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REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 |
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Title of Each Class |
Trading Symbol(s) |
Name of Each Exchange On Which Registered | ||
1 ⁄4 pence |
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Ordinary Shares of Par value 31 1 ⁄4 pence each |
† |
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. |
U.S. GAAP ☐ |
by the International Accounting Standards Board ☒ |
Other |
☐ |
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TABLE OF CONTENTS
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Pursuant to Rule 12b-23(a) of the Securities Exchange Act of 1934, as amended, the information for GSK plc’s Form 20- F for the year ended December 31, 2022 as set out below is being incorporated by reference from the “GSK Annual Report 2022” included as exhibit 15.2 to this Form 20-F dated and submitted on March 10, 2023 (the “GSK Annual Report 2022”).
All references in this Form 20-F to the “Group,” “GSK,” “we” or “our” mean GSK plc and its subsidiaries; the “company” means GSK plc.
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.
In addition to the information set out below, the information set forth under the headings “Cautionary statement regarding forward-looking statements” on page 317, “Directors’ Report” on page 130, “Directors’ statement of responsibilities” on pages 166 and 167, “Share capital and control” on pages 296 and 297, “Financial calendar 2023”, “Results announcements”, “Financial reports” and “Annual General Meeting 2023” on page 299, “Registrar” on page 302, “ADS Depositary”, “Donating shares to Save the Children”, “Contacts” and “Share scam alert” on page 303, “Section 13(r) of the Exchange Act” on page 305 and “Glossary of terms” on page 315 in each case of the GSK Annual Report 2022 is incorporated by reference.
Notice regarding limitations on Director Liability under English Law
Under the UK Companies Act 2006, a safe harbour limits the liability of Directors in respect of statements in and omissions from certain portions of the GSK Annual Report 2022 incorporated by reference herein, namely “Directors’ Report” (for which see page 130 thereof), the “Strategic Report” (pages 1 to 95 thereof, portions of which are incorporated by reference as described below) and the report on “Remuneration” (pages 132 to 164 portions of which are incorporated by reference as described below). These reports have been drawn up and presented in accordance with, and in reliance upon, English company law. Under English law, the Directors would be liable to the company, but not to any third party, if these sections of the GSK Annual Report 2022 contain errors as a result of recklessness or knowing misstatement or dishonest concealment of a material fact, but would not otherwise be liable.
Portions of the GSK Annual Report 2022 incorporated by reference herein contain references to our website. Information on our website or any other website referenced in the GSK Annual Report 2022 is not incorporated into this Form 20-F and should not be considered to be part of this Form 20-F. We have included any references to the website as an inactive textual reference only.
PART I
| Item 1. | Identity of Directors, Senior Management and Advisers |
Not applicable.
| Item 2. | Offer Statistics and Expected Timetable |
Not applicable.
| Item 3. | Key Information |
| 3.A | [Reserved] |
| 3.B | Capitalization and indebtedness |
Not applicable.
| 3.C | Reasons for the offer and use of proceeds |
Not applicable.
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| 3.D | Risk Factors |
Principal risks and uncertainties
We outline below the principal risks and uncertainties relevant to GSK’s business, financial condition and operations that may affect our performance and ability to achieve our objectives. These are the risks that we believe could cause our actual results to differ materially from expected and historical results.
Operating in the biopharmaceutical sector carries various inherent risks and uncertainties that may affect our business. We must comply with a broad range of laws and regulations which apply to the research and development, manufacturing, testing, approval, distribution, sales, and marketing of pharmaceutical and vaccine products. These affect the cost of product development, the time required to reach the market and the likelihood of doing so successfully on an uninterrupted basis.
As rules and regulations change, government interpretation evolves, and our business activities develop, the nature of a particular risk may also alter. Changes to regulatory regimes may be substantial. Any alteration in, and failure to comply with, applicable laws and regulations could materially and adversely affect our financial results.
Similarly, our global business exposes us to litigation and government investigations, including product liability litigation, patent and antitrust litigation and sales and marketing litigation. Litigation and government investigations, and the related provisions we may make for unfavourable outcomes and increases in related costs such as insurance premiums, could also materially and adversely affect our financial results.
More detail on the status and various uncertainties in our significant unresolved disputes and potential litigation is set out in Note 47, ‘Legal proceedings’ on pages 265 to 267 of the GSK Annual Report 2022, which is incorporated by reference herein.
Patient safety
Risk definition
The risk that GSK, including our third parties, potentially fails to appropriately collect, review, follow up, or report human safety information, including adverse events, from all potential sources or that GSK potentially fails to act on any relevant findings in a timely manner.
Risk impact
GSK will not tolerate an unfavourable benefit-to-risk profile for patients who use our products. As the most important consequence of ineffective pharmacovigilance is the potential for harm to patients, we maintain robust processes for managing human safety information, conducting timely safety signal detection, and ensuring appropriate measures are in place to manage risks to patients. GSK also intends to fully comply with pharmacovigilance and other relevant regulations worldwide. Non-compliance could result in inspection findings, regulatory scrutiny, civil or criminal sanctions and either temporary or permanent loss of product marketing authorisation. We regularly review and respond to all patient safety risks to limit the potential for reputational damage, loss of trust by patients and healthcare providers, product-related litigation, and loss of shareholder confidence.
Context
We are fully accountable for safeguarding patients; our failure to do so effectively could result most importantly in harm to patients, as well as reputational damage and/or product liability litigation. We conduct internal safety surveillance and rely on access to safety information from external sources. Information on the safety and efficacy of our products in humans is collected during clinical development, with more comprehensive information incorporated from real-world use once our products are marketed. There are examples of regulatory agencies using real-world evidence from sources which may not be accessible to the industry to supplement and validate the evidence we use to support the safety and efficacy of our products. There is a potential emerging risk that technology companies or other data custodians may similarly draw and communicate conclusions about the safety of our products based on digital health data collected through their platforms that is inaccessible by either the industry or regulatory agencies.
Our licence to operate depends on our compliance with regulatory requirements worldwide, not only those directly related to patient safety but extending to privacy and information security regulations as well. Regulatory compliance depends on appropriate identification and management of human safety information by all employees and third parties acting on our behalf. We are pursuing innovative solutions to enhance our ability to perform pharmacovigilance, including Artificial Intelligence and Machine Learning technology to augment our capacity to manage increasing volumes of adverse event reports from varied sources, and advancing technical solutions for delivering safety information and risk minimisation measures to patients and health care providers.
The COVID-19 pandemic has had an impact on pharmacovigilance activities by increasing public focus on safety and efficacy of medicines and vaccines, highlighting the importance of robust business continuity planning for uninterrupted safety oversight and regulatory compliance (including the ability to accommodate remote regulatory inspections), and accelerating automation to manage increasing volumes of adverse events.
Product quality
Risk definition
The risk that GSK or our third parties potentially fail to ensure appropriate controls and governance of quality for development and commercial products; compliance with industry practices and regulations in manufacturing and distribution activities; and terms of GSK product licenses and supporting regulatory activities.
Risk impact
A failure to ensure product quality could have far-reaching implications for patient safety, cause product launch delays, drug shortages or product recalls, and have regulatory, legal, and financial consequences. These could materially and adversely affect GSK’s reputation and financial results.
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Context
The external environment for product quality remains challenging, with increased cyber-attacks and data breaches across the industry. Cyber-attacks remain a key risk to the integrity of product quality data and its audit trail. We met our commitments for the 2021 European Medicines Agency (EMA) requirements for licensing of Medical Devices. We continue to plan for the deployment of the New Annex 1 guidance for the manufacture of Sterile Medicinal products which was published in September 2022 and sets an expectation for compliance by August 2023. We are actively managing this implementation in the context of global equipment and component supply chain constraints affecting the industry. We are increasingly applying advanced digital technologies and insights to drive scientific excellence to enhance the development, manufacture and testing of our products. For example, we use new electronic documentation systems and advanced laboratory information management tools. Our quality organisations are aligned to make sure quality procedures and governance can facilitate the new company strategy. Pre-pandemic levels of on-site inspections have resumed, and we continue to take steps to ensure our inspection readiness.
Financial controls and reporting
Risk definition
The risk that GSK fails to comply with current tax laws, fails to report accurate financial information in compliance with accounting standards and applicable legislation, or incurs significant losses due to treasury activities.
Risk impact
Non-compliance with existing or new financial or new ESG reporting and disclosure requirements, or changes to the recognition of income and expenses, could expose GSK to litigation and regulatory action and could materially and adversely affect our financial results. Failure to comply with changes in the substance or application of the laws governing transfer pricing, dividends, tax credits and intellectual property could also materially and adversely affect our financial results. Failure to comply with applicable sanctions laws and regulations could result in GSK being investigated by relevant government agencies and authorities and/or in legal proceedings against us. Government investigations and litigation, can be unpredictable and regardless of their outcome, may be costly, require significant management attention, and damage our reputation. Inconsistent application of treasury policies, transactional or settlement errors, or counterparty defaults could lead to significant losses.
Context
We are required by the laws of various jurisdictions to publicly disclose our financial results and events that could materially affect the Group’s financial results. Regulators routinely review the financial statements of listed companies for compliance with new, revised, or existing accounting and regulatory requirements. We believe that we comply with the appropriate regulatory requirements concerning our financial statements and the disclosure of material information, including any transactions relating to business restructuring such as acquisitions and divestitures. However, should we be subject to an investigation into potential non-compliance with accounting and disclosure requirements, this could lead to restatements of previously reported results and significant penalties.
Our Treasury group deals daily in high value transactions, mostly foreign exchange, and cash management transactions. These transactions involve market volatility and counterparty risk. The Group’s effective tax rate reflects the locations of our activities and the value they generate, which determine the jurisdictions in which profits arise and the applicable tax rates.
These may be higher or lower than the UK statutory rate and may reflect regimes that encourage innovation and investment in RD by providing tax incentives which, if changed, could affect GSK’s tax rate. In addition, the worldwide nature of our operations means that our cross-border supply routes, necessary to ensure supplies of medicines and vaccines, can result in conflicting claims from tax authorities as to the profits to be taxed in individual countries. This can lead to double taxation, with profits taxed in more than one country. The complexity of tax regulations also means that we may occasionally disagree with tax authorities on the technical interpretation of a particular area of tax law. The tax charge included in our financial statements is our best estimate of tax liability pending any audits by tax authorities. We expect there to be a continued focus on tax reform, driven by initiatives by the OECD and the EC to address the tax challenges arising from digitalisation of the economy. Together with domestic initiatives around the world, these may result in significant changes to established tax principles and an increase in tax authority disputes. Regardless of their merit or outcomes, these may be costly, divert management attention and adversely impact our reputation and relationship with key stakeholders. Laws, regulations, orders and other measures restrict dealings with certain countries, governments, government officials, entities, individuals, use of financial institutions and movement of funds. Circumvention of sanctions and export controls can be a criminal offence and GSK has a zero tolerance policy for breaches of its sanctions obligations. While we believe the Group complies with all applicable sanctions in all material respects, such laws are complex and continue to evolve rapidly.
Anti-bribery and corruption (ABAC)
Risk definition
The risk that GSK or our third parties potentially fail to comply with applicable laws, regulations, or internal requirements and to ensure appropriate controls and governance over bribery and corruption in business activities.
Risk impact
Failure to mitigate this risk could expose GSK and associated persons to governmental investigation, regulatory action, and civil and criminal liability. It may compromise GSK’s ability to supply its products under certain government contracts. In addition, failure to prevent bribery or corruption could have substantial implications for GSK’s reputation and the credibility of senior leaders. It might erode investor confidence in our governance, risk management and future performance, and have a consequential negative impact on share performance. It could also lead to the imposition of significant financial penalties and the imposition of additional reporting obligations.
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Context
There continues to be a strong enforcement appetite for foreign bribery investigations and prosecutions, with a particular focus on the conduct of multinational companies wherever they operate. Financial penalties handed down in proven corruption cases are often very significant.
Disruption to global supply chains and the commercial pressures caused by higher than usual inflation rates are likely to increase the risks of bribery and corruption in certain contexts.
However, greater transparency and collaboration among enforcement authorities, advances in technology and the use of data analytics are providing better platforms to streamline processes and detect potential issues.
Commercial practices
Risk definition
The risk that GSK or our third parties potentially engage in commercial activities that fail to comply with laws, regulations, industry codes, and internal controls and requirements.
Risk impact
Failure to engage in activities that are consistent with the letter and spirit of the law, industry regulations, or the Group’s requirements relating to sales and promotion of medicines and vaccines; with appropriate interactions with healthcare professionals (HCPs), organisations and patients; with legitimate and transparent transfers of value; and with pricing and competition (or antitrust) regulations in commercial practices, including trade channel activities and business tendering, could materially and adversely affect our ability to deliver our strategy and long-term priorities. Additionally, it may result in incomplete awareness of the risk/benefit profile of our products and possibly suboptimal treatment of patients and consumers; governmental investigation, regulatory action and legal proceedings brought against the Group by governmental and private plaintiffs which could result in government sanctions, and criminal and/or financial penalties. Any practices that are found to be misaligned with our values and expectations could also result in reputational harm and dilute the trust established with external stakeholders.
Context
We operate in a highly regulated and extremely competitive biopharma industry, amongst peers who make significant product innovations and technical advances and intensify price competition. Additional external factors impacting our business operations include the ongoing effects of the COVID-19 global pandemic, access limitations to our customers, macroeconomic inflationary dynamics, and pricing pressure across markets. To achieve our strategic objectives, we must continue to develop commercially viable new products and deliver additional uses for existing products that address the needs of patients, consumers, HCPs and payers. Financially, new products/indications carry with them an uncertainty with regards to future success. Product development is costly, lengthy, and uncertain, and carries with it the potential for failure at any stage. Even after successful product development, we face challenges in how we launch, and our competitors’ products or pricing strategies could render our assets less competitive. We support product innovation through our continued focus on both in-person and virtual engagement, with a constant focus on our patient.
Once we have an approved medicine or vaccine, it is our obligation to provide important information to the healthcare community in various ways, always in a responsible, legal, and ethical manner. Appropriate product promotion ensures HCPs have access to the information they need, that patients and consumers have the facts about the medicines and vaccines they require, and that products are prescribed, recommended, or used in a manner that provides healthcare benefit. We are committed to the ethical and responsible commercialisation of our products in support of our purpose to improve the quality of human life and get ahead of disease together.
Scientific and patient engagement
Risk definition
The risk that GSK or our third parties potentially fail to engage externally to gain insights, educate and communicate on the science of our medicines and associated disease areas, and provide grants and donations in a legitimate and transparent manner compliant with laws, regulations, industry codes and internal controls and requirements.
Risk impact
Without controls in place, the risk could result in real, perceived, or disguised promotion including off-label and prior- authorisation promotion, and real or perceived provision of medical advice. This in turn could lead to criminal investigations and penalties, civil litigation, or competitor complaints. At the same time, if we do not engage fully and appropriately, this could result in patient harm, failure to advance science and innovation, reputational damage, and financial loss. Such consequences may reduce the trust of the public, patients, healthcare professionals, payers, regulators and governments.
Context
Scientific and patient engagements are diverse non-promotional activities directed at healthcare professionals, patients, payers, and external stakeholders. Such engagements aim to improve patient care through the exchange or provision of knowledge on the use of our products and related diseases. Scientific and patient engagement with external stakeholder groups is vital to GSK, as a research-based biopharma company that is ambitious for patients and is necessary to advance science and medicine.
We expect our activities to be scientifically sound and accurate, conducted ethically and transparently, and compliant with applicable codes, laws, and regulations. There are many industry and local codes and laws and other regulations that apply (such as Privacy, Data integrity). That means measured risk-taking, rooted in sound ethical considerations, and principles-based decision-making, training, communication, and monitoring of such activities are key to managing the risk and enabling full and appropriate engagement.
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Data ethics and privacy
Risk definition
The risk that GSK or our third parties potentially fail to ethically collect; use; re-use through artificial intelligence, data analytics or automation; secure; share and destroy personal information in accordance with laws, regulations, and internal controls and requirements.
Risk impact
Non-compliance with data privacy laws globally could lead to harm to individuals and GSK. It could also damage trust between GSK and individuals, communities, business partners and government authorities. Many countries have increased the enforcement powers of their data protection authorities by allowing them to impose significant fines, impact cross-border data flows, or temporarily ban data processing. Many new national laws also enable individuals to bring collective legal actions against companies such as GSK for failure to follow data privacy laws.
Context
Data protection and privacy legislation is diverse, with limited global harmonisation or simplification. It is challenging for multinationals to standardise their approach to compliance with data privacy laws. Governments are enforcing compliance with data protection and privacy laws more rigorously. The approach and focus of data protection and privacy regulators also differs between regions and countries, which further creates challenges for global organisations seeking to implement a single harmonised global privacy programme.
Increases in the volume of data processed and advances in technology have resulted in a greater focus on data governance and the ethical use of personal information, over and above compliance with data privacy laws. Companies seeking to foster innovation in artificial intelligence and other new technologies are faced with evolving decisions from global policymakers on how best to promote trust in these systems and avoid unintended outcomes or harmful impacts.
Additionally, there are a number of emerging laws concerning the localisation of data, restrictions on international transfers and data security, which are changing existing frameworks that GSK has previously relied upon. This increasing trend for data sovereignty affects our ability to drive medical innovation and to effectively operate internationally.
Research practices
Risk definition
The risk that GSK or our third parties potentially fail to adequately conduct ethical and credible pre-clinical and clinical research, collaborate in research activities compliant with laws, regulations, and internal controls and requirements.
Risk impact
The potential impacts of the risk include harm to human subjects, reputational damage, failure to obtain the necessary regulatory approvals for our products, governmental investigation, legal proceedings brought against the GSK by governmental and private plaintiffs (product liability suits and claims for damages), loss of revenue due to inadequate patent protection or inability to supply our products, and regulatory action such as fines, penalties, or loss of product authorisation. Poor data integrity and governance could compromise GSK’s RD efforts and negatively impact our reputation. Any of these could materially and adversely affect our financial results and damage the trust of patients and customers.
Context
Research involving animals can raise ethical concerns. In many cases, however, research involving animals is the only way to investigate the effects of a potential new medicine in a living body other than in humans. Animal research provides critical information about the causes and mechanisms of diseases and therefore remains a vital part of our research. We continually seek ways in which we can minimise our use of animals in research, development, and testing, while complying with regulatory requirements and reducing the impact on the animals used. Human subject research is critical to assessing and demonstrating the safety and efficacy of our investigational products or further evaluating our products once they have been approved. This research includes clinical trials in healthy volunteers and patients and adheres to regulations and high ethical, medical, and scientific standards. We disclose the results of this research externally regardless of whether they reflect positively or negatively on our products, so that the scientific community can learn from the outcomes of our research. We also work with human biological samples which are fundamental to the discovery, development, and safety monitoring of our products.
We are committed to managing human biological samples in accordance with relevant laws, regulations, and ethical principles, and in a manner that respects the interests of sample donors. Data is pivotal to our RD strategy, and we are maximising the use of data to serve patients. Governing our data in accordance with relevant laws, regulations, contractual obligations, expectations, and our culture across privacy, information security, and data integrity is essential.
We use a wide variety of biological materials in the discovery, research, and development of our assets. Through the Convention on Biological Diversity (CBD) and the Nagoya Protocol, the international community has established a global framework regulating access to, and use of, genetic resources of non-human origin in research and development. We support the principles of access to, and benefit-sharing of, genetic resources as outlined in the CBD and the Nagoya Protocol. We also recognise the importance of appropriate, effective, and proportionate implementation measures at national and regional levels.
Environment, health, and safety (EHS)
Risk definition
The risk that GSK or our third parties potentially fail to ensure appropriate controls and governance of the organisation’s assets, facilities, infrastructure, and business activities, including execution of hazardous activities, handling of hazardous materials, or release of substances harmful to the environment that disrupts supply or harms employees, third parties or the environment.
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Risk impact
Failure to manage EHS risks could lead to significant harm to people, the environment and the communities in which we operate, fines, inability to meet stakeholder expectations and regulatory requirements, litigation or regulatory action, and damage to the company’s reputation, which could materially and adversely affect our financial results.
Context
GSK is subject to the health, safety and environmental laws of various jurisdictions. These laws impose duties to protect people, the environment and the communities in which we operate.
Information security
Risk definition
The risk that GSK or our third parties potentially fail to ensure appropriate controls and governance over unauthorised access, disclosure, theft, unavailability or corruption of GSK’s information, key systems or technology infrastructure.
Risk impact
Failure to adequately protect our information and systems may cause harm to our patients, workforce and customers, disruption to our business and/or loss of commercial or strategic advantage, regulatory sanction or damage to our reputation.
Context
The external environment continues to be extremely challenging, making it hard to keep pace with increasingly sophisticated cyber threats. This is due to many factors including increased geopolitical conflict and digital nationalism, rising frequency and severity of data breaches and growing capability and sophistication of bad actors and cyber criminals. GSK’s business relies on operating a highly connected information network of internal and external systems, which hold confidential research and development, manufacturing, commercial, workforce and financial data. This means that our systems and information have been and will continue to be the target of cyber-attacks. Acceleration in the use of digital, data and analytics and cloud computing capabilities to drive GSK’s pipeline and performance requires us to continuously adapt and strengthen our controls and defensive capabilities. GSK also relies on third-party contractors, partners and suppliers who face similar cyber threats and this continues to be a vector of risk to manage as well.
Supply continuity
Risk definition
The risk that GSK or our third parties potentially fail to deliver a continuous supply of compliant finished product or respond effectively to a crisis incident in a timely manner to recover and sustain critical supply operations.
Risk impact
We recognise how important the continuity of supply of our products is to the patients who rely on them. Supply disruption can lead to:
| • | Product shortages and product recalls |
| • | Regulatory intervention |
| • | Reputational harm |
| • | Lost sales revenue |
Consequently, we need sophisticated end-to-end supply chain management with robust crisis management and business continuity plans in place to respond.
Context
We run our supply chains in a continually evolving, highly-regulated environment. There is no single set of global regulations which governs the manufacture and distribution of medicines, and we must adhere to the requirements in all those markets in which we licence, sell or manufacture our products. We rely upon our internal Quality Management System and our Internal Control Framework to ensure we continue to preserve our licence to operate.
Our complex end-to-end supply chains often involve third-party suppliers, from Active Pharmaceutical Ingredient (API) manufacturers and raw material suppliers through to Third-Party Logistics Providers and contract engineering firms. We embed integrated risk management into our sourcing and day to day business processes, alongside our Third-Party Oversight programme.
External factors continued to challenge supply continuity in 2022. In the early part of the year COVID-19 continued to disrupt our sourcing of biosciences materials across our Medicines and Vaccines supply chains (e.g. vials, syringes and single-use systems components). The Ukraine conflict has resulted in supply disruption to the region. To manage these disruptions, we deployed bespoke de-risking plans using crisis and continuity plans to manage the detail and mitigate the risk of supply continuity problems, e.g. by dual sourcing of materials or re-routing of shipments to avoid conflict zones. Keeping our patients supplied with their medicines is our priority.
New technology and modality platforms within supply chains are changing the requirements for the skillsets of people working in this field. We have implemented a new Chemistry, Manufacturing and Controls Operating Model in 2022. This brings cross-fertilisation of talent focus on the skills needed for the future for innovative manufacturing.
Industrial relations are also a current risk to supply continuity, with the threat of industrial action being averted in our UK manufacturing sites through successful dialogue with unions. Continued business monitoring is in place to assess the risk of the spread of industrial relations challenges resulting from global cost of living pressures.
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Climate-related risks
Risk definition
Failure in the management of:
| • | Physical climate and environmental risks; |
| • | Current and future regulatory requirements for environmental policies and taxes; |
| • | Delivery and performance of management environmental objectives; |
leading to: reduced supply chain resilience; product life cycle management issues, loss of trust/reputation with employees, investors, customers, regulators and other stakeholders; increased costs; loss of sales or market access; negative impacts on the environment.
Risk impact
We recognise that the way we respond to climate change and manage environmental risks affects our ability to supply products to patients and consumers and could lead to harm to the environment and our reputation. For example, risks from increasing levels of water stress could lead to interruptions to supply of water to our sites and third-party supply sites, and increasing frequency of extreme weather events may cause disruptions to our and third-party supply sites, affecting our ability to supply products to patients and consumers.
Current and future regulatory responses to address climate change may result in increased costs and compliance obligations, including restricting our ability to manufacture certain products and/or requiring us to find alternatives for the manufacture of certain products. For example, regulations governing the use of high global warming potential (GWP) substances are being updated in the EU and were recently updated in the US, which will lead to increasing costs and could restrict GSK’s ability to manufacture its metered dose inhaler products that use a high GWP propellant. In addition, our ability to meet our target of reducing carbon emissions by 80% and 90% by 2030 and 2045, respectively, is based on our investment in an RD programme to reduce greenhouse gas emissions from metered dose inhalers, including successful clinical trials and obtaining regulatory approvals. Limitations in the jurisdictions in which we operate may also limit our access to renewable energy sources and electric vehicles, which may affect our ability to achieve reductions in emissions across our operations. Failure to meet fast-evolving regulatory requirements and stakeholder expectations could also result in litigation or regulatory actions or lead to increasing demand for low carbon medicines and vaccines, affecting demand for our products, which may have a material adverse impact on our financial results and longer term loss of trust, undermining the credibility of the company.
Context
It is increasingly understood that the interconnected effects of climate change, nature loss, and society’s impact on both are influencing human health. Internal and external expectations for companies to address their impact on the environment are increasing, as are the effects of climate change on operational resilience, in regard to access to energy, water and the natural resources used in products, along with potential cost increases from any regulatory changes or environmental taxes, such as carbon taxes in countries where GSK manufacturers and sources goods from third parties.
Risks associated with COVID-19
The potential impact of the COVID-19 pandemic on GSK’s trading performance and all its principal risks is continually assessed. While GSK was encouraged by the uptake of its vaccines and medicines in 2022, the pandemic remains a dynamic ongoing risk, with the World Health Organization continuing to monitor the emergence of new variants. The current rate of infection is predominantly driven by the circulation of the BA.5 subvariant and its descendent lineages, which are still the dominant subvariants of Omicron globally. While COVID-19 vaccines are being updated with Omicron variants to provide broader immunity against circulating and emerging variants, these subvariants and potential future variants of concern could potentially impact GSK’s trading results, clinical trials, supply continuity and its employees materially.
Risks relating to the separation of the Consumer Healthcare business
On 18 July 2022, GSK separated its Consumer Healthcare business from the Group to form Haleon, an independent listed company. Following the demerger, GSK continues to hold 6.0% of the shares of Haleon (including shares received by GSK’s consolidated ESOP trusts) and 7.5% remains held by certain Scottish Limited Partnerships set up to provide collateral for a funding mechanism pursuant to which GSK will provide additional funding for its UK defined benefit pension schemes.
The realisation of the anticipated benefits of the separation is subject to a number of factors, including many which are outside the control of the Group. There can be no guarantee that the anticipated benefits of the separation will be realised in full or in part, or as to the timing of when any such benefits may be realised. In addition, even if the anticipated benefits of the separation are realised, the market price of the GSK shares may not reflect such benefits.
Following the separation, GSK’s business is smaller and less diversified than it was prior to the separation, with greater relative exposure to the global pharmaceuticals and vaccines markets and the risks associated with such markets. As a result of the reduction in GSK’s size, should any part of its business underperform, this may have a greater adverse impact on the Group than would have been the case prior to the separation.
In addition, the value of GSK’s retained investment in Haleon will be affected by changes in the market price of Haleon shares, and may decrease in value as a result of any decrease in the market price of Haleon shares.
The failure of GSK to realise any of the anticipated benefits of the separation, including the value of its retained investment in Haleon, could have a material adverse impact on the Group’s business, financial condition, results of operations and/or prospects.
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| Item 4. | Information on the Company |
| 4.A | History and development of the company |
The information set forth under the heading:
| • | “About GSK” on page 317; |
| • | “Head Office and Registered Office” on the outside back cover; |
| • | “Note 41 – Acquisitions and disposals” on pages 237 to 241; and |
| • | “Demerger and Share Consolidation” on page 296 |
of the GSK Annual Report 2022 is incorporated herein by reference.
The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. The address of that site is http://www.sec.gov. GSK’s Internet address is gsk.com.
| 4.B | Business overview |
| • | See Item 3.D “Risk factors” above. |
In addition, the information set forth under the headings:
| • | “Ahead Together” on page 1 (excluding the paragraph under the heading “We’re confident in our future”) |
| • | “Chair’s statement” on pages 4 and 5 (excluding (i) the seventh paragraph on page 4 and (ii) the first paragraph under “Targets and governance” on page 5); |
| • | “CEO’s statement” on pages 6 and 7 (excluding the heading “Strong 2022 performance increases confidence in delivering growth through 2026 and beyond” and the paragraphs thereunder on page 6); |
| • | “Business model” on pages 8 and 9 (excluding (i) the second paragraph under “Performance” on page 9 and (ii) the last paragraph at the bottom of page 9); |
| • | “Our culture and people” on pages 10 and 11; |
| • | “Our external environment” on pages 12 to 14; |
| • | “Research and Development” on pages 15 to 28; |
| • | “Performance: Vaccines” on pages 29 to 32; |
| • | “Performance: Specialty Medicines” on pages 33 to 37 (excluding the fifth bullet under “Drivers of growth across the portfolio” on page 35); |
| • | “Performance: General Medicines” on pages 38 to 40; |
| • | “Responsible business” on pages 41 to 50 (excluding the second paragraph under the heading “2022 ESG Performance Rating” on page 42); |
| • | “Climate-related financial disclosures” on pages 55 to 63 (excluding the third sentence in Note 2 to the table on page 62); |
| • | “Note 6 – Turnover and segment information” on pages 195 to 197; |
| • | “Note 41 – Acquisitions and disposals” on pages 237 to 241; |
| • | “Pharmaceutical products, competition and intellectual property” on pages 282 and 283; and |
| • | “Vaccines products, competition and intellectual property” on page 284 |
of the GSK Annual Report 2022 is incorporated herein by reference.
| 4.C | Organizational structure |
The information set forth under the headings:
| • | “Note 46 – Principal Group companies” on page 264; and |
| • | “Group companies” on pages 307 to 314 |
of the GSK Annual Report 2022 is incorporated herein by reference.
| 4.D | Property, plant and equipment |
The information set forth under the heading “Property, plant and equipment” under “Financial position and resources” in Item 5.A of this annual report on Form 20-F is incorporated herein by reference.
The information set forth under the headings:
| • | “PPE, intangible asset and goodwill impairment by segment” and “PPE and intangible asset impairment reversals by segment” within “Note 6 – Turnover and segment information” on page 197; and |
| • | “Note 17 – Property, plant and equipment” on pages 208 and 209 |
of the GSK Annual Report 2022 is incorporated herein by reference.
| Item 4A. | Unresolved Staff Comments |
Not applicable.
| Item 5. | Operating and Financial Review and Prospects |
| 5.A | Operating results |
The information set forth under the heading “Our external environment” on pages 12 to 14 of the GSK Annual Report 2022 is incorporated herein by reference.
9
Table of Contents
The following tables reconcile Total results to Adjusted results. References to the reconciliations on pages 81 to 83 and page 277 of the GSK Annual Report 2022 should be read to refer to the information in these tables.
10
Table of Contents
Adjusted results reconciliation – 31 December 2022
| Total |
Profit from discontinued operations |
Intangible asset amortisation |
Intangible asset impairment |
Major restructuring |
Tranaction related |
Divestments, significant legal and other items |
Adjusted results |
|||||||||||||||||||||||||
| £m | £m | £m | £m | £m | £m | £m | £m | |||||||||||||||||||||||||
| Gross profit from continuing operations |
19,770 | 648 | 102 | 45 | 18 | 20,583 | ||||||||||||||||||||||||||
| Operating profit from continuing operations |
6,433 | 739 | 296 | 321 | 1,750 | (1,388 | ) | 8,151 | ||||||||||||||||||||||||
| Profit before taxation from continuing operations |
5,628 | 739 | 296 | 323 | 1,750 | (1,378 | ) | 7,358 | ||||||||||||||||||||||||
| Profit after taxation from continuing operations |
4,921 | 589 | 232 | 236 | 1,508 | (1,266 | ) | 6,220 | ||||||||||||||||||||||||
| Profit after taxation from discontinued operations |
10,700 | (10,700 | ) | — | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total profit after taxation |
15,621 | (10,700 | ) | 589 | 232 | 236 | 1,508 | (1,266 | ) | 6,220 | ||||||||||||||||||||||
| Profit attributable to shareholders from continuing operations |
4,461 | 589 | 232 | 236 | 1,373 | (1,266 | ) | 5,625 | ||||||||||||||||||||||||
| Profit attributable to shareholders from discontinued operations |
10,495 | (10,495 | ) | — | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total profit attributable to shareholders |
14,956 | (10,495 | ) | 589 | 232 | 236 | 1,373 | (1,266 | ) | 5,625 | ||||||||||||||||||||||
| Basic earnings per share (pence) from continuing operations |
110.8 | p | 14.6 | p | 5.8 | p | 5.9 | p | 34.1 | p | (31.5 | )p | 139.7 | p | ||||||||||||||||||
| Basic earnings per share (pence) from discontinued operations |
260.6 | p | (260.6 | )p | — | — | — | — | — | — | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total Basic earnings per share (pence) |
371.4 | p | (260.6 | )p | 14.6 | p | 5.8 | p | 5.9 | p | 34.1 | p | (31.5 | )p | 139.7 | p | ||||||||||||||||
| Weighted average number of shares (millions) |
4,026 | 4,026 | ||||||||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted gross profit from continuing operations |
| |||||||||||||||||||||||||||||||
| Cost of sales |
(9,554 | ) | 648 | 102 | 45 | 18 | (8,741 | ) | ||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted operating profit from continuing operations |
| |||||||||||||||||||||||||||||||
| Selling, general and administration |
(8,372 | ) | 180 | 13 | 51 | (8,128 | ) | |||||||||||||||||||||||||
| Research and development |
(5,488 | ) | 91 | 296 | 39 | (5,062 | ) | |||||||||||||||||||||||||
| Other operating (expense)/income |
523 | 1,692 | (1,457 | ) | 758 | |||||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted profit before tax from continuing operations |
| |||||||||||||||||||||||||||||||
| Net finance costs |
(803 | ) | 2 | 10 | (791 | ) | ||||||||||||||||||||||||||
| Share of after tax losses of associates and joint ventures |
(2 | ) | (2 | ) | ||||||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted profit after tax from continuing operations |
| |||||||||||||||||||||||||||||||
| Taxation |
(707 | ) | (150 | ) | (64 | ) | (87 | ) | (242 | ) | 112 | (1,138 | ) | |||||||||||||||||||
| The following adjustments are made in arriving at Adjusted profit attributable to shareholders |
| |||||||||||||||||||||||||||||||
| Profit attributable to non-controlling interests from continuing operations |
460 | 135 | 595 | |||||||||||||||||||||||||||||
| Profit attributable to non-controlling interests from discontinued operations |
205 | (205 | ) | — | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total profit attributable to non-controlling interests |
665 | (205 | ) | — | — | — | 135 | — | 595 | |||||||||||||||||||||||
11
Table of Contents
Adjusted results reconciliation – 31 December 2021
| Total results |
Profit from discontinued operations |
Intangible asset amortisation |
Intangible asset impairment |
Major restructuring |
Tranaction related |
Divestments, significant legal and other items |
Adjusted results |
|||||||||||||||||||||||||
| £m | £m | £m | £m | £m | £m | £m | £m | |||||||||||||||||||||||||
| Gross profit from continuing operations |
16,533 | 660 | 102 | 28 | 27 | 17,350 | ||||||||||||||||||||||||||
| Operating profit from continuing operations |
4,357 | 761 | 347 | 424 | 1,143 | (539 | ) | 6,493 | ||||||||||||||||||||||||
| Profit before taxation from continuing operations |
3,599 | 761 | 347 | 426 | 1,143 | (502 | ) | 5,774 | ||||||||||||||||||||||||
| Profit after taxation from continuing operations |
3,516 | 608 | 266 | 347 | 964 | (845 | ) | 4,856 | ||||||||||||||||||||||||
| Profit after taxation from discontinued operations |
1,580 | (1,580 | ) | — | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total profit after taxation |
5,096 | (1,580 | ) | 608 | 266 | 347 | 964 | (845 | ) | 4,856 | ||||||||||||||||||||||
| Profit attributable to shareholders from continuing operations |
3,316 | 608 | 266 | 347 | 723 | (845 | ) | 4,415 | ||||||||||||||||||||||||
| Profit attributable to shareholders from discontinued operations |
1,069 | (1,069 | ) | — | — | |||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total profit attributable to shareholders |
4,385 | (1,069 | ) | 608 | 266 | 347 | 723 | (845 | ) | 4,415 | ||||||||||||||||||||||
| Basic earnings per share (pence) from continuing operations |
82.9 | p | 15.2 | p | 6.6 | p | 8.7 | p | 18.1 | p | (21.2 | )p | 110.3 | p | ||||||||||||||||||
| Basic earnings per share (pence) from discontinued operations |
26.7 | p | (26.7 | )p | — | — | — | — | — | — | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total Basic earnings per share (pence) |
109.6 | p | (26.7 | )p | 15.2 | p | 6.6 | p | 8.7 | p | 18.1 | p | (21.2 | )p | 110.3 | p | ||||||||||||||||
| Weighted average number of shares (millions) |
4,003 | 4,003 | ||||||||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted gross profit from continuing operations |
| |||||||||||||||||||||||||||||||
| Cost of sales |
(8,163 | ) | 660 | 102 | 28 | 27 | (7,346 | ) | ||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted operating profit from continuing operations |
| |||||||||||||||||||||||||||||||
| Selling, general and administration |
(7,070 | ) | 277 | 9 | 35 | (6,749 | ) | |||||||||||||||||||||||||
| Research and development |
(5,019 | ) | 101 | 347 | 45 | 1 | (4,525 | ) | ||||||||||||||||||||||||
| Other operating (expense)/income |
(87 | ) | 1,106 | (602 | ) | 417 | ||||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted profit before tax from continuing operations |
| |||||||||||||||||||||||||||||||
| Net finance costs |
(755 | ) | 2 | 1 | (752 | ) | ||||||||||||||||||||||||||
| Loss on disposal of interest in associates |
(36 | ) | 36 | — | ||||||||||||||||||||||||||||
| Share of after tax losses of associates and joint ventures |
33 | 33 | ||||||||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted profit after tax from continuing operations |
| |||||||||||||||||||||||||||||||
| Taxation |
(83 | ) | (153 | ) | (81 | ) | (79 | ) | (179 | ) | (343 | ) | (918 | ) | ||||||||||||||||||
| The following adjustments are made in arriving at Adjusted profit attributable to shareholders |
| |||||||||||||||||||||||||||||||
| Profit attributable to non-controlling interests from continuing operations |
200 | 241 | 441 | |||||||||||||||||||||||||||||
| Profit attributable to non-controlling interests from discontinued operations |
511 | (511 | ) | — | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total profit attributable to non-controlling interests |
711 | (511 | ) | — | — | — | 241 | — | 441 | |||||||||||||||||||||||
12
Table of Contents
Adjusted results reconciliation – 31 December 2020
| Total results |
Profit from discontinued operations |
Intangible asset amortisation |
Intangible asset impairment |
Major restructuring |
Tranaction related |
Divestments, significant legal and other items |
Adjusted results |
|||||||||||||||||||||||||
| £m | £m | £m | £m | £m | £m | £m | £m | |||||||||||||||||||||||||
| Gross profit from continuing operations |
16,425 | 649 | 585 | 23 | — | 17,682 | ||||||||||||||||||||||||||
| Operating profit from continuing operations |
5,979 | 724 | 200 | 1,178 | 1,237 | (2,662 | ) | 6,656 | ||||||||||||||||||||||||
| Profit before taxation from continuing operations |
5,170 | 724 | 200 | 1,180 | 1,237 | (2,660 | ) | 5,851 | ||||||||||||||||||||||||
| Profit after taxation from continuing operations |
5,103 | 582 | 162 | 967 | 1,006 | (2,785 | ) | 5,035 | ||||||||||||||||||||||||
| Profit after taxation from discontinued operations |
1,285 | (1,285 | ) | — | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total profit after taxation |
6,388 | (1,285 | ) | 582 | 162 | 967 | 1,006 | (2,785 | ) | 5,035 | ||||||||||||||||||||||
| Profit attributable to shareholders from continuing operations |
4,873 | 582 | 162 | 967 | 755 | (2,785 | ) | 4,554 | ||||||||||||||||||||||||
| Profit attributable to shareholders from discontinued operations |
876 | (876 | ) | — | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total profit attributable to shareholders |
5,749 | (876 | ) | 582 | 162 | 967 | 755 | (2,785 | ) | 4,554 | ||||||||||||||||||||||
| Basic earnings per share (pence) from continuing operations |
122.4 | p | 14.6 | p | 4.1 | p | 24.3 | p | 19.0 | p | (70.0 | )p | 114.4 | p | ||||||||||||||||||
| Basic earnings per share (pence) from discontinued operations |
22.0 | p | (22.0 | )p | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total Basic earnings per share (pence) |
144.4 | p | (22.0 | )p | 14.6 | p | 4.1 | p | 24.3 | p | 19.0 | p | (70.0 | )p | 114.4 | p | ||||||||||||||||
| Weighted average number of shares (millions) |
3,981 | 3,981 | ||||||||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted gross profit from continuing operations |
| |||||||||||||||||||||||||||||||
| Cost of sales |
(7,929 | ) | 649 | 585 | 23 | — | (6,672 | ) | ||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted operating profit from continuing operations |
| |||||||||||||||||||||||||||||||
| Selling, general and administration |
(7,437 | ) | 2 | 395 | (1 | ) | 16 | (7,025 | ) | |||||||||||||||||||||||
| Research and development |
(4,793 | ) | 75 | 198 | 198 | (4,322 | ) | |||||||||||||||||||||||||
| Other operating (expense)/income |
1,784 | 1,215 | (2,678 | ) | 321 | |||||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted profit before tax from continuing operations |
| |||||||||||||||||||||||||||||||
| Net finance costs |
(842 | ) | 2 | 2 | (838 | ) | ||||||||||||||||||||||||||
| Share of after tax losses of associates and joint ventures |
33 | 33 | ||||||||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted profit after tax from continuing operations |
| |||||||||||||||||||||||||||||||
| Taxation |
(67 | ) | (142 | ) | (38 | ) | (213 | ) | (231 | ) | (125 | ) | (816 | ) | ||||||||||||||||||
| The following adjustments are made in arriving at Adjusted profit attributable to shareholders |
| |||||||||||||||||||||||||||||||
| Profit attributable to non-controlling interests from continuing operations |
230 | 251 | 481 | |||||||||||||||||||||||||||||
| Profit attributable to non-controlling interests from discontinued operations |
409 | (409 | ) | — | ||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total profit attributable to non-controlling interests |
639 | (409 | ) | — | — | — | 251 | — | 481 | |||||||||||||||||||||||
13
Table of Contents
Group financial review 2022
Summary full year results
| Full year 2022 £m |
Growth AER % |
Growth CER % |
Full year 2021(1) £m |
Full year 2020(1) £m |
||||||||||||||||
| Turnover |
29,324 | 19 | 13 | 24,696 | 24,354 | |||||||||||||||
| Total continuing operating profit(1) |
6,433 | 48 | 31 | 4,357 | 5,979 | |||||||||||||||
| Total EPS(1) |
371.4p | 100 | 100 | 109.6p | 144.4p | |||||||||||||||
| Total continuing EPS(1) |
110.8p | 34 | 18 | 82.9p | 122.4p | |||||||||||||||
| Total discontinued EPS(1) |
260.6p | 100 | 100 | 26.7p | 22.0p | |||||||||||||||
| Adjusted operating profit(1) |
8,151 | 26 | 14 | 6,493 | 6,656 | |||||||||||||||
| Adjusted EPS(1) |
139.7p | 27 | 15 | 110.3p | 114.4p | |||||||||||||||
| Cash generated from operations attributable to continuing operations(1) |
7,944 | 10 | 7,249 | 7,674 | ||||||||||||||||
| Free cash flow |
3,348 | 1 | 3,301 | 3,683 | ||||||||||||||||
|
|
|
|
|
|
|
|
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|
|
|||||||||||
| (1) | The amounts presented above for continuing operations and Adjusted results excludes the Consumer Healthcare business discontinued operation. The amounts presented for discontinued EPS are for the demerger of the Consumer Healthcare business. The presentation of continuing and discontinued operations under IFRS 5 are set out on page 192 of the GSK Annual Report 2022. The 2021 and 2020 comparative results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below) and the impact of the Share Consolidation implemented on 18 July 2022 (see “Note 37 – Share capital and share premium account” to the financial statements incorporated by reference in Item 18 below). |
| (2) | Adjusted results are non-IFRS measures excluding discontinued operations and other adjustments that may be considered in addition to, but not as a substitute for, or superior to, information presented in accordance with IFRS. Adjusted results, AER growth, CER growth, free cash flow and other non-IFRS measures are defined below under “Reporting framework”. Adjusted results reconciliations are presented above on pages 11 to 13 above and free cash flow reconciliations are presented below on page 29 below. |
Total Turnover
Total turnover in 2022 was £29,324 million, up 19% at AER, 13% at CER, reflecting strong performance in all three product groups. Sales of COVID-19 solutions contributed 3% growth at AER and CER to Commercial Operations turnover. Specialty Medicines included £2,309 million sales of Xevudy, and double-digit growth across all therapy areas. Vaccines growth reflected strong Shingrix and Meningitis performance, partially offset by pandemic adjuvant sales in 2021. General Medicines reflected the recovery of the antibiotics market and the strong performance of Trelegy in respiratory across all regions.
Specialty Medicines
Specialty Medicines sales were £11,269 million, up 37% at AER, 29% at CER, driven by consistent double-digit growth in all therapy areas. Sales of Xevudy of £2,309 million contributed growth of 14% at AER and CER. Specialty Medicines, were £8,960 million up 23% at AER, 15% at CER without Xevudy.
Vaccines
Vaccines turnover was £7,937 million, up 17% at AER, 11% at CER in total. Sales of pandemic adjuvant contributed 7% growth at AER and 6% CER to Commercial Operations turnover.
The performance reflected a favourable comparator, which was impacted by COVID-19 related disruptions in several markets primarily in H1 2021, and strong commercial execution of Shingrix, particularly in the US and Europe.
General Medicines
General Medicines sales in the year were £10,118 million, up 5% at AER, 1% at CER, with the impact of generic competition in US, Europe and Japan offset by Trelegy growth in respiratory and the post-pandemic rebound of the antibiotic market since H2 2021, in Other General Medicines.
Total Continuing Operating Profit
Total operating profit from continuing operations was £6,433 million compared with £4,357 million in 2021. This included the £0.9 billion upfront income received from the settlement with Gilead Sciences, Inc. (Gilead), increased profits on turnover growth of 13% at CER and fair value gains on investments, partly offset by higher remeasurement charges for contingent consideration liabilities.
Total continuing Adjusted operating profit
Adjusted operating profit was £8,151 million, 26% higher at AER and 14% at CER than 2021. The Adjusted operating margin of 27.8% was 1.5 percentage points higher at AER and 0.3 percentage points higher at CER compared to 2021. This primarily reflected the impact from low margin COVID-19 solutions sales (Xevudy). This was offset by operating leverage from strong sales growth, mix benefit, lower inventory adjustments and write-offs and higher royalty income.
14
Table of Contents
Total Earnings per Share
Total EPS was 371.4p compared with 109.6p in 2021. The increase primarily reflected the profit after taxation for discontinued operations recognised on the Consumer Healthcare business demerger, upfront income received from the settlement with Gilead, increased profits and fair value gains on investments, partly offset by higher remeasurement charges for contingent consideration liabilities and an unfavourable comparison due to a credit of £397 million to Taxation in 2021.
Total continuing Earnings per Share
Total EPS from continuing operations was 110.8p compared with 82.9p in 2021. This primarily reflected the upfront income received from the settlement with Gilead, increased profits from turnover growth and fair value gains on investments, partly offset by higher remeasurement charges for contingent consideration liabilities and an unfavourable comparison due to a credit of £430 million to Taxation in 2021.
Total discontinued Earnings per Share
EPS from discontinued operations was 260.6p, compared with 26.7p in 2021. The increase primarily reflected the gain arising on the demerger of Consumer Healthcare recognised in Profit after taxation for discontinued operations.
Adjusted Earnings per Share
Adjusted EPS was 139.7p compared with 110.3p in 2021. Operating leverage from strong sales growth, beneficial mix and lower inventory adjustments and write-offs, higher royalty income and a lower effective tax rate was partly offset by increased investment behind launches, higher supply chain, freight and distribution costs and higher non-controlling interests.
Cash generated from operations attributable to continuing operations
Cash generated from operations attributable to continuing operations for the year was £7,944 million (2021: £7,249 million). The increase primarily reflected a significant increase in operating profit, favourable exchange impact and favourable timing of collections, partly offset by unfavourable timing of profit share payments for Xevudy sales, increased cash contributions to the UK defined benefit pension schemes, increased contingent consideration payments and a higher increase in inventory.
Free cash flow
Free cash inflow from continuing operations was £3,348 million for 2022 (2021: £3,301 million). The increase primarily reflected a significant increase in operating profit, favourable exchange, reduced purchases of intangible assets and favourable timing of collections. This was partly offset by unfavourable timing of profit share payments for Xevudy sales, increased cash contributions to pensions, increased contingent consideration payments, higher tax payments, lower proceeds from disposals, higher capital expenditure and a higher increase in inventory.
15
Table of Contents
Financial performance
The Total results of the Group are set out below.
| 2022 | 2021(1) | Growth | ||||||||||||||||||||||
| % of | % of | |||||||||||||||||||||||
| £m | turnover | £m | turnover | £% | CER% | |||||||||||||||||||
| Turnover |
29,324 | 100 | 24,696 | 100 | 19 | 13 | ||||||||||||||||||
| Cost of sales |
(9,554 | ) | (32.6 | ) | (8,163 | ) | (33.1 | ) | 17 | 16 | ||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| Gross profit |
19,770 | 67.4 | 16,533 | 66.9 | 20 | 12 | ||||||||||||||||||
| Selling, general and administration |
(8,372 | ) | (28.6 | ) | (7,070 | ) | (28.6 | ) | 18 | 13 | ||||||||||||||
| Research and development |
(5,488 | ) | (18.7 | ) | (5,019 | ) | (20.3 | ) | 9 | 4 | ||||||||||||||
| Royalty income |
758 | 2.6 | 417 | 1.7 | 82 | 81 | ||||||||||||||||||
| Other operating (expenses)/income |
(235 | ) | (504 | ) | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| Operating profit |
6,433 | 21.9 | 4,357 | 17.6 | 48 | 31 | ||||||||||||||||||
| Net finance costs |
(803 | ) | (755 | ) | ||||||||||||||||||||
| Loss on disposal of interest in associates |
— | (36 | ) | |||||||||||||||||||||
| Share of after-tax (losses)/profits of associates and joint ventures |
(2 | ) | 33 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Profit before taxation |
5,628 | 3,599 | 56 | 37 | ||||||||||||||||||||
| Taxation |
(707 | ) | (83 | ) | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Profit after taxation from continuing operations for the year |
4,921 | 3,516 | 40 | 23 | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Profit after taxation from discontinued operations and other gains from the demerger |
3,049 | 1,580 | ||||||||||||||||||||||
| Remeasurement of discontinued operations distributed to shareholders on demerger |
7,651 | — | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Profit after taxation from discontinued operations |
10,700 | 1,580 | 100 | 100 | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total profit after taxation for the year |
15,621 | 5,096 | 100 | 100 | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Profit attributable to non-controlling interests from continuing operations |
460 | 200 | ||||||||||||||||||||||
| Profit attributable to shareholders from continuing operations |
4,461 | 3,316 | ||||||||||||||||||||||
| Profit attributable to non-controlling interests from discontinued operations |
205 | 511 | ||||||||||||||||||||||
| Profit attributable to shareholders from discontinued operations |
10,495 | 1,069 | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| 15,621 | 5,096 | 100 | 100 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total profit attributable to non-controlling interests |
665 | 711 | ||||||||||||||||||||||
| Total profit attributable to shareholders |
14,956 | 4,385 | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| 15,621 | 5,096 | 100 | 100 | |||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Earnings per share from continuing operations (p) |
110.8 | p | 82.9 | p | 34 | 18 | ||||||||||||||||||
| Earnings per share from discontinued operations (p) |
260.6 | p | 26.7 | p | 100 | 100 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Total earnings per share (p) |
371.4 | p | 109.6 | p | 100 | 100 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Earnings per ADS from continuing operations (US$) |
2.75 | 2.29 | ||||||||||||||||||||||
| Earnings per ADS from discontinued operations (US$) |
6.46 | 0.73 | ||||||||||||||||||||||
|
|
|
|
|
|||||||||||||||||||||
| Total earnings per ADS (US$) |
9.21 | 3.02 | ||||||||||||||||||||||
|
|
|
|
|
|||||||||||||||||||||
| (1) | The 2021 comparative results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
16
Table of Contents
The Adjusted results for the Group are set out below. Reconciliations between Total results and Adjusted results for 2022, 2021 and 2020 are set out above on pages 11 to 13.
| 2022 | 2021(1) | Growth | ||||||||||||||||||||||
| £m | % of turnover |
£m | % of turnover |
£% | CER% | |||||||||||||||||||
| Turnover |
29,324 | 100 | 24,696 | 100 | 19 | 13 | ||||||||||||||||||
| Cost of sales |
(8,741 | ) | (29.8 | ) | (7,346 | ) | (29.7 | ) | 19 | 18 | ||||||||||||||
| Selling, general and administration |
(8,128 | ) | (27.7 | ) | (6,749 | ) | (27.3 | ) | 20 | 15 | ||||||||||||||
| Research and development |
(5,062 | ) | (17.3 | ) | (4,525 | ) | (18.3 | ) | 12 | 6 | ||||||||||||||
| Royalty income |
758 | 2.6 | 417 | 1.6 | 82 | 81 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| Adjusted(2) operating profit |
8,151 | 27.8 | 6,493 | 26.3 | 26 | 14 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| Adjusted profit attributable to shareholders |
5,625 | 4,415 | 27 | 15 | ||||||||||||||||||||
| Adjusted profit attributable to non-controlling interest |
595 | 441 | ||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Adjusted profit after tax |
6,220 | 4,856 | 28 | 16 | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| Adjusted earnings per share (p) |
139.7 | p | 110.3 | p | 27 | 15 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||||||||||
| (1) | The 2021 comparative results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below) and the impact of the Share Consolidation implemented on 18 July 2022 (see “Note 37 – Share capital and share premium account” to the financial statements incorporated by reference in Item 18 below). |
| (2) | Adjusted results are non-IFRS measures excluding discontinued operations and other adjustments that may be considered in addition to, but not as a substitute for, or superior to, information presented in accordance with IFRS. Adjusted results, AER growth, CER growth and other non-IFRS measures are defined below under “Reporting framework”. |
Reporting framework
Total and Adjusted results
The Group financial review discusses the operating and financial performance of the Group, its cash flows and financial position and our resources. The results for each year are compared primarily with the results of the preceding year.
Total results
Total reported results represent the Group’s overall performance.
GSK also uses a number of adjusted, non-IFRS, measures to report the performance of its business. Adjusted results and other non-IFRS measures may be considered in addition to, but not as a substitute for or superior to, information presented in accordance with IFRS. Adjusted results are defined below and other non-IFRS measures are defined below.
GSK believes that Adjusted results, when considered together with Total results, provide investors, analysts and other stakeholders with helpful complementary information to understand better the financial performance and position of the Group from period to period, and allow the Group’s performance to be more easily compared against the majority of its peer companies. These measures are also used by management for planning and reporting purposes. They may not be directly comparable with similarly described measures used by other companies.
GSK encourages investors and analysts not to rely on any single financial measure but to review GSK’s Annual Reports, including the financial statements and notes, in their entirety.
Adjusted results
Adjusted results exclude the profits from discontinued operations from the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below) and the following items in relation to our continuing operations from Total results, together with the tax effects of all of these items:
| – | amortisation of intangible assets (excluding computer software and capitalised development costs) |
| – | impairment of intangible assets (excluding computer software) and goodwill |
| – | Major restructuring costs, which include impairments of tangible assets and computer software, (under specific Board approved programmes that are structural, of a significant scale and where the costs of individual or related projects exceed £25 million) including integration costs following material acquisitions |
| – | transaction-related accounting or other adjustments related to significant acquisitions |
| – | proceeds and costs of disposals of associates, products and businesses; significant settlement income; significant legal charges (net of insurance recoveries) and expenses on the settlement of litigation and government investigations; other operating income other than royalty income, and other items |
Costs for all other ordinary course smaller scale restructuring and legal charges and expenses are retained within both Total and Adjusted results.
As Adjusted results include the benefits of Major restructuring programmes but exclude significant costs (such as amortisation of intangible assets except for computer software and capitalised development costs, significant legal, major restructuring and transaction items), they should not be regarded as a complete picture of the Group’s financial performance, which is presented in its Total results. The exclusion of other Adjusting items may result in Adjusted earnings being materially higher or lower than Total earnings. In particular, when significant impairments, restructuring charges and legal costs are excluded, Adjusted earnings will be higher than Total earnings.
17
Table of Contents
GSK is undertaking a number of Major restructuring programmes in response to significant changes in the Group’s trading environment or overall strategy, or following material acquisitions. Costs, both cash and non-cash, of these programmes are provided for as individual elements are approved and meet the accounting recognition criteria. As a result, charges may be incurred over a number of years following the initiation of a Major restructuring programme.
Significant legal charges and expenses are those arising from the settlement of litigation or government investigations that are not in the normal course and are materially larger than more regularly occurring individual matters. They also include certain major legacy matters.
Reconciliations between Total and Adjusted results, providing further information on the key Adjusting items for 2022, 2021 and 2020, are set out on pages 11 to 13.
GSK provides earnings guidance to the investor community on the basis of Adjusted results. This is in line with peer companies and expectations of the investor community, supporting easier comparison of the Group’s performance with its peers. GSK is not able to give guidance for Total results as it cannot reliably forecast certain material elements of the Total results, particularly the future fair value movements on contingent consideration and put options that can and have given rise to significant adjustments driven by external factors such as currency and other movements in capital markets, and therefore a reconciliation of the guidance for Adjusted results to equivalent guidance for Total results is not available without unreasonable effort.
Historical record of Adjusting items
The reconciliations between Total and Adjusted operating profit from continuing operations over the last three years(1) can be summarised as follows:
| 2022 £m |
2021(2) £m |
2020(2) £m |
||||||||||
| Total operating profit from continuing operations |
6,433 | 4,357 | 5,979 | |||||||||
| Intangible amortisation |
739 | 761 | 724 | |||||||||
| Intangible impairment |
296 | 347 | 200 | |||||||||
| Major restructuring |
321 | 424 | 1,178 | |||||||||
| Transaction-related items |
1,750 | 1,143 | 1,237 | |||||||||
| Divestments, significant legal and other items |
(1,388 | ) | (539 | ) | (2,662 | ) | ||||||
|
|
|
|
|
|
|
|||||||
| Adjusted results |
8,151 | 6,493 | 6,656 | |||||||||
|
|
|
|
|
|
|
|||||||
The analysis of the impact of transaction-related items on operating profit for each of the last three years is as follows:
| 2022 £m |
2021(2) £m |
2020(2) £m |
||||||||||
| Contingent consideration on former Shionogi-ViiV Healthcare JV (including Shionogi preferential dividends) |
1,431 | 1,026 | 1,114 | |||||||||
| ViiV Healthcare put options and Pfizer preferential dividends |
85 | 48 | (52 | ) | ||||||||
| Contingent consideration on former Novartis Vaccines business |
193 | 27 | 172 | |||||||||
| Contingent consideration on acquisition of Affinivax, Inc (Affinivax) |
17 | – | – | |||||||||
| Other adjustments |
24 | 42 | 3 | |||||||||
|
|
|
|
|
|
|
|||||||
| Transaction-related items |
1,750 | 1,143 | 1,237 | |||||||||
|
|
|
|
|
|
|
|||||||
| (1) | Three year financial data is presented reflecting the restated results following the demerger of Consumer Healthcare business. The financial results of 2019 and 2018 are not restated and are not presented. |
| (2) | The 2021 and 2020 comparative results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
Full reconciliations between Total and Adjusted results for 2020–2022 including continuing and discontinued operations are set out above on pages 11 to 13 above. Further explanations on the Adjusting items for 2022 are reported on pages 27 to 29 below.
Other non-IFRS measures
Free cash flow
Free cash flow is defined as the net cash inflow/outflow from continuing operating activities less capital expenditure on property, plant and equipment and intangible assets, contingent consideration payments, net finance costs, and dividends paid to non-controlling interests plus proceeds from the sale of property, plant and equipment and intangible assets, and dividends received from joint ventures and associates. It is used by management for planning and reporting purposes and in discussions with and presentations to investment analysts and rating agencies. Free cash flow growth is calculated on a reported basis. A reconciliation of net cash inflow from continuing operating activities to free cash flow is set out on page 29 below.
18
Table of Contents
Working capital
Working capital represents inventory and trade receivables less trade payables.
CER and AER growth
In order to illustrate underlying performance, it is the Group’s practice to discuss its results in terms of constant exchange rate (CER) growth. This represents growth calculated as if the exchange rates used to determine the results of overseas companies in Sterling had remained unchanged from those used in the comparative period. CER% represents growth at constant exchange rates. £% or AER% represents growth at actual exchange rates.
Total net debt
Net debt is defined as total borrowings less cash, cash equivalents, liquid investments, and short-term loans to third parties that are subject to an insignificant risk of change in value. Please see “Note 30 – Net Debt” to the financial statements incorporated by reference in Item 18 below for the calculation of net debt.
Non-controlling interests in ViiV Healthcare
Trading profit allocations
As ViiV Healthcare is a subsidiary of the Group, 100% of its operating results (turnover, operating profit, profit after tax) are included within the Group income statement and then a portion of the earnings is allocated to the non-controlling interests owned by the other shareholders, in line with their respective equity shareholdings (Pfizer, Inc. (Pfizer) 11.7% and Shionogi Co. Ltd (Shionogi) 10%). Each of the shareholders, including GSK, is also entitled to preferential dividends determined by the performance of certain products that each shareholder contributed. As the relative performance of these products changes over time, the proportion of the overall earnings allocated to each shareholder also changes. In particular, the increasing proportion of sales of dolutegravir and cabotegravir-containing products has a favourable impact on the proportion of the preferential dividends that is allocated to GSK. Adjusting items are allocated to shareholders based on their equity interests. GSK was entitled to approximately 83% of the Total earnings and 82% of the Adjusted earnings of ViiV Healthcare for 2022. Remeasurements of the liabilities for the preferential dividends allocated to Pfizer and Shionogi are included within other operating income/(expense).
Acquisition-related arrangements
As consideration for the acquisition of Shionogi’s interest in the former Shionogi-ViiV Healthcare joint venture in 2012, Shionogi received the 10% equity stake in ViiV Healthcare and ViiV Healthcare also agreed to pay additional future cash consideration to Shionogi, contingent on the future sales performance of the products being developed by that joint venture, dolutegravir and cabotegravir. Under IFRS 3 `Business combinations’, GSK was required to provide for the estimated fair value of this contingent consideration at the time of acquisition and is required to update the liability to the latest estimate of fair value at each subsequent period end. The liability for the contingent consideration recognised in the balance sheet at the date of acquisition was £659 million. Subsequent re-measurements are reflected within other operating income/(expense) and within Adjusting items in the income statement in each period.
Cash payments to settle the contingent consideration are made to Shionogi by ViiV Healthcare each quarter, based on the actual sales performance and other income of the relevant products in the previous quarter. These payments reduce the balance sheet liability and hence are not recorded in the income statement. The cash payments made to Shionogi by ViiV Healthcare in 2022 were £1,100 million.
As the liability is required to be recorded at the fair value of estimated future payments, there is a significant timing difference between the charges that are recorded in the Total income statement to reflect movements in the fair value of the liability and the actual cash payments made to settle the liability.
The cash payments are reflected in the cash flow statement partly in operating cash flows and partly within investing activities. The tax relief on these payments is reflected in the Group’s Adjusting items as part of the tax charge. The part of each payment relating to the original estimate of the fair value of the contingent consideration on the acquisition of the Shionogi-ViiV Healthcare joint venture in 2012 of £659 million is reported within investing activities in the cash flow statement and the part of each payment relating to the increase in the liability since the acquisition is reported within operating cash flows.
Movements in contingent consideration payable to Shionogi were as follows:
| 2022 £m |
2021 £m |
|||||||
| Contingent consideration at beginning of the year |
5,559 | 5,359 | ||||||
| Remeasurement through income statement and other movements |
1,431 | 1,026 | ||||||
| Cash payments: operating cash flows |
(1,031 | ) | (721 | ) | ||||
| Cash payments: investing activities |
(69 | ) | (105 | ) | ||||
|
|
|
|
|
|||||
| Contingent consideration at end of the year |
5,890 | 5,559 | ||||||
|
|
|
|
|
|||||
Of the contingent consideration payable (on a post-tax basis) to Shionogi at 31 December 2022, £940 million (31 December 2021: £937 million) is expected to be paid within one year.
19
Table of Contents
Exit rights
Pfizer may request an IPO of ViiV Healthcare at any time and if either GSK does not consent to such IPO or an offering is not completed within nine months, Pfizer could require GSK to acquire its shareholding. Under the original agreements, GSK had the unconditional right, so long as it made no subsequent distribution to its shareholders, to withhold its consent to the exercise of the Pfizer put option and, as a result, in accordance with IFRS, GSK did not recognise a liability for the put option on its balance sheet. However, during Q1 2016, GSK notified Pfizer that it had irrevocably given up this right and accordingly recognised the liability for the put option on the Group’s balance sheet during Q1 2016 at an initial value of £1,070 million. Consistent with this revised treatment, at the end of Q1 2016 GSK also recognised liabilities for the future preferential dividends anticipated to become payable to Pfizer and Shionogi on the Group’s balance sheet.
Pfizer has the right to require GSK to acquire its shareholding in ViiV Healthcare in certain circumstances at any time. A put option liability is therefore recorded on the Group’s balance sheet as a current liability. It is measured on the gross redemption basis derived from an internal valuation of the ViiV Healthcare business.
The closing balances of the liabilities related to Pfizer’s shareholding are as follows:
| 2022 £m |
2021 £m |
|||||||
| Pfizer put option |
1,093 | 1,008 | ||||||
|
|
|
|
|
|||||
Under the original agreements, Shionogi could also have requested GSK to acquire its shareholding in ViiV Healthcare in six-month windows commencing in 2017, 2020 and 2022. GSK had the unconditional right, so long as it made no subsequent distribution to its shareholders, to withhold its consent to the exercise of the Shionogi put option and, as a result, GSK did not recognise a liability for the put option on its balance sheet.
However, during Q1 2016, GSK notified Shionogi that it had irrevocably given up this right and accordingly recognised the liability for the put option on the Group’s balance sheet during Q1 2016 at an initial value of £926 million. In Q4 2016, Shionogi irrevocably agreed to waive its put option and as a result GSK de-recognised the liability for this put option on the Group’s balance sheet directly to equity. The value of the liability was £1,244 million when it was de-recognised.
GSK also has a call option over Shionogi’s shareholding in ViiV Healthcare, which under the original agreements was exercisable in six-month windows commencing in 2027, 2030 and 2032. GSK has now irrevocably agreed to waive the first two exercise windows, but the last six-month window in 2032 remains. As this call option is at fair value, it has no value for accounting purposes.
Settlement with Gilead
On 1 February 2022, ViiV Healthcare reached agreement with Gilead to settle the global patent infringement litigation relating to the commercialisation of Gilead’s Biktarvy. Under the terms of the global settlement and licensing agreement, Gilead made an upfront payment of $1.25 billion to ViiV Healthcare in February 2022. In addition, Gilead will also pay a 3% royalty on all future US sales of Biktarvy and in respect of the bictegravir component of any other future bictegravir- containing products sold in the US. These royalties will be payable by Gilead to ViiV Healthcare from 1 February 2022 until the expiry of ViiV Healthcare’s US Patent No. 8,129,385 on 5 October 2027. Gilead’s obligation to pay royalties does not extend into any period of regulatory paediatric exclusivity, if awarded.
The impact of the settlement with Gilead on the contingent consideration liability (CCL) was to increase it by £288 million, on a post-tax basis in Q4 2021 due to the obligation ViiV Healthcare has to pay future cash consideration to Shionogi for its share of the upfront and of the future US sales performance of Biktarvy and products containing bictegravir. The liability which is discounted at 8% is £5,890 million at 31 December 2022 on a post-tax basis. The impact of the settlement on the Pfizer put option liability was an increase of £114 million and was included in the re-measurement at 31 December 2021.
Reporting definitions
COVID-19 solutions
COVID-19 solutions include the sales of pandemic adjuvant and other COVID-19 solutions including vaccine manufacturing and Xevudy and the associated costs but does not include reinvestment in RD. This categorisation is used by management and we believe is helpful to investors by providing clarity on the results of the Group by showing the contribution to growth from COVID-19 solutions.
General Medicines
General medicines are usually prescribed in the primary care or community settings by general healthcare practitioners. For GSK, this includes medicines in inhaled respiratory, dermatology, antibiotics and other diseases.
Specialty Medicines
Specialty medicines are typically prescription medicines used to treat complex or rare chronic conditions. For GSK, this comprises medicines in infectious diseases, HIV, oncology, immunology and respiratory.
Total Operating Margin
Total Operating margin is operating profit dividend by turnover.
Compound Annual Growth Rate (CAGR)
CAGR is defined as the compound annual growth rate and shows the annualised average rate of revenue growth between a number of given years, assuming growth takes place at an exponentially compounded rate.
20
Table of Contents
Share Consolidation
Shareholders received 4 new Ordinary shares with a nominal value of 311⁄4 pence each for every 5 existing Ordinary shares which had a nominal value of 25 pence each. Earnings per share, diluted earnings per share, adjusted earnings per share and dividends per share were retrospectively adjusted to reflect the Share Consolidation in all the periods presented.
Earnings per share
Earnings per share has been retrospectively adjusted for the Share Consolidation on 18 July 2022, applying a ratio of 4 new Ordinary shares for every 5 existing Ordinary shares.
Total Earnings per share
Unless otherwise stated, Total earnings per share refers to Total basic earnings per share. The same principle applies to continuing and discontinued earnings per share.
Financial performance
Group turnover
GSK has revised its operating segments during the year. Previously, GSK reported results under four segments: Pharmaceuticals; Pharmaceuticals RD; Vaccines and Consumer Healthcare. GSK now reports results under two segments namely Commercial Operations and Total RD. See “Note 6 – Turnover and segment information” to the financial statements incorporated by reference in Item 18 below for more details.
The Commercial Operations segment has three product groups of Specialty Medicines, Vaccines and General Medicines.
| – | Specialty Medicines products which includes GSK’s marketed products for HIV, oncology, immuno-inflammation, respiratory and other specialty medicines (including Nucala) and the COVID-19 solution, Xevudy; |
| – | Vaccines products, including sales of GSK’s AS03 adjuvant as part of the pandemic solutions; |
| – | General Medicines products, which include products previously reported as Established Pharmaceuticals and sales of Trelegy Ellipta and Anoro Ellipta (previously reported within the Respiratory category under Specialty products). These products are typically accessed by patients through primary care settings. |
Group turnover was £29,324 million in the year, up 19% at AER, 13% at CER. In 2022 sales of COVID-19 solutions contributed 3% growth at AER and CER.
Commercial operations Innovation sales (sales of products launched in the last five years including lifecycle innovation) amounted to £12,690 million in 2022 largely driven by sales of Shingrix, Xevudy, Trelegy, Dovato, Nucala and Benlysta.
Specialty medicines turnover
| 2022 £m |
2021 (revised) £m |
Growth £% |
Growth CER% |
|||||||||||||
| HIV |
5,749 | 4,777 | 20 | 12 | ||||||||||||
| Oncology |
602 | 489 | 23 | 17 | ||||||||||||
| Immuno-inflammation, respiratory and other |
2,609 | 2,027 | 29 | 20 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| 8,960 | 7,293 | 23 | 15 | |||||||||||||
| Pandemic |
2,309 | 958 | 100 | 100 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Specialty medicines |
11,269 | 8,251 | 37 | 29 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
2021 has been revised to reflect changes to product groups previously reported as Established Pharmaceuticals.
HIV
HIV sales were £5,749 million with growth of 20% at AER, 12% at CER. The performance benefited from strong patient demand for the new HIV medicines (Dovato, Cabenuva, Juluca, Rukobia and Apretude), which contributed approximately three quarters of the growth. US pricing favourability and year-end inventory build together contributed one third of the growth which was partially offset by International tender decline.
New HIV products delivered sales of over two billion to £2,474 million, up 78% at AER, 67% at CER, representing 43% of the total HIV portfolio compared to 29% last year. Growth was primarily driven by sales of Dovato and Cabenuva. Dovato recorded sales of £1,375 million up 75% at AER and 65% at CER and Cabenuva, the first long acting injectable for the treatment of HIV-1 infection, recorded sales of £340 million. Apretude, the first long acting injectable for the prevention of HIV-1 delivered sales of £41 million.
Oncology
Oncology sales were £602 million, up 23% at AER, 17% at CER. Zejula sales of £463 million were up 17% at AER, 12% at CER driven by the first line indication, but with diagnosis and treatment rates continuing to be impacted by the pandemic especially in the US. Sales of Blenrep of £118 million grew 33% at AER, 25% at CER, and included the impact of withdrawal from US market in Q4 2022.
21
Table of Contents
Immuno-inflammation, respiratory and other
Immuno-inflammation, Respiratory and Other sales were £2,609 million up 29% at AER, 20% at CER on strong performance of Benlysta and Nucala. Benlysta sales were £1,146 million, up 31% at AER, 20% at CER, representing strong underlying demand in US and worldwide. Nucala sales were £1,423 million, up 25% at AER, 18% at CER, reflecting continued strong patient demand and the launch of additional indications.
Pandemic
Sales of Xevudy were £2,309 million, compared to £958 million sales in 2021. Sales were delivered in all regions, comprising £828 million in the US, £456 million in Europe, and £1,025 million in International.
Vaccines turnover
| 2022 £m |
2021 £m |
Growth £% |
Growth CER% |
|||||||||||||
| Meningitis |
1,116 | 961 | 16 | 11 | ||||||||||||
| Influenza |
714 | 679 | 5 | (4 | ) | |||||||||||
| Shingles |
2,958 | 1,721 | 72 | 60 | ||||||||||||
| Established Vaccines |
3,085 | 2,970 | 4 | — | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Pandemic Vaccines |
7,873 | 6,331 | 24 | 17 | ||||||||||||
| 64 | 447 | (86 | ) | (86 | ) | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Vaccines |
7,937 | 6,778 | 17 | 11 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
Meningitis
Meningitis vaccines sales grew 16% at AER, 11% at CER to £1,116 million mainly driven by Bexsero up 16% at AER, 12% at CER to £753 million resulting from higher CDC (Center for Disease Control) demand and increased share in the US. Menveo sales were also up 27% AER, 18% CER to £345 million, primarily driven by post-pandemic vaccination catch-up and higher public demand in International, together with favourable pricing mix and share gain in the US.
Influenza
Fluarix/FluLaval sales grew by 5% AER but decreased 4% CER to £714 million, primarily driven by lower post-pandemic demand in Europe and the US, partly offset by lower expected returns in the US
Shingles
Shingrix sales grew 72% at AER, 60% at CER to £2,958 million. All regions grew significantly reflecting post-pandemic rebound, strong uptake and new market launches with more than half of the growth contributed from outside of the US. In the US, Shingrix grew 46% at AER, 32% at CER to £1,964 million due to higher non-retail and retail demand and strong commercial execution. Germany and China contributed strongly to the Shingrix growth. Shingrix was launched in 9 markets during 2022 and is now available in 26 countries.
Established Vaccines
Established Vaccines grew 4% AER but were stable at CER to £3,085 million mainly resulting from supply constraints in MMR/V vaccines and lower tender demand in International for Synflorix. This was offset by hepatitis vaccines demand rebound in the US and Europe and Boostrix post-pandemic demand recovery and increased share in the US.
Pandemic Vaccines
Pandemic Vaccines decreased 86% AER and CER primarily reflecting comparison to 2021 pandemic adjuvant sales to the US and Canadian governments partly offset by GSK’s share of 2022 contracted European volumes related to the COVID-19 booster vaccine developed through a collaboration with Sanofi Pasteur (Sanofi).
General Medicines turnover
| 2022 £m |
2021 (revised) £m |
Growth £% |
Growth CER% |
|||||||||||||
| Respiratory |
6,548 | 6,048 | 8 | 3 | ||||||||||||
| Other general medicines |
3,570 | 3,619 | (1 | ) | (2 | ) | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| General medicines |
10,118 | 9,667 | 5 | 1 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
2021 has been revised to reflect changes to product groups previously reported as Established Pharmaceuticals.
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Respiratory
Respiratory sales were £6,548 million, up 8% at AER, 3% at CER. The performance was driven by Trelegy sales of £1,729 million, up 42% AER, 32% CER, including strong growth across all regions. Advair/Seretide sales of £1,159 million decreased 15% at AER, 17% at CER predominantly reflecting the adverse impact of generic competition, with growth in certain International markets due to targeted promotion offsetting the decrease.
Other general medicines
Other General Medicines sales were £3,570 million, decreasing 1% at AER, 2% at CER. Augmentin sales were £576 million, up 35% at AER, 38% at CER, reflecting the post pandemic rebound of the antibiotic market since H2 2021 in the International and Europe regions. This partially offsets the ongoing adverse impact of generic competition, and approximately two percentage points impact at AER and CER from the divestment of cephalosporin products in Q4 2021.
Turnover by regions
US
In the US, sales were £14,542 million, up 22% at AER, 10% at CER. Sales of COVID-19 solutions contributed 2% growth at AER and CER to US Commercial Operations turnover.
Sales of Xevudy were £828 million.
In Specialty Medicines, HIV sales of £3,756 million were up 30% at AER, 17% at CER. Growth benefited from strong patient demand for all new HIV products, pricing favourability and year-end inventory build. New HIV medicines (Dovato, Cabenuva, Juluca, Rukobia and Apretude) sales were £1,685 million up 88% at AER, 70% at CER. Nucala in respiratory and Benlysta in immunology both continued to grow double-digit and reflected ongoing strong patient demand. Oncology sales increased 14% at AER, 3% at CER with diagnosis and treatment rates continuing to be impacted by the pandemic for Zejula, and the withdrawal of Blenrep from the US market in Q4 2022.
Vaccine sales were £4,243 million, up 22% at AER, 10% at CER. Sales of pandemic adjuvant contributed 9% growth at AER and 8% CER to US Commercial Operations turnover. The performance was primarily driven by Shingrix sales of £1,964 million up 46% at AER, 32% at CER, mostly due to higher non-retail and retail demand and strong commercial execution. Demand recovery in Established Vaccines and share gains in Meningitis vaccines also contributed to growth.
General Medicines sales were £3,572 million up 10% at AER down 1% at CER. Trelegy was up 47% at AER, 32% at CER reflecting increased patient demand and growth of the single inhaler triple therapy market, and Flovent grew on launch of authorised generics in the year. Overall, there was a three- percentage point reduction in growth of US General Medicines due to prior period Returns and Rebates (RAR) adjustments in the year.
Europe
In Europe, sales were £6,348 million, up 18% at AER, 19% at CER. Sales of COVID-19 solutions of £513 million contributed 8 percentage points of growth at AER and CER.
In Specialty Medicines, HIV sales were £1,310 million up 10% at AER, 10% at CER primarily driven by strong patient demand for Dovato, Cabenuva and Juluca. Dovato delivered sales of £478 million, Juluca £127 million and Cabenuva £40 million. Benlysta in immunology, Nucala in respiratory, and Oncology medicines Zejula, Blenrep and Jemperli all continued to show strong double-digit growth.
Vaccine sales were £1,884 million, up 31% at AER, 32% at CER. The performance was driven by Shingrix sales of £688 million, 100% at AER and CER, particularly in Germany. Pandemic adjuvant sales of £57 million contributed four percentage points of growth at AER and CER.
General Medicines sales of £2,079 million decreased 3% at AER and CER, reflecting the ongoing impact of generic competitive pressures on Seretide and the divestment in Q4 2021 of cephalosporin products which caused one percentage point of drag on growth at AER and CER. This was partly offset, however, by strong demand for Trelegy and the growth of Augmentin following the post-pandemic rebound of the antibiotic market since H2 2021.
International
International sales were £8,434 million, up 14% at AER and CER, including Xevudy sales of £1,025 million. Sales of COVID-19 solutions contributed 7% AER and 8% CER growth to International Commercial Operations turnover.
In Specialty Medicines, HIV sales were £683 million, stable at AER and decreased 3% at CER, primarily driven by tender decline. Excluding tenders, International grew driven by strong Dovato growth. Combined Tivicay and Triumeq sales were £506 million, down 12% at AER and 15% at CER. Nucala sales of £242 million grew 24% at AER and 28% at CER reflecting strong market growth and patient uptake. Benlysta sales of £114 million grew 44% at AER, 43% at CER reflecting growth in the biological market in Japan and inclusion on China’s National Reimbursement Drug List.
Vaccine sales were £1,810 million, down 3% at AER, 5% at CER, reflecting an 11 percentage points drag at AER and CER from COVID-19 vaccine adjuvant sales in 2021. Growth excluding COVID-19 solutions was driven by strong Shingrix take-up in China, Canada and Japan more than offsetting the impact of supply constraints in MMR/V vaccines and lower Synflorix tender demand across several markets.
23
Table of Contents
General Medicines sales were £4,467 million up 5% at AER and CER. Respiratory sales of £1,955 million increased 10% at AER, 9% at CER, with Trelegy sales up 47% at AER, 48% at CER reflecting strong demand and inclusion on China’s National Reimbursement Drug List. Sales of Advair/Seretide were up 3% at AER, 1% at CER with the adverse impact of generic competition offset by growth in certain markets due to targeted promotion. Other General Medicines sales of £2,512 million increased 1% at AER, 2% at CER, and reflected growth of Augmentin following the post-pandemic rebound of the antibiotic market since H2 2021, partially offset by generic competition and price reductions in certain markets.
Cost of sales
| 2022 £m |
2021(1) £m |
Growth £% |
Growth CER% |
|||||||||||||
| Total cost of sales |
(9,554 | ) | (8,163 | ) | 17 | 16 | ||||||||||
| Adjusted cost of sales |
(8,741 | ) | (7,346 | ) | 19 | 18 | ||||||||||
| (1) | The 2021 comparative results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
Total cost of sales as a percentage of turnover was 32.6%, 0.5 percentage points lower at AER and 0.9 percentage points higher in CER terms than 2021.
Adjusted cost of sales as a percentage of turnover was 29.8%, 0.1 percentage points higher at AER and 1.3 percentage points higher at CER compared with 2021. This primarily reflected higher sales of lower margin Xevudy compared to 2021 which included higher margin pandemic adjuvant sales, increasing cost of sales margin by 2.5 percentage points at AER and CER, as well as the impact of increased commodity prices and freight costs. This was partially offset by a favourable mix primarily from increased sales of Shingrix in the US and Europe and increased sales of HIV medicines in the US, lower inventory adjustments and write offs in Vaccines and continued contribution from restructuring savings.
Selling, general and administration
| 2022 £m |
2021(1) £m |
Growth £% |
Growth CER% |
|||||||||||||
| Total selling, general and administration |
(8,372 | ) | (7,070 | ) | 18 | 13 | ||||||||||
| Adjusted selling, general and administration |
(8,128 | ) | (6,749 | ) | 20 | 15 | ||||||||||
| (1) | The 2021 comparative results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
Total SGA costs as a percentage of turnover were 28.6%, 0.1 percentage points lower at AER and stable at CER compared to 2021. This included a reduction in restructuring charges.
Adjusted SGA costs as a percentage of turnover were 27.7%, 0.4 percentage points higher at AER and 0.5 percentage points higher at CER than in 2021. Adjusted SGA costs increased 20% at AER, 15% at CER which primarily reflected an increased level of launch investment in Specialty Medicines particularly HIV and Vaccines including Shingrix to drive post-pandemic recovery demand and support market expansion. The growth in Adjusted SGA also reflected an unfavourable comparison to a beneficial legal settlement in 2021 as well as impairment provisions relating to Russia and Ukraine. This growth was partly offset by the continuing benefit of restructuring and tight control of ongoing costs.
Research and development
| 2022 £m |
2021(1) £m |
Growth £% |
Growth CER% |
|||||||||||||
| Total research and development |
(5,488 | ) | (5,019 | ) | 9 | 4 | ||||||||||
| Adjusted research and development |
(5,062 | ) | (4,525 | ) | 12 | 6 | ||||||||||
| (1) | The 2021 comparative results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
Total RD expenditure was £5,488 million up 9% at AER, 4% at CER. This included amortisation and impairments.
Adjusted RD expenditure in the full-year increased by 12% at AER, and 6% at CER, to £5,062 million. This reflected continued increased investment across Vaccines clinical development, including investments into our mRNA technology platforms, continued investment in the late-stage portfolio and several early discovery programmes, as well as expenditure related to our recent acquisition of Affinivax, Inc (Affinivax).
In addition, in Specialty Medicines, the level of RD investment increased to support the phase III respiratory programme for depemokimab, a potential new medicine to treat severe asthma, and bepirovirsen, our study in chronic hepatitis B, in preparation for the start of the phase III trial. In Oncology, investment increased in our early-stage immuno-oncology assets and in momelotinib (MMB), our potential new treatment of myelofibrosis patients with anaemia, acquired as part of the recent Sierra Oncology acquisition. These increases in investment were offset by decreases related to the completion of several late-stage clinical development programmes and reduced RD investment in COVID-19 pandemic solutions versus 2021.
Royalty income
Royalty income was £758 million (2021: £417 million), up 82% at AER, 81% at CER, the increase primarily reflecting royalty income from Gilead under the settlement and licensing agreement with Gilead announced on 1 February 2022 and Gardasil royalty income increasing to £446 million due to higher sales.
24
Table of Contents
Other operating income/(expense)
Net other operating expense was £235 million (2021: £504 million) reflecting accounting charges of £1,726 million (2021: £1,101 million) arising from the remeasurement of contingent consideration liabilities and the liabilities for the Pfizer put option and Pfizer and Shionogi preferential dividends in ViiV Healthcare. This included a remeasurement charge of £1,431 million (2021: £1,026 million) for the contingent consideration liability due to Shionogi, including the unwinding of the discount of £410 million and a charge for £1,021 million primarily from changes to exchange rates as well as adjustments to sales forecasts. This was partly offset by £922 million upfront income received from the settlement with Gilead, fair value gain on investments including £229 million on the retained stake in Haleon plc (Haleon), reflecting an increase in share price since listing and milestone income from disposals.
Operating profit
Total operating profit from continuing operations was £6,433 million compared with £4,357 million in 2021. Total operating margin was 21.9%, lower compared to 2021 due to the net impact of adjusting items described on page 11.
This included the £922 million upfront income received from the settlement with Gilead, increased profits on turnover growth of 19% at AER, 13% at CER and fair value gains on investments including £229 million on the retained stake in Haleon, partly offset by higher remeasurement charges for contingent consideration liabilities. Adjusted operating profit was £8,151 million, 26% higher at AER and 14% at CER than 2021 on a turnover increase of 13% at CER. The Adjusted operating margin of 27.8% was 1.5 percentage points higher at AER and 0.3 percentage points higher at CER compared to 2021. This primarily reflected the impact from low margin COVID-19 solutions sales (Xevudy), which reduced Adjusted Operating profit growth by 3% AER and CER and reduced the Adjusted operating margin by approximately 1.4 percentage points at AER and approximately 1.3 percentage points at CER. This was offset by operating leverage from strong sales growth, mix benefit, lower inventory adjustments and write offs and higher royalty income.
Contingent consideration cash payments made to Shionogi and other companies reduce the balance sheet liability and hence are not recorded in the income statement. Total contingent consideration cash payments in 2022 amounted to £1,137 million (2021: £856 million). These included cash payments made to Shionogi of £1,100 million (2021: £826 million).
Adjusted operating profit by business
Commercial Operations operating profit was £13,590 million, up 19% at AER and 10% at CER on a turnover increase of 13% at CER. The operating margin of 46.3% was 0.1 percentage points lower at AER, 1.2 percentage points lower at CER than in 2021. This primarily reflected strong sales of lower margin Xevudy, increased investment behind launches in Specialty Medicines including HIV and Vaccines plus higher commodity, freight and distribution costs as well as an adverse comparison to a favourable legal settlement in 2021. This was partly offset by leverage from strong sales growth, mix and lower inventory adjustments and write-offs, continued tight control of ongoing costs, benefits from continued restructuring and increased royalty income from Biktarvy and Gardasil sales.
RD segment operating expenses were £5,060 million, up 11% at AER, 5% at CER, primarily reflecting increased investment in Vaccines including priority investments for mRNA, late stage portfolio and expenditure from the acquisition of Affinivax and in Specialty Medicines in early stage HIV and depemokimab. This was partly offset by decreases related to the completion of several late-stage clinical development programmes and reduced RD investment in COVID-19 pandemic solutions versus 2021.
Net finance costs
| Finance income |
2022 £m |
2021(1) £m |
||||||
| Interest and other income |
62 | 13 | ||||||
| Fair value movements |
14 | 1 | ||||||
|
|
|
|
|
|||||
| 76 | 14 | |||||||
|
|
|
|
|
|||||
| Finance expense |
||||||||
| Interest expense |
(789 | ) | (735 | ) | ||||
| Unwinding of discounts on provisions |
(7 | ) | (2 | ) | ||||
| Remeasurements and fair value movements |
(20 | ) | (2 | ) | ||||
| Finance expense on lease liabilities |
(30 | ) | (27 | ) | ||||
| Other finance expense |
(33 | ) | (3 | ) | ||||
|
|
|
|
|
|||||
| (879 | ) | (769 | ) | |||||
|
|
|
|
|
|||||
| (1) | The 2021 comparative results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
Total net finance costs were £803 million compared with £755 million in 2021. Adjusted net finance costs were £791 million compared with £752 million in 2021. The increase is mainly driven by costs associated with the Sterling Notes repurchase in Q4 2022 and higher interest on tax offset by increased interest income due to higher interest rates and larger cash balances as a result of the Consumer Healthcare demerger.
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Table of Contents
Share of after tax profits of associates and joint ventures
The share of after tax loss of associates and joint ventures was £2 million (2021: £33 million share of profit).
Loss on disposal of interest in associates
In 2021, the Group also reported a net loss on disposal of interests in associates of £36 million, primarily driven by a loss on disposal of our interest in the associate Innoviva Inc.
Profit before tax
Taking account of net finance costs, the share of profits of associates and loss on disposal of interest in associates, profit before taxation was £5,628 million compared with £3,599 million in 2021.
Taxation
| 2022 £m |
2021(1) £m |
|||||||
| UK current year charge |
200 | 119 | ||||||
| Rest of world current year charge |
1,351 | 593 | ||||||
| Charge/(credit) in respect of prior periods |
(60 | ) | 219 | |||||
|
|
|
|
|
|||||
| Total current taxation |
1,491 | 931 | ||||||
| Total deferred taxation |
(784 | ) | (848 | ) | ||||
|
|
|
|
|
|||||
| Taxation on total profits |
707 | 83 | ||||||
|
|
|
|
|
|||||
| (1) | The 2021 comparative results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
The charge of £707 million represented an effective tax rate on Total results of 12.6% (2021: 2.3%) and reflected the different tax effects of the various Adjusting items. Included in 2021 was a credit of £430 million resulting from the remeasurement of deferred tax assets following enactment of the proposed change of UK corporate income tax rates from 19% to 25%. Tax on Adjusted profit amounted to £1,138 million and represented an effective Adjusted tax rate of 15.5% (2021: 15.9%).
Issues related to taxation are described in Note 14 to the financial statements ‘Taxation’. The Group continues to believe it has made adequate provision for the liabilities likely to arise from periods which are open and not yet agreed by tax authorities. The ultimate liability for such matters may vary from the amounts provided and is dependent upon the outcome of agreements with relevant tax authorities.
Non-controlling interests
The allocation of Total profit from continuing operations to non-controlling interests amounted to £460 million (2021: £200 million). The increase was primarily due to an increased allocation of ViiV Healthcare profits of £416 million (2021: £197 million), including the Gilead upfront settlement income, partly offset by increased credits for remeasurement of contingent consideration liabilities, as well as higher net profits in some of the Group’s other entities with non-controlling interests.
The allocation of Adjusted earnings from continuing operations to non-controlling interests amounted to £595 million (2021: £441 million). The increase in allocation primarily reflected an increased allocation of ViiV Healthcare profits of £551 million (2021: £438 million), as well as higher net profits in some of the Group’s other entities with non-controlling interests.
Earnings per share from continuing operations
Total EPS from continuing operations was 110.8p compared with 82.9p in 2021. This primarily reflected the £922 million upfront income received from the settlement with Gilead, increased profits on turnover growth of 13% at CER and fair value gains on investments including the retained stake in Haleon, partly offset by higher remeasurement charges for contingent consideration liabilities and an unfavourable comparison due to a credit of £430 million to Taxation in 2021 resulting from the remeasurement of deferred tax assets.
Adjusted EPS was 139.7p compared with 110.3p in 2021, up 27% at AER, 15% at CER on a 13% CER turnover increase. Operating leverage from growth in sales of Specialty Medicines including HIV and Vaccines, beneficial mix and lower inventory adjustments and write-offs, higher royalty income and a lower effective tax rate was partly offset by increased investment behind launches in Specialty Medicines including HIV and Vaccines plus higher supply chain costs, freight and distribution costs and higher non-controlling interests. Growth in lower margin COVID-19 solutions sales reduced Adjusted EPS growth by 4% AER and 3% CER.
Profit and earnings per share from discontinued operations
Discontinued operations include the Consumer Healthcare business and certain Corporate costs directly attributable to the Consumer Healthcare business. Profit after taxation from discontinued operations amounted to £10,700 million (2021: £1,580 million). This includes £10,084 million for the gain arising on the demerger of Consumer Healthcare split between the amount distributed to shareholders on demerger of £7,651 million and profit after taxation on discontinued operations for the retained stake of £2,433 million. In addition, the Profit after taxation from discontinued operations for the Consumer Healthcare business was £616 million (2021: £1,580 million).
EPS from discontinued operations was 260.6p, compared with 26.7p in 2021. The increase primarily reflected the gain arising on the demerger of the Consumer Healthcare business. For further details see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below, discontinued operations.
26
Table of Contents
Total earnings per share
Total EPS was 371.4p compared with 109.6p in 2021. The increase primarily reflected the profit after taxation for discontinued operations recognised on the Consumer Healthcare business demerger, upfront income received from the settlement with Gilead, increased profits and fair value gains on investments, partly offset by higher remeasurement charges for contingent consideration liabilities and an unfavourable comparison due to a credit of £397 million to Taxation in 2021.
Dividends
The Board has declared four interim dividends resulting in a total dividend for the year of 61.25p per share retrospectively adjusted for the share consolidation. The 2021 dividend per share was 100p retrospectively adjusted for the share consolidation. See “Note 16 – Dividends”, to the financial statements incorporated by reference in Item 18 below.
Dividend policy
On 23 June 2021, at the new GSK Investor Update, GSK set out that from 2022 a progressive dividend policy will be implemented guided by a 40 to 60 percent pay-out ratio through the investment cycle. The dividend policy, the total expected cash distribution, and the respective dividend pay-out ratios for GSK remain unchanged.
GSK has previously stated that it expected to declare a 27p per share dividend for the first half of 2022, a 22p per share dividend for the second half of 2022 and a 45p per share dividend for 2023 (before the Share Consolidation) but that these targeted dividends per share would increase in step with the Share Consolidation to maintain the same aggregate dividend pay-out in absolute Sterling terms. Accordingly, using the consolidation ratio, GSK’s expected dividend for the fourth quarter of 2022 converts to 13.75p per new ordinary share. This results in an expected total dividend for the second half of 2022 of 27.5p per new ordinary share. The expected dividend for 2023 converts to 56.5p per new ordinary share in line with the original expectation converted for the Share Consolidation and rounded up.
COVID-19 solutions
Based on known binding agreements with governments, GSK does not anticipate any significant COVID-19 pandemic-related sales or operating profit in 2023. Sales of COVID-19 solutions were £2.4 billion in 2022 and therefore we expect a reduction in Turnover growth by approximately 9% and a reduction in Adjusted Operating profit growth by 6% to 7%. However, the Company continues to discuss future opportunities to support governments, healthcare systems, and patients whereby its COVID-19 solutions can address the emergence of any new COVID-19 variant of concern.
Profit from discontinued operations
Discontinued operations include the Consumer Healthcare business and certain Corporate costs directly attributable to the Consumer Healthcare business. Profit after taxation from discontinued operations amounted to £10,700 million (2021: £1,580 million). This includes £10,084 million for the gain arising on the demerger of Consumer Healthcare split between the amount distributed to shareholders on demerger of £7,651 million and profit after taxation on discontinued operations for the retained stake of £2,433 million. In addition, the Profit after taxation from discontinued operations for the Consumer Healthcare business was £616 million (2021: £1,580 million).
Intangible asset amortisation
See “Note 20 – Other intangible assets” to the financial statements incorporated by reference in Item 18 below for description and information on Intangible asset amortisation.
Intangible asset impairment
See “Note 20 – Other intangible assets” to the financial statements incorporated by reference in Item 18 below for description and information on Intangible asset impairment. No individual intangible asset accounted for a material impairment.
Major restructuring and integration
Within the Pharmaceuticals sector, the highly regulated manufacturing operations and supply chains and long life cycle of the business mean that restructuring programmes, particularly those that involve the rationalisation or closure of manufacturing or RD sites are likely to take several years to complete.
Major restructuring costs are those related to specific Board-approved Major restructuring programmes and are excluded from Adjusted results. Major restructuring programmes, including integration costs following material acquisitions, are those that are structural and are of a significant scale where the costs of individual or related projects exceed £25 million. Other ordinary course smaller-scale restructuring costs are retained within Total and Adjusted results.
Total Major restructuring charges incurred in 2022 were £321 million (2021(1): £424 million), analysed as follows:
| 2022 | 2021(1) | |||||||||||||||||||||||
| Cash £m |
Non- cash £m |
Total £m |
Cash £m |
Non- cash £m |
Total £m |
|||||||||||||||||||
| Separation preparation restructuring programme |
177 | 110 | 287 | 353 | 59 | 412 | ||||||||||||||||||
| Significant acquisitions |
20 | — | 20 | — | — | — | ||||||||||||||||||
| Legacy programmes |
9 | 5 | 14 | 32 | (20 | ) | 12 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| 206 | 115 | 321 | 385 | 39 | 424 | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| (1) | The 2021 comparative results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
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Table of Contents
Cash charges of £177 million under the Separation Preparation programme primarily arose from the restructuring of some administrative functions as well as Global Supply Chain, RD functions and commercial. The non-cash charges of £110 million primarily reflected the write-down of assets in administrative and manufacturing locations and impairment of IT assets.
Total cash payments made in 2022 were £388 million (2021: £551 million), £332 million (2021: £428 million) relating to the Separation Preparation restructuring programme, £17 million relating to significant acquisitions (2021: £nil) and £39 million (2021: £123 million) relating to other legacy programmes including the settlement of certain charges accrued in previous quarters.
The analysis of Major restructuring charges by income statement line was as follows:
| 2022 £m |
2021(1) £m |
|||||||
| Cost of sales |
102 | 102 | ||||||
| Selling, general and administration |
180 | 277 | ||||||
| Research and development |
39 | 45 | ||||||
|
|
|
|
|
|||||
| Total Major restructuring costs from continuing operations |
321 | 424 | ||||||
|
|
|
|
|
|||||
| (1) | The 2021 comparative results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
The benefit in 2022 from restructuring programmes was £0.5 billion, primarily relating to the Separation Preparation restructuring programme. The Group initiated in Q1 2020 a Separation Preparation programme to prepare for the separation of GSK into two companies: The programme aims were:
| • | Drive a common approach to RD with improved capital allocation |
| • | Align and improve the capabilities and efficiency of global support functions to support GSK |
| • | Further optimise the supply chain and product portfolio, including the divestment of non-core assets |
| • | Prepare Consumer Healthcare to operate as a standalone company |
The programme delivered £0.9 billion of annual savings by 2022 and targets to deliver £1.0 billion by 2023, with total costs estimated at £2.4 billion, of which £1.6 billion is expected to be cash costs. The proceeds of divestments have largely covered the cash costs of the programme.
Transaction-related adjustments
Transaction-related adjustments from continuing operations resulted in a net charge of £1,750 million (2021: £1,143 million). This included a net £1,726 million accounting charge for the re-measurement of the contingent consideration liabilities and the liabilities for the Pfizer put option and Pfizer and Shionogi preferential dividends in ViiV Healthcare.
| Charge/(credit) |
2022 £m |
2021(1) £m |
||||||
| Contingent consideration on former Shionogi-ViiV Healthcare Joint Venture (including Shionogi preferential dividends) |
1,431 | 1,026 | ||||||
| ViiV Healthcare put options and Pfizer preferential dividends |
85 | 48 | ||||||
| Contingent consideration on former Novartis Vaccines business |
193 | 27 | ||||||
| Contingent consideration on acquisition of Affinivax |
17 | — | ||||||
| Other adjustments |
24 | 42 | ||||||
|
|
|
|
|
|||||
| Total transaction-related charges |
1,750 | 1,143 | ||||||
|
|
|
|
|
|||||
| (1) | The 2021 comparative results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
The £1,431 million charge relating to the contingent consideration for the former Shionogi-ViiV Healthcare joint venture represented an increase in the valuation of the contingent consideration due to Shionogi, as a result of the unwind of the discount for £410 million and a charge of £1,021 million primarily from adjustments to sales forecasts and the settlement with Gilead as well as updated exchange rate assumptions. The £85 million charge relating to the ViiV Healthcare put option and Pfizer preferential dividends represented an increase in the valuation of the put option as a result of the settlement with Gilead, offset by lower cash and updated exchange rate assumptions.
The ViiV Healthcare contingent consideration liability is fair valued under IFRS. An explanation of the accounting for the non-controlling interests in ViiV Healthcare is set out on pages 19 to 20 above.
Divestments, significant legal charges and other items
Divestments, significant legal charges and other items primarily included the £922 million upfront settlement income received from Gilead, a fair value gain on investments including £229 million on the retained stake in Haleon as well as milestone income and gains from a number of asset disposals, partly offset by certain other Adjusting items.
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Discontinued operations
From Q2 2020, the Group started to report additional costs to prepare for establishment of the Consumer Healthcare business as an independent entity (“Separation costs”). These are presented as part of discontinued operations. Total separation costs incurred in 2022 were £366 million (2021: £314 million). This includes £103 million relating to transaction costs incurred in connection with the demerger and preparatory admission costs related to the listing of Haleon.
Total separation costs to date are £748 million including £141 million relating to transaction costs.
Cash generation and conversion
A summary of the consolidated cash flow statement is set out below.
| 2022 £m |
2021 £m |
|||||||
| Total net cash inflow from operating activities |
7,403 | 7,952 | ||||||
| Total net cash (outflow) from investing activities |
(8,772 | ) | (1,777 | ) | ||||
| Total net cash inflow/(outflow) from financing activities |
823 | (7,589 | ) | |||||
|
|
|
|
|
|||||
| Decrease in cash and bank overdrafts |
(546 | ) | (1,414 | ) | ||||
|
|
|
|
|
|||||
| Cash and bank overdrafts at beginning of year |
3,819 | 5,262 | ||||||
| Exchange adjustments |
152 | (29 | ) | |||||
| Decrease in cash and bank overdrafts |
(546 | ) | (1,414 | ) | ||||
|
|
|
|
|
|||||
| Cash and bank overdrafts at end of year |
3,425 | 3,819 | ||||||
|
|
|
|
|
|||||
| Cash and bank overdrafts at end of year comprise: |
||||||||
| Cash and cash equivalents |
3,723 | 4,274 | ||||||
| Overdrafts |
(298 | ) | (455 | ) | ||||
|
|
|
|
|
|||||
| 3,425 | 3,819 | |||||||
|
|
|
|
|
|||||
Total net cash inflow from operating activities
Total net cash generated from operating activities for the year was £7,403 million (2021: £7,952 million).
The decrease primarily reflected unfavourable timing of profit share payments for Xevudy sales, increased cash contributions to UK pension schemes, increased contingent consideration payments for the settlement with Gilead and to Shionogi, plus a higher increase in inventory and a reduction in cash from discontinued operations. The decrease was primarily offset by a significant increase in operating profit including the upfront income from the settlement with Gilead, favourable exchange impact and favourable timing of collections.
Reconciliation of net cash inflow from continuing operating activities to free cash inflow
A reconciliation of net cash inflow from operating activities, which is the closest equivalent IFRS measure to free cash flow, is shown below.
| 2022 £m |
2021(1) £m |
|||||||
| Net cash inflow from continuing operating activities |
6,634 | 6,277 | ||||||
| Purchase of property, plant and equipment |
(1,143 | ) | (950 | ) | ||||
| Purchase of intangible assets |
(1,115 | ) | (1,704 | ) | ||||
| Proceeds from sale of property, plant and equipment |
146 | 132 | ||||||
| Proceeds from sale of intangible assets |
196 | 641 | ||||||
| Net finance costs |
(784 | ) | (758 | ) | ||||
| Dividends from joint ventures and associates |
6 | 9 | ||||||
| Contingent consideration paid (reported in investing activities) |
(79 | ) | (114 | ) | ||||
| Contribution from non-controlling interests |
8 | 7 | ||||||
| Distributions to non-controlling interests |
(521 | ) | (239 | ) | ||||
|
|
|
|
|
|||||
| Free cash inflow |
3,348 | 3,301 | ||||||
|
|
|
|
|
|||||
| (1) | The 2021 comparative results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
Capital expenditure and financial investment
Cash payments for tangible and intangible fixed assets amounted to £2,258 million (2021: £2,654 million) and disposals realised £342 million (2021: £773 million). Cash payments to acquire equity investments amounted to £143 million (2021: £162 million) and sales of equity investments realised £238 million (2021: £202 million).
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Free cash flow
Free cash flow is the amount of cash generated by the Group after meeting our obligations for contingent consideration, interest, tax and dividends paid to non-controlling interests, and after capital expenditure on property, plant and equipment and intangible assets.
| 2022 £m |
2021(1) £m |
|||||||
| Free cash inflow |
3,348 | 3,301 | ||||||
|
|
|
|
|
|||||
| (1) | The 2021 comparative results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
Total cash payments to Shionogi in relation to the ViiV Healthcare contingent consideration liability in the year were £1,100 million (2021: £826 million), of which £1,031 million was recognised in cash flows from operating activities and £69 million was recognised in contingent consideration paid within investing cash flows. These payments are deductible for tax purposes.
Future cash flow
Over the long term, we expect that future cash generated from operations will be sufficient to fund our operating and debt servicing costs, normal levels of capital expenditure, obligations under existing licensing agreements, expenditure arising from restructuring programmes and other routine outflows including tax, pension contributions and dividends, subject to the “Principal risks and uncertainties” discussed under Item 3.D “Risk Factors” above. We may from time to time have additional demands for finance, such as for acquisitions. We have access to multiple sources of liquidity from short and long-term capital markets and financial institutions for such needs, in addition to the cash flow from operations.
Investment appraisal and capital allocation
We have a strong framework for capital allocation, including a board to govern the allocation of capital between our businesses. We utilise a consistent cash return on invested capital (CROIC) methodology to prioritise investment across the Group as a whole, so that we can more effectively compare the returns from each of the businesses as we allocate capital between them. We also consider the impact on EPS and our credit profile where relevant.
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Financial position and resources
| 2022 £m |
2021 £m |
|||||||
| Assets |
||||||||
| Non-current assets |
||||||||
| Property, plant and equipment |
8,933 | 9,932 | ||||||
| Right of use assets |
687 | 740 | ||||||
| Goodwill |
7,046 | 10,552 | ||||||
| Other intangible assets |
14,318 | 30,079 | ||||||
| Investments in associates and joint ventures |
74 | 88 | ||||||
| Other investments |
1,467 | 2,126 | ||||||
| Deferred tax assets |
5,658 | 5,218 | ||||||
| Derivative financial instruments |
— | 18 | ||||||
| Other non-current assets |
1,194 | 1,676 | ||||||
|
|
|
|
|
|||||
| Total non-current assets |
39.377 | 60,429 | ||||||
|
|
|
|
|
|||||
| Current assets |
||||||||
| Inventories |
5,146 | 5,783 | ||||||
| Current tax recoverable |
405 | 486 | ||||||
| Trade and other receivables |
7,053 | 7,860 | ||||||
| Derivative financial instruments |
190 | 188 | ||||||
| Current equity investments |
4,087 | — | ||||||
| Liquid investments |
67 | 61 | ||||||
| Cash and cash equivalents |
3,723 | 4,274 | ||||||
| Assets held for sale |
98 | 22 | ||||||
|
|
|
|
|
|||||
| Total current assets |
20,769 | 18,674 | ||||||
|
|
|
|
|
|||||
| Total assets |
60,146 | 79,103 | ||||||
|
|
|
|
|
|||||
| Liabilities |
||||||||
| Current liabilities |
||||||||
| Short-term borrowings |
(3,952 | ) | (3,601 | ) | ||||
| Contingent consideration liabilities |
(1,289 | ) | (958 | ) | ||||
| Trade and other payables |
(16,263 | ) | (17,554 | ) | ||||
| Derivative financial instruments |
(183 | ) | (227 | ) | ||||
| Current tax payable |
(471 | ) | (489 | ) | ||||
| Short-term provisions |
(652 | ) | (841 | ) | ||||
|
|
|
|
|
|||||
| Total current liabilities |
(22,810 | ) | (23,670 | ) | ||||
|
|
|
|
|
|||||
| Non-current liabilities |
||||||||
| Long-term borrowings |
(17,035 | ) | (20,572 | ) | ||||
| Corporation tax payable |
(127 | ) | (180 | ) | ||||
| Deferred tax liabilities |
(289 | ) | (3,556 | ) | ||||
| Pensions and other post-employment benefits |
(2,579 | ) | (3,113 | ) | ||||
| Other provisions |
(532 | ) | (630 | ) | ||||
| Derivative financial instruments |
— | (1 | ) | |||||
| Contingent consideration liabilities |
(5,779 | ) | (5,118 | ) | ||||
| Other non-current liabilities |
(899 | ) | (921 | ) | ||||
|
|
|
|
|
|||||
| Total non-current liabilities |
(27,240 | ) | (34,091 | ) | ||||
|
|
|
|
|
|||||
| Total liabilities |
(50,050 | ) | (57,761 | ) | ||||
|
|
|
|
|
|||||
| Net assets |
10,096 | 21,342 | ||||||
|
|
|
|
|
|||||
| Total equity |
10,096 | 21,342 | ||||||
|
|
|
|
|
|||||
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Table of Contents
Property, plant and equipment
Our business is science-based, technology-intensive and highly regulated by governmental authorities. We allocate significant financial resources to the renewal and maintenance of our property, plant, equipment and vehicles to minimise risks of interruption to production and to ensure compliance with regulatory standards. A number of our processes use hazardous materials.
The total cost of our property, plant and equipment at 31 December 2022 was £19,451 million, with a net book value of £8,933 million. Of this, land and buildings represented £3,113 million, plant, equipment and vehicles £4,012 million and assets in construction £1,808 million. In 2022, we invested £1,245 million in new property, plant and equipment. This was mainly related to a large number of projects for the renewal, improvement and expansion of facilities at various worldwide sites to support new product development and launches as well as to improve the efficiency of existing supply chains. Property is mainly held freehold. New investment is financed from our liquid resources. At 31 December 2022, we had contractual commitments for future capital expenditure of £743 million. We believe that our property and plant facilities are adequate for our current requirements.
We observe stringent procedures and use specialist skills to manage environmental risks from our activities. Environmental issues, sometimes dating from operations now modified or discontinued, are reported under ‘Environment’ on pages 45 and 46 of the GSK Annual Report 2022 and in “Note 47 – Legal Proceedings” to the financial statements incorporated by reference in Item 18 below.
Right of use assets
Right of use assets amounted to £687 million at 31 December 2022 compared with £740 million at 31 December 2021. The decrease in the year reflected the impact of depreciation and transfer to assets held for sale/distribution of £192 million and £127 million respectively, disposals and impairments amounting to £75 million, partly offset by additions through business combinations of £53 million and other additions of £233 million.
Goodwill
Goodwill decreased to £7,046 million at 31 December 2022, from £10,552 million primarily as a result of transfer of assets held for sale/distribution of £5,183 million for the Consumer Healthcare demerger partially offset by an increase of £1,127 million for the acquisitions of Sierra Oncology and Affinivax. The values for Affinivax are provisional and are subject to change.
Other intangible assets
Other intangible assets include the cost of intangibles acquired from third parties and computer software. The net book value of other intangible assets as at 31 December 2022 was £14,318 million (2021: £30,079 million). The decrease primarily reflected transfer to assets held for sale/distribution of £20,057 million, impairment losses, net of reversals and amortisation of £1,519 million, offset by additions, net of disposals, write-offs of £4,047 million and exchange rate gains of £1,628 million.
Investments in associates and joint ventures
We held investments in associates and joint ventures with a carrying value at 31 December 2022 of £74 million (2021: £88 million). See “Note 21 – Investments in associates and joint ventures” to the financial statements incorporated by reference in Item 18 below for more details.
Current equity investments
Current equity investments amounted to £4,087 million at 31 December 2022 (2021: £nil). Current equity investments comprise equity investments which the Group holds with the intention to sell and which it may sell in the short term. Where acquired with this intention, they are measured at fair value through the profit and loss (FVTPL). They are initially recorded at fair value plus transaction costs and then remeasured at subsequent reporting dates to fair value. Unrealised gains and losses are recognised in the income statement. The investment of £4,087 million (2021: £nil) represents the shares held in Haleon after the demerger.
Other investments
We held other investments with a carrying value at 31 December 2022 of £1,467 million (2021: £2,126 million). The most significant of these investments held at 31 December 2022 were in Vir Biotechnology and Nimbus Discovery. These investments had a fair value at 31 December 2022 of £180 million (2021: £266 million) and £139 million (2021: £32 million) respectively. The other investments included equity stakes in companies with which we have research collaborations, and which provide access to biotechnology developments of potential interest and interests in companies that arise from business divestments.
Derivative financial instruments: assets
We held current derivative financial assets at fair value of £190 million (2021: £188 million) and non-current derivative financial assets held at fair value of £nil (2021: £18 million). The majority of these financial instruments related to foreign exchange contracts both designated and not designated as accounting hedges.
Inventories
Inventories amounted to £5,146 million (2021: £5,783) at 31 December 2022. The decrease was mainly driven by the Consumer Healthcare demerger partially offset by vaccines stock build.
Trade and other receivables
Trade and other receivables amounted to £7,053 million (2021: £7,860 million) at 31 December 2022. The decrease was mainly driven by the Consumer Healthcare demerger and lower pandemic adjuvant sales compared to last year.
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Deferred tax assets
Deferred tax assets amounted to £5,658 million (2021: £5,218 million) at 31 December 2022.
Derivative financial instruments: liabilities
We held current and non-current derivative financial liabilities at fair value of £183 million (2021: £228 million). This primarily related to foreign exchange contracts both designated and not designated as accounting hedges.
Trade and other payables
At 31 December 2022, trade and other payables were £16,263 million compared with £17,554 million at 31 December 2021. See “Note 29 – Trade and other payables” to the financial statements incorporated by reference in Item 18 below. The decrease was mainly driven by the Consumer Healthcare demerger and profit share collaborations offset by an increase in promotional activity in the regions.
Provisions
We carried deferred tax provisions and other short-term and non-current provisions of £1,473 million at 31 December 2022 (2021: £5,027 million). Other provisions at the year-end included £218 million (2021: £196 million) related to legal and other disputes and £351 million (2021: £652 million) related to Major restructuring programmes. Provision has been made for legal and other disputes, indemnified disposal liabilities, employee related liabilities and the costs of the restructuring programme to the extent that at the balance sheet date a legal or constructive obligation existed and could be reliably estimated.
Pensions and other post-employment benefits
We account for pension and other post-employment arrangements in accordance with IAS 19. The net deficits were £1,356 million (2021: £1,129 million) on pension arrangements and £994 million (2021: £1,243 million) on unfunded post- employment liabilities. See “Note 31 – Pensions and other post-employment benefits” to the financial statements, incorporated by reference in Item 18 below.
Other non-current liabilities
Other non-current liabilities amounted to £899 million at 31 December 2022 (2021: £921 million).
Contingent consideration liabilities
Contingent consideration amounted to £7,068 million at 31 December 2022 (2021: £6,076 million), of which £5,890 million (2021: £5,559 million) represented the estimated present value of amounts payable to Shionogi relating to ViiV Healthcare, £501 million (2021: £nil) represented the estimated present value of contingent consideration payable to the former shareholders of Affinivax and £673 million (2021: £479 million) represented the estimated present value of contingent consideration payable to Novartis related to the Vaccines acquisition.
The liability due to Shionogi was £263 million in respect of preferential dividends. An explanation of the accounting for the non-controlling interests in ViiV Healthcare is set out on pages 19 to 20 above.
Of the total contingent consideration payable (on a post-tax basis) at 31 December 2022, £940 million (2021: £937 million) is expected to be paid within one year. The consideration payable is expected to be paid over a number of years. As a result, the total estimated liabilities are discounted to their present values, on a post-tax basis using post-tax discount rates.
The Shionogi-ViiV Healthcare contingent consideration liability is discounted at 8% and the Novartis Vaccines contingent consideration liability is discounted partly at 7.5% and partly at 8.5%.
Net debt
| 2022 £m |
2021 £m |
|||||||
| Liquid investments |
67 | 61 | ||||||
| Cash and cash equivalents |
3,723 | 4,274 | ||||||
| Short term borrowings |
(3,952 | ) | (3,601 | ) | ||||
| Long term borrowings |
(17,035 | ) | (20,572 | ) | ||||
|
|
|
|
|
|||||
| Net debt the end of the year |
(17,197 | ) | (19,838 | ) | ||||
|
|
|
|
|
|||||
At 31 December 2022, net debt was £17.2 billion, compared with £19.8 billion at 31 December 2021, comprising gross debt of £21.0 billion and cash and liquid investments of £3.8 billion. Net debt reduced by £2.6 billion primarily due to £3.3 billion free cash flow from continuing operations, £0.2 billion disposals of equity investments and £7.2 billion decrease from discontinued operations as result of demerger primarily reflecting £7.1 billion of pre-separation dividends attributable to GSK funded by Consumer Healthcare debt. This was partly offset by purchases of businesses of £3.1 billion, net of cash acquired, reflecting the acquisitions of Sierra Oncology and Affinivax, dividends paid to shareholders of £3.5 billion, net adverse exchange impacts of £1.4 billion from the translation of non-Sterling denominated debt and exchange on other financing items and £0.1 billion purchases of equity investments.
At 31 December 2022, GSK had short-term borrowings (including overdrafts and lease liabilities) repayable within 12 months of £4.0 billion and £1.9 billion repayable in the subsequent year.
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Table of Contents
At 31 December 2022, GSK’s cash and liquid investments were held as follows:
| 2022 £m |
2021 £m |
|||||||
| Bank balances and deposits |
1,324 | 2,825 | ||||||
| US Treasury and Treasury repo only money market funds |
146 | 54 | ||||||
| Liquidity funds |
2,253 | 1,395 | ||||||
|
|
|
|
|
|||||
| Cash and cash equivalents |
3,723 | 4,274 | ||||||
| Liquid investments – government securities |
67 | 61 | ||||||
|
|
|
|
|
|||||
| 3,790 | 4,335 | |||||||
Cash and liquid investments of £3.1 billion (2021: £2.9 billion) were held centrally at 31 December 2022.
The analysis of cash and gross debt after the effects of hedging is as follows:
| 2022 £m |
2021 £m |
|||||||
| Liquid investments |
67 | 61 | ||||||
| Cash and cash equivalents |
3,723 | 4,274 | ||||||
| Gross debt – fixed |
(19,214 | ) | (23,167 | ) | ||||
| – floating |
(1,773 | ) | (1,006 | ) | ||||
|
|
|
|
|
|||||
| Net debt |
(17,197 | ) | (19,838 | ) | ||||
|
|
|
|
|
|||||
Movements in net debt
| 2022 £m |
2021 £m |
|||||||
| Total net debt at beginning of year |
(19,838 | ) | (20,780 | ) | ||||
| Decrease in cash and bank overdrafts |
(7,597 | ) | (2,504 | ) | ||||
| Decrease in liquid investments |
(1 | ) | (18 | ) | ||||
| Net decrease in long-term loans |
569 | — | ||||||
| Net decrease of short-term loans |
4,053 | 2,003 | ||||||
| Repayment of lease liabilities |
202 | 181 | ||||||
| Debt of subsidiary undertaking acquired |
(24 | ) | — | |||||
| Exchange adjustments |
(1,531 | ) | 314 | |||||
| Other non-cash movements |
(207 | ) | (134 | ) | ||||
|
|
|
|
|
|||||
| Decrease/(increase) in net debt from continuing operations |
(4,536 | ) | (158 | ) | ||||
| Decrease/(increase) in net debt from discontinued operations |
7,177 | 1,100 | ||||||
|
|
|
|
|
|||||
| Total net debt at end of year |
(17,197 | ) | (19,838 | ) | ||||
|
|
|
|
|
|||||
Total equity
At 31 December 2022, total equity had decreased from £21,342 million at 31 December 2021 to £10,096 million.
A summary of the movements in equity is set out below:
| 2022 £m |
2021 £m |
|||||||
| Total equity at beginning of year |
21,342 | 20,808 | ||||||
| Total comprehensive income for the year |
14,790 | 4,759 | ||||||
| Non-cash distribution to non-controlling interests |
(2,960 | ) | — | |||||
| Deconsolidation of former subsidiaries |
(3,045 | ) | — | |||||
| Dividends to shareholders |
(3,467 | ) | (3,999 | ) | ||||
| Ordinary shares issued |
25 | 21 | ||||||
| Changes in non-controlling interests |
(20 | ) | — | |||||
| Non-cash dividends to shareholders |
(15,526 | ) | — | |||||
| Hedging gain/loss transferred to non-financial assets |
9 | — | ||||||
| Transaction with non-controlling interest |
— | 10 | ||||||
| Share-based incentive plans |
357 | 367 | ||||||
| Tax on share-based incentive plans |
(8 | ) | 11 | |||||
| Contributions from non-controlling interests |
8 | 7 | ||||||
| Distributions to non-controlling interests |
(1,409 | ) | (642 | ) | ||||
|
|
|
|
|
|||||
| Total equity at end of year |
10,096 | 21,342 | ||||||
|
|
|
|
|
|||||
34
Table of Contents
Share purchases
At 31 December 2022, GSK held 217.1 million shares as Treasury shares (2021: 284.2 million shares), at a cost of £3,798 million (2021: £4,969 million), which has been deducted from retained earnings.
No ordinary shares were repurchased in the period 1 January 2022 to 28 February 2023 and the company does not expect to make any ordinary share repurchases in the remainder of 2023.
In 2022, 77.1 million Treasury shares were transferred to the Employee Share Ownership Plan (ESOP) Trusts, of which 50.3 million shares were transferred prior to the share consolidation. Shares are held by the Trusts to satisfy future exercises of options and awards under the Group share option and award schemes.
A proportion of the shares held by the Trusts are in respect of awards where the rules of the scheme require GSK to satisfy exercises through market purchases rather than the issue of new shares. The shares held by the Trusts are matched to options and awards granted.
At 31 December 2022, the ESOP Trusts held 59.9 million (2021: 23.3 million) GSK shares against the future exercise of share options and share awards. The carrying value of £353 million (2021: £27 million) has been deducted from other reserves. The market value of these shares was £861 million (2021: £371 million).
Contractual obligations and commitments
Financial commitments are summarised in “Note 36 – Commitments” and in “Note 44 – Financial instruments and related disclosures” to the financial statements incorporated by reference in Item 18 below.
The following table sets out our contractual obligations and commitments at 31 December 2022 as they fall due for payment.
| Total | Under 1 yr | 1-3 yrs | 3-5 yrs | 5 yrs+ | ||||||||||||||||
| £m | £m | £m | £m | £m | ||||||||||||||||
| Loans |
20,086 | 3,786 | 3,213 | 2,259 | 10,828 | |||||||||||||||
| Interest on loans |
6,322 | 594 | 1,101 | 961 | 3,666 | |||||||||||||||
| Finance lease obligations |
1,008 | 167 | 328 | 177 | 336 | |||||||||||||||
| Future Finance Charges on leases |
146 | 25 | 41 | 28 | 52 | |||||||||||||||
| Lease contracts that have not yet commenced |
396 | 18 | 42 | 68 | 268 | |||||||||||||||
| Intangible assets |
10,659 | 317 | 590 | 1,616 | 8,136 | |||||||||||||||
| Property, plant equipment |
743 | 612 | 131 | — | — | |||||||||||||||
| Investments |
138 | 51 | 71 | 13 | 3 | |||||||||||||||
| Purchase commitments |
161 | 96 | 61 | 4 | — | |||||||||||||||
| Pensions and post-retirement benefits |
345 | 345 | — | — | — | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
| Total |
40,004 | 6,011 | 5,578 | 5,126 | 23,289 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Commitments in respect of loans and future interest payable on loans are disclosed before taking into account the effect of derivatives.
We have entered into a number of research collaborations to develop new compounds with other pharmaceutical companies. The terms of these arrangements can include upfront fees, equity investments, loans and commitments to fund specified levels of research. In addition, we will often agree to make further payments if future ‘milestones’ are achieved.
As some of these agreements relate to compounds in the early stages of development, the potential obligation to make milestone payments will continue for a number of years if the compounds move successfully through the development process. Generally, the closer the product is to marketing approval, the greater the probability of success. The amounts shown above within intangible assets represent the maximum that would be paid if all milestones were achieved. There was a decrease in the commitments in 2022 as a result of a reduction in outstanding loan commitments.
In connection with the demerger of Consumer Healthcare, the 31 December 2020 pension scheme valuations identified cash funding or technical provisions deficits in three GSK UK Pension Schemes. Scottish limited partnerships (“SLPs”) were established to provide a funding mechanism for each of GSK’s UK defined benefit pension schemes. The SLPs together hold shares representing 7.5% of the total issued share capital of Haleon.
Each pension scheme, through its SLP interest, is entitled to receive a distribution from that SLP in an amount equal to the net proceeds of sales of Haleon shares, and to receive dividend income on Haleon shares, until it has received an aggregate amount equal to an agreed threshold (“Proceeds Threshold”). The Proceeds Thresholds total £1,080 million (as increased by notional interest on the remaining balance from time to time), and payment of this amount would fully fund the cash funding or technical provisions deficits in the three schemes shown by the 31 December 2020 valuations. Once the Proceeds Threshold has been reached the GSK-controlled General Partner of each SLP is entitled to sell the remaining Haleon shares held by the SLP and distribute the proceeds to GSK. As at 31 December 2022, £345 million remains outstanding to the UK Pension Trustees.
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Contingent liabilities
Other contingent liabilities are set out in “Note 35 – Contingent liabilities” to the financial statements incorporated by reference in Item 18 below.
The following table sets out contingent liabilities, comprising performance guarantees, letters of credit and other items arising in the normal course of business, and when they are expected to expire.
| Total | Under 1 yr | 1-3 yrs | 3-5 yrs | 5 yrs+ | ||||||||||||||||
| £m | £m | £m | £m | £m | ||||||||||||||||
| Guarantees |
12 | 8 | 3 | — | 1 | |||||||||||||||
| Other contingent liabilities |
46 | 10 | — | 11 | 25 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
| Total |
58 | 18 | 3 | 11 | 26 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
In the normal course of business, we have provided various indemnification guarantees in respect of business disposals in which legal and other disputes have subsequently arisen. A provision is made where an outflow of resources is considered probable and a reliable estimate can be made of the likely outcome of the dispute and this is included in “Note 32 – Other provisions” to the financial statements incorporated by reference in Item 18 below.
We provide for the outcome of tax, legal and other disputes when an outflow of resources is considered probable and a reliable estimate of the outflow may be made. At 31 December 2022, other than for those disputes where provision has been made, it was not possible to make a reliable estimate of the potential outflow of funds that might be required to settle disputes where the possibility of there being an outflow was more than remote.
The ultimate liability for such matters may vary significantly from the amounts provided and is dependent upon negotiations with the relevant tax authorities and the outcome of litigation proceedings, where relevant. This is discussed further in ‘Principal risks and uncertainties’ under Item 3.D above on pages 3 to 8 above and “Note 47 – Legal proceedings” to the financial statements incorporated by reference in Item 18 below.
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Group Financial Review 2021
2021 Financial performance
Financial performance growth commentary other than for growth in Group turnover is not available at CER without unreasonable effort. Growth in turnover is provided at both AER and CER; growth in all other line items is provided at AER only.
The Total results of the Group are set out below.
| 2021(1) | 2020(1) | Growth | ||||||||||||||||||
| % of | % of | |||||||||||||||||||
| £m | turnover | £m | turnover | £% | ||||||||||||||||
| Turnover |
24,696 | 100 | 24,354 | 100 | 1 | |||||||||||||||
| Cost of sales |
(8,163 | ) | (33.1 | ) | (7,929 | ) | (32.6 | ) | 3 | |||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
| Gross profit |
16,533 | 66.9 | 16,425 | 67.4 | 1 | |||||||||||||||
| Selling, general and administration |
(7,070 | ) | (28.6 | ) | (7,437 | ) | (30.5 | ) | (5 | ) | ||||||||||
| Research and development |
(5,019 | ) | (20.3 | ) | (4,793 | ) | (19.7 | ) | 5 | |||||||||||
| Royalty income |
417 | 1.7 | 321 | 1.3 | 30 | |||||||||||||||
| Other operating (expenses)/income |
(504 | ) | 1,463 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
| Operating profit |
4,357 | 17.6 | 5,979 | 24.6 | (27 | ) | ||||||||||||||
| Net finance costs |
(755 | ) | (842 | ) | ||||||||||||||||
| Loss on disposal of interest in associates |
(36 | ) | ||||||||||||||||||
| Share of after-tax (losses)/profits of associates and joint ventures |
33 | 33 | ||||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||
| Profit before taxation |
3,599 | 5,170 | (30 | ) | ||||||||||||||||
| Taxation |
(83 | ) | (67 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||
| Profit after taxation from continuing operations for the year |
3,516 | 5,103 | (31 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||
| Profit after taxation from discontinued operations and other gains from the demerger |
1,580 | 1,285 | ||||||||||||||||||
| Remeasurement of discontinued operations distributed to shareholders on demerger |
— | — | ||||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||
| Profit after taxation from discontinued operations |
1,580 | 1,285 | 23 | |||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||
| Total profit after taxation for the year |
5,096 | 6,388 | (20 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||
| Profit attributable to non-controlling interests from continuing operations |
200 | 230 | ||||||||||||||||||
| Profit attributable to shareholders from continuing operations |
3,316 | 4,873 | ||||||||||||||||||
| Profit attributable to non-controlling interests from discontinued operations |
511 | 409 | ||||||||||||||||||
| Profit attributable to shareholders from discontinued operations |
1,069 | 876 | ||||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||
| 5,096 | 6,388 | (20 | ) | |||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||
| Total profit attributable to non-controlling interests |
711 | 639 | ||||||||||||||||||
| Total profit attributable to shareholders |
4,385 | 5749 | ||||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||
| 5,096 | 6,388 | (20 | ) | |||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||
| Earnings per share from continuing operations (p) |
82.9p | 122.4p | (32 | ) | ||||||||||||||||
| Earnings per share from discontinued operations (p) |
26.7p | 22.0p | 21 | |||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||
| Total earnings per share (p) |
109.6p | 144.4p | (24 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||
| Earnings per ADS from continuing operations (US$) |
2.29 | 3.16 | ||||||||||||||||||
| Earnings per ADS from discontinued operations (US$) |
0.73 | 0.57 | ||||||||||||||||||
|
|
|
|
|
|||||||||||||||||
| Total earnings per ADS (US$) |
3.02 | 3.73 | ||||||||||||||||||
|
|
|
|
|
|||||||||||||||||
| (1) | The 2021 and 2020 results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
37
Table of Contents
The Adjusted results for the Group are set out below. Reconciliations between Total results and Adjusted results for 2021 and 2020 are set out on pages 12 and 13 above.
| 2021(1) | 2020(1) | Growth | ||||||||||||||||||
| £m | % of turnover |
£m | % of turnover |
£% | ||||||||||||||||
| Turnover |
24,696 | 100 | 24,354 | 100 | 1 | |||||||||||||||
| Cost of sales |
(7,346 | ) | (29.7 | ) | (6,672 | ) | (27.4 | ) | 10 | |||||||||||
| Selling, general and administration |
(6,749 | ) | (27.3 | ) | (7,025 | ) | (28.8 | ) | (4 | ) | ||||||||||
| Research and development |
(4,525 | ) | (18.3 | ) | (4,322 | ) | (17.7 | ) | 5 | |||||||||||
| Royalty income |
417 | 1.6 | 321 | 1.2 | 30 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
| Adjusted(2) operating profit |
6,493 | 26.3 | 6,656 | 27.3 | (2 | ) | ||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
| Adjusted profit attributable to shareholders |
4,415 | 4,554 | (3 | ) | ||||||||||||||||
| Adjusted profit attributable to non-controlling interest |
441 | 481 | ||||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||
| Adjusted profit after tax |
4,856 | 5,035 | (4 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||
| Adjusted earnings per share (p) |
110.3p | 114.4p | (4 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|||||||||||||||
| (1) | The 2021 and 2020 results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
| (2) | Adjusted results are non-IFRS measures excluding discontinued operations and other adjustments that may be considered in addition to, but not as a substitute for, or superior to, information presented in accordance with IFRS. Adjusted results, AER growth, CER growth and other non-IFRS measures are defined below under “Reporting framework”. |
Historical record of Adjusting items
The reconciliations between Total and Adjusted operating profit from continuing operations for 2021(1) and 2020(1) can be summarised as follows:
| 2021(1) £m |
2020(1) £m |
|||||||
| Total operating profit from continuing operations |
4,357 | 5,979 | ||||||
| Intangible amortisation |
761 | 724 | ||||||
| Intangible impairment |
347 | 200 | ||||||
| Major restructuring |
424 | 1,178 | ||||||
| Transaction-related items |
1,143 | 1,237 | ||||||
| Divestments, significant legal and other items |
(539 | ) | (2,662 | ) | ||||
|
|
|
|
|
|||||
| Adjusted results |
6,493 | 6,656 | ||||||
|
|
|
|
|
|||||
| (1) | The 2021 and 2020 results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below) |
The analysis of the impact of transaction-related items on operating profit for each of the last three years is as follows:
| 2021(1) £m |
2020(1) £m |
|||||||
| Contingent consideration on former Shionogi-ViiV Healthcare JV (including Shionogi preferential dividends) |
1,026 | 1,114 | ||||||
| ViiV Healthcare put options and Pfizer preferential dividends |
48 | (52 | ) | |||||
| Contingent consideration on former Novartis Vaccines business |
27 | 172 | ||||||
| Other adjustments |
42 | 3 | ||||||
|
|
|
|
|
|||||
| Transaction-related items |
1,143 | 1,237 | ||||||
|
|
|
|
|
|||||
| (1) | The 2021 and 2020 results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below) |
Full reconciliations between Total and Adjusted results for 2021 and 2020 are set out on pages 12 and 13 above.
Non-controlling interests in ViiV Healthcare
Trading profit allocations
As ViiV Healthcare is a subsidiary of the Group, 100% of its operating results (turnover, operating profit, profit after tax) are included within the Group income statement and then a portion of the earnings is allocated to the non-controlling interests owned by the other shareholders, in line with their respective equity shareholdings (Pfizer, Inc. (Pfizer) 11.7% and Shionogi Co. Ltd (Shionogi) 10%). Each of the shareholders, including GSK, is also entitled to preferential dividends determined by the performance of certain products that each shareholder contributed. As the relative performance of these products changes over time, the proportion of the overall earnings allocated to each shareholder also changes. In particular, the increasing proportion of sales of dolutegravir and cabotegravir-containing products has a favourable impact on the proportion of the preferential dividends that is allocated to GSK. Adjusting items are allocated to shareholders based on their equity interests. GSK was entitled to approximately 86% of the Total earnings and 83% of the Adjusted earnings of ViiV Healthcare for 2021. Remeasurements of the liabilities for the preferential dividends allocated to Pfizer and Shionogi are included within other operating income/(expense).
38
Table of Contents
Acquisition-related arrangements
As consideration for the acquisition of Shionogi’s interest in the former Shionogi-ViiV Healthcare joint venture in 2012, Shionogi received the 10% equity stake in ViiV Healthcare and ViiV Healthcare also agreed to pay additional future cash consideration to Shionogi, contingent on the future sales performance of the products being developed by that joint venture, dolutegravir and cabotegravir. Under IFRS 3 ‘Business combinations’, GSK was required to provide for the estimated fair value of this contingent consideration at the time of acquisition and is required to update the liability to the latest estimate of fair value at each subsequent period end. The liability for the contingent consideration recognised in the balance sheet at the date of acquisition was £659 million. Subsequent re-measurements are reflected within other operating income/(expense) and within Adjusting items in the income statement in each period.
Cash payments to settle the contingent consideration are made to Shionogi by ViiV Healthcare each quarter, based on the actual sales performance and other income of the relevant products in the previous quarter. These payments reduce the balance sheet liability and hence are not recorded in the income statement. The cash payments made to Shionogi by ViiV Healthcare in 2021 were £826 million.
As the liability is required to be recorded at the fair value of estimated future payments, there is a significant timing difference between the charges that are recorded in the Total income statement to reflect movements in the fair value of the liability and the actual cash payments made to settle the liability.
The cash payments are reflected in the cash flow statement partly in operating cash flows and partly within investing activities. The tax relief on these payments is reflected in the Group’s Adjusting items as part of the tax charge. The part of each payment relating to the original estimate of the fair value of the contingent consideration on the acquisition of the Shionogi-ViiV Healthcare joint venture in 2012 of £659 million is reported within investing activities in the cash flow statement and the part of each payment relating to the increase in the liability since the acquisition is reported within operating cash flows.
Movements in contingent consideration payable to Shionogi were as follows:
| 2021 £m |
2020 £m |
|||||||
| Contingent consideration at beginning of the year |
5,359 | 5,103 | ||||||
| Remeasurement through income statement and other movements |
1,026 | 1,114 | ||||||
| Cash payments: operating cash flows |
(721 | ) | (751 | ) | ||||
| Cash payments: investing activities |
(105 | ) | (107 | ) | ||||
|
|
|
|
|
|||||
| Contingent consideration at end of the year |
5,559 | 5,359 | ||||||
|
|
|
|
|
|||||
Of the contingent consideration payable (on a post-tax basis) to Shionogi at 31 December 2021, £937 million (31 December 2020: £745 million) is expected to be paid within one year.
Exit rights
Pfizer may request an IPO of ViiV Healthcare at any time and if either GSK does not consent to such IPO or an offering is not completed within nine months, Pfizer could require GSK to acquire its shareholding. Under the original agreements, GSK had the unconditional right, so long as it made no subsequent distribution to its shareholders, to withhold its consent to the exercise of the Pfizer put option and, as a result, in accordance with IFRS, GSK did not recognise a liability for the put option on its balance sheet. However, during Q1 2016, GSK notified Pfizer that it had irrevocably given up this right and accordingly recognised the liability for the put option on the Group’s balance sheet during Q1 2016 at an initial value of £1,070 million. Consistent with this revised treatment, at the end of Q1 2016 GSK also recognised liabilities for the future preferential dividends anticipated to become payable to Pfizer and Shionogi on the Group’s balance sheet.
Pfizer has the right to require GSK to acquire its shareholding in ViiV Healthcare in certain circumstances at any time. A put option liability is therefore recorded on the Group’s balance sheet as a current liability. It is measured on the gross redemption basis derived from an internal valuation of the ViiV Healthcare business.
The closing balances of the liabilities related to Pfizer’s shareholding are as follows:
| 2021 £m |
2020 £m |
|||||||
| Pfizer put option |
1,008 | 960 | ||||||
|
|
|
|
|
|||||
| Pfizer preferential dividend |
— | 1 | ||||||
|
|
|
|
|
|||||
Under the original agreements, Shionogi could also have requested GSK to acquire its shareholding in ViiV Healthcare in six-month windows commencing in 2017, 2020 and 2022. GSK had the unconditional right, so long as it made no subsequent distribution to its shareholders, to withhold its consent to the exercise of the Shionogi put option and, as a result, GSK did not recognise a liability for the put option on its balance sheet.
However, during Q1 2016, GSK notified Shionogi that it had irrevocably given up this right and accordingly recognised the liability for the put option on the Group’s balance sheet during Q1 2016 at an initial value of £926 million. In Q4 2016, Shionogi irrevocably agreed to waive its put option and as a result GSK de-recognised the liability for this put option on the Group’s balance sheet directly to equity. The value of the liability was £1,244 million when it was de-recognised.
GSK also has a call option over Shionogi’s shareholding in ViiV Healthcare, which under the original agreements was exercisable in six-month windows commencing in 2027, 2030 and 2032. GSK has now irrevocably agreed to waive the first two exercise windows, but the last six-month window in 2032 remains. As this call option is at fair value, it has no value for accounting purposes.
Settlement with Gilead
On 1 February 2022, ViiV Healthcare reached agreement with Gilead to settle the global patent infringement litigation relating to the commercialisation of Gilead’s Biktarvy. Under the terms of the global settlement and licensing agreement, Gilead made an upfront payment of $1.25 billion to ViiV Healthcare in February 2022. In addition, Gilead will also pay a 3% royalty on all future US sales of Biktarvy and in respect of the bictegravir component of any other future bictegravir- containing products sold in the US. These royalties will be payable by Gilead to ViiV Healthcare from 1 February 2022 until the expiry of ViiV Healthcare’s US Patent No. 8,129,385 on 5 October 2027. Gilead’s obligation to pay royalties does not extend into any period of regulatory paediatric exclusivity, if awarded. The settlement resulted in a re- measurement of the existing liabilities for contingent consideration and the Pfizer put option at the 2021 year end.
The impact of the settlement with Gilead on the contingent consideration liability (CCL) was to increase it by £288 million, on a post-tax basis in Q4 2021 due to the obligation ViiV Healthcare has to pay future cash consideration to Shionogi for its share of the upfront and of the future US sales performance of Biktarvy and products containing bictegravir. Including the impact of the settlement at 31 December 2021, the liability which is discounted at 8% stood at £5,559 million, on a post-tax basis.
The impact of the settlement on the Pfizer put option liability was an increase of £114 million and was included in the re-measurement at 31 December 2021.
39
Table of Contents
Reporting definitions
Reporting definitions are set out on pages 20 and 21 above.
Group turnover
| 2021(1) £m |
2020(1) £m |
Growth £% |
Growth CER% |
|||||||||||||
| Specialty Medicines |
8,251 | 6,969 | 18 | 25 | ||||||||||||
| Vaccines |
6,778 | 6,982 | (3 | ) | 2 | |||||||||||
| General Medicines |
9,667 | 10,281 | (6 | ) | (3 | ) | ||||||||||
| Consumer Healthcare(2) |
— | 122 | — | — | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| 24,696 | 24,354 | 1 | 6 | |||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| (1) | The 2021 and 2020 results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below) |
| (2) | Sales of products outside the perimeter of the Consumer Healthcare business related to sale of shares to Hindustan Unilever. |
Group turnover was £24,696 million in 2021, up 1% at AER, 6% at CER compared to 2020. In 2021 sales of COVID-19 solutions contributed growth of 6% at AER and 6% CER.
Specialty Medicines turnover in the year was £8,251 million, up 18% AER, 25% CER. Sales of Xevudy, the monoclonal antibody treatment for COVID-19 of £958 million contributed approximately 15 percentage points to Specialty Medicines growth.
Vaccines turnover in the year decreased 3% at AER but grew 2% at CER to £6,778 million, primarily driven by pandemic adjuvant sales, partially offset by foreign exchange and lower demand for routine adult vaccination due to COVID-19 vaccination programme deployment and disease circulation across regions, resulting in lower Shingrix and Hepatitis vaccines sales. Unfavourable US prior period RAR adjustments reduced overall Vaccines growth by approximately 2 percentage points, particularly in Fluarix/ FluLaval and Shingrix where the impact on product growth was a decrease of 7% and a decrease of 2% respectively.
Sales of pandemic adjuvant contributed 6% at AER, 7% at CER. Excluding these sales Vaccines turnover decreased 9% AER, 5% CER to £6,331 million.
General Medicines in the year decreased 6% at AER and 3% at CER to £9,667 million.
Commercial Operations Innovation sales (sales of products launched in the last five years including lifecycle innovation) amounted to £6,841 million (excluding COVID-19 solutions) in 2021 largely driven by sales of Shingrix, Trelegy, Nucala, Benlysta, Dovato, Juluca, and Zejula.
Specialty Medicines turnover
| 2021(1) (revised) £m |
2020(1) (revised) £m |
Growth £% |
Growth CER% |
|||||||||||||
| HIV |
4,777 | 4,876 | (2 | ) | 3 | |||||||||||
| Oncology |
489 | 372 | 31 | 37 | ||||||||||||
| Immuno-inflammation, respiratory and other |
2,027 | 1,721 | 18 | 25 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| 7,293 | 6,969 | 5 | 10 | |||||||||||||
| Pandemic |
958 | — | ||||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Specialty medicines |
8,251 | 6,969 | 18 | 25 | ||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| (1) | 2021 and 2020 have been revised to reflect changes to product groups previously reported as Established Pharmaceuticals. |
HIV
HIV sales were £4,777 million a decrease of 2% AER but growth of 3% CER for the year. Triumeq sales were £1,882 million, down 18% AER, 14% CER and Tivicay sales were £1,381 million, down 10% AER, 4% CER. The mature portfolio resulted in less than 1 percentage point of CER sales decrease.
New HIV products Juluca, Dovato, Rukobia and Cabenuva delivered sales of £1,387 million representing 29% of the total HIV portfolio (18% in 2020). Sales of the two drug regimens Juluca and Dovato were £517 million and £787 million, respectively, with combined growth of 50% AER, 58% CER. Rukobia sales were £45 million. Cabenuva, the first long acting injectable, recorded £38 million of sales for the full year.
In the US, total sales were £2,898 million with a decrease of 4% AER, but growth of 3% CER. New HIV products delivered sales of £896 million, including: Dovato £428 million with growth of 87% AER, 99% CER, Juluca £393 million with growth of 2% AER, 8% CER, Rukobia £43 million and Cabenuva £32 million. Combined Tivicay and Triumeq sales were £1,953 million declining 16% AER, 11% CER. In Europe, total sales were £1,194 million with a decrease of 2% AER, but growth of 1% CER. New HIV products delivered sales of £420 million, including: Dovato sales of £302 million, which more than doubled at AER and CER, and Juluca £111 million with growth of 14% AER, 18% CER. Combined Tivicay and Triumeq sales were £738 million declining 21% AER, 19% CER. International continued to grow strongly with total sales of £685 million, with growth of 4% AER, 11% CER, driven by the Tivicay tender business and new HIV products.
Oncology
Sales of Zejula, the PARP inhibitor treatment for ovarian cancer were £395 million, up 17% AER, 22% CER, impacted by ongoing lower diagnosis rates due to the COVID-19 pandemic, particularly in the US. Sales included £212 million in the US and £163 million in Europe.
40
Table of Contents
Blenrep for the treatment of patients with relapsed or refractory multiple myeloma was approved and launched in the US and Europe in Q3 2020, with ongoing launches throughout Europe in 2021. Blenrep sales globally totalled £89 million.
Immuno-inflammation, respiratory and other
Immuno-inflammation, respiratory and other sales were £2,027 million, up 18% AER, 25% CER with Benlysta sales up 22% AER, 29% CER to £874 million, benefitting from lupus nephritis launches in US and Japan in H2 2020.
Sales of Nucala were £1,142 million in the year and grew 15% AER, 22% CER, with consistent, strong growth across all three regions. US sales were up 15% AER, 23% CER to £690 million and International sales of £195 million grew 23% AER, 34% CER. Europe sales of £257 million grew 8% AER, 11% CER.
Pandemic sales
Sales of Xevudy were £958 million in the year, reflecting the ongoing fulfilment of contracts across the world and most significantly in the US, which reported sales of £602 million. International recorded sales of £287 million and Europe £69 million.
Vaccines turnover
| 2021 £m |
2020 £m |
Growth £% |
Growth CER% |
|||||||||||||
| Meningitis |
961 | 1,029 | (7 | ) | (2 | ) | ||||||||||
| Influenza |
679 | 733 | (7 | ) | (2 | ) | ||||||||||
| Shingles |
1,721 | 1,989 | (13 | ) | (9 | ) | ||||||||||
| Established Vaccines |
2,970 | 3,231 | (8 | ) | (4 | ) | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| 6,331 | 6,982 | (9 | ) | (5 | ) | |||||||||||
| Pandemic Vaccines |
447 | — | ||||||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| Vaccines |
6,778 | 6,982 | (3 | ) | 2 | |||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
Meningitis
Meningitis sales decreased 7% AER, 2% CER to £961 million driven primarily by unrepeated International tender volumes for other meningitis vaccines. Bexsero sales were stable at AER, but grew 5% CER to £650 million, reflecting increased market share in the US.
Menveo sales were up 3% AER, 9% CER to £272 million, primarily driven by 2020 cohort catch-up vaccinations and 2021 higher demand, as well as increased market share in the US.
Influenza
Fluarix/FluLaval sales decreased 7% AER, 2% CER, to £679 million as a result of unfavourable prior period RAR movements in the US, partially offset by higher volume in the US and strong southern hemisphere demand in International.
Shingles
Shingrix decreased 13% AER, 9% CER to £1,721 million, primarily driven by lower demand in the US and International for routine adult vaccination due to COVID-19 vaccination programme deployment and disease circulation. In Europe, sales growth was driven by Germany and launches in the UK, Spain and Italy. Shingrix was sold in 17 countries, including 9 markets launched during 2021.
Established Vaccines
Hepatitis vaccines sales were down 20% AER, 16% CER to £460 million, adversely impacted by de-prioritisation of routine US adult vaccinations, increased Hepatitis B vaccine competition and unfavourable CDC stockpile movements in the US, and by COVID-19 related travel restrictions in Europe and International.
Sales of DTPa-containing vaccines (Infanrix, Pediarix and Boostrix) decreased 4% AER but grew 1% CER. Infanrix/ Pediarix sales decreased 14% AER, 9% CER to £543 million, reflecting lower tender volume in Europe and International as well as a change in recommendation for the dosing schedule in Germany, partly offset by increased demand in the US. Boostrix sales grew 9% AER, 14% CER to £521 million, largely driven by demand recovery and tender volumes in International, as well as higher demand and share in the US.
Rotarix sales were down 3% AER but up 1% CER to £541 million, reflecting demand recovery in International and foreign exchange impacts.
Synflorix sales decreased by 11% AER, 8% CER to £357 million, primarily due to lower tender demand in Emerging markets. MMRV vaccines sales were stable at AER but grew 4% CER to £260 million, largely driven by higher demand in International.
Pandemic Vaccines
Pandemic vaccines sales of £447 million included £444 million of pandemic adjuvant sales to the US and Canadian governments.
General Medicines turnover
| 2021(1) (revised) £m |
2020(1) (revised) £m |
Growth £% |
Growth CER% |
|||||||||||||
| Respiratory |
6,048 | 6,006 | 1 | 6 | ||||||||||||
| Other general medicines |
3,619 | 4,275 | (15 | ) | (15 | ) | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| General medicines |
9,667 | 10,281 | (6 | ) | (3 | ) | ||||||||||
|
|
|
|
|
|
|
|
|
|||||||||
| (1) | The 2021 and 2020 results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below) |
2021 and 2020 have been revised to reflect changes to product groups previously reported as Established Pharmaceuticals.
41
Table of Contents
Respiratory
Total Respiratory sales were up 1% AER, 6% CER. The performance was driven by Trelegy sales of £1,217 million up 49% AER, 57% CER driven by growth in all regions.
Advair/Seretide sales of £1,357 million continued to be eroded by generic competition, decreasing by 12% at AER, 7% at CER.
Other general medicines
Other General Medicines sales were £3,619 million, down 15% at AER and 15% at CER primarily driven by a decline in Augmentin at 13% AER and 7% CER due to lower demand for antibiotics during the COVID-19 Pandemic period. Avodart which declined 19% at AER and 25% at CER due to loss of exclusivity in Japan and Europe and the divestment of GSK’s cephalosporin products in Q4 2021.
Turnover by regions
US
In the US, sales were £11,914 million, up 7% at AER, 14% at CER. Sales of Xevudy were £602 million.
Europe
In Europe, sales were £5,370 million, down 3% at AER, 1% at CER. Sales of Xevudy were £69 million.
International
International sales were £7,412 million, down 3% at AER, up 2% at CER. Sales of Xevudy were £287 million.
Cost of sales
| 2021(1) £m |
2020(1) £m |
Growth £% |
||||||||||
| Total cost of sales |
(8,163 | ) | (7,929 | ) | 3 | |||||||
| Adjusted cost of sales |
(7,346 | ) | (6,672 | ) | 10 | |||||||
|
|
|
|
|
|
|
|||||||
| (1) | The 2021 and 2020 results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
Total cost of sales as a percentage of turnover was 33.1%, 0.5 percentage points higher at AER than 2020.
Adjusted cost of sales as a percentage of turnover was 29.7%, 2.3 percentage points higher at AER compared with 2020. This primarily reflected higher pandemic sales (Xevudy) as well as higher supply chain costs in Vaccines resulting from lower demand and higher inventory adjustments, partly offset by price benefits, including the benefit from prior period RAR adjustments, a further contribution from restructuring savings across the business and favourable mix in Vaccines.
Selling, general and administration
| 2021(1) £m |
2020(1) £m |
Growth £% |
||||||||||
| Total selling, general and administration |
(7,070 | ) | (7,437 | ) | (5 | ) | ||||||
| Adjusted selling, general and administration |
(6,749 | ) | (7,025 | ) | (4 | ) | ||||||
|
|
|
|
|
|
|
|||||||
| (1) | The 2021 and 2020 results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
Total SGA costs as a percentage of turnover were 28.6%, 1.9 percentage points lower at AER compared to 2020. This included a reduction in restructuring charges.
Adjusted SGA costs as a percentage of turnover were 27.3%, 1.5 percentage points lower at AER than in 2020. Adjusted SGA costs decreased 4% at AER which reflected the tight control of ongoing costs and reduced variable spending across all three businesses as a result of the COVID-19 lockdowns, and the continuing benefit of restructuring in Commercial Operations and support functions. The decrease also reflected a favourable legal settlement in 2021 compared to increased legal costs in 2020 as well as one-off benefits in pensions and insurance which were partly offset by the one-off benefit from restructuring of post- retirement benefits in 2020. This was partly offset by increased investment behind launches in HIV and Vaccines.
Research and development
| 2021(1) £m |
2020(1) £m |
Growth £% |
||||||||||
| Total research and development |
(5,019 | ) | (4,793 | ) | 5 | |||||||
| Adjusted research and development |
(4,525 | ) | (4,322 | ) | 5 | |||||||
|
|
|
|
|
|
|
|||||||
| (1) | The 2021 and 2020 results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
Total RD expenditure was £5,019 million up 5% at AER including an increase in impairments partly offset by a decrease in major restructuring charges.
Adjusted RD expenditure increased by 5% at AER to £4,525 million (18.3% of turnover), up 4% at AER, primarily driven by increased investment in our Specialty portfolios, including the early stage research projects. Efficiency savings continued from the implementation of the One RD programme for Research and Development as part of the Separation preparation restructuring programme.
42
Table of Contents
The growth of the Specialty portfolio in 2021 was primarily driven by our two programmes for COVID-19 treatment (Xevudy and otilimab) along with the other otilimab programme for rheumatoid arthritis, bepirovirsen, our HBV antisense oligonucleotide and depemokimab, our anti-IL5 for asthma. This has been partly offset by reduced spend on daprodustat due to the completion of programmes. In Oncology, there is continued investment reflecting our commitment to synthetic lethality and in Blenrep, together with bintrafusp alfa, where we have accelerated close-out costs for the programme but this has been largely offset by a reduction in spend on feladilimab following the decision to terminate the programme in April. Vaccines increased investment in clinical programmes for meningitis and RSV and investment in our mRNA platform, partly offset by efficiency savings from the implementation of the One Development programme and variable spending as a result of COVID-19 lockdowns.
Royalty income
Royalty income was £417 million (2020: £321 million), up 30% AER primarily driven by higher sales of Gardasil.
Other operating income/(expense)
Net other operating expenses of £504 million (2020: £1,463 million income) primarily reflected accounting charges of £1,101 million (2020: £1,234 million) arising from the re-measurement of the contingent consideration liabilities related to the acquisitions of the former Shionogi-ViiV Healthcare joint venture and the former Novartis Vaccines business and the liabilities for the Pfizer put option and Pfizer and Shionogi preferential dividends in ViiV Healthcare. This included a re-measurement charge of £1,026 million (2020: £1,114 million) for the contingent consideration liability due to Shionogi, as a result of the unwinding of the discount for £380 million and a charge for £646 million primarily from adjustments to sales forecasts and the settlement with Gilead (see “Settlement with Gilead Sciences Inc. (Gilead)” above). This was partly offset by a number of asset disposals including the disposal of royalty rights on cabozantinib, the disposal of the cephalosporin business and fair value uplifts on investments. 2020 included the net profit on disposal of Horlicks and other Consumer Healthcare brands of £2,815 million, partly offset by the related loss on sale of the shares in Hindustan Unilever of £476 million.
Operating profit
Total operating profit was £4,357 million compared with £5,979 million in 2020. This primarily reflected an unfavourable comparison to the net profit on disposal in Q2 2020 of Horlicks and other Consumer brands and resultant sale of shares in Hindustan Unilever. This was partly offset by lower major restructuring costs and lower re-measurement charges on the contingent consideration liabilities. Total operating margin was 17.6%.
Excluding these and other Adjusting items, Adjusted operating profit was £6,493 million, 2% lower than 2020 at AER, on a turnover increase of 1% AER. The Adjusted operating margin of 26.3% was 1.0 percentage points lower at AER.
The decrease in Adjusted operating profit reflected foreign exchange, lower sales in Vaccines, primarily Shingrix, higher supply chain costs in Vaccines and increased investment in RD across Vaccines and Specialty Medicines. This was partially offset by the benefit from incremental pandemic sales (Xevudy and adjuvant) contributing approximately 9% AER to Adjusted Operating profit growth. Adjusted Operating profit also benefited from sales growth in Commercial Operations including the benefit from prior period RAR adjustments and tight control of ongoing costs including reduced promotional and variable spending across all the business as a result of the COVID-19 lockdowns, favourable legal settlements compared to increased legal costs in 2020 and benefits from continued restructuring across the business.
Contingent consideration cash payments which are made to Shionogi and other companies reduce the balance sheet liability and hence are not recorded in the income statement.
Total contingent consideration cash payments in 2021 amounted to £856 million (2020: £885 million). This included cash payments made to Shionogi of £826 million (2020: £858 million).
Adjusted operating profit by business
Commercial Operations operating profit was £11,467 million, up 2% AER on a turnover increase of 2% AER. The operating margin of 46.4% was 0.2 percentage points lower at AER than in 2020. This primarily reflected price benefits in Commercial Operations, including the benefit from a prior period RAR adjustment, the tight control of ongoing costs, short term benefits to changes in ways of working, a favourable legal settlement in 2021 compared to increased legal costs in 2020, increased royalty income and the continuing benefit of restructuring. This was partly offset by support to launches in HIV and Vaccines and higher supply chain costs in Vaccines.
Research and Development operating expenses were £4,567 million, up 4% AER primarily driven by increased investment in our Specialty portfolios, including the early stage research projects.
Net finance costs
| Finance income |
2021(1) £m |
2020(1) £m |
||||||
| Interest and other income |
13 | 26 | ||||||
| Fair value movements |
1 | 6 | ||||||
|
|
|
|
|
|||||
| 14 | 32 | |||||||
|
|
|
|
|
|||||
| Finance expense |
||||||||
| Interest expense |
(735 | ) | (813 | ) | ||||
| Unwinding of discounts on provisions |
(2 | ) | (3 | ) | ||||
| Remeasurements and fair value movements |
(2 | ) | (2 | ) | ||||
| Finance expense on lease liabilities |
(27 | ) | (33 | ) | ||||
| Other finance expense |
(3 | ) | (23 | ) | ||||
|
|
|
|
|
|||||
| (769 | ) | (874 | ) | |||||
|
|
|
|
|
|||||
| (1) | The 2021 and 2020 results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
Total net finance costs were £755 million compared with £842 million in 2020. Adjusted net finance costs were £752 million compared with £838 million in 2020. The decrease is primarily as a result of reduced interest expense from lower debt levels, favourable movements in foreign exchange rates, a premium paid on the early repayment and refinancing of bond debt in 2020 and reduced interest on tax partly offset by lower interest income on overseas cash post-closing of the divestment of Horlicks and other Consumer Healthcare nutrition products in India and a number of other countries.
Share of after tax profits of associates and joint ventures
The share of after tax profits of associates and joint ventures was £33 million (2020 – £33 million).
43
Table of Contents
Loss on disposal of interest in associates
The net loss on disposal of interests in associates was £36 million, primarily driven by a loss on disposal of our interest in the associate Innoviva Inc.
Profit before tax
Taking account of net finance costs, the share of profits of associates and loss on disposal of interest in associates, profit before taxation was £3,599 million compared with £5,170 million in 2020.
Taxation
| 2021(1) £m |
2020(1) £m |
|||||||
| UK current year charge |
119 | (45 | ) | |||||
| Rest of world current year charge |
593 | 745 | ||||||
| Charge/(credit) in respect of prior periods |
219 | 11 | ||||||
|
|
|
|
|
|||||
| Total current taxation |
931 | 711 | ||||||
| Total deferred taxation |
(848 | ) | (644 | ) | ||||
|
|
|
|
|
|||||
| Taxation on total profits |
83 | 67 | ||||||
|
|
|
|
|
|||||
| (1) | The 2021 and 2020 results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
The charge of £83 million represented an effective tax rate on Total results of 2.3% (2020: 1.3%) and reflected the different tax effects of the various Adjusting items, including a credit of £430 million resulting from the revaluation of deferred tax assets following enactment of an increase in the headline rate of UK corporation tax (effective 1 April 2023). 2020 reflected the disposal of Horlicks and other Consumer brands and the subsequent disposal of shares received in Hindustan Unilever. Tax on Adjusted profit amounted to £918 million and represented an effective Adjusted tax rate of 15.9% (2020: 13.9%).
Issues related to taxation are described in Note 14 to the financial statements ‘Taxation’ incorporated by reference in Item 18 below. The Group continues to believe it has made adequate provision for the liabilities likely to arise from periods which are open and not yet agreed by tax authorities. The ultimate liability for such matters may vary from the amounts provided and is dependent upon the outcome of agreements with relevant tax authorities.
Non-controlling interests
The allocation of Total earnings to non-controlling interests amounted to £200 million (2020: £230 million). Allocation of ViiV Healthcare profits was £196 million (2020: £223 million), including reduced credits for re-measurement of contingent consideration liabilities.
The allocation of Adjusted earnings to non-controlling interests amounted to £441 million (2020: £481 million). The reduction in allocation primarily reflected a reduced allocation of ViiV Healthcare profits of £438 million (2020: £474 million), partly offset by higher net profits in some of the Group’s other entities with non-controlling interests.
Earnings per share
Total EPS from continuing operations was 82.9p compared with 122.4p in 2020. This primarily reflected an unfavourable comparison to the net profit on disposal in Q2 2020 of Horlicks and other Consumer Healthcare brands partly offset by the related loss on sale of the shares in Hindustan Unilever, partly offset by a credit of £430 million to Taxation in 2021 resulting from the revaluation of deferred tax assets following enactment of an increase in the headline rate of UK corporation tax (effective 1 April 2023), lower major restructuring costs and lower remeasurement charges on the contingent consideration liabilities.
Adjusted EPS was 110.3p compared with 114.4p in 2020, down 4% AER primarily reflecting foreign exchange, lower sales in Vaccines, primarily Shingrix, higher supply chain costs in Vaccines, increased RD investment and a higher effective tax rate. This was offset by incremental pandemic sales, sales increases in Pharmaceuticals, tight cost control and favourable legal settlements and lower interest costs.
Major restructuring and integration
Within the Pharmaceuticals sector, the highly regulated manufacturing operations and supply chains and long life cycle of the business mean that restructuring programmes, particularly those that involve the rationalisation or closure of manufacturing or RD sites are likely to take several years to complete.
Major restructuring costs are those related to specific Board-approved Major restructuring programmes and are excluded from Adjusted results. Major restructuring programmes, including integration costs following material acquisitions, are those that are structural and are of a significant scale where the costs of individual or related projects exceed £25 million. Other ordinary course smaller-scale restructuring costs are retained within Total and Adjusted results.
Total Major restructuring charges incurred in 2021 were £424 million (2020 – £1,178 million), analysed as follows
| 2021(1) | 2020(1) | |||||||||||||||||||||||
| Cash £m |
Non- cash £m |
Total £m |
Cash £m |
Non- cash £m |
Total £m |
|||||||||||||||||||
| Separation preparation restructuring programme |
353 | 59 | 412 | 624 | 215 | 839 | ||||||||||||||||||
| Legacy programmes |
32 | (20 | ) | 12 | 145 | 194 | 339 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| 385 | 39 | 424 | 769 | 409 | 1,178 | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| (1) | The 2021 and 2020 results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
Cash charges of £353 million under the Separation Preparation programme primarily arose from restructuring of some administrative functions as well as Global Supply chain, RD functions and Commercial. The non-cash charges of £59 million primarily reflected write-down of assets in administrative locations and RD sites.
44
Table of Contents
Total cash payments made in 2021 were £551 million (2020: £435 million), £428 million (2020: £152 million) relating to the Separation Preparation restructuring programme, £123 million (2020: £256 million) relating to other legacy programmes including the settlement of certain charges accrued in previous quarters.
The analysis of Major restructuring charges by income statement line was as follows:
| 2021(1) £m |
2020(1) £m |
|||||||
| Cost of sales |
102 | 585 | ||||||
| Selling, general and administration |
277 | 395 | ||||||
| Research and development |
45 | 198 | ||||||
|
|
|
|
|
|||||
| Total Major restructuring costs from continuing operations |
424 | 1,178 | ||||||
|
|
|
|
|
|||||
| (1) | The 2021 and 2020 results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
The benefit in the 2021 from restructuring programmes was £0.7 billion, the benefit from the Separation Preparation restructuring programme was £0.3 billion and the benefit from the 2018 Restructuring programme was £0.2 billion.
The Group initiated in Q1 2020 a two-year Separation Preparation programme to prepare for the separation of GSK into two companies: new GSK, a biopharma company with an RD approach focused on science related to the immune system, the use of genetics and new technologies, and a new leader in Consumer Healthcare. The programme aimed to:
| • | Drive a common approach to RD with improved capital allocation |
| • | Align and improve the capabilities and efficiency of global support functions to support new GSK |
| • | Further optimise the supply chain and product portfolio, including the divestment of non-core assets. |
| • | A strategic review of prescription dermatology is underway |
| • | Prepare Consumer Healthcare to operate as a standalone company |
Legacy programmes included the 2018 major restructuring programme, including Tesaro, which cost £1.5 billion to the end of 2021, with cash costs of £0.6 billion and non-cash costs of £0.9 billion, and has delivered annual savings of around £0.5 billion by the end of 2021 (at 2019 rates). These savings were fully re-invested to help fund targeted increases in RD and commercial support of new products. The programme is substantially complete.
Transaction-related adjustments
Transaction-related adjustments resulted in a net charge of £1,143 million (2020: £1,237 million). This included a net £1,101 million accounting charge for the re-measurement of the contingent consideration liabilities related to the acquisitions of the former Shionogi-ViiV Healthcare joint venture and the former Novartis Vaccines business and the liabilities for the Pfizer put option and Pfizer and Shionogi preferential dividends in ViiV Healthcare.
| Charge/(credit) |
2021(1) £m |
2020(1) £m |
||||||
| Contingent consideration on former Shionogi-ViiV Healthcare Joint Venture (including Shionogi preferential dividends) |
1,026 | 1,114 | ||||||
| ViiV Healthcare put options and Pfizer preferential dividends |
48 | (52 | ) | |||||
| Contingent consideration on former Novartis Vaccines business |
27 | 172 | ||||||
| Other adjustments |
42 | 3 | ||||||
|
|
|
|
|
|||||
| Total transaction-related charges |
1,143 | 1,237 | ||||||
|
|
|
|
|
|||||
| (1) | The 2021 and 2020 results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
The £1,026 million charge relating to the contingent consideration for the former Shionogi-ViiV Healthcare joint venture represented an increase in the valuation of the contingent consideration due to Shionogi, as a result of the unwind of the discount for £380 million and a charge of £646 million primarily from adjustments to sales forecasts and the settlement with Gilead as well as updated exchange rate assumptions. The £48 million charge relating to the ViiV Healthcare put option and Pfizer preferential dividends represented an increase in the valuation of the put option as a result of the settlement with Gilead, offset by lower cash and updated exchange rate assumptions.
An explanation of the accounting for the non-controlling interests in ViiV Healthcare is set out above under “Reporting framework”.
Divestments, significant legal charges and other items
Divestments and other items also included gains from a number of asset disposals, including the disposal of royalty rights on cabozantinib, disposal of the cephalosporins business, fair value gains on investments and certain other Adjusting items, including the impact of the enactment of the increase in the headline rate of UK Corporate tax as discussed in “Note 14—Taxation” to the financial statements incorporated by reference in Item 18 below. In 2021 the net loss on disposal of interests in associates was £36 million, primarily driven by a loss on disposal of the interest in the associate Innoviva Inc. A charge of £35 million (2020: £7 million) was recorded for significant legal matters arising in 2021. Significant legal cash payments were £5 million (2020: £9 million).
45
Table of Contents
Cash generation and conversion
A summary of the consolidated cash flow statement is set out below.
| 2021 £m |
2020 £m |
|||||||
| Total net cash inflow from operating activities |
7,952 | 8,441 | ||||||
| Total net cash (outflow) from investing activities |
(1,777 | ) | 2,161 | |||||
| Total net cash inflow/(outflow) from financing activities |
(7,589 | ) | (10,132 | ) | ||||
|
|
|
|
|
|||||
| (Increase)/Decrease in cash and bank overdrafts |
(1,414 | ) | 470 | |||||
|
|
|
|
|
|||||
| Cash and bank overdrafts at beginning of year |
5,262 | 4,831 | ||||||
| Exchange adjustments |
(29 | ) | (39 | ) | ||||
| Decrease in cash and bank overdrafts |
(1,414 | ) | 470 | |||||
|
|
|
|
|
|||||
| Cash and bank overdrafts at end of year |
3,819 | 5,262 | ||||||
|
|
|
|
|
|||||
| Cash and bank overdrafts at end of year comprise: |
||||||||
| Cash and cash equivalents |
4,274 | 6,292 | ||||||
| Overdrafts |
(455 | ) | (1,030 | ) | ||||
|
|
|
|
|
|||||
| 3,819 | 5,262 | |||||||
|
|
|
|
|
|||||
The net cash inflow from operating activities for the year was £7,952 million (2020: £8,441 million). The decrease primarily reflected , increased trade receivables, adverse timing of RAR, , a reduction in cash from discontinued operations including increased separation costs and reduced adjusted operating profit at AER partly offset by reduced tax payments including tax on disposals.
Reconciliation of net cash inflow from continuing operating activities to free cash inflow
A reconciliation of net cash inflow from operating activities, which is the closest equivalent IFRS measure to free cash flow, is shown below.
| 2021(1) £m |
2020(1) £m |
|||||||
| Net cash inflow from continuing operating activities |
6,277 | 6,588 | ||||||
| Purchase of property, plant and equipment |
(950 | ) | (989 | ) | ||||
| Purchase of intangible assets |
(1,704 | ) | (956 | ) | ||||
| Proceeds from sale of property, plant and equipment |
132 | 49 | ||||||
| Proceeds from sale of intangible assets |
641 | 343 | ||||||
| Net finance costs |
(758 | ) | (824 | ) | ||||
| Dividends from joint ventures and associates |
9 | 31 | ||||||
| Contingent consideration paid (reported in investing activities) |
(114 | ) | (120 | ) | ||||
| Contribution from non-controlling interests |
7 | 3 | ||||||
| Distributions to non-controlling interests |
(239 | ) | (442 | ) | ||||
|
|
|
|
|
|||||
| Free cash inflow |
3,301 | 3,683 | ||||||
|
|
|
|
|
|||||
| (1) | The 2021 and 2020 results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
Capital expenditure and financial investment
Cash payments for tangible and intangible fixed assets amounted to £2,654 million (2020: £1,945 million) and disposals realised £773 million (2020: £392 million). Cash payments to acquire equity investments amounted to £162 million (2020: £411 million), primarily relating to Vir Biotechnology, and sales of equity investments realised £202 million (2020: £3,269 million).
Free cash flow
Free cash flow is the amount of cash generated by the Group after meeting our obligations for contingent consideration, interest, tax and dividends paid to non-controlling interests, and after capital expenditure on property, plant and equipment and intangible assets.
| 2021(1) £m |
2020(1) £m |
|||||||
| Free cash inflow |
3,301 | 3,683 | ||||||
|
|
|
|
|
|||||
| (1) | The 2021 comparative results have been restated on a consistent basis from those previously published to reflect the demerger of the Consumer Healthcare business (see “Note 41 – Acquisitions and Disposals” to the financial statements incorporated by reference in Item 18 below). |
Total cash payments to Shionogi in relation to the ViiV Healthcare contingent consideration liability in the year were £826 million (2020: £858 million), of which £721 million was recognised in cash flows from operating activities and £105 million was recognised in contingent consideration paid within investing cash flows. These payments are deductible for tax purposes.
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Treasury policies
We report in Sterling and pay dividends out of Sterling cash flows. The role of Treasury is to monitor and manage the Group’s external and internal funding requirements and financial risks in support of our strategic objectives. GSK operates on a global basis, primarily through subsidiary companies, and we manage our capital to ensure that our subsidiaries are able to operate as going concerns and to optimise returns to shareholders through an appropriate balance of debt and equity. Treasury activities are governed by policies approved annually by the Board of Directors, and most recently on 12 October 2022. A Treasury Management Group (TMG) meeting, chaired by our Chief Financial Officer, takes place on a regular basis to review Treasury activities. Its members receive management information relating to these activities.
Treasury operations
The objective of GSK’s Treasury activities is to minimise the post-tax net cost of financial operations and reduce its volatility in order to benefit earnings and cash flows. GSK uses a variety of financial instruments to finance its operations and derivative financial instruments to manage market risks from these operations. Derivatives principally comprise foreign exchange forward contracts and swaps which are used to swap borrowings and liquid assets into currencies required for Group purposes, as well as interest rate swaps which are used to manage exposure to financial risks from changes in interest rates.
Derivatives are used exclusively for hedging purposes in relation to underlying business activities and not as trading or speculative instruments.
Capital management
GSK’s financial strategy, implemented through the Group’s financial architecture, supports GSK’s strategic priorities and is regularly reviewed by the Board. We manage the capital structure of the Group through an appropriate mix of debt and equity. We continue to manage our financial policies to a credit profile that particularly targets short-term credit ratings of A-1 and P-1 while maintaining single A long-term ratings consistent with those targets.
Liquidity risk management
GSK’s policy is to borrow centrally in order to meet anticipated funding requirements. Our cash flow forecasts and funding requirements are monitored by the TMG on a regular basis. Our strategy is to diversify liquidity sources using a range of facilities and to maintain broad access to financial markets.
Each day, we sweep cash to or from number of global subsidiaries to central Treasury accounts for liquidity management purposes.
Interest rate risk management
GSK’s objective is to minimise the effective net interest cost and to balance the mix of debt at fixed and floating interest rates over time. The policy on interest rate risk management limits the net amount of floating rate debt to a specific cap, reviewed and agreed no less than annually by the Board.
Foreign exchange risk management
Our objective is to minimise the exposure of overseas operating subsidiaries to transaction risk by matching local currency income with local currency costs where possible. Foreign currency transaction exposures arising on external and internal trade flows are selectively hedged. GSK’s internal trading transactions are matched centrally and we manage inter-company payment terms to reduce foreign currency risk. Where possible, we manage the cash surpluses or borrowing requirements of subsidiary companies centrally using forward contracts to hedge future repayments back into the originating currency.
In order to reduce foreign currency translation exposure, we seek to denominate borrowings in the currencies of our principal assets and cash flows. These are primarily denominated in US Dollars, Euros and Sterling.
Borrowings can be swapped into other currencies as required. Borrowings denominated in, or swapped into, foreign currencies that match investments in overseas Group assets may be treated as a hedge against the relevant assets.
Forward contracts in major currencies are also used to reduce exposure to the Group’s investment in overseas Group assets. The TMG reviews the ratio of borrowings to assets for major currencies regularly.
Commodity risk management
Our objective is to minimise income statement volatility arising from fluctuations in commodity prices, where practical and cost effective to do so. The TMG is authorised to approve the execution of certain financial derivatives to hedge commodity price exposures.
Counterparty risk management
We set global counterparty limits for each of our banking and investment counterparties based on long-term credit ratings from Moody’s and Standard and Poor’s. Usage of these limits is actively monitored and any breach of these limits would be reported to the Chief Financial Officer immediately.
In addition, relationship banks and their credit ratings are reviewed regularly so that, when changes in ratings occur, changes can be made to investment levels or to authority limits as appropriate. All banking counterparty limits are reviewed at least annually.
Critical accounting policies
The Group consolidated financial statements have been prepared in accordance with international accounting standards in conformity with the requirements of the Companies Act 2006 and the International Financial Reporting Standards (IFRS) as issued by the International Accounting Standard Board (IASB).
We are required to make estimates and assumptions that affect the amounts of assets, liabilities, revenue and expenses reported in the financial statements. Actual amounts and results could differ from those estimates.
The critical accounting policies relate to the following areas:
| • | Turnover (Note 6) |
| • | Taxation (Note 14) |
| • | Legal and other disputes (Notes 47 and 32) |
| • | Contingent liabilities (Note 35) |
| • | Pensions and other post-employment benefits (Note 31). |
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Information on the judgements and estimates made in these areas is given in “Note 3 – Critical accounting judgements and key sources of estimation uncertainty” to the financial statements incorporated by reference in Item 18 below.
Turnover
In respect of the Turnover accounting policy, our largest business is US Commercial Operations, and the US market has the most complex arrangements for rebates, discounts and allowances. The following briefly describes the nature of the arrangements in existence in our US Commercial Operations:
| • | We have arrangements with certain indirect customers whereby the customer is able to buy products from wholesalers at reduced prices. A chargeback represents the difference between the invoice price to the wholesaler and the indirect customer’s contractual discounted price. Accruals for estimating chargebacks are calculated based on the terms of each agreement, historical experience and product growth rates |
| • | Customer rebates are offered to key managed care and Group Purchasing Organisations and other direct and indirect customers. These arrangements require the customer to achieve certain performance targets relating to the value of product purchased, formulary status or pre-determined market shares relative to competitors. The accrual for customer rebates is estimated based on the specific terms in each agreement, historical experience and product growth rates |
| • | The US Medicaid programme is a state-administered programme providing assistance to certain poor and vulnerable patients. In 1990, the Medicaid Drug Rebate Program was established to reduce state and federal expenditure on prescription drugs. In 2010, the Patient Protection and Affordable Care Act became law. We participate by providing rebates to states. Accruals for Medicaid rebates are calculated based on the specific terms of the relevant regulations or the Patient Protection and Affordable Care Act |
| • | Cash discounts are offered to customers to encourage prompt payment. These are accrued for at the time of invoicing and adjusted subsequently to reflect actual experience |
| • | We record an accrual for estimated sales returns by applying historical experience of customer returns to the amounts invoiced, together with market-related information such as stock levels at wholesalers, anticipated price increases and competitor activity |
A reconciliation of gross turnover to net turnover for US Commercial Operations is as follows:
| 2022 | 2021 | 2020 | ||||||||||||||||||||||
| £m | Margin % |
£m | Margin % |
£m | Margin % |
|||||||||||||||||||
| Gross turnover |
29,814 | 100 | 24,432 | 100 | 24,570 | 100 | ||||||||||||||||||
| Market-driven segments |
(8,275 | ) | (28 | ) | (6,875 | ) | (28 | ) | (7,004 | ) | (29 | ) | ||||||||||||
| Government mandated and state programmes |
(6,218 | ) | (21 | ) | (5,134 | ) | (21 | ) | (5,710 | ) | (23 | ) | ||||||||||||
| Cash discounts |
(536 | ) | (2 | ) | (438 | ) | (2 | ) | (453 | ) | (2 | ) | ||||||||||||
| Customer returns |
(255 | ) | (1 | ) | (253 | ) | (1 | ) | (235 | ) | (1 | ) | ||||||||||||
| Prior year adjustments |
780 | 3 | 855 | 4 | 540 | 2 | ||||||||||||||||||
| Other items |
(768 | ) | (2 | ) | (673 | ) | (3 | ) | (560 | ) | (2 | ) | ||||||||||||
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| Total deductions |
(15,272 | ) | (51 | ) | (12,518 | ) | (51 | ) | (13,422 | ) | (55 | ) | ||||||||||||
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| Net turnover |
14,542 | 49 | 11,914 | 49 | 11,148 | 45 | ||||||||||||||||||
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The reconciliation has been revised to include Vaccines as part of US Commercial Operations in all years.
Market-driven segments consist primarily of managed care and Medicare plans with which we negotiate contract pricing that is honoured via rebates and chargebacks. Mandated segments consist primarily of Medicaid and federal government programmes which receive government- mandated pricing via rebates and chargebacks.
Overall sales deduction as a percentage of sales is consistent year over year with sales growth coming primarily from Trelegy and Specialty Products including ViiV. Deductions within the year were split approximately as follows: General Medicines 70%, Specialty Medicines 20% and Vaccines 10%.
At 31 December 2022, the total accrual for rebates, discounts, allowances and returns for US Commercial Operations amounted to £5,855 million (2021: £5,044 million).
A monthly process is operated to monitor inventory levels at wholesalers for any abnormal movements. This process uses gross sales volumes, prescription volumes based on third party data sources and information received from key wholesalers. The aim of this is to maintain inventories at a consistent level from year to year based on the pattern of consumption.
On this basis, US Commercial Operations inventory levels at wholesalers and in other distribution channels at 31 December 2022 were estimated to amount to approximately four weeks of turnover. This calculation uses third party information, the accuracy of which cannot be totally verified, but is believed to be sufficiently reliable for this purpose.
Legal and other disputes
In respect of the accounting policy for Legal and other disputes, the following briefly describes the process by which we determine the level of provision that is necessary.
In accordance with the requirements of IAS 37, ‘Provisions, contingent liabilities and contingent assets’, we provide for anticipated settlement costs where an outflow of resources is considered probable and a reliable estimate may be made of the likely outcome of the dispute and legal and other expenses arising from claims against the Group.
We may become involved in significant legal proceedings, in respect of which it is not possible to meaningfully assess whether the outcome will result in a probable outflow, or to quantify or reliably estimate the liability, if any, that could result from ultimate resolution of the proceedings. In these cases, appropriate disclosure about such cases would be included in the Annual Report, but no provision would be made.
This position could change over time and, therefore, there can be no assurance that any losses that result from the outcome of any legal proceedings will not exceed by a material amount the amount of the provisions reported in the Group’s financial statements.
Like many pharmaceutical companies, we are faced with various complex product liability, anti-trust and patent litigation, as well as investigations of our operations conducted by various governmental regulatory agencies. Throughout the year, the General Counsel of the Group, as head of the Group’s legal function, and the Senior Vice President and Head of Global Litigation for the Group, who is responsible for all litigation and government investigations, routinely brief the Chief Executive Officer, the Chief Financial Officer and the Board of Directors on the significant litigation pending against the Group and governmental investigations of the Group.
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These meetings, as appropriate, detail the status of significant litigation and government investigations and review matters such as the number of claims notified to us, information on potential claims not yet notified, assessment of the validity of claims, progress made in settling claims, recent settlement levels and potential reimbursement by insurers.
The meetings also include an assessment of whether or not there is sufficient information available for us to be able to make a reliable estimate of the potential outcomes of the disputes. Often, external counsel assisting us with various litigation matters and investigations will also assist in the briefing of the Board and senior management. Following these discussions, for those matters where it is possible to make a reliable estimate of the amount of a provision, if any, that may be required, the level of provision for legal and other disputes is reviewed and adjusted as appropriate. These matters are discussed further in “Note 47 – Legal proceedings” to the financial statements incorporated by reference in Item 18 below.
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| 5.B | Liquidity and capital resources |
The information set forth under the heading “Note 44 – Financial instruments and related disclosures” on pages 245 to 261 of the GSK Annual Report 2022 is incorporated herein by reference.
The information set forth under the headings “Cash generation and conversion,” “Financial position and resources” and “Treasury policies” in Item 5.A of this annual report on Form 20-F is incorporated herein by reference.
The information set forth under the heading “Note 27 – Cash and cash equivalents” on page 216 of the GSK Annual Report 2022 is incorporated herein by reference.
The Group has, in its opinion, sufficient working capital to meet its present requirements.
Liquidity sources in the short-term
The information set forth under the heading “Liquidity risk management” on page 245 of the GSK Annual Report 2022 is incorporated herein by reference.
Liquidity sources in the long-term
The information set forth under the heading “Cash generation and conversion,” in Item 5.A of this annual report on Form 20-F is incorporated herein by reference.
Material Cash Requirements
The information set forth under the headings:
| • | “Note 30 – Net debt” on pages 218 and 219; and |
| • | “Note 36 – Commitments” on page 232 |
of the GSK Annual Report 2022 is incorporated herein by reference.
Loans: At 31 December 2022 the Group had £20.1 billion of borrowings of which £3.8 billion was repayable within one year and £16.3 billion was payable after one year. Interest payable on these loans amounted to £6.3 billion of which £0.6 billion was payable within one year and £5.7 billion was payable after more than one year. Commitments in respect of loans and future interest payable on loans are disclosed before taking into account the effect of derivatives.
Intangible assets commitments: At 31 December 2022, the Group had intangible assets commitments of £10.7 billion. Of these, £0.3 billion fall due within one year and £10.4 billion fall due after more than one year. The commitments include milestone payments, which are dependent on successful clinical development or on meeting specified sales targets, and which represent the maximum that would be paid if all milestones, however unlikely, are achieved. The amounts are not risk-adjusted or discounted.
We have entered into a number of research collaborations to develop new compounds with other pharmaceutical companies. The terms of these arrangements can include upfront fees, equity investments, loans and commitments to fund specified levels of research. In addition, we will often agree to make further payments if future ‘milestones’ are achieved. As some of these agreements relate to compounds in the early stages of development, the potential obligation to make milestone payments will continue for a number of years if the compounds move successfully through the development process. Generally, the closer the product is to marketing approval, the greater the probability of success. The amounts shown above within intangible assets represent the maximum that would be paid if all milestones were achieved.
Finance Lease obligations: At 31 December 2022 the Group had £1.0 billion of finance lease obligation of which £0.2 billion was payable within one year and £0.8 billion was payable after one year.
Property, plant and equipment: At 31 December 2022 the Group had property, plant and equipment commitments of £0.7 billion of which £0.6 billion was payable within one year and £0.1 billion was payable after one year. The information set forth under the heading “Property, plant and equipment” within “Financial position and resources” in Item 5.A of this annual report on Form 20-F is incorporated herein by reference.
Purchases commitments: At 31 December 2022 the Group had £0.2 billion of purchase commitments of which £0.1 billion was payable within one year and £0.1 billion was payable after one year.
Future finance charges on leases: At 31 December 2022 the Group had £0.1 billion of future finance charges most of which was payable after one year.
Investments: At 31 December 2022 the Group had £0.1 billion of investments commitments most of which was payable after one year.
Pensions: In connection with the demerger of Consumer Healthcare, the 31 December 2020 pension scheme valuations identified cash funding or technical provisions deficits in three GSK UK Pension Schemes. Scottish limited partnerships (“SLPs”) were established to provide a funding mechanism for each of GSK’s UK defined benefit pension schemes. The SLPs together hold shares representing 7.5% of the total issued share capital of Haleon.
Each pension scheme, through its SLP interest, is entitled to receive a distribution from that SLP in an amount equal to the net proceeds of sales of Haleon shares, and to receive dividend income on Haleon shares, until it has received an aggregate amount equal to an agreed threshold (“Proceeds Threshold”). The Proceeds Thresholds total £1,080 million (as increased by notional interest on the remaining balance from time to time), and payment of this amount would fully fund the cash funding or technical provisions deficits in the three schemes shown by the 31 December 2020 valuations. Once the Proceeds Threshold has been reached the GSK-controlled General Partner of each SLP is entitled to sell the remaining Haleon shares held by the SLP and distribute the proceeds to GSK. As at 31 December 2022, £345 million remains outstanding to the UK Pension Trustees.
There was a decrease in the commitments in 2022 as a result of a reduction in outstanding loan commitments.
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| 5.C | Research and development, patents and licenses, etc. |
The information set forth under the headings:
| • | “Research and development” on pages 15 to 28; |
| • | “Pharmaceuticals and Vaccines product development pipeline” on pages 278 to 281; |
| • | “Pharmaceutical products, competition and intellectual property” on pages 282 and 283; and |
| • | “Vaccine products, competition and intellectual property” on page 284 |
of the GSK Annual Report 2022 is incorporated herein by reference.
| 5.D | Trend information |
The information set forth under the heading “Group financial review 2022” in Item 5.A of this annual report on Form 20-F is incorporated herein by reference.
| 5.E | Critical Accounting Estimates |
Not applicable.
| Item 6. | Directors, Senior Management and Employees |
| 6.A | Directors and senior management |
The information set forth under the headings:
| • | “The Board” on pages 97 to 100; and |
| • | “GSK Leadership Team (GLT)” on pages 101 to 102 |
of the GSK Annual Report 2022 is incorporated herein by reference.
| 6.B | Compensation |
The information set forth in the report on “Remuneration” on pages 132 to 164; excluding:
| • | the second paragraph under “GSK’s Remuneration policy 2022” on page 133; and |
| • | the heading and the information under the heading “How our performance measures align to our strategy” on page 135 |
of the GSK Annual Report 2022 is incorporated herein by reference.
| 6.C | Board practices |
The information set forth under the heading:
| • | “Engaging with shareholders” and “Board evolution” within the “Chair’s statement” on page 5; |
| • | “Corporate governance” on pages 96 to 131, excluding: |
| • | the first and second paragraphs within the “Chair’s governance statement” on page 104; and |
| • | the heading and the information under the heading “Section 172 statement” on pages 112 to 114; and |
| • | “Service contracts and letters of appointment” on page 150 |
of the GSK Annual Report 2022 is incorporated herein by reference.
| 6.D | Employees |
The information set forth under the headings:
| • | “Note 9 – Employee costs” on page 200; |
| • | “Note 31 – Pensions and other post-employment benefits” on pages 220 to 228; and |
| • | “Number of employees” under “Three year selected financial data” on page 277 |
of the GSK Annual Report 2022 is incorporated herein by reference.
| 6.E | Share ownership |
The information set forth under the headings:
| • | “Note 45 – Employee share schemes” on pages 262 and 263; |
| • | “2022 Total remuneration (audited)” on pages 136 to 137; |
| • | “Vesting of PSP LTI awards” on pages 141 to 142; |
| • | “2020 PSP vesting” on page 142; |
| • | “Performance of ongoing LTI awards” on page 142; |
| • | “2022 LTI awards” on page 143; and |
| • | “Directors’ interests in shares (audited)” on pages 154 to 155 |
of the GSK Annual Report 2022 is incorporated herein by reference.
| 6.F | Disclosure of a registrant’s action to recover erroneously awarded compensation |
Not applicable.
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| Item 7. | Major Shareholders and Related Party Transactions |
| 7.A | Major shareholders |
The information set forth under the headings:
| • | “Change of control and essential contracts” within “Directors’ Report” on page 130; |
| • | “Share capital and control” on pages 296 and 297; and |
| • | “Analysis of shareholdings at 31 December 2022” on page 298 |
of the GSK Annual Report 2022 is incorporated herein by reference.
| 7.B | Related party transactions |
The information set forth under the heading “Note 40 – Related party transactions” on page 236 of the GSK Annual Report 2022 is incorporated herein by reference.
The information set forth under the heading “Demerger Agreements” in Item 10.C of this annual report on Form 20-F is incorporated herein by reference.
| 7.C | Interests of experts and counsel |
Not applicable.
| Item 8. | Financial Information |
| 8.A | Consolidated Financial Statements and Other Financial Information: |
See Item 18 below.
In addition, the information set forth under the headings:
| • | “Note 47 – Legal proceedings” on pages 265 to 267; and |
| • | “Dividends” on page 298 |
of the GSK Annual Report 2022 is incorporated herein by reference.
| 8.B | Significant Changes |
The information set forth under the heading “Note 47 – Legal proceedings” on pages 265 to 267 of the GSK Annual Report 2022 is incorporated herein by reference.
| Item 9. | The Offer and Listing |
| 9.A | Offer and listing details |
The information set forth under the headings:
| • | “Market capitalisation” on page 297; and |
| • | “Nature of trading market” on page 297 |
of the GSK Annual Report 2022 is incorporated herein by reference.
The trading symbol for GSK’s Ordinary Shares of 31 1⁄4 pence each on the London Stock Exchange is GSK and the trading symbol for GSK’s ADSs on the New York Stock Exchange (the “NYSE”) is GSK.
| 9.B | Plan of distribution |
Not applicable.
| 9.C | Markets |
The information set forth under the headings:
| • | The second paragraph under “Share capital and control” on page 296; and |
| • | “Nature of trading market” on page 297 |
of the GSK Annual Report 2022 is incorporated herein by reference.
| 9.D | Selling shareholders |
Not applicable.
| 9.E | Dilution |
Not applicable.
| 9.F | Expenses of the issue |
Not applicable.
| Item 10. | Additional Information |
| 10.A | Share Capital |
Not applicable.
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| 10.B | Articles of Association of GSK plc |
The following is a summary of the principal provisions of the company’s Articles of Association (the “Articles”). Shareholders should not rely on this summary, but should instead refer to the current Articles which are filed with the Registrar of Companies in the UK and can be viewed on the company’s website. The Articles contain the fundamental provisions of the company’s constitution, and the rules for the internal management and control of the company. The company has no statement of objects in its Articles and accordingly its objects are unrestricted in accordance with the provisions of the Companies Act 2006.
(a) Voting
All resolutions put to the vote at general meetings, including electronic general meetings (see paragraph (h)), will be decided by poll. On a poll, every shareholder who is present in person or by proxy or, in the case of an electronic general meeting, who participates or is represented by proxy via an electronic platform shall have one vote for every Ordinary Share of which they are the holder. In the case of joint holders of a share, the vote of the senior who tenders a vote, whether in person or by proxy, shall be accepted to the exclusion of the votes of the other joint holders, and seniority shall be determined by the order in which the names stand on the register. Unless the Directors otherwise decide, the right to attend a general meeting and voting rights may not be exercised by a shareholder who has not paid to the company all calls and other sums then payable by them in respect of their Ordinary Shares. The right to attend a general meeting and voting rights may not be exercised by a shareholder who is subject to an order under Section 794 of the Companies Act 2006 because they have failed to provide the company with information concerning their interests in Ordinary Shares within the prescribed period, as required by Section 793 of the Companies Act 2006.
(b) Transfer of Ordinary Shares
Any shareholder may transfer their Ordinary Shares which are in certificated form by an instrument of transfer in any usual form or in any other form which the Directors may approve. Such instrument must be properly signed and stamped or certified (or otherwise shown to the satisfaction of the Directors as being exempt from stamp duty) and lodged with the company together with the relevant share certificate(s) and such other evidence as the Directors may reasonably require to show the right of the transferor to make the transfer.
Any member may transfer title to their uncertificated Ordinary Shares by means of a relevant system, such as CREST.
The transferor of a share is deemed to remain the holder until the transferee’s name is entered on the register. The Directors may decline to register any transfer of any Ordinary Share which is not fully paid.
Registration of a transfer of uncertificated Ordinary Shares may be refused in the circumstances set out in the uncertificated securities rules, and where, in the case of a transfer to joint holders, the number of joint holders to whom the uncertificated Ordinary Share is to be transferred exceeds four.
The Articles contain no other restrictions on the transfer of fully paid certificated Ordinary Shares provided:
| (i) | the instrument of transfer is duly stamped or certified or otherwise shown to the satisfaction of the Directors to be exempt from stamp duty and is accompanied by the relevant share certificate and such other evidence of the right to transfer as the Directors may reasonably require; |
| (ii) | the transfer, if to joint transferees, is in favour of not more than four transferees; |
| (iii) | the instrument of transfer is in respect of only one class of shares; and |
| (iv) | the holder of the Ordinary Shares is not subject to an order under Section 794 of the Companies Act 2006. |
Notice of refusal to register a transfer must be sent to the transferee within two months of the instrument of transfer being lodged. The Directors may decline to register a transfer of Ordinary Shares by a person holding 0.25 per cent. or more of the existing Ordinary Shares if such person is subject to an order under Section 794 Companies Act 2006, after failure to provide the company with information concerning interests in those Ordinary Shares required to be provided under Section 793 of the Companies Act 2006, unless the transfer is carried out pursuant to an arm’s length sale.
Provisions in the Articles will not apply to uncertificated Ordinary Shares to the extent that they are inconsistent with:
| (i) | the holding of Ordinary Shares in uncertificated form; |
| (ii) | the transfer of title to Ordinary Shares by means of a system such as CREST; and |
| (iii) | any provisions of the relevant regulations. |
(c) Dividends and distribution of assets on liquidation
The profits of the company which are available for distribution and permitted by law to be distributed and which the company may by ordinary resolution from time to time declare, upon the recommendation of the Directors to distribute by way of dividend, in respect of any accounting reference period shall be distributed by way of dividend among holders of Ordinary Shares.
If in their opinion the company’s financial position justifies such payments, the Directors may, as far as any applicable legislation allows, pay interim dividends on shares of any class of such amounts and in respect of such periods as they think fit. Except in so far as the rights attaching to, or the terms of issue of, any share otherwise provide, all dividends will be declared, apportioned and paid pro rata according to the amounts paid up on the shares during any portion of the period in respect of which the dividend is paid. As the company has only one class of Ordinary Shares, the holders of such Ordinary Shares will be entitled to participate in any surplus assets on a winding-up in proportion to their shareholdings.
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(d) Variation of rights and changes in capital
Subject to the provisions of any statute (including any orders, regulations or other subordinate legislation made under it) from time to time in force concerning companies in so far as it applies to the company (the “Companies Acts”), the rights attached to any class of shares may be varied with the written consent of the holders of three-quarters in nominal value of the issued shares of that class (excluding any shares of that class held as treasury shares) or with the sanction of a special resolution passed at a separate meeting of the holders of shares of that class. At every such separate meeting, the provisions of the Articles relating to general meetings shall apply, except the necessary quorum shall be at least two persons entitled to vote and holding or representing as proxy at least one-third in nominal value of the issued shares of the relevant class (excluding any shares of that class held as treasury shares) (but provided that at any adjourned meeting one holder of shares of the relevant class present in person or by proxy shall be a quorum).
If new shares are created or issued which rank equally with any other existing shares, or if the company purchases or redeems any of its own shares, the rights of existing shares will not be regarded as changed or abrogated unless the terms of the existing shares expressly say otherwise.
(e) Unclaimed dividends
All dividends or other sums payable on or in respect of any Ordinary Shares which remain unclaimed may be invested or otherwise made use of by the Directors for the benefit of the company until claimed. Unless the Directors decide otherwise, any dividend or other sums payable on or in respect of any Ordinary Shares unclaimed after a period of six years from the date when declared or became due for payment will be forfeited and revert to the company. The company may stop sending dividend cheques or warrants by post, or employ such other means of payment in respect of any Ordinary Shares, if at least two consecutive payments have remained uncashed or are returned undelivered or if one payment has remained uncashed or is returned undelivered and the company cannot establish a new address for the holder after making reasonable enquiries; however, in either case, the company must resume sending cheques or warrants or employ such other means of payment if the holder or any person entitled to the Ordinary Shares by transmission requests the resumption in writing.
(f) Untraced shareholders
The company may sell any certificated Ordinary Shares in the company after using reasonable efforts to trace the holder of, or person entitled by transmission to, the Ordinary Shares and sending a notice to the registered address or last known address of the holder or other person entitled in accordance with the requirements of the Articles and waiting for three months if the Ordinary Shares have been in issue for at least ten years and during that period at least three dividends have become payable on them and have not been claimed or satisfied and, so far as any Director is aware, the company has not received any communication from the holder of the Ordinary Shares or any person entitled to them by transmission. Upon any such sale, the company will become indebted to the former holder of the Ordinary Shares or the person entitled to them by transmission for an amount equal to the net proceeds of sale unless and until forfeited. If no valid claim for the money has been received by the company during a period of two years from the date on which the relevant shares were sold by the company, the money will be forfeited and will belong to the company.
(g) Limitations on rights of non-resident or foreign shareholders
There are no limitations imposed by the Articles on the rights of non-resident or foreign shareholders except that there is no requirement for the company to serve notices on shareholders outside the United Kingdom and the United States, if no postal address in the United States or United Kingdom has been provided to the company. The company may choose not to serve, send or supply any notice to a particular shareholder where it considers this necessary or appropriate to deal with legal, regulatory or practical problems in, or under the laws of, any territory.
(h) General meetings of shareholders
The Articles rely on the Companies Act 2006 provisions dealing with the calling of general meeting. The company is required by the Companies Act 2006 to hold an annual general meeting each year. General meetings of shareholders may be called as necessary by the Directors and must be called promptly upon receipt of a requisition from shareholders. Under the Companies Act 2006, an annual general meeting must be called by notice of at least 21 clear days. A general meeting other than an annual general meeting may be called on not less than 14 clear days’ notice provided a special resolution reducing the notice period to 14 clear days has been passed at the immediately preceding annual general meeting or a general meeting held since that annual general meeting. The Directors may determine that a general meeting shall be held as a physical meeting or in combination with an electronic platform or platforms that enables members to participate in the meeting without physically attending (an electronic general meeting).
(i) Conflicts of interest
The Directors may, subject to the provisions of the Articles, authorise any matter which would otherwise involve a Director breaching their duty under the Companies Acts to avoid conflicts of interest (each a “Conflict”). A Director seeking authorisation in respect of a Conflict shall declare to the other Directors the nature and extent of their Conflict as soon as is reasonably practicable and shall provide the other Directors with such details of the matter as are necessary to decide how to address the Conflict. The board may resolve to authorise the relevant Director in relation to any matter the subject of a Conflict, save that the relevant Director and any other Director with a similar interest shall not count towards the quorum nor vote on any resolution giving such authority, and, if the other Directors so decide, shall be excluded from any meeting of the Directors while the Conflict is under consideration.
(j) Other Conflicts of Interest
Subject to the provisions of the Companies Acts, and provided the nature and extent of a Director’s interest has been declared to the Directors, a Director may:
| (i) | be party to, or otherwise interested in, any contract with the company, or in which the company has a direct or indirect interest; |
| (ii) | hold any other office or place of profit with the company (except that of auditor) in conjunction with their office of director for such period and upon such terms, including remuneration, as the Directors may decide; |
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| (iii) | act by themselves or through a firm with which they are associated in a professional capacity for the company or any other company in which the company may be interested (otherwise than as auditor); |
| (iv) | be or become a director of, or employed by, or otherwise be interested in any holding company or subsidiary company of the company or any other company in which the company may be interested; and |
| (v) | be or become a director of any other company in which the company does not have an interest and which cannot reasonably be regarded as giving rise to a conflict of interest at the time of their appointment as director of that other company. |
No contract in which a Director is interested shall be liable to be avoided, and any Director who is so interested is not liable to account to the company or its shareholders for any benefit realised by the contract by reason of the Director holding that office or of the fiduciary relationship thereby established. However, no Director may vote on, or be counted in the quorum, in relation to any resolution of the board relating specifically to their own appointment (including remuneration) or the terms of their termination of appointment or relating to any contract in which they have an interest (subject to certain exceptions).
Subject to the Companies Acts, the company may by ordinary resolution suspend or relax to any extent the provisions relating to directors’ interests or restrictions on voting or ratify any transaction not duly authorised by reason of a contravention of such provisions.
(k) Directors’ remuneration
Each of the Directors will be paid a fee at such rate as may from time to time be determined by the Directors, but the total fees paid to all of the directors for acting as directors (excluding any amounts paid under any other provision of the Articles) shall not exceed the higher of:
| (i) | £3 million a year; and |
| (ii) | any higher amount as the company may by ordinary resolution decide. Such fees may be satisfied in cash or in shares or any other non-cash form. Any Director who devotes special attention to the business or performs any services which the Directors consider to extend beyond the ordinary services of a Director shall be entitled to receive such remuneration (whether by way of salary, commission or otherwise) as the Directors may decide. Each Director may be paid reasonable travelling, hotel and other incidental expenses they incur in attending and returning from meetings of the Directors or committees of the Directors, or general meetings of the company, or otherwise incurred in connection with the performance of their duties for the company. |
(l) Pensions and gratuities for Directors
The Directors or any committee authorised by the Directors may provide benefits by the payment of gratuities, pensions or insurance or in any other manner for any Director or former Director or their relations, connected persons or dependants, but no benefits (except those provided for by the Articles) may be granted to or in respect of a Director or former Director who has not been employed by or held an executive office or place of profit under the company or any of its subsidiary undertakings or their respective predecessors in business without the approval of an ordinary resolution of the company.
(m) Borrowing powers
Subject to the provisions of the Companies Act 2006, the Directors may exercise all the company’s powers to borrow money; to mortgage or charge all or any of the company’s undertaking, property (present and future), and uncalled capital; to issue debentures and other securities; and to give security either outright or as collateral security for any debt, liability or obligation of the company or of any third party.
(n) Retirement and removal of Directors
A Director is subject to re-election at every annual general meeting of the company. In addition to any power of removal conferred by the Companies Acts the company may by special resolution remove any Director before the expiration of their period of office. No Director is required to retire by reason of their age, nor do any special formalities apply to the appointment or re-election of any Director who is over any age limit. No shareholding qualification for Directors shall be required.
(o) Vacation of office
The office of a director shall be vacated if:
| (i) | they resign or offer to resign, and the board resolves to accept such offer; |
| (ii) | their resignation is requested by all of the other directors and all of the other directors are not less than three in number; |
| (iii) | they are or have been suffering from mental or physical ill health and the board resolves that their office be vacated; |
| (iv) | they are absent without permission of the board from meetings of the board (whether or not an alternate director appointed by them attends) for six consecutive months and the board resolves that their office is vacated; |
| (v) | they become bankrupt or compounds with their creditors generally; |
| (vi) | they are prohibited by law from being a director; or |
| (vii) | they are removed from office pursuant to the Articles or the Companies Acts. |
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(p) Share rights
Subject to any rights attached to existing shares, shares may be issued with such rights and restrictions as the company may by ordinary resolution decide, or (if there is no such resolution or so far as it does not make specific provision) as the board may decide. Such rights and restrictions shall apply as if they were set out in the Articles. Redeemable shares may be issued, subject to any rights attached to existing shares. The board may determine the terms, conditions and manner of redemption of any redeemable share so issued. Such terms and conditions shall apply to the relevant shares as if they were set out in the Articles. Subject to the articles, any resolution passed by the shareholders and other shareholders’ rights, the Board may decide how to offer, allot, grant options over or otherwise deal with any shares in the company.
| 10.C | Material contracts |
Agreements with Novartis
On April 22, 2014, GSK and Novartis AG (“Novartis”) entered into a three-part, inter-conditional transaction, which they executed, among other agreements, a share and business sale agreement relating to the vaccines business of Novartis. GSK’s shareholders approved the transaction on December 18, 2014. The transaction closed on March 2, 2015.
Under the terms of the shareholders’ agreement, Novartis had the right to require GSK to purchase its shares in the consumer healthcare joint venture. On June 1, 2018, GSK acquired 100% of the shares in GlaxoSmithKline Consumer Healthcare Holdings Limited (“GSK Consumer Healthcare”) following cancellation of Novartis’s shares under the terms of a put option implementation agreement among GSK, Novartis and GSK Consumer Healthcare, among others.
GSK continues to have obligations to pay further sales and milestone-based consideration to Novartis under the share and business sale agreement relating to the vaccines business of Novartis.
Agreement with Pfizer
On December 19, 2018, GSK, GSK Consumer Healthcare and Pfizer Inc. (“Pfizer”) entered into a Stock and Asset Purchase Agreement (the “SAPA”) pursuant to which the parties agreed to form a consumer healthcare joint venture (the “GSK/Pfizer JV”) through the acquisition by GSK Consumer Healthcare from Pfizer of Pfizer’s consumer healthcare business and the transfer by GSK to GSK Consumer Healthcare of those parts of the GSK consumer healthcare business not already part of GSK Consumer Healthcare as of the date of the SAPA (with certain limited exceptions). As consideration for the acquisition of its consumer healthcare business, Pfizer received shares in GSK Consumer Healthcare representing a 32% ownership interest in the GSK/Pfizer JV. GSK retained a controlling interest in GSK Consumer Healthcare of 68%. On July 31, 2019, the parties entered into an amendment to the SAPA, pursuant to which: (i) GSK Consumer Healthcare transferred by novation to GlaxoSmithKline Consumer Healthcare Holdings (No. 2) Limited (“GSK Consumer Healthcare (No. 2)”) all rights, title, interest, obligations duties and liabilities of GSK Consumer Healthcare under and in respect of the SAPA, (ii) the parties released GSK Consumer Healthcare from its obligations under the SAPA in exchange for GSK Consumer Healthcare (No. 2)’s assumption thereof and (iii) certain other amendments to the SAPA and other arrangements in connection with the closing of the transaction, including in relation to the delayed legal completion of the transaction in a number of jurisdictions due to regulatory constraints. The transaction closed on July 31, 2019.
Each of GSK and Pfizer gave customary and broadly reciprocal representations and warranties to each other under the SAPA. GSK and Pfizer agreed to indemnify each other and GSK Consumer Healthcare (No. 2) (as applicable) in respect of losses (other than certain losses arising from tax matters, which are subject to a specific indemnity under the SAPA) relating to: (i) certain liabilities which the parties agreed will be retained by GSK or Pfizer; (ii) any breach of their respective covenants or agreements under the SAPA or the related ancillary agreements implementing the SAPA; or (iii) any breach of their respective representations and warranties given under the SAPA or the related ancillary agreements implementing the SAPA as of the date of completion of the transaction. GSK Consumer Healthcare (No. 2) agreed to indemnify GSK and Pfizer in respect of losses (other than certain losses arising from tax matters, which are subject to a specific indemnity under the SAPA) relating to: (i) liabilities which GSK Consumer Healthcare (No. 2) agreed to assume in connection with the transaction; (ii) liabilities resulting from the conduct of GSK Consumer Healthcare’s business other than those liabilities that GSK agreed to retain in connection with the transaction; and (iii) any breach of GSK Consumer Healthcare (No.2)’s post-completion covenants or agreements under the SAPA or the related ancillary agreements implementing the SAPA.
On June 1, 2022, GSK, Pfizer, GSK Consumer Healthcare (No. 2) and Haleon plc (“Haleon”) entered into the second amendment agreement to the SAPA to implement certain amendments in connection with the demerger of the Consumer Healthcare business (the “Demerger”) and to include Haleon in the SAPA indemnity framework by way of a guarantee given by Haleon with respect to the indemnification obligations of GSK Consumer Healthcare (No. 2) under the SAPA.
Demerger Agreements
On June 1, 2022, GSK and Haleon entered into a demerger agreement (the “Demerger Agreement”) to effect the Demerger and to govern aspects of the relationship between GSK and Haleon following completion of the Demerger, including in respect of, among other things, confidentiality and certain indemnity obligations in connection with the issuance of shares by Haleon in connection with the Demerger. The Demerger Agreement contains certain customary indemnities under which GSK indemnifies Haleon in respect of liabilities, losses demands, claims, costs, taxes and damages arising, directly or indirectly, from or in consequence of certain claims. The Demerger Agreement also sets out how guarantees given by the GSK group for the benefit of companies in the Haleon group (or vice versa) will be dealt with following the Demerger. In addition, on June 1, 2022, GSK and Haleon entered into an exchange agreement with respect to the transfer by GSK of its B Ordinary Shares in GSK Consumer Healthcare to Haleon in exchange for the issuance of shares by Haleon.
On June 1, 2022 GSK, GSK Consumer Healthcare and GSK Consumer Healthcare (No. 2) entered into an asset transfer framework agreement (the “Asset Transfer Framework Agreement”), setting out the framework for the transfer of certain businesses, assets, liabilities and employees that were excluded from the original perimeter of the GSK/Pfizer JV as contemplated in the SAPA and others that were included in the original perimeter of the GSK/Pfizer JV but had not yet legally transferred or to record the transfer of other assets under the SAPA, in each case from the GSK group to the Haleon group. The Asset Transfer Framework Agreement also sets out the framework for the transfer of certain businesses, assets, liabilities and employees from the Haleon group to the GSK group.
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On June 1, 2022, GSK, Pfizer, Anacor Pharmaceuticals, Inc., Haleon, GSK Consumer Healthcare, PF Consumer Healthcare Holdings LLC and GSK Consumer Healthcare (No. 2) entered into a Separation Co-operation and Implementation Agreement (the “SCIA”). The SCIA detailed certain actions to be taken and arrangements to be implemented to effect completion of, or which otherwise related to, the Demerger. The SCIA recorded the obligations of the parties relating to such matters and contained certain terms on which relations between the parties are governed following completion of the Demerger. The parties to the SCIA agreed to co-operate to achieve completion of the Demerger and undertook to take all steps required, and to enter into (or procure the entry into of) all documents required, to effect the Demerger.
Further, on June 1, 2022, GlaxoSmithKline Services Unlimited, GlaxoSmithKline LLC, GlaxoSmithKline Consumer Healthcare (Overseas) Limited and GlaxoSmithKline Consumer Healthcare Holdings (US) LLC entered into a Transition Services Agreement, pursuant to which each group agreed to provide limited services to the other on commercial terms and on an arms’ length basis for a transitional period, effective from completion of the Demerger.
Finally, on June 1, 2022, each of GlaxoSmithKline Trading Services Limited and GlaxoSmithKline Consumer Trading Services Limited entered into two Manufacturing and Supply Agreements with the other (each a “Manufacturing and Supply Agreement”). Pursuant to each Manufacturing and Supply Agreement, the parties agreed, to the extent required, to supply the other with pharmaceutical or Consumer Healthcare products (as the case may be) from the relevant manufacturing sites owned by each group after the Demerger on commercial terms and on an arms’ length basis.
Following the completion of the Demerger on July 18, 2022, GSK does not have material obligations under these agreements to be performed on or after the date of this annual report on Form 20-F.
| 10.D | Exchange controls |
The information set forth under the heading “Exchange controls and other limitations affecting security holders” on page 296 of the GSK Annual Report 2022 is incorporated herein by reference.
| 10.E | Taxation |
The information set forth under the heading “Tax information for shareholders” on pages 299 to 301 of the GSK Annual Report 2022 is incorporated herein by reference.
| 10.F | Dividends and paying agents |
Not applicable.
| 10.G | Statement by experts |
Not applicable.
| 10.H | Documents on display |
The information set forth under the heading “Documents on display” on page 299 of the GSK Annual Report 2022 is incorporated herein by reference.
| 10.I | Subsidiary information |
Not applicable.
| 10.J | Annual Report to Security Holders |
Not applicable.
| Item 11. | Quantitative and Qualitative Disclosures About Market Risk |
The information set forth under the heading “Treasury policies” in Item 5.A of this annual report on Form 20-F is incorporated herein by reference.
The information set forth under the heading “Note 44 – Financial instruments and related disclosures” on pages 245 to 261 of the GSK Annual Report 2022 is incorporated herein by reference.
| Item 12. | Description of Securities Other than Equity Securities |
| 12.A | Debt Securities |
Not applicable.
| 12.B | Warrants and Rights |
Not applicable.
| 12.C | Other Securities |
Not applicable.
| 12.D | American Depositary Shares |
Fees and charges payable by ADR holders
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JPMorgan Chase Bank, N.A. serves as the depositary (the “Depositary”) for GSK’s American Depositary Receipt (“ADR”) program. On July 29, 2019, GSK and the Depositary amended and restated the deposit agreement and further amended the deposit agreement on March 15, 2021 (the “Deposit Agreement”) between GSK, the Depositary and owners and holders of ADRs. Pursuant to the Deposit Agreement, ADR holders may be required to pay various fees to the Depositary, and the Depositary may refuse to provide any service for which a fee is assessed until the applicable fee has been paid. In particular, the Depositary, under the terms of the Deposit Agreement, shall charge (i) a fee of $5.00 per 100 American Depositary Shares (or portion thereof) for the issuance, delivery, reduction, cancellation or surrender (as the case may be) of American Depositary Shares (“ADSs”), (ii) a fee of U.S.$0.05 or less per ADS held (A) upon which any cash distribution is made pursuant to the Deposit Agreement or (B) in the case of an elective cash/stock dividend, upon which a cash distribution or an issuance of additional ADSs is made as a result of such elective dividend, (iii) a fee for the distribution or sale of securities, such fee being in an amount equal to the fee for the execution and delivery of ADSs referred to above which would have been charged as a result of the deposit of such securities but which securities or the net cash proceeds from the sale thereof are instead distributed by the Depositary to ADR holders entitled thereto, (iv) an aggregate fee of U.S.$0.05 or less per ADS per calendar year (or portion thereof) for services performed by the Depositary in administering the ADRs (which fee may be charged on a periodic basis during each calendar year and shall be assessed against ADR holders as of the record date or record dates set by the Depositary during each calendar year and shall be payable at the sole discretion of the Depositary by billing such Holders or by deducting such charge from one or more cash dividends or other cash distributions), and (v) a fee for the reimbursement of such fees, charges and expenses as are incurred by the Depositary and/or any of its agents (including, without limitation, the agent or agents of the Depositary (the “Custodian”) and expenses incurred on behalf of ADR holders in connection with compliance with foreign exchange control regulations or any law or regulation relating to foreign investment) in connection with the servicing of the ordinary shares or other Deposited Securities, the sale of securities (including, without limitation, Deposited Securities), the delivery of Deposited Securities or otherwise in connection with the Depositary’s or its Custodian’s compliance with applicable law, rule or regulation (which fees and charges shall be assessed on a proportionate basis against ADR holders as of the record date or dates set by the Depositary and shall be payable at the sole discretion of the Depositary by billing such ADR holders or by deducting such charge from one or more cash dividends or other cash distributions).
GSK will pay other charges and out of pocket expenses of the Depositary and any agent of the Depositary (except the Custodian) as specified in written agreements from time to time between GSK and the Depositary, except (i) stock transfer or other taxes and other governmental charges (which are payable by ADR holders or persons depositing ordinary shares), (ii) SWIFT, cable, telex and facsimile transmission and delivery charges incurred at the request of persons depositing, or ADR holders delivering ordinary shares, ADRs or Deposited Securities (which are payable by such persons or ADR holders), (iii) transfer or registration fees for the registration or transfer of Deposited Securities on any applicable register in connection with the deposit or withdrawal of Deposited Securities (which are payable by persons depositing ordinary shares or ADR holders withdrawing Deposited Securities) and (iv) in connection with the conversion of foreign currency into U.S. dollars, the Depositary shall deduct out of such foreign currency the fees, expenses and other charges charged by it and/or its agent (which may be a division, branch or affiliate) so appointed in connection with such conversion. The Depositary and/or its agent may act as principal for such conversion of foreign currency. Such charges may at any time and from time to time be changed by agreement between GSK and the Depositary.
Direct and indirect payments by the Depositary
The Depositary anticipates reimbursing GSK for certain expenses incurred by GSK that are related to the establishment and maintenance of the ADR program upon such terms and conditions as GSK and the Depositary may agree from time to time. The Depositary may make available to GSK a set amount or a portion of the Depositary fees charged in respect of the ADR program or otherwise upon such terms and conditions as GSK and the Depositary may agree from time to time. In 2022 the Depositary made payments of approximately $21.20 million.
Under certain circumstances, including removal of the Depositary or termination of the ADR program by GSK, GSK is required to repay certain amounts paid to GSK and to compensate the Depositary for payments made or services provided on behalf of GSK.
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 |
The information set forth under the heading “Internal control framework” on page 125 to 126 of the GSK Annual Report 2022 is incorporated herein by reference.
US law and regulation
A number of provisions of US law and regulation apply to the company because our shares are quoted on the NYSE in the form of American Depositary Shares.
NYSE rules
In general, the NYSE rules permit the company to follow UK corporate governance practices instead of those applied in the USA, provided that we explain any significant variations. This explanation is contained in Item 16.G of this Form 20-F. NYSE rules that came into effect in 2005 require us to file annual and interim written affirmations concerning the Audit Risk Committee and our statement on significant differences in corporate governance.
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Sarbanes-Oxley Act of 2002
Following a number of corporate and accounting scandals in the USA, Congress passed the Sarbanes-Oxley Act of 2002. Sarbanes-Oxley is a wide ranging piece of legislation concerned largely with financial reporting and corporate governance.
As recommended by the Securities and Exchange Commission (the “SEC”), the company has established a Disclosure Committee. The Committee reports to the CEO, the CFO and to the Audit Risk Committee. It is chaired by the Company Secretary and the members consist of senior managers from finance, legal, corporate communications and investor relations.
External legal counsel, the external auditors and internal experts are invited to attend its meetings periodically. It has responsibility for considering the materiality of information and, on a timely basis, determining the disclosure of that information. It has responsibility for the timely filing of reports with the SEC and the formal review of the GSK Annual Report 2022 and Form 20-F. In 2022 the Committee met 28 times.
Sarbanes-Oxley requires that this annual report on Form 20-F contain a statement as to whether a member of our Audit Risk Committee (“ARC”) is an audit committee financial expert as defined by Sarbanes-Oxley. For a summary regarding the Board’s judgment on this matter, please refer to Item 16.A below and to page 98 in the biography for “Charles Bancroft” and the paragraph under “Financial Experience” under “FRC UK Corporate Governance Code” within “Corporate governance architecture” on page 109 of the GSK Annual Report 2022.
Additional disclosure requirements arise under section 302 and section 404 of Sarbanes-Oxley in respect of disclosure controls and procedures and internal control over financial reporting.
Section 302: Corporate responsibility for financial reports
Sarbanes-Oxley also introduced a requirement for the CEO and the CFO to complete formal certifications, confirming that:
| • | they have each reviewed the GSK Annual Report 2022 and Form 20-F; |
| • | based on their knowledge, the GSK Annual Report 2022 and Form 20-F contain no material misstatements or omissions; |
| • | based on their knowledge, the financial statements and other financial information fairly present, in all material respects, the financial condition, results of operations and cash flows as of the dates, and for the periods, presented in the GSK Annual Report 2022 and Form 20-F; |
| • | they are responsible for establishing and maintaining disclosure controls and procedures that ensure that material information is made known to them, and have evaluated the effectiveness of these controls and procedures as at the year-end, the results of such evaluation being contained in the GSK Annual Report 2022 and Form 20-F; |
| • | they are responsible for establishing and maintaining internal control over financial reporting that provides reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| • | they have disclosed in the GSK Annual Report 2022 and Form 20-F any changes in internal controls over financial reporting during the period covered by the GSK Annual Report 2022 and Form 20-F that have materially affected, or are reasonably likely to affect materially, the company’s internal control over financial reporting; and |
| • | they have disclosed, based on their most recent evaluation of internal control over financial reporting, to the external auditors and the ARC, all significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting which are reasonably likely to affect adversely the company’s ability to record, process, summarize and report financial information, and any fraud (regardless of materiality) involving persons that have a significant role in the company’s internal control over financial reporting. |
The Group has carried out an evaluation under the supervision and with the participation of its management, including the CEO and CFO, of the effectiveness of the design and operation of the Group’s disclosure controls and procedures as at 31 December 2022.
There are inherent limitations to the effectiveness of any system of disclosure controls and procedures, including the possibility of human error and the circumvention or overriding of the controls and procedures. Accordingly, even effective disclosure controls and procedures can only provide reasonable assurance of achieving their control objectives.
Based on the Group’s evaluation, the CEO and CFO have concluded that, as at December 31, 2022, the disclosure controls and procedures were effective to provide reasonable assurance that information required to be disclosed in the reports that the Group files and submits under the US Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported as and when required and that it is accumulated and communicated to management, including the CEO and CFO, as appropriate, to allow timely decisions regarding disclosure.
The CEO and CFO completed these certifications on March 10, 2023.
Section 404: Management’s annual report on internal control over financial reporting.
In accordance with the requirements of section 404 of Sarbanes-Oxley, the following report is provided by management in respect of the Company’s internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the US Securities Exchange Act of 1934):
| • | management is responsible for establishing and maintaining adequate internal control over financial reporting for the Group. Internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with IFRS; |
| • | management conducted an evaluation of the effectiveness of internal control over financial reporting based on the framework in Internal Control – Integrated Framework (2013 Framework) issued by the Committee of Sponsoring Organizations of the Treadway Commission; |
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| • | management has assessed the effectiveness of internal control over financial reporting, as at 31 December 2022 and has concluded that such internal control over financial reporting was effective. In addition, there have been no changes in the Group’s internal control over financial reporting during 2022 that have materially affected, or are reasonably likely to affect materially, the Group’s internal control over financial reporting; and |
| • | Deloitte LLP, which has audited the consolidated financial statements of the Group for the year ended December 31, 2022, has also assessed the effectiveness of the Group’s internal control over financial reporting under Auditing Standard No. 2201 of the Public Company Accounting Oversight Board (United States). Their audit report can be found below. |
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Item 16. |
[Reserved] |
Item 16A. |
Audit committee financial expert |
• |
in the last paragraph in the biography for “Charles Bancroft” on page 98; |
• |
in the paragraph under “Financial Experience” under “FRC UK Corporate Governance Code” within “Corporate governance architecture” on page 109; and |
• |
in the fourth paragraph under “Sarbanes-Oxley Act of 2002” within “US law and regulation” on page 304 |
Item 16.B |
Code of Ethics |
Item 16.C |
Principal Accountant Fees and Services |
16.C(a) |
Audit Fees |
16.C(b) |
Audit-Related Fees |
16.C(c) |
Tax Fees |
16.C(d) |
All Other Fees |
16.C(e) |
The information set forth under the heading “Non-audit services” on page 129 of the GSK Annual Report 2022 is incorporated herein by reference. |
16.C(f) |
Not applicable. |
Item 16.D |
Exemptions from the Listing Standards for Audit Committees |
Item 16.E |
Purchases of Equity Securities by the Issuer and Affiliated Purchasers |
Item 16.F |
Change in Registrant’s Certifying Accountant |
Item 16.G |
Corporate Governance |
1. |
the Company must satisfy the audit committee requirements of Rule 10A-3 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”); |
2. |
the Chief Executive Officer (the “CEO”) must promptly notify the NYSE in writing after any executive officer of the Company becomes aware of any non-compliance with any applicable provisions of the NYSE’s corporate governance standards; |
3. |
the Company must submit an annual affirmation to the NYSE affirming GSK’s compliance with applicable NYSE corporate governance standards, and submit interim affirmations to the NYSE notifying it of specified changes to the audit committee or a change to the status of the Company as a foreign private issuer; and |
4. |
the Company must provide a brief description of any significant differences between its corporate governance practices and those followed by US companies under the NYSE listing standards. |
Table of Contents
The table below discloses differences between GSK’s current domestic corporate governance practices, which are based on the UK Code, and the NYSE corporate governance standards, applicable to US companies.
| NYSE Corporate Governance Standards |
Description of differences between GSK’s governance practice and the NYSE Corporate Governance Standards | |||
| Director Independence (303A.01 of the NYSE Manual) | ||||
| 1. | Listed companies must have a majority of independent directors (as defined in Section 303A.02 of the NYSE Manual (see below). | GSK complies with the equivalent domestic requirements contained in the UK Corporate Governance Code (the “UK Code”), the latest version of which was issued in July 2018.
The UK Code provides that the board of directors of GSK (the “Board”) and its committees should have a combination of skills, experience and knowledge. Consideration should be given to the length of the service of the Board and membership should be regularly refreshed (Principle K). The Board should include an appropriate combination of Executive and Non-Executive Directors and, in particular, “independent” Non-Executive Directors (for the purpose of the UK Code) such that no one individual or small group of individuals can dominate the Board’s decision-making. There should be a clear division of responsibilities between the leadership of the Board and the executive leadership of GSK’s business (Principle G). At least half the Board, excluding the Chair, should comprise Non-Executive Directors determined by the Board to be independent (Provision 11). The roles of Chair and Chief Executive should not be exercised by the same individual. If, exceptionally, this is proposed by the Board, major shareholders should be consulted ahead of appointment (Provision 9).
The current Chair of the Board, Sir Jonathan Symonds, was considered independent on appointment (Provision 9).
The Board considers that Elizabeth McKee Anderson, Charles Bancroft, Dr Anne Beal, Dr Hal Dietz, Dr Jesse Goodman, Urs Rohner and Dr Vishal Sikka are independent for the purpose of the UK Code.
A majority of the Board members are independent Non-Executive Directors and, in accordance with the requirements of the UK Code, the Board has appointed one of the independent Non-Executive Directors as Senior Independent Director to provide a sounding board for the Chair and act as an intermediary for other Directors and shareholders where necessary (Provision 12). In January 2012 the Board adopted a formal written role specification for the Senior Independent Director. | ||
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| NYSE Independence Tests (303A.02 of the NYSE Manual) | ||||
| 2. |
In order to tighten the definition of “independent director” for purposes of these standards:
(a) (i) No director qualifies as “independent” unless the board of directors affirmatively determines that the director has no material relationship with the listed company (either directly or as a partner, shareholder or officer of an organization that has a relationship with the company).
(ii) In addition, in affirmatively determining the independence of any director who will serve on the compensation committee of the listed company’s board of directors, the board of directors must consider all factors specifically relevant to determining whether a director has a relationship to the listed company which is material to that director’s ability to be independent from management in connection with the duties of a compensation committee member, including, but not limited to:
(A) the source of compensation of such director, including any consulting, advisory or other compensatory fee paid by the listed company to such director; and
(B) whether such director is affiliated with the listed company, a subsidiary of the listed company or an affiliate of a subsidiary of the listed company.
(b) In addition, a director is not independent if:
(i) The director is, or has been within the last three years, an employee of the listed company, or an immediate family member is, or has been within the last three years, an executive officer, of the listed company.
(ii) The director has received, or has an immediate family member who has received, during any twelve-month period within the last three years, more than $120,000 in direct compensation from the listed company, other than director and committee fees and pension or other forms of deferred compensation for prior service (provided such compensation is not contingent in any way on continued service).
(iii) (A) The director is a current partner or employee of a firm that is the listed company’s internal or external auditor; (B) the director has an immediate family member who is a current partner of such a firm; (C) the director has an immediate family member who is a current employee of such a firm and personally works on the listed company’s audit; or (D) the director or an immediate family member was within the last three years a partner or employee of such a firm and personally worked on the listed company’s audit within that time.
(iv) The director or an immediate family member is, or has been within the last three years, employed as an executive officer of another company where any of the listed company’s present executive officers at the same time serves or served on that company’s compensation committee.
(v) The director is a current employee, or an immediate family member is a current executive officer, of a company that has made payments to, or received payments from, the listed company for property or services in an amount which, in any of the last three fiscal years, exceeds the greater of $1 million, or 2% of such other company’s consolidated gross revenues.
(For the purposes of these standards “executive officer” is defined to have the meaning specified for the term “officer” in Rule 16a-1(f) under the Securities Exchange Act of 1934, as amended, the “Exchange Act”). |
GSK complies with the corresponding domestic requirements contained in the UK Code, which sets out the principles for GSK to determine whether a director is independent.
The Board is required to identify each Non-Executive Director it considers to be independent. Circumstances which are likely to impair, or could appear to impair a non-executive director’s independence include, but are not limited to, whether a director:
(a) is or has been an employee of GSK within the last five years;
(b) has, or has had within the last three years, a material business relationship with GSK either directly or as a partner, shareholder, director or senior employee of a body that has such a relationship with GSK;
(c) has received or receives additional remuneration from GSK apart from a director’s fee, participates in GSK’s share option or a performance-related pay scheme, or is a member of GSK’s pension scheme;
(d) has close family ties with any of GSK’s advisers, directors or senior employees;
(e) holds cross-directorships or has significant links with other directors through involvement in other companies or bodies;
(f) represents a significant shareholder; or
(g) has served on the Board for more than nine years from the date of their first appointment.
Where any of these or other relevant circumstances apply, and the Board nonetheless considers that the non-executive director is independent, a clear explanation should be provided (Provision 10).
The Board considers all its Non-Executive Directors to be independent in character and judgment and has concluded that all its Non-Executive Directors are independent within the meaning of the UK Code.
The Chair satisfied the independence criteria on appointment in accordance with the UK Code (Provision 9). The Chair should not remain in post beyond nine years from the date of their first appointment to the Board. To facilitate effective succession planning and the development of a diverse board, this period can be extended for a limited time (Provision 19).
GSK complied with the UK Code requirement, and its Articles of Association, that all Directors should be subject to annual election or re-election by shareholders (Provision 18) at its Annual General Meeting in 2022 and intends to comply with this requirement at its 2023 Annual General Meeting.
The UK Code also provides that the Board should undertake a formal and rigorous annual evaluation of its own performance and that of its committees, the Chair and individual Directors (Principle L and Provision 21). Annual evaluation of the Board should consider the Board’s composition, diversity and how effectively members work together to achieve objectives. Individual evaluation should demonstrate whether each director continues to contribute effectively (Principle L). GSK has complied with this requirement. In addition, the annual evaluation of the Board should be externally facilitated at least every three years and a statement should be made as to whether an external facilitator has any other connection with GSK or individual directors and the external facilitator should be identified in the Annual Report (Provision 21). Internally facilitated evaluations were conducted in 2015, 2016, 2018 and 2021. GSK conducted an externally facilitated evaluation in 2014, 2017, 2019, 2020 and 2022.
The FRC’s Guidance on Board Effectiveness (“Guidance”) provides that all Directors should receive an induction on joining the Board and should regularly update and refresh their skills and knowledge. The Chair should ensure that new Directors receive a full, formal and tailored induction on joining the Board (Guidance, para 61, 75-76 81). The Chair should act on the results of the annual evaluation by recognising the strengths and addressing any weaknesses of the Board. Each Director should engage with this process and take appropriate action when development needs have been identified (Provision 22). |
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| Executive Sessions (303A.03 of the NYSE Manual) | Meetings | |||
| 3. | To empower non-management directors to serve as a more effective check on management, the non-management directors of each listed company must meet at regularly scheduled executive sessions without management. | GSK complies with the equivalent domestic requirements set out in the UK Code, which requires the Chair of GSK to hold meetings with the Non-Executive Directors without executives present (Provision 13). The Non-Executive Directors, led by the Senior Independent Director, also meet at least annually without the Chair present to appraise the Chair’s performance, and on other occasions as necessary (Provision 12).
The UK Code provides that the Chair should promote a culture of openness and debate by facilitating the effective contribution of all Non-Executive Directors in particular, and constructive board relations between Executive and Non-Executive Directors (Principle F). In addition, the Chair should seek regular engagement with major shareholders in order to understand their views on governance and performance against the strategy. The Chair is responsible for ensuring that the Board as a whole has a clear understanding of the view of shareholders and stakeholders (Principle D and Provision 3). The Board should also understand the views of GSK’s other key stakeholders and keep engagement mechanisms under review so that they remain effective (Provision 5). |
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| Nominating / Corporate Governance Committee (303A.04 of the NYSE Manual) |
Nominations Committee | |||
| 4. | (a) Listed companies must have a nominating/corporate governance committee composed entirely of independent directors.
(b) The nominating/corporate governance committee must have a written charter that addresses:
(i) the committee’s purpose and responsibilities – which, at minimum, must be to: identify individuals qualified to become board members, consistent with criteria approved by the board, and to select, or to recommend that the board select, the director nominees for the next annual meeting of shareholders; develop and recommend to the board a set of corporate governance guidelines applicable to the corporation; and oversee the evaluation of the board and management; and
(ii) an annual performance evaluation of the committee. |
GSK complies with the corresponding domestic requirements set out in the UK Code, which requires GSK to have a Nominations Committee that is comprised of a majority of independent Non-Executive Directors (Provision 17). In practice, GSK’s current Nominations Corporate Governance Committee is comprised entirely of independent directors within the meaning of the UK Code. The Chair of the Board should not chair the committee when it is dealing with the appointment of their successor (Provision 17).
GSK’s Nominations Corporate Governance Committee has written terms of reference in accordance with the UK Code. The terms of reference are available on GSK’s website and explain the Nominations Corporate Governance Committee’s role and the authority delegated to it by the Board (Guidance, para 63). The Nominations Corporate Governance Committee reviews the structure, size, diversity (including diversity of gender, social and ethnic backgrounds, and cognitive and personal strengths), and composition of the Board (evaluating the balance of skills, experience, independence and knowledge on the Board), leads the process for the appointment of members to the Board and the GSK Leadership Team (the “GLT”), and makes recommendations to the Board as appropriate. The Nominations Corporate Governance Committee also monitors the planning of succession for the Board and senior management (Provision 17). | ||
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The terms and conditions of appointment of the Chair and Non-Executive Directors are available for inspection (Guidance, para 96).
The UK Code requires that GSK’s Annual Report describes the work of the Nominations Committee in discharging its duties, including the process it has used in relation to appointments, its approach to succession planning and how both support developing a diverse pipeline (Provision 23). Open advertising and/or an external search consultancy should generally be used for the appointment of a chair or a non-executive director. If an external search consultancy is engaged it should be identified in the Annual Report and a statement should be made as to whether it has any other connection with GSK or individual directors (Provision 20). This section should also include a description of how the Board evaluation has been conducted, the Board’s policy on diversity and inclusion together with its objectives and linkage to GSK’s strategy, how it has been implemented and progress on achieving the objectives, and the gender balance of those in the senior management and their direct reports (Provision 23). GSK has complied with this requirement under the UK Code.
As described above, there is an annual Board evaluation exercise, which also includes evaluation of the Board’s committees and individual Directors (Principle L).
The Board is responsible for regularly reviewing its corporate governance standards and practices. The Company Secretary oversees corporate governance matters for the Group. The Company Secretary is responsible for advising the Board on all corporate governance matters (Provision 16). Domestic requirements do not mandate GSK to establish a distinct corporate governance committee. |
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| Compensation Committee (303A.05 of the NYSE Manual) | Remuneration Committee | |||
| 5. | (a) Listed companies must have a compensation committee composed entirely of independent directors. Compensation committee members must satisfy the additional independence requirements specific to compensation committee membership set forth in Section 2(a)(ii) in the Section titled “NYSE Independence Tests” above. | GSK complies with the equivalent domestic requirements set out in the UK Code, which requires GSK to have a Remuneration Committee comprising at least three independent Non-Executive Directors (Provision 32). In practice, GSK’s current Remuneration Committee is comprised entirely of independent directors within the meaning of the UK Code. | ||
| (b) The compensation committee must have a written charter that addresses:
(i) the committee’s purpose and responsibilities – which, at a minimum, must be to have direct responsibility to:
(A) review and approve corporate goals and objectives relevant to CEO compensation, evaluate the CEO’s performance in light of those goals and objectives, and, either as a committee or together with the other independent directors (as directed by the board), determine and approve the CEO’s compensation level based on this evaluation;
(B) make recommendations to the board with respect to non-CEO executive officer compensation, and incentive-compensation and equity-based plans that are subject to board approval; and
(C) prepare the disclosure required by Item 407(e)(5) of Regulation S-K under the Exchange Act;
(ii) an annual performance evaluation of the compensation committee.
(iii) The rights and responsibilities of the compensation committee set forth in Section 303A.05(c).
(c)(i) The compensation committee may, in its sole discretion, retain or obtain the advice of a compensation consultant, independent legal counsel or other adviser.
(ii) The compensation committee shall be directly responsible for the appointment, compensation and oversight of the work of any compensation consultant, independent legal counsel or other adviser retained by the compensation committee.
(iii) The listed company must provide for appropriate funding, as determined by the compensation committee, for payment of reasonable compensation to a compensation consultant, independent legal counsel or any other adviser retained by the compensation committee. |
GSK’s Remuneration Committee has written terms of reference in accordance with the UK Code, which explain the Remuneration Committee’s role and the authority delegated to it by the Board and are available on GSK’s website (Guidance, para 63). The Remuneration Committee determines the terms of service and remuneration of the Executive Directors and members of the GLT and, with the assistance of external independent advisers, it evaluates and makes recommendations to the Board on overall executive remuneration policy (the Chair and the CEO are responsible for evaluating and making recommendations to the Board on the remuneration of Non-Executive Directors within the terms of the approved remuneration policy). It should review workforce remuneration and related policies and the alignment of incentives and rewards with culture, taking these into account when setting the policy for executive director remuneration (Provision 33). Where remuneration consultants are appointed, they should be identified in the Annual Report and a statement should be made as to whether they have any other connection with GSK or individual directors (Provision 35).
The UK Code provides that the Remuneration Committee:
(a) should take care to recognise and manage conflicts of interest when receiving views from Executive Directors or senior management, or consulting the Chief Executive about its proposals (Provision 35 Guidance, para 129) and should have delegated responsibility for setting remuneration for all Executive Directors and the Chair (Provision 33);
(b) should carefully consider the pension consequences and associated costs of basic salary increases and any other changes in pensionable remuneration, or contribution rates, particularly for Directors close to retirement (Provision 38); | |||
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(iv) The compensation committee may select a compensation consultant, legal counsel or other adviser to the compensation committee only after taking into consideration, all factors relevant to that person’s independence from management, including the following:
(A) The provision of other services to the listed company by the person that employs the compensation consultant, legal counsel or other adviser;
(B) The amount of fees received from the listed company by the person that employs the compensation consultant, legal counsel or other adviser, as a percentage of the total revenue of the person that employs the compensation consultant, legal counsel or other adviser;
(C) The policies and procedures of the person that employs the compensation consultant, legal counsel or other adviser that are designed to prevent conflicts of interest; |
(c) should ensure that compensation commitments in Directors’ terms of appointment do not reward poor performance (Provision 39). Remuneration schemes should promote long-term shareholdings by Executive Directors that support alignment with long-term shareholder interests. A formal policy should be developed for post-employment shareholding requirements encompassing both unvested and vested shares (Provision 36). Remuneration schemes and policies should enable the use of discretion to override formulaic outcomes and include provisions that would enable GSK to recover and/or withhold sums or share awards specifying the circumstances in which it would be appropriate to do so (Provision 37); and
(d) when determining Executive Director remuneration policy and practices, should address the following: (i) remuneration arrangements are transparent and promote |
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(D) Any business or personal relationship of the compensation consultant, legal counsel or other adviser with a member of the compensation committee;
(E) Any stock of the listed company owned by the compensation consultant, legal counsel or other adviser; and
(F) Any business or personal relationship of the compensation consultant, legal counsel, other adviser or the person employing the adviser with an executive officer of the listed company. |
effective engagement with shareholders and the workforce; (ii) the operation and rationale of remuneration structures are easy to understand; (iii) remuneration arrangements identify and mitigate reputational and other risks from excessive rewards and behavioural risks that can arise from target-based incentive plans; (iv) the range of possible values of rewards to individual Directors and any other limits or discretions are identified and explained at the time of approving the policy; (v) the link between individual awards, the delivery of strategy and the long-term performance of GSK should be clear; and (vi) incentive schemes should drive behaviours consistent with company purpose, values and strategy (Provision 40).
The UK Code requires that remuneration of Non-Executive Directors should not include share options or other performance-related elements, but should reflect the time commitment and responsibilities of the role (Provision 34).
The UK Code requires that notice or contract periods should be one year or less (Provision 39).
As described above, there is an annual Board evaluation exercise, which also includes evaluation of the Board’s committees (Principle L). |
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| Audit Committee (303A.06 and 303A.07 of the NYSE Manual) | Audit Risk Committee | |||
| 6. | Listed companies must have an audit committee that satisfies the requirements of Rule 10A-3 under the Exchange Act. | GSK complies with equivalent domestic requirements set out in the UK Code, which require that GSK has an Audit Risk Committee that is comprised of at least three independent Non-Executive Directors (Provision 24). GSK considers all members of the Audit Risk Committee to be independent. The Board has also satisfied itself, in line with the UK Code, that at least one member of the Audit Risk Committee has recent and relevant financial experience and that the Audit Risk Committee as a whole has competence relevant to the sector in which GSK operates (Provision 24).
Under the UK Code, the main roles and responsibilities of the Audit Risk Committee include:
(a) monitoring the integrity of the financial statements of GSK and any formal announcements relating to GSK’s financial performance, reviewing significant financial reporting judgments contained in them (Provision 25);
(b) providing advice (where requested by the Board) on whether the Annual Report and accounts, taken as a whole, is fair, balanced and understandable and provides the information necessary for shareholders to assess GSK’s position and performance, business model and strategy (Provision 25);
(c) reviewing GSK’s internal financial controls and internal control and risk management systems (Provision 25);
(d) monitoring and reviewing the effectiveness of GSK’s internal audit function (Provision 25);
(e) conducting the tender process and making recommendations to the Board regarding the appointment, re-appointment and removal of the external auditor and approving the remuneration and terms of engagement of the external auditor (Provision 25);
(f) reviewing and monitoring the external auditor’s independence and objectivity and the effectiveness of the audit process, taking into consideration relevant UK professional and regulatory requirements (Provision 25); | ||
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| (g) developing and implementing policy on the engagement of external auditors to supply non-audit services, ensuring there is prior approval of non-audit services, considering the impact this may have on independence, taking into account the relevant regulations and ethical guidance regarding the provision of non-audit services by the external audit firm, and to report to the Board on any improvement or action required (Provision 25); and
(h) reporting to the Board on how it has discharged its responsibilities (Provision 25).
The Audit Risk Committee is also the means by which the Board reviews arrangements by which the staff of GSK may, in confidence, raise concerns about possible improprieties in matters of financial reporting or other matters (Provision 6).
GSK’s Audit Risk Committee meets the requirements of Rule 10A-3 in that:
• each member of the Audit Risk Committee is deemed to be “independent” in accordance with the Exchange Act and applicable NYSE and UK requirements;
• the Audit Risk Committee, amongst other things, is responsible for recommending the appointment, compensation, maintenance of independence and oversight of the work of any registered public accounting firm engaged for the purpose of preparing or issuing an audit report or performing other audit, review or attest services for GSK, and each such accounting firm must report directly to the Audit Risk Committee;
• the Audit Risk Committee has established a procedure for the receipt, retention and treatment of complaints regarding accounting, internal accounting controls or auditing matters, and for the confidential, anonymous submission by employees of concerns regarding questionable accounting or auditing matters;
• the Audit Risk Committee has the authority to engage independent counsel and other advisors as it determines necessary to carry out its duties; and
• GSK must provide appropriate funding for the Audit Risk Committee.
The Board has determined that Charles Bancroft has the appropriate qualifications and background to be an “Audit Committee Financial Expert” as defined in rules promulgated by the SEC under the Exchange Act. |
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| 7. | (a) The audit committee must have a minimum of three members. All audit committee members must satisfy the requirements for independence set out in Section 303A.02 and, in the absence of an applicable exemption, Rule 10A-3(b)(1) under the Exchange Act.
(b) The audit committee must have a written charter that addresses:
(i) the committee’s purpose – which, at minimum, must be to:
(A) assist board oversight of (1) the integrity of the listed company’s financial statements, (2) the listed company’s compliance with legal and regulatory requirements, (3) the independent auditor’s qualifications and independence, and (4) the performance of the listed company’s internal audit function and independent auditors (if the listed company does not yet have an internal audit function because it is availing itself of a transition period pursuant to Section 303A.00, the charter must provide that the committee will assist board oversight of the design and implementation of the internal audit function); and
(B) prepare disclosure required by Item 407(d)(3)(i) of Regulation S-K (regarding the audit committee’s review and discussion of financial statements and certain other audit matters with management and auditors)
(ii) an annual performance evaluation of the audit committee; and |
GSK complies with the equivalent domestic requirements set out in the UK Code, which requires that the Audit Risk Committee should be comprised of a minimum of three independent Non-Executive Directors (Provision 24).
GSK’s Audit Risk Committee has written terms of reference in accordance with the UK Code. The terms of reference are available on GSK’s website and explain the Audit Risk Committee’s role and the authority delegated to it by the Board (Guidance, para 63).
The Audit Risk Committee’s main responsibilities include monitoring and reviewing the financial reporting process, the system of internal control and risk management, overseeing the identification and management of risks, the external and internal process and for monitoring compliance with laws, regulations and ethical codes of practice, including review throughout the year of integrated assurance reports comprising business unit and associated consolidated internal audit reports. Where requested by the Board, the Audit Risk Committee should provide advice on the following areas which the directors as a whole are required to explain in the Annual Report:
• whether the annual report and accounts, taken as a whole, is fair, balanced and understandable and provides the information necessary for shareholders to assess GSK’s performance, business model and strategy (Principle M Provision 27); and
• when taking into account GSK’s position and principal risks, how the prospects of GSK have been assessed, over what period and why the period is regarded as appropriate. The Audit Risk Committee should also advise whether there is a reasonable expectation that GSK will be able to continue in operation and meet its liabilities when falling due over the said period, drawing attention to any qualifications or assumptions as necessary (Provision 31). |
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| (iii) the duties and responsibilities of the audit committee – which, at a minimum, must include those set out in Rule 10A-3(b)(2), (3), (4) and (5) of the Exchange Act as well as to:
(A) at least annually, obtain and review a report by the independent auditor describing: the firm’s internal quality-control procedures; any material issues raised by the most recent internal quality-control review, or peer review, of the firm, or by any inquiry or investigation by governmental or professional authorities, within the preceding five years, respecting one or more independent audits carried out by the firm, and any steps taken to deal with any such issues; and (to assess the auditor’s independence) all relationships between the independent auditor and the listed company;
(B) meet to review and discuss the listed company’s annual audited financial statements and quarterly financial statements with management and the independent auditor, including reviewing the listed company’s specific disclosures under “Management’s Discussion and Analysis of Financial Condition and Results of Operations”;
(C) discuss the listed company’s earnings press releases, as well as financial information and earnings guidance provided to analysts and rating agencies;
(D) discuss policies with respect to risk assessment and risk management;
(E) meet separately, periodically, with management, with internal auditors (or other personnel responsible for the internal audit function) and with independent auditors;
(F) review with the independent auditor any audit problems or difficulties and management’s response;
(G) set clear hiring policies for employees or former employees of the independent auditors; and
(H) report regularly to the board of directors.
(c) Each listed company must have an internal audit function. |
The UK Code requires that a separate section of the Annual Report should describe the work of the Audit Risk Committee in discharging its responsibilities (Provision 26).
The Annual Report should include:
• the significant issues that the committee considered in relation to the financial statements, and how these issues were addressed (Provision 26);
• an explanation of how it has assessed the effectiveness of the external audit process and the approach taken to the appointment or reappointment of the external auditor, information on the length of tenure of the current audit firm and when a tender was last conducted and advance notice of any retendering plans (Provision 26);
• in the case of the Board not accepting the Audit Risk Committee’s recommendation on the external auditor appointment, reappointment or removal, a statement from the Audit Risk Committee explaining its recommendation and the reasons why the Board has taken a different position (Provision 26); and
• if the external auditor provides non-audit services, an explanation of how auditor objectivity and independence are safeguarded (Provision 26).
Please see section 6 above for a description of the main role and responsibilities of the Audit Risk Committee.
In accordance with the UK Code (Provision 25), the Audit Risk Committee monitors and reviews the effectiveness of GSK’s internal audit function. |
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| Shareholder Approval of Equity Compensation Plans (303A.08 of the NYSE Manual) | ||||
| 8. | Shareholders must be given the opportunity to vote on all equity-compensation plans and material revisions thereto, except for employment inducement awards, certain grants, plans and amendments in the context of mergers and acquisitions, and certain specific types of plans. However, these exempt grants, plans and amendments may be made only with the approval of the listed company’s independent compensation committee or the approval of a majority of the listed company’s independent directors. Companies must also notify the Exchange in writing when they use one of these exemptions. | GSK complies with corresponding domestic requirements in the Listing Rules, which mandate that GSK must seek shareholder approval for employee share schemes and significant changes to existing schemes, save in circumstances permitted by the Listing Rules (Listing Rule 9.4). Please see section 5(c) above. | ||
| Corporate Governance Guidelines (303A.09 of the NYSE Manual) | ||||
| 9. | Listed companies must adopt and disclose corporate governance guidelines. | GSK complies with corresponding domestic requirements in the Listing Rules and the UK Code, which require that GSK includes an explanation in its Annual Report of how it complies with the principles of the UK Code and a confirmation that it complies with the UK Code’s provisions or, where it does not, provides an explanation of how and why it does not comply (Listing Rule 9.8.6). In addition, GSK is required to make certain mandatory corporate governance statements in the Directors’ Report in accordance with the FCA’s Disclosure Guidance and Transparency Rules, DGTR 7. GSK will comply with these requirements in its 2022 Annual Report. | ||
| Code of Business Conduct and Ethics (303A.10 of the NYSE Manual) | Code of Conduct | |||
| 10. | Listed companies must adopt and disclose a code of business conduct and ethics for directors, officers and employees, and promptly disclose any waivers of the code for directors or executive officers. | GSK’s Code of Conduct for all employees, including the CEO, CFO and other senior financial officers, is available on GSK’s website. | ||
| Foreign Private Issuer Disclosure (303A.11 of the NYSE Manual) | ||||
| 11. | Listed foreign private issuers must disclose any significant ways in which their corporate governance practices differ from those followed by domestic companies under NYSE listing standards.
Listed foreign private issuers are required to provide this disclosure in the English language and in their annual reports filed on Form 20-F. |
GSK fulfils this requirement by publishing this disclosure in its Annual Report on Form 20-F.
GSK fulfils this requirement by including this disclosure in its Annual Report on Form 20-F. | ||
| Certification Requirements (303A.12 of the NYSE Manual) | ||||
| 12. | Each listed company and its CEO must file certain annual and interim certifications regarding compliance with the corporate governance requirements and certain other matters (although foreign private issuers are only required to comply with a subset of these requirements). | GSK fulfils this requirement by filing the required certifications each year. | ||
| Related Party Transactions (314.00 of the NYSE Manual) | ||||
| 13. | A listed company’s audit committee, or another independent body of the board of directors, shall conduct a reasonable prior review and oversight of all related party transactions for potential conflicts of interest and will prohibit such a transaction if it determines it to be inconsistent with the interests of the company and its shareholders. In the case of foreign private issuers, the term “related party transactions” refers to transactions required to be disclosed pursuant to Form 20-F, Item 7.B. | GSK fulfils this requirement in respect of Directors and Officers via the Nominations Corporate Governance Committee.
In respect of any material transactions with other related parties (as set out in 314.00 of the NYSE Manual), the independent Directors of the Board (excluding the Executive Directors) fulfil this requirement. The Company’s Policy on Grant of Authority for Transactions reflects the requirement for the Board’s prior review and oversight in this regard. | ||
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| Item 16.H | Mine Safety Disclosure |
Not applicable.
| Item 16.I | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. |
Not applicable.
PART III
| Item 17 | Financial Statements |
Not applicable.
| Item 18 | Financial Statements |
The information set forth under the headings:
| • | “Consolidated income statement” on page 182; |
| • | “Consolidated statement of comprehensive income” on page 182; |
| • | “Consolidated balance sheet” on page 183; |
| • | “Consolidated statement of changes in equity” on page 184; |
| • | “Consolidated cash flow statement” on page 185; and |
| • | “Notes to the financial statements” on pages 186 to 267 |
of the GSK Annual Report 2022 is incorporated herein by reference.
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the shareholders and the Board of Directors of GSK plc
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of GSK plc and subsidiaries (the “Group”) as at 31 December 2022 and 2021, the related consolidated income statements, statements of comprehensive income, statements of changes in equity, and cash flow statements, for each of the three years in the period ended 31 December 2022, and the related notes, included in Exhibit 15.2 on pages 182 to 267 (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Group as at 31 December 2022 and 2021, and the results of its operations and its cash flows for each of the three years in the period ended 31 December 2022, in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Group’s internal control over financial reporting as at 31 December 2022, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated 10 March 2022, expressed an unqualified opinion on the Group’s internal control over financial reporting.
Basis for Opinion
These financial statements are the responsibility of the Group’s management. Our responsibility is to express an opinion on the Group’s financial statements based on our audits. We are a public accounting firm registered with the 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 audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the 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 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 financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current-period audit of the financial statements that were communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the 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.
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Valuation of the ViiV Healthcare Shionogi contingent consideration liability
Accounts impacted: Contingent consideration liabilities and Other operating expense
Refer to Notes 29, 33 and 44 to the financial statements
Critical Audit Matter Description
The Group has completed a number of significant transactions which resulted in the recognition of material contingent consideration liabilities, which are a key source of estimation uncertainty. The most significant of these liabilities was the ViiV Healthcare Shionogi Contingent Consideration Liability (ViiV CCL).
The Group completed the acquisition of the remaining 50% interest in the Shionogi-ViiV Healthcare joint venture in 2012. Upon completion, the Group recognised a contingent consideration liability for the fair value of the expected future payments to be made to Shionogi. As at 31 December 2022 the liability was valued at £5,890 million.
We identified the ViiV CCL as a critical audit matter because of the significant estimates and assumptions relating to the sales forecasts used in valuing the ViiV CCL and the sensitivity of the valuation to these inputs. The most significant of these relate to sales forecasts in the United States (US) on certain products in the treatment portfolio. Such forecasts are based on an assessment of the expected launch dates, the ability to shift market practice and prescriber behaviour towards long-acting injectable treatments and 2-drug regimens, the impact of healthcare reform and subsequent sales volumes and pricing. There is incremental challenge in forecasting sales associated with recently launched products due to the lack of historical actual data. The forecasts also required significant audit effort to perform appropriate audit procedures to challenge and evaluate the reasonableness of those forecasts.
How the Critical Audit Matter Was Addressed in the Audit
We performed the following audit procedures, amongst others, related to the sales forecasts:
| • | Obtained the Group’s assessment of the key inputs and assumptions used in the forecasts and challenged the reasonableness of these, including through enquiries of key individuals from the senior leadership team, commercial strategy team and key personnel involved in the budgeting and forecasting process, and inspection of supporting evidence; |
| • | Challenged the US volume assumptions made by the Group to estimate sales forecasts. This involved benchmarking forecast market share data against external data, such as total prescription volumes and new patient prescription volumes, in order to assess for any sources of contradictory evidence; |
| • | Challenged the reasonableness of US pricing assumptions by the Group, by comparing the forecasted Returns and Rebates rate by product against the current rate, and assessing the forecasted Returns and Rebates against comparable products considering expected changes in payer policy and healthcare reform implications; |
| • | Considered the results of clinical studies undertaken in the year by the Group and key competitors in order to assess whether these are corroborative or contradictory to assumptions used in the product portfolio sales forecasts in the US; |
| • | Benchmarked the Group’s sales forecasts against those included in reports from nine analysts and considered sales forecasts on both a total ViiV basis and an individual product basis, assessing against identified contradictory data; and |
| • | Tested the controls over the key inputs and assumptions used in the valuation of the contingent consideration liability, including review controls over the sales forecasts of the treatment product portfolio used to value the ViiV CCL. |
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Valuation of US Returns and Rebates (RAR) accruals
Accounts impacted: Turnover and Trade and other payables
Refer to Note 29 to the financial statements
Critical Audit Matter Description
In the US the Group sells to customers under various commercial and government mandated contracts and reimbursement arrangements that include rebates, chargebacks and a right of return for certain pharmaceutical products. As such, revenue recognition reflects gross-to-net sales adjustments. These adjustments are known as the Returns and Rebates (RAR) accruals and are a source of significant estimation uncertainty which could have a material impact on reported revenue.
In the US Pharmaceuticals business in 2022 $18,928 million of RAR deductions were made to gross revenue of $36,953 million, resulting in net revenue of $18,023 million. The balance sheet accrual at 31 December 2022 for the combined US Pharmaceuticals and Vaccines businesses amounted to $6,881 million.
The four most significant payer channels (also referred to as buying groups) to which the RAR accrual relates are managed healthcare organisations, Medicaid, Ryan White and Medicare Part D.
The two main causes of significant estimation uncertainty are:
| • | The utilisation rate, which is the portion of total sales that will be made into each payer channel, estimated by the Group in recording the accruals. The utilisation assumption is the most challenging of the key assumptions used to derive the accrual given that it is influenced by market demand and other factors outside the control of the Group; and |
| • | The time lag between the point of sale and the point at which exact rebate amounts are known to the Group upon receipt of a claim. Those payer channels with the longest time lag result in a greater accrued period, and therefore, a greater level of estimation uncertainty in estimating the period end accrual. |
The level of estimation uncertainty is also impacted by significant shifts in channel mix driven by changes in the competitive landscape, including competitor and generic product launches and other macroeconomic factors. As such, we focus on the utilisation assumptions for those products where we deem the level of estimation uncertainty to be the most significant.
Furthermore, auditing standards presume that a significant fraud risk exists in revenue recognition. In line with this presumption, we also focus on the period-end adjustments made to the RAR accruals. These adjustments reflected updates made to the initial assumptions included within the forecasted RAR rates and, in our view, present the greatest opportunity for fraud in revenue recognition (notwithstanding the existence of internal controls).
How the Critical Audit Matter Was Addressed in the Audit
Audit procedures performed
We performed the following audit procedures, amongst others, related to estimates in the RAR accruals:
| • | Challenged assumptions for a selection of utilisation rates, focusing on certain products where we concluded the accrual is most sensitive to these assumptions. Our challenge included comparison to historical utilisation rates, consideration of historical accuracy and drivers of market changes such as the impact of competition and macroeconomic trends; |
| • | Supplemented this with substantive analytical procedures by developing an independent expectation of the accrual balance for each of the key segments, based on historical claims received adjusted to reflect market changes in the period including an assessment of the time lag between the initial point of sale and the claim receipt. We then compared this independent expectation to those recorded to evaluate the appropriateness of the year ending accrual position; |
| • | Considered the historical accuracy of estimates and evaluated whether forecast assumptions had been appropriately updated in a selection of cases where the actual rebate claims differed to the amount accrued; |
| • | Evaluated the appropriateness of, and completeness of, period-end adjustments to the liability made as part of the ongoing review of the estimated accrual; and |
| • | Tested the key controls over the estimation of RAR accruals including the controls associated with the forecasting of utilisation rates process and the month-end accrual review controls. |
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Valuation of other intangible assets
Accounts impacted: Other intangible assets, Cost of sales, Research and development, and Selling, general and administration
Refer to Notes 20 and 41 to the financial statements
Critical Audit Matter Description
As at 31 December 2022, the Group held £13,663 million of other intangible assets (including licenses, patents, trademarks, and trade names, but excluding goodwill and computer software). This includes £2,964 million of intangible assets acquired as part of business combinations with Sierra Oncology, Inc. and Affinivax Inc during the year. During 2022, impairment charges of £330 million were recorded.
An individual intangible asset, or an intangible asset which forms part of a cash-generating unit, is impaired when its carrying amount exceeds its recoverable amount. The recoverable amount of these other intangible assets relies on certain assumptions and estimates of future trading performance which create estimation uncertainty.
Future trading performance of intangible assets includes key assumptions such as sales pricing, volume, growth rates and probability of technical and regulatory success of ongoing clinical trials. This includes assumptions on timing of cash flows determined by anticipated launch year, peak year sales, subsequent sales erosion due to generic product competition and profit margin levels. In addition, due to the impact of uncertainty driven by ongoing global macroeconomic volatility, the valuation of intangible assets will also be affected by discount rate assumptions made by the Group.
We identified the valuation of other intangible assets as a critical audit matter due to the inherent judgements involved in estimating future cash flows. Auditing such assumptions and estimates required extensive audit effort to challenge and evaluate the reasonableness of forecasts and judgements.
How the Critical Audit Matter Was Addressed in the Audit
We performed the following audit procedures, amongst others, related to the future sales pricing, volume, growth rates and probability of technical and regulatory success, profit margin levels, and discount rates used in the assessment in the valuation of other intangible assets:
| • | Inquired with the key individuals from the corporate development team, commercial forecasting leads, and key personnel involved in the assets research and development process to discuss and evaluate the Group’s evidence to support the future pricing, volume, sales growth rates and probability of regulatory and technical success; |
| • | Evaluated the key inputs and assumptions applied in estimating sales and profit margin forecasts, including benchmarking of forecasts against external market data. This included independent market research of therapeutic area price points, price growth rates, and anticipated competitor market landscape, currently and at the time of forecast regulatory approval, plus assessment of any sources of contradictory evidence; |
| • | Inspected independent research and literature to consider corroborative and contradictory evidence to assess assumptions on probability of technical and regulatory success; |
| • | Compared the forecast sales and profit margin levels to the Plan data (asset by asset internal forecasts) approved by the GSK Leadership Team and the Board of Directors, where the in-development intangible asset is forecast to launch within the next 3-year period; |
| • | Assessed the historical accuracy of sales forecasts by performing retrospective reviews across marketed assets within the business; |
| • | Considered whether events or transactions that occurred after the balance sheet date but before the reporting date affect the conclusions reached on the carrying values of the assets and associated disclosures; |
| • | Engaged Internal Fair Valuation Specialists (IFVS) to assess the reasonableness of discount rates and valuation methodology; and |
| • | Tested review controls over the key inputs and assumptions used in the valuation of other intangible assets. The controls encompass review of the valuation models, which contain a number of assumptions such as the probability of technical and regulatory success, launch dates plus other revenue and cost assumptions. |
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Valuation of uncertain tax positions, including transfer pricing
Accounts impacted: Corporation tax payable, Deferred tax liabilities and Taxation charge
Refer to Note 14 to the financial statements
Critical Audit Matter Description
The Group operates in numerous jurisdictions and there are open tax and transfer pricing matters and exposures with UK, US and overseas tax authorities that give rise to uncertain tax positions. There is a wide range of possible outcomes for provisions and contingencies. Certain judgements in respect of estimates of tax exposures and contingencies are required in order to assess the adequacy of tax provisions, which are sometimes complex as a result of the considerations required over multiple tax laws and regulations.
At 31 December 2022, the Group has recorded provisions of £858 million in respect of uncertain tax positions.
How the Critical Audit Matter Was Addressed in the Audit
With the support of tax specialists, we assessed the appropriateness of the uncertain tax provisions by performing the following audit procedures amongst others:
| • | Assessed and challenged provisions for uncertain tax positions through the evaluation of possible outcomes. Our procedures were focused on those jurisdictions where the Group has the greatest potential exposure and where the highest level of judgement is required; |
| • | Assessed the assumptions and judgements that are required to determine the range of possible outcomes for recognition and measurement of uncertain tax positions in compliance with the requirements of IFRIC 23; |
| • | Involved our transfer pricing specialists to evaluate the transfer pricing methodology of the Group and associated approach to provision recognition and measurement; |
| • | Considered evidence such as the actual results from the recent tax authority audits and enquiries, third-party tax advice obtained by the Group and our tax specialists’ own knowledge of market practice in relevant jurisdictions; and |
| • | Tested key controls over preparation, review and reporting of judgmental tax balances and transactions, which include provisions for uncertain tax provisions. |
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Consumer Healthcare Demerger
Accounts impacted: Profit after taxation from discontinued operations and all balance sheet accounts
Refer to Note 41 to the financial statements
Critical Audit Matter Description
On 18 July 2022, GSK plc separated its Consumer Healthcare business from the GSK Group to form Haleon, an independent listed company. The separation was effected by way of a demerger of 80.1% of GSK’s 68% holding in the Consumer Healthcare business to GSK shareholders. GSK retained 13.5% of Haleon (7.5% are held by Scottish Limited Partnership structures (SLPs)) which are recognised as an equity investment as set out in Note 22. The Group derecognised net assets and liabilities of £12.9bn and recognised a gain on demerger of £10.1bn.
The Consumer Healthcare trading results to the demerger date have been presented as a part of discontinued operations and the comparative results have been restated on a consistent basis. At the demerger date the assets and liabilities of the Consumer business have been derecognised from the balance sheet, with the difference between the value of the net assets and the fair value of the demerged business recognised in the consolidated income statement as a gain on demerger. The cumulative exchange differences arising on translation of those Consumer Healthcare foreign currency net assets, previously included in other comprehensive income, have also been recognised in the consolidated income statement.
We identified the demerger of Consumer Healthcare as a critical audit matter because of the significant estimates related to calculating the gain on demerger and remeasuring the retained stake upon demerger, assessing the perimeters of the demerged business, validating the cumulative exchange differences arising on translation of the foreign currency net assets of the divested businesses, evaluating the Group’s tax treatment of the demerger and assessing the impact on relevant IT systems prior to the demerger. This required a high degree of auditor judgment and an increased extent of effort, including the need to involve our technical accounting, tax, and IT specialists, when performing audit procedures.
The matter is also discussed in the Audit Risk Committee report within the Corporate Governance section of the Annual Report.
How the Critical Audit Matter Was Addressed in the Audit
We performed the following audit procedures, amongst others, related to the Consumer Healthcare demerger:
| • | Consulted with technical accounting specialists to evaluate the entity’s accounting conclusions in respect of the relevant accounting standards for the demerger steps including: |
| o | the presentation of Consumer Healthcare results as a part of discontinued operations; |
| o | the calculation of the gain on demerger; and |
| o | the retained stake upon demerger. |
| • | Recalculated the gain on demerger and the fair value of the Consumer Healthcare business at the demerger date; |
| • | Tested the accuracy and completeness of the perimeters of the demerged business by inspecting legal agreements and recalculating the cumulative exchange differences arising on translation of the foreign currency net assets; |
| • | Engaged tax specialists to assess the impact of the demerger on the Group tax balances; |
| • | Engaged IT specialists to assess the impact on the relevant IT systems prior to the demerger of Consumer Healthcare; and |
| • | Tested key controls over IT and the reporting of the Consumer Healthcare Demerger including the review and approval of the accounting considerations, accuracy and completeness of transactions to the demerger date, the cumulative exchange reserve and the adjustments required in relation to the classification between continued and discontinued operations. |
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Valuation of the contingent liabilities and significant legal proceedings
Accounts impacted: Contingent liabilities and Other operating expense
Refer to Notes 35 and 47 to the financial statements
Critical Audit Matter Description
The Group operates in an environment where it is subject to significant legal and administrative proceedings, including product liability, intellectual property, tax, anti-trust, consumer fraud and governmental regulations.
The Group is currently exposed to a number of regulatory and litigation matters. In the current year, the Group classified the Zantac litigation as a significant legal matter due to the increase in cases. The Group’s provision for these matters is £218m at 31 December 2022. Other matters are disclosed as contingent liabilities where the criteria for recognising a provision under IAS 37 Provisions, Contingent Liabilities and Contingent Assets are not met.
We identified contingent liabilities and significant legal proceedings as a critical audit matter because of the significant judgement required by the Group in determining whether, under IAS 37, in particular in relation to the Zantac matter, as to:
| • | Whether the outcome will result in a probable outflow, particularly where the outcome of litigation is uncertain and subject to additional court proceedings; |
| • | The determination of a reliable estimate can be made of the amounts of the obligation; and |
The nature and extent of any contingent liabilities and underlying significant estimation uncertainties disclosed.
How the Critical Audit Matter Was Addressed in the Audit
We performed the following audit procedures:
| • | Tested the Group’s controls over the completeness of provisions, the robustness of the provision against the requirements of IAS 37, the appropriateness of judgements used to determine a ‘best estimate’ and completeness and accuracy of data used in the process; |
| • | Evaluated the assessment of the provisions, associated probabilities, and potential outcomes in accordance with IAS 37; |
| • | Evaluated the methodology, data and significant judgements and assumptions used in the valuation of the provisions are appropriate in the context of the applicable financial reporting framework; |
| • | Inquired with and inspected correspondence from the Group’s internal and external counsel to assess the litigation matter and evaluate the Group’s significant judgements and assumptions; |
| • | Where no provision was made, we critically evaluated the Group’s conclusion supportive and contradictory evidence and the requirements of IAS 37, particularly with respect to the Zantac matter; |
| • | In respect of the Zantac matter, we inspected the evidence presented in relevant scientific studies and the outcomes of other product liability litigation in the same jurisdictions alongside the entity’s assessment of possible outcomes of each ongoing and future trials; and |
| • | Evaluated whether the disclosures made in the financial statements appropriately reflect the facts and critical accounting judgements. |
Deloitte LLP
Statutory Auditor
London, United Kingdom
10 March 2023
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| Item 19 | Exhibits |
Linkbase Document
| * | Certain of the information included within Exhibit 15.2, 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 GSK Annual Report 2022 is not deemed to be filed as part of this Form 20-F. |
| ** | In accordance with Rule 402 of Regulation S-T, the information in these exhibits shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing. |
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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.
| GSK plc | ||||||
| March 10, 2023 | By: | /s/ Iain Mackay | ||||
| Iain Mackay | ||||||
| Chief Financial Officer | ||||||
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