UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(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 1934 | |
|
|
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:
(Exact name of Registrant as specified in its charter) |
|
(Jurisdiction of incorporation or organization) |
|
(Address of principal executive offices) |
|
Telephone: + Facsimile number: +44 1223 352 858 |
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person) |
Securities registered or to be registered pursuant to Section 12(b) of the Act:
Title of each class | | Trading symbol(s) | | Name of each exchange on which registered |
|
|
| ||
|
| |||
|
| |||
|
| |||
|
| |||
|
| |||
|
| |||
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, 2025 was:
Title of Class | | Number of Shares Outstanding |
Ordinary Shares of 25¢ each: |
| |
Redeemable Preference Shares of £1 each: |
|
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
Yes ☐
Note — Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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):
| 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 | ☐ | ☒ | 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 2025 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 2025” included as exhibit 15.1 to this Form 20-F dated and submitted on February 24, 2026.
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 2025” 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 52, and the tables on pages 53 to 55, 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” and “—Information on websites” on page 228, and “Additional Information—Glossary” on page 227 in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 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 24, 2026. 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 116 to 124 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 does not form part of, and is not incorporated into, this Form 20-F dated February 24, 2026.
PART 1
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Not applicable.
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE
Not applicable.
ITEM 3. KEY INFORMATION
A.Reserved
B.Capitalization and Indebtedness
Not applicable.
C.Reason for the Offer and Use of Proceeds
Not applicable.
3
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 48 and 49 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026, 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 24, 2026, 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. Other risks not listed here could have a significant adverse effect on our financial condition, results of operations and/or reputation.
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 2025 can be found in the “Strategic Report—Therapy Area Review” on pages 12 to 25 of AstraZeneca’s “Annual Report on Form 20-F Information 2025” included as exhibit 15.1 to this form 20-F dated February 24, 2026. 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. | |
Failure to meet regulatory or ethical requirements for medicine development or approval | ||
We are subject to laws and regulations that control our ability to market our pharmaceutical products. Our development programmes must meet many standards to prove our products are safe, effective and of high quality. Health authorities, such as the FDA in the US and the European Medicines Agency in the EU, can refuse to approve our products or require us to conduct additional clinical trials or scientific testing before they will approve them for marketing. Many factors influence health authority decisions to approve or reject a marketing application for a pharmaceutical product. These include advances in science and technology, new laws, regulations and policies, and different standards for evaluating safety and effectiveness. | Delays in regulatory approvals could delay our ability to market our products and may adversely affect our revenue. Also, post-approval requirements, including additional clinical trials, could cause increased costs. We seek to manage these risks, but policymaking by governments and health authorities can be unpredictable and unforeseen circumstances, such as public health emergencies, may strain health authority resources and delay the approval of our products. Following approval, a health authority may require us to conduct additional clinical trials or scientific testing to address concerns raised after patients have used our products in the marketplace. New data may impact a product’s approval status or lead to labelling changes that limit the use of a product. | |
4
D. Risk Factors
continued
Commercialisation risks | | Impact |
Pricing, affordability, access and competitive pressures | ||
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 80 countries in which we have an active presence 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 towards pooled procurement mechanisms beyond emergency countermeasures and essential medicines. | Continued deterioration of, or lack of improvement in, socio-economic conditions could adversely affect supply and/or distribution in affected countries and the ability or willingness of customers to purchase our medicines, putting pressure on price and/or volumes. This could adversely affect our business or results of operations, for example, those 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, we continue to navigate pricing pressures and policy changes including the EU Joint Clinical Assessment (JCA), the US Inflation Reduction Act (IRA) as well as more recent health equalisation initiatives requiring countries to increase their drug spending to support R&D costs, ensuring a more balanced global pharmaceutical landscape. | |
Failures or delays in the quality or execution of the Group’s commercial strategies | ||
Maximising the commercial potential of our new products underpins the success of our strategy and the delivery of our short- and medium-term targets. We may ultimately be unable to achieve commercial success for various reasons, including: > Difficulties in manufacturing sufficient quantities of the product > Any price control measures imposed by governments and healthcare authorities > Patient access to healthcare > Diagnosis rates > Erosion of IP rights > Failure to show a differentiated product profile > Changes in prescribing habits. The ability to successfully carry out business in emerging markets can be more challenging than in established markets. Such challenges may include: > Volatility in economic or political climates > Inadequate protection against crime (including counterfeiting, corruption and fraud) > Inadvertent breaches of local and international law. | Failure to execute our commercial strategies or achieve the level of sales anticipated for a medicine could materially impact our business. Failure to leverage potential opportunities or appropriately manage risks in emerging markets may materially adversely affect our reputation, business or results of operations. | |
5
D. Risk Factors
continued
Supply chain and business execution risks | | Impact |
Failure to maintain supply of compliant, quality medicines | ||
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, pandemics, conflict or political unrest, failure in IT (including cyber-attack)). > 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 and Good Distribution Practices 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. | |
Failure in information technology or cybersecurity | ||
IT systems enable critical business functions which are increasingly dependent on solution provider cybersecurity controls and maturity. High availability and resilient IT systems remain a business imperative, providing our workforce with continuous access to AI tools, collaboration environments, global communications channels, applications and data. In addition to availability and reliability, these systems must comply with provisions specified in cybersecurity, data security, privacy and individual protection laws. We prioritise data protection and access to delivery innovation, business growth, and uninterrupted medicine supply. Data is often characterised as strictly confidential including 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 with increased volume and fuelled by malicious AI use. 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 remains 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, IT, Operational Technology and AI assets 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. | |
6
D. Risk Factors
continued
Failure to collect and manage data and AI in line with legal and regulatory requirements and strategic objectives | ||
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. The 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 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 and impact delivery of our strategic objectives. 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 EU, China and the US. | | Despite taking measures designed to ensure compliance with applicable privacy- and AI-related laws and regulations by our personnel and our third parties, non-compliance may occur. 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. |
Illegal trade in the Group’s medicines | ||
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. | |
7
D. Risk Factors
continued
Reliance on third-party goods and services | ||
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’s 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. | |
Failure of critical processes | ||
Unexpected events including those beyond our control could result in the failure of critical processes within the Group or at third parties on whom we are reliant. Examples of threats include: > Instability including as a result of war or armed conflicts, terrorism, pandemics, riots, unstable governments, civil insurrection or social unrest > Natural disasters and extreme weather events > Cyber threats detailed in the ‘Failure in information technology or cybersecurity’ risk above. | Crystallisation of such threats may heighten other risks, such as 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 an adverse impact on our operations. | |
Failure to attract, develop, engage and retain a diverse, talented and capable workforce | ||
We rely heavily on recruiting and retaining talented employees with a diverse range of skills and capabilities to meet our strategic objectives. 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 so that they can fully exploit the opportunities presented by new technologies will be important for our ongoing success. | 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 have a significant impact on our business. 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. | |
Legal, regulatory and compliance risks | | Impact |
Safety and efficacy of marketed medicines is questioned | ||
Our ability to accurately assess, prior to launch, the eventual safety or efficacy of a new product once in broader clinical use can only be based on data available at that time, which is inherently limited due to relatively short periods of product testing and relatively small clinical study patient samples. Any unforeseen safety concerns or adverse events relating to our products, or failure to comply with laws, rules and regulations relating to provision of appropriate warnings concerning the dangers and risks of our products that result in injuries, could expose us to large product liability claims, settlements and awards, particularly in the US. Adverse publicity relating to the safety of a product, or of other competing products, may increase the risk of product liability claims. | 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. | |
8
D. Risk Factors
continued
Adverse outcome of litigation and/or governmental investigations | ||
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 181 to 190 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026. | | 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. |
IP risks related to our products | ||
| ||
IP protection provides the foundation for continued investment in developing innovative medicines to improve patient health. However, the pharmaceutical industry is experiencing pressure from governments and other healthcare payers to impose limits on IP protections in an effort to manage healthcare costs. Additionally, policymakers are progressively leveraging regulations to expedite the approval of generic drugs and encourage generic drug utilisation. These policies may drive accelerated utilisation of generic alternatives to our products following expiry or loss of our IP rights. We also recognise increasing use of compulsory licensing in some countries in which we operate. We are subject to numerous patent challenges relating to various products or processes and assertions of non-infringement of our patents. A loss in any of these challenges could result in loss of patent protection on the covered product and a risk to the revenue generated by the product. We also face the risk that our products may be found to infringe patents owned or licensed by third parties and 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 181 to 185 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026. | 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. | |
9
D. Risk Factors
continued
Failure to meet our sustainability targets, regulatory requirements and stakeholder expectations with respect to the environment | ||
Environmental issues will become more important as healthcare systems continue to adopt net-zero climate targets and environmental considerations are embedded in the public procurement of medicinal products and devices. Investors, governments and non-governmental organisations will scrutinise our environmental targets and performance. 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 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. | |
Failure to meet regulatory and ethical expectations on commercial practices, including anti-bribery/anti-corruption, anti-fraud and scientific exchanges | ||
There remains an increased global focus on the implementation and enforcement of anti-bribery/anti-corruption and anti-fraud legislation. Three relevant pieces of legislation include the UK Bribery Act, the UK Economic Crime and Corporate Transparency Act and the US Foreign Corrupt Practices Act. Many other countries where we operate are also enforcing their own laws more aggressively and/or adopting tougher new measures. There has also been an increase in cooperation and coordination between regulators across countries with respect to investigation and enforcement. We have been the subject of anti-corruption investigations and there can be no assurance that we will not, from time to time, be subject to informal enquiries and formal investigations from governmental agencies. In the context of our business, governmental officials interact with us in various roles that are important to our operations, such as in the capacity of a regulator, partner or healthcare payer, reimburser or prescriber, among others. To the extent we are the subject of any such pending and material matters, details are included in “Financial Statements—Notes to the Group Financial Statements—Note 30 Commitments, contingent liabilities and contingent assets” on pages 181 to 189 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026. | Despite taking measures to prevent breaches of applicable anti-bribery/anti-corruption and anti-fraud laws by our personnel and associated third parties, breaches may still occur, potentially resulting in the imposition of significant penalties, such as fines, the requirement to comply with monitoring or self-reporting obligations, or debarment or exclusion from government sales or reimbursement programmes, any of which could materially adversely affect our reputation, business or results of operations. | |
Economic and financial risks | Impact | |
Geopolitical and/or macroeconomic volatility disrupts the operation of our global business | ||
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, periods of high inflation, stagflation or large fluctuation in exchange rates 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, alteration 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 limit the incentives to develop innovative medicines resulting in an adverse impact on revenues and profitability. Any escalation in barriers to the global free flow of medicines could increase costs to serve affected markets which may lead to downward pressure on margins. While the introduction of severe sanctions would be unprecedented in relation to medicines, the landscape continues to evolve. It could occur if matters escalate significantly and could impact processes for the manufacture, distribution and 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. | |
10
D. Risk Factors
continued
Failure to achieve strategic plans or meet targets or expectations | ||
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. | |
Failure in internal control, financial reporting or the occurrence of fraud | ||
Effective internal controls assist in the provision of reliable Financial Statements and the detection and prevention of fraud. Testing of internal controls 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 UK’s Economic Crime and Corporate Transparency Act 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 | ||
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, euro, Chinese renminbi, pound sterling, Japanese yen, and Swedish krona. Most of our cash is invested in AAA credit-rated institutional money market funds, fixed income securities issued by government, financial and non-financial entities, and collateralised and non-collateralised bank deposits. Our credit exposure is a mix of US, EU and rest of world default risk across these institutions. We invest in many projects in an effort to develop a successful portfolio of approved products. Our Consolidated Statement of Financial Position therefore contains significant investments in intangible assets, including goodwill. Our ability to realise value on these investments depends on regulatory approvals, market acceptance, competition, and legal developments. Our defined benefit post-retirement obligations (primarily in the UK and Sweden) can materially change in value but are largely backed by assets invested in growth and liability hedging portfolios, which hedge some of the risks inherent in liability valuations. Although we maintain relevant insurance coverage for risks arising within the Group, we may not be able to maintain our insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses. Tax law is complex, leading to the risk of different interpretations. Revenue authorities can make conflicting claims to the profits taxed in individual countries leading to double taxation and the potential for fines and penalties. Tax laws can change following action by international bodies such as the Organisation for Economic Co-operation and Development 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 64 and for details of current tax disputes, see “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments, contingent liabilities and contingent assets—Tax” on pages 189 to 190 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026. Changes in tax regimes could result in a material impact on the Group’s cash tax liabilities and tax charge, resulting in either an increase or a reduction in financial results. |
11
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.
In 2026, the Company terminated its American Depositary Receipt (“ADR”) programme and directly listed all of its Ordinary Shares on the New York Stock Exchange. The effective date of the direct listing of the Ordinary Shares on the New York Stock Exchange was 2 February 2026.
The information (including tabular data) set forth under the headings “Strategic Report—Financial Review—Collaboration Revenue” on page 57, “Strategic Report—Financial Review—Restructuring” on page 59, “Strategic Report—Financial Review—Acquisitions treated as business combinations” and “—Acquisitions treated as asset acquisitions” on page 62, “Strategic Report—Financial Review—Investments, divestments and capital expenditure” on page 63, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—Board leadership and Company purpose” on page 71 and “Additional Information—Important information for readers of this Annual Report—Information on websites” on page 228, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 is incorporated by reference. Additionally, 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 the Form 20-F dated February 18, 2025 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.
12
B. Business Overview
The information (including graphs and tabular data) set forth under the headings “Strategic Report—AstraZeneca at a Glance” on page 2, “Strategic Report—Chair’s Statement” on page 3, “Strategic Report—Chief Executive Officer’s Review” on pages 4 to 5, “Strategic Report—Financial highlights” on page 1, “Strategic Report—Healthcare in a Changing World” on pages 6 to 7, “Strategic Report—Our Purpose, Values and Business Model” on pages 8 to 9, “Strategic Report—Our Strategy and Key Performance Indicators” on pages 10 to 11, “Strategic Report—Therapy Area Review” on pages 12 to 25, “Strategic Report—Business Review” on pages 26 to 46, “Strategic Report—Risk Overview—Managing risk”, “—Emerging risks”, “—Climate risk”, “—Cybersecurity risk” on page 47, “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 73, “Corporate Governance—Corporate Governance Report—Principal Decisions in 2025—Pipeline strengthening transactions” on page 77, “Financial Statements—Notes to the Group Financial Statements—Note 2—Revenue” on page 140 to 141, “Financial Statements—Notes to the Group Financial Statements—Note 7—Segment information” on pages 147 to 148, “Sustainability Statement” on pages 204 to 219, and “Additional Information—Important information for readers of this Annual Report—Statements of competitive position, growth rates and sales” on page 228, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 is incorporated by reference.
For the avoidance of doubt, KPMG’s Independent Sustainability Assurance Report is not included within this Form 20-F and therefore any references to this report (or the related assurance services) are not incorporated in, and do not form part of, this Form 20-F.
13
Development Pipeline as at February 10, 2026
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 | | Additional | | Area Under Investigation |
|
Oncology | | | | ||||
AZD0240 | KRAS G12D armoured TCR-T | solid tumours | |||||
AZD0516 | STEAP2 TOP1i ADC | prostate cancer | |||||
AZD0754 | STEAP2 CAR-T | prostate cancer | |||||
AZD2068 | EGFR/cMET actinium radioconjugate | solid tumours | |||||
AZD2284 | STEAP2 actinium radioconjugate | prostate cancer | |||||
AZD2962 | IRAK4 inhibitor | haematological malignancies | |||||
AZD3632 | MENIN inhibitor | haematological malignancies | |||||
AZD4360 | CLDN18.2 TOP1i ADC | solid tumours | |||||
AZD4512 | CD22 TOP1i ADC | Modular Ph I/II open-label multi-center study | relapsed/refractory B-cell non-Hodgkin lymphoma | ||||
AZD5492 | CD20 TITAN T-cell engager | haematology | |||||
AZD5863 | CLDN18.2/CD3 bispecific antibody | solid tumours | |||||
AZD6621 | STEAP2 T-cell engager | prostate cancer | |||||
AZD6750 | CD8-guided IL2 | solid tumours | |||||
AZD7003 (China) | GPC3 CAR-T | hepatocellular carcinoma/squamous non-small cell lung cancer | |||||
AZD8421 | CDK2 inhibitor | solid tumours | |||||
AZD9750 | AR PROTAC | prostate cancer | |||||
AZD9793 | GPC3 T-cell engager | solid tumours | |||||
NT-112 | KRAS G12D armoured TCR-T | solid tumours | |||||
NT-175 | TP53 R175H armoured TCR-T | solid tumours | |||||
surovatamig | CD19/CD3 T-cell engager | r/r B-cell non-Hodgkin lymphoma | |||||
surovatamig SOUNDTRACK-E | CD19/CD3 T-cell engager | mature B-cell malignancies | |||||
volrustomig + lenvatinib | PD-1/CTLA-4 bispecific mAb + VEGFi | advanced renal cell carcinoma | |||||
volrustomig | PD-1/CTLA-4 bispecific mAb | 1L advanced clear cell renal cell carcinoma | |||||
CVRM | | | |||||
AZD1613 | PAPPA-1 mAb | ADPKD | |||||
AZD1705 | lipid lowering | cardiovascular disease | |||||
AZD3974 | anti-inflammatory and anti-fibrotic mechanism | cirrhosis | |||||
AZD4063 | PLN | R14del dilated cardiomyopathy | |||||
AZD4144 | NLRP3 | cardiorenal disease | |||||
AZD4248 | NNMT inhibitor | cardiorenal disease | |||||
AZD4954 | Lp(a) inhibitor | dyslipidaemia | |||||
Respiratory & Immunology | | | |||||
AZD0120 | CD19/BCMA CAR-T | systemic lupus erythematosus | |||||
AZD0120 | CD19/BCMA CAR-T | autoimmune diseases | |||||
AZD0120 | CD19/BCMA CAR-T | multiple sclerosis | |||||
AZD5492 | CD20 TITAN T-cell engager | systemic lupus erythematosus | |||||
AZD6912 | siRNA | rheumatoid arthritis | |||||
AZD8965 | inhibition of arginase enzyme | idiopathic pulmonary fibrosis | |||||
surovatamig | CD19/CD3 T-cell engager | B-cell driven autoimmune disease | |||||
Rare Disease | |||||||
ALXN2080 | oral factor D inhibitor | healthy volunteers | |||||
ALXN2350 DCMRestore | AAV gene therapy | BAG3-associated dilated cardiomyopathy | |||||
AZD0120 ALACRITY | CD19/BCMA CAR-T | amyloid light-chain amyloidosis | |||||
AZD1390 AGILE | ATM inhibitor | glioblastoma |
14
Phase II
Compound | | Mechanism | | Additional | | Area Under Investigation |
|
Oncology | | | | ||||
AZD0120 | CD19/BCMA CAR-T | multiple myeloma | |||||
AZD0305 | GPRC5D MMAE ADC | relapsed/refractory multiple myeloma | |||||
AZD3470 | PRMT5 inhibitor | cHL (Phase II), solid tumours (Phase I) | classic Hodgkin lymphoma, solid tumours | ||||
AZD9574 | PARP1 inhibitor | advanced solid malignancies | |||||
camizestrant | ngSERD | HR+ HER2- breast cancer | |||||
FPI-2265 | PSMA actinium radioconjugate | (PP) | prostate cancer | ||||
IPH5201 + Imfinzi | CD39 mAb + PD-L1 mAb | (PP) | neoadjuvant/adjuvant NSCLC | ||||
puxitatug samrotecan | B7-H4 TOP1i ADC | solid tumours | |||||
rilvegostomig ARTEMIDE-01 | PD-1/TIGIT bispecific mAb | (PP) | solid tumours | ||||
saruparib | PARP1 inhibitor | solid tumours | |||||
sonesitatug vedotin | CLDN18.2 MMAE ADC | solid tumours | |||||
surovatamig SOUNDTRACK-B | CD19/CD3 T-cell engager | B-cell non-Hodgkin lymphoma | |||||
surovatamig SYRUS | CD19/CD3 T-cell engager | B-cell acute lymphoblastic leukaemia | |||||
tilatamig samrotecan | EGFR/cMET TOP1i ADC | solid tumours | |||||
torvutatug samrotecan (AZD5335) | anti-FRα TOP1i ADC | ovarian cancer, solid tumours | |||||
volrustomig | PD-1/CTLA-4 bispecific mAb | solid tumours | |||||
volrustomig CANTOR | PD-1/CTLA-4 bispecific mAb | colorectal cancer (mCRC) | |||||
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 | | | |||||
AZD2389 | anti-fibrotic mechanism | metabolic dysfunction-associated steatohepatitis | |||||
AZD5462 | RXFP1 agonist | (PP) | heart failure | ||||
AZD6234 | peptide | chronic weight management in overweight or obesity | |||||
AZD9550 + AZD6234 | GLP-1R glucagon dual agonist + selective amylin agonist | obesity | |||||
balcinrenone/dapagliflozin | MR antagonist/modulator + SGLT2 inhibitor | CKD | |||||
elecoglipron (AZD5004) | oral GLP-1 receptor agonist | T2D/chronic weight management | |||||
opemalirsen | podocyte health | nephropathy | |||||
Respiratory & Immunology | | | |||||
atuliflapon | FLAP inhibitor | asthma | |||||
AZD1163 | anti-PAD2/4 bispecific antibody | rheumatoid arthritis | |||||
AZD4604 | inhaled JAK1 inhibitor | asthma | |||||
AZD6793 | IRAK4 inhibitor | COPD | |||||
AZD7798 | humanised monoclonal antibody targets T-cells subset | Crohn’s disease | |||||
AZD8630 | inhaled TSLP FAb | (PP) | asthma | ||||
tozorakimab | IL-33 mAb | asthma | |||||
Vaccines & Immune Therapies | |||||||
AZD0292 | pseudomonas Psl-PcrV bispecific mAb | bronchiectasis | |||||
AZD5148 | anti-clostridioides difficile TcdB mAb | | reduction of C. diff recurrence | ||||
AZD7760 | mAb combination targeting S aureus virulence factors | prevention of Staph aureus infection | |||||
Rare Disease | | | |||||
ALXN1920 | kidney-targeted factor H fusion protein | primary membranous nephropathy | |||||
ALXN2030 CONCORD | siRNA targeting complement C3 | antibody mediated rejection | |||||
ALXN2420 | growth hormone receptor antagonist | acromegaly | |||||
tarperprumig I TRANSCEND | kinase inhibitor | ANCA-associated vasculitis |
15
Phase III/Pivotal Phase II/Registration (listed until launched in all applicable major markets)
Compound | | Mechanism | | Additional | | Area Under | | Data readout/submission |
|
Oncology | | | | | |||||
camizestrant + CDK4/6i SERENA-6 | ngSERD + CDK4/6i | 1L HR+ HER2- ESR1m advanced breast cancer | Accepted | ||||||
camizestrant + palbociclib SERENA-4 | ngSERD + CDK4/6i | 1L HR+ HER2- advanced breast cancer | H2 2026 | ||||||
camizestrant +/- abemaciclib CAMBRIA-2 | ngSERD + CDK4/6i | adjuvant HR+ HER2- early breast cancer | >2027 | ||||||
camizestrant CAMBRIA-1 | ngSERD | adjuvant switch HR+ HER2- early breast cancer | 2027 | ||||||
Imfinzi + Imjudo HIMALAYA | PD-L1 mAb + CTLA-4 mAb | 1L unresectable HCC | Launched | ||||||
Imfinzi +/- oleclumab +/- monalizumab PACIFIC-9 | PD-L1 mAb +/- CD73 mAb +/- NKG2A mAb | (PP) | unresectable stage III NSCLC | H2 2026 | |||||
puxitatug samrotecan Bluestar-Endometrial01 | B7-H4 TOP1i ADC | 2-3L B7-H4+ endometrial cancer | 2027 | ||||||
rilvegostomig + bevacizumab +/- Imjudo ARTEMIDE-HCC01 | PD-1/TIGIT bispecific mAb +VEGFi +/- CTLA-4 mAb | (PP) | 1L HCC | >2027 | |||||
rilvegostomig + CTx ARTEMIDE-Biliary01 | PD-1/TIGIT bispecific mAb + CTx | (PP) | adjuvant biliary tract cancer | >2027 | |||||
rilvegostomig + CTx ARTEMIDE-Lung02 | PD-1/TIGIT bispecific mAb + CTx | (PP) | 1L PD-L1 TC ≥1% SQ NSCLC | >2027 | |||||
rilvegostomig + Enhertu ARTEMIDE-Gastric01 | PD-1/TIGIT bispecific mAb + HER2 TOP1i ADC | (PP) | 1L HER2+ gastric cancer | >2027 | |||||
rilvegostomig ARTEMIDE-Biliary02 | PD-1/TIGIT bispecific mAb | (PP) | metastatic biliary tract cancer | >2027 | |||||
rilvegostomig ARTEMIDE-Lung03 | PD-1/TIGIT bispecific mAb | (PP) | 1L PD-L1 TC ≥1% NSQ NSCLC | >2027 | |||||
rilvegostomig ARTEMIDE-Lung04 | PD-1/TIGIT bispecific mAb | (PP) | 1L PD-L1≥50% NSCLC | >2027 | |||||
saruparib + ADT +/- abiraterone EvoPAR-Prostate02 | PARP1 inhibitor + ADT +/- NHA | localised/locally advanced BRCAm prostate cancer | >2027 | ||||||
saruparib + camizestrant EvoPAR-Breast01 | PARP1 inhibitor + ngSERD | BRCA/PALB2m HR+ HER2- metastatic breast cancer | >2027 | ||||||
saruparib + NHA EvoPAR-Prostate01 | PARP1 inhibitor + NHA | HRRm/non-HRRm mCSPC | >2027 | ||||||
sonesitatug vedotin CLARITY-Gastric01 | CLDN18.2 MMAE ADC | 2L+ CLDN18.2+ gastric cancer | H1 2026 | ||||||
surovatamig SOUNDTRACK-D2 | CD19/CD3 T-cell engager | 1L elderly DLBCL | >2027 | ||||||
surovatamig SOUNDTRACK-F1 | CD19/CD3 T-cell engager | follicular lymphoma | >2027 | ||||||
torvutatug samrotecan (AZD5335) TREVI-OC-01 | anti-FRα TOP1i ADC | ovarian cancer | >2027 | ||||||
volrustomig eVOLVE-Cervical | PD-1/CTLA-4 bispecific mAb | high-risk locally advanced cervical cancer | 2027 | ||||||
volrustomig eVOLVE-HNSCC | PD-1/CTLA-4 bispecific mAb | unresected locally advanced head and neck squamous cell carcinoma | >2027 | ||||||
volrustomig eVOLVE-Lung02 | PD-1/CTLA-4 bispecific mAb | 1L metastatic NSCLC | 2027 | ||||||
volrustomig eVOLVE-Meso | PD-1/CTLA-4 bispecific mAb | 1L unresectable malignant pleural mesothelioma | >2027 | ||||||
volrustomig eVOLVE-Meso | PD-1/CTLA-4 bispecific mAb | 1L unresectable malignant pleural mesothelioma | >2026 | ||||||
CVRM | | | | ||||||
balcinrenone/dapagliflozin | MR antagonist/modulator + SGLT2 inhibitor | heart failure with CKD | 2027 | ||||||
baxdrostat BaxHTN Bax24 BaxAsia | aldosterone synthase inhibitor | hypertension | Accepted | ||||||
baxdrostat BaxPA | aldosterone synthase inhibitor | primary aldosteronism | >2027 | ||||||
baxdrostat/dapagliflozin | aldosterone synthase inhibitor and reversible inhibitor of SGLT2 | CKD | >2027 | ||||||
baxdrostat/dapagliflozin | aldosterone synthase inhibitor and reversible inhibitor of SGLT2 | prevention of heart failure | >2027 | ||||||
laroprovstat AZURE | PCSK9 inhibitor | dyslipidaemia | 2027 | ||||||
Wainua | ligand-conjugated antisense | (PP) | patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) | Launched | |||||
zibotentan/dapagliflozin | endothelin A receptor antagonist/SGLT2 inhibitor | CKD with high proteinuria | 2027 | ||||||
Respiratory & Immunology | | | | | |||||
Saphnelo TULIP 1 & TULIP 2 AZALEA (China) | type I IFN receptor mAb | (PP) | systemic lupus erythematosus | Launched | |||||
Tezspire NAVIGATOR DIRECTION (China) | TSLP mAb | (PP) | severe uncontrolled asthma | Launched | |||||
tozorakimab OBERON TITANIA PROSPERO MIRANDA | IL-33 mAb | chronic obstructive pulmonary disease | H1 2026 | ||||||
tozorakimab TILIA | IL-33 mAb | severe viral lower respiratory tract disease | H2 2026 | ||||||
Vaccines & Immune Therapies | | | |||||||
Kavigale SUPERNOVA | SARS-CoV-2 LAAB | prevention of COVID-19 | Launched | ||||||
Rare Disease | | | | | |||||
anselamimab CARES | fibril-reactive mAb | amyloid light-chain amyloidosis | Accepted | ||||||
cliramitug DepleTTR-CM | transthyretin depleter | (PP) | transthyretin amyloid cardiomyopathy | 2027 | |||||
efzimfotase alfa HICKORY (301), MULBERRY (305), CHESTNUT (303) | next generation TNSALP ERT | hypophosphatasia | H1 2026 | ||||||
eneboparatide CALYPSO | parathyroid hormone receptor 1 | hypoparathyroidism | Q1 2025 | ||||||
gefurulimab PREVAIL | novel anti-C5, dual binding, nanobody | generalised myasthenia gravis | Accepted |
16
Anticipated data timing and submission status is provided for assets in Phase III or beyond. Projects in Phase III unless otherwise noted.
Compound | | Mechanism | | Additional | | Area Under | | Data readout/submission |
|
|---|---|---|---|---|---|---|---|---|---|
Oncology | |||||||||
Calquence + R-CHOP ESCALADE | BTK inhibitor + R-CHOP | 1L DLBCL | 2027 | ||||||
Calquence + venetoclax + obinutuzumab AMPLIFY | BTK inhibitor + BCL-2 inhibitor + anti-CD20 mAb | 1L CLL | Launched | ||||||
Calquence ECHO | BTK inhibitor | (PP) | 1L MCL | Launched | |||||
Datroway + Imfinzi + CTx AVANZAR | TROP2 TOP1i ADC + PD-L1 mAb + CTx | (PP) | 1L NSQ/NSQ TROP2+ NSCLC | H2 2026 | |||||
Datroway + Imfinzi TROPION-Breast04 | TROP2 TOP1i ADC + PD-L1 mAb | (PP) | neo/adjuvant TNBC or HR-low/HER2- breast cancer | >2027 | |||||
Datroway + Imfinzi TROPION-Breast05 | TROP2 TOP1i ADC + PD-L1 mAb | (PP) | 1L PD-L1 CPS ≥10 TNBC | 2027 | |||||
Datroway + pembrolizumab TROPION-Lung07 | TROP2 TOP1i ADC + PD-1 mAb | (PP) | 1L PD-L1 <50% NSQ NSCLC | H2 2026 | |||||
Datroway + pembrolizumab TROPION-Lung08 | TROP2 TOP1i ADC + PD-1 mAb | (PP) | 1L PD-L1 TPS ≥50% NSQ NSCLC | H2 2026 | |||||
Datroway + rilvegostomig TROPION-Lung10 | TROP2 TOP1i ADC + PD-1/TIGIT bispecific mAb | (PP) | 1L PD-L1 ≥50% NSQ NSCLC | >2027 | |||||
Datroway + Tagrisso TROPION-Lung14 | TROP2 TOP1i ADC + EGFR TKI | (PP) | 1L EGFRm NSCLC | >2027 | |||||
Datroway + Tagrisso TROPION-Lung15 | TROP2 TOP1i ADC + EGFR TKI | (PP) | 2L EGFRm NSCLC | H2 2026 | |||||
Datroway +/- Imfinzi TROPION-Breast03 | TROP2 TOP1i ADC +/- PD-L1 mAb | (PP) | post-neoadjuvant TNBC with residual disease | 2027 | |||||
Datroway TROPION-Breast02 | TROP2 TOP1i ADC | (PP) | 1L TNBC not candidates for IO | Accepted | |||||
Datroway TROPION-Lung05 | TROP2 TOP1i ADC | (PP) | advanced or metastatic EGFRm NSCLC progressed on prior systemic therapies including TKIs and platinum-based chemotherapy | Launched | |||||
Enhertu (platform) DESTINY-Breast07 | HER2 TOP1i ADC | (PP) Phase II LCM | HER2+ breast cancer | ||||||
Enhertu + rilvegostomig DESTINY-BTC01 | HER2 TOP1i ADC + PD-1/TIGIT bispecific mAb | (PP) | 1L HER2+ biliary tract cancer | >2027 | |||||
Enhertu + rilvegostomig/ pembrolizumab DESTINY-Endometrial01 | HER2 TOP1i ADC + PD-1/TIGIT bispecific mAb/PD-1 mAb | (PP) | 1L HER2+ pMMR endometrial cancer | >2027 | |||||
Enhertu + pertuzumab DESTINY-Breast09 | HER2 TOP1i ADC | (PP) | 1L HER2+ breast cancer | Launched | |||||
Enhertu DESTINY-Breast05 | HER2 TOP1i ADC | (PP) | post-neoadjuvant high-risk HER2+ early breast cancer | Q3 2025 | |||||
Enhertu DESTINY-Breast06 | HER2 TOP1i ADC | (PP) | post-ET HR+ HER2-low/ultralow breast cancer | Launched | |||||
Enhertu DESTINY-Endometrial02 | HER2 TOP1i ADC | (PP) | adjuvant endometrial cancer | >2027 | |||||
Enhertu DESTINY-Gastric04 | HER2 TOP1i ADC | (PP) | 2L HER2+ gastric cancer | Launched | |||||
Enhertu DESTINY-Lung04 | HER2 TOP1i ADC | (PP) | 1L HER2m NSCLC | H1 2026 | |||||
Enhertu DESTINY-PanTumor03 (China) | HER2 TOP1i ADC | (PP) Phase II LCM | HER2 expressing solid tumours | ||||||
Enhertu followed by THP DESTINY-Breast11 | HER2 TOP1i ADC | (PP) | neoadjuvant high-risk HER2+ early breast cancer | Accepted | |||||
Enhertu DESTINY-PanTumor01 | HER2 TOP1i ADC | (PP) Phase II LCM | HER2m solid tumours | ||||||
Enhertu DESTINY-PanTumor02 | HER2 TOP1i ADC | (PP) Phase II LCM | HER2 expressing solid tumours | Launched | |||||
Imfinzi + BCG POTOMAC | PD-L1 mAb + BCG | non-muscle invasive bladder cancer | Accepted | ||||||
Imfinzi + CRT KUNLUN | PD-L1 mAb + CRT | locally advanced ESCC | H2 2026 | ||||||
Imfinzi + CRT PACIFIC-5 (China) | PD-L1 mAb + CRT | (PP) | locally advanced stage III NSCLC | Launched | |||||
Imfinzi + CTx +/- Lynparza DUO-E | PD-L1 mAb + CTx +/- PARP inhibitor | (PP) | 1L endometrial cancer | Launched | |||||
Imfinzi + CTx NIAGARA | PD-L1 mAb + CTx | muscle invasive bladder cancer (cis-eligible) | Launched | ||||||
Imfinzi + domvanalimab following cCRT PACIFIC-8 | PD-L1 mAb + TIGIT following cCRT | (PP) | unresectable stage III NSCLC | >2027 | |||||
Imfinzi + EV +/- Imjudo VOLGA | PD-L1 mAb + nectin-4 targeting MMAE ADC +/- CTLA-4 mAb | muscle invasive bladder cancer (cis-ineligible/refusal) | H1 2026 | ||||||
Imfinzi + FLOT MATTERHORN | PD-L1 mAb + CTx | (PP) | resectable early gastric cancer | Launched | |||||
Imfinzi + Imjudo + SoC NILE | PD-L1 mAb + CTLA-4 mAb + SoC | 1L urothelial cancer | H1 2026 | ||||||
Imfinzi + Imjudo + TACE +/- lenvatinib EMERALD-3 | PD-L1 mAb + CTLA-4 mAb +/- chemoembolisation +VEGFi | locoregional HCC | H1 2026 | ||||||
Imfinzi + SBRT PACIFIC-4 | PD-L1 mAb + SBRT | (PP) | stage I/II NSCLC | >2027 | |||||
Imfinzi + VEGF + TACE EMERALD-1 | PD-L1 mAb +VEGFi +TACE | locoregional HCC | Q4 2023 | ||||||
Imfinzi +/- bevacizumab EMERALD-2 | PD-L1 mAb +/- VEGFi | adjuvant HCC | H2 2026 | ||||||
Imfinzi +/- Imjudo + CTx POSEIDON | PD-L1 mAb +/- CTLA-4 mAb + CTx | 1L NSCLC | Launched | ||||||
Imfinzi combinations BEGONIA | PD-L1 mAb + paclitaxel/novel oncology therapies | Phase II LCM | 1L TNBC | ||||||
Imfinzi combinations HUDSON | PD-L1 mAb + novel oncology therapies | Phase II LCM | post-IO NSCLC | ||||||
Imfinzi combinations NeoCOAST-2 | PD-L1 mAb + novel oncology therapies | (PP) Phase II LCM | resectable NSCLC | ||||||
Lynparza MONO-OLA1 | PARP inhibitor | (PP) | 1L BRCAwt ovarian cancer | H2 2026 | |||||
Orpathys + Imfinzi SAMETA | METi + PD-L1 mAb | (PP) | 1L papillary renal cell carcinoma | H1 2026 | |||||
Tagrisso + Orpathys SAFFRON | EGFR TKI +METi | (PP) | advanced EGFRm NSCLC | H2 2026 | |||||
Tagrisso + Orpathys SAVANNAH | EGFR TKI +METi | (PP) Phase II LCM | advanced EGFRm NSCLC | ||||||
Tagrisso +/- CTx NeoADAURA | EGFR TKI +/- CTx | neoadjuvant stage II/III resectable EGFRm NSCLC | Q4 2024 | ||||||
Tagrisso ADAURA2 | EGFR TKI | EGFRm NSCLC stage Ia2-Ia3 following complete tumour resection | 2027 | ||||||
Tagrisso combinations ORCHARD | EGFR TKI + multiple novel ONC therapies | (PP) Phase II LCM | 2L EGFRm osimertinib-resistant NSCLC | ||||||
Truqap | AKT inhibitor | Phase II LCM | prostate cancer | ||||||
Truqap + abiraterone CAPItello-281 | AKT inhibitor + NHA | PTEN deficient mHSPC | Accepted | ||||||
Truqap + Faslodex + palbociclib CAPItello-292 | AKT inhibitor + SERD + CDK4/6i | 1L early relapse/ET resistant advanced HR+ breast cancer | 2027 | ||||||
CVRM | |||||||||
Wainua | ligand-conjugated antisense | (PP) | patients with hereditary or wild-type transthyretin-mediated amyloid cardiomyopathy (ATTR CM) | H2 2026 |
17
Compound | | Mechanism | | Additional | | Area Under | | Data readout/submission |
|
|---|---|---|---|---|---|---|---|---|---|
Respiratory & Immunology | |||||||||
Breztri/Trixeo (PT010) KALOS LOGOS | LABA/LAMA/ICS | asthma | Accepted | ||||||
Breztri/Trixeo ATHLOS | LABA/LAMA/ICS | COPD cardiopulmonary exercise test (CPET) trial | H1 2026 | ||||||
Breztri/Trixeo THARROS | LABA/LAMA/ICS | (PP) | cardiopulmonary outcomes trial in COPD | >2027 | |||||
Fasenra MANDARA | IL-5R mAb | eosinophilic granulomatosis with polyangiitis | Launched | ||||||
Fasenra NATRON | IL-5R mAb | hypereosinophilic syndrome | Accepted | ||||||
Saphnelo DAISY | type I IFN receptor mAb | (PP) | systemic sclerosis | 2027 | |||||
Saphnelo IRIS | type I IFN receptor mAb | (PP) | lupus nephritis | 2027 | |||||
Saphnelo JASMINE | type I IFN receptor mAb | (PP) | myositis | 2027 | |||||
Saphnelo LAVENDER | type I IFN receptor mAb | (PP) | cutaneous lupus erythematosus | 2027 | |||||
Saphnelo TULIP-SC | type I IFN receptor mAb | (PP) | systemic lupus erythematosus (subcutaneous) | Launched | |||||
Tezspire CROSSING | TSLP mAb | (PP) | eosinophilic esophagitis | H2 2026 | |||||
Tezspire EMBARK, JOURNEY | TSLP mAb | (PP) | chronic obstructive pulmonary disease | >2027 | |||||
Tezspire WAYPOINT | TSLP mAb | (PP) | nasal polyps | Launched | |||||
Rare Disease | |||||||||
Koselugo KOMET | MEK inhibitor | (PP) | neurofibromatosis type 1 adult | Launched | |||||
Ultomiris | anti-complement C5 mAb | haematopoietic stem cell transplant– associated thrombotic microangiopathy | H1 2026 | ||||||
Ultomiris ARTEMIS | anti-complement C5 mAb | cardiac surgery-associated acute kidney injury | H2 2026 | ||||||
Ultomiris AWAKE | anti-complement C5 mAb | delayed graft function | >2027 | ||||||
Ultomiris I CAN | anti-complement C5 mAb | immunoglobulin A nephropathy | H1 2026 |
18
Patent Expiries of Key Marketed Products as at February 10, 2026
Patents covering our products are routinely 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 181 to 183 and of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026, 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.
Aggregate Product | ||||||||||||||||||||||
US | Sales Ex-US | |||||||||||||||||||||
Product Sales $m | $m | |||||||||||||||||||||
Key marketed products | | Description | | US | | China | | EU1 | | Japan | | 2025 | | 2024 | | 2023 | | 2025 | | 2024 | | 2023 |
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, 20352-2036 | 2037, 2036 |
| 2,339 |
| 2,190 |
| 1,815 |
| 1,179 |
| 939 |
| 699 | |
Datroway 3 (datopotamab deruxtecan) |
| A TROP2-directed antibody drug conjugate (ADC) indicated for patients with previously treated metastatic HR-positive, HER2-negative breast cancer and for patients with previously treated advanced epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). |
| 2034 |
| 2034 | 2034 |
| 4 | — | — |
| — |
| 2 |
| — |
| — | |||
Enhertu 5 (trastuzumab deruxtecan) |
| A HER2-directed ADC indicated for HER2- positive, HER2-low and HER2-ultralow advanced breast cancers, for HER2- mutant metastatic NSCLC, and for HER2-positive advanced gastric cancer. Also indicated for metastic HER2-positive solid tumours (tumour agnostic). |
| 2033, 2035 |
| 2033-2035 |
| 2033-2035 |
| 4 | — |
| — |
| — | 977 |
| 545 |
| 261 | ||
Imfinzi (durvalumab) |
| A human monoclonal antibody (mAb) that blocks PD-1 and CD80 on T-cells indicated for unresectable, Stage III NSCLC; resectable NSCLC in combination with neoadjuvant chemotherapy; metastatic NSCLC in combination with Imjudo and chemotherapy; extensive-stage small cell lung cancer (SCLC) in combination with chemotherapy; limited-stage SCLC; advanced biliary tract cancer (BTC) in combination with chemotherapy; unresectable hepatocellular carcinoma (uHCC) in combination with Imjudo; in a perioperative regimen with FLOT chemotherapy in resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers; endometrial cancer in combination with Lynparza and chemotherapy; and for muscle-invasive bladder cancer (MIBC). |
| 2031 |
| 2030 |
| 2030 |
| 2033 |
| 3,509 |
| 2,603 |
| 2,171 |
| 2,554 |
| 2,114 |
| 1,848 |
Imjudo 6 (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. | 2034 | 2026 | 2026 | 2031 | 227 | 180 | 146 | 119 | 101 | 72 | |||||||||||
Lynparza 7 (olaparib) | An oral poly (ADP-ribose) polymerase (PARP) inhibitor indicated for platinum-sensitive relapsed ovarian cancer, for 1st-line 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), for 1st-line mCRPC in combination with abiraterone, and as maintenance treatment after treatment with platinum-based chemotherapy in combination with Imfinzi in advanced or recurrent mismatch repair proficient (pMMR) endometrial cancer. | 2027, 2027-2041 | 2027-2029 | 2029, 2027-2029 | 2029, 2027-2034 | 1,434 | 1,332 | 1,254 | 1,845 | 1,740 | 1,557 | |||||||||||
Tagrisso (osimertinib) | An EGFR-TKI indicated for early- and late-stage EGFRm NSCLC. | 2032, 2035 | 20328, 2035 | 8 | 2032, 2035 | 2034, 2035 | 3,064 | 2,763 | 2,276 | 4,190 | 3,817 | 3,523 | ||||||||||
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 | 2033 | 586 | 408 | 6 | 142 | 22 | — | |||||||||||
CVRM |
|
|
|
|
|
|
|
|
|
|
| |||||||||||
Brilinta/Brilique (ticagrelor) |
| An oral P2Y12 platelet inhibitor for acute coronary syndromes (ACS) (ticagrelor 90mg) or continuation therapy in high-risk patients (ticagrelor 60mg) with a history of myocardial infarction (MI). An oral P2Y12 platelet inhibitor for the prevention of atherothrombotic events in adult patients with ACS or high-risk patients with history of MI, high-risk patients with coronary artery disease or stroke. |
| 2025, 2030-2036 |
| 2037 |
| 2025, 2037 |
| 2025-2030 |
| 393 |
| 751 |
| 744 |
| 430 |
| 582 |
| 580 |
Farxiga/Forxiga9 (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 US to improve glycaemic control in paediatric patients with T2D aged 10 years and older. | 2026, 2025-2041 | 20278, 20288, 20408, 2041 | 2028, 2027, 20282, 2041 | 2025, 2028-2040 | 1,730 | 1,750 | 1,451 | 6,670 | 5,906 | 4,512 | |||||||||||
Xigduo/ Xigduo XR 10 (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, 2027-2031 | 2027, 2030 | 2028, 20272, 2030 | 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 | 8 | 2032 |
| 2035-2037 |
| 301 |
| 256 |
| 214 |
| 397 |
| 286 |
| 198 |
Roxadustat 11 |
| An oral hypoxia-inducible factor prolyl hydroxylase inhibitor indicated for the treatment of anaemia from CKD. |
| 4 | 2033 | 8 | 4 | 4 | — |
| — |
| — |
| 274 |
| 331 |
| 271 | |||
Wainua/ Wainzua (eplontersen) | Wainua injection, for subcutaneous use, is a prescription medicine used to treat adults with stage one or two polyneuropathy of hereditary transthyretin-mediated amyloidosis. | 2025-2034 | 2034-2035 | 2034 | 2034 | 204 | 85 | — | 8 | — | — | |||||||||||
19
Aggregate Product | ||||||||||||||||||||||
US | Sales Ex-US | |||||||||||||||||||||
Product Sales ($m) | ($m) | |||||||||||||||||||||
Key marketed products | | Description | | US | | China | | EU1 | | Japan | | 2025 | | 2024 | | 2023 | | 2025 | | 2024 | | 2023 |
Respiratory & Immunology | ||||||||||||||||||||||
Airsupra (albuterol/ budesonide) |
| A first-in-class, fixed-dose combination rescue medication for asthma in the US containing a short-acting beta2-agonist (SABA) and an anti-inflammatory inhaled corticosteroid (ICS), for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations, developed in a pressurised metered-dose inhaler (pMDI) using AstraZeneca’s Aerosphere delivery technology. |
| 2030 |
| 2030 |
| 2030 |
| 162 |
| 66 |
| — | 4 |
| — |
| — | |||
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 Aerosphere pMDI, used for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). |
| 2030-2038 |
| 2030-2038 | 2030-2038 | 2030-2038 |
| 614 |
| 516 |
| 383 |
| 585 |
| 462 |
| 294 | ||
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). |
| 2028-2034 |
| 2028 |
| 2025, 2028-2034 | 2025, 2034 | 1,195 |
| 1,049 |
| 992 |
| 786 |
| 640 |
| 561 | ||
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 2036-2042 | 2 | 2030-2034, 2033-2036 |
| 596 |
| 425 |
| 260 |
| 90 |
| 49 |
| 20 |
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 | 12 | expired |
| expired | expired | 1,193 |
| 1,187 |
| 726 |
| 1,692 |
| 1,692 |
| 1,636 | ||
Tezspire 13 (tezepelumab) |
| A first-in-class human mAb that inhibits the action of thymic stomal lymphopoietin, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and other types of epithelial inflammation associated with severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP). Approved for a broad population of severe asthma patients, without phenotype and biomarker limitation, and for CRSwNP. Developed in collaboration with Amgen Inc. (Amgen). |
| 203314, 2038 |
| 2028 |
| 2028 | 2028, 2038 | — |
| — |
| — |
| 458 |
| 248 |
| 86 | ||
Vaccines & Immune Therapies |
|
|
|
|
|
|
|
|
|
| ||||||||||||
Beyfortus 15 (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 |
| 184 |
| 232 |
| 87 |
| 97 |
| 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 | 16 | 28 | 28 | 23 | 244 | 230 | 193 | ||||||||||
20
Aggregate Product | ||||||||||||||||||||||
US | Sales Ex-US | |||||||||||||||||||||
Product Sales ($m) | ($m) | |||||||||||||||||||||
Key marketed products | | Description | | US | | China | | EU1 | | Japan | | 2025 | | 2024 | | 2023 | | 2025 | | 2024 | | 2023 |
Rare Disease |
| |||||||||||||||||||||
Koselugo 17 (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, 2026-2029 | 2026-2029 | 2029-2031 | 2029-2031 | 219 | 212 | 195 | 443 | 319 | 136 | |||||||||||
Soliris (eculizumab) | A 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). | 202718, 2025-2032 | 2029 | 202719, 2029 | 2032, 2029 | 1,092 | 1,523 | 1,734 | 745 | 1,065 | 1,411 | |||||||||||
Strensiq (asfotase alfa) |
| A targeted enzyme replacement therapy for patients with hypophosphatasia. |
| 2025-2029, 2035-2038 |
| 2025-2031, 2036 |
| 2028, 2035-2036 | 1,332 |
| 1,167 |
| 937 |
| 346 |
| 249 |
| 215 | |||
Ultomiris (ravulizumab) | A long-acting C5 complement inhibitor for the treatment of PNH, aHUS, gMG and NMOSD. | 2035, 2038-2041 | 2035, 2038 | 2035, 2038-2040 | 2038, 2038-2039 | 2,667 | 2,261 | 1,750 | 2,051 | 1,663 | 1,251 | |||||||||||
Voydeya 20 (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 Zoladex are key marketed products which have lost patent protection in all major markets.
| 1 | Expiry in major EU markets, which includes the UK. |
| 2 | The patent is the subject of a pending opposition proceeding at the European Patent Office (EPO). |
| 3 | AstraZeneca does not have commercialisation rights. |
| 4 | AstraZeneca has recorded $77 million of Alliance Revenue in relation to Datroway in 2025 (2024: $nil; 2023: $nil), as per the “Financial Statements—Notes to the Group Financial Statements—Note 2—Revenue” on pages 140 to 141 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026. |
| 5 | AstraZeneca has recorded $1,798 million of Alliance Revenue in relation to Enhertu in 2025 (2024: $1,437 million; 2023: $1,022 million), as per the “Financial Statements—Notes to the Group Financial Statements—Note 2—Revenue” on pages 140 to 141 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026. |
| 6 | Prior to 2024, Imjudo Product Sales were included in the Imfinzi Product Sales figure within the “Financial Statements—Notes to the Group Financial Statements—Note 2—Revenue” on pages 140 to 141 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026. |
| 7 | In addition to any Product Sales, AstraZeneca has also recorded $nil of Collaboration Revenue in relation to Lynparza in 2025 (2024: $600 million; 2023: $245 million), as per the “Financial Statements—Notes to the Group Financial Statements—Note 2—Revenue” on pages 140 to 141 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026. |
| 8 | The patent is the subject of one or more proceedings on its validity. |
| 9 | AstraZeneca has recorded $87 million of Collaboration Revenue in relation to Farxiga/Forxiga in 2025 (2024: $56 million; 2023: $29 million), as per the “Financial Statements—Notes to the Group Financial Statements—Note 2—Revenue” on pages 140 to 141 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026. |
| 10 | Xigduo/Xigduo XR revenues are combined with Farxiga/Forxiga. |
| 11 | AstraZeneca has recorded $2 million of Alliance Revenue in relation to roxadustat in 2025 (2024: $6 million; 2023: $5 million), as per the “Financial Statements—Notes to the Group Financial Statements—Note 2—Revenue” on pages 140 to 141 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026. |
| 12 | Patent expiry information relates to the Symbicort pMDI product, including any granted Paediatric Exclusivity term. |
| 13 | AstraZeneca has recorded $673 million of Alliance Revenue in relation to Tezspire in 2025 (2024: $436 million; 2023: $259 million), as per the “Financial Statements—Notes to the Group Financial Statements—Note 2—Revenue” on pages 140 to 141 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026. |
| 14 | Date does not include patent term adjustment. |
| 15 | AstraZeneca has recorded $422 million of Alliance Revenue in relation to Beyfortus in 2025 (2024: $237 million; 2023: $57 million) and $nil of Collaboration Revenue in 2025 (2024: $167 million; 2023: $98 million), as per the “Financial Statements—Notes to the Group Financial Statements—Note 2—Revenue” on pages 140 to 141 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026. |
| 16 | Rights licensed to Daiichi Sankyo, Inc. |
| 17 | In addition to any Product Sales, AstraZeneca has also recorded $nil of Collaboration Revenue in relation to Koselugo in 2025 (2024: $100 million; 2023: $nil), as per the “Financial Statements—Notes to the Group Financial Statements—Note 2—Revenue” on pages 140 to 141 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026. |
| 18 | Settled with Amgen and Samsung Bioepis for licensed biosimilar entry date of 1 March 2025. |
| 19 | Settled with Amgen for licensed biosimilar entry date of November 2025. |
| 20 | Voydeya revenues are combined with Ultomiris. |
21
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 | |||||||||||||
2025 | $m | | % | | % | | $m | | % | | $m | | % | | % | | $m | | % | | % | | $m | | % | | % | |
Oncology: |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
Tagrisso |
| 7,254 | 10 | 10 | 3,064 | 11 | 1,971 | 12 | 14 | 1,423 | 9 | 6 | 796 | 5 | 5 | |||||||||||||
Imfinzi |
| 6,063 | 29 | 28 | 3,509 | 35 | 640 | 34 | 38 | 1,239 | 31 | 26 | 675 | (2) | (2) | |||||||||||||
Calquence |
| 3,518 | 12 | 12 | 2,339 | 7 | 233 | 52 | 54 | 784 | 20 | 15 | 162 | 25 | 27 | |||||||||||||
Lynparza |
| 3,279 | 7 | 6 | 1,434 | 8 | 669 | 2 | 1 | 914 | 10 | 6 | 262 | 3 | 4 | |||||||||||||
Enhertu |
| 977 | 79 | 81 | — | — | 668 | 91 | 95 | 207 | 64 | 58 | 102 | 47 | 51 | |||||||||||||
Zoladex | 1,106 | 5 | 6 | 19 | 17 | 842 | 6 | 8 | 157 | 6 | 3 | 88 | (11) | (10) | ||||||||||||||
Truqap |
| 728 | 69 | 68 | 586 | 44 | 23 | n/m | n/m | 85 | n/m | n/m | 34 | n/m | n/m | |||||||||||||
Imjudo |
| 346 | 23 | 23 | 227 | 26 | 22 | 40 | 43 | 52 | 43 | 38 | 45 | (9) | (9) | |||||||||||||
Datroway |
| 2 | n/m | n/m | — | n/m | 2 | n/m | n/m | — | n/m | n/m | — | n/m | n/m | |||||||||||||
Others |
| 425 | (8) | (8) | 9 | (52) | 280 | (6) | (4) | 19 | (17) | (19) | 117 | (6) | (7) | |||||||||||||
Total Oncology |
| 23,698 | 17 | 16 | 11,187 | 18 | 5,350 | 19 | 21 | 4,880 | 20 | 15 | 2,281 | 5 | 5 | |||||||||||||
BioPharmaceuticals: CVRM |
| |||||||||||||||||||||||||||
Farxiga | 8,400 | 10 | 9 | 1,730 | (1) | 3,324 | 17 | 18 | 2,941 | 12 | 8 | 405 | (3) | (3) | ||||||||||||||
Crestor |
| 1,216 | 5 | 6 | 45 | (3) | 1,041 | 11 | 12 | 1 | (97) | (97) | 129 | (5) | (5) | |||||||||||||
Brilinta | 823 | (38) | (38) | 393 | (48) | 273 | (7) | (7) | 147 | (45) | (46) | 10 | (51) | (48) | ||||||||||||||
Lokelma |
| 698 | 29 | 28 | 301 | 18 | 129 | 50 | 52 | 129 | 39 | 34 | 139 | 29 | 28 | |||||||||||||
Seloken |
| 607 | — | 2 | — | — | 586 | (1) | 1 | 18 | 43 | 43 | 3 | 1 | 14 | |||||||||||||
Roxadustat |
| 274 | (17) | (17) | — | — | 274 | (17) | (17) | — | — | — | — | — | — | |||||||||||||
Wainua |
| 212 | n/m | n/m | 204 | n/m | 4 | n/m | n/m | 4 | n/m | n/m | — | — | — | |||||||||||||
Others |
| 534 | (28) | (28) | 49 | (74) | 262 | 4 | 5 | 158 | (30) | (32) | 65 | (17) | (17) | |||||||||||||
Total CVRM |
| 12,764 | 3 | 2 | 2,722 | (11) | 5,893 | 10 | 12 | 3,398 | 4 | — | 751 | (2) | (2) | |||||||||||||
BioPharmaceuticals: Respiratory & Immunology |
| |||||||||||||||||||||||||||
Symbicort |
| 2,885 | — | — | 1,193 | 1 | 801 | (1) | 1 | 560 | — | (3) | 331 | 1 | 3 | |||||||||||||
Fasenra |
| 1,981 | 17 | 16 | 1,195 | 14 | 117 | 27 | 29 | 482 | 19 | 15 | 187 | 29 | 30 | |||||||||||||
Breztri |
| 1,199 | 23 | 22 | 614 | 19 | 298 | 22 | 22 | 191 | 33 | 29 | 96 | 30 | 30 | |||||||||||||
Tezspire | 458 | 85 | 80 | — | — | 40 | n/m | n/m | 297 | 90 | 83 | 121 | 51 | 51 | ||||||||||||||
Saphnelo |
| 686 | 45 | 44 | 596 | 40 | 16 | n/m | n/m | 49 | 89 | 81 | 25 | 52 | 52 | |||||||||||||
Pulmicort |
| 518 | (24) | (24) | 5 | (21) | 414 | (27) | (27) | 63 | (12) | (15) | 36 | (1) | 1 | |||||||||||||
Airsupra |
| 166 | n/m | n/m | 162 | n/m | 4 | n/m | n/m | — | — | — | — | — | — | |||||||||||||
Others | 274 | (31) | (32) | 75 | (55) | 133 | (21) | (21) | 59 | 2 | — | 7 | (5) | (2) | ||||||||||||||
Total Respiratory & Immunology |
| 8,167 | 10 | 10 | 3,840 | 12 | 1,823 | (4) | (3) | 1,701 | 20 | 16 | 803 | 17 | 18 | |||||||||||||
BioPharmaceuticals: Vaccines & Immune Therapies |
| |||||||||||||||||||||||||||
Beyfortus |
| 281 | (12) | (12) | 184 | (21) | — | — | — | 94 | 12 | 12 | 3 | 58 | 53 | |||||||||||||
Synagis |
| 292 | (35) | (34) | (3) | (57) | 214 | 2 | 4 | 50 | (56) | (57) | 31 | (76) | (76) | |||||||||||||
FluMist |
| 272 | 6 | 3 | 28 | 1 | 5 | n/m | n/m | 210 | 3 | (1) | 29 | 19 | 19 | |||||||||||||
Others |
| 1 | (96) | (96) | — | n/m | 1 | (45) | (48) | — | n/m | n/m | — | n/m | n/m | |||||||||||||
Total Vaccines & Immune Therapies |
| 846 | (20) | (20) | 209 | (26) | 220 | 3 | 5 | 354 | (13) | (15) | 63 | (60) | (60) | |||||||||||||
Rare Disease: |
| |||||||||||||||||||||||||||
Ultomiris | 4,718 | 20 | 19 | 2,667 | 18 | 261 | 84 | 90 | 1,053 | 19 | 15 | 737 | 16 | 15 | ||||||||||||||
Soliris |
| 1,837 | (29) | (28) | 1,092 | (28) | 405 | (9) | (1) | 200 | (52) | (53) | 140 | (32) | (31) | |||||||||||||
Strensiq | 1,678 | 19 | 18 | 1,332 | 14 | 104 | 94 | 84 | 123 | 25 | 21 | 119 | 23 | 23 | ||||||||||||||
Koselugo |
| 662 | 25 | 22 | 219 | 3 | 228 | 29 | 25 | 161 | 57 | 51 | 54 | 38 | 38 | |||||||||||||
Others |
| 231 | 11 | 10 | 113 | 14 | 40 | 16 | 18 | 67 | 1 | (2) | 11 | 23 | 23 | |||||||||||||
Total Rare Disease |
| 9,126 | 5 | 5 | 5,423 | 3 | 1,038 | 22 | 26 | 1,604 | 2 | (1) | 1,061 | 7 | 7 | |||||||||||||
Other medicines |
| |||||||||||||||||||||||||||
Nexium |
| 816 | (6) | (5) | 67 | (30) | 611 | 3 | 5 | 50 | (18) | (20) | 88 | (26) | (26) | |||||||||||||
Others |
| 156 | (24) | (24) | (4) | n/m | 121 | (16) | (15) | 34 | (21) | (21) | 5 | 18 | 17 | |||||||||||||
Total Other medicines |
| 972 | (9) | (8) | 63 | (43) | 732 | — | 1 | 84 | (19) | (20) | 93 | (25) | (24) | |||||||||||||
Total Product Sales | 55,573 | 9 | 9 | 23,444 | 8 | 15,056 | 11 | 13 | 12,021 | 11 | 7 | 5,052 | 3 | 3 | ||||||||||||||
22
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 | |||||
23
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) | |||||||||||||
Imfinzi1 |
| 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) | |||
Note
1 | Prior to 2024, Imjudo Product Sales were included in the Imfinzi Product Sales figure with the Geographical review and within the “Financial Statements—Notes to the Group Financial Statements—Note 2—Revenue” on pages 140 to 141 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026. |
24
All commentary in “—Geographical Review” relates to Product Sales.
2025 in brief
Product Sales increased by 9% (CER: 9%) in 2025 to $55,573 million (2024: $50,938 million; 2023: $43,789 million). In 2025 we saw strong commercial performance across all of our therapy areas.
Product Sales in the US increased by 8% to $23,444 million (2024: $21,655 million; 2023: $17,961 million) reflecting the continued growth of our Oncology medicines, Ultomiris and Saphnelo, partially offset by a decline in Brilinta.
In 2025, Product Sales in Emerging Markets increased by 11% (CER: 13%) to $15,056 million (2024: $13,535 million; 2023: $11,751 million) driven by Oncology and CVRM medicines. China sales, comprising 44% of Emerging Markets sales, increased by 3% (CER: 4%) to $6,624 million (2024: $6,402 million; 2023: $5,867 million). China sales contributed to 12% of Product Sales in 2025.
Ex-China Emerging Markets Product Sales increased by 18% (21% at CER) to $8,432 million (2024: $7,133 million; 2023: $5,884 million) driven by driven by Oncology medicines and Farxiga. Among Oncology medicines in Ex-China Emerging Markets, Product Sales of Tagrisso increased by 24% (CER: 27%), Imfinzi increased by 49% (CER: 55%), and Calquence increased by 54% (CER: 56%). Product Sales of Farxiga in Ex-China Emerging Markets increased by 25% (CER: 28%) to $1,925 million (2024: $1,537 million; 2023: $1,183 million) in the year.
Product Sales in Europe increased by 11% (CER: 7%) to $12,021 million (2024: $10,848 million; 2023: $9,029 million). Sales of Oncology medicines comprised 41% of Europe Product Sales, which increased in 2025 by 20% (CER: 15%) to $4,880 million (2024: $4,082 million; 2023: $3,332 million) driven by sales of Tagrisso, Imfinzi, Calquence and Lynparza.
Product Sales in the Established ROW region increased by 3% (CER: 3%) to $5,052 million (2024: $4,900 million; 2023: $5,048 million) largely driven by Oncology medicines. Japan, comprising 71% of total Established ROW Product Sales, increased by 3% (CER: 2%) to $3,602 million (2024: $3,489 million; 2023: $3,654 million), largely driven by increased sales of Rare Disease medicine Ultomiris. Product Sales in Canada, which contributed 19% of total Established ROW Product Sales, increased by 2% (CER: 5%) to $954 million (2024: $937 million; 2023: $967 million).
2024 in brief
Product Sales increased by 16% (CER: 19%) in 2024 to $50,938 million (2023: $43,789 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) reflecting the continued growth of our Oncology medicines, Ultomiris and Symbicort.
In 2024, Product Sales in Emerging Markets increased by 15% (CER: 23%) to $13,535 million (2023: $11,751 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). 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) driven by Oncology medicines and Farxiga from CVRM. Among Oncology medicines in Ex-China Emerging Markets, Product Sales of Tagrisso increased by 14% (CER: 30%), Imfinzi increased by 44% (CER: 78%), and Lynparza increased by 23% (CER: 37%). Product Sales of Farxiga in Ex-China Emerging Markets increased by 30% (CER: 40%) to $1,537 million (2023: $1,183 million) in the year.
Product Sales in Europe increased by 20% (CER: 19%) to $10,848 million (2023: $9,029 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) driven by sales of Tagrisso, Imfinzi and Lynparza.
Product Sales in the Established ROW region decreased by 3% (CER: increased by 3%) to $4,900 million (2023: $5,048 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), due to a decline in sales of Oncology medicine Imfinzi and Vaccines & Immune Therapies medicine Synagis. Product Sales in Canada, which contributed 19% of total Established ROW Product Sales, decreased by 3% (CER: 2%) to $937 million (2023: $967 million).
25
2023 in brief
Product Sales increased by 2% (CER: 4%) in 2023 to $43,789 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%) and contributing 18% of AstraZeneca’s Total Product Sales.
Product Sales in the US increased by 4% to $17,961 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, representing 61% of total Rare Disease sales. This is largely driven by Product Sales of Ultomiris.
In 2023, Product Sales in Emerging Markets increased by 1% (CER: 8%) to $11,751 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. 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). 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 and Farxiga from CVRM. Product Sales of Vaxzevria in Ex-China Emerging Markets decreased by 99% (CER: 99%) to $10 million in the year. Product Sales of COVID-19 mAbs in Ex-China Emerging Markets decreased by 99% (CER: 99%) to $6 million in the year.
Product Sales in Europe increased by 9% (CER: 7%) to $9,029 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 and represented 37% of Europe sales, primarily driven by sales of Tagrisso, Lynparza and Imfinzi. 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 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, due to the decline in sales of COVID-19 medicines, Soliris and Nexium. Product Sales in Canada, which contributed 19% of total Established ROW Product Sales, decreased by 17% (CER: 14%) to $967 million.
Sales by Region in 2025
US
Product Sales in the US increased by 8% to $23,444 million (2024: $21,655 million; 2023: $17,961 million).
Oncology
Oncology sales in the US increased by 18% to $11,187 million (2024: $9,510 million; 2023: $7,719 million).
Tagrisso sales in the US increased by 11% to $3,064 million (2024: $2,763 million; 2023: $2,276 million), where the underlying demand growth more than offset Medicare Part D redesign.
Imfinzi sales in the US increased by 35% to $3,509 million (2024: $2,603 million; 2023: $2,317 million), as a result of demand growth across all indications, particularly new launches.
Calquence sales in the US increased by 7% to $2,339 million (2024: $2,190 million; 2023: $1,815 million), as a result of growth in new patient starts in CLL, 1L MCL (ECHO) launch and improved affordability offsetting Medicare Part D redesign and also discounts to secure preferential formulary placement.
Lynparza sales in the US increased by 8% to $1,434 million (2024: $1,332 million; 2023: $1,254 million) as a result of share gains across ovarian, breast and prostate indications.
Truqap sales in the US increased by 44% to $586 million (2024: $408 million; 2023: $6 million), as a result of a rapidly reached peak share in second-line biomarker-altered metastatic breast cancer, with the fourth quarter benefitting from year-end ordering dynamics.
Imjudo sales in the US increased by 26% to $227 million (2024: $180 million; 2023: $146 million), reflecting continued growth driven by lung (POSEIDON) and HCC (HIMALAYA).
26
CVRM
CVRM sales in the US decreased by 11% to $2,722 million (2024: $3,075 million; 2023: $2,752 million).
Farxiga sales in the US decreased by 1% to $1,730 million (2024: $1,750 million; 2023: $1,451 million), as the prior year benefitted from the launch of an authorised generic.
Crestor sales in the US decreased by 3% to $45 million (2024: $46 million; 2023: $55 million).
Brilinta sales in the US decreased by 48% to $393 million (2024: $751 million; 2023: $744 million), driven by generic entry in 2025.
Lokelma sales in the US increased by 18% to $301 million (2024: $256 million; 2023: $214 million).
Wainua sales in the US increased by 139% to $204 million (2024: $85 million; 2023: $nil).
Respiratory & Immunology
Respiratory & Immunology sales in the US increased by 12% to $3,840 million (2024: $3,416 million; 2023: $2,547 million).
Symbicort sales in the US increased by 1% to $1,193 million (2024: $1,187 million; 2023: $726 million) due to demand for an authorised generic partially offsetting brand price pressures.
Fasenra sales in the US increased by 14% to $1,195 million (2024: $1,049 million; 2023: $992 million) due to sustained double-digit volume growth with expanded class leadership, offset by an unfavourable gross-to-net adjustment in the fourth quarter.
Breztri sales in the US increased by 19% to $614 million (2024: $516 million; 2023: $383 million) as a result of consistent share growth within expanding FDC triple class; offset by an unfavourable gross-to-net adjustment in the fourth quarter.
Saphnelo sales in the US increased by 40% to $596 million (2024: $425 million; 2023: $260 million) as a result of strong demand growth.
Airsupra sales in the US increased by 145% to $162 million (2024: $66 million; 2023: $nil), reflecting strong launch momentum and volume uptake.
Vaccines & Immune Therapies
Vaccines & Immune Therapies in the US decreased by 26% to $209 million (2024: $280 million; 2023: $109 million).
Beyfortus sales in the US decreased by 21% to $184 million (2024: $232 million; 2023: $87 million), comprised of sales to Sanofi.
Rare Disease
Rare Disease sales in the US increased by 3% to $5,423 million (2024: $5,263 million; 2023: $4,701 million).
Ultomiris sales in the US increased by 18% to $2,667 million (2024: $2,261 million; 2023: $1,750 million), as a result of demand growth across indications, including within the competitive gMG and PNH landscapes.
Soliris sales in the US decreased by 28% to $1,092 million (2024: $1,523 million; 2023: $1,734 million), driven by conversion to Ultomiris, competition in gMG and PNH, and biosimilar pressure in gMG, PNH and aHUS.
Strensiq sales in the US increased by 14% to $1,332 million (2024: $1,167 million; 2023: $937 million) resulting from demand growth, offset by Medicare Part D redesign.
Koselugo sales in the US increased by 3% to $219 million (2024: $212 million; 2023: $195 million) driven by continued patient demand.
27
Other
Other medicines sales in the US decreased by 43% to $63 million (2024: $111 million; 2023: $133 million).
Nexium sales in the US decreased by 30% to $67 million (2024: $96 million; 2023: $115 million) due to generic erosion.
Emerging Markets
Product Sales in Emerging Markets increased by 11% (CER: 13%) to $15,056 million (2024: $13,535 million; 2023: $11,751 million).
Oncology
Oncology sales in Emerging Markets increased by 19% (CER: 21%) to $5,350 million (2024: $4,502 million; 2023: $3,828 million).
Tagrisso sales in Emerging Markets increased by 12% (CER: 14%) to $1,971 million (2024: $1,755 million; 2023: $1,621 million) due to continued demand growth, with quarterly revenue profile reflecting usual seasonal ordering dynamics in China.
Imfinzi sales in Emerging Markets increased by 34% (CER: 38%) to $640 million (2024: $479 million; 2023: $360 million) due to demand growth in GI (HIMALAYA, TOPAZ-1) and launches in lung cancer and bladder.
Calquence sales in Emerging Markets increased by 52% (CER: 54%) to $233 million (2024: $153 million; 2023: $98 million) due to 1L and r/r CLL growth.
Lynparza sales in Emerging Markets increased by 2% (CER: 1%) to $669 million (2024: $655 million; 2023: $542 million), affected by generic competition in China and stock compensation in the fourth quarter ahead of anticipated VBP implementation in the first quarter of 2026.
Enhertu sales in Emerging Markets increased by 91% (CER: 95%) to $668 million (2024: $350 million; 2023: $169 million) as a result of rapid adoption post-NRDL enlistment of HER2-positive and HER2-low breast cancer from 1 January 2025.
Zoladex sales in Emerging Markets increased by 6% (CER: 8%) to $842 million (2024: $795 million; 2023: $687 million).
Truqap sales in the Emerging Markets increased to $23 million (2024: $2 million; 2023: $nil).
Imjudo sales in the Emerging Markets increased by 40% (CER: 43%) to $22 million (2024: $16 million; 2023: $5 million).
CVRM
CVRM sales in Emerging Markets increased by 10% (CER: 12%) to $5,893 million (2024: $5,339 million; 2023: $4,586 million).
Forxiga sales in Emerging Markets increased by 17% (CER: 18%) to $3,324 million (2024: $2,853 million; 2023: $2,211 million) demonstrating continued strong growth despite generic competition in some markets as well as stock compensation in the fourth quarter ahead of anticipated VBP implementation in the first quarter of 2026.
Crestor sales in Emerging Markets increased by 11% (CER: 12%) to $1,041 million (2024: $934 million; 2023: $862 million).
Brilinta sales in Emerging Markets decreased by 7% (CER: 7%) to $273 million (2024: $294 million; 2023: $285 million).
Lokelma sales in Emerging Markets increased by 50% (CER: 52%) to $129 million (2024: $86 million; 2023: $50 million), demonstrating strong growth with launches in new markets.
Seloken sales in Emerging Markets decreased by 1% (CER: increased by 1%) to $586 million (2024: $589 million; 2023: $621 million).
28
Sales of roxadustat in Emerging Markets decreased by 17% (CER: 17%) to $274 million (2024: $331 million; 2023: $271 million), driven by generic competition and China VBP stock compensation in the fourth quarter.
Respiratory & Immunology
Respiratory & Immunology sales in Emerging Markets decreased by 4% (CER: 3%) to $1,823 million (2024: $1,897 million; 2023: $1,771 million).
Symbicort sales in Emerging Markets decreased by 1% (CER: increased by 1%) to $801 million (2024: $805 million; 2023: $753 million) as a result of China being affected by ICS/LABA class erosion in COPD in favour of FDC triple therapy.
Fasenra sales in Emerging Markets increased by 27% (CER: 29%) to $117 million (2024: $92 million; 2023: $64 million) due to asthma launch momentum across key markets.
Breztri sales in Emerging Markets increased by 22% (CER: 22%) to $298 million (2024: $245 million; 2023: $161 million) as a result of market share leadership in China with strong FDC triple class penetration.
Tezspire sales in Emerging Markets increased to $40 million (2024: $11 million; 2023: $1 million) as a result of strong continued launch uptake.
Pulmicort sales in Emerging Markets decreased by 27% (CER: 27%) to $414 million (2024: $568 million; 2023: $575 million) due to generic competition.
Vaccines & Immune Therapies
Vaccines & Immune Therapies in Emerging Markets increased by 3% (CER: 5%) to $220 million (2024: $213 million; 2023: $212 million).
Synagis sales in Emerging Markets increased by 2% (CER: 4%) to $214 million (2024: $210 million; 2023: $195 million).
Rare Disease
Rare Disease sales in Emerging Markets increased by 22% (CER: 26%) to $1,038 million (2024: $849 million; 2023: $623 million).
Ultomiris sales in Emerging Markets increased by 84% (CER: 90%) to $261 million (2024: $141 million; 2023: $71 million) as a result of expansion into new markets and growth in patient demand.
Soliris sales in Emerging Markets decreased by 9% (CER: 1%) to $405 million (2024: $443 million; 2023: $424 million).
Strensiq sales in Emerging Markets increased by 94% (CER: 84%) to $104 million (2024: $54 million; 2023: $40 million) due to the fourth quarter benefitting from the favourable timing of tender orders.
Koselugo sales in Emerging Markets increased by 29% (CER: 25%) to $228 million (2024: $177 million; 2023: $59 million) driven by growth in continued patient demand and geographic expansion.
Other
Other medicines sales in Emerging Markets were stable (CER: increased by 1%) at $732 million (2024: $735 million; 2023: $731 million).
Nexium sales in Emerging Markets increased by 3% (CER: 5%) to $611 million (2024: $591 million; 2023: $578 million).
Europe
Product Sales in Europe increased by 11% (CER: 7%) to $12,021 million (2024: $10,848 million; 2023: $9,029 million).
29
Oncology
Oncology sales in Europe increased by 20% (CER: 15%) to $4,880 million (2024: $4,082 million; 2023: $3,332 million).
Tagrisso sales in Europe increased by 9% (CER: 6%) to $1,423 million (2024: $1,301 million; 2023: $1,120 million), driven by demand growth partially offset by pricing pressure in certain major markets.
Imfinzi sales in Europe increased by 31% (CER: 26%) to $1,239 million (2024: $948 million; 2023: $758 million), due to growth from bladder and GI indications and momentum from lung cancer launches.
Calquence sales in Europe increased by 20% (CER: 15%) to $784 million (2024: $656 million; 2023: $493 million) as a result of early launch momentum in fixed duration 1L CLL (AMPLIFY).
Lynparza sales in Europe increased by 10% (CER: 6%) to $914 million (2024: $832 million; 2023: $734 million) driven by launches in breast and prostate cancers (OlympiA and PROpel).
Enhertu sales in Europe increased by 64% (CER: 58%) to $207 million (2024: $126 million; 2023: $60 million) as a result of demand growth in chemotherapy naïve HER2-low breast cancer and a favourable gross-to-net adjustment in the fourth quarter.
Zoladex sales in Europe increased by 6% (CER: 3%) to $157 million (2024: $148 million; 2023: $133 million).
Truqap sales in Europe increased to $85 million (2024: $12 million; 2023: $nil).
Imjudo sales in Europe increased by 43% (CER: 38%) to $52 million (2024: $36 million; 2023: $16 million).
CVRM
CVRM sales in Europe increased by 4% (stable at CER) to $3,398 million (2024: $3,270 million; 2023: $2,503 million).
Forxiga sales in Europe increased by 12% (CER: 8%) to $2,941 million (2024: $2,634 million; 2023: $1,881 million) due to demand growth offset by generic entry in the UK in the third quarter.
Brilique sales in Europe decreased by 45% (CER: 46%) to $147 million (2024: $268 million; 2023: $271 million) due to generic entry in the second quarter.
Lokelma sales in Europe increased by 39% (CER: 34%) to $129 million (2024: $92 million; 2023: $58 million).
Seloken sales in Europe increased by 43% (CER: 43%) to $18 million (2024: $13 million; 2023: $11 million).
Respiratory & Immunology
Respiratory & Immunology sales in Europe increased by 20% (CER: 16%) to $1,701 million (2024: $1,416 million; 2023: $1,164 million).
Symbicort sales in Europe were stable (CER: decreased by 3%) to $560 million (2024: $559 million; 2023: $549 million), impacted by continued generic erosion.
Fasenra sales in Europe increased by 19% (CER: 15%) to $482 million (2024: $404 million; 2023: $355 million), as a result of sustained leadership in severe eosinophilic asthma.
Trixeo sales in Europe increased by 33% (CER: 29%) to $191 million (2024: $143 million; 2023: $81 million), as a result of sustained growth from market share gain and new launches.
Tezspire sales in Europe increased by 90% (CER: 83%) to $297 million (2024: $156 million; 2023: $48 million) as a result of maintained new-to-brand leadership across multiple markets and new launches.
Saphnelo sales in Europe increased by 89% (CER: 81%) to $49 million (2024: $26 million; 2023: $8 million) due to ongoing launches.
Pulmicort sales in Europe decreased by 12% (CER: 15%) to $63 million (2024: $71 million; 2023: $68 million).
30
Vaccines & Immune Therapies
Vaccines & Immune Therapies sales in Europe decreased by 13% (CER: 15%) to $354 million (2024: $409 million; 2023: $396 million).
Beyfortus sales in Europe increased by 12% (CER: 12%) to $94 million (2024: $84 million; 2023: $19 million).
Synagis sales in Europe decreased by 56% (CER: 57%) to $50 million (2024: $116 million; 2023: $175 million), due to competition from Beyfortus.
FluMist sales in Europe increased by 3% (CER: decreased by 1%) to $210 million (2024: $204 million; 2023: $188 million).
Rare Disease
Rare Disease sales in Europe increased by 2% (CER: decreased by 1%) to $1,604 million (2024: $1,568 million; 2023: $1,529 million).
Ultomiris sales in Europe increased by 19% (CER: 15%) to $1,053 million (2024: $884 million; 2023: $668 million), as result of strong demand growth following recent launches, offset by competition in gMG and PNH.
Soliris sales in Europe decreased by 52% (CER: 53%) to $200 million (2024: $416 million; 2023: $670 million) due to conversion to Ultomiris, competition in gMG and PNH, and biosimilar pressure in PNH and aHUS.
Strensiq sales in Europe increased by 25% (CER: 21%) to $123 million (2024: $99 million; 2023: $89 million).
Koselugo sales in Europe increased by 57% (CER: 51%) to $161 million (2024: $103 million; 2023: $53 million) driven by growth in continued patient demand and geographic expansion.
Other
Other medicines sales in Europe decreased by 19% (CER: 20%) to $84 million (2024: $103 million; 2023: $105 million).
Nexium sales in Europe decreased by 18% (CER: 20%) to $50 million (2024: $60 million; 2023: $53 million) due to generic erosion.
Established ROW
Product Sales in the Established ROW region increased by 3% (CER: 3%) to $5,052 million (2024: $4,900 million; 2023: $5,048 million).
Oncology
Oncology sales in the Established ROW region increased by 5% (CER: 5%) to $2,281 million (2024: $2,181 million; 2023: $2,266 million). Oncology sales in Japan increased by 2% (CER: 1%) to $1,677 million (2024: $1,641 million; 2023: $1,804 million).
Tagrisso sales in the Established ROW region increased by 5% (CER: 5%) to $796 million (2024: $761 million; 2023: $782 million). Sales in Japan increased by 5% (CER: 4%) to $637 million in the year (2024: $609 million; 2023: $639 million).
Imfinzi sales in the Established ROW region decreased by 2% (CER: 2%) to $675 million (2024: $687 million; 2023: $802 million). Sales in Japan decreased by 4% (CER: 5%) to $570 million (2024: $591 million; 2023: $714 million) due to mandatory price reductions in February 2024 (25%), and August 2024 (11%) and increased competition in BTC (TOPAZ-1).
Calquence sales in the Established ROW region increased by 25% (CER: 27%) to $162 million (2024: $130 million; 2023: $108 million). Sales in Japan increased by 42% (CER: 41%) to $44 million (2024: $31 million; 2023: $20 million).
Lynparza sales in the Established ROW region increased by 3% (CER: 4%) to $262 million (2024: $253 million; 2023: $281 million) reflecting gains in 1L ovarian cancer, increasing share of pMMR endometrial cancer (DUO-E). Sales in Japan increased by 2% (CER: 1%) to $180 million (2024: $176 million; 2023: $210 million).
31
Enhertu sales in the Established ROW region increased by 47% (CER: 51%) to $102 million (2024: $69 million; 2023: $32 million).
Zoladex sales in the Established ROW region decreased by 11% (CER: 10%) to $88 million (2024: $99 million; 2023: $118 million). Sales in Japan decreased by 16% (CER: 16%) to $52 million (2024: $62 million; 2023: $83 million).
Truqap sales in the Established ROW region increased to $34 million (2024: $8 million; 2023: $nil). Sales in Japan increased to $27 million (2024: $7 million; 2023: $nil).
Imjudo sales in the Established ROW region decreased by 9% (CER: 9%) to $45 million (2024: $49 million; 2023: $52 million). Sales in Japan decreased by 9% (CER: 10%) to $40 million (2024: $44 million; 2023: $52 million).
CVRM
CVRM sales in the Established ROW region decreased by 2% (CER: 2%) to $751 million (2024: $764 million; 2023: $744 million). CVRM sales in Japan were stable (CER: decreased by 1%) to $624 million (2024: $624 million; 2023: $544 million).
Forxiga sales in the Established ROW region decreased by 3% (CER: 3%) to $405 million (2024: $419 million; 2023: $420 million). Japan sales decreased by 5% (CER: 6%) to $325 million (2024: $343 million; 2023: $298 million) as a result of generic T2D entry in the fourth quarter.
Crestor sales in the Established ROW region decreased by 5% (CER: 5%) to $129 million (2024: $136 million; 2023: $138 million). Sales in Japan decreased by 1% (CER: 1%) to $106 million (2024: $107 million; 2023: $105 million).
Lokelma sales in the Established ROW region increased by 29% (CER: 28%) to $139 million (2024: $108 million; 2023: $90 million) driven by launches in new markets. Sales in Japan increased by 29% (CER: 28%) to $136 million in the year (2024: $106 million; 2023: $88 million).
Respiratory & Immunology
Respiratory & Immunology sales in the Established ROW region increased by 17% (CER: 18%) to $803 million (2024: $687 million; 2023: $625 million). Respiratory & Immunology sales in Japan increased by 30% (CER: 29%) to $340 million (2024: $261 million; 2023: $241 million) in the year.
Symbicort sales in the Established ROW region increased by 1% (CER: 3%) to $331 million (2024: $328 million; 2023: $334 million). Sales in Japan increased by 19% (CER: 17%) to $56 million (2024: $47 million; 2023: $65 million).
Fasenra sales in the Established ROW region increased by 29% (CER: 30%) to $187 million (2024: $144 million; 2023: $142 million). Sales in Japan increased by 43% (CER: 41%) to $112 million (2024: $78 million; 2023: $82 million) driven by EGPA launch.
Breztri sales in the Established ROW region increased by 30% (CER: 30%) to $96 million (2024: $74 million; 2023: $52 million). Sales in Japan increased by 20% (CER: 19%) to $54 million (2024: $45 million; 2023: $37 million) due to increasing market share.
Tezspire sales in the Established ROW region increased by 51% (CER: 51%) to $121 million (2024: $81 million; 2023: $37 million) driven by growth in Japan. Sales in Japan increased by 39% (CER: 38%) to $87 million (2024: $63 million; 2023: $30 million).
Vaccines & Immune Therapies
Vaccines & Immune Therapies sales in the Established ROW region decreased by 60% (CER: 60%) to $63 million (2024: $156 million; 2023: $295 million). Vaccines & Immune Therapies sales in Japan decreased by 61% (CER: 61%) to $54 million (2024: $138 million; 2023: $234 million) in the year.
Synagis sales in the Established ROW region decreased by 76% (CER: 76%) to $31 million (2024: $129 million; 2023: $177 million) due to competition from Beyfortus. Sales in Japan decreased by 77% (CER: 77%) to $27 million (2024: $116 million; 2023: $150 million).
32
Rare Disease
Rare Disease sales in the Established ROW region increased by 7% (CER: 7%) to $1,061 million (2024: $988 million; 2023: $911 million). Rare Disease sales in Japan increased by 14% (CER: 13%) to $845 million (2024: $744 million; 2023: $675 million).
Ultomiris sales in the Established ROW region increased by 16% (CER: 15%) to $737 million (2024: $638 million; 2023: $476 million) driven by continued conversion and strong demand following new launches. Sales in Japan increased by 16% (CER: 15%) to $633 million (2024: $548 million; 2023: $441 million).
Soliris sales in the Established ROW region decreased by 32% (CER: 31%) to $140 million (2024: $206 million; 2023: $317 million) due to conversion to Ultomiris. Sales in Japan decreased by 25% (CER: 26%) to $56 million (2024: $75 million; 2023: $133 million).
Strensiq sales in the Established ROW region increased by 23% (CER: 23%) to $119 million (2024: $96 million; 2023: $86 million). Sales in Japan increased by 24% (CER: 23%) to $103 million (2024: $82 million; 2023: $74 million).
Koselugo sales in the Established ROW region increased by 38% (CER: 38%) to $54 million (2024: $39 million; 2023: $24 million) driven by growth in continued patient demand and geographic expansion. Sales in Japan increased by 29% (CER: 28%) to $45 million (2024: $35 million; 2023: $23 million).
Other
Other medicines sales in the Established ROW region decreased by 25% (CER: 24%) to $93 million (2024: $124 million; 2023: $207 million). Sales in Japan decreased by 25% (CER: 25%) to $61 million (2024: $82 million; 2023: $156 million).
Nexium sales in the Established ROW region decreased by 26% (CER: 26%) to $88 million (2024: $120 million; 2023: $199 million) due to generic erosion. Sales in Japan decreased by 28% (CER: 28%) to $56 million (2024: $78 million; 2023: $150 million).
Revenue recognition in the US
Product Sales are recorded at the invoiced amount (excluding inter-company sales and value-added taxes), less movements in estimated accruals for rebates and chargebacks given to managed care and other customers, which are a particular feature in the US and are considered to be key estimates. It is the Group’s policy to offer a credit note for all returns and to destroy all returned stock in all markets. Cash discounts for prompt payments are also discounted from sales. Sales are recognised when the control of the goods has been transferred to a third party, which is usually when title passes to the customer, either on shipment or on the receipt of goods by the customer, depending on local trading terms.
Rebates, chargebacks and returns in the US
When invoicing Product Sales in the US, we estimate the rebates and chargebacks that we expect to pay, which are considered to be estimates. These rebates typically arise from sales contracts with third-party managed care organisations, hospitals, long-term care facilities, group purchasing organisations and various federal or state programmes (Medicaid contracts, supplemental rebates, etc.). They can be classified as follows:
| ● | Chargebacks, where we enter into arrangements under which certain parties, typically hospitals, long-term care facilities, group purchasing organisations, the Department of Veterans Affairs, Public Health Service Covered Entities, and the Department of Defense, are able to buy products from wholesalers at the lower prices we have contracted with them. The chargeback is the difference between the price we invoice to the wholesaler and the contracted price charged by the wholesaler to the other party. Chargebacks are credited directly to the wholesalers. |
| ● | Regulatory rebates, including Medicaid and other federal and state programmes, where we pay rebates based on the specific terms of agreements with the US Department of Health and Human Services and with individual states, which include product usage and information on best prices and average market price benchmarks. |
| ● | Contractual rebates, under which entities such as third-party managed care organisations are entitled to rebates depending on specified performance provisions, which vary from contract to contract. |
The effects of these deductions on our US pharmaceuticals revenue and the movements on US pharmaceuticals revenue provisions are set out in the tables below.
33
Accrual assumptions are built up on a product-by-product and customer-by customer basis, taking into account specific contract provisions coupled with expected performance, and are then aggregated into a weighted average rebate accrual rate for each of our products. Accrual rates are reviewed and adjusted on an as-needed basis. There may be further adjustments when actual rebates are invoiced based on utilisation information submitted to us (in the case of contractual rebates) and claims/invoices are received (in the case of regulatory rebates and chargebacks). We believe that we have made reasonable estimates for future rebates using a similar methodology to that of previous years. Inevitably, however, these estimates involve assumptions in respect of aggregate future sales levels, segment mix and customers’ contractual performance.
Overall adjustments between gross and net US Product Sales amounted to $23,941 million in 2025 (2024: $18,986 million) with the increase driven predominantly by increased rebates from contractual arrangements and chargebacks.
Cash discounts are offered to customers to encourage prompt payment. Accruals are calculated based on historical experience and are adjusted to reflect actual experience. Our revenue recognition policy is described within Group Accounting Policies in “Financial Statements—Group Accounting Policies” on page 129 to 136 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026.
Industry practice in the US allows wholesalers and pharmacies to return unused stocks within a certain time frame based on shelf-life expiry. The customer is credited for the returned product by the issuance of a credit note. Returned products are not exchanged for products from inventory and once a return claim has been determined to be valid and a credit note has been issued to the customer, the returned products are destroyed. At the point of sale in the US, we estimate the quantity and value of products which may ultimately be returned. Our returns accruals in the US are based on actual experience. Our estimate is based on the historical sales and returns information for established products together with market-related information, such as estimated shelf life, product recall, and estimated stock levels at wholesalers, which we receive via third-party information services. For newly launched products, we use rates based on our experience with similar products or a pre-determined percentage.
Gross to Net Product Sales
US pharmaceuticals
| 2025 | | 2024 | | 2023 | |
($m) | ||||||
Gross Product Sales |
| 47,385 |
| 40,641 |
| 36,568 |
Chargebacks |
| (5,113) |
| (3,969) |
| (3,075) |
Regulatory – Medicaid and state programmes |
| (2,527) |
| (2,184) |
| (2,417) |
Contractual – Managed care and Medicare |
| (13,963) |
| (10,825) |
| (11,035) |
Cash and other discounts |
| (483) |
| (430) |
| (428) |
Customer returns |
| (149) |
| (111) |
| (222) |
US branded pharmaceutical fee |
| (99) |
| (114) |
| (124) |
Other |
| (1,607) |
| (1,353) |
| (1,306) |
Net Product Sales |
| 23,444 |
| 21,655 |
| 17,961 |
Movements in accruals
US pharmaceuticals
| Brought | | | Adjustment in | | | Carried | |||
forward at 1 | Provision for | respect of prior | Returns and | forward at 31 | ||||||
January 2025 | current year | years | payments | December 2025 | ||||||
($m) | ||||||||||
Chargebacks |
| 344 |
| 4,651 |
| 4 |
| (4,568) |
| 431 |
Regulatory – Medicaid and state programmes |
| 860 |
| 2,532 |
| (42) |
| (2,472) |
| 878 |
Contractual – Managed care and Medicare |
| 3,066 |
| 14,059 |
| (92) |
| (13,381) |
| 3,652 |
Cash and other discounts |
| 23 |
| 483 |
| — |
| (480) |
| 26 |
Customer returns |
| 280 |
| 133 |
| (2) |
| (135) |
| 276 |
US branded pharmaceutical fee |
| 177 |
| 155 |
| (43) |
| (124) |
| 165 |
Other |
| 228 |
| 1,604 |
| — |
| (1,319) |
| 513 |
Total |
| 4,978 |
| 23,617 |
| (175) |
| (22,479) |
| 5,941 |
34
| Brought | | | Adjustment in | | | Carried | |||
forward at 1 | Provision for | respect of prior | Returns and | forward at 31 | ||||||
January 2024 | current year | years | payments | December 2024 | ||||||
($m) | ||||||||||
Chargebacks |
| 245 |
| 3,530 |
| 46 |
| (3,477) |
| 344 |
Regulatory – Medicaid and state programmes |
| 986 |
| 2,185 |
| (18) |
| (2,293) |
| 860 |
Contractual – Managed care and Medicare |
| 3,127 |
| 10,962 |
| (122) |
| (10,901) |
| 3,066 |
Cash and other discounts |
| 31 |
| 430 |
| — |
| (438) |
| 23 |
Customer returns |
| 273 |
| 98 |
| — |
| (91) |
| 280 |
US branded pharmaceutical fee |
| 172 |
| 159 |
| (44) |
| (110) |
| 177 |
Other |
| 282 |
| 1,346 |
| — |
| (1,400) |
| 228 |
Total |
| 5,116 |
| 18,710 |
| (138) |
| (18,710) |
| 4,978 |
| Brought | | | Adjustment in | | | Carried | |||
forward at 1 | Provision for | respect of prior | Returns and | forward at 31 | ||||||
January 2023 | current year | years | payments | December 2023 | ||||||
($m) | ||||||||||
Chargebacks |
| 233 |
| 2,743 |
| (22) |
| (2,709) |
| 245 |
Regulatory – Medicaid and state programmes |
| 771 |
| 2,468 |
| (59) |
| (2,194) |
| 986 |
Contractual – Managed care and Medicare |
| 2,426 |
| 11,166 |
| (92) |
| (10,373) |
| 3,127 |
Cash and other discounts |
| 27 |
| 428 |
| — |
| (424) |
| 31 |
Customer returns |
| 205 |
| 204 |
| — |
| (136) |
| 273 |
US branded pharmaceutical fee |
| 137 |
| 133 |
| (5) |
| (93) |
| 172 |
Other |
| 162 |
| 1,303 |
| — |
| (1,183) |
| 282 |
Total |
| 3,961 |
| 18,445 |
| (178) |
| (17,112) |
| 5,116 |
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 2025, 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, 2025, the Company’s gross revenues and net profits attributable to the above-mentioned Iranian activities were $33 million and $19 million respectively. For the same period, AstraZeneca’s gross revenues and net profits were $58.7 billion and $10.2 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 0.19% 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.
35
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 224 and “Financial Statements—Group Subsidiaries and Holdings” on pages 192 to 196, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 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—2025 compared with 2024”. The information (including tabular data) set forth under the headings “Strategic Report—Business Review—Science and Innovation—Research & Development” on pages 28 to 29, “Strategic Report—Business Review—Growth and Therapy Area Leadership—Operations” on page 33, “Strategic Report—Business Review—Growth and Therapy Area Leadership—Digital technologies” on page 36, “Strategic Report—Business Review—Growth and Therapy Area Leadership—Cybersecurity and data privacy” on page 36, “Financial Statements—Notes to the Group Financial Statements—Note 8—Property, plant and equipment” on page 149, “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments, contingent liabilities and contingent assets—Environmental costs and liabilities” on pages 180 and 181, and “Financial Statements—Notes to the Group Financial Statements—Note 9—Leases” on page 150, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 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 8—Property, plant and equipment” on page 149 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026.
ITEM 4A. UNRESOLVED STAFF COMMENTS
Not applicable.
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS
The information (including graphs and tabular data) set forth under the headings “Strategic Report—Our Strategy and Key Performance Indicators” on pages 10 to 11, “Financial Statements— Notes to the Group Financial Statements—Note 2—Revenue” on pages 140 to 141, “Financial Statements—Notes to the Group Financial Statements—Note 28—Financial risk management objectives and policies” on pages 171 to 177, and “Additional Information—Important information for readers of this Annual Report” on page 228, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 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
2025 compared with 2024
The information set forth under the heading “Strategic Report—Financial Review” on pages 50 to 64 (excluding the information set forth under the subheadings “Full year 2026: additional commentary” and “Currency impact” on page 64) of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 is incorporated herein by reference.
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 the Form 20-F dated February 18, 2025 is incorporated herein by reference.
36
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 2025” and “—Summary cash flows” on page 60, “Strategic Report—Financial Review—Financial position - 31 December 2025” on pages 62 to 63, “Strategic Report—Financial Review—Capitalisation and shareholder return” on page 63, “Financial Statements—Notes to the Group Financial Statements—Note 19—Interest-bearing loans and borrowings” on pages 157 to 158, “Financial Statements—Notes to the Group Financial Statements—Note 14—Derivative financial instruments” on page 155, “Financial Statements—Notes to the Group Financial Statements—Note 23—Reserves” on pages 168 to 169, “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments, contingent liabilities and contingent assets” on pages 180 to 190, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 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 28 to 29, “Strategic Report—Business Review—Science and Innovation—Development pipeline overview” on page 30, and “Strategic Report—Business Review—Science and Innovation—Sustainable innovation—Intellectual property” on page 30, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 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 10, 2026” and “—Patent Expiries of Key Marketed Products as at February 10, 2026”.
D.Trend information
The information set forth in the introductory paragraph under the heading “Strategic Report—Financial Review” on page 50 and the information (including graphs and tabular data) set forth under the headings “Strategic Report—Our Strategy and Key Performance Indicators” on pages 10 to 11, “Strategic Report—Financial Review—Measuring performance” on page 52, “Financial Statements— Notes to the Group Financial Statements—Note 2—Revenue” on pages 140 to 141, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 is incorporated by reference.
E.Critical Accounting Estimates
The information set forth under the heading “Financial Statements—Group Accounting Policies” on pages 129 to 136 and “Financial Statements—Notes to the Group Financial Statements—Note 30—Commitments, contingent liabilities and contingent assets” on pages 180 to 190 in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 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 10 February 2026” on pages 68 to 69, and “Corporate Governance—Directors’ Remuneration Report—Annual Report on Remuneration—Governance—Directors’ service contracts and letters of appointment” on page 113, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 is incorporated by reference.
37
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 10 February 2026” on page 70 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 is incorporated by reference.
Senior Executive Team (SET) Biographies as at 10 February 2026
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.
38
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.
39
B.Compensation
The information (including graphs and tabular data) set forth under the headings “Corporate Governance—Directors’ Remuneration Report” on pages 90 to 93, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—5. Remuneration” on page 73, “Strategic Report—Our Strategy and Key Performance Indicators—Our Key Performance Indicators and remuneration” on page 10, “Financial Statements—Notes to the Group Financial Statements—Note 22—Post-retirement pension and other defined benefit schemes” on pages 161 to 168, “Financial Statements—Notes to the Group Financial Statements—Note 29—Employee costs and share plans for employees” on pages 178 to 180 and “Financial Statements—Notes to the Group Financial Statements—Note 31—Statutory and other information—Key management personnel compensation”, on page 191, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 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 67, “Corporate Governance—Board of Directors as at 10 February 2026” on pages 68 to 69, “Corporate Governance—Senior Executive Team (SET) as at 10 February 2026” on page 70, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—1. Board leadership and Company purpose” on page 71, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—2. Division of responsibilities” on pages 71 to 72, “Corporate Governance—Corporate Governance Report—Compliance with the UK Corporate Governance Code—5. Remuneration” on page 73, “Corporate Governance—Sustainability Committee Report” on page 82, “Corporate Governance—Compliance with the UK Corporate Governance Code—Further information on risk management and controls—Global Compliance and GIA” on page 73, “Corporate Governance—Nomination and Governance Committee Report” on pages 79 to 80, “Corporate Governance—Science Committee Report” on page 81, “Corporate Governance—Directors’ Remuneration Report—Annual Report on Remuneration—Governance—Directors’ service contracts and letters of appointment” on page 113, “Corporate Governance—Directors’ Remuneration Report—Remuneration at a glance—Looking ahead—Executive Directors’ remuneration for 2026” on page 94, “Corporate Governance—Directors’ Remuneration Report—Annual Report on Remuneration—Executive Directors’ remuneration” on pages 97 to 105, “Corporate Governance—Directors’ Remuneration Report—Annual Report on Remuneration—Non-Executive Directors’ remuneration” on page 106 and “Corporate Governance—Audit Committee Report” on pages 83 to 89, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 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 28 to 29, “Strategic Report—Business Review—Growth and Therapy Area Leadership—Summary and performance indicators” on page 32, “Strategic Report—Business Review—Growth and Therapy Area Leadership—Business conduct” on pages 34 to 35, “Strategic Report—Business Review—Growth and Therapy Area Leadership—Operations” on page 33, “Strategic Report—Business Review—Growth and Therapy Area Leadership—Business development” on page 37, “Strategic Report—Business Review—People and Sustainability—Summary and performance indicators” on page 38, and “Financial Statements—Notes to the Group Financial Statements—Note 29—Employee costs and share plans for employees” (including the tabular data) on pages 178 to 180, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 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 178 to 180, and “Corporate Governance—Directors’ Remuneration Report—Annual Report on Remuneration—Directors’ shareholdings” on pages 107 to 108, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 is incorporated by reference.
40
Directors’ and SET shareholdings
At January 31, 2026, 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 |
| 544,012 |
| 0.04 | % |
Options to purchase securities from registrant or subsidiaries
At January 31, 2026, options outstanding to subscribe for Ordinary Shares were:
Number of shares | | Subscription price (pence) | | Normal expiry date |
1,095,499 |
| 6839 - 10441 |
| 2025 - 2031 |
The weighted average subscription price of options outstanding at January 31, 2026 was 9156 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 2025, no options were held by Directors. During the period January 1, 2026 to January 31, 2026, no Director was granted or exercised any options.
F.Disclosure of a registrant’s action to recover erroneously awarded compensation
Not applicable.
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 225 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 is incorporated by reference.
Issued share capital, shareholdings and share prices
At 31 December 2025, the Company had 61,133 registered holders of 1,550,907,927 Ordinary Shares. There were 174,889 holders of Ordinary Shares held under the Euroclear Services Agreement, representing 9.9% of the issued share capital of the Company and 4,598 registered holders of ADSs, representing 18.3% of the issued share capital of the Company.
Ordinary Shares in issue
Ordinary Shares in issue - millions | | 2025 | | 2024 | | 2023 |
At year-end |
| 1,551 |
| 1,551 |
| 1,550 |
Weighted average for year |
| 1,550 |
| 1,550 |
| 1,549 |
Stock market closing price per Ordinary Share (London Stock Exchange) |
| |
| |
| |
Highest (pence) |
| 14,148 |
| 13,276 |
| 12,294 |
Lowest (pence) |
| 9,667 |
| 9,501 |
| 9,900 |
At year end (pence) |
| 13,790 |
| 10,468 |
| 10,600 |
Analysis of shareholdings as a percentage of issued share capital at 31 December
| 2025 | | 2024 | | 2023 | |
Number of Ordinary Shares(1) | % | % | % | |||
1-250 |
| 0.2 |
| 0.2 |
| 0.3 |
251-500 |
| 0.3 |
| 0.3 |
| 0.3 |
501-1,000 |
| 0.3 |
| 0.3 |
| 0.4 |
1,001-5,000 |
| 0.5 |
| 0.5 |
| 0.5 |
5,001-10,000 |
| 0.2 |
| 0.2 |
| 0.2 |
10,001-50,000 |
| 1.1 |
| 1.1 |
| 1.1 |
50,001-1,000,000 |
| 11.7 |
| 11.2 |
| 11.3 |
Over 1,000,000 |
| 85.7 |
| 86.2 |
| 85.9 |
Note
1Includes Euroclear and ADR holdings.
41
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 191, “Additional Information—Shareholder information—Related party transactions” on pages 223, and “Additional Information—Directors’ Report—Major shareholdings” on page 225, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 is incorporated by reference.
C.Interests of Experts and Counsel
Not applicable.
ITEM 8. FINANCIAL INFORMATION
A.Consolidated Statements and Other Financial Information
Please see the information below under the heading Item 18—“Financial Statements.” The information (including graphs and tabular data) set forth under the headings “Additional Information—Shareholder information” on page 223, “Strategic Report—Financial Review—Dividend and share repurchases” on page 63 and “Additional Information—Directors’ Report—Distributions to shareholders – dividends for 2025” on page 225, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 is incorporated by reference.
Summarized financial information for guarantee of securities of subsidiaries
AstraZeneca Finance LLC (“AstraZeneca Finance”) is the issuer of 1.2% Notes due 2026, 4.8% Notes due 2027, 4.875% Notes due 2028, 1.75% Notes due 2028, 4.85% Notes due 2029, 4.9% Notes due 2030, 4.9% Notes due 2031, 2.25% Notes due 2031, 4.875% Notes due 2033 and 5% Notes due 2034 (the “AstraZeneca Finance USD Notes”). Each series of AstraZeneca Finance USD Notes has been fully and unconditionally guaranteed by AstraZeneca PLC. AstraZeneca Finance is 100% owned by AstraZeneca PLC and each of the guarantees issued by AstraZeneca PLC is full and unconditional and joint and several.
The AstraZeneca Finance USD 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 USD 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 USD Notes are structurally subordinated to indebtedness and other liabilities of the subsidiaries of AstraZeneca PLC, none of which guarantee the AstraZeneca Finance USD 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 under 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 2025 | | FY 2024 | |
$m | $m | |||
Total Revenue |
| — |
| — |
Gross profit |
| — |
| — |
Operating loss |
| (27) |
| (34) |
Loss for the period |
| (1,756) |
| (1,182) |
Transactions with subsidiaries that are not issuers or guarantors |
| 7,588 |
| 1,661 |
42
Obligor group summarised Statement of Financial Position information
| At 31 Dec 2025 | | At 31 Dec 2024 | |
$m | $m | |||
Current assets |
| 34 |
| 54 |
Non-current assets |
| 124 |
| — |
Current liabilities |
| (2,975) |
| (2,347) |
Non-current liabilities |
| (24,687) |
| (26,603) |
Amounts due from subsidiaries that are not issuers or guarantors |
| 19,322 |
| 18,272 |
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 181 to 189 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 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 pages 32 to 33 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 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 191 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 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 page 223 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 is incorporated by reference. Please also see the information below under the heading Item 7.A—“Major Shareholders” for information on ordinary shares in issue.
The corresponding trading symbol is “AZN” in each of AstraZeneca’s principal markets for trading in AstraZeneca shares.
B. Plan of Distribution
Not applicable.
C.Markets
The information set forth in the introductory paragraph under the heading “Additional Information—Shareholder information” on page 223 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 is incorporated by reference.
D.Selling Shareholders
Not applicable.
E.Dilution
Not applicable.
43
F.Expenses of the Issue
Not applicable.
ITEM 10. ADDITIONAL INFORMATION
A.Share Capital
Not applicable.
B.Memorandum and Articles of Association
The information set forth under the heading “Additional Information—Directors’ Report—Articles of Association” on page 225 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 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
Not applicable.
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.
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 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 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 24, 2026, each of which may change, possibly with retroactive effect. This summary does not describe all of the US federal income 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, such as banks, dealers, traders who elect to mark to market, tax-exempt entities, insurance companies, US holders who hold Ordinary Shares as part of a hedge, straddle, conversion or integrated transaction or holders who have a “functional currency” other than the US dollar. In addition, the discussion does not address tax consequences to an entity treated as a partnership for US federal income tax purposes that holds the Ordinary Shares, or a partner in such partnership.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 in their particular circumstances.
Termination of the ADR programme
The termination of the ADR programme and listing of the Ordinary Shares generally should not be a taxable event for US holders. However, US holders should consult their tax advisors regarding the UK and US federal income tax consequences of their particular circumstances.
44
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 be the US dollar value of the foreign currency payment received determined at the spot rate of the relevant foreign currency on the date the dividend is received, 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. US holders 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 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, unless such Ordinary Shares 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 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. Non-corporate US holders (including individuals) who have held the Ordinary Shares for more than one year will be eligible for reduced rates. 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 2025. 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.
45
UK inheritance tax
Ordinary Shares 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, provided that any applicable US federal gift or estate tax liability is paid, except in certain cases where the Ordinary Shares: (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 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
Transfers of Ordinary Shares within the DTC clearance system will generally not be subject to UK stamp duty provided that no written instrument of transfer is used to effect the transfer (such an instrument of transfer should not be necessary in respect of Ordinary Shares held within the DTC clearance system).
While the Ordinary Shares held within the DTC clearance system, agreements to transfer such Ordinary Shares should not be subject to SDRT (provided DTC continues to satisfy various conditions specified in UK legislation).
Transfers of, or agreements to transfer, Ordinary Shares from the DTC clearance system into another clearance system (or into a depositary receipt system) should not be subject to UK stamp duty or SDRT, provided that the other clearance system or depositary receipt system satisfies various conditions specified in UK legislation.
Ordinary Shares which are held outside of the DTC clearing system and which are transferred into the DTC clearance system will generally be subject to UK stamp duty or SDRT at the rate of 1.5% of the amount of the consideration given or, if there is no consideration in money or money’s worth given, the market value of the Ordinary Shares. Any 1.5% charges arising in these circumstances will generally need to be paid by the transferor as a precondition to the transfer into the DTC clearance system.
A transfer of Ordinary Shares which are held outside the DTC clearance system and are transferred by way of written instrument will generally be subject to UK stamp duty at the rate of 0.5% (rounded up to the next multiple of £5) of the amount or value of the consideration given. Other than in the circumstances described above for Ordinary Shares held in or transferred to the DTC clearance system, a charge to SDRT will also arise on an unconditional agreement to transfer shares at the rate of 0.5% of the amount or value of the consideration payable. However, if within six years of the date of the agreement becoming unconditional an instrument of transfer is executed pursuant to that agreement, and stamp duty is paid on that instrument, any SDRT already paid will be refunded (generally, but not necessarily, with interest) provided that a claim for repayment is made, and any outstanding liability to SDRT will be cancelled.
F.Dividends and Paying Agents
Not applicable.
G. Statement by Experts
Not applicable.
H.Documents on Display
The Company’s Articles of Association and other documents concerning the Company which are referred to in this Form 20-F dated February 24, 2026, 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
Not applicable.
46
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 64 and “Financial Statements—Notes to the Group Financial Statements—Note 28—Financial risk management objectives and policies” on pages 171 to 177, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 is incorporated by reference.
ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
A.Debt Securities
Not applicable.
B.Warrants and Rights
Not applicable.
C. Other Securities
Not applicable.
D. American Depositary Shares
On January 30, 2026, the Company filed a Form 25 with respect to the delisting of its American Depositary Shares from Nasdaq. The delisting became effective on January 30, 2026, and the American Depositary Receipt (ADR) programme was terminated on February 2, 2026. The effective date of the direct listing of the Ordinary Shares on the New York Stock Exchange was February 2, 2026.
47
PART II
ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
Not applicable.
ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
Not applicable.
ITEM 15. CONTROLS AND PROCEDURES
A. 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 73, “Corporate Governance—Audit Committee Report—Internal controls” on page 86, and “Financial Statements—Directors’ Annual Report on Internal Controls over Financial Reporting” on page 115, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 is incorporated by reference.
US corporate governance requirements
The Company delisted its American Depositary Shares from Nasdaq effective January 30, 2026 and directly listed its Ordinary Shares on the New York Stock Exchange on February 2, 2026. As the Company’s Ordinary Shares are traded on the NYSE, 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 115 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026, 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, 2025, has been audited by PricewaterhouseCoopers LLP, independent registered public accounting firm, as stated in its report dated February 10, 2026, 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 2025—Board Committee membership and meeting attendance in 2025” on page 67 and “Corporate Governance—Audit Committee Report—Committee overview—Committee composition” on page 84, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 is incorporated by reference.
48
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 34 to 35, “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 73, “Strategic Report—Business Review—Science and Innovation—Sustainable innovation” on page 30, and “Corporate Governance—Audit Committee Report—Activities during the year—Legal and Compliance” on page 85, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 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
Year ended December 31, | ||||||
| 2025 | | 2024 | | 2023 | |
($ million) | ||||||
Audit fees |
| 32.5 | 29.4 | 29.1 | ||
Audit-related fees |
| 1.1 | 2.1 | 0.8 | ||
All other fees |
| 0.2 | 0.3 | 0.2 | ||
Total |
| 33.8 | 31.8 | 30.1 | ||
Audit fees included $15.8 million for the audit of subsidiaries pursuant to legislation (2024: $14.8 million), $12.5 million for the Group audit (2024: $10.6 million), $0.5 million for services in relation to the interim financial statements (2024: $0.5 million) and $3.7 million in respect of section 404 of the Sarbanes-Oxley Act (2024: $3.5 million). Fees payable in the year of $0.8 million (2024: $0.2 million) are in respect of the Group audit and audit of subsidiaries related to prior years.
Audit-related fees included $0.8 million of other audit-related services (2024: $1.7 million) and $0.3 million for the audit of subsidiaries’ pension schemes (2024: $0.4 million).
All other fees of $0.2 million related to other assurance services (2024: $0.3 million).
The information (including tabular data) set forth under the heading “Corporate Governance—Audit Committee Report” on pages 83 to 89 of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 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 2025 and 2024, 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
Not applicable.
ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS
Not applicable.
49
ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT
Following a rigorous process, the Company concluded an audit tender in 2024 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. PricewaterhouseCoopers LLP (“PwC”), who have been the Company’s independent auditor since the year ended December 31, 2017, did 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, 2025, 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, 2025, 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 15.4 to this Form 20-F dated February 24, 2026.
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, 2025. 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’s Ordinary Shares are listed on the New York Stock Exchange and, under the NYSE Corporate Governance Standards (the “NYSE Standards”) 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 NYSE Standards.
The Company is required to disclose any significant ways in which its corporate governance practices differ from those followed by US companies under the NYSE Standards. In addition, the Company must comply fully with the provisions of the NYSE Standards 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 NYSE Standards and its corporate governance practices are generally consistent with those standards.
50
A summary of the significant ways in which the Company’s corporate governance practices differ from those followed by US domestic companies under the NYSE Standards is set forth below.
NYSE Standards | | AstraZeneca Corporate Governance Practice |
1. Under the NYSE Standards, the audit committee is to be directly responsible for the appointment, compensation, retention and oversight of a listed company’s external auditor, unless there is a conflicting requirement under the home country laws of the company. |
| 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 NYSE Standards, the nominating/corporate governance committee and compensation committee are to be composed entirely 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. 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. |
3. Under the NYSE Standards, the compensation committee is to make recommendations to the listed company’s Board of Directors with respect to non-CEO executive officer compensation and certain other compensation plans which are subject to Board approval. |
| 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. |
4. Under the NYSE Standards, shareholders are entitled to vote on all equity compensation plans and material revisions thereto, with certain limited exemptions. |
| 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). |
5. Under the NYSE Standards, each listed company Chief Executive Officer must certify to the NYSE each year that he or she is not aware of any violation by the listed company of any NYSE corporate governance listing standards. |
| As the Company is a foreign private issuer, the Company’s Chief Executive Officer is not required to make this certification. He is, however, required to promptly notify the NYSE in writing after any executive officer of the Company becomes aware of any non- compliance with any NYSE corporate governance rules applicable to the Company. The FCA Rules require the Company to include a statement in its annual report and accounts as to whether it has complied throughout the applicable accounting period with all relevant provisions set out in the U.K. Code or, if it has not complied, set out those provisions it has not complied with and its reasons for non-compliance. |
51
ITEM 16H. MINE SAFETY DISCLOSURE
Not applicable.
ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
ITEM 16J. INSIDER TRADING POLICIES
As part of its Global Policy Framework, the Company has
ITEM 16K. CYBERSECURITY
Risk and Management Strategy
Governance
Cybersecurity remains a core AstraZeneca enterprise risk focus area.
52
The information set forth under the heading “Strategic Report—Business Review—Growth and Therapy Area Leadership—Cybersecurity and data privacy” on page 36, “Strategic Report—Risk Overview—Cybersecurity risk” on page 47, “Strategic Report—Risk Overview—Principal Risks—Supply chain and business execution risks—Failure in information technology or cybersecurity” on page 48, and “Corporate Governance—Audit Committee Report—Activities during the year—Cybersecurity risk, digital security and information governance” on page 84, in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 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.
53
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 114 to 191 (excluding the information set forth under the subheading “Independent Auditors’ Report to the Members of AstraZeneca PLC” on pages 116 to 124), in each case of AstraZeneca’s “Annual Report and Form 20-F Information 2025” included as exhibit 15.1 to this Form 20-F dated February 24, 2026 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 2025 and 2024, 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 2025, 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 2025, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Group as of 31 December 2025 and 2024, and the results of its operations and its cash flows for each of the three years in the period ended 31 December 2025 in conformity 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 2025, based on criteria established in Internal 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.
54
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 2 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 2025 amounted to $5,941 million (including $336 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.
55
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 judgement made by management when developing the estimate for 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 (ii) high degree of auditor judgement, subjectivity, and effort in performing procedures and evaluating management’s significant assumptions related to aggregate future sales levels, segment mix and customers’ contractual performance, the channel inventory levels, and lag time and (iii) the audit effort involved the use of professionals with specialised skill and knowledge.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to management’s recognition and measurement of the Managed Care, Medicaid, and Medicare Part D rebate accruals, including controls over the significant assumptions. These procedures also included, among others, (i) testing completeness and accuracy of data provided by management (ii) evaluating the reasonableness of management’s estimate by (a) developing an independent estimate of these accruals and (b) comparing the independent estimate to management‘s estimate (iii) evaluating 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 independently evaluating the terms of the specific rebate programmes and/or contracts with customers; historical revenue data; market demand and market conditions in the US; third party information on inventory held by direct and indirect customers; and the historical trend of actual rebate claims paid. Professionals with specialised skill and knowledge were used to assist in assessing the compliance of the Group’s Medicaid rebate policies against the regulatory requirements.
Impairment assessment of the product, marketing and distribution rights and other intangibles
As described in the Group Accounting Policies and Note 11 to the consolidated financial statements, the Group has product, marketing and distribution rights totalling $35,934 million and other intangibles totalling $818 million (hereafter the intangible assets) at 31 December 2025. For the year ended 31 December 2025, the Group recorded net impairment charges of $218 million relating to product, marketing and distribution rights and net impairment charges of $12 million relating to other intangibles. 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 individual asset 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 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.
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 (i) significant judgement made by management when determining the recoverable amount of the Group’s individual assets or CGUs (ii) high degree of auditor judgement, subjectivity, and effort in performing procedures and evaluating significant assumptions in management’s cash flow projections related to the probability of technical and regulatory success, market volume, share and pricing (to derive peak year sales), and sales erosion curves following patent expiry and (iii) the audit effort involved the use of professionals with specialised skill and knowledge.
56
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 valuation of the recoverable amounts of the Group’s individual assets or CGUs, including controls over the significant assumptions. These procedures also included, among others (i) testing management’s process for identifying indicators of impairment and for developing the estimated recoverable amounts (ii) evaluating the appropriateness of the methodology used by management to estimate the recoverable amounts (iii) testing the completeness and accuracy of underlying data used in the models and (iv) evaluating the reasonableness of the significant assumptions used by management related to the probability of technical and regulatory success, with the assistance of professionals with specialised skill and knowledge, and market volume, share and pricing (to derive peak year sales), and sales erosion curves following patent expiry. Evaluating management’s assumptions related to the probability of technical and regulatory success, market volume, share and pricing (to derive peak year sales), and sales erosion curves following patent expiry involved evaluating whether the assumptions used by management were reasonable considering 1) consistency with external market and industry data and benchmarks 2) performing comparisons of current and past long term forecasts and 3) performing comparisons of management’s probability of technical and regulatory success benchmarks to actual trial and regulatory success rates for the past three years.
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 2025 the Group held legal provisions of $376 million and disclosed the more significant legal matters. Provisions are recognised when there is a legal or constructive present obligation as a result of a past event, 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 (i) the significant judgement made by management when assessing whether an adverse outcome is probable and can be estimated reliably (ii) a high degree of auditor judgement, subjectivity and effort in performing procedures and evaluating management’s assessment of the legal provisions and disclosures of contingent liabilities and (iii) 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, and related 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.
57
Valuation of defined benefit obligations in the United Kingdom (“UK”)
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 2025 the Group had defined benefit obligations of $4,767 million in the UK. Qualified independent actuaries, engaged by management, have updated the actuarial valuations under IAS 19 for the major defined benefit plans operated by the Group to 31 December 2025. 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 include mortality, inflation and discount rates for the UK.
The principal considerations for our determination that performing procedures relating to the valuation of defined benefit obligations in the UK is a critical audit matter are (i) the significant judgement made by management, including the use of management’s experts, when determining the present value of defined benefit obligations (ii) a high degree of auditor judgement, subjectivity and effort in performing procedures and evaluating management’s significant assumptions related to the mortality, inflation and discount rates, and (iii) 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 valuation of the defined benefit obligations, including controls over the significant assumptions. These procedures also included, among others, (i) testing the completeness and accuracy of the data provided by management and (ii) the involvement of professionals with specialised skill and knowledge to assist in evaluating the reasonableness of management’s estimate by (a) developing an independent estimate of the defined benefit obligations for the UK and (b) comparing the independent estimate to management’s estimate. Developing the independent estimate involved independently determining mortality, inflation and discount rate assumptions by evaluating the specifics of the plan and, where applicable, considering national information, and consistency with external market and industry data.
10 February 2026
We have served as the Group’s auditor since 2017.
58
ITEM 19. EXHIBITS(1)
1.1 | | |
|
|
|
2.1 |
| |
|
|
|
4.1 |
| |
|
|
|
4.2 |
| |
|
|
|
4.3 | ||
|
|
|
8.1 |
| |
|
|
|
11.2 | ||
12.1 |
| |
|
|
|
12.2 |
| |
|
|
|
13.1 |
| |
|
|
|
15.1 |
| |
|
|
|
15.2 |
| Consent of PricewaterhouseCoopers LLP, independent registered public accounting firm. |
|
|
|
15.3 |
| |
|
|
|
15.4 | ||
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 2025 is not deemed to be filed as part of this Annual Report on Form 20-F. |
59
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/ Matthew Bowden | |
|
| Name: | Matthew Bowden |
|
| Title: | Company Secretary |
|
| ||
| |||
February 24, 2026 |
| ||
60
F-1
Consolidated Statement of Comprehensive Income
for the year ended 31 December
| | 2025 | | 2024 | | 2023 |
| ||
Notes | $m | $m | $m |
| |||||
– Product Sales | 2 | | | | |||||
– Alliance Revenue | 2 | | | | |||||
Product Revenue | | | | ||||||
Collaboration Revenue | 2 | | | | |||||
Total Revenue | | | | ||||||
Cost of sales | ( | ( | ( | ||||||
Gross profit | | | | ||||||
Distribution expense | ( | ( | ( | ||||||
Research and development expense | 3 | ( | ( | ( | |||||
Selling, general and administrative expense | 3 | ( | ( | ( | |||||
Other operating income and expense | 3 | | | | |||||
Operating profit | | | | ||||||
Finance income | 4 | | | | |||||
Finance expense | 4 | ( | ( | ( | |||||
Share of after tax losses in associates and joint ventures | 12 | ( | ( | ( | |||||
Profit before tax | | | | ||||||
Taxation | 5 | ( | ( | ( | |||||
Profit for the period | | | | ||||||
Other comprehensive income: | |||||||||
Items that will not be reclassified to profit and loss: | |||||||||
Remeasurement of the defined benefit pension liability | 22 | | | ( | |||||
Net gains on equity investments measured at fair value through Other comprehensive income | | | |||||||
Fair value movements related to own credit risk on bonds designated as fair value through profit or loss | – | | ( | ||||||
Tax (expense)/income on items that will not be reclassified to profit and loss | 5 | ( | ( | | |||||
| | ( | |||||||
Items that may be reclassified subsequently to profit and loss: | |||||||||
Foreign exchange arising on consolidation | 23 | | ( | | |||||
Foreign exchange arising on designated liabilities in net investment hedges | 23 | ( | | ||||||
Fair value movements on cash flow hedges | ( | | |||||||
Fair value movements on cash flow hedges transferred to profit and loss | ( | | ( | ||||||
Fair value movements on derivatives designated in net investment hedges | 23 | | | ||||||
Gains/(costs) of hedging | ( | ( | |||||||
Tax (expense)/income on items that may be reclassified subsequently to profit and loss | 5 | ( | | ( | |||||
| ( | | |||||||
Other comprehensive income/(expense) for the period, net of tax | ( | | |||||||
Total comprehensive income for the period | | | | ||||||
Profit attributable to: | |||||||||
Owners of the Parent | | | | ||||||
Non-controlling interests | 26 | | | | |||||
Total comprehensive income attributable to: | |||||||||
Owners of the Parent | | | |||||||
Non-controlling interests | 26 | | | ||||||
Basic earnings per $ | 6 | $ | $ | $ | |||||
Diluted earnings per $ | 6 | $ | $ | $ | |||||
Weighted average number of Ordinary Shares in issue (millions) | 6 | | | ||||||
Diluted weighted average number of Ordinary Shares in issue (millions) | 6 | | | ||||||
Dividends declared and paid in the period | 25 | | | |
All activities were in respect of continuing operations.
$m means millions of US dollars.
F-2
Consolidated Statement of Financial Position
at 31 December
| | 2025 | 2024 |
| |||
Notes | $m | $m |
| ||||
Assets | |||||||
Non-current assets | |||||||
Property, plant and equipment | 8 | | | ||||
Right-of-use assets | 9 | | | ||||
Goodwill | 10 | | | ||||
Intangible assets | 11 | | | ||||
Investments in associates and joint ventures | 12 | | | ||||
Other investments | 13 | | | ||||
Derivative financial instruments | 14 | | | ||||
Other receivables | 15 | | | ||||
Income tax receivable | 5 | | – | ||||
Deferred tax assets | 5 | | | ||||
| | ||||||
Current assets | |||||||
Inventories | 16 | | | ||||
Trade and other receivables | 17 | | | ||||
Other investments | 13 | | | ||||
Derivative financial instruments | 14 | | | ||||
Income tax receivable | 5 | | | ||||
Cash and cash equivalents | 18 | | | ||||
| | ||||||
Total assets | | | |||||
Liabilities | |||||||
Current liabilities | |||||||
Interest-bearing loans and borrowings | 19 | ( | ( | ||||
Lease liabilities | 9 | ( | ( | ||||
Trade and other payables | 20 | ( | ( | ||||
Derivative financial instruments | 14 | ( | ( | ||||
Provisions | 21 | ( | ( | ||||
Income tax payable | 5 | ( | ( | ||||
( | ( | ||||||
Non-current liabilities | |||||||
Interest-bearing loans and borrowings | 19 | ( | ( | ||||
Lease liabilities | 9 | ( | ( | ||||
Derivative financial instruments | 14 | – | ( | ||||
Deferred tax liabilities | 5 | ( | ( | ||||
Retirement benefit obligations | 22 | ( | ( | ||||
Provisions | 21 | ( | ( | ||||
Income tax payable | 5 | ( | ( | ||||
Other payables | 20 | ( | ( | ||||
( | ( | ||||||
Total liabilities | ( | ( | |||||
Net assets | | | |||||
Equity | |||||||
Capital and reserves attributable to equity holders of the Company | |||||||
Share capital | 24 | | | ||||
Share premium account | | | |||||
Capital redemption reserve | | | |||||
Merger reserve | | | |||||
Other reserves | 23 | | | ||||
Retained earnings | 23 | | | ||||
| | ||||||
Non-controlling interests | 26 | | | ||||
Total equity | | |
The Financial Statements from pages 125 to 196 were approved by the Board and were signed on its behalf by
Pascal Soriot | Aradhana Sarin |
Director | Director |
10 February 2026 |
F-3
Consolidated Statement of Changes in Equity
for the year ended 31 December
| | Share | Capital | | | | | Total | | Non- | |
| |||||||
Share | premium | redemption | Merger | Other | Retained | attributable | controlling | Total |
| ||||||||||
capital | account | reserve | reserve | reserves | earnings | to owners | interests | equity |
| ||||||||||
$m | $m | $m | $m | $m | $m | $m | $m | $m |
| ||||||||||
At 1 January 2023 |
| | | | | | ( | | | | |||||||||
Profit for the period | – | – | – | – | – | | | | | ||||||||||
Other comprehensive income1 |
| – | – | – | – | – | | | – | | |||||||||
Transfer to Other reserves2 |
| – | – | – | – | ( | | – | – | – | |||||||||
Transactions with owners |
| ||||||||||||||||||
Dividends (Note 25) |
| – | – | – | – | – | ( | ( | – | ( | |||||||||
Dividends paid to non-controlling interests (Note 25) | – | – | – | – | – | – | – | ( | ( | ||||||||||
Issue of Ordinary Shares |
| | | – | – | – | – | | – | | |||||||||
Share-based payments charge for the period (Note 29) |
| – | – | – | – | – | | | – | | |||||||||
Settlement of share plan awards | – | – | – | – | – | ( | ( | – | ( | ||||||||||
Net movement |
| | | – | – | ( | | | | | |||||||||
At 31 December 2023 |
| | | | | | | | | | |||||||||
Profit for the period |
| – | – | – | – | – | | | | | |||||||||
Other comprehensive expense1 |
| – | – | – | – | – | ( | ( | ( | ( | |||||||||
Transfer to Other reserves2 |
| – | – | – | – | | ( | – | – | – | |||||||||
Transactions with owners |
| ||||||||||||||||||
Dividends (Note 25) |
| – | – | – | – | – | ( | ( | – | ( | |||||||||
Dividends paid to non-controlling interests (Note 25) | – | – | – | – | – | – | – | ( | ( | ||||||||||
Issue of Ordinary Shares |
| – | | – | – | – | – | | – | | |||||||||
Changes in non-controlling interests | – | – | – | – | – | – | – | | | ||||||||||
Movement in shares held by Employee Benefit Trusts2 | – | – | – | – | ( | – | ( | – | ( | ||||||||||
Share-based payments charge for the period (Note 29) |
| – | – | – | – | – | | | – | |