0001654954-24-001467.txt : 20240208 0001654954-24-001467.hdr.sgml : 20240208 20240208064042 ACCESSION NUMBER: 0001654954-24-001467 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20240208 FILED AS OF DATE: 20240208 DATE AS OF CHANGE: 20240208 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ASTRAZENECA PLC CENTRAL INDEX KEY: 0000901832 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 000000000 STATE OF INCORPORATION: X0 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-11960 FILM NUMBER: 24606794 BUSINESS ADDRESS: STREET 1: 1 FRANCIS CRICK AVENUE STREET 2: CAMBRIDGE BIOMEDICAL CAMPUS CITY: CAMBRIDGE STATE: X0 ZIP: CB2 0AA BUSINESS PHONE: 011 44 20 7304 5000 MAIL ADDRESS: STREET 1: 1 FRANCIS CRICK AVENUE STREET 2: CAMBRIDGE BIOMEDICAL CAMPUS CITY: CAMBRIDGE STATE: X0 ZIP: CB2 0AA FORMER COMPANY: FORMER CONFORMED NAME: ZENECA GROUP PLC DATE OF NAME CHANGE: 19930422 6-K 1 a4081c.htm FINAL RESULTS a4081c

FORM 6-K
 
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
Report of Foreign Issuer
 
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
 
For the month of February 2024
 
Commission File Number: 001-11960
 
AstraZeneca PLC
 
1 Francis Crick Avenue
Cambridge Biomedical Campus
Cambridge CB2 0AA
United Kingdom
 
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
 
Form 20-F X Form 40-F __
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______
 
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
 
Yes __ No X
 
If “Yes” is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b): 82-_____________
 
 
 
 
 
 
 
AstraZeneca PLC
 
INDEX TO EXHIBITS
 
 
1. Final Results
 
 
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]
$m 
Actual 
CER 
- Product Sales
 
43,789 
11,323 
- Alliance Revenue[2]
 
1,428 
89 
89 
424 
69 
67 
- Collaboration Revenue2
 
594 
(1)
(1)
277 
75 
74 
Total Revenue
 
45,811 
12,024 
Total Revenue ex COVID-19
 
45,488 
13 
15 
12,036 
16 
16 
Reported EPS
 
$3.84 
81 
96 
$0.62 
Core[3] EPS
 
$7.26 
15 
$1.45 
 
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]
 
‒    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] 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 .
 
Table 1: Key elements of Total Revenue performance in Q4 2023
 
 
% Change 
 
 
 
Revenue type 
 
$m 
Actual % 
CER % 
 
 
Product Sales 
 
11,323 
 
 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 
 
 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 
 
 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 
 
 
Regions inc. COVID-19
 
$m 
Actual %
CER %
 
 
US 
 
5,101 
 
 
Emerging Markets 
 
2,783 
 
 
- China 
 
1,382 
16 
16 
 
 
- Ex-China Emerging Markets 
 
1,401 
(9)
 
 
Europe 
 
2,880 
25 
17 
 
 
Established RoW 
 
1,259 
(9)
(6)
 
 
Total Revenue inc. COVID-19  
 
12,024 
 
 Growth rates impacted by lower sales ofCOVID---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 
 
 
Total Revenue ex. COVID-19
 
12,036 
16 
16 
 
 
 
Table 2: Key elements of financial performance in Q4 2023

Metric
 
Reported
Reported change
Core
Corechange
 
Comments[6]
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]
$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 (CAPItello-291)
Regulatory approval (US)
 
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 submissionsor acceptances*
Lynparza
gBRCA breast cancer (adjuvant) (OlympiA)
Regulatory submission (CN)
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]
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.
 
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 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.
 
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.
 
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 
1,419 
12 
Imfinzi [9]
 
4,237 
52 
55 
1,135 
51 
52 
Lynparza 
 
2,811 
741 
Calquence
 
2,514 
22 
23 
675 
15 
14 
Enhertu
 
261 
>3x 
>3x 
83 
>2x 
>3x 
Orpathys 
 
44 
34 
42 
11 
n/m 
n/m 
Truqap
 
n/m 
n/m 
n/m 
n/m 
Zoladex 
 
952 
254 
20 
23 
Faslodex 
 
297 
(11)
(6)
79 
- 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 
(2)
(1)
329 
(5)
(4)
Lokelma 
 
412 
43 
46 
112 
38 
38 
- roxadustat 
 
271 
38 
45 
63 
28 
28 
Andexxa
 
182 
21 
23 
53 
35 
34 
Crestor 
 
1,107 
11 
247 
10 
12 
Seloken/Toprol-XL 
 
640 
(26)
(20)
144 
(8)
(3)
- Onglyza
 
227 
(12)
(8)
47 
(9)
(7)
- Bydureon
 
163 
(42)
(42)
39 
(46)
(47)
- Others 
 
296 
(19)
(17)
58 
(30)
(31)
BioPharmaceuticals: R&I 
 
6,107 
13 
1,590 
13 
10 
10 
Symbicort 
 
2,362 
(7)
(4)
520 
(16)
(16)
Fasenra
 
1,553 
11 
12 
420 
10 
Breztri  
 
677 
70 
73 
199 
72 
72 
Saphnelo 
 
280 
>2x 
>2x 
89 
86 
86 
Tezspire 
 
86 
>10x 
>10x 
35 
>9x 
>8x 
Pulmicort 
 
713 
11 
17 
219 
32 
40 
Bevespi
 
58 
-
-
15 
Daliresp/Daxas 
 
54 
(72)
(72)
13 
(56)
(55)
- Others 
 
324 
(23)
(20)
80 
13 
14 
BioPharmaceuticals: V&I 
 
1,012 
(79)
(78)
345 
(69)
(70)
- COVID-19 mAbs
 
132 
(94)
(93)
(99)
(99)
Vaxzevria 
 
12 
(99)
(99)
(17)
n/m 
n/m 
Beyfortus
 
106 
n/m 
n/m 
54 
n/m 
n/m 
Synagis
 
546 
(6)
(2)
164 
(16)
(16)
FluMist
 
216 
24 
17 
138 
20 
11 
Rare Disease
 
7,764 
17 
10 
12 
1,971 
16 
- Soliris
 
3,145 
(16)
(14)
715 
(15)
(13)
- Ultomiris 
 
2,965 
51 
52 
825 
39 
38 
- Strensiq 
 
1,152 
20 
21 
305 
12 
13 
Koselugo 
 
331 
59 
60 
85 
46 
48 
Kanuma 
 
171 
41 
(17)
(14)
Other medicines 
 
1,176 
(28)
(24)
266 
(30)
(28)
Nexium 
 
945 
(27)
(22)
209 
(30)
(28)
- Others
 
231 
(32)
(30)
57 
(28)
(27)
Product Sales 
 
43,789 
96 
11,323 
94 
Alliance Revenue
 
1,428 
89 
89 
424 
69 
67 
Collaboration Revenue 
 
594 
(1)
(1)
277 
75 
74 
Total Revenue
 
45,811 
100 
12,024 
100 
 
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 
n/m
n/m
41 
10 
n/m
n/m
Vaxzevria: royalties
 
n/m
n/m
n/m
n/m
Other royalty income
 
81 
18 
18 
21 
25 
27 
Other Alliance Revenue 
 
>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 
n/m
n/m
n/m
n/m
tralokinumab: sales milestones 
 
20 
(82)
(82)
Beyfortus: regulatory milestones 
 
71 
12 
>2x
>2x
n/m
n/m
Beyfortus: sales milestone
 
27 
n/m
n/m
27
10 
n/m
n/m
Other Collaboration Revenue 
 
22 
(52)
(52)
(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 
10 
1,675 
14 
13 
13 
- V&I 
 
1,357 
(72)
(71)
413 
(64)
(66)
Rare Disease
 
7,764 
17 
10 
12 
1,971 
16 
Other Medicines 
 
1,211 
(31)
(27)
274 
(33)
(32)
Total
 
45,811 
100 
12,024 
100 
 
Table 9: Total Revenue by region
 
 
 
 
FY 2023 
Q4 2023
 
 
 
 
% Change 
 
 
% Change
 
 
$m 
% Total 
 Actual 
CER 
$m 
% Total 
 Actual 
CER 
US
 
19,077 
42 
5,101 
42 
Emerging Markets 
 
12,025 
26 
2,783 
23 
- China 
 
5,876 
13 
1,382 
11 
16 
16 
- Ex-China 
 
6,148 
13 
11 
1,401 
12 
(9)
Europe 
 
9,611 
21 
10 
2,880 
24 
25 
17 
Established RoW 
 
5,099 
11 
(14)
(8)
1,259 
10 
(9)
(6)
Total 
 
45,811 
100 
12,024 
100 
 
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 
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 
1,259 
10 
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 FasenraTezspireBreztri 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] 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 
12,024 
11,207 
- Product Sales
 
43,789 
42,998 
11,323 
10,798 
- 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)
(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)
(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)
(337)
(315)
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 
Earnings per share
 
$3.84 
$2.12 
81 
96 
$0.62 
$0.58 
 
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 
337 
315 
Joint ventures and associates 
 
12 
>2x
>2x
(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
Acquisitionof Alexion
Other[11]
Core
Core
% Change
 
 
 
 
$m 
$m 
$m 
$m 
$m 
$m 
Actual 
CER 
Gross profit
 
37,543 
109 
32 
119 
(3)
37,800 
Product Sales Gross Margin
 
81.1% 
 
 
 
 
81.7% 
+2pp 
+2pp 
Distribution expense
 
(539)
(539)
R&D expense
 
(10,935)
212 
447 
(10,267)
SG&A expense
 
(19,216)
207 
3,801 
11 
1,458 
(13,739)
Total operating expense
 
(30,690)
419 
4,248 
18 
1,460 
(24,545)
Other operating income & expense
 
1,340 
(61)
1,279 
>2x
>2x
Operating profit
 
8,193 
467 
4,280 
137 
1,457 
14,534 
14 
Operating Margin
 
17.9% 
 
 
 
 
31.7% 
+2pp 
+2pp 
Net finance expense
 
(1,282)
298 
(984)
(1)
Taxation
 
(938)
(107)
(809)
(32)
(405)
(2,291)
11 
17 
EPS
 
$3.84 
$0.23 
$2.24 
$0.07 
$0.88 
$7.26 
15 
 
Table 14: Reconciliation of Reported to Core financial measures: Q4 2023
 
Q4 2023
 
Reported
Restructuring
Intangible Asset Amortisation & Impairments
Acquisitionof Alexion
Other
Core
Core
% Change
 
 
 
 
$m 
$m 
$m 
$m 
$m 
$m 
Actual 
CER 
Gross profit
 
9,716 
(24)
37 
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 
(2,914)
15 
14 
SG&A expense
 
(5,371)
44 
938 
351 
(4,034)
13 
12 
Total operating expense
 
(8,589)
139 
999 
352 
(7,093)
13 
12 
Other operating income & expense
 
107 
107 
(17)
(15)
Operating profit
 
1,234 
115 
1,007 
43 
353 
2,752 
Operating Margin
 
10.3% 
 
 
 
 
22.9% 
Net finance expense
 
(337)
- 
- 
- 
78 
(259)
Taxation
 
62 
(26)
(192)
(10)
(76)
(242)
EPS
 
$0.62 
$0.06 
$0.53 
$0.02 
$0.22 
$1.45 
 
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, EnhertuTezspire, 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
business combinations
 
549 
82 
467 
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 
 Dec 2023 
At 31 
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
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
rates vs. USD
 
Annual impact ($m) of 5% strengthening (FY 2024 average rate vs. FY 2023 average) [12]
 
 
Currency
Primary Relevance
 
FY    2023[13]
 
YTD   2024[14]
 
Change
 (%)
 
Total Revenue
Core Operating Profit
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]
 
 
 
 
 
 
 
 
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. 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 (PIK3CAAKT1 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]
 
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)