As filed with the Securities and Exchange Commission on
March
8
, 2022 UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 20-F
| REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 |
OR
| ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year
ended December 31 , 2021
OR
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
OR
| SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Date of event requiring this shell company report
For the transition period from to
Commission file
number 1-15170
(Exact name of Registrant as specified in its charter)
(Jurisdiction of incorporation or organization)
(Address of principal executive offices)
Company Secretary
GlaxoSmithKline plc
+44 20 8047 5000
(Name, Telephone,
E-mail
and/or Facsimile number and Address of Company Contact Person) Securities registered or to be registered pursuant to Section 12(b) of the Act:
| Title of Each Class |
Trading Symbol(s) |
Name of Each Exchange On Which Registered | ||
| 2 Ordinary Shares, Par value 25 pence |
||||
Securities registered or to be registered pursuant to Section 12(g) of the Act:
None
(Title of class)
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:
None
(Title of class)
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.
Ordinary Shares of Par value 25 pence each |
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
☒ Yes ☐ No
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
☐ Yes ☒ No
Note – Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.
Indicate by check mark whether the registrant (1) has filed all reports to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
☒ Yes ☐ No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation
S-T
(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒ Yes ☐ No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a
non-accelerated
filer. See definition of “accelerated filer” and “large accelerated filer” in Rule 12b-2
of the Exchange Act: filer ☐ Non-accelerated
filer ☐ Emerging growth company If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13 (a) of the Exchange Act. ☐
† |
The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012. |
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☒
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
| U.S. GAAP ☐ |
by the International Accounting Standards Board ☒ |
Other | ☐ |
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.
Item 17 ☐ Item 18 ☐
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule
12b-2
of the Exchange Act). ☐ Yes ☒
No
TABLE OF CONTENTS
1
Pursuant to Rule 12b-23(a) of the Securities Exchange Act of 1934, as amended, the information for GlaxoSmithKline plc’s Form 20- F for the year ended December 31, 2021 as set out below is being incorporated by reference from the “GSK Annual Report 2021” included as exhibit 15.2 to this Form 20-F dated and submitted on March 8, 2022 (the “GSK Annual Report 2021”).
All references in this Form 20-F to “GlaxoSmithKline,” the “Group,” “GSK,” “we” or “our” mean GlaxoSmithKline plc and its subsidiaries; the “company” means GlaxoSmithKline 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 the inside back cover, “Directors’ Report” on page 117 , “Directors’ statement of responsibilities” on pages 154 to 155, “Share capital and control” on pages 288 to 289, “Financial calendar 2022”, “Results announcements”, “Financial reports” and “Annual General Meeting 2022” on page 291, “Registrar” on page 294, “ADS Depositary”, “Donating shares to Save the Children”, “Contacts” and “Share scam alert” on page 295, “Section 13(r) of the Securities Exchange Act” on page 297 and “Glossary of terms” on page 311 in each case of the GSK Annual Report 2021 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 2021 incorporated by reference herein, namely “Directors’ Report” (for which see page 117 thereof), the “Strategic Report” (pages 1 to 81 thereof, portions of which are incorporated by reference as described below) and the report on “Remuneration” (pages 119 to 152 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 2021 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 2021 incorporated by reference herein contain references to our website. Information on our website or any other website referenced in the GSK Annual Report 2021 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.
Recent Developments
GSK is monitoring the effects of Russia’s invasion of Ukraine. While the broader economic consequences of the invasion are currently difficult to predict, geopolitical instability, the imposition of sanctions and other restrictive measures against Russia and any retaliatory actions taken by Russia in response to such measures could adversely affect the global geopolitical and economic environment, which could in turn adversely impact GSK’s business.
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.
2
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 pharmaceutical 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, vaccine and consumer healthcare 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 46, ‘Legal proceedings’ on pages 248 to 250 of the GSK Annual Report 2021, which is incorporated by reference herein.
Patient safety
Risk definition
Potential failure to appropriately collect, review, follow up, or report human safety information (HSI), including adverse events from all potential sources, and to act on any relevant findings in a timely manner.
Risk impact
GSK has zero tolerance for an unfavourable benefit-to-risk ratio for patients who use our products. We collect, review, follow up and report human safety information from all potential sources, and use this to conduct robust and timely safety signal detection and take all appropriate measures to safeguard patients and consumers. If we do not effectively manage risks to our patient safety activities, the most serious repercussion could be harm to patients. If we are not compliant with all pharmacovigilance (or ‘drug safety’) regulations globally, consequences could include inspection findings, regulatory scrutiny, civil or criminal sanctions and either temporary or permanent loss of product marketing authorisation. Ineffective management of patient safety risks could also lead to 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, and our licence to operate depends on our compliance with increasingly complex and variable global regulatory requirements. These include not only pharmacovigilance regulations, but also stringent privacy protections and information security considerations. Our compliance depends on employees and third parties acting on our behalf managing human safety information in accordance with our internal processes.
We balance routine pharmacovigilance activities against a variety of business change initiatives. While supporting our current product portfolio, we are optimising how we perform pharmacovigilance so we are prepared to deliver our future strategy, including an increased focus on oncology, vaccines and specialty medicines and the successful separation of the Consumer Healthcare business in 2022.
We collect information on the safety and efficacy of our products in humans during clinical development and gain more comprehensive information on real-world use once our products are on the market. In addition to our own safety surveillance activities, external parties analyse publicly-available clinical trial results or other data, while new external initiatives use real-world evidence from sources which are not accessible to GSK, but may be used by regulatory agencies to supplement and validate the evidence we use to support the safety and efficacy of our products.
Extensive news and social media coverage of the safety and efficacy of COVID vaccines and therapies has increased the public’s recognition of the importance of pharmacovigilance in the drug development process and in the product marketing phase, but a rise in misinformation has also led to distrust and vaccine hesitancy. This environment could undermine regulatory, governmental, and public trust in medicines for treating COVID-19, which could negatively influence healthcare decisions for other diseases, leading to reputational damage or product liability lawsuits.
Product quality
Risk definition
Failure by GSK, its contractors or suppliers to ensure:
| • | Appropriate controls and governance of quality in product development; |
| • | Compliance with good manufacturing practice or good distribution practice regulations in commercial or clinical trials manufacture and distribution activities; |
| • | Compliance with the terms of GSK product licences and supporting regulatory activities. |
3
Risk impact
A failure to ensure product quality could have far-reaching implications for patient and consumer 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.
Context
The external environment for product quality remains challenging, affected by misinformation fuelling vaccine hesitancy, and 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 are prepared to meet the 2021 European Medicines Agency (EMA) requirements for licensing of Medical Devices and continue to prepare for the in Vitro Diagnostic Medical Device Regulation which becomes effective May 2022. We continue to plan for the implementation of the New Annex 1 guidance for the manufacture of Sterile Medicinal products in the first half of 2022.
We are increasingly using new technology to enhance the manufacture and testing of our products. For example, we use new electronic documentation systems and advanced laboratory information management tools.
Significant changes are taking place in GSK as we implement our new strategy and structure. Our quality organisations assess these changes to make sure our quality procedures and governance can facilitate the strategy, while also ensuring that no unintended consequences increase our product quality risk. The industry is experiencing an increased regulatory on-site inspection presence - resumed since the onset of the pandemic and we are taking steps to ensure our inspection readiness.
Financial controls and reporting
Risk definition
Failure to comply with current tax laws or incurring significant losses due to treasury activities; failure to report accurate financial information in compliance with accounting standards and applicable legislation.
Risk impact
Non-compliance with existing or new financial 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. In the current global pandemic, there can be significant changes at short notice. 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.
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, 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.
4
Anti-bribery and corruption (ABAC)
Risk definition
The bribery and corruption risk is the failure of GSK employees, consultants and third parties to comply with our Anti-bribery corruption (ABAC) principles and standards, as well as with all applicable legislation.
Risk impact
Failure to mitigate this risk could expose the Group and associated persons to governmental investigation, regulatory action, and civil and criminal liability and may compromise the Group’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 and might erode investor confidence in our governance and risk management. It could also lead to legal and financial penalties.
Context
The overall environment for ABAC continues to be challenging. Countries are holding individuals, as well as corporations, accountable by increasing the employer duty of care. Divergence of legislation, increasing political protectionism, social inequality and pricing pressures are making compliance harder. Society is holding corporations to ever higher standards, with technology providing a rapid and anonymous avenue for dissemination of previously confidential information and even for damaging false reports.
Enforcement actions and penalties continued across the globe with the focus on use of third-party intermediaries. Proposed EU legislation would require businesses to conduct due diligence on potential human rights and related environmental impacts of their operations and supply chains, imposing a legal standard of care. In addition, the ongoing impact of COVID-19 could increase the risk of bribery and corruption.
Supportive aspects of the external environment include an increase in transparency and collaboration among enforcement authorities with the aim of reducing bribery and corruption globally. Advances in technology and the use of data analytics are also providing better platforms to streamline processes and detect potential issues.
Commercial practices
Risk definition
Failure to engage in commercial 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 our medicines and vaccines; appropriate interactions with healthcare professionals/ organisations and patients; legitimate and transparent transfers of value; and competition (or antitrust) regulations in commercial practices, including trade channel activities and tendering business.
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 trust established with external stakeholders.
Context
We operate in a highly regulated and extremely competitive biopharma and consumer 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 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, timely, and uncertain, and carries with it the potential for failure at any stage. Even upon successful product development, we still face challenges in how we launch and how our competitors’ products or pricing strategies could render our assets less competitive. Supporting our efforts on product innovation is a continued focus on creating an omnichannel way of engagement, with a continued 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 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 by enabling people to do more, feel better, and live longer.
5
Non-promotional engagement
Risk definition
Failure to engage in non-promotional activities that are consistent with local laws, regulations and guidance, Industry Codes, internal GSK policies, standards and other controls, and GSK values, including i) communications to HCP/OHS or non-HCPs relating to our medicines and/or associated disease areas; ii) appropriate conduct of non-promotional interactions; and iii) legitimacy and transparency of non-promotional interactions.
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
Non-promotional engagements are diverse activities directed at healthcare professionals, as well as patients, payers, and external stakeholders. Such engagements are conducted to improve patient care through the exchange or provision of knowledge on the use of our products and related diseases. Non-promotional engagement with external stakeholder groups is vital to GSK, as a research-based healthcare company, and necessary for scientific and medical advances. We expect our non-promotional activities to be scientifically sound and accurate, conducted ethically and transparently, and compliant with applicable codes, laws, and regulations. However, non- promotional engagements are largely unregulated. Therefore, measured risk-taking, rooted in sound values, and principles- based decision-making, training, communication, and monitoring of such activities are key to managing the risk and enabling full and appropriate engagement.
Privacy
Risk definition
The failure to collect, secure, use, share and destroy Personal Information (PI) in accordance with data privacy laws can lead to harm to individuals (e.g. financial, stress, prejudice) and GSK (e.g. fines, operational, financial and reputational).
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 country laws also give individuals the right to bring collective legal actions against companies like GSK for failure to follow data privacy laws.
Context
Data privacy legislation is diverse with limited harmonisation or simplification. It is challenging for multinationals to standardise their approach to compliance with data privacy laws. Governments are enforcing compliance with data privacy laws more rigorously. The focus on the ethical use of personal information is growing, over and above compliance with data privacy laws, due to an increase in the volume of data processed and advances in technology.
Workforce protection and effective privacy controls for research during the COVID-19 pandemic create unique challenges.
Additionally, new data privacy laws, such as the Personal Information Protection Law (PIPL) in China, and court decisions - like the Court of Justice of the European Union ruling for Schrems II – are invalidating established international data transfer mechanisms that international companies had relied on. The increasing trend for data sovereignty affects our ability to drive medical innovation and to effectively operate internationally.
Research practices
Risk definition
Research Practices risk is the failure to adequately conduct ethical and sound pre-clinical and clinical research. In addition, it is the failure to engage in scientific activities that are consistent with the letter and spirit of the law and industry, or the Group’s requirements. It comprises the following sub-risks: Data Governance, Laboratory Research, and Human Subject Research.
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 in 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.
6
Human subject research is critical to assessing and demonstrating the safety and efficacy of our investigational products or further evaluate our products once they have been approved. This research includes clinical trials in healthy volunteers and patients and follows 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
Risk definition
Failure in management of:
| • | execution of hazardous activities; |
| • | GSK’s physical assets and infrastructure; |
| • | handling and processing of hazardous chemicals and biological agents; |
| • | control of releases of substances harmful to the environment in both the short and long-term; |
leading to incidents which could disrupt our RD and Supply activities, harm employees, harm the communities and harm the local environments in which we operate.
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.
Environmental sustainability
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. Failure to meet fast-evolving regulatory requirements and stakeholder expectations could result in litigation or regulatory actions, 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.
7
Information security
Risk definition
Risk in Information Security at GSK is characterised as the unauthorised disclosure, theft, unavailability or corruption of GSK’s Information or key information systems that may lead to 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.
Risk impact
Failure to adequately protect our information, or key information 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 overall information security environment is challenging, because of the difficulty of keeping pace with increasingly sophisticated cyber threats. This is due to many factors including, the complexity of large regulated organisations; the well-resourced nature of hacking activities; and the increasing demands for accountability of data handled by companies. Additionally, the GSK separation is a period of significant change which increases our risk and requires additional vigilance. We continue to reassess our reliance on interconnectivity with third party contractors, partners, and suppliers.
The COVID-19 pandemic continues as another significant external factor affecting how we manage information security at GSK. COVID-19-related threats include an increase in ransomware attacks against the healthcare sector, as hackers continue to use the opportunity to disrupt critical healthcare operations and, in some cases, seize healthcare research related to COVID-19 vaccines and treatments.
We operate a highly connected information network which holds 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 cyberattacks. We continue to consolidate information systems to reduce attack points and enable more focused controls. GSK’s strategic approach to digital analytics will further increase our dependency on digital assets and distributed data. Our continued analysis and assessment of our critical data assets and the threats to those assets will require a continuous re-evaluation of emerging risks to GSK. Mitigating actions identified in these areas include the secure deployment and operation of our resources in high-risk markets, the risk posed by GSK having data in the Cloud, and the potential for complexity resulting from agile business-led IT development across the enterprise.
Supply continuity
Risk definition
Failure to deliver a continuous supply of compliant finished product; inability to respond effectively to a crisis incident in a timely manner to recover and sustain critical operations.
Risk impact
We recognise how important the continuity of supply of our products is to the patients and consumers 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.
COVID-19 is an exemplar of events in the external environment which result in unforeseen, significant supply challenges, including staffing shortages for essential manufacturing operations, critical raw materials supply pressures (e.g. glass vials, plastic tubing) and interruptions in distribution.
Cybersecurity remains a significant threat to our supply chain operations. The global cyber threat has increased during the global pandemic and we remain hyper-vigilant to data security breaches and Operational Technology risks.
8
Transformation and separation
Risk definition
Failure to deliver the plan for successful transformation and separation of GSK into two new, leading companies: one BioPharma and one Consumer Healthcare.
Risk impact
The failure to manage the macro level risk due to COVID-19 and a highly competitive labour market, in relation to the delivery of the separation plan, could materially and adversely affect our ability to deliver GSK’s strategy and long-term priorities.
Context
In February 2020, GSK announced a new ‘Future Ready’ programme to prepare for its separation into two companies: new GSK, a pharma 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. As GSK increases investment in RD and new product launches, the two-year separation programme aims to drive a common approach to innovation with improved capital allocation; to align and improve the capabilities and efficiencies of global support functions to support new GSK; to further optimise the supply chain and portfolio, including divesting non-core assets; and to prepare Consumer Healthcare to operate as a standalone company. Once complete, the outlook of both companies will have been fundamentally strengthened, making them more efficient, modern, and automated, with skills and capabilities that will serve them into the future.
Risks associated with COVID-19
The potential impact of the COVID-19 pandemic on GSK’s trading performance and all our principal risks has been assessed. In 2021, as anticipated, the pandemic impacted Group performance primarily in demand for vaccines and reflected the prioritisation of COVID-19 vaccination programmes by governments, including social distancing rules resulting from COVID-19 that affected customers’ ability and willingness to access vaccination services across all regions.
This continues to be a dynamic situation, with the future severity, duration and impact unknown at this point including potential impacts on trading results, clinical trials, supply continuity and our employees. The situation could change at any time and there can be no assurance that the COVID-19 pandemic will not have a material adverse impact on the future results of the Group.
Risks relating to the demerger and separation
Completion of the demerger and separation of the Consumer Healthcare business is subject to conditions which may not be satisfied or waived
The demerger and separation of the Consumer Healthcare business to form Haleon are subject to a number of conditions, including the approval of a demerger resolution by GSK shareholders at a general meeting and the approval of a demerger dividend by the GSK Board. There can be no assurance that any or all of these conditions will be satisfied or, where relevant, waived. If any condition is not satisfied or waived, the demerger and separation will not complete.
Failure to complete the demerger and separation would result in the potential benefits of the demerger and separation not being realised and may have an adverse effect on the reputation of the Group and on the external perception of its ability to implement large-scale projects successfully. This may be the case even where the failure to implement the demerger and separation is due to factors outside the control of the Group.
In addition, if completion of the demerger and separation does not occur, the Consumer Healthcare business will remain part of the Group, which may: (i) result in a delay in the execution of the strategic objectives of the Group and the Consumer Healthcare business; (ii) have a disruptive effect on management and employees of the Group and/or the Consumer Healthcare business; or (iii) prevent the anticipated benefits and opportunities that GSK’s management believes will result from the demerger and separation from being realised. There are also costs associated with the implementation of the demerger and separation which will still be payable if the demerger and separation does not proceed.
The aggregate consequences of a failure to complete the demerger and separation could have a material impact on the business, financial condition, results of operations and/or prospects of the Group.
The Group post-demerger may fail to realise any or all of the anticipated benefits of the demerger and separation, and could fail to meet the challenges involved in operating as a standalone business
The realisation of the anticipated benefits of the demerger and separation is subject to a number of factors, including many which are outside the control of the post-demerger Group. There can be no guarantee that the anticipated benefits of the demerger and 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 demerger and separation are realised, the market price of the GSK shares may not reflect such benefits.
The post-demerger Group will face a number of challenges relating to the implementation of the demerger and separation and operating as a standalone business. There may be adverse financial, operational, regulatory, consumer, patient and reputational implications if the Group fails (either wholly or in part) to meet these challenges. Such adverse implications could impact on the ordinary course business of the Group following the demerger and, consequently, its financial condition, results of operations and/or prospects.
9
Following the demerger and separation, the post-demerger Group will form a smaller and less diversified group
Following the demerger and separation, GSK will no longer own the companies and assets that comprise the Consumer Healthcare business. Accordingly, GSK’s business will be smaller and less diversified than it is currently. 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 following the demerger and separation than would have been the case prior to the demerger and separation.
Moreover, GSK may be more susceptible to adverse developments in the remaining business and markets in which it operates. In particular, the post-demerger Group will have greater relative exposure to the global pharmaceuticals and vaccines markets and the risks associated with such markets and will no longer benefit from exposure to the consumer healthcare market.
For example, compared to the consumer healthcare business, the post-demerger Group’s businesses in global vaccines, specialty medicines and general medicines are more reliant on the complex, risky and lengthy process of RD, the success of which is in part dependant on factors beyond the Group’s control and subject to additional risks. These include disappointing results in preclinical trials for drug candidates, negative study results, clinical trials for drug candidates failing to meet trial endpoints, the need for additional studies, limitations on product scope (e.g., regional limitations, application limitations), failure to obtain adequate patent protection, competitors bringing a product to market first and regulatory approval for a product not being granted for intended use. In addition, the post-demerger Group’s business will have greater exposure to the consequences of expiry or loss of patents covering its products, including increased competition and pricing pressure.
Immediately upon completion of the demerger and separation, the post-demerger Group will continue to hold Haleon shares but cease to have any control
Following the demerger and separation, the post-demerger Group will retain up to 20% of its holding in Haleon, which it intends to monetise in a disciplined manner to strengthen the post-demerger Group’s balance sheet further. The post-demerger Group will not have the ability to control Haleon’s strategic, financial and operational decisions. Haleon may conduct its business in a manner that differs from the manner in which the post-demerger Group might have conducted the business had it retained control, may fail to develop its business or may fail to meet the expectations of investors. Haleon may also be subject to adverse publicity, increased regulatory scrutiny, or investigations by regulators or law enforcement agencies. The success of the Haleon’s business and its financial condition rely on various factors, including, among others, its ability to develop and commercialise new products effectively, negative impacts on Haleon or its brands’ reputation, its ability to compete successfully with its competitors in a highly competitive market, and changes in the regulation and perception of the ingredients it uses in its products. These factors could have an adverse effect on the reputation of Haleon which, in turn, could have an adverse effect on the reputation of the post-demerger Group. It could also have an adverse impact on the market price of Haleon shares, which may have an adverse effect on the value of the post-demerger Group’s retained investment in Haleon and the proceeds from selling this investment or any portion of it.
The post-demerger Group’s retained investment in Haleon may fall in value as a result of any decrease in the market price of Haleon shares. The price at which the post-demerger Group’s holding of Haleon shares may be quoted will be influenced by a range of factors.
Item 4. |
Information on the Company |
| 4.A | History and development of the company |
The information set forth under the heading:
| • | “About GSK” on the inside back cover; |
| • | “Head Office and Registered Office” on the outside back cover; and |
| • | “Note 40 – Acquisitions and disposals” on pages 221 to 225 |
of the GSK Annual Report 2021 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:
| • | “Our business model” on page 1 (excluding the last sentence of the third paragraph under “Delivering strategic transformation by prioritising Innovation, Performance and Trust”); |
| • | “Chair’s statement” on pages 3 and 4; |
| • | “CEO’s statement” on pages 5 and 6 (excluding (i) the first sentence of the first paragraph and the last sentence of the second paragraph under “2021 performance provides momentum” and (ii) the third paragraph under “New purpose and new ambition”, in each case, on page 5); |
| • | “Our long-term priorities” on page 10 (excluding the first bulleted paragraph under “2022 priority objectives” under “Performance”); |
| • | “Our culture” on page 11; |
| • | “Our external environment” on pages 13 to 16 (excluding the third sentence of the paragraph under “Our position” on page 13); |
| • | “Stakeholder engagement” on pages 44 and 45 (excluding the second sentence of the first paragraph on page 44); |
10
| • | “Innovation” on pages 17 to 28; |
| • | “Performance” on pages 29 to 33; |
| • | “Trust” on pages 34 to 40 (excluding the heading and the paragraph under the heading “Our approach to reporting” on page 34); |
| • | “Consumer Healthcare” on pages 41 to 43; excluding: |
| • | the seventh bulleted paragraph in the box on page 41 under “Our future standalone Consumer Healthcare business, Haleon, which is on track to separate from GSK in mid-2022, will be a new world leader focused on consumer healthcare”; and |
| • | the second sentence of the first paragraph under “2021 performance” on page 42; |
| • | “Note 6 – Turnover and segment information” on pages 180 to 183; |
| • | “Note 40 – Acquisitions and disposals” on pages 221 to 225; |
| • | “Pharmaceutical products, competition and intellectual property” on pages 272 to 273; |
| • | “Vaccines products, competition and intellectual property” on page 273; and |
| • | “Consumer Healthcare products and competition” on page 274 |
of the GSK Annual Report 2021 is incorporated herein by reference.
| 4.C | Organizational structure |
The information set forth under the headings:
| • | “Note 45 – Principal Group companies” on page 247; and |
| • | “Group companies” on pages 299 to 310 |
of the GSK Annual Report 2021 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 182; and |
| • | “Note 17 – Property, plant and equipment” on pages 193 to 194 |
of the GSK Annual Report 2021 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 headings:
| • | “Regulatory environment” on page 15; |
| • | “Climate-related financial disclosure” within Risk management on pages 49 to 52; and |
| • | “Five year record” on pages 263 to 265 (excluding the heading and the information under the heading “Financial results – Adjusted” on page 264) |
of the GSK Annual Report 2021 is incorporated herein by reference.
11
The following tables reconcile Total results to Adjusted results. References to the reconciliations on page 70 and pages 266 to 268 of the GSK Annual Report 2021 should be read to refer to the information in these tables.
Adjusted results reconciliation – 31 December 2021
| Divestments, | ||||||||||||||||||||||||||||||||
| Intangible | Intangible | significant | ||||||||||||||||||||||||||||||
| Total | asset | asset | Major | Transaction | legal and | Separation | Adjusted | |||||||||||||||||||||||||
| results | amortisation | impairment | restructuring | -related | other items | costs | results | |||||||||||||||||||||||||
| £m | £m | £m | £m | £m | £m | £m | £m | |||||||||||||||||||||||||
| Gross profit |
22,511 | 701 | (33 | ) | 154 | 28 | 27 | 23,388 | ||||||||||||||||||||||||
| Operating profit |
6,201 | 802 | 322 | 626 | 1,159 | (618 | ) | 314 | 8,806 | |||||||||||||||||||||||
| Profit before taxation |
5,442 | 802 | 322 | 628 | 1,159 | (581 | ) | 314 | 8,086 | |||||||||||||||||||||||
| Profit after taxation |
5,096 | 643 | 241 | 514 | 963 | (1,051 | ) | 265 | 6,671 | |||||||||||||||||||||||
| Profit attributable to shareholders |
4,385 | 643 | 241 | 514 | 668 | (1,051 | ) | 265 | 5,665 | |||||||||||||||||||||||
| Earnings per share |
87.6 | p | 12.9 | p | 4.8 | p | 10.3 | p | 13.3 | p | (21.0 | )p | 5.3 | p | 113.2 | p | ||||||||||||||||
| Weighted average number of shares (millions) |
5,003 | 5,003 | ||||||||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted gross profit |
|
|||||||||||||||||||||||||||||||
| Cost of sales |
(11,603 | ) | 701 | (33 | ) | 154 | 28 | 27 | (10,726 | ) | ||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted operating profit |
|
|||||||||||||||||||||||||||||||
| Selling, general and administration |
(10,975 | ) | 426 | 25 | 17 | 282 | (10,225 | ) | ||||||||||||||||||||||||
| Research and development |
(5,278 | ) | 101 | 355 | 46 | (4,776 | ) | |||||||||||||||||||||||||
| Other operating (expense)/income |
(476 | ) | 1,106 | (662 | ) | 32 | — | |||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted profit before tax |
|
|||||||||||||||||||||||||||||||
| Net finance costs |
(756 | ) | 2 | 1 | (753 | ) | ||||||||||||||||||||||||||
| Loss on disposal of interest in associates |
(36 | ) | 36 | — | ||||||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted profit after tax |
| |||||||||||||||||||||||||||||||
| Taxation |
(346 | ) | (159 | ) | (81 | ) | (114 | ) | (196 | ) | (470 | ) | (49 | ) | (1,415 | ) | ||||||||||||||||
| The following adjustments are made in arriving at Adjusted profit attributable to shareholders |
| |||||||||||||||||||||||||||||||
| Profit attributable to non-controlling interests |
711 | 295 | 1,006 | |||||||||||||||||||||||||||||
12
| Adjusted results reconciliation – 31 December 2020 |
| |||||||||||||||||||||||||||||||
| Divestments, | ||||||||||||||||||||||||||||||||
| Intangible | Intangible | significant | ||||||||||||||||||||||||||||||
| Total | asset | asset | Major | Transaction | legal and | Separation | Adjusted | |||||||||||||||||||||||||
| results | amortisation | impairment | restructuring | -related | other items | costs | results | |||||||||||||||||||||||||
| £m | £m | £m | £m | £m | £m | £m | £m | |||||||||||||||||||||||||
| Gross profit |
22,395 | 699 | 31 | 667 | 116 | 23,908 | ||||||||||||||||||||||||||
| Operating profit |
7,783 | 775 | 263 | 1,532 | 1,308 | (2,823 | ) | 68 | 8,906 | |||||||||||||||||||||||
| Profit before taxation |
6,968 | 775 | 263 | 1,534 | 1,308 | (2,821 | ) | 68 | 8,095 | |||||||||||||||||||||||
| Profit after taxation |
6,388 | 625 | 216 | 1,242 | 1,079 | (2,804 | ) | 54 | 6,800 | |||||||||||||||||||||||
| Profit attributable to shareholders |
5,749 | 625 | 216 | 1,242 | 687 | (2,804 | ) | 54 | 5,769 | |||||||||||||||||||||||
| Earnings per share |
115.5 | p | 12.6 | p | 4.4 | p | 25.0 | p | 13.8 | p | (56.5 | )p | 1.1 | p | 115.9p | |||||||||||||||||
| Weighted average number of shares (millions) |
4,976 | 4,976 | ||||||||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted gross profit |
| |||||||||||||||||||||||||||||||
| Cost of sales |
(11,704 | ) | 699 | 31 | 667 | 116 | (10,191 | ) | ||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted operating profit |
| |||||||||||||||||||||||||||||||
| Selling, general and administration |
(11,456 | ) | 1 | 18 | 659 | (23 | ) | 16 | 68 | (10,717 | ) | |||||||||||||||||||||
| Research and development |
(5,098 | ) | 75 | 214 | 206 | (4,603 | ) | |||||||||||||||||||||||||
| Other operating (expense)/income |
1,624 | 1,215 | (2,839 | ) | — | |||||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted profit before tax |
| |||||||||||||||||||||||||||||||
| Net finance costs |
(848 | ) | 2 | 2 | (844 | ) | ||||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted profit after tax |
| |||||||||||||||||||||||||||||||
| Taxation |
(580 | ) | (150 | ) | (47 | ) | (292 | ) | (229 | ) | 17 | (14 | ) | (1,295 | ) | |||||||||||||||||
| The following adjustments are made in arriving at Adjusted profit attributable to shareholders |
| |||||||||||||||||||||||||||||||
| Profit attributable to non-controlling interests |
639 | 392 | 1,031 | |||||||||||||||||||||||||||||
Adjusted results reconciliation – 31 December 2019 |
| |||||||||||||||||||||||||||
| Divestments, | ||||||||||||||||||||||||||||
| Intangible | Intangible | significant | ||||||||||||||||||||||||||
| Total | asset | asset | Major | Transaction | legal and | Adjusted | ||||||||||||||||||||||
| results | amortisation | impairment | restructuring | -related | other items | results | ||||||||||||||||||||||
| £m | £m | £m | £m | £m | £m | £m | ||||||||||||||||||||||
| Gross profit |
21,891 | 713 | 30 | 658 | 383 | 23,675 | ||||||||||||||||||||||
| Operating profit |
6,961 | 777 | 83 | 1,105 | 345 | (299 | ) | 8,972 | ||||||||||||||||||||
| Profit before taxation |
6,221 | 777 | 83 | 1,110 | 345 | (300 | ) | 8,236 | ||||||||||||||||||||
| Profit after taxation |
5,268 | 621 | 66 | 902 | 221 | (160 | ) | 6,918 | ||||||||||||||||||||
| Profit attributable to shareholders |
4,645 | 621 | 66 | 902 | 57 | (160 | ) | 6,131 | ||||||||||||||||||||
| Earnings per share |
93.9 | p | 12.6 | p | 1.3 | p | 18.2 | p | 1.2 | p | (3.3 | )p | 123.9p | |||||||||||||||
| Weighted average number of shares (millions) |
4,947 | 4,947 | ||||||||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted gross profit |
| |||||||||||||||||||||||||||
| Cost of sales |
(11,863 | ) | 713 | 30 | 658 | 383 | (10,079 | ) | ||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted operating profit |
| |||||||||||||||||||||||||||
| Selling, general and administration |
(11,402 | ) | 4 | 332 | 104 | 247 | (10,715 | ) | ||||||||||||||||||||
| Research and development |
(4,568 | ) | 64 | 49 | 114 | 2 | (4,339 | ) | ||||||||||||||||||||
| Other operating (expense)/income |
689 | 1 | (142 | ) | (548 | ) | — | |||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted profit before tax |
| |||||||||||||||||||||||||||
| Net finance costs |
(814 | ) | 5 | (1 | ) | (810 | ) | |||||||||||||||||||||
| The following adjustments are made in arriving at Adjusted profit after tax |
| |||||||||||||||||||||||||||
| Taxation |
(953 | ) | (156 | ) | (17 | ) | (208 | ) | (124 | ) | 140 | (1,318 | ) | |||||||||||||||
| The following adjustments are made in arriving at Adjusted profit attributable to shareholders |
| |||||||||||||||||||||||||||
| Profit attributable to non-controlling interests |
623 | 164 | 787 | |||||||||||||||||||||||||
13
Group financial review
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 on pages 16 and 17 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 following items 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 including the impact of the revaluation of deferred tax assets and liabilities following enactment of the increase in the headline rate of UK corporation tax from 19% to 25% (effective 2023) |
| • | separation costs include costs to establish Consumer Healthcare as an independent business, as well as admission listing and demerger costs |
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.
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 2021 and 2020 are set out above.
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.
14
Historical record of Adjusting items
The reconciliations between Total and Adjusted operating profit can be summarised as follows:
| 2021 £m |
2020 £m |
2019 £m |
||||||||||
| Total operating profit |
6,201 | 7,783 | 6,961 | |||||||||
| Intangible asset amortisation |
802 | 775 | 777 | |||||||||
| Intangible asset impairment |
322 | 263 | 83 | |||||||||
| Major restructuring |
626 | 1,532 | 1,105 | |||||||||
| Transaction-related items |
1,159 | 1,308 | 345 | |||||||||
| Divestments, significant legal and other items |
(618 | ) | (2,823 | ) | (299 | ) | ||||||
| Separation costs |
314 | 68 | — | |||||||||
| |
|
|
|
|
|
|||||||
| Adjusted operating profit |
8,806 | 8,906 | 8,972 | |||||||||
| |
|
|
|
|
|
|||||||
The analysis of the impact of transaction-related items on operating profit is as follows:
| 2021 £m |
2020 £m |
2019 £m |
||||||||||
| Contingent consideration on former Shionogi-ViiV Healthcare JV (including Shionogi preferential dividends) |
1,026 | 1,114 | 31 | |||||||||
| ViiV Healthcare put options and Pfizer preferential dividends |
48 | (52 | ) | (234 | ) | |||||||
| Contingent consideration on former Novartis Vaccines business |
27 | 172 | 76 | |||||||||
| Release of fair value uplift on acquired Pfizer inventory |
— | 91 | 366 | |||||||||
| Other adjustments |
58 | (17 | ) | 106 | ||||||||
| |
|
|
|
|
|
|||||||
| Transaction-related items |
1,159 | 1,308 | 345 | |||||||||
| |
|
|
|
|
|
|||||||
Non-controlling interests in ViiV Healthcare
Trading profit allocations
Because 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 11.7% and 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).
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.
Because 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.
15
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 |
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.
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 Sciences Inc. (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 which was received on 15 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) is 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.
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 impact of the settlement on the Pfizer put option liability is an increase of £114 million and is included in the re- measurement at 31 December 2021.
See Note 47 “Post balance sheet events” to the financial statements incorporated by reference in Item 18 below for an explanation of the post balance sheet event impact.
Free cash flow
Free cash flow is defined as the net cash inflow from 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 operations to free cash flow is set out below.
16
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.
Return on capital employed
Return on capital employed is calculated as total profit before taxation as a percentage of average net assets over the year.
Net debt
Please see Note 29 ‘Net Debt’ to the financial statements incorporated by reference in Item 18 below for the calculation of net debt. Net debt represents a measure of the capital structure of the Group.
COVID-19 solutions
COVID-19 solutions include the sales of pandemic adjuvant and other COVID-19 solutions including vaccine manufacturing and and the associated costs but does not include reinvestment in RD. This categorisation is used by management and we believe is helpful to investors through providing clarity on the results of the Group by showing the contribution to growth from COVID-19 solutions.
Xevudy
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.
17
Financial Performance
GSK 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 and other non-IFRS measures are defined above under “Reporting framework” and reconciliations of Total results to Adjusted results are set out above.
The Total results of the Group are set out below.
| 2021 | 2020 | Growth | ||||||||||||||||||||||
| % of | % of | |||||||||||||||||||||||
| £m | turnover | £m | turnover | £% | CER% | |||||||||||||||||||
| Turnover |
34,114 | 100 | 34,099 | 100 | — | 5 | ||||||||||||||||||
| Cost of sales |
(11,603 | ) | (34.0 | ) | (11,704 | ) | (34.3 | ) | (1 | ) | 2 | |||||||||||||
| Selling, general and administration |
(10,975 | ) | (32.1 | ) | (11,456 | ) | (33.6 | ) | (4 | ) | — | |||||||||||||
| Research and development |
(5,278 | ) | (15.5 | ) | (5,098 | ) | (15.0 | ) | 4 | 7 | ||||||||||||||
| Royalty income |
419 | 1.2 | 318 | 0.9 | 32 | 32 | ||||||||||||||||||
| Other operating (expense)/income |
(476 | ) | (1.4 | ) | 1,624 | 4.8 | ||||||||||||||||||
| Operating profit |
6,201 | 18.2 | 7,783 | 22.8 | (20 | ) | (9 | ) | ||||||||||||||||
| Net finance costs |
(756 | ) | (848 | ) | ||||||||||||||||||||
| Share of after-tax profits of associates and joint ventures |
33 | 33 | ||||||||||||||||||||||
| Loss on disposal of interest in associates |
(36 | ) | ||||||||||||||||||||||
| Profit before taxation |
5,442 | 6,968 | (22 | ) | (10 | ) | ||||||||||||||||||
| Taxation |
(346 | ) | (580 | ) | ||||||||||||||||||||
| Profit after taxation for the year |
5,096 | 6,388 | (20 | ) | (9 | ) | ||||||||||||||||||
| Profit attributable to shareholders |
4,385 | 5,749 | ||||||||||||||||||||||
| Earnings per share (p) |
87.6p | 115.5 | (24 | ) | (13 | ) | ||||||||||||||||||
| Earnings per ADS (US$) |
2.42 | 2.98 | ||||||||||||||||||||||
Group turnover
Group turnover by business
| 2021 £m |
2020 £m |
Growth £% |
Growth CER% |
|||||||||||||
| Pharmaceuticals |
17,729 | 17,056 | 4 | 10 | ||||||||||||
| Vaccines |
6,778 | 6,982 | (3 | ) | 2 | |||||||||||
| Consumer Healthcare |
9,607 | 10,033 | (4 | ) | — | |||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 34,114 | 34,071 | — | 5 | |||||||||||||
| Corporate and other unallocated turnover |
28 | |||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 34,114 | 34,099 | — | 5 | |||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Group turnover by geographic region
| 2021 £m |
2020 £m |
Growth £% |
Growth CER% |
|||||||||||||
| US |
15,093 | 14,556 | 4 | 10 | ||||||||||||
| Europe |
7,838 | 8,164 | (4 | ) | (2 | ) | ||||||||||
| International |
11,183 | 11,379 | (2 | ) | 4 | |||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 34,114 | 34,099 | — | 5 | |||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Group turnover by geographic region
Group turnover was £34,114 million in the year, stable at AER but up 5% CER. Sales of COVID-19 solutions contributed approximately 4 percentage points to growth in the year.
Pharmaceuticals and Vaccines Innovation sales (sales of products launched in the last five years) amounted to £6,841 million in 2021, driven by sales of . 2021 includes products that have benefited from significant lifecycle innovation.
Shingrix, Trelegy, Nucala, Benlysta, Dovato, Juluca, and Zejula
18
Pharmaceuticals turnover
| 2021 £m |
2020 (revised*) £m |
Growth £% |
Growth CER% |
|||||||||||||
| Respiratory |
2,863 | 2,360 | 21 | 28 | ||||||||||||
| HIV |
4,777 | 4,876 | (2 | ) | 3 | |||||||||||
| Immuno-inflammation |
885 | 727 | 22 | 29 | ||||||||||||
| Oncology |
489 | 372 | 31 | 37 | ||||||||||||
| Pandemic |
958 | — | — | — | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| New and Specialty |
9,972 | 8,335 | 20 | 26 | ||||||||||||
| Established Pharmaceuticals |
7,757 | 8,721 | (11 | ) | (6 | ) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 17,729 | 17,056 | 4 | 10 | |||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| * | GSK has reviewed the presentation of its pharmaceuticals products and from 1 January 2021 has moved sales of Arnuity Ellipta Incruse Ellipta Relvar/Breo Ellipta |
Pharmaceuticals turnover in the year was £17,729 million, up 4% AER, 10% CER. Sales of , the monoclonal antibody treatment for COVID-19 of £958 million contributed approximately 6 percentage points to Pharmaceuticals growth.
Xevudy
HIV sales were down 2% AER but up 3% CER, to £4,777 million, with growth in and partly offset byand . Respiratory sales were up 21% AER, 28% CER, to £2,863 million, on growth of and. Oncology and Immuno-inflammation therapy areas each continued to show strong double-digit sales growth. Sales of Established Pharmaceuticals decreased 11% AER, 6% CER to £7,757 million.
Dovato
Juluca
Tivicay
Triumeq
Trelegy
Nucala
In
the US, sales grew 13% AER, 21% CER including sales of Xevudy
Trelegy
Nucala
Benlysta
Dovato
In Europe, sales decreased 4%AER, 2% CER, with decreases
in
the Established Pharmaceuticals portfolio, impacted by generic competition including Seretide
Duodart
Volibris
Trelegy
Benlysta
Dovato
Xevudy
International sales decreased 3% AER but grew 4% CER. Decreases in Established Pharmaceuticals reflected the impact of COVID-19 suppressed antibiotics markets and increased generic competition in the first half of the year. This was offset by strong growth in Respiratory,, tenders, and sales of , which added approximately 6 percentage points to International total growth.
Dovato
Tivicay
Xevudy
Respiratory
Total Respiratory sales were up 21% AER, 28% CER, with sales of and each exceeding £1 billion per year for the first time. International Respiratory sales grew 33% AER, 42% CER including up 23% AER, 34% CER, and up 81% AER, 92% CER including the impact of the asthma launch in Japan in Q4 2020. In Europe, Respiratory grew 11% AER, 13% CER with double digit CER growth of and. In the US, Respiratory grew 23% AER, 30% CER, driven by continued strong performance of and.
Trelegy
Nucala
Nucala
Trelegy
Trelegy
Trelegy
Nucala
Trelegy
Nucala
Sales of 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.
Nucala
Trelegy
Trelegy
HIV
HIV sales were £4,777 million a decrease of 2% AER but growth of 3% CER for the year. sales were £1,882 million, down 18% AER, 14% CER and sales were £1,381 million, down 10% AER, 4% CER. The mature portfolio resulted in less than 1 percentage point of CER sales decrease.
Triumeq
Tivicay
New HIV products , , and delivered sales of £1,387 million representing 29% of the total HIV portfolio (18% in 2020). Sales of the two drug regimens and were £517 million and £787 million, respectively, with combined growth of 50% AER, 58% CER. sales were £45 million., the first long acting injectable, recorded £38 million of sales for the full year.
Juluca
Dovato
Rukobia
Cabenuva
Juluca
Dovato
Rukobia
Cabenuva
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: £428 million with growth of 87% AER, 99% CER, £393 million with growth of 2% AER, 8% CER, £43 million and £32 million. Combined and 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 £111 million with growth of 14% AER, 18% CER. Combined and 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 tender business and new HIV products.
Dovato
Juluca
Rukobia
Cabenuva
Tivicay
Triumeq
Juluca
Tivicay
Triumeq
Tivicay
Immuno-inflammation
Immuno-inflammation sales of £885 million grew 22% AER, 29% CER with sales up 22% AER, 29% CER to £874 million, benefitting from lupus nephritis launches in US and Japan in H2 2020.
Benlysta
Oncology
Sales of, 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.
Zejula
Blenrep
Blenrep
19
Pandemic sales
Sales of 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.
Xevudy
Established Pharmaceuticals
Sales of Established Pharmaceuticals in the year were £7,757 million, down 11% AER, 6% CER.
Established Respiratory products decreased 7% AER, 2% CER to £4,327 million. This includes the impact of generic competition to in Japan, and to globally. The decrease was partially offset by approximately 6 percentage points impact on growth of favourable prior period RAR adjustments.
Xyzal
Advair/Seretide
The remainder of the Established Pharmaceuticals portfolio decreased by 16% AER, 11% CER to £3,430 million on lower demand for antibiotics during the COVID-19 pandemic period, the divestment of GSK’s cephalosporin products at the start of the fourth quarter, and the impact of government mandated changes increasing use of generics in markets including France, Japan and China.
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 | ) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Pandemic Vaccines |
6,331 | 6,982 | (9 | ) | (5 | ) | ||||||||||
| 447 | — | — | — | |||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 6,778 | 6,982 | (3 | ) | 2 | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Vaccines turnover in the year decreased 3% at AER, but grew 2% CER to £6,778 million, primarily driven by pandemic adjuvant sales, partially offset by lower demand for routine adult vaccination due to COVID-19 vaccination programme deployment and disease circulation across regions, resulting in lower and Hepatitis vaccines sales. Unfavourable US prior period RAR adjustments reduced overall Vaccines growth by approximately 2 percentage points, particularly in and where the impact on product growth was a decrease of 7% and a decrease of 2% respectively.
Shingrix
Fluarix/ FluLaval
Shingrix
Vaccines turnover excluding pandemic vaccines decreased 9% AER, 5% CER to £6,331 million.
Meningitis
Meningitis sales decreased 7% AER, 2% CER to £961 million driven primarily by unrepeated International tender volumes for other meningitis vaccines. sales were stable at AER, but grew 5% CER to £650 million, reflecting increased market share in the US.
Bexsero
Menveo
Influenza
Fluarix/FluLaval
Shingles
Shingrix
Shingrix
Established Vaccines
Hepatitis vaccines sales were down 20% AER, 16% CER to £460 million, adversely impacted by de-prioritisation of routine US adult vaccination, 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 (, and ) decreased 4% AER but grew 1% CER. 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.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.
Infanrix
Pediarix
Boostrix
Infanrix/ Pediarix
Boostrix
Rotarix
Synflorix
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.
20
Consumer Healthcare turnover
| 2021 £m |
2020 £m |
Growth £% |
Growth CER% |
|||||||||||||
| Oral health |
2,732 | 2,753 | (1 | ) | 5 | |||||||||||
| Pain relief |
2,276 | 2,219 | 3 | 7 | ||||||||||||
| Vitamins, minerals and supplements |
1,512 | 1,506 | — | 4 | ||||||||||||
| Respiratory health |
1,133 | 1,209 | (6 | ) | (1 | ) | ||||||||||
| Digestive health and other |
1,803 | 1,824 | (1 | ) | 4 | |||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Brands divested/under review |
9,456 | 9,511 | (1 | ) | 4 | |||||||||||
| 151 | 522 | (71 | ) | (69 | ) | |||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 9,607 | 10,033 | (4 | ) | — | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 2021 £m |
2020 £m |
Growth £% |
Growth CER% |
|||||||||||||
| US |
3,179 | 3,408 | (7 | ) | (1 | ) | ||||||||||
| Europe |
2,468 | 2,619 | (6 | ) | (3 | ) | ||||||||||
| International |
3,960 | 4,006 | (1 | ) | 4 | |||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 9,607 | 10,033 | (4 | ) | — | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
Consumer Healthcare turnover in the year of £9,607 million decreased 4% AER and was stable at CER reflecting dilution from divestments given the completion of the portfolio rationalisation at the end of Q1 2021.
Sales excluding brands divested/under review decreased 1% AER but increased 4% CER reflecting the underlying strength of brands across the portfolio and categories and continuing growth in e-commerce. Overall, sales benefited from strong growth across all categories excluding Respiratory health which was negatively impacted in Q1 2021 by the historically low cold and flu season. The decrease in cold and flu sales resulted in an approximately 1% drag on full year growth.
International sales excluding brands divested/under review grew high single digit on a CER basis with double digit growth in emerging markets including India, China, the Middle East and Africa. Excluding brands divested/under review, US sales grew low single digits but European sales were stable on a CER basis. Both regions were particularly negatively impacted by the historically low cold and flu season during Q1 2021.
Oral health
Oral health sales decreased 1% AER, but grew 5% CER to £2,732 million. delivered high single digit growth reflecting underlying brand strength, continued innovation and strong growth across key markets including the US, China, India and Japan. Gum health also delivered broad based high single digit growth across key markets. Denture care grew low single digits driven partly by a return to growth in Q4 2021.
Sensodyne
Pain relief
Pain relief sales increased 3% AER, 7% CER to £2,276 million. , which benefitted from seasonal demand in the last quarter, grew double digits. grew mid-single digits, offsetting the expected short-term decrease in the second half of the year in the US after the introduction of private label competition earlier in 2021. delivered growth of over 40% versus a prior year decrease reflecting supply improvements.
Panadol
Voltaren
Excedrin
Vitamins, minerals and supplements
Vitamins, minerals and supplements sales were stable at AER but grew 4% CER to £1,512 million building on the significant (19% CER) growth in 2020. grew mid-teens percent driven by successful innovation, improved supply capacity in the US and continued consumer focus on health and wellness. grew mid-single digits and decreased high-single digits reflecting a particularly challenging 2020 comparator due to unprecedented demand during the early stages of the pandemic.
Centrum
Caltrate
Emergen-C
Respiratory health
Respiratory health sales decreased 6% AER, 1% CER to £1,133 million. In Q4 2021, cold and flu sales rebounded strongly and were above 2019 levels in Europe and slightly below 2019 levels in the US. For the full year, cold and flu products were down mid-single digits as the H2 2021 rebound was insufficient to offset the considerable decrease in the first quarter of 2021 which resulted from historically low demand for cold and flu products, effectively halving the global market in the period. Allergy products grew mid-single digits.
Digestive health and other
Digestive health and other brands sales decreased 1% AER but grew 4% CER to £1,803 million. Digestive health brands were up high-single digits with particularly strong growth in and . Skin health and Smoker’s health brands were up mid- single digits, offset partly by a decrease in small, non-strategic brands.
Tums
Eno
Cost of sales
| 2021 £m |
2020 £m |
Growth £% |
Growth CER% |
|||||||||||||
| Total cost of sales |
(11,603 | ) | (11,704 | ) | (1 | ) | 2 | |||||||||
| Adjusted cost of sales |
(10,726 | ) | (10,191 | ) | 5 | 8 | ||||||||||
Total cost of sales as a percentage of turnover was 34.0%, 0.3 percentage points lower at AER and 1.1 percentage points lower in CER terms compared with 2020. This primarily reflected lower write-downs in a number of manufacturing sites and the unwind in 2020 of the fair market value uplift on inventory arising on completion of the Consumer Healthcare Joint Venture with Pfizer.
Excluding these and other Adjusting items, Adjusted cost of sales as a percentage of turnover was 31.4%, 1.6 percentage points higher at AER and 0.8 percentage points higher at CER compared with 2020. This primarily reflected higher pandemic sales () as well as higher supply chain costs in Vaccines resulting from lower demand and higher inventory adjustments and higher commodity and freight costs in Consumer Healthcare, partly offset by price benefits in Pharmaceuticals, including the benefit from prior period RAR adjustments, a further contribution from restructuring savings across all three businesses and favourable mix in Vaccines.
Xevudy
21
Selling, general and administration
| 2021 £m |
2020 £m |
Growth £% |
Growth CER% |
|||||||||||||
| Total selling, general and administration |
(10,975 | ) | (11,456 | ) | (4 | ) | — | |||||||||
| Adjusted selling, general and administration |
(10,225 | ) | (10,717 | ) | (5 | ) | (1 | ) | ||||||||
Total SGA costs as a percentage of turnover were 32.2%, 1.4 percentage points lower at AER and 1.8 percentage points lower at CER compared with 2020. This included increased separation costs partly offset by lower restructuring charges.
Excluding Adjusting items, Adjusted SGA costs as a percentage of turnover were 30.0%, 1.5 percentage points lower at AER than in 2020 and 1.8 percentage points lower on a CER basis. Adjusted SGA costs decreased 5% AER, 1% CER 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 Pharmaceuticals, Consumer Healthcare 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 £m |
2020 £m |
Growth £% |
Growth CER% |
|||||||||||||
| Total research and development |
(5,278 | ) | (5,098 | ) | 4 | 7 | ||||||||||
| Adjusted research and development |
(4,776 | ) | (4,603 | ) | 4 | 8 | ||||||||||
Total RD expenditure was £5,278 million (15.5% of turnover), up 4% AER, 7% CER, including an increase in impairments partly offset by a decrease in major restructuring charges.
Adjusted RD expenditure was £4,776 million (14.0% of turnover), 4% higher at AER, 8% higher at CER than in 2020. Adjusting items reconciling Adjusted RD expenditure to Total RD expenditure are not allocated by business and therefore Total RD expenditure by business is not presented. Please see pages 12 to 13 above for the reconciliation of Adjusted RD expenditure to Total RD expenditure.
Pharmaceuticals Adjusted RD expenditure was £3,578 million (20.2% of turnover), stable at AER, up 4% CER, 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 Pharmaceuticals and Vaccines as part of the Separation preparation restructuring programme.
The growth of the Specialty portfolio in 2021 was primarily driven by our two programmes for COVID-19 treatment (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 , 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.
Xevudy
Blenrep
Adjusted RD expenditure in Vaccines was £887 million (13.1% of turnover), up 29% AER, 34% CER, reflecting 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. Adjusted RD expenditure in Consumer Healthcare was £249 million.
Royalty income
Royalty income was £419 million (2020 – £318 million), up 32% AER, 32% CER, primarily driven by higher sales of Gardasil.
Other operating income/(expense)
Net other operating expenses of £476 million (2020 – £1,624 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 disposal of a number of Consumer Healthcare brands 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 £6,201 million compared with £7,783 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, lower re-measurement charges on the contingent consideration liabilities and the unwind in 2020 of the fair market value uplift on inventory arising on completion of the Consumer Healthcare Joint Venture with Pfizer.
Excluding these and other Adjusting items, Adjusted operating profit was £8,806 million, 1% lower than 2020 at AER, but 9% higher at CER on a turnover increase of 5% CER. The Adjusted operating margin of 25.8% was 0.3 percentage points lower at AER, 0.9 percentage points higher on a CER basis than in 2020.
22
The increase in Adjusted operating profit primarily reflected the benefit from incremental pandemic sales ( and adjuvant) contributing approximately 6% AER, 7% CER to Adjusted Operating profit growth. Adjusted Operating profit also benefited from sales growth in Pharmaceuticals including the benefit from prior period RAR adjustments and tight control of ongoing costs including reduced promotional and variable spending across all three businesses 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. This was partly offset by lower sales in Vaccines, primarily, higher supply chain costs in Vaccines and Consumer Healthcare, divestments in Consumer Healthcare and increased investment in RD across Vaccines and Pharmaceuticals.
Xevudy
Shingrix
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
Pharmaceuticals operating profit was £4,681 million, up 12% AER, 24% CER on a turnover increase of 10% CER. The operating margin of 26.4% was 1.9 percentage points higher at AER than in 2020 and 3.3 percentage points higher on a CER basis. This primarily reflected price benefits in Pharmaceuticals, including the benefit from a prior period RAR adjustment, reduced supply chain costs, 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 and the continuing benefit of restructuring. This was partly offset by support to launches in HIV and increased investment in RD.
Vaccines operating profit was £2,256 million, down 17% AER, 11% CER on 2% turnover increase at CER. The operating margin of 33.3% was 5.6 percentage points lower at AER than in 2020 and 4.8 percentage points lower on a CER basis. This was primarily driven by higher supply chain costs resulting from higher inventory adjustments and lower demand, along with higher RD spend to support key strategic priorities and increased SGA investment to support business growth, partly offset by higher royalty income and pandemic adjuvant beneficial mix.
Consumer Healthcare operating profit was £2,239 million, up 1% AER, 9% CER on stable turnover at CER. The operating margin of 23.3% was 1.2 percentage points higher at AER and 2.0 percentage points higher on a CER basis than in 2020. This primarily reflected sales growth of continuing brands, price increases and favourable mix, synergy delivery from the Pfizer Joint Venture Integration and tight cost control, partially offset by the impact of divestments (1.2 percentage points), increased advertising and promotion investment, increased commodity and freight costs and investment in manufacturing sites.
Net finance costs
| Finance income |
2021 £m |
2020 £m |
||||||
| Interest and other income |
26 | 39 | ||||||
| Fair value movements |
2 | 5 | ||||||
| |
|
|
|
|||||
| 28 | 44 | |||||||
| |
|
|
|
|||||
| Finance expense |
||||||||
| Interest expense |
(746 | ) | (822 | ) | ||||
| Unwinding of discounts on provisions |
(2 | ) | (3 | ) | ||||
| Remeasurements and fair value movements |
— | (4 | ) | |||||
| Finance expense on lease liabilities |
(31 | ) | (40 | ) | ||||
| Other finance expense |
(5 | ) | (23 | ) | ||||
| |
|
|
|
|||||
| (784 | ) | (892 | ) | |||||
| |
|
|
|
|||||
Total net finance costs were £756 million compared with £848 million in 2020. Adjusted net finance costs were £753 million compared with £844 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).
Loss on disposal of interests 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 £5,442 million compared with £6,968 million in 2020.
23
Taxation
| 2021 £m |
2020 £m |
|||||||
| UK current year charge |
132 | 30 | ||||||
| Rest of world current year charge |
1,044 | 1,177 | ||||||
| Charge in respect of prior periods |
172 | 66 | ||||||
| |
|
|
|
|||||
| Total current taxation |
1,348 | 1,273 | ||||||
| Total deferred taxation |
(1,002 | ) | (693 | ) | ||||
| |
|
|
|
|||||
| Taxation on total profits |
346 | 580 | ||||||
| |
|
|
|
|||||
The charge of £346 million represented an effective tax rate on Total results of 6.4% (2020 – 8.3%) and reflected the different tax effects of the various Adjusting items, including a credit of £397 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 £1,415 million and represented an effective Adjusted tax rate of 17.5% (2020 – 16.0%).
Issues related to taxation are described in Note 14, ‘Taxation’, to the financial statements 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 £711 million (2020 – £639 million). The increase was primarily due to an increased allocation of Consumer Healthcare Joint Venture profits of £460 million (2020 – £374 million) and an increased allocation of ViiV Healthcare profits of £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 £1,006 million (2020 – £1,031 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. The allocation of Consumer Healthcare Joint Venture profits was £515 million (2020 – £515 million).
Earnings per share
Total EPS was 87.6p compared with 115.5p 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 £397 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 113.2p compared with 115.9p in 2020, down 2% AER but up 9% CER, on a 9% CER increase in Adjusted operating profit primarily reflecting incremental pandemic sales, sales increases in Pharmaceuticals, tight cost control and favourable legal settlements and lower interest costs, partly offset by lower sales in Vaccines, primarily , higher supply chain costs in Vaccines, increased RD investment and a higher effective tax rate. The contribution to growth from COVID-19 solutions was approximately 8% AER, 9% CER.
Shingrix
Dividends
The Board has declared four interim dividends resulting in a total dividend for the year of 80 pence, in line with the dividend declared for 2020. See note 16 to the financial statements, ‘Dividends’, 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. The dividend policy, the total expected cash distribution, and the respective dividend pay-out ratios for new GSK and new Consumer Healthcare remain unchanged.
GSK expects to declare a 27p per share dividend payable by the current group for the first half. This comprises 22 pence per share for new GSK and 5 pence per share representing Consumer Healthcare during the first half whilst part of the group. For the second half of 2022, new GSK continues to expect to declare a 22p per share dividend. As previously communicated, new GSK would expect to declare a dividend of 45 pence per share for 2023.
Following separation, the dividend policy for the new Consumer Healthcare company will be the responsibility of its Board of Directors and is expected to be guided by a 30 to 50 per cent pay-out ratio. On this basis, we now expect a second-half dividend from the new Consumer Healthcare company equivalent to a payout of around 3 pence per share, subject to its Board’s decisions on the intra-year phasing of dividend payments. This expected distribution per share for the second half of the year has been adjusted from that highlighted at the GSK Investor Update in June 2021 to reflect the total number of shares (up to circa 9.25 billion shares) in the new Consumer Healthcare company that are expected to be in issue upon demerger. In June 2021 the planning assumption for the Investor Update reflected only the GSK shares in issue at that time (circa 5 billion shares).
In aggregate, this would represent on the full year 2022 basis the equivalent of a Group dividend of around 52p per share. Dividends payable by Consumer Healthcare will only be receivable by shareholders who remain invested in Consumer Healthcare post-separation and at the appropriate record dates.
24
Adjusting items
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 £626 million (2020 – £1,532 million), analysed as follows:
| 2021 | 2020 | |||||||||||||||||||||||
| Cash £m |
Non- cash £m |
Total £m |
Cash £m |
Non- cash £m |
Total £m |
|||||||||||||||||||
| 2018 major restructuring programme (incl. Tesaro) |
18 | 9 | 27 | 105 | 210 | 315 | ||||||||||||||||||
| Consumer Healthcare Joint Venture integration programme |
173 | 11 | 184 | 298 | 28 | 326 | ||||||||||||||||||
| Separation Preparation restructuring programme |
371 | 59 | 430 | 625 | 216 | 841 | ||||||||||||||||||
| Combined restructuring and integration programme |
8 | (23 | ) | (15 | ) | 39 | 11 | 50 | ||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| 570 | 56 | 626 | 1,067 | 465 | 1,532 | |||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Cash charges of £371 million under the Separation Preparation programme primarily arose from restructuring of some administrative and central manufacturing functions as well as commercial pharmaceuticals and RD functions. The non-cash charges of £59 million primarily reflected write-down of assets in administrative locations and RD sites.
Cash charges of £173 million on the Consumer Healthcare Joint Venture programme primarily related to severance and integration costs. The non-cash credit in the Combined restructuring and integration programme primarily reflected a write back on disposal of a site.
Total cash payments made in 2021 were £753 million (2020 – £737 million), £434 million (2020 – £152 million) relating to the Separation Preparation restructuring programme, a further £176 million (2020 – £291 million) relating to the Consumer Healthcare Joint Venture integration programme, £95 million (2020 – £179 million) under the 2018 major restructuring programme including the settlement of certain charges accrued in previous quarters and £48 million (2020 – £115 million) for the existing Combined restructuring and integration programme.
The analysis of Major restructuring charges by business was as follows:
| 2021 £m |
2020 £m |
|||||||
| Pharmaceuticals |
233 | 671 | ||||||
| Vaccines |
(40 | ) | 214 | |||||
| Consumer Healthcare |
196 | 374 | ||||||
| |
|
|
|
|||||
| Corporate and central functions |
389 | 1,259 | ||||||
| 237 | 273 | |||||||
| |
|
|
|
|||||
| Total Major restructuring charges |
626 | 1,532 | ||||||
| |
|
|
|
|||||
The analysis of Major restructuring charges by income statement line was as follows:
| 2021 £m |
2020 £m |
|||||||
| Cost of sales |
154 | 667 | ||||||
| Selling, general and administration |
426 | 659 | ||||||
| Research and development |
46 | 206 | ||||||
| Other operating income/(expense) |
— | — | ||||||
| |
|
|
|
|||||
| Total Major restructuring charges |
626 | 1,532 | ||||||
| |
|
|
|
|||||
The benefit in the year from restructuring programmes was £0.7 billion, the benefit from the Separation Preparation restructuring programme was £0.3 billion, the benefit from the Consumer Healthcare Joint Venture integration was £0.2 billion and the benefit from the 2018 Restructuring programme was £0.2 billion.
The 2018 major restructuring programme, including Tesaro, has 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 and therefore GSK will cease external reporting of total costs and benefits of the 2018 major restructuring programme from 2022 onwards.
The completion of the Consumer Healthcare Joint Venture with Pfizer has realised substantial cost synergies and has largely delivered the expected total annual cost savings of £0.5 billion by 2021. The cash costs are expected to be £0.7 billion and non-cash charges expected to be £0.1 billion, plus additional capital expenditure of £0.2 billion. Up to 25% of the cost savings are intended to be reinvested in the business to support innovation and other growth opportunities.
25
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 aims 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 |
The programme continues to target delivery of £0.8 billion of annual savings by 2022 and £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 resulted in a net charge of £1,159 million (2020 – £1,308 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 £m |
2020 £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 | ||||||
| Release of fair value uplift on acquired Pfizer inventory |
— | 91 | ||||||
| Other adjustments |
58 | (17 | ) | |||||
| |
|
|
|
|||||
| Total transaction-related charges |
1,159 | 1,308 | ||||||
| |
|
|
|
|||||
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.
The ViiV Healthcare contingent consideration liability is fair valued under IFRS. The potential impact of the COVID-19 pandemic remains uncertain and at 31 December 2021, it has been assumed that there will be no significant impact on the long-term value of the liability. This position remains under review and the amount of the liability will be updated in future quarters as further information on the impact of the pandemic becomes available. 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 and disposal of a number of Consumer Healthcare brands, 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. The Consumer Healthcare brands disposal programme is complete and has delivered net proceeds of £1.1 billion. 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 £26 million (2020 – £7 million) was recorded for significant legal matters arising in the period. Significant legal cash payments were £5 million (2020 – £9 million). Included within Divestments, significant legal and other items, is a deferred tax credit of £157 million arising on the transfer of intellectual property within the group during the quarter. This deferred tax credit arises due to differences between group value and the market value of the assets transferred.
Separation costs
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”). Total Separation costs incurred in 2021 were £314 million (2020 – £68 million). This includes £38 million relating to transaction costs including preparatory admission costs (costs relating to achieve a listing).
Total separation costs are estimated to be £600-700 million, excluding transaction costs.
26
Cash generation and conversion
A summary of the consolidated cash flow statement is set out below.
| 2021 £m |
2020 £m |
|||||||
| Net cash inflow from operating activities |
7,952 | 8,441 | ||||||
| Net cash inflow/(outflow) from investing activities |
(1,777 | ) | 2,161 | |||||
| Net cash outflow from financing activities |
(7,589 | ) | (10,132 | ) | ||||
| Increase in cash and bank overdrafts |
(1,414 | ) | 470 | |||||
| Cash and bank overdrafts at beginning of year |
5,262 | 4,831 | ||||||
| Increase in cash and bank overdrafts |
(1,414 | ) | 470 | |||||
| Exchange adjustments |
(29 | ) | (39 | ) | ||||
| |
|
|
|
|||||
| 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 adverse exchange impacts, increased trade receivables, adverse timing of RAR and increased separation costs, partly offset by improved adjusted operating profit at CER and reduced tax payments including tax on disposals.
Capital expenditure and financial investment
Cash payments for tangible and intangible fixed assets amounted to £2,931 million (2020 – £2,239 million) and disposals realised £898 million (2020 – £1,582 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 £m |
2020 £m |
|||||||
| Free cash inflow |
4,437 | 5,406 | ||||||
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.
Reconciliation of net cash inflow from operating activities to free cash flow
A reconciliation of net cash inflow from operating activities, which is the closest equivalent IFRS measure to free cash flow, is shown below.
| 2021 £m |
2020 £m |
|||||||
| Net cash inflow from operating activities |
7,952 | 8,441 | ||||||
| Purchase of property, plant and equipment |
(1,172 | ) | (1,226 | ) | ||||
| Purchase of intangible assets |
(1,759 | ) | (1,013 | ) | ||||
| Proceeds from sale of property, plant and equipment |
143 | 68 | ||||||
| Proceeds from disposal of intangible assets |
772 | 1,255 | ||||||
| Interest paid |
(786 | ) | (864 | ) | ||||
| Interest received |
27 | 39 | ||||||
| Dividends from associates and joint ventures |
9 | 31 | ||||||
| Contingent consideration paid (reported in investing activities) |
(114 | ) | (120 | ) | ||||
| Contribution from non-controlling interests |
7 | 3 | ||||||
| Distributions to non-controlling interests |
(642 | ) | (1,208 | ) | ||||
| |
|
|
|
|||||
| Free cash flow |
4,437 | 5,406 | ||||||
| |
|
|
|
|||||
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, including potentially acquiring increased ownership interests in the ViiV Healthcare business where a minority shareholder hold put options. 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.
27
Financial position and resources
| 2021 £m |
2020 £m |
|||||||
| Assets |
||||||||
| Non-current assets |
||||||||
| Property, plant and equipment |
9,932 | 10,176 | ||||||
| Right of use assets |
740 | 830 | ||||||
| Goodwill |
10,552 | 10,597 | ||||||
| Other intangible assets |
30,079 | 29,824 | ||||||
| Investments in associates and joint ventures |
88 | 364 | ||||||
| Other investments |
2,126 | 3,060 | ||||||
| Deferred tax assets |
5,218 | 4,287 | ||||||
| Derivative financial instruments |
18 | 5 | ||||||
| Other non-current assets |
1,676 | 1,041 | ||||||
| |
|
|
|
|||||
| Total non-current assets |
60,429 | 60,184 | ||||||
| |
|
|
|
|||||
| Current assets |
||||||||
| Inventories |
5,783 | 5,996 | ||||||
| Current tax recoverable |
486 | 671 | ||||||
| Trade and other receivables |
7,860 | 6,952 | ||||||
| Derivative financial instruments |
188 | 152 | ||||||
| Liquid investments |
61 | 78 | ||||||
| Cash and cash equivalents |
4,274 | 6,292 | ||||||
| Assets held for sale |
22 | 106 | ||||||
| |
|
|
|
|||||
| Total current assets |
18,674 | 20,247 | ||||||
| |
|
|
|
|||||
| Total assets |
79,103 | 80,431 | ||||||
| |
|
|
|
|||||
| Liabilities |
||||||||
| Current liabilities |
||||||||
| Short-term borrowings |
(3,601 | ) | (3,725 | ) | ||||
| Contingent consideration liabilities |
(958 | ) | (765 | ) | ||||
| Trade and other payables |
(17,554 | ) | (15,840 | ) | ||||
| Derivative financial instruments |
(227 | ) | (221 | ) | ||||
| Current tax payable |
(489 | ) | (545 | ) | ||||
| Short-term provisions |
(841 | ) | (1,052 | ) | ||||
| |
|
|
|
|||||
| Total current liabilities |
(23,670 | ) | (22,148 | ) | ||||
| |
|
|
|
|||||
| Non-current liabilities |
||||||||
| Long-term borrowings |
(20,572 | ) | (23,425 | ) | ||||
| Corporation tax payable |
(180 | ) | (176 | ) | ||||
| Deferred tax liabilities |
(3,556 | ) | (3,600 | ) | ||||
| Pensions and other post-employment benefits |
(3,113 | ) | (3,650 | ) | ||||
| Other provisions |
(630 | ) | (707 | ) | ||||
| Derivative financial instruments |
(1 | ) | (10 | ) | ||||
| Contingent consideration liabilities |
(5,118 | ) | (5,104 | ) | ||||
| Other non-current liabilities |
(921 | ) | (803 | ) | ||||
| |
|
|
|
|||||
| Total non-current liabilities |
(34,091 | ) | (37,475 | ) | ||||
| |
|
|
|
|||||
| Total liabilities |
(57,761 | ) | (59,623 | ) | ||||
| |
|
|
|
|||||
| Net assets |
21,342 | 20,808 | ||||||
| |
|
|
|
|||||
| Total equity |
21,342 | 20,808 | ||||||
| |
|
|
|
|||||
28
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 and equipment 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 2021 was £20,778 million, with a net book value of £9,932 million. Of this, land and buildings represented £3,667 million, plant and equipment £4,558 million and assets in construction £1,707 million. In 2021, we invested £1,205 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 2021, we had contractual commitments for future capital expenditure of £616 million. We believe that our property and plant facilities are adequate for our current needs.
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 page 39 to 40 of the GSK Annual Report 2021, which is incorporated by reference herein, and in “Note 46 – Legal Proceedings” to the financial statements incorporated by reference in Item 18 below.
Right of use assets
Right of use assets amounted to £740 million at 31 December 2021 compared with £830 million on 1 January 2021. The decrease in the year reflected the impact of depreciation and disposals of £213 million and £70 million respectively, partly offset by additions of £215 million.
Goodwill
Goodwill decreased to £10,552 million at 31 December 2021, from £10,597 million.
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 2021 was £30,079 million (2020 – £29,824 million). The increase primarily reflected additions, net of disposals and write offs of £1,913 million, offset by amortisation and impairment losses, net of reversals, in the year of £1,597 million.
Investments in associates and joint ventures
We held investments in associates and joint ventures with a carrying value at 31 December 2021 of £88 million (2020 – £364 million). In 2021, the Group sold all of its shares in Innoviva Inc. back to Innoviva. Following this divestment, the Group held no investment in associates or joint ventures which are listed entities. See Note 21 to the financial statements, ‘Investments in associates and joint ventures’, incorporated by reference in Item 18 below.
Other investments
We held other investments with a carrying value at 31 December 2021 of £2,126 million (2020 – £3,060 million). The highest value investments held at 31 December 2021 were in CureVac AG, which had a book value at 31 December 2021 of £380 million (2020 - £887 million) and Vir Biotechnology, which had a book value of £266 million (2020 – £130 million). 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 £188 million (2020 – £152 million) and non-current derivative financial assets held at fair value of £18 million (2020 – £5 million). The majority of these financial instruments related to foreign exchange contracts both designated and not designated as accounting hedges.
Inventories
Inventory of £5,783 million decreased from £5,996 million in 2020.
Trade and other receivables
Trade and other receivables of £7,860 million increased from £6,952 million in 2020.
Deferred tax assets
Deferred tax assets amounted to £5,218 million (2020 – £4,287 million) at 31 December 2021.
Derivative financial instruments: liabilities
We held current and non-current derivative financial liabilities at fair value of £228 million (2020 – £231 million). This primarily related to foreign exchange contracts both designated and not designated as accounting hedges.
Trade and other payables
At 31 December 2021, trade and other payables were £17,554 million compared with £15,840 million at 31 December 2020. The increase primarily reflected the impact of higher customer return and rebate accruals and higher accruals relating to our collaborations. See Note 28 to the financial statements, ‘Trade and other payables’, incorporated by reference in Item 18 below.
Provisions
We carried deferred tax provisions and other short-term and non-current provisions of £5,027 million at 31 December 2021 (2020 – £5,359 million). Other provisions at the year-end included £196 million (2020 – £320 million) related to legal and other disputes and £652 million (2020 – £860 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.
29
Pensions and other post-employment benefits
We account for pension and other post-employment arrangements in accordance with IAS 19. The net deficits were £1,129 million (2020 – £2,104 million) on pension arrangements and £1,243 million (2020 – £1,363 million) on unfunded post-employment liabilities. See Note 30 to the financial statements, ‘Pensions and other post-employment benefits’, incorporated by reference in Item 18 below.
Other non-current liabilities
Other non-current liabilities amounted to £921 million at 31 December 2021 (2020 – £803 million).
Contingent consideration liabilities
Contingent consideration amounted to £6,076 million at 31 December 2021 (2020 – £5,869 million), of which £5,559 million (2020 – £5,359 million) represented the estimated present value of amounts payable to Shionogi relating to ViiV Healthcare and £479 million (2020 – £477 million) represented the estimated present value of contingent consideration payable to Novartis related to the Vaccines acquisition.
The liability due to Shionogi included £231 million in respect of preferential dividends. The liability for preferential dividends due to Pfizer at 31 December 2021 was £nil (2020 – £1 million). An explanation of the accounting for the non-controlling interests in ViiV Healthcare is set out above under “Reporting framework”.
Of the total contingent consideration payable (on a post-tax basis) at 31 December 2021, £958 million (2020 – £765 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 impact of the settlement with Gilead on the contingent consideration liability (CCL) is 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 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%.
30
Net debt
| 2021 £m |
2020 £m |
|||||||
| Cash, cash equivalents and liquid investments |
4,335 | 6,370 | ||||||
| Borrowings – repayable within one year |
(3,601 | ) | (3,725 | ) | ||||
| Borrowings – repayable after one year |
(20,572 | ) | (23,425 | ) | ||||
| |
|
|
|
|||||
| Net debt |
(19,838 | ) | (20,780 | ) | ||||
| |
|
|
|
|||||
At 31 December 2021, net debt was £19.8 billion, compared with £20.8 billion at 31 December 2020, comprising gross debt of £24.1 billion and cash and liquid divestments of £4.3 billion. Net debt reduced due to £4.4 billion free cash flow and £0.5 billion proceeds from investments, including £0.3 billion proceeds from the Innoviva disposal and £0.3 billion of net favourable exchange impacts from the translation of non-Sterling denominated debt and exchange on other financing items partly offset by the dividends paid to shareholders of £4.0 billion and additional investments of £0.2 billion.
At 31 December 2021, GSK had short-term borrowings (including overdrafts and lease liabilities) repayable within 12 months of £3.6 billion and £4.0 billion repayable in the subsequent year.
At 31 December 2021, GSK’s cash and liquid investments were held as follows:
| 2021 £m |
2020 £m |
|||||||
| Bank balances and deposits |
2,825 | 3,000 | ||||||
| US Treasury and Treasury repo only money market funds |
54 | 317 | ||||||
| Liquidity funds |
1,395 | 2,975 | ||||||
| Cash and cash equivalents |
4,274 | 6,292 | ||||||
| Liquid investments – government securities |
61 | 78 | ||||||
| |
|
|
|
|||||
| 4,335 | 6,370 | |||||||
| |
|
|
|
|||||
Cash and liquid investments of £2.9 billion (2020 – £5.4 billion) were held centrally at 31 December 2021.
The analysis of cash and gross debt after the effects of hedging is as follows:
| 2021 £m |
2020 £m |
|||||||
| Cash and liquid investments |
4,335 | 6,370 | ||||||
| Gross debt – fixed |
(23,167 | ) | (24,538 | ) | ||||
| – floating |
(1,006 | ) | (2,612 | ) | ||||
| – non-interest bearing |
— | — | ||||||
| |
|
|
|
|||||
| Net debt |
(19,838 | ) | (20,780 | ) | ||||
| |
|
|
|
|||||
Movements in net debt
| 2021 £m |
2020 £m |
|||||||
| Net debt at beginning of year |
(20,780 | ) | (25,215 | ) | ||||
| (Decrease)/Increase in cash and bank overdrafts |
(1,414 | ) | 470 | |||||
| (Decrease)/Increase in liquid investments |
(18 | ) | 1 | |||||
| Increase in long-term loans |
— | (3,298 | ) | |||||
| Net repayment of short-term loans |
1,995 | 7,305 | ||||||
| Repayment of lease liabilities |
215 | 227 | ||||||
| Exchange movements |
314 | (135 | ) | |||||
| Other movements |
(150 | ) | (135 | ) | ||||
| |
|
|
|
|||||
| Net debt at end of year |
(19,838 | ) | (20,780 | ) | ||||
| |
|
|
|
|||||
Interest rate benchmark reform
Interest rate benchmark reform – Amendments to IFRS 9, IAS 39, IFRS 4, IFRS 7 and IFRS 16’ Phase I and Phase II were issued by the IASB in September 2019 and August 2020, and adopted by the UK Endorsement Board on 5 January 2021. Phase I of the amendment modifies specific hedge accounting requirements to allow hedge accounting to continue for affected hedges during the period of uncertainty before the hedged items or hedging instruments affected by the current interest rate benchmarks are amended as a result of the ongoing interest rate benchmark reforms. Phase II also provides that, for financial instruments measured using amortised cost measurement, changes to the basis for determining the contractual cash flows required by interest rate benchmark reform should be reflected by adjusting their effective interest rate and no immediate gain or loss should be recognised.
The Group has closely monitored the market and the output from the various industry working groups managing the transition to new benchmark interest rates. This includes announcements made by LIBOR regulators, including the Financial Conduct Authority (FCA) and the US Commodity Futures Trading Commission, regarding the transition away from LIBOR (including GBP LIBOR, USD LIBOR and EURIBOR) to the Sterling Overnight Index Average Rate (SONIA), the Secured Overnight Financing Rate (SOFR), and the Euro Short-Term Rate (€STR) respectively.
At 31 December 2021, the Group was not directly exposed to interest rate benchmark reform as it held no interest rate derivatives or floating rate debt that referenced to LIBOR. The Group did not transition any material derivatives or floating rate debt into a new index as all of the instruments referencing LIBOR matured before December 2021.
31
Total equity
At 31 December 2021, total equity had increased from £20,808 million at 31 December 2020 to £21,342 million. A summary of the movements in equity is set out below:
| 2021 £m |
2020 £m |
|||||||
| Total equity at beginning of year |
20,808 | 18,357 | ||||||
| Total comprehensive income for the year |
4,759 | 7,358 | ||||||
| Dividends to shareholders |
(3,999 | ) | (3,977 | ) | ||||
| Ordinary shares issued |
21 | 29 | ||||||
| Changes in non-controlling interests |
— | (131 | ) | |||||
| Transaction with non-controlling interest |
10 | — | ||||||
| Share-based incentive plans |
367 | 381 | ||||||
| Tax on share-based incentive plans |
11 | (4 | ) | |||||
| Contributions from non-controlling interests |
7 | 3 | ||||||
| Distributions to non-controlling interests |
(642 | ) | (1,208 | ) | ||||
| |
|
|
|
|||||
| Total equity at end of year |
21,342 | 20,808 | ||||||
| |
|
|
|
|||||
Share purchases
At 31 December 2021, GSK held 355.2 million shares as Treasury shares (2020 – 355.2 million shares), at a cost of £4,969 million (2020 – £4,969 million), which has been deducted from retained earnings.
No ordinary shares were repurchased in the period 1 January 2021 to 28 February 2022 and the company does not expect to make any ordinary share repurchases in the remainder of 2022.
In 2021, no Treasury shares were transferred to the Employee Share Ownership Plan (ESOP) Trusts. 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 2021, the ESOP Trusts held 23.2 million (2020 – 49.0 million) GSK shares against the future exercise of share options and share awards. The carrying value of £27 million (2020 – £194 million) has been deducted from other reserves. The market value of these shares was £371 million (2020 – £655 million).
On 10 February 2022, 50.3 million shares were transferred to the ESOP Trusts after which the Trusts held 72.9 million shares against the exercise of share options and share rewards.
Contingent liabilities
Other contingent liabilities are set out in Note 34 to the financial statements, ‘Contingent liabilities’, 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 | 9 | 2 | — | 1 | |||||||||||||||
| Other contingent liabilities |
114 | 13 | 12 | 31 | 58 | |||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||
| Total |
126 | 22 | 14 | 31 | 59 | |||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||
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 31 to the financial statements, ‘Other provisions’, 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 2021, 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 and Note 46 to the financial statements, ‘Legal proceedings’, incorporated by reference in Item 18 below.
32
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 14 October 2021. 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.
GSK’s long-term credit rating with Standard and Poor’s is A (stable outlook) and with Moody’s Investor Services (‘Moody’s’) is A2 (stable outlook). Our short-term credit ratings are A-1 and P-1 with Standard and Poor’s and Moody’s respectively.
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 from a 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 CFO 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 46 and 31) |
| • | Contingent consideration liabilities (Note 32) |
| • | Pensions and other post-employment benefits (Note 30). |
Information on the judgements and estimates made in these areas is given in Note 3 to the financial statements, ‘Critical accounting judgements and key sources of estimation uncertainty’, incorporated by reference in Item 18 below.
33
Turnover
In respect of the Turnover accounting policy, our largest business is US Pharmaceuticals, 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 Pharmaceuticals business:
| • | 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 the US Pharmaceuticals business is as follows:
| 2021 | 2020 | 2019 | ||||||||||||||||||||||
| £m | Margin % |
£m | Margin % |
£m | Margin % |
|||||||||||||||||||
| Gross turnover |
19,928 | 100 | 20,035 | 100 | 18,471 | 100 | ||||||||||||||||||
| Market-driven segments |
(6,656 | ) | (33 | ) | (6,754 | ) | (34 | ) | (5,976 | ) | (32 | ) | ||||||||||||
| Government mandated and state programmes |
(4,553 | ) | (23 | ) | (5,205 | ) | (26 | ) | (4,264 | ) | (23 | ) | ||||||||||||
| Cash discounts |
(377 | ) | (2 | ) | (388 | ) | (2 | ) | (356 | ) | (2 | ) | ||||||||||||
| Customer returns |
(117 | ) | (1 | ) | (117 | ) | (1 | ) | (141 | ) | (1 | ) | ||||||||||||
| Prior year adjustments |
838 | 4 | 402 | 2 | 247 | 1 | ||||||||||||||||||
| Other items |
(621 | ) | (3 | ) | (522 | ) | (2 | ) | (579 | ) | (3 | ) | ||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| Total deductions |
(11,486 | ) | (58 | ) | (12,584 | ) | (63 | ) | (11,069 | ) | (60 | ) | ||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| Net turnover |
8,442 | 42 | 7,451 | 37 | 7,402 | 40 | ||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
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.
The decreased deductions in the Government mandated and state programmes of the gross turnover to net turnover reconciliation primarily reflected lower rebates and chargebacks on respiratory products, and on in particular.
Advair
During the year accounted for 6% of US Pharmaceuticals turnover and approximately 21% of the total deduction for rebates and returns.
Advair
The respiratory portfolio as a whole, including Established Respiratory products, accounted for approximately 77% of the total deduction in the year.
The balance sheet accruals for rebates, discounts, allowances and returns for the US Pharmaceuticals and Vaccines businesses are managed on a combined basis. At 31 December 2021, the total accrual amounted to £5,044 million (2020 – £4,686 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 Pharmaceuticals and Vaccines inventory levels at wholesalers and in other distribution channels at 31 December 2021 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.
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 46 to the financial statements, ‘Legal proceedings’, incorporated by reference in Item 18 below.
34
Please refer to the “Financial review 2020” of the GSK Annual Report on Form 20-F for the year ended 31 December 2020 for a comparative discussion of 2020 financial results compared to 2019.
| 5.B | Liquidity and capital resources |
The information set forth under the heading “Note 43 – Financial instruments and related disclosures” on pages 228 to 244 of the GSK Annual Report 2021 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 26 – Cash and cash equivalents” on page 201 of the GSK Annual Report 2021 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 228 of the GSK Annual Report 2021 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 29 – Net debt” on pages 203 and 204; and |
| • | “Note 35 – Commitments” on page 216 |
of the GSK Annual Report 2021 is incorporated herein by reference.
Loans:
Intangible assets commitments:
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.
Lease obligations:
Property, plant and equipment:
Purchases commitments:
Future finance charges
Investments
Pensions:
There was a decrease in the commitments in 2021 as a result of a reduction in outstanding loan commitments.
| 5.C | Research and development, patents and licenses, etc. |
The information set forth under the headings:
| • | “Innovation” within “Our business model” on page 1; |
| • | “Innovation” within “Our long-term priorities” on page 10; |
| • | “Innovation” on pages 17 to 28; |
| • | “Pharmaceuticals and Vaccines product development pipeline” on pages 269 to 271; |
| • | “Pharmaceutical products, competition and intellectual property” on pages 272 to 273; |
| • | “Vaccines products, competition and intellectual property” on page 273; and |
| • | “Consumer Healthcare products and competition” on page 274 |
of the GSK Annual Report 2021 is incorporated herein by reference.
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| 5.D | Trend information |
The information set forth under the heading “Group Financial Review” 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 83 to 86; and |
| • | “GSK Leadership Team” on pages 87 to 88 |
of the GSK Annual Report 2021 is incorporated herein by reference.
| 6.B | Compensation |
The information set forth under the heading “Remuneration report” on pages 119 to 152; excluding:
| • | (i) the second sentence of the first paragraph and (ii) the last sentence of the sixth paragraph, in each case, on page 121; and |
| • | the heading and the information under the heading “2022 at a glance” on page 124 |
of the GSK Annual Report 2021 is incorporated herein by reference.
| 6.C | Board practices |
The information set forth under the heading:
| • | “Shareholder engagement and Board transition” within the “Chair’s statement” on page 4; |
| • | “Corporate governance” on pages 82 to 118, excluding: |
| • | the last sentence of the third paragraph on page 90; |
| • | the second bulleted paragraph under “Rejection of unsolicited proposals for the CH business” on page 97; and |
| • | the heading and the information under the heading “Section 172 statement” on page 116; and |
| • | “Service contracts and letters of appointment” on page 138 |
of the GSK Annual Report 2021 is incorporated herein by reference.
| 6.D | Employees |
The information set forth under the headings:
| • | “Note 9 – Employee costs” on page 185; |
| • | “Note 30 – Pensions and other post-employment benefits” on pages 205 to 213; and |
| • | “Number of employees” under “Five year record” on page 265 |
of the GSK Annual Report 2021 is incorporated herein by reference.
| 6.E | Share ownership |
The information set forth under the headings:
| • | “Note 44 – Employee share schemes” on pages 245 to 246; |
| • | “2021 Total remuneration” on pages 123 to 126 (excluding the heading and the information under the heading “2022 at a glance” on page 124); |
| • | “Value earned from long term incentives (LTIs)” on page 130; |
| • | “Update on performance of ongoing LTI awards” on page 131; and |
| • | “Directors’ interests in shares” on pages 140 to 141 |
of the GSK Annual Report 2021 is incorporated herein by reference.
| 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 117; |
| • | “Share capital and control” on pages 288 to 289; and |
| • | “Analysis of shareholdings at 31 December 2021” on page 290 |
of the GSK Annual Report 2021 is incorporated herein by reference.
| 7.B | Related party transactions |
The information set forth under the heading “Note 39 – Related party transactions” on page 221 of the GSK Annual Report 2021 is incorporated herein by reference.
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| 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 46 – Legal proceedings” on pages 248 to 250; and |
| • | “Dividends” on page 290 |
of the GSK Annual Report 2021 is incorporated herein by reference.
| 8.B | Significant Changes |
The information set forth under the heading “Note 46 – Legal proceedings” on pages 248 to 250 of the GSK Annual Report 2021 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 289; and |
| • | “Nature of trading market” on page 289 |
of the GSK Annual Report 2021 is incorporated herein by reference.
The trading symbol for GSK’s Ordinary Shares of 25p each on the London Stock Exchange is GSK.L and the trading symbol for GSK’s ADSs on the New York Stock Exchange 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 288; and |
| • | “Nature of trading market” on page 289 |
of the GSK Annual Report 2021 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.
| 10.B | Articles of Association of GlaxoSmithKline 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 he or she is 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 him or her in respect of his or her 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 he or she has failed to provide the company with information concerning his or her interests in Ordinary Shares within the prescribed period, as required by Section 793 of the Companies Act 2006.
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(b) Transfer of Ordinary Shares
Any shareholder may transfer his or her 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 his or her 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.
(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).
The rights conferred upon the holders of any Ordinary Shares shall not, unless otherwise expressly provided in the rights attaching to those Ordinary Shares, be deemed to be varied by the creation or issue of further shares ranking pari passu with them.
(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 12 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 six 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.
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(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 his or her 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 his or her 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 his office of director for such period and upon such terms, including remuneration, as the Directors may decide; |
| (iii) | act by himself or through a firm with which he is 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 his 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 his or her own appointment (including remuneration) or the terms of his or her termination of appointment or relating to any contract in which he or she has 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 (including amounts paid to any director who acts as chairman or is chairman of, or serves on any committee of the board of directors but 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 is appointed to any executive office, acts as Chairman, acts as senior independent director, acts as a scientific/medical expert on the board, is Chairman of, or serves on any committee of the Directors or performs any other 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 he or she incurs 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 his or her 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.
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(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 his or her period of office. No Director is required to retire by reason of his or her 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) | he resigns or offers to resign, and the board resolves to accept such offer; |
| (ii) | his resignation is requested by all of the other directors and all of the other directors are not less than three in number; |
| (iii) | he is or has been suffering from mental or physical ill health and the board resolves that his office be vacated; |
| (iv) | he is absent without permission of the board from meetings of the board (whether or not an alternate director appointed by him attends) for six consecutive months and the board resolves that his office is vacated; |
| (v) | he becomes bankrupt or compounds with his creditors generally; |
| (vi) | he is prohibited by law from being a director; or |
| (vii) | he is removed from office pursuant to the Articles or the Companies Acts. |
(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 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 joint venture. 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 has given customary and broadly reciprocal representations and warranties to each other under the SAPA. GSK and Pfizer have 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 have 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) has 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) has 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 has 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.
In connection with the closing of the transaction on July 31, 2019, GSK, Pfizer, GSK Consumer Healthcare and GSK Consumer Healthcare (No. 2) entered into a Shareholders’ Agreement in relation to the consumer healthcare joint venture (the “Shareholders’ Agreement”). Under the terms of the Shareholders’ Agreement, GSK has the right to appoint six directors to the board of the joint venture and the right to appoint the chair of the board of the joint venture, and Pfizer has the right to appoint three directors to the board of the joint venture. The Shareholders’ Agreement contains a list of customary reserved matters that may not be undertaken by the joint venture without the prior approval of Pfizer.
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The joint venture is permitted to make external borrowings up to an aggregate amount of £300 million, with external borrowings in excess of this level requiring Pfizer’s consent. In the event that the joint venture requires additional funding, the funding will be requested from GSK and Pfizer pro rata to their respective shareholdings. GSK and Pfizer will each be entitled to provide all (but not some only) of its proportion of the requested funds, but neither party will be obliged to provide such funding. Dividends will be paid to the shareholders in proportion to their respective interests in ordinary shares, and all readily available cash in excess of an agreed base cash figure of £300 million will be distributed subject to the availability of distributable reserves, there being no outstanding shareholder loans and after the payment of any dividends required to be paid on certain low-coupon preference shares held by GSK.
Under the Shareholders’ Agreement, each of GSK and Pfizer have agreed, subject to customary carve-outs, not to compete with the business of the consumer healthcare joint venture for a period of three years after completion of the transaction and not to acquire a business or interest in an entity in a competing business of the joint venture for six years after completion of the transaction.
At any time from completion of the transaction, GSK will have the right to require the listing and admission to trading of the shares of GSK Consumer Healthcare on the London Stock Exchange, the Nasdaq Stock Market or the New York Stock Exchange (a “Separation”). From five years from completion of the transaction, Pfizer will have the right to require a Separation. From 15 years after completion of the transaction, GSK will be entitled to require Pfizer to sell to GSK its entire shareholding in the consumer healthcare joint venture at a price reflecting the fully distributed public trading equity value of the joint venture at the relevant time. Neither GSK nor Pfizer may transfer its shares in the joint venture without the other’s consent.
The Shareholders’ Agreement will terminate immediately in the event that (i) only GSK or Pfizer remain holding shares in the joint venture or (ii) the shares of the joint venture have been listed and admitted to trading on a recognized stock exchange.
| 10.D | Exchange controls |
The information set forth under the heading “Exchange controls and other limitations affecting security holders” on page 288 of the GSK Annual Report 2021 is incorporated herein by reference.
| 10.E | Taxation |
The information set forth under the heading “Tax information for shareholders” on pages 292 to 293 of the GSK Annual Report 2021 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 291 of the GSK Annual Report 2021 is incorporated herein by reference.
| 10.I | Subsidiary information |
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 in Form 20-F is incorporated herein by reference.
The information set forth under the heading “Note 43 – Financial instruments and related disclosures” on pages 228 to 244 of the GSK Annual Report 2021 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
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
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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 2021 the Depositary made payments of approximately $12.90 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 112 of the GSK Annual Report 2021 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 New York Stock Exchange (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.
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 2021 and Form 20-F. In 2021 the Committee met 18 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 84 in the biography for “Charles Bancroft” and the second paragraph under “Board Committee information” on page 93 of the GSK Annual Report 2021.
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 2021 and Form 20-F; |
| • | based on their knowledge, the GSK Annual Report 2021 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 2021 and Form 20-F; |
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| • | 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 2021 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 2021 and Form 20-F any changes in internal controls over financial reporting during the period covered by the GSK Annual Report 2021 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 2021.
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, 2021, 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 8, 2022.
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; |
| • | management has assessed the effectiveness of internal control over financial reporting, as at 31 December 2021 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 2021 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, 2021, 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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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the shareholders and the Board of Directors of GlaxoSmithKline plc
Opinion on Internal Control over Financial Reporting
We have audited the internal control over financial reporting of GlaxoSmithKline plc and subsidiaries (the “Group”) as at 31 December 2021, based on criteria established in issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). In our opinion, the Group maintained, in all material respects, effective internal control over financial reporting as at 31 December 2021, based on criteria established in issued by COSO.
Internal Control — Integrated Framework (2013)
Internal Control — Integrated Framework (2013)
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated financial statements as at and for the year ended 31 December 2021, of the Group and our report dated 8 March 2022, expressed an unqualified opinion on those financial statements.
Basis for Opinion
The Group’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying “” included in Exhibit 15.2 of the Form 20-F. Our responsibility is to express an opinion on the Group’s internal control over financial reporting based on our audit. 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.
Section 404: Management’s annual report on internal control over financial reporting
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ Deloitte LLP
8 March 2022
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| Item 16. | [Reserved] |
| Item 16A. | Audit committee financial expert |
The information set forth under the headings:
| • | “Board Committee information” on page 93; and |
| • | “Sarbanes-Oxley Act of 2002” on page 296 |
of the GSK Annual Report 2021 is incorporated herein by reference.
| Item 16.B | Code of Ethics |
The information set forth under the heading “Code of Conduct and reporting lines” on page 115 of the GSK Annual Report 2021 is incorporated herein by reference. You will find the Code of Conduct at this link:
https://www.gsk.com/en-gb/about-us/policies-codes-and-standards/
. No waivers were granted from a provision of our code of ethics to an officer or person described in Item 16B(a) that relates to one or more of the items set forth in Item 16B(b) in 2021.
| Item 16.C | Principal Accountant Fees and Services |
Audit Fees for 2020 and 2021 were paid to Deloitte LLP (PCAOB ID No. 1147 ).
| 16C(a) | Audit Fees |
The information set forth in the table under the heading “Fees payable to the company’s auditor and its associates” in the rows named “Audit of parent company and consolidated financial statements including attestation under s.404 of Sarbanes-Oxley Act 2002” and “Audit of the company’s subsidiaries” in Note 8 – “Operating profit” on page 184 of the GSK Annual Report 2021 is incorporated herein by reference.
| 16C(b) | Audit-Related Fees |
The information set forth in the table under the heading “Fees payable to the company’s auditor and its associates” in the row named “Audit related and other assurance services” in Note 8 – “Operating profit” on page 184 of the GSK Annual Report 2021 is incorporated herein by reference. The other assurance services provided by the auditor relate to agreed upon procedures and other assurance services outside of statutory audit requirements.
| 16C(c) | Tax Fees |
Not applicable.
| 16C(d) | All Other Fees |
The information set forth in the table under the heading “Fees payable to the company’s auditor and its associates” in the row named “All other services” in Note 8 – “Operating profit” on page 184 of the GSK Annual Report 2021 is incorporated herein by reference.
| 16C(e) | The information set forth under the heading “Non-audit services” on page 114 of the GSK Annual Report 2021 is incorporated herein by reference. |
| 16C(f) | Not applicable. |
| Item 16.D | Exemptions from the Listing Standards for Audit Committees |
Not applicable.
| Item 16.E | Purchases of Equity Securities by the Issuer and Affiliated Purchasers |
Not applicable.
| Item 16.F | Change in Registrant’s Certifying Accountant |
Not applicable.
| Item 16.G | Corporate Governance |
Comparison of New York Stock Exchange Corporate Governance Standards and GlaxoSmithKline plc’s corporate governance practice. The application of the New York Stock Exchange’s (“NYSE”) corporate governance standards is restricted for foreign companies, recognizing that they have to comply with domestic requirements. As a foreign private issuer, GlaxoSmithKline plc (“GlaxoSmithKline” or the “Company”) must comply with the following NYSE standards:
| 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 GlaxoSmithKline’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. |
As a Company listed on the London Stock Exchange, GlaxoSmithKline is required to comply with the UK Listing Authority’s Listing Rules (the “Listing Rules”) and to report non-compliance with the UK Corporate Governance Code (the “UK Code”).
The table below discloses differences between GlaxoSmithKline’s current domestic corporate governance practices, which are based on the UK Code, and the NYSE corporate governance standards, applicable to US companies.
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NYSE Corporate Governance Standards |
Description of differences between GlaxoSmithKline’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). | GlaxoSmithKline 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 GlaxoSmithKline (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 GlaxoSmithKline’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 Charles Bancroft, Vindi Banga, Dr Anne Beal, Dr Vivienne Cox, Dr Hal Dietz, Lynn Elsenhans, Dr Laurie Glimcher, Dr Jesse Goodman and Urs Rohner 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) |
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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 |
GlaxoSmithKline complies with the corresponding domestic requirements contained in the UK Code, which sets out the principles for GlaxoSmithKline 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 GlaxoSmithKline within the last five years; (b) has, or has had within the last three years, a material business relationship with GlaxoSmithKline either directly or as a partner, shareholder, director or senior employee of a body that has such a relationship with GlaxoSmithKline; (c) has received or receives additional remuneration from GlaxoSmithKline apart from a director’s fee, participates in GlaxoSmithKline’s share option or a performance-related pay scheme, or is a member of GlaxoSmithKline’s pension scheme; (d) has close family ties with any of GlaxoSmithKline’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). | ||
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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”). |
GlaxoSmithKline 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 2021 and intends to comply with this requirement at its 2022 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 Chairman 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). GlaxoSmithKline 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 GlaxoSmithKline and the external facilitator should be identified in the Annual Report (Provision 21). Internally facilitated evaluations were conducted in 2015, 2016, 2018 and 2021. GlaxoSmithKline conducted an externally facilitated evaluation in 2014, 2017, 2019 and 2020. The Financial Reporting Council’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. | GlaxoSmithKline complies with the equivalent domestic requirements set out in the UK Code, which requires the Chair of GlaxoSmithKline 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 GlaxoSmithKline’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. |
GlaxoSmithKline complies with the corresponding domestic requirements set out in the UK Code, which requires GlaxoSmithKline to have a Nominations Committee that is comprised of a majority of independent Non-Executive Directors (Provision 17). In practice, GlaxoSmithKline’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). GlaxoSmithKline’s Nominations Corporate Governance Committee has written terms of reference in accordance with the UK Code. The terms of reference are available on GlaxoSmithKline’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 gender diversity), 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 GlaxoSmithKline’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 GlaxoSmithKline 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 GlaxoSmithKline’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). GlaxoSmithKline 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 t on all corporate governance matters (Provision 16). Domestic requirements do not mandate GlaxoSmithKline 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 “Independence Tests” above. (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. (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: |
GlaxoSmithKline complies with the equivalent domestic requirements set out in the UK Code, which requires GlaxoSmithKline to have a Remuneration Committee comprising at least three independent Non-Executive Directors (Provision 32). In practice, GlaxoSmithKline’s current Remuneration Committee is comprised entirely of independent directors within the meaning of the UK Code. GlaxoSmithKline’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 GlaxoSmithKline’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). 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 GlaxoSmithKline 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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| |
(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; (D) Any business or personal relationship of the compensation consultant, legal counsel or other adviser with a member of the compensation committee; |
(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 GlaxoSmithKline 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 effective engagement with shareholders and the workforce; (ii) the operation and rationale of remuneration structures are easy to understand; (iii) |
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| (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. |
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 GlaxoSmithKline 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. | GlaxoSmithKline complies with equivalent domestic requirements set out in the UK Code, which require that GlaxoSmithKline has an Audit Risk Committee that is comprised of at least three independent Non-Executive Directors (Provision 24). GlaxoSmithKline 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 GlaxoSmithKline 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 GlaxoSmithKline and any formal announcements relating to GlaxoSmithKline’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 GlaxoSmithKline’s position and performance, business model and strategy (Provision 25); | ||||
| (c) reviewing GlaxoSmithKline’s internal financial controls and internal control and risk management systems (Provision 25); | ||||
| (d) monitoring and reviewing the effectiveness of GlaxoSmithKline’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 GlaxoSmithKline may, in confidence, raise concerns about possible improprieties in matters of financial reporting or other matters (Provision 6). | ||||
| GlaxoSmithKline’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; | ||||
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| • 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 GlaxoSmithKline, 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 | ||||
| • GlaxoSmithKline must provide appropriate funding for the Audit Risk Committee. | ||||
| The Board has determined that Charles Bancroft has the appropriate qualifications and backgrounds 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 (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: |
GlaxoSmithKline 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). GlaxoSmithKline’s Audit Risk Committee has written terms of reference in accordance with the UK Code. The terms of reference are available on GlaxoSmithKline’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 GlaxoSmithKline’s performance, business model and strategy (Principle M Provision 27); and • when taking into account GlaxoSmithKline’s position and principal risks, how the prospects of GlaxoSmithKline 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 GlaxoSmithKline will be able to |
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| (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. |
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). 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 GlaxoSmithKline’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. | GlaxoSmithKline complies with corresponding domestic requirements in the Listing Rules, which mandate that GlaxoSmithKline 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) |
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| 9. | Listed companies must adopt and disclose corporate governance guidelines. | GlaxoSmithKline complies with corresponding domestic requirements in the Listing Rules and the UK Code, which require that GlaxoSmithKline 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, provide an explanation of how and why it does not comply (Listing Rule 9.8.6). In addition, GlaxoSmithKline is required to make certain mandatory corporate governance statements in the Directors’ Report in accordance with the UK Listing Authority’s Disclosure Guidance and Transparency Rules, DTR 7. GlaxoSmithKline will comply with these requirements in its 2021 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. | GlaxoSmithKline’s Code of Conduct for all employees, including the CEO, CFO and other senior financial officers, is available on GlaxoSmithKline’s website. | ||
Foreign Private Issuer Disclosure (303A.11 of the NYSE Manual) |
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| 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. | GlaxoSmithKline fulfils this requirement by including this disclosure in its Annual Report on Form 20-F. | ||
Certification Requirements (303A.12 of the NYSE Manual)[SG2] |
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| 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). | GlaxoSmithKline fulfils this requirement by filing the required certifications each year. | ||
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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 168; |
| • | “Consolidated statement of comprehensive income” on page 168; |
| • | “Consolidated balance sheet” on page 169; |
| • | “Consolidated statement of changes in equity” on page 170; |
| • | “Consolidated cash flow statement” on page 171; and |
| • | “Notes to the financial statements” on pages 172 to 251 |
of the GSK Annual Report 2021 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 GlaxoSmithKline plc
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of GlaxoSmithKline plc and subsidiaries (the “Group”) as at 31 December 2021 and 2020, 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 2021, and the related notes, included in Exhibit 15.2 on pages 168 to 251 (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 2021 and 2020, and the results of its operations and its cash flows for each of the three years in the period ended 31 December 2021, 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 2021, based on criteria established in issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated 8 March 2022, expressed an unqualified opinion on the Group’s internal control over financial reporting.
Internal Control — Integrated Framework (2013)
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.
Valuation of the ViiV Healthcare Shionogi contingent consideration liability
Accounts impacted: Contingent consideration liabilities and Other operating expense
Refer to Notes 3, 28, 32 and 43 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 2021 the liability was valued at £5,559 million.
We identified the ViiV CCL as a critical audit matter because of the significant management 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 treatmentsand 2-drug regimens, the continuing impact of COVID-19 related restrictions on HIV prescriptions and subsequent sales volumes and pricing. The forecasts also required significant audit effort to perform appropriate audit procedures to challenge and evaluate the reasonableness of those forecasts.
As set out in the Group financial statements in the Post Balance Sheet Events note, the agreement reached with Gilead to settle the global patent infringement litigation relating to commercialisation of Gilead’s Biktarvy increases the future consideration payable to Shionogi and therefore impacts the fair value of the ViiV CCL. As a result, in our audit we assessed management’s estimate of this impact.
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 evaluated their appropriateness, 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; |
| • | Evaluated 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 and expected changes in payer policy; |
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| • | 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 14 analysts and considered sales forecasts on both a total ViiV basis and an individual product basis, assessing against identified contradictory data; |
| • | Inspected the agreement with Gilead and evaluated management’s approach to ensure it meets relevant accounting standards requirements and that the inputs used in estimating the impact on the fair value of the ViiV CCL are consistent with the agreement and external 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. |
Valuation of US Returns and Rebates (RAR) accruals
Accounts impacted: Turnover and Trade and other payables
Refer to Notes 3 and 28 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 2021 $17,215 million of RAR deductions were made to gross revenue of $33,598 million, resulting in net revenue of $16,383 million. The balance sheet accrual at 31 December 2021 for the combined US Pharmaceuticals and Vaccines businesses amounted to $6,795 million.
The three 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 ongoing generic competition and the macroeconomic impacts from the COVID-19 pandemic; |
| • | 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; |
| • | Challenged 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. |
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 40 to the financial statements
Critical Audit Matter Description
As at 31 December 2021, the Group held £29,115 million of other intangible assets (including licences, patents, trademarks and brand names, but excluding goodwill and computer software). The recoverable amount of these other intangible assets relies on certain assumptions and estimates of future trading performance which create estimation uncertainty.
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The assets most at risk of material impairment were identified using sensitivity analysis on key assumptions and a review of potential triggering events that could be indicative of an impairment in the carrying value of associated assets. As a result of this analysis, we performed additional audit procedures on certain indefinite life Consumer Healthcare intangible assets.
Key assumptions applied in determining the recoverable amount include the future sales growth rates and profit margin levels, as well as the likelihood of successful new product innovations. Changes in these assumptions could lead to an impairment of the carrying value of the other intangible assets.
We identified the valuation of other intangible assets as a critical audit matter due to the inherent judgements involved in estimating future cash flows. During the year there was increased uncertainty brought about by the COVID-19 pandemic and associated lockdowns. Auditing such estimates required extensive audit effort to challenge and evaluate the reasonableness of forecasts.
How the Critical Audit Matter Was Addressed in the Audit
We performed the following audit procedures, amongst others, related to the future sales growth, likelihood of successful new product innovations and profit margin levels used in the assessment of other intangible assets for impairment:
| • | Met with the key individuals from the senior leadership team, product category leads and key personnel involved in the forecasting process to discuss and evaluate the Group’s evidence to support future sales growth rates and profitability assumptions; |
| • | Evaluated the Group’s risk assessment of the impact of climate change on long term forecasts by comparing to external data points which focused on the largest products with material carrying values and the least headroom. |
| • | Evaluated the business assumptions applied in estimating sales and gross profit margin forecasts, including benchmarking of forecasts against external market data and actual trading performance costs. This included independent market research of expected category growth and assessment of any sources of contradictory evidence; |
| • | Compared the forecast sales and gross profit margins to the Plan data (asset by asset internal forecasts) approved by the GSK Leadership Team and the Board of Directors; |
| • | Assessed the historical accuracy of forecasts including consumption data and estimates of new sales from innovation; |
| • | 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; 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 revenue growth rates and profit margins. |
Valuation of uncertain tax positions, including transfer pricing
Accounts impacted: Corporation tax payable, Deferred tax liabilities and Taxation charge
Refer to Notes 3 and 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 2021, 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. |
/s/ Deloitte LLP
London, United Kingdom
8 March 2022
The first accounting period we audited was 31 December 2018
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| Item 19 | Exhibits |
| * | 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 2021 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.
GlaxoSmithKline plc | ||||||
| March 8, 2022 | By: | /s/ Iain Mackay | ||||
| Iain Mackay | ||||||
| Chief Financial Officer | ||||||
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TABLE OF CONTENTS
Part IItem 1. Identity Of Directors, Senior Management and AdvisersItem 2. Offer Statistics and Expected TimetableItem 3. Key InformationItem 4. Information on The CompanyItem 4A. Unresolved Staff CommentsItem 5. Operating and Financial Review and ProspectsItem 6. Directors, Senior Management and EmployeesItem 7. Major Shareholders and Related Party TransactionsItem 8. Financial InformationItem 9. The Offer and ListingItem 10. Additional InformationItem 11. Quantitative and Qualitative Disclosures About Market RiskItem 12. Description Of Securities Other Than Equity SecuritiesPart IIItem 13. Defaults, Dividend Arrearages and DelinquenciesItem 14. Material Modifications To The Rights Of Security Holders and Use Of ProceedsItem 15. Controls and ProceduresItem 16. [reserved]Item 16A. Audit Committee Financial ExpertItem 16. B Code Of EthicsItem 16. C Principal Accountant Fees and ServicesItem 16. D Exemptions From The Listing Standards For Audit CommitteesItem 16. E Purchases Of Equity Securities By The Issuer and Affiliated PurchasersItem 16. F Change in Registrant S Certifying AccountantItem 16. G Corporate GovernanceItem 16. H Mine Safety DisclosureItem 16. I Disclosure Regarding Foreign Jurisdictions That Prevent InspectionsPart IIIItem 17 Financial StatementsItem 18 Financial StatementsItem 19 Exhibits