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AstraZeneca(AZN) - 2023 Q3 - Quarterly Report
2023-11-08 16:00
FORM 6-K SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of November 2023 Commission File Number: 001-11960 AstraZeneca PLC 1 Francis Crick Avenue Cambridge Biomedical Campus Cambridge CB2 0AA United Kingdom Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F X Form 40-F __ Indicate by check mark if the registra ...
AstraZeneca(AZN) - 2023 Q2 - Earnings Call Transcript
2023-07-28 17:34
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 ...
AstraZeneca(AZN) - 2023 Q2 - Earnings Call Presentation
2023-07-28 12:34
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 ...
阿斯利康(US ADR)(AZN) - 2023 Q2 - Quarterly Report
2023-07-27 16:00
[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)
ASCO
2023-06-06 11:20
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 (AZN) ASCO Investor Event
2023-06-06 11:17
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 (AZN) Presents at the 2023 American Association for Cancer Research (AACR) - Slideshow
2023-05-01 10:39
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(AZN) - 2023 Q1 - Earnings Call Transcript
2023-04-27 18:12
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 ...
AstraZeneca(AZN) - 2022 Q4 - Annual Report
2023-02-20 16:00
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 ...
AstraZeneca(AZN) - 2022 Q4 - Annual Report
2023-02-20 16:00
What science can do AstraZeneca Annual Report and Form 20-F Information 2022 Welcome Welcome See what science can do on page 00 Science can... Science can... We are a global, science-led, patient-focused pharmaceutical company. From the beginning, science has been at the front and centre of everything we do, taking us to places we never thought possible. We are a global, science-led, patient-focused pharmaceutical company. We are dedicated to transforming the future of healthcare by unlocking the power of w ...