REG - AstraZeneca PLC - Final Results
09/02/2023 07:00
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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 (#_ftn1) $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 (#_ftn2) EPS 3 (#_ftn3) $2.12 n/m n/m $0.58 n/m n/m
Core 4 (#_ftn4) 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 (#_ftn5) increased
19% 6 (#_ftn6) , R&I 7 (#_ftn7) 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 (#_ftn8) 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 (#_ftn9) in mCRPC 10 (#_ftn10) (PROpel),
Enhertu in gastric cancer (DESTINY-Gastric01) and HER2 11 (#_ftn11) -low
breast cancer (DESTINY-Breast04), Imfinzi in biliary tract cancer (TOPAZ-1),
Imfinzi+Imjudo in HCC 12 (#_ftn12) 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 (#_ftn13) (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 (#_ftn14) 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 (#_ftn15) currently
in development) is expected to decline significantly in FY 2023, with minimal
revenue from Vaxzevria
‒ Total Revenue from China is expected to return to growth and
increase by a low single-digit percentage in FY 2023
‒ Collaboration Revenue and Other Operating Income are both expected
to increase, driven by continued growth of our partnered medicines,
success-based milestones, and certain anticipated transactions
‒ Core Operating Expenses are expected to increase by a low-to-mid
single-digit percentage, driven by investment in recent launches and the
ungating of new trials
‒ The Core Tax Rate is expected to be between 18-22%
The Company is unable to provide guidance on a Reported basis because it
cannot reliably forecast material elements of the Reported result, including
any fair value adjustments arising on acquisition-related liabilities,
intangible asset impairment charges and legal settlement provisions. Please
refer to the cautionary statements section regarding forward-looking
statements at the end of this announcement.
Currency impact
If foreign exchange rates for February to December 2023 were to remain at the
average rates seen in January 2023, it is anticipated that FY 2023 Total
Revenue and FY 2023 Core EPS would both incur a low single-digit adverse
impact versus the performance at CER.
The Company's foreign exchange rate sensitivity analysis is provided in Table
17.
Table 1: Key elements of Total Revenue performance in Q4 2022
% Change
Revenue type $m Actual CER
Product Sales 10,798 (6) 2 * Decline of 6% (2% increase at CER) due to lower sales of Vaxzevria 16
(#_ftn16)
* Strong growth in Oncology, CVRM and Rare Disease
Collaboration Revenue 409 (20) (19) * $188m for Enhertu (Q4 2021: $60m)
* $37m for Tezspire (Q4 2021: $nil)
* Milestone of $105m for Lynparza
Total Revenue 11,207 (7) 1 * Excluding Vaxzevria, Q4 2022 Total Revenue increased by 8% (17% at CER) -
see below
Therapy areas $m Actual CER
Oncology 4,046 4 12 * Strong performance across key medicines and regions
CVRM(6)( ) 2,284 12 22 * Farxiga up 39% (52% CER), Lokelma up 50% (63% at CER), roxadustat up 61%
(83% CER), Brilinta decreased 1% (increased 4% at CER)
R&I 1,485 (7) (1) * Growth in Fasenra, Breztri and Saphnelo offset by decline in Pulmicort of
33% (28% at CER) primarily due to the impact of VBP 17 (#_ftn17)
implementation in China
V&I 18 (#_ftn18) 1,163 (50) (43) * $734m from Evusheld (Q4 2021: $135m)
* $95m from Vaxzevria (Q4 2021: $1,762m)
Rare Disease(6)( ) 1,816 4 10 * Ultomiris up 52% (62% at CER) as gMG launch and conversion progressed;
offset by decline in Soliris
* Strensiq up 24% (27% at CER) reflecting strength of patient demand and
geographic expansion
Other Medicines 412 (2) 12
Total Revenue 11,207 (7) 1
Regions inc. Vaxzevria $m Actual CER
Emerging Markets 2,733 (25) (18) * Decline due to lower sales of Vaxzevria (growth rates excluding Vaxzevria
shown below)
- China 1,194 (9) 3 * Second consecutive quarter of growth at CER
- Ex-China Emerging Markets 1,538 (35) (29) * Decline due to lower sales of Vaxzevria
US 4,788 22 22
Europe 2,308 (20) (8) * Decline due to lower sales of Vaxzevria
Established RoW 1,378 (11) 8
Total Revenue inc. Vaxzevria 11,207 (7) 1
Regions exc. Vaxzevria $m Actual CER
Emerging Markets 2,678 7 18
- China 1,194 (8) 4 * Second consecutive quarter of growth at CER
- Ex-China Emerging Markets 1,484 24 33 * Strong growth in Oncology and CVRM
* $246m from Evusheld in Q4 (Q4 2021: $69m)
US 4,788 24 24 * Growth in Oncology medicines
Europe 2,268 (12) 1
Established RoW 1,378 4 27
Total Revenue exc. Vaxzevria 11,112 8 17
Table 2: Key elements of financial performance in Q4 2022
Metric Reported Reported change Core Core Comments 19 (#_ftn19)
change
Total Revenue $11,207m -7% Actual 1% CER $11,207m -7% Actual 1% CER * Excluding Vaxzevria, Q4 2022 Total Revenue increased by 8% (17% at CER)
* See Table 1 and the Total Revenue section of this document for further
details
Gross margin 20 (#_ftn20) 73% 13pp Actual 15pp CER 77% 3pp Actual 4pp CER + Increasing mix of sales from Oncology and Rare Disease medicines
+ Decreasing mix of Vaxzevria sales
‒ Negative impact in the quarter from currency fluctuations
‒ Inventory write downs and manufacturing termination fees relating to
Evusheld reduced Gross Profit by $335m in Q4 2022
‒ Mix impact from profit-sharing arrangements
(e.g. Lynparza)
‒ Reported Gross Margin impacted by unwind of Alexion inventory fair
value adjustment
R&D expense $2,625m 2% Actual 9% CER $2,526m 5% Actual 12% CER + Increased investment in the pipeline
* Core R&D-to-Total Revenue ratio of 23%
(Q4 2021: 20%)
SG&A expense $4,621m -10% Actual -3% CER $3,583m 6% Actual 15% CER + Market development activities for recent launches
+ Core SG&A-to-Total Revenue ratio of 32%
(Q4 2021: 28%). The year-on-year comparison is impacted by differences in cost
phasing during H2 2021 and H2 2022
Other operating income 21 (#_ftn21) $189m 29% Actual 33% CER $130m -11% Actual -7% CER * Reported and Core OOI includes income from sale of the Waltham site
Operating margin 10% 12pp Actual 14pp CER 23% -4pp Actual -3pp CER * See Gross Margin and Expenses
commentary above
Net finance expense $315m -6% Actual stable at CER $245m 5% Actual 9% CER * Reported impacted by a reduction in the discount unwind on
acquisition-related liabilities
Tax rate -16% n/m 10% -7pp Actual -6pp CER * The Reported and Core Tax Rates in the quarter reflected IP incentive
regimes, geographical mix of profits and adjustments to prior year tax
liabilities including several one-time items
* Variations in the tax rate can be expected to continue quarter to quarter
EPS $0.58 n/m $1.38 -17% Actual -5% CER * Further details of differences between Reported and Core are shown in Table
12
Table 3: Pipeline highlights since prior results announcement
Event Medicine Indication / Trial Event
Regulatory approvals and other regulatory actions Imfinzi +/- Imjudo NSCLC (1st-line) (POSEIDON) Regulatory approval (US, JP)
Imfinzi + Imjudo Hepatocellular carcinoma (1st-line) (HIMALAYA) Regulatory approval (JP)
Imfinzi Biliary tract cancer (TOPAZ-1) Regulatory approval (EU, JP)
Lynparza mCRPC (1st-line) (PROpel) Regulatory approval (EU)
Enhertu HER2-positive breast cancer (2nd-line) (DESTINY-Breast03) Regulatory approval (JP)
Enhertu HER2-low breast cancer (3rd-line) (DESTINY-Breast04) Regulatory approval (EU)
Enhertu HER2-positive/HER2-low gastric Regulatory approval (EU)
(2nd-line) (DESTINY-Gastric01,
DESTINY-Gastric02)
Calquence CLL 22 (#_ftn22) (ELEVATE-TN) Regulatory approval (JP)
Calquence Maleate tablet formulation Regulatory approval (EU)
Forxiga HFpEF 23 (#_ftn23) (DELIVER) Regulatory approval (EU, JP)
Airsupra Severe asthma (MANDALA/DENALI) Regulatory approval (US)
Tezspire Pre-filled pen Regulatory approval (US, EU)
Regulatory submissions Enhertu HER2-mutated NSCLC (2nd-line+) (DESTINY-Lung01) Regulatory submission (EU, JP)
or acceptances
Calquence CLL (ASCEND) Regulatory submission (CN)
Beyfortus RSV 24 (#_ftn24) (MELODY/MEDLEY) Regulatory submission (US)
Soliris NMOSD 25 (#_ftn25) Regulatory submission (CN)
Major Phase III data readouts and other developments Imfinzi NSCLC (1st-line) (PEARL) Primary endpoint not met
capivasertib HR 26 (#_ftn26) +/HER2-negative breast cancer (1st-line) (CAPItello-291) Fast Track Designation (US)
Orpathys + Tagrisso NSCLC with MET overexpression (SAVANNAH/SAFFRON) Fast Track Designation (US)
tozorakimab Treatment/prevention of acute respiratory failure in patients with viral lung Fast Track Designation (US)
infection (TILIA)
Saphnelo Idiopathic inflammatory myopathies Orphan Drug Designation (US)
Evusheld Pre-exposure prophylaxis of COVID-19 Revision of Emergency Use Authorisation (US) - Evusheld is not currently
authorised in the US until further notice from the FDA 27 (#_ftn27)
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 $0.8bn.
Sustainability summary
In November 2022, AstraZeneca achieved third position overall in the 2022
Access to Medicine Index.
In January 2023, Chair Leif Johansson alongside Senior Executive Team members
Marc Dunoyer, Dave Fredrickson and Iskra Reic attended the World Economic
Forum in Davos, focusing on investing in health as the foundation of strong
and resilient societies, and the need for collective early action to build
more sustainable and equitable healthcare systems, including through
collaborations such as the Partnership for Health System Sustainability and
Resilience and the Sustainable Markets Initiative.
Management changes
Katarina Ageborg, EVP Global Sustainability and Chief Compliance Officer, has
announced her retirement. Jeffrey Pott, Chief Human Resources Officer and
General Counsel, will assume responsibility as Chief Compliance Officer in
addition to his current responsibilities. Pam Cheng, Executive Vice-President,
Operations and Information Technology, will assume responsibility for
leadership of Sustainability strategy and function in addition to her existing
responsibilities. The Board thanks Katarina for her lasting legacy, having
positioned AstraZeneca amongst the global leaders in sustainability, backed by
world-leading platforms and science-based targets.
Conference call
A conference call and webcast for investors and analysts will begin today, 9
February 2023, at 11:45 GMT. Details can be accessed via astrazeneca.com
(https://www.astrazeneca.com/) .®
Reporting calendar
The Company intends to publish its results for the first quarter of 2023 on
Thursday 27 April 2023.
Operating and financial review
All narrative on growth and results in this section is based on actual
exchange rates, and financial figures are in US$ millions ($m), unless stated
otherwise. Unless stated otherwise, the performance shown in this announcement
covers the twelve-month period to 31 December 2022 ('the year' or 'FY 2022')
compared to the twelve-month period to 31 December 2021 (FY 2021), or the
three-month period to 31 December 2022 ('the fourth quarter' or 'Q4 2022')
compared to the three-month period to 31 December 2021 ('Q4 2021').
Core financial measures, EBITDA, Net Debt, Gross Margin, Operating Margin and
CER are non-GAAP financial measures because they cannot be derived directly
from the Group's Condensed Consolidated Financial Statements. Management
believes that these non-GAAP financial measures, when provided in combination
with Reported results, provide investors and analysts with helpful
supplementary information to understand better the financial performance and
position of the Group on a comparable basis from period to period. These
non-GAAP financial measures are not a substitute for, or superior to,
financial measures prepared in accordance with GAAP.
Core financial measures are adjusted to exclude certain significant items,
such as:
‒ Amortisation and impairment of intangible assets, including
impairment reversals but excluding any charges relating to IT assets
‒ Charges and provisions related to restructuring programmes, which
includes charges that relate to the impact of restructuring programmes on
capitalised IT assets
‒ Alexion acquisition-related items, primarily fair value adjustments
on acquired inventories and fair value impact of replacement employee share
awards
‒ Other specified items, principally the imputed finance charge
relating to contingent consideration on business combinations, legal
settlements and the one-off deferred tax credit arising from the internal
reorganisation to integrate Alexion
‒ The tax effects of the adjustments above are excluded from the Core
Tax charge
Details on the nature of Core financial measures are provided on page 54 of
the Annual Report and Form 20-F Information 2021
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2021/pdf/AstraZeneca_AR_2021.pdf)
.
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 (#_ftn28) 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 (#_ftn29) 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 (#_ftn30) 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 (#_ftn31) , partially offset by lower 2nd-line use
Established RoW * Increased use in 1st-line setting and launch progress in adjuvant, including
Japan
Imfinzi
Total Revenue Worldwide Emerging Markets US Europe Established RoW
FY 2022 $m 2,784 287 1,552 544 401
Actual change 15% 4% 25% 12% (1%)
CER change 21% 7% 25% 26% 15%
Region Drivers and commentary
Worldwide * The Imfinzi revenue line includes sales of Imjudo, which commenced in Q4
2022 following approvals in the US for patients with unresectable liver cancer
(HIMALAYA) and Stage IV NSCLC (POSEIDON)
* Increased use of Imfinzi in GI, liver and lung cancer
* Continued recovery in diagnosis and treatment rates following the COVID-19
pandemic across all regions, excluding China
Emerging Markets * Growth in ex-China driven by improved diagnosis and treatment rates
following the COVID‑19 pandemic
US * New patient starts across Stage III NSCLC and ES-SCLC 32 (#_ftn32)
* Strong launch in BTC 33 (#_ftn33) following September 2022 FDA approval
(TOPAZ-1), and growing penetration of Imfinzi + Imjudo in metastatic NSCLC and
HCC
Europe * Increased market penetration in ES-SCLC, growth in the number of reimbursed
markets, and ongoing recovery in rates of diagnosis and treatment
Established RoW * New reimbursements
Lynparza
Total Revenue Worldwide Emerging Markets US Europe Established RoW
FY 2022 $m 2,993 488 1,226 1,010 269
Actual change 9% 27% 13% (1%) 4%
CER change 14% 31% 13% 7% 20%
Product Sales Worldwide Emerging Markets US Europe Established RoW
FY 2022 $m 2,638 488 1,226 655 269
Actual change 12% 27% 13% 6% 4%
CER change 18% 31% 13% 19% 20%
Region Drivers and commentary
Worldwide * Lynparza remains the leading medicine in the PARP 34 (#_ftn34) 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 (#_ftn35) 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 (#_ftn36) 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 (#_ftn37) and gBRCAm
HER2-negative advanced breast cancer and the EU launch in gBRCAm early breast
cancer following EMA 38 (#_ftn38) approval in August (OlympiA)
Established RoW * New launches and high levels of HRD testing in Japan
Enhertu
Total Revenue Worldwide Emerging Markets US Europe Established RoW
FY 2022 $m 602 80 405 110 7
Actual change >2x >6x >2x >3x >10x
CER change >2x >6x >2x >3x >10x
Region Drivers and commentary
Worldwide * Excluding Japan, Enhertu global in-market sales recorded by Daiichi Sankyo
Company Limited (Daiichi Sankyo) and AstraZeneca, amounted to $1,173m in the
year (FY 2021: $426m)
* AstraZeneca's Total Revenue of $602m includes $523m of Collaboration Revenue
from its share of gross profit in territories where Daiichi Sankyo records
product sales and royalties on sales in Japan
Emerging Markets * Strong uptake in early launch markets
US * US in-market sales, recorded by Daiichi Sankyo, amounted to $850m in the
year (FY 2021: $357m)
* Now standard of care in 2nd-line HER2-positive metastatic breast cancer
following May 2022 FDA approval (DESTINY-Breast03) and after first
chemotherapy in HER2-low metastatic breast cancer following August 2022 FDA
approval (DESTINY-Breast04)
Europe * Growth in 3rd-line+ HER2-positive metastatic breast and launch in 2nd-line
HER2-positive metastatic breast cancer after EMA approval in July 2022
(DESTINY-Breast03)
Established RoW * In Japan, AstraZeneca receives a mid-single-digit percentage royalty on
sales made by Daiichi Sankyo
Calquence
Total Revenue Worldwide Emerging Markets US Europe Established RoW
FY 2022 $m 2,057 45 1,657 286 69
Actual change 66% >2x 52% >2x >3x
CER change 69% >2x 52% >2x >4x
Region Drivers and commentary
Worldwide * Increased penetration globally; leading BTKi 39 (#_ftn39) 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 (#_ftn40)
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 (#_ftn41) market
in all major regions
* Additional benefit from continued growth in the overall SGLT2 inhibitor
class
* Further HF 42 (#_ftn42) and CKD launches and supportive updates to
treatment guidelines including from ESC 43 (#_ftn43) and AHA 44 (#_ftn44)
/ACC 45 (#_ftn45) /HFSA 46 (#_ftn46) . 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 (#_ftn47) in May 2020, treatment of CKD in
May 2021. Both approvals included patients with and without T2D 48 (#_ftn48)
* Farxiga continued to gain in-class brand share, driven by HF and CKD
launches
Europe * The beneficial addition of cardiovascular outcomes trial data to the label,
the HFrEF regulatory approval in November 2020, and CKD regulatory approval in
August 2021
* Forxiga continued gaining in-class market share in the period
Established RoW * In Japan, AstraZeneca sells to collaborator Ono Pharmaceutical Co., Ltd,
which records in-market sales. Continued volume growth driven by HF and CKD
launches
Brilinta
Total Revenue Worldwide Emerging Markets US Europe Established RoW
FY 2022 $m 1,358 286 744 282 46
Actual change (8%) (13%) 1% (18%) (27%)
CER change (4%) (10%) 1% (8%) (22%)
Region Drivers and commentary
Emerging Markets * Adverse impact from Brilinta's inclusion in China's VBP programme
* Growth in ex-China Emerging Markets
US, Europe * Q4 US sales growth favourably impacted by a one-time adjustment. Some market
recovery of oral antiplatelet therapies following the pandemic
Lokelma
Total Revenue increased 65% (75% at CER) to $289m in FY 2022, driven by
Lokelma extending its branded market share lead in the US and also achieving
total potassium binder market share leadership in the period. Continued
progress in Europe from recent launches across the region where Lokelma
extended its market share in the period. In China, Lokelma was admitted to the
NRDL with effect from 1 January 2022 and is now the leading potassium binder
in the country.
Roxadustat
Total Revenue increased 12% (17% at CER) to $202m, with roxadustat benefitting
from increased volumes in China following NRDL price cuts.
Andexxa
On a pro forma basis, Andexxa Total Revenue increased 12% (21% at CER) to
$160m.
Other CVRM medicines
FY 2022 % Change
Total Revenue $m Actual CER
Crestor 1,050 (4%) 2% * Sales growth at CER driven by Emerging Markets, offset by declines in the US
and Europe
Seloken 863 (9%) (4%) * Emerging Markets sales impacted by China VBP implementation of Betaloc 49
(#_ftn49) 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 (#_ftn50)
/LABA 51 (#_ftn51) class
Emerging Markets * Growth driven primarily by Latin America, Middle East and Asia Area, offset
by decrease in China due to COVID-19 restrictions
US * Strong market share performance, consolidating leadership in a declining
ICS/LABA market, offset by pricing pressure
Europe * Resilient market share in growing ICS/LABA market, offset by pricing
pressure
Established RoW * Growth in some countries driven by share gains and a continued recovery in
the ICS/LABA market. That growth was offset by generic erosion in other
countries
Fasenra
Total Revenue Worldwide Emerging Markets US Europe Established RoW
FY 2022 $m 1,396 43 906 305 142
Actual change 11% >2x 15% 7% (12%)
CER change 15% >2x 15% 20% (1%)
Region Drivers and commentary
Worldwide * Fasenra continues to be market leader in severe eosinophilic asthma in major
markets, and leading in the IL-5 52 (#_ftn52) class
Emerging Markets * Strong volume growth driven by launch acceleration across key markets
US * Maintained a strong total patient share in the severe asthma market
Europe * Sustained growth by expanding leadership in severe eosinophilic asthma
Established RoW * Maintained market leadership in Japan, partially offset by price adjustments
and impact in the dynamic market 53 (#_ftn53) 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 (#_ftn54)
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 (#_ftn55) and total market share growth within
the FDC triple class
Europe * Sustained growth across markets as new launches continue to progress
Established RoW * Strong new-to-brand market share performance in Japan, with the dynamic
market impacted by access restrictions related to the rise in COVID-19 cases
Saphnelo
Total Revenue of $116m in the year (FY 2021: $8m) was driven by demand
acceleration in the US, where Saphnelo achieved new-to-brand leadership in the
i.v. 56 (#_ftn56) segment for SLE 57 (#_ftn57) and received a permanent
J-code facilitating reimbursement. Growth was further supported by launches in
Germany and Japan during the year.
Tezspire
Tezspire is approved in the US, EU and Japan (as well as other countries) for
the treatment of severe asthma without biomarker or phenotypic limitation.
Collaboration Revenue of $82m in the year (FY 2021: $nil) reflected the strong
early launch performance in the US. In Europe and Established RoW, AstraZeneca
recorded $4m revenue ($2m in each region).
Amgen records sales in the US and AstraZeneca records its share of gross
profits in the US as Collaboration Revenue. Total ex-US product sales are
recorded as AstraZeneca revenue ($4m in 2022). Global in-market sales of
Tezspire were $174m in 2022.
Other R&I medicines
FY 2022 % Change
Total Revenue $m Actual CER
Pulmicort 645 (33%) (31%) * Emerging Markets revenue decreased 40% (39% at CER) to $462m, impacted by
VBP implementation in China, lower rates of hospitalisations and limited
access to nebulisation centres in China due to COVID-19 lockdowns
* Revenues in Ex-China Emerging Markets grew following recovery of
nebulisation demand
Daliresp/Daxas 189 (17%) (16%) * Impacted by uptake of multiple generics following loss of exclusivity in the
US
* Total Revenue in the fourth quarter decreased by 52%
Bevespi 58 7% 9%
Other R&I 540 (11%) (9%) * Collaboration Revenue of $119m (FY 2021: $15m), including $110m of
milestones relating to tralokinumab (FY 2021: $nil)
* Product Sales of $421m decreased 29% (27% at CER)
BioPharmaceuticals - V&I
Total Revenue from V&I medicines was broadly flat at $4,836m (FY 2021:
$4,779m) and represented 11% of overall Total Revenue (FY 2021: 13%).
Vaxzevria
Total Revenue Worldwide Emerging Markets US Europe Established RoW
FY 2022 $m 1,875 805 79 365 625
Actual change (53%) (65%) 24% (65%) 8%
CER change (51%) (65%) 24% (61%) 17%
Region Drivers and commentary
Worldwide * Revenue in the fourth quarter decreased by 95% (94% at CER) due to the
conclusion of Vaxzevria contracts
Emerging Markets * $76m of Collaboration Revenue from sub-licensees in FY 2022, including $46m
in Q1 2022 from a Chinese sub-licensee producing vaccines for export
* Revenue in the fourth quarter decreased by 95%
US * Purchases by the US Government for donation overseas in Q1 2022
* No revenue was recorded after Q1 2022
Europe * Revenue in the fourth quarter decreased by 87% (84% at CER) vs Q4 2021
Established RoW * No revenue was recorded for Established RoW in the fourth quarter
Evusheld
Total Revenue Worldwide Emerging Markets US Europe Established RoW
FY 2022 $m 2,184 413 1,067 298 407
Actual change >10x >6x n/m >4x n/m
CER change >10x >6x n/m >5x n/m
Region Drivers and commentary
US * AstraZeneca fulfilled the US Government's order for 1.7 million units during
the year
Emerging Markets * Government contracts in Central and Eastern Europe, Latin America and South
East Asia
Europe * Approved in the EU for prevention of COVID-19 in March 2022 and treatment of
COVID-19 in September 2022
Established RoW * Approved in Japan for prevention and treatment of COVID-19 in August 2022
Other V&I medicines
FY 2022 % Change
Total Revenue $m Actual CER
Synagis 578 41% 59% * Ex-US rights reverted to AstraZeneca after 30 June 2021, from AbbVie Inc.
* In Q4 2022, Synagis sales decreased by 19% (3% CER), reflecting the early
start to the RSV season in the prior year period
FluMist 175 (31%) (20%) * Late start to the influenza season in Europe
Rare Disease
On a pro forma basis, Total Revenue from Rare Disease medicines increased by
4% (10% at CER) in FY 2022 to $7,053m, representing 16% of overall Total
Revenue.
Performance was driven by the durability of the C5 58 (#_ftn58) 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
(#_ftn59) , aHUS 60 (#_ftn60) and gMG 61 (#_ftn61) , partially offset by
Soliris growth in NMOSD
Ex-US * Decline driven by successful conversion to Ultomiris, slightly offset by
growth in NMOSD and expansion in new markets
Ultomiris
Total Revenue Worldwide Emerging Markets US Europe Established RoW
FY 2022 $m 1,965 38 1,136 481 310
Actual change(6) 34% >2x 35% 49% 6%
CER change(6) 42% >2x 35% 68% 26%
Region Drivers and commentary
Worldwide * Performance driven by gMG launch in the US and expansion into new markets
* Quarter-on-quarter variability in revenue growth can be expected due to
Ultomiris every eight-week dosing schedule and lower average annual treatment
cost per patient compared to Soliris
US * Performance driven by successful conversion from Soliris across PNH, aHUS
and gMG
Europe * Growth driven by strong demand generation following new launch markets
Established RoW * Rapid conversion in new launch markets, strong growth in Japan following gMG
launch
Other Rare Disease medicines
FY 2022 % Change
Total Revenue $m Actual CER Commentary
Strensiq 958 16% 18% * Performance driven by strong patient demand and geographic expansion
Koselugo 208 93% 96% * Growth driven by expansion in new markets
Kanuma 160 16% 19% * Continued demand growth in ex-US markets
Other medicines (outside the main therapy areas)
FY 2022 % Change
Total Revenue $m Actual CER Commentary
Nexium 1,367 (4%) 7% * Nexium (oral) was implemented in China's VBP programme in February 2021 and
Nexium i.v. was implemented in October 2021
* Generic competition in Japan increased in the fourth quarter
Others 381 (4%) (1%)
Financial performance
Table 9: Reported Profit and Loss
FY 2022 FY 2021 % Change Q4 2022 Q4 2021 % Change
$m $m Actual CER $m $m Actual CER
Total Revenue 44,351 37,417 19 25 11,207 12,011 (7) 1
- Product Sales 42,998 36,541 18 24 10,798 11,498 (6) 2
- Collaboration Revenue 1,353 876 54 56 409 513 (20) (19)
Cost of sales (12,391) (12,437) - 4 (2,900) (4,625) (37) (35)
Gross profit 31,960 24,980 28 35 8,307 7,386 12 24
Gross Margin 71.2% 66.0% +5pp +5pp 73.1% 59.8% +13pp +15pp
Distribution expense (536) (446) 20 29 (156) (124) 26 38
% Total Revenue 1.2% 1.2% - - 1.4% 1.0% - -
R&D expense (9,762) (9,736) - 5 (2,625) (2,584) 2 9
% Total Revenue 22.0% 26.0% +4pp +4pp 23.4% 21.5% -2pp -2pp
SG&A expense (18,419) (15,234) 21 26 (4,621) (5,117) (10) (3)
% Total Revenue 41.5% 40.7% -1pp - 41.2% 42.6% +1pp +2pp
OOI 62 (#_ftn62) & expense 514 1,492 (66) (65) 189 147 29 33
% Total Revenue 1.2% 4.0% -3pp -3pp 1.7% 1.2% - -
Operating profit/(loss) 3,757 1,056 >3x >3x 1,094 (292) n/m n/m
Operating Margin 8.5% 2.8% 6 7 9.8% -2.4% +12pp +14pp
Net finance expense (1,251) (1,257) (1) 5 (315) (335) (6) -
Joint ventures and associates (5) (64) (92) (91) (1) (9) (89) (89)
Profit/(loss) before tax 2,501 (265) n/m n/m 778 (636) n/m n/m
Taxation 792 380 >2x >3x 124 290 (57) 21
Tax rate -32% 143% -16% 46%
Profit/(loss) after tax 3,293 115 n/m n/m 902 (346) n/m n/m
Earnings per share $ 2.12 $0.08 n/m n/m $0.58 $(0.22) n/m n/m
Table 10: Reconciliation of Reported Profit before tax to EBITDA
FY 2022 FY 2021 % Change Q4 2022 Q4 2021 % Change
$m $m Actual CER $m $m Actual CER
Reported Profit/(loss) before tax 2,501 (265) n/m n/m 778 (636) n/m n/m
Net finance expense 1,251 1,257 (1) 5 315 335 (6) -
Joint ventures and associates 5 64 (92) (91) 1 9 (89) (89)
Depreciation, amortisation and impairment 5,480 6,530 (16) (12) 1,480 2,192 (32) (28)
EBITDA 9,237 7,586 22 33 2,574 1,900 36 56
EBITDA of $9,237m in the year (FY 2021: $7,586m) has been negatively impacted
by the $3,484m (FY 2021: $2,198m) unwind of inventory fair value uplift
recognised on the acquisition of Alexion. EBITDA of $2,574m in the quarter (Q4
2021: $1,900m) has been negatively impacted by the $309m (Q4 2021: $1,154m)
unwind of inventory fair value uplift recognised on the acquisition of
Alexion. The unwind of the remaining $114m inventory fair value uplift is
expected to depress EBITDA in 2023.
Table 11: Reconciliation of Reported to Core financial measures: FY 2022
FY 2022 Reported Restructuring Intangible Asset Amortisation & Impairments Acquisition Other Core Core
of Alexion
% Change
$m $m $m $m $m $m Actual CER
Gross profit 31,960 266 32 3,506 (1) 35,763 28 35
Gross Margin 71.2% 80.0% +6pp +6pp
Distribution expense (536) 2 - - - (534) 20 28
R&D expense (9,762) 111 124 27 - (9,500) 19 24
SG&A expense (18,419) 405 4,165 38 985 63 (#_ftn63) (12,826) 15 21
Total operating expense (28,717) 518 4,289 65 985 (22,860) 17 23
Other operating income & expense 514 (67) - - - 447 (70) (69)
Operating profit 3,757 717 4,321 3,571 984 13,350 34 42
Operating Margin 8.5% 30.1% +4pp +4pp
Net finance expense (1,251) - - - 277 (974) 13 18
Taxation 792 (165) (804) (832) (1,049) 64 (#_ftn64) (2,058) 38 46
EPS $2.12 $0.36 $2.27 $1.77 $0.14 $6.66 26 33
Table 12: Reconciliation of Reported to Core financial measures: Q4 2022
Q4 2022 Reported Restructuring Intangible Asset Amortisation & Impairments Acquisition Other Core Core
of Alexion
% Change
$m $m $m $m $m $m Actual CER
Gross profit 8,307 110 8 320 - 8,745 (3) 6
Gross Margin 73.1% 77.2% +3pp +4pp
Distribution Expense (156) - - - - (156) 27 39
R&D expense (2,625) 54 41 4 - (2,526) 5 12
SG&A expense (4,621) 142 1,105 3 (212) (3,583) 6 15
Total operating expense (7,402) 196 1,146 7 (212) (6,265) 6 14
Other operating income & expense 189 (59) - - - 130 (11) (7)
Operating profit 1,094 247 1,154 327 (212) 2,610 (21) (10)
Operating Margin 9.8% 23.3% -4pp -3pp
Net finance expense (315) - - - 70 (245) 5 9
Taxation 124 (72) (223) (84) 29 (226) (55) (44)
EPS $0.58 $0.11 $0.60 $0.16 ($0.07) $1.38 (17) (5)
Profit and Loss drivers
Gross profit
‒ The Gross Margin (Reported and Core) in the year was impacted by:
‒ Positive mix effects: the increased contribution from Rare Disease
and Oncology medicines had a positive impact on the Gross Margin
‒ Negative mix effects: sales of Vaxzevria and medicines with
profit-sharing arrangements (primarily Lynparza) had a dilutive impact on the
Gross Margin
‒ Inventory write downs and provisions for excess manufacturing
reservation fees relating to Evusheld
‒ Pricing pressure relating to procurement programmes in China
‒ Reported Gross Profit was also impacted by the unwind of the fair
value adjustment to Alexion inventories at the date of acquisition. The fair
value uplift is expected to unwind through Reported Cost of sales in line with
associated revenues, and in FY 2022, the impact of the fair value uplift
unwind on Cost of sales was $3,484m (FY 2021: $2,198m)
‒ Currency fluctuations had a small positive impact on Gross Margin in
the year. Currency fluctuations may have a positive or negative impact on
Gross Margin in future quarters
‒ Variations in Gross Margin performance between periods can be
expected to continue
R&D expense
‒ The increase in Reported and Core R&D expense was impacted by:
‒ The acquisition of Alexion in July 2021
‒ Recent positive data read outs for several high priority medicines
that ungated late-stage Oncology trials
‒ The advancement of a number of mid-stage clinical development
programmes in BioPharmaceuticals
‒ Investment in platforms, new technology and capabilities to enhance
R&D productivity
SG&A expense
‒ The increase in Reported and Core SG&A expense was driven by:
‒ The acquisition of Alexion in July 2021
‒ Market development activities for launches
‒ Reported SG&A expense was also impacted by amortisation of
intangible assets related to the Alexion acquisition and other acquisitions
and collaborations, and a $775m legal settlement with Chugai
Other operating income
‒ Reported Other operating income of $514m consisted primarily of
disposal proceeds on small divestments, including the divestment of rights to
Plendil in the second quarter, disposal proceeds on sale of tangible assets,
and royalties
‒ In FY 2021, Reported Other operating income of $1,492m included
$776m of divestment gains from AstraZeneca's share of Viela Bio, Inc. and
$317m from the divestment of commercial rights to Crestor in over 30 countries
in Europe (excluding UK and Spain)
Net finance expense
‒ The change in Reported and Core Net finance expense in the year was
primarily driven by financing costs on debt for the Alexion transaction.
Reported Net finance expense was also impacted by a reduction in the discount
unwind on acquisition-related liabilities, including the Diabetes Alliance
Taxation
‒ The effective Reported Tax Rate for the year was -32% (FY 2021:
143%) and the Core Tax rate was 17% (FY 2021: 17%)
‒ The Reported Tax Rate for the year included a one-time favourable
net adjustment of $876m to deferred taxes arising from an internal
reorganisation to integrate the Alexion organisation which took place in the
third quarter. The internal legal entity reorganisation did not result in any
corporate income tax becoming payable in the year, however it did result in a
one-off deferred tax adjustment of $876m to the income statement, and a
further $49m credit associated with the reorganisation is included in Other
Comprehensive Income. Following the reorganisation, it was necessary to
re-measure certain deferred tax balances to reflect the tax rates applicable
on their reversal as under the revised structure there is a change in the
income flows to the relevant territories
‒ The Reported Tax rate of -32% was lower than the Core Tax Rate of
17% primarily due to the impact of the aforementioned internal restructuring.
The 2022 Reported and Core Tax rates also benefited from IP incentive regimes,
geographical mix of profits and net favourable adjustments to prior year tax
liabilities in a number of major jurisdictions, many of which were one-time
items
‒ 2021 Reported and Core Tax rates were impacted by one-off items in
2021, including the non-taxable gain on the divestment of Viela Bio, Inc and
updates to estimates of prior period tax liabilities following settlements
with tax authorities
‒ The net cash paid for the year was $1,623m (2021: $1,743m)
representing 65% of Reported Profit before tax (2021: -658%). The cash tax
amount decreased due to refunds received in the year relating to prior periods
and phasing of payments between current and future years
‒ On 20 July 2022, the UK Government issued draft legislation in
relation to the new global minimum tax framework, expected to be brought into
effect in the UK from 2024. The UK corporation tax rate continues to be
expected to increase to 25%, effective April 2023. The Company is currently
assessing the potential impact of these draft rules upon its financial
statements
Dividend per share
‒ A second interim dividend of $1.97 per share (162.8 pence, 20.69
SEK) has been declared, meaning a full-year dividend per share of $2.90 (239.2
pence, 30.18 SEK). Dividend payments are normally paid as follows:
‒ First interim dividend - announced with half-year and second-quarter
results and paid in September
‒ Second interim dividend - announced with full-year and
fourth-quarter results and paid in March
‒ The record date for the second interim dividend for 2022, payable on
27 March 2023, will be 24 February 2023. The ex-dividend date will be 23
February 2023. The record date for the first interim dividend for 2023,
payable on 11 September 2023, will be 11 August 2023. The ex-dividend date
will be 10 August 2023.
Table 13: Cash Flow summary
FY 2022 FY 2021 Change
$m $m $m
Reported Operating Profit 3,757 1,056 2,701
Depreciation, Amortisation and Impairment 5,480 6,530 (1,050)
Decrease in Working Capital and Short-term Provisions 3,757 2,021 1,736
Gains on Disposal of Intangible Assets (104) (513) 409
Gains on Disposal of Investments in Associates and Joint Ventures - (776) 776
Fair value movements on contingent consideration arising from business 82 14 68
combinations
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 6,398
Overdrafts and short-term borrowings (350) (387)
Lease liabilities (953) (987)
Current instalments of loans (4,964) (1,273)
Non-current instalments of loans (22,965) (28,134)
Interest-bearing loans and borrowings (Gross Debt) (29,232) (30,781)
Net derivatives (96) 61
Net Debt (22,923) (24,322)
Net Debt decreased by $1,399m in the year to $22,923m. Details of the
committed undrawn bank facilities are disclosed within the going concern
section of Note 1. Details of the Company's solicited credit ratings are
disclosed in Note 3.
Capital allocation
The Board's aim is to continue to strike a balance between the interests of
the business, financial creditors and the Company's shareholders. The
Company's capital allocation priorities include: investing in the business and
pipeline; maintaining a strong, investment-grade credit rating; potential
value-enhancing business development opportunities; and supporting the
progressive dividend policy.
In approving the declaration of dividends, the Board considers both the
liquidity of the company and the level of reserves legally available for
distribution. Dividends are paid to shareholders from AstraZeneca PLC, a Group
holding company with no direct operations. The ability of AstraZeneca PLC to
make shareholder distributions is dependent on the creation of profits for
distribution and the receipt of funds from subsidiary companies. The
consolidated Group reserves set out in the Condensed consolidated statement of
financial position do not reflect the profit available for distribution to the
shareholders of AstraZeneca PLC.
Summarised financial information for guarantee of securities of subsidiaries
AstraZeneca Finance LLC ("AstraZeneca Finance") is the issuer of 0.700% Notes
due 2024, 1.200% Notes due 2026, 1.750% Notes due 2028 and 2.250% Notes due
2031 (the "AstraZeneca Finance Notes"). Each series of AstraZeneca Finance
Notes has been fully and unconditionally guaranteed by AstraZeneca PLC.
AstraZeneca Finance is 100% owned by AstraZeneca PLC and each of the
guarantees by AstraZeneca PLC is full and unconditional and joint and several.
The AstraZeneca Finance Notes are senior unsecured obligations of AstraZeneca
Finance and rank equally with all of AstraZeneca Finance's existing and future
senior unsecured and unsubordinated indebtedness. The guarantee by AstraZeneca
PLC of the AstraZeneca Finance Notes is the senior unsecured obligation of
AstraZeneca PLC and ranks equally with all of AstraZeneca PLC's existing and
future senior unsecured and unsubordinated indebtedness. Each guarantee by
AstraZeneca PLC is effectively subordinated to any secured indebtedness of
AstraZeneca PLC to the extent of the value of the assets securing such
indebtedness. The AstraZeneca Finance Notes are structurally subordinated to
indebtedness and other liabilities of the subsidiaries of AstraZeneca PLC,
none of which guarantee the AstraZeneca Finance Notes.
AstraZeneca PLC manages substantially all of its operations through divisions,
branches and/or investments in subsidiaries and affiliates. Accordingly, the
ability of AstraZeneca PLC to service its debt and guarantee obligations is
also dependent upon the earnings of its subsidiaries, affiliates, branches and
divisions, whether by dividends, distributions, loans or otherwise.
Please refer to the consolidated financial statements of AstraZeneca PLC in
our Annual Report on Form 20-F and reports on Form 6-K with our quarterly
financial results as filed or furnished with the SEC 65 (#_ftn65) 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
$m
Current assets 4
Non-current assets -
Current liabilities (2,839)
Non-current liabilities (22,797)
Amounts due from subsidiaries that are not issuers or guarantors 7,806
Amounts due to subsidiaries that are not issuers or guarantors (293)
Foreign exchange
The Company's transactional currency exposures on working-capital balances,
which typically extend for up to three months, are hedged where practicable
using forward foreign exchange contracts against the individual companies'
reporting currency. Foreign exchange gains and losses on forward contracts for
transactional hedging are taken to profit or loss. In addition, the Company's
external dividend payments, paid principally in pounds sterling and Swedish
krona, are fully hedged from announcement to payment date.
Table 17: Currency sensitivities
The Company provides the following currency-sensitivity information:
Average spot Annual impact of 5% strengthening in
FY average rate vs. USD ($m) (( 66 (#_ftn66) ))
rates vs. USD
Currency Primary Relevance FY Jan Change Total Revenue Core Operating Profit
2022 67 (#_ftn67)
2023 68 (#_ftn68)
(%)
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 (#_ftn69) )) 385 202
GBP Operating expense 0.81 0.82 (1) 46 (92)
SEK Operating expense 10.12 10.39 (3) 7 (55)
Sustainability
Since the last quarterly report, AstraZeneca:
Access to healthcare
‒ Presented the main findings of health system research conducted by
the Partnership for Health System Sustainability and Resilience (PHSSR), which
the Company co-founded, at the second Global PHSSR Summit in November. The
results highlighted key themes across workforce and health service delivery,
finance and governance, and the role of technology in strengthening health
systems, as well as the importance of prevention and early intervention in
non-communicable diseases
‒ Achieved third position overall in the 2022 Access to Medicine Index
and was recognised as the industry leader in Product Delivery, including for
its application of tailored access strategies for countries reflecting their
income classifications across all product categories. The Company's approach
to patent transparency and sharing of intellectual property assets, using
technology transfers, was also highlighted as key to ensuring continuous
supply of medicines in low- and middle-income countries. It also performed
well in the Governance of Access and Research & Development categories
‒ Chair Leif Johansson alongside Senior Executive Team members Marc
Dunoyer, Dave Fredrickson and Iskra Reic attended the World Economic Forum
(WEF) in Davos in January 2023, for engagements with global, regional and
national leaders. The Company focused on investing in health as the foundation
of strong and resilient societies, and the need for collective early action to
build more sustainable and equitable healthcare systems, including through
collaborations such as the PHSSR and Sustainable Markets Initiative (SMI).
AstraZeneca hosted a high-level roundtable on investing in non-communicable
diseases attended by global health leaders, and signed the Zero Health Gaps
Pledge in support of the WEF Global Health Equity Network vision to advance
health equity
‒ Committed to expand the Healthy Heart Africa programme into 10
countries over two years, starting in 2023, in addition to the nine countries
where the programme is currently active. Over 32 million blood pressure
screenings have been conducted since launch in 2015 and over 10,600 healthcare
workers trained, as at end of December 2022
‒ Reached more than nine million young people through the Young Health
Programme with health information and trained more than 260,000 young people
as peer educators in 39 countries, by end of December 2022
Environmental protection
‒ CEO Pascal Soriot hosted a high-level engagement on climate and
health at COP27, in his capacity as champion of the SMI Health Systems Task
Force, which made sector-first commitments, actions and recommendations to
deliver near-term targets and support the transition to net-zero sustainable
healthcare. The Company also launched new commitments during COP27 in support
of its Ambition Zero Carbon strategy
‒ Achieved a double-A rating for Climate Change and Water Security
from CDP for the seventh consecutive year, and an improved Forest score of B
for timber, B for palm oil and C for cattle products. AstraZeneca received a
CDP UK Leadership Award in recognition of the double-A rating and commitment
to environmental transparency. AZ Forest has also published a pledge
implementation update report
‒ Achieved a 100% electric vehicle fleet in the Netherlands, the first
Company location to do so, as part of the fleet decarbonisation strategy to
support Ambition Zero Carbon emissions reduction targets
‒ Earned the US Environmental Protection Agency's ENERGY STAR®
certification for superior energy efficiency for the Company's Wilmington, US
site, which is more energy-efficient than 85 percent of similar properties
nationwide
Ethics and transparency
‒ Featured in the latest Dow Jones Sustainability Index Series and the
Corporate Knights list of the Global 100 world's most sustainable corporations
‒ Marked International Day of People with Disabilities on 3 December,
which aims to promote an understanding of disability issues with an emphasis
on accessibility, including with an article on Accessibility in the workplace:
the importance of allyship, highlighting key themes such as access to
technology
‒ Featured in the 2023 Bloomberg Gender-Equality Index, for the fifth
consecutive year, recognising the Company's continued commitment to gender
equality and transparency
Research and development
This section covers R&D events and milestones that have occurred since the
prior results announcement on 10 November 2022, up to and including events on
8 February 2023.
A comprehensive view of AstraZeneca's pipeline of medicines in human trials
can be found in the latest clinical trials appendix, available on
www.astrazeneca.com/investor-relations
(https://www.astrazeneca.com/investor-relations.html) . The clinical trials
appendix includes tables with details of the ongoing clinical trials for
AstraZeneca medicines and new molecular entities in the pipeline.
Oncology
AstraZeneca presented new data across its diverse portfolio of cancer
medicines at two major medical congresses during the quarter: the 2022 San
Antonio Breast Cancer Symposium (SABCS) and the 64th American Society of
Hematology (ASH), both in December. At SABCS, AstraZeneca presented 56
abstracts spanning five approved medicines and seven pipeline medicines with
four late-breaking oral presentations. At ASH, AstraZeneca presented 47
abstracts showcasing new data across its haematology portfolio and clinical
pipeline.
Significant new trials that achieved first patient dosed during the period
included:
‒ TROPION-Breast03, a Phase III trial of datopotamab deruxtecan with
or without Imfinzi for patients with Stage I-III triple negative breast cancer
‒ AVANZAR, a Phase III trial of datopotamab deruxtecan in combination
with Imfinzi and chemotherapy for 1st-line NSCLC regardless of histology and
PD-L1 expression
Tagrisso and savolitinib
Event Commentary
Fast Track Designation US Tagrisso in combination with savolitinib for the treatment of patients with
locally advanced or metastatic NSCLC whose tumours have MET overexpression
and/or amplification, as detected by an FDA-approved test, and who have had
disease progression during or following prior Tagrisso.
Imfinzi and Imjudo (tremelimumab)
Event Commentary
Approval US Imfinzi in combination with Imjudo plus platinum-based chemotherapy for the
treatment of adult patients with Stage IV NSCLC with no sensitising EGFR 70
(#_ftn70) mutations or anaplastic lymphoma kinase. (POSEIDON, November 2022)
Approval EU Imfinzi for the 1st-line treatment of adult patients with unresectable or
metastatic BTC in combination with chemotherapy. (TOPAZ-1, December 2022)
Approval JP Imfinzi with or without Imjudo for the treatment of adult patients with
unresectable HCC. (HIMALAYA, December 2022)
Imfinzi for the treatment of adult patients with curatively unresectable BTC
in combination with chemotherapy. (TOPAZ-1, December 2022)
Imfinzi for the treatment of adult patients with unresectable, advanced or
recurrent NSCLC in combination with chemotherapy. (POSEIDON, December 2022)
Read-out PEARL Phase III trial The PEARL Phase III trial for Imfinzi did not achieve statistical significance
for the primary endpoints of improving overall survival versus platinum-based
chemotherapy as a monotherapy for the treatment of patients with Stage IV
NSCLC whose tumour cells express high levels (25% or more) of PD-L1 71
(#_ftn71) , 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 (#_ftn72) date change US The FDA indicated it will extend the PDUFA date by three months to March 2023
in order to provide further time for a full review of the sNDA 73 (#_ftn73)
for Lynparza in combination with abiraterone for the treatment of mCRPC.
(PROpel, December 2022)
Calquence
Event Commentary
Presentation: ASH Real-world evidence and long-term follow-up data Real-world evidence and long-term follow-up data support consistent efficacy
and safety profile of Calquence.
Approval JP Calquence for the treatment of adult patients with treatment-naïve chronic
lymphocytic leukaemia (ELEVATE-TN)
CHMP positive opinion EU Maleate tablet formulation
Enhertu
Event Commentary
Presentation: DESTINY-Breast03 Phase III trial Updated OS 74 (#_ftn74) results from the DESTINY-Breast03 Phase III trial,
presented at SABCS 2022, demonstrated Enhertu statistically significant and
SABCS clinically meaningful improvement in OS compared to T-DM1 75 (#_ftn75) in
patients with HER2‑positive unresectable and/or metastatic breast cancer.
DESTINY-Breast02 Phase III trial Primary results from the DESTINY-Breast02 Phase III trial demonstrated
clinical benefit of Enhertu compared to conventional chemotherapy-based
regimens in patients with HER2-positive metastatic breast cancer previously
treated with T‑DM1.
Approval EU Enhertu for patients with advanced HER2-positive gastric or gastroesophageal
junction adenocarcinoma who have received prior trastuzumab-based regimen,
based on DESTINY-Gastric02 and DESTINY-Gastric01 trials. (December 2022)
Datopotamab deruxtecan (Dato-DXd)
Event Commentary
Presentation: SABCS TROPION-PanTumor01 Phase I trial Initial results from the TROPION-PanTumor01 Phase I trial showed encouraging
and durable efficacy of Dato‑DXd in patients with heavily pre-treated
HR-positive, HER2-low or HER2-negative unresectable or metastatic breast
cancer. In this cohort, Dato-DXd demonstrated an objective response rate of
27% as assessed by blinded independent central review. All responses were
partial and 56% of patients achieved stable disease. The disease control rate
was 85% and median PFS was 8.3 months.
Updated results from the TROPION-PanTumor01 Phase I trial demonstrated
Dato‑DXd continued to demonstrate encouraging responses in patients with
heavily pretreated metastatic TNBC and disease progression following standard
treatment.
In the TNBC cohort, Dato‑DXd demonstrated an ORR 76 (#_ftn76) of 32%
including one complete response, 13 partial responses and 18 cases of stable
disease as assessed by blinded independent central review. In the overall
cohort, Dato‑DXd demonstrated median PFS of 4.4 months and median OS of 13.5
months. (December 2022)
Camizestrant
Event Commentary
Presentation: SABCS SERENA-2 Phase II trial Detailed results from the SERENA-2 Phase II trial of camizestrant,
AstraZeneca's next-generation oral selective oestrogen receptor degrader, were
presented at SABCS 2022 and demonstrated statistically significant and
clinically meaningful improvement in PFS at both 75mg and 150mg dose levels
versus Faslodex (fulvestrant) in post-menopausal patients with ER-positive
locally advanced or metastatic breast cancer, previously treated with
endocrine therapy for advanced disease.
In the overall population, camizestrant significantly reduced risk of disease
progression or death by 42% at a 75mg dose (based on HR of 0.58, 90%
confidence interval) and mPFS of 7.2 versus 3.7 months and 33% at a 150mg dose
(based on HR of 0.67, 90% confidence interval) and mPFS of 7.7 versus 3.7
months compared to Faslodex, the current SERD standard of care.
Capivasertib
Event Commentary
Presentation: SABCS CAPItello-291 Phase III trial Detailed results from the CAPItello-291 Phase III trial of capivasertib in
combination with Faslodex demonstrated a statistically significant and
clinically meaningful improvement in PFS versus placebo plus Faslodex in
patients with HR-positive, HER2-low or negative, locally advanced or
metastatic breast cancer following recurrence or progression on, or after,
endocrine therapy (with or without a CDK4/6 inhibitor).
Capivasertib in combination with Faslodex demonstrated a 40% reduction in the
risk of disease progression or death versus placebo plus Faslodex in the
overall trial population (based on a HR of 0.60, 95% confidence interval) and
median PFS 7.2 versus 3.6 months. In the AKT pathway biomarker-altered
population, which affects up to 50% of patients with advanced HR-positive
breast cancer, capivasertib plus Faslodex reduced risk of disease progression
or death by 50% versus placebo plus Faslodex.
BioPharmaceuticals - CVRM
Farxiga
Event Commentary
Approval EU Forxiga for heart failure with reduced ejection fraction to cover patients
across the full spectrum of left ventricular ejection fraction including heart
failure with mildly reduced and preserved ejection fraction. (DELIVER,
February 2023)
BioPharmaceuticals - R&I
Significant new trials in R&I initiated since the previous results
included:
‒ TILIA, a Phase III trial for tozorakimab in acute respiratory
failure in patients with viral lung infection
Tezspire
Event Commentary
Approval US, EU The Tezspire pre-filled pen for self-administration in a pre-filled,
single-use pen for patients aged 12 years and older with severe asthma.
(January, February 2023)
Airsupra (PT027)
Event Commentary
Approval US Airsupra for the as-needed treatment or prevention of bronchoconstriction and
to reduce the risk of exacerbations in people with asthma aged 18 years and
older. This is the first approval for Airsupra, formerly known as PT027.
(January 2023)
Saphnelo
Event Commentary
Orphan Drug Designation US Saphnelo for idiopathic inflammatory myopathies (including myositis), a group
of diseases in which type I interferon plays a key role. (December 2022)
Fasenra
Event Commentary
Phase III trial discontinued HUDSON Eosinophilic gastritis (EG/EGE) trial discontinued due to strategic portfolio
prioritisation. This discontinuation was not related to any safety or efficacy
findings. (January 2023)
Tozorakimab
Event Commentary
Fast Track Designation US Tozorakimab to reduce the risk of invasive mechanical ventilation,
extracorporeal membrane oxygenation or death (acute respiratory failure) in
adults hospitalised with viral lung infection and requiring supplemental
oxygen. (December)
BioPharmaceuticals - V&I
A significant new trial commenced in the period:
‒ SUPERNOVA, a PhaseI/III trial to evaluate the safety and
neutralising activity of AZD3152 for the prevention of symptomatic COVID-19 in
adults and adolescents 12 years of age or older with conditions that cause
immune impairment
SUPERNOVA was originally planned to evaluate a combination of AZD3152 and
cilgavimab, one of the two monoclonal antibodies that make up Evusheld. In
January 2023, the decision was taken to investigate AZD3152 alone, which has
been shown to neutralise all known variants to date. AstraZeneca is aiming to
make AZD3152 available as a new option for COVID-19 in the second half of
2023, subject to trial readouts and regulatory reviews.
In February 2023, AstraZeneca reached agreement with the U.S. Department of
Defense's Joint Program Executive Office for Chemical, Biological,
Radiological and Nuclear Defense (JPEO-CBRND), in collaboration with the U.S.
Department of Health and Human Services' Biomedical Advanced Research and
Development Authority (BARDA), part of the Administration for Strategic
Preparedness and Response within the U.S. Department of Health and Human
Services, via the Medical CBRN Defense Consortium (MCDC) Other Transaction
Agreement (OTA) to develop an RNA-based universal pandemic influenza prototype
vaccine. As part of the resulting prototype project, AstraZeneca could receive
up to approximately $80m over three years to develop the vaccine from
preclinical research through a Phase I/II clinical study.
Evusheld
Event Commentary
Revision to Emergency Use Authorisation US The FDA has revised Evusheld's Emergency Use Authorisation to limit the use of
Evusheld to when the combined frequency of non-susceptible SARS-CoV-2 variants
nationally in the US is ≤90%. (January 2023)
Evusheld is not currently authorised by the US FDA for pre-exposure
prophylaxis of COVID-19 (as of January 2023), due to sustained high frequency
of circulating SARS-CoV-2 variants against which Evusheld does not retain in
vitro neutralisation.
Beyfortus
Event Commentary
Regulatory submission US Nirsevimab for prevention of lower respiratory tract disease in newborns and
infants entering or during their first RSV season, and for children up to 24
months of age who remain vulnerable to severe RSV disease through their second
RSV season. (January 2023)
The FDA has indicated it will work to expedite its review. The PDUFA date is
in the third quarter of 2023.
Rare Disease
A significant new trial achieved first patient dosed during the period:
‒ ALXN1720-MG-301, a Phase III trial of gefurulimab (ALXN1720), an
anti-C5 albumin-binding humanised bispecific V(H)H antibody in gMG
Vemircopan (ALXN2050)
Event Commentary
Conference: ASH PNH monotherapy Phase II trial An oral presentation detailing interim results from a Phase II open-label
trial of vemircopan (ALXN2050) highlighted efficacy and safety data from the
treatment-naïve patient group, establishing proof-of-concept as a monotherapy
for PNH.
Vemircopan monotherapy controlled IVH as demonstrated by reduction in LDH to
<1.5xULN and prevented clinically significant EVH, demonstrated by 3.9 g/dL
increase in Hgb level and ARC reduction.
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 (88) (187)
comprehensive income
Fair value movements related to own credit risk on bonds designated as fair 2 -
value through profit or loss
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 (67) (331)
comprehensive income
Fair value movements related to own credit risk on bonds designated as fair 1 (4)
value through profit or loss
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 capital Share premium account Other reserves Retained earnings Total attributable to owners of the parent Non-controlling interests Total equity
$m $m $m $m $m $m $m
At 1 Jan 2021 328 7,971 2,024 5,299 15,622 16 15,638
Profit for the period - - - 112 112 3 115
Other comprehensive loss - - - (145) (145) - (145)
Transfer to other reserves - - 21 (21) - - -
Transactions with owners
Dividends - - - (3,882) (3,882) - (3,882)
Issue of Ordinary Shares 59 27,155 - - 27,214 - 27,214
Share-based payments charge for the period - - - 615 615 - 615
Settlement of share plan awards - - - (781) (781) - (781)
Issue of replacement Alexion share awards upon acquisition - - - 513 513 - 513
Net movement 59 27,155 21 (3,589) 23,646 3 23,649
At 31 Dec 2021 387 35,126 2,045 1,710 39,268 19 39,287
At 1 Jan 2022 387 35,126 2,045 1,710 39,268 19 39,287
Profit for the period - - - 3,288 3,288 5 3,293
Other comprehensive loss - - - (875) (875) (3) (878)
Transfer to other reserves - - 24 (24) - - -
Transactions with owners
Dividends - - - (4,485) (4,485) - (4,485)
Issue of Ordinary Shares - 29 - - 29 - 29
Share-based payments charge for the period - - - 619 619 - 619
Settlement of share plan awards - - - (807) (807) - (807)
Net movement - 29 24 (2,284) (2,231) 2 (2,229)
At 31 Dec 2022 387 35,155 2,069 (574) 37,037 21 37,058
Table 22: Condensed consolidated statement of cash flows
For the year ended 31 December 2022 2021
$m $m
Cash flows from operating activities
Profit/(loss) before tax 2,501 (265)
Finance income and expense 1,251 1,257
Share of after tax losses of associates and joint ventures 5 64
Depreciation, amortisation and impairment 5,480 6,530
Increase in trade and other receivables (1,349) (961)
Decrease in inventories 3,941 1,577
Increase in trade and other payables and provisions 1,165 1,405
Gains on disposal of intangible assets (104) (513)
Gains on disposal of investments in associates and joint ventures - (776)
Fair value movements on contingent consideration arising from business 82 14
combinations
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 (215) (211)
combinations
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 (114) 96
instruments
Payments to associates and joint ventures (26) (92)
Disposal of investments in associates and joint ventures - 776
Interest received 60 34
Net cash outflow from investing activities (2,960) (11,058)
Net cash inflow/(outflow) before financing activities 6,848 (5,095)
Cash flows from financing activities
Proceeds from issue of share capital 29 29
Issue of loans and borrowings - 12,929
Repayment of loans and borrowings (1,271) (4,759)
Dividends paid (4,364) (3,856)
Hedge contracts relating to dividend payments (127) (29)
Repayment of obligations under leases (244) (240)
Movement in short-term borrowings 74 (276)
Payments to acquire non-controlling interests - (149)
Payment of Acerta Pharma share purchase liability (920) -
Net cash (outflow)/inflow from financing activities (6,823) 3,649
Net increase/(decrease) in Cash and cash equivalents in the period 25 (1,446)
Cash and cash equivalents at the beginning of the period 6,038 7,546
Exchange rate effects (80) (62)
Cash and cash equivalents at the end of the period 5,983 6,038
Cash and cash equivalents consist of:
Cash and cash equivalents 6,166 6,329
Overdrafts (183) (291)
5,983 6,038
Notes to the Condensed Consolidated Financial Statements
Note 1: Basis of preparation and accounting policies
The Condensed Consolidated Financial Statements for the year ended 31 December
2022 have been prepared in accordance with UK-adopted International Accounting
Standards and with the requirements of the Companies Act 2006 as applicable to
companies reporting under those standards. The Condensed Consolidated
Financial Statements also comply fully with International Financial Reporting
Standards (IFRSs) as issued by the International Accounting Standards Board
(IASB) and International Accounting Standards as adopted by the European
Union.
The Condensed Consolidated Financial Statements for the year ended 31 December
2022 include Alexion's results for the period. Alexion's post-acquisition
results for 2021 were consolidated into the Group's results from 21 July 2021
therefore the respective comparative periods shown are not entirely comparable
with the current period.
These Condensed Consolidated Financial Statements comprise the financial
results of AstraZeneca PLC for the years to 31 December 2022 and 2021 together
with the Statement of financial position as at 31 December 2022 and 2021. The
results for the year to 31 December 2022 have been extracted from the 31
December 2022 audited Consolidated Financial Statements which have been
approved by the Board of Directors. These have not yet been delivered to the
Registrar of Companies but are expected to be published on 21 February 2023
within the Annual Report and Form 20-F Information 2022.
The financial information set out above does not constitute the Group's
statutory accounts for the years to 31 December 2022 or 2021 but is derived
from those accounts. The auditors have reported on those accounts: their
reports (i) were unqualified, (ii) did not include a reference to any matters
to which the auditors drew attention by way of emphasis without qualifying
their report and (iii) did not contain a statement under section 498 (2) or
(3) of the Companies Act 2006 in respect of the accounts for the year to 31
December 2022 or 31 December 2021. Statutory accounts for the year to 31
December 2022 were approved by the Board of Directors for release on 9
February 2023.
The Condensed Consolidated Financial Statements have been prepared applying
the accounting policies that were applied in the preparation of the Group's
published consolidated financial statements for the year ended 31 December
2021.
AstraZeneca has assessed the impact of the uncertainty presented by the
COVID-19 pandemic and the Russia-Ukraine conflict on the Financial Statements,
specifically considering the impact on key judgements and significant
estimates along with several other areas of increased risk. No material
accounting impacts relating to COVID-19 or the Russia-Ukraine conflict were
recognised in the year.
Going concern
The Group has considerable financial resources available. As at 31 December
2022, the Group has $11.1bn in financial resources (Cash and cash equivalent
balances of $6.2bn and undrawn committed bank facilities of $4.9bn available
until April 2026 with only $5.5bn of borrowings due within one year). All
facilities contain no financial covenants and were undrawn at 31 December
2022. On 2 February 2023, the Group entered into an additional $2.0bn of
two-year committed bank facilities.
The Group's revenues are largely derived from sales of medicines covered by
patents. which provide a relatively high level of resilience and
predictability to cash inflows, although government price interventions in
response to budgetary constraints are expected to continue to adversely affect
revenues in some of our significant markets. The Group, however, anticipates
new revenue streams from both recently launched medicines and those in
development, and the Group has a wide diversity of customers and suppliers
across different geographic areas.
Consequently, the Directors believe that, overall, the Group is well placed to
manage its business risks successfully. Accordingly, they continue to adopt
the going concern basis in preparing the Condensed Consolidated Financial
Statements.
Legal proceedings
The information contained in Note 6 updates the disclosures concerning legal
proceedings and contingent liabilities in the Group's Annual Report and Form
20-F Information 2021
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2021/pdf/AstraZeneca_AR_2021.pdf)
.
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
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2021/pdf/AstraZeneca_AR_2021.pdf)
. 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, in 2018, in response to Paragraph IV notices,
AstraZeneca initiated abbreviated new drug application (ANDA) litigation
against Zydus Pharmaceuticals (USA) Inc. (Zydus) in the US District Court for
the District of Delaware (the District Court). In May 2021, trial against
Zydus proceeded and in October 2021, the District Court issued a decision
finding the asserted claims of AstraZeneca's patent as valid and infringed by
Zydus's ANDA product. In August 2022, Zydus appealed the District Court's
decision. In November 2022, Zydus's appeal was dismissed. Additional ANDA
challenges are pending.
Imjudo
US patent proceedings
In January 2023, Bristol-Myers Squibb Co. and E.R. Squibb & Sons, LLC
filed a lawsuit in US District Court for the District of Delaware against
AstraZeneca alleging that AstraZeneca's marketing of Imjudo infringes two of
their patents.
Lokelma
US patent proceedings
As previously disclosed, in August 2022, in response to Paragraph IV notices,
AstraZeneca initiated ANDA litigation against multiple generic filers in the
US District Court for the District of Delaware. A trial has been scheduled for
March 2025.
Symbicort
US patent proceedings
As previously disclosed, AstraZeneca is involved in two ongoing ANDA patent
litigations with Mylan Pharmaceuticals Inc. (Mylan) and Kindeva Drug Delivery
L.P. (Kindeva) brought in the US District Court for the Northern District of
West Virginia (the District Court). In one of those matters, in November 2022,
the District Court determined that the asserted patent was invalid.
AstraZeneca appealed that decision to the United States Court of Appeals for
the Federal Circuit (the Federal Circuit). With respect to the other matter,
following a stipulation of infringement and validity by Mylan and Kindeva that
was subject to certain appeal issues, in December 2022, the District Court
issued a Final Judgment in favour of AstraZeneca. In December 2022, Mylan and
Kindeva appealed the Final Judgment to the Federal Circuit. Both appeals are
scheduled to be heard in March 2023.
Tagrisso
Patent proceedings outside the US
As previously disclosed, in Russia in October 2021, AstraZeneca filed a
lawsuit in the Arbitration Court of the Moscow Region (the Court) against
Axelpharm, LLC to prevent it from obtaining authorisation to market a generic
version of Tagrisso prior to the expiration of AstraZeneca's patents covering
Tagrisso. The lawsuit also names the Ministry of Health of the Russian
Federation as a third party. In March 2022, the Court dismissed the lawsuit.
In June 2022, the dismissal was affirmed on appeal. In January 2023, the
dismissal was affirmed on further appeal. AstraZeneca is considering its
option.
Lynparza
US patent proceedings
In December 2022, AstraZeneca received a Paragraph IV notice letter from an
ANDA filer relating to patents listed in the FDA Orange Book with reference to
Lynparza. AstraZeneca is reviewing the notice letter.
Product liability litigation
Byetta/Bydureon
US proceedings
As previously disclosed, Amylin Pharmaceuticals, LLC (a wholly owned
subsidiary of AstraZeneca) and AstraZeneca are among multiple defendants in
various lawsuits filed in federal and state courts involving claims of
physical injury from treatment with Byetta and/or Bydureon. The lawsuits
allege several types of injuries including pancreatic cancer and thyroid
cancer. A multidistrict litigation was established in the US District Court
for the Southern District of California (the District Court) in regard to the
alleged pancreatic cancer cases in federal courts. Further, a coordinated
proceeding has been established in Superior Court in Los Angeles, California
(the California Court) for cases in California state courts. In March and
April 2021, the District Court and the California Court respectively granted
Defendants' summary judgment motions, dismissing all cases alleging pancreatic
cancer with prejudice. All remaining claims in both courts, including those
alleging thyroid cancer, have since been dismissed. This matter is now
concluded.
Nexium and Losec/Prilosec
US proceedings
As previously disclosed, AstraZeneca is defending various lawsuits brought in
US federal and state courts involving multiple plaintiffs claiming that they
have been diagnosed with various injuries following treatment with proton pump
inhibitors (PPIs), including Nexium and Prilosec. The vast majority of these
lawsuits relate to allegations of kidney injuries. In August 2017, the pending
federal court cases were consolidated in a multidistrict litigation (MDL)
proceeding in the US District Court for the District of New Jersey for
pre-trial purposes. A bellwether trial has been scheduled for June 2023, with
subsequent bellwether trials scheduled for July and September 2023. In
addition to the MDL cases, there are cases filed in several state courts
around the US; a case that was previously set to go to trial in Delaware state
court was dismissed in October 2022.
Commercial Litigation
Anti-Terrorism Act Civil Lawsuit
As previously disclosed, in October 2017, AstraZeneca and certain other
pharmaceutical and/or medical device companies were named as defendants in a
complaint filed in US District Court for the District of Columbia (the
District Court) by US nationals (or their estates, survivors, or heirs) who
were killed or wounded in Iraq between 2005 and 2013. The plaintiffs allege
that the defendants violated the US Anti-Terrorism Act and various state laws
by selling pharmaceuticals and medical supplies to the Iraqi Ministry of
Health. In July 2020, the District Court granted AstraZeneca's and the other
defendants' motion and dismissed the lawsuit, and the plaintiffs appealed to
the DC Circuit Court of Appeals (the Appellate Court). In January 2022, a
panel of the Appellate Court reversed the dismissal and remanded the case back
to the District Court. AstraZeneca and the other defendants filed petitions
requesting en banc review by the entire Appellate Court, which were denied in
February 2023.
Employment Litigation (US)
In December 2022, AstraZeneca was served with a lawsuit filed by seven former
employees in the US District Court for the District of Delaware asserting age,
religion, and disability discrimination claims related to AstraZeneca's
COVID-19 vaccine mandate. These claims are pled on a single-plaintiff and
class action basis.
Pay Equity Litigation (US)
AstraZeneca is defending a putative class and collective action matter in the
US District Court for the Northern District of Illinois brought by three named
plaintiffs, who are former AstraZeneca pharmaceutical sales representatives.
The case involves claims under the federal and Illinois Equal Pay Acts, with
the plaintiffs alleging they were paid less than male employees who performed
substantially similar and/or equal work. The plaintiffs seek various damages
on behalf of themselves and the putative class and/or collective, including
without limitation backpay, liquidated damages, compensatory and punitive
damages, attorneys' fees, and interest. In January 2023, the District Court
granted AstraZeneca's motion to dismiss plaintiffs' complaint.
Government investigations/proceedings
Brazilian Operations Investigation (Brazil)
In May 2017, Brazilian authorities seized records and data from Alexion's
Brazil offices as part of an investigation being conducted into Alexion's
Brazilian operations. AstraZeneca cooperated with this enquiry. The prosecutor
recommended discontinuance in September 2022 after determining that there was
insufficient evidence to support a legal claim. The judicial authority
approved discontinuance of the investigation, without any further enforcement
action, in November 2022. This matter is now concluded.
Texas Qui Tam
US proceedings
In December 2022, AstraZeneca was served with an unsealed civil lawsuit
brought by a qui tam relator on behalf of the State of Texas in Texas state
court, which alleges that AstraZeneca engaged in unlawful marketing practices.
US 340B Litigations and Proceedings
US proceedings
As previously disclosed, in January 2021, AstraZeneca filed a lawsuit in US
District Court for the District of Delaware (the District Court) alleging that
an Advisory Opinion issued by the Department of Health and Human Services
violates the Administrative Procedure Act. AstraZeneca later amended its
complaint to include allegations challenging letters the US government issued
in May 2021 asserting that AstraZeneca's contract pharmacy policy violates the
340B statute. In February 2022, the District Court ruled in favour of
AstraZeneca. In January 2023, the Court of Appeals affirmed the District Court
decision.
Note 7: Subsequent events
On 9 January 2023, it was announced that AstraZeneca had entered into a
definitive agreement to acquire CinCor Pharma, Inc., a US-based clinical-stage
biopharmaceutical company, focused on developing novel treatments for
resistant and uncontrolled hypertension as well as chronic kidney disease. On
23 January 2023, AstraZeneca initiated a tender offer to acquire all of
CinCor's outstanding shares for a price of $26 per share in cash at closing,
plus a non-tradable contingent value right of $10 per share in cash payable
upon a specified regulatory submission of a baxdrostat product. Combined, the
upfront and maximum potential contingent value payments represent, if
achieved, a transaction value of approximately $1.8bn. As part of the
transaction, AstraZeneca will acquire the cash and marketable securities on
CinCor's balance sheet, which totalled approximately $522m as of 30 September
2022. The transaction is expected to close in the first quarter of 2023.
On 16 January 2023, AstraZeneca completed the acquisition of Neogene
Therapeutics Inc. AstraZeneca acquired all outstanding equity of Neogene for a
total consideration of up to $320m, on a cash and debt free basis. This
includes an initial payment of $200m on deal closing, and a further up to
$120m in both contingent milestones-based and non-contingent consideration.
On 30 January 2023, AstraZeneca completed the sale of its West Chester site in
Ohio, US, to National Resilience, Inc. On completion of the sale, the
Property, plant and equipment assets associated with this transaction of $150m
which were recorded as Assets held for sale as at 31 December 2022 have been
disposed of, with no net impact recorded in the Consolidated statement of
comprehensive income.
On 2 February 2023, the Group entered into an additional $2.0bn of two-year
committed bank facilities.
Table 25: FY 2022 - Product Sales year-on-year analysis
77 (#_ftn77)
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 (#_ftn78)
The Q4 2022 information in respect of the three months ended 31 December 2022
included in the Consolidated Financial Information has not been audited by
PricewaterhouseCoopers LLP.
World Emerging Markets US Europe Established RoW
$m Act % chg CER % chg $m Act % chg CER % chg $m % chg $m Act % chg CER % chg $m Act % chg CER % chg
Oncology 3,746 9 18 814 4 14 1,789 23 689 4 21 454 (13) 7
Tagrisso 1,342 2 12 356 10 22 535 10 245 (5) 10 206 (16) 4
Imfinzi 752 19 27 63 (4) 3 450 37 142 3 20 97 (4) 18
Lynparza 689 10 17 130 27 33 331 13 162 - 16 66 (7) 15
Calquence 588 49 53 17 n/m n/m 465 39 86 n/m n/m 20 n/m n/m
Enhertu 28 n/m n/m 17 n/m n/m - - 8 n/m n/m 3 n/m n/m
Orpathys (1) n/m n/m (1) n/m n/m - - - - - - - -
Zoladex 210 (9) 4 149 (3) 10 4 71 33 (6) 10 24 (42) (25)
Faslodex 74 (27) (14) 38 (14) (2) 1 (76) 11 (46) (38) 24 (23) (3)
Iressa 24 (32) (24) 19 (34) (26) 3 55 - (44) 21 2 (52) (44)
Arimidex 14 (57) (50) 10 (61) (56) - - - - - 4 (39) (27)
Casodex 16 (28) (16) 10 (27) (16) - - 1 n/m n/m 5 (38) (23)
Others 10 (29) (18) 6 (18) (6) - - 1 (8) (10) 3 (40) (31)
BioPharmaceuticals: CVRM 2,281 12 22 938 8 20 696 15 493 25 44 154 (11) 6
Farxiga 1,177 39 52 441 39 52 323 42 342 52 76 71 (8) 9
Brilinta 345 (1) 4 64 (11) (6) 206 16 67 (19) (6) 8 (48) (41)
Lokelma 81 50 63 6 n/m n/m 48 40 9 98 n/m 18 18 49
Roxadustat 49 65 87 49 66 87 - - - - - - - -
Andexxa 39 - 14 - - - 15 (51) 12 37 63 12 n/m n/m
Crestor 224 (13) (2) 164 (8) 4 15 (28) 11 24 42 34 (33) (18)
Seloken/Toprol-XL 157 (23) (12) 150 (24) (13) - - 4 n/m n/m 3 (23) (30)
Bydureon 73 (20) (20) - (51) (59) 66 (16) 7 (47) (38) - (49) (98)
Onglyza 52 (31) (24) 22 (20) (8) 16 (38) 9 (37) (26) 5 (36) (32)
Others 84 (13) (6) 42 (6) 6 7 (42) 32 (11) (8) 3 (13) (3)
BioPharmaceuticals: R&I 1,447 (9) (3) 341 (23) (16) 692 7 259 (23) (10) 155 (5) 10
Symbicort 620 (9) (2) 133 (13) (3) 255 (2) 137 (20) (7) 95 (2) 11
Fasenra 381 7 12 13 n/m n/m 257 10 76 2 18 35 (18) (2)
Breztri 116 59 68 21 44 66 75 59 11 n/m n/m 9 8 34
Saphnelo 48 n/m n/m - - - 46 n/m 1 n/m n/m 1 n/m n/m
Tezspire 4 n/m n/m - - - - - 2 n/m n/m 2 n/m n/m
Pulmicort 166 (33) (28) 123 (36) (32) 12 (37) 19 (19) (7) 12 (5) 11
Daliresp/Daxas 28 (52) (52) 1 (53) (49) 25 (54) 2 (39) (30) - - -
Bevespi 14 (5) (1) 1 28 46 10 (1) 3 (27) (15) - - -
Others 70 (53) (47) 49 (36) (27) 12 (20) 8 (86) (83) 1 (57) (43)
BioPharmaceuticals: V&I 1,129 (51) (44) 321 (74) (72) 226 n/m 334 (49) (40) 248 (25) (7)
Vaxzevria 85 (95) (94) 45 (96) (95) - - 40 (87) (84) - - -
Evusheld 734 n/m n/m 246 n/m n/m 217 n/m 99 50 74 172 n/m n/m
Synagis 194 (19) (3) 29 46 77 (1) n/m 90 (26) (14) 76 (21) (3)
FluMist 116 (35) (24) 1 (39) (43) 10 n/m 105 (39) (27) - (88) (86)
Rare Disease 1,816 4 10 116 (12) 2 1,149 10 349 (6) 7 202 (1) 19
Soliris 844 (22) (16) 83 (29) (12) 491 (19) 179 (26) (15) 91 (18) (4)
Ultomiris 593 52 62 4 (6) 8 365 71 134 34 53 90 23 52
Strensiq 272 24 27 10 59 48 224 29 19 (1) 13 19 (6) 16
Koselugo 58 74 77 3 n/m n/m 48 51 7 n/m n/m - - -
Kanuma 49 45 44 16 n/m n/m 21 18 10 (8) 4 2 68 n/m
Other medicines 379 (7) 7 180 1 12 32 (11) 28 (23) (19) 139 (12) 11
Nexium 300 (9) 7 131 1 13 26 (12) 9 (40) (32) 134 (13) 9
Others 79 (1) 5 49 1 8 6 (2) 19 (12) (10) 5 34 70
Total Product Sales 10,798 (6) 2 2,710 (25) (18) 4,584 19 2,152 (12) 1 1,352 (13) 6
Table 27: Collaboration Revenue
FY 2022 FY 2021
$m $m
Enhertu: alliance revenue 519 193
Tezspire: alliance revenue 79 -
Lynparza: regulatory milestones 355 -
Lynparza: sales milestones - 400
Tralokinumab: sales milestones 110 -
Vaxzevria: royalties 76 64
Other royalty income 72 74
Other Collaboration Revenue 142 145
Total 1,353 876
Table 28: Other Operating Income and Expense
FY 2022 FY 2021
$m $m
Brazikumab licence termination funding 138 99
Waltham site gain on sale and leaseback 125 -
Divestment of rights to Plendil 61 -
Divestment of Viela Bio, Inc. shareholding - 776
Crestor (Europe ex-UK and Spain) - 317
Late stage small-molecule antibiotics assets (ex-US) - 100
Other 190 200
Total 514 1,492
Other shareholder information
Financial calendar
Announcement of first quarter 2023 results
27 April 2023
Announcement of half year and second quarter 2023
results 28 July 2023
Announcement of year to date and third quarter 2023 results 9
November 2023
Dividends are normally paid as follows:
First interim: Announced with the half year results and paid
in September
Second interim: Announced with full year results and paid in March
The record date for the second interim dividend for 2022, payable on 27 March
2023, will be 24 February 2023. The ex-dividend date will be 23 February 2023.
Contacts
For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.
Addresses for correspondence
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Deutsche Bank Trust Company Americas
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db@astfinancial.com (mailto: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 (https://www.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 (http://www.astrazeneca.com/) and follow the
Company on Twitter @AstraZeneca (http://www.twitter.com/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 (#_ftnref1) 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 (#_ftnref2) 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 (#_ftnref3) Earnings per share.
4 (#_ftnref4) 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 (#_ftnref5) Cardiovascular, Renal and Metabolism.
6 (#_ftnref6) 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 (#_ftnref7) Respiratory & Immunology.
8 (#_ftnref8) The COVID-19 medicines are Vaxzevria, Evusheld, and AZD3152 -
the COVID-19 antibody currently in development.
9 (#_ftnref9) AstraZeneca is collaborating with MSD (Merck & Co., Inc.
in the US and Canada) to develop and commercialise Lynparza.
10 (#_ftnref10) Metastatic castration-resistant prostate cancer.
11 (#_ftnref11) Human epidermal growth factor receptor 2.
12 (#_ftnref12) Hepatocellular carcinoma.
13 (#_ftnref13) Non-small cell lung cancer.
14 (#_ftnref14) Mesenchymal-epithelial transition.
15 (#_ftnref15) Long-acting antibody.
16 (#_ftnref16) 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 (#_ftnref17) Volume-based procurement.
18 (#_ftnref18) Vaccines & Immune Therapies.
19 (#_ftnref19) 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 (#_ftnref20) 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 (#_ftnref21) 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 (#_ftnref22) Chronic lymphocytic leukaemia.
23 (#_ftnref23) Heart failure with preserved ejection fraction.
24 (#_ftnref24) Respiratory syncytial virus.
25 (#_ftnref25) Neuromyelitis optica spectrum disorder.
26 (#_ftnref26) Hormone receptor.
27 (#_ftnref27) US Food and Drug Administration.
28 (#_ftnref28) Imfinzi Product Sales includes sales of Imjudo, which
commenced in Q4 2022.
29 (#_ftnref29) 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 (#_ftnref30) National reimbursement drug list.
31 (#_ftnref31) France, Germany, Italy, Spain, UK.
32 (#_ftnref32) Extensive-stage small cell lung cancer.
33 (#_ftnref33) Biliary tract cancer.
34 (#_ftnref34) Poly ADP ribose polymerase.
35 (#_ftnref35) Germline (hereditary) breast cancer gene mutation.
36 (#_ftnref36) Breast cancer gene mutation.
37 (#_ftnref37) Metastatic castration resistant prostate cancer.
38 (#_ftnref38) European Medicines Agency.
39 (#_ftnref39) Bruton tyrosine kinase inhibitor.
40 (#_ftnref40) Tyrosine kinase inhibitor.
41 (#_ftnref41) Sodium-glucose cotransporter 2.
42 (#_ftnref42) Heart failure.
43 (#_ftnref43) European Society of Cardiology.
44 (#_ftnref44) American Heart Association.
45 (#_ftnref45) American College of Cardiology.
46 (#_ftnref46) Heart Failure Society of America.
47 (#_ftnref47) Heart failure with reduced ejection fraction.
48 (#_ftnref48) Type-2 diabetes.
49 (#_ftnref49) Betaloc is the brand name for Seloken in China.
50 (#_ftnref50) Inhaled corticosteroid.
51 (#_ftnref51) Long-acting beta-agonist.
52 (#_ftnref52) Interleukin-5.
53 (#_ftnref53) 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 (#_ftnref54) Fixed dose combination.
55 (#_ftnref55) 'New-to-brand' share represents a medicine's share in the
dynamic market
56 (#_ftnref56) Intravenous injection.
57 (#_ftnref57) Systemic lupus erythematosus.
58 (#_ftnref58) Complement component 5.
59 (#_ftnref59) Paroxysmal nocturnal haemoglobinuria.
60 (#_ftnref60) Atypical haemolytic uraemic syndrome.
61 (#_ftnref61) Generalised myasthenia gravis.
62 (#_ftnref62) Other Operating Income.
63 (#_ftnref63) 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 (#_ftnref64) 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 (#_ftnref65) Securities Exchange Commission.
66 (#_ftnref66) Based on best prevailing assumptions around currency
profiles.
67 (#_ftnref67) Based on average daily spot rates 1 Jan 2022 to 31 Dec 2022
68 (#_ftnref68) Based on average daily spot rates 1 Jan 2023 to 31 Jan 2023.
69 (#_ftnref69) Other currencies include AUD, BRL, CAD, KRW and RUB.
70 (#_ftnref70) Epidermal growth factor receptor.
71 (#_ftnref71) Programmed death-ligand 1.
72 (#_ftnref72) Prescription Drug User Fee Act.
73 (#_ftnref73) Supplemental new drug application.
74 (#_ftnref74) Overall survival.
75 (#_ftnref75) Ado-trastuzumab emtansine.
76 (#_ftnref76) Overall response rate.
77 (#_ftnref77) 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 (#_ftnref78) 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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