FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
 
For the month of February 2023
 
Commission File Number: 001-11960
 
AstraZeneca PLC
 
1 Francis Crick Avenue
Cambridge Biomedical Campus
Cambridge CB2 0AA
United Kingdom
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
 
Form 20-F X Form 40-F __
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______
 
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
 
Yes __ No X
 
If “Yes” is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b): 82-_____________
 
 
 
 
AstraZeneca PLC
 
INDEX TO EXHIBITS
 
1.
Final Results
 
 
 
 
 
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 
CER1
$m 
Actual 
CER 
- Product Sales 
 
42,998 
18 
24 
10,798 
(6)
- Collaboration Revenue 
 
1,353 
54 
56 
409 
(20)
(19)
Total Revenue 
 
44,351 
19 
25 
11,207 
(7)
Reported2 EPS3
 
$2.12 
n/m 
n/m 
$0.58 
n/m 
n/m 
Core4 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 CVRM5 increased 19%6, R&I7 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 medicines8 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 Lynparza9 in mCRPC10 (PROpel), Enhertu in gastric cancer (DESTINY-Gastric01) and HER211-low breast cancer (DESTINY-Breast04), Imfinzi in biliary tract cancer (TOPAZ-1), Imfinzi+Imjudo in HCC12 and Forxiga in heart failure with preserved ejection fraction. Five approvals in Japan, including Imfinzi and Imjudo in liver cancer (TOPAZ-1) and NSCLC13 (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 MET14 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 LAAB15 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)
 
* Decline of 6% (2% increase at CER) due to lower sales of Vaxzevria16
 
*     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)
 
*    Excluding Vaxzevria, Q4 2022 Total Revenue increased by 8% (17% at CER) - see below
 
 
Therapy areas 
 
$m 
Actual 
CER 
 
 
Oncology 
 
4,046 
12 
 
*    Strong performance across key medicines and regions
 
 
CVRM
 
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 VBP17 implementation in
      China

 
 
V&I18
 
1,163 
(50)
(43)
 
*    $734m from Evusheld (Q4 2021: $135m)
 
*    $95m from Vaxzevria (Q4 2021: $1,762m)
 

Rare Disease
 
1,816 
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)
 
 
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)
 
*    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)
 
 
Total Revenue inc. Vaxzevria
 
11,207 
(7)
 
 
Regions exc. Vaxzevria 
 
$m 
Actual 
CER 
 
 
Emerging Markets 
 
2,678 
18 
 
 
- China 
 
1,194 
(8)
 
*    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)
 
 
Established RoW 
 
1,378 
27 
 
 
Total Revenue exc. Vaxzevria
 
11,112 
17 
 
 
 
Table 2: Key elements of financial performance in Q4 2022
 
 
Metric
Reported
Reported change
Core
Core change
 
Comments19
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 margin20
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 income21
$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
CLL22 (ELEVATE-TN)
Regulatory approval (JP)
 
Calquence
Maleate tablet formulation
Regulatory approval (EU)
 
Forxiga
HFpEF23 (DELIVER)
Regulatory approval (EU, JP)
 
Airsupra
Severe asthma (MANDALA/DENALI)
Regulatory approval (US)
 
Tezspire
Pre-filled pen
Regulatory approval (US, EU)
Regulatory submissions or acceptances
 
Enhertu
HER2-mutated NSCLC (2nd-line+) (DESTINY-Lung01)
Regulatory submission (EU, JP)
Calquence
CLL (ASCEND)
Regulatory submission (CN)
Beyfortus
RSV24 (MELODY/MEDLEY)
Regulatory submission (US)
Soliris
NMOSD25
Regulatory submission (CN)
Major Phase III data readouts and other developments
Imfinzi
NSCLC (1st-line) (PEARL)
Primary endpoint not met
capivasertib
HR26+/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 FDA27
 
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 
18 
- Tagrisso 
 
5,444 
12 
15 
1,342 
12 
12 
- Imfinzi 28
 
2,784 
15 
21 
752 
19 
27 
- Lynparza 
 
2,638 
12 
18 
689 
10 
17 
- Calquence 
 
2,057 
66 
69 
588 
49 
53 
- Enhertu 
 
79 
>4x 
>4x 
28 
>3x 
>3x 
- Orpathys 
 
33 
>2x 
>2x 
(1)
n/m 
n/m 
- Zoladex 
 
927 
(2)
210 
(9)
- Faslodex 
 
334 
(22)
(14)
74 
(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
 
9,188 
21 
13 
19 
2,281 
20 
12 
22 
- Farxiga 
 
4,381 
10 
46 
56 
1,177 
11 
39 
52 
- Brilinta 
 
1,358 
(8)
(4)
345 
(1)
- Lokelma 
 
289 
65 
75 
81 
50 
63 
- Roxadustat 
 
197 
13 
18 
49 
65 
87 
- Andexxa
 
150 
14 
39 
14 
- Crestor 
 
1,048 
(4)
224 
(13)
(2)
- Seloken/Toprol-XL 
 
862 
(9)
(4)
157 
(23)
(12)
- Bydureon
 
280 
(27)
(26)
73 
(20)
(20)
- Onglyza
 
257 
(28)
(25)
52 
(31)
(24)
- Others 
 
366 
(10)
(7)
84 
(13)
(6)
BioPharmaceuticals: R&I 
 
5,765 
13 
(4)
- 
1,447 
13 
(9)
(3)
- Symbicort 
 
2,538 
(7)
(2)
620 
(9)
(2)
- Fasenra
 
1,396 
11 
15 
381 
12 
- Breztri  
 
398 
96 
>2x 
116 
59 
68 
- Saphnelo 
 
116 
>10x 
>10x 
48 
>6x
>6x
- Tezspire 
 
n/m 
n/m 
n/m 
n/m 
- Pulmicort 
 
645 
(33)
(31)
166 
(33)
(28)
- Daliresp/Daxas 
 
189 
(17)
(16)
28 
(52)
(52)
- Bevespi
 
58 
14 
(5)
(1)
- Others 
 
421 
(29)
(27)
70 
(53)
(47)
BioPharmaceuticals: V&I 
 
4,736 
11 
1,129 
10 
(51)
(44)
- Vaxzevria 
 
1,798 
(54)
(52)
85 
(95)
(94)
- Evusheld 
 
2,185 
>10x 
>10x 
734 
>8x 
>9x 
- Synagis
 
578 
41 
59 
194 
(19)
(3)
- FluMist
 
175 
(31)
(20)
116 
(35)
(24)
Rare Disease
 
7,053 
16 
10 
1,816 
16 
10 
- Soliris
 
3,762 
(11)
(5)
844 
(22)
(16)
- Ultomiris
 
1,965 
34 
42 
593 
52 
62 
- Strensiq
 
958 
16 
18 
272 
24 
27 
- Koselugo 
 
208 
93 
96 
58 
74 
77 
- Kanuma
 
160 
16 
19 
49 
45 
44 
Other Medicines 
 
1,625 
(5)
379 
(7)
- Nexium 
 
1,285 
(3)
300 
(9)
- Others 
 
340 
(10)
(7)
79 
(1)
Product Sales 
 
42,998 
97 
18 
24 
10,798 
96 
(6)
Collaboration Revenue 
 
1,353 
54 
56 
409 
(20)
(19)
Total Revenue
 
44,351 
100 
19 
25 
11,207 
100 
(7)
 
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 
12 
BioPharmaceuticals 6 
 
20,010 
45 
11 
4,932 
44 
(17)
(9)
- CVRM6 
 
9,211 
21 
13 
19 
2,284 
20 
12 
22 
- R&I 
 
5,963 
13 
(1)
1,485 
13 
(7)
(1)
- V&I 
 
4,836 
11 
1,163 
10 
(50)
(43)
Rare Disease6
 
7,053 
16 
10 
1,816 
16 
10 
Other Medicines 
 
1,748 
(4)
412 
(2)
12 
Total
 
44,351 
100 
19 
25 
11,207 
100 
(7)
 
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)
2,733 
24 
(25)
(18)
- China 
 
5,792 
13 
(4)
1,194 
11 
(9)
- Ex-China 
 
5,953 
13 
(5)
1,538 
14 
(35)
(29)
US 
 
17,920 
40 
47 
47 
4,788 
43 
22 
22 
Europe 
 
8,738 
20 
21 
2,308 
21 
(20)
(8)
Established RoW 
 
5,948 
13 
22 
40 
1,378 
12 
(11)
Total 
 
44,351 
100 
19 
25 
11,207 
100 
(7)
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 
18 
- China 
 
5,746 
13 
(4)
(1)
1,194 
11 
(8)
- 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)
Established RoW 
 
5,323 
12 
24 
43 
1,378 
12 
27 
Total 
 
42,476 
96 
27 
34 
11,112 
99 
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 NRDL30 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 EU531, 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-SCLC32
 
*    Strong launch in BTC33 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 PARP34 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 gBRCAm35 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 BRCAm36 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 mCRPC37 and gBRCAm HER2-negative advanced breast cancer and the EU launch in gBRCAm early breast cancer following EMA38 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 BTKi39 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 TKIs40
 
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 SGLT241 market in all major regions
 
*    Additional benefit from continued growth in the overall SGLT2 inhibitor class
 
*    Further HF42 and CKD launches and supportive updates to treatment guidelines including from ESC43 and AHA44/ACC45/HFSA46. 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 HFrEF47 in May 2020, treatment of CKD in May 2021. Both approvals included patients with and without T2D48
 
*    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 Betaloc49 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 ICS50/LABA51 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-552 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 market53 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 FDC54 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-brand55 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 SLE57 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 C558 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 PNH59, aHUS60 and gMG61, 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 
OOI62 & 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
Acquisition of 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 
98563 
(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
Acquisition of 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 underlying
improvement 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 SEC65 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
 
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 in FY average rate vs. USD ($m) 66
 
Currency 
Primary Relevance 
 
FY    202267
Jan    202368
Change 
 (%)
 
Total Revenue 
Core Operating Profit 
EUR
Total Revenue
 
0.95 
0.93 
 
323 
159 
CNY
Total Revenue
 
6.74 
6.79 
(1)
 
309 
174 
JPY
Total Revenue
 
131.59 
130.37 
 
181 
122 
Other69
 
 
 
 
 
 
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 EGFR70 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-L171, 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)
 
PDUFA72 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 sNDA73 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)