AstraZeneca PLC (NASDAQ:AZN) Q2 2023 Earnings Conference Call July 28, 2023 6:45 AM ET Company Participants Andy Barnett - Head, Investor Relations Pascal Soriot - Chief Executive Officer Aradhana Sarin - Chief Financial Officer David Fredrickson - Executive Vice-President, Oncology Business Unit Susan Galbraith - Executive Vice President, Oncology Research & Development Ruud Dobber - EVP of BioPharmaceuticals Business Unit Mene Pangalos - Executive Vice-President, BioPharmaceuticals R&D Marc Dunoyer - Chie ...

H1 and Q2 2023 Results Conference call and webcast for investors and analysts Forward-looking statements In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act of 1995, AstraZene ...

[Performance Overview](index=2&type=section&id=H1%20and%20Q2%202023%20results) [Financial Performance Summary](index=2&type=section&id=Financial%20performance) H1 2023 total revenue grew 4% to **$22.295 billion** (CER), with Core EPS up 21% to **$4.07**, driven by non-COVID-19 therapeutic areas | Metric | H1 2023 | YoY Change (CER) | Q2 2023 | YoY Change (CER) | | :--- | :--- | :--- | :--- | :--- | | **Total Revenue** | $22.295 billion | +4% | $11.416 billion | +9% | | **Total Revenue (excluding COVID-19 medicines)** | $21.961 billion | +16% | $11.237 billion | +17% | | **Reported EPS** | $2.34 | >6 times | $1.17 | >9 times | | **Core EPS** | $4.07 | +21% | $2.15 | +38% | - All non-COVID-19 therapeutic areas achieved double-digit revenue growth: Oncology grew 22%, Cardiovascular, Renal & Metabolism (CVRM) grew 20%, Respiratory & Immunology (R&I) grew 10%, and Rare Disease grew 12%[4](index=4&type=chunk) - Core product sales gross margin increased by three percentage points to **83%**, primarily due to decreased sales of lower-margin COVID-19 medicines and a continued shift in product mix towards specialty medicines[4](index=4&type=chunk) - Eight medicines generated over **$1 billion** in revenue in H1, with Ultomiris, Imfinzi/Imjudo, and Farxiga revenues growing 64%, 57%, and 40% respectively[5](index=5&type=chunk) [Full-Year Guidance](index=3&type=section&id=Guidance) The company reaffirms FY2023 guidance for total revenue and Core EPS growth, with an upward revision for China revenue growth, excluding COVID-19 medicines | Guidance Item | FY2023 Outlook (CER) | | :--- | :--- | | **Total Revenue Growth** | Low to mid-single-digit percentage | | **Total Revenue Growth (excluding COVID-19 medicines)** | Low double-digit percentage | | **Core EPS Growth** | High single-digit to low double-digit percentage | | **China Total Revenue Growth** | Low to mid-single-digit percentage (previously low single-digit) | | **Core Operating Expense Growth** | Low to mid-single-digit percentage | - Total revenue from COVID-19 medicines (Vaxzevria and COVID-19 mAbs) is expected to decline significantly in FY2023[7](index=7&type=chunk) - Assuming average exchange rates from June 2023, total revenue is expected to be adversely impacted by a low single-digit percentage, and Core EPS by a low to mid-single-digit percentage in FY2023[7](index=7&type=chunk) [Key Milestones and Sustainability](index=2&type=section&id=Key%20milestones) The company achieved significant R&D and regulatory milestones, including positive trial data for datopotamab deruxtecan and key approvals for Lynparza and Farxiga, while committing an additional **$400 million** to the AZ Forest program - Positive R&D pipeline progress includes key trial results for datopotamab deruxtecan (TROPION-Lung01), Tagrisso (FLAURA2), and Lynparza + Imfinzi (DUO-E)[5](index=5&type=chunk)[10](index=10&type=chunk) - Multiple important regulatory approvals were secured, such as Lynparza in the US for BRCA-mutated prostate cancer, Farxiga in the US for heart failure with preserved ejection fraction, and Enhertu in China for HER2-low breast cancer[6](index=6&type=chunk)[10](index=10&type=chunk) - As part of its "Ambition Zero Carbon" sustainability plan, the company announced a **$400 million** investment in the AZ Forest program, committing to plant **200 million** trees by 2030[5](index=5&type=chunk)[17](index=17&type=chunk) [Operating and Financial Review](index=11&type=section&id=Operating%20and%20financial%20review) [Total Revenue Analysis](index=13&type=section&id=Total%20Revenue) H1 2023 total revenue reached **$22.295 billion**, growing 4% (CER), with Oncology, Rare Disease, and CVRM as key drivers, and strong performance in the US and Emerging Markets | Revenue Type (H1 2023) | Amount (billion USD) | Share | YoY Change (CER) | | :--- | :--- | :--- | :--- | | **Product Sales** | $21.448 | 96% | +3% | | **Alliance Revenue** | $0.627 | 3% | >2 times | | **Collaboration Revenue** | $0.220 | 1% | -15% | | **Total Revenue** | **$22.295** | **100%** | **+4%** | | Therapeutic Area (H1 2023) | Amount (billion USD) | Share | YoY Change (CER) | | :--- | :--- | :--- | :--- | | **Oncology** | $8.794 | 39% | +22% | | **BioPharmaceuticals** | $9.051 | 41% | -9% | | - CVRM | $5.239 | 24% | +20% | | - R&I | $3.180 | 14% | +10% | | - V&I | $0.632 | 3% | -76% | | **Rare Disease** | $3.819 | 17% | +12% | | **Other Medicines** | $0.631 | 3% | -22% | | Region (H1 2023, excluding COVID-19 medicines) | Amount (billion USD) | Share | YoY Change (CER) | | :--- | :--- | :--- | :--- | | **US** | $9.081 | 41% | +16% | | **Emerging Markets** | $6.074 | 28% | +22% | | - China | $3.043 | 14% | +9% | | - Emerging Markets (excluding China) | $3.031 | 14% | +38% | | **Europe** | $4.356 | 20% | +13% | | **Established Rest of World** | $2.450 | 11% | +8% | [Oncology Business](index=15&type=section&id=Oncology) H1 2023 Oncology revenue grew 22% (CER) to **$8.794 billion**, driven by strong performance of Imfinzi, Enhertu, and Calquence, with Tagrisso maintaining steady growth | Key Oncology Medicine (H1 2023) | Total Revenue (billion USD) | YoY Change (CER) | Key Drivers | | :--- | :--- | :--- | :--- | | **Tagrisso** | $2.915 | +12% | Increased global demand in adjuvant and first-line settings | | **Imfinzi** | $1.976 | +57% | Successful launches in new indications like hepatocellular carcinoma (HCC) and biliary tract cancer (BTC) | | **Lynparza** | $1.368 | -4% | Impacted by a $175 million milestone payment in the prior year, product sales grew 10% | | **Enhertu (Alliance Revenue)** | $0.475 | >2 times | Rapid adoption as a new standard of care in indications like HER2-low breast cancer | | **Calquence** | $1.185 | +33% | Increased global penetration, becoming a leading BTK inhibitor in key markets | [BioPharmaceuticals Business](index=18&type=section&id=BioPharmaceuticals) H1 2023 BioPharmaceuticals revenue decreased 9% (CER) to **$9.051 billion**, primarily due to a significant reduction in COVID-19 medicine sales, while CVRM and R&I showed robust growth [Cardiovascular, Renal & Metabolism (CVRM)](index=18&type=section&id=BioPharmaceuticals%20%E2%80%93%20CVRM) CVRM business H1 revenue reached **$5.239 billion**, growing 20% (CER), with Farxiga as the main growth engine due to strong demand in heart failure and chronic kidney disease indications | CVRM Key Medicine (H1 2023) | Total Revenue (billion USD) | YoY Change (CER) | | :--- | :--- | :--- | | **Farxiga** | $2.834 | +40% | | **Brilinta** | $0.665 | +1% | | **Lokelma** | $0.198 | +59% | | **Roxadustat** | $0.137 | +57% | [Respiratory & Immunology (R&I)](index=20&type=section&id=BioPharmaceuticals%20%E2%80%93%20R%26I) R&I business H1 revenue was **$3.180 billion**, growing 10% (CER), driven by new products like Fasenra, Breztri, Saphnelo, and Tezspire, with Symbicort showing stable performance | R&I Key Medicine (H1 2023) | Total Revenue (billion USD) | YoY Change (CER) | | :--- | :--- | :--- | | **Symbicort** | $1.288 | +4% | | **Fasenra** | $0.744 | +14% | | **Breztri** | $0.307 | +76% | | **Saphnelo** | $0.115 | >3 times | | **Tezspire (Alliance Revenue)** | $0.105 | >6 times | [Vaccines & Immune Therapies (V&I)](index=22&type=section&id=BioPharmaceuticals%20%E2%80%93%20V%26I) H1 2023 V&I revenue significantly declined 76% (CER) to **$632 million**, mainly due to the conclusion of COVID-19 vaccine contracts and reduced demand for COVID-19 antibodies - Total revenue from COVID-19 monoclonal antibodies (mAbs) was **$306 million**, a 65% decrease (CER) year-on-year, with all product sales from Evusheld in Q1, and a **$180 million** license fee from Serum Institute of India (SII) in Q2[57](index=57&type=chunk) - COVID-19 vaccine (Vaxzevria) revenue was **$28 million**, a 98% decrease (CER) year-on-year due to contract conclusion[57](index=57&type=chunk) [Rare Disease Business](index=23&type=section&id=Rare%20Disease) H1 2023 Rare Disease revenue grew 12% (CER) to **$3.819 billion**, driven by C5 inhibitor products and strong patient demand for Strensiq, with Ultomiris showing significant growth | Rare Disease Key Medicine (H1 2023) | Total Revenue (billion USD) | YoY Change (CER) | Key Drivers | | :--- | :--- | :--- | :--- | | **Ultomiris** | $1.364 | +64% | Expansion in neurological indications and new markets, and continued conversion from Soliris | | **Soliris** | $1.648 | -16% | Impacted by successful conversion to Ultomiris | | **Strensiq** | $0.562 | +26% | Strong patient demand and geographical expansion | | **Koselugo** | $0.159 | +57% | Expansion in new markets | [Financial Performance Analysis](index=25&type=section&id=Financial%20performance) [Profit and Loss Analysis](index=25&type=section&id=Profit%20and%20Loss) H1 2023 reported operating profit significantly increased to **$5.005 billion**, with gross margin improving due to reduced low-margin COVID-19 products and a **$712 million** Beyfortus contract gain | P&L Item (H1 2023) | Amount (billion USD) | YoY Change (CER) | | :--- | :--- | :--- | | **Total Revenue** | $22.295 | +4% | | **Gross Profit** | $18.430 | +24% | | **Product Sales Gross Margin** | 82.0% | +13 percentage points | | **R&D Expenses** | $5.278 | +16% | | **SG&A Expenses** | $9.045 | -2% | | **Other Operating Income** | $1.163 | >5 times | | **Operating Profit** | $5.005 | >4 times | | **Profit Before Tax** | $4.350 | >6 times | | **Net Profit** | $3.624 | >6 times | - Gross margin improvement was driven by an increased proportion of high-margin Oncology and Rare Disease medicines, and a significant decline in low-margin Vaxzevria sales[68](index=68&type=chunk) - Other operating income includes a **$712 million** gain from an updated contractual relationship for Beyfortus[71](index=71&type=chunk) - Reported SG&A expenses were impacted by a **$510 million** provision related to legal settlements with Bristol Myers Squibb (BMS) and Ono[70](index=70&type=chunk) [Cash Flow and Net Debt](index=30&type=section&id=Cash%20Flow%20and%20Net%20Debt) H1 2023 net cash from operating activities was **$4.851 billion**, while net debt increased to **$23.970 billion** due to intangible asset acquisitions and dividend payments | Cash Flow Statement Item (H1 2023) | Amount (billion USD) | | :--- | :--- | | **Net cash generated from operating activities** | $4.851 | | **Net cash used in investing activities** | ($1.766) | | **Net cash used in financing activities** | ($3.550) | - Increased cash outflow from investing activities was primarily due to intangible asset purchases, including the acquisition of CinCor for **$1.436 billion**[76](index=76&type=chunk) | Net Debt Composition | June 30, 2023 (billion USD) | December 31, 2022 (billion USD) | | :--- | :--- | :--- | | **Cash and Investments** | $5.812 | $6.405 | | **Total Debt** | ($29.838) | ($29.232) | | **Net Derivative Financial Instruments** | $0.056 | ($0.096) | | **Net Debt** | **($23.970)** | **($22.923)** | [Principal Risks and Uncertainties](index=33&type=section&id=Principal%20risks%20and%20uncertainties) The company's principal risks remain consistent with the 2022 annual report, covering product pipeline, commercialization, supply chain, legal compliance, and macroeconomic factors - **Product Pipeline Risk**: Failure or delay in new drug development or launch; failure to meet regulatory or ethical requirements[92](index=92&type=chunk) - **Commercialization Risk**: Pricing, affordability, market access, and competitive pressures; failure or delay in commercial strategy execution[92](index=92&type=chunk) - **Supply Chain and Execution Risk**: Failure to maintain compliant, high-quality medicine supply; IT or cybersecurity failures; failure to attract and retain talent[93](index=93&type=chunk) - **Legal and Compliance Risk**: Safety or efficacy of marketed medicines questioned; adverse outcomes from litigation or government investigations; product-related intellectual property risks[93](index=93&type=chunk) - **Economic and Financial Risk**: Failure to achieve strategic plans or targets; geopolitical and macroeconomic volatility disrupting global operations[93](index=93&type=chunk) [Sustainability](index=34&type=section&id=Sustainability) [Sustainability Summary](index=34&type=section&id=Sustainability%20Summary) The company made significant progress in sustainability, focusing on healthcare access, environmental protection, and ethics, including expanding health programs and investing **$400 million** in the AZ Forest project - **Healthcare Access**: The "Healthy Heart Africa" (HHA) program has conducted over **38.5 million** blood pressure screenings since its 2014 launch, and the "Young Health Programme" (YHP) has educated over **10 million** young people on non-communicable disease risks[94](index=94&type=chunk) - **Environmental Protection**: Announced expansion of the AZ Forest program with an increased investment of **$400 million**, aiming to plant **200 million** trees by 2030, and partnered with Vanguard Renewables to decarbonize all US R&D and manufacturing sites by end of 2026 using renewable natural gas[95](index=95&type=chunk) - **Ethics and Transparency**: Hosted internal discussions on clinical trial diversity and conducted employee events like "World Day for Cultural Diversity" and "Pride Month" to foster cultural intelligence and inclusivity[97](index=97&type=chunk) [Research and Development Progress](index=36&type=section&id=Research%20and%20development) [R&D Highlights](index=36&type=section&id=R%26D%20Highlights) R&D pipeline achieved major breakthroughs, including positive trial results for datopotamab deruxtecan and Tagrisso, and key US approvals for Farxiga and Beyfortus, while some projects were terminated - **Datopotamab deruxtecan (Dato-DXd)**: The TROPION-Lung01 Phase III trial met one of its dual primary endpoints, showing statistically significant improvement in progression-free survival (PFS) compared to docetaxel in previously treated advanced NSCLC patients[106](index=106&type=chunk) - **Tagrisso**: The FLAURA2 Phase III trial met its primary endpoint, demonstrating significantly improved PFS for advanced EGFRm NSCLC patients when Tagrisso is combined with chemotherapy compared to monotherapy[101](index=101&type=chunk) - **Farxiga**: Approved in the US to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult heart failure patients, regardless of left ventricular ejection fraction[107](index=107&type=chunk) - **Beyfortus**: Approved in the US for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season[113](index=113&type=chunk) - **Project Terminations**: Clinical development of brazikumab in inflammatory bowel disease (IBD) was terminated, as was the Phase III trial of Fasenra in bullous pemphigoid due to futility[110](index=110&type=chunk)[111](index=111&type=chunk) [Interim Financial Statements](index=42&type=section&id=Interim%20Financial%20Statements) [Financial Statements](index=42&type=section&id=Financial%20Statements) This section presents the unaudited condensed consolidated interim financial statements for H1 2023, prepared in accordance with IAS 34 | Statement Name | Corresponding Table | Page Number | | :--- | :--- | :--- | | Condensed Consolidated Statement of Comprehensive Income (H1 2023) | Table 20 | 42 | | Condensed Consolidated Statement of Comprehensive Income (Q2 2023) | Table 21 | 43 | | Condensed Consolidated Statement of Financial Position | Table 22 | 44 | | Condensed Consolidated Statement of Changes in Equity | Table 23 | 45 | | Condensed Consolidated Statement of Cash Flows | Table 24 | 46 | [Notes to the Interim Financial Statements](index=50&type=section&id=Notes%20to%20the%20Interim%20Financial%20Statements) [Note 1: Basis of preparation and accounting policies](index=50&type=section&id=Note%201%3A%20Basis%20of%20preparation%20and%20accounting%20policies) Financial statements are prepared under IAS 34, with updated revenue presentation from January 1, 2023, now separately reporting Alliance Revenue to reflect recurring profit-sharing - Effective January 1, 2023, total revenue is disaggregated into Product Sales, Alliance Revenue, and Collaboration Revenue, with Alliance Revenue primarily comprising profit shares, revenue shares, or royalties related to sales with partners[137](index=137&type=chunk) - The Board continues to prepare financial statements on a going concern basis, as the company has sufficient financial resources, including **$5.7 billion** in cash and **$6.9 billion** in undrawn committed bank facilities[139](index=139&type=chunk)[140](index=140&type=chunk) [Note 6: Legal proceedings and contingent liabilities](index=55&type=section&id=Note%206%3A%20Legal%20proceedings%20and%20contingent%20liabilities) The company updated on significant legal proceedings, including a global settlement with BMS and Ono for Imfinzi/Imjudo patents, with a **$510 million** provision, and ongoing product liability lawsuits for Onglyza and Nexium - **Imfinzi and Imjudo Patent Litigation**: The company reached a global settlement agreement with BMS and Ono in July 2023, resolving all related patent disputes, and a **$510 million** provision was recognized[162](index=162&type=chunk) - **Onglyza Product Liability Litigation**: In the US, lawsuits regarding Onglyza and Kombiglyze causing heart failure are ongoing, with a federal court's summary judgment in AstraZeneca's favor currently under appeal by plaintiffs[165](index=165&type=chunk)[178](index=178&type=chunk) - **Nexium and Prilosec Product Liability Litigation**: In the US, the company continues to face numerous lawsuits alleging proton pump inhibitors (PPIs) cause kidney injury and gastric cancer, with the first bellwether trial scheduled for October 2023[176](index=176&type=chunk) [Note 7: Subsequent events](index=60&type=section&id=Note%207%3A%20Subsequent%20events) Post-period, Alexion agreed to acquire and license Pfizer's early-stage rare disease gene therapy portfolio for up to **$1 billion** plus tiered sales royalties - In July 2023, Alexion reached an agreement with Pfizer to acquire its early-stage rare disease gene therapy portfolio for up to **$1 billion** plus tiered sales royalties, with the transaction expected to close in Q3 2023[187](index=187&type=chunk)

AstraZeneca @ ASCO 2023 Speakers and panelists THERAPEUTIC AREA LEADERSHIP Leora Horn, KEY EXTERNAL EXPERT Dave Fredrickson, Dr Roy Herbst, Global Clinical Head, Executive Vice President Lung Cancer and Lung Cancer Strategy Deputy Director, Yale Cancer Center Oncology Business Sunil Verma, Ingrid Mayer, Pascal Soriot, Global Head of Oncology, Global Clinical Strategy Head, Chief Executive Officer Medical Breast Cancer Osama Rahma, Susan Galbraith, Global Clinical Strategy Head, ...

AstraZeneca PLC (NASDAQ:AZN) ASCO Investor Event June 5, 2023 7:00 PM ET CorporateParticipants Andy Barnett - VP Global Head of IR Roy Herbst - Deputy Director, Yale Cancer Center Pascal Soriot - Chief Executive Officer Susan Galbraith - Executive Vice President Oncology R&D Dave Fredrickson - Executive Vice President Oncology Business Sunil Verma - Global Head of Oncology, Medical Leora Horn - Global Clinical Head, Lung Cancer and Lung Cancer Strategy Osama Rahma - Global Clinical Strategy Head, GI Cancer ...

AstraZeneca at #AACR23 Highlights from key programmes presented at the American Association for Cancer Research (AACR) Annual Meeting 2023 14–19 April 2023 For distribution to, and usage with, financial/investment analysts and investors only Oncology at AstraZeneca We have the vision to redefine cancer care and, “It’s exciting to see our one day, eliminate cancer as a cause of death. strategy to attack cancer ...

AstraZeneca PLC (NASDAQ:AZN) Q1 2023 Earnings Conference Call April 26, 2023 6:45 AM ET Company Participants Andy Barnett - VP Global Head of IR Pascal Soriot - CEO Aradhana Sarin - CFO Dave Fredrickson - EVP of Oncology Business Unit Susan Galbraith - EVP of Oncology Research & Development Ruud Dobber - EVP of BioPharmaceuticals Business Unit Mene Pangalos - EVP of BioPharmaceuticals R&D Iskra Reic Marc Dunoyer - CEO of Alexion & Chief Strategy Officer Leon Wang - EVP of International & China President C ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 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 19 ...

Strategic Report [Financial Highlights](index=3&type=section&id=Financial%20highlights) AstraZeneca reported strong 2022 financial growth, with Total Revenue increasing 19% to $44.4 billion, Core Operating Profit growing 34% to $13.4 billion, and net cash flow from operating activities rising 64% to $9.8 billion 2022 Key Financial Metrics | Metric | 2022 Value ($) | 2021 Value ($) | Growth (Actual) | Growth (CER) | | :--- | :--- | :--- | :--- | :--- | | **Total Revenue** | $44,351 million | $37,417 million | 19% | 25% | | **Reported Operating Profit** | $3,757 million | $1,056 million | 256% | 298% | | **Core Operating Profit** | $13,350 million | $9,928 million | 34% | 42% | | **Reported EPS** | $2.12 | $0.08 | 2,581% | 4,903% | | **Core EPS** | $6.66 | $5.29 | 26% | 33% | | **Net Cash Flow from Operating Activities** | $9,808 million | $5,963 million | 64% | N/A | [AstraZeneca at a Glance](index=4&type=section&id=AstraZeneca%20at%20a%20Glance) AstraZeneca is a science-led pharmaceutical company focused on Oncology, BioPharmaceuticals, and Rare Disease, with a 2022 development pipeline of 179 projects, total revenue of $44.4 billion, and a global workforce of 83,500 2022 Revenue Breakdown | Breakdown by Therapy Area | Percentage | Breakdown by Region | Percentage | | :--- | :--- | :--- | :--- | | Oncology | 35% | US | 40% | | BioPharmaceuticals | 45% | Emerging Markets | 26% | | Rare Disease | 16% | Europe | 20% | | Other Medicines | 4% | Established Rest of World | 13% | - The company's R&D pipeline consists of 179 projects, including 15 NMEs in late-stage pipeline and 121 NME or major life-cycle management projects in Phase II and III[18](index=18&type=chunk) - AstraZeneca employed **83,500 people** in 2022, an increase from 83,100 in 2021, with **49.5% of senior roles** filled by women[26](index=26&type=chunk) [Chair's Statement](index=6&type=section&id=Chair%27s%20Statement) Chair Leif Johansson reflects on a decade of growth, noting Total Revenue doubled to over $44 billion since 2018, 20 new medicines launched, and a 467% Total Shareholder Return, while announcing a $2.90 per share dividend and his retirement - Total Revenue doubled to over **$44 billion** in 2022 since the company returned to growth after 2018[30](index=30&type=chunk) - The Board declared a full-year dividend of **$2.90 per share** for 2022, an increase from $2.87 in 2021[29](index=29&type=chunk)[30](index=30&type=chunk) - Over the last decade, AstraZeneca delivered a Total Shareholder Return (TSR) of **467%**, significantly outperforming the FTSE100 (85%) and pharma peers (366%)[30](index=30&type=chunk) - The company launched **20 new medicines** in the last 10 years, including three in 2022, and had **14 blockbuster medicines** in 2022[31](index=31&type=chunk) [Chief Executive Officer's Review](index=7&type=section&id=Chief%20Executive%20Officer%27s%20Review) CEO Pascal Soriot reported strong 2022 performance with Total Revenue up 19% to $44.4 billion, significant R&D progress including 72 regulatory events and three new medicine approvals, and a 59% reduction in Scope 1 and 2 GHG emissions 2022 Total Revenue Growth by Therapy Area (CER) | Therapy Area | Growth (CER) | | :--- | :--- | | Oncology | 20% | | Cardiovascular, Renal & Metabolism | 19% | | Respiratory & Immunology | 3% | | Rare Disease | 10% | - The company achieved **72 regulatory submissions or approvals** and **29 pipeline progression events** in 2022[37](index=37&type=chunk) - Three new medicines were approved in 2022: Imjudo (liver and lung cancer), Beyfortus (RSV prevention in infants), and Airsupra (asthma)[37](index=37&type=chunk) - AstraZeneca achieved a **59% reduction** in Scope 1 and 2 greenhouse gas emissions by the end of 2022 compared to its 2015 baseline[38](index=38&type=chunk) [Healthcare in a Changing World](index=9&type=section&id=Healthcare%20in%20a%20Changing%20World) The global pharmaceutical sector saw 8.4% sales growth in 2022, with the US market accounting for nearly 50% of global sales, while facing key trends like geopolitical conflict, economic downturns, chronic disease burden, AI adoption, and climate change - Global pharmaceutical sales grew by **8.4%** in 2022, reaching **$1,214 billion**, with the US market growing by 8.8% to **$605 billion**[40](index=40&type=chunk)[41](index=41&type=chunk)[42](index=42&type=chunk) - Key global trends affecting the pharmaceutical sector include geopolitical conflict, global economic downturn, the rising prevalence of chronic diseases, the transformational impact of AI, and accelerating climate change[48](index=48&type=chunk)[50](index=50&type=chunk) - Investment in AI-enabled drug discovery surpassed **$5.2 billion** at the end of 2021, more than doubling in the past five years[50](index=50&type=chunk) [Our Purpose, Values and Business Model](index=12&type=section&id=Our%20Purpose%2C%20Values%20and%20Business%20Model) AstraZeneca's purpose is to "push the boundaries of science to deliver life-changing medicines," guided by five core values and a business model centered on science-led R&D investment, revenue generation from product sales, and reinvestment for long-term value - The company's purpose is to push the boundaries of science to deliver life-changing medicines[51](index=51&type=chunk) - In 2022, AstraZeneca invested **$9.8 billion** in science and generated **$9.8 billion** in net cash flow from operating activities[53](index=53&type=chunk) - The business model follows the life-cycle of a medicine: Investment (discovery, development), Revenue Generation (sales, collaborations), and Reinvestment (funding future innovation)[55](index=55&type=chunk)[56](index=56&type=chunk)[57](index=57&type=chunk) [Our Strategy and Key Performance Indicators](index=14&type=section&id=Our%20Strategy%20and%20Key%20Performance%20Indicators) AstraZeneca's strategy focuses on Science and Innovation, Growth and Therapy Area Leadership, and People and Sustainability, with an ambition to launch 15 new medicines by 2030, supported by strong 2022 KPI results including 29 pipeline progression events and 19% Total Revenue growth - The company's ambition is to launch **15 new medicines** by 2030[61](index=61&type=chunk) Key Performance Indicators (2022 vs 2021) | KPI Category | Metric | 2022 Result ($) | 2021 Result ($) | | :--- | :--- | :--- | :--- | | **Science & Innovation** | Pipeline Progression Events | 29 | 32 | | | Regulatory Events | 72 | 49 | | **Growth & Therapy Area Leadership** | Total Revenue | $44.4 billion | $37.4 billion | | **Financial Targets** | Core EPS | $6.66 | $5.29 | | **People & Sustainability** | Employee belief 'great place to work' | 86% | 85% | | | Sustainability Scorecard Performance | 7/9 Green | 10/12 Green | [Therapy Area Review](index=18&type=section&id=Therapy%20Area%20Review) AstraZeneca's 2022 revenue was driven by its core therapy areas, with Oncology growing 15% to $15.5 billion, BioPharmaceuticals generating $20.0 billion, and Rare Disease contributing $7.1 billion, led by key products like Tagrisso, Farxiga, and Ultomiris [Oncology](index=18&type=section&id=Oncology) The Oncology division achieved $15.5 billion in revenue in 2022, a 15% increase, driven by key products like Tagrisso, Lynparza, Imfinzi, and Calquence, with a strategy focused on scientific platforms and leadership in lung, breast, and blood cancers Key Oncology Product Revenue 2022 | Product | 2022 Revenue ($) | Growth (Actual) | Growth (CER) | | :--- | :--- | :--- | :--- | | Tagrisso | $5,444 million | 9% | 15% | | Lynparza | $2,993 million | 9% | 14% | | Imfinzi | $2,784 million | 15% | 21% | | Calquence | $2,057 million | 66% | 69% | | Enhertu | $602 million | 182% | 184% | - The Oncology strategy focuses on six scientific platforms: Tumour drivers and resistance, DNA damage response, Antibody drug conjugates (ADCs), Epigenetics, Immuno-oncology, and Cell therapies[88](index=88&type=chunk) [BioPharmaceuticals](index=22&type=section&id=BioPharmaceuticals) The BioPharmaceuticals unit, comprising CVRM, R&I, and V&I, aims to transform care for chronic diseases, with 2022 revenues of $9.2 billion for CVRM, $6.0 billion for R&I, and $4.8 billion for V&I, supported by positive trial results and new approvals BioPharmaceuticals Revenue 2022 | Business Unit | 2022 Revenue ($) | Growth (Actual) | Growth (CER) | | :--- | :--- | :--- | :--- | | CVRM | $9,211 million | 13% | 19% | | R&I | $5,963 million | -1% | 3% | | V&I | $4,836 million | 1% | 8% | [Rare Disease](index=30&type=section&id=Rare%20Disease) The Rare Disease unit generated $7.05 billion in revenue in its first full year, a 4% pro forma increase, driven by the C5 complement inhibitors Soliris and Ultomiris, with a strategy to maintain leadership in complement therapies and diversify the portfolio Key Rare Disease Product Revenue 2022 (Pro Forma) | Product | 2022 Revenue ($) | Growth (CER) | | :--- | :--- | :--- | | Soliris | $3,762 million | -5% | | Ultomiris | $1,965 million | 42% | | Strensiq | $961 million | 11% | - Ultomiris is now the established standard of care in the US, Germany, and Japan for both PNH and aHUS, two life-threatening rare diseases[156](index=156&type=chunk) - The company is advancing a broad development portfolio to inhibit complement system targets beyond C5, including Factor D and Factor P, to pursue a range of new indications[156](index=156&type=chunk) [Business Review](index=34&type=section&id=Business%20Review) This review details AstraZeneca's operational execution across Science and Innovation, Growth and Therapy Area Leadership, and People and Sustainability, highlighting $9.8 billion R&D investment, 19% Total Revenue growth to $44.4 billion, and reaching 44.6 million people through healthcare access programs [Science and Innovation](index=35&type=section&id=Science%20and%20Innovation_br) AstraZeneca invested $9.8 billion in R&D in 2022, maintaining a pipeline of 179 projects with 19% productivity, focusing on enhancing disease biology, creating next-generation therapeutics, and upholding bioethical principles including clinical trial transparency - R&D expenditure was **$9,762 million** in 2022, with 60% allocated to late-stage development and 40% to discovery and early-stage development[168](index=168&type=chunk) - The R&D pipeline includes **179 projects**, with 155 in the clinical phase, and in 2022, there were **29 pipeline progression events** and **72 regulatory events** (submissions or approvals)[163](index=163&type=chunk)[175](index=175&type=chunk) [Growth and Therapy Area Leadership](index=39&type=section&id=Growth%20and%20Therapy%20Area%20Leadership_br) This section details commercial performance, with Total Revenue increasing 19% to $44.4 billion, strong growth in the US (+47%), 198 successful market launches, and 23 major business development transactions including acquisitions of TeneoTwo and Neogene Therapeutics 2022 Total Revenue by Geography | Region | 2022 Revenue ($) | Actual Growth % | | :--- | :--- | :--- | | US | $17,920 million | 47% | | Emerging Markets | $11,745 million | -4% | | Europe | $8,738 million | 9% | | Established Rest of World | $5,948 million | 22% | - The company delivered **198 successful market launches** in 2022 and continued to implement its Operations 2025 program to scale capabilities[184](index=184&type=chunk)[206](index=206&type=chunk) - Key business development deals in 2022 include the acquisitions of CinCor Pharma, Neogene Therapeutics, and TeneoTwo to strengthen the pipeline in hypertension, cell therapies, and haematology, respectively[213](index=213&type=chunk) [People and Sustainability](index=44&type=section&id=People%20and%20Sustainability_br) AstraZeneca focuses on its people and societal impact, with 49.5% of senior roles held by women, reaching 44.6 million people through access programs, achieving a 59.3% reduction in Scope 1 & 2 GHG emissions, and committing to high ethical standards - **49.5% of senior middle management roles** and above are filled by women, and voluntary employee turnover decreased to **11%** in 2022 from 14% in 2021[216](index=216&type=chunk)[223](index=223&type=chunk) - The company's flagship Access to Healthcare programmes (Healthy Heart Africa, Young Health Programme, etc.) have reached a cumulative **44.6 million people**[217](index=217&type=chunk)[220](index=220&type=chunk) - Progress on the 'Ambition Zero Carbon' strategy includes a **59.3% reduction** in Scope 1 and 2 GHG emissions from the 2015 baseline and a commitment to plant **50 million trees** by 2025[219](index=219&type=chunk)[236](index=236&type=chunk) [EU Taxonomy Disclosure](index=52&type=section&id=EU%20Taxonomy%20Disclosure) AstraZeneca's core pharmaceutical business is not covered by the EU Taxonomy, resulting in 0% Taxonomy-aligned revenue, though 14% of Capex and 2% of Opex in 2022 were Taxonomy-eligible for activities like building construction and vehicle fleets - The Group's revenues are wholly derived from the business of pharmaceuticals, which is not currently covered by the EU Taxonomy, resulting in a Taxonomy-eligible Revenue KPI of **0%**[241](index=241&type=chunk) Taxonomy-Eligible Expenditure KPIs 2022 | Expenditure Type | Taxonomy-Eligible KPI | | :--- | :--- | | Capital Expenditure (Capex) | 14% | | Operating Expenditure (Opex) | 2% | [Task Force on Climate-related Financial Disclosures (TCFD) Summary Statement](index=53&type=section&id=Task%20Force%20on%20Climate-related%20Financial%20Disclosures%20Summary%20Statement) AstraZeneca aligns its disclosures with the TCFD framework, covering governance, strategy, risk management, and metrics, with the Board's Sustainability Committee overseeing climate strategy and aiming for a 98% reduction in Scope 1 & 2 emissions by 2026 and net-zero by 2045 - The company's disclosures are consistent with the four TCFD recommendations: Governance, Strategy, Risk Management, and Metrics and Targets[248](index=248&type=chunk) - Physical climate risk assessments were conducted on **29 key sites** and over **750 critical suppliers** to ensure supply chain resilience[250](index=250&type=chunk) - Transition risks are highest for asthma and COPD products due to propellants, with the company investing in next-generation inhalers with near-zero Global Warming Potential (GWP) as part of its Ambition Zero Carbon strategy[251](index=251&type=chunk) [Risk Overview](index=56&type=section&id=Risk%20Overview) AstraZeneca identifies and manages Principal Risks across product pipeline, commercialization, supply chain, legal, and economic categories, and the Board has issued a viability statement confirming the company's ability to operate and meet liabilities over a three-year period - Principal Risks are grouped into five categories: Product pipeline, Commercialisation, Supply chain & business execution, Legal, regulatory & compliance, and Economic & financial[269](index=269&type=chunk)[271](index=271&type=chunk)[276](index=276&type=chunk)[282](index=282&type=chunk) - Key risks include failure to deliver the pipeline, pricing and access pressures, supply chain disruptions, failure of IT or cybersecurity, and geopolitical volatility[269](index=269&type=chunk)[270](index=270&type=chunk)[271](index=271&type=chunk)[275](index=275&type=chunk)[282](index=282&type=chunk) - The Board has issued a viability statement, confirming its reasonable expectation that the company can continue operations and meet its liabilities over a three-year period to December 31, 2025, even under severe but plausible downside scenarios[267](index=267&type=chunk) [Financial Review](index=60&type=section&id=Financial%20Review) The Financial Review details AstraZeneca's strong 2022 performance with Total Revenue of $44.4 billion (+19%) and Core EPS of $6.66 (+26%), explaining the use of non-GAAP 'Core' measures, covering profitability, cash flow, debt management, and providing 2023 guidance for low-to-mid single-digit revenue growth Reconciliation of Reported to Core Results (2022, $m) | Metric | Reported ($) | Adjustments ($) | Core ($) | | :--- | :--- | :--- | :--- | | Gross Profit | 31,960 million | 3,803 million | 35,763 million | | Operating Profit | 3,757 million | 9,593 million | 13,350 million | | Profit Before Tax | 2,501 million | 9,870 million | 12,371 million | | Basic EPS ($) | 2.12 | 4.54 | 6.66 | - Collaboration Revenue increased **54%** to **$1,353 million**, including **$519 million** from the Enhertu alliance with Daiichi Sankyo and **$355 million** in milestones from the MSD collaboration on Lynparza/Koselugo[301](index=301&type=chunk)[306](index=306&type=chunk)[310](index=310&type=chunk) - Net debt decreased from **$24.3 billion** at year-end 2021 to **$22.9 billion** at year-end 2022, supported by strong operating cash flow of **$9.8 billion**[317](index=317&type=chunk)[322](index=322&type=chunk)[324](index=324&type=chunk) - For 2023, the company guides for low-to-mid single-digit Total Revenue growth and high single-digit to low double-digit Core EPS growth[337](index=337&type=chunk) Corporate Governance [Corporate Governance Overview](index=79&type=section&id=Corporate%20Governance%20Overview) AstraZeneca's governance structure is led by the Board of Directors, responsible for strategy and oversight, delegating to the CEO and five Board Committees, while complying with the UK Corporate Governance Code and actively engaging with a wide range of stakeholders - The governance structure consists of the Board and five committees: Audit, Nomination and Governance, Remuneration, Science, and Sustainability[350](index=350&type=chunk) - The Board considers all Non-Executive Directors to be independent, with the exception of Marcus Wallenberg due to his length of tenure and relationship with a significant shareholder (Investor AB)[378](index=378&type=chunk) - Key Board decisions in 2022, such as the appointment of a new Chair, endorsement of the climate strategy, and approval of acquisitions, were made with consideration for key stakeholders and long-term success factors[397](index=397&type=chunk) [Audit Committee Report](index=96&type=section&id=Audit%20Committee%20Report) The Audit Committee, chaired by Philip Broadley, oversees financial reporting integrity, internal controls, and audit processes, focusing on Alexion integration, significant transactions, and reviewing key financial reporting issues like intangible asset valuation and litigation provisions, while recommending PwC's reappointment - The committee monitored significant financial reporting issues, including the valuation of **$38.9 billion** in intangible assets, US revenue recognition accruals, legal provisions of **$161 million**, and uncertain tax liabilities of **$830 million**[436](index=436&type=chunk)[437](index=437&type=chunk)[441](index=441&type=chunk) - The committee oversaw compliance with the Sarbanes-Oxley Act (SOx), noting that Alexion was fully integrated into the internal controls reporting framework in 2022[429](index=429&type=chunk) - The committee reviewed the effectiveness of the external auditor, PwC, and recommended their reappointment for the 2023 financial year, with fees for audit-related and other assurance services at **4%** of the statutory audit fee in 2022[448](index=448&type=chunk)[453](index=453&type=chunk) [Directors' Remuneration Report](index=104&type=section&id=Directors%27%20Remuneration%20Report) The Remuneration Committee outlines its pay-for-performance philosophy, with Executive Directors' 2022 annual bonus at 92% of maximum and the 2020 PSP vesting at 97% of maximum due to strong performance and a 58% three-year TSR, while the CEO's total realised pay was £15.3 million 2022 Executive Director Realised Pay (Single Total Figure) | Executive Director | 2022 Realised Pay (£) | 2021 Realised Pay (£) | | :--- | :--- | :--- | | Pascal Soriot (CEO) | £15,323 thousand | £15,740 thousand | | Aradhana Sarin (CFO) | £2,735 thousand | £3,013 thousand | - The 2022 annual bonus paid out at **92% of maximum opportunity**, based on a formulaic scorecard outcome of 183% of target[470](index=470&type=chunk)[511](index=511&type=chunk)[517](index=517&type=chunk) - The 2020-2022 Performance Share Plan (PSP) vested at **97% of maximum**, reflecting strong performance in science, revenue, cash flow, and a relative TSR ranking of 5th out of 16 peers[471](index=471&type=chunk)[525](index=525&type=chunk) - The CEO to median UK employee pay ratio for 2022 was **159:1**, a decrease from 162:1 in 2021[569](index=569&type=chunk) Financial Statements [Consolidated Statements](index=138&type=section&id=Consolidated%20Statements) The consolidated financial statements present the Group's financial performance and position, showing a 2022 profit of $3.3 billion on Total Revenue of $44.4 billion, total assets of $96.5 billion, and net cash inflow from operating activities of $9.8 billion Consolidated Income Statement Highlights (Year ended Dec 31, $m) | Line Item | 2022 ($) | 2021 ($) | | :--- | :--- | :--- | | Total Revenue | 44,351 million | 37,417 million | | Operating Profit | 3,757 million | 1,056 million | | Profit for the period | 3,293 million | 115 million | | Basic EPS ($) | 2.12 | 0.08 | Consolidated Statement of Financial Position Highlights (As of Dec 31, $m) | Line Item | 2022 ($) | 2021 ($) | | :--- | :--- | :--- | | Total Assets | 96,483 million | 105,363 million | | Total Liabilities | 59,425 million | 66,076 million | | Total Equity | 37,058 million | 39,287 million | [Group Accounting Policies](index=142&type=section&id=Group%20Accounting%20Policies) This section outlines the accounting policies for the consolidated financial statements, prepared in accordance with UK-adopted IAS and IFRS, detailing the basis of preparation, key judgements, and significant estimates, particularly concerning revenue recognition, impairment of intangible assets, and business combinations - The financial statements are prepared in accordance with UK-adopted IAS, IFRS as issued by the IASB, and IFRS as adopted by the EU[618](index=618&type=chunk) - The preparation of financial statements requires management to make significant estimates and judgements, particularly in areas like revenue recognition (US rebates), impairment of intangible assets, and legal provisions[618](index=618&type=chunk)

Full Year and Q4 2022 Results Conference call and webcast for investors and analysts Forward-looking statements Astra ...