TIDMAZN
RNS Number : 3756P
AstraZeneca PLC
09 February 2023
AstraZeneca
9 February 2023 07:00 GMT
Full year and Q4 2022 results
Strong performance and pipeline progress in 2022 underpins 2023
outlook
On track to deliver industry-leading revenue growth through 2025
and beyond
Revenue and EPS summary
FY 2022 Q4 2022
------ ------- ------- ------ ------- ----
% Change % Change
$m Actual CER [1] $m Actual CER
----------------------------- ------ ------- ------- ------ ------- ----
* Product Sales 42,998 18 24 10,798 (6) 2
* Collaboration Revenue 1,353 54 56 409 (20) (19)
------------------------------ ------ ------- ------- ------ ------- ----
Total Revenue 44,351 19 25 11,207 (7) 1
------------------------------ ------ ------- ------- ------ ------- ----
Reported [2] EPS [3] $2.12 n/m n/m $0.58 n/m n/m
Core [4] EPS $6.66 26 33 $1.38 (17) (5)
------------------------------ ------ ------- ------- ------ ------- ----
Financial performance (FY 2022 figures unless otherwise stated ,
growth numbers and commentary at CER)
-- Total Revenue increased 25% to $44,351m, with growth coming
from all therapy areas, and from the addition of Alexion, which was
incorporated into the Group's results from 21 July 2021
-- Total Revenue in the fourth quarter was impacted by the
decline in Vaxzevria. Excluding Vaxzevria, Total Revenue in the
quarter increased 17%
-- Oncology Total Revenue including milestone receipts increased
20%; Oncology Product Sales increased 19%. Total Revenue CVRM [5]
increased 19% [6] , R&I [7] increased 3%, and Rare Disease
increased 10% (6)
-- Core Gross Margin of 80%, up six percentage points,
reflecting the lower revenue from Vaxzevria and the increased share
of Oncology and Rare Disease medicines. Core Gross Margin of 77% in
the fourth quarter was impacted by inventory write downs and
manufacturing termination fees for Evusheld
-- Core Total Operating Expense increased 23%, reflecting the
addition of Alexion, and continued investment in new launches and
the pipeline to deliver sustainable long-term growth
-- Core Operating Margin of 30%, up four percentage points
-- Core EPS increased 33% to $6.66. Second interim dividend
declared of $1.97 per share, making a total dividend declared for
FY 2022 of $2.90 for the year. The Core Tax Rate for the year was
17%, reflecting IP incentive regimes, geographical mix of profits
and adjustments to prior year tax liabilities
FY 2023 Guidance summary (Growth numbers at CER)
-- Total Revenue is expected to increase by a low-to-mid single-digit percentage
-- Total Revenue excluding COVID-19 medicines [8] is expected to
increase by a low double-digit percentage
-- Core EPS is expected to increase by a high single-digit to low double-digit percentage
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
"2022 was a year of continued strong company performance and
execution of our long-term growth strategy . We made excellent
pipeline progress with a record 34 approvals in major markets and
we are initiating new late-stage trials for high potential
medicines such as camizestrant, datopotamab deruxtecan and
volrustomig.
In 2023, we expect to see another year of double-digit revenue
growth at CER, excluding our COVID-19 medicines. We will continue
to invest behind our pipeline and recent launches while continuing
to improve profitability. We plan to initiate more than thirty
Phase III trials this year, of which ten have the potential to
deliver peak year sales over one billion dollars.
Our R&D success and revenue increase in 2022 demonstrate
that we are on track to deliver industry-leading revenue growth
through 2025 and beyond, and have set AstraZeneca on a path to
deliver at least fifteen new medicines before the end of the
decade."
Key milestones achieved since the prior results
-- Key regulatory approvals: US approval for Airsupra (PT027) in
asthma. EU approvals for Lynparza [9] in mCRPC [10] (PROpel),
Enhertu in gastric cancer (DESTINY-Gastric01) and HER2 [11] -low
breast cancer (DESTINY-Breast04), Imfinzi in biliary tract cancer
(TOPAZ-1), Imfinzi+Imjudo in HCC [12] and Forxiga in heart failure
with preserved ejection fraction. Five approvals in Japan,
including Imfinzi and Imjudo in liver cancer (TOPAZ-1) and NSCLC
[13] (POSEIDON) and Calquence for treatment-naïve CLL
(ELEVATE-TN)
-- Other regulatory milestones: US Fast Track designations for
capivasertib in HR-positive HER2-negative breast cancer
(CAPItello-291), tozorakimab in treatment/prevention of acute
respiratory failure in patients with viral lung infection (TILIA),
and Orpathys plus Tagrisso in NSCLC with MET [14] overexpression
(SAVANNAH/SAFFRON); US Orphan Drug Designation for Saphnelo in
idiopathic inflammatory myopathies; US Emergency Use Authorisation
for Evusheld revised - as of January 2023, Evusheld is not
currently authorised for use in the US.
Guidance
The Company provides guidance for FY 2023 at CER, based on the
average exchange rates through 2022.
Total Revenue is expected to increase by a low-to-mid
single-digit percentage
Excluding COVID-19 medicines, Total Revenue is expected to
increase by a low double-digit percentage
Core EPS is expected to increase by a high single-digit to low
double-digit percentage
-- While challenging to forecast, Total Revenue from COVID-19
medicines (Vaxzevria, Evusheld and AZD3152, the COVID-19 LAAB [15]
currently in development) is expected to decline significantly in
FY 2023, with minimal revenue from Vaxzevria
-- Total Revenue from China is expected to return to growth and
increase by a low single-digit percentage in FY 2023
-- Collaboration Revenue and Other Operating Income are both
expected to increase, driven by continued growth of our partnered
medicines, success-based milestones, and certain anticipated
transactions
-- Core Operating Expenses are expected to increase by a
low-to-mid single-digit percentage, driven by investment in recent
launches and the ungating of new trials
-- The Core Tax Rate is expected to be between 18-22%
The Company is unable to provide guidance on a Reported basis
because it cannot reliably forecast material elements of the
Reported result, including any fair value adjustments arising on
acquisition-related liabilities, intangible asset impairment
charges and legal settlement provisions. Please refer to the
cautionary statements section regarding forward-looking statements
at the end of this announcement.
Currency impact
If foreign exchange rates for February to December 2023 were to
remain at the average rates seen in January 2023, it is anticipated
that FY 2023 Total Revenue and FY 2023 Core EPS would both incur a
low single-digit adverse impact versus the performance at CER.
The Company's foreign exchange rate sensitivity analysis is
provided in Table 17.
Table 1 : Key elements of Total Revenue performance in Q4
2022
% Change
Revenue type $m Actual CER
----------------------- ------ ------ ---- --------------------------------------
* Decline of 6% (2% increase
at CER) due to lower sales of
Vaxzevria [16]
* Strong growth in Oncology,
Product Sales 10,798 (6) 2 CVRM and Rare Disease
* $188m for Enhertu (Q4 2021:
$60m)
* $37m for Tezspire (Q4 2021:
$nil)
Collaboration Revenue 409 (20) (19) * Milestone of $105m for Lynparza
* Excluding Vaxzevria, Q4 2022
Total Revenue increased by 8%
Total Revenue 11,207 (7) 1 (17% at CER) - see below
------------------------ ------ ------ ---- --------------------------------------
Therapy areas $m Actual CER
----------------------- ------ ------ ---- --------------------------------------
* Strong performance across key
Oncology 4,046 4 12 medicines and regions
* Farxiga up 39% (52% CER) ,
Lokelma up 50% (63% at CER),
roxadustat up 61% (83% CER),
Brilinta decreased 1% (increased
CVRM (6) 2,284 12 22 4% at CER)
* Growth in Fasenra, Breztri
and Saphnelo offset by decline
in Pulmicort of 33% (28% at CER)
primarily due to the impact of
R&I 1,485 (7) (1) VBP [17] implementation in China
* $734m from Evusheld (Q4 2021:
$135m)
* $95m from Vaxzevria (Q4 2021:
V&I [18] 1,163 (50) (43) $1,762m)
* 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
Rare Disease (6) 1,816 4 10 demand and geographic expansion
Other Medicines 412 (2) 12
Total Revenue 11,207 (7) 1
------------------------ ------ ------ ---- --------------------------------------
Regions inc. Vaxzevria $m Actual CER
----------------------- ------ ------ ---- --------------------------------------
* Decline due to lower sales
of Vaxzevria (growth rates excluding
Emerging Markets 2,733 (25) (18) Vaxzevria shown below)
* Second consecutive quarter
- China 1,194 (9) 3 of growth at CER
- Ex-China Emerging * Decline due to lower sales
Markets 1,538 (35) (29) of Vaxzevria
US 4,788 22 22
* Decline due to lower sales
Europe 2,308 (20) (8) 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
* Second consecutive quarter
- China 1,194 (8) 4 of growth at CER
* Strong growth in Oncology and
CVRM
- Ex-China Emerging * $246m from Evusheld in Q4 (Q4
Markets 1,484 24 33 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 Core Core Comments [19]
change change
---------- -------- ----------- -------- ----------- ----------------------------------------------------------
* Excluding Vaxzevria, Q4
2022 Total Revenue increased
by 8% (17% at CER)
* See Table 1 and the Total
Total -7% Actual -7% Actual Revenue section of this document
Revenue $11,207m 1% CER $11,207m 1% CER for further details
---------- -------- ----------- -------- ----------- ----------------------------------------------------------
Gross 73% 13pp Actual 77% 3pp Actual + Increasing mix of sales
margin 15pp CER 4pp CER from Oncology and Rare Disease
[20] 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
---------- -------- ----------- -------- ----------- ----------------------------------------------------------
+ Increased investment in
the pipeline
* Core R&D-to-Total Revenue
R&D 2% Actual 5% Actual ratio of 23%
expense $2,625m 9% CER $2,526m 12% CER (Q4 2021: 20%)
---------- -------- ----------- -------- ----------- ----------------------------------------------------------
+ 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
SG&A -10% Actual 6% Actual differences in cost phasing
expense $4,621m -3% CER $3,583m 15% CER during H2 2021 and H2 2022
---------- -------- ----------- -------- ----------- ----------------------------------------------------------
Other
operating * Reported and Core OOI includes
income 29% Actual -11% Actual income from sale of t he Waltham
[21] $189m 33% CER $130m -7% CER site
---------- -------- ----------- -------- ----------- ----------------------------------------------------------
Operating 12pp Actual -4pp Actual * See Gross Margin and Expenses
margin 10% 14pp CER 23% -3pp CER commentary above
---------- -------- ----------- -------- ----------- ----------------------------------------------------------
Net -6% Actual * Reported impacted by a reduction
finance stable at 5% Actual in the discount unwind on
expense $315m CER $245m 9% CER acquisition-related liabilities
---------- -------- ----------- -------- ----------- ----------------------------------------------------------
* 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
-7pp Actual can be expected to continue
Tax rate -16% n/m 10% -6pp CER quarter to quarter
---------- -------- ----------- -------- ----------- ----------------------------------------------------------
* Further details of differences
-17% Actual between Reported and Core
EPS $0.58 n/m $1.38 -5% CER are shown in Table 12
---------- -------- ----------- -------- ----------- ----------------------------------------------------------
Table 3 : Pipeline highlights since prior results
announcement
Event Medicine Indication / Trial Event
--------------- ------------ ------------------------------- ----------------------------
Regulatory Imfinzi NSCLC (1st-line) (POSEIDON) Regulatory approval (US,
approvals +/- Imjudo JP)
and other
regulatory
actions
Imfinzi Hepatocellular carcinoma Regulatory approval (JP)
+ Imjudo (1st-line) (HIMALAYA)
Imfinzi Biliary tract cancer (TOPAZ-1) Regulatory approval (EU,
JP)
Lynparza mCRPC (1st-line) (PROpel) Regulatory approval (EU)
Enhertu HER2-positive breast cancer Regulatory approval (JP)
(2nd-line) (DESTINY-Breast03)
Enhertu HER2-low breast cancer Regulatory approval (EU)
(3rd-line) (DESTINY-Breast04)
Enhertu HER2-positive/HER2-low Regulatory approval (EU)
gastric
(2nd-line) (DESTINY-Gastric01,
DESTINY-Gastric02)
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 Enhertu HER2-mutated NSCLC (2nd-line+) Regulatory submission
submissions (DESTINY-Lung01) (EU, JP)
or acceptances
---------------
Calquence CLL (ASC) Regulatory submission
(CN)
---------------
Beyfortus RSV [24] (MELODY/MEDLEY) Regulatory submission
(US)
Soliris NMOSD [25] Regulatory submission
(CN)
--------------- ------------ ------------------------------- ----------------------------
Major Phase Imfinzi NSCLC (1st-line) (PEARL) Primary endpoint not met
III data
readouts
and other
developments
---------------
capivasertib HR [26] +/HER2-negative Fast Track Designation
breast cancer (1st-line) (US)
(CAPItello-291)
---------------
Orpathys NSCLC with MET overexpression Fast Track Designation
+ Tagrisso (SAVANNAH/SAFFRON) (US)
tozorakimab Treatment/prevention of Fast Track Designation
acute respiratory failure (US)
in patients with viral
lung infection (TILIA)
Saphnelo Idiopathic inflammatory Orphan Drug Designation
myopathies (US)
Evusheld Pre-exposure prophylaxis Revision of Emergency
of COVID-19 Use Authorisation (US)
- Evusheld is not currently
authorised in the US until
further notice from the
FDA [27]
--------------- ------------ ------------------------------- ----------------------------
Corporate and business development
In January 2023, AstraZeneca entered into a definitive agreement
to acquire CinCor Pharma, Inc. (CinCor), a US-based clinical-stage
biopharmaceutical company focused on developing novel treatments
for resistant and uncontrolled hypertension as well as chronic
kidney disease. The acquisition will bolster AstraZeneca's
cardiorenal pipeline by adding CinCor's candidate drug, baxdrostat
(CIN-107), an aldosterone synthase inhibitor for blood pressure
lowering in treatment-resistant hypertension.
AstraZeneca has initiated a tender offer to acquire all of
CinCor's outstanding shares for a price of $26 per share in cash at
closing, plus a non-tradable contingent value right of $10 per
share in cash payable upon a specified regulatory submission of a
baxdrostat product. Combined, the upfront and maximum potential
contingent value payments represent, if achieved, a transaction
value of approximately $1.8bn. As part of the transaction,
AstraZeneca will acquire the cash and marketable securities on
CinCor's balance sheet, which totalled approximately $522m as of 30
September 2022.
In January 2023, AstraZeneca completed the acquisition of
Neogene Therapeutics Inc. (Neogene), a global clinical-stage
biotechnology company pioneering the discovery, development and
manufacturing of next-generation T-cell receptor therapies that
offer a novel cell therapy approach for targeting cancer.
AstraZeneca acquired outstanding equity of Neogene for a total
consideration of up to $320m, on a cash and debt free basis. This
includes an initial payment of $200m on deal closing, and a further
up to $120m in both contingent milestones-based and non-contingent
consideration.
Following the approval of Airsupra in January 2023, AstraZeneca
has notified Avillion of its intention to commercialise Airsupra in
the US. Under the terms of the agreement with Avillion, AstraZeneca
will pay single-digit royalties and milestones based on future
sales and developments.
In December 2022, AstraZeneca completed the sale of its R&D
facility in Waltham, Massachusetts, US, to Alexandria Real Estate
Equities, Inc, (ARE), a leading owner, operator and developer of
life science campuses. ARE will lease the site back to AstraZeneca
for a four-year term while construction is being completed on the
new AstraZeneca R&D Centre and Alexion Headquarters in Kendall
Square, Cambridge, Massachusetts, announced in April 2022.
In January 2023, AstraZeneca completed the sale of its West
Chester site in Ohio, US, to National Resilience, Inc., a
technology-focused manufacturing company dedicated to broadening
access to complex medicines. The West Chester site will continue to
manufacture medicines for AstraZeneca.
Post Alexion Acquisition Group Review (PAAGR)
In conjunction with the acquisition of Alexion in 2021,
AstraZeneca initiated a comprehensive review, aimed at integrating
systems, structure and processes, optimising the global footprint
and prioritising resource allocations and investments. These
activities are expected to be substantially complete by the end of
2025, with a number of planned activities having commenced in late
2021 and during 2022.
During 2022, the Company has refined the scope and estimates of
the planned activities, resulting in an increase to the expected
one-time restructuring costs over the life of the programme of
$0.5bn, of which $0.3bn are non-cash costs, an increase in capital
investments of $0.1bn, and an increase to the anticipated annual
run-rate pre-tax benefits by the end of 2025 of $0.7bn.
In addition, initial financial estimates for the Company's
planned upgrade of its Enterprise Resource Planning IT systems have
been completed, resulting in anticipated incremental capital
investments for software assets of $0.6bn and one-time
restructuring cash costs of $0.3bn. This investment builds strongly
on the PAAGR and is expected to be substantially complete by the
end of 2030, realising significant strategic and compliance-related
benefits from transforming core enterprise-wide processes,
harmonising systems architecture and enabling future digital
capabilities.
Consequently, the total programme activities are now anticipated
to incur one-time restructuring costs of approximately $2.9bn, of
which approximately $1.9bn are cash costs and $1.0bn are non-cash
costs, and capital investments of approximately $0.9bn.
Run-rate pre-tax benefits, before reinvestment, are now expected
to be approximately $1.9bn by the end of 2025. In line with
established practice, restructuring costs will be excluded from our
Core (non-GAAP) financial measures.
During 2022, AstraZeneca recorded restructuring charges of
approximately $0.7bn in relation to the PAAGR (2021: $1.0bn),
bringing the cumulative charges to date under this programme to
$1.7bn. Of these costs, $0.7bn are non-cash costs arising primarily
from impairments and accelerated depreciation on affected assets.
As at 31 December 2022, the PAAGR has realised annual run-rate
pre-tax benefits, before reinvestment, of $0.8bn.
Sustainability summary
In November 2022, AstraZeneca achieved third position overall in
the 2022 Access to Medicine Index.
In January 2023, Chair Leif Johansson alongside Senior Executive
Team members Marc Dunoyer, Dave Fredrickson and Iskra Reic attended
the World Economic Forum in Davos, focusing on investing in health
as the foundation of strong and resilient societies, and the need
for collective early action to build more sustainable and equitable
healthcare systems, including through collaborations such as the
Partnership for Health System Sustainability and Resilience and the
Sustainable Markets Initiative.
Management changes
Katarina Ageborg, EVP Global Sustainability and Chief Compliance
Officer, has announced her retirement. Jeffrey Pott, Chief Human
Resources Officer and General Counsel, will assume responsibility
as Chief Compliance Officer in addition to his current
responsibilities. Pam Cheng, Executive Vice-President, Operations
and Information Technology, will assume responsibility for
leadership of Sustainability strategy and function in addition to
her existing responsibilities. The Board thanks Katarina for her
lasting legacy, having positioned AstraZeneca amongst the global
leaders in sustainability, backed by world-leading platforms and
science-based targets.
Conference call
A conference call and webcast for investors and analysts will
begin today, 9 February 2023, at 11:45 GMT. Details can be accessed
via astrazeneca.com .(R)
Reporting calendar
The Company intends to publish its results for the first quarter
of 2023 on Thursday 27 April 2023.
Operating and financial review
All narrative on growth and results in this section is based on
actual exchange rates, and financial figures are in US$ millions
($m), unless stated otherwise. Unless stated otherwise, the
performance shown in this announcement covers the twelve-month
period to 31 December 2022 ('the year' or 'FY 2022') compared to
the twelve-month period to 31 December 2021 (FY 2021), or the
three-month period to 31 December 2022 ('the fourth quarter' or 'Q4
2022') compared to the three-month period to 31 December 2021 ('Q4
2021').
Core financial measures, EBITDA, Net Debt, Gross Margin,
Operating Margin and CER are non-GAAP financial measures because
they cannot be derived directly from the Group's Condensed
Consolidated Financial Statements. Management believes that these
non-GAAP financial measures, when provided in combination with
Reported results, provide investors and analysts with helpful
supplementary information to understand better the financial
performance and position of the Group on a comparable basis from
period to period. These non-GAAP financial measures are not a
substitute for, or superior to, financial measures prepared in
accordance with GAAP.
Core financial measures are adjusted to exclude certain
significant items, such as:
-- Amortisation and impairment of intangible assets, including
impairment reversals but excluding any charges relating to IT
assets
-- Charges and provisions related to restructuring programmes,
which includes charges that relate to the impact of restructuring
programmes on capitalised IT assets
-- Alexion acquisition-related items, primarily fair value
adjustments on acquired inventories and fair value impact of
replacement employee share awards
-- Other specified items, principally the imputed finance charge
relating to contingent consideration on business combinations,
legal settlements and the one-off deferred tax credit arising from
the internal reorganisation to integrate Alexion
-- The tax effects of the adjustments above are excluded from the Core Tax charge
Details on the nature of Core financial measures are provided on
page 54 of the Annual Report and Form 20-F Information 2021 .
Reference should be made to the Reconciliation of Reported to
Core financial measures table included in the financial performance
section in this announcement.
Gross Margin, previously termed Gross Profit Margin, is the
percentage by which Product Sales exceeds the Cost of sales,
calculated by dividing the difference between the two by the sales
figure. The calculation of Reported and Core Gross Margin excludes
the impact of Collaboration Revenue and any associated costs,
thereby reflecting the underlying performance of Product Sales.
EBITDA is defined as Reported Profit before tax after adding
back Net finance expense, results from Joint Ventures and
Associates and charges for Depreciation, Amortisation and
Impairment. Reference should be made to the Reconciliation of
Reported Profit before tax to EBITDA included in the financial
performance section in this announcement.
Net Debt is defined as Interest-bearing loans and borrowings and
Lease liabilities, net of Cash and cash equivalents, Other
investments, and net derivative financial instruments. Reference
should be made to Note 3 'Net Debt' included in the Notes to the
Condensed Consolidated Financial Statements in this
announcement.
The Company strongly encourages investors and analysts not to
rely on any single financial measure, but to review AstraZeneca's
financial statements, including the Notes thereto, and other
available Company reports, carefully and in their entirety.
Due to rounding, the sum of a number of dollar values and
percentages in this announcement may not agree to totals.
Total Revenue
Table 4 : Therapy area and medicine performance
FY 2022 Q4 2022
----------------------------- -----------------------------
% Change % Change
Product Sales $m % Total Actual CER $m % Total Actual CER
---------------------- ------ ------- ------ ---- ------ ------- ------ ----
Oncology 14,631 33 13 19 3,746 33 9 18
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
- Tagrisso 5,444 12 9 15 1,342 12 2 12
- Imfinzi [28] 2,784 6 15 21 752 7 19 27
- Lynparza 2,638 6 12 18 689 6 10 17
- Calquence 2,057 5 66 69 588 5 49 53
- Enhertu 79 - >4x >4x 28 - >3x >3x
- Orpathys 33 - >2x >2x (1) - n/m n/m
- Zoladex 927 2 (2) 6 210 2 (9) 4
- Faslodex 334 1 (22) (14) 74 1 (27) (14)
- Iressa 114 - (38) (34) 24 - (32) (24)
- Arimidex 99 - (29) (24) 14 - (57) (50)
- Casodex 78 - (45) (40) 16 - (28) (16)
- Others 44 - (14) (6) 10 - (29) (18)
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
BioPharmaceuticals:
CVRM (6) 9,188 21 13 19 2,281 20 12 22
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
- Farxiga 4,381 10 46 56 1,177 11 39 52
- Brilinta 1,358 3 (8) (4) 345 3 (1) 4
- Lokelma 289 1 65 75 81 1 50 63
- Roxadustat 197 - 13 18 49 - 65 87
- Andexxa (6) 150 - 5 14 39 - - 14
- Crestor 1,048 2 (4) 2 224 2 (13) (2)
- Seloken/Toprol-XL 862 2 (9) (4) 157 1 (23) (12)
- Bydureon 280 1 (27) (26) 73 1 (20) (20)
- Onglyza 257 1 (28) (25) 52 - (31) (24)
- Others 366 1 (10) (7) 84 1 (13) (6)
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
BioPharmaceuticals:
R&I 5,765 13 (4) - 1,447 13 (9) (3)
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
- Symbicort 2,538 6 (7) (2) 620 6 (9) (2)
- Fasenra 1,396 3 11 15 381 3 7 12
- Breztri 398 1 96 >2x 116 1 59 68
- Saphnelo 116 - >10x >10x 48 - >6x >6x
- Tezspire 4 - n/m n/m 4 - n/m n/m
- Pulmicort 645 1 (33) (31) 166 1 (33) (28)
- Daliresp/Daxas 189 - (17) (16) 28 - (52) (52)
- Bevespi 58 - 7 9 14 - (5) (1)
- Others 421 1 (29) (27) 70 1 (53) (47)
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
BioPharmaceuticals:
V&I 4,736 11 2 8 1,129 10 (51) (44)
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
- Vaxzevria 1,798 4 (54) (52) 85 1 (95) (94)
- Evusheld 2,185 5 >10x >10x 734 7 >8x >9x
- Synagis 578 1 41 59 194 2 (19) (3)
- FluMist 175 - (31) (20) 116 1 (35) (24)
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
Rare Disease (6) 7,053 16 4 10 1,816 16 4 10
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
- Soliris (6) 3,762 8 (11) (5) 844 8 (22) (16)
- Ultomiris (6) 1,965 4 34 42 593 5 52 62
- Strensiq (6) 958 2 16 18 272 2 24 27
* Koselugo 208 - 93 96 58 1 74 77
- Kanuma (6) 160 - 16 19 49 - 45 44
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
Other Medicines 1,625 4 (5) 4 379 3 (7) 7
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
- Nexium 1,285 3 (3) 8 300 3 (9) 7
- Others 340 1 (10) (7) 79 1 (1) 5
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
Product Sales 42,998 97 18 24 10,798 96 (6) 2
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
Collaboration Revenue 1,353 3 54 56 409 4 (20) (19)
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
Total Revenue 44,351 100 19 25 11,207 100 (7) 1
----------------------- ------ ------- ------ ---- ------ ------- ------ ----
Table 5 : Collaboration Revenue
FY 2022 Q4 2022
---------------------------- --------------------------
% Change % Change
$m % Total Actual CER $m % Total Actual CER
---------------------- ----- ------- ------ ---- --- ------- ------ ----
Enhertu : alliance
revenue [29] 519 38 >2x >2x 187 46 >3x >3x
Tezspire: alliance
revenue 79 6 n/m n/m 37 9 n/m n/m
Lynparza : regulatory
milestones 355 26 n/m n/m 105 26 n/m n/m
Tralokinumab: sales
milestones 110 8 n/m n/m - - - -
Vaxzevria : royalties 76 6 19 16 10 2 n/m n/m
Other royalty income 72 5 (42) (41) 17 4 (75) (74)
Other Collaboration
Revenue 142 10 49 69 53 13 >10x >10x
----------------------- ----- ------- ------ ---- --- ------- ------ ----
Total 1,353 100 54 56 409 100 (20) (19)
----------------------- ----- ------- ------ ---- --- ------- ------ ----
Table 6 : Total Revenue by therapy area
FY 2022 Q4 2022
------------------- ----------------------------- ------------------------------
% Change % Change
$m % Total Actual CER $m % Total Actual CER
------------------- ------ ------- ------- --- ------ ------- ------- ----
Oncology 15,539 35 15 20 4,046 36 4 12
BioPharmaceuticals
(6) 20,010 45 5 11 4,932 44 (17) (9)
-------------------- ------ ------- ------- --- ------ ------- ------- ----
- 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
------------------ ------ ------- ------- --- ------ ------- ------- ---
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 * Increased use in 1st-line setting and launch progress
RoW 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 * New reimbursements
RoW
---------------- ------------------------------------------------------------
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 * New launches and high levels of HRD testing in Japan
RoW
---------------- ----------------------------------------------------------------
Enhert u
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 * In Japan, AstraZeneca receives a mid-single-digit
RoW percentage royalty on sales made by Daiichi Sankyo
---------------- ---------------------------------------------------------------------
Calquence
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- ----- ------ -----------
FY 2022 $m 2,057 45 1,657 286 69
Actual change 66% >2x 52% >2x >3x
CER change 69% >2x 52% >2x >4x
--------------- --------- ---------------- ----- ------ -----------
Region Drivers and commentary
--------- --------------------------------------------------------------
Worldwide * Increased penetration globally; leading BTKi [39]
in key markets
US * Increased share of new patient starts
* Inventory build in Q3 following maleate tablet formulation
launch in August; Q4 observed partial inventory work
down
Europe * Increased share of new patient starts
--------- --------------------------------------------------------------
Orpathys
Total Revenue of $33m (FY 2021: $16m), growth was driven by the
2021 launch in China, where it is approved for patients with lung
cancer and MET gene alterations. Orpathys has been included in the
updated NRDL in China for the treatment of patients with NSCLC with
MET exon 14 skipping alterations. The updated NRDL will take effect
from 1 March 2023.
Other Oncology medicines
FY 2022 % Change
Total Revenue $m Actual CER
--------------- --- ------ ----- ----------------------------------------------
Zoladex 957 (1%) 7% * Increased use in ex-China Emerging Markets,
offsetting a price cut in Japan
Faslodex 334 (22%) (14%) * Generic competition
Iressa 114 (38%) (34%) * Continued share loss to next-generation
TKIs [40]
Arimidex 99 (29%) (24%)
Casodex 78 (45%) (40%) * Ongoing impact from VBP implementation
Other Oncology 44 (14%) (6%)
---------------- --- ------ ----- ----------------------------------------------
BioPharmaceuticals
Including V&I medicines, BioPharmaceuticals Total Revenue
increased by 5% (11% at CER) in FY 2022 to $20,010m, representing
45% of overall Total Revenue (FY 2021: 51%). Growth was driven by
strong Farxiga performance, Evusheld revenues offsetting the
decline in Vaxzevria, and growth from newer R&I medicines
offsetting decreases in Pulmicort and other older R&I
medicines.
BioPharmaceuticals - CVRM
CVRM Total Revenue increased by 13% (19% at CER) to $9,211m in
FY 2022, driven by a strong Farxiga performance, and represented
21% of overall Total Revenue (FY 2021: 22%).
Farxiga
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- ----- ------ -----------
FY 2022 $m 4,386 1,665 1,071 1,297 353
Actual change 46% 39% 46% 60% 31%
CER change 56% 47% 46% 81% 48%
--------------- --------- ---------------- ----- ------ -----------
Region Drivers and commentary
---------------- -----------------------------------------------------------------
Worldwide * Farxiga volume is growing faster than the overall
SGLT2 [41] market in all major regions
* Additional benefit from continued growth in the overall
SGLT2 inhibitor class
* Further HF [42] and CKD launches and supportive updates
to treatment guidelines including from ESC [43] and
AHA [44] /ACC [45] /HFSA [46] . HF and CKD indications
now launched in >100 markets
Emerging Markets * Growth despite generic competition in some markets.
Solid growth in ex-China Emerging Markets, particularly
Latin America
US * Regulatory approval for HFrEF [47] in May 2020, treatment
of CKD in May 2021. Both approvals included patients
with and without T2D [48]
* Farxiga continued to gain in-class brand share, driven
by HF and CKD launches
Europe * The beneficial addition of cardiovascular outcomes
trial data to the label, the HFrEF regulatory approval
in November 2020, and CKD regulatory approval in August
2021
* Forxiga continued gaining in-class market share in
the period
Established * In Japan, AstraZeneca sells to collaborator Ono Pharmaceutical
RoW Co., Ltd, which records in-market sales. Continued volume
growth driven by HF and CKD launches
---------------- -----------------------------------------------------------------
Brilinta
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- --- ------ -----------
FY 2022 $m 1,358 286 744 282 46
Actual change (8%) (13%) 1% (18%) (27%)
CER change (4%) (10%) 1% (8%) (22%)
--------------- --------- ---------------- --- ------ -----------
Region Drivers and commentary
---------------- -------------------------------------------------------
Emerging Markets * Adverse impact from Brilinta's inclusion in China's
VBP programme
* Growth in ex-China Emerging Markets
US, Europe * Q4 US sales growth favourably impacted by a one-time
adjustment. Some market recovery of oral antiplatelet
therapies following the pandemic
---------------- -------------------------------------------------------
Lokelma
Total Revenue increased 65% (75% at CER) to $289m in FY 2022,
driven by Lokelma extending its branded market share lead in the US
and also achieving total potassium binder market share leadership
in the period. Continued progress in Europe from recent launches
across the region where Lokelma extended its market share in the
period. In China, Lokelma was admitted to the NRDL with effect from
1 January 2022 and is now the leading potassium binder in the
country.
Roxadustat
Total Revenue increased 12% (17% at CER) to $202m, with
roxadustat benefitting from increased volumes in China following
NRDL price cuts.
Andexxa
On a pro forma basis, Andexxa Total Revenue increased 12% (21%
at CER) to $160m.
Other CVRM medicines
FY 2022 % Change
Total Revenue $m Actual CER
--------------
Crestor 1,050 (4%) 2% * Sales growth at CER driven by Emerging
Markets, offset by declines in the US
and Europe
Seloken 863 (9%) (4%) * Emerging Markets sales impacted by China
VBP implementation of Betaloc [49] oral
in H2 2021. Betaloc ZOK VBP was implemented
in Q4 2022
Onglyza 257 (28%) (25%) * Ongoing impact from VBP implementation
Bydureon 280 (27%) (26%) * Continued competitive pressures
Other CVRM 366 (10%) (7%)
--------------- ----- ------ ----- ---------------------------------------------
BioPharmaceuticals - R&I
Total Revenue of $5,963m from R&I medicines in FY 2022
decreased 1% (increased 3% at CER) and represented 13% of overall
Total Revenue (FY 2021: 16%). This reflected growth in recently
launched brands, including Fasenra, Tezspire, Breztri and Saphnelo,
offset by the erosion of Pulmicort revenue following its inclusion
in VBP in China in Q4 2021, and a smaller decline in Symbicort
revenue.
Symbicort
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- ---- ------ -----------
FY 2022 $m 2,538 608 973 582 375
Actual change (7%) - (9%) (13%) (2%)
CER change (2%) 5% (9%) (3%) 5%
--------------- --------- ---------------- ---- ------ -----------
Region Drivers and commentary
---------------- ------------------------------------------------------------
Worldwide * Symbicort remains the global market leader within
a stable ICS [50] /LABA [51] class
Emerging Markets * Growth driven primarily by Latin America, Middle East
and Asia Area, offset by decrease in China due to COVID-19
restrictions
US * Strong market share performance, consolidating leadership
in a declining ICS/LABA market, offset by pricing pressure
Europe * Resilient market share in growing ICS/LABA market,
offset by pricing pressure
Established * Growth in some countries driven by share gains and
RoW a continued recovery in the ICS/LABA market. That growth
was offset by generic erosion in other countries
---------------- ------------------------------------------------------------
Fasenra
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- --- ------ -----------
FY 2022 $m 1,396 43 906 305 142
Actual change 11% >2x 15% 7% (12%)
CER change 15% >2x 15% 20% (1%)
--------------- --------- ---------------- --- ------ -----------
Region Drivers and commentary
---------------- ---------------------------------------------------------------
Worldwide * Fasenra continues to be market leader in severe eosinophilic
asthma in major markets, and leading in the IL-5 [52]
class
Emerging Markets * Strong volume growth driven by launch acceleration
across key markets
US * Maintained a strong total patient share in the severe
asthma market
Europe * Sustained growth by expanding leadership in severe
eosinophilic asthma
Established * Maintained market leadership in Japan, partially offset
RoW 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 * Strong new-to-brand market share performance in Japan,
RoW with the dynamic market impacted by access restrictions
related to the rise in COVID-19 cases
---------------- ------------------------------------------------------------
Saphnelo
Total Revenue of $116m in the year (FY 2021: $8m) was driven by
demand acceleration in the US, where Saphnelo achieved new-to-brand
leadership in the i.v. [56] segment for SLE [57] and received a
permanent J-code facilitating reimbursement. Growth was further
supported by launches in Germany and Japan during the year.
Tezspire
Tezspire is approved in the US, EU and Japan (as well as other
countries) for the treatment of severe asthma without biomarker or
phenotypic limitation. Collaboration Revenue of $82m in the year
(FY 2021: $nil) reflected the strong early launch performance in
the US. In Europe and Established RoW, AstraZeneca recorded $4m
revenue ($2m in each region).
Amgen records sales in the US and AstraZeneca records its share
of gross profits in the US as Collaboration Revenue. Total ex-US
product sales are recorded as AstraZeneca revenue ($4m in 2022).
Global in-market sales of Tezspire were $174m in 2022.
Other R&I medicines
FY 2022 % Change
Total Revenue $m Actual CER
--------------- --- ------ ----- -----------------------------------------------
Pulmicort 645 (33%) (31%) * Emerging Markets revenue decreased 40%
(39% at CER) to $462m, impacted by VBP
implementation in China, lower rates of
hospitalisations and limited access to
nebulisation centres in China due to COVID-19
lockdowns
* Revenues in Ex-China Emerging Markets
grew following recovery of nebulisation
demand
Daliresp/Daxas 189 (17%) (16%) * Impacted by uptake of multiple generics
following loss of exclusivity in the US
* Total Revenue in the fourth quarter
decreased by 52%
Bevespi 58 7% 9%
Other R&I 540 (11%) (9%) * Collaboration Revenue of $119m (FY 2021:
$15m), including $110m of milestones relating
to tralokinumab (FY 2021: $nil)
* Product Sales of $421m decreased 29%
(27% at CER)
---------------- --- ------ ----- -----------------------------------------------
BioPharmaceuticals - V&I
Total Revenue from V&I medicines was broadly flat at $4,836m
(FY 2021: $4,779m) and represented 11% of overall Total Revenue (FY
2021: 13%).
Vaxzevria
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
-------------- --------- ---------------- --- ------ -----------
FY 2022 $m 1,875 805 79 365 625
Actual change (53%) (65%) 24% (65%) 8%
CER change (51%) (65%) 24% (61%) 17%
--------------- --------- ---------------- --- ------ -----------
Region Drivers and commentary
---------------- ----------------------------------------------------------------
Worldwide * Revenue in the fourth quarter decreased by 95% (94%
at CER) due to the conclusion of Vaxzevria contracts
Emerging Markets * $76m of Collaboration Revenue from sub-licensees in
FY 2022, including $46m in Q1 2022 from a Chinese sub-licensee
producing vaccines for export
* Revenue in the fourth quarter decreased by 95%
US * Purchases by the US Government for donation overseas
in Q1 2022
* No revenue was recorded after Q1 2022
Europe * Revenue in the fourth quarter decreased by 87% (84%
at CER) vs Q4 2021
Established * No revenue was recorded for Established RoW in the
RoW 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 * Approved in Japan for prevention and treatment of
RoW COVID-19 in August 2022
---------------- ---------------------------------------------------------
Other V&I medicines
FY 2022 % Change
Total Revenue $m Actual CER
-------------- --- ------ ----- -------------------------------------------
Synagis 578 41% 59% * Ex-US rights reverted to AstraZeneca
after 30 June 2021, from AbbVie Inc.
* In Q4 2022, Synagis sales decreased
by 19% (3% CER), reflecting the early
start to the RSV season in the prior year
period
* Late start to the influenza season in
FluMist 175 (31%) (20%) Europe
--------------- --- ------ ----- -------------------------------------------
Rare Disease
On a pro forma basis, Total Revenue from Rare Disease medicines
increased by 4% (10% at CER) in FY 2022 to $7,053m, representing
16% of overall Total Revenue.
Performance was driven by the durability of the C5 [58]
franchise, Soliris and Ultomiris growth in neurology indications,
Ultomiris gMG launch, and expansion into new markets.
Strensiq and Koselugo performances were driven by continued
patient demand and geographic expansion.
These tables show pro forma growth rates for each of the
medicines acquired with Alexion, calculated by comparing FY 2022
revenues with the medicine's revenues from 1 January 2021 to 31
December 2021.
Soliris
Total Revenue Worldwide Emerging Markets US Europe Established
RoW
----------------- --------- ---------------- ----- ------ -----------
FY 2022 $m 3,762 301 2,180 805 476
Actual 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 * Rapid conversion in new launch markets, strong growth
RoW in Japan following gMG launch
----------- -----------------------------------------------------------
Other Rare Disease medicines
FY 2022 % Change
Total Revenue $m Actual CER Commentary
-------------- --- ------ --- --------------------------------------------
* Performance driven by strong patient
Strensiq 958 16% 18% demand and geographic expansion
Koselugo 208 93% 96% * Growth driven by expansion in new markets
Kanuma 160 16% 19% * Continued demand growth in ex-US markets
--------------- --- ------ --- --------------------------------------------
Other medicines (outside the main therapy areas)
FY 2022 % Change
Total Revenue $m Actual CER Commentary
-------------- ----- ------ ---- -------------------------------------------
Nexium 1,367 (4%) 7% * Nexium (oral) was implemented in China's
VBP programme in February 2021 and Nexium
i.v. was implemented in October 2021
* Generic competition in Japan increased
in the fourth quarter
Others 381 (4%) (1%)
--------------- ----- ------ ---- -------------------------------------------
Financial performance
Table 9 : Reported Profit and Loss
FY 2022 FY 2021 % Change Q4 2022 Q4 2021 % Change
$m $m Actual CER $m $m Actual CER
------------------------ -------- -------- ------ ----- ------- ------- -------- ---------
Total Revenue 44,351 37,417 19 25 11,207 12,011 (7) 1
- Product Sales 42,998 36,541 18 24 10,798 11,498 (6) 2
- Collaboration Revenue 1,353 876 54 56 409 513 (20) (19)
------------------------- -------- -------- ------ ----- ------- ------- -------- ---------
Cost of sales (12,391) (12,437) - 4 (2,900) (4,625) (37) (35)
------------------------- -------- -------- ------ ----- ------- ------- -------- ---------
Gross profit 31,960 24,980 28 35 8,307 7,386 12 24
Gross Margin 71.2% 66.0% +5pp +5pp 73.1% 59.8% +13pp +15pp
------------------------- -------- -------- ------ ----- ------- ------- -------- ---------
Distribution expense (536) (446) 20 29 (156) (124) 26 38
% Total Revenue 1.2% 1.2% - - 1.4% 1.0% - -
R&D expense (9,762) (9,736) - 5 (2,625) (2,584) 2 9
% Total Revenue 22.0% 26.0% +4pp +4pp 23.4% 21.5% -2pp -2pp
SG&A expense (18,419) (15,234) 21 26 (4,621) (5,117) (10) (3)
% Total Revenue 41.5% 40.7% -1pp - 41.2% 42.6% +1pp +2pp
OOI [62] & expense 514 1,492 (66) (65) 189 147 29 33
% Total Revenue 1.2% 4.0% -3pp -3pp 1.7% 1.2% - -
------------------------- -------- -------- ------ ----- ------- ------- -------- ---------
Operating profit/(loss) 3,757 1,056 >3x >3x 1,094 (292) n/m n/m
Operating Margin 8.5% 2.8% 6 7 9.8% -2.4% +12pp +14pp
------------------------- -------- -------- ------ ----- ------- ------- -------- ---------
Net finance expense (1,251) (1,257) (1) 5 (315) (335) (6) -
Joint ventures and
associates (5) (64) (92) (91) (1) (9) (89) (89)
------------------------- -------- -------- ------ ----- ------- ------- -------- ---------
Profit/(loss) before
tax 2,501 (265) n/m n/m 778 (636) n/m n/m
------------------------- -------- -------- ------ ----- ------- ------- -------- ---------
Taxation 792 380 >2x >3x 124 290 (57) 21
Tax rate -32% 143% -16% 46%
------------------------- -------- -------- ------ ----- ------- ------- -------- ---------
Profit/(loss) after
tax 3,293 115 n/m n/m 902 (346) n/m n/m
------------------------- -------- -------- ------ ----- ------- ------- -------- ---------
Earnings per share $ 2.12 $0.08 n/m n/m $0.58 $(0.22) n/m n/m
------------------------- -------- -------- ------ ----- ------- ------- -------- ---------
Table 10 : Reconciliation of Reported Profit before tax to
EBITDA
FY 2022 FY 2021 % Change Q4 2022 Q4 2021 % Change
$m $m Actual CER $m $m Actual CER
--------------------------- ------- ------- ------ ---- ------- ------- ------ ----
Reported Profit/(loss)
before tax 2,501 (265) n/m n/m 778 (636) n/m n/m
Net finance expense 1,251 1,257 (1) 5 315 335 (6) -
Joint ventures and
associates 5 64 (92) (91) 1 9 (89) (89)
Depreciation, amortisation
and impairment 5,480 6,530 (16) (12) 1,480 2,192 (32) (28)
---------------------------- ------- ------- ------ ---- ------- ------- ------ ----
EBITDA 9,237 7,586 22 33 2,574 1,900 36 56
---------------------------- ------- ------- ------ ---- ------- ------- ------ ----
EBITDA of $9,237m in the year (FY 2021: $7,586m) has been
negatively impacted by the $3,484m (FY 2021: $2,198m) unwind of
inventory fair value uplift recognised on the acquisition of
Alexion. EBITDA of $2,574m in the quarter (Q4 2021: $1,900m) has
been negatively impacted by the $309m (Q4 2021: $1,154m) unwind of
inventory fair value uplift recognised on the acquisition of
Alexion. The unwind of the remaining $114m inventory fair value
uplift is expected to depress EBITDA in 2023.
Table 11 : Reconciliation of Reported to Core financial
measures: FY 2022
FY 2022 Reported Restructuring Intangible Acquisition Other Core Core
Asset Amortisation of Alexion % Change
& Impairments
$m $m $m $m $m $m Actual CER
------------------ -------- ----- ----- ----- -------- -------- ------ ----
Gross profit 31,960 266 32 3,506 (1) 35,763 28 35
Gross Margin 71.2% 80.0% +6pp +6pp
------------------- -------- ----- ----- ----- -------- -------- ------ ----
Distribution
expense (536) 2 - - - (534) 20 28
R&D expense (9,762) 111 124 27 - (9,500) 19 24
SG&A expense (18,419) 405 4,165 38 985 [63] (12,826) 15 21
------------------- -------- ----- ----- ----- -------- -------- ------ ----
Total operating
expense (28,717) 518 4,289 65 985 (22,860) 17 23
------------------- -------- ----- ----- ----- -------- -------- ------ ----
Other operating
income & expense 514 (67) - - - 447 (70) (69)
------------------- -------- ----- ----- ----- -------- -------- ------ ----
Operating
profit 3,757 717 4,321 3,571 984 13,350 34 42
Operating
Margin 8.5% 30.1% +4pp +4pp
------------------- -------- ----- ----- ----- -------- -------- ------ ----
Net finance
expense (1,251) - - - 277 (974) 13 18
(1,049)
Taxation 792 (165) (804) (832) [64] (2,058) 38 46
------------------- -------- ----- ----- ----- -------- -------- ------ ----
EPS $2.12 $0.36 $2.27 $1.77 $0.14 $6.66 26 33
------------------- -------- ----- ----- ----- -------- -------- ------ ----
Table 12 : Reconciliation of Reported to Core financial
measures: Q4 2022
Q4 2022 Reported Restructuring Intangible Acquisition Other Core Core
Asset Amortisation of Alexion % Change
& Impairments
$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)
------------------- ------- ----- ----- ----- ------ ------- ------ ----
($0.07
EPS $0.58 $0.11 $0.60 $0.16 ) $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 At 31
Dec 2022 Dec 2021
$m $m
--------------------------------------------------- --------- ---------
Cash and cash equivalents 6,166 6,329
Other investments 239 69
---------------------------------------------------- --------- ---------
Cash and investments 6,405 6,3 98
---------------------------------------------------- --------- ---------
Overdrafts and short-term borrowings (350) (387 )
Lease liabilities (953) (987 )
Current instalments of loans (4,964) (1,273 )
Non-current instalments of loans (22,965) (28,134 )
---------------------------------------------------- --------- ---------
Interest-bearing loans and borrowings (Gross Debt) (29,232 ) (30,781)
---------------------------------------------------- --------- ---------
Net derivatives (96) 61
---------------------------------------------------- --------- ---------
Net Debt (22,923 ) (24,322 )
---------------------------------------------------- --------- ---------
Net Debt decreased by $1,399m in the year to $22,923m. Details
of the committed undrawn bank facilities are disclosed within the
going concern section of Note 1. Details of the Company's solicited
credit ratings are disclosed in Note 3.
Capital allocation
The Board's aim is to continue to strike a balance between the
interests of the business, financial creditors and the Company's
shareholders. The Company's capital allocation priorities include:
investing in the business and pipeline; maintaining a strong,
investment-grade credit rating; potential value-enhancing business
development opportunities; and supporting the progressive dividend
policy.
In approving the declaration of dividends, the Board considers
both the liquidity of the company and the level of reserves legally
available for distribution. Dividends are paid to shareholders from
AstraZeneca PLC, a Group holding company with no direct operations.
The ability of AstraZeneca PLC to make shareholder distributions is
dependent on the creation of profits for distribution and the
receipt of funds from subsidiary companies. The consolidated Group
reserves set out in the Condensed consolidated statement of
financial position do not reflect the profit available for
distribution to the shareholders of AstraZeneca PLC.
Summarised financial information for guarantee of securities of
subsidiaries
AstraZeneca Finance LLC ("AstraZeneca Finance") is the issuer of
0.700% Notes due 2024, 1.200% Notes due 2026, 1.750% Notes due 2028
and 2.250% Notes due 2031 (the "AstraZeneca Finance Notes"). Each
series of AstraZeneca Finance Notes has been fully and
unconditionally guaranteed by AstraZeneca PLC. AstraZeneca Finance
is 100% owned by AstraZeneca PLC and each of the guarantees by
AstraZeneca PLC is full and unconditional and joint and
several.
The AstraZeneca Finance Notes are senior unsecured obligations
of AstraZeneca Finance and rank equally with all of AstraZeneca
Finance's existing and future senior unsecured and unsubordinated
indebtedness. The guarantee by AstraZeneca PLC of the AstraZeneca
Finance Notes is the senior unsecured obligation of AstraZeneca PLC
and ranks equally with all of AstraZeneca PLC's existing and future
senior unsecured and unsubordinated indebtedness. Each guarantee by
AstraZeneca PLC is effectively subordinated to any secured
indebtedness of AstraZeneca PLC to the extent of the value of the
assets securing such indebtedness. The AstraZeneca Finance Notes
are structurally subordinated to indebtedness and other liabilities
of the subsidiaries of AstraZeneca PLC, none of which guarantee the
AstraZeneca Finance Notes.
AstraZeneca PLC manages substantially all of its operations
through divisions, branches and/or investments in subsidiaries and
affiliates. Accordingly, the ability of AstraZeneca PLC to service
its debt and guarantee obligations is also dependent upon the
earnings of its subsidiaries, affiliates, branches and divisions,
whether by dividends, distributions, loans or otherwise.
Please refer to the consolidated financial statements of
AstraZeneca PLC in our Annual Report on Form 20-F and reports on
Form 6-K with our quarterly financial results as filed or furnished
with the SEC [65] for further financial information regarding
AstraZeneca PLC and its consolidated subsidiaries. For further
details, terms and conditions of the AstraZeneca Finance Notes
please refer to AstraZeneca PLC's Form 6-K furnished to the SEC on
28 May 2021.
Pursuant to Rule 13-01 and Rule 3-10 of Regulation S-X under the
Securities Act of 1933, as amended (the "Securities Act"), we
present below the summary financial information for AstraZeneca
PLC, as Guarantor, excluding its consolidated subsidiaries, and
AstraZeneca Finance, as the issuer, excluding its consolidated
subsidiaries. The following summary financial information of
AstraZeneca PLC and AstraZeneca Finance is presented on a combined
basis and transactions between the combining entities have been
eliminated. Financial information for non-guarantor entities has
been excluded. Intercompany balances and transactions between the
obligor group and the non-obligor subsidiaries are presented on
separate lines.
Table 15 : Obligor group summarised Statement of comprehensive
income
FY 2022
$m
------------------------------------------------------------------ -------
Total Revenue -
Gross Profit -
Operating loss (27)
Loss for the period (687)
Transactions with subsidiaries that are not issuers or guarantors 1,071
------------------------------------------------------------------- -------
Table 16 : Obligor group summarised Statement of financial
position
At 31 Dec 2022
$m
----------------------------------------------------------------- --------------
Current assets 4
Non-current assets -
Current liabilities (2,839)
Non-current liabilities (22,797)
Amounts due from subsidiaries that are not issuers or guarantors 7,806
Amounts due to subsidiaries that are not issuers or guarantors (293)
------------------------------------------------------------------ --------------
Foreign exchange
The Company's transactional currency exposures on
working-capital balances, which typically extend for up to three
months, are hedged where practicable using forward foreign exchange
contracts against the individual companies' reporting currency.
Foreign exchange gains and losses on forward contracts for
transactional hedging are taken to profit or loss. In addition, the
Company's external dividend payments, paid principally in pounds
sterling and Swedish krona, are fully hedged from announcement to
payment date.
Table 17 : Currency sensitivities
The Company provides the following currency-sensitivity
information:
Average spot Annual impact of 5% strengthening in
rates vs. USD FY average rate vs. USD ($m) ([66])
-------------- ------------------------------------
Currency Primary Relevance FY Jan Change Total Revenue Core Operating Profit
2022 [67] 2023 [68] (%)
EUR Total Revenue 0.95 0.93 2 323 159
CNY Total Revenue 6.74 6.79 (1) 309 174
JPY Total Revenue 131.59 130.37 1 181 122
Other ([69]) 385 202
---------------------------------- ---------- ---------- ------ ------------- ---------------------
GBP Operating expense 0.81 0.82 (1) 46 (92)
SEK Operating expense 10.12 10.39 (3) 7 (55)
Sustainability
Since the last quarterly report, AstraZeneca:
Access to healthcare
-- Presented the main findings of health system research
conducted by the Partnership for Health System Sustainability and
Resilience (PHSSR), which the Company co-founded, at the second
Global PHSSR Summit in November. The results highlighted key themes
across workforce and health service delivery, finance and
governance, and the role of technology in strengthening health
systems, as well as the importance of prevention and early
intervention in non-communicable diseases
-- Achieved third position overall in the 2022 Access to
Medicine Index and was recognised as the industry leader in Product
Delivery, including for its application of tailored access
strategies for countries reflecting their income classifications
across all product categories. The Company's approach to patent
transparency and sharing of intellectual property assets, using
technology transfers, was also highlighted as key to ensuring
continuous supply of medicines in low- and middle-income countries.
It also performed well in the Governance of Access and Research
& Development categories
-- Chair Leif Johansson alongside Senior Executive Team members
Marc Dunoyer, Dave Fredrickson and Iskra Reic attended the World
Economic Forum (WEF) in Davos in January 2023, for engagements with
global, regional and national leaders. The Company focused on
investing in health as the foundation of strong and resilient
societies, and the need for collective early action to build more
sustainable and equitable healthcare systems, including through
collaborations such as the PHSSR and Sustainable Markets Initiative
(SMI). AstraZeneca hosted a high-level roundtable on investing in
non-communicable diseases attended by global health leaders, and
signed the Zero Health Gaps Pledge in support of the WEF Global
Health Equity Network vision to advance health equity
-- Committed to expand the Healthy Heart Africa programme into
10 countries over two years, starting in 2023, in addition to the
nine countries where the programme is currently active. Over 32
million blood pressure screenings have been conducted since launch
in 2015 and over 10,600 healthcare workers trained, as at end of
December 2022
-- Reached more than nine million young people through the Young
Health Programme with health information and trained more than
260,000 young people as peer educators in 39 countries, by end of
December 2022
Environmental protection
-- CEO Pascal Soriot hosted a high-level engagement on climate
and health at COP27, in his capacity as champion of the SMI Health
Systems Task Force, which made sector-first commitments, actions
and recommendations to deliver near-term targets and support the
transition to net-zero sustainable healthcare. The Company also
launched new commitments during COP27 in support of its Ambition
Zero Carbon strategy
-- Achieved a double-A rating for Climate Change and Water
Security from CDP for the seventh consecutive year, and an improved
Forest score of B for timber, B for palm oil and C for cattle
products. AstraZeneca received a CDP UK Leadership Award in
recognition of the double-A rating and commitment to environmental
transparency. AZ Forest has also published a pledge implementation
update report
-- Achieved a 100% electric vehicle fleet in the Netherlands,
the first Company location to do so, as part of the fleet
decarbonisation strategy to support Ambition Zero Carbon emissions
reduction targets
-- Earned the US Environmental Protection Agency's ENERGY
STAR(R) 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 US Tagrisso in combination with savolitinib for
Designation the treatment of patients with locally advanced
or metastatic NSCLC whose tumours have MET overexpression
and/or amplification, as detected by an FDA-approved
test, and who have had disease progression during
or following prior Tagrisso.
------------ ----------------------------------------------------------
Imfinzi and Imjudo (tremelimumab)
Event Commentary
-------- ----------- ------------------------------------------------------
Approval US Imfinzi in combination with Imjudo plus platinum-based
chemotherapy for the treatment of adult patients
with Stage IV NSCLC with no sensitising EGFR
[70] mutations or anaplastic lymphoma kinase.
(POSEIDON, November 2022)
Approval EU Imfinzi for the 1st-line treatment of adult
patients with unresectable or metastatic BTC
in combination with chemotherapy. (TOPAZ-1, December
2022)
Approval JP Imfinzi with or without Imjudo for the treatment
of adult patients with unresectable HCC. (HIMALAYA,
December 2022)
Imfinzi for the treatment of adult patients
with curatively unresectable BTC in combination
with chemotherapy. (TOPAZ-1, December 2022 )
Imfinzi for the treatment of adult patients
with unresectable, advanced or recurrent NSCLC
in combination with chemotherapy. (POSEIDON,
December 2022)
Read-out PEARL Phase The PEARL Phase III trial for Imfinzi did not
III trial achieve statistical significance for the primary
endpoints of improving overall survival versus
platinum-based chemotherapy as a monotherapy
for the treatment of patients with Stage IV NSCLC
whose tumour cells express high levels (25% or
more) of PD-L1 [71] , or in a subgroup of patients
at low risk of early mortality. (December 2022)
-------- ----------- ------------------------------------------------------
Lynparza
Event Commentary
------------ ---------------------------------------------------
Approval EU Lynparza in combination with abiraterone for
the treatment of mCRPC in adult men for whom
chemotherapy is not clinically indicated. (PROpel,
December 2022)
PDUFA [72] US The FDA indicated it will extend the PDUFA date
date change by three months to March 2023 in order to provide
further time for a full review of the sNDA [73]
for Lynparza in combination with abiraterone
for the treatment of mCRPC. (PROpel, December
2022)
------------ ---------------------------------------------------
Calquence
Event Commentary
------------- -------------- ------------------------------------------------
Presentation: Real-world Real-world evidence and long-term follow-up data
ASH evidence support consistent efficacy and safety profile
and long-term of Calquence.
follow-up
data
Approval JP Calquence for the treatment of adult patients
with treatment-naïve chronic lymphocytic
leukaemia (ELEVATE-TN)
CHMP positive EU Maleate tablet formulation
opinion
------------- -------------- ------------------------------------------------
Enhertu
Event Commentary
------------- ---------------- -------------------------------------------------------
Presentation: DESTINY-Breast03 Updated OS [74] results from the DESTINY-Breast03
SABCS Phase III Phase III trial, presented at SABCS 2022, demonstrated
trial Enhertu statistically significant and clinically
meaningful improvement in OS compared to T-DM1
[75] in patients with HER2--positive unresectable
and/or metastatic breast cancer.
DESTINY-Breast02 Primary results from the DESTINY-Breast02 Phase
Phase III III trial demonstrated clinical benefit of Enhertu
trial 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: TROPION-PanTumor01 Initial results from the TROPION-PanTumor01 Phase
SABCS Phase I trial I trial showed encouraging and durable efficacy
of Dato--DXd in patients with heavily pre-treated
HR-positive, HER2-low or HER2-negative unresectable
or metastatic breast cancer. In this cohort,
Dato-DXd demonstrated an objective response rate
of 27% as assessed by blinded independent central
review. All responses were partial and 56% of
patients achieved stable disease. The disease
control rate was 85% and median PFS was 8.3 months.
Updated results from the TROPION-PanTumor01 Phase
I trial demonstrated Dato--DXd continued to demonstrate
encouraging responses in patients with heavily
pretreated metastatic TNBC and disease progression
following standard treatment.
In the TNBC cohort, Dato--DXd demonstrated an
ORR [76] of 32% including one complete response,
13 partial responses and 18 cases of stable disease
as assessed by blinded independent central review.
In the overall cohort, Dato--DXd demonstrated
median PFS of 4.4 months and median OS of 13.5
months. (December 2022)
------------- ------------------ --------------------------------------------------------
Camizestrant
Event Commentary
Presentation: SERENA-2 Detailed results from the SERENA-2 Phase II trial
SABCS Phase II of camizestrant, AstraZeneca's next-generation
trial 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: CAPItello-291 Detailed results from the CAPItello-291 Phase
SABCS Phase III III trial of capivasertib in combination with
trial Faslodex demonstrated a statistically significant
and clinically meaningful improvement in PFS
versus placebo plus Faslodex in patients with
HR-positive, HER2-low or negative, locally advanced
or metastatic breast cancer following recurrence
or progression on, or after, endocrine therapy
(with or without a CDK4/6 inhibitor).
Capivasertib in combination with Faslodex demonstrated
a 40% reduction in the risk of disease progression
or death versus placebo plus Faslodex in the
overall trial population (based on a HR of 0.60,
95% confidence interval) and median PFS 7.2 versus
3.6 months. In the AKT pathway biomarker-altered
population, which affects up to 50% of patients
with advanced HR-positive breast cancer, capivasertib
plus Faslodex reduced risk of disease progression
or death by 50% versus placebo plus Faslodex.
------------- ------------- -------------------------------------------------------
BioPharmaceuticals - CVRM
Farxiga
Event Commentary
-------- ----------------------------------------------------
Approval EU Forxiga for heart failure with reduced ejection
fraction to cover patients across the full spectrum
of left ventricular ejection fraction including
heart failure with mildly reduced and preserved
ejection fraction. (DELIVER, February 2023)
-------- ----------------------------------------------------
BioPharmaceuticals - R&I
Significant new trials in R&I initiated since the previous
results included:
-- TILIA, a Phase III trial for tozorakimab in acute respiratory
failure in patients with viral lung infection
Tezspire
Event Commentary
-------- ------ ------------------------------------------------------
Approval US, EU The Tezspire pre-filled pen for self-administration
in a pre-filled, single-use pen for patients
aged 12 years and older with severe asthma. (January,
February 2023)
-------- ------ ------------------------------------------------------
Airsupra (PT027)
Event Commentary
-------- --------------------------------------------------
Approval US Airsupra for the as-needed treatment or prevention
of bronchoconstriction and to reduce the risk
of exacerbations in people with asthma aged 18
years and older. This is the first approval for
Airsupra, formerly known as PT027. (January 2023)
-------- --------------------------------------------------
Saphnelo
Event Commentary
------------ ----------------------------------------------------
Orphan Drug US Saphnelo for idiopathic inflammatory myopathies
Designation (including myositis), a group of diseases in
which type I interferon plays a key role. (December
2022)
------------ ----------------------------------------------------
Fasenra
Event Commentary
------------------- ------ --------------------------------------------------
Phase III HUDSON Eosinophilic gastritis (EG/EGE) trial discontinued
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 US Tozorakimab to reduce the risk of invasive mechanical
Designation 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 US The FDA has revised Evusheld's Emergency Use
to Emergency Authorisation to limit the use of Evusheld to
Use Authorisation when the combined frequency of non-susceptible
SARS-CoV-2 variants nationally in the US is <=90%.
(January 2023)
Evusheld is not currently authorised by the
US FDA for pre-exposure prophylaxis of COVID-19
(as of January 2023), due to sustained high frequency
of circulating SARS-CoV-2 variants against which
Evusheld does not retain in vitro neutralisation.
------------------ ------------------------------------------------------
Beyfortus
Event Commentary
----------- ---------------------------------------------------
Regulatory US Nirsevimab for prevention of lower respiratory
submission 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: PNH monotherapy An oral presentation detailing interim results
ASH Phase II from a Phase II open-label trial of vemircopan
trial (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.
----------- --------------- ------------------------------------------------------
Condensed Consolidated Financial Statements
Table 18 : Condensed consolidated statement of comprehensive
income: FY 2022
For the year ended 31 December 2022 2021
$m $m
-------- --------
Total Revenue 44,351 37,417
Product Sales 42,998 36,541
Collaboration Revenue 1,353 876
-------------------------------------------------------------------------------------------- -------- --------
Cost of sales (12,391) (12,437)
-------------------------------------------------------------------------------------------- -------- --------
Gross profit 31,960 24,980
-------------------------------------------------------------------------------------------- -------- --------
Distribution expense (536) (446)
Research and development expense (9,762) (9,736)
Selling, general and administrative expense (18,419) (15,234)
Other operating income and expense 514 1,492
-------------------------------------------------------------------------------------------- -------- --------
Operating profit 3,757 1,056
-------------------------------------------------------------------------------------------- -------- --------
Finance income 95 43
Finance expense (1,346) (1,300)
Share of after tax losses in associates and joint ventures (5) (64)
-------------------------------------------------------------------------------------------- -------- --------
Profit/(loss) before tax 2,501 (265)
-------------------------------------------------------------------------------------------- -------- --------
Taxation 792 380
-------------------------------------------------------------------------------------------- -------- --------
Profit for the period 3,293 115
-------------------------------------------------------------------------------------------- -------- --------
Other comprehensive income
-------------------------------------------------------------------------------------------- -------- --------
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability 1,118 626
Net losses on equity investments measured at fair value through other comprehensive income (88) (187)
Fair value movements related to own credit risk on bonds designated as fair value through
profit or loss 2 -
Tax on items that will not be reclassified to profit or loss (216) 105
-------------------------------------------------------------------------------------------- -------- --------
816 544
-------- --------
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation (1,446) (483)
Foreign exchange arising on designated liabilities in net investment hedges (282) (321)
Fair value movements on cash flow hedges (97) (167)
Fair value movements on cash flow hedges transferred to profit and loss 73 208
Fair value movements on derivatives designated in net investment hedges (8) 34
Costs of hedging (7) (6)
Tax on items that may be reclassified subsequently to profit or loss 73 46
-------------------------------------------------------------------------------------------- -------- --------
(1,694) (689)
-------- --------
Other comprehensive loss, net of tax (878 ) (145)
-------------------------------------------------------------------------------------------- -------- --------
Total comprehensive income/(loss) for the period 2,415 (30)
-------------------------------------------------------------------------------------------- -------- --------
Profit attributable to:
-------------------------------------------------------------------------------------------- -------- --------
Owners of the Parent 3,288 112
Non-controlling interests 5 3
-------------------------------------------------------------------------------------------- -------- --------
3,293 115
-------- --------
Total comprehensive income/(loss) attributable to:
-------------------------------------------------------------------------------------------- -------- --------
Owners of the Parent 2,413 (33)
Non-controlling interests 2 3
-------------------------------------------------------------------------------------------- -------- --------
2,415 (30)
-------- --------
Basic earnings per $0.25 Ordinary Share $2.12 $0.08
Diluted earnings per $0.25 Ordinary Share $2.11 $0.08
Weighted average number of Ordinary Shares in issue (millions) 1,548 1,418
Diluted weighted average number of Ordinary Shares in issue (millions) 1,560 1,427
-------------------------------------------------------------------------------------------- -------- --------
Table 19 : Condensed consolidated statement of comprehensive
income: Q4 2022
For the quarter ended 31 December 2022 2021
$m $m
------- -------
Total Revenue 11,207 12,011
Product Sales 10,798 11,498
Collaboration Revenue 409 513
-------------------------------------------------------------------------------------------- ------- -------
Cost of sales (2,900) (4,625)
-------------------------------------------------------------------------------------------- ------- -------
Gross profit 8,307 7,386
-------------------------------------------------------------------------------------------- ------- -------
Distribution expense (156) (124)
Research and development expense (2,625) (2,584)
Selling, general and administrative expense (4,621) (5,117)
Other operating income and expense 189 147
-------------------------------------------------------------------------------------------- ------- -------
Operating profit/(loss) 1,094 (292)
-------------------------------------------------------------------------------------------- ------- -------
Finance income 45 1
Finance expense (360) (336)
Share of after tax losses in associates and joint ventures (1) (9)
-------------------------------------------------------------------------------------------- ------- -------
Profit/(loss) before tax 778 (636)
-------------------------------------------------------------------------------------------- ------- -------
Taxation 124 290
-------------------------------------------------------------------------------------------- ------- -------
Profit/(loss) for the period 902 (346)
-------------------------------------------------------------------------------------------- ------- -------
Other comprehensive income
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability (165) 34
Net losses on equity investments measured at fair value through other comprehensive income (67) (331)
Fair value movements related to own credit risk on bonds designated as fair value through
profit or loss 1 (4)
Tax on items that will not be reclassified to profit or loss 75 34
-------------------------------------------------------------------------------------------- ------- -------
(156) (267)
------- -------
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation 1,047 (115)
Foreign exchange arising on designated liabilities in net investment hedges 39 (46)
Fair value movements on cash flow hedges 117 (64)
Fair value movements on cash flow hedges transferred to profit and loss (177) 71
Fair value movements on derivatives designated in net investment hedges (41) 12
Costs of hedging 4 -
Tax on items that may be reclassified subsequently to profit or loss (22) 9
-------------------------------------------------------------------------------------------- ------- -------
967 (133)
------- -------
Other comprehensive income/(loss), net of tax 811 (400)
-------------------------------------------------------------------------------------------- ------- -------
Total comprehensive income/(loss) for the period 1,713 (746)
-------------------------------------------------------------------------------------------- ------- -------
Profit/(loss) attributable to:
-------------------------------------------------------------------------------------------- ------- -------
Owners of the Parent 901 (347)
Non-controlling interests 1 1
-------------------------------------------------------------------------------------------- ------- -------
902 (346)
------- -------
Total comprehensive income/(loss) attributable to:
-------------------------------------------------------------------------------------------- ------- -------
Owners of the Parent 1,712 (747)
Non-controlling interests 1 1
-------------------------------------------------------------------------------------------- ------- -------
1,713 (746)
------- -------
Basic earnings per $0.25 Ordinary Share $0.58 $(0.22)
Diluted earnings per $0.25 Ordinary Share $0.58 $(0.22)
Weighted average number of Ordinary Shares in issue (millions) 1,549 1,547
Diluted weighted average number of Ordinary Shares in issue (millions) 1,559 1,547
-------------------------------------------------------------------------------------------- ------- -------
Table 20 : Condensed consolidated statement of financial
position
At 31 Dec At 31 Dec
2022 2021
$m $m
------------------------------------------------------------------ --------- ---------
Assets
Non-current assets
Property, plant and equipment 8,507 9,183
Right-of-use assets 942 988
Goodwill 19,820 19,997
Intangible assets 39,307 42,387
Investments in associates and joint ventures 76 69
Other investments 1,066 1,168
Derivative financial instruments 74 102
Other receivables 835 895
Deferred tax assets 3,263 4,330
------------------------------------------------------------------- --------- ---------
73,890 79,119
--------- ---------
Current assets
Inventories 4,699 8,983
Trade and other receivables 10,521 9,644
Other investments 239 69
Derivative financial instruments 87 83
Intangible assets - 105
Income tax receivable 731 663
Cash and cash equivalents 6,166 6,329
Assets held for sale 150 368
------------------------------------------------------------------- --------- ---------
22,593 26,244
--------- ---------
Total assets 96,483 105,363
------------------------------------------------------------------- --------- ---------
Liabilities
Current liabilities
Interest-bearing loans and borrowings (5,314) (1,660)
Lease liabilities (228) (233)
Trade and other payables (19,040) (18,938)
Derivative financial instruments (93) (79)
Provisions (722) (768)
Income tax payable (896) (916)
------------------------------------------------------------------- --------- ---------
(26,293 ) (22,594)
--------- ---------
Non-current liabilities
Interest-bearing loans and borrowings (22,965) (28,134)
Lease liabilities (725) (754)
Derivative financial instruments (164) (45)
Deferred tax liabilities (2,944) (6,206)
Retirement benefit obligations (1,168) (2,454)
Provisions (896) (956)
Other payables (4,270) (4,933)
------------------------------------------------------------------- --------- ---------
(33,132 ) (43,482)
--------- ---------
Total liabilities (59,425 ) (66,076)
------------------------------------------------------------------- --------- ---------
Net assets 37,058 39,287
------------------------------------------------------------------- --------- ---------
Equity
Capital and reserves attributable to equity holders of the Parent
Share capital 387 387
Share premium account 35,155 35,126
Other reserves 2,069 2,045
Retained earnings (574) 1,710
------------------------------------------------------------------- --------- ---------
37,037 39,268
Non-controlling interests 21 19
------------------------------------------------------------------- --------- ---------
Total equity 37,058 39,287
------------------------------------------------------------------- --------- ---------
Table 21 : Condensed consolidated statement of changes in
equity
Share Share Other Retained Total Non-controlling Total
capital premium reserves earnings attributable interests equity
account to owners
of the
parent
$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)
------------------------ -------- -------- --------- --------- ------------- --------------- -------
(574
At 31 Dec 2022 387 35,155 2,069 ) 37,037 21 37,058
------------------------ -------- -------- --------- --------- ------------- --------------- -------
Table 22 : Condensed consolidated statement of cash flows
For the year ended 31 December 2022 2021
$m $m
Cash flows from operating activities
Profit/(loss) before tax 2,501 (265)
Finance income and expense 1,251 1,257
Share of after tax losses of associates and
joint ventures 5 64
Depreciation, amortisation and impairment 5,480 6,530
Increase in trade and other receivables (1,349) (961)
Decrease in inventories 3,941 1,577
Increase in trade and other payables and provisions 1,165 1,405
Gains on disposal of intangible assets (104) (513)
Gains on disposal of investments in associates
and joint ventures - (776)
Fair value movements on contingent consideration
arising from business combinations 82 14
Non-cash and other movements (692) 95
------------------------------------------------------ -------- --------
Cash generated from operations 12,280 8,427
------------------------------------------------------ -------- --------
Interest paid (849) (721)
Tax paid (1,623) (1,743)
------------------------------------------------------ -------- --------
Net cash inflow from operating activities 9,808 5,963
------------------------------------------------------ -------- --------
Cash flows from investing activities
Acquisition of subsidiaries, net of cash acquired (48) (9,263)
Payments upon vesting of employee share awards
attributable to business combinations (215) (211)
Payment of contingent consideration from business
combinations (772) (643)
Purchase of property, plant and equipment (1,091) (1,091)
Disposal of property, plant and equipment 282 13
Purchase of intangible assets (1,480) (1,109)
Disposal of intangible assets and assets held
for sale 447 587
Movement in profit-participation liability - 20
Purchase of non-current asset investments (45) (184)
Disposal of non-current asset investments 42 9
Movement in short-term investments, fixed deposits
and other investing instruments (114) 96
Payments to associates and joint ventures (26) (92)
Disposal of investments in associates and joint
ventures - 776
Interest received 60 34
------------------------------------------------------ -------- --------
(2,960
Net cash outflow from investing activities ) (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) -
------------------------------------------------------ -------- --------
(6,823
Net cash (outflow)/inflow from financing activities ) 3,649
------------------------------------------------------ -------- --------
Net increase/(decrease) in Cash and cash equivalents
in the period 25 (1,446)
Cash and cash equivalents at the beginning of
the period 6,038 7,546
Exchange rate effects (80) (62)
------------------------------------------------------ -------- --------
Cash and cash equivalents at the end of the
period 5,983 6,038
------------------------------------------------------ -------- --------
Cash and cash equivalents consist of:
Cash and cash equivalents 6,166 6,329
Overdrafts (183) (291)
------------------------------------------------------ -------- --------
5,983 6,038
-------- --------
Notes to the Condensed Consolidated Financial Statements
Note 1: Basis of preparation and accounting policies
The Condensed Consolidated Financial Statements for the year
ended 31 December 2022 have been prepared in accordance with
UK-adopted International Accounting Standards and with the
requirements of the Companies Act 2006 as applicable to companies
reporting under those standards. The Condensed Consolidated
Financial Statements also comply fully with International Financial
Reporting Standards (IFRSs) as issued by the International
Accounting Standards Board (IASB) and International Accounting
Standards as adopted by the European Union.
The Condensed Consolidated Financial Statements for the year
ended 31 December 2022 include Alexion's results for the period.
Alexion's post-acquisition results for 2021 were consolidated into
the Group's results from 21 July 2021 therefore the respective
comparative periods shown are not entirely comparable with the
current period.
These Condensed Consolidated Financial Statements comprise the
financial results of AstraZeneca PLC for the years to 31 December
2022 and 2021 together with the Statement of financial position as
at 31 December 2022 and 2021. The results for the year to 31
December 2022 have been extracted from the 31 December 2022 audited
Consolidated Financial Statements which have been approved by the
Board of Directors. These have not yet been delivered to the
Registrar of Companies but are expected to be published on 21
February 2023 within the Annual Report and Form 20-F Information
2022.
The financial information set out above does not constitute the
Group's statutory accounts for the years to 31 December 2022 or
2021 but is derived from those accounts. The auditors have reported
on those accounts: their reports (i) were unqualified, (ii) did not
include a reference to any matters to which the auditors drew
attention by way of emphasis without qualifying their report and
(iii) did not contain a statement under section 498 (2) or (3) of
the Companies Act 2006 in respect of the accounts for the year to
31 December 2022 or 31 December 2021. Statutory accounts for the
year to 31 December 2022 were approved by the Board of Directors
for release on 9 February 2023.
The Condensed Consolidated Financial Statements have been
prepared applying the accounting policies that were applied in the
preparation of the Group's published consolidated financial
statements for the year ended 31 December 2021.
AstraZeneca has assessed the impact of the uncertainty presented
by the COVID-19 pandemic and the Russia-Ukraine conflict on the
Financial Statements, specifically considering the impact on key
judgements and significant estimates along with several other areas
of increased risk. No material accounting impacts relating to
COVID-19 or the Russia-Ukraine conflict were recognised in the
year.
Going concern
The Group has considerable financial resources available. As at
31 December 2022, the Group has $11.1bn in financial resources
(Cash and cash equivalent balances of $6.2bn and undrawn committed
bank facilities of $4.9bn available until April 2026 with only
$5.5bn of borrowings due within one year). All facilities contain
no financial covenants and were undrawn at 31 December 2022. On 2
February 2023, the Group entered into an additional $2.0bn of
two-year committed bank facilities.
The Group's revenues are largely derived from sales of medicines
covered by patents. which provide a relatively high level of
resilience and predictability to cash inflows, although government
price interventions in response to budgetary constraints are
expected to continue to adversely affect revenues in some of our
significant markets. The Group, however, anticipates new revenue
streams from both recently launched medicines and those in
development, and the Group has a wide diversity of customers and
suppliers across different geographic areas.
Consequently, the Directors believe that, overall, the Group is
well placed to manage its business risks successfully. Accordingly,
they continue to adopt the going concern basis in preparing the
Condensed Consolidated Financial Statements.
Legal proceedings
The information contained in Note 6 updates the disclosures
concerning legal proceedings and contingent liabilities in the
Group's Annual Report and Form 20-F Information 2021 .
Note 2: Intangible assets
In accordance with IAS 36 'Impairment of Assets', reviews for
triggers of impairment or impairment reversals at an individual
asset or cash generating unit level were conducted, and impairment
tests carried out where triggers were identified. As a result,
total net impairment charges of $224m have been recorded against
intangible assets during the year ended 31 December 2022 (FY 2021:
$2,085m net charge). Net impairment charges in respect of medicines
in development and launched medicines were $95m (FY 2021: $1,464m)
and $146m (FY 2021: $603m charge) respectively.
Note 3: Net Debt
The table below provides an analysis of Net Debt and a
reconciliation of Net Cash Flow to the movement in Net Debt. The
Group monitors Net Debt as part of its capital-management policy as
described in Note 28 of the Annual Report and Form 20-F Information
2021 . Net Debt is a non-GAAP financial measure.
Table 23 : Net Debt
At 1 Jan 2022 Cash flow Acquisitions Non-cash Exchange movements At 31 Dec 2022
& other
$m $m $m $m $m $m
----------------------------- ------------- --------- ------------ -------- ------------------ --------------
Non-current instalments of
loans (28,134) - (2) 4,957 214 (22,965)
Non-current instalments of
leases (754) - (3) (2) 34 (725)
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Total long-term debt (28,888) - (5) 4,955 248 (23,690 )
Current instalments of loans (1,273) 1,271 (3) (4,959) - (4,964)
Current instalments of leases (233) 253 (1) (260) 13 (228)
Bank collateral received (93) 4 - - - (89)
Other short-term borrowings
excluding overdrafts (3) (78) - - 3 (78)
Overdrafts (291) 85 - - 23 (183)
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Total current debt (1,893) 1,535 (4) (5,219 ) 39 (5,542 )
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Gross borrowings (30,781) 1,535 (9) (264) 287 (29,232 )
Net derivative financial
instruments 61 73 - (230) - (96)
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Net borrowings (30,720) 1,608 (9) (494 ) 287 (29,328 )
Cash and cash equivalents 6,329 (72) 12 - (103) 6,166
Other investments - current 69 168 8 - (6) 239
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Cash and investments 6,398 96 20 - (109 ) 6,405
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Net Debt (24,322) 1,704 11 (494) 178 (22,923)
------------------------------ ------------- --------- ------------ -------- ------------------ --------------
Non-cash movements in the period include fair value adjustments
under IFRS 9 Financial Instruments.
The Group has agreements with some bank counterparties whereby
the parties agree to post cash collateral on financial derivatives,
for the benefit of the other, equivalent to the market valuation of
the derivative positions above a predetermined threshold. The
carrying value of such cash collateral held by the Group at 31
December 2022 was $89m (31 December 2021: $93m) and the carrying
value of such cash collateral posted by the Group at 31 December
2022 was $162m (31 December 2021: $47m). Cash collateral pledged to
counterparties is recognised as a financial asset and is included
in Other investments - current as at 31 December 2022. In prior
years, cash collateral pledged to counterparties was included in
Cash and cash equivalents.
The equivalent GAAP measure to Net Debt is 'liabilities arising
from financing activities', which excludes the amounts for cash and
overdrafts, other investments and non-financing derivatives shown
above and includes the Acerta Pharma share purchase liability of
$1,646m (31 December 2021: $2,458m), $867m of which is shown in
current other payables and $779m is shown in non-current other
payables.
Net Debt decreased by $1,399m in the year to $22,923m. Details
of the committed undrawn bank facilities are disclosed within the
going concern section of Note 1.
During the year ended 31 December 2022, Standard and Poor's
upgraded the Company's solicited credit ratings to long term: A;
and short term: A-1. There were no changes to Moody's solicited
credit ratings (long term: A3; short term: P-2).
Note 4: Financial Instruments
As detailed in the Group's most recent annual financial
statements, the principal financial instruments consist of
derivative financial instruments, other investments, trade and
other receivables, cash and cash equivalents, trade and other
payables, lease liabilities and interest-bearing loans and
borrowings.
The Group has certain equity investments that are categorised as
Level 3 in the fair value hierarchy that are held at $186m at 31
December 2022 (31 December 2021: $104m) and for which fair value
gains of $50m (FY 2021: $nil) have been recognised in the year
ended 31 December 2022. In the absence of specific market data,
these unlisted investments are held at fair value based on the cost
of investment and adjusting as necessary for impairments and
revaluations on new funding rounds, which are seen to approximate
the fair value. All other fair value gains and/or losses that are
presented in Net losses on equity investments measured at fair
value through other comprehensive income in the Condensed
consolidated statement of comprehensive income for the year ended
31 December 2022 are Level 1 fair value measurements, valued based
on quoted prices in active markets.
Financial instruments measured at fair value include $1,079m of
other investments, $4,486m held in money-market funds, $294m of
loans designated at fair value through profit or loss and ($96m) of
derivatives as at 31 December 2022. With the exception of
derivatives being Level 2 fair valued, certain equity investments
as described above and an equity warrant of $19m categorised as
Level 3, the aforementioned balances are Level 1 fair valued.
Financial instruments measured at amortised cost include $64m of
fixed deposits and $162m of cash collateral pledged to
counterparties. The total fair value of interest-bearing loans and
borrowings at 31 December 2022, which have a carrying value of
$29,232m in the Condensed consolidated statement of financial
position, was $27,898m.
Table 24 : Financial instruments - contingent consideration
2022 2021
Diabetes alliance Other Total Total
$m $m $m $m
-------------------------- ----------------- ----- ----- -----
At 1 January 2,544 321 2,865 3,323
--------------------------- ----------------- ----- ----- -----
Settlements (763) (9) (772) (643)
Disposals - (121) (121) -
Revaluations 182 (100) 82 14
Reclass to other payables - - - (55)
Discount unwind 161 7 168 226
--------------------------- ----------------- ----- ----- -----
At 31 December 2,124 98 2,222 2,865
--------------------------- ----------------- ----- ----- -----
Contingent consideration arising from business combinations is
fair valued using decision-tree analysis, with key inputs including
the probability of success, consideration of potential delays and
the expected levels of future revenues.
The contingent consideration balance relating to BMS's share of
the global diabetes alliance of $2,124m (31 December 2021: $2,544m)
would increase/decrease by $212m with an increase/decrease in sales
of 10%, as compared with the current estimates.
Note 5: Pensions and other post-retirement benefit
obligations
The net pensions and other post-retirement benefit obligations
position, as recorded under IAS 19 Employee Benefits, at 31
December 2022 was a liability of $1,078m (31 December 2021: $2,454m
liability). Pension schemes in a net surplus position at 31
December 2022 totalled $90m and are recorded within Other
receivables in non-current assets. Pension schemes in a net deficit
position at 31 December 2022 totalled $1,168m (31 December 2021:
$2,454m) and are recorded within Retirement benefit obligations in
non-current liabilities.
The decrease in the net liability of $1,376m is driven by
actuarial gains of $1,118m that have been reflected within the
Condensed consolidated statement of comprehensive income.
Changes in actuarial assumptions, primarily movements in
discount rates, led to an actuarial gain on scheme obligations in
the year of $3,585m (gains in UK, Sweden, US and RoW liabilities of
$2,243m, $806m, $268m and $268m respectively), which reflected
increases in corporate bond yields. These movements were partially
offset by actuarial losses on the pension fund asset values in the
year of $2,467m (losses in UK, Sweden, US and ROW assets of
$1,964m, $153m, $295m and $55m respectively).
Note 6: Legal proceedings and contingent liabilities
AstraZeneca is involved in various legal proceedings considered
typical to its business, including litigation and investigations,
including Government investigations, relating to product liability,
commercial disputes, infringement of intellectual property (IP)
rights, the validity of certain patents, anti-trust law and sales
and marketing practices. The matters discussed below constitute the
more significant developments since publication of the disclosures
concerning legal proceedings in the Company's Annual Report and
Form 20-F Information 2021, H1 2022 and Q3 2022 results (the
Disclosures). Unless noted otherwise below or in the Disclosures,
no provisions have been established in respect of the claims
discussed below.
As discussed in the Disclosures, the majority of claims involve
highly complex issues. Often these issues are subject to
substantial uncertainties and, therefore, the probability of a
loss, if any, being sustained and/or an estimate of the amount of
any loss is difficult to ascertain.
Unless specifically identified below that a provision has been
taken, AstraZeneca considers each of the claims to represent a
contingent liability and discloses information with respect to the
nature and facts of the cases in accordance with IAS 37.
There is one matter concerning legal proceedings in the
Disclosures, which is considered probable that an outflow will be
required, but for which we are unable to make an estimate of the
possible loss or range of possible losses at this stage.
In cases that have been settled or adjudicated, or where
quantifiable fines and penalties have been assessed and which are
not subject to appeal, or where a loss is probable and we are able
to make a reasonable estimate of the loss, AstraZeneca records the
loss absorbed or makes a provision for its best estimate of the
expected loss. The position could change over time and the
estimates that the Company made, and upon which the Company have
relied in calculating these provisions are inherently imprecise.
There can, therefore, be no assurance that any losses that result
from the outcome of any legal proceedings will not exceed the
amount of the provisions that have been booked in the accounts. The
major factors causing this uncertainty are described more fully in
the Disclosures and herein.
AstraZeneca has full confidence in, and will vigorously defend
and enforce, its IP.
Matters disclosed in respect of the fourth quarter of 2022 and
to 9 February 2023
Patent litigation
Calquence
US patent proceedings
As previously disclosed, in February 2022, in response to
Paragraph IV notices from multiple ANDA filers, AstraZeneca filed
patent infringement lawsuits in the US District Court for the
District of Delaware. In its complaint, AstraZeneca alleges that a
generic version of Calquence, if approved and marketed, would
infringe patents listed in the US FDA Orange Book with reference to
Calquence that are owned or licensed by AstraZeneca. Trial has been
scheduled for March 2025.
In February 2023, Sandoz Inc. filed a petition for inter partes
review with the US Patent and Trademark Office (USPTO) of certain
Calquence patent claims in US Patent No. 10,272,083 (the '083
patent)). AstraZeneca has asserted claims for infringement of the
'083 patent against Sandoz and other defendants in the US ANDA
litigation. AstraZeneca is considering its response to Sandoz's
petition before the USPTO.
Farxiga
US patent proceedings
As previously disclosed, i n 2018, in response to Paragraph IV
notices, AstraZeneca initiated abbreviated new drug application
(ANDA) litigation against Zydus Pharmaceuticals (USA) Inc. (Zydus)
in the US District Court for the District of Delaware (the District
Court). In May 2021, trial against Zydus proceeded and in October
2021, the District Court issued a decision finding the asserted
claims of AstraZeneca's patent as valid and infringed by Zydus's
ANDA product. In August 2022, Zydus appealed the District Court's
decision. In November 2022, Zydus's appeal was dismissed.
Additional ANDA challenges are pending.
Imjudo
US patent proceedings
In January 2023, Bristol-Myers Squibb Co. and E.R. Squibb &
Sons, LLC filed a lawsuit in US District Court for the District of
Delaware against AstraZeneca alleging that AstraZeneca's marketing
of Imjudo infringes two of their patents.
Lokelma
US patent proceedings
As previously disclosed, in August 2022, in response to
Paragraph IV notices, AstraZeneca initiated ANDA litigation against
multiple generic filers in the US District Court for the District
of Delaware. A trial has been scheduled for March 2025.
Symbicort
US patent proceedings
As previously disclosed, AstraZeneca is involved in two ongoing
ANDA patent litigations with Mylan Pharmaceuticals Inc. (Mylan) and
Kindeva Drug Delivery L.P. (Kindeva) brought in the US District
Court for the Northern District of West Virginia (the District
Court). In one of those matters, in November 2022, the District
Court determined that the asserted patent was invalid. AstraZeneca
appealed that decision to the United States Court of Appeals for
the Federal Circuit (the Federal Circuit). With respect to the
other matter, following a stipulation of infringement and validity
by Mylan and Kindeva that was subject to certain appeal issues, in
December 2022, the District Court issued a Final Judgment in favour
of AstraZeneca. In December 2022, Mylan and Kindeva appealed the
Final Judgment to the Federal Circuit. Both appeals are scheduled
to be heard in March 2023.
Tagrisso
Patent proceedings outside the US
As previously disclosed, in Russia in October 2021, AstraZeneca
filed a lawsuit in the Arbitration Court of the Moscow Region (the
Court) against Axelpharm, LLC to prevent it from obtaining
authorisation to market a generic version of Tagrisso prior to the
expiration of AstraZeneca's patents covering Tagrisso. The lawsuit
also names the Ministry of Health of the Russian Federation as a
third party. In March 2022, the Court dismissed the lawsuit. In
June 2022, the dismissal was affirmed on appeal. In January 2023,
the dismissal was affirmed on further appeal. AstraZeneca is
considering its option.
Lynparza
US patent proceedings
In December 2022, AstraZeneca received a Paragraph IV notice
letter from an ANDA filer relating to patents listed in the FDA
Orange Book with reference to Lynparza. AstraZeneca is reviewing
the notice letter.
Product liability litigation
Byetta /Bydureon
US proceedings
As previously disclosed, Amylin Pharmaceuticals, LLC (a wholly
owned subsidiary of AstraZeneca) and AstraZeneca are among multiple
defendants in various lawsuits filed in federal and state courts
involving claims of physical injury from treatment with Byetta
and/or Bydureon. The lawsuits allege several types of injuries
including pancreatic cancer and thyroid cancer. A multidistrict
litigation was established in the US District Court for the
Southern District of California (the District Court) in regard to
the alleged pancreatic cancer cases in federal courts. Further, a
coordinated proceeding has been established in Superior Court in
Los Angeles, California (the California Court) for cases in
California state courts. In March and April 2021, the District
Court and the California Court respectively granted Defendants'
summary judgment motions, dismissing all cases alleging pancreatic
cancer with prejudice. All remaining claims in both courts,
including those alleging thyroid cancer, have since been dismissed.
This matter is now concluded.
Nexium and Losec/Prilosec
US proceedings
As previously disclosed, AstraZeneca is defending various
lawsuits brought in US federal and state courts involving multiple
plaintiffs claiming that they have been diagnosed with various
injuries following treatment with proton pump inhibitors (PPIs),
including Nexium and Prilosec. The vast majority of these lawsuits
relate to allegations of kidney injuries. In August 2017, the
pending federal court cases were consolidated in a multidistrict
litigation ( MDL) proceeding in the US District Court for the
District of New Jersey for pre-trial purposes. A bellwether trial
has been scheduled for June 2023, with subsequent bellwether trials
scheduled for July and September 2023. In addition to the MDL
cases, there are cases filed in several state courts around the US;
a case that was previously set to go to trial in Delaware state
court was dismissed in October 2022.
Commercial Litigation
Anti-Terrorism Act Civil Lawsuit
As previously disclosed, in October 2017, AstraZeneca and
certain other pharmaceutical and/or medical device companies were
named as defendants in a complaint filed in US District Court for
the District of Columbia (the District Court) by US nationals (or
their estates, survivors, or heirs) who were killed or wounded in
Iraq between 2005 and 2013. The plaintiffs allege that the
defendants violated the US Anti-Terrorism Act and various state
laws by selling pharmaceuticals and medical supplies to the Iraqi
Ministry of Health. In July 2020, the District Court granted
AstraZeneca's and the other defendants' motion and dismissed the
lawsuit, and the plaintiffs appealed to the DC Circuit Court of
Appeals (the Appellate Court). In January 2022, a panel of the
Appellate Court reversed the dismissal and remanded the case back
to the District Court. AstraZeneca and the other defendants filed
petitions requesting en banc review by the entire Appellate Court,
which were denied in February 2023.
Employment Litigation (US)
In December 2022, AstraZeneca was served with a lawsuit filed by
seven former employees in the US District Court for the District of
Delaware asserting age, religion, and disability discrimination
claims related to AstraZeneca's COVID-19 vaccine mandate. These
claims are pled on a single-plaintiff and class action basis.
Pay Equity Litigation (US)
AstraZeneca is defending a putative class and collective action
matter in the US District Court for the Northern District of
Illinois brought by three named plaintiffs, who are former
AstraZeneca pharmaceutical sales representatives. The case involves
claims under the federal and Illinois Equal Pay Acts, with the
plaintiffs alleging they were paid less than male employees who
performed substantially similar and/or equal work. The plaintiffs
seek various damages on behalf of themselves and the putative class
and/or collective, including without limitation backpay, liquidated
damages, compensatory and punitive damages, attorneys' fees, and
interest. In January 2023, the District Court granted AstraZeneca's
motion to dismiss plaintiffs' complaint.
Government investigations/proceedings
Brazilian Operations Investigation (Brazil)
In May 2017, Brazilian authorities seized records and data from
Alexion's Brazil offices as part of an investigation being
conducted into Alexion's Brazilian operations. AstraZeneca
cooperated with this enquiry. The prosecutor recommended
discontinuance in September 2022 after determining that there was
insufficient evidence to support a legal claim. The judicial
authority approved discontinuance of the investigation, without any
further enforcement action, in November 2022. This matter is now
concluded.
Texas Qui Tam
US proceedings
In December 2022, AstraZeneca was served with an unsealed civil
lawsuit brought by a qui tam relator on behalf of the State of
Texas in Texas state court, which alleges that AstraZeneca engaged
in unlawful marketing practices.
US 340B Litigations and Proceedings
US proceedings
As previously disclosed, in January 2021, AstraZeneca filed a
lawsuit in US District Court for the District of Delaware (the
District Court) alleging that an Advisory Opinion issued by the
Department of Health and Human Services violates the Administrative
Procedure Act. AstraZeneca later amended its complaint to include
allegations challenging letters the US government issued in May
2021 asserting that AstraZeneca's contract pharmacy policy violates
the 340B statute. In February 2022, the District Court ruled in
favour of AstraZeneca. In January 2023, the Court of Appeals
affirmed the District Court decision.
Note 7: Subsequent events
On 9 January 2023, it was announced that AstraZeneca had entered
into a definitive agreement to acquire CinCor Pharma, Inc., a
US-based clinical-stage biopharmaceutical company, focused on
developing novel treatments for resistant and uncontrolled
hypertension as well as chronic kidney disease. On 23 January 2023,
AstraZeneca initiated a tender offer to acquire all of CinCor's
outstanding shares for a price of $26 per share in cash at closing,
plus a non-tradable contingent value right of $10 per share in cash
payable upon a specified regulatory submission of a baxdrostat
product. Combined, the upfront and maximum potential contingent
value payments represent, if achieved, a transaction value of
approximately $1.8bn. As part of the transaction, AstraZeneca will
acquire the cash and marketable securities on CinCor's balance
sheet, which totalled approximately $522m as of 30 September 2022.
The transaction is expected to close in the first quarter of
2023.
On 16 January 2023, AstraZeneca completed the acquisition of
Neogene Therapeutics Inc. AstraZeneca acquired all outstanding
equity of Neogene for a total consideration of up to $320m, on a
cash and debt free basis. This includes an initial payment of $200m
on deal closing, and a further up to $120m in both contingent
milestones-based and non-contingent consideration.
On 30 January 2023, AstraZeneca completed the sale of its West
Chester site in Ohio, US, to National Resilience, Inc. On
completion of the sale, the Property, plant and equipment assets
associated with this transaction of $150m which were recorded as
Assets held for sale as at 31 December 2022 have been disposed of,
with no net impact recorded in the Consolidated statement of
comprehensive income.
On 2 February 2023, the Group entered into an additional $2.0bn
of two-year committed bank facilities.
Table 25 : FY 2022 - Product Sales year-on-year analysis
[77]
The CER information in respect of FY 2022 included in the
Consolidated Financial Information has not been audited by
PricewaterhouseCoopers LLP.
World Emerging Markets US Europe Established RoW
$m Act % chg CER % chg $m Act % chg CER % chg $m % chg $m Act % chg CER % chg $m Act % chg CER % chg
-------------------- ------ --------- --------- ------ --------- --------- ------ ----- ----- --------- --------- ----- --------- ---------
Oncology 14,631 13 19 3,537 10 14 6,484 23 2,726 10 23 1,884 (5) 10
Tagrisso 5,444 9 15 1,567 17 22 2,007 13 1,023 4 17 847 (7) 8
Imfinzi 2,784 15 21 287 4 7 1,552 25 544 12 26 401 (1) 15
Lynparza 2,638 12 18 488 27 31 1,226 13 655 6 19 269 4 20
Calquence 2,057 66 69 45 n/m n/m 1,657 52 286 n/m n/m 69 n/m n/m
Enhertu 79 n/m n/m 51 n/m n/m - - 21 n/m n/m 7 n/m n/m
Orpathys 33 n/m n/m 33 n/m n/m - - - - - - - -
Zoladex 927 (2) 6 657 6 12 15 15 133 (10) 1 122 (28) (15)
Faslodex 334 (22) (14) 159 (4) 3 17 (45) 55 (52) (46) 103 (15) 1
Iressa 114 (38) (34) 94 (38) (35) 9 (19) 2 (52) (41) 9 (44) (35)
Arimidex 99 (29) (24) 76 (29) (26) - - - (87) (86) 23 (23) (11)
Casodex 78 (45) (40) 53 (50) (47) - - 1 (49) (48) 24 (31) (19)
Others 44 (14) (6) 27 (6) 1 1 59 6 (4) 4 10 (36) (26)
-------------------- ------ --------- --------- ------ --------- --------- ------ ----- ----- --------- --------- ----- --------- ---------
BioPharmaceuticals:
CVRM* 9,188 13 19 4,119 9 15 2,479 11 1,906 25 40 684 10 25
Farxiga 4,381 46 56 1,665 39 47 1,071 46 1,297 60 81 348 32 49
Brilinta 1,358 (8) (4) 286 (13) (10) 744 1 282 (18) (8) 46 (27) (22)
Lokelma 289 65 75 20 n/m n/m 170 47 30 n/m n/m 69 55 83
Roxadustat 197 13 18 197 13 18 - - - - - - - -
Andexxa* 150 5 14 - - - 77 (32) 41 41 58 32 n/m n/m
Crestor 1,048 (4) 2 794 2 9 65 (19) 41 (21) (12) 148 (21) (10)
Seloken /Toprol-XL 862 (9) (4) 839 (10) (4) - n/m 14 26 27 9 (16) (13)
Bydureon 280 (27) (26) 3 (16) (18) 242 (24) 35 (37) (29) - (95) (94)
Onglyza 257 (28) (25) 121 (32) (28) 76 (13) 38 (37) (29) 22 (32) (30)
Others 366 (10) (7) 194 (1) 4 34 (35) 128 (12) (10) 10 (32) (24)
-------------------- ------ --------- --------- ------ --------- --------- ------ ----- ----- --------- --------- ----- --------- ---------
BioPharmaceuticals:
R&I 5,765 (4) - 1,443 (18) (14) 2,655 10 1,054 (15) (5) 613 (3) 7
Symbicort 2,538 (7) (2) 608 - 5 973 (9) 582 (13) (3) 375 (2) 5
Fasenra 1,396 11 15 43 n/m n/m 906 15 305 7 20 142 (12) (1)
Breztri 398 96 n/m 92 68 75 239 n/m 33 n/m n/m 34 32 56
Saphnelo 116 n/m n/m - - - 111 n/m 2 n/m n/m 3 n/m n/m
Tezspire 4 n/m n/m - - - - - 2 n/m n/m 2 n/m n/m
Pulmicort 645 (33) (31) 462 (40) (39) 65 (9) 69 (6) 6 49 5 15
Daliresp/Daxas 189 (17) (16) 3 (28) (24) 176 (15) 9 (39) (32) 1 3 7
Bevespi 58 7 9 5 31 38 42 7 10 (7) 5 1 n/m n/m
Others 421 (29) (27) 230 (20) (17) 143 32 42 (77) (75) 6 (53) (46)
-------------------- ------ --------- --------- ------ --------- --------- ------ ----- ----- --------- --------- ----- --------- ---------
BioPharmaceuticals:
V&I 4,736 2 8 1,316 (43) (41) 1,168 n/m 1,027 (33) (24) 1,225 68 89
Vaxzevria 1,798 (54) (52) 729 (67) (67) 79 24 365 (65) (61) 625 8 17
Evusheld 2,185 n/m n/m 413 n/m n/m 1,067 n/m 298 n/m n/m 407 n/m n/m
Synagis 578 41 59 173 n/m n/m 1 (94) 213 5 17 191 28 51
FluMist 175 (31) (20) 1 (51) (54) 21 (21) 151 (32) (20) 2 (4) (10)
-------------------- ------ --------- --------- ------ --------- --------- ------ ----- ----- --------- --------- ----- --------- ---------
Rare Disease* 7,053 4 10 431 (10) 6 4,324 8 1,428 (3) 9 870 8 24
Soliris* 3,762 (11) (5) 301 (29) (10) 2,180 (7) 805 (21) (12) 476 11 24
Ultomiris* 1,965 34 42 38 n/m n/m 1,136 35 481 49 68 310 6 26
Strensiq* 958 16 18 35 41 31 769 19 78 (3) 9 76 (1) 16
Koselugo 208 93 96 26 n/m n/m 162 55 20 n/m n/m - - -
Kanuma* 160 16 19 31 73 61 77 12 44 (3) 10 8 21 38
-------------------- ------ --------- --------- ------ --------- --------- ------ ----- ----- --------- --------- ----- --------- ---------
Other medicines 1,625 (5) 4 788 (14) (9) 144 (16) 123 (28) (24) 570 28 50
Nexium 1,285 (3) 8 568 (19) (13) 120 (6) 46 (26) (17) 551 28 50
Others 340 (10) (7) 220 4 7 24 (45) 77 (29) (27) 19 37 54
-------------------- ------ --------- --------- ------ --------- --------- ------ ----- ----- --------- --------- ----- --------- ---------
Total Product Sales 42,998 18 24 11,634 (4) 1 17,254 44 8,264 9 22 5,846 22 40
-------------------- ------ --------- --------- ------ --------- --------- ------ ----- ----- --------- --------- ----- --------- ---------
Table 26 : Q4 2022 - Product Sales year-on-year analysis
[78]
The Q4 2022 information in respect of the three months ended 31
December 2022 included in the Consolidated Financial Information
has not been audited by PricewaterhouseCoopers LLP.
World Emerging Markets US Europe Established RoW
$m Act % chg CER % chg $m Act % chg CER % chg $m % chg $m Act % chg CER % chg $m Act % chg CER % chg
-------------------- ------ --------- --------- ----- --------- --------- ----- ----- ----- --------- --------- ----- --------- ---------
Oncology 3,746 9 18 814 4 14 1,789 23 689 4 21 454 (13 ) 7
Tagrisso 1,342 2 12 356 10 22 535 10 245 (5) 10 206 (16) 4
Imfinzi 752 19 27 63 (4) 3 450 37 142 3 20 97 (4) 18
Lynparza 689 10 17 130 27 33 331 13 162 - 16 66 (7) 15
Calquence 588 49 53 17 n/m n/m 465 39 86 n/m n/m 20 n/m n/m
Enhertu 28 n/m n/m 17 n/m n/m - - 8 n/m n/m 3 n/m n/m
Orpathys (1) n/m n/m (1) n/m n/m - - - - - - - -
Zoladex 210 (9) 4 149 (3) 10 4 71 33 (6) 10 24 (42) (25)
Faslodex 74 (27) (14) 38 (14) (2) 1 (76) 11 (46) (38) 24 (23) (3)
Iressa 24 (32) (24) 19 (34) (26) 3 55 - (44) 21 2 (52) (44)
Arimidex 14 (57) (50) 10 (61) (56) - - - - - 4 (39) (27)
Casodex 16 (28) (16) 10 (27) (16) - - 1 n/m n/m 5 (38) (23)
Others 10 (29) (18) 6 (18) (6) - - 1 (8) (10) 3 (40) (31)
-------------------- ------ --------- --------- ----- --------- --------- ----- ----- ----- --------- --------- ----- --------- ---------
BioPharmaceuticals:
CVRM 2,281 12 22 938 8 20 696 15 493 25 44 154 (11) 6
Farxiga 1,177 39 52 441 39 52 323 42 342 52 76 71 (8) 9
Brilinta 345 (1) 4 64 (11) (6) 206 16 67 (19) (6) 8 (48) (41)
Lokelma 81 50 63 6 n/m n/m 48 40 9 98 n/m 18 18 49
Roxadustat 49 65 87 49 66 87 - - - - - - - -
Andexxa 39 - 14 - - - 15 (51) 12 37 63 12 n/m n/m
Crestor 224 (13) (2) 164 (8) 4 15 (28) 11 24 42 34 (33) (18)
Seloken /Toprol-XL 157 (23) (12) 150 (24) (13) - - 4 n/m n/m 3 (23) (30)
Bydureon 73 (20) (20) - (51) (59) 66 (16) 7 (47) (38) - (49) (98)
Onglyza 52 (31) (24) 22 (20) (8) 16 (38) 9 (37) (26) 5 (36) (32)
Others 84 (13) (6) 42 (6) 6 7 (42) 32 (11) (8) 3 (13) (3)
-------------------- ------ --------- --------- ----- --------- --------- ----- ----- ----- --------- --------- ----- --------- ---------
BioPharmaceuticals:
R&I 1,447 (9 ) (3) 341 (23 ) (16 ) 692 7 259 (23 ) (10 ) 155 (5 ) 10
Symbicort 620 (9) (2) 133 (13) (3) 255 (2) 137 (20) (7) 95 (2) 11
Fasenra 381 7 12 13 n/m n/m 257 10 76 2 18 35 (18) (2)
Breztri 116 59 68 21 44 66 75 59 11 n/m n/m 9 8 34
Saphnelo 48 n/m n/m - - - 46 n/m 1 n/m n/m 1 n/m n/m
Tezspire 4 n/m n/m - - - - - 2 n/m n/m 2 n/m n/m
Pulmicort 166 (33) (28) 123 (36) (32) 12 (37) 19 (19) (7) 12 (5) 11
Daliresp /Daxas 28 (52) (52) 1 (53) (49) 25 (54) 2 (39) (30) - - -
Bevespi 14 (5) (1) 1 28 46 10 (1) 3 (27) (15) - - -
Others 70 (53) (47) 49 (36) (27) 12 (20) 8 (86) (83) 1 (57) (43)
-------------------- ------ --------- --------- ----- --------- --------- ----- ----- ----- --------- --------- ----- --------- ---------
BioPharmaceuticals:
V&I 1,129 (51 ) (44 ) 321 (74 ) (72 ) 226 n/m 334 (49 ) (40 ) 248 (25 ) (7)
Vaxzevria 85 (95) (94) 45 (96) (95) - - 40 (87) (84) - - -
Evusheld 734 n/m n/m 246 n/m n/m 217 n/m 99 50 74 172 n/m n/m
Synagis 194 (19) (3) 29 46 77 (1) n/m 90 (26) (14) 76 (21) (3)
FluMist 116 (35) (24) 1 (39) (43) 10 n/m 105 (39) (27) - (88) (86)
-------------------- ------ --------- --------- ----- --------- --------- ----- ----- ----- --------- --------- ----- --------- ---------
Rare Disease 1,816 4 10 116 (12) 2 1,149 10 349 (6 ) 7 202 (1) 19
Soliris 844 (22) (16) 83 (29) (12) 491 (19) 179 (26) (15) 91 (18) (4)
Ultomiris 593 52 62 4 (6) 8 365 71 134 34 53 90 23 52
Strensiq 272 24 27 10 59 48 224 29 19 (1) 13 19 (6) 16
Koselugo 58 74 77 3 n/m n/m 48 51 7 n/m n/m - - -
Kanuma 49 45 44 16 n/m n/m 21 18 10 (8) 4 2 68 n/m
-------------------- ------ --------- --------- ----- --------- --------- ----- ----- ----- --------- --------- ----- --------- ---------
Other medicines 379 (7) 7 180 1 12 32 (11 ) 28 (23 ) (19 ) 139 (12) 11
Nexium 300 (9) 7 131 1 13 26 (12) 9 (40) (32) 134 (13) 9
Others 79 (1) 5 49 1 8 6 (2) 19 (12) (10) 5 34 70
-------------------- ------ --------- --------- ----- --------- --------- ----- ----- ----- --------- --------- ----- --------- ---------
Total Product Sales 10,798 (6) 2 2,710 (25 ) (18 ) 4,584 19 2,152 (12) 1 1,352 (13) 6
-------------------- ------ --------- --------- ----- --------- --------- ----- ----- ----- --------- --------- ----- --------- ---------
Table 27 : Collaboration Revenue
FY 2022 FY 2021
$m $m
--------------------------------- ------- ----------
Enhertu : alliance revenue 519 193
Tezspire: alliance revenue 79 -
Lynparza : regulatory milestones 355 -
Lynparza : sales milestones - 400
Tralokinumab: sales milestones 110 -
Vaxzevria: royalties 76 64
Other royalty income 72 74
Other Collaboration Revenue 142 145
---------------------------------- ------- ----------
Total 1,353 876
---------------------------------- ------- ----------
Table 28 : Other Operating Income and Expense
FY 2022 FY 2021
$m $m
----------------------------------------------------- ------- -------
Brazikumab licence termination funding 138 99
Waltham site gain on sale and leaseback 125 -
Divestment of rights to Plendil 61 -
Divestment of Viela Bio, Inc. shareholding - 776
Crestor (Europe ex-UK and Spain) - 317
Late stage small-molecule antibiotics assets (ex-US) - 100
Other 190 200
------------------------------------------------------ ------- -------
Total 514 1,492
------------------------------------------------------ ------- -------
Other shareholder information
Financial calendar
Announcement of first quarter 2023 results 27 April 2023
Announcement of half year and second quarter 2023 results 28 July 2023
Announcement of year to date and third quarter 2023 results 9 November 2023
Dividends are normally paid as follows:
First interim: Announced with the half year results and paid in September
Second interim: Announced with full year results and paid in March
The record date for the second interim dividend for 2022,
payable on 27 March 2023, will be 24 February 2023. The ex-dividend
date will be 23 February 2023.
Contacts
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Addresses for correspondence
Registered office Registrar and Swedish Central US depositary
transfer office Securities Depository Deutsche Bank Trust
Company Americas
1 Francis Crick Equiniti Limited Euroclear Sweden American Stock Transfer
Avenue Aspect House AB PO Box 191 6201 15th Avenue
Cambridge Biomedical Spencer Road SE-101 23 Stockholm Brooklyn
Campus Lancing NY 11219
Cambridge West Sussex
CB2 0AA BN99 6DA
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 .
Cautionary statements regarding forward-looking statements
In order, among other things, to utilise the 'safe harbour'
provisions of the US Private Securities Litigation Reform Act of
1995, AstraZeneca (hereafter 'the Group') provides the following
cautionary statement:
This document contains certain forward-looking statements with
respect to the operations, performance and financial condition of
the Group, including, among other things, statements about expected
revenues, margins, earnings per share or other financial or other
measures. Although the Group believes its expectations are based on
reasonable assumptions, any forward-looking statements, by their
very nature, involve risks and uncertainties and may be influenced
by factors that could cause actual outcomes and results to be
materially different from those predicted. The forward-looking
statements reflect knowledge and information available at the date
of preparation of this document and the Group undertakes no
obligation to update these forward-looking statements. The Group
identifies the forward-looking statements by using the words
'anticipates', 'believes', 'expects', 'intends' and similar
expressions in such statements. Important factors that could cause
actual results to differ materially from those contained in
forward-looking statements, certain of which are beyond the Group's
control, include, among other things:
-- the ability of the Group and CinCor to complete the
transactions contemplated by the acquisition agreement, including
the parties' ability to satisfy the conditions to the consummation
of the offer contemplated thereby and the other conditions set
forth in the merger agreement;
-- the Group's and CinCor's beliefs and expectations and
statements about the benefits sought to be achieved in the Group's
proposed acquisition of CinCor;
-- the potential effects of the acquisition on both the Group and CinCor;
-- the possibility of any termination of the acquisition agreement;
-- the expected benefits and success of baxdrostat and any
combination product, the possibility that the milestone related to
the contingent value right will not be achieved;the risk of failure
or delay in delivery of pipeline or launch of new medicines
-- the risk of failure to meet regulatory or ethical
requirements for medicine development or approval
-- the risk of failures or delays in the quality or execution of
the Group's commercial strategies
-- the risk of pricing, affordability, access and competitive pressures
-- the risk of failure to maintain supply of compliant, quality medicines
-- the risk of illegal trade in the Group's medicines
-- the impact of reliance on third-party goods and services
-- the risk of failure in information technology or cybersecurity
-- the risk of failure of critical processes
-- the risk of failure to collect and manage data in line with
legal and regulatory requirements and strategic objectives
-- the risk of failure to attract, develop, engage and retain a
diverse, talented and capable workforce
-- the risk of failure to meet regulatory or ethical
expectations on environmental impact, including climate change
-- the risk of the safety and efficacy of marketed medicines being questioned
-- the risk of adverse outcome of litigation and/or governmental investigations
-- intellectual property-related risks to our products
-- the risk of failure to achieve strategic plans or meet targets or expectations
-- the risk of failure in financial control or the occurrence of fraud
-- the risk of unexpected deterioration in the Group's financial position
-- the impact that global and/or geopolitical events such as the
COVID-19 pandemic and the Russia-Ukraine war may have or continue
to have on these risks, on the Group's ability to continue to
mitigate these risks, and on the Group's operations, financial
results or financial condition
Nothing in this document, or any related presentation/webcast,
should be construed as a profit forecast. There can be no
guarantees that the conditions to the closing of the proposed
transaction with CinCor will be satisfied on the expected timetable
or at all or that baxdrostat or any combination product will
receive the necessary regulatory approvals or prove to be
commercially successful if approved.
- End of document -
[1] Constant exchange rates. The differences between Actual
Change and CER Change are due to foreign exchange movements between
periods in 2022 vs 2021. CER financial measures are not accounted
for according to generally accepted accounting principles (GAAP)
because they remove the effects of currency movements from Reported
results.
[2] Reported financial measures are the financial results
presented in accordance with UK-adopted International Accounting
Standards and International Financial Reporting Standards (IFRSs)
as issued by the International Accounting Standards Board (IASB)
and International Accounting Standards as adopted by the European
Union.
[3] Earnings per share.
[4] Core financial measures are adjusted to exclude certain
items. The differences between Reported and Core measures are
primarily due to costs relating to the acquisition of Alexion,
amortisation of intangibles, impairments, restructuring charges,
and, as previously disclosed, a charge to provisions relating to a
legal settlement with Chugai Pharmaceutical Co. Ltd (Chugai) that
led to a payment of $775m in Q2 2022. A full reconciliation between
Reported EPS and Core EPS is provided in Tables 11 and 12 in the
Financial performance section of this document.
[5] Cardiovascular, Renal and Metabolism.
[6] FY 2022 growth rates on medicines acquired with Alexion have
been calculated on a pro forma basis comparing to the corresponding
period in the prior year. In FY 2022, Total Revenue from Koselugo
is included in Rare Disease (FY 2021: Oncology) and Total Revenue
from Andexxa is included in BioPharmaceuticals: CVRM (FY 2021: Rare
Disease). The growth rate shown for each therapy area has been
calculated as though these changes had been implemented in FY
2021.
[7] Respiratory & Immunology.
[8] The COVID-19 medicines are Vaxzevria, Evusheld, and AZD3152
- the COVID-19 antibody currently in development.
[9] AstraZeneca is collaborating with MSD (Merck & Co., Inc.
in the US and Canada) to develop and commercialise Lynparza.
[10] Metastatic castration-resistant prostate cancer.
[11] Human epidermal growth factor receptor 2.
[12] Hepatocellular carcinoma.
[13] Non-small cell lung cancer.
[14] Mesenchymal-epithelial transition.
[15] Long-acting antibody.
[16] Vaxzevria is AstraZeneca's trademark for the Company's
supply of the AstraZeneca COVID-19 Vaccine. In the financial tables
in this report, 'Vaxzevria Total Revenue' includes Collaboration
Revenue from sub-licensees that produce and supply the AstraZeneca
COVID--19 Vaccine under their own trademarks.
[17] Volume-based procurement.
[18] Vaccines & Immune Therapies.
[19] In Table 2, the plus and minus symbols denote the
directional impact of the item being discussed, e.g. a '+' symbol
next to a R&D expense comment indicates that the item increased
the R&D expense relative to the prior year.
[20] Gross Profit is defined as Total Revenue minus Cost of
sales. The calculation of Reported and Core Gross Margin excludes
the impact of Collaboration Revenue.
[21] Where AstraZeneca does not retain a significant ongoing
interest in medicines or potential new medicines, income from
divestments is reported within Reported and Core Other operating
income and expense in the Company's financial statements.
[22] Chronic lymphocytic leukaemia.
[23] Heart failure with preserved ejection fraction.
[24] Respiratory syncytial virus.
[25] Neuromyelitis optica spectrum disorder.
[26] Hormone receptor.
[27] US Food and Drug Administration.
[28] Imfinzi Product Sales includes sales of Imjudo, which
commenced in Q4 2022.
[29] Alliance revenue (previously referred to as share of gross
profits) comprises income arising from collaborative arrangements,
where AstraZeneca is entitled to a profit share, but does not
include product sales where AstraZeneca is leading
commercialisation in a territory. Alliance revenue is included
within Collaboration Revenue.
[30] National reimbursement drug list.
[31] France, Germany, Italy, Spain, UK.
[32] Extensive-stage small cell lung cancer.
[33] Biliary tract cancer.
[34] Poly ADP ribose polymerase.
[35] Germline (hereditary) breast cancer gene mutation.
[36] Breast cancer gene mutation.
[37] Metastatic castration resistant prostate cancer.
[38] European Medicines Agency.
[39] Bruton tyrosine kinase inhibitor.
[40] Tyrosine kinase inhibitor.
[41] Sodium-glucose cotransporter 2.
[42] Heart failure.
[43] European Society of Cardiology.
[44] American Heart Association.
[45] American College of Cardiology.
[46] Heart Failure Society of America.
[47] Heart failure with reduced ejection fraction.
[48] Type-2 diabetes.
[49] Betaloc is the brand name for Seloken in China.
[50] Inhaled corticosteroid.
[51] Long-acting beta-agonist.
[52] Interleukin-5.
[53] The 'dynamic market' refers to patients who have recently
changed their medicine to a branded biologic. It captures patients
who have adopted a biologic medicine for the first time, and
patients who have switched from one biologic brand to another.
[54] Fixed dose combination.
[55] 'New-to-brand' share represents a medicine's share in the
dynamic market
[56] Intravenous injection.
[57] Systemic lupus erythematosus.
[58] Complement component 5.
[59] Paroxysmal nocturnal haemoglobinuria.
[60] Atypical haemolytic uraemic syndrome.
[61] Generalised myasthenia gravis.
[62] Other Operating Income.
[63] Other SG&A expense of $985m predominantly includes the
$775m charge to provisions relating to the legal settlement with
Chugai and $82m of fair value movements on contingent consideration
arising from business combinations.
[64] Other Taxation of ($1,049m) includes a one-off favourable
net adjustment of ($876m) to deferred taxes arising from an
internal reorganisation to integrate the Alexion organisation.
[65] Securities Exchange Commission.
[66] Based on best prevailing assumptions around currency
profiles.
[67] Based on average daily spot rates 1 Jan 2022 to 31 Dec
2022
[68] Based on average daily spot rates 1 Jan 2023 to 31 Jan
2023.
[69] Other currencies include AUD, BRL, CAD, KRW and RUB.
[70] Epidermal growth factor receptor.
[71] Programmed death-ligand 1.
[72] Prescription Drug User Fee Act.
[73] Supplemental new drug application.
[74] Overall survival.
[75] Ado-trastuzumab emtansine.
[76] Overall response rate.
[77] The table provides an analysis of year-on-year Product
Sales, with Actual and CER growth rates reflecting year-on-year
growth. Due to rounding, the sum of a number of dollar values and
percentages may not agree to totals. *FY 2022 growth rates on
medicines acquired with Alexion have been calculated on a pro forma
basis comparing to the corresponding period in the prior year. The
growth rates shown for Rare Disease and CVRM therapy area totals
include these pro forma adjustments.
[78] The table provides an analysis of year-on-year Product
Sales, with Actual and CER growth rates reflecting year-on-year
growth. Due to rounding, the sum of a number of dollar values and
percentages may not agree to totals.
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END
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