1
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
increased 19%
, R&I
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
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.”
2
Key milestones achieved since the prior results
‒ Key regulatory approvals: US approval for Airsupra (PT027) in asthma. EU approvals for Lynparza
in
mCRPC
(PROpel), Enhertu in gastric cancer (DESTINY-Gastric01) and HER2
-low breast cancer
(DESTINY-Breast04), Imfinzi in biliary tract cancer (TOPAZ-1), Imfinzi+Imjudo in HCC
and Forxiga in heart
failure with preserved ejection fraction. Five approvals in Japan, including Imfinzi and Imjudo in liver cancer
(TOPAZ-1) and NSCLC
(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
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
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.
3
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
CVRM
6
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 Disease
6
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
4
Table 2: Key elements of financial performance in Q4 2022
Metric
Reported
Reported
change
Core
Core
change
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 Expenses
commentary 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
5
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
submissions
or 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
6
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.
7
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.
8
Notes
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.
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.
Earnings per share.
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.
Cardiovascular, Renal and Metabolism.
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.
Respiratory & Immunology.
The COVID-19 medicines are Vaxzevria, Evusheld, and AZD3152 – the COVID-19 antibody currently in development.
AstraZeneca is collaborating with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza.
Metastatic castration-resistant prostate cancer.
Human epidermal growth factor receptor 2.
Hepatocellular carcinoma.
Non-small cell lung cancer.
Mesenchymal-epithelial transition.
Long-acting antibody.
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.
Volume-based procurement.
Vaccines & Immune Therapies.
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.
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.
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.
Chronic lymphocytic leukaemia.
Heart failure with preserved ejection fraction.
Respiratory syncytial virus.
Neuromyelitis optica spectrum disorder.
Hormone receptor.
US Food and Drug Administration.
9
Contents
Operating and financial review ................................................................................................................................... 10
Financial performance................................................................................................................................................ 22
Sustainability .............................................................................................................................................................. 29
Research and development ....................................................................................................................................... 30
Condensed Consolidated Financial Statements ........................................................................................................ 35
Notes to the Condensed Consolidated Financial Statements .................................................................................... 40
Other shareholder information ................................................................................................................................... 49
List of tables
Table 1: Key elements of Total Revenue performance in Q4 2022 ............................................................................. 3
Table 2: Key elements of financial performance in Q4 2022 ....................................................................................... 4
Table 3: Pipeline highlights since prior results announcement .................................................................................... 5
Table 4: Therapy area and medicine performance .................................................................................................... 11
Table 5: Collaboration Revenue................................................................................................................................. 12
Table 6: Total Revenue by therapy area .................................................................................................................... 12
Table 7: Total Revenue by region .............................................................................................................................. 12
Table 8: Total Revenue by region – excluding Vaxzevria .......................................................................................... 12
Table 9: Reported Profit and Loss ............................................................................................................................. 22
Table 10: Reconciliation of Reported Profit before tax to EBITDA............................................................................. 22
Table 11: Reconciliation of Reported to Core financial measures: FY 2022 .............................................................. 23
Table 12: Reconciliation of Reported to Core financial measures: Q4 2022 ............................................................. 23
Table 13: Cash Flow summary .................................................................................................................................. 25
Table 14: Net Debt summary ..................................................................................................................................... 26
Table 15: Obligor group summarised Statement of comprehensive income ............................................................. 27
Table 16: Obligor group summarised Statement of financial position ........................................................................ 27
Table 17: Currency sensitivities ................................................................................................................................. 28
Table 18: Condensed consolidated statement of comprehensive income: FY 2022 ................................................. 35
Table 19: Condensed consolidated statement of comprehensive income: Q4 2022 ................................................. 36
Table 20: Condensed consolidated statement of financial position ........................................................................... 37
Table 21: Condensed consolidated statement of changes in equity .......................................................................... 38
Table 22: Condensed consolidated statement of cash flows ..................................................................................... 39
Table 23: Net Debt ..................................................................................................................................................... 41
Table 24: Financial instruments - contingent consideration ....................................................................................... 42
Table 25: FY 2022 - Product Sales year-on-year analysis......................................................................................... 47
Table 26: Q4 2022 - Product Sales year-on-year analysis ........................................................................................ 48
Table 27: Collaboration Revenue............................................................................................................................... 49
Table 28: Other Operating Income and Expense....................................................................................................... 49
10
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.
11
Total Revenue
Financial Performance
Sustainability
Condensed Financial Statements
Research and Development
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
Imfinzi Product Sales includes sales of Imjudo, which commenced in Q4 2022.
12
Total Revenue
Financial Performance
Sustainability
Condensed Financial Statements
Research and Development
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)
- CVRM
6
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 Disease
6
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
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.
13
Total Revenue
Financial Performance
Sustainability
Condensed Financial Statements
Research and Development
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
National reimbursement drug list.
France, Germany, Italy, Spain, UK.
Extensive-stage small cell lung cancer.
Biliary tract cancer.
14
Total Revenue
Financial Performance
Sustainability
Condensed Financial Statements
Research and Development
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)
Poly ADP ribose polymerase.
Germline (hereditary) breast cancer gene mutation.
Breast cancer gene mutation.
Metastatic castration resistant prostate cancer.
European Medicines Agency.
15
Total Revenue
Financial Performance
Sustainability
Condensed Financial Statements
Research and Development
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%).
Bruton tyrosine kinase inhibitor.
Tyrosine kinase inhibitor.
16
Total Revenue
Financial Performance
Sustainability
Condensed Financial Statements
Research and Development
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.
Sodium-glucose cotransporter 2.
Heart failure.
European Society of Cardiology.
American Heart Association.
American College of Cardiology.
Heart Failure Society of America.
Heart failure with reduced ejection fraction.
Type-2 diabetes.
17
Total Revenue
Financial Performance
Sustainability
Condensed Financial Statements
Research and Development
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
Betaloc is the brand name for Seloken in China.
Inhaled corticosteroid.
Long-acting beta-agonist.
18
Total Revenue
Financial Performance
Sustainability
Condensed Financial Statements
Research and Development
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.
segment for SLE
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.
Interleukin-5.
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.
Fixed dose combination.
‘New-to-brand’ share represents a medicine’s share in the dynamic market
Intravenous injection.
Systemic lupus erythematosus.
19
Total Revenue
Financial Performance
Sustainability
Condensed Financial Statements
Research and Development
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
20
Total Revenue
Financial Performance
Sustainability
Condensed Financial Statements
Research and Development
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
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 change
6
(11%)
(29%)
(7%)
(21%)
11%
CER change
6
(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 change
6
34%
>2x
35%
49%
6%
CER change
6
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
Complement component 5.
Paroxysmal nocturnal haemoglobinuria.
Atypical haemolytic uraemic syndrome.
Generalised myasthenia gravis.
21
Total Revenue
Financial Performance
Sustainability
Condensed Financial Statements
Research and Development
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%)
22
Total Revenue
Financial Performance
Sustainability
Condensed Financial Statements
Research and Development
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
61
& 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.
Other Operating Income.
23
Total Revenue
Financial Performance
Sustainability
Condensed Financial Statements
Research and Development
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
985
62
(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)
63
(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)
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.
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.
24
Total Revenue
Financial Performance
Sustainability
Condensed Financial Statements
Research and Development
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
25
Total Revenue
Financial Performance
Sustainability
Condensed Financial Statements
Research and Development
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)
26
Total Revenue
Financial Performance
Sustainability
Condensed Financial Statements
Research and Development
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.
27
Total Revenue
Financial Performance
Sustainability
Condensed Financial Statements
Research and Development
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
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
$m
Current assets
4
Non-current assets
-
Current liabilities
(2,839)
Non-current liabilities
(22,797)
Amounts due from subsidiaries that are not issuers or guarantors
7,806
Amounts due to subsidiaries that are not issuers or guarantors
(293)
Securities Exchange Commission.
28
Total Revenue
Financial Performance
Sustainability
Condensed Financial Statements
Research and Development
Foreign exchange
The Company’s transactional currency exposures on working-capital balances, which typically extend for up to
three months, are hedged where practicable using forward foreign exchange contracts against the individual
companies’ reporting currency. Foreign exchange gains and losses on forward contracts for transactional
hedging are taken to profit or loss. In addition, the Company’s external dividend payments, paid principally in
pounds sterling and Swedish krona, are fully hedged from announcement to payment date.
Table 17: Currency sensitivities
The Company provides the following currency-sensitivity information:
Average spot
rates vs. USD
Annual impact of 5%
strengthening in
FY average rate vs.
USD ($m)
65
Currency
Primary Relevance
FY
2022
66
Jan
2023
67
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
68
385
202
GBP
Operating expense
0.81
0.82
(1)
46
(92)
SEK
Operating expense
10.12
10.39
(3)
7
(55)
Based on best prevailing assumptions around currency profiles.
Based on average daily spot rates 1 Jan 2022 to 31 Dec 2022
Based on average daily spot rates 1 Jan 2023 to 31 Jan 2023.
Other currencies include AUD, BRL, CAD, KRW and RUB.
29
Total Revenue
Financial Performance
Sustainability
Condensed Financial Statements
Research and Development
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
30
Research and Development
Condensed Financial Statements
Total Revenue
Financial Performance
Sustainability
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
69
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
70
, or in a subgroup
of patients at low risk of early mortality. (December 2022)
Lynparza
Epidermal growth factor receptor.
Programmed death-ligand 1.
31
Research and Development
Condensed Financial Statements
Total Revenue
Financial Performance
Sustainability
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
71
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
72
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
73
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
74
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
75
of 32% including one
complete response, 13 partial responses and 18 cases of stable disease as
Prescription Drug User Fee Act.
Supplemental new drug application.
Overall survival.
Ado-trastuzumab emtansine.
Overall response rate.
32
Research and Development
Condensed Financial Statements
Total Revenue
Financial Performance
Sustainability
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)
33
Research and Development
Condensed Financial Statements
Total Revenue
Financial Performance
Sustainability
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)
34
Research and Development
Condensed Financial Statements
Total Revenue
Financial Performance
Sustainability
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 V
H
H 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
<1.5xULN and prevented clinically significant EVH, demonstrated by 3.9 g/dL
increase in Hgb level and ARC reduction.
35
Total Revenue
Financial Performance
Sustainability
Research and Development
Condensed Financial Statements
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
36
Total Revenue
Financial Performance
Sustainability
Research and Development
Condensed Financial Statements
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
37
Total Revenue
Financial Performance
Sustainability
Research and Development
Condensed Financial Statements
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
38
Total Revenue
Financial Performance
Sustainability
Research and Development
Condensed Financial Statements
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
39
Total Revenue
Financial Performance
Sustainability
Research and Development
Condensed Financial Statements
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
40
Total Revenue
Financial Performance
Sustainability
Research and Development
Condensed Financial Statements
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.
41
Total Revenue
Financial Performance
Sustainability
Research and Development
Condensed 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.
42
Total Revenue
Financial Performance
Sustainability
Research and Development
Condensed Financial Statements
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.
43
Total Revenue
Financial Performance
Sustainability
Research and Development
Condensed Financial Statements
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.
44
Total Revenue
Financial Performance
Sustainability
Research and Development
Condensed Financial Statements
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.
45
Total Revenue
Financial Performance
Sustainability
Research and Development
Condensed Financial Statements
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.
46
Total Revenue
Financial Performance
Sustainability
Research and Development
Condensed Financial Statements
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.
47
Table 25: FY 2022 - Product Sales year-on-year analysis
76
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
76
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.
48
Table 26: Q4 2022 - Product Sales year-on-year analysis
77
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
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.
49
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.
50
Addresses for correspondence
Registered office
Registrar and
transfer office
Swedish Central
Securities Depository
US depositary
Deutsche Bank Trust
Company Americas
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
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
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.
51
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 -