “—Options to purchase securities from registrant or subsidiaries” on page 214, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A. Major Shareholders
The information set forth under the heading “Additional Information—Directors’ Report—US holdings” on page 212 and “Additional Information—Directors’ Report—Major shareholdings” (including tabular data) on page 214 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
B. Related Party Transactions
The information set forth under the headings “Financial Statements—Notes to the Group Financial Statements—Note 31—Statutory and other information—Related party transactions” on page 196, “Additional Information—Shareholder Information—Related party transactions” on page 211, “Additional Information—Directors’ Report—Issued share capital, shareholdings and share prices” on page 212, “Additional Information—Directors’ Report—US holdings” on page 212 and “Additional Information—Directors’ Report—Major shareholdings” on page 214, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
C. Interests of Experts and Counsel
Not applicable.
ITEM 8. FINANCIAL INFORMATION
A. Consolidated Statements and Other Financial Information
Please see the information below under the heading Item 18—“Financial Statements.” The information (including graphs and tabular data) set forth under the headings “Additional Information—Shareholder Information” on pages 211 to 212, “Strategic Report —Financial Review—Dividends and share repurchases” on pages 65 to 66 and “Additional Information—Directors’ Report—Distributions to shareholders-dividends for 2021” on page 214, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
Developments in Legal Proceedings
For information in respect of material legal proceedings in which AstraZeneca is currently involved, including those discussed below, please see the information (including tabular data) set forth under the heading “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments and contingent liabilities” on pages 189 to 196 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 and is incorporated by reference.
40
Patent litigation
Ultomiris
US patent proceedings
As previously disclosed, in November 2018, Chugai Pharmaceutical Co., Ltd. (Chugai) filed a lawsuit against Alexion in the Delaware District Court alleging that Ultomiris infringes a U.S. patent held by Chugai. Upon issuance of another U.S. patent in November 2019, Chugai filed a second lawsuit in the same court alleging that Ultomiris also infringes the second patent. The two lawsuits were consolidated. A trial originally scheduled to occur in January 2022 which had been postponed until February 2022 due to COVID-19, was postponed on February 14, 2022 and the case remained pending settlement discussions among the parties.
Tagrisso
US patent proceedings
As previously disclosed, in September 2021, Puma Biotechnology, Inc. and Wyeth LLC filed a patent infringement lawsuit in the US District Court for the District of Delaware against AstraZeneca relating to Tagrisso. A claim construction hearing has been scheduled for January 2023 and a trial has been scheduled for May 2024.
Patent proceedings outside the US
As previously disclosed, in Russia, in October 2021, AstraZeneca filed a lawsuit in the Arbitration Court of the Moscow Region against Axelpharm, LLC to prevent it from obtaining authorization to market a generic version of Tagrisso prior to the expiration of AstraZeneca’s patents covering Tagrisso. The lawsuit also names the Ministry of Health of the Russian Federation as a third party. In February 2022, the court dismissed the lawsuit, but has not yet issued its reasoned decision. Once the court issues its reasoned decision, AstraZeneca will evaluate the decision and consider next steps.
Commercial litigation
PARP Inhibitor Royalty Dispute
As previously disclosed, in October 2012, Tesaro, Inc (now wholly owned by GlaxoSmithKline plc (GSK)) entered into two worldwide, royalty-bearing patent license agreements with AstraZeneca related to GSK’s product niraparib. In May 2021, AstraZeneca filed a lawsuit against Tesaro in the Commercial Court of England and Wales alleging that GSK failed to pay all of the royalties due on niraparib sales under our license agreements. The case has been transferred to the Chancery Division and the trial has been listed with an anticipated start date in February 2023.
Government investigations/proceedings US 340B litigations and proceedings
As previously disclosed, in January 2021, AstraZeneca filed a separate lawsuit in federal court in Delaware (the Court) alleging that an Advisory Opinion issued by the Department of Health and Human Services violates the Administrative Procedure Act. In June 2021, the Court found in favour of AstraZeneca, invalidating the Advisory Opinion. Prior to the Court’s ruling, however, in May 2021, the US government issued new and separate letters to AstraZeneca (and other companies) asserting that our contract pharmacy policy violates the 340B statute. In July 2021, AstraZeneca amended the complaint to include allegations challenging the letter sent in May. In September 2021, the US government issued a follow-up letter to AstraZeneca (and other companies) asserting that it has referred the matter to the Office of Inspector General for further review and consideration. In October 2021, oral arguments were held before the federal court in Delaware challenging the letters sent in May and September. In February 2022, the Court found in favour of AstraZeneca, invalidating the letter sent to AstraZeneca in May.
COVID-19 Vaccine Supply and Manufacturing Inquiries
As previously disclosed, in June 2021, Argentina’s Federal Criminal Prosecutor’s Office (the Prosecutor) contacted AstraZeneca Argentina seeking documents and electronic records in connection with a local criminal investigation relating to the public procurement and supply of Vaxzevria in that country. In October 2021, the Prosecutor filed a submission with the presiding court (the Court) requesting dismissal of the criminal investigation. In February 2022, the Court ordered dismissal of the investigation, issued acquittals, and closed the proceedings.
41
B. Significant Changes
Please see the information set forth under the heading “Financial Statements—Notes to the Group Financial Statements—Note 32—Subsequent events” on page 196 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 and is incorporated by reference.
Other than as disclosed in this Item, since the date of the annual consolidated financial statements included in this Form 20-F dated February 22, 2022, no significant change has occurred.
ITEM 9. THE OFFER AND LISTING
A. Offer and Listing Details
The information (including tabular data) set forth in the introductory paragraph under the heading “Additional Information— Shareholder Information” on page 211 and “Additional Information—Shareholder Information—Ordinary Shares in issue” on page 212 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
The corresponding trading symbol is “AZN” in each of AstraZeneca’s principal markets for trading in AstraZeneca shares.
B. Plan of Distribution
Not applicable.
C. Markets
The information set forth in the introductory paragraph under the heading “Additional Information— Shareholder Information” on page 211 and “Additional Information—Shareholder Information—Issued share capital, shareholdings and share prices” on page 212 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
D. Selling Shareholders
Not applicable.
E. Dilution
Not applicable.
F. Expenses of the Issue
Not applicable.
ITEM 10. ADDITIONAL INFORMATION
A. Share Capital
Not applicable.
B. Memorandum and Articles of Association
The information set forth under the heading “Additional Information—Directors’ Report—Articles of Association” on pages 214 to 215 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
C. Material Contracts
The following is a summary of each contract (not being a contract entered into in the ordinary course of business) that has been entered into by any member of the Group: (a) within the two years immediately preceding the date of this Form 20-F which are, or may be, material to the Group; or (b) at any time which contain obligations or entitlements which is, or may be, material to the Group as at the date of this Form 20-F:
| (i) | The Merger Agreement with Alexion |
42
On December 12, 2020, AstraZeneca, Delta Omega Sub Holdings Inc., a Delaware corporation and a wholly owned subsidiary of AstraZeneca (“Bidco”), Delta Omega Sub Holdings Inc. 1, a Delaware corporation and a direct, wholly owned subsidiary of Bidco (“Merger Sub I”) and Delta Omega Sub Holdings LLC 2, a Delaware limited liability company and a direct, wholly owned subsidiary of Bidco (“Merger Sub II”) entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Alexion. The Merger Agreement provides, among other things, that subject to the satisfaction or waiver of the conditions set forth therein (1) Merger Sub I will merge with and into Alexion (the “First Merger”), with Alexion surviving the First Merger as a wholly owned subsidiary of Bidco, and (2) immediately following the effective time of the First Merger (the “Effective Time”), Alexion will merge with and into Merger Sub II (the “Second Merger” and, together with the First Merger, the “Mergers”), with Merger Sub II surviving the Second Merger as a wholly owned subsidiary of Bidco and an indirect wholly owned subsidiary of AstraZeneca.
Under the Merger Agreement, at the Effective Time (as defined in the Merger Agreement), each share of common stock, par value $0.0001 per share, of Alexion issued and outstanding immediately prior to the Effective Time (other than certain excluded shares as described in the Merger Agreement) was converted into the right to receive (1) 2.1243 American depositary shares of AstraZeneca (or, at the election of the holder thereof, a number of ordinary shares of AstraZeneca equal to the number of underlying ordinary shares represented by such American depositary shares) and (2) $60.00 in cash, without interest.
D. Exchange Controls
The information set forth under the headings “Additional Information—Shareholder Information—Exchange controls and other limitations affecting security holders” on page 212 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
E. Taxation
Taxation for US persons
The following is a summary of material UK and US federal income tax consequences of ownership of Ordinary Shares or ADRs held as capital assets by the US holders described below. This summary is based on current UK and US federal income tax law, including the current US/UK double taxation convention. This summary does not describe all of the tax consequences that may be relevant in light of the US holders’ particular circumstances (including the US Medicare contribution tax or the US alternative minimum tax) and tax consequences applicable to US holders subject to special rules. US holders and any holders who may be subject to tax in the US or the UK are urged to consult their tax advisers regarding the UK and US federal income tax consequences of the ownership and disposition of Ordinary Shares or ADRs in their particular circumstances.
This summary is based in part on representations of the depositary for ADRs and assumes that each obligation in the deposit agreement among the Company and the depositary and the holders from time to time of ADRs and any related agreements will be performed in accordance with its terms. For the purposes of this summary, the term ‘US holder’ means a beneficial owner of Ordinary Shares or ADRs that is, for US federal income tax purposes, an individual, a corporation or an estate or trust that, in each case, is treated as a US person.
For US federal income tax purposes, a holder of ADRs generally will be treated as the owner of the underlying Ordinary Shares. Accordingly, deposits or withdrawals of Ordinary Shares for ADRs will not be subject to US federal income tax.
UK and US income taxation of dividends
The UK does not currently impose a withholding tax on dividends paid by a UK company, such as the Company. Shareholders resident outside the UK will otherwise commonly not be subject to UK taxation on dividend income but should consult their own tax adviser.
For US federal income tax purposes, distributions paid by the Company to a US holder are generally included in gross income as foreign source ordinary dividend income when actually or constructively received. For any dividend paid in a foreign currency, the amount of the dividend will, in the case of ADRs, be the US dollar value of the foreign currency payment received by the depositary determined at the spot rate of the relevant foreign currency on the date the dividend is received by the depositary (or, in the case of Ordinary Shares, the US dollar value of the foreign currency payment received by the US holders, determined at the spot rate of the relevant foreign currency on the date the dividend is received by the US holders, regardless of whether the dividend is converted into US dollars). Dividends will not be eligible for the dividends received deduction generally available to US corporations.
If the dividend is converted into US dollars on the date of receipt, US holders of Ordinary Shares generally should not be required to recognise foreign currency gains or losses in respect of the dividend income. They may have foreign currency gain or loss (which would be US source and taxable at the rates applicable to ordinary income) if the amount of such dividend is converted into US dollars after the date of its receipt.
43
Subject to applicable limitations, dividends received by certain non-corporate US holders of Ordinary Shares or ADRs may be taxable at favourable US federal income tax rates. US holders should consult their own tax advisers to determine whether they are subject to any special rules which may limit their ability to be taxed at these favourable rates.
Taxation on capital gains
Under present English law, individuals or companies who are not resident in the UK will generally not be liable for UK tax on capital gains made on the disposal of their Ordinary Shares or ADRs, unless such Ordinary Shares or ADRs are used, held or acquired in connection with a trade, profession or vocation carried on in the UK through a branch or agency or other permanent establishment.
For US federal income tax purposes, a US source capital gains or losses on the sale or exchange of Ordinary Shares or ADRs in an amount equal to the difference between the US dollar amount realised and such holder’s US dollar tax basis in the Ordinary Shares or ADRs. US holders should consult their own tax advisers about the treatment of capital gains, which may be taxed at lower rates than ordinary income for non-corporate US holders, and capital losses, the deductibility of which may be subject to limitations.
Passive Foreign Investment Company (PFIC) rules
We believe that we were not a PFIC for US federal income tax purposes for the year ended 31 December 2021. However, since PFIC status depends on the composition of our income and assets, and the market value of our assets, from time to time, there can be no assurance that we will not be considered a PFIC for any taxable year. If we were treated as a PFIC, certain adverse tax consequences could apply to US holders.
Information reporting and backup withholding
Payments of dividends and sales proceeds that are made within the US or through certain US-related financial intermediaries may be subject to information reporting and backup withholding, unless, the US holder is an exempt recipient or in the case of backup withholding, the US holder provides its taxpayer identification number and certifies that it is not subject to backup withholding. The amount of any backup withholding from a payment to a US holder will be allowed as a credit against the holder’s US federal income tax liability and may entitle the holder to a refund, provided that the required information is timely supplied to the US Internal Revenue Service.
Certain US holders who are individuals (or certain specified entities) may be required to report information relating to securities issued by non-US persons (or foreign accounts through which the securities are held), subject to certain exceptions (including an exception for securities held in accounts maintained by US financial institutions). US holders should consult their tax advisers regarding their reporting obligations.
UK inheritance tax
Ordinary Shares or ADRs held by an individual who is domiciled in the US for the purposes of the United States – United Kingdom Double Taxation Convention relating to estate and gift taxes (the Estate Tax Convention), and who is not for such purposes a national of the UK, will generally not be subject to UK inheritance tax on the individual’s death or on a lifetime transfer of the Ordinary Shares or ADRs, provided that any applicable US federal gift or estate tax liability is paid, except in certain cases where the Ordinary Shares or ADRs: (i) are comprised in a settlement (unless, at the time of the settlement, the settlor was domiciled in the US and not a national of the UK); (ii) are part of the business property of a UK permanent establishment of an enterprise; or (iii) pertain to a UK fixed base of an individual used for the performance of independent personal services. In the exceptional case where the Ordinary Shares or ADRs are subject to both UK inheritance tax and US federal gift or estate tax, the Estate Tax Convention generally provides for double taxation to be relieved by means of credit relief.
UK stamp duty reserve tax and stamp duty
A charge to UK stamp duty or UK stamp duty reserve tax (SDRT) may arise on the deposit of Ordinary Shares in connection with the creation of ADRs. The rate of stamp duty or SDRT will generally be 1.5% of the value of the consideration or, in some circumstances, the value of the Ordinary Shares. Under current HMRC practice, this charge will not be applied on the issue (or, where it is integral to the raising of new capital, the transfer) of Ordinary Shares into the ADR arrangement.
Transfers of Ordinary Shares into CREST will generally not be subject to stamp duty or SDRT, unless such a transfer is made for a consideration in money or money’s worth, in which case a liability to stamp duty or SDRT will arise, usually at the rate of 0.5% of the value of the consideration.
44
A transfer of, or an agreement to transfer, Ordinary Shares (whether within or outside CREST) will generally be subject to UK stamp duty or SDRT at 0.5% of the amount or value of any consideration (in the case of stamp duty, this will be rounded up to the nearest £5). The purchaser would usually pay this duty. No UK stamp duty or SDRT will be payable on the acquisition or transfer of existing ADRs provided that there is no written instrument of transfer.
F. Dividends and Paying Agents
Not applicable.
G. Statement by Experts
Not applicable.
H. Documents on Display
The Company’s Articles of Association and other documents concerning the Company which are referred to in this Form 20-F dated February 22,2022, may be inspected at the Company’s registered office at 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge CB2 0AA, UK.
I. Subsidiary Information
Not applicable.
ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The information (including graphs and tabular data) set forth under the headings “Strategic Report—Financial Review—Financial risk management” on page 66 and “Financial Statements—Notes to the Group Financial Statements—Note 28—Financial risk management objectives and policies” on pages 180 to 186, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
A. Debt Securities
Not applicable.
B. Warrants and Rights
Not applicable.
C. Other Securities
Not applicable.
45
D. American Depositary Shares
Fees and Charges Payable by ADR Holders
The Company’s American Depositary Receipt (“ADR”) program is administered by Deutsche Bank Trust Company Americas (“DBTCA” or the “Depositary”), as the depositary. The holder of an ADR may have to pay the following fees and charges to DBTCA in connection with ownership of the ADR:
Category |
| Depositary actions |
| Associated fee or charge | ||
(a) Depositing or substituting the underlying shares | Issuances upon deposits of shares (excluding issuances as a result of stock distributions or the exercise of rights) | Up to $5.00 for each 100 ADSs (or fraction thereof) issued | ||||
(b) Receiving or distributing dividends (1) | Distributions of stock dividends or other free stock distributions, cash dividends or other cash distributions (i.e., sale of rights and other entitlements), distributions of securities other than ADSs or rights to purchase additional ADSs | Up to $5.00 for each 100 ADSs (or fraction thereof) | ||||
(c) Selling or exercising rights | The exercise of rights to purchase additional ADSs | Up to $5.00 for each 100 ADSs (or fraction thereof) | ||||
(d) Withdrawing, cancelling or reducing an underlying security | Surrendering ADSs for cancellation and withdrawal of deposited property | Up to $5.00 for each 100 ADSs (or portion thereof) surrendered or cancelled (as the case may be) | ||||
(e) Transferring, combination or split-up of receipts | Not applicable. | |||||
(f) General depositary services, particularly those charged on an annual basis(1) | Depositary services fee | A fee not in excess of $5.00 per 100 ADSs (or fraction thereof) held on the applicable record date(s) established by the Depositary. | ||||
(g) Fees and expenses of the depositary | Fees and expenses incurred by the Depositary or the Depositary’s agents on behalf of holders, including in connection with: · taxes (including applicable interest and penalties) and other governmental charges · registration of shares or other deposited securities on the share register and applicable to transfers of shares or other deposited securities to or from the name of the custodian, the Depositary or any nominees upon the making of deposits and withdrawals, respectively; · cable, telex and facsimile transmission and delivery expenses · expenses and charges incurred by the Depositary in conversion of foreign currency into U.S. dollars · compliance with exchange control regulations and other regulatory | As incurred by the Depositary. | ||||
requirements applicable to the shares, deposited securities, ADSs and ADRs · the fees and expenses incurred by the Depositary, the custodian, or any nominee in connection with the delivery or servicing of deposited property (as defined in the Deposit Agreement) | ||||||
| (1) | $0.03 per ADR annually |
Fees and Payments Made by DBTCA to Us
Pursuant to the deposit agreement, the Depositary may charge a fee up to $0.05 per ADR in respect of dividends paid by us. For the year ended December 31, 2021, we agreed that the Depositary could charge an annual fee of $0.03 per ADR in respect of dividends paid by us. As at December 31, 2021, we have received approximately $12.84 million arising out of fees charged in respect of dividends paid during 2021 and $15 million as a (further) contribution to the Company’s ADR program costs. We also have an agreement with the Depositary that it will waive a certain amount of its fees for standard costs associated with the administration of the ADR program up to $10,000 per year.
46
PART II
ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
Not applicable.
ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
Not applicable.
ITEM 15. CONTROLS AND PROCEDURES
| A. | Internal Controls and Procedures |
The information set forth under the heading “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Risk Management and Controls” on page 79, Corporate Governance Report—Audit Committee Report—Other information” on page 96, “Corporate Governance—Audit Committee Report—Internal Controls” on page 96, and “Financial Statements—Directors’ Annual Report on Internal Controls over Financial Reporting” on page 126, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
US corporate governance requirements
The Company’s ADRs are traded on the Nasdaq and, accordingly, it is subject to the reporting and other requirements of the SEC applicable to foreign private issuers. Section 404 of the Sarbanes-Oxley Act requires companies to include in their annual report on Form 20-F filed with the SEC, a report by management stating its responsibility for establishing internal control over financial reporting and to assess annually the effectiveness of such internal control. The Company has complied with those provisions of the Sarbanes-Oxley Act applicable to foreign private issuers.
B. Management’s Annual Report on Internal Control over Financial Reporting
As required by U.S. regulations, management is responsible for establishing and maintaining adequate internal control over financial reporting for the Company, and is required to identify the framework used to evaluate the effectiveness of the Company’s internal control over financial reporting and to assess the effectiveness of such internal control. In this regard, management has made the same assessment and reached the same conclusion as that set forth in the section entitled “Financial Statements—Directors’ Annual Report on Internal Controls over Financial Reporting” on page 126 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022, which is incorporated by reference.
C. Report of Independent Registered Public Accounting Firm
The effectiveness of the Company’s internal control over financial reporting as of December 31, 2021 has been audited by PricewaterhouseCoopers LLP, independent registered public accounting firm, as stated in their report dated February 10, 2021, which is included below under the heading Item 18—“Financial Statements—Report of Independent Registered Public Accounting Firm”.
D. Changes to Internal Controls
Based on the evaluation conducted, management has concluded that no such changes have occurred that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
ITEM 16. RESERVED
ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT
The information set forth under the heading “Corporate Governance—Audit Committee Report—Committee membership and meeting attendance in 2021” on page 73 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
ITEM 16B. CODE OF ETHICS
The information set forth under the headings “Strategic Report—Business Review—Be a Great Place to Work—Code of Ethics” on page 47, “Corporate Governance—Corporate Governance Report—Other Governance information—Risk Management and Controls—Global Compliance and Internal Audit Services (IA)” on page 79 and “Corporate Governance—
47
Audit Committee Report—Legal and Compliance” on pages 91 to 92, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference. AstraZeneca’s Code of Ethics is available within the ‘Ethics and transparency’ section of our website at www.astrazeneca.com/sustainability/ethics-and-transparency.html.
ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The following table sets forth the aggregate fees for professional services rendered by PricewaterhouseCoopers LLP in 2021 and 2020:
Year ended December 31, | ||||
| 2021 | 2020 | ||
($million) | ||||
Audit fees |
| 28.6 |
| 19.5 |
Audit-related fees |
| 3.6 |
| 0.3 |
All other fees |
| 3.7 |
| 0.5 |
Total |
| 35.9 |
| 20.3 |
Audit fees included $15.2 million for the audit of subsidiaries pursuant to legislation (2020: $10.8 million), $10.5 million for the Group audit (2020: $6.3 million), $0.9 million for assurance services in relation to interim financial statements (2020: $0.4 million) and $2.0 million in respect of section 404 of the Sarbanes-Oxley Act (2020: $2.0 million). $0.4 million of Audit fees payable in 2021 are in respect of the Group audit and audit of subsidiaries related to prior years ($0.8 million of Audit fees payable in 2020 are in respect of the 2019 Group audit and audit of subsidiaries).
Audit-related fees included $3.0 million for services provided in relation to the acquisition of Alexion and related debt issuance and $0.6 million for other audit-related services.
All other fees included $0.3 million for the audit of subsidiaries’ pension schemes (2020: $0.3 million), and $3.4 million (2020: $0.2 million) for other assurance services. Included in All other fees are $3.1 million of services provided in relation to the acquisition of Alexion and related debt issuance.
$0.3 million of Audit fees and $0.7 million of Audit-related fees relate to pre-acquisition fees incurred by Alexion.
The information (including tabular data) set forth under the heading “Corporate Governance—Audit Committee Report” on pages 90 to 97 of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2022 is incorporated by reference.
U.S. law and regulations permit the Audit Committee pre-approval requirement to be waived with respect to engagements for non-audit services aggregating to no more than five percent of the total amount of revenues paid by AstraZeneca to its principal accountants, if such engagements were not recognized by AstraZeneca at the time of engagement and were promptly brought to the attention of the Audit Committee or a designated member thereof and approved prior to the completion of the audit. In 2021 and 2020, the percentage of the total amount of revenues paid by AstraZeneca to its principal accountant for non-audit services in each category that was subject to such a waiver was less than five per cent for each year.
ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES
Not applicable.
48
ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS
(d) Maximum | ||||||||
|
|
| Number (or | |||||
|
|
| (c) Total Number of |
| Approximate Dollar | |||
|
|
| Shares (or Units) |
| Value) of Shares (or | |||
(a) Total number of | (b) Average Price |
| Purchased as Part of |
| Units) that May Yet | |||
Shares (or Units) | Paid per |
| Publicly Announced Plans or |
| Be Purchased Under | |||
Period |
| Purchased |
| Share (or Unit) |
| Programs |
| the Plans or Programs |
|
| ($) | ($ billion) | |||||
Month #1 Jan 1 - Jan 31 |
| 0 |
| N/A |
| 0 |
| 0 |
Month #2 Feb 1 - Feb 28 |
| 0 |
| N/A |
| 0 |
| 0 |
Month #3 Mar 1 - Mar 31 |
| 0 |
| N/A |
| 0 |
| 0 |
Month #4 Apr 1 - Apr 30 |
| 0 |
| N/A |
| 0 |
| 0 |
Month #5 May 1 - May 31 |
| 0 |
| N/A |
| 0 |
| 0 |
Month #6 Jun 1 - Jun 30 |
| 0 |
| N/A |
| 0 |
| 0 |
Month #7 Jul 1 - Jul 31 |
| 0 |
| N/A |
| 0 |
| 0 |
Month #8 Aug 1 - Aug 31 |
| 0 |
| N/A |
| 0 |
| 0 |
Month #9 Sep 1 - Sep 30 |
| 0 |
| N/A |
| 0 |
| 0 |
Month #10 Oct 1 - Oct 31 |
| 0 |
| N/A |
| 0 |
| 0 |
Month #11 Nov 1 - Nov 30 |
| 0 |
| N/A |
| 0 |
| 0 |
Month #12 Dec 1 - Dec 31 |
| 0 |
| N/A |
| 0 |
| 0 |
Total |
| 0 |
| N/A |
| 0 |
| 0 |
There have been no share repurchases since October 1, 2012, when the Company announced the suspension of its share repurchase program. At the 2020 Annual General Meeting the Company’s shareholders authorized the Company to repurchase 131,220,627 of its own shares, but the Company’s Board of Directors did not lift the suspension on share repurchases and, accordingly, the Company did not repurchase any of its shares in 2021.
ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT
Not applicable.
ITEM 16G. CORPORATE GOVERNANCE
The Company is a public limited company incorporated in England and Wales, admitted to the premium segment of the Official List of the Financial Conduct Authority (“FCA”) and to trading on the main market of the London Stock Exchange. As a result, it follows the U.K. Corporate Governance Code (the “U.K. Code”) in respect of its corporate governance practices. The 2019 edition of the U.K. Code came into effect for reporting periods beginning on or after January 1, 2020 and was effective to the Company for the year ended December 31, 2021. The Companies Act 2006 (the “U.K. Act”) and the Listing Rules of the U.K. Financial Conduct Authority (the “FCA Rules”) imposes certain requirements that also influence the Company’s corporate governance practices. The Company has ADRs listed on the Nasdaq Stock Exchange and, under the Nasdaq Listing Rules applicable to listed companies, as a foreign private issuer, the Company is permitted to follow the corporate governance practice of its home country in lieu of certain provisions of the Nasdaq Listing Rules.
The Company is required to disclose any significant ways in which its corporate governance practices differ from those followed by US companies under the Nasdaq Corporate Governance Requirements. In addition, the Company must comply fully with the provisions of the Nasdaq Corporate Governance Requirements relating to the composition, responsibilities and operation of audit committees, applicable to foreign private issuers. These provisions incorporate the rules concerning audit committees implemented by the SEC under the Sarbanes-Oxley Act. The Company has reviewed the corporate governance practices required to be followed by US companies under the Nasdaq Corporate Governance Requirements and its corporate governance practices are generally consistent with those standards.
49
A summary of the significant ways in which the Company’s corporate governance practices differ from those followed by U.S. domestic companies under the Nasdaq Standards is set forth below.
Nasdaq Listing Rules |
| AstraZeneca Corporate Governance Practice |
1. Under the Nasdaq Listing Rules, the audit committee is to be directly responsible for the appointment, compensation, retention and oversight of a listed company’s external auditor. | Under the U.K. Act, a company’s external auditors are appointed by its shareholders, or in limited circumstances, by the directors of the company or the Secretary of State. Under the U.K. Code, a company’s audit committee is responsible for, amongst other things: conducting the tender process and making recommendations to the board, about the appointment, reappointment and removal of the external auditor, and approving the remuneration and terms of engagement of the external auditor; reviewing and monitoring the external auditor’s independence and objectivity; reviewing the effectiveness of the external audit process, taking into consideration relevant U.K. professional and regulatory requirements; and developing and implementing policy on the engagement of the external auditor to supply non-audit services. In the event that the board does not accept the audit committee’s recommendation on the external auditor appointment, reappointment or removal, a statement from the audit committee explaining its recommendation and the reasons why the board has taken a different position should be included in the company’s annual report. This should also be included in any papers recommending appointment or reappointment. | |
2. Under the Nasdaq Listing Rules, each listed company must have a formal written compensation committee charter that specifies (A) the compensation committee’s responsibility for determining, or recommending to the board for determination, the compensation of the chief executive officer and all other Executive Officers of the company, and (B) that the chief executive officer may not be present during voting or deliberations on his or her compensation. | Under the U.K. Code, the Company’s Remuneration Committee determines the Company’s global remuneration frameworks and principles, approves individual salary decisions and related matters for executive members of the Company’s Board of Directors, the Senior Executive Team and the Company Secretary, and reviews annual bonus payments for all executives reporting directly to the Senior Executive Team members. While the Remuneration Committee does not make initial recommendations to the Board of Directors in this respect, it does report to the Board of Directors on these matters. Under the U.K. Act, the Company is required to offer shareholders: (i) a binding vote on the Company’s forward looking remuneration policy for its directors at least every three years; and (ii) a separate annual advisory vote on the implementation of the Company’s existing remuneration policy in terms of the payments and share awards made to its directors during the year, which is disclosed in an annual remuneration report. The U.K. Code does not require that the terms of reference of the Company’s Remuneration Committee specify that the chief executive officer may not be present during voting or deliberations on his or her compensation. | |
3. Under the Nasdaq Listing Rules, each listed company must have a compensation committee comprised of at least two members each of whom must be an Independent Director, as defined under Listing Rule 5605(a)(2). | Under the U.K. Code, all of the members of the Company’s Remuneration Committee should be independent non-executive directors, with a minimum membership of three. Under the U.K. Code, the chairman of the Company may be a member, but not chair, of the Remuneration Committee, provided he or she was considered independent on appointment as chairman. In addition, the chair of a company’s remuneration committee should have served for at least 12 months on a remuneration committee before his or her appointment. | |
4. Under the Nasdaq Listing Rules, director nominees must either be selected, or recommended for the Board’s selection, either by (A) Independent Directors constituting a majority of the Board’s Independent Directors in a vote in which only Independent Directors participate, or (B) a nominations committee comprised solely of Independent Directors. | Under the U.K. Code, a majority of the members of the Company’s nomination committee should be independent non-executive directors. Under the U.K. Code, the chairman of the Company may be a member or chair of the nomination committee, provided he or she was considered independent on appointment as chairman. However, the chairman of the board may not chair the nomination committee when it is dealing with the appointment of his or her successor. | |
5. Under the Nasdaq Listing Rules, the by-laws of a listed company, other than a limited partnership, must provide for a quorum requirement for shareholder meetings of not less than 331/3% of the outstanding shares of voting common stock. | Under the U.K. Act, if a company’s articles of association do not provide otherwise, two qualifying persons must be present at a meeting for a valid quorum, unless they are both representatives of the same corporation or have been appointed as proxies by the same shareholder. The Company’s Articles of Association contain a similar requirement. | |
6. Under the Nasdaq Listing Rules, subject to certain exceptions, shareholder approval is required prior to the issuance of securities when a stock option or purchase plan is to be established or materially amended or other equity compensation arrangement made or materially amended, pursuant to which stock may be acquired by officers, directors, employees, or consultants. | Under the FCA Rules, shareholder approval is required to be obtained by the Company for the adoption of equity compensation plans which are either long-term incentive schemes in which directors of the Company can participate or schemes which may involve the issue of new shares. Under the FCA Rules, these plans may not be changed to the benefit of the plan participants unless shareholder approval is obtained (with certain minor exceptions, for example, to benefit the administration of the plan or to take account of tax benefits). |
Board Diversity Matrix (as of February 22, 2022)
Country of Principal Executive Offices: |
| England and Wales |
|
Foreign Private Issuer | Yes | ||
Disclosure Prohibited Under Home Country Law | No | ||
Total Number of Directors | 13 |
| Female |
| Male |
| Non-Binary |
| Did Not Disclose Gender | |
Part 1: Gender Identity |
|
|
|
| ||||
Directors | 5 | 8 | - | - | ||||
Part II: Demographic Background |
|
| ||||||
Underrepresented Individual in Home Country Jurisdiction |
| 4 | ||||||
LGBTQ+ |
| - | ||||||
Did Not Disclose Demographic Background |
| - | ||||||
ITEM 16H. MINE SAFETY DISCLOSURE
Not applicable.
50
ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
PART III
ITEM 17. FINANCIAL STATEMENTS
The Company has responded to Item 18 in lieu of this item.
ITEM 18. FINANCIAL STATEMENTS
The information (including tabular data) set forth under the headings “Financial Statements” on pages 125 to 196 (excluding the information set forth under the subheadings “Independent Auditors’ Report to the Members of AstraZeneca PLC” on pages 127 to 133) and “Financial Statements—Group Financial Record” on page 209, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2021” included as exhibit 15.1 to this Form 20-F dated February 22, 2021 is incorporated by reference.
51
ITEM 19. EXHIBITS(1)
1.1 |
| |
2.1 | ||
4.1 | ||
4.2 | Employment Agreement between AstraZeneca UK Limited and Aradhana Sarin, dated August 1, 2021. | |
4.3 | ||
4.4 | ||
4.5 | ||
8.1 | ||
12.1 | ||
12.2 | ||
13.1 | ||
15.1 | ||
15.2 | Consent of PricewaterhouseCoopers LLP, independent registered public accounting firm. | |
15.3 | ||
15.4 | ||
101.INS | Inline XBRL Instance Document. | |
101.SCH | Inline XBRL Taxonomy Extension Schema. | |
101.CAL | Inline XBRL Taxonomy Extension Scheme Calculation Linkbase. | |
101.DEF | Inline XBRL Taxonomy Extension Scheme Definition Linkbase. | |
101.LAB | Inline XBRL Taxonomy Extension Scheme Label Linkbase. | |
101.PRE | Inline XBRL Taxonomy Extension Scheme Presentation Linkbase. | |
104 | Cover page interactive data file (formatted as Inline XBRL and included in Exhibit 101) |
| (1) | Exhibits other than those listed above are omitted when in the opinion of the registrant they are either not applicable or not material. Other Exhibits previously filed have been omitted when in the opinion of the registrant such Exhibits are no longer material. |
| (2) | Certain of the information included within Exhibit 15.1, which is provided pursuant to Rule 12b-23(a)(3) of the Securities Exchange Act of 1934, as amended, is incorporated by reference in this Form 20-F, as specified elsewhere in this Form 20-F. With the exception of the items and pages so specified, the Annual Report and Form 20-F Information 2021 is not deemed to be filed as part of this Annual Report on Form 20-F. |
52
SIGNATURE
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report on its behalf.
AstraZeneca PLC | ||
By: | /s/ Adrian Kemp | |
Name: | Adrian Kemp | |
Title: | Company Secretary | |
London, England | ||
February 22, 2022 | ||
53
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
INDEX TO FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm (PCAOB ID | F-2 | |
F-7 | ||
F-8 | ||
F-9 | ||
F-10 | ||
F-11 | ||
F-18 |
F-1
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of AstraZeneca PLC
Opinions on the financial statements and internal control over financial reporting
We have audited the accompanying Consolidated Statement of Financial Position of AstraZeneca PLC and its subsidiaries (the “Company”) as of 31 December 2021, 31 December 2020 and 31 December 2019, and the related Consolidated Statement of Comprehensive Income, Consolidated Statement of Changes in Equity and Consolidated Statement of Cash Flows for each of the three years in the period ended 31 December 2021, the Group Accounting Policies and the related notes (collectively referred to as the “consolidated financial statements”). We also have audited the Company’s internal control over financial reporting as of 31 December 2021, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of 31 December 2021, 31 December 2020 and 31 December 2019, and the results of its operations and its cash flows for each of the three years in the period ended 31 December 2021 in accordance with (i) International Financial Reporting Standards as issued by the International Accounting Standards Board, (ii) UK-adopted International Accounting Standards, and (iii) International Financial Reporting Standards as adopted by the European Union. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of 31 December 2021, based on criteria established in Internal Control - Integrated Framework (2013) issued by the COSO.
Basis for opinions
The Company’s management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in the Directors’ Annual Report on Internal Controls over Financial Reporting. Our responsibility is to express opinions on the Company’s consolidated financial statements and on the Company’s internal control over financial reporting based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects.
Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.
As described in the Directors’ Annual Report on Internal Controls over Financial Reporting, management has excluded Alexion Pharmaceuticals Inc. from its assessment of internal control over financial reporting as of 31 December 2021 because it was acquired by the Company in a purchase business combination during 2021. We have also excluded Alexion Pharmaceuticals Inc. from our audit of internal control over financial reporting. Alexion Pharmaceuticals Inc. is a wholly-owned subsidiary whose total assets, excluding the effects of purchase accounting, and total revenues excluded from management’s assessment and our audit of internal control over financial reporting represent approximately 9% and 8%, respectively, of the related consolidated financial statement amounts as of and for the year ended 31 December 2021.
Definition and limitations of internal control over financial reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorisations of management and directors of the
F-2
company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorised acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Critical audit matters
The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the Audit Committee and that (i) relate to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgements. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Recognition and measurement of accruals for certain rebates in the US (excluding rare diseases)
As described in the Group Accounting Policies, Note 1 and Note 20 to the consolidated financial statements, in the US the Company sells to customers under various commercial and government mandated contracts and reimbursement arrangements that include rebates, of which the most significant are Medicaid, Medicare Part D, and Managed Care. Unsettled amounts are accrued and an accrual of $3,172m was determined to be necessary as at 31 December 2021 for rebates on all US product sales (which includes an immaterial amount for rare diseases). The methodology and assumptions used to estimate rebates and returns are monitored and adjusted regularly in the light of contractual and legal obligations, historical trends, past experience and projected market conditions.
The principal considerations for our determination that performing procedures related to recognition and measurement of accruals for certain rebates in the US (excluding rare diseases) is a critical audit matter are the significant estimates made by management. There is estimation uncertainty involved in determining the Medicaid, Medicare Part D, and Managed Care accruals, as the reserves are based on assumptions developed using contractual and mandated terms with customers, historical experience, and market related information in the US. This in turn led to a high degree of auditor judgement and subjectivity in applying procedures relating to these assumptions.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to the assumptions used to estimate the accruals for the Medicaid, Medicare Part D, and Managed Care arrangements. These procedures also included, among others, (i) developing an independent expectation of these accruals using the terms of the specific rebate programmes, third party information on prices and market conditions in the US and the historical trend of actual rebate claims paid; (ii) comparing our independent estimate to management’s estimates recorded by the Company; (iii) assessing the historical accuracy of the Company’s estimates in previous years and the effect of any adjustments to prior years’ accruals in the current year’s results; and (iv) testing rebate claims processed by the Company, including evaluating those claims for consistency with the contractual and mandated terms of the Company’s arrangements.
Impairment assessment of the product, marketing and distribution rights and other intangibles (excluding goodwill and software development costs)
As described in the Group Accounting Policies and Note 10 to the consolidated financial statements, the Company has product, marketing and distribution rights and other intangibles (hereafter the intangible assets) totalling $41,314 million and $748 million, respectively, at 31 December 2021. Those intangible assets under development and not available for use are tested annually for impairment and other intangible assets are tested when there is an indication of impairment loss or reversal. The recoverability of the carrying values of cash generating units (to which the intangible assets belong) depends on future cash flows and/or the outcome of research and development activities including decisions by the Company to terminate development. The determination of the recoverable amounts includes significant estimates which are highly sensitive and depend upon key assumptions including the probability of technical and regulatory success and amount and timing of projected future cash flows (in particular peak year sales and sales erosion curves). Changes in these assumptions could have an impact on the recoverable amount of intangible assets. During 2021, $2,085 million of impairment charges were recorded (of which $1,464 million was recorded in Research and development expenses and $621million within Selling, general and administrative costs) as a result of the impairment reviews conducted by management. There is limited headroom in the recoverable amount calculation for those partially impaired assets and they are inherently sensitive to any variations in assumptions, which could give rise to future impairments. For one material asset (Ardea, $1,172 million) full impairment was recorded following the decision to discontinue development of verinurad.
The principal considerations for our determination that performing procedures related to the product, marketing and distribution rights and other intangibles is a critical audit matter are the significant estimates made by management in
F-3
determining the recoverable amount of the Company’s individual assets or cash generating units. This in turn led to a high degree of auditor judgement, subjectivity, and effort in performing procedures to evaluate management’s cash flow projections including significant assumptions related to probability of technical and regulatory success, and the amount and timing of projected future cash flows (in particular peak year sales and sales erosion curves). Additionally, the audit effort involved the use of professionals with specialised skill and knowledge to assist in evaluating the valuation techniques used and certain significant assumptions (including the probability of technical and regulatory success).
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to management’s process for the determination of recoverable amounts of the Company’s individual assets or cash generating units, and their related assessment of the impairment of intangible assets. These procedures also included, among others, (i) testing management’s process for identifying indicators for impairment and determining the recoverable amount of the Company’s individual assets or cash generating units, including for one material asset where management’s determination was that there was no recoverable value; (ii) evaluating the appropriateness of the methodology used in the impairment models; (iii) testing the completeness and accuracy of the models as well as the underlying data used in the models, including reconciling the cash flows to the Board approved Medium and Long Term Plans; and (iv) evaluating the significant assumptions used by management in determining future cash flows, including the probability of technical and regulatory success, peak year sales and sales erosion curves. Evaluating the reasonableness of management’s assumptions involved (a) comparing significant assumptions (including management’s probability of technical and regulatory success, peak year sales assumptions and sales erosion curves) to external data and benchmarks; and (b) performing a retrospective comparison of forecasted revenues to actual past performance. Professionals with specialised skill and knowledge were used to assist in the evaluation of valuation techniques used and certain significant assumptions (including the probability of technical and regulatory success).
Recognition and measurement of legal provisions and legal proceedings contingent liabilities
As described in the Group Accounting Policies, Note 21 and Note 30 to the consolidated financial statements, the Company is involved in various legal proceedings considered typical to its business, including actual or threatened litigation relating to product liability, commercial disputes, infringement of IP rights and the validity of certain patents and completion laws. As at 31 December 2021 the Company held provisions of $239 million in respect of legal claims and settlements (together, legal provisions) and disclosed the more significant legal proceedings as contingent liabilities in Note 30. Management’s assessment as to whether or not to recognise legal provisions involves a series of complex judgements about future events and relies heavily on estimates and assumptions. Provisions are recorded by management where an adverse outcome is probable and associated costs, including related legal costs, can be estimated reliably. In other cases, appropriate disclosures are included. Determining the timing of recognition of when an adverse outcome is probable is considered a key judgement
The principal considerations for our determination that performing procedures related to recognition and measurement of legal provisions and legal proceedings contingent liabilities is a critical audit matter are the significant judgement by management when assessing the probability of an adverse outcome and in determining a reasonable estimate of the loss or range of loss for each claim. This led to a high degree of auditor judgement and subjectivity in evaluating management’s assessment of the legal provisions necessary and contingent liabilities disclosed in respect to the legal claims.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to management’s evaluation of legal claims, including controls over determining whether a loss is probable (and if applicable estimation of the related legal provision) and financial statement disclosures. These procedures also included, among others, (i) obtaining and evaluating letters of audit inquiry with internal and external legal counsel; (ii) testing the completeness of management’s assessment of both the identification of legal claims and possible outcomes of each significant legal claim; (iii) evaluating the reasonableness of management’s assessment regarding whether it is probable that a liability exists and a reliable estimate can be made of the likely outcome; and (iv) evaluating the sufficiency of the Company’s legal proceedings contingent liabilities disclosures.
Recognition and measurement of accruals for tax contingencies
As described in the Group Accounting Policies and Note 30 to the consolidated financial statements, the Company recorded accruals of $768m in respect of tax contingencies at 31 December 2021. The Company faces a number of audits and reviews in jurisdictions around the world and, in some cases, is in dispute with the tax authorities. Accruals for tax contingencies require management to make key judgements with respect to the ultimate outcome of current and potential future tax audits. Where the tax exposures can be quantified, an accrual is made based on either the most likely amount method or the expected value method. Accruals can be built up over a long period of time but the ultimate resolution of tax exposures usually occurs at a point in time. Given the inherent uncertainties in management’s assessments of the outcomes of these exposures, there could, in future periods, be adjustments to these accruals that have a material positive or negative effect on the results in any particular period.
F-4
The principal considerations for our determination that performing procedures related to recognition and measurement of accruals for tax contingencies is a critical audit matter is the significant judgement made by management in determining accruals for tax contingencies, including significant estimation uncertainty relative to the tax audits and reviews in jurisdictions around the world and in some cases disputes with the tax authorities, and the potential for adjustments which could have a material impact on the Company’s profit for the year. This in turn led to a high degree of auditor judgement, effort, and subjectivity in performing procedures to evaluate the timely identification and accurate measurement of accruals for tax contingencies, as the nature of the audit evidence available to support the accruals for tax contingencies is complex and often highly subjective, and the audit effort involved the use of professionals with specialised skill and knowledge to assist in evaluating the audit evidence obtained.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to the identification, recognition and measurement of tax contingencies. These procedures also included, among others, (i) testing the information used in the determination of the probability of different outcomes for tax contingencies; (ii) testing the estimation of the accruals for tax contingencies by jurisdiction, including management’s assessment of the technical merits of tax positions (including where relevant evaluating any advice received from the Company’s external advisors) and estimates of the amount of tax benefit expected to be sustained; (iii) testing the completeness of management’s assessment of both the identification of tax contingencies and possible outcomes of each tax contingency; (iv) evaluating the status and results of tax audits and enquiries with the relevant tax authorities; and (v) assessing the sufficiency of the disclosures in Note 30. Professionals with specialised skill and knowledge were used to assist in the evaluation of the completeness and measurement of the Company’s accruals for tax contingencies, including evaluating the reasonableness of management’s assessment of whether tax positions are more-likely-than-not of being sustained and the amount of potential benefit to be realised, the application of relevant tax laws, and estimated interest and penalties.
Valuation of defined benefit obligations
As described in the Group Accounting Policies and Note 22 to the consolidated financial statements, the Company has defined benefit obligations of $13,018 million at 31 December 2021 mainly in the UK and Sweden. Management’s qualified independent actuaries update the actuarial valuations under IAS 19 for the major defined benefit schemes. The assumptions which have the most material impact on the financial position of the Group were inflation, rate of increase in salaries, rate of increase in pensions in payment and discount rate.
The principal considerations for our determination that performing procedures related to the valuation of defined benefit obligations is a critical audit matter are the significant estimates made by management, and the use of management’s specialists, in determining the assumptions which can have a material impact on the defined benefit obligations. This in turn led to a high degree of auditor judgement and subjectivity in applying procedures relating to these assumptions and the audit effort involved the use of professionals with specialised skill and knowledge to assist in evaluating those assumptions.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to the assumptions used to determine the defined benefit obligations and the accuracy of the obligations. These procedures, which involved professionals with specialised skill and knowledge to assist in evaluating the reasonableness of the assumptions used in calculating the defined benefit obligations for the UK and Sweden, also included, among others, (i) assessing whether mortality assumptions were consistent with the specifics of each plan and, where applicable, with relevant independently developed ranges considering national information; (ii) evaluating that the discount and inflation rates used were consistent with independently developed ranges and in line with other companies’ recent external reporting; (iii) assessing management’s methodology used to determine the discount rate and inflation assumptions to ensure that this is in line with the requirements of IAS 19 ‘Employee Benefits’ and that any changes in methodologies were appropriate; and (iv) evaluating the calculations prepared by management’s specialists to assess the impact of the assumptions used on the consolidated financial statements.
Acquisition of Alexion Pharmaceuticals Inc. - valuation of the acquired intangible assets and inventory
As described in Note 27 to the consolidated financial statements, on 21 July 2021 the Company acquired Alexion Pharmaceuticals Inc. for consideration of $41,058 million. The Company has recorded the assets and liabilities acquired at fair value which resulted in the recognition of $26,855 million of intangible assets and $6,769 million of inventory. Attributing fair values to assets acquired and liabilities assumed as part of business combinations is considered to be a key judgement in the purchase price allocation. The intangible assets were fair valued using the multi-period excess earnings method, which uses a number of estimates regarding the amount and timing of future cash flows. The key assumptions in the future cash flows are probability of regulatory and technical success (PTRS), peak year sales and revenue erosion curves. The fair value of inventory was calculated as the estimated selling price less estimated costs to complete and sell the inventory, the associated margins on these activities and holding costs. The purchase price allocation was performed with assistance from an independent valuer to advise on the valuation techniques and key assumptions in the valuation, in particular in respect of the valuation of the intangible assets and inventory.
F-5
The principal considerations for our determination that performing procedures related to the acquisition of Alexion Pharmaceuticals Inc. - valuation of the acquired intangible assets and inventory is a critical audit matter are the significant judgement made by management in (i) determining the future cash flow projections and significant assumptions related to PTRS, the amount and timing of projected future cash flows (in particular peak year sales and sales erosion curves) to fair value the intangible assets; and (ii) estimating the selling price, costs to complete and sell the inventory and the associated margins, of inventory. This in turn led to a high degree of auditor judgement, subjectivity, and effort in performing procedures and evaluating audit evidence over key assumptions to evaluate the above. The audit effort involved the use of professionals with specialised skill and knowledge to assist in evaluating the assumptions used in the valuation of intangible assets and inventory.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to management’s process for the determination of the fair value of the assets and liabilities acquired in the business combination. These procedures also included, among others, (i) assessing management’s process and methodology for estimating the fair value of the acquired intangible assets and inventory, including evaluating the appropriateness of the valuation methods used by management’s specialists; (ii) testing the completeness and accuracy of the models as well as the underlying data used in the determination of the fair value of the intangible assets and inventory; (iii) considering whether the assumptions around the costs to complete and sell inventory are consistent with audit evidence obtained for other areas of the business; and (iv) for the intangible assets evaluating the significant assumptions used by management in determining future cash flows, including the PTRS, peak year sales and sales erosion curves. Evaluating the reasonableness of management’s assumptions involved (a) comparing significant assumptions (including management’s PTRS, peak year sales assumptions and sales erosion curves) to historical market data, benchmarking and other external data (where appropriate); and (b) performing a retrospective comparison of forecasted revenues to actual past performance for launched products. Professionals with specialised skill and knowledge were used to assist in the evaluation of the methodology and valuation techniques used and certain significant assumptions (including PTRS).
/s/ PricewaterhouseCoopers LLP
10 February 2022
We have served as the Company’s auditor since 2017.
F-6
Consolidated Statement of Comprehensive Income
for the year ended 31 December
|
| 2021 |
| 2020 |
| 2019 |
| |||||
Notes | $m | $m | $m |
| ||||||||
Product Sales | 1 | | | | ||||||||
Collaboration Revenue | 1 | | | | ||||||||
Total Revenue | | | | |||||||||
Cost of sales | ( | ( | ( | |||||||||
Gross profit | | | | |||||||||
Distribution costs | ( | ( | ( | |||||||||
Research and development expense | 2 | ( | ( | ( | ||||||||
Selling, general and administrative expense | 2 | ( | ( | ( | ||||||||
Other operating income and expense | 2 | | | | ||||||||
Operating profit | | | | |||||||||
Finance income | 3 | | | | ||||||||
Finance expense | 3 | ( | ( | ( | ||||||||
Share of after tax losses in associates and joint ventures | 11 | ( | ( | ( | ||||||||
(Loss)/profit before tax | ( | | | |||||||||
Taxation | 4 | | ( | ( | ||||||||
Profit for the period | | | | |||||||||
Other comprehensive income: | ||||||||||||
Items that will not be reclassified to profit or loss: | ||||||||||||
Remeasurement of the defined benefit pension liability | 22 | | ( | ( | ||||||||
Net (losses)/gains on equity investments measured at fair value through other comprehensive income | ( | | ( | |||||||||
Fair value movements related to own credit risk on bonds designated as fair value through profit and loss | – | ( | ( | |||||||||
Tax on items that will not be reclassified to profit or loss | 4 | | ( | | ||||||||
| | ( | ||||||||||
Items that may be reclassified subsequently to profit or loss: | ||||||||||||
Foreign exchange arising on consolidation | 23 | ( | | | ||||||||
Foreign exchange arising on designated borrowings in net investment hedges | 23 | ( | | ( | ||||||||
Fair value movements on cash flow hedges | ( | | ( | |||||||||
Fair value movements on cash flow hedges transferred to profit and loss | | ( | | |||||||||
Fair value movements on derivatives designated in net investment hedges | 23 | | | | ||||||||
(Costs)/gains of hedging | ( | | ( | |||||||||
Tax on items that may be reclassified subsequently to profit or loss | 4 | | ( | | ||||||||
( | | ( | ||||||||||
Other comprehensive (loss)/income for the period, net of tax | ( | | ( | |||||||||
Total comprehensive (loss)/income for the period | ( | | | |||||||||
Profit attributable to: | ||||||||||||
Owners of the Parent | | | | |||||||||
Non-controlling interests | 26 | | ( | ( | ||||||||
Total comprehensive (loss)/income attributable to: | ||||||||||||
Owners of the Parent | ( | | | |||||||||
Non-controlling interests | 26 | | ( | ( | ||||||||
Basic earnings per $ | 5 | $ | $ | $ | ||||||||
Diluted earnings per $ | 5 | $ | $ | $ | ||||||||
Weighted average number of Ordinary Shares in issue (millions) | 5 | | | | ||||||||
Diluted weighted average number of Ordinary Shares in issue (millions) | 5 | | | | ||||||||
Dividends declared and paid in the period | 25 | | | |
All activities were in respect of continuing operations.
$m means millions of US dollars.
F-7
Consolidated Statement of Financial Position
at 31 December
|
| 2021 | 2020 | 2019 |
| ||||
Notes | $m | $m | $m |
| |||||
Assets | |||||||||
Non-current assets | |||||||||
Property, plant and equipment | 7 | | | | |||||
Right-of-use assets | 8 | | | | |||||
Goodwill | 9 | | | | |||||
Intangible assets | 10 | | | | |||||
Investments in associates and joint ventures | 11 | | | | |||||
Other investments | 12 | | | | |||||
Derivative financial instruments | 13 | | | | |||||
Other receivables | 14 | | | | |||||
Deferred tax assets | 4 | | | | |||||
| | | |||||||
Current assets | |||||||||
Inventories | 15 | | | | |||||
Trade and other receivables | 16 | | | | |||||
Other investments | 12 | | | | |||||
Derivative financial instruments | 13 | | | | |||||
Intangible assets | 10 | | – | – | |||||
Income tax receivable | | | | ||||||
Cash and cash equivalents | 17 | | | | |||||
Assets held for sale | 18 | | – | | |||||
| | | |||||||
Total assets | | | | ||||||
Liabilities | |||||||||
Current liabilities | |||||||||
Interest-bearing loans and borrowings | 19 | ( | ( | ( | |||||
Lease liabilities | 8 | ( | ( | ( | |||||
Trade and other payables | 20 | ( | ( | ( | |||||
Derivative financial instruments | 13 | ( | ( | ( | |||||
Provisions | 21 | ( | ( | ( | |||||
Income tax payable | ( | ( | ( | ||||||
( | ( | ( | |||||||
Non-current liabilities | |||||||||
Interest-bearing loans and borrowings | 19 | ( | ( | ( | |||||
Lease liabilities | 8 | ( | ( | ( | |||||
Derivative financial instruments | 13 | ( | ( | ( | |||||
Deferred tax liabilities | 4 | ( | ( | ( | |||||
Retirement benefit obligations | 22 | ( | ( | ( | |||||
Provisions | 21 | ( | ( | ( | |||||
Other payables | 20 | ( | ( | ( | |||||
( | ( | ( | |||||||
Total liabilities | ( | ( | ( | ||||||
Net assets | | | | ||||||
Equity | |||||||||
Capital and reserves attributable to equity holders of the Company | |||||||||
Share capital | 24 | | | | |||||
Share premium account | | | | ||||||
Capital redemption reserve | | | | ||||||
Merger reserve | | | | ||||||
Other reserves | 23 | | | | |||||
Retained earnings | 23 | | | | |||||
| | | |||||||
Non-controlling interests | 26 | | | | |||||
Total equity | | | |
The Financial Statements from pages 134 to 201 were approved by the Board and were signed on its behalf by
Pascal Soriot | Aradhana Sarin |
Director | Director |
10 February 2022 |
F-8
Consolidated Statement of Changes in Equity
for the year ended 31 December
|
| Share |
| Capital |
|
|
|
| Total |
| Non- |
|
| ||||||
Share | premium | redemption | Merger | Other | Retained | attributable | controlling | Total |
| ||||||||||
capital | account | reserve | reserve | reserves | earnings | to owners | interests | equity |
| ||||||||||
$m | $m | $m | $m | $m | $m | $m | $m | $m |
| ||||||||||
At 1 January 2019 |
| | | | | | | | | | |||||||||
Adoption of new accounting standards1 |
| – | – | – | – | – | | | – | | |||||||||
Profit for the period | – | – | – | – | – | | | ( | | ||||||||||
Other comprehensive loss2 |
| – | – | – | – | – | ( | ( | | ( | |||||||||
Transfer to other reserves3 |
| – | – | – | – | | ( | – | – | – | |||||||||
Transactions with owners |
| ||||||||||||||||||
Dividends |
| – | – | – | – | – | ( | ( | – | ( | |||||||||
Issue of Ordinary Shares |
| | | – | – | – | – | | – | | |||||||||
Share-based payments charge for the period (Note 29) |
| – | – | – | – | – | | | – | | |||||||||
Settlement of share plan awards | – | – | – | – | – | ( | ( | – | ( | ||||||||||
Net movement |
| | | – | – | | ( | | ( | | |||||||||
At 31 December 2019 |
| | | | | | | | | | |||||||||
Profit for the period |
| – | – | – | – | – | | | ( | | |||||||||
Other comprehensive income2 |
| – | – | – | – | – | | | – | | |||||||||
Transfer to other reserves3, 4 |
| – | – | – | – | ( | | | ( | – | |||||||||
Transactions with owners |
| ||||||||||||||||||
Dividends |
| – | – | – | – | – | ( | ( | – | ( | |||||||||
Issue of Ordinary Shares |
| – | | – | – | – | – | | – | | |||||||||
Share-based payments charge for the period (Note 29) |
| – | – | – | – | – | | | – | | |||||||||
Settlement of share plan awards | – | – | – | – | – | ( | ( | – | ( | ||||||||||
Net movement |
| – | | – | – | ( | | | ( | | |||||||||
At 31 December 2020 |
| | | | | | | | | | |||||||||
Profit for the period |
| – | – | – | – | – | | | | | |||||||||
Other comprehensive loss2 |
| – | – | – | – | – | ( | ( | – | ( | |||||||||
Transfer to other reserves3 |
| – | – | – | – | | ( | – | – | – | |||||||||
Transactions with owners |
| ||||||||||||||||||
Dividends |
| – | – | – | – | – | ( | ( | – | ( | |||||||||
Issue of Ordinary Shares |
| | | – | – | – | – | | – | | |||||||||
Share-based payments charge for the period (Note 29) |
| – | – | – | – | – | | | – | | |||||||||
Settlement of share plan awards | – | – | – | – | – | ( | ( | – | ( | ||||||||||
Issue of replacement Alexion share awards upon acquisition (Note 27)5 | – | – | – | – | – | | | – | | ||||||||||
Net movement6 |
| | | – | – | | ( | | | | |||||||||
At 31 December 2021 |
| | | | | | | | | |
| 1. |
| 2. |
| 3. |
| 4. |
| 5. |
| 6. |
F-9
Consolidated Statement of Cash Flows
for the year ended 31 December
|
| 2021 |
| 2020 |
| 2019 |
| ||
Notes | $m | $m | $m |
| |||||
Cash flows from operating activities | |||||||||
(Loss)/profit before tax | ( | | | ||||||
Finance income and expense | 3 | | | | |||||
Share of after tax losses of associates and joint ventures | 11 | | | | |||||
Depreciation, amortisation and impairment | | | | ||||||
Increase in trade and other receivables | ( | ( | ( | ||||||
Decrease/(increase) in inventories | | ( | ( | ||||||
Increase in trade and other payables and provisions | | | | ||||||
Gains on disposal of intangible assets | 2 | ( | ( | ( | |||||
Gains on disposal of investment in associates and joint ventures | 2 | ( | – | – | |||||
Fair value movements on contingent consideration arising from business combinations | 20 | | ( | ( | |||||
Non-cash and other movements | 17 | | ( | | |||||
Cash generated from operations | | | | ||||||
Interest paid | ( | ( | ( | ||||||
Tax paid | ( | ( | ( | ||||||
Net cash inflow from operating activities | | | | ||||||
Cash flows from investing activities | |||||||||
Acquisition of subsidiaries, net of cash acquired | 27 | ( | – | – | |||||
Payments upon vesting of employee share awards attributable to business combinations | ( | – | – | ||||||
Payment of contingent consideration from business combinations | 20 | ( | ( | ( | |||||
Purchase of property, plant and equipment | ( | ( | ( | ||||||
Disposal of property, plant and equipment | | | | ||||||
Purchase of intangible assets | ( | ( | ( | ||||||
Disposal of intangible assets | | | | ||||||
Movement in profit-participation liability | 2 | | | | |||||
Purchase of non-current asset investments | ( | ( | ( | ||||||
Disposal of non-current asset investments | | | | ||||||
Movement in short-term investments, fixed deposits and other investing instruments | | | | ||||||
Payments to associates and joint ventures | 11 | ( | ( | ( | |||||
Disposal of investments in associates and joint ventures | | – | – | ||||||
Interest received | | | | ||||||
Net cash outflow from investing activities | ( | ( | ( | ||||||
Net cash (outflow)/inflow before financing activities | ( | | | ||||||
Cash flows from financing activities | |||||||||
Proceeds from issue of share capital | | | | ||||||
Issue of loans and borrowings | | | | ||||||
Repayment of loans and borrowings | ( | ( | ( | ||||||
Dividends paid | ( | ( | ( | ||||||
Hedge contracts relating to dividend payments | ( | ( | | ||||||
Repayment of obligations under leases | ( | ( | ( | ||||||
Movement in short-term borrowings | ( | | ( | ||||||
Payments to acquire non-controlling interests | ( | – | – | ||||||
Net cash inflow/(outflow) from financing activities | | ( | ( | ||||||
Net (decrease)/increase in Cash and cash equivalents in the period | ( | | | ||||||
Cash and cash equivalents at the beginning of the period | | | | ||||||
Exchange rate effects | ( | | | ||||||
Cash and cash equivalents at the end of the period | 17 | | | |
F-10
Group Accounting Policies
Basis of accounting and preparation of financial information
The Consolidated Financial Statements have been prepared under the historical cost convention, modified to include revaluation to fair value of certain financial instruments as described below, in accordance with UK-adopted International Accounting Standards and with the requirements of the Companies Act 2006 as applicable to companies reporting under those standards. The Consolidated Financial Statements also comply fully with International Financial Reporting Standards (IFRSs) as issued by the International Accounting Standards Board (IASB) and International Accounting Standards as adopted by the European Union.
The Consolidated Financial Statements are presented in US dollars, which is the Company’s functional currency.
In preparing their individual financial statements, the accounting policies of some overseas subsidiaries do not conform with IASB issued IFRSs. Therefore, where appropriate, adjustments are made in order to present the Consolidated Financial Statements on a consistent basis.
UK-adopted International Accounting Standards
On 31 December 2020, EU-adopted IFRS was brought into UK law and became UK-adopted International Accounting Standards, with future changes to IFRS being subject to endorsement by the UK Endorsement Board. The Consolidated Financial Statements transitioned to UK-adopted International Accounting Standards for financial periods beginning 1 January 2021. This change constitutes a change in accounting framework. However, there is no impact on recognition, measurement or disclosure in the period reported as a result of the change in framework.
IFRS 9, IFRS 7
The replacement of benchmark interest rates such as LIBOR and other interbank offered rates (IBORs) is a priority for global regulators. Phase 2 amendments to IFRS 9 ‘Financial Instruments’ and IFRS 7 ‘Financial Instruments: Disclosures’ were issued in August 2021 and have been adopted by the Group for 2021 reporting. As at 31 December 2021, the Group held instruments totalling $
Basis for preparation of Financial Statements on a going concern basis
The Group has considerable financial resources available. As at 31 December 2021, the Group has $
The Directors have considered the impact of COVID-19 on AstraZeneca’s operations and mitigations to these risks. Overall, the impact of these items would heighten certain risks, such as those relating to the delivery of the pipeline or launch of new medicines, the execution of AstraZeneca’s commercial strategy, the manufacturing and supply of medicines and reliance on third-party goods and services. The Group is continuously monitoring, and mitigating where possible, impacts of these risks.
The Group’s revenues are largely derived from sales of medicines covered by patents, which provide a relatively high level of resilience and predictability to cash inflows, although government price interventions in response to budgetary constraints are expected to continue to adversely affect revenues in some of our significant markets. The Group, however, anticipates new revenue streams from both recently launched medicines and those in development, and the Group has a wide diversity of customers and suppliers across different geographic areas.
Consequently, the Directors believe that, overall, the Group is well placed to manage its business risks successfully. Accordingly, they continue to adopt the going concern basis in preparing the Annual Report and Financial Statements.
Estimates and judgements
The preparation of the Financial Statements in conformity with generally accepted accounting principles requires management to make estimates and judgements that affect the reported amounts of assets and liabilities at the date of the Financial Statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
The accounting policy descriptions set out the areas where judgements and estimates need exercising, the most significant of which include the following Key Judgements and Significant Estimates:
| > | revenue recognition – see Revenue Accounting Policy on page 139 and Note 1 on page 145 |
| > | expensing of internal development expenses – see Research and Development Policy on page 140 |
| > | impairment reviews of Intangible assets – see Note 10 on page 156 |
| > | useful economic life of Intangible assets – see Research and Development Policy on page 140 and Note 10 on page 156 |
| > | business combinations and Goodwill (and Contingent consideration arising from business combinations) – see Business Combinations and Goodwill Policy on page 142, Note 10 on page 156, Note 20 on page 166 and Note 27 on page 178 |
| > | litigation liabilities – see Litigation and Environmental Liabilities within Note 30 on page 189 |
| > | operating segments – see Note 6 on page 152 |
| > | employee benefits – see Note 22 on page 168 |
| > | taxation – see Taxation Policy on page 141 and Note 30 on page 189. |
AstraZeneca has assessed the impact of the uncertainty presented by the COVID-19 pandemic on the Financial Statements, specifically considering the impact on key judgements and significant estimates along with several other areas of increased risk.
A detailed assessment has been performed, focusing on the following areas:
| > | recoverable value of goodwill, intangible assets and property, plant and equipment |
| > | impact on key assumptions used to estimate contingent consideration liabilities |
| > | key assumptions used in estimating the Group’s defined benefit pension obligations |
| > | basis for estimating clinical trial accruals |
| > | key assumptions used in estimating rebates and chargebacks for US Product Sales |
| > | valuations of unlisted equity investments |
| > | expected credit losses associated with changes in credit risk relating to trade and other receivables |
| > | net realisable value of inventories |
| > | fair value of certain financial instruments |
| > | recoverability of deferred tax assets |
F-11
| > | effectiveness of hedge relationships. |
No material accounting impacts relating to the areas assessed above were recognised in the year.
The Group will continue to monitor these areas of increased judgement, estimation and risk for material changes.
The Group has assessed the impact of climate risk on its financial reporting. The impact assessment was primarily focused on the valuation and useful lives of intangible assets and the identification and valuation of provisions and contingent liabilities, as these are judged to be the key areas that could be impacted by climate risks. No material accounting impacts or changes to judgements or other required disclosures were noted.
Financial risk management policies are detailed in Note 28 to the Financial Statements from page 180.
AstraZeneca’s management considers the following to be the most important accounting policies in the context of the Group’s operations.
Revenue
Revenue comprises Product Sales and Collaboration Revenue.
Product Sales are revenues arising from contracts with customers. Collaboration Revenue arises from other contracts, however, the recognition and measurement principles of IFRS 15 ‘Revenue from Contracts with Customers’ are applied as set out below.
Revenue excludes inter-company revenues and value-added taxes.
Product Sales
Product Sales represent net invoice value less estimated rebates, returns and chargebacks, which are considered to be variable consideration and include significant estimates. Sales are recognised when the control of the goods has been transferred to a third party. This is usually when title passes to the customer, either on shipment or on receipt of goods by the customer, depending on local trading terms. In markets where returns are significant, estimates of returns are accounted for at the point revenue is recognised. Revenue is not recognised in full until it is highly probable that a significant reversal in the amount of cumulative revenue recognised will not occur.
Rebates are amounts payable or credited to a customer, usually based on the quantity or value of Product Sales to the customer for specific products in a certain period. Product sales rebates, which relate to Product Sales that occur over a period of time, are normally issued retrospectively.
At the time Product Sales are invoiced, rebates and deductions that the Group expects to pay, are estimated. These rebates typically arise from sales contracts with government payers, third-party managed care organisations, hospitals, long-term care facilities, group purchasing organisations and various state programmes.
For the markets where returns are significant, we estimate the quantity and value of goods which may ultimately be returned at the point of sale. Our returns accruals are based on actual experience over the preceding
When a product faces generic competition, particular attention is given to the possible levels of returns and, in cases where the circumstances are such that the level of Product Sales are considered highly probable to reverse, revenues are only recognised when the right of return expires, which is generally on ultimate prescription of the product to patients.
The methodology and assumptions used to estimate rebates and returns are monitored and adjusted regularly in the light of contractual and legal obligations, historical trends, past experience and projected market conditions. Once the uncertainty associated with returns is resolved, revenue is adjusted accordingly.
Under certain collaboration agreements which include a profit sharing mechanism, our recognition of Product Sales depends on which party acts as principal in sales to the end customer. In the cases where AstraZeneca acts as principal, we record
Contracts relating to the supply of Vaxzevria during the COVID-19 pandemic include conditions whereby payments are receivable from customers in advance of the delivery of product. Such amounts are held on the balance sheet as contract liabilities until the related revenue is recognised, generally upon product delivery. Certain of these contracts contain further provisions that restrict the use of inventory manufactured in specified supply chains to specified customers, resulting in an enforceable right to payment as the activities are performed. Under IFRS 15, such contracts require revenue to be recognised over time using an appropriate and reasonably measurable method to measure progress. Revenue is recognised on these contracts based on the proportion of product delivered compared to the total contracted volumes.
Collaboration Revenue
Collaboration Revenue includes income from collaborative arrangements where either the Group has sold certain rights associated with those products, but retains a significant ongoing economic interest or has acquired a significant interest from a third party. Significant interest can include ongoing supply of finished goods, participation in sharing of profit arrangements or direct interest from sales of medicines.
These arrangements may include development arrangements, commercialisation arrangements and collaborations. Income may take the form of upfront fees, milestones, profit sharing and royalties and includes sharing of profit arising from sales made as principal by a collaboration partner.
Timing of recognition of clinical and regulatory milestones is considered to be a key judgement. There can be significant uncertainty over whether it is highly probable that there would not be a significant reversal of revenue in respect of specific milestones if these are recognised before they are triggered due to them being subject to the actions of third parties. In general, where the triggering of a milestone is subject to the decisions of third parties (e.g. the acceptance or approval of a filing by a regulatory authority), the Group does not consider that the threshold for recognition is met until that decision is made.
Where Collaboration Revenue arises from the licensing of the Group’s own intellectual property, the licences we grant are typically rights to use intellectual property which do not change during the period of the licence and therefore related non-conditional revenue is recognised at the point the license is granted and variable consideration as soon as recognition criteria are met. Those licences are generally unique and therefore when there are other performance obligations in the contract, the basis of allocation of the consideration makes use of the residual approach as permitted by IFRS 15.
These arrangements typically involve the receipt of an upfront payment, which the contract attributes to the license of the intangible assets, and ongoing receipts, which the contract attributes to the sale of the product we manufacture. In cases where the transaction has two or more components, we account for the delivered item (for example, the transfer of title to the intangible asset) as a separate unit of accounting and record revenue on delivery of that component, provided that we can make a reasonable estimate of the fair value of the undelivered component.
F-12
Where non-contingent amounts are payable over one year from the effective date of a contract, an assessment is made as to whether a significant financing component exists, and if so, the fair value of this component is deferred and recognised over the period to the expected date of receipt.
Where control of a right to use an intangible asset passes at the outset of an arrangement, revenue is recognised at the point in time control is transferred. Where the substance of an arrangement is that of a right to access rights attributable to an intangible asset, revenue is recognised over time, normally on a straight-line basis over the life of the contract.
Where the fair market value of the undelivered component (for example, a manufacturing agreement) exceeds the contracted price for that component, we defer an appropriate element of the upfront consideration and amortise this over the performance period. However, where the fair market value of the undelivered component is equal to or lower than the contracted price for that component, we treat the whole of the upfront amount as being attributable to the delivered intangible assets and recognise that part of the revenue upon delivery. No element of the contracted revenue related to the undelivered component is ordinarily allocated to the sale of the intangible asset. This is because the contracted revenue relating to the undelivered component is contingent on future events (such as sales) and cannot be recognised until either receipt of the amount is highly probable or where the consideration is received for a licence of intellectual property, on the occurrence of the related sales.
Where the Group provides ongoing services, revenue in respect of this element is recognised over the duration of those services. Where the arrangement meets the definition of a licence agreement, sales milestones and sales royalties are recognised when achieved by applying the royalty exemption under IFRS 15. All other milestones and sales royalties are recognised when considered it is highly probable there will not be a significant reversal of cumulative income. The determination requires estimates to be made in relation to future Product Sales.
Where Collaboration Revenue is recorded and there is a related Intangible asset that is licensed as part of the arrangement, an appropriate amount of that Intangible asset is charged to Cost of sales based on an allocation of cost or value to the rights that have been licenced.
Cost of sales
Cost of sales are recognised as the associated revenue is recognised. Cost of sales include manufacturing costs, royalties payable on revenues recognised, movements in provisions for inventories, inventory write-offs and impairment charges in relation to manufacturing assets. Cost of sales also includes co-collaborator sharing of profit arising from collaborations, and foreign exchange gains and losses arising from business trading activities.
Research and development
Research expenditure is charged to profit and loss in the year in which it is incurred.
Internal development expenditure is capitalised only if it meets the recognition criteria of IAS 38 ‘Intangible Assets’. This is considered a key judgement. Where regulatory and other uncertainties are such that the criteria are not met, the expenditure is charged to profit and loss and this is almost invariably the case prior to approval of the drug by the relevant regulatory authority. Where, however, recognition criteria are met, Intangible assets are capitalised and amortised on a straight-line basis over their useful economic lives from product launch. At 31 December 2021,
Payments to in-license products and compounds from third parties for new research and development projects (in process research and development) generally take the form of upfront payments, milestones and royalty payments. Where payments made to third parties represent consideration for future research and development activities, an evaluation is made as to the nature of the payments. Such payments are expensed if they represent compensation for sub-contracted research and development services not resulting in a transfer of intellectual property. By contrast, payments are capitalised if they represent compensation for the transfer of identifiable intellectual property developed at the risk of the third party. Development milestone payments relating to identifiable intellectual property are capitalised as the milestone is triggered. Any upfront or milestone payments for research activities where there is no associated identifiable intellectual property are expensed. Assets capitalised are amortised, on a straight-line basis, over their useful economic lives from product launch.
The determination of useful economic life is considered to be a key judgement. On product launch, the Group makes a judgement as to the expected useful economic life with reference to the expiry of associated patents for the product, expectation around the competitive environment specific to the product and our detailed long-term risk-adjusted sales projections compiled annually across the Group and approved by the Board.
The useful economic life can extend beyond patent expiry dependent upon the nature of the product and the complexity of the development and manufacturing process. Significant sales can often be achieved post patent expiration.
Intangible assets
Intangible assets are stated at cost less amortisation and impairments. Intangible assets relating to products in development are subject to impairment testing annually. All Intangible assets are tested for impairment when there are indications that the carrying value may not be recoverable. The determination of the recoverable amounts include key estimates which are highly sensitive to, and depend upon, key assumptions as detailed in Note 10 to the Financial Statements from page 156.
Impairment reviews have been carried out on all Intangible assets that are in development (and not being amortised), all major intangible assets acquired during the year and all other intangible assets that have had indications of impairment during the year. Recoverable amount is determined as the higher of value in use or fair value less costs to sell using a discounted cash flow calculation, where the products’ expected cash flows are risk-adjusted over their estimated remaining useful economic life. The determination of the recoverable amounts include significant estimates which are highly sensitive and depend upon key assumptions as detailed in Note 10 to the Financial Statements from page 156. Sales forecasts and specific allocated costs (which have both been subject to appropriate senior management review and approval) are risk-adjusted and discounted using appropriate rates based on our post-tax weighted average cost of capital or for fair value less costs to sell, a required rate of return for a market participant. Our weighted average cost of capital reflects factors such as our capital structure and our costs of debt and equity.
Any impairment losses are recognised immediately in profit. Intangible assets relating to products which fail during development (or for which development ceases for other reasons) are also tested for impairment and are written down to their recoverable amount (which is usually nil).
If, subsequent to an impairment loss being recognised, development restarts or other facts and circumstances change indicating that the impairment is less or no longer exists, the value of the asset is re-estimated and its carrying value is increased to the recoverable amount, but not exceeding the original value, by recognising an impairment reversal in Operating profit.
Government grants
Government grants are recognised in the Consolidated Statement of Comprehensive Income so as to match with the related expenses that they are intended to compensate. Where grants are received in advance of the related expenses, they are initially recognised in the Consolidated Statement of Financial Position under Trade and other payables as deferred income and released to net off against the related expenditure when incurred.
F-13
Each contract is assessed to determine whether there are both grant elements and supply of product which need to be separated. In each case, the contracts set out the specified terms for the supply of the product and the provisions for funding for certain costs, primarily research and development associated with the IP. It is considered whether there are any conditions for the funding to be refunded. The consideration in the contract is allocated between the grant and supply elements. The standalone selling price for the supply of products is determined by reference to observed prices with other customers. The amount allocated as a government grant is determined by reference to the specific agreed costs and activities identified in the contract as not directly attributable to the supply of product. Government grants are recorded as an offset to the relevant expense in the Consolidated Statement of Comprehensive Income and are capped to match the relevant costs incurred.
Joint arrangements and associates
The Group has arrangements over which it has joint control and which qualify as joint operations or joint ventures under IFRS 11 ‘Joint Arrangements’. For joint operations, the Group recognises its share of revenue that it earns from the joint operations and its share of expenses incurred. The Group also recognises the assets associated with the joint operations that it controls and the liabilities it incurs under the joint arrangement. For joint ventures and associates, the Group recognises its interest in the joint venture or associate as an investment and uses the equity method of accounting.
Employee benefits
The Group accounts for pensions and other employee benefits (principally healthcare) under IAS 19 ‘Employee Benefits’ and recognises all actuarial gains and losses immediately through Other comprehensive income. In respect of defined benefit plans, obligations are measured at discounted present value while plan assets are measured at fair value. Given the extent of the assumptions used to determine these values, these are considered to be significant estimates. The operating and financing costs of such plans are recognised separately in profit, current service costs are spread systematically over the lives of employees and financing costs are recognised in full in the periods in which they arise. Remeasurements of the net defined benefit pension liability, including actuarial gains and losses, are recognised immediately in Other comprehensive income.
Where the calculation results in a surplus to the Group, the recognised asset is limited to the present value of any available future refunds from the plan or reductions in future contributions to the plan. Payments to defined contribution plans are recognised in profit as they fall due.
Taxation
The current tax payable is based on taxable profit for the year. Taxable profit differs from reported profit because taxable profit excludes items that are either never taxable or tax deductible or items that are taxable or tax deductible in a different period. The Group's current tax assets and liabilities are calculated using tax rates that have been enacted or substantively enacted by the reporting date.
Deferred tax is provided using the balance sheet liability method, providing for temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for taxation purposes. Deferred tax assets are recognised to the extent that it is probable that future taxable profit will be available against which the asset can be utilised. This requires judgements to be made in respect of the availability of future taxable income.
No deferred tax asset or liability is recognised in respect of temporary differences associated with investments in subsidiaries and branches where the Group is able to control the timing of reversal of the temporary differences and it is probable that the temporary differences will not reverse in the foreseeable future.
The Group's Deferred tax assets and liabilities are calculated using tax rates that are expected to apply in the period when the liability is settled or the asset realised based on tax rates that have been enacted or substantively enacted by the reporting date.
Accruals for tax contingencies require management to make judgements of potential exposures in relation to tax audit issues. Tax benefits are not recognised unless the tax positions will probably be accepted by the tax authorities. This is based upon management's interpretation of applicable laws and regulations and the expectation of how the tax authority will resolve the matter. Once considered probable of not being accepted, management reviews each material tax benefit and reflects the effect of the uncertainty in determining the related taxable result.
Accruals for tax contingencies are measured using either the most likely amount or the expected value amount depending on which method the entity expects to better predict the resolution of the uncertainty.
Further details of the estimates and assumptions made in determining our recorded liability for transfer pricing contingencies and other tax contingencies are included in Note 30 to the Financial Statements from page 189.
Share-based payments
All plans have been classified as equity settled after assessment. The grant date fair value of employee share plan awards is calculated using a Monte Carlo model. In accordance with IFRS 2 ‘Share-based Payment’, the resulting cost is recognised in profit over the vesting period of the awards, being the period in which the services are received. The value of the charge is adjusted to reflect expected and actual levels of awards vesting, except where the failure to vest is as a result of not meeting a market condition. Cancellations of equity instruments are treated as an acceleration of the vesting period and any outstanding charge is recognised in profit immediately.
Cash outflows relating to the vesting of share plans for our employees are recognised within operating activities, as they relate to employee remuneration. The cash flows relating to replacement awards issued to employees as part of the Alexion acquisition (see Note 27 from page 178) are classified within investing activities, as they are part of the aggregate cash flows arising from obtaining control of the subsidiary.
Property, plant and equipment
The Group’s policy is to write off the difference between the cost of each item of Property, plant and equipment and its residual value over its estimated useful life on a straight-line basis. Assets under construction are not depreciated.
Reviews are made annually of the estimated remaining lives and residual values of individual productive assets, taking account of commercial and technological obsolescence as well as normal wear and tear. It is impractical to calculate average asset lives exactly. However, the total lives range from approximately
Borrowing costs
The Group has no borrowing costs with respect to the acquisition or construction of qualifying assets. All other borrowing costs are recognised in profit as incurred and in accordance with the effective interest rate method.
Leases
The Group’s lease arrangements are principally for property, most notably a portfolio of office premises and employee accommodation, and for a global car fleet, utilised primarily by our sales and marketing teams.
F-14
The lease liability and corresponding right-of-use asset arising from a lease are initially measured on a present value basis. Lease liabilities include the net present value of the following lease payments:
| > | fixed payments, less any lease incentives receivable |
| > | variable lease payments that depend on an index or a rate, initially measured using the index or rate as at the commencement date |
| > | the exercise price of a purchase option if the Group is reasonably certain to exercise that option |
| > | payments of penalties for terminating the lease, if the lease term reflects the Group exercising that option, and |
| > | amounts expected to be payable by the Group under residual value guarantees. |
Right-of-use assets are measured at cost comprising the following:
| > | the amount of the initial measurement of lease liability |
| > | any lease payments made at or before the commencement date less any lease incentives received |
| > | any initial direct costs, and |
| > | restoration costs. |
Judgements made in calculating the lease liability include assessing whether arrangements contain a lease and determining the lease term. Lease terms are negotiated on an individual basis and contain a wide range of different terms and conditions. Property leases will often include an early termination or extension option to the lease term. Fleet management policies vary by jurisdiction and may include renewal of a lease until a measurement threshold, such as mileage, is reached. Extension and termination options have been considered when determining the lease term, along with all facts and circumstances that may create an economic incentive to exercise an extension option, or not exercise a termination option. Extension periods (or periods after termination options) are only included in the lease term if the lease is reasonably certain to be extended (or not terminated).
The lease payments are discounted using incremental borrowing rates, as in the majority of leases held by the Group the interest rate implicit in the lease is not readily identifiable. Calculating the discount rate is an estimate made in calculating the lease liability. This rate is the rate that the Group would have to pay to borrow the funds necessary to obtain an asset of similar value to the right-of-use asset in a similar economic environment with similar terms, security and conditions. To determine the incremental borrowing rate, the Group uses a risk-free interest rate adjusted for credit risk, adjusting for terms specific to the lease including term, country and currency.
The Group is exposed to potential future increases in variable lease payments that are based on an index or rate, which are initially measured as at the commencement date, with any future changes in the index or rate excluded from the lease liability until they take effect. When adjustments to lease payments based on an index or rate take effect, the lease liability is reassessed and adjusted against the right-of-use asset.
Lease payments are allocated between principal and finance cost. The finance cost is charged to the Consolidated Statement of Comprehensive Income over the lease period so as to produce a constant periodic rate of interest on the remaining balance of the liability for each period.
Payments associated with short-term leases of Property, plant and equipment and all leases of low-value assets are recognised on a straight-line basis as an expense in the Consolidated Statement of Comprehensive Income. Short-term leases are leases with a lease term of 12 months or less. Low-value leases are those where the underlying asset value, when new, is $
Contracts may contain both lease and non-lease components. The Group allocates the consideration in the contract to the lease and non-lease components based on their relative standalone prices.
Right-of-use assets are generally depreciated over the shorter of the asset's useful life and the lease term on a straight-line basis. If the Group is reasonably certain to exercise a purchase option, the right-of-use asset is depreciated over the underlying asset’s useful life. It is impractical to calculate average asset lives exactly. However, the total lives range from approximately
There are no material lease agreements under which the Group is a lessor.
Business combinations and goodwill
In assessing whether an acquired set of assets and activities is a business or an asset, management will first elect whether to apply an optional concentration test to simplify the assessment. Where the concentration test is applied, the acquisition will be treated as the acquisition of an asset if substantially all of the fair value of the gross assets acquired (excluding cash and cash equivalents, deferred tax assets, and related goodwill) is concentrated in a single asset or group of similar identifiable assets.
Where the concentration test is not applied, or is not met, a further assessment of whether the acquired set of assets and activities is a business will be performed.
The determination of whether an acquired set of assets and activities is a business or an asset can be judgemental, particularly if the target is not producing outputs. Management uses a number of factors to make this determination, which are primarily focused on whether the acquired set of assets and activities include substantive processes that mean the set is capable of being managed for the purpose of providing a return. Key determining factors include the stage of development of any assets acquired, the readiness and ability of the acquired set to produce outputs and the presence of key experienced employees capable of conducting activities required to develop or manufacture the assets. Typically, the specialised nature of many pharmaceutical assets and processes is such that until assets are substantively ready for production and promotion, there are not the required processes for a set of assets and activities to meet the definition of a business in IFRS 3.
On the acquisition of a business, fair values are attributed to the identifiable assets and liabilities. Attributing fair values is a key judgement; refer to Note 27 to the Financial Statements on page 178 for additional details of the 2021 acquisition. Contingent liabilities are also recorded at fair value unless the fair value cannot be measured reliably, in which case the value is subsumed into goodwill. Where fair values of acquired contingent liabilities cannot be measured reliably, the assumed contingent liability is not recognised but is disclosed in the same manner as other contingent liabilities. Where the Group fully acquires, through a business combination, assets that were previously held in joint operations, the Group has elected not to uplift the book value of the existing interest in the asset held in the joint operation to fair value at the date full control is taken.
Where not all of the equity of a subsidiary is acquired, the non-controlling interest is recognised either at fair value or at the non-controlling interest’s proportionate share of the net assets of the subsidiary, on a case-by-case basis. Put options over non-controlling interests are recognised as a financial liability, with a corresponding entry in either Retained earnings or against non-controlling interest reserves on a case-by-case basis.
The timing and amount of future contingent elements of consideration is considered a significant estimate; see Note 20 from page 166. Contingent consideration, which may include development and launch milestones, revenue threshold milestones and revenue-based royalties, is fair valued at the date of acquisition using decision-tree analysis with key inputs including probability of success, consideration of potential delays and revenue
F-15
projections based on the Group’s internal forecasts. Unsettled amounts of consideration are held at fair value within payables with changes in fair value recognised immediately in profit.
Goodwill is the difference between the fair value of the consideration and the fair value of net assets acquired.
Goodwill arising on acquisitions is capitalised and subject to an impairment review, both annually and when there is an indication that the carrying value may not be recoverable.
The Group’s policy up to and including 1997 was to eliminate Goodwill arising upon acquisitions against reserves. Under IFRS 1 ‘First-time Adoption of International Financial Reporting Standards’ and IFRS 3 ‘Business Combinations’, such Goodwill will remain eliminated against reserves.
Subsidiaries
A subsidiary is an entity controlled, directly or indirectly, by AstraZeneca PLC. Control is regarded as the exposure or rights to the variable returns of the entity when combined with the power to affect those returns. Control is normally evidenced by holding more than 50% of the share capital of the company, however other agreements may be in place that result in control where they give AstraZeneca finance decision-making authority over the relevant activities of the company.
The financial results of subsidiaries are consolidated from the date control is obtained until the date that control ceases.
Inventories
Inventories are stated at the lower of cost and net realisable value. The first in, first out or an average method of valuation is used. For finished goods and work in progress, cost includes directly attributable costs and certain overhead expenses (including depreciation). Selling expenses and certain other overhead expenses (principally central administration costs) are excluded. Net realisable value is determined as estimated selling price less all estimated costs of completion and costs to be incurred in selling and distribution.
Write-downs of inventory occur in the general course of business and are recognised in Cost of sales for launched or approved products and in Research and development expense for products in development.
Assets held for sale
Non-current assets are classified as Assets held for sale when their carrying amount is to be recovered principally through a sale transaction and a sale is considered highly probable. A sale is usually considered highly probable only when the appropriate level of management has committed to the sale.
Assets held for sale are stated at the lower of carrying amount and fair value less costs to sell. Where there is a partial transfer of a non-current asset to held for sale, an allocation of value is made between the current and non-current portions of the asset based on the relative value of the two portions, unless there is a methodology that better reflects the asset to be disposed of.
Assets held for sale are not depreciated or amortised.
Trade and other receivables
Financial assets included in Trade and other receivables are recognised initially at fair value. The Group holds the Trade receivables with the objective to collect the contractual cash flows and therefore measures them subsequently at amortised cost using the effective interest rate method, less any impairment losses.
Trade receivables that are subject to debt factoring arrangements are derecognised if they meet the conditions for derecognition detailed in IFRS 9 ‘Financial Instruments’.
Trade and other payables
Financial liabilities included in Trade and other payables are recognised initially at fair value. Subsequent to initial recognition they are measured at amortised cost using the effective interest rate method. Contingent consideration payables are held at fair value within Level 3 of the fair value hierarchy as defined in Note 12.
Financial instruments
The Group’s financial instruments include Lease liabilities, Trade and other receivables and payables, liabilities for contingent consideration and put options under business combinations, and rights and obligations under employee benefit plans which are dealt with in specific accounting policies.
The Group’s other financial instruments include:
| > | Cash and cash equivalents |
| > | Fixed deposits |
| > | Other investments |
| > | Bank and other borrowings |
| > | Derivatives. |
Cash and cash equivalents
Cash and cash equivalents comprise cash in hand, current balances with banks and similar institutions, and highly liquid investments with maturities of three months or less when acquired. They are readily convertible into known amounts of cash and are held at amortised cost under the hold to collect classification, where they meet the hold to collect ‘solely payments of principal and interest’ test criteria under IFRS 9. Those not meeting these criteria are held at fair value through profit and loss. Cash and cash equivalents in the Consolidated Statement of Cash Flows include unsecured bank overdrafts at the balance sheet date where balances often fluctuate between a cash and overdraft position.
Fixed deposits
Fixed deposits, principally comprising funds held with banks and other financial institutions, are initially measured at fair value, plus direct transaction costs, and are subsequently measured at amortised cost using the effective interest rate method at each reporting date. Changes in carrying value are recognised in the Consolidated Statement of Comprehensive Income.
Other investments
Investments are classified as fair value through profit or loss (FVPL), unless the Group makes an irrevocable election at initial recognition for certain non-current equity investments to present changes in Other comprehensive income (FVOCI). If this election is made, there is no subsequent reclassification of fair value gains and losses to profit and loss following the derecognition of the investment.
F-16
Bank and other borrowings
The Group uses derivatives, principally interest rate swaps, to hedge the interest rate exposure inherent in a portion of its fixed interest rate debt. In such cases the Group will either designate the debt as fair value through profit and loss when certain criteria are met or as the hedged item under a fair value hedge.
If the debt instrument is designated as fair value through profit or loss, the debt is initially measured at fair value (with direct transaction costs being included in profit as an expense) and is remeasured to fair value at each reporting date with changes in carrying value being recognised in profit (along with changes in the fair value of the related derivative), with the exception of changes in the fair value of the debt instrument relating to own credit risk which are recorded in Other comprehensive income in accordance with IFRS 9. Such a designation has been made where this significantly reduces an accounting mismatch which would result from recognising gains and losses on different bases.
If the debt is designated as the hedged item under a fair value hedge, the debt is initially measured at fair value (with direct transaction costs being amortised over the life of the debt) and is remeasured for fair value changes in respect of the hedged risk at each reporting date with changes in carrying value being recognised in profit (along with changes in the fair value of the related derivative).
If the debt is designated in a cash flow hedge, the debt is measured at amortised cost (with gains or losses taken to profit and direct transaction costs being amortised over the life of the debt). The related derivative is remeasured for fair value changes at each reporting date with the portion of the gain or loss on the derivative that is determined to be an effective hedge recognised in Other comprehensive income. The amounts that have been recognised in Other comprehensive income are reclassified to profit in the same period that the hedged forecast cash flows affect profit. The reclassification adjustment is included in Finance expense in the Consolidated Statement of Comprehensive Income.
Other interest-bearing loans are initially measured at fair value (with direct transaction costs being amortised over the life of the loan) and are subsequently measured at amortised cost using the effective interest rate method at each reporting date. Changes in carrying value are recognised in the Consolidated Statement of Comprehensive Income.
Derivatives
Derivatives are initially measured at fair value (with direct transaction costs being included in profit as an expense) and are subsequently remeasured to fair value at each reporting date. Changes in carrying value are recognised in the Consolidated Statement of Comprehensive Income.
Foreign currencies
Foreign currency transactions, being transactions denominated in a currency other than an individual Group entity’s functional currency, are translated into the relevant functional currencies of individual Group entities at average rates for the relevant monthly accounting periods, which approximate to actual rates.
Monetary assets and liabilities arising from foreign currency transactions are retranslated at exchange rates prevailing at the reporting date. Exchange gains and losses on loans and on short-term foreign currency borrowings and deposits are included within Finance expense. Exchange differences on all other foreign currency transactions are recognised in Operating profit in the individual Group entity’s accounting records.
Non-monetary items arising from foreign currency transactions are not retranslated in the individual Group entity’s accounting records.
In the Consolidated Financial Statements, income and expense items for Group entities with a functional currency other than US dollars are translated into US dollars at average exchange rates, which approximate to actual rates, for the relevant accounting periods. Assets and liabilities are translated at the US dollar exchange rates prevailing at the reporting date. Exchange differences arising on consolidation are recognised in Other comprehensive income.
If certain criteria are met, non-US dollar denominated loans or derivatives are designated as net investment hedges of foreign operations. Exchange differences arising on retranslation of net investments, and of foreign currency loans which are designated in an effective net investment hedge relationship, are recognised in Other comprehensive income in the Consolidated Financial Statements. Foreign exchange derivatives hedging net investments in foreign operations are carried at fair value. Effective fair value movements are recognised in Other comprehensive income, with any ineffectiveness taken to profit. Gains and losses accumulated in the translation reserve will be recycled to profit and loss when the foreign operation is sold.
Litigation and environmental liabilities
AstraZeneca is involved in legal disputes, the settlement of which may involve cost to the Group. Provision is made where an adverse outcome is probable and associated costs, including related legal costs, can be estimated reliably. In other cases, appropriate disclosures are included. Determining the timing of recognition of when an adverse outcome is probable is considered a key judgement, refer to Note 30 to the Financial Statements on page 189.
Where it is considered that the Group is more likely than not to prevail, or in the rare circumstances where the amount of the legal liability cannot be estimated reliably, legal costs involved in defending the claim are charged to the Consolidated Statement of Comprehensive Income as they are incurred.
Where it is considered that the Group has a valid contract which provides the right to reimbursement (from insurance or otherwise) of legal costs and/or all or part of any loss incurred or for which a provision has been established, the best estimate of the amount expected to be received is recognised as an asset only when it is virtually certain.
AstraZeneca is exposed to environmental liabilities relating to its past operations, principally in respect of soil and groundwater remediation costs. Provisions for these costs are made when there is a present obligation and where it is probable that expenditure on remedial work will be required and a reliable estimate can be made of the cost. Provisions are discounted at the relevant risk free rate where the effect is material.
Impairment
The carrying values of non-financial assets, other than Inventories and Deferred tax assets, are reviewed at least annually to determine whether there is any indication of impairment. For Goodwill, Intangible assets under development and for any other assets where such indication exists, the asset’s recoverable amount is estimated based on the greater of its value in use and its fair value less cost to sell. In assessing the recoverable amount, the estimated future cash flows, adjusted for the risks specific to each asset, are discounted to their present value using a discount rate that reflects current market assessments of the time value of money, the general risks affecting the pharmaceutical industry and other risks specific to each asset. For the purpose of impairment testing, assets are grouped together into the smallest group of assets that generates cash inflows from continuing use that are largely independent of the cash flows of other assets. Impairment losses are recognised immediately in the Consolidated Statement of Comprehensive Income.
F-17
International accounting transition
On transition to using adopted IFRSs in the year ended 31 December 2005, the Group took advantage of several optional exemptions available in IFRS 1 ‘First-time Adoption of International Financial Reporting Standards’. The major impacts which are of continuing importance are detailed below:
| > | Business combinations – IFRS 3 ‘Business Combinations’ has been applied from 1 January 2003, the date of transition, rather than being applied fully retrospectively. As a result, the combination of Astra and Zeneca is still accounted for as a merger, rather than through purchase accounting. If purchase accounting had been adopted, Zeneca would have been deemed to have acquired Astra. |
| > | Cumulative exchange differences – the Group chose to set the cumulative exchange difference reserve at 1 January 2003 to |
Applicable accounting standards and interpretations issued but not yet adopted
At the date of authorisation of these financial statements, certain amendments were in issue relating to the following standards and interpretations but not yet adopted by the Group:
| > | amendments to IAS 12 'Income Taxes', IAS 8 'Accounting Policies, Changes in Accounting Estimates and Errors', IAS 1 'Presentation of Financial Statements' and IFRS Practice Statement 2 ‘Making materiality judgements’, effective for periods beginning on or after 1 January 2023 - not endorsed by the UK Endorsement Board (UKEB); |
| > | amendments to IAS 37 'Provisions, Contingent Liabilities and Contingent Assets', IAS 16 'Property, Plant and Equipment' and IFRS 3 'Business Combinations', effective for periods beginning on or after 1 January 2022 - not endorsed by the UKEB; |
| > | amendments to IAS 1 'Presentation of Financial Statements', effective for periods beginning on or after 1 January 2024 – not endorsed by the UKEB; and |
| > | amendments to IFRS 16 'Leases', effective for periods beginning on or after 1 April 2021 - endorsed by the UKEB on 12 May 2021. |
These amendments and interpretations are not expected to have a significant impact on the Group’s net results.
Notes to the Group Financial Statements
1 Revenue
Product Sales
F-18
| 2021 |
| 2020 |
| 2019 |
| |||||||||||||||||||||||||
Emerging | Rest of | Emerging | Rest of | Emerging | Rest of | ||||||||||||||||||||||||||
Markets | US | Europe | World | Total | Markets | US | Europe | World | Total | Markets | US | Europe | World | Total | |||||||||||||||||
$m | $m | $m | $m | $m | $m | $m | $m | $m | $m | $m | $m | $m | $m | $m |
| ||||||||||||||||
Oncology: |
|
|
|
|
|
| |||||||||||||||||||||||||
Tagrisso |
| | | | | |
| | | | | |
| | | | | | |||||||||||||
Imfinzi | | | | | | | | | | | | | | | | ||||||||||||||||
Lynparza |
| | | | | |
| | | | | |
| | | | | | |||||||||||||
Calquence | | | | | | | | | | | | | – | – | | ||||||||||||||||
Koselugo | | | | – | | – | | – | – | | – | – | – | – | – | ||||||||||||||||
Enhertu | | – | | | | – | – | – | – | – | – | – | – | – | – | ||||||||||||||||
Orpathys | | – | – | – | | – | – | – | – | – | – | – | – | – | – | ||||||||||||||||
Zoladex |
| | | | | |
| | | | | |
| | | | | | |||||||||||||
Faslodex |
| | | | | |
| | | | | |
| | | | | | |||||||||||||
Iressa |
| | | | | |
| | | | | |
| | | | | | |||||||||||||
Casodex |
| | – | | | |
| | – | | | |
| | – | | | | |||||||||||||
Arimidex |
| | – | | | |
| | – | | | |
| | – | | | | |||||||||||||
Others |
| | – | | | |
| | – | | | |
| | – | | | | |||||||||||||
| | | | | |
| | | | | |
| | | | | | ||||||||||||||
Cardiovascular, Renal & Metabolism: |
|
|
| ||||||||||||||||||||||||||||
Farxiga |
| | | | | |
| | | | | |
| | | | | | |||||||||||||
Brilinta |
| | | | | |
| | | | | |
| | | | | | |||||||||||||
Bydureon |
| | | | | |
| | | | | |
| | | | | | |||||||||||||
Onglyza |
| | | | | |
| | | | | |
| | | | | | |||||||||||||
Byetta |
| | | | | |
| | | | | |
| | | | | | |||||||||||||
Other Diabetes | | | | | | | | | | | | | | | | ||||||||||||||||
Lokelma | | | | | | | | | | | – | | | – | | ||||||||||||||||
Roxadustat | | – | – | – | | – | – | – | – | – | – | – | – | – | – | ||||||||||||||||
Crestor |
| | | | | |
| | | | | |
| | | | | | |||||||||||||
Seloken/Toprol-XL |
| | | | | |
| | | | | |
| | | | | | |||||||||||||
Atacand |
| | | | – | |
| | | | | |
| | | | | | |||||||||||||
Others |
| | – | | | |
| | – | | | |
| | ( | | | | |||||||||||||
| | | | | |
| | | | | |
| | | | | | ||||||||||||||
Respiratory & Immunology: |
|
|
| ||||||||||||||||||||||||||||
Symbicort |
| | | | | |
| | | | | |
| | | | | | |||||||||||||
Fasenra |
| | | | | |
| | | | | |
| | | | | | |||||||||||||
Pulmicort | | | | | | | | | | | | | | | | ||||||||||||||||
Daliresp/Daxas |
| | | | | |
| | | | | |
| | | | | | |||||||||||||
Breztri | | | | | | | | – | | | – | – | – | | | ||||||||||||||||
Bevespi | | | | – | | | | | – | | – | | – | – | | ||||||||||||||||
Saphnelo | – | | – | – | | – | – | – | – | – | – | – | – | – | – | ||||||||||||||||
Others |
| | | | | |
| | | | | |
| | | | | | |||||||||||||
| | | | | |
| | | | | |
| | | | | | ||||||||||||||
Rare Disease: | |||||||||||||||||||||||||||||||
Soliris | | | | | | – | – | – | – | – | – | – | – | – | – | ||||||||||||||||
Ultomiris | | | | | | – | – | – | – | – | – | – | – | – | – | ||||||||||||||||
Strensiq | | | | | | – | – | – | – | – | – | – | – | – | – | ||||||||||||||||
Andexxa | – | | | – | | – | – | – | – | – | – | – | – | – | – | ||||||||||||||||
Kanuma | | | | | | – | – | – | – | – | – | – | – | – | – | ||||||||||||||||
| | | | | – | – | – | – | – | – | – | – | – | – | |||||||||||||||||
Other: |
|
|
| ||||||||||||||||||||||||||||
Nexium |
| | | | | |
| | | | | |
| | | | | | |||||||||||||
Synagis |
| | | | | |
| – | | | – | |
| – | | | – | | |||||||||||||
FluMist |
| | | | | |
| | | | | |
| – | | | – | | |||||||||||||
Losec/Prilosec |
| | | | | |
| | | | | |
| | | | | | |||||||||||||
Seroquel XR/IR | | | | | | | | | | | | | | | | ||||||||||||||||
Others |
| | | | | |
| | | | | |
| | | | | | |||||||||||||
| | | | | |
| | | | | |
| | | | | | ||||||||||||||
COVID-19: | |||||||||||||||||||||||||||||||
Vaxzevria | | | | | | – | – | | – | | – | – | – | – | – | ||||||||||||||||
Evusheld | | – | | – | | – | – | – | – | – | – | – | – | – | – | ||||||||||||||||
| | | | | – | – | | – | | – | – | – | – | – | |||||||||||||||||
Product Sales |
| | | | | |
| | | | | |
| | | | | |
Rebates and chargebacks in the US
The major market where estimates are seen as significant is the US. When invoicing Product Sales in the US, we estimate the rebates and chargebacks we expect to pay. The adjustment in respect of prior year net US Product Sales revenue in 2021 was
F-19
The adjustment in respect of the prior year net US Product sales revenue, excluding the Rare Disease disease area in 2021 was
These values demonstrate the level of sensitivity; further meaningful sensitivity is not able to be provided due to the large volume of variables that contribute to the overall rebates, chargebacks, returns and other revenue accruals.
Collaboration Revenue
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Royalty income | | | | ||||
Global co-development and commercialisation of Lynparza and Koselugo with MSD |
| |
| |
| | |
Transfer of rights to Zoladex in the US and Canada to TerSera |
| – |
| |
| – | |
Enhertu: share of gross profits | | | – | ||||
Roxadustat: share of gross profits | | | – | ||||
Nexium: sale of rights | | – | – | ||||
Licence agreement for Crestor in Spain with Almirall |
| – |
| – |
| | |
Co-development and commercialisation of MEDI8897 with Sanofi |
| – |
| – |
| | |
Grant of authorised generic rights to various medicines in Japan | – | – | | ||||
Other collaboration revenue | | | | ||||
| |
| |
| |
Collaboration Revenue includes some income that does not arise from the satisfaction of performance obligations, in particular profit share entitlements arising from product sales made by collaborators who have licenced intellectual property to AstraZeneca. $
2 Operating profit
Operating profit includes the following significant items:
Cost of sales
In 2021, Cost of sales includes a charge of $
During the year $
Selling, general and administrative expense
In 2021, Selling, general and administrative expense includes a charge of $
In 2021, Selling, general and administrative expense also includes a charge of $
In 2021, Selling, general and administrative expense also includes a charge of $
Research and development expense: Government grants
During the year $
Other operating income and expense
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Royalties |
|
|
|
|
|
| |
Income |
| |
| |
| | |
Amortisation |
| ( |
| ( |
| ( | |
Gains on disposal of intangible assets |
| |
| |
| | |
Gains on disposal of investments in associates and joint ventures | | – | – | ||||
Net (losses)/gains on disposal of other non-current assets |
| ( |
| |
| ( | |
Impairment of property, plant and equipment | – | ( | – | ||||
Other income1 |
| |
| |
| | |
Other expense |
| ( |
| ( |
| ( | |
Other operating income and expense |
| |
| |
| |
| 1 | Other income in 2021 includes $ |
Royalty amortisation relates to intangible assets recorded in respect of income streams acquired with MedImmune.
Gains on disposal of intangible assets in 2021 includes $
F-20
Gains on disposal of intangible assets in 2020 includes $
Gains on disposal of intangible assets in 2019 includes $
Gains on disposal of investments in associates and joint ventures in 2021 relates to the disposal of the
As part of the total consideration received in respect of the agreement to sell US rights to Synagis in 2019, $
Restructuring costs
In conjunction with the acquisition of Alexion, the enlarged Group has initiated a comprehensive Post Alexion Acquisition Group Review, aimed at integrating systems, structure and processes, optimising the global footprint and prioritising resource allocations and investments. These activities are expected to be substantially complete by the end of 2025, with a number of planned activities having commenced in late 2021. The Group has also continued to progress other legacy restructuring programmes, including the Global Post-Pandemic New Ways of Working programme that was initiated in 2020 in response to the changing business environment, accelerated by the COVID-19 pandemic.
During 2021, the Group has incurred $
Total restructuring costs in 2021 included impairments of property, plant and equipment ($
The tables below show the costs that have been charged in respect of restructuring programmes by cost category and type. Severance provisions are detailed in Note 21.
| 2021 |
| 2020 |
| 2019 | ||
$m | $m | $m | |||||
Cost of sales |
| |
| |
| | |
Research and development expense |
| |
| |
| | |
Selling, general and administrative expense |
| |
| |
| | |
Other operating income and expense |
| – |
| |
| – | |
Total charge |
| |
| |
| |
| 2021 |
| 2020 |
| 2019 | ||
$m | $m | $m | |||||
Severance costs |
| |
| |
| | |
Accelerated depreciation and impairment charges1 |
| |
| |
| ( | |
Other2 |
| |
| |
| | |
Total charge |
| |
| |
| |
| 1 | Included within accelerated depreciation and impairment in 2019 is a credit relating to the impairment reversal of two manufacturing sites in Colorado, US. Refer to Note 7 for further details. |
| 2 | Other costs are those incurred in designing and implementing the Group’s various restructuring initiatives, including costs of integrating systems, structure and processes as part of our Post Alexion Acquisition Group Review, costs relating to the Alexion acquisition, internal project costs and external consultancy fees. |
Financial instruments
Included within Operating profit are the following net gains and losses on financial instruments:
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Losses on forward foreign exchange contracts |
| ( |
| ( |
| ( | |
(Losses)/gains on receivables and payables | ( | | | ||||
Total |
| ( |
| |
| ( |
Impairment charges
Details of impairment charges for 2021, 2020 and 2019 are included in Notes 7 and 10.
3 Finance income and expense
F-21
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Finance income |
|
|
|
|
|
| |
Returns on fixed deposits and equity securities |
| |
| |
| | |
Returns on short-term deposits |
| |
| |
| | |
Fair value gains on debt and interest rate swaps |
| – |
| |
| | |
Discount unwind on other long-term assets |
| – |
| |
| | |
Interest income on income tax balances | | | | ||||
Total |
| |
| |
| | |
Finance expense |
|
|
| ||||
Interest on debt and commercial paper |
| ( |
| ( |
| ( | |
Interest on overdrafts, lease liabilities and other financing costs |
| ( |
| ( |
| ( | |
Net interest on post-employment defined benefit plan net liabilities (Note 22) |
| ( |
| ( |
| ( | |
Net exchange losses |
| ( |
| ( |
| ( | |
Discount unwind on contingent consideration arising from business combinations (Note 20) |
| ( |
| ( |
| ( | |
Discount unwind on other long-term liabilities1 |
| ( |
| ( |
| ( | |
Fair value losses on debt and interest rate swaps |
| ( |
| – |
| – | |
Interest expense on income tax balances | ( | ( | ( | ||||
Total |
| ( |
| ( |
| ( | |
Net finance expense |
| ( |
| ( |
| ( |
| 1 | Included within Discount unwind on other long-term liabilities is $ |
Financial instruments
Included within finance income and expense are the following net gains and losses on financial instruments:
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Interest and fair value adjustments in respect of debt designated at fair value through profit or loss, net of derivatives |
| ( |
| ( |
| ( | |
Interest and changes in carrying values of debt designated as hedged items in fair value hedges, net of derivatives |
| ( |
| ( |
| ( | |
Interest and fair value changes on fixed and short-term deposits, equity securities, other derivatives and tax balances |
| |
| |
| | |
Interest on debt, commercial paper, overdrafts and lease liabilities held at amortised cost |
| ( |
| ( |
| ( |
Fair value loss of $
Fair value loss of $
4 Taxation
Taxation recognised in the Consolidated Statement of Comprehensive Income is as follows:
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Current tax expense |
|
|
|
|
|
| |
Current year |
| |
| |
| | |
Adjustment to prior years |
| ( |
| ( |
| | |
Total |
| |
| |
| | |
Deferred tax expense |
|
|
| ||||
Origination and reversal of temporary differences |
| ( |
| ( |
| ( | |
Adjustment to prior years |
| ( |
| ( |
| ( | |
Total |
| ( |
| ( |
| ( | |
Taxation recognised in the profit for the period |
| ( |
| |
| |
F-22
Taxation relating to components of Other comprehensive income is as follows:
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Current and deferred tax |
|
|
|
|
|
| |
Items that will not be reclassified to profit or loss: |
|
|
|
|
|
| |
Remeasurement of the defined benefit liability |
| ( |
| |
| | |
Net losses/(gains) on equity investments measured at fair value through other comprehensive income | | ( | ( | ||||
Deferred tax (credit)/charge relating to change of tax rates |
| |
| |
| – | |
Total |
| |
| ( |
| | |
Items that may be reclassified subsequently to profit or loss: |
|
|
| ||||
Foreign exchange arising on consolidation |
| |
| ( |
| | |
Foreign exchange arising on designated borrowings in net investment hedges |
| ( |
| |
| | |
Deferred tax charge relating to change of tax rates |
| |
| – |
| – | |
Total |
| |
| ( |
| | |
Taxation relating to components of other comprehensive income |
| |
| ( |
| |
The reported tax rate in the year was
The income tax paid for the year was $
Taxation has been provided at current rates on the profits earned for the periods covered by the Group Financial Statements. The 2021 prior period current tax adjustment relates mainly to tax accrual to tax return adjustments. The 2020 prior period current tax adjustment relates mainly to net reductions in provisions for tax contingencies and tax accrual to tax return adjustments. The 2019 prior period current tax adjustments relate mainly to net increases in provisions for tax contingencies and tax accrual to tax return adjustments.
The 2021 prior period deferred tax adjustments relate mainly to tax accrual to tax return adjustments and updates to estimates of prior period tax liabilities following settlements with tax authorities. The 2020 prior period deferred tax adjustments relate mainly to tax accrual to tax return adjustments offset by net increases in provisions for tax contingencies. The 2019 prior period deferred tax adjustments relate mainly to tax accrual to return adjustments.
To the extent that dividends remitted from overseas subsidiaries, joint ventures and associates are expected to result in additional taxes, appropriate amounts have been provided for. Unremitted earnings or differences in the carrying value and tax basis of investments may be liable to additional taxes if distributed as dividends or on a liquidation event. Deferred tax is provided for such differences in relation to Group entities where management is intending to remit earnings in the foreseeable future. The aggregate amount of gross temporary differences associated with investments in subsidiaries, partnerships and branches for which deferred tax liabilities have not been recognised totalled approximately $
Factors affecting future tax charges
As a Group with worldwide operations, AstraZeneca is subject to several factors that may affect future tax charges, principally the levels and mix of profitability in different jurisdictions, transfer pricing regulations, tax rates imposed and tax regime reforms. In 2021, the UK Government enacted legislation to increase the main rate of UK statutory Corporation Tax to
Tax reconciliation to UK statutory rate
The table below reconciles the UK statutory tax charge to the Group’s total tax (credit)/charge:
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
(Loss)/profit before tax |
| ( |
| |
| | |
Notional taxation charge at UK corporation tax rate of |
| ( |
| |
| | |
Differences in effective overseas tax rates |
| |
| ( |
| ( | |
Deferred tax charge relating to change in tax rates1 |
| |
| |
| | |
Unrecognised deferred tax asset2 |
| |
| |
| ( | |
Items not deductible for tax purposes |
| |
| |
| | |
Items not chargeable for tax purposes |
| ( |
| ( |
| ( | |
Other items3 |
| ( |
| ( |
| | |
Adjustments in respect of prior periods4 |
| ( |
| ( |
| ( | |
Total tax (credit)/charge for the year |
| ( |
| |
| |
| 1 | The 2021 item relates to substantive enactment of the increase in UK Corporation Tax rate from |
| 2 | The 2021 item includes a $ |
| 3 | Other items in 2021 relate to a net credit of $ |
| 4 | Further details explaining the adjustments in respect of prior periods is set out on page 149. |
F-23
AstraZeneca is domiciled in the UK but operates in other countries where the tax rates and laws are different to those in the UK. The impact on differences in effective overseas tax rates on the Group’s overall tax charge is noted above. Profits arising from our manufacturing operation in Puerto Rico are granted special status and are taxed at a reduced rate compared with the normal rate of tax in that territory under a tax incentive grant continuing until 2031.
Deferred tax
The total movement in the net deferred tax balance in the year was $
| Intangibles, |
| Pension and |
| Elimination of |
|
| Losses and |
| Accrued |
|
| |||
property, plant | post-retirement | unrealised profit | Untaxed | tax credits | expenses |
| |||||||||
& equipment | 1 | benefits | on inventory | reserves | 2 | carried forward | and other | Total |
| ||||||
$m | $m | $m | $m | $m | $m | $m |
| ||||||||
Net deferred tax balance at 1 January 2019 |
| ( | | | ( | | | ( | |||||||
Income statement | | ( | | ( | ( | | | ||||||||
Other comprehensive income | | | – | – | – | ( | | ||||||||
Equity | – | – | – | – | – | | | ||||||||
Exchange |
| | ( | | | | | | |||||||
Net deferred tax balance at 31 December 2019 |
| ( | | | ( | | | | |||||||
Income statement | ( | ( | | ( | | | | ||||||||
Other comprehensive income | ( | | – | ( | – | | | ||||||||
Equity |
| – | – | – | – | – | ( | ( | |||||||
Exchange |
| ( | | | ( | | | | |||||||
Net deferred tax balance at 31 December 2020 |
| ( | | | ( | | | | |||||||
Income statement |
| | ( | ( | ( | | | | |||||||
Other comprehensive income |
| | | – | – | – | | | |||||||
Equity | – | – | – | – | – | | | ||||||||
Additions through business combinations3 | ( | | | – | | ( | ( | ||||||||
Exchange |
| | ( | ( | | ( | ( | | |||||||
Net deferred tax balance at 31 December 20214 |
| ( | | | ( | | | ( |
1 | Includes deferred tax of $ |
2 | Untaxed reserves relate to taxable profits where the tax liability is deferred to later periods. |
3 | The deferred tax liability of $ |
4 | The Group recognises deferred tax assets to the extent that it is probable that sufficient future taxable profits will arise, against which these deductible temporary differences can be utilised. The US includes a net deferred tax asset of $ |
The net deferred tax balance, before the offset of balances within countries, consists of:
| Intangibles, |
| Pension and |
| Elimination of |
|
| Losses and |
| Accrued |
|
| |||
property, plant | post-retirement | unrealised profit | Untaxed | tax credits | expenses |
| |||||||||
& equipment | benefits | on inventory | reserves | carried forward | and other | Total |
| ||||||||
$m | $m | $m | $m | $m | $m | $m |
| ||||||||
Deferred tax assets at 31 December 2019 |
| | | | – | | | | |||||||
Deferred tax liabilities at 31 December 2019 |
| ( | ( | ( | ( | ( | ( | ( | |||||||
Net deferred tax balance at 31 December 2019 |
| ( | | | ( | | | | |||||||
Deferred tax assets at 31 December 2020 |
| | | | – | | | | |||||||
Deferred tax liabilities at 31 December 2020 |
| ( | ( | ( | ( | ( | ( | ( | |||||||
Net deferred tax balance at 31 December 2020 |
| ( | | | ( | | | | |||||||
Deferred tax assets at 31 December 2021 |
| | | | – | | | | |||||||
Deferred tax liabilities at 31 December 2021 |
| ( | ( | ( | ( | ( | ( | ( | |||||||
Net deferred tax balance at 31 December 2021 |
| ( | | | ( | | | ( |
Analysed in the Consolidated Statement of Financial Position, after offset of balances within countries, as follows:
2021 | 2020 | 2019 |
| ||||
$m | $m | $m |
| ||||
Deferred tax assets |
| |
| |
| | |
Deferred tax liabilities |
| ( |
| ( |
| ( | |
Net deferred tax balance |
| ( |
| |
| |
F-24
Unrecognised deferred tax assets
Deferred tax assets (DTA) of $
2021 | 2021 | 2020 | 2020 | 2019 | 2019 | ||||||||
Temporary | Unrecognised | Temporary | Unrecognised | Temporary | Unrecognised | ||||||||
differences | DTA | differences | DTA | differences | DTA | ||||||||
$m | $m | $m | $m | $m | $m | ||||||||
Trading and capital losses expiring: |
|
| |||||||||||
Within 10 years | | | | – | | | |||||||
More than 10 years | | | – | – | | – | |||||||
Indefinite | | | | | | | |||||||
| | | | | | | |||||||
Tax credits and State tax losses expiring: | |||||||||||||
Within 10 years | | | | ||||||||||
More than 10 years | | | | ||||||||||
Indefinite | | | | ||||||||||
| | | |||||||||||
Total |
| | | |
5 Earnings per $0.25 Ordinary Share
| 2021 |
| 2020 |
| 2019 |
| ||||
Profit for the year attributable to equity holders ($m) |
| |
| |
| | ||||
Basic earnings per Ordinary Share | $ | $ | $ | |||||||
Diluted earnings per Ordinary Share | $ | $ | $ | |||||||
Weighted average number of Ordinary Shares in issue for basic earnings (millions) |
| |
| |
| | ||||
Dilutive impact of share options outstanding (millions) |
| |
| |
| – | ||||
Diluted weighted average number of Ordinary Shares in issue (millions) |
| |
| |
| |
The earnings figures used in the calculations above are post-tax.
6 Segment information
Following the acquisition of Alexion, the Group has reviewed its assessment of reportable segments under IFRS 8 ‘Operating Segments’ and concluded that the Group continues to have
This determination is considered to be a Key Judgement and this judgement has been taken with reference to the following factors:
1 The level of integration across the different functions of the Group’s pharmaceutical business:
AstraZeneca is engaged in a single business activity of pharmaceuticals and the Group does not have multiple operating segments. AstraZeneca’s pharmaceuticals business consists of the discovery and development of new products, which are then manufactured, marketed and sold. All of these functional activities take place (and are managed) globally on a highly integrated basis. These individual functional areas are not managed separately.
2 The identification of the Chief Operating Decision Maker (CODM) and the nature and extent of the financial information reviewed by the CODM:
The SET, established and chaired by the CEO, is the vehicle through which the CEO exercises the authority delegated to him from the Board for the management, development and performance of AstraZeneca as a whole. It is considered that the SET is AstraZeneca’s Chief Operating Decision Making body (as defined by IFRS 8). The operation of the SET is principally driven by the management of the Commercial operations, R&D, manufacturing and supply and enabling functions. All significant operating decisions are undertaken by the SET. While members of the SET have responsibility for implementation of decisions in their respective areas, operating decision making is at SET level as a whole. Where necessary, these are implemented through cross-functional sub-committees that consider the Group-wide impact of a new decision. For example, product launch decisions would be initially considered by the SET and, on approval, passed to an appropriate sub team for implementation. The ability of the enterprise to develop, produce, deliver and commercialise a wide range of pharmaceutical products are central to the SET decision-making process.
In assessing performance, the SET reviews financial information on an integrated basis for the Group as a whole, substantially in the form of, and on the same basis as, the Group’s IFRS Financial Statements. The high upfront cost of discovering and developing new products, coupled with the relatively insignificant and stable unit cost of production, means that there is not the clear link that exists in many manufacturing businesses between the revenue generated on an individual product sale and the associated cost and hence margin generated on a product. Consequently, the profitability of individual drugs or classes of drugs is not considered a key measure of performance for the business and is not monitored by the SET. The focus of additional financial information reviewed is at brand sales and gross margin level within specific geographies. Expenditure analysis is completed for the science units, operations and enabling functions; there is no allocation of these centrally managed group costs to the individual product or brands. The bonus of SET members’ continues to be derived from the Group scorecard outcome as discussed in our Directors’ Remuneration Report.
3 How resources are allocated:
Resources are allocated on a Group-wide basis according to need. In particular, capital expenditure, in-licensing, and R&D resources are allocated between activities on merit, based on overall therapeutic considerations and strategy under the aegis of the Group’s Early Stage Product Committees and Late Stage Product Committees.
F-25
Geographic areas
The following table shows information for Total Revenue by geographic area and material countries. The additional tables show the Operating profit and Profit before tax made by companies located in that area, together with Non-current assets, Total assets, assets acquired, net operating assets, and Property, plant and equipment owned by the same companies. Product Sales by geographic market are included in the area/country where the legal entity resides and from which those sales were made.
| Total Revenue |
| |||||
2021 |
| 2020 |
| 2019 |
| ||
$m | $m | $m |
| ||||
UK |
| |
| |
| | |
|
|
| |||||
Rest of Europe |
|
|
| ||||
France |
| |
| |
| | |
Germany |
| |
| |
| | |
Italy |
| |
| |
| | |
Spain |
| |
| |
| | |
Sweden |
| |
| |
| | |
Others |
| |
| |
| | |
| |
| |
| | ||
The Americas |
|
|
| ||||
Canada |
| |
| |
| | |
US |
| |
| |
| | |
Others |
| |
| |
| | |
| |
| |
| | ||
Asia, Africa & Australasia |
|
|
| ||||
Australia |
| |
| |
| | |
China |
| |
| |
| | |
Japan |
| |
| |
| | |
Others |
| |
| |
| | |
| |
| |
| | ||
Total Revenue |
| |
| |
| |
Total Revenue outside of the UK totalled $
Operating profit/(loss) |
| (Loss)/profit before tax |
| ||||||||||
2021 | 2020 | 2019 | 2021 | 2020 | 2019 |
| |||||||
| $m |
| $m |
| $m |
| $m |
| $m |
| $m |
| |
UK |
| ( |
| |
| |
| ( |
| |
| | |
Rest of Europe |
| |
| |
| |
| |
| |
| | |
The Americas |
| ( |
| |
| ( |
| ( |
| |
| ( | |
Asia, Africa & Australasia |
| |
| |
| |
| |
| |
| | |
Continuing operations |
| |
| |
| |
| ( |
| |
| | |
| Non-current assets | 1 | Total assets |
| |||||||||
2021 | 2020 | 2019 | 2021 | 2020 | 2019 |
| |||||||
$m | $m | $m | $m | $m | $m |
| |||||||
UK | |
| |
| | |
| |
| | |||
Rest of Europe | |
| |
| | |
| |
| | |||
The Americas | |
| |
| | |
| |
| | |||
Asia, Africa & Australasia | |
| |
| | |
| |
| | |||
Continuing operations | |
| |
| | | | |
Assets acquired | 2 | Net operating assets | 3 | ||||||||||
2021 | 2020 | 2019 | 2021 | 2020 | 2019 |
| |||||||
| $m |
| $m |
| $m |
| $m |
| $m |
| $m |
| |
UK |
| |
| |
| | |
| |
| | ||
Rest of Europe |
| |
| |
| | |
| |
| | ||
The Americas |
| |
| |
| | |
| |
| | ||
Asia, Africa & Australasia |
| |
| |
| | |
| |
| | ||
Continuing operations |
| |
| |
| | |
| |
| | ||
| 1 | Non-current assets exclude Deferred tax assets and Derivative financial instruments. |
| 2 | Included in Assets acquired are those assets that are expected to be used during more than one period (Property, plant and equipment, Goodwill and Intangible assets) and include those acquired through business combinations (Note 27). |
| 3 | Net operating assets exclude short-term investments, cash, short-term borrowings, loans, Derivative financial instruments, retirement benefit obligations and non-operating receivables and payables. |
Property, plant and equipment |
| ||||||
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
UK |
| |
| |
| | |
Ireland | | – | – | ||||
Sweden |
| |
| |
| | |
US |
| |
| |
| | |
Rest of the world |
| |
| |
| | |
Continuing operations |
| |
| |
| | |
F-26
Geographic markets
The table below shows Product Sales in each geographic market in which customers are located.
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
UK |
| |
| |
| | |
Rest of Europe |
| |
| |
| | |
The Americas |
| |
| |
| | |
Asia, Africa & Australasia |
| |
| |
| | |
Continuing operations |
| |
| |
| |
Product Sales are recognised when control of the goods has been transferred to a third party. A significant proportion of this is upon delivery of the products to wholesalers.
7 Property, plant and equipment
|
|
| Assets in |
| Total property, |
| |||
Land and | Plant and | course of | plant and |
| |||||
buildings | equipment | construction | equipment |
| |||||
$m | $m | $m | $m |
| |||||
Cost | |||||||||
At 1 January 2019 | | | | | |||||
Capital expenditure | | | | | |||||
Transfer of assets into use | | | ( | – | |||||
Disposals and other movements | ( | ( | ( | ( | |||||
Exchange adjustments | ( | ( | | ( | |||||
At 31 December 2019 | | | | | |||||
Capital expenditure | | | | | |||||
Transfer of assets into use | | | ( | – | |||||
Disposals and other movements | ( | ( | ( | ( | |||||
Exchange adjustments | | | | | |||||
At 31 December 2020 | | | | | |||||
Additions through business combinations (Note 27) | | | | | |||||
Capital expenditure | | | | | |||||
Transfer of assets into use | | | ( | – | |||||
Disposals and other movements | ( | ( | ( | ( | |||||
Exchange adjustments | ( | ( | ( | ( | |||||
At 31 December 2021 | | | | | |||||
Depreciation and impairment | |||||||||
At 1 January 2019 | | | – | | |||||
Depreciation charge for the year | | | – | | |||||
Impairment (reversal)/charge | ( | | – | ( | |||||
Disposals and other movements | ( | ( | – | ( | |||||
Exchange adjustments | ( | ( | – | ( | |||||
At 31 December 2019 | | | – | | |||||
Depreciation charge for the year | | | – | | |||||
Impairment (reversal)/charge | ( | | | | |||||
Disposals and other movements | ( | ( | ( | ( | |||||
Exchange adjustments | | | – | | |||||
At 31 December 2020 | | | – | | |||||
Depreciation charge for the year | | | – | | |||||
Impairment (reversal)/charge | ( | | | | |||||
Disposals and other movements | ( | ( | ( | ( | |||||
Exchange adjustments | ( | ( | – | ( | |||||
At 31 December 2021 | | | – | | |||||
Net book value | |||||||||
At 31 December 2019 | | | | | |||||
At 31 December 2020 | | | | | |||||
At 31 December 2021 | | | | |
Impairment charges in 2021 totalling $
Impairment charges in 2019 were recognised for Land and buildings and Plant and equipment as a result of the announcement of the closure of the Wedel manufacturing site and the cessation of specific operations in Algeria. These charges were recognised in Cost of sales in 2019. Impairment reversals were recognised in 2019 of $
F-27
Included within other movements in 2019 is a of $
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
The net book value of land and buildings comprised: | |||||||
Freeholds | | | | ||||
Leaseholds | | | |
8 Leases
Right-of-use assets
|
|
|
| Total right- |
| ||||
Land and | Motor | of-use |
| ||||||
buildings | vehicles | Other | assets |
| |||||
$m | $m | $m | $m |
| |||||
Cost |
|
|
|
|
|
|
|
| |
At 1 January 2019 |
| – | – | – | – | ||||
Opening balance |
| | | | | ||||
Additions – separately acquired |
| | | | | ||||
Disposals and other movements |
| ( | ( | | ( | ||||
Exchange adjustments |
| | – | – | | ||||
At 31 December 2019 |
| | | | | ||||
Additions – separately acquired |
| | | | | ||||
Disposals and other movements |
| – | ( | ( | ( | ||||
Exchange adjustments |
| | | | | ||||
At 31 December 2020 |
| | | | | ||||
Additions through business combinations (Note 27) | | | – | | |||||
Additions – separately acquired | | | | | |||||
Disposals and other movements | | ( | ( | ( | |||||
Exchange adjustments | ( | ( | ( | ( | |||||
At 31 December 2021 | | | | | |||||
Depreciation and impairment | |||||||||
At 1 January 2019 |
| – | – | – | – | ||||
Depreciation charge for the year |
| | | | | ||||
Impairment charge |
| | – | – | | ||||
Disposals and other movements |
| ( | ( | | ( | ||||
Exchange adjustments | | – | – | | |||||
At 31 December 2019 |
| | | | | ||||
Depreciation charge for the year |
| | | | | ||||
Disposals and other movements |
| ( | ( | ( | ( | ||||
Exchange adjustments | | | – | | |||||
At 31 December 2020 |
| | | | | ||||
Depreciation charge for the year | | | | | |||||
Disposals and other movements | ( | ( | – | ( | |||||
Exchange adjustments | ( | ( | – | ( | |||||
At 31 December 2021 | | | | | |||||
Net book value |
| ||||||||
At 31 December 2019 | | | | | |||||
At 31 December 2020 | | | | | |||||
At 31 December 2021 | | | | |
Lease Liability
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
The present value of lease liabilities is as follows: | |||||||
Within one year | ( | ( | ( | ||||
Later than one year and not later than five years | ( | ( | ( | ||||
Later than five years | ( | ( | ( | ||||
Total lease liabilities | ( | ( | ( |
The interest expense on lease liabilities included within finance costs was $
The total cash outflow for leases in 2021 was $
9 Goodwill
F-28
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Cost | |||||||
At 1 January | | | | ||||
Additions through business combinations (Note 27) | | – | – | ||||
Exchange and other adjustments | ( | | ( | ||||
At 31 December | | | | ||||
Amortisation and impairment losses | |||||||
At 1 January | | | | ||||
Exchange and other adjustments | ( | | ( | ||||
At 31 December | | | | ||||
Net book value | |||||||
At 31 December | | | |
Goodwill is tested for impairment at the operating segment level, this being the level at which goodwill is monitored for internal management purposes. As detailed in Note 6, the Group does not have multiple operating segments and is engaged in a single business activity of pharmaceuticals.
Recoverable amount is determined on a fair value less costs to sell basis using the market value of the Company’s outstanding Ordinary Shares. Our market capitalisation is compared to the book value of the Group’s net assets and this indicates a significant surplus at 31 December 2021 (and 31 December 2020 and 31 December 2019).
10 Intangible assets
| Product, |
|
| Software |
|
| |||
marketing and | Other | development |
| ||||||
distribution rights | intangibles | costs | Total |
| |||||
$m | $m | $m | $m |
| |||||
Cost |
|
|
|
|
|
|
|
| |
At 1 January 2019 |
| | | | | ||||
Additions – separately acquired |
| | | | | ||||
Disposals |
| ( | – | ( | ( | ||||
Exchange and other adjustments |
| ( | | | ( | ||||
At 31 December 2019 |
| | | | | ||||
Additions – separately acquired |
| | | | | ||||
Disposals |
| ( | ( | ( | ( | ||||
Exchange and other adjustments |
| | | | | ||||
At 31 December 2020 |
| | | | | ||||
Additions through business combinations (Note 27) | | | | | |||||
Additions – separately acquired |
| | | | | ||||
Transferred to Assets held for sale (Note 18) | ( | ( | – | ( | |||||
Disposals |
| ( | ( | ( | ( | ||||
Exchange and other adjustments |
| ( | ( | ( | ( | ||||
At 31 December 2021 | | | | | |||||
Amortisation and impairment losses |
|
|
|
|
|
|
|
| |
At 1 January 2019 |
| | | | | ||||
Amortisation for year |
| | | | | ||||
Impairment charges |
| | – | | | ||||
Impairment reversals | ( | – | – | ( | |||||
Disposals |
| ( | – | ( | ( | ||||
Exchange and other adjustments |
| ( | | | ( | ||||
At 31 December 2019 |
| | | | | ||||
Amortisation for year |
| | | | | ||||
Impairment charges |
| | – | – | | ||||
Impairment reversals | ( | – | – | ( | |||||
Disposals |
| ( | ( | ( | ( | ||||
Exchange and other adjustments |
| | | ( | | ||||
At 31 December 2020 |
| | | | | ||||
Amortisation for year |
| | | | | ||||
Impairment charges |
| | – | | | ||||
Transferred to Assets held for sale (Note 18) | ( | ( | – | ( | |||||
Disposals |
| ( | ( | ( | ( | ||||
Exchange and other adjustments |
| ( | ( | ( | ( | ||||
At 31 December 2021 |
| | | | | ||||
Net book value |
|
|
|
|
|
|
|
| |
At 31 December 2019 |
| | | | | ||||
At 31 December 2020 |
| | | | | ||||
At 31 December 2021 |
| | | | |
F-29
2021 | 2020 | 2019 | |||||||
$m | $m | $m | |||||||
Net book value | |||||||||
Current intangible assets | | – | – | ||||||
Non-current intangible assets | | | | ||||||
At 31 December | | | |
Other intangibles consist mainly of research and device technologies and the Alexion brand name.
Included within Additions − separately acquired are amounts of $
Amortisation charges are recognised in profit as follows:
| Product, |
|
| Software |
|
| |||
marketing and | Other | development |
| ||||||
distribution rights | intangibles | costs | Total |
| |||||
$m | $m | $m | $m |
| |||||
Year ended 31 December 2019 |
|
|
|
|
|
|
|
| |
Cost of sales |
| | – | – | | ||||
Research and development expense |
| – | | – | | ||||
Selling, general and administrative expense |
| | | | | ||||
Other operating income and expense |
| – | | – | | ||||
Total |
| | | | | ||||
Year ended 31 December 2020 |
|
|
|
|
|
|
|
| |
Cost of sales |
| | – | – | | ||||
Research and development expense |
| – | | – | | ||||
Selling, general and administrative expense |
| | | | | ||||
Other operating income and expense |
| – | | – | | ||||
Total |
| | | | | ||||
Year ended 31 December 2021 |
|
|
|
|
|
|
|
| |
Cost of sales |
| | – | – | | ||||
Research and development expense |
| – | | – | | ||||
Selling, general and administrative expense |
| | | | | ||||
Other operating income and expense |
| – | | – | | ||||
Total |
| | | | |
Net impairment charges/(reversals) are recognised in profit as follows:
| Product, |
|
| Software |
|
| |||
marketing and | Other | development |
| ||||||
distribution rights | intangibles | costs | Total |
| |||||
$m | $m | $m | $m |
| |||||
Year ended 31 December 2019 |
|
|
|
|
|
|
|
| |
Research and development expense |
| | – | – | | ||||
Selling, general and administrative expense | | – | | | |||||
Other operating income and expense |
| ( | – | – | ( | ||||
Total |
| | – | | | ||||
Year ended 31 December 2020 |
| ||||||||
Research and development expense |
| | – | – | | ||||
Selling, general and administrative expense |
| | – | – | | ||||
Total |
| | – | – | | ||||
Year ended 31 December 2021 |
| ||||||||
Research and development expense |
| | – | – | | ||||
Selling, general and administrative expense |
| | – | | | ||||
Total |
| | – | | |
Impairment charges and reversals
Intangible assets under development and not available for use are tested annually for impairment and other intangible assets are tested when there is an indication of impairment loss or reversal. Where testing is required, the recoverable amount of the assets is estimated in order to determine the extent of the impairment loss or reversal. Where it is not possible to estimate the recoverable amount of an individual asset, the Group estimates the recoverable amount of the Cash Generating Unit (CGU) to which it belongs. The Group considers that as the intangible assets are linked to individual products and that product cash flows are considered to be largely independent of other product cash flows, the CGU for intangibles is at the product level. Group level budgets and forecasts include forecast capital investment and operational impacts related to sustainability projects, and form the basis for the value in use models used for impairment testing.
An asset’s recoverable amount is determined as the higher of an asset’s or CGU’s fair value less costs to sell or value in use, in both cases using discounted cash flow calculations where the asset’s expected post-tax cash flows are risk-adjusted over their estimated remaining period of expected economic benefit. Where the value in use approach is used, the risk-adjusted cash flows are discounted using AstraZeneca’s post-tax weighted average cost of capital (
F-30
The estimates used in calculating the recoverable amount are considered significant estimates, highly sensitive and depend on assumptions specific to the nature of the Group’s activities including:
| > | outcome of R&D activities |
| > | probability of technical and regulatory success |
| > | market volume, share and pricing (to derive peak year sales) |
| > | amount and timing of projected future cash flows |
| > | sales erosion curves following patent expiry. |
For assets held at fair value less costs to sell, we make appropriate adjustments to reflect market participant assessments.
In 2021, the Group recorded impairment charges of $
Impairment charges recorded against products in development, based on fair value less costs to sell, totalled $
In 2020, the Group recorded impairment charges of $
In 2019, the Group recorded impairment charges of $
The Group has performed an assessment on assets which have had impairments recorded in previous periods to determine if any reversals of impairments were required. Impairment reversals of $
Sensitivities
When launched products, such as the ones detailed above, are partially impaired, the carrying values of these assets in future periods are particularly sensitive to changes in forecast assumptions, including those assumptions set out above, as the asset is impaired down to its recoverable amount.
Were the useful economic lives to be adjusted to reduce them all by one year, the net book value would be reduced by $
Significant assets
| Carrying value |
| Remaining amortisation |
| |
$m | period |
| |||
C5 franchise (Soliris/Ultomiris) intangible assets arising from the acquisition of Alexion |
| | |||
Intangible assets arising from the acquisition of Acerta Pharma | | ||||
Strensiq, Kanuma and Andexxa intangible assets arising from the acquisition of Alexion | | ||||
Intangible asset products in development arising from the acquisition of Alexion1 | | Not amortised | |||
Intangible assets arising from the acquisition of ZS Pharma |
| | |||
Enhertu intangible assets acquired from Daiichi Sankyo | | ||||
Other intangible assets (DS-1062) acquired from Daiichi Sankyo1 |
| | Not amortised | ||
Farxiga/Forxiga intangible assets acquired from BMS |
| | |||
Intangible assets arising from the restructuring of a historical joint venture with MSD |
| | |||
Intangible assets arising from the acquisition of Pearl Therapeutics |
| | |||
RSV franchise assets arising from the acquisition of MedImmune |
| | |||
Monalizumab intangible assets acquired from Innate Pharma1 |
| | Not amortised |
| 1 | Assets in development are not amortised but are tested annually for impairment. |
The acquisition of intangible assets relating to DS-1062 in 2020 was assessed under the optional concentration test in IFRS 3 and was determined to be an asset acquisition, as substantially all of the value of the gross assets acquired was concentrated in a single asset.
In assessing whether the intangible assets and associated processes acquired from Daiichi Sankyo in 2019 were a business, we determined that they were not at a stage of readiness to be able to obtain regulatory approval and manufacture and commercialise at scale. The transaction was treated as an asset acquisition.
11 Investments in associates and joint ventures
F-31
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
At 1 January |
| |
| |
| | |
Additions |
| |
| |
| | |
Share of after tax losses |
| ( |
| ( |
| ( | |
Exchange and other adjustments |
| |
| – |
| | |
At 31 December |
| |
| |
| |
On 29 January 2021, AstraZeneca entered into an agreement with IHP Holdings Limited to create and run an online platform (iHospital) offering consultations with physicians, repeat prescriptions and e-pharmacy in China. The agreement resulted in the formation of a new entity, IHP HK Holdings Limited. AstraZeneca contributed $
On 1 December 2020, AstraZeneca and China International Capital Corporation (CICC) entered into an agreement to set up a Global Healthcare Industrial Fund to drive healthcare system innovation by leveraging local capital and accelerating China-related innovation incubation. The agreement resulted in the formation of a new entity, Wuxi AstraZeneca-CICC Venture Capital Partnership (Limited Partnership). AstraZeneca holds a
On 23 September 2021, AstraZeneca entered into an agreement with VaxEquity Limited to collaborate and develop self-amplifying RNA technology with the aim of generating treatments for target diseases. AstraZeneca has contributed $
On 23 February 2018, AstraZeneca entered into an agreement with a consortium of investors to form a new, US-domiciled standalone company called Viela Bio. This agreement was to divest a number of assets in MedImmune’s non-core inflammation and autoimmunity portfolio to Viela Bio, including MEDI-551, which is an advanced Phase IIb/III asset, and a number of other clinical and pre-clinical assets. AstraZeneca contributed $
On 27 November 2017, AstraZeneca entered into a joint venture agreement with Chinese Future Industry Investment Fund (FIIF), to discover, develop and commercialise potential new medicines to help address unmet medical needs globally, and to bring innovative new medicines to patients in China more quickly. The agreement resulted in the formation of a joint venture entity based in China, Dizal (Jiangsu) Pharmaceutical Co., Limited (Dizal). AstraZeneca contributed $
On 1 December 2015, AstraZeneca entered into a joint venture agreement with Fujifilm Kyowa Kirin Biologics Co., Ltd. to develop a biosimilar using the combined capabilities of the two parties. The agreement resulted in the formation of a joint venture entity based in the UK, Centus Biotherapeutics Limited (Centus). Since its establishment, AstraZeneca has contributed $
On 30 April 2014, AstraZeneca entered into a joint venture agreement with Samsung Biologics Co., Ltd. to develop a biosimilar using the combined capabilities of the two parties. The agreement resulted in the formation of a joint venture entity based in the UK, Archigen Biotech Limited (Archigen). Since its establishment, AstraZeneca has contributed $
All investments are accounted for using the equity method. At 31 December 2021, unrecognised losses in associates and joint ventures totalled $
Aggregated summarised financial information for the associate and joint venture entities is set out below:
| 2021 |
| 2020 |
| 2019 | ||
$m | $m | $m | |||||
Non-current assets |
| |
| |
| | |
Current assets |
| |
| |
| | |
Total liabilities |
| ( |
| ( |
| ( | |
Net assets |
| |
| |
| | |
Amount attributable to AstraZeneca |
| |
| |
| | |
Exchange adjustments |
| |
| |
| ( | |
Carrying value of investments in associates and joint ventures |
| |
| |
| |
12 Other investments
F-32
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Non-current investments |
|
|
|
|
|
| |
Equity securities at fair value through Other comprehensive income | | | | ||||
Fixed income securities at fair value through profit and loss | – | – | | ||||
Total |
| |
| |
| | |
Current investments |
|
|
| ||||
Fixed income securities at fair value through profit and loss | | | | ||||
Fixed deposits |
| |
| |
| | |
Total |
| |
| |
| |
Other investments held at fair value through Other comprehensive income include equity securities which are not held for trading and which the Group has irrevocably elected at initial recognition to recognise in this category. Other investments held at fair value through profit and loss comprise fixed income securities that the Group holds to sell.
The fair value of listed investments is based on year end quoted market prices. Fixed deposits are held at amortised cost with carrying value being a reasonable approximation of fair value given their short-term nature.
Fair value hierarchy
The table below analyses equity securities and bonds, contained within Other investments and carried at fair value, by valuation method. The different levels have been defined as follows:
| > | Level 1: quoted prices (unadjusted) in active markets for identical assets or liabilities |
| > | Level 2: inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly (i.e. as prices) or indirectly (i.e. derived from prices) |
| > | Level 3: inputs for the asset or liability that are not based on observable market data (unobservable inputs). |
| 2021 |
| 2021 | 2020 |
| 2020 |
| 2019 |
| 2019 |
| ||
FVPL | FVOCI | FVPL | FVOCI | FVPL | FVOCI | ||||||||
$m | $m | $m | $m | $m | $m | ||||||||
Level 1 |
| | | | | |
| |
| ||||
Level 2 |
| – | – | – | – | – |
| – |
| ||||
Level 3 |
| – | | – | | – |
| |
| ||||
Total |
| | | | | |
| |
|
During 2020, AstraZeneca sold a proportion of its equity portfolio receiving consideration of $
Equity securities that are analysed at Level 3 include investments in private biotech companies. In the absence of specific market data, these unlisted investments are held at fair value based on the cost of investment and adjusting as necessary for impairments and revaluations on new funding rounds, which approximates to fair value. Movements in Level 3 investments are detailed below:
|
| 2021 |
| 2020 |
| 2019 |
| ||
FVOCI | FVOCI | FVOCI | |||||||
$m | $m | $m |
| ||||||
At 1 January |
|
| |
| |
| | ||
Additions |
|
| |
| |
| | ||
Revaluations |
|
| – |
| |
| | ||
Net transfers (out)/in |
|
| ( |
| ( |
| | ||
Disposals |
|
| – |
| ( |
| ( | ||
Impairments and exchange adjustments |
|
| ( |
| |
| | ||
At 31 December |
|
| |
| |
| |
Assets are transferred in or out of Level 3 on the date of the event or change in circumstances that caused the transfer.
13 Derivative financial instruments
| Non-current |
| Current |
| Current |
| Non-current |
|
| ||
assets | assets | liabilities | liabilities | Total |
| ||||||
$m | $m | $m | $m | $m |
| ||||||
Interest rate swaps related to instruments designated at fair value through profit and loss |
| | – | – | – | | |||||
Cross currency swaps designated in a net investment hedge |
| | – | – | ( | | |||||
Cross currency swaps designated in a cash flow hedge | | – | – | ( | ( | ||||||
Cross currency swaps designated in a fair value hedge1 |
| | – | – | – | | |||||
Other derivatives |
| – | | ( | – | – | |||||
31 December 2019 |
| | | ( | ( | |
F-33
| Non-current |
| Current |
| Current |
| Non-current |
| |||
assets | assets | liabilities | liabilities | Total | |||||||
$m | $m | $m | $m | $m | |||||||
Interest rate swaps related to instruments designated at fair value through profit and loss |
| | – | – | – | | |||||
Cross currency swaps designated in a net investment hedge |
| | – | – | ( | | |||||
Cross currency swaps designated in a cash flow hedge |
| | | – | – | | |||||
Cross currency swaps designated in a fair value hedge1 | – | | – | – | | ||||||
Forward FX designated in a cash flow hedge2 | – | | ( | – | | ||||||
Other derivatives |
| – | | ( | – | | |||||
31 December 2020 |
| | | ( | ( | |
| Non-current |
| Current |
| Current |
| Non-current |
| |||
assets | assets | liabilities | liabilities | Total | |||||||
$m | $m | $m | $m | $m | |||||||
Interest rate swaps related to instruments designated at fair value through profit and loss |
| | – | – | – | | |||||
Cross currency swaps designated in a net investment hedge |
| | – | – | ( | | |||||
Cross currency swaps designated in a cash flow hedge |
| – | – | – | ( | ( | |||||
Forward FX designated in a cash flow hedge2 | – | | – | – | | ||||||
Other derivatives |
| | | ( | – | | |||||
31 December 2021 |
| | | ( | ( | |
| 1 | Cross currency swaps designated in a fair value hedge refers to a cross currency interest rate swap that hedges a designated euro |
| 2 | Forward FX designated in a cash flow hedge relates to contracts hedging anticipated CNY, EUR, GBP, JPY and SEK transactions occurring in the quarter immediately after the balance sheet date. |
All derivatives are held at fair value and fall within Level 2 of the fair value hierarchy as defined in Note 12, except for an equity warrant which falls within Level 3 (valued at $
The fair value of interest rate swaps and cross currency swaps is estimated using appropriate zero coupon curve valuation techniques to discount future contractual cash flows based on rates at the current year end.
The fair value of forward foreign exchange contracts and currency options are estimated by cash flow accounting models using appropriate yield curves based on market forward foreign exchange rates at the year end. The majority of forward foreign exchange contracts for existing transactions had maturities of less than one month from year end.
The interest rates used to discount future cash flows for fair value adjustments, where applicable, are based on market swap curves at the reporting date, and were as follows:
| 2021 |
| 2020 |
| 2019 | |||||||||||
Derivatives |
| ( | % | to | | % | ( | % | to | | % | ( | % | to | | % |
14 Non-current other receivables
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Prepayments |
| |
| |
| | |
Accrued income |
| |
| |
| | |
Other receivables |
| |
| |
| | |
Non-current other receivables |
| |
| |
| |
Prepayments include $
15 Inventories
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Raw materials and consumables |
| |
| |
| | |
Inventories in process |
| |
| |
| | |
Finished goods and goods for resale |
| |
| |
| | |
Inventories |
| |
| |
| |
The Group recognised $
Inventory write-offs in the year amounted to $
16 Current trade and other receivables
F-34
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Amounts due within one year |
|
|
|
|
|
| |
Trade receivables |
| |
| |
| | |
Less: Amounts provided for doubtful debts (Note 28) |
| ( |
| ( |
| ( | |
| |
| |
| | ||
Other receivables |
| |
| |
| | |
Prepayments | | | | ||||
Government grants receivable | – | | – | ||||
Accrued income |
| |
| |
| | |
Trade and other receivables |
| |
| |
| |
Trade receivables includes $
All other financial assets included within current Trade and other receivables are held at amortised cost with carrying value being a reasonable approximation of fair value.
17 Cash and cash equivalents
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Cash at bank and in hand |
| |
| |
| | |
Short-term deposits |
| |
| |
| | |
Cash and cash equivalents |
| |
| |
| | |
Unsecured bank overdrafts |
| ( |
| ( |
| ( | |
Cash and cash equivalents in the cash flow statement |
| |
| |
| |
The Group holds $
AstraZeneca invests in constant net asset value funds and low volatility net asset value funds with same day access for subscription and redemption. These investments fail the ‘solely payments of principal and interest’ test criteria under IFRS 9. They are therefore measured at fair value through profit and loss, although the fair value will be materially the same as amortised cost.
Non-cash and other movements, within operating activities in the Consolidated Statement of Cash Flows, includes:
| 2021 |
| 2020 |
| 2019 | ||
$m | $m | $m | |||||
Changes in fair value of put option (Acerta Pharma) |
| – |
| – |
| | |
Share-based payments charge for the period |
| |
| |
| | |
Settlement of share plan awards | ( | ( | ( | ||||
Pension contributions | ( | ( | ( | ||||
Pension charges recorded in operating profit | | | | ||||
Long-term provision charges recorded in operating profit | | | | ||||
Non-cash intangible additions | – | ( | – | ||||
Foreign exchange and other | ( | ( | ( | ||||
Total operating activities non-cash and other movements |
| |
| ( |
| |
18 Assets held for sale
Assets held for sale of $
In 2019, Assets held for sale comprised tangible assets relating to the Boulder Manufacturing Centre, which was subsequently sold in May 2020.
19 Interest-bearing loans and borrowings
F-35
|
|
| Repayment |
| 2021 |
| 2020 |
| 2019 |
| |
dates | $m | $m | $m |
| |||||||
Current liabilities |
|
| |||||||||
Bank overdrafts |
|
|
| On demand |
| |
| |
| | |
Other short-term borrowings excluding overdrafts | | | | ||||||||
Bank collateral | | | | ||||||||
Lease liabilities |
|
|
| |
| |
| | |||
US dollars | 2020 | – | – | | |||||||
euros | 2021 | – | | – | |||||||
euros | 2021 | – | | – | |||||||
Floating rate notes | US dollars | 2022 | | – | – | ||||||
US dollars | 2022 | | – | – | |||||||
Other loans (including commercial paper) |
|
|
| Within one year |
| |
| |
| – | |
Total |
|
|
| |
| |
| | |||
Non-current liabilities |
|
| |||||||||
Lease liabilities | | | | ||||||||
| euros |
| 2021 |
| – |
| – |
| | ||
| euros |
| 2021 |
| – |
| – |
| | ||
Floating rate notes | US dollars | 2022 | – | | | ||||||
US dollars | 2022 | – | | | |||||||
US dollars | 2023 | | – | – | |||||||
2023 Floating bank loan |
| US dollars |
| 2023 |
| |
| – |
| – | |
Floating rate notes | US dollars | 2023 | | | | ||||||
US dollars | 2023 | | | | |||||||
US dollars | 2023 | | | | |||||||
euros | 2024 | | | | |||||||
US dollars | 2024 | | – | – | |||||||
2024 Floating bank loan |
| US dollars |
| 2024 |
| |
| – |
| – | |
| US dollars |
| 2025 |
| |
| |
| | ||
US dollars | 2026 | | | – | |||||||
US dollars | 2026 | | – | – | |||||||
US dollars | 2027 | | | | |||||||
| euros |
| 2028 |
| |
| |
| | ||
US dollars | 2028 | | – | – | |||||||
US dollars | 2029 | | | | |||||||
euros | 2029 | | – | – | |||||||
US dollars | 2030 | | | – | |||||||
US dollars | 2031 | | – | – | |||||||
| pounds sterling |
| 2031 |
| |
| |
| | ||
| US dollars |
| 2037 |
| |
| |
| | ||
| US dollars |
| 2042 |
| |
| |
| | ||
| US dollars |
| 2045 |
| |
| |
| | ||
US dollars | 2048 | | | | |||||||
US dollars | 2050 | | | – | |||||||
US dollars | 2051 | | – | – | |||||||
Other loans |
| US dollars |
| |
| |
| | |||
Total |
|
|
| |
| |
| | |||
Total interest-bearing loans and borrowings1, 2 |
|
|
| |
| |
| |
| 1 | All loans and borrowings above are unsecured apart from $ |
| 2 | The $ |
F-36
Total | Total | Total | |||||||||||
loans and | loans and | loans and | |||||||||||
borrowings | borrowings | borrowings | |||||||||||
2021 | 2020 | 2019 | |||||||||||
$m | $m | $m | |||||||||||
At 1 January |
|
|
|
| | | | ||||||
Adoption of new accounting standards – Lease liabilities | – | – | | ||||||||||
Changes from financing cash flows |
|
|
|
|
|
| |||||||
Issue of loans and borrowings | | | | ||||||||||
Repayment of loans and borrowings | ( | ( | ( | ||||||||||
Movement in short-term borrowings | ( | | ( | ||||||||||
Repayment of obligations under leases | ( | ( | ( | ||||||||||
Total changes in cash flows arising on financing activities from borrowings | | | ( | ||||||||||
Movement in overdrafts | | | ( | ||||||||||
New lease liabilities | | | | ||||||||||
Additions through business combinations | | – | – | ||||||||||
Exchange | ( | | ( | ||||||||||
Other movements |
|
| | | ( | ||||||||
At 31 December |
|
|
|
| | | |
Set out below is a comparison by category of carrying values and fair values of all the Group’s interest-bearing loans and borrowings:
| Instruments in a |
| Instruments |
| Instruments |
|
| Total |
|
| |||
fair value hedge | designated | designated in | Amortised | carrying | Fair |
| |||||||
relationship | 1 | at fair value | 2 | cash flow hedge | cost | value | value |
| |||||
$m | $m | $m | $m | $m | $m |
| |||||||
2019 |
|
|
|
|
|
|
|
|
|
|
|
| |
Overdrafts |
| – | – | – | | | | ||||||
Lease liabilities due within one year | – | – | – | | | | |||||||
Lease liabilities due after more than one year | – | – | – | | | | |||||||
Loans due within one year |
| – | – | – | | | | ||||||
Loans due after more than one year |
| | | | | | | ||||||
Total at 31 December 2019 |
| | | | | | | ||||||
2020 |
|
|
|
|
|
|
|
|
|
|
|
| |
Overdrafts |
| – | – | – | | | | ||||||
Lease liabilities due within one year | – | – | – | | | | |||||||
Lease liabilities due after more than one year |
| – | – | – | | | | ||||||
Loans due within one year |
| | – | | | | | ||||||
Loans due after more than one year |
| – | | | | | | ||||||
Total at 31 December 2020 |
| | | | | | | ||||||
2021 |
|
|
|
|
|
|
|
|
|
|
|
| |
Overdrafts |
| – | – | – | | | | ||||||
Lease liabilities due within one year |
| – | – | – | | | | ||||||
Lease liabilities due after more than one year | – | – | – | | | | |||||||
Loans due within one year |
| – | – | – | | | | ||||||
Loans due after more than one year |
| – | | | | | | ||||||
Total at 31 December 2021 |
| – | | | | | |
| 1 | Instruments designated as hedged items in a fair value hedge relationship relate to a designated euro |
| 2 | Instruments designated at fair value through profit or loss include the US dollar |
The fair value of fixed-rate publicly traded debt is based on year end quoted market prices; the fair value of floating rate debt is nominal value, as mark-to-market differences would be minimal given the frequency of resets. The carrying value of loans designated at fair value through profit or loss is the fair value; this falls within the Level 1 valuation method as defined in Note 12. For loans designated in a fair value hedge relationship, carrying value is initially measured at fair value and remeasured for fair value changes in respect of the hedged risk at each reporting date. All other loans are held at amortised cost. Fair values, as disclosed in the table above, are all determined using the Level 1 valuation method as defined in Note 12, with the exception of overdrafts and lease liabilities, where fair value approximates to carrying values.
During the year, changes to credit risk caused minimal changes to the fair value of bonds designated at fair value through profit or loss. A gain of $
The interest rates used to discount future cash flows for fair value adjustments, where applicable, are based on market swap curves at the reporting date, and were as follows:
| 2021 |
| 2020 |
| 2019 |
| ||||||||||
Loans and borrowings |
| | % | to | | % | ( | % | to | | % | ( | % | to | | % |
20 Trade and other payables
F-37
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Current liabilities |
|
|
|
|
|
| |
Trade payables |
| |
| |
| | |
Value-added and payroll taxes and social security |
| |
| |
| | |
Rebates, chargebacks, returns and other revenue accruals |
| |
| |
| | |
Clinical trial accruals |
| |
| |
| | |
Other accruals | | | | ||||
Collaboration Revenue contract liabilities | | | | ||||
Vaccine contract liabilities | | | – | ||||
Deferred government grant income | | | – | ||||
Contingent consideration |
| |
| |
| | |
Acerta Pharma share purchase liability (Note 26) | | – | – | ||||
Other payables |
| |
| |
| | |
Total |
| |
| |
| | |
Non-current liabilities |
|
|
| ||||
Accruals |
| |
| |
| | |
Collaboration Revenue contract liabilities | | | | ||||
Contingent consideration |
| |
| |
| | |
Acerta Pharma share purchase/put option liability (Note 26) | | | | ||||
Other payables |
| |
| |
| | |
Total |
| |
| |
| |
Included within Rebates, chargebacks, returns and other revenue accruals are contract liabilities of $
Trade payables includes $
Vaccine contract liabilities relate to amounts received from customers, primarily government bodies, in advance of supply of product. Substantially all of the Vaccine contract liabilities are expected to be recognised as revenue during the next financial year. The revenue recognised in the year related to Vaccine contract liabilities held at the beginning of the year was $
Deferred government grant income relates to government grants received or receivable but for which the related expenses have not been incurred.
Included within current Other payables are liabilities to Daiichi Sankyo totalling $nil (2020: $
In November 2020, Calquence received marketing approval in the EU, which removed all remaining conditionality in respect of the Acerta Pharma put and call options regarding the non-controlling interest; the option was exercised in April 2021 (see Note 26). Based on the latest assessment of the expected timing and amount of the Acerta Pharma put option redemption,
With the exception of Contingent consideration payables of $
Contingent consideration
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
At 1 January |
| |
| |
| | |
Settlements |
| ( |
| ( |
| ( | |
Revaluations |
| |
| ( |
| ( | |
Reclassification to Other payables | ( | – | – | ||||
Discount unwind (Note 3) |
| |
| |
| | |
At 31 December |
| |
| |
| |
Contingent consideration arising from business combinations is fair valued using decision-tree analysis, with key inputs including the probability of success, consideration of potential delays and the expected levels of future revenues.
F-38
Revaluations of Contingent consideration are recognised in Selling, general and administrative expense and include an increase of $
The discount rate used for the Contingent consideration balances range from
Management has identified that reasonably possible changes in certain key assumptions, including the likelihood of achieving successful trial results, obtaining regulatory approval, the projected market share of the therapy area and expected pricing for launched products, may cause the calculated fair value of the above contingent consideration to vary materially in future years.
The contingent consideration balance relating to BMS’s share of Global Diabetes Alliance of $
The maximum development and sales milestones payable under outstanding Contingent consideration arrangements arising on business combinations are as follows:
|
| Nature of |
| Maximum future milestones |
| ||
Acquisitions | Year | contingent consideration | $m |
| |||
Spirogen |
| 2013 |
| Milestones |
| | |
Amplimmune |
| 2013 |
| Milestones |
| | |
Almirall1 | 2014 | Milestones and royalties | |
| 1 | These contingent consideration liabilities have been designated as the hedge instrument in a net investment hedge of foreign currency risk arising on the Group’s underlying US dollar net investments held in non-US dollar denominated subsidiaries. Exchange differences on the retranslation of the contingent consideration liability are recognised in Other comprehensive income to the extent that the hedge is effective. Any ineffectiveness is taken to profit. |
The amount of royalties payable under the arrangements is inherently uncertain and difficult to predict, given the direct link to future sales and the range of outcomes. The maximum amount of royalties payable in each year is with reference to net sales.
21 Provisions
|
|
| Employee |
|
| Other |
|
| |||||
Severance | Environmental | benefits | Legal | provisions | Total |
| |||||||
$m | $m | $m | $m | $m | $m |
| |||||||
At 1 January 2019 |
| | | | | | | ||||||
Charge for year |
| | | | | | | ||||||
Cash paid |
| ( | ( | ( | ( | ( | ( | ||||||
Reversals |
| ( | ( | – | ( | ( | ( | ||||||
Exchange and other movements |
| | | | | | | ||||||
At 31 December 2019 |
| | | | | | | ||||||
Transfers in | – | – | – | – | | | |||||||
Charge for year |
| | | | | | | ||||||
Cash paid |
| ( | ( | ( | ( | ( | ( | ||||||
Reversals |
| ( | – | ( | ( | ( | ( | ||||||
Exchange and other movements |
| | – | | ( | | | ||||||
At 31 December 2020 |
| | | | | | | ||||||
Additions through business combinations (Note 27) | – | – | | | | | |||||||
Charge for year |
| | | | | | | ||||||
Cash paid |
| ( | ( | ( | ( | ( | ( | ||||||
Reversals |
| ( | – | – | ( | ( | ( | ||||||
Exchange and other movements |
| ( | ( | | ( | ( | | ||||||
At 31 December 2021 |
| | | | | | |
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Due within one year |
| |
| |
| | |
Due after more than one year |
| |
| |
| | |
Total |
| |
| |
| |
Severance provisions arise predominantly in connection with global restructuring initiatives which involve rationalisation of the global supply chain, the sales and marketing organisation, IT and business support infrastructure, and R&D.
During 2021, in conjunction with the acquisition of Alexion, the enlarged Group has initiated a comprehensive Post Alexion Acquisition Group Review, aimed at integrating systems, structure and processes, optimising the global footprint and prioritising resource allocations and investments. The Group has also continued to progress other legacy restructuring programmes, including the Global Post-Pandemic New Ways of Working programme that was initiated in 2020 in response to the changing business environment, accelerated by the COVID-19 pandemic.
Employee costs in connection with the initiatives are recognised in severance provisions when a detailed formal plan has been communicated to those employees affected. Final severance costs are often subject to the completion of the requisite consultations on the areas impacted, with the majority of the cost expected to be paid within one year. AstraZeneca endeavours to support employees affected by restructuring initiatives to seek alternative roles within the organisation. Where the employee is successful, any severance provisions will be released.
Details of the Environmental and Legal provisions totalling $
F-39
The majority of Employee benefit provisions relate to Executive Deferred Compensation Plans.
Other provisions comprise amounts relating to specific contractual or constructive obligations and disputes. Included within Other provisions are amounts associated with long-standing product liability settlements that arose prior to the merger of Astra and Zeneca, which given the nature of the provision, the amounts are expected to be settled over many years. Also included in Other provisions is an amount of $
No provision has been released or applied for any purpose other than that for which it was established.
22 Post-retirement and other defined benefit schemes
Background
This section predominantly covers defined benefit arrangements like post retirement pension and medical plans which make up the vast bulk of the Group’s liabilities. However, it also incorporates other benefits which fall under IAS 19 rules and which require an actuarial valuation, including but not limited to: Lump Sum plans, Long Service Awards and defined contribution pension plans which have some defined benefit characteristics (e.g. a minimum guaranteed level of benefit).
The Group and most of its subsidiaries offer retirement plans which cover the majority of employees. The Group’s policy is to provide defined contribution (DC) orientated pension provision to its employees unless otherwise compelled by local regulation. As a result, many of these retirement plans are DC, where the Group contribution and resulting charge is fixed at a set level or is a set percentage of employees’ pay. However, several plans, mainly in the UK, the US and Sweden, are defined benefit (DB), where benefits are based on employees’ length of service and linked to their salary. The major DB plans are largely legacy arrangements as they have been closed to new entrants since 2000, apart from the collectively bargained Swedish plan (which is still open to employees born before 1979). During 2010, following consultation with its UK employees’ representatives, the Group introduced a freeze on pensionable pay at 30 June 2010 levels for DB members of the UK Pension Fund. The number of active members in the Fund continues to decline and is now
The major DB plans are funded through separate, fiduciary-administered assets. The cash funding of the plans, which may from time to time involve special Group payments, is designed, in consultation with independent qualified actuaries, to ensure that the assets are sufficient to meet future obligations as and when they fall due. The funding level is monitored by the Group and local fiduciaries, who take into account the strength of the Group’s covenant, local regulation, cash flows, and the solvency and maturity of the pension scheme.
Financing Principles and Funding Framework
The Group has developed a long-term funding framework to implement these principles. This framework targets either full funding on a low-risk funding measure or buy-out with an external insurer as the pension funds mature, with affordable long-term de-risking of investment strategy along the way. Unless local regulation dictates otherwise, this framework determines the cash contributions payable.
UK
The UK Pension Fund represents approximately
Role of Trustee and Regulation
The UK Pension Fund is governed and administered by a corporate Trustee which is legally separate from the Group. The Trustee Directors are comprised of representatives appointed by both the employer and employees and include an independent professional Trustee Director. The Trustee Directors are required by law to act in the interest of all relevant beneficiaries and are responsible in particular for investment strategy and the day-to-day administration of the benefits. They are also responsible for jointly agreeing with the employer the level of contributions due to the UK Pension Fund.
The UK pensions market is regulated by The Pensions Regulator whose statutory objectives and regulatory powers are described on its website, www.thepensionsregulator.gov.uk.
The Pension Scheme Act 2021 became effective in the UK from 1 October 2021. A section of this Act places additional legal requirements on companies who sponsor UK defined benefit pension schemes, with a focus on the ongoing security of these benefits. The Group has considered the implications of the Act and developed a framework to ensure it meets its responsibilities on an ongoing basis.
There have been two UK High Court Rulings relating to Guaranteed Minimum Pensions (GMP) equalisation in 2018 and 2020. Following the publication of guidance around implementation in 2021, the Trustee, with input from the Group, has begun the process of equalising benefits, with implementation likely to be in 2023. An estimate of the impact of these changes has already been recognised in 2018 and 2020.
Funding requirements
UK legislation requires that DB pension schemes are funded prudently. On a triennial basis, the Trustee and the Group must agree on a set of assumptions used to value the liabilities as a part of an actuarial valuation. Together with the asset valuation, this facilitates the calculation of a funding level and of the contributions required (if any) to ensure the UK Pension Fund is fully funded over an appropriate time period and on a suitably prudent measure. The technical provisions assumptions used to value the liabilities for the triennial actuarial valuation are usually set more prudently than the assumptions used to prepare an accounting valuation of the liabilities, which are set under IAS 19 rules to be a ‘best estimate’.
The last full actuarial valuation of the UK Pension Fund was carried out by a qualified actuary as at 31 March 2019. It was finalised in June 2020 and in early 2021, the Pensions Regulator acknowledged the outcome and no issues were raised. The funding assumptions used in this actuarial valuation were set out in the Group’s prior year report. The next actuarial valuation is due to take place as at 31 March 2022, with a likely timescale for completion in early to mid-2023.
Aspects of the triennial actuarial valuation are governed by a long-term funding agreement, effective since October 2016 and which sets out a path to full funding on a low-risk measure. Under this agreement, if a deficit exists, the Group will grant a charge in favour of the Trustee over land and buildings on the Cambridge Biomedical Campus, effective upon practical completion of the site, or from 30 September 2022 (whichever is earlier).
F-40
This charge is not currently in force. When effective, the charge would only crystallise in the event of the Group’s insolvency. This charge will provide long-term security in respect of future UK Pension Fund contributions and will be worth up to £
In relation to deficit recovery contributions, a lump sum contribution of £
During 2017, the Group provided a letter of credit to the Trustee, to underwrite the deferral of an additional deficit recovery contribution of approximately £
Under the governing documentation of the UK Pension Fund, any future surplus in the Fund would be returnable to the Group by refund assuming gradual settlement of the liabilities over the lifetime of the Fund. In particular, the Trustee has no unilateral right to wind up the Fund without Company consent nor does it have the power to unilaterally use surplus to augment benefits prior to wind-up. As such, there are
On current bases, it is expected that ongoing contributions (excluding those in respect of past service deficit contributions) during the year ending 31st December 2022 for the UK scheme will be approximately $
United States and Sweden
The US and Sweden plans account for
The US defined benefit pension plans were actuarially revalued at 31 December 2021, when plan obligations were $
The Swedish defined benefit pension plans were actuarially valued at 31 December 2021, when plan obligations were estimated to amount to $
On current bases, it is expected that ongoing contributions (excluding those in respect of past service deficit contributions) during the year ending 31 December 2022 for the United States and Sweden will be approximately $
Other defined benefit plans
The Group provides benefit plans other than pensions which have to be reported under IAS 19. These include Lump Sum plans, Long Service Awards and defined contribution pension plans which have a guaranteed minimum benefit. However, the largest category of these ‘other’ non-pension plans are healthcare benefits.
In the US, and to a lesser extent in certain other countries, the Group’s employment practices include the provision of healthcare and life assurance benefits for eligible retired employees. As at 31 December 2021, some
In the US, there was a change to the level of benefit provision for members aged
The cost of post-retirement benefits other than pensions for the Group in 2021 was $
Financial assumptions
Qualified independent actuaries have updated the actuarial valuations under IAS 19 for the major defined benefit schemes operated by the Group to 31 December 2021. The assumptions used may not necessarily be borne out in practice, due to the inherent financial and demographic uncertainty associated with making long-term projections. These assumptions reflect the changes which have the most material impact on the results of the Group and were as follows:
2020 | |||||||||
UK |
| US | Sweden | Rest of Group4 | |||||
Inflation assumption | | % | – | | % | | % | ||
Rate of increase in salaries | – | 1 | – | | % | | % | ||
Rate of increase in pensions in payment | | % | – | | % | | % | ||
Discount rate – defined benefit obligation | | % | | % | | % | | % | |
Discount rate – interest cost | | % | | % | | % | | % | |
Discount rate – service cost | | % | | % | | % | | % | |
2021 | |||||||||
UK |
| US | Sweden | Rest of Group4 | |||||
Inflation assumption | | % | – | | % | | % | ||
Rate of increase in salaries | – | 1 | – | | % | | % | ||
Rate of increase in pensions in payment | | % | – | | % | | % | ||
Discount rate – defined benefit obligation2 | | % | | % | | % | | % | |
Discount rate – interest cost3 | | % | | % | | % | | % | |
Discount rate – service cost3 | | % | n/a | % | | % | | % | |
| 1 | Pensionable pay frozen at 30 June 2010 levels following UK fund changes. |
| 2 | Group defined benefit obligation as at 31 December 2021 calculated using discount rates based on market conditions as at 31 December 2021. |
| 3 | 2021 interest costs and service costs calculated using discount rates based on market conditions as at 31 December 2020. |
| 4 | Rest of Group reflects the assumptions in Germany as these have the most material impact on the Group. |
The weighted average duration of the post-retirement scheme obligations is approximately
F-41
Demographic assumptions
The mortality assumptions are based on country-specific mortality tables. These are compared to actual experience and adjusted where sufficient data are available. Additional allowance for future improvements in life expectancy is included for all major schemes where there is credible data to support a continuing trend.
The table below illustrates life expectancy assumptions at age for male and female members retiring in 2021 and male and female members expected to retire in 2041 (2020: 2020 and 2040 respectively).
Life expectancy assumption for a male member retiring at age 65 |
| Life expectancy assumption for a female member retiring at age 65 |
| ||||||||||||||
Country |
| 2021 |
| 2041 |
| 2020 |
| 2040 |
| 2021 |
| 2041 |
| 2020 |
| 2040 |
|
UK |
|
|
| ||||||||||||||
US |
|
|
| ||||||||||||||
Sweden |
|
|
| ||||||||||||||
In the UK, the Group adopted the CMI 2020 Mortality Projections Model with a
The assumption used for the US plans was updated in 2021 to use the mortality tables (MP-2021) that were published during the year.
Risks associated with the Group’s defined benefit pension schemes
The UK defined benefit plan accounts for
Risk |
| Description |
| Mitigation |
Volatile asset returns | The Defined Benefit Obligation (DBO) is calculated using a discount rate set with reference to AA-rated corporate bond yields; asset returns that differ from the discount rate will create an element of volatility in the solvency ratio. The UK Pension Fund holds a significant proportion of assets (around | In order to mitigate investment risk, the Trustee invests in a suitably diversified range of asset classes, return drivers and investment managers. The investment strategy will evolve to further improve the expected risk/return profile as opportunities arise. The Trustee has hedged approximately | ||
Changes in bond yields | A decrease in corporate bond yields will increase the present value placed on the DBO for accounting purposes. | The interest rate hedge of the UK Pension Fund is implemented via holding gilts and swaps of appropriate duration and set at approximately There are some differences in the bonds and instruments held by the UK Pension Fund to hedge interest rate risk on the statutory and long-term funding basis (gilts and swaps) and the bonds analysed to set the DBO discount rate on an accounting basis (AA corporate bonds). As such, there remains some mismatching risk on an accounting basis should yields on gilts and swaps diverge compared to AA corporate bonds. | ||
Inflation risk | The majority of the DBO is indexed in line with price inflation (mainly inflation as measured by the UK Retail Price Index (RPI) but also for some members a component of pensions is indexed by the UK Consumer Price Index (CPI)) and higher inflation will lead to higher liabilities (although, in most cases, this is capped at an annual increase of | The UK Pension Fund holds RPI index-linked gilts and derivative instruments such as swaps. The inflation hedge of the UK Pension Fund is set at approximately | ||
Life expectancy | The majority of the UK Pension Fund’s obligations are to provide benefits for the life of the member, so increases in life expectancy will result in an increase in the liabilities. | The UK Pension Fund entered into a longevity swap during 2013 which provides hedging against the longevity risk of increasing life expectancy over the next |
Other risks
There are a number of other risks of administering the UK Pension Fund including counterparty risks from using derivatives (mitigated by using a specialist investment manager to oversee a diversified range of counterparties of high standing and ensuring positions are collateralised daily). Furthermore, there are operational risks (such as paying out the wrong benefits) and legislative risks (such as the government increasing the burden on companies through new legislation). These are mitigated so far as possible via the governance structure in place which oversees and administers the pension funds.
The Group’s pension plans in the US and Sweden also manage these key risks, where they are relevant, in a similar way, with the local fiduciary bodies investing in a diversified manner and employing a framework to hedge interest rate risk.
F-42
Local fiduciary boards are aware of Environmental, Social and Governance (ESG) risks as they pertain to investment policy, and where local regulation allows, have policies in place to monitor and manage such risks and comply with local legislation and disclosure requirements.
Assets and obligations of defined benefit schemes
The assets and obligations of the defined benefit schemes operated by the Group at 31 December 2021, as calculated in accordance with IAS 19, are shown below. The fair values of the schemes’ assets are not intended to be realised in the short term and may be subject to significant change before they are realised. The present value of the schemes’ obligations is derived from cash flow projections over long periods and is therefore inherently uncertain.
Scheme assets
2020 | |||||||||||||||||||||||
| UK | US | Sweden |
| Rest of Group |
| Total | ||||||||||||||||
Quoted |
| Unquoted | Quoted | Unquoted | Quoted | Unquoted |
| Quoted |
| Unquoted |
| Quoted |
| Unquoted |
| Total | |||||||
$m | $m | $m | $m | $m | $m | $m | $m | $m | $m | $m | |||||||||||||
Government bonds1 |
| | – | | – | – | – | | – | | – | | |||||||||||
Corporate bonds2 |
| – | – | | – | – | – | | – | | – | | |||||||||||
Derivatives3 |
| – | ( | – | – | – | | | – | | | | |||||||||||
Investment funds: Listed Equities4 |
| – | | | | – | | | | | | | |||||||||||
Investment funds: Absolute Return/Multi Strategy4 |
| | – | | – | | | – | | | | ||||||||||||
Investment funds: Corporate Bonds/Credit4 |
| – | | – | | – | | | | | | | |||||||||||
Cash and cash equivalents |
| | | | – | – | | – | | | | | |||||||||||
Other |
| – | – | – | | – | – | ( | | ( | | | |||||||||||
Total fair value of scheme assets5 |
| | | | | – | | | | | | |
2021 | |||||||||||||||||||||||
| UK | US | Sweden |
| Rest of Group |
| Total | ||||||||||||||||
Quoted |
| Unquoted | Quoted | Unquoted | Quoted | Unquoted |
| Quoted |
| Unquoted |
| Quoted |
| Unquoted |
| Total | |||||||
$m | $m | $m | $m | $m | $m | $m | $m | $m | $m | $m | |||||||||||||
Government bonds1 |
| | – | | – | – | – | | – | | – | | |||||||||||
Corporate bonds2 |
| – | – | | – | – | – | | – | | – | | |||||||||||
Derivatives3 |
| – | ( | | ( | – | | ( | – | | | | |||||||||||
Investment funds: Listed Equities4 |
| – | | – | – | – | | | | | | | |||||||||||
Investment funds: Absolute Return/Multi Strategy4 |
| – | | – | – | – | | | – | | | | |||||||||||
Investment funds: Corporate Bonds/Credit4 |
| – | | – | – | – | | | | | | | |||||||||||
Cash and cash equivalents |
| | | | – | – | | – | | | | | |||||||||||
Other |
| – | – | – | | – | – | | | | | | |||||||||||
Total fair value of scheme assets5 |
| | | | | – | | | | | | |
| 1 | Predominantly developed markets in nature. |
| 2 | Predominantly developed markets in nature and investment grade (AAA-BBB). |
| 3 | Includes interest rate swaps, inflation swaps, longevity swap, equity total return swaps and other contracts. More detail is given in the section Risks associated with the Group’s defined benefit pensions on page 171. Valuations are determined by independent third parties. |
| 4 | Investment Funds are pooled, commingled vehicles, whereby the pension scheme owns units in the fund, alongside other investors. The pension schemes invest in a number of Investment Funds, including Listed Equities (primarily developed markets with some emerging markets), Corporate Bonds/Credit (a range of investment grade and non-investment grade credit) and Absolute Return/Multi Strategy (multi-asset exposure both across and within traditional and alternative asset classes). The price of the funds is set by independent administrators/custodians employed by the investment managers and based on the value of the underlying assets held in the fund. Details of pricing methodology is set out within internal control reports provided for each fund. Prices are updated daily, weekly or monthly depending upon the frequency of the fund’s dealing. |
| 5 | Included in scheme assets is $nil (2020: $ |
Scheme obligations
2020 | ||||||||||
| UK | US | Sweden |
| Rest of Group |
| Total | |||
$m | $m | $m | $m | $m | ||||||
Present value of scheme obligations in respect of: |
| |||||||||
Active membership |
| ( | ( | ( | ( | ( | ||||
Deferred membership |
| ( | ( | ( | ( | ( | ||||
Pensioners |
| ( | ( | ( | ( | ( | ||||
Total value of scheme obligations |
| ( | ( | ( | ( | ( |
2021 | ||||||||||
| UK | US | Sweden |
| Rest of Group |
| Total | |||
$m | $m | $m | $m | $m | ||||||
Present value of scheme obligations in respect of: |
| |||||||||
Active membership |
| ( | ( | ( | ( | ( | ||||
Deferred membership |
| ( | ( | ( | ( | ( | ||||
Pensioners |
| ( | ( | ( | ( | ( | ||||
Total value of scheme obligations |
| ( | ( | ( | ( | ( |
F-43
Net deficit in the scheme
2020 | |||||||||
UK | US | Sweden |
| Rest of Group |
| Total | |||
$m | $m | $m | $m | $m | |||||
Total fair value of scheme assets | | | | | | ||||
Total value of scheme obligations | ( | ( | ( | ( | ( | ||||
Deficit in the scheme as recognised in the | ( | ( | ( | ( | ( |
2021 | |||||||||
UK | US | Sweden |
| Rest of Group |
| Total | |||
$m | $m | $m | $m | $m | |||||
Total fair value of scheme assets | | | | | | ||||
Total value of scheme obligations | ( | ( | ( | ( | ( | ||||
Deficit in the scheme as recognised in the | ( | | ( | ( | ( |
Fair value of scheme assets
2021 | 2020 |
| ||||||||||||||||||
UK | US | Sweden |
| Rest of Group |
| Total |
| UK | US | Sweden |
| Rest of Group |
| Total |
| |||||
$m | $m | $m | $m | $m | $m | $m | $m | $m | $m |
| ||||||||||
At beginning of year | | | | | |
| | | | | | |||||||||
Interest income on scheme assets | | | | | |
| | | | | | |||||||||
Expenses | ( | – | – | – | ( |
| ( | ( | – | ( | ( | |||||||||
Actuarial gains/(losses) | | ( | | | |
| | | | | | |||||||||
Exchange and other adjustments | ( | ( | ( | | ( |
| | – | | | | |||||||||
Employer contributions | | | | | |
| | | | | | |||||||||
Participant contributions | | – | – | | |
| | – | – | | | |||||||||
Benefits paid | ( | ( | ( | ( | ( |
| ( | ( | ( | ( | ( | |||||||||
Scheme assets’ fair value at end of year | | | | | |
| | | | | |
The actual return on the plan assets was a gain of $
Movement in post-retirement scheme obligations
2021 | 2020 | |||||||||||||||||||
UK | US | Sweden |
| Rest of Group |
| Total |
| UK | US | Sweden |
| Rest of Group |
| Total | ||||||
$m | $m | $m | $m | $m | $m | $m | $m | $m | $m | |||||||||||
Present value of obligations in scheme at beginning of year | ( | ( | ( | ( | ( |
| ( | ( | ( | ( | ( | |||||||||
Current service cost | ( | ( | ( | ( | ( |
| ( | ( | ( | ( | ( | |||||||||
Past service (cost)/credit | ( | – | ( | – | ( |
| ( | | ( | ( | | |||||||||
Participant contributions | ( | – | – | ( | ( |
| ( | – | – | ( | ( | |||||||||
Benefits paid | | | | | |
| | | | | | |||||||||
Interest expense on post-retirement scheme obligations | ( | ( | ( | ( | ( |
| ( | ( | ( | ( | ( | |||||||||
Actuarial gains/(losses) | | | ( | | |
| ( | ( | ( | ( | ( | |||||||||
Exchange and other adjustments | | | | | |
| ( | – | ( | ( | ( | |||||||||
Present value of obligations in scheme at end of year | ( | ( | ( | ( | ( |
| ( | ( | ( | ( | ( |
The obligations arise from the following plans:
2021 | 2020 |
| ||||||||||||||||||
UK | US | Sweden |
| Rest of Group |
| Total |
| UK | US | Sweden |
| Rest of Group |
| Total |
| |||||
$m | $m | $m | $m | $m | $m | $m | $m | $m | $m |
| ||||||||||
Funded – pension schemes | ( | ( | ( | ( | ( |
| ( | ( | ( | ( | ( | |||||||||
Funded – post-retirement healthcare | – | ( | – | – | ( |
| – | ( | – | – | ( | |||||||||
Unfunded – pension schemes | – | ( | ( | ( | ( |
| – | ( | – | ( | ( | |||||||||
Unfunded – post-retirement healthcare | ( | – | – | ( | ( |
| ( | – | – | ( | ( | |||||||||
Total | ( | ( | ( | ( | ( |
| ( | ( | ( | ( | ( |
F-44
Consolidated Statement of Comprehensive Income disclosures
The amounts that have been charged to the Consolidated Statement of Comprehensive Income, in respect of defined benefit schemes for the year ended 31 December 2021, are set out below.
2021 | 2020 |
| ||||||||||||||||||
UK | US | Sweden |
| Rest of Group |
| Total |
| UK | US | Sweden |
| Rest of Group |
| Total |
| |||||
$m | $m | $m | $m | $m | $m | $m | $m | $m | $m |
| ||||||||||
Operating profit |
|
|
|
|
|
|
|
|
|
|
| |||||||||
Current service cost | ( | ( | ( | ( | ( |
| ( | ( | ( | ( | ( | |||||||||
Past service (cost)/credit | ( | – | ( | – | ( |
| ( | | ( | ( | | |||||||||
Expenses | ( | – | – | – | ( |
| ( | ( | – | ( | ( | |||||||||
Total (charge)/credit to Operating profit | ( | ( | ( | ( | ( |
| ( | | ( | ( | ( | |||||||||
Finance expense |
| |||||||||||||||||||
Interest income on scheme assets | | | | | |
| | | | | | |||||||||
Interest expense on post-retirement scheme obligations | ( | ( | ( | ( | ( |
| ( | ( | ( | ( | ( | |||||||||
Net interest on post-employment defined benefit plan liabilities | ( | ( | ( | ( | ( |
| ( | ( | ( | ( | ( | |||||||||
(Charge)/credit before taxation | ( | ( | ( | ( | ( |
| ( | | ( | ( | ( | |||||||||
Other comprehensive income |
| |||||||||||||||||||
Difference between the actual return and the expected return on the post-retirement scheme assets | | ( | | | |
| | | | | | |||||||||
Experience (losses)/gains arising on the post-retirement scheme obligations | ( | ( | – | | |
| | ( | ( | ( | ( | |||||||||
Changes in financial assumptions underlying the present value of the post-retirement scheme obligations | | | ( | ( | |
| ( | ( | ( | ( | ( | |||||||||
Changes in demographic assumptions | | ( | – | ( | ( |
| ( | | – | – | ( | |||||||||
Remeasurement of the defined benefit liability | | | | | |
| ( | ( | | ( | ( |
Past service costs include granting early retirement in the UK and Sweden. Past service cost in 2020 includes a credit of $
Total Group pension costs in respect of defined contribution and defined benefit schemes during the year are set out below (see Note 29).
| 2021 |
| 2020 |
| |||
$m | $m |
| |||||
Defined contribution schemes |
| |
| | |||
Defined benefit schemes − current service costs and expenses | | | |||||
Defined benefit schemes − past service credit |
| |
| ( | |||
Pension costs |
| |
| |
Rate sensitivities
The following table shows the US dollar effect of a change in the significant actuarial assumptions used to determine the retirement benefits obligations in our
2021 | 2020 |
| |||||||
| + |
|
| + |
|
| |||
Discount rate |
|
|
|
|
| ||||
UK ($m) |
| | ( |
| | ( | |||
US ($m) |
| | ( |
| | ( | |||
Sweden ($m) |
| | ( |
| | ( | |||
Total ($m) |
| | ( |
| | ( |
2021 | 2020 |
| |||||||
| + |
|
| + |
|
| |||
Inflation rate1 |
|
|
|
|
|
|
|
| |
UK ($m) |
| ( | |
| ( | | |||
US ($m) |
| n/a | n/a |
| n/a | n/a | |||
Sweden ($m) |
| ( | |
| ( | | |||
Total ($m) |
| ( | |
| ( | |
2021 | 2020 |
| |||||||
| + |
|
| + |
|
| |||
Rate of increase in salaries |
|
|
|
|
|
|
|
| |
UK ($m) |
| n/a | n/a |
| n/a | n/a | |||
US ($m) |
| n/a | n/a |
| n/a | n/a | |||
Sweden ($m) |
| ( | |
| ( | | |||
Total ($m) |
| ( | |
| ( | |
F-45
2021 | 2020 | ||||||||
|
|
|
| ||||||
Mortality rate |
|
|
|
|
|
|
|
| |
UK ($m) |
| ( | 2 | | 3 | ( | | ||
US ($m) |
| ( | | ( | | ||||
Sweden ($m) |
| ( | | ( | | ||||
Total ($m) |
| ( | | ( | |
| 1 | Rate of increase in pensions in payment follows inflation. |
| 2 | Of the $ |
| 3 | Of the $ |
The sensitivity to the financial assumptions shown above has been estimated taking into account the approximate duration of the liabilities and the overall profile of the plan membership.
The inflation sensitivity allows for the impact of a change in inflation on salary increases and pension increases (where these assumptions are inflation-linked).
The salary increase sensitivity reflects the impact of an increase of only salary relative to inflation.
The sensitivity to the life expectancy assumption is estimated based on a revised mortality assumption that extends/reduces the current life expectancy by one year for a particular age.
23 Reserves
Retained earnings
The cumulative amount of goodwill written off directly to reserves resulting from acquisitions, net of disposals, amounted to $
At 31 December 2021,
There are no significant statutory or contractual restrictions on the distribution of current profits of subsidiaries; undistributed profits of prior years are, in the main, permanently employed in the businesses of these companies. The undistributed income of AstraZeneca companies overseas might be liable to overseas taxes and/or UK taxation (after allowing for double taxation relief) if they were to be distributed as dividends (see Note 4).
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Cumulative translation differences included within Retained earnings |
|
|
|
|
|
| |
At 1 January |
| ( |
| ( |
| ( | |
Foreign exchange arising on consolidation |
| ( |
| |
| | |
Exchange adjustments on goodwill (recorded against other reserves) |
| ( |
| |
| ( | |
Foreign exchange arising on designated borrowings in net investment hedges1 |
| ( |
| |
| ( | |
Fair value movements on derivatives designated in net investment hedges |
| |
| |
| | |
Net exchange movement in Retained earnings |
| ( |
| |
| ( | |
At 31 December |
| ( |
| ( |
| ( |
| 1 | Foreign exchange arising on designated borrowings in net investment hedges includes $ |
The cumulative gain with respect to costs of hedging is $
The balance remaining in the foreign currency translation reserve from net investment hedging relationships for which hedge accounting no longer applied is a gain of $
Other reserves
The other reserves arose from the cancellation of £
24 Share capital
Allotted, called-up and fully paid |
| ||||||
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Issued Ordinary Shares ($ |
| |
| |
| | |
Redeemable Preference Shares (£ |
| – |
| – |
| – | |
At 31 December |
| |
| |
| | |
The Redeemable Preference Shares carry limited class voting rights and
The Company does not have a limited amount of authorised share capital.
F-46
The movements in the number of Ordinary Shares during the year can be summarised as follows:
No. of shares |
| ||||||
| 2021 |
| 2020 |
| 2019 |
| |
At 1 January |
| |
| |
| | |
Issue of shares (share placing) | – | – | | ||||
Issue of share capital (business combinations) | | – | – | ||||
Issue of shares (share schemes) |
| |
| |
| | |
At 31 December |
| |
| |
| |
Share issues
Issue of share capital (business combinations) represents share capital issued as part of the acquisition of Alexion (see Note 27).
Share repurchases
Shares held by subsidiaries
25 Dividends to shareholders
| 2021 |
| 2020 |
| 2019 |
| 2021 |
| 2020 |
| 2019 |
| ||||
Per share | Per share | Per share | $m | $m | $m |
| ||||||||||
Second interim (March 2021) | $ | $ | $ |
| |
| |
| | |||||||
First interim (September 2021) | $ | $ | $ |
| |
| |
| | |||||||
Total | $ | $ | $ |
| |
| |
| |
The Company has exercised its authority in accordance with the provisions set out in the Company’s Articles of Association, that the balance of unclaimed dividends outstanding past
The 2020 second interim dividend of $
Reconciliation of dividends charged to equity to cash flow statement:
2021 | 2020 | 2019 | ||||||
|
| $m |
| $m |
| $m | ||
Dividends charged to equity |
|
| |
| |
| | |
Exchange losses on payment of dividend | | | | |||||
Hedge contracts relating to payment of dividends (cash flow statement) |
|
| ( | ( | | |||
Dividends paid (cash flow statement) |
|
| | | |
26 Non-controlling interests
The Group Financial Statements at 31 December 2021 reflect equity of $
In addition to the non-controlling interests in AstraZeneca Pharma India Limited, P.T. AstraZeneca Indonesia and Beijing Falikang Pharmaceutical (China) Co. Limited, the Group Financial Statements at 31 December 2021 also reflect equity of $
In February 2016, AstraZeneca acquired a
The following summarised financial information, for Acerta Pharma and its subsidiaries, prior to full consolidation in 2020, is presented on a standalone basis since the acquisition date, and before the impact of Group-related adjustments, some of which are incorporated into the calculation of the loss attributable to the non-controlling interests:
|
| 2019 |
| ||||
$m |
| ||||||
Total Revenue |
| – | |||||
Loss after tax |
| ( | |||||
Other comprehensive income |
| – | |||||
Total comprehensive loss |
| ( |
F-47
| 2019 |
| |||||
$m |
| ||||||
Non-current assets |
| | |||||
Current assets |
| | |||||
Total assets |
| | |||||
Current liabilities |
| ( | |||||
Non-current liabilities | ( | ||||||
Total liabilities |
| ( | |||||
Net assets |
| |
|
| 2019 |
| ||||
$m |
| ||||||
Net cash outflow from operating activities |
| ( | |||||
Net cash inflow from investing activities |
| | |||||
Net cash inflow from financing activities | | ||||||
Increase in cash and cash equivalents in the year |
| |
As part of the acquisition of Alexion in July 2021, a pre-existing non-controlling interest in Caelum Biosciences was recognised (Note 27). This was valued at $
27 Acquisition of business operations
On 21 July 2021, AstraZeneca completed the acquisition of
At closing, Alexion shareholders received
The Group has funded the cash element of the acquisition with $
The acquisition has been accounted for as a business combination using the acquisition method of accounting in accordance with IFRS 3 ‘Business Combinations’ and consequently the Alexion assets acquired, and liabilities assumed, have been recorded by AstraZeneca at fair value, with any excess of the purchase price over the fair value of the identifiable assets and liabilities being recognised as goodwill.
As part of the Alexion acquisition in 2021, we identified the assets (comprising principally launched products and post pre-clinical stage) and liabilities acquired. Attributing fair values to assets acquired and liabilities assumed as part of business combinations is considered to be a key judgement. The purchase price allocation was performed with assistance from an independent valuer to advise on the valuation techniques and key assumptions in the valuation, in particular in respect of the valuation of the intangible assets and inventory.
The fair values assigned to the Alexion business combination in 2021 were:
|
| Fair value |
| ||||
$m |
| ||||||
Non-current assets |
| ||||||
Property, plant and equipment | | ||||||
Right-of-use assets | | ||||||
Intangible assets | | ||||||
Other non-current assets | | ||||||
| |||||||
Current assets | |||||||
Inventories | | ||||||
Trade and other receivables | | ||||||
Intangible assets | | ||||||
Cash and cash equivalents | | ||||||
| |||||||
Current liabilities | |||||||
Interest-bearing loans and borrowings | ( | ||||||
Trade and other payables | ( | ||||||
Other current liabilities | ( | ||||||
( | |||||||
Non-current liabilities | |||||||
Lease liabilities | ( | ||||||
Deferred tax liabilities | ( | ||||||
Other non-current liabilities | ( | ||||||
( | |||||||
Total net assets acquired | | ||||||
Less: non-controlling interests | ( |
F-48
Goodwill | | ||||||
Total fair value of consideration | | ||||||
Less: fair value of equity consideration | ( | ||||||
Less: fair value of replacement employee share awards |
| ( | |||||
Less: cash and cash equivalents acquired | ( | ||||||
Net cash outflow |
| |
The estimated fair value and useful lives of intangible assets were as follows:
| Fair value |
| Useful lives |
| |||
$m | Years |
| |||||
Launched products – C5 franchise (Soliris/Ultomiris) | | ||||||
Launched products – Strensiq, Kanuma, Andexxa | | ||||||
Products in development | | Not amortised | |||||
Other intangibles | | ||||||
|
The fair value attributed to intangible assets was $
The fair value of inventory, which includes raw materials, work in progress and finished goods related to the launched products was estimated at $
Property, plant and equipment principally comprises the manufacturing facilities in Dublin and Athlone, Ireland and was fair valued using a cost approach. The estimated fair value of $
The estimated fair value of contingent liabilities was $
The estimated fair value of trade and other receivables was $
The net deferred tax position reflected an adjustment of $
Goodwill amounting to $
Non-controlling interests reflect Alexion’s pre-existing minority equity interest in Caelum Biosciences and have been valued at $
Alexion’s results have been consolidated into the Group’s results from 21 July 2021. For the period from acquisition to 31 December 2021, before reflecting the fair value adjustments arising on the acquisition, Alexion’s Total Revenues were $
Total acquisition-related costs of $
The terms of the acquisition include a retention bonus plan for legacy Alexion employees whereby up to $
Upon completion of the acquisition, all unvested Alexion employee share awards were converted into AstraZeneca restricted stock awards that continue to have, and shall be subject to, the same terms and conditions as applied in the corresponding Alexion awards immediately prior to completion. Alexion Performance Stock Plan (PSU) awards that included performance-based vesting conditions were converted using the greater of the original target level and Alexion's assessment of the level of achievement immediately prior to completion (subject to a limit of
F-49
28 Financial risk management objectives and policies
The Group’s principal financial instruments, other than derivatives, comprise bank overdrafts, loans and other borrowings, lease liabilities, current and non-current investments, cash and short-term deposits. The main purpose of these financial instruments is to manage the Group’s funding and liquidity requirements. The Group has other financial assets and liabilities such as trade receivables and trade payables, which arise directly from its operations.
The principal financial risks to which the Group is exposed are those of liquidity, interest rate, foreign currency and credit. Each of these is managed in accordance with Board-approved policies. These policies, together with the Group's approach to capital management, are set out below.
Hedge accounting
The Group uses foreign currency borrowings, foreign currency forwards and swaps, currency options, interest rate swaps and cross-currency interest rate swaps for the purpose of hedging its foreign currency and interest rate risks. The Group may designate certain financial instruments as fair value hedges, cash flow hedges or net investment hedges in accordance with IFRS 9. Hedge effectiveness is determined at the inception of the hedge relationship, and through periodic prospective effectiveness assessments to ensure that an economic relationship exists between the hedged item and hedging instrument. Sources of hedge effectiveness will depend on the hedge relationship designation but may include:
| > | a significant change in the credit risk of either party to the hedging relationship |
| > | a timing mismatch between the hedging instrument and the hedged item |
| > | movements in foreign currency basis spread for derivatives in a fair value hedge |
| > | a significant change in the value of the foreign currency denominated net assets of the Group in a net investment hedge. |
The hedge ratio for each designation will be established by comparing the quantity of the hedging instrument and the quantity of the hedged item to determine their relative weighting; for all of the Group’s existing hedge relationships the hedge ratio has been determined as 1:1. Designated hedges are expected to be effective and therefore the impact of ineffectiveness on profit is not expected to be material. The accounting treatment for fair value hedges and debt designated as fair value through profit or loss is disclosed in the Group Accounting Policies section from page 138.
The following table represents the Group’s continuing designated hedge relationships under IFRS 9.
2019
Other comprehensive income | |||||||||||||||||||
Fair value | |||||||||||||||||||
loss | |||||||||||||||||||
Opening |
| Fair value |
| recycled |
| Closing |
|
| |||||||||||
Nominal | balance | (gain)/loss | to the | balance |
|
| Average |
| |||||||||||
amounts | Carrying | 1 January | deferred | income | 31 December | Average | Average | pay |
| ||||||||||
in local | value | 2019 | to OCI | statement | 2019 | maturity | USD FX | interest |
| ||||||||||
currency | $m | $m | $m | $m | $m | year | rate | rate |
| ||||||||||
Fair value hedge – foreign currency and interest rate risk1 |
| ||||||||||||||||||
Cross currency interest rate swap – Euro bond | EUR | | – | – | – | – | 2021 | | USD LIBOR + | ||||||||||
Cash flow hedges – foreign currency and interest rate risk2, 4 | |||||||||||||||||||
Cross currency interest rate swaps – Euro bonds | EUR | ( | ( | | ( | ( | 2025 | | USD | ||||||||||
Net investment hedge – foreign exchange risk3, 4 | |||||||||||||||||||
Transactions matured pre 2019 | – | ( | – | – | ( | – | – | – | |||||||||||
Cross currency interest rate swap – JPY investment5 | JPY | – | ( | | – | ( | 2019 | | JPY | ||||||||||
Cross currency interest rate swap – JPY investment | JPY | | – | ( | – | ( | 2029 | | JPY | ||||||||||
Cross currency interest rate swap – CNY investment | CNY | ( | | ( | – | | 2026 | | CNY | ||||||||||
Foreign currency borrowing – GBP investment | GBP | ( | ( | | – | ( | 2031 | n/a | GBP | ||||||||||
Foreign currency borrowing – EUR investment | EUR | ( | | ( | – | | 2021 | n/a | EUR | ||||||||||
Contingent consideration liabilities and Acerta Pharma put option liability – AZUK and AZAB USD investments | USD | ( | | | – | | – | – | – | ||||||||||
2020
Other comprehensive income | |||||||||||||||||||
Fair value | |||||||||||||||||||
loss | |||||||||||||||||||
Opening |
| Fair value |
| recycled |
| Closing |
|
| |||||||||||
Nominal | balance | (gain)/loss | to the | balance |
|
| Average |
| |||||||||||
amounts | Carrying | 1 January | deferred | income | 31 December | Average | Average | pay |
| ||||||||||
in local | value | 2020 | to OCI | statement | 2020 | maturity | USD FX | interest |
| ||||||||||
currency | $m | $m | $m | $m | $m | year | rate | rate |
| ||||||||||
Fair value hedge – foreign currency and interest rate risk1 | |||||||||||||||||||
Cross currency interest rate swap – Euro bond | EUR | | – | – | – | – | 2021 | | USD LIBOR + | ||||||||||
Cash flow hedges – foreign currency and interest rate risk2, 4, 6 | |||||||||||||||||||
Cross currency interest rate swaps – Euro bonds | EUR | | ( | ( | | | 2025 | | USD | ||||||||||
FX Forwards − short term FX risk | USD | | – | ( | | ( | 2021 | – | – | ||||||||||
Net investment hedge – foreign exchange risk3, 4 | |||||||||||||||||||
Transactions matured pre 2020 | – | ( | – | – | ( | – | – | – | |||||||||||
Cross currency interest rate swap – JPY investment | JPY | | ( | ( | – | ( | 2029 | | JPY | ||||||||||
Cross currency interest rate swap – CNY investment | CNY | ( | | | – | | 2026 | | CNY | ||||||||||
Foreign currency borrowing – GBP investment | GBP | ( | ( | | – | ( | 2031 | n/a | GBP | ||||||||||
Foreign currency borrowing – EUR investment | EUR | ( | | | – | | 2021 | n/a | EUR | ||||||||||
Contingent consideration liabilities and Acerta Pharma put option liability – AZUK and AZAB USD investments | USD | ( | | ( | – | | – | – | – | ||||||||||
F-50
2021
Other comprehensive income | |||||||||||||||||||
Fair value | |||||||||||||||||||
gain | |||||||||||||||||||
Opening |
| Fair value |
| recycled |
| Closing |
|
| |||||||||||
Nominal | balance | (gain)/loss | to the | balance |
|
| Average |
| |||||||||||
amounts | Carrying | 1 January | deferred | income | 31 December | Average | Average | pay |
| ||||||||||
in local | value | 2021 | to OCI | statement | 2021 | maturity | USD FX | interest |
| ||||||||||
currency | $m | $m | $m | $m | $m | year | rate | rate |
| ||||||||||
Fair value hedge – foreign currency and interest rate risk1 | |||||||||||||||||||
Cross currency interest rate swap – Euro bond | – | – | – | – | – | – | – | – | – | ||||||||||
Cash flow hedges – foreign currency and interest rate risk2, 4, 6 | |||||||||||||||||||
Cross currency interest rate swaps – Euro bonds | EUR | ( | | | ( | | 2026 | | USD | ||||||||||
FX Forwards − short term FX risk | USD | | ( | – | ( | ( | 2022 | – | – | ||||||||||
Net investment hedge – foreign exchange risk3, 4 | |||||||||||||||||||
Transactions matured pre-2021 | – | ( | – | – | ( | – | – | – | |||||||||||
Cross currency interest rate swap – JPY investment | JPY | | ( | ( | – | ( | 2029 | | JPY | ||||||||||
Cross currency interest rate swap – CNY investment | CNY | ( | | – | – | | 2026 | | CNY | ||||||||||
Foreign currency borrowing – GBP investment | GBP | | ( | ( | – | ( | 2031 | n/a | GBP | ||||||||||
Foreign currency borrowing - EUR investment7 | EUR | – | | ( | – | | 2021 | n/a | EUR | ||||||||||
Foreign currency borrowing - EUR investment8 | EUR | | – | ( | – | ( | 2029 | n/a | EUR | ||||||||||
Contingent consideration liabilities and Acerta Pharma share purchase liability – AZUK and AZAB USD investments | USD | ( | | | – | | – | – | – | ||||||||||
| 1 | Swaps designated in a fair value hedge matured on 24 November 2021 and hedge ineffectiveness during the period was $nil (2020: gain of $ |
| 2 | Hedge ineffectiveness recognised on swaps designated in a cash flow hedge during the period was $nil (2020: $nil). |
| 3 | Hedge ineffectiveness recognised on swaps designated in a net investment hedge during the period was $nil (2020: $nil). |
| 4 | Fair value movements on cross currency interest rate swaps in cash flow hedge and net investment hedge relationships are shown inclusive of the impact of costs of hedging. |
| 5 | In September 2019, the maturity of our JPY |
| 6 | Nominal amount of FX forwards in a cash flow hedge of $ |
| 7 | The EUR |
| 8 | On 3 June 2021, upon issuance of the EUR |
Capital management
The capital structure of the Group consists of Shareholders’ equity (Note 24), Debt (Note 19), Other current investments (Note 12) and Cash (Note 17). For the foreseeable future, the Board will maintain a capital structure that supports the Group’s strategic objectives through:
| > | managing funding and liquidity risk |
| > | optimising shareholder return |
| > | maintaining a strong, investment-grade credit rating. |
The Group utilises factoring arrangements for selected trade receivables. These factoring arrangements qualify for full derecognition of the associated trade receivables under IFRS 9. Amounts due on invoices that have not been factored at year end, from customers that are subject to factoring arrangements, are disclosed in Note 16.
Funding and liquidity risk are reviewed regularly by the Board and managed in accordance with policies described below.
The Board’s distribution policy comprises a regular cash dividend and, subject to business needs, a share repurchase component. The Board regularly reviews its shareholders’ return strategy, and, in 2012, decided to suspend share repurchases in order to retain strategic flexibility.
The Group’s net debt position (loans and borrowings net of Cash and cash equivalents, Other investments and Derivative financial instruments) has increased from a net debt position of $
Liquidity risk
The Board reviews the Group’s ongoing liquidity risks annually as part of the planning process and on an ad hoc basis. The Board considers short-term requirements against available sources of funding, taking into account forecast cash flows. The Group manages liquidity risk by maintaining access to a number of sources of funding which are sufficient to meet anticipated funding requirements. Specifically, the Group uses US and European commercial paper, bank loans, committed bank facilities and cash resources to manage short-term liquidity and manages long-term liquidity by raising funds through the capital markets. At 31 December 2021, the Group was assigned short-term credit ratings of P-2 by Moody’s and A-2 by Standard and Poor’s. The Group’s long-term credit rating was A3 Negative outlook by Moody’s and A- Stable outlook by Standard and Poor’s.
In addition to Cash and cash equivalents of $
At 31 December 2021, the Group has $
F-51
The maturity profile of the anticipated future contractual cash flows including interest in relation to the Group’s financial liabilities, on an undiscounted basis and which, therefore, differs from both the carrying value and fair value, is as follows:
| Bank |
|
|
|
| Total |
| Derivative |
| Derivative |
| Total |
|
| |||||
overdrafts | Trade | non-derivative | financial | financial | derivative |
| |||||||||||||
and other | Lease | and other | financial | instruments | instruments | financial |
| ||||||||||||
loans | Bonds | liability | payables | instruments | receivable | 1 | payable | instruments | Total |
| |||||||||
$m | $m | $m | $m | $m | $m | $m | $m | $m |
| ||||||||||
Within one year |
| | | | | | ( | | | | |||||||||
In one to two years |
| | | | | | ( | | | | |||||||||
In two to three years |
| – | | | | | ( | | | | |||||||||
In three to four years |
| – | | | | | ( | | | | |||||||||
In four to five years |
| – | | | | | ( | | | | |||||||||
In more than five years |
| – | | | | | ( | | | | |||||||||
| | | | | | ( | | | | ||||||||||
Effect of interest |
| ( | ( | – | – | ( | | ( | ( | ( | |||||||||
Effect of discounting, fair values and issue costs |
| ( | ( | ( | ( | ( | ( | ( | ( | ( | |||||||||
31 December 2019 |
| | | | | | ( | | ( | |
| Bank |
|
|
|
| Total |
| Derivative |
| Derivative |
| Total |
|
| |||||
overdrafts | Trade | non-derivative | financial | financial | derivative |
| |||||||||||||
and other | Lease | and other | financial | instruments | instruments | financial |
| ||||||||||||
loans | Bonds | liability | payables | instruments | receivable | payable | instruments | Total |
| ||||||||||
$m | $m | $m | $m | $m | $m | $m | $m | $m |
| ||||||||||
Within one year |
| | | | | | ( | | ( | | |||||||||
In one to two years |
| – | | | | | ( | | | | |||||||||
In two to three years |
| – | | | | | ( | | | | |||||||||
In three to four years |
| – | | | | | ( | | ( | | |||||||||
In four to five years |
| – | | | | | ( | | | | |||||||||
In more than five years |
| – | | | | | ( | | ( | | |||||||||
| | | | | | ( | | ( | | ||||||||||
Effect of interest |
| – | ( | – | – | ( | | ( | ( | ( | |||||||||
Effect of discounting, fair values and issue costs |
| ( | ( | ( | ( | ( | ( | | ( | ( | |||||||||
31 December 2020 |
| | | | | | ( | | ( | |
| Bank |
|
|
|
| Total |
| Derivative |
| Derivative |
| Total |
|
| |||||
overdrafts | Trade | non-derivative | financial | financial | derivative |
| |||||||||||||
and other | Lease | and other | financial | instruments | instruments | financial |
| ||||||||||||
loans | Bonds | liability | payables | instruments | receivable | payable | instruments | Total |
| ||||||||||
$m | $m | $m | $m | $m | $m | $m | $m | $m |
| ||||||||||
Within one year |
| | | | | | ( | | | | |||||||||
In one to two years |
| – | | | | | ( | | | | |||||||||
In two to three years |
| – | | | | | ( | | | | |||||||||
In three to four years |
| – | | | | | ( | | | | |||||||||
In four to five years |
| – | | | | | ( | | ( | | |||||||||
In more than five years |
| – | | | | | ( | | ( | | |||||||||
| | | | | | ( | | ( | | ||||||||||
Effect of interest |
| – | ( | – | – | ( | | ( | ( | ( | |||||||||
Effect of discounting, fair values and issue costs |
| – | ( | ( | ( | ( | ( | | ( | ( | |||||||||
31 December 2021 |
| | | | | | ( | | ( | |
| 1 | The maturity profile table has been amended in 2019 to show gross derivative flows and to include all derivatives shown in Note 13 on page 161. In previous periods the table separately disclosed the net cash flows on interest rate swaps and cross-currency swaps. |
Where interest payments are on a floating rate basis, it is assumed that rates will remain unchanged from the last business day of each year ended 31 December.
The Group has $
Market risk
Interest rate risk
The Group maintains a Board approved mix of fixed and floating rate debt and uses underlying debt, interest rate swaps and forward rate agreements to manage this mix.
At 31 December 2021, interest rate swaps with a notional value of $
The majority of surplus cash is currently invested in US dollar liquidity funds and investment-grade fixed income securities.
F-52
The interest rate profile of the Group’s interest-bearing financial instruments are set out below. In the case of current and non-current financial liabilities, the classification includes the impact of interest rate swaps which convert the debt to floating rate.
2021 | 2020 | 2019 |
| ||||||||||||||||
| Fixed rate |
| Floating rate |
| Total |
| Fixed rate |
| Floating rate |
| Total |
| Fixed rate |
| Floating rate |
| Total |
| |
| $m |
| $m |
| $m |
| $m |
| $m |
| $m |
| $m |
| $m |
| $m |
| |
Financial liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Interest-bearing loans and borrowings |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Current |
| | | | | | | | | | |||||||||
Non-current |
| | | | | | | | | | |||||||||
Total |
| | | | | | | | | | |||||||||
Financial assets |
| ||||||||||||||||||
Fixed deposits |
| | – | | | – | | | – | | |||||||||
Cash and cash equivalents |
| – | | | – | | | – | | | |||||||||
Total |
| | | | | | | | | |
In addition to the financial assets above, there are $
The Group is also exposed to market risk on equity securities, which represent non-controlling interests in third-party biotech companies.
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Equity securities at fair value through Other comprehensive income (Note 12) | | | | ||||
Total |
| |
| |
| |
Foreign currency risk
The US dollar is the Group’s most significant currency. As a consequence, the Group results are presented in US dollars and exposures are managed against US dollars accordingly.
Translational
Approximately
This currency exposure is managed centrally, based on forecast cash flows. The impact of movements in exchange rates is mitigated significantly by the correlations which exist between the major currencies to which the Group is exposed and the US dollar. Monitoring of currency exposures and correlations is undertaken on a regular basis and hedging is subject to pre-execution approval.
As at 31 December 2021, before the impact of derivatives,
The Group holds cross-currency swaps to hedge against the impact of fluctuations in foreign exchange rates. Fair value movements on the revaluation of the cross-currency swaps are recognised in Other comprehensive income to the extent that the hedge is effective, with any ineffectiveness taken to profit.
Foreign currency risk arises when the Group has inter-company funding and investments in certain subsidiaries operating in countries with exchange controls or where there is risk of significant future currency devaluation. One indicator of potential foreign currency risk is where a country is officially designated as hyperinflationary. As at 31 December 2021, the Group operates in
The foreign exchange risk to the Group from Argentina and Venezuela has been assessed and deemed to be immaterial.
Transactional
The Group aims to hedge all its forecast major transactional currency exposures on working capital balances, which typically extend for up to three months. Where practicable, these are hedged using forward foreign exchange. In addition, the Group’s external dividend, which is paid principally in pounds sterling and Swedish krona, is fully hedged from announcement to payment date. Foreign exchange gains and losses on forward contracts transacted for transactional hedging are taken to profit. Foreign exchange gains and losses on forward contracts transacted for transactional hedging are taken to profit or to Other comprehensive income if the contract is in a designated cash flow hedge.
Sensitivity analysis
The sensitivity analysis set out below summarises the sensitivity of the market value of our financial instruments to hypothetical changes in market rates and prices. The range of variables chosen for the sensitivity analysis reflects our view of changes which are reasonably possible over a one-year period. Market values are the present value of future cash flows based on market rates and prices at the valuation date. For long-term debt, an increase in interest rates results in a decline in the fair value of debt.
The sensitivity analysis assumes an instantaneous basis point change in interest rates in all currencies from their levels at 31 December 2021, with all other variables held constant. Based on the composition of our long-term debt portfolio as at 31 December 2021, a
F-53
Each incremental
Interest rates | Exchange rates | ||||||||
31 December 2019 |
| +1% |
| −1% |
| +10% |
| −10% | |
Increase/(decrease) in fair value of financial instruments ($m) |
| | ( | ( | ( | ||||
Impact on profit: (loss)/gain ($m) |
| – | – | ( | | ||||
Impact on equity: gain/(loss) ($m) |
| – | – | | ( |
Interest rates | Exchange rates | ||||||||
31 December 2020 |
| +1% |
| −1% |
| +10% |
| −10% | |
Increase/(decrease) in fair value of financial instruments ($m) |
| | ( | | ( | ||||
Impact on profit: (loss)/gain ($m) |
| – | – | ( | | ||||
Impact on equity: gain/(loss) ($m) |
| – | – | | ( |
Interest rates | Exchange rates | ||||||||
31 December 2021 |
| +1% |
| −1% |
| +10% |
| −10% | |
Increase/(decrease) in fair value of financial instruments ($m) |
| | ( | | ( | ||||
Impact on profit: gain/(loss) ($m) |
| – | – | | ( | ||||
Impact on equity: gain/(loss) ($m) |
| – | – | | ( |
Credit risk
The Group is exposed to credit risk on financial assets, such as cash investments, derivative instruments, and Trade and other receivables. The Group is also exposed in its Net asset position to its own credit risk in respect of the 2023 debentures which are accounted for at fair value through profit or loss. Under IFRS 9, the effect of the losses and gains arising from own credit risk on the fair value of bonds designated at fair value through profit or loss are recorded in Other comprehensive income.
Financial counterparty credit risk
The majority of the AstraZeneca Group’s cash is centralised within the Group treasury entity and is subject to counterparty risk on the principal invested. The level of the Group’s cash investments and hence credit risk will depend on the cash flow generated by the Group and the timing of the use of that cash. The credit risk is mitigated through a policy of prioritising security and liquidity over return and, as such, cash is only invested in high credit-quality investments. Counterparty limits are set according to the assessed risk of each counterparty and exposures are monitored against these limits on a regular basis.
The Group’s principal financial counterparty credit risks at 31 December 2021 were as follows:
Current assets
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Cash at bank and in hand |
| |
| |
| | |
Money market liquidity funds |
| |
| |
| | |
Collateralised repurchase agreement |
| – |
| – |
| | |
Other short-term cash equivalents | | | | ||||
Total Cash and cash equivalents (Note 17) |
| |
| |
| | |
Fixed income securities at fair value through profit and loss (Note 12) | | | | ||||
Fixed deposits (Note 12) | | | | ||||
Total derivative financial instruments (Note 13) |
| |
| |
| | |
Current assets subject to credit risk |
| |
| |
| |
Non-current assets
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Fixed income securities at fair value through profit and loss (Note 12) | – | – | | ||||
Derivative financial instruments (Note 13) |
| |
| |
| | |
Non-current assets subject to credit risk |
| |
| |
| |
The majority of the Group’s cash is invested in US dollar AAA rated money market liquidity funds. The money market liquidity fund portfolios are managed by
The short-term repurchase agreements were fully collateralised investments. The Group closed out its repurchase agreements during 2020. The value of the cash deposited in repurchase agreements at 31 December 2021 was $
The fixed income securities were managed by
All financial derivatives are transacted with commercial banks, in line with standard market practice. The Group has agreements with some bank counterparties whereby the parties agree to post cash collateral, for the benefit of the other, equivalent to the market valuation of the derivative positions above a predetermined threshold. The carrying value of such cash collateral held by the Group at 31 December 2021 was $
The impairment provision for other financial assets at 31 December 2021 was immaterial.
Trade receivables
Trade receivable exposures are managed locally in the operating units where they arise and credit limits are set as deemed appropriate for the customer. The Group is exposed to customers ranging from government-backed agencies and large private wholesalers to privately owned pharmacies, and the underlying local economic and sovereign risks vary throughout the world. Where appropriate, the Group endeavours to
F-54
minimise risks by the use of trade finance instruments such as letters of credit and insurance. The Group applies the expected credit loss approach to establish an allowance for impairment that represents its estimate of expected losses in respect of Trade receivables.
The Group applies the IFRS 9 simplified approach to measuring expected credit losses which uses a lifetime expected loss allowance for all Trade receivables. To measure expected credit losses, Trade receivables have been grouped based on shared credit characteristics and the days past due.
The expected loss rates are based on payment profiles over a period of
On that basis, the loss allowance was determined as follows:
|
| 0-90 days |
| 90-180 days |
| Over 180 days |
|
| |||
31 December 2019 |
| Current |
| past due |
| past due |
| past due |
| Total |
|
Expected loss rate |
| % | | % | | % | | % |
| ||
Gross carrying amount ($m) |
| | | |
| | | ||||
Loss allowance ($m) |
| | | |
| | |
|
| 0-90 days |
| 90-180 days |
| Over 180 days |
|
| |||
31 December 2020 |
| Current |
| past due |
| past due |
| past due |
| Total |
|
Expected loss rate |
| % | | % | | % | | % | |||
Gross carrying amount ($m) |
| | | | | | |||||
Loss allowance ($m) |
| | | | | |
|
| 0-90 days |
| 90-180 days |
| Over 180 days |
|
| |||
31 December 2021 |
| Current |
| past due |
| past due |
| past due |
| Total |
|
Expected loss rate |
| % | | % | | % | | % | |||
Gross carrying amount ($m) |
| | | | | | |||||
Loss allowance ($m) |
| | | | | |
Trade receivables are written off where there is no reasonable expectation of recovery.
Impairment losses on Trade receivables are presented as net impairment losses within Operating profit, any subsequent recoveries are credited against the same line.
In the US, sales to
The movements of the Group expected credit losses provision are follows:
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
At 1 January |
| |
| |
| | |
Net movement recognised in income statement |
| ( |
| |
| ( | |
Amounts utilised, exchange and other movements |
| |
| ( |
| ( | |
At 31 December |
| |
| |
| |
Given the profile of our customers, including large wholesalers and government-backed agencies, no further credit risk has been identified with the Trade receivables not past due other than those balances for which an allowance has been made. The income statement credit or charge is recorded in Operating profit.
29 Employee costs and share plans for employees
Employee costs
The monthly average number of people, to the nearest hundred, employed by the Group is set out in the table below. In accordance with the Companies Act 2006, this includes part-time employees.
| 2021 |
| 2020 |
| 2019 |
| |
Employees |
|
|
|
|
|
| |
UK |
| |
| |
| | |
Rest of Europe |
| |
| |
| | |
The Americas |
| |
| |
| | |
Asia, Africa & Australasia |
| |
| |
| | |
Continuing operations |
| |
| |
| |
Geographical distribution described in the table above is by location of legal entity employing staff. Certain staff will undertake some or all of their activity in a different location.
The number of people employed by the Group at the end of 2021 was
F-55
The costs incurred during the year in respect of these employees were:
| 2021 |
| 2020 |
| 2019 |
| |
$m | $m | $m |
| ||||
Wages and salaries |
| |
| |
| | |
Social security costs |
| |
| |
| | |
Pension costs |
| |
| |
| | |
Other employment costs |
| |
| |
| | |
Total |
| |
| |
| |
Severance costs of $
The Directors believe that, together with the basic salary system, the Group’s employee incentive schemes provide competitive and market-related packages to motivate employees. They should also align the interests of employees with those of shareholders, as a whole, through long-term share ownership in the Company. The Group’s current UK, Swedish and US schemes are described below; other arrangements apply elsewhere.
Bonus plans
The AstraZeneca UK Performance Bonus Plan
Employees of participating AstraZeneca UK companies are invited to participate in this bonus plan, which rewards strong individual performance. Bonuses are paid in cash.
The AstraZeneca Executive Annual Bonus Scheme
This scheme is a performance bonus scheme for Directors and senior employees who do not participate in the AstraZeneca UK Performance Bonus Plan. Annual bonuses are paid in cash and reflect both corporate and individual performance measures. The Remuneration Committee has discretion to reduce or withhold bonuses if business performance falls sufficiently short of expectations in any year such as to make the payment of bonuses inappropriate.
The AstraZeneca Deferred Bonus Plan
This plan was introduced in 2006 and is used to defer a portion of the bonus earned under the AstraZeneca Executive Annual Bonus Scheme into Ordinary Shares in the Company for a period of
Sweden
In Sweden, an all-employee performance bonus plan is in operation, which rewards strong individual performance. Bonuses are paid
US
In the US, there are
Share plans
The charge for share-based payments in respect of share plans is $
The AstraZeneca UK All-Employee Share Plan
The Company offers UK employees the opportunity to buy Partnership Shares (Ordinary Shares). Employees may invest up to £
The AstraZeneca 2014 Performance Share Plan
This plan was approved by shareholders in 2014 for a period of
F-56
any awards under the plan and for setting the policy for the way in which the plan should be operated, including agreeing performance targets and which employees should be invited to participate.
Ordinary Shares |
| WAFV | 1 | ADR Shares | WAFV | 1 | |||
ʼ000 | pence | ʼ000 | $ | ||||||
Outstanding at 1 January 2019 | | | | | |||||
Granted | | | | | |||||
Forfeited | ( | | ( | | |||||
Exercised | ( | | ( | | |||||
Outstanding at 31 December 2019 | | | | | |||||
Granted | | | | | |||||
Forfeited | ( | | ( | | |||||
Cancelled |
| ( | | – | – | ||||
Exercised | ( | | ( | | |||||
Outstanding at 31 December 2020 | | | | | |||||
Granted | | | | | |||||
Forfeited | ( | | ( | | |||||
Cancelled | ( | | – | – | |||||
Exercised | ( | | ( | | |||||
Outstanding at 31 December 2021 |
| | | | |
| 1 | Weighted average fair value. |
The AstraZeneca Investment Plan
This plan was introduced in 2010 and approved by shareholders at the 2010 AGM. The final grant of awards under this plan took place in March 2016. Awards granted under the plan vest after
The AstraZeneca Global Restricted Stock Plan
This plan was introduced in 2010. This plan provides for the grant of restricted stock unit (RSU) awards to selected below SET-level employees and is used in conjunction with the AstraZeneca Performance Share Plan to provide a mix of RSUs and performance shares. Awards typically vest on the third anniversary of the date of grant and are contingent on continued employment with the Company. The Remuneration Committee has responsibility for agreeing any awards under the plan and for setting the policy for the way in which the plan should be operated.
| Ordinary Shares |
| WAFV | ADR Shares | WAFV | ||||
ʼ000 | pence | ʼ000 | $ | ||||||
Outstanding at 1 January 2019 | | | | | |||||
Granted | | | | | |||||
Forfeited |
| ( | | ( | | ||||
Cancelled | – | – | ( | | |||||
Exercised | ( | | ( | | |||||
Outstanding at 31 December 2019 | | | | | |||||
Granted | | | | | |||||
Forfeited |
| ( | | ( | | ||||
Cancelled | – | | ( | | |||||
Exercised | ( | | ( | | |||||
Outstanding at 31 December 2020 | | | | | |||||
Granted | | | | | |||||
Forfeited | ( | | ( | | |||||
Cancelled | ( | | ( | | |||||
Exercised | ( | | ( | | |||||
Outstanding at 31 December 2021 |
| | | | |
The AstraZeneca Restricted Share Plan
This plan was introduced in 2008 and provides for the grant of restricted share awards to key employees, excluding Executive Directors. Awards are made on an ad hoc basis with variable vesting dates. The plan has been used
F-57
Remuneration Committee has responsibility for agreeing any awards under the plan and for setting the policy for the way in which the plan should be operated.
| Ordinary Shares |
| WAFV |
| ADR Shares | WAFV | |||
ʼ000 | pence | ʼ000 | $ | ||||||
Outstanding at 1 January 2019 | | | | | |||||
Granted | | | | | |||||
Forfeited | ( | | ( | | |||||
Cancelled | – | – | ( | | |||||
Exercised |
| ( | | ( | | ||||
Outstanding at 31 December 2019 | | | | | |||||
Granted | | | | | |||||
Forfeited | ( | | ( | | |||||
Exercised |
| ( | | ( | | ||||
Outstanding at 31 December 2020 | | | | | |||||
Granted | | | | | |||||
Forfeited | ( | | ( | | |||||
Exercised | ( | | ( | | |||||
Outstanding at 31 December 2021 |
| | | | |
The AstraZeneca Extended Incentive Plan
This plan was introduced in 2018 and provides for the grant of awards to key employees, excluding Executive Directors. Awards are made on an ad hoc basis and
| Ordinary Shares |
| WAFV |
| ADR Shares | WAFV | |||
ʼ000 | pence | ʼ000 | $ | ||||||
Outstanding at 1 January 2019 | | | | | |||||
Granted | | | – | – | |||||
Outstanding at 31 December 2019 | | | | | |||||
Granted | | | – | – | |||||
Outstanding at 31 December 2020 | | | | | |||||
Granted | – | – | | | |||||
Forfeited | ( | | ( | | |||||
Outstanding at 31 December 2021 |
| | | | |
Alexion employee share award plan
Alexion employee share awards were converted into AstraZeneca restricted stock awards that continue to have, and shall be subject to, the same terms and conditions as applied in the corresponding Alexion awards immediately prior to completion.
Ordinary Shares |
| WAFV |
| ADR Shares | WAFV | ||||
ʼ000 | pence | ʼ000 | $ | ||||||
Outstanding at 1 January 2021 | – | – | – | – | |||||
Granted | – | – | | | |||||
Forfeited | – | – | ( | | |||||
Exercised | – | – | ( | | |||||
Outstanding at 31 December 2021 | – | – | | |
The fair values for the market-based performance conditions of the AstraZeneca 2014 Performance Share Plan were determined using a modified version of the Monte Carlo model. This method incorporated market inputs in addition to expected dividends. The fair values of all other plans are set using the market price at the point of award. The grant date fair values of share awards disclosed in this section do not take account of service and non-market related performance conditions.
30 Commitments and contingent liabilities
| 2021 |
| 2020 |
| 2019 |
| |
Commitments | $m | $m | $m |
| |||
Contracts placed for future capital expenditure on Property, plant and equipment and |
| |
| |
| |
Guarantees and contingencies arising in the ordinary course of business, for which no security has been given, are not expected to result in any material financial loss.
Research and development collaboration payments
The Group has various ongoing collaborations, including in-licensing and similar arrangements with development partners. Such collaborations may require the Group to make payments on achievement of stages of development, launch or revenue milestones, although the Group generally has the right to terminate these agreements at no cost. The Group recognises research and development milestones as an intangible asset once it is committed to payment, which is generally when the Group reaches set trigger points in the development cycle. Revenue-related milestones are
F-58
recognised as intangible assets on product launch at a value based on the Group’s long-term revenue forecasts for the related product. The table below indicates potential development and revenue-related payments that the Group may be required to make under such collaborations.
|
| Years 5 |
| ||||||||
Total |
| Under 1 year |
| Years 1 and 2 |
| Years 3 and 4 | and greater |
| |||
$m | $m | $m | $m | $m |
| ||||||
Future potential research and development milestone payments |
| | | | | | |||||
Future potential revenue milestone payments |
| | | | | |
The table includes all potential payments for achievement of milestones under ongoing research and development arrangements. Revenue-related milestone payments represent the maximum possible amount payable on achievement of specified levels of revenue as set out in individual contract agreements, but exclude variable payments that are based on unit sales (e.g. royalty-type payments) which are expensed as the associated sale is recognised. The table excludes any payments already capitalised in the Financial Statements for the year ended 31 December 2021.
The future payments we disclose represent contracted payments and, as such, are not discounted and are not risk-adjusted. As detailed in the Risk section from page 48, the development of any pharmaceutical product candidate is a complex and risky process that may fail at any stage in the development process due to a number of factors (including items such as failure to obtain regulatory approval, unfavourable data from key studies, adverse reactions to the product candidate or indications of other safety concerns). The timing of the payments is based on the Group’s current best estimate of achievement of the relevant milestone.
Environmental costs and liabilities
The Group’s expenditure on environmental protection, including both capital and revenue items, relates to costs that are necessary for implementing internal systems and programmes, and meeting legal and regulatory requirements for processes and products. This includes investment to conserve natural resources and otherwise minimise the impact of our activities on the environment.
They are an integral part of normal ongoing expenditure for carrying out the Group’s research, manufacturing and commercial operations and are not separated from overall operating and development costs. There are no known changes in legal, regulatory or other requirements resulting in material changes to the levels of expenditure for 2019, 2020 or 2021.
In addition to expenditure for meeting current and foreseen environmental protection requirements, the Group incurs costs in investigating and cleaning up land and groundwater contamination. In particular, AstraZeneca has environmental liabilities at some currently or formerly owned, leased and third-party sites.
In the US, Zeneca Inc., and/or its indemnitees, have been named as potentially responsible parties (PRPs) or defendants at a number of sites where Zeneca Inc. is likely to incur future environmental investigation, remediation, operation and maintenance costs under federal, state, statutory or common law environmental liability allocation schemes (together, US Environmental Consequences). Similarly, Stauffer Management Company LLC (SMC), which was established in 1987 to own and manage certain assets of Stauffer Chemical Company acquired that year, and/or its indemnitees, have been named as PRPs or defendants at a number of sites where SMC is likely to incur US Environmental Consequences.
AstraZeneca has also given indemnities to third parties for a number of sites outside the US. These environmental liabilities arise from legacy operations that are not currently part of the Group’s business and, at most of these sites, remediation, where required, is either completed or in progress. AstraZeneca has made provisions for the estimated costs of future environmental investigation, remediation, operation and maintenance activity beyond normal ongoing expenditure for maintaining the Group’s R&D and manufacturing capacity and product ranges, where a present obligation exists, it is probable that such costs will be incurred and they can be estimated reliably. With respect to such estimated future costs, there were provisions at 31 December 2021 in the aggregate of $
It is possible that AstraZeneca could incur future environmental costs beyond the extent of our current provisions. The extent of such possible additional costs is inherently difficult to estimate due to a number of factors, including: (i) the nature and extent of claims that may be asserted in the future; (ii) whether AstraZeneca has or will have any legal obligation with respect to asserted or unasserted claims; (iii) the type of remedial action, if any, that may be selected at sites where the remedy is presently not known; (iv) the potential for recoveries from or allocation of liability to third parties; and (v) the length of time that the environmental investigation, remediation and liability allocation process can take. As per our accounting policy on page 144, Provisions for these costs are made when there is a present obligation and where it is probable that expenditure on remedial work will be required and a reliable estimate can be made of the cost. Notwithstanding and subject to the foregoing, we estimate the potential additional loss for future environmental investigation, remediation, remedial operation and maintenance activity above and beyond our provisions to be, in aggregate, between $
Legal proceedings
AstraZeneca is involved in various legal proceedings considered typical to its business, including actual or threatened litigation and actual or potential government investigations relating to employment matters, product liability, commercial disputes, pricing, sales and marketing practices, infringement of IP rights, and the validity of certain patents and competition laws. The more significant matters are discussed below.
Most of the claims involve highly complex issues. Often these issues are subject to substantial uncertainties and, therefore, the probability of a loss, if any, being sustained and/or an estimate of the amount of any loss is difficult to ascertain.
Unless specifically identified below that a provision has been taken, AstraZeneca considers each of the claims to represent a contingent liability and discloses information with respect to the nature and facts of the cases in accordance with IAS 37.
There is one matter, which is considered probable that an outflow will be required, but for which we are unable to make an estimate of the possible loss or range of possible losses at this stage.
We do not believe that disclosure of the amounts sought by plaintiffs, if known, would be meaningful with respect to these legal proceedings. This is due to a number of factors, including (i) the stage of the proceedings (in many cases trial dates have not been set) and the overall length and extent of pre-trial discovery; (ii) the entitlement of the parties to an action to appeal a decision; (iii) clarity as to theories of liability, damages and governing law; (iv) uncertainties in timing of litigation; and (v) the possible need for further legal proceedings to establish the appropriate amount of damages, if any.
While there can be no assurance regarding the outcome of any of the legal proceedings referred to in this Note 30, based on management’s current and considered view of each situation, we do not currently expect them to have a material adverse effect on our financial position including within the next financial year. This position could of course change over time, not least because of the factors referred to above.
F-59
In cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed and which are not subject to appeal (or other similar forms of relief), or where a loss is probable and we are able to make a reasonable estimate of the loss, we generally indicate the loss absorbed or make a provision for our best estimate of the expected loss.
Where it is considered that the Group is more likely than not to prevail, legal costs involved in defending the claim are charged to profit as they are incurred.
Where it is considered that the Group has a valid contract which provides the right to reimbursement (from insurance or otherwise) of legal costs and/or all or part of any loss incurred or for which a provision has been established, and we consider recovery to be virtually certain, the best estimate of the amount expected to be received is recognised as an asset.
Assessments as to whether or not to recognise provisions or assets, and of the amounts concerned, usually involve a series of complex judgements about future events and can rely heavily on estimates and assumptions. AstraZeneca believes that the provisions recorded are adequate based on currently available information and that the insurance recoveries recorded will be received. However, given the inherent uncertainties involved in assessing the outcomes of these cases, and in estimating the amount of the potential losses and the associated insurance recoveries, we could in the future incur judgments or insurance settlements that could have a material adverse effect on our results in any particular period.
IP claims include challenges to the Group’s patents on various products or processes and assertions of non-infringement of patents. A loss in any of these cases could result in loss of patent protection on the related product. The consequences of any such loss could be a significant decrease in Product Sales, which could have a material adverse effect on our results. The lawsuits filed by AstraZeneca for patent infringement against companies that have filed abbreviated new drug applications (ANDAs) in the US, seeking to market generic forms of products sold by the Group prior to the expiry of the applicable patents covering these products, typically also involve allegations of non-infringement, invalidity and unenforceability of these patents by the ANDA filers. In the event that the Group is unsuccessful in these actions or the statutory 30-month stay expires before a ruling is obtained, the ANDA filers involved will also have the ability, subject to FDA approval, to introduce generic versions of the product concerned.
AstraZeneca has full confidence in, and will vigorously defend and enforce, its IP.
Over the course of the past several years, including in 2021, a significant number of commercial litigation claims in which AstraZeneca is involved have been resolved, particularly in the US, thereby reducing potential contingent liability exposure arising from such litigation. Similarly, in part due to patent litigation and settlement developments, greater certainty has been achieved regarding possible generic entry dates with respect to some of our patented products. At the same time, like other companies in the pharmaceutical sector and other industries, AstraZeneca continues to be subject to government investigations around the world.
Patent litigation
Calquence
US patent proceedings
In February 2022, in response to Paragraph IV notices from multiple ANDA filers, AstraZeneca filed patent infringement lawsuits in the US District Court for the District of Delaware. In its complaint, AstraZeneca alleged that a generic version of Calquence, if approved and marketed, would infringe patents listed in the US FDA Orange Book with reference to Calquence that are owned or licensed by AstraZeneca. No trial date has been set.
Tagrisso
US patent proceedings
In February 2020, in response to Paragraph IV notices from multiple ANDA filers, AstraZeneca filed patent infringement lawsuits in the US District Court for the District of Delaware. In its complaint, AstraZeneca alleged that a generic version of Tagrisso, if approved and marketed, would infringe a US Orange Book-listed Tagrisso patent. In the fourth quarter of 2021, AstraZeneca entered into settlement agreements with Zydus Pharmaceuticals (USA) Inc. and Cadila Healthcare Limited (collectively, Zydus) and MSN Laboratories Pvt. Ltd. and MSN Pharmaceuticals Inc. (collectively, MSN), resolving all US patent litigation with Zydus and MSN relating to Tagrisso. The trial with the remaining defendant, Alembic Pharmaceuticals Limited, is scheduled for May 2022.
In September 2021, Puma Biotechnology, Inc. and Wyeth LLC filed a patent infringement lawsuit in the US District Court for the District of Delaware against AstraZeneca relating to Tagrisso. Neither a case schedule, nor a trial date have been set yet.
Patent proceedings outside the US
In Russia in October 2021, AstraZeneca filed a lawsuit in the Arbitration Court of the Moscow Region against Axelpharm, LLC to prevent it from obtaining authorisation to market a generic version of Tagrisso prior to the expiration of AstraZeneca’s patents covering Tagrisso. The lawsuit also names the Ministry of Health of the Russian Federation as a third party. Neither a case schedule, nor a trial date have been set.
Faslodex
Patent proceedings outside the US
In Japan, in April 2021, AstraZeneca received notice from the Japan Patent Office that Sandoz K.K. filed a Request for Invalidation of the Faslodex formulation patent. In October 2021, AstraZeneca received notice that Sun Pharma Japan Ltd. requested to intervene in the Request for Invalidation brought by Sandoz K.K seeking invalidation of the Faslodex formulation patent. The Japan Patent Office has permitted the intervention. AstraZeneca is defending the challenged patent.
Farxiga/Forxiga
US patent proceedings
In 2018, in response to Paragraph IV notices, AstraZeneca initiated ANDA litigation against Zydus Pharmaceuticals (USA) Inc. (Zydus) in the US District Court for the District of Delaware (the District Court). In May 2021, trial against Zydus proceeded in the District Court. In October 2021, the District Court issued a decision finding the asserted claims of AstraZeneca’s US Patent No. 6,515,117 as valid and infringed by Zydus’s proposed ANDA product.
Patent proceedings outside the US
In Canada, in January 2021, Sandoz Canada Inc. served
In February 2021, Teva Canada Limited served a Notice of Allegation on AstraZeneca alleging invalidity and/or non-infringement of all
F-60
Brilinta
US patent proceedings
In 2015 and subsequently, in response to Paragraph IV notices from ANDA filers, AstraZeneca filed patent infringement lawsuits in the US District Court for the District of Delaware (the District Court) relating to patents listed in the FDA Orange Book with reference to Brilinta. In 2020, AstraZeneca entered into
Roxadustat
US patent proceedings
In April 2021, Akebia Therapeutics, Inc. and Otsuka America Pharmaceutical, Inc. served AstraZeneca with a complaint seeking a declaration of invalidity and non-infringement for several of FibroGen, Inc’s (FibroGen) method of use patents related to HIF prolylhydroxylase inhibitors. AstraZeneca is the exclusive licensee of FibroGen in the United States. AstraZeneca filed a motion to dismiss in June 2021.
Patent proceedings outside the US
In Canada, in May 2018, Akebia Therapeutics, Inc. filed an impeachment action in the Federal Court of Canada alleging invalidity of several of FibroGen, Inc.’s (FibroGen) method of use patents related to HIF prolylhydroxylase inhibitors. AstraZeneca is the exclusive licensee of FibroGen in Canada. AstraZeneca and FibroGen were defending the action. The parties have resolved the action.
Symbicort
US patent proceedings
AstraZeneca is involved in ongoing ANDA litigation with Mylan Pharmaceuticals Inc. (Mylan) and Kindeva Drug Delivery L.P. (Kindeva) brought in the US District Court for the Northern District of West Virginia (the District Court). In the action, AstraZeneca alleges that the defendants' generic versions of Symbicort, if approved and marketed, would infringe various AstraZeneca patents. In September 2020, Mylan and Kindeva stipulated to patent infringement to the extent that the asserted patent claims are found to be valid and enforceable, but reserved the right to seek a vacatur of the stipulation if the US Court of Appeals for the Federal Circuit (the Federal Circuit) reverses or modifies the District Court’s claim construction. In March 2021, the District Court decided in favour of AstraZeneca and determined that the asserted patent claims were not invalid or unenforceable. Mylan and Kindeva appealed to the the Federal Circuit. In December 2021, the Federal Circuit affirmed the decision by the District Court determining that the asserted patent claims were nonobvious. However, the Federal Circuit reversed the District Court’s claim construction decision, vacated the stipulated judgment of infringement by Mylan and Kindeva and remanded the matter back to the District Court for determination of whether their ANDA product infringes the asserted patent claims under the Federal Circuit’s claim construction. In January 2022, AstraZeneca filed a Combined Petition for Panel Rehearing and Rehearing En Banc with the Federal Circuit.
Daliresp
US patent proceedings
In 2015 and subsequently, in response to Paragraph IV notices from ANDA filers, AstraZeneca filed patent infringement lawsuits in the US District Court for the District of New Jersey (the District Court) relating to patents listed in the FDA Orange Book with reference to Daliresp. In 2020, AstraZeneca entered into a settlement and the District Court entered a consent judgment to dismiss the corresponding litigation. Additional proceedings are ongoing in the District Court. No trial date has been set.
Movantik
US patent proceedings
In March 2020, Aether Therapeutics, Inc. filed a patent infringement lawsuit in the US District Court for the District of Delaware against AstraZeneca, Nektar Therapeutics and Daiichi Sankyo, Inc., relating to Movantik. A trial has been set for March 2023.
Onglyza
Patent proceedings outside the US
In Canada, in November 2019, Sandoz Canada Inc. sent a Notice of Allegation to AstraZeneca challenging the validity of Canadian substance Patent No. 2402894 (expiry March 2021) (the ‘894 patent) and formulation Patent No. 2568391 (expiry May 2025) related to Onglyza. AstraZeneca commenced an action in response related to the ‘894 patent in January 2020. In October 2021, the parties reached an agreement to resolve the dispute. This matter is now concluded.
Enhertu
US patent proceedings
In October 2020, Seagen Inc. (Seagen) filed a complaint against Daiichi Sankyo Company, Limited in the US District Court for the Eastern District of Texas alleging that Enhertu infringes US Patent No. 10,808,039 (the ‘039 patent). AstraZeneca Pharmaceuticals LP co-commercialises Enhertu with Daiichi Sankyo, Inc. (Daiichi Sankyo) in the US. In July 2021, AstraZeneca Pharmaceuticals LP and AstraZeneca UK Limited intervened in the Texas action in support of Daiichi Sankyo. A claim construction hearing took place in August 2021 and a trial has been scheduled for April 2022.
On 23 December 2020, AstraZeneca and Daiichi Sankyo filed a post-grant review petition with the US Patent and Trademark Office alleging, inter alia, that the ‘039 patent is invalid for lack of written description and enablement. In January 2021, AstraZeneca and Daiichi Sankyo filed a second post-grant review petition with the US Patent and Trademark Office extending its challenge to additional claims in the ‘039 patent. In June 2021, the US Patent and Trademark Office declined to institute the post-grant reviews. AstraZeneca and Daiichi Sankyo have requested a rehearing of their post-grant review petitions.
In August 2021, AstraZeneca Pharmaceuticals LP and Daiichi Sankyo filed an action against Andrew Hirshfeld, acting in his official capacity as Under Secretary of Commerce, and the US Patent and Trademark Office in the US District Court for the Eastern District of Virginia seeking judicial review of the US Patent Office’s discretionary authority to deny institution of post-grant review proceedings.
Ultomiris
US patent proceedings
In November 2018, Chugai Pharmaceutical Co., Ltd. (Chugai) filed a lawsuit against Alexion in the Delaware District Court alleging that Ultomiris infringes a US patent held by Chugai. Upon issuance of another US patent in November 2019, Chugai filed a second lawsuit in the same court alleging that Ultomiris also infringes the second patent. The two lawsuits were consolidated. Trial scheduled to occur in January 2022 has been postponed until February 2022 due to COVID-19.
Patent proceedings outside the US
In Japan, in December 2018, Chugai Pharmaceutical Co., Ltd (Chugai) filed a lawsuit in the Tokyo District Court against Alexion Pharma GK in Japan and alleges that Ultomiris infringes
F-61
neither valid nor infringed. In October 2021 the Japanese Patent Office invalidated
Product liability litigation
Farxiga and Xigduo XR
In several jurisdictions in the US, AstraZeneca has been named as a defendant in lawsuits involving plaintiffs claiming physical injury, including Fournier's Gangrene and necrotising fasciitis, from treatment with Farxiga and/or Xigduo XR. A majority of these claims are filed in Delaware state court and remain pending.
One case, filed in state court in Minnesota, is scheduled for trial in January 2023.
Byetta/Bydureon
In the US, Amylin Pharmaceuticals, LLC (a wholly owned subsidiary of AstraZeneca) and AstraZeneca are among multiple defendants in various lawsuits filed in federal and state courts involving claims of physical injury from treatment with Byetta and/or Bydureon. The lawsuits allege several types of injuries including pancreatic cancer and thyroid cancer. A multidistrict litigation was established in the US District Court for the Southern District of California (the District Court) in regard to the alleged pancreatic cancer cases in federal courts. Further, a coordinated proceeding has been established in Superior Court in Los Angeles, California (the California Court) in regard to the various lawsuits in California state courts. In October and December 2020, the District Court and the California Court jointly heard oral argument on renewed motions filed by Defendants seeking summary judgment and dismissal of all claims alleging pancreatic cancer. In March and April 2021, the District Court and the California Court respectively granted the Defendants’ motions, and dismissed all cases alleging pancreatic cancer with prejudice. Plaintiffs have dismissed the appeal as to Amylin Pharmaceuticals, LLC and AstraZeneca. The other claims in both courts, including those alleging thyroid cancer, remain pending.
Onglyza and Kombiglyze
In the US, AstraZeneca is defending various lawsuits alleging heart failure, cardiac injuries, and/or death from treatment with Onglyza or Kombiglyze. In February 2018, the Judicial Panel on Multidistrict Litigation ordered the transfer of various pending federal actions to the US District Court for the Eastern District of Kentucky (District Court) for consolidated pre-trial proceedings with the federal actions pending in the District Court. In the previously disclosed California State Court coordinated proceeding, AstraZeneca submitted its motion for summary judgment in December 2021.
Nexium and Losec/Prilosec
US proceedings
In the US, AstraZeneca is defending various lawsuits brought in federal and state courts involving multiple plaintiffs claiming that they have been diagnosed with various injuries following treatment with proton pump inhibitors (PPIs), including Nexium and Prilosec. The vast majority of those lawsuits relate to allegations of kidney injuries. In particular, in May 2017, counsel for a group of such plaintiffs claiming that they have been diagnosed with kidney injuries filed a motion with the Judicial Panel on Multidistrict Litigation (JPML) seeking the transfer of any currently pending federal court cases as well as any similar, subsequently filed cases to a coordinated and consolidated pre-trial multidistrict litigation (MDL) proceeding. In August 2017, the JPML granted the motion and consolidated the pending federal court cases in an MDL proceeding in federal court in New Jersey for pre-trial purposes. A trial in the MDL previously scheduled for January 2022 has been rescheduled to October 2022. In addition to the MDL cases, there are cases filed in several state courts around the US; a trial in Delaware state court previously scheduled for February 2022 is being rescheduled.
In addition, AstraZeneca has been defending lawsuits involving allegations of gastric cancer following treatment with PPIs.
Canada proceedings
In Canada, in July and August 2017, AstraZeneca was served with
Commercial litigation
Amplimmune
In the US, in June 2017, AstraZeneca was served with a lawsuit filed by the stockholders’ agents for Amplimmune, Inc. (Amplimmune) in Delaware State Court that alleged, among other things, breaches of contractual obligations relating to a 2013 merger agreement between AstraZeneca and Amplimmune. A trial of the matter was held in February 2020 and post-trial oral argument was heard in August 2020. In November 2020, the Delaware Court of Chancery decided in AstraZeneca’s favour and subsequently entered a Final Judgment as to all pending claims in favour of AstraZeneca. In December 2020, the plaintiffs filed an appeal to the Delaware Supreme Court. In October 2021, the Delaware Supreme Court affirmed the Delaware Court of Chancery’s decision. This matter is now concluded.
Array BioPharma
In December 2017, AstraZeneca was served with a complaint filed in New York State court by Array BioPharma, Inc. (Array) alleging breaches of contractual obligations relating to a 2003 collaboration agreement between AstraZeneca and Array. In June 2020, an appeal court denied AstraZeneca's motion for an early dismissal of the case, allowing the case to continue towards trial. No trial date has been set.
Ocimum lawsuit
In the US, in December 2017, AstraZeneca was served with a complaint filed by Ocimum Biosciences, Ltd. (Ocimum) in the Superior Court for the State of Delaware that alleged, among other things, breaches of contractual obligations and misappropriation of trade secrets, relating to a now terminated 2001 licensing agreement between AstraZeneca and Gene Logic, Inc. (Gene Logic), the rights to which Ocimum purports to have acquired from Gene Logic. In February 2021, the Delaware Supreme court affirmed the grant of AstraZeneca’s motion for summary judgment. This matter is now concluded.
Seroquel XR (Antitrust Litigation)
In the US in 2019, AstraZeneca was named in several related complaints brought in the US District Court for the Southern District of New York (the Court), including several putative class action lawsuits that were purportedly brought on behalf of classes of direct purchasers or end payors of Seroquel XR, that allege AstraZeneca and generic drug manufacturers violated antitrust laws when settling patent litigation related to Seroquel XR. In August 2020, the Court granted AstraZeneca’s motions to transfer all such lawsuits to the US District Court for the District of Delaware. AstraZeneca has filed motions to dismiss the complaints, which remain pending.
Anti-Terrorism Act Civil Lawsuit
In the US, in October 2017, AstraZeneca and certain other pharmaceutical and/or medical device companies were named as defendants in a complaint filed in federal court in the District of Columbia (the District Court) by US nationals (or their estates, survivors, or heirs) who were killed or wounded in Iraq between 2005 and 2013. The plaintiffs allege that the defendants violated the US Anti-Terrorism Act and various state laws by
F-62
selling pharmaceuticals and medical supplies to the Iraqi Ministry of Health. In July 2020, the District Court granted AstraZeneca’s and the other defendants’ motion and dismissed the lawsuit, and the plaintiffs appealed to the DC Circuit Court of Appeals (the Appellate Court). In January 2022, a panel of the Appellate Court reversed the dismissal and remanded the case back to the District Court. AstraZeneca and the other defendants have filed petitions requesting en banc review by the entire Appellate Court.
AZD1222 Securities Litigation
In January 2021, putative securities class action lawsuits were filed in the US District Court for the Southern District of New York against AstraZeneca PLC and certain officers, on behalf of purchasers of AstraZeneca publicly traded securities during the period 21 May 2020 through 20 November 2020. The Court appointed co-lead plaintiffs in April 2021 and they filed an Amended Complaint in July 2021 on behalf of purchasers of AstraZeneca publicly traded securities during the period 15 June 2020 through 29 January 2021. The Amended Complaint alleges that defendants made materially false and misleading statements in connection with the development of AZD1222, AstraZeneca’s vaccine for the prevention of COVID-19. In September 2021, AstraZeneca moved to dismiss the Amended Complaint.
Definiens
In Germany, in July 2020, AstraZeneca received a notice of arbitration filed with the German Institution of Arbitration from the sellers of Definiens AG (the Sellers) regarding the 2014 Share Purchase Agreement (SPA) between AstraZeneca and the Sellers. The Sellers claim they are owed approximately $
Alexion Shareholder Litigation
In March 2021, several shareholders of Alexion Pharmaceuticals, Inc. (Alexion) filed individual lawsuits against Alexion, its management, and/or AstraZeneca and affiliates in federal district court in New York. The complaints generally alleged that the preliminary registration statement filed with the SEC on 19 February 2021, omitted certain allegedly material information in connection with AstraZeneca’s proposed acquisition of Alexion (the Acquisition), and one of the complaints further alleged that the Alexion directors breached their fiduciary duties in connection with the Acquisition and that AstraZeneca and the other entity defendants aided and abetted the alleged breaches. In May 2021, all such complaints were withdrawn and dismissed. This matter is now concluded.
PARP Inhibitor Royalty Dispute
In October 2012, Tesaro, Inc. (now wholly owned by GlaxoSmithKline plc, ‘GSK’) entered into
Portola Shareholder Litigation
In connection with Alexion’s July 2020 acquisition of Portola Pharmaceuticals, Inc. (Portola), Alexion assumed litigation to which Portola is a party. In January 2020, putative securities class action lawsuits were filed in the US District Court for the Northern District of California against Portola and certain officers and directors, on behalf of purchasers of Portola publicly traded securities during the period 8 January 2019 through 26 February 2020.The third amended complaint alleges that defendants made materially false and/or misleading statements or omissions about the demand for Andexxa, usage of Andexxa by hospitals and healthcare organisations, and about Portola’s accounting for its return reserves. In August 2021, the court denied in part defendants’ motion to dismiss the case. A trial date has been set for December 2022.
Shareholder Litigation – Alexion (US)
In December 2016, putative securities class action lawsuits were filed in the US District Court for the District of Connecticut (the District Court) against Alexion and certain officers and directors, on behalf of purchasers of Alexion publicly traded securities during the period 30 January 2014 through 26 May 2017. The amended complaint alleges that defendants engaged in securities fraud, including by making misrepresentations and omissions in its public disclosures concerning Alexion’s Soliris sales practices, management changes, and related investigations. In August 2021, the District Court issued a decision denying in part Defendants’ motion to dismiss the matter.
Syntimmune
In connection with Alexion’s prior acquisition of Syntimmune, Inc., (Syntimmune) a clinical-stage biotechnology company developing an antibody therapy targeting the FcRn, in the US, in December 2020, Alexion was served with a lawsuit filed by the stockholders’ representative for Syntimmune in Delaware State Court that alleged, among other things, breaches of contractual obligations relating to the 2018 merger agreement. The stockholders’ representative alleges that Alexion failed to meet its obligations under the merger agreement to use commercially reasonable efforts to achieve the milestones, and the plaintiff has requested payment of all milestone obligations. Alexion also filed a claim for breach of the representations in the 2018 merger agreement regarding unusable drug product and drug substance that Alexion acquired from Syntimmune. Trial in the matter is scheduled for November 2022.
Government investigations/proceedings
Toprol-XL Louisiana Attorney General Litigation
In July 2020, the Louisiana First Circuit Court of Appeals (the Appellate Court) reversed and remanded a Louisiana state trial court (the Trial Court) ruling that had granted AstraZeneca’s motion for summary judgment and dismissed a state court complaint, brought by the Attorney General for the State of Louisiana (the State), alleging that AstraZeneca engaged in unlawful monopolisation and unfair trade practices in connection with the enforcement of its Toprol-XL patents. In August 2020, AstraZeneca petitioned the Louisiana Supreme Court (the Supreme Court) to review the decision of the Appellate Court and reinstate the Trial Court’s summary judgment ruling. In April 2021, the Supreme Court granted a motion to dismiss all of the State’s claims with prejudice and vacate the decisions of the Trial Court and Appellate Court. This matter is now closed.
Vermont US Attorney Investigation
In April 2020, AstraZeneca received a Civil Investigative Demand from the US Attorney’s Office in Vermont and the Department of Justice, Civil Division, seeking documents and information relating to AstraZeneca’s relationships with electronic health-record vendors. AstraZeneca is co-operating with this enquiry.
US 340B Litigations and Proceedings
AstraZeneca is involved in several matters relating to its contract pharmacy recognition policy under the 340B Drug Pricing Program in the US. In 2020,
F-63
In February 2021, AstraZeneca received a Civil Investigative Subpoena from the Attorney General’s Office for the State of Vermont seeking documents and information relating to AstraZeneca’s contract pharmacy recognition policy under the 340B Drug Pricing Program. AstraZeneca has cooperated with the inquiry.
In January 2021, AstraZeneca filed a separate lawsuit in federal court in Delaware alleging that an Advisory Opinion issued by the Department of Health and Human Services violates the Administrative Procedure Act. In June 2021, the Court found in favour of AstraZeneca, invalidating the Advisory Opinion. Prior to the Court’s ruling, however, in May 2021, the US government issued new and separate letters to AstraZeneca (and other companies) asserting that our contract pharmacy policy violates the 340B statute. In July 2021, AstraZeneca amended the complaint to include allegations challenging the letter sent in May. In September 2021, the US government issued a follow-up letter to AstraZeneca (and other companies) asserting that it has referred the matter to the Office of Inspector General for further review and consideration. In October 2021, oral arguments were held before the federal court in Delaware challenging the letters sent in May and September.
In September 2021, AstraZeneca was served with a class-action antitrust complaint filed in federal court in New York by Mosaic Health on behalf of a purported class. The complaint alleges that AstraZeneca conspired with Sanofi-Aventis U.S., LLC, Eli Lilly and Company, Lilly USA, LLC, and Novo Nordisk Inc. to restrict access to 340B discounts in the diabetes market through contract pharmacies.
US Congressional
In January 2019, AstraZeneca received a letter from the US House of Representatives Committee on Oversight and Reform (Committee) seeking information related to pricing practices for Crestor. Similar letters were sent to
European Commission Claim Regarding AZD1222
In April 2021 and May 2021, the European Commission (acting on behalf of the European Union and its member states) initiated
In September 2021, the parties reached an agreement to resolve the dispute. This matter is now concluded.
COVID-19 Vaccine Supply and Manufacturing Inquiries
In June 2021, Argentina’s Federal Criminal Prosecutor’s Office (the Prosecutor) contacted AstraZeneca Argentina seeking documents and electronic records in connection with a local criminal investigation relating to the public procurement and supply of Vaxzevria in that country. In October 2021, the Prosecutor filed a submission with the presiding court requesting dismissal of the criminal investigation. The request remains pending.
Tagrisso
In India, in June 2021, the National Pharmaceutical Pricing Authority (NPPA) issued a demand notice (Demand Notice) to AstraZeneca Pharma India Limited (AZPIL), regarding the pricing of Tagrisso. The NPPA has alleged that AZPIL has overcharged Tagrisso, claiming approximately $
Turkish Ministry of Health Matter
In Turkey, in July 2020, the Turkish Ministry of Health initiated an investigation regarding payments to healthcare providers by Alexion Turkey and former employees and consultants. The investigation arose from Alexion’s disclosure of a civil settlement with the U.S. Securities & Exchange Commission (SEC) in July 2020 fully resolving the SEC’s investigation into possible violations of the FCPA. Alexion neither admitted nor denied any wrongdoing in connection with the settlement but paid $
Canadian Pricing Matter
In October 2017, Alexion filed proceedings in the Federal Court of Canada to seek judicial review of a determination by the Canadian Patented Medicine Prices Review Board (PMPRB) that Alexion had excessively priced Soliris in a manner inconsistent with the Canadian pricing rules and guidelines. In its decision, the PMPRB ordered Alexion to decrease the price of Soliris to an upper limit based upon pricing in certain other countries and to forfeit excess revenues for the period between 2009 and 2017. In May 2019, the Federal Court dismissed Alexion’s application. Alexion appealed the decision to the Canadian Federal Court of Appeal. On 29 July 2021, the Federal Court of Appeal of Canada issued its judgment allowing the appeal, reversing the PMPRB's decision and remitting the matter to the PMPRB for re-determination with costs to AstraZeneca. In September 2021, the Attorney General of Canada sought leave to appeal the decision to the Supreme Court of Canada. Pursuant to an order made by the Federal Court of Canada, as of August 2021, AstraZeneca has placed approximately $
Brazilian Operations Investigation
In May 2017, Brazilian authorities seized records and data from Alexion’s São Paulo, Brazil offices as part of an investigation being conducted into Alexion’s Brazilian operations. AstraZeneca are cooperating with this inquiry.
Brazilian Tax Assessment Matter
In connection with an ongoing matter, in August 2019, the Brazilian Federal Revenue Service provided a Notice of Tax and Description of the Facts (the Tax Assessment) to
F-64
systems in Brazil (at this time, AstraZeneca intends to appeal the Tax Assessment if it is not overturned in the course of administrative appeals). Given the early stage of these proceedings, AstraZeneca is unable to predict the duration, scope or outcome of this matter, but we expect that a final resolution will take
Additional government inquiries
As is true for most, if not all, major prescription pharmaceutical companies, AstraZeneca is currently involved in multiple inquiries into drug marketing and pricing practices. In addition to the investigations described above, various law enforcement offices have, from time to time, requested information from the Group. There have been no material developments in those matters.
Tax
AstraZeneca considers whether it is probable that a taxation authority will accept an uncertain tax treatment. If it is concluded that it is not probable that the taxation authority will accept an uncertain tax treatment, where tax exposures can be quantified, an accrual is made based on either the most likely amount method or the expected value method depending on which method management expects to better predict the resolution of the uncertainty. Accruals can be built up over a long period of time, but the ultimate resolution of tax exposures usually occurs at a point in time, and given the inherent uncertainties in assessing the outcomes of these exposures (which sometimes can be binary in nature), we could, in future periods, experience adjustments to these accruals that have a material positive or negative effect on our results in any particular period. Details of the movements in relation to material tax exposures are discussed below.
AstraZeneca faces a number of audits and reviews in jurisdictions around the world and, in some cases, is in dispute with the tax authorities. The issues under discussion are often complex and can require many years to resolve. Accruals for tax contingencies require management to make key judgements with respect to the ultimate outcome of current and potential future tax audits, and actual results could vary from these estimates.
Transfer pricing and other international tax contingencies
The total net accrual included in the Group Financial Statements to cover the worldwide exposure to transfer pricing audits is $
Management continues to believe that AstraZeneca’s positions on all its transfer pricing and other international tax audits and disputes are robust, and that AstraZeneca is appropriately provided, including consideration of whether corresponding relief will be available under Mutual Agreement procedures or unilaterally.
HMRC communicated to the Group that they do not consider that the Group is a beneficiary of state aid following the European Commission’s (EC) decision on the state aid review of UK Controlled Foreign Company Group Financing Exemption therefore this matter is now closed.
For transfer pricing and other international tax matters where AstraZeneca and the tax authorities are in dispute, AstraZeneca estimates the potential for additional liabilities above the amount provided where the possibility of the additional liabilities falling due is more than remote, to be up to $
Other tax contingencies
Included in the tax accrual is $
For these other tax contingencies, AstraZeneca estimates the potential for additional liabilities above the amount provided where the possibility of the additional liabilities falling due is more than remote, to be up to $
Timing of cash flows and interest
It is not possible to estimate the timing of tax cash flows in relation to each outcome. It is anticipated that tax payments may be required in relation to a number of significant disputes which may be resolved over the next one to two years. AstraZeneca considers the accruals set out above to appropriately reflect the expected value of any final settlement. Some of the items discussed above are not currently within the scope of tax authority audits and may take longer to resolve.
Included within other receivables and payables is a net amount of interest arising on tax contingencies of $
31 Statutory and other information
F-65
| 2021 |
| 2020 |
| 2019 | ||
$m | $m | $m | |||||
Fees payable to PricewaterhouseCoopers LLP and its associates: |
|
|
|
|
|
| |
Group audit fee |
| |
| |
| | |
Fees payable to PricewaterhouseCoopers LLP and its associates for other services: |
|
|
| ||||
The audit of subsidiaries pursuant to legislation |
| |
| |
| | |
Attestation under s404 of Sarbanes-Oxley Act 2002 | | | | ||||
Audit-related assurance services |
| |
| |
| | |
Other assurance services |
| |
| |
| | |
Fees payable to PricewaterhouseCoopers Associates in respect of the Group’s pension schemes: |
|
|
| ||||
The audit of subsidiaries’ pension schemes |
| |
| |
| | |
| |
| |
| |
$
$
Included in Audit-related and Other assurance services are $
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.
Key management personnel compensation
Key management personnel are defined for the purpose of disclosure under IAS 24 ‘Related Party Disclosures’ as the members of the Board and the members of the SET.
| 2021 |
| 2020 |
| 2019 |
| |
$’000 | $’000 | $’000 |
| ||||
Short-term employee benefits |
| |
| |
| | |
Post-employment benefits |
| |
| |
| | |
Share-based payments |
| |
| |
| | |
| |
| |
| |
Total remuneration is included within employee costs (see Note 29).
32 Subsequent events
On 4 January 2022, AstraZeneca completed the sale of the global rights to Tudorza and Duaklir to Covis Pharma GmbH for an upfront payment of $
Group Subsidiaries and Holdings
In accordance with section 409 of the Companies Act 2006 a full list of subsidiaries, partnerships, associates, joint ventures and joint arrangements, the country of incorporation, registered office address, and the effective percentage of equity owned as at 31 December 2021 are disclosed below. Unless otherwise stated the share capital disclosed comprises ordinary shares which are indirectly held by AstraZeneca PLC.
Unless otherwise stated the accounting year ends of subsidiaries are 31 December. The Group Financial Statements consolidate the Financial Statements of the Company and its subsidiaries at 31 December 2021.
At 31 December 2021 |
| Group Interest |
|
Wholly owned subsidiaries |
|
| |
Algeria | |||
AAPM Sarl | | % | |
20 Zone Macro-Economique, Hydra, Dar El Medina, Algiers, Algeria | |||
Argentina |
|
| |
AstraZeneca S.A. |
| | % |
Nicolas de Vedia 3616, Piso 8, Ciudad Autónoma de Buenos Aires, Argentina |
|
| |
Alexion Pharma Argentina SRL | | % | |
Avenida Leandro N. Alem 592 Piso 6, Buenos Aires, Argentina | |||
Australia |
|
| |
AstraZeneca Holdings Pty Limited |
| | % |
AstraZeneca PTY Limited |
| | % |
66 Talavera Road, Macquarie Park, NSW 2113, Australia |
|
| |
Alexion Pharmaceuticals Australasia Pty Ltd | | % |
Building A Suite 401 Level 4, 20 Rodborough Road, Frenchs Forest, NSW 2086, Australia | |||
|
| ||
Austria |
| ||
AstraZeneca Österreich GmbH |
| | % |
Landstraßer Hauptstraße 1A, A-1030 Wien, Österreich |
| ||
Alexion Pharma Austria GmbH | | % | |
Donau-City-Straße 7, 30. Stock, DC Tower Vienna 1220, Austria | |||
| |||
Belgium |
|
| |
AstraZeneca S.A. / N.V. |
| | % |
Alfons Gossetlaan 40 bus 201 at 1702 Groot-Bijgaarden, Belgium |
| ||
Alexion Pharma Belgium Sprl | | % | |
Alexion Services Europe Srl | | % | |
de Meeûssquare 37 Bruxelles 1000 Belgium | |||
Bermuda | |||
Alexion Bermuda Holding ULC | % | ||
Alexion Bermuda Limited | % | ||
Canon's Court, 22 Victoria St., Hamilton, Bermuda | |||
|
|
Brazil |
|
| |
AstraZeneca do Brasil Limitada |
| | % |
Rod. Raposo Tavares, KM 26, 9, Cotia, Brazil |
|
| |
Alexion Farmacêutica América Latina Serviços de Administração de Vendas Ltda. | | % | |
Avenida Doutor Chucri Zaidan, 1240 pavimento 18 Conj 1801 parte Edif. Morumbi Golden Tower Torre A Vila Sao Francisco, Sao Paulo 04530-000 Brazil | |||
Alexion Farmacêutica Brasil Importação e Distribuição de Produtos e Serviços de Administração de Vendas Ltda | | % | |
Avenida Dr. Chucri Zaidan, 1240, 15th floor, Morumbi Corporate Golden Tower, São Paulo, SP, 04711-130, Brazil | |||
|
| ||
Bulgaria |
| ||
AstraZeneca Bulgaria EOOD |
| | % |
36 Dragan Tzankov Blvd., District Izgrev, Sofia, 1057, Bulgaria |
| ||
|
F-66
Canada |
|
| |
AstraZeneca Canada Inc.1 |
| | % |
Suite 5000, 1004 Middlegate Road, Ontario, L4Y 1M4, Canada |
| ||
Alexion Pharma Canada Corporation | % | ||
1300-1969 ST, Upper Water, Halifax, NS B3J3R7, Canada | |||
| |||
Cayman Islands |
|
| |
AZ Reinsurance Limited |
| | % |
18 Forum Lane, 2nd Floor, Camana Bay, Grand Cayman, P.O. BOX 69, Cayman Islands |
| ||
|
| ||
Chile |
| ||
AstraZeneca S.A. |
| | % |
AstraZeneca Farmaceutica Chile Limitada |
| | % |
Av. Isidora Goyenechea 3477, 2nd Floor, Las Condes, Santiago, Chile |
|
| |
| |||
China |
|
| |
AstraZeneca Pharmaceuticals Co., Limited |
| | % |
No. 2, Huangshan Road, Wuxi, Jiangsu Province, China |
| ||
AstraZeneca (Wuxi) Trading Co. Ltd |
| | % |
Building E, Huirong Plaza, Jinghui Road East, Xinwu District, Wuxi, Jiangsu Province, China |
| ||
AstraZeneca Investment (China) Co., Ltd |
| | % |
199 Liangjing Road, China (Shanghai) Pilot Free Trade Zone, Shanghai, China |
|
| |
AstraZeneca Pharmaceutical (China) Co. Ltd |
| | % |
No. 9 Medical Avenue, Jiangsu Province, Taizhou, China |
|
| |
AstraZeneca Pharmaceutical (Beijing) Co., Ltd |
| | % |
1F, Building No.4, No.8 Courtyard, No.1 Kegu Street, Beijing Economic-Technological Development Area, Beijing 100176, China |
| ||
AstraZeneca (Guangzhou) Pharmaceutical Consulting Co., Ltd. | | % | |
Room 406-178, No. 1, Yichuang Street, (China-Singapore Guangzhou Knowledge City) Huangpu District, Guangzhou City, China | |||
AstraZeneca Investment Consulting (Wuxi) Co., Ltd | | % | |
Room 808, 8F, Building 99-2 Linghu Avenue, Xinwu District, Wuxi, Jiangsu, China | |||
AstraZeneca Pharmaceutical (Hangzhou) Co., Ltd | | % | |
12F & 14F, Building 1, Shuli Plaza, 758 Fei Jia Tang Road, Gongshu District, Hangzhou, Zhejiang Province, China | |||
AstraZeneca Global R&D (China) Co., Ltd | | % | |
16F, 88 Xizang North Road, Jing’an District, Shanghai, China | |||
AstraZeneca Pharmaceutical (Chengdu) Co., Ltd. | | % | |
10th Floor, Building 11 (Building E11), No. 366, Hemin Street, Chengdu High-tech Zone, China (Sichuan) Pilot Free Trade Zone | |||
AstraZeneca Pharmaceutical (Shanghai) Co., Ltd | | % | |
B1F, 8F & 9F, 88 Xizang North Road, Jing’an District, Shanghai, China | |||
Alexion Pharmaceuticals (Shanghai) Company Limited | | % | |
Room 702, Level, No. 1539 West Nanjing Road, Jing'an District, Shangai, China |
|
| |
Colombia |
|
| |
AstraZeneca Colombia S.A.S. |
| | % |
Carrera 7 No. 71-21, Torre A, Piso 19, Bogota, D.C., Colombia |
|
| |
Alexion Pharma Colombia S.A.S. | | % | |
Carrera 9 No. 115 - 06 /30 Edificio Tierra Firme Oficina 2904 Bogota D.C., Colombia | |||
Costa Rica |
|
| |
AstraZeneca CAMCAR Costa Rica, S.A. |
| | % |
Escazu, Guachipelin, Centro Corporativo Plaza Roble, Edificio Los Balcones, Segundo Nivel, San Jose, Costa Rica |
|
| |
Croatia |
|
| |
AstraZeneca d.o.o. |
| | % |
Radnicka cesta 80, 10000 Zagreb, Croatia |
|
| |
Czech Republic |
| ||
AstraZeneca Czech Republic, s.r.o. |
| | % |
U Trezorky 921/2, 158 00 Prague 5, Czech Republic |
| ||
Alexion Pharma Czech s.r.o. | | % | |
Novodvorská 994/138, Braník, 142 00 Prague, Czech Republic | |||
Denmark |
|
| |
AstraZeneca A/S |
| | % |
World Trade Center Ballerup, Borupvang 3, DK- 2750 Ballerup, Denmark |
| ||
Egypt |
|
| |
AstraZeneca Egypt for Pharmaceutical Industries SAE |
| | % |
6th of October City, 6th Industrial Zone, Plot 2, Giza, Egypt |
| ||
AstraZeneca Egypt LLC |
| | % |
47 St. 270 New Maadi, Maddi, Cairo, Egypt |
|
| |
Drimex LLC |
| | % |
Plot 133, Banks’ District, 5th Settlement, New Cairo, Cairo, Egypt |
| ||
Estonia |
| ||
AstraZeneca Eesti OÜ |
| | % |
Valukoja 8, Ülemiste City, Tallinn 11415, Estonia |
| ||
Finland |
|
| |
AstraZeneca OY. |
| | % |
Itsehallintokuja 4, Espoo, 02600, Finland |
| ||
France |
| ||
AstraZeneca S.A.S. |
| | % |
Tour Carpe Diem-31, Place des Corolles, 92400 Courbevoie, France |
| ||
AstraZeneca Dunkerque Production SCS |
| | % |
224 Avenue de la Dordogne, 59640 Dunkerque, France |
| ||
AstraZeneca Reims Production | | % | |
Chemin de Vrilly Parc, Industriel de la Pompelle, 51100, Reims, France | |||
Alexion Europe S.A.S. | | % | |
Alexion Pharma France S.A.S. | | % | |
103-105 Rue Anatole France 92300 Levallois-Perret | |||
Germany |
| ||
AstraZeneca Holding GmbH |
| | % |
AstraZeneca GmbH |
| | % |
Tinsdaler Weg 183, Wedel, D-22880, Germany |
| ||
Sofotec GmbH |
| | % |
Benzstrasse 1-3, 61352, Bad Homburg v.d. Hohe, Germany |
| ||
AstraZeneca Computational Pathology GmbH2 |
| | % |
Bernhard-Wicki-Straße 5, 80636, Munich, Germany |
|
Portola FRG GmbH | | % | |
Fraunhoferstraβe 12 Planegg 82152 Germany | |||
Alexion Pharma Germany GmbH | | % | |
Landsberger Straße 300, 80687 Munich, Germany | |||
Greece |
|
| |
AstraZeneca S.A. |
| | % |
Agisilaou 6-8 str., Marousi-Athens, 15123, Greece |
|
| |
Hong Kong |
|
| |
AstraZeneca Hong Kong Limited |
| | % |
Unit 1 – 3, 11/F., 18 King Wah Road, North Point, Hong Kong |
|
| |
Hungary |
|
| |
AstraZeneca Kft |
| | % |
1st floor, 4 building B, Alíz str., Budapest, 1117, Hungary |
|
| |
India |
|
| |
AstraZeneca India Private Limited3 |
| | % |
Block A, Neville Tower, 11th Floor, Ramanujan IT SEZ, Taramani, Chennai, Tamil Nadu, PIN 600113, India |
|
| |
Alexion Business Services Private Limited | | % | |
9th Floor, Platina, G Block Plot No. C-59, Bandra-Kurla Complex Bandra (East), Mumbai 400051 India | |||
Iran |
|
| |
AstraZeneca Pars Company |
| | % |
Suite 1, 1st Floor No. 39, Alvand Ave., Argantin Sq., Tehran 1516673114, Iran |
| ||
Ireland |
|
| |
AstraZeneca Pharmaceuticals (Ireland) Designated Activity Company |
| | % |
4th Floor, South Bank House, Barrow Street, Dublin, 4, Republic of Ireland |
| ||
Alexion Pharma Holding UC | % | ||
Alexion Pharma International Operations UC | % | ||
Alexion Pharma Development UC | % | ||
College Business & Technology Park Blanchardstown Road North Dublin 15 Ireland | |||
Israel |
|
| |
AstraZeneca (Israel) Ltd |
| | % |
6 Hacharash St., Hod Hasharon, 4524075, Israel |
| ||
Alexion Pharma Israel Ltd | % | ||
4 Weizmann Str., Tel-Aviv-Jaffa, Israel | |||
Italy |
|
| |
Simesa SpA |
| | % |
AstraZeneca SpA |
| | % |
Viale Decumano 39 20157 Milan, Italy |
|
| |
Alexion Pharma Italy Srl | | % | |
Via Melchiorre Gioia 8 Milano 20124, Italy | |||
Japan |
|
| |
AstraZeneca K.K. |
| | % |
Grand Front Osaka Tower B, 3-1, Ofuka-cho, Kita-ku, Osaka, 530-0011, Japan |
|
| |
Alexion Pharma GK | | % | |
Ebisu First Square, 18-14, Ebisu 1-chome, Shibuya-ku, Tokyo, Japan | |||
Kenya |
|
| |
AstraZeneca Pharmaceuticals Limited |
| | % |
L.R. No.1/1327, Avenue 5, 1st Floor, Rose Avenue, Nairobi, Kenya |
|
|
F-67
Latvia |
|
| |
AstraZeneca Latvija SIA |
| | % |
Skanstes iela 50, Riga, LV-1013, Latvia |
|
| |
Lithuania |
| ||
AstraZeneca Lietuva UAB |
| | % |
Spaudos g., Vilnius, LT-05132, Lithuania |
|
| |
Luxembourg |
| ||
AstraZeneca Luxembourg S.A. |
| | % |
Rue Nicolas Bové 2A – L-1253 Luxembourg |
| ||
Malaysia |
|
| |
AstraZeneca Asia-Pacific Business Services Sdn Bhd |
| | % |
12th Floor, Menara Symphony, No 5 Jalan Prof, Khoo Kay Kim, Seksyen 13, 46200 Petaling Jaya, Selangor Darul Ehsan, Malaysia |
| ||
AstraZeneca Sdn Bhd |
| | % |
Nucleus Tower, Level 11 & 12, No. 10 Jalan PJU 7/6, Mutiara Damansara, 47800 Petaling Jaya, Selangor Darul Ehsan, Malaysia |
|
| |
Mexico |
| ||
AstraZeneca Health Care Division, S.A. de C.V. |
| | % |
AstraZeneca, S.A. de C.V. |
| | % |
Av. Periferico Sur 4305 interior 5, Colonia Jardines en la Montaña, Mexico City, Tlalpan Distrito Federal, CP 14210, Mexico |
| ||
Alexion Pharma Mexico S. de R.L. de C.V. | | % | |
Paseo de los Tamarindos 90 Torre 1 piso 6 - A Col. Bosques de la Lomas CP 05120 D.F Mexico | |||
Morocco |
| ||
AstraZeneca Maroc SARLAU |
| | % |
92 Boulevard Anfa ETG 2, Casablanca 20000, Morocco |
| ||
The Netherlands |
| ||
AstraZeneca B.V. |
| | % |
AstraZeneca Continent B.V. |
| | % |
AstraZeneca Gamma B.V. |
| | % |
AstraZeneca Holdings B.V. |
| | % |
AstraZeneca Jota B.V. |
| | % |
AstraZeneca Rho B.V. |
| | % |
AstraZeneca Sigma B.V. |
| | % |
AstraZeneca Treasury B.V. |
| | % |
AstraZeneca Zeta B.V. |
| | % |
Alexion Holding B.V. |
| % | |
Alexion Pharma Foreign Holdings, B.V. |
| | % |
Prinses Beatrixlaan 582, 2595BM, The Hague, The Netherlands |
| ||
AstraZeneca Nijmegen B.V. | | % | |
Lagelandseweg 78, 6545 CG Nijmegen, The Netherlands | |||
Acerta Pharma B.V. | % | ||
Aspire Therapeutics B.V. | | % | |
Kloosterstraat 9, 5349 AB, Oss, The Netherlands | |||
Portola Netherlands B.V. | | % | |
Prins Bernhardplein 200 JB Amsterdam 1097, The Netherlands | |||
Alexion Pharma Netherlands B.V. | % | ||
Herengracht 282 Amsterdam 1016 BX, The Netherlands |
At 31 December 2021 |
| Group Interest |
|
New Zealand |
|
| |
AstraZeneca Limited |
| | % |
Pharmacy Retailing (NZ) Limited t/a Healthcare Logistics, 58 Richard Pearse Drive, Mangere, Auckland, 1142, New Zealand |
|
|
Nigeria |
|
| |
AstraZeneca Nigeria Limited |
| | % |
11A, Alfred Olaiya Street, Awuse Estate, Off Salvation Street, Opebi, Ikeja, Lagos, Nigeria |
|
| |
Norway |
|
| |
AstraZeneca AS |
| | % |
Fredrik Selmers vei 6 NO-0663 Oslo, Norway |
|
| |
Pakistan |
|
| |
AstraZeneca Pharmaceuticals Pakistan (Private) Limited4 |
| | % |
Office No. 1, 2nd Floor, Sasi Arcade, Block 7, Main Clifton Road, Karachi, Pakistan |
|
| |
Panama |
|
| |
AstraZeneca CAMCAR, S.A. |
| | % |
Bodega #1, Parque Logistico MIT, Carretera Hacia Coco Solo, Colon, Panama |
|
| |
Peru |
|
| |
AstraZeneca Peru S.A. |
| | % |
Calle Las Orquídeas No. 675, Int. 802, Edificio Pacific Tower, San Isidro, Lima, Peru |
|
| |
Philippines |
|
| |
AstraZeneca Pharmaceuticals (Phils.) Inc. |
| | % |
16th Floor, Inoza Tower, 40th Street, Bonifacio Global City, Taguig 1634, Philippines |
|
| |
Poland |
|
| |
AstraZeneca Pharma Poland Sp.z.o.o. |
| | % |
Postepu 14, 02-676, Warszawa, Poland |
|
| |
Portugal |
|
| |
Astra Alpha Produtos Farmaceuticos Lda |
| | % |
AstraZeneca Produtos Farmaceuticos Lda |
| | % |
Novastra Promoção e Comércio Farmacêutico Lda |
| | % |
Novastuart Produtos Farmaceuticos Lda |
| | % |
Stuart-Produtos Farmacêuticos Lda |
| | % |
Zeneca Epsilon – Produtos Farmacêuticos Lda |
| | % |
Zenecapharma Produtos Farmaceuticos, Unipessoal Lda |
| | % |
Rua Humberto Madeira, No 7, Queluz de Baixo, 2730-097, Barcarena, Portugal |
|
| |
Puerto Rico |
|
| |
IPR Pharmaceuticals, Inc. |
| | % |
Road 188, San Isidro Industrial Park, Canóvanas, Puerto Rico 00729 |
|
| |
Romania |
|
| |
AstraZeneca Pharma S.R.L. |
| | % |
12 Menuetului Street, Bucharest Business Park, Building D, West Wing, 1st Floor, Sector 1, Bucharest, 013713, Romania |
|
| |
Russia |
|
| |
AstraZeneca Industries, LLC |
| | % |
249006, 1st Vostochniy proyezd, 8, Dobrino village, Borovskiy district, Russian Federation | |||
AstraZeneca Pharmaceuticals, LLC |
| | % |
Building 1, 21 First Krasnogvardeyskiy lane, floor 30, Moscow, Russia |
|
| |
Alexion Pharma OOO LLC | | % | |
4th Lesnoy Pereulok, Floor 5, Office 529, Moscow, 125047, Russian Federation. | |||
Singapore |
|
| |
AstraZeneca Singapore Pte Limited |
| | % |
10 Kallang Avenue #12-10, Aperia Tower 2, 339510, Singapore |
|
| |
South Africa |
|
| |
AstraZeneca Pharmaceuticals (Pty) Limited |
| | % |
17 Georgian Crescent West, Northdowns Office Park, Bryanston, 2191, South Africa |
|
| |
South Korea |
|
| |
AstraZeneca Korea Co. Ltd |
| | % |
21st Floor, Asem Tower, 517, Yeongdong-daero, Gangnam-gu, Seoul, 06164, South Korea |
|
| |
Alexion Pharma Korea LLC | | % | |
41 FL., 152 Teheran-ro (Yeoksam-dong Gangnam Finance Center), Gangnam-gu Seoul, South Korea | |||
Spain |
|
| |
AstraZeneca Farmaceutica Holding Spain, S.A. |
| | % |
AstraZeneca Farmaceutica Spain S.A. |
| | % |
Fundación AstraZeneca | | % | |
Laboratorio Beta, S.A. |
| | % |
Laboratorio Lailan, S.A. |
| | % |
Laboratorio Tau S.A. |
| | % |
Parque Norte, Edificio Álamo, C/Serrano Galvache no 56., 28033 Madrid, Spain |
|
| |
Alexion Pharma Spain S.L. | | % | |
Av Diagonal Num. 601 P.1 Barcelona 08028, Spain | |||
Sweden |
|
| |
Astra Export & Trading Aktiebolag |
| | % |
Astra Lakemedel Aktiebolag |
| | % |
AstraZeneca AB |
| | % |
AstraZeneca Biotech AB |
| | % |
AstraZeneca BioVentureHub AB |
| | % |
AstraZeneca Holding Aktiebolag5 |
| | % |
AstraZeneca International Holdings Aktiebolag6 |
| | % |
AstraZeneca Nordic AB |
| | % |
AstraZeneca Pharmaceuticals Aktiebolag |
| | % |
AstraZeneca Södertälje 2 AB |
| | % |
Stuart Pharma Aktiebolag |
| | % |
Tika Lakemedel Aktiebolag |
| | % |
SE-151 85 Södertälje, Sweden |
|
| |
Aktiebolaget Hassle |
| | % |
Symbicom Aktiebolag6 |
| | % |
431 83 MoIndal, Sweden |
|
| |
Astra Tech International Aktiebolag |
| | % |
Box 14, 431 21 MoIndal, Sweden |
|
| |
Alexion Pharma Nordics Holding AB | | % | |
Alexion Pharma Nordics AB | | % | |
TTM Europe Development AB | | % | |
Wilson Therapeutics AB | | % | |
Wilson Therapeutics Incentive AB | | % | |
Kungsgatan 3, 111 43 Stockholm, Sweden | |||
Switzerland |
|
| |
AstraZeneca AG |
| | % |
Neuhofstrasse 34, 6340 Baar, Switzerland |
|
| |
Spirogen Sarl6 |
| | % |
Rue du Grand-Chêne 5, CH-1003 Lausanne, Switzerland |
|
| |
Portola Schweiz GmbH | | % | |
c/o Tom Schaffner Schärer Rechtsanwälte Hintere Bahnhofstrasse 6, 5000 Aarau, Switzerland | |||
Alexion Pharma GmbH | | % | |
Giesshübelstrasse 30, Zürich, 8045, Switzerland | |||
F-68
Taiwan |
|
| |
AstraZeneca Taiwan Limited |
| | % |
21st Floor, Taipei Metro Building 207, Tun Hwa South Road, SEC 2 Taipei, Taiwan |
|
| |
Alexion Pharma Taiwan Ltd | | % | |
Room 1153, 11F, No.1, SongZhi Rd Taipei, 11047 Taiwan | |||
Thailand |
|
| |
AstraZeneca (Thailand) Limited |
| | % |
Asia Centre 19th floor, 173/20, South Sathorn Rd, Khwaeng Thungmahamek, Khet Sathorn, Bangkok, 10120, Thailand |
|
| |
Tunisia |
|
| |
AstraZeneca Tunisie SaRL |
| | % |
Lot No.11.5.5 les jardins du lac, bloc B les berges du lac Tunis, Tunisia |
|
| |
Turkey |
|
| |
AstraZeneca Ilac Sanayi ve Ticaret Limited Sirketi |
| | % |
YKB Plaza, B Blok, Kat:3-4, Levent/Beşiktaş, Istanbul, Turkey |
|
| |
Zeneca Ilac Sanayi Ve Ticaret Anonim Sirketi |
| | % |
Büyükdere Cad., Y.K.B. Plaza, B Blok, Kat:4, Levent/Beşiktaş, Istanbul, Turkey |
|
| |
Alexion Ilac Ticaret Limited Sirketi | | % | |
İçerenköy Mahallesi Umut Sok. AND Ofis Sit. No. 1012/73 Ataşehir Istanbul Turkey | |||
Ukraine |
|
| |
AstraZeneca Ukraina LLC |
| | % |
54 Simi Prakhovykh street, Kiev, 01033, Ukraine |
|
| |
United Arab Emirates |
|
| |
AstraZeneca FZ-LLC |
| | % |
P.O. Box 505070, Block D, Dubai Healthcare City, Oud Mehta Road, Dubai, United Arab Emirates |
|
| |
Alexion Pharma Middle East FZ-LLC | | % | |
Dubai Science Park, 501, Floor 5, EIB Building No. 2, Dubai, United Arab Emirates | |||
United Kingdom |
|
| |
Ardea Biosciences Limited |
| | % |
Arrow Therapeutics Limited |
| | % |
Astra Pharmaceuticals Limited |
| | % |
AstraPharm6 |
| | % |
AstraZeneca China UK Limited |
| | % |
AstraZeneca Death In Service Trustee Limited |
| | % |
AstraZeneca Employee Share Trust Limited |
| | % |
AstraZeneca Finance Limited |
| | % |
AstraZeneca Intermediate Holdings Limited5 |
| | % |
AstraZeneca Investments Limited |
| | % |
AstraZeneca Japan Limited |
| | % |
AstraZeneca Nominees Limited |
| | % |
AstraZeneca Quest Limited |
| | % |
AstraZeneca Share Trust Limited |
| | % |
AstraZeneca Sweden Investments Limited |
| | % |
AstraZeneca Treasury Limited6 |
| | % |
AstraZeneca UK Limited |
| | % |
AstraZeneca US Investments Limited5 |
| | % |
AZENCO2 Limited |
| | % |
AZENCO4 Limited |
| | % |
Cambridge Antibody Technology Group Limited |
| | % |
KuDOS Horsham Limited |
| | % |
KuDOS Pharmaceuticals Limited |
| | % |
Zenco (No. 8) Limited |
| | % |
Zeneca Finance (Netherlands) Company |
| | % |
1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, CB2 0AA, United Kingdom |
|
| |
MedImmune Limited |
| | % |
Milstein Building, Granta Park, Cambridge, CB21 6GH, United Kingdom |
|
| |
MedImmune U.K. Limited |
| | % |
Plot 6, Renaissance Way, Boulevard Industry Park, Liverpool, L24 9JW, United Kingdom |
|
| |
Syntimmune Limited | | % | |
21 Holborn Viaduct, London, EC1A 2DY, United Kingdom | |||
Alexion Pharma UK Limited | | % | |
Portola Pharma UK Limited | | % | |
3 Furzeground Way, Stockley Park Uxbridge Middlesex, UB11 1EZ, United Kingdom | |||
United States |
|
| |
Amylin Ohio LLC7 | | % | |
Amylin Pharmaceuticals, LLC7 |
| | % |
AstraZeneca Collaboration Ventures, LLC7 |
| | % |
AstraZeneca Pharmaceuticals LP8 |
| | % |
Atkemix Nine Inc. |
| | % |
Atkemix Ten Inc. |
| | % |
BMS Holdco, Inc. |
| | % |
Corpus Christi Holdings Inc. |
| | % |
Omthera Pharmaceuticals, Inc. |
| | % |
Optein, Inc. | | % | |
Stauffer Management Company LLC7 |
| | % |
Zeneca Holdings Inc. |
| | % |
Zeneca Inc. |
| | % |
Zeneca Wilmington Inc.5 |
| | % |
AstraZeneca Finance LLC | | % | |
AstraZeneca Finance and Holdings Inc.5 | | % | |
1800 Concord Pike, Wilmington, DE 19803, United States |
|
| |
ZS Pharma Inc. |
| | % |
1100 Park Place, Suite 300, San Mateo, CA 94403, United States |
|
| |
AlphaCore Pharma, LLC7 |
| | % |
333 Parkland Plaza, Suite 5, Ann Arbor, MI 48103, United States |
|
| |
AZ-Mont Insurance Company |
| | % |
76 St Paul Street, Suite 500, Burlington, VT 05401, United States |
|
| |
Definiens Inc. |
| | % |
1808 Aston Avenue, Suite 190, Carlsbad, CA 92008, United States |
|
| |
MedImmune, LLC7 |
| | % |
MedImmune Ventures, Inc. |
| | % |
One MedImmune Way, Gaithersburg, MD 20878, United States |
|
| |
Pearl Therapeutics, Inc. |
| | % |
200 Cardinal Way, Redwood City, CA 94063, United States |
|
| |
Caelum Biosciences Inc. | | % | |
1200 Florence Columbus Road, Bordentown, NJ 08505, United States | |||
Alexion Services Latin America Inc. | | % | |
600 Brickell Ave, Miami, FL 33131, United States | |||
Portola USA, Inc. | | % | |
Portola Pharmaceuticals LLC | | % | |
270 East Grand Avenue South San Francisco, CA 94080, United States | |||
Achillion Pharmaceuticals, Inc. | | % | |
Alexion Delaware Holding LLC | | % | |
Alexion Holding LLC | | % | |
Alexion Pharma LLC | | % | |
Alexion Pharmaceuticals, Inc. | | % | |
Syntimmune, Inc. | | % | |
Alexion US Holdings LLC | | % | |
Alexion US1 LLC | | % | |
Savoy Therapeutics Corp | | % | |
Wilson Therapeutics USA, Inc. | | % |
121 Seaport Boulevard, Boston, MA 02210, United States | |||
Acerta Pharma LLC7 | | % | |
121 Oyster Point Boulevard, South San Francisco, CA 94080, United States | |||
Cider Merger Sub, Inc. | | % | |
1209 Orange Street, City of Wilmington, County of New Castle, Delaware 19801, United States |
At 31 December 2021 |
| Group Interest |
|
Uruguay |
|
| |
AstraZeneca S.A. |
| | % |
Yaguarón 1407 of 1205, 11.100, Montevideo, Uruguay |
|
| |
Venezuela |
|
| |
AstraZeneca Venezuela S.A. |
| | % |
Gotland Pharma S.A. |
| | % |
Av. La Castellana, Torre La Castellana, Piso 5, Oficina 5-G, 5-H, 5-I, Urbanización La Castellana, Municipio Chacao, Estado Bolivariano de Miranda, Venezuela |
|
| |
Vietnam |
|
| |
AstraZeneca Vietnam Company Limited |
| | % |
18th Floor, A&B Tower, 76 Le Lai, Ben Thanh Ward, District 1, Ho Chi Minh City, Vietnam |
|
| |
Subsidiaries where the effective interest is less than 100% |
| ||
India |
|
| |
AstraZeneca Pharma India Limited3 |
| | % |
Block N1, 12th Floor, Manyata Embassy Business Park, Rachenahalli, Outer Ring Road, Bangalore-560 045, India |
|
| |
Indonesia |
|
| |
P.T. AstraZeneca Indonesia |
| | % |
Perkantoran Hijau Arkadia Tower F, 3rd Floor, JI. T.B. Simatupang Kav. 88, Jakarta, 12520, Indonesia |
|
| |
Joint Ventures |
|
| |
Hong Kong |
|
| |
WuXi MedImmune Biopharmaceutical Co., Limited |
| | % |
Room 1902, 19/F, Lee Garden One, 33 Hysan Avenue, Causeway Bay, Hong Kong | |||
IHP HK Holdings Limited | | % | |
Unit 5805, 58/F., Two International Finance Centre 8 Finance Street, Central, Hong Kong |
|
| |
United Kingdom |
|
| |
Archigen Biotech Limited9 |
| | % |
Centus Biotherapeutics Limited9 |
| | % |
1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, CB2 0AA, United Kingdom |
|
| |
United States |
|
| |
Montrose Chemical Corporation of California |
| | % |
Suite 380, 600 Ericksen Ave N/E, Bainbridge Island, United States |
|
| |
Significant Holdings |
|
| |
Australia |
|
| |
Armaron Bio Ltd10 |
| | % |
MPR Group, HWT Tower, Level 19, 40 City Rd, Southbank, VIC 3006, Australia |
|
| |
China |
|
| |
Dizal (Jiangsu) Pharmaceutical Co., Ltd.11 |
| | % |
F-69
199 Liangjing Rd, Zhangjiang Hi-Tech Park, Pudong District, Shanghai, China, 201203 | |||
Wuxi AstraZeneca-CICC Venture Capital Partnership (Limited Partnership) | | % | |
Room 808, 8F, Building 99-2 Linghu Avenue, Xinwu District, Wuxi, Jiangsu, China |
|
| |
United Kingdom |
|
| |
Apollo Therapeutics LLP7 |
| | % |
Stevenage Biosciences Catalyst, Gunnels Wood Road, Stevenage, Hertfordshire, SG1 2FX, United Kingdom |
|
| |
VaxEquity14 | | % | |
The Mansion, Chesterford Research Park, Little Chesterford, Essex, United Kingdom CB10 1XL | |||
United States |
|
| |
C.C. Global Chemicals Company8 |
| | % |
PO Box 7, MS2901, Texas, TX76101-0007, United States |
|
| |
Associated Holdings |
|
| |
France | |||
Medetia SAS9 | | % | |
Institute Imagine 24, Boulevard du Montparnasse 75015, Paris, France | |||
Sweden |
|
| |
Swedish Orphan Biovitrum AB (publ) |
| | % |
Tomtebodavägen 23A, Stockholm, Sweden |
|
| |
Ondosis6 | | % | |
BioVentureHub, Pepparedsleden 1, 431 83 Mölndal, Sweden | |||
United Kingdom |
|
| |
Circassia Pharmaceuticals PLC |
| | % |
Northbrook House, Robert Robinson Avenue, Oxford Science Park, Oxford, OX4 4GA, United Kingdom |
|
| |
United States |
|
| |
AbMed Corporation12 |
| | % |
68 Cummings Park Drive, Woburn, MA 01801, United States |
|
| |
Aristea Therapeutics, Inc.13 |
| | % |
122770 High Bluff Drive, #380, San Diego, CA 92130, United States |
|
| |
Baergic Bio, Inc. |
| | % |
2 Gansevoort Street, 9th Floor, New York, NY 10014, United States |
|
| |
Employee Benefit Trust | |||
The AstraZeneca Employee Benefit Trust |
| 1 | Ownership held in ordinary and class B special shares. |
| 2 | Ownership held in common shares, preferred shares 2003, preferred shares 2003 ex (A), preferred shares 2003 ex (B), preferred shares Series D, preferred shares Series E and preferred shares Series F. |
| 3 | Accounting year end is 31 March. |
| 4 | Accounting year end is 30 June. |
| 5 | Directly held by AstraZeneca PLC. |
| 6 | Ownership held in Ordinary A shares and Ordinary B shares. |
| 7 | Ownership held as membership interest. |
| 8 | Ownership held as partnership interest. |
| 9 | Ownership held in class A preference shares. |
| 10 | Ownership held in class B preference shares. |
| 11 | Voting rights and percentages vary depending on the subject matter and business to be voted on. |
| 12 | Ownership held in common shares and series A preferred shares. |
| 13 | Ownership held in series A-1 preferred stock and series B preferred stock. |
| 14 | Ownership held in series A preferred stock. |
F-70
F-71