FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For
the month of February 2023
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
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
|
|
$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
|
|
|
$2.12
|
n/m
|
n/m
|
$0.58
|
n/m
|
n/m
|
|
|
$6.66
|
26
|
33
|
$1.38
|
(17)
|
(5)
|
Financial performance (FY 2022 figures
unless otherwise stated, growth numbers and commentary at
CER)
-
Total Revenue increased 25% to $44,351m, with growth coming from
all therapy areas, and from the addition of Alexion, which was
incorporated into the Group's results from 21 July 2021
-
Total Revenue in the fourth quarter was impacted by the decline
in Vaxzevria. Excluding Vaxzevria, Total Revenue in the quarter increased
17%
-
Oncology Total Revenue including milestone receipts increased 20%;
Oncology Product Sales increased 19%. Total Revenue
CVRM5 increased 19%6, R&I7 increased 3%, and Rare Disease increased
10%6
-
Core Gross Margin of 80%, up six percentage points, reflecting the
lower revenue from Vaxzevria and the increased share of Oncology and Rare
Disease medicines. Core Gross Margin of 77% in the fourth quarter
was impacted by inventory write downs and manufacturing termination
fees for Evusheld
-
Core Total Operating Expense increased 23%, reflecting the addition
of Alexion, and continued investment in new launches and the
pipeline to deliver sustainable long-term growth
-
Core Operating Margin of 30%, up four percentage points
-
Core EPS increased 33% to $6.66. Second interim dividend declared
of $1.97 per share, making a total dividend declared for FY 2022 of
$2.90 for the year. The Core Tax Rate for the year was 17%,
reflecting IP incentive regimes, geographical mix of profits and
adjustments to prior year tax liabilities
FY 2023 Guidance summary (Growth numbers
at CER)
-
Total Revenue is expected to increase by a low-to-mid single-digit
percentage
-
Total Revenue excluding COVID-19 medicines8 is expected to increase by a low double-digit
percentage
-
Core EPS is expected to increase by a high single-digit to low
double-digit percentage
Pascal
Soriot, Chief Executive Officer, AstraZeneca, said:
"2022 was a year of continued strong company performance and
execution of our long-term growth strategy. We made excellent
pipeline progress with a record 34 approvals in major markets and
we are initiating new late-stage trials for high potential
medicines such as camizestrant, datopotamab deruxtecan and
volrustomig.
In 2023, we expect to see another year of double-digit revenue
growth at CER, excluding our COVID-19 medicines. We will continue
to invest behind our pipeline and recent launches while continuing
to improve profitability. We plan to initiate more than thirty
Phase III trials this year, of which ten have the potential to
deliver peak year sales over one billion dollars.
Our R&D success and revenue increase in 2022 demonstrate that
we are on track to deliver industry-leading revenue growth through
2025 and beyond, and have set AstraZeneca on a path to deliver at
least fifteen new medicines before the end of the
decade."
Key
milestones achieved since the prior results
-
Key regulatory approvals: US approval for Airsupra (PT027) in asthma. EU approvals for
Lynparza9 in mCRPC10 (PROpel), Enhertu in gastric cancer (DESTINY-Gastric01) and
HER211-low breast cancer (DESTINY-Breast04),
Imfinzi
in biliary tract cancer
(TOPAZ-1), Imfinzi+Imjudo in HCC12 and Forxiga in heart failure with preserved ejection fraction.
Five approvals in Japan, including Imfinzi and Imjudo in liver cancer (TOPAZ-1) and
NSCLC13 (POSEIDON) and Calquence for treatment-naïve CLL (ELEVATE-TN)
-
Other regulatory milestones: US Fast Track designations for
capivasertib in HR-positive HER2-negative breast cancer
(CAPItello-291), tozorakimab in treatment/prevention of acute
respiratory failure in patients with viral lung infection (TILIA),
and Orpathys plus Tagrisso in NSCLC with MET14 overexpression (SAVANNAH/SAFFRON); US Orphan Drug
Designation for Saphnelo in idiopathic inflammatory myopathies; US
Emergency Use Authorisation for Evusheld revised - as of January 2023, Evusheld is not currently authorised for use in the
US.
The
Company provides guidance for FY 2023 at CER, based on the average
exchange rates through 2022.
Total Revenue is expected to increase by a low-to-mid single-digit
percentage
Excluding
COVID-19 medicines, Total Revenue is expected to increase by a low
double-digit percentage
Core EPS is expected to increase by a high single-digit to low
double-digit percentage
-
While challenging to forecast, Total Revenue from COVID-19
medicines (Vaxzevria, Evusheld
and AZD3152, the COVID-19
LAAB15 currently in development) is expected to decline
significantly in FY 2023, with minimal revenue from
Vaxzevria
-
Total Revenue from China is expected to return to growth and
increase by a low single-digit percentage in FY 2023
-
Collaboration Revenue and Other Operating Income are both expected
to increase, driven by continued growth of our partnered medicines,
success-based milestones, and certain anticipated
transactions
-
Core Operating Expenses are expected to increase by a low-to-mid
single-digit percentage, driven by investment in recent launches
and the ungating of new trials
-
The Core Tax Rate is expected to be between 18-22%
The
Company is unable to provide guidance on a Reported basis because
it cannot reliably forecast material elements of the Reported
result, including any fair value adjustments arising on
acquisition-related liabilities, intangible asset impairment
charges and legal settlement provisions. Please refer to the
cautionary statements section regarding forward-looking statements
at the end of this announcement.
Currency
impact
If
foreign exchange rates for February to December 2023 were to remain
at the average rates seen in January 2023, it is anticipated that
FY 2023 Total Revenue and FY 2023 Core EPS would both incur a low
single-digit adverse impact versus the performance at
CER.
The
Company's foreign exchange rate sensitivity analysis is provided in
Table 17.
Table 1: Key elements of Total Revenue performance in Q4
2022
Revenue
type
|
|
$m
|
Actual
|
CER
|
|
|
Product
Sales
|
|
10,798
|
(6)
|
2
|
|
* Decline of 6% (2% increase at CER) due to lower
sales of Vaxzevria16
* Strong
growth in Oncology, CVRM and Rare Disease
|
Collaboration
Revenue
|
|
409
|
(20)
|
(19)
|
|
* $188m for Enhertu (Q4 2021: $60m)
* $37m for Tezspire (Q4 2021: $nil)
* Milestone of $105m for Lynparza
|
Total
Revenue
|
|
11,207
|
(7)
|
1
|
|
* Excluding Vaxzevria, Q4 2022 Total Revenue increased by 8% (17% at CER)
- see below
|
Therapy
areas
|
|
$m
|
Actual
|
CER
|
|
|
Oncology
|
|
4,046
|
4
|
12
|
|
* Strong
performance across key medicines and regions
|
CVRM6
|
|
2,284
|
12
|
22
|
|
* Farxiga up 39% (52% CER), Lokelma up 50% (63% at CER), roxadustat up 61% (83%
CER), Brilinta decreased 1% (increased 4% at
CER)
|
R&I
|
|
1,485
|
(7)
|
(1)
|
|
* Growth in Fasenra, Breztri and Saphnelo offset by decline in Pulmicort of 33% (28% at CER) primarily due to the impact of
VBP17 implementation in
China
|
|
|
1,163
|
(50)
|
(43)
|
|
* $734m from Evusheld (Q4 2021: $135m)
* $95m from Vaxzevria (Q4 2021: $1,762m)
|
Rare
Disease6
|
|
1,816
|
4
|
10
|
|
* Ultomiris up 52% (62% at CER) as gMG launch and conversion
progressed; offset by decline in Soliris
* Strensiq up 24% (27% at CER) reflecting strength of patient
demand and geographic expansion
|
Other
Medicines
|
|
412
|
(2)
|
12
|
|
|
Total
Revenue
|
|
11,207
|
(7)
|
1
|
|
|
Regions inc.
Vaxzevria
|
|
$m
|
Actual
|
CER
|
|
|
Emerging
Markets
|
|
2,733
|
(25)
|
(18)
|
|
* Decline due to lower sales of Vaxzevria (growth rates excluding Vaxzevria shown below)
|
-
China
|
|
1,194
|
(9)
|
3
|
|
* Second
consecutive quarter of growth at CER
|
-
Ex-China Emerging Markets
|
|
1,538
|
(35)
|
(29)
|
|
* Decline due to lower sales of Vaxzevria
|
US
|
|
4,788
|
22
|
22
|
|
|
Europe
|
|
2,308
|
(20)
|
(8)
|
|
* Decline due to lower sales of Vaxzevria
|
Established
RoW
|
|
1,378
|
(11)
|
8
|
|
|
Total
Revenue inc.
Vaxzevria
|
|
11,207
|
(7)
|
1
|
|
|
Regions exc.
Vaxzevria
|
|
$m
|
Actual
|
CER
|
|
|
Emerging
Markets
|
|
2,678
|
7
|
18
|
|
|
-
China
|
|
1,194
|
(8)
|
4
|
|
* Second
consecutive quarter of growth at CER
|
-
Ex-China Emerging Markets
|
|
1,484
|
24
|
33
|
|
* Strong
growth in Oncology and CVRM
* $246m from Evusheld in Q4 (Q4 2021: $69m)
|
US
|
|
4,788
|
24
|
24
|
|
*
Growth in Oncology medicines
|
Europe
|
|
2,268
|
(12)
|
1
|
|
|
Established
RoW
|
|
1,378
|
4
|
27
|
|
|
Total
Revenue exc. Vaxzevria
|
|
11,112
|
8
|
17
|
|
|
Table 2: Key elements of financial performance in Q4
2022
Metric
|
Reported
|
Reported
change
|
Core
|
Core
change
|
|
|
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
|
|
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
|
|
$189m
|
29%
Actual 33% CER
|
$130m
|
-11%
Actual -7% CER
|
|
* Reported and Core OOI includes income from sale of
the Waltham site
|
Operating
margin
|
10%
|
12pp
Actual 14pp CER
|
23%
|
-4pp
Actual -3pp CER
|
|
* See
Gross Margin and Expensescommentary above
|
Net
finance expense
|
$315m
|
-6%
Actual stable at CER
|
$245m
|
5%
Actual 9% CER
|
|
* Reported
impacted by a reduction in the discount unwind on
acquisition-related liabilities
|
Tax
rate
|
-16%
|
n/m
|
10%
|
-7pp
Actual -6pp CER
|
|
* The Reported and Core Tax Rates in the quarter
reflected IP incentive regimes, geographical mix of profits and adjustments to
prior
year tax liabilities including several one-time
items
*
Variations
in the tax rate can be expected to continue quarter to
quarter
|
EPS
|
$0.58
|
n/m
|
$1.38
|
-17%
Actual -5% CER
|
|
* Further
details of differences between Reported and Core are shown in Table
12
|
Table 3: Pipeline highlights since prior results
announcement
Event
|
Medicine
|
Indication
/ Trial
|
Event
|
Regulatory
approvals and other regulatory actions
|
Imfinzi +/- Imjudo
|
NSCLC
(1st-line) (POSEIDON)
|
Regulatory approval
(US, JP)
|
Imfinzi + Imjudo
|
Hepatocellular
carcinoma (1st-line) (HIMALAYA)
|
Regulatory approval
(JP)
|
Imfinzi
|
Biliary
tract cancer (TOPAZ-1)
|
Regulatory approval
(EU, JP)
|
Lynparza
|
mCRPC
(1st-line) (PROpel)
|
Regulatory approval
(EU)
|
Enhertu
|
HER2-positive
breast cancer (2nd-line) (DESTINY-Breast03)
|
Regulatory approval
(JP)
|
Enhertu
|
HER2-low breast
cancer (3rd-line) (DESTINY-Breast04)
|
Regulatory approval
(EU)
|
Enhertu
|
HER2-positive/HER2-low
gastric (2nd-line) (DESTINY-Gastric01,
DESTINY-Gastric02)
|
Regulatory approval
(EU)
|
Calquence
|
|
Regulatory approval
(JP)
|
|
Calquence
|
Maleate
tablet formulation
|
Regulatory approval
(EU)
|
|
Forxiga
|
|
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
|
|
Regulatory
submission (US)
|
Soliris
|
|
Regulatory
submission (CN)
|
Major
Phase III data readouts and other developments
|
Imfinzi
|
NSCLC
(1st-line) (PEARL)
|
Primary
endpoint not met
|
capivasertib
|
HR26+/HER2-negative
breast cancer (1st-line) (CAPItello-291)
|
Fast
Track Designation (US)
|
Orpathys + Tagrisso
|
NSCLC
with MET overexpression (SAVANNAH/SAFFRON)
|
Fast
Track Designation (US)
|
tozorakimab
|
Treatment/prevention
of acute respiratory failure in patients with viral lung infection
(TILIA)
|
Fast
Track Designation (US)
|
Saphnelo
|
Idiopathic
inflammatory myopathies
|
Orphan
Drug Designation (US)
|
Evusheld
|
Pre-exposure
prophylaxis of COVID-19
|
Revision of
Emergency Use Authorisation (US) - Evusheld is not currently authorised in
the US until further notice from the FDA27
|
Corporate
and business development
In
January 2023, AstraZeneca entered into a definitive agreement to
acquire CinCor Pharma, Inc. (CinCor), a US-based clinical-stage
biopharmaceutical company focused on developing novel treatments
for resistant and uncontrolled hypertension as well as chronic
kidney disease. The acquisition will bolster AstraZeneca's
cardiorenal pipeline by adding CinCor's candidate drug, baxdrostat
(CIN-107), an aldosterone synthase inhibitor for blood pressure
lowering in treatment-resistant hypertension.
AstraZeneca has
initiated a tender offer to acquire all of CinCor's outstanding
shares for a price of $26 per share in cash at closing, plus a
non-tradable contingent value right of $10 per share in cash
payable upon a specified regulatory submission of a baxdrostat
product. Combined, the upfront and maximum potential contingent
value payments represent, if achieved, a transaction value of
approximately $1.8bn. As part of the transaction, AstraZeneca will
acquire the cash and marketable securities on CinCor's balance
sheet, which totalled approximately $522m as of 30 September
2022.
In
January 2023, AstraZeneca completed the acquisition of Neogene
Therapeutics Inc. (Neogene), a global clinical-stage biotechnology
company pioneering the discovery, development and manufacturing of
next-generation T-cell receptor therapies that offer a novel cell
therapy approach for targeting cancer. AstraZeneca acquired
outstanding equity of Neogene for a total consideration of up to
$320m, on a cash and debt free basis. This includes an initial
payment of $200m on deal closing, and a further up to $120m in both
contingent milestones-based and non-contingent
consideration.
Following the
approval of Airsupra in
January 2023, AstraZeneca has notified Avillion of its intention to
commercialise Airsupra in
the US. Under the terms of the agreement with Avillion, AstraZeneca
will pay single-digit royalties and milestones based on future
sales and developments.
In
December 2022, AstraZeneca completed the sale of its R&D
facility in Waltham, Massachusetts, US, to Alexandria Real Estate
Equities, Inc, (ARE), a leading owner, operator and developer of
life science campuses. ARE will lease the site back to AstraZeneca
for a four-year term while construction is being completed on the
new AstraZeneca R&D Centre and Alexion Headquarters in Kendall
Square, Cambridge, Massachusetts, announced in April
2022.
In
January 2023, AstraZeneca completed the sale of its West Chester
site in Ohio, US, to National Resilience, Inc., a
technology-focused manufacturing company dedicated to broadening
access to complex medicines. The West Chester site will continue to
manufacture medicines for AstraZeneca.
Post
Alexion Acquisition Group Review (PAAGR)
In
conjunction with the acquisition of Alexion in 2021, AstraZeneca
initiated a comprehensive review, aimed at integrating systems,
structure and processes, optimising the global footprint and
prioritising resource allocations and investments. These activities
are expected to be substantially complete by the end of 2025, with
a number of planned activities having commenced in late 2021 and
during 2022.
During
2022, the Company has refined the scope and estimates of the
planned activities, resulting in an increase to the expected
one-time restructuring costs over the life of the programme of
$0.5bn, of which $0.3bn are non-cash costs, an increase in capital
investments of $0.1bn, and an increase to the anticipated annual
run-rate pre-tax benefits by the end of 2025 of
$0.7bn.
In
addition, initial financial estimates for the Company's planned
upgrade of its Enterprise Resource Planning IT systems have been
completed, resulting in anticipated incremental capital investments
for software assets of $0.6bn and one-time restructuring cash costs
of $0.3bn. This investment builds strongly on the PAAGR and is
expected to be substantially complete by the end of 2030, realising
significant strategic and compliance-related benefits from
transforming core enterprise-wide processes, harmonising systems
architecture and enabling future digital capabilities.
Consequently, the
total programme activities are now anticipated to incur one-time
restructuring costs of approximately $2.9bn, of which approximately
$1.9bn are cash costs and $1.0bn are non-cash costs, and capital
investments of approximately $0.9bn.
Run-rate pre-tax
benefits, before reinvestment, are now expected to be approximately
$1.9bn by the end of 2025. In line with established practice,
restructuring costs will be excluded from our Core (non-GAAP)
financial measures.
During
2022, AstraZeneca recorded restructuring charges of approximately
$0.7bn in relation to the PAAGR (2021: $1.0bn), bringing the
cumulative charges to date under this programme to $1.7bn. Of these
costs, $0.7bn are non-cash costs arising primarily from impairments
and accelerated depreciation on affected assets. As at 31 December
2022, the PAAGR has realised annual run-rate pre-tax benefits,
before reinvestment, of $0.8bn.
Sustainability
summary
In
November 2022, AstraZeneca achieved third position overall in the
2022 Access to Medicine Index.
In
January 2023, Chair Leif Johansson alongside Senior Executive Team
members Marc Dunoyer, Dave Fredrickson and Iskra Reic attended the
World Economic Forum in Davos, focusing on investing in health as
the foundation of strong and resilient societies, and the need for
collective early action to build more sustainable and equitable
healthcare systems, including through collaborations such as the
Partnership for Health System Sustainability and Resilience and the
Sustainable Markets Initiative.
Management
changes
Katarina Ageborg,
EVP Global Sustainability and Chief Compliance Officer, has
announced her retirement. Jeffrey Pott, Chief Human Resources
Officer and General Counsel, will assume responsibility as Chief
Compliance Officer in addition to his current responsibilities. Pam
Cheng, Executive Vice-President, Operations and Information
Technology, will assume responsibility for leadership of
Sustainability strategy and function in addition to her existing
responsibilities. The Board thanks Katarina for her lasting legacy,
having positioned AstraZeneca amongst the global leaders in
sustainability, backed by world-leading platforms and science-based
targets.
Conference
call
A
conference call and webcast for investors and analysts will begin
today, 9 February 2023, at 11:45 GMT. Details can be accessed via
astrazeneca.com.®
Reporting
calendar
The
Company intends to publish its results for the first quarter of
2023 on Thursday 27 April 2023.
Operating
and financial review
All
narrative on growth and results in this section is based on actual
exchange rates, and financial figures are in US$ millions ($m),
unless stated otherwise. Unless stated otherwise, the performance
shown in this announcement covers the twelve-month period to 31
December 2022 ('the year' or 'FY 2022') compared to the
twelve-month period to 31 December 2021 (FY 2021), or the
three-month period to 31 December 2022 ('the fourth quarter' or 'Q4
2022') compared to the three-month period to 31 December 2021 ('Q4
2021').
Core
financial measures, EBITDA, Net Debt, Gross Margin, Operating
Margin and CER are non-GAAP financial measures because they cannot
be derived directly from the Group's Condensed Consolidated
Financial Statements. Management believes that these non-GAAP
financial measures, when provided in combination with Reported
results, provide investors and analysts with helpful supplementary
information to understand better the financial performance and
position of the Group on a comparable basis from period to period.
These non-GAAP financial measures are not a substitute for, or
superior to, financial measures prepared in accordance with
GAAP.
Core
financial measures are adjusted to exclude certain significant
items, such as:
-
Amortisation and impairment of intangible assets, including
impairment reversals but excluding any charges relating to IT
assets
-
Charges and provisions related to restructuring programmes, which
includes charges that relate to the impact of restructuring
programmes on capitalised IT assets
-
Alexion acquisition-related items, primarily fair value adjustments
on acquired inventories and fair value impact of replacement
employee share awards
-
Other specified items, principally the imputed finance charge
relating to contingent consideration on business combinations,
legal settlements and the one-off deferred tax credit arising from
the internal reorganisation to integrate Alexion
-
The tax effects of the adjustments above are excluded from the Core
Tax charge
Details
on the nature of Core financial measures are provided on page 54 of
the Annual
Report and Form 20-F Information 2021.
Reference should be
made to the Reconciliation of Reported to Core financial measures
table included in the financial performance section in this
announcement.
Gross
Margin, previously termed Gross Profit Margin, is the percentage by
which Product Sales exceeds the Cost of sales, calculated by
dividing the difference between the two by the sales figure. The
calculation of Reported and Core Gross Margin excludes the impact
of Collaboration Revenue and any associated costs, thereby
reflecting the underlying performance of Product
Sales.
EBITDA
is defined as Reported Profit before tax after adding back Net
finance expense, results from Joint Ventures and Associates and
charges for Depreciation, Amortisation and Impairment. Reference
should be made to the Reconciliation of Reported Profit before tax
to EBITDA included in the financial performance section in this
announcement.
Net
Debt is defined as Interest-bearing loans and borrowings and Lease
liabilities, net of Cash and cash equivalents, Other investments,
and net derivative financial instruments. Reference should be made
to Note 3 'Net Debt' included in the Notes to the Condensed
Consolidated Financial Statements in this
announcement.
The
Company strongly encourages investors and analysts not to rely on
any single financial measure, but to review AstraZeneca's financial
statements, including the Notes thereto, and other available
Company reports, carefully and in their entirety.
Due to
rounding, the sum of a number of dollar values and percentages in
this announcement may not agree to totals.
Total
Revenue
Table 4: Therapy area and medicine performance
|
|
FY
2022
|
Q4
2022
|
|
|
|
|
%
Change
|
|
|
%
Change
|
Product
Sales
|
|
$m
|
%
Total
|
Actual
|
CER
|
$m
|
%
Total
|
Actual
|
CER
|
Oncology
|
|
14,631
|
33
|
13
|
19
|
3,746
|
33
|
9
|
18
|
-
Tagrisso
|
|
5,444
|
12
|
9
|
15
|
1,342
|
12
|
2
|
12
|
|
|
2,784
|
6
|
15
|
21
|
752
|
7
|
19
|
27
|
-
Lynparza
|
|
2,638
|
6
|
12
|
18
|
689
|
6
|
10
|
17
|
-
Calquence
|
|
2,057
|
5
|
66
|
69
|
588
|
5
|
49
|
53
|
-
Enhertu
|
|
79
|
-
|
>4x
|
>4x
|
28
|
-
|
>3x
|
>3x
|
-
Orpathys
|
|
33
|
-
|
>2x
|
>2x
|
(1)
|
-
|
n/m
|
n/m
|
-
Zoladex
|
|
927
|
2
|
(2)
|
6
|
210
|
2
|
(9)
|
4
|
-
Faslodex
|
|
334
|
1
|
(22)
|
(14)
|
74
|
1
|
(27)
|
(14)
|
-
Iressa
|
|
114
|
-
|
(38)
|
(34)
|
24
|
-
|
(32)
|
(24)
|
-
Arimidex
|
|
99
|
-
|
(29)
|
(24)
|
14
|
-
|
(57)
|
(50)
|
-
Casodex
|
|
78
|
-
|
(45)
|
(40)
|
16
|
-
|
(28)
|
(16)
|
-
Others
|
|
44
|
-
|
(14)
|
(6)
|
10
|
-
|
(29)
|
(18)
|
BioPharmaceuticals: CVRM 6
|
|
9,188
|
21
|
13
|
19
|
2,281
|
20
|
12
|
22
|
-
Farxiga
|
|
4,381
|
10
|
46
|
56
|
1,177
|
11
|
39
|
52
|
-
Brilinta
|
|
1,358
|
3
|
(8)
|
(4)
|
345
|
3
|
(1)
|
4
|
-
Lokelma
|
|
289
|
1
|
65
|
75
|
81
|
1
|
50
|
63
|
-
Roxadustat
|
|
197
|
-
|
13
|
18
|
49
|
-
|
65
|
87
|
-
Andexxa 6
|
|
150
|
-
|
5
|
14
|
39
|
-
|
-
|
14
|
-
Crestor
|
|
1,048
|
2
|
(4)
|
2
|
224
|
2
|
(13)
|
(2)
|
-
Seloken/Toprol-XL
|
|
862
|
2
|
(9)
|
(4)
|
157
|
1
|
(23)
|
(12)
|
-
Bydureon
|
|
280
|
1
|
(27)
|
(26)
|
73
|
1
|
(20)
|
(20)
|
-
Onglyza
|
|
257
|
1
|
(28)
|
(25)
|
52
|
-
|
(31)
|
(24)
|
-
Others
|
|
366
|
1
|
(10)
|
(7)
|
84
|
1
|
(13)
|
(6)
|
BioPharmaceuticals:
R&I
|
|
5,765
|
13
|
(4)
|
-
|
1,447
|
13
|
(9)
|
(3)
|
-
Symbicort
|
|
2,538
|
6
|
(7)
|
(2)
|
620
|
6
|
(9)
|
(2)
|
-
Fasenra
|
|
1,396
|
3
|
11
|
15
|
381
|
3
|
7
|
12
|
-
Breztri
|
|
398
|
1
|
96
|
>2x
|
116
|
1
|
59
|
68
|
-
Saphnelo
|
|
116
|
-
|
>10x
|
>10x
|
48
|
-
|
>6x
|
>6x
|
-
Tezspire
|
|
4
|
-
|
n/m
|
n/m
|
4
|
-
|
n/m
|
n/m
|
-
Pulmicort
|
|
645
|
1
|
(33)
|
(31)
|
166
|
1
|
(33)
|
(28)
|
-
Daliresp/Daxas
|
|
189
|
-
|
(17)
|
(16)
|
28
|
-
|
(52)
|
(52)
|
-
Bevespi
|
|
58
|
-
|
7
|
9
|
14
|
-
|
(5)
|
(1)
|
- Others
|
|
421
|
1
|
(29)
|
(27)
|
70
|
1
|
(53)
|
(47)
|
BioPharmaceuticals:
V&I
|
|
4,736
|
11
|
2
|
8
|
1,129
|
10
|
(51)
|
(44)
|
-
Vaxzevria
|
|
1,798
|
4
|
(54)
|
(52)
|
85
|
1
|
(95)
|
(94)
|
-
Evusheld
|
|
2,185
|
5
|
>10x
|
>10x
|
734
|
7
|
>8x
|
>9x
|
-
Synagis
|
|
578
|
1
|
41
|
59
|
194
|
2
|
(19)
|
(3)
|
-
FluMist
|
|
175
|
-
|
(31)
|
(20)
|
116
|
1
|
(35)
|
(24)
|
Rare Disease 6
|
|
7,053
|
16
|
4
|
10
|
1,816
|
16
|
4
|
10
|
- Soliris 6
|
|
3,762
|
8
|
(11)
|
(5)
|
844
|
8
|
(22)
|
(16)
|
- Ultomiris 6
|
|
1,965
|
4
|
34
|
42
|
593
|
5
|
52
|
62
|
- Strensiq 6
|
|
958
|
2
|
16
|
18
|
272
|
2
|
24
|
27
|
-
Koselugo
|
|
208
|
-
|
93
|
96
|
58
|
1
|
74
|
77
|
-
Kanuma 6
|
|
160
|
-
|
16
|
19
|
49
|
-
|
45
|
44
|
Other
Medicines
|
|
1,625
|
4
|
(5)
|
4
|
379
|
3
|
(7)
|
7
|
-
Nexium
|
|
1,285
|
3
|
(3)
|
8
|
300
|
3
|
(9)
|
7
|
- Others
|
|
340
|
1
|
(10)
|
(7)
|
79
|
1
|
(1)
|
5
|
Product
Sales
|
|
42,998
|
97
|
18
|
24
|
10,798
|
96
|
(6)
|
2
|
Collaboration
Revenue
|
|
1,353
|
3
|
54
|
56
|
409
|
4
|
(20)
|
(19)
|
Total
Revenue
|
|
44,351
|
100
|
19
|
25
|
11,207
|
100
|
(7)
|
1
|
Table
5: Collaboration Revenue
|
|
FY
2022
|
Q4
2022
|
|
|
|
|
%
Change
|
|
|
%
Change
|
|
|
$m
|
%
Total
|
Actual
|
CER
|
$m
|
%
Total
|
Actual
|
CER
|
Enhertu: alliance revenue 29
|
|
519
|
38
|
>2x
|
>2x
|
187
|
46
|
>3x
|
>3x
|
Tezspire: alliance revenue
|
|
79
|
6
|
n/m
|
n/m
|
37
|
9
|
n/m
|
n/m
|
Lynparza: regulatory
milestones
|
|
355
|
26
|
n/m
|
n/m
|
105
|
26
|
n/m
|
n/m
|
Tralokinumab: sales
milestones
|
|
110
|
8
|
n/m
|
n/m
|
-
|
-
|
-
|
-
|
Vaxzevria:
royalties
|
|
76
|
6
|
19
|
16
|
10
|
2
|
n/m
|
n/m
|
Other
royalty income
|
|
72
|
5
|
(42)
|
(41)
|
17
|
4
|
(75)
|
(74)
|
Other
Collaboration Revenue
|
|
142
|
10
|
49
|
69
|
53
|
13
|
>10x
|
>10x
|
Total
|
|
1,353
|
100
|
54
|
56
|
409
|
100
|
(20)
|
(19)
|
Table 6: Total Revenue by therapy area
|
|
FY
2022
|
Q4
2022
|
|
|
|
|
%
Change
|
|
|
%
Change
|
|
|
$m
|
%
Total
|
Actual
|
CER
|
$m
|
%
Total
|
Actual
|
CER
|
Oncology
|
|
15,539
|
35
|
15
|
20
|
4,046
|
36
|
4
|
12
|
BioPharmaceuticals
6
|
|
20,010
|
45
|
5
|
11
|
4,932
|
44
|
(17)
|
(9)
|
- CVRM6
|
|
9,211
|
21
|
13
|
19
|
2,284
|
20
|
12
|
22
|
- R&I
|
|
5,963
|
13
|
(1)
|
3
|
1,485
|
13
|
(7)
|
(1)
|
- V&I
|
|
4,836
|
11
|
1
|
8
|
1,163
|
10
|
(50)
|
(43)
|
Rare
Disease6
|
|
7,053
|
16
|
4
|
10
|
1,816
|
16
|
4
|
10
|
Other
Medicines
|
|
1,748
|
4
|
(4)
|
5
|
412
|
4
|
(2)
|
12
|
Total
|
|
44,351
|
100
|
19
|
25
|
11,207
|
100
|
(7)
|
1
|
Table 7: Total Revenue by region
|
|
FY
2022
|
Q4
2022
|
|
|
|
|
%
Change
|
|
|
%
Change
|
|
|
$m
|
%
Total
|
Actual
|
CER
|
$m
|
%
Total
|
Actual
|
CER
|
Emerging
Markets
|
|
11,745
|
26
|
(4)
|
1
|
2,733
|
24
|
(25)
|
(18)
|
- China
|
|
5,792
|
13
|
(4)
|
-
|
1,194
|
11
|
(9)
|
3
|
- Ex-China
|
|
5,953
|
13
|
(5)
|
1
|
1,538
|
14
|
(35)
|
(29)
|
US
|
|
17,920
|
40
|
47
|
47
|
4,788
|
43
|
22
|
22
|
Europe
|
|
8,738
|
20
|
9
|
21
|
2,308
|
21
|
(20)
|
(8)
|
Established
RoW
|
|
5,948
|
13
|
22
|
40
|
1,378
|
12
|
(11)
|
8
|
Total
|
|
44,351
|
100
|
19
|
25
|
11,207
|
100
|
(7)
|
1
|
Table 8: Total Revenue by region - excluding Vaxzevria
|
|
FY
2022
|
Q4
2022
|
|
|
|
|
%
Change
|
|
|
%
Change
|
|
|
$m
|
%
Total
|
Actual
|
CER
|
$m
|
%
Total
|
Actual
|
CER
|
Emerging
Markets
|
|
10,940
|
25
|
10
|
16
|
2,678
|
24
|
7
|
18
|
- China
|
|
5,746
|
13
|
(4)
|
(1)
|
1,194
|
11
|
(8)
|
4
|
- Ex-China
|
|
5,195
|
12
|
31
|
41
|
1,484
|
13
|
24
|
33
|
US
|
|
17,840
|
40
|
47
|
47
|
4,788
|
43
|
24
|
24
|
Europe
|
|
8,372
|
19
|
19
|
33
|
2,268
|
20
|
(12)
|
1
|
Established
RoW
|
|
5,323
|
12
|
24
|
43
|
1,378
|
12
|
4
|
27
|
Total
|
|
42,476
|
96
|
27
|
34
|
11,112
|
99
|
8
|
17
|
Oncology
Oncology Total
Revenue increased by 15% (20% at CER) in FY 2022 to $15,539m and
represented 35% of overall Total Revenue (FY 2021: 36%). This
included Lynparza
Collaboration Revenue of $355m (FY 2021: $400m) and
Enhertu Collaboration
Revenue of $523m (FY 2021: $197m). Product Sales increased by 13%
(19% at CER) in FY 2022 to $14,631m, reflecting new launches and
increased patient access for Tagrisso, Imfinzi, Lynparza and Calquence partially offset by declines
in some older medicines.
Tagrisso
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
FY 2022
$m
|
|
5,444
|
|
1,567
|
2,007
|
1,023
|
847
|
Actual
change
|
|
9%
|
|
17%
|
13%
|
4%
|
(7%)
|
CER
change
|
|
15%
|
|
22%
|
13%
|
17%
|
8%
|
Region
|
|
Drivers and
commentary
|
Worldwide
|
|
* Increased use of Tagrisso in adjuvant and 1st-line setting and expansion of
reimbursed access, partially offset by COVID-19
headwinds
|
Emerging
Markets
|
|
* Rising demand from increased patient access in
China continues to offset the impact of the March 2021
NRDL30 price reduction
* The
fourth quarter saw some impact from year-end ordering dynamics in
China
|
US
|
|
* Improving
use in 1st-line with longer duration of treatment and increasing
adjuvant penetration, partially offset by lower 2nd-line
use
|
Europe
|
|
* Greater use in 1st-line and adjuvant settings;
established 1st-line standard of care in EU531, partially offset by lower 2nd-line
use
|
Established
RoW
|
|
* Increased
use in 1st-line setting and launch progress in adjuvant, including
Japan
|
Imfinzi
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
FY 2022
$m
|
|
2,784
|
|
287
|
1,552
|
544
|
401
|
Actual
change
|
|
15%
|
|
4%
|
25%
|
12%
|
(1%)
|
CER
change
|
|
21%
|
|
7%
|
25%
|
26%
|
15%
|
Region
|
|
Drivers and
commentary
|
Worldwide
|
|
* The Imfinzi revenue line includes sales of Imjudo, which commenced in Q4 2022 following approvals in
the US for patients with unresectable liver cancer (HIMALAYA) and
Stage IV NSCLC (POSEIDON)
* Increased use of Imfinzi in
GI, liver and lung cancer
* Continued
recovery in diagnosis and treatment rates following the COVID-19
pandemic across all regions, excluding China
|
Emerging
Markets
|
|
* Growth
in ex-China driven by improved diagnosis and treatment rates
following the COVID-19 pandemic
|
US
|
|
* New patient starts across Stage III NSCLC and
ES-SCLC32
* Strong launch in BTC33 following September 2022 FDA approval (TOPAZ-1),
and growing penetration of Imfinzi + Imjudo in metastatic NSCLC and HCC
|
Europe
|
|
* Increased
market penetration in ES-SCLC, growth in the number of reimbursed
markets, and ongoing recovery in rates of diagnosis and
treatment
|
Established
RoW
|
|
* New
reimbursements
|
Lynparza
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
FY 2022
$m
|
|
2,993
|
|
488
|
1,226
|
1,010
|
269
|
Actual
change
|
|
9%
|
|
27%
|
13%
|
(1%)
|
4%
|
CER
change
|
|
14%
|
|
31%
|
13%
|
7%
|
20%
|
Product
Sales
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
FY 2022
$m
|
|
2,638
|
|
488
|
1,226
|
655
|
269
|
Actual
change
|
|
12%
|
|
27%
|
13%
|
6%
|
4%
|
CER
change
|
|
18%
|
|
31%
|
13%
|
19%
|
20%
|
Region
|
|
Drivers and
commentary
|
Worldwide
|
|
* Lynparza remains the leading medicine in the
PARP34 inhibitor class globally across four tumour types,
as measured by total prescription volume
* Total Revenue includes $355m in regulatory
milestones received from MSD and recognised in Europe, following
approval in the US and EU for the adjuvant treatment of patients
with gBRCAm35 breast cancer (OlympiA), and approval in the EU
for the treatment of mCRPC (PROpel)
|
Emerging
Markets
|
|
* Increased patient access following admission to
China's NRDL as a 1st-line maintenance treatment for
BRCAm36 ovarian cancer patients, with effect from March
2021; launches in other markets
|
US
|
|
* US
launch in early breast cancer following March 2022 FDA approval
(OlympiA)
* Increased
use in breast, ovarian and prostate cancers
|
Europe
|
|
*
Increasing HRD testing rates and use in 1st-line
HRD-positive ovarian cancer, increased Lynparza uptake in BRCAm mCRPC37 and gBRCAm HER2-negative advanced breast cancer
and the EU launch in gBRCAm early breast cancer following
EMA38 approval in August (OlympiA)
|
Established
RoW
|
|
*
New
launches and high levels of HRD testing in Japan
|
Enhertu
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
FY 2022
$m
|
|
602
|
|
80
|
405
|
110
|
7
|
Actual
change
|
|
>2x
|
|
>6x
|
>2x
|
>3x
|
>10x
|
CER
change
|
|
>2x
|
|
>6x
|
>2x
|
>3x
|
>10x
|
Region
|
|
Drivers and
commentary
|
Worldwide
|
|
* Excluding Japan, Enhertu global in-market sales recorded by Daiichi Sankyo
Company Limited (Daiichi Sankyo) and AstraZeneca, amounted to
$1,173m in the year (FY 2021: $426m)
* AstraZeneca's
Total Revenue of $602m includes $523m of Collaboration Revenue from
its share of gross profit in territories where Daiichi Sankyo
records product sales and royalties on sales in Japan
|
Emerging
Markets
|
|
* Strong
uptake in early launch markets
|
US
|
|
* US
in-market sales, recorded by Daiichi Sankyo, amounted to $850m in
the year (FY 2021: $357m)
* Now
standard of care in 2nd-line HER2-positive metastatic breast cancer
following May 2022 FDA approval (DESTINY-Breast03) and after first
chemotherapy in HER2-low metastatic breast cancer following August
2022 FDA approval (DESTINY-Breast04)
|
Europe
|
|
* Growth
in 3rd-line+ HER2-positive metastatic breast and launch in 2nd-line
HER2-positive metastatic breast cancer after EMA approval in July
2022 (DESTINY-Breast03)
|
Established
RoW
|
|
* In
Japan, AstraZeneca receives a mid-single-digit percentage royalty
on sales made by Daiichi Sankyo
|
Calquence
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
FY 2022
$m
|
|
2,057
|
|
45
|
1,657
|
286
|
69
|
Actual
change
|
|
66%
|
|
>2x
|
52%
|
>2x
|
>3x
|
CER
change
|
|
69%
|
|
>2x
|
52%
|
>2x
|
>4x
|
Region
|
|
Drivers and
commentary
|
Worldwide
|
|
* Increased penetration globally; leading
BTKi39 in key markets
|
US
|
|
* Increased
share of new patient starts
* Inventory
build in Q3 following maleate tablet formulation launch in August;
Q4 observed partial inventory work down
|
Europe
|
|
* Increased
share of new patient starts
|
Orpathys
Total
Revenue of $33m (FY 2021: $16m), growth was driven by the 2021
launch in China, where it is approved for patients with lung cancer
and MET gene alterations. Orpathys has been included in the
updated NRDL in China for the treatment of patients with NSCLC with
MET exon 14 skipping alterations. The updated NRDL will take effect
from 1 March 2023.
Other
Oncology medicines
Total
Revenue
|
|
$m
|
Actual
|
CER
|
|
Zoladex
|
|
957
|
(1%)
|
7%
|
Increased
use in ex-China Emerging Markets, offsetting a price cut in
Japan
|
Faslodex
|
|
334
|
(22%)
|
(14%)
|
Generic
competition
|
Iressa
|
|
114
|
(38%)
|
(34%)
|
Continued share loss to next-generation
TKIs40
|
Arimidex
|
|
99
|
(29%)
|
(24%)
|
|
Casodex
|
|
78
|
(45%)
|
(40%)
|
Ongoing
impact from VBP implementation
|
Other
Oncology
|
|
44
|
(14%)
|
(6%)
|
|
BioPharmaceuticals
Including V&I
medicines, BioPharmaceuticals Total Revenue increased by 5% (11% at
CER) in FY 2022 to $20,010m, representing 45% of overall Total
Revenue (FY 2021: 51%). Growth was driven by strong Farxiga performance, Evusheld revenues offsetting the
decline in Vaxzevria, and
growth from newer R&I medicines offsetting decreases in
Pulmicort and other older
R&I medicines.
BioPharmaceuticals
- CVRM
CVRM
Total Revenue increased by 13% (19% at CER) to $9,211m in FY 2022,
driven by a strong Farxiga
performance, and represented 21% of overall Total Revenue (FY 2021:
22%).
Farxiga
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
FY 2022
$m
|
|
4,386
|
|
1,665
|
1,071
|
1,297
|
353
|
Actual
change
|
|
46%
|
|
39%
|
46%
|
60%
|
31%
|
CER
change
|
|
56%
|
|
47%
|
46%
|
81%
|
48%
|
Region
|
|
Drivers and
commentary
|
Worldwide
|
|
* Farxiga volume is growing faster than the overall
SGLT241 market in all major regions
* Additional
benefit from continued growth in the overall SGLT2 inhibitor
class
* Further HF42 and CKD launches and supportive updates to
treatment guidelines including from ESC43 and AHA44/ACC45/HFSA46. HF and CKD indications now launched in >100
markets
|
Emerging
Markets
|
|
* Growth
despite generic competition in some markets. Solid growth in
ex-China Emerging Markets, particularly Latin America
|
US
|
|
* Regulatory approval for HFrEF47 in May 2020, treatment of CKD in May 2021. Both
approvals included patients with and without T2D48
* Farxiga continued to gain in-class brand share, driven by
HF and CKD launches
|
Europe
|
|
* The
beneficial addition of cardiovascular outcomes trial data to the
label, the HFrEF regulatory approval in November 2020, and CKD
regulatory approval in August 2021
* Forxiga continued gaining in-class market share in the
period
|
Established
RoW
|
|
* In
Japan, AstraZeneca sells to collaborator Ono Pharmaceutical Co.,
Ltd, which records in-market sales. Continued volume growth driven
by HF and CKD launches
|
Brilinta
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
FY 2022
$m
|
|
1,358
|
|
286
|
744
|
282
|
46
|
Actual
change
|
|
(8%)
|
|
(13%)
|
1%
|
(18%)
|
(27%)
|
CER
change
|
|
(4%)
|
|
(10%)
|
1%
|
(8%)
|
(22%)
|
Region
|
|
Drivers and
commentary
|
Emerging
Markets
|
|
* Adverse impact from Brilinta's inclusion in China's VBP
programme
* Growth
in ex-China Emerging Markets
|
US,
Europe
|
|
* Q4
US sales growth favourably impacted by a one-time adjustment. Some
market recovery of oral antiplatelet therapies following the
pandemic
|
Lokelma
Total
Revenue increased 65% (75% at CER) to $289m in FY 2022, driven by
Lokelma extending its
branded market share lead in the US and also achieving total
potassium binder market share leadership in the period. Continued
progress in Europe from recent launches across the region where
Lokelma extended its market
share in the period. In China, Lokelma was admitted to the NRDL with
effect from 1 January 2022 and is now the leading potassium binder
in the country.
Roxadustat
Total
Revenue increased 12% (17% at CER) to $202m, with roxadustat
benefitting from increased volumes in China following NRDL price
cuts.
Andexxa
On a
pro forma basis, Andexxa
Total Revenue increased 12% (21% at CER) to $160m.
Other
CVRM medicines
Total
Revenue
|
|
$m
|
Actual
|
CER
|
|
Crestor
|
|
1,050
|
(4%)
|
2%
|
* Sales
growth at CER driven by Emerging Markets, offset by declines in the
US and Europe
|
Seloken
|
|
863
|
(9%)
|
(4%)
|
* Emerging Markets sales impacted by China VBP
implementation of Betaloc49 oral in H2 2021. Betaloc ZOK VBP was implemented in Q4 2022
|
Onglyza
|
|
257
|
(28%)
|
(25%)
|
* Ongoing
impact from VBP implementation
|
Bydureon
|
|
280
|
(27%)
|
(26%)
|
* Continued
competitive pressures
|
Other
CVRM
|
|
366
|
(10%)
|
(7%)
|
|
BioPharmaceuticals
- R&I
Total
Revenue of $5,963m from R&I medicines in FY 2022 decreased 1%
(increased 3% at CER) and represented 13% of overall Total Revenue
(FY 2021: 16%). This reflected growth in recently launched brands,
including Fasenra,
Tezspire, Breztri and Saphnelo, offset by the erosion of
Pulmicort revenue following
its inclusion in VBP in China in Q4 2021, and a smaller decline in
Symbicort
revenue.
Symbicort
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
FY 2022
$m
|
|
2,538
|
|
608
|
973
|
582
|
375
|
Actual
change
|
|
(7%)
|
|
-
|
(9%)
|
(13%)
|
(2%)
|
CER
change
|
|
(2%)
|
|
5%
|
(9%)
|
(3%)
|
5%
|
Region
|
|
Drivers and
commentary
|
Worldwide
|
|
* Symbicort remains the global market leader within a stable
ICS50/LABA51 class
|
Emerging
Markets
|
|
*
Growth
driven primarily by Latin America, Middle East and Asia Area,
offset by decrease in China due to COVID-19
restrictions
|
US
|
|
* Strong
market share performance, consolidating leadership in a declining
ICS/LABA market, offset by pricing pressure
|
Europe
|
|
* Resilient
market share in growing ICS/LABA market, offset by pricing
pressure
|
Established
RoW
|
|
* Growth
in some countries driven by share gains and a continued recovery in
the ICS/LABA market. That growth was offset by generic erosion in
other countries
|
Fasenra
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
FY 2022
$m
|
|
1,396
|
|
43
|
906
|
305
|
142
|
Actual
change
|
|
11%
|
|
>2x
|
15%
|
7%
|
(12%)
|
CER
change
|
|
15%
|
|
>2x
|
15%
|
20%
|
(1%)
|
Region
|
|
Drivers and
commentary
|
Worldwide
|
|
* Fasenra continues to be market leader in severe
eosinophilic asthma in major markets, and leading in the
IL-552 class
|
Emerging
Markets
|
|
* Strong
volume growth driven by launch acceleration across key
markets
|
US
|
|
* Maintained
a strong total patient share in the severe asthma
market
|
Europe
|
|
* Sustained
growth by expanding leadership in severe eosinophilic
asthma
|
Established
RoW
|
|
* Maintained market leadership in Japan, partially
offset by price adjustments and impact in the dynamic
market53 related to the rise in COVID-19
cases
|
Breztri
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
FY 2022
$m
|
|
398
|
|
92
|
239
|
33
|
34
|
Actual
change
|
|
96%
|
|
68%
|
>2x
|
>4x
|
32%
|
CER
change
|
|
>2x
|
|
75%
|
>2x
|
>5x
|
56%
|
Region
|
|
Drivers and
commentary
|
Worldwide
|
|
* Breztri continued to gain market share within the growing
FDC54 triple class across major
markets
|
Emerging
Markets
|
|
* In China, the FDC triple class continued to
penetrate the inhaled maintenance market, with growth impacted by
COVID-19. Breztri continued its market share leadership within the
fixed-dose triple class
|
US
|
|
* Consistent new-to-brand55 and total market share growth within the FDC
triple class
|
Europe
|
|
* Sustained
growth across markets as new launches continue to
progress
|
Established
RoW
|
|
* Strong
new-to-brand market share performance in Japan, with the dynamic
market impacted by access restrictions related to the rise in
COVID-19 cases
|
Saphnelo
Total
Revenue of $116m in the year (FY 2021: $8m) was driven by demand
acceleration in the US, where Saphnelo achieved new-to-brand
leadership in the i.v.56 segment for
SLE57 and received a
permanent J-code facilitating reimbursement. Growth was further
supported by launches in Germany and Japan during the
year.
Tezspire
Tezspire is approved in the US, EU and
Japan (as well as other countries) for the treatment of severe
asthma without biomarker or phenotypic limitation. Collaboration
Revenue of $82m in the year (FY 2021: $nil) reflected the strong
early launch performance in the US. In Europe and Established RoW,
AstraZeneca recorded $4m revenue ($2m in each region).
Amgen
records sales in the US and AstraZeneca records its share of gross
profits in the US as Collaboration Revenue. Total ex-US product
sales are recorded as AstraZeneca revenue ($4m in 2022). Global
in-market sales of Tezspire
were $174m in 2022.
Other
R&I medicines
Total
Revenue
|
|
$m
|
Actual
|
CER
|
|
Pulmicort
|
|
645
|
(33%)
|
(31%)
|
* Emerging
Markets revenue decreased 40% (39% at CER) to $462m, impacted by
VBP implementation in China, lower rates of hospitalisations and
limited access to nebulisation centres in China due to COVID-19
lockdowns
* Revenues
in Ex-China Emerging Markets grew following recovery of
nebulisation demand
|
Daliresp/Daxas
|
|
189
|
(17%)
|
(16%)
|
* Impacted
by uptake of multiple generics following loss of exclusivity in the
US
* Total
Revenue in the fourth quarter decreased by 52%
|
Bevespi
|
|
58
|
7%
|
9%
|
|
Other
R&I
|
|
540
|
(11%)
|
(9%)
|
* Collaboration
Revenue of $119m (FY 2021: $15m), including $110m of milestones
relating to tralokinumab (FY 2021: $nil)
*Product
Sales of $421m decreased 29% (27% at CER)
|
BioPharmaceuticals
- V&I
Total
Revenue from V&I medicines was broadly flat at $4,836m (FY
2021: $4,779m) and represented 11% of overall Total Revenue (FY
2021: 13%).
Vaxzevria
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
FY 2022
$m
|
|
1,875
|
|
805
|
79
|
365
|
625
|
Actual
change
|
|
(53%)
|
|
(65%)
|
24%
|
(65%)
|
8%
|
CER
change
|
|
(51%)
|
|
(65%)
|
24%
|
(61%)
|
17%
|
Region
|
|
Drivers and
commentary
|
Worldwide
|
|
*
Revenue in the fourth quarter decreased by 95%
(94% at CER) due to the conclusion of Vaxzevria contracts
|
Emerging
Markets
|
|
*
$76m
of Collaboration Revenue from sub-licensees in FY 2022, including
$46m in Q1 2022 from a Chinese sub-licensee producing vaccines for
export
* Revenue
in the fourth quarter decreased by 95%
|
US
|
|
* Purchases
by the US Government for donation overseas in Q1 2022
* No
revenue was recorded after Q1 2022
|
Europe
|
|
* Revenue
in the fourth quarter decreased by 87% (84% at CER) vs Q4
2021
|
Established
RoW
|
|
* No
revenue was recorded for Established RoW in the fourth
quarter
|
Evusheld
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
FY 2022
$m
|
|
2,184
|
|
413
|
1,067
|
298
|
407
|
Actual
change
|
|
>10x
|
|
>6x
|
n/m
|
>4x
|
n/m
|
CER
change
|
|
>10x
|
|
>6x
|
n/m
|
>5x
|
n/m
|
Region
|
|
Drivers and
commentary
|
US
|
|
* AstraZeneca
fulfilled the US Government's order for 1.7 million units during
the year
|
Emerging
Markets
|
|
* Government
contracts in Central and Eastern Europe, Latin America and South
East Asia
|
Europe
|
|
* Approved
in the EU for prevention of COVID-19 in March 2022 and treatment of
COVID-19 in September 2022
|
Established
RoW
|
|
* Approved
in Japan for prevention and treatment of COVID-19 in August
2022
|
Other
V&I medicines
Total
Revenue
|
|
$m
|
Actual
|
CER
|
|
Synagis
|
|
578
|
41%
|
59%
|
* Ex-US
rights reverted to AstraZeneca after 30 June 2021, from AbbVie
Inc.
* In Q4 2022, Synagis sales decreased by 19% (3% CER), reflecting the
early start to the RSV season in the prior year
period
|
FluMist
|
|
175
|
(31%)
|
(20%)
|
* Late
start to the influenza season in Europe
|
Rare
Disease
On a
pro forma basis, Total Revenue from Rare Disease medicines
increased by 4% (10% at CER) in FY 2022 to $7,053m, representing
16% of overall Total Revenue.
Performance was
driven by the durability of the C558 franchise,
Soliris and Ultomiris growth in neurology
indications, Ultomiris
gMG launch, and
expansion into new markets.
Strensiq and Koselugo performances were driven by
continued patient demand and geographic expansion.
These
tables show pro forma growth rates for each of the medicines
acquired with Alexion, calculated by comparing FY 2022 revenues
with the medicine's revenues from 1 January 2021 to 31 December
2021.
Soliris
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
FY 2022
$m
|
|
3,762
|
|
301
|
2,180
|
805
|
476
|
Actual
change6
|
|
(11%)
|
|
(29%)
|
(7%)
|
(21%)
|
11%
|
CER
change6
|
|
(5%)
|
|
(10%)
|
(7%)
|
(12%)
|
24%
|
Region
|
|
Drivers and
commentary
|
US
|
|
Performance impacted by successful conversion
to Ultomiris in PNH59, aHUS60 and gMG61, partially offset by Soliris growth in NMOSD
|
Ex-US
|
|
Decline driven by successful conversion to
Ultomiris, slightly offset by growth in NMOSD and expansion
in new markets
|
Ultomiris
Total
Revenue
|
|
Worldwide
|
|
Emerging
Markets
|
US
|
Europe
|
Established
RoW
|
FY 2022
$m
|
|
1,965
|
|
38
|
1,136
|
481
|
310
|
Actual
change6
|
|
34%
|
|
>2x
|
35%
|
49%
|
6%
|
CER
change6
|
|
42%
|
|
>2x
|
35%
|
68%
|
26%
|
Region
|
|
Drivers and
commentary
|
Worldwide
|
|
* Performance
driven by gMG launch in the US and expansion into new
markets
* Quarter-on-quarter variability in revenue growth
can be expected due to Ultomiris every eight-week dosing schedule and lower average
annual treatment cost per patient compared to Soliris
|
US
|
|
* Performance driven by successful conversion
from Soliris across PNH, aHUS and gMG
|
Europe
|
|
* Growth
driven by strong demand generation following new launch
markets
|
Established
RoW
|
|
* Rapid
conversion in new launch markets, strong growth in Japan following
gMG launch
|
Other
Rare Disease medicines
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)
Total
Revenue
|
|
$m
|
Actual
|
CER
|
Commentary
|
Nexium
|
|
1,367
|
(4%)
|
7%
|
* Nexium (oral) was implemented in China's VBP programme in
February 2021 and Nexium i.v. was implemented in October
2021
* Generic competition in Japan increased in the fourth
quarter
|
Others
|
|
381
|
(4%)
|
(1%)
|
|
Financial
performance
Table 9: Reported Profit and Loss
|
|
FY
2022
|
FY
2021
|
%
Change
|
Q4
2022
|
Q4
2021
|
%
Change
|
|
|
|
$m
|
$m
|
Actual
|
CER
|
$m
|
$m
|
Actual
|
CER
|
Total
Revenue
|
|
44,351
|
37,417
|
19
|
25
|
11,207
|
12,011
|
(7)
|
1
|
- Product Sales
|
|
42,998
|
36,541
|
18
|
24
|
10,798
|
11,498
|
(6)
|
2
|
- Collaboration Revenue
|
|
1,353
|
876
|
54
|
56
|
409
|
513
|
(20)
|
(19)
|
Cost of
sales
|
|
(12,391)
|
(12,437)
|
-
|
4
|
(2,900)
|
(4,625)
|
(37)
|
(35)
|
Gross
profit
|
|
31,960
|
24,980
|
28
|
35
|
8,307
|
7,386
|
12
|
24
|
Gross Margin
|
|
71.2%
|
66.0%
|
+5pp
|
+5pp
|
73.1%
|
59.8%
|
+13pp
|
+15pp
|
Distribution
expense
|
|
(536)
|
(446)
|
20
|
29
|
(156)
|
(124)
|
26
|
38
|
% Total Revenue
|
|
1.2%
|
1.2%
|
-
|
-
|
1.4%
|
1.0%
|
-
|
-
|
R&D
expense
|
|
(9,762)
|
(9,736)
|
-
|
5
|
(2,625)
|
(2,584)
|
2
|
9
|
% Total Revenue
|
|
22.0%
|
26.0%
|
+4pp
|
+4pp
|
23.4%
|
21.5%
|
-2pp
|
-2pp
|
SG&A
expense
|
|
(18,419)
|
(15,234)
|
21
|
26
|
(4,621)
|
(5,117)
|
(10)
|
(3)
|
% Total Revenue
|
|
41.5%
|
40.7%
|
-1pp
|
-
|
41.2%
|
42.6%
|
+1pp
|
+2pp
|
|
|
514
|
1,492
|
(66)
|
(65)
|
189
|
147
|
29
|
33
|
% Total Revenue
|
|
1.2%
|
4.0%
|
-3pp
|
-3pp
|
1.7%
|
1.2%
|
-
|
-
|
Operating
profit/(loss)
|
|
3,757
|
1,056
|
>3x
|
>3x
|
1,094
|
(292)
|
n/m
|
n/m
|
Operating Margin
|
|
8.5%
|
2.8%
|
6
|
7
|
9.8%
|
-2.4%
|
+12pp
|
+14pp
|
Net
finance expense
|
|
(1,251)
|
(1,257)
|
(1)
|
5
|
(315)
|
(335)
|
(6)
|
-
|
Joint
ventures and associates
|
|
(5)
|
(64)
|
(92)
|
(91)
|
(1)
|
(9)
|
(89)
|
(89)
|
Profit/(loss)
before tax
|
|
2,501
|
(265)
|
n/m
|
n/m
|
778
|
(636)
|
n/m
|
n/m
|
Taxation
|
|
792
|
380
|
>2x
|
>3x
|
124
|
290
|
(57)
|
21
|
Tax
rate
|
|
-32%
|
143%
|
|
|
-16%
|
46%
|
|
|
Profit/(loss)
after tax
|
|
3,293
|
115
|
n/m
|
n/m
|
902
|
(346)
|
n/m
|
n/m
|
Earnings
per share
|
|
$ 2.12
|
$0.08
|
n/m
|
n/m
|
$0.58
|
$(0.22)
|
n/m
|
n/m
|
Table 10: Reconciliation of Reported Profit before tax to
EBITDA
|
|
FY
2022
|
FY
2021
|
%
Change
|
Q4
2022
|
Q4
2021
|
%
Change
|
|
|
$m
|
$m
|
Actual
|
CER
|
$m
|
$m
|
Actual
|
CER
|
Reported
Profit/(loss) before tax
|
|
2,501
|
(265)
|
n/m
|
n/m
|
778
|
(636)
|
n/m
|
n/m
|
Net
finance expense
|
|
1,251
|
1,257
|
(1)
|
5
|
315
|
335
|
(6)
|
-
|
Joint
ventures and associates
|
|
5
|
64
|
(92)
|
(91)
|
1
|
9
|
(89)
|
(89)
|
Depreciation,
amortisation and impairment
|
|
5,480
|
6,530
|
(16)
|
(12)
|
1,480
|
2,192
|
(32)
|
(28)
|
EBITDA
|
|
9,237
|
7,586
|
22
|
33
|
2,574
|
1,900
|
36
|
56
|
EBITDA
of $9,237m in the year (FY 2021: $7,586m) has been negatively
impacted by the $3,484m (FY 2021: $2,198m) unwind of inventory
fair value uplift recognised on the acquisition of Alexion. EBITDA
of $2,574m in the quarter (Q4 2021: $1,900m) has been negatively
impacted by the $309m (Q4 2021: $1,154m) unwind of inventory fair
value uplift recognised on the acquisition of Alexion. The unwind
of the remaining $114m inventory fair value uplift is expected to
depress EBITDA in 2023.
Table 11: Reconciliation of Reported to Core financial measures: FY
2022
FY
2022
|
|
Reported
|
Restructuring
|
Intangible
Asset Amortisation & Impairments
|
Acquisition
of Alexion
|
Other
|
Core
|
Core
%
Change
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
Gross
profit
|
|
31,960
|
266
|
32
|
3,506
|
(1)
|
35,763
|
28
|
35
|
Gross Margin
|
|
71.2%
|
|
|
|
|
80.0%
|
+6pp
|
+6pp
|
Distribution
expense
|
|
(536)
|
2
|
-
|
-
|
-
|
(534)
|
20
|
28
|
R&D
expense
|
|
(9,762)
|
111
|
124
|
27
|
-
|
(9,500)
|
19
|
24
|
SG&A
expense
|
|
(18,419)
|
405
|
4,165
|
38
|
|
(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)
|
|
(2,058)
|
38
|
46
|
EPS
|
|
$2.12
|
$0.36
|
$2.27
|
$1.77
|
$0.14
|
$6.66
|
26
|
33
|
Table 12: Reconciliation of Reported to Core financial measures: Q4
2022
Q4
2022
|
|
Reported
|
Restructuring
|
Intangible
Asset Amortisation & Impairments
|
Acquisition
of Alexion
|
Other
|
Core
|
Core
%
Change
|
|
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
Actual
|
CER
|
Gross
profit
|
|
8,307
|
110
|
8
|
320
|
-
|
8,745
|
(3)
|
6
|
Gross Margin
|
|
73.1%
|
|
|
|
|
77.2%
|
+3pp
|
+4pp
|
Distribution
Expense
|
|
(156)
|
-
|
-
|
-
|
-
|
(156)
|
27
|
39
|
R&D
expense
|
|
(2,625)
|
54
|
41
|
4
|
-
|
(2,526)
|
5
|
12
|
SG&A
expense
|
|
(4,621)
|
142
|
1,105
|
3
|
(212)
|
(3,583)
|
6
|
15
|
Total
operating expense
|
|
(7,402)
|
196
|
1,146
|
7
|
(212)
|
(6,265)
|
6
|
14
|
Other
operating income & expense
|
|
189
|
(59)
|
-
|
-
|
-
|
130
|
(11)
|
(7)
|
Operating
profit
|
|
1,094
|
247
|
1,154
|
327
|
(212)
|
2,610
|
(21)
|
(10)
|
Operating Margin
|
|
9.8%
|
|
|
|
|
23.3%
|
-4pp
|
-3pp
|
Net
finance expense
|
|
(315)
|
-
|
-
|
-
|
70
|
(245)
|
5
|
9
|
Taxation
|
|
124
|
(72)
|
(223)
|
(84)
|
29
|
(226)
|
(55)
|
(44)
|
EPS
|
|
$0.58
|
$0.11
|
$0.60
|
$0.16
|
($0.07)
|
$1.38
|
(17)
|
(5)
|
Profit
and Loss drivers
Gross
profit
-
The Gross Margin (Reported and Core) in the year was impacted
by:
-
Positive mix effects: the increased contribution from Rare Disease
and Oncology medicines had a positive impact on the Gross
Margin
-
Negative mix effects: sales of Vaxzevria and medicines with
profit-sharing arrangements (primarily Lynparza) had a dilutive impact on the
Gross Margin
-
Inventory write downs
and provisions for excess manufacturing reservation fees relating
to Evusheld
-
Pricing pressure relating to procurement programmes in China
-
Reported Gross Profit was also impacted by the unwind of the fair
value adjustment to Alexion inventories at the date of acquisition.
The fair value uplift is expected to unwind through Reported Cost
of sales in line with associated revenues, and in FY 2022, the
impact of the fair value uplift unwind on Cost of sales was $3,484m
(FY 2021: $2,198m)
-
Currency fluctuations had a small positive impact on Gross Margin
in the year. Currency fluctuations may have a positive or negative
impact on Gross Margin in future quarters
-
Variations in Gross Margin performance between periods can be
expected to continue
R&D
expense
-
The increase in Reported and Core R&D expense was impacted
by:
-
The acquisition of Alexion in July 2021
-
Recent positive data read outs for several high priority medicines
that ungated late-stage Oncology trials
-
The advancement of a number of mid-stage clinical development
programmes in BioPharmaceuticals
-
Investment in platforms, new technology and capabilities to enhance
R&D productivity
SG&A
expense
-
The increase in Reported and Core SG&A expense was driven
by:
-
The acquisition of Alexion in July 2021
-
Market development activities for launches
-
Reported SG&A expense was also impacted by amortisation of
intangible assets related to the Alexion acquisition and other
acquisitions and collaborations, and a $775m legal settlement with
Chugai
Other
operating income
-
Reported Other operating income of $514m consisted primarily of
disposal proceeds on small divestments, including the divestment of
rights to Plendil in the second quarter, disposal proceeds on sale
of tangible assets, and royalties
-
In FY 2021, Reported Other operating income of $1,492m included
$776m of divestment gains from AstraZeneca's share of Viela Bio,
Inc. and $317m from the divestment of commercial rights to
Crestor
in over 30 countries in Europe
(excluding UK and Spain)
Net
finance expense
-
The
change in Reported and Core Net finance expense in the year was
primarily driven by financing costs on debt for the Alexion
transaction. Reported Net finance expense was also impacted by a
reduction in the discount unwind on acquisition-related
liabilities, including the Diabetes Alliance
Taxation
-
The effective Reported Tax Rate for the year was -32% (FY 2021:
143%) and the Core Tax rate was 17% (FY 2021: 17%)
-
The Reported Tax Rate for the year included a one-time favourable
net adjustment of $876m to deferred taxes arising from an internal
reorganisation to integrate the Alexion organisation which took
place in the third quarter. The internal legal entity
reorganisation did not result in any corporate income tax becoming
payable in the year, however it did result in a one-off deferred
tax adjustment of $876m to the income statement, and a further $49m
credit associated with the reorganisation is included in Other
Comprehensive Income. Following the reorganisation, it was
necessary to re-measure certain deferred tax balances to reflect
the tax rates applicable on their reversal as under the revised
structure there is a change in the income flows to the relevant
territories
-
The Reported Tax rate of -32% was lower than the Core Tax Rate of
17% primarily due to the impact of the aforementioned internal
restructuring. The 2022 Reported and Core Tax rates also benefited
from IP incentive regimes, geographical mix of profits and net
favourable adjustments to prior year tax liabilities in a number of
major jurisdictions, many of which were one-time items
-
2021 Reported and Core Tax rates were impacted by one-off items in
2021, including the non-taxable gain on the divestment of Viela
Bio, Inc and updates to estimates of prior period tax liabilities
following settlements with tax authorities
-
The net cash paid for the year was $1,623m (2021: $1,743m)
representing 65% of Reported Profit before tax (2021: -658%). The
cash tax amount decreased due to refunds received in the year
relating to prior periods and phasing of payments between current
and future years
-
On 20 July 2022, the UK Government issued draft legislation in
relation to the new global minimum tax framework, expected to be
brought into effect in the UK from 2024. The UK corporation tax
rate continues to be expected to increase to 25%, effective April
2023. The Company is currently assessing the potential impact of
these draft rules upon its financial statements
Dividend
per share
-
A second interim dividend of $1.97 per share (162.8 pence, 20.69
SEK) has been declared, meaning a full-year dividend per share of
$2.90 (239.2 pence, 30.18 SEK). Dividend payments are normally paid
as follows:
-
First interim dividend - announced with half-year and
second-quarter results and paid in September
-
Second interim dividend - announced with full-year and
fourth-quarter results and paid in March
-
The record date for the second interim dividend for 2022, payable
on 27 March 2023, will be 24 February 2023. The ex-dividend date
will be 23 February 2023. The record date for the first interim
dividend for 2023, payable on 11 September 2023, will be 11 August
2023. The ex-dividend date will be 10 August 2023.
Table 13: Cash Flow summary
|
|
FY
2022
|
FY
2021
|
Change
|
|
|
$m
|
$m
|
$m
|
Reported Operating
Profit
|
|
3,757
|
1,056
|
2,701
|
Depreciation,
Amortisation and Impairment
|
|
5,480
|
6,530
|
(1,050)
|
Decrease in Working
Capital and Short-term Provisions
|
|
3,757
|
2,021
|
1,736
|
Gains
on Disposal of Intangible Assets
|
|
(104)
|
(513)
|
409
|
Gains
on Disposal of Investments in Associates and Joint
Ventures
|
|
-
|
(776)
|
776
|
Fair
value movements on contingent consideration arising from business
combinations
|
|
82
|
14
|
68
|
Non-Cash and Other
Movements
|
|
(692)
|
95
|
(787)
|
Interest
Paid
|
|
(849)
|
(721)
|
(128)
|
Taxation
Paid
|
|
(1,623)
|
(1,743)
|
120
|
Net
Cash Inflow from Operating Activities
|
|
9,808
|
5,963
|
3,845
|
Net
Cash Inflow/(Outflow) before Financing Activities
|
|
6,848
|
(5,095)
|
11,943
|
Net
Cash (Outflow)/Inflow from Financing Activities
|
|
(6,823)
|
3,649
|
(10,472)
|
The
increase in Net Cash Inflow from Operating Activities of $3,845m
primarily reflects an underlying
improvement
in business performance, including the contribution from Alexion
for the full year.
The
Reported Operating Profit of $3,757m in the year includes a
negative impact of $3,484m relating to the unwind of the inventory
fair value uplift recognised on the acquisition of Alexion. The
corresponding positive impact of $3,484m in Decrease in Working
Capital and Short-term Provisions offsets the negative impact on
Reported Operating Profit. Overall, the unwind of the fair value
uplift has no impact on Net Cash Inflow from Operating
Activities.
The
change in Working Capital and Short-term Provisions of $1,736m,
whilst being positively impacted by the aforementioned inventory
fair value uplift unwind, has been adversely impacted by the
reduction of Vaxzevria
working capital balances predominantly within Trade and other
payables.
The
change in Non-Cash and Other Movements of ($787m) is primarily
driven by changes in non-current Provisions, as well as increased
foreign exchange volatility on intercompany
transactions.
Capital
Expenditure
Capital
Expenditure amounted to $1,091m in the year (FY 2021: $1,091m)
including expenditure relating to Alexion.
Table 14: Net Debt summary
|
|
At 31
Dec
2022
|
At 31
Dec 2021
|
|
|
$m
|
$m
|
Cash
and cash equivalents
|
|
6,166
|
6,329
|
Other
investments
|
|
239
|
69
|
Cash
and investments
|
|
6,405
|
6,398
|
Overdrafts and
short-term borrowings
|
|
(350)
|
(387)
|
Lease
liabilities
|
|
(953)
|
(987)
|
Current
instalments of loans
|
|
(4,964)
|
(1,273)
|
Non-current
instalments of loans
|
|
(22,965)
|
(28,134)
|
Interest-bearing
loans and borrowings (Gross Debt)
|
|
(29,232)
|
(30,781)
|
Net
derivatives
|
|
(96)
|
61
|
Net
Debt
|
|
(22,923)
|
(24,322)
|
Net
Debt decreased by $1,399m in the year to $22,923m. Details of the
committed undrawn bank facilities are disclosed within the going
concern section of Note 1. Details of the Company's solicited
credit ratings are disclosed in Note 3.
Capital
allocation
The
Board's aim is to continue to strike a balance between the
interests of the business, financial creditors and the Company's
shareholders. The Company's capital allocation priorities include:
investing in the business and pipeline; maintaining a strong,
investment-grade credit rating; potential value-enhancing business
development opportunities; and supporting the progressive dividend
policy.
In
approving the declaration of dividends, the Board considers both
the liquidity of the company and the level of reserves legally
available for distribution. Dividends are paid to shareholders from
AstraZeneca PLC, a Group holding company with no direct operations.
The ability of AstraZeneca PLC to make shareholder distributions is
dependent on the creation of profits for distribution and the
receipt of funds from subsidiary companies. The consolidated Group
reserves set out in the Condensed consolidated statement of
financial position do not reflect the profit available for
distribution to the shareholders of AstraZeneca PLC.
Summarised financial information for
guarantee of securities of subsidiaries
AstraZeneca Finance
LLC ("AstraZeneca Finance") is the issuer of 0.700% Notes due 2024,
1.200% Notes due 2026, 1.750% Notes due 2028 and 2.250% Notes due
2031 (the "AstraZeneca Finance Notes"). Each series of AstraZeneca
Finance Notes has been fully and unconditionally guaranteed by
AstraZeneca PLC. AstraZeneca Finance is 100% owned by AstraZeneca
PLC and each of the guarantees by AstraZeneca PLC is full and
unconditional and joint and several.
The
AstraZeneca Finance Notes are senior unsecured obligations of
AstraZeneca Finance and rank equally with all of AstraZeneca
Finance's existing and future senior unsecured and unsubordinated
indebtedness. The guarantee by AstraZeneca PLC of the AstraZeneca
Finance Notes is the senior unsecured obligation of AstraZeneca PLC
and ranks equally with all of AstraZeneca PLC's existing and future
senior unsecured and unsubordinated indebtedness. Each guarantee by
AstraZeneca PLC is effectively subordinated to any secured
indebtedness of AstraZeneca PLC to the extent of the value of the
assets securing such indebtedness. The AstraZeneca Finance Notes
are structurally subordinated to indebtedness and other liabilities
of the subsidiaries of AstraZeneca PLC, none of which guarantee the
AstraZeneca Finance Notes.
AstraZeneca PLC
manages substantially all of its operations through divisions,
branches and/or investments in subsidiaries and affiliates.
Accordingly, the ability of AstraZeneca PLC to service its debt and
guarantee obligations is also dependent upon the earnings of its
subsidiaries, affiliates, branches and divisions, whether by
dividends, distributions, loans or otherwise.
Please
refer to the consolidated financial statements of AstraZeneca PLC
in our Annual Report on Form 20-F and reports on Form 6-K with our
quarterly financial results as filed or furnished with the
SEC65 for further
financial information regarding AstraZeneca PLC and its
consolidated subsidiaries. For further details, terms and
conditions of the AstraZeneca Finance Notes please refer to
AstraZeneca PLC's Form 6-K furnished to the SEC on 28 May
2021.
Pursuant to Rule
13-01 and Rule 3-10 of Regulation S-X under the Securities Act of
1933, as amended (the "Securities Act"), we present below the
summary financial information for AstraZeneca PLC, as Guarantor,
excluding its consolidated subsidiaries, and AstraZeneca Finance,
as the issuer, excluding its consolidated subsidiaries. The
following summary financial information of AstraZeneca PLC and
AstraZeneca Finance is presented on a combined basis and
transactions between the combining entities have been eliminated.
Financial information for non-guarantor entities has been excluded.
Intercompany balances and transactions between the obligor group
and the non-obligor subsidiaries are presented on separate
lines.
Table 15: Obligor group summarised Statement of comprehensive
income
|
|
FY
2022
|
|
|
$m
|
Total
Revenue
|
|
-
|
Gross
Profit
|
|
-
|
Operating
loss
|
|
(27)
|
Loss
for the period
|
|
(687)
|
Transactions with
subsidiaries that are not issuers or guarantors
|
|
1,071
|
Table 16: Obligor group summarised Statement of financial
position
|
|
At 31
Dec 2022
|
|
|
$m
|
Current
assets
|
|
4
|
Non-current
assets
|
|
-
|
Current
liabilities
|
|
(2,839)
|
Non-current
liabilities
|
|
(22,797)
|
Amounts
due from subsidiaries that are not issuers or
guarantors
|
|
7,806
|
Amounts
due to subsidiaries that are not issuers or guarantors
|
|
(293)
|
Foreign
exchange
The
Company's transactional currency exposures on working-capital
balances, which typically extend for up to three months, are hedged
where practicable using forward foreign exchange contracts against
the individual companies' reporting currency. Foreign exchange
gains and losses on forward contracts for transactional hedging are
taken to profit or loss. In addition, the Company's external
dividend payments, paid principally in pounds sterling and Swedish
krona, are fully hedged from announcement to payment
date.
Table 17: Currency sensitivities
The
Company provides the following currency-sensitivity
information:
|
|
|
Average
spot
rates
vs. USD
|
|
Annual impact of 5% strengthening in FY average rate vs. USD
($m) 66
|
Currency
|
Primary
Relevance
|
|
|
|
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
|
|
|
|
|
|
|
|
385
|
202
|
GBP
|
Operating
expense
|
|
0.81
|
0.82
|
(1)
|
|
46
|
(92)
|
SEK
|
Operating
expense
|
|
10.12
|
10.39
|
(3)
|
|
7
|
(55)
|
Sustainability
Since
the last quarterly report, AstraZeneca:
Access
to healthcare
-
Presented the main findings of health system research conducted by
the Partnership for Health System Sustainability and Resilience
(PHSSR), which the Company co-founded, at the second Global PHSSR
Summit in November. The results highlighted key themes across
workforce and health service delivery, finance and governance, and
the role of technology in strengthening health systems, as well as
the importance of prevention and early intervention in
non-communicable diseases
-
Achieved third position overall in the 2022 Access to Medicine
Index and was recognised as the industry leader in Product
Delivery, including for its application of tailored access
strategies for countries reflecting their income classifications
across all product categories. The Company's approach to patent
transparency and sharing of intellectual property assets, using
technology transfers, was also highlighted as key to ensuring
continuous supply of medicines in low- and middle-income countries.
It also performed well in the Governance of Access and Research
& Development categories
-
Chair Leif Johansson alongside Senior Executive Team members Marc
Dunoyer, Dave Fredrickson and Iskra Reic attended the World
Economic Forum (WEF) in Davos in January 2023, for engagements with
global, regional and national leaders. The Company focused on
investing in health as the foundation of strong and resilient
societies, and the need for collective early action to build more
sustainable and equitable healthcare systems, including through
collaborations such as the PHSSR and Sustainable Markets Initiative
(SMI). AstraZeneca hosted a high-level roundtable on investing in
non-communicable diseases attended by global health leaders, and
signed the Zero Health Gaps Pledge in support of the WEF Global
Health Equity Network vision to advance health equity
-
Committed to expand the Healthy Heart Africa programme into 10
countries over two years, starting in 2023, in addition to the nine
countries where the programme is currently active. Over 32 million
blood pressure screenings have been conducted since launch in 2015
and over 10,600 healthcare workers trained, as at end of December
2022
-
Reached more than nine million young people through the Young
Health Programme with health information and trained more than
260,000 young people as peer educators in 39 countries, by end of
December 2022
Environmental
protection
-
CEO Pascal Soriot hosted a high-level engagement on climate and
health at COP27, in his capacity as champion of the SMI Health
Systems Task Force, which made sector-first commitments, actions
and recommendations to deliver near-term targets and support the
transition to net-zero sustainable healthcare. The Company also
launched new commitments during COP27 in support of its Ambition
Zero Carbon strategy
-
Achieved a double-A rating for Climate Change and Water Security
from CDP for the seventh consecutive year, and an improved Forest
score of B for timber, B for palm oil and C for cattle products.
AstraZeneca received a CDP UK Leadership Award in recognition of
the double-A rating and commitment to environmental transparency.
AZ Forest has also published a pledge implementation update
report
-
Achieved a 100% electric vehicle fleet in the Netherlands, the
first Company location to do so, as part of the fleet
decarbonisation strategy to support Ambition Zero Carbon emissions
reduction targets
-
Earned the US Environmental Protection Agency's ENERGY STAR®
certification for superior energy efficiency for the Company's
Wilmington, US site, which is more energy-efficient than 85 percent
of similar properties nationwide
Ethics
and transparency
-
Featured in the latest Dow Jones Sustainability Index Series and
the Corporate Knights list of the Global 100 world's most
sustainable corporations
-
Marked International Day of People with Disabilities on 3 December,
which aims to promote an understanding of disability issues with an
emphasis on accessibility, including with an article on
Accessibility in the workplace: the importance of allyship,
highlighting key themes such as access to technology
-
Featured in the 2023 Bloomberg Gender-Equality Index, for the fifth
consecutive year, recognising the Company's continued commitment to
gender equality and transparency
Research
and development
This
section covers R&D events and milestones that have occurred
since the prior results announcement on 10 November 2022, up
to and including events on 8 February 2023.
A
comprehensive view of AstraZeneca's pipeline of medicines in human
trials can be found in the latest clinical trials appendix,
available on www.astrazeneca.com/investor-relations.
The clinical trials appendix includes tables with details of the
ongoing clinical trials for AstraZeneca medicines and new molecular
entities in the pipeline.
Oncology
AstraZeneca
presented new data across its diverse portfolio of cancer medicines
at two major medical congresses during the quarter: the 2022 San
Antonio Breast Cancer Symposium (SABCS) and the 64th American
Society of Hematology (ASH), both in December. At SABCS,
AstraZeneca presented 56 abstracts spanning five approved medicines
and seven pipeline medicines with four late-breaking oral
presentations. At ASH, AstraZeneca presented 47 abstracts
showcasing new data across its haematology portfolio and clinical
pipeline.
Significant new
trials that achieved first patient dosed during the period
included:
-
TROPION-Breast03, a Phase III trial of datopotamab deruxtecan with
or without Imfinzi for patients with Stage I-III triple negative
breast cancer
-
AVANZAR, a Phase III trial of datopotamab deruxtecan in combination
with Imfinzi and chemotherapy for 1st-line NSCLC regardless of
histology and PD-L1 expression
Tagrisso and savolitinib
Event
|
|
|
Commentary
|
Fast
Track Designation
|
US
|
|
Tagrisso in combination with savolitinib for the treatment
of patients with locally advanced or metastatic NSCLC whose tumours
have MET overexpression and/or amplification, as detected by an
FDA-approved test, and who have had disease progression during or
following prior Tagrisso.
|
Imfinzi and Imjudo
(tremelimumab)
Event
|
|
|
Commentary
|
Approval
|
US
|
|
Imfinzi in combination with Imjudo plus platinum-based chemotherapy for the treatment
of adult patients with Stage IV NSCLC with no sensitising
EGFR70 mutations or anaplastic lymphoma kinase.
(POSEIDON, November 2022)
|
Approval
|
EU
|
|
Imfinzi for the 1st-line treatment of adult patients with
unresectable or metastatic BTC in combination with chemotherapy.
(TOPAZ-1, December 2022)
|
Approval
|
JP
|
|
Imfinzi with or without Imjudo for the treatment of adult patients with
unresectable HCC. (HIMALAYA, December 2022)
Imfinzi for the treatment of adult
patients with curatively unresectable BTC in combination with
chemotherapy. (TOPAZ-1, December
2022)
Imfinzi for the treatment of adult patients with
unresectable, advanced or recurrent NSCLC in combination with
chemotherapy. (POSEIDON, December 2022)
|
Read-out
|
PEARL
Phase III trial
|
|
The PEARL Phase III trial for Imfinzi did not achieve statistical significance for the
primary endpoints of improving overall survival versus
platinum-based chemotherapy as a monotherapy for the treatment of
patients with Stage IV NSCLC whose tumour cells express high levels
(25% or more) of PD-L171, or in a subgroup of patients at low risk of
early mortality. (December 2022)
|
Lynparza
Event
|
|
|
Commentary
|
Approval
|
EU
|
|
Lynparza in combination with abiraterone for the treatment
of mCRPC in adult men for whom chemotherapy is not clinically
indicated. (PROpel, December 2022)
|
|
US
|
|
The FDA indicated it will extend the PDUFA date by
three months to March 2023 in order to provide further time for a
full review of the sNDA73 for Lynparza in combination with abiraterone for the treatment
of mCRPC. (PROpel, December 2022)
|
Calquence
Event
|
|
|
Commentary
|
Presentation:
ASH
|
Real-world evidence
and long-term follow-up data
|
|
Real-world evidence and long-term follow-up data
support consistent efficacy and safety profile of
Calquence.
|
Approval
|
JP
|
|
Calquence for the treatment of adult patients with
treatment-naïve chronic lymphocytic leukaemia
(ELEVATE-TN)
|