AstraZeneca(AZN) - 2023 Q4 - Annual Report

Strategic Report Chairman's Statement The Chairman's statement highlights strong financial and scientific progress, confidence in future growth, and strategic goals including launching 15 new medicines by 2030 and achieving carbon negativity - The full-year dividend for 2023 is $2.90 per share, consistent with the previous year[9] - The company has an ambitious goal to launch at least 15 new medicines between 2023 and 2030 and to become carbon negative[10] - AstraZeneca anticipates another year of strong growth in 2024, driven by the continued adoption of its medicines across various geographies[10] CEO's Review The CEO's review details strong 2023 growth, with total revenue reaching $45.8 billion (6% CER increase), significant pipeline progress including three new medicine approvals, and advancements in sustainability goals | Metric | 2023 Value | Growth (CER) | | :--- | :--- | :--- | | Total Revenue | $45.8 billion | 6% | | Total Revenue (ex-COVID) | $45.5 billion | 15% | | Oncology Revenue | - | 21% | | CVRM Revenue | - | 18% | | R&I Revenue | - | 10% | | Rare Disease Revenue | - | 12% | | V&I Revenue | - | -71% | - The company aims to launch at least 15 new molecular entities (NMEs) between 2023 and 2030, with three approved in 2023: Airsupra, Truqap, and Wainua[16] - AstraZeneca is increasing investment in new modalities such as cell therapy, gene therapy, and RNA therapies through internal R&D and strategic acquisitions like Gracell and Cellectis[17] - The company is on track with its Ambition Zero Carbon strategy to halve its entire value chain footprint by 2030 and become carbon negative for all residual emissions from 2030 onwards[17] Company Overview AstraZeneca is a global, science-led pharmaceutical company with a diversified portfolio across Oncology, BioPharmaceuticals, and Rare Disease, generating $45.8 billion in 2023 revenue and leveraging AI across operations | Category | Breakdown | | :--- | :--- | | Total Revenue by Therapy Area | Oncology 40%, BioPharmaceuticals 40%, Rare Disease 17%, Other 3% | | Total Revenue by Region | US 42%, Emerging Markets 26%, Europe 21%, Established RoW 11% | - The company's late-stage pipeline includes 17 new molecular entities (NMEs) and 123 projects in Phase II and III[26] - Artificial intelligence (AI) is being integrated across the business to transform R&D, enhance manufacturing and supply, and create new, more integrated healthcare systems[28][29] Market and Strategy The company's "Growth Through Innovation" strategy, targeting 15 new medicines by 2030 and carbon negativity, navigates a growing global pharmaceutical market, with performance tracked by key financial and pipeline KPIs | Region | 2023 Sales ($bn) | Growth vs 2022 | | :--- | :--- | :--- | | Global | 1,332 | 9.6% | | US | 678 | 11.5% | | Europe | 248 | 7.8% | | Emerging Markets | 299 | 8.0% | - The company's strategy is 'Growth Through Innovation', with a 2030 Bold Ambition to launch at least 15 new medicines and become carbon negative[48] | Key Performance Indicator | 2023 Result | | :--- | :--- | | Net cash flow from operating activities | $10.345 billion | | Reported EPS | $3.84 | | Core EPS | $7.26 | | Total Revenue | $45.811 billion | | Pipeline progression events | 30 | | Regulatory events (submissions/approvals) | 56 | Therapy Area Review This section reviews the strategy, market context, key products, and 2023 performance of AstraZeneca's primary therapy areas, highlighting strong growth in Oncology and Rare Disease, and mixed results in BioPharmaceuticals Oncology The Oncology division achieved $18.447 billion in 2023 total revenue, a 21% CER increase, driven by strong market penetration and pipeline advancements including new approvals and positive pivotal trial results | Metric | Value | | :--- | :--- | | 2023 Total Revenue | $18.447 billion | | Growth (Actual) | 19% | | Growth (CER) | 21% | | Product | 2023 Total Revenue ($bn) | Growth (CER) | | :--- | :--- | :--- | | Tagrisso | $5.799 | 9% | | Imfinzi | $4.237 | 55% | | Lynparza | $3.056 | 4% | | Calquence | $2.514 | 23% | | Enhertu | $1.283 | 114% | - Key pipeline achievements in 2023 include the first approval for Truqap (capivasertib) for breast cancer and nine positive Phase III trial readouts, including the first pivotal results for datopotamab deruxtecan (Dato-DXd)[59][65] BioPharmaceuticals The BioPharmaceuticals unit saw CVRM revenue grow 18% (CER) to $10.628 billion and R&I revenue increase 10% (CER) to $6.404 billion, while V&I revenue significantly declined 71% (CER) to $1.357 billion due to reduced COVID-19 medicine demand | Sub-Area | 2023 Total Revenue | Growth (CER) | | :--- | :--- | :--- | | Cardiovascular, Renal & Metabolism (CVRM) | $10.628 billion | +18% | | Respiratory & Immunology (R&I) | $6.404 billion | +10% | | Vaccines & Immune Therapies (V&I) | $1.357 billion | -71% | - CVRM growth was driven by Forxiga, which became the number one SGLT2 inhibitor worldwide by volume and expanded its label to a broader range of heart failure populations[71][75] - R&I growth was driven by key launch brands Breztri, Fasenra, Tezspire, and Saphnelo, which now represent approximately 50% of the total R&I portfolio[73] - The significant decline in V&I revenue was due to the end of pandemic-related contracts for COVID-19 medicines, with Vaxzevria sales dropping from $1.875 billion in 2022 to $12 million in 2023[89] Rare Disease The Rare Disease division, Alexion, generated $7.764 billion in 2023 revenue, a 12% CER increase, driven by Ultomiris conversion and strong product performance, while expanding into new disease areas and genomic medicine | Metric | Value | | :--- | :--- | | 2023 Total Revenue | $7.764 billion | | Growth (Actual) | 10% | | Growth (CER) | 12% | | Product | 2023 Total Revenue ($bn) | Growth (CER) | | :--- | :--- | :--- | | Soliris | $3.145 | -14% | | Ultomiris | $2.965 | +52% | | Strensiq | $1.152 | +21% | | Koselugo | $331 million | +60% | - Growth is driven by successful patient conversion from Soliris to Ultomiris across shared indications, with Ultomiris gaining approvals for new indications like NMOSD in the EU and Japan[99] - The division is expanding beyond complement therapies by advancing the industry's largest amyloidosis pipeline and accelerating its genomic medicine ambition through acquisitions, such as Pfizer's preclinical gene therapy portfolio[93][99][100] Business Review This section provides an operational overview of global functions, highlighting $10.9 billion R&D investment, $45.8 billion revenue from commercial operations, and progress in people and sustainability goals including 50.1% women in senior roles and 67.6% GHG emission reduction Science and Innovation (R&D) AstraZeneca's R&D invested $10.9 billion in 2023, resulting in three new medicine approvals, 56 regulatory events, and a pipeline of 178 projects, with a strategic focus on advanced therapeutics and AI-driven clinical trials - R&D investment in 2023 was $10.9 billion, a significant increase from $9.8 billion in 2022, with 60% directed towards late-stage development[109][111] | Pipeline Metric | 2023 Performance | | :--- | :--- | | NME Phase II starts/progressions | 6 | | NME and major LCM Phase III investment decisions | 24 | | NME and major LCM submissions | 31 | | NME and major LCM approvals | 25 | - The pipeline consists of 178 projects, with 160 in the clinical phase, and 17 NME projects in pivotal trials or under regulatory review[109][119] - The company is committed to the 3Rs (Replacement, Reduction, and Refinement) for animals in research, with over 97% of 122,768 in-house and 59,690 contract study animal uses being rodents or fish in 2023[115] Growth and Commercial Operations This section details $45.811 billion in total revenue, successful operational execution with 282 market launches, and over 20 strategic business development transactions aimed at bolstering the pipeline and leveraging AI | Region | 2023 Total Revenue ($bn) | Actual Growth % | | :--- | :--- | :--- | | US | $19.077 | 6% | | Emerging Markets | $12.025 | 2% | | Europe | $9.611 | 10% | | Established Rest of World | $5.099 | (14)% | | Total | $45.811 | 3% | - In China, AstraZeneca is the largest pharmaceutical company in the hospital sector, with 2023 revenue growing 7% at CER to $5.876 billion[133] - The Operations division delivered 282 successful market launches and maintained a supply performance of over 99%[123][15] - Over 20 major business development transactions were completed, including acquisitions to strengthen the pipeline in cardiorenal (CinCor), vaccines (Icosavax), cell therapy (Gracell), and a licensing deal for a GLP-1RA for obesity (Eccogene)[123][160] People and Sustainability AstraZeneca's People and Sustainability strategy achieved 86% employee engagement, 50.1% female representation in senior roles, reached 66.4 million people through access programs, and reduced Scope 1 & 2 GHG emissions by 67.6% since 2015 - The company employs 89,900 people, with 50.1% of senior middle management roles and above filled by women[107][163][166] - The company has reduced its Scope 1 and 2 GHG emissions by 67.6% from its 2015 baseline and is on track for its Ambition Zero Carbon targets[164][167][185] - Through its flagship access to healthcare programmes (e.g., Healthy Heart Africa, Young Health Programme), the company has cumulatively reached 66.4 million people[164][168][184] - The AZ Forest initiative commitment was increased to planting and stewarding 200 million trees by 2030, up from the previous goal of 50 million by 2025[164][185] EU Taxonomy and Climate Disclosures This section details EU Taxonomy disclosures, with 100% revenue eligibility but no full alignment, and outlines TCFD-aligned management of climate-related physical and transition risks through the Ambition Zero Carbon strategy | EU Taxonomy KPI | 2023 Eligibility % | | :--- | :--- | | Revenue | 100% | | Capex | 83% | | Opex | 99% | - No economic activities were assessed as fully Taxonomy-aligned in 2023[191] - Physical climate risks (e.g., extreme heat, flooding) have been screened across operations and strategic suppliers, while transition risks include new EU F-gas regulations, which could impact the company's pMDI inhaler portfolio, and carbon pricing uncertainty[201][207][209] - Climate-related risks are managed through the Ambition Zero Carbon strategy, which includes a transition to near-zero GWP propellants for inhalers, and are integrated into the Group's overall enterprise risk management framework[204][208] Risk Overview AstraZeneca's risk management framework identifies Principal Risks across pipeline, commercial, supply chain, legal, IP, and financial areas, with a Viability Statement confirming operational continuity through 2026 based on stress-tested business plans - Principal Risks are categorized as: Product pipeline, Commercialisation, Supply chain and business execution, Legal, regulatory and compliance, IP, and Economic and financial risks[225][234][241] - Key Principal Risks include: failure or delay in pipeline delivery, pricing and competitive pressures, failure to maintain supply of quality medicines, and failure in information technology or cybersecurity[226][234] - The company provides a Viability Statement confirming its ability to operate and meet liabilities over a three-year period to 31 December 2026, based on a detailed business plan and analysis of severe but plausible downside scenarios combining several Principal Risks[220][221][223] Financial Review The Financial Review highlights strong 2023 performance with $45.811 billion Total Revenue (up 6% CER) and $7.26 Core EPS (up 15% CER), driven by the non-COVID-19 portfolio, and provides 2024 guidance for low double-digit to low teens growth | Metric | 2023 Reported | 2023 Core | | :--- | :--- | :--- | | Total Revenue | $45.811 billion | $45.811 billion | | Operating Profit | $8.193 billion | $14.534 billion | | Profit Before Tax | $6.899 billion | $13.538 billion | | Basic EPS | $3.84 | $7.26 | - Excluding COVID-19 medicines, Total Revenue increased by 13% (15% at CER) in 2023[242] - Net debt at year-end was $22.51 billion, a slight decrease from $22.92 billion in 2022, with net cash generated from operating activities at $10.35 billion[270][276][281] - 2024 Guidance: Total Revenue is expected to increase by a low double-digit to low teens percentage, and Core EPS is also expected to increase by a low double-digit to low teens percentage[287] Corporate Governance Governance Overview and Board of Directors This section outlines AstraZeneca's governance structure, led by a diverse Board of Directors and its five committees, responsible for strategy, risk oversight, and ensuring long-term success - The Board comprises a Non-Executive Chair (Michel Demaré), two Executive Directors (Pascal Soriot, Aradhana Sarin), and ten Non-Executive Directors[300] - As of year-end 2023, the Board's composition includes 46% women and 31% who identify as an ethnic minority[300][354] - The Board delegates certain powers to the CEO and operates with the assistance of five committees: Audit, Science, Nomination and Governance, Remuneration, and Sustainability[298] Board and Committee Reports This section details the Board and committee activities, including compliance with the UK Corporate Governance Code, Board succession and diversity, R&D oversight, sustainability reporting, and financial reporting integrity Corporate Governance Report The report confirms compliance with the 2018 UK Corporate Governance Code, detailing the Board's role in promoting long-term success, stakeholder engagement, and multi-channel workforce engagement - The company confirms compliance with the 2018 UK Corporate Governance Code, except for a justified postponement of the externally-facilitated Board evaluation due to a change in Chair[314][347] - The Board engages with a wide range of stakeholders (investors, patients, HCPs, employees, governments) and considers their interests in its decision-making process, as detailed in the Section 172(1) statement[291][319][341] - The Board uses multiple mechanisms for workforce engagement, including global Pulse surveys with 92% participation, 'townhall' meetings, and site visits, believing this is more effective than a single designated workforce director[345] Nomination and Governance Committee Report The Nomination and Governance Committee manages Board composition, succession planning, and diversity, overseeing Chair transition, new director appointments, and ensuring diversity targets are met - The committee led the appointment process for new Non-Executive Director Anna Manz, who joined the Board and Audit Committee in September 2023[353] | Diversity Metric | Board Representation (as of 31 Dec 2023) | | :--- | :--- | | Women | 46% | | Ethnic Minority | 31% | - The committee is actively planning for Non-Executive Director succession, as four current directors will reach nine years' tenure by 2026[347] Science Committee Report The Science Committee assures the Board on R&D quality and competitiveness, reviewing strategy, key science platforms, and the scientific rationale for significant business development activities - The committee's core role is to provide assurance to the Board on the quality, competitiveness, and integrity of the Group's R&D activities[366] - In 2023, the committee reviewed the R&D strategy, key science capabilities including AI, and the scientific case for major acquisitions and licensing deals such as CinCor Pharma, Neogene Therapeutics, and a gene therapy portfolio from Pfizer[366] Sustainability Committee Report The Sustainability Committee oversees the company's sustainability strategy, disclosures, and performance, focusing on new reporting regulations, health equity, and ESG target review - The committee's key responsibilities include overseeing the execution of the sustainability strategy, monitoring related disclosures, and advising the Board on sustainability matters[368] - Key focus areas in 2023 included preparing for new sustainability reporting standards (e.g., CSRD), establishing a health equity strategy, and overseeing the CSRD double materiality assessment[368] Audit Committee Report The Audit Committee monitors financial reporting integrity, internal controls, and risk management, addressing significant issues like intangible asset valuation, revenue recognition, litigation provisions, and overseeing the external audit process - Significant financial reporting issues considered in 2023 were: valuation of intangible assets (impairments of $434 million), revenue recognition (especially US gross-to-net deductions), litigation provisions ($1.020 billion recorded for three proceedings), and tax liabilities[379][384][385][386] - The committee oversees cybersecurity risk, which is identified as a Principal Risk, and receives regular reports on the company's mitigation strategies[373] - The committee concluded that the 2023 audit by PwC was effective and recommended their reappointment for 2024, with a competitive tender process for the external audit to be conducted in 2024 for the 2027 financial year[392][393] Directors' Remuneration Report This report details the Executive Directors' remuneration policy and outcomes, linking pay to strong performance, with a new 2024 policy proposed to enhance competitiveness and align with shareholder interests through increased performance-related pay opportunities | Executive Director | 2023 Realised Pay (Single Total Figure) | | :--- | :--- | | Pascal Soriot (CEO) | £16.853 million | | Aradhana Sarin (CFO) | £4.410 million | - The 2023 annual bonus was awarded at 79.5% of maximum for Executive Directors, in line with the Group scorecard outcome which measures performance across science, financials, and ESG[411][457] - The 2021-2023 Performance Share Plan (PSP) vested at 88% of maximum, reflecting strong performance in science, financials (Total Revenue, Cash Flow, Core EPS), relative TSR, and Ambition Zero Carbon targets[414][419] - A new Remuneration Policy is proposed for 2024 to increase competitiveness, including raising the CEO's maximum PSP opportunity to 850% of base pay (from 650%) and maximum bonus to 300% of base pay (from 250%), with increased shareholding requirements[421][422] Financial Statements This section presents the audited consolidated financial statements for 2023, prepared under UK-adopted IAS and IFRS, including comprehensive income, financial position, equity changes, cash flows, and detailed accounting policies and notes - The financial statements have been prepared in accordance with UK-adopted IAS and also comply fully with IFRS Accounting Standards as issued by the IASB[253][288] - The section includes the Consolidated Financial Statements, Group Accounting Policies, Notes to the Group Financial Statements (1-31), a list of Group Subsidiaries, and the separate Company Financial Statements and related notes[7] - The Directors' Annual Report on Internal Controls over Financial Reporting confirms management's responsibility for establishing and maintaining adequate internal control over financial reporting, as required by the Sarbanes-Oxley Act[7][288] Additional Information This section provides supplementary information including shareholder details, the Directors' Report, sustainability data, trademarks, a glossary of key terms, and a cautionary statement on forward-looking statements - This section contains practical shareholder information, the formal Directors' Report, and supplementary sustainability data[8] - A glossary is provided to define key terms and acronyms used in the report, such as CER (Constant Exchange Rate), NME (New Molecular Entity), and various therapy area abbreviations[8] - The report concludes with a cautionary statement regarding forward-looking statements, highlighting the inherent risks and uncertainties in the pharmaceutical industry that could cause actual results to differ from projections[8]