REG - AstraZeneca PLC - Final Results
08/02/2024 07:15
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RNS Number : 4058C AstraZeneca PLC 08 February 2024
AstraZeneca
8 February 2024
FY and Q4 2023 results
Strong growth and pipeline momentum with three new medicines approved since
the third quarter
Revenue and EPS summary
FY 2023 Q4 2023
% Change % Change
$m Actual CER 1 (#_ftn1) $m Actual CER
- Product Sales 43,789 2 4 11,323 5 5
- Alliance Revenue 2 (#_ftn2) 1,428 89 89 424 69 67
- Collaboration Revenue(2) 594 (1) (1) 277 75 74
Total Revenue 45,811 3 6 12,024 7 8
Total Revenue ex COVID-19 45,488 13 15 12,036 16 16
Reported EPS $3.84 81 96 $0.62 7 5
Core 3 (#_ftn3) EPS $7.26 9 15 $1.45 5 7
Financial performance for full year 2023 (Growth numbers at CER)
‒ Total Revenue $45,811m, up 6% despite a decline of $3,736m from
COVID-19 medicines 4 (#_ftn4)
‒ Excluding COVID-19 medicines, Total Revenue increased 15% and
Product Sales increased 14%
‒ Double-digit Total Revenue growth from Oncology 21%, CVRM 18%,
R&I 10%, and Rare Disease 12%
‒ Core Product Sales Gross Margin 5 (#_ftn5) of 82%, up two
percentage points, reflecting the decline in sales of lower margin COVID‑19
medicines
‒ Core Operating Margin of 32% increased by two percentage points
including the previously announced gain from an update to the contractual
relationships for Beyfortus, totalling $712m and recorded as Core Other
operating income. In the quarter, higher SG&A expense drove lower
operating margins, partly due to phasing of expenses and increased investment
in launches for Airsupra, Wainua and Truqap
‒ The Core Tax Rate for the year was 17%. In the fourth quarter, the
tax rate was negatively impacted by reviews by tax authorities, administrative
appeal processes and other adjustments, offset by a routine intragroup
reorganisation of IP, leading to a tax rate of 10% in the quarter
‒ Core EPS increased 15% to $7.26
‒ Second interim dividend declared of $1.97 per share, making a total
dividend declared for FY 2023 of $2.90 per share
‒ Total Revenue and Core EPS in FY 2024 are each expected to increase
by a low double-digit to low teens percentage at CER
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
"As AstraZeneca celebrates its 25th anniversary, we are pleased to report
another year of strong financial performance and scientific progress, with
double-digit earnings growth, and investment in exciting areas of science,
including antibody drug conjugates and cell therapies, that lay the
foundations for long-term success.
We expect another year of strong growth in 2024, driven by continued adoption
of our medicines across geographies. Our differentiated and growing portfolio
of approved medicines, global reach and rich R&D pipeline give us
confidence that we will continue to deliver industry-leading growth."
Key milestones achieved since the prior results announcement
‒ Three first approvals for new molecular entities: Truqap
(capivasertib), Wainua (eplontersen), Voydeya (danicopan)
‒ US approvals for Truqap plus Faslodex in HR-positive, HER2-negative
advanced breast cancer with biomarker alterations (CAPItello‑291), and
Wainua for ATTRv-PN (NEURO-TTRansform). China approvals for Imfinzi in mBTC
(TOPAZ-1) and Beyfortus for prevention of RSV in infants (MEDLEY/MELODY).
First approval, in Japan, for Voydeya, as an add-on therapy to Ultomiris or
Soliris for PNH with EVH (ALPHA)
‒ Enhertu granted Priority Review in the US for patients with
metastatic HER2-positive solid tumours
Guidance
The Company issues its Total Revenue and Core EPS guidance for FY 2024 at CER,
based on the average foreign exchange rates through 2023.
Total Revenue is expected to increase by a low double-digit to low teens
percentage
Core EPS is expected to increase by a low double-digit to low teens percentage
‒ Collaboration Revenue is expected to increase substantially, driven
by success-based milestones and certain anticipated transactions
‒ Other operating income is expected to decrease substantially (FY
2023 included a $241m gain on the disposal of Pulmicort Flexhaler US rights,
and a $712m one-time gain relating to updates to contractual arrangements for
Beyfortus)
‒ 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 results, 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 2024 to December 2024 were to remain at
the average rates seen in January 2024, it is anticipated that both FY 2024
Total Revenue and Core EPS would incur a low single-digit adverse impact
versus the performance at CER. The Company's foreign exchange rate sensitivity
analysis is provided in Table 19.
Investor Day
AstraZeneca will host an Investor Day on 21 May 2024.
For more information, see www.astrazeneca.com/investor-relations.html
(https://www.astrazeneca.com/investor-relations.html) .
Table 1: Key elements of Total Revenue performance in Q4 2023
% Change
Revenue type $m Actual % CER %
Product Sales 11,323 5 5 * Excluding COVID-19 medicines, Q4 2023 Product Sales increased by 14%
Alliance Revenue 424 69 67 * $281m for Enhertu (Q4 2022: $188m)
* $80m for Tezspire (Q4 2022: $37m)
* $41m for Beyfortus (Q4 2022: $nil)
Collaboration Revenue 277 75 74 * $245m Lynparza regulatory milestone (Q4 2022: $105m)
* $27m Beyfortus sales milestone (Q4 2022: $nil)
Total Revenue 12,024 7 8 * Excluding COVID-19 medicines, Q4 2023 Total Revenue increased by 16%
Therapy areas $m Actual % CER %
Oncology 4,989 23 24 * Strong performance across all key medicines and regions
CVRM( ) 2,702 18 18 * Farxiga up 36% (35% at CER), Lokelma up 38%, roxadustat up 27%, Brilinta
declined 5% (4% at CER)
R&I 1,675 13 13 * Fasenra up 10% (9% CER), Breztri up 72%. Saphnelo and Tezspire also
continue to grow rapidly, partially offset by a 16% decline in Symbicort
following entry of a generic competitor in the US in the third quarter
V&I 413 (64) (66) * $6m revenue from COVID-19 mAbs and ‑$17m for Vaxzevria, both resulting
from historic contracts (Q4 2022: $734m and $95m respectively)
* Beyfortus $122m, including $41m of Alliance Revenue for AstraZeneca's
share of gross profits outside US, $27m of Collaboration Revenue for a sales
milestone and $54m of Product Sales from product supplied to Sanofi
Rare Disease( ) 1,971 9 9 * Ultomiris up 39% (38% at CER), partially offset by decline in Soliris of
15% (13% at CER)
* Strensiq up 12% (13% at CER) and Koselugo up 46% (48% at CER) reflecting
strong patient demand
Other Medicines 274 (33) (32) * Nexium generic competition in Japan
Total Revenue 12,024 7 8
Regions inc. COVID-19 $m Actual % CER %
US 5,101 7 6
Emerging Markets 2,783 2 8
- China 1,382 16 16
- Ex-China Emerging Markets 1,401 (9) 2
Europe 2,880 25 17
Established RoW 1,259 (9) (6)
Total Revenue inc. COVID-19 12,024 7 8 * Growth rates impacted by lower sales of
COVID---19 medicines (see table below)
Regions ex. COVID-19 $m Actual % CER %
US 5,101 12 12
Emerging Markets 2,791 15 22
- China 1,382 16 16
- Ex-China Emerging Markets 1,409 14 27
Europe 2,884 33 25
Established RoW 1,259 4 8
Total Revenue ex. COVID-19 12,036 16 16
Table 2: Key elements of financial performance in Q4 2023
Metric Reported Reported change Core Core Comments 6 (#_ftn6)
change
Total Revenue $12,024m 7% Actual 8% CER $12,024m 7% Actual 8% CER * Excluding COVID-19 medicines, Q4 2023 Total Revenue increased by 16%
* See Table 1 and the Total Revenue section of this document for further
details
Product Sales Gross Margin 80% +6pp Actual +6pp CER 80% +3pp Actual +2pp CER + In the prior year period, gross margins were reduced due to inventory
write-downs and manufacturing contract terminations for Evusheld
* Variations in Product Sales Gross Margin can be expected between periods
due to product seasonality, foreign exchange fluctuations and other effects
R&D expense $3,073m 17% Actual 15% CER $2,914m 15% Actual 14% CER + Increased investment in the pipeline
* Core R&D-to-Total Revenue ratio of 24%
(Q4 2022: 23%)
+ Quarterly phasing impact
SG&A expense $5,371m 16% Actual 16% CER $4,034m 13% Actual 12% CER + Market development for recent launches and pre-launch activities
* Core SG&A-to-Total Revenue ratio of 34%
(Q4 2022: 32%)
+ Quarterly phasing impact
Other operating income and expense 7 (#_ftn7) $107m -43% Actual -42% CER $107m -17% Actual -15% CER ‒ Discontinuation of brazikumab development
Operating Margin 10% +1pp Actual +1pp CER 23% Stable * See Product Sales Gross Margin, expenses and Other operating income and
expense commentary above
Net finance expense $337m 7% Actual 3% CER $259m 5% Actual 1% CER + Higher rates on floating debt and bond issuances
+ Increased Interest expense on income tax balances
‒ Higher interest received on cash and short-term investments
Tax rate -7% +9pp Actual +13pp CER 10% Stable ‒ Intragroup purchase of intellectual property
+ Reviews by tax authorities, administrative appeals and changes to certain
deferred tax balances
* Variations in the tax rate can be expected between periods
EPS $0.62 7% Actual 5% CER $1.45 5% Actual 7% CER * Further details of differences between Reported and Core are shown in
Table 14
Table 3: Pipeline highlights since prior results announcement
Event Medicine Indication / Trial Event
Regulatory approvals and other regulatory actions Truqap HR-positive HER2-negative advanced breast cancer with biomarker alterations Regulatory approval (US)
(CAPItello-291)
Imfinzi Biliary tract cancer (TOPAZ-1) Regulatory approval (CN)
Wainua ATTRv-PN (NEURO-TTRansform) Regulatory approval (US)
Beyfortus RSV (MELODY-MEDLEY) Regulatory approval (CN)
Voydeya PNH with EVH (ALPHA) Regulatory approval (JP)
Regulatory submissions Lynparza gBRCA breast cancer (adjuvant) (OlympiA) Regulatory submission (CN)
or acceptances*
Lynparza + Imfinzi Endometrial cancer (1st-line) (DUO-E) Regulatory submission (US, EU, JP)
Enhertu HER2-expressing tumours (DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02) Regulatory submission (US), Priority Review (US)
Enhertu HER2+/HER2-low gastric (1st-line) (DESTINY-Gastric01) Regulatory submission (CN)
Imfinzi + Imjudo NSCLC (neoadjuvant) (AEGEAN) Regulatory submission (EU)
Wainua ATTRv-PN (NEURO-TTRansform) Regulatory submission (EU)
Fasenra EGPA (MANDARA) Regulatory submission (US, EU, JP)
Ultomiris NMOSD (CHAMPION-NMOSD) Regulatory submission (US)
Ultomiris gMG Regulatory submission (CN)
Major Phase III data readouts and other developments Imfinzi NSCLC (unresectable, Stg. III) (PACIFIC-2) Primary endpoint not met
acoramidis 8 (#_ftn8) ATTR-CM Primary endpoint met
*US, EU and China regulatory submission denotes filing acceptance
Upcoming pipeline catalysts
For a table of anticipated timings of key trial readouts, please refer to page
3 of the Clinical Trials Appendix, available on
www.astrazeneca.com/investor-relations.html
(https://www.astrazeneca.com/investor-relations.html) .
Table 4: Phase III trials started since 1 January 2023
Medicine Trial name Indication
datopotamab deruxtecan AVANZAR NSCLC (1st-line)
TROPION-Lung07 Non-squamous NSCLC (1st-line)
TROPION-Breast04 Neoadjuvant/adjuvant triple-negative or HR-low/HER2-negative breast cancer
TROPION-Breast05 PD-L1-positive locally recurrent inoperable or metastatic TNBC
camizestrant CAMBRIA-1 HR-positive/HER2-negative adjuvant breast cancer
CAMBRIA-2 HR-positive/HER2-negative adjuvant breast cancer
Truqap CAPItello-292 HR-positive/HER2-negative advanced breast cancer
volrustomig eVOLVE-Cervical High-risk locally advanced cervical cancer
eVOLVE-Lung02 mNSCLC (1st-line) with PD-L1 <50%
eVOLVE-Meso Unresectable malignant pleural mesothelioma (1st-line)
eVOLVE-HNSCC Unresected, locally advanced HNSCC
rilvegostomig ARTEMIDE-Biliary01 BTC with curative intent
saruparib EvoPAR-PR01 HRRm and Non-HRRm mCSPC
zibo/dapa ZENITH High Proteinuria CKD with high proteinuria
Saphnelo DAISY Systemic sclerosis
baxdrostat BaxHTN Uncontrolled, including treatment-resistant, hypertension
Tezspire CROSSING Eosinophilic oesophagitis
Breztri LITHOS Mild to moderate asthma
ATHLOS COPD
pMDI portfolio HFO1234ze + Breztri COPD
HFO1234ze Mucociliary clearance in healthy volunteers
HFO1234ze Asthma
tozorakimab MIRANDA COPD
ipavibart (AZD3152) SUPERNOVA COVID-19 prophylaxis
Ultomiris ARTEMIS Cardiac surgery-associated acute kidney injury
ALXN2220 DepleTTR-CM Transthyretin amyloid cardiomyopathy
efzimfotase alfa (ALXN1850) HICKORY Hypophosphatasia
Corporate and business development
In November 2023, AstraZeneca launched Evinova, with an ambition to become a
leading provider of digital health solutions to better meet the needs of
healthcare professionals, regulators and patients. Evinova will prioritise
bringing to market established and scaled digital technology solutions already
being used globally by AstraZeneca to optimise clinical trial design and
delivery. Globally-leading clinical research organisations Parexel and Fortrea
have entered into agreements to offer Evinova digital health solutions to
their wide customer base.
In December 2023, AstraZeneca entered into a definitive agreement to acquire
Icosavax, Inc (Icosavax). The acquisition strengthens AstraZeneca's late-stage
pipeline with Icosavax's lead investigational vaccine candidate, IVX-A12, a
potential first-in-class, Phase III-ready, combination VLP vaccine that
targets both RSV and hMPV. RSV and hMPV are both leading causes of severe
respiratory infection and hospitalisation in adults 60 years of age and older
and those with chronic conditions such as cardiovascular, renal and
respiratory disease. Subject to the satisfaction of the conditions in the
merger agreement, the acquisition is expected to close in the first quarter of
2024.
In December 2023, AstraZeneca entered into a definitive agreement to acquire
Gracell Biotechnologies Inc. (Gracell), a global clinical-stage
biopharmaceutical company developing innovative cell therapies for the
treatment of cancer and autoimmune diseases. The proposed acquisition will
enrich AstraZeneca's growing pipeline of cell therapies with GC012F, a novel,
clinical-stage FasTCAR-enabled BCMA and CD19 dual-targeting CAR-T therapy, a
potential new treatment for multiple myeloma, as well as other haematologic
malignancies and autoimmune diseases including systemic lupus erythematosus.
The transaction is expected to close in the first quarter of 2024, subject to
customary closing conditions, including regulatory clearances, and Gracell
shareholder approval.
In February 2024, AstraZeneca announced that it is investing $300 million in a
state-of-the-art facility in Rockville, Maryland to establish life-saving cell
therapy platforms for critical cancer trials and future commercial supply. To
align with clinical trial timelines, the site will initially focus on pivotal
clinical trial manufacturing of CAR-T cell therapies to meet current clinical
supply demand. More than 150 new highly skilled jobs will be created to
initially focus on manufacturing T-cell therapies to enable clinical trials to
be conducted around the world. Over time, the site may expand its focus to
support other therapy areas.
Sustainability highlights
Through the Sustainable Markets Initiative Health Systems Task Force,
AstraZeneca announced an industry-first renewable power agreement in China
together with four global healthcare leaders and renewable energy company
Envision Energy, resulting in potential annual emissions savings of
approximately 120,000 tonnes, the equivalent of taking 25,000 cars off the
road. See the Sustainability section in this document for further details.
Conference call
A conference call and webcast for investors and analysts will begin today, 8
February 2024, at 11:45 UK time. Details can be accessed via astrazeneca.com
(https://www.astrazeneca.com/) .
Reporting calendar
The Company intends to publish its Q1 2024 results on 25 April 2024.
Operating and financial review
All narrative on growth and results in this section is based on actual
exchange rates, and financial figures are in US$ millions ($m), unless stated
otherwise. Unless stated otherwise, the performance shown in this announcement
covers the twelve-month period to 31 December 2023 ('the year' or 'FY 2023')
compared to the twelve-month period to 31 December 2022 (FY 2022), or the
three-month period to 31 December 2023 ('the quarter' or 'Q4 2023') compared
to the three-month period to 31 December 2022 ('Q4 2022'). References to
'first quarter', 'second quarter', 'third quarter' and fourth quarter' refer
to the respective quarters in FY 2023.
Core financial measures, EBITDA, Net debt, Product Sales Gross Margin
(formerly termed as 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:
‒ Charges and provisions related to restructuring programmes, which
includes charges that relate to the impact of restructuring programmes on
capitalised IT assets
‒ Amortisation and impairment of intangible assets, including
impairment reversals but excluding any charges relating to 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 charges and
fair value movements relating to contingent consideration on business
combinations, imputed finance charges and remeasurement adjustments on certain
Other payables arising from intangible asset acquisitions, legal settlements
and remeasurement adjustments relating to Other payables assumed from the
Alexion acquisition
‒ 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 63 of
the Annual Report and Form 20-F Information 2022
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2022/pdf/AstraZeneca_AR_2022.pdf)
.
Reference should be made to the Reconciliation of Reported to Core financial
measures table included in the financial performance section in this
announcement.
Product Sales Gross Margin (formerly termed Gross Margin) is calculated by
dividing the difference between Product Sales and Cost of Sales by the Product
Sales. The calculation of Reported and Core Product Sales Gross Margin
excludes the impact of Alliance Revenue and 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.
Operating margin is defined as Operating profit as a percentage of Total
Revenue.
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 5: Therapy area and medicine performance - Product Sales and Total
Revenue
FY 2023 Q4 2023
% Change % Change
Product Sales $m % Total Actual CER $m % Total Actual CER
Oncology 17,145 37 17 20 4,453 37 19 19
- Tagrisso 5,799 13 7 9 1,419 12 6 6
- Imfinzi 9 (#_ftn9) 4,237 9 52 55 1,135 9 51 52
- Lynparza 2,811 6 7 9 741 6 8 8
- Calquence 2,514 5 22 23 675 6 15 14
- Enhertu 261 1 >3x >3x 83 1 >2x >3x
- Orpathys 44 - 34 42 11 - n/m n/m
- Truqap 6 - n/m n/m 6 - n/m n/m
- Zoladex 952 2 3 9 254 2 20 23
- Faslodex 297 1 (11) (6) 79 1 7 7
- Others 224 - (33) (30) 50 - (22) (19)
BioPharmaceuticals: CVRM 10,585 23 15 18 2,698 22 18 18
- Farxiga 5,963 13 36 39 1,606 13 36 35
- Brilinta 1,324 3 (2) (1) 329 3 (5) (4)
- Lokelma 412 1 43 46 112 1 38 38
- roxadustat 271 1 38 45 63 1 28 28
- Andexxa 182 - 21 23 53 - 35 34
- Crestor 1,107 2 6 11 247 2 10 12
- Seloken/Toprol-XL 640 1 (26) (20) 144 1 (8) (3)
- Onglyza 227 - (12) (8) 47 - (9) (7)
- Bydureon 163 - (42) (42) 39 - (46) (47)
- Others 296 1 (19) (17) 58 - (30) (31)
BioPharmaceuticals: R&I 6,107 13 6 8 1,590 13 10 10
- Symbicort 2,362 5 (7) (4) 520 4 (16) (16)
- Fasenra 1,553 3 11 12 420 3 10 9
- Breztri 677 1 70 73 199 2 72 72
- Saphnelo 280 1 >2x >2x 89 1 86 86
- Tezspire 86 - >10x >10x 35 - >9x >8x
- Pulmicort 713 2 11 17 219 2 32 40
- Bevespi 58 - - - 15 - 6 4
- Daliresp/Daxas 54 - (72) (72) 13 - (56) (55)
- Others 324 1 (23) (20) 80 1 13 14
BioPharmaceuticals: V&I 1,012 2 (79) (78) 345 3 (69) (70)
- COVID-19 mAbs 132 - (94) (93) 6 - (99) (99)
- Vaxzevria 12 - (99) (99) (17) - n/m n/m
- Beyfortus 106 - n/m n/m 54 - n/m n/m
- Synagis 546 1 (6) (2) 164 1 (16) (16)
- FluMist 216 - 24 17 138 1 20 11
Rare Disease 7,764 17 10 12 1,971 16 9 9
- Soliris 3,145 7 (16) (14) 715 6 (15) (13)
- Ultomiris( ) 2,965 6 51 52 825 7 39 38
- Strensiq( ) 1,152 3 20 21 305 3 12 13
- Koselugo 331 1 59 60 85 1 46 48
- Kanuma( ) 171 - 7 8 41 - (17) (14)
Other medicines 1,176 3 (28) (24) 266 2 (30) (28)
- Nexium 945 2 (27) (22) 209 2 (30) (28)
- Others 231 1 (32) (30) 57 - (28) (27)
Product Sales 43,789 96 2 4 11,323 94 5 5
Alliance Revenue 1,428 3 89 89 424 4 69 67
Collaboration Revenue 594 1 (1) (1) 277 2 75 74
Total Revenue 45,811 100 3 6 12,024 100 7 8
Table 6: Alliance Revenue
FY 2023 Q4 2023
% Change % Change
$m % Total Actual CER $m % Total Actual CER
Enhertu 1,022 72 95 95 281 66 50 47
Tezspire 259 18 >3x >3x 80 19 >2x >2x
Beyfortus 57 4 n/m n/m 41 10 n/m n/m
Vaxzevria: royalties - - n/m n/m - - n/m n/m
Other royalty income 81 6 18 18 21 5 25 27
Other Alliance Revenue 9 1 6 9 1 - >3x >3x
Total 1,428 100 89 89 424 100 69 67
Table 7: Collaboration Revenue
FY 2023 Q4 2023
% Change % Change
$m % Total Actual CER $m % Total Actual CER
Lynparza: regulatory milestones 245 41 (31) (31) 245 88 >2x >2x
COVID-19 mAbs: licence fees 180 30 n/m n/m - - - -
Farxiga: sales milestones 29 5 n/m n/m 1 - n/m n/m
tralokinumab: sales milestones 20 3 (82) (82) - - - -
Beyfortus: regulatory milestones 71 12 >2x >2x - - n/m n/m
Beyfortus: sales milestone 27 5 n/m n/m 27 10 n/m n/m
Other Collaboration Revenue 22 4 (52) (52) 4 1 (88) (89)
Total 594 100 (1) (1) 277 100 75 74
Table 8: Total Revenue by therapy area
FY 2023 Q4 2023
% Change % Change
$m % Total Actual CER $m % Total Actual CER
Oncology 18,447 40 19 21 4,989 41 23 24
BioPharmaceuticals 18,389 40 (8) (6) 4,790 40 (3) (3)
- CVRM 10,628 23 15 18 2,702 22 18 18
- R&I 6,404 14 7 10 1,675 14 13 13
- V&I 1,357 3 (72) (71) 413 3 (64) (66)
Rare Disease 7,764 17 10 12 1,971 16 9 9
Other Medicines 1,211 3 (31) (27) 274 2 (33) (32)
Total 45,811 100 3 6 12,024 100 7 8
Table 9: Total Revenue by region
FY 2023 Q4 2023
% Change % Change
$m % Total Actual CER $m % Total Actual CER
US 19,077 42 6 6 5,101 42 7 6
Emerging Markets 12,025 26 2 9 2,783 23 2 8
- China 5,876 13 1 7 1,382 11 16 16
- Ex-China 6,148 13 3 11 1,401 12 (9) 2
Europe 9,611 21 10 8 2,880 24 25 17
Established RoW 5,099 11 (14) (8) 1,259 10 (9) (6)
Total 45,811 100 3 6 12,024 100 7 8
Table 10: Total Revenue by region - excluding COVID-19 medicines
FY 2023 Q4 2023
% Change % Change
$m % Total Actual CER $m % Total Actual CER
US 19,077 42 14 14 5,101 42 12 12
Emerging Markets 11,830 26 12 20 2,791 23 15 22
- China 5,876 13 2 8 1,382 11 16 16
- Ex-China 5,953 13 24 35 1,409 12 14 27
Europe 9,597 21 19 17 2,884 24 33 25
Established RoW 4,985 11 1 8 1,259 10 4 8
Total 45,488 100 13 15 12,036 100 16 16
Oncology
Oncology Total Revenue of $18,447m in FY 2023 increased by 19% (21% at CER),
representing 40% of overall Total Revenue (FY 2022: 35%). Lynparza
Collaboration Revenue was $245m in FY 2023 (FY 2022: $355m) reflecting
achievement of regulatory milestone for the US approval of PROpel and Enhertu
Alliance Revenue was $1,022m (FY 2022: $523m). Product Sales increased by 17%
(20% at CER) in FY 2023 to $17,145m, reflecting new launches and expanded
reimbursement across key brands; partially offset by declines in legacy
medicines.
Tagrisso
Total Revenue Worldwide US Emerging Markets Europe Established RoW
FY 2023 $m 5,799 2,276 1,621 1,120 782
Actual change 7% 13% 3% 10% (8%)
CER change 9% 13% 10% 8% (1%)
Region Drivers and commentary
Worldwide * Increased global demand for Tagrisso in adjuvant (ADAURA) and 1st -line
setting (FLAURA)
US * Continued adjuvant and 1st-line demand growth
Emerging Markets * Continued demand growth, partly offset by anticipated seasonality from
hospital ordering dynamic in China
Europe * Continued growth in 1st-line setting and increasing adjuvant demand
Established RoW * Increased demand in adjuvant and 1st-line offset by continued impacts
from HSR price reduction in Japan effective June 2023 and reclassification of
Australian government rebates from Q4 2023
Imfinzi and Imjudo
Total Revenue Worldwide US Emerging Markets Europe Established RoW
FY 2023 $m 4,237 2,317 360 758 802
Actual change 52% 49% 25% 39% >2x
CER change 55% 49% 39% 36% >2x
Region Drivers and commentary
Worldwide * Includes $218m of Total Revenue from Imjudo, which launched in Q4 2022
following approvals in the US for patients with unresectable HCC (HIMALAYA)
and Stage IV NSCLC (POSEIDON)
US * Continued demand growth from new launches in GI, including BTC (TOPAZ-1)
and HCC
Emerging Markets * Increased demand for new launches including BTC as well as continued
demand for legacy indications: Stage III unresectable NSCLC (PACIFIC), SCLC
(CASPIAN)
Europe * Competitive share gain in SCLC and expanded reimbursement for BTC, HCC,
Stage IV NSCLC and SCLC
Established RoW * Growth driven by launch of BTC, HCC and Stage IV NSCLC in Japan
Lynparza
Total Revenue Worldwide US Emerging Markets Europe Established RoW
FY 2023 $m 3,056 1,254 542 979 281
Actual change 2% 2% 11% (3%) 5%
CER change 4% 2% 21% (4%) 12%
Product Sales Worldwide US Emerging Markets Europe Established RoW
FY 2023 $m 2,811 1,254 542 734 281
Actual change 7% 2% 11% 12% 5%
CER change 9% 2% 21% 10% 12%
Region Drivers and commentary
Worldwide * Lynparza remains the leading medicine in the PARP inhibitor class
globally across four tumour types (ovarian, breast, prostate, pancreatic), as
measured by total prescription volume
* Following achievement of the regulatory approval for Lynparza PROpel in
the US, AstraZeneca recognised $245m in milestone-related income from MSD in
Q4 2023
US * Continued share growth within PARP inhibitor class, offset by declining
class use following the label restriction in 2nd-line ovarian cancer effective
September 2023
Emerging Markets * Increased demand, offset by price reduction in China associated with
NRDL renewal that took effect March 2023 for ovarian cancer indications (PSR
and BRCAm 1st-line maintenance) and new NRDL enlistment in prostate cancer
(PROfound)
Europe * Demand growth from increased uptake and new launches in 1st-line
HRD-positive ovarian cancer (PAOLA-1), gBRCAm HER2‑negative early breast
cancer (OlympiA) and mCRPC (PROpel), offset by reduced use in 2nd-line ovarian
cancer and pricing
Established RoW * Growth driven by increased uptake in biomarker testing and use in
1st-line HRD-positive ovarian cancer, partially offset by market expansion
re-pricing in Japan from November 2023
Enhertu
Total Revenue Worldwide US Emerging Markets Europe Established RoW
FY 2023 $m 1,283 702 254 296 32
Actual change >2x 73% >3x >2x >4x
CER change >2x 73% >3x >2x >4x
Region Drivers and commentary
Worldwide * Combined sales of Enhertu, recorded by Daiichi Sankyo Company Limited
(Daiichi Sankyo) and AstraZeneca, amounted to $2,566m in FY 2023 (FY 2022:
$1,253m)
* AstraZeneca's Total Revenue of $1,283m in the period includes $1,022m of
Alliance Revenue from its share of gross profits and royalties in territories
where Daiichi Sankyo records product sales
US * US in-market sales, recorded by Daiichi Sankyo, amounted to $1,472m in
FY 2023 (FY 2022: $850m)
* Increased demand across launched indications offset by HER2-low bolus
depletion in H2 2023
Emerging Markets * Continued uptake driven by approvals and launches including strong
demand growth in China following HER2-positive (DESTINY-Breast03) and HER2-low
(DESTINY-Breast04) metastatic breast cancer launches
Europe * Continued growth driven by increasing adoption in HER2-positive and
HER2-low metastatic breast cancer
Established RoW * AstraZeneca's Alliance Revenue includes a mid-single-digit percentage
royalty on Daiichi Sankyo's sales in Japan
Calquence
Total Revenue Worldwide US Emerging Markets Europe Established RoW
FY 2023 $m 2,514 1,815 98 493 108
Actual change 22% 10% >2x 72% 58%
CER change 23% 10% >2x 69% 65%
Region Drivers and commentary
Worldwide * Increased penetration globally; leading BTK inhibitor across key markets
US * Sustained BTK inhibitor leadership across front-line and relapsed
refractory CLL, partly offset by continued gross-to-net pressure within
competitive class
Europe * Continued growth supported by expanded access in key markets
Truqap
Truqap was approved in the US on 16 November 2023 in HR-positive HER2-negative
metastatic breast cancer with one or more biomarker alterations
(CAPItello-291) and regulatory submissions in other markets are ongoing.
Strong initial launch demand resulted in $6m of Total Revenue in Q4 2023.
Other Oncology medicines
FY 2023 Change
Total Revenue $m Actual CER
Zoladex 986 3% 9% * Strong underlying growth in China and Emerging Markets offset by flat
performance in EU and drop in Japan
* Australian government rebate reclassifications from Q4 2023
Faslodex 297 (11%) (6%) * Decline in China sales in fourth quarter due to supply issues, a
consequence of short lead time of supply replenishment following VBP timeline
changes
Orpathys 46 37% 44% * Included in the NRDL in China from March 2023, for the treatment of
patients with NSCLC with MET exon 14 skipping alterations
Other Oncology 224 (33%) (30%) * Generic competition
BioPharmaceuticals
BioPharmaceuticals Total Revenue decreased by 8% (6% at CER) in FY 2023 to
$18,389m, representing 40% of overall Total Revenue (FY 2022: 45%). The
decline was driven by COVID-19 medicines, partially offset by strong growth
from Farxiga and R&I medicines.
BioPharmaceuticals - CVRM
CVRM Total Revenue increased by 15% (18% at CER) to $10,628m in FY 2023 and
represented 23% of overall Total Revenue (FY 2022: 21%).
Farxiga
Total Revenue Worldwide US Emerging Markets Europe Established RoW
FY 2023 $m 5,997 1,451 2,214 1,881 451
Actual change 37% 35% 33% 45% 28%
CER change 39% 35% 40% 42% 37%
Region Drivers and commentary
Worldwide * Farxiga volume is growing faster than the overall SGLT2 market in most
major regions, fuelled by launches in heart failure and CKD
* Additional benefit from continued growth in the overall SGLT2 inhibitor
class
US * Growth driven by heart failure and CKD for patients with and without
type 2 diabetes resulting in an increased market share. Favourable
gross-to-net adjustment in Q4 2023
Emerging Markets * Solid growth despite generic competition in some markets and strong
momentum in Latin America, among other markets
Europe * Benefited from the addition of cardiovascular outcomes trial data to the
label and growth in HFrEF, CKD and the HFpEF approval in February 2023
* ESC guidelines updated in August 2023 to also include treatment of
patients with HFpEF
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, largely offset by
generic launches in Canada in Q3 2023
Brilinta
Total Revenue Worldwide US Emerging Markets Europe Established RoW
FY 2023 $m 1,324 744 285 271 24
Actual change (2%) - - (4%) (49%)
CER change (1%) - 10% (5%) (47%)
Region Drivers and commentary
US * Flat sales but with volume growth driven by longer duration of treatment
Emerging Markets * Holding market position despite generics pressure
Europe * Sales partly impacted by clawbacks
Established RoW * Sales decline driven by generic entry in Canada
Lokelma
Lokelma Total Revenue increased 43% (46% at CER) to $412m with strong demand
growth in all regions.
Roxadustat
Total Revenue increased 37% (44% at CER) to $276m, benefitting from increased
demand in both the dialysis and non-dialysis-dependent populations. NRDL
listing renewed.
Andexxa
Andexxa Total Revenue increased 14% (15% at CER) to $182m.
Other CVRM medicines
FY 2023 Change
Total Revenue $m Actual CER
Crestor 1,110 6% 12% * Continued sales growth in Emerging Markets
Seloken/Toprol-XL 641 (26%) (20%) * Ongoing impact of China VBP implementation
Onglyza 227 (12%) (8%) * Continued decline for DPP-IV class
Bydureon 163 (42%) (42%) * Continued competitive pressures
Other CVRM 296 (19%) (17%)
BioPharmaceuticals - R&I
Total Revenue of $6,404m from R&I medicines in FY 2023 increased 7% (10%
at CER) and represented 14% of overall Total Revenue (FY 2022: 13%). This
reflected growth in Fasenra, Tezspire, Breztri and Saphnelo, offsetting a
decline in Symbicort.
Fasenra
Total Revenue Worldwide US Emerging Markets Europe Established RoW
FY 2023 $m 1,553 992 64 355 142
Actual change 11% 9% 50% 16% -
CER change 12% 9% 61% 14% 6%
Region Drivers and commentary
Worldwide * Continued asthma market share leadership in IL-5 class across major
markets
US * Maintained share of a growing market, leading to strong volume
growth
Emerging Markets * Continued strong demand growth driven by launch acceleration across key
markets
Europe * Expanded leadership in severe eosinophilic asthma
Established RoW * Continued class leadership in Japan
Breztri
Total Revenue Worldwide US Emerging Markets Europe Established RoW
FY 2023 $m 677 383 161 81 52
Actual change 70% 60% 75% >2x 55%
CER change 73% 60% 85% >2x 66%
Region Drivers and commentary
Worldwide * Fastest growing medicine within the growing FDC triple class across
major markets
US * Consistent share growth within the FDC triple class in new-to-brand 10
(#_ftn10) and the total market
Emerging Markets * Maintained market share leadership in China with strong triple FDC class
penetration
Europe * Sustained growth across markets as new launches continue to progress
Established RoW * Increased market share within COPD in Japan and strong launch in
Canada
Tezspire
Total Revenue Worldwide US Emerging Markets Europe Established RoW
FY 2023 $m 345 261 1 46 37
Actual change >4x >3x >6x >10x >10x
CER change >4x >3x >5x >10x >10x
Region Drivers and commentary
Worldwide * Combined sales of Tezspire, recorded by Amgen and AstraZeneca, amounted
to $653m in FY 2023 (FY 2022: $174m)
* AstraZeneca's Total Revenue of $345m in the period includes $259m of
Alliance Revenue from its share of gross profits in the US, where Amgen
records product sales
US * Maintained new-to-brand market share with majority of patients new to
biologics
* Pre-filled pen approved in February 2023
Europe * Achieved new-to-brand leadership in key markets
* Pre-filled pen approved in January 2023
Established RoW * Japan maintained new-to-brand leadership
Saphnelo
Total Revenue Worldwide US Emerging Markets Europe Established RoW
FY 2023 $m 280 260 2 8 10
Actual change >2x >2x n/m >4x >2x
CER change >2x >2x n/m >4x >3x
Region Drivers and commentary
Worldwide * Demand acceleration in the US, and additional growth driven by ongoing
launches in Europe and Japan
Symbicort
Total Revenue Worldwide US Emerging Markets Europe Established RoW
FY 2023 $m 2,362 726 753 549 334
Actual change (7%) (25%) 24% (6%) (11%)
CER change (4%) (25%) 33% (7%) (7%)
Region Drivers and commentary
Worldwide * Symbicort remained the global market leader within a stable ICS/LABA
class
US * Generic competition entered the US market in the third quarter of 2023
Emerging Markets * Strong underlying demand for Symbicort in both China and Ex-China
Emerging Markets, strengthened position as market leader in the region
Europe * Continued price and volume erosion from generics and a slowing overall
market
Established RoW * Continued generic erosion in Japan
Other R&I medicines
FY 2023 Change
Total Revenue $m Actual CER
Pulmicort 713 11% 17% * >80% of revenues from Emerging Markets
* China market share has stabilised, with VBP having been in effect for
over 12 months
Bevespi 58 - -
Daliresp/Daxas 54 (72%) (72%) * Impacted by uptake of multiple generics following loss of exclusivity in
the US
Other R&I 362 (33%) (30%) * Collaboration Revenue of $20m (FY 2022: $110m)
* Product Sales of $324m decreased 23% (20% at CER) due to generic
competition
BioPharmaceuticals - V&I
Total Revenue from V&I medicines declined by 72% (71% at CER) to $1,357m
(FY 2022: $4,836m) and represented 3% of overall Total Revenue (FY 2022: 11%).
The decline was driven by COVID-19 medicines, which generated $323m of Total
Revenue in FY 2023 (FY 2022: $4,059m).
COVID-19 mAbs
Total Revenue Worldwide US Emerging Markets Europe Established RoW
FY 2023 $m 312 - 186 12 114
Actual change (86%) n/m (55%) (96%) (72%)
CER change (85%) n/m (55%) (96%) (68%)
Region Drivers and commentary
Worldwide * All Product Sales in FY 2023 were derived from sales of Evusheld
Emerging Markets * $180m license fee from Serum Institute of India in Q2 2023 recorded as
Collaboration Revenue
Vaxzevria
Total Revenue Worldwide US Emerging Markets Europe Established RoW
FY 2023 $m 11 - 10 2 -
Actual change (99%) n/m (99%) n/m n/m
CER change (99%) n/m (99%) (99%) n/m
Other V&I medicines
FY 2023 Change
Total Revenue $m Actual CER
Beyfortus 262 >10x >10x * In Q4 2023 AstraZeneca reported $54m of Product Sales, $41m of Alliance
Revenue, and also $27m of Collaboration Revenue relating to a sales milestone
* Product Sales recognises AstraZeneca's sales of manufactured Beyfortus
product to Sanofi
* Alliance Revenue recognises AstraZeneca's 50% share of gross profits on
sales of Beyfortus in major markets outside the US
* AstraZeneca will recognise 25% of brand revenues in rest of world
markets
* AstraZeneca has no participation in US profits or losses
Synagis 546 (6%) (2%) * Performance broadly in-line with prior year
FluMist 226 30% 22% * $10m milestone received from Daiichi Sankyo in the second quarter of
2023 following FluMist approval in Japan
Rare Disease
Total Revenue from Rare Disease medicines increased by 10% (12% at CER) in FY
2023 to $7,764m, representing 17% of overall Total Revenue (FY 2022: 16%).
Ultomiris
Total Revenue Worldwide US Emerging Markets Europe Established RoW
FY 2023 $m 2,965 1,750 71 668 476
Actual change 51% 54% 88% 39% 54%
CER change 52% 54% 89% 36% 65%
Region Drivers and commentary
Worldwide * Continued growth across gMG as well as expansion into new markets and
continued conversion from Soliris
* Quarter-on-quarter variability in revenue growth can be expected due to
Ultomiris every eight-week dosing schedule and lower average annual treatment
cost compared to Soliris
US * Growth in naïve patients in gMG as well as successful conversion from
Soliris across shared indications
Emerging Markets * Continued growth following launches in new markets
Europe * Strong demand generation following launches in new markets, particularly
in neurology indications, as well as accelerated conversion from Soliris in
key markets, partially offset by price reductions to secure reimbursement
for new indications
Established RoW * Continued conversion from Soliris and strong demand following new
launches
Soliris
Total Revenue Worldwide US Emerging Markets Europe Established RoW
FY 2023 $m 3,145 1,734 424 670 317
Actual change (16%) (20%) 41% (17%) (33%)
CER change (14%) (20%) 63% (18%) (29%)
Region Drivers and commentary
US * Decline driven by successful conversion of Soliris patients to Ultomiris
in PNH, aHUS and gMG, partially offset by Soliris growth in NMOSD
Emerging Markets * Growth driven by patient demand following launches in new markets
Europe * Decline driven by successful conversion from Soliris to Ultomiris as
well as biosimilar erosion in PNH
Est. RoW * Decline driven by successful conversion from Soliris to Ultomiris
Strensiq
Total Revenue Worldwide US Emerging Markets Europe Established RoW
FY 2023 $m 1,152 937 40 89 86
Actual change 20% 22% 15% 14% 13%
CER change 21% 22% 22% 11% 22%
Region Drivers and commentary
Worldwide * Growth driven by strong patient demand
Other Rare Disease medicines
FY 2023 Change
Total Revenue $m Actual CER Commentary
Koselugo 331 59% 60% * Driven by patient demand and expansion in new markets
Kanuma 171 7% 8% * Continued demand growth in ex-US markets
Other medicines (outside the main therapy areas)
FY 2023 Change
Total Revenue $m Actual CER Commentary
Nexium 962 (30%) (26%) * Generic launches in Japan in the latter part of 2022
Others 249 (35%) (33%) * Continued impact of generic competition
Financial performance
Table 11: Reported Profit and Loss
FY 2023 FY 2022 % Change Q4 2023 Q4 2022 % Change
$m $m Actual CER $m $m Actual CER
Total Revenue 45,811 44,351 3 6 12,024 11,207 7 8
- Product Sales 43,789 42,998 2 4 11,323 10,798 5 5
- Alliance Revenue 1,428 755 89 89 424 251 69 67
- Collaboration Revenue 594 598 (1) (1) 277 158 75 74
Cost of sales (8,268) (12,391) (33) (34) (2,308) (2,900) (20) (18)
Gross profit 37,543 31,960 17 21 9,716 8,307 17 16
Product Sales Gross Margin 81.1% 71.2% +10pp +10pp 79.6% 73.1% +6pp +6pp
Distribution expense (539) (536) 1 2 (145) (156) (7) (8)
% Total Revenue 1.2% 1.2% - - 1.2% 1.4% - -
R&D expense (10,935) (9,762) 12 13 (3,073) (2,625) 17 15
% Total Revenue 23.9% 22.0% -2pp -2pp 25.6% 23.4% -2pp -2pp
SG&A expense (19,216) (18,419) 4 6 (5,371) (4,621) 16 16
% Total Revenue 41.9% 41.5% - - 44.7% 41.2% -3pp -3pp
Other operating income & expense 1,340 514 >2x >2x 107 189 (43) (42)
% Total Revenue 2.9% 1.2% +2pp +2pp 0.9% 1.7% -1pp -1pp
Operating profit 8,193 3,757 >2x >2x 1,234 1,094 13 14
Operating Margin 17.9% 8.5% +9pp +10pp 10.3% 9.8% +1pp +1pp
Net finance expense (1,282) (1,251) 2 1 (337) (315) 7 3
Joint ventures and associates (12) (5) >2x >2x - (1) (99) (99)
Profit before tax 6,899 2,501 >2x >2x 897 778 15 18
Taxation (938) 792 n/m n/m 62 124 (51) (67)
Tax rate 14% -32% -7% -16%
Profit after tax 5,961 3,293 81 96 959 902 6 4
Earnings per share $3.84 $2.12 81 96 $0.62 $0.58 7 5
Table 12: Reconciliation of Reported Profit before tax to EBITDA
FY 2023 FY 2022 % Change Q4 2023 Q4 2022 % Change
$m $m Actual CER $m $m Actual CER
Reported Profit before tax 6,899 2,501 >2x >2x 897 778 15 18
Net finance expense 1,282 1,251 2 1 337 315 7 3
Joint ventures and associates 12 5 >2x >2x - 1 (99) (99)
Depreciation, amortisation and impairment 5,387 5,480 (2) (1) 1,327 1,480 (10) (11)
EBITDA 13,580 9,237 47 55 2,561 2,574 (1) -
EBITDA for the comparative FY 2022 was negatively impacted by $3,484m unwind
of inventory fair value recognised on the acquisition of Alexion. EBITDA for
the comparative Q4 2022 was negatively impacted by $309m unwind of inventory
fair value uplift recognised on the acquisition of Alexion. This unwind had a
$114m negative impact on EBITDA in FY 2023 and a $36m negative impact on
EBITDA in Q4 2023.
Table 13: Reconciliation of Reported to Core financial measures: FY 2023
FY 2023 Reported Restructuring Intangible Asset Amortisation & Impairments Acquisition Other 11 (#_ftn11) Core Core
of Alexion
% Change
$m $m $m $m $m $m Actual CER
Gross profit 37,543 109 32 119 (3) 37,800 6 9
Product Sales Gross Margin 81.1% 81.7% +2pp +2pp
Distribution expense (539) - - - - (539) 1 2
R&D expense (10,935) 212 447 7 2 (10,267) 8 9
SG&A expense (19,216) 207 3,801 11 1,458 (13,739) 7 9
Total operating expense (30,690) 419 4,248 18 1,460 (24,545) 7 9
Other operating income & expense 1,340 (61) - - - 1,279 >2x >2x
Operating profit 8,193 467 4,280 137 1,457 14,534 9 14
Operating Margin 17.9% 31.7% +2pp +2pp
Net finance expense (1,282) - - - 298 (984) 1 (1)
Taxation (938) (107) (809) (32) (405) (2,291) 11 17
EPS $3.84 $0.23 $2.24 $0.07 $0.88 $7.26 9 15
Table 14: Reconciliation of Reported to Core financial measures: Q4 2023
Q4 2023 Reported Restructuring Intangible Asset Amortisation & Impairments Acquisition Other Core Core
of Alexion
% Change
$m $m $m $m $m $m Actual CER
Gross profit 9,716 (24) 8 37 1 9,738 11 11
Product Sales Gross Margin 79.6% 79.8% +3pp +2pp
Distribution expense (145) - - - - (145) (7) (9)
R&D expense (3,073) 95 61 2 1 (2,914) 15 14
SG&A expense (5,371) 44 938 4 351 (4,034) 13 12
Total operating expense (8,589) 139 999 6 352 (7,093) 13 12
Other operating income & expense 107 - - - - 107 (17) (15)
Operating profit 1,234 115 1,007 43 353 2,752 5 6
Operating Margin 10.3% 22.9% - -
Net finance expense (337) - - - 78 (259) 5 1
Taxation 62 (26) (192) (10) (76) (242) 7 4
EPS $0.62 $0.06 $0.53 $0.02 $0.22 $1.45 5 7
Profit and Loss drivers
Gross profit
‒ The calculation of Reported and Core Product Sales Gross Margin
excludes the impact of Alliance Revenue and Collaboration Revenue
‒ The change in Product Sales Gross Margin (Reported and Core) in FY
2023 was impacted by:
‒ Positive effects from product mix. The increased contribution from
Rare Disease and Oncology medicines had a positive impact on the Product Sales
Gross Margin. Sales of Vaxzevria and Evusheld, which were dilutive to Product
Sales Gross Margin in 2022, declined substantially in 2023
‒ Dilutive effects from product mix. The rising contribution of
Product Sales with profit sharing arrangements (Lynparza, Enhertu, Tezspire,
Koselugo) has a negative impact on Product Sales Gross Margin because
AstraZeneca records product revenues in certain markets and pays away a share
of the gross profits to its collaboration partners. The growth in Beyfortus
also has a dilutive impact on Product Sales Gross Margin, as AstraZeneca is
responsible for manufacturing and records its sales of goods to Sanofi as
Product Sales - these sales generate a much lower gross margin than the
Company average
‒ Dilutive effects from geographic mix. Emerging Markets, where
Product Sales Gross Margin tends to be below the Company average, grew as a
proportion of Total Revenue excluding COVID-19 medicines
‒ In FY 2022, the Reported Product Sales Gross Margin was impacted by
$3,484m from the unwind of the inventory fair value uplift recognised on the
acquisition of Alexion. In FY 2023, this effect had reduced to $114m
‒ Variations in Product Sales Gross Margin performance between periods
can continue to be expected due to product seasonality, foreign exchange
fluctuations, and other effects
R&D expense
‒ The change in R&D expense (Reported and Core) in the period was
impacted by:
‒ Recent positive data read-outs for several high priority medicines
that have ungated late-stage trials
‒ Investment in platforms, new technology and capabilities to enhance
R&D productivity
‒ Reported R&D expense was also impacted by intangible asset
impairments
SG&A expense
‒ The change in SG&A expense (Reported and Core) in the period was
driven primarily by 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
‒ Reported SG&A expense was also impacted by a $510m charge to
provisions relating to a legal settlement with Bristol-Myers Squibb and Ono
Pharmaceutical, and a $425m charge to provisions for product liability
litigations related to Nexium and Prilosec. The prior year was impacted by a
$775m legal settlement with Chugai Pharmaceutical Co. Ltd
Other operating income and expense
‒ Reported and Core Other operating income and expense in the year
included a $712m gain resulting from an update to the contractual
relationships for Beyfortus (nirsevimab), a $241m gain on the disposal of the
US rights to Pulmicort Flexhaler, and other disposal proceeds on the sale of
tangible assets, and royalties on certain medicines
Net finance expense
‒ Reported Net finance expense was impacted by the discount unwind on
acquisition-related liabilities. Core Net finance expense increased 2% (1% at
CER) with higher interest received on cash and short-term investments, higher
rates on floating debt and bond issuances, partially offset by higher rates on
floating debt and bond issuances
Taxation
‒ The effective Reported Tax rate for the twelve months to 31 December
2023 was 14% (FY 2022: -32%) and the effective Core Tax rate was 17% (FY 2022:
17%); both included a favourable adjustment of $828m to deferred taxes arising
from a UK group company undertaking a routine intragroup purchase of certain
intellectual property which was offset by updates to tax liabilities following
progress of reviews by tax authorities and administrative appeal processes and
changes to certain deferred tax balances
‒ The FY 2022 effective Reported Tax rate was lower as it included a
favourable adjustment of $883m relating to deferred taxes arising from an
internal reorganisation to integrate the Alexion business
‒ The cash tax paid for the twelve months to 31 December 2023 was
$2,366m (FY 2022: $1,623m), representing 34% of Reported Profit before tax (FY
2022: 65%)
‒ On 11 July 2023, Finance (No.2) Act 2023 was enacted in the UK,
introducing a global minimum effective tax rate of 15%. The legislation
implements a domestic top-up tax and a multinational top-up tax, effective for
accounting periods starting on or after 31 December 2023. AstraZeneca is
continuing to monitor potential impacts as further guidance is published by
the OECD and territories implement legislation to enact the rules. Management
has performed an assessment of the impact of the UK's Pillar 2 rules based on
our 2023 data and no Pillar 2 Income Taxes are expected to arise for most
jurisdictions in which the Group operates. It is anticipated that AstraZeneca
may, in some jurisdictions, incur additional tax liabilities, but the effect
on the Reported Tax rate is reasonably estimated to be immaterial
Dividends
‒ A second interim dividend of $1.97 per share (156.0 pence, 20.65
SEK) has been declared, resulting in a full-year dividend per share of $2.90
(227.8 pence, 30.29 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
‒ Provisional dates for the 2023 second interim dividend: ex-dividend
22 February 2024, record date 23 February 2024, payable on 25 March 2024.
Table 15: Cash Flow summary
FY 2023 FY 2022 Change
$m $m $m
Reported Operating profit 8,193 3,757 4,436
Depreciation, amortisation and impairment 5,387 5,480 (93)
Decrease in working capital and short-term provisions 300 3,757 (3,457)
Gains on disposal of intangible assets (251) (104) (147)
Fair value movements on contingent consideration arising from 549 82 467
business combinations
Non-cash and other movements (386) (692) 306
Interest paid (1,081) (849) (232)
Taxation paid (2,366) (1,623) (743)
Net cash inflow from operating activities 10,345 9,808 537
Net cash inflow before financing activities 6,281 6,848 (567)
Net cash outflow from financing activities (6,567) (6,823) 256
In FY 2022, the Reported Operating profit of $3,757m included a negative
impact of $3,484m relating to the unwind of the inventory fair value uplift
recognised on the acquisition of Alexion. This was offset by a corresponding
item (positive impact of $3,484m) in Decrease in working capital and
short-term provisions. Overall, the unwind of the fair value uplift had no
impact on Net cash inflow from operating activities. This unwind had $114m
negative impact on FY 2023 Reported Operating profit and offsetting positive
impact on working capital movements. As a result of the update to the
contractual relationships between AstraZeneca, Swedish Orphan Biovitrum AB
(Sobi) and Sanofi relating to the future sales of Beyfortus (nirsevimab) in
the US, a gain of $712m has been recorded in Non-cash and other movements,
with no overall net impact on the Net cash inflow from operating activities.
Included within Net cash inflow before financing activities is a Movement in
the profit-participation liability of $190m, including a cash receipt from
Sobi in Q1 2023 after achievement of a regulatory milestone. The associated
cash flow is presented within investing activities.
The decrease in Net cash outflow from financing activities of $256m is
primarily driven by the increase in Issue of loans and borrowings of $3,816m,
offset by the increase in Repayment of loans and borrowings of $3,671m.
Capital expenditure
Capital expenditure amounted to $1,361m in the twelve months to 31 December
2023 (FY 2022: $1,091m).
Capital expenditure is expected to increase substantially in 2024, driven by
investment in several major manufacturing projects and continued investment in
technology upgrades.
Table 16: Net debt summary
At 31 At 31
Dec 2023 Dec 2022
$m $m
Cash and cash equivalents 5,840 6,166
Other investments 122 239
Cash and investments 5,962 6,405
Overdrafts and short-term borrowings (515) (350)
Lease liabilities (1,128) (953)
Current instalments of loans (4,614) (4,964)
Non-current instalments of loans (22,365) (22,965)
Interest-bearing loans and borrowings (Gross debt) (28,622) (29,232)
Net derivatives 150 (96)
Net debt (22,510) (22,923)
Net debt decreased by $413m in the twelve months to 31 December 2023 to
$22,510m. 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 and further details on Net debt 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, 4.875% Notes due 2028, 1.750% Notes due 2028,
4.900% Notes due 2030, 2.250% Notes due 2031 and 4.875% Notes due 2033 (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 issued by
AstraZeneca PLC is full and unconditional and joint and several.
The AstraZeneca Finance Notes are senior unsecured obligations of AstraZeneca
Finance and rank equally with all of AstraZeneca Finance's existing and future
senior unsecured and unsubordinated indebtedness. The guarantee by AstraZeneca
PLC of the AstraZeneca Finance Notes is the senior unsecured obligation of
AstraZeneca PLC and ranks equally with all of AstraZeneca PLC's existing and
future senior unsecured and unsubordinated indebtedness. Each guarantee by
AstraZeneca PLC is effectively subordinated to any secured indebtedness of
AstraZeneca PLC to the extent of the value of the assets securing such
indebtedness. The AstraZeneca Finance Notes are structurally subordinated to
indebtedness and other liabilities of the subsidiaries of AstraZeneca PLC,
none of which guarantee the AstraZeneca Finance Notes.
AstraZeneca PLC manages substantially all of its operations through divisions,
branches and/or investments in subsidiaries and affiliates. Accordingly, the
ability of AstraZeneca PLC to service its debt and guarantee obligations is
also dependent upon the earnings of its subsidiaries, affiliates, branches and
divisions, whether by dividends, distributions, loans or otherwise.
Please refer to the Consolidated financial statements of AstraZeneca PLC in
our Annual Report on Form 20‑F and reports on Form 6-K with our quarterly
financial results as filed or furnished with the SEC for further financial
information regarding AstraZeneca PLC and its consolidated subsidiaries. For
further details, terms and conditions of the AstraZeneca Finance Notes please
refer to AstraZeneca PLC's reports on Form 6-K furnished to the SEC on 3 March
2023 and 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 17: Obligor group summarised Statement of comprehensive income
FY 2023 FY 2022
$m $m
Total Revenue - -
Gross profit - -
Operating loss (34) (27)
Loss for the period (976) (687)
Transactions with subsidiaries that are not issuers or guarantors 15,660 1,071
Table 18: Obligor group summarised Statement of financial position
At 31 Dec 2023 At 31 Dec 2022
$m $m
Current assets 5 4
Non-current assets - -
Current liabilities (4,856) (2,839)
Non-current liabilities (22,239) (22,797)
Amounts due from subsidiaries that are not issuers or guarantors 18,421 7,806
Amounts due to subsidiaries that are not issuers or guarantors - (293)
Foreign exchange
The Company's transactional currency exposures on working capital balances,
which typically extend for up to three months, are hedged where practicable
using forward foreign exchange contracts against the individual companies'
reporting currency. Foreign exchange gains and losses on forward contracts
transacted for transactional hedging are taken to profit or to Other
comprehensive income if the contract is in a designated cashflow hedge. In
addition, the Company's external dividend payments, paid principally in pound
sterling and Swedish krona, are fully hedged from announcement to payment
date.
Table 19: Currency sensitivities
The Company provides the following currency-sensitivity information:
Average Annual impact ($m) of 5% strengthening (FY 2024 average rate vs. FY 2023
average) (( 12 (#_ftn12) ))
rates vs. USD
Currency Primary Relevance FY YTD ( ) Change Total Revenue Core Operating Profit
2023 13 (#_ftn13)
2024 14 (#_ftn14)
(%)
EUR Total Revenue 0.92 0.92 1 397 179
CNY Total Revenue 7.09 7.18 (1) 322 182
JPY Total Revenue 140.60 145.97 (4) 177 119
Other(( 15 (#_ftn15) )) 453 227
GBP Operating expense 0.80 0.79 2 60 (126)
SEK Operating expense 10.61 10.34 3 9 (63)
Sustainability
Since the last quarterly report, AstraZeneca:
Access to healthcare
- Continued to make a high-level contribution to the Partnership for
Health System Sustainability and Resilience (PHSSR), providing a valuable
platform for dialogue with policymakers and other health system stakeholders:
‒ The PHSSR EU expert advisory group launched its inaugural
non-communicable disease (NCD) policy report, 'A stitch in time', on early
intervention to tackle Europe's NCD crisis at an event in the European
Parliament with more than 100 stakeholders from government, academia,
advocacy, policy and industry groups
‒ National initiatives and policy improvements to strengthen health
systems continued in countries including Brazil, Canada, Saudi Arabia, Greece,
the Netherlands, Italy and Japan
‒ Through Healthy Heart Africa (HHA), trained more than 11,390
healthcare workers, conducted 47.95 million blood pressure screenings
cumulatively since launching in 2014 and identified 9.64 million people with
elevated blood pressure as of the end of December 2023. HHA has conducted one
million screenings per month since February 2023. The programme is on track to
achieve its ambition to reach 10 million people with elevated blood pressure
by 2025
‒ Through the Young Health Programme (YHP), continued to be recognised
for achievements in reaching millions of young people with information on NCD
risk behaviours. YHP directly reached six million young people in 2023, an
increase of 110% from 2022, and trained 385,000 people across 40 countries.
More than 4,400 AstraZeneca employees volunteered time to YHP community
projects in 2023
Environmental protection
‒ Joined global health and climate leaders at COP28, as part of the
first official Health Day at the UN Climate Change Conference, to highlight
the urgency of the climate-health crisis and share scalable solutions to
decarbonise and adapt health systems. The Company convened cross-sector
stakeholders for a Reuters panel discussion on tackling the impact of the
climate crisis on lung health, and CEO Pascal Soriot hosted a session through
the Sustainable Markets Initiative (SMI) Health Systems Task Force on
accelerating the transition to net zero health systems
‒ Through the SMI Health Systems Task Force, announced an
industry-first renewable power agreement in China together with four global
healthcare leaders and renewable energy company Envision Energy, resulting in
potential annual emissions savings of approximately 120,000 tonnes, the
equivalent of taking 25,000 cars off the road
‒ Through AZ Forest, AstraZeneca's global reforestation and
biodiversity initiative, planted 20 million trees together with partners, as
part of the Company's $400 million commitment to plant and maintain 200
million trees by 2030. In December, the Company pledged to plant up to six
million trees in western Kenya as part of AZ Forest, building on African
reforestation initiatives in Ghana and Rwanda
Ethics and transparency
‒ Marked Global Ethics Day in October 2023, following the launch of
Code of Ethics training focused on living the AZ Values and the role of ethics
in everyday activities and decisions. The Company also launched its 2023
Ethics Survey alongside the training, to provide valuable insights into
employee perspectives on AstraZeneca's ethical culture
‒ Appeared on the Forbes list of World's Best Employers for the fourth
consecutive year and the World's Top Companies for Women, for the third
consecutive year, as well as the FT Diversity Leaders 2024 for the fifth
consecutive year, demonstrating the progress being made on the Company's
People strategy and AstraZeneca's position as a Great Place to Work
Research and development
This section covers R&D events and milestones that have occurred since the
prior results announcement on 9 November 2023, up to and including events on
7 February 2024.
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 four major medical congresses since the prior results
announcement: the San Antonio Breast Cancer Congress (SABCS) in December 2023,
the 65th American Society of Haematology Annual Meeting and Exposition (ASH)
in December 2023, the American Society of Clinical Oncology Gastrointestinal
Cancers Symposium (ASCO GI) in January 2024 and the American Society of
Clinical Oncology Genitourinary Cancers (ASCO GU) in January 2024.
Imfinzi and Imjudo
Event Commentary
Approval China For the 1st-line treatment of adult patients with locally advanced or
metastatic BTC in combination with chemotherapy (gemcitabine and cisplatin).
(TOPAZ-1, November 2023)
Trial update PACIFIC-2 PACIFIC-2 Phase III trial for Imfinzi concurrently administered with
chemoradiotherapy did not achieve statistical significance for the primary
endpoint of PFS versus chemoradiotherapy alone for the treatment of patients
with unresectable, Stage III NSCLC. (November 2023)
Presentation: ASCO GI EMERALD-1 Imfinzi plus TACE and bevacizumab reduced the risk of disease progression or
death by 23% compared to TACE alone (HR 0.77; 95% CI 0.61-0.98; p=0.032) with
median PFS of 15 months in patients treated with the Imfinzi combination
versus 8.2 months with TACE. (January 2024)
Enhertu
Event Commentary
Priority Review US For the treatment of adult patients with unresectable or metastatic
HER2-positive (immunohistochemistry IHC 3+) solid tumours who have received
prior treatment or who have no satisfactory alternative treatment options.
(DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02, January 2024)
Truqap
Event Commentary
Approval US In combination with Faslodex for the treatment of adult patients with
HR-positive, HER2-negative locally advanced or metastatic breast cancer with
one or more biomarker alterations (PIK3CA, AKT1 or PTEN) that have progressed
on at least one endocrine-based regimen in the metastatic setting or
experienced recurrence on or within 12 months of completing adjuvant therapy.
(CAPItello-291, November 2023)
BioPharmaceuticals - CVRM
Lokelma
Event Commentary
Termination STABILIZE-CKD and DIALIZE-Outcomes Phase III evidence trials discontinued.
Decision was made due to substantially increased enrolment timelines and low
event rates, respectively, which made it prohibitive to deliver study results
within a timeframe to meaningfully advance clinical practice. (December 2023)
Wainua
Event Commentary
Approval US Treatment of the polyneuropathy of hereditary transthyretin-mediated
amyloidosis in adults, commonly referred to as ATTRv-PN. (NEURO-TTRansform,
December 2023)
Rare Disease
Alexion, AstraZeneca Rare Disease presented new real-world and clinical data
at the 65th American Society of Haematology (ASH) , across PNH, AL
amyloidosis, aHUS and haematopoietic stem cell transplant-associated
thrombotic microangiopathy (HSCT-TMA).
Voydeya
Event Commentary
Approval JP Treatment of patients with PNH with clinically significant EVH while treated
with Ultomiris or Soliris. (ALPHA, January 2024)
Presentation: ASH LTE ALPHA Phase III trial New results from the 24-week and long-term extension period from the pivotal
ALPHA Phase III trial reinforce the potential for Voydeya add-on therapy to
address clinically significant EVH in the small subset of PNH patients who
experience this condition while treated with C5 inhibitor therapy, allowing
them to maintain control of intravascular haemolysis through standard-of-care
treatment with Ultomiris or Soliris. (December 2023)
acoramidis
Event Commentary
Phase III data readout ATTRibute-CM (BridgeBio) Positive high-level results from the Japan Phase III trial of acoramidis in
adults with ATTR-CM showed consistency to those in the global BridgeBio
Pharma, Inc. (BridgeBio) ATTRibute-CM Phase III trial, including survival,
cardiac-related hospitalisations and other measures of improved functions at
30 months. (February 2024)
Condensed consolidated financial statements
Table 20: Condensed consolidated statement of comprehensive income: FY 2023
For the twelve months ended 31 December 2023 2022
$m $m
Total Revenue 16 (#_ftn16) 45,811 44,351
Product Sales 43,789 42,998
Alliance Revenue 1,428 755
Collaboration Revenue 594 598
Cost of sales (8,268) (12,391)
Gross profit 37,543 31,960
Distribution expense (539) (536)
Research and development expense (10,935) (9,762)
Selling, general and administrative expense (19,216) (18,419)
Other operating income and expense 1,340 514
Operating profit 8,193 3,757
Finance income 344 95
Finance expense (1,626) (1,346)
Share of after tax losses in associates and joint ventures (12) (5)
Profit before tax 6,899 2,501
Taxation (938) 792
Profit for the period 5,961 3,293
Other comprehensive income:
Items that will not be reclassified to profit or loss:
Remeasurement of the defined benefit pension liability (406) 1,118
Net gains/(losses) on equity investments measured at fair value through other 278 (88)
comprehensive income
Fair value movements related to own credit risk on bonds designated as fair (6) 2
value through profit or loss
Tax on items that will not be reclassified to profit or loss 101 (216)
(33) 816
Items that may be reclassified subsequently to profit or loss:
Foreign exchange arising on consolidation 608 (1,446)
Foreign exchange arising on designated liabilities in net investment hedges 24 (282)
Fair value movements on cash flow hedges 266 (97)
Fair value movements on cash flow hedges transferred to profit and loss (145) 73
Fair value movements on derivatives designated in net investment hedges 44 (8)
Costs of hedging (19) (7)
Tax on items that may be reclassified subsequently to profit or loss (12) 73
766 (1,694)
Other comprehensive income/(expense), net of tax 733 (878)
Total comprehensive income for the period 6,694 2,415
Profit attributable to:
Owners of the Parent 5,955 3,288
Non-controlling interests 6 5
5,961 3,293
Total comprehensive income attributable to:
Owners of the Parent 6,688 2,413
Non-controlling interests 6 2
6,694 2,415
Basic earnings per $0.25 Ordinary Share $3.84 $2.12
Diluted earnings per $0.25 Ordinary Share $3.81 $2.11
Weighted average number of Ordinary Shares in issue (millions) 1,549 1,548
Diluted weighted average number of Ordinary Shares in issue (millions) 1,562 1,560
Table 21: Condensed consolidated statement of comprehensive income: Q4 2023
For the quarter ended 31 December 2023 2022
$m $m
Total Revenue(16) 12,024 11,207
Product Sales 11,323 10,798
Alliance Revenue 424 251
Collaboration Revenue 277 158
Cost of sales (2,308) (2,900)
Gross profit 9,716 8,307
Distribution expense (145) (156)
Research and development expense (3,073) (2,625)
Selling, general and administrative expense (5,371) (4,621)
Other operating income and expense 107 189
Operating profit 1,234 1,094
Finance income 108 45
Finance expense (445) (360)
Share of after tax losses in associates and joint ventures - (1)
Profit before tax 897 778
Taxation 62 124
Profit for the period 959 902
Other comprehensive income:
Items that will not be reclassified to profit or loss:
Remeasurement of the defined benefit pension liability (405) (165)
Net gains/(losses) on equity investments measured at fair value through other 233 (67)
comprehensive income
Fair value movements related to own credit risk on bonds designated as fair (11) 1
value through profit or loss
Tax on items that will not be reclassified to profit or loss 101 75
(82) (156)
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation 809 1,047
Foreign exchange arising on designated liabilities in net investment hedges 87 39
Fair value movements on cash flow hedges 204 117
Fair value movements on cash flow hedges transferred to profit and loss (173) (177)
Fair value movements on derivatives designated in net investment hedges (3) (41)
Costs of hedging (16) 4
Tax on items that may be reclassified subsequently to profit or loss (5) (22)
903 967
Other comprehensive income, net of tax 821 811
Total comprehensive income for the period 1,780 1,713
Profit attributable to:
Owners of the Parent 960 901
Non-controlling interests (1) 1
959 902
Total comprehensive income attributable to:
Owners of the Parent 1,781 1,712
Non-controlling interests (1) 1
1,780 1,713
Basic earnings per $0.25 Ordinary Share $0.62 $0.58
Diluted earnings per $0.25 Ordinary Share $0.62 $0.58
Weighted average number of Ordinary Shares in issue (millions) 1,549 1,549
Diluted weighted average number of Ordinary Shares in issue (millions) 1,561 1,559
Table 22: Condensed consolidated statement of financial position
At 31 Dec At 31 Dec
2023 2022
$m $m
Assets
Non-current assets
Property, plant and equipment 9,402 8,507
Right-of-use assets 1,100 942
Goodwill 20,048 19,820
Intangible assets 38,089 39,307
Investments in associates and joint ventures 147 76
Other investments 1,530 1,066
Derivative financial instruments 228 74
Other receivables 803 835
Deferred tax assets 4,718 3,263
76,065 73,890
Current assets
Inventories 5,424 4,699
Trade and other receivables 12,126 10,521
Other investments 122 239
Derivative financial instruments 116 87
Income tax receivable 1,426 731
Cash and cash equivalents 5,840 6,166
Assets held for sale - 150
25,054 22,593
Total assets 101,119 96,483
Liabilities
Current liabilities
Interest-bearing loans and borrowings (5,129) (5,314)
Lease liabilities (271) (228)
Trade and other payables (22,374) (19,040)
Derivative financial instruments (156) (93)
Provisions (1,028) (722)
Income tax payable (1,584) (896)
(30,542) (26,293)
Non-current liabilities
Interest-bearing loans and borrowings (22,365) (22,965)
Lease liabilities (857) (725)
Derivative financial instruments (38) (164)
Deferred tax liabilities (2,844) (2,944)
Retirement benefit obligations (1,520) (1,168)
Provisions (1,127) (896)
Other payables (2,660) (4,270)
(31,411) (33,132)
Total liabilities (61,953) (59,425)
Net assets 39,166 37,058
Equity
Capital and reserves attributable to equity holders of the Parent
Share capital 388 387
Share premium account 35,188 35,155
Other reserves 2,065 2,069
Retained earnings 1,502 (574)
39,143 37,037
Non-controlling interests 23 21
Total equity 39,166 37,058
Table 23: 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 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 expense - - - (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
At 1 Jan 2023 387 35,155 2,069 (574) 37,037 21 37,058
Profit for the period - - - 5,955 5,955 6 5,961
Other comprehensive income - - - 733 733 - 733
Transfer to other reserves - - (4) 4 - - -
Transactions with owners
Dividends - - - (4,487) (4,487) - (4,487)
Dividends paid to non-controlling interests - - - - - (4) (4)
Issue of Ordinary Shares 1 33 - - 34 - 34
Share-based payments charge for the period - - - 579 579 - 579
Settlement of share plan awards - - - (708) (708) - (708)
Net movement 1 33 (4) 2,076 2,106 2 2,108
At 31 Dec 2023 388 35,188 2,065 1,502 39,143 23 39,166
Table 24: Condensed consolidated statement of cash flows
For the twelve months ended 31 December 2023 2022
$m $m
Cash flows from operating activities
Profit before tax 6,899 2,501
Finance income and expense 1,282 1,251
Share of after tax losses of associates and joint ventures 12 5
Depreciation, amortisation and impairment 5,387 5,480
Decrease in working capital and short-term provisions 300 3,757
Gains on disposal of intangible assets (251) (104)
Fair value movements on contingent consideration arising from business 549 82
combinations
Non-cash and other movements (386) (692)
Cash generated from operations 13,792 12,280
Interest paid (1,081) (849)
Tax paid (2,366) (1,623)
Net cash inflow from operating activities 10,345 9,808
Cash flows from investing activities
Acquisition of subsidiaries, net of cash acquired (189) (48)
Payments upon vesting of employee share awards attributable to business (84) (215)
combinations
Payment of contingent consideration from business combinations (826) (772)
Purchase of property, plant and equipment (1,361) (1,091)
Disposal of property, plant and equipment 132 282
Purchase of intangible assets (2,417) (1,480)
Disposal of intangible assets 291 447
Movement in profit-participation liability 190 -
Purchase of non-current asset investments (136) (45)
Disposal of non-current asset investments 32 42
Movement in short-term investments, fixed deposits and other investing 97 (114)
instruments
Payments to associates and joint ventures (80) (26)
Interest received 287 60
Net cash outflow from investing activities (4,064) (2,960)
Net cash inflow before financing activities 6,281 6,848
Cash flows from financing activities
Proceeds from issue of share capital 33 29
Issue of loans and borrowings 3,816 -
Repayment of loans and borrowings (4,942) (1,271)
Dividends paid (4,481) (4,364)
Hedge contracts relating to dividend payments (19) (127)
Repayment of obligations under leases (268) (244)
Movement in short-term borrowings 161 74
Payment of Acerta Pharma share purchase liability (867) (920)
Net cash outflow from financing activities (6,567) (6,823)
Net (decrease)/increase in Cash and cash equivalents in the period (286) 25
Cash and cash equivalents at the beginning of the period 5,983 6,038
Exchange rate effects (60) (80)
Cash and cash equivalents at the end of the period 5,637 5,983
Cash and cash equivalents consist of:
Cash and cash equivalents 5,840 6,166
Overdrafts (203) (183)
5,637 5,983
Notes to the Condensed consolidated financial statements
Note 1: Basis of preparation and accounting policies
These Condensed consolidated financial statements for the twelve months ended
31 December 2023 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 IFRS
Accounting Standards as issued by the International Accounting Standards Board
(IASB) and International Accounting Standards as adopted by the European
Union.
These Condensed consolidated financial statements comprise the financial
results of AstraZeneca PLC for the years to 31 December 2023 and 2022 together
with the Statement of financial position as at 31 December 2023 and 2022. The
results for the year to 31 December 2023 have been extracted from the 31
December 2023 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 20 February 2024
within the Annual Report and Form 20-F Information 2023.
The financial information set out above does not constitute the Group's
statutory accounts for the years to 31 December 2023 or 2022 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 2023 or 31 December 2022. Statutory accounts for the year to 31
December 2023 were approved by the Board of Directors for release on 8
February 2024.
Except as noted below, amendments to accounting standards issued by the IASB
and adopted in the year ended 31 December 2023 did not have a material impact
on the result or financial position of the Group and 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 2022.
The comparative figures for the financial year ended 31 December 2022 are not
the Group's statutory accounts for that financial year. Those accounts have
been reported on by the Group's auditors and have been delivered to the
Registrar of Companies; their report was (i) 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.
Alliance and Collaboration Revenues
Effective 1 January 2023, the Group has updated the presentation of Total
Revenue on the face of the Statement of Comprehensive Income to include
Alliance Revenue as a separate element to Collaboration Revenue. Alliance
Revenue, previously reported within Collaboration Revenue, comprises income
related to sales made by collaboration partners, where AstraZeneca is entitled
to a share of gross profits, share of revenues or royalties, which are
recurring in nature while the collaboration arrangement remains in place.
Alliance Revenue does not include Product Sales where AstraZeneca is leading
commercialisation in a territory.
Collaboration Revenue arising from collaborative arrangements where the Group
retains a significant ongoing economic interest and receives upfront amounts
and event- triggered milestones, which arise from the licensing of
intellectual property, will continue to be reported as Collaboration Revenue.
In collaboration arrangements either AstraZeneca or the collaborator acts as
principal in sales to the end customer. Where AstraZeneca acts as principal,
we record 100% of sales to the end customer within Product Sales. The updated
presentation reflects the increasing importance of income arising from share
of gross profits arrangements where collaboration partners are responsible for
booking revenues in some or all territories.
The comparative revenue reported in FY 2022 relating to the twelve months to
31 December 2022 has been retrospectively adjusted to reflect the new split of
Total Revenue, resulting in Alliance Revenue of $755m being reported for the
twelve months to 31 December 2022, however the combined total of Alliance
Revenue and Collaboration Revenue is equal to the previously reported
Collaboration Revenue total for the twelve months to 31 December 2022.
Going concern
The Group has considerable financial resources available. As at 31 December
2023, the Group had $12.7bn in financial resources (Cash and cash equivalent
balances of $5.8bn and undrawn committed bank facilities of $6.9bn, of which
$2.0bn were available until February 2025 and the remaining $4.9bn were
available until April 2026 - the maturity of this facility was extended in
February 2024 to April 2029 - with only $5.4bn of borrowings due within one
year). These facilities contain no financial covenants and were undrawn at 31
December 2023.
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 202
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2022/pdf/AstraZeneca_AR_2022.pdf)
2.
IAS 12 'Income Taxes'
On 23 May 2023, the IASB issued an amendment to IAS 12 'Income Taxes' to
clarify how the effects of the global minimum tax framework should be
accounted for and disclosed effective 1 January 2023. This was endorsed by the
UK Endorsement Board on 19 July 2023 and has been adopted by the Group for
2023 reporting. The Group has applied the exemption to recognising and
disclosing information about deferred tax assets and liabilities related to
Pillar 2 income taxes.
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 impairment charges of $434m have been
recorded against intangible assets during the twelve months ended 31 December
2023 (FY 2022: $224m net charge). Impairment charges in respect of medicines
in development were $417m (FY 2022: $95m net charge) including the $244m
impairment of the ALXN1840 intangible asset, following the decision to
discontinue this development programme in Wilson's disease. Impairment charges
in respect of launched medicines were $17m (FY 2022: $146m).
As previously disclosed, on 16 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 (TCR-Ts). The purchase price
allocation exercise has completed, with the fair value of total consideration
determined at $267m. Intangible assets of $100m and goodwill of $158m were
recognised in the acquisition balance sheet, as well as a cash outflow of
$189m net of cash acquired. Future contingent milestones-based and
non-contingent consideration is payable to a maximum of $120m. Neogene's
results have been consolidated into the Group's results from 16 January 2023.
The acquisition of CinCor Pharma, Inc. (CinCor) completed on 24 February 2023,
recorded as an asset acquisition, with consideration and net assets acquired
of $1,268m, which included intangible assets acquired of $780m, $424m of cash
and cash equivalents, and $75m of marketable securities. The Condensed
consolidated statement of cash flows includes a $1,204m payment for the
intangible assets, which is presented net of the $424m cash and cash
equivalents acquired within Purchase of intangible assets, whilst the $75m
increase in marketable securities is presented within Movement in short-term
investments, fixed deposits and other investing instruments. Contingent
consideration of up to $496m could be paid on achievement of regulatory
milestones, and will be recognised when the associated milestones are
triggered.
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 202
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2022/pdf/AstraZeneca_AR_2022.pdf)
2. Net debt is a non-GAAP financial measure.
Table 25: Net debt
At 1 Jan 2023 Cash flow Acquisitions Non-cash Exchange movements At 31 Dec 2023
& other
$m $m $m $m $m $m
Non-current instalments of loans (22,965) (3,826) - 4,617 (191) (22,365)
Non-current instalments of leases (725) - (6) (118) (8) (857)
Total long-term debt (23,690) (3,826) (6) 4,499 (199) (23,222)
Current instalments of loans (4,964) 4,942 - (4,588) (4) (4,614)
Current instalments of leases (228) 298 (5) (337) 1 (271)
Bank collateral received (89) (126) - - - (215)
Other short-term borrowings excluding overdrafts (78) (35) - - 16 (97)
Overdrafts (183) (20) - 1 (1) (203)
Total current debt (5,542) 5,059 (5) (4,924) 12 (5,400)
Gross borrowings (29,232) 1,233 (11) (425) (187) (28,622)
Net derivative financial instruments (96) 19 - 227 - 150
Net borrowings (29,328) 1,252 (11) (198) (187) (28,472)
Cash and cash equivalents 6,166 (267) - - (59) 5,840
Other investments - current 239 (95) - 1 (23) 122
Cash and investments 6,405 (362) - 1 (82) 5,962
Net debt (22,923) 890 (11) (197) (269) (22,510)
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 2023 was $215m (31 December 2022: $89m) and the
carrying value of such cash collateral posted by the Group at 31 December 2023
was $102m (31 December 2022: $162m).
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 $833m (31 December 2022: $1,646m), which is
shown in current other payables.
Net debt decreased by $413m in the twelve months to 31 December 2023 to
$22,510m. Details of the committed undrawn bank facilities are disclosed
within the going concern section of Note 1.
During the twelve months ended 31 December 2023, Moody's upgraded the
Company's solicited long term credit rating from A3 to A2 and its short term
rating from P-2 to P-1. Standard and Poor's credit ratings were unchanged
(long term: A; short term: A-1).
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 $313m at 31 December 2023 (31
December 2022: $186m) and for which fair value gains of $17m have been
recognised in the twelve months ended 31 December 2023 (FY 2022: $50m). 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 gains/(losses) on equity investments measured at fair value
through other comprehensive income in the Condensed consolidated statement of
comprehensive income for the twelve months ended 31 December 2023 are Level 1
fair value measurements, valued based on quoted prices in active markets.
Financial instruments measured at fair value include $1,550m of other
investments, $4,425m held in money-market funds and $150m of derivatives as at
31 December 2023. With the exception of derivatives being Level 2 fair valued,
certain equity investments of $325m categorised as Level 3, the aforementioned
balances are Level 1 fair valued. Financial instruments measured at amortised
cost include $215m of cash collateral pledged to counterparties. The total
fair value of interest-bearing loans and borrowings at 31 December 2023, which
have a carrying value of $28,622m in the Condensed consolidated statement of
financial position, was $27,987m.
As announced in April 2023, the contractual relationship between AstraZeneca
and Sobi relating to future sales of Beyfortus (nirsevimab) in the US has been
replaced by a royalty relationship between Sanofi and Sobi. As a result, a
non-current other payable representing AstraZeneca's future obligations to
Sobi was eliminated from AstraZeneca's Statement of Financial Position in the
quarter to 30 June 2023, and AstraZeneca recorded a gain of $712m in Core
Other operating income.
Table 26: Financial instruments - contingent consideration
2023 2022
Diabetes alliance Other Total Total
$m $m $m $m
At 1 January 2,124 98 2,222 2,865
Additions through business combinations - 60 60 -
Settlements (823) (3) (826) (772)
Disposals - - - (121)
Revaluations 520 29 549 82
Discount unwind 124 8 132 168
At 31 December 1,945 192 2,137 2,222
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 $1,945m (31 December 2022: $2,124m) would
increase/decrease by $195m with an increase/decrease in sales of 10%, as
compared with the current estimates.
Note 5: Pensions and other post-retirement benefit obligations
During the twelve months ended 31 December 2023, AstraZeneca Pharmaceuticals
LP terminated its main defined benefit pension plan. A total of $839m of
pension obligations were discharged, $142m of which was settled via a cash
payment to the participants and the remaining $697m was transferred to an
external insurer via a buy-out. At 31 December 2023, all assets and
obligations had been discharged.
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 2022 and the Interim Financial Statements for H1
2023 and Q3 2023 (the Disclosures).
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, AstraZeneca considers each of the claims
to represent a contingent liability or a contingent asset where the matter is
brought by AstraZeneca, and discloses information with respect to the nature
and facts of the cases in accordance with IAS 37.
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 2023 and to 8 February
2024
Patent litigation
Legal proceedings brought against AstraZeneca considered to be contingent liabilities
Enhertu
US patent proceedings
In October 2020, Seagen Inc. (Seagen) filed a complaint against Daiichi Sankyo
Company, Limited (Daiichi Sankyo) in the US District Court for the Eastern
District of Texas (District Court) alleging that Enhertu infringes a Seagen
patent. AstraZeneca co-commercialises Enhertu with Daiichi Sankyo, Inc. in the
US. After trial in April 2022, the jury found that the patent was infringed
and awarded Seagen $41.82m in past damages. In July 2022, the District Court
entered final judgment and declined to enhance damages on the basis of
wilfulness. In October 2023, the District Court entered an amended final
judgment that requires Daiichi Sankyo to pay Seagen a royalty of 8% on US
sales of Enhertu from April 1, 2022, through November 4, 2024, in addition to
the past damages previously awarded by the Court. AstraZeneca and Daiichi
Sankyo have appealed the District Court's decision.
In December 2020 and January 2021, AstraZeneca and Daiichi Sankyo, Inc. filed
post-grant review (PGR) petitions with the US Patent and Trademark Office
(USPTO) alleging, inter alia, that the Seagen patent is invalid for lack of
written description and enablement. The USPTO initially declined to institute
the PGRs, but, in April 2022, the USPTO granted the rehearing requests,
instituting both PGR petitions. Seagen subsequently disclaimed all patent
claims at issue in one of the PGR proceedings. In July 2022, the USPTO
reversed its institution decision and declined to institute the other PGR
petition. AstraZeneca and Daiichi Sankyo, Inc. requested reconsideration of
the decision not to institute review of the patent. In February 2023, the
USPTO reinstituted the PGR proceeding. An oral hearing took place in August
2023. In January 2024, the USPTO issued a decision that Seagen's patent is
unpatentable, invalidating all claims asserted against Enhertu. The USPTO's
decision does not overturn the Texas District Court's decision unless and
until the USPTO's decision is affirmed on appeal by the US Court of Appeals
for the Federal Circuit. No such appeal has been filed.
Legal proceedings brought by AstraZeneca considered to be contingent assets
Farxiga
US patent proceedings
In May 2021, AstraZeneca proceeded to trial against ANDA filer Zydus
Pharmaceuticals (USA) Inc. (Zydus) in the US District Court for the District
of Delaware (District Court). 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 decision. Zydus's appeal has been dismissed.
In December 2023, AstraZeneca initiated ANDA litigation against Sun
Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries, Inc. in the
District Court. No trial date has been set.
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. In February 2023, in response to the Paragraph IV notice,
AstraZeneca, MSD International Business GmbH, and the University of Sheffield
initiated ANDA litigation against Natco Pharma Limited (Natco) in the US
District Court for the District of New Jersey. In the complaint, AstraZeneca
alleged that Natco's generic version of Lynparza, if approved and marketed,
would infringe patents listed in the FDA Orange Book with reference to
Lynparza. No trial date has been scheduled.
In December 2023, AstraZeneca received a Paragraph IV notice letter from ANDA
filer relating to patents listed in the FDA Orange Book with reference to
Lynparza. In February 2024, in response to the Paragraph IV notice,
AstraZeneca, MSD International Business GmbH, and the University of Sheffield
initiated ANDA litigation against Sandoz Inc. (Sandoz) in the US District
Court for the District of New Jersey. In the complaint, AstraZeneca alleged
that Sandoz's generic version of Lynparza, if approved and marketed, would
infringe patents listed in the FDA Orange Book with reference to Lynparza. No
trial date has been scheduled.
Soliris
US patent proceedings
In January 2024, Alexion initiated patent infringement litigation against
Samsung Bioepis Co. Ltd. in the US District Court for the District of Delaware
alleging that Samsung's biosimilar eculizumab product, for which Samsung is
currently seeking FDA approval, will infringe six Soliris-related patents. No
trial date has been scheduled. Five of the six asserted patents are also the
subject of inter partes review proceedings before the US Patent and Trademark
Office.
Tagrisso
Patent proceedings outside the US
In Russia, in August 2023, AstraZeneca filed lawsuits in the Arbitration Court
of the Moscow Region (Court) against the Ministry of Health of the Russian
Federation and Axelpharm LLC related to Axelpharm's improper use of
AstraZeneca's information to obtain authorisation to market a generic version
of Tagrisso. In December 2023, the Court dismissed the lawsuit against the
Ministry of Health of the Russian Federation. In January 2024, AstraZeneca
filed an appeal, which is pending. The lawsuit against Axelpharm remains
pending before the Court.
In Russia, in November 2023, Axelpharm LLC filed a compulsory licensing action
against AstraZeneca in the Arbitration Court of the Moscow Region (Court)
related to a patent that covers Tagrisso. The lawsuit remains pending before
the Court.
Product liability litigation
Legal proceedings brought against AstraZeneca for which a provision has been taken
Nexium and Losec/Prilosec
US proceedings
AstraZeneca has been defending lawsuits brought in federal and state courts
involving claims that plaintiffs have been diagnosed with various injuries
following treatment with proton pump inhibitors (PPIs), including Nexium and
Prilosec. Most of the lawsuits alleged kidney injury. 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. In addition to the MDL cases, there were cases alleging
kidney injury filed in Delaware and New Jersey state courts.
In addition, AstraZeneca has been defending lawsuits involving allegations of
gastric cancer following treatment with PPIs, including one such claim in the
US District Court for the Middle District of Louisiana (Louisiana District
Court).
In October 2023, AstraZeneca resolved all pending claims in the MDL, as well
as all pending claims in Delaware and New Jersey state courts, for $425M, for
which a provision has been taken. The
only remaining case is the one pending in the Louisiana District Court. The
Court in that case has postponed trial, which was previously scheduled to
begin in April 2024 No new trial date has been set.
Commercial litigation
Legal proceedings brought against AstraZeneca considered to be contingent
liabilities
340B Antitrust Litigation
US proceedings
In September 2021, AstraZeneca was served with a class-action antitrust
complaint filed in the US District Court for the Western District of New York
(District Court) by Mosaic Health alleging a conspiracy to restrict access to
340B discounts in the diabetes market through contract pharmacies. In
September 2022, the District Court granted AstraZeneca's motion to dismiss the
Complaint. In February 2024, the District Court denied Plaintiffs' request to
file a new amended complaint and entered an order closing the matter.
Caelum Trade Secrets Litigation
US proceedings
AstraZeneca has been defending a matter filed by the University of Tennessee
Research Foundation in the US District Court for the Eastern District of
Tennessee (District Court) related to CAEL-101. In October 2023, AstraZeneca
filed a motion for summary judgment on all claims and awaits a decision by the
District Court. Trial is currently scheduled for September 2024.
Definiens
Germany proceedings
In Germany, in July 2020, AstraZeneca received a notice of arbitration filed
with the German Institution of Arbitration from the sellers of Definiens AG
(Sellers) regarding the 2014 Share Purchase Agreement (SPA) between
AstraZeneca and the Sellers. The Sellers claim that they are owed
approximately $140m in earn-outs under the SPA. The arbitration hearing took
place in March 2023 and final post-hearing written briefs were submitted in
June 2023. In December 2023, the arbitration panel made a final award of
$46.43m in favour of the Sellers. AstraZeneca is considering its options.
Legal proceedings brought against AstraZeneca which have been concluded
Alexion Shareholder Litigation
US proceedings
In December 2016, putative securities class action lawsuits were filed in the
US District Court for the District of Connecticut (District Court) against
Alexion and certain officers and directors (collectively, defendants), on
behalf of purchasers of Alexion publicly traded securities during the period
30 January 2014 through 26 May 2017. The amended complaint alleged that
defendants engaged in securities fraud, including by making misrepresentations
and omissions in their public disclosures concerning Alexion's Soliris sales
practices, management changes, and related investigations. In August 2021, the
District Court issued a decision denying in part defendants' motion to dismiss
the matter. The Court granted plaintiffs' motion for class certification in
April 2023. In August 2023, the parties reached a settlement in principle of
this matter. In September 2023, the court granted preliminary approval of the
class settlement. A provision was taken in September 2023. The court granted
final approval of the class settlement in December 2023, and the matter is now
concluded.
Government investigations/proceedings
Legal proceedings brought against AstraZeneca considered to be contingent
liabilities
US Congressional Inquiry
US proceedings
In January 2024, AstraZeneca received a letter from the US Senate Committee on
Health, Education, Labor and Pensions (HELP Committee) seeking information
related to AstraZeneca's inhaled Respiratory products. AstraZeneca intends to
cooperate with the inquiry.
Legal proceedings brought against AstraZeneca which have been concluded
COVID-19 vaccine supply and manufacturing inquiries
Brazil proceedings
In February 2022, a Brazilian Public Prosecutor filed a lawsuit against
several defendants including the Brazilian Federal Government, AstraZeneca,
and other COVID-19 vaccine manufacturers. In April 2022, a Brazilian court
issued an order dismissing the lawsuit. In October 2023, the pending appeal
was dismissed. No further appeal was made. This matter is now concluded.
Other
Additional government inquiries
As is true for most, if not all, major prescription pharmaceutical companies,
AstraZeneca is currently involved in multiple inquiries into drug marketing
and pricing practices. In addition to the investigations described above,
various law enforcement offices have, from time to time, requested information
from the Group. There have been no material developments in those matters.
Taxation
As previously disclosed in the Annual Report and Form 20-F Information 2022
(https://www.astrazeneca.com/content/dam/az/Investor_Relations/annual-report-2022/pdf/AstraZeneca_AR_2022.pdf)
, AstraZeneca faces a number of audits and reviews in jurisdictions around the
world and, in some cases, is in dispute with the tax authorities. The issues
under discussion are often complex and can require many years to resolve.
Accruals for tax contingencies require management to make key judgements and
significant estimates with respect to the ultimate outcome of current and
potential future tax audits, and actual results could vary from these
estimates.
The total net accrual to cover the worldwide tax exposure for transfer pricing
disputes of $401m (31 December 2022: $260m) reflected the progress in those
tax audits and reviews during the year and for those audits where AstraZeneca
and tax authorities are in dispute, AstraZeneca estimates the potential for
reasonably possible additional liabilities above and beyond the amount
provided to be up to $386m, including associated interest (31 December 2022:
$245m).
The total net accrual to cover the worldwide tax exposure for other uncertain
tax treatments of $935m (31 December 2022: $570m) reflected the an update to
tax liabilities following progress of reviews by tax authorities and the
administrative appeals processes, and where AstraZeneca and tax authorities
are in dispute, AstraZeneca estimates the potential for reasonably possible
additional liabilities above and beyond the amount provided to be up to $293m,
including associated interest (31 December 2022: $209m).
Note 7
Table 27: FY 2023 - Product Sales year-on-year analysis
17 (#_ftn17)
The CER information in respect of FY 2023 included in the Consolidated
Financial Information has not been audited by PricewaterhouseCoopers LLP.
World US Emerging Markets Europe Established RoW
$m Act % chg CER % chg $m % chg $m Act % chg CER % chg $m Act % chg CER % chg $m Act % chg CER % chg
Oncology 17,145 17 20 7,719 19 3,828 8 16 3,332 22 20 2,266 20 29
Tagrisso 5,799 7 9 2,276 13 1,621 3 10 1,120 10 8 782 (8) (1)
Imfinzi 4,237 52 55 2,317 49 360 25 39 758 39 36 802 n/m n/m
Lynparza 2,811 7 9 1,254 2 542 11 21 734 12 10 281 5 12
Calquence 2,514 22 23 1,815 10 98 n/m n/m 493 72 69 108 58 65
Enhertu 261 n/m n/m - - 169 n/m n/m 60 n/m n/m 32 n/m n/m
Orpathys 44 34 42 - - 44 34 42 - - - - - -
Truqap 6 n/m n/m 6 n/m - - - - - - - - -
Zoladex 952 3 9 14 (4) 687 5 12 133 - (1) 118 (4) 2
Faslodex 297 (11) (6) 31 87 142 (11) (6) 28 (49) (50) 96 (7) 1
Others 224 (33) (30) 6 (44) 165 (34) (31) 6 (42) (41) 47 (28) (23)
BioPharmaceuticals: CVRM 10,585 15 18 2,752 11 4,586 11 18 2,503 31 29 744 9 16
Farxiga 5,963 36 39 1,451 35 2,211 33 40 1,881 45 42 420 21 30
Brilinta 1,324 (2) (1) 744 - 285 - 10 271 (4) (5) 24 (49) (47)
Lokelma 412 43 46 214 26 50 n/m n/m 58 94 91 90 32 42
roxadustat 271 38 45 - - 271 38 45 - - - - - -
Andexxa 182 21 23 75 (2) - - - 62 50 47 45 39 50
Crestor 1,107 6 11 55 (16) 862 9 15 52 26 25 138 (7) -
Seloken/Toprol-XL 640 (26) (20) 1 n/m 621 (26) (20) 11 (18) (17) 7 (23) (19)
Onglyza 227 (12) (8) 49 (36) 131 8 16 32 (16) (17) 15 (30) (28)
Bydureon 163 (42) (42) 133 (45) 3 12 12 27 (24) (26) - - -
Others 296 (19) (17) 30 (10) 152 (22) (18) 109 (15) (15) 5 (52) (49)
BioPharmaceuticals: R&I 6,107 6 8 2,547 (4) 1,771 23 31 1,164 10 8 625 2 8
Symbicort 2,362 (7) (4) 726 (25) 753 24 33 549 (6) (7) 334 (11) (7)
Fasenra 1,553 11 12 992 9 64 50 61 355 16 14 142 - 6
Breztri 677 70 73 383 60 161 75 85 81 n/m n/m 52 55 66
Saphnelo 280 n/m n/m 260 n/m 2 n/m n/m 8 n/m n/m 10 n/m n/m
Tezspire 86 n/m n/m - - 1 n/m n/m 48 n/m n/m 37 n/m n/m
Pulmicort 713 11 17 28 (58) 575 25 34 68 (1) (2) 42 (15) (10)
Bevespi 58 - - 34 (19) 6 19 28 17 65 62 1 50 14
Daliresp/Daxas 54 (72) (72) 42 (76) 3 (7) (11) 8 (9) (11) 1 (48) (20)
Others 324 (23) (20) 82 (42) 206 (10) (5) 30 (29) (30) 6 1 5
BioPharmaceuticals: V&I 1,012 (79) (78) 109 (91) 212 (84) (83) 396 (61) (62) 295 (76) (74)
COVID-19 mAbs 132 (94) (93) - n/m 6 (99) (99) 12 (96) (96) 114 (72) (68)
Vaxzevria 12 (99) (99) - n/m 10 (99) (99) 2 n/m (99) - n/m n/m
Beyfortus 106 n/m n/m 87 n/m - - - 19 n/m n/m - - -
Synagis 546 (6) (2) (1) n/m 195 13 19 175 (18) (18) 177 (7) (1)
FluMist 216 24 17 23 10 1 9 (2) 188 25 17 4 74 80
Rare Disease 7,764 10 12 4,701 9 623 45 62 1,529 7 5 911 5 12
Soliris 3,145 (16) (14) 1,734 (20) 424 41 63 670 (17) (18) 317 (33) (29)
Ultomiris 2,965 51 52 1,750 54 71 88 89 668 39 36 476 54 65
Strensiq 1,152 20 21 937 22 40 15 22 89 14 11 86 13 22
Koselugo 331 59 60 195 20 59 n/m n/m 53 n/m n/m 24 n/m n/m
Kanuma 171 7 8 85 10 29 (7) (1) 49 12 10 8 2 9
Other medicines 1,176 (28) (24) 133 (8) 731 (7) (1) 105 (14) (15) 207 (64) (61)
Nexium 945 (27) (22) 115 (5) 578 2 9 53 16 13 199 (64) (61)
Others 231 (32) (30) 18 (22) 153 (31) (28) 52 (33) (32) 8 (58) (55)
Total Product Sales 43,789 2 4 17,961 4 11,751 1 8 9,029 9 7 5,048 (14) (8)
Table 28: Q4 2023 - Product Sales year-on-year analysis
18 (#_ftn18)
The Q4 2023 information in respect of the three months ended 31 December 2023
included in the Consolidated Financial Information has not been audited by
PricewaterhouseCoopers LLP.
World US Emerging Markets Europe Established RoW
$m Act % chg CER % chg $m % chg $m Act % chg CER % chg $m Act % chg CER % chg $m Act % chg CER % chg
Oncology 4,453 19 19 2,067 16 904 11 18 903 31 22 579 28 32
Tagrisso 1,419 6 6 597 12 360 1 6 299 22 14 163 (21) (18)
Imfinzi 1,135 51 52 609 35 90 42 64 211 49 38 225 n/m n/m
Lynparza 741 8 8 352 6 133 2 13 191 18 10 65 (1) 2
Calquence 675 15 14 478 3 29 76 n/m 140 63 52 28 41 42
Enhertu 83 n/m n/m - - 48 n/m n/m 20 n/m n/m 15 n/m n/m
Orpathys 11 n/m n/m - - 11 n/m n/m - - - - - -
Truqap 6 n/m n/m 6 n/m - - - - - - - - -
Zoladex 254 20 23 2 (40) 167 12 16 35 5 (2) 50 n/m n/m
Faslodex 79 7 7 22 n/m 28 (26) (24) 6 (44) (49) 23 (3) 2
Others 50 (22) (19) 1 (66) 38 (16) (14) 1 (46) (42) 10 (28) (26)
BioPharmaceuticals: CVRM 2,698 18 18 780 12 1,078 15 19 679 38 28 161 5 8
Farxiga 1,606 36 35 451 39 559 27 31 525 54 43 71 - 3
Brilinta 329 (5) (4) 194 (6) 61 (5) 8 68 1 (6) 6 (26) (27)
Lokelma 112 38 38 58 21 13 n/m n/m 17 85 73 24 31 37
roxadustat 63 28 28 - - 63 28 28 - - - - - -
Andexxa 53 35 34 18 24 - - - 18 45 36 17 37 43
Crestor 247 10 12 15 (3) 184 13 15 11 (5) (10) 37 9 13
Seloken/Toprol-XL 144 (8) (3) - - 139 (8) (2) 3 (17) (15) 2 (34) (35)
Onglyza 47 (9) (7) 5 (71) 31 40 48 8 (11) (17) 3 (32) (32)
Bydureon 39 (46) (47) 32 (51) - (1) 4 7 3 (7) - - -
Others 58 (30) (31) 7 2 28 (33) (33) 22 (31) (32) 1 (53) (51)
BioPharmaceuticals: R&I 1,590 10 10 647 (6) 456 34 41 317 22 14 170 10 12
Symbicort 520 (16) (16) 137 (46) 153 15 21 142 3 (4) 88 (7) (6)
Fasenra 420 10 9 275 7 16 22 43 93 22 14 36 4 6
Breztri 199 72 72 120 60 38 80 79 26 n/m n/m 15 78 89
Saphnelo 89 86 86 82 80 1 - - 3 n/m n/m 3 n/m n/m
Tezspire 35 n/m n/m - - 1 n/m n/m 20 n/m n/m 14 n/m n/m
Pulmicort 219 32 40 5 (54) 183 50 61 19 (1) (9) 12 (3) (1)
Bevespi 15 6 4 9 (9) 1 10 12 5 54 44 - - -
Daliresp/Daxas 13 (56) (55) 10 (60) 1 49 (13) 2 (12) (18) - - -
Others 80 13 14 9 (26) 62 25 26 7 (5) (11) 2 17 18
BioPharmaceuticals: V&I 345 (69) (70) 59 (74) 31 (90) (90) 195 (42) (45) 60 (76) (75)
COVID-19 mAbs 6 (99) (99) - n/m 1 n/m n/m 5 (95) (95) - n/m n/m
Vaxzevria (17) n/m n/m - - (8) n/m n/m (9) n/m n/m - - -
Beyfortus 54 n/m n/m 52 n/m - - - 2 n/m n/m - - -
Synagis 164 (16) (16) - (36) 37 29 37 67 (26) (31) 60 (21) (19)
FluMist 138 20 11 7 (27) 1 31 17 130 24 15 - - -
Rare Disease 1,971 9 9 1,232 7 136 18 46 364 4 (3) 239 18 22
Soliris 715 (15) (13) 421 (14) 86 4 36 140 (22) (28) 68 (25) (24)
Ultomiris 825 39 38 490 34 24 n/m n/m 173 29 19 138 52 58
Strensiq 305 12 13 247 10 11 17 40 25 30 22 22 17 22
Koselugo 85 46 48 51 7 10 n/m n/m 15 n/m n/m 9 n/m n/m
Kanuma 41 (17) (14) 23 6 5 (68) (58) 11 9 5 2 (1) 1
Other medicines 266 (30) (28) 29 (9) 151 (16) (13) 38 36 34 48 (66) (65)
Nexium 209 (30) (28) 26 - 120 (9) (4) 17 91 76 46 (65) (65)
Others 57 (28) (27) 3 (48) 31 (37) (36) 21 11 14 2 (69) (68)
Total Product Sales 11,323 5 5 4,814 5 2,756 2 8 2,496 16 8 1,257 (7) (4)
Table 29: Alliance Revenue
FY 2023 FY 2022
$m $m
Enhertu 1,022 523
Tezspire 259 79
Beyfortus 57 -
Vaxzevria: royalties - 76
Other royalty income 81 68
Other Alliance Revenue 9 9
Total 1,428 755
Table 30: Collaboration Revenue
FY 2023 FY 2022
$m $m
Lynparza: regulatory milestones 245 355
COVID-19 mAbs: licence fees 180 -
Farxiga: sales milestones 29 -
tralokinumab: sales milestones 20 110
Beyfortus: regulatory milestones 71 25
Beyfortus: sales milestone 27 -
Nexium: sale of rights - 62
Other Collaboration Revenue 22 46
Total 594 598
Table 31: Other operating income and expense
FY 2023 FY 2022
$m $m
brazikumab licence termination funding 75 138
Divestment of rights to Plendil - 61
Divestment of US rights to Pulmicort Flexhaler 241 -
Update to the contractual relationships for Beyfortus (nirsevimab) 712 -
Waltham site gain on sale and leaseback - 125
Other 312 190
Total 1,340 514
Other shareholder information
Financial calendar
Announcement of first quarter 2024 results:
25 April 2024
Announcement of first half and second quarter 2024 results: 25 July
2024
Announcement of nine months and third quarter 2024 results: 12 November
2024
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
Provisional dates for the 2023 second interim dividend: ex-dividend 22
February 2024, record date 23 February 2024, payable on 25 March 2024.
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
Registered office Registrar and transfer office Swedish Central Securities Depository US depositary
Deutsche Bank Trust Company Americas
1 Francis Crick Avenue Equiniti Limited Euroclear Sweden AB PO Box 191 American Stock Transfer
Cambridge Biomedical Campus Aspect House SE-101 23 Stockholm 6201 15th Avenue
Cambridge Spencer Road Brooklyn
CB2 0AA Lancing NY 11219
West Sussex
BN99 6DA
United Kingdom United Kingdom Sweden United States
+44 (0) 20 3749 5000 0800 389 1580 +46 (0) 8 402 9000 +1 (888) 697 8018
+44 (0) 121 415 7033 +1 (718) 921 8137
db@astfinancial.com (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: FasT
CAR owned by Gracell Biotechnology, Co., Ltd.; Plendil owned by AstraZeneca or
Glenwood GmbH (depending on geography); Beyfortus, a trademark of Sanofi
Pasteur Inc.; Enhertu, a trademark of Daiichi Sankyo; 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 Social Media @AstraZeneca
(https://www.linkedin.com/company/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 Icosavax to complete the transactions
contemplated by the merger agreement with Icosavax, including the parties'
ability to satisfy the conditions to the consummation of the tender offer
contemplated thereby and the other conditions set forth in the merger
agreement with Icosavax;
‒ the ability of the Group and Gracell to complete the transactions
contemplated by the merger agreement with Gracell, including the parties'
ability to satisfy the conditions set forth in the merger agreement with
Gracell;
‒ the Group's statements about the expected timetable for completing
the acquisitions of Icosavax and Gracell;
‒ The Group's and Icosavax's beliefs and expectations and statements
about the benefits sought to be achieved in the Group's pending acquisition of
Icosavax;
‒ the Group's and Gracell's beliefs and expectations and statements
about the benefits sought to be achieved in the Group's proposed acquisition
of Gracell;
‒ the potential effects of the acquisition of Icosavax on both the
Group and Icosavax and of the acquisition of Gracell on both the Group and
Gracell;
‒ the possibility of any termination of the merger agreement with
Icosavax or of the merger agreement with Gracell;
‒ the expected benefits and success of IVX-A12 and any combination
product or GC012F and any combination product;
‒ the possibility that any milestone related to any 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 the Group's 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 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 Icosavax will be satisfied on
the expected timetable or at all or that IVX-A12 or any further vaccines using
the VLP technology will receive the necessary regulatory approvals or prove to
be commercially successful if approved. There can be no guarantees that the
conditions to the closing of the proposed transaction with Gracell will be
satisfied on the expected timetable or at all or that GC012F will receive the
necessary regulatory approvals or prove to be commercially successful if
approved.
Glossary
1L, 2L, etc First line, second line, etc
ADC Antibody drug
conjugate
aHUS Atypical haemolytic
uraemic syndrome
AKT Protein kinase B
AL amyloidosis Light chain amyloidosis
ANDA Abbreviated New Drug
Application (US)
ASO Antisense
oligonucleotide
ATTR-CM Transthyretin-mediated amyloid
cardiomyopathy
ATTRv / -PN / -CM Hereditary transthyretin-mediated amyloid /
polyneuropathy / cardiomyopathy
BCMA B-cell maturation
antigen
BRCA / m Breast cancer gene / mutation
BTC Biliary tract
cancer
BTK Bruton tyrosine
kinase
C5 Complement
component 5
CAR-T Chimeric antigen
receptor T-cell
CD19 A gene expressed in
B-cells
CER Constant exchange
rates
CHMP Committee for Medicinal
Products for Human Use (EU)
CI
Confidence interval
CKD Chronic kidney
disease
CLL Chronic
lymphocytic leukaemia
COPD Chronic obstructive
pulmonary disease
COP28 28th annual United Nations
(UN) climate meeting
CRC Colorectal cancer
CRL Compete Response
Letter
CRPC Castration-resistant
prostate cancer
CSPC Castration-sensitive
prostate cancer
CTLA-4 Cytotoxic
T-lymphocyte-associated antigen 4
CVRM Cardiovascular, Renal
and Metabolism
DDR DNA damage
response
DNA Deoxyribonucleic
acid
EBITDA Earnings before interest,
tax, depreciation and amortisation
EGFR m Epidermal growth factor
receptor / mutation
EGPA Eosinophilic
granulomatosis with polyangiitis
EPS Earnings per
share
ERBB2 v-erb-b2 avian
erythroblastic leukaemia viral oncogene homologue 2
FDA Food and Drug
Agency (US)
FDC Fixed dose
combination
g
Germline, e.g. gBRCAm
GAAP Generally Accepted
Accounting Principles
GEJ Gastro
oesophageal junction
GI
Gastrointestinal
GLP1 / -RA Glucagon-like peptide-1 /
receptor agonist
gMG Generalised
myasthenia gravis
HCC Hepatocellular
carcinoma
HER2 / +/- / low / m Human epidermal growth factor receptor 2 / positive /
negative / low level expression / mutant
HF/ pEF / rEF Heart failure / with preserved ejection
fraction / with reduced ejection fraction
hMPV Human metapneumovirus
HR / + / - Hormone receptor /
positive / negative
HRD Homologous
recombination deficiency
HRRm Homologous
recombination repair gene mutation
i.m. Intramuscular
injection
i.v.
Intravenous injection
IAS / B International
Accounting
Standards / Board
ICS Inhaled
corticosteroid
IFRS International
Financial Reporting Standards
IgAN Immunoglobulin A
neuropathy
IHC
Immunohistochemistry
IL-5, IL-33, etc Interleukin-5, Interleukin-33, etc
IP
Intellectual Property
IVIg Intravenous
immune globulin
LABA Long-acting
beta-agonist
LAMA Long-acting
muscarinic-agonist
LRTD Lower respiratory
tract disease
m
Metastatic, e.g. mBTC , mCRPC, mCSPC
mAb Monoclonal
antibody
MDL multidistrict litigation
MET Mesenchymal
epithelial transition
NF1-PN Neurofibromatosis type 1
with plexiform neurofibromas
NMOSD Neuromyelitis optica
spectrum disorder
NRDL National
reimbursement drug list
NSCLC Non-small cell lung cancer
OECD Organisation for
Economic Co-operation and Development
OOI Other
operating income
ORR Overall response
rate
OS Overall
survival
PARP / -1sel Poly ADP ribose polymerase /-1
selective
pCR Pathologic
complete response
PCSK9 Proprotein convertase
subtilisin/kexin type 9
PD Progressive
disease
PD-1 Programmed cell
death protein 1
PD-L1 Programmed cell death
ligand 1
PDUFA Prescription Drug User Fee
Act
PHSSR Partnership for Health System
Sustainability and Resilience
PFS Progression free
survival
PIK3CA
Phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha
PMDI Pressure metered
dose inhaler
PNH / -EVH Paroxysmal nocturnal haemoglobinuria
/ with extravascular haemolysis
PPI Proton pump
inhibitors
PSR Platinum
sensitive relapse
PTEN Phosphatase and
tensin homologue
Q3W, Q4W, etc Every three weeks, every four weeks, etc
R&D Research and
development
R&I
Respiratory & Immunology
RSV Respiratory
syncytial virus
sBLA Supplemental
biologics license application (US)
SCLC Small cell lung
cancer
s.c.
Subcutaneous injection
SEA Severe
eosinophilic asthma
SEC Securities
Exchange Commission (US)
SG&A Sales, general
and administration
SGLT2 Sodium-glucose
cotransporter 2
SLL Small
lymphocytic lymphoma
SMI Sustainable Markets
Initiative
SPA Share Purchase
Agreement
T2D Type-2 diabetes
TACE Transarterial
chemoembolization
TNBC Triple negative
breast cancer
TNF Tumour necrosis
factor
TOP1 Topoisomerase I
TROP2 Trophoblast cell surface
antigen 2
USPTO US Patent and Trademark Office
V&I Vaccines
& Immune Therapies
VBP Volume-based
procurement
VLP Virus like
particle
- 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 2023
vs. 2022. 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) Effective 1 January 2023, the Group has updated the
presentation of Total Revenue. For further details of the presentation of
Alliance Revenue and Collaboration Revenue, see the Basis of preparation and
accounting policies section of the Notes to the Condensed consolidated
financial statements section.
3 (#_ftnref3) 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, legal settlements and restructuring charges. A full
reconciliation between Reported EPS and Core EPS is provided in Table 13 and
Table 14 in the Financial performance section of this document.
4 (#_ftnref4) The COVID-19 medicines are Vaxzevria, Evusheld, and sipavibart
(AZD3152) - the COVID-19 antibody currently in development.
5 (#_ftnref5) The calculation of Reported and Core Product Sales Gross
Margin (formerly termed as Gross Margin) excludes the impact of Alliance
Revenue and Collaboration Revenue.
6 (#_ftnref6) In Table 2, the plus and minus symbols denote the directional
impact of the item being discussed, e.g. a '+' symbol next to an R&D
expense comment indicates that the item increased the R&D expense relative
to the prior year.
7 (#_ftnref7) Income from disposals of assets and businesses, where the
Group does not retain a significant ongoing economic interest, continue to be
recorded in Other operating income and expense in the Company's financial
statements.
8 (#_ftnref8) Partnered with BridgeBio Pharma Inc (BridgeBio) - AstraZeneca
has rights to commercialise acamoridis in Japan
9 (#_ftnref9) Product Sales shown in the Imfinzi line include Product Sales
from Imjudo
10 (#_ftnref10) 'New-to-brand' share represents a medicine's share in the
dynamic market.
11 (#_ftnref11) Other adjustments include fair value adjustments and
discount unwind, relating to contingent consideration on business
combinations, Other payables arising from intangibles asset acquisitions,
other acquisition-related liabilities (see Note 4) and provision movements
related to certain legal matters. These legal matters include a $510m charge
to provisions relating to a legal settlement with BMS and Ono and a $425m
charge to provisions relating to a multidistrict litigation proceeding legal
settlement in FY 2023 (see Note 6).
12 (#_ftnref12) Based on best prevailing assumptions around currency
profiles.
13 (#_ftnref13) Based on average daily spot rates 1 Jan 2023 to 31 Dec 2023.
14 (#_ftnref14) Based on average daily spot rates 1 Jan 2024 to 31 Jan 2024.
15 (#_ftnref15) Other currencies include AUD, BRL, CAD, KRW and RUB.
16 (#_ftnref16) Effective 1 January 2023, the Group updated the presentation
of Total Revenue. See Note 1 for further details of the presentation of
Alliance Revenue.
17 (#_ftnref17) 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.
18 (#_ftnref18) 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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