ASTRAZENECA PLC
For the period ended Dec 31, 2024. Filed Feb 18, 2025.
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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.
FY2024 · Filed Feb 18, 2025
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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, 2024 |
| 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 0AAUnited Kingdom
(Address of principal executive offices)
Adrian KempAstraZeneca PLC1 Francis Crick AvenueCambridge Biomedical CampusCambridge CB2 0AAUnited KingdomTelephone: +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 * | |||
| 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 | ||
| 4.800% Notes due 2027 | | AZN 27B | | 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 | ||
| 4.850% Notes due 2029 | | AZN 29A | | 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 |
| 4.900% Notes due 2031 | | AZN 31A | | The Nasdaq Stock Market LLC |
| 4.875% Notes due 2033 | | AZN 33 | | The Nasdaq Stock Market LLC |
| 5.000% Notes due 2034 | | AZN 34 | | 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, 2024 was:
| Title of Class | Number of Shares Outstanding |
|---|---|
| Ordinary Shares of 25¢ each: | 1,550,546,239 |
| 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 2024 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 2024” included as exhibit 15.1 to this Form 20-F dated and submitted on February 18, 2025.
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 2024” 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 69, and the tables on pages 70 to 72, “Additional Information—Trade Marks” on page 239, “—Glossary” on pages 240 to 243 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 244, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 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 18, 2025. 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 139 to 147 of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 does not form part of, and is not incorporated into, this Form 20-F dated February 18, 2025.
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 65 and 66 of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025, 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 18, 2025, 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 | ||
| | | |
| 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. Projects have failed, and may fail in the future, 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 2024 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 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025.Launch activities have been delayed, and may be delayed in the future, 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 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 salesforce 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 United States and the European Medicines Agency in the European Union, 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; and> changes in prescribing habits.The ability to successfully carry out business in emerging markets can be more challenging than in established markets. Such challenges may include:> volatility in economic or political climates;> inadequate protection against crime (including counterfeiting, corruption and fraud); and> inadvertent breaches of local and international law. | | 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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| At AstraZeneca, our approach to pricing balances the priorities of patients, their physicians, payers, society and our business. Our four guiding principles – Access, Value, Sustainability and Equity – aligned to our overarching company values, form the cornerstones of our brand pricing strategies. Our prices are rooted in the assurance of our high-quality science, and the benefit this brings to patients. They also reflect holistic value, in the context of healthcare systems and market dynamics, affordability and equity; so that we can adapt our prices across the more than 100 countries in which we operate and help support long-term healthcare system resilience.Our pricing approach, as described in the previous paragraph, is a key contributor to our success. However, there are various external risk factors that could compromise our ability to execute our pricing strategies as planned. The market access environment is highly complex and subject to dynamic economic, political and social pressures. Globally, there are increasing cost-containment measures, greater calls for net price and R&D cost transparency, as well as early discussions toward pooled procurement mechanisms beyond emergency countermeasures and essential medicines. We have also experienced the first round of drug pricing system reforms in the United States, with associated uncertainty on the long-term impact. | | Continued deterioration of, or lack of improvement in, socioeconomic 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 healthcare 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, the Inflation Reduction Act (“IRA”) in the United States and joint procedures to evaluate comparative clinical effectiveness in the European Union 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. |
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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 and 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 continued inflationary pressures, 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 which are increasingly dependent on partner and vendor IT stability and data integrity. High availability IT systems remain a business imperative, providing our workforce with continuous access to collaboration environments, global communications channels, applications and data. In addition to availability and reliability, these systems must comply with provisions specified in data security, privacy and individual protection laws.Data is a commodity we prioritise continued access to and protection of. It is often characterised as strictly confidential information and examples of strictly confidential data include clinical trial records, personal information, IP, R&D data, and compliance information. 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’s IT systems and data are increasingly sophisticated. Threat actors include organised criminal groups, ‘hacktivists’, nation states, employees and others. Privacy legislation includes obligations to report data protection breaches to regulators and affected individuals within expedited timeframes.The internet is our primary critical business transaction channel. Internet availability is increasingly at risk due to geopolitical tensions and conflict. | | Disruption to our 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 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 and AI 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 requirements 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 and 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 European Union, China and the United States. | 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. 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 2025 will be to continue building talent and capability across our global hubs to ensure we are best positioned to support science and the business towards the Ambition 2030. |
| Legal, regulatory and compliance risks | Impact | |
|---|---|---|
| Failure to meet our sustainability targets, regulatory requirements and stakeholder expectations with respect to the environment | ||
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| Environmental issues will become more material as healthcare systems continue to adopt net-zero climate targets.Investors, governments and non-governmental organisations will increasingly scrutinise our environmental targets and performance.Environmental considerations are becoming embedded in the public procurement of 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 United States. 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 page 208 of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025. | | 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 211 of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025. | 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 205 to 207 of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025. | | 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. |
| | | |
| 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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| With an active presence in more than 80 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 internal control, financial reporting 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.The introduction of new legislation such as the failure to prevent fraud offence in the Economic Crime and Corporate Transparency Act (effective from September 1, 2025) may increase regulator focus on 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 United Kingdom 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, adversely impacting our financial position and requiring higher cash 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 in some pension schemes, significant collateral may need to be posted to meet margin requirements, which in extreme circumstances could lead to a short-term liquidity risk in these 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 81 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 211 to 212 of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025.Changes in tax laws 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 United Kingdom. The Company’s registered number is 2723534 and its registered office is at 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge CB2 0AA, United Kingdom (Tel: +44 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 United States. In 2021, the Group acquired Alexion, a rare disease business based in the United States.
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-denominated shares issued, credited as fully paid on the basis of one dollar-denominated share for each Zeneca share then held.
This was achieved by a reduction of capital under section 135 of the UK 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-denominated 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 74 to 75, “Strategic Report—Financial Review—Restructuring” on page 76, “Strategic Report—Financial Review—Acquisitions treated as Business combinations” and “—Acquisitions treated as asset acquisitions” on page 79, “Strategic Report—Financial Review—Investments, divestments and capital expenditure” on pages 80 to 81, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Board Leadership and Company Purpose” on page 91 and “Additional Information—Important information for readers of this Annual Report—AstraZeneca websites” on page 244, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 is incorporated by reference. Additionally, 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 the Form 20-F dated February 20, 2024 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 6, “Strategic Report—Chair’s Statement” on page 2, “Strategic Report—Chief Executive Officer’s Review” on pages 3 to 4, “Strategic Report—What science can do” on page 5, “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 58, “Strategic Report—Disclosure Statements—Our approach to Sustainability Reporting—UK Statutory sustainability reporting” on page 59, “Strategic Report—Disclosure Statements—Our approach to Sustainability Reporting—EU Corporate Sustainability Reporting Directive” and “—EU Taxonomy Disclosure” on pages 60 to 62, “Strategic Report—Risk Overview—Managing risk”,—Emerging risks”,—Climate risk”, “—Cybersecurity Risk” on page 64, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Further information on risk management and controls—Global Compliance and GIA” on page 93, “Corporate Governance—Corporate Governance Report—Principal Decisions in 2024—Acquisitions to strengthen the pipeline” on page 97, “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 166 to 168, “Additional Information—Sustainability supplementary information” on pages 233 to 238, and “Additional Information—Important information for readers of this Annual Report—Statements of competitive position, growth rates and sales” on page 244, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 is incorporated by reference.
Development Pipeline as at February 6, 2025
This section sets out AstraZeneca-sponsored or -directed trial New Molecular Entities (“NMEs”) and significant indications.
Anticipated data timing 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 | | | | | |||
| AZD0022 | | KRas G12D inhibitor | | | | solid tumours | |
| AZD0120 | | autologous anti-CD19 and anti-BCMA CAR-T cell immunotherapy | | | | multiple myeloma | |
| 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 | |
| AZD0754 | | STEAP2 CAR-T | | | | prostate cancer | |
| AZD1390 | | ATM inhibitor | | | | glioblastoma | |
| AZD2068 | | EGFR cMET radioconjugate | | | | solid tumours | |
| AZD3470 | | PRMT5 inhibitor | | | | classic Hodgkin lymphoma, solid tumours | |
| AZD5492 | | CD20 TITAN T cell engager | | | | haematology | |
| AZD5851 | | GPC3 CAR-T | | | | hepatocellular carcinoma | |
| AZD5863 | | CLDN18.2 x CD3 bispecific antibody (HBM7022) | | | | solid tumours | |
| AZD6422 | | CLDN18.2 CAR-T | | | | solid tumours | |
| AZD7003 (China) | | GPC3 CAR-T | | | | hepatocellular carcinoma/squamous non-small cell lung cancer | |
| AZD8421 | | CDK2 inhibitor | | | | solid tumours | |
| AZD9592 | | EGFR/cMET TOP1i ADC | | | | solid tumours | |
| AZD9829 | | CD123 TOP1i ADC | | | | acute myeloid leukaemia, myelodysplastic syndromes | |
| NT-112 | | TGFBR2 KO armored TCR-T targeting KRAS G12D | | (PP) | | solid tumour | |
| NT-125 | | autologous, fully-individualised, multi-specific TCR-T targeting neoantigens | | (PP) | | solid tumours | |
| NT-175 | | TGFBR2 KO armored TCR-T targeting TP53 R175H | | (PP) | | solid tumours | |
| volrustomig + lenvatinib | | PD-1/CTLA-4 bispecific mAb + VEGF | | | | advanced renal cell carcinoma | |
| CVRM | | | | | | ||
| AZD0233 | | CX3CR1 | | | | dilated cardiomyopathy | |
| AZD1705 | | lipid lowering | | | | cardiovascular disease | |
| AZD2373 | | podocyte health | | | | nephropathy | |
| AZD4144 | | inflammation modulator | | | | cardiorenal disease | |
| AZD9550 | | GLP-1R glucagon dual agonist | | | | non-alcoholic steatohepatitis | |
| Respiratory & Immunology | | | | | | ||
| AZD0120 | | autologous anti-CD19 and anti-BCMACAR-T cell immunotherapy | | | | systemic lupus erythematosus | |
| AZD1163 | | bispecific antibody | | | | rheumatoid arthritis | |
| AZD6793 | | IRAK4 inhibitor | | | | inflammatory diseases | |
| AZD6912 | | siRNA | | | | rheumatoid arthritis | |
| AZD8965 | | inhibition of arginase enzyme | | | | idiopathic pulmonary fibrosis | |
| Vaccines and Immune Therapies | | | | | | | |
| AZD0292 | | pseudomonas Psl-PcrV bispecific mAb | | | | non-CF bronchiectasis | |
| AZD5148 | | anti-clostridioides difficile TcdB mAb | | | | reduction of C. diff recurrence | |
| AZD7760 | | mAb combination targeting S aureusvirulence factors | | | | prevention of Staph aureus infection | |
| mRNA VLP vaccine | | mRNA-VLP vaccine | | | | prevention of COVID-19 | |
| Other Medicines | | | | | |||
| MEDI1814 | | amyloid beta mAb | | (PP) | | Alzheimer’s disease | |
| Rare Disease | | | | | |||
| ALXN1920 | | kidney-targeted factor H fusion protein | | | | nephrology | |
| ALXN2030 | | siRNA targeting complement C3 | | | | nephrology | |
| ALXN2080 | | oral factor D inhibitor | | | | healthy volunteers | |
Phase II
| Compound | Mechanism | AdditionalInformation | Area Under Investigation | ||||
|---|---|---|---|---|---|---|---|
| Oncology | | | | | |||
| AZD0486 SOUNDTRACK-B | | CD19/CD3 next-generation bispecific T-cell engager | | | | B-cell non-Hodgkin lymphoma | |
| AZD0901 | | CLDN18.2 MMAE ADC | | | | solid tumours | |
| AZD5335 | | anti-folate receptor alpha topoisomerase 1 inhibitor ADC | | | | ovarian cancer, lung adenocarcinoma | |
| AZD9574 | | PARP1 selective | | | | advanced solid malignancies | |
| camizestrant | | selective estrogen receptor degrader | | | | estrogen receptor +ve breast cancer | |
| ceralasertib | | ATR inhibitor | | | | solid tumours | |
| FPI-2265 | | PSMA radioconjugate | | (PP) | | prostate cancer | |
| IPH5201 + Imfinzi | | CD39 + PD-L1 | | (PP) | | neoadjuvant/adjuvant NSCLC | |
| puxitatug samrotecan (AZD8205) | | B7-H4 targeting ADC | | | | solid tumours | |
| rilvegostomig ARTEMIDE-01 | | PD-1/TIGIT bispecific mAb | | (PP) | | solid tumours | |
| saruparib | | PARP1 selective | | | | solid tumours | |
| volrustomig | | PD-1/CTLA-4 bispecific mAb | | | | solid tumours | |
| volrustomig eVOLVE-01 | | PD-1/CTLA-4 bispecific mAb | | | | NSCLC | |
| volrustomig eVOLVE-02 | | PD-1/CTLA-4 bispecific mAb | | | | cervical cancer, head and neck squamous cell carcinoma | |
| CVRM | | | | | | ||
| AZD0780 | | PCSK9 | | | | dyslipidaemia | |
| AZD2389 | | anti-fibrotic mechanism | | | | metabolic dysfunction-associated steatohepatitis | |
| AZD2693 | | NASH resolution | | | | non-alcoholic steatohepatitis | |
| AZD3427 | | relaxin mimetic | | | | heart failure | |
| AZD5004 | | oral GLP-1 receptor agonist | | | | T2D/chronic weight management | |
| AZD5462 | | RXFP1 agonist | | (PP) | | heart failure | |
| AZD6234 | | peptide | | | | chronic weight management in overweight or obesity | |
| balcinrenone/dapagliflozin | | MR modulator + SGLT2 inhibitor | | Farxiga in the US; Forxiga in rest of world | | CKD | |
| zibotentan/dapagliflozin | | endothelin A receptor antagonist/SGLT2 inhibitor | | dapagliflozin is marketed as Farxiga in the US; Forxiga in rest of world | | liver cirrhosis | |
| Respiratory & Immunology | | | | | | ||
| atuliflapon | | FLAP inhibitor | | | | asthma | |
| AZD4604 | | inhaled JAK1 inhibitor | | | | asthma | |
| AZD7798 | | humanised monoclonal antibody targets T cells subset | | | | Crohn’s disease | |
| AZD8630 | | inhaled TSLP FAb | | (PP) | | asthma | |
| tozorakimab FRONTIER 3 | | IL-33 mAb | | | | asthma | |
| Vaccine and Immune therapies | | | | | | | |
| IVX-A12 | | virus-like particle (VLP) vaccine | | IVX-A12 is a virus-like particle combination vaccine for the prevention of lower respiratory tract disease (LRTD) caused RSV and hMPV | | RSV and human metapneumovirus (hMPV) | |
| Other Medicines | | | | | |||
| MEDI0618 | | PAR2 antagonist mAb | | | | migraine | |
| MEDI7352 | | NGF/TNF bispecific mAb | | | | osteoarthritis pain and painful diabetic neuropathy | |
| Rare Disease | | | | | | ||
| MEDI1341 | | alpha synuclein mAb | | (PP) | | multiple system atrophy/Parkinson’s disease | |
Phase III/Pivotal Phase II/Registration (listed until launched in all applicable major markets)
| Compound | Mechanism | Area UnderInvestigation | AdditionalInformation | Data read-out/submissionstatus | |||||
|---|---|---|---|---|---|---|---|---|---|
| Oncology | | | | | | ||||
| AZD0486 SOUNDTRACK-F1 | | CD19/CD3 next-generation bispecific T-cell engager | | follicular lymphoma | | | | >2026 | |
| AZD0901 CLARITY-Gastric01 | | CLDN18.2 MMAE ADC | | gastric 2L+ | | | | 2026 | |
| camizestrant + CDK4/6i SERENA-6 | | selective estrogen receptor degrader + CDK4/6 inhibitors | | 1st-line HR+ HER2- ESR1m breast cancer | | | | H2 2025 | |
| camizestrant +palbociclib SERENA-4 | | selective estrogen receptor degrader + CDK4/6 inhibitor | | 1st-line HR+ HER2- breast cancer | | | | 2026 | |
| camizestrant CAMBRIA-1 | | selective estrogen receptor degrader | | HR+ HER2- extended adjuvant breast cancer | | | | >2026 | |
| camizestrant +/- abemaciclib CAMBRIA-2 | | selective estrogen receptor degrader + CDK4/6 inhibitor | | ER+/HER2- early breast cancer | | | | >2026 | |
| ceralasertib +Imfinzi LATIFY | | ATR inhibitor + PDL-1 mAb | | NSCLC | | | | H2 2025 | |
| Datroway (datopotamab deruxtecan) TROPION-Breast01 | | TROP2 ADC | | 2-3L HR+ HER2- breast cancer | | (PP) | | Launched | |
| Imfinzi + Imjudo HIMALAYA | | PD-L1 mAb + CTLA-4 mAb | | 1st-line hepatocellular carcinoma | | | Launched | | |
| Imfinzi +/- oleclumab +/- monalizumab PACIFIC-9 | | PD-L1 + NKG2A or PD-L1 + CD73 | | unresectable Stage III NSCLC | | (PP) | | 2026 | |
| rilvegostomig ARTEMIDE-Biliary01 | | PD-1/TIGIT bispecific mAb | | adjuvant biliary tract cancer | | (PP) | | >2026 | |
| rilvegostomig ARTEMIDE-Lung02 | | PD-1/TIGIT bispecific mAb | | squamous NSCLC 1L | | (PP) | | >2026 | |
| rilvegostomig ARTEMIDE-Lung03 | | PD-1/TIGIT bispecific mAb | | non-squamous NSCLC 1L | | (PP) | | >2026 | |
| saruparib EvoPAR-Breast01 | | PARP1Sel | | BRCA/PALB2m HR+ve metastatic breast cancer | | | | >2026 | |
| saruparib EvoPAR-Prostate01 | | PARP1Sel | | metastatic castration-sensitive prostate cancer | | | | >2026 | |
| Truqap + Faslodex CAPItello-291 | | AKT inhibitor + fulvestrant | | 2nd-line and beyond in AI resistant locally advanced (inoperable) or metastatic breast cancer | | | Launched | | |
| volrustomig eVOLVE-Cervical | | PD-1/CTLA-4 bispecific mAb | | high-risk locally advanced cervical cancer | | | | >2026 | |
| volrustomig eVOLVE-HNSCC | | PD-1/CTLA-4 bispecific mAb | | unresected locally advanced head and neck squamous cell carcinoma | | | | >2026 | |
| volrustomig eVOLVE-Lung02 | | PD-1/CTLA-4 bispecific mAb | | 1L metastatic NSCLC | | | | >2026 | |
| volrustomig eVOLVE-Meso | | PD-1/CTLA-4 bispecific mAb | | 1L unresectable malignant pleural mesothelioma | | | | >2026 | |
| CVRM | | | | | | | |||
| Andexxa | | anti-factor Xa reversal | | acute major bleed | | | | Launched | |
| balcinrenone/dapagliflozin | | MR modulator + SGLT2 inhibitor | | heart failure with CKD | | Farxiga in the US; Forxiga in rest of world. | | >2026 | |
| baxdrostat BaxHTN | | aldosterone synthase inhibitor | | hypertension | | | | H2 2025 | |
| baxdrostat/dapagliflozin | | aldosterone synthase inhibitor and reversible inhibitor of SGLT2 | | CKD | | | | >2026 | |
| Wainua | | 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 | | dapagliflozin is marketed as Farxiga in the US; Forxiga in rest of world. | | >2026 | |
| 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 | | | | 2026 | |
| tozorakimab TILIA | | IL-33 mAb | | severe viral lower respiratory tract disease | | | | 2026 | |
| Vaccine and Immune Therapies | | | | | | ||||
| Kavigale (sipavibart) SUPERNOVA | | SARS-CoV-2 LAAB | | prevention of COVID-19 | | | | Approved | |
| Rare Disease | | | | | | ||||
| acoramidis | | oral TTR stabiliser | | transthyretin amyloid cardiomyopathy | | (PP) | | Submitted | |
| ALXN2220 DepleTTR-CM | | transthyretin depleter | | transthyretin amyloid cardiomyopathy | | (PP) | | >2026 | |
| anselamimab | | fibril-reactive mAb | | amyloid light chain amyloidosis | | | | H2 2025 | |
| efzimfotase alfa | | next generation TNSALP ERT | | hypophosphatasia | | | | 2026 | |
| eneboparatide CALYPSO | | parathyroid hormone receptor 1 | | hypoparathyroidism | | | | H1 2025 | |
| gefurulimab PREVAIL | | humanised bispecific VHH antibody | | generalised myasthenia gravis | | | | H2 2025 | |
Significant Life-cycle Management
Anticipated data timing and submission status is provided for assets in Phase III or beyond. Projects in Phase III unless otherwise noted.
| Compound | Mechanism | Area UnderInvestigation | AdditionalInformation | Data read-out/submissionstatus | |||||
|---|---|---|---|---|---|---|---|---|---|
| | | | | | | | | | |
| Oncology | | | | | | | | | |
| Calquence + R-CHOP ESCALADE | | BTK inhibitor + R-CHOP | | 1st-line diffuse large B cell lymphoma | | | | >2026 | |
| Calquence + venetoclax + obinutuzumab AMPLIFY | | BTK inhibitor + BCL-2 inhibitor + anti-CD20 mAb | | 1st-line chronic lymphocytic leukaemia | | | | Accepted | |
| Calquence ECHO | | BTK inhibitor | | 1st-line mantle cell lymphoma | | (PP) | | Launched | |
| Calquence ELEVATE-TN ChangE (China) | | BTK inhibitor | | 1st-line chronic lymphocytic leukaemia | | (PP) | | Launched | |
| Datroway + Imfinzi AVANZAR | | TROP2 ADC + PD-L1 + CTx | | non-squamous or non-squamous TROP2+ NSCLC 1L | | (PP) | | H2 2025 | |
| Datroway TROPION-Breast02 | | TROP2 ADC | | 1st-line triple negative breast cancer | | (PP) | | H1 2025 | |
| Datroway +/- Imfinzi TROPION-Breast03 | | TROP2 ADC +/- PD-L1 | | adjuvant residual disease triple negative breast cancer | | (PP) | | 2026 | |
| Datroway +/- Imfinzi TROPION-Breast04 | | TROP2 ADC +/- PD-L1 | | neoadjuvant/adjuvant triple negative or HR-low/HER2-negative breast cancer | | (PP) | | >2026 | |
| Datroway +/- Imfinzi TROPION-Breast05 | | TROP2 ADC + PD-L1 | | 1st-line triple negative breast cancer | | (PP) | | 2026 | |
| Datroway TROPION-Lung05 | | TROP2 ADC | | advanced or metastatic NSCLC with an EGFR mutation and progressed on prior systemic therapies, including TKIs and platinum-based chemotherapy | | (PP) | | Accepted | |
| Datroway + pembrolizumab TROPION-Lung07 | | TROP2 ADC | | L NSCLC PD-L1 <50% non-squamous | | (PP) | | 2026 | |
| Datroway TROPION-Lung08 | | TROP2 ADC | | 1L metastatic NSCLC without actionable genomic alterations and PD-L1 TPS ≥50% | | (PP) | | 2026 | |
| Datroway + rilvegostomig TROPION-Lung10 | | TROP2 ADC + PD-1/TIGIT bispecific mAb | | locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥50%) and without actionable genomic alterations | | (PP) | | >2026 | |
| Datroway + rilvegostomig TROPION-Lung12 | | TROP2 ADC + PD-1/TIGIT bispecific mAb | | Stage I adenocarcinoma NSCLC who are ctDNA-positive or have high-risk pathological features | | (PP) | | >2026 | |
| Datroway + Tagrisso TROPION-Lung14 | | TROP2 ADC + EGFR inhibitor | | 1L EGFRm NSCLC | | (PP) | | >2026 | |
| Datroway + Tagrisso TROPION-Lung15 | | TROP2 ADC + EGFR inhibitor | | 2L advanced or metastatic EGFRm NSCLC | | (PP) | | 2026 | |
| Enhertu (platform) DESTINY-Breast07 | | HER2 targeting ADC | | HER2+ breast cancer | | (PP) Phase II LCM | | | |
| Enhertu + rilvegostomig DESTINY-BTC01 | | HER2 targeting ADC + PD-1/TIGIT bispecific mAb | | 1L HER2+ biliary tract cancer | | | >2026 | | |
| Enhertu DESTINY-Breast05 | | HER2 targeting ADC | | HER2+ post-neoadjuvant high-risk breast cancer | | (PP) | | H2 2025 | |
| Enhertu DESTINY-Breast06 | | HER2 targeting ADC | | post-ET HER2-low and -ultralow/ HR+ breast cancer 2L | | (PP) | | Launched | |
| Enhertu DESTINY-Breast09 | | HER2 targeting ADC | | 1st-line HER2+ breast cancer | | (PP) | | H2 2025 | |
| Enhertu DESTINY-Breast11 | | HER2 targeting ADC | | neoadjuvant HER2+ breast cancer | | (PP) | | H1 2025 | |
| Enhertu DESTINY-Gastric04 | | HER2 targeting ADC | | 2nd-line HER2+ gastric cancer | | (PP) | | H2 2025 | |
| Enhertu DESTINY-Lung04 | | HER2 targeting ADC | | 1st-line HER2m NSCLC | | (PP) | | H2 2025 | |
| Enhertu DESTINY-PanTumor03 (China) | | HER2 targeting ADC | | HER2 expressing solid tumours | | (PP) Phase II LCM | | H2 2025 | |
| Enhertu DESTINY-PanTumour01 | | HER2 targeting ADC | | HER2 mutant tumours | | (PP) Phase II LCM | | | |
| Enhertu DESTINY-PanTumour02 | | HER2 targeting ADC | | HER2 expressing solid tumours | | (PP) Phase II LCM | | Launched | |
| 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 (platform) NeoCOAST-2 | | PD-L1 mAb + multiple novel oncology therapies | | non-small cell lung cancer | | (PP) | | | |
| Imfinzi + CRT KUNLUN | | PD-L1 mAb + CRT | | locally advanced oesophageal squamous cell carcinoma | | | 2026 | | |
| Imfinzi + CRT PACIFIC-5 (China) | | PD-L1 mAb + CRT | | locally-advanced (Stage III) NSCLC | | (PP) | | Q3 2024 | |
| Imfinzi + CTx neoadjuvant AEGEAN | | PD-L1 mAb + CTx | | locally-advanced (Stage II-III) NSCLC | | | | Launched | |
| Imfinzi + CTx NIAGARA | | PD-L1 mAb + CTx | | muscle invasive bladder cancer | | | | Submitted | |
| Imfinzi + domvanalimab (AB154) PACIFIC-8 | | PD-L1 mAb + TIGIT | | unresectable Stage III NSCLC | | (PP) | | >2026 | |
| Imfinzi + EV +/- Imjudo VOLGA | | PD-L1 + nectin-4 targeting ADC +/- CTLA-4 | | muscle invasive bladder cancer | | | | H2 2025 | |
| Imfinzi + FLOT MATTERHORN | | PD-L1 mAb + CTx | | neoadjuvant/adjuvant gastric cancer | | (PP) | | H2 2025 | |
| Imfinzi + Imjudo +SoC NILE | | PL-L1 mAb + CTLA-4 mAb + SoC | | 1st-line urothelial cancer | | | | H2 2025 | |
| Imfinzi + Imjudo + TACE +/- lenvatinib EMERALD-3 | | PD-L1 + CTLA-4 + VEGF +/- chemoembolisation | | locoregional hepatocellular carcinoma | | | | 2026 | |
| Imfinzi + VEGF + TACE EMERALD-1 | | PD-L1 mAb + VEGF + TACE | | locoregional hepatocellular carcinoma | | (PP) | | Q4 2023 | |
| Imfinzi + VEGF EMERALD-2 | | PD-L1 mAb + VEGF | | adjuvant hepatocellular carcinoma | | (PP) | | 2026 | |
| Imfinzi +/- Imjudo + CRT ADRIATIC | | PD-L1 mAb +/- CTLA-4 mAb + CRT | | 1st-line limited-stage SCLC | | (PP) | | Launched | |
| Imfinzi +/- Imjudo + CTx POSEIDON | | PD-L1 mAb +/- CTLA-4 mAb + CTx | | 1st-line NSCLC | | | | Launched | |
| Compound | Mechanism | Area UnderInvestigation | AdditionalInformation | Data read-out/submissionstatus | |||||
|---|---|---|---|---|---|---|---|---|---|
| | | | | | | | | | |
| Imfinzi post-SBRT PACIFIC-4 | | PD-L1 mAb post-SBRT | | Stage I/II NSCLC | | (PP) | | 2026 | |
| Imfinzi POTOMAC | | PD-L1 mAb | | non-muscle invasive bladder cancer | | | | H2 2025 | |
| 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) | | Q2 2023 | |
| Lynparza + Imfinzi DUO-E | | PARP inhibitor + PD-L1 mAb | | 1st-line endometrial cancer | | (PP) | | Launched | |
| Lynparza MONO-OLA1 | | PARP inhibitor | | 1st-line BRCAwt ovarian cancer | | (PP) | | H1 2025 | |
| Orpathys + Imfinzi SAMETA | | MET inhibitor + PD-L1 mAb | | 1st-line papillary renal cell carcinoma | | (PP) | | H2 2025 | |
| Tagrisso + Orpathys SAFFRON | | EGFR inhibitor + MET inhibitor | | advanced EGFRm NSCLC | | (PP) | | H2 2025 | |
| 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 | | | | Q4 2024 | |
| Tagrisso ADAURA2 | | EGFR inhibitor | | adjuvant EGFRm NSCLC Stage Ia2-Ia3 following complete tumour resection | | | | >2026 | |
| Tagrisso LAURA | | EGFR inhibitor | | Stage III EGFRm non-small cell lung cancer | | | | Launched | |
| Tagrisso ORCHARD platform study | | EGFR inhibitor + multiple novel oncology therapies | | 2nd-line EGFRm osimertinib-resistant NSCLC | | (PP) Phase II LCM | | | |
| Truqap | | AKT inhibitor | | prostate cancer | | Phase II LCM | | | |
| Truqap + abiraterone CAPItello-281 | | AKT inhibitor + abiraterone | | PTEN deficient metastatic hormone sensitive prostate cancer | | | | Q4 2024 | |
| Truqap + docetaxel CAPItello-280 | | AKT inhibitor + docetaxel | | mCRPC prostate cancer | | | | 2026 | |
| Truqap + 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 | | Phase Ib/III | | >2026 | |
| CVRM | | | | | | | | | |
| Wainua | | ligand-conjugated antisense | | patients with hereditary or wild-type transthyretin-mediated amyloid cardiomyopathy (ATTR CM) | | (PP) | | 2026 | |
| Respiratory & Immunology | | | | | | | | | |
| Breztri/Trixeo (PT010) KALOS LOGOS | | LABA/LAMA/ICS | | asthma | | Breztri in Japan, China and the US. Trixeo in the EU. | | H1 2025 | |
| Breztri/Trixeo ATHLOS | | LABA/LAMA/ICS | | COPD cardiopulmonary exercise test (CPET) trial | | | | H2 2025 | |
| Breztri/Trixeo THARROS | | LABA/LAMA/ICS | | cardiopulmonary outcomes trial in COPD | | (PP) | | >2026 | |
| Fasenra MANDARA | | IL-5R mAb | | eosinophilic granulomatosis with polyangiitis | | | | Launched | |
| Fasenra NATRON | | IL-5R mAb | | hypereosinophilic syndrome | | | | H1 2025 | |
| Fasenra RESOLUTE | | IL-5R mAb | | chronic obstructive pulmonary disease | | (PP) | | H2 2025 | |
| Saphnelo DAISY | | type I IFN receptor mAb | | systemic sclerosis | | (PP) | | 2026 | |
| Saphnelo IRIS | | type I IFN receptor mAb | | lupus nephritis | | (PP) | | 2026 | |
| Saphnelo JASMINE | | type I IFN receptor mAb | | myositis | | (PP) | | >2026 | |
| Saphnelo LAVENDER | | type I IFN receptor mAb | | CLE | | (PP) | | >2026 | |
| Saphnelo TULIP-SC | | type I IFN receptor mAb | | systemic lupus erythematosus (subcutaneous) | | (PP) | | H2 2025 | |
| Tezspire COURSE | | TSLP mAb | | chronic obstructive pulmonary disease | | (PP) Phase II LCM | | | |
| Tezspire CROSSING | | TSLP mAb | | eosinophilic oesophagitis | | (PP) | | 2026 | |
| Tezspire WAYPOINT | | TSLP mAb | | nasal polyps | | (PP) | | Q4 2024 | |
| Rare Disease | | | | | | | | | |
| Koselugo KOMET | | MEK inhibitor | | neurofibromatosis type 1 adult | | (PP) | | Submitted | |
| Ultomiris | | anti-complement C5 mAb | | generalised myasthenia gravis | | | | Launched | |
| Ultomiris | | anti-complement C5 mAb | | proliferative lupus nephritis | | Phase II LCM | | | |
| Ultomiris | | anti-complement C5 mAb | | haematopoietic stem cell transplant–associated thrombotic microangiopathy | | | | H2 2025 | |
| Ultomiris ARTEMIS | | anti-complement C5 mAb | | cardiac surgery-associated acute kidney injury | | | | 2026 | |
| Ultomiris CHAMPION-NMOSD | | anti-complement C5 mAb | | neuromyelitis optica spectrum disorder | | | | Launched | |
| Ultomiris I CAN | | anti-complement C5 mAb | | immunoglobulin A nephropathy | | | | >2026 | |
Patent Expiries of Key Marketed Products as at February 6, 2025
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 205 to 206 of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025, 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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| · · · · · · · · · · · · US · · Sales Ex-US | ||||||||||||||||||||||
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| Key Marketed products · Description · US · China · EU1 · Japan · 2024 · 2023 · 2022 · 2024 · 2023 · 2022 | ||||||||||||||||||||||
| 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 | 2,190 | 1,815 | 1,657 | 939 | 699 | 400 | ||||||||||
| Datroway (Datopotama deruxtecan) | A TROP2-directed antibody drug conjugate (ADC) comprised of a humanised anti-TROP2 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers, indicated for patients with previously treated metastatic HR-positive, HER2-negative breast cancer. | 2034 | 2034 | | 2034 | | 3 | — | | — | — | — | — | — | ||||||||
| Enhertu4 (trastuzumab deruxtecan) | A HER2-directed ADC indicated for HER2-positive, HER2-low and HER2-ultralow 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 | | 3 | — | — | — | | 545 | 261 | 79 | |||||||||
| 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 (SCLC) 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 | 2,603 | 2,171 | 1,539 | 2,114 | 1,848 | 1,232 | |||||||||||
| 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 | | 2031 | | 180 | | 146 | | 13 | | 101 | | 72 | | — |
| 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. | 2024, 2027, 2024-2041 | 2024, 2024-2029 | 2029, 2024-2029 | 2029, 2024-2034 | 1,332 | 1,254 | 1,226 | 1,740 | 1,557 | 1,412 | |||||||||||
| Orpathys (savolitinib) | An oral, potent and highly selective MET-TKI indicated for NSCLC with MET gene alterations. | 2030 | 2030 | 2030 | 2030 | — | — | — | 44 | 44 | 33 | |||||||||||
| Tagrisso (osimertinib) | An EGFR-TKI indicated for early- and late-stage EGFRm NSCLC. | 2032, 2035 | 2032, 2035 | 2032, 2035 | 2034, 2035 | 2,763 | 2,276 | 2,007 | 3,817 | 3,523 | 3,437 | |||||||||||
| 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 | 408 | 6 | — | 22 | — | — | |||||||||||
| CVRM | | | | | | | | | | | | |||||||||||
| Andexxa/ Ondexxya (andexanet alfa) | A factor Xa inhibitor (apixaban and rivaroxaban) reversal agent. | 2032, 2028–2037 | 2028, 2030–2035 | 2028, 2030–2037 | 2028, 2030–2037 | 81 | 75 | 77 | 138 | 107 | 73 | |||||||||||
| 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 | | 2037 | | 2025, 2037 | | 2024, 2025-2030 | | 751 | | 744 | | 744 | | 582 | | 580 | | 614 |
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| · · · · · · · · · · · · · · · · · · Aggregate Product | ||||||||||||||||||||||
| · · · · · · · · · · · · US · · Sales Ex-US | ||||||||||||||||||||||
| · · · · · · · · · · · · Product Sales ($m) · · ($m) | ||||||||||||||||||||||
| Key Marketed products · Description · US · China · EU1 · Japan · 2024 · 2023 · 2022 · 2024 · 2023 · 2022 | ||||||||||||||||||||||
| Farxiga/ Forxiga (dapagliflozin) | A sodium-glucose cotransporter 2 (SGLT-2 inhibitor) indicated for adult patients with type-2 diabetes (T2D) or in adults with or without T2D with heart failure with reduced ejection fraction or chronic kidney disease (CKD). Approved in the United States to improve glycaemic control in paediatric patients with T2D aged 10 years and older. | 2026, 2025-2040 | 2027-2041 | 7 | 2028, 2027, 2028 | 2 | 2024-2025, 2028-2040 | 1,750 | 1,451 | 1,071 | 5,906 | 4,512 | 3,310 | |||||||||
| Xigduo/ Xigduo XR8 (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. | 2026, 2027-2030 | 2027, 2030 | 7 | 2028, 2027 2, 2030 | | 2024-2025, 2027-2030 | — | — | — | — | — | — | |||||||||
| 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 | | 2033-2034 | 7 | 2032 | | 2035-2037 | | 256 | | 214 | | 170 | | 286 | | 198 | | 119 |
| Roxadustat9 | | An oral hypoxia-inducible factor prolyl hydroxylase inhibitor indicated for the treatment of anaemia from CKD. | | | 3 | 2024, 2024-2033 | | | 3 | | 3 | — | | — | | — | | 331 | | 271 | | 197 |
| Wainua/ Wainzua (eplontersen) | | Wainua injection, for subcutaneous use, is a prescription medicine used to treat adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis. | | 2025-2034 | | 2034 | | 2034 | | 2034 | | 85 | | — | | — | | — | | — | | — |
| Respiratory & Immunology | | | | | | | | | | | ||||||||||||
| Airsupra (albuterol/budesonide) | A first-in-class, fixed-dose combination rescue medication for asthma in the United States 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 | 66 | — | — | — | — | — | ||||||||||
| Breztri/Trixeo Aerosphere (budesonide/ glycopyrrolate/formoterol) | A fixed-dose triple combination of an ICS, a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-agonist (LABA) delivered in an Aerospace pMDI, used for the long-term maintenance treatment of COPD. | 2030-2031, 2038 | 2030, 2038 | 2030, 2038 | | 2030-2034, 2038 | 516 | 383 | 239 | 462 | 294 | 159 | ||||||||||
| 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 and for eosinophilic granulomatosis with polyangiitis (EGPA). | 2024, 2028-2034 | 2028 | 2025, 2028-2034 | | 2025, 2034 | 1,049 | 992 | 906 | 640 | 561 | 490 | ||||||||||
| 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 | 425 | 260 | 111 | 49 | 20 | 5 | ||||||||||
| Symbicort (budesonide/ formoterol) | A combination of an ICS and a fast-onset LABA to treat asthma and/or COPD either as Symbicort Turbuhaler or Symbicort pMDI. | 2025- 2029 | 10 | expired | expired | | expired | 1,187 | 726 | 973 | 1,692 | 1,636 | 1,565 | |||||||||
| Tezspire11 (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 | — | — | — | 248 | 86 | 4 | ||||||||||
| Vaccines & Immune Therapies | | | | | | | | | | | | | | | | | | | | | | |
| Beyfortus12 (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, 2038-2040 | | 2038 | | 2035 | | 2035, 2038 | | 232 | | 87 | | — | | 86 | | 19 | | — |
| FluMist (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 | 13 | 28 | | 23 | | 21 | | 230 | | 193 | | 154 |
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| · · · · · · · · · · · · · · · · · · Aggregate Product | ||||||||||||||||||||||
| · · · · · · · · · · · · US · · Sales Ex-US | ||||||||||||||||||||||
| · · · · · · · · · · · · Product Sales ($m) · · ($m) | ||||||||||||||||||||||
| Key Marketed products · Description · US · China · EU1 · Japan · 2024 · 2023 · 2022 · 2024 · 2023 · 2022 | ||||||||||||||||||||||
| Rare Disease · · · · · · · · · · · · · · · · · · · · · | ||||||||||||||||||||||
| Kanuma (sebelipase alfa) | | A recombinant form of the human lysosomal acid lipase (LAL). The enzyme replacement therapy is for the treatment of LAL deficiency. | | 2031 | | 2031 | | 2031, 2026-2037 | | 2031, 2032 | | 100 | | 85 | | 77 | | 109 | | 86 | | 83 |
| Koselugo14 (selumetinib) | | A kinase inhibitor that blocks specific enzymes (MEK1 and MEK2) for the treatment of patients with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. | | 2028 15, 2026-2029 | | 2026-2029 | | 2026-2029 | | 2029-2031 | | 212 | | 195 | | 162 | | 319 | | 136 | | 46 |
| Soliris (eculizumab) | A C5 complement inhibitor for the treatment of paroxysmal nocturnal haemoglobinuria, atypical haemolytic uraemic syndrome, generalised myasthenia gravis and neuromyelitis optica spectrum disorder. | 2027 16, 2025-2032 | | 2029 | 2027, 2029 | | 2027, 2029 | 1,523 | 1,734 | 2,180 | 1,065 | 1,411 | 1,582 | |||||||||
| Strensiq (asfotase alfa) | | A targeted enzyme replacement therapy for patients with hypophosphatasia. | | 2025-2029, 2035-2038 | | | | 2025-2031, 2036 | | 2028, 2035-2036 | | 1,167 | | 937 | | 769 | | 249 | | 215 | | 189 |
| Ultomiris (ravulizumab) | A long-acting C5 complement inhibitor for the treatment of paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uraemic syndrome (aHUS), generalised myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). | 2035, 2038 | 2035, 2038 | 2035, 2038-2040 | 2038, 2038 | 2,261 | 1,750 | 1,136 | 1,663 | 1,251 | 829 | |||||||||||
| Voydeya17 (danicopan) | A first-in-class oral, Factor D complement inhibitor for certain adults with PNH as add-on therapy to ravulizumab or eculizumab. | 2035, 2038 | 2035 | 2035 | 2035 | — | — | — | — | — | | — | ||||||||||
Notes
Crestor, Nexium, Pulmicort, Seloken, Synagis and Zoladexare key marketed products which have lost patent protection in all major markets.
| 1 | Expiry in major EU markets, which includes the United Kingdom. |
| 2 | The patent is the subject of a pending opposition proceeding at the European Patent Office (EPO). |
| 3 | AstraZeneca does not have commercialisation rights. |
| 4 | AstraZeneca has recorded $1,437 million of Alliance Revenue in relation to this product in 2024 (2023: $1,022 million; 2022: $523 million), as per the “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 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025. |
| 5 | Prior to 2024, Imjudo Product Sales are included in the Imfinzi Product Sales figure included in “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 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025. |
| 6 | In addition to any Product Sales, AstraZeneca has also recorded $600 million of Collaboration Revenue in relation to this product in 2024 (2023: $245 million; 2022: $355 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 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025. |
| 7 | The patent is the subject of a pending invalidation proceeding at China National Intellectual Property Administration. |
| 8 | Xigduo/Xigduo XR revenues are combined with Farxiga/Forxiga. Comparative revenues for years 2023 and 2022 have been revised to reflect this change. |
| 9 | AstraZeneca has recorded $6 million of Alliance Revenue in relation to this product in 2024 (2023: $5 million; 2022: $5 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 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025. |
| 10 | Patent expiry information relates to the Symbicort pMDI product, including any granted Paediatric Exclusivity term. |
| 11 | AstraZeneca has recorded $436 million of Alliance Revenue in relation to this product in 2024 (2023: $259 million; 2022: $79 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 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025. |
| 12 | AstraZeneca has recorded $237 million of Alliance Revenue in relation to this product in 2024 (2023: $57 million; 2022: $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 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025. |
| 13 | Rights licensed to Daiichi Sankyo, Inc. |
| 14 | In addition to any Product Sales, AstraZeneca also has recorded $100 million of Collaboration Revenue in relation to this product in 2024 (2023: $nil; 2022: $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 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2024. |
| 15 | Date represents expiry of a pending SPC/PTE and/or Paediatric Exclusivity period. |
| 16 | Settled with Amgen and Samsung Bioepis for licensed biosimilar entry date of March 1, 2025. |
| 17 | Voydeya revenues are combined with Ultomiris. |
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 | |||||||||||||||||||
| 2024 | | $m | % | % | | $m | % | | $m | % | % | | $m | % | % | | $m | % | % |
| Oncology: · · · · · | |||||||||||||||||||
| Tagrisso | | 6,580 | 13 | 16 | | 2,763 | 21 | | 1,755 | 8 | 16 | | 1,301 | 16 | 15 | | 761 | (3) | 4 |
| Imfinzi | | 4,717 | 17 | 21 | | 2,603 | 20 | | 479 | 35 | 59 | | 948 | 28 | 27 | | 687 | (8) | (2) |
| Calquence | | 3,129 | 24 | 25 | | 2,190 | 21 | | 153 | 56 | 79 | | 656 | 33 | 32 | | 130 | 20 | 22 |
| Lynparza | | 3,072 | 9 | 11 | | 1,332 | 6 | | 655 | 21 | 30 | | 832 | 13 | 12 | | 253 | (10) | (5) |
| Enhertu | | 545 | n/m | n/m | | — | — | | 350 | n/m | n/m | | 126 | n/m | n/m | | 69 | n/m | n/m |
| Zoladex | | 1,058 | 11 | 17 | | 16 | 14 | | 795 | 16 | 23 | | 148 | 12 | 10 | | 99 | (16) | (12) |
| Imjudo | | 281 | 29 | 31 | | 180 | 23 | | 16 | n/m | n/m | | 36 | n/m | n/m | | 49 | (5) | 2 |
| Truqap | | 430 | n/m | n/m | | 408 | n/m | | 2 | n/m | n/m | | 12 | n/m | n/m | | 8 | n/m | n/m |
| Orpathys | | 44 | (1) | 1 | | — | — | | 44 | (1) | 1 | | — | — | — | | — | — | — |
| Others | | 419 | (19) | (14) | | 18 | (51) | | 253 | (18) | (12) | | 23 | (30) | (30) | | 125 | (13) | (6) |
| Total Oncology | | 20,275 | 18 | 21 | | 9,510 | 23 | | 4,502 | 18 | 28 | | 4,082 | 23 | 22 | | 2,181 | (4) | 2 |
| BioPharmaceuticals: | | | | | | ||||||||||||||
| CVRM | | | | | | ||||||||||||||
| Farxiga | | 7,656 | 28 | 31 | | 1,750 | 21 | | 2,853 | 29 | 35 | | 2,634 | 40 | 39 | | 419 | — | 6 |
| Brilinta | | 1,333 | 1 | 2 | | 751 | 1 | | 294 | 3 | 10 | | 268 | (1) | (2) | | 20 | (17) | (16) |
| Crestor | | 1,153 | 4 | 8 | | 46 | (16) | | 934 | 8 | 12 | | 37 | (29) | (30) | | 136 | (2) | 5 |
| Seloken/Toprol-XL | | 605 | (5) | — | | — | (42) | | 589 | (5) | — | | 13 | 13 | 12 | | 3 | (53) | (44) |
| Lokelma | | 542 | 32 | 34 | | 256 | 20 | | 86 | 73 | 79 | | 92 | 59 | 58 | | 108 | 20 | 29 |
| Roxadustat | | 331 | 22 | 24 | | — | — | | 331 | 22 | 24 | | — | — | — | | — | — | — |
| Andexxa | | 219 | 20 | 22 | | 81 | 7 | | 3 | n/m | n/m | | 80 | 30 | 28 | | 55 | 22 | 31 |
| Wainua | | 85 | n/m | n/m | | 85 | n/m | | — | — | — | | — | — | — | | — | — | — |
| Others | | 524 | (24) | (22) | | 106 | (50) | | 249 | (13) | (9) | | 146 | (13) | (12) | | 23 | 18 | 20 |
| Total CVRM | | 12,448 | 18 | 20 | | 3,075 | 12 | | 5,339 | 16 | 22 | | 3,270 | 31 | 30 | | 764 | 3 | 9 |
| BioPharmaceuticals: | | | | | | ||||||||||||||
| Respiratory & Immunology | | | | | | ||||||||||||||
| Symbicort | | 2,879 | 22 | 25 | | 1,187 | 63 | | 805 | 7 | 16 | | 559 | 2 | 1 | | 328 | (2) | — |
| Fasenra | | 1,689 | 9 | 9 | | 1,049 | 6 | | 92 | 44 | 55 | | 404 | 14 | 13 | | 144 | 1 | 6 |
| Pulmicort | | 682 | (4) | (1) | | 6 | (77) | | 568 | (1) | 3 | | 71 | 5 | 3 | | 37 | (12) | (10) |
| Breztri | | 978 | 44 | 46 | | 516 | 35 | | 245 | 52 | 57 | | 143 | 78 | 77 | | 74 | 41 | 47 |
| Tezspire | | 248 | n/m | n/m | | — | — | | 11 | n/m | n/m | | 156 | n/m | n/m | | 81 | n/m | n/m |
| Saphnelo | | 474 | 69 | 70 | | 425 | 63 | | 7 | n/m | n/m | | 26 | n/m | n/m | | 16 | 69 | 80 |
| Airsupra | | 66 | n/m | n/m | | 66 | n/m | | — | — | — | | — | — | — | | — | — | — |
| Others | | 400 | (8) | (7) | | 167 | 7 | | 169 | (21) | (20) | | 57 | 5 | 4 | | 7 | (8) | (4) |
| Total Respiratory & Immunology | | 7,416 | 21 | 23 | | 3,416 | 34 | | 1,897 | 7 | 13 | | 1,416 | 22 | 21 | | 687 | 10 | 14 |
| BioPharmaceuticals: Vaccines & Immune Therapies | | | | | | ||||||||||||||
| Synagis | | 447 | (18) | (14) | | (8) | n/m | | 210 | 8 | 17 | | 116 | (34) | (35) | | 129 | (27) | (22) |
| Beyfortus | | 318 | n/m | n/m | | 232 | n/m | | — | n/m | n/m | | 84 | n/m | n/m | | 2 | n/m | n/m |
| FluMist | | 258 | 19 | 15 | | 28 | 19 | | 1 | 28 | 30 | | 204 | 8 | 4 | | 25 | n/m | n/m |
| COVID-19 mAbs | | 31 | (76) | (76) | | 28 | n/m | | — | n/m | n/m | | 3 | (74) | (75) | | — | n/m | n/m |
| Others | | 4 | (68) | (68) | | — | — | | 2 | (82) | (82) | | 2 | 10 | 14 | | — | n/m | n/m |
| Total Vaccines & Immune Therapies | | 1,058 | 5 | 6 | | 280 | n/m | | 213 | 1 | 9 | | 409 | 3 | 1 | | 156 | (47) | (44) |
| Rare Disease: | | | | | | ||||||||||||||
| Ultomiris | | 3,924 | 32 | 34 | | 2,261 | 29 | | 141 | n/m | n/m | | 884 | 32 | 31 | | 638 | 34 | 43 |
| Soliris | | 2,588 | (18) | (14) | | 1,523 | (12) | | 443 | 4 | 34 | | 416 | (38) | (38) | | 206 | (35) | (32) |
| Strensiq | | 1,416 | 23 | 24 | | 1,167 | 25 | | 54 | 33 | 43 | | 99 | 11 | 10 | | 96 | 12 | 18 |
| Koselugo | | 531 | 60 | 66 | | 212 | 9 | | 177 | n/m | n/m | | 103 | 93 | 92 | | 39 | 62 | 73 |
| Kanuma | | 209 | 22 | 24 | | 100 | 17 | | 34 | 19 | 28 | | 66 | 35 | 35 | | 9 | 11 | 15 |
| Total Rare Disease | | 8,668 | 12 | 14 | | 5,263 | 12 | | 849 | 36 | 63 | | 1,568 | 3 | 2 | | 988 | 8 | 15 |
| Other medicines | | | | | | ||||||||||||||
| Nexium | | 867 | (8) | (2) | | 96 | (16) | | 591 | 2 | 11 | | 60 | 13 | 11 | | 120 | (40) | (36) |
| Others | | 206 | (11) | (9) | | 15 | (20) | | 144 | (6) | (4) | | 43 | (17) | (17) | | 4 | (44) | (41) |
| Total Other medicines | | 1,073 | (9) | (4) | | 111 | (17) | | 735 | 1 | 8 | | 103 | (2) | (3) | | 124 | (40) | (36) |
| Total Product Sales | | 50,938 | 16 | 19 | | 21,655 | 21 | | 13,535 | 15 | 23 | | 10,848 | 20 | 19 | | 4,900 | (3) | 3 |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · 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 |
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 240 to 243 of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025.
2024 in brief
Product Sales increased by 16% (CER: 19%) in 2024 to $50,938 million (2023: $43,789 million; 2022: $42,998 million). Growth was well balanced across AstraZeneca's focus therapy areas and key geographies in 2024, driven by strong underlying demand.
Product Sales in the US increased by 21% to $21,655 million (2023: $17,961 million; 2022: $17,254 million) reflecting the continued growth of our Oncology medicines,Ultomiris andSymbicort.
In 2024, Product Sales in Emerging Markets increased by 15% (CER: 23%) to $13,535 million (2023: $11,751 million; 2022: $11,634 million) driven by Oncology and CVRM medicines. China sales, comprising 47% of Emerging Markets sales, increased by 9% (CER: 11%) to $6,402 million (2023: $5,867 million; 2022: $5,740 million). China sales contributed to 13% of Product Sales in 2024.
Ex-China Emerging Markets Product Sales increased by 21% (36% at CER) to $7,133 million (2023: $5,884 million; 2022: $5,894 million) driven by Oncology medicines andFarxiga from CVRM. Among Oncology medicines in Ex-China Emerging Markets, Product Sales ofTagrisso increased by 14% (CER: 30%),Imfinzi increased by 44% (CER: 78%), andLynparza increased by 23% (CER: 37%). Product Sales ofFarxiga in Ex-China Emerging Markets increased by 30% (CER: 40%) to $1,537 million (2023: $1,183 million; 2022: $847 million) in the year.
Product Sales in Europe increased by 20% (CER: 19%) to $10,848 million (2023: $9,029 million; 2022: $8,264 million). Sales of Oncology medicines comprised 38% of Europe Product Sales, which increased in 2024 by 23% (CER: 22%) to $4,082 million (2023: $3,332 million; 2022: $2,726 million) driven by sales ofTagrisso,Imfinzi andLynparza.
Product Sales in the Established ROW region decreased by 3% (CER: increased by 3%) to $4,900 million (2023: $5,048 million; 2022: $5,846 million) largely driven by Oncology medicines. Japan, comprising 71% of total Established ROW Product Sales, decreased by 5% (CER: increased by 3%) to $3,489 million (2023: $3,654 million; 2022: $4,007 million), due to a decline in sales of Oncology medicineImfinzi and Vaccines & Immune Therapies medicineSynagis. Product Sales in Canada, which contributed 19% of total Established ROW Product Sales, decreased by 3% (CER: 2%) to $937 million (2023: $967 million; 2022: $1,165 million).
2023 in brief
Product Sales increased by 2% (CER: 4%) in 2023 to $43,789 million (2022: $42,998 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) 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), 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). 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). 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). 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) in the year. Product Sales of COVID-19 mAbs in Ex-China Emerging Markets decreased by 99% (CER: 99%) to $6 million (2022: $411 million) in the year.
Product Sales in Europe increased by 9% (CER: 7%) to $9,029 million (2022: $8,264 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) 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) largely driven by the decline in Vaccines & Immune Therapies. Japan, comprising 72% of total Established ROW Product Sales, decreased by 9% (CER: 1%) to $3,654 million (2022: $4,007 million), due to the decline in sales of COVID-19 medicines*,* Soliris andNexium. 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).
2022 in brief
Product Sales increased by 18% (CER: 24%) in 2022 to $42,998 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 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. 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. 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. 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. 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 and represented 33% of Europe sales, primarily driven by sales ofTagrisso,Lynparza andImfinzi.Vaxzevria Product Sales contributed $365 million, amounting to 4% of total Europe Product Sales and 20% to the totalVaxzevria Product Sales in 2022. ExcludingVaxzevria, 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 largely driven bySoliris andFarxiga. Japan, comprising 69% of total Established ROW Product Sales, increased by 17% (CER: 39%) to $4,007 million, underpinned by sales ofVaxzevria,Evusheld andNexium. Product Sales in Canada, which contributed 20% of total Established ROW Product Sales, increased by 51% (CER: 57%) to $1,165 million.
Sales by Region in 2024
US
Product Sales in the US increased by 21% to $21,655 million (2023: $17,961 million; 2022: $17,254 million).
Oncology sales in the US increased by 23% to $9,510 million (2023: $7,719 million; 2022: $6,484 million).
Tagrisso sales in the US increased by 21% to $2,763 million (2023: $2,276 million; 2022: $2,007 million). This reflected continued demand growth in both the adjuvant and 1st-line settings and, early launch momentum in Stage III unresectable disease (LAURA), with some additional favourability coming from improved affordability.
Imfinzi sales in the US increased by 20% to $2,603 million (2023: $2,317 million; 2022: $1,552 million), benefitting from continued demand growth driven primarily by HCC and extensive-stage SCLC. The increase also reflected early growth signals from launches in early NSCLC (AEGEAN) and limited-stage SCLC (ADRIATIC).
Calquence sales in the US increased 21% to $2,190 million (2023: $1,815 million; 2022: $1,657 million), as a result of growth driven by a leading share of new patient starts in front-line CLL despite increased competitive pressure, with some additional favourability coming from improved affordability.
Lynparza sales in the US increased by 6% to $1,332 million (2023: $1,254 million; 2022: $1,226 million) as a result of continued leadership within competitive PARP inhibitor class, with demand growth across all indications, with additional favourability coming from improved affordability.
Truqap sales in the US were $408 million (2023: $6 million; 2022: $nil), as a result of strong demand growth with uptake in biomarker altered subgroup of HR+HER2- metastatic breast cancer (CAPItello-291), as well as some benefit due to one-off launch stocking of blister pack.
Imjudo sales in the US increased by 23% to $180 million (2023: $146 million; 2022: $13 million), reflecting continued demand growth.
CVRM
CVRM sales in the US increased by 12% to $3,075 million (2023: $2,752 million; 2022: $2,479 million).
Farxiga sales in the US grew by 21% to $1,750 million (2023: $1,451 million; 2022: $1,071 million), as a result of growth driven by the underlying demand in HFrEF and CKD, as well as the launch of an authorised generic in the first quarter of 2024.
Brilinta sales in the US increased by 1% to $751 million (2023: $744 million; 2022: $744 million).
Crestor sales in the US decreased by 16% to $46 million (2023: $55 million; 2022: $65 million).
Lokelma sales in the US increased by 20% to $256 million (2023: $214 million; 2022: $170 million).
Wainua sales in the US amounted to $85 million (2023: $nil; 2022: $nil), reflecting strong launch momentum.
Andexxa sales in the US increased by 7% to $81 million (2023: $75 million; 2022: $77 million).
Respiratory & Immunology sales in the US increased by 34% to $3,416 million (2023: $2,547 million; 2022: $2,655 million).
Symbicort sales in the US increased by 63% to $1,187 million (2023: $726 million; 2022: $973 million) due to continued strong demand for the authorised generic and a favourable channel mix.
Fasenra sales in the US increased by 6% to $1,049 million (2023: $992 million; 2022: $906 million), benefiting from sustained double-digit volume growth, partially offset by channel mix.
Breztri sales in the US increased by 35% to $516 million (2023: $383 million; 2022: $239 million), following consistent share growth within the expanding FDC triple class.
Saphnelo sales in the US increased by 63% to $425 million (2023: $260 million; 2022: $111 million) as a result of demand acceleration.
Airsupra sales in the US increased to $66 million (2023: $nil; 2022: $nil) as a result of strong launch momentum and volume uptake.
Vaccines & Immune Therapies in the US increased to $280 million (2023: $109 million; 2022: $1,168 million).
Beyfortus sales in the US were $232 million (2023: $87 million; 2022: $nil), as a result of AstraZeneca’s sales of manufacturedBeyfortus product to Sanofi, reflecting increased demand and expanded production capacity.
COVID-19 mAbs sales in the US were $28 million (2023: $nil; 2022: $1,067 million).
Rare Disease sales in the US increased by 12% to $5,263 million (2023: $4,701 million; 2022: $4,324 million).
Ultomiris sales in the US increased by 29% to $2,261 million (2023: $1,750 million; 2022: $1,136 million), as a result of strong growth in patient demand in gMG (CHAMPION-MG) and NMOSD (CHAMPION-NMOSD), both new-to-branded medicines, as well as continued conversion fromSoliris.
Soliris sales in the US decreased by 12% to $1,523 million (2023: $1,734 million; 2022: $2,180 million), driven by successful conversion ofSoliris patients toUltomiris.
Strensiq sales in the US increased by 25% to $1,167 million (2023: $937 million; 2022: $769 million) resulting from strong patient demand.
Koselugo sales in the US increased by 9% to $212 million (2023: $195 million; 2022: $162 million) driven by strong patient demand.
Kanuma sales in the US increased by 17% to $100 million (2023: $85 million; 2022: $77 million).
Other
Other medicines sales in the US decreased by 17% to $111 million (2023: $133 million; 2022: $144 million).
Nexium sales in the US decreased by 16% to $96 million (2023: $115 million; 2022: $120 million) due to generic competition.
Emerging Markets
Product Sales in Emerging Markets increased by 15% (CER: 23%) to $13,535 million (2023: $11,751 million; 2022: $11,634 million).
Oncology sales in Emerging Markets increased by 18% (CER: 28%) to $4,502 million (2023: $3,828 million; 2022: $3,537 million).
Tagrisso sales in Emerging Markets increased by 8% (CER: 16%) to $1,755 million (2023: $1,621 million; 2022: $1,567 million) as a result of encouraging demand growth, partially offset by year-end hospital budget dynamics in China during the fourth quarter of 2024.
Imfinzi sales in Emerging Markets increased by 35% (CER: 59%) to $479 million (2023: $360 million; 2022: $287 million) as a result of strong demand growth driven across all approved indications, in particular BTC.
Calquence sales in Emerging Markets increased by 56% (CER: 79%) to $153 million (2023: $98 million; 2022: $45 million).
Lynparza sales in Emerging Markets increased by 21% (CER: 30%) to $655 million (2023: $542 million; 2022: $488 million), due to volume growth in China from increased share following inclusion of HRD-positive ovarian cancer (PAOLA-1) on NRDL with no price reduction effective 1 January 2024.
Enhertusales in Emerging Markets increased to $350 million (2023: $169 million; 2022: $51 million), as a result of increased demand growth following Q1 2024 launch in HER2-positive and HER2-low metastatic breast cancer in China with some stock compensation in Q4 2024 due to NRDL enlistment.
Zoladex sales in Emerging Markets increased by 16% (CER: 23%) to $795 million (2023: $687 million; 2022: $657 million) driven by strong underlying growth in China.
Orpathys sales in Emerging Markets decreased by 1% (CER: increased by 1%) to $44 million (2023: $44 million; 2022: $33 million), impacted by demand in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations.
CVRM
CVRM sales in Emerging Markets increased by 16% (CER: 22%) to $5,339 million (2023: $4,586 million; 2022: $4,119 million).
Forxiga sales in Emerging Markets increased by 29% (CER: 35%) to $2,853 million (2023: $2,211 million; 2022: $1,665 million) due to increased reimbursement in ex-China Emerging Markets supporting growth despite entry of generic competition in some markets. Q4 2024 sales in China impacted by year end hospital budget dynamics.
Brilinta sales in Emerging Markets increased by 3% (CER: 10%) to $294 million (2023: $285 million; 2022: $286 million) reflecting continued sales growth.
Crestor sales in Emerging Markets increased by 8% (CER: 12%) to $934 million (2023: $862 million; 2022: $794 million), reflecting continued sales growth.
Selokensales in Emerging Markets decreased by 5% (stable at CER) to $589 million (2023: $621 million; 2022: $839 million).
Sales of roxadustat in Emerging Markets increased by 22% (CER: 24%) to $331 million (2023: $271 million; 2022: $197 million), benefitting from continued patient and volume growth.
Sales ofLokelma in Emerging Markets increased by 73% (CER: 79%) to $86 million (2023: $50 million; 2022: $20 million) reflecting strong demand growth.
Respiratory & Immunology sales in Emerging Markets increased by 7% (CER: 13%) to $1,897 million (2023: $1,771 million; 2022: $1,443 million).
Symbicort sales in Emerging Markets increased by 7% (CER: 16%) to $805 million in the year (2023: $753 million; 2022: $608 million), as a result of sustained demand growth across markets in Ex-China regions, partially offset by reduced demand in the fourth quarter in 2024 in China impacted by low rates of respiratory viral infections.
Fasenrasales in Emerging Markets increased by 44% (CER: 55%) to $92 million (2023: $64 million; 2022: $43 million) due to continued strong demand growth driven by launch acceleration across key markets.
Pulmicort sales in Emerging Markets decreased by 1% (CER: increased by 3%) to $568 million (2023: $575 million; 2022: $462 million) largely as a resultof lower seasonal respiratory viral infections in China during the fourth quarter of 2024.
Breztrisales in Emerging Markets increased by 52% (CER: 57%) to $245 million (2023: $161 million; 2022: $92 million) as a result offurther expansion in additional geographies while maintaining market share leadership in China with strong FDC triple class penetration, partially offset by low rates of respiratory viral infections in China in the fourth quarter.
Vaccines & Immune Therapies in Emerging Markets increased by 1% (CER: 9%) to $213 million (2023: $212 million; 2022: $1,316 million).
Synagis sales in Emerging Markets increased by 8% (CER: 17%) to $210 million (2023: $195 million; 2022: $173 million).
Rare Disease sales in Emerging Markets increased by 36% (CER: 63%) to $849 million (2023: $623 million; 2022: $431 million).
Ultomiris sales in the Emerging Markets increased to $141 million (2023: $71 million; 2022: $38 million) as a result of continued growth in patient demand and expansion into new markets.
Soliris sales in the Emerging Markets increased by 4% (CER: 34%) to $443 million (2023: $424 million; 2022: $301 million) as a result of increased patient demand.
Strensiq sales in the Emerging Markets increased by 33% (CER: 43%) to $54 million (2023: $40 million; 2022: $35 million) as a result of favourable timing of tender orders in the fourth quarter.
Koselugo sales in the Emerging Markets increased to $177 million (2023: $59 million; 2022: $26 million), as a result of growing demand following new approvals and reimbursements, as well as the favourable timing of tender orders in the fourth quarter of 2024.
Kanuma sales in the Emerging Markets increased by 19% (CER: 28%) to $34 million (2023: $29 million; 2022: $31 million).
Other
Other medicines sales in Emerging Markets increased by 1% (CER: 8%) to $735 million (2023: $731 million; 2022: $788 million).
Nexium sales in Emerging Markets increased by 2% (CER: 11%) to $591 million (2023: $578 million; 2022: $568 million).
Europe
Product Sales in Europe increased by 20% (CER: 19%) to $10,848 million (2023: $9,029 million; 2022: $8,264 million).
Oncology sales in Europe increased by 23% (CER: 22%) to $4,082 million (2023: $3,332 million; 2022: $2,726 million).
Tagrisso sales in Europe increased by 16% (CER: 15%) to $1,301 million (2023: $1,120 million; 2022: $1,023 million), driven by continued demand growth across adjuvant and 1st-line settings.
Imfinzi sales in Europe increased by 28% (CER: 27%) to $948 million (2023: $758 million; 2022: $544 million), due to growth driven by share gains in extensive-stage SCLC as well as new launches in HCC, BTC and NSCLC.
Calquence sales in Europe increased by 33% (CER: 32%) to $656 million (2023: $493 million; 2022: $286 million) as a result of strong growth in front-line CLL while maintaining share of 1L new patient starts in a competitive environment.
Lynparza sales in Europe increased by 13% (CER: 12%) to $832 million (2023: $734 million; 2022: $655 million), as a result of growth driven by increased market share and additional launches in early breast cancer (OlympiA) and metastatic prostate cancer (PROpel).
Enhertusales in Europe increased to $126 million (2023: $60 million; 2022: $21 million) as a result of continued growth driven by increasing adoption in HER2-positive and HER2-low metastatic breast cancer.
Zoladex sales in Europe increased by 12% (CER: 10%) to $148 million (2023: $133 million; 2022: $133 million).
CVRM
CVRM sales in Europe increased by 31% (CER: 30%) to $3,270 million (2023: $2,503 million; 2022: $1,906 million).
Forxiga sales in Europe increased by 40% (CER: 39%) to $2,634 million (2023: $1,881 million; 2022: $1,297 million) due to continued strong class growth and market share gains.
Brilique sales in Europe decreased by 1% (CER: 2%) to $268 million (2023: $271 million; 2022: $282 million).
Lokelma sales in Europe increased by 59% (CER: 58%) to $92 million (2023: $58 million; 2022: $30 million).
Andexxasales in Europe increased by 30% (CER: 28%) to $80 million (2023: $62 million; 2022: $41 million).
Respiratory & Immunology sales in Europe increased by 22% (CER: 21%) to $1,416 million (2023: $1,164 million; 2022: $1,054 million).
Symbicort sales in Europe increased by 2% (CER: 1%) to $559 million (2023: $549 million; 2022: $582 million) due to continued growth in some markets within mild asthma, partially offset by generic erosion and a slowing overall market.
Fasenra sales in Europe increased by 14% (CER: 13%) to $404 million (2023: $355 million; 2022: $305 million), benefiting from sustained leadership in severe eosinophilic asthma.
Pulmicort sales in Europe increased by 5% (CER: 3%) to $71 million (2023: $68 million; 2022: $69 million).
Tezspire sales in Europe increased to $156 million (2023: $48 million; 2022: $2 million) as a result of achieving and maintaining new-to-brand leadership across multiple markets, while new launches continue to progress.
Trixeo sales in Europe increased by 78% (CER: 77%) to $143 million (2023: $81 million; 2022: $33 million) as a result of sustained growth across markets driven by new launches.
Vaccines & Immune Therapies sales in Europe increased by 3% (CER: 1%) to $409 million (2023: $396 million; 2022: $1,027 million).
Synagissales in Europe decreased by 34% (CER: 35%) to $116 million (2023: $175 million; 2022: $213 million), due to decreased demand following rapid adoption ofBeyfortus.
Beyfortussales in Europe increased to $84 million (2023: $19 million; 2022: $nil) as a result of increased demand.
FluMistsales in Europe increased by 8% (CER: 4%) to $204 million (2023: $188 million; 2022: $151 million) as a result of continued demand growth and an earlier start in the 2024 flu season compared to the prior year.
COVID-19 mAbs sales in Europe decreased to $3 million (2023: $12 million; 2022: $298 million).
Rare Disease sales in Europe increased by 3% (CER: 2%) to $1,568 million (2023: $1,529 million; 2022: $1,428 million).
Ultomiris sales in Europe increased by 32% (CER: 31%) to $884 million (2023: $668 million; 2022: $481 million), as result ofstrong demand growth following recent launches, particularly from neurology indications, and ongoing conversion fromSoliris.
Soliris sales in Europe decreased by 38% (CER: 38%) to $416 million (2023: $670 million; 2022: $805 million) due to decline driven by biosimilar erosion in PNH and aHUS, and continued successful conversion fromSoliris toUltomiris.
Strensiqsales in Europe increased by 11% (CER: 10%) to $99 million (2023: $89 million; 2022: $78 million), as a result of strong patient demand.
Koselugosales in Europe increased by 93% (CER: 92%) to $103 million (2023: $53 million; 2022: $20 million) driven by patient demand.
Kanumasales in Europe increased by 35% (CER: 35%) to $66 million (2023: $49 million; 2022: $44 million), as a result of continued demand growth.
Other
Other medicines sales in Europe decreased by 2% (CER: 3%) to $103 million (2023: $105 million; 2022: $123 million).
Nexium sales in Europe increased by 13% (CER: 11%) to $60 million (2023: $53 million; 2022: $46 million).
Established ROW
Product Sales in the Established ROW region decreased by 3% (CER: increased by 3%) to $4,900 million (2023: $5,048 million; 2022: $5,846 million).
Oncology sales in the Established ROW region decreased by 4% (CER: increased by 2%) to $2,181 million (2023: $2,266 million; 2022: $1,884 million). Oncology sales in Japan decreased by 9% (CER: 2%) to $1,641 million (2023: $1,804 million; 2022: $1,501 million).
Tagrisso sales in the Established ROW region decreased by 3% (CER: increased by 4%) to $761 million (2023: $782 million; 2022: $847 million) due tostrong demand growth in 1st-line settings with year-over-year comparisons reflecting a price reduction in Japan in June 2023. In Japan, sales ofTagrissodecreased by 5% (CER: increased by 3%) to $609 million in the year (2023: $639 million; 2022: $695 million).
Imfinzi sales in the Established ROW region decreased by 8% (CER: 2%) to $687 million (2023: $802 million; 2022: $401 million) as a result of increased demand in GI indications, offset by 25% and 11% mandatory price reductions in Japan effective from 1 February 2024 and 1 August 2024 respectively. In Japan, sales ofImfinzidecreased by 11% (CER: 3%) to $591 million (2023: $714 million; 2022: $329 million).
Calquence sales in the Established ROW region increased by 20% (CER: 22%) to $130 million (2023: $108 million; 2022: $69 million).Calquence sales in Japan increased by 53% (CER: 64%) to $31 million (2023: $20 million; 2022: $7 million).
Lynparza sales in the Established ROW region decreased by 10% (CER: 5%) to $253 million (2023: $281 million; 2022: $269 million) reflecting a 7.7% price reduction in Japan in November 2023 despite maintained PARP class leadership.Lynparza sales in Japan decreased by 16% (CER: 9%) $176 million (2023: $210 million; 2022: $203 million).
Enhertu sales in the Established ROW region increased to $69 million (2023: $32 million; 2022: $7 million).
Zoladex sales in the Established ROW region decreased by 16% (CER: 12%) to $99 million (2023: $118 million; 2022: $122 million) due to reduced uptake in Japan. In Japan,Zoladexsales decreased by 26% (CER: 20%) to $62 million (2023: $83 million, 2022: $107 million).
Imjudosales in the Established ROW region decreased by 5% (CER: increased by 2%) to $49 million (2023: $52 million; 2022: $nil).
CVRM
CVRM sales in the Established ROW region increased by 3% (CER: 9%) to $764 million (2023: $744 million; 2022: $684 million).
Forxiga sales in the Established ROW region was stable (CER: increased by 6%) at $419 million (2023: $420 million; 2022: $348 million) as a result ofcontinued demand growth partially offset by generic competition in Canada. Japan sales increased by 15% (CER: 25%) to $343 million (2023: $298 million; 2022: $215 million).
Crestor sales in the Established ROW region decreased by 2% (CER: increased by 5%) to $136 million (2023: $138 million; 2022: $148 million) with growth in Japan sales of 2% (CER: 10%) to $107 million (2023: $105 million; 2022: $114 million).
Lokelma sales in the Established ROW region increased by 20% (CER: 29%) to $108 million (2023: $90 million; 2022: $69 million) driven by strong demand growth. Sales in Japan increased by 20% (CER: 29%) to $106 million in the year (2023: $88 million; 2022: $67 million).
Andexxa sales in the Established ROW region increased by 22% (CER: 31%) to $55 million (2023: $45 million; 2022: $32 million). Sales in Japan increased by 24% (CER: 33%) to $55 million in the year (2023: $44 million; 2022: $33 million).
Respiratory & Immunology sales in the Established ROW region increased by 10% (CER: 14%) to $687 million (2023: $625 million; 2022: $613 million). Respiratory & Immunology sales in Japan increased by 8% (CER: 17%) to $261 million (2023: $241 million; 2022: $222 million) in the year.
Symbicort sales in the Established ROW region decreased by 2% (stable at CER) to $328 million (2023: $334 million; 2022: $375 million). Sales in Japan decreased by 27% (CER: 21%) to $47 million (2023: $65 million; 2022: $81 million) due to continued generic erosion.
Fasenra sales in the Established ROW region increased by 1% (CER: 6%) to $144 million (2023: $142 million; 2022: $142 million) due to maintaining class leadership in a broadly stable market in Japan. Sales in Japan decreased by 4% (CER: increased by 3%) to $78 million (2023: $82 million; 2022: $88 million) in the year.
Breztri sales in the Established ROW region increased by 41% (CER: 47%) $74 million (2023: $52 million; 2022: $34 million) which is largely due to increased market share in Japan. Sales in Japan increased by 20% (CER: 29%) to $45 million (2023: $37 million; 2022: $31 million).
Tezspire sales in the Established ROW region increased to $81 million (2023: $37 million; 2022: $2 million) driven by sustained market share growth in Japan and other major geographies alongside continued launches. Sales in Japan increased to $63 million (2023: $30 million; 2022: $2 million).
Vaccines & Immune Therapies sales in the Established ROW region decreased by 47% (CER: 44%) to $156 million (2023: $295 million; 2022: $1,225 million). Vaccines & Immune Therapies sales in Japan decreased by 41% (CER: 37%) to $138 million (2023: $234 million; 2022: $756 million) in the year.
Synagis sales in the Established ROW region decreased by 27% (CER: 22%) to $129 million (2023: $177 million; 2022: $191 million) due to rapid adoption ofBeyfortus. Sales in Japan decreased by 23% (CER: 17%) to $116 million (2023: $150 million; 2022: $162 million).
Rare Disease sales in the Established ROW region increased by 8% (CER: 15%) to $988 million (2023: $911 million; 2022: $870 million). Rare Disease sales in Japan increased by 10% (CER: 19%) to $744 million (2023: $675 million; 2022: $578 million).
Ultomiris sales in the Established ROW region increased by 34% (CER: 43%) to $638 million (2023: $476 million; 2022: $310 million) driven by continued conversion fromSoliris and strong demand following new launches. Sales in Japan increased by 24% (CER: 34%) to $548 million (2023: $441 million; 2022: $285 million).
Soliris sales in the Established ROW region decreased by 35% (CER: 32%) to $206 million (2023: $317 million; 2022: $476 million) driven by successful conversion fromSoliris toUltomiris.Soliris sales in Japan decreased by 44% (CER: 39%) to $75 million (2023: $133 million; 2022: $224 million).
Strensiqsales in the Established ROW region increased by 12% (CER: 18%) to $96 million (2023: $86 million; 2022: $76 million) driven by strong patient demand. Sales in Japan increased by 12% (CER: 20%) to $82 million (2023: $74 million; 2022: $66 million).
Koselugosales in the Established ROW region increased by 62% (CER: 73%) to $39 million (2023: $24 million; 2022: $nil) driven by strong patient demand. Sales in Japan increased by 51% (CER: 64%) to $35 million (2023: $23 million; 2022: $nil).
Other
Other medicines sales in the Established ROW region decreased by 40% (CER: 36%) to $124 million (2023: $207 million; 2022: $570 million). Sales in Japan decreased by 48% (CER: 43%) to $82 million (2023: $156 million; 2022: $507 million).
Nexium sales in the Established ROW region decreased by 40% (CER: 36%) to $120 million (2023: $199 million; 2022: $551 million) due to the impact of generic competition. Sales in Japan decreased by 48% (CER: 43%) to $78 million (2023: $150 million; 2022: $497 million).
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 2024, 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, 2024, the Company’s gross revenues and net profits attributable to the above-mentioned Iranian activities were $35 million and $17 million respectively. For the same period, AstraZeneca’s gross revenues and net profits were $54.1 billion and $7.0 billion, respectively. Accordingly, the gross revenues and net profits attributable to the above-mentioned Iranian activities amounted to approximately 0.06% of AstraZeneca’s gross revenues and approximately 0.24% 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” and “—Branches and countries in which the Group conducts business” on page 230 and “Financial Statements—Group Subsidiaries and Holdings” on pages 214 to 218, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 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—2024 compared with 2023”. 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 and Therapy Area Leadership—Operations” on page 41, “Strategic Report—Business Review—Growth and Therapy Area Leadership—Business conduct—Supplier management” on page 43, “Strategic Report—Business Review—Growth and Therapy Area Leadership—IT and IS resources” on page 44, “Financial Statements—Notes to the Group Financial Statements—Note 7—Property, plant and equipment” on page 169, “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 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 is incorporated by reference.
Substantially all of the Group’s properties are held freehold, free of material encumbrances and are fit for their purpose. For more information, please refer to “Financial Statements—Notes to the Group Financial Statements—Note 7—Property, plant and equipment” on page 169 of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025.
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 194 to 201, and “Additional Information—Important information for readers of this Annual Report” on page 244, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 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.B—“Information on the Company—Business Overview—Geographical Review”.
A. Operating Results
2024 compared with 2023
The information set forth under the heading “Strategic Report—Financial Review” on pages 67 to 84 (excluding the information set forth under the subheadings “Full year 2025: additional commentary” and “Currency impact” on page 81) of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 is incorporated herein by reference.
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 the Form 20-F dated February 20, 2024 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 2024” and “—Summary cash flows” on page 77, “Strategic Report—Financial Review—Financial position – 31 December 2024” on pages 79 to 81, “Strategic Report—Financial Review—Capitalisation and shareholder return” on page 81, “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 203 to 212, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 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 36, “Strategic Report—Business Review—Science and Innovation—Sustainable innovation—Intellectual property” on page 37, and “Strategic Report—Business Review—People and Sustainability—Patent protection and access” on page 52, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 is incorporated by reference. Please also see the information above under the headings Item 4.B—“Information on the Company— Business Overview—Development Pipeline as at February 6, 2025” and “—Patent Expiries of Key Marketed Products as at February 6, 2025”.
D. Trend information
The information set forth in the introductory paragraph under the heading “Strategic Report—Financial Review” on page 67 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 page 69, “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 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 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 82, “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 203 to 212, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 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 6 February 2025” on pages 88 to 89, and “Corporate Governance—Directors’ Remuneration Report—Annual Report on Remuneration—Governance—Directors’ service contracts and letters of appointment” on page 136, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 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 6 February 2025” on page 90 of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 is incorporated by reference.
On February 18, 2025, the Company announced that Karen Knudsen, a globally-recognised cancer scientist and executive leader, will be proposed for election as a Non-Executive Director at the Company’s Annual General Meeting on April 11, 2025 (the “2025 AGM”). Karen will become a member of the Science Committee and the Sustainability Committee if elected to the Board. At the same time, the Company also announced that current Non-Executive Directors Deborah DiSanzo and Andreas Rummelt will not stand for re-election and will retire from the Board at the end of the at the 2025 AGM and that the Board has appointed Diana Layfield, Non-Executive Director, as a member of the Remuneration Committee with effect from May 1, 2025.
Senior Executive Team (SET) Biographies as at 6 February 2025
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.
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 – CEO, 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 JCR Pharmaceuticals and Cellectis.
David Fredrickson – Executive Vice-President, Oncology Haematology 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 Haematology 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 United States. 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 United States. 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.
Dave was appointed to the Board of Directors of Caris Life Sciences in August 2024.
Susan Galbraith - Executive Vice-President, Oncology Haematology R&D
Susan was appointed as Executive Vice-President, Oncology R&D in July 2021, with responsibility for transforming the productivity and scientific output from Oncology R&D. Over her career, Susan has helped develop 12 approved medicines. A Clinical Oncologist by background, Susan studied medicine at Manchester and Cambridge Universities and has a PhD from the University of London. In recognition of her contributions to Oncology drug development, she has been awarded an honorary Doctorate of Medical Science from the Institute of Cancer Research (ICR), is a Fellow of the Academy of Medical Sciences and elected to the Academy of the American Association for Cancer Research (AACR). Susan is a member of the Cambridge Cancer Centre Executive Committee and the Scientific Advisory Board of the ICR. From 2021 to 2024 she served on the Board of Directors of the AACR and currently serves on the European Association of Cancer Research (EACR) Advisory Council.
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, International
Iskra was appointed as Executive Vice-President, International in December 2024. She is responsible for overall strategy and driving sustainable growth across the International region, which includes China, Asian and Eurasian markets, Middle East & Africa, Latin America, Australia & New Zealand. Prior to this role, Iskra held the role of EVP, Vaccines & Immune Therapies, where she was responsible for both the early and late-stage development of the Unit’s pipeline and portfolio, including COVID-19 and RSV vaccines and monoclonal antibodies, strategic partnerships and acquisitions, medical affairs and commercial operations. Iskra has served on AstraZeneca’s Senior Executive Team since 2017 when she was EVP for Europe & Canada. She has also held senior roles across Central & Eastern Europe, Middle East and Africa, and Eurasia. Iskra has a PhD in Strategy and Leadership and an International Executive MBA in Business and Leadership from the IEDC-Bled School of Management, Slovenia. She also holds a DMD from the Medical University of Zagreb.
Iskra was appointed as a non-executive director of the Board of Directors of myTomorrows in July 2024. She is also a member of the Steering Committee of the Partnership for Health System Sustainability and Resilience.
B. Compensation
The information (including graphs and tabular data) set forth under the headings “Corporate Governance—Directors’ Remuneration Report” on pages 112 to 115, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—5. Remuneration” on page 93, “Strategic Report—Our Strategy and Key Performance Indicators—Our Key Performance Indicators and remuneration” on page 12, “Financial Statements—Notes to the Group Financial Statements—Note 22—Post-retirement pension and other defined benefit schemes” on pages 184 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 213, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 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 87, “Corporate Governance—Board of Directors as at 6 February 2025” on pages 88 to 89, “Corporate Governance—Senior Executive Team (SET) as at 6 February 2025” on page 90, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—1. Board leadership and Company purpose” on page 91, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—2. Division of responsibilities” on pages 91 to 92, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—5. Remuneration” on page 93, “Corporate Governance—Sustainability Committee Report” on page 103, “Corporate Governance—Compliance with the UK Corporate Governance Code—Further information on risk management and controls—Global Compliance and GIA” on page 93, “Corporate Governance—Nomination and Governance Committee Report” on pages 100 to 101, “Corporate Governance—Science Committee Report” on page 102, “Corporate Governance—Directors’ Remuneration Report—Annual Report on Remuneration—Governance—Directors’ service contracts and letters of appointment” on page 136, “Corporate Governance—Directors’ Remuneration Report—Remuneration at a glance—Looking ahead—Executive Directors’ remuneration for 2025” on page 116, “Corporate Governance—Directors’ Remuneration Report—Annual Report on Remuneration—Executive Directors’ remuneration” on pages 119 to 127, “Corporate Governance—Directors’ Remuneration Report—Annual Report on Remuneration—Non-Executive Directors’ remuneration” on page 128 and “Corporate Governance—Audit Committee Report” on pages 104 to 111, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 is incorporated by reference.
Please also see the information above under the heading Item 6.A—“Directors and Senior Management—Senior Executive Team (SET) Biographies”.
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—Summary and performance indicators” on page 39, “Strategic Report—Business Review—Growth and Therapy Area Leadership—Business conduct” on pages 42 to 43, “Strategic Report—Business Review—Growth and Therapy Area Leadership—Operations” on page 41, “Strategic Report—Business Review—Growth and Therapy Area Leadership—IT and IS resources” on page 44, “Strategic Report—Business Review—Growth and Therapy Area Leadership—Business development” on page 46, “Strategic Report—Business Review—People and Sustainability—Summary and performance indicators” on page 47, “Strategic Report—Business Review—People and Sustainability—People” and “—Talent attraction and retention” on pages 48 to 50 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 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 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, and “Corporate Governance—Directors’ Remuneration Report—Annual Report on Remuneration—Directors’ shareholdings” on pages 129 to 131, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 is incorporated by reference.
Directors’ and SET shareholdings
At January 31, 2025, the total amount of the Company’s voting securities owned by Directors of the Company and SET members was:
| · · · · · | ||
|---|---|---|
| Title of class | Amount owned | Percentage of class |
| Ordinary Shares | 583,895.00 | 0.038% |
Options to purchase securities from registrant or subsidiaries
At January 31, 2025, options outstanding to subscribe for Ordinary Shares were:
| · · · · | ||
|---|---|---|
| Number of shares | Subscription price (pence) | Normal expiry date |
| 1,134,487 | 5833 - 10441 | 2024 - 2030 |
The weighted average subscription price of options outstanding at January 31, 2025 was 8825 pence. All options were granted under Company employee share schemes. None of the options included in the table above have been granted to SET members. During 2024, no options were held by Directors. During the period January 1, 2025 to January 31, 2025, no Director was granted or exercised any options.
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—Directors’ Report—Major shareholdings” (including tabular data) on page 231 of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 is incorporated by reference.
At January 31, 2025, the proportion of Ordinary Shares represented by ADSs was 19.2% of the issued share capital of the Company. At January 31, 2025, there were 63,231 registered holders of Ordinary Shares, of which 595 were based in the United States and there were 1,502 record holders of ADRs, of which 1,484 were based in the United States.
The Company received notification pursuant to the Disclosure Guidance and Transparency Rules (DTR 5) that on the 29 January 2025, The Capital Group Companies, Inc. interest had decreased to 77,477,644 ordinary shares (4.997% of issued share capital), including 15,953,078 ordinary shares represented by ADRs.
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 213, “Additional Information—Shareholder information—Related party transactions” on page 228, “Additional Information—Shareholder information—Issued share capital, shareholdings and share prices” on page 229 and “Additional Information—Directors’ Report—Major shareholdings” on page 231, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 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 228 to 229, “Strategic Report—Financial Review—Dividend and share repurchases” on page 81 and “Additional Information—Directors’ Report—Distributions to shareholders – dividends for 2024” on page 231, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 is incorporated by reference.
Summarized financial information for guarantee of securities of subsidiaries
AstraZeneca Finance LLC (“AstraZeneca Finance”) is the issuer of 1.200% Notes due 2026, 4.800% Notes due 2027, 1.750% Notes due 2028, 4.875% Notes due 2028, 4.850% Notes due 2029, 4.900% Notes due 2030, 2.250% Notes due 2031, 4.900% Notes due 2031, 4.875% Notes due 2033 and 5.000% Notes due 2034 (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 2024 | FY 2023 |
| · · $m · · $m | ||
| Total Revenue | — | — |
| Gross profit | — | — |
| Operating loss | (34) | (34) |
| Loss for the period | (1,182) | (976) |
| Transactions with subsidiaries that are not issuers or guarantors | 1,661 | 15,660 |
Obligor group summarised Statement of Financial Position information
| · · · · | ||
|---|---|---|
| | At 31 Dec 2024 | At 31 Dec 2023 |
| · · $m · · $m | ||
| Current assets | 54 | 5 |
| Non-current assets | — | — |
| Current liabilities | 2,347 | (4,856) |
| Non-current liabilities | 26,603 | (22,239) |
| Amounts due from subsidiaries that are not issuers or guarantors | 18,272 | 18,421 |
| Amounts due to subsidiaries that are not issuers or guarantors | — | — |
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 203 to 212 of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 and is incorporated by reference.
The information set forth in the final paragraph under the heading “Strategic Report—Business Review—Growth and Therapy Area Leadership—Our regions” on page 39 of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 is incorporated by reference.
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 213 of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 and is incorporated by reference.
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 228 to 229 and “Additional Information—Shareholder information—Ordinary Shares in issue” on page 229 of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 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 pages 228 to 229 and “Additional Information—Shareholder information—Issued share capital, shareholdings and share prices” on page 229 of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 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 231 of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 is incorporated by reference. Please also see the information above in the first paragraph under the heading Item 4.A—“Information on the Company—History and Development of the Company”.
C. Material Contracts
D. Exchange Controls
Other than certain economic sanctions, which may be in force from time to time, there are no governmental laws, decrees or regulations in the United Kingdom restricting the import or export of capital or affecting the remittance of dividends, interest or other payments to non-resident holders of Ordinary Shares or ADRs.
Other than certain economic sanctions, which may be in force from time to time, there are no limitations under English law or the Articles on the right of non-resident or foreign owners to be the registered holders of, or to exercise voting rights in relation to, Ordinary Shares or ADRs or to be registered holders of notes or debentures of the Company or its wholly owned subsidiary, AstraZeneca Finance LLC.
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 18, 2025, 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 United States or the United Kingdom 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 United Kingdom 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 United Kingdom for tax purposes will generally not be liable for UK tax on capital gains made on the disposal of their Ordinary Shares or ADRs, unless such Ordinary Shares or ADRs are used, held or acquired in connection with a trade, profession or vocation carried on in the United Kingdom 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 United Kingdom.
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 2024. 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 United States 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 United States 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 United Kingdom, 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 United States and not a national of the United Kingdom); (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 previous UK law, a charge to UK stamp duty or UK stamp duty reserve tax (SDRT) may have arisen on the deposit of Ordinary Shares in connection with the creation of ADRs. Under those rules, the rate of UK stamp duty or SDRT was 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 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 June 29, 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 January 1, 2024. However, the Finance Act, enacted on February 22, 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. The Finance Act 2024 also includes an additional exemption for ‘qualifying listing arrangements’ where securities are transferred (without a change in beneficial ownership) in connection with the listing of such securities on a recognised stock exchange. These measures have had effect in relation to issues and transfers of shares (such as Ordinary Shares) made on or after January 1, 2024. US holders are urged to consult their tax advisors if applicable.
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 stamp duty or 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 18, 2025, may be inspected at the Company’s registered office at 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge CB2 0AA, United Kingdom.
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 81 and “Financial Statements—Notes to the Group Financial Statements—Note 28—Financial risk management objectives and policies” on pages 194 to 201, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 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
In the year ended December 31, 2024, the Company’s American Depositary Receipt (“ADR”) program was administered by Deutsche Bank Trust Company Americas (“DBTCA”), as the depositary. On February 6, 2025, the Company entered into a further amended and restated Deposit Agreement (the “Deposit Agreement”) with JPMorgan Chase Bank, N.A. (“JPMorgan”), as depositary (the “Depositary”), and the holders and beneficial owners of ADRs, which transferred the Company’s ADR program from DBTCA to JPMorgan.
The holder of an ADR may have to pay the following fees and charges to the Depositary 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;●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●fees and expenses incurred by the Depositary in connection with the delivery or servicing of deposited securities●a transaction fee per cancellation request and any applicable delivery expenses | 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, 2024, we agreed that DBTCA could charge an annual fee of $0.03 per ADR in respect of dividends paid by us. As at December 31, 2024, we have been paid approximately $15.9 million arising out of fees charged in respect of dividends paid during 2024 and $0.7 million as a (further) contribution to the Company’s ADR program costs. For the year ended December 31, 2024, we also agreed that DBTCA would 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—Further information on risk management and controls” on page 93, “Corporate Governance—Audit Committee Report—Internal controls” on page 110, and “Financial Statements—Directors’ Annual Report on Internal Controls over Financial Reporting” on page 138, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 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 138 of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025, 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, 2024, has been audited by PricewaterhouseCoopers LLP, independent registered public accounting firm, as stated in its report dated February 6, 2025, 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—Attendance in 2024—Board Committee membership and meeting attendance in 2024” on page 87 and “Corporate Governance—Audit Committee Report—Committee overview—Committee composition” on page 105, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 is incorporated by reference.
ITEM 16B. CODE OF ETHICS
The information set forth under the headings “Strategic Report—Business Review—Growth and Therapy Area Leadership—Business conduct” on pages 42 to 43, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Further information on risk management and controls—Global Compliance and GIA” on page 93, “Strategic Report—Business Review—Science and Innovation—Sustainable innovation” on page 37, and “Corporate Governance—Audit Committee Report—Activities during the year—Legal and Compliance” on page 106, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 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 2024 and 2023:
| · · · · · · | ||||
|---|---|---|---|---|
| · · Year ended December 31, | ||||
| · 2024 · 2023 · 2022 | ||||
| · · ($ million) | ||||
| Audit fees | 29.4 | | 29.1 | 28.7 |
| Audit-related fees | 2.1 | | 0.8 | 0.4 |
| All other fees | 0.3 | | 0.2 | 0.2 |
| Total | 31.8 | | 30.1 | 29.3 |
Audit fees included $14.8 million for the audit of subsidiaries pursuant to legislation (2023: $15.0 million), $10.6 million for the Group audit (2023: $10.2 million), $0.5 million for services in relation to the interim financial statements (2023: $0.6 million) and $3.5 million in respect of section 404 of the Sarbanes-Oxley Act (2023: $3.3 million). Fees payable in the year of $0.2 million (2023: $0.7 million) are in respect of the Group audit and audit of subsidiaries related to prior years.
Audit-related fees included $1.7 million of other audit-related services (2023: $0.5 million) and $0.4 million for the audit of subsidiaries’ pension schemes (2023: $0.3 million).
All other fees of $0.3 million related to other assurance services (2023: $0.2 million).
The information (including tabular data) set forth under the heading “Corporate Governance—Audit Committee Report” on pages 104 to 111 of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 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 2024 and 2023, 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 percent 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
Following a rigorous process, the Company concluded an audit tender for the Company’s external audit provider. On July 25, 2024, the Company announced that the Audit Committee of the Company has recommended, and the Board of Directors has endorsed, the appointment of KPMG LLP (“KPMG”) as the Company’s external auditor for the fiscal year ending December 31, 2026. A resolution will be put to the shareholders at the 2026 Annual General Meeting to approve this appointment. It is intended that PricewaterhouseCoopers LLP (“PwC”), who have been the Company’s independent auditor since the year ended December 31, 2017, will continue as the Company’s auditors for the year ending December 31, 2025 and will be dismissed at the conclusion of the Company’s 2026 Annual General Meeting.
During the fiscal years ended December 31, 2024 and 2023, PwC did not issue any reports on the financial statements of the Company or on the effectiveness of internal control over financial reporting that contained an adverse opinion or a disclaimer of opinion, nor were the auditors’ reports of PwC qualified or modified as to uncertainty, audit scope, or accounting principles. Furthermore, during the fiscal years ended December 31, 2024 and 2023, no “disagreements,” as that term is defined in Item 16F(a)(1)(iv) of Form 20-F and the related instructions to Item 16F of Form 20-F, occurred over any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedures, which disagreements if not resolved to PwC’s satisfaction would have caused it to make reference to the subject matter of the disagreement in connection with reports it issued during such period, or any “reportable event,” as that term is described in Item 16F(a)(1)(v) of Form 20-F.
The Company has provided PwC with a copy of the foregoing disclosure and has requested that they furnish the Company with a letter addressed to the SEC stating whether they agree with the statements contained herein and, if not, stating the respects in which they do not agree. A copy of PwC’s letter is included as exhibit 15.5 to this Form 20-F dated February 18, 2025.
ITEM 16G. CORPORATE GOVERNANCE
The Company is a public limited company incorporated in the United Kingdom admitted to the equity shares (commercial companies) category 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, 2024. 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). |
ITEM 16H. MINE SAFETY DISCLOSURE
ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
ITEM 16J. INSIDER TRADING POLICIES
As part of its Global Policy Framework, the Company hasadopted a written Standard for Dealing in Shares and Securities governing any type of transaction in our securities, including purchases, sales, and other acquisitions and dispositions, by our directors and executive officers, as well as employees and third parties who are in possession of inside information or otherwise restricted from dealing in our securities. The Standard for Dealing in Shares and Securities is designed to promote compliance with applicable insider trading laws, rules and regulations in, inter alia, the United Kingdom, United States and Sweden, and the Nasdaq listing standards. A copy of the Standard for Dealing in Shares and Securities is included as exhibit 11.2 to this Form 20-F dated February 18, 2025.
ITEM 16K. CYBERSECURITY
Risk and Management Strategy
AstraZeneca employs complementary 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 NIST CSF controls is assessed via recurring independent third-party assessments, internal audits, and both enterprise-wide and targeted manufacturing site penetration testing conducted by a leading external partner. The outputs of these activities are represented in detailed cybersecurity operations and performance metrics. The recurring reports address risk and are reviewed by multiple leadership levels with summaries embedded in enterprise risk reporting provided to the Senior Executive Team (SET) 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, and ad hoc monitoring. AstraZeneca hasnot 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. Enterprise risk reporting includes cybersecurity specific content. The Board of Directors’ Audit Committee provides oversight of risks from cybersecurity threats. The SET receives quarterly cybersecurity updates via the enterprise risk function, and via cybersecurity topics included in meeting agendas. 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 defence operations centre 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—Growth and Therapy Area Leadership—IT and IS resources” on page 44, “Strategic Report—Business Review—Growth and Therapy Area Leadership—Cybersecurity and data privacy” on page 45, “Strategic Report—Risk Overview—Cybersecurity risk” on page 64, “Strategic Report—Risk Overview—Principal Risks—Supply chain and business execution risks—Failure in information technology or cybersecurity” on page 65, and “Corporate Governance—Audit Committee Report—Activities during the year—Cybersecurity risk, digital security and information governance” on page 106, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 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 137 to 213 (excluding the information set forth under the subheadings “Independent Auditors’ Report to the Members of AstraZeneca PLC” on pages 139 to 147) and “Financial Statements—Group Financial Record” on page 226, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2024” included as exhibit 15.1 to this Form 20-F dated February 18, 2025 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 2024, 2023 and 2022, 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 2024, 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 2024, 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 2024, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended 31 December 2024 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 2024, 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 2024 amounted to $4,978 million (including $240 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.
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.
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 $35,734 million and other intangibles totalling $771 million (hereafter the intangible assets) at 31 December 2024. 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 2024, the Group recorded net impairment charges of $1,569 million related to product, marketing and distribution rights and net impairment charges of $3 million related to other intangibles.
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 2024 the Group held legal provisions of $859 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. 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 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 matter; (iii) evaluating the reasonableness of management’s assessment regarding whether an adverse outcome is probable and estimated reliably; (iv) inspecting certain external legal documents; (v) evaluating the sufficiency of the Group’s legal provisions and contingent liabilities disclosures; and (vi) where appropriate, considering the scope, preliminary findings and conclusions of investigations with the assistance of professionals with specialised skill and knowledge.
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 2024 the total net tax liability recognised in respect of uncertain tax positions is $1,321 million and the potential for additional liabilities where the possibility of the additional liabilities falling due is more than remote is (a) $422 million related to transfer pricing matters including items under tax audit, and (b) $214 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 post-retirement pension 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 2024 the Group had defined benefit obligations of $6,100 million 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 2024. 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
6 February 2025
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. | |
| 11.2 | | AstraZeneca Insider Trading Policy. |
| | | |
| 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. | |
| 15.5 | | Letter from PricewaterhouseCoopers LLP addressed to the SEC regarded the change of Registrant’s Certifying Accountants disclosure in this Form 20-F. |
| | | |
| 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 2024 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 | |
| February 18, 2025 | ||
|---|---|---|
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.