Last checked at 9 Feb 2023 07:00
AstraZeneca
9 February 2023 07:00 GMT
Full year and Q4 2022 results
Strong performance and pipeline progress in 2022 underpins 2023 outlook
On track to deliver industry-leading revenue growth through 2025 and beyond
Revenue and EPS summary
FY 2022 | Q4 2022 | ||||||
% Change | % Change | ||||||
|
| $m | Actual | CER[1] | $m | Actual | CER |
- Product Sales | 42,998 | 18 | 24 | 10,798 | (6) | 2 | |
- Collaboration Revenue | 1,353 | 54 | 56 | 409 | (20) | (19) | |
Total Revenue | 44,351 | 19 | 25 | 11,207 | (7) | 1 | |
Reported[2] EPS[3] | $2.12 | n/m | n/m | $0.58 | n/m | n/m | |
Core[4] EPS | $6.66 | 26 | 33 | $1.38 | (17) | (5) | |
Financial performance (FY 2022 figures unless otherwise stated, growth numbers and commentary at CER)
‒ Total Revenue increased 25% to $44,351m, with growth coming from all therapy areas, and from the addition of Alexion, which was incorporated into the Group's results from 21 July 2021
‒ Total Revenue in the fourth quarter was impacted by the decline in Vaxzevria. Excluding Vaxzevria, Total Revenue in the quarter increased 17%
‒ Oncology Total Revenue including milestone receipts increased 20%; Oncology Product Sales increased 19%. Total Revenue CVRM[5] increased 19%[6], R&I[7] increased 3%, and Rare Disease increased 10%6
‒ Core Gross Margin of 80%, up six percentage points, reflecting the lower revenue from Vaxzevria and the increased share of Oncology and Rare Disease medicines. Core Gross Margin of 77% in the fourth quarter was impacted by inventory write downs and manufacturing termination fees for Evusheld
‒ Core Total Operating Expense increased 23%, reflecting the addition of Alexion, and continued investment in new launches and the pipeline to deliver sustainable long-term growth
‒ Core Operating Margin of 30%, up four percentage points
‒ Core EPS increased 33% to $6.66. Second interim dividend declared of $1.97 per share, making a total dividend declared for FY 2022 of $2.90 for the year. The Core Tax Rate for the year was 17%, reflecting IP incentive regimes, geographical mix of profits and adjustments to prior year tax liabilities
FY 2023 Guidance summary (Growth numbers at CER)
‒ Total Revenue is expected to increase by a low-to-mid single-digit percentage
‒ Total Revenue excluding COVID-19 medicines[8] is expected to increase by a low double-digit percentage
‒ Core EPS is expected to increase by a high single-digit to low double-digit percentage
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
"2022 was a year of continued strong company performance and execution of our long-term growth strategy. We made excellent pipeline progress with a record 34 approvals in major markets and we are initiating new late-stage trials for high potential medicines such as camizestrant, datopotamab deruxtecan and volrustomig.
In 2023, we expect to see another year of double-digit revenue growth at CER, excluding our COVID-19 medicines. We will continue to invest behind our pipeline and recent launches while continuing to improve profitability. We plan to initiate more than thirty Phase III trials this year, of which ten have the potential to deliver peak year sales over one billion dollars.
Our R&D success and revenue increase in 2022 demonstrate that we are on track to deliver industry-leading revenue growth through 2025 and beyond, and have set AstraZeneca on a path to deliver at least fifteen new medicines before the end of the decade."
Key milestones achieved since the prior results
‒ Key regulatory approvals: US approval for Airsupra (PT027) in asthma. EU approvals for Lynparza[9] in mCRPC[10] (PROpel), Enhertu in gastric cancer (DESTINY-Gastric01) and HER2[11]-low breast cancer (DESTINY-Breast04), Imfinzi in biliary tract cancer (TOPAZ-1), Imfinzi+Imjudo in HCC[12] and Forxiga in heart failure with preserved ejection fraction. Five approvals in Japan, including Imfinzi and Imjudo in liver cancer (TOPAZ-1) and NSCLC[13] (POSEIDON) and Calquence for treatment-naïve CLL (ELEVATE-TN)
‒ Other regulatory milestones: US Fast Track designations for capivasertib in HR-positive HER2-negative breast cancer (CAPItello-291), tozorakimab in treatment/prevention of acute respiratory failure in patients with viral lung infection (TILIA), and Orpathys plus Tagrisso in NSCLC with MET[14] overexpression (SAVANNAH/SAFFRON); US Orphan Drug Designation for Saphnelo in idiopathic inflammatory myopathies; US Emergency Use Authorisation for Evusheld revised - as of January 2023, Evusheld is not currently authorised for use in the US.
Guidance
The Company provides guidance for FY 2023 at CER, based on the average exchange rates through 2022.
Total Revenue is expected to increase by a low-to-mid single-digit percentage
Excluding COVID-19 medicines, Total Revenue is expected to increase by a low double-digit percentage
Core EPS is expected to increase by a high single-digit to low double-digit percentage
‒ While challenging to forecast, Total Revenue from COVID-19 medicines (Vaxzevria, Evusheld and AZD3152, the COVID-19 LAAB[15] currently in development) is expected to decline significantly in FY 2023, with minimal revenue from Vaxzevria
‒ Total Revenue from China is expected to return to growth and increase by a low single-digit percentage in FY 2023
‒ Collaboration Revenue and Other Operating Income are both expected to increase, driven by continued growth of our partnered medicines, success-based milestones, and certain anticipated transactions
‒ Core Operating Expenses are expected to increase by a low-to-mid single-digit percentage, driven by investment in recent launches and the ungating of new trials
‒ The Core Tax Rate is expected to be between 18-22%
The Company is unable to provide guidance on a Reported basis because it cannot reliably forecast material elements of the Reported result, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement.
Currency impact
If foreign exchange rates for February to December 2023 were to remain at the average rates seen in January 2023, it is anticipated that FY 2023 Total Revenue and FY 2023 Core EPS would both incur a low single-digit adverse impact versus the performance at CER.
The Company's foreign exchange rate sensitivity analysis is provided in Table 17.
Table 1: Key elements of Total Revenue performance in Q4 2022
| % Change |
|
|
Revenue type | $m | Actual | CER |
|
| |
Product Sales | 10,798 | (6) | 2 | * Decline of 6% (2% increase at CER) due to lower sales of Vaxzevria[16] * Strong growth in Oncology, CVRM and Rare Disease | ||
Collaboration Revenue | 409 | (20) | (19) | * $188m for Enhertu (Q4 2021: $60m) * $37m for Tezspire (Q4 2021: $nil) * Milestone of $105m for Lynparza | ||
Total Revenue | 11,207 | (7) | 1 | * Excluding Vaxzevria, Q4 2022 Total Revenue increased by 8% (17% at CER) - see below | ||
Therapy areas | $m | Actual | CER |
|
| |
Oncology | 4,046 | 4 | 12 | * Strong performance across key medicines and regions | ||
CVRM6 | 2,284 | 12 | 22 |
| * Farxiga up 39% (52% CER), Lokelma up 50% (63% at CER), roxadustat up 61% (83% CER), Brilinta decreased 1% (increased 4% at CER) | |
R&I | 1,485 | (7) | (1) | * Growth in Fasenra, Breztri and Saphnelo offset by decline in Pulmicort of 33% (28% at CER) primarily due to the impact of VBP[17] implementation in China | ||
V&I[18] | 1,163 | (50) | (43) | * $734m from Evusheld (Q4 2021: $135m) * $95m from Vaxzevria (Q4 2021: $1,762m) | ||
Rare Disease6 | 1,816 | 4 | 10 | * Ultomiris up 52% (62% at CER) as gMG launch and conversion progressed; offset by decline in Soliris * Strensiq up 24% (27% at CER) reflecting strength of patient demand and geographic expansion | ||
Other Medicines | 412 | (2) | 12 | |||
Total Revenue | 11,207 | (7) | 1 | |||
Regions inc. Vaxzevria | $m | Actual | CER |
|
| |
Emerging Markets | 2,733 | (25) | (18) | * Decline due to lower sales of Vaxzevria (growth rates excluding Vaxzevria shown below) | ||
- China | 1,194 | (9) | 3 | * Second consecutive quarter of growth at CER | ||
- Ex-China Emerging Markets | 1,538 | (35) | (29) | * Decline due to lower sales of Vaxzevria | ||
US | 4,788 | 22 | 22 | |||
Europe | 2,308 | (20) | (8) | * Decline due to lower sales of Vaxzevria | ||
Established RoW | 1,378 | (11) | 8 | |||
Total Revenue inc. Vaxzevria | 11,207 | (7) | 1 | |||
Regions exc. Vaxzevria |
| $m | Actual | CER |
|
|
Emerging Markets | 2,678 | 7 | 18 | |||
- China | 1,194 | (8) | 4 | * Second consecutive quarter of growth at CER | ||
- Ex-China Emerging Markets | 1,484 | 24 | 33 | * Strong growth in Oncology and CVRM * $246m from Evusheld in Q4 (Q4 2021: $69m) | ||
US | 4,788 | 24 | 24 | * Growth in Oncology medicines | ||
Europe | 2,268 | (12) | 1 | |||
Established RoW | 1,378 | 4 | 27 | |||
Total Revenue exc. Vaxzevria | 11,112 | 8 | 17 |
Table 2: Key elements of financial performance in Q4 2022
Metric | Reported | Reported change | Core | Corechange | Comments[19] | |
Total Revenue | $11,207m | -7% Actual 1% CER | $11,207m | -7% Actual 1% CER | * Excluding Vaxzevria, Q4 2022 Total Revenue increased by 8% (17% at CER) * See Table 1 and the Total Revenue section of this document for further details | |
Gross margin[20] | 73% | 13pp Actual 15pp CER | 77% | 3pp Actual 4pp CER | + Increasing mix of sales from Oncology and Rare Disease medicines + Decreasing mix of Vaxzevria sales ‒ Negative impact in the quarter from currency fluctuations ‒ Inventory write downs and manufacturing termination fees relating to Evusheld reduced Gross Profit by $335m in Q4 2022 ‒ Mix impact from profit-sharing arrangements(e.g. Lynparza) ‒ Reported Gross Margin impacted by unwind of Alexion inventory fair value adjustment | |
R&D expense | $2,625m | 2% Actual 9% CER | $2,526m | 5% Actual 12% CER | + Increased investment in the pipeline * Core R&D-to-Total Revenue ratio of 23% (Q4 2021: 20%) | |
SG&A expense | $4,621m | -10% Actual -3% CER | $3,583m | 6% Actual 15% CER | + Market development activities for recent launches + Core SG&A-to-Total Revenue ratio of 32%(Q4 2021: 28%). The year-on-year comparison is impacted by differences in cost phasing during H2 2021 and H2 2022 | |
Other operating income[21] | $189m | 29% Actual 33% CER | $130m | -11% Actual -7% CER | * Reported and Core OOI includes income from sale of the Waltham site | |
Operating margin | 10% | 12pp Actual 14pp CER | 23% | -4pp Actual -3pp CER | * See Gross Margin and Expensescommentary above | |
Net finance expense | $315m | -6% Actual stable at CER | $245m | 5% Actual 9% CER | * Reported impacted by a reduction in the discount unwind on acquisition-related liabilities | |
Tax rate | -16% | n/m | 10% | -7pp Actual -6pp CER | * The Reported and Core Tax Rates in the quarter reflected IP incentive regimes, geographical mix of profits and adjustments to prior year tax liabilities including several one-time items * Variations in the tax rate can be expected to continue quarter to quarter | |
EPS | $0.58 | n/m | $1.38 | -17% Actual -5% CER | * Further details of differences between Reported and Core are shown in Table 12 |
Table 3: Pipeline highlights since prior results announcement
Event | Medicine | Indication / Trial | Event |
Regulatory approvals and other regulatory actions | Imfinzi +/- Imjudo | NSCLC (1st-line) (POSEIDON) | Regulatory approval (US, JP) |
Imfinzi + Imjudo | Hepatocellular carcinoma (1st-line) (HIMALAYA) | Regulatory approval (JP) | |
Imfinzi | Biliary tract cancer (TOPAZ-1) | Regulatory approval (EU, JP) | |
Lynparza | mCRPC (1st-line) (PROpel) | Regulatory approval (EU) | |
Enhertu | HER2-positive breast cancer (2nd-line) (DESTINY-Breast03) | Regulatory approval (JP) | |
Enhertu | HER2-low breast cancer (3rd-line) (DESTINY-Breast04) | Regulatory approval (EU) | |
Enhertu | HER2-positive/HER2-low gastric(2nd-line) (DESTINY-Gastric01,DESTINY-Gastric02) | Regulatory approval (EU) | |
Calquence | CLL[22] (ELEVATE-TN) | Regulatory approval (JP) | |
Calquence | Maleate tablet formulation | Regulatory approval (EU) | |
Forxiga | HFpEF[23] (DELIVER) | Regulatory approval (EU, JP) | |
Airsupra | Severe asthma (MANDALA/DENALI) | Regulatory approval (US) | |
Tezspire | Pre-filled pen | Regulatory approval (US, EU) | |
Regulatory submissionsor acceptances
| Enhertu | HER2-mutated NSCLC (2nd-line+) (DESTINY-Lung01) | Regulatory submission (EU, JP) |
Calquence | CLL (ASCEND) | Regulatory submission (CN) | |
Beyfortus | RSV[24] (MELODY/MEDLEY) | Regulatory submission (US) | |
Soliris | NMOSD[25] | Regulatory submission (CN) | |
Major Phase III data readouts and other developments | Imfinzi | NSCLC (1st-line) (PEARL) | Primary endpoint not met |
capivasertib | HR[26]+/HER2-negative breast cancer (1st-line) (CAPItello-291) | Fast Track Designation (US) | |
Orpathys + Tagrisso | NSCLC with MET overexpression (SAVANNAH/SAFFRON) | Fast Track Designation (US) | |
tozorakimab | Treatment/prevention of acute respiratory failure in patients with viral lung infection (TILIA) | Fast Track Designation (US) | |
Saphnelo | Idiopathic inflammatory myopathies | Orphan Drug Designation (US) | |
Evusheld | Pre-exposure prophylaxis of COVID-19 | Revision of Emergency Use Authorisation (US) - Evusheld is not currently authorised in the US until further notice from the FDA[27] |
Corporate and business development
In January 2023, AstraZeneca entered into a definitive agreement to acquire CinCor Pharma, Inc. (CinCor), a US-based clinical-stage biopharmaceutical company focused on developing novel treatments for resistant and uncontrolled hypertension as well as chronic kidney disease. The acquisition will bolster AstraZeneca's cardiorenal pipeline by adding CinCor's candidate drug, baxdrostat (CIN-107), an aldosterone synthase inhibitor for blood pressure lowering in treatment-resistant hypertension.
AstraZeneca has initiated a tender offer to acquire all of CinCor's outstanding shares for a price of $26 per share in cash at closing, plus a non-tradable contingent value right of $10 per share in cash payable upon a specified regulatory submission of a baxdrostat product. Combined, the upfront and maximum potential contingent value payments represent, if achieved, a transaction value of approximately $1.8bn. As part of the transaction, AstraZeneca will acquire the cash and marketable securities on CinCor's balance sheet, which totalled approximately $522m as of 30 September 2022.
In January 2023, AstraZeneca completed the acquisition of Neogene Therapeutics Inc. (Neogene), a global clinical-stage biotechnology company pioneering the discovery, development and manufacturing of next-generation T-cell receptor therapies that offer a novel cell therapy approach for targeting cancer. AstraZeneca acquired outstanding equity of Neogene for a total consideration of up to $320m, on a cash and debt free basis. This includes an initial payment of $200m on deal closing, and a further up to $120m in both contingent milestones-based and non-contingent consideration.
Following the approval of Airsupra in January 2023, AstraZeneca has notified Avillion of its intention to commercialise Airsupra in the US. Under the terms of the agreement with Avillion, AstraZeneca will pay single-digit royalties and milestones based on future sales and developments.
In December 2022, AstraZeneca completed the sale of its R&D facility in Waltham, Massachusetts, US, to Alexandria Real Estate Equities, Inc, (ARE), a leading owner, operator and developer of life science campuses. ARE will lease the site back to AstraZeneca for a four-year term while construction is being completed on the new AstraZeneca R&D Centre and Alexion Headquarters in Kendall Square, Cambridge, Massachusetts, announced in April 2022.
In January 2023, AstraZeneca completed the sale of its West Chester site in Ohio, US, to National Resilience, Inc., a technology-focused manufacturing company dedicated to broadening access to complex medicines. The West Chester site will continue to manufacture medicines for AstraZeneca.
Post Alexion Acquisition Group Review (PAAGR)
In conjunction with the acquisition of Alexion in 2021, AstraZeneca initiated a comprehensive review, aimed at integrating systems, structure and processes, optimising the global footprint and prioritising resource allocations and investments. These activities are expected to be substantially complete by the end of 2025, with a number of planned activities having commenced in late 2021 and during 2022.
During 2022, the Company has refined the scope and estimates of the planned activities, resulting in an increase to the expected one-time restructuring costs over the life of the programme of $0.5bn, of which $0.3bn are non-cash costs, an increase in capital investments of $0.1bn, and an increase to the anticipated annual run-rate pre-tax benefits by the end of 2025 of $0.7bn.
In addition, initial financial estimates for the Company's planned upgrade of its Enterprise Resource Planning IT systems have been completed, resulting in anticipated incremental capital investments for software assets of $0.6bn and one-time restructuring cash costs of $0.3bn. This investment builds strongly on the PAAGR and is expected to be substantially complete by the end of 2030, realising significant strategic and compliance-related benefits from transforming core enterprise-wide processes, harmonising systems architecture and enabling future digital capabilities.
Consequently, the total programme activities are now anticipated to incur one-time restructuring costs of approximately $2.9bn, of which approximately $1.9bn are cash costs and $1.0bn are non-cash costs, and capital investments of approximately $0.9bn.
Run-rate pre-tax benefits, before reinvestment, are now expected to be approximately $1.9bn by the end of 2025. In line with established practice, restructuring costs will be excluded from our Core (non-GAAP) financial measures.
During 2022, AstraZeneca recorded restructuring charges of approximately $0.7bn in relation to the PAAGR (2021: $1.0bn), bringing the cumulative charges to date under this programme to $1.7bn. Of these costs, $0.7bn are non-cash costs arising primarily from impairments and accelerated depreciation on affected assets. As at 31 December 2022, the PAAGR has realised annual run-rate pre-tax benefits, before reinvestment, of $0.8bn.
Sustainability summary
In November 2022, AstraZeneca achieved third position overall in the 2022 Access to Medicine Index.
In January 2023, Chair Leif Johansson alongside Senior Executive Team members Marc Dunoyer, Dave Fredrickson and Iskra Reic attended the World Economic Forum in Davos, focusing on investing in health as the foundation of strong and resilient societies, and the need for collective early action to build more sustainable and equitable healthcare systems, including through collaborations such as the Partnership for Health System Sustainability and Resilience and the Sustainable Markets Initiative.
Management changes
Katarina Ageborg, EVP Global Sustainability and Chief Compliance Officer, has announced her retirement. Jeffrey Pott, Chief Human Resources Officer and General Counsel, will assume responsibility as Chief Compliance Officer in addition to his current responsibilities. Pam Cheng, Executive Vice-President, Operations and Information Technology, will assume responsibility for leadership of Sustainability strategy and function in addition to her existing responsibilities. The Board thanks Katarina for her lasting legacy, having positioned AstraZeneca amongst the global leaders in sustainability, backed by world-leading platforms and science-based targets.
Conference call
A conference call and webcast for investors and analysts will begin today, 9 February 2023, at 11:45 GMT. Details can be accessed via astrazeneca.com.®
Reporting calendar
The Company intends to publish its results for the first quarter of 2023 on Thursday 27 April 2023.
Operating and financial review
All narrative on growth and results in this section is based on actual exchange rates, and financial figures are in US$ millions ($m), unless stated otherwise. Unless stated otherwise, the performance shown in this announcement covers the twelve-month period to 31 December 2022 ('the year' or 'FY 2022') compared to the twelve-month period to 31 December 2021 (FY 2021), or the three-month period to 31 December 2022 ('the fourth quarter' or 'Q4 2022') compared to the three-month period to 31 December 2021 ('Q4 2021').
Core financial measures, EBITDA, Net Debt, Gross Margin, Operating Margin and CER are non-GAAP financial measures because they cannot be derived directly from the Group's Condensed Consolidated Financial Statements. Management believes that these non-GAAP financial measures, when provided in combination with Reported results, provide investors and analysts with helpful supplementary information to understand better the financial performance and position of the Group on a comparable basis from period to period. These non-GAAP financial measures are not a substitute for, or superior to, financial measures prepared in accordance with GAAP.
Core financial measures are adjusted to exclude certain significant items, such as:
‒ Amortisation and impairment of intangible assets, including impairment reversals but excluding any charges relating to IT assets
‒ Charges and provisions related to restructuring programmes, which includes charges that relate to the impact of restructuring programmes on capitalised IT assets
‒ Alexion acquisition-related items, primarily fair value adjustments on acquired inventories and fair value impact of replacement employee share awards
‒ Other specified items, principally the imputed finance charge relating to contingent consideration on business combinations, legal settlements and the one-off deferred tax credit arising from the internal reorganisation to integrate Alexion
‒ The tax effects of the adjustments above are excluded from the Core Tax charge
Details on the nature of Core financial measures are provided on page 54 of the Annual Report and Form 20-F Information 2021.
Reference should be made to the Reconciliation of Reported to Core financial measures table included in the financial performance section in this announcement.
Gross Margin, previously termed Gross Profit Margin, is the percentage by which Product Sales exceeds the Cost of sales, calculated by dividing the difference between the two by the sales figure. The calculation of Reported and Core Gross Margin excludes the impact of Collaboration Revenue and any associated costs, thereby reflecting the underlying performance of Product Sales.
EBITDA is defined as Reported Profit before tax after adding back Net finance expense, results from Joint Ventures and Associates and charges for Depreciation, Amortisation and Impairment. Reference should be made to the Reconciliation of Reported Profit before tax to EBITDA included in the financial performance section in this announcement.
Net Debt is defined as Interest-bearing loans and borrowings and Lease liabilities, net of Cash and cash equivalents, Other investments, and net derivative financial instruments. Reference should be made to Note 3 'Net Debt' included in the Notes to the Condensed Consolidated Financial Statements in this announcement.
The Company strongly encourages investors and analysts not to rely on any single financial measure, but to review AstraZeneca's financial statements, including the Notes thereto, and other available Company reports, carefully and in their entirety.
Due to rounding, the sum of a number of dollar values and percentages in this announcement may not agree to totals.
Total Revenue
Table 4: Therapy area and medicine performance
|
| FY 2022 | Q4 2022 | ||||||
|
|
|
| % Change |
|
| % Change | ||
Product Sales |
| $m | % Total | Actual | CER | $m | % Total | Actual | CER |
Oncology |
| 14,631 | 33 | 13 | 19 | 3,746 | 33 | 9 | 18 |
- Tagrisso | 5,444 | 12 | 9 | 15 | 1,342 | 12 | 2 | 12 | |
- Imfinzi [28] | 2,784 | 6 | 15 | 21 | 752 | 7 | 19 | 27 | |
- Lynparza | 2,638 | 6 | 12 | 18 | 689 | 6 | 10 | 17 | |
- Calquence | 2,057 | 5 | 66 | 69 | 588 | 5 | 49 | 53 | |
- Enhertu | 79 | - | >4x | >4x | 28 | - | >3x | >3x | |
- Orpathys | 33 | - | >2x | >2x | (1) | - | n/m | n/m | |
- Zoladex | 927 | 2 | (2) | 6 | 210 | 2 | (9) | 4 | |
- Faslodex | 334 | 1 | (22) | (14) | 74 | 1 | (27) | (14) | |
- Iressa | 114 | - | (38) | (34) | 24 | - | (32) | (24) | |
- Arimidex | 99 | - | (29) | (24) | 14 | - | (57) | (50) | |
- Casodex | 78 | - | (45) | (40) | 16 | - | (28) | (16) | |
- Others | 44 | - | (14) | (6) | 10 | - | (29) | (18) | |
BioPharmaceuticals: CVRM 6 |
| 9,188 | 21 | 13 | 19 | 2,281 | 20 | 12 | 22 |
- Farxiga | 4,381 | 10 | 46 | 56 | 1,177 | 11 | 39 | 52 | |
- Brilinta | 1,358 | 3 | (8) | (4) | 345 | 3 | (1) | 4 | |
- Lokelma | 289 | 1 | 65 | 75 | 81 | 1 | 50 | 63 | |
- Roxadustat | 197 | - | 13 | 18 | 49 | - | 65 | 87 | |
- Andexxa 6 | 150 | - | 5 | 14 | 39 | - | - | 14 | |
- Crestor | 1,048 | 2 | (4) | 2 | 224 | 2 | (13) | (2) | |
- Seloken/Toprol-XL | 862 | 2 | (9) | (4) | 157 | 1 | (23) | (12) | |
- Bydureon | 280 | 1 | (27) | (26) | 73 | 1 | (20) | (20) | |
- Onglyza | 257 | 1 | (28) | (25) | 52 | - | (31) | (24) | |
- Others | 366 | 1 | (10) | (7) | 84 | 1 | (13) | (6) | |
BioPharmaceuticals: R&I |
| 5,765 | 13 | (4) | - | 1,447 | 13 | (9) | (3) |
- Symbicort | 2,538 | 6 | (7) | (2) | 620 | 6 | (9) | (2) | |
- Fasenra | 1,396 | 3 | 11 | 15 | 381 | 3 | 7 | 12 | |
- Breztri | 398 | 1 | 96 | >2x | 116 | 1 | 59 | 68 | |
- Saphnelo | 116 | - | >10x | >10x | 48 | - | >6x | >6x | |
- Tezspire | 4 | - | n/m | n/m | 4 | - | n/m | n/m | |
- Pulmicort | 645 | 1 | (33) | (31) | 166 | 1 | (33) | (28) | |
- Daliresp/Daxas | 189 | - | (17) | (16) | 28 | - | (52) | (52) | |
- Bevespi | 58 | - | 7 | 9 | 14 | - | (5) | (1) | |
- Others | 421 | 1 | (29) | (27) | 70 | 1 | (53) | (47) | |
BioPharmaceuticals: V&I |
| 4,736 | 11 | 2 | 8 | 1,129 | 10 | (51) | (44) |
- Vaxzevria |
| 1,798 | 4 | (54) | (52) | 85 | 1 | (95) | (94) |
- Evusheld |
| 2,185 | 5 | >10x | >10x | 734 | 7 | >8x | >9x |
- Synagis | 578 | 1 | 41 | 59 | 194 | 2 | (19) | (3) | |
- FluMist | 175 | - | (31) | (20) | 116 | 1 | (35) | (24) | |
Rare Disease 6 |
| 7,053 | 16 | 4 | 10 | 1,816 | 16 | 4 | 10 |
- Soliris 6 | 3,762 | 8 | (11) | (5) | 844 | 8 | (22) | (16) | |
- Ultomiris 6 | 1,965 | 4 | 34 | 42 | 593 | 5 | 52 | 62 | |
- Strensiq 6 | 958 | 2 | 16 | 18 | 272 | 2 | 24 | 27 | |
- Koselugo | 208 | - | 93 | 96 | 58 | 1 | 74 | 77 | |
- Kanuma 6 | 160 | - | 16 | 19 | 49 | - | 45 | 44 | |
Other Medicines |
| 1,625 | 4 | (5) | 4 | 379 | 3 | (7) | 7 |
- Nexium |
| 1,285 | 3 | (3) | 8 | 300 | 3 | (9) | 7 |
- Others | 340 | 1 | (10) | (7) | 79 | 1 | (1) | 5 | |
Product Sales |
| 42,998 | 97 | 18 | 24 | 10,798 | 96 | (6) | 2 |
Collaboration Revenue |
| 1,353 | 3 | 54 | 56 | 409 | 4 | (20) | (19) |
Total Revenue |
| 44,351 | 100 | 19 | 25 | 11,207 | 100 | (7) | 1 |
Table 5: Collaboration Revenue
FY 2022 | Q4 2022 | ||||||||
% Change |
|
| % Change | ||||||
| $m | % Total | Actual | CER | $m | % Total | Actual | CER | |
Enhertu: alliance revenue [29] | 519 | 38 | >2x | >2x | 187 | 46 | >3x | >3x | |
Tezspire: alliance revenue | 79 | 6 | n/m | n/m | 37 | 9 | n/m | n/m | |
Lynparza: regulatory milestones | 355 | 26 | n/m | n/m | 105 | 26 | n/m | n/m | |
Tralokinumab: sales milestones | 110 | 8 | n/m | n/m | - | - | - | - | |
Vaxzevria: royalties | 76 | 6 | 19 | 16 | 10 | 2 | n/m | n/m | |
Other royalty income | 72 | 5 | (42) | (41) | 17 | 4 | (75) | (74) | |
Other Collaboration Revenue | 142 | 10 | 49 | 69 | 53 | 13 | >10x | >10x | |
Total |
| 1,353 | 100 | 54 | 56 | 409 | 100 | (20) | (19) |
Table 6: Total Revenue by therapy area
FY 2022 | Q4 2022 | ||||||||
% Change | % Change | ||||||||
$m | % Total | Actual | CER | $m | % Total | Actual | CER | ||
Oncology | 15,539 | 35 | 15 | 20 | 4,046 | 36 | 4 | 12 | |
BioPharmaceuticals 6 | 20,010 | 45 | 5 | 11 | 4,932 | 44 | (17) | (9) | |
- CVRM6 |
| 9,211 | 21 | 13 | 19 | 2,284 | 20 | 12 | 22 |
- R&I |
| 5,963 | 13 | (1) | 3 | 1,485 | 13 | (7) | (1) |
- V&I |
| 4,836 | 11 | 1 | 8 | 1,163 | 10 | (50) | (43) |
Rare Disease6 | 7,053 | 16 | 4 | 10 | 1,816 | 16 | 4 | 10 | |
Other Medicines | 1,748 | 4 | (4) | 5 | 412 | 4 | (2) | 12 | |
Total |
| 44,351 | 100 | 19 | 25 | 11,207 | 100 | (7) | 1 |
Table 7: Total Revenue by region
FY 2022 | Q4 2022 | ||||||||
% Change | % Change | ||||||||
$m | % Total | Actual | CER | $m | % Total | Actual | CER | ||
Emerging Markets | 11,745 | 26 | (4) | 1 | 2,733 | 24 | (25) | (18) | |
- China |
| 5,792 | 13 | (4) | - | 1,194 | 11 | (9) | 3 |
- Ex-China |
| 5,953 | 13 | (5) | 1 | 1,538 | 14 | (35) | (29) |
US | 17,920 | 40 | 47 | 47 | 4,788 | 43 | 22 | 22 | |
Europe | 8,738 | 20 | 9 | 21 | 2,308 | 21 | (20) | (8) | |
Established RoW | 5,948 | 13 | 22 | 40 | 1,378 | 12 | (11) | 8 | |
Total |
| 44,351 | 100 | 19 | 25 | 11,207 | 100 | (7) | 1 |
Table 8: Total Revenue by region - excluding Vaxzevria
FY 2022 | Q4 2022 | ||||||||
% Change | % Change | ||||||||
$m | % Total | Actual | CER | $m | % Total | Actual | CER | ||
Emerging Markets | 10,940 | 25 | 10 | 16 | 2,678 | 24 | 7 | 18 | |
- China |
| 5,746 | 13 | (4) | (1) | 1,194 | 11 | (8) | 4 |
- Ex-China |
| 5,195 | 12 | 31 | 41 | 1,484 | 13 | 24 | 33 |
US | 17,840 | 40 | 47 | 47 | 4,788 | 43 | 24 | 24 | |
Europe | 8,372 | 19 | 19 | 33 | 2,268 | 20 | (12) | 1 | |
Established RoW | 5,323 | 12 | 24 | 43 | 1,378 | 12 | 4 | 27 | |
Total |
| 42,476 | 96 | 27 | 34 | 11,112 | 99 | 8 | 17 |
Oncology
Oncology Total Revenue increased by 15% (20% at CER) in FY 2022 to $15,539m and represented 35% of overall Total Revenue (FY 2021: 36%). This included Lynparza Collaboration Revenue of $355m (FY 2021: $400m) and Enhertu Collaboration Revenue of $523m (FY 2021: $197m). Product Sales increased by 13% (19% at CER) in FY 2022 to $14,631m, reflecting new launches and increased patient access for Tagrisso, Imfinzi, Lynparza and Calquence partially offset by declines in some older medicines.
Tagrisso
Total Revenue | Worldwide | Emerging Markets | US | Europe | Established RoW | ||
FY 2022 $m | 5,444 | 1,567 | 2,007 | 1,023 | 847 | ||
Actual change | 9% | 17% | 13% | 4% | (7%) | ||
CER change | 15% | 22% | 13% | 17% | 8% |
Region | Drivers and commentary | |
Worldwide | * Increased use of Tagrisso in adjuvant and 1st-line setting and expansion of reimbursed access, partially offset by COVID-19 headwinds | |
Emerging Markets | * Rising demand from increased patient access in China continues to offset the impact of the March 2021 NRDL[30] price reduction * The fourth quarter saw some impact from year-end ordering dynamics in China | |
US | * Improving use in 1st-line with longer duration of treatment and increasing adjuvant penetration, partially offset by lower 2nd-line use | |
Europe | * Greater use in 1st-line and adjuvant settings; established 1st-line standard of care in EU5[31], partially offset by lower 2nd-line use | |
Established RoW | * Increased use in 1st-line setting and launch progress in adjuvant, including Japan |
Imfinzi
Total Revenue | Worldwide | Emerging Markets | US | Europe | Established RoW | ||
FY 2022 $m | 2,784 | 287 | 1,552 | 544 | 401 | ||
Actual change | 15% | 4% | 25% | 12% | (1%) | ||
CER change | 21% | 7% | 25% | 26% | 15% |
Region | Drivers and commentary | |
Worldwide | * The Imfinzi revenue line includes sales of Imjudo, which commenced in Q4 2022 following approvals in the US for patients with unresectable liver cancer (HIMALAYA) and Stage IV NSCLC (POSEIDON) * Increased use of Imfinzi in GI, liver and lung cancer * Continued recovery in diagnosis and treatment rates following the COVID-19 pandemic across all regions, excluding China | |
Emerging Markets | * Growth in ex-China driven by improved diagnosis and treatment rates following the COVID‑19 pandemic | |
US | * New patient starts across Stage III NSCLC and ES-SCLC[32] * Strong launch in BTC[33] following September 2022 FDA approval (TOPAZ-1), and growing penetration of Imfinzi + Imjudo in metastatic NSCLC and HCC | |
Europe | * Increased market penetration in ES-SCLC, growth in the number of reimbursed markets, and ongoing recovery in rates of diagnosis and treatment | |
Established RoW | * New reimbursements |
Lynparza
Total Revenue | Worldwide | Emerging Markets | US | Europe | Established RoW | ||
FY 2022 $m | 2,993 | 488 | 1,226 | 1,010 | 269 | ||
Actual change | 9% | 27% | 13% | (1%) | 4% | ||
CER change | 14% | 31% | 13% | 7% | 20% |
Product Sales | Worldwide | Emerging Markets | US | Europe | Established RoW | ||
FY 2022 $m | 2,638 | 488 | 1,226 | 655 | 269 | ||
Actual change | 12% | 27% | 13% | 6% | 4% | ||
CER change | 18% | 31% | 13% | 19% | 20% |
Region | Drivers and commentary | |
Worldwide | * Lynparza remains the leading medicine in the PARP[34] inhibitor class globally across four tumour types, as measured by total prescription volume * Total Revenue includes $355m in regulatory milestones received from MSD and recognised in Europe, following approval in the US and EU for the adjuvant treatment of patients with gBRCAm[35] breast cancer (OlympiA), and approval in the EU for the treatment of mCRPC (PROpel) | |
Emerging Markets | * Increased patient access following admission to China's NRDL as a 1st-line maintenance treatment for BRCAm[36] ovarian cancer patients, with effect from March 2021; launches in other markets | |
US | * US launch in early breast cancer following March 2022 FDA approval (OlympiA) * Increased use in breast, ovarian and prostate cancers | |
Europe | * Increasing HRD testing rates and use in 1st-line HRD-positive ovarian cancer, increased Lynparza uptake in BRCAm mCRPC[37] and gBRCAm HER2-negative advanced breast cancer and the EU launch in gBRCAm early breast cancer following EMA[38] approval in August (OlympiA) | |
Established RoW | * New launches and high levels of HRD testing in Japan |
Enhertu
Total Revenue | Worldwide | Emerging Markets | US | Europe | Established RoW | ||
FY 2022 $m | 602 | 80 | 405 | 110 | 7 | ||
Actual change | >2x | >6x | >2x | >3x | >10x | ||
CER change | >2x | >6x | >2x | >3x | >10x |
Region | Drivers and commentary | |
Worldwide | * Excluding Japan, Enhertu global in-market sales recorded by Daiichi Sankyo Company Limited (Daiichi Sankyo) and AstraZeneca, amounted to $1,173m in the year (FY 2021: $426m) * AstraZeneca's Total Revenue of $602m includes $523m of Collaboration Revenue from its share of gross profit in territories where Daiichi Sankyo records product sales and royalties on sales in Japan | |
Emerging Markets | * Strong uptake in early launch markets | |
US | * US in-market sales, recorded by Daiichi Sankyo, amounted to $850m in the year (FY 2021: $357m) * Now standard of care in 2nd-line HER2-positive metastatic breast cancer following May 2022 FDA approval (DESTINY-Breast03) and after first chemotherapy in HER2-low metastatic breast cancer following August 2022 FDA approval (DESTINY-Breast04) | |
Europe | * Growth in 3rd-line+ HER2-positive metastatic breast and launch in 2nd-line HER2-positive metastatic breast cancer after EMA approval in July 2022 (DESTINY-Breast03) | |
Established RoW | * In Japan, AstraZeneca receives a mid-single-digit percentage royalty on sales made by Daiichi Sankyo |
Calquence
Total Revenue | Worldwide | Emerging Markets | US | Europe | Established RoW | ||
FY 2022 $m | 2,057 | 45 | 1,657 | 286 | 69 | ||
Actual change | 66% | >2x | 52% | >2x | >3x | ||
CER change | 69% | >2x | 52% | >2x | >4x |
Region | Drivers and commentary | |
Worldwide | * Increased penetration globally; leading BTKi[39] in key markets | |
US | * Increased share of new patient starts * Inventory build in Q3 following maleate tablet formulation launch in August; Q4 observed partial inventory work down | |
Europe | * Increased share of new patient starts |
Orpathys
Total Revenue of $33m (FY 2021: $16m), growth was driven by the 2021 launch in China, where it is approved for patients with lung cancer and MET gene alterations. Orpathys has been included in the updated NRDL in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations. The updated NRDL will take effect from 1 March 2023.
Other Oncology medicines
FY 2022 | % Change |
Total Revenue | $m | Actual | CER | ||
Zoladex | 957 | (1%) | 7% | * Increased use in ex-China Emerging Markets, offsetting a price cut in Japan | |
Faslodex | 334 | (22%) | (14%) | * Generic competition | |
Iressa | 114 | (38%) | (34%) | * Continued share loss to next-generation TKIs[40] | |
Arimidex | 99 | (29%) | (24%) | ||
Casodex | 78 | (45%) | (40%) | * Ongoing impact from VBP implementation | |
Other Oncology | 44 | (14%) | (6%) |
BioPharmaceuticals
Including V&I medicines, BioPharmaceuticals Total Revenue increased by 5% (11% at CER) in FY 2022 to $20,010m, representing 45% of overall Total Revenue (FY 2021: 51%). Growth was driven by strong Farxiga performance, Evusheld revenues offsetting the decline in Vaxzevria, and growth from newer R&I medicines offsetting decreases in Pulmicort and other older R&I medicines.
BioPharmaceuticals - CVRM
CVRM Total Revenue increased by 13% (19% at CER) to $9,211m in FY 2022, driven by a strong Farxiga performance, and represented 21% of overall Total Revenue (FY 2021: 22%).
Farxiga
Total Revenue | Worldwide | Emerging Markets | US | Europe | Established RoW | ||
FY 2022 $m | 4,386 | 1,665 | 1,071 | 1,297 | 353 | ||
Actual change | 46% | 39% | 46% | 60% | 31% | ||
CER change | 56% | 47% | 46% | 81% | 48% |
Region | Drivers and commentary | |
Worldwide | * Farxiga volume is growing faster than the overall SGLT2[41] market in all major regions * Additional benefit from continued growth in the overall SGLT2 inhibitor class * Further HF[42] and CKD launches and supportive updates to treatment guidelines including from ESC[43] and AHA[44]/ACC[45]/HFSA[46]. HF and CKD indications now launched in >100 markets | |
Emerging Markets | * Growth despite generic competition in some markets. Solid growth in ex-China Emerging Markets, particularly Latin America | |
US | * Regulatory approval for HFrEF[47] in May 2020, treatment of CKD in May 2021. Both approvals included patients with and without T2D[48] * Farxiga continued to gain in-class brand share, driven by HF and CKD launches | |
Europe | * The beneficial addition of cardiovascular outcomes trial data to the label, the HFrEF regulatory approval in November 2020, and CKD regulatory approval in August 2021 * Forxiga continued gaining in-class market share in the period | |
Established RoW | * In Japan, AstraZeneca sells to collaborator Ono Pharmaceutical Co., Ltd, which records in-market sales. Continued volume growth driven by HF and CKD launches |
Brilinta
Total Revenue | Worldwide | Emerging Markets | US | Europe | Established RoW | ||
FY 2022 $m | 1,358 | 286 | 744 | 282 | 46 | ||
Actual change | (8%) | (13%) | 1% | (18%) | (27%) | ||
CER change | (4%) | (10%) | 1% | (8%) | (22%) |
Region | Drivers and commentary | |
Emerging Markets | * Adverse impact from Brilinta's inclusion in China's VBP programme * Growth in ex-China Emerging Markets | |
US, Europe | * Q4 US sales growth favourably impacted by a one-time adjustment. Some market recovery of oral antiplatelet therapies following the pandemic |
Lokelma
Total Revenue increased 65% (75% at CER) to $289m in FY 2022, driven by Lokelma extending its branded market share lead in the US and also achieving total potassium binder market share leadership in the period. Continued progress in Europe from recent launches across the region where Lokelma extended its market share in the period. In China, Lokelma was admitted to the NRDL with effect from 1 January 2022 and is now the leading potassium binder in the country.
Roxadustat
Total Revenue increased 12% (17% at CER) to $202m, with roxadustat benefitting from increased volumes in China following NRDL price cuts.
Andexxa
On a pro forma basis, Andexxa Total Revenue increased 12% (21% at CER) to $160m.
Other CVRM medicines
FY 2022 | % Change |
Total Revenue | $m | Actual | CER | ||
Crestor | 1,050 | (4%) | 2% | * Sales growth at CER driven by Emerging Markets, offset by declines in the US and Europe | |
Seloken | 863 | (9%) | (4%) | * Emerging Markets sales impacted by China VBP implementation of Betaloc[49] oral in H2 2021. Betaloc ZOK VBP was implemented in Q4 2022 | |
Onglyza | 257 | (28%) | (25%) | * Ongoing impact from VBP implementation | |
Bydureon | 280 | (27%) | (26%) | * Continued competitive pressures | |
Other CVRM | 366 | (10%) | (7%) |
BioPharmaceuticals - R&I
Total Revenue of $5,963m from R&I medicines in FY 2022 decreased 1% (increased 3% at CER) and represented 13% of overall Total Revenue (FY 2021: 16%). This reflected growth in recently launched brands, including Fasenra, Tezspire, Breztri and Saphnelo, offset by the erosion of Pulmicort revenue following its inclusion in VBP in China in Q4 2021, and a smaller decline in Symbicort revenue.
Symbicort
Total Revenue | Worldwide | Emerging Markets | US | Europe | Established RoW | ||
FY 2022 $m | 2,538 | 608 | 973 | 582 | 375 | ||
Actual change | (7%) | - | (9%) | (13%) | (2%) | ||
CER change | (2%) | 5% | (9%) | (3%) | 5% |
Region | Drivers and commentary | |
Worldwide | * Symbicort remains the global market leader within a stable ICS[50]/LABA[51] class | |
Emerging Markets | * Growth driven primarily by Latin America, Middle East and Asia Area, offset by decrease in China due to COVID-19 restrictions | |
US | * Strong market share performance, consolidating leadership in a declining ICS/LABA market, offset by pricing pressure | |
Europe | * Resilient market share in growing ICS/LABA market, offset by pricing pressure | |
Established RoW | * Growth in some countries driven by share gains and a continued recovery in the ICS/LABA market. That growth was offset by generic erosion in other countries |
Fasenra
Total Revenue | Worldwide | Emerging Markets | US | Europe | Established RoW | ||
FY 2022 $m | 1,396 | 43 | 906 | 305 | 142 | ||
Actual change | 11% | >2x | 15% | 7% | (12%) | ||
CER change | 15% | >2x | 15% | 20% | (1%) |
Region | Drivers and commentary | |
Worldwide | * Fasenra continues to be market leader in severe eosinophilic asthma in major markets, and leading in the IL-5[52] class | |
Emerging Markets | * Strong volume growth driven by launch acceleration across key markets | |
US | * Maintained a strong total patient share in the severe asthma market | |
Europe | * Sustained growth by expanding leadership in severe eosinophilic asthma | |
Established RoW | * Maintained market leadership in Japan, partially offset by price adjustments and impact in the dynamic market[53] related to the rise in COVID-19 cases |
Breztri
Total Revenue | Worldwide | Emerging Markets | US | Europe | Established RoW | ||
FY 2022 $m | 398 | 92 | 239 | 33 | 34 | ||
Actual change | 96% | 68% | >2x | >4x | 32% | ||
CER change | >2x | 75% | >2x | >5x | 56% |
Region | Drivers and commentary | |
Worldwide | * Breztri continued to gain market share within the growing FDC[54] triple class across major markets | |
Emerging Markets | * In China, the FDC triple class continued to penetrate the inhaled maintenance market, with growth impacted by COVID-19. Breztri continued its market share leadership within the fixed-dose triple class | |
US | * Consistent new-to-brand[55] and total market share growth within the FDC triple class | |
Europe | * Sustained growth across markets as new launches continue to progress | |
Established RoW | * Strong new-to-brand market share performance in Japan, with the dynamic market impacted by access restrictions related to the rise in COVID-19 cases |
Saphnelo
Total Revenue of $116m in the year (FY 2021: $8m) was driven by demand acceleration in the US, where Saphnelo achieved new-to-brand leadership in the i.v.[56] segment for SLE[57] and received a permanent J-code facilitating reimbursement. Growth was further supported by launches in Germany and Japan during the year.
Tezspire
Tezspire is approved in the US, EU and Japan (as well as other countries) for the treatment of severe asthma without biomarker or phenotypic limitation. Collaboration Revenue of $82m in the year (FY 2021: $nil) reflected the strong early launch performance in the US. In Europe and Established RoW, AstraZeneca recorded $4m revenue ($2m in each region).
Amgen records sales in the US and AstraZeneca records its share of gross profits in the US as Collaboration Revenue. Total ex-US product sales are recorded as AstraZeneca revenue ($4m in 2022). Global in-market sales of Tezspire were $174m in 2022.
Other R&I medicines
FY 2022 | % Change |
Total Revenue | $m | Actual | CER | ||
Pulmicort |
| 645 | (33%) | (31%) | * Emerging Markets revenue decreased 40% (39% at CER) to $462m, impacted by VBP implementation in China, lower rates of hospitalisations and limited access to nebulisation centres in China due to COVID-19 lockdowns * Revenues in Ex-China Emerging Markets grew following recovery of nebulisation demand |
Daliresp/Daxas |
| 189 | (17%) | (16%) | * Impacted by uptake of multiple generics following loss of exclusivity in the US * Total Revenue in the fourth quarter decreased by 52% |
Bevespi | 58 | 7% | 9% | ||
Other R&I | 540 | (11%) | (9%) | * Collaboration Revenue of $119m (FY 2021: $15m), including $110m of milestones relating to tralokinumab (FY 2021: $nil) * Product Sales of $421m decreased 29% (27% at CER) |
BioPharmaceuticals - V&I
Total Revenue from V&I medicines was broadly flat at $4,836m (FY 2021: $4,779m) and represented 11% of overall Total Revenue (FY 2021: 13%).
Vaxzevria
Total Revenue | Worldwide | Emerging Markets | US | Europe | Established RoW | ||
FY 2022 $m | 1,875 | 805 | 79 | 365 | 625 | ||
Actual change | (53%) | (65%) | 24% | (65%) | 8% | ||
CER change | (51%) | (65%) | 24% | (61%) | 17% |
Region | Drivers and commentary | |
Worldwide | * Revenue in the fourth quarter decreased by 95% (94% at CER) due to the conclusion of Vaxzevria contracts | |
Emerging Markets | * $76m of Collaboration Revenue from sub-licensees in FY 2022, including $46m in Q1 2022 from a Chinese sub-licensee producing vaccines for export * Revenue in the fourth quarter decreased by 95% | |
US | * Purchases by the US Government for donation overseas in Q1 2022 * No revenue was recorded after Q1 2022 | |
Europe | * Revenue in the fourth quarter decreased by 87% (84% at CER) vs Q4 2021 | |
Established RoW | * No revenue was recorded for Established RoW in the fourth quarter |
Evusheld
Total Revenue | Worldwide | Emerging Markets | US | Europe | Established RoW | ||
FY 2022 $m | 2,184 | 413 | 1,067 | 298 | 407 | ||
Actual change | >10x | >6x | n/m | >4x | n/m | ||
CER change | >10x | >6x | n/m | >5x | n/m |
Region | Drivers and commentary | |
US | * AstraZeneca fulfilled the US Government's order for 1.7 million units during the year | |
Emerging Markets | * Government contracts in Central and Eastern Europe, Latin America and South East Asia | |
Europe | * Approved in the EU for prevention of COVID-19 in March 2022 and treatment of COVID-19 in September 2022 | |
Established RoW | * Approved in Japan for prevention and treatment of COVID-19 in August 2022 |
Other V&I medicines
FY 2022 | % Change |
Total Revenue | $m | Actual | CER | ||
Synagis |
| 578 | 41% | 59% | * Ex-US rights reverted to AstraZeneca after 30 June 2021, from AbbVie Inc. * In Q4 2022, Synagis sales decreased by 19% (3% CER), reflecting the early start to the RSV season in the prior year period |
FluMist | 175 | (31%) | (20%) | * Late start to the influenza season in Europe |
Rare Disease
On a pro forma basis, Total Revenue from Rare Disease medicines increased by 4% (10% at CER) in FY 2022 to $7,053m, representing 16% of overall Total Revenue.
Performance was driven by the durability of the C5[58] franchise, Soliris and Ultomiris growth in neurology indications, Ultomiris gMG launch, and expansion into new markets.
Strensiq and Koselugo performances were driven by continued patient demand and geographic expansion.
These tables show pro forma growth rates for each of the medicines acquired with Alexion, calculated by comparing FY 2022 revenues with the medicine's revenues from 1 January 2021 to 31 December 2021.
Soliris
Total Revenue | Worldwide | Emerging Markets | US | Europe | Established RoW | ||
FY 2022 $m | 3,762 | 301 | 2,180 | 805 | 476 | ||
Actual change6 | (11%) | (29%) | (7%) | (21%) | 11% | ||
CER change6 | (5%) | (10%) | (7%) | (12%) | 24% |
Region | Drivers and commentary | |
US | * Performance impacted by successful conversion to Ultomiris in PNH[59], aHUS[60] and gMG[61], partially offset by Soliris growth in NMOSD | |
Ex-US | * Decline driven by successful conversion to Ultomiris, slightly offset by growth in NMOSD and expansion in new markets |
Ultomiris
Total Revenue | Worldwide | Emerging Markets | US | Europe | Established RoW | ||
FY 2022 $m | 1,965 | 38 | 1,136 | 481 | 310 | ||
Actual change6 | 34% | >2x | 35% | 49% | 6% | ||
CER change6 | 42% | >2x | 35% | 68% | 26% |
Region | Drivers and commentary | |
Worldwide | * Performance driven by gMG launch in the US and expansion into new markets * Quarter-on-quarter variability in revenue growth can be expected due to Ultomiris every eight-week dosing schedule and lower average annual treatment cost per patient compared to Soliris | |
US | * Performance driven by successful conversion from Soliris across PNH, aHUS and gMG | |
Europe | * Growth driven by strong demand generation following new launch markets | |
Established RoW | * Rapid conversion in new launch markets, strong growth in Japan following gMG launch |
Other Rare Disease medicines
FY 2022 | % Change |
Total Revenue | $m | Actual | CER | Commentary | |
Strensiq |
| 958 | 16% | 18% | * Performance driven by strong patient demand and geographic expansion |
Koselugo | 208 | 93% | 96% | * Growth driven by expansion in new markets | |
Kanuma | 160 | 16% | 19% | * Continued demand growth in ex-US markets |
Other medicines (outside the main therapy areas)
FY 2022 | % Change |
Total Revenue | $m | Actual | CER | Commentary | |
Nexium |
| 1,367 | (4%) | 7% | * Nexium (oral) was implemented in China's VBP programme in February 2021 and Nexium i.v. was implemented in October 2021 * Generic competition in Japan increased in the fourth quarter |
Others | 381 | (4%) | (1%) |
Financial performance
Table 9: Reported Profit and Loss
FY 2022 | FY 2021 | % Change | Q4 2022 | Q4 2021 | % Change |
| ||||
|
| $m | $m | Actual | CER | $m | $m | Actual | CER | |
Total Revenue |
| 44,351 | 37,417 | 19 | 25 | 11,207 | 12,011 | (7) | 1 | |
- Product Sales | 42,998 | 36,541 | 18 | 24 | 10,798 | 11,498 | (6) | 2 | ||
- Collaboration Revenue | 1,353 | 876 | 54 | 56 | 409 | 513 | (20) | (19) | ||
Cost of sales | (12,391) | (12,437) | - | 4 | (2,900) | (4,625) | (37) | (35) | ||
Gross profit |
| 31,960 | 24,980 | 28 | 35 | 8,307 | 7,386 | 12 | 24 | |
Gross Margin |
| 71.2% | 66.0% | +5pp | +5pp | 73.1% | 59.8% | +13pp | +15pp | |
Distribution expense | (536) | (446) | 20 | 29 | (156) | (124) | 26 | 38 | ||
% Total Revenue | 1.2% | 1.2% | - | - | 1.4% | 1.0% | - | - | ||
R&D expense | (9,762) | (9,736) | - | 5 | (2,625) | (2,584) | 2 | 9 | ||
% Total Revenue | 22.0% | 26.0% | +4pp | +4pp | 23.4% | 21.5% | -2pp | -2pp | ||
SG&A expense | (18,419) | (15,234) | 21 | 26 | (4,621) | (5,117) | (10) | (3) | ||
% Total Revenue | 41.5% | 40.7% | -1pp | - | 41.2% | 42.6% | +1pp | +2pp | ||
OOI[62] & expense | 514 | 1,492 | (66) | (65) | 189 | 147 | 29 | 33 | ||
% Total Revenue | 1.2% | 4.0% | -3pp | -3pp | 1.7% | 1.2% | - | - | ||
Operating profit/(loss) |
| 3,757 | 1,056 | >3x | >3x | 1,094 | (292) | n/m | n/m | |
Operating Margin |
| 8.5% | 2.8% | 6 | 7 | 9.8% | -2.4% | +12pp | +14pp | |
Net finance expense | (1,251) | (1,257) | (1) | 5 | (315) | (335) | (6) | - | ||
Joint ventures and associates | (5) | (64) | (92) | (91) | (1) | (9) | (89) | (89) | ||
Profit/(loss) before tax |
| 2,501 | (265) | n/m | n/m | 778 | (636) | n/m | n/m | |
Taxation | 792 | 380 | >2x | >3x | 124 | 290 | (57) | 21 | ||
Tax rate |
| -32% | 143% |
|
| -16% | 46% | |||
Profit/(loss) after tax |
| 3,293 | 115 | n/m | n/m | 902 | (346) | n/m | n/m | |
Earnings per share |
| $ 2.12 | $0.08 | n/m | n/m | $0.58 | $(0.22) | n/m | n/m | |
Table 10: Reconciliation of Reported Profit before tax to EBITDA
FY 2022 | FY 2021 | % Change | Q4 2022 | Q4 2021 | % Change | ||||
$m | $m | Actual | CER | $m | $m | Actual | CER | ||
Reported Profit/(loss) before tax | 2,501 | (265) | n/m | n/m | 778 | (636) | n/m | n/m | |
Net finance expense | 1,251 | 1,257 | (1) | 5 | 315 | 335 | (6) | - | |
Joint ventures and associates | 5 | 64 | (92) | (91) | 1 | 9 | (89) | (89) | |
Depreciation, amortisation and impairment | 5,480 | 6,530 | (16) | (12) | 1,480 | 2,192 | (32) | (28) | |
EBITDA | 9,237 | 7,586 | 22 | 33 | 2,574 | 1,900 | 36 | 56 | |
EBITDA of $9,237m in the year (FY 2021: $7,586m) has been negatively impacted by the $3,484m (FY 2021: $2,198m) unwind of inventory fair value uplift recognised on the acquisition of Alexion. EBITDA of $2,574m in the quarter (Q4 2021: $1,900m) has been negatively impacted by the $309m (Q4 2021: $1,154m) unwind of inventory fair value uplift recognised on the acquisition of Alexion. The unwind of the remaining $114m inventory fair value uplift is expected to depress EBITDA in 2023.
Table 11: Reconciliation of Reported to Core financial measures: FY 2022
FY 2022 | Reported | Restructuring | Intangible Asset Amortisation & Impairments | Acquisitionof Alexion | Other | Core | Core % Change |
$m | $m | $m | $m | $m | $m | Actual | CER | ||
Gross profit |
| 31,960 | 266 | 32 | 3,506 | (1) | 35,763 | 28 | 35 |
Gross Margin |
| 71.2% |
|
|
|
| 80.0% | +6pp | +6pp |
Distribution expense | (536) | 2 | - | - | - | (534) | 20 | 28 | |
R&D expense | (9,762) | 111 | 124 | 27 | - | (9,500) | 19 | 24 | |
SG&A expense | (18,419) | 405 | 4,165 | 38 | 985[63] | (12,826) | 15 | 21 | |
Total operating expense | (28,717) | 518 | 4,289 | 65 | 985 | (22,860) | 17 | 23 | |
Other operating income & expense | 514 | (67) | - | - | - | 447 | (70) | (69) | |
Operating profit |
| 3,757 | 717 | 4,321 | 3,571 | 984 | 13,350 | 34 | 42 |
Operating Margin |
| 8.5% |
|
|
|
| 30.1% | +4pp | +4pp |
Net finance expense | (1,251) | - | - | - | 277 | (974) | 13 | 18 | |
Taxation | 792 | (165) | (804) | (832) | (1,049)[64] | (2,058) | 38 | 46 | |
EPS |
| $2.12 | $0.36 | $2.27 | $1.77 | $0.14 | $6.66 | 26 | 33 |
Table 12: Reconciliation of Reported to Core financial measures: Q4 2022
Q4 2022 | Reported | Restructuring | Intangible Asset Amortisation & Impairments | Acquisitionof Alexion | Other | Core | Core % Change |
$m | $m | $m | $m | $m | $m | Actual | CER | ||
Gross profit |
| 8,307 | 110 | 8 | 320 | - | 8,745 | (3) | 6 |
Gross Margin |
| 73.1% |
|
|
|
| 77.2% | +3pp | +4pp |
Distribution Expense | (156) | - | - | - | - | (156) | 27 | 39 | |
R&D expense | (2,625) | 54 | 41 | 4 | - | (2,526) | 5 | 12 | |
SG&A expense | (4,621) | 142 | 1,105 | 3 | (212) | (3,583) | 6 | 15 | |
Total operating expense | (7,402) | 196 | 1,146 | 7 | (212) | (6,265) | 6 | 14 | |
Other operating income & expense | 189 | (59) | - | - | - | 130 | (11) | (7) | |
Operating profit |
| 1,094 | 247 | 1,154 | 327 | (212) | 2,610 | (21) | (10) |
Operating Margin |
| 9.8% |
|
|
|
| 23.3% | -4pp | -3pp |
Net finance expense | (315) | - | - | - | 70 | (245) | 5 | 9 | |
Taxation | 124 | (72) | (223) | (84) | 29 | (226) | (55) | (44) | |
EPS |
| $0.58 | $0.11 | $0.60 | $0.16 | ($0.07) | $1.38 | (17) | (5) |
Profit and Loss drivers
Gross profit
‒ The Gross Margin (Reported and Core) in the year was impacted by:
‒ Positive mix effects: the increased contribution from Rare Disease and Oncology medicines had a positive impact on the Gross Margin
‒ Negative mix effects: sales of Vaxzevria and medicines with profit-sharing arrangements (primarily Lynparza) had a dilutive impact on the Gross Margin
‒ Inventory write downs and provisions for excess manufacturing reservation fees relating to Evusheld
‒ Pricing pressure relating to procurement programmes in China
‒ Reported Gross Profit was also impacted by the unwind of the fair value adjustment to Alexion inventories at the date of acquisition. The fair value uplift is expected to unwind through Reported Cost of sales in line with associated revenues, and in FY 2022, the impact of the fair value uplift unwind on Cost of sales was $3,484m (FY 2021: $2,198m)
‒ Currency fluctuations had a small positive impact on Gross Margin in the year. Currency fluctuations may have a positive or negative impact on Gross Margin in future quarters
‒ Variations in Gross Margin performance between periods can be expected to continue
R&D expense
‒ The increase in Reported and Core R&D expense was impacted by:
‒ The acquisition of Alexion in July 2021
‒ Recent positive data read outs for several high priority medicines that ungated late-stage Oncology trials
‒ The advancement of a number of mid-stage clinical development programmes in BioPharmaceuticals
‒ Investment in platforms, new technology and capabilities to enhance R&D productivity
SG&A expense
‒ The increase in Reported and Core SG&A expense was driven by:
‒ The acquisition of Alexion in July 2021
‒ Market development activities for launches
‒ Reported SG&A expense was also impacted by amortisation of intangible assets related to the Alexion acquisition and other acquisitions and collaborations, and a $775m legal settlement with Chugai
Other operating income
‒ Reported Other operating income of $514m consisted primarily of disposal proceeds on small divestments, including the divestment of rights to Plendil in the second quarter, disposal proceeds on sale of tangible assets, and royalties
‒ In FY 2021, Reported Other operating income of $1,492m included $776m of divestment gains from AstraZeneca's share of Viela Bio, Inc. and $317m from the divestment of commercial rights to Crestor in over 30 countries in Europe (excluding UK and Spain)
Net finance expense
‒ The change in Reported and Core Net finance expense in the year was primarily driven by financing costs on debt for the Alexion transaction. Reported Net finance expense was also impacted by a reduction in the discount unwind on acquisition-related liabilities, including the Diabetes Alliance
Taxation
‒ The effective Reported Tax Rate for the year was -32% (FY 2021: 143%) and the Core Tax rate was 17% (FY 2021: 17%)
‒ The Reported Tax Rate for the year included a one-time favourable net adjustment of $876m to deferred taxes arising from an internal reorganisation to integrate the Alexion organisation which took place in the third quarter. The internal legal entity reorganisation did not result in any corporate income tax becoming payable in the year, however it did result in a one-off deferred tax adjustment of $876m to the income statement, and a further $49m credit associated with the reorganisation is included in Other Comprehensive Income. Following the reorganisation, it was necessary to re-measure certain deferred tax balances to reflect the tax rates applicable on their reversal as under the revised structure there is a change in the income flows to the relevant territories
‒ The Reported Tax rate of -32% was lower than the Core Tax Rate of 17% primarily due to the impact of the aforementioned internal restructuring. The 2022 Reported and Core Tax rates also benefited from IP incentive regimes, geographical mix of profits and net favourable adjustments to prior year tax liabilities in a number of major jurisdictions, many of which were one-time items
‒ 2021 Reported and Core Tax rates were impacted by one-off items in 2021, including the non-taxable gain on the divestment of Viela Bio, Inc and updates to estimates of prior period tax liabilities following settlements with tax authorities
‒ The net cash paid for the year was $1,623m (2021: $1,743m) representing 65% of Reported Profit before tax (2021: -658%). The cash tax amount decreased due to refunds received in the year relating to prior periods and phasing of payments between current and future years
‒ On 20 July 2022, the UK Government issued draft legislation in relation to the new global minimum tax framework, expected to be brought into effect in the UK from 2024. The UK corporation tax rate continues to be expected to increase to 25%, effective April 2023. The Company is currently assessing the potential impact of these draft rules upon its financial statements
Dividend per share
‒ A second interim dividend of $1.97 per share (162.8 pence, 20.69 SEK) has been declared, meaning a full-year dividend per share of $2.90 (239.2 pence, 30.18 SEK). Dividend payments are normally paid as follows:
‒ First interim dividend - announced with half-year and second-quarter results and paid in September
‒ Second interim dividend - announced with full-year and fourth-quarter results and paid in March
‒ The record date for the second interim dividend for 2022, payable on 27 March 2023, will be 24 February 2023. The ex-dividend date will be 23 February 2023. The record date for the first interim dividend for 2023, payable on 11 September 2023, will be 11 August 2023. The ex-dividend date will be 10 August 2023.
Table 13: Cash Flow summary
FY 2022 | FY 2021 | Change | ||
$m | $m | $m | ||
Reported Operating Profit | 3,757 | 1,056 | 2,701 | |
Depreciation, Amortisation and Impairment | 5,480 | 6,530 | (1,050) | |
Decrease in Working Capital and Short-term Provisions | 3,757 | 2,021 | 1,736 | |
Gains on Disposal of Intangible Assets | (104) | (513) | 409 | |
Gains on Disposal of Investments in Associates and Joint Ventures | - | (776) | 776 | |
Fair value movements on contingent consideration arising from business combinations | 82 | 14 | 68 | |
Non-Cash and Other Movements | (692) | 95 | (787) | |
Interest Paid | (849) | (721) | (128) | |
Taxation Paid | (1,623) | (1,743) | 120 | |
Net Cash Inflow from Operating Activities | 9,808 | 5,963 | 3,845 | |
Net Cash Inflow/(Outflow) before Financing Activities | 6,848 | (5,095) | 11,943 | |
Net Cash (Outflow)/Inflow from Financing Activities | (6,823) | 3,649 | (10,472) |
The increase in Net Cash Inflow from Operating Activities of $3,845m primarily reflects an underlyingimprovement in business performance, including the contribution from Alexion for the full year.
The Reported Operating Profit of $3,757m in the year includes a negative impact of $3,484m relating to the unwind of the inventory fair value uplift recognised on the acquisition of Alexion. The corresponding positive impact of $3,484m in Decrease in Working Capital and Short-term Provisions offsets the negative impact on Reported Operating Profit. Overall, the unwind of the fair value uplift has no impact on Net Cash Inflow from Operating Activities.
The change in Working Capital and Short-term Provisions of $1,736m, whilst being positively impacted by the aforementioned inventory fair value uplift unwind, has been adversely impacted by the reduction of Vaxzevria working capital balances predominantly within Trade and other payables.
The change in Non-Cash and Other Movements of ($787m) is primarily driven by changes in non-current Provisions, as well as increased foreign exchange volatility on intercompany transactions.
Capital Expenditure
Capital Expenditure amounted to $1,091m in the year (FY 2021: $1,091m) including expenditure relating to Alexion.
Table 14: Net Debt summary
| At 31 Dec 2022 | At 31 Dec 2021 | |
| $m | $m | |
Cash and cash equivalents | 6,166 | 6,329 | |
Other investments | 239 | 69 | |
Cash and investments |
| 6,405 | 6,398 |
Overdrafts and short-term borrowings | (350) | (387) | |
Lease liabilities | (953) | (987) | |
Current instalments of loans | (4,964) | (1,273) | |
Non-current instalments of loans | (22,965) | (28,134) | |
Interest-bearing loans and borrowings (Gross Debt) |
| (29,232) | (30,781) |
Net derivatives | (96) | 61 | |
Net Debt |
| (22,923) | (24,322) |
Net Debt decreased by $1,399m in the year to $22,923m. Details of the committed undrawn bank facilities are disclosed within the going concern section of Note 1. Details of the Company's solicited credit ratings are disclosed in Note 3.
Capital allocation
The Board's aim is to continue to strike a balance between the interests of the business, financial creditors and the Company's shareholders. The Company's capital allocation priorities include: investing in the business and pipeline; maintaining a strong, investment-grade credit rating; potential value-enhancing business development opportunities; and supporting the progressive dividend policy.
In approving the declaration of dividends, the Board considers both the liquidity of the company and the level of reserves legally available for distribution. Dividends are paid to shareholders from AstraZeneca PLC, a Group holding company with no direct operations. The ability of AstraZeneca PLC to make shareholder distributions is dependent on the creation of profits for distribution and the receipt of funds from subsidiary companies. The consolidated Group reserves set out in the Condensed consolidated statement of financial position do not reflect the profit available for distribution to the shareholders of AstraZeneca PLC.
Summarised financial information for guarantee of securities of subsidiaries
AstraZeneca Finance LLC ("AstraZeneca Finance") is the issuer of 0.700% Notes due 2024, 1.200% Notes due 2026, 1.750% Notes due 2028 and 2.250% Notes due 2031 (the "AstraZeneca Finance Notes"). Each series of AstraZeneca Finance Notes has been fully and unconditionally guaranteed by AstraZeneca PLC. AstraZeneca Finance is 100% owned by AstraZeneca PLC and each of the guarantees by AstraZeneca PLC is full and unconditional and joint and several.
The AstraZeneca Finance Notes are senior unsecured obligations of AstraZeneca Finance and rank equally with all of AstraZeneca Finance's existing and future senior unsecured and unsubordinated indebtedness. The guarantee by AstraZeneca PLC of the AstraZeneca Finance Notes is the senior unsecured obligation of AstraZeneca PLC and ranks equally with all of AstraZeneca PLC's existing and future senior unsecured and unsubordinated indebtedness. Each guarantee by AstraZeneca PLC is effectively subordinated to any secured indebtedness of AstraZeneca PLC to the extent of the value of the assets securing such indebtedness. The AstraZeneca Finance Notes are structurally subordinated to indebtedness and other liabilities of the subsidiaries of AstraZeneca PLC, none of which guarantee the AstraZeneca Finance Notes.
AstraZeneca PLC manages substantially all of its operations through divisions, branches and/or investments in subsidiaries and affiliates. Accordingly, the ability of AstraZeneca PLC to service its debt and guarantee obligations is also dependent upon the earnings of its subsidiaries, affiliates, branches and divisions, whether by dividends, distributions, loans or otherwise.
Please refer to the consolidated financial statements of AstraZeneca PLC in our Annual Report on Form 20-F and reports on Form 6-K with our quarterly financial results as filed or furnished with the SEC[65] for further financial information regarding AstraZeneca PLC and its consolidated subsidiaries. For further details, terms and conditions of the AstraZeneca Finance Notes please refer to AstraZeneca PLC's Form 6-K furnished to the SEC on 28 May 2021.
Pursuant to Rule 13-01 and Rule 3-10 of Regulation S-X under the Securities Act of 1933, as amended (the "Securities Act"), we present below the summary financial information for AstraZeneca PLC, as Guarantor, excluding its consolidated subsidiaries, and AstraZeneca Finance, as the issuer, excluding its consolidated subsidiaries. The following summary financial information of AstraZeneca PLC and AstraZeneca Finance is presented on a combined basis and transactions between the combining entities have been eliminated. Financial information for non-guarantor entities has been excluded. Intercompany balances and transactions between the obligor group and the non-obligor subsidiaries are presented on separate lines.
Table 15: Obligor group summarised Statement of comprehensive income
| FY 2022 | |
| $m | |
Total Revenue | - | |
Gross Profit | - | |
Operating loss | (27) | |
Loss for the period | (687) | |
Transactions with subsidiaries that are not issuers or guarantors | 1,071 |
Table 16: Obligor group summarised Statement of financial position
| At 31 Dec 2022 | |
| $m | |
Current assets | 4 | |
Non-current assets | - | |
Current liabilities | (2,839) | |
Non-current liabilities | (22,797) | |
Amounts due from subsidiaries that are not issuers or guarantors | 7,806 | |
Amounts due to subsidiaries that are not issuers or guarantors | (293) |
Foreign exchange
The Company's transactional currency exposures on working-capital balances, which typically extend for up to three months, are hedged where practicable using forward foreign exchange contracts against the individual companies' reporting currency. Foreign exchange gains and losses on forward contracts for transactional hedging are taken to profit or loss. In addition, the Company's external dividend payments, paid principally in pounds sterling and Swedish krona, are fully hedged from announcement to payment date.
Table 17: Currency sensitivities
The Company provides the following currency-sensitivity information:
| Average spot rates vs. USD | Annual impact of 5% strengthening inFY average rate vs. USD ($m) [66] |
Currency | Primary Relevance |
| FY 2022[67] | Jan 2023[68] | Change (%) |
| Total Revenue | Core Operating Profit |
EUR | Total Revenue | 0.95 | 0.93 | 2 | 323 | 159 | ||
CNY | Total Revenue | 6.74 | 6.79 | (1) | 309 | 174 | ||
JPY | Total Revenue | 131.59 | 130.37 | 1 | 181 | 122 | ||
Other[69] | 385 | 202 | ||||||
GBP | Operating expense | 0.81 | 0.82 | (1) | 46 | (92) | ||
SEK | Operating expense | 10.12 | 10.39 | (3) | 7 | (55) |
Sustainability
Since the last quarterly report, AstraZeneca:
Access to healthcare
‒ Presented the main findings of health system research conducted by the Partnership for Health System Sustainability and Resilience (PHSSR), which the Company co-founded, at the second Global PHSSR Summit in November. The results highlighted key themes across workforce and health service delivery, finance and governance, and the role of technology in strengthening health systems, as well as the importance of prevention and early intervention in non-communicable diseases
‒ Achieved third position overall in the 2022 Access to Medicine Index and was recognised as the industry leader in Product Delivery, including for its application of tailored access strategies for countries reflecting their income classifications across all product categories. The Company's approach to patent transparency and sharing of intellectual property assets, using technology transfers, was also highlighted as key to ensuring continuous supply of medicines in low- and middle-income countries. It also performed well in the Governance of Access and Research & Development categories
‒ Chair Leif Johansson alongside Senior Executive Team members Marc Dunoyer, Dave Fredrickson and Iskra Reic attended the World Economic Forum (WEF) in Davos in January 2023, for engagements with global, regional and national leaders. The Company focused on investing in health as the foundation of strong and resilient societies, and the need for collective early action to build more sustainable and equitable healthcare systems, including through collaborations such as the PHSSR and Sustainable Markets Initiative (SMI). AstraZeneca hosted a high-level roundtable on investing in non-communicable diseases attended by global health leaders, and signed the Zero Health Gaps Pledge in support of the WEF Global Health Equity Network vision to advance health equity
‒ Committed to expand the Healthy Heart Africa programme into 10 countries over two years, starting in 2023, in addition to the nine countries where the programme is currently active. Over 32 million blood pressure screenings have been conducted since launch in 2015 and over 10,600 healthcare workers trained, as at end of December 2022
‒ Reached more than nine million young people through the Young Health Programme with health information and trained more than 260,000 young people as peer educators in 39 countries, by end of December 2022
Environmental protection
‒ CEO Pascal Soriot hosted a high-level engagement on climate and health at COP27, in his capacity as champion of the SMI Health Systems Task Force, which made sector-first commitments, actions and recommendations to deliver near-term targets and support the transition to net-zero sustainable healthcare. The Company also launched new commitments during COP27 in support of its Ambition Zero Carbon strategy
‒ Achieved a double-A rating for Climate Change and Water Security from CDP for the seventh consecutive year, and an improved Forest score of B for timber, B for palm oil and C for cattle products. AstraZeneca received a CDP UK Leadership Award in recognition of the double-A rating and commitment to environmental transparency. AZ Forest has also published a pledge implementation update report
‒ Achieved a 100% electric vehicle fleet in the Netherlands, the first Company location to do so, as part of the fleet decarbonisation strategy to support Ambition Zero Carbon emissions reduction targets
‒ Earned the US Environmental Protection Agency's ENERGY STAR® certification for superior energy efficiency for the Company's Wilmington, US site, which is more energy-efficient than 85 percent of similar properties nationwide
Ethics and transparency
‒ Featured in the latest Dow Jones Sustainability Index Series and the Corporate Knights list of the Global 100 world's most sustainable corporations
‒ Marked International Day of People with Disabilities on 3 December, which aims to promote an understanding of disability issues with an emphasis on accessibility, including with an article on Accessibility in the workplace: the importance of allyship, highlighting key themes such as access to technology
‒ Featured in the 2023 Bloomberg Gender-Equality Index, for the fifth consecutive year, recognising the Company's continued commitment to gender equality and transparency
Research and development
This section covers R&D events and milestones that have occurred since the prior results announcement on 10 November 2022, up to and including events on 8 February 2023.
A comprehensive view of AstraZeneca's pipeline of medicines in human trials can be found in the latest clinical trials appendix, available on www.astrazeneca.com/investor-relations. The clinical trials appendix includes tables with details of the ongoing clinical trials for AstraZeneca medicines and new molecular entities in the pipeline.
Oncology
AstraZeneca presented new data across its diverse portfolio of cancer medicines at two major medical congresses during the quarter: the 2022 San Antonio Breast Cancer Symposium (SABCS) and the 64th American Society of Hematology (ASH), both in December. At SABCS, AstraZeneca presented 56 abstracts spanning five approved medicines and seven pipeline medicines with four late-breaking oral presentations. At ASH, AstraZeneca presented 47 abstracts showcasing new data across its haematology portfolio and clinical pipeline.
Significant new trials that achieved first patient dosed during the period included:
‒ TROPION-Breast03, a Phase III trial of datopotamab deruxtecan with or without Imfinzi for patients with Stage I-III triple negative breast cancer
‒ AVANZAR, a Phase III trial of datopotamab deruxtecan in combination with Imfinzi and chemotherapy for 1st-line NSCLC regardless of histology and PD-L1 expression
Tagrisso and savolitinib
Event | Commentary | ||
Fast Track Designation | US | Tagrisso in combination with savolitinib for the treatment of patients with locally advanced or metastatic NSCLC whose tumours have MET overexpression and/or amplification, as detected by an FDA-approved test, and who have had disease progression during or following prior Tagrisso. |
Imfinzi and Imjudo (tremelimumab)
Event | Commentary | ||
Approval | US |
| Imfinzi in combination with Imjudo plus platinum-based chemotherapy for the treatment of adult patients with Stage IV NSCLC with no sensitising EGFR[70] mutations or anaplastic lymphoma kinase. (POSEIDON, November 2022)
|
Approval | EU |
| Imfinzi for the 1st-line treatment of adult patients with unresectable or metastatic BTC in combination with chemotherapy. (TOPAZ-1, December 2022)
|
Approval | JP |
| Imfinzi with or without Imjudo for the treatment of adult patients with unresectable HCC. (HIMALAYA, December 2022)
Imfinzi for the treatment of adult patients with curatively unresectable BTC in combination with chemotherapy. (TOPAZ-1, December 2022)
Imfinzi for the treatment of adult patients with unresectable, advanced or recurrent NSCLC in combination with chemotherapy. (POSEIDON, December 2022) |
Read-out
| PEARL Phase III trial | The PEARL Phase III trial for Imfinzi did not achieve statistical significance for the primary endpoints of improving overall survival versus platinum-based chemotherapy as a monotherapy for the treatment of patients with Stage IV NSCLC whose tumour cells express high levels (25% or more) of PD-L1[71], or in a subgroup of patients at low risk of early mortality. (December 2022)
|
Lynparza
Event | Commentary | ||
Approval | EU | Lynparza in combination with abiraterone for the treatment of mCRPC in adult men for whom chemotherapy is not clinically indicated. (PROpel, December 2022)
| |
PDUFA[72] date change | US | The FDA indicated it will extend the PDUFA date by three months to March 2023 in order to provide further time for a full review of the sNDA[73] for Lynparza in combination with abiraterone for the treatment of mCRPC. (PROpel, December 2022)
|
Calquence
Event | Commentary | ||
Presentation: ASH | Real-world evidence and long-term follow-up data
| Real-world evidence and long-term follow-up data support consistent efficacy and safety profile of Calquence. | |
Approval | JP | Calquence for the treatment of adult patients with treatment-naïve chronic lymphocytic leukaemia (ELEVATE-TN) | |
CHMP positive opinion | EU | Maleate tablet formulation |
Enhertu
Event | Commentary | ||
Presentation: SABCS | DESTINY-Breast03 Phase III trial |
| Updated OS[74] results from the DESTINY-Breast03 Phase III trial, presented at SABCS 2022, demonstrated Enhertu statistically significant and clinically meaningful improvement in OS compared to T-DM1[75] in patients with HER2‑positive unresectable and/or metastatic breast cancer.
|
DESTINY-Breast02 Phase III trial
|
| Primary results from the DESTINY-Breast02 Phase III trial demonstrated clinical benefit of Enhertu compared to conventional chemotherapy-based regimens in patients with HER2-positive metastatic breast cancer previously treated with T‑DM1.
| |
Approval | EU | Enhertu for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received prior trastuzumab-based regimen, based on DESTINY-Gastric02 and DESTINY-Gastric01 trials. (December 2022)
|
Datopotamab deruxtecan (Dato-DXd)
Event | Commentary | ||
Presentation: SABCS | TROPION-PanTumor01 Phase I trial | Initial results from the TROPION-PanTumor01 Phase I trial showed encouraging and durable efficacy of Dato‑DXd in patients with heavily pre-treated HR-positive, HER2-low or HER2-negative unresectable or metastatic breast cancer. In this cohort, Dato-DXd demonstrated an objective response rate of 27% as assessed by blinded independent central review. All responses were partial and 56% of patients achieved stable disease. The disease control rate was 85% and median PFS was 8.3 months.
Updated results from the TROPION-PanTumor01 Phase I trial demonstrated Dato‑DXd continued to demonstrate encouraging responses in patients with heavily pretreated metastatic TNBC and disease progression following standard treatment.
In the TNBC cohort, Dato‑DXd demonstrated an ORR[76] of 32% including one complete response, 13 partial responses and 18 cases of stable disease as assessed by blinded independent central review. In the overall cohort, Dato‑DXd demonstrated median PFS of 4.4 months and median OS of 13.5 months. (December 2022) |
Camizestrant
Event | Commentary | ||
Presentation: SABCS | SERENA-2 Phase II trial | Detailed results from the SERENA-2 Phase II trial of camizestrant, AstraZeneca's next-generation oral selective oestrogen receptor degrader, were presented at SABCS 2022 and demonstrated statistically significant and clinically meaningful improvement in PFS at both 75mg and 150mg dose levels versus Faslodex (fulvestrant) in post-menopausal patients with ER-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy for advanced disease.
In the overall population, camizestrant significantly reduced risk of disease progression or death by 42% at a 75mg dose (based on HR of 0.58, 90% confidence interval) and mPFS of 7.2 versus 3.7 months and 33% at a 150mg dose (based on HR of 0.67, 90% confidence interval) and mPFS of 7.7 versus 3.7 months compared to Faslodex, the current SERD standard of care.
|
Capivasertib
Event | Commentary | ||
Presentation: SABCS | CAPItello-291 Phase III trial | Detailed results from the CAPItello-291 Phase III trial of capivasertib in combination with Faslodex demonstrated a statistically significant and clinically meaningful improvement in PFS versus placebo plus Faslodex in patients with HR-positive, HER2-low or negative, locally advanced or metastatic breast cancer following recurrence or progression on, or after, endocrine therapy (with or without a CDK4/6 inhibitor).
Capivasertib in combination with Faslodex demonstrated a 40% reduction in the risk of disease progression or death versus placebo plus Faslodex in the overall trial population (based on a HR of 0.60, 95% confidence interval) and median PFS 7.2 versus 3.6 months. In the AKT pathway biomarker-altered population, which affects up to 50% of patients with advanced HR-positive breast cancer, capivasertib plus Faslodex reduced risk of disease progression or death by 50% versus placebo plus Faslodex. |
BioPharmaceuticals - CVRM
Farxiga
Event | Commentary | ||
Approval | EU |
| Forxiga for heart failure with reduced ejection fraction to cover patients across the full spectrum of left ventricular ejection fraction including heart failure with mildly reduced and preserved ejection fraction. (DELIVER, February 2023)
|
BioPharmaceuticals - R&I
Significant new trials in R&I initiated since the previous results included:
‒ TILIA, a Phase III trial for tozorakimab in acute respiratory failure in patients with viral lung infection
Tezspire
Event | Commentary | ||
Approval | US, EU |
| The Tezspire pre-filled pen for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. (January, February 2023) |
Airsupra (PT027)
Event | Commentary | ||
Approval | US |
| Airsupra for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. This is the first approval for Airsupra, formerly known as PT027. (January 2023)
|
Saphnelo
Event | Commentary | ||
Orphan Drug Designation | US | Saphnelo for idiopathic inflammatory myopathies (including myositis), a group of diseases in which type I interferon plays a key role. (December 2022)
|
Fasenra
Event | Commentary | ||
Phase III trial discontinued | HUDSON | Eosinophilic gastritis (EG/EGE) trial discontinued due to strategic portfolio prioritisation. This discontinuation was not related to any safety or efficacy findings. (January 2023)
|
Tozorakimab
Event | Commentary | ||
Fast Track Designation | US |
| Tozorakimab to reduce the risk of invasive mechanical ventilation, extracorporeal membrane oxygenation or death (acute respiratory failure) in adults hospitalised with viral lung infection and requiring supplemental oxygen. (December) |
BioPharmaceuticals - V&I
A significant new trial commenced in the period:
‒ SUPERNOVA, a PhaseI/III trial to evaluate the safety and neutralising activity of AZD3152 for the prevention of symptomatic COVID-19 in adults and adolescents 12 years of age or older with conditions that cause immune impairment
SUPERNOVA was originally planned to evaluate a combination of AZD3152 and cilgavimab, one of the two monoclonal antibodies that make up Evusheld. In January 2023, the decision was taken to investigate AZD3152 alone, which has been shown to neutralise all known variants to date. AstraZeneca is aiming to make AZD3152 available as a new option for COVID-19 in the second half of 2023, subject to trial readouts and regulatory reviews.
In February 2023, AstraZeneca reached agreement with the U.S. Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), in collaboration with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, via the Medical CBRN Defense Consortium (MCDC) Other Transaction Agreement (OTA) to develop an RNA-based universal pandemic influenza prototype vaccine. As part of the resulting prototype project, AstraZeneca could receive up to approximately $80m over three years to develop the vaccine from preclinical research through a Phase I/II clinical study.
Evusheld
Event | Commentary | ||
Revision to Emergency Use Authorisation | US | The FDA has revised Evusheld's Emergency Use Authorisation to limit the use of Evusheld to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally in the US is ≤90%. (January 2023)
Evusheld is not currently authorised by the US FDA for pre-exposure prophylaxis of COVID-19 (as of January 2023), due to sustained high frequency of circulating SARS-CoV-2 variants against which Evusheld does not retain in vitro neutralisation.
|
Beyfortus
Event | Commentary | ||
Regulatory submission | US | Nirsevimab for prevention of lower respiratory tract disease in newborns and infants entering or during their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. (January 2023)
The FDA has indicated it will work to expedite its review. The PDUFA date is in the third quarter of 2023.
|
Rare Disease
A significant new trial achieved first patient dosed during the period:
‒ ALXN1720-MG-301, a Phase III trial of gefurulimab (ALXN1720), an anti-C5 albumin-binding humanised bispecific VHH antibody in gMG
Vemircopan (ALXN2050)
Event | Commentary | ||
Conference: ASH | PNH monotherapy Phase II trial | An oral presentation detailing interim results from a Phase II open-label trial of vemircopan (ALXN2050) highlighted efficacy and safety data from the treatment-naïve patient group, establishing proof-of-concept as a monotherapy for PNH.
Vemircopan monotherapy controlled IVH as demonstrated by reduction in LDH to |
Condensed Consolidated Financial Statements
Table 18: Condensed consolidated statement of comprehensive income: FY 2022
For the year ended 31 December |
| 2022 | 2021 |
|
| $m | $m |
Total Revenue |
| 44,351 | 37,417 |
Product Sales |
| 42,998 | 36,541 |
Collaboration Revenue |
| 1,353 | 876 |
Cost of sales | (12,391) | (12,437) | |
Gross profit |
| 31,960 | 24,980 |
Distribution expense | (536) | (446) | |
Research and development expense | (9,762) | (9,736) | |
Selling, general and administrative expense | (18,419) | (15,234) | |
Other operating income and expense | 514 | 1,492 | |
Operating profit |
| 3,757 | 1,056 |
Finance income | 95 | 43 | |
Finance expense | (1,346) | (1,300) | |
Share of after tax losses in associates and joint ventures | (5) | (64) | |
Profit/(loss) before tax |
| 2,501 | (265) |
Taxation | 792 | 380 | |
Profit for the period |
| 3,293 | 115 |
Other comprehensive income |
|
|
|
Items that will not be reclassified to profit or loss |
|
|
|
Remeasurement of the defined benefit pension liability | 1,118 | 626 | |
Net losses on equity investments measured at fair value through other comprehensive income | (88) | (187) | |
Fair value movements related to own credit risk on bonds designated as fair value through profit or loss | 2 | - | |
Tax on items that will not be reclassified to profit or loss | (216) | 105 | |
|
| 816 | 544 |
Items that may be reclassified subsequently to profit or loss | |||
Foreign exchange arising on consolidation | (1,446) | (483) | |
Foreign exchange arising on designated liabilities in net investment hedges | (282) | (321) | |
Fair value movements on cash flow hedges | (97) | (167) | |
Fair value movements on cash flow hedges transferred to profit and loss | 73 | 208 | |
Fair value movements on derivatives designated in net investment hedges | (8) | 34 | |
Costs of hedging | (7) | (6) | |
Tax on items that may be reclassified subsequently to profit or loss | 73 | 46 | |
(1,694) | (689) | ||
Other comprehensive loss, net of tax |
| (878) | (145) |
Total comprehensive income/(loss) for the period |
| 2,415 | (30) |
Profit attributable to: | |||
Owners of the Parent | 3,288 | 112 | |
Non-controlling interests | 5 | 3 | |
3,293 | 115 | ||
Total comprehensive income/(loss) attributable to: | |||
Owners of the Parent | 2,413 | (33) | |
Non-controlling interests | 2 | 3 | |
2,415 | (30) | ||
Basic earnings per $0.25 Ordinary Share | $2.12 | $0.08 | |
Diluted earnings per $0.25 Ordinary Share | $2.11 | $0.08 | |
Weighted average number of Ordinary Shares in issue (millions) | 1,548 | 1,418 | |
Diluted weighted average number of Ordinary Shares in issue (millions) | 1,560 | 1,427 |
Table 19: Condensed consolidated statement of comprehensive income: Q4 2022
For the quarter ended 31 December |
| 2022 | 2021 |
|
| $m | $m |
Total Revenue |
| 11,207 | 12,011 |
Product Sales |
| 10,798 | 11,498 |
Collaboration Revenue |
| 409 | 513 |
Cost of sales | (2,900) | (4,625) | |
Gross profit |
| 8,307 | 7,386 |
Distribution expense | (156) | (124) | |
Research and development expense | (2,625) | (2,584) | |
Selling, general and administrative expense | (4,621) | (5,117) | |
Other operating income and expense | 189 | 147 | |
Operating profit/(loss) |
| 1,094 | (292) |
Finance income | 45 | 1 | |
Finance expense | (360) | (336) | |
Share of after tax losses in associates and joint ventures | (1) | (9) | |
Profit/(loss) before tax |
| 778 | (636) |
Taxation | 124 | 290 | |
Profit/(loss) for the period |
| 902 | (346) |
Other comprehensive income |
|
|
|
Items that will not be reclassified to profit or loss |
|
|
|
Remeasurement of the defined benefit pension liability | (165) | 34 | |
Net losses on equity investments measured at fair value through other comprehensive income | (67) | (331) | |
Fair value movements related to own credit risk on bonds designated as fair value through profit or loss | 1 | (4) | |
Tax on items that will not be reclassified to profit or loss | 75 | 34 | |
|
| (156) | (267) |
Items that may be reclassified subsequently to profit or loss | |||
Foreign exchange arising on consolidation | 1,047 | (115) | |
Foreign exchange arising on designated liabilities in net investment hedges | 39 | (46) | |
Fair value movements on cash flow hedges | 117 | (64) | |
Fair value movements on cash flow hedges transferred to profit and loss | (177) | 71 | |
Fair value movements on derivatives designated in net investment hedges | (41) | 12 | |
Costs of hedging | 4 | - | |
Tax on items that may be reclassified subsequently to profit or loss | (22) | 9 | |
967 | (133) | ||
Other comprehensive income/(loss), net of tax |
| 811 | (400) |
Total comprehensive income/(loss) for the period |
| 1,713 | (746) |
Profit/(loss) attributable to: | |||
Owners of the Parent | 901 | (347) | |
Non-controlling interests | 1 | 1 | |
902 | (346) | ||
Total comprehensive income/(loss) attributable to: | |||
Owners of the Parent | 1,712 | (747) | |
Non-controlling interests | 1 | 1 | |
1,713 | (746) | ||
Basic earnings per $0.25 Ordinary Share | $0.58 | $(0.22) | |
Diluted earnings per $0.25 Ordinary Share | $0.58 | $(0.22) | |
Weighted average number of Ordinary Shares in issue (millions) | 1,549 | 1,547 | |
Diluted weighted average number of Ordinary Shares in issue (millions) | 1,559 | 1,547 |
Table 20: Condensed consolidated statement of financial position
| At 31 Dec 2022 | At 31 Dec 2021 | |
| $m | $m | |
Assets | |||
Non-current assets | |||
Property, plant and equipment | 8,507 | 9,183 | |
Right-of-use assets | 942 | 988 | |
Goodwill | 19,820 | 19,997 | |
Intangible assets | 39,307 | 42,387 | |
Investments in associates and joint ventures | 76 | 69 | |
Other investments | 1,066 | 1,168 | |
Derivative financial instruments | 74 | 102 | |
Other receivables | 835 | 895 | |
Deferred tax assets | 3,263 | 4,330 | |
| 73,890 | 79,119 | |
Current assets | |||
Inventories | 4,699 | 8,983 | |
Trade and other receivables | 10,521 | 9,644 | |
Other investments | 239 | 69 | |
Derivative financial instruments | 87 | 83 | |
Intangible assets | - | 105 | |
Income tax receivable | 731 | 663 | |
Cash and cash equivalents | 6,166 | 6,329 | |
Assets held for sale | 150 | 368 | |
| 22,593 | 26,244 | |
Total assets |
| 96,483 | 105,363 |
Liabilities | |||
Current liabilities | |||
Interest-bearing loans and borrowings | (5,314) | (1,660) | |
Lease liabilities | (228) | (233) | |
Trade and other payables | (19,040) | (18,938) | |
Derivative financial instruments | (93) | (79) | |
Provisions | (722) | (768) | |
Income tax payable | (896) | (916) | |
| (26,293) | (22,594) | |
Non-current liabilities | |||
Interest-bearing loans and borrowings | (22,965) | (28,134) | |
Lease liabilities | (725) | (754) | |
Derivative financial instruments | (164) | (45) | |
Deferred tax liabilities | (2,944) | (6,206) | |
Retirement benefit obligations | (1,168) | (2,454) | |
Provisions | (896) | (956) | |
Other payables | (4,270) | (4,933) | |
(33,132) | (43,482) | ||
Total liabilities |
| (59,425) | (66,076) |
Net assets |
| 37,058 | 39,287 |
Equity | |||
Capital and reserves attributable to equity holders of the Parent | |||
Share capital | 387 | 387 | |
Share premium account | 35,155 | 35,126 | |
Other reserves | 2,069 | 2,045 | |
Retained earnings | (574) | 1,710 | |
| 37,037 | 39,268 | |
Non-controlling interests | 21 | 19 | |
Total equity |
| 37,058 | 39,287 |
Table 21: Condensed consolidated statement of changes in equity
Share capital | Share premium account | Other reserves | Retained earnings | Total attributable to owners of the parent | Non-controlling interests | Total equity | ||
| $m | $m | $m | $m | $m | $m | $m | |
At 1 Jan 2021 | 328 | 7,971 | 2,024 | 5,299 | 15,622 | 16 | 15,638 | |
Profit for the period | - | - | - | 112 | 112 | 3 | 115 | |
Other comprehensive loss | - | - | - | (145) | (145) | - | (145) | |
Transfer to other reserves | - | - | 21 | (21) | - | - | - | |
Transactions with owners | ||||||||
Dividends | - | - | - | (3,882) | (3,882) | - | (3,882) | |
Issue of Ordinary Shares | 59 | 27,155 | - | - | 27,214 | - | 27,214 | |
Share-based payments charge for the period | - | - | - | 615 | 615 | - | 615 | |
Settlement of share plan awards | - | - | - | (781) | (781) | - | (781) | |
Issue of replacement Alexion share awards upon acquisition | - | - | - | 513 | 513 | - | 513 | |
Net movement |
| 59 | 27,155 | 21 | (3,589) | 23,646 | 3 | 23,649 |
At 31 Dec 2021 |
| 387 | 35,126 | 2,045 | 1,710 | 39,268 | 19 | 39,287 |
|
|
|
|
|
|
|
|
|
At 1 Jan 2022 |
| 387 | 35,126 | 2,045 | 1,710 | 39,268 | 19 | 39,287 |
Profit for the period | - | - | - | 3,288 | 3,288 | 5 | 3,293 | |
Other comprehensive loss | - | - | - | (875) | (875) | (3) | (878) | |
Transfer to other reserves | - | - | 24 | (24) | - | - | - | |
Transactions with owners | ||||||||
Dividends | - | - | - | (4,485) | (4,485) | - | (4,485) | |
Issue of Ordinary Shares | - | 29 | - | - | 29 | - | 29 | |
Share-based payments charge for the period | - | - | - | 619 | 619 | - | 619 | |
Settlement of share plan awards | - | - | - | (807) | (807) | - | (807) | |
Net movement | - | 29 | 24 | (2,284) | (2,231) | 2 | (2,229) | |
At 31 Dec 2022 |
| 387 | 35,155 | 2,069 | (574) | 37,037 | 21 | 37,058 |
Table 22: Condensed consolidated statement of cash flows
For the year ended 31 December | 2022 | 2021 | |
$m | $m |
Cash flows from operating activities | |||
Profit/(loss) before tax | 2,501 | (265) | |
Finance income and expense | 1,251 | 1,257 | |
Share of after tax losses of associates and joint ventures | 5 | 64 | |
Depreciation, amortisation and impairment | 5,480 | 6,530 | |
Increase in trade and other receivables | (1,349) | (961) | |
Decrease in inventories | 3,941 | 1,577 | |
Increase in trade and other payables and provisions | 1,165 | 1,405 | |
Gains on disposal of intangible assets | (104) | (513) | |
Gains on disposal of investments in associates and joint ventures | - | (776) | |
Fair value movements on contingent consideration arising from business combinations | 82 | 14 | |
Non-cash and other movements | (692) | 95 | |
Cash generated from operations |
| 12,280 | 8,427 |
Interest paid | (849) | (721) | |
Tax paid | (1,623) | (1,743) | |
Net cash inflow from operating activities |
| 9,808 | 5,963 |
Cash flows from investing activities |
| ||
Acquisition of subsidiaries, net of cash acquired | (48) | (9,263) | |
Payments upon vesting of employee share awards attributable to business combinations | (215) | (211) | |
Payment of contingent consideration from business combinations | (772) | (643) | |
Purchase of property, plant and equipment | (1,091) | (1,091) | |
Disposal of property, plant and equipment | 282 | 13 | |
Purchase of intangible assets | (1,480) | (1,109) | |
Disposal of intangible assets and assets held for sale | 447 | 587 | |
Movement in profit-participation liability | - | 20 | |
Purchase of non-current asset investments | (45) | (184) | |
Disposal of non-current asset investments | 42 | 9 | |
Movement in short-term investments, fixed deposits and other investing instruments | (114) | 96 | |
Payments to associates and joint ventures | (26) | (92) | |
Disposal of investments in associates and joint ventures | - | 776 | |
Interest received | 60 | 34 | |
Net cash outflow from investing activities | (2,960) | (11,058) | |
Net cash inflow/(outflow) before financing activities |
| 6,848 | (5,095) |
Cash flows from financing activities | |||
Proceeds from issue of share capital | 29 | 29 | |
Issue of loans and borrowings | - | 12,929 | |
Repayment of loans and borrowings | (1,271) | (4,759) | |
Dividends paid | (4,364) | (3,856) | |
Hedge contracts relating to dividend payments | (127) | (29) | |
Repayment of obligations under leases | (244) | (240) | |
Movement in short-term borrowings | 74 | (276) | |
Payments to acquire non-controlling interests | - | (149) | |
Payment of Acerta Pharma share purchase liability | (920) | - | |
Net cash (outflow)/inflow from financing activities |
| (6,823) | 3,649 |
Net increase/(decrease) in Cash and cash equivalents in the period | 25 | (1,446) | |
Cash and cash equivalents at the beginning of the period | 6,038 | 7,546 | |
Exchange rate effects | (80) | (62) | |
Cash and cash equivalents at the end of the period |
| 5,983 | 6,038 |
Cash and cash equivalents consist of: |
| ||
Cash and cash equivalents | 6,166 | 6,329 | |
Overdrafts | (183) | (291) | |
|
| 5,983 | 6,038 |
Notes to the Condensed Consolidated Financial Statements
Note 1: Basis of preparation and accounting policies
The Condensed Consolidated Financial Statements for the year ended 31 December 2022 have been prepared in accordance with UK-adopted International Accounting Standards and with the requirements of the Companies Act 2006 as applicable to companies reporting under those standards. The Condensed Consolidated Financial Statements also comply fully with International Financial Reporting Standards (IFRSs) as issued by the International Accounting Standards Board (IASB) and International Accounting Standards as adopted by the European Union.
The Condensed Consolidated Financial Statements for the year ended 31 December 2022 include Alexion's results for the period. Alexion's post-acquisition results for 2021 were consolidated into the Group's results from 21 July 2021 therefore the respective comparative periods shown are not entirely comparable with the current period.
These Condensed Consolidated Financial Statements comprise the financial results of AstraZeneca PLC for the years to 31 December 2022 and 2021 together with the Statement of financial position as at 31 December 2022 and 2021. The results for the year to 31 December 2022 have been extracted from the 31 December 2022 audited Consolidated Financial Statements which have been approved by the Board of Directors. These have not yet been delivered to the Registrar of Companies but are expected to be published on 21 February 2023 within the Annual Report and Form 20-F Information 2022.
The financial information set out above does not constitute the Group's statutory accounts for the years to 31 December 2022 or 2021 but is derived from those accounts. The auditors have reported on those accounts: their reports (i) were unqualified, (ii) did not include a reference to any matters to which the auditors drew attention by way of emphasis without qualifying their report and (iii) did not contain a statement under section 498 (2) or (3) of the Companies Act 2006 in respect of the accounts for the year to 31 December 2022 or 31 December 2021. Statutory accounts for the year to 31 December 2022 were approved by the Board of Directors for release on 9 February 2023.
The Condensed Consolidated Financial Statements have been prepared applying the accounting policies that were applied in the preparation of the Group's published consolidated financial statements for the year ended 31 December 2021.
AstraZeneca has assessed the impact of the uncertainty presented by the COVID-19 pandemic and the Russia-Ukraine conflict on the Financial Statements, specifically considering the impact on key judgements and significant estimates along with several other areas of increased risk. No material accounting impacts relating to COVID-19 or the Russia-Ukraine conflict were recognised in the year.
Going concern
The Group has considerable financial resources available. As at 31 December 2022, the Group has $11.1bn in financial resources (Cash and cash equivalent balances of $6.2bn and undrawn committed bank facilities of $4.9bn available until April 2026 with only $5.5bn of borrowings due within one year). All facilities contain no financial covenants and were undrawn at 31 December 2022. On 2 February 2023, the Group entered into an additional $2.0bn of two-year committed bank facilities.
The Group's revenues are largely derived from sales of medicines covered by patents. which provide a relatively high level of resilience and predictability to cash inflows, although government price interventions in response to budgetary constraints are expected to continue to adversely affect revenues in some of our significant markets. The Group, however, anticipates new revenue streams from both recently launched medicines and those in development, and the Group has a wide diversity of customers and suppliers across different geographic areas.
Consequently, the Directors believe that, overall, the Group is well placed to manage its business risks successfully. Accordingly, they continue to adopt the going concern basis in preparing the Condensed Consolidated Financial Statements.
Legal proceedings
The information contained in Note 6 updates the disclosures concerning legal proceedings and contingent liabilities in the Group's Annual Report and Form 20-F Information 2021.
Note 2: Intangible assets
In accordance with IAS 36 'Impairment of Assets', reviews for triggers of impairment or impairment reversals at an individual asset or cash generating unit level were conducted, and impairment tests carried out where triggers were identified. As a result, total net impairment charges of $224m have been recorded against intangible assets during the year ended 31 December 2022 (FY 2021: $2,085m net charge). Net impairment charges in respect of medicines in development and launched medicines were $95m (FY 2021: $1,464m) and $146m (FY 2021: $603m charge) respectively.
Note 3: Net Debt
The table below provides an analysis of Net Debt and a reconciliation of Net Cash Flow to the movement in Net Debt. The Group monitors Net Debt as part of its capital-management policy as described in Note 28 of the Annual Report and Form 20-F Information 2021. Net Debt is a non-GAAP financial measure.
Table 23: Net Debt
| At 1 Jan 2022 | Cash flow | Acquisitions | Non-cash& other | Exchange movements | At 31 Dec 2022 | |
| $m | $m | $m | $m | $m | $m | |
Non-current instalments of loans | (28,134) | - | (2) | 4,957 | 214 | (22,965) | |
Non-current instalments of leases | (754) | - | (3) | (2) | 34 | (725) | |
Total long-term debt |
| (28,888) | - | (5) | 4,955 | 248 | (23,690) |
Current instalments of loans | (1,273) | 1,271 | (3) | (4,959) | - | (4,964) | |
Current instalments of leases | (233) | 253 | (1) | (260) | 13 | (228) | |
Bank collateral received | (93) | 4 | - | - | - | (89) | |
Other short-term borrowings excluding overdrafts | (3) | (78) | - | - | 3 | (78) | |
Overdrafts | (291) | 85 | - | - | 23 | (183) | |
Total current debt |
| (1,893) | 1,535 | (4) | (5,219) | 39 | (5,542) |
Gross borrowings |
| (30,781) | 1,535 | (9) | (264) | 287 | (29,232) |
Net derivative financial instruments | 61 | 73 | - | (230) | - | (96) | |
Net borrowings |
| (30,720) | 1,608 | (9) | (494) | 287 | (29,328) |
Cash and cash equivalents | 6,329 | (72) | 12 | - | (103) | 6,166 | |
Other investments - current | 69 | 168 | 8 | - | (6) | 239 | |
Cash and investments |
| 6,398 | 96 | 20 | - | (109) | 6,405 |
Net Debt |
| (24,322) | 1,704 | 11 | (494) | 178 | (22,923) |
Non-cash movements in the period include fair value adjustments under IFRS 9 Financial Instruments.
The Group has agreements with some bank counterparties whereby the parties agree to post cash collateral on financial derivatives, for the benefit of the other, equivalent to the market valuation of the derivative positions above a predetermined threshold. The carrying value of such cash collateral held by the Group at 31 December 2022 was $89m (31 December 2021: $93m) and the carrying value of such cash collateral posted by the Group at 31 December 2022 was $162m (31 December 2021: $47m). Cash collateral pledged to counterparties is recognised as a financial asset and is included in Other investments - current as at 31 December 2022. In prior years, cash collateral pledged to counterparties was included in Cash and cash equivalents.
The equivalent GAAP measure to Net Debt is 'liabilities arising from financing activities', which excludes the amounts for cash and overdrafts, other investments and non-financing derivatives shown above and includes the Acerta Pharma share purchase liability of $1,646m (31 December 2021: $2,458m), $867m of which is shown in current other payables and $779m is shown in non-current other payables.
Net Debt decreased by $1,399m in the year to $22,923m. Details of the committed undrawn bank facilities are disclosed within the going concern section of Note 1.
During the year ended 31 December 2022, Standard and Poor's upgraded the Company's solicited credit ratings to long term: A; and short term: A-1. There were no changes to Moody's solicited credit ratings (long term: A3; short term: P-2).
Note 4: Financial Instruments
As detailed in the Group's most recent annual financial statements, the principal financial instruments consist of derivative financial instruments, other investments, trade and other receivables, cash and cash equivalents, trade and other payables, lease liabilities and interest-bearing loans and borrowings.
The Group has certain equity investments that are categorised as Level 3 in the fair value hierarchy that are held at $186m at 31 December 2022 (31 December 2021: $104m) and for which fair value gains of $50m (FY 2021: $nil) have been recognised in the year ended 31 December 2022. In the absence of specific market data, these unlisted investments are held at fair value based on the cost of investment and adjusting as necessary for impairments and revaluations on new funding rounds, which are seen to approximate the fair value. All other fair value gains and/or losses that are presented in Net losses on equity investments measured at fair value through other comprehensive income in the Condensed consolidated statement of comprehensive income for the year ended 31 December 2022 are Level 1 fair value measurements, valued based on quoted prices in active markets.
Financial instruments measured at fair value include $1,079m of other investments, $4,486m held in money-market funds, $294m of loans designated at fair value through profit or loss and ($96m) of derivatives as at 31 December 2022. With the exception of derivatives being Level 2 fair valued, certain equity investments as described above and an equity warrant of $19m categorised as Level 3, the aforementioned balances are Level 1 fair valued. Financial instruments measured at amortised cost include $64m of fixed deposits and $162m of cash collateral pledged to counterparties. The total fair value of interest-bearing loans and borrowings at 31 December 2022, which have a carrying value of $29,232m in the Condensed consolidated statement of financial position, was $27,898m.
Table 24: Financial instruments - contingent consideration
| 2022 | 2021 |
|
| Diabetes alliance | Other | Total | Total |
|
| $m | $m | $m | $m |
At 1 January | 2,544 | 321 | 2,865 | 3,323 | |
Settlements | (763) | (9) | (772) | (643) | |
Disposals | - | (121) | (121) | - | |
Revaluations | 182 | (100) | 82 | 14 | |
Reclass to other payables | - | - | - | (55) | |
Discount unwind | 161 | 7 | 168 | 226 | |
At 31 December |
| 2,124 | 98 | 2,222 | 2,865 |
Contingent consideration arising from business combinations is fair valued using decision-tree analysis, with key inputs including the probability of success, consideration of potential delays and the expected levels of future revenues.
The contingent consideration balance relating to BMS's share of the global diabetes alliance of $2,124m (31 December 2021: $2,544m) would increase/decrease by $212m with an increase/decrease in sales of 10%, as compared with the current estimates.
Note 5: Pensions and other post-retirement benefit obligations
The net pensions and other post-retirement benefit obligations position, as recorded under IAS 19 Employee Benefits, at 31 December 2022 was a liability of $1,078m (31 December 2021: $2,454m liability). Pension schemes in a net surplus position at 31 December 2022 totalled $90m and are recorded within Other receivables in non-current assets. Pension schemes in a net deficit position at 31 December 2022 totalled $1,168m (31 December 2021: $2,454m) and are recorded within Retirement benefit obligations in non-current liabilities.
The decrease in the net liability of $1,376m is driven by actuarial gains of $1,118m that have been reflected within the Condensed consolidated statement of comprehensive income.
Changes in actuarial assumptions, primarily movements in discount rates, led to an actuarial gain on scheme obligations in the year of $3,585m (gains in UK, Sweden, US and RoW liabilities of $2,243m, $806m, $268m and $268m respectively), which reflected increases in corporate bond yields. These movements were partially offset by actuarial losses on the pension fund asset values in the year of $2,467m (losses in UK, Sweden, US and ROW assets of $1,964m, $153m, $295m and $55m respectively).
Note 6: Legal proceedings and contingent liabilities
AstraZeneca is involved in various legal proceedings considered typical to its business, including litigation and investigations, including Government investigations, relating to product liability, commercial disputes, infringement of intellectual property (IP) rights, the validity of certain patents, anti-trust law and sales and marketing practices. The matters discussed below constitute the more significant developments since publication of the disclosures concerning legal proceedings in the Company's Annual Report and Form 20-F Information 2021, H1 2022 and Q3 2022 results (the Disclosures). Unless noted otherwise below or in the Disclosures, no provisions have been established in respect of the claims discussed below.
As discussed in the Disclosures, the majority of claims involve highly complex issues. Often these issues are subject to substantial uncertainties and, therefore, the probability of a loss, if any, being sustained and/or an estimate of the amount of any loss is difficult to ascertain.
Unless specifically identified below that a provision has been taken, AstraZeneca considers each of the claims to represent a contingent liability and discloses information with respect to the nature and facts of the cases in accordance with IAS 37.
There is one matter concerning legal proceedings in the Disclosures, which is considered probable that an outflow will be required, but for which we are unable to make an estimate of the possible loss or range of possible losses at this stage.
In cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed and which are not subject to appeal, or where a loss is probable and we are able to make a reasonable estimate of the loss, AstraZeneca records the loss absorbed or makes a provision for its best estimate of the expected loss. The position could change over time and the estimates that the Company made, and upon which the Company have relied in calculating these provisions are inherently imprecise. There can, therefore, be no assurance that any losses that result from the outcome of any legal proceedings will not exceed the amount of the provisions that have been booked in the accounts. The major factors causing this uncertainty are described more fully in the Disclosures and herein.
AstraZeneca has full confidence in, and will vigorously defend and enforce, its IP.
Matters disclosed in respect of the fourth quarter of 2022 and to 9 February 2023
Patent litigation
Calquence
US patent proceedings
As previously disclosed, in February 2022, in response to Paragraph IV notices from multiple ANDA filers, AstraZeneca filed patent infringement lawsuits in the US District Court for the District of Delaware. In its complaint, AstraZeneca alleges that a generic version of Calquence, if approved and marketed, would infringe patents listed in the US FDA Orange Book with reference to Calquence that are owned or licensed by AstraZeneca. Trial has been scheduled for March 2025.
In February 2023, Sandoz Inc. filed a petition for inter partes review with the US Patent and Trademark Office (USPTO) of certain Calquence patent claims in US Patent No. 10,272,083 (the '083 patent)). AstraZeneca has asserted claims for infringement of the '083 patent against Sandoz and other defendants in the US ANDA litigation. AstraZeneca is considering its response to Sandoz's petition before the USPTO.
Farxiga
US patent proceedings
As previously disclosed, in 2018, in response to Paragraph IV notices, AstraZeneca initiated abbreviated new drug application (ANDA) litigation against Zydus Pharmaceuticals (USA) Inc. (Zydus) in the US District Court for the District of Delaware (the District Court). In May 2021, trial against Zydus proceeded and in October 2021, the District Court issued a decision finding the asserted claims of AstraZeneca's patent as valid and infringed by Zydus's ANDA product. In August 2022, Zydus appealed the District Court's decision. In November 2022, Zydus's appeal was dismissed. Additional ANDA challenges are pending.
Imjudo
US patent proceedings
In January 2023, Bristol-Myers Squibb Co. and E.R. Squibb & Sons, LLC filed a lawsuit in US District Court for the District of Delaware against AstraZeneca alleging that AstraZeneca's marketing of Imjudo infringes two of their patents.
Lokelma
US patent proceedings
As previously disclosed, in August 2022, in response to Paragraph IV notices, AstraZeneca initiated ANDA litigation against multiple generic filers in the US District Court for the District of Delaware. A trial has been scheduled for March 2025.
Symbicort
US patent proceedings
As previously disclosed, AstraZeneca is involved in two ongoing ANDA patent litigations with Mylan Pharmaceuticals Inc. (Mylan) and Kindeva Drug Delivery L.P. (Kindeva) brought in the US District Court for the Northern District of West Virginia (the District Court). In one of those matters, in November 2022, the District Court determined that the asserted patent was invalid. AstraZeneca appealed that decision to the United States Court of Appeals for the Federal Circuit (the Federal Circuit). With respect to the other matter, following a stipulation of infringement and validity by Mylan and Kindeva that was subject to certain appeal issues, in December 2022, the District Court issued a Final Judgment in favour of AstraZeneca. In December 2022, Mylan and Kindeva appealed the Final Judgment to the Federal Circuit. Both appeals are scheduled to be heard in March 2023.
Tagrisso
Patent proceedings outside the US
As previously disclosed, in Russia in October 2021, AstraZeneca filed a lawsuit in the Arbitration Court of the Moscow Region (the Court) against Axelpharm, LLC to prevent it from obtaining authorisation to market a generic version of Tagrisso prior to the expiration of AstraZeneca's patents covering Tagrisso. The lawsuit also names the Ministry of Health of the Russian Federation as a third party. In March 2022, the Court dismissed the lawsuit. In June 2022, the dismissal was affirmed on appeal. In January 2023, the dismissal was affirmed on further appeal. AstraZeneca is considering its option.
Lynparza
US patent proceedings
In December 2022, AstraZeneca received a Paragraph IV notice letter from an ANDA filer relating to patents listed in the FDA Orange Book with reference to Lynparza. AstraZeneca is reviewing the notice letter.
Product liability litigation
Byetta/Bydureon
US proceedings
As previously disclosed, Amylin Pharmaceuticals, LLC (a wholly owned subsidiary of AstraZeneca) and AstraZeneca are among multiple defendants in various lawsuits filed in federal and state courts involving claims of physical injury from treatment with Byetta and/or Bydureon. The lawsuits allege several types of injuries including pancreatic cancer and thyroid cancer. A multidistrict litigation was established in the US District Court for the Southern District of California (the District Court) in regard to the alleged pancreatic cancer cases in federal courts. Further, a coordinated proceeding has been established in Superior Court in Los Angeles, California (the California Court) for cases in California state courts. In March and April 2021, the District Court and the California Court respectively granted Defendants' summary judgment motions, dismissing all cases alleging pancreatic cancer with prejudice. All remaining claims in both courts, including those alleging thyroid cancer, have since been dismissed. This matter is now concluded.
Nexium and Losec/Prilosec
US proceedings
As previously disclosed, AstraZeneca is defending various lawsuits brought in US federal and state courts involving multiple plaintiffs claiming that they have been diagnosed with various injuries following treatment with proton pump inhibitors (PPIs), including Nexium and Prilosec. The vast majority of these lawsuits relate to allegations of kidney injuries. In August 2017, the pending federal court cases were consolidated in a multidistrict litigation (MDL) proceeding in the US District Court for the District of New Jersey for pre-trial purposes. A bellwether trial has been scheduled for June 2023, with subsequent bellwether trials scheduled for July and September 2023. In addition to the MDL cases, there are cases filed in several state courts around the US; a case that was previously set to go to trial in Delaware state court was dismissed in October 2022.
Commercial Litigation
Anti-Terrorism Act Civil Lawsuit
As previously disclosed, in October 2017, AstraZeneca and certain other pharmaceutical and/or medical device companies were named as defendants in a complaint filed in US District Court for the District of Columbia (the District Court) by US nationals (or their estates, survivors, or heirs) who were killed or wounded in Iraq between 2005 and 2013. The plaintiffs allege that the defendants violated the US Anti-Terrorism Act and various state laws by selling pharmaceuticals and medical supplies to the Iraqi Ministry of Health. In July 2020, the District Court granted AstraZeneca's and the other defendants' motion and dismissed the lawsuit, and the plaintiffs appealed to the DC Circuit Court of Appeals (the Appellate Court). In January 2022, a panel of the Appellate Court reversed the dismissal and remanded the case back to the District Court. AstraZeneca and the other defendants filed petitions requesting en banc review by the entire Appellate Court, which were denied in February 2023.
Employment Litigation (US)
In December 2022, AstraZeneca was served with a lawsuit filed by seven former employees in the US District Court for the District of Delaware asserting age, religion, and disability discrimination claims related to AstraZeneca's COVID-19 vaccine mandate. These claims are pled on a single-plaintiff and class action basis.
Pay Equity Litigation (US)
AstraZeneca is defending a putative class and collective action matter in the US District Court for the Northern District of Illinois brought by three named plaintiffs, who are former AstraZeneca pharmaceutical sales representatives. The case involves claims under the federal and Illinois Equal Pay Acts, with the plaintiffs alleging they were paid less than male employees who performed substantially similar and/or equal work. The plaintiffs seek various damages on behalf of themselves and the putative class and/or collective, including without limitation backpay, liquidated damages, compensatory and punitive damages, attorneys' fees, and interest. In January 2023, the District Court granted AstraZeneca's motion to dismiss plaintiffs' complaint.
Government investigations/proceedings
Brazilian Operations Investigation (Brazil)
In May 2017, Brazilian authorities seized records and data from Alexion's Brazil offices as part of an investigation being conducted into Alexion's Brazilian operations. AstraZeneca cooperated with this enquiry. The prosecutor recommended discontinuance in September 2022 after determining that there was insufficient evidence to support a legal claim. The judicial authority approved discontinuance of the investigation, without any further enforcement action, in November 2022. This matter is now concluded.
Texas Qui Tam
US proceedings
In December 2022, AstraZeneca was served with an unsealed civil lawsuit brought by a qui tam relator on behalf of the State of Texas in Texas state court, which alleges that AstraZeneca engaged in unlawful marketing practices.
US 340B Litigations and Proceedings
US proceedings
As previously disclosed, in January 2021, AstraZeneca filed a lawsuit in US District Court for the District of Delaware (the District Court) alleging that an Advisory Opinion issued by the Department of Health and Human Services violates the Administrative Procedure Act. AstraZeneca later amended its complaint to include allegations challenging letters the US government issued in May 2021 asserting that AstraZeneca's contract pharmacy policy violates the 340B statute. In February 2022, the District Court ruled in favour of AstraZeneca. In January 2023, the Court of Appeals affirmed the District Court decision.
Note 7: Subsequent events
On 9 January 2023, it was announced that AstraZeneca had entered into a definitive agreement to acquire CinCor Pharma, Inc., a US-based clinical-stage biopharmaceutical company, focused on developing novel treatments for resistant and uncontrolled hypertension as well as chronic kidney disease. On 23 January 2023, AstraZeneca initiated a tender offer to acquire all of CinCor's outstanding shares for a price of $26 per share in cash at closing, plus a non-tradable contingent value right of $10 per share in cash payable upon a specified regulatory submission of a baxdrostat product. Combined, the upfront and maximum potential contingent value payments represent, if achieved, a transaction value of approximately $1.8bn. As part of the transaction, AstraZeneca will acquire the cash and marketable securities on CinCor's balance sheet, which totalled approximately $522m as of 30 September 2022. The transaction is expected to close in the first quarter of 2023.
On 16 January 2023, AstraZeneca completed the acquisition of Neogene Therapeutics Inc. AstraZeneca acquired all outstanding equity of Neogene for a total consideration of up to $320m, on a cash and debt free basis. This includes an initial payment of $200m on deal closing, and a further up to $120m in both contingent milestones-based and non-contingent consideration.
On 30 January 2023, AstraZeneca completed the sale of its West Chester site in Ohio, US, to National Resilience, Inc. On completion of the sale, the Property, plant and equipment assets associated with this transaction of $150m which were recorded as Assets held for sale as at 31 December 2022 have been disposed of, with no net impact recorded in the Consolidated statement of comprehensive income.
On 2 February 2023, the Group entered into an additional $2.0bn of two-year committed bank facilities.
Table 25: FY 2022 - Product Sales year-on-year analysis[77]
The CER information in respect of FY 2022 included in the Consolidated Financial Information has not been audited by PricewaterhouseCoopers LLP.
| World | Emerging Markets | US | Europe | Established RoW | |||||||||
| $m | Act % chg | CER % chg | $m | Act % chg | CER % chg | $m | % chg | $m | Act % chg | CER % chg | $m | Act % chg | CER % chg |
Oncology | 14,631 | 13 | 19 | 3,537 | 10 | 14 | 6,484 | 23 | 2,726 | 10 | 23 | 1,884 | (5) | 10 |
Tagrisso | 5,444 | 9 | 15 | 1,567 | 17 | 22 | 2,007 | 13 | 1,023 | 4 | 17 | 847 | (7) | 8 |
Imfinzi | 2,784 | 15 | 21 | 287 | 4 | 7 | 1,552 | 25 | 544 | 12 | 26 | 401 | (1) | 15 |
Lynparza | 2,638 | 12 | 18 | 488 | 27 | 31 | 1,226 | 13 | 655 | 6 | 19 | 269 | 4 | 20 |
Calquence | 2,057 | 66 | 69 | 45 | n/m | n/m | 1,657 | 52 | 286 | n/m | n/m | 69 | n/m | n/m |
Enhertu | 79 | n/m | n/m | 51 | n/m | n/m | - | - | 21 | n/m | n/m | 7 | n/m | n/m |
Orpathys | 33 | n/m | n/m | 33 | n/m | n/m | - | - | - | - | - | - | - | - |
Zoladex | 927 | (2) | 6 | 657 | 6 | 12 | 15 | 15 | 133 | (10) | 1 | 122 | (28) | (15) |
Faslodex | 334 | (22) | (14) | 159 | (4) | 3 | 17 | (45) | 55 | (52) | (46) | 103 | (15) | 1 |
Iressa | 114 | (38) | (34) | 94 | (38) | (35) | 9 | (19) | 2 | (52) | (41) | 9 | (44) | (35) |
Arimidex | 99 | (29) | (24) | 76 | (29) | (26) | - | - | - | (87) | (86) | 23 | (23) | (11) |
Casodex | 78 | (45) | (40) | 53 | (50) | (47) | - | - | 1 | (49) | (48) | 24 | (31) | (19) |
Others | 44 | (14) | (6) | 27 | (6) | 1 | 1 | 59 | 6 | (4) | 4 | 10 | (36) | (26) |
BioPharmaceuticals: CVRM* | 9,188 | 13 | 19 | 4,119 | 9 | 15 | 2,479 | 11 | 1,906 | 25 | 40 | 684 | 10 | 25 |
Farxiga | 4,381 | 46 | 56 | 1,665 | 39 | 47 | 1,071 | 46 | 1,297 | 60 | 81 | 348 | 32 | 49 |
Brilinta | 1,358 | (8) | (4) | 286 | (13) | (10) | 744 | 1 | 282 | (18) | (8) | 46 | (27) | (22) |
Lokelma | 289 | 65 | 75 | 20 | n/m | n/m | 170 | 47 | 30 | n/m | n/m | 69 | 55 | 83 |
Roxadustat | 197 | 13 | 18 | 197 | 13 | 18 | - | - | - | - | - | - | - | - |
Andexxa* | 150 | 5 | 14 | - | - | - | 77 | (32) | 41 | 41 | 58 | 32 | n/m | n/m |
Crestor | 1,048 | (4) | 2 | 794 | 2 | 9 | 65 | (19) | 41 | (21) | (12) | 148 | (21) | (10) |
Seloken/Toprol-XL | 862 | (9) | (4) | 839 | (10) | (4) | - | n/m | 14 | 26 | 27 | 9 | (16) | (13) |
Bydureon | 280 | (27) | (26) | 3 | (16) | (18) | 242 | (24) | 35 | (37) | (29) | - | (95) | (94) |
Onglyza | 257 | (28) | (25) | 121 | (32) | (28) | 76 | (13) | 38 | (37) | (29) | 22 | (32) | (30) |
Others | 366 | (10) | (7) | 194 | (1) | 4 | 34 | (35) | 128 | (12) | (10) | 10 | (32) | (24) |
BioPharmaceuticals: R&I | 5,765 | (4) | - | 1,443 | (18) | (14) | 2,655 | 10 | 1,054 | (15) | (5) | 613 | (3) | 7 |
Symbicort | 2,538 | (7) | (2) | 608 | - | 5 | 973 | (9) | 582 | (13) | (3) | 375 | (2) | 5 |
Fasenra | 1,396 | 11 | 15 | 43 | n/m | n/m | 906 | 15 | 305 | 7 | 20 | 142 | (12) | (1) |
Breztri | 398 | 96 | n/m | 92 | 68 | 75 | 239 | n/m | 33 | n/m | n/m | 34 | 32 | 56 |
Saphnelo | 116 | n/m | n/m | - | - | - | 111 | n/m | 2 | n/m | n/m | 3 | n/m | n/m |
Tezspire | 4 | n/m | n/m | - | - | - | - | - | 2 | n/m | n/m | 2 | n/m | n/m |
Pulmicort | 645 | (33) | (31) | 462 | (40) | (39) | 65 | (9) | 69 | (6) | 6 | 49 | 5 | 15 |
Daliresp/Daxas | 189 | (17) | (16) | 3 | (28) | (24) | 176 | (15) | 9 | (39) | (32) | 1 | 3 | 7 |
Bevespi | 58 | 7 | 9 | 5 | 31 | 38 | 42 | 7 | 10 | (7) | 5 | 1 | n/m | n/m |
Others | 421 | (29) | (27) | 230 | (20) | (17) | 143 | 32 | 42 | (77) | (75) | 6 | (53) | (46) |
BioPharmaceuticals: V&I | 4,736 | 2 | 8 | 1,316 | (43) | (41) | 1,168 | n/m | 1,027 | (33) | (24) | 1,225 | 68 | 89 |
Vaxzevria | 1,798 | (54) | (52) | 729 | (67) | (67) | 79 | 24 | 365 | (65) | (61) | 625 | 8 | 17 |
Evusheld | 2,185 | n/m | n/m | 413 | n/m | n/m | 1,067 | n/m | 298 | n/m | n/m | 407 | n/m | n/m |
Synagis | 578 | 41 | 59 | 173 | n/m | n/m | 1 | (94) | 213 | 5 | 17 | 191 | 28 | 51 |
FluMist | 175 | (31) | (20) | 1 | (51) | (54) | 21 | (21) | 151 | (32) | (20) | 2 | (4) | (10) |
Rare Disease* | 7,053 | 4 | 10 | 431 | (10) | 6 | 4,324 | 8 | 1,428 | (3) | 9 | 870 | 8 | 24 |
Soliris* | 3,762 | (11) | (5) | 301 | (29) | (10) | 2,180 | (7) | 805 | (21) | (12) | 476 | 11 | 24 |
Ultomiris* | 1,965 | 34 | 42 | 38 | n/m | n/m | 1,136 | 35 | 481 | 49 | 68 | 310 | 6 | 26 |
Strensiq* | 958 | 16 | 18 | 35 | 41 | 31 | 769 | 19 | 78 | (3) | 9 | 76 | (1) | 16 |
Koselugo | 208 | 93 | 96 | 26 | n/m | n/m | 162 | 55 | 20 | n/m | n/m | - | - | - |
Kanuma* | 160 | 16 | 19 | 31 | 73 | 61 | 77 | 12 | 44 | (3) | 10 | 8 | 21 | 38 |
Other medicines | 1,625 | (5) | 4 | 788 | (14) | (9) | 144 | (16) | 123 | (28) | (24) | 570 | 28 | 50 |
Nexium | 1,285 | (3) | 8 | 568 | (19) | (13) | 120 | (6) | 46 | (26) | (17) | 551 | 28 | 50 |
Others | 340 | (10) | (7) | 220 | 4 | 7 | 24 | (45) | 77 | (29) | (27) | 19 | 37 | 54 |
Total Product Sales | 42,998 | 18 | 24 | 11,634 | (4) | 1 | 17,254 | 44 | 8,264 | 9 | 22 | 5,846 | 22 | 40 |
Table 26: Q4 2022 - Product Sales year-on-year analysis[78]
The Q4 2022 information in respect of the three months ended 31 December 2022 included in the Consolidated Financial Information has not been audited by PricewaterhouseCoopers LLP.
| World | Emerging Markets | US | Europe | Established RoW | |||||||||
| $m | Act % chg | CER % chg | $m | Act % chg | CER % chg | $m | % chg | $m | Act % chg | CER % chg | $m | Act % chg | CER % chg |
Oncology | 3,746 | 9 | 18 | 814 | 4 | 14 | 1,789 | 23 | 689 | 4 | 21 | 454 | (13) | 7 |
Tagrisso | 1,342 | 2 | 12 | 356 | 10 | 22 | 535 | 10 | 245 | (5) | 10 | 206 | (16) | 4 |
Imfinzi | 752 | 19 | 27 | 63 | (4) | 3 | 450 | 37 | 142 | 3 | 20 | 97 | (4) | 18 |
Lynparza | 689 | 10 | 17 | 130 | 27 | 33 | 331 | 13 | 162 | - | 16 | 66 | (7) | 15 |
Calquence | 588 | 49 | 53 | 17 | n/m | n/m | 465 | 39 | 86 | n/m | n/m | 20 | n/m | n/m |
Enhertu | 28 | n/m | n/m | 17 | n/m | n/m | - | - | 8 | n/m | n/m | 3 | n/m | n/m |
Orpathys | (1) | n/m | n/m | (1) | n/m | n/m | - | - | - | - | - | - | - | - |
Zoladex | 210 | (9) | 4 | 149 | (3) | 10 | 4 | 71 | 33 | (6) | 10 | 24 | (42) | (25) |
Faslodex | 74 | (27) | (14) | 38 | (14) | (2) | 1 | (76) | 11 | (46) | (38) | 24 | (23) | (3) |
Iressa | 24 | (32) | (24) | 19 | (34) | (26) | 3 | 55 | - | (44) | 21 | 2 | (52) | (44) |
Arimidex | 14 | (57) | (50) | 10 | (61) | (56) | - | - | - | - | - | 4 | (39) | (27) |
Casodex | 16 | (28) | (16) | 10 | (27) | (16) | - | - | 1 | n/m | n/m | 5 | (38) | (23) |
Others | 10 | (29) | (18) | 6 | (18) | (6) | - | - | 1 | (8) | (10) | 3 | (40) | (31) |
BioPharmaceuticals: CVRM | 2,281 | 12 | 22 | 938 | 8 | 20 | 696 | 15 | 493 | 25 | 44 | 154 | (11) | 6 |
Farxiga | 1,177 | 39 | 52 | 441 | 39 | 52 | 323 | 42 | 342 | 52 | 76 | 71 | (8) | 9 |
Brilinta | 345 | (1) | 4 | 64 | (11) | (6) | 206 | 16 | 67 | (19) | (6) | 8 | (48) | (41) |
Lokelma | 81 | 50 | 63 | 6 | n/m | n/m | 48 | 40 | 9 | 98 | n/m | 18 | 18 | 49 |
Roxadustat | 49 | 65 | 87 | 49 | 66 | 87 | - | - | - | - | - | - | - | - |
Andexxa | 39 | - | 14 | - | - | - | 15 | (51) | 12 | 37 | 63 | 12 | n/m | n/m |
Crestor | 224 | (13) | (2) | 164 | (8) | 4 | 15 | (28) | 11 | 24 | 42 | 34 | (33) | (18) |
Seloken/Toprol-XL | 157 | (23) | (12) | 150 | (24) | (13) | - | - | 4 | n/m | n/m | 3 | (23) | (30) |
Bydureon | 73 | (20) | (20) | - | (51) | (59) | 66 | (16) | 7 | (47) | (38) | - | (49) | (98) |
Onglyza | 52 | (31) | (24) | 22 | (20) | (8) | 16 | (38) | 9 | (37) | (26) | 5 | (36) | (32) |
Others | 84 | (13) | (6) | 42 | (6) | 6 | 7 | (42) | 32 | (11) | (8) | 3 | (13) | (3) |
BioPharmaceuticals: R&I | 1,447 | (9) | (3) | 341 | (23) | (16) | 692 | 7 | 259 | (23) | (10) | 155 | (5) | 10 |
Symbicort | 620 | (9) | (2) | 133 | (13) | (3) | 255 | (2) | 137 | (20) | (7) | 95 | (2) | 11 |
Fasenra | 381 | 7 | 12 | 13 | n/m | n/m | 257 | 10 | 76 | 2 | 18 | 35 | (18) | (2) |
Breztri | 116 | 59 | 68 | 21 | 44 | 66 | 75 | 59 | 11 | n/m | n/m | 9 | 8 | 34 |
Saphnelo | 48 | n/m | n/m | - | - | - | 46 | n/m | 1 | n/m | n/m | 1 | n/m | n/m |
Tezspire | 4 | n/m | n/m | - | - | - | - | - | 2 | n/m | n/m | 2 | n/m | n/m |
Pulmicort | 166 | (33) | (28) | 123 | (36) | (32) | 12 | (37) | 19 | (19) | (7) | 12 | (5) | 11 |
Daliresp/Daxas | 28 | (52) | (52) | 1 | (53) | (49) | 25 | (54) | 2 | (39) | (30) | - | - | - |
Bevespi | 14 | (5) | (1) | 1 | 28 | 46 | 10 | (1) | 3 | (27) | (15) | - | - | - |
Others | 70 | (53) | (47) | 49 | (36) | (27) | 12 | (20) | 8 | (86) | (83) | 1 | (57) | (43) |
BioPharmaceuticals: V&I | 1,129 | (51) | (44) | 321 | (74) | (72) | 226 | n/m | 334 | (49) | (40) | 248 | (25) | (7) |
Vaxzevria | 85 | (95) | (94) | 45 | (96) | (95) | - | - | 40 | (87) | (84) | - | - | - |
Evusheld | 734 | n/m | n/m | 246 | n/m | n/m | 217 | n/m | 99 | 50 | 74 | 172 | n/m | n/m |
Synagis | 194 | (19) | (3) | 29 | 46 | 77 | (1) | n/m | 90 | (26) | (14) | 76 | (21) | (3) |
FluMist | 116 | (35) | (24) | 1 | (39) | (43) | 10 | n/m | 105 | (39) | (27) | - | (88) | (86) |
Rare Disease | 1,816 | 4 | 10 | 116 | (12) | 2 | 1,149 | 10 | 349 | (6) | 7 | 202 | (1) | 19 |
Soliris | 844 | (22) | (16) | 83 | (29) | (12) | 491 | (19) | 179 | (26) | (15) | 91 | (18) | (4) |
Ultomiris | 593 | 52 | 62 | 4 | (6) | 8 | 365 | 71 | 134 | 34 | 53 | 90 | 23 | 52 |
Strensiq | 272 | 24 | 27 | 10 | 59 | 48 | 224 | 29 | 19 | (1) | 13 | 19 | (6) | 16 |
Koselugo | 58 | 74 | 77 | 3 | n/m | n/m | 48 | 51 | 7 | n/m | n/m | - | - | - |
Kanuma | 49 | 45 | 44 | 16 | n/m | n/m | 21 | 18 | 10 | (8) | 4 | 2 | 68 | n/m |
Other medicines | 379 | (7) | 7 | 180 | 1 | 12 | 32 | (11) | 28 | (23) | (19) | 139 | (12) | 11 |
Nexium | 300 | (9) | 7 | 131 | 1 | 13 | 26 | (12) | 9 | (40) | (32) | 134 | (13) | 9 |
Others | 79 | (1) | 5 | 49 | 1 | 8 | 6 | (2) | 19 | (12) | (10) | 5 | 34 | 70 |
Total Product Sales | 10,798 | (6) | 2 | 2,710 | (25) | (18) | 4,584 | 19 | 2,152 | (12) | 1 | 1,352 | (13) | 6 |
Table 27: Collaboration Revenue
FY 2022 | FY 2021 | ||
$m | $m | ||
Enhertu: alliance revenue | 519 | 193 | |
Tezspire: alliance revenue | 79 | - | |
Lynparza: regulatory milestones | 355 | - | |
Lynparza: sales milestones | - | 400 | |
Tralokinumab: sales milestones | 110 | - | |
Vaxzevria: royalties | 76 | 64 | |
Other royalty income | 72 | 74 | |
Other Collaboration Revenue | 142 | 145 | |
Total | 1,353 | 876 |
Table 28: Other Operating Income and Expense
FY 2022 | FY 2021 | ||
$m | $m | ||
Brazikumab licence termination funding | 138 | 99 | |
Waltham site gain on sale and leaseback | 125 | - | |
Divestment of rights to Plendil | 61 | - | |
Divestment of Viela Bio, Inc. shareholding | - | 776 | |
Crestor (Europe ex-UK and Spain) | - | 317 | |
Late stage small-molecule antibiotics assets (ex-US) | - | 100 | |
Other | 190 | 200 | |
Total | 514 | 1,492 |
Other shareholder information
Financial calendar
Announcement of first quarter 2023 results 27 April 2023
Announcement of half year and second quarter 2023 results 28 July 2023
Announcement of year to date and third quarter 2023 results 9 November 2023
Dividends are normally paid as follows:
First interim: Announced with the half year results and paid in September
Second interim: Announced with full year results and paid in March
The record date for the second interim dividend for 2022, payable on 27 March 2023, will be 24 February 2023. The ex-dividend date will be 23 February 2023.
Contacts
For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.
Addresses for correspondence
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1 Francis Crick Avenue Cambridge Biomedical Campus Cambridge CB2 0AA | Equiniti Limited Aspect House Spencer Road Lancing West Sussex BN99 6DA | Euroclear Sweden AB PO Box 191 SE-101 23 Stockholm | American Stock Transfer 6201 15th Avenue Brooklyn NY 11219
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United Kingdom | United Kingdom | Sweden | United States |
+44 (0) 20 3749 5000 | 0800 389 1580 | +46 (0) 8 402 9000 | +1 (888) 697 8018 |
+44 (0) 121 415 7033 | +1 (718) 921 8137 | ||
db@astfinancial.com
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Trademarks
Trademarks of the AstraZeneca group of companies appear throughout this document in italics. Medical publications also appear throughout the document in italics. AstraZeneca, the AstraZeneca logotype and the AstraZeneca symbol are all trademarks of the AstraZeneca group of companies. Trademarks of companies other than AstraZeneca that appear in this document include Arimidex and Casodex, owned by AstraZeneca or Juvisé (depending on geography); Beyfortus, a trademark of Sanofi Pasteur Inc.; Enhertu, a trademark of Daiichi Sankyo; Losec, owned by AstraZeneca or Cheplapharm (depending upon geography); Seloken, owned by AstraZeneca or Taiyo Pharma Co., Ltd (depending on geography); Synagis, owned by AstraZeneca or Sobi aka Swedish Orphan Biovitrum AB (publ). (depending on geography); and Tezspire, a trademark of Amgen, Inc.
Information on or accessible through AstraZeneca's websites, including astrazeneca.com, does not form part of and is not incorporated into this announcement.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.
Cautionary statements regarding forward-looking statements
In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act of 1995, AstraZeneca (hereafter 'the Group') provides the following cautionary statement:
This document contains certain forward-looking statements with respect to the operations, performance and financial condition of the Group, including, among other things, statements about expected revenues, margins, earnings per share or other financial or other measures. Although the Group believes its expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of preparation of this document and the Group undertakes no obligation to update these forward-looking statements. The Group identifies the forward-looking statements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in such statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond the Group's control, include, among other things:
‒ the ability of the Group and CinCor to complete the transactions contemplated by the acquisition agreement, including the parties' ability to satisfy the conditions to the consummation of the offer contemplated thereby and the other conditions set forth in the merger agreement;
‒ the Group's and CinCor's beliefs and expectations and statements about the benefits sought to be achieved in the Group's proposed acquisition of CinCor;
‒ the potential effects of the acquisition on both the Group and CinCor;
‒ the possibility of any termination of the acquisition agreement;
‒ the expected benefits and success of baxdrostat and any combination product, the possibility that the milestone related to the contingent value right will not be achieved;the risk of failure or delay in delivery of pipeline or launch of new medicines
‒ the risk of failure to meet regulatory or ethical requirements for medicine development or approval
‒ the risk of failures or delays in the quality or execution of the Group's commercial strategies
‒ the risk of pricing, affordability, access and competitive pressures
‒ the risk of failure to maintain supply of compliant, quality medicines
‒ the risk of illegal trade in the Group's medicines
‒ the impact of reliance on third-party goods and services
‒ the risk of failure in information technology or cybersecurity
‒ the risk of failure of critical processes
‒ the risk of failure to collect and manage data in line with legal and regulatory requirements and strategic objectives
‒ the risk of failure to attract, develop, engage and retain a diverse, talented and capable workforce
‒ the risk of failure to meet regulatory or ethical expectations on environmental impact, including climate change
‒ the risk of the safety and efficacy of marketed medicines being questioned
‒ the risk of adverse outcome of litigation and/or governmental investigations
‒ intellectual property-related risks to our products
‒ the risk of failure to achieve strategic plans or meet targets or expectations
‒ the risk of failure in financial control or the occurrence of fraud
‒ the risk of unexpected deterioration in the Group's financial position
‒ the impact that global and/or geopolitical events such as the COVID-19 pandemic and the Russia-Ukraine war may have or continue to have on these risks, on the Group's ability to continue to mitigate these risks, and on the Group's operations, financial results or financial condition
Nothing in this document, or any related presentation/webcast, should be construed as a profit forecast. There can be no guarantees that the conditions to the closing of the proposed transaction with CinCor will be satisfied on the expected timetable or at all or that baxdrostat or any combination product will receive the necessary regulatory approvals or prove to be commercially successful if approved.
- End of document -
[1] Constant exchange rates. The differences between Actual Change and CER Change are due to foreign exchange movements between periods in 2022 vs 2021. CER financial measures are not accounted for according to generally accepted accounting principles (GAAP) because they remove the effects of currency movements from Reported results.
[2] Reported financial measures are the financial results presented in accordance with UK-adopted International Accounting Standards and International Financial Reporting Standards (IFRSs) as issued by the International Accounting Standards Board (IASB) and International Accounting Standards as adopted by the European Union.
[3] Earnings per share.
[4] Core financial measures are adjusted to exclude certain items. The differences between Reported and Core measures are primarily due to costs relating to the acquisition of Alexion, amortisation of intangibles, impairments, restructuring charges, and, as previously disclosed, a charge to provisions relating to a legal settlement with Chugai Pharmaceutical Co. Ltd (Chugai) that led to a payment of $775m in Q2 2022. A full reconciliation between Reported EPS and Core EPS is provided in Tables 11 and 12 in the Financial performance section of this document.
[5] Cardiovascular, Renal and Metabolism.
[6] FY 2022 growth rates on medicines acquired with Alexion have been calculated on a pro forma basis comparing to the corresponding period in the prior year. In FY 2022, Total Revenue from Koselugo is included in Rare Disease (FY 2021: Oncology) and Total Revenue from Andexxa is included in BioPharmaceuticals: CVRM (FY 2021: Rare Disease). The growth rate shown for each therapy area has been calculated as though these changes had been implemented in FY 2021.
[7] Respiratory & Immunology.
[8] The COVID-19 medicines are Vaxzevria, Evusheld, and AZD3152 - the COVID-19 antibody currently in development.
[9] AstraZeneca is collaborating with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza.
[10] Metastatic castration-resistant prostate cancer.
[11] Human epidermal growth factor receptor 2.
[12] Hepatocellular carcinoma.
[13] Non-small cell lung cancer.
[14] Mesenchymal-epithelial transition.
[15] Long-acting antibody.
[16] Vaxzevria is AstraZeneca's trademark for the Company's supply of the AstraZeneca COVID-19 Vaccine. In the financial tables in this report, 'Vaxzevria Total Revenue' includes Collaboration Revenue from sub-licensees that produce and supply the AstraZeneca COVID‑19 Vaccine under their own trademarks.
[17] Volume-based procurement.
[18] Vaccines & Immune Therapies.
[19] In Table 2, the plus and minus symbols denote the directional impact of the item being discussed, e.g. a '+' symbol next to a R&D expense comment indicates that the item increased the R&D expense relative to the prior year.
[20] Gross Profit is defined as Total Revenue minus Cost of sales. The calculation of Reported and Core Gross Margin excludes the impact of Collaboration Revenue.
[21] Where AstraZeneca does not retain a significant ongoing interest in medicines or potential new medicines, income from divestments is reported within Reported and Core Other operating income and expense in the Company's financial statements.
[22] Chronic lymphocytic leukaemia.
[23] Heart failure with preserved ejection fraction.
[24] Respiratory syncytial virus.
[25] Neuromyelitis optica spectrum disorder.
[26] Hormone receptor.
[27] US Food and Drug Administration.
[28] Imfinzi Product Sales includes sales of Imjudo, which commenced in Q4 2022.
[29] Alliance revenue (previously referred to as share of gross profits) comprises income arising from collaborative arrangements, where AstraZeneca is entitled to a profit share, but does not include product sales where AstraZeneca is leading commercialisation in a territory. Alliance revenue is included within Collaboration Revenue.
[30] National reimbursement drug list.
[31] France, Germany, Italy, Spain, UK.
[32] Extensive-stage small cell lung cancer.
[33] Biliary tract cancer.
[34] Poly ADP ribose polymerase.
[35] Germline (hereditary) breast cancer gene mutation.
[36] Breast cancer gene mutation.
[37] Metastatic castration resistant prostate cancer.
[38] European Medicines Agency.
[39] Bruton tyrosine kinase inhibitor.
[40] Tyrosine kinase inhibitor.
[41] Sodium-glucose cotransporter 2.
[42] Heart failure.
[43] European Society of Cardiology.
[44] American Heart Association.
[45] American College of Cardiology.
[46] Heart Failure Society of America.
[47] Heart failure with reduced ejection fraction.
[48] Type-2 diabetes.
[49] Betaloc is the brand name for Seloken in China.
[50] Inhaled corticosteroid.
[51] Long-acting beta-agonist.
[52] Interleukin-5.
[53] The 'dynamic market' refers to patients who have recently changed their medicine to a branded biologic. It captures patients who have adopted a biologic medicine for the first time, and patients who have switched from one biologic brand to another.
[54] Fixed dose combination.
[55] 'New-to-brand' share represents a medicine's share in the dynamic market
[56] Intravenous injection.
[57] Systemic lupus erythematosus.
[58] Complement component 5.
[59] Paroxysmal nocturnal haemoglobinuria.
[60] Atypical haemolytic uraemic syndrome.
[61] Generalised myasthenia gravis.
[62] Other Operating Income.
[63] Other SG&A expense of $985m predominantly includes the $775m charge to provisions relating to the legal settlement with Chugai and $82m of fair value movements on contingent consideration arising from business combinations.
[64] Other Taxation of ($1,049m) includes a one-off favourable net adjustment of ($876m) to deferred taxes arising from an internal reorganisation to integrate the Alexion organisation.
[65] Securities Exchange Commission.
[66] Based on best prevailing assumptions around currency profiles.
[67] Based on average daily spot rates 1 Jan 2022 to 31 Dec 2022
[68] Based on average daily spot rates 1 Jan 2023 to 31 Jan 2023.
[69] Other currencies include AUD, BRL, CAD, KRW and RUB.
[70] Epidermal growth factor receptor.
[71] Programmed death-ligand 1.
[72] Prescription Drug User Fee Act.
[73] Supplemental new drug application.
[74] Overall survival.
[75] Ado-trastuzumab emtansine.
[76] Overall response rate.
[77] The table provides an analysis of year-on-year Product Sales, with Actual and CER growth rates reflecting year-on-year growth. Due to rounding, the sum of a number of dollar values and percentages may not agree to totals. *FY 2022 growth rates on medicines acquired with Alexion have been calculated on a pro forma basis comparing to the corresponding period in the prior year. The growth rates shown for Rare Disease and CVRM therapy area totals include these pro forma adjustments.
[78] The table provides an analysis of year-on-year Product Sales, with Actual and CER growth rates reflecting year-on-year growth. Due to rounding, the sum of a number of dollar values and percentages may not agree to totals.