ASTRAZENECA PLC
For the period ended Dec 31, 2023. Filed Feb 20, 2024.
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The yearly report of a company based outside the US. It covers much of what a 10-K does, and may follow accounting rules other than US ones.
FY2023 · Filed Feb 20, 2024
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM** **20-F
(Mark One)
| ☐ | REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 |
|---|---|
| OR | |
| ☒ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended December 31, 2023 |
| OR | |
| ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| OR | |
| ☐ | SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Date of event requiring this shell company report…………………………………..
For the transition period from** **** to**** **** **
Commission file number:001-11960
ASTRAZENECA PLC
(Exact name of Registrant as specified in its charter)
England and Wales
(Jurisdiction of incorporation or organization)
1 Francis Crick AvenueCambridge Biomedical CampusCambridge CB2 0AAEngland
(Address of principal executive offices)
Adrian KempAstraZeneca PLC1 Francis Crick AvenueCambridge Biomedical CampusCambridge CB2 0AAEnglandTelephone: +44 20 3749 5000Facsimile 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 | ||
|---|---|---|---|---|
| American Depositary Shares, each representing one half of an Ordinary Share of 25¢ each | AZN | The Nasdaq Stock Market LLC | ||
| Ordinary Shares of 25¢ each | The Nasdaq Stock Market LLC * | |||
| 0.700% Notes due 2024 | | AZN 24 | | The Nasdaq Stock Market LLC |
| 3.375% Notes due 2025 | AZN 25 | The Nasdaq Stock Market LLC | ||
| 0.700% Notes due 2026 | | AZN 26 | | The Nasdaq Stock Market LLC |
| 1.200% Notes due 2026 | | AZN 26A | | The Nasdaq Stock Market LLC |
| 3.125% Notes due 2027 | AZN 27A | The Nasdaq Stock Market LLC | ||
| 1.750% Notes due 2028 | | AZN 28 | | The Nasdaq Stock Market LLC |
| 4.875% Notes due 2028 | | AZN 28A | | The Nasdaq Stock Market LLC |
| 4.000% Notes due 2029 | AZN 29 | The Nasdaq Stock Market LLC | ||
| 1.375% Notes due 2030 | | AZN 30 | | The Nasdaq Stock Market LLC |
| 4.900% Notes due 2030 | | AZN 30A | | The Nasdaq Stock Market LLC |
| 2.250% Notes due 2031 | | AZN 31 | | The Nasdaq Stock Market LLC |
| 4.875% Notes due 2033 | | AZN 33 | | The Nasdaq Stock Market LLC |
| 6.450% Notes due 2037 | AZN 37 | The Nasdaq Stock Market LLC | ||
| 4.000% Notes due 2042 | AZN 42 | The Nasdaq Stock Market LLC | ||
| 4.375% Notes due 2045 | AZN 45 | The Nasdaq Stock Market LLC | ||
| 4.375% Notes due 2048 | AZN 48 | The Nasdaq Stock Market LLC | ||
| 2.125% Notes due 2050 | | AZN 50 | | The Nasdaq Stock Market LLC |
| 3.000% Notes due 2051 | | AZN 51 | | 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, 2023 was:
| Title of Class | Number of Shares Outstanding |
|---|---|
| Ordinary Shares of 25¢ each: | 1,550,162,626 |
| Redeemable Preference Shares of £1 each: | 50,000 |
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 ☐ No ☒
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 and posted 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, a non-accelerated filer, or an emerging growth company. See definition of“accelerated filer,” “large accelerated filer,” and“emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):
| Large Accelerated Filer ☒ | Accelerated Filer ☐ | Non-accelerated Filer ☐ |
|---|---|---|
| Emerging growth company ☐ | ||
If an emerging growth company that prepares its financial statements in accordance with US 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. ☒
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to§240.10D-1(b). ☐
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
| US GAAP | ☐ | International Financial Reporting Standards as issued by the International Accounting Standards Board | ☒ | 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 2023 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 2023” included as exhibit 15.1 to this Form 20-F dated and submitted on February 20, 2024.
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 2023” 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 60, and the tables on pages 61 to 63, “Additional Information —Trade Marks” on page 231, “—Glossary” on pages 232 to 235 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 236, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 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 20, 2024. 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. For the avoidance of doubt, the “Independent auditors’ report to the members of AstraZeneca PLC” on pages 141 to 147 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 does not form part of, and is not incorporated into, this Form 20-F dated February 20, 2024.
PART 1
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE
ITEM 3. KEY INFORMATION
A. Reserved
B. Capitalization and Indebtedness
C. Reason for the Offer and Use of Proceeds
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 have been categorised consistently with the “Risk Overview—Principal Risks” detailed on pages 56 and 57 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024, each of which are included below (in addition to other risks that we face). We believe that the forward-looking statements about AstraZeneca in this Form 20-F dated February 20, 2024, identified by words such as ‘anticipates’, ‘believes’, ‘expects’ and ‘intends’, are based on reasonable assumptions. However, forward-looking statements involve inherent risks and uncertainties such as those summarised below. They relate to events that may occur in the future, that may be influenced by factors beyond our control and that may have actual outcomes materially different from our expectations. Therefore, other risks, unknown or not currently considered material, could have a material adverse effect on our financial condition or results of operations.
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| Product pipeline risks | Impact | |
| Failure or delay in the delivery of our pipeline or launch of new medicines | ||
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| 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. Details of projects that have suffered setbacks or failures during 2023 can be found in the “Strategic Report—Therapy Area Review” on pages 16 to 31 of AstraZeneca’s “Annual Report and Form 20 F Information 2023” included as exhibit 15.1 to this Form 20 F dated February 20, 2024.Launch activities may be delayed by a number of factors, including: adverse findings in preclinical 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. | | 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.Delays to launches can lead to excess expenses in the manufacture of pre-launch inventories, 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, intellectual property (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. |
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| Failure to meet regulatory or ethical requirements for medicine development or approval | ||
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| We are subject to laws and regulations that control our ability to market our pharmaceutical products. Our development programmes must meet many standards to prove our products are safe, effective and of high quality. Health authorities, such as the FDA in the US and the European Medicines Agency in the EU, can refuse to approve our products or require us to conduct additional clinical trials or scientific testing before they will approve them for marketing. Many factors influence health authority decisions to approve or reject a marketing application for a pharmaceutical product. These include advances in science and technology; new laws, regulations and policies; and different standards for evaluating safety and effectiveness. | | Delays in regulatory approvals could delay our ability to market our products and may adversely affect our revenue. Also, post-approval requirements, including additional clinical trials, could cause increased costs. We seek to manage these risks, but policymaking by governments and health authorities can be unpredictable and unforeseen circumstances, such as public health emergencies, may strain health authority resources and delay the approval of our products.Following approval, a health authority may require us to conduct additional clinical trials or scientific testing to address concerns raised after patients have used our products in the marketplace. New data may impact a product’s approval status or lead to labelling changes that limit the use of a product. |
| Commercialisation risks | Impact | |
|---|---|---|
| Failures or delays in the quality or execution of the Group’s commercial strategies | ||
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| Maximising the commercial potential of our new products underpins the success of our strategy and the delivery of our short- and medium-term targets. We may ultimately be unable to achieve commercial success for various reasons, including:> difficulties in manufacturing sufficient quantities of the product> any price control measures imposed by governments and healthcare authorities> patient access to healthcare> diagnosis rates> erosion of IP rights> failure to show a differentiated product profile> 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)> inadvertent breaches of local and international law. | | Failure to execute our commercial strategies or achieve the level of sales anticipated for a medicine 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. |
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| Pricing affordability, access and competitive pressures | ||
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| Appropriate pricing, reimbursement and policy frameworks enable us to contribute significantly to patients, public health and health practice transformation. The global economic, political and social pressures are creating an ever more challenging environment in which we operate. As a result of global financial pressures there is increased evidence of cost containment measures including:> drug pricing system reforms such as the Inflation Reduction Act (IRA) in the US> changes to reference pricing rules impacting prices in some markets> expedited approval of generic drugs and introduction of new laws, regulations and policies. | | 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. Across the industry, a new government-run drug price-setting programme in the US could reduce the value of certain products sooner than planned and impact the R&D pipeline as companies seek to avoid investing in lower yield products. |
| Supply chain and business execution risks | Impact | |
|---|---|---|
| Failure to maintain supply of compliant, quality medicines | ||
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| We may experience challenges, delays or interruptions in the manufacturing and supply of our products for various reasons, including:> Supply shortages or delays in construction of facilities to support future demand of our products caused by significant unforecasted demand growth or supply chain disruptions (e.g. natural disasters, climate impacts, COVID 19,conflict or political unrest).> The inability to supply products due to a product quality failure or regulatory compliance action such as licence withdrawal, product recall or change of regulatory standards (e.g. nitrosamines, where regulators have been introducing new limits/expectations for regulatory filings).It is necessary for us to meet all regulations, including compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) and comparable regulatory dossier conditions of approval in all countries in which our products are licensed, manufactured or sold.We rely significantly on third parties for the timely supply of goods (e.g. active ingredients and packaging components), many of which are difficult to substitute in a timely manner or at all. | | Supply chain difficulties may result in product shortages, which could lead to lost Product Sales and materially affect our reputation and results of operations.Failure to comply with all manufacturing regulations can result in negative regulatory inspection findings that could lead to the halt of manufacturing, and/or product seizure, debarment or recalls which could have an adverse effect on our business, financial condition and results of operations.In the event of insolvency of third-party suppliers, it would be difficult to substitute in a timely manner or at all. |
| adr | | |
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| Illegal trade in the Group’s medicines | ||
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| The illegal trade of 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 medicines. | | The incidence of 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 consequential risks to their health.If we are found liable for breaches in our supply chains, authorities may take action, financial or otherwise, that could restrict the distribution of our products. |
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| Reliance on third-party goods and services | ||
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| A significant proportion of AstraZeneca’s annual costs relates to spend with third-party suppliers. The level of spend supports the length of our value chain from discovery to manufacture and commercialisation of our medicines.Many of our business-critical operations are outsourced to third-party providers. We are, therefore, heavily reliant on these third parties to get medicines to patients, comply with applicable laws and regulations, while also ensuring prudent use of AstraZeneca financial resources. | Failure to successfully secure, onboard and manage outsourced services, particularly with inflationary pressures increasing, or the failure of outsourced providers to deliver timely services, and to the required level of quality, could materially adversely affect our reputation, our financial condition and operating results as well as our ability to deliver medicines to patients.Failure to effectively manage third-party suppliers when external factors, including geopolitical tensions, or raw materials and components shortages, place increased pressure on AstraZeneca’s ability to purchase goods and services may lead to major business disruption.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. | |
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| Failure in information technology or cybersecurity | ||
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| IT systems enable critical business functions. Critical business processes and functions are increasingly dependent on partner and vendor IT stability and data integrity. IT systems provide our workforce with continuous access to collaboration environments, global communications channels, applications and data. High availability IT systems remain a business imperative. In addition to availability and reliability, IT systems must comply with provisions specified in data security, privacy and individual protection laws.Data is a commodity that we prioritise continued access to and protection of. Data is often characterised as strictly confidential information. Examples of strictly confidential data include clinical trial records, personal information, IP, R&D data, and compliance information. AstraZeneca’s IT systems and data are potentially vulnerable to service interruptions and security breaches via attacks by malicious third parties or intentional or inadvertent actions by our employees or vendors. Attempts to exploit AstraZeneca are increasingly sophisticated. Threat actors include organised criminal groups, ‘hacktivists’, nation states, employees and others.The internet is our primary critical business transaction channel. Internet availability is increasingly at risk due to geopolitical tensions and conflict.Privacy legislation includes obligations to report data protection breaches to regulators and affected individuals within expedited timeframes. | | Disruption to these IT systems and/or the internet (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 hardware or software failures or breaches which could result in disclosure of confidential information, damage to our reputation, regulatory penalties or sanctions, or 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.Data loss could lead to public disclosure of confidential information which may damage our reputation, materially affect our business or results of operations, and expose us to legal risks and/or additional legal obligations. Public disclosure of sensitive information could materially adversely affect our reputation and business or operations results.Cybersecurity insurance coverage limits may not protect against any future claim or claim proceeds may be delayed.Failure to comply with regulatory disclosure requirements could cause reputational damage and a loss of public trust. |
| Failure of critical processes | ||
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| Unexpected events and/or events beyond our control could result in the failure of critical processes within the Group 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.> Cyber threats similar to those detailed in the ‘Failure in information technology or cybersecurity’ section above. | | Crystallisation of such material threats may heighten certain other risks, such as those relating to the delivery of the pipeline, launch of new medicines, or the manufacture and supply of medicines, and may lead to loss of revenue and have a materially adverse impact on our financial results. |
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| Failure to collect and manage data in line with legal and regulatory requirements and strategic objectives | ||
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| Data is increasingly recognised as being AstraZeneca’s most valuable commodity. There is an increasing range of legislative and regulatory requirements to manage data across all countries where we conduct business, these may impact certain types of data such as personal data, the way that we conduct business such as restricting the movement of data between countries or jurisdictional regions or how we make use of new technological capabilities such as artificial intelligence (AI). In addition, geopolitical changes may require changes to how AstraZeneca manages data.Beyond legal and regulatory requirements, achieving strategic objectives will require good management of data across the enterprise. As our organisation increasingly relies on data, including sensitive data relating to health and genomics, a failure to properly understand personal and collective accountabilities for managing data to maximise its value, or failure to address data risks will reduce our ability to execute at pace and deliver strategic objectives.AI technologies present significant opportunities and risks to our business. Harnessing AI’s transformative potential may enable AstraZeneca to speed up the discovery and development of new drugs, optimise our manufacturing processes, drive efficiencies and productivity, and accelerate our growth. Failure to exploit these opportunities may put AstraZeneca at a competitive disadvantage.AstraZeneca is investing significant resources into AI experimentation, development, and deployment across many parts of our business. As we scale our use of AI, it is possible not all investments will succeed.AI technologies may exacerbate existing risks, like those risks associated with data privacy, cybersecurity and IP. AI also introduces new risks due to the autonomous nature of the technology, the ease at which AI-enabled decision making can be scaled up, and the commercial pressures to adopt AI. AI systems can amplify biased and discriminatory decision making, perform unreliably and malfunction, generate insights which are difficult to interpret and explain, and cause direct harm to individuals or groups. These risks may become more significant as we increasingly utilise AI to inform, augment and automate decision making and processes in sensitive areas (e.g. clinical trials, medical decision making).The adoption and exploitation of AI is occurring under the backdrop of intense global media scrutiny, heightened political attention and low levels of public trust and understanding. There is also a range of new AI regulations being adopted and implemented worldwide, including in the EU, China and the US. | Despite taking measures designed to ensure compliance with applicable privacy- and AI-related laws and regulations by our personnel and our third parties, non-compliance has occurred and may occur again in the future. If future instances of non-compliance are deemed significant, these may attract material regulatory sanctions or fines and corresponding reputational damage, orders to stop certain processing of personal data, or legal action on behalf of impacted individuals. Further, failure to protect personal data could lead to a competitive disadvantage, loss of trust from our stakeholders, including patients, and prevent us from delivering our strategic objectives.If the scope of data-related laws is expanded or if the interpretation or enforcement of existing laws change or new privacy laws are implemented, AstraZeneca and its third-party vendors may be required to change their business practices or data processing practices and policies. This may lead to substantial compliance-related costs or materially adversely impact our business and financial condition.Our failure to use AI technologies in a way that maintains trust, quality and control in our business activities would pose reputational, legal, regulatory and financial risks to AstraZeneca. Investments in AI may not realise the benefits that were anticipated. | |
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| Failure to attract, develop, engage and retain a diverse, talented and capable workforce | ||
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| We rely heavily on recruiting and retaining talented employees with a diverse range of skills and capabilities to meet our strategic objectives. Externally there is intense competition for well-qualified individuals, as the supply of people with certain skills or in specific geographic regions may be limited.Ensuring our employees are continually developed and engaged with strategic objectives embeds commitment across the workforce. | | The inability to attract and retain highly skilled personnel may weaken our succession plans for critical positions, impact the implementation of our strategic objectives and ultimately result in the failure of our business operations.Failure to develop and engage our workforce could result in business disruption, a loss of productivity and higher turnover rates, all of which could materially adversely affect our business.Focus in 2024 will be to look at our global footprint to ensure we are best positioned to support science and the business towards the 2030 Bold Ambition. |
| Legal, regulatory and compliance risks | Impact | |
|---|---|---|
| Failure to meet regulatory or ethical expectations on environmental impact, including climate change | ||
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| Environmental issues will become more material as healthcare systems embrace net-zero climate targets.Our environmental targets and performance will have increased scrutiny by investors, governments and non-governmental organisations.Environmental considerations are becoming embedded in the public procurement of goods and services, including medicinal products and devices.Specific materials used to manufacture medicines, or used as excipients or propellants, are coming under increased regulation and 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. | | Investors are increasingly focusing on environmental issues. We continue to see an increased requirement to quantify the impact of specific environmental issues and to disclose our strategy, targets and performance.Failure to maximise our environmental sustainability credentials 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 and lead to reputational damage.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. |
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| Safety and efficacy of marketed medicines is questioned | ||
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| 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 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, contingent liabilities and contingent assets” on pages 204 to 210 of AstraZeneca’s “Annual Report and Form 20 F Information 2023” included as exhibit 15.1 to this Form 20 F dated February 20, 2024. | | 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. |
| Adverse outcome of litigation and/or governmental investigations | ||
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| Our business is subject to a wide range of laws and regulations around the world. We have been, and may continue to be, subject to various legal proceedings and governmental investigations.Actual or perceived failure to comply with laws or regulations may result in AstraZeneca and/or its employees being investigated by government agencies and authorities and/ or in civil legal proceedings. Relevant authorities have wide-ranging administrative powers to deal with any failure to comply with laws, regulations or 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 manufacturer interaction 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. Details of material litigations and governmental investigations can be found in “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments, contingent liabilities and contingent assets” on pages 204 to 210 of AstraZeneca’s “Annual Report and Form 20 F Information 2023” included as exhibit 15.1 to this Form 20 F dated February 20, 2024. | 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 civil or criminal sanctions and/or the payment of 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 the outcome, could be costly, divert management attention, or damage our reputation and demand for our products.Unfavourable resolutions to current and similar future proceedings against us that 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. | |
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| IP risks related to our products | ||
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| 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 we may 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, contingent liabilities and contingent assets” on pages 204 to 210 of AstraZeneca’s “Annual Report and Form 20 F Information 2023” included as exhibit 15.1 to this Form 20 F dated February 20, 2024. | | If we are unable to obtain, defend and enforce our IP, we may experience accelerated and intensified competition. 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. |
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| Economic and financial risks | Impact | |
|---|---|---|
| Failure to achieve strategic plans or meet targets or expectations | ||
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| When we communicate our business strategy, targets or performance expectations, all such statements are forward-looking and based on assumptions and judgements, all of which are subject to significant inherent risks and uncertainties. | | To achieve our strategic objectives, we must continue to develop commercially viable new products and successfully integrate new organisations we have acquired. There can be no guarantee that our strategy or expectations will materialise. Any failure to successfully implement our business strategy may frustrate the achievement of our financial targets, which may therefore materially damage our brand, business, financial position or results of operations. |
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| Geopolitical and/or macroeconomic volatility disrupts the operation of our global business | ||
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| 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 financial markets and/or exacerbate pressure from governments and other healthcare payers on medicine prices and other cost control measures in order to limit healthcare spending.Geopolitical tensions may lead to the imposition or escalation of trade controls, tariffs, taxes or other restrictions to market access which may increase our costs or reduce revenues. | | A severe or prolonged economic downturn could result in a variety of risks to our business, including weakened demand for medicines and our ability to raise additional capital when needed or on favourable terms, if at all. A weak or declining economy could strain our suppliers, possibly resulting in supply disruption, or cause delays in payments for our services by third-party payers.Measures taken to limit healthcare spending may lead to lower than anticipated rates of growth in some markets and an adverse impact on revenues and profitability.Any escalation in barriers to the global free flow of medicines is likely to increase costs to serve affected markets which may lead to downward pressure on margins. While the introduction of severe sanctions is unlikely in relation to medicines, it could occur if matters escalate significantly and could impact processes for the commercialisation of medicines and levels of sales in affected markets.Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business. |
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| Failure in financial control or the occurrence of fraud | ||
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| Effective internal controls assist in the provision of reliable Financial Statements and the detection and prevention of fraud. Testing of internal controls provides only limited assurance over the accuracy of Financial Statements and may not prevent or detect misstatements or fraud. | | 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. Any of the foregoing could adversely affect our financial results and lead to reputational damage. |
| Unexpected deterioration in the Group’s financial position | ||
|---|---|---|
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| Movements in exchange rates against the US dollar, our reporting currency, impact our reported results. The key currencies of Product Sales and costs are: US dollar, Chinese renminbi, euro, Japanese yen, Swedish krona and pound sterling.Most of our cash is invested in AAA credit-rated institutional money market funds, fixed income securities issued by government, financial and non-financial entities and collateralised and non-collateralised bank deposits. Our credit exposure is a mix of US, EU and rest of world default risk across these institutions.We invest in many projects in an effort to develop a successful portfolio of approved products. Our Consolidated Statement of Financial Position therefore contains significant investments in intangible assets, including goodwill. Our ability to realise value on these investments depends on regulatory approvals, market acceptance, competition, and legal developments.Our defined benefit post-retirement obligations (primarily in the UK and Sweden) can materially change in value but are largely backed by assets invested in growth and liability hedging portfolios, which hedge some of the risks inherent in liability valuations.Although we maintain relevant insurance coverage for risks arising within the Group, we may not be able to maintain our insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses.Tax law is complex, leading to the risk of different interpretations. Revenue authorities can make conflicting claims to the profits taxed in individual countries leading to double taxation and the potential for fines and penalties. Tax laws can change following action by international bodies such as the Organisation for Economic Co-operation and Development (OECD) or individual governments. | Foreign exchange rate movements may materially adversely affect our financial condition or results of operations.In a sustained economic downturn, such institutions may cease to trade and there can be no guarantee that we will be able to access the full value of our investments.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.Solvency levels could fall, leading to higher contributions if there are: falls in assets; increases in liability valuations (from falls in bond yields, increases in inflation or lower mortality); or changes in regulations. As liability valuation risks are hedged to a material level, significant collateral may need to be posted, which in extreme circumstances could lead to a short-term liquidity risk in some pension schemes and a request to the Group to provide temporary liquidity.Uninsured losses, or those where an insurer denies coverage, could materially adversely affect our financial condition.The resolution of tax disputes can result in incremental tax costs, a reallocation of profits or losses between jurisdictions, or even double taxation, fines and penalties. They are costly, divert management attention and may adversely affect our reputation.If tax treaties are withdrawn or amended, or Competent Authorities are unable to reach an agreement that eliminates double taxation, this could materially adversely affect our financial position. For details of our financial risk management policies, see “Strategic Report—Financial Review—Financial risk management” on page 71 and for details of current tax disputes, see “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments, contingent liabilities and contingent assets” on pages 204 to 210 of AstraZeneca’s “Annual Report and Form 20 F Information 2023” included as exhibit 15.1 to this Form 20 F dated February 20, 2024.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. | |
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.
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 pages 65 to 66, “Strategic Report—Financial Review—Restructuring” on page 67, “Strategic Report—Financial Review—Acquisitions treated as Business combinations” and “—Acquisitions treated as asset acquisitions” on page 69, “Strategic Report—Financial Review—Investments, divestments and capital expenditure” on page 70, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Board Leadership and Company Purpose” on page 81 and “Additional Information—Important information for readers of this Annual Report—AstraZeneca websites” on page 236, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference. Additionally, the information set forth under the heading “Strategic Report—Financial Review” on pages 60 to 76 of AstraZeneca’s “Annual Report and Form 20-F Information 2022” included as exhibit 15.1 to the Form 20-F dated February 21, 2023 is incorporated herein 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 page 5, “Strategic Report—Chair’s Statement” on page 2, “Strategic Report—Chief Executive Officer’s Review” on pages 3 to 4, “Strategic Report—Science can…” on page 6, “Strategic Report—Healthcare in a Changing World” on pages 7 to 9, “Strategic Report—Our Purpose, Values and Business Model” on pages 10 to 11, “Strategic Report—Our strategy and Key Performance Indicators” on pages 12 to 15, “Strategic Report—Therapy Area Review” on pages 16 to 31, “Strategic Report—Business Review” on pages 32 to 49, “Strategic Report—Task Force on Climate-related Financial Disclosures Summary Statement” on pages 51 to 53, “Strategic Report—Risk Overview—Managing risk”, “—Risk Overview—Emerging risks”, “—Risk Overview—Climate risk”, “—Risk Overview—Cybersecurity Risk” on page 54, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Global Compliance and Group Internal Audit (GIA)” on page 83, “Corporate Governance—Corporate Governance Report—Principal Decisions—Acquisitions and collaborations to strengthen pipeline” on page 87, “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” on pages 160 to 161, “Financial Statements—Notes to the Group Financial Statements—Note 6—Segment information” on page 167 to 169, “Additional Information—Sustainability: supplementary information” on page 230, and “Additional Information—Important information for readers of this Annual Report—Statements of competitive position, growth rates and sales” on page 236, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
Development Pipeline as of February 8, 2024
This section sets out AstraZeneca-sponsored or -directed trial New Molecular Entities (NMEs) and significant indications.
First major market regulatory submission date and submission status is provided for assets in Phase III or 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
Phase I
| Compound | Mechanism | AdditionalInformation | Area Under Investigation | ||||
|---|---|---|---|---|---|---|---|
| Oncology | | | | | |||
| AZD0305 | | GPRC5D ADC | | | | relapsed/refractory multiple myeloma | |
| AZD0486 | | CD19-CD3 TCE | | | | R/R B-cell non-Hodgkin lymphoma | |
| AZD0486 | | CD19-CD3 TCE | | | | B-cell acute lymphoblastic leukaemia | |
| AZD1390 | | ATM inhibitor | | | | glioblastoma | |
| AZD3470 | | PRMT5 inhibitor | | | | classic Hodgkin lymphoma, solid tumours | |
| AZD5335 | | anti-folate receptor alpha topoisomerase 1 inhibitor ADC | | | | ovarian cancer, lung adenocarcinoma | |
| AZD5851 | | GPC3 CAR-T | | | | hepatocellular carcinoma | |
| AZD5863 | | CLDN18.2 x CD3 bi-specific antibody (HBM7022) | | | | solid tumours | |
| AZD6422 | | CLDN18.2 CAR-T | | | | solid tumours | |
| AZD8421 | | CDK2 inhibitor | | | | solid tumours | |
| AZD9592 | | EGFR/cMET | | | | solid tumours | |
| AZD9829 | | CD123 TOP1i ADC | | | | acute myeloid leukemia, myelodysplastic syndromes | |
| NT-125 | | autologous, fully-individualised, multi-specific TCR-T targeting neoantigens | | | | solid tumours | |
| NT-175 | | TGFBR2 KO armoured TCR-T targeting TP53 R175H/HLA-A*02:01 | | | | solid tumours | |
| volrustomig + lenvatinib | | PD-1/CTLA-4 bispecific mAb + VEGF | | | | advanced renal cell carcinoma | |
| CVRM | | | | | | ||
| AZD2373 | | podocyte health | | | | nephropathy | |
| AZD2389 | | anti-fibrotic mechanism | | | | metabolic dysfunction-associated steatohepatitis | |
| AZD4144 | | inflammation modulator | | | | cardiorenal disease | |
| AZD5462 | | RXFP1 agonist | | (PP) | | heart failure | |
| AZD6234 | | peptide | | | | obesity with related comorbidities | |
| AZD7503 | | ASO | | | | non-alcoholic steatohepatitis | |
| AZD9550 | | GLP-1R glucagon dual agonist | | | | non-alcoholic steatohepatitis | |
| Respiratory & Immunology | | | | | | ||
| AZD1163 | | bispecific antibody | | | | rheumatoid arthritis | |
| AZD5055 | | porcupine inhibitor | | | | idiopathic pulmonary fibrosis | |
| AZD6793 | | IRAK4 inhibitor | | | | inflammatory diseases | |
| AZD6912 | | siRNA | | | | rheumatoid arthritis | |
| AZD7798 | | humanised monoclonal antibody targets T cells subset | | | | Crohn’s disease | |
| AZD8630 | | inhaled TSLP FAb | | (PP) | | asthma | |
| Other Medicines | | | | | |||
| AZD4041 | | orexin 1 receptor antagonist | | (PP) | | opioid use disorder | |
| MEDI0618 | | PAR2 antagonist mAb | | Phase I/IIa | | migraine | |
| MEDI1814 | | amyloid beta mAb | | (PP) | | Alzheimer’s disease | |
| Rare Disease | | | | | |||
| ALXN1910 | | next generation TNSALP ERT | | | | bone metabolism | |
| ALXN1920 | | kidney-targeted factor H fusion protein | | | | nephrology | |
| ALXN2030 | | siRNA targeting complement C3 | | | | nephrology | |
| ALXN2080 | | oral factor D inhibitor | | | | healthy volunteers | |
| Vaccine and Immune therapies | | | | | | ||
| COVID mRNA VLP vaccine | | Vaccine | | | | COVID-19 | |
Phase II
| Compound | Mechanism | AdditionalInformation | Area Under Investigation | ||||
|---|---|---|---|---|---|---|---|
| Oncology | | | | | |||
| AZD0171 + Imfinzi + CTx | | anti-LIF mAb + PD-L1 mAb + CTx | | | | 1st-line metastatic pancreatic ductal adenocarcinoma | |
| AZD0901 | | CLDN18.2 MMAE ADC | | | | solid tumours | |
| AZD8205 | | B7-H4 targeting ADC | | | | solid tumours | |
| AZD9574 | | PARP inhibitor | | | | advanced solid malignancies | |
| camizestrant | | selective estrogen receptor degrader | | | | estrogen receptor +ve breast cancer | |
| ceralasertib | | ATR inhibitor | | | | solid tumours | |
| IPH5201 + Imfinzi | | CD39 + PD-L1 | | (PP) | | neoadjuvant/adjuvant NSCLC | |
| rilvegostomig ARTEMIDE-01 | | PD-1/TIGIT bispecific mAb | | (PP) | | solid tumours | |
| sabestomig | | PD-1/TIM3 bispecific mAb | | solid tumours (Phase II), haematological malignancies (Phase I) | | solid tumours, haematological malignancies | |
| saruparib | | PARP1Sel | | | | solid tumours | |
| volrustomig | | PD-1/CTLA-4 bispecific mAb | | | | solid tumours | |
| CVRM | | | | | | ||
| AZD0780 | | PCSK9 | | | | dyslipidaemia | |
| AZD2693 | | NASH resolution | | | | non-alcoholic steatohepatitis | |
| AZD3427 | | relaxin mimetic | | | | heart failure | |
| balcinrenone/dapagliflozin | | MR modulator + SGLT2 inhibitor | | | | heart failure with CKD | |
| MEDI6570 | | LOX-1 mAb | | | | cardiovascular disease | |
| mitiperstat | | myeloperoxidase | | | | heart failure with a preserved ejection fraction/NASH | |
| zibotentan/dapagliflozin | | endothelin A receptor antagonist/SGLT2 inhibitor | | | | liver cirrhosis | |
| Respiratory & Immunology | | | | | | ||
| atuliflapon | | FLAP inhibitor | | | | asthma | |
| AZD4604 | | inhaled JAK1 inhibitor | | | | asthma | |
| mitiperstat | | myeloperoxidase | | | | COPD | |
| tozorakimab FRONTIER 3 | | IL-33 mAb | | | | asthma | |
| Other Medicines | | | | | |||
| MEDI1341 | | alpha synuclein mAb | | (PP) | | multiple system atrophy/Parkinson’s disease | |
| MEDI7352 | | NGF/TNF bispecific mAb | | | | osteoarthritis pain and painful diabetic neuropathy | |
| Rare Disease | | | | | | ||
| vemircopan | | oral factor D inhibitor | | | | generalised myasthenia gravis | |
| vemircopan | | oral factor D inhibitor | | | | proliferative lupus nephritis or immunoglobulin A nephropathy | |
| Voydeya (danicopan) | | oral factor D inhibitor | | | | geographic atrophy | |
Phase III/Pivotal Phase II/Registration (listed until launch in all applicable major markets)
| Compound | Mechanism | Area UnderInvestigation | AdditionalInformation | Estimatedsubmission/submissionstatus | |||||
|---|---|---|---|---|---|---|---|---|---|
| Oncology | | | | | | ||||
| camizestrant + CDK4/6i SERENA-6 | | selective estrogen receptor degrader + CDK4/6 inhibitors | | 1st-line HR+ HER2- ESR1m breast cancer | | | | 2025 | |
| camizestrant +palbociclib SERENA-4 | | selective estrogen receptor degrader + CDK4/6 inhibitor | | 1st-line HR+ HER2- breast cancer | | | | 2025 | |
| camizestrant CAMBRIA-1 | | selective estrogen receptor degrader | | HR+ HER2- extended adjuvant breast cancer | | | | >2025 | |
| camizestrant CAMBRIA-2 | | selective estrogen receptor degrader | | ER+/HER2- early breast cancer | | | | >2025 | |
| ceralasertib +Imfinzi LATIFY | | ATR inhibitor + PDL-1 mAb | | NSCLC | | | | >2025 | |
| datopotamab deruxtecan AVANZAR | | TROP2 ADC | | 1L NSCLC, squamous and non-squamous 1L NSCLC, TROP2 BM+ | | (PP) | | 2025 | |
| datopotamab deruxtecan TROPION-Breast01 | | TROP2 ADC | | 2-3L HR+ HER2- breast cancer | | (PP) | | H1 2024 | |
| datopotamab deruxtecan TROPION-Breast02 | | TROP2 ADC | | 1st-line triple negative breast cancer | | (PP) | | 2025 | |
| datopotamab deruxtecan TROPION-Breast03 | | TROP2 ADC | | adjuvant residual disease triple negative breast cancer | | (PP) | | >2025 | |
| datopotamab deruxtecan TROPION-Breast04 | | TROP2 ADC | | neoadjuvant/adjuvant triple negative or HR-low/HER2-negative breast cancer | | (PP) | | >2025 | |
| datopotamab deruxtecan TROPION-Breast05 | | TROP2 ADC | | 1L PD-L1+ triple negative breast cancer | | (PP) | | >2025 | |
| datopotamab deruxtecan TROPION-Lung01 | | TROP2 ADC | | 2L+ NSCLC with or without actionable genomic alterations | | (PP) | | H1 2024 | |
| datopotamab deruxtecan TROPION-Lung07 | | TROP 2 ADC | | 1L NSCLC PD-L1 <50% non-squamous | | (PP) | | >2025 | |
| datopotamab deruxtecan TROPION-Lung08 | | TROP2 ADC | | 1L metastatic NSCLC without actionable genomic alterations and PD-L1 TPS ≥50% | (PP) | | 2025 | | |
| Imfinzi + Imjudo HIMALAYA | | PD-L1 mAb + CTLA-4 mAb | | 1st-line hepatocellular carcinoma | | (PP) | | Launched | |
| Imfinzi +/- oleclumab +/- monalizumab PACIFIC-9 | | PD-L1 + NKG2A or PD-L1 + CD73 | | unresectable Stage III NSCLC | | (PP) | | >2025 | |
| rilvegostomig ARTEMIDEBiliary01 | | PD-1/TIGIT bispecific mAb | | adjuvant biliary tract cancer | | (PP) | | >2025 | |
| saruparib EvoPAR-Prostate01 | | PARP1Sel | | metastatic castration-sensitive prostate cancer | | | | >2025 | |
| Truqap (capivasertib) + Faslodex CAPItello-291 | | AKT inhibitor + fulvestrant | | 2nd-line and beyond in aromatase inhibitor resistant locally advanced (inoperable) or metastatic breast cancer | | (PP) | | Launched | |
| volrustomig eVOLVE-Cervical | | PD-1/CTLA-4 bispecific mAb | | locally advanced cervical cancer | | | | >2025 | |
| volrustomig eVOLVE-HNSCC | | PD-1/CTLA-4 bispecific mAb | | unresected locally advanced head and neck squamous cell carcinoma | | | | >2025 | |
| volrustomig eVOLVE-Lung02 | | PD-1/CTLA-4 bispecific mAb | | 1L metastatic NSCLC | | | | >2025 | |
| volrustomig eVOLVE-Meso | | PD-1/CTLA-4 bispecific mAb | | 1L unresectable malignant pleural mesothelioma | | | | >2025 | |
| CVRM | | | | | | | |||
| Andexxa | | anti-factor Xa reversal | | acute major bleed | | | | Launched | |
| baxdrostat | | aldosterone synthase inhibitor | | hypertension | | | | >2025 | |
| roxadustat OLYMPUS ROCKIES | | hypoxia-inducible factor prolyl hydroxylase inhibitor | | anaemia in chronic kidney disease/end-stage renal disease | | (PP) | | Launched | |
| Wainua (eplontersen) | | ligand-conjugated antisense | | patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) | | (PP) | | Launched | |
| zibotentan/dapagliflozin | | endothelin A receptor antagonist/SGLT2 inhibitor | | CKD with high proteinuria | | | | >2025 | |
| Respiratory & Immunology | | | | | | ||||
| Fasenra CALIMA SIROCCO ZONDA MIRACLE | | IL-5R mAb | | severe uncontrolled asthma | | (PP) | | Launched | |
| Saphnelo TULIP 1 & TULIP 2 AZALEA (China) | | type I IFN receptor mAb | | systemic lupus erythematosus | | (PP) | | Launched | |
| Tezspire NAVIGATOR DIRECTION (China) | | TSLP mAb | | severe uncontrolled asthma | | (PP) | | Launched | |
| tozorakimab OBERON TITANIA PROSPERO MIRANDA | | IL-33 mAb | | chronic obstructive pulmonary disease | | | | >2025 | |
| tozorakimab TILIA | | IL-33 mAb | | severe viral lower respiratory tract disease | | | | 2025 | |
| Vaccine and Immune Therapies | | | | | | ||||
| Beyfortus | | RSV mAb-YTE | | passive RSV immunisation | | (PP) | | Launched | |
| sipavibart (AZD3152) SUPERNOVA | | SARS-CoV-2 LAAB | | prevention of COVID-19 | | | | H1 2024 | |
| Rare Disease | | | | | | ||||
| acoramidis | | oral TTR stabiliser | | transthyretin amyloid cardiomyopathy | | (PP) | | H1 2024 | |
| ALXN2220 | | transthyretin depleter | | transthyretin amyloid cardiomyopathy | | (PP) | | >2025 | |
| anselamimab | | fibril-reactive mAb | | amyloid light chain amyloidosis | | | | 2025 | |
| efzimfotase alfa (ALXN1850) | | next generation TNSALP ERT | | hypophosphatasia | | | | >2025 | |
| gefurulimab | | humanised bispecific VHH antibody | | generalised myasthenia gravis | | | | >2025 | |
| Voydeya (danicopan) ALPHA | | oral factor D inhibitor | | paroxysmal nocturnal haemoglobinuria with clinically significant extravascular haemolysis | | | | Approved | |
Significant Life-cycle Management
First major market regulatory submission date and submission status is provided for assets in Phase III or beyond. Projects in Phase III unless otherwise noted.
| Compound | Mechanism | Area Under Investigation | AdditionalInformation | Estimatedsubmission/submission status | |||||
|---|---|---|---|---|---|---|---|---|---|
| | | | | | | | | | |
| Oncology | | | | | | | | | |
| Calquence + R-CHOP ESCALADE | | BTK inhibitor + R-CHOP | | 1st-line diffuse large B cell lymphoma | | | | >2025 | |
| Calquence + venetoclax + obinutuzumab AMPLIFY | | BTK inhibitor + BCL-2 inhibitor + anti-CD20 mAb | | 1st-line chronic lymphocytic leukaemia | | (PP) | | >2025 | |
| Calquence ECHO | | BTK inhibitor | | 1st-line mantle cell lymphoma | | (PP) | | >2025 | |
| Calquence ELEVATE-TN ChangE (China) | | BTK inhibitor | | 1st-line chronic lymphocytic leukaemia | | (PP) | | Launched | |
| Enhertu (platform) DESTINY-Breast07 | | HER2 targeting antibody drug conjugate | | HER2+ breast cancer | | (PP) Phase II LCM | | | |
| Enhertu (platform) DESTINY-Breast08 | | HER2 targeting ADC | | HER2-low breast cancer | | (PP) Phase I LCM | | | |
| Enhertu DESTINY-Breast02 | | HER2 targeting ADC | | HER2+, unresectable and/or metastatic breast cancer pretreated with prior standard of care HER2 therapies, including T-DM1 | | (PP) | | Approved | |
| Enhertu DESTINY-Breast05 | | HER2 targeting ADC | | HER2+ post-neoadjuvant high-risk breast cancer | | (PP) | | >2025 | |
| Enhertu DESTINY-Breast06 | | HER2 targeting ADC | | post-ET HER2-low/HR+ breast cancer 2L | | (PP) | | H2 2024 | |
| Enhertu DESTINY-Breast09 | | HER2 targeting ADC | | 1st-line HER2+ breast cancer | | (PP) | | 2025 | |
| Enhertu DESTINY-Breast11 | | HER2 targeting ADC | | neoadjuvant HER2+ breast cancer | | (PP) | | 2025 | |
| Enhertu DESTINY-Gastric01 | | HER2 targeting ADC | | HER2-over-expressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens | | (PP) | | Launched | |
| Enhertu DESTINY-Gastric04 | | HER2 targeting ADC | | 2nd-line HER2+ gastric cancer | | (PP) | | >2025 | |
| Enhertu DESTINY-Lung04 | | HER2 targeting ADC | | 1st-line HER2m NSCLC | | (PP) | | >2025 | |
| Enhertu DESTINYPanTumour01 | | HER2 targeting ADC | | HER2 mutant tumours | | (PP) Phase II LCM | | | |
| Enhertu DESTINYPanTumour02 | | HER2 targeting ADC | | HER2 expressing solid tumours | | (PP) Phase II LCM | | Accepted | |
| Imfinzi (platform) BEGONIA | | PD-L1 mAb with paclitaxel and multiple novel oncology therapies | | 1st-line metastatic triple negative breast cancer | | Phase II LCM | | | |
| Imfinzi (platform) HUDSON | | PD-L1 mAb + multiple novel oncology therapies | | post IO NSCLC | | Phase II LCM | | | |
| Imfinzi + CRT KUNLUN | | PD-L1 mAb + CRT | | locally advanced oesophageal squamous cell carcinoma | | (PP) | | >2025 | |
| Imfinzi + CRT PACIFIC-5 (China) | | PD-L1 mAb + CRT | | locally-advanced (Stage III) NSCLC | | (PP) | | 2025 | |
| Imfinzi + CTx neoadjuvant AEGEAN | | PD-L1 mAb + CTx | | locally-advanced (Stage II-III) NSCLC | | | | Accepted | |
| Imfinzi + CTx NIAGARA | | PD-L1 mAb + CTx | | muscle invasive bladder cancer | | | | 2025 | |
| Imfinzi + domvanalimab (AB154) PACIFIC-8 | | PD-L1 mAb + TIGIT | | unresectable Stage III NSCLC | | (PP) | | >2025 | |
| Imfinzi + EV +/- Imjudo VOLGA | | PD-L1 + nectin-4 targeting ADC +/- CTLA-4 | | muscle invasive bladder cancer | | | | 2025 | |
| Imfinzi + FLOT MATTERHORN | | PD-L1 mAb + CTx | | neoadjuvant/adjuvant gastric cancer | | (PP) | | 2025 | |
| Imfinzi + Imjudo +SoC NILE | | PL-L1 mAb + CTLA-4 mAb + SoC | | 1st-line urothelial cancer | | | | H2 2024 | |
| Imfinzi + Imjudo + TACE +/- lenvatinib EMERALD-3 | | PD-L1 + CTLA-4 + VEGF +/- chemoembolisation | | locoregional hepatocellular carcinoma | | | | >2025 | |
| Imfinzi + VEGF + TACE EMERALD-1 | | PD-L1 mAb + VEGF + TACE | | locoregional hepatocellular carcinoma | | (PP) | | H1 2024 | |
| Imfinzi + VEGF EMERALD-2 | | PD-L1 mAb + VEGF | | adjuvant hepatocellular carcinoma | | (PP) | | 2025 | |
| mfinzi +/- Imjudo + CRT ADRIATIC | | PD-L1 mAb +/- CTLA-4 mAb + CRT | | 1st-line limited-stage small-cell lung cancer | | (PP) | | H2 2024 | |
| Imfinzi +/- Imjudo + CTx POSEIDON | | PD-L1 mAb +/- CTLA-4 mAb + CTx | | 1st-line NSCLC | | | | Launched | |
| Imfinzi (platform) NeoCOAST-2 | | PD-L1 mAb + multiple novel oncology therapies | | NSCLC | | (PP) Phase II LCM | | | |
| Imfinzi post-SBRT PACIFIC-4 | | PD-L1 mAb post-SBRT | | Stage I/II NSCLC | | PP | | >2025 | |
| Imfinzi POTOMAC | | PD-L1 mAb | | non-muscle invasive bladder cancer | | | | 2025 | |
| Lynparza (basket) LYNK002 | | PARP inhibitor | | HRRm cancer | | (PP) Phase II LCM | | | |
| Lynparza +abiraterone PROpel | | PARP inhibitor + NHA | | prostate cancer | | (PP) | | Launched | |
| Lynparza + Imfinzi + bevacizumab DUO-O | | PARP inhibitor + PD-L1 mAb + VEGF inhibitor | | 1st-line ovarian cancer | | ( PP) | | H1 2024 | |
| Lynparza + Imfinzi DUO-E | | PARP inhibitor + PD-L1 mAb | | 1st-line endometrial cancer | | (PP) | | Submitted | |
| Lynparza MONO-OLA1 | | PARP inhibitor | | 1st-line BRCAwt ovarian cancer | | (PP) | | 2025 | |
| Lynparza OlympiA | | PARP inhibitor | | gBRCA adjuvant breast cancer | | (PP) | | Launched | |
| Orpathys + Imfinzi SAMETA | | MET inhibitor + PD-L1 mAb | | 1st-line papillary renal cell carcinoma | | (PP) | | 2025 | |
| Tagrisso + CTx FLAURA2 | | EGFR inhibitor + CTx | | 1st-line advanced EGFRm NSCLC | | | | Accepted | |
| Tagrisso + Orpathys SAFFRON | | EGFR inhibitor + MET inhibitor | | advanced EGFRm NSCLC | | (PP) | | 2025 | |
| Compound | Mechanism | Area Under Investigation | AdditionalInformation | Estimatedsubmission/submission status | |||||
|---|---|---|---|---|---|---|---|---|---|
| | | | | | | | | | |
| Tagrisso + Orpathys SAVANNAH | | EGFR inhibitor + MET inhibitor | | advanced EGFRm NSCLC | | (PP) Phase II LCM | | | |
| Tagrisso +/- CTx neoadjuvant NeoADAURA | | EGFR inhibitor +/- CTx | | Stage II/III resectable EGFRm NSCLC | | | | H2 2024 | |
| Tagrisso ADAURA2 | | EGFR inhibitor | | adjuvant EGFRm NSCLC Stage Ia2-Ia3 following complete tumour resection | | | | >2025 | |
| Tagrisso LAURA | | EGFR inhibitor | | Stage III EGFRm non-small cell lung cancer | | | | H1 2024 | |
| Tagrisso ORCHARD platform study | | EGFR inhibitor + multiple novel oncology therapies | | 2nd-line EGFRm osimertinib-resistant NSCLC | | (PP) Phase II LCM | | | |
| Truqap (capivasertib) | | AKT inhibitor | | prostate cancer | | Phase II LCM | | | |
| Truqap (capivasertib) + abiraterone CAPItello-281 | | AKT inhibitor + abiraterone | | PTEN deficient metastatic hormone sensitive prostate cancer | | | | 2025 | |
| Truqap (capivasertib) + CTx CAPItello-290 | | AKT inhibitor + CTx | | 1st-line metastatic triple negative breast cancer | | | | H2 2024 | |
| Truqap (capivasertib) + docetaxel CAPItello-280 | | AKT inhibitor + docetaxel | | mCRPC prostate cancer | | | | >2025 | |
| Truqap (capivasertib) + Faslodex + Palbociclib CAPItello-292 | | AKT inhibitor + fulvestrant + CDK4/6 inhibitor | | 1st-line triplet in early relapse/ET resistant locally advanced (inoperable) or metastatic breast cancer | | PhIb/III | | >2025 | |
| CVRM | | | | | | | | | |
| Andexxa | | anti-factor Xa reversal | | urgent surgery | | | | | |
| Farxiga/Forxiga DAPA-MI | | SGLT-2 inhibitor | | prevention of heart failure and CV death following a myocardial infarction | | | | n/a | |
| Roxadustat | | hypoxia-inducible factor prolyl hydroxylase inhibitor | | chemotherapy induced anaemia | | (PP) | | Accepted | |
| Wainua (eplontersen) | | ligand-conjugated antisense | | patients with hereditary or wild-type transthyretin-mediated amyloid cardiomyopathy (ATTR CM) | | (PP) | | 2025 | |
| Respiratory & Immunology | | | | | | | | | |
| Breztri/Trixeo (PT010) KALOS LOGOS | | LABA/LAMA/ICS | | asthma | | | | 2025 | |
| Breztri/Trixeo ATHLOS | | LABA/LAMA/ICS | | COPD cardiopulmonary exercise test (CPET) trial | | | | 2025 | |
| Fasenra MANDARA | | IL-5R mAb | | eosinophilic granulomatosis with polyangiitis | | | | Submitted | |
| Fasenra NATRON | | IL-5R mAb | | hypereosinophilic syndrome | | | | H2 2024 | |
| Fasenra ORCHID | | IL-5R mAb | | nasal polyps | | (PP) | | 2025 | |
| Fasenra RESOLUTE | | IL-5R mAb | | chronic obstructive pulmonary disease | | (PP) | | >2025 | |
| Saphnelo DAISY | | type I IFN receptor mAb | | systemic sclerosis | | (PP) | | >2025 | |
| Saphnelo IRIS | | type I IFN receptor mAb | | lupus nephritis | | (PP) | | >2025 | |
| Saphnelo TULIP-SC | | type I IFN receptor mAb | | systemic lupus erythematosus (subcutaneous) | | (PP) | | 2025 | |
| Tezspire COURSE | | TSLP mAb | | chronic obstructive pulmonary disease | | (PP) Phase II LCM | | | |
| Tezspire CROSSING | | TSLP mAb | | eosinophilic esophagitis | | (PP) | | >2025 | |
| Tezspire WAYPOINT | | TSLP mAb | | nasal polyps | | (PP) | | 2025 | |
| Rare Disease | | | | | | | | | |
| Ultomiris | | anti-complement C5 mAb | | proliferative lupus nephritis or immunoglobulin A nephropathy | | Phase II LCM | | | |
| Ultomiris | | anti-complement C5 mAb | | haematopoietic stem cell transplant–associated thrombotic microangiopathy | | | | 2025 | |
| Ultomiris | | anti-complement C5 mAb | | generalised myasthenia gravis | | | | Launched | |
| Ultomiris ARTEMIS | | anti-complement C5 mAb | | cardiac surgery-associated acute kidney injury | | | | >2025 | |
| Ultomiris CHAMPIONN-MOSD | | anti-complement C5 mAb | | neuromyelitis optica spectrum disorder | | | | Launched | |
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. Details of material challenges by third parties can be found in “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments, contingent liabilities and contingent assets” on pages 204 to 210 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024, and incorporated by reference. The expiry dates shown below include granted Supplementary Protection Certificate (SPC) and Patent Term Extension (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. The expiry dates of relevant regulatory 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. There may be agreements permitting generic or biosimilar entry prior to the expiry dates shown below. Bolded expiry dates relate to new molecular entity patents, the remaining dates relate to other patents.
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| · · · · · · · · · · · · · · · · · · Aggregate Product | ||||||||||||||||||||||
| · · · · · · · · · · · · US · · Sales Ex-US | ||||||||||||||||||||||
| · · · · · · · · · · · · Product Sales ($m) · · ($m) | ||||||||||||||||||||||
| Key Marketed products · Description · US · China · EU · Japan · 2023 · 2022 · 2021 · 2023 · 2022 · 2021 | ||||||||||||||||||||||
| 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 | 2032-2035, 2036 | 2 | 2037, 2036 | 1,815 | 1,657 | 1,089 | 699 | 400 | 149 | ||||||||||
| Enhertu3 (trastuzumab deruxtecan) | A HER2-directed antibody drug conjugate indicated for HER2-positive and HER2-low advanced breast cancers, for HER2-mutant metastatic non-small cell lung cancer (NSCLC), and for HER2-positive advanced gastric cancer. | 2033, 2035 | 2033-2035 | 2033-2035 | | 4 | — | | — | — | 261 | 79 | 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. | expired | expired | expired | 2025-2026 | 31 | 17 | 30 | | 266 | 317 | 401 | ||||||||||
| Imfinzi (durvalumab) | A human monoclonal antibody (mAb) that blocks PD-1 and CD80 on T-cells indicated for unresectable, Stage III NSCLC, for extensive-stage small cell lung cancer in combination with chemotherapy, for advanced biliary tract cancer in combination with chemotherapy, for unresectable heptatocellular carcinoma (uHCC) in combination with Imjudo, for NSCLC in combination with Imjudo and chemotherapy, and for advanced bladder cancer. | 2031 | 2030 | 2030 | 2033 | 2,171 | 1,539 | 1,245 | 1,848 | 1,232 | 1,167 | |||||||||||
| Imjudo5 (tremelimumab) | | A cytotoxic T-lymphocyte-associated antigen 4 blocking antibody indicated for uHCC in combination with Imfinzi and for NSCLC in combination with Imfinzi and chemotherapy. | | 2031 | | 2026 | | 2026 | | 2026 | | 146 | | 13 | | — | | 72 | | — | | — |
| 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. | expired | | 2023 | 2023 | 2023 | 5 | 9 | 11 | 66 | 105 | 172 | ||||||||||
| Lynparza6 (olaparib) | An oral poly ADP-ribose polymerase (PARP) inhibitor indicated for platinum-sensitive relapsed and for BRCA-mutated (BRCAm) ovarian cancers, for homologous recombination repair deficient (HRD)-positive advanced ovarian cancer in combination with bevacizumab, for gBRCAm, HER2-negative early and metastatic breast cancers, for gBRCAm metastatic pancreatic cancer, for HRR gene-mutated and BRCAm metastatic castration-resistant prostate cancers (mCRPC), and for 1st-line mCRPC in combination with abiraterone. | 2022-2024, 2027*, 2024-2031 | 2024, 2024-2029 | 2029, 2024-2029 | 2029, 2024-2034 | 1,254 | 1,226 | 1,087 | 1,557 | 1,412 | 1,261 | |||||||||||
| Orpathys (savolitinib) | An oral, potent and highly selective MET TKI indicated for NSCLC with MET gene alterations. | 2030 | 2030 | 2030 | 2030 | — | — | — | 44 | 33 | 16 | |||||||||||
| Tagrisso (osimertinib) | An EGFR-TKI indicated for early- and late-stage EGFRm NSCLC. | 2032, 2035 | 2032, 2035 | 2032, 2035 | 2034, 2035 | 2,276 | 2,007 | 1,780 | 3,523 | 3,437 | 3,235 | |||||||||||
| Truqap (capivasertib) | A first-in-class, potent, adenosine triphosphate (ATP)-competitive inhibitor approved in combination with Faslodex for HR-positive, HER2-negative advanced breast cancer with certain gene alterations. | 2028-2030, 2025-2033 | 2028, 2033 | 2028, 2025-2033 | 2028 | 6 | — | — | — | — | — | |||||||||||
| Zoladex7 (goserelin acetate implant) | A luteinising hormone-releasing hormone (LHRH) agonist used to treat prostate cancer, breast cancer and certain benign gynaecological disorders. | expired | expired | expired | expired | 14 | 15 | 13 | 938 | 912 | 935 | |||||||||||
| CVRM | | | | | | | | | | | | |||||||||||
| Andexxa/ Ondexxya (andexanet alfa) | A factor Xa inhibitor reversal agent. | 2032, 2028–2037 | 2028, 2030–2035 | 2028, 2030–2037 | 2028, 2030–2037 | 75 | 77 | 50 | 107 | 73 | 18 | |||||||||||
| 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 ACS or high-risk patients with history of MI, high-risk patients with coronary artery disease or stroke. | | 2025, 2030-2036 | | expired | | 2025 | | 2023-2024, 2025-2030 | | 744 | | 744 | | 735 | | 580 | | 614 | | 737 |
| Bydureon/ Bydureon BCise (exenatide XR injectable suspension) | An injectable glucagon-like Peptide-1 receptor agonist (GLP-1RA) available as a single-dose tray, a single-dose pen or autoinjector device indicated for use in adults with type-2 diabetes (T2D). | 2024-2028, 2031 | 8 | 2024-2028, 2029 | 8 | 2024-2028, 2029 | 8 | 2024-2028, 2029 | 8 | 133 | 242 | 321 | 30 | 38 | 64 | |||||||
| Byetta (exenatide injection) | An injectable GLP-1RA indicated for adults with T2D. | expired | expired | expired | expired | 8 | 14 | 26 | 11 | 17 | 30 | |||||||||||
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Key Marketed products · Description · US · China · EU · Japan · 2023 · 2022 · 2021 · 2023 · 2022 · 2021 | ||||||||||||||||||||||
| Crestor (rosuvastatin calcium) | A statin for dyslipidaemia and hypercholesterolaemia. | expired | expired | expired | 2023 | 55 | 65 | 80 | | 1,052 | 983 | 1,016 | ||||||||||
| Farxiga/ Forxiga (dapagliflozin) | A sodium-glucose cotransporter 2 (SGLT-2 inhibitor) indicated for adult patients with T2D or in adults with or without T2D with heart failure with reduced ejection fraction or chronic kidney disease (CKD). | 2025, 2025-2040 | 2023, 2028-2041 | 2027 | 2024-2025, 2028 | 1,339 | 960 | 644 | 3,795 | 2,711 | 1,770 | |||||||||||
| Komboglyze/ Kombiglyze XR9 (saxagliptin/ metformin) | Combines saxagliptin and metformin as either Komboglyze, for T2D, or Kombiglyze XR, an extended release tablet for T2D. | 2023, 2025 | 2025 | 2026, 2025 | | 4 | 17 | 25 | 32 | 94 | 88 | 92 | ||||||||||
| Lokelma (sodium zirconium cyclosilicate) | An insoluble, non-absorbed sodium zirconium cyclosilicate, formulated as a powder for oral suspension, that acts as a highly selective potassium-removing agent for the treatment of hyperkalaemia. | 2032-2035 | 203310 -2034 | 2032 | 2 | 2032-2037 | 214 | 170 | 115 | 198 | 119 | 60 | ||||||||||
| Onglyza (saxagliptin) | An oral dipeptidyl peptidase 4 inhibitor for T2D. | 2023, 2028 | 2025 | 2024, 2025 | | 4 | 32 | 51 | 56 | 84 | 93 | 179 | ||||||||||
| Roxadustat11 | An oral hypoxia-inducible factor prolyl hydroxylase inhibitor indicated for the treatment of anaemia from CKD. | 2024, 2024-2034 | 2024, 2024-2033 | | 4 | | 4 | — | — | — | 271 | 197 | 174 | |||||||||
| Wainua (eplontersen) | Wainua injection, for subcutaneous use, is a prescription medicine used to treat adults with polyneuropathy of hereditary transthyretinmediated amyloidosis. | 2034 | 2034 | 2034 | 2034 | — | — | — | — | — | — | |||||||||||
| Xigduo/ Xigduo XR12 (dapagliflozin/ metformin) | Combines dapagliflozin and metformin as either Xigduo – to improve glycaemic control in adults with T2D who are inadequately controlled on metformin alone, or Xigduo XR – an extended release tablet for adults with T2D who are inadequately controlled on metformin alone. | 2025, 2025-2030 | 2023 | 2028 | 2024-2025, 2030 | 112 | 111 | 88 | 717 | 599 | 498 | |||||||||||
| Respiratory & Immunology | | | | | | | | | | | ||||||||||||
| Airsupra (albuterol/budesonide) | A first-in-class, fixed-dose combination rescue medication for asthma in the US containing a short-acting beta2-agonist (SABA) and an anti-inflammatory inhaled corticosteroid (ICS), for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations, developed in a pressurized metered-dose inhaler (pMDI) using AstraZeneca’s Aerosphere delivery technology. | 2030 | 2030 | | | 2030 | — | — | — | — | — | — | ||||||||||
| Bevespi Aerosphere (glycopyrrolate/formoterol) | A combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-agonist (LABA) delivered in a pressurised metered-dose inhaler (pMDI) used for the long-term maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD). | 2030-2031 | 2030 | 2030 | | 2030-2034 | 34 | 42 | 39 | 24 | 16 | 15 | ||||||||||
| Breztri/Trixeo Aerosphere (PT010) (budesonide/ glycopyrrolate/ formoterol) | A fixed-dose triple combination of an inhaled corticosteroid (ICS), a LAMA and a LABA delivered in a pMDI, used for the long-term maintenance treatment of COPD. | 2030-2031, 2038 | 2030, 2038 | 2030, 2038 | | 2030-2034, 2038 | 383 | 239 | 115 | 294 | 159 | 88 | ||||||||||
| Daliresp/ Daxas (roflumilast) | An oral phosphodiesterase-4 inhibitor for adults with severe COPD to decrease their number of exacerbations. | 2023-2024 | 2023 | 2023 | | expired | 42 | 176 | 207 | 12 | 13 | 20 | ||||||||||
| Fasenra (benralizumab) | A mAb which directly targets and depletes eosinophils by recruiting natural killer cells and inducing apoptosis (programmed cell death). Approved as an add-on maintenance treatment for severe eosinophilic asthma. | 2024, 2028-2034 | 2028 | 2025, 2028-2034 | | 2025, 2034 | 992 | 906 | 790 | 561 | 490 | 468 | ||||||||||
| Pulmicort (budesonide) | An ICS for maintenance treatment of asthma available as Turbuhaler and as Respules. | expired | expired | expired | | expired | 28 | 65 | 72 | 685 | 580 | 890 | ||||||||||
| Saphnelo (anifrolumab) | A first-in-class fully human mAb 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 driving the inflammatory pathways implicated in SLE. | 2025-2029, 2033-2036 | 2025-2029 | 2025-2029, 2036 | | 2030-2034, 2033-2036 | 260 | 111 | 8 | 20 | 5 | – | ||||||||||
| 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. | 2023- 2029 | 13 | expired | expired | | expired | 726 | 973 | 1,065 | 1,636 | 1,565 | 1,663 | |||||||||
| Tezspire14 (tezepelumab) | A first-in-class human mAb that inhibits the action of TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of airway inflammation and airway hyperresponsiveness in severe asthma. Approved for a broad population of severe asthma patients, without phenotype and biomarker limitation. Developed in collaboration with Amgen. | 2028, 2038 | 2028 | 2028 | | 2028, 2038 | — | — | — | 86 | 4 | – | ||||||||||
| Vaccines & Immune Therapies | | | | | | | | | | | | | | | | | | | | | | |
| Beyfortus (nirsevimab) | | A long-acting anti-RSV F mAb used to prevent RSV lower respiratory tract disease in neonates and infants during their first RSV season. Jointly developed and commercialised with Sanofi. | | 2028–2035, 2038 | | | | 2035 | | 2035, 2038 | | 87 | | — | | — | | 19 | | — | | — |
| Evusheld (tixagevimab co-packaged with cilgavimab) | | A combination of two long-acting antibodies, developed for the prevention and treatment of COVID-19. | | 2041 | | | | | | | | – | | 1,067 | | – | | 132 | | 1,118 | | 85 |
| 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 | | 2025 | 15 | 23 | | 21 | | 27 | | 193 | | 154 | | 226 |
| Synagis (palivizumab) | | A humanised mAb used to prevent serious lower respiratory tract disease caused by RSV in infants at high risk of acquiring RSV disease. | | 2023 | 16 | expired | | 2023 | | 2023 | | (1) | | 1 | | 23 | | 547 | | 577 | | 387 |
| Vaxzevria17 (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 | | — | | 79 | | 64 | | 12 | | 1,719 | | 3,853 |
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Key Marketed products · Description · US · China · EU · Japan · 2023 · 2022 · 2021 · 2023 · 2022 · 2021 | ||||||||||||||||||||||
| Rare Disease · · · · · · · · · · · · · · · · · · · · · | ||||||||||||||||||||||
| Kanuma (sebelipase alfa) | | A recombinant form of the human lysosomal acid lipase (LAL) enzyme, the enzyme replacement therapy is for the treatment of LAL deficiency. | | 2031 | | 2031 | | 2031, 2026-2037 | | 2031, 2032 | | 85 | | 77 | | 32 | | 86 | | 83 | | 30 |
| Koselugo (selumetinib) | | A specific enzymes-inhibitor which blocks mitogen-activated protein kinases (MEK1 and MEK2), which are involved in stimulating cells to grow. In neurofibromatosis type 1, these enzymes are overactive, causing tumour cells to grow in an unregulated way. By blocking these enzymes, Koselugo slows down the growth of tumour cells. | | 2023, 2023-2029 | | 2023, 2026-2029 | | 2023, 2026-2029 | | 2023, 2023-2029 | | 195 | | 162 | | 104 | | 136 | | 46 | | 4 |
| Soliris (eculizumab) | A C5 inhibitor for the treatment of paroxysmal nocturnal haemoglobinuria, atypical haemolytic uraemic syndrome, generalised myasthenia gravis and neuromyelitis optica spectrum disorder. | 2027, 2025-2032 | 18 | 2029 | 2029 | 19 | 2027, 2029 | 1,734 | 2,180 | 1,068 | 1,411 | 1,582 | 806 | |||||||||
| Strensiq (asfotase alfa) | | A targeted enzyme replacement therapy for patients with hypophosphatasia. | | 2025-2029, 2035-2038 | | | | 2025-2031, 2036 | | 2028, 2035-2036 | | 937 | | 769 | | 297 | | 215 | | 189 | | 81 |
| Ultomiris (ravulizumab) | A long-acting C5 inhibitor for the treatment of paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome, generalised myasthenia gravis and neuromyelitis optica spectrum disorder. | 2035, 2038 | 2035, 2038 | 2035, 2038-2039 | 2037, 2038 | 1,750 | 1,136 | 381 | 1,251 | 829 | 307 | |||||||||||
| Voydeya (danicopan) | An oral, Factor D inhibitor developed as add-on to proven standard-of-care Ultomiris or Soliris to address the needs of the subset of patients with PNH who experience clinically significant extravascular haemolysis while treated with a C5 inhibitor. | 2035 | 2035 | 2035 | 2035 | — | — | — | — | — | | — | ||||||||||
| Other | | | | | | | | | | | | |||||||||||
| Nexium20 (esomeprazole) | A proton pump inhibitor used to treat acid-related diseases. | expired | expired | expired | expired | 115 | 120 | 128 | 830 | 1,165 | 1,198 | |||||||||||
| * | 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). The patentee successfully defended the patent in that proceeding, but the opponents have appealed. |
| 3 | AstraZeneca has recorded $1,022 million of Alliance Revenue in relation to this product in 2023 (2022: $523 million; 2021: $197 million), as per “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” on pages 160 to 161 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024. |
| 4 | AstraZeneca does not have commercialisation rights. |
| 5 | Imjudo Product Sales are included in the Imfinzi Product Sales figure. |
| 6 | In addition to any Product Sales, AstraZeneca has also recorded $245 million of Collaboration Revenue in relation to this product in 2023 (2022: $355 million; 2021: $400 million), as per “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” on pages 160 to 161 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024. |
| 7 | Rights licensed to TerSera Therapeutics LLC in the US. |
| 8 | Patent expiry date relates to BCise. |
| 9 | Komboglyze/Kombiglyze XR revenue is included in the Onglyza Product Sales figure. |
| 10 | The patent is the subject of a pending invalidation proceeding at China National Intellectual Property Administration. |
| 11 | AstraZeneca has recorded $5 million of Collaboration Revenue in relation to this product in 2023 (2022: $5 million; 2021: $6 million), as per “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” on pages 160 to 161 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024. |
| 12 | Xigduo/Xigduo XR Product Sales are included in the Farxiga Product Sales figure. |
| 13 | Patent expiry information relates to the Symbicort pMDI product, including any granted Paediatric Exclusivity term. |
| 14 | AstraZeneca has recorded $259 million of Alliance Revenue in relation to this product in 2023 (2022: $79 million; 2021: $nil), as per “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” on pages 160 to 161 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024. |
| 15 | Rights licensed to Daiichi Sankyo, Inc. |
| 16 | Rights sold to Sobi. |
| 17 | AstraZeneca has recorded $nil of Alliance Revenue in relation to this product in 2023 (2022: $76 million; 2021: $64 million), as per “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” on pages 160 to 161 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024. |
| 18 | Settled with Amgen for licensed biosimilar entry date of 1 March 2025. The patents expiring in 2027 are the subject of pending inter partes review proceedings before the United States Patent Office. |
| 19 | The patent is the subject of a pending opposition proceeding at the EPO. Alexion has consented to revocation of this patent in the UK and has withdrawn this patent in the Netherlands. |
| 20 | AstraZeneca has recorded $nil of Collaboration Revenue in relation to this product in 2023 (2022: $62 million; 2021: $75 million), as per “Financial Statements—Notes to the Group Financial Statements—Note 1—Revenue” on pages 160 to 161 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024. |
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 · US · · Emerging Markets · Europe · Established ROW | ||||||||||||||||||||||||||||
| · Sales · Actual · · CER · · Sales · · Actual · · Sales · · Actual · · CER · · Sales · · Actual · · CER · · Sales · · Actual · · CER | ||||||||||||||||||||||||||||
| 2023 · · $m · % · % · $m · % · $m · % · % · $m · % · % · $m · % · % | ||||||||||||||||||||||||||||
| Oncology: | ||||||||||||||||||||||||||||
| Tagrisso | 5,799 | | 7 | | 9 | | 2,276 | | 13 | | 1,621 | | 3 | | 10 | | 1,120 | | 10 | | 8 | | 782 | | (8) | | (1) | |
| Imfinzi | 4,237 | | 52 | | 55 | | 2,317 | | 49 | | 360 | | 25 | | 39 | | 758 | | 39 | | 36 | | 802 | | n/m | | n/m | |
| Lynparza | 2,811 | | 7 | | 9 | | 1,254 | | 2 | | 542 | | 11 | | 21 | | 734 | | 12 | | 10 | | 281 | | 5 | | 12 | |
| Calquence | 2,514 | | 22 | | 23 | | 1,815 | | 10 | | 98 | | n/m | | n/m | | 493 | | 72 | | 69 | | 108 | | 58 | | 65 | |
| Enhertu | 261 | | n/m | | n/m | | — | | — | | 169 | | n/m | | n/m | | 60 | | n/m | | n/m | | 32 | | n/m | | n/m | |
| Orpathys | 44 | | 34 | | 42 | | — | | — | | 44 | | 34 | | 42 | | — | | — | | — | | — | | — | | — | |
| Truqap | 6 | | n/m | | n/m | | 6 | | n/m | | — | | — | | — | | — | | — | | — | | — | | — | | — | |
| Zoladex | 952 | | 3 | | 9 | | 14 | | (4) | | 687 | | 5 | | 12 | | 133 | | — | | (1) | | 118 | | (4) | | 2 | |
| Faslodex | 297 | | (11) | | (6) | | 31 | | 87 | | 142 | | (11) | | (6) | | 28 | | (49) | | (50) | | 96 | | (7) | | 1 | |
| Others | 224 | | (33) | | (30) | | 6 | | (44) | | 165 | | (34) | | (31) | | 6 | | (42) | | (41) | | 47 | | (28) | | (23) | |
| Total Oncology | 17,145 | | 17 | | 20 | | 7,719 | | 19 | | 3,828 | | 8 | | 16 | | 3,332 | | 22 | | 20 | | 2,266 | | 20 | | 29 | |
| BioPharmaceuticals: CVRM | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Farxiga | 5,963 | | 36 | | 39 | | 1,451 | | 35 | | 2,211 | | 33 | | 40 | | 1,881 | | 45 | | 42 | | 420 | | 21 | | 30 | |
| Brilinta | 1,324 | | (2) | | (1) | | 744 | | — | | 285 | | — | | 10 | | 271 | | (4) | | (5) | | 24 | | (49) | | (47) | |
| Lokelma | 412 | | 43 | | 46 | | 214 | | 26 | | 50 | | n/m | | n/m | | 58 | | 94 | | 91 | | 90 | | 32 | | 42 | |
| roxadustat | 271 | | 38 | | 45 | | — | | — | | 271 | | 38 | | 45 | | — | | — | | — | | — | | — | | — | |
| Andexxa* | 182 | | 21 | | 23 | | 75 | | (2) | | — | | — | | — | | 62 | | 50 | | 47 | | 45 | | 39 | | 50 | |
| Crestor | 1,107 | | 6 | | 11 | | 55 | | (16) | | 862 | | 9 | | 15 | | 52 | | 26 | | 25 | | 138 | | (7) | | - | |
| Seloken/Toprol-XL | 640 | | (26) | | (20) | | 1 | | n/m | | 621 | | (26) | | (20) | | 11 | | (18) | | (17) | | 7 | | (23) | | (19) | |
| Onglyza | 227 | | (12) | | (8) | | 49 | | (36) | | 131 | | 8 | | 16 | | 32 | | (16) | | (17) | | 15 | | (30) | | (28) | |
| Bydureon | 163 | | (42) | | (42) | | 133 | | (45) | | 3 | | 12 | | 12 | | 27 | | (24) | | (26) | | - | | - | | - | |
| Others | 296 | | (19) | | (17) | | 30 | | (10) | | 152 | | (22) | | (18) | | 109 | | (15) | | (15) | | 5 | | (52) | | (49) | |
| Total CVRM | 10,585 | | 15 | | 18 | | 2,752 | | 11 | | 4,586 | | 11 | | 18 | | 2,503 | | 31 | | 29 | | 744 | | 9 | | 16 | |
| BioPharmaceuticals: Respiratory & Immunology | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Symbicort | 2,362 | | (7) | | (4) | | 726 | | (25) | | 753 | | 24 | | 33 | | 549 | | (6) | | (7) | | 334 | | (11) | | (7) | |
| Fasenra | 1,553 | | 11 | | 12 | | 992 | | 9 | | 64 | | 50 | | 61 | | 355 | | 16 | | 14 | | 142 | | — | | 6 | |
| Breztri | 677 | | 70 | | 73 | | 383 | | 60 | | 161 | | 75 | | 85 | | 81 | | n/m | | n/m | | 52 | | 55 | | 66 | |
| Saphnelo | | 280 | | n/m | | n/m | | 260 | | n/m | | 2 | | n/m | | n/m | | 8 | | n/m | | n/m | | 10 | | n/m | | n/m |
| Tezspire | | 86 | | n/m | | n/m | | — | | — | | 1 | | n/m | | n/m | | 48 | | n/m | | n/m | | 37 | | n/m | | n/m |
| Pulmicort | 713 | | 11 | | 17 | | 28 | | (58) | | 575 | | 25 | | 34 | | 68 | | (1) | | (2) | | 42 | | (15) | | (10) | |
| Bevespi | 58 | | — | | — | | 34 | | (19) | | 6 | | 19 | | 28 | | 17 | | 65 | | 62 | | 1 | | 50 | | 14 | |
| Daliresp | 54 | | (72) | | (72) | | 42 | | (76) | | 3 | | (7) | | (11) | | 8 | | (9) | | (11) | | 1 | | (48) | | (20) | |
| Others | 324 | | (23) | | (20) | | 82 | | (42) | | 206 | | (10) | | (5) | | 30 | | (29) | | (30) | | 6 | | 1 | | 5 | |
| Total Respiratory & Immunology | 6,107 | | 6 | | 8 | | 2,547 | | (4) | | 1,771 | | 23 | | 31 | | 1,164 | | 10 | | 8 | | 625 | | 2 | | 8 | |
| BioPharmaceuticals: Vaccines & Immune Therapies | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| COVID-19 mAbs | 132 | | (94) | | (93) | | — | | n/m | | 6 | | (99) | | (99) | | 12 | | (96) | | (96) | | 114 | | (72) | | (68) | |
| Vaxzevria | 12 | | (99) | | (99) | | — | | n/m | | 10 | | (99) | | (99) | | 2 | | n/m | | (99) | | — | | n/m | | n/m | |
| Beyfortus | 106 | | n/m | | n/m | | 87 | | n/m | | — | | — | | — | | 19 | | n/m | | n/m | | — | | — | | — | |
| Synagis | 546 | | (6) | | (2) | | (1) | | n/m | | 195 | | 13 | | 19 | | 175 | | (18) | | (18) | | 177 | | (7) | | (1) | |
| FluMist | | 216 | | 24 | | 17 | | 23 | | 10 | | 1 | | 9 | | (2) | | 188 | | 25 | | 17 | | 4 | | 74 | | 80 |
| Total Vaccines & Immune Therapies | 1,012 | | (79) | | (78) | | 109 | | (91) | | 212 | | (84) | | (83) | | 396 | | (61) | | (62) | | 295 | | (76) | | (74) | |
| Rare Disease*: | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Soliris* | | 3,145 | | (16) | | (14) | | 1,734 | | (20) | | 424 | | 41 | | 63 | | 670 | | (17) | | (18) | | 317 | | (33) | | (29) |
| Ultomiris* | | 2,965 | | 51 | | 52 | | 1,750 | | 54 | | 71 | | 88 | | 89 | | 668 | | 39 | | 36 | | 476 | | 54 | | 65 |
| Strensiq* | | 1,152 | | 20 | | 21 | | 937 | | 22 | | 40 | | 15 | | 22 | | 89 | | 14 | | 11 | | 86 | | 13 | | 22 |
| Koselugo | | 331 | | 59 | | 60 | | 195 | | 20 | | 59 | | n/m | | n/m | | 53 | | n/m | | n/m | | 24 | | n/m | | n/m |
| Kanuma* | | 171 | | 7 | | 8 | | 85 | | 10 | | 29 | | (7) | | (1) | | 49 | | 12 | | 10 | | 8 | | 2 | | 9 |
| Total Rare Disease | | 7,764 | | 10 | | 12 | | 4,701 | | 9 | | 623 | | 45 | | 62 | | 1,529 | | 7 | | 5 | | 911 | | 5 | | 12 |
| Other medicines | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Nexium | 945 | | (27) | | (22) | | 115 | | (5) | | 578 | | 2 | | 9 | | 53 | | 16 | | 13 | | 199 | | (64) | | (61) | |
| Others | 231 | | (32) | | (30) | | 18 | | (22) | | 153 | | (31) | | (28) | | 52 | | (33) | | (32) | | 8 | | (58) | | (55) | |
| Total Other medicines | 1,176 | | (28) | | (24) | | 133 | | (8) | | 731 | | (7) | | (1) | | 105 | | (14) | | (15) | | 207 | | (64) | | (61) | |
| Total Product Sales | 43,789 | | 2 | | 4 | | 17,961 | | 4 | | 11,751 | | 1 | | 8 | | 9,029 | | 9 | | 7 | | 5,048 | | (14) | | (8) | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · World · US · · Emerging Markets · Europe · Established ROW | ||||||||||||||||||||||||||||
| · Sales · Actual · · CER · · Sales · · Actual · · Sales · · Actual · · CER · · Sales · · Actual · · CER · · Sales · · Actual · · CER | ||||||||||||||||||||||||||||
| 2022 · · $m · % · % · $m · % · $m · % · % · $m · % · % · $m · % · % | ||||||||||||||||||||||||||||
| Oncology: | ||||||||||||||||||||||||||||
| Tagrisso | 5,444 | | 9 | | 15 | | 2,007 | | 13 | | 1,567 | | 17 | | 22 | | 1,023 | | 4 | | 17 | | 847 | | (7) | | 8 | |
| Imfinzi | 2,784 | | 15 | | 21 | | 1,552 | | 25 | | 287 | | 4 | | 7 | | 544 | | 12 | | 26 | | 401 | | (1) | | 15 | |
| Lynparza | 2,638 | | 12 | | 18 | | 1,226 | | 13 | | 488 | | 27 | | 31 | | 655 | | 6 | | 19 | | 269 | | 4 | | 20 | |
| Calquence | 2,057 | | 66 | | 69 | | 1,657 | | 52 | | 45 | | n/m | | n/m | | 286 | | n/m | | n/m | | 69 | | n/m | | n/m | |
| Enhertu | 79 | | n/m | | n/m | | — | | — | | 51 | | n/m | | n/m | | 21 | | n/m | | n/m | | 7 | | n/m | | n/m | |
| Orpathys | | 33 | | n/m | | n/m | | — | | — | | 33 | | n/m | | n/m | | — | | — | | — | | — | | — | | — |
| Zoladex | 927 | | (2) | | 6 | | 15 | | 15 | | 657 | | 6 | | 12 | | 133 | | (10) | | 1 | | 122 | | (28) | | (15) | |
| Faslodex | 334 | | (22) | | (14) | | 17 | | (45) | | 159 | | (4) | | 3 | | 55 | | (52) | | (46) | | 103 | | (15) | | 1 | |
| Iressa | 114 | | (38) | | (34) | | 9 | | (19) | | 94 | | (38) | | (35) | | 2 | | (52) | | (41) | | 9 | | (44) | | (35) | |
| Arimidex | 99 | | (29) | | (24) | | — | | — | | 76 | | (29) | | (26) | | — | | (87) | | (86) | | 23 | | (23) | | (11) | |
| Casodex | 78 | | (45) | | (40) | | — | | — | | 53 | | (50) | | (47) | | 1 | | (49) | | (48) | | 24 | | (31) | | (19) | |
| Others | 44 | | (14) | | (6) | | 1 | | 59 | | 27 | | (6) | | 1 | | 6 | | (4) | | 4 | | 10 | | (36) | | (26) | |
| Total Oncology | | 14,631 | | 13 | | 19 | | 6,484 | | 23 | | 3,537 | | 10 | | 14 | | 2,726 | | 10 | | 23 | | 1,884 | | (5) | | 10 |
| BioPharmaceuticals: CVRM | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Farxiga | | 4,381 | | 46 | | 56 | | 1,071 | | 46 | | 1,665 | | 39 | | 47 | | 1,297 | | 60 | | 81 | | 348 | | 32 | | 49 |
| Brilinta | 1,358 | | (8) | | (4) | | 744 | | 1 | | 286 | | (13) | | (10) | | 282 | | (18) | | (8) | | 46 | | (27) | | (22) | |
| Lokelma | 289 | | 65 | | 75 | | 170 | | 47 | | 20 | | n/m | | n/m | | 30 | | n/m | | n/m | | 69 | | 55 | | 83 | |
| roxadustat | 197 | | 13 | | 18 | | — | | — | | 197 | | 13 | | 18 | | — | | — | | — | | — | | — | | — | |
| Andexxa* | 150 | | 5 | | 14 | | 77 | | (32) | | — | | — | | — | | 41 | | 41 | | 58 | | 32 | | n/m | | n/m | |
| Crestor | 1,048 | | (4) | | 2 | | 65 | | (19) | | 794 | | 2 | | 9 | | 41 | | (21) | | (12) | | 148 | | (21) | | (10) | |
| Seloken/Toprol-XL | 862 | | (9) | | (4) | | — | | n/m | | 839 | | (10) | | (4) | | 14 | | 26 | | 27 | | 9 | | (16) | | (13) | |
| Bydureon | 280 | | (27) | | (26) | | 242 | | (24) | | 3 | | (16) | | (18) | | 35 | | (37) | | (29) | | — | | (95) | | (94) | |
| Onglyza | 257 | | (28) | | (25) | | 76 | | (13) | | 121 | | (32) | | (28) | | 38 | | (37) | | (29) | | 22 | | (32) | | (30) | |
| Others | 366 | | (10) | | (7) | | 34 | | (35) | | 194 | | (1) | | 4 | | 128 | | (12) | | (10) | | 10 | | (32) | | (24) | |
| Total CVRM | 9,188 | | 13 | | 19 | | 2,479 | | 11 | | 4,119 | | 9 | | 15 | | 1,906 | | 25 | | 40 | | 684 | | 10 | | 25 | |
| BioPharmaceuticals: Respiratory & Immunology | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Symbicort | 2,538 | | (7) | | (2) | | 973 | | (9) | | 608 | | — | | 5 | | 582 | | (13) | | (3) | | 375 | | (2) | | 5 | |
| Fasenra | 1,396 | | 11 | | 15 | | 906 | | 15 | | 43 | | n/m | | n/m | | 305 | | 7 | | 20 | | 142 | | (12) | | (1) | |
| Breztri | 398 | | 96 | | n/m | | 239 | | n/m | | 92 | | 68 | | 75 | | 33 | | n/m | | n/m | | 34 | | 32 | | 56 | |
| Saphnelo | | 116 | | n/m | | n/m | | 111 | | n/m | | — | | — | | — | | 2 | | n/m | | n/m | | 3 | | n/m | | n/m |
| Tezspire | 4 | | n/m | | n/m | | — | | — | | — | | — | | — | | 2 | | n/m | | n/m | | 2 | | n/m | | n/m | |
| Pulmicort | 645 | | (33) | | (31) | | 65 | | (9) | | 462 | | (40) | | (39) | | 69 | | (6) | | 6 | | 49 | | 5 | | 15 | |
| Daliresp | 189 | | (17) | | (16) | | 176 | | (15) | | 3 | | (28) | | (24) | | 9 | | (39) | | (32) | | 1 | | 3 | | 7 | |
| Bevespi | 58 | | 7 | | 9 | | 42 | | 7 | | 5 | | 31 | | 38 | | 10 | | (7) | | 5 | | 1 | | n/m | | n/m | |
| Others | 421 | | (29) | | (27) | | 143 | | 32 | | 230 | | (20) | | (17) | | 42 | | (77) | | (75) | | 6 | | (53) | | (46) | |
| Total Respiratory & Immunology | 5,765 | | (4) | | — | | 2,655 | | 10 | | 1,443 | | (18) | | (14) | | 1,054 | | (15) | | (5) | | 613 | | (3) | | 7 | |
| BioPharmaceuticals: Vaccines & Immune Therapies | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Vaxzevria | 1,798 | | (54) | | (52) | | 79 | | 24 | | 729 | | (67) | | (67) | | 365 | | (65) | | (61) | | 625 | | 8 | | 17 | |
| Evusheld | | 2,185 | | n/m | | n/m | | 1,067 | | n/m | | 413 | | n/m | | n/m | | 298 | | n/m | | n/m | | 407 | | n/m | | n/m |
| Synagis | 578 | | 41 | | 59 | | 1 | | (94) | | 173 | | n/m | | n/m | | 213 | | 5 | | 17 | | 191 | | 28 | | 51 | |
| FluMist | | 175 | | (31) | | (20) | | 21 | | (21) | | 1 | | (51) | | (54) | | 151 | | (32) | | (20) | | 2 | | (4) | | (10) |
| Total Vaccines & Immune Therapies | 4,736 | | 2 | | 8 | | 1,168 | | n/m | | 1,316 | | (43) | | (41) | | 1,027 | | (33) | | (24) | | 1,225 | | 68 | | 89 | |
| Rare Disease*: | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Soliris* | 3,762 | | (11) | | (5) | | 2,180 | | (7) | | 301 | | (29) | | (10) | | 805 | | (21) | | (12) | | 476 | | 11 | | 24 | |
| Ultomiris* | 1,965 | | 34 | | 42 | | 1,136 | | 35 | | 38 | | n/m | | n/m | | 481 | | 49 | | 68 | | 310 | | 6 | | 26 | |
| Strensiq* | 958 | | 16 | | 18 | | 769 | | 19 | | 35 | | 41 | | 31 | | 78 | | (3) | | 9 | | 76 | | (1) | | 16 | |
| Koselugo | 208 | | 93 | | 96 | | 162 | | 55 | | 26 | | n/m | | n/m | | 20 | | n/m | | n/m | | — | | — | | — | |
| Kanuma* | 160 | | 16 | | 19 | | 77 | | 12 | | 31 | | 73 | | 61 | | 44 | | (3) | | 10 | | 8 | | 21 | | 38 | |
| Total Rare Disease | | 7,053 | | 4 | | 10 | | 4,324 | | 8 | | 431 | | (10) | | 6 | | 1,428 | | (3) | | 9 | | 870 | | 8 | | 24 |
| Other medicines | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Nexium | | 1,285 | | (3) | | 8 | | 120 | | (6) | | 568 | | (19) | | (13) | | 46 | | (26) | | (17) | | 551 | | 28 | | 50 |
| Others | | 340 | | (10) | | (7) | | 24 | | (45) | | 220 | | 4 | | 7 | | 77 | | (29) | | (27) | | 19 | | 37 | | 54 |
| Total Other medicines | | 1,625 | | (5) | | 4 | | 144 | | (16) | | 788 | | (14) | | (9) | | 123 | | (28) | | (24) | | 570 | | 28 | | 50 |
| Total Product Sales | | 42,998 | | 18 | | 24 | | 17,254 | | 44 | | 11,634 | | (4) | | 1 | | 8,264 | | 9 | | 22 | | 5,846 | | 22 | | 40 |
From 1 January 2022, the Group reportedAndexxa in CVRM,Koselugo in Rare Disease andSynagis andFlumist in Vaccines & Immune Therapies. In the “Sales by Region in 2023” section below, the 2023 figures and the comparative 2022 figures for these products are presented within their current therapy areas.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · World · · US · · Emerging Markets · · Europe · · Established ROW | ||||||||||||||||||||||||||||
| · · Sales · · Actual · · CER · · Sales · · Actual · · Sales · · Actual · CER · · Sales · · Actual · · CER · · Sales · · Actual · · CER | ||||||||||||||||||||||||||||
| 2021 | $m | % | % | $m | % | $m | % | % | $m | % | % | $m | % | % | ||||||||||||||
| Oncology: | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Tagrisso | | 5,015 | | 16 | | 13 | | 1,780 | | 14 | | 1,336 | | 11 | | 6 | | 986 | | 32 | | 25 | | 913 | | 13 | | 14 |
| Imfinzi | | 2,412 | | 18 | | 16 | | 1,245 | | 5 | | 277 | | 76 | | 68 | | 485 | | 31 | | 25 | | 405 | | 23 | | 23 |
| Lynparza | | 2,348 | | 32 | | 30 | | 1,087 | | 24 | | 384 | | 45 | | 41 | | 618 | | 42 | | 35 | | 259 | | 29 | | 28 |
| Calquence | | 1,238 | | n/m | | n/m | | 1,089 | | n/m | | 20 | | n/m | | n/m | | 111 | | n/m | | n/m | | 18 | | n/m | | n/m |
| Koselugo | | 108 | | n/m | | n/m | | 104 | | n/m | | 1 | | n/m | | 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 | | 13 | | n/m | | 619 | | 10 | | 5 | | 147 | | 5 | | (1) | | 169 | | (7) | | (7) |
| Faslodex | | 431 | | (26) | | (27) | | 30 | | (46) | | 167 | | (8) | | (10) | | 113 | | (49) | | (52) | | 121 | | (2) | | (1) |
| Iressa | | 183 | | (32) | | (35) | | 11 | | (23) | | 151 | | (31) | | (35) | | 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 | | 5,359 | | 26 | | 3,223 | | 11 | | 6 | | 2,484 | | 28 | | 22 | | 1,982 | | 13 | | 13 |
| BioPharmaceuticals: CVRM | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Farxiga | | 3,000 | | 53 | | 49 | | 732 | | 29 | | 1,195 | | 74 | | 70 | | 810 | | 60 | | 52 | | 263 | | 34 | | 31 |
| Brilinta | | 1,472 | | (8) | | (10) | | 735 | | 1 | | 328 | | (29) | | (31) | | 346 | | 1 | | (4) | | 63 | | 8 | | (1) |
| Bydureon | | 385 | | (14) | | (15) | | 321 | | (16) | | 3 | | (25) | | (26) | | 55 | | 5 | | — | | 6 | | (40) | | (44) |
| Onglyza | | 360 | | (23) | | (26) | | 88 | | (47) | | 179 | | (11) | | (14) | | 61 | | 5 | | (1) | | 32 | | (29) | | (33) |
| Byetta | | 55 | | (19) | | (19) | | 26 | | (31) | | 12 | | 61 | | 75 | | 11 | | (20) | | (25) | | 6 | | (36) | | (38) |
| Other diabetes | | 59 | | 26 | | 24 | | 22 | | (12) | | 18 | | n/m | | n/m | | 17 | | 35 | | 31 | | 2 | | 11 | | 12 |
| Lokelma | | 175 | | n/m | | n/m | | 115 | | n/m | | 3 | | (44) | | (48) | | 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) | | 80 | | (13) | | 775 | | 4 | | — | | 52 | | (60) | | (62) | | 189 | | (11) | | (10) |
| Seloken/Toprol-XL | | 951 | | 16 | | 10 | | 1 | | (89) | | 928 | | 19 | | 13 | | 11 | | (33) | | (33) | | 11 | | 9 | | (3) |
| Atacand | | 97 | | (60) | | (60) | | 4 | | (65) | | 28 | | (84) | | (84) | | 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 | | 2,124 | | 2 | | 3,780 | | 18 | | 14 | | 1,494 | | 22 | | 16 | | 622 | | 7 | | 5 |
| BioPharmaceuticals: Respiratory & Immunology | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Symbicort | | 2,728 | | — | | (2) | | 1,065 | | 4 | | 609 | | 7 | | 4 | | 670 | | (3) | | (8) | | 384 | | (12) | | (17) |
| Fasenra | | 1,258 | | 33 | | 31 | | 790 | | 31 | | 20 | | 67 | | 67 | | 286 | | 41 | | 34 | | 162 | | 24 | | 22 |
| Pulmicort | | 962 | | (3) | | (8) | | 72 | | 1 | | 770 | | (3) | | (9) | | 73 | | - | | (5) | | 47 | | (13) | | (15) |
| Daliresp | | 227 | | 5 | | 4 | | 207 | | 9 | | 4 | | — | | (2) | | 15 | | (32) | | (37) | | 1 | | (3) | | (10) |
| Breztri | | 203 | | n/m | | n/m | | 115 | | n/m | | 55 | | n/m | | n/m | | 7 | | n/m | | n/m | | 26 | | n/m | | n/m |
| Bevespi | | 54 | | 12 | | 12 | | 39 | | (11) | | 4 | | n/m | | n/m | | 11 | | n/m | | n/m | | — | | — | | — |
| Saphnelo | | 8 | | n/m | | n/m | | 8 | | — | | — | | — | | — | | — | | — | | — | | — | | — | | — |
| Others | | 594 | | 49 | | 42 | | 108 | | n/m | | 287 | | 41 | | 32 | | 185 | | 5 | | — | | 14 | | 1 | | (6) |
| Total Respiratory & Immunology | | 6,034 | | 13 | | 9 | | 2,404 | | 24 | | 1,749 | | 9 | | 4 | | 1,247 | | 6 | | 1 | | 634 | | (2) | | (5) |
| Rare Disease*: | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Soliris* | | 1,874 | | 1 | | 2 | | 1,068 | | 4 | | 170 | | 1 | | 8 | | 439 | | (8) | | (7) | | 197 | | 8 | | 11 |
| Ultomiris* | | 688 | | 27 | | 29 | | 381 | | 20 | | 9 | | n/m | | n/m | | 169 | | 73 | | 74 | | 129 | | 4 | | 11 |
| Strensiq* | | 378 | | 13 | | 13 | | 297 | | 13 | | 10 | | 81 | | 78 | | 36 | | 2 | | 3 | | 35 | | 9 | | 14 |
| Andexxa* | | 68 | | (3) | | (3) | | 50 | | (21) | | — | | — | | — | | 18 | | 7 | | 6 | | — | | — | | — |
| Kanuma* | | 62 | | 20 | | 21 | | 32 | | 13 | | 7 | | n/m | | n/m | | 20 | | 7 | | 9 | | 3 | | 14 | | 25 |
| Total Rare Disease | | 3,070 | | 8 | | 9 | | 1,828 | | 8 | | 196 | | 11 | | 18 | | 682 | | 7 | | 9 | | 364 | | 7 | | 11 |
| Other medicines | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Nexium | | 1,326 | | (11) | | (12) | | 128 | | (24) | | 705 | | (7) | | (10) | | 62 | | (13) | | (18) | | 431 | | (13) | | (12) |
| Synagis | | 410 | | 10 | | 13 | | 23 | | (51) | | 35 | | — | | — | | 203 | | (38) | | (37) | | 149 | | — | | — |
| Flumist | | 253 | | (14) | | (17) | | 27 | | (62) | | 2 | | 15 | | 2 | | 222 | | 1 | | (2) | | 2 | | (50) | | (53) |
| Losec/Prilosec | | 180 | | (2) | | (7) | | 1 | | (89) | | 152 | | — | | (7) | | 26 | | 32 | | 31 | | 1 | | (82) | | (72) |
| Seroquel XR/IR | | 92 | | (21) | | (20) | | 12 | | (30) | | 46 | | (17) | | (15) | | 29 | | 2 | | 2 | | 5 | | (71) | | (67) |
| Others | | 106 | | (16) | | (19) | | 30 | | (45) | | 14 | | n/m | | n/m | | 54 | | (5) | | (9) | | 8 | | (13) | | (19) |
| Total Other medicines | | 2,367 | | (8) | | (10) | | 221 | | (39) | | 954 | | (2) | | (5) | | 596 | | (17) | | (19) | | 596 | | 12 | | 15 |
| COVID-19 | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Vaxzevria | | 3,917 | | n/m | | n/m | | 64 | | n/m | | 2,240 | | n/m | | 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 | | 64 | | n/m | | 2,259 | | n/m | | n/m | | 1,101 | | n/m | | n/m | | 578 | | n/m | | n/m |
| Total Product Sales | | 36,541 | | 41 | | 38 | | 12,000 | | 39 | | 12,161 | | 40 | | 36 | | 7,604 | | 50 | | 44 | | 4,776 | | 36 | | 36 |
| * | 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. |
|---|
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 232 to 235 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024.
2023 in brief
Product Sales increased by 2% (CER: 4%) in 2023 to $43,789 million (2022: $42,998 million; 2021: $36,541 million) despite a decline of $3,839 million from Covid-19 medicine. Following completion of the Alexion acquisition on 21 July 2021, Rare Disease medicines generated $7,764 million in 2023, growing 10% (CER: 12%) as compared to 2022 and contributing 18% of AstraZeneca’s Total Product Sales.
Product Sales in the US increased by 4% to $17,961 million (2022: $17,254 million; 2021: $12,000 million) driven by strong performance of Oncology, CVRM and Rare Disease medicines. Sales of Rare Disease medicines in the US increased by 9% to $4,701 million (2022: $4,324 million, 2021: $1,882 million), representing 61% of total Rare Disease sales. This is largely driven by Product Sales ofUltomiris.
In 2023, Product Sales in Emerging Markets increased by 1% (CER: 8%) to $11,751 million (2022: $11,634 million; 2021: $12,161 million). Excluding COVID-19 medicines, Product Sales in Emerging Markets increased by 12% (CER: 20%) in the year to $11,735 million. China sales, comprising 50% of Emerging Markets sales, increased by 2% (CER: 8%) to $5,867 million (2022: $5,740 million; 2021: $5,995 million). This contributed to 13% of Product Sales in 2023.
Ex-China Emerging Markets Product Sales were stable at $5,884 million (increase of 8% at CER) (2022: $5,894 million; 2021: $6,166 million). Excluding COVID-19 medicines, Product Sales in Ex-China Emerging Markets increased by 23% in the year (CER: 34%) to $5,868 million, driven by Oncology medicines andFarxiga from CVRM. Product Sales ofVaxzevria in Ex-China Emerging Markets decreased by 99% (CER: 99%) to $10 million (2022: $729 million; 2021: $2,240 million) in the year. Product Sales ofCOVID-19 mAbs in Ex-China Emerging Markets decreased by 99% (CER: 99%) to $6 million (2022: $411 million; 2021: $19 million) in the year.
Product Sales in Europe increased by 9% (CER: 7%) to $9,029 million (2022: $8,264 million; 2021: $7,604 million). Sales of Rare Disease medicines comprised 17% of Europe Product Sales, which increased by 7% (CER: 5%) to $1,529 million in 2023. Oncology sales in Europe grew by 22% (CER: 20%) to $3,332 million (2022: $2,726 million; 2021: $2,484 million) and represented 37% of Europe sales, primarily driven by sales ofTagrisso,Lynparza andImfinzi. Excluding*COVID-19 medicines,*Product Sales in Europe grew by 19% (CER: 16%) to $9,015 million.
Product Sales in the Established ROW region decreased by 14% (CER: 8%) to $5,048 million (2022: $5,846 million; 2021: $4,776 million) largely driven by the decline in Vaccines and Immune Therapies. Japan, comprising 72% of total Established ROW Product Sales, decreased by 9% (CER: 1%) to $3,654 million (2022: $4,007 million; 2021: $3,416 million), due to the decline in sales of COVID-19 medicines*, SolirisandNexium.*Product Sales in Canada, which contributed 19% of total Established ROW Product Sales, decreased by 17% (CER: 14%) to $967 million (2022: $1,165 million; 2021: $772 million).
2022 in brief
Product Sales increased by 18% (CER: 24%) in 2022 to $42,998 million (2021: $36,541 million) including Vaccines & Immune Therapies revenues. Following completion of the Alexion acquisition on 21 July 2021, Rare Disease medicines generated $7,053 million, growing 4% (CER: 10%) on a pro-rata basis, and contributed to 16% of AstraZeneca’s Total Product Sales.
Product Sales in the US increased by 44% to $17,254 million (2021: $12,000 million) driven by strong performance of Oncology and CVRM medicines. Sales of Rare Disease medicines in the US increased to $4,324 million, representing 61% of total Rare Disease sales. This is largely driven by Product Sales ofUltomiris.
In 2022, Product Sales in Emerging Markets decreased by 4% (CER: increase of 1%) to $11,634 million (2021: $12,161 million). ExcludingVaxzevria, Product Sales in Emerging Markets increased by 10% (16% at CER) in the year to $10,905 million. China sales, comprising 49% of Emerging Markets sales, decreased by 4% (CER: 1%) to $5,740 million (2021: $5,995 million). This contributed to 13% of Product Sales in 2022.
Ex-China Emerging Markets Product Sales decreased by 4% (increase of 2% at CER) to $5,894 million (2021: $6,166 million). ExcludingVaxzevria sales, Product Sales in Ex-China Emerging Markets increased by 32% in the year (CER: 42%) to $5,165 million, driven by Oncology medicines andFarxiga from CVRM. Product Sales ofVaxzevria in Ex-China Emerging Markets generated $729 million in the year. Product Sales ofEvusheld in Ex-China Emerging Markets generated $411 million in the year.
Product Sales in Europe increased by 9% (CER: 22%) to $8,264 million (2021: $7,604 million). Sales of Rare Disease medicines comprised 17% of Europe Product Sales, which decreased on a pro rata basis by 3% (CER: 9%) to $1,428 million in 2022. Oncology sales in Europe grew by 10% (CER: 23%) to $2,726 million (2021: $2,484 million) and represented 33% of Europe sales, primarily driven by sales ofTagrisso,Lynparza andImfinzi.VaxzevriaProduct Sales contributed $365 million, amounting to 4% of total Europe Product Sales and 20% to the totalVaxzevriaProduct Sales in 2022. Excluding*Vaxzevria,*Product Sales in Europe grew by 20% (35% at CER) to $7,899 million.
Product Sales in the Established ROW region increased by 22% (CER: 40%) to $5,846 million (2021: $4,776 million) largely driven bySolirisandFarxiga. Japan, comprising 69% of total Established ROW Product Sales, increased by 17% (CER: 39%) to $4,007 million (2021: $3,416 million), underpinned by sales ofVaxzevria,Evusheldand*Nexium.*Product Sales in Canada, which contributed 20% of total Established ROW Product Sales, increased by 51% (CER: 57%) to $1,165 million (2021: $772 million).
From 1 January 2022, the Group reportedAndexxa in CVRM,Koselugo in Rare Disease andSynagis andFlumist in Vaccines & Immune Therapies. In the “Sales by Region in 2023” section below, the 2023 figures and the comparative 2022 figures for these products are presented within their current therapy areas.
2021 in brief
Product Sales increased by 41% (CER: 38%) in 2021 to $36,541 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. ExcludingVaxzevria, 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. 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. ExcludingVaxzezria sales, Product Sales in Ex-China Emerging Markets increased by 18% in the year (CER: 19%) to $3,926 million, driven by Oncology medicines andFarxiga. Product Sales ofVaxzevria in Ex-China Emerging Markets generated $2,240 million in the year.
Sales in the U.S. increased by 39% to $12,000 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 ofSoliris.
Product Sales in Europe increased by 50% (CER: 44%) to $7,604 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 and represented 33% of Europe sales, primarily driven by sales ofTagrisso,Lynparza andImfinzi.Vaxzevriasales contributed $1,035 million, amounting to 14% of total Europe Product Sales and 26% to the totalVaxzevria 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 largely driven byTagrisso andImfinzi. Japan, comprising 72% of total Established ROW sales, increased by 31% (CER: 35%) to $3,416 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. Other Established ROW sales increased by 90% (CER: 76%) to $588 million in the year, largely driven byVaxzevria.*
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.
Sales by Region in 2023
US
Product Sales in the US increased by 4% to $17,961 million (2022: $17,254 million; 2021: $12,000 million).
Oncology sales in the US increased by 19% to $7,719 million (2022: $6,484 million; 2021: $5,255 million).
Tagrisso sales in the US increased by 13% to $2,276 million (2022: $2,007 million; 2021: $1,780 million). Performance benefitted from continued adjuvant and 1st-line demand growth.
Imfinzi sales in the US increased by 49% to $2,317 million (2022: $1,552 million; 2021: $1,245 million), benefitting from continued demand growth from new launches in GI, including BTC (TOPAZ-1) and HCC Stage IV NSCLC.
Lynparza sales in the US grew by 2% to $1,254 million (2022: $1,226 million; 2021: $1,087 million) as a result of increased growth within PARP inhibitor class, offset by declining class use following the label restriction in 2nd-line ovarian cancer effective September 2023.
Calquence sales in the US exhibited a strong performance with an increase of 10% to $1,815 million (2022: $1,657 million; 2021: $1,089 million), as a result of sustained BTKi leadership across front-line and relapsed refractory CLL, partly offset by continued GtN pressure within competitive class.
Truqap sales in the US were $6 million (2022: $nil; 2021: $nil), as a result of the US approval on 16 th November 2023 in 2 nd-line+ HR+ breast cancer.
Faslodex sales in the US increased by 87% to $31 million (2022: $17 million; 2021: $30 million).
CVRM
CVRM sales in the US increased by 11% to $2,752 million (2022: $2,479 million; 2021: $2,174 million).
In the USFarxiga sales grew by 35% to $1,451 million (2022: $1,071 million; 2021: $732 million), with the growth driven by heart failure and CKD for patients with and without type 2 diabetes resulting in an increasing market share. There was also favourable gross-to-net adjustment in Q4 2023.
Brilinta sales in the US was $744 million (2022: $744 million; 2021: $735 million), with volume growth driven by longer duration of treatment.
Lokelma sales in the US increased by 26% to $214 million (2022: $170 million; 2021: $115 million), reflecting strong demand growth.
Andexxasales in the US declined by 2% to $75 million (2022: $77 million; 2021: $50 million).
Crestor sales in the US decreased by 16% to $55 million (2022: $65 million; 2021: $80 million).
U.S sales ofOnglyza fell by 36% in the year to $49 million (2022: $76 million; 2021: $88 million) due to continued decline for DPP-IV class.
Bydureon sales in the US declined by 45% to $133 million (2022: $242 million; 2021: $321 million) due to continued competitive pressures.
Respiratory & Immunology sales in the US decreased by 4% to $2,547 million (2022: $2,655 million; 2021: $2,404 million).
Symbicort sales in the US decreased by 25% to $726 million (2022: $973 million; 2021: $1,065 million) due to generic competition entering the US market in the third quarter of 2023.
Fasenra sales in the US increased by 9% to $992 million (2022: $906 million; 2021: $790 million), benefiting from maintained share of a growing market, leading to strong volume growth.
Breztri sales in the US increased by 60% to $383 million (2022: $239 million; 2021: $115 million), following consistent share growth within the FDC triple class in new-to-brand and the total market.
Saphnelo sales in the US amounted to $260 million (2022: $111 million; 2021: $8 million) as a result of demand acceleration in the US.
Pulmicort sales in the US decreased by 58% to $28 million (2022: $65 million; 2021: $72 million).
Bevespi sales in the US decreased by 19% to $34 million (2022: $42 million; 2021: $39 million).
Daliresp/Daxas sales in the US decreased by 76% to $42 million (2022: $176 million; 2021: $207 million), impacted by uptake of multiple generics following loss of exclusivity in the US
Vaccine & Immune Therapies in the US decreased by 91% to $109 million (2022: $1,168 million; 2021: $114 million), driven by a decline in sales of COVID-19 medicines.
COVID-19 mAbs sales in the US were $nil (2022: $1,067 million; 2021: $nil).
Vaxzevria sales in the US were $nil (2022: $79 million; 2021: $64 million), due to the fulfilment of contracts signed during the COVID-19 pandemic period.
Beyfortus sales in the US were $87 million (2022: $nil; 2021: $nil), as a result of AstraZeneca’s sales of manufacturedBeyfortusproduct to Sanofi.
FluMistsales in the US increased by 10% to $23 million in the year (2022: $21 million; 2021: $27 million).
Rare Disease sales in the US increased by 9% to $4,701 million (2022: $4,324 million; 2021: $1,882 million).
Soliris sales in the US decreased by 20% to $1,734 million (2022: $2,180 million; 2021: $1,068 million), driven by successful conversion ofSoliris patients toUltomiris in PNH, aHUS and gMG, partially offset bySoliris growth in NMOSD.
Ultomiris sales in the US increased by 54% to $1,750 million (2022: $1,136 million; 2021: $381 million), as a result of growth in naïve patients in gMG as well as successful conversion fromSoliris across shared indications.
Strensiqsales in the US increased by 22% to $937 million (2022: $769 million; 2021: $297 million). Performance benefitted from strong patient demand.
Koselugo sales in the US increased by 20% to $195 million (2022: $162 million; 2021: $104 million;) driven by patient demand.
Kanumasales in the US increased by 10% to $85 million (2022: $77 million; 2021: $32 million).
Other
Other medicines sales in the US decreased by 8% to $133 million (2022: $144 million; 2021: $171 million).
Nexium sales in the US decreased by 5% to $115 million (2022: $120 million; 2021: $128 million).
Emerging Markets
Product Sales in Emerging Markets increased by 1% (CER: 8%) to $11,751 million (2022: $11,634 million; 2021: $12,161 million).
Oncology sales in Emerging Markets increased by 8% (CER: 16%) to $3,828 million (2022: $3,537 million; 2021: $3,222 million).
Tagrisso sales in Emerging Markets increased by 3% (CER: 10%) to $1,621 million (2022: $1,567 million; 2021: $1,336 million), as a result of continued demand growth partly offset by anticipated seasonality from hospital ordering dynamic in China.
Imfinzi sales in Emerging Markets increased by 25% (CER: 39%) to $360 million (2022: $287 million; 2021: $277 million) as a result of increased demand for new launches including BTC as well as continued demand for legacy indications Stage III unresectable NSCLC (PACIFIC), SCLC (CASPIAN).
Lynparza sales in Emerging Markets increased by 11% (CER: 21%) to $542 million (2022: $488 million; 2021: $384 million), benefiting from increased demand, offset by price reduction in China associated with NRDL renewal that took effect March 2023 for ovarian cancer indications (PSR and BRCAm 1st-line maintenance) and new NRDL enlistment in prostate cancer (PROfound).
Calquencesales in Emerging Markets were $98 million (2022: $45 million; 2021: $20 million).
Enhertusales in Emerging Markets increased to $169 million (2022: $51 million; 2021: $12 million), as a result of continued uptake driven by approvals and launches, including strong demand growth in China following HER2-positive (DESTINY-Breast03) and HER2-low (DESTINY-Breast04) metastatic breast cancer launches.
Orpathys sales in Emerging Markets increased by 34% (CER: 42%) to $44 million (2022: $33 million; 2021: $16 million), due to its inclusion in the NRDL in China from March 2023 for the treatment of patients with NSCLC with MET exon 14 skipping alterations.
Zoladex sales in Emerging Markets increased by 5% (CER: 12%) to $687 million (2022: $657 million; 2021: $619 million) driven by strong underlying growth in China.
Faslodexsales in Emerging Markets fell by 11% (CER: 6%) to $142 million (2022: $159 million; 2021: $167 million) due to decline in China sales in fourth quarter due to supply issues, a consequence of short lead time of supply replenishment following VBP timeline changes.
CVRM
CVRM sales in Emerging Markets increased by 11% (CER: 18%) to $4,586 million (2022: $4,119 million; 2021: $3,780 million).
Forxiga sales in Emerging Markets increased by 33% (CER: 40%) to $2,211 million (2022: $1,665 million; 2021: $1,195 million) driven by solid growth despite generic competition in some markets and good momentum in Latin America.
Emerging Markets sales ofBrilintawere stable at $285 million (CER: increase of 10%) (2022: $286 million; 2021: $328 million) and is holding positioning despite generics pressure.
Emerging Markets sales of roxadustat increased by 38% to $271 million (2022: $197 million; 2021: $174 million), benefitting from increased demand in both the dialysis- and non-dialysis-dependent populations as well as renewed NRDL listing.
Crestor sales in Emerging Markets increased by 9% (CER: 15%) to $862 million (2022: $794 million; 2021: $775 million).
Selokensales in Emerging Markets declined by 26% (CER: 20%) to $621 million (2022: $839 million; 2021: $928 million).
Onglyza sales in Emerging Markets increased by 8% (CER: 16%) to $131 million (2022: $121 million; 2021: $179 million).
Bydureonsales in Emerging Markets increased by 12% (CER: 12%) to $3 million (2022: $3 million; 2021: $3 million).
Respiratory & Immunology sales in Emerging Markets increased by 23% (CER: 31%) to $1,771 million (2022: $1,443 million; 2021: $1,749 million).
Emerging Markets sales ofSymbicortincreased by 24% (CER: 33%) to $753 million (CER: 5%) in the year (2022: $608 million; 2021: $609 million), as a result of strong underlying demand.
Fasenrasales in Emerging Markets increased by 50% (CER: 61%) to $64 million (2022: $43 million; 2021: $20 million) as a result of continued strong volume growth driven by launch acceleration across key markets.
Breztrisales in Emerging Markets increased by 75% (CER: 85%) to $161 million (2022: $92 million; 2021: $55 million) as a result of maintaining market share leadership in China with strong triple FDC class penetration.
Pulmicort sales in Emerging Markets increased by 25% (CER: 34%) to $575 million (2022: $462 million; 2021: $770 million) largely as a result of stabilized market share in China, with VBP having been in effect for over 12 months.
Bevespi sales in Emerging Markets increased by 19% (CER: 28%) to $6 million during the year (2022: $5 million; 2021: $4 million).
Daliresp sales in Emerging Markets declined by 7% (CER: 11%) to $3 million (2022: $3 million; 2021: $4 million).
Vaccines & Immune Therapies in Emerging Markets decreased by 84% (CER: 83%) to $212 million (2022: $1,316 million; 2021: $2,295 million).
COVID-19 mAbs sales in Emerging Markets decreased by 99% (CER: 99%) to $6 million (2022: $413 million; 2021: $19 million) and all sales were derived from sales ofEvusheld.
Vaxzevria sales in Emerging Markets declined by 99% (CER: 99%) to $10 million (2022: $729 million; 2021: $2,240 million) due to the fulfilment of contracts signed during the COVID-19 pandemic.
Synagis sales in Emerging Markets increased by 13% (CER: 19%) to $195 million (2022: $173 million; 2021: $35 million), indicating that performance is broadly in line with prior year.
Rare Disease sales in Emerging Markets increased by 45% (CER: 62%) to $623 million (2022: $431 million; 2021: $197 million).
Soliris sales in the Emerging Markets increased by 41% (CER: 63%) to $424 million (2022: $301 million; 2021: $170 million), as a result of growth following new market launches.
Ultomiris sales in the Emerging Markets increased by 88% (CER: 89%) to $71 million (2022: $38 million; 2021: $9 million), as a result of continued growth following launches in new markets.
Strensiq sales in the Emerging Markets increased by 15% (CER: 22%) to $40 million (2022: $35 million; 2021: $10 million), as a result of growth driven by strong demand.
Koselugo sales in the Emerging Markets increased to $59 million (2022: $26 million; 2021: $1 million), as a result of patient demand and expansion in new markets.
Kanuma sales in the Emerging Markets decreased by 7% (CER: 1%) to $29 million (2022: $31 million; 2021: $7 million).
Other
Other medicines sales in Emerging Markets decreased by 7% (CER: 1%) to $731 million (2022: $788 million; 2021: $917 million).
Nexium sales in Emerging Markets increased by 2% (CER: 9%) to $578 million (2022: $568 million; 2021: $705 million).
Europe
Product Sales in Europe increased by 9% (CER: 7%) to $9,029 million (2022: $8,264 million; 2021: $7,604 million).
Oncology sales in Europe increased by 22% (CER: 20%) to $3,332 million (2022: $2,726 million; 2021: $2,481 million).
Tagrisso sales in Europe increased by 10% (CER: 8%) to $1,120 million (2022: $1,023 million; 2021: $986 million), driven by continued growth in 1 st-line setting and increasing adjuvant demand.
Imfinzi sales in Europe increased by 39% (CER: 36%) to $758 million (2022: $544 million; 2021: $485 million), as a result of competitive share gain in SCLC, and expanded reimbursement for BTC, HCC, Stage IV NSCLC and SCLC.
Lynparza sales in Europe increased by 12% (CER: 10%) to $734 million (2022: $655 million; 2021: $618 million), as a result of demand growth from increased uptake and new launches in 1st-line HRD-positive ovarian cancer (PAOLA-1), gBRCAm10 HER2-negative early breast cancer (OlympiA) and mCRPC (PROpel), offset by reduced use in 2nd-line ovarian cancer and pricing.
Calquence sales in Europe increased by 72% (CER: 69%) to $493 million (2022: $286 million; 2021: $111 million) as a result of continued growth supported by expanded access in key markets.
Enhertusales in Europe increased to $60 million (2022: $21 million; 2021: $4 million) as a result of continued growth driven by increasing adoption in HER2-positive and HER2-low metastatic breast cancer.
Zoladex sales in Europe (CER: decrease of 1%) were stable at $133 million (2022: $133 million; 2021: $147 million), indicating a flat performance in Europe.
Faslodex sales in Europe decreased by 49% (CER: 50%) to $28 million (2022: $55 million; 2021: $113 million).
CVRM
CVRM sales in Europe increased by 31% (CER: 29%) to $2,503 million (2022: $1,906 million; 2021: $1,512 million).
Forxiga sales in Europe increased by 45% (CER: 42%) to $1,881 million (2022: $1,297 million; 2021: $810 million, benefitting from the addition of cardiovascular outcomes trial data to the label and growth in HFrEF, CKD and the HFpEF approval in February 2023 and updated ESC guidelines in August 2023 also include treatment of patients with HFpEF.
Brilique sales in Europe decreased by 4% (CER: 5%) to $271 million (2022: $282 million; 2021: $346 million) due to clawbacks.
Lokelma sales in Europe increased by 94% (CER: 91%) to $58 million (2022: $30 million; 2021: $13 million) as a result of strong demand growth.
Andexxasales in the Europe increased by 50% (CER: 47%) to $62 million (2022: $41 million; 2021: $18 million)
Crestor sales in Europe increased by 26% (CER: 25%) to $52 million (2022: $41 million; 2021: $52 million).
Seloken /Toprol -XL sales in Europe decreased by 18% (CER: 17%) to $11 million (2022: $14 million; 2021: $11 million).
Onglyza sales in Europe decreased by 16% (CER: 17%) to $32 million (2022: $38 million; 2021: $61 million) due to continued decline for DPP-IV class.
Bydureon sales in Europe decreased by 24% (CER: 26%) to $27 million (2022: $35 million; 2021: $55 million) due to competitive pressures.
Respiratory & Immunology sales in Europe increased by 10% (CER: 8%) to $1,164 million (2022: $1,054 million; 2021: $1,247 million).
Symbicort sales in Europe decreased by 6% (CER: 7%) to $549 million (2022: $582 million; 2021: $670 million), due to continued price and volume erosion from generics and a slowing overall market.
Fasenra sales in Europe increased by 16% (CER: 14%) to $355 million (2022: $305 million; 2021: $286 million), benefiting from expanded leadership in severe eosinophilic asthma.
Trixeo sales in Europe increased to $81 million (2022: $33 million; 2021: $7 million) as a result of sustained growth across markets as new launches continue to progress.
Saphnelo sales in Europe increased to $8 million (2022: $2 million; 2021: $nil) as a result of additional growth driven by ongoing launches in Europe.
Tezspire sales in Europe increased to $48 million (2022: $2 million; 2021: $nil) as a result of achieving and maintaining new-to-brand leadership in key markets as well as pre-filled pen approved in January 2023.
Pulmicort sales in Europe declined by 1% (CER: 2%) to $68 million (2022: $69 million; 2021: $73 million).
Bevespisales in Europe increased by 65% (CER: 62%) to $17 million (2022: $10 million; 2021: $11 million).
Daliresp/Daxas sales in Europe decreased by 9% (CER: 11%) to $8 million (2022: $9 million; 2021: $15 million).
Vaccines & Immune Therapies sales in Europe decreased by 61% (CER: 62%) to $396 million (2022: $1,027 million; 2021: $1,526 million).
COVID-19 mAbs sales in Europe decreased by 96% (CER: 96%) to $12 million (2022: $298 million; 2021: $66 million) and all sales were derived from sales ofEvusheld.
Vaxzevria sales in Europe (CER: decrease of 99%) were $2 million (2022: $365 million; 2021: $1,035 million) due to the fulfilment of contracts signed during the COVID-19 pandemic period.
Beyfortussales in Europe were $19 million (2022: $nil; 2021: $nil).
Synagissales in Europe decreased by 18% (CER: 18%) to $175 million (2022: $213 million; 2021: $203 million).
FluMistsales in Europe increased by 25% (CER: 17%) to $188 million (2022: $151 million; 2021: $222 million).
Rare Disease sales in Europe increased by 7% (CER: 5%) to $1,529 million (2022: $1,428 million; 2021: $667 million).
Soliris sales in Europe decreased by 17% (CER: 18%) to $670 million (2022: $805 million; 2021: $439 million), due to successful conversion fromSoliris toUltomiris, as well as biosimilar erosion in PNH.
Ultomiris sales in Europe increased by 39% (CER: 36%) to $668 million (2022: $481 million; 2021: $169 million), as result of strong demand generation following launches in new markets, particularly in neurology indications, as well as accelerated conversion fromSoliris in key markets, partially offset by price reductions to secure reimbursement for new indications.
Strensiqsales in Europe increased by 14% (CER: 11%) to $89 million (2022: $78 million; 2021: $36 million), as a result of strong patient demand.
Koselugosales in Europe were $53 million (2022: $20 million; 2021: $3 million), driven by patient demand and expansion in new markets.
Kanumasales in Europe increased by 12% (CER: 10%) to $49 million (2022: $44 million; 2021: $20 million), as a result of continued demand growth.
Other
Other medicines sales in Europe decreased by 14% (CER: 15%) to $105 million (2022: $123 million; 2021: $171 million) due to continued impact of generic competition.
Nexium sales in Europe increased by 16% (CER: 13%) to $53 million (2022: $46 million; 2021: $62 million).
Established ROW
Product Sales in the Established ROW region decreased by 14% (CER: 8%) to $5,048 million (2022: $5,846 million; 2021: $4,776 million).
Oncology sales in the Established ROW region increased by 20% (CER: 29%) to $2,266 million (2022: $1,884 million; 2021: $1,982 million). Oncology sales in Japan increased by 20% (CER: 30%) to $1,804 million in the year (2022: $1,501 million; 2021: $1,665 million).
Tagrisso sales in the Established ROW region decreased by 8% (CER: 1%) to $782 million (2022: $847 million; 2021: $913 million) due to increased demand in adjuvant and 1st-line offset by continued impact from HSR price reduction in Japan effective June 2023 and reclassification of Australian government rebates from the fourth quarter of 2023. In Japan, sales ofTagrisso declined by 8% (stable at CER) to $639 million in the year (2022: $695 million; 2021: $775 million).
Imfinzi sales in the Established ROW region increased to $802 million (2022: $401 million; 2021: $405 million) as a result of growth driven by launch of BTC, HCC and Stage IV NSCLC in Japan. In Japan, sales ofImfinzi increased to $714 million (2022: $329 million; 2021: $345 million).
Lynparza sales in the Established ROW region increased by 5% (CER: 12%) to $281 million (2022: $269 million; 2021: $259 million) as a result of growth driven by increased uptake in testing and use in 1 st-line HRD-positive ovarian cancer, partially offset by market expansion re-pricing in Japan from November 2023.Lynparza sales in Japan amounted to $210 million (2022: $203 million; 2021: $199 million), representing a growth of 3% (CER: 12%).
Calquence sales in the Established ROW region increased by 58% (CER: 65%) to $108 million (2022: $69 million; 2021: $18 million).Calquence sales in Japan amounted to $20 million (2022: $7 million; 2021: $3 million).
Enhertu sales in the Established ROW region increased to $32 million (2022: $7 million; 2021: $1 million).
Zoladex sales in the Established ROW region decreased by 4% (CER: increase of 2%) to $118 million (2022: $122 million; 2021: $169 million) due to a drop in sales in Japan. In Japan,Zoladexsales decreased by 22% (CER: 16%) to $83 million (2022: $107 million, 2021: $139 million).
Faslodex sales in the Established ROW region decreased by 7% (CER: increase of 1%) to $96 million (2022: $103 million; 2021: $121 million). In Japan, sales decreased by 6% (CER: increase of 2%) to $95 million (2022: $101 million; 2021: $118 million).
CVRM
CVRM sales in the Established ROW region increased by 9% (CER: 16%) to $744 million (2022: $684 million; 2021: $622 million).
Forxiga sales in the Established ROW region increased by 21% (CER: 30%) to $420 million (2022: $348 million; 2021: $263 million) as a result of continued volume growth driven by HF and CKD launches and generics launched in Canada in the third quarter of 2023. Japan sales grew by 38% (CER: 50%) to $298 million (2022: $215 million; 2021: $150 million).
Brilinta sales in the Established ROW region decreased by 49% (CER: 47%) to $24 million (2022: $46 million; 2021: $63 million) due to generic entry in Canada.
Lokelma sales in the Established ROW region increased by 32% (CER: 42%) to $90 million (2022: $69 million; 2021: $44 million) driven by strong demand growth. Sales in Japan increased by 32% (CER: 42%) to $88 million in the year (2022: $67 million; 2021: $43 million).
Andexxa sales in the Established ROW region increased by 39% (CER: 50%) to $45 million (2022: $32 million; 2021: $nil). Sales in Japan increased by 35% (CER: 46%) to $44 million in the year (2022: $33 million; 2021: $nil).
Crestor sales in the Established ROW region decreased by 7% (stable at CER) to $138 million (2022: $148 million; 2021: $189 million) with a decline in Japan sales by 8% (stable at CER) to $105 million (2022: $114 million; 2021: $151 million), where AstraZeneca collaborates with Shionogi.
*Seloken/Toprol-*XL sales in the Established ROW region showed a decrease by 23% (19% at CER) to $7 million (2022: $9 million; 2021: $11 million).
Onglyza sales in the Established ROW region declined by 30% (CER: 28%) to $15 million (2022: $22 million; 2021: $32 million).
Bydureon sales in the Established ROW region was $nil (2022: $nil; 2021: $6 million).
Respiratory & Immunology sales in the Established ROW region increased by 2% (CER: 8%) to $625 million (2022: $613 million; 2021: $634 million). Respiratory & Immunology sales in Japan increased by 8% (CER: 17%) to $241 million (2022: $222 million; 2021: $284 million) in the year.
Symbicort sales in the Established ROW region decreased by 11% (CER: 7%) to $334 million (2022: $375 million; 2021: $384 million). Sales in Japan declined by 20% (CER: 13%) to $65 million (2022: $81 million; 2021: $124 million) in the year due to generic erosion.
Fasenra sales in the Established ROW region (CER: increase of 6%) were stable at $142 million (2022: $142 million; 2021: $162 million). Sales in Japan declined by 7% (CER: increase if 1%) to $82 million (2022: $88 million; 2021: $110 million) in the year.
Breztri sales in the Established ROW region increased by 55% (CER: 66%) $52 million (2022: $34 million; 2021: $26 million) which is largely contributed by increased market share gains within COPD in Japan and strong launch performance in Canada. Sales in Japan increased by 22% (CER: 31%) to $37 million (2022: $31 million; 2021: $25 million).
Saphnelo sales in the Established ROW region increased to $10 million (2022: $3 million; 2021: $nil) which is largely contributed by additional growth from ongoing launches in Japan. Sales in Japan increased to $9 million (2022: $3 million; 2021: $nil).
Tezspire sales in the Established ROW region increased to $37 million (2022: $2 million; 2021: $nil) driven by Japan maintaining new-to-brand leadership. Sales in Japan increased to $30 million (2022: $2 million; 2021: $nil).
Pulmicort sales in the Established ROW region decreased by 15% (CER: 10%) to $42 million (2022: $49 million; 2021: $47 million). In Japan, sales decreased by 1% (CER: increase of 7%) in the year to $16 million (2022: $17 million, 2021: $23 million).
Vaccines & Immune Therapies sales in the Established ROW region decreased by 76% (CER: 74%) to $295 million (2022: $1,225 million; 2021: $730 million). Vaccines & Immune Therapies sales in Japan decreased by 69% (CER: 66%) to $234 million (2022: $756 million; 2021: $454 million) in the year.
COVID-19 mAbs sales in the Established ROW region declined by 72% (CER: 68%) to $114 million (2022: $407 million; 2021: $nil), with all product sales derived from sales ofEvusheld. Sales in Japan were at $84 million (2022: $215 million; 2021: $nil).
Vaxzevria sales in the Established ROW region declined to $nil (2022: $625 million; 2021: $578 million) due to the fulfilment of contracts signed during the COVID-19 pandemic period. Sales in Japan declined to $nil (2022: $379 million; 2021: $323 million).
Synagis sales in the Established ROW region declined by 7% (CER:1%) to $177 million (2022: $191 million; 2021: $149 million). Sales in Japan declined by 7% (CER: 1%) to $150 million (2022: $162 million; 2021: $132 million).
Rare Disease sales in the Established ROW region increased by 5% (CER: 12%) to $911 million (2022: $870 million; 2021: $364 million). Rare Disease sales in Japan increased by 17% (CER: 26%) to $675 million (2022: $578 million; 2021: $274 million).
Soliris sales in the Established ROW region decreased by 33% (CER: 29%) to $317 million (2022: $476 million; 2021: $197 million) driven by successful conversion fromSoliris toUltomiris.Soliris sales in Japan decreased by 41% (CER: 35%) to $133 million (2022: $224 million; 2021: $111 million).
Ultomiris sales in the Established ROW region increased by 54% (CER: 65%) to $476 million (2022: $310 million; 2021: $129 million), driven by continued conversion fromSoliris and strong demand following new launches. Sales in Japan increased by 55% (CER: 67%) to $441 million (2022: $285 million; 2021: $130 million).
Strensiqsales in the Established ROW region increased by 13% (CER: 22%) to $86 million (2022: $76 million; 2021: $35 million) driven by strong patient demand. Sales in Japan increased to $74 million (2022: $66 million; 2021: $31 million).
Koselugosales in the Established ROW region increased to $24 million (2022: $nil; 2021: $nil) driven by patient demand and expansion in new markets. Sales in Japan increased to $23 million (2022: $nil; 2021: $nil).
Kanumasales in the Established ROW region increased by 2% (CER: 9%) to $8 million (2022: $8 million; 2021: $3 million) driven by continued demand growth. Sales in Japan increased by 28% (CER: 39%) to $4 million (2022: $3 million; 2021: $2 million).
Other
Other medicines sales in the Established ROW region decreased by 64% (CER: 61%) to $207 million (2022: $570 million; 2021: $445 million). Sales in Japan decreased by 69% (CER: 67%) to $156 million (2022: $507 million; 2021: $376 million).
Nexium sales in the Established ROW region decreased by 64% (CER: 61%) to $199 million (2022: $551 million; 2021: $431 million) due to generic launches in Japan in the latter part of 2022. Sales in Japan decreased by 70% (67% at CER) to $150 million (2022: $497 million; 2021: $369 million), where AstraZeneca collaborated with Daiichi Sankyo until September 2021.
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-US 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-US Group companies that is neither a US person nor a foreign subsidiary of a US 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 US 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 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.
Throughout 2017 to 2023, AstraZeneca, through a distributor, sponsored health care provider education programs in Iran, including for employees of hospitals owned or controlled by the Iranian Ministry of Health.
For the year ended December 31, 2023, the Company’s gross revenues and net profits attributable to the above-mentioned Iranian activities were $24 million and $8 million respectively. For the same period, AstraZeneca’s gross revenues and net profits were $45.8 billion and $6.0 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 0.13% 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 227, “—Branches and countries in which the Group conducts business” on page 227, and “Financial Statements—Group Subsidiaries and Holdings” on pages 211 to 215, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 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—2023 compared with 2022”. The information (including tabular data) set forth under the headings “Strategic Report—Business Review—Science and Innovation—Research and Development” on pages 34 to 35, “Strategic Report—Business Review—Growth in Therapy Area Leadership—Operations” on page 40, “Strategic Report—Business Review—Growth in Therapy Area Leadership—IT and IS resources” on page 41, “Financial Statements—Notes to the Group Financial Statements—Note 7—Property, plant and equipment” on pages 169 to 170, “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments, contingent liabilities and contingent assets—Environmental costs and liabilities” on page 204, and “Financial Statements—Notes to the Group Financial Statements—Note 8—Leases” on pages 170 to 171, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 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 pages 169 to 170 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024.
ITEM 4A. UNRESOLVED STAFF COMMENTS
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, “Financial Statements— Notes to the Group Financial Statements—Note 1—Revenue—Product Sales” on page 160, “Financial Statements—Notes to the Group Financial Statements—Note 28—Financial risk management objectives and policies” on pages 195 to 201, and “Additional Information—Important information for readers of this Annual Report” on page 236, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference. The information contained herein under Item 8—“Summarized financial information for guarantee of securities of subsidiaries” is incorporated by reference. Please also see the information above under the heading Item 4—“Information on the Company— Business Overview—Geographical Review”.
A. Operating Results
2023 compared with 2022
The information set forth under the heading “Strategic Report—Financial Review” on pages 58 to 74 (excluding the information set forth under the subheadings “Full year 2024: additional commentary” and “Currency impact” on page 71) of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated herein by reference.
2022 compared with 2021
The information set forth under the heading “Strategic Report—Financial Review” on pages 60 to 76 of AstraZeneca’s “Annual Report and Form 20-F Information 2022” included as exhibit 15.1 to the Form 20-F dated February 21, 2023 is incorporated herein by reference.
B. Liquidity and capital resources
The information (including graphs and tabular data) set forth under the headings “Strategic Report—Financial Review—Cash flow and liquidity—for the year ended 31 December 2023” and “—Summary cash flows” on page 68, “Strategic Report—Financial Review—Financial position – 31 December 2023” on pages 69 to 70, “Strategic Report—Financial Review—Capitalisation and shareholder return” on page 71, “Financial Statements—Notes to the Group Financial Statements—Note 19—Interest-bearing loans and borrowings” on pages 179 to 181, “Financial Statements—Notes to the Group Financial Statements—Note 13—Derivative financial instruments” on page 177, “Financial Statements—Notes to the Group Financial Statements—Note 23—Reserves” on page 191, “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments, contingent liabilities and contingent assets” on pages 204 to 210, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
We consider the Group’s working capital to be sufficient for its present requirements.
C. Research and development and Patent Protection and Licenses
The information (including graphs and tabular data) set forth under the headings “Strategic Report—Business Review—Science and Innovation—Research and Development” on pages 34 to 35, “Strategic Report—Business Review—Science and Innovation—Development pipeline overview” on page 37, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference. Please also see the information above under the headings Item 4—“Information on the Company— Business Overview—Development Pipeline as of February 8, 2024” and “—Patent Expiries of Key Marketed Products”.
D. Trend information
The information set forth in the introductory paragraph under the heading “Strategic Report—Financial Review” on page 58 and 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—Financial Review—Measuring performance” on pages 60 to 62, “Financial Statements— Notes to the Group Financial Statements—Note 1—Revenue—Product Sales” on page 160, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
E. Critical Accounting Estimates
The information (including graphs and tabular data) set forth under the headings “Strategic Report—Financial Review—Critical accounting policies and estimates” on page 72, “Financial Statements—Group Accounting Policies” on page 152 to 159 and “Financial Statements— Notes to the Group Financial Statements—Note 30—Commitments, contingent liabilities and contingent assets” on pages 204 to 210, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A. Directors and Senior Management
The information (including tabular data) set forth under the headings “Corporate Governance—Board of Directors as at 31 December 2023” on pages 78 to 79, and “Corporate Governance—Annual Report on Remuneration—Governance—Directors’ service contracts and letters of appointment” on page 126, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
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 2023” on page 80 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
Senior Executive Team (SET) Biographies as at December 31, 2023
Sharon Barr – Executive Vice-President, Biopharmaceuticals R&D
Sharon was appointed as Executive Vice-President, BioPharmaceuticals R&D in August 2023. She is responsible for discovery through to late-stage development across CVRM and Respiratory & Immunology. Prior to this role, Sharon served as Senior Vice President, Head of Research and Product Development of Alexion, AstraZeneca Rare Disease having joined in 2013. With more than 18 years of industry experience she has previously led translational research, precision medicines, and global drug development teams. Sharon received her PhD in molecular biology from New York University, and completed a postdoctoral fellowship focused on mechanisms of DNA Damage and Repair at Stanford University. In 2022, Sharon was recognised as a Healthcare Businesswoman’s Association Luminary in recognition of her transformational leadership and passion for mentoring those around her.
Pam Cheng – Executive Vice-President, Global Operations, IT & Chief Sustainability Officer
Pam was appointed Executive Vice-President, Operations & Information Technology in June 2015 and assumed additional responsibility for the AstraZeneca Sustainability strategy and function in January 2023. Pam joined AstraZeneca after having spent 18 years with Merck/MSD in Global Manufacturing and Supply Chain and Commercial roles. Pam 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, responsible for MSD’s entire business in China. Prior to joining Merck, Pam held various engineering and project management positions at Universal Oil Products, Union Carbide Corporation and GAF Chemicals. Pam holds Bachelor’s and Master’s degrees in chemical engineering from Stevens Institute of Technology in New Jersey and an MBA in marketing from Pace University in New York. In addition to her role at AstraZeneca, Pam serves as a Non-Executive Director of the Smiths Group plc Board and as a Trustee Member of the Board for Stevens Institute of Technology. Pam also serves as an Advisor to the International Society of Pharmaceutical Engineering (ISPE) Board of Directors.
Ruud Dobber – Executive Vice-President, BioPharmaceuticals Business Unit
Ruud was appointed Executive Vice-President, BioPharmaceuticals Business Unit in January 2019 and is responsible for product strategy and commercial delivery for CVRM, Respiratory and Immunology, and Vaccines & Immune Therapies. Prior to this, Ruud held the role of Executive Vice-President, North America and was responsible for driving growth and maximising the contribution of the commercial operations in North America. Ruud joined Astra (later to become AstraZeneca) in 1997 and has 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. Ruud holds a doctorate in immunology from the University of Leiden, Netherlands, beginning his career as a research scientist in immunology and ageing.
Ruud was appointed as a non-executive director of the Board of Almirall S.A. in June 2021.
Marc Dunoyer – Chief Executive Officer, Alexion and Chief Strategy Officer, AstraZeneca
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.
Marc is a member of the Boards of Orchard Therapeutics Plc and JCR Pharmaceuticals.
David Fredrickson – Executive Vice-President, Oncology Business Unit
Dave was appointed Executive Vice-President, Oncology Business Unit in October 2017 and 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. While in Japan, Dave also served as Vice Chairman of the European Federation of Pharmaceutical Industries and Associations Japan and was a Director of the Japan Pharmaceutical Manufacturers Association. 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. Prior to this, Dave worked at the Monitor Group, LLC (now Monitor Deloitte Group, LLC), a global strategy consultancy. Dave is a graduate of Georgetown University in Washington DC.
Susan Galbraith - Executive Vice-President, Oncology R&D
Susan was appointed as Executive Vice-President, Oncology R&D in July 2021. In this role, Susan has global accountability for Oncology R&D from discovery through to late-stage development. Since joining AstraZeneca in 2010, Susan has been instrumental in bringing seven new medicines to patients, four of which are now blockbusters. Prior to AstraZeneca, Susan held senior Oncology R&D roles at Bristol-Myers Squibb. A Clinical Oncologist by background, Susan trained in medicine at Manchester and Cambridge Universities and has a PhD from the University of London. She holds an honorary Doctorate of Medical Science from the Institute of Cancer Research and is a Fellow of the Academy of Medical Sciences. Susan serves on the American Association for Cancer Research Board of Directors, the Institute of Cancer Research Scientific Advisory Board and the European Association of Cancer Research Advisory Council.
Menelas (Mene) Pangalos – Executive Vice-President, BioPharmaceuticals R&D (retiring, announced 28 July 2023)
Mene was appointed as Executive Vice-President, BioPharmaceuticals R&D in January 2019. Mene is responsible for 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 fivefold improvement in productivity. Prior to joining AstraZeneca, Mene held senior R&D roles at Pfizer, Wyeth and GSK. Mene holds Honorary Doctorates from Glasgow University and Imperial College, London, is a Fellow of the Royal Society, the Academy of Medical Sciences, the Royal Society of Biology and Clare Hall, University of Cambridge. He is a Visiting Professor at The Wolfson Centre at Kings College and an Honorary Professor at the University of Cambridge. He is also on the Boards of The Francis Crick Institute and The Judge Business School, Cambridge University In 2019, Mene was awarded a knighthood from The Queen and has won a variety of awards including the Prix Galien Medal, Greece. He has overseen the creation of AstraZeneca’s new Global R&D Centre in Cambridge and the company’s COVID-19 efforts.
Jeff Pott – Chief Human Resources Officer, Chief Compliance Officer and General Counsel
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 and was appointed Chief Compliance Officer in January 2023. 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.
Iskra Reic – Executive Vice-President, Vaccines and 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, medical affairs and commercial operations. Iskra leads the development of the unit’s portfolio and product strategy as well as establishing AstraZeneca as a trusted partner to the Infectious Disease community, supporting our ambition to develop transformative vaccines and antibodies against critical infectious diseases.
Having trained as a Doctor of Dental Surgery at the Medical University of Zagreb, Croatia, Iskra joined AstraZeneca in 2001. During this time, Iskra 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. 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.
Leon Wang – Executive Vice-President, International and China President
Leon Wang is Executive Vice-President, International and President, China. He 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. In January 2017, Leon was promoted to Executive Vice-President, Asia Pacific Region. 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.
B. Compensation
The information (including graphs and tabular data) set forth under the headings “Corporate Governance—Directors’ Remuneration Report” on pages 102 to 105, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Remuneration” on page 83, “Strategic Report—Our Strategy and Key Performance Indicators—Our Key Performance Indicators and remuneration” on page 12, “Corporate Governance—Remuneration at a glance” on page 106, “Corporate Governance—How our performance measures for 2024 support the delivery of our strategy” on page 107, “Corporate Governance—How the Remuneration Committee ensures targets are stretching” on page 108, “Corporate Governance—Annual Report on Remuneration” on pages 109 to 126, “Corporate Governance—Remuneration Policy” on pages 127 to 138, “Financial Statements—Notes to the Group Financial Statements—Note 22—Post-retirement pension and other defined benefit schemes” on pages 183 to 191, “Financial Statements—Notes to the Group Financial Statements—Note 29—Employee costs and share plans for employees” on pages 201 to 203 and “Financial Statements—Notes to the Group Financial Statements—Note 31—Statutory and other information—Key management personnel compensation”, on page 210, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 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 77, “Corporate Governance—Board of Directors as at 31 December 2023” on pages 78 to 79, “Corporate Governance—Senior Executive Team (SET) as at 31 December 2023” on page 80, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Board Leadership and Company Purpose” on page 81, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Division of responsibilities” on page 81, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Remuneration” on page 83, “Corporate Governance—Science Committee Report” on page 92, “Corporate Governance—Nomination and Governance Committee Report” on pages 90 to 91, “Corporate Governance—Sustainability Committee Report” on page 93, “Corporate Governance— Compliance with the UK Corporate Governance Code—Risk management and controls—Global Compliance and Group Internal Audit (GIA)” on page 83, “Corporate Governance—Annual Report on Remuneration—Governance—Directors’ service contracts and letters of appointment” on page 126, “Corporate Governance—Remuneration at a glance—Looking ahead—Executive Directors’ remuneration for 2024” on page 106, “Corporate Governance—Annual Report on Remuneration—Executive Directors’ remuneration” on pages 109 to 117, “Corporate Governance—Annual Report on Remuneration—Non-Executive Directors’ remuneration” on page 118 and “Corporate Governance—Audit Committee Report” on pages 94 to 101, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
Please also see the information above under the heading Item 6—Directors and Senior Management—Senior Executive Team (SET) Biographies”.
D. Employees
The information set forth under the headings , “Strategic Report—Business Review—Science and Innovation—Research and Development” on pages 34 to 35, “Strategic Report—Business Review—Growth and Therapy Area Leadership—Sales and marketing—Responsible sales and marketing” on page 39, “Strategic Report—Business Review—Growth and Therapy Area Leadership—Operations” on page 40, “Strategic Report—Business Review—Growth and Therapy Area Leadership—IT and IS resources” on page 41, “Strategic Report—Business Review—Growth and Therapy Area Leadership—Business Development” on page 42, “Strategic Report—Business Review—People and Sustainability” on pages 43 to 49 and “Financial Statements—Notes to the Group Financial Statements—Note 29—Employee costs and share plans for employees” (including the tabular data) on pages 201 to 203, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 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 201 to 203, “Corporate Governance—Annual Report on Remuneration—Directors’ shareholdings” on pages 119 to 120, and “Additional Information—Directors’ Report—Directors’, officers’ and SET shareholdings” and “—Options to purchase securities from registrant or subsidiaries” on page 228, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
F. Disclosure of a registrant’s action to recover erroneously awarded compensation
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A. Major Shareholders
The information set forth under the heading “Additional Information—Shareholder information—US holdings” on page 226 and “Additional Information—Directors’ Report—Major shareholdings” (including tabular data) on page 228 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 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 210, “Additional Information—Shareholder information—Related party transactions” on page 225, “Additional Information—Shareholder information—Issued share capital, shareholdings and share prices” on page 226 and “Additional Information—Directors’ Report—Major shareholdings” on page 228, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
C. Interests of Experts and Counsel
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 225 to 226, “Strategic Report —Financial Review—Dividend and share repurchases” on page 71 and “Additional Information—Directors’ Report—Distributions to shareholders-dividends for 2023” on page 228, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
Summarized financial information for guarantee of securities of subsidiaries
AstraZeneca Finance LLC (“AstraZeneca Finance”) is the issuer of 0.700% Notes due 2024, 1.200% Notes due 2026, 1.750% Notes due 2028, 4.875% Notes due 2028, 4.900% Notes due 2030, 2.250% Notes due 2031 and 4.875% Notes due 2033 (the “AstraZeneca Finance Notes”). Each series of AstraZeneca Finance Notes has been fully and unconditionally guaranteed by AstraZeneca PLC. AstraZeneca Finance is 100% owned by AstraZeneca PLC and each of the guarantees by AstraZeneca PLC is full and unconditional and joint and several.
The AstraZeneca Finance Notes are senior unsecured obligations of AstraZeneca Finance and rank equally with all of AstraZeneca Finance’s existing and future senior unsecured and unsubordinated indebtedness. The guarantee by AstraZeneca PLC of the AstraZeneca Finance Notes is the senior unsecured obligation of AstraZeneca PLC and ranks equally with all of AstraZeneca PLC’s existing and future senior unsecured and unsubordinated indebtedness. Each guarantee by AstraZeneca PLC is effectively subordinated to any secured indebtedness of AstraZeneca PLC to the extent of the value of the assets securing such indebtedness. The AstraZeneca Finance Notes are structurally subordinated to indebtedness and other liabilities of the subsidiaries of AstraZeneca PLC, none of which guarantee the AstraZeneca Finance Notes.
AstraZeneca PLC manages substantially all of its operations through divisions, branches and/or investments in subsidiaries and affiliates. Accordingly, the ability of AstraZeneca PLC to service its debt and guarantee obligations is also dependent upon the earnings of its subsidiaries, affiliates, branches and divisions, whether by dividends, distributions, loans or otherwise.
Pursuant to Rule 13-01 and Rule 3-10 of Regulation S-X of the Securities Act, we present below the summary financial information for AstraZeneca PLC, as Guarantor, excluding its consolidated subsidiaries, and AstraZeneca Finance, as the issuer, excluding its consolidated subsidiaries. The following summary financial information of AstraZeneca PLC and AstraZeneca Finance is presented on a combined basis and transactions between the combining entities have been eliminated. Financial information for non-guarantor entities has been excluded. Intercompany balances and transactions between the obligor group and the non-obligor subsidiaries are presented on separate lines.
Obligor group summarised Statement of Comprehensive Income
| · · · · | ||
|---|---|---|
| | FY 2023 | FY 2022 |
| · · $m · · $m | ||
| Total Revenue | — | — |
| Gross profit | — | — |
| Operating loss | (34) | (27) |
| Loss for the period | (976) | (687) |
| Transactions with subsidiaries that are not issuers or guarantors | 15,660 | 1,071 |
Obligor group summarised Statement of Financial Position information
| · · · · | ||
|---|---|---|
| | At 31 Dec 2023 | At 31 Dec 2022 |
| · · $m · · $m | ||
| Current assets | 5 | 4 |
| Non-current assets | — | — |
| Current liabilities | (4,856) | (2,839) |
| Non-current liabilities | (22,239) | (22,797) |
| Amounts due from subsidiaries that are not issuers or guarantors | 18,421 | 7,806 |
| Amounts due to subsidiaries that are not issuers or guarantors | — | (293) |
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, contingent liabilities and contingent assets” on pages 204 to 210 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 and is incorporated by reference.
The proceedings discussed below are provided to supplement and update the corresponding disclosure in AstraZeneca’s “Annual Report and Form 20-F Information 2023”. Unless noted below or in AstraZeneca’s “Annual Report and Form 20-F Information 2023”, no provisions have been established in respect of these proceedings.
UK proceedings
PARP Inhibitor Royalty Dispute
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 GSK in the Commercial Court of England and Wales alleging that GSK has failed to pay all of the royalties due on niraparib sales under the license agreements. The case was transferred to the Chancery Division and a trial took place in March 2023. In April 2023, the trial court issued a decision in AstraZeneca’s favour. GSK was granted permission to appeal, and the appellate hearing was held in January 2024. In February 2024, the Court of Appeal issued a decision in GSK’s favour. AstraZeneca is considering its options.
US Proceedings
Onglyza and Kombiglyze
In the US, AstraZeneca has been defending various lawsuits alleging heart failure, cardiac injuries, and/or death from treatment withOnglyza orKombiglyze. In the California state court proceeding, the trial court granted summary judgment for AstraZeneca, which the California appellate court affirmed. The California Supreme Court has declined further review, so the California state court proceeding has concluded. In 2022, the US District Court for the Eastern District of Kentucky, presiding over the consolidated federal cases, granted AstraZeneca’s motion for summary judgment. In February 2024, the US Court of Appeals for the Sixth Circuit affirmed the grant of summary judgment in the consolidated federal cases.
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 210 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 and is incorporated by reference.
The discussion below is provided to supplement and update the corresponding disclosure in AstraZeneca’s “Annual Report and Form 20-F Information 2023”.
Icosavax acquisition
In December 2023, AstraZeneca entered into a definitive agreement to acquire Icosavax, Inc. The acquisition strengthens AstraZeneca’s late-stage pipeline with Icosavax’s lead investigational vaccine candidate, IVX-A12, a potential first-in-class, Phase III-ready, combination VLP vaccine that targets both RSV and human metapneumovirus (hMPV). RSV and hMPV are both leading causes of severe respiratory infection and hospitalisation in adults 60 years of age and older and those with chronic conditions such as cardiovascular, renal and respiratory disease. Subject to the satisfaction of the conditions in the merger agreement, the acquisition closed on February 19, 2024.
Other than as disclosed in this Item, since the date of the annual consolidated financial statements included in this Form 20-F dated February 20, 2024, no significant change has occurred.
ITEM 9. THE OFFER AND LISTING
A. Offer and Listing Details
The information (including tabular data) set forth under the heading “Additional Information—Shareholder information” on pages 225 to 226 and “Additional Information—Shareholder information—Ordinary Shares in issue” on page 226 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 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
C. Markets
The information set forth in the introductory paragraph under the heading “Additional Information— Shareholder information” on page 225 and “Additional Information—Shareholder information—Issued share capital, shareholdings and share prices” on page 226 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
D. Selling Shareholders
E. Dilution
F. Expenses of the Issue
ITEM 10. ADDITIONAL INFORMATION
A. Share Capital
B. Memorandum and Articles of Association
The information set forth under the heading “Additional Information—Directors’ Report—Articles of Association” on page 228 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference. Please also see the information above in the first paragraph under the heading Item 4—“Information on the Company—History and Development of the Company”.
C. Material Contracts
D. Exchange Controls
The information set forth under the headings “Additional Information—Shareholder information—Exchange controls and other limitations affecting security holders” on page 226 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
E. Taxation
Taxation for US persons
The following statements are intended only as a general guide to certain 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, the current US/UK double taxation convention and what is understood to be the current practice of HMRC and the US Internal Revenue Service as at the date of this Form 20-F dated February 20, 2024, each of which may change, possibly with retroactive effect. 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 Company is not required to withhold UK tax when paying a dividend. Liability to tax on receipt of dividends will depend upon the individual circumstances of a US holder. A US holder that is resident outside the UK for UK tax purposes will not generally be subject to UK tax on dividend income received, 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.
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
US holders that are individuals or companies who are not resident in the UK for tax purposes are generally not 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. US holders should consult their own tax advisers about the treatment of capital gains in the UK.
For US federal income tax purposes, a US holder will generally recognise US source capital gain or loss 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 2023. 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 taxes on estates of deceased persons and on gifts (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
Under current UK law 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. Under these rules, the rate of UK stamp duty or SDRT is 1.5% applied, in each case, to the issue price when the Ordinary Shares are issued, the amount or value of the consideration or, in some circumstances, the value of the Ordinary Shares. Following certain EU litigation, HMRC accepted that they would no longer seek to apply the 1.5% charge to the issue (or, where it is integral to the raising of new capital, the transfer) of shares (such as the Ordinary Shares) into a depositary receipt system (such as the ADR arrangement). UK legislation enacted on 29 June 2023, in the form of the Retained EU Law (Revocation and Reform) Act 2023, created some uncertainty as to the status of the 1.5% charge from 1 January 2024. The Finance Bill 2023-4, which is expected to be enacted in early 2024, makes provision to ensure it continues to be the case, notwithstanding the effect of the Retained EU Law (Revocation and Reform) Act 2023, that UK stamp duty or SDRT of 1.5% is not payable in relation to issues of securities into depositary receipt systems, and transfers of securities into a depositary receipt system, where such transfer is integral to the raising of new capital by the company concerned. These measures will have provisional effect from 1 January 2024. The Finance Bill 2023-4, if enacted, will give permanent legislative effect to the proposed measures, which will otherwise cease to have effect. Therefore, there is some remaining uncertainty as to the status of the 1.5% charge in the period between 1 January 2024 and enactment of the Finance Bill 2023-4.
Transfers of Ordinary Shares into CREST will generally not be subject to UK stamp duty or SDRT, unless such a transfer is made (or deemed to be made) for a consideration in money or money’s worth, in which case a liability to SDRT will arise, usually at the rate of 0.5% of the value of the consideration.
A transfer of, or an unconditional agreement to transfer, Ordinary Shares (whether within or outside CREST) will generally be subject to UK stamp duty and/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). Where both UK stamp duty and SDRT apply, then any SDRT charge may be cancelled if within six years of the date of the agreement becoming unconditional an instrument of transfer is executed pursuant to the agreement, and stamp duty is paid on that instrument. The purchaser would usually pay any UK stamp duty or SDRT that is due. No UK stamp duty will be payable on the transfer of existing ADRs, provided that there is no written instrument of transfer, and no SDRT should be payable on an unconditional agreement to transfer existing ADRs.
F. Dividends and Paying Agents
G. Statement by Experts
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 20, 2024, may be inspected at the Company’s registered office at 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge CB2 0AA, UK.
I. Subsidiary Information
J. Annual Report to Security Holders
The Company intends to submit any annual report provided to security holders in electronic format as an exhibit to a current report on Form 6-K.
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 71 and “Financial Statements—Notes to the Group Financial Statements—Note 28—Financial risk management objectives and policies” on pages 195 to 201, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
A. Debt Securities
B. Warrants and Rights
C. Other Securities
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 US dollars●compliance with exchange control regulations and other regulatory 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) | As incurred by the Depositary. |
| (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, 2023, 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, 2023, we have been paid approximately $17.05 million arising out of fees charged in respect of dividends paid during 2023 and $0.87 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.
PART II
ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
ITEM 15. CONTROLS AND PROCEDURES
A.** **** **Disclosure 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 83, “Corporate Governance—Audit Committee Report—Internal Controls” on page 100, and “Financial Statements—Directors’ Annual Report on Internal Controls over Financial Reporting” on page 140, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 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 US 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 140 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024, which is incorporated by reference.
C. ** **Attestation Report of Independent Registered Public Accounting Firm
The effectiveness of the Company’s internal control over financial reporting as of December 31, 2023, has been audited by PricewaterhouseCoopers LLP, independent registered public accounting firm, as stated in its report dated February 8, 2024, which is included below under the heading Item 18—“Financial Statements—Report of Independent Registered Public Accounting Firm”.
D. ** **Changes in Internal Control over Financial Reporting
Based on the evaluation conducted, management has concluded that no such changes have occurred during the period covered by this Form 20-F that have materially affected, or are 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—Corporate Governance Overview—Board Committee membership and meeting attendance in 2023” on page 77 and “Corporate Governance—Audit Committee Report—Committee overview—Committee composition” on page 95, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
ITEM 16B. CODE OF ETHICS
The information set forth under the headings “Strategic Report—Business Review—People and Sustainability—Code of Ethics” on page 49, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Risk Management and Controls—Global Compliance and Group Internal Audit (GIA)” on page 83, “Business Review—Science and Innovation—Bioethics” on page 36, and “Corporate Governance—Audit Committee Report—Legal and Compliance” on page 96, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 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 (PCAOB ID 876) in 2023 and 2022:
| · · · · | ||
|---|---|---|
| | | Year ended December 31, |
| | 2023 | 2022 |
| | | ($ million) |
| Audit fees | 29.1 | 28.7 |
| Audit-related fees | 0.8 | 0.4 |
| All other fees | 0.2 | 0.2 |
| Total | 30.1 | 29.3 |
Audit fees included $15.0 million for the audit of subsidiaries pursuant to legislation (2022: $15.1 million), $10.2 million for the Group audit (2022: $9.9 million), $0.6 million for assurance services in relation to interim financial statements (2022: $0.6 million) and $3.3 million in respect of section 404 of the Sarbanes-Oxley Act (2022: $3.1 million). $0.7 million of Audit fees payable in 2023 are in respect of the Group audit and audit of subsidiaries related to prior years ($0.6 million of Audit fees payable in 2022 are in respect of the Group audit and audit of subsidiaries related to prior years).
Audit-related fees included $0.5 million of other audit-related services (2022: $0.1 million) and $0.3 million for the audit of subsidiaries’ pension schemes (2022: $0.3 million). Included in Audit-related fees for 2023 are $0.3 million of services provided in relation to the 2023 debt issuance and EMTN programme renewal.
All other fees of $0.2 million relate to other assurance services (2022: $0.2 million).
The information (including tabular data) set forth under the heading “Corporate Governance—Audit Committee Report” on pages 94 to 101 of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
US 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 fees 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 2023 and 2022, the percentage of the total amount of fees 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
ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS
ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT
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 2018 (the “U.K. Code”) in respect of its corporate governance practices. The current edition of the U.K. Code, which came into effect for reporting periods beginning on or after January 1, 2019, was effective to the Company for the year ended December 31, 2023. 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.
A summary of the significant ways in which the Company’s corporate governance practices differ from those followed by US 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 chair of the Company may be a member, but not chair, of the Remuneration Committee, provided he or she was considered independent on appointment as chair. 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 chair of the Company may be a member or chair of the nomination committee, provided he or she was considered independent on appointment as chair. However, the chair 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 December 31, 2023)
| · · | |
|---|---|
| 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 I: Gender Identity · · · · | ||||||||
| Directors | | 6 | | 7 | | - | | - |
| Part II: Demographic Background | ||||||||
| Underrepresented Individual in Home Country Jurisdiction | 2 | |||||||
| LGBTQ+ | - | |||||||
| Did Not Disclose Demographic Background | 1 | |||||||
ITEM 16H. MINE SAFETY DISCLOSURE
ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
ITEM 16J. INSIDER TRADING POLICIES
ITEM 16K. CYBERSECURITY
Risk and Management Strategy
AstraZeneca employs complimentary processes for assessing, identifying, and managing risk from cybersecurity threats. AstraZeneca information systems are protected by a multi-layered set of technology, processes, and cybersecurity experts consistent with the US National Institute of Standards and Technology (NIST) Cybersecurity Framework (CSF). Maturity against the one hundred and eighteen NIST CSF controls is assessed via recurring independent third-party assessments, internal audits, and penetration testing. The outputs of these activities are represented in detailed cybersecurity operations and performance metrics that are reviewed by multiple leadership levels and are summarized in enterprise risk reporting provided to the Senior Executive Committee and Audit Committee. Third-party partners are subject to appropriate NIST CSF controls as specified in AstraZeneca third-party risk management and procurement processes, and enforced via service agreement and contract terms and conditions. AstraZeneca has not experienced any previous cybersecurity incidents that have materially impacted its business or business strategy. Ongoing risks from cybersecurity threats demand management vigilance, investment, and oversight, as further described below.
Governance
Cybersecurity remains a core AstraZeneca enterprise risk focus area. The Board of Directors’ Audit Committee provides oversight of risks from cybersecurity threats. The Senior Executive Team (SET) receives quarterly cybersecurity updates via the enterprise risk function. The quarterly updates are forwarded to the Audit Committee. Audit Committee expertise includes leaders that have management expertise across a broad range of industries and market sectors which includes oversight of cybersecurity risk and incidents. The AstraZeneca cybersecurity risk management program is implemented by the Chief Information Security Officer (CISO), who reports to the Chief Digital Officer/Chief Information Officer (CDIO). The CISO is the primary executive responsible for assessing and managing cybersecurity risks, including delivering recurring updates to CDIO and SET via standardized quarterly reporting. The CISO has over three decades of cumulative cybersecurity expertise gained from increasingly complex roles in Life Sciences, Electronics Manufacturing, Supply Chain, Software Development, and IT Technical Support. The CDIO reviews risk management recommendations from the CISO and tracks AstraZeneca’s global internal audit management plans that include corrective actions to address exposed risk to information systems from cybersecurity threats. AstraZeneca maintains a global cybersecurity defense operations center that relies on advanced technology, skilled cybersecurity operations staff and documented incident response plans that are closely coupled with AstraZeneca’s enterprise crisis management processes. Incident response plans and escalation via decision matrix criteria defined in crisis management procedures ensure management is informed of cybersecurity incident prevention, detection, mitigation, and remediation. The CDIO and CISO report risk information to the Audit Committee via recurring Board of Directors presentations and written reports.
The information set forth under the heading “Strategic Report—Business Review—IT and IS resources” on page 41, “Strategic Report—Risk Overview—Principal Risks—Cybersecurity Risk” on page 54, “Strategic Report—Risk Overview—Supply chain and business execution risks—Failure in information technology or cybersecurity” on page 56, and “Corporate Governance—Audit Committee Report—Cyber risk, digital security and information governance” on page 96, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference. Please also see the information above under the heading Item 3—“Key Information—Risk Factors—Supply chain and business execution risks—Failure in information technology or cybersecurity” above.
PART III
ITEM 17. FINANCIAL STATEMENTS
The Company has responded to Item 18 in lieu of this item.
ITEM 18. FINANCIAL STATEMENTS
The accompanying Consolidated Statements of Comprehensive Income, of Financial Position, of Changes in Equity and of Cash Flows and the Group Accounting Policies and the related notes (including tabular data) set forth under the headings “Financial Statements” on pages 139 to 210 (excluding the information set forth under the subheadings “Independent auditors’ report to the members of AstraZeneca PLC” on pages 141 to 147) and “Financial Statements—Group Financial Record” on page 223, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2023” included as exhibit 15.1 to this Form 20-F dated February 20, 2024 is incorporated by reference.
In accordance with Rule 405(a)(3) under Regulation S-T, this information (including tabular data) is reproduced under Item 8 herein tagged with Inline XBRL formatting.
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 statements of financial position of AstraZeneca PLC and its subsidiaries (the “Group”) as of 31 December 2023, 2022 and 2021, and the related consolidated statements of comprehensive income, of changes in equity and of cash flows for each of the three years in the period ended 31 December 2023, including the Group accounting policies and the related notes to the Group financial statements (collectively referred to as the “consolidated financial statements”). We also have audited the Group’s internal control over financial reporting as of 31 December 2023, based on criteria established inInternal 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 Group as of 31 December 2023, 2022 and 2021, and the results of its operations and its cash flows for each of the three years in the period ended 31 December 2023 in accordance with (i) IFRS Accounting Standards as issued by the International Accounting Standards Board, (ii) UK-adopted International Accounting Standards and (iii) International Accounting Standards as adopted by the European Union. Also in our opinion, the Group maintained, in all material respects, effective internal control over financial reporting as of 31 December 2023, based on criteria established inInternal Control - Integrated Framework (2013) issued by the COSO.
Basis for Opinions
The Group’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 Management’s Annual Report on Internal Control over Financial Reporting appearing under Item 15.B. Our responsibility is to express opinions on the Group’s consolidated financial statements and on the Group’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 Group 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.
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 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 Managed Care, Medicaid and Medicare Part D rebates on US Product Sales (excluding Rare Diseases)
As described in the Group Accounting Policies, and Notes 1 and 20 to the consolidated financial statements, when invoicing Product Sales in the US, management estimates the rebates the Group expects to pay and considers there to be a significant estimate associated with the rebates for Managed Care, Medicaid and Medicare Part D. The major market with rebates and other revenue accruals is the US. The US Rebates, chargebacks, returns and other revenue accruals liability at 31 December 2023 amounted to $5,116 million (including $190 million attributed to Rare Diseases), principally consisting of rebates related to Managed Care, Medicaid and Medicare Part D. 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. 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 and various state programmes. 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 rebate estimates include assumptions in respect of aggregate future sales levels, segment mix and customers’ contractual performance, and in addition for Managed Care, US Medicaid and Medicare Part D, the channel inventory levels, and assumptions related to lag time.
The principal considerations for our determination that performing procedures relating to recognition and measurement of accruals for Managed Care, Medicaid and Medicare Part D rebates on US Product Sales (excluding Rare Diseases) is a critical audit matter are the (i) significant estimation by management in determining the accruals for the Managed Care, Medicaid, and Medicare Part D programmes, which are monitored and adjusted in light of contractual and legal obligations, historical trends, past experience and projected market conditions and (ii) high degree of auditor judgement, subjectivity, and effort in evaluating management’s significant assumptions related to aggregate future sales levels, segment mix and customers’ contractual performance, the channel inventory levels, and lag time. In addition, the audit effort involved the use of professionals with specialised skill and knowledge.
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 recognition and measurement of the Managed Care, Medicaid, and Medicare Part D rebate accruals. These procedures also included, among others, (i) developing an independent estimate of these accruals; (ii) comparing our independent estimate to the accruals recorded by management; (iii) assessing the effect of any adjustments to prior years’ accruals in the current year’s results; and (iv) testing actual payments made and rebate claims processed by the Group, and evaluating those claims for consistency with the contractual and mandated terms of the Group’s arrangements. Developing the independent estimate of the accruals involved assessing the terms of the specific rebate programmes and/or contracts with customers; historical revenue data; market demand and market conditions in the US; third party information on inventory held by direct and indirect customers; and the historical trend of actual rebate claims paid. Professionals with specialised skill and knowledge were used to assist in assessing the compliance of the Group’s Medicaid rebate policies against the regulatory requirements.
Impairment assessment of the product, marketing and distribution rights and other intangibles
As described in the Group Accounting Policies and Note 10 to the consolidated financial statements, the Group has product, marketing and distribution rights totalling $36,941 million and other intangibles totalling $646 million (hereafter the intangible assets) at 31 December 2023. Management performs an impairment trigger assessment for all intangible assets. 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 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. Group level budgets and forecasts include forecast capital investment and operational impacts related to sustainability projects, as well as inflationary impacts, 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. The key assumptions and significant estimates used in calculating the recoverable amounts are highly sensitive. The key assumptions include the outcome of research and development activities, probability of technical and regulatory success, market volume, share and pricing (to derive peak year sales), the amount and timing of projected future cash flows, and sales erosion curves following patent expiry. In 2023, the Group recorded impairment charges of $434 million related to product, marketing and distribution rights.
The principal considerations for our determination that performing procedures relating to the impairment assessment of the product, marketing and distribution rights and other intangibles is a critical audit matter are the significant judgements made by management when determining the recoverable amount of the Group’s individual assets or CGUs. This in turn led to a high degree of auditor judgement, subjectivity, and effort in performing procedures and evaluating assumptions in management’s cash flow projections related to the probability of technical and regulatory success, peak year sales and sales erosion curves following patent expiry. In addition, the audit effort involved the use of professionals with specialised skill and knowledge.
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 intangible asset impairment assessment, controls over the identification of triggering events and the development of assumptions used to estimate the recoverable amounts of the Group’s CGUs. These procedures also included, among others, testing management’s process for identifying indicators for impairment and for determining the recoverable amount of the Group’s individual assets or CGUs. Testing management’s process involved a) evaluating the reasonableness of significant assumptions of i) probability of technical and regulatory success, with the assistance of professionals with specialised skill and knowledge and ii) amount and timing of projected future cash flows (in particular, the drivers of peak year sales and sales erosion curves following patent expiry); and b) reconciling the cash flows to the Board approved Group level budgets and forecasts. Evaluating management’s assumptions related to the probability of technical and regulatory success and the amount and timing of projected future cash flows involved evaluating whether the assumptions used were reasonable through (1) comparing significant assumptions to external data and benchmarks; and (2) performing a retrospective comparison of past forecasted revenues to actual past performance.
Recognition and measurement of legal provisions and disclosure of contingent liabilities
As described in the Group Accounting Policies, Note 21 and Note 30 to the consolidated financial statements, the Group 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. 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. As at 31 December 2023 the Group held legal provisions of $1,016 million and disclosed the more significant legal matters. Provisions are recognised when either a legal or constructive obligation as a result of a past event exists, it is probable that an outflow of economic resources will be required to settle the obligation and a reasonable estimate can be made of the amount of the obligation. Provision is made where an adverse outcome is probable and associated costs, including related legal costs, can be estimated reliably. Management’s assessment as to whether or not to recognise provisions or assets, and of the amounts concerned, usually involves a series of complex judgements about future events and can rely heavily on estimates and assumptions. 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 disclosure of contingent liabilities is a critical audit matter are the significant judgement by management when assessing whether an adverse outcome is probable and can be estimated reliably, which in turn led to a high degree of auditor judgement and subjectivity in performing procedures and evaluating management’s assessment of the legal provisions and disclosures of contingent liabilities.
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 the liability of legal claims, including controls over determining the probability of a loss and whether the amount of loss can be reasonably estimated, as well as financial statement disclosures. These procedures also included, among others, (i) obtaining and evaluating letters of audit inquiry with internal and external legal counsel for significant litigation; (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 an adverse outcome is probable and estimated reliably; (iv) inspecting certain external legal documents; and (v) evaluating the sufficiency of the Group’s legal provisions and contingent liabilities disclosures.
Recognition, measurement and disclosure of tax liabilities for uncertain tax treatments
As described in the Group Accounting Policies and Note 30 to the consolidated financial statements, the Group faces a number of audits and reviews in jurisdictions around the world and, in some cases, is in dispute with the tax authorities. As at 31 December 2023 the total net tax liability recognised in respect of uncertain tax positions is $1,336 million and the potential for additional liabilities where the possibility of the additional liabilities falling due is more than remote is (a) $386 million related to transfer pricing matters including items under tax audit, and (b) $293 million related to other tax liabilities where the Group estimates the potential for additional liabilities above the amount provided. Tax liabilities recognised for uncertain tax treatments require management to make key judgements with respect to the outcome of current and potential future tax audits, and actual results could vary from these estimates. Accruals for tax liabilities are measured using either the most likely amount or the expected value amount depending on which method management expects to better predict the resolution of the uncertainty.
The principal considerations for our determination that performing procedures relating to recognition, measurement and disclosure of tax liabilities for uncertain tax treatments is a critical audit matter are the significant judgement made by management to estimate the tax liability, and the significant estimation uncertainty relative to the expectation of the resolution of tax audits or other disputes with tax authorities. This in turn led to a high degree of auditor judgement, subjectivity, and effort in performing procedures and evaluating management’s key judgements with respect to the outcome, estimation and recognition of current and potential future tax audits. In addition, the audit effort involved the use of professionals with specialised skill and knowledge.
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 accruals for tax liabilities. These procedures also included, among others, testing management’s process for determining tax liabilities and uncertain tax treatments for which no tax liability is recognised; i) evaluating the completeness of management’s assessment of the identification of tax liabilities and evaluating management’s process for estimating the possible outcomes of each tax liability; ii) obtaining the status and results of tax audits and discussions with the relevant tax authorities; iii) testing the completeness and accuracy of underlying data used in the estimate; iv) evaluating the reasonableness of key judgements related to the outcome of tax audits and tax liabilities using the most likely amount or expected value depending on the resolution of the uncertainty; and v) evaluating the sufficiency of the Group’s disclosures where no tax liability is recognised. Professionals with specialised skill and knowledge were used to assist in evaluating the method used by management to measure accruals for tax contingencies, and to evaluate management’s key judgements with respect to the outcome of tax audits considering the technical merits of tax treatments and advice, if any, received from the Group’s external advisors.
Valuation of defined benefit obligations (in the UK and Sweden)
As described in the Group Accounting Policies and Note 22 to the consolidated financial statements, the Group and most of its subsidiaries offer retirement plans which cover the majority of its employees. Several of these plans are defined benefit, where benefits are based on employees’ length of service and linked to their salary. As at 31 December 2023 the Group had defined benefit obligations of $7,907 million mainly in the UK and Sweden. Qualified independent actuaries have updated the actuarial valuations under IAS 19 for the major defined benefit schemes operated by the Group to 31 December 2023. In respect of defined benefit plans, obligations are determined using the projected unit credit method and are discounted to present value by reference to market yields on high quality corporate bonds. Given the extent of the assumptions used to determine the value of scheme liabilities, these are considered to be significant estimates. The assumptions which had the most material impact on the results of the Group were mortality rate (for the UK scheme only), discount rates and inflation levels (for both the UK and Sweden schemes).
The principal considerations for our determination that performing procedures relating to the valuation of defined benefit obligations (in the UK and Sweden) is a critical audit matter are the significant judgement made by management in determining the discount rate, inflation and mortality rates (UK) assumptions. This in turn led to a high degree of auditor judgement and subjectivity in applying procedures relating to these assumptions. In addition, the audit effort involved the use of professionals with specialised skill and knowledge to assist in performing these procedures and evaluating audit evidence.
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 and the accuracy of the obligations. These procedures also included, among others, (i) the involvement of professionals with specialised skill and knowledge to assist in developing an independent expectation of the defined benefit obligations for the UK and Sweden, (ii) comparing the independent estimate to management’s estimate to evaluate the reasonableness of management’s estimate, and (iii) testing the completeness and accuracy of the underlying data used in the models. Developing the independent estimate involved independently deriving inflation, discount rate and mortality assumptions by evaluating the specifics of each plan and, where applicable, considering national information, and comparing the discount and inflation rates with developed ranges of recent external reporting of other companies.
**/s/**PricewaterhouseCoopers LLP
London, United Kingdom
8 February 2024
We have served as the Group’s auditor since 2017.
ITEM 19. EXHIBITS(1)
| 1.1 | Articles of Association of AstraZeneca PLC (incorporated into this Form 20-F by reference to AstraZeneca PLC’s Form 6-K filed April 27, 2023 (File No. 001-11960)). | |
| 2.1 | Description of the registrant’s securities registered pursuant to Section 12 of the Securities and Exchange Act of 1934. | |
| 4.1 | Employment Agreement between AstraZeneca UK Limited and Pascal Soriot, dated December 15, 2016 (incorporated into this Form 20-F by reference to Exhibit 4.3 of AstraZeneca PLC’s Form 20-F filed March 7, 2017 (File No. 001-11960)). | |
| 4.2 | Employment Agreement between AstraZeneca UK Limited and Aradhana Sarin, dated August 1, 2021 (incorporated into this Form 20-F by reference to Exhibit 4.2 of AstraZeneca PLC’s Form 20-F filed February 22, 2022 (File No. 001-11960). | |
| 4.3 | | Form of Deed of Indemnity for Directors (used for all Directors from November 10, 2022) (incorporated into this Form 20-F by reference to Exhibit 4.3 of AstraZeneca PLC’s Form 20-F filed February 21, 2023 (File No. 001-11960)). |
| 8.1 | List of significant subsidiaries of AstraZeneca PLC. | |
| 12.1 | Certification of Pascal Soriot filed pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934. | |
| 12.2 | Certification of Aradhana Sarin filed pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934. | |
| 13.1 | Certification of Pascal Soriot and Aradhana Sarin furnished pursuant to 17 CFR 240.13a-14(b) and 18 U.S.C. 1350. | |
| 15.2 | Consent of PricewaterhouseCoopers LLP, independent registered public accounting firm. | |
| 15.3 | Consent of IQVIA Inc. | |
| 15.4 | Consent of Bureau Veritas UK Limited. | |
| 17.1 | | List of subsidiary guarantors and issuers of guaranteed securities. |
| | | |
| 97.1 | | AstraZeneca US Clawback Policy Applicable to Executive Officers. |
| | | |
| 101.INS | XBRL Instance Document. | |
| 101.SCH | XBRL Taxonomy Extension Schema. | |
| 101.CAL | XBRL Taxonomy Extension Scheme Calculation Linkbase. | |
| 101.DEF | XBRL Taxonomy Extension Scheme Definition Linkbase. | |
| 101.LAB | XBRL Taxonomy Extension Scheme Label Linkbase. | |
| 101.PRE | XBRL Taxonomy Extension Scheme Presentation Linkbase. |
| (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 2023 is not deemed to be filed as part of this Annual Report on Form 20-F. |
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 20, 2024 | ||
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
INDEX TO FINANCIAL STATEMENTS
| 1. | Consolidated Statement of Comprehensive Income | F-2 |
| 2. | Consolidated Statement of Financial Position | F-3 |
| 3. | Consolidated Statement of Changes in Equity | F-4 |
| 4. | Consolidated Statements of Cash Flows | F-5 |
| 5. | Group Accounting Policies | F-6 |
| 6. | Notes to the Group Financial Statements | F-14 |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.